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AK 95 S Operator's manual, valid for

program version 10.xx


1. Before you get started - general information
2. Description - the machine with its components
3. Controlling the machine - general guidelines
4. Treatment operations
5. Auto priming, Rinse-back
6. BPM - Blood Pressure Monitor (option)
7. Disinfection and cleaning, Auto heat, Auto rinse
8. Technical data and specifications
9. Alarm lists
10. Major changes
11. Index

HCEN9794 Revision.08.2003
Program version 10.xx

Contents
1. Before you get started - general information
Definitions of expressions used in this manual . . . . . . . . . . . . . . . . . .
General precautions before use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Safety philosophy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Inlet water requirements and frequency of filter exchange . . . . . . . . .
Ultra Filtered Dialysis Fluid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
List of concentrates, accessories and disposables, for use with the
AK 95 S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
List of symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
CE-marking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Manufacturer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1:2
1:3
1:5
1:6
1:8
1:9
1:10
1:13
1:15
1:15

2. Description - the machine with its components


Blood unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Fluid unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Mixing unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Rear of the machine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2:2
2:4
2:6
2:8

3. Controlling the machine - general guidelines


Operator's panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Hygiene group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Mode group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Treatment overview group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Flow diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Mode buttons and Parameter buttons and their displays . . . . . . . . . . .
Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Alarm indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Air detector alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Attention alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Technical message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
pH alarm (option) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Blood leak alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
BPM alarm (option) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Alarm function of the parameter buttons . . . . . . . . . . . . . . . . . . . .
Venous pressure alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Centralizing alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Blood pump alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Single needle data alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Temperature alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Conductivity alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Arterial pressure alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Centralizing alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Transmembrane pressure alarm . . . . . . . . . . . . . . . . . . . . . . . . . . .
Centralizing alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Clinic Automation alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
UF volume alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
UF rate alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Heparin pump alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Time attention alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3:4
3:6
3:7
3:8
3:8
3:9
3:15
3:15
3:15
3:15
3:15
3:15
3:15
3:15
3:16
3:16
3:16
3:16
3:16
3:16
3:16
3:16
3:16
3:16
3:17
3:17
3:17
3:17
3:17
3:17
HCEN9794 Revision.08.2003
Program version 10.xx

Override possibilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Stand-by group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Display and setting group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Information display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Viewing Angle Adjustment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
The eight commandments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Setting of parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
The following parameters can be set: . . . . . . . . . . . . . . . . . . . . . . .
Chemical disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Heat disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Rinse/Drain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Acetate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Bicarbonate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Venous pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Blood flow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Single needle data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Temperature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Conductivity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Arterial pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
TMP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
UF volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
UF rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Heparin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
BPM (option) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Setting of the pressure alarm limits . . . . . . . . . . . . . . . . . . . . . . . . . . .
The ultrafiltration control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Recovery from power failure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Returning the blood during a power failure . . . . . . . . . . . . . . . . . .
Change of blood pump segments . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3:18
3:19
3:21
3:21
3:21
3:23
3:24
3:25
3:25
3:25
3:25
3:25
3:25
3:25
3:25
3:25
3:25
3:26
3:26
3:26
3:26
3:26
3:26
3:26
3:26
3:27
3:28
3:29
3:30
3:31

4. Treatment operations
Initial procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
First check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Start the machine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
For acetate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
For bicarbonate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Attaching the filter and the blood lines . . . . . . . . . . . . . . . . . . . . . . . .
Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Arterial blood line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Venous blood line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Dialysis fluid tubes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Priming and rinsing the extracorporeal circuit . . . . . . . . . . . . . . . . . . .
Before priming . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
High venous pressure test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Initiating dialysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Setting of treatment parameters . . . . . . . . . . . . . . . . . . . . . . . . . . .
Connect the patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Start of ultrafiltration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Set the alarm limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
BPM (option) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
High arterial pressure alarm limit setting . . . . . . . . . . . . . . . . . . . .
Minimize the risk of generating microbubbles . . . . . . . . . . . . . .

HCEN9794 Revision.08.2003
Program version 10.xx

4:2
4:2
4:3
4:4
4:4
4:5
4:5
4:6
4:10
4:10
4:12
4:12
4:14
4:15
4:15
4:15
4:17
4:17
4:18
4:18
4:19

Single needle treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .


Isolated UF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Discontinuing dialysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Returning the blood . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Emptying and disconnecting the filter . . . . . . . . . . . . . . . . . . . . . .

4:20
4:23
4:24
4:24
4:25

5. Auto priming, Rinse-back


Auto priming (Option) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
General description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Filling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Pressure test (Option) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Priming . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Flushing part one . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Flushing part two . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Venous drip chamber level adjustment (Option) . . . . . . . . . . . . . . .
Filling of venous line (Option) . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Dialysis fluid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Operation of the autopriming . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Rinse-back . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
General description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Operation of the Rinse-back . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5:2
5:2
5:2
5:2
5:2
5:2
5:3
5:3
5:3
5:3
5:4
5:9
5:9
5:9

6. BPM - Blood Pressure Monitor (option)


General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:2
The cuff . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:2
Handling BPM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:2
Patient factors affecting readings . . . . . . . . . . . . . . . . . . . . . . . . . . 6:3
Menus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:4
The first menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:4
The second menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:5
The third menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:5
Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:6
Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:7
Manual - single measuring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:8
Automatic - interval measuring . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:9
Continuous - five minutes measuring . . . . . . . . . . . . . . . . . . . . . . . 6:11
BPM Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:13

7. Disinfection and cleaning, Auto heat, Auto rinse


Disinfection - general . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Heat disinfection and Decalcification . . . . . . . . . . . . . . . . . . . . . . . . .
Performing heat disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Properties of different disinfection, decalcification and cleaning agents
Chemical disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Automatic start of heat disinfection or rinsing program . . . . . . . . . . . .
Chemical disinfection procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Residual test after chemical disinfection . . . . . . . . . . . . . . . . . . . .
Cleaning - general . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Calcium carbonate precipitates . . . . . . . . . . . . . . . . . . . . . . . . . . .
Organic fouling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Iron fouling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

7:2
7:4
7:5
7:7
7:8
7:10
7:12
7:13
7:15
7:15
7:15
7:15
HCEN9794 Revision.08.2003
Program version 10.xx

General guidelines for maintenance of the flow path . . . . . . . . . . .


Central disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Performing central disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . .
Rinse/Drain procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Rinse/Drain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
External cleaning of the machine . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Chemical disinfectants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Solutions based on peracetic acid . . . . . . . . . . . . . . . . . . . . . . . . . .
Sodium hypochlorite . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other disinfectants based on sodium hypochlorite . . . . . . . . . . . . .
Formaldehyde . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Exchange of ultrafilter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

7:16
7:17
7:17
7:18
7:18
7:19
7:21
7:21
7:22
7:22
7:22
7:23

8. Technical data and specifications


Performance and specification - Control system . . . . . . . . . . . . . . . . .
Blood flow control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Heparin administration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Blood pressure control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Blood Pressure Monitor (BPM) . . . . . . . . . . . . . . . . . . . . . . . . . . .
Dialysis fluid preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Ultrafiltration control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Disinfection and cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Water supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Power supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Connection of external equipment . . . . . . . . . . . . . . . . . . . . . . . . .
Performance and specification - Supervisory system . . . . . . . . . . . . .
Blood pressure supervision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Extracorporeal blood loss to the environment . . . . . . . . . . . . . . . .
Air detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Extracorporeal blood loss due to coagulation . . . . . . . . . . . . . . . . .
Dialysis fluid preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Ultrafiltration supervision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Blood leakage detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
pH-meter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Physical data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Dimensions and weight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Infusion stand . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Materials in contact with dialysate, concentrates and water . . . . . . . .
Environmental data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

8:2
8:2
8:2
8:3
8:3
8:3
8:5
8:5
8:7
8:8
8:9
8:10
8:10
8:10
8:10
8:10
8:10
8:11
8:11
8:11
8:12
8:12
8:12
8:13
8:14
8:14
8:15
8:16

9. Alarm lists
Alarm list . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9:2
Attention alarm list . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9:10
Technical alarm list . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9:41

10. Major changes


Major changes in operators manual from program version 9.xx to
10.xx . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10:2
HCEN9794 Revision.08.2003
Program version 10.xx

Complete manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Chapter 1 and 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Chapter 6 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Chapter 7 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Chapter 9 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
The minual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

10:2
10:2
10:2
10:2
10:2
10:2

11. Index

HCEN9794 Revision.08.2003
Program version 10.xx

Figures
2. Description - the machine with its components
Figure 2:1
Figure 2:2
Figure 2:3
Figure 2:4

Blood unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Fluid unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Mixing unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Rear of the machine . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2:2
2:4
2:6
2:8

3. Controlling the machine - general guidelines


Figure 3:1
Figure 3:2

Operator's Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Flow diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3:4
3:8

4. Treatment operations
Figure 4:3
Figure 4:4
Figure 4:5
Figure 4:6
Figure 4:9

Arterial blood line, set-up . . . . . . . . . . . . . . . . . . . . . . . 4:7


Change position of the heparin pump holder . . . . . . . . . 4:8
Syringe attached to the heparin pump . . . . . . . . . . . . . . 4:8
Venous blood line, set-up . . . . . . . . . . . . . . . . . . . . . . . . 4:11
Venous blood line with expansion chamber . . . . . . . . . . 4:20

6. BPM - Blood Pressure Monitor (option)


Figure 6:1
Figure 6:2
Figure 6:3
Figure 6:4
Figure 6:5
Figure 6:6
Figure 6:7
Figure 6:8

Information display, BPM, the first menu with measured


values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Information display, BPM, the first menu with previously
measured values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Information display, BPM, second menu . . . . . . . . . . . .
Information display, BPM, third menu . . . . . . . . . . . . . .
Information display, BPM, alarm limits set for systolic
blood pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Information display, BPM, performing single measurement
check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Information display, BPM, adjusting time intervals
between measurement checks . . . . . . . . . . . . . . . . . . . .
Information display, BPM, continuous measuring . . . . .

6:4
6:4
6:5
6:5
6:6
6:8
6:9
6:11

7. Disinfection and cleaning, Auto heat, Auto rinse


Figure 7:1

HCEN9794 Revision.08.2003
Program version 10.xx

BPM cuff, removal procedure of rubber bladder from


cloth bag
1. Small hole
2. Large hole . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7:20

This page is intentionally left blank

HCEN9794 Revision.08.2003
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Chapter 1
Before you get started - general
information
Definitions of expressions used in this manual . . . . . . . . . . . . . . . . . .
General precautions before use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Safety philosophy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Inlet water requirements and frequency of filter exchange . . . . . . . . .
Ultra Filtered Dialysis Fluid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
List of concentrates, accessories and disposables, for use with the
AK 95 S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
List of symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
CE-marking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Manufacturer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

HCEN9794 Revision.08.2003
Program version 10.xx

AK 95 S Operators manual - Before you get started

1:2
1:3
1:5
1:6
1:8
1:9
1:10
1:13
1:15
1:15

1:1

Definitions of expressions used in this


manual
WARNING
Is used to alert the user/operator not 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/operator to take a certain action to
avoid the potential hazard as above.

CAUTION
Is used to alert the user/operator to take a certain action to
protect against a possible hazard which, if ignored, could have
an adverse effect on the patient or the equipment. A caution
may also be used to alert the user/operator not to take a
certain action to avoid the potential hazard as above.

NOTE
A reminder to the user/operator on normal treatment activity
and on what is a suitable action in a particular situation.

1:2

AK 95 S Operators manual - Before you get started

HCEN9794 Revision.08.2003
Program version 10.xx

General precautions before use


WARNING
Unauthorized modifications, alterations or repair and lack
of maintenance or calibration of the AK 95 S may result in
malfunctioning or have other serious consequences for the safe
operation of the equipment.

CAUTION
1. The AK 95 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 95 S does not perform
as described in this manual, it should not be used until the
condition is rectified.
2. When unpacking, check the equipment for any signs of
damage. If the equipment is in any way damaged, proper
operation can not be assured.
3. Patients connected to life supporting equipment, such as the
AK 95 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 to check life supporting equipment
for proper operation before use.
4. During installation all calibration checks must be completed
before the machine is used to dialyse a patient.
5. The use of mobile telephones or communication equipment
in the vicinity of the AK 95 S could adversely influence the
performance of the machine.
6. The AK 95 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 95 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.

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AK 95 S Operators manual - Before you get started

1:3

CAUTION
7. The preventive inspections, maintenance and calibration of the
AK 95 S shall be performed according to the AK95/AK 95 S
Service Manual, Maintenance Manual HCEN9137 which
can be ordered from your Gambro representative. Periodic
maintenance should be performed after every 2500 hours of
operation or at least yearly.
8. When using central venous catheters, it is strongly
recommended that the potential equalization conductor
is connected to the dialysis machine and to the potential
equalization bus bar in the electrical installation to minimize the
risk of electric shock.
Any equipment within the patient area shall fulfil the IEC
60601-1 and IEC 60601-1-1 or equivalent safety standard, and
be a part of the potential equalization.

NOTE
1. This operators manual provides instructions necessary for
the proper operation of the AK 95 S. It is not a guide for the
administration of hemodialysis.
2. Machines are not disinfected before delivery. Always perform a
chemical disinfection after installation, before initial use.
3. When accuracy ranges are written as e.g. (1 ml/min or 1%)
the widest range is valid.
4. 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.
5. For the qualified technician the AK 95 S Service Manual is
available. The Service Manual provides all of the necessary
information for the safe and required maintenance of the
machine.
6. It is important that the protective earth in the installation is of
high quality.

1:4

AK 95 S Operators manual - Before you get started

HCEN9794 Revision.08.2003
Program version 10.xx

Intended use
The Gambro AK 95 S System is designed to be used as a single patient
machine to perform hemodialysis treatments upon prescription by a
physician. Patient counselling and teaching of treatment techniques are
directly under the supervision and discretion of the physician.
AK 95 S comprises of three units; one blood unit, one fluid unit and
one mixing unit.
The blood unit is designed to control and supervise the extracorporeal
blood circuit. Single needle treatment can be performed with one pump
(double clamp function). To prevent coagulation, anticoagulantia may
be administered by means of a heparin pump.
The fluid unit is designed to administer the dialysis fluid and to control
the ultrafiltration.
The mixing unit is designed to proportion concentrate(s) with reverse
osmosis water. Both acetate and bicarbonate treatments can be
performed.
CAUTION
1. 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.
2. When AK 95 S is used to produce bicarbonate containing
dialysis fluid originating from non-liquid concentrates, the
AK 95 S is designed and validated for use with the Gambro
BiCart system. Gambro does not accept responsibility for use
of other non-liquid concentrate containers.

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AK 95 S Operators manual - Before you get started

1:5

Safety philosophy
The AK 95 S is designed according to the current standards for
hemodialysis equipment, IEC 60601-2-16. This means that safety
under so-called Single Fault Conditions is granted. In practice this
means that controllable treatment parameters (i.e. conductivity,
temperature and ultrafiltration) are controlled by one system, the
control system, and monitored by another completely separate
protective system, utilizing its own sensors, electrical circuits and
microprocessors. The functionality of the protective system is checked
by the AK 95 S before each treatment. A fault detection during the
pretreatment tests will make it impossible to start the treatment.
In order to verify that the corresponding control and protective systems
are operating with the correct input values, the user is instructed
to compare the readings of the current bargraph display and the
information display, before connecting the patient. The bargraph
displays show the set value, the actual value and the alarm limits for
the control system. The information display shows the corresponding
values from the protective system. If the comparisons are not
satisfactory, call your service technician.
The protective system will, when a parameter (measured by the
protective system) is outside the alarm limits, put the AK 95 S into a
patient-safe condition. This means that the protective system can stop
the blood pump, close the venous clamp, prevent the dialysis fluid
from reaching the filter and alert the operator with sound and light.
For the ultrafiltration control system, the transmembrane pressure
(TMP) is used as the protective system. Alarm limits for TMP related
to the dialysis filter UF coefficient and the expected UF rate, 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 UFkoefficient. Example: If the alarm window is set to 50 mmHg
and the UF-koefficient is 10 ml/mmHg x h the maximum weight
deviations without any alarm is 500 g/h. As default the alarm window
is set to 100 mmHg. It is essential to ensure that the alarm window
is set as close as possible to the working TMP. As an additional
precaution it is recommended that competent personnel supervise the
patient and that the blood pressure is checked regularly.
To protect the patient against a hazardous blood loss to the environment
AK 95 S incorporates a venous pressure monitoring system. This
system will react upon a change in the venous pressure, i.e. when the
pressure falls below the low alarm limit. It must be observed that under
certain pressure/flow conditions a blood loss to the environment may
not 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 all connections in the extracorporeal blood circuit are tight and
secured, that the fistula needle is correctly positioned and secured and
that the low alarm limit is set as close as possible to the working venous
pressure. A visual monitoring by the user/operator is recommended.
The venous pressure measuring system is the protection against
blood loss to the environment. This measuring system is checked
automatically at 0 mmHg before each treatment. A failure will make it
1:6

AK 95 S Operators manual - Before you get started

HCEN9794 Revision.08.2003
Program version 10.xx

impossible to start the treatment. Furthermore, the user is instructed to


make a leakage test of the filter at a certain pressure.
The supervision of the stop time of the blood pump is the protection
system against patient blood loss due to coagulation during treatment.
The operator will be notified via an attention alarm that the blood
pump stop time has been exceeded.
The blood leak detector system, which utilizes an optical sensor, is
automatically tested before each treatment for being able to detect
transparency (no blood) and non-transparency (blood) before each
treatment. If the system cannot detect these states, it is impossible to
start the treatment.
The air detector utilizes an ultrasonic sound sensing system in which
the transmitter is handled by one microprocessor and the receiver is
handled by both microprocessors in the protective system. The system
is tested pre-treatment for parameter deviation in terms of sensitivity
change.
For a more detailed information, please refer to the AK 95 S Service
Manual.

HCEN9794 Revision.08.2003
Program version 10.xx

AK 95 S Operators manual - Before you get started

1:7

Inlet water requirements and frequency of


filter exchange
The feed water to AK 95 S must fulfil the AAMI requirements for
water for dialysis. The AAMI requirements include the following:
Chemical contaminants
Contaminant

Maximum allowable level (mg/l)

Calcium

Magnesium

Sodium

70

Potassium

Fluoride

0,2

Chlorine

0,5

Chloramines

0,1

Nitrate (N)

Sulphate

100

Copper

0,1

Barium

0,1

Zinc

0,1

Aluminium

0,01

Arsenic

0,005

Lead

0,005

Silver

0,005

Cadmium

0,001

Chromium

0,001

Selenium

0,09

Mercury

0,0002

1:8

Microbiological contaminants: Maximum 200 CFU/ml.

AK 95 S Operators manual - Before you get started

HCEN9794 Revision.08.2003
Program version 10.xx

Ultra Filtered Dialysis Fluid


The AK 95 S can be equipped with an ultrafilter holder in which an
ultrafilter U 8000 S can be mounted. The ultrafilter is placed in the
dialysis fluid circuit between the fluid preparation in AK 95 S dialysis
machine and the filter. The purpose is to purify the dialysis fluid from
possible contamination of bacteria and endotoxins. For exchange of
the ultrafilter see chapter 7.
NOTE
The U 8000 S filter used in Ultra Filtered Dialysis Fluid kit is
to be exchanged regularly depending on the primary fluid
quality and the desired final fluid quality. The results from
microbiological controls have to determine the frequency of
exchange. A frequency between once a month and once every
three months can be expected.

HCEN9794 Revision.08.2003
Program version 10.xx

AK 95 S Operators manual - Before you get started

1:9

List of concentrates, accessories and


disposables, for use with the AK 95 S
This manual contains a number of references to concentrates,
accessories and disposables for use with the AK 95 S. For ease
of reference, set out below is a comprehensive listing of such
concentrates, accessories and disposables as follows:
Concentrates
Liquid concentrates

Area of use

001-099 series
6xx series

Liquid acetate concentrates for


preparation of acetate dialysis fluid.

2xx series
7xx series
8xx series

Liquid A-concentrate for preparation of


bicarbonate dialysis fluid together with
BiCart or with bicarbonate hemodialysis
concentrate D 200 (Sodiumbicarbonate
8,4 %)

3xx series

Liquid A and B concentrates for


preparation of bicarbonate dialysis fluid.

Non-liquid concentrates

Area of use

BiCart

Dry bicarbonate concentrate for


preparation of bicarbonate dialysis
fluid together with proper liquid
A-concentrate.

CAUTION
Incorrect choice of dialysis fluid concentrate may cause
incorrect composition of the dialysis fluid.

1:10

AK 95 S Operators manual - Before you get started

HCEN9794 Revision.08.2003
Program version 10.xx

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.

Gambro Blood Tubing System (PVC+DOA/Beta sterilized)


BL 200 series

Arterial and venous blood line set.

Gambro Accessories
C series

Hemodialysis accessories.

C 705

A connection line with an expansion


chamber. Used in single needle mode.

Filters

HCEN9794 Revision.08.2003
Program version 10.xx

Filter name

Area of use

U 8000 S

Ultrafilter used in Ultra Filtered Dialysis


Fluid kit.

Dialysis filters

Most types of filters, except plate filters,


can be used. However, it is essential
to verify that the specifications and
instructions for use of the filters are
not in discrepancy with those given
for AK 95 S, with regards to e.g. the
maximum UF coefficient and the
recommended priming procedure. The
connectors and the ports of the filter must
comply with ISO 8637 and EN 1283.

AK 95 S Operators manual - Before you get started

1:11

Blood pressure measurement accessories


Gambro Cuff

Area of use

No.1 (7 cm)
No.2 (9 cm)
No.3 (12 cm)
No.4 (14 cm)

Cuffs used for measuring blood pressure


together with the AK 95 S.

Gambro Cuff hose


No.1 (3,5 m)
No.2 (1,5 m)

Cuff hoses used for measuring blood


pressure together with the AK 95 S.

CAUTION
1. The AK 95 S has been tested and validated for use with the
concentrates, accessories and disposables specified above.
2. 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
AK 95 S.

NOTE
1. The user should make sure to have a current listing of
concentrates, accessories and disposables available.
2. The user should follow the facility procedures for proper
disposal of used blood lines, dialyzers and other disposables
per local regulations.

1:12

AK 95 S Operators manual - Before you get started

HCEN9794 Revision.08.2003
Program version 10.xx

List of symbols
NOTE
All symbols in this list may not be represented on this product.

Description
Alternating current
Protective earth (ground)

Warning, consult accompanying documents

Off (power, disconnection from the mains)


On (power, connection to the mains)

Type B, applied part

Handle with care

This way up

Keep dry

Input /Output
Year of manufacturing

Heater power supply outlet


Conforms to requirements in EC Council Directive 93/42/EEC
concerning medical devices. 0086 identifies BSI, British Standards
Institution, as Notified Body.
CSA approved for Canada

HCEN9794 Revision.08.2003
Program version 10.xx

AK 95 S Operators manual - Before you get started

1:13

CSA approved for Canada and USA


CSA-listed label manufacturer

Prohibited behaviour
Equipotentiality

1:14

AK 95 S Operators manual - Before you get started

HCEN9794 Revision.08.2003
Program version 10.xx

CE-marking
This product is CE-marked in accordance with the requirements in EC
Council Directive 93/42/EEC of 14 June 1993 concerning medical
devices and is classified as IIb equipment.
Notified body is: British Standards Institution (BSI) with the notified
body number 0086.
The CE-marking of this manual is only valid if the device which it
describes is CE-marked.

Manufacturer
Gambro Lundia AB, Monitor Division,
Box 10101, SE-220 10 LUND, Sweden.
Phone +46 46 169000.
Copyright
Gambro Lundia AB, 1996

HCEN9794 Revision.08.2003
Program version 10.xx

AK 95 S Operators manual - Before you get started

1:15

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1:16

AK 95 S Operators manual - Before you get started

HCEN9794 Revision.08.2003
Program version 10.xx

Chapter 2
Description - the machine with its
components
Blood unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Fluid unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Mixing unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Rear of the machine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

HCEN9794 Revision.08.2003
Program version 10.xx

AK 95 S Operators manual - Description

2:2
2:4
2:6
2:8

2:1

Blood unit

1001

1
2

15
3
14
13
17

7
5
4
6

12
9
10
16

Figure 2:1

B
Acetate

11
8
10

Blood unit

1. Top tray
To protect the machine against leakage the top tray must always be
placed on top of the machine.
2. Operator's panel
As an option, the operator's panel can be mounted in an external
housing. The remote panel is easy to adjust in different positions
and the handling procedures will be the same.
3. Air detector
The air detector head is designed for a drip chamber with a diameter
of 22 mm. The ultrasonic air detector will detect air or foam in
the venous drip chamber.
4. Venous pressure transducer connector

2:2

AK 95 S Operators manual - Description

HCEN9794 Revision.08.2003
Program version 10.xx

5. Arterial pressure transducer connector


6. Arterial line guide
7. Blood pump
The blood pump will stop if the pump cover is opened. During a
power failure the pump can be manually operated by use of the
pump handle. It is only possible to turn the arterial blood pump
in an anticlockwise direction.
8. Heparin pump
The heparin pump can be programmed for different syringe sizes.
Syringes shall comply with ISO 7886-2.
9. Priming detector
The priming detector detects if there is blood or not in the venous
blood line. Before the priming detector detects blood certain
alarms are suppressed to facilitate the priming. Treatment time and
accumulation of values will start when blood has been detected.
The treatment time will continue to count down as long as blood
is detected.
10. Arterial and venous line clamps
The clamps close the arterial and venous lines in certain alarm
situations. The clamps are also used when performing single needle
dialysis.
11. Potential equalization connection
This connection is used for the potential equalization conductor.
When a central venous catheter is used, it is strongly recommended
that the conductor is connected to minimize the risk of
electric shock. The connection is marked with the symbol for
equipotentiality (see List of symbols in this manual).
12. Soft pac hook (option)
13. Filter holder
14. Level adjustment knob
The level in the venous drip chamber is adjusted by turning this
knob (anticlockwise to raise the level, clockwise to lower it).
15. Expansion chamber holder
16. BPM (Blood Pressure Monitor) connection (option)
The line to the blood pressure cuff is connected to the nipple.
17. Holder for the blood pressure measurement cuff (option)

HCEN9794 Revision.08.2003
Program version 10.xx

AK 95 S Operators manual - Description

2:3

Fluid unit

Figure 2:2

Fluid unit

1. Blood leak detector


2. Dialysis fluid outlet (to filter)
3. Dialysis fluid inlet (from filter)
4. Safety couplings
5. Ultra Filtered Dialysis Fluid kit (option)

2:4

AK 95 S Operators manual - Description

HCEN9794 Revision.08.2003
Program version 10.xx

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HCEN9794 Revision.08.2003
Program version 10.xx

AK 95 S Operators manual - Description

2:5

Mixing unit

8
6
5
4

1
2
8
7

1005

Figure 2:3

Mixing unit

1. Service frame
A service tray can be placed on top of the service frame if this is
pulled out.
2. Bars, lifting positions
Positions where the AK 95 S is safely lifted.
3. Wheels
Four wheels of which the two at the front side are lockable. The
brakes are not designed to hold the AK 95 S when it is tilted.
4. Tray for concentrate containers
Tray for the conentrate container(s).
5. BiCart holder
The machine is designed to be used with Gambro's BiCart system,
a cartridge containing dry bicarbonate powder.
During disinfection mode, also used as a holder for CleanCart-C
and CleanCart-A, cartridges containing a cleaning agent.
6. Red concentrate connector
This connector is used for the separately attached A-concentrate
pick-up tube (A pick-up tube).

2:6

AK 95 S Operators manual - Description

HCEN9794 Revision.08.2003
Program version 10.xx

7. Blue concentrate connector with white tube marking


This connector is used for the separately attached
B concentrate pick-up tube (B pick-up tube)

Acetate concentrate pick-up tube (B pick-up tube)

pick-up tube used for intake of concentrated or diluted


disinfectants

8. Disinfection ports for the concentrate connectors

HCEN9794 Revision.08.2003
Program version 10.xx

AK 95 S Operators manual - Description

2:7

Rear of the machine

1
2

8
3
4
5

1006

6
7

Figure 2:4

Rear of the machine

1. Infusion stand - the maximum allowed load is 2 kg


2. Height adjustment for infusion stand
3. Main switch
4. Interface connection
5. Appliance inlet
6. Water inlet
7. Drain
8. Fuses

2:8

AK 95 S Operators manual - Description

HCEN9794 Revision.08.2003
Program version 10.xx

Chapter 3
Controlling the machine - general
guidelines
Operator's panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Hygiene group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Mode group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Treatment overview group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Flow diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Mode buttons and Parameter buttons and their displays . . . . . . . . . . .
Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Alarm indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Air detector alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Attention alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Technical message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
pH alarm (option) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Blood leak alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
BPM alarm (option) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Alarm function of the parameter buttons . . . . . . . . . . . . . . . . . . . .
Venous pressure alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Centralizing alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Blood pump alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Single needle data alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Temperature alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Conductivity alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Arterial pressure alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Centralizing alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Transmembrane pressure alarm . . . . . . . . . . . . . . . . . . . . . . . . . . .
Centralizing alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Clinic Automation alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
UF volume alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
UF rate alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Heparin pump alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Time attention alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Override possibilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Stand-by group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Display and setting group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Information display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Viewing Angle Adjustment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
The eight commandments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Setting of parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
The following parameters can be set: . . . . . . . . . . . . . . . . . . . . . . .
Chemical disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Heat disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Rinse/Drain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Acetate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Bicarbonate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Venous pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Blood flow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Single needle data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Temperature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Conductivity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Arterial pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
HCEN9794 Revision.08.2003
Program version 10.xx

AK 95 S Operators manual - Controlling the machine

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3:1

TMP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
UF volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
UF rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Heparin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
BPM (option) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Setting of the pressure alarm limits . . . . . . . . . . . . . . . . . . . . . . . . . . .
The ultrafiltration control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Recovery from power failure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Returning the blood during a power failure . . . . . . . . . . . . . . . . . .
Change of blood pump segments . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3:2

AK 95 S Operators manual - Controlling the machine

3:26
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HCEN9794 Revision.08.2003
Program version 10.xx

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HCEN9794 Revision.08.2003
Program version 10.xx

AK 95 S Operators manual - Controlling the machine

3:3

Operator's panel
The blood unit, the fluid unit and the mixing unit are controlled and
supervised from the operator's panel. The panel consists of a number of
buttons, bargraph displays, flow paths, a time display, an information
display, a blood flow knob and one set knob.
The panel is divided into five logical groups:

Figure 3:1

Operator's Panel

1. Hygiene group
These buttons are used to select machine modes mainly related to
disinfection, rinsing and draining of the fluid unit and the mixing
unit.
2. Mode group
The buttons in this group are used to select different treatment
modes.
3. Treatment overview group
This group graphically shows the status of the treatment and allows
for a complete overview of all important treatment parameters.
3.1. Bargraph display
3.2. Flow diagram
3.3. Time display

3:4

AK 95 S Operators manual - Controlling the machine

HCEN9794 Revision.08.2003
Program version 10.xx

4. Stand-by group
These buttons can be used for direct control and stand-by of certain
functions.
5. Display and setting group
The two buttons and the set knob are used for setting of all
parameters except the blood flow. The blood flow is always directly
controlled with the blood flow knob. The information is shown on
the information display.
5.1. Information display
5.2. Blood flow knob
5.3. Set knob

HCEN9794 Revision.08.2003
Program version 10.xx

AK 95 S Operators manual - Controlling the machine

3:5

Hygiene group
The ON/OFF button is used to switch the machine on and off. The
main switch on the back side of the monitor should always be in the
ON position (even when the machine is not in use).
The machine can not be turned off during treatment, i.e. when
treatment time is not 0.00 and blood has been detected by the priming
detector. But if no blood has been detected by the priming detector the
machine can be turned off even if the time is not 0.00.
The Chem disinf button is used to select chemical disinfection. As
soon as the dwell time is completed, an automatic rinse will start. The
dialysis fluid tubes must be connected to the safety couplings when the
chemical disinfection mode is entered. The mode can not be selected
during treatment.
The Heat disinf button is used to select heat disinfection (heat
disinfection alone or in combination with a citric acid or CleanCart
disinfection). The dialysis fluid tubes must be connected to the safety
couplings when the heat disinfection mode is entered. The mode can
not be selected during treatment.
The Rinse/Drain button is used to select rinsing and draining mode. It
is also possible to discontinue the heat disinfection and the chemical
disinfection programs by pressing Rinse/Drain button. The dialysis
fluid tubes must be connected to the safety couplings when the rinse
or draining mode is entered. Rinse or drain can not be selected during
treatment.
The Auto Heat button is lit when auto heat has been programmed. The
machine performs a heat disinfection at a predetermined time, set by
the operator (auto heat alone or in combination with CleanCart).
The Auto Rinse button is lit when auto rinse has been programmed. The
machine performs a rinse at a predetermined time, set by the operator.
NOTE
The above mentioned buttons must be pressed for at least 3
seconds in order to activate/deactivate the functions

3:6

AK 95 S Operators manual - Controlling the machine

HCEN9794 Revision.08.2003
Program version 10.xx

Mode group
The Isol UF button is used to select isolated ultrafiltration (sequential
dialysis). The fluid preparation has to be completed in order to enter
the mode.
The SN button is used to select single needle treatment.
SN is performed by using the arterial and venous clamps, and may be
controlled and supervised by either time or pressure.
The Acetate button is used to select acetate treatment.

The Bicarbonate button is used to select bicarbonate treatment and


type of concentrate.
NOTE
The above mentioned buttons must be pressed for at least 3
seconds in order to activate/deactivate the functions.

The Volume control button is used to start the fluid preparation 1. The
function can be preset as active when the machine is switched on or it
can be activated manually by pressing the button. Once the function
is activated, it is not possible to deactivate it.

1
HCEN9794 Revision.08.2003
Program version 10.xx

Can be preset
AK 95 S Operators manual - Controlling the machine

3:7

Treatment overview group


Flow diagram
1-2 Blood path
The blood path lights red when the priming detector detects blood.
3-5-7 Bypass path
The bypass path lights green when the dialysis fluid is ready for
treatment. When the dialysis fluid is not correct the path is orange.
The machine will automatically bypass the filter during certain alarm
conditions and during self-calibration.
3-4-6-7 Filter path
The filter path lights green when dialysis fluid is passing through the
filter.
6 Ultrafiltration path
The ultrafiltration path lights yellow during isolated ultrafiltration and
in fluid bypass.

6
1036

3
Figure 3:2

3:8

Flow diagram

AK 95 S Operators manual - Controlling the machine

HCEN9794 Revision.08.2003
Program version 10.xx

Mode buttons and Parameter buttons and


their displays
Bargraph
display

Information
display

PERACE
3,5 %
HYPOCHL
10 %
FORMAL 37 %

Total disinfection time is


displayed on the TIME display
CITRIC 20 % Can be preset with combined
citric acid heat disinfection.
CLEANCART
Can be preset with combined
CleanCart heat disinfection.

RINSE

HCEN9794 Revision.08.2003
Program version 10.xx

Total disinfection time is


displayed on the TIME display
Three disinfection programs can
be preset

HEAT

Explanation

Rinse time in hours and minutes


(0-9:59) is displayed on the TIME
display
Rinse set time

TME NOW
XX 00.00
RDY DAY
XX
RDY TIME
00.00

Present day and time

TME NOW
XX 00.00
RDY DAY
XX
RDY TIME
00.00

Present day and time

The day of the week the auto heat


shall be finished
The time the auto heat shall be
finished

The day of the week the auto rinse


shall be finished
The time the auto rinse shall be
finished

AK 95 S Operators manual - Controlling the machine

3:9

Bargraph
display
-

Information
display

Explanation

ACC TIME
ACC UF

Accumulated isolated UF time


Accumulated volume in isolated
UF
Time for isolated UF
Set volume for total isolated UF

TIME
ISOL UF

The button is lit during single


needle mode

Yellow bar
Red bars

D01
D94
D53

Three types of concentrates can


be preset

The button is lit when the fluid


unit of the machine is running
(also during Isol UF)

D201
D360
D300

Three combinations of acid and


bicarbonate concentrates can be
preset

VEN PRES
LOW HIGH

Actual value
Alarm limits

In double needle mode


FLOW/ACC
Yellow bar

3:10

Red bars

LOW

Green Bar

SET
SEGMENT

Actual value/Accumulated
volume
Low alarm limit for the blood
flow delayed a presettable time
(0-60 min)
Set value
Blood pump segment diameter

AK 95 S Operators manual - Controlling the machine

HCEN9794 Revision.08.2003
Program version 10.xx

Bargraph
display

Information
display

In single needle mode


MEAN/ACC
Yellow bar
Red bars

LOW

Green bar

ART FLOW
SEGMENT MM

Actual mean blood


flow/Accumulated volume
Low alarm limit for the blood
flow of the arterial phase
Set value during the arterial phase
Blood pump segment diameter
mm

VEN
ART

Actual stroke volume in ml


Low alarm limit for the stroke
volume
Venous clamp opening time
Arterial clamp opening time

SET
TEMP
LOW HIGH

Set value
Actual value
Alarm limits

NA
SET COND
COND

Set value in mmol/litre


Calculated set value in mS/cm
Actual value in mS/Cm
Alarm limits (automatically set to
calculated value 5 %).

STROKE ML
LOW

Green bar
Yellow bar
Red bars

Explanation

In acetate mode
Green bar
Yellow bar
Red bars

In bicarbonate mode
NA, HCO3SET COND
Green bar
COND
Yellow bar
Red bars

HCEN9794 Revision.08.2003
Program version 10.xx

Set value in mmol/litre


Calculated set value in mS/cm
Actual value in mS/cm
Alarm limits (automatically set to
calculated value 5 %)

Yellow bar
Red bars

ART PRES
LOW HIGH

Actual value
Alarm limits

Yellow bar
Red bars

TMP
LOW HIGH

Actual value
Alarm limits

AK 95 S Operators manual - Controlling the machine

3:11

Bargraph
display

Information
display

Explanation

Clinic Automation
An external computer system
which is associated with patient
related information

.....
......
.......

When time or volume is set in isolated UF mode


Green bar
Shows set value for actual mode
ACC UF
Yellow bar
Accumulated ultrafiltration
TOT UF
Total set UF volume
UFR
Calculated UF

Yellow bar

ACC UF

Green bar

SET UF
UFR

Diffusion in priming mode


UF RATE
Yellow bar
DIA FIBER
PRIMING
MIN UF
Green bar
Red bars
Isol UF in blood mode
UF RATE
Yellow bar
DIA FIBER
ISOL
UFR
Green bar
MIN UF
Red bars
Diffusion in blood mode
UF RATE
Yellow bar
DIA FIBER
CALC
UFR
Green bar
MIN UF
Red bars

3:12

Accumulated ultrafiltration
volume
Set ultrafiltration value
Calculated UF

Actual value
Filter type
Priming UF rate
Minium UF rate
Calculated UF rate
Alarm limits

Actual value
Filter type
UF rate during isol UF
Minimum UF rate during
treatment
Alarm limits

Actual value
Filter type
Calculated UF rate
Minimum UF rate during
treatment
Alarm limits

AK 95 S Operators manual - Controlling the machine

HCEN9794 Revision.08.2003
Program version 10.xx

Bargraph
display

Information
display

Explanation

When the Priming light is on


attachment of the bloodlines and
priming and rinsing of the extra
corporeal circuit is possible. The
light goes out when the priming
detector has detected blood.

SET
ACC
STOP LIM

Set value in ml/h


Accumulated volume in ml
Stop limit indicating how long
time before end of treatment the
heparinization should stop

After attachment of the blood


lines, the button must be pressed
to select the auto priming mode

ACC VOL
SET VOL

Accumulated volume
Set volume

PASSED
The
TIME-display
always shows the
REMAINING
treatment time
(h.min) during
treatment
NON-DIFF
SET TIME
UFR

HCEN9794 Revision.08.2003
Program version 10.xx

Passed treatment time

Passed treatment time without


diffusion
Set treatment time
Calculated UF rate

AK 95 S Operators manual - Controlling the machine

3:13

Bargraph
display

Information
display

Explanation

When time or volume is set in isolated UF mode


PASSED
The
Passed treatment time
TIME-display
always shows the
REMAINING
treatment time
(h.min) during
treatment
NON-DIFF
Passed treatment time without
diffusion
TOT TIME
Total treatment time
UFR
Calculated UF rate
Disinfection or rinse mode
The
TIME-display
always shows the
ESTIMATED
REMAINING
disinfection/rinse
time (min) during
disinfection

3:14

Depending on which
disinfection/rinse program that is
being performed, the information
display will show different
displays. The information display
will show the different phases of
the program and the remaining
time of each phase.

AK 95 S Operators manual - Controlling the machine

HCEN9794 Revision.08.2003
Program version 10.xx

Alarms
Alarm indicators
The alarm indicators will light up in certain alarm situations. The Mute
button will flash and the buzzer will sound. Press the illuminated alarm
indicator to obtain further information on the information display.

Air detector alarm

Air has been detected in the venous drip chamber by the air detector.
When the button flashes, it indicates that the fault has been corrected.
Press the button in order to reset the alarm. During priming the button
may be lit, but as the air detector is not yet activated, the machine will
take no actions.
It is possible to deactivate the air detector in priming phase by pressing
the Priming button to exit the priming mode and to press the Priming
button once more to enter priming mode again.

Attention alarm

Attention or assistance is required from the operator. A small arrow in


the right corner of the information display indicates more information.
Press the button repeatedly for further information.

Technical message

A technical message has appeared. Press the button repeatedly for


further information on the information display. If necessary call your
service technician.

pH alarm (option)

The pH of the dialysis fluid is outside the limits.

Blood leak alarm

Blood has been detected by the blood leak detector. When the button
flashes, it indicates that the fault has been corrected. Press the button
to reset the alarm. During priming the button may light up, but, as
the blood leak detector is not yet activated, the machine will take no
actions.

BPM alarm (option)

Flashing light indicates that a measured blood pressure or pulse rate


value is outside the set alarm limits. The measured values outside the
set alarm limits will flash on the information display.
Press the MUTE button (which will light up) in order to mute the
buzzer and/or press the BPM button in order to confirm the alarm.
In order to adjust an alarm limit; see To set alarm limits below
Alarms in chapter 6.

HCEN9794 Revision.08.2003
Program version 10.xx

AK 95 S Operators manual - Controlling the machine

3:15

Alarm function of the parameter buttons


Certain parameter buttons also serve as alarm indicators for the
corresponding parameters. The parameter button/alarm indicator is
illuminated in alarm situations. In addition, the Mute button flashes
and the buzzer sounds.

Venous pressure alarm

Steady light
The venous pressure is outside the set limits.

Centralizing alarm

Flashing light
The venous pressure limits are too wide.

Blood pump alarm

Steady light
The blood pump stop time has expired.
or
The blood flow has been lower than the low alarm limit for more than
five minutes (default).

Single needle data alarm

Steady light
The stroke volume during SN is lower than the set low alarm limit.

Temperature alarm

Steady light
The temperature of the dialysis fluid is outside the set limits.

Conductivity alarm

Steady light
The conductivity of the dialysis fluid is outside the alarm limits.

Arterial pressure alarm

Steady light
The arterial pressure is outside the set alarm limits.

Centralizing alarm

Flashing light
The arterial pressure limits are too wide.

Transmembrane pressure alarm


Steady light
The TMP is outside the set alarm limits.

3:16

AK 95 S Operators manual - Controlling the machine

HCEN9794 Revision.08.2003
Program version 10.xx

Centralizing alarm

Flashing light
The TMP limits are too wide.

Clinic Automation alarm


.....
......
.......

Steady light
The connection to the external computer system has been interrupted.

UF volume alarm

Flashing light
The set UF volume is set to zero when the priming detector detects
blood.

UF rate alarm

Steady light
The UF rate is lower than the set minimum UF rate. Adjust the time,
the UF volume or the min UF.

Heparin pump alarm

Flashing light
The set heparin rate is set to zero when the priming detector detects
blood.

Time attention alarm

Flashing light
The treatment time has expired.

HCEN9794 Revision.08.2003
Program version 10.xx

AK 95 S Operators manual - Controlling the machine

3:17

Override possibilities
The alarm indicators for:

venous pressure, low limit

arterial pressure, low limit

air detector

blood leak

have an override function. In alarm situations it is possible to override


the alarm actions for a limited time. If the illuminated button is pressed
for 3 seconds the alarm actions will be overridden. Since an override
time limit (can be preset between 5-120 seconds, except for the
override of the air detector which is 0-120 seconds) is set, the alarm
actions will occur again if the fault is not corrected within this time. If
necessary, repeat the procedure.
When the override time limit for the air detector is preset to 0, the
corresponding alarm actions are not overridden and the override of the
air detector is cancelled.
Override of the air detector or the blood leak detector opens up both
venous pressure limits. During the override of the blood leak alarm, the
dialysis fluid rinses the blood leak detector and the fluid compartment
of the filter while the blood pump runs slowly. In treatment mode the
blood pump starts up at a flow rate of 50 ml/min during an override
of the air detector or the blood leak. However the blood flow can be
increased. If this is done, the blood flow will continue at 50 ml/min
when the alarm has been cleared.
In treatment mode the blood pump starts up at the set flow rate during
an override of the venous and arterial pressure low limit alarm.
In priming mode the blood pump starts up at the set flow rate value
during any override.
The alarm list (chapter 9) contains a list of all the AK 95 S alarms.
CAUTION
When entering an override mode it is essential to remember
that the machine does not monitor that specific parameter. The
operator is responsible for the monitoring during the override
time.

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HCEN9794 Revision.08.2003
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Stand-by group
The Blood pump button is used to start (constant light) and stop
(flashing light) the blood pump at the selected flow rate. If the blood
pump is stopped when the selected flow rate is 0 ml/min, the light of
the button goes out.
Pressing the Blood pump button (flashing) during treatment will
automatically widen the venous pressure, arterial pressure and TMP
alarm windows (flashing buttons). To centralize the alarm limits
around the actual values, press the corresponding flashing buttons. The
maximum permitted stop time for the blood pump during treatment is
1-3 min (can be preset). When this time has expired an attention alarm
will be activated instructing the operator to restart the pump, the buzzer
will sound and the Blood flow button will flash.
The Reset button is used to set the following accumulated values to
zero: UF volume, treated blood volume, heparin volume, Isol UF
volume, passed time and non-diffusion time. Also all parameters are
set to their preset values.
If a treatment is started and neither disinfection nor rinse have been
performed after the previous treatment, an attention alarm will be
given:

If the Reset button is pressed in this case, all accumulated values will
be set to zero but the parameters will not be set to their preset values.
If the Select arrow button is pressed neither accumulated values nor
parameters will be set to zero.
NOTE
1. No reset can be made if the blood pump has been started
and/or the Start/UF/Stop button has been pressed. In this case
the blood pump must be stopped and/or the Start/UF/Stop
button must be pressed again in order to make a reset.
2. No reset can be made during the test of the UF-cell. This has
to be done either before or after the test.

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The Mute button is used to silence the buzzer for varying times
depending on the alarm. The mute times for the different alarms are
shown in the alarm and the attention alarm lists (see chapter 9).
There are three kinds of buzzer sounds:

Soft: for most attention alarms:

Supersoft: for some attention alarms: - -(10 sec) - -(10 sec)

Continuous: for all other alarms:

By pressing the Mute button during treatment the ten most recent
treatment alarms can be displayed on the information display. The
information display sign must be extinguished and the buzzer must
not be active.
The most recent alarm will be shown first. Then, by using the Set knob,
previous alarms will be displayed in historical order.
The alarms which can be displayed are:
Ven Press High, Ven Press Low, Art Press High, Art Press Low, TMP
High, TMP Low, SN Stroke Low, Blood Flow Low, Temp High, Temp
Low, Cond Alarm, pH Alarm, Air Detector Alarm, Art Guard Alarm
and Blood leak Alarm.
The Fluid bypass button is used to manually bypass the dialysis fluid
from the filter. If the button is pressed when the dialysis fluid has the
desired temperature and conductivity the button will flash (even if
there is no alarm on the fluid side).
When the Fluid bypass button has flashed for 5 min. during treatment
an attention alarm appears, instructing the operator to press the button.
The Start UF Stop button is used to start and stop the controlled
ultrafiltration. The button flashes when the blood detector detects
blood.
The ultrafiltration will start when the flashing Start UF Stop button
is pressed.
NOTE
By pressing the Start/UF/Stop button during treatment the
ultrafiltration rate is reduced to the set minimum UF rate. The
permitted stop time can be preset between 1-10 minutes.
When this time has expired, an attention alarm will be given
instructing the operator to restart the ultrafiltration.

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Display and setting group


Information display
The information display is used for giving the operator further
information. The information display will only show information on
request. Press the appropriate button in order to get information.
The information display is automatically turned off after 15 seconds if
the Hold button is not activated.

Viewing Angle Adjustment


The viewing angle of the information display can be adjusted as
follows:
1.

Press any parameter button in order to get a display.

2.

Press the Hold button.

3.

Adjust the contrast with the Set knob .

4.

Press the Hold button or any parameter button.

It is also possible to adjust the viewing angle of the bargraph display.


The information display sign has to be extinguished.
Do as follows:
1.

Press the Select arrow button.

2.

Press the Hold button.

3.

Turn the Set knob to adjust the viewing angle.

4.

Press the Hold button or any parameter button.

The Hold button is used to hold the information on the information


display. The hold function disappears as soon as the Hold button or
any other parameter is pressed.
The Select arrow button is used to select the valid parameter for
adjusting a set value or an alarm limit. When the button is pressed the
parameter flashes and the set value or alarm limit can be adjusted by
turning the Set knob. The button is also used for confirming various
messages on the information display.
Four parameters (blood flow, venous pressure, TMP and accumulated
UF volume) may be displayed by pressing the Select arrow button
when the information display is extinguished. Pressing the Select
arrow button once more will display the dialysis fluid flow, and if it
is pressed again the display toggles back showing the four parameters
(blood flow, venous pressure, TMP and accumulated UF volume).

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The Set knob is used for setting of all parameters, except for the blood
flow.

The Blood flow knob is used to set the blood flow. The Blood flow knob
is directly accessible, i.e. without first having to press the Blood Flow
button. The information display lights up when the knob is turned.

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The eight commandments


1. When a blue button is lit, it indicates an activated function.

2. When a red button is lit, it indicates an alarm.

3. When a button flashes, it is a request to press it.

PASSE
0:00

4. The information display only shows information on request.

5. To request information in the display, the appropriate button has to


be pressed.

6. Changeable values on the information display can be selected with


the Select arrow button. The selected value flashes.
7. The flashing value can then be changed with the Set knob .

8. The blood flow rate may always be changed directly with the Blood
flow knob.
The handling concept for the operator is based completely on the eight
commandments above.

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Setting of parameters
All treatment parameters are set in a similar way.

When pressing a treatment parameter button, the current parameter


values will be illuminated on the information display.

When pressing the Select arrow button one of the parameters


flashes and may be changed.

By pressing the Select arrow button again another parameter on the


display may be adjusted.

For parameters that have one low and one high limit, both limits
can be changed simultaneously by pressing the Select arrow button
once again.

When pressing an alarm parameter button, the actual alarm limit


will be the first parameter to flash on the information display.

To illustrate this, a detailed description follows showing how the values


for the dialysis fluid temperature are changed.
The bargraph display shows:
033

35

37

39

50

100

40

Temp

Press the Temp button. The information display will show:

Press the Select arrow button once or repeatedly to choose set value,
low, high or both alarm limits. If the purpose is to move the alarm
window, both low and high limits must flash.
The adjustable parameter(s) text and the corresponding scale(s) on
the bargraph display will flash.
Turn the Set knob and change the set value or alarm limits. A change is
made both on the information and bargraph displays.
The light of the information display goes out and the bargraphs turn
into a constant light 15 seconds after the Set knob was touched.
However, it is possible to select new information on the information
display by pressing another button before the 15 seconds have passed.
If the temperature needs to be studied in digital form for more than 15
seconds, press the Hold button. The Set knob is then disconnected.
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Pressing the Select arrow button will make a parameter changeable


again and leave the hold position.
It is always possible to leave the hold position by pressing the lit Hold
button or another button.
NOTE
In the interest of safety, the set values, alarm limits and other
changeable values can only be set within preset ranges.

The following parameters can be set:


Chemical disinfection
Three different chemical disinfection programs can be selected with
the Select arrow button.

Heat disinfection
A heat disinfection program alone or in combination with citric acid or
with CleanCart can be selected with the Select arrow button.

Rinse/Drain
The rinse time can be changed by the Set knob .

Acetate
Three types of acetate concentrates can be selected with the Select
arrow button.

Bicarbonate
Three combinations of acid and bicarbonate concentrates can be
selected with the Select arrow button.

Venous pressure
The low and high alarm limits can be changed with the Set knob either
together or separately or by the centralizing function.

Blood flow
The Blood flow knob is directly accessible i.e. without first having to
press the parameter button.

Single needle data


The low alarm limit for the stroke volume and the opening times for
the venous and the arterial clamps may be changed with the Set knob.

Temperature
The set value, the low and high alarm limits for the temperature may
be changed with the Set knob. The alarm limits can be changed either
together or separately.
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Conductivity
In acetate mode, the set value for sodium may be changed with the Set
knob. In bicarbonate mode, the set values for sodium and bicarbonate
may be changed. The conductivity alarm limits are automatically
calculated to the set value 5 %. Both high and low limits for Na+ and
HCO3- in Acetate (only Na+) and bicarbonate modes can be preset.

Arterial pressure
The low and high alarm limits can be changed with the Set knob either
together or separately or by the centralizing function.

TMP
The low and high alarm limits for the transmembrane pressure can
be changed with the Set knob either together or separately or by the
centralizing function.

UF volume
The set value for the ultrafiltration volume during diffusion may be
changed with the Set knob.

UF rate
The priming UF rate and minimum UF rate in treatment/priming may
be changed with the Set knob.
NOTE
If the calculated UF rate is lower than the set minimum UF rate,
the machine will not go below this set minimum UF rate. An
attention alarm will be given.

Time
The remaining treatment time may be changed with the Set knob.

Heparin
The set value for the heparin flow rate and the stop time for the
heparinization (time before treatment stop) may be changed with the
Set knob. If the blood pump is stopped the heparin pump will continue
to run if it is not stopped manually.

BPM (option)
It is possible to set modes and alarm limits for the BPM (Blood Pressure
Monitor) function. See Modes and/or Alarms in chapter 6.

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HCEN9794 Revision.08.2003
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Setting of the pressure alarm limits


The machine is equipped with a centralizing function to simplify a
correct setting of the alarm limits for the venous pressure, the arterial
pressure and the TMP. When the alarm limits are outside the preset
range, the Venous pressure , the Arterial pressure and the TMP buttons
will flash. When the buttons are pressed the alarm limits will centralize
around the current pressures with the preset range.
An attention alarm is activated if the alarm limits are still outside the
preset range when 2 minutes of the treatment time have elapsed. Press
the Attention alarm button and the text on the information display will
show which pressure limits to correct.
The machine is equipped with a function to avoid unnecessary venous
pressure alarms. When the blood flow rate is changed, the alarm
windows for the venous pressure, the arterial pressure and the TMP are
widened automatically and the corresponding buttons start to flash.
Set the limits as described above.
In certain treatment situations, for example in the case of low venous
pressure alarm, it can be useful to widen the alarm window temporarily.
Press the Venous pressure button and adjust the specific alarm limit.
When the alarm window is widened in this way outside the preset
range, the Venous pressure button will start to flash. Set the limits
as described above.
The Arterial pressure and the TMP alarm windows may also be
handled in an analogous way.

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The ultrafiltration control


During treatment the following equation is always applicable:

Ultrafiltration volume
UF rate
Treatment time
Treatment time and UF volume may be set within certain limits. The
machine will automatically calculate and show the UF rate. When
treatment time or UF volume is changed the UF rate will also change.
An example of how a UF setting is done is shown below:
1. Press the Time button and select the treatment time.
2. Press the UF volume button and select set UF volume. (As soon as
the Select arrow button is pressed, the bar on the UF rate display
also starts to flash, showing the calculated UF rate).
3. When the flashing Start UF Stop button has been pressed (light
on), the TMP alarm limits must be centralized. Note that the alarm
limits should be set in accordance with the UF rate and filter UF
coefficient.
NOTE
When negative TMP alarm limits are set, an attention 2 will
indicate that no backfiltration warning will occur. This attention
has to be confirmed.

An attention alarm may appear if an incorrect combination of settings


is made, e.g. the time is set to 0.00 and the UF volume is set. The
alarm will disappear as soon as the time is sufficiently increased.
A high UF rate limit is automatically calculated and set as 120 % of the
calculated UF rate. This limit is the highest UF rate during treatment.
If, for any reason, the UF rate has been too low during a period of
time, the machine will try to compensate for this by increasing the UF
rate, but within the UF rate limits.

3:28

Can be preset
AK 95 S Operators manual - Controlling the machine

HCEN9794 Revision.08.2003
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Recovery from power failure


In case of a short power failure the settings and accumulated values
are stored by the machine. The machine will perform a recovery when
the power returns, if the machine has passed the function test and time
has appeared on the display. Otherwise the machine will perform a
restart, with a new function test.
During a power failure when the machine is working, a segment on the
TIME display is flashing.

An attention will appear and the buzzer sounds. The text reC is
shown on the time display. The operator must confirm the restart by
pressing the flashing Time button. The machine will then continue the
treatment from where it was interrupted.
The machine can also be preset to run only with the blood pump after a
power failure. In this case another attention alarm will be displayed:

When the Select arrow button is pressed, the fluid monitor will start.
CAUTION
Check treatment parameters after a recovery.

NOTE
If the attention

has been confirmed, the AK 95 S will not restart automatically.


There will be no sound from the buzzer and no flashing
segment on the TIME display during power failure. The On/Off
button has to be pressed to recover function.

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Returning the blood during a power failure


It is possible to manually return the blood to the patient during a power
failure.
1. Clamp the arterial blood line and disconnect it from the patient.
2. Connect the arterial blood line to the rinse-back solution and
unclamp it.
3. Open the cover of the blood pump and turn the blood pump
manually in the direction indicated by the arrows.
4. When the required amount of blood has been returned to the
patient, clamp the venous blood line and disconnect it from the
patient.
WARNING
During manual procedure to return blood to patient in power
failure, the operator assumes responsibility for visually
monitoring all safety parameters which the machine cannot
monitor in a power failure (e.g. air detection).

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Change of blood pump segments


The AK 95 S can be used with three diameters of blood pump segments
which can be preset.
This means that the correct blood flow values are displayed and there is
no need for recalculations when one of the preset diameters is chosen.
NOTE
The AK 95 S must be in priming phase and the blood pump has
to be stopped in order to change the diameter of the blood
pump segment.
It will be necessary to adjust the blood pump head occlusion.

1. Press the Blood flow button.


2. Press the Select arrow button twice.
3. Use the Set knob to select the appropriate blood pump segment
diameter.
Following attention is displayed:

4. Adjust the blood pump head occlusion.


5. Press the Blood flow button.

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Chapter 4
Treatment operations
Initial procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
First check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Start the machine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
For acetate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
For bicarbonate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Attaching the filter and the blood lines . . . . . . . . . . . . . . . . . . . . . . . .
Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Arterial blood line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Venous blood line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Dialysis fluid tubes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Priming and rinsing the extracorporeal circuit . . . . . . . . . . . . . . . . . . .
Before priming . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
High venous pressure test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Initiating dialysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Setting of treatment parameters . . . . . . . . . . . . . . . . . . . . . . . . . . .
Connect the patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Start of ultrafiltration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Set the alarm limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
BPM (option) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
High arterial pressure alarm limit setting . . . . . . . . . . . . . . . . . . . .
Minimize the risk of generating microbubbles . . . . . . . . . . . . . .
Single needle treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Isolated UF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Discontinuing dialysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Returning the blood . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Emptying and disconnecting the filter . . . . . . . . . . . . . . . . . . . . . .

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4:1

Initial procedures
NOTE
In the machine has been stored with a chemical disinfectant,
this solution must be rinsed out of the system before any
treatment can be initiated.

First check

That the mains cable is connected to a mains supply with protective


earth.

That the main switch on the rear of the monitor is turned on.

That the interface cable, if included, is connected to the monitor.

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 the dialysis fluid tubings are connected to the safety couplings.
CAUTION
In order to protect the operators fingers, keep the blood pump
and the clamp covers shut during the function check for the
blood unit since the pump as well as the clamps will be tested
during the check.

NOTE
1. When the machine starts it always carries out an internal safety
check. This check requires that the dialysis fluid tubes are
connected to the safety couplings. The dialysis fluid tubes
must remain connected to the safety couplings until FCh has
disappeared from the time display.
2. When the machine is connected to power and the main switch
is in ON position, a lit segment is shown on the TIME display.

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Start the machine


The filter and the blood lines may be attached before power on or when
the Priming button has been lit. Follow the instructions in this chapter
Attaching the filter and the blood lines.
1. Press the ON/OFF button for 3 seconds.
The machine will carry out a function check - FCh is shown on the
time display.
All the buttons and bargraphs on the operators panel are illuminated
simultaneously and the operator is requested to check their functionality
by visual inspection.
If the Attention alarm button or the Technical alarm button are
illuminated, press the appropriate button for information.
If the machine has been disinfected, press either the Rinse/Drain or
the Reset button. This will set all accumulated values to zero and all
parameters into preset values. In addition an internal function check is
performed, indicated by the FCh on the time display.
If the machine is on and another treatment is to be performed, press
the Reset button for 3 seconds. This will set all accumulated values to
zero and all parameters to their preset values.
An information text will be displayed:

NOTE
In order to finalize the function check, the A-concentrate/acetate
must be connected and the venous drip chamber filled to the
correct level. The reason is, that the conductivity cells must be
checked with conductivity and the air detector must be checked
with fluid in the chamber. When the function check is finished,
the treatment time appears on the time display.

2. Check that the correct mode and concentrate(s) are used. (The
start-up mode may be preset.)
NOTE
During the conductivity test in function check it is not possible
to change between Bicarbonate and Acetate mode. If the
conductivity check during function check was performed in
Acetate mode it is not possible to switch to Bicarbonate mode
during treatment. However, it is always possible to change from
Bicarbonate to Acetate mode during treatment.

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For acetate
a.

Press the Acetate button. Check that the correct concentrate


is selected. The number to the left on the information display
indicates which concentrate is selected. For instance if the number
to the left says 2 the middle concentrate should be flashing.

b.

Press the Cond button to set the sodium value. The start-up
sodium value can be preset.

c.

Place the concentrate pick-up tubes in correct positions: the


B pick-up tube in the acetate concentrate container and the A
pick-up connector tube in the coupling of the mixing unit.

For bicarbonate
a.

Press the Bicarbonate button. Check that the correct concentrate


is selected. The number to the left on the information display
indicates which concentrate is selected. For instance if the number
to the left says 2 the middle concentrate should be flashing.

b.

Press the Cond button to set the sodium and bicarbonate value.
The start-up sodium and/or bicarbonate value can be preset.

c.

Place the concentrate pick-up tubes in correct positions: The A


pick-up tube in the acid concentrate container and the B pick-up
tube in the bicarbonate concentrate container. If the BiCart
column is to be used, place the B pick-up tube connector in the
coupling of the mixing unit.

Attach the BiCart column. Refer to the specifications and instructions


for the BiCart column. The BiCart will be primed automatically when
the latches are attached to the BiCart.
CAUTION
Verify that the prescribed concentrate(s) for the specific
treatment is (are) used. Avoid changing concentrate containers
during treatments.

NOTE
Fixed conductivity alarm limits (5 %) will be set automatically,
centred around the conductivity set value as shown on the
bargraph.

3. Check all the set values and the alarm limits. Adjust if necessary.
CAUTION
Before preparing the machine for treatment, check that the
mode and the set values are correct.

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Attaching the filter and the blood lines


When the Priming button has been lit, the filter and the blood lines
may be attached, if this has not been done before power on.
WARNING
The operator must take proper precaution in order to prevent
coagulation in the extracorporeal circuit.
Coagulation may lead to:
inadequate delivery of dialysis

risks associated with propagation of blood clots to the patient


disabling of the air detector function if blood clots aggregate in
the drip chamber.

CAUTION
To avoid safety hazards, when attaching the blood lines to the
machine it is important to:
follow the instructions given in the package inserts for the
blood lines

ensure that connections are secured tightly


check that no part of the blood lines are kinked

NOTE
Since tests of the blood pump and the clamps are included
in the function check, it is important that the blood lines are
attached either before power on or when the Priming button
has been lit.
If the blood lines have been attached and primed before
the function check has been initiated, the venous pressure
transducer protector must not be connected until the function
check for the blood unit is completed.

Filter
Set up the filter according to the instructions for the specific filter.
Place the filter in the holder.

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Arterial blood line


1. Arterial line guide
Place the line in the guide.
2. Arterial pressure transducer connector
Attach the transducer protector firmly to the pressure transducer
connector.
3. Blood pump
Open the cover and place the pump segment inside the pump
housing. Turn the blood pump manually in the direction of the
arrow to thread the pump segment. When the pump segment is
in place, close the cover.
CAUTION
The pump segment connectors must be outside the pump
housing.

4. Filter connection
Attach the connector to the blood port on the top of the filter.
5. Arterial line clamp
Place the patient -end of the arterial line into the line clamp colour
-coded with the red dot.
6. Heparin pump
WARNING
The operator must take proper precaution in order to prevent
coagulation in the extracorporeal circuit.
Coagulation may lead to:
inadequate delivery of dialysis

risks associated with propagation of blood clots to the patient


disabling of the air detector function if blood clots aggregate in
the drip chamber.

NOTE
Make sure that the heparin pump is adjusted for the syringe
size that is being used.

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3
2
1
6

1009

4
5

Figure 4:3

HCEN9794 Revision.08.2003
Program version 10.xx

Arterial blood line, set-up

AK 95 S Operators manual - Treatment operations

4:7

If heparinization is desired by using the heparin pump the preparations


are made in the two following steps:
6.1 Attach the syringe to the heparin pump:
Prepare a syringe with the desired amount of heparin solution (or
other anticoagulantia).
Attach the syringe to the heparin line on the arterial blood line.
Prime the heparin line with the solution to the point where the heparin
line ends in the arterial blood line.
Pull out the piston on the heparin pump to end position.

Figure 4:4

Change position of the heparin pump holder

To change the position of the piston, press the end of the piston, hold it
in and move the holder. When the piston is released the holder cannot
move.
Insert the syringe in the pump; the plastic collar at the end of the
syringe must fit in the groove of the pump.
Push back the piston and insert the plastic plate on the plunger in
the groove by the locking wheel.
Turn the locking wheel upwards until resistance is felt. This is to lock
the plastic plate of the plunger in the groove.
Check that the syringe is properly secured by lightly pulling the
plunger out of the pump.

Pulling
direction
Figure 4:5

EN1068

Locking
direction

Syringe attached to the heparin pump

6.2 Set the heparin values in the machine:


Press the Heparin button briefly
Select the heparin flow rate (ml/h)
Check/adjust the STOP TIME in minutes i.e. at which time the
heparinization should stop before treatment ends.
As soon as the treatment starts (priming detector detects blood)
the heparinization starts (the Heparin button lights up). To start
heparinization during priming, press the Heparin button for 3 seconds.
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If the set value is 0 when the priming detector detects blood, the
Heparin button starts to flash and an attention is given.
CAUTION
To prevent the syringe from loosening from the heparin pump
during treatment the syringe plunger has to be thoroughly
secured. Check by lightly pulling the plunger out of the pump.
When doing so, it must be impossible to pull the syringe out of
the heparin pump.

HCEN9794 Revision.08.2003
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AK 95 S Operators manual - Treatment operations

4:9

Venous blood line


1. Air detector
Place the venous drip chamber in the air detector so that the
indicator line on the drip chamber is in level with the top of the air
detector head. Close the air detector cover.
2. Priming detector
Place the venous line in the priming detector.
CAUTION
Check carefully that the venous blood line is correctly placed
in the priming detector.

3. Venous line clamp


Place the patient end of the venous line into the line clamp
colour-coded with the blue dot.
4. Venous pressure transducer connector
Attach the transducer protector firmly to the pressure transducer
connector.
5. Filter connection
Attach the connector to the blood port at the bottom of the filter.

Dialysis fluid tubes


When FCh has disappeared from the time display, disconnect the
dialysis fluid tubes from the safety couplings and attach them to the
filter.

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Program version 10.xx

4
1
2
3

1010

Figure 4:6

HCEN9794 Revision.08.2003
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Venous blood line, set-up

AK 95 S Operators manual - Treatment operations

4:11

Priming and rinsing the extracorporeal


circuit
Before priming

Connect the arterial line to the priming fluid.

Check that the venous line is correctly positioned in the priming


detector.

Check all connections.

Check that the priming UF rate is correct (follow the instruction for
use of the filter).

If heparin is not to be used during priming, check that the Heparin


button light is off.

It is possible to prime the blood compartment of the filter and the blood
lines during disinfection or during the function check when the Priming
button has been lit. If priming has been done during disinfection the
venous pressure transducer protector must not be connected until the
function check for the blood unit is completed.
1. Check that the Priming button is lit.
2. Press the flashing Blood pump button. The blood flow rate will
automatically start at 100 ml/min. Adjust the blood flow. Prime
and de-air the blood lines and the filter.
3. Follow the instructions for the use of the filter and the blood lines.
4. Adjust the level in the drip chamber, so the level is well above the
air detector head.
5. When the level in the air detector is correct, the Air detect button
will start flashing and an attention without buzzer regarding the
inactivated air detector will appear. The attention will remain until
the air detector is activated (manually when desired/automatically
when blood is detected).
6. When the priming volume 1 has been achieved, the blood pump
automatically stops and the attention:

appears. If it does not automatically stops, press the illuminated


Blood pump button. The blood pump stops and the button starts
to flash.

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HCEN9794 Revision.08.2003
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CAUTION
1. The operator must check that the blood pump stops when the
upper venous pressure limit is reached.
2. The operator must check the functionality of the arterial
pressure transducer by clamping the arterial line before the
arterial pressure transducer and check that the changes in the
arterial pressure are shown on the bargraph display.

7. Activate the dialysis fluid, if this is not done yet, by pressing the
flashing Fluid bypass button, the button will light up.
The time display lights up when the conductivity test is finished,
the dialysis fluid has the correct temperature, the venous drip
chamber is filled with fluid to the correct level and the air detector
test is finished.

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AK 95 S Operators manual - Treatment operations

4:13

High venous pressure test


A high venous pressure test is performed when the following conditions
has been fulfilled

the air detector has been tested and there are no alarms from it

the dialysis fluid tubes are placed on the filter

the dialysis fluid has entered the filter (i.e. when both
compartments of the filter have been filled with fluid).

When this is accomplished an attention appears:

1. Press the Venous pressure button.


The AK 95 S will now close the venous clamp and run the blood
pump until a venous pressure of 200 mmHg is achieved.
After half a minute an information text appears

and the test is finished

2. a. Continue to Initiating dialysis in this chapter.


If the conditions mentioned above are no longer fulfilled there
will be another attention:

2. b. Press the Select arrow button and correct according to the three
conditions mentioned above.
If no correction is made at this point or if the high venous pressure
test is not initiated by the operator when the first attention appears,
the attention concerning the high venous pressure test will
disappear when the priming detector detects blood.

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Initiating dialysis
Setting of treatment parameters
CAUTION
To avoid hazardous side effects during the treatment, the
parameters and the alarm limits shall be suitable for the
patients needs and tolerance.

1. Set the UF volume to the required total ultrafiltration volume.


2. Set the treatment time.
3. Check that the calculated UF rate is not too high, adjust treatment
time or UF volume if necessary. The high limit for UF rate can
be preset.
4. Verify that the dialysis fluid has the desired temperature and
conductivity. The low limits for Na+ and bicarbonate can be preset.
5. Check/adjust the required blood flow rate.
6. Press the Heparin button and set the heparin dose (ml/h) and stop
time (the time in minutes at which the heparinization should stop
before the treatment ends).
CAUTION
1. Once the treatment parameters are set, the user should
verify that the control and protective systems (See Safety
philosophy) operate with the desired values and that they
are in agreement. This verification is made by comparing the
bargraph displays and the information display.
2. Make sure that the proper dialysis fluid is being used. Verify
by checking that the correct concentrate (in acetate mode) or
concentrates (in bicarbonate mode) are used.

Connect the patient


1. Check that there is no air in the blood lines and that the level in
the venous drip chamber is well above the air detector head. The
expansion chambers are filled to the correct levels (refer to the
instruction for use of the individual blood line).
2. Activate the air detector by pressing the Air detector button.
NOTE
If the air detector is not activated manually by pressing the
Air detector button, it will automatically be activated when the
priming detector detects blood.

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4:15

3. Connect the blood lines to the patient.


NOTE
The blood pump can automatically be stopped when the
priming detector detects blood in the venous line and the blood
path in the flow diagram lights up 2.
The function check has to be completed and the time display
has to be lit.
The operator should bare in mind that the air detector still is
in need of supervision while the machine is in priming mode
unless it is activated manually.

4. Remove any obstructing clamps.


5. Start the blood pump and increase the blood flow to the desired
blood flow rate. When the priming detector detects blood in the
venous line, the blood path in the flow diagram lights up red, the
treatment time starts, the Heparin button lights up and the Venous
pressure , the Arterial pressure , the TMP and the Start/UF/Stop
buttons start to flash.
CAUTION
Make sure that the blood path of the flow diagram lights up, if it
does not light up, check that the venous blood line is correctly
placed in the priming detector. If the blood path does not light
up, the machine considers the patient not connected and as
a consequence the UF system is not controlling the patient
ultrafiltration. If the air detector has not been activated during
priming it will not be automatically activated until the priming
detector detects blood.

The machine will remain in blood state until the treatment time =
0:00 and end of treatment is confirmed, even if the venous line is
removed from the priming detector.
In the case where one treatment is completed, and another is started
without a reset being made, the following attention alarm will appear:

If the Select arrow button is pressed the accumulated values will not be
reset. Press the Reset button to reset the accumulated values.

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HCEN9794 Revision.08.2003
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NOTE
No reset can be made if the blood pump has been started
and/or the Start/UF/Stop button has been pressed. In this case
the blood pump must be stopped and/or the Start/UF/Stop
button must be pressed again in order to make a reset.

Start of ultrafiltration
Press the Start/UF/Stop button (lights up) to start ultrafiltration.
If the Start/UF/Stop button is not pressed within 5 minutes after the
priming detector is activated, an attention alarm will appear.
NOTE
If the patient's blood pressure drops during treatment it is
advisable to press the Start/UF/Stop button. The ultrafiltration
rate will immediately decrease to a minimum, but with the
treatment time still counting down. There will be an attention
alarm after 5 minutes asking the operator to restart the
ultrafiltration. If it is desired to continue the volume control
or the isolated UF with the same parameters, press the
Start/UF/Stop button. The ultrafiltration rate will slowly increase
to the set value.

Set the alarm limits


When the Venous pressure , the Arterial pressure and the TMP buttons
flash, press the buttons to set the alarm limits around the current
pressures. If needed, adjust the limits (the alarm windows can be
preset).
Note that the TMP alarm limits should be set in accordance with the
UF rate and the filter UF coefficient.
NOTE
When negative TMP alarm limits are set, an attention 3 will
indicate that no backfiltration warning will occur. This attention
has to be confirmed.

Certain actions from the operator result in venous pressure, arterial


pressure or TMP changes. In order to avoid alarms, the alarm windows
will automatically open to the settings used in priming (the buttons
start to flash).
Press the flashing button to set the alarm limits around the new
pressure. An audible attention alarm will be issued after 2 minutes
(repetition interval 2 minutes), if a new centralization of the limits
have not been done.

3
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4:17

The actions mentioned above which automatically open up the alarm


windows are for venous pressure:
Changing the blood flow
Pressing the Blood pump button
for arterial pressure:
Changing the blood flow
Pressing the Blood pump button
for TMP:
Pressing the Start/UF/Stop button
Pressing the Blood pump button
CAUTION
The correct setting of the UF rate is important to avoid
backfiltration. Set a minimum UF rate according to the
instruction for the specific filter.

BPM (option)
If the BPM (Blood Pressure Monitor) function is to be used, set modes
and alarm limits according to instructions in chapter 6.

High arterial pressure alarm limit setting


Sometimes during treatment it is essential to give the patient saline
infusion before the blood pump. When doing this the arterial upper
alarm limit set by the centralizing function can be disturbing. Upon
request from the clinic it is possible to adjust the upper alarm limit.
However, the following conditions have to be fulfilled.

The function has to be ordered by the physician

The machine has to be identified/labelled

The preset has to be documented in the machine logbook

CAUTION
If the upper arterial alarm limit is adjusted by preset, the
following alarm situations may not be detected during treatment:
a disconnection of the arterial line

a change of position of the arterial needle


if air enters the arterial line between the arterial access and
the blood pump
Special attention from the operator is therefore mandatory.

NOTE
Negative pressure may cause generation of microbubbles.

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HCEN9794 Revision.08.2003
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Minimize the risk of generating microbubbles


Follow the instructions below to minimize the risk of generating
microbubbles:

HCEN9794 Revision.08.2003
Program version 10.xx

Check the levels in the drip chambers during the treatment to


ensure that the levels are not decreasing over time.

Make sure that all connections in the extracorporeal circuit are tight.

Ensure that the blood flow rates are compatible with needle/catheter
lumen size and blood access/blood flow characteristics.

Carefully monitor the level and delivery rates of extra infusions


being administered.

AK 95 S Operators manual - Treatment operations

4:19

Single needle treatment


NOTE
1. It is recommended to use a blood line with an expansion
chamber. It is also recommended to place the expansion
chamber between the venous end of the filter and the venous
drip chamber.
2. When performing single needle treatment there is always a
certain amount of recirculation.
The AK 95 S is equipped with a clamp on the arterial side in
order minimize the recirculation.
To further minimize the recirculation the stroke volume should
be maximized. To achieve this the following should be
considered:
Make sure a correct blood pump rotor is used. There must
be a correct adjustment of the occlusion of the blood pump
segment being used. Check with the service technician
responsible.

The volume of the expansion chamber should be as big as


possible.

The internal diameter of the needle should be as big as

1011

possible.

Figure 4:9

Venous blood line with expansion chamber

Follow the instructions in this chapter until the section Initiating


dialysis - Connect the patient.
1. Set the arterial and venous phase times. Press the SN data button
and check/adjust the opening times for the venous and arterial

4:20

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HCEN9794 Revision.08.2003
Program version 10.xx

clamps. Settings can be made between 2-20 seconds. If the venous


pressure alarm limits are required as limits for the SN treatment,
adjust the low and high limits to desired values.

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AK 95 S Operators manual - Treatment operations

4:21

2. Check that there is no air in the blood lines and that the venous
drip chamber is well above the air detector head. The expansion
chambers are filled to the correct levels (refer to the instruction for
use of the individual blood line).
3. Activate the air detector by pressing the Air detector button.
NOTE
If the air detector is not activated manually by pressing the
Air detector button, it will automatically be activated when the
priming detector detects blood.

4. Connect the blood lines to the patient.


NOTE
The blood pump can be automatically stopped when the
priming detector detects blood in the venous line and the
blood path in the flow diagram lights up4. The function check
has to be completed and the time display has to be lit. The
operator should bare in mind that the air detector is still in need
of supervision while the machine is in priming mode unless it
is activated manually.

5. Press the SN button for 3 seconds, it lights up.


6. Remove any obstructing clamps.
7. Start the blood pump
8. Press the flashing Venous pressure button to set the SN limits.
9. Press the Start/UF/Stop button.
10. When the pressures have stabilized, set the arterial pressure and
the TMP alarm limits.
NOTE
1. When negative TMP alarm limits are set, an attention4 will
indicate that no backfiltration warning will occur. This attention
has to be confirmed.
2. If switching from double needle to single needle during
treatment:
Connect an expansion chamber to the extra corporeal circuit
Set new venous pressure alarm limits

4:22

Can be preset
AK 95 S Operators manual - Treatment operations

HCEN9794 Revision.08.2003
Program version 10.xx

Isolated UF
Follow the instructions in this chapter up to Connect the patient.
Isolated ultrafiltration can be performed before, during or after the
normal dialysis treatment.
1. Press the Isol UF button
Set the required treatment time for the Isol UF phase.
Set the required UF volume for the Isol UF phase
There are two different alternatives to preset the machine, concerning
time and UF volume.
The time and UF volume set for the Isol UF phase will be added
to the time and UF volume set for the diffusion phase. This
means that the total treatment time and UF volume will increase.
The time and UF volume set for the Isol UF phase will decrease
the treatment time and UF volume set for the diffusion phase.
This means that the total treatment time and UF volume will
not be changed.
2. Press the Isol UF button for 3 seconds, the button illuminates.
3. Check that the calculated UF rate is not too high, adjust treatment
time or UF volume if necessary.
4. Continue to Connect the patient in this chapter
When the time for the isolated ultrafiltration phase is finished, the
machine will automatically switch to diffusion.
Adjust the TMP alarm limits when the TMP has stabilized.
NOTE
1. The time in isolated ultrafiltration mode is included in the
passed treatment time and also in the treatment without
diffusion (non-diffusion time). The UF volume achieved in
isolated ultrafiltration mode is included in the total accumulated
UF volume.
2. If heparinization is desired during the entire UF phase, set the
heparin stop time to 0:00. Check/adjust the heparin stop time
when the machine has switched to diffusion.

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AK 95 S Operators manual - Treatment operations

4:23

Discontinuing dialysis
When the remaining treatment time reaches 0:00, the following occur:

The ultrafiltration rate decreases to minimum UF.

The TMP alarm limits are widened.

The light of the Start/UF/Stop button goes out.

The Time button flashes and an attention alarm (supersoft) appears.

To finish the treatment, press the flashing Time button for 3 seconds.
NOTE
1. If the treatment is to be continued press the flashing Time
button briefly and set a new treatment time. The alarm will
then be cleared and it is possible to increase the UF volume,
or mini UF rate set to zero.
2. If the treatment time is turned down to 0:00 and there is still
time left under isolated UF an attention will appear. If the
treatment is to be finished without performing the isolated UF,
press the Isol UF button and turn down the time to 0:00.

It is not possible to finish the treatment properly unless the remaining


treatment time is 0:00 or below.

Returning the blood


1. Stop the blood pump. This will automatically widen the venous
pressure, the arterial pressure and the TMP alarm limits to their
priming values without subsequent centralizing alarm.
2. Clamp the arterial blood line and disconnect it from the patient.
3. Connect the arterial blood line to the rinse-back solution and
unclamp it.
4. Set the required rinse-back rate. Restart the blood pump.
NOTE
After having started the blood pump again, the operator is
responsible for the monitoring of the venous pressure.

5. Clamp the venous blood line repeatedly to facilitate adequate


emptying of the filter.
6. Stop the blood pump and clamp the venous line when the required
amount of blood has been returned to the patient.

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When the priming detector does not detect blood any more, the red
light of the flow diagram goes out, the Priming button lights up and the
blood pump stops (the Blood pump button flashes).
If more rinse-back is required, press the flashing Blood pump button
to continue.
7. Disconnect the venous blood line from the patient.
CAUTION
The venous line must be disconnected from the patient before
emptying the fluid side of the filter, i.e. connecting one of the
fluid tubes to the safety coupling. Otherwise the negative
pressure created by the machine in order to empty the filter
may cause a blood flow from the blood compartment to the
fluid compartment of the filter.

Emptying and disconnecting the filter


Check that the patient is not connected to the machine in any way, and
that the blood pump is not running.
1. Remove the venous line from the priming detector and check that
the light in the blood part of the flow diagram is extinguished (
Priming button: light on).
2. Set the dialysis fluid in bypass (press the Bypass button)
3. Invert the filter, disconnect the inflow dialysis fluid tube (from the
machine to the filter) and place it in one of the safety couplings.
4. Once the inflow dialysis fluid tube connector is placed on the
machine, the machine will create a negative pressure that empties
the dialysis fluid compartment of the filter. When the filter is
empty, place the outflow dialysis fluid tube (from the filter to the
machine) in the safety coupling.
5. Remove the concentrate pick-up tube(s) from the concentrate
container(s) and attach the connector(s) to the coupling(s) on the
mixing unit.
6. When BiCart has been used, press the Bicarbonate button twice
and an attention appears. Confirm the start of the fluid/fluid and
powder 5 emptying of the BiCart by pressing the Select button.
7. When the emptying is completed an attention appears. Remove the
column and close the latches.
8. Press any Disinfection/Rinse button for 3 seconds.
9. Remove the filter and the blood lines from the monitor. To turn
the machine off; press the ON/OFF button. The disinfection/rinse
program will continue until finished.
5
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AK 95 S Operators manual - Treatment operations

4:25

NOTE
If combined heat and CleanCart is selected, the conductivity
value must be below 2 mS/cm before the CleanCart is attached.

CAUTION
If the venous pressure transducer protector or the arterial
pressure transducer protector show signs of damage, i.e.
blood is appearing on the transducer side of the protector, it is
necessary to call for a service technician who must replace the
tubing set and the disk filter inside the machine.

NOTE
The machine must not be switched off without at least being
rinsed.

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Program version 10.xx

Chapter 5
Auto priming, Rinse-back
Auto priming (Option) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
General description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Filling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Pressure test (Option) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Priming . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Flushing part one . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Flushing part two . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Venous drip chamber level adjustment (Option) . . . . . . . . . . . . . . .
Filling of venous line (Option) . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Dialysis fluid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Operation of the autopriming . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Rinse-back . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
General description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Operation of the Rinse-back . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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AK 95 S Operators manual - Auto priming, Rinse-back

5:2
5:2
5:2
5:2
5:2
5:2
5:3
5:3
5:3
5:3
5:4
5:9
5:9
5:9

5:1

Auto priming (Option)


General description
Auto priming is a feature that enables the AK 95 S to automatically
prime, rinse and de-air the blood lines and the filter. It is also possible
to automatically make a leakage test of the filter and to make a venous
drip chamber level adjustment by using this feature.
The auto priming can be divided into seven phases. The phases can be
adjusted, included or excluded by preset(s). A phase can be excluded
by putting the corresponding preset(s) to 0. The auto priming function
consists of several presets, which are put in brackets ( ) in the text
below. Three different priming combinations can be preset.

Filling
The filling phase is the first phase in the auto priming procedure.
During this phase the blood compartment of the dialysis filter and the
blood lines are filled with priming solution. The filling time (Fill time:
0-60:00 min) and the filling flow rate (Fill flow: 0-500 ml/min) can
be preset. The priming UF rate (Priming UF Rate: 0-4.0 l/hour) must
be preset. If a heparin infusion is required during priming, this must
be preset (Heparin set flow: 0-10.0 ml/hour).

Pressure test (Option)


When the filling phase is finished the machine will continue with a
venous pressure test. This serves as a leakage test of the filter.
The test is performed by running the blood pump with the venous
clamp closed, which will build up a pressure in the blood lines and in
the filter. If the high pressure is not achieved within a specified time
or if the pressure falls too fast after having reached the high venous
pressure limit, there will be an attention.
The pressure building time (Pressure build time: 0-30 s), the pressure
drop time, (Pressure drop time : 0-1:00 min) and the acceptable
pressure drop (Pressure drop: 0-100 mmHg) are presettable.

Priming
The priming phase is the third phase of the auto priming procedure. In
this phase the air bubbles are removed from the filter by opening and
closing the venous clamp intermittently, while the blood pump runs.
The priming time (Priming time: 0-60:00 min), the priming flow rate
(Priming flow :0-500 ml/min) and the opening/closing times for the
clamps (Priming cycle time: 0-1:00 min) can be preset.

Flushing part one


The machine will continue with two flushing phases, part one and two.
During this first flushing phase the blood lines and the filter are rinsed
with priming solution. The flushing part one flow rate is the same as
for the priming phase. After a presettable time the blood pump stops
(Flushing time 1:0060:00 min). In addition to above, the dialysis fluid
will be automatically activated during this phase. Depending on the
status of the dialysis fluid and on two presets (FM active: Not Inst/Inst
and Early FM start: Not Inst/Inst) the dialysis fluid will be activated
and flushed through the dialysis filter.

5:2

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Flushing part two


To start the second part of the flushing, the Blood pump button must be
pressed. When doing so the machine continues with flushing part two.
This makes it possible to do a final flush just before the treatment is
started.
The flushing part two flow rate is the same as for the priming and the
flushing part one.
The time of the flushing part two (Flushing time 2:00-60:00 min) can
be preset.

Venous drip chamber level adjustment (Option)


When the flushing parts are finished the machine continues with the
venous chamber level adjustment.
In this phase, the fluid level in the venous drip chamber is automatically
adjusted, however this requires a special tube set. The set must include
an extension tube, which goes from the top of the venous drip chamber,
down through the arterial clamp. Normally the arterial clamp is closed,
but when the drip chamber level is to be adjusted, the arterial clamp
opens and the venous clamp closes. When the blood pump runs, the
fluid level in the drip chamber rises and the air in the drip chamber
is pushed out through the tube. When the drip chamber is filled to
the appropriate level, the arterial clamp closes again and the venous
clamp opens.
The time necessary to fill up the venous drip chamber to a correct level
(Level time: 0-1:00 min) is presettable.

Filling of venous line (Option)


This is the last step of the auto priming where the remaining air in the
venous blood line is flushed out. The time when the venous clamp is
open (Venous line time: 0:00-2:00 min) can be preset.

Dialysis fluid
The dialysis fluid can be preset to flush through the filter automatically
(FM active: Install/Not Install). It is also possible to preset when the
dialysis fluid should flush through the filter, before or after the blood
lines have been rinsed (Early start of FM: Install/Not Install).

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Operation of the autopriming


NOTE
Before starting the auto priming, it is essential that correct
settings of the preset parameters have been made and that
they correspond to the type of filter and the blood lines used.
Make sure that the total volume of priming solution is enough to
cover the preset flow rate and priming time.

The text below in italics is an example of how to use the auto priming
feature, using a Gambro Polyflux 11 S. Assume that 1.5 litres of
priming solution is to be used. This is only an example. The presets
must be set in accordance with the respective users needs.
In the following example the default preset data are used:
Filling:

Fill flow : 100 ml/min


Fill time: 3 min (180 seconds)

Filling will consist of 300 ml of total priming volume.


Pressure test:

Pressure test build time: 0


Pressure test drop time: 0
Pressure test drop: 0

This means that the pressure test is not activated as default.


Priming:

Priming flow: 200 ml/min


Priming time: 2 min (120 seconds)
Cycle time: 3 seconds

Priming will consist of 400 ml of total priming volume and the venous
clamp will have an opening/closing time of 3 seconds.
Priming UF rate:

UF rate: 1.0 l/h (1000 ml/h)

Heparin set flow:

Flow: 0

This means no heparin is used as default.


FM active:
Early start of FM:

FM active: Inst
Early start of FM:Not Inst

This means that the dialysis fluid will automatically enter the filter
when flushing part one starts (if the dialysis fluid is correct).
Flushing part one:

Flush flow: 200 ml/min(always same


as during priming)
Flush time: 2 min (120 seconds)

Flushing part one will consist of 400 ml of total priming volume.

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Flushing part two:

Flush flow: 200 ml/min(always same


as during priming)
Flush time: 2 min (120 seconds)

Flushing part two will consist of 400 ml of total priming volume.


Level time:

Level time: 0

This means inactivation of the venous drip chamber level adjustment


since we in this example do not use the extra tubing set C- 1055.
Venous line time:

Venous line time: 0

This means inactivation of the last venous line filling and flush.

1. Set up the blood lines and the filter on the monitor, follow the
instructions in chapter 4 "Treatment operations - Attaching
the filter and the blood lines". If a venous drip chamber level
adjustment is to be performed, use a special extension tube (auto
priming line C-1055), which is placed from the top of the venous
drip chamber into the arterial clamp and the arterial blood line is
placed outside the arterial clamp.
No special extension tube is used, since the drip chamber level
adjustment will be done manually. Therefore the arterial line is placed
inside the arterial clamp and the preset for the drip chamber level
adjustment are set to 0 (Level time:0).
2. Connect the arterial line to the container with priming solution.
Place the free end of the venous line in an empty container.
3. If the machine is turned off, turn it on by pressing the On/Off
button, add the concentrate(s), follow the instructions in
Treatment operations - Start the machine. Check that the mode
and the set values are correct.
The priming UF rate is: 0.6-1.5 l/h when a Gambro Polyflux 11 S filter
is used.
NOTE
The dialysis fluid has to flush from bottom to top of the filter to
ensure a proper deaeration.
Therefore the filter must be inverted in accordance with this
when the dialysis fluid enters the filter during flushing part one.

4. a. Wait until FCh has disappeared from the time display. Take the
dialysis fluid tubes from the safety couplings and place them on
the filter. The filter has to be flushed from bottom to top in order to
remove air from the dialysis fluid compartment. There are three
different alternatives to preset the flushing of the dialysis fluid.

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FM active - not install and Early start of FM - not install: the


operator must press the Fluid bypass button when the dialysis fluid
should enter the filter.
FM active - not install and Early start of FM - install: the operator
must press the Fluid bypass button before the blood pump and the
rinsing of the blood lines can start. If this is not done an attention that
says:

will be given.
FM active - install and Early start of FM - not install: the dialysis
fluid will automatically enter the filter during flushing part one.
b. If no dialysis fluid is required during the priming phase, the auto
priming function can be activated as soon as the Priming button lights
up.
5. Press the Auto Priming button briefly and choose the desired
alternative with the Select arrow button. Activate the auto priming
by pressing the Auto Priming button for 3 seconds. The Auto
Priming button lights up.
6. Check that the venous pressure high limit is set according to the
instructions for the specific filter (set to +200 mmHg for Gambro
fibres). If a heparin infusion is required during priming, this must
be preset.
7. Invert the filter (arterial end downwards).
8. Start the auto priming procedure by pressing the Blood pump
button. The procedure may be stopped and started at any time by
pressing the Blood pump button, which flashes when priming is
stopped. If a start of the auto priming procedure from the beginning
is required, press the Auto Priming button for 3 seconds to exit the
mode and press the same button, for 3 seconds, to start again.
Now the blood pump automatically starts to fill the blood lines and the
filter at a preset rate and for a preset time.
The fluid unit keeps the preset priming UF rate. Verify that all air has
been removed from the arterial blood line when the filling procedure is
completed.
The pressure test of the filter is performed by setting the preset
parameters concerning the pressure test. If they are set to 0, the
pressure test is cancelled. If the pressure test is selected, an information
text appears:

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The test starts by pressing the flashing Blood pump button. The venous
clamp closes, and at the selected venous high pressure limit the blood
pump stops. If a fault is detected there will be an attention

Change of the filter or correction of the connections should be done.


When the fault is corrected, press the Select arrow button to continue or
start the auto priming from the beginning by pressing the Auto Priming
button to exit the mode and press the same button, for 3 seconds, to
start again.
Preset set to Pressure build time: 0 ,Pressure drop time: 0 and
Pressure drop: 0 The reason for not using this, is that normally it is
the responsibility of the operator to accept or not accept the pressure
drop.
In the priming phase the venous clamp opens and closes intermittently,
in order to de-air the filter, with a continuous running blood pump at
the priming flow rate. Here it is important that the blood flow rate and
cycle time matches each other to achieve the desired venous pressure.
NOTE
The dialysis fluid has to flush from bottom to top of the filter to
ensure a proper deaeration.
Therefore the filter must be inverted in accordance with this
when the dialysis fluid enters the filter during flushing part one.

During Flushing part one the blood lines and the filter are rinsed
with priming solution. If the preset is set to FM active the dialysis
fluid will enter the filter at this time. If the fluid preparation is not
completed, the process stops and waits until it is completed. The blood
pump stops after a presettable time. The flushing part one flow rate
will be the same as for the Priming phase.
9. When it is time to do a final flush before connecting the patient,
press the flashing Blood pump button. There will also be an
attention alarm reminding of this. Now the flushing part two starts
and runs for a preset time. The flushing part two flow rate will be
the same as for the Priming phase.
If the AK 95 S is preset to do a venous drip chamber level adjustment,
the blood pump stops and the venous clamp closes. The arterial clamp
opens and the blood pump starts to fill up the venous drip chamber.
When it is filled to an appropriate level the arterial clamp closes again.
Preset set to Level time: 0. The reason for not using this is the
risk of contamination. A special line must be attached to the venous
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drip chamber and subsequently removed afterwards. It is also the


responsibility of the operator to ensure that the level is correct and
that the blood lines are free of air.
The last phase of the auto priming is the flushing of the venous line in
order to remove the remaining air. The time is presettable.
Preset set to Venous line time: 0". This has to do with the automatic
filling of the venous drip chamber and since that is not used, do not
use this preset either.
The blood pump stops, the venous clamp closes, the Auto Priming
button starts to flash and the light of the Blood pump button goes out.
10. If an automatic venous drip chamber level adjustment has been
done, an information text appears:

Disconnect the special line from the top of the venous drip
chamber. Connect either a cap or a syringe to the free end of the
drip chamber. Remove the special line from the arterial clamp.
Place the arterial blood line in the arterial clamp.
11. Press the flashing Auto Priming button until the light goes out.
12. Turn the filter back to its correct position, arterial end upwards.
13. The machine is ready for treatment. Follow the instructions in
chapter 4 Treatment operations- Initiating dialysis.

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Rinse-back
General description
Rinse-back is a feature which can be preset that is used when the
treatment is to be finished. It enables the AK 95 S to automatically
rinse the blood lines and the filter, while the venous clamp opens and
closes intermittently. This is to maximize the emptying of blood from
the blood lines and the filter.

Operation of the Rinse-back


When the treatment is finished and the treatment time is 0:00, press the
flashing Time button for 3 seconds.
1. Stop the blood pump.
2. Clamp the arterial blood line and disconnect it from the patient.
3. Connect the arterial line to the rinse-back solution and unclamp the
arterial blood line.
4. Press the Rinse-back button for 3 seconds. The button lights up.
5. Press the flashing Blood pump button.
NOTE
After having started the blood pump again, the operator is
responsible for the monitoring of the venous pressure.

The blood pump now runs at a preset flow rate (preset: 25-500 ml/min).
During the rinse-back the venous clamp opens and closes 1 time/s in
order to maximize the emptying of the blood lines and the filter.
The blood pump stops, the Rinse-back button and the Blood pump
button start to flash and an attention appears. When a preset volume
(Preset: 200-5000 ml) of rinse-back solution has been returned to the
patient or when the priming detector does not detect blood any more,
which ever comes first.
6. Clamp the venous blood line and disconnect it from the patient.
To proceed, follow the instructions in Treatment operations-Emptying
and disconnecting the filter.

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Chapter 6
BPM - Blood Pressure Monitor
(option)
General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:2
The cuff . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:2
Handling BPM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:2
Patient factors affecting readings . . . . . . . . . . . . . . . . . . . . . . . . . . 6:3
Menus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:4
The first menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:4
The second menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:5
The third menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:5
Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:6
Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:7
Manual - single measuring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:8
Automatic - interval measuring . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:9
Continuous - five minutes measuring . . . . . . . . . . . . . . . . . . . . . . . 6:11
BPM Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:13

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General
The Blood Pressure Monitor (BPM) measures blood pressure and
pulse rate.
It is possible to use the BPM at any time whenever the machine is in its
on position i.e. when the ON/OFF button is lit.
In addition to the BPM included in the machine, a blood pressure
measurement cuff and a cuff hose are necessary.

The cuff
The line from the cuff (cuff hose) is attached to the side of the AK 95 S
(see Blood unit in chapter 2). The cuff and the cuff hose are
available in different sizes which can be ordered from your Gambro
representative (see List of concentrates, accessories and disposables,
for use with the AK 95 S).
It is important to use proper cuff size for accurate measurements. Use
the circumference of the patients arm to determine cuff size. If the
bladder is too wide, the blood pressure reading will be erroneously low;
if it is too narrow, the reading will be erroneously high. Apply the cuff
snugly so that one finger can fit between the cuff and the patients arm.
More information about how to choose the right cuff size, how to
connect the cuff to the cuff hose and the cuff hose to the machine can
be read in the package insert leaflet which is enclosed with the cuff
and cuff hose. The package insert leaflet also contains information
about how to properly put the cuff on the patient's arm.

Handling BPM
The BPM is handled via the information display using the BPM button,
the Select arrow button and the Set knob (see Operator's panel in
chapter 3).
Menus are shown on the information display when the BPM button
is pressed. Every time the BPM button is pressed the menus change
in sequence.
The Select arrow button is used to move within the menus (between
the subsections) on the information display.
The Set knob is used to move within the subsections in the menus on
the information display.
NOTE
If the BPM button is pressed when no BPM has been installed,
the information display will remain dark.

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CAUTION
1. Check that the blood circulation in the arm is not affected due
to blood pressure measurement checks.
2. The Blood Pressure Monitor must be used only for adult
patients or for children with a pediatric cuff and not for infant or
neonatal patients.
3. The manufacturer advises the user that the information
originating from the Blood Pressure Monitor cannot be used
alone as unique source of information to induce any therapeutic
or pharmacological actions.

Patient factors affecting readings


Excess patient movement can interfere with readings. Ensure that the
patient is not moving during readings, just as one would with manual
readings.
Avoid applying external pressure to the cuff during readings.
Some arrhythmias may cause pressure fluctuations that make obtaining
readings more difficult. If difficulty obtaining readings occurs in the
presence of arrhythmia, blood pressure should periodically be verified
by another method.

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Do not apply a blood pressure cuff to a limb with an access, e.g.


fistula or graft.

Do not apply a blood pressure cuff to a limb being monitored with


a pulse oximetry sensor.

Do not apply a cuff to a limb that has restricted blood flow.

Avoid applying a cuff to a limb that has an intravenous line in place.

AK 95 S Operators manual - BPM

6:3

Menus
The BPM shows three different menus on the information display
depending on whether the BPM button is pressed once, twice or three
times. The menus change in sequence every time the BPM button is
pressed.

The first menu


When the BPM button is pressed once the first menu is shown on the
information display. In this menu it is possible to read off the measured
values for systolic blood pressure, diastolic blood pressure, mean blood
pressure and pulse rate.
When blood pressure measurement checks have been performed the
latest measured values will be displayed as below:

Figure 6:1

Information display, BPM, the first menu with measured values

When a measurement check is in progress the current pressure in the


cuff will be displayed in the left part of the information display. As
soon as the measurement check is finished the new measured values
for blood pressure and pulse rate will be presented.
Information storage
The five previously performed measurement values can be displayed
starting with the latest, by turning the Set knob clockwise in the first
menu.

Figure 6:2

Information display, BPM, the first menu with previously measured values

The values are shown as below:


TIME shows current time for when the blood pressure measurement
check was carried out.
The value beside SYS shows systolic blood pressure.
The value beside DIA shows diastolic blood pressure.
The value beside MEAN shows mean blood pressure.
The value beside PLS shows pulse rate.

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The second menu


When the BPM button is pressed twice the second menu is shown on
the information display. In this menu it is possible to start and stop a
measurement check, change mode and activate alarms.
As soon as one enters the second menu START/STOP will flash.

Figure 6:3

Information display, BPM, second menu

The Select arrow button is used to move within the menu.


The Set knob is used to move within the subsections in the menu.

The third menu


When the BPM button is pressed a third time the third menu is shown
on the information display. In this menu it is possible to set the
alarm limits for blood pressure and pulse rate, and to set intervals for
automatic measuring.

Figure 6:4

Information display, BPM, third menu

The Select arrow button is used to move within the menu.


The Set knob is used to move within the subsections in the menu.

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Alarms
A BPM alarm is generated when a measured value is outside the set
alarm limits.
The BPM button and the MUTE button will flash and there will be a
soft buzzer signal. The measured values outside the set alarm limits
will flash on the information display.
Press the MUTE button (which will light up) in order to mute the
buzzer and/or press the BPM button in order to confirm the alarm.
Alarm limits can be adjusted at any time during treatment by the
operator. It is also possible for a technician responsible to preset the
alarm limits.
The alarm function can be turned to on or off 1 by pressing the BPM
button twice to reach the second menu, followed by using the Select
arrow button and the Set knob.
To set alarm limits:
1. Press the BPM button three times in order to reach the third menu.
2. Press the Select arrow button; SET ALARMS will flash.
3. Turn the Set knob clockwise step by step and four different displays
are shown.
4. Choose desired display, SYSTOLIC, DIASTOLIC, MEAN
PRESSURE or PULSE.

Figure 6:5

Information display, BPM, alarm limits set for systolic blood pressure

5. Press the Select arrow button to choose LOW or HIGH alarm limit,
selected alternative will flash.
6. Set a proper alarm limit by using the Set knob.
7. When the alarm limit(s) has been (have been) set, step out by
pressing the Hold button three times.
8. If more alarm limits are to be set, restart the procedure from
position 1.
Alarm ranges that can be set by the operator: 2
Systolic blood

Diastolic blood

Mean blood

pressure

pressure

pressure

Low alarm limit

100150

60100

75115

40150

High alarm limit

100150

60100

75115

40150

1
2

6:6

Pulse rate

Can be preset
Wider ranges can be preset by technician responsible
AK 95 S Operators manual - BPM

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Modes
The BPM can be used in three different modes; manual (MANUAL),
automatic (AUTO) and continuous (CONT). The BPM can also be set
to off (OFF) by entering MODE.
To set a mode:
1. Press the BPM button twice and the second menu will be displayed;
START/STOP will flash.
2. Press the Select arrow button once; MODE will flash.
3. Turn the Set knob clockwise until desired mode is shown; the
mode is activated.

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Manual - single measuring


In this mode the machine performs manually started single
measurement checks which can be performed whenever desired when
the machine is in its on position.
This mode is the default mode when the BPM button is pressed twice.
Before start:
If the alarm function is to be used, activate this by pressing the BPM
button twice and set ALARM to ON by using the Select arrow button
and the Set knob. To check or adjust alarm limits, see To set alarm
limits below Alarms in this chapter.
The pressure in the blood pressure measurement cuff will be
maximum 180 mmHg 3 the first time the blood pressure is being
measured when a blood pressure measurement check is carried out.
If there are difficulties obtaining the correct values there will be two
remeasurement checks with higher cuff pressure. If the measurement
checks still fail there will be an attention alarm to guide the operator to
take correct actions (see Attention alarm list in chapter 9).
To perform a single measurement check:
1. Press the BPM button twice (unlit information display); the second
menu will be displayed and START/STOP will flash.
2. Turn the Set knob clockwise and the measuring process will start.
The current pressure in the cuff will be displayed in the left part
of the information display. If the measuring process needs to be
interrupted, turn the Set knob anticlockwise.

Figure 6:6

Information display, BPM, performing single measurement check

3. The measuring result will be displayed on the information display


as soon as the measurement check is complete (see The first
menu in this chapter).
NOTE
It is always possible to interrupt a blood pressure measurement
check in progress, in any mode, by turning the Set knob
anticlockwise when START/STOP flashes in the second menu.

6:8

Can be preset
AK 95 S Operators manual - BPM

HCEN9794 Revision.08.2003
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Automatic - interval measuring


In this mode the machine performs measurement checks at set time
intervals.
If desired, it is always possible to start a single measurement check
between automatic measuring intervals. See handling procedure in
previous description.
Before start:
If the alarm function is to be used, activate this by pressing the BPM
button twice and set ALARM to ON by using the Select arrow button
and the Set knob. To check or adjust alarm limits, see To set alarm
limits below Alarms in this chapter.
The pressure in the blood pressure measurement cuff will be
maximum 180 mmHg4 the first time the blood pressure is being
measured when a blood pressure measurement check is carried out.
If there are difficulties obtaining the correct values there will be two
re-measurement checks with higher cuff pressure. If the measurement
checks still fail there will be an attention alarm to guide the operator to
take correct actions (see Attention alarm list in chapter 9).
To perform automatic measurement checks at intervals:
1. Press the BPM button twice (unlit information display); the second
menu will be displayed and START/STOP will flash.
2. Press the Select arrow button once; MODE will flash.
3. Turn the Set knob until AUTO is shown and the mode is activated.
4. Check that the time interval4 between the measurement checks are
correct by pressing the BPM button once more; the third menu
will be shown. If desired, press the Select arrow button twice and
adjust using the Set knob. The time intervals can be set between
560 minutes.

Figure 6:7
checks

Information display, BPM, adjusting time intervals between measurement

5. The first measurement check in the sequence will be performed


when the time for the first interval has ended, e.g. if the interval is
set to 20 minutes the first check will be 20 minutes after activation.
Time to next measurement check can be read in the second menu
(press the BPM button twice) below NEXT.

4
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Can be preset
AK 95 S Operators manual - BPM

6:9

6. The information display (second menu) will automatically


light up 30 seconds before the measurement check starts. The
current pressure in the cuff will be displayed in the left part of
the information display. If the measuring process needs to be
interrupted, turn the Set knob anticlockwise.
7. The measuring result will be displayed on the information display
as soon as the measurement check is complete (see The first
menu in this chapter).
NOTE
1. It is always possible to interrupt a blood pressure measurement
check in progress, in any mode, by turning the Set knob
anticlockwise when START/STOP flashes in the second menu.
2. After treatment, when the cuff is removed from the patient,
the blood pressure measurement will continue as set when
automatic or continuous mode is chosen. Manual mode or Off
has to be chosen to stop measurement. In order to keep the
five previously performed measurement values, manual mode
has to be chosen.

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Continuous - five minutes measuring


In this mode the machine continuously performs measurement checks
for 5 minutes.
Before start:
If the alarm function is to be used, activate this by pressing the BPM
button twice and set ALARM to ON by using the Select arrow button
and the Set knob. To check or adjust alarm limits, see To set alarm
limits below Alarms in this chapter.
Note Alarms will not appear during the 5 minute period with
continuous measurement checks. If alarms are generated, they will not
appear until the 5-minute period has been finished.
The pressure in the blood pressure measurement cuff will be
maximum 180 mmHg 5 the first time the blood pressure is being
measured when a blood pressure measurement check is carried out.
If there are difficulties obtaining the correct values there will be two
remeasurement checks with higher cuff pressure. If the measurement
checks still fail there will be an attention alarm to guide the operator to
take correct actions (see Attention alarm list in chapter 9).
To perform continuous measurement checks for 5 minutes:
1. Press the BPM button twice (unlit information display); the second
menu will be displayed and START/STOP will flash.
2. Press the Select arrow button once; MODE will flash.
3. Turn the Set knob until CONT is shown and the mode is activated.

Figure 6:8

Information display, BPM, continuous measuring

4. Start the 5-minute sequence of measuring checks by pressing the


Select arrow button twice until START/STOP flashes and turn
the Set knob clockwise. The current pressure in the cuff will be
displayed in the left part of the information display.
If,during this first measurement check in the sequence, the
measuring process needs to be interrupted, turn the Set knob
anticlockwise.
5. When the second measurement check in the sequence is
automatically started the measuring result from the latest previous
check in the sequence will be displayed on the information display.
The display will be lit during the whole period.
Note If the measuring process needs to be interrupted from this
point onwards; press the lit Hold button to change menu and turn
the Set knob anticlockwise.

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AK 95 S Operators manual - BPM

6:11

NOTE
1. It is always possible to interrupt a blood pressure measurement
check in progress, in any mode, by turning the Set knob
anticlockwise when START/STOP flashes in the second menu.
2. After treatment, when the cuff is removed from the patient,
the blood pressure measurement will continue as set when
automatic or continuous mode is chosen. Manual mode or Off
has to be chosen to stop measurement. In order to keep the
five previously performed measurement values, manual mode
has to be chosen.

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BPM Off
In this mode it is possible to turn the BPM to off.
To set the BPM to off:
1. Press the BPM button twice; the second menu will be displayed
and START/STOP will flash.
2. Press the Select arrow button once; MODE will flash.
3. Turn the Set knob until OFF is shown and the blood pressure
monitor is turned off.
NOTE
Previously measured values (see Information storage in this
chapter) will be deleted 10 seconds after the BPM has been
turned to off. In order to keep the values; set the BPM in
manual (MANUAL) mode and the values will be stored until
the machine is switched off.

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AK 95 S Operators manual - BPM

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Chapter 7
Disinfection and cleaning, Auto
heat, Auto rinse
Disinfection - general . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Heat disinfection and Decalcification . . . . . . . . . . . . . . . . . . . . . . . . .
Performing heat disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Properties of different disinfection, decalcification and cleaning agents
Chemical disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Automatic start of heat disinfection or rinsing program . . . . . . . . . . . .
Chemical disinfection procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Residual test after chemical disinfection . . . . . . . . . . . . . . . . . . . .
Cleaning - general . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Calcium carbonate precipitates . . . . . . . . . . . . . . . . . . . . . . . . . . .
Organic fouling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Iron fouling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
General guidelines for maintenance of the flow path . . . . . . . . . . .
Central disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Performing central disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . .
Rinse/Drain procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Rinse/Drain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
External cleaning of the machine . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Chemical disinfectants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Solutions based on peracetic acid . . . . . . . . . . . . . . . . . . . . . . . . . .
Sodium hypochlorite . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other disinfectants based on sodium hypochlorite . . . . . . . . . . . . .
Formaldehyde . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Exchange of ultrafilter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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AK 95 S Operators manual - Disinfection and cleaning, Auto heat, Auto rinse

7:1

Disinfection - general
The microbiological quality of the dialysis fluid depends on several
factors, such as:

The quality of the incoming water to the machine.

The quality of the dialysis concentrates.

The internal design of the dialysis machine.

The arrangement of the drain tube from the dialysis machine. The
drain tube must not be inserted into the drain receptacle, there must
be a sufficient air gap to avoid back-contamination from the sewer.

The methods and frequency of disinfection and internal cleaning


of the dialysis machine.
NOTE
The U 8000 S filter used in Ultra Filtered Dialysis Fluid kit is
to be exchanged regularly depending on the primary fluid
quality and the desired final fluid quality. The results from
microbiological controls have to determine the frequency of
exchange. A frequency between once a month and once every
three months can be expected.
It is recommended to have the machine filled with a disinfectant
when not in use, i.e. during nights and weekends, in order to
keep up a high standard in terms of microbiological quality of
the dialysis fluid.

All disinfection programs in the AK 95 S are tested in accordance


with the French standard NFS 90-304 and established to fulfil the
requirements expressed in the same standard.
There is no schedule that will guarantee the adequate microbiological
quality of the dialysis fluid. As a guideline, daily heat disinfection
combined with weekly chemical disinfection is recommended. Heat
disinfection should also be performed between treatments. It is more
efficient to use a heat disinfection program in combination with
decalcification (CleanCart-C or liquid citric acid) and this should be
performed at least daily. However, the adequacy of this schedule must
be validated by regular microbiological tests in the clinic.
The AK 95 S can be disinfected with either heat or chemicals. Check
that the dialysis fluid tubes are connected to the safety couplings before
disinfection is started.

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NOTE
An attention alarm appears when the machine is started if more
than 5 days 1 have passed since the last complete disinfection.
It is still possible to perform a treatment and the attention
light will switch off as soon as the priming button is pressed.
However, the attention alarm will appear again the next time
the machine is turned on, if a disinfection program has not been
completely carried out.

All disinfection programs can be interrupted by pressing the


Rinse/Drain button for more than 3 seconds. However, the rinsing
procedure for chemical disinfection will always have to be completed.
The disinfection time displayed is only an estimation and the "real
disinfection" time may vary.

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Heat disinfection and Decalcification


The manually started heat disinfection program (HEAT) begins with a
rinse in order to rinse out rests from the concentrates after the treatment.
During the heat disinfection program the inlet water is heated up
to 93 C and flushed through the fluid unit about 25 minutes. The
machine is then drained for 4 minutes. The total time for this program
is, if the machine is connected to 230 mains voltage, 33 minutes
(35 minutes if Ultra Filtered Dialysis Fluid Kit is installed).
It is possible to run a heat disinfection in combination with a citric acid
cleaning (Citric 20 %). Approx. 270 ml of 20 % 2 citric acid is diluted
in the machine and heated to 93 C. The total time for this program is,
if the machine is connected to 230 mains voltage, approx. 50 minutes
(52 minutes if Ultra Filtered Dialysis Fluid Kit is installed).
It is possible to run a heat disinfection in combination with CleanCart.
There are two different CleanCart programs that can be started:

Decalcification program with CleanCart-C

Cleaning program with CleanCart-A

The contents of the CleanCart is dissolved and heated to 93 C. The


total time for this program is, if the machine is connected to 230 mains
voltage, approx. 46 minutes (48 minutes if Ultra Filtered Dialysis
Fluid Kit is installed).
When AK 95 S is running with bicarbonate concentrates, there is
the possibility that calcium carbonate may deposit in the fluid path.
The general procedure to remove the deposits is a heat disinfection
program in combination with decalcification at least daily. The need
for decalcification is dependent on several parameters such as inlet
water quality, type of concentrates and actual bicarbonate settings used
during treatments.
The time required to perform a heat disinfection may vary depending
on the temperature of the incoming water. The time display always
shows the required time for cold incoming water. The time also varies
depending on which mains voltage the machine is connected to. (See
chapter 8). The dialysis fluid tubes must be connected to the safety
couplings and the concentrate connectors must be in the couplings
of the mixing unit.
NOTE
In order to enable the cleaning agents to remove fats, proteins
etc. efficiently, the cleaning is recommended to be carried out
after decalcification.

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Performing heat disinfection


1. Press the Heat disinf button briefly and select the desired procedure
with the Select arrow button:
Heat disinfection
Citric Acid 20 %3
CleanCart
The selected procedure is indicated by the flashing text on the
information display. Heat disinfection is the default3 procedure which
will be performed if nothing else is selected.
2. Confirm the choice by pressing the Heat Disinf button for
3 seconds (the button lights up). If combined Citric Heat or Clean
Cart Heat was chosen it will take 2-4 minutes after the program
has been confirmed before it is possible to connect the Citric acid
or the Clean Cart. There will be an attention alarm to notify the
operator to do so. This is due to the fact that manually started heat
disinfection programs begins with a rinse in order to rinse out rests
from the concentrates after the treatment.
If Combined Citric Heat was chosen:
2.a. When the attention:

appears (2-4 minutes after confirming), place the B-pick-up tube


in the container with citric acid solution. (The A-pick-up tube
connector should remain in the machine).
2.b. When the machine is filled with approx. 270 ml of solution the
attention:

is given. This is to instruct the operator to replace the pick-up tube


connector to the machine. When this has been done the heating
sequence starts and the temperature will rise.
If Combined CleanCart Heat was chosen:
2.a. When the attention:

appears (2-4 minutes after confirming), open the latches of the


holder and attach the CleanCart. Both pick-up tube connectors
should remain in the machine. The cartridge is left in the holder
during the entire program3.
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AK 95 S Operators manual - Disinfection and cleaning, Auto heat, Auto rinse

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2.b. If the attention:

appears, open the upper latch and press the flashing Heat Disinf
button until it illuminates. The CleanCart cartridge will now be
emptied. When the CleanCart is empty remove it and close the
latches.
3. If an automatic switch off is required, press the ON/OFF button
for 3 seconds.
4. When the heat disinfection program is completed and the machine
has been drained the Rinse/Drain button starts to flash.
If a new treatment is to be started, press the Reset or Rinse/Drain
button to start a new function check.
NOTE
1. The pick-up tubes must be disinfected and rinsed separately.
2. All the programs can be interrupted at any time by pressing the
Rinse/Drain button. The machine will then continue with a drain
sequence. (If chemicals have been used, a rinse and a drain.)

The machine can be preset to switch itself off after a complete


disinfection, i.e. when the Rinse/Drain button is flashing.

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Properties of different disinfection,


decalcification and cleaning agents
The following table below summarizes the properties of some generic
substances used for disinfection and internal cleaning of the AK 95 S.
Disinfecting and cleaning substances. For more specific information
about a certain commercial product, see the manufacturers data sheet.
Disinfection, decalcification and cleaning
Efficiency

Efficiency

Efficiency of

on inorganic

on organic

disinfection

precipitates

precipitates

Calcium

Iron
oxide

CleanCart-C and heat

High

Low

Low

High

CleanCart-A and heat

None

None

High

High

Peracetic acid 0.1 to 0.15 %

Low4

None

None

High

Citric acid liquid 2 % and heat

High

Low

Low

High

Sodium hypochlorite 0.5 %

None

None

High

High

Formaldehyde 4 %

None

None

None

High

Glutardialdehyde 2 %

None

None

None

High

Oxalic acid liquid 2 % and heat5

Low

High

None

High

The manufacturers of disinfectants based on peracetic acid claim


that these agents can also be used for decalcification. However,
experience has shown that you cannot rely on peracetic acid alone, use
CleanCart-C, citric acid or acetic acid regularly.
5 Oxalic acid is recommended only when having problems with iron
oxide precipitates (reddish-brown). Oxalic acid increases the wear
of the machine.
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7:7

Chemical disinfection
CAUTION
Disinfectants may be toxic. The user therefore must take note
of necessary precautions before use. The manufacturer's
instructions and recommendations have to be followed.

Different disinfectants can be used in three different chemical


disinfection programs.
Perace
Disinfectant:

Peracetic acid 3,5 %

Automatic dilution:

1+34

Consumption:

Approx 85 ml, without Ultra Filtered


Dialysis Fluid Kit
Approx. 92 ml, with Ultra Filtered
Dialysis Fluid Kit

Contact time:

10 min

Contact time overnight


or when not in use,
(recommended with
UFD-kit):

minimum 3 h

Total time:

28 min, without Ultra Filtered Dialysis


Fluid Kit
56 min, with Ultra Filtered Dialysis Fluid
Kit

Hypochlorite

7:8

Disinfectant:

Sodium hypochlorite (available chlorine


10 %)

Automatic dilution:

1+19

Consumption:

Approx. 145 ml, without Ultra Filtered


Dialysis Fluid Kit
Approx. 153 ml, with Ultra Filtered
Dialysis Fluid Kit

Contact time:

10 min

Contact time overnight or


when not in use:

not applicable

Total time:

28 min, without Ultra Filtered Dialysis


Fluid Kit
45 min, with Ultra Filtered Dialysis Fluid
Kit

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Formal*
Disinfectant:

Formaldehyde 37 %

Automatic dilution:

1+9

Consumption:

Approx 275 ml, without Ultra Filtered


Dialysis Fluid Kit
Approx. 290 ml, with Ultra Filtered
Dialysis Fluid Kit

Contact time:

20 min 6

Contact time overnight


or when not in use,
(recommended with
UFD-kit):

minimum 6 h

Total time:

117 min, without Ultra Filtered Dialysis


Fluid Kit
147 min, with Ultra Filtered Dialysis
Fluid Kit

For further information about disinfectants and brand names, see


Chemical disinfectants in this chapter.
* If Ultra Filtered Dialysis Fluid Kit is installed, the U 8000 S filter
must be exchanged prior to the following treatment. Alternatively
additional rinse/drain procedures can be performed according to
"Residual Test" section.

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Automatic start of heat disinfection or


rinsing program
This is a feature that enables the machine to automatically start a heat
disinfection program or a rinse program at a predetermined time.
The operator decides which day of the week and at what time of the
day the machine will be finished after having performed a heat/rinse
program. The machine can be programmed during any phase, i.e.
during treatment as well.
The machine must be connected to the water supply as well as to
power, when performing an auto heat/rinse program. The drain tube
must be connected to the drain.
1. Press the Auto Heat or the Auto Rinse button briefly in order to
lit up the display. There are four different positions showed in
the display window:
AUTO OFF/AUTO HEAT/AUTO RINSE, this position shows
if the function is activated or not.
TME NOW, shows the present day and time. Present time can
be changed by the operator, present day of the week must be
changed by the service technician responsible.
RDY DAY, in this position you can set which day you want the
auto function to be activated.
RDY TIME in this position you can set which time you want
the heat/rinse program to be finished.
2. Press the Select arrow button once; TME NOW will flash. Check
that the time displayed corresponds with the present time, if not,
adjust by using the Set knob.
3. Set the desired ready day (RDY DAY) and ready time (RDY
TIME) by using the Select arrow button and the Set knob in a
similar way, as above.
4. Activate the function by pressing the Auto Heat or Auto Rinse
button for 3 seconds (the button lights up).
If a weekly program is to be selected:
1. Press the Auto Heat or the Auto Rinse button briefly in order to
lit up the display.
2. Press the Select arrow button once; TME NOW will flash. Check
that the time displayed corresponds with the present time, if not,
adjust by using the Set knob.
3. Set the desired ready day (RDY DAY) and ready time (RDY
TIME) by using the Select arrow button and the Set knob in a
similar way, as above.
The automatic heat or rinse function can be switched off for the
selected day by setting the ready time to OFF (i.e. setting the time
between 23:59 h and 00:00 h)
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HCEN9794 Revision.08.2003
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4. Select the next day (RDY DAY) by using the Select arrow button
and the Set knob .
5. Select the ready time (RDY TIME) or the OFF function (see
above) for that day. Proceed according to the above instructions
until a complete weekly program has been set.
6. Activate the function by pressing the Auto Heat or Auto Rinse
button for 3 seconds (the button lights up).
NOTE
The buttons must also be pressed for 3 seconds (the light of
the button goes out) in order to deactivate the function.

A combined CleanCart auto heat can be performed by placing a


CleanCart in the holder, prior to an auto heat program.
The heat program started automatically will not start with a rinse as
it does when it is started manually. Therefore the auto heat program
will be 2-4 minutes shorter than the manually started program (see
chapter 8).
Remove the empty CleanCart before initiating the treatment.
The machine can be preset to switch itself off after a complete
disinfection, i.e. when the Rinse/Drain button is flashing.

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AK 95 S Operators manual - Disinfection and cleaning, Auto heat, Auto rinse

7:11

Chemical disinfection procedure


Check that the dialysis fluid tubes are connected to the safety
couplings, that the concentrate connectors are in the mixing unit, and
that the BiCart holder is empty and closed.
WARNING
DO NOT mix sodium hypochlorite with acid solutions such
as citric, acetic, oxalic or peracetic acids, this will produce
hazardous fumes (chlorine). Always make sure that a complete
rinse cycle is performed between consecutive cleaning
procedures.

CAUTION
Disinfectants may be toxic. The user must therefore take
necessary precautions before use. Follow the instructions and
recommendations from the manufacturer of the disinfectant.

There can be three different chemical disinfectants on the chemical


disinfection menu simultaneously. The default settings are: peracetic
acid (PERACE), sodium hypochlorite (HYPOCHL), and formaldehyde
(FORMAL).
PERACE is the default 7 procedure which will be performed if nothing
else is selected.
1. Press the Chem Disinf button briefly and choose the desired
disinfectant with the Select arrow button. The selected procedure
is indicated by the flashing text on the display.
2. Confirm the choice by pressing the Chem Disinf button for more
than 3 seconds (the button lights up).
3. Place the B pick-up tube in the container with the concentrated
disinfectant.
4. Return the B pick-up tube to the machine when the attention alarm
appears.
The machine can be preset to be left filled with a disinfectant overnight
(not hypochlorite). If the intention is to perform an overnight
disinfection, press the ON/OFF button at this point. 10 minutes after
the fill-phase has ended, the machine will switch off.
Rinsing starts automatically when the contact time has expired. It
consists of several fill and drain cycles. The Rinse/Drain button will
be illuminated when the rinse program starts. The Chem Disinf button
will remain illuminated throughout the program.

7:12

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HCEN9794 Revision.08.2003
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NOTE
1. The pick-up tubes must be disinfected and rinsed separately.
2. If the machine is left filled with a disinfectant overnight (not
hypochlorite), the rinse program will start immediately after
power on.

The disinfection procedure is completed when the Rinse/Drain button


begins to flash.
5. Switch the machine off by pressing the ON/OFF button for
3 seconds (the light goes out).
If a new treatment is to be started, press the Reset or Rinse/Drain
button to start a new function check.
Always remember that the machine must be checked for chemical
residuals after a chemical disinfection procedure.
The machine can be preset to switch itself off after a complete
disinfection, i.e. when the Rinse/Drain button is flashing.

Residual test after chemical disinfection


Before start of dialysis treatment a residual test must be done on the
prepared dialysis fluid.
This is to make sure that the patient will not be exposed to chemical
residuals after a chemical disinfection program.
1. Switch the machine on and let it pass function check (Fch) with the
proper concentrates attached.
2. When the green fluid path lights up, press the flashing Fluid
bypass button in order to let fresh dialysis fluid flow through the
dialysis fluid tubes.
3. Take the residual test sample from the flowing fluid on the dialysis
fluid outlet tube (to filter).
If the tests shows disinfectant residues:

DO NOT use connected BiCart.

Press the Rinse/Drain button for 3 seconds (the button lights up)
and start a new rinse/drain procedure. When this is finished, repeat
the handling procedure described above.

If the machine still shows disinfectant residues, contact service


technician.

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AK 95 S Operators manual - Disinfection and cleaning, Auto heat, Auto rinse

7:13

CAUTION
The operator has to verify after the disinfection procedure or
prior to the dialysis treatment that there are no residuals from
the chemical disinfectants in the machine or in the dialysis fluid.
The test has to be performed according to the recommendation
given by the manufacturer of the disinfection solution.

NOTE
The AK 95 S:s pick-up tubes must be disinfected and rinsed
separately.

7:14

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HCEN9794 Revision.08.2003
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Cleaning - general
NOTE
Periodic maintenance of the AK 95 S must be performed. See
the AK 95/AK95 S Maintenance Manual HCEN9137.

The fluid path in the dialysis machine is exposed to different forms of


contaminants, some of which may adhere to various surfaces in the
system. These contaminants will, eventually, impair the performance
of the machine. The cleaning requirements depend on several
factors, such as the water quality and type of concentrates used. A
well-organized cleaning schedule, based on the information below, is
therefore required to ensure high performance.

Calcium carbonate precipitates


Bicarbonate dialysis results in precipitation of calcium carbonate (lime)
in the fluid path. This leads to an increased frequency of conductivity
alarms.
A heat disinfection combined with Citric acid 20 % or CleanCart-C will
decalcificate the machine, i.e. it will remove the formed precipitation
of calcium carbonate (see Heat disinfection procedure).

Organic fouling
Organic substances, e.g. proteins and glucose, contaminate the
measuring electrodes of the ultrafiltration control system, resulting in
an increased frequency of technical errors.
WARNING
DO NOT mix sodium hypochlorite with acid solutions such
as citric, acetic, oxalic or peracetic acid as this will produce
hazardous fumes (chlorine). Always make sure that a complete
rinse cycle is performed between consecutive cleaning
procedures.

Iron fouling
Iron in the incoming water will coat the measuring electrodes of the
ultrafiltration control system with iron oxides (rust), resulting in an
increased frequency of technical errors. Iron oxides are effectively
removed by a 2 % solution of oxalic acid.

HCEN9794 Revision.08.2003
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AK 95 S Operators manual - Disinfection and cleaning, Auto heat, Auto rinse

7:15

General guidelines for maintenance of the flow path


The schedule below is a guideline for maintenance of the flow path and
may be adjusted to local conditions.
Daily, at least
Every week, at least

One heat disinfection program in


combination with CleanCart C or Citric
Acid.
One heat disinfection program in
combination with CleanCart C or Citric
Acid followed by a chemical disinfection
program with Sodium Hypochlorite or
a second heat disinfection program in
combination with CleanCart A.

NOTE
1. Improper cleaning of the UF-cell may be a contributing factor
for increased inaccuracy of the UF system. The use of
CleanCart-A in AK 95 S may have limited cleaning effect due
to the short contact phase in the cleaning program. If any
deviations in UF accuracy should occur, it is recommended to
use a more frequent cleaning with CleanCart-A or use sodium
hypochlorite instead.
2. In order to enable the cleaning agents to remove fats, proteins
etc. efficiently, the cleaning is recommended to be carried out
after decalcification.

7:16

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HCEN9794 Revision.08.2003
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Central disinfection
AK 95 S can be programmed to perform central chemical disinfection8.
In this mode, the machine is receiving disinfection solution through
the central water supply system. The central disinfection program in
AK 95 S performs a continuous rinse through the fluid monitor until
a preset time has passed or the operator has activated the rinse/drain
function.

Performing central disinfection


1. Press the Chem disinf button briefly.
2. Select CENTR DISINF with the Select arrow button.
3. Confirm the choice by pressing Chem disinf button for 3 seconds.
(The button lights up).
The machine is now performing a continuous rinse through all the
flow paths.
4. When the preset contact time8 has passed an attention is given to
indicate that the rinse/drain function can be started.
When no more chemicals are left in the central water supply system:
5. Start the rinse/drain procedure by pressing the Rinse/Drain button
for 3 seconds.
6. When the rinse/drain function is completed the button will flash.
CAUTION
The operator has to verify after the disinfection procedure or
prior to the dialysis treatment that there are no residuals in the
machine or in the dialysis fluid. The test has to be performed
according to the recommendation given by the manufacturer of
the disinfection solution.

The machine can be preset to switch itself off after a complete


disinfection, i.e. when the Rinse/Drain button is flashing.

8
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7:17

Rinse/Drain procedure
The dialysis fluid tubes must be connected to the safety couplings and
the concentrate connectors must be in the couplings of the mixing unit.

Rinse/Drain
1. Press the Rinse/Drain button for more than 3 seconds to start the
rinsing and draining function (10 min).
If the button is pressed a second time for more than 3 seconds an
immediate drain starts (4 min).
NOTE
In order to change the rinse time, press the Rinse/Drain button
briefly and change it directly by the Set knob . The temperature
can be changed by preset.

2. If an automatic switch off is required press the ON/OFF button


for 3 seconds.
3. When the rinse/drain program is completed the Rinse/Drain button
starts to flash.
4. Turn the machine off by pressing ON/OFF for 3 seconds, if an
automatic switch off has not been done.
If a new treatment is to be started, press the Reset or Rinse/Drain
button to start a new function check.
The machine can be preset to switch itself off after a complete
disinfection, i.e. when the Rinse/Drain button is flashing.

7:18

AK 95 S Operators manual - Disinfection and cleaning, Auto heat, Auto rinse

HCEN9794 Revision.08.2003
Program version 10.xx

External cleaning of the machine


Use ethanol 70 % (spiritus dilutes) or isopropanol 60 % for external
cleaning of the machine, if not otherwise stated. Wipe the exterior with
a moistened cloth.
CAUTION
Other solutions may dry and crack plastic materials and must
not be used.

Blood pump cleaning


Pull out the handle in the centre of the blood pump and turn to
disengage the roller assembly from the shaft. The roller assembly can
be cleaned and disinfected in ethanol 70 % or isopropanol 60 % and
can also be sterilized in an autoclave. To replace the roller assembly,
place it on the shaft, turn, and the first lock will engage. Continue
to turn while applying pressure to the locking handle and the second
lock will engage.
Blood leak detector cleaning
Unscrew the cover of the blood leak detector and clean the housing
with a soft, non-fluffy cloth, moistened with disinfectant solution.
When replacing the cover, make sure that the gasket is correctly placed.
Flow indicator cleaning
Take out the end plugs, remove the float and clean with a soft bottle
brush. Replace the lower plug, the float and the upper plug in this order.
Top tray cleaning
The top tray can be cleaned and disinfected in ethanol 70% or
isopropanol 60% and can also be sterilized in an autoclave.
CAUTION
In order to protect the internal parts of the AK 95 S against
spillage, the top tray must always be placed on the top of the
machine, except during technical service.

BPM cuff cleaning


Use a damp cloth with 70 % ethyl alcohol or 30 to 50 % isopropyl
alcohol for cleaning the surface of the cuff. Never put any solutions
inside the cuff. If this occurs, dry the inside of cuff before use.
The cloth covering of the cuff is removable and washable.

HCEN9794 Revision.08.2003
Program version 10.xx

AK 95 S Operators manual - Disinfection and cleaning, Auto heat, Auto rinse

7:19

The following procedure shown below is the procedure for taking the
rubber bladder out of the cloth bag.
In the cloth bag are holes for the rubber bladder and the rubber hose.
The large hole is used to put the rubber bladder through and the small
hole is used to put the rubber hose through. Figure A.
Put the rubber hose inside and pull out the inside cloth to make the
hole larger. Figure B and C.
Take the rubber bag out of the larger hole. Figure D.

Figure 7:1 BPM cuff, removal procedure of rubber bladder from cloth bag
1. Small hole
2. Large hole

Reverse the order when putting the rubber bladder in the cloth bag.
When the cloth bag of the cuff is removed, pay attention to the hole
through which the rubber hose of the rubber bladder goes. Unless the
hole is used, the rubber bag gets out of the cloth bag, leading to blow
out.

7:20

AK 95 S Operators manual - Disinfection and cleaning, Auto heat, Auto rinse

HCEN9794 Revision.08.2003
Program version 10.xx

Chemical disinfectants
Chemical disinfectants may be harmful to the materials used in the fluid
path of dialysis machines. Disinfectants may also contain additives
that cause foaming or are difficult to rinse out. The disinfectants listed
below are examples of chemicals recommended technically for use
in the AK 95 S, i.e. compatible with the materials in the machine,
provided that they are used in accordance with the recommendations
below. The efficiency of the disinfectant from a microbiological
standpoint must, however, be validated by the manufacturer of the
disinfectant and checked on a routine basis in the clinic.
CAUTION
The stated maximum dwell times below must be considered. A
longer dwell time may damage interior parts in the fluid path
and may cause a machine malfunction.

Solutions based on peracetic acid


Active ingredients:
Trade names:
Approved concentration:
Mixing instructions:
Dwell time:
Test for residuals:

HCEN9794 Revision.08.2003
Program version 10.xx

Peracetic acid and hydrogen peroxide.


Renalin, Actril, Acetoper, Puristeril 340,
Dialox, Peresal.
According to the instructions from the
manufacturer, however a maximum 0.15
% of peracetic acid.
Set the mixing ratio according to
the instructions for use from the
manufacturer.
Presettable but recommended to 10 min.
Not intended for overnight disinfection at
high concentration of active substances.
Iodine starch test strips (e.g.
Merckoquant 10011). Follow the
manufacturers recommendations.

AK 95 S Operators manual - Disinfection and cleaning, Auto heat, Auto rinse

7:21

Sodium hypochlorite
Active ingredients:
Approved concentration:
Mixing instructions:

Dwell time:
Test for residuals:

Sodium hypochlorite.
Weekly use: 0.5 % available chlorine.
Set the mixing ratios according to the
table below. Note that available chlorine
is approximately 70 % of the sodium
hypochlorite concentration. The table
below shows how to set different mixing
ratios for some concentrated sodium
hypochlorite solutions to obtain a 0.5 %
solution.
Maximum 20 minutes. Not intended for
overnight disinfection!
Chlorine Test Kits (e.g. Hach or Merck).

Concentrated solutions

Mixing ratio

ml

380

1 + 9

10

190

1 + 19

Other disinfectants based on sodium hypochlorite


Trade names:
Approved concentration:
Mixing instructions:
Dwell time:
Test for residuals:

Maranon H and Amuchina.


0.1 0.5 % of available chlorine or
according to recommendations from the
manufacturer.
Set the mixing ratio according to the
instruction for use from the manufacturer.
Maximum 20 minutes. Not intended for
overnight disinfection!
Follow the manufacturers
recommendations.

Formaldehyde
Active ingredient:
Formaldehyde.
Approved concentration : 4 %.
Mixing instructions:
Use 410 ml of a 37 % formaldehyde
solution (formalin) and set the mixing
ratio to 1+9.
Dwell time:
Unlimited.
Test for residuals:
e.g Formalert or Aquamerck 8028.

7:22

AK 95 S Operators manual - Disinfection and cleaning, Auto heat, Auto rinse

HCEN9794 Revision.08.2003
Program version 10.xx

Exchange of ultrafilter
NOTE
Make sure that the ultrafilters are exchanged in an aseptic way.

1. Release the lower part of the ultrafilter holder by pulling the handle
and pressing the latch downwards.
2. Remove the ultrafilter by pulling it gently downwards.
3. Insert the new ultrafilter into the holder and push it gently upwards.
4. Close the holder by pushing the lower latch into position.
5. Label the ultrafilter with date for exchange.
6. Perform a disinfection procedure before the AK 95 S is used for
treatment.
NOTE
The U 8000 S filter used in Ultra Filtered Dialysis Fluid kit is
to be exchanged regularly depending on the primary fluid
quality and the desired final fluid quality. The results from
microbiological controls have to determine the frequency of
exchange. A frequency between once a month and once every
three months can be expected.

HCEN9794 Revision.08.2003
Program version 10.xx

AK 95 S Operators manual - Disinfection and cleaning, Auto heat, Auto rinse

7:23

This page is intentionally left blank

7:24

Revision.08.2003
AK 95 S Operators manual - Disinfection and cleaning, Auto heat, Auto rinse HCEN9794
Program version 10.xx

Chapter 8
Technical data and specifications
Performance and specification - Control system . . . . . . . . . . . . . . . . .
Blood flow control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Heparin administration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Blood pressure control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Blood Pressure Monitor (BPM) . . . . . . . . . . . . . . . . . . . . . . . . . . .
Dialysis fluid preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Ultrafiltration control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Disinfection and cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Water supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Power supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Connection of external equipment . . . . . . . . . . . . . . . . . . . . . . . . .
Performance and specification - Supervisory system . . . . . . . . . . . . .
Blood pressure supervision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Extracorporeal blood loss to the environment . . . . . . . . . . . . . . . .
Air detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Extracorporeal blood loss due to coagulation . . . . . . . . . . . . . . . . .
Dialysis fluid preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Ultrafiltration supervision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Blood leakage detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
pH-meter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Physical data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Dimensions and weight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Infusion stand . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Materials in contact with dialysate, concentrates and water . . . . . . . .
Environmental data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

HCEN9794 Revision.08.2003
Program version 10.xx

AK 95 S Operators manual - Technical data and specifications

8:2
8:2
8:2
8:3
8:3
8:3
8:5
8:5
8:7
8:8
8:9
8:10
8:10
8:10
8:10
8:10
8:10
8:11
8:11
8:11
8:12
8:12
8:12
8:13
8:14
8:14
8:15
8:16

8:1

Performance and specification - Control


system
Blood flow control1
Double needle
Flow rate:

0 and 20 - 500 ml/min (-150 mmHg


prepump pressure, pump segment
diameter 7.9 mm)

Flow accuracy:

10 ml/min or 15 %, whichever is
largest

Accumulated blood volume:

0 - 327 litres

Volume accuracy:

0.6 l

treatment time (h) or 15%

Single needle
Flow rate:

0 and 20 - 500 ml/min (-150 mmHg


prepump pressure, pump segment
diameter 7.9 mm))

Flow accuracy:

10 ml/min or 18 %, whichever is
largest

Time control 2:

2 - 20 seconds (1 sec), arterial and


venous time.

Pressure control:

10 - 500 mmHg (50 mmHg), venous


pressure control

Accumulated blood volume:

0 to 327 litres

Volume accuracy:

0.6 l

treatment time (h) or 18%

Values for the blood pump(s) are based on a pressure of -150 mmHg before the
arterial blood pump with a pump segment of 7,9 mm. For pediatric blood tubes
with pump segment of 4.0 mm it is also possible to set blood flow to 5, 10 or 15
ml/min.

2 The

actual clamp opening time is depending on blood flow rate, size of expansion
chamber and pressure limits.

Heparin administration

8:2

Heparinization:

0 to 10 ml/h (1 ml/5h or 5%) The


accuracy is based on tests with 20 ml
and 30 ml syringes

Syringe size:

Syringes shall comply with ISO 7886-2.


Upon delivery, the machine is set for
a 20 ml Terumo syringe. Syringes of
other volumes and brands can be set.

Stop time:

Heparinization stops before end of


treatment 0.00 to 9.59 h

Counter pressure:

Maximum 400 mmHg

Accumulated heparin volume:

0 to 999.9 ml

AK 95 S Operators manual - Technical data and specifications

HCEN9794 Revision.08.2003
Program version 10.xx

Blood pressure control


Venous pressure:
Operating range

-700 to 750 mmHg

Alarm limits:

10 to 500 mmHg in treatment mode,-100


to 500 mmHg in priming mode

Accuracy:

-700 to -500 mmHg, 10 %-500 to 500


mmHg, 5 mmHg or 3 %, whichever
is largest500 to 750 mmHg, 10 %

Blood Pressure Monitor (BPM)


Systolic pressure range 3

60 - 250 mmHg

Low alarm limit, can be preset (Default)

60 - 250 mmHg (100 mmHg)

High alarm limit, can be preset (Default)

60 - 250 mmHg (150 mmHg)

Diastolic pressure range 3

40 - 220 mmHg

Low alarm limit, can be preset (Default)

40 - 220 mmHg (60 mmHg)

High alarm limit, can be preset (Default)

40 - 220 mmHg (100 mmHg)

Mean pressure range 3

45 - 235 mmHg

Low alarm limit, can be preset (Default)

45 - 235 mmHg (75 mmHg)

High alarm limit, can be preset (Default)

45 - 235 mmHg (115 mmHg)

3Meets

ANSI/AAMI SP-10 (1992). Mean error 5 mmHg. Standard deviation


8 mmHg

Pulse rate range

30 - 180 bpm (2 bpm or 2 % of


reading)

Low alarm limit, can be preset (Default)

30 - 180 bpm (40 bpm)

High alarm limit, can be preset (Default)

30 - 180 bpm (150 bpm)

Dialysis fluid preparation


Pressure regulators:

HCEN9794 Revision.08.2003
Program version 10.xx

After pressure
regulator PR
1and the heat
exchangers:

80 kPa (0.8 0.1


bar)

After pressure
regulator PR2:

130 10 mmHg

Temperature 4:

Adjustable 33 to 40 C

Alarm limits:

Adjustable 33 to 40 C

AK 95 S Operators manual - Technical data and specifications

8:3

Accuracy:

+0.5/-1.5 C (+1,0/-2.5 C with


UFD-kit) at the dialysis fluid outlet
from the machine.

Heater capacity:

1000 W (+10 % / -5 %) at 100 V1300


W (+10 % / -5 %) at 110 V1750 W
(+10 % / -5 %) at 230 V

Overheat protection:

Reg-temp 80 C or Cond A-temp 70


C in treatment, software Reg-temp
99 C in disinfection, software. The
heater can only be on if there is a
flow through the heater. The flow is
detected by a flow switch.

Accuracy is valid only if dialysis fluid temperature is greater or equal to ambient


temperature.

8:4

Flow rate:

300 or 500 ml/min

Accuracy:

10% or 50 ml/min whichever is


largest

Degassing:

By use of negative pressure , -610


mmHg. Adjustable degassing pressure
between -300 and -700 mmHg.

Accuracy:

40 mmHg

Dialysis fluid pressure:

-400 to +300 mmHg.

Accuracy:

10 mmHg or 5 %

Proportioning of concentrates:

The proportioning of concentrate is


done through conductivity control.
The concentrates are pumped into the
system with one/two volume trically
supervised pumps. No minimum
feeding pressure is necessary, the
fluid is sucked in. Maximum feeding
pressure, 150 kPa.

Acetate:

Na+ , 130 to 160 mmol/l, (3 mmol/l)

Bicarbonate:

Na+ , 130 to 160 mmol/l, (6


mmol/l)HCO3- , 20 to 40 mmol/l, (6
mmol/l)

Measuring range:

13 to 16 mS/cm

Alarm limits:

5 % of the calculated conductivity


set value

AK 95 S Operators manual - Technical data and specifications

HCEN9794 Revision.08.2003
Program version 10.xx

Ultrafiltration control
Volume control:

Direct electromagnetic measurement of


dialysis fluid flow, before and after the
dialyzer.

UF volume:

Adjustable 0 to 10.00 l

Accuracy of measured volume:

50 ml/h or 1 % whichever is largest

UF coefficient:

Maximum 83 ml/h/mmHg

UF rate:

0.0 to 4 l/h, given by the set values of


UF volume and treatment time.

Time:

Remaining treatment time control. 0.05


to 9.59 hour. minute (1 minute)

Disinfection and cleaning


Chemical disinfection

Peracetic Acid Program (presetable)


Concentration

3.5 % peracetic acid

Volume

approx. 85 ml (with UFD-kit approx.


92 ml)

Contact time between treatments

10 minutes

Contact time overnight or when not in


use (recommended with UFD-kit)

Minimum 3h dwell time

Total time

30 minutes (with UFD-kit 59 minutes)


including 10 min contact time

Hypochlorite Program (presetable)


Concentration

10 % available chlorine

Volume

Approx. 145 ml (with UFD-kit approx.


153 ml)

Contact time between treatments

10 minutes

Contact time overnight or when not in


use

Maximum 20 min, not intended for


overnight disinfection!

Total time

30 minutes (with UFD-kit 48


minutes)including 10 min contact time

Formaldehyde Program (presetable)

HCEN9794 Revision.08.2003
Program version 10.xx

Concentration

37 % formaldehyde

Volume

Approx. 275 ml (with UFD-kit approx.


290 ml)

Contact time between treatments

20 min

AK 95 S Operators manual - Technical data and specifications

8:5

Contact time overnight or when not in


use (recommended with UFD-kit)

Minimum 6h dwell time

Total time

119 minutes (with UFD-kit 150 minutes)


including 20 min contact time

Heat disinfection

One of three alternatives for heat disinfection can be selected. The second alternative is presetable for a combined heating program and the third is a CleanCart /
heating alternative. The default settings are as follows.

AK 95 S

With
UFD
installed

Without
UFD

Disinfection
programs

Total Time [min]


230 V

110 V

100 V

Heat

35

39

49

Heat Citric acid


20 %

52

57

67

Heat CleanCart

48

54

63

Heat

33

37

47

Heat Citric acid


20 %

50

55

65

Heat CleanCart

46

51

60

Auto Heat disinfection


Auto Heat can be used with or without CleanCart. If the Auto Heat shall be
performed with CleanCart must the cartridge be installed before the Auto Heat
starts.
AK 95

With UFD
installed

Without UFD

8:6

Disinfection
programs

Total Time [min]


230 V

110 V

100 V

Heat

31

35

45

Heat
CleanCart

43

49

58

Heat

31

35

45

Heat
CleanCart

43

48

58

AK 95 S Operators manual - Technical data and specifications

HCEN9794 Revision.08.2003
Program version 10.xx

Temperature:

+93C (measured after heating


rod)80C (measured in the outlet
before the heat exchanger )

Note:

The temperatures are verified at


nominal values for the mains voltage
and at 20C ambient temperature.

Rinse/Drain:
Rinse/Drain

10 minutes

Drain

4 minutes

Exterior cleaning:

All outside parts of the machine can


be cleaned with ethanol (70%) or
isopropanol (60%).

NOTE
Total Time for Disinfection Programs are estimated and may vary.

Water supply

HCEN9794 Revision.08.2003
Program version 10.xx

Flow rate:

During treatment: maximum 550


ml/minDuring disinfection and
rinse/drain: a maximum flow rate of
800 ml/min is required.

Minimum inlet pressure:

0.12 MPa (1.2 bar)

Maximum inlet pressure:

0.6 MPa (6 bar)

Inlet temperature:

Treatment: +5 to +30 CDisinfection:


+5 to +90 C

Connector in/outlet:

Diameter 8 mm

Quality:

The quality of water for preparing


the dialysis fluid should comply with
applicable international and national
standards, e.g. ANSI/AAMI. To
achieve proper machine function, the
conductivity of the water used for
preparing the dialysis fluid should not
exceed 50S/cm. Currently reverse
osmosis is the most reliable and most
commonly used water treatment to
reach this quality level of maximum 50
S/cm.

Drain:

The drain tube outlet must be placed


between floor level and maximum 1.2
m above the outlet connection from the
fluid monitor. An air gap to atmospheric
pressure must always be arranged at the
tube outlet.

Length of drain tube:

<5 m

AK 95 S Operators manual - Technical data and specifications

8:7

High pressure guard transducer:

500 mmHg, (10 mmHg or 5 %,


whichever is largest)

Inlet pressure switch (INPS):

Increasing: +150 mmHg, 20


mmHgDecreasing: +99 mmHg, 20
mmHg

Safety guard switch (SAGS):

Increasing: -59 mmHg, 7


mmHgDecreasing: -74 mmHg,
7 mmHg

Power supply

8:8

Mains voltage:

100 V(at 50 Hz or 60 Hz) , 110 V(at 50


Hz or 60 Hz) or 230 V(at 50 Hz or 60
Hz) (,AC), (12%). The voltage has to
be specified before installation.

Note:

The user must verify the quality of the


protective earth in the installation.

Power consumption:

2025W at 230V1575W at 110V1275W


at 100V

Cable length:

3m

Cable area:

AWG 16 at 100V and 110V1mm2 at


230V

External fuses:

For 100/110 V, 2 x 10AT for heater and


2 fuses specified by Philips (se AC/DC
unit K15740 008) For 230V, 2 x 10AT
for heater and 2 fuses specified by
Philips (se AC/DC unit K15740 007)

Mains plug:

For 100/110V, Hospital grade, earth


plug, type IEC 83 A5-15For 230V, Dual
earth system plug, type IEC 83 C4

Maximum earth leakage current:

100 A (100V)150 A (110V)205 A


(230V, 50 Hz )400 A (230V, 60 Hz )

Maximum patient leakage current:

9 A (100V)11 A (110V) 20 A
(230V)

Note:

All leakage currents specified are


without external equipment connected
to the AK 95 S.

AK 95 S Operators manual - Technical data and specifications

HCEN9794 Revision.08.2003
Program version 10.xx

Connection of external equipment


External
connector:

25 pin D-Sub with RS-232C or RS-422/Current loop. Opto


insulated fulfilling IEC 60601-1-1.

External
equipment:

External equipment intended for connection to signal input,


signal output or other connectors, shall comply with relevant
IEC standard (e.g. IEC 60950 for IT equipment and the IEC
60601 series for medical electrical equipment). In addition,
all such combinations - systems - shall comply with the
standard IEC 60601-1-1, Safety requirements for medical
electrical systems. Equipment not complying to IEC 60601
shall be kept outside the patient environment, as defined in
the standard. 1)Any person who connects external equipment
to signal input, signal output or other connectors has formed
a system and is therefore responsible for the system to
comply with the requirements of IEC 60601-1-1. If in doubt,
contact qualified technician or your local representative.1)
The normal distance can be mentioned i.e. at least 1.5 m from
the patient or the patient support.

Extern alarm:

Max voltage:

24 V

AC or DC

Max current:

100 mA

AC or DC

Max input voltage:

15 V

DC

High level min


output voltage:

5.0 V

DC

Low level max


output voltage:

-5.0 V

DC

Max output
current:

5 mA

DC

Typ current:

20 mA

DC

Max current:

50 mA

DC

RS-232C:

RS-422/Current
loop:

HCEN9794 Revision.08.2003
Program version 10.xx

AK 95 S Operators manual - Technical data and specifications

8:9

Performance and specification - Supervisory


system
Blood pressure supervision
Venous pressure:
Operating range

-700 to 750 mmHg

Alarm limits:

10 to 500 mmHg in treatment mode,-100


to 500 mmHg in priming mode

Accuracy:

-700 to -500 mmHg, 10 %-500 to 500


mmHg, 5 mmHg or 3 %, whichever
is largest500 to 750 mmHg, 10 %

Arterial pressure:
Operating range

-700 to 750 mmHg

Alarm limits:

-700 to 750 mmHg

Accuracy:

-700 to -500 mmHg, 10 %-500 to 500


mmHg, 5 mmHg or 3 %, whichever
is largest500 to 750 mmHg, 10 %

Extracorporeal blood loss to the environment


Detection method:

Venous pressure supervision

Air detection
Detection method:

Ultrasonic detector placed at the venous


drip chamber. The detector has a two
channel structure and the function of
the detector is tested at the function test
made by the microcomputers.

Drip chamber size:

Diameter 22 mm

Sensitivity:

Bubbles larger than 1 l will be trapped


by the drip chamber. An alarm will be
issued if the blood level falls below the
middle of the air detector.

Extracorporeal blood loss due to coagulation


Detection method:

Supervision of the stop time of the


blood pump

Alarm:

The attention BLOOD PUMP STOP


TIME EXPIRED, Start Blood pump.

Dialysis fluid preparation


Temperature:
Temperature alarm (fixed)

8:10

40 C (0.5 C)

AK 95 S Operators manual - Technical data and specifications

HCEN9794 Revision.08.2003
Program version 10.xx

Overheat protection:

The heater can only be on if there is a


flow through the heater. The flow is
detected by a flow switch.

Conductivity:
Alarm limits:

5 % of the calculated conductivity set


value

Ultrafiltration supervision
TMP:

TMP is defined as the difference, Pb


P d out, where Pb out is the venous
pressure and P d out is the pressure
measured in the dialysis fluid, where it
enters the machine after the dialyzer.
out -

Alarm limits:

-100 to 500 mmHg

Accuracy:

500 ( 10 mmHg or 5 %, whichever


is largest )

Blood leakage detection


Detection method:

Infrared light detector.

Sensitivity:

Alarm will be given for 0.3 ml blood,


haematocrit 32%, per minute at 500
ml/min dialysis fluid flow. Time
delay for alarm, maximum 5 seconds
(diffusion mode).

pH-meter

HCEN9794 Revision.08.2003
Program version 10.xx

Measuring range:

1 - 9.9 pH, measured in the dialysis


fluid before dialyzer.

Accuracy:

0.2 pH

Alarm limits:

5.0 to 9.0 pH

AK 95 S Operators manual - Technical data and specifications

8:11

Physical data
Dimensions and weight
Width:

Approx. Machine 480 mm, stand 580


mm.

Depth:

Approx. Machine 600 mm, stand 625


mm.

Height:

Approx. 1270 mm (without infusion


stand).

Weight:

Approx. 78 kg (all options included)

Infusion stand
Maximum total load:

8:12

2 kg

AK 95 S Operators manual - Technical data and specifications

HCEN9794 Revision.08.2003
Program version 10.xx

Materials in contact with dialysate,


concentrates and water
Polymers
Silicon rubber
Santroprene
PVC (Polyvinylchloride)
PEEK (Polyetherketone)
PEX (Polyethylene)
PP (Polypropylene)
PSU (Polysulphone)
PVDF (Polyvinylidene fluoride)
PTFE (Polytetrafluoro ethylene)

Metals
Stainless steel SS2343
Stainless steel SS2353
Stainless steel SS2562
Titanium
Platinum

Others
Carbon
Ceramic, Steatite 221
Ceramic, Aluminium oxide (Al2O3)
Glass

HCEN9794 Revision.08.2003
Program version 10.xx

AK 95 S Operators manual - Technical data and specifications

8:13

Environmental data
Operation

Ambient Temperature range

+18 to +35 C

Relative Humidity range

15 to 85 % RH

Air Pressure range ( atm. Pressure )

700 to 1060 hPa

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.

Transportation and storage 6


Ambient Temperature range

-20 to +70 C

Relative Humidity range

10 to 96 % RH

Air Pressure range ( atm. Pressure )

500 to 1060 hPa

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.

8:14

AK 95 S Operators manual - Technical data and specifications

HCEN9794 Revision.08.2003
Program version 10.xx

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 60601-1-1 Safety requirements for medical electrical systems
IEC 60601-1-2 Electromagnetic compatibility
EN 1060-1 Non-invasive sphygmomanometers Part 1: General
requirements
EN 1060-1 Non-invasive sphygmomanometers Part 3: Supplementary
requirements for electromechanical blood pressure measuring systems

HCEN9794 Revision.08.2003
Program version 10.xx

AK 95 S Operators manual - Technical data and specifications

8:15

References
Assembly Drawing K23000

8:16

AK 95 S Operators manual - Technical data and specifications

HCEN9794 Revision.08.2003
Program version 10.xx

Chapter 9
Alarm lists
Alarm list . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9:2
Attention alarm list . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9:10
Technical alarm list . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9:41

HCEN9794 Revision.08.2003
Program version 10.xx

AK 95 S Operators manual - Alarm lists

9:1

Alarm list
Light:
Steady
Mute time:
2 min
Additional information:
Low limit:
Blood pump stops
Venous clamp closes
Minimum UF rate (when blood is detected)
When pressure is within limits again, the blood pump starts and the
venous clamp opens.
If the Venous pressure button is pressed for 3 seconds the low limit
alarm is overridden for 5 - 120 1seconds.
High limit:
Blood pump stops
Minimum UF rate (when blood is detected)
When pressure is within limits again, the blood pump starts and the
venous clamp opens
Possible cause:
Low alarm:
The blood line has separated from the filter.
The blood line has separated at the arterial or venous side of the access.
The blood position of the venous needle has changed.
Clotting before or in the filter.
High alarm:
The venous blood line is kinked or clamped.
The position of the venous needle has changed.
Clotting has occurred after the venous pressure measurement e.g. in
the blood line, in the venous drip chamber or in the needle.
Light:
Flashing
Mute time:
2 min
Additional information:
Alarm limits are too wide.
After 2 minutes an attention alarm appears.
Possible cause:
-

9:2

Can be preset
AK 95 S Operators manual - Alarm lists

HCEN9794 Revision.08.2003
Program version 10.xx

Light:
Steady
Mute time:
2 min
Additional information:
Possible cause:
The blood flow has been lower than the low alarm limit for more than
the preset time.
The blood pump has been left in stop position too long due to an alarm.
The operator has left the blood pump in stop position too long.
Light:
Steady
Mute time:
2 min
Additional information:
Possible cause:
The stroke volume during SN is lower than the set low alarm limit.
Light:
Steady
Mute time:
2 min
Additional information:
Dialysis fluid bypass.
When the temperature is within limits again, the fluid enters the
dialyzer automatically.
Possible cause:
Low alarm:
The machine has not yet stabilized the temperature after an interruption
of the water supply.
High alarm:
The temperature of the incoming water is too high.
The machine has not yet stabilized the temperature after the function
check.

HCEN9794 Revision.08.2003
Program version 10.xx

AK 95 S Operators manual - Alarm lists

9:3

Light:
Steady
Mute time:
2 min
Additional information:
Dialysis fluid bypass
When the conductivity is within limits again, the fluid enters the filter
automatically
Possible cause:
Low alarm:
The concentrate container/BiCart cartridge is empty.
The concentrate has not been connected.
Incorrect concentrate has been connected.
The proper concentrate has not been selected on the display.
There is an interruption in the concentrate administration to the
machine e.g. the connector is not properly connected to the pick-up
tube, the concentrate line is kinked or occluded.
Air is drawn into the machine instead of concentrate.
The filter(s) of the concentrate(s) is/are clogged.
The content of the concentrate container does not correspond to the
specifications given.
High alarm:
Incorrect concentrate has been connected.
The proper concentrate has not been selected on the display.
The content of the concentrate container does not correspond to the
specifications given.

9:4

AK 95 S Operators manual - Alarm lists

HCEN9794 Revision.08.2003
Program version 10.xx

Light:
Steady
Mute time:
2 min
Additional information:
Low limit
Blood pump stops
Venous clamp closes
Min. UF rate (when blood is detected)
When the pressure is within limits again, the blood pump starts and
the venous clamp opens.
If the Arterial pressure button is pressed for 3 seconds the low limit
and high alarms is overridden for 5 - 120 2 seconds.
High limit
Blood pump stops
Venous clamp closes
Min. UF rate (when blood is detected)
When pressure is within limits again, the blood pump starts and the
venous clamp opens
Possible cause:
Low alarm:
The position of the arterial needle has been changed.
The arterial blood line is kinked or clotted between the arterial access
and the arterial pressure measurement.
The set blood flow rate exceeds the blood flow that the arterial access
has possibility to deliver.
The position of the arterial needle has changed.
High alarm:
The blood line has separated at the arterial side of the access.
The position of the arterial needle has changed.
Air or infusion enters the arterial line between the arterial access and
the blood pump e.g. when a pre blood pump infusion is connected.
Light:
Flashing
Mute time:
2 min
Additional information:
Alarm limits are too wide.
After 2 minutes an attention also appears.
Possible cause:
-

2
HCEN9794 Revision.08.2003
Program version 10.xx

Can be preset
AK 95 S Operators manual - Alarm lists

9:5

Light:
Steady
Mute time:
2 min
Additional information:
The TMP is outside the preset limits
Possible cause:
Low alarm
The set value for the treatment time has been increased or the set value
for the UF volume has been decreased during treatment.
Venous pressure decreases during treatment.
Changes in the UF-control system that can cause reduced accuracy
in the weight loss of the patient.
High alarm
The set value for the treatment time has been decreased or the set value
for the UF volume has been increased.
Venous pressure increases during treatment.
Partly clogged dialyzer.
Changes in the UF-control system that can cause reduced accuracy
in the weight loss of the patient.
Light:
Flashing
Mute time:
2 min
Additional information:
Alarm limits are too wide
After 2 minutes an attention alarm appears.
Possible cause:
-

.....
......
.......

Light:
Steady
Mute time:
2 min
Additional information:
Possible cause:
The connection to the external computer system has been interrupted.

9:6

AK 95 S Operators manual - Alarm lists

HCEN9794 Revision.08.2003
Program version 10.xx

Light:
Flashing
Mute time:
2 min
Additional information:
An attention appears simultaneously
Possible cause:
No UF volume has been set when the machine detects blood.
Light:
Steady
Mute time:
2 min
Additional information:
An attention appears simultaneously
Possible cause:
Calculated set UF rate is lower than minimum UF rate set value.
Light:
Steady
Mute time:
2 min
Additional information:
Blood pump stops
Arterial clamps closes.
Venous clamps closes.
If the Air detect button is pressed for 3 seconds the alarm is overridden
for 0 - 120 3 seconds.
Possible cause:
Blood line(s) not properly connected at e.g. the arterial needle
connection, the filter connection(s), the infusion port(s). Blood line(s)
or the filter not properly de-aired during priming.
An empty infusion container with air inlet is connected to the blood
line(s).
The arterial needle is dislocated.

3
HCEN9794 Revision.08.2003
Program version 10.xx

Can be preset
AK 95 S Operators manual - Alarm lists

9:7

Light:
Flashing
Mute time:
2 min
Additional information:
Appears after an Air detect alarm
Press the Air detect button to confirm
Possible cause:
Light:
Steady
Mute time:
2 min
Additional information:
The pH is outside the limits
Possible cause:
The content of the concentrate container does not correspond to the
specifications given.
Incorrect concentrate has been connected.
Either the acid container or the bicarbonate container/BiCart cartridge
has been emptied during bicarbonate treatment.
Light:
Steady
Mute time:
2 min
Additional information:
Blood pump stops
Arterial clamps closes.
UF rate decreases and the dialysis fluid is bypassed.
If the Blood leak button is pressed for 3 seconds the alarm actions are
overridden for 5 -120 4seconds.
After treatment when the priming detector does not detect blood, the
blood leak alarm is delayed 30 seconds
Possible cause:
A leakage, which allows blood to flow from the blood compartment to
the dialysis fluid compartment, has occurred. Air bubbles or particles,
which can cause a false blood leak alarm, have entered the blood leak
detector.

9:8

Can be preset
AK 95 S Operators manual - Alarm lists

HCEN9794 Revision.08.2003
Program version 10.xx

Light:
Flashing
Mute time:
2 min
Additional information:
Appears after a Blood leak alarm.
Press the Blood leak button to confirm
Possible cause:
Light:
Flashing
Mute time:
Infinite
Additional information:
The systolic, diastolic or mean blood pressure or the pulse rate is
outside the alarm limits set.
Possible cause:
Light:
Flashing
Mute time:
2 min
Additional information:
An attention appears simultaneously
Possible cause:
The heparin rate has been set to zero when the machine detects blood.
Light:
Flashing
Mute time:
Infinite
Additional information:
An attention appears simultaneously
Possible cause:
Treatment time has expired.

HCEN9794 Revision.08.2003
Program version 10.xx

AK 95 S Operators manual - Alarm lists

9:9

Attention alarm list


The attention alarms are described in alphabetic order.
A - PICK UP TUBE
IMPROPER POSITION
Mute time:
2 min
Additional information:
Buzzer is delayed 2 min.
Buzzer sound:
Supersoft buzzer

Adjust pump head to tube X.XX mm


Press BLOOD FLOW key to confirm
Mute time:
2 min
Additional information:
Appears after a change of the blood pump segments has been done.
The occlusion of the blood pump head must be manually adjusted.
Buzzer sound:
Soft buzzer

AIR DETECTOR NOT ACTIVATED


Press AIR DETECTOR key
Mute time:
Additional information:
Buzzer sound:
No buzzer

9:10

AK 95 S Operators manual - Alarm lists

HCEN9794 Revision.08.2003
Program version 10.xx

AIR LEAKAGE
Check fluid tubes connections
Mute time:
2 min
Additional information:
Buzzer is delayed 2 min.
Appears when dialysate tubes are not properly connected to filter and
priming detector detects blood
CAUTION
Incorrect weight loss may occur if the machine is left for a
longer period with this attention.

Buzzer sound:
Soft buzzer

ART PRESSURE LIMITS TOO WIDE


Press ARTERIAL key to adjust
Mute time:
2 min
Additional information:
Alarm limits are too wide.
Buzzer sound:
Soft buzzer

AUTO PRIMING
Waiting for dialysis fluid
Mute time:
Additional information:
Appears during autopriming, press the Fluid bypass button.
Buzzer sound:
No buzzer

HCEN9794 Revision.08.2003
Program version 10.xx

AK 95 S Operators manual - Alarm lists

9:11

B/ACETATE - PICK UP TUBE


IMPROPER POSITION
Mute time:
5 min
Additional information:
Buzzer is delayed 2 min.
Buzzer sound:
Supersoft buzzer

BATTERY FAILURE
Change battery or press SELECT
Mute time:
Infinite
Additional information:
Press the Select arrow button to confirm the information. The attention
alarm appears in Fch and also after treatment, when blood is no longer
sensed, as a reminder.
The alarm is to let the operator know that change or recharge of the
battery is needed. If the attention is confirmed without change or
recharge of the battery the machine will not be able to alarm or restart
in case of power failure.
The attention can be confirmed for three succeeding treatments. The
fourth time the battery failure occurs a technical error is generated and
the battery must be changed or recharged.
Buzzer sound:
Soft buzzer (in F.Ch) No buzzer (in disinf.)

BiCart emptied
press SELECT to confirm
Mute time:
Additional information:
Appears when the emptying of the BiCart is completed.
Buzzer sound:
No buzzer

9:12

AK 95 S Operators manual - Alarm lists

HCEN9794 Revision.08.2003
Program version 10.xx

BiCart HOLDER NOT CLOSED


Close or check BiCart holder
Mute time:
2 min
Additional information:
Buzzer is delayed 2 min.
Buzzer sound:
Soft buzzer

BiCart HOLDER NOT INSTALLED


Check concentrate selection
Mute time:
2 min
Additional information:
Buzzer sound:
Soft buzzer

BiCart NOT ATTACHED TO HOLDER


Attach or check BiCart
Mute time:
Infinite
Additional information:
Buzzer is delayed for 2 min.
Buzzer sound:
Soft buzzer

HCEN9794 Revision.08.2003
Program version 10.xx

AK 95 S Operators manual - Alarm lists

9:13

BLOOD DETECTED IN AUTO PRIMING


Mute time:
Infinite
Additional information:
May occur during autopriming.
Buzzer sound:
Soft buzzer

BLOOD IN PRIMING DETECTOR


Function check stopped
Mute time:
Infinite
Additional information:
Priming detector detects blood during function check. Clean the
window of the priming detector.
Buzzer sound:
Continuous buzzer

BLOOD LEAK DETECTOR FAILURE


Clean and press BLOODLEAK key
Mute time:
Infinite
Additional information:
Will only appear during Fch.
Buzzer sound:
Soft buzzer

9:14

AK 95 S Operators manual - Alarm lists

HCEN9794 Revision.08.2003
Program version 10.xx

BLOOD PATH PRESSURE TEST FAILED


Press SELECT key to continue
Mute time:
Infinite
Additional information:
May occur during auto priming if the leakage test of the dialyzer fails.
Buzzer sound:
Soft buzzer

BLOOD PUMP COVER NOT CLOSED


Close blood pump cover
Mute time:
2 min
Additional information:
Blood pump stops
Buzzer sound:
Soft buzzer

BLOOD PUMP OVERLOAD IN FCH


Check the pump and press SELECT
Mute time:
Infinite
Additional information:
Buzzer sound:
Soft buzzer

HCEN9794 Revision.08.2003
Program version 10.xx

AK 95 S Operators manual - Alarm lists

9:15

BLOOD PUMP OVERLOAD


Press BLOOD PUMP key
Mute time:
2 min
Additional information:
Blood pump stops
Buzzer sound:
Soft buzzer

BLOOD PUMP STOP TIME EXPIRED


Start Blood pump
Mute time:
2 min
Additional information:
Appears 1 minute after blood pump is stopped.
Buzzer sound:
Continuous buzzer

BPM FAILURE
Turn off BPM
Mute time:
Infinite
Additional information:
An error is detected by the BPM. Turn the BPM off and then on again.
Buzzer sound:
Soft buzzer

9:16

AK 95 S Operators manual - Alarm lists

HCEN9794 Revision.08.2003
Program version 10.xx

CENTRAL CHEM DISINF. COMPLETED


Press RINSE/DRAIN
Mute time:
Infinite
Additional information:
Will appear when the preset contact time in central disinfection has
passed.
Buzzer sound:
Supersoft buzzer

CHEM DIS FILLUP PHASE COMPLETED


Place pick up tube in machine
Mute time:
Infinite
Additional information:
Buzzer sound:
Supersoft buzzer

CHEMICAL FILLUP NOT SUFFICIENT


Check supply of disinfectant
Mute time:
Infinite
Additional information:
Check pick-up tube and disinfectant container.
Buzzer sound:
Supersoft buzzer

HCEN9794 Revision.08.2003
Program version 10.xx

AK 95 S Operators manual - Alarm lists

9:17

CleanCart FILL COMPLETED


Open upper latch and press HEAT
Mute time:
Infinite
Additional information:
CleanCart disinf. with the latches closed after fill phase.
Buzzer sound:
Supersoft buzzer

CleanCart FILL COMPLETED


Open upper latch and press RINSE
Mute time:
Infinite
Additional information:
CleanCart rinse with the latches closed after fill phase.
Buzzer sound:
Supersoft buzzer

CleanCart NOT ATTACHED TO HOLDER


Attach or check CleanCart
Mute time:
Infinite
Additional information:
Buzzer is delayed 1 minute.
Buzzer sound:
Supersoft buzzer

9:18

AK 95 S Operators manual - Alarm lists

HCEN9794 Revision.08.2003
Program version 10.xx

CLEANING REQUIRED
xx hours since last cleaning
Mute time:
Infinite
Additional information:
Will disappear as soon as priming is activated.
Buzzer sound:
Soft buzzer

Connect concentrate when time to


prepare machine for treatment
Mute time:
Infinite
Additional information:
No concentrate(s) added.
Buzzer sound:
Soft buzzer

DECALCIFICATION REQUIRED
XX hours since last decalcific.
Mute time:
Infinite
Additional information:
Will disappear as soon as priming is activated.
Buzzer sound:
Supersoft buzzer

HCEN9794 Revision.08.2003
Program version 10.xx

AK 95 S Operators manual - Alarm lists

9:19

Dialysis flow too low


Mute time:
Infinite
Additional information:
Appears during treatment when the dialysis fluid flow rate is out of
range. Call for service technician, there is an obstruction in the dialysis
fluid flow path. If the attention alarm is left without taking measures, it
will reappear in the next treatment.
Buzzer sound:
Soft buzzer

Dialysis fluid not ready for


treatment. Fluid ready in xxx s
Mute time:
Infinite
Additional information:
Do not start treatment until the attention has disappeared.
The fluid flow path is being flushed with dialysis fluid; please wait
the displayed time.
Appears when UFD-kit is installed, the dialysis fluid connectors are not
attached to the machine and the Fluid bypass button has been pressed.
Buzzer sound:
Soft buzzer

DIALYSIS FLUID READY


PRESS BYPASS KEY
Mute time:
Additional information:
Appears after FCh, press the Fluid Bypass button to flush the dialysis
fluid tubes for 30 seconds.
Buzzer sound:
No buzzer

9:20

AK 95 S Operators manual - Alarm lists

HCEN9794 Revision.08.2003
Program version 10.xx

DISCONNECT ARTERIAL PRESSURE


Press ARTERIAL key to confirm
Mute time:
5 min
Additional information:
Occurs during function check if an arterial pressure more than
2 mmHg is measured.
Buzzer sound:
Soft buzzer

DISCONNECT VENOUS PRESSURE


Press VENOUS key to confirm
Mute time:
5 min
Additional information:
Occurs during function check if a venous pressure more than 2 mmHg
is measured.
Buzzer sound:
Soft buzzer

DISINFECTION REQUIRED
xx days since last disinfection
Mute time:
Infinite
Additional information:
Will disappear as soon as priming is activated.
Buzzer sound:
Supersoft buzzer

HCEN9794 Revision.08.2003
Program version 10.xx

AK 95 S Operators manual - Alarm lists

9:21

EXIT AUTO PRIMING


Place arterial line in clamp
Mute time:
Infinite
Additional information:
Appears after autopriming when the venous drip chamber level
adjustment has been done.
Buzzer sound:
Soft buzzer

EXTRA PRIMING VOLUME ACHIEVED


Mute time:
2 min
Additional information:
If this attention appears during initiation of the treatment, check that
the venous line is properly inserted into the priming detector.
Buzzer sound:
Soft buzzer

FLUID BYPASS TIME EXPIRED


Press BYPASS key
Mute time:
2 min
Additional information:
Appears 5 minutes after dialysis fluid is bypassed.
Buzzer sound:
Soft buzzer

9:22

AK 95 S Operators manual - Alarm lists

HCEN9794 Revision.08.2003
Program version 10.xx

FLUID PATH OBSTRUCTION


Check fluid tubes and dialyzer
Mute time:
2 min
Additional information:
An obstruction has been detected. Check if the obstruction is external
i.e. in the fluid tubes or in the filter by pressing Fluid Bypass button.
If attention disappears the obstruction is external.
Buzzer sound:
Continuous buzzer

FLUID TUBE SENSOR TEST PART 1(2)


Remove tubes, press SELECT, wait
Mute time:
2 min
Additional information:
Buzzer sound:
Soft buzzer

FLUID TUBE SENSOR TEST PART 2(2)


Attach fluid tubes, press SELECT
Mute time:
2 min
Additional information:
Buzzer sound:
Soft buzzer

HCEN9794 Revision.08.2003
Program version 10.xx

AK 95 S Operators manual - Alarm lists

9:23

FLUID TUBES IN SAFETY BYPASS


Connect fluid tubes to dialyzer
Mute time:
2 min
Additional information:
The fluid tubes are still in safety bypass when blood is detected by
the priming detector.
Buzzer sound:
Soft buzzer

FLUID TUBES IN SAFETY BYPASS


Connect fluid tubes to dialyzer
Mute time:
2 min
Additional information:
The fluid tubes are returned to safety bypass during treatment. Buzzer
delayed 5 min.
Buzzer sound:
Supersoft buzzer

FLUID TUBES NOT IN SAFETY BYPASS


Mute time:
2 min
Additional information:
Buzzer is delayed 2 min.
Function check is stopped disinf/rinse can not be started.
Buzzer sound:
Soft buzzer

9:24

AK 95 S Operators manual - Alarm lists

HCEN9794 Revision.08.2003
Program version 10.xx

FUNCTION CHECK RESTARTED


Please wait
Mute time:
Additional information:
Function check is restarted and therefore prolonged.
Buzzer sound:
No buzzer

HEATER EFFICIENCY NOT SUFFICIENT


FOR PROPER DISINFECTION
Mute time:
2 min
Additional information:
Insufficient heat during the heat program. Press Select arrow button.
Buzzer sound:
No buzzer

HEPARIN PUMP OVERLOAD


Check heparin syringe and line
Mute time:
2 min
Additional information:
Heparin pump stops.
Buzzer sound:
Soft buzzer

HCEN9794 Revision.08.2003
Program version 10.xx

AK 95 S Operators manual - Alarm lists

9:25

HEPARIN SET TO ZERO


Press HEPARIN key to confirm
Mute time:
2 min
Additional information:
Buzzer is delayed 2 min.
Appears when priming detector detects blood.
Buzzer sound:
Soft buzzer

High conductivity not obtained


Check concentrate
Mute time:
Infinite
Additional information:
Appears during Fch.
Check pick-up tube and container.
Buzzer sound:
Soft buzzer

HIGH MONITOR TEMPERATURE ALARM


Turn off the monitor
Mute time:
Infinite
Additional information:
Appears when electronic circuit board temperature exceeds 55 C.
Buzzer sound:
Soft buzzer

9:26

AK 95 S Operators manual - Alarm lists

HCEN9794 Revision.08.2003
Program version 10.xx

IMPOSSIBLE AUTO START SETTING


Check auto heat/rinse ready time
Mute time:
2 min
Additional information:
Buzzer sound:
Soft buzzer

IMPOSSIBLE TIME OR UF SETTING


Adjust TIME or UF VOLUME
Mute time:
2 min
Additional information:
Buzzer is delayed 2 min.
The high UF rate is reached.
Adjust Time or UF volume until calculated UF rate is lower than high
limit
Buzzer sound:
Soft buzzer

INCORRECT ACIDIC CONCENTRATE


Check concentrate
Mute time:
2 min
Additional information:
Buzzer sound:
Soft buzzer

HCEN9794 Revision.08.2003
Program version 10.xx

AK 95 S Operators manual - Alarm lists

9:27

INCORRECT BICARBONATE CONC


Check concentrate
Mute time:
2 min
Additional information:
Buzzer sound:
Soft buzzer

INCORRECT CONCENTRATE
Check concentrate
Mute time:
2 min
Additional information:
Buzzer sound:
Soft buzzer

INCORRECT DIALYSIS FLUID


COMPOSITION
Mute time:
2 min
Additional information:
Check concentrates
Appears in bicarbonate mode.
Buzzer sound:
Soft buzzer

9:28

AK 95 S Operators manual - Alarm lists

HCEN9794 Revision.08.2003
Program version 10.xx

INSUFFICIENT INLET PRESSURE


Please check water supply
Mute time:
2 min
Additional information:
Buzzer is delayed 5 min in priming phase but not delayed in disinf.
or treatment phase.
Buzzer sound:
Soft buzzer

LOW UF RATE CAN NOT BE OBTAINED


Venous pressure too high
Mute time:
5 min
Additional information:
The positive pressure limit is reached (negative TMP).
Check the dialyzer (clotted?) and the venous pressure (high pressure
measurement?)
Correct accordingly.
Adjust Time and UF volume until measured UF rate is lower than
calculated.
Buzzer sound:
Soft buzzer

HCEN9794 Revision.08.2003
Program version 10.xx

AK 95 S Operators manual - Alarm lists

9:29

NEGATIVE UF RATE
Check and press UF volume
Mute time:
2 min
Additional information:
Relative negative UF volume of 500 ml or negative UF rate >50
ml/min for 5 min. Check for "blockage" of the draining tube. After
correction of the fault, press the UF volume button for 3 sec. for
confirmation. Check the UF rate before leaving the machine, if this is
not correct call for technical service.
CAUTION
Incorrect weight loss may occur if confirmation is done without
having corrected the cause for the attention.

Buzzer sound:
Soft buzzer

NO BACKFILTRATION WARNING
Press TMP to confirm
Mute time:
2 min
Additional information:
The TMP alarm limits are set below zero mmHg and no backfiltration
warning will occur. This attention needs confirmation.
This attention can be removed by preset.
Buzzer sound:
Soft buzzer

9:30

AK 95 S Operators manual - Alarm lists

HCEN9794 Revision.08.2003
Program version 10.xx

NO BPM VALUES
Check BPM cuff
Mute time:
Infinite
Additional information:
Buzzer delayed 2 min.
It was not possible to measure the patient's blood pressure. Check that
the cuff is correctly applied to the patient. It could also be that the
patient is moving during the measurement check.
Buzzer sound:
Soft buzzer

NO CHANGE IN BLOOD PRESSURE


Check cause, press BLOODPUMP key
Mute time:
2 min
Additional information:
Venous pressure is stable during SN.
Buzzer sound:
Soft buzzer

NO CUFF ATTACHED
Attach or check BPM cuff
Mute time:
Infinite
Additional information:
Buzzer delayed 2 min.
Check for kinks or leakage from the cuff and the cuff hose. Check also
that the cuff hose is properly connected to the machine.
Buzzer sound:
Soft buzzer

HCEN9794 Revision.08.2003
Program version 10.xx

AK 95 S Operators manual - Alarm lists

9:31

NOT ENOUGH DISINFECTANT


Mute time:
Additional information:
May appear if a working solution is selected but not if a concentrated
solution is selected.
Buzzer sound:
Supersoft buzzer

ONLY BLOOD MONITOR IS RUNNING


Press SELECT to start fluid part
Mute time:
Infinite
Additional information:
Only the blood unit starts after a power failure. The fluid unit has to
be started manually
Buzzer sound:
Supersoft buzzer

PLEASE WAIT 30 SEC. TO


BYPASS DIALYSIS FLUID
Mute time:
2 min
Additional information:
Appears if the Fluid bypass button is pressed during the flushing of the
dialysis fluid tubes.
This attention can be removed by preset.
Buzzer sound:
Soft buzzer

9:32

AK 95 S Operators manual - Alarm lists

HCEN9794 Revision.08.2003
Program version 10.xx

PRIMING VOLUME ACHIEVED


Mute time:
2 min
Additional information:
If this attention appears during initiation of the treatment, check that
the venous line is properly inserted into the priming detector.
Buzzer sound:
Soft buzzer

READY FOR VENOUS PRESSURE TEST


Press VENOUS key to start
Mute time:
Additional information:
Buzzer sound:
No buzzer

RECOVERED FROM POWER FAILURE


Press TIME key to confirm
Mute time:
2 min
Additional information:
Time display shows rec until Time button is pressed.
Buzzer sound:
Soft buzzer

HCEN9794 Revision.08.2003
Program version 10.xx

AK 95 S Operators manual - Alarm lists

9:33

RINSE BACK VOLUME ACHIEVED


Mute time:
5 min
Additional information:
Occurs during automatic rinse back
Buzzer sound:
Soft buzzer

SAGS TEST FAILED


Mute time:
Infinite
Additional information:
Check if the AK 95 S is connected to the water supply.
Buzzer sound:
Soft buzzer

TMP LIMITS TOO WIDE


Press TMP key to adjust
Mute time:
2 min
Additional information:
Alarm limits are too wide.
Buzzer sound:
Soft buzzer

9:34

AK 95 S Operators manual - Alarm lists

HCEN9794 Revision.08.2003
Program version 10.xx

To empty BiCart, press SELECT


Mute time:
Additional information:
Appears when emptying of the BiCart has been initiated by pressing
the Bicarbonate button twice.
Buzzer sound:
No buzzer

To end treatment, press isol UF


and zero time
Mute time:
Additional information:
Appears if treatment time is turned down to zero and there is still time
left under Isol UF.
Buzzer sound:
-

To obtain total UF volume


ISOL UF must be started
Mute time:
Infinite
Additional information:
Appears when the remaining total time is = set isolated UF time +
2 min.
Buzzer sound:
Soft buzzer

HCEN9794 Revision.08.2003
Program version 10.xx

AK 95 S Operators manual - Alarm lists

9:35

To start final flush,


press BLOOD PUMP key
Mute time:
Additional information:
Appears in autopriming when final flush is to be done.
Buzzer sound:
No buzzer

To start the air detector test:


Fill the venous drip chamber
Mute time:
Additional information:
The venous drip chamber must be filled with priming solution in order
to start the air detector test and to finalize the function test.
Buzzer sound:
No buzzer

TOO HIGH TMP REQUIRED


Increase time or decrease UF volume
Mute time:
2 min
Additional information:
Buzzer is delayed 2 min.
The negative pressure limit is reached (high positive TMP).
Check the dialyzer (too small/partly clotted? and correct accordingly.
Adjust Time and UF volume until TMP decreases.
Buzzer sound:
Soft buzzer

9:36

AK 95 S Operators manual - Alarm lists

HCEN9794 Revision.08.2003
Program version 10.xx

TREATMENT STARTED NO RESET MADE


Press SELECT if OK, else RESET
Mute time:
Infinite
Additional information:
Buzzer sound:
Soft buzzer

TREATMENT TIME EXPIRED


Press TIME for 3 sec to confirm
Mute time:
Infinite
Additional information:
Buzzer sound:
Supersoft buzzer

UF RATE LIMIT REACHED


Re-adjust TIME or UF VOLUME
Mute time:
2 min
Additional information:
Buzzer is delayed 2 min
The 20 % limit on UF rate has been reached.
The cause may be a stopped UF for too long.
Adjust Time and UF volume or allow for a new UF rate limit
calculation (press either Time or UF volume and then Select Arrow
button).
Buzzer sound:
Soft buzzer

HCEN9794 Revision.08.2003
Program version 10.xx

AK 95 S Operators manual - Alarm lists

9:37

UF RATE LOWER THAN MINIMUM SET


Adjust TIME, UF VOLUME or MIN UF
Mute time:
2 min
Additional information:
Buzzer is delayed 2 min.
Calculated set UF rate is lower than minimum UF rate set value.
Buzzer sound:
Soft buzzer

UF STOP TIME EXPIRED


Press START/STOP key
Mute time:
5 min
Additional information:
Appears 5 min after START/STOP button is pressed.
Buzzer sound:
Supersoft buzzer

UF VOLUME SET TO ZERO


Press UF VOLUME key to confirm
Mute time:
2 min
Additional information:
Buzzer is delayed 2 min.
Appears when the priming detector detects blood.
Buzzer sound:
Soft buzzer

9:38

AK 95 S Operators manual - Alarm lists

HCEN9794 Revision.08.2003
Program version 10.xx

VENOUS LOW LIMIT BELOW +10 mmHg


Press VENOUS key to adjust
Mute time:
2 min
Additional information:
Appears 10 min (presettable 2 - 20) after the low limit has been set
below + 10 mmHg.
Buzzer sound:
Continuous buzzer

VENOUS PRESSURE LIMITS TOO WIDE


Press VENOUS key to adjust
Mute time:
2 min
Additional information:
Alarm limits are too wide.
Buzzer sound:
Soft buzzer

VENOUS PRESSURE TEST INTERRUPTED


Press SELECT to confirm
Mute time:
2 min
Additional information:
Buzzer sound:
Soft buzzer

HCEN9794 Revision.08.2003
Program version 10.xx

AK 95 S Operators manual - Alarm lists

9:39

Wrong disinfectant agent


Press SELECT to restart disinf.
Mute time:
2 min
Additional information:
A too high or too low disinfectant concentration has been detected.
Check cause and press Select arrow button shortly to repeat fill phase.
Buzzer sound:
Supersoft buzzer

9:40

AK 95 S Operators manual - Alarm lists

HCEN9794 Revision.08.2003
Program version 10.xx

Technical alarm list

TECHNICAL MESSAGE CALL SERVICE


x xxx xxx xxx
Mute time:
Additional information:
A technical message has appeared, call for a service technician.
Depending on the message, the machine sometimes enters a patient
safe state which makes it impossible to continue.

HCEN9794 Revision.08.2003
Program version 10.xx

AK 95 S Operators manual - Alarm lists

9:41

This page is intentionally left blank

9:42

AK 95 S Operators manual - Alarm lists

HCEN9794 Revision.08.2003
Program version 10.xx

Chapter 10
Major changes
Major changes in operators manual from program version 9.xx to
10.xx . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Complete manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Chapter 1 and 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Chapter 6 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Chapter 7 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Chapter 9 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
The minual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

HCEN9794 Revision.08.2003
Program version 10.xx

AK 95 SOperators manual - Major Changes

10:2
10:2
10:2
10:2
10:2
10:2
10:2

10:1

Major changes in operators manual from


program version 9.xx to 10.xx
Complete manual
The figures contains a small reference number, vertically written.
The AK 95 S does not support treatments using plate filters anymore.
Valid texts removed from manual.

Chapter 1 and 2
The machine is provided with a connector for potential equalization to
minimize the risk of electric shock when using central venous catheters.
A Caution is added in the Caution list in General precautions before
use in chapter 1 and a new position is added in Blood unit in chapter
2.

Chapter 6
A new chapter is added ; BPM - Blood Pressure Monitor (option).
The chapter includes instructions how to use the BPM function of the
machine.

Chapter 7
Present time of the day can now be changed by the operator when
performing Automatic start of heat disinfection or rinsing program.

Chapter 9
There are three new attention alarms added in the attention alarm list
connected to the BPM function:
BPM FAILURE
Turn off BPM
and
NO BPM VALUES
Check BPM cuff
and
NO CUFF ATTACHED
Attach or check BPM cuff

The minual
is removed from the manual for the time being.

10:2

AK 95 SOperators manual - Major Changes

HCEN9794 Revision.08.2003
Program version 10.xx

Chapter 11
Index

HCEN9794 Revision.08.2003
Program version 10.xx

AK 95 S Operators manual - Index

11:1

A
Acetate . . . . . . . . . . . . . . . 3:25
Acetate button . . . . . . . . . . . 3:7
Acetoper . . . . . . . . . . . . . . 7:21
Actril . . . . . . . . . . . . . . . . . 7:21
Air detector . . . . . . . . . . . . . 2:2
Alarm function of the parameter
buttons . . . . . . . . . . . . . . . 3:16
Alarm indicators . . . . . . . . 3:15
Alarm list . . . . . . . . . . . . . . 9:2
Alarms . . . . . . . . . . . . . . . . 3:15
Amuchina . . . . . . . . . . . . . 7:22
Appliance inlet . . . . . . . . . . 2:8
Aquamerck . . . . . . . . . . . . 7:22
Arterial and venous line
clamps . . . . . . . . . . . . . . . . 2:3
Arterial blood line . . . . . . . . 4:6
Arterial line guide . . . . . . . . 2:3
Arterial pressure alarm . . . 3:16
Arterial pressure transducer
connector . . . . . . . . . . . . . . 2:3
Attaching the filter and the blood
lines . . . . . . . . . . . . . . . . . . 4:5
Attention alarm list . . . . . . 9:10
Auto Heat button . . . . . . . . . 3:6
Auto Rinse button . . . . . . . . 3:6

B
Bargraph display . . . . . . . . . 3:4
Bars, lifting positions . . . . . 2:6
Bicarbonate . . . . . . . . . . . . 3:25
Bicarbonate button . . . . . . . 3:7
BiCart holder . . . . . . . . . . . . 2:6
Blood flow . . . . . . . . . . . . 3:25
Blood flow knob . . . . . 3:5, 3:22
Blood leak detector . . . . . . . 2:4
Blood path . . . . . . . . . . . . . . 3:8
Blood pressure measurement
accessories . . . . . . . . . . . . 1:12
Blood pump . . . . . . . . . 2:3, 3:19
Blood pump alarm . . . . . . . 3:16
Blood unit . . . . . . . . . . . . . . 2:2
Blue concentrate connector with
white tube marking . . . . . . 2:7
BPM - Blood Pressure Monitor
Handling instructions . . . 6:1
BPM - five minutes
measuring . . . . . . . . . . . . 6:11
BPM - interval measuring . . 6:9
BPM - single measuring . . . 6:8
BPM alarms . . . . . . . . . . . . 6:6
BPM connection . . . . . . . . . 2:3
BPM cuff . . . . . . . . . . . . . . . 6:2
BPM information storage . . 6:4
BPM menus . . . . . . . . . . . . . 6:4

BPM modes . . . . . . . . . . . . . 6:7


BPM Off . . . . . . . . . . . . . . 6:13
Bypass path . . . . . . . . . . . . . 3:8

C
Caution . . . . . . . . . . . . . . . . 1:2
CE-marking . . . . . . . . . . . . 1:15
Central disinfection . . . . . . 7:17
Centralizing alarm . . . . . . . 3:16
Change of blood pump
segments . . . . . . . . . . . . . 3:31
Chemical disinfectants . . . 7:21
Chemical disinfection . 7:8, 3:25
Chemical disinfection
button . . . . . . . . . . . . . . . . 3:6
Chlorine Test Kits . . . . . . . 7:22
Cleaning - general . . . . . . . 7:15
Clinic Automation alarm . . 3:17
Concentrates . . . . . . . . . . . 1:10
Conductivity . . . . . . . . . . . 3:26
Conductivity alarm . . . . . . 3:16
control system . . . . . . . . . . . 1:6

D
Definitions of expressions . . 1:2
Dialox . . . . . . . . . . . . . . . . 7:21
Dialysis fluid inlet (from
filter) . . . . . . . . . . . . . . . . . 2:4
Dialysis fluid outlet (to
filter) . . . . . . . . . . . . . . . . . 2:4
Discontinuing dialysis . . . . 4:24
Disinfection ports . . . . . . . . 2:7
Disinfection, and cleaning Auto
heat, Auto rinse . . . . . . . . . 7:1
Display and setting group . 3:21
double clamp function . . . . . 1:5
Drain . . . . . . . . . . . . . . . . . . 2:8

E
Exchange of ultrafilter . . . 7:23
Expansion chamber holder . 2:3
External cleaning of the
machine . . . . . . . . . . . . . . 7:19

F
Filter . . . . . . . . . . . . . . . . . . 4:5
Filter holder . . . . . . . . . . . . . 2:3
Filter path . . . . . . . . . . . . . . 3:8
Filters . . . . . . . . . . . . . . . . 1:11
Flow diagram . . . . . . . . 3:4, 3:8
Fluid bypass button . . . . . . 3:20
Fluid unit . . . . . . . . . . . . . . . 2:4
Formaldehyde . . . . . . . . . . 7:22
Formalert . . . . . . . . . . . . . . 7:22
Fuses . . . . . . . . . . . . . . . . . . 2:8

AK 95 S Operators manual - Index

HCEN9794 Revision.08.2003
Program version 10.xx

G
General precautions before
use . . . . . . . . . . . . . . . . . . . 1:3

H
Hach . . . . . . . . . . . . . . . . . 7:22
Heat disinfection . . . . . . . . 3:25
Heat disinfection and
Decalcification . . . . . . . . . 7:4
Heat disinfection button . . . 3:6
Heparin pump . . . . . . . . . . . 2:3
Heparin pump alarm . . . . . 3:17
heparinization . . . . . . . . . . . 4:8
High venous pressure test . 4:14
Hydrogen peroxide . . . . . . 7:21
Hygiene group . . . . . . . . . . . 3:6

I
Information display . . . 3:5, 3:21
Infusion stand . . . . . . . . . . . 2:8
Initial procedures . . . . . . . . 4:2
Initiating dialysis . . . . . . . . 4:15
Intended use . . . . . . . . . . . . 1:5
Interface connection . . . . . . 2:8
Iodine starch test strips . . . 7:21
Isol UF button . . . . . . . . . . . 3:7

L
Level adjustment knob . . . . 2:3
Lines . . . . . . . . . . . . . . . . . 1:11
List of concentrates, accessories
and disposables . . . . . . . . 1:10
List of symbols . . . . . . . . . 1:13

M
Main switch . . . . . . . . . . . . . 2:8
Maranon H . . . . . . . . . . . . 7:22
Merck . . . . . . . . . . . . . . . . 7:22
Merckoquant 10011 . . . . . 7:21
Mode buttons and Parameter
buttons and their displays . 3:9
Mode group . . . . . . . . . . . . . 3:7
Mute . . . . . . . . . . . . . . . . . 3:20

N
Note . . . . . . . . . . . . . . . . . . . 1:2

O
ON/OFF button . . . . . . . . . . 3:6
Operator's panel . . . . . . 2:2, 3:4
Other disinfectants . . . . . . 7:22
Override . . . . . . . . . . . . . . 3:18

P
Peracetic acid . . . . . . . . . . 7:21
HCEN9794 Revision.08.2003
Program version 10.xx

Peresal . . . . . . . . . . . . . . . . 7:21
Potential equalization . . . . 2:3
1:4, 1:14
Power failure . . . . . . 3:29 3:30
Priming and rinsing . . . . . . 4:12
Priming detector . . . . . . . . . 2:3
protective system . . . . . . . . 1:6
Puristeril 340 . . . . . . . . . . . 7:21

R
recirculation in single-needle
treatment . . . . . . . . . . . . . 4:20
Recovery from power
failure . . . . . . . . . . . . . . . 3:29
Red concentrate connector . 2:6
Renalin . . . . . . . . . . . . . . . 7:21
Residual test . . . . . . . . . . . 7:13
Returning the blood . . . . . . 4:24
Rinse/Drain . . . . . . . . . . . . 3:25
Rinse/Drain button . . . . . . . 3:6
Rinse/Drain procedure . . . 7:18

S
Safety couplings . . . . . . . . . 2:4
Safety philosophy . . . . . . . . 1:6
Service frame . . . . . . . . . . . 2:6
Set knob . . . . . . . . . . . 3:5, 3:22
Setting of parameters . . . . 3:24
Single Fault Conditions . . . . 1:6
Single needle data . . . . . . . 3:25
Single needle data alarm . . 3:16
SN button . . . . . . . . . . . . . . 3:7
Sodium hypochlorite . . . . . 7:22
Soft pac hook . . . . . . . . . . . 2:3
Stand-by group . . . . . . . . . 3:19
Start the machine . . . . . . . . . 4:3
Start UF Stop . . . . . . . . . . . 3:20

T
Temperature . . . . . . . . . . . 3:25
Temperature alarm . . . . . . 3:16
The eight commandments . 3:23
Time . . . . . . . . . . . . . . . . . 3:26
Time attention alarm . . . . . 3:17
Time display . . . . . . . . . . . . 3:4
Top tray . . . . . . . . . . . . . . . . 2:2
Transmembrane pressure
alarm . . . . . . . . . . . . . . . . 3:16
Tray for concentrate
containers . . . . . . . . . . . . . 2:6
Treatment overview group . 3:8

U
UF rate alarm . . . . . . . . . . 3:17
UF volume . . . . . . . . . . . . 3:26

AK 95 S Operators manual - Index

UF volume alarm . . . . . . . 3:17


Ultra Filtered Dialysis Fluid 1:9
Ultra Filtered Dialysis Fluid kit
(Option) . . . . . . . . . . . . . . . 2:4
Ultrafiltration path . . . . . . . 3:8

V
Venous blood line . . . . . . . 4:10
Venous pressure . . . . . . . . 3:25
Venous pressure alarm . . . 3:16

Venous pressure transducer


connector . . . . . . . . . . . . . . 2:3
Viewing Angle Adjustment 3:21
Volume control button . . . . . 3:7

W
Warning . . . . . . . . . . . . . . . .
Water inlet . . . . . . . . . . . . . .
Water requirements . . . . . . .
Wheels . . . . . . . . . . . . . . . . .

AK 95 S Operators manual - Index

1:2
2:8
1:8
2:6

HCEN9794 Revision.08.2003
Program version 10.xx

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