Gambro AK 98 User manual

AK 98 Dialysis Machine
Operator’s Manual
Program version 2.xx
Order number:
MHCEN12745-10/16

HCEN12745 Revision 10.2016
Program version 2.xx
Trademarks
AK 98, BiCart, CleanCart, Diascan, Evodial, Gambro, Polyflux, Revaclear, SoftPac and U9000 are
trademarks of Baxter International Inc. or its subsidiaries.
Dialox is a trademark of Bioxal.
Hastelloy is a trademark of Haynes International Inc.
Manufacturer
Gambro Lundia AB
Box 10101 Magistratsvägen 16
SE-220 10 LUND
Sweden
Phone [phone]
www.baxter.com
Questions or comments about this publication can be directed to your local representative or to the
manufacturer.

HCEN12745 Revision 10.2016
Program version 2.xx
Operators handbook
1
Before you get started ......................................................................................................... A:9
2
Machine Description .......................................................................................................... A:27
3
Handling the dialysis machine .......................................................................................... A:51
4
Haemodialysis - Double needle treatment .......................................................................A:75
5
Haemodialysis - Single needle treatment ......................................................................A:105
6
Isolated ultrafiltration....................................................................................................... A:113
7
Profiling ............................................................................................................................. A:117
8
Measuring blood pressure .............................................................................................. A:127
9
DIASCAN ........................................................................................................................... A:135
10
Disinfection and cleaning ................................................................................................ A:143
11
Disinfection with the AK 98 dialysis machine and WRO system.................................A:159
12
IT Connectivity.................................................................................................................. A:165
13
Maintenance handling...................................................................................................... A:171
14
Technical data and specifications .................................................................................. A:177
15
Local regulatory registration (if applicable) .................................................................. A:195
Alarm handbook
1
Alarms ................................................................................................................................... B:9
2
Attentions............................................................................................................................ B:69

HCEN12745 Revision 10.2016
Program version 2.xx
Table of contents
1
Before you get started ......................................................................................................... A:9
1.1
Important while reading the operator’s manual ................................................... A:10
1.1.1
About this operator´s manual ............................................................................... A:10
1.1.2
Safety definitions .................................................................................................. A:10
1.1.3
Values and settings .............................................................................................. A:10
1.1.4
Buttons ................................................................................................................. A:10
1.1.5
About the screen .................................................................................................. A:11
1.1.6
Symbols................................................................................................................ A:12
1.2
General warning and precautions before use ...................................................... A:15
1.2.1
General precautions before use ........................................................................... A:15
1.2.2
Responsibility and disclaimer ............................................................................... A:17
1.2.3
Leakage current and potential equalisation connection .......................................A:18
1.2.4
Treatment location ................................................................................................ A:18
1.2.5
Central venous catheter ....................................................................................... A:18
1.2.6
Connection of external electrical equipment.........................................................A:18
1.2.7
How to move the AK 98 dialysis machine ............................................................A:18
1.2.8
Safety philosophy ................................................................................................. A:19
1.3
Intended use ............................................................................................................ A:19
1.3.1
Intended use......................................................................................................... A:19
1.3.2
Training................................................................................................................. A:20
1.3.3
Disinfection and functional check ......................................................................... A:20
1.3.4
Inlet water requirements ....................................................................................... A:21
1.3.5
Hygienic quality of central delivery systems .........................................................A:21
1.3.6
Preparing dialysis fluid.......................................................................................... A:21
1.4
Accessories ............................................................................................................. A:21
1.4.1
Concentrates, chemical disinfectants, accessories and disposables ...................A:21
1.4.2
Concentrates ........................................................................................................ A:22
1.4.3
Chemical disinfectants.......................................................................................... A:22
1.4.4
Blood lines ............................................................................................................ A:23
1.4.5
Accessories .......................................................................................................... A:23
1.4.6
Ultrafilter ............................................................................................................... A:24
1.4.7
Dialyzers............................................................................................................... A:24
1.4.8
Blood pressure measurement accessories ..........................................................A:24
1.5
Glossary ................................................................................................................... A:25
1.5.1
Glossary ............................................................................................................... A:25
2
Machine Description .......................................................................................................... A:27
2.1
Blood part................................................................................................................. A:28
2.1.1
Blood part components......................................................................................... A:28
2.1.2
Blood part component details ............................................................................... A:29
2.2
Fluid part .................................................................................................................. A:36
2.2.1
Fluid part components .......................................................................................... A:36
2.2.2
Fluid part component details ................................................................................ A:37

HCEN12745 Revision 10.2016
Program version 2.xx
2.3
Rear component ...................................................................................................... A:44
2.3.1
Rear components ................................................................................................. A:44
2.3.2
Rear component details........................................................................................ A:45
3
Handling the dialysis machine .......................................................................................... A:51
3.1
Operator's position.................................................................................................. A:53
3.1.1
Operator's position ............................................................................................... A:53
3.2
Switch the dialysis machine on and off ................................................................ A:53
3.2.1
Main switch........................................................................................................... A:53
3.2.2
On/off button......................................................................................................... A:53
3.3
Indication light and buttons ................................................................................... A:54
3.3.1
Indication light....................................................................................................... A:54
3.3.2
Buttons on the operator´s panel ........................................................................... A:54
3.4
The screen................................................................................................................ A:55
3.4.1
Screen overview ................................................................................................... A:55
3.4.2
Venous and arterial pressure controls (1, 2).........................................................A:56
3.4.3
Machine state indicator (3) ................................................................................... A:57
3.4.4
Time (4) ................................................................................................................ A:57
3.4.5
Blood path (5) ....................................................................................................... A:57
3.4.6
Fluid path (6) ........................................................................................................ A:58
3.4.7
Bypass path.......................................................................................................... A:58
3.4.8
Blood pressure area (7, 8).................................................................................... A:58
3.4.9
Diascan read out field and Diascan button (9, 10) ...............................................A:58
3.4.10
Treatment overview (11–15) ................................................................................. A:58
3.4.11
Alarm tab (16)....................................................................................................... A:59
3.4.12
Information tab (17) .............................................................................................. A:59
3.4.13
Treatment graph tab (18)...................................................................................... A:59
3.4.14
Information field (19)............................................................................................. A:59
3.4.15
Patient page (20) .................................................................................................. A:60
3.4.16
Priming button (21) ............................................................................................... A:60
3.4.17
Rinse back button (22) ......................................................................................... A:60
3.4.18
Disinfection button (23)......................................................................................... A:61
3.4.19
Blood button (24) .................................................................................................. A:62
3.4.20
Fluid button (25) ................................................................................................... A:64
3.4.21
Fluid bypass button (26) ....................................................................................... A:66
3.4.22
Ultrafiltration button (27) ....................................................................................... A:66
3.4.23
Treatment history page (28) ................................................................................. A:66
3.4.24
Status bar (29)...................................................................................................... A:68
3.4.25
Service menu........................................................................................................ A:68
3.5
Concentrate standby mode .................................................................................... A:70
3.5.1
About concentrate standby mode.........................................................................A:70
3.5.2
To manually activate concentrate standby mode..................................................A:70
3.5.3
To resume preparation of dialysis fluid .................................................................A:70
3.5.4
To automatically enter concentrate standby mode ...............................................A:71

HCEN12745 Revision 10.2016
Program version 2.xx
3.6
Operate the machine during power failure ........................................................... A:71
3.6.1
Power failure with battery back-up ....................................................................... A:71
3.6.2
Power failure without battery back-up .................................................................. A:71
3.6.3
Return the blood to the patient manually..............................................................A:71
3.7
Change of dialyzer and blood lines during treatment.......................................... A:72
3.8
Change of BICART cartridge during Treatment.................................................... A:73
3.9
The ultrafiltration control........................................................................................ A:73
4
Haemodialysis - Double needle treatment .......................................................................A:75
4.1
Basic functionality................................................................................................... A:76
4.2
Start a double needle treatment ............................................................................ A:76
4.2.1
Check before treatment ........................................................................................ A:76
4.2.2
Start functional check ........................................................................................... A:76
4.2.3
Set up the dialysis machine.................................................................................. A:77
4.2.4
Attach the arterial blood line ................................................................................. A:79
4.2.5
Attach the venous blood line ................................................................................ A:84
4.2.6
Attach the heparin syringe.................................................................................... A:89
4.2.7
Priming the dialysis circuit .................................................................................... A:91
4.2.7.1
Priming description ...........................................................................................A:91
4.2.7.2
Manual priming .................................................................................................A:91
4.2.7.3
Assisted priming ...............................................................................................A:93
4.2.8
Priming options..................................................................................................... A:94
4.2.8.1
Extra priming ....................................................................................................A:94
4.2.8.2
Recirculation..................................................................................................... A:94
4.2.9
Set treatment time ................................................................................................ A:95
4.2.10
Set ultrafiltration volume ....................................................................................... A:95
4.2.11
Set heparin values................................................................................................ A:96
4.2.12
Connect the patient .............................................................................................. A:97
4.2.13
Start the treatment................................................................................................ A:99
4.3
End a double needle treatment ............................................................................ A:100
4.3.1
End the treatment ............................................................................................... A:100
4.3.2
Confirm disconnect patient ................................................................................A:101
4.3.3
Machine aftercare............................................................................................... A:101
5
Haemodialysis - Single needle treatment ......................................................................A:105
5.1
Basic functionality................................................................................................. A:106
5.2
Preparations........................................................................................................... A:106
5.3
Connect the patient ............................................................................................... A:109
5.4
Start the treatment..................................................................................................A:110
5.5
End a single needle treatment...............................................................................A:112

HCEN12745 Revision 10.2016
Program version 2.xx
6
Isolated ultrafiltration....................................................................................................... A:113
6.1
Basic functionality..................................................................................................A:114
6.2
Handling isolated ultrafiltration ............................................................................A:114
6.2.1
Activate isolated ultrafiltration............................................................................. A:114
6.2.2
How to add a second and subsequent phase of isolated UF ............................. A:115
6.2.3
Deactivate isolated ultrafiltration......................................................................... A:115
6.3
Additional information ...........................................................................................A:115
6.3.1
Heparin ............................................................................................................... A:115
7
Profiling ............................................................................................................................. A:117
7.1
General .................................................................................................................... A:118
7.2
Profiling of sodium and bicarbonate concentrations .........................................A:118
7.3
Profiling of ultrafiltration rate................................................................................A:119
7.4
Profiling setting/activation ................................................................................... A:122
7.5
Profiling without a preset model.......................................................................... A:122
7.5.1
Profiling ultrafiltration without a preset model.....................................................A:122
7.5.2
Profiling sodium without a preset model.............................................................A:123
7.5.3
Profiling bicarbonate without a preset model......................................................A:124
7.6
Set and activate profiling with a preset model ................................................... A:125
8
Measuring blood pressure .............................................................................................. A:127
8.1
Blood pressure monitor (BPM) ............................................................................ A:128
8.2
Blood pressure cuff............................................................................................... A:128
8.3
Direct blood pressure measuring ........................................................................ A:130
8.4
Interval blood pressure measuring...................................................................... A:130
8.5
Measurement history ............................................................................................ A:131
8.6
Set alarm limits ...................................................................................................... A:131
8.7
Patient care during blood pressure measuring.................................................. A:132
8.7.1
All patients .......................................................................................................... A:132
8.7.2
Patients with high blood pressure....................................................................... A:133
8.7.3
Patients with arrhythmia ..................................................................................... A:134
9
DIASCAN ........................................................................................................................... A:135
9.1
How DIASCAN function works ............................................................................. A:136
9.2
What DIASCAN function checks .......................................................................... A:136
9.3
Check K and Kt ...................................................................................................... A:136
9.4
Check Kt/V.............................................................................................................. A:137
9.5
Measurement history ............................................................................................ A:138
9.6
Set a Kt/V target value........................................................................................... A:139

HCEN12745 Revision 10.2016
Program version 2.xx
9.7
Set an alarm for low K or Kt/V .............................................................................. A:140
9.8
Factors that affect measuring .............................................................................. A:140
10
Disinfection and cleaning ................................................................................................ A:143
10.1
Disinfection and cleaning – general .................................................................... A:144
10.2
Check before you start.......................................................................................... A:144
10.3
Heat disinfection.................................................................................................... A:145
10.3.1
Description of heat disinfection........................................................................... A:145
10.3.2
Cleaning and decalcification............................................................................... A:145
10.3.3
Start a heat disinfection ...................................................................................... A:146
10.3.4
Start a heat disinfection with a CLEANCART cartridge......................................A:146
10.3.5
Start a heat disinfection with liquid citric acid .....................................................A:146
10.3.6
Start a short heat disinfection with liquid citric acid ............................................A:147
10.3.7
Integrated heat disinfection ................................................................................ A:147
10.3.7.1
Integrated heat disinfection ............................................................................A:147
10.3.7.2
To schedule a heat disinfection program ........................................................A:147
10.3.7.3
To turn off a scheduled program.....................................................................A:148
10.3.8
Integrated heat disinfection with a WRO 300 H unit...........................................A:149
10.3.8.1
Integrated heat disinfection with a WRO 300 H unit.......................................A:149
10.4
Chemical disinfection ........................................................................................... A:149
10.4.1
About chemical disinfection ................................................................................ A:149
10.4.2
Start a chemical disinfection............................................................................... A:149
10.4.3
Start a central chemical disinfection ...................................................................A:150
10.4.4
Chemical disinfection program with a WRO unit ................................................A:151
10.4.5
Test for disinfectant residues ..............................................................................A:151
10.4.6
Disinfection history ............................................................................................. A:152
10.4.7
About chemical disinfectants .............................................................................. A:152
10.5
Rinse and Drain ..................................................................................................... A:153
10.5.1
Start rinse or drain .............................................................................................. A:153
10.5.2
To schedule a rinse program ..............................................................................A:153
10.5.3
To turn off rinse program for a certain day..........................................................A:154
10.6
Machine storage with chemical disinfectant ...................................................... A:154
10.6.1
Fill the dialysis machine with chemical disinfectant............................................A:154
10.6.2
Start using a dialysis machine filled with chemical disinfectant..........................A:155
10.7
Reference ............................................................................................................... A:156
10.7.1
Disinfection, Decalcification and Cleaning Agents - Characteristics ..................A:156
10.7.2
Cleaning and disinfection schedule ....................................................................A:156
10.7.3
Flow path ............................................................................................................ A:157
11
Disinfection with the AK 98 dialysis machine and WRO system.................................A:159
11.1
General description............................................................................................... A:160
11.2
Integrated heat disinfection with a WRO 300 H unit .......................................... A:160
11.2.1
Description of integrated heat disinfection with a WRO 300 H unit ....................A:160
11.2.2
Schedule an integrated heat disinfection............................................................A:160
11.2.3
Start an integrated heat disinfection manually....................................................A:160

HCEN12745 Revision 10.2016
Program version 2.xx
11.3
Central chemical disinfection program with a WRO unit .................................. A:161
11.3.1
Description of central chemical disinfection program with a WRO unit ..............A:161
11.3.2
Start a central chemical disinfection with a WRO unit ........................................A:161
11.4
Settings for rinse ................................................................................................... A:163
11.4.1
Rinse settings ..................................................................................................... A:163
12
IT Connectivity.................................................................................................................. A:165
12.1
Basic functionality................................................................................................. A:166
12.2 Confirmed Patient ID and retrieval of patient prescription when the Patient ID
is confirmed ....................................................................................................... A:166
12.3
Cancel prescription retrieval ................................................................................ A:168
12.4
Clearing Patient ID and patient prescription....................................................... A:168
12.5
Setting treatment parameters manually .............................................................. A:169
12.6
Setting Station ID................................................................................................... A:169
12.7
Unconfirmed patient with data transfer only ...................................................... A:170
13
Maintenance handling...................................................................................................... A:171
13.1
Maintenance........................................................................................................... A:172
13.2
Blood Pump Rotor................................................................................................. A:172
13.2.1
Maintenence of the blood pump rotor.................................................................A:172
13.2.2
Clean the blood pump rotor ................................................................................ A:172
13.3
Clean the blood leak detector .............................................................................. A:173
13.4
Water inlet tube...................................................................................................... A:173
13.5
Pick-up tubes ......................................................................................................... A:173
13.6
Surface ................................................................................................................... A:174
13.7
Change ultrafilter................................................................................................... A:174
13.8
Storage ................................................................................................................... A:175
13.9
Service.................................................................................................................... A:175
13.10
Disposal.................................................................................................................. A:176
14
Technical data and specifications .................................................................................. A:177
14.1
Performance and specification - Control System .............................................. A:178
14.1.1
Blood flow control ............................................................................................... A:178
14.1.2
Heparin pump ..................................................................................................... A:178
14.1.3
Blood pressure ................................................................................................... A:178
14.1.4
Blood pressure monitor (BPM) ........................................................................... A:178
14.1.5
Dialysis fluid preparation .................................................................................... A:179
14.1.6
Ultrafiltration control............................................................................................ A:180
14.1.7
Ultrafiltration protective....................................................................................... A:180
14.1.8
Profiling............................................................................................................... A:180
14.1.9
DIASCAN function .............................................................................................. A:180
14.1.10
Disinfection and cleaning – chemical disinfection ..............................................A:180

HCEN12745 Revision 10.2016
Program version 2.xx
14.1.11
Disinfection and cleaning - heat disinfection ......................................................A:181
14.1.12
Auto heat disinfection ......................................................................................... A:182
14.1.13
Heat disinfection program including WRO 300 H ...............................................A:182
14.1.14
Disinfection and cleaning – rinse/drain...............................................................A:182
14.1.15
Disinfection and cleaning – exterior cleaning .....................................................A:183
14.1.16
Water supply....................................................................................................... A:183
14.1.17
Power supply ...................................................................................................... A:183
14.1.18
Network connection ............................................................................................ A:184
14.1.19
Connection of external equipment......................................................................A:184
14.1.20
Battery back-up .................................................................................................. A:185
14.2
Performance and specification - Supervisory system....................................... A:185
14.2.1
Blood pressure supervision ................................................................................ A:185
14.2.2
Air detection........................................................................................................ A:185
14.2.3
Extracorporeal blood loss due to coagulation.....................................................A:186
14.2.4
Dialysis fluid preparation .................................................................................... A:186
14.2.5
TMP .................................................................................................................... A:186
14.2.6
Blood leakage detection ..................................................................................... A:186
14.3
Alarm sound pressure .......................................................................................... A:186
14.3.1
Alarm sound pressure ........................................................................................ A:186
14.4
Physical data.......................................................................................................... A:186
14.4.1
Dimensions and weight ...................................................................................... A:186
14.4.2
Infusion stand ..................................................................................................... A:187
14.5
Materials in contact with dialysis fluid, concentrates, and water .................... A:187
14.5.1
Polymers............................................................................................................. A:187
14.5.2
Metals ................................................................................................................. A:187
14.5.3
Other materials ................................................................................................... A:187
14.6
Environmental data ............................................................................................... A:188
14.6.1
Operation............................................................................................................ A:188
14.6.2
Transportation and storage ................................................................................ A:188
14.6.3
Electromagnetic environment .............................................................................A:188
14.6.4
Expected service life........................................................................................... A:191
14.6.5
Energy and water consumption ..........................................................................A:192
14.7
Standards ............................................................................................................... A:192
15
Local regulatory registration (if applicable) .................................................................. A:195

HCEN12745 Revision 10.2016
Program version 2.xx AK 98 Dialysis Machine - Before you get started A:9
1 Before you get started
1.1
Important while reading the operator’s manual ................................................... A:10
1.1.1
About this operator´s manual ............................................................................... A:10
1.1.2
Safety definitions .................................................................................................. A:10
1.1.3
Values and settings .............................................................................................. A:10
1.1.4
Buttons ................................................................................................................. A:10
1.1.5
About the screen .................................................................................................. A:11
1.1.6
Symbols................................................................................................................ A:12
1.2
General warning and precautions before use ...................................................... A:15
1.2.1
General precautions before use ........................................................................... A:15
1.2.2
Responsibility and disclaimer ............................................................................... A:17
1.2.3
Leakage current and potential equalisation connection .......................................A:18
1.2.4
Treatment location ................................................................................................ A:18
1.2.5
Central venous catheter ....................................................................................... A:18
1.2.6
Connection of external electrical equipment.........................................................A:18
1.2.7
How to move the AK 98 dialysis machine ............................................................A:18
1.2.8
Safety philosophy ................................................................................................. A:19
1.3
Intended use ............................................................................................................ A:19
1.3.1
Intended use......................................................................................................... A:19
1.3.2
Training................................................................................................................. A:20
1.3.3
Disinfection and functional check ......................................................................... A:20
1.3.4
Inlet water requirements ....................................................................................... A:21
1.3.5
Hygienic quality of central delivery systems .........................................................A:21
1.3.6
Preparing dialysis fluid.......................................................................................... A:21
1.4
Accessories ............................................................................................................. A:21
1.4.1
Concentrates, chemical disinfectants, accessories and disposables ...................A:21
1.4.2
Concentrates ........................................................................................................ A:22
1.4.3
Chemical disinfectants.......................................................................................... A:22
1.4.4
Blood lines ............................................................................................................ A:23
1.4.5
Accessories .......................................................................................................... A:23
1.4.6
Ultrafilter ............................................................................................................... A:24
1.4.7
Dialyzers............................................................................................................... A:24
1.4.8
Blood pressure measurement accessories ..........................................................A:24
1.5
Glossary ................................................................................................................... A:25
1.5.1
Glossary ............................................................................................................... A:25

A:10 AK 98 Dialysis Machine - Before you get started HCEN12745 Revision 10.2016
Program version 2.xx
1.1 Important while reading the operator’s manual
1.1.1 About this operator´s manual
This operator’s manual provides instructions necessary for the proper operation of the
AK 98 dialysis machine. It is not a guide for the administration of haemodialysis.
1.1.2 Safety definitions
Warning
WARNING!
A warning alerts the reader about a situation which, if not avoided, could result in an
adverse reaction, injury or death.
Caution
CAUTION!
A caution alerts the reader about a situation which, if not avoided, could result in
minor or moderate injury to the user or patient or damage to the equipment or other
property.
Note
NOTE!
Notes are added to give more information.
1.1.3 Values and settings
Parameter values are set by the operator. For example treatment time and some alarm
limits. See Section 1.1.5 “About the screen” on pageA:11. All values and settings in
this operator’s manual are default values, which are set when the dialysis machine is
manufactured. Check with the authorised service technician responsible for installing
the dialysis machine if there are any values that are changed from the default settings.
Preset
When this symbol appears in the manual text, it indicates the possibility to preset
the value of a parameter. Such a preset is done to adapt the settings of the machine to
correspond with the routines of the user/clinic or specific patient prescription. A preset
change shall always be done by an authorised service technician. For example, it is
possible to preset the machine for which mode to start up in, some alarm limits, some
functions and options. An authorised service technician shall, together with the user,
confirm that the presets have been properly set.
1.1.4 Buttons
The buttons on the operator's panel, to the right of the screen, light up in different
situations to guide the operator or to inform of actual status. See Figure 1-1 “The
operator´s panel” on pageA:11. The illustrations in the handling instructions do not
normally show if the button is lit or unlit; the button figures are the same for lit, flashing
and unlit buttons.
The buttons on the screen can be lit, disabled or flashing depending on the status and
action but in this manual this state of the button is not reflected in the text or picture.

HCEN12745 Revision 10.2016
Program version 2.xx AK 98 Dialysis Machine - Before you get started A:11
1.1.5 About the screen
The operator´s panel of the AK 98 dialysis machine has a colour touch screen. The
screen allows the operator to interact with the dialysis machine by pressing various
buttons.
Figure 1-1. The operator´s panel
Press a button or menu item to activate its function.
Select a tab to reach the settings. The UF rate tab is selected in this picture.
Press a setting to adjust it. For example UF volume.
Use the keypad to adjust numeric values. The keypad will open automatically when
needed.

A:12 AK 98 Dialysis Machine - Before you get started HCEN12745 Revision 10.2016
Program version 2.xx
1.1.6 Symbols
The symbols can be affixed to the machine or affixed/printed on the original packaging.
Alternating current
Protective earth (ground)
Off (disconnection from the mains power)
On (connection to the mains power)
Equipotential connector
The AK 98 dialysis machine is protected against solid foreign objects ≥12.5 mm Ø and
vertically falling water drops.
Type B, applied part
NIBP type BF applied part
The product does not contain latex. The symbol frame and text are white.
The product does not contain PVC. The symbol frame and text are white.
The maximum stacking load permitted on the transport package
Fragile – Handle with care
This way up
Keep dry

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Program version 2.xx AK 98 Dialysis Machine - Before you get started A:13
Catalogue number
Serial number
Humidity limitation. Upper and lower limit is expressed with numeric values in %.
Atmospheric pressure limitation. Upper and lower limit is expressed with numeric
values in kPa.
Temperature limitation. Upper and lower limit is expressed with numeric values in
degree Celsius or Fahrenheit.
Manufacturer. The date of manufacture as well as the name and address of the
manufacturer are included in the symbol.
Recycling symbol – Corrugated Cardboard. According to GB 18455–2001.
This symbol indicates that the dialysis machine contains toxic or hazardous
substances or elements according to GB/T26572-2011. The number 25 indicates the
corresponding environmental protection use period of the dialysis machine.
Separate collection for electrical and electronic equipment
Warning, dangerous voltage. Contact may cause electric shock or burn. The symbol
colour is black on a yellow background.
Warning. Do not lean the AK 98 dialysis machine more than 5° from the horizontal
plane. The symbol colour is black on a yellow background.
Do not lean or push the AK 98 dialysis machine. Risk for overbalance. The symbol
colours are red, white, and black.
The weight of the AK 98 dialysis machine including equipment used for the treatment
placed on the machine.
Caution, consult accompanying documents
Read instructions before use. The symbol colour is white on a blue background.
The following symbols are found on the cuff:
Index Line
Artery symbol and arrow should be placed over brachial or femoral artery.
Symbol indicating arm circumference.
Cuff index line must fall within range markings.
The following symbols are found on the BICART cartridge holder:

A:14 AK 98 Dialysis Machine - Before you get started HCEN12745 Revision 10.2016
Program version 2.xx
Shows where the top port of the BICART and CLEANCART cartridges connects with
the upper arm during cartridge installation.
A guide to ensure the correct upright positioning of the BICART and CLEANCART
cartridges during its installation.
Cuff ranges/colours
Number: Size: Colour: Range:
1 Thigh Brown 38-50 cm
2 Lg Adult Long Burgundy 31-40 cm
3 Lg Adult Burgundy 31-40 cm
4 Adult Long Navy Blue 23-33 cm
5 Adult Navy Blue 23-33 cm
6 Sm Adult Long Royal Blue 17-25 cm
7 Sm Adult Royal Blue 17-25 cm
8 Child Long Green 12-19 cm
9 Child Green 12-19 cm
10 Infant Orange 8-13 cm
Table 1-1. Cuff ranges/colours
Certification marks
CE marking
The CE conformity mark indicates that the AK 98 dialysis
machine conforms to the requirements in the EC Council
Directive 93/42/EEC of 14 June, 1993 concerning medical
devices. It also indicates that the notified body British Standards
Institution (BSI, No. 0086) has approved the Quality
Management System. The CE conformity mark is only valid for
the AK 98 dialysis machine. Disposables and any accessories
specified for use with the AK 98 dialysis machine are marked
with CE conformity marks in their own right.
CSA marking
The CSA mark indicates that the AK 98 dialysis machine
conforms to the requirements related to safety of medical
devices for Canada and that the AK 98 dialysis machine has
been evaluated to the applicable CSA standards for use in
Canada.

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1.2 General warning and precautions before use
1.2.1 General precautions before use
WARNING!
Unauthorised modifications, alterations or repair and lack of maintenance or
calibration of the AK 98 dialysis machine may result in malfunctioning or have other
serious consequences for the safe operation of the equipment.
WARNING!
The mains power cable from the AK 98 dialysis machine (cable length is 3.5 metres)
shall be connected to a socket with protected earth (PE) to avoid risk of electrical
shock.
WARNING!
To minimise the risk of arrhythmia due to leakage currents when a central venous
catheter is used, and the tip of the catheter is close to the heart, it is necessary to
connect the potential equalisation conductor between the AK 98 dialysis machine
and the potential equalisation busbar in the electrical installation.
WARNING!
To minimise the risk of arrhythmia due to leakage currents from other electrical
equipment when a central venous catheter is used, and the tip of the catheter is
close to the heart, any equipment within the patient area shall have leakage current
values below respective limit required by CF type applied parts.
WARNING!
To protect the children, never leave children unattended near the dialysis machine,
its chemicals, disposables or accessories.
WARNING!
To avoid the risk of electric shock, this equipment must only be connected to a
supply mains with protective earth.
WARNING!
Never use multiple socket-outlet when connecting the dialysis machine or WRO 300
to mains supply since it might lead to too high leakage currents during fault
conditions.
WARNING!
Do not use the AK 98 dialysis machine adjacent to or stacked with other equipment,
other than specified by the manufacturer.
WARNING!
Use of accessories, transducers and cables other than those specified or provided
by the manufacturer of this equipment could result in increased electromagnetic
emissions or decreased electromagnetic immunity of this equipment and result in
improper operation.
WARNING!
Portable RF communications equipment (including peripherals such as antenna
cables and external antennas) shall not be used no closer than 30 cm (12 inches) to
any part of the ME EQUIPMENT, including cables specified by the manufacturer.
Otherwise, degradation of the performance of this equipment could be the result.

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CAUTION!
To avoid improper handling, the AK 98 dialysis machine may only be operated by
persons trained in haemodialysis 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 1.2.8 “Safety philosophy” on
pageA:19. Verify that the first digit of the program version of both the machine
and the manual is the same. If the AK 98 dialysis machine does not perform as
described in this manual, it should not be used until the condition is rectified.
CAUTION!
When unpacking, check the equipment for any signs of damage. If the equipment is
in any way damaged, proper operation cannot be assured.
CAUTION!
Patients connected to the AK 98 dialysis machine should be monitored by
competent personnel since life threatening situations can arise that may not activate
alarms. The operator should pay attention to all appropriate alarms and follow the
instructions, warnings, cautions, and notes given in this manual. It is imperative that
the machine has passed the functional check before connecting a patient.
CAUTION!
To ensure proper functionality, all calibration checks must be completed during
installation before the machine is used for dialysis treatment.
CAUTION!
The AK 98 dialysis machine needs special precautions regarding EMC and needs to
be installed and put into service according to the EMC information in Section 14.6.3
“Electromagnetic environment” on pageA:188.
CAUTION!
The use of mobile telephones or communication equipment in the vicinity of the
AK 98 dialysis machine could adversely influence the performance of the machine.
For further information, see Section 14 “Technical data and specifications” on
pageA:177.
CAUTION!
The AK 98 dialysis machine will perform as designed only if it is used and
maintained in accordance with Baxter’s instructions. Any warranties made by Baxter
with respect to the AK 98 dialysis machine are void if the equipment is not used in
accordance with the instructions provided. Baxter will not accept responsibility for
any damage or injury resulting from improper use or maintenance or unauthorised
repair.
CAUTION!
To ensure proper functionality preventive inspection, maintenance and calibration of
the AK 98 dialysis machine shall be performed by a fully trained authorised service
technician according to the maintenance manual in the AK 98 Service manual which
can be ordered from your Baxter representative. It is mandatory for preventive
maintenance to be performed at least every other year. Yearly maintenance is
recommended. The interval between preventive maintenance procedures might
differ due to operating environment variations.
CAUTION!
Check the use environment before use as the AK 98 dialysis machine is not suitable
for use in the presence of a flammable anaesthetic mixture with air or with oxygen or
nitrous oxide.

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CAUTION!
Make sure that any used chemical disinfectants are stored according to
manufacturer’s recommendations.
CAUTION!
Make sure not to position the AK 98 dialysis machine in a way that it becomes
difficult to operate the mains power switch.
NOTE!
The AK 98 dialysis machine must be installed according to the Installation guide.
NOTE!
For accuracy ranges written as ”(±1 mL/min or ±1%)”, the widest range is valid.
NOTE!
It is recommended that the equipment is kept in its original packing during
transportation and storage.
NOTE!
The service manual is only available for the authorised service technician.
NOTE!
It is important that the protective earth in the installation is of high quality.
NOTE!
For the purpose of protecting the environment the AK 98 dialysis machine shall be
separately collected for dismantling and recovery. Where applicable, national
regulations shall be applied. Consult your local Baxter distributor for information.
NOTE!
To protect the machine against spillage, the infusion stand must always be correctly
mounted in the machine.
NOTE!
The WRO unit (WRO 300 or WRO 300 H) must be preset by an authorised service
technician to work correctly with the dialysis machine.
1.2.2 Responsibility and disclaimer
The manufacturer accepts responsibility for the safety, reliability, and performance of
this equipment only if the following conditions are fulfilled:
●Installation, operational procedures, maintenance, calibrations and repairs are
carried out by appropriately trained and suitable qualified people.
●All equipment modifications are authorised in writing by the manufacturer and
carried out by appropriately trained and suitable qualified people.
●The electrical installation of the relevant room complies with all applicable local
electrical codes and, if applicable, IEC requirements.
●The equipment is used in accordance with the published operator’s manual.
Baxter does not accept any responsibility or liability for use of accessories or
disposables other than those specified in this manual or if any specified accessory or
disposable is not used in accordance with this manual, online instructions and the
instructions for use accompanying those accessories and disposables.
The patient’s physician is responsible for counselling, home care follow-up and
medical maintenance that comes with the treatment. Baxter has no responsibility for
any of these activities.

A:18 AK 98 Dialysis Machine - Before you get started HCEN12745 Revision 10.2016
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1.2.3 Leakage current and potential equalisation connection
Definitions
Leakage current Electrical current that leaks out of the intended circuit
or current that is not functional.
Potential equalisation connection A connection between the potential equalisation
connector of the machine and the potential
equalisation busbar of the electrical installation using
a potential equalisation conductor. This connection
shall be additional to the protective earth connection.
1.2.4 Treatment location
The user must make sure that the location where the AK 98 dialysis machine is
installed, including the patient environment, is suitable for dialysis treatment. The
location shall be maintained at a hygienic standard suitable for dialysis treatment and
kept free from pets and pests.
The dialysis treatment shall not be performed in proximity to high-powered ME
EQUIPMENT.
Any other electrical equipment used in the patient environment shall be marked with:
Any other electrical equipment not having this mark shall be located outside the patient
environment. A potential equalisation connection has to be used when it is legally
required.
1.2.5 Central venous catheter
If a central venous catheter is used during treatment with the tip of the catheter close
to the heart a potential equalisation connection must be used.
1.2.6 Connection of external electrical equipment
The AK 98 dialysis machine is equipped with three interface contacts on the back side;
a 25 pole D-Sub, a USB and an Ethernet connector. These connectors shall only be
used by an authorised service technician. All other use is prohibited.
1.2.7 How to move the AK 98 dialysis machine
Always use the transportation handle when moving the dialysis machine. Take a firm
hold on the transportation handle and gently pull the device over a step, do not push.
Make sure the brakes are released before moving the dialysis machine.
WARNING!
If a remote Operator's Panel has been installed, fluid bags shall be removed from
the infusion stand when transporting (moving) the machine to avoid overbalance.
The fluid bags may be placed on the top tray.
CAUTION!
Do not move the dialysis machine during a treatment. If you need to move the
dialysis machine to reach the side only do small adjustments and make sure not to
overbalance or collide the dialysis machine as this could damage the equipment.