Gambro AK-98 User manual
AK 98 Dialysis Machine
Operator’s Manual
Program version 2.xx
Order number:
MHCEN12745-10/16
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 +46 46 169000
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
Before you get started .........................................................................................................A:9
Machine Description ..........................................................................................................A:27
Handling the dialysis machine .......................................................................................... A:51
Haemodialysis - Double needle treatment ....................................................................... A:75
Haemodialysis - Single needle treatment ......................................................................A:105
Isolated ultrafiltration....................................................................................................... A:113
Profiling ............................................................................................................................. A:117
Measuring blood pressure .............................................................................................. A:127
DIASCAN ........................................................................................................................... A:135
Disinfection and cleaning ................................................................................................ A:143
Disinfection with the AK 98 dialysis machine and WRO system.................................A:159
IT Connectivity.................................................................................................................. A:165
Maintenance handling...................................................................................................... A:171
Technical data and specifications .................................................................................. A:177
Local regulatory registration (if applicable) .................................................................. A:195
Alarms ................................................................................................................................... B:9
Attentions............................................................................................................................ B:69
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
Alarm handbook
1
2
HCEN12745 Revision 10.2016
Program version 2.xx
Table of contents
Before you get started ......................................................................................................... A:9
Important while reading the operator’s manual ................................................... A:10
About this operator´s manual ...............................................................................A:10
Safety definitions .................................................................................................. A:10
Values and settings .............................................................................................. A:10
Buttons .................................................................................................................A:10
About the screen .................................................................................................. A:11
Symbols................................................................................................................ A:12
General warning and precautions before use ...................................................... A:15
General precautions before use ........................................................................... A:15
Responsibility and disclaimer ............................................................................... A:17
Leakage current and potential equalisation connection .......................................A:18
Treatment location................................................................................................ A:18
Central venous catheter .......................................................................................A:18
Connection of external electrical equipment......................................................... A:18
How to move the AK 98 dialysis machine ............................................................A:18
Safety philosophy ................................................................................................. A:19
Intended use ............................................................................................................ A:19
Intended use......................................................................................................... A:19
Training................................................................................................................. A:20
Disinfection and functional check ......................................................................... A:20
Inlet water requirements ....................................................................................... A:21
Hygienic quality of central delivery systems ......................................................... A:21
Preparing dialysis fluid.......................................................................................... A:21
Accessories ............................................................................................................. A:21
Concentrates, chemical disinfectants, accessories and disposables ...................A:21
Concentrates ........................................................................................................ A:22
Chemical disinfectants.......................................................................................... A:22
Blood lines ............................................................................................................ A:23
Accessories .......................................................................................................... A:23
Ultrafilter ............................................................................................................... A:24
Dialyzers............................................................................................................... A:24
Blood pressure measurement accessories ..........................................................A:24
Glossary ................................................................................................................... A:25
Glossary ...............................................................................................................A:25
Machine Description ..........................................................................................................A:27
Blood part................................................................................................................. A:28
Blood part components......................................................................................... A:28
Blood part component details ............................................................................... A:29
Fluid part .................................................................................................................. A:36
Fluid part components .......................................................................................... A:36
Fluid part component details ................................................................................A:37
1
1.1
1.1.1
1.1.2
1.1.3
1.1.4
1.1.5
1.1.6
1.2
1.2.1
1.2.2
1.2.3
1.2.4
1.2.5
1.2.6
1.2.7
1.2.8
1.3
1.3.1
1.3.2
1.3.3
1.3.4
1.3.5
1.3.6
1.4
1.4.1
1.4.2
1.4.3
1.4.4
1.4.5
1.4.6
1.4.7
1.4.8
1.5
1.5.1
2
2.1
2.1.1
2.1.2
2.2
2.2.1
2.2.2
HCEN12745 Revision 10.2016
Program version 2.xx
2.3
Rear component ...................................................................................................... A:44
Rear components ................................................................................................. A:44
Rear component details........................................................................................ A:45
Handling the dialysis machine .......................................................................................... A:51
Operator's position.................................................................................................. A:53
Operator's position ............................................................................................... A:53
Switch the dialysis machine on and off ................................................................ A:53
Main switch........................................................................................................... A:53
On/off button......................................................................................................... A:53
Indication light and buttons ................................................................................... A:54
Indication light....................................................................................................... A:54
Buttons on the operator´s panel ........................................................................... A:54
The screen................................................................................................................ A:55
Screen overview ................................................................................................... A:55
Venous and arterial pressure controls (1, 2).........................................................A:56
Machine state indicator (3) ................................................................................... A:57
Time (4) ................................................................................................................ A:57
Blood path (5) ....................................................................................................... A:57
Fluid path (6) ........................................................................................................A:58
Bypass path.......................................................................................................... A:58
Blood pressure area (7, 8)....................................................................................A:58
Diascan read out field and Diascan button (9, 10) ...............................................A:58
Treatment overview (11–15) ................................................................................. A:58
Alarm tab (16)....................................................................................................... A:59
Information tab (17) .............................................................................................. A:59
Treatment graph tab (18)...................................................................................... A:59
Information field (19)............................................................................................. A:59
Patient page (20) .................................................................................................. A:60
Priming button (21) ............................................................................................... A:60
Rinse back button (22) .........................................................................................A:60
Disinfection button (23)......................................................................................... A:61
Blood button (24) .................................................................................................. A:62
Fluid button (25) ...................................................................................................A:64
Fluid bypass button (26) ....................................................................................... A:66
Ultrafiltration button (27) ....................................................................................... A:66
Treatment history page (28) ................................................................................. A:66
Status bar (29)...................................................................................................... A:68
Service menu........................................................................................................ A:68
Concentrate standby mode .................................................................................... A:70
About concentrate standby mode.........................................................................A:70
To manually activate concentrate standby mode..................................................A:70
To resume preparation of dialysis fluid ................................................................. A:70
To automatically enter concentrate standby mode ...............................................A:71
2.3.1
2.3.2
3
3.1
3.1.1
3.2
3.2.1
3.2.2
3.3
3.3.1
3.3.2
3.4
3.4.1
3.4.2
3.4.3
3.4.4
3.4.5
3.4.6
3.4.7
3.4.8
3.4.9
3.4.10
3.4.11
3.4.12
3.4.13
3.4.14
3.4.15
3.4.16
3.4.17
3.4.18
3.4.19
3.4.20
3.4.21
3.4.22
3.4.23
3.4.24
3.4.25
3.5
3.5.1
3.5.2
3.5.3
3.5.4
HCEN12745 Revision 10.2016
Program version 2.xx
3.6
Operate the machine during power failure ........................................................... A:71
Power failure with battery back-up .......................................................................A:71
Power failure without battery back-up ..................................................................A:71
Return the blood to the patient manually..............................................................A:71
Change of dialyzer and blood lines during treatment.......................................... A:72
Change of BICART cartridge during Treatment.................................................... A:73
The ultrafiltration control........................................................................................ A:73
Haemodialysis - Double needle treatment ....................................................................... A:75
Basic functionality................................................................................................... A:76
Start a double needle treatment ............................................................................ A:76
Check before treatment ........................................................................................ A:76
Start functional check ........................................................................................... A:76
Set up the dialysis machine..................................................................................A:77
Attach the arterial blood line ................................................................................. A:79
Attach the venous blood line ................................................................................A:84
Attach the heparin syringe....................................................................................A:89
Priming the dialysis circuit .................................................................................... A:91
Priming description ........................................................................................... A:91
Manual priming ................................................................................................. A:91
Assisted priming ............................................................................................... A:93
Priming options..................................................................................................... A:94
Extra priming ....................................................................................................A:94
Recirculation.....................................................................................................A:94
Set treatment time ................................................................................................ A:95
Set ultrafiltration volume ....................................................................................... A:95
Set heparin values................................................................................................ A:96
Connect the patient ..............................................................................................A:97
Start the treatment................................................................................................ A:99
End a double needle treatment ............................................................................ A:100
End the treatment ............................................................................................... A:100
Confirm disconnect patient ................................................................................ A:101
Machine aftercare...............................................................................................A:101
Haemodialysis - Single needle treatment ......................................................................A:105
Basic functionality................................................................................................. A:106
Preparations........................................................................................................... A:106
Connect the patient ............................................................................................... A:109
Start the treatment.................................................................................................. A:110
End a single needle treatment............................................................................... A:112
3.6.1
3.6.2
3.6.3
3.7
3.8
3.9
4
4.1
4.2
4.2.1
4.2.2
4.2.3
4.2.4
4.2.5
4.2.6
4.2.7
4.2.7.1
4.2.7.2
4.2.7.3
4.2.8
4.2.8.1
4.2.8.2
4.2.9
4.2.10
4.2.11
4.2.12
4.2.13
4.3
4.3.1
4.3.2
4.3.3
5
5.1
5.2
5.3
5.4
5.5
HCEN12745 Revision 10.2016
Program version 2.xx
6
Isolated ultrafiltration....................................................................................................... A:113
Basic functionality.................................................................................................. A:114
Handling isolated ultrafiltration ............................................................................A:114
Activate isolated ultrafiltration............................................................................. A:114
How to add a second and subsequent phase of isolated UF ............................. A:115
Deactivate isolated ultrafiltration......................................................................... A:115
Additional information ........................................................................................... A:115
Heparin ............................................................................................................... A:115
Profiling ............................................................................................................................. A:117
General .................................................................................................................... A:118
Profiling of sodium and bicarbonate concentrations .........................................A:118
Profiling of ultrafiltration rate................................................................................A:119
Profiling setting/activation ................................................................................... A:122
Profiling without a preset model.......................................................................... A:122
Profiling ultrafiltration without a preset model.....................................................A:122
Profiling sodium without a preset model.............................................................A:123
Profiling bicarbonate without a preset model......................................................A:124
Set and activate profiling with a preset model ................................................... A:125
Measuring blood pressure .............................................................................................. A:127
Blood pressure monitor (BPM) ............................................................................ A:128
Blood pressure cuff............................................................................................... A:128
Direct blood pressure measuring ........................................................................ A:130
Interval blood pressure measuring...................................................................... A:130
Measurement history ............................................................................................ A:131
Set alarm limits ...................................................................................................... A:131
Patient care during blood pressure measuring.................................................. A:132
All patients .......................................................................................................... A:132
Patients with high blood pressure....................................................................... A:133
Patients with arrhythmia ..................................................................................... A:134
DIASCAN ........................................................................................................................... A:135
How DIASCAN function works ............................................................................. A:136
What DIASCAN function checks .......................................................................... A:136
Check K and Kt ...................................................................................................... A:136
Check Kt/V.............................................................................................................. A:137
Measurement history ............................................................................................ A:138
Set a Kt/V target value........................................................................................... A:139
6.1
6.2
6.2.1
6.2.2
6.2.3
6.3
6.3.1
7
7.1
7.2
7.3
7.4
7.5
7.5.1
7.5.2
7.5.3
7.6
8
8.1
8.2
8.3
8.4
8.5
8.6
8.7
8.7.1
8.7.2
8.7.3
9
9.1
9.2
9.3
9.4
9.5
9.6
HCEN12745 Revision 10.2016
Program version 2.xx
Set an alarm for low K or Kt/V .............................................................................. A:140
Factors that affect measuring .............................................................................. A:140
10
Disinfection and cleaning ................................................................................................ A:143
Disinfection and cleaning – general .................................................................... A:144
Check before you start.......................................................................................... A:144
Heat disinfection.................................................................................................... A:145
Description of heat disinfection........................................................................... A:145
Cleaning and decalcification...............................................................................A:145
Start a heat disinfection ...................................................................................... A:146
Start a heat disinfection with a CLEANCART cartridge......................................A:146
Start a heat disinfection with liquid citric acid ..................................................... A:146
Start a short heat disinfection with liquid citric acid ............................................ A:147
Integrated heat disinfection ................................................................................A:147
Integrated heat disinfection ............................................................................A:147
To schedule a heat disinfection program ........................................................ A:147
To turn off a scheduled program.....................................................................A:148
Integrated heat disinfection with a WRO 300 H unit...........................................A:149
Integrated heat disinfection with a WRO 300 H unit.......................................A:149
Chemical disinfection ........................................................................................... A:149
About chemical disinfection ................................................................................ A:149
Start a chemical disinfection...............................................................................A:149
Start a central chemical disinfection ................................................................... A:150
Chemical disinfection program with a WRO unit ................................................ A:151
Test for disinfectant residues .............................................................................. A:151
Disinfection history .............................................................................................A:152
About chemical disinfectants .............................................................................. A:152
Rinse and Drain ..................................................................................................... A:153
Start rinse or drain .............................................................................................. A:153
To schedule a rinse program .............................................................................. A:153
To turn off rinse program for a certain day.......................................................... A:154
Machine storage with chemical disinfectant ...................................................... A:154
Fill the dialysis machine with chemical disinfectant............................................A:154
Start using a dialysis machine filled with chemical disinfectant..........................A:155
Reference ............................................................................................................... A:156
Disinfection, Decalcification and Cleaning Agents - Characteristics ..................A:156
Cleaning and disinfection schedule .................................................................... A:156
Flow path ............................................................................................................ A:157
Disinfection with the AK 98 dialysis machine and WRO system.................................A:159
General description............................................................................................... A:160
Integrated heat disinfection with a WRO 300 H unit .......................................... A:160
Description of integrated heat disinfection with a WRO 300 H unit .................... A:160
Schedule an integrated heat disinfection............................................................ A:160
Start an integrated heat disinfection manually....................................................A:160
9.7
9.8
10.1
10.2
10.3
10.3.1
10.3.2
10.3.3
10.3.4
10.3.5
10.3.6
10.3.7
10.3.7.1
10.3.7.2
10.3.7.3
10.3.8
10.3.8.1
10.4
10.4.1
10.4.2
10.4.3
10.4.4
10.4.5
10.4.6
10.4.7
10.5
10.5.1
10.5.2
10.5.3
10.6
10.6.1
10.6.2
10.7
10.7.1
10.7.2
10.7.3
11
11.1
11.2
11.2.1
11.2.2
11.2.3
HCEN12745 Revision 10.2016
Program version 2.xx
11.3
Central chemical disinfection program with a WRO unit .................................. A:161
Description of central chemical disinfection program with a WRO unit ..............A:161
Start a central chemical disinfection with a WRO unit ........................................ A:161
Settings for rinse ................................................................................................... A:163
Rinse settings ..................................................................................................... A:163
IT Connectivity.................................................................................................................. A:165
Basic functionality................................................................................................. A:166
is confirmed ....................................................................................................... A:166
Cancel prescription retrieval ................................................................................ A:168
Clearing Patient ID and patient prescription....................................................... A:168
Setting treatment parameters manually .............................................................. A:169
Setting Station ID................................................................................................... A:169
Unconfirmed patient with data transfer only ...................................................... A:170
Maintenance handling...................................................................................................... A:171
Maintenance........................................................................................................... A:172
Blood Pump Rotor................................................................................................. A:172
Maintenence of the blood pump rotor.................................................................A:172
Clean the blood pump rotor ................................................................................ A:172
Clean the blood leak detector .............................................................................. A:173
Water inlet tube...................................................................................................... A:173
Pick-up tubes ......................................................................................................... A:173
Surface ................................................................................................................... A:174
Change ultrafilter................................................................................................... A:174
Storage ................................................................................................................... A:175
Service.................................................................................................................... A:175
Disposal.................................................................................................................. A:176
Technical data and specifications .................................................................................. A:177
Performance and specification - Control System .............................................. A:178
Blood flow control ............................................................................................... A:178
Heparin pump ..................................................................................................... A:178
Blood pressure ...................................................................................................A:178
Blood pressure monitor (BPM) ........................................................................... A:178
Dialysis fluid preparation ....................................................................................A:179
Ultrafiltration control............................................................................................ A:180
Ultrafiltration protective.......................................................................................A:180
Profiling............................................................................................................... A:180
DIASCAN function .............................................................................................. A:180
Disinfection and cleaning – chemical disinfection ..............................................A:180
11.3.1
11.3.2
11.4
11.4.1
12
12.1
12.2 Confirmed Patient ID and retrieval of patient prescription when the Patient ID
12.3
12.4
12.5
12.6
12.7
13
13.1
14
13.2
13.2.1
13.2.2
13.3
13.4
13.5
13.6
13.7
13.8
13.9
13.10
14.1
14.1.1
14.1.2
14.1.3
14.1.4
14.1.5
14.1.6
14.1.7
14.1.8
14.1.9
14.1.10
HCEN12745 Revision 10.2016
Program version 2.xx
14.1.11
Disinfection and cleaning - heat disinfection ......................................................A:181
Auto heat disinfection ......................................................................................... A:182
Heat disinfection program including WRO 300 H ............................................... A:182
Disinfection and cleaning – rinse/drain...............................................................A:182
Disinfection and cleaning – exterior cleaning ..................................................... A:183
Water supply....................................................................................................... A:183
Power supply ...................................................................................................... A:183
Network connection ............................................................................................ A:184
Connection of external equipment......................................................................A:184
Battery back-up ..................................................................................................A:185
Performance and specification - Supervisory system....................................... A:185
Blood pressure supervision ................................................................................ A:185
Air detection........................................................................................................ A:185
Extracorporeal blood loss due to coagulation.....................................................A:186
Dialysis fluid preparation ....................................................................................A:186
TMP .................................................................................................................... A:186
Blood leakage detection ..................................................................................... A:186
Alarm sound pressure .......................................................................................... A:186
Alarm sound pressure ........................................................................................A:186
Physical data.......................................................................................................... A:186
Dimensions and weight ......................................................................................A:186
Infusion stand ..................................................................................................... A:187
Materials in contact with dialysis fluid, concentrates, and water .................... A:187
Polymers............................................................................................................. A:187
Metals ................................................................................................................. A:187
Other materials ................................................................................................... A:187
Environmental data ............................................................................................... A:188
Operation............................................................................................................ A:188
Transportation and storage ................................................................................A:188
Electromagnetic environment ............................................................................. A:188
Expected service life........................................................................................... A:191
Energy and water consumption .......................................................................... A:192
Standards ............................................................................................................... A:192
Local regulatory registration (if applicable) .................................................................. A:195
14.1.12
14.1.13
14.1.14
14.1.15
14.1.16
14.1.17
14.1.18
14.1.19
14.1.20
14.2
14.2.1
14.2.2
14.2.3
14.2.4
14.2.5
14.2.6
14.3
14.3.1
14.4
14.4.1
14.4.2
15
14.5
14.5.1
14.5.2
14.5.3
14.6
14.6.1
14.6.2
14.6.3
14.6.4
14.6.5
14.7
HCEN12745 Revision 10.2016
Program version 2.xx
1 Before you get started
Important while reading the operator’s manual ................................................... A:10
About this operator´s manual ...............................................................................A:10
Safety definitions .................................................................................................. A:10
Values and settings .............................................................................................. A:10
Buttons .................................................................................................................A:10
About the screen .................................................................................................. A:11
Symbols................................................................................................................ A:12
General warning and precautions before use ...................................................... A:15
General precautions before use ........................................................................... A:15
Responsibility and disclaimer ............................................................................... A:17
Leakage current and potential equalisation connection .......................................A:18
Treatment location................................................................................................ A:18
Central venous catheter .......................................................................................A:18
Connection of external electrical equipment......................................................... A:18
How to move the AK 98 dialysis machine ............................................................A:18
Safety philosophy ................................................................................................. A:19
Intended use ............................................................................................................ A:19
Intended use......................................................................................................... A:19
Training................................................................................................................. A:20
Disinfection and functional check ......................................................................... A:20
Inlet water requirements ....................................................................................... A:21
Hygienic quality of central delivery systems ......................................................... A:21
Preparing dialysis fluid.......................................................................................... A:21
Accessories ............................................................................................................. A:21
Concentrates, chemical disinfectants, accessories and disposables ...................A:21
Concentrates ........................................................................................................ A:22
Chemical disinfectants.......................................................................................... A:22
Blood lines ............................................................................................................ A:23
Accessories .......................................................................................................... A:23
Ultrafilter ............................................................................................................... A:24
Dialyzers............................................................................................................... A:24
Blood pressure measurement accessories ..........................................................A:24
Glossary ................................................................................................................... A:25
Glossary ...............................................................................................................A:25
1.1
1.1.1
1.1.2
1.1.3
1.1.4
1.1.5
1.1.6
1.2
1.2.1
1.2.2
1.2.3
1.2.4
1.2.5
1.2.6
1.2.7
1.2.8
1.3
1.3.1
1.3.2
1.3.3
1.3.4
1.3.5
1.3.6
1.4
1.4.1
1.4.2
1.4.3
1.4.4
1.4.5
1.4.6
1.4.7
1.4.8
1.5
1.5.1
HCEN12745 Revision 10.2016
Program version 2.xx
AK 98 Dialysis Machine - Before you get started A:9
1.1 Important while reading the operator’s manual
limits. See Section 1.1.5 “About the screen” on pageA:11. All values and settings in
operator´s panel” on pageA:11. The illustrations in the handling instructions do not
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
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
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.
A:10 AK 98 Dialysis Machine - Before you get started
HCEN12745 Revision 10.2016
Program version 2.xx
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.
HCEN12745 Revision 10.2016
Program version 2.xx
AK 98 Dialysis Machine - Before you get started A:11
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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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.
The following symbols are found on the BICART cartridge holder:
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Cuff index line must fall within range markings.
AK 98 Dialysis Machine - Before you get started A:13
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
Table 1-1. 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
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!
pageA:19. Verify that the first digit of the program version of both the machine
“Electromagnetic environment” on pageA:188.
pageA:177.
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
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
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
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.
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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.
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CAUTION!
When moving the dialysis machine, take a firm hold on the transportation handle
and gently move the device over obstacles. Do not move the machine with anything
hanging from the infusion stand or with anything standing at the base plate of the
machine as this may make the dialysis machine unstable.
1.2.8 Safety philosophy
To maintain a safe treatment the AK 98 dialysis machine contains a control system and
a protective system. Controllable treatment parameters (i.e. conductivity, temperature
and ultrafiltration) are supervised by the control system.
The protective system triggers an alarm if a treatment value is outside its alarm limits.
When an alarm is triggered, the protective system takes appropriate measures and
puts the AK 98 dialysis machine into a patient-safe condition, for example by stopping
the blood pump, closing the venous clamp or preventing the dialysis fluid from
reaching the dialyzer.
The functionality of the protective system is checked by the AK 98 dialysis machine
during functional check before each treatment. A fault detection during the
pre-treatment tests will make it impossible to start the treatment.
Ultrafiltration
The ultrafiltration supervision feature uses an independent pair of flow sensors for the
ultrafiltration protective system.
Venous pressure
The protective system checks the venous pressure to prevent patient blood loss.
WARNING!
Under certain circumstances the patient may suffer from blood loss, without the
venous pressure passing any alarm limit. To avoid this, make sure that the blood
circuit and the needle are correctly connected, tight and secure and that the low
alarm limit is set as close as possible to the actual venous pressure.
Blood pump
The protective system checks how long time the blood pump is stopped during a
treatment, to make sure the blood in the dialysis machine blood lines does not
coagulate.
Blood leak detector
The protective system checks that the blood leak detector is able to detect the
presence of blood in the dialysis fluid.
Air detector
Any air that enters the blood lines upstream of the air detector is trapped in the venous
drip chamber. After a certain volume of air has been trapped an alarm is given.
1.3 Intended use
1.3.1 Intended use
The AK 98 dialysis machine is intended for use as a single patient machine to perform
haemodialysis treatments of patients with renal failure or fluid overload upon
prescription by a physician. Patient counselling and teaching of treatment techniques
are directly under the supervision and discretion of the physician. The AK 98 dialysis
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machine is intended for the in- center environment and care in a home healthcare
pageA:76
environment.
WARNING!
Treatment in a home healthcare environment shall only be allowed if the operator
has received proper training to enable her / him to prepare the machine, perform
and end the treatment in a safe way, and disinfect and clean the machine between
treatments. Training shall be based on a profile assuming maximum of eight years of
operator’s education. The physician is responsible to ensure that the competence of
the operator is checked on regular basis. Records of the training and competence
checks shall be archived by the responsible physician.
CAUTION!
Patient education, counselling, home care follow-up and medical maintenance must
be performed under the direction and supervision of the physician prescribing the
treatment. Baxter specifically denies any responsibility for patient education,
counselling or home care and medical maintenance.
CAUTION!
When the AK 98 dialysis machine is used to produce bicarbonate containing dialysis
fluid originating from non-liquid concentrates, the AK 98 dialysis machine is
designed and validated for use with the BICART cartridge. Baxter does not accept
responsibility for use of other non-liquid concentrate containers as the proper
functionality cannot be guaranteed.
CAUTION!
The physician is responsible to ensure that the operator has access to the AK 98
operator’s manual when performing haemodialysis in a home healthcare
environment.
CAUTION!
Additional measures to supervise the patient weight loss is recommended when
treating low weight patients or when performing long treatments. For Ultrafiltration
details, refer to Technical data and specifications.
NOTE!
The AK 98 dialysis machine is intended for continuous operation.
1.3.2 Training
Everyone that works with the dialysis machine, its accessories or the patient, must go
through proper training to learn about haemodialysis and how to handle the dialysis
machine in a correct and safe way.
This operator's manual is the primary training material for anyone who is to operate the
AK 98 dialysis system.
It is essential to read or being trained on the full content of the Operator’s manual
before operating the AK 98 dialysis machine.
Training can be arranged after request from your local Baxter representative.
1.3.3 Disinfection and functional check
Always perform a disinfection after installation, before initial use.
When the dialysis machine is new it needs to complete an extended functional check
before you can connect the patient. See Section 4.2.2 “Start functional check” on
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1.3.4 Inlet water requirements
14.1.16 “Water supply” on pageA:183.
accessories and disposables” on pageA:21.
The inlet water must meet a number of requirements regarding its quality. Normally this
requires some technical equipment to purify the water.
Maintaining and disinfecting this equipment, including the distribution loop, regularly is
essential.
The inlet water must comply with valid standards for water for dialysis; see Section
Failure to meet the requirements of the inlet water may lead to hemolysis due to
undesired substances in the water.
1.3.5 Hygienic quality of central delivery systems
The user is responsible for the hygienic quality of any delivery systems, e.g. central
water supply system, central delivery systems, haemodialysis equipment connecting
devices, including the fluid lines from connection points to the haemodialysis
equipment.
1.3.6 Preparing dialysis fluid
The dialysis machine can prepare dialysis fluid from incoming water, acidic (A)
concentrate and dry bicarbonate concentrate (BICART cartridge).
Dialysis fluid can also consist of incoming water, an acidic (A) concentrate and a liquid
bicarbonate (B) concentrate. See Section 1.4.1 “Concentrates, chemical disinfectants,
1.4 Accessories
1.4.1 Concentrates, chemical disinfectants, accessories and disposables
Baxter does not accept responsibility if the dialysis machine is used with concentrates,
chemical disinfectants, accessories, or disposables other than those specified in this
section. Using other material may reduce Baxter’s warranties for the dialysis machine.
WARNING!
To ensure proper functionality of the AK 98 dialysis machine, use only concentrates,
chemical disinfectants, accessories, and disposables specified as follows as these
has been tested and validated for use with the AK 98 dialysis machine.
CAUTION!
Baxter does not accept any responsibility or liability for use of concentrates,
chemical disinfectants, accessories, or disposables other than those specified as
follows. Depending on the circumstances, use of concentrates, chemical
disinfectants, accessories, or disposables other than those specified may also
reduce Baxter’s warranties for the AK 98 dialysis machine.
CAUTION!
To ensure proper functionality of the dialysis machine, observe the manufacturer's
instructions for use regarding blood lines and dialyzers for single use.
NOTE!
The user should make sure a current listing of concentrates, chemical disinfectants,
accessories, and disposables is available.
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NOTE!
14.1.10 “Disinfection and cleaning – chemical disinfection” on pageA:180. Chemical
chemical disinfectants” on pageA:152.
The user should follow the facility procedures for proper disposal of used blood
lines, dialyzers and other disposables per local regulations.
1.4.2 Concentrates
Accessories mentioned in this section are approved and required for use with the
AK 98 dialysis machine.
CAUTION!
Incorrect choice of dialysis fluid concentrate may cause incorrect composition of the
dialysis fluid. Incorrect composition may lead to electrolytic imbalance in the patient's
blood.
Table 1-2. Liquid concentrates
Liquid concentrates Intended use
SOFTPAC
G- and C-series
SOFTPAC Citrate
G- and C-series
The SOFTPAC product is an acid concentrate
for bicarbonate based hemodialysis and is
intended to be used together with the BICART
cartridge for on-line preparation of
hemodialysis, hemodiafiltration or
hemofiltration fluids on compatible Baxter
dialysis machines.
To obtain a current listing of recommended
concentrates contact your local sales office.
The SOFTPAC Citrate product is intended to
be used as a citrate based acid concentrate
together with the BICART cartridge for on-line
preparation of hemodialysis, hemodiafiltration
and hemofiltration fluids on compatible Baxter
dialysis machines.
Table 1-3. Non-liquid concentrates
Non-liquid concentrates Intended use
BICART cartridge Dry bicarbonate concentrate for preparation of
1.4.3 Chemical disinfectants
Accessories mentioned in this section are approved and required for use with the
AK 98 dialysis machine.
Chemicals suitable for disinfection and concentrations thereof are listed in Section
disinfectants may be harmful to the materials used in the fluid path of dialysis
machines. Therefore it is important to use the right disinfectant and be aware of the
precautions for a certain chemical disinfectant before use, see Section 10.4.7 “About
To obtain a current listing of recommended
concentrates contact your local sales office.
bicarbonate dialysis fluid together with proper
liquid A-concentrate.
To obtain a current listing of recommended
concentrates contact your local sales office.
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1.4.4 Blood lines
Accessories mentioned in this section are approved and required for use with the
AK 98 dialysis machine.
CAUTION!
Do not use the neonatal blood lines: A-5.128-B4, V-5.127-X, A-5.129-B4 or
V-5.129-X with AK 98 dialysis machine as these neonatal blood lines are not
intended for use with the AK 98 dialysis machine.
Table 1-4. Blood lines
Line number Area of use
The following blood lines manufactured by Gambro,
are available for use on AK 98 dialysis machine:
GMB S Series Arterial and venous blood line set
GMB Series Arterial and venous blood line set
CBL Series Arterial and venous blood line set
BL 10 series Arterial and venous blood line set
BL 95 SN Arterial and venous blood line set
BL 120N Arterial and venous blood line set
BL 100 Series Arterial and venous blood line set
BL 200 Series Arterial and venous blood line set
BL 200 S Series Arterial and venous blood line set
A 5000 and V 5000 Series Arterial and venous blood lines
The following blood lines manufactured by Vital,
are available for use on AK 98 dialysis machine:
BL 05 Arterial and venous blood line set
BL 24 Arterial and venous blood line set
BL 25 Arterial and venous blood line set
BL 90 Arterial and venous blood line set
BL 008 Arterial blood line set
BL 009 Venous blood line set
BL 10 R Arterial and venous blood line set
BL 10 Arterial and venous blood line set
BL 90 D4 Arterial and venous blood line set
BL 14 Arterial and venous blood line set
1.4.5 Accessories
Table 1-5. Accessories
Line number Area of use
C series Haemodialysis accessories
C 705 A connection line with an expansion chamber.
SP series Haemodialysis accessories
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1.4.6 Ultrafilter
Accessories mentioned in this section are approved and required for use with the
AK 98 dialysis machine.
The dialysis machine has a holder for an ultrafilter. The purpose of the ultrafilter is to
clean the dialysis fluid further from possible contamination by bacteria and endotoxins.
Table 1-6. Ultrafilter
Ultrafilter Area of use
U9000 Ultrafilter used for preparation of ultra filtered
1.4.7 Dialyzers
Accessories mentioned in this section are approved and required for use with the
AK 98 dialysis machine.
NOTE!
The listed dialyzers have been determined by Baxter to meet the specifications and
instructions for use given for the AK 98 dialysis machine with regards to e.g. the
recommended priming procedure; in addition, the connectors and the ports of the
dialyzers comply with ISO 8637 and EN 1283.
Table 1-7. Dialyzers
Dialyzer Area of use
POLYFLUX
series
REVACLEAR
series
EVODIAL
series
THERANOVA
series
dialysis fluid.
These hollow fiber dialyzers have been
validated by Baxter for use with the AK 98
dialysis machine.
1.4.8 Blood pressure measurement accessories
Accessories mentioned in this section are approved and required for use with the
AK 98 dialysis machine.
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Table 1-8. Blood pressure measurement accessories
and cleaning – general” on pageA:144.
pageA:144.
pageA:144.
functional check” on pageA:76.
GAMBRO Cuff Size
Adult 23 - 33 cm
Large Adult 31 - 40 cm
Small Adult 17- 25 cm
Child 12 - 19 cm
GAMBRO Cuff
(single hand)
Adult 28 - 37 cm
Large Adult 36 - 46 cm
Small Adult 21 - 29 cm
GAMBRO Cuff hose
3.0 m Cuff hose is used to connect cuff and AK 98
1.5 Glossary
1.5.1 Glossary
Table 1-9. Defintions
Authorised service technician A service technician certified by Baxter.
Size
dialysis machine.
CIS Clinical Information System
Cleaning Removing fats, proteins and organic material
from the fluid path downstream of the dialyzer
(post dialyzer). See Section 10.1 “Disinfection
Decalcification Removing calcium and magnesium-carbonate
from the fluid path, originating from the
bicarbonate dialysis fluid. See Section 10.1
“Disinfection and cleaning – general” on
Disinfection A process that destroys or removes
microorganisms. See Section 10.1
“Disinfection and cleaning – general” on
Dwell Time The period that the fluid path is filled with
disinfectant.
Functional check Before a treatment can be started the dialysis
machine performs a functional check. The
machine checks that internal functions are
working. The machine performs either an
extended functional check or a shorter basic
functional check. See Section 4.2.2 “Start
"Functional check" in this manual refers to
either basic functional check or extended
functional check. When a specific functional
check is described "extended functional check"
or "basic functional check" will be used.
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Operator A person who has knowledge of, and has been
trained in haemodialysis. The operator is in
charge of the machine, which means that the
operator makes the machine settings, which
have to be done before, during, and after the
haemodialysis treatment. It is important that
the operator has access to the AK 98
Operator’s manual when performing
haemodialysis treatment. The operator is
sometimes referred to as ”you”.
When performing haemodialysis treatment in a
home healthcare environment, the operator
can also be the patient.
Patient environment The patient environment is the volume
surrounding the patient during treatment. The
size of this patient environment must be
determined from case to case by the user and
the authorised service technician.
Patient ID A patient unique alphanumeric code, used to
identify the patient in the Clinical Information
System.
Physician A person prescribing the treatment of the
patient.
User A person who has the comprehensive
responsibility for how the AK 98 dialysis
machine is being used. The user decides
which local routines are applicable for the
AK 98 dialysis machine.
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2 Machine Description
Blood part................................................................................................................. A:28
Blood part components......................................................................................... A:28
Blood part component details ............................................................................... A:29
Fluid part .................................................................................................................. A:36
Fluid part components .......................................................................................... A:36
Fluid part component details ................................................................................A:37
Rear component ...................................................................................................... A:44
Rear components ................................................................................................. A:44
Rear component details........................................................................................ A:45
2.1
2.1.1
2.1.2
2.2
2.2.1
2.2.2
2.3
2.3.1
2.3.2
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2.1 Blood part
2.1.1 Blood part components
Figure 2-1. Blood part component terms
A:28 AK 98 Dialysis Machine - Machine Description
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