AK 200™ S / AK 200™ ULTRA S Dialysis Machine Service Manual Order number: MHCEN9281-10/12 HCEN9281 Revision 10.2012 Copyright: Copyright © 2001-2003, 2005, 2007, 2009, 2010, 2012 Gambro Lundia AB. Trademarks: Gambro, AK 200 S, AK 200 ULTRA S, BiCart, BiCart Select, CleanCart, Diascan, Exalis, SelectBag, and SelectCart are trademarks belonging to the Gambro Group. PEEK is a trademark of Victrex plc. Dialox is a trademark of L'Air Liquide. Manufacturer: Gambro Lundia AB Box 10101 Magistratsvägen 16 SE-220 10 LUND Sweden Phone +46 46 169000 www.gambro.com Sales representative contact information, (if applicable): Questions or comments about this publication can be directed to your local representative or to the manufacturer. HCEN9281 Revision 10.2012 AK 200™ S / AK 200™ ULTRA S Service Manual 1. General information 2. Installation Guide 3. Maintenance manual 4. Replacements 5. Maintenance support description 6. Technical description 7. Technical data and specifications - AK 200™ S dialysis machine 8. Technical data and specifications - AK 200™ ULTRA S dialysis machine 9. Electrical safety inspection 10. Wiring diagram 11. Calibration manual 12. FM flow diagrams HCEN9281 Revision 10.2012 Contents 1. General information About this manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Valid revision of AK 200™ S / AK 200™ ULTRA S - Service Manual . . . . . Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Complaint . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Disclaimer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Competence of Service Engineers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Technical support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Waste disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . List of symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:2 1:3 1:4 1:4 1:4 1:5 1:5 1:5 1:6 1:6 1:7 2. Installation Guide Before installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Qualification requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Tools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Manufacturer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Unpacking and inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Environment and Physical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Operating Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Transport and Storage Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Physical data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Mains Voltage and Power Consumption . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Power supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Service Outlets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Line Fuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Mains Water Supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Drain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 V Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Back-up Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Assembling the Monitor Stand . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . MS 200 - Adjustable height: five fixed positions . . . . . . . . . . . . . . . . . . . . . . . . MS 200 - Adjusted for installation of WRO 300 / WRO 300 H . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . MS 202 - Adjustable height: continuous variable . . . . . . . . . . . . . . . . . . . . . . . . Positioning the dialysis machine on the stand . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Installation instructions for AK 200™ S dialysis machine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ............................................................. Installation instructions for AK 200™ ULTRA S dialysis machine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ............................................................. Initial start-up procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . First check: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Start-up procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Service reporting - installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Checklist - Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2:2 2:2 2:2 2:2 2:3 2:4 2:4 2:4 2:5 2:6 2:6 2:6 2:6 2:7 2:8 2:9 2:9 2:9 2:11 2:11 2:12 2:16 2:21 2:26 2:28 2:28 2:34 2:34 2:42 2:42 2:42 2:44 2:45 HCEN9281 Revision 10.2012 3. Maintenance manual General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Test equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Preventive Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Base-kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . How to exchange the parts included in the Base-kit . . . . . . . . . . . . . . . . . . . Actions to carry out after the parts have been exchanged . . . . . . . . . . . . . . . Supplementary A-kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . How to exchange the exterior parts included in the A-kit . . . . . . . . . . . . . . . Actions to carry out after the parts have been exchanged . . . . . . . . . . . . . . . Supplementary B-kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . How to exchange the overhaul parts included in the B-kit . . . . . . . . . . . . . . . Actions to carry out after the parts have been exchanged . . . . . . . . . . . . . . . Test after defibrillator use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Actions, test after defibrillator use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:2 3:3 3:4 3:4 3:4 3:5 3:9 3:35 3:35 3:36 3:37 3:39 3:39 3:40 3:42 3:43 3:43 4. Replacements General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Replacement of components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ............................................................. Change actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Replacement of Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . List of batteries in AK 200™ S and AK 200™ ULTRA S dialysis machines . . . . Battery and electronic waste handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Replacement of power supply cord . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:2 4:3 4:3 4:5 4:7 4:7 4:7 4:8 5. Maintenance support description Operator's panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Treatment overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Parameter buttons and displays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Stand-by group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Alarm buttons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Display and setting group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Viewing trends on the screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Colours in parameter displays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Light intensity adjustment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Light intensity on old panels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Bargraph contrast . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Backlight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Treatment overview screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Parameters shown on Treatment overview screen . . . . . . . . . . . . . . . . . . . . . Functional check overview screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Tests shown on Functional check overview screen . . . . . . . . . . . . . . . . . . . . Maintenance support overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Access the Maintenance Support Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . To Exit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Logging mode overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Logging mode flow diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . HCEN9281 Revision 10.2012 5:2 5:4 5:4 5:5 5:5 5:6 5:6 5:7 5:8 5:9 5:9 5:9 5:10 5:11 5:12 5:13 5:14 5:14 5:14 5:15 5:16 Arrays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Flow Diagrams, FM with S-variables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Logging diagram, S-variables for BM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . How to enter/exit Service/Preset mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Preset mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PC Preset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Others . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Language version . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Time settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Total default . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Start up mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Preset of concentrates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Service mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Service mode flow diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Blood monitor flow diagram, calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . Fluid monitor flow diagram, calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . Diagnostic flow diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Error Buffers flow diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Diagnostics BM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Diagnostics FM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Utility flow diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ExalisⓇ flow diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Download new program version . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Procedure: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:17 5:18 5:21 5:22 5:23 5:23 5:24 5:25 5:25 5:25 5:26 5:28 5:30 5:33 5:34 5:35 5:36 5:37 5:38 5:39 5:40 5:41 5:42 5:43 5:43 6. Technical description Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Main functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Quick preparation procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Treatment flexibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Others . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Fluid Monitor, FM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . FM flow diagram AK 200™ ULTRA S dialysis machine . . . . . . . . . . . . . . . . . . Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Water intake . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Concentrate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Concentrate - FM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . BiCart SelectⓇ System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Dialysis Fluid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Design and Construction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . FM valves . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Electrical circuit boards used in the fluid monitor . . . . . . . . . . . . . . . . . . . . . . . FM CPU board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . FM Analog Distribution board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . FM Power Distribution board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Blood leak Detector board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Conductivity cell board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Blood pressure monitor board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:3 6:3 6:5 6:5 6:5 6:5 6:5 6:5 6:6 6:7 6:8 6:9 6:9 6:9 6:10 6:10 6:11 6:16 6:24 6:27 6:27 6:30 6:30 6:30 6:31 6:31 HCEN9281 Revision 10.2012 Blood Monitor, BM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Double Needle Treatment - HD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Single Needle Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Single Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Double Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Double Needle Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . HDF Low Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . HDF on line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . HF on line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Design and Construction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Level Detector (Air detector) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Blood Pump Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . BVS - Blood Volume Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Drip Chamber Level Adjustment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Fan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Heparin Pump Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Line Clamp Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Operator's Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Pressure Transducers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Priming Detector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . BPM - Blood Pressure Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Electrical circuit boards used in the blood monitor . . . . . . . . . . . . . . . . . . . . . . . BM Analog Distribution Board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Panel Control Board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . BM CPU Board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Power Supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Monitor stand . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:32 6:33 6:33 6:34 6:34 6:34 6:36 6:36 6:36 6:36 6:38 6:38 6:38 6:38 6:38 6:39 6:39 6:39 6:39 6:39 6:40 6:40 6:40 6:42 6:42 6:43 6:44 6:46 6:48 7. Technical data and specifications - AK 200™ S dialysis machine Performance and specification - Control System . . . . . . . . . . . . . . . . . . . . . . . . . . . Blood Flow Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Air Detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Heparin Administration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Blood Volume Sensor (BVS) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Blood Pressure Monitor (BPM) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Dialysis fluid preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Dialysis fluid preparation (BiCart SelectⓇ concentrate system mode only) . . Ultrafiltration control (Volume control) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Profiling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . DiascanⓇ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Disinfection and Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Water supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Drain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Power supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Connection of external equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Battery Back-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Performance and specification - Supervisory system . . . . . . . . . . . . . . . . . . . . . . . . Blood Pressure Supervision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Air Detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Heparin Administration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Dialysis fluid preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . HCEN9281 Revision 10.2012 7:2 7:2 7:3 7:3 7:3 7:4 7:5 7:6 7:6 7:6 7:7 7:8 7:11 7:12 7:12 7:12 7:14 7:15 7:15 7:16 7:16 7:16 Dialysis fluid preparation (BiCart SelectⓇ concentrate system mode only) . . Ultrafiltration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Blood leak detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Blood loss due to coagulation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Physical data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Materials in contact with water, concentrates and dialysis fluid . . . . . . . . . . . . . . . . Polymers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Metals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Others . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Environmental data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Transportation and storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Energy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Electromagnetic environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7:16 7:17 7:17 7:17 7:18 7:18 7:19 7:19 7:19 7:19 7:20 7:20 7:20 7:20 7:21 7:25 8. Technical data and specifications - AK 200™ ULTRA S dialysis machine Performance and specification - Control System . . . . . . . . . . . . . . . . . . . . . . . . . . . Blood Flow Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Air Detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Heparin Administration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Blood Volume Sensor (BVS) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Blood Pressure Monitor (BPM) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Dialysis fluid preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Dialysis fluid preparation (BiCart SelectⓇ concentrate system mode only) . . Ultrafiltration control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Substitution fluid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Profiling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . DiascanⓇ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Disinfection and Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Water supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Drain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Power supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Connection of external equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Battery Back-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Performance and specification - Supervisory system . . . . . . . . . . . . . . . . . . . . . . . . Blood Pressure Supervision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Air Detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Heparin Administration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Dialysis fluid preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Dialysis fluid preparation (BiCart SelectⓇ concentrate system mode only) . . Ultrafiltration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Blood leak detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Blood loss due to coagulation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Physical data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Materials in contact with water, concentrates and dialysis fluid . . . . . . . . . . . . . . . . Polymers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Metals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Others . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Environmental data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:2 8:2 8:3 8:3 8:3 8:4 8:5 8:6 8:6 8:6 8:7 8:7 8:8 8:11 8:11 8:12 8:12 8:14 8:15 8:15 8:16 8:16 8:16 8:16 8:17 8:17 8:17 8:18 8:18 8:19 8:19 8:19 8:19 8:20 8:20 HCEN9281 Revision 10.2012 Transportation and storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Energy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Electromagnetic environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:20 8:20 8:21 8:25 9. Electrical safety inspection General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Visual inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PET - Protective Earth Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Test equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . for AK 95® / AK 95® S dialysis machines . . . . . . . . . . . . . . . . . . . . . . . . . . for AK 96® dialysis machine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . for AK 200™ / AK 200™ ULTRA / AK 200™ S / AK 200™ ULTRA S dialysis machines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ELT / PLT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Test equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . General conditions for ELT / PLT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ELT - Earth Leakage Current Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PLT - Patient Leakage Current Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Record of Electrical Safety Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9:2 9:4 9:5 9:5 9:5 9:6 9:7 9:8 9:8 9:8 9:9 9:10 9:12 10.Wiring diagram 11.Calibration manual General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:2 Calibration, Fluid Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:3 Technical Facilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:3 A/D Converter FM (CPU Q), FM 21 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:4 A/D Converter FM (CPU F;1), FM 22 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:5 A/D Converter FM (CPU F;2), FM 23 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:6 Temperature FM CPU Board calibration, FM 0 . . . . . . . . . . . . . . . . . . . . . . . 11:7 Degassing Transducer calibration, FM 7 . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:8 Flow Output Pressure Transducer calibration, FM 8 . . . . . . . . . . . . . . . . . . .11:10 Flow Input Pressure Transducer calibration, FM 9 . . . . . . . . . . . . . . . . . . . .11:12 High Pressure Guard Transducer calibration, FM 10 . . . . . . . . . . . . . . . . . . .11:14 Dialysis Fluid Pressure Transducer (PD) calibration, FM 11 . . . . . . . . . . . . .11:16 Safety Guard Pressure Transducer calibration, FM 12 . . . . . . . . . . . . . . . . . .11:18 pH-sensor calibration, FM 13 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11:20 Blood Leakage Detector calibration, FM 24 . . . . . . . . . . . . . . . . . . . . . . . . .11:23 Internal pressure regulator calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11:24 Inlet pressure regulator adjustment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11:25 Conductivity Transducer calibration, FM 20 - with liquid concentrate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11:26 Conductivity Transducer calibration, FM 20 - with SelectCart cartridge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11:28 BiCart SelectⓇ - Level detector calibration . . . . . . . . . . . . . . . . . . . . . . . . . .11:30 BiCart SelectⓇ - control and protective pump calibration . . . . . . . . . . . . . . .11:33 Calibration of Flow Restrictor Node (FRN) main flow supervision . . . . . . . .11:37 Automatic UF calibration/Supervision flow meter calibration . . . . . . . . . . . .11:41 Calibration, Blood Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11:45 HCEN9281 Revision 10.2012 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11:45 A/D Converter BM (CPU P), BM 4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11:45 Venous Pressure Transducer calibration, BM 3 . . . . . . . . . . . . . . . . . . . . . . .11:46 Arterial Pressure Transducer calibration, BM 2 . . . . . . . . . . . . . . . . . . . . . . .11:48 System Pressure Transducer calibration, BM 1 . . . . . . . . . . . . . . . . . . . . . . .11:50 Level Detector calibration (Air detector), BM 5 . . . . . . . . . . . . . . . . . . . . . .11:52 Priming Detector calibration, BM 6 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11:54 Blood Volume Sensor - BVS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11:55 Temperature BM CPU Board calibration, BM 0 . . . . . . . . . . . . . . . . . . . . . .11:55 Occlusion adjustment, blood pump/substitution flow pump . . . . . . . . . . . . . .11:56 BPM test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11:57 Logging after calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11:61 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11:61 Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11:61 Logging values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11:61 12.FM flow diagrams HCEN9281 Revision 10.2012 Chapter 1 General information About this manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Valid revision of AK 200™ S / AK 200™ ULTRA S - Service Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Complaint . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Disclaimer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Competence of Service Engineers . . . . . . . . . . . . . . . . . . . . . . . . . Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Technical support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Waste disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . List of symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . HCEN12395 Revision 10.2012 General information 1:2 1:3 1:4 1:4 1:4 1:5 1:5 1:5 1:6 1:6 1:7 1:1 About this manual This service manual provides the information needed to install the AK 200 S / AK 200 ULTRA S dialysis machine, to carry out maintenance, component replacements and calibrations. It is a guidance how to identify and repair faults that may occur. This service manual also provides a technical description of the functionality of the AK 200 S / AK 200 ULTRA S dialysis machine, including technical data. Questions or comments about this publication can be directed to your local representative or to the manufacturer. 1:2 General information HCEN12395 Revision 10.2012 Valid revision of AK 200™ S / AK 200™ ULTRA S - Service Manual AK 200 S / AK 200 ULTRA S - Service Manual, HCEN9281, Rev. 10.2012, consists of following separate chapters: Denomination Publication no./Revision Ch.1 - General information HCEN12395, Rev. 10.2012 Ch.2 - Installation Guide HCEN9282, Rev. 10.2012 Ch.3 - Maintenance manual HCEN12088, Rev. 10.2012 Ch.4 - Replacements HCEN9284, Rev. 10.2012 Ch.5 - Maintenance support description HCEN9285, Rev. 10.2012 Ch.6 - Technical description HCEN9286, Rev. 10.2012 Ch.7 - Technical data and specifications - AK 200 S dialysis machine HCEN9287, Rev. 10.2012 Ch.8 - Technical data and specifications - AK 200 ULTRA S dialysis machine HCEN9297, Rev. 10.2012 Ch.9 - Electrical safety inspections HCEN12190, Rev. 10.2012 Ch.10 - Wiring diagram, BM Ch.10 - Wiring diagram, FM K20595 CO 23309 K20583 CO 23309 Ch.11 - Calibration manual HCEN12089, Rev. 10.2012 Ch.12 - FM flow diagrams, AK 200 S dialysis machine Ch.12 - FM flow diagrams, AK 200 S UFD dialysis machine Ch.12 - FM flow diagrams, AK 200 ULTRA S dialysis machine HCEN10398 Rev. 02.2010 HCEN10395 Rev. 02.2010 HCEN10399 Rev. 02.2010 Note • This Service Manual is intended to be used for both AK 200 S and AK 200 ULTRA S dialysis machines. • AK 200 ULTRA S Service manual, HCEN9291, will therefore be replaced by this manual. Note HCEN12395 Revision 10.2012 General information 1:3 Installation Installation of the machine should be done in accordance with the recommended procedures in the AK 200 S / AK 200 ULTRA S Installation guide, HCEN9282. When installing a new monitor please ensure proper reporting in Gambro’s global electronical service reporting system whether there are any deviations or not. This is important information and it will assist us to improve the product for you. The initial installation and start up procedure of AK 200 S / AK 200 ULTRA S dialysis machine, may only be performed by Gambro Technical Service organization or a person authorized by Gambro, fulfilling the specified qualifications stated in the section Competence of Service Engineers, (page 1:5). Complaint If a complaint is raised it shall be communicated to the relevant Gambro Sales Company. In order for the Sales Company to be able to determine the relevance of a complaint, it is of vital importance that the deviation is communicated to them as comprehensive as the issue requires. Complaints are important information and it will assist Gambro to improve the product for you. The Complaint system is not valid for products, components or printed circuit boards that isn't in its original delivered condition. Disclaimer The manufacturer accepts responsibility for the safety, reliability, and performance of this equipment only if installation, operational procedures, maintenance, calibrations, and repairs are carried out by appropriately trained and suitable qualified people; if all equipment modifications are authorized in writing by the manufacturer and carried out by appropriately trained and suitable qualified people; if the electrical installation of the relevant room complies with all applicable local electrical codes and, if applicable, IEC requirements; and if the equipment is used in accordance with the published AK 200 S / AK 200 ULTRA S - Operator’s Manual. 1:4 General information HCEN12395 Revision 10.2012 Maintenance To ensure proper operation of the AK 200 S / AK 200 ULTRA S dialysis machine, a qualified service technician must perform a complete series of maintenance procedures at regular intervals. The maintenance and calibration information that you need to use is provided in this Service Manual, refer to chapters Maintenance Manual and Calibrations. It is mandatory to perform at least a preventive maintenance every second year. A yearly maintenance is recommended. The rate of preventive maintenance might be different due to variations of the operating environment. Competence of Service Engineers There is a certain minimum level of competence required for Service Engineers who are to maintain and repair Gambro products, summarized as follows. A Service Engineer is considered suitable qualified if he/she has: 1. Attended AK 200 S / AK 200 ULTRA S technical service course and has been given a certificate stating that the technician has passed the course. 2. Access to the recommended test equipment and special tools detailed in this Service Manual. 3. Access to the recommended spare parts, refer to AK 200 S / AK 200 ULTRA S - Spare parts List, HCEN9288. 4. Access to and understanding of the AK 200 S / AK 200 ULTRA S Operator's Manual. In general, this policy implies that training will be carried out by Gambro Lundia AB, while local markets are responsible for their own service organization. Repair Parts which are sent for repair shall be sent to the following address: Gambro Lundia AB Repair Shop Magistratsvägen 16 SE-226 34 Lund Sweden HCEN12395 Revision 10.2012 General information 1:5 Technical support For technical support please contact your local Gambro Service representative. Waste disposal For the purpose of protecting the environment the AK 200 S / AK 200 ULTRA S dialysis machine must not be disposed with general domestic waste, but shall be separately collected for dismantling and recovery. Where applicable national regulations shall be applied. Consult your relevant Gambro Sales Company for information. 1:6 General information HCEN12395 Revision 10.2012 List of symbols Note • All symbols in this list may not be represented on this product. Symbol Note Description Alternating current. Protective earth (ground). Warning, consult accompanying documents. This symbol indicates that consultation of the accompanying documents prior to equipment operation is critical to the safe operation of the device. The colours are blue and white. Note: This symbol is a complement to the warning triangle symbol. Off (power, disconnection from the mains). On (power, connection to the mains). Type B, applied part (the extracorporeal circuit and the dialysis fluid circuit). Handle with care. HCEN12395 Revision 10.2012 General information 1:7 Symbol Description This way up. Keep dry. Input /Output. Manufacturer. The year of manufacturing may be included in the symbol expressed as four digits. The Manufacturer symbol can also look like this. Heater power supply outlet. Prohibited behaviour. Equipotentiality. Separate collection for electrical and electronic equipment. Recyclable/renewable symbol Corrugated Cardboard. According to GB 18455–2001. 1:8 General information HCEN12395 Revision 10.2012 Symbol Description This symbol indicates that the AK 200 S / AK 200 ULTRA S dialysis machine contains toxic or hazardous substances or elements according to SJ/T 11363–2006. The figure 25 indicates the corresponding environmental protection use period of the AK 200 S / AK 200 ULTRA S dialysis machine. The AK 200 S / AK 200 ULTRA S dialysis machine is protected against dripping water. Catalogue number. Serial number. Humidity limitation. Upper and lower limit is expressed with numeric values in %. Atmospheric pressure limitation. Upper and lower limit is expressed with numeric values in kPa. Temperature limitation. Upper and lower limit is expressed with numeric values in degree Celsius or Fahrenheit. The maximum stacking load permitted on the transport package. HCEN12395 Revision 10.2012 General information 1:9 Symbol Description Do not stack. Electrostatic sensitive device. 1:10 General information HCEN12395 Revision 10.2012 Chapter 2 Installation Guide Contents Before installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Qualification requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Tools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Manufacturer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Unpacking and inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Environment and Physical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Operating Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Transport and Storage Environment . . . . . . . . . . . . . . . . . . . . . . . . Physical data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Mains Voltage and Power Consumption . . . . . . . . . . . . . . . . . . . . . . . Power supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Service Outlets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Line Fuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Mains Water Supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Drain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 V Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Back-up Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Assembling the Monitor Stand . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . MS 200 - Adjustable height: five fixed positions . . . . . . . . . . . . . . MS 200 - Adjusted for installation of WRO 300 / WRO 300 H . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . MS 202 - Adjustable height: continuous variable . . . . . . . . . . . . . . Positioning the dialysis machine on the stand . . . . . . . . . . . . . . . . . . . Installation instructions for AK 200™ S dialysis machine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ................................................... Installation instructions for AK 200™ ULTRA S dialysis machine . . . . . . . . . . . . . . . . . . . . . . . . ................................................... Initial start-up procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . First check: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Start-up procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Service reporting - installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Checklist - Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . HCEN9282 Revision 10.2012 Installation Guide 2:2 2:2 2:2 2:2 2:3 2:4 2:4 2:4 2:5 2:6 2:6 2:6 2:6 2:7 2:8 2:9 2:9 2:9 2:11 2:11 2:12 2:16 2:21 2:26 2:28 2:28 2:34 2:34 2:42 2:42 2:42 2:44 2:45 2:1 Before installation Qualification requirements The initial installation and start-up procedure of the AK 200 S / AK 200 ULTRA S dialysis machine, may only be performed by Gambro Technical Service organization or a person authorized by Gambro, fulfilling the specified qualifications in AK 200 S / AK 200 ULTRA S - Service manual, Chapter 1 Competence of Service Engineers. Tools Recommended tools needed for installation of AK 200 S / AK 200 ULTRA S dialysis machine: • Phillips screwdrivers: • PH 2, length 100 mm • PH 2, length 250 mm • Flat screwdriver: • 1 x 5.5 length 175 mm • Hexagon socket wrench (e.g. flex headed spanners HEX, Metric) • 7 mm • 13 mm • 17 mm • Set of hexagon head keys • Cutting pliers • Tube cutter, e.g. 113500084 Manufacturer Gambro Lundia AB Box 10101 Magistratsvägen 16 SE-220 10 LUND Sweden Phone +46 46 169000 www.gambro.com 2:2 Installation Guide HCEN9282 Revision 10.2012 Unpacking and inspection HCEN9282 Revision 10.2012 • Check that the packaging material is not damaged. If the outer packaging is damaged, lodge a complaint with the transporter before unpacking the equipment. • All packaging material should be disposed in accordance to local regulations. • Ensure that the specified equipment has been delivered. Do the packages contain the specified monitor and options? Are there any units/ components missing? If in doubt, please contact your Gambro Service representative. • Ensure that the voltage specified on the voltage tag matches the mains voltage. If in doubt, please contact your Gambro Service representative. • Check the equipment for any damages. If the equipment is in any way damaged, proper operation cannot be guaranteed. Please contact your Gambro Service representative. Installation Guide 2:3 Environment and Physical Data The AK 200 S / AK 200 ULTRA S dialysis machine can be installed in most environments provided that certain conditions regarding temperature, relative humidity, mains voltage etc. are met. Operating Environment Ambient Temperature range: +18 °C to + 35 °C Relative Humidity range: 15 % - 85 % RH Air Pressure range (atm.pressure): 700 - 1060 hPa Maximum altitude: ≈ 2000 m above sea level Transport and Storage Environment Units being transported or stored must be kept in their original packaging. Units must be handled en route in accordance with special instructions. Units can be transported or stored in the following environment up to 15 weeks: Ambient Temperature range: -20 °C to +70 °C Relative Humidity range: 10 % - 96 % RH Air Pressure range (atm.pressure): 500 - 1060 hPa Note • During transportation and storage the equipment has to be kept in its original packing. If transportation or storage time is more than 15 weeks, the environmental data relating to the operation has to be followed. The maximum ambient temperature for transportation and storage in 96% Relative humidity is +40 °C. If condensation occur when moving the equipment between locations with different temperatures and high relative humidity (e.g. outdoor and indoor locations), the inside of the equipment shall be allowed to dry before switching on the equipment. Note 2:4 Installation Guide HCEN9282 Revision 10.2012 Physical data Depth Width Total Height Floor Area Weight Blood Monitor Weight Fluid Monitor Weight Stand Total Weight Infusion Stand Height Transportation HCEN9282 Revision 10.2012 Approx. 610 mm Approx. 570 mm Adjustable heights 1175 - 1340 mm Five position stand 1152 - 1382 mm 573 x 753 mm Approx. 17 kg Approx. 40 kg Approx. 24 to 31 kg Approx. 81 to 88 kg 1300 to 2150 mm Max. load 10 kg One man installation Fitting into a normal Estate car Installation Guide 2:5 Mains Voltage and Power Consumption The AK 200 S / AK 200 ULTRA S dialysis machine must be plugged into a grounded power socket, not more than 3.0 metres distant. Note • The 115 V-version require two grounded power sockets within 3.0 metres. Note Power supply Mains Voltage Frequency Power Consumption Mains cable: Mains cable connector: Mains cable plug: Earth Leakage Current Patient Leakage Current Fuses 115 or 230 V AC (±10%) 50 or 60 Hz (±5 Hz) Max. 2250 W at 230 V Max. 1650 W at 115 V 3 conductor cable, Length max. 3 m rating 250 V 10 A, 13 -16A Certified to IEC 60320/C19 Plug with protective earth, 250 V AC / 13 -16 A, or Hospital grade plug with protective earth, 125 V AC / 15 A max 500 μA max 100 μA 2 x T 10 A All leakage currents are specified without external equipment connected to the machine. Service Outlets One extra grounded power socket should be available close to the dialysis machine for troubleshooting (PC-logging) and maintenance purposes. Line Fuses Never overload the line fuses and do not supply too many systems via a single line fuse. 2:6 Installation Guide HCEN9282 Revision 10.2012 Mains Water Supply Inlet Water Quality Inlet water quality must comply with local regulations and if no such regulation is available follow ISO 13959. Level for conductivity shall not exceed 0.1 mS/cm. It is possible to use water with higher conductivity if it consists mainly of sodium salts. This may however affect the accuracy of the fluid composition. Refer to AK 200 S and AK 200 ULTRA S Operator’s manuals for more details regarding inlet water requirements. The machine is also prepared for using central water supply for distribution of chemical disinfectant (central chemical disinfection). Inlet Water Pressure to regulator to machine 120 to 800 kPa 85 to 120 kPa Note! If a high frequent noise appears from the pressure regulator, do a small adjustment of it up or down. (85 - 120 kPa) Inlet Water Temperature Treatment Disinfection +5 to +30 °C +5 to +90 °C Water Supply Flow Rate for AK 200 S dialysis machine: Treatment 300 to 750 ml/min Disinfection 0 to 1150 ml/min Water Supply Flow Rate for AK 200 ULTRA S dialysis machine: Treatment 450 to 850 ml/min Disinfection 0 to 900 ml/min HCEN9282 Revision 10.2012 Installation Guide 2:7 Drain Drain (length of tube) Drain capacity Drain outlet Maximum 5 m Minimum 1.0 l/min Maximum 1.2 m above floor Note • Local ordinances may require the use of special measures to protect against the possibility of back-siphonage from dialysis equipment into the water supply. An air gap to atmospheric pressure must always be arranged at the tube outlet. The drain tube should not exceed 5 metres in length. Note 2:8 Installation Guide HCEN9282 Revision 10.2012 Batteries 9 V Battery The rechargeable 9 V battery, mounted inside the blood monitor, is used for the buzzer alarm during main's power failure. The battery is not connected at delivery. Note • This battery must be connected during the installation. Refer to page 2:30 for AK 200 S dialysis machine and page 2:36 for AK 200 ULTRA S dialysis machine. Note A discharged battery will be charged with maximum 12 mA and it must be charged for at least 50 hours to get completely charged. An fully charged battery will receive a maintaining current of approximately 1.5 mA. AK 200 S / AK 200 ULTRA S dialysis machine charges the battery as long as the power supply is switched on, i.e. AK 200 S / AK 200 ULTRA S dialysis machine itself does not need to be switched on. The battery is tested during every functional check to ensure that the capacity is enough in the battery, otherwise an attention will be given: A reminder to change or recharge the battery, must be confirmed in order to disappear. If the attention is confirmed without change or recharge of the battery, note that there is no battery back-up in case of a power failure during treatment. This means that the machine will not be able to alarm or restart in case of a power failure. WARNING Jumper J11 on the BM CPU board must be mounted for the rechargeable battery. If use of an alkaline non-rechargeable battery, jumper J11 must be removed, if not, the battery will be damaged. WARNING Back-up Battery Both lead acid batteries must be changed at the same time and only batteries approved or supplied by Gambro Lundia AB may be used. Changed batteries must be recycled or disposed of properly. Note • This battery must be connected during installation. Follow the assembling instructions for the monitor stand in this chapter. Note HCEN9282 Revision 10.2012 Installation Guide 2:9 The installation and replacement of the back-up battery on the monitor stand must be done according to this electrical diagram. Fuse: T15 A Running time: 15 minutes The charge indicator on the power supply is lit when the AK 200 S / AK 200 ULTRA S dialysis machine is equipped with the back-up battery. The machine must be connected to mains voltage and the mains switch must be on. In a mains failure situation the following attention will be given. Before the battery is empty the following attention will be given. 2:10 Installation Guide HCEN9282 Revision 10.2012 Assembling the Monitor Stand General The monitor stand MS 200 or MS 202 is partly preassembled at delivery. The items to be mounted during installation are: • Lower frame, cover, pillar and upper frame • Battery back-up kit and transformer • Earth connections • Lift control kit • Remote control cable • Infusion stand holders • Filter holders Here follows 3 separate instructions for assembling: HCEN9282 Revision 10.2012 • MS 200 - Adjustable height: five fixed positions • MS 200 - Adjusted for installation of WRO 300 / WRO 300 H • MS 202 - Adjustable height: continuous variable Installation Guide 2:11 MS 200 - Adjustable height: five fixed positions Step 1 1. Place the lower frame of the stand upside-down. 2. Attach the grounding sign beside the earth screw. 3. Assemble the earth cable to the earth screw. 4. Thread the earth cable and the battery cable through the cable entry of the lower frame. Note • This can also be done after the lower frame has been fastened, Step 4, Item 1. Note Step 2 1. Adjust the height of the MS 200. Select the desired position by using the height adjustment screws. MS 200 can be adjusted in five different positions: total height including the AK monitor is 1152 to 1382 mm. 2. Turn the pillar upside-down. 3. Put a thin string silicone on the lower edge of the pillar. Remove all unwanted silicone with a cloth. 2:12 Installation Guide HCEN9282 Revision 10.2012 Step 3 1. Place the lower frame (cover included) on the pillar. Note • Be careful to match the parts exactly to get the correct passing at once (due to the silicone). • Be careful not to damage the earth cable and the battery cable when placing the parts together. Note Step 4 1. Fasten the lower frame (cover included) to the pillar with four hex-head screws (100382030), with a hexagon socket wrench. 2. Assemble the holder for the infusion pole with two screws (100388812). 3. Assemble the connector with two screws (100370410). Note • Before mounting the connector, remove two pins. Note HCEN9282 Revision 10.2012 Installation Guide 2:13 Step 5 1. Assemble the battery back-up kit (K18652001) to the lower frame of the stand with two screws (100388410). 2. Connect the battery cable to the battery back-up. 3. Strap the battery cable to the bar. Step 6 1. Attach the grounding sign beside the earth screw. 2. Assemble the earth cable to the earth screw. 3. Separate the rubber casing on the battery cable (5 cm) and put it in the opening of the upper edge. 4. Insert the sealing grommet in the opening of the short side upper edge. (It is used for the power supply cord to the electrically adjustable stand, MS 202) 2:14 Installation Guide HCEN9282 Revision 10.2012 Step 7 1. Fasten the upper frame to the pillar with four screws (100389903). 2. Fasten the bracket for the dialysis fluid filter holder and Water filter holder. Use four screws (100388510). Step 8 The filter holder to the right is used for dialysis fluid filters. The left filter holder is used for Water filters (AK 200 ULTRA S dialysis machine only). 1. Fasten the filter holder to the right with three screws (100378530). 2. AK 200 ULTRA S dialysis machine only: Fasten the left filter holder with three screws (100378530). HCEN9282 Revision 10.2012 Installation Guide 2:15 MS 200 - Adjusted for installation of WRO 300 / WRO 300 H Step 1 1. Place the lower frame of the stand upside-down. 2. Attach the grounding sign beside the earth screw. 3. Assemble the earth cable to the earth screw. 4. Thread the earth cable and the battery cable through the cable entry of the lower frame. 5. Loosen the four screws and remove the battery holder, according to the illustration. Step 2 1. Adjust the height of the MS 200. When using AK 200 S dialysis machine together with WRO 300 / WRO 300 H it is recommended to use the second highest position to avoid the tubes being squeezed. Select the desired position by using the height adjustment screws. 2. Turn the pillar upside-down. 3. Put a thin string silicone on the lower edge of the pillar. Remove all unwanted silicone with a cloth. 2:16 Installation Guide HCEN9282 Revision 10.2012 Step 3 1. Place the lower frame (cover included) on the pillar. Note • Be careful to match the parts exactly to get the correct passing at once (due to the silicone). • Be careful not to damage the earth cable and the battery cable when placing the parts together. Note Step 4 1. Fasten the lower frame (cover included) to the pillar with four hex-head screws (100382030), with a hexagon socket wrench. 2. Assemble the holder for the infusion pole with two screws (100388812). 3. Assemble the connector with two screws (100370410). Note • Before mounting the connector, remove two pins. Note HCEN9282 Revision 10.2012 Installation Guide 2:17 Step 5 1. Move the back-up batteries (1a)2 from the holder included in the battery back-up kit (K18652001) to the battery holder adjusted for WRO 300 / WRO 300 H (1b) according to the illustration. Note • Do not disconnect the cables from the batteries, fuse holder or the contact. Note 2. Mount the contact for the battery cable and the fuse holder to the battery holder. 3. Fasten the printed circuit board to the battery holder with the adhesive quick lock. Note • The electrical installation of the back-up batteries must remain according to the diagram on the battery holder. Note Step 6 1. Assemble the complete battery holder (including batteries, cables, fuse holder, contact for the battery cable and printed circuit board) to the lower frame of the stand with four screws (100388510). 2. Connect the battery cable to the battery back-up. 3. Strap the battery cable to the bar. 1 2:18 including cables, fuse holder, contact for the battery cable and printed circuit board Installation Guide HCEN9282 Revision 10.2012 Step 7 1. Attach the grounding sign beside the earth screw. 2. Assemble the earth cable to the earth screw. 3. Separate the rubber casing on the battery cable (5 cm) and put it in the opening of the upper edge. 4. Insert the sealing grommet in the opening of the short side upper edge. (It is used for the power supply cord to the electrically adjustable stand, MS 202) Step 8 1. Fasten the upper frame to the pillar with four screws (100389903). 2. Fasten the bracket for the dialysis fluid filter holder and Water filter holder. Use four screws (100388510) and four washers 100392905. HCEN9282 Revision 10.2012 Installation Guide 2:19 Step 9 The filter holder to the right is used for dialysis fluid filters. The left filter holder is used for Water filters (AK 200 ULTRA S dialysis machine only). 1. Fasten the filter holder to the right with three screws (100378530). 2. AK 200 ULTRA S dialysis machine only: Fasten the left filter holder with three screws (100378530). Step 10 1. Place the WRO 300 / WRO 300 H monitor on the bottom of the stand according to the illustration. 2. Mount the tilt protection bar (K23902A) in the two holes according to the illustration. Note • Use the adaption kit (K2395501) to connect the WRO 300 / WRO 300 H monitor to the AK 200 S / AK 200 ULTRA S dialysis machine. Assembling instruction is included in the kit. Note 2:20 Installation Guide HCEN9282 Revision 10.2012 MS 202 - Adjustable height: continuous variable Step 1 1. Place the lower frame of the stand upside-down. 2. Insert and rotate the lift control kit by lifting the lower frame. 3. Attach the grounding sign beside the earth screw. 4. Assemble the earth cable to the earth screw. 5. Thread the earth cable and the battery cable through the cable entry of the lower frame. Note • This can also be done after the lower frame has been fastened (Step 4, Item 1). Note Step 2 1. Turn the pillar upside-down. 2. Place the contact in the carrier. 3. Put a thin string silicone on the lower edge of the pillar. Remove all unwanted silicone with a cloth. Note • MS 202 is variable adjustable in height. Total height including the AK-monitor is 1175 to 1340 mm. Note HCEN9282 Revision 10.2012 Installation Guide 2:21 Step 3 1. Place the lower frame (cover included) on the pillar. Note • Be careful to match the parts exactly to get the correct passing at once (due to the silicone). • Be careful not to damage the earth cable and the battery cable when placing the parts together. Note Step 4 1. Fasten the lower frame (cover included) to the pillar with four hex-head screws (100382030), with a hexagon socket wrench. 2. Connect the motor cable to the lift control kit. 3. Connect the power cable from the lift control kit to the battery back-up. 4. Connect the remote control cable to the lift control kit. 5. Assemble screw (100388045) and locking nut (100316260). Note • Adjust the stand until the screw can be inserted. Note 2:22 Installation Guide HCEN9282 Revision 10.2012 6. Assemble the connector with two screws (100370410). Note • Before mounting the connector, remove two pins. Note 7. Assemble the holder for the infusion pole with two screws (100388812). 8. Raise the pillar 20 cm. 9. Remove the remote control cable from the lift control kit. 10. Remove the power cable from the battery back-up. Step 5 1. Assemble the battery back-up kit (K18652001) to the lower frame of the stand with two screws (100388410). 2. Connect the battery cable to the battery back-up and strap the cable to the bar. 3. Strap the power cable and the two battery cables to the bar. 4. Strap the motor cable and the power cable. HCEN9282 Revision 10.2012 Installation Guide 2:23 Step 6 1. Lower the stand by removing the four screws (100389903). Note • Hold the stand when removing the last screw. Note 2. Attach the grounding sign beside the earth screw. 3. Assemble the earth cable to the earth screw. 4. Separate the rubber casing on the battery cable (5 cm) and put it in the opening of the upper edge. 5. Lead the remote control cable through the stand and through the bottom hole. WARNING Beware of the movement/rotation and the sharp edges of the pillar. WARNING 6. Attach the remote control cable to the lift control kit. 7. Cut the sealing grommet. Use ethanol to simplify the assembly. 8. Insert the sealing grommet in the opening of the short side upper edge and stretch the cable according to the maximum height of the stand. 9. Lower the pillar with the remote control. 2:24 Installation Guide HCEN9282 Revision 10.2012 Step 7 1. Fasten the upper frame to the pillar with four screws (100389903). 2. Raise the stand 20 cm with the remote control. 3. Fasten the bracket for the dialysis fluid filter holder and Water filter holder. Use four screws (100388510). Step 8 The filter holder to the right is used for dialysis fluid filters. The left filter holder is used for Water filters (AK 200 ULTRA S dialysis machine only). 1. Fasten the filter holder to the right with three screws (100378530). 2. AK 200 ULTRA S dialysis machine only: Fasten the left filter holder with three screws (100378530). HCEN9282 Revision 10.2012 Installation Guide 2:25 Positioning the dialysis machine on the stand 2:26 Installation Guide HCEN9282 Revision 10.2012 Figure 2:35 Positioning: machine - stand 1. Place the dialysis machine on the stand. • Observe that the plugged tubes from the fluid monitor at the bottom of the machine fit into the holes in the stand. 2. Fix the fluid monitor with four screws, 100388512. 3. Connect the earth cable from the fluid monitor and mount the washers and nut. See figure above. 4. Put the fluid protective tray on the top of the machine. HCEN9282 Revision 10.2012 Installation Guide 2:27 Installation instructions for AK 200™ S dialysis machine Step 1 Dialysis fluid filter holder (Only for AK 200 S dialysis machines with UFD-kit) 1. Attach angled connectors to the tubes coming from the fluid monitor. Attach angled connectors to the dialysis fluid filter holder. Connect tube 132, 133 and 134 from the dialysis fluid filter holder to the tubes coming from the fluid monitor, according to these figures. 2. Strap the tubes. 3. Insert a new ultrafilter into the dialysis fluid filter holder according to instructions in the AK 200 S Operator's Manual. Step 2 pH-sensor 1. If a pH-sensor is to be installed, remove the pH dummy and insert the pH-sensor. Note pH-sensor calibration • If the machine is equipped with the pH-sensor option, this must be calibrated during installation. Ref. to AK 200 S/AK 200 ULTRA S Service Manual, chapter Calibration manual. • It is important that the pH-sensor is calibrated when the dialysis machine is installed, since the delivered pH meter has not been calibrated with the actual machine. Note 2:28 Installation Guide HCEN9282 Revision 10.2012 Step 3 a Dialyzer connector set, blue 1. Connect a sample port for 6 mm tubes (K20219002) to the dialyzer connector set (blue) with clamps (Ø 12 mm). 2. Attach the nut on the tube. 3. Attach an insert on the tube. 4. Fasten it to the machine according to the figure. 5. Fasten the blue safety coupling to the right coupling on the machine. Step 3 b Dialyzer connector set, red 1. Attach the nut on the tube. 2. Attach an insert on the tube. 3. Fasten it to the machine according to the figure. 4. Fasten the red safety coupling to the left coupling on the machine. Step 4 Pressure regulator 1. Assemble the pressure regulator (100313255) to the upper holder for the infusion pole. 2. Fasten the upper holder for the infusion pole with two screws (100389903). HCEN9282 Revision 10.2012 Installation Guide 2:29 Step 5 Infusion stand and service handle 1. Fasten the infusion stand and the mast top with one screw (100382816). 2. Fasten the service handle. Step 6 BM - 9 V battery WARNING Jumper J11 on the BM CPU board must be mounted for the rechargeable battery. If use of an alkaline non-rechargeable battery, jumper J11 must be removed, if not, the battery will be damaged. WARNING The rechargeable 9 V battery inside the Blood monitor must be connected during the installation. 1. Connect the battery cable to connector P51 on the BM CPU board. 2:30 Installation Guide HCEN9282 Revision 10.2012 Step 7 Connection of hoses Connect following hoses according to the figure: 1. Connect the inlet water hose (no. 1) from the pressure regulator to the water supply. 2. Connect hose no. 2 from the pressure regulator to the non-return valve. 3. Connect hose no. 3 from the non-return valve to the inlet water nipple. 4. Connect hose no. 4 from the drain nipple to the drain. Item Denomination Order no. Clamp 1. Reinforced PVC tube 100312213 100334217 2. Reinforced silicon tube 8 x 3.5 mm 100312094 100334217 3. Reinforced silicon tube 8 x 3.5 mm 100312094 100334217 4. Reinforced PVC tube 100312213 100334217 HCEN9282 Revision 10.2012 Installation Guide 2:31 Step 8 Power supply WARNING The mains power cable from the AK 200 S dialysis machine must be plugged into a socket with Protective Earth (PE) to avoid risk of electrical shock. WARNING 1. Connect the machine to a grounded power socket, not more than 3.0 metres in distance. Note • The 115 V-version require two grounded power sockets within 3.0 metres. • The mains power should be be supplied by a unique fuse group from the main central. Ensure that other equipment connected to the same central does not load the voltage supply in a manner that decreases the supplied voltage to levels outside the limits. Note 2:32 Installation Guide HCEN9282 Revision 10.2012 Step 9 Connection of external equipment Following connections are located at the rear of the machine: • Yellow (P79): Relay interface • Black (P63): PC-serial connection and program load interface • Blue (P76): UF-cell calibration interface, WRO 300 / WRO 300 H • Ethernet (P64): Ethernet PC-connection and program load interface. Intended for Exalis computer system. HCEN9282 Revision 10.2012 Installation Guide 2:33 Installation instructions for AK 200™ ULTRA S dialysis machine Step 1 Dialysis fluid filter holder 1. Attach angled connectors to the tubes coming from the fluid monitor. Attach angled connectors to the dialysis fluid filter holder. Connect tube 132, 133 and 134 from the dialysis fluid filter holder to the tubes coming from the fluid monitor, according to these figures. 2. Insert a new ultrafilter into the dialysis fluid filter holder according to instructions in the AK 200 ULTRA S Operator’s Manual. 3. Insert a new ultrafilter into the dialysis fluid filter holder according to instructions in the AK 200 ULTRA S Operator’s Manual. Step 2 pH-sensor 1. If a pH-sensor is to be installed, remove the pH dummy and insert the pH-sensor. Note pH-sensor calibration • If the machine is equipped with the pH-sensor option, this must be calibrated during installation. Ref. to AK 200 S/AK 200 ULTRA S Service Manual, chapter Calibration manual. • It is important that the pH-sensor is calibrated when the dialysis machine is installed, since the delivered pH meter has not been calibrated with the actual machine. Note 2:34 Installation Guide HCEN9282 Revision 10.2012 Step 3 a Dialyzer connector set, blue 1. Connect a sample port for 6 mm tubes (K20219002) to the dialyzer connector set (blue) with clamps (Ø 12 mm). 2. Attach the nut on the tube. 3. Attach an insert on the tube. 4. Fasten it to the machine according to the figure. 5. Fasten the blue safety coupling to the right coupling on the machine. Step 3 b Dialyzer connector set, red 1. Attach the nut on the tube. 2. Attach an insert on the tube. 3. Fasten it to the machine according to the figure. 4. Fasten the red safety coupling to the left coupling on the machine. Step 4 Pressure regulator 1. Assemble the pressure regulator (100313255) to the upper holder for the infusion pole. 2. Fasten the upper holder for the infusion pole with two screws (100389903). HCEN9282 Revision 10.2012 Installation Guide 2:35 Step 5 Infusion stand and service handle 1. Fasten the infusion stand and the mast top with one screw (100382816). 2. Fasten the service handle. Step 6 BM - 9 V battery WARNING Jumper J11 on the BM CPU board must be mounted for the rechargeable battery. If use of an alkaline non-rechargeable battery, jumper J11 must be removed, if not, the battery will be damaged. WARNING The rechargeable 9 V battery inside the Blood monitor must be connected during the installation. 1. Connect the battery cable to connector P51 on the BM CPU board. 2:36 Installation Guide HCEN9282 Revision 10.2012 This page is intentionally left blank HCEN9282 Revision 10.2012 Installation Guide 2:37 Step 7 Connection of hoses and Water filter Connect following hoses according to the figure on the next page: 1. Connect the inlet water hose (no. 1) from the pressure regulator to the water supply. 2. Connect hose no. 2 from the pressure regulator to the non-return valve. 3. Connect hose no. 3 from the non-return valve to the inlet water nipple. 4. Connect hose no. 4 to the Water filter from the upper left nipple. 5. Connect hose no. 5 from the Water filter to the upper right nipple. 6. Connect hose no. 6 from the drain port of the Water filter to the drain. 7. Connect hose no. 7 from the drain nipple to the drain. 8. Insert a new ultrafilter into the Water filter holder according to instructions in the AK 200 ULTRA S Operator's Manual. 2:38 Item Denomination Order no. Clamp 1. Reinforced PVC tube 100312213 100334217 2. Reinforced silicon tube 8 x 3.5 mm 100312094 100334217 3. Reinforced silicon tube 8 x 3.5 mm 100312094 100334217 4. Reinforced silicon tube 8 x 3.5 mm 100312094 100334217 5. Reinforced silicon tube 8 x 3.5 mm 100312094 100334217 6. Reinforced PVC tube 100312213 100334217 7. Reinforced PVC tube 100312213 100334217 8. Ultrafilter U 8000 S Installation Guide HCEN9282 Revision 10.2012 HCEN9282 Revision 10.2012 Installation Guide 2:39 Step 8 Power supply WARNING The mains power cable from the AK 200 ULTRA S dialysis machine must be plugged into a socket with Protective Earth (PE) to avoid risk of electrical shock. WARNING 1. Connect the machine to a grounded power socket, not more than 3.0 metres in distant. Note • The 115 V-version require two grounded power sockets within 3.0 metres. • The mains power should be be supplied by a unique fuse group from the main central. Ensure that other equipment connected to the same central does not load the voltage supply in a manner that decreases the supplied voltage to levels outside the limits. Note 2:40 Installation Guide HCEN9282 Revision 10.2012 Step 9 Connection of external equipment Following connections are located at the rear of the machine: • Yellow (P79): Relay interface • Black (P63): PC-serial connection and program load interface • Blue (P76): UF-cell calibration interface, WRO 300 / WRO 300 H • Ethernet (P64): Ethernet PC-connection and program load interface. Intended for Exalis computer system. HCEN9282 Revision 10.2012 Installation Guide 2:41 Initial start-up procedure First check: • That the 9 V battery is installed. • That the mains cable is connected to a grounded power socket, not more than 3.0 metres from the machine. Note • Ensure that the voltage specified on the voltage tag matches the mains voltage. If in doubt, please contact your Gambro Service representative. Note • The main switch on the power supply should always be in ON position, even when the AK 200 S / AK 200 ULTRA S dialysis machine is not in use. This “Stand by” mode is indicated by a lit segment on the TIME display on the Operator's panel. • That the machine is connected to the water supply. • That the drain tube is properly connected to the machine and placed with an air gap between the drain tube and the drain. • That both the red and blue dialysis fluid tubes are connected to the safety bypass unit. • AK 200 S dialysis machine: That the optional U 8000 S filter (Ultrafilter used as dialysis fluid filter) is installed in the dialysis fluid filter holder. • AK 200 ULTRA S dialysis machine: That the U 8000 S filters (Ultrafilter used as water filter and dialysis fluid filter) are installed in the dialysis fluid filter holder and the Water filter holder. Start-up procedure 1. Press the ON/OFF button for 3 seconds. 2. Preset the machine according to the clinics demand. Refer to AK 200 S / AK 200 ULTRA S- Service Manual, chapter: Maintenance support description / Preset mode. 3. pH-sensor calibration: 2:42 Installation Guide HCEN9282 Revision 10.2012 If the AK 200 S / AK 200 ULTRA S dialysis machine is equipped with the pH-sensor option, this must be calibrated during installation. Refer to the AK 200 S / AK 200 ULTRA S Service Manual, chapter Calibration manual, pH sensor calibration. Note • It is important that the pH-sensor is calibrated when the AK 200 S / AK 200 ULTRA S dialysis machine is installed, since the delivered pH-meter has not been calibrated with the actual machine. Note 4. Adjust the inlet pressure regulator according to AK 200 S / AK 200 ULTRA S Service Manual, chapter Calibration manual, Inlet pressure regulator adjustment. 5. To verify full functionality - let the AK 200 S / AK 200 ULTRA S dialysis machine pass Fch. Note • Each time the AK 200 S / AK 200 ULTRA S dialysis machine is started, the automatic functional check, Fch, is carried out. This check requires that the dialysis fluid tubes are connected to the safety bypass unit. The dialysis fluid tubes must remain connected to the safety bypass unit until “Fch” has disappeared from the time display. Note 6. Perform a heat disinfection (or a chemical disinfection) according to the AK 200 S / AK 200 ULTRA S - Operator’s Manual. 7. After the heat disinfection; re-tighten the nuts of the dialyser connector set to the machine. 8. It is recommended to perform a simulated treatment according to instructions in AK 200 S / AK 200 ULTRA S Maintenance Manual, HCEN12088, step 39. WARNING After completing the installation process the composition of the dialysis fluid must be confirmed in laboratory tests, before the AK 200 S / AK 200 ULTRA S dialysis machine is ready for use. WARNING HCEN9282 Revision 10.2012 Installation Guide 2:43 Service reporting - installation When installing a new monitor please ensure proper reporting in Gambro’s global electronical service reporting system whether there are any deviations or not. This is important information and it will assist us to improve the product. 2:44 Installation Guide HCEN9282 Revision 10.2012 Checklist - Installation Machine □ AK 200 S dialysis machine □ AK 200 ULTRA S dialysis machine Serial number FM: ____________________ BM: ____________________ Unpacking and inspection □ Ensure that the packaging material is not damaged. □ Ensure that the specified equipment has been delivered. □ Check that the additional package box contains the specified components. □ Check, by visual inspection, that the machine shows no sign of damage. Environment and Physical Data □ Ensure that the Operating Environment is according to the specifications. Monitor Stand Ensure that the Monitor Stand is assembled correctly according to the instructions for MS 200, MS 200 - WRO 300 / WRO 300 H or MS 202. MS 200 MS 200 - WRO 300 / WRO 300 H MS 202 HCEN9282 Revision 10.2012 Installation Guide 2:45 Positioning the dialysis machine on the stand □ Place the AK 200 S / AK 200 ULTRA S dialysis machine on the stand □ Fix the fluid monitor □ Connect the earth cable □ Ensure that the top tray is placed at the top of the machine Installation of the AK 200™ S / AK 200™ ULTRA S dialysis machine Initial start-up procedure □ Ensure that the recommended start-up procedure is followed Service reporting - installation □ Ensure proper reporting in Gambro’s global electronical service reporting system whether there are any deviations or not. Note! If you have any remarks during installation, please contact your Gambro Service representative. This record is to be signed and filed by the Service Engineer responsible for the initial installation and start-up procedure of this AK 200 S / AK 200 ULTRA S dialysis machine. 2:46 Installation Guide HCEN9282 Revision 10.2012 Chapter 3 Maintenance manual Contents General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Test equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Preventive Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Base-kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . How to exchange the parts included in the Base-kit . . . . . . . . . Actions to carry out after the parts have been exchanged . . . . . Supplementary A-kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . How to exchange the exterior parts included in the A-kit . . . . . Actions to carry out after the parts have been exchanged . . . . . Supplementary B-kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . How to exchange the overhaul parts included in the B-kit . . . . . Actions to carry out after the parts have been exchanged . . . . . Test after defibrillator use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Actions, test after defibrillator use . . . . . . . . . . . . . . . . . . . . . . . . . HCEN12088 Revision 10.2012 Maintenance manual 3:2 3:3 3:4 3:4 3:4 3:5 3:9 3:35 3:35 3:36 3:37 3:39 3:39 3:40 3:42 3:43 3:43 3:1 General To ensure proper operation of the AK 200 S / AK 200 ULTRA S dialysis machine, a qualified service technician must perform a complete series of preventive maintenance procedures at regular intervals. The maintenance and calibration information that you need to use is provided in this manual. The preventive maintenance procedures have been devised to require a minimum of time while ensuring that the machine is maintained in optimum operation condition. Included in the preventive maintenance procedures are checks to verify normal machine operation. Should the machine fail to pass any of these tests, repair or calibration might be needed, then repeat the tests until the specifications are met. It is mandatory to perform at least one preventive maintenance every second year. A yearly maintenance is recommended. The rate of preventive maintenance might be different due to variations of the operating environment. The AK 200 S / AK 200 ULTRA S dialysis machine will perform as designed only if it is used and maintained in accordance with Gambro’s instructions. Any warranties made by Gambro with respect to the AK 200 S / AK 200 ULTRA S dialysis machine are void if the equipment is not used in accordance with the instructions provided. Gambro will not accept responsibility for any damage or injury resulting from improper use or maintenance or unauthorized repair. To fulfil the preventive maintenance procedures for AK 200 S / AK 200 ULTRA S dialysis machine some parts must be exchanged. The necessary parts to be exchanged are available in one Base-kit and two complementary kits: • Base-kit (K40165001) • A-kit (K40166002): Includes exterior parts • B-kit (K40167001): Overhauling service-kit When performing preventive maintenance procedures or calibrations, which require access to the interior of the machine, you must have proper electrostatic safety devices (i.e. wrist grounding straps or grounding mats) in place to prevent damage to electrostatic sensitive components within the machine. During repair of any of the parts in the flow path, special care should be taken and a good hygiene should be kept. Note • After maintenance a disinfection program must be performed before a treatment is performed. Note 3:2 Maintenance manual HCEN12088 Revision 10.2012 Checklists are provided in the Spare Parts Instruction that is included in the maintenance kits. The purpose of these checklists is to record the work done. Test equipment Test equipment needed to perform maintenance. Test equipment Tolerance Manufacturer Conductivity measurement ±0.1 mS/cm MESA, IBP Pressure measurement ±2 mmHg within ±200 mmHg ±1% beyond ±200 mmHg If BPM is installed: ±0.8 mmHg MESA, IBP, Druck Temperature measurement: ±0.2 ºC MESA, IBP Digital Voltmeter ±0.5% Fluke Measuring glass ±5 ml Any Blood leakage calibration cover N/A Gambro K40169001 Gauge pin kit for blood pump rollers (including three different pins) T = 1.1 (Stop pin = 1.1 x 2 x 0.7 = 1.5 mm) T = 1.6 (Stop pin = 1.6 x 2 x 0.7 = 2.2 mm) T = 2.0 (Stop pin = 2.0 x 2 x 0.7 = 2.8 mm) T = wall thickness of the blood tubing Gambro K40158001 Calibration tube kit N/A Gambro K13983002 Drip chamber N/A Gambro N/A Tube for calibration of priming detector N/A Gambro N/A Safety tester According to IEC 60601-1 Rigel, Biotec, Metron, Fluke BPM test equipment (if installed) N/A Gambro K22151001 BPM Cuff (if installed) N/A Gambro 110350 pH buffers (if installed) ±0.07 pH units Any pH 7 – 100810001 pH 9 – 100810002 BVS test tool N/A Gambro K22281001 Magnet for blood pump cover N/A Gambro K19049002 Gambro K40246001 Leakage current access point, PLT box HCEN12088 Revision 10.2012 Maintenance manual Order number 3:3 Preventive Maintenance Base-kit Parts The Base-kit (K40165001) includes all parts necessary to fulfil the mandatory preventive maintenance procedures for AK 200 S / AK 200 ULTRA S dialysis machine. Step Monitor Denomination Part no. 2, 3 Qty BM/FM Air filter K11503001 3 4 AC/DC Air filter K18891001 1 5, 6 FM O-ring for BiCart- and SelectCart cartridge holder, upper and lower. 100319008 4 7 FM O-ring for ultrafilter holders 100319029 4 7 FM Square-ring for ultrafilter holders K14920001 2 8 FM Filter BiCart cartridge holder, upper and lower (50µm) K16538C 2 9 FM Filter SelectCart cartridge holder, lower (50µm) K16538C 1 10 FM Filter after the SelectBag container holder (50µm) K16538C 1 11 FM Filter heating vessel (250µm) K14944001 1 12 FM V-ring heating vessel 100318086 2 13 FM Membrane for internal pressure regulator K40153001 1 14 FM Membrane for non-return valve K17989001 1 15 FM Sample port for 6 mm tube K20219002 1 16 FM Sealing ring (Inlet unit - heating vessel) K07994001 1 16 FM Ring (Inlet unit - heating vessel) K08227001 1 17 FM Sealing for substitution fluid port K18184001 1 18 FM Label K24092001 1 Note • As a complement to the Base-kit, two additional kits are available; A- and B-kit. Note 3:4 Maintenance manual HCEN12088 Revision 10.2012 How to exchange the parts included in the Base-kit 1. First perform a combined heat disinfection program with CleanCart C cartridge or liquid citric acid. Then perform a heat disinfection program in combination with CleanCart A cartridge or a Chemical disinfection program with sodium hypochlorite. Refer to the AK 200 S or AK 200 ULTRA S Operator’s Manual. 2. Change air filters in the Blood Monitor. 3. Change air filter in the Fluid Monitor. 4. Change air filters in the AC/DC unit. 5. Change the upper and lower O-rings in the BiCart cartridge holder. HCEN12088 Revision 10.2012 Maintenance manual 3:5 6. Change the upper and lower O-rings in the SelectCart cartridge holder. 7. Change the O-rings and square-rings in the ultrafilter holders. (Only for AK 200 S with UFD-kit and AK 200 ULTRA S dialysis machines) Note • This information is for step 8 to 10: • To prevent that air is getting trapped inside the particle filters (50 μm), it is important that the particle filters are correct positioned according to this figure. Note 8. Change the upper and lower filters on the BiCart cartridge holder (50 μm). 3:6 Maintenance manual HCEN12088 Revision 10.2012 9. Change the lower filter on the SelectCart cartridge holder (50 μm). 10. Change the particle filter after the SelectBag container holder (50 μm). 11. Change the filter at the heating vessel (250 μm). 12. Change the V-rings in the heating vessel. 13. If ULTRA: Change the membrane for the internal pressure regulator. HCEN12088 Revision 10.2012 Maintenance manual 3:7 14. If ULTRA: Change the membrane for the non-return valve. 15. Change the sample port. 16. Change the sealing ring and the ring on the inlet unit inside the heating vessel. • It is important that the sealing ring is reassembled with its flat side according to this illustration. 17. If ULTRA: Change the sealing for the substitution fluid port on the FM front. 18. Mark month and year for the next scheduled preventive maintenance. Attach the label to the rear cover of the machine. 3:8 Maintenance manual HCEN12088 Revision 10.2012 Actions to carry out after the parts have been exchanged 1. Check that the screws for the blood pump(s) are tightened. 2. Check that the screws for the hose clamps on the water inlet and drain tube are tightened. 3. Check that the wheels are tightened. 4. Check that the screw for the infusion stand is tightened. HCEN12088 Revision 10.2012 Maintenance manual 3:9 5. Perform the Protective Earth Test (PET) according to instructions available in Electrical safety inspection for AK-machines. 6. Check the insulation resistance in BM. Measure between TP 8 (Z0VL) on the BM CPU board and the earth point on the bottom plate. Measure in MΩ, should be > 1 MΩ. The machine must be empty and switched off during measurement. • The BM must be connected to the FM. 7. Check the insulation resistance in FM. Measure between TP 7 (Z0VL) on the Power distribution board and the earth point on the back plate. Measure in MΩ, should be > 1 MΩ. The machine must be empty and switched off during measurement. 8. Erase the error code buffers. Enter service menu > Diagnose > System > Errors > Erase 3:10 Maintenance manual HCEN12088 Revision 10.2012 9. BPM-test Test method • Attach BPM cuff, 110350, tight to the BPM test equipment, K22151001. • Start the AK 200 S / AK 200 ULTRA S dialysis machine with the main switch and the ON/OFF button. • Enter Service mode, Diagnose / BM / Others and BPM BPM sub-tests Following sub-tests are included: • Air leakage test: measures that the equipment is airtight. • Inflation speed test: measures the time to fill the cuff with air. • Static pressure: Check of pressure transducer calibration Each of the tests can be carried out separately but the above order for carrying out the sub-tests is recommended. Check that the results from the sub-tests not exceed following limits: • Air leakage: maximum 18 mmHg / 3 min. • Inflation speed: 2 - 11 s • Static pressure: Maximum deviation from reference to be within ±3 mmHg. 20 ±3 mmHg 150 ±3 mmHg 260 ±3 mmHg HCEN12088 Revision 10.2012 Maintenance manual 3:11 Check of air leakage By entering this test mode the air leakage for the BPM module, cuff hose and cuff will be tested automatically. Before entering the test mode cuff and cuff hose to be connected to the AK 200 S / AK 200 ULTRA S dialysis machine. Cuff to be wrapped tight to the BPM test equipment. BPM test equipment is used to simulate the patient arm circumference. The air leakage is only tested for 90 sec but the value is recalculated for 3 minutes. If the displayed value is above 18 mm Hg / 3 minutes, this indicates that there is a possible air leakage in the system. It is of course also possible to perform this test without the cuff and cuff hose connected but then the test will only check for air leakage within the AK 200 S / AK 200 ULTRA S dialysis machine. In this case replace the cuff and cuff hose by a tube, which is closed. Check of inflation speed By entering this test mode the capacity of the pump within the module will be tested automatically. Before entering the test mode cuff and cuff hose to be connected to the AK 200 S / AK 200 ULTRA S dialysis machine. Cuff to be wrapped tight to the BPM test equipment. If the displayed time is above 11 seconds, this test indicates that the pump is worn-out. Check of pressure transducer calibration and measured pressure By entering this test mode it will be possible to check the actual pressure value of the BPM pressure on the AK 200 S / AK 200 ULTRA S display. Before entering the test mode, pressure transducer calibration tube from kit K13983002 to be connected to the BPM connector on the AK 200 S / AK 200 ULTRA S dialysis machine. No cuff and cuff hose to be connected. Note • The pressure transducer calibration tube kit must be drained before being connected, to make sure that no fluids or particles enters the BPM connector or tubing’s. This might otherwise damage or destroy the sensitive BPM sensors. Note When “Measured pressure” is displayed it is possible to start applying the external reference pressure. 3:12 Maintenance manual HCEN12088 Revision 10.2012 Note • The BPM is equipped with an over pressure protection. It is activated for pressures above 300 mmHg. • The pressure transducer test is to be performed within approx. 2 minutes. Then the pressure is automatically released. Note To check the actual pressure value, external pressure reference instrument to be connected and external pressure of 250, 150, 50 mmHg to be applied. Check deviation from reference pressure instrument for displayed value. HCEN12088 Revision 10.2012 Maintenance manual 3:13 10. Calibrate the Priming detector (BM 6). Equipment needed: Reference tube 10.1. Start the AK 200 S / AK 200 ULTRA S dialysis machine and enter the service menu, Calibr / BM. 10.2. Set the display to: 10.3. Press the Start UF Stop button to enter calibration routine. 10.4. The display shows: 10.5. Insert an empty reference tube in the priming detector. The reference tube shall be from the same type of blood line as used during treatment. 10.6. Press the lit Arrow button 10.7. The calibration is now performed automatically and the calibration factor is written into the EEPROM. 10.8. The calibration result is displayed: 10.9. Press the lit Arrow button to confirm. 3:14 Maintenance manual HCEN12088 Revision 10.2012 11. Calibrate the Level detector (Air detector) (BM 5). Equipment needed: Drip chamber, Pressure meter, Calibration tube set. 11.1. Start the AK 200 S / AK 200 ULTRA S dialysis machine and enter the service menu, Calibr / BM. 11.2. Set the display to: 11.3. Press the Start UF Stop button to enter calibration routine. 11.4. Insert a filled drip chamber. It is recommended that both the water and the drip chamber have a temperature of 37 °C. Make sure that the level detector (Air detector) and drip chamber are dry and clean. The drip chamber shall be from the same type of blood line as used during treatment. 11.5. Apply a pressure of 100 mmHg (± 10 mmHg), to the venous drip chamber. Use the pressure meter as reference. Note • When creating a positive pressure in the venous drip chamber, a more treatment like condition is simulated as the pressure inside the drip chamber becomes approximately the same as the venous pressure during treatment. • The purpose is to get a better contact between the chamber and the air detector head, which results in a higher calibration value. Note 11.6. Wait for 2 minutes and then press the lit Arrow button 11.7. The calibration is now performed automatically and the calibration factor is written into the EEPROM. 11.8. The calibration result is displayed: The value under LEVEL is the new alarm limit, which shall be 50 or higher. The value under TRANSMIT is the transmission level, which is normally 255 but can also be 160, if the air detector is exceptionally good. HCEN12088 Revision 10.2012 Maintenance manual 3:15 12. Measure the voltage between TP 23 and TP 24 on the BM CPU board. (See figure below.) Exchange battery B1 if the value is below 2.6 V. Note! The machine must be switched on when measuring. 3:16 Maintenance manual HCEN12088 Revision 10.2012 13. Control of the blood pump/substitution flow pump occlusion • Check surface on the roller at the pump rotor, if it is damaged exchange the unit. • The roller unit should easily go back to upper end position when it has been pressed down to end position. Exchange unit if it gets stuck in any position. Note • If the pump segment has a different wall thickness, the occlusion of the pump must be adjusted to the correct wall thickness. Note Use the gauge pins (stop/go) available in the kit K40158001. The kit includes following three different gauge pins: T = 1.1 (Stop pin = 1.1x2x0.7 = 1.5mm) T = 1.6 (Stop pin = 1.6x2x0.7 = 2.2mm) T = 2.0 (Stop pin = 2.0x2x0.7 = 2.8mm) T = wall thickness of the tubing Use following formula to calculate which gauge pin to use: 2 x wall thickness x 0,7 (mm) Adjustment instruction Check the range between the pump rollers and the path according to the picture below. Adjust range between the pump rollers and the path if it is necessary. HCEN12088 Revision 10.2012 • The GO pin should barely pass within the calibrating area. • The STOP pin is NOT allowed to pass in any point within the calibrating area. Maintenance manual 3:17 Note Put grease on the GO and STOP pins when not used and store the pins in a plastic bag to prevent them from corroding. Note 3:18 Maintenance manual HCEN12088 Revision 10.2012 14. Enter Service / Calibr / BM and set the AK 200 S / AK 200 ULTRA S display to: 14.1. Press the Start UF Stop button to start calibration routine. 14.2. Make sure that nothing is connected to the transducer (zero pressure) 14.3. Check zero level of the System Pressure Transducer. Tolerance: ±5 mmHg. Calibrate if necessary (see chapter Calibration manual for details). HCEN12088 Revision 10.2012 Maintenance manual 3:19 15. Enter Service / Calibr / BM and set the AK 200 S / AK 200 ULTRA S display to: 15.1. Press the Start UF Stop button to start calibration routine. 15.2. Make sure that nothing is connected to the transducer (zero pressure) 15.3. Check zero level of the Arterial Pressure Transducer. Tolerance: ±5 mmHg. Calibrate if necessary (see chapter Calibration manual for details). 3:20 Maintenance manual HCEN12088 Revision 10.2012 16. Enter Service / Calibr / BM and set the AK 200 S / AK 200 ULTRA S display to: 16.1. Press the Start UF Stop button to start calibration routine. 16.2. Make sure that nothing is connected to the transducer (zero pressure) 16.3. Check zero level of the Venous Pressure Transducer. Tolerance: ±5 mmHg. Calibrate if necessary (see chapter Calibration manual for details). HCEN12088 Revision 10.2012 Maintenance manual 3:21 17. Enter Diagnose / BM / Pumps and check that the blood pump(s) stops when the cover is opened. 18. Start the blood pump(s) and let it run at lowest possible speed. Open the blood pump cover and place a magnet (1) on the sensor for the cover. Stop the blood pump rotor by manually grabbing the handle (2). Check that the power to the blood pump motor is switched off within 2 seconds. 3:22 Maintenance manual HCEN12088 Revision 10.2012 19. Enter Service / Calibr / FM and set the AK 200 S / AK 200 ULTRA S display to: 19.1. Press the Start UF Stop button to start calibration routine. 19.2. Disconnect a tube to achieve zero pressure (see picture). 19.3. Check zero level of the Degassing Pressure Transducer. Tolerance: ±5 mmHg. Calibrate if necessary (see chapter Calibration manual for details). HCEN12088 Revision 10.2012 Maintenance manual 3:23 20. Enter Service / Calibr / FM and set the AK 200 S / AK 200 ULTRA S display to: 20.1. Press the Start UF Stop button to start calibration routine. 20.2. Disconnect a tube to achieve zero pressure (see picture). 20.3. Check zero level of the Flow Output Pressure Transducer. Tolerance: ±5 mmHg. Calibrate if necessary (see chapter Calibration manual for details). 3:24 Maintenance manual HCEN12088 Revision 10.2012 21. Enter Service / Calibr / FM and set the AK 200 S / AK 200 ULTRA S display to: 21.1. Press the Start UF Stop button to start calibration routine. 21.2. Disconnect a tube to achieve zero pressure (see picture). 21.3. Check zero level of the Flow Input Pressure Transducer. Tolerance: ±5 mmHg. Calibrate if necessary (see chapter Calibration manual for details). HCEN12088 Revision 10.2012 Maintenance manual 3:25 22. Enter Service / Calibr / FM and set the AK 200 S / AK 200 ULTRA S display to: 22.1. Press the Start UF Stop button to start calibration routine. 22.2. Disconnect a tube to achieve zero pressure (see picture). 22.3. Check zero level of the High Pressure Guard Transducer. Tolerance: ±5 mmHg. Calibrate if necessary (see chapter Calibration manual for details). 3:26 Maintenance manual HCEN12088 Revision 10.2012 23. Enter Service / Calibr / FM and set the AK 200 S / AK 200 ULTRA S display to: 23.1. Press the Start UF Stop button to start calibration routine. 23.2. Disconnect a tube to achieve zero pressure (see picture). 23.3. Check zero level of the Dialysis Fluid Pressure Transducer. Tolerance: ±5 mmHg. Calibrate if necessary (see chapter Calibration manual for details). HCEN12088 Revision 10.2012 Maintenance manual 3:27 24. Enter Service / Calibr / FM and set the AK 200 S / AK 200 ULTRA S display to: 24.1. Press the Start UF Stop button to start calibration routine. 24.2. Disconnect a tube to achieve zero pressure (see picture). 24.3. Check zero level of the Safety Guard Pressure Transducer. Tolerance: ±5 mmHg. Calibrate if necessary (see chapter Calibration manual for details). 3:28 Maintenance manual HCEN12088 Revision 10.2012 25. If installed: Calibrate the pH-sensor (FM 13) with a buffer solution. (see chapter Calibration manual for details). 26. Check the blood leak detector limits: 0 and 100 ±10. 26.1. Remove the blood leakage detector cover and clean the inside of the blood leakage detector housing. 26.2. Mount a blood leakage calibration cover (K40169001). Make sure that the filter is in horizontal position. 26.3. Enter the Service menu. 26.4. In service mode, select calibration, FM, intern and Blood Leakage Detector (FM 24). 26.5. Let the machine stabilize at 37 °C. No concentrate shall be used. 26.6. Press the Start UF Stop button to enter the blood leakage calibration routine. 26.7. Check the blood leak detector limits 0 and 100 ±10. Calibrate if necessary (see chapter Calibration manual for details). 26.8. Drain the AK 200 S / AK 200 ULTRA S dialysis machine and remount the standard blood leakage cover. 26.9. Enter the Service menu. 26.10. In service mode, select calibration, FM, intern. 27. Check the water level in the heating vessel, should be approximately 1 cm above the centre line (at the centre of the vessel according to the figure below), adjust if necessary. 28. Check the conductivity indications, at approximately 14 mS/cm. Place A-pick up tube in concentrate container and let it stabilise for 15 minutes. Use GXL – fluid monitor screen and a reference instrument connected to the dialysis fluid tubes. HCEN12088 Revision 10.2012 Maintenance manual 3:29 The indicated conductivity values in GXL should correspond to the indication on the reference instrument. The maximum deviation is ±0.1 mS/cm. 29. Check the temperature indications, at approximately 37 °C. Use GXL – fluid monitor screen and a reference instrument connected to the dialysis fluid tubes. The indicated temperature value (at the conductivity cell 2, guard) should correspond to the indication on the reference instrument. The maximum deviation is ±1.5 °C. If the deviation is more than the stated tolerance; the affected temperature transducer must be exchanged. 30. Place A-pick up tube back into the heating vessel and wait for 5 minutes. Place the B-pick up tube in the concentrate container. Enter Service menu, Calibr / FM / Other / UF / Restr. Perform an FRN calibration. 31. Let the machine pass Fch. Check the DC leakage between TP 7 (Z0VL) on the Power distribution board and the earth point on the back plate. Measure in DC Voltage, should be < 1 V. 32. Check the DC leakage between TP 7 (Z0VL) on the Power distribution board and the cover on the Degass pump motor. Measure in DC Voltage, should be < 1 V. 33. Check the DC leakage between TP 7 (Z0VL) on the Power distribution board and the Degass pump head. Measure in DC Voltage, should be < 1 V. 34. Check the DC leakage between TP 7 (Z0VL) on the Power distribution board and the cover on the Flow Out pump motor. Measure in DC Voltage, should be < 1 V. 35. Check the DC leakage between TP 7 (Z0VL) on the Power distribution board and the Flow Out pump head. Measure in DC Voltage, should be < 1 V. 36. Check the DC leakage between TP 7 (Z0VL) on the Power distribution board and the cover on the Flow In pump motor. Measure in DC Voltage, should be < 1 V. 37. Check the DC leakage between TP 7 (Z0VL) on the Power distribution board and the Flow In pump head. Measure in DC Voltage, should be < 1 V. 3:30 Maintenance manual HCEN12088 Revision 10.2012 38. If ULTRA: Calibration of internal pressure regulator. Equipment needed: Pressure reference instrument, Calibration tube set. 38.1. Let the machine pass the functional check. 38.2. Press the Fluid flow button and set the main flow to 500 ml/min. 38.3. Activate HDF or HF. 38.4. Press the Pressure control button for 3 seconds until lit. 38.5. Connect the dialyzer coupling to the conductivity cell on the pressure reference instrument. 38.6. Adjust venous pressure to +100 mmHg. Check that TMP is approximately +150 mmHg. 38.7. Connect a tube between the substitution fluid port and the external pressure reference instrument. 38.8. Press the Fluid Bypass button to obtain main flow through the pressure regulator. 38.9. Adjust the pressure regulator to +55 mmHg ±5 mmHg. To get a correct reading, the reference instrument and the test tube must be at same height as the substitution fluid port. 38.10. Press the Fluid Bypass button and remove the pressure reference instrument and tube. HCEN12088 Revision 10.2012 Maintenance manual 3:31 39. Perform a simulated treatment according to following instruction: • If the BVS is installed, switch it on. • The machine must be in volume control. • Insert a filled venous drip chamber in the level detector. • When the Priming button is flashing, simulate a venous pressure of approximately 50 mmHg. • Insert the BVS test tool, K22281001. • Set the UF-volume to 0.9 and treatment TIME to 1:00 h. • Connect a T-piece to the dialysis tubings. Put the end of the tube in a measuring glass filled with more than 1 l of water, approx. 37 °C . • Press the Fluid bypass button. Check that the tube to the measuring glass is filled with water and all air bubbles are evacuated. • Set the blood pump speed to 200 ml/min, press the priming button and start the blood pump. • Press the UF-rate button and set priming UF rate and minimum UF-rate to 0.0 l/h. • Make sure the measuring glass is filled to 1.00 l adjust if necessary. Note • It is very important to do the following things (A, B and C) more or less simultaneously i.e. within seconds. A: Simulate blood in the priming detector. B: Make sure (again) that the measuring glass is filled to 1.0 l. C: Press the Start UF Stop button. D: Press the flashing TMP button when UF rate is approximately at set value (check bargraph). • Make sure that the blood pump is not stopped by any alarm during this test since this may affect the accumulated UF volume. All kind of fluid alarms (conductivity etc.) have to be avoided. Note • Check the residual volume at TIME = 0:00 - Approved residual volume: 100 ml ±50 ml. - Approved difference between actual UF volume and UF Supervision volume is 120 ml. • The BVS test tool simulates a hemoglobin value within the range 60 – 160 g/l. 3:32 Maintenance manual HCEN12088 Revision 10.2012 When inserted into the BVS unit it is possible to check the switch, that a reference value is taken and that a graph is shown on the information display when the BVS button is pressed. The value for relative blood volume will be approx. 0% with some deviations. Do note that the blood flow must be more than 180 ml/min for 5 minutes before a reference value is taken. 40. If installed: Back-up battery Capacity-test Conditions for the test: • The back-up batteries must be fully charged, e.g. the mains plug must have been connected to mains and the mains switch on the power supply must have been on, for at least 24 h before this test is to be done. The charge indicator on the power supply is lit when the AK 200 S / AK 200 ULTRA S dialysis machine is equipped with back-up batteries. • Continue the simulated treatment from step 39. The blood pump must be running during this test. • Fill the measuring cylinder with 1 l of water. 40.1. Disconnect the mains plug. 40.2. Let the machine run in simulated treatment for at least 15 minutes. Following attention will be given. 40.3. After 15 minutes, re-connect the mains plug. Note • After the Capacity-test the machine has to be re-charged. After 24 h the back-up batteries are fully re-charged. Note If the machine stops within 15 minutes, re-connect the mains plug and the backup-batteries must be exchanged. Before the machine turns off following attention will be given. HCEN12088 Revision 10.2012 Maintenance manual 3:33 41. Check that the overload protection on the heparin pump is working. 42. Check the arterial clamp by attaching the calibration tube set into the arterial clamp. Enter priming mode and create a level detector alarm to get the clamp closed. Apply a pressure of 600 mmHg. Check that the pressure does not fall more than 30 mmHg in 15 seconds. 43. Check the venous clamp by attaching the calibration tube set into the venous clamp. Enter priming mode and create a level detector alarm, by lowering the level in the drip chamber, to get the clamp closed. Apply a pressure of 600 mmHg. Check that the pressure does not fall more than 30 mmHg in 15 seconds. 44. Connect the mains plug to the outlet supply of an electrical safety tester. Perform the Earth Leakage Test (ELT) and the Patient Earth Leakage Test (PLT) according to instructions available in Electrical safety inspection for AK-machines. 45. Perform heat/chemical disinfection. 3:34 Maintenance manual HCEN12088 Revision 10.2012 Supplementary A-kit Parts The A-kit is designed to be used as a complementary addition to the Base-kit for the preventive maintenance procedures of AK 200 S / AK 200 ULTRA S dialysis machine. The A-kit (K40166002) includes following exterior parts: Step Monitor Denomination Part no. 1 Qty FM Pick-up tube (red) K13467002 1 2 FM Pick-up tube (blue-white) K13467001 1 3 FM complete dialyzer tubing blue K40373001 1 4 FM complete dialyzer tubing red K40374001 1 5 FM Non-return valve K17978001 1 6 FM Washer, blood pump rotor K07316001 4 Note • All parts in the A-kit are possible to exchange without opening the dialysis machine. Note HCEN12088 Revision 10.2012 Maintenance manual 3:35 How to exchange the exterior parts included in the A-kit 1. Change the pick-up tube A (red). 2. Change the pick-up tube B (blue-white). 3. Change the complete dialyzer tubing blue. 4. Change the complete dialyzer tubing red. 5. Change the non-return valve on the water inlet tube. 3:36 Maintenance manual HCEN12088 Revision 10.2012 6. Add/change the washers for the blood pump rotors. Actions to carry out after the parts have been exchanged 1. First perform a heat disinfection program. Refer to the AK 200 S or AK 200 ULTRA S Operator’s Manual. 2. After the heat disinfection; re-tighten the nuts of the dialyser connector set to the machine. 3. Let the machine pass Fch. A leakage test of the dialyser connector set is performed in state 24. 4. Control of the blood pump/substitution flow pump occlusion • Check surface on the roller at the pump rotor, if it is damaged exchange the unit. • The roller unit should easily go back to upper end position when it has been pressed down to end position. Exchange unit if it gets stuck in any position. Note • If the pump segment has a different wall thickness, the occlusion of the pump must be adjusted to the correct wall thickness. Note Use the gauge pins (stop/go) available in the kit K40158001. The kit includes following three different gauge pins: T = 1.1 (Stop pin = 1.1x2x0.7 = 1.5mm) T = 1.6 (Stop pin = 1.6x2x0.7 = 2.2mm) T = 2.0 (Stop pin = 2.0x2x0.7 = 2.8mm) T = wall thickness of the tubing Use following formula to calculate which gauge pin to use: 2 x wall thickness x 0,7 (mm) HCEN12088 Revision 10.2012 Maintenance manual 3:37 Adjustment instruction Check the range between the pump rollers and the path according to the picture below. Adjust range between the pump rollers and the path if it is necessary. • The GO pin should barely pass within the calibrating area. • The STOP pin is NOT allowed to pass in any point within the calibrating area. Note • Put grease on the GO and STOP pins when not used and store the pins in a plastic bag to prevent them from corroding. Note 3:38 Maintenance manual HCEN12088 Revision 10.2012 Supplementary B-kit Parts The B-kit is designed to be used as a complementary addition to the Base-kit for the preventive maintenance procedures of AK 200 S / AK 200 ULTRA S dialysis machine. The B-kit (K40167001) includes following overhaul parts: HCEN12088 Revision 10.2012 Step Monitor Denomination Part no. 1 FM Spike kit BiCart and SelectCart cartridge holders (PEEK lower) K21557006 2 2 FM Complete valves: FOVA, DIVA, TAVA, BYVA, DRVA BCVA, TPVA, PBVA K15235A 8 3 FM Recirculation valve (complete) K15514002 1 4 FM Silicon tube (3 x 2 mm) 100312032 7 m 4 FM Silicone tube 2 x 1.5 100312166 1 m 5 FM Santoprene tube 100312141 2 m 6 BM Venous pressure line (complete) K21353A 1 7 BM Arterial pressure line (complete) K15145001 1 8 BM System pressure line (complete) K21358A 1 9 BM Pump tube (air pumps) K22114001 3 9 BM Strap (air pumps) 100314015 3 Maintenance manual Qty 3:39 How to exchange the overhaul parts included in the B-kit 1. Change the lower complete spike house and O-rings in the BiCart and SelectCart cartridge holders. Assemble according to machine configuration. 2. Change following complete valves: FOVA, DIVA, TAVA, BYVA, DRVA, BCVA,TPVA and PBVA. 3. Change complete Recirculation valve. 4. Change all the Silicone tubes in the fluid monitor. 5. Change all the Santoprene tubes in the fluid monitor. 3:40 Maintenance manual HCEN12088 Revision 10.2012 6. Change the (complete) venous pressure line. 7. Change the (complete) arterial pressure line. 8. Change the (complete) system pressure line. 9. Change the pump tubes for the air pumps. Clean the rollers with ethanol (70%). HCEN12088 Revision 10.2012 Maintenance manual 3:41 Actions to carry out after the parts have been exchanged 1. Perform a heat disinfection program. Refer to the AK 200 S or AK 200 ULTRA S Operator’s Manual. 2. Let the machine pass Fch with BiCart Select concentrate. 3:42 Maintenance manual HCEN12088 Revision 10.2012 Test after defibrillator use A defibrillator is electrical equipment which is intended to stimulate a patient’s heart during a heart failure by means of an electrical shock. The electrical output from the defibrillator is high energy pulses. This electrical shock may disturb/destroy any equipment connected to the patient. If a heart condition should occur during dialysis, it is a matter of seconds and there might not be time enough to disconnect the dialysis equipment. AK 200 S / AK 200 ULTRA S dialysis machine has been designed according to state of the art also when it comes to immunity to electrical and radio disturbances. But since there are several parameters that may vary, for instance different types of defibrillators, the settings for the defibrillator (50 - 400 Joule), skin resistance, blood and dialysis fluid conductivity and so on, it is not possible to give an accurate estimation of how much the defibrillator will affect the AK 200 S / AK 200 ULTRA S dialysis machine. According to 60601-1 clause 6 the machine is not defibrillator safe. The result of using a defibrillator while AK 200 S / AK 200 ULTRA S dialysis machine is connected to a patient may be one of the following: • No or minor disturbances in the operation of AK 200 S / AK 200 ULTRA S dialysis machine. • Disturbances that will cause a technical restart. • Technical breakdown of some components in AK 200 S / AK 200 ULTRA S dialysis machine. It is recommended that any AK 200 S / AK 200 ULTRA S dialysis machine that has been connected to a patient during defibrillation is immediately disconnected from the patient after the defibrillation. After such an incident the AK 200 S / AK 200 ULTRA S dialysis machine shall be checked by a service technician according to below: Actions, test after defibrillator use HCEN12088 Revision 10.2012 • DC leakage tests according to section “Actions to carry out after the parts have been exchanged”, paragraph 32 - 37, on page 3:28. • Earth Leakage Test (ELT) and Patient Leakage Test (PLT) according to chapter “Electrical safety inspection” on page 9:1. • Complete functional check. Maintenance manual 3:43 This page is intentionally left blank 3:44 Maintenance manual HCEN12088 Revision 10.2012 Chapter 4 Replacements Contents General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Replacement of components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ................................................... Change actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Replacement of Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . List of batteries in AK 200™ S and AK 200™ ULTRA S dialysis machines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Battery and electronic waste handling . . . . . . . . . . . . . . . . . . . . . . Replacement of power supply cord . . . . . . . . . . . . . . . . . . . . . . . . . . . HCEN9284 Revision 10.2012 Replacements 4:2 4:3 4:3 4:5 4:7 4:7 4:7 4:8 4:1 General The actions to carry out after a component replacement in AK 200 S / AK 200 ULTRA S dialysis machines are brought together in two tables: - a replacement matrix for the blood monitor (BM) - a replacement matrix for the fluid monitor (FM) The numbers in the matrix show which actions and in which order they will be done. It is important that the actions are done and in correct order. This information is a guideline for service technicians, which actions to perform when a component has been replaced. A list of all actions and explanations how to execute them is found further on in this chapter. Note • If the fluid path has been opened for troubleshooting, a heat disinfection must be performed before the machine is ready for next treatment. Note 4:2 Replacements HCEN9284 Revision 10.2012 Replacement of components HCEN9284 Revision 10.2012 Replacements 4:3 This page is intentionally left blank 4:4 Replacements HCEN9284 Revision 10.2012 Mains Cable FM components Change actions HCEN9284 Revision 10.2012 I2C scan Perform actions according to Service Manual chapter Maintenance support description, Diagnostic Flow diagram, FM. BVS test with tool K22281001 Perform actions according to instructions in the Maintenance manual. Calibrate BiCart Select Control and Protective Pump Calibrate according to calibration instructions in the Service Manual chapter Calibration manual. Calibrate BiCart Select Level detector Calibrate according to calibration instructions in the Service Manual chapter Calibration manual. Calibrate Bloodleak Calibrate according to calibration instructions in the Service Manual chapter Calibration manual. Calibrate Conductivity Cell A Calibrate according to calibration instructions in the Service Manual chapter Calibration manual. Calibrate Conductivity Cell B Calibrate according to calibration instructions in the Service Manual chapter Calibration manual. Calibrate FRN Calibrate according to calibration instructions in the Service Manual chapter Calibration manual. Calibrate Internal Pressure Regulator Calibrate according to calibration instructions in the Service Manual chapter Calibration manual. Calibrate Level detector (Air detector) Calibrate according to calibration instructions in the Service Manual chapter Calibration manual. Calibrate pH Calibrate according to calibration instructions in the Service Manual chapter Calibration manual. Calibrate Priming Detector Calibrate according to calibration instructions in the Service Manual chapter Calibration manual. Adjust inlet pressure regulator Adjust inlet pressure regulator according to Service Manual chapter Calibration manual. Calibrate Pressure Transducer Calibrate according to calibration instructions in the Service Manual chapter Calibration manual. Check BPM Check according to BPM test instructions in the Service Manual, chapter Maintenance manual. Replacements 4:5 4:6 Check conductivity value Check conductivity value according to hospital laboratory. Check/Load program (GXD) Perform actions according to instructions in Service Manual chapter Maintenance support description. Download new program version. Clean the machine from calcium and then from proteins and fats Perform actions according to Operators manual. ELT Perform the Earth Leakage Test (ELT) according to instructions available in chapter Electrical safety inspection for AK-machines. Fch Start the machine and let it perform a Fch. Heat disinfection Perform a heating according to the Operator's Manual. Load preset file Perform actions according to instructions in Service Manual chapter Maintenance support description. Occlusion Calibrate according to calibration instructions in the Service Manual chapter Calibration manual. PET Perform the Protective Earth Test (PET) according to instructions available in chapter Electrical safety inspection for AK-machines. PLT Perform the Patient Earth Leakage Test (PLT) according to instructions available in chapter Electrical safety inspection for AK-machines. Set time and date Set time and date according to instructions in the Service Manual, chapter Maintenance support description. Simulated Treatment Simulate a treatment according to instructions in Service Manual chapter Maintenance manual. Test clamp according to the Maintenance manual Test the clamps according to instructions in the Service Manual, chapter Maintenance manual. Total default Perform actions according to instructions in Service Manual chapter Maintenance support description. Replacements HCEN9284 Revision 10.2012 Replacement of Batteries List of batteries in AK 200™ S and AK 200™ ULTRA S dialysis machines The following batteries are present in AK 200 S and AK 200 ULTRA S dialysis machines: Description Type Location Battery to real time clock, 3V Lithium CR2025 Below the buzzers at the BM CPU board, B1 Battery for power failure alarm, 9V NiMH HR6F22 BM Battery backed memory, SRAM BR1632 BM CPU board. IC 65, IC10. Battery back-up during power failure, 12V, Rechargeable Lead battery LC-R127R2PG1 Below bottom tray on the monitor stand Battery and electronic waste handling Separate collection for electrical and electronic equipment Waste handling Batteries from AK 200 S and AK 200 ULTRA S dialysis machines shall not be discarded in normal waste, instead separate and proper collection systems must be used. If improperly disposed, batteries might contaminate the environment and risk the health of people. Note • Follow local legislation applicable for Battery and electronic waste handling. Note HCEN9284 Revision 10.2012 Replacements 4:7 Replacement of power supply cord To replace the power supply cord, use your thumbs to open the safety latch (retaining clip), replace the power supply cord, and then close the safety latch. Note • For safety reasons, always order the new power supply cord from Gambro. Note 4:8 Replacements HCEN9284 Revision 10.2012 Chapter 5 Maintenance support description Contents Operator's panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Treatment overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Parameter buttons and displays . . . . . . . . . . . . . . . . . . . . . . . . . Stand-by group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Alarm buttons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Display and setting group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Viewing trends on the screen . . . . . . . . . . . . . . . . . . . . . . . . . . Colours in parameter displays . . . . . . . . . . . . . . . . . . . . . . . . . . Light intensity adjustment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Light intensity on old panels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Bargraph contrast . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Backlight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Treatment overview screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Parameters shown on Treatment overview screen . . . . . . . . . . . Functional check overview screen . . . . . . . . . . . . . . . . . . . . . . . . . Tests shown on Functional check overview screen . . . . . . . . . . Maintenance support overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Access the Maintenance Support Selection . . . . . . . . . . . . . . . . . . To Exit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Logging mode overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Logging mode flow diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . Arrays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Flow Diagrams, FM with S-variables . . . . . . . . . . . . . . . . . . . . Logging diagram, S-variables for BM . . . . . . . . . . . . . . . . . . . . How to enter/exit Service/Preset mode . . . . . . . . . . . . . . . . . . . . . Preset mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PC Preset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Others . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Language version . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Time settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Total default . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Start up mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Preset of concentrates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Service mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Service mode flow diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . Blood monitor flow diagram, calibration . . . . . . . . . . . . . . . . . . Fluid monitor flow diagram, calibration . . . . . . . . . . . . . . . . . . Diagnostic flow diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Error Buffers flow diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . Diagnostics BM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Diagnostics FM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Utility flow diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ExalisⓇ flow diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Download new program version . . . . . . . . . . . . . . . . . . . . . . . . Procedure: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . HCEN9285 Revision 10.2012 Maintenance support description 5:2 5:4 5:4 5:5 5:5 5:6 5:6 5:7 5:8 5:9 5:9 5:9 5:10 5:11 5:12 5:13 5:14 5:14 5:14 5:15 5:16 5:17 5:18 5:21 5:22 5:23 5:23 5:24 5:25 5:25 5:26 5:27 5:28 5:30 5:33 5:34 5:35 5:36 5:37 5:38 5:39 5:40 5:41 5:42 5:43 5:43 5:1 Operator's panel Below follows a short presentation of the operator's panel. This is intended for the service technicians use. If you want a more detailed information about all buttons and their functions see Operator's manual. The panel consists of a number of buttons and displays. These can be divided into six logical groups: 1. Hygiene group These buttons are used to select machine modes mainly related to disinfection, rinsing and draining of the fluid monitor. 2. Mode group The buttons in this group are used to select different treatment modes. 3. Therapy group These buttons are used to initiate priming, select heparin data and special treatment therapies. The HF button is only available for AK 200 ULTRA S dialysis machine. 4. Treatment overview group This group graphically shows the status of the treatment and allows for a complete overview of all important treatment parameters. 5. Stand-by group These buttons can be used for direct control and stand-by of certain functions. 6. Display and setting group The four buttons and the set knob are used for setting of all parameters except the blood flow. The flow is always directly controlled with the Blood flow knob. The information is shown on the information display. 5:2 Maintenance support description HCEN9285 Revision 10.2012 HCEN9285 Revision 10.2012 Figure 5:1 AK 200 S Operator's panel Figure 5:2 AK 200 ULTRA S Operator's panel Maintenance support description 5:3 Treatment overview Shows graphically the status of the treatment with the displays and the flow pictures. This allows for a complete overview of all important treatment parameters within a few seconds. 1-2 Blood path The blood path lights up red when the priming detector detects blood. 3-5-7 Bypass path The bypass path is orange when the dialysis fluid is not correct. When the fluid is correct, the path is green. 3-4-6-7 Dialyzer path The dialyzer path is green when dialysis fluid passes through the dialyzer. 6-7 Ultrafiltration path The ultrafiltration path is yellow during isolated ultrafiltration and fluid bypass situations. Figure 5:3 Flow diagram Parameter buttons and displays Setting of a parameter can generally be described as follow: 1. Press the selected parameter button. The actual information will be displayed on the information display. 2. Set the value with the Set knob, (select set value or alarm limits by pressing the appropriate Arrow button). The Bargraph displays operate as follows: 5:4 • Red bars for alarm limits. • Yellow bars for actual value. • Green bars for set value. Maintenance support description HCEN9285 Revision 10.2012 Stand-by group These buttons are used to start and stop the treatment and in alarm situations. Is used to start and stop the blood pump. Is used to silence the buzzer. The buzzer will only be silenced for 30 seconds if the alarm persists. Is used to bypass the dialysis fluid. Is used for initiation and termination of treatment. It should normally not be pressed during treatment. Alarm buttons The alarm indicators are situated on the right side of the flow picture and only lights up in alarm situations. When a button flashes it is a request for the operator to press the button. Information will then be showed on the information display. Buzzer signal is combined with attention message. Attention from the operator is required. When the Technical alarm button is lit and buzzer sounds a technical fault has occurred. Enter Logging, choose Errors and read the displayed information. This information consists of different error codes, described in the Error Code List, ordering no. HCEN9313. The buzzer will be silenced with the Audio pause button. HCEN9285 Revision 10.2012 Maintenance support description 5:5 Display and setting group The information display and the four buttons together with the Set knob, are used for displaying and setting of all parameters except the blood flow. The blood flow is always directly controlled with the Blood flow knob. Viewing trends on the screen Pressing a parameter button, e.g. “Cond” will display the parameter’s set value(s) and limits in the lower part of the display. The top part will display a graph of the parameter as “trend”, i.e. the last 20 minutes. 1. Information display – goes blank after 15 “Hold” is pressed. seconds, unless 2. Blood flow knob; activates the blood flow display 3. Hold; If pressed when the information display is lit, the display is “held” forever. If pressed again, the display disappears. 4. Set knob; changes a selected value 5:6 Maintenance support description HCEN9285 Revision 10.2012 Colours in parameter displays The colours in the bargraphs are also used in the texts in the information display. The top line is black. HCEN9285 Revision 10.2012 Maintenance support description 5:7 Light intensity adjustment Note • The description below is only valid for operator’s panels with in the upper left corner of the overlay. For older the symbol panels see section “Light intensity on old panels” on page 5:9. , it is possible to find out the • If the panel has the symbol software version of the panel. In the beginning of functional check, when F.CH (capital letters) is displayed, press the Blood flow knob and the Set knob simultaneously. The software version of the panel will then be displayed in the time display. Note It is possible to adjust the light intensity for 9 different LED groups separately. The groups are: • Blue buttons • LCD screen • Bargraphs • Orange fluid flow lines • Yellow fluid flow line • Green fluid flow lines • Red blood flow lines • Time display • Red buttons To adjust the light intensity, do as follows: 1. Enter BM calibration in Service mode. For instructions on how to enter service mode, see section ”Service mode” on page 5:33. 2. Turn the Blood flow knob to find Panel Intensity (BM 10), and select it by pressing the Start UF Stop button. 3. The following is shown: Operators panel light intensity Prev. Next 4. Use the Arrow buttons below Prev. and Next to navigate between LED groups. 5. The currently selected LED group will be lit, and its intensity value will be shown in the time display. 5:8 Maintenance support description HCEN9285 Revision 10.2012 6. Use the Set knob to adjust the light intensity of the currently selected LED group. 7. To exit the Panel Intensity menu, press the Hold button. Light intensity on old panels Bargraph contrast The contrast for bargraphs is adjustable: Bargraphs With a dark display, keep the middle Arrow button (SET) depressed to light up the display. Turn the Set knob until the contrast is optimal. The setting is automatically stored (permanently). Backlight There is a possibility to adjust a back light for the push-buttons on the front panel. Press SET and then LOW push-buttons. When LOW button being pressed (keep it pressed), the SET button can be released. After 3 seconds the display will lit up. Keep the LOW button pressed and adjust the back light with the Set knob. HCEN9285 Revision 10.2012 Maintenance support description 5:9 Treatment overview screen When no other screen is displayed on the information display, the Treatment overview screen will be displayed at all times during treatment. On this screen, the operator can obtain an overall picture of parameter values, valid at that time, for the on-going treatment. All parameters are measured values except sodium and bicarbonate concentrations which are set values. If desired, the Treatment overview screen can be removed by preset and in that case the left Arrow button is to be pressed to display the screen when the information display is unlit. The picture below shows an example of the Treatment overview screen: 5:10 Figure 5:6 Treatment overview screen for AK 200 S dialysis machine Figure 5:7 Treatment overview screen for AK 200 ULTRA S dialysis machine Maintenance support description HCEN9285 Revision 10.2012 Parameters shown on Treatment overview screen Qb current blood flow rate Pa current arterial pressure Pv current venous pressure Qbacc accumulated blood volume Ps current system pressure UFR current ultrafiltration rate UFV accumulated ultrafiltration volume (patient weight loss) accumulated ultrafiltration volume (patient weight loss) as percentage of the set value TMP current transmembrane pressure Vinf accumulated infusion volume Rinf current infusion rate Na+ sodium concentration (set value) HCO3 bicarbonate concentration (set value) ΔBV relative blood volume from measurement start (BVS) time of latest measurement check (BPM, Diascan, AFM) SYS systolic blood pressure (BPM) DIA diastolic blood pressure (BPM) pulse rate (BPM) K latest measured clearance value (Diascan) Kt/V latest measured Kt/V value (Diascan) time to target is estimated to be within the remaining treatment time set (Diascan) Qa HCEN9285 Revision 10.2012 latest measured access blood flow rate Maintenance support description 5:11 Functional check overview screen The Functional check overview screen will be displayed on the information display during the functional check of the machine. The screen gives the operator information about how long the functional check has been in progress and also what is being tested at that moment. The ticks to the right of each test show that the test has been successfully performed. The green field on the progress bar shows the successfully performed part of the functional check. The time in minutes at the bottom of the screen shows elapsed time of the functional check. If desired, the Functional check overview screen can be removed by preset and in that case the Technical alarm button is to be pressed to display the screen when the information display is unlit. The picture below shows an example of the Functional check overview screen: Figure 5:12 5:12 Functional check overview screen Maintenance support description HCEN9285 Revision 10.2012 Tests shown on Functional check overview screen HCEN9285 Revision 10.2012 Fch_BM functional check of the blood monitor Fch_FM functional check of the fluid monitor, this position is the main test, tests below are more detailed and included in this ↓mS/cm test of the conductivity cell ↑mS/cm test of the conductivity cell ↑°C test of the temperature sensor °C test of the temperature sensor mmHg leakage test of the fluid monitor ↑FRN test of UF supervision system ↓FRN test of UF supervision system BiCart priming of the BiCart cartridge Maintenance support description 5:13 Maintenance support overview The Maintenance support section is inteded to be used by qualified service engineers, when performing different service related procedures of the machine. It is possible to: • Perform a LED-test of the Operator’s Panel. When the Arrow button below LED-test is pressed all buttons will remain lit. • Perform logging of different parameters when trouble shooting the machine. In Logging mode it is possible to check the condition and the status of both the hardware and the software. • Perform a Technical Error logging. • Enter Preset/Service-mode (via an access code). Access the Maintenance Support Selection The Maintenance support is accessed by simulataneously pressing the three Arrow buttons below the screen at the same time for 3 seconds. To Exit Press the Hold button to exit from Maintenance Support . 5:14 Maintenance support description HCEN9285 Revision 10.2012 Logging mode overview In the Logging mode it is possible to check the condition and the status of both the hardware and the software. There are three types of logging facilities, internal logging (Intern), External logging (Extern) and technical error logging (Errors). The actual information is shown on the information display, which can be divided into different sections (0 - 2). To look at two or three different parameters simultaneously, use the possibility to select a separate field on the information display for each parameter. HCEN9285 Revision 10.2012 Maintenance support description 5:15 Logging mode flow diagram 5:16 Maintenance support description HCEN9285 Revision 10.2012 Arrays When you press the Arrow button below "Arrays" and then turn the Set knob you will find a number of different codes. The arrays used for service purpose are: SRI SRL SRR SRW SP SF SRB The different letters stands for: First letter: S: Service logging parameters Second letter: R: RAM variable P: Process F: Function Third letter: B: Byte (0-25) I: Integer (whole numbers) L: Logic (True / False) R: Real (floating point numbers) W: Word (0-65535) Use the Set knob when you select arrays and press the Hold button when you want to step backwards. When it is necessary to look at two or three different arrays at the same time, use the possibility to choose a separate field on the information display for each data. Summary: 1. Set field 2. Set array 3. Set index 4. Set format 5. Press the Hold button twice 6. Press the Arrow button below "Display" and you receive text with a value on a given section. HCEN9285 Revision 10.2012 Maintenance support description 5:17 Flow Diagrams, FM with S-variables AK 200™ S dialysis machine Flow path 5:18 Maintenance support description HCEN9285 Revision 10.2012 AK 200™ S UFD dialysis machine Flow path HCEN9285 Revision 10.2012 Maintenance support description 5:19 AK 200™ ULTRA S dialysis machine Flow path 5:20 Maintenance support description HCEN9285 Revision 10.2012 Logging diagram, S-variables for BM BM 202, S-variables HCEN9285 Revision 10.2012 Venous blood pump Pump cover open = SRL (24) Blood flow = SRI (84) Arterial blood pump Pump cover open = SRL (25) Blood flow = SRI (83) Level detector Level det. transmit level = SRB (0) Level det. comparator level = SRB (89) Priming detector High level = SRB (1) Low level = SRB (2) Blood = SRL (23) Venous clamp Clamp active = SRL (2) Clamp status = SRL (30) Closed = SRL (34) Arterial clamp Clamp active = SRL (28) Clamp status = SRL (29) Closed = SRL (33) Venous pressure transducer SRI (1) Arterial pressure transducer SRI (82) System pressure transducer SRI (0) BM board temperature SRI (17) Blood volume sensor, BVS BVS on = SRL (104) BVS installed = SRL (105) Heparin pump Est. Acc. heparin volume (ml) = SRI (88) Accumulated heparin volume (ml) = SRI (87) Overload = SRL (26) Heparin Fch check counter = SRI (98) Maintenance support description 5:21 How to enter/exit Service/Preset mode Note • Only service engineers fulfilling the minimum level of competence, according to AK 200 S / AK 200 ULTRA S Service manual, "Competence of Service Engineers" are allowed to enter the Service/Preset-mode to repair or maintain AK 200 S / AK 200 ULTRA S dialysis machines in the field. • The access code (XX, YY, ZZ) to enter Service/Preset mode is available via your local Gambro Service representative. Note To enter Service / Preset mode, press the Arrow button below ServPres and you will be asked to set the service code: Set the code with the Set knob (two digits for each button). If you do not press the Arrow buttons within 30 seconds, restart from the first figure is required. Note • The remaining time must be set at 0.00 before the presetting can start. Note Select the desired mode by pressing the Arrow button below this mode. To exit from Service or Preset mode, press the Hold button below Fch. AK 200 S / AK 200 ULTRA S dialysis machine will restart and perform a functional check, Fch. 5:22 Maintenance support description HCEN9285 Revision 10.2012 Preset mode In Preset mode, it is possible to customise the AK 200 S / AK 200 ULTRA S dialysis machine. For more information, contact Gambro service. The choices are listed below: • Machine configuration • PC - preset program • Language version for the display • Time settings • Total default • Start up mode • Preset of concentrates Select Preset. Note • All preset values and limits must be verified before treatment start. • Preset concentrates must be verified by laboratory test of the dialysate produced by the AK 200 S / AK 200 ULTRA S dialysis machine. • Preset for pump segments must be verified by comparing the pumped volume and a reference volume. Note Configuration 1. Choose the Arrow button below Config to select unit. Config - Configuration PC Pres - Preset with PC Others - Language, clock and defaults 2. HCEN9285 Revision 10.2012 Maintenance support description 5:23 3. To configure the unit, turn Set knob and confirm by pressing the Arrow button below REF SET. 4. Press the Start UF Stop button to store the configuration. This procedure is applicable for the following alternatives: • pH (installed/not installed) • BM 200/202 (either) • System pressure transducer (installed/not installed) • BVS (installed/not installed) • RS 232 / RS 422 (either) • BPM (installed/not installed) • Diascan (installed/not installed) • Access flow (installed/not installed) • Voltage (230 V/115 V) 5. To return, press the Hold button. PC Preset In this mode it is possible to preset several hundred parameters and start up values with help of a PC and the GXP - Gambro eXternal Preset -program”. This set up is used for customising (within certain limits) AK 200 S / AK 200 ULTRA S dialysis machine. For more information, contact Gambro service. EXTERNAL PC PRESET MODE $$# See separate manual for GXP. 5:24 Maintenance support description HCEN9285 Revision 10.2012 Others Language version 1. Select the Arrow button below Others to set language, clock or defaults. 2. Select the Arrow button below Language. 3. To select language, turn the Set knob. Select the button below REF SET. The button will stop flashing and will then go out. The following languages are available: - Czech - Danish - Dutch - English - Finnish - French - German - Greek - Hungarian - Italian - Norwegian - Portuguese - Russian - Serbian - Spanish - Swedish - Turkish - Polish - Slovak - Slovenian 4. Press the Start UF Stop button to store the chosen language. 5. To leave the Language menu, press the Hold button. HCEN9285 Revision 10.2012 Maintenance support description 5:25 Time settings 1. Select the Arrow button below Others to set language, clock or defaults. 2. Choose the Arrow button below Clock. To set year/day of the week select the left Arrow button, to set month and day select the middle Arrow button and to set hour and minute select the right Arrow button. Turn the Set knob to change the value, press Arrow button to confirm 3. To save changes and show the chosen time, press the Start UF Stop button. 4. To leave the Clock menu, press the Hold button. 5:26 Maintenance support description HCEN9285 Revision 10.2012 Total default Note • A total default will change all customize presets to the standard factory settings. Note 1. Select the Arrow button below Others to set language, clock or defaults. 2. Choose the Arrow button below Default. 3. Press the Start UF Stop button to store the preset. This confirms that the AK 200 S / AK 200 ULTRA S dialysis machine consists of a BM 200 without pH monitoring or other options (standard AK 200 S / AK 200 ULTRA S dialysis machine). 4. To return, press the Hold button twice. HCEN9285 Revision 10.2012 Maintenance support description 5:27 Start up mode The start up values for AK 200 S / AK 200 ULTRA S dialysis machines are set in the same way as other presets. Following values can be preset by pressing appropriate button: SN/DN, SP/DP Default: DN, SP Volume control/Pressure control Default: Volume control Heparin Volume (10.0 - 30.0 ml) and length (31.0 -119.0 mm) of syringe. Default: volume 30.0 ml, length 81.0 mm. Time (start up) Default: 4.00 Venous pressure window Default: mmHg, Low Level 0 Set 200 High Level 1000 Blood flow Default: pump segment, mm Alt1, 7.90 Alt2, 6.35 Alt3, 4.00. Note that AK 200 S / AK 200 ULTRA S dialysis machine has to be in DN mode to be able to adjust the blood line inner diameter and the blood pump has to be stopped. For adjustment of the occlusion, please see the Calibration Manual. SN data Default: System press, mmHg LL 10 HL 175 Temp Default: LL 35.0° C Set 37.0° C HL 39.0° C Cond Default in Acetate mode: 140 mmol/l Default in Bicarbonate mode: Na=140 mmol/l HCO3=34 mmol/l Arterial pressure window Default: alarm limit, mmHg LL 0 Set 150 HL 2000 UF rate Default: In TMP mode LL 0.00, HL 1.50 UF priming rate 0.10 Minimum UF rate 0.00 5:28 Maintenance support description HCEN9285 Revision 10.2012 pH Default: alarm limit Acetate, LL 6.0, HL 8.0 Bicarbonate, LL 6.5, HL 7.8 Acetate / bicarbonate Default: bicarbonate Degassing pressure (bypass button) Recommended degassing pressure according to the table below. Default Acetate: mmHg LL -700, Set -630, HL -500 Default Bicarbonate: mmHg LL -700, Set -580, HL -500 Degassing pressure table The degassing pressure can be preset between -500 to -700 mmHg. This is used when AK 200 S / AK 200 ULTRA S dialysis machine is operating at high altitudes, see table below. In acetate mode Altitudes (m) Normal air pressure Recommended degassing pressure Water boiling temperature (mmHg) (mmHg) (°C) 0 760 -630 100 500 710 -580 98.1 1000 663 -530 96.2 1500 620 -490 94.4 2000 580 -450 92.6 2500 540 -410 90.7 Normal air pressure Recommended degassing pressure Water boiling temperature (mmHg) (mmHg) (°C) 0 760 -580 100 500 710 -530 98.1 1000 663 -490 96.2 1500 620 -450 94.4 2000 580 -410 92.6 2500 540 -370 90.7 In bicarbonate mode Altitudes (m) Note • This variable is ignored if altitude preset, S550 is greater than 500 (m) Note HCEN9285 Revision 10.2012 Maintenance support description 5:29 Preset of concentrates Enter Preset mode. • To preset acetate concentrate, press the Acetate button. • To preset bicarbonate concentrate, press the Bicarbonate button. The default presets are: • Acetate: mmol/l and ions. • Liquid bicarbonate: mmol/l and molecules. • BiCart cartridge: mmol/l and ions. Three different concentrates can be preset for acetate and bicarbonate. Following example will show how to preset the AK 200 S / AK 200 ULTRA S dialysis machine for BiCart A-concentrate 201. All values which are going to be set are specified at the label on the concentrate containers. Note! If the values are present as both concentrated and diluted concentrate, use the concentrated values. 1. When the Bicarbonate button is selected, following will be displayed: SELECT BICARBONATE PRESET Start up Concentrate Select Concentrate. 2. Select where to store concentrate (alt 2). SELECT CONCENTRATE ALTERNATIVE alt 1 alt 2 alt 3 Note • It is not possible to change Bicarbonate alternatives manually (alt 1). Please use external preset. Note 3. Select mmol/l. BICARBONATE PRESET UNITS gram/l mmol/l 5:30 Maintenance support description HCEN9285 Revision 10.2012 4. Select ion representation. PARAMETER REPRESENTATION ion molecule 5. Push the Arrow button below select pos to set cursor IONS mmol/l $$$$#.## select pos 6. Set cursor position at the digit which is going to be changed, with the Set knob. To confirm the cursor position, press the Arrow button below A: Na. Set desired value with the Set knob. IONS mmol/l Forw $$$$#.## Backw 7. To confirm selected value and change cursor position, press Arrow button below select pos. All values for the concentrate are set in this way. IONS mmol/l $$$$#.## select pos 8. When ready to continue with the next part in the concentrate, press Forw to confirm the value, or step backwards by pressing Backw. IONS mmol/l Forw $$$$#.## Backw 9. Choose Liquid or BiCart on the concentrate. IS B-PART LIQUID OR BiCart? Liquid BiCart 10. When all the values for the concentrate are set, the display shows: SET LABEL USER LABEL select char Turn the set knob to change the character. Press the Arrow button below select char. HCEN9285 Revision 10.2012 Maintenance support description 5:31 11. Turn the set knob to change the cursor position. Press the Arrow button below BiCart to change the selected character. SET LABEL Forw USER LABEL Backw 12. Press the Arrow button below Forw when the concentrate label is correct. PARAMETER CALCULATION Press HOLD key to abort 13. Press the Start UF Stop button to write preset parameters in EEPROM, or step backwards for change of values by selecting Backw. STORE IN EEPROM Press START/STOP key Backw Note • Preset concentrates must be verified by laboratory test of the dialysate produced by the AK 200 S / AK 200 ULTRA S dialysis machine. Note 5:32 Maintenance support description HCEN9285 Revision 10.2012 Service mode Press the Arrow button below "Service" to enter service mode. Choose Calibration (Calibr), diagnostics (Diagnose) or utilities (Util) with the appropriate button. When you are in the service mode and want to step back, press the Hold button. When you leave the Service mode, the AK 200 S / AK 200 ULTRA S dialysis machine will restart and perform a Fch (functional check). HCEN9285 Revision 10.2012 Maintenance support description 5:33 Service mode flow diagram 5:34 Maintenance support description HCEN9285 Revision 10.2012 Blood monitor flow diagram, calibration HCEN9285 Revision 10.2012 Maintenance support description 5:35 Fluid monitor flow diagram, calibration 5:36 Maintenance support description HCEN9285 Revision 10.2012 Diagnostic flow diagram HCEN9285 Revision 10.2012 Maintenance support description 5:37 Error Buffers flow diagram Diagnostic error buffer Sequential error buffer. 10 last errors are saved. Time from power on for each error is also saved. Buffer is not cleared at power on. (see example below) Transient error buffer Transient error during buffer that affects treatment. 10 errors are saved. Buffer is cleared at power on. Permanent error buffer Normal error buffer that affects treatment. 10 errors are saved. Buffer is cleared at power on. 5:38 Maintenance support description HCEN9285 Revision 10.2012 Diagnostics BM HCEN9285 Revision 10.2012 Maintenance support description 5:39 Diagnostics FM 5:40 Maintenance support description HCEN9285 Revision 10.2012 Utility flow diagram In utility it is possible to interrupt the chemical disinfection phase for service purposes. This is only intendend to be used as a service tool. WARNING Check that no disinfection solution has been taken in, if so a complete Chemical rinse program must be performed. WARNING HCEN9285 Revision 10.2012 Maintenance support description 5:41 ExalisⓇ flow diagram 5:42 Maintenance support description HCEN9285 Revision 10.2012 Download new program version It is possible to download software via the Ethernet connector at the FM power distribution board, as a complement to the serial communication port. Tools needed: • PC. • Crossover twisted pair cable, 210220002. • GXD (version 1.30 or higher). Procedure: 1. Switch on the machine and enter Service/Util/Others/Exalis/Network. At the computer: 2. Enter Start/Settings/Control Panel/Network Connections. 3. Right click at “Local Area Connection” and select “Properties”. 4. Scroll to “Internet Protocol (TCP/IP)”. 5. Mark it and select “Properties”. 6. Tick the “Use the following IP address”. 7. Set an IP address in the same span as shown at the machine (default 192.168.0.200). Do not set the same number. 8. Use the default Subnet mask (255.255.255.0). Press “OK”. At the dialysis machine: 9. Enter “bootload”. HCEN9285 Revision 10.2012 Maintenance support description 5:43 10. Connect the computer to the dialysis machine’s Ethernet connector. Use a crossover twisted pair cable. At the computer: 11. Start GXD (version 1.30 or higher). 12. Set “Ethernet” as the Com Port. 13. Press “Start”. 14. A pop up dialog box will appear, select or set a group. 15. Set the machine’s IP address or select the address from the list. If a new IP address is set, press “Add”. Select the IP address. Press “OK”. Note • The download from computer to machine (IT Expansion board) takes approximately 10 seconds. Note 16. A pop up dialog box will appear. 17. If all bytes have been transferred, press “OK”. 5:44 Maintenance support description HCEN9285 Revision 10.2012 The transfer of data from computer to IT Expansion board is now finished. 18. Disconnect the computer. Note • The transfer from IT Expansion board to dialysis machine, internally, will continue and will take approximately 10 minutes in total. During this process “boo” will be shown in the dialysis machine’s time display. When the process is ready the dialysis machine will automatically restart and enter preset mode. Note HCEN9285 Revision 10.2012 Maintenance support description 5:45 This page is intentionally left blank 5:46 Maintenance support description HCEN9285 Revision 10.2012 Chapter 6 Technical description Contents Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Main functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Quick preparation procedures . . . . . . . . . . . . . . . . . . . . . . . Treatment flexibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Others . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Fluid Monitor, FM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . FM flow diagram AK 200™ ULTRA S dialysis machine . . . . . . . . Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Water intake . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Concentrate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Concentrate - FM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . BiCart SelectⓇ System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Dialysis Fluid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Design and Construction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . FM valves . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Electrical circuit boards used in the fluid monitor . . . . . . . . . . . . . FM CPU board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . FM Analog Distribution board . . . . . . . . . . . . . . . . . . . . . . . . . FM Power Distribution board . . . . . . . . . . . . . . . . . . . . . . . . . . Blood leak Detector board . . . . . . . . . . . . . . . . . . . . . . . . . . . . Conductivity cell board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Blood pressure monitor board . . . . . . . . . . . . . . . . . . . . . . . . . . Blood Monitor, BM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Double Needle Treatment - HD . . . . . . . . . . . . . . . . . . . . . . . . Single Needle Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Single Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Double Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Double Needle Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . HDF Low Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . HDF on line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . HF on line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Design and Construction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Level Detector (Air detector) . . . . . . . . . . . . . . . . . . . . . . . . . . Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Blood Pump Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . BVS - Blood Volume Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . Drip Chamber Level Adjustment . . . . . . . . . . . . . . . . . . . . . . . Fan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Heparin Pump Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Line Clamp Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Operator's Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Pressure Transducers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Priming Detector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . HC9286 Revision 10.2012 Technical description 6:3 6:3 6:5 6:5 6:5 6:5 6:5 6:5 6:6 6:7 6:8 6:9 6:9 6:9 6:10 6:10 6:11 6:16 6:24 6:27 6:27 6:30 6:30 6:30 6:31 6:31 6:32 6:33 6:33 6:34 6:34 6:35 6:36 6:36 6:36 6:37 6:38 6:38 6:38 6:38 6:38 6:39 6:39 6:39 6:39 6:39 6:40 6:40 6:1 BPM - Blood Pressure Monitor . . . . . . . . . . . . . . . . . . . . . . . . . Electrical circuit boards used in the blood monitor . . . . . . . . . . . . . BM Analog Distribution Board . . . . . . . . . . . . . . . . . . . . . . . . . Panel Control Board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . BM CPU Board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Power Supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Monitor stand . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:2 Technical description 6:40 6:42 6:42 6:43 6:44 6:46 6:48 HC9286 Revision 10.2012 Introduction General Note • This chapter only describes AK 200 ULTRA S dialysis machine. Be aware of the differences between AK 200 S and AK 200 ULTRA S dialysis machines and therefore only use it as a reference! Note The Gambro AK 200 ULTRA S System is intended for use as a single patient machine to perform hemodialysis (HD), hemodiafiltration (HDF) and hemofiltration (HF). The System is also intended for on-line preparation of substitution fluids (see below) to be used in HDF and HF. The AK 200 ULTRA S System comprises of two monitors; one blood monitor (BM 202) and one fluid monitor (FM 202). The monitors are placed on a mobile stand (MS 200 or MS 202). The blood monitor is designed to control and supervise the extracorporeal blood circuit. Single needle treatment can in hemodialysis be performed with one pump (double clamp function) or with two pumps. To prevent coagulation, heparin may be administered by means of a heparin pump. Single needle treatment can be carried out with one or two blood pumps. Double needle treatment is carried out with only one blood pump. Hemofiltration or hemodiafiltration is only carried out in double needle treatment. The second pump is acting as substitution pump in these modes. Disposable lines are used for the blood and the substitution flow. HC9286 Revision 10.2012 Technical description 6:3 The fluid monitor is designed to produce the dialysis and substitution fluid at a desired temperature, conductivity and pressure within given specifications. It shall supervise the fluid and transport the fluid through the dialyzer. The fluid monitor maintains the dialysis flow through the dialyzer/filter with controlled ultrafiltration or controlled TMP1. When a fault occurs, the fluid monitor bypasses the dialyzer. The monitor also detects blood leaks in the dialyzer. Both acetate and bicarbonate treatments can be performed. The on-line production of substitution solution can be deactivated and the AK 200 ULTRA S dialysis machine can be used for HDF with bags. The dialysis fluid consists of water and concentrate. The fluid monitor operates either in acetate or bicarbonate mode. In bicarbonate mode the monitor mixes dialysis fluid from water and two concentrates: acid and bicarbonate. The mode is selected from the operator’s panel. When AK 200 ULTRA S dialysis machine is used to produce bicarbonate containing dialysis fluid originating from non-liquid concentrates, it is designed and validated for use with the BiCart system. When AK 200 ULTRA S dialysis machine is used to produce sodium chloride containing dialysis fluid originating from non-liquid concentrates, it is designed and validated for use with the BiCart Select system, i.e. the SelectCart cartridge and SelectBag concentrate. The fluid monitor should be disinfected after every treatment. The AK 200 ULTRA S dialysis machine is disinfected according to the Operator’s Manual, with either chemical disinfectants or with heat disinfection. The fluid monitor also includes a power supply and a heat exchanger. The MS 200 includes pressure regulator, infusion stand, a double filter holder for two ultrafilters and a bottom tray. The system is operated from the operator’s panel located on the blood monitor. For information about the use and function of the operator’s panel, see chapter Maintenance support description, or the AK 200 ULTRA S Operator’s Manual. 1 TMP is defined as the difference Pb out - P d out + 18.4 mmHg, where Pb out is the venous drip chamber pressure and Pd out is the pressure measured in the dialysis fluid where it enters the machine after the dialyzer. The offset of 18.4 mmHg compensates for the vertical distance between the pressure sensors. 6:4 Technical description HC9286 Revision 10.2012 Main functions The AK 200 ULTRA S dialysis machine includes the following main functions: Quick preparation procedures • Automatic self test • Presetable treatment parameters Treatment flexibility • Standard or high-flux HD with ultrapure dialysis fluid • On-line HDF, with pre- or postdilution • On-line HF, with pre- or postdilution • On-line preparation of substitution fluid for HF and HDF • Adjustable dialysis fluid flow rate 300-700 ml/min • Profiling of Na+ and HCO3-, and UF • Designed for BiCart Select® system • Blood volume measurement, BVS • SN/SP and SN/DP with low recirculation • Isolated UF Disinfection • Chemical and heat disinfection • Automatic disinfection, integrated disinfection • CleanCart™ cleaning, decalcification, disinfection • Chemical disinfection memory Options • pH 200 K18266001 • Battery Backup K18614001 (24V) • Electrically adjustable stand, MS 200 Others HC9286 Revision 10.2012 • Automatic Power On Test • External Logging via PC, GXL • Presetting of system parameters (internal or via external PC) • Download of new software via PC, GXD Technical description 6:5 Parameters System and treatment parameters can be set at five different levels (Table1). Level Type of parameters Presetable by: 4 Treatment parameters Operator, nurse 3 Alarm limits and defaults Clinic's technician 2 New functions Gambro technician or Gambro subsidiary 1 Adaptions Gambro Head office 0 Safety limits Fixed For information about setting the parameters in level 2 and 3, see chapter Maintenance support description. For information about the use and functions of the parameters in level 4, see the AK 200 ULTRA S Operator’s Manual. 6:6 Technical description HC9286 Revision 10.2012 Fluid Monitor, FM HC9286 Revision 10.2012 Technical description 6:7 FM flow diagram AK 200™ ULTRA S dialysis machine 6:8 Technical description HC9286 Revision 10.2012 Treatment Water intake Feed water passes via a pressure regulator, an inlet valve, a heat exchanger and an ultra filter to a heating vessel. The ultra filter is continuously flushed with a certain flow, approx. 50-100 ml/min. that goes directly to drain via a restrictor. The feed water must fulfil the ASAIO and AAMI standards on feed water for dialysis monitors. The pressure regulator reduces pressure to a maximum of 1 bar. The temperature of the incoming water is raised a couple of degrees in the heat exchanger. This reduces the power consumption of the heating elements. The inlet valve (INVA) is normally open. The water level in the heating vessel is regulated by means of a float valve in the bottom of the heating vessel. The float valve is closed when the water level reaches maximum and is opened when it falls to minimum. The flushing valve (FLVA), which is used during disinfection, is closed during treatment. A non-return valve, placed between the recirculation loop, in front of the return flush valve (RFVA) and behind the inlet water valve (INVA) is used to enable disinfection of the first ultra filter. The temperature transducer in the heating vessel measures the water temperature and controls the heating. The heating vessel has two heaters and a stirrer. The stirrer is used to ensure a constant water temperature. From the heating vessel the feed water passes via a filter and a restrictor to an expansion chamber. The function of the restrictor is to produce the negative pressure that is necessary for degassing the fluid. The bubbles are separated in the degassing chamber. The recirculation is controlled by a stepping motor. The degassing restrictor bypass valve (DRVA), which is used during disinfection, is closed during treatment. Constant pressure in the expansion chamber and constant level in the degassing chamber are maintained by means of the degassing pump and the recirculation valve. Concentrate The dialysis fluid is a mixture of water and acetate based concentrate. (Salt is added to the water in order to prevent the essential salts in the blood from passing through the membrane in the dialyzer into the dialysis fluid). Water and concentrate are mixed in the expansion chamber. The amount of concentrate is regulated by the feed pump (piston pump). The amount of concentrate to be added is determined by measuring the conductivity of the fluid. Conductivity is the ability of the fluid to conduct electricity. (The conductivity cell is used to measure the conductivity of the fluid.) The conductivity depends on HC9286 Revision 10.2012 Technical description 6:9 the dialysis fluid temperature (approx. 1.8% per °C). The temperature transducer in the conductivity cell is used to measure the temperature of the fluid and as certain the correct conductivity value (to compensate for temperature fluctuations). If conductivity is outside the preset limits, the dialyzer is bypassed and the dialysis fluid goes directly to the drain (the direct valve - DIVA - is closed and the bypass valve - BYVA - is opened). This situation may arise if there is not sufficient concentrate, the concentrate pick-up tube is not properly inserted in the concentrate container, the flow through the tube is obstructed or the water supply is insufficient. The proportioning bypass valve - PBVA - is closed during treatment. The PBVA is open during disinfection. The reason for this is that there is an under pressure after the feeding pump. When the fluid monitor is disinfected, the system can be quickly filled with disinfectant if the PBVA is open. Concentrate - FM The FM can operate in either acetate mode or bicarbonate mode (selectable by the operator). The concentrate (acetate) is fed in via the Binlet. In bicarbonate mode two concentrates are used, referred to as A- and B-concentrates. First the A-concentrate is mixed with water in the mixing chamber. The fluid then passes to the expansion chamber, where the B-concentrate is added. The amounts of concentrate are regulated with two feed pumps (piston pumps). The conductivity is measured by means of two cells. The conductivity cell in unit 1 measures the conductivity at the first stage. The second cell measures conductivity after the B component has been added. BiCart SelectⓇ System The BiCart Select system is a concept for preparing the A- and B-concentrate in bicarbonate dialysis treatments. The A-concentrate is prepared “on-line” during the treatment from the SelectBag container, containing the small electrolytes in a highly concentrated solution, and from the dry sodium chloride cartridge, SelectCart. The bicarbonate concentrate is continuously prepared from the dry bicarbonate powder contained in the BiCart cartridge. The BiCart Select system improves transportation, storage and handling efficiency. It introduces a possibility for individualized sodium and bicarbonate concentrations, independent from the prescribed concentrations of the small electrolytes. The control system feeds the contents of the SelectBag container in a volumetric proportion (1:200) to the dialysis fluid flow rate. 6:10 Technical description HC9286 Revision 10.2012 The flow of sodium chloride solution from the SelectCart cartridge is controlled using the ordinary A-step control loop but the B-step is unchanged. The use of AK 200 ULTRA S dialysis machine with BiCart Select system is equal to the use of standard treatments with one exception: • Select concentrates do not run with any canister bicarbonate but only with BiCart cartridge. The correct proportioning of the minor electrolytes is monitored by the protective pump and an infrared level detector. The level detector consists of an IR-LED and an IR transistor placed on a fluid chamber. A saturated solution of sodium chloride (NaCl) is produced from dry salt contained in the SelectCart cartridge. Both components are mixed on-line to produce the A-concentrate. The mixing of this acidic concentrate with water is conductivity controlled. Bicarbonate concentrate is produced separately by means of the BiCart cartridge. Its mixing is also conductivity-controlled. The final supervision of the dialysis fluid is performed by an independent conductivity cell. PAVA and PBVA are open during the priming of the SelectCart and the BiCart cartridges. Dialysis Fluid The dialysis fluid is forwarded by the degassing pump (gear-wheel pump) to the bubble trap. The restrictor and the flow pump produce a negative pressure (approx. -600 mmHg), that separates the air from the fluid. The air is led from the degassing chamber back to the heating vessel (there is atmospheric pressure in the degassing chamber). The flow pump is also used to regulate the fluid level in the degassing chamber. The level is monitored by a level detector. It is very important that the dialysis fluid should have the correct conductivity. It is very important that the system is able to detect if an incorrect concentrate is being used. The pH sensor (optional) is used as an improved safeguard against faulty and/or incorrect concentrates. (There is some disinfection solutions that can give correct conductivity. But these solutions do normally not have the correct pH value.) If the concentrate pick-up tubes are incorrectly inserted, this will also produce an incorrect pH value. After the pH-sensor there is a flow reducer and a bypass valve (FOVA). The function of the flow reducer is to create a negative pressure. The main flow is variable between 300 and 700 ml/min. The bypass valve FOVA (closed during treatment) is used in disinfection mode. The flow through the dialyzer is controlled by means of two pumps: flow output pump and flow input pump HC9286 Revision 10.2012 Technical description 6:11 (gear-wheel pumps). The function of the pumps is to maintain a constant flow, to and from the dialyzer. Treatment can be either volume controlled (UF) or pressure controlled (TMP). The mode is selected from the operator’s panel. In both UF and TMP mode, a variable main flow (300 - 700 ml/min) to the dialyzer is obtained by means of the flow output pump. The pressure over the flow reducer is adjustable, and thereby, a variable main flow is obtained. Constant flow after the dialyzer is obtained by means of the flow-input pump. The input flow is normally higher than the output flow. Dialysis patients are water retentive and the excess is removed during treatment. The UF rate is a measure of the quantity removed. If the output flow is 500 ml/min, the input flow may, for example, be 502 ml/min. In UF mode, the differential flow from the UF measuring cell and the required UF rate (selected by the operator) is used to regulate the flow input pump so that the desired pressure is obtained. After the flow input pump there is a positive pressure. In TMP mode, TMP is used to regulate the flow input pump. The UF measuring cell is used to measure the UF rate, but the measuring cell is not involved in the regulation of the flow input pump. Every 30 minutes during treatment, the UF measuring cell is automatically calibrated to ensure correct performance. (This has to be done because waste products in the fluid returned from the patient may be deposited in layers on the inside of the measuring channels.) The calibration can be divided into three phases. During phase 1 the UF measuring system is calibrated. During phase 2 the UF measuring unit and the dialyzer are bypassed, i.e. there is no fluid passing through neither of the two channels (DIVA, TAVA, and BYVA valves are closed and ZEVA valve is open). Thus the offset of the two measurement channels can be measured. Finally during phase 3 the dialysis fluid bypasses dialyzer but passes through the UF measuring unit, i.e. the same amount of fluid is passing through both channels of the UF measuring cell (DIVA, TAVA, and ZEVA valves are closed and BYVA valve is open). With channel 1 as a reference, channel 2 can be calibrated. The UF rate is now zero. Calibration takes totally about 60 - 90 seconds. Treatment is then resumed. After the UF measuring cell there is a pressure transducer (high-pressure guard) which is activated if the pressure before the dialyzer becomes too high. For example, if there is a blockage somewhere in the tubes, the high pressure guard is activated, the flow is stopped and the system goes into bypass mode (see below). The bypass unit includes high-pressure guard and two valves: the direct valve (DIVA) and bypass valve (BYVA). The direct valve is normally open during treatment (if the temperature, pressure, conductivity etc. are within the predefined limits). In an emergency situation (e.g. in the event of a blood leak being detected), the direct valve is closed and 6:12 Technical description HC9286 Revision 10.2012 the bypass valve is opened. The dialysis fluid is led past the dialyzer directly to the drain. The following situations result in a bypass: • Blood leak detected • Temperature out of limits • Conductivity out of limits • pH alarm (optional) • Technical error message From the direct valve (DIVA) the dialysis fluid is forwarded to a second ultra filter and further on through an infusion-outlet-port, a pressure regulator and the clean water valve (CWVA). The infusion line set is connected to the infusion outlet-port to access the infusion solution. The solution is forwarded to a single use filter. The integrity of this sterile filter has been tested (for every filter) during manufacturing. The pressure regulator is used to always maintain a positive fluid pressure (approx. +50 mmHg) to ensure that the infusion line segment does not collapse during operation. The filter valve (FIVA), closed during treatment, is used for disinfection of the second ultrafilter. From the clean water valve (CWVA) the dialysis fluid is passed on to the dialyzer or in bypass mode to drain. In hemofiltration mode (HF mode) the clean water valve (CWVA) is always in bypass mode but for hemodialysis mode (HD mode) or hemodiafiltration mode (HDF mode) it may operate in both modes. The dialysis fluid is forwarded to the dialyzer via the output tube. From the dialyzer the dialysis fluid (mixed with waste products) is returned to the fluid monitor via the input tube. The input tube nipple is fitted with a filter. The taration valve (TAVA) is normally open. During the UF measuring cell calibration, the taration valve is closed. The zero setting valve (ZEVA) is normally closed. During the UF measuring cell calibration phase 2, the zero setting valve is open. The pressure transducer, Pd, measures the dialysis fluid pressure. The measurement is used in the calculation of the TMP. The pressure transducer also activates an alarm if the pressure becomes too high. The dialysis fluid is fed to the bubble trap. The function of the bubble trap is to separate air from the fluid. For example, a leakage may occur in the dialyzer. When the fluid level in the bubble trap reaches the minimum level, i.e. when there is too much air in the vessel, the evacuation valve (EVVA) is opened and the air is released. The fluid level is monitored with a level detector. HC9286 Revision 10.2012 Technical description 6:13 The blood leak detector detects any blood in the dialysis fluid. In the event of the slightest leak between the blood side and dialysis fluid side of the dialyzer, an alarm will be activated. If blood is detected, the system goes into bypass mode. The emptying valve (EMVA), which is closed during treatment, is used to empty the blood leak detector when treatment is completed. Finally, the dialysis fluid is led to the drain via the flow-input pump and heat exchanger. 6:14 Technical description HC9286 Revision 10.2012 This page is intentionally left blank HC9286 Revision 10.2012 Technical description 6:15 Design and Construction Following section describes the sub-units, the valves and the electrical boards used in the fluid monitor. 1. Internal Pressure Regulator 2. Blood leak Detector The blood leak detector, which uses light absoption, includes the following components: • Housing with cover. • Transmitter board. • Receiver board. • Blood leak detector board. The transmitter and receiver boards are connected to the blood leak detector board. The blood leak detector board interfaces directly to the distribution board, via a board connector. 6:16 Technical description HC9286 Revision 10.2012 3. Pump Unit 3 (flow in) The fluid monitor contains three pump units. Each pump unit includes the following: • Gear wheel pump. • Pressure transducer with board. The pressure transducer is connected to the transducer board, via a twisted cable. The transducer board interfaces directly to the distribution board, via a board connector. • Output restrictor bypass valve, FOVA (flow output pump), evacuation valve, EVVA (flow input pump), DRVA (degassing pump). 4. Pump Unit 2 (flow out) see above 5. Pump Unit 1 (degassing) see above 6. Particle Filter 7. Degassing Chamber Both the degassing chamber and the deairating chamber have the function to separate air from the dialysis fluid. Each degassing- and deairating chamber contains a level detector. 8. Heating Vessel Unit The heating vessel unit contains the following: • Heating vessel. • 2 heating rods with over heating guard. • Temperature transducer (PT 100) with temperature transducer board. The PT 100 transducer is connected to the transducer board, via a twisted cable. The transducer board interfaces directly to the FM Analog Distribution board, via a board connector. • Float valve. • Water level guard. • Stirrer with 12 V DC-motor. • 2 pick-up tube detectors. 9. Bypass Unit The bypass unit includes the following: • Direct valve - DIVA. • Bypass valve - BYVA. • High Pressure Guard The high-pressure guard is a pressure transducer with a board. The pressure transducer is connected to the transducer board, via a twisted cable. The transducer board interfaces directly to the distribution board via a board connector. 10. Concentrate pick-up tube connections 11. High Pressure Guard HC9286 Revision 10.2012 Technical description 6:17 12. UF Measuring Unit The UF measuring unit consists of a measuring cell and two printed circuit boards. They are mounted on each side of the measuring cell. The UF measuring unit interfaces directly to the main board, via a flat cable. 13. Deairating Chamber Both the degassing chamber and the deairating chamber have the function to separate air from the dialysis fluid. Each degassing- and deairating chamber contains a level detector. The deairating chamber also contains a pressure transducer. The pressure transducer is used to measure the dialysis fluid pressure. The pressure transducer is connected to the transducer board, via a twisted cable. The transducer board interfaces directly to the distribution board, via a board connector. 14. Safety Bypass Unit The safety bypass unit includes the following: Safety pressure transducer with board. The pressure transducer is connected to the transducer board, via a twisted cable. The transducer board interfaces directly to the distribution board, via a board connector. 15. Infusion Port 16. Diascan With the use of a conductivity sensor, placed after the dialyzer in the fluid path, it is possible to measure clearance during treatment. The used method for estimation of urea clearance has been verified by urea clearance derived from blood samples during dialysis and has proved to provide comparable accuracy. 6:18 Technical description HC9286 Revision 10.2012 This page is intentionally left blank HC9286 Revision 10.2012 Technical description 6:19 6:20 Technical description HC9286 Revision 10.2012 1. Conductivity Cells 2. Level Detector 3. Control Pump 4. Protective Pump 5. Feeding Pump A The fluid monitor contains two feeding pumps. Each pump unit consists of a piston pump driven by a stepping motor. 6. Feeding Pump B The fluid monitor contains two feeding pumps. Each pump unit consists of a piston pump driven by a stepping motor. 7. Mixing Chamber Water and concentrate are mixed in the mixing chamber. 8. Top Priming Chamber 9. Heat exchanger The temperature of the incoming water is raised a couple of degrees in the heat exchanger. This reduces the power consumption of the heating elements. The heat exchanger is located on the back plate of the AK 200 ULTRA S dialysis machine. 10. Reducer Unit 11. Air Collect Chamber HC9286 Revision 10.2012 Technical description 6:21 6:22 Technical description HC9286 Revision 10.2012 1. Relay Unit 2. pH-sensor (optional) 3. BPM (optional) 4. Run Time Meter 5. Power Distribution Board 6. FM CPU Board 7. Blood Pressure Nipple 8. External connections See Installation Guide 9. Power supply 10. FM Fan Dialyzer Connections The input tube nipple is fitted with a particle filter. Water Inlet Unit The water inlet unit includes two valves: inlet valve - INVA - and flushing valve - FLVA. HC9286 Revision 10.2012 Technical description 6:23 FM valves 6:24 Technical description HC9286 Revision 10.2012 BCVA - BiCart® Valve Used during BiCart cartridge priming and top priming. BYVA - Bypass Valve Normally closed during treatment. Opens to let the fluid bypass the dialyzer in alarm situations. The BYVA is closed during the zero flow phase in the UF self-calibration and open during the differential flow phase. CWVA - Clean Water Valve In hemofiltration mode (HF mode) the clean water valve (CWVA) is always in bypass mode but for hemodialysis mode (HD mode) or hemodiafiltration mode (HDF mode) it may operate in both modes. The dialysis fluid is forwarded to the dialyzer via the output tube. DIVA - Direct Valve Normally open during treatment. Closes in alarm situations. Closed during UF-cell self-calibration. DRVA - Degass Resctriction Valve Open during heat disinfection to prevent the fluid system from boiling by bypassing the degassing restrictor. EMVA - Emptying Valve Three-way valve. Used to facilitate the emptying the blood leak detector. EVVA - Evacuation Valve Special three-way valve, only one of the house halves has a seat. From the functional point of view it works like an ordinary open/close valve. Opens when the level in the deairating chamber drops below its low limit to let out air from the chamber. FIVA - Filter Valve The filter valve (FIVA), closed during treatment, is used for disinfection of the second ultrafilter. FLVA - Flush Valve Open during disinfection for flushing the upper part of the heating vessel. FOVA - Flow Output bypass Valve Open during heat disinfection to prevent the fluid system from boiling by bypassing the flow out restrictor. HDVA - HD/HDF Valve INVA - Inlet Valve The inlet valve is normally open to let water into the heating vessel. It is closed in following situations: 1. If the water level in the heating vessel is too high. 2. In disinfection mode (except when the system is flushed). HC9286 Revision 10.2012 Technical description 6:25 LDVA - Level Detector Valve The level detector is used in the protective system for supervision of the SelectBag concentrate flow. PAVA - Priming A Valve Open during the priming of the SelectCart and the BiCart cartridges. PBVA- Proportion Bypass Valve Open in chemical disinfection when filling up. Opens during BiCart priming. Recirculation Valve Proportional valve (three-way valve) controlled by stepper motor. Part of the degassing level regulation. RFVA- Return Flush Valve Open during disinfection for recirculation of water. TAVA- Taration Valve The taration valve (TAVA) is normally open. During the UF measuring cell calibration, the taration valve is closed. TPVA- Top Priming Valve Used during top priming. ZEVA- Zeroing Valve The zero setting valve (ZEVA) is normally closed. During the UF measuring cell calibration phase 2, the zero setting valve is open. 6:26 Technical description HC9286 Revision 10.2012 Electrical circuit boards used in the fluid monitor For a detailed description how to connect all cables in AK 200 ULTRA S dialysis machine, see chapter 10, “Wiring diagram”: • Wiring Diagram FM 200 S, K20583 • Wiring Diagram BM 200 S, K20595 Following is a brief functional description of each board in the fluid monitor. FM CPU board The FM CPU board controls most functions in the fluid monitor of AK 200 ULTRA S dialysis machine. The CPU board consists of two major parts, the control system and the protective system. The main CPU in the control system is CPU F that controls I/O. The protective system consists of three Echelon nodes that communicate through the protective system Echelon bus. The FM CPU board is connected to the BM CPU board through the two Echelon buses and the safe bus. The safe bus is a current loop that if interrupted sets the machine in a patient safe state. The connection with the BM CPU board is done through the Power Distribution Board FM. Inputs and outputs P1 is a 60 pin connector connected to the Analog Distribution Board. Input signals from temperature transducers, conductivity cells, pressure transducers and blood leak detector. Output signals to blood leak detector and I2C-EEPROMs. Power: +5, +12, -12 and +24 V. P2 is a 40 pin connector connected to I/O. Input signals from pH transducer, water vessel low level detector and tube sense A and B. Output signals to I2C-EEPROM:s, valves, degassing motor, restrictor stepper motor and stirring motor. Power: +5 and +24 V. P3 is a 50 pin connector connected to I/O. Input signals from heaters off detector and BiCart latch status detector. Output signals to valves, conductivity 1 and 2 stepper motor, flow motor in and out and heaters. Power: +24V. P4 is a 20 pin connector connected to the UFM Preamplifier Board. Input signals: preamplified UF-measure signals. Output signals: UFFQ (UF frequency) and signals to an I2C-EEPROM. Power: +5, +12, -12 and +24 V. P5 is a 10 pin connector connected to I/O. Input signal from Bicart trap low level detector. Output signals to valves. Power: + 24 V. P6 is a 40 pin connector connected to Select units. Input signals from control and supervision pump synchronization detectors, supervision level detector, SelectCart cartridge latch status detector and SelectBag container position detector. Output signals to control and supervision pumps, supervision level detector and valves. Power: +5 V and +24 V. HC9286 Revision 10.2012 Technical description 6:27 P7 is a 4 pin connector connected to the I2C-EEPROM at the run time meter. Signals: CAD0 and CAC0. Power: +5 V. P8 is a 2 pin power connector connected to the Power Distribution Board FM. +24 V is supplied in this connector. P9 is a 20 pin connector connected to the Power Distribution Board FM. Input signals from an external RS232 interface and from the Blood Pressure Monitor, BPM. Output signals to the external RS232 interface, to the BPM and to the FM fan. Bi-directional signals are the Echelon bus signals CEDA, CEDB, PEDA and PEDB and SBSI that connects the safe bus between FM and BM. Power: +5 V. P10 is a 10 pin expansion connector for the protective Echelon bus. Signals: PEDA and PEDB. Power: +5, +12 and -12 V. P11 is a 10 pin expansion connector for the control Echelon bus. Signals: CEDA and CEDB. Power: +5, +12 and -12 V. P12 is a 4 pin optional I/O connector. TIN1 and TIN2 are input signals. Power: +5V. P13 is a 10 pin analog test connector used in production. Five analog signals are connected to this connector. P14 is a 2 pin connector connected to the deairating ultrasonic level transducer. P15 is a 2 pin connector connected to the degas ultrasonic level transducer. P16 is a 4 pin optional +24 V output connector. P17 is a 20 pin connector for protective node Q used for emulation. The reset and the service pin of the neuron chip are connected to P17 together with the 11 I/O pins. Power: +5 V. P18 is a 20 pin JTAG test connector. Signals are the five JTAG test signals connected to the FPGA and 8 further signals that can be used for test of the FPGA. Power: +5V. P19 is a 20 pin connector for the Select supervision node used for emulation. The reset and the service pin of the neuron chip are connected to P19 together with the 11 I/O pins. Power: +5 V. P20 is a 20 pin connector for the control communication node used for emulation. The reset and the service pin of the neuron chip are connected to P20 together with the 11 I/O pins. Power: +5 V. P21 is a 20 pin connector for the protective flow restrictor node used for emulation. The reset and the service pin of the neuron chip are connected to P21 together with the 11 I/O pins. Power: +5 V. P22 is a 20 pin connector for the Select control node used for emulation. The reset and the service pin of the neuron chip are connected to P22 together with the 11 I/O pins. Power: +5 V. 6:28 Technical description HC9286 Revision 10.2012 Jumpers on the FM CPU board J1 Short-circuiting causes the protective node Q to send a service message J2 Short-circuiting resets the protective node Q J3 The jumper, connected to the FPGA, can be used for test purpose J4 Short-circuiting resets the Select supervision node J5 Short-circuiting resets the control communication node J6 Short-circuiting causes the control communication node to send a service message J7 Short-circuiting causes the Select supervision node to send a service message J8 Short-circuiting resets the protective flow restrictor node J9 Sets CPU F, OB and P in boot load mode ready to receive new software J10 Short-circuiting resets the Select control node J11 Short-circuiting causes the Select control node to send a service message J12 Short-circuiting causes the protective flow restrictor node to send a service message HC9286 Revision 10.2012 Technical description 6:29 FM Analog Distribution board This board is localized in the AK 200 ULTRA S fluid monitor, where its function is to gather all the sensor signals to one cable that is connected to the main FM CPU board. The devices that are connected on this board are: • Conductivity cells • All fluid pressure sensors • Blood leak detector • Temperature sensors • Dia connector sensors • Return flow valve – RFVA • Feeding Pumps • Conductivity Measuring Unit • Water Inlet Unit • Top Priming Unit The distribution board contains 13 board connectors, which are used to interface the transducer boards. Three of the connectors are normally not used. The temperature/pressure transducer and the transducer board must not be separated. If the transducer is to be replaced, the transducer board must also be replaced (and vice versa). It is important that the transducer boards are connected to the correct distribution board connector. For example, board connector P22 must not be used for any other transducer board than the dialysis fluid pressure transducer board. FM Power Distribution board The FM Power Distribution Board distributes power from the AC/DC unit to the fluid monitor and the blood monitor in AK 200 ULTRA S dialysis machine and contains control logic for four external interfaces. It connects the control system Echelon bus, the protective system Echelon bus and the safe bus between the FM CPU board and the BM CPU board. It also connects the Blood Pressure Monitor (BPM) to the FM CPU board, supplies operating voltage to the running-time meter and distributes signals to the FM fan. Blood leak Detector board The blood leak detector board is localized in the AK 200 ULTRA S fluid monitor where it is a part of the blood leak detector. This detector measures the optical transmission with a LED and a photo transistor. The LED current is controlled with this PCB and the measured photo transistor current is converted to a voltage. Calibration values for the detector are also stored on the board. 6:30 Technical description HC9286 Revision 10.2012 Conductivity cell board This board is used to measure the conductivity of the dialysis fluid. It is designed with two equally, completely separate, circuits in order to support the requirement of one control and one protective system measurement. The conductivity cell board also includes electronic for PT100 temperature sensors that are used for temperature compensation of the conductivity measurement. Blood pressure monitor board The blood pressure monitor board is used in AK 200 ULTRA S dialysis machine when an optional blood pressure monitor (BPM) is connected. It is designed to supply the BPM with needed power supply. The Blood pressure monitor board is located between the power distribution board and the BPM module. HC9286 Revision 10.2012 Technical description 6:31 Blood Monitor, BM 6:32 Technical description HC9286 Revision 10.2012 Treatment Double Needle Treatment - HD Following figure illustrates the flow diagram when the AK 200 ULTRA S dialysis machine is used for double needle treatment. Figure 6:11 Simplified Flow Diagram - Double Needle Treatment The function of the arterial blood pump is to maintain the extra corporeal blood flow. Blood is removed from the patient, forwarded to the dialyzer and then returned to the patient. The blood flow (0 - 500 ml/min) is set by means of a knob on the operator’s panel. In an alarm situation the blood pump is stopped. The blood pump will not operate when the pump cover is open. In an alarm situation, the blood can be returned to the patient manually. The blood pump has a handle that can be pulled out and turned to return the blood. The arterial line clamp is open during normal treatment. When an alarm is issued by the air detector or the blood leak detector (in the fluid monitor) the clamp closes and the blood pump is stopped. The arterial pressure transducer will issue an alarm if the pressure becomes to low. For example, if the needle or arterial blood line is blocked, an alarm will be given (the blood pump is stopped). The alarm is activated if there is an increased negative pressure between the patient and the blood pump, e.g. a fall in blood pressure, altered positions of the arterial needle, or a kink in the arterial line between the patient and the blood pump. The heparin pump is used for injection of heparin to the blood in order to inhibit coagulation. An alarm is issued when the syringe reaches end of stroke or if the heparin line is kinked. HC9286 Revision 10.2012 Technical description 6:33 The blood passes the Blood Volume Sensor before it enters the dialyzer. The BVS gives additional information about the patient’s hydration status to the operator, by providing information about the change in the apparent blood volume. After the dialyzer there is a drip chamber with an air detector. If air is detected in the blood or if the blood level in the drip chamber is too low, an alarm is issued and the blood flow is stopped (the blood and heparin pumps are stopped and the line clamps are closed). The drip chamber acts as an expansion chamber to even out pressure pulsation. The level in the drip chamber is adjustable by means of a venous level adjustment (the button on the front panel that is located to the left of the venous line clamp). The venous pressure transducer measures the venous blood pressure. If the pressure is too low or too high, the blood flow is stopped (the blood and heparin pumps are stopped and the line clamps are closed). Too high venous pressure may be caused by an obstruction after the venous drip chamber or a change in the patient’s position. If the venous pressure is too low, it could be caused by a line separation, an obstruction before the venous drip chamber, a fall in blood pressure or a change in the patient’s position. The priming detector detects if there is blood in the venous blood line. The blood is returned to the patient via the venous line clamp. The clamp is normally open. But in the event of an alarm from the air detector, the venous pressure transducer or the blood leak detector (in the fluid monitor), the line clamp clamps the blood line and stops the blood flow. Single Needle Treatment Single Pump Following figures illustrate the flow diagrams when the AK 200 ULTRA S dialysis machine is used for single needle treatment. Figure 6:12 Pump Simplified Flow Diagrams - Single Needle Treatment - Single When the AK 200 ULTRA S dialysis machine is used for single needle-single pump treatment, the arterial and venous phases are timeor pressure controlled. 6:34 Technical description HC9286 Revision 10.2012 Arterial blood is removed from the patient when the arterial line clamp is open and the venous line clamp is closed. The running time of the arterial blood pump is determined by the operator. In this way a positive pressure is created. In the next phase, the blood pump is stopped, the arterial line clamp is closed and the venous line clamp is opened, i.e. the blood is returned to the patient by means of the positive pressure. The venous line clamp is then closed, the arterial line clamp is opened, the blood pump is started and the procedure repeated. In single needle mode, the operator defines the length of time the arterial and venous line clamps are to be open and closed. The expansion chamber evens out pressure pulsation. The blood level in the expansion chamber is electrically adjustable from front panel. Double Pump Figure 6:13 Pump Simplified Flow Diagrams - Single Needle Treatment - Double When the blood monitor is used for single needle treatment, both blood pumps are used. Note that the pumps are running in divergent directions. The treatment is controlled by a predefined stroke volume, mean blood flow and by the high limit on the system pressure transducer (extra). The required mean blood flow and stroke volume is determined by the operator. When the mean blood flow is affected, the venous and arterial blood pump will change its speed. The venous pump is volume controlled. The mean blood flow is set in the same way as the required blood flow in the double needle treatment. When the SN button is pressed, the arterial blood pump will start and will run until the expansion chamber is filled up (detected by the high limit on the system pressure transducer). The venous blood pump then will start, and will run until the predefined stroke volume has been returned to the patient. This is monitored by the low limit on the system pressure transducer after the filter. The process is repeated throughout treatment. Since the two blood pumps run alternately, the drip chamber acts as an expansion chamber to even out pressure pulsation. The standard configuration includes three pressure transducers: arterial pressure transducer, venous pressure transducer and system pressure transducer. HC9286 Revision 10.2012 Technical description 6:35 Double Needle Treatment Figure 6:14 Simplified Flow Diagram - Double Needle treatment - post dilution Figure 6:15 pre dilution Simplified Flow Diagram - Double Needle treatment - HDF Low Volume The BM 202 offers the possibility to perform low volume HDF in double needle mode by using the venous pump for infusion. Maximum infusion rate is 2.0 l/h. Note • This mode can only be used if the AK 200 ULTRA S dialysis machine is used in an non-online mode. See AK 200 ULTRA S Operator’s Manual for further information. Note HDF on line These simplified figures shows how the AK 200 ULTRA S dialysis machine is used for HDF on-line treatment. The venous pump operates as infusion pump, taking infusion fluid from the infusion port on the FM, pumping it through an ultrafilter, into either the venous line (post-dilution), or the arterial line (pre-dilution). See AK 200 ULTRA S Operator’s manual for further information. 6:36 Technical description HC9286 Revision 10.2012 HF on line When AK 200 ULTRA S dialysis machine works in HF on-line mode, the setup for the lines are the same as for HDF, either pre- or post dilution can be used. See AK 200 ULTRA S Operator’s manual for further information. HC9286 Revision 10.2012 Technical description 6:37 Design and Construction Level Detector (Air detector) The level detector consists of an ultrasonic transmitter and receiver mounted in one unit. The transmitter is mounted on the right-hand side of the drip chamber and the receiver is mounted on the left-hand side. Bubbles larger than 1 μl will be trapped by the drip chamber. An alarm will be issued if the blood level falls below the middle of the level detector head. Batteries A 9-volt battery, used to drive buzzer alarm during mains power failure, is mounted inside the blood monitor. The battery is connected after installation. A lithium battery, mounted on the main board, is used to run the real time clock in BM 202. WARNING Lithium battery - danger of explosion! When replacing the battery, use the same type (recommended by Gambro service representative). WARNING Blood Pump Unit The BM 202 includes two blood pump units (arterial and venous blood pumps). The blood pump unit consists of the following: • Roller pumps (self-threading). • 24 V brush less DC motor with an encoder for velocity monitoring. • Gear box (1:50). • Cover detector. • Blood pump rotation detector. BVS - Blood Volume Sensor The BVS on the front panel is a passive measurement device. It continuously measures the hemoglobin concentration of blood in the extracorporeal circuit and calculates the relative change in the patient’s blood volume during a dialysis session. The BVS includes a sensor with optical components for transmitting light through the cuvette in the blood line. The BVS board has analog transmit- and receiveelectronics for the optical components and digital electronics for data acquisition, calculations and communication with the main system. The BVS board is connected direct to the Panel board, P2. 6:38 Technical description HC9286 Revision 10.2012 Drip Chamber Level Adjustment Two different drip chamber levels can be adjusted. The level in the venous drip chamber is electrical adjusted by pressing the level adjustment buttons on the front panel. The level in the venous drip chamber is adjusted by pressing ↑or ↓ in the right (blue) area. The level in the expansion chamber connected to the system pressure transducer connector may be adjusted by pressing ↑or ↓ in the left (gray) area. Fan The drive motor (24 V DC-motor) and the fan form a single unit. Heparin Pump Unit The heparin pump unit consists of the following components: • Syringe holder. • Stepping motor. • Gear box (1:120). • Heparin pump position board. • Heparin pump position potentiometer. • Load-limiting device. Line Clamp Unit The blood monitor includes two line clamps, arterial line clamp and venous line clamp. The arterial line clamp is located to the right and the venous line clamp is located to the left when viewed from the front. The clamp covers also have different colour markings: the arterial clamp cover is marked with a red dot and the venous clamp cover is marked with a blue dot. The line clamp unit consists of the following: • Housing with covers (mounted on the front). • Two solenoids (as one unit). • Line clamp driver board (clamp driver circuit on BM CPU board). • Two clamp position detectors (on the clamp driver board). Operator's Panel The operator’s panel user interface in AK 200 ULTRA S dialysis machine consists of 45 buttons, 62 LED assemblies and flow indicators, 2 rotary encoders, 8 bar graphs and a 3 x 7 segment LED display. HC9286 Revision 10.2012 Technical description 6:39 Pressure Transducers There are three different Pressure Transducers: • Venous Pressure Transducer • System Pressure Transducer • Arterial Pressure Transducer BM 202 is equipped with a pressure transducer, Venous Pressure Transducer, which is used to measure the venous blood pressure. This is located on a transducer board, which interfaces directly to BM Analog Distribution board, via a board connector. The pressure transducer is connected to the venous pressure transducer nipple (located on the front panel to the right of the air detector), via a tube and to the level adjustment device. The BM 202 is equipped with a second pressure transducer after the filter, named System Pressure Transducer. This pressure will only be displayed if the SN data button is depressed. The transducer is mounted on a transducer board, which also interfaces directly to the BM Analog Distribution board, via a board connector. The BM 202 is equipped with a third pressure transducer, named Arterial Pressure Transducer. This pressure will be displayed on the arterial bargraph. The transducer is used for true arterial pressure measurement or any other pressure. The pressure transducer is mounted on a pressure transducer board, which interfaces to the BM Analog Distribution board, via a board connector. Priming Detector The priming detector is integrated in the Line Clamp Unit. It has a detector board (on the back of the front). The detector board contains an LED and a photo transistor. The current through the LED is indicating how much current that is needed to get a certain light transmission through the light guides to the receiver. The lower the value is the better. BPM - Blood Pressure Monitor The BPM (Blood pressure monitor) is physically placed on the back of the AK 200 ULTRA S dialysis machine, behind the FM board. The BPM monitor is a passive measuring device that can issue attentions and alarms but the alarms will not interfere with the AK 200 ULTRA S dialysis treatment. The intended use for the BPM is to measure the patient’s blood pressure and to activate an alarm if the patient’s blood pressure goes under an alarm limit set by the operator. This will give the nurses the possibility to take measures before the patient suffers the ill effects of hypotension (low blood pressure). 6:40 Technical description HC9286 Revision 10.2012 The BPM module includes the following components; air pump, bleed valve, dump valve, two pressure transducers (control and protective) and microprocessor board. The module includes control and protective systems. The control system measures the pressure and pulse wave to calculate the systolic, diastolic, mean blood pressure and pulse rate. The air pump, dump and bleed valves are controlled by this system as well as external communication. The protective system supervises the maximum pressure and inflating time by using an separate pressure transducer. Maximum pressure is 320 ±10 mmHg and maximum inflating time is 180 seconds. When these values exceed specified limits, dump and bleed valves are opened and air pump is stopped by the protective system. A self-calibration/auto zero function is included in the module, which means that the offset for the pressure transducers is calibrated/adjusted each time the module is turned on. The BPM measures and calculates the non-invasive blood pressure by using the oscillometric method. This method uses the pulsation that occurs in the artery in the arm when it is restricted by the inflated cuff. The noise or oscillation originates from the fact that when the cuff restricts the vessel, the flow in the vessel becomes turbulent, instead of laminar. The pulsation causes the pressure in the cuff to oscillate which the pressure transducer in the BPM module measures. The relationship between the changes of cuff pressure and its oscillation is used to determine the blood pressure. When the BPM deflates the cuff and the blood starts to pass the restriction, the oscillation incline rapidly and the systolic (high) pressure is measured. When the oscillation has peaked and is declining rapidly the diastolic (low) pressure is measured. The mean pressure is measured when the oscillation is peaking. The heart rate is determined by using the pressure oscillations measured by the pressure transducer. When to measure the diastolic pressure is determined by extensive experiments to establish an algorithm, which is included in the BPM software. In the field it is possible to perform a check of the device to determine if it works or not. The device has to be sent to Gambro for repair incase of malfunction. HC9286 Revision 10.2012 Technical description 6:41 Electrical circuit boards used in the blood monitor For a detailed description how to connect all cables in AK 200 ULTRA S dialysis machine, see the attached drawing: • Wiring Diagram FM 200 S, K20583 • Wiring Diagram BM 200 S, K20595 Following is a brief functional description of each board in the blood monitor. BM Analog Distribution Board This board is localized in the AK 200 ULTRA S blood monitor, where its functions is to gather all the sensor and motor signals to one cable that is connected to the main BM CPU board. The devices that are connected on this board are: • Arterial and Venous blood pump cover and position detectors • Heparin position, potentiometer and motor • Priming and tube detector • Level detector transmitter • Arterial, venous and system pressure • Motor A for pressure test • One auxiliary contact Jumpers on the BM Analog Distribution Board 6:42 J4 Termination of EPRP an EPRN when system pressure is not mounted J5 Termination of EPRP an EPRN when system pressure is not mounted J6 Termination of BPVC/ in case of single pump Technical description HC9286 Revision 10.2012 Panel Control Board The operator’s panel user interface in AK 200 ULTRA S dialysis machine consists of 45 buttons, 62 LED assemblies and flow indicators, 3 rotary encoders (whereof 2 is used), 8 bar graphs and a 3 x 7 segment LED display. The handling was previously placed in AK 200 ULTRA S dialysis machine on the BM CPU board. To free up more physical space and to minimize the cables between the BM CPU board and the panel, this functionality is moved to a PCB placed directly beneath the operator’s panel. The PCB is called the Panel control board. Jumpers on the Panel Control Board J1, Echelon bus termination 1-2 Termination of CEDA-B bus open No termination J2, Service control 1-2 Service pin for micro controller (Service message will be sent from the micro controller on the echelon bus) open Normal J3, Reset 1-2 Reset open Normal, reset only possible with IC2 or through command on the echelon bus HC9286 Revision 10.2012 Technical description 6:43 BM CPU Board The BM CPU board controls the blood parts of AK 200 ULTRA S dialysis machine and can easily be pulled upwards and fixed in the service position. The board consists of two major parts, control system and protective system. The board handles I/O such as heparin pump, blood pumps, priming and level detector, clamps and fan. The BM CPU board is connected through communication with the FM CPU board and Panel control board. The LCD display is connected to the BM CPU board. Pressures are measured from external sensors. Jumpers on the BM CPU board J2 When closed the protective system is forced into boot mode J3 When closed protective system communication node will reset J4 When closed protective system communication node will be forced into service state J5 Not used. Connected to protective FPGA J6 To select RS 232 port on FM Power Distribution Board J7 When closed the control system is forced into boot mode. J8 When closed control system communication node will reset J9 When closed control system communication node will be forced into service state J10 When closed the blood pump voltage (R24V) and the pressure test voltage (PT24V) will be on disregarding status of protective system and the safe bus J11 When closed the battery connected to P51 is charged Inputs and outputs: 6:44 Technical description HC9286 Revision 10.2012 Connectors on the BM CPU Board Connector Name Description P51 Battery 9 V battery back-up for power control logic P55 Test Prot. Comm. Test connector for protective communication P56 Tacho BPA Tacho input for arterial blood pump P57 Motor BPA Motor output for arterial blood pump P58 Test Prot. FPGA Test connector from protective FPGA P59 Expansion Prot. sys Expansion from protective communication P60 Operator's panel Connector to operator's panel P61 Level detector Input from level detector interface P62 BM I/O Connector to BM I/O interface P63 24 V Z24P/Z0VP voltage supply P64 Test Contr. FPGA Test connector from control FPGA P65 Level control Output for level adjustment pump P66 Fan Output to the fan P67 Clamp Connector to clamp interface P68 Tacho BPV Tacho input for venous blood pump P69 Motor BPV Motor output for venous blood pump P70 Test Contr. Comm. Test connector for control communication P71 24 V Supply Input for 24 V DC supply voltage P72 FM Power dist. Input and outputs towards power distribution board P73 Back light Supply voltage for back light inverter on display P74 Level adjustment Input for level adjustment keys P75 LVDS LVDS output interface for display P76 Parallel interface Parallel interface from protective FPGA HC9286 Revision 10.2012 Technical description 6:45 Power Supply Figure 6:17 Power supply 1. DC to the Power distribution board, P65 2. AC to the heating rods 3. Mains cable connector 4. Safety latch for the mains cable 6:46 Technical description HC9286 Revision 10.2012 Mains Voltage Frequency Power Consumption Cable: Connector: Mains plug: Earth Leakage Current Patient Leakage Current Fuses 115 or 230 V AC (±10%) 50 or 60 Hz (±5 Hz) Max. 2250 W at 230 V Max. 1650 W at 115 V 3 conductor cable, Length max. 3 m rating 250 V 10 A Certified to IEC 320/C13. 250 V AC / 10 -16 A, approved or Hospital grade, with protective earth, 125 V AC / 15 A, approved. max 500 μA max 100 μA 2 x T 10 A All leakage currents are specified without external equipment connected to the machine. Mains voltage is fed to an AC/DC converter. The AC/DC converter supplies the DC/DC units in the fluid monitor and in the blood monitor respectively with supply voltage (+24 V). A mains transformer and a stabilizer provide the power control logic in the blood monitor with necessary supply voltage (+12 V). The power supply also supplies the heater rods in the fluid monitor with their supply voltage (mains). If the power supply is of 115 V type, the heater rods must be supplied from the mains directly. Consequently, in this case two mains cables are required: one is connected between the power unit and the power supply and one is connected between the power unit and the fluid monitor. In a mains power failure situation, the AK 200 S / AK 200 ULTRA S dialysis machine gives an intermittent buzzer alarm and is disconnected from the +24 V supply by means of signal REMO. Signal REMO is obtained from the power control logic in the blood monitor. HC9286 Revision 10.2012 Technical description 6:47 Monitor stand The height of the monitor stand can be adjusted either electrically (MS 202) or in five fixed positions (MS 200). Figure 6:18 positions 6:48 MS 202 electrically adjustable / MS 200 Five fixed Technical description HC9286 Revision 10.2012 1. Infusion pole The maximum allowed load is 10 kg. 2. Height adjustment for infusion pole 3. Rear handle 4. Bars, lifting positions Positions where the AK 200 S / AK 200 ULTRA S dialysis machine is safely lifted, both on the right and left hand side of the machine. 5. Screws For locking the handle (service frame). 6. Control for height adjustment For MS 202 only 7. Power supply cord For MS 202 only 8. Tray for concentrate containers 9. Lockable wheels The wheels must be locked during treatment. During internal transportation the AK 200 S / AK 200 ULTRA S dialysis machine must be in upright position. 10. Screws (rear side) For MS 200 only. HC9286 Revision 10.2012 Technical description 6:49 This page is intentionally left blank 6:50 Technical description HC9286 Revision 10.2012 Chapter 7 Technical data and specifications AK 200™ S dialysis machine Contents Performance and specification - Control System . . . . . . . . . . . . . . . . . Blood Flow Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Air Detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Heparin Administration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Blood Volume Sensor (BVS) . . . . . . . . . . . . . . . . . . . . . . . . . . Blood Pressure Monitor (BPM) . . . . . . . . . . . . . . . . . . . . . . . . Dialysis fluid preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Dialysis fluid preparation (BiCart SelectⓇ concentrate system mode only) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Ultrafiltration control (Volume control) . . . . . . . . . . . . . . . . . . . Profiling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . DiascanⓇ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Disinfection and Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . Water supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Drain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Power supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Connection of external equipment . . . . . . . . . . . . . . . . . . . . . . Battery Back-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Performance and specification - Supervisory system . . . . . . . . . . . . . . Blood Pressure Supervision . . . . . . . . . . . . . . . . . . . . . . . . . . . Air Detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Heparin Administration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Dialysis fluid preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Dialysis fluid preparation (BiCart SelectⓇ concentrate system mode only) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Ultrafiltration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Blood leak detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Blood loss due to coagulation . . . . . . . . . . . . . . . . . . . . . . . . . . Physical data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Materials in contact with water, concentrates and dialysis fluid . . . . . . Polymers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Metals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Others . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Environmental data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Transportation and storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . Energy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Electromagnetic environment . . . . . . . . . . . . . . . . . . . . . . . . . . Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . HCEN9287 Revision 10.2012 Tech. data and specifications - AK 200™ S dialysis machine 7:2 7:2 7:3 7:3 7:3 7:4 7:5 7:6 7:6 7:6 7:7 7:8 7:11 7:12 7:12 7:12 7:14 7:15 7:15 7:16 7:16 7:16 7:16 7:17 7:17 7:17 7:18 7:18 7:19 7:19 7:19 7:19 7:20 7:20 7:20 7:20 7:21 7:25 7:1 Performance and specification - Control System Note • When accuracy ranges are written as e.g. “(±1 ml/min or ±1%)” the widest range is valid. • For the qualified technician, the Service Manual for the AK 200 S dialysis machine is available. The Service Manual provides all the necessary information for the safe and required maintenance of the machine. Note Blood Flow Control Values for the blood pump(s) are based on the arterial blood pump with a pump segment of 7.9 mm and 2.0 mm wall thickness. For paediatric blood tubes with pump segment of 4.0 mm it is also possible to set blood flow to 10 or 15 ml/min. Accuracy is then ±5 ml/min. Double Needle Blood Flows in HD, single pump: Accumulated blood volume: 20 to 500 ml/min (±10 ml/min or ±15%) 0 to 327 litres (±0.6 l * treatment time (h) or ±15%) Single Needle Single Pump Arterial flow: Time control: Pressure control: Accumulated blood volume: 20 to 500 ml/min (±10 ml/min or ±18%) 2 to 20 sec (±1 sec), Arterial and venous time. The actual clamp opening time is depending on blood flow rate, size of expansion chamber and pressure limits. 10 to 600 mmHg (±50 mmHg), venous pressure control 0 to 327 litres (±0.6 l * treatment time (h) or ±18%) Single Needle Double Pump (HD only) Double pump-A Double pump-V Mean Flow-SN/DP Accumulated blood volume Stroke Volume-SN/DP 7:2 20 to 800 ml/min 20 to 800 ml/min 10 to 400 ml/min (±10 ml or ±15%) 0 to 99.9 litres (±0.6 l * treatment time (h) or ±15%) 2 to 60 ml/stroke (±15%) at a cycle time < 20 s Tech. data and specifications - AK 200™ S dialysis machine HCEN9287 Revision 10.2012 Air Detection Sensitivity Venous drip chamber size (diameter) Bubbles larger than 1 μl will be trapped by the drip chamber. An alarm will be issued if the blood level falls below the middle of the air detector. 22 mm Heparin Administration Heparinization 0/0.5 to 10 ml/h (±1 ml or 0.2 ml * heparinization time (h) or ±5%) 0 to 4.00 h.min (±1 min) (20 min) Stop time, can be preset (Default) Syringe size, can be preset 10 to 30 ml (30 ml) (Default) Maximum counter pressure +650 mmHg The accuracy is based on tests with 20 ml and 30 ml syringes Blood Volume Sensor (BVS) Relative blood volume ∆BV HCEN9287 Revision 10.2012 - 40% to + 10% from reference value (Standard deviation ±3%) Sensor active for Hb ≥ 80 g/l and blood flow ≥180 ml/min Tech. data and specifications - AK 200™ S dialysis machine 7:3 Blood Pressure Monitor (BPM) The alarm limits below can be preset. The value put in brackets and in italics is the default value. Systolic pressure range1,2 Low alarm limit, can be preset (Default) High alarm limit, can be preset (Default) Diastolic pressure range1,2 Low alarm limit, can be preset (Default) High alarm limit, can be preset (Default) Mean pressure range1,2 Low alarm limit, can be preset (Default) High alarm limit, can be preset (Default) 40 - 260 mmHg 60 - 250 mmHg (100 mmHg) 60 - 250 mmHg (180 mmHg) 20 - 200 mmHg 40 - 200 mmHg (40 mmHg) 40 - 200 mmHg (110 mmHg) 26 - 220 mmHg 45 - 235 mmHg (45 mmHg) 45 - 235 mmHg (235 mmHg) Rated cuff pressure range2 120 - 280 mmHg Pulse rate range 2 30 - 220 bpm (±2 bpm or ±2 % of reading) 40 - 180 bpm (40 bpm) Low alarm limit, can be preset (Default) High alarm limit, can be preset (Default) 40 - 180 bpm (130 bpm) 1 Meets ANSI/AAMI SP-10 (1992). Mean error ±5 mmHg. Standard deviation 8 mmHg 2 The rated range is valid for the blood pressure monitor Suntech firmware version 3.41 or higher. 7:4 Tech. data and specifications - AK 200™ S dialysis machine HCEN9287 Revision 10.2012 Dialysis fluid preparation Temperature Dialysis Fluid Temperature 33-40 °C (+0.5/-1.5 °C) (+0.5/-2.7 °C) with UFD-kit at fluid flow < 500 ml/min. Temperature low alarm, can 31 to 41 °C (35°) be preset (Default) Temperature high alarm, 31 to 41 °C (39°) can be preset (Default) Fluid flow Dialysis Fluid Flow Rate 300 to 700 ml/min (±10 ml/min) Conductivity Conductivity measuring Alarm limits in Acetate mode Alarm limit in Bicarbonate mode, A-step (acidic) Alarm Limit in Bicarbonate mode, B-step (bicarbonate) 0.1 - 20 mS/cm (±0.1 mS/cm) ±5 % of set value ±5% of set value for A-step conductivity ±5% of set value for B-step conductivity Alarm limits are extended to 10% for maximum 2 minutes of 10 minutes Concentration Na+, Acetate mode Na+, Bicarbonate mode HCO3-, Bicarbonate mode 115 to 160 mmol/l (±4 mmol/l) 130 to 150 mmol/l (±6 mmol/l) 20 to 40 mmol/l (±6 mmol/l) Concentrates Max. pressure for concentrates +50 kPa pH supervision pH measurement of Dialysis Fluid 1 to 9.9 pH units (±0.2 pH units for pH 5 to 9, ±0.5 pH units for pH<5 or pH>9) pH low alarm, can be preset 1 to 15 pH units (6 Acetate mode, 6.5 (Default) Bicarb mode) pH high alarm, can be 1 to 15 pH units (8 Acetate mode, 7.8 preset (Default) Bicarb mode) HCEN9287 Revision 10.2012 Tech. data and specifications - AK 200™ S dialysis machine 7:5 Degassing Degassing pressure in Acetate mode, can be preset (Default) Degassing pressure in Bicarbonate mode, can be preset (Default) -700 to -500 mmHg (±30 mmHg) (-630 mmHg) Minimum 75 mmHg absolute pressure -700 to -500 mmHg (±30 mmHg) (-580 mmHg) Minimum 75 mmHg absolute pressure Dialysis fluid preparation (BiCart SelectⓇ concentrate system mode only) Fluid flow 1 L SelectBag concentrate Proportioning Ratio 1:200 (±3%) 1 L SelectBag concentrate Proportioning Ratio is defined as the quotient 1 L SelectBag concentrate flow/dialysis fluid flow Ultrafiltration control (Volume control) UF volume UF-rate Treatment Time max. 30 litres (±50 ml or ±50 ml * passed treatment time (h) or ±2.5%) 0.0 to 4.0 l/h 0.05 to 9.59 hour.minute (±1 minute) Profiling UF-rate Na+, Acetate mode Na+, Bicarbonate mode HCO3-, Bicarbonate mode 0 to 4 l/h 115 to 160 mmol/l 130 to 150 mmol/l 20 to 40 mmol/l Half-times: Degressive Progressive 7:6 Set in h.min, 10 to 25% of remaining treatment time Set in h.min, 75 to 90% of remaining treatment time Tech. data and specifications - AK 200™ S dialysis machine HCEN9287 Revision 10.2012 DiascanⓇ Accuracy is valid in HD mode double needle treatment, for blood flows 200 to 500 ml/min and fluid flows 500 to 700 ml/min, UF profiling is allowed. Clearance, K Cumulated water volume cleared of urea, Kt Dialysis dose, Kt/V Plasma sodium, Na+ HCEN9287 Revision 10.2012 0 to 350 ml/min (±10%) 0 to 100 l (±10%) 0 to 3 (±10%) 130 to 160 mmol/l Tech. data and specifications - AK 200™ S dialysis machine 7:7 Disinfection and Cleaning Temperature and time in different phases and concentration of disinfectant are possible to preset. The values in this specification are the default values and what the machine has been validated against. Follow the instructions from the manufacturer of the disinfectant, to set the correct dilution and dwell time. All disinfection programs in the AK 200 S dialysis machine are tested in accordance with the French standard NFS 90-304 and established to fulfil the requirements expressed in the same standard. Time for disinfection programs is estimated and may vary. All values below are applicable for the 230V AC variant. For the 115V AC variant add 5 minutes to all heating programs. For the 115V AC S UFD variant add 7 minutes to all heating programs. Heat disinfection Program Temperature Fill up phase Circulation phase Drain phase Total time 93 °C 10 minutes (13 minutes with UFD-kit, (optional)) 15 minutes 4 minutes 29 minutes (32 minutes with UFD-kit, (optional)) Heat disinfection Program with CleanCart Ⓡ cartridge Decalcification Cleaning Temperature Fill up and mixing phase Circulation phase Rinse/Drain phase Total time 7:8 CleanCart C CleanCart A 93 °C 12 minutes (13 minutes with UFD-kit, (optional)) 15 minutes 5 minutes (11 minutes with UFD-kit, (optional)) 32 minutes (39 minutes with UFD-kit, (optional)) Tech. data and specifications - AK 200™ S dialysis machine HCEN9287 Revision 10.2012 Heat disinfection Program with liquid citric acid Temperature Concentration Concentration in machine Consumption Fill up and mixing phase Circulation phase Rinse/Drain phase Total time 93 °C 20 % citric acid 2 % citric acid; i.e. diluted 1 + 9 Approx. 200 ml (Approx. 230 ml with UFD-kit, (optional)) 15 minutes (18 minutes with UFD-kit, (optional)) 15 minutes 10 minutes 40 minutes (43 minutes with UFD-kit, (optional)) Heat disinfection Program with WRO 300 H Temperature Fill up phase Circulation phase Low flow heat phase Drain phase Total time 93 °C 10 minutes (13 minutes with UFD-kit, (optional)) 15 minutes 20 minutes 4 minutes 49 minutes (52 minutes with UFD-kit, (optional)) Heat disinfection Program with CleanCartⓇ cartridge including WRO 300 H Decalcification Cleaning Temperature Fill up phase Circulation phase Low flow heat phase Rinse/Drain phase Total time HCEN9287 Revision 10.2012 CleanCart C CleanCart A 93 °C 10 minutes (13 minutes with UFD-kit, (optional)) 15 minutes 20 minutes 4 minutes (11 minutes with UFD-kit, (optional)) 49 minutes (59 minutes with UFD-kit, (optional)) Tech. data and specifications - AK 200™ S dialysis machine 7:9 Peracetic Acid Program Concentration of disinfectant Concentration in machine Consumption Fill up and mixing phase Dwell time Rinse/Drain phase Total time 3.5 % peracetic acid 0.1 %; i.e. diluted 1 + 34 Approx. 65 ml (Approx. 75 ml with UFD-kit, (optional)) 12 minutes (17 minutes with UFD-kit, (optional)) 10 minutes 23 minutes (43 minutes with UFD-kit, (optional)) 45 minutes including 10 min dwell time (70 minutes including 10 min dwell time with UFD-kit, (optional)) Low concentration Peracetic Acid Program Concentration of disinfectant Concentration in machine Consumption Fill up and mixing phase Dwell time Rinse/Drain phase Total time 0.35 % peracetic acid (0.35 % peracetic acid with UFD-kit, (optional)) 0.01 % ; i.e. diluted 1 + 34 (0.01 % ; i.e. diluted 1 + 34 with UFD-kit, (optional)) approx. 65 ml (approx. 75 ml with UFD-kit, (optional)) 12 minutes (17 minutes with UFD-kit, (optional)) 10 minutes 16 minutes (28 minutes with UFD-kit, (optional)) 38 minutes including 10 min dwell time (55 minutes including 10 min dwell time with UFD-kit, (optional)) Hypochlorite Program Concentration of disinfectant Concentration in machine Consumption Fill up and mixing phase Dwell time Rinse/Drain phase Total time 7:10 0.5% available chlorine (approximately 70% of sodium hypochlorite concentration) 0.5% ; i.e. not diluted Approx. 2000 ml (Approx. 2500 ml with UFD-kit, (optional)) 12 minutes (25 minutes with UFD-kit, (optional)) 10 minutes, Maximum 20 min 23 minutes (39 minutes with UFD-kit, (optional)) 45 minutes including 10 min dwell time (74 minutes including 10 min dwell time with UFD-kit, (optional)) Tech. data and specifications - AK 200™ S dialysis machine HCEN9287 Revision 10.2012 Central Chemical Disinfection Program Concentration of disinfectant Concentration in machine Consumption Dwell time Total time 0.1% peracetic acid or 0.5% available chlorine Not diluted Approx. 3100 ml (Approx. 3600 ml with UFD-kit, (optional)) Must be preset, maximum 20 min. for hypochlorite 32 minutes (dwell time not included) (64 minutes (dwell time not included) with UFD-kit, (optional)) Other programs, total time Rinse/Drain Drain 12 min (13 min with UFD-kit, (optional)) 4 min External Cleaning 70% ethanol or 60% Isopropanol Water supply HCEN9287 Revision 10.2012 Water Supply Flow Rate Treatment Disinfection 300 to 750 ml/min 0 to 1150 ml/min Inlet Water Pressure to regulator to machine 120 to 800 kPa 85 to 120 kPa Inlet Water Temperature Treatment Disinfection +5 to +30 °C +5 to +90 °C Inlet Water Quality Inlet water quality must comply with local regulations and if no such regulation is available follow ISO 13959. Level for conductivity shall not exceed 0.1 mS/cm. It is possible to use water with higher conductivity if it consists mainly of sodium salts. This may however affect the accuracy of the fluid composition. Inlet tube length Maximum 5 m or the specially designed spiral PEX tubing Tech. data and specifications - AK 200™ S dialysis machine 7:11 Drain Drain (length of tube) Drain capacity Drain outlet Maximum 5 m Minimum 1.0 l/min Maximum 1.2 m above floor If the optional air-gap on the machine is used the distance between the air-gap and the drain must not be less than 0.3 m. For an electrically adjustable stand in its lowest position this means that the drain must not be higher than 580 mm. For a mechanically adjustable stand in its lowest position the drain must not be higher than 550 mm. Power supply Mains Voltage Frequency Power Consumption Mains cable: Mains cable connector: Mains cable plug: Earth Leakage Current Patient Leakage Current Fuses 115 or 230 V AC (±10%) 50 or 60 Hz (±5 Hz) Max. 2250 W at 230 V Max. 1650 W at 115 V 3 conductor cable, Length max. 3 m rating 250 V 10 A, 13 -16A Certified to IEC 60320/C19 Plug with protective earth, 250 V AC / 13 -16 A, or Hospital grade plug with protective earth, 125 V AC / 15 A. max 500 μA max 100 μA 2 x T 10 A All leakage currents are specified without external equipment connected to the machine. Connection of external equipment Additional equipment connected to medical electrical equipment must comply with the respective IEC or ISO standards (e.g. IEC 60950 for data processing equipment). Furthermore all configurations shall comply with the requirements for medical electrical systems (see IEC 60601–1–1 or clause 16 of the 3Ed. of IEC 60601–1, respectively). Anybody connecting additional equipment to medical electrical equipment configures a medical system and is therefore responsible that the system complies with the requirements for medical electrical systems. Attention is drawn to the fact that local laws take priority over the above mentioned requirements. If in doubt, consult your local representative or the technical service department. Use of other cables may result in increased emissions or decreased immunity for the equipment or system. Protective caps shall be attached when the connectors are not in use. 7:12 Tech. data and specifications - AK 200™ S dialysis machine HCEN9287 Revision 10.2012 External serial interface External connector P 63 External equipment 8 pin REDEL contact, black. RS-232 or RS-422 compatible connection. Opto insulated fulfilling IEC 60601-1-1. Attached cable length 2.5 m unshielded. Serial port for connection to PC used for logging and preset. RS-232 Max input voltage High level min output voltage Low level max output voltage Max output current ± 15 V DC + 5 V DC - 5 V DC ± 5 mA RS-422 Max input voltage Diff. input threshold voltage Diff. max. output voltage Diff. min. output voltage Short circuit output current ± 7 V DC ± 0.2 V DC 5 V DC 2 V DC 100 mA External interface External connector P 79 External equipment Contact ratings Max voltage Max current 8 pin REDEL, yellow, configured as 1 make- and 2 change over- relay contacts. Attached cable length 2.9 m unshielded. Port for connection to central alarm system and remote control of water system. 24 V AC or DC 100 mA AC or DC External I/O Interface External connector P 76 External equipment 8 pin REDEL blue. Opto insulated fulfilling IEC 60601-1-1. Attached cable length 1.5 m unshielded. Connection to Gambro UF Calibration Unit. Service purpose only. External interface External connector P 64 External equipment HCEN9287 Revision 10.2012 8 pin RJ-45 Ethernet port for connection to network only intended for ExalisⓇ computer system, download, preset and logging Tech. data and specifications - AK 200™ S dialysis machine 7:13 Battery Back-up Battery back-up of power supply Running time Fuse 7:14 24 volt, 6.5 Ah >15 minutes T 15 A Tech. data and specifications - AK 200™ S dialysis machine HCEN9287 Revision 10.2012 Performance and specification Supervisory system Note • When accuracy ranges are written as e.g. “(±1 ml/min or ±1%)” the widest range is valid. Note Blood Pressure Supervision The alarm limits below can be preset. The value put in brackets and in italics is the default value. Venous Pressure Operating range Alarm limit HIGH max Alarm limit LOW min -700 to +750 mmHg (±10% at -700 to -500 mmHg) (±5 mmHg or 3% at -500 to +500 mmHg) (±10% at +500 to +750 mmHg) +600 mmHg (+300 mmHg) -50 mmHg (-50 mmHg) When blood is detected the operator is requested to centralize the alarm limits and the low limit is by default set to +10 mmHg Arterial Pressure Operating range Alarm limit HIGH max Alarm limit LOW min. -700 to +750 mmHg (±10% at -700 to -500 mmHg) (±5 mmHg or 3% at -500 to +500 mmHg) (±10% at +500 to +750 mmHg) +750 mmHg (+250 mmHg) -700 mmHg (-250 mmHg) System Pressure Operating range Alarm limit SN/DP HIGH max Alarm limit SN/DP LOW min. Alarm limit SP HIGH max Alarm limit SP LOW min. HCEN9287 Revision 10.2012 -700 to +750 mmHg (±10% at -700 to -500 mmHg) (±5 mmHg or 3% at -500 to +500 mmHg) (±10% at +500 to +750 mmHg) +300 mmHg (+175 mmHg) -200 mmHg (+10 mmHg) +750 mmHg (+150 mmHg) - Tech. data and specifications - AK 200™ S dialysis machine 7:15 Air Detection Sensitivity Venous drip chamber size (diameter) Bubbles larger than 1 μl will be trapped by the drip chamber. An alarm will be issued if the blood level falls below the middle of the air detector. 22 mm Heparin Administration Heparinization volume alarm limit ±0.3 ml of set value (±1 ml or 0.2 ml * heparinization time (h) or ±5%) The accuracy is based on tests with 20 ml and 30 ml syringes Dialysis fluid preparation Temperature Low temperature alarm limit High temperature alarm limit 32.5 °C (+0.5/-2.0 °C) 41.5 °C (+0.5/-2.5 °C) (+0.5/-2.7 °C) with UFD-kit at fluid flow < 500 ml/min. Conductivity Alarm limits in Acetate ±5% of set value mode Alarm Limit in Bicarbonate ±5% of set value for A-step conductivity mode, A-step (acidic) Alarm Limit in Bicarbonate ±5% of set value for B-step conductivity mode, B-step (bicarbonate) Alarm limits are temporarily extended to 10%. Maximum mean deviation for a 5 hour treatment is 0.2 mS/cm. Dialysis fluid preparation (BiCart SelectⓇ concentrate system mode only) Dialysis Fluid Flow Rate Dialysis Fluid Flow Rate alarm limit 1 L SelectBag concentrate Proportioning Ratio alarm limit 7:16 300 - 700 ml/min (±9 ml/min) ±5% 1:200 ±12%, alarm given within 20 minutes. For larger errors the alarm time is shorter. 1 L SelectBag concentrate Proportioning Ratio is defined as the quotient 1 L SelectBag concentrate flow/dialysis fluid flow Tech. data and specifications - AK 200™ S dialysis machine HCEN9287 Revision 10.2012 Ultrafiltration Dialysis fluid flow operating range UF rate supervision 300 - 700 ml/min -4.0 to +4.0 l/h (±2 ml/min) Accuracy ±5 ml/min verified at start-up. ±1 - 10 ml/min, (±5 ml/min) UF rate supervision, max allowed difference between control and protective system, can be preset (Default) Accumulated UF volume ±200 ml or ±70 - 130 ml/h (±130 ml/h) alarm limit, (Default) * passed treatment time (h), whichever is greatest. Treatment Time Control 0.05 to 9.59 hour.minute (±1 minute) TMP supervision alarm -200 to +550 mmHg (±15 mmHg) For AK 200 S dialysis machine, TMP is defined as Pb out - Pd out + Offset, where Pb out is the venous drip chamber pressure and Pd out is the pressure measured in the dialysis fluid, where it enters the machine after the dialyzer. The offset compensates for the vertical distance between the pressure sensors. Blood leak detection Sensitivity Alarm response time (diffusion mode) ≥0.15 ml blood/min at 300 ml/min dialysis fluid flow rate ≥0.35 ml blood/min at 700 ml/min dialysis fluid flow rate haematocrit 32% ±2% 7 seconds Blood loss due to coagulation Supervision of blood pump 10 to 180 seconds (60 seconds) stop time (Default) HCEN9287 Revision 10.2012 Tech. data and specifications - AK 200™ S dialysis machine 7:17 Physical data Depth Width Total Height Floor Area Weight Blood Monitor Weight Fluid Monitor Weight Stand Total Weight Infusion Stand Height Transportation Approx. 610 mm Approx. 570 mm Adjustable heights 1175 - 1340 mm Five position stand 1152 - 1382 mm 573 x 753 mm Approx. 17 kg Approx. 40 kg Approx. 24 to 31 kg Approx. 81 to 88 kg 1300 to 2150 mm Max. load 10 kg One man installation Fitting into a normal Estate car References Assembly Drawing: K22100 7:18 Tech. data and specifications - AK 200™ S dialysis machine HCEN9287 Revision 10.2012 Materials in contact with water, concentrates and dialysis fluid Polymers Silicon rubber Santroprene PVC (Polyvinylchloride) PEEK (Polyetherketone) PEX (Polyethylene) PP (Polypropylene) PP (Polypropylene reinforced with talcum) PSU (Polysulphone) PVDF (Polyvinylidene fluoride) PTFE (Polytetrafluoro ethylene) Parylene C Metals Stainless steel SS2343 Stainless steel SS2353 Stainless steel SS2562 Titanium Platinum Others Carbon Ceramic, Steatite 221 Ceramic, Aluminum oxide (Al2O3) Ceramic, Zirconium oxide (ZrO2) Glass Barium Ferrite HCEN9287 Revision 10.2012 Tech. data and specifications - AK 200™ S dialysis machine 7:19 Environmental data Operation If condensation occur when moving the equipment between locations with different temperatures and high relative humidity (e.g. outdoor and indoor locations), the inside of the equipment shall be allowed to dry before switching on the equipment. Ambient Temperature range Relative Humidity range Air Pressure range (atm. pressure) Maximum altitude +18 to +35 °C 15 to 85% RH 700 to 1060 hPa ≈ 2000 m above sea level Transportation and storage During transportation and storage the equipment has to be kept in its original packing. If transportation or storage time is more than 15 weeks, the environmental data relating to the operation has to be followed. The maximum ambient temperature for transportation and storage in 96% Relative humidity is +40 °C. Ambient Temperature range Relative Humidity range Air Pressure range (atm. pressure) Maximum altitude -20 to +70 °C 10 to 96% RH 500 to 1060 hPa ≈ 2000 m above sea level Energy Typical energy consumption for a 4 hour treatment with inlet water temperature of 5 °C and 500 ml/h main flow is 2.7 kWh. Energy delivery to the environment is approximately 400 Wh independent of inlet water temperature. Energy delivery to the drain during a 4 hour treatment is 2.3 kWh. The temperature at the drain can be up to 80 °C. Power consumption and delivery to the drain decrease with approximately 19 W for every degree increase of inlet water temperature. 7:20 Tech. data and specifications - AK 200™ S dialysis machine HCEN9287 Revision 10.2012 Electromagnetic environment The AK 200 S dialysis machine is intended for use in the electromagnetic environment specified below. The customer or the user of the AK 200 S dialysis machine should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment – guidance RF emissions CISPR 11 Group 1 The AK 200 S dialysis machine uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class B The AK 200 S dialysis machine is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes Harmonic emissions IEC 61000-3-2 Class A (Not applicable for 115 V version) Voltage fluctuations /flicker emissions IEC 61000-3-3 Complies (Not applicable for 115 V version) HCEN9287 Revision 10.2012 Tech. data and specifications - AK 200™ S dialysis machine 7:21 Immunity test IEC 60601 test level Compliance level Electromagnetic environment-guidance Electrostatic discharge (ESD), IEC 61000-4-2 ±6 kV contact ±8 kV Air ±6 kV contact ±8 kV Air Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %. Electrical fast transient/burst, IEC 61000-4-4 ±2 kV for power lines ±1kV for input/output lines ±2 kV for power lines ±1kV for input/output lines Mains power quality should be that of a typical commercial or hospital environment. Surge IEC 61000-4-5 ±1kV for differential mode ±2kV for common mode ±1kV for differential mode ±2kV for common mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips, short interruptions and voltage variations on power supply input lines. IEC 61000-4-11 <5 % UT (>95 % dip in UT) for 0.5 cycle 40 % UT (60 % dip in UT) for 5 cycles 70 % UT (30 % dip in UT) for 25 cycles <5 % UT (>95 % dip in UT) for 5 sec <5 % UT (>95 % dip in UT) for 0.5 cycle 40 % UT (60 % dip in UT) for 5 cycles 70 % UT (30 % dip in UT) for 25 cycles <5 % UT (>95 % dip in UT) for 5 sec Mains power quality should be that of a typical commercial or hospital environment. If the user of the AK 200 S dialysis machine requires continued operation during power mains interruptions, it is recommended that the AK 200 S dialysis machine be powered from an uninterruptible power supply or a battery. Power frequency (50/60 Hz) magnetic field IEC 61000-4-8 3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. Note • UT is the a.c. mains voltage prior to application of the test level. Note 7:22 Tech. data and specifications - AK 200™ S dialysis machine HCEN9287 Revision 10.2012 Immunity test IEC 60601 test level Compliance level Electromagnetic enviroment-guidance Portable and mobile RF communications equipment should be used no closer to any part of the AK 200 S dialysis machine, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance Conducted RF IEC 61000-4-6 3 Vrms 150 kHz to 80 MHz 3V Radiated RF IEC 61000-4-3 3 V/m 80 MHz to 2.5 GHz 3 V/m Radiated RF mobile phones - 30V/m 80 MHz to 800 800 MHz to 2.5 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey3, should be less than the compliance level in each frequency range4. Interference may occur in the vicinity of equipment marked with the following symbol: Note • At 80 MHz and 800 MHz, the higher frequency range applies. • These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Note 3 Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the AK 200 S dialysis machine is used exceeds the applicable RF compliance level above, the AK 200 S dialysis machine should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the AK 200 S dialysis machine. 4 Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. HCEN9287 Revision 10.2012 Tech. data and specifications - AK 200™ S dialysis machine 7:23 Recommended separation distances between portable and mobile RF communications equipment and the AK 200 S dialysis machine The AK 200 S dialysis machine is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the AK 200 S dialysis machine can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the AK 200 S dialysis machine as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter W Separation distance according to frequency of transmitter (m) 150kHz - 80MHz 80MHz - 800MHz 800MHz - 2500MHz 0.01 0.11 0.11 0.23 0.1 0.37 0.37 0.74 1 1.2 1.2 2.3 10 3.7 3.7 7.4 100 12 12 23 Rated maximum output power of mobile phone - - 2W GSM/3G - - 0.33 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. Note • At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. • These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Note 7:24 Tech. data and specifications - AK 200™ S dialysis machine HCEN9287 Revision 10.2012 Standards The machine complies with the following standards: IEC 60601-1 General requirements for safety, Class I, type B IEC 60601-2-16 Particular requirements for safety of haemodialysis, haemodiafiltration and haemofiltration equipment IEC 60601-2-30 Particular requirements for the safety of automatic cycling indirect blood pressure monitoring equipment IEC 60601-1-2 Electromagnetic compatibility EN 1060-1 Non-invasive sphygmomanometers Part 1: General requirements EN 1060-3 Non-invasive sphygmomanometers Part 3: Supplementary requirements for electromechanical blood pressure measuring systems NFS 90-304 Medico-surgical equipment Hemodialysis equipment HCEN9287 Revision 10.2012 Tech. data and specifications - AK 200™ S dialysis machine 7:25 This page is intentionally left blank 7:26 Tech. data and specifications - AK 200™ S dialysis machine HCEN9287 Revision 10.2012 Chapter 8 Technical data and specifications - AK 200™ ULTRA S dialysis machine Contents Performance and specification - Control System . . . . . . . . . . . . . . . . . Blood Flow Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Air Detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Heparin Administration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Blood Volume Sensor (BVS) . . . . . . . . . . . . . . . . . . . . . . . . . . Blood Pressure Monitor (BPM) . . . . . . . . . . . . . . . . . . . . . . . . Dialysis fluid preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Dialysis fluid preparation (BiCart SelectⓇ concentrate system mode only) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Ultrafiltration control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Substitution fluid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Profiling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . DiascanⓇ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Disinfection and Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . Water supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Drain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Power supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Connection of external equipment . . . . . . . . . . . . . . . . . . . . . . Battery Back-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Performance and specification - Supervisory system . . . . . . . . . . . . . . Blood Pressure Supervision . . . . . . . . . . . . . . . . . . . . . . . . . . . Air Detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Heparin Administration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Dialysis fluid preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Dialysis fluid preparation (BiCart SelectⓇ concentrate system mode only) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Ultrafiltration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Blood leak detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Blood loss due to coagulation . . . . . . . . . . . . . . . . . . . . . . . . . . Physical data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Materials in contact with water, concentrates and dialysis fluid . . . . . . Polymers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Metals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Others . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Environmental data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Transportation and storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . Energy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Electromagnetic environment . . . . . . . . . . . . . . . . . . . . . . . . . . Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . HCEN9297 Revision 10.2012 Tech. data and specifications - AK 200™ ULTRA S dialysis machine 8:2 8:2 8:3 8:3 8:3 8:4 8:5 8:6 8:6 8:6 8:7 8:7 8:8 8:11 8:11 8:12 8:12 8:14 8:15 8:15 8:16 8:16 8:16 8:16 8:17 8:17 8:17 8:18 8:18 8:19 8:19 8:19 8:19 8:20 8:20 8:20 8:20 8:21 8:25 8:1 Performance and specification - Control System Note • When accuracy ranges are written as e.g. “(±1 ml/min or ±1%)” the widest range is valid. • For the qualified technician, the Service Manual for the AK 200 ULTRA S dialysis machine is available. The Service Manual provides all the necessary information for the safe and required maintenance of the machine. Note Blood Flow Control Values for the blood pump(s) are based on the arterial blood pump with a pump segment of 7.9 mm and 2.0 mm wall thickness. For paediatric blood tubes with pump segment of 4.0 mm it is also possible to set blood flow to 10 or 15 ml/min. Accuracy is then ±5 ml/min. Double Needle Blood Flows in HD, single 20 to 500 ml/min (±10 ml/min or ±15%) pump Blood Flows in HDF, HF 20 to 700 ml/min (±10 ml/min or ±15%) Accumulated blood volume 0 to 327 litres (±0.6 l * treatment time (h) or ±15%) Single Needle Single Pump (HD, HDF only) Arterial flow Time control 20 to 500 ml/min (±10 ml/min or ±18%) 2 to 20 sec (±1 sec), Arterial and venous time. The actual clamp opening time is depending on blood flow rate, size of expansion chamber and pressure limits. Pressure control 10 to 600 mmHg (±50 mmHg), venous pressure control Accumulated blood volume 0 to 327 litres (±0.6 l * treatment time (h) or ±18%) Single Needle Double Pump (HD only) Double pump-A Double pump-V Mean Flow-SN/DP Accumulated blood volume Stroke Volume-SN/DP 8:2 20 to 800 ml/min 20 to 800 ml/min 10 to 400 ml/min (±10 ml or ±15%) 0 to 99.9 litres (±0.6 l * treatment time (h) or ±15%) 2 to 60 ml/stroke (±15%) at a cycle time < 20 s Tech. data and specifications - AK 200™ ULTRA S dialysis machine HCEN9297 Revision 10.2012 Air Detection Sensitivity Venous drip chamber size (diameter) Bubbles larger than 1 μl will be trapped by the drip chamber. An alarm will be issued if the blood level falls below the middle of the air detector. 22 mm Heparin Administration Heparinization 0/0.5 to 10 ml/h (±1 ml or 0.2 ml * heparinization time (h) or ±5%) 0 to 4.00 h.min (±1 min) (20 min) Stop time, can be preset (Default) Syringe size, can be preset 10 to 30 ml (30 ml) (Default) Maximum counter pressure +650 mmHg The accuracy is based on tests with 20 ml and 30 ml syringes Blood Volume Sensor (BVS) Relative blood volume ∆BV HCEN9297 Revision 10.2012 - 40% to + 10% from reference value (Standard deviation ±3%) Sensor active for Hb ≥ 80 g/l and blood flow ≥180 ml/min Tech. data and specifications - AK 200™ ULTRA S dialysis machine 8:3 Blood Pressure Monitor (BPM) The alarm limits below can be preset. The value put in brackets and in italics is the default value. Systolic pressure range1,2 Low alarm limit, can be preset (Default) High alarm limit, can be preset (Default) Diastolic pressure range1,2 Low alarm limit, can be preset (Default) High alarm limit, can be preset (Default) Mean pressure range1,2 Low alarm limit, can be preset (Default) High alarm limit, can be preset (Default) 40 - 260 mmHg 60 - 250 mmHg (100 mmHg) 60 - 250 mmHg (180 mmHg) 20 - 200 mmHg 40 - 200 mmHg (40 mmHg) 40 - 200 mmHg (110 mmHg) 26 - 220 mmHg 45 - 235 mmHg (45 mmHg) 45 - 235 mmHg (235 mmHg) Rated cuff pressure range2 120 - 280 mmHg Pulse rate range 2 30 - 220 bpm (±2 bpm or ±2 % of reading) 40 - 180 bpm (40 bpm) Low alarm limit, can be preset (Default) High alarm limit, can be preset (Default) 40 - 180 bpm (130 bpm) 1 Meets ANSI/AAMI SP-10 (1992). Mean error ±5 mmHg. Standard deviation 8 mmHg 2 The rated range is valid for the blood pressure monitor Suntech firmware version 3.41 or higher. 8:4 Tech. data and specifications - AK 200™ ULTRA S dialysis machine HCEN9297 Revision 10.2012 Dialysis fluid preparation Temperature Dialysis Fluid Temperature 33-40 °C (+0.5/-1.5 °C) (+0.5/-2.7 °C) at fluid flow < 500 ml/min. Temperature low alarm, can 31 to 41 °C (35°) be preset (Default) Temperature high alarm, 31 to 41 °C (39°) can be preset (Default) Fluid flow Dialysis Fluid Flow Rate 300 to 700 ml/min (±10 ml/min) Conductivity Conductivity measuring Alarm limits in Acetate mode Alarm limit in Bicarbonate mode, A-step (acidic) Alarm Limit in Bicarbonate mode, B-step (bicarbonate) 0.1 - 20 mS/cm (±0.1 mS/cm) ±5 % of set value ±5% of set value for A-step conductivity ±5% of set value for B-step conductivity Alarm limits are extended to 10% for maximum 2 minutes of 10 minutes Concentration Na+, Acetate mode Na+, Bicarbonate mode HCO3-, Bicarbonate mode 115 to 160 mmol/l (±4 mmol/l) 130 to 150 mmol/l (±6 mmol/l) 20 to 40 mmol/l (±6 mmol/l) Concentrates Max. pressure for concentrates +50 kPa pH supervision pH measurement of Dialysis Fluid 1 to 9.9 pH units (±0.2 pH units for pH 5 to 9, ±0.5 pH units for pH<5 or pH>9) pH low alarm, can be preset 1 to 15 pH units (6 Acetate mode, 6.5 (Default) Bicarb mode) pH high alarm, can be 1 to 15 pH units (8 Acetate mode, 7.8 preset (Default) Bicarb mode) HCEN9297 Revision 10.2012 Tech. data and specifications - AK 200™ ULTRA S dialysis machine 8:5 Degassing Degassing pressure in Acetate mode, can be preset (Default) Degassing pressure in Bicarbonate mode, can be preset (Default) -700 to -500 mmHg (±30 mmHg) (-630 mmHg) Minimum 75 mmHg absolute pressure -700 to -500 mmHg (±30 mmHg) (-580 mmHg) Minimum 75 mmHg absolute pressure Dialysis fluid preparation (BiCart SelectⓇ concentrate system mode only) Fluid flow 1 L SelectBag concentrate Proportioning Ratio 1:200 (±3%) 1 L SelectBag concentrate Proportioning Ratio is defined as the quotient 1 L SelectBag concentrate flow/dialysis fluid flow On-line Saline Priming (OSP) Sodium concentration 154 mmol/l (±4 mmol/l) Ultrafiltration control Volume control UF volume UF-rate Treatment Time max. 30 litres (±50 ml or ±50 ml * passed treatment time (h) or ±2.5%) 0.0 to 4.0 l/h 0.05 to 9.59 hour.minute (±1 minute) Pressure control (On-line mode) Constant TMP in on-line mode, where TMP for AK 200 ULTRA S dialysis machine is defined as the difference, Pb out - Pd out, where Pb out is the venous drip chamber pressure and Pd out is the pressure measured in the dialysis fluid, where it enters the machine after the dialyzer. TMP -200 to +550 mmHg (±15 mmHg) Substitution fluid Substitution fluid flow rate Substitution volume 8:6 0.3 to 27.0 litres/h (±10%) at 500 ml/min flow rate. Limitations at lower flow rates. max. 150 litres Tech. data and specifications - AK 200™ ULTRA S dialysis machine HCEN9297 Revision 10.2012 Profiling UF-rate Na+, Acetate mode Na+, Bicarbonate mode HCO3-, Bicarbonate mode 0 to 4 l/h 115 to 160 mmol/l 130 to 150 mmol/l 20 to 40 mmol/l Half-times: Degressive Set in h.min, 10 to 25% of remaining treatment time Set in h.min, 75 to 90% of remaining treatment time Progressive DiascanⓇ Accuracy is valid in HD mode double needle treatment and on-line HDF mode double needle treatment, for blood flows 200 to 500 ml/min and fluid flows 500 to 700 ml/min, UF profiling is allowed. Clearance, K Cumulated water volume cleared of urea, Kt Dialysis dose, Kt/V Plasma sodium, Na+ HCEN9297 Revision 10.2012 0 to 350 ml/min (±10%) 0 to 100 l (±10%) 0 to 3 (±10%) 130 to 160 mmol/l Tech. data and specifications - AK 200™ ULTRA S dialysis machine 8:7 Disinfection and Cleaning Temperature and time in different phases and concentration of disinfectant are possible to preset. The values in this specification are the default values and what the machine has been validated against. Follow the instructions from the manufacturer of the disinfectant, to set the correct dilution and dwell time. All disinfection programs in the AK 200 ULTRA S dialysis machine are tested in accordance with the French standard NFS 90-304 and established to fulfil the requirements expressed in the same standard. Time for disinfection programs is estimated and may vary. All values below are applicable for the 230V AC variant. For the 115V AC variant add 7 minutes to all heating programs. Heat disinfection Program Temperature Fill up phase Circulation phase Drain phase Total time 93 °C 13 minutes 15 minutes 4 minutes 32 minutes Heat disinfection Program with CleanCartⓇ cartridge Decalcification Cleaning Temperature Fill up and mixing phase Circulation phase Rinse/Drain phase Total time CleanCart C CleanCart A 93 °C 13 minutes 15 minutes 11 minutes 39 minutes Heat disinfection Program with liquid citric acid Temperature Concentration Concentration in machine Consumption Fill up and mixing phase Circulation phase Rinse/Drain phase Total time 93 °C 20 % citric acid 2 % citric acid; i.e. diluted 1 + 9 Approx. 260 ml 19 minutes 15 minutes 10 minutes 44 minutes Heat disinfection Program with WRO 300 H Temperature Fill up phase Circulation phase Low flow heat phase Drain phase Total time 8:8 93 °C 13 minutes 15 minutes 20 minutes 4 minutes 52 minutes Tech. data and specifications - AK 200™ ULTRA S dialysis machine HCEN9297 Revision 10.2012 Heat disinfection Program with CleanCartⓇ cartridge including WRO 300 H Decalcification Cleaning Temperature Fill up phase Circulation phase Low flow heat phase Rinse/Drain phase Total time CleanCart C CleanCart A 93 °C 13 minutes 15 minutes 20 minutes 11 minutes 59 minutes Peracetic Acid Program Concentration of disinfectant Concentration in machine Consumption Fill up and mixing phase Dwell time Rinse/Drain phase Total time 3.5 % peracetic acid 0.1 % ; i.e. diluted 1 + 34 Approx. 85 ml 17 minutes 10 minutes 43 minutes 70 minutes including 10 min dwell time Low concentration Peracetic Acid Program Concentration of disinfectant Concentration in machine Consumption Fill up and mixing phase Dwell time Rinse/Drain phase Total time 0.35 % peracetic acid 0.01 % ; i.e. diluted 1 + 34 approx. 85 ml 17 minutes 10 minutes 28 minutes 55 minutes including 10 min dwell time Hypochlorite Program Concentration of disinfectant Concentration in machine Consumption Fill up and mixing phase Dwell time Rinse/Drain phase Total time HCEN9297 Revision 10.2012 0.5% available chlorine (approximately 70% of sodium hypochlorite concentration) 0.5% ; i.e. not diluted Approx. 3000 ml 25 minutes 10 minutes, Maximum 20 min 39 minutes 74 minutes including 10 min dwell time Tech. data and specifications - AK 200™ ULTRA S dialysis machine 8:9 Central Chemical Disinfection Program Concentration of disinfectant Concentration in machine Consumption Dwell time Total time 0.1% peracetic acid or 0.5% available chlorine Not diluted Approx. 4100 ml Must be preset, maximum 20 min. for hypochlorite 64 minutes (dwell time not included) Other programs, total time 8:10 Rinse/Drain Drain 13 min 4 min External Cleaning 70% ethanol or 60% Isopropanol Tech. data and specifications - AK 200™ ULTRA S dialysis machine HCEN9297 Revision 10.2012 Water supply Water Supply Flow Rate Treatment Disinfection 450 to 850 ml/min 0 to 900 ml/min Inlet Water Pressure to regulator to machine 120 to 800 kPa 85 to 120 kPa Inlet Water Temperature Treatment Disinfection +5 to +30 °C +5 to +90 °C Inlet Water Quality Inlet water quality must comply with local regulations and if no such regulation is available follow ISO 13959. Level for conductivity shall not exceed 0.1 mS/cm.It is possible to use water with higher conductivity if it consists mainly of sodium salts. This may however affect the accuracy of the fluid composition. Inlet tube length Maximum 5 m or the specially designed spiral PEX tubing Drain Drain (length of tube) Drain capacity Drain outlet Maximum 5 m Minimum 1.0 l/min Maximum 1.2 m above floor If the optional air-gap on the machine is used the distance between the air-gap and the drain must not be less than 0.3 m. For an electrically adjustable stand in its lowest position this means that the drain must not be higher than 580 mm. For a mechanically adjustable stand in its lowest position the drain must not be higher than 550 mm. HCEN9297 Revision 10.2012 Tech. data and specifications - AK 200™ ULTRA S dialysis machine 8:11 Power supply Mains Voltage Frequency Power Consumption Mains cable: Mains cable connector: Mains cable plug: Earth Leakage Current Patient Leakage Current Fuses 115 or 230 V AC (±10%) 50 or 60 Hz (±5 Hz) Max. 2250 W at 230 V Max. 1650 W at 115 V 3 conductor cable, Length max. 3 m rating 250 V 10 A, 13 -16A Certified to IEC 60320/C19 Plug with protective earth, 250 V AC / 13 -16 A, or Hospital grade plug with protective earth, 125 V AC / 15 A. max 500 μA max 100 μA 2 x T 10 A All leakage currents are specified without external equipment connected to the machine. Connection of external equipment Additional equipment connected to medical electrical equipment must comply with the respective IEC or ISO standards (e.g. IEC 60950 for data processing equipment). Furthermore all configurations shall comply with the requirements for medical electrical systems (see IEC 60601–1–1 or clause 16 of the 3Ed. of IEC 60601–1, respectively). Anybody connecting additional equipment to medical electrical equipment configures a medical system and is therefore responsible that the system complies with the requirements for medical electrical systems. Attention is drawn to the fact that local laws take priority over the above mentioned requirements. If in doubt, consult your local representative or the technical service department. Use of other cables may result in increased emissions or decreased immunity for the equipment or system. Protective caps shall be attached when the connectors are not in use. 8:12 Tech. data and specifications - AK 200™ ULTRA S dialysis machine HCEN9297 Revision 10.2012 External serial interface External connector P 63 External equipment 8 pin REDEL contact, black. RS-232 or RS-422 compatible connection. Opto insulated fulfilling IEC 60601-1-1. Attached cable length 2.5 m unshielded. Serial port for connection to PC used for logging and preset. RS-232 Max input voltage High level min output voltage Low level max output voltage Max output current ± 15 V DC + 5 V DC - 5 V DC ± 5 mA RS-422 Max input voltage Diff. input threshold voltage Diff. max. output voltage Diff. min. output voltage Short circuit output current ± 7 V DC ± 0.2 V DC 5 V DC 2 V DC 100 mA External interface External connector P 79 External equipment Contact ratings Max voltage Max current 8 pin REDEL, yellow, configured as 1 make- and 2 change over- relay contacts. Attached cable length 2.9 m unshielded. Port for connection to central alarm system and remote control of water system. 24 V AC or DC 100 mA AC or DC External I/O Interface External connector P 76 External equipment 8 pin REDEL blue. Opto insulated fulfilling IEC 60601-1-1. Attached cable length 1.5 m unshielded. Connection to Gambro UF Calibration Unit. Service purpose only. External interface External connector P 64 External equipment HCEN9297 Revision 10.2012 8 pin RJ-45 Ethernet port for connection to network only intended for ExalisⓇ computer system, download, preset and logging Tech. data and specifications - AK 200™ ULTRA S dialysis machine 8:13 Battery Back-up Battery back-up of power supply Running time Fuse 8:14 24 volt, 6.5 Ah >15 minutes T 15 A Tech. data and specifications - AK 200™ ULTRA S dialysis machine HCEN9297 Revision 10.2012 Performance and specification Supervisory system Note • When accuracy ranges are written as e.g. “(±1 ml/min or ±1%)” the widest range is valid. Note Blood Pressure Supervision The alarm limits below can be preset. The value put in brackets and in italics is the default value. Venous Pressure Operating range Alarm limit HIGH max Alarm limit LOW min -700 to +750 mmHg (±10% at -700 to -500 mmHg) (±5 mmHg or 3% at -500 to +500 mmHg) (±10% at +500 to +750 mmHg) +600 mmHg (+300 mmHg) -50 mmHg (-50 mmHg) When blood is detected the operator is requested to centralize the alarm limits and the low limit is by default set to +10 mmHg Arterial Pressure Operating range Alarm limit HIGH max Alarm limit LOW min. -700 to +750 mmHg (±10% at -700 to -500 mmHg) (±5 mmHg or 3% at -500 to +500 mmHg) (±10% at +500 to +750 mmHg) +750 mmHg (+250 mmHg) -700 mmHg (-250 mmHg) System Pressure Operating range Alarm limit SN/DP HIGH max Alarm limit SN/DP LOW min. Alarm limit SP HIGH max Alarm limit SP LOW min. HCEN9297 Revision 10.2012 -700 to +750 mmHg (±10% at -700 to -500 mmHg) (±5 mmHg or 3% at -500 to +500 mmHg) (±10% at +500 to +750 mmHg) +300 mmHg (+175 mmHg) -200 mmHg (+10 mmHg) +750 mmHg (+150 mmHg) - Tech. data and specifications - AK 200™ ULTRA S dialysis machine 8:15 Air Detection Sensitivity Venous drip chamber size (diameter) Bubbles larger than 1 μl will be trapped by the drip chamber. An alarm will be issued if the blood level falls below the middle of the air detector. 22 mm Heparin Administration Heparinization volume alarm limit ±0.3 ml of set value (±1 ml or 0.2 ml * heparinization time (h) or ±5%) The accuracy is based on tests with 20 ml and 30 ml syringes Dialysis fluid preparation Temperature Low temperature alarm limit High temperature alarm limit 32.5 °C (+0.5/-2.0 °C) 41.5 °C (+0.5/-2.7 °C) Conductivity Alarm limits in Acetate ±5% of set value mode Alarm Limit in Bicarbonate ±5% of set value for A-step conductivity mode, A-step (acidic) Alarm Limit in Bicarbonate ±5% of set value for B-step conductivity mode, B-step (bicarbonate) Alarm limits are temporarily extended to 10%. Maximum mean deviation for a 5 hour treatment is 0.2 mS/cm. Dialysis fluid preparation (BiCart SelectⓇ concentrate system mode only) Dialysis Fluid Flow Rate Dialysis Fluid Flow Rate alarm limit 1 L SelectBag concentrate Proportioning Ratio alarm limit 8:16 300 - 700 ml/min (±9 ml/min) ±5% 1:200 ±12%, alarm given within 20 minutes. For larger errors the alarm time is shorter. 1 L SelectBag concentrate Proportioning Ratio is defined as the quotient 1 L SelectBag concentrate flow/dialysis fluid flow Tech. data and specifications - AK 200™ ULTRA S dialysis machine HCEN9297 Revision 10.2012 Ultrafiltration Dialysis fluid flow operating range UF rate measurement UF rate supervision, max allowed difference between control and protective system, can be preset (Default) Accumulated UF volume alarm limit, can be preset (Default) Treatment Time Control TMP supervision alarm Max UF rate alarm limit, can be preset (Default) 300 - 700 ml/min -4.0 to +4.0 l/h (±2 ml/min) Accuracy ±5 ml/min verified at start-up. ±1-10 ml/min, (± 5 ml/h) ±200 ml, or ±70 - 130 ml/h (± 130 ml/h) * passed treatment time (h), whichever is greatest. 0.05 to 9.59 hour.minute (±1 minute) -200 to +550 mmHg (±15 mmHg) For AK 200 ULTRA S dialysis machine, TMP is defined as Pb out - Pd out + Offset, where Pb out is the venous drip chamber pressure and Pd out is the pressure measured in the dialysis fluid, where it enters the machine after the dialyzer. The offset compensates for the vertical distance between the pressure sensors. 0.1 to 4.0 l/h (1.0 l/h) In TMP on-line mode with settable substitution fluid volume only. Blood leak detection Sensitivity Alarm response time (diffusion mode) ≥0.15 ml blood/min at 300 ml/min dialysis fluid flow rate ≥0.35 ml blood/min at 700 ml/min dialysis fluid flow rate haematocrit 32% ±2% 7 seconds Blood loss due to coagulation Supervision of blood pump 10 to 180 seconds (60 seconds) stop time (Default) HCEN9297 Revision 10.2012 Tech. data and specifications - AK 200™ ULTRA S dialysis machine 8:17 Physical data Depth Width Total Height Floor Area Weight Blood Monitor Weight Fluid Monitor Weight Stand Total Weight Infusion Stand Height Transportation Approx. 610 mm Approx. 570 mm Adjustable heights 1175 - 1340 mm Five position stand 1152 - 1382 mm 573 x 753 mm Approx. 17 kg Approx. 40 kg Approx. 24 to 31 kg Approx. 81 to 88 kg 1300 to 2150 mm Max. load 10 kg One man installation Fitting into a normal Estate car References Assembly Drawing: K22200 8:18 Tech. data and specifications - AK 200™ ULTRA S dialysis machine HCEN9297 Revision 10.2012 Materials in contact with water, concentrates and dialysis fluid Polymers Silicon rubber Santroprene PVC (Polyvinylchloride) PEEK (Polyetherketone) PEX (Polyethylene) PP (Polypropylene) PP (Polypropylene reinforced with talcum) PSU (Polysulphone) PVDF (Polyvinylidene fluoride) PTFE (Polytetrafluoro ethylene) Parylene C Metals Stainless steel SS2343 Stainless steel SS2353 Stainless steel SS2562 Titanium Platinum Others Carbon Ceramic, Steatite 221 Ceramic, Aluminum oxide (Al2O3) Ceramic, Zirconium oxide (ZrO2) Glass Barium Ferrite HCEN9297 Revision 10.2012 Tech. data and specifications - AK 200™ ULTRA S dialysis machine 8:19 Environmental data Operation If condensation occur when moving the equipment between locations with different temperatures and high relative humidity (e.g. outdoor and indoor locations), the inside of the equipment shall be allowed to dry before switching on the equipment. Ambient Temperature range Relative Humidity range Air Pressure range (atm. pressure) Maximum altitude +18 to +35 °C 15 to 85% RH 700 to 1060 hPa ≈ 2000 m above sea level Transportation and storage During transportation and storage the equipment has to be kept in its original packing. If transportation or storage time is more than 15 weeks, the environmental data relating to the operation has to be followed. The maximum ambient temperature for transportation and storage in 96% Relative humidity is +40 °C. Ambient Temperature range Relative Humidity range Air Pressure range (atm. pressure) Maximum altitude -20 to +70 °C 10 to 96% RH 500 to 1060 hPa ≈ 2000 m above sea level Energy Typical energy consumption for a 4 hour treatment with inlet water temperature of 5 °C and 500 ml/h main flow is 2.7 kWh. Energy delivery to the environment is approximately 400 Wh independent of inlet water temperature. Energy delivery to the drain during a 4 hour treatment is 2.3 kWh. The temperature at the drain can be up to 80 °C. Power consumption and delivery to the drain decrease with approximately 19 W for every degree increase of inlet water temperature. 8:20 Tech. data and specifications - AK 200™ ULTRA S dialysis machine HCEN9297 Revision 10.2012 Electromagnetic environment The AK 200 ULTRA S dialysis machine is intended for use in the electromagnetic environment specified below. The customer or the user of the AK 200 ULTRA S dialysis machine should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment – guidance RF emissions CISPR 11 Group 1 The AK 200 ULTRA S dialysis machine uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class B The AK 200 ULTRA S dialysis machine is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes Harmonic emissions IEC 61000-3-2 Class A (Not applicable for 115 V version) Voltage fluctuations /flicker emissions IEC 61000-3-3 Complies (Not applicable for 115 V version) HCEN9297 Revision 10.2012 Tech. data and specifications - AK 200™ ULTRA S dialysis machine 8:21 Immunity test IEC 60601 test level Compliance level Electromagnetic environment-guidance Electrostatic discharge (ESD), IEC 61000-4-2 ±6 kV contact ±8 kV Air ±6 kV contact ±8 kV Air Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %. Electrical fast transient/burst, IEC 61000-4-4 ±2 kV for power lines ±1kV for input/output lines ±2 kV for power lines ±1kV for input/output lines Mains power quality should be that of a typical commercial or hospital environment. Surge IEC 61000-4-5 ±1kV for differential mode ±2kV for common mode ±1kV for differential mode ±2kV for common mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips, short interruptions and voltage variations on power supply input lines. IEC 61000-4-11 <5 % UT (>95 % dip in UT) for 0.5 cycle 40 % UT (60 % dip in UT) for 5 cycles 70 % UT (30 % dip in UT) for 25 cycles <5 % UT (>95 % dip in UT) for 5 sec <5 % UT (>95 % dip in UT) for 0.5 cycle 40 % UT (60 % dip in UT) for 5 cycles 70 % UT (30 % dip in UT) for 25 cycles <5 % UT (>95 % dip in UT) for 5 sec Mains power quality should be that of a typical commercial or hospital environment. If the user of the AK 200 ULTRA S dialysis machine requires continued operation during power mains interruptions, it is recommended that the AK 200 ULTRA S dialysis machine be powered from an uninterruptible power supply or a battery. Power frequency (50/60 Hz) magnetic field IEC 61000-4-8 3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. Note • UT is the a.c. mains voltage prior to application of the test level. Note 8:22 Tech. data and specifications - AK 200™ ULTRA S dialysis machine HCEN9297 Revision 10.2012 Immunity test IEC 60601 test level Compliance level Electromagnetic enviroment-guidance Portable and mobile RF communications equipment should be used no closer to any part of the AK 200 ULTRA S dialysis machine, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance Conducted RF IEC 61000-4-6 3 Vrms 150 kHz to 80 MHz 3V Radiated RF IEC 61000-4-3 3 V/m 80 MHz to 2.5 GHz 3 V/m Radiated RF mobile phones - 30V/m 80 MHz to 800 800 MHz to 2.5 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey3, should be less than the compliance level in each frequency range4. Interference may occur in the vicinity of equipment marked with the following symbol: Note • At 80 MHz and 800 MHz, the higher frequency range applies. • These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Note 3 Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the AK 200 ULTRA S dialysis machine is used exceeds the applicable RF compliance level above, the AK 200 ULTRA S dialysis machine should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the AK 200 ULTRA S dialysis machine. 4 Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. HCEN9297 Revision 10.2012 Tech. data and specifications - AK 200™ ULTRA S dialysis machine 8:23 Recommended separation distances between portable and mobile RF communications equipment and the AK 200 ULTRA S dialysis machine The AK 200 ULTRA S dialysis machine is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the AK 200 ULTRA S dialysis machine can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the AK 200 ULTRA S dialysis machine as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter W Separation distance according to frequency of transmitter (m) 150kHz - 80MHz 80MHz - 800MHz 800MHz - 2500MHz 0.01 0.11 0.11 0.23 0.1 0.37 0.37 0.74 1 1.2 1.2 2.3 10 3.7 3.7 7.4 100 12 12 23 Rated maximum output power of mobile phone - - 2W GSM/3G - - 0.33 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. Note • At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. • These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Note 8:24 Tech. data and specifications - AK 200™ ULTRA S dialysis machine HCEN9297 Revision 10.2012 Standards The machine complies with the following standards: IEC 60601-1 General requirements for safety, Class I, type B IEC 60601-2-16 Particular requirements for safety of haemodialysis, haemodiafiltration and haemofiltration equipment IEC 60601-2-30 Particular requirements for the safety of automatic cycling indirect blood pressure monitoring equipment IEC 60601-1-2 Electromagnetic compatibility EN 1060-1 Non-invasive sphygmomanometers Part 1: General requirements EN 1060-3 Non-invasive sphygmomanometers Part 3: Supplementary requirements for electromechanical blood pressure measuring systems NFS 90-304 Medico-surgical equipment Hemodialysis equipment HCEN9297 Revision 10.2012 Tech. data and specifications - AK 200™ ULTRA S dialysis machine 8:25 This page is intentionally left blank 8:26 Tech. data and specifications - AK 200™ ULTRA S dialysis machine HCEN9297 Revision 10.2012 Chapter 9 Electrical safety inspection Contents General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9:2 Visual inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9:4 PET - Protective Earth Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9:5 Test equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9:5 for AK 95® / AK 95® S dialysis machines . . . . . . . . . . . . . . . . 9:5 for AK 96® dialysis machine . . . . . . . . . . . . . . . . . . . . . . . . . . 9:6 for AK 200™ / AK 200™ ULTRA / AK 200™ S / AK 200™ ULTRA S dialysis machines . . . . . . . . . . . . . . . . . . . 9:7 ELT / PLT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9:8 Test equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9:8 General conditions for ELT / PLT . . . . . . . . . . . . . . . . . . . . . . . 9:8 ELT - Earth Leakage Current Test . . . . . . . . . . . . . . . . . . . . . . . 9:9 PLT - Patient Leakage Current Test . . . . . . . . . . . . . . . . . . . . . . 9:10 Record of Electrical Safety Inspection . . . . . . . . . . . . . . . . . . . . . . . . 9:12 HCEN12190 Revision 10.2012 Electrical safety inspections 9:1 General To ensure proper operation, a qualified service technician shall perform an Electrical Safety Inspection (ESI) of the dialysis machine at regular intervals. ESI should be performed at every maintenance service (Base-service) but also after replacements of some components in the dialysis machine according to the Service Manual, chapter Replacements. Additionally if the equipment has been exposed to unexpected electrical events on the main supply or unintentional ingress of fluid has occurred, a full Electrical Safety Inspection shall be performed. The information needed to perform ESI is provided in this instruction. Included in the ESI procedures are checks to verify normal machine operation. Should the machine fail to pass any of these sub-tests, repair or calibration might be needed, then repeat the tests until the specifications are met. Following sub-tests are included in the ESI of the dialysis machines: • Visual inspection • PET - Protective earth test • ELT - Earth leakage current test • PLT - Patient leakage current test To avoid premature aging of isolation material no insulation test shall be performed during ESI. Spare parts dependent on insulation are tested at manufacturing and therefore no further test shall be performed with high voltage. During the visual inspection of the equipment, the service engineer shall look for potential faults related to the electrical safety of the machine. The purpose of the PET test is to verify that the protective earthed parts of the machine are properly connected to protective earth, providing a safe low electrical potential on these in case of insulation failure. The purposes of the ELT/PLT tests are to verify that non-functional leakage currents to operator and patient are within safe limits. When performing the ESI, which requires access to the interior of the machine, the service technician shall have proper electrostatic safety devices (i.e. wrist grounding straps or grounding mats) in place to prevent damage to electrostatic sensitive components within the machine. During repair of any of the parts in the flow path, special care should be taken and a good hygiene should be kept. Records for each sub-test are included in the end of this instruction. The purpose of these records is to document the work done and to trend the readings from the tests. 9:2 Electrical safety inspections HCEN12190 Revision 10.2012 Note • If the machine is tested according to IEC 60601-11, this complies with the requirements in IEC 623532. Note 1 IEC 60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. 2 IEC 62353: Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment. HCEN12190 Revision 10.2012 Electrical safety inspections 9:3 Visual inspection The visual inspection is an important part of the electrical safety inspections of the dialysis machine. The visual inspection is a procedure to make sure that the medical equipment in use still confirms the specifications and has not suffered from any external damage and/or contamination. The visual inspection includes following steps: 1. Exterior parts including covers: look for major damages, cracks etc. 2. Cabling: look for cuts, wrong connections etc. 3. Fuse rating: check correct values after replacement. 4. Markings and labelling: check the integrity. 5. Integrity of mechanical parts: check for any visual obstructions. 9:4 Electrical safety inspections HCEN12190 Revision 10.2012 PET - Protective Earth Test Note • The machine shall not be connected to mains power during this test. • Limit values for PET-test according to IEC 62353. Note Test equipment According to IEC 62353 for AK 95® / AK 95® S dialysis machines Check that the resistance between the protective earth connection of the mains plug and... 1. ...the exterior cover of the power supply... 2. ...the heater rod... 3. ...the suction pump... 4. ...the mounting plate to the Diascan system conductivity cell... 5. ...the stand of MM 95 (e.g. a screw to the heat exchangers)... 6. ...the front of MM 95 (e.g. a screw to the BiCart cartridge holder)... 7. ...the heparin pump (rear plate)... 8. ...the potential equalization connector... ...does not exceed 300 mΩ. HCEN12190 Revision 10.2012 Electrical safety inspections 9:5 for AK 96® dialysis machine Check that the resistance between the protective earth connection of the mains plug and... 1. ...the exterior cover of the power supply... 2. ...the heater rod... 3. ...the mounting plate for the suction pump, measure on one of the screws, ... 4. ...the mounting plate for the flow pump, measure on one of the screws, ... 5. ...the mounting plate to the safety couplings for the dialysis fluid tubes... 6. ...the pressure regulator, PR1, ... 7. ...the mounting plate to the water inlet/drain-nipples, measure on one of the screws, ... 8. ...the mounting plate to the external communication port, measure on one of the screws, ... 9. ...the mounting plate to the potential equalization connector, measure on one of the screws, ... 10. ...the potential equalization connector... 11. ...the heparin pump (rear plate)... ...does not exceed 300 mΩ. 9:6 Electrical safety inspections HCEN12190 Revision 10.2012 for AK 200™ / AK 200™ ULTRA / AK 200™ S / AK 200™ ULTRA S dialysis machines Check that the resistance between the protective earth connection of the mains plug and... 1. ...the power supply (right side, through the vent holes of the bottom box)... 2. ...the FM bottom plate... 3. ...the heater rods outside the heating vessel... 4. For 115 V machines: Also check that the resistance between the protective earth connection of the mains plug for the heater rods and the heater rods outside the heating vessel... 5. ...the overheat protection of the heater rods... 6. ...the potential equalization connector... 7. ...the heparin pump (rear plate, do not measure on the cable clip or its binding screw)... 8. ...the rear plate of the BVS unit... ...does not exceed 300 mΩ. HCEN12190 Revision 10.2012 Electrical safety inspections 9:7 ELT / PLT Test equipment • Safety Tester, set to measure according to IEC 60601-1. • PLT box K40246001. General conditions for ELT / PLT 1. The dialysis machine shall be connected to both feed water and drain. 2. Perform the test with all enclosure parts of the machine assembled. 3. Connect the dialysis machine to the outlet supply of the safety tester. Use a mains plug adapter for respective mains plug. If the dialysis machine is equipped with two mains plugs, the measurements shall be performed for each mains plug and the values shall be added. Note • To avoid damages on the safety tester, follow the instructions for the safety tester. Note 4. Central concentrate delivery systems should not be used. Use either liquid or non-liquid concentrates. 5. No other external equipment than specified in this instruction should be connected to the machine. 6. The protective earth of the machine shall not be in contact with any external protective earth. 7. No Potential Equalization cable shall be connected during test. In the case of several machines are connected together in a system the sum of each machine ELT and PLT values shall be less than the maximum values shown in the tables. 9:8 Electrical safety inspections HCEN12190 Revision 10.2012 ELT - Earth Leakage Current Test 1. Let the machine pass FCH. 2. Measure the earth leakage current with the safety tester. Measure both in N.C. (Normal Condition) and S.F.C. (Single Fault Condition). 3. Take the highest reading when the machine is running. 4. Invert the phases of the mains voltage. The machine might restart. 5. Take the highest reading when the machine is running. Measure both in N.C. (Normal Condition) and S.F.C. (Single Fault Condition). 6. Check that the highest measured readings do not exceed the limit values in the table “Limit values for earth leakage current (ELT)”. Limit values for earth leakage current (ELT) ELT Limit values N.C. S.F.C. Max 500 µA Max 1000 µA AK 95 S (100 V, 110 V) AK 96 (115 V) AK 200 S (115 V)3 AK 200 ULTRA S (115 V)3 AK 95 S, AK 96 (230 V) AK 200 S (230 V) AK 200 ULTRA S (230 V) 3 The total earth leakage current is the sum of the readings from both mains cables (to the heater rods and to the ACDC). HCEN12190 Revision 10.2012 Electrical safety inspections 9:9 PLT - Patient Leakage Current Test Note • Make sure that the machine does not perform a taration (self-calibration) during the measurements. Note 1. Let the machine pass FCH. 2. Connect the dialysis fluid tubes to the PLT box. 3. The access point on the PLT box shall be connected to the Safety Tester. 4. There must be a fluid flow during this test. Make sure that the fluid is not in bypass. 5. Measure the patient leakage current with the safety tester. Follow the user manual for the safety tester. 6. Measure both in N.C. (Normal Condition) and S.F.C. (Single Fault Condition). 7. Take the highest AC-reading when the machine is running. 8. Take the highest DC-reading when the machine is running. 9. Invert the phases of the mains voltage. The machine may restart. 10. Measure both in N.C. (Normal Condition) and S.F.C. (Single Fault Condition). 11. Take the highest AC-reading when the machine is running. 12. Take the highest DC-reading when the machine is running. 13. Check that the highest measured readings do not exceed the limit values in the table “Limit values for patient leakage current (PLT).”. 9:10 Electrical safety inspections HCEN12190 Revision 10.2012 Limit values for patient leakage current (PLT). PLT Limit values AC N.C. DC N.C. AC S.F.C. DC S.F.C. Max 100* µA Max 10 µA Max 500 µA Max 50 µA AK 95 S (100 V, 110 V) AK 96 (115 V) AK 200 S (115 V)4 AK 200 ULTRA S (115 V)4 AK 95 S, AK 96 (230 V) AK 200 S (230 V) AK 200 ULTRA S (230 V) Note *For treatments with a central venous catheter (CVC), the patient leakage current shall be < 10μA AC at Normal Condition (N.C.). Note 4 HCEN12190 Revision 10.2012 The total patient leakage current is the sum of the readings from both safety testers. Electrical safety inspections 9:11 Record of Electrical Safety Inspection Machine type AK 95 AK 96 AK 200 AK 200 S □ □ □ □ AK 95 S AK 200 ULTRA AK 200 ULTRA S □ □ □ Machine identification Product code Serial number Run time (h) Visual inspection Description Approved check A visual inspection of the AK-machine has been performed without any remarks, according to the specified step instruction in section "Visual inspection". □ Remarks: ______________________________________________________ ______________________________________________________ ______________________________________________________ ______________________________________________________ 9:12 Electrical safety inspections HCEN12190 Revision 10.2012 PET for AK 95® / AK 95® S dialysis machines Check no Description Measured value Approved check Check that the resistance between the protective earth connection of the mains plug and... 1 ...the exterior cover of the power supply... ……. mΩ 2 ...the heater rod... ……. mΩ 3 the suction pump... ……. mΩ 4 ...the mounting plate to the Diascan system conductivity cell... ……. mΩ □ □ □ □ 5 ...the stand of MM 95 (e.g. a screw to the heat exchangers)... ……. mΩ □ 6 ...the front of MM 95 (e.g. a screw to the BiCart cartridge holder)... ……. mΩ 7 ...the heparin pump (rear plate)... ……. mΩ □ □ 8 ...the potential equalization connector... ……. mΩ □ ...does not exceed 300 mΩ. HCEN12190 Revision 10.2012 Electrical safety inspections 9:13 PET for AK 96® dialysis machine Check no Description Measured value Approved check Check that the resistance between the protective earth connection of the mains plug and... 1 ...the exterior cover of the power supply... ……. mΩ 2 ...the heater rod... ……. mΩ □ □ 3 ...the mounting plate for the suction pump, measure on one of the screws, ... ……. mΩ □ 4 ...the mounting plate for the flow pump, measure on one of the screws, ... ……. mΩ □ 5 ...the mounting plate to the safety couplings for the dialysis fluid tubes... ……. mΩ 6 ...the pressure regulator, PR1, ... ……. mΩ □ □ 7 ...the mounting plate to the water inlet/drain-nipples, measure on one of the screws, ... ……. mΩ □ 8 ...the mounting plate to the external communication port, measure on one of the screws, ... ……. mΩ □ 9 ...the mounting plate to the potential equalization connector, measure on one of the screws, ... ……. mΩ □ 10 ...the potential equalization connector... ……. mΩ 11 ...the heparin pump (rear plate)... ……. mΩ □ □ ...does not exceed 300 mΩ. 9:14 Electrical safety inspections HCEN12190 Revision 10.2012 PET for AK 200™ / AK 200™ ULTRA / AK 200™ S / AK 200™ ULTRA S dialysis machines Check no Description Measured value Approved check □ Check that the resistance between the protective earth connection of the mains plug and... 1 ...the power supply (right side, through the vent holes of the bottom box)... ……. mΩ 2 ...the FM bottom plate... ……. mΩ 3 ...the heater rods outside the heating vessel... ……. mΩ □ □ 4 For 115 V machines: Check that the resistance between the protective earth connection of the mains plug for the heater rods and the heater rods outside the heating vessel... ……. mΩ □ 5 ...the overheat protection of the heater rods... ……. mΩ □ 6 ...the potential equalization connector... ……. mΩ □ 7 ...the heparin pump (rear plate, do not measure on the cable clip or its binding screw)... ……. mΩ □ 8 ...the rear plate of the BVS-unit... ……. mΩ □ ...does not exceed 300 mΩ. HCEN12190 Revision 10.2012 Electrical safety inspections 9:15 ELT - Earth Leakage Current Test Description Measured value Approved check File the highest measured earth leakage current, normal condition (N.C.) reading according to section “ELT - Earth Leakage Current Test”, in this chapter. ……. µA □ File the highest measured earth leakage current, single fault condition (S.F.C.) reading according to section “ELT - Earth Leakage Current Test”, in this chapter. ……. µA □ PLT - Patient Leakage Current Test File both the highest AC-reading and the highest DC-reading when the machine is running according to the section PLT - Patient Leakage Current Test, in this chapter. Description Measured value Approved check File the highest measured patient leakage current, normal condition (N.C.) reading according to section “PLT - Patient Leakage Current Test” in this chapter. ……. µA DC ……. µA AC □ □ File the highest measured patient leakage current, single fault condition (S.F.C.) reading according to section “PLT - Patient Leakage Current Test” in this chapter. ……. µA DC ……. µA AC □ □ Compare with the measured leakage currents at the last5 ESI and evaluate if the changes are approved or not for the next operational period of the machine. Write notes here: _____________________________________________________ _____________________________________________________ _____________________________________________________ Name of testing organization Date Name of testing Service engineer Signature This record is to be signed and filed by the Service Engineer responsible for the electrical safety inspection 5 If this is the ESI at installation please make comparison with the ”Production Summary” measured values supplied by the manufacturer at delivery of the machine. 9:16 Electrical safety inspections HCEN12190 Revision 10.2012 Chapter 10 Wiring diagram HCEN12190 Revision 10.2012 10:1 This page is intentionally left blank 10:2 HCEN12190 Revision 10.2012 Chapter 11 Calibration manual Contents General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ................................................... Calibration, Fluid Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ................................................... Technical Facilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A/D Converter FM (CPU Q), FM 21 . . . . . . . . . . . . . . . . . . . . A/D Converter FM (CPU F;1), FM 22 . . . . . . . . . . . . . . . . . . . A/D Converter FM (CPU F;2), FM 23 . . . . . . . . . . . . . . . . . . . Temperature FM CPU Board calibration, FM 0 . . . . . . . . . . . . . Degassing Transducer calibration, FM 7 . . . . . . . . . . . . . . . . . . Flow Output Pressure Transducer calibration, FM 8 . . . . . . . . . Flow Input Pressure Transducer calibration, FM 9 . . . . . . . . . . High Pressure Guard Transducer calibration, FM 10 . . . . . . . . . Dialysis Fluid Pressure Transducer (PD) calibration, FM 11 . . . Safety Guard Pressure Transducer calibration, FM 12 . . . . . . . . pH-sensor calibration, FM 13 . . . . . . . . . . . . . . . . . . . . . . . . . . Blood Leakage Detector calibration, FM 24 . . . . . . . . . . . . . . . Internal pressure regulator calibration . . . . . . . . . . . . . . . . . . . . Inlet pressure regulator adjustment . . . . . . . . . . . . . . . . . . . . . . Conductivity Transducer calibration, FM 20 - with liquid concentrate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Conductivity Transducer calibration, FM 20 - with SelectCart cartridge . . . . . . . . . . . . . . . . . . . . . . . . . . . . BiCart SelectⓇ - Level detector calibration . . . . . . . . . . . . . . . . BiCart SelectⓇ - control and protective pump calibration . . . . . Calibration of Flow Restrictor Node (FRN) main flow supervision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Automatic UF calibration/Supervision flow meter calibration . . Calibration, Blood Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ................................................... A/D Converter BM (CPU P), BM 4 . . . . . . . . . . . . . . . . . . . . . Venous Pressure Transducer calibration, BM 3 . . . . . . . . . . . . . Arterial Pressure Transducer calibration, BM 2 . . . . . . . . . . . . . System Pressure Transducer calibration, BM 1 . . . . . . . . . . . . . Level Detector calibration (Air detector), BM 5 . . . . . . . . . . . . Priming Detector calibration, BM 6 . . . . . . . . . . . . . . . . . . . . . Blood Volume Sensor - BVS . . . . . . . . . . . . . . . . . . . . . . . . . . Temperature BM CPU Board calibration, BM 0 . . . . . . . . . . . . Occlusion adjustment, blood pump/substitution flow pump . . . . BPM test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Logging after calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ................................................... Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Logging values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . HCEN12089 Revision 10.2012 Calibration manual 11:2 11:2 11:3 11:3 11:3 11:4 11:5 11:6 11:7 11:8 11:10 11:12 11:14 11:16 11:18 11:20 11:23 11:24 11:25 11:26 11:28 11:30 11:33 11:37 11:41 11:45 11:45 11:45 11:46 11:48 11:50 11:52 11:54 11:55 11:55 11:56 11:57 11:61 11:61 11:61 11:61 11:1 General Guidelines for the AK 200 S / AK 200 ULTRA S dialysis machine, related to Service and Maintenance: • During transportation and storage: AK 200 S / AK 200 ULTRA S dialysis machine must for practical reasons be rinsed and drained, however, as soon as the machine is installed, the disinfection schedule should be followed. • During repair of any of the parts in the flow path, special care should be taken and a good hygiene should be kept. • Used and repaired spare parts may be used in the AK 200 S / AK 200 ULTRA S dialysis machine if they are cleaned and repaired in a good way. • A general guide line is that the ultrafilters should be mounted on the AK 200 S / AK 200 ULTRA S dialysis machine as well as the disinfection schedule should be followed, as soon as the machine is connected to the water supply. WARNING After completing the check and calibrations, the conductivity value must always be confirmed by the hospital laboratory or equivalent. WARNING Before calibration Perform: 1. A decalcification to remove calcium precipitates. 2. A disinfection to remove organic residuals. For details, refer to the AK 200 S / AK 200 ULTRA S Operator’s Manual. This is not necessary if this has been done during maintenance. 11:2 Calibration manual HCEN12089 Revision 10.2012 Calibration, Fluid Monitor Technical Facilities The following instructions are based on the availability of some technical facilities, listed below. Test equipment: Tolerance: Manufacturer: Conductivity measurement ±0.1 mS/cm MESA, IBP ±2 mmHg within ±200 mmHg MESA, IBP, Druck Pressure measurement Gambro Order number: ±1% beyond ±200 mmHg If BPM is installed: ±0.8 mmHg UF calibration station Gambro K21908002 Temperature measurement: ±0.2 ºC MESA, IBP Digital Voltmeter ±0.5% Fluke Measuring glass ±5 ml Any Blood leakage Calibration Cover N/A Gambro K40169001 Gauge pin kit for blood pump T = 1.1 (Stop pin = 1.1 x 2 x 0.7 = 1.5 mm) Gambro K40158001 rollers (including three different T = 1.6 (Stop pin = 1.6 x 2 x 0.7 = 2.2 mm) pins) T = 2.0 (Stop pin = 2.0 x 2 x 0.7 = 2.8 mm) Gambro K40158002 T = wall thickness of the blood tubing Gauge pin kit for blood pump T = 1.1 (Stop pin = 1.1 x 2 x 0.7 = 1.5 mm) rollers (to be ordered separately) T = 1.6 (Stop pin = 1.6 x 2 x 0.7 = 2.2 mm) K40158003 T = 2.0 (Stop pin = 2.0 x 2 x 0.7 = 2.8 mm) K40158004 T = wall thickness of the blood tubing Calibration tube kit N/A Gambro K13983002 Drip chamber N/A Gambro N/A Tube for calibration of priming N/A Gambro N/A detector Safety tester According to IEC 60601-1 Rigel, Biotec, Metron, Fluke BPM test equipment (if installed) N/A Gambro K22151001 BPM Cuff (if installed) N/A Gambro 110350 pH buffers (if installed) ±0.07 pH units Any pH 7 – 100810001 pH 9 – 100810002 BVS test tool N/A Gambro K22281001 Magnet for blood pump cover N/A Gambro K19049002 Measuring cylinder N/A Gambro K22349001 Gambro K40246001 Leakage current access point, PLT box HCEN12089 Revision 10.2012 Calibration manual 11:3 A/D Converter FM (CPU Q), FM 21 Equipment needed Digital voltmeter 1. Start the AK 200 S / AK 200 ULTRA S dialysis machine and enter the service menu, Calibr / FM / Extern. 2. Set the display to: 3. Press the Start UF Stop button to enter calibration routine. 4. Measure the voltage between TP 3 (earth) and TP 1 (ref) on the FM CPU board. (See figure below.) 5. Set the REF SET on the display to the value shown on the voltmeter (min. 48.96 mV max. 50.88 mV). Press the Arrow button to confirm. 6. Press the Start UF Stop button to load the value into the EEPROM. 11:4 Calibration manual HCEN12089 Revision 10.2012 A/D Converter FM (CPU F;1), FM 22 Equipment needed Digital voltmeter 1. Start the AK 200 S / AK 200 ULTRA S dialysis machine and enter the service menu, Calibr / FM / Extern. 2. Set the display to: 3. Press the Start UF Stop button to enter calibration routine. 4. Measure the voltage between TP 10 (earth) and TP 8 (ref) on the FM CPU board. (See figure below.) 5. Set the REF SET on the display to the value shown on the voltmeter (min. 48.96 mV max. 50.88 mV). Press the Arrow button to confirm. 6. Press the Start UF Stop button to load the value into the EEPROM. HCEN12089 Revision 10.2012 Calibration manual 11:5 A/D Converter FM (CPU F;2), FM 23 Equipment needed Digital voltmeter 1. Start the AK 200 S / AK 200 ULTRA S dialysis machine and enter the service menu, Calibr / FM / Extern. 2. Set the display to: 3. Press the Start UF Stop button to enter calibration routine. 4. Measure the voltage between TP 5 (earth) and TP 2 (ref) on the FM CPU board. (See figure below) 5. Set the REF SET on the display to the value shown on the voltmeter (min. 48.96 mV max. 50.88 mV). Press the Arrow button to confirm. 6. Press the Start UF Stop button to load the value into the EEPROM. 11:6 Calibration manual HCEN12089 Revision 10.2012 Temperature FM CPU Board calibration, FM 0 Equipment needed Temperature meter 1. Remove the rear cover of the FM. 2. Make sure AK 200 S / AK 200 ULTRA S dialysis machine has been switched off for at least 30 min. without being moved (to assure room temperature on the FM CPU board). Also make sure the reference instrument transducer has been in room temperature at least 30 minutes. 3. Start the AK 200 S / AK 200 ULTRA S dialysis machine, enter the service menu, Calibr / FM / Extern and set the display to: 4. Press the Start UF Stop button to enter calibration routine. 5. Read the room temperature on a Temperature meter and set the REF SET value on the AK 200 S / AK 200 ULTRA S dialysis machine display to the same value. 6. Press the lit Arrow button below REF SET to enter the value and wait for the calibration display. 7. Press the Start UF Stop button to load the value into the EEPROM. Note • Calibrations of temperature transducers in heating vessel or conductivity cell need special equipment and can only be performed at Gambro Lundia AB, Lund. Note HCEN12089 Revision 10.2012 Calibration manual 11:7 Degassing Transducer calibration, FM 7 (Tolerance ±5 mmHg or ±3%) Equipment needed Pressure reference instrument, Calibration tube set. 1. Start the AK 200 S / AK 200 ULTRA S dialysis machine and let it run with fluid for 30 minutes. 2. Initiate drain. When the Rinse/Drain button starts to flash, enter the service menu, Calibr / FM / Extern. 3. Set the display to: 4. Press the Start UF stop button to enter the calibration routine. 5. Disconnect the degassing pressure transducer from the degassing pump. Connect a straight silicone connector and insert a plug (from the calibration kit) according to the figure below (1). 6. Connect Gambro reference instrument to the silicone connector according to the figure below (2). 7. Apply zero pressure by opening the three clamps A, B and C on the calibration tube set. 8. Set the REF SET value on the display to 0 mmHg (with the Set knob). 9. Press the Arrow button below REF SET to enter the value and wait for the calibration display. 11:8 Calibration manual HCEN12089 Revision 10.2012 10. Close clamp A. Apply a pressure of approx. -500 mmHg, shown on the reference instrument. Close clamp B. 11. Set the REF SET value on the AK 200 S / AK 200 ULTRA S dialysis machine display to the same value as shown on the reference instrument. 12. Press the Arrow button below REF SET to enter the value and wait for the calibration display. 13. The machine will now ask you to confirm to enter sensitivity calibration. To confirm: press the Arrow button below Yes. 14. Open clamp A and B, then close clamp A again. Apply a pressure of approx. +500 mmHg, shown on the reference instrument. Close clamp B. 15. Set the REF SET value on the AK 200 S / AK 200 ULTRA S dialysis machine display to the same value as shown on the reference instrument. 16. Press the Arrow button below REF SET to enter the value and wait for the calibration display. 17. Press the Start UF Stop button to load the value into the EEPROM. 18. Reconnect the fluid path to its original design after the calibration. 19. To exit from the Calibration routine, press the Hold button. 20. Always perform a Heat disinfection after the fluid path has been opened. Note • *If an error message is shown on the display at this point, press the Hold button and start again from step 4. If the error still exists after a second try, check that the calibration tubes are intact. If the tubes are correct, repeat the calibration procedure with a new transducer. Ex. of calibration error message: Note HCEN12089 Revision 10.2012 Calibration manual 11:9 Flow Output Pressure Transducer calibration, FM 8 (Tolerance ±5 mmHg or ±3%) Equipment needed Pressure reference instrument, Calibration tube set. 1. Start the AK 200 S / AK 200 ULTRA S dialysis machine and let it run with fluid for 30 minutes. 2. Initiate drain. When the Rinse/Drain button starts to flash, enter the service menu, Calibr / FM / Extern. 3. Set the display to: 4. Press the Start UF stop button to enter the calibration routine. 5. Disconnect the flow output pressure transducer from the flow output pump. Connect a straight silicone connector and insert a plug (from the calibration kit) according to the figure below (1). 6. Connect Gambro reference instrument to the silicone connector according to the figure below (2). 7. Apply zero pressure by opening the three clamps A, B and C on the calibration tube set. 8. Set the REF SET value on the display to 0 mmHg (with the Set knob). 9. Press the Arrow button below REF SET to enter the value and wait for the calibration display. 11:10 Calibration manual HCEN12089 Revision 10.2012 10. Close clamp A. Apply a pressure of approx. -500 mmHg, shown on the reference instrument. Close clamp B. 11. Set the REF SET value on the AK 200 S / AK 200 ULTRA S dialysis machine display to the same value as shown on the reference instrument. 12. Press the Arrow button below REF SET to enter the value and wait for the calibration display. 13. The machine will now ask you to confirm to enter sensitivity calibration. To confirm: press the Arrow button below Yes. 14. Open clamp A and B, then close clamp A again. Apply a pressure of approx. +500 mmHg, shown on the reference instrument. Close clamp B. 15. Set the REF SET value on the AK 200 S / AK 200 ULTRA S dialysis machine display to the same value as shown on the reference instrument. 16. Press the Arrow button below REF SET to enter the value and wait for the calibration display. 17. Press the Start UF Stop button to load the value into the EEPROM. 18. Reconnect the fluid path to its original design after the calibration. 19. To exit from the Calibration routine, press the Hold button. 20. Always perform a Heat disinfection after the fluid path has been opened. Note • *If an error message is shown on the display at this point, press the Hold button and start again from step 4. If the error still exists after a second try, check that the calibration tubes are intact. If the tubes are correct, repeat the calibration procedure with a new transducer. Ex. of calibration error message: Note HCEN12089 Revision 10.2012 Calibration manual 11:11 Flow Input Pressure Transducer calibration, FM 9 (Tolerance ±5 mmHg or ±3%) Equipment needed Pressure reference instrument, Calibration tube set. 1. Start the AK 200 S / AK 200 ULTRA S dialysis machine and let it run with fluid for 30 minutes. 2. Initiate drain. When the Rinse/Drain button starts to flash, enter the service menu, Calibr / FM / Extern. 3. Set the display to: 4. Disconnect tube no. 32 at the EVVA valve and block tube no. 32 by using a closed tube. 5. Disconnect both end of tube no. K23473 at the pressure transducer unit. 6. Press the Start UF Stop button to enter calibration routine. 7. Set the REF SET value on the display to 0 mmHg (with the Set knob). 8. Press the lit Arrow button below REF SET to enter the value and wait for the calibration display. 9. Connect a Pressure reference instrument (together with a calibration tube) in the place of tube no. K23473 at the side of the pressure transducer unit that is connected to the flow input pump unit. 10. Apply zero pressure by opening the three clamps A, B and C on the calibration tube set. 11. Close clamp A. Apply a pressure of approx. +500 mmHg, shown on the reference instrument. Close clamp B. 12. Set the REF SET value on the AK 200 S / AK 200 ULTRA S dialysis machine display to the same value as shown on the Pressure reference instrument. 13. Press the lit Arrow button below REF SET to enter the value and wait for the calibration display. 14. The machine will now ask you to confirm to enter sensitivity calibration. To confirm: press the Arrow button below Yes. 15. Press the Start UF Stop button to load the value into the EEPROM. 11:12 Calibration manual HCEN12089 Revision 10.2012 16. Reconnect the fluid path to its original design after the calibration. 17. Always perform a Heat disinfection after the fluid path has been opened. HCEN12089 Revision 10.2012 Calibration manual 11:13 High Pressure Guard Transducer calibration, FM 10 (Tolerance ±5 mmHg or ±3%) Equipment needed Pressure reference instrument, Calibration tube set. 1. Start the AK 200 S / AK 200 ULTRA S dialysis machine and let it run with fluid for 30 minutes. 2. Initiate drain. When the Rinse/Drain button starts to flash, enter the service menu, Calibr / FM / Extern. 3. Set the display to: 4. Disconnect tube no. 19 at the bypass unit. 5. Connect Gambro reference instrument according to the figure below. 6. Apply zero pressure by opening the three clamps A, B and C on the calibration tube set. 7. Set the REF SET value on the display to 0 mmHg (with the Set knob). 8. Press the Arrow button below REF SET to enter the value and wait for the calibration display. 9. Close clamp A. Apply a pressure of approx. -500 mmHg, shown on the reference instrument. Close clamp B. 10. Set the REF SET value on the AK 200 S / AK 200 ULTRA S dialysis machine display to the same value as shown on the reference instrument. 11. Press the Arrow button below REF SET to enter the value and wait for the calibration display. 12. The machine will now ask you to confirm to enter sensitivity calibration. To confirm: press the Arrow button below Yes. 13. Open clamp A and B, then close clamp A again. Apply a pressure of approx. +500 mmHg, shown on the reference instrument. Close clamp B. 14. Set the REF SET value on the AK 200 S / AK 200 ULTRA S dialysis machine display to the same value as shown on the reference instrument. 15. Press the Arrow button below REF SET to enter the value and wait for the calibration display. 11:14 Calibration manual HCEN12089 Revision 10.2012 16. Press the Start UF Stop button to load the value into the EEPROM. 17. Reconnect the fluid path to its original design after the calibration. 18. To exit from the Calibration routine, press the Hold button. 19. Always perform a Heat disinfection after the fluid path has been opened. Note • *If an error message is shown on the display at this point, press the Hold button and start again from step 5. If the error still exists after a second try, check that the calibration tubes are intact. If the tubes are correct, repeat the calibration procedure with a new transducer. Ex. of calibration error message: Note HCEN12089 Revision 10.2012 Calibration manual 11:15 Dialysis Fluid Pressure Transducer (PD) calibration, FM 11 (Tolerance ±5 mmHg or ±3%) Equipment needed Pressure reference instrument, Calibration tube set. 1. Start the AK 200 S / AK 200 ULTRA S dialysis machine and let it run with fluid for 30 minutes. 2. Initiate drain. When the Rinse/Drain button starts to flash, enter the service menu, Calibr / FM / Extern. 3. Set the display to: 4. Press the Start UF stop button to enter the calibration routine. 5. Disconnect the carbon tube connector located on the inside of the dialysis fluid inlet (from the dialyzer). Note • Be careful - the carbon tube can easily be damaged. Pull the silicon connector straight up. Note 6. Connect Gambro reference instrument to the carbon tube connector according to the figure below. 7. Apply zero pressure by opening the three clamps A, B and C on the calibration tube set. 8. Set the REF SET value on the display to 0 mmHg (with the Set knob). 11:16 Calibration manual HCEN12089 Revision 10.2012 9. Press the Arrow button below REF SET to enter the value and wait for the calibration display. 10. Close clamp A. Apply a pressure of approx. -500 mmHg, shown on the reference instrument. Close clamp B. 11. Set the REF SET value on the AK 200 S / AK 200 ULTRA S dialysis machine display to the same value as shown on the reference instrument. 12. Press the Arrow button below REF SET to enter the value and wait for the calibration display. 13. The machine will now ask you to confirm to enter sensitivity calibration. To confirm: press the Arrow button below Yes. 14. Open clamp A and B, then close clamp A again. Apply a pressure of approx. +500 mmHg, shown on the reference instrument. Close clamp B. 15. Set the REF SET value on the AK 200 S / AK 200 ULTRA S dialysis machine display to the same value as shown on the reference instrument. 16. Press the Arrow button below REF SET to enter the value and wait for the calibration display. 17. Press the Start UF Stop button to load the value into the EEPROM. 18. Reconnect the fluid path to its original design after the calibration. 19. To exit from the Calibration routine, press the Hold button. 20. Always perform a Heat disinfection after the fluid path has been opened. Note • *If an error message is shown on the display at this point, press the Hold button and start again from step 4. If the error still exists after a second try, check that the calibration tubes are intact. If the tubes are correct, repeat the calibration procedure with a new transducer. Ex. of calibration error message: Note HCEN12089 Revision 10.2012 Calibration manual 11:17 Safety Guard Pressure Transducer calibration, FM 12 (Tolerance ±5 mmHg or ±3%) Equipment needed Pressure reference instrument, Calibration tube set. 1. Start the AK 200 S / AK 200 ULTRA S dialysis machine and let it run with fluid for 30 minutes. 2. Initiate drain. When the Rinse/Drain button starts to flash, enter the service menu, Calibr / FM / Extern. 3. Set the display to: 4. Press the Start UF stop button to enter the calibration routine. 5. Disconnect the safety guard pressure transducer. Connect a straight silicone connector and insert a plug (from the calibration kit) according to the figure below (1). 6. Connect Gambro reference instrument to the silicone connector according to the figure below (2). 7. Apply zero pressure by opening the three clamps A, B and C on the calibration tube set. 8. Set the REF SET value on the display to 0 mmHg (with the Set knob). 9. Press the Arrow button below REF SET to enter the value and wait for the calibration display. 11:18 Calibration manual HCEN12089 Revision 10.2012 10. Close clamp A. Apply a pressure of approx. -500 mmHg, shown on the reference instrument. Close clamp B. 11. Set the REF SET value on the AK 200 S / AK 200 ULTRA S dialysis machine display to the same value as shown on the reference instrument. 12. Press the Arrow button below REF SET to enter the value and wait for the calibration display. 13. The machine will now ask you to confirm to enter sensitivity calibration. To confirm: press the Arrow button below Yes. 14. Open clamp A and B, then close clamp A again. Apply a pressure of approx. +500 mmHg, shown on the reference instrument. Close clamp B. 15. Set the REF SET value on the AK 200 S / AK 200 ULTRA S dialysis machine display to the same value as shown on the reference instrument. 16. Press the Arrow button below REF SET to enter the value and wait for the calibration display. 17. Press the Start UF Stop button to load the value into the EEPROM. 18. Reconnect the fluid path to its original design after the calibration. 19. To exit from the Calibration routine, press the Hold button. 20. Always perform a Heat disinfection after the fluid path has been opened. Note • *If an error message is shown on the display at this point, press the Hold button and start again from step 4. If the error still exists after a second try, check that the calibration tubes are intact. If the tubes are correct, repeat the calibration procedure with a new transducer. Ex. of calibration error message: Note HCEN12089 Revision 10.2012 Calibration manual 11:19 pH-sensor calibration, FM 13 Equipment needed Bowl with pH 7 buffer solution and bowl with pH 9 buffer solution. Calibration should be performed on a regular basis to ensure optimum performance. A complete calibration procedure consists of the following steps: 1. Offset calibration, with a buffer solution (a solution with a very accurate and stable pH-value) having a pH-value in the range of pH 6.5-7.5, followed by; 2. Slope calibration, with a buffer solution having pH-value that differs at least 2 pH-units from the buffer used for offset calibration. Calibration schedule An Offset calibration should be performed after one month in operation and then every third month to verify the performance. A Complete calibration procedure should be performed at installation and then every 12 months. Offset calibration 1. Initiate drain. 2. When the Rinse/Drain button starts to flash, enter the service menu and set the AK 200 S / AK 200 ULTRA S dialysis machine display to: 3. Press the Start UF Stop button to enter calibration routine. 4. Remove the pH sensor from the pH sensor housing by loosening the nut holding the pH sensor and rinse the sensor in RO water. 5. Set REF SET on the AK 200 S / AK 200 ULTRA S dialysis machine display to pH 7. 6. Put the pH sensor in a bowl with pH 7 buffer solution which must cover the glass membrane i.e. the solution should reach at least 30 mm above the bottom of the bowl. 7. Stir in order to achieve balance in the buffer solution. Do not let the pH sensor lean against the bottom of the bowl. Wait for 2 minutes. 8. Press the Arrow button below REF SET and wait until the calibration display returns. • If an error message is shown on the display at this point, check the buffer solutions, the level in the bowl and repeat the procedure from step 1. If the error still exists after a second try, replace the pH sensor. 11:20 Calibration manual HCEN12089 Revision 10.2012 9. Press the Start UF Stop button to load the value into the EEPROM. 10. Remount the pH sensor into the pH sensor housing. Complete calibration 1. Initiate drain. 2. When the Rinse/Drain button starts to flash, enter the service menu and set the AK 200 S / AK 200 ULTRA S dialysis machine display to: 3. Press the Start UF Stop button to enter calibration routine. 4. Remove the pH sensor from the pH sensor housing by loosening the nut holding the pH sensor and rinse the sensor in RO water. 5. Set REF SET on the AK 200 S / AK 200 ULTRA S dialysis machine display to pH 7. 6. Put the pH sensor in a bowl with pH 7 buffer solution which must cover the glass membrane i.e. the solution should reach at least 30 mm above the bottom of the bowl. 7. Stir in order to achieve balance in the buffer solution. Do not let the pH sensor lean against the bottom of the bowl. Wait for 2 minutes. 8. Press the Arrow button below REF SET and wait until the calibration display returns. • If an error message is shown on the display at this point, check the buffer solutions, the level in the bowl and repeat the procedure from step 1. If the error still exists after a second try, replace the pH sensor. 9. Rinse the pH sensor in RO water. 10. Set REF SET on the AK 200 S / AK 200 ULTRA S dialysis machine display to pH 9. 11. Put the pH sensor in a bowl with pH 9 buffer solution which must cover the glass membrane i.e. the solution should reach at least 30 mm above the bottom of the bowl. 12. Stir in order to achieve balance in the buffer solution. Do not let the pH sensor lean against the bottom of the bowl. Wait for 2 minutes. 13. Press the Arrow button below REF SET and wait. The display shows: Entering sensitivity calibration 14. Press the Arrow button below Yes to confirm that the calibration continues. HCEN12089 Revision 10.2012 Calibration manual 11:21 15. When the calibration display returns, press the Start UF Stop button to load the value into the EEPROM. 16. Remount the pH sensor into the pH sensor housing. Note • The pH sensor should be changed every eighteenth month. Note 11:22 Calibration manual HCEN12089 Revision 10.2012 Blood Leakage Detector calibration, FM 24 Equipment needed Blood leakage calibration cover 1. Initiate drain. 2. Remove the blood leakage detector cover and clean the inside of the blood leakage detector housing. 3. Mount a blood leakage calibration cover (K40169001). Make sure that the filter is in horizontal position. 4. Enter the Service menu. 5. In service mode, select calibration, FM, intern and Blood Leakage Detector (FM 24). 6. Let the machine stabilize for 30 minutes. No concentrate shall be used. 7. Press the Start UF Stop button to enter the blood leakage calibration routine. 8. Set “REF SET” on the AK 200 S / AK 200 ULTRA S dialysis machine to zero. 9. Press the Arrow button below “REF SET”. * 10. Turn the calibration filter to vertical position. 11. Set “REF SET” on the Blood Monitor display to 100. 12. Press the Arrow button below “REF SET”. 13. Confirm to enter sensivity calibration by pressing the Arrow button below “YES”. * 14. Press the Start UF Stop button to store the calibration values. 15. Drain the AK 200 S / AK 200 ULTRA S dialysis machine and remount the standard blood leakage cover. *If an error message occurs during calibration: Check the position of the calibration filter and repeat from point 1. If an error occurs after a 2nd try, change the blood leakage detector. HCEN12089 Revision 10.2012 Calibration manual 11:23 Internal pressure regulator calibration (AK 200™ ULTRA S dialysis machine only) Equipment needed Pressure reference instrument, Calibration tube set. 1. Let the machine pass the functional check. 2. Press the Fluid flow button and set the main flow to 500 ml/min. 3. Activate HDF or HF. 4. Press the Pressure control button for 3 seconds until lit. 5. Connect the dialyzer coupling to the conductivity cell on the pressure reference instrument. 6. Adjust venous pressure to +100 mmHg. Check that TMP is approximately +150 mmHg. 7. Connect a tube between the substitution fluid port and the external pressure reference instrument. 8. Press the Fluid Bypass button to obtain main flow through the pressure regulator. 9. Adjust the pressure regulator to +55 mmHg ±5 mmHg. To get a correct reading, the reference instrument and the test tube must be at same height as the substitution fluid port. 10. Press the Fluid Bypass button and remove the pressure reference instrument and tube. 11:24 Calibration manual HCEN12089 Revision 10.2012 Inlet pressure regulator adjustment Equipment needed T-connector, short PEX tube, Pressure reference instrument, Calibration tube set. 1. Turn off the water supply. 2. Disconnect the inlet water tube at the test point (just before the non-return valve) according to following illustration. 3. Insert a T-connector and a short PEX tube just before the non-return valve. To prevent water from entering the disk filter/reference instrument, insert an extra volume of approx. 100 ml between the T-connector and the calibration tube set. (Use for instance a silicon tube, 100312032, with a length of 1.2 m as the extra volume). Connect the reference instrument to the calibration tube set. Important! Use a disc filter, according to the figure above, to protect the reference instrument. 4. Close clamp C. 5. Turn on the water supply. 6. Start the AK 200 S / AK 200 ULTRA S dialysis machine. Perform a functional check and wait until the conductivity and the temperature are stable. The fluid path on the OP-panel must be green before the calibration begins. 7. Zeroset the Reference instrument, wait for stable reading. 8. Close clamp A and B. Open clamp C. 9. Adjust the inlet pressure regulator until the pressure measured at the reference instrument is 900 mmHg (1.2 bar or 120 kPa). 10. Perform a Drain. 11. Turn off the water supply. Reconnect the fluid path to its original design after the calibration. 12. Always perform a Heat disinfection after the fluid path has been opened. HCEN12089 Revision 10.2012 Calibration manual 11:25 Conductivity Transducer calibration, FM 20 - with liquid concentrate Equipment needed Reference instrument The calibration is a “two point calibration”. The two points are 0 mS/cm (RO-water) and 14 mS/cm (with concentrate). Note • Before conductivity calibration, Chemical cleaning must be performed, one with Citric acid and one with Hypochlorite. • Check the temperature transducers since the temperature affects the conductivity calculations. • To keep the temperature inside the AK 200 S / AK 200 ULTRA S dialysis machine, do not remove the blood monitor and make sure the plastic shield covers the interior of the fluid monitor. • The main flow must be set to 500 ml/min. • FM 20 is the complete calibration for all conductivity transducers and is recommended by Gambro. It is possible to select between several different conductivity calibrations, to fit all needs. All these calibrations are done in the same way as described below. Refer to Service Technician's Guide / Fluid monitor flow diagram, calibration. Note 1. Start the AK 200 S / AK 200 ULTRA S dialysis machine. 2. Enter the service menu, Calibr / FM / Intern. 3. Set the display to: 4. Press the Start UF Stop button to enter calibration routine. 11:26 Calibration manual HCEN12089 Revision 10.2012 5. Place both the A and B pick-up tubes into the heating vessel. Connect the reference instrument according to the figure below. 6. Press the Fluid bypass button if lit. Let the AK 200 S / AK 200 ULTRA S dialysis machine and the reference instrument stabilise at 0 mS/cm and 37 °C for at least 30 minutes. 7. Set the REF SET value on the display to the same value as shown on the reference instrument with the Set knob. 8. Press the lit Arrow button below REF SET to enter value and wait for next display. 9. Put the A pick-up tube into the concentrate container and let the AK 200 S / AK 200 ULTRA S dialysis machine stabilize at 14 mS/cm and 37 °C for 20 minutes. 10. Set the REF SET value on the display to the same value shown on the reference instrument. 11. Press the lit Arrow button below REF SET to enter the value and wait for the calibration display. 12. The machine will now ask you to confirm to enter sensitivity calibration. To confirm: press the Arrow button below Yes. 13. Press the Start UF Stop button to load the value into the EEPROM. HCEN12089 Revision 10.2012 Calibration manual 11:27 Conductivity Transducer calibration, FM 20 - with SelectCart cartridge Equipment needed Reference instrument The calibration is a “two point calibration”. The two points are 0 mS/cm (RO-water) and 14 mS/cm (with concentrate). Note • Before conductivity calibration, Chemical cleaning must be performed, one with Citric acid and one with Hypochlorite. • Check the temperature transducers since the temperature affects the conductivity calculations. • To keep the temperature inside the AK 200 S / AK 200 ULTRA S dialysis machine, do not remove the blood monitor and make sure the plastic shield covers the interior of the fluid monitor. • The main flow must be set to 500 ml/min. • FM 20 is the complete calibration for all conductivity transducers and is recommended by Gambro. It is possible to select between several different conductivity calibrations, to fit all needs. All these calibrations are done in the same way as described below. Refer to Service Technician's Guide / Fluid monitor flow diagram, calibration. Note 1. Start the AK 200 S / AK 200 ULTRA S dialysis machine. 2. Enter the service menu, Calibr / FM / Intern. 3. Set the display to: Note • Error code FCN 5.11 001 may be issued during the calibration. This can be ignored. Note 4. Press the Start UF Stop button to enter calibration routine. 11:28 Calibration manual HCEN12089 Revision 10.2012 5. Close all latches and place both the A and B pick-up tubes in the heating vessel. 6. Connect the reference instrument according to the figure below. 7. Press the Fluid bypass button if lit. 8. Let the AK 200 S / AK 200 ULTRA S dialysis machine stabilize at 0 mS/cm and 37 °C for at least 30 minutes. 9. Set the REF SET value on the display to the same value shown on the reference instrument. 10. Press the lit Arrow button below REF SET to enter value and wait for next display. 11. Attach a SelectCart cartridge. 12. Let the AK 200 S / AK 200 ULTRA S dialysis machine stabilize at 14 mS/cm and 37 °C for 20 minutes. 13. Set the “REF. SET” value to the same value shown on the reference instrument. 14. Press the lit Arrow button below REF SET to enter the value and wait for the calibration display. 15. The machine will now ask you to confirm to enter sensitivity calibration. To confirm: press the Arrow button below Yes. 16. Press the Start UF Stop button to load the value into the EEPROM. HCEN12089 Revision 10.2012 Calibration manual 11:29 BiCart SelectⓇ - Level detector calibration Equipment needed SelectBag container (filled) General The level detector is used in the protective system for supervision of the SelectBag concentrate flow. It consists of an IR-LED and an IR-transistor placed on a fluid chamber. The goal is to form a logical output if the chamber is filled with liquid or not. The sensitivity is dependent on the modulation frequency that controls the IR-LED. This must be calibrated by adjusting the fluid level and finding the correct frequency. The calibration is performed automatically in the AK 200 S / AK 200 ULTRA S dialysis machine calibration routine and requires only a filled SelectBag container. Note • The machine should be run with fluid for approximately 30 minutes followed by a Rinse/Drain before the calibration is performed. • When the level detector is calibrated with default value (i.e. the first time), this value might cause the pump not to stop at full chamber since high level is not detected. This will mean that fluid is pumped out through the disinfection port in the SelectCart cartridge holder (lower port) during the priming phase. • To prevent that air is getting trapped inside the particle filter after the SelectBag container holder (50 μm), it is important that the particle filter is correct positioned according to following illustration. Note 11:30 Calibration manual HCEN12089 Revision 10.2012 Calibration instruction 1. Enter the AK 200 S / AK 200 ULTRA S dialysis machine service menu, Calibr / FM / Other / Lvl det. 2. Attach a SelectBag container to the SelectBag container holder. WARNING Avoid touching the plastic spike. Be careful to avoid fluid from the SelectBag container splashing into your eyes. WARNING • Open the cap on the SelectBag container. • Open and hold the latch of the SelectBag container holder in its uppermost position while hanging the SelectBag container into the holder with the connector port upwards. • Press down the latch to a horizontal position, whereby the membrane of the SelectBag container is punctured by the spike. • Tap lightly on the SelectBag container so that any air bubbles gather at the top. 3. Open both SelectCart cartridge latches and press Start. The calibration will now be performed automatically by the AK 200 S / AK 200 ULTRA S dialysis machine. Two calibrations are performed and their results are compared. If the difference are within a limit, the calibration is approved. When the calibration is ready, the following text is displayed: 4. Press the Start UF Stop button to load the value into the EEPROM. HCEN12089 Revision 10.2012 Calibration manual 11:31 Trouble shooting If the calibration was unsuccessful, the following attention is displayed: Possible reasons for problems are: • No SelectBag container inserted • Fluid tubes faulty connected/leaking • Pump volumes not calibrated • Defective level detector/misconnected • Air/foam in SelectBag fluid tubes and/or level detector chamber • Calibration values differ too much • Pumps defective or faulty connected • Defective FM CPU board If no obvious errors are found, perform a new calibration. If the calibration value storage was unsuccessful, the following attention is displayed: Possible reasons for problems are: • Defective FM CPU board • Faulty cable connections Check and replace if problems remain. 11:32 Calibration manual HCEN12089 Revision 10.2012 BiCart SelectⓇ - control and protective pump calibration Equipment needed: SelectBag container, Measuring cylinder General This calibration is intended to be done after following work operations: • Exchange of the control pump • Exchange of the protective pump • Exchange of the FM CPU board • Exchange of the select node PROM Preparations Before starting the calibration, the following preparations must be done: 1. To prevent that air is getting trapped inside the particle filter after the SelectBag container holder (50 μm), it is important that the particle filter is correct positioned according to following illustration. HCEN12089 Revision 10.2012 Calibration manual 11:33 2. Prepare the fluid path for the calibration. 2.1. Disconnect the output tube from the BiCart Select control pump at the Y-connector, according to the figure below pos. (1). 2.2. Re-connect the output tube to a silicone tube, 100312032 via connector L05172001. Put this tube into an empty fluid container. 2.3. Clamp both tubes according to the figure below pos. (2). 3. Attach a SelectBag container to the SelectBag holder. WARNING Avoid touching the plastic spike. Be careful to avoid fluid from the SelectBag container splashing into your eyes. WARNING • Open the cap on the SelectBag container. • Open and hold the latch of the SelectBag holder in its uppermost position while hanging the SelectBag container into the holder with the connector port upwards. • Press down the latch to a horizontal position, whereby the membrane of the SelectBag container is punctured by the spike. • Tap lightly on the SelectBag container so that any air bubbles gather at the top. 4. Open the lower latch of the SelectCart cartridge holder. 11:34 Calibration manual HCEN12089 Revision 10.2012 Calibration instruction 1. Enter the AK 200 S / AK 200 ULTRA S dialysis machine service menu, Calibr / FM / Other / Sel pump Following text is displayed: Priming To evacuate all air bubbles it is important to run following priming procedure before starting the calibration. 2. Press the Arrow button below Priming. Let the machine flush fluid from the SelectBag container, via the BiCart Select pumps to the empty fluid container. Tap lightly on the SelectBag container to remove any air bubbles. Continue until there are no air bubbles left after the control pump. 3. When the priming is completed (no air bubbles left), press the Arrow button below Stop. Calibration 4. Move the silicone tube from the fluid container into the Measuring cylinder. 5. Press the Arrow button below Start to enter the calibration procedure. 6. The Measuring cylinder is filled up. When the pumps stop, enter the reference volume from the Measuring cylinder in ml. Turning the Set knob sets the reference volume. The blue line on the Measuring cylinder indicates 250 ml. The Measuring cylinder is graduated in 0.2 ml increments i.e. each small mark indicates 0.2 ml. 7. To enter the reference volume press the Arrow button below REF SET and the calibration calculation starts. HCEN12089 Revision 10.2012 Calibration manual 11:35 8. When the result of the calculation is displayed, press the Start UF Stop button to load the calibration values into the EEPROM. Verification Empty the Measuring cylinder. Insert a new SelectBag container to the holder. Repeat step 6 to 10 according to the instruction above. Verify that the reference volume from the Measuring cylinder is within 250 ±2 ml. 11:36 Calibration manual HCEN12089 Revision 10.2012 Calibration of Flow Restrictor Node (FRN) main flow supervision The BiCart Select protective system uses a flow restrictor measurement for supervision of the main flow and the UF volume. The main flow is used in the supervision of the ratio between SelectBag concentrateand main flow. The Flow out restrictor and the Flow in restrictor are used to form restrictor flow measuring devices. By using the Flow Out Pressure (FOP) the main flow is calculated. By using the Flow Input Pressure (FIP) in combination with FOP the UF is calculated. Note • Before the calibration procedure is started, perform a heat disinfection. • If the machine is operated at high altitude, e.g. the preset S550 is used, the FCH must pass state 18 (SP 004) before entering Service mode. • A UF-cell calibration will automatically be followed by FRN calibration. • If following parts (in the table below) are exchanged/calibrated, a new FRN calibration must be performed and the following conditions must be fulfilled: • Stable temperature and conductivity • De air chamber level must be over 13 mm • Degassing level must be 50 mm Exchanged Calibrated FOP transducer x x FIP transducer x x FOP pump x FIP pump x pH cell x Cond. cell B x FOP restrictor x FIP restrictor x UF cell x FM CPU board x x Installed x x Note HCEN12089 Revision 10.2012 Calibration manual 11:37 Calibration instruction, with liquid concentrate 1. Enter the AK 200 S / AK 200 ULTRA S dialysis machine service menu, Calibr / FM / Other / UF 2. Press the Arrow button below Restr 3. Place the B pick-up tube in concentrate. The calibration will now be performed automatically. CALIB NR 0-6 will be displayed during calibration. RESTRICTOR UF CALIBRATION VERIFYING This attention message is displayed during verification. RESTRICTOR UF CALIBRATION VERIFICATION PASSED This attention message is displayed when verification is done and passed. The machine is ready for use. Calibration instruction, with SelectCart cartridge 1. Enter the AK 200 S / AK 200 ULTRA S dialysis machine service menu, Calibr / FM / Other / UF 2. Press the Arrow button below Restr 3. Attach a SelectCart cartridge. The calibration will now be performed automatically. CALIB NR 0-6 will be displayed during calibration. RESTRICTOR UF CALIBRATION VERIFYING This attention message is displayed during verification. RESTRICTOR UF CALIBRATION VERIFICATION PASSED This attention message is displayed when verification is done and passed. The machine is ready for use. 11:38 Calibration manual HCEN12089 Revision 10.2012 Trouble shooting A FRN calibration takes approximately 20 minutes. If the calibration is not ready within the double time, cancel and perform a new calibration. Possible reasons for problems are: • Uncalibrated UF-cell • No concentrate • Leakage in fluid path • De air chamber level <13 mm The following attention messages can be displayed for guidance. RESTRICTOR UF CALIBRATION INSUFFICIENT INLET WATER The dialysis machine is not connected to water inlet. RESTRICTOR UF CALIBRATION LOW LEVEL IN DEGASSING CHAMBER Degassing chamber is not yet filled. RESTRICTOR UF CALIBRATION LOW LEVEL IN DE AIR CHAMBER De air chamber is not yet filled, the level is below 13 mm. RESTRICTOR UF CALIBRATION SET POINT FLOW ERROR Required main flow is not achieved. RESTRICTOR UF CALIBRATION TEMPERATURE ERROR Fluid temperature is not correct. RESTRICTOR UF CALIBRATION CONDUCTIVITY ERROR Fluid conductivity is not correct. HCEN12089 Revision 10.2012 Calibration manual 11:39 RESTRICTOR UF CALIBRATION COMMUNICATION ERROR WITH FRN Communication between CPUP and FRN fails. RESTRICTOR UF CALIBRATION VERIFICATION FAILED Verification failed. The machine can not be used for treatment until a successful FRN calibration has been performed. 11:40 Calibration manual HCEN12089 Revision 10.2012 Automatic UF calibration/Supervision flow meter calibration Equipment needed UF calibration station General When automatic calibration is chosen, the Time lamp is lit. Complete automatic UF calibration calibrates the UF cell and the supervision flow meter. The UF calibration unit is used as reference in the calibration. (Refer to the UF calibration unit - User Guide, HCEN9786.) Note that the verification of the UF cell calibration has to be done manually, refer to page 11:44. Prior to the calibration perform both a disinfection and a cleaning decalcification to remove both organic and calcium precipitates, according to the AK 200 S / AK 200 ULTRA S Operator’s Manual. Prior to the calibration perform: 1. A decalcification to remove calcium precipitates. 2. A disinfection to remove organic residuals. For details, refer to the AK 200 S / AK 200 ULTRA S Operator’s Manual. HCEN12089 Revision 10.2012 Calibration manual 11:41 Running the UF calibration, with liquid concentrate 1. AK 200 ULTRA S dialysis machine only: Bypass the internal pressure regulator when running the UF calibration. Note • All electrical connections must be done before the power is turned on to the UF calibration box and the AK 200 S / AK 200 ULTRA S dialysis machine. Be aware of that there is no main switch on the UF calibration box. • Switch on the equipment in the following order: 1. Connect the UF calibration box to the mains. 2 . Switch on the AK 200 S / AK 200 ULTRA S dialysis machine with the main switch and then the ON/OFF button. Note 2. Use the UF calibration cable, to connect the UF calibration box, with the AK 200 S / AK 200 ULTRA S dialysis machine. 3. Connect the cable to the external connection port P 76 (blue coloured) at the rear of the AK 200 S / AK 200 ULTRA S dialysis machine. 4. Put the B suction tube to A concentrate container (or acetate container), A suction tube in the heating vessel. 5. Enter service mode. 6. Connect the fluid tubes to the UF calibration box. 7. Select Service mode and then Calibr / FM / Other / UF / Auto / Complete and set the reference volume. After the reference volume is confirmed the UF calibration runs automatically until the calibration is finished. Nothing happens if the operator by mistake should press the high limit key during automatic calibration. Note • Do not change to manual calibration while the box is filling or emptying! Note When the automatic UF calibration/Supervision flow meter calibration is finished, a verification has to be done. 11:42 Calibration manual HCEN12089 Revision 10.2012 Running the UF calibration, with SelectCart cartridge 1. AK 200 ULTRA S dialysis machine only: Bypass the internal pressure regulator when running the UF calibration. Note • All electrical connections must be done before the power is turned on to the UF calibration box and the AK 200 S / AK 200 ULTRA S dialysis machine. Be aware of that there is no main switch on the UF calibration box. • Switch on the equipment in the following order: 1. Connect the UF calibration box to the mains. 2 . Switch on the AK 200 S / AK 200 ULTRA S dialysis machine with the main switch and then the ON/OFF button. Note 2. Use the UF calibration cable, to connect the UF calibration box, with the AK 200 S / AK 200 ULTRA S dialysis machine. 3. Connect the cable to the external connection port P 76 (blue coloured) at the rear of the AK 200 S / AK 200 ULTRA S dialysis machine. 4. Attach a SelectCart cartridge. 5. Enter service mode. 6. Connect the fluid tubes to the UF calibration box. 7. Select Service mode and then Calibr / FM / Other / UF / Auto / Complete and set the reference volume. After the reference volume is confirmed the UF calibration runs automatically until the calibration is finished. Nothing happens if the operator by mistake should press the high limit key during automatic calibration. Note • Do not change to manual calibration while the box is filling or emptying! Note When the automatic UF calibration/Supervision flow meter calibration is finished, a verification has to be done. HCEN12089 Revision 10.2012 Calibration manual 11:43 Verification of the UF cell calibration Must be performed after automatic UF calibration/Supervision flow meter calibration is performed. 1. Restart the AK 200 S / AK 200 ULTRA S dialysis machine and let it pass Fch. 2. Press the Fluid Flow button and set the main flow rate to 400 ml/min. 3. Measure the drain flow during two minutes, use a graduated vessel with a volume of approximately 1.5 l. Tap the drain flow during exactly two minutes, the measured volume should be 800 ml ±16 ml. For accurate test, keep the hose at the same height during the entire test. 4. Set the Main flow to 600 ml/min and measure the drain flow as described above. The measured volume should be 1200 ml ±24 ml. 5. Rinse the AK 200 S / AK 200 ULTRA S dialysis machine after the verification. Note • Switch off the equipment in the following order: 1. Switch off the AK 200 S / AK 200 ULTRA S dialysis machine with the ON/OFF button and then the main switch. 2. Disconnect the UF calibration station (mains cable). Note 11:44 Calibration manual HCEN12089 Revision 10.2012 Calibration, Blood Monitor A/D Converter BM (CPU P), BM 4 Equipment needed Digital voltmeter 1. Start the AK 200 S / AK 200 ULTRA S dialysis machine and enter the service menu, Calibr / BM. 2. Set the display to: 3. Press the Start UF Stop button to enter calibration routine. 4. Measure the voltage between TP 4 (earth) and TP 5 (ref) on the BM CPU board. (See figure below) 5. Set the REF SET on the display to the value shown on the voltmeter (min. 48.96 mV max. 50.88 mV). Press the Arrow button to confirm. 6. Press the Start UF Stop button to load the value into the EEPROM. HCEN12089 Revision 10.2012 Calibration manual 11:45 Venous Pressure Transducer calibration, BM 3 Equipment needed Pressure reference instrument, Calibration tube set. Tolerance -700 to -500 mmHg ±10% -500 to +500 mmHg ±5 mmHg or ±3% +500 to +750 mmHg ±10% 1. Start the AK 200 S / AK 200 ULTRA S dialysis machine and enter the service menu, Calibr / BM. 2. Set the display to: 3. Press the Start UF Stop button to enter calibration routine. 4. Connect Gambro reference instrument to the Venous Pressure Transducer according to the figure. 5. Apply zero pressure by opening the three clamps A, B and C on the calibration tube set. 6. Set the REF SET value on the display to 0 mmHg (with the Set knob). 7. Press the Arrow button below REF SET to enter the value and wait for the calibration display. 8. Close clamp A. Apply a pressure of approx. -500 mmHg, shown on the reference instrument. Close clamp B. 9. Set the REF SET value on the AK 200 S / AK 200 ULTRA S dialysis machine display to the same value as shown on the reference instrument. 10. Press the Arrow button below REF SET to enter the value and wait for the calibration display. 11. The machine will now ask you to confirm to enter sensitivity calibration. To confirm: press the Arrow button below Yes. 12. Open clamp A and B, then close clamp A again. Apply a pressure of approx. +500 mmHg, shown on the reference instrument. Close clamp B. 13. Set the REF SET value on the AK 200 S / AK 200 ULTRA S dialysis machine display to the same value as shown on the reference instrument. 14. Press the Arrow button below REF SET to enter the value and wait for the calibration display. 11:46 Calibration manual HCEN12089 Revision 10.2012 15. Press the Start UF Stop button to load the value into the EEPROM. 16. To exit from the Calibration routine, press the Hold button. HCEN12089 Revision 10.2012 Calibration manual 11:47 Arterial Pressure Transducer calibration, BM 2 Equipment needed Pressure reference instrument, Calibration tube set. Tolerance -700 to -500 mmHg ±10% -500 to +500 mmHg ±5 mmHg or ±3% +500 to +750 mmHg ±10% 1. Start the AK 200 S / AK 200 ULTRA S dialysis machine and enter the service menu, Calibr / BM. 2. Set the display to: 3. Press the Start UF Stop button to enter calibration routine. 4. Connect Gambro reference instrument to the Arterial Pressure Transducer according to the figure. 5. Apply zero pressure by opening the three clamps A, B and C on the calibration tube set. 6. Set the REF SET value on the display to 0 mmHg (with the Set knob). 7. Press the Arrow button below REF SET to enter the value and wait for the calibration display. 8. Close clamp A. Apply a pressure of approx. -500 mmHg, shown on the reference instrument. Close clamp B. 9. Set the REF SET value on the AK 200 S / AK 200 ULTRA S dialysis machine display to the same value as shown on the reference instrument. 10. Press the Arrow button below REF SET to enter the value and wait for the calibration display. 11. The machine will now ask you to confirm to enter sensitivity calibration. To confirm: press the Arrow button below Yes. 12. Open clamp A and B, then close clamp A again. Apply a pressure of approx. +500 mmHg, shown on the reference instrument. Close clamp B. 13. Set the REF SET value on the AK 200 S / AK 200 ULTRA S dialysis machine display to the same value as shown on the reference instrument. 14. Press the Arrow button below REF SET to enter the value and wait for the calibration display. 11:48 Calibration manual HCEN12089 Revision 10.2012 15. Press the Start UF Stop button to load the value into the EEPROM. 16. To exit from the Calibration routine, press the Hold button. HCEN12089 Revision 10.2012 Calibration manual 11:49 System Pressure Transducer calibration, BM 1 Equipment needed Pressure reference instrument, Calibration tube set. Tolerance -700 to -500 mmHg ±10% -500 to +500 mmHg ±5 mmHg or ±3% +500 to +750 mmHg ±10% 1. Start the AK 200 S / AK 200 ULTRA S dialysis machine and enter the service menu, Calibr / BM. 2. Set the display to: 3. Press the Start UF Stop button to enter calibration routine. 4. Connect Gambro reference instrument to the System Pressure Transducer according to the figure. 5. Apply zero pressure by opening the three clamps A, B and C on the calibration tube set. 6. Set the REF SET value on the display to 0 mmHg (with the Set knob). 7. Press the Arrow button below REF SET to enter the value and wait for the calibration display. 8. Close clamp A. Apply a pressure of approx. -500 mmHg, shown on the reference instrument. Close clamp B. 9. Set the REF SET value on the AK 200 S / AK 200 ULTRA S dialysis machine display to the same value as shown on the reference instrument. 10. Press the Arrow button below REF SET to enter the value and wait for the calibration display. 11. The machine will now ask you to confirm to enter sensitivity calibration. To confirm: press the Arrow button below Yes. 12. Open clamp A and B, then close clamp A again. Apply a pressure of approx. +500 mmHg, shown on the reference instrument. Close clamp B. 13. Set the REF SET value on the AK 200 S / AK 200 ULTRA S dialysis machine display to the same value as shown on the reference instrument. 14. Press the Arrow button below REF SET to enter the value and wait for the calibration display. 11:50 Calibration manual HCEN12089 Revision 10.2012 15. Press the Start UF Stop button to load the value into the EEPROM. 16. To exit from the Calibration routine, press the Hold button. HCEN12089 Revision 10.2012 Calibration manual 11:51 Level Detector calibration (Air detector), BM 5 Equipment needed Drip chamber, Pressure meter, Calibration tube set. 1. Start the AK 200 S / AK 200 ULTRA S dialysis machine and enter the service menu, Calibr / BM. 2. Set the display to: 3. Press the Start UF Stop button to enter calibration routine. 4. Insert a filled drip chamber. It is recommended that both the water and the drip chamber have a temperature of 37 °C. Make sure that the level detector (Air detector) and drip chamber are dry and clean. The drip chamber shall be from the same type of blood line as used during treatment. 5. Apply a pressure of 100 mmHg (± 10 mmHg), to the venous drip chamber. Use the pressure meter as reference. Note • When creating a positive pressure in the venous drip chamber, a more treatment like condition is simulated as the pressure inside the drip chamber becomes approximately the same as the venous pressure during treatment. The purpose is to get a better contact between the chamber and the air detector head, which results in a higher calibration value. Note 6. Wait for 2 minutes and then press the lit Arrow button 7. The calibration is now performed automatically and the calibration factor is written into the EEPROM. 8. The calibration result is displayed: The value under LEVEL is the new alarm limit, which shall be 50 or higher. The value under TRANSMIT is the transmission level, which is normally 255 but can also be 160, if the air detector is exceptionally good. 11:52 Calibration manual HCEN12089 Revision 10.2012 Trouble shooting If the calibration value has not stabilized within 5 minutes, the following error message is displayed: The reason for the error is probably that the drip chamber was moved during the calibration. Make sure that the drip chamber is correctly inserted, that there is no air bubbles in the water and that the temperature is 37 °C. If the alarm limit is too high or too low, the following error message is displayed: If the problem remains, the air detector is malfunctioning and must be replaced. If the verification of the calibration fails, the following error message is displayed: The reason for the error is probably that the drip chamber was moved during the calibration. If the problem remains, some circuit is broken on the BM CPU board. HCEN12089 Revision 10.2012 Calibration manual 11:53 Priming Detector calibration, BM 6 Equipment needed Reference tube 1. Start the AK 200 S / AK 200 ULTRA S dialysis machine and enter the service menu, Calibr / BM. 2. Set the display to: 3. Press the Start UF Stop button to enter calibration routine. 4. The display shows: 5. Insert an empty reference tube in the priming detector. The reference tube shall be from the same type of blood line as used during treatment. 6. Press the lit Arrow button 7. The calibration is now performed automatically and the calibration factor is written into the EEPROM. 8. The calibration result is displayed: 9. Press the lit Arrow button to confirm. 11:54 Calibration manual HCEN12089 Revision 10.2012 Blood Volume Sensor - BVS Calibration of the BVS unit can’t be done in the field. If necessary, replace the complete BVS unit. Refer to chapter Replacements for information regarding exchange of the BVS unit. The functionality of the BVS unit can be tested during simulated treatment according to AK 200 S / AK 200 ULTRA S Maintenance manual. Temperature BM CPU Board calibration, BM 0 Equipment needed Temperature meter 1. Place the Blood Monitor in service position. 2. Make sure AK 200 S / AK 200 ULTRA S dialysis machine has been switched off for at least 30 min. without being moved (to assure room temperature on the BM CPU board). Also make sure the reference instrument transducer has been in room temperature at least 30 minutes. 3. Start the AK 200 S / AK 200 ULTRA S dialysis machine and enter the service menu, Calibr / BM. 4. Set the display to: 5. Press the Start UF Stop button to enter calibration routine. 6. Read the room temperature on a Temperature meter and set the REF SET value on the AK 200 S / AK 200 ULTRA S dialysis machine display to the same value. 7. Press the lit Arrow button below REF SET to enter the value and wait for the calibration display. 8. Press the Start UF Stop button to load the value into the EEPROM. HCEN12089 Revision 10.2012 Calibration manual 11:55 Occlusion adjustment, blood pump/substitution flow pump • Check surface on the roller at the pump rotor, if it is damaged exchange the unit. • The roller unit should easily go back to upper end position when it has been pressed down to end position. Exchange unit if it gets stuck in any position. Note • If the pump segment has a different wall thickness, the occlusion of the pump must be adjusted to the correct wall thickness. Note Use the gauge pins (stop/go) available in the kit K40158001. The kit includes following three different gauge pins: T = 1.1 (Stop pin = 1.1x2x0.7 = 1.5mm) T = 1.6 (Stop pin = 1.6x2x0.7 = 2.2mm) T = 2.0 (Stop pin = 2.0x2x0.7 = 2.8mm) T = wall thickness of the tubing Use following formula to calculate which gauge pin to use: 2 x wall thickness x 0,7 (mm) Adjustment instruction Check the range between the pump rollers and the path according to the picture below. Adjust range between the pump rollers and the path if it is necessary. • The GO pin should barely pass within the calibrating area. • The STOP pin is NOT allowed to pass in any point within the calibrating area. Note Put grease on the GO and STOP pins when not used and store the pins in a plastic bag to prevent it from corroding. Note 11:56 Calibration manual HCEN12089 Revision 10.2012 BPM test Equipment needed BPM test equipment, Pressure reference instrument, Calibration tube kit. The functionality of the blood pressure module, BPM, is described in chapter Technical Description. The maintenance to be carried out for the module is to check the accuracy of the pressure transducers, to check the air leakage and to check the inflation speed. By entering the service menu it is possible to perform a check of the BPM device to determine if it works correctly. It is recommended to perform the test at least every 12 months or after a repair/exchange of the BPM. Test method 1. Attach BPM cuff, 110350, tight to the BPM test equipment, K22151001. 2. Start the AK 200 S / AK 200 ULTRA S dialysis machine with the main switch and the ON/OFF button. 3. Enter Service mode, Diagnose / BM / Others and BPM HCEN12089 Revision 10.2012 Calibration manual 11:57 BPM sub-tests Following sub-tests are included: • Air leakage test: measures that the equipment is airtight. • Inflation speed test: measures the time to fill the cuff with air. • Static pressure: Check of pressure transducer calibration Each of the tests can be carried out separately but the above order for carrying out the sub-tests is recommended. Check that the results from the sub-tests not exceed following limits: 11:58 • Air leakage: maximum 18 mmHg/ 3 min • Inflation speed: 2 -11 s • Static pressure: Maximum deviation from reference to be within ± 3 mm Hg. 20 ± 3 mmHg 150 ± 3 mmHg 260 ± 3 mmHg Calibration manual HCEN12089 Revision 10.2012 Check of air leakage By entering this test mode the air leakage for the BPM module, cuff hose and cuff will be tested automatically. Before entering the test mode cuff and cuff hose to be connected to the AK 200 S / AK 200 ULTRA S dialysis machine. Cuff to be wrapped tight to the BPM test equipment. BPM test equipment is used to simulate the patient arm circumference. The air leakage is only tested for 90 sec but the value is recalculated for 3 minutes. If the displayed value is above 18 mm Hg / 3 minutes, this indicates that there is a possible air leakage in the system. It is of course also possible to perform this test without the cuff and cuff hose connected but then the test will only check for air leakage within the AK 200 S / AK 200 ULTRA S dialysis machine. In this case replace the cuff and cuff hose by a tube, which is closed. Check of inflation speed By entering this test mode the capacity of the pump within the module will be tested automatically. Before entering the test mode cuff and cuff hose to be connected to the AK 200 S / AK 200 ULTRA S dialysis machine. Cuff to be wrapped tight to the BPM test equipment. If the displayed time is above 11 seconds, this test indicates that the pump is worn-out. Check of pressure transducer calibration and measured pressure By entering this test mode it will be possible to check the actual pressure value of the BPM pressure on the AK 200 S / AK 200 ULTRA S dialysis machine display. Before entering the test mode, pressure transducer calibration tube from kit K13983002 to be connected to the BPM connector on the AK 200 S / AK 200 ULTRA S dialysis machine. No cuff and cuff hose to be connected. Note • The pressure transducer calibration tube kit must be drained before being connected, to make sure that no fluids or particles enters the BPM connector or tubing’s. This might otherwise damage or destroy the sensitive BPM sensors. Note When “Current pressure: xxx mmHg” is displayed it is possible to start applying the external reference pressure. Note • The BPM is equipped with an over pressure protection. It is activated for pressures above 300 mmHg. • The pressure transducer test is to be performed within approx. 2 minutes. Then the pressure is automatically released. Note HCEN12089 Revision 10.2012 Calibration manual 11:59 To check the actual pressure value, external pressure reference instrument to be connected and external pressure of 250, 150, 50 mmHg to be applied. Check deviation from reference pressure instrument for displayed value. 11:60 Calibration manual HCEN12089 Revision 10.2012 Logging after calibration When calibration has been performed, it is recommended to log the values shown in the table on page 11:61. To run GXL-logging, the following facilities must be available and connected as shown in fig: Procedure 1. Start the AK 200 S / AK 200 ULTRA S dialysis machine. 2. Press Volume Control button. 3. Set temperature value: 37.0 °C. 4. Set main flow to: 500 ml/min. 5. Select suitable mode: BiCart, Acetate or Liquid Bicarbonate. 6. Let the AK 200 S / AK 200 ULTRA S dialysis machine run for at least 30 minutes, bypass off. 7. Start the GXL-program on the PC. Logging values Note • The table on next page is valid for a main flow of 500 ml/min, and values are to be used as guidance. Local deviations may occur due to differences in e.g. incoming water temperature, operating altitude or ambient temperature. • Conductivity values correspond to the preset concentrate and set values. Note HCEN12089 Revision 10.2012 Calibration manual 11:61 Array Unit BiCart Acetate Liquid Bicarbonate SRI 89 Heat rods duty cycle % < 30.00 < 30.00 < 30.00 SRI 14 Temperature vessel °C 37.50 ±0.50 37.50 ±0.50 37.80 ±0.50 SRI 15 Temperature cell A control °C 37.20 ±0.50 37.40 ±0.50 37.40 ±0.50 SRI 116 Temperature cell A PRS °C 37.20 ±0.50 37.40 ±0.50 37.40 ±0.50 SRI 16 Temperature cell B PRS °C 37.00 ±0.50 37.00 ±0.50 37.00 ±0.50 SRI 115 Temperature cell B control °C 37.00 ±0.50 37.00 ±0.50 37.00 ±0.50 SRI 13 Conductivity cell A control mS/cm 12.301 ±0.502 0 ±0.502 9.505 ±0.502 SRI 114 Conductivity cell A PRS mS/cm 12.301 ±0.502 0 ±0.502 9.505 ±0.502 SRI 12 Conductivity cell B control mS/cm 14.301 ±0.502 14.001 ±0.502 14.301 ±0.502 SRI 11 Conductivity cell B PRS mS/cm 14.301 ±0.502 14.001 ±0.502 14.301 ±0.502 SRI 8 Degassing pressure mmHg -580.01 ±20.0 -630.01 ±20.0 -580.01 ±20.0 SRI 10 Flow out pressure mmHg -175.0 ±40.0 -175.0 ±40.0 -175.0 ±40.0 SRI 6 HPG pressure mmHg -954 ±25.0 -954 ±25.0 -954 ±25.0 SRI 7 SAG pressure mmHg -120 ±50.0 -120 ±50.0 -120 ±50.0 SRI 4 PD pressure mmHg -125 ±15.0 -125 ±15.0 -125 ±15.0 SRI 9 Flow in pressure mmHg +175 ±50.0 +175 ±50.0 +175 ±50.0 SRI 71 A-pump deviation % < ±5.0 - < ±5.0 SRI 72 B-pump deviation % < ±5.0 - < ±5.0 SRI 73 Ac-pump deviation % - < ±5.0 - SRI 97 Degassing pump duty cycle % < 75.0 < 70.0 < 70.0 SRI 31 Flow out pump duty cycle % < 50.0 < 50.0 < 50.0 SRI 35 Flow in pump duty cycle % < 50.0 < 50.0 < 50.0 SRI 0 System pressure mmHg 0.0 ±5.0 0.0 ±5.0 0.0 ±50 SRI 1 Venous pressure mmHg 0.0 ±5.0 0.0 ±5.0 0.0 ±5.0 SRI 82 Arterial pressure mmHg 0.0 ±5.0 0.0 ±5.0 0.0 ±5.0 SRI 24 Blood leakage detector value5 - 0 ±10 0 ±10 0 ±10 SRI 25 Flow rate channel 1 ml/min 500 ±1 500 ±1 500 ±1 SRI 26 Flow rate channel 2 ml/min 500 ±3 500 ±3 500 ±3 SRB 0 Level det. transmit level 255 or 160 - - - SRB 89 Level det. comparation level min. 50 max 98 - - - SRB 2 Priming detector blood level 15 - 236 - - - 1 Can be preset Maximum difference between conductivity cell A & B = 0.3 mS/cm. Maximum difference within a cell is 0.2 mS/cm 3 Default liquid concentrate 4 Depending on pressure drop in ultrafilter (ULTRA or UFD) 5 Machine in blood mode and no pressure at safety guard during 1 minute. 2 11:62 Calibration manual HCEN12089 Revision 10.2012 Chapter 12 FM flow diagrams HCEN12089 Revision 10.2012 12:1 &LOW PATH &LOW RESTRICTOR 2ECIRCULATION VALVE 2&6! &,6! ).6! .ON RETURN VALVE /VER FLOW &ILTER &ILTER &LOW RESTRICTOR 0!6! -IXING CHAMBER $26! # 4 4 .ON RETURN VALVE ,$6! 0 - $EGASSING RESTRICTOR 0 #OND 4 CELL ! # 0"6! &LOW OUTPUT PUMP &EEDING PUMP " "#6! "I#ART 4 4 &/6! &EEDING PUMP ! 406! &ILTER &LOW OUTPUT PRESSURE 0 "LOOD LEAK DETECTOR "UBBLE TRAP %66! &LOW INPUT PUMP 0ARTICLE FILTER 0 0$ 5& MEASURING CELL %-6! 4 2ESTRICTOR 2ESTRICTOR :%6! "I#ART &LOW INPUT PRESSURE 0 0URE WATER INLET 0 #OND CELL " &ILTER &ILTER P( SENSOR 0 $EGASSING PUMP 0ROTECTIVE PUMP 3ELECT "AG 0RESSURE REGULATOR $EGASSING CHAMBER WITH LEVEL DETECTOR $EGASSING PRESSURE #ONTROL PUMP ,EVEL DETECTOR 3ELECT (EAT %X CHANGER (EATING VESSEL %XPANSION CHAMBER $EAIRATING CHAMBER WITH LEVEL DETECTOR #OND CELL # 4!6! 0 3!' $RAIN 0URE WATER 3ELECT"AG CONCENTRATE 3ELECT#ART CONCENTRATE ! CONCENTRATE " CONCENTRATE $IALYSIS FLUID $IALYSATE 0 (0' 3AFETY BY PASS UNIT "96! $)6! (#%. ¥ 'AMBRO ,UNDIA !" 2EV 0210 !+ 3 AK 200 S UFD Flow path FLVA Heat Exchanger Heating vessel Filter Flow restrictor PAVA Mixing chamber DRVA C T T P M Degassing restrictor P Cond T cell A C PBVA Feeding pump A Flow output pump Feeding pump B BCVA BiCart T T FOVA Filter TPVA Filter Flow output pressure P Blood leak detector Bubble trap EVVA Flow input pump Particle filter P PD UF-measuring cell EMVA T Restrictor Restrictor ZEVA BiCart Flow input pressure P Pure water inlet P Cond cell B Protective pump Select Bag Filter pH-sensor P Degassing pump Control pump Level detector Pressure regulator Degassing chamber with level detector Degassing pressure LDVA Select Nonreturn valve Over flow Filter Nonreturn valve INVA Expansion chamber Recirculation valve RFVA Deairating chamber with level detector Cond cell C 2 1 TAVA P SAG Drain Pure water SelectBag concentrate SelectCart concentrate A concentrate B concentrate Dialysis fluid Dialysate P Safety by-pass unit FIVA HPG Dialysis fluid filter U8000S BYVA DIVA HCEN10398 10395 © 2006.05. Gambro Lundia AB. Rev. 02.2010 Flow restrictor !+ 5,42! 3 3 7ATER FILTER 53 &LOW RESTR ICTOR &,6! (EAT %X CHANGER .ON RETURN VALVE /VER FLOW &ILTER &LOW RESTRICTOR 0!6! -IXING CHAMBER $26! # 4 4 .ON RETURN VALVE ,$6! - 0 $EGASSING RESTRICTOR 0 #OND 4 CELL ! # 0"6! &LOW OUTPUT PUMP &EEDING PUMP " "#6! "I#ART 4 4 &/6! &EEDING PUMP ! 406! &ILTER &LOW OUTPUT PRESSURE 0 "LOOD LEAK DETECTOR "UBBLE TRAP %66! &LOW INPUT PUMP 0ARTICLE FILTER 0 0$ 5& MEASURING CELL %-6! 4 2ESTRICTOR 2ESTRICTOR :%6! "I#ART &LOW INPUT PRESSURE 0 0URE WATER INLET 0 #OND CELL " &ILTER &ILTER P( SENSOR 0 $EGASSING PUMP 0ROTECTIVE PUMP 3ELECT "AG 0RESSURE REGULATOR $EGASSING CHAMBER WITH LEVEL DETECTOR $EGASSING PRESSURE #ONTROL PUMP ,EVEL DETECTOR 3ELECT ).6! (EATING VESSEL &ILTER .ON RETURN VALVE %XPANSION CHAMBER 2ECIRCULATION VALVE 2&6! $EAIRATING CHAMBER WITH LEVEL DETECTOR #OND CELL # 4!6! 0 3!' $RAIN 0URE WATER 3ELECT"AG CONCENTRATE 3ELECT#ART CONCENTRATE ! CONCENTRATE " CONCENTRATE $IALYSIS FLUID $IALYSATE 0 3AFETY BY PASS UNIT #76! ($6! 0RESSURE REGULATOR &)6! (0' $IALYSIS FLUID FILTER Substitution fluid PORT 53 "96! $)6! (#%. ¥ 'AMBRO ,UNDIA !" 2EV 210 &LOW RESTRICTOR &LOW PATH A Air detector . . . . . . . . . . . . . . . . 6:38 B Batteries . . . . . . . . . . . Battery back-up technical data . . . . . . BCVA - BiCart Valve . . Blood Pressure Monitor Blood Pump Unit . . . . . Blood Volume Sensor . . BPM . . . . . . . . . . . . . . technical data . . . . . . BVS . . . . . . . . . . . . . . technical data . . . . . . BYVA - Bypass Valve . . . . . . . . 6:38 . . . . . . . . . . . . 7:14, 8:14 . . . . . . 6:25 . . . . . . 6:40 . . . . . . 6:38 . . . . . . 6:38 . . . . . . 6:40 . . . . 7:4, 8:4 . . . . . . 6:38 . . . . 7:3, 8:3 . . . . . . 6:25 C CWVA - Clean Water Valve 6:13, 6:25 D Dialysis fluid preparation, technical data . . . .7:5, 7:16, 8:5, 8:16 DiascanⓇ technical data . . . . . . . . . . . 7:7, 8:7 Distribution Board BM Analog Distribution Board 6:42 DIVA - Direct Valve . . . . . . . . . 6:25 Drip Chamber Level Adjustment . . . . . . . . . . 6:39 DRVA - Degass Resctriction Valve . . . . . . . . . . . . . . . . . . . 6:25 H HDVA - HD/HDF Valve . . . . . . . 6:25 Heparin Heparin Pump Unit . . . . . . . . 6:39 Heparin Pump Unit . . . . . . . . . . 6:39 I Infusion infusion pole . . . . . height adjustment Inlet water quality . . . . . . . . . . INVA - Inlet Valve . . . . . . . . . . . 6:49 . . . . . . . . 6:49 . 2:7, 7:11, 8:11 . . . . . . . . 6:25 L LDVA - Level Detector Valve . . . 6:26 Level Detector . . . . . . . . . . . . . . 6:38 Line Clamp Unit . . . . . . . . . . . . 6:39 E M Electromagnetic environment . . .7:21, 8:21 EMVA - Emptying Valve . . . . . . 6:25 EVVA - Evacuation Valve . . . . . 6:25 Machine physical data . . . . . . 2:5, 7:18, 8:18 power supply . . . . . . 2:6, 7:12, 8:12 transportation and storage . . . .7:20, 8:20 Monitor stand bars, lifting positions . . . . . . . 6:49 rear handle . . . . . . . . . . . . . . . 6:49 screws . . . . . . . . . . . . . . . . . . 6:49 F Fan . . . . . . . . . . . . FIVA - Filter Valve FLVA - Flush Valve FM valves BCVA . . . . . . . . BYVA . . . . . . . . CWVA . . . . . . . DIVA . . . . . . . . DRVA . . . . . . . . EMVA . . . . . . . . EVVA . . . . . . . . FIVA . . . . . . . . . FLVA . . . . . . . . FOVA . . . . . . . . HCEN12089 Revision 10.2012 HDVA . . . . . . . . . . . . . . . . . . 6:25 INVA . . . . . . . . . . . . . . . . . . 6:25 LDVA . . . . . . . . . . . . . . . . . . 6:26 PAVA . . . . . . . . . . . . . . . . . . 6:26 PBVA . . . . . . . . . . . . . . . . . . 6:26 Recirculation Valve . . . . . . . . 6:26 RFVA . . . . . . . . . . . . . . . . . . 6:26 TAVA . . . . . . . . . . . . . . 6:13, 6:26 TPVA . . . . . . . . . . . . . . . . . . 6:26 ZEVA . . . . . . . . . . . . . . 6:13, 6:26 FOVA - Flow Output bypass Valve . . . . . . . . . . . . . . . . . . . 6:25 Functional check overview screen . . . . . . . . . . . 5:12 . . . . . . . . . . 6:39 . . . . . . 6:13, 6:25 . . . . . . . . . . 6:25 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:25 . . . . . 6:25 . 6:13, 6:25 . . . . . 6:25 . . . . . 6:25 . . . . . 6:25 . . . . . 6:25 . 6:13, 6:25 . . . . . 6:25 . . . . . 6:25 O Operator's Panel . . . . . . . . . . . . 6:39 P PAVA - Priming A Valve . . . . . PBVA- Proportion Bypass Valve Physical data of the machine . . . 7:18, 8:18 Pressure Transducers . . . . . . . . Arterial Pressure Transducer . . 6:26 . 6:26 . .2:5, . 6:40 . 6:40 System Pressure Transducer Venous Pressure Transducer Priming Detector . . . . . . . . . Profiling technical data . . . . . . . . . . . . 6:40 . . 6:40 . . . 6:40 . 7:6, 8:7 T TAVA- Taration Valve . . . . 6:13, 6:26 TPVA- Top Priming Valve . . . . . 6:26 Tray for concentrate containers . . 6:49 Treatment overview screen . . . . . 5:10 R U Recirculation Valve . . . . . . . . . . 6:26 RFVA- Return Flush Valve . . . . . 6:26 Ultrafiltration control, technical data . . . . . 7:6, 8:6 technical data . . . . . . . . . 7:17, 8:17 S Single Needle Treatment . . . . Double Pump Single Pump Standards . . . . . . Substitution fluid technical data . . . . . . W . . . . . . . . . . . . . . . . . . . . . . . . . 6:34 . . . . . 6:35 . . . . . 6:34 . 7:25, 8:25 Wheels, lockable . . . . . . . . . . . . 6:49 Z ZEVA- Zeroing Valve . . . . 6:13, 6:26 . . . . . . . . . . . . 8:6 HCEN12089 Revision 10.2012
