gambro ak 200 s - service manual
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AK 200 S - Operators manual
Program version 8.xx
1. Before you get started - general information
2. Description - the machine and its components
3. Controll ing the machine - general guidelines
4. Hemodialysis, double needle treatment
5. Hemodialysis, single needle treatment
6. Isolated UF
7. Profiling
8. Hemodiafi ltration, low volume
9. BVS - Blood Volume Sensor
10. BPM - Blood Pressure Monitor option
11. Diascan
12. Hygiene and maintenance
13. Technical data and specifications
14. Alarm list, Attention alarm list and Technical alarm list
15. Major changes in operators manual
16. Index
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Contents
1. Before you get started - general information
How to use this manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:2Definitions of expressions used in this manual . . . . . . . . . . . . . . . . . . 1:4
General precautions before use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:5Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:8Safety philosophy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:9
The preparation of dialysis fluid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:12Inlet water requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:12Preparation of the dialysis fluid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:12UFD- Ultrafiltered Dialysis Fluid (option) . . . . . . . . . . . . . . . . . . . . . . 1:12Ultrafilters; frequency of change . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:12
List of concentrates, accessories and disposables, for use with theAK 200 S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:13
Concentrates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:13
Lines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:14Dialyzers/Ultrafilter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:14Infusion fluid for low volume HDF . . . . . . . . . . . . . . . . . . . . . . . . 1:15Blood pressure measurement accessories . . . . . . . . . . . . . . . . . . . . 1:15
List of symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:16CE-marking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:18
Manufacturer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:18Copyright . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:18
2. Description - the machine and its components
Blood monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2:2BM 200 - Single Pump, BM 202 - Double Pump . . . . . . . . . . . . . . . . . 2:2
Fluid monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2:4FM 202 - Acetate and Bicarbonate . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2:4
Rear of the machine - without options . . . . . . . . . . . . . . . . . . . . . . . . . . . 2:6Rear of the machine - options included . . . . . . . . . . . . . . . . . . . . . . . . . . . 2:8Monitor stand . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2:10
MS 200: Adjustable height: five fixed positions . . . . . . . . . . . . . . . . . . 2:10MS 202: Electrically adjustable height . . . . . . . . . . . . . . . . . . . . . . . . . 2:12
3. Controlling the machine - general guidelinesOperators panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:2Hygiene group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:4Mode group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:5
Concentrate stand-by mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:6Procedure for manual activation . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:7Resume fluid preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:7
Therapy group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:9Treatment overview group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:10
Bargraph display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:10Flow diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:10
Time display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:11Parameter buttons and their displays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:12
Reset possibilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:16Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:17
Alarm indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:17
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Alarm function of the parameter buttons . . . . . . . . . . . . . . . . . . . . . . . 3:18Override possibilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:20Stand-by group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:22Display and setting group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:23
Information display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:23
Treatment overview screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:24Parameters shown on Treatment overview screen . . . . . . . . . . . . . . . . 3:25Function check overview screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:26
Tests shown on Function check overview screen . . . . . . . . . . . . . . . . . 3:27The eight commandments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:28Setting of parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:29Downloading treatment parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:32
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:33The ultrafiltration control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:34
Protective system for ultrafiltration . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:35Power failure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:38
Returning the blood during a power failure . . . . . . . . . . . . . . . . . . . . . 3:38Battery back-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:38Recovery from a short power failure . . . . . . . . . . . . . . . . . . . . . . . . . . 3:39
Recirculation during treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:40Reconnection of the patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:40
Change of blood pump segment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:42BiCart/SelectCart change during treatment . . . . . . . . . . . . . . . . . . . . . . . . 3:43
4. Hemodialysis, double needle treatment
Double needle treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:2Check before starting the machine . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:2
Start the machine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:2Function check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:3Select concentrates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:4Connect concentrates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:6
SelectCart and SelectBag together with BiCart . . . . . . . . . . . . . 4:7Acidic concentrate and BiCart . . . . . . . . . . . . . . . . . . . . . . . . . . 4:8Acidic concentrate and liquid bicarbonate concentrate . . . . . . . 4:8Acetate concentrate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:8
Start the machine - continued . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:9Attaching the dialyzer and the blood lines . . . . . . . . . . . . . . . . . . . . . . 4:11
Dialyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:11
Arterial blood line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:12Preparations if the heparin pump is to be used . . . . . . . . . . . . . 4:14
Venous blood line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:16Priming . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:17
Priming and rinsing the extracorporeal circuit . . . . . . . . . . . . . . . . 4:17Initiating . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:19
Set the treatment parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:19Connect the patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:20
Start the treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:21Pressure alarm limits setting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:22
Venous/Arterial pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:22
TMP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:22Discontinuing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:24Automatic emptying of BiCart, SelectCart and SelectBag . . . . . . . . 4:24Discontinuing procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:25
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Confirm treatment end . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:25If desired, start emptying BiCart or BiCart, SelectCart andSelectBag . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:25Return the blood . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:25
After-treatment handling of the machine . . . . . . . . . . . . . . . . . . 4:26
5. Hemodialysis, single needle treatment
Single needle treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:2General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:2
Glossary of single needle parameters and key terms . . . . . . . . . . . . 5:3Single needle treatment with two blood pumps - BM 202 only . . . . . . . . . 5:4
Preparations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:4Arterial blood line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:4Venous blood line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:5
Priming . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:6Priming and rinsing the extracorporeal circuit . . . . . . . . . . . . . . . . 5:6
Priming and rinsing procedure in double needle mode, finishingin single needle/double pump mode . . . . . . . . . . . . . . . . . . . . . 5:6Priming and rinsing procedure in single needle/double pumpmode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:9
Initiating . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:11Set the treatment parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:11
Always check/adjust . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:11Connect the patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:12
Start the treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:13Pressure alarm limits setting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:15
TMP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:15
Venous/Arterial pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:15Discontinuing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:17
Single needle treatment with one blood pump . . . . . . . . . . . . . . . . . . . . . 5:18Preparations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:18
Single needle / single pump settings . . . . . . . . . . . . . . . . . . . . . . . . 5:19Connect the patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:19
For both pressure- and time-controlled phases . . . . . . . . . . . . . 5:19Start the treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:21
For both pressure- and time-controlled phases . . . . . . . . . . . . . 5:21Only for pressure-controlled phases . . . . . . . . . . . . . . . . . . . . . 5:21Only for time-controlled phases . . . . . . . . . . . . . . . . . . . . . . . . 5:22
Discontinuing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:23Double needle to single needle treatment - change during treatment . . 5:24
Resume treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:24Single needle / single pump settings . . . . . . . . . . . . . . . . . . . . . . . . 5:24
Only for pressure-controlled phases . . . . . . . . . . . . . . . . . . . . . 5:25Only for time-controlled phases . . . . . . . . . . . . . . . . . . . . . . . . 5:26
Discontinuing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:27
6. Isolated UF
7. Profiling
Profiling of Na+ and HCO3- dialysis fluid concentration . . . . . . . . . . . . . 7:2Profiling of ultrafiltration rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7:4
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Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7:5Curve Setting/Change/Cancellation: . . . . . . . . . . . . . . . . . . . . . 7:5
Activation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7:5Verification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7:5
Activation of profiling with already preset models . . . . . . . . . . . . . . . . 7:7
Verifi
cation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7:7
8. Hemodiafiltration, low volume
General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:2Protective system for low volume HDF . . . . . . . . . . . . . . . . . . . . . . . . 8:2
The following conditions have to be met in order to fulfil theaccuracy of the measuring system . . . . . . . . . . . . . . . . . . . . . . . . . . 8:3
Start up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:4Priming and rinsing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:6Initiating and starting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:7
Bolus infusion possibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:8Hemodiafiltration, low volume, single needle, single pump . . . . . . . . . 8:8
9. BVS - Blood Volume Sensor
General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9:2BV text information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9:3
Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9:4Graphs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9:5BVS ON/OFF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9:6
BVS Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9:6BVS On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9:7
10.BPM - Blood Pressure Monitor option
General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10:2Patient factors which affect readings . . . . . . . . . . . . . . . . . . . . . . . . . . 10:3Handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10:5
The BPM screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10:6BPM button pressed once . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10:6BPM button pressed twice . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10:7
Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10:8Alarm limits setting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10:8
Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10:9Start/Stop . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10:10
Start . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10:10Stop . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10:10
11.Diascan
General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:2Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:2How the measuring process is performed by the machine . . . . . . . . . . 11:2Glossary of Diascan parameters and key terms . . . . . . . . . . . . . . . . . . 11:3
Precautions before use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:4Handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:5Screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:5
The first screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:6
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Measurement mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:6Alarm limit for clearance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:6Measurement result values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:7
The second screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:8Distribution volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:8
Distribution volume calculation using the Watson formula . . . . 11:9Forecast . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:10Target . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:10Alarm limit for Kt/V . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11:10Measurement result values when distribution volume has not beenset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:11Second screen symbol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:11Measurement result values when distribution volume has been set . 11:12
The third screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:13Latest measured values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:13
Accumulated and forecast values . . . . . . . . . . . . . . . . . . . . . . . . . .11:13Time to target . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:14Third screen symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11:14
Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:15Clearance alarm limit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11:15Kt/V alarm limit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11:15
Step-by-step instructions for measuring clearance and Kt/V . . . . . . . . . .11:16Single clearance measurement check . . . . . . . . . . . . . . . . . . . . . . . . . .11:16Continuous measuring of clearance . . . . . . . . . . . . . . . . . . . . . . . . . . .11:18Single Kt/V and clearance measurement check . . . . . . . . . . . . . . . . . .11:20Continuous measuring of Kt/V and clearance . . . . . . . . . . . . . . . . . . .11:22
12.Hygiene and maintenance
General hygiene and maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:2Glossary of disinfection terms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:3Disinfection history . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:4
List of disinfection screen symbols . . . . . . . . . . . . . . . . . . . . . . . . . 12:4Schedule for hygiene and maintenance . . . . . . . . . . . . . . . . . . . . . . . . . 12:6
When the machine is planned not to be in use . . . . . . . . . . . . . . . . 12:7Characteristics of different disinfection, decalcification and cleaningagents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:8
Hygiene - Heat disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:9General - Heat disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:9
Performing Heat disinfection program . . . . . . . . . . . . . . . . . . . . . . . .12:11Performing Heat disinfection program with CleanCart . . . . . . . . . . . . 12:12Performing Heat disinfection program with liquid citric acid . . . . . . .12:13Performing integrated Heat disinfection program with WRO 300 H . .12:14
Automatic start of Heat disinfection program . . . . . . . . . . . . . . . . . . .12:16Automatic switch off after Heat disinfection program . . . . . . . . . . . . .12:17Integrated Heat disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:17
Hygiene - Chemical disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:18General - Chemical disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12:18Chemical disinfectants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:19Performing Chemical disinfection program . . . . . . . . . . . . . . . . . . . . .12:20
Filling the machine with chemical disinfectant . . . . . . . . . . . . . . . . 12:21Residual test after Chemical disinfection . . . . . . . . . . . . . . . . . . . . . . .12:23Central Chemical disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12:24Performing central Chemical disinfection . . . . . . . . . . . . . . . . . . . . . .12:24
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Hygiene - Rinse/Drain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:25Performing Rinse/Drain program . . . . . . . . . . . . . . . . . . . . . . . . . . . .12:25Performing Rinse/Drain program with CleanCart . . . . . . . . . . . . . . . .12:26
Automatic start of Rinse/Drain program . . . . . . . . . . . . . . . . . . . . . . .12:28Automatic switch off after Rinse/Drain program . . . . . . . . . . . . . . . .12:29
Maintenance - thefl
ow path . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12:30The flow path . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:30Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:30Decalcification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12:30
Ultrafilter; how to change . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12:31Ultrafilter replacement reminder . . . . . . . . . . . . . . . . . . . . . . . . . . .12:32
Maintenance - the exterior of the machine . . . . . . . . . . . . . . . . . . . . . . . .12:33The outside . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:33Top tray . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:33Blood pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:33Blood leak detector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:33BPM cuff . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:34
13.Technical data and specifications
Performance and specification - Control System . . . . . . . . . . . . . . . . . . . . 13:2Blood Flow Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:2
Air Detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:3Heparin Administration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:3Blood Volume Sensor (BVS) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:3Blood Pressure Monitor (BPM) . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:3Dialysis fluid preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:4Dialysis fluid preparation (BiCart Select mode only) . . . . . . . . . . . . 13:5
Ultrafiltration control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:5Substitution fluid (Low volume HDF) . . . . . . . . . . . . . . . . . . . . . . 13:5Profiling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:5Diascan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:6Disinfection and Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:6
Water supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:9Drain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:10Power supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:10Connection of external equipment . . . . . . . . . . . . . . . . . . . . . . . . .13:10Battery Back-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:12
Performance and specification - Supervisory system . . . . . . . . . . . . . . . . .13:13
Blood Pressure Supervision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13:13Air Detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:14Heparin Administration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13:14Dialysis fluid preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13:14Dialysis fluid preparation (BiCart Select mode only) . . . . . . . . . . . .13:14Ultrafiltration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13:15Substitution fluid (Low volume HDF) . . . . . . . . . . . . . . . . . . . . . .13:15Blood leak detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:15
Physical data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:16References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:16
Materials in contact with water, concentrates and dialysis fluid . . . . . . . . .13:17
Polymers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:17Metals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:17Others . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:17
Environmental data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13:18
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Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13:18Transportation and storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13:18Electromagnetic environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13:18
Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:22
14.Alarm list, Attention alarm list and Technical alarm
list
Alarm list . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14:2Attention alarm list . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14:9Technical alarm list . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14:45
15.Major changes in operators manual
16.Index
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Figures
2. Description - the machine and its components
Figure 2:1 Blood monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2:2Figure 2:2 Fluid monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2:4
Figure 2:3 Rear of the machine - without options . . . . . . . . . . . . . . . . . 2:6Figure 2:4 Rear of the machine, options included . . . . . . . . . . . . . . . . . 2:8Figure 2:5 Monitor stand,five fixed positions . . . . . . . . . . . . . . . . . . . . 2:10Figure 2:6 Monitor stand, electrically adjustable . . . . . . . . . . . . . . . . . . 2:12
3. Controlling the machine - general guidelines
Figure 3:1 Operators panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:3Figure 3:2 Concentrate stand-by mode, activation . . . . . . . . . . . . . . . . . 3:7Figure 3:3 Flow diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:10Figure 3:4 Treatment overview screen . . . . . . . . . . . . . . . . . . . . . . . . . . 3:24
Figure 3:10 Function check overview screen . . . . . . . . . . . . . . . . . . . . . 3:26Figure 3:11 Temp button and the information display . . . . . . . . . . . . . 3:28Figure 3:13 Temp button and the information display . . . . . . . . . . . . . 3:29Figure 3:14 Downloading treatment parameters . . . . . . . . . . . . . . . . . . 3:32
4. Hemodialysis, double needle treatment
Figure 4:1 Select Bicarbonate and type of concentrate . . . . . . . . . . . . . 4:4Figure 4:2 Select SelectBag . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:5Figure 4:3 Connect the SelectCart cartridge and the SelectBag . . . . . . . 4:7Figure 4:4 Arterial blood line in HD, set-up . . . . . . . . . . . . . . . . . . . . . 4:13
Figure 4:5 Change position of the heparin pump holder . . . . . . . . . . . . 4:14Figure 4:6 Syringe attached to heparin pump . . . . . . . . . . . . . . . . . . . . 4:14Figure 4:7 Venous blood line in HD, set-up . . . . . . . . . . . . . . . . . . . . . 4:16
5. Hemodialysis, single needle treatment
Figure 5:1 Arterial blood line with expansion chamber in HD, singleneedle/double pump, set-up . . . . . . . . . . . . . . . . . . . . . . . . 5:4
Figure 5:2 Venous blood line with expansion chamber in HD, singleneedle/double pump, set-up . . . . . . . . . . . . . . . . . . . . . . . . 5:5
Figure 5:5 Venous blood line with attached expansion chamber in HD,
single needle/single pump, set-up . . . . . . . . . . . . . . . . . . . . 5:18
7. Profiling
Figure 7:1 3 different graphs for profiling sodium and bicarbonate . . . 7:2Figure 7:2 Profiling, Degressive graph . . . . . . . . . . . . . . . . . . . . . . . . . 7:3Figure 7:3 Profiling, Progressive graph . . . . . . . . . . . . . . . . . . . . . . . . . 7:3Figure 7:4 Linear graph for UF rate profiling . . . . . . . . . . . . . . . . . . . . 7:4
8. Hemodiafiltration, low volume
Figure 8:1 Infusion line in HDF low volume, set-up . . . . . . . . . . . . . . . 8:5
9. BVS - Blood Volume Sensor
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Figure 9:1 BVS, relative blood volume graph . . . . . . . . . . . . . . . . . . . . 9:3Figure 9:2 BVS, relative blood volume graph . . . . . . . . . . . . . . . . . . . . 9:4Figure 9:3 BVS, combination of graphs . . . . . . . . . . . . . . . . . . . . . . . . 9:5Figure 9:4 BVS, graphs without relative blood volume graph . . . . . . . . 9:6Figure 9:5 BVS turned on before the reference value has been acquired 9:7
Figure 9:6 BVS, the reference value not related to the treatment start . 9:7Figure 9:7 BVS, interrupted relative blood volume graph . . . . . . . . . . . 9:8
10.BPM - Blood Pressure Monitor option
Figure 10:1 BPM, screen with latest measured values and graph . . . . . . 10:6Figure 10:2 BPM, screen with the 8 latest measured values . . . . . . . . . . 10:7Figure 10:3 BPM, setting the alarm limits . . . . . . . . . . . . . . . . . . . . . . . 10:8Figure 10:4 BPM, measurement check in progress . . . . . . . . . . . . . . . .10:10
11.DiascanFigure 11:1 Diascan screens, without set distribution volume . . . . . . . . 11:5Figure 11:2 Diascan screens, set distribution volume . . . . . . . . . . . . . . 11:5Figure 11:3 First Diascan screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:6Figure 11:4 First Diascan screen with measurement result values . . . . . 11:7Figure 11:5 Second Diascan screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:8Figure 11:6 The Watson screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:9Figure 11:7 Second Diascan screen with set distribution volume . . . . .11:10Figure 11:8 Second Diascan screen with measurement result values,
distribution volume not set . . . . . . . . . . . . . . . . . . . . . . . . .11:11Figure 11:9 Second Diascan screen with measurement result values, set
distribution volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11:12
Figure 11:10 Third Diascan screen . . . . . . . . . . . . . . . . . . . . . . . . . . . .11:13Figure 11:11 Diascan, activated single measurement check . . . . . . . . . .11:16Figure 11:12 Diascan, activated continuous measuring . . . . . . . . . . . . .11:18Figure 11:13 Diascan, activated single measurement check . . . . . . . . . .11:20Figure 11:14 Diascan, distribution volume set . . . . . . . . . . . . . . . . . . . .11:21Figure 11:15 Diascan, activated continuous measuring . . . . . . . . . . . . .11:22Figure 11:16 Diascan, distribution volume, Kt/V target and alarm limit
set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:23
12.Hygiene and maintenance
Figure 12:1 Heat disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:11Figure 12:2 Auto Heat . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:16Figure 12:3 Chemical disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12:20Figure 12:4 Rinse/Drain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12:25Figure 12:5 Auto Rinse . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:28Figure 12:6 Ultrafilter replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . .12:32Figure 12:7 BPM cuff, removal procedure of rubber bladder from cloth
bag1. Small hole2. Large hole . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12:34
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Chapter 1
Before you get started - generalinformation
How to use this manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:2Definitions of expressions used in this manual . . . . . . . . . . . . . . . . . . 1:4
General precautions before use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:5Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:8Safety philosophy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:9
The preparation of dialysis fluid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:12Inlet water requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:12Preparation of the dialysis fluid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:12
UFD- Ultrafiltered Dialysis Fluid (option) . . . . . . . . . . . . . . . . . . . . . . 1:12Ultrafilters; frequency of change . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:12
List of concentrates, accessories and disposables, for use with theAK 200 S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:13
Concentrates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:13Lines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:14Dialyzers/Ultrafilter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:14Infusion fluid for low volume HDF . . . . . . . . . . . . . . . . . . . . . . . . 1:15Blood pressure measurement accessories . . . . . . . . . . . . . . . . . . . . 1:15
List of symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:16CE-marking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:18
Manufacturer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:18Copyright . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:18
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How to use this manual
Below is a brief explanation of how the chapters in this manual arestructured and are intended to be used.
Chapter 1; Before you get started - general informationThis chapter contains information to be read before using the AK 200 Smachine.
Chapter 2; Description - the machine and its components
This chapter contains component descriptions of the blood monitor, thefluid monitor, the rear of the machine and the monitor stands.
Chapter 3; Controlling the machine - general guidelines
This chapter contains explanations of how the machine is to becontrolled. This is, for example, how to use the buttons of the Operatorspanel, their alarms functions, how parameters are to be set and how touse the concentrate stand-by mode. The Treatment- and Function checkoverview screens are explained as well as the ultrafiltration control, andinformation is provided on what to do if a power failure occurs.
Chapter 4; Hemodialysis, double needle treatment
This chapter contains instructions on how to perform hemodialysis withtwo needles, using the AK 200 S machine. The chapter begins with howto start the machine and continues with how to attach the dialyzer andthe blood lines, the priming procedure, starting the treatment, setting ofparameters, and finishes with the discontinuing procedure.
Chapter 5; Hemodialysis, single needle treatmentThis chapter contains instructions on how to perform hemodialysiswith one needle, either using the double pump (if BM 202) or singlepump function. The chapter is based on chapter 4 with added specificinstructions for single needle treatment.
Chapter 6; Isolated UF
This chapter contains instructions on how to perform isolatedultrafiltration.
Chapter 7; Profiling
This chapter contains instructions on how to use the profiling functionfor ultrafiltration, as well as for the dialysis fluid concentration of sodiumand bicarbonate.
Chapter 8; Hemodiafiltration, low volume
This chapter contains instructions on how to perform low volumehemodiafiltration using the AK 200 S machine. The chapter is based onchapter 4 with added specific instructions for low volume HDF treatment.There is a general section describing the protective system for low volumeHDF, instructions for the bolus infusion possibility is also included.
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Chapter 9; BVS - Blood Volume Sensor
This chapter contains instructions on how to use the BVS, whichmeasures changes in the blood volume of the patient continuously duringtreatment. The chapter begins with a general section where handling,alarm function and graphs are explained, and finishes with On and Off
instructions.
Chapter 10; BPM - Blood Pressure Monitor
This chapter contains instructions on how to use the BPM (if installed),which measures blood pressure and pulse rate. A particular bloodpressure measurement cuff and a cuff hose are to be used. The chapterincludes explanations of how the BPM is handled using the BPM buttonand the BPM screens, and also describes the alarm function. The BPMcan be used manually if only one measurement check is to be done, orat set intervals during treatment.
Chapter 11; Diascan
This chapter contains instructions on how to use the Diascan function,which measures clearance (K) and dialysis dose (Kt or Kt/V). Thechapter is divided into two parts where the first section includes generalinformation about the Diascan function, handling using the Kt/V button,explanation of the Diascan screens, and alarm functions. The secondsection includes step-by-step instructions for measuring clearance andKt/V, single or continuous measuring.
Chapter 12; Hygiene and maintenance
This chapter contains information and instructions concerning thehygiene and maintenance of the AK 200 S that should be carried out by
the operator of the machine. The chapter begins with a general sectionwhere a schedule for hygiene and maintenance is included. The Hygienesections contain general information and instructions on how to performthe disinfection programs. The Maintenance sections include instructionson the maintenance of the flow path and the exterior of the machine.
Chapter 13; Technical data and specifications
This chapter contains technical specifications of the control- andsupervisory systems of the machine. It alsoincludes physical data;materials which come into contact with water, concentrates and dialysisfluid; environmental data; and a list of standards which the machine
complies with.
Chapter 14; Alarm list, Attention alarm list and Technical alarm list
This chapter contains lists of alarms, attention alarms and technicalalarms. The alarm list includes additional information and possible causesof parameter button alarms. The attention- and technical alarm listsinclude additional information concerning the alarms, describing thealarm text more in detail and giving suggestions about measures to take.The attention- and technical alarm lists are shown in alphabetical order.
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Chapter 15; Major changes in operators manual
This chapter includes brief information about major changes between thecurrent and previous program versions of the machine that have beenmade in the manual. The changes mentioned are mostly informationconcerning the operation of the machine and are specifically addressed
to the operator.
Note
A small reference number beside the figures in this manual has been
added to simplify manual production.
Note
Definitions of expressions used in this manual
W RNING
Is used to alert the user/operatornot to take a certain action, which
if taken can cause a potential hazard and result in a serious adverse
reaction, injury or death. A warning may also be used to alert the
user/operatorto take a certain action to avoid the potential hazard
as above.
W RNING
UTION
Is used to alert the user/operatorto take a certain action to protect
against a potential hazard which, if ignored, could have an adverseeffect on the patient or the device. A caution may also be used to
alert the user/operatornot to take a certain action to avoid the
potential hazard as above.
UTION
Note
A reminder to the user/operator on normal treatment activity and on
what is a suitable action in a particular situation.
Note
This symbol indicates that it is possible to preset the value of aparameter. This can be done to adapt the settings of the machine tocorrespond with the routines of the user/clinic. It has to be done inservice mode by an authorized service technician.All values mentioned in this manual are default values set in the machinewhen it was manufactured. It is important to check with the servicetechnician if values have been changed, and if so, which ones.For instance, it is possible to preset the machine for which mode to startup in, some alarm limits, some functions and options.
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General precautions before use
W RNING
Unauthorized modifications, alterations or repair and lack
of maintenance or calibration of the AK 200 S may result in
malfunctioning or have other serious consequences for the safeoperation of the equipment.
W RNING
UTION
The AK 200 S may only be operated by persons trained in
hemodialysis and who have studied the instructions in this manual.
The user/operator should draw special attention towards the text
valid for the Safety philosophy of the machine. See section "Safety
philosophy" in chapter 1. Verify that the first digit of the program
version of both the machine and the manual is the same. If the
AK 200 S does not perform as described in this manual, it shouldnot be used until the condition is rectified.
When unpacking, check the equipment for any signs of damage. If
the equipment is in any way damaged, proper operation can not
be assured.
Patients connected to the AK 200 S should be monitored by
competent medical personnel, learned intermediaries or the like,
since life threatening circumstances sometime arise that may not
activate alarms. The operator should pay attention to all appropriate
alarms and follow the instructions, warnings, cautions, and notes
given in this manual. It is imperative that the machine has passedthe function check before connecting a patient.
During installation all calibration checks must be completed before
the machine is used to dialyze a patient.
The AK 200 S needs special precautions regarding EMC and
needs to be installed and put into service according to the EMC
information provided in the "Technical data and specifications"
chapter in this manual.
The use of mobile telephones or communication equipment in the
vicinity of the AK 200 S could adversely influence the performanceof the machine. For further information, see the "Technical data and
specifications" chapter in this manual.
The AK 200 S will perform as designed only if it is used and
maintained in accordance with Gambros instructions. Any
warranties made by Gambro with respect to the AK 200 S 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.
UTION
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UTION
Preventive inspection, maintenance and calibration of the AK 200 S
shall be performed by a fully trained service technician according
to the Maintenance Manual in the AK 200 S Service Manual which
can be ordered from your Gambro representative. It is mandatory
for preventive maintenance to be performed at least every otheryear. Yearly maintenance is recommended. The interval between
preventive maintenance procedures might differ due to operating
environment variations.
The AK 200 S dialysis machine is in compliance with certain
requirements concerning patient leakage current from the dialysis
fluid in accordance with international standards and regulations.
When a central venous catheter is used, and the tip of the catheter is
close to the heart, it is however necessary to take extra precautions
to minimize the risk for arrythmia due to leakage currents. For these
treatments it is necessary to connect the potential equalization
conductor between the AK 200 S and the potential equalization busbar in the electrical installation.
To minimize the leakage currents from other electrical equipment it
is recommended to place such equipment outside the patient area.
Any equipment within the patient area shall fulfil the IEC 60601-1
and IEC 60601-1-1 standards and be a part of the potential
equalization. One way to minimize the leakage currents from
equipment within the patient area is to electrically isolate it. Make
sure leakage current values are below respective limit required by
CF type applied parts. Check with service technician.
If your clinic/hospital use a central venous catheter during
treatments please make sure your machine is equipped with apotential equalization connection. If not please contact your local
Gambro Service Technician for further assistance.
UTION
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Note
This operators manual provides instructions necessary for the proper
operation of the AK 200 S. It is not a guide for the administration
of hemodialysis.
Machines are not disinfected before delivery. Always perform a
chemical disinfection after installation, before initial use.
When accuracy ranges are written as e.g. (1 ml/min or 1%) the
widest range is valid.
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.
For the qualified technician the AK 200 S Service Manual is available.
The Service Manual provides all of the necessary information for
installation and safe and required maintenance of the machine.
It is important that the protective earth in the installation is of high
quality.
For the purpose of protecting the environment the AK 200 S 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 local Gambro distributor
for information.
Note
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Intended use
The Gambro AK 200 S System is designed to be used as a single patientmachine to perform hemodialysis treatments upon prescription by aphysician. Patient counselling and teaching of treatment techniques are
directly under the supervision and discretion of the physician.
The AK 200 S System comprises of two monitors; one blood monitor(BM 200 or BM 202) and one fluid monitor (FM 202). The monitors areplaced on a mobile stand (MS 200 or MS 202).
The blood monitor is designed to control and supervise the extracorporealblood circuit. Single needle treatment can be performed with one pump(double clamp function) or with two pumps (BM 202 only). To preventcoagulation, anticoagulantia may be administered by means of a heparinpump.
The fluid monitor is designed to produce the dialysis fluid at a desiredtemperature, conductivity and pressure within given specifications, andto supervise the dialysis fluid. Both acetate and bicarbonate treatmentscan be performed.
UTION
Patient education, counselling, home care follow-up and medical
maintenance must be performed under the direction of and
supervision by the physician prescribing the treatment. Gambro
specifically denies any responsibility for patient education,
counselling or home care and medical maintenance.
When AK 200 S is used to produce bicarbonate containing dialysis
fluid originating from non-liquid concentrates, the AK 200 S is
designed and validated for use with the Gambro BiCart system.
When AK 200 S is used to produce sodium chloride containing
dialysis fluid originating from non-liquid concentrates, the AK 200 S
is designed and validated for use with the Gambro BiCart Select
system, i.e. the SelectCart cartridge and SelectBag concentrate.
Gambro does not accept responsibility for use of other non-liquid
concentrate containers.
UTION
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Safety philosophy
The AK 200 S is designed according to the current standards forhemodialysis equipment, IEC 60601-2-16. This means that safety underso-called Single Fault Conditions is granted. In practice this means that
controllable treatment parameters (i.e. conductivity, temperature andultrafiltration) are controlled by one system, the control system, andmonitored by another completely separate protective system, utilizing itsown sensors, electrical circuits and microprocessors. The functionality ofthe protective system is checked by the AK 200 S before each treatment.A fault detection during the pre-treatment tests will make it impossible tostart the treatment.
In order to verify that the corresponding control and protective systemsare operating with the correct input values, the user is instructed tocompare the readings of the current bargraph display and the informationdisplay, before connecting the patient. The bargraph displays show the
set value, the actual value and the alarm limits for the control system,while the information display shows the corresponding values from theprotective system. If these comparisons are not satisfactory, call yourservice technician.
The protective system will, when a parameter (measured by the protectivesystem) is outside the alarm limits, put the AK 200 S into a patient-safecondition. This means that the protective system can stop the bloodpump, close the venous clamp, prevent the dialysis fluid from reachingthe dialyzer and alert the operator with sound and light.
The ultrafiltration control system, the UF-cell, control the ultrafiltrationvolume with an accuracy corresponding to 50 ml x passedtreatmenttime (h) or 2,5%. If the accumulated UF volume, measured by theUF-cell, differs more than 200 ml from the expected volume the machineissues an attention. In addition to this system there are independentultrafiltration measuring systems, protective systems, as described below.
In AK 200 S an independent ultrafiltration measuring system based onrestrictor flow measurement (FRN) is used as protective system for theUF-volume. For further description, see chapter 3. It is automaticallychecked before each treatment and a failure will make it impossible tostart the treatment.
The default alarm limit is set to 800 ml. The accuracy of the system is120 ml/h. This means that for a four hour treatment the maximumweight deviation without any alarm issued is less than 1280 g (800 + 4x 120). As an additional precaution it is recommended that competentpersonnel supervise the patient and that the blood pressure is checkedregularly.This protective system can be disabled via a preset. If this is done theremaining supervision is based on the transmembrane pressure, seefurther below for description of this system.
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As an extra precaution there is also a system for supervision of theUF-rate. This system is available on condition that the FRN system isnot disabled. The UF rate supervision is using the FRN system and themeasured UF rate is supervised against a limit. This limit constitutes themaximum allowed deviation between the UF rate measured by FRN and
the UF rate measured by the UF cell over a period of 2 minutes. Thedefault limit is set to 5 ml/min. The accuracy of the system is 2 ml/min.If this limit, i.e. 5 ml/min, is violated the system initiates a taration ofthe UF measuring system. If the limit is violated more than four timesduring 30 minutes, the machine terminates the treatment and a technicalerror is issued.
In addition, an independent ultrafiltration measuring system based onthe transmembrane pressure is used as protective system. Alarm limitsfor TMP related to the dialyzer UF coefficient and the expected UFrate, are to be set around the actual TMP value when starting treatment.The TMP alarm limit correspond to a UF-deviation limit described by
TMPAlarm limit x UFcoefficient. Example: If the alarm window is set to 50mmHg and the UF-coefficient is 10 ml/mmHg x h the maximum weightdeviations without any alarm is 500 g/h. Default the alarm window isset to 100 mmHg. It is essential to ensure that the alarm window is setas close as possible to the working TMP. As an additional precaution it isrecommended that competent personnel supervise the patient and thatthe blood pressure is checked regularly.
The composition of the dialysis fluid is supervised by the protectivesystem using an independent conductivity measuring system. The dialysisfluid conductivity and temperature systems are automatically checkedbefore each treatment. A failure will make it impossible to start thetreatment.
To protect the patient against a hazardous blood loss to the environmentthe AK 200 S incorporates a venous pressure monitoring system. Thissystem will react upon a change in the venous pressure, i.e when thepressure falls below the low alarm limit. It must be observed that undercertain pressure/flow conditions a blood loss to the environment maynot be able to cause the venous pressure to fall below the low alarm limit.To avoid blood loss to the environment it is essential to ensure that allconnections in the extracorporeal blood circuit are tight and secured, thatthe fistula needle is correctly positioned and secured and that the low
alarm limit is set as close as possible to the working venous pressure. Avisual monitoring by the user/operator is recommended.
The venous, arterial and system pressure measuring system is checkedautomatically at positive, atmospheric and negative pressure before eachtreatment. A failure will make it impossible to start the treatment.
The supervision of the stop time of the blood pump is the protectionsystem against patient blood loss due to coagulation during treatment.The operator will be notified via an attention alarm that the blood pumpstop time has been exceeded.
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The blood leak detector system, which utilizes an optical sensor, isautomatically tested before each treatment for being able to detecttransparency (no blood) and non-transparency (blood). If the systemcannot detect these states, it is impossible to start the treatment.Furthermore, the system is checked every 5 minutes to ensure that it is
able to detect non-transparency. If not, the system will act as if a bloodleak alarm has occurred and enter a patient safe condition.
The air detector utilizes an ultrasonic sensing system in which thetransmitter is handled by one microprocessor and the receiver by another.The system is continuously tested for being able to detect an air leakagecondition. If this test is not successful the system will act as if an airdetection has occurred and the machine will enter a patient safe condition.
If the AK 200 S is used to perform Hemodiafiltration, low volume, anindependent substitution flow supervision system is used as protectivesystem. It is based on restrictor measuring as well as pump speed
measuring. For the restrictor measuring it is essential that a correctinfusion line is used to obtain specified level of safety.
For a more detailed information, please refer to the AK 200 S ServiceManual.
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The preparation of dialysis fluid
Inlet water requirements
The chemical and microbiological quality of the water used to preparefluids for dialysis is an important factor for achieving and maintaining theproper quality of the dialysis fluid.
The quality of the water depends on the technical equipment for watertreatment. Further, proper maintenance of the water treatment systemand of the water distribution loop is essential.
The inlet water must comply with valid standards for water for dialysis;see chapter Technical data and specifications/Water supply in thismanual for more details.
Preparation of the dialysis fluid
The AK 200 S prepares dialysis fluid from inlet water and concentrates.
The dialysis fluid should be made from dry concentrates (such as theBiCart Select products) or from an acidic (A) concentrate and a drybicarbonate concentrate (such as the BiCart cartridge). It can alsobe made from an acidic (A) concentrate and a liquid bicarbonate (B)concentrate or from an acetate concentrate. See List of concentratesin this chapter.
UFD- Ultrafiltered Dialysis Fluid (option)
The AK 200 S can be equipped with a holder in which an ultrafiltercan be mounted. The ultrafilter purifies the dialysis fluid from possiblecontamination by bacteria and endotoxins.
Ultrafilters; frequency of change
The ultrafilter used in Ultrafiltered Dialysis Fluid kit is to be changed
regularly depending on the primaryfluid quality and the desired final fluidquality. The results from microbiological controls have to determinethe frequency of change. A frequency between once a month and onceevery three months can be expected.
For instructions on how to change the ultrafilter, see "Ultrafilter; howto change" in chapter 12.
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List of concentrates, accessories anddisposables, for use with the AK 200 S
This manual contains a number of references to concentrates, accessoriesand disposables for use with the AK 200 S. For ease of reference, set out
below is a comprehensive listing of such concentrates, accessories anddisposables as follows:
Concentrates
Liquid concentrates Area of use
001-099 series6xx series
Liquid acetate concentrates for preparationof acetate dialysis fluid.
2xx series
7xx series8xx series
Liquid A-concentrate for preparation of
bicarbonate dialysisfl
uid together withBiCart or with bicarbonate hemodialysisconcentrate D 200 (Sodium bicarbonate8,4 %).
3xx series Liquid A and B concentrates forpreparation of bicarbonate dialysisfluid.
SelectBag series Liquid A-concentrate for preparation ofbicarbonate dialysis fluid together withSelectCart and BiCart.
Non-liquid concentrates Area of use
BiCart Dry bicarbonate concentrate forpreparation of bicarbonate dialysis fluidtogether with proper liquid A-concentrateor SelectCart and SelectBag.
SelectCart Dry sodium chloride concentrate forpreparation of bicarbonate dialysis fluidtogether with SelectBag and BiCart.
UTION
Incorrect choice of dialysis fluid concentrate may cause incorrect
composition of the dialysis fluid.
UTION
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Lines
Line number Area of use
Gambro Medical Line (PVC+DOP/ EtO sterilized)
BL 10 series Arterial and venous blood line set.BL 100 series Arterial and venous blood line set.AV 100 series Arterial and venous blood line set.A 5000 series Arterial blood lines.V 5000 series Venous blood lines.
When performing low volume HDF, the venous blood line has to beequipped with a T/Y-connector.
Gambro Blood Tubing System (PVC+DOA/Beta sterilized)
BL 200 series Arterial and venous blood line set. Thearterial blood line has a cuvette when BVSis to be used.
When performing low volume HDF, the venous blood line has to beequipped with a T/Y-connector.
Gambro Accessories
C series Hemodialysis accessories.
C 705 A connection line with an expansionchamber. Used in single needle/singlepump mode.
C 200 HDF+EC Infusion line used in low volume HDF.
Dialyzers/Ultrafilter
Dialyzer/Ultrafilter Area of use
U 8000 S Ultrafi
lter used in Ultra Filtered DialysisFluid kit.
Dialyzers Most types of dialyzers, except platedialyzers, can be used. However, it isessential to verify that the specificationsand instructions for use of the dialyzersare not in discrepancy with those givenfor AK 200 S, with regards to e.g. therecommended priming procedure. Theconnectors and the ports of the dialyzermust comply with ISO 8637 and EN 1283.
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Infusion fluid for low volume HDF
Infusion solution Area of use
Hemofiltrasol 2x serie Infusion fluid used for low volumehemodiafiltration.
Blood pressure measurement accessories
Gambro Cuff Area of use
Standard No. 1 (7 cm) for 12 - 18 cm arm circumference.Standard No. 2 (9 cm) for 17 - 23 cm arm circumference.Standard No. 3 (12 cm) for 23 - 33 cm arm circumference.Standard No. 4 (14 cm) for 31 - 40 cm arm circumference.
Latex free Child for 18 - 26 cm arm circumference.
Latex free Adult for 25 - 35 cm arm circumference.Latex free Large for 33 - 47 cm arm circumference.
Single hand Child for 17 - 22 cm arm circumference.Single hand Adult for 22 - 32 cm arm circumference.Single hand Large for 32 - 42 cm arm circumference.
Gambro Cuff hose
3,5 m Cuff hose used for measuring bloodpressure together with the AK 200 S.
UTION
The AK 200 S has been tested and validated for use with the
concentrates, accessories and disposables specified above.
Gambro does not accept any responsibility or liability for use of
concentrates, accessories or disposables other than those specified
above. Depending on the circumstances, use of concentrates,
accessories or disposables other than those specified above may
also reduce Gambros warranties for the AK200 S.
UTION
Note
The user should make sure to have a current listing of concentrates,
accessories and disposables available.
The user should follow the facility procedures for proper disposal
of used blood lines, dialyzers and other disposables per local
regulations.
Note
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List of symbols
Note
All symbols in this list may not be represented on this product.
Note
Symbol Description
Alternating current
Protective earth (ground)
Warning, consult accompanyingdocuments
Off (power, disconnection from the mains)
On (power, connection to the mains)
Type B, applied part
Handle with care
This way up
Keep dry
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Symbol Description
Input /Output
Year of manufacturing
Heater power supply outlet
Conforms to requirements in EC CouncilDirective 93/42/EEC concerning medicaldevices. 0086 identifies BSI, BritishStandards Institution, as Notified Body.
CSA approved for Canada
CSA approved for Canada and USA
CSA-listed label manufacturer
Prohibited behaviour
Equipotentiality
Separate collection for electrical andelectronic equipment
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CE-marking
This product is CE-marked in accordance with the requirements in ECCouncil Directive 93/42/EEC of 14 June 1993 concerning medicaldevices and is classified as IIb equipment.
Notified body is: British Standards Institution (BSI) with the notifiedbody number 0086.
The CE-marking of this manual is only valid if the device which itdescribes is CE-marked.
Manufacturer
Gambro Lundia AB, Monitor Division,Box 10101, SE-220 10 LUND, Sweden.
Phone +46 46 169000.
Copyright
2001-2003, 2005 Gambro Lundia AB
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Chapter 2
Description - the machine and itscomponents
Blood monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2:2BM 200 - Single Pump, BM 202 - Double Pump . . . . . . . . . . . . . . . . . 2:2
Fluid monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2:4FM 202 - Acetate and Bicarbonate . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2:4
Rear of the machine - without options . . . . . . . . . . . . . . . . . . . . . . . . . . . 2:6Rear of the machine - options included . . . . . . . . . . . . . . . . . . . . . . . . . . . 2:8Monitor stand . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2:10
MS 200: Adjustable height: five fixed positions . . . . . . . . . . . . . . . . . . 2:10
MS 202: Electrically adjustable height . . . . . . . . . . . . . . . . . . . . . . . . . 2:12
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Blood monitor
BM 200 - Single Pump, BM 202 - Double Pump
Figure 2:1 Blood monitor
1. Top trayTo protect the machine against leakage the top tray must always beplaced on top of the machine.
2. Air detectorThe air detector head is designed for a drip chamber with a diameterof 22 mm. The ultrasonic air detector will detect air or foam in the
venous drip chamber.
3. Venous pressure transducer connector
4. Arterial pressure transducer connector
5. BVS - Blood Volume SensorAn arterial blood line with a cuvette is required.
6. Arterial blood pump
The blood pump will stop if the pump cover is opened. Duringa power failure the pump can be manually operated by use of thepump handle. It is only possible to turn the arterial blood pump inan anticlockwise direction.
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7. Heparin pump
The heparin pump can be programmed for different syringe sizes .Syringes shall comply with ISO 7886 - 2. Upon delivery the machineis programmed for a 30 ml Becton Dickinson syringe with a length
of 81,0 mm . Syringes of other volumes and brands can be
programmed.
8. Arterial line guide
9. Priming detector
The priming detector detects if there is blood in the venous bloodline. Before the priming detector detects blood certain alarms aresuppressed to facilitate the priming. Treatment time and accumulationof values will start when blood has been detected. The treatment timewill continue to count down as long as blood is detected.
10. Arterial and venous line clampsThe clamps close the arterial and venous lines in certain alarmsituations. The clamps are also used when performing single needledialysis.
11. Level adjustment buttons
The level in the venous drip chamber is adjusted by pressing or inthe right (blue) area. The level in the expansion chamber connected tothe system pressure transducer connector may be adjusted by pressingor in the left (gray) area.
When pressed and hold, the level adjustment buttons are active formaximum 6 seconds at a time. After this, the buttons need to bepressed again to further adjust the level.
12. System pressure transducer connector
The system pressure transducer can be used for:- Predialyzer (post pump) pressure- System pressure in Single needle double pump- Flow supervision in HDF treatment
13. Venous blood pump/infusion pump (BM 202 only)
The pump can be used as venous blood pump in hemodialysis singleneedle double pump. In low volume hemodiafiltration the pump isused as infusion pump for substitution fluid. The pump will stop ifthe pump cover is opened. During a power failure the pump can bemanually operated by use of the pump handle. It is only possible toturn the venous blood pump/infusion pump in a clockwise direction.
14. Expansion chamber holder
15. Operators panel
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Fluid monitor
FM 202 - Acetate and Bicarbonate
Figure 2:2 Fluid monitor
1. Disinfection ports for concentrate pick-up tubes
2. B pick-up tube marked blue-white
The B pick-up tube is used for intake of:- Bicarbonate concentrate- Acetate concentrate- Concentrated or diluted disinfectants
3. A pick-up tube marked red
The A pick-up tube is used for intake of acidic concentrate.
4. Dialysisfluid outlet (to dialyzer)
5. Dialysisfluid inlet (from dialyzer)
6. Safety coupling
7. Turnable dialyzer holder arm
8. Blood leak detector
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9. SelectBag holderThe machine is designed for use with the Gambro SelectBag, a bagcontaining electrolytes (except sodium chloride).
10. SelectCart holder
The machine is designed for use with the Gambro SelectCart, acartridge containing dry sodium chloride.
11. BiCart holder
The machine is designed to be used with Gambros BiCart System,a cartridge containing dry bicarbonate powder. During disinfectionmode, also used as a holder for CleanCart-C or CleanCart-A,cartridges containing a cleaning agent.
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Rear of the machine - without options
Figure 2:3 Rear of the machine - without options
1. BPM (Blood Pressure Monitor) connection
The line to the optional blood pressure cuff is connected to the nipple.
2. Potential equalization connection
This connection is used for the potential equalization conductor.When a central venous catheter is used, the conductor must beconnected to minimize the risk of electric shock. The connection ismarked with the symbol for equipotentiality (see List of symbolsin this manual).
3. Relay interface connection, marked yellow
4. GSS / PC connection, marked black
5. Optional connection, marked grey
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6. UF calibration unit connection, marked blue
7. Mains supply inlet
8. Main switch
9. Fuses
10. Power supply unit
11. Halt button
When the button is pressed the power supply to the AK 200 S isinterrupted. As soon as the button is released the power returns andthe machine performs a recovery.
12. Charging indicator
13. Drain outlet - from the machine
14. Water inlet
15. Heating vessel overflow
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Rear of the machine - options included
Figure 2:4 Rear of the machine, options included
1. BPM (Blood Pressure Monitor) connection
The line to the optional blood pressure cuff is connected to the nipple.
2. Potential equalization connection
This connection is used for the potential equalization conductor.When a central venous catheter is used, the conductor must beconnected to minimize the risk of electric shock. The connection ismarked with the symbol for equipotentiality (see List of symbolsin this manual).
3. Relay interface connection, marked yellow
4. GSS / PC connection, marked black
5. Optional connection, marked grey
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6. UF calibration unit connection, marked blue
7. Mains supply inlet
8. Main switch
9. Fuses
10. Power supply unit
11. Halt button
When the button is pressed the power supply to the AK 200 S isinterrupted. As soon as the button is released the power returns andthe machine performs a recovery.
12. Dialysis fluid filter (option)
13. Latch for filter change (option)
14. Drain air gap (option)
15. Charging indicator
16. Water inlet
17. Heating vessel overflow
18. Drain outlet - from the machine
19. Air gap (option)
20. Holder for the blood pressure measurement cuff (option)
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Monitor stand
MS 200: Adjustable height: five fixed positions
Figure 2:5 Monitor stand,fivefixed positions
1. Infusion pole
The maximum allowed load is 10 kg.
2. Height adjustment for infusion pole
3. Rear handle
4. Bars, lifting positionsPositions where the AK 200 S is safely lifted, both on the right andleft hand side of the machine.
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5. ScrewsFor locking the handle (service frame).
6. Screws (rear side)
For height adjustment in five fixed positions.
7. Tray for concentrate containers
8. Lockable wheels
The wheels must be locked during treatment. During internaltransportation the AK 200 S must be in upright position.
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MS 202: Electrically adjustable height
Figure 2:6 Monitor stand, electrically adjustable
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 is safely lifted, both on the right and
left hand side of the machine.
5. Screws
For locking the handle (service frame).
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6. Control for height adjustment
7. Power supply cordFor height adjustable stand only.
8. Tray for concentrate containers
9. Lockable wheels
The wheels must be locked during treatment. During internaltransportation the AK 200 S must be in upright position.
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Chapter 3
Controlling the machine - generalguidelines
Operators panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:2Hygiene group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:4Mode group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:5
Concentrate stand-by mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:6Procedure for manual activation . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:7Resume fluid preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:7
Therapy group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:9Treatment overview group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:10
Bargraph display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:10Flow diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:10
Time display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:11Parameter buttons and their displays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:12
Reset possibilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:16Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:17
Alarm indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:17Alarm function of the parameter buttons . . . . . . . . . . . . . . . . . . . . . . . 3:18
Override possibilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:20Stand-by group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:22Display and setting group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:23
Information display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:23Treatment overview screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:24
Parameters shown on Treatment overview screen . . . . . . . . . . . . . . . . 3:25Function check overview screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:26
Tests shown on Function check overview screen . . . . . . . . . . . . . . . . . 3:27The eight commandments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:28Setting of parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:29Downloading treatment parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:32
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:33The ultrafiltration control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:34
Protective system for ultrafiltration . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:35Power failure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:38
Returning the blood during a power failure . . . . . . . . . . . . . . . . . . . . . 3:38Battery back-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:38Recovery from a short power failure . . . . . . . . . . . . . . . . . . . . . . . . . . 3:39
Recirculation during treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:40Reconnection of the patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:40
Change of blood pump segment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:42BiCart/SelectCart change during treatment . . . . . . . . . . . . . . . . . . . . . . . . 3:43
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Operators panel
Both the blood monitor and the fluid monitor are controlled andsupervised from the operators panel. The panel consists of a number ofbuttons, bargraph displays, flow paths, a time display, an information
display, a bloodfl
ow knob and one set knob.
The panel is divided into six logical groups:
1. Hygiene group
These buttons are used to select machine modes mainly related todisinfection, rinsing and draining of the fluid monitor.
2. Mode group
The buttons in this group are used to select different treatment modes.
3. T