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AK 200 S / AK 200 ULTRA S

Dialysis Machine

Service Manual

Order number:
MHCEN9281-03/16
Copyright
Copyright 2001-2003, 2005, 2007, 2009, 2010, 2012, 2016 Gambro Lundia AB.

Trademarks
Gambro, AK 200 S, AK 200 ULTRA S, BiCart, BiCart Select, CleanCart, Diascan, Exalis,
SelectBag, and SelectCart are trademarks belonging to the Gambro Group.
PEEK is a trademark of Victrex plc.
Dialox is a trademark of L'Air Liquide.

Manufacturer
Gambro Lundia AB
Box 10101
Magistratsvgen 16
SE-220 10 LUND
Sweden
Phone +46 46 169000
www.gambro.com
Sales representative contact information, (if applicable):

Questions or comments about this publication can be directed to your local representative or to the
manufacturer.

HCEN9281 Revision 03.2016


Table of contents

1 General information ................................................................................................................ 1

1.1 About this manual ......................................................................................................... 2

1.2 Installation...................................................................................................................... 2

1.3 Complaint ....................................................................................................................... 3

1.4 Disclaimer ...................................................................................................................... 3

1.5 Maintenance................................................................................................................... 3

1.6 Competence of Service Engineers .............................................................................. 3

1.7 Repair ............................................................................................................................. 4

1.8 Technical support .......................................................................................................... 4

1.9 Waste disposal............................................................................................................... 4

1.10 List of symbols .............................................................................................................. 4

2 Installation Guide .................................................................................................................... 6

2.1 Before installation ......................................................................................................... 7


2.1.1 Qualification requirements......................................................................................... 7
2.1.2 Tools .......................................................................................................................... 7
2.1.3 Manufacturer ............................................................................................................. 7

2.2 Unpacking and inspection............................................................................................ 7

2.3 Mains Voltage and Power Consumption ..................................................................... 8


2.3.1 Plugging in the machine ............................................................................................ 8
2.3.2 Power supply ............................................................................................................. 8
2.3.3 Service Outlets .......................................................................................................... 9
2.3.4 Line Fuses ................................................................................................................. 9

2.4 Mains Water Supply....................................................................................................... 9

2.5 Drain ............................................................................................................................. 10

2.6 Batteries ....................................................................................................................... 10


2.6.1 9 V Battery............................................................................................................... 10
2.6.2 Back-up Battery ....................................................................................................... 10

2.7 Assembling the Monitor Stand................................................................................... 11


2.7.1 General.................................................................................................................... 11
2.7.2 MS 200 - Adjustable height: five fixed positions ...................................................... 12
2.7.3 MS 200 - Adjusted for installation of WRO 300 / WRO 300 H................................. 15
2.7.4 MS 202 - Adjustable height: continuous variable .................................................... 20

2.8 Positioning the dialysis machine on the stand ........................................................ 25

2.9 Installation instructions for AK 200 S dialysis machine ...................................... 27

2.10 Installation instructions for AK 200 ULTRA S dialysis machine ......................... 31

HCEN9281 Revision 03.2016


2.11 Initial start-up procedure ............................................................................................ 35
2.11.1 First check ............................................................................................................... 35
2.11.2 Start-up procedure................................................................................................... 36

2.12 Service reporting - installation................................................................................... 37

2.13 Checklist - installation ................................................................................................ 38

3 Maintenance manual ............................................................................................................. 40

3.1 General ......................................................................................................................... 41

3.2 Test equipment ............................................................................................................ 41

3.3 Preventive maintenance ............................................................................................. 42


3.3.1 Base-kit.................................................................................................................... 42
3.3.1.1 Parts in the Base-kit ............................................................................................ 42
3.3.1.2 How to exchange the parts included in the Base-kit............................................ 43
3.3.1.3 Actions to carry out after the parts have been exchanged .................................. 48
3.3.2 Supplementary A-kit ............................................................................................... 66
3.3.2.1 Parts in the Supplementary A-kit ......................................................................... 66
3.3.2.2 How to exchange the exterior parts included in the A-kit ................................... 67
3.3.2.3 Actions to carry out after the parts have been exchanged .................................. 68
3.3.3 Supplementary B-kit ................................................................................................ 70
3.3.3.1 Parts in the Supplementary B-kit ......................................................................... 70
3.3.3.2 How to exchange the overhaul parts included in the B-kit .................................. 70
3.3.3.3 Actions to carry out after the parts have been exchanged ................................. 72

3.4 Defibrillator use ........................................................................................................... 72


3.4.1 Test after defibrillator use ........................................................................................ 72
3.4.2 Actions, test after defibrillator use ........................................................................... 73

4 Replacements ........................................................................................................................ 74

4.1 General ........................................................................................................................ 75

4.2 Replacement of components .................................................................................... 75


4.2.1 Change actions........................................................................................................ 75

4.3 Replacement of Batteries .......................................................................................... 77


4.3.1 List of batteries in AK 200 S and AK 200 ULTRA S dialysis machines
............................................................................................................................ 77
4.3.2 Battery and electronic waste handling .................................................................... 77

4.4 Replacement of power supply cord........................................................................... 77

5 Maintenance support description ........................................................................................ 78

5.1 Operator's panel .......................................................................................................... 80


5.1.1 Buttons and displays ............................................................................................... 80
5.1.2 Treatment overview ................................................................................................. 81
5.1.2.1 Blood and fluid paths ........................................................................................... 81
5.1.2.2 Parameter buttons ............................................................................................... 82
5.1.2.3 Bargraph displays................................................................................................ 82

HCEN9281 Revision 03.2016


5.1.3 Stand-by group ........................................................................................................ 82
5.1.3.1 Stand-by group buttons ....................................................................................... 82
5.1.3.2 Alarm buttons ..................................................................................................... 83
5.1.4 Display and setting group ........................................................................................ 83
5.1.4.1 Overview.............................................................................................................. 83
5.1.4.2 Viewing trends on the screen ............................................................................. 83
5.1.4.3 Colours in parameter displays ............................................................................ 84
5.1.5 Light intensity adjustment ....................................................................................... 85
5.1.6 Light intensity on old panels .................................................................................... 85
5.1.6.1 Bargraph contrast ................................................................................................ 85
5.1.6.2 Backlight .............................................................................................................. 86
5.1.7 Treatment overview screen .................................................................................... 86
5.1.8 Functional check overview screen .......................................................................... 88

5.2 Maintenance support overview .................................................................................. 89


5.2.1 Available test procedures ........................................................................................ 89
5.2.2 Access the Maintenance Support Selection ........................................................... 89
5.2.3 To Exit ..................................................................................................................... 89
5.2.4 Logging mode.......................................................................................................... 89
5.2.4.1 Logging mode overview....................................................................................... 89
5.2.4.2 Logging mode flow diagram ................................................................................ 90
5.2.5 Arrays ...................................................................................................................... 91
5.2.6 AK 200 S dialysis machine Flow path with S-variables ....................................... 92
5.2.7 AK 200 S UFD dialysis machine Flow path with S-variables ............................... 93
5.2.8 AK 200 ULTRA S dialysis machine Flow path with S-variables ........................... 94
5.2.9 Logging diagram, S-variables for BM ..................................................................... 95

5.3 How to enter/exit Service/Preset mode ..................................................................... 96

5.4 Preset mode ................................................................................................................. 96


5.4.1 Custom setting......................................................................................................... 96
5.4.2 Configuration .......................................................................................................... 97
5.4.3 PC Preset ................................................................................................................ 98
5.4.4 Others...................................................................................................................... 98
5.4.4.1 Language version ................................................................................................ 98
5.4.4.2 Time settings ....................................................................................................... 99
5.4.4.3 Total default ........................................................................................................ 99
5.4.5 Start up mode ........................................................................................................ 100
5.4.6 Preset of concentrates .......................................................................................... 102

5.5 Service mode ............................................................................................................. 105


5.5.1 How to enter service mode.................................................................................... 105
5.5.2 Service mode flow diagram .................................................................................. 106
5.5.3 Blood monitor flow diagram, calibration ................................................................ 107
5.5.4 Fluid monitor flow diagram, calibration ................................................................. 108
5.5.5 Diagnostic flow diagram ....................................................................................... 109
5.5.6 Error Buffers flow diagram .................................................................................... 110
5.5.7 Diagnostics BM ...................................................................................................... 111
5.5.8 Diagnostics FM ..................................................................................................... 112
5.5.9 Utility flow diagram ............................................................................................... 113
5.5.10 Exalis flow diagram ............................................................................................. 114

HCEN9281 Revision 03.2016


5.5.11 Download new program version ............................................................................ 115
5.5.11.1 Tools needed ..................................................................................................... 115
5.5.11.2 Download software ............................................................................................ 115

6 Technical description........................................................................................................... 118

6.1 Introduction................................................................................................................ 120


6.1.1 General.................................................................................................................. 120
6.1.2 Main functions ....................................................................................................... 121
6.1.2.1 Overview............................................................................................................ 121
6.1.2.2 Quick preparation procedures ........................................................................... 121
6.1.2.3 Treatment flexibility............................................................................................ 121
6.1.2.4 Disinfection ........................................................................................................ 122
6.1.2.5 Options .............................................................................................................. 122
6.1.2.6 Others................................................................................................................ 122
6.1.3 Parameters ............................................................................................................ 122

6.2 Fluid Monitor, FM....................................................................................................... 123


6.2.1 Fluid Monitor.......................................................................................................... 123
6.2.2 FM flow diagram AK 200 ULTRA S dialysismachine ........................................ 124
6.2.3 Treatment .............................................................................................................. 125
6.2.3.1 Water intake....................................................................................................... 125
6.2.3.2 Concentrate ....................................................................................................... 125
6.2.3.3 Concentrate - FM............................................................................................... 126
6.2.3.4 BiCart Select System ...................................................................................... 126
6.2.3.5 Dialysis Fluid ..................................................................................................... 126
6.2.4 Design and Construction ....................................................................................... 129
6.2.5 FM valves .............................................................................................................. 134
6.2.6 Electrical circuit boards used in the fluid monitor .................................................. 136
6.2.6.1 Wiring ................................................................................................................ 136
6.2.6.2 FM CPU board................................................................................................... 136
6.2.6.3 FM Analog Distribution board ............................................................................ 139
6.2.6.4 FM Power Distribution board ............................................................................. 139
6.2.6.5 Blood leak Detector board ................................................................................. 139
6.2.6.6 Conductivity cell board ...................................................................................... 139
6.2.6.7 Blood pressure monitor board ........................................................................... 139

6.3 Blood Monitor, BM..................................................................................................... 140


6.3.1 Blood Monitor ........................................................................................................ 140
6.3.2 Treatment .............................................................................................................. 141
6.3.2.1 Double Needle Treatment - HD ......................................................................... 141
6.3.2.2 Single Needle Treatment ................................................................................... 142
6.3.2.2.1 Single Pump .................................................................................................. 142
6.3.2.2.2 Double pump ................................................................................................. 143
6.3.2.3 Double Needle Treatment ................................................................................. 144
6.3.2.3.1 Flow diagrams ............................................................................................... 144
6.3.2.3.2 HDF Low Volume........................................................................................... 144
6.3.2.3.3 HDF on line.................................................................................................... 144
6.3.2.3.4 HF on line ...................................................................................................... 145

HCEN9281 Revision 03.2016


6.3.3 Design and Construction ....................................................................................... 145
6.3.3.1 Level Detector (Air detector).............................................................................. 145
6.3.3.2 Batteries ............................................................................................................ 145
6.3.3.3 Blood Pump Unit................................................................................................ 145
6.3.3.4 BVS - Blood Volume Sensor.............................................................................. 145
6.3.3.5 Drip Chamber Level Adjustment........................................................................ 146
6.3.3.6 Fan .................................................................................................................... 146
6.3.3.7 Heparin Pump Unit ............................................................................................ 146
6.3.3.8 Line Clamp Unit ................................................................................................. 146
6.3.3.9 Operator's Panel................................................................................................ 146
6.3.3.10 Pressure Transducers ....................................................................................... 146
6.3.3.11 Priming Detector................................................................................................ 147
6.3.3.12 BPM - Blood Pressure Monitor .......................................................................... 147
6.3.4 Electrical circuit boards used in the blood monitor ................................................ 148
6.3.4.1 Wiring ................................................................................................................ 148
6.3.4.2 BM Analog Distribution Board ........................................................................... 148
6.3.4.3 Jumpers on the BM Analog Distribution board .................................................. 148
6.3.4.4 Panel Control Board .......................................................................................... 148
6.3.4.5 Jumpers on the Panel Control Board ................................................................ 148
6.3.4.6 BM CPU Board .................................................................................................. 149
6.3.4.7 Jumpers on the BM CPU board......................................................................... 149
6.3.4.8 Connectors on the BM CPU Board.................................................................... 150

6.4 Power Supply............................................................................................................. 151

6.5 Monitor stand............................................................................................................. 152

7 Technical data and specifications - AK 200 S dialysis machine ................................. 154

7.1 Performance and specification - Control System ................................................. 155


7.1.1 Notes ..................................................................................................................... 155
7.1.2 Blood Flow Control ................................................................................................ 155
7.1.3 Air Detection .......................................................................................................... 155
7.1.4 Heparin Administration .......................................................................................... 156
7.1.5 Blood Volume Sensor (BVS) ................................................................................. 156
7.1.6 Blood Pressure Monitor (BPM).............................................................................. 156
7.1.7 Dialysis fluid preparation ....................................................................................... 156
7.1.8 Dialysis fluid preparation (BiCart Select concentrate system mode
only)................................................................................................................... 157
7.1.9 Ultrafiltration control............................................................................................... 157
7.1.10 Profiling.................................................................................................................. 158
7.1.11 Diascan ................................................................................................................ 158
7.1.12 Disinfection and Cleaning...................................................................................... 159
7.1.13 Water supply.......................................................................................................... 162
7.1.14 Drain ...................................................................................................................... 162
7.1.15 Power supply ......................................................................................................... 162
7.1.16 Connection of external equipment......................................................................... 163
7.1.17 Battery Back-up ..................................................................................................... 164

7.2 Performance and specification - Supervisory system .......................................... 164


7.2.1 Valid accuracy range ............................................................................................. 164
7.2.2 Blood Pressure Supervision .................................................................................. 164

HCEN9281 Revision 03.2016


7.2.3 Air Detection .......................................................................................................... 165
7.2.4 Heparin Administration .......................................................................................... 165
7.2.5 Dialysis fluid preparation ....................................................................................... 165
7.2.6 Dialysis fluid preparation (BiCart Select concentrate system mode
only)................................................................................................................... 166
7.2.7 Ultrafiltration .......................................................................................................... 166
7.2.8 Blood leak detection .............................................................................................. 166
7.2.9 Blood loss due to coagulation................................................................................ 166

7.3 Physical data.............................................................................................................. 166

7.4 Materials in contact with water, concentrates and dialysis fluid ......................... 167
7.4.1 Polymers................................................................................................................ 167
7.4.2 Metals .................................................................................................................... 167
7.4.3 Others.................................................................................................................... 167

7.5 Environmental data ................................................................................................... 168


7.5.1 Operation............................................................................................................... 168
7.5.2 Transportation and storage ................................................................................... 168
7.5.3 Energy ................................................................................................................... 168
7.5.4 Electromagnetic environment ................................................................................ 168

7.6 Standards ................................................................................................................... 171

8 Technical data and specifications - AK 200 ULTRA S dialysis machine .................... 172

8.1 Performance and specification - Control System ................................................. 173


8.1.1 Notes ..................................................................................................................... 173
8.1.2 Blood Flow Control ................................................................................................ 173
8.1.3 Air Detection ......................................................................................................... 173
8.1.4 Heparin Administration .......................................................................................... 174
8.1.5 Blood Volume Sensor (BVS) ................................................................................. 174
8.1.6 Blood Pressure Monitor (BPM).............................................................................. 174
8.1.7 Dialysis fluid preparation ....................................................................................... 174
8.1.8 Dialysis fluid preparation (BiCart Select concentrate system mode
only)................................................................................................................... 175
8.1.9 Ultrafiltration control............................................................................................... 176
8.1.10 Substitution fluid .................................................................................................... 176
8.1.11 Profiling.................................................................................................................. 176
8.1.12 Diascan ................................................................................................................ 176
8.1.13 Disinfection and Cleaning...................................................................................... 177
8.1.14 Water supply.......................................................................................................... 179
8.1.15 Drain ...................................................................................................................... 179
8.1.16 Power supply ......................................................................................................... 179
8.1.17 Connection of external equipment......................................................................... 180
8.1.18 Battery Back-up ..................................................................................................... 181

8.2 Performance and specification - Supervisory system .......................................... 181


8.2.1 Valid accuracy range ............................................................................................. 181
8.2.2 Blood Pressure Supervision .................................................................................. 181
8.2.3 Air Detection .......................................................................................................... 182
8.2.4 Heparin Administration .......................................................................................... 182
8.2.5 Dialysis fluid preparation ....................................................................................... 182

HCEN9281 Revision 03.2016


8.2.6 Dialysis fluid preparation (BiCart Select concentrate system mode
only)................................................................................................................... 183
8.2.7 Ultrafiltration .......................................................................................................... 183
8.2.8 Blood leak detection .............................................................................................. 183
8.2.9 Blood loss due to coagulation................................................................................ 183

8.3 Physical data.............................................................................................................. 183

8.4 Materials in contact with water, concentrates and dialysis fluid ......................... 184
8.4.1 Polymers................................................................................................................ 184
8.4.2 Metals .................................................................................................................... 184
8.4.3 Others.................................................................................................................... 184

8.5 Environmental data ................................................................................................... 185


8.5.1 Operation............................................................................................................... 185
8.5.2 Transportation and storage ................................................................................... 185
8.5.3 Energy ................................................................................................................... 185
8.5.4 Electromagnetic environment ................................................................................ 185

8.6 Standards ................................................................................................................... 188

9 Electrical Safety Inspection................................................................................................ 189

9.1 General ....................................................................................................................... 190

9.2 Visual inspection ....................................................................................................... 190

9.3 PET - Protective Earth Test....................................................................................... 191


9.3.1 Test equipment for PET - Protective Earth Test..................................................... 191
9.3.2 PET (Protective Earth Test) for AK 95 S dialysis machines............................... 191
9.3.3 PET (Protective Earth Test) for AK 96 dialysis machine ..................................... 191
9.3.4 PET (Protective Earth Test) for AK 200 S / AK 200 ULTRA S dialysis
machines ........................................................................................................... 192

9.4 ELT / PLT..................................................................................................................... 192


9.4.1 Test equipment for ELT / PLT ................................................................................ 192
9.4.2 General conditions for ELT / PLT........................................................................... 192
9.4.3 ELT - Earth Leakage Current Test ......................................................................... 193
9.4.4 PLT - Patient Leakage Current Test ...................................................................... 194

9.5 Record of Electrical Safety Inspection .................................................................... 196

10 Wiring diagram .................................................................................................................... 199

11 Calibration manual .............................................................................................................. 201

11.1 General ....................................................................................................................... 203

11.2 Calibration, Fluid Monitor ......................................................................................... 203


11.2.1 Technical Facilities................................................................................................. 203
11.2.2 A/D Converter FM (CPU Q), FM 21....................................................................... 204
11.2.3 A/D Converter FM (CPU F;1), FM 22 .................................................................... 205
11.2.4 A/D Converter FM (CPU F;2), FM 23 .................................................................... 206
11.2.5 Temperature FM CPU Board calibration, FM 0 ..................................................... 207
11.2.6 Degassing Transducer calibration, FM 7 ............................................................... 208
11.2.7 Flow Output Pressure Transducer calibration, FM 8 ............................................. 209

HCEN9281 Revision 03.2016


11.2.8 Flow Input Pressure Transducer calibration, FM 9 ................................................ 211
11.2.9 High Pressure Guard Transducer calibration, FM 10 ............................................ 212
11.2.10 Dialysis Fluid Pressure Transducer (PD) calibration, FM 11 ................................. 214
11.2.11 Safety Guard Pressure Transducer calibration, FM 12 ......................................... 215
11.2.12 pH-sensor calibration, FM 13 ................................................................................ 217
11.2.12.1 Equipment needed ............................................................................................ 217
11.2.12.2 Calibration steps................................................................................................ 217
11.2.12.3 Offset calibration................................................................................................ 217
11.2.12.4 Complete calibration.......................................................................................... 218
11.2.13 Blood Leakage Detector calibration, FM 24 .......................................................... 219
11.2.14 Internal pressure regulator calibration (AK 200 ULTRA S dialysis machine
only)................................................................................................................... 220
11.2.15 Inlet pressure regulator adjustment ....................................................................... 221
11.2.16 Conductivity Transducer calibration, FM 20 - with liquid concentrate ................... 222
11.2.17 Conductivity Transducer calibration, FM 20 - with SelectCart cartridge ................ 223
11.2.18 BiCart Select - Level detector calibration............................................................. 225
11.2.18.1 Equipment needed ............................................................................................ 225
11.2.18.2 General.............................................................................................................. 225
11.2.18.3 Calibration instruction ........................................................................................ 226
11.2.18.4 Trouble shooting ................................................................................................ 227
11.2.19 BiCart Select - control and protective pump calibration ....................................... 227
11.2.19.1 Equipment needed ............................................................................................ 227
11.2.19.2 General.............................................................................................................. 227
11.2.19.3 Preparations ...................................................................................................... 228
11.2.19.4 Calibration instruction ........................................................................................ 229
11.2.19.5 Verification ......................................................................................................... 230
11.2.20 Calibration of Flow Restrictor Node (FRN) main flow supervision......................... 230
11.2.20.1 General.............................................................................................................. 230
11.2.20.2 Calibration instruction, with liquid concentrate .................................................. 231
11.2.20.3 Calibration instruction, with SelectCart cartridge............................................... 232
11.2.20.4 Trouble shooting ................................................................................................ 232
11.2.21 Automatic UF calibration/Supervision flowmeter calibration.................................. 233
11.2.21.1 Equipment needed ............................................................................................ 233
11.2.21.2 General.............................................................................................................. 233
11.2.21.3 Running the UF calibration, with liquid concentrate .......................................... 234
11.2.21.4 Running the UF calibration, with SelectCart cartridge....................................... 234
11.2.21.5 Verification of the UF cell calibration ................................................................. 235

11.3 Calibration, Blood Monitor ....................................................................................... 236


11.3.1 A/D Converter BM(CPU P), BM 4.......................................................................... 236
11.3.2 Venous Pressure Transducer calibration, BM 3 .................................................... 238
11.3.3 Arterial Pressure Transducer calibration, BM 2 ..................................................... 240
11.3.4 System Pressure Transducer calibration, BM 1 .................................................... 242
11.3.5 Level Detector calibration (Air detector), BM 5...................................................... 243
11.3.6 Trouble shooting .................................................................................................... 244
11.3.7 Priming Detector calibration, BM 6 ........................................................................ 245
11.3.8 Blood Volume Sensor - BVS.................................................................................. 245
11.3.9 Temperature BM CPU Board calibration, BM 0 ..................................................... 245
11.3.10 Occlusion adjustment, blood pump/substitution flow pump................................... 246

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11.3.11 BPM test ................................................................................................................ 247
11.3.11.1 Equipment needed ............................................................................................ 247
11.3.11.2 Test method ....................................................................................................... 247
11.3.11.3 BPM sub-test ..................................................................................................... 248
11.3.11.4 Check of air leakage.......................................................................................... 248
11.3.11.5 Check of inflation speed .................................................................................... 249
11.3.11.6 Check of pressure transducer calibration and measured pressure ................... 249

11.4 Logging after calibration .......................................................................................... 249


11.4.1 GXL-logging........................................................................................................... 249
11.4.2 Procedure .............................................................................................................. 250
11.4.3 Logging values ...................................................................................................... 250

12 FM flow diagrams ................................................................................................................ 252

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This page is intentionally left blank.
1 General information
1.1 About this manual ......................................................................................................... 2

1.2 Installation...................................................................................................................... 2

1.3 Complaint ....................................................................................................................... 3

1.4 Disclaimer ...................................................................................................................... 3

1.5 Maintenance................................................................................................................... 3

1.6 Competence of Service Engineers .............................................................................. 3

1.7 Repair ............................................................................................................................. 4

1.8 Technical support .......................................................................................................... 4

1.9 Waste disposal............................................................................................................... 4

1.10 List of symbols .............................................................................................................. 4

HCEN12395 Revision 03.2016


General information 1
1.1 About this manual
1 General information

This service manual provides the information needed to install the


AK 200 S / AK 200 ULTRA S dialysis machine, to carry out maintenance, component
replacements and calibrations. It is a guidance how to identify and repair faults that
may occur.
This service manual also provides a technical description of the functionality of the
AK 200 S / AK 200 ULTRA S dialysis machine, including technical data.
Questions or comments about this publication can be directed to your local
representative or to the manufacturer.

Valid revision of AK 200S / AK 200 ULTRA S - Service Manual


AK 200 S / AK 200 ULTRA S - Service Manual, HCEN9281, Rev. 03.2016, consists of
following separate chapters:
Denomination Publication no./Revision
Ch.1 - General information HCEN12395, Rev. 03.2016
Ch.2 - Installation Guide HCEN9282, Rev. 03.2016
Ch.3 - Maintenance manual HCEN12088, Rev. 03.2016
Ch.4 - Replacements HCEN9284, Rev. 03.2016
Ch.5 - Maintenance support description HCEN9285, Rev. 03.2016
Ch.6 - Technical description HCEN9286, Rev. 03.2016
Ch.7 - Technical data and specifications - HCEN9287, Rev. 03.2016
AK200S dialysis machine
Ch.8 - Technical data and specifications - AK HCEN9297, Rev. 03.2016
200 ULTRA S dialysis machine
Ch.9 - Electrical safety inspections HCEN12190, Rev. 03.2016
Ch.10 - Wiring diagram, BM K20595 CO 23309
Ch.10 - Wiring diagram, FM K20583 CO 23309
Ch.11 - Calibration manual HCEN12089, Rev. 03.2016
Ch.12 - FM flow diagrams, AK 200 S dialysis HCEN10398 Rev. 02.2010
machine
HCEN10395 Rev. 02.2010
Ch.12 - FM flow diagrams, AK 200 S UFD
HCEN10399 Rev. 02.2010
dialysis machine
Ch.12 - FM flow diagrams, AK 200 ULTRA S
dialysis machine

NOTE!
This Service Manual is intended to be used for both AK200S and AK200ULTRAS
dialysis machines.
AK200ULTRAS Service manual, HCEN9291, will therefore be replaced by this
manual.

1.2 Installation
Installation of the machine should be done in accordance with the recommended
procedures in the AK 200 S / AK 200 ULTRA S - Installation guide, HCEN9282.
When installing a new monitor please ensure proper reporting in Gambros global
electronical service reporting system whether there are any deviations or not. This is
important information and it will assist us to improve the product for you.

HCEN12395 Revision 03.2016


2 General information
The initial installation and start up procedure of AK 200 S / AK 200 ULTRA S dialysis
machine, may only be performed by Gambro Technical Service organization or a

1 General information
person authorized by Gambro, fulfilling the specified qualifications stated in the Section
1.6 Competence of Service Engineers on page3.

1.3 Complaint
If a complaint is raised it shall be communicated to the relevant Gambro Sales
Company. In order for the Sales Company to be able to determine the relevance of a
complaint, it is of vital importance that the deviation is communicated to them as
comprehensive as the issue requires.
Complaints are important information and it will assist Gambro to improve the product
for you. The Complaint system is not valid for products, components or printed circuit
boards that isn't in its original delivered condition.

1.4 Disclaimer
The manufacturer accepts responsibility for the safety, reliability, and performance of
this equipment only if installation, operational procedures, maintenance, calibrations,
and repairs are carried out by appropriately trained and suitable qualified people; if all
equipment modifications are authorized in writing by the manufacturer and carried out
by appropriately trained and suitable qualified people; if the electrical installation of the
relevant room complies with all applicable local electrical codes and, if applicable, IEC
requirements; and if the equipment is used in accordance with the published
AK 200 S / AK 200 ULTRA S - Operators Manual.

1.5 Maintenance
To ensure proper operation of the AK 200 S / AK 200 ULTRA S dialysis machine, a
qualified service technician must perform a complete series of maintenance
procedures at regular intervals.
The maintenance and calibration information that you need to use is provided in this
Service Manual, refer to chapters Maintenance Manual and Calibrations.
It is mandatory to perform at least a preventive maintenance every second year. A
yearly maintenance is recommended. The rate of preventive maintenance might be
different due to variations of the operating environment.

1.6 Competence of Service Engineers


There is a certain minimum level of competence required for Service Engineers who
are to maintain and repair Gambro products, summarized as follows.
A Service Engineer is considered suitable qualified if he/she has:
1. Attended AK 200 S / AK 200 ULTRA S technical service course and has been
given a certificate stating that the technician has passed the course.
2. Access to the recommended test equipment and special tools detailed in this
Service Manual.
3. Access to the recommended spare parts, refer to AK 200 S / AK 200 ULTRA S -
Spare parts List, HCEN9288.
4. Access to and understanding of the AK 200 S / AK 200 ULTRA S - Operator's
Manual.

HCEN12395 Revision 03.2016


General information 3
In general, this policy implies that training will be carried out by Gambro Lundia AB,
while local markets are responsible for their own service organization.
1 General information

1.7 Repair
Parts which are sent for repair shall be sent to the following address:
Baxter / Gambro Lundia AB
Repair Shop
Scheelevgen 34
223 63 LUND
SWEDEN

1.8 Technical support


For technical support please contact your local Gambro Service representative.

1.9 Waste disposal


For the purpose of protecting the environment the AK 200 S / AK 200 ULTRA S
dialysis machine must not be disposed with general domestic waste, but shall be
separately collected for dismantling and recovery. Where applicable national
regulations shall be applied. Consult your relevant Gambro Sales Company for
information.

1.10 List of symbols


NOTE!
All symbols in this list may not be represented on this product.
Alternating current.

Protective earth (ground).

Warning, consult accompanying documents.

This symbol indicates that consultation of the accompanying documents prior to


equipment operation is critical to the safe operation of the device. The colours are blue
and white.
Note: This symbol is a complement to the warning triangle symbol.
Off (power, disconnection from the mains).

On (power, connection to the mains).

Type B, applied part (the extracorporeal circuit and the dialysis fluid circuit).

Handle with care.

This way up.

HCEN12395 Revision 03.2016


4 General information
Keep dry.

1 General information
Input /Output.

Manufacturer. The year of manufacturing may be included in the symbol expressed as


four digits.
The Manufacturer symbol can also look like this.

Heater power supply outlet.

Prohibited behaviour.

Equipotentiality.

Separate collection for electrical and electronic equipment.

Recyclable/renewable symbol - Corrugated Cardboard. According to GB 184552001.

This symbol indicates that the AK 200 S / AK 200 ULTRA S dialysis machine contains
toxic or hazardous substances or elements according to SJ/T 113632006.
The figure 25 indicates the corresponding environmental protection use period of the
AK 200 S / AK 200 ULTRA S dialysis machine.
The AK 200 S / AK 200 ULTRA S dialysis machine is protected against dripping water.

Catalogue number.

Serial number.

Humidity limitation. Upper and lower limit is expressed with numeric values in %.

Atmospheric pressure limitation. Upper and lower limit is expressed with numeric values
in kPa.
Temperature limitation. Upper and lower limit is expressed with numeric values in degree
Celsius or Fahrenheit.
The maximum stacking load permitted on the transport package.

Do not stack.

Electrostatic sensitive device.

HCEN12395 Revision 03.2016


General information 5
2 Installation Guide
2.1 Before installation ......................................................................................................... 7
2.1.1 Qualification requirements......................................................................................... 7
2.1.2 Tools .......................................................................................................................... 7
2.1.3 Manufacturer ............................................................................................................. 7

2.2 Unpacking and inspection............................................................................................ 7

2.3 Mains Voltage and Power Consumption ..................................................................... 8


2.3.1 Plugging in the machine ............................................................................................ 8
2.3.2 Power supply ............................................................................................................. 8
2.3.3 Service Outlets .......................................................................................................... 9
2.3.4 Line Fuses ................................................................................................................. 9

2.4 Mains Water Supply....................................................................................................... 9

2.5 Drain ............................................................................................................................. 10

2.6 Batteries ....................................................................................................................... 10


2.6.1 9 V Battery............................................................................................................... 10
2.6.2 Back-up Battery ....................................................................................................... 10

2.7 Assembling the Monitor Stand................................................................................... 11


2.7.1 General.................................................................................................................... 11
2.7.2 MS 200 - Adjustable height: five fixed positions ...................................................... 12
2.7.3 MS 200 - Adjusted for installation of WRO 300 / WRO 300 H................................. 15
2.7.4 MS 202 - Adjustable height: continuous variable .................................................... 20

2.8 Positioning the dialysis machine on the stand ........................................................ 25

2.9 Installation instructions for AK 200 S dialysis machine ...................................... 27

2.10 Installation instructions for AK 200 ULTRA S dialysis machine ......................... 31

2.11 Initial start-up procedure ............................................................................................ 35


2.11.1 First check ............................................................................................................... 35
2.11.2 Start-up procedure................................................................................................... 36

2.12 Service reporting - installation................................................................................... 37

2.13 Checklist - installation ................................................................................................ 38

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6 Installation Guide
2.1 Before installation

2.1.1 Qualification requirements


The initial installation and start-up procedure of the AK 200 S / AK 200 ULTRA S
dialysis machine, may only be performed by Gambro Technical Service organization or
a person authorized by Gambro, fulfilling the specified qualifications in
AK 200 S / AK 200 ULTRA S - Service manual, Chapter 1 - Section 1.6 Competence
of Service Engineers on page3.

2 Installation Guide
2.1.2 Tools
Recommended tools needed for installation of AK 200 S / AK 200 ULTRA S dialysis
machine:
Phillips screwdrivers:
PH 2, length 100 mm
PH 2, length 250 mm
Flat screwdriver:
1 x 5.5 length 175 mm
Hexagon socket wrench (e.g. flex headed spanners HEX, Metric)
7 mm
13 mm
17 mm
Set of hexagon head keys
Cutting pliers
Tube cutter, e.g. 113500084

2.1.3 Manufacturer
Gambro Lundia AB
Box 10101
Magistratsvgen 16
SE-220 10 LUND
Sweden
Phone +46 46 169000
www.gambro.com

2.2 Unpacking and inspection


Check that the packaging material is not damaged. If the outer packaging is
damaged, lodge a complaint with the transporter before unpacking the equipment.
All packaging material should be disposed in accordance to local regulations.
Ensure that the specified equipment has been delivered. Do the packages contain
the specified monitor and options? Are there any units/components missing? If in
doubt, please contact your Gambro Service representative.

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Installation Guide 7
Ensure that the voltage specified on the voltage tag matches the mains voltage. If
in doubt, please contact your Gambro Service representative.
Check the equipment for any damages. If the equipment is in any way damaged,
proper operation cannot be guaranteed. Please contact your Gambro Service
representative.
2 Installation Guide

2.3 Mains Voltage and Power Consumption

2.3.1 Plugging in the machine


The AK 200 S / AK 200 ULTRA S dialysis machine must be plugged into a grounded
power socket, not more than 3.0 metres distant.

NOTE!
The 115 V-version require two grounded power sockets within 3.0 metres.

2.3.2 Power supply


Mains Voltage 115 or 230 V AC (10 %)
Frequency 50 or 60 Hz (5 Hz)
Power Consumption Max. 2250 W at 230 V
Max. 1650 W at 115 V
Mains cable: 3 conductor cable, Length max. 3 m rating 250
V 10 A, 13 -16A
Mains cable connector: Certified to IEC 60320/C19
Mains cable plug: Plug with protective earth, 250 V AC / 13 -16
A, or Hospital grade plug with protective earth,
125 V AC / 15 A
Earth Leakage Current max 500 A

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8 Installation Guide
Patient Leakage Current max 100 A
Fuses 2 x T 10 A

All leakage currents are specified without external equipment connected to the
machine.

2.3.3 Service Outlets


One extra grounded power socket should be available close to the dialysis machine for
troubleshooting (PC-logging) and maintenance purposes.

2 Installation Guide
2.3.4 Line Fuses
Never overload the line fuses and do not supply too many systems via a single line
fuse.

2.4 Mains Water Supply


Inlet Water Quality Inlet water quality must comply with local
regulations and if no such regulation is
available follow ISO 13959. Level for
conductivity shall not exceed 0.1 mS/cm. It is
possible to use water with higher conductivity if
it consists mainly of sodium salts. This may
however affect the accuracy of the fluid
composition.
Refer to AK 200 S and AK 200 ULTRA S
Operators manuals for more details regarding
inlet water requirements.
The machine is also prepared for using central
water supply for distribution of chemical
disinfectant (central chemical disinfection).
Inlet Water Pressure
to regulator 120 to 800 kPa
to machine 85 to 120 kPa

NOTE!
If a high frequent noise appears from the pressure regulator, do a small adjustment
of it up or down. (85 - 120 kPa)
Inlet Water Temperature
Treatment +5 to +30 C
Disinfection +5 to +90 C

Water Supply Flow Rate for AK 200 S dialysis


machine:
Treatment 300 to 750 ml/min
Disinfection 0 to 1150 ml/min
Water Supply Flow Rate for AK 200 ULTRA S
dialysis machine:
Treatment 450 to 850 ml/min
Disinfection 0 to 900 ml/min

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Installation Guide 9
2.5 Drain
Drain (length of tube) Maximum 5 m
Drain capacity Minimum 1.0 l/min
Drain outlet Maximum 1.2 m above floor

NOTE!
Local ordinances may require the use of special measures to protect against the
possibility of back-siphonage from dialysis equipment into the water supply. An air
gap to atmospheric pressure must always be arranged at the tube outlet. The drain
tube should not exceed 5 metres in length.
2 Installation Guide

2.6 Batteries

2.6.1 9 V Battery
The rechargeable 9 V battery, mounted inside the blood monitor, is used for the buzzer
alarm during main's power failure. The battery is not connected at delivery.

NOTE!
This battery must be connected during the installation. Refer to Section 2.9
Installation instructions for AK 200 S dialysis machine on page27 for AK 200 S
dialysis machine and Section 2.10 Installation instructions for AK 200 ULTRA S
dialysis machine on page31 for AK 200 ULTRA S dialysis machine.
A discharged battery will be charged with maximum 12 mA and it must be charged for
at least 50 hours to get completely charged. An fully charged battery will receive a
maintaining current of approximately 1.5 mA. AK 200 S / AK 200 ULTRA S dialysis
machine charges the battery as long as the power supply is switched on, i.e.
AK 200 S / AK 200 ULTRA S dialysis machine itself does not need to be switched on.
The battery is tested during every functional check to ensure that the capacity is
enough in the battery, otherwise an attention will be given:

A reminder to change or recharge the battery, must be confirmed in order to disappear.


If the attention is confirmed without change or recharge of the battery, note that there
is no battery back-up in case of a power failure during treatment. This means that the
machine will not be able to alarm or restart in case of a power failure.

WARNING!
Jumper J11 on the BM CPU board must be mounted for the rechargeable battery. If
use of an alkaline non-rechargeable battery, jumper J11 must be removed, if not, the
battery will be damaged.

2.6.2 Back-up Battery


Both lead acid batteries must be changed at the same time and only batteries
approved or supplied by Gambro Lundia AB may be used.
Changed batteries must be recycled or disposed of properly.

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10 Installation Guide
NOTE!
This battery must be connected during installation. Follow the assembling
instructions for the monitor stand in this chapter.
The installation and replacement of the back-up battery on the monitor stand must be
done according to this electrical diagram.

2 Installation Guide
Fuse: T15 A
Running time: 15 minutes

The charge indicator on the power supply is lit when the AK 200 S / AK 200 ULTRA S
dialysis machine is equipped with the back-up battery. The machine must be
connected to mains voltage and the mains switch must be on.
In a mains failure situation the following attention will be given.

Before the battery is empty the following attention will be given.

2.7 Assembling the Monitor Stand

2.7.1 General
The monitor stand MS 200 or MS 202 is partly preassembled at delivery. The items to
be mounted during installation are:
Lower frame, cover, pillar and upper frame
Battery back-up kit and transformer
Earth connections
Lift control kit
Remote control cable
Infusion stand holders
Filter holders

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Installation Guide 11
Here follows 3 separate instructions for assembling:
MS 200 - Adjustable height: five fixed positions
MS 200 - Adjusted for installation of WRO 300 / WRO 300 H
MS 202 - Adjustable height: continuous variable

2.7.2 MS 200 - Adjustable height: five fixed positions


Procedure

1) Step 1
2 Installation Guide

1. Place the lower frame of the stand


upside-down.
2. Attach the grounding sign beside the
earth screw.
3. Assemble the earth cable to the earth
screw.
4. Thread the earth cable and the battery
cable through the cable entry of the
lower frame.

NOTE!
This can also be done after
the lower frame has been
fastened, Step 4, Item 1.

2) Step 2
1. Adjust the height of the MS 200. Select
the desired position by using the
height adjustment screws.
MS 200 can be adjusted in five
different positions: total height
including the AK monitor is 1152 to
1382 mm.
2. Turn the pillar upside-down.
3. Put a thin string silicone on the lower
edge of the pillar. Remove all
unwanted silicone with a cloth.

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12 Installation Guide
3) Step 3
1. Place the lower frame (cover included)
on the pillar.

NOTE!
Be careful to match the parts
exactly to get the correct
passing at once (due to the
silicone).
Be careful not to damage the

2 Installation Guide
earth cable and the battery
cable when placing the parts
together.

4) Step 4
1. Fasten the lower frame (cover
included) to the pillar with four
hex-head screws (100382030), with a
hexagon socket wrench.
2. Assemble the holder for the infusion
pole with two screws (100388812).
3. Assemble the connector with two
screws (100370410).

NOTE!
Before mounting the
connector, remove two pins.

5) Step 5
1. Assemble the battery back-up kit
(K18652001) to the lower frame of the
stand with two screws (100388410).
2. Connect the battery cable to the
battery back-up.
3. Strap the battery cable to the bar.

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Installation Guide 13
6) Step 6
1. Attach the grounding sign beside the
earth screw.
2. Assemble the earth cable to the earth
screw.
3. Separate the rubber casing on the
battery cable (5 cm) and put it in the
opening of the upper edge.
4. Insert the sealing grommet in the
2 Installation Guide

opening of the short side upper edge.


(It is used for the power supply cord to
the electrically adjustable stand, MS
202).

7) Step 7
1. Fasten the upper frame to the pillar
with four screws (100389903).
2. Fasten the bracket for the dialysis fluid
filter holder and Water filter holder. Use
four screws (100388510).

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14 Installation Guide
8) Step 8
The filter holder to the right is used for
dialysis fluid filters.
The left filter holder is used for Water filters
(AK200ULTRAS dialysis machine only).
1. Fasten the filter holder to the right with
three screws (100378530).
2. AK200ULTRAS dialysis machine
only: Fasten the left filter holder with

2 Installation Guide
three screws (100378530).

2.7.3 MS 200 - Adjusted for installation of WRO 300 / WRO 300 H


Procedure

1) Step 1
1. Place the lower frame of the stand
upside-down.
2. Attach the grounding sign beside the
earth screw.
3. Assemble the earth cable to the earth
screw.
4. Thread the earth cable and the battery
cable through the cable entry of the
lower frame.
5. Loosen the four screws and remove
the battery holder, according to the
illustration.

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Installation Guide 15
2) Step 2
1. Adjust the height of the MS 200. When
using AK200S dialysis machine
together with WRO 300 / WRO 300 H
it is recommended to use the second
highest position to avoid the tubes
being squeezed. Select the desired
position by using the height adjustment
screws.
2. Turn the pillar upside-down.
2 Installation Guide

3. Put a thin string silicone on the lower


edge of the pillar. Remove all
unwanted silicone with a cloth.

3) Step 3
1. Place the lower frame (cover included)
on the pillar.

NOTE!
Be careful to match the parts
exactly to get the correct
passing at once (due to the
silicone).
Be careful not to damage the
earth cable and the battery
cable when placing the parts
together.

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16 Installation Guide
4) Step 4
1. Fasten the lower frame (cover
included) to the pillar with four
hex-head screws (100382030), with a
hexagon socket wrench.
2. Assemble the holder for the infusion
pole with two screws (100388812).
3. Assemble the connector with two
screws (100370410).

2 Installation Guide
NOTE!
Before mounting the
connector, remove two pins.

5) Step 5
1. Move the back-up batteries (1a)1 from
the holder included in the battery back-
up kit (K18652001) to the battery holder
adjusted for WRO 300 / WRO 300 H
(1b) according to the illustration.
NOTE!
Do not disconnect the cables
from the batteries, fuse
holder or the contact.
2. Mount the contact for the battery cable
and the fuse holder to the battery
holder.
3. Fasten the printed circuit board to the
battery holder with the adhesive quick
lock.
NOTE!
The electrical installation of
the back-up batteries must
remain according to the
diagram on the battery
holder.

1 including cables, fuse holder, contact for the battery cable and printed circuit board

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Installation Guide 17
6) Step 6
1. Assemble the complete battery holder
(including batteries, cables, fuse
holder, contact for the battery cable
and printed circuit board) to the lower
frame of the stand with four screws
(100388510).
2. Connect the battery cable to the
battery back-up.
3. Strap the battery cable to the bar.
2 Installation Guide

7) Step 7
1. Attach the grounding sign beside the
earth screw.
2. Assemble the earth cable to the earth
screw.
3. Separate the rubber casing on the
battery cable (5 cm) and put it in the
opening of the upper edge.
4. Insert the sealing grommet in the
opening of the short side upper edge.
(It is used for the power supply cord to
the electrically adjustable stand, MS
202)

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18 Installation Guide
8) Step 8
1. Fasten the upper frame to the pillar
with four screws (100389903).
2. Fasten the bracket for the dialysis fluid
filter holder and Water filter holder. Use
four screws (100388510) and four
washers 100392905.

2 Installation Guide
9) Step 9
The filter holder to the right is used for
dialysis fluid filters.
The left filter holder is used for Water filters
(AK200ULTRAS dialysis machine only).
1. Fasten the filter holder to the right with
three screws (100378530).
2. AK200ULTRAS dialysis machine
only: Fasten the left filter holder with
three screws (100378530).

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Installation Guide 19
10) Step 10
1. Place the WRO 300 / WRO 300 H
monitor on the bottom of the stand
according to the illustration.
2. Mount the tilt protection bar (K23902A)
in the two holes according to the
illustration.

NOTE!
Use the adaption kit
2 Installation Guide

(K2395501) to connect the


WRO 300 / WRO 300 H
monitor to
the
AK 200 S / AK 200 ULTRA S
dialysis machine.
Assembling instruction is
included in the kit.

2.7.4 MS 202 - Adjustable height: continuous variable


Procedure

1) Step 1
1. Place the lower frame of the stand
upside-down.
2. Insert and rotate the lift control kit by
lifting the lower frame.
3. Attach the grounding sign beside the
earth screw.
4. Assemble the earth cable to the earth
screw.
5. Thread the earth cable and the battery
cable through the cable entry of the
lower frame.

NOTE!
This can also be done after
the lower frame has been
fastened (Step 4, Item 1).

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20 Installation Guide
2) Step 2
1. Turn the pillar upside-down.
2. Place the contact in the carrier.
3. Put a thin string silicone on the lower
edge of the pillar. Remove all
unwanted silicone with a cloth.

NOTE!
MS 202 is variable adjustable
in height. Total height

2 Installation Guide
including the AK-monitor is
1175 to 1340 mm.

3) Step 3
1. Place the lower frame (cover included)
on the pillar.

NOTE!
Be careful to match the parts
exactly to get the correct
passing at once (due to the
silicone).
Be careful not to damage the
earth cable and the battery
cable when placing the parts
together.

4) Step 4
1. Fasten the lower frame (cover
included) to the pillar with four
hex-head screws (100382030), with a
hexagon socket wrench.
2. Connect the motor cable to the lift
control kit.
3. Connect the power cable from the lift
control kit to the battery back-up.
4. Connect the remote control cable to
the lift control kit.

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Installation Guide 21
5. Assemble screw (100388045) and
locking nut (100316260).
NOTE!
Adjust the stand until the
screw can be inserted.
6. Assemble the connector with two
screws (100370410).
NOTE!
Before mounting the
2 Installation Guide

connector, remove two pins.


7. Assemble the holder for the infusion
pole with two screws (100388812).
8. Raise the pillar 20 cm.
9. Remove the remote control cable from
the lift control kit.
10. Remove the power cable from the
battery back-up.
5) Step 5
1. Assemble the battery back-up kit
(K18652001) to the lower frame of the
stand with two screws (100388410).
2. Connect the battery cable to the
battery back-up and strap the cable to
the bar.
3. Strap the power cable and the two
battery cables to the bar.
4. Strap the motor cable and the power
cable.

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22 Installation Guide
6) Step 6
1. Lower the stand by removing the four
screws (100389903).
NOTE!
Hold the stand when
removing the last screw.
2. Attach the grounding sign beside the
earth screw.
3. Assemble the earth cable to the earth

2 Installation Guide
screw.
4. Separate the rubber casing on the
battery cable (5 cm) and put it in the
opening of the upper edge.
5. Lead the remote control cable through
the stand and through the bottom hole.
WARNING!
Beware of the
movement/rotation and the
sharp edges of the pillar.
6. Attach the remote control cable to the
lift control kit.
7. Cut the sealing grommet. Use ethanol
to simplify the assembly.
8. Insert the sealing grommet in the
opening of the short side upper edge
and stretch the cable according to the
maximum height of the stand.
9. Lower the pillar with the remote
control.

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Installation Guide 23
7) Step 7
1. Fasten the upper frame to the pillar
with four screws (100389903).
2. Raise the stand 20 cm with the remote
control.
3. Fasten the bracket for the dialysis fluid
filter holder and Water filter holder. Use
four screws (100388510).
2 Installation Guide

8) Step 8
The filter holder to the right is used for
dialysis fluid filters.
The left filter holder is used for Water filters
(AKULTRAS dialysis machine only).
1. Fasten the filter holder to the right with
three screws (100378530).
2. AK200ULTRAS dialysis machine
only: Fasten the left filter holder with
three screws (100378530).

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24 Installation Guide
2.8 Positioning the dialysis machine on the stand

2 Installation Guide

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Installation Guide 25
2 Installation Guide

Figure 2-1. Positioning: machine - stand


Procedure
1) Place the dialysis machine on the stand.

NOTE!
Observe that the plugged tubes from the fluid monitor at the bottom of the
machine fit into the holes in the stand.

2) Fix the fluid monitor with four screws, 100388512.

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26 Installation Guide
3) Connect the earth cable from the fluid monitor and mount the washers and nut.
See figure above.
4) Put the fluid protective tray on the top of the machine.

2.9 Installation instructions for AK 200 S dialysis machine


Procedure

1) Step 1 - Dialysis fluid filter holder (Only


for AK200S dialysis machines with

2 Installation Guide
UFD-kit)
1. Attach angled connectors to the tubes
coming from the fluid monitor.
Attach angled connectors to the
dialysis fluid filter holder.
Connect tube 132, 133 and 134 from
the dialysis fluid filter holder to the
tubes coming from the fluid monitor,
according to these figures.
2. Strap the tubes.
3. Insert a new ultrafilter into the dialysis
fluid filter holder according to
instructions in the AK200S Operator's
Manual.
2) Step 2 - pH-sensor
1. If a pH-sensor is to be installed,
remove the pH dummy and insert the
pH-sensor.

NOTE!
pH-sensor calibration
If the machine is equipped
with the pH-sensor option,
this must be calibrated during
installation. Ref. to
AK200S/AK200ULTRAS
Service Manual, chapter
Calibration manual.
It is important that the
pH-sensor is calibrated when
the dialysis machine is
installed, since the delivered
pH meter has not been
calibrated with the actual
machine.

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Installation Guide 27
3) Dialyzer connector set
a) Step 3a - Dialyzer connector set,
blue
1. Connect a sample port for 6 mm
tubes (K20219002) to the dialyzer
connector set (blue) with clamps ( 12
mm).
2. Attach the nut on the tube.
3. Attach an insert on the tube.
2 Installation Guide

4. Fasten it to the machine according


to the figure.
5. Fasten the blue safety coupling to
the right coupling on the machine.
b) Step 3b - Dialyzer connector set,
red
1. Attach the nut on the tube.
2. Attach an insert on the tube.
3. Fasten it to the machine according
to the figure.
4. Fasten the red safety coupling to
the left coupling on the machine.

4) Step 4 - Pressure regulator


1. Assemble the pressure regulator
(100313255) to the upper holder for
the infusion pole.
2. Fasten the upper holder for the
infusion pole with two screws
(100389903).

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28 Installation Guide
5) Step 5 - Infusion stand and service
handle
1. Fasten the infusion stand and the mast
top with one screw (100382816).
2. Fasten the service handle.

2 Installation Guide
6) Step 6 - BM - 9 V battery

WARNING!
Jumper J11 on the BM CPU
board must be mounted for
the rechargeable battery. If
use of an alkaline
non-rechargeable battery,
jumper J11 must be
removed, if not, the battery
will be damaged.

The rechargeable 9 V battery inside the


Blood monitor must be connected during
the installation.
1. Connect the battery cable to connector
P51 on the BM CPU board.
7) Step 7 - Connection of hoses
Connect following hoses according to the
figure:
1. Connect the inlet water hose (no. 1)
from the pressure regulator to the
water supply.
2. Connect hose no. 2 from the pressure
regulator to the non-return valve.
3. Connect hose no. 3 from the
non-return valve to the inlet water
nipple.
4. Connect hose no. 4 from the drain
nipple to the drain.

HCEN9282 Revision 03.2016


Installation Guide 29
Item Denominat Order no. Clamp
ion
1. Reinforced 100312213 100334217
PVC tube
2. Reinforced 100312094 100334217
silicon tube
8 x 3.5 mm
3. Reinforced 100312094 100334217
silicon tube
8 x 3.5 mm
2 Installation Guide

4. Reinforced 100312213 100334217


PVC tube

8) Step 8 - Power supply

WARNING!
The mains power cable from
the AK200S dialysis
machine must be plugged
into a socket with Protective
Earth (PE) to avoid risk of
electrical shock.

1. Connect the machine to a grounded


power socket, not more than 3.0
metres in distance.

NOTE!
The 115 V-version require
two grounded power sockets
within 3.0 metres.
The mains power should be
be supplied by a unique fuse
group from the main central.
Ensure that other equipment
connected to the same
central does not load the
voltage supply in a manner
that decreases the supplied
voltage to levels outside the
limits.

9) Step 9 - Connection of external


equipment
Following connections are located at the
rear of the machine:
Yellow (P79): Relay interface
Black (P63): PC-serial connection and
program load interface
Blue (P76): UF-cell calibration
interface, WRO 300 / WRO 300 H
Ethernet (P64): Ethernet
PC-connection and program load
interface. Intended for Exalis computer
system.

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30 Installation Guide
2.10 Installation instructions for AK 200 ULTRA S dialysis
machine
Procedure

1) Step 1 - Dialysis fluid filter holder


1. Attach angled connectors to the tubes
coming from the fluid monitor.
Attach angled connectors to the
dialysis fluid filter holder.

2 Installation Guide
Connect tube 132, 133 and 134 from
the dialysis fluid filter holder to the
tubes coming from the fluid monitor,
according to these figures.
2. Insert a new ultrafilter into the dialysis
fluid filter holder according to
instructions in the AK 200 ULTRA S
Operators Manual.
3. Insert a new ultrafilter into the dialysis
fluid filter holder according to
instructions in the AK 200 ULTRA S
Operators Manual.
2) Step 2 - pH-sensor
1. If a pH-sensor is to be installed,
remove the pH dummy and insert the
pH-sensor.

NOTE!
pH-sensor calibration
If the machine is equipped
with the pH-sensor option,
this must be calibrated during
installation. Ref. to
AK200S/AK200ULTRAS
ServiceManual, chapter
Calibration manual.
It is important that the
pH-sensor is calibrated when
the dialysis machine is
installed, since the delivered
pH meter has not been
calibrated with the actual
machine.

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Installation Guide 31
3) Dialyzer connector set
a) Step 3a - Dialyzer connector set,
blue
1. Connect a sample port for 6 mm
tubes (K20219002) to the dialyzer
connector set (blue) with clamps ( 12
mm).
2. Attach the nut on the tube.
3. Attach an insert on the tube.
2 Installation Guide

4. Fasten it to the machine according


to the figure.
5. Fasten the blue safety coupling to
the right coupling on the machine.
b) Step 3b - Dialyzer connector set,
red
1. Attach the nut on the tube.
2. Attach an insert on the tube.
3. Fasten it to the machine according
to the figure.
4. Fasten the red safety coupling to
the left coupling on the machine.

4) Step 4 - Pressure regulator


1. Assemble the pressure regulator
(100313255) to the upper holder for
the infusion pole.
2. Fasten the upper holder for the
infusion pole with two screws
(100389903).

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32 Installation Guide
5) Step 5 - Infusion stand and service
handle
1. Fasten the infusion stand and the mast
top with one screw (100382816).
2. Fasten the service handle.

2 Installation Guide
6) Step 6 - BM - 9 V battery

WARNING!
Jumper J11 on the BM CPU
board must be mounted for
the rechargeable battery. If
use of an alkaline
non-rechargeable battery,
jumper J11 must be
removed, if not, the battery
will be damaged.

The rechargeable 9 V battery inside the


Blood monitor must be connected during
the installation.
1. Connect the battery cable to connector
P51 on the BM CPU board.
7) Step 7 - Connection of hoses and Water
filter
Connect following hoses according to the
figure on the next page:
1. Connect the inlet water hose (no. 1)
from the pressure regulator to the
water supply.
2. Connect hose no. 2 from the pressure
regulator to the non-return valve.
3. Connect hose no. 3 from the
non-return valve to the inlet water
nipple.
4. Connect hose no. 4 to the Water filter
from the upper left nipple.
5. Connect hose no. 5 from the Water
filter to the upper right nipple.
6. Connect hose no. 6 from the drain port
of the Water filter to the drain.

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Installation Guide 33
7. Connect hose no. 7 from the drain
nipple to the drain.
8. Insert a new ultrafilter into the Water
filter holder according to instructions in
the AK 200 ULTRA S Operator's
Manual.
Item Denominat Order no. Clamp
ion
1. Reinforced 100312213 100334217
PVC tube
2 Installation Guide

2. Reinforced 100312094 100334217


silicon tube
8 x 3.5 mm
3. Reinforced 100312094 100334217
silicon tube
8 x 3.5 mm
4. Reinforced 100312094 100334217
silicon tube
8 x 3.5 mm
5. Reinforced 100312094 100334217
silicon tube
8 x 3.5 mm
6. Reinforced 100312213 100334217
PVC tube
7. Reinforced 100312213 100334217
PVC tube
8. Ultrafilter U 8000 S

8) Step 8 - Power supply

WARNING!
The mains power cable from
the AK200ULTRAS dialysis
machine must be plugged
into a socket with Protective
Earth (PE) to avoid risk of
electrical shock.

1. Connect the machine to a grounded


power socket, not more than 3.0
metres in distant.

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34 Installation Guide
NOTE!
The 115 V-version require
two grounded power sockets
within 3.0 metres.
The mains power should be
be supplied by a unique fuse
group from the main central.
Ensure that other equipment
connected to the same
central does not load the

2 Installation Guide
voltage supply in a manner
that decreases the supplied
voltage to levels outside the
limits.

9) Step 9 - Connection of external


equipment
Following connections are located at the
rear of the machine:
Yellow (P79): Relay interface
Black (P63): PC-serial connection and
program load interface
Blue (P76): UF-cell calibration
interface, WRO 300 / WRO 300 H
Ethernet (P64): Ethernet
PC-connection and program load
interface. Intended for Exalis computer
system.

2.11 Initial start-up procedure

2.11.1 First check


That the 9 V battery is installed.
That the mains cable is connected to a grounded power socket, not more than 3.0
metres from the machine.

NOTE!
Ensure that the voltage specified on the voltage tag matches the mains voltage. If in
doubt, please contact your Gambro Service representative.
The main switch on the power supply should always be in ON position, even when
the AK 200 S / AK 200 ULTRA S dialysis machine is not in use. This Stand by
mode is indicated by a lit segment on the TIME display on the Operator's panel.

That the machine is connected to the water supply.


That the drain tube is properly connected to the machine and placed with an air
gap between the drain tube and the drain.

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Installation Guide 35
That both the red and blue dialysis fluid tubes are connected to the safety bypass
unit.
AK 200 S dialysis machine: That the optional U 8000 S filter (Ultrafilter used as
dialysis fluid filter) is installed in the dialysis fluid filter holder.
AK 200 ULTRA S dialysis machine: That the U 8000 S filters (Ultrafilter used as
water filter and dialysis fluid filter) are installed in the dialysis fluid filter holder and
the Water filter holder.

2.11.2 Start-up procedure


2 Installation Guide

Procedure
1) Press the ON/OFF button for 3 seconds.
2) Preset the machine according to the clinics demand. Refer to
AK 200 S / AK 200 ULTRA S - Service Manual, chapter: Maintenance support
description / Preset mode.
3) pH-sensor calibration:
If the AK 200 S / AK 200 ULTRA S dialysis machine is equipped with the
pH-sensor option, this must be calibrated during installation. Refer to the
AK 200 S / AK 200 ULTRA S Service Manual, chapter Calibration manual, pH
sensor calibration.

NOTE!
It is important that the pH-sensor is calibrated when the
AK 200 S / AK 200 ULTRA S dialysis machine is installed, since the delivered
pH-meter has not been calibrated with the actual machine.

4) Adjust the inlet pressure regulator according to AK 200 S / AK 200 ULTRA S


Service Manual, chapter Calibration manual, Inlet pressure regulator adjustment.
5) To verify full functionality - let the AK 200 S / AK 200 ULTRA S dialysis machine
pass Fch.

NOTE!
Each time the AK 200 S / AK 200 ULTRA S dialysis machine is started, the
automatic functional check, Fch, is carried out. This check requires that the
dialysis fluid tubes are connected to the safety bypass unit. The dialysis fluid
tubes must remain connected to the safety bypass unit until Fch has
disappeared from the time display.

6) Perform a heat disinfection (or a chemical disinfection) according to the


AK 200 S / AK 200 ULTRA S - Operators Manual.
7) After the heat disinfection; re-tighten the nuts of the dialyser connector set to the
machine.
8) It is recommended to perform a simulated treatment according to instructions in
AK 200 S / AK 200 ULTRA S Maintenance Manual, HCEN12088, step 39.

WARNING!
After completing the installation process the composition of the dialysis fluid
should be confirmed in laboratory tests according to local regulations, before the
AK 200 S / AK 200 ULTRA S is ready for use. This is the responsibility of the
physician.

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36 Installation Guide
2.12 Service reporting - installation
When installing a new monitor please ensure proper reporting in Gambros global
electronical service reporting system whether there are any deviations or not.
This is important information and it will assist us to improve the product.

2 Installation Guide

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Installation Guide 37
2.13 Checklist - installation
Machine
AK 200 S dialysis machine
AK 200 ULTRA S dialysis machine

Serial number
FM: ____________________ BM: ____________________

Unpacking and inspection


2 Installation Guide

Ensure that the packaging material is not damaged.


Ensure that the specified equipment has been delivered.
Check that the additional package box contains the specified components.
Check, by visual inspection, that the machine shows no sign of damage.

Monitor Stand
Ensure that the Monitor Stand is assembled correctly according to the instructions
for MS 200, MS 200 - WRO 300 / WRO 300 H or MS 202.

MS 200
Step 1 Step 5
Step 2 Step 6
Step 3 Step 7
Step 4 Step 8

MS 200 - WRO 300 / WRO 300 H


Step 1 Step 5 Step 9
Step 2 Step 6 Step 10
Step 3 Step 7
Step 4 Step 8

MS 202
Step 1 Step 5
Step 2 Step 6
Step 3 Step 7
Step 4 Step 8

Positioning the dialysis machine on the stand


Place the AK 200 S / AK 200 ULTRA S dialysis machine on the stand
Fix the fluid monitor
Connect the earth cable
Ensure that the top tray is placed at the top of the machine

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38 Installation Guide
Installation of the AK200S / AK200ULTRAS dialysis machine
Step 1 Step 5 Step 9
Step 2 Step 6
Step 3 Step 7
Step 4 Step 8

Initial start-up procedure


Preset the machine according to the clinics demand.
If installed, calibrate pH sensor.

2 Installation Guide
Adjust inlet pressure regulator.
Functional check.
Heat disinfection.
Re-tighten the nuts of the of the dialyzer connector set to the machine.
Perform a simulated treatment (recommended)
Dialysis fluid sample submitted for analysis (recommended)

Service reporting - installation


Ensure proper reporting in Gambros global electronical service reporting system
whether there are any deviations or not.

NOTE!
If you have any remarks during installation, please contact your Gambro Service
representative.

This record is to be signed and filed by the Service Engineer responsible for the initial
installation and start-up procedure of this AK 200 S / AK 200 ULTRA S dialysis
machine.

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Installation Guide 39
3 Maintenance manual
3.1 General ......................................................................................................................... 41

3.2 Test equipment ............................................................................................................ 41

3.3 Preventive maintenance ............................................................................................. 42


3.3.1 Base-kit.................................................................................................................... 42
3.3.1.1 Parts in the Base-kit ............................................................................................ 42
3.3.1.2 How to exchange the parts included in the Base-kit............................................ 43
3.3.1.3 Actions to carry out after the parts have been exchanged .................................. 48
3.3.2 Supplementary A-kit ............................................................................................... 66
3.3.2.1 Parts in the Supplementary A-kit ......................................................................... 66
3.3.2.2 How to exchange the exterior parts included in the A-kit ................................... 67
3.3.2.3 Actions to carry out after the parts have been exchanged .................................. 68
3.3.3 Supplementary B-kit ................................................................................................ 70
3.3.3.1 Parts in the Supplementary B-kit ......................................................................... 70
3.3.3.2 How to exchange the overhaul parts included in the B-kit .................................. 70
3.3.3.3 Actions to carry out after the parts have been exchanged ................................. 72

3.4 Defibrillator use ........................................................................................................... 72


3.4.1 Test after defibrillator use ........................................................................................ 72
3.4.2 Actions, test after defibrillator use ........................................................................... 73

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40 Maintenance manual
3.1 General
To ensure proper operation of the AK 200 S / AK 200 ULTRA S dialysis machine, a
qualified service technician must perform a complete series of preventive maintenance
procedures at regular intervals. The maintenance and calibration information that you
need to use is provided in this manual.
The preventive maintenance procedures have been devised to require a minimum of
time while ensuring that the machine is maintained in optimum operation condition.
Included in the preventive maintenance procedures are checks to verify normal
machine operation. Should the machine fail to pass any of these tests, repair or
calibration might be needed, then repeat the tests until the specifications are met.
It is mandatory to perform at least one preventive maintenance every second year.
A yearly maintenance is recommended. The rate of preventive maintenance might be
different due to variations of the operating environment.
The AK 200 S / AK 200 ULTRA S dialysis machine will perform as designed only if it is
used and maintained in accordance with Gambros instructions. Any warranties made

3 Maintenance manual
by Gambro with respect to the AK 200 S / AK 200 ULTRA S dialysis machine are void
if the equipment is not used in accordance with the instructions provided. Gambro will
not accept responsibility for any damage or injury resulting from improper use or
maintenance or unauthorized repair.
To fulfil the preventive maintenance procedures for AK 200 S / AK 200 ULTRA S
dialysis machine some parts must be exchanged. The necessary parts to be
exchanged are available in one Base-kit and two complementary kits:
Base-kit (K40165001)
A-kit (K40166002): Includes exterior parts
B-kit (K40167001): Overhauling service-kit
When performing preventive maintenance procedures or calibrations, which require
access to the interior of the machine, you must have proper electrostatic safety
devices (i.e. wrist grounding straps or grounding mats) in place to prevent damage to
electrostatic sensitive components within the machine.

During repair of any of the parts in the flow path, special care should be taken and a
good hygiene should be kept.

NOTE!
After maintenance a disinfection program must be performed before a treatment is
performed.
Checklists are provided in the Spare Parts Instruction that is included in the
maintenance kits. The purpose of these checklists is to record the work done.

3.2 Test equipment


Test equipment needed to perform maintenance.

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Maintenance manual 41
Test equipment Tolerance Manufacturer Order number
Conductivity 0.1 mS/cm MESA, IBP
measurement
Pressure 2 mmHg within 200 MESA, IBP, Druck
measurement mmHg
1 % beyond 200
mmHg
If BPM is installed:
0.8 mmHg
Temperature 0.2 C MESA, IBP
measurement:
Digital Voltmeter 0.5 % Fluke
Measuring glass 5 ml Any
Blood leakage N/A Gambro K40169001
calibration cover
Gauge pin kit for blood T = 1.1 (Stop pin = 1.1 Gambro K40158001
3 Maintenance manual

pump rollers (including x 2 x 0.7 = 1.5 mm)


three different pins)
T = 1.6 (Stop pin = 1.6
x 2 x 0.7 = 2.2 mm)
T = 2.0 (Stop pin = 2.0
x 2 x 0.7 = 2.8 mm)
T = wall thickness of
the blood tubing
Calibration tube kit N/A Gambro K13983002
Drip chamber N/A Gambro N/A
Tube for calibration of N/A Gambro N/A
priming detector
Safety tester According to IEC Rigel, Biotec, Metron,
60601-1 Fluke
BPM test equipment (if N/A Gambro K22151001
installed)
BPM Cuff (if installed) N/A Gambro 110350
pH buffers (if installed) 0.07 pH units Any pH 7 100810001
pH 9 100810002
BVS test tool N/A Gambro K22281001
Magnet for blood N/A Gambro K19049002
pump cover
Leakage current Gambro K40246001
access point, PLT box

3.3 Preventive maintenance


3.3.1 Base-kit

3.3.1.1 Parts in the Base-kit


The Base-kit (K40165001) includes all parts necessary to fulfil the mandatory
preventive maintenance procedures for AK 200 S / AK 200 ULTRA S dialysis machine.

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42 Maintenance manual
Step Monitor Denomination Part no. Qty
2, 3 BM/FM Air filter K11503001 3
4 AC/DC Air filter K18891001 1
5, 6 FM O-ring for BiCart- 100319008 4
and SelectCart
cartridge holder,
upper and lower.
7 FM O-ring for 100319029 4
ultrafilter holders
7 FM Square-ring for K14920001 2
ultrafilter holders
8 FM Filter BiCart K16538C 2
cartridge holder,
upper and lower
(50m)
9 FM Filter SelectCart K16538C 1
cartridge holder,

3 Maintenance manual
lower (50m)
10 FM Filter after the K16538C 1
SelectBag
container holder
(50m)
11 FM Filter heating K14944001 1
vessel (250m)
12 FM V-ring heating 100318086 2
vessel
13 FM Membrane for K40153001 1
internal pressure
regulator
14 FM Membrane for K17989001 1
non-return valve
15 FM Sample port for 6 K20219002 1
mm tube
16 FM Sealing ring (Inlet K07994001 1
unit - heating
vessel)
16 FM Ring (Inlet unit - K08227001 1
heating vessel)
17 FM Sealing for K18184001 1
substitution fluid
port
18 FM Label K24092001 1

NOTE!
As a complement to the Base-kit, two additional kits are available; A- and B-kit.

3.3.1.2 How to exchange the parts included in the Base-kit


Procedure

1) First perform a combined heat disinfection


program with CleanCart C cartridge or
liquid citric acid. Then perform a heat
disinfection program in combination with
CleanCart A cartridge or a Chemical

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Maintenance manual 43
disinfection program with sodium
hypochlorite. Refer to the AK200S or
AK200ULTRAS Operators Manual.
2) Change air filters in the Blood Monitor.

3) Change air filter in the Fluid Monitor.


3 Maintenance manual

4) Change air filters in the AC/DC unit.

5) Change the upper and lower O-rings in the


BiCart cartridge holder.

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44 Maintenance manual
6) Change the upper and lower O-rings in the
SelectCart cartridge holder.

7) Change the O-rings and square-rings in


the ultrafilter holders. (Only for AK200S
with UFD-kit and AK200ULTRAS dialysis
machines)

NOTE!

3 Maintenance manual
This information is for step 8
to 10: To prevent that air is
getting trapped inside the
particle filters (50 m), it is
important that the particle
filters are correct positioned
according to this figure.

8) Change the upper and lower filters on the


BiCart cartridge holder (50 m).

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Maintenance manual 45
9) Change the lower filter on the SelectCart
cartridge holder (50 m).

10) Change the particle filter after the


SelectBag container holder (50 m)
3 Maintenance manual

11) Change the filter at the heating vessel (250


m).

12) Change the V-rings in the heating vessel.

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46 Maintenance manual
13) If ULTRA: Change the membrane for the
internal pressure regulator.

14) If ULTRA: Change the membrane for the


non-return valve.

3 Maintenance manual
15) Change the sample port.

16) Change the sealing ring and the ring on


the inlet unit inside the heating vessel.
It is important that the sealing ring is
reassembled with its flat side
according to this illustration.

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Maintenance manual 47
17) If ULTRA: Change the sealing for the
substitution fluid port on the FM front.

18) Mark month and year for the next


scheduled preventive maintenance. Attach
the label to the rear cover of the machine.
3 Maintenance manual

3.3.1.3 Actions to carry out after the parts have been exchanged
Procedure
1) Check that the screws for the blood pump(s) are tightened.

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48 Maintenance manual
2) Check that the screws for the hose clamps on the water inlet and drain tube are
tightened.

3 Maintenance manual
3) Check that the wheels are tightened.

4) Check that the screw for the infusion stand is tightened.

5) Perform the Protective Earth Test (PET) according to instructions available in


Electrical safety inspection for AK-machines.

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Maintenance manual 49
6) Check the insulation resistance in BM. Measure between TP 8 (Z0VL) on the BM
CPU board and the earth point on the bottom plate. Measure in M, should be > 1
M. The machine must be empty and switched off during measurement
The BM must be connected to the FM.

7) Check the insulation resistance in FM. Measure between TP 7 (Z0VL) on the


Power distribution board and the earth point on the back plate. Measure in M,
3 Maintenance manual

should be > 1 M. The machine must be empty and switched off during
measurement.

8) Erase the error code buffers. Enter service menu > Diagnose > System >
Errors > Erase

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50 Maintenance manual
9) BPM-test
Test method
Attach BPM cuff, 110350, tight to the BPM test equipment, K22151001.

3 Maintenance manual
Start the AK 200 S / AK 200 ULTRA S dialysis machine with the main switch
and the ON/OFF button.
Enter Service mode, Diagnose / BM / Others and BPM
BPM sub-tests
Following sub-tests are included:
Air leakage test: measures that the equipment is airtight.
Inflation speed test: measures the time to fill the cuff with air.
Static pressure: Check of pressure transducer calibration
Each of the tests can be carried out separately but the above order for
carrying out the sub-tests is recommended.
Check that the results from the sub-tests not exceed following limits:
Air leakage: maximum 18 mmHg / 3 min.
Inflation speed: 2 - 11 s
Static pressure: Maximum deviation from reference to be within 3 mmHg.
50 3 mmHg
150 3 mmHg
250 3 mmHg

Check of air leakage


By entering this test mode the air leakage for the BPM module, cuff hose and cuff
will be tested automatically. Before entering the test mode cuff and cuff hose to be
connected to the AK 200 S / AK 200 ULTRA S dialysis machine. Cuff to be
wrapped tight to the BPM test equipment.
BPM test equipment is used to simulate the patient arm circumference. The air
leakage is only tested for 90 sec but the value is recalculated for 3 minutes. If the
displayed value is above 18 mm Hg / 3 minutes, this indicates that there is a
possible air leakage in the system.
It is of course also possible to perform this test without the cuff and cuff hose
connected but then the test will only check for air leakage within the
AK 200 S / AK 200 ULTRA S dialysis machine. In this case replace the cuff and
cuff hose by a tube, which is closed.

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Maintenance manual 51
Check of inflation speed
By entering this test mode the capacity of the pump within the module will be
tested automatically. Before entering the test mode cuff and cuff hose to be
connected to the AK 200 S / AK 200 ULTRA S dialysis machine.
Cuff to be wrapped tight to the BPM test equipment. If the displayed time is above
11 seconds, this test indicates that the pump is worn-out.

Check of pressure transducer calibration and measured pressure


By entering this test mode it will be possible to check the actual pressure value of
the BPM pressure on the AK 200 S / AK 200 ULTRA S display.
Before entering the test mode, pressure transducer calibration tube from kit
K13983002 to be connected to the BPM connector on the
AK 200 S / AK 200 ULTRA S dialysis machine. No cuff and cuff hose to be
connected.

NOTE!
The pressure transducer calibration tube kit must be drained before being
3 Maintenance manual

connected, to make sure that no fluids or particles enters the BPM connector or
tubings. This might otherwise damage or destroy the sensitive BPM sensors.

When Measured pressure is displayed it is possible to start applying the external


reference pressure.

NOTE!
The BPM is equipped with an over pressure protection. It is activated for
pressures above 300 mmHg.
The pressure transducer test is to be performed within approx. 2 minutes. Then
the pressure is automatically released.

To check the actual pressure value, external pressure reference instrument to be


connected and external pressure of 250, 150, 50mmHg to be applied. Check
deviation from reference pressure instrument for displayed value.
10) Calibrate the Priming detector (BM 6).
Equipment needed: Reference tube
a) Start the AK 200 S / AK 200 ULTRA S dialysis machine and enter the service
menu, Calibr / BM.
b) Set the display to:

c) Press the Start UF Stop button to enter calibration routine.


d) The display shows:

e) Insert an empty reference tube in the priming detector. The reference tube
shall be from the same type of blood line as used during treatment.

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52 Maintenance manual
f) Press the lit Arrow button.
g) The calibration is now performed automatically and the calibration factor is
written into the EEPROM.
h) The calibration result is displayed:

i) Press the lit the Arrow button to confirm.


11) Calibrate the Level detector (Air detector) (BM 5).
Equipment needed: Drip chamber, Pressure meter, Calibration tube set.
a) Start the AK 200 S / AK 200 ULTRA S dialysis machine and enter the service
menu, Calibr / BM.

3 Maintenance manual
b) Set the display to:

c) Press the Start UF Stop button to enter calibration routine.


d) Insert a filled drip chamber. It is recommended that both the water and the
drip chamber have a temperature of 37 C. Make sure that the level detector
(Air detector) and drip chamber are dry and clean. The drip chamber shall be
from the same type of blood line as used during treatment.
e) Apply a pressure of 100 mmHg ( 10 mmHg), to the venous drip chamber.
Use the pressure meter as reference.

NOTE!
When creating a positive pressure in the venous drip chamber, a more
treatment like condition is simulated as the pressure inside the drip chamber
becomes approximately the same as the venous pressure during treatment.
The purpose is to get a better contact between the chamber and the air
detector head, which results in a higher calibration value.

f) Wait for 2 minutes and then press the lit Arrow button
g) The calibration is now performed automatically and the calibration factor is
written into the EEPROM.
h) The calibration result is displayed:

The value under LEVEL is the new alarm limit, which shall be 50 or higher.
The value under TRANSMIT is the transmission level, which is normally 255
but can also be 160, if the air detector is exceptionally good.

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Maintenance manual 53
12) Measure the voltage between TP 23 and TP 24 on the BM CPU board. (See
figure below.)
Exchange battery B1 if the value is below 2.6 V.
Note! The machine must be switched on when measuring.

13) Control of the blood pump/substitution flow pump occlusion


3 Maintenance manual

Check surface on the roller at the pump rotor, if it is damaged exchange the
unit.
The roller unit should easily go back to upper end position when it has been
pressed down to end position. Exchange unit if it gets stuck in any position.

NOTE!
If the pump segment has a different wall thickness, the occlusion of the pump
must be adjusted to the correct wall thickness.

Use the gauge pins (stop/go) available in the kit K40158001. The kit includes
following three different gauge pins:
T = 1.1 (Stop pin = 1.1x2x0.7 = 1.5mm)
T = 1.6 (Stop pin = 1.6x2x0.7 = 2.2mm)
T = 2.0 (Stop pin = 2.0x2x0.7 = 2.8mm)
T = wall thickness of the tubing
Use following formula to calculate which gauge pin to use: 2 x wall thickness x 0,7
(mm)

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54 Maintenance manual
Adjustment instruction
Check the range between the pump rollers and the path according to the picture
below. Adjust range between the pump rollers and the path if it is necessary.

The GO pin should barely pass within the calibrating area.


The STOP pin is NOT allowed to pass in any point within the calibrating area.

3 Maintenance manual
NOTE!
Put grease on the GO and STOP pins when not used and store the pins in a
plastic ba to prevent them from corroding.

14) Enter Service / Calibr / BM and set the AK 200 S / AK 200 ULTRA S display
to:

a) Press the Start UF Stop button to start calibration routine.


b) Make sure that nothing is connected to the transducer (zero pressure)
c) Check zero level of the System Pressure Transducer. Tolerance: 5 mmHg.
Calibrate if necessary (see chapter Calibration manual for details).

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Maintenance manual 55
15) Enter Service / Calibr / BM and set the AK 200 S / AK 200 ULTRA S display
to:

a) Press the Start UF Stop button to start calibration routine.


b) Make sure that nothing is connected to the transducer (zero pressure)
c) Check zero level of the Arterial Pressure Transducer. Tolerance: 5 mmHg.
Calibrate if necessary (see chapter Calibration manual for details).
3 Maintenance manual

16) Enter Service / Calibr / BM and set the AK 200 S / AK 200 ULTRA S display
to:

a) Press the Start UF Stop button to start calibration routine.


b) Make sure that nothing is connected to the transducer (zero pressure)

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c) Check zero level of the Venous Pressure Transducer. Tolerance: 5 mmHg.
Calibrate if necessary (see chapter Calibration manual for details).

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17) Enter Diagnose / BM / Pumps and check that the blood pump(s) stops when the
cover is opened.

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18) Start the blood pump(s) and let it run at lowest possible speed. Open the blood
pump cover and place a magnet (1) on the sensor for the cover. Stop the blood
pump rotor by manually grabbing the handle (2). Check that the power to the
blood pump motor is switched off within 2 seconds.
3 Maintenance manual

19) Enter Service / Calibr / FM and set the AK 200 S / AK 200 ULTRA S display
to:

a) Press the Start UF Stop button to start calibration routine.


b) Disconnect a tube to achieve zero pressure (see picture).
c) Check zero level of the Degassing Pressure Transducer. Tolerance: 5
mmHg.
Calibrate if necessary (see chapter Calibration manual for details).

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20) Enter Service / Calibr / FM and set the AK 200 S / AK 200 ULTRA S display
to:

a) Press the Start UF Stop button to start calibration routine.


b) Disconnect a tube to achieve zero pressure (see picture).
c) Check zero level of the Flow Output Pressure Transducer. Tolerance: 5
mmHg.
Calibrate if necessary (see chapter Calibration manual for details).

3 Maintenance manual
21) Enter Service / Calibr / FM and set the AK 200 S / AK 200 ULTRA S display
to:

a) Press the Start UF Stop button to start calibration routine.


b) Disconnect a tube to achieve zero pressure (see picture).

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c) Check zero level of the Flow Input Pressure Transducer. Tolerance: 5
mmHg.
Calibrate if necessary (see chapter Calibration manual for details).
3 Maintenance manual

22) Enter Service / Calibr / FM and set the AK 200 S / AK 200 ULTRA S display
to:

a) Press the Start UF Stop button to start calibration routine.


b) Disconnect a tube to achieve zero pressure (see picture).
c) Check zero level of the High Pressure Guard Transducer. Tolerance: 5
mmHg.
Calibrate if necessary (see chapter Calibration manual for details).

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23) Enter Service / Calibr / FM and set the AK 200 S / AK 200 ULTRA S display
to:

a) Press the Start UF Stop button to start calibration routine.


b) Disconnect a tube to achieve zero pressure (see picture).
c) Check zero level of the Dialysis Fluid Pressure Transducer. Tolerance: 5
mmHg.
Calibrate if necessary (see chapter Calibration manual for details).

3 Maintenance manual
24) Enter Service / Calibr / FM and set the AK 200 S / AK 200 ULTRA S display
to:

a) Press the Start UF Stop button to start calibration routine.


b) Disconnect a tube to achieve zero pressure (see picture).

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Maintenance manual 61
c) Check zero level of the Saftey Guard Pressure Transducer. Tolerance: 5
mmHg.
Calibrate if necessary (see chapter Calibration manual for details).
3 Maintenance manual

25) If installed: Calibrate the pH-sensor (FM 13) with a buffer solution. (see chapter
Calibration manual for details).
26) Check the blood leak detector limits: 0 and 100 10.
a) Remove the blood leakage detector cover and clean the inside of the blood
leakage detector housing.
b) Mount a blood leakage calibration cover (K40169001). Make sure that the
filter is in horizontal position.
c) Enter the Service menu.
d) In service mode, select calibration, FM, intern and Blood Leakage Detector
(FM 24).
e) Let the machine stabilize at 37 C. No concentrate shall be used.
f) Press the Start UF Stop button to enter the blood leakage calibration routine.
g) Check the blood leak detector limits 0 and 100 10. Calibrate if necessary
(see chapter Calibration manual for details).
h) Drain the AK 200 S / AK 200 ULTRA S dialysis machine and remount the
standard blood leakage cover.
i) Enter the Service menu.
j) In service mode, select calibration, FM, intern.

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27) Check the water level in the heating vessel, should be approximately 1 cm above
the centre line (at the centre of the vessel according to the figure below), adjust if
necessary.

3 Maintenance manual
28) Check the conductivity indications, at approximately 14 mS/cm.
Place A-pick up tube in concentrate container and let it stabilise for 15 minutes.
Use GXL fluid monitor screen and a reference instrument connected to the
dialysis fluid tubes.
The indicated conductivity values in GXL should correspond to the indication on
the reference instrument. The maximum deviation is 0.1 mS/cm.
29) Check the temperature indications, at approximately 37 C.
Use GXL fluid monitor screen and a reference instrument connected to the
dialysis fluid tubes.
The indicated temperature value (at the conductivity cell 2, guard) should
correspond to the indication on the reference instrument. The maximum deviation
is 1.5 C.
If the deviation is more than the stated tolerance; the affected temperature
transducer must be exchanged.
30) Place A-pick up tube back into the heating vessel and wait for 5 minutes. Place
the B-pick up tube in the concentrate container. Enter Service menu, Calibr /
FM / Other / UF / Restr. Perform an FRN calibration.
31) Let the machine pass Fch. Check the DC leakage between TP 7 (Z0VL) on the
Power distribution board and the earth point on the back plate. Measure in DC
Voltage, should be < 1 V.
32) Check the DC leakage between TP 7 (Z0VL) on the Power distribution board and
the cover on the Degass pump motor. Measure in DC Voltage, should be < 1 V
33) Check the DC leakage between TP 7 (Z0VL) on the Power distribution board and
the Degass pump head. Measure in DC Voltage, should be < 1 V.
34) Check the DC leakage between TP 7 (Z0VL) on the Power distribution board and
the cover on the Flow Out pump motor. Measure in DC Voltage, should be < 1 V.
35) Check the DC leakage between TP 7 (Z0VL) on the Power distribution board and
the Flow Out pump head. Measure in DC Voltage, should be < 1 V.
36) Check the DC leakage between TP 7 (Z0VL) on the Power distribution board and
the cover on the Flow In pump motor. Measure in DC Voltage, should be < 1 V.

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Maintenance manual 63
37) Check the DC leakage between TP 7 (Z0VL) on the Power distribution board and
the Flow In pump head. Measure in DC Voltage, should be < 1 V.
38) If ULTRA: Calibration of internal pressure regulator.
Equipment needed: Pressure reference instrument, Calibration tube set.
a) Let the machine pass the functional check.
b) Press the Fluid flow button and set the main flow to 500 ml/min.
c) Activate HDF or HF.
d) Press the Pressure control button for 3 seconds until lit.
e) Connect the dialyzer coupling to the conductivity cell on the pressure
reference instrument.
f) Adjust venous pressure to +100 mmHg. Check that TMP is approximately
+150 mmHg.
g) Connect a tube between the substitution fluid port and the external pressure
3 Maintenance manual

reference instrument.
h) Press the Fluid bypass button to obtain main flow through the pressure
regulator.
i) Adjust the pressure regulator to +55 mmHg 5 mmHg. To get a correct
reading, the reference instrument and the test tube must be at same height
as the substitution fluid port.
j) Press the Fluid bypass button and remove the pressure reference
instrument and tube.

39) Perform a simulated treatment according to following instruction:


If the BVS is installed, switch it on.
The machine must be in volume control.
Insert a filled venous drip chamber in the level detector.

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64 Maintenance manual
When the Priming button is flashing, simulate a venous pressure of
approximately 50 mmHg.
Insert the BVS test tool, K22281001.
Set the UF-volume to 0.9 and treatment TIME to 1:00 h.
Connect a T-piece to the dialysis tubings. Put the end of the tube in a
measuring glass filled with more than 1 l of water, approx. 37 C .
Press the Fluid bypass button. Check that the tube to the measuring glass is
filled with water and all air bubbles are evacuated.
Set the blood pump speed to 200 ml/min, press the Priming button and start
the blood pump.
Press the UF-rate button and set priming UF rate and minimum UF-rate to 0.0
l/h.
Make sure the measuring glass is filled to 1.00 l adjust if necessary.

NOTE!
It is very important to do the following things (A, B and C) more or less
simultaneously i.e. within seconds.

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A: Simulate blood in the priming detector.
B: Make sure (again) that the measuring glass is filled to 1.0 l.
C: Press the Start UF Stop button.
D: Press the flashing TMP button when UF rate is approximately at set value
(check bargraph).
Make sure that the blood pump is not stopped by any alarm during this test
since this may affect the accumulated UF volume. All kind of fluid alarms
(conductivity etc.) have to be avoided.

Check the residual volume at TIME = 0:00


- Approved residual volume: 100 ml 50 ml.
- Approved difference between actual UF volume and UF Supervision volume
is 120 ml.
The BVS test tool simulates a hemoglobin value within the range 60 160 g/l.
When inserted into the BVS unit it is possible to check the switch, that a reference
value is taken and that a graph is shown on the information display when the BVS
button is pressed.
The value for relative blood volume will be approx. 0% with some deviations. Do
note that the blood flow must be more than 180 ml/min for 5 minutes before a
reference value is taken.
40) If installed: Back-up battery Capacity-test
Conditions for the test:
The back-up batteries must be fully charged, e.g. the mains plug must have
been connected to mains and the mains switch on the power supply must
have been on, for at least 24 h before this test is to be done. The charge
indicator on the power supply is lit when the AK 200 S / AK 200 ULTRA S
dialysis machine is equipped with back-up batteries.
Continue the simulated treatment from step 39. The blood pump must be
running during this test.
Fill the measuring cylinder with 1 l of water.
a) Disconnect the mains plug.

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Maintenance manual 65
b) Let the machine run in simulated treatment for at least 15 minutes.
Following attention will be given.

c) After 15 minutes, re-connect the mains plug.

NOTE!
After the Capacity-test the machine has to be re-charged. After 24 h the back-up
batteries are fully re-charged.

If the machine stops within 15 minutes, re-connect the mains plug and the
backup-batteries must be exchanged. Before the machine turns off following
attention will be given.
3 Maintenance manual

41) Check that the overload protection on the heparin pump is working.
42) Check the arterial clamp by attaching the calibration tube set into the arterial
clamp. Enter priming mode and create a level detector alarm to get the clamp
closed. Apply a pressure of 600 mmHg. Check that the pressure does not fall
more than 30 mmHg in 15 seconds.
43) Check the venous clamp by attaching the calibration tube set into the venous
clamp. Enter priming mode and create a level detector alarm, by lowering the level
in the drip chamber, to get the clamp closed. Apply a pressure of 600 mmHg.
Check that the pressure does not fall more than 30 mmHg in 15 seconds.
44) Connect the mains plug to the outlet supply of an electrical safety tester.
Perform the Earth Leakage Test (ELT) and the Patient Earth Leakage Test (PLT)
according to instructions available in Electrical safety inspection for AK-machines.
45) Perform heat/chemical disinfection.

3.3.2 Supplementary A-kit

3.3.2.1 Parts in the Supplementary A-kit


The A-kit is designed to be used as a complementary addition to the Base-kit for the
preventive maintenance procedures of AK 200 S / AK 200 ULTRA S dialysis machine.
The A-kit (K40166002) includes following exterior parts:
Step Monitor Denomination Part no. Qty
1 FM Pick-up tube (red) K13467002 1
2 FM Pick-up tube (blue-white) K13467001 1
3 FM complete dialyzer tubing blue K40373001 1
4 FM complete dialyzer tubing red K40374001 1
5 FM Non-return valve K17978001 1
6 FM Washer, blood pump rotor K07316001 4

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66 Maintenance manual
NOTE!
All parts in the A-kit are possible to exchange without opening the dialysis machine.

3.3.2.2 How to exchange the exterior parts included in the A-kit


Procedure

1) Change the pick-up tube A (red).

3 Maintenance manual
2) Change the pick-up tube B (blue-white).

3) Change the complete dialyzer tubing blue.

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Maintenance manual 67
4) Change the complete dialyzer tubing red.

5) Change the non-return valve on the water


3 Maintenance manual

inlet tube.

6) Add/change the washers for the blood


pump rotors.

3.3.2.3 Actions to carry out after the parts have been exchanged
Procedure
1) First perform a heat disinfection program. Refer to the AK 200 S or
AK 200 ULTRA S Operators Manual.

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68 Maintenance manual
2) After the heat disinfection; re-tighten the nuts of the dialyser connector set to the
machine.
3) Let the machine pass Fch.
A leakage test of the dialyser connector set is performed in state 24.
4) Control of the blood pump/substitution flow pump occlusion
Check surface on the roller at the pump rotor, if it is damaged exchange the
unit.
The roller unit should easily go back to upper end position when it has been
pressed down to end position. Exchange unit if it gets stuck in any position.

NOTE!
If the pump segment has a different wall thickness, the occlusion of the pump
must be adjusted to the correct wall thickness.

Use the gauge pins (stop/go) available in the kit K40158001. The kit includes
following three different gauge pins:

3 Maintenance manual
T = 1.1 (Stop pin = 1.1x2x0.7 = 1.5mm)
T = 1.6 (Stop pin = 1.6x2x0.7 = 2.2mm)
T = 2.0 (Stop pin = 2.0x2x0.7 = 2.8mm)
T = wall thickness of the tubing
Use following formula to calculate which gauge pin to use:
2 x wall thickness x 0,7 (mm)

Adjustment instruction
Check the range between the pump rollers and the path according to the picture
below. Adjust range between the pump rollers and the path if it is necessary.

The GO pin should barely pass within the calibrating area.


The STOP pin is NOT allowed to pass in any point within the calibrating area.

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Maintenance manual 69
NOTE!
Put grease on the GO and STOP pins when not used and store the pins in a
plastic bag to prevent them from corroding.

3.3.3 Supplementary B-kit

3.3.3.1 Parts in the Supplementary B-kit


The B-kit is designed to be used as a complementary addition to the Base-kit for the
preventive maintenance procedures of AK 200 S / AK 200 ULTRA S dialysis machine.
The B-kit (K40167001) includes following overhaul parts:
Step Monitor Denomination Part no. Qty
1 FM Spike kit BiCart and SelectCart cartridge holders K21557006 2
(PEEK lower)
2 FM Complete valves: FOVA, DIVA, TAVA, BYVA, K15235A 8
DRVA BCVA, TPVA, PBVA
3 Maintenance manual

3 FM Recirculation valve (complete) K15514002 1


4 FM Silicon tube (3 x 2 mm) 100312032 7m
4 FM Silicone tube 2 x 1.5 100312166 1m
5 FM Santoprene tube 100312141 2m
6 BM Venous pressure line (complete) K21353A 1
7 BM Arterial pressure line (complete) K15145001 1
8 BM System pressure line (complete) K21358A 1
9 BM Pump tube (air pumps) K22114001 3
9 BM Strap (air pumps) 100314015 3

3.3.3.2 How to exchange the overhaul parts included in the B-kit


Procedure

1) Change the lower complete spike house


and O-rings in the BiCart and SelectCart
cartridge holders. Assemble according to
machine configuration.

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70 Maintenance manual
2) Change following complete valves: FOVA,
DIVA, TAVA, BYVA, DRVA, BCVA,TPVA
and PBVA.

3) Change complete Recirculation valve.


4) Change all the Silicone tubes in the fluid
monitor.
5) Change all the Santoprene tubes in the
fluid monitor.

3 Maintenance manual
6) Change the (complete) venous pressure
line.

7) Change the (complete) arterial pressure


line.

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Maintenance manual 71
8) Change the (complete) system pressure
line.

9) Change the pump tubes for the air pumps.


Clean the rollers with ethanol (70%).
3 Maintenance manual

3.3.3.3 Actions to carry out after the parts have been exchanged
Procedure
1) Perform a heat disinfection program. Refer to the AK 200 S / AK 200 ULTRA S
Operators Manual.
2) Let the machine pass Fch with BiCart Select concentrate.

3.4 Defibrillator use

3.4.1 Test after defibrillator use


A defibrillator is electrical equipment which is intended to stimulate a patients heart
during a heart failure by means of an electrical shock. The electrical output from the
defibrillator is high energy pulses. This electrical shock may disturb/destroy any
equipment connected to the patient.
If a heart condition should occur during dialysis, it is a matter of seconds and there
might not be time enough to disconnect the dialysis equipment.
AK 200 S / AK 200 ULTRA S dialysis machine has been designed according to state of
the art also when it comes to immunity to electrical and radio disturbances. But since
there are several parameters that may vary, for instance different types of defibrillators,
the settings for the defibrillator (50 - 400 Joule), skin resistance, blood and dialysis
fluid conductivity and so on, it is not possible to give an accurate estimation of how
much the defibrillator will affect the AK 200 S / AK 200 ULTRA S dialysis machine.
According to 60601-1 clause 6 the machine is not defibrillator safe.

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72 Maintenance manual
The result of using a defibrillator while AK 200 S / AK 200 ULTRA S dialysis machine is
connected to a patient may be one of the following:
No or minor disturbances in the operation of AK 200 S / AK 200 ULTRA S dialysis
machine.
Disturbances that will cause a technical restart.
Technical breakdown of some components in AK 200 S / AK 200 ULTRA S dialysis
machine.
It is recommended that any AK 200 S / AK 200 ULTRA S dialysis machine that has
been connected to a patient during defibrillation is immediately disconnected from the
patient after the defibrillation. After such an incident the AK 200 S / AK 200 ULTRA S
dialysis machine shall be checked by a service technician according to below:

3.4.2 Actions, test after defibrillator use


DC leakage tests according to Section 3.3.1.3 Actions to carry out after the parts
have been exchanged on page48

3 Maintenance manual
Earth Leakage Test (ELT) and Patient Leakage Test (PLT) according to Section 9
Electrical Safety Inspection on page189
Complete functional check.

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Maintenance manual 73
4 Replacements
4.1 General ........................................................................................................................ 75

4.2 Replacement of components .................................................................................... 75


4.2.1 Change actions........................................................................................................ 75

4.3 Replacement of Batteries .......................................................................................... 77


4.3.1 List of batteries in AK 200 S and AK 200 ULTRA S dialysis machines
............................................................................................................................ 77
4.3.2 Battery and electronic waste handling .................................................................... 77

4.4 Replacement of power supply cord........................................................................... 77

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74 Replacements
4.1 General
The actions to carry out after a component replacement in
AK 200 S / AK 200 ULTRA S dialysis machines are brought together in the combined
Blood Monitor and Fluid Monitor Replacement Matrix found in the Components section
of the AK 200 S / AK 200 ULTRA S Spare Part List, MHCEN9288 revision 03.2016 or
later.
The numbers in the matrix show which actions and in which order they will be done. It
is important that the actions are done and in correct order.
This information is a guideline for service technicians, which actions to perform when a
component has been replaced.
A list of all actions and explanations how to execute them is found further on in this
chapter.

NOTE!
If the fluid path has been opened for troubleshooting, a heat disinfection must be
performed before the machine is ready for next treatment.

4.2 Replacement of components

4.2.1 Change actions


Adjust Inlet Pressure Regulator
Adjust inlet pressure regulator according to Service Manual chapter Calibration
manual.
BVS test with tool K22281001

4 Replacements
Perform actions according to instructions in the Maintenance manual.
Calibrate BiCart Select Control and Protective Pump
Calibrate according to calibration instructions in the Service Manual chapter
Calibration manual.
Calibrate BiCart Select Level Detector
Calibrate according to calibration instructions in the Service Manual chapter
Calibration manual.
Calibrate Blood Leak Detector
Calibrate according to calibration instructions in the Service Manual chapter
Calibration manual.
Calibrate Conductivity Cell A
Calibrate according to calibration instructions in the Service Manual chapter
Calibration manual.
Calibrate Conductivity Cell B
Calibrate according to calibration instructions in the Service Manual chapter
Calibration manual.
Calibrate FRN
Calibrate according to calibration instructions in the Service Manual chapter
Calibration manual.
Calibrate Internal Pressure Regulator (AK 200 ULTRA S)
Calibrate according to calibration instructions in the Service Manual chapter
Calibration manual.
Calibrate Level Detector (Air detector)
Calibrate according to calibration instructions in the Service Manual chapter
Calibration manual.

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Replacements 75
Calibrate pH
Calibrate according to calibration instructions in the Service Manual chapter
Calibration manual.
Calibrate Pressure Transducer
Calibrate according to calibration instructions in the Service Manual chapter
Calibration manual.
Calibrate Priming Detector
Calibrate according to calibration instructions in the Service Manual chapter
Calibration manual.
Check BPM
Check according to BPM test instructions in the Service Manual, chapter
Maintenance manual.
Check Conductivity Value
Check conductivity value according to hospital laboratory.
Check/Load Program (GXD)
Perform actions according to instructions in Service Manual chapter Maintenance
support description. Download new program version.
Clean the Machine from Calcium and then from Proteins and Fat
Perform actions according to Operators manual.
ELT test
Perform the Earth Leakage Test (ELT) according to instructions available in chapter
Electrical safety inspection for AK-machines.
Functional Check (Fch)
Start the machine and let it perform a Fch.
4 Replacements

Heat Disinfection
Perform a heating according to the Operator's Manual.
I2C scan
Perform actions according to Service Manual chapter Maintenance support
description, Diagnostic Flow diagram, FM.
LED-test
Perform a LED test of the operators panel according to Service Manual, chapter
Maintenance Support Description, see Section 5.2.1 Available test procedures on
page89.
Load Preset file
Perform actions according to instructions in Service Manual chapter Maintenance
support description.
Occlusion
Calibrate according to calibration instructions in the Service Manual chapter
Calibration manual.
PET test
Perform the Protective Earth Test (PET) according to instructions available in
chapter Electrical safety inspection for AK-machines.
PLT test
Perform the Patient Earth Leakage Test (PLT) according to instructions available in
chapter Electrical safety inspection for AK-machines.
Set Time & Date
Set time and date according to instructions in the Service Manual, chapter
Maintenance support description.

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76 Replacements
Simulated Treatment
Simulate a treatment according to instructions in Service Manual chapter
Maintenance manual.
Test Clamp according to the Maintenance Manual
Test the clamps according to instructions in the Service Manual, chapter
Maintenance manual.
Total Default Preset
Perform actions according to instructions in Service Manual chapter Maintenance
support description.

4.3 Replacement of Batteries

4.3.1 List of batteries in AK 200 S and AK 200 ULTRA S dialysis


machines
The following batteries are present in AK 200 S and AK 200 ULTRA S dialysis
machines:
Description Type Location
Battery to real time clock, 3V CR2025 Below the buzzers at the BM CPU
Lithium board, B1
Battery for power failure alarm, 9V HR6F22 BM
NiMH
Battery backed memory, SRAM BR1632 BM CPU board. IC 65, IC10.
Battery back-up during power LC-R127R2PG1 Below bottom tray on the monitor
failure, 12V, Rechargeable Lead stand

4 Replacements
battery

4.3.2 Battery and electronic waste handling


Separate collection for electrical and electronic equipment.

Waste handling
Batteries from AK 200 S and AK 200 ULTRA S dialysis machines shall not be
discarded in normal waste, instead separate and proper collection systems must be
used. If improperly disposed, batteries might contaminate the environment and risk the
health of people.

NOTE!
Follow local legislation applicable for Battery and electronic waste handling.

4.4 Replacement of power supply cord


To replace the power supply cord, use your thumbs to open the safety latch (retaining
clip), replace the power supply cord, and then close the safety latch.

NOTE!
For safety reasons, always order the new power supply cord from Gambro.

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Replacements 77
5 Maintenance support description
5.1 Operator's panel .......................................................................................................... 80
5.1.1 Buttons and displays ............................................................................................... 80
5.1.2 Treatment overview ................................................................................................. 81
5.1.2.1 Blood and fluid paths ........................................................................................... 81
5.1.2.2 Parameter buttons ............................................................................................... 82
5.1.2.3 Bargraph displays................................................................................................ 82
5.1.3 Stand-by group ........................................................................................................ 82
5.1.3.1 Stand-by group buttons ....................................................................................... 82
5.1.3.2 Alarm buttons ..................................................................................................... 83
5.1.4 Display and setting group ........................................................................................ 83
5.1.4.1 Overview.............................................................................................................. 83
5.1.4.2 Viewing trends on the screen ............................................................................. 83
5.1.4.3 Colours in parameter displays ............................................................................ 84
5.1.5 Light intensity adjustment ....................................................................................... 85
5.1.6 Light intensity on old panels .................................................................................... 85
5.1.6.1 Bargraph contrast ................................................................................................ 85
5.1.6.2 Backlight .............................................................................................................. 86
5.1.7 Treatment overview screen .................................................................................... 86
5.1.8 Functional check overview screen .......................................................................... 88

5.2 Maintenance support overview .................................................................................. 89


5.2.1 Available test procedures ........................................................................................ 89
5.2.2 Access the Maintenance Support Selection ........................................................... 89
5.2.3 To Exit ..................................................................................................................... 89
5.2.4 Logging mode.......................................................................................................... 89
5.2.4.1 Logging mode overview....................................................................................... 89
5.2.4.2 Logging mode flow diagram ................................................................................ 90
5.2.5 Arrays ...................................................................................................................... 91
5.2.6 AK 200 S dialysis machine Flow path with S-variables ....................................... 92
5.2.7 AK 200 S UFD dialysis machine Flow path with S-variables ............................... 93
5.2.8 AK 200 ULTRA S dialysis machine Flow path with S-variables ........................... 94
5.2.9 Logging diagram, S-variables for BM ..................................................................... 95

5.3 How to enter/exit Service/Preset mode ..................................................................... 96


5.4 Preset mode ................................................................................................................. 96
5.4.1 Custom setting......................................................................................................... 96
5.4.2 Configuration .......................................................................................................... 97
5.4.3 PC Preset ................................................................................................................ 98
5.4.4 Others...................................................................................................................... 98
5.4.4.1 Language version ................................................................................................ 98
5.4.4.2 Time settings ....................................................................................................... 99
5.4.4.3 Total default ........................................................................................................ 99
5.4.5 Start up mode ........................................................................................................ 100
5.4.6 Preset of concentrates .......................................................................................... 102

5.5 Service mode ............................................................................................................. 105


5.5.1 How to enter service mode.................................................................................... 105
5.5.2 Service mode flow diagram .................................................................................. 106

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78 Maintenance support description
5.5.3 Blood monitor flow diagram, calibration ................................................................ 107
5.5.4 Fluid monitor flow diagram, calibration ................................................................. 108
5.5.5 Diagnostic flow diagram ....................................................................................... 109
5.5.6 Error Buffers flow diagram .................................................................................... 110
5.5.7 Diagnostics BM ...................................................................................................... 111
5.5.8 Diagnostics FM ..................................................................................................... 112
5.5.9 Utility flow diagram ............................................................................................... 113
5.5.10 Exalis flow diagram ............................................................................................. 114
5.5.11 Download new program version ............................................................................ 115
5.5.11.1 Tools needed ..................................................................................................... 115
5.5.11.2 Download software ............................................................................................ 115

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5.1 Operator's panel

5.1.1 Buttons and displays


Below follows a short presentation of the operator's panel. This is intended for the
service technicians use. If you want a more detailed information about all buttons and
their functions see Operator's manual.
The panel consists of a number of buttons and displays. These can be divided into six
logical groups:
1. Hygiene group
These buttons are used to select machine modes mainly related to disinfection,
rinsing and draining of the fluid monitor.
2. Mode group
The buttons in this group are used to select different treatment modes.
3. Therapy group
These buttons are used to initiate priming, select heparin data and special
treatment therapies. The HF button is only available for AK 200 ULTRA S dialysis
machine.
4. Treatment overview group
This group graphically shows the status of the treatment and allows for a complete
overview of all important treatment parameters.
5. Stand-by group
These buttons can be used for direct control and stand-by of certain functions.
6. Display and setting group
The four buttons and the set knob are used for setting of all parameters except the
blood flow. The flow is always directly controlled with the Blood flow knob. The
information is shown on the information display.
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Figure 5-1. AK 200 S Operator's panel

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Figure 5-2. AK 200 ULTRA S Operator's panel

5.1.2 Treatment overview

5.1.2.1 Blood and fluid paths


Shows graphically the status of the treatment with the displays and the flow pictures.
This allows for a complete overview of all important treatment parameters within a few
seconds.
1-2 Blood path
The blood path lights up red when the priming detector detects blood.
3-5-7 Bypass path

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The bypass path is orange when the dialysis fluid is not correct. When the fluid is
correct, the path is green.
3-4-6-7 Dialyzer path
The dialyzer path is green when dialysis fluid passes through the dialyzer.

6-7 Ultrafiltration path


The ultrafiltration path is yellow during isolated ultrafiltration and fluid bypass
situations.

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Figure 5-3. Flow diagram

5.1.2.2 Parameter buttons


Setting of a parameter can generally be described as follow:
Procedure
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1) Press the selected parameter button. The actual information will be displayed on
the information display.
2) Set the value with the Set knob, (select set value or alarm limits by pressing the
appropriate Arrow button).

5.1.2.3 Bargraph displays


The Bargraph displays operate as follows:
Red bars for alarm limits.
Yellow bars for actual value.
Green bars for set value.

5.1.3 Stand-by group

5.1.3.1 Stand-by group buttons


These buttons are used to start and stop the treatment and in alarm situations.
Is used to start and stop the blood pump.

Is used to silence the buzzer. The buzzer will only be silenced for 30 seconds if the
alarm persists.

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Is used to bypass the dialysis fluid.

Is used for initiation and termination of treatment. It should normally not be pressed
during treatment.

5.1.3.2 Alarm buttons


The alarm indicators are situated on the right side of the flow picture and only lights up
in alarm situations. When a button flashes it is a request for the operator to press the
button. Information will then be showed on the information display.
Buzzer signal is combined with attention message. Attention from the operator is
required. When the Technical alarm button is lit and buzzer sounds a technical fault
has occurred.
Enter Logging, choose Errors and read the displayed information. This information
consists of different error codes, described in the Error Code List, ordering no.
HCEN9313. The buzzer will be silenced with the Audio pause button.

5.1.4 Display and setting group

5.1.4.1 Overview
The information display and the four buttons together with the Set knob, are used for
displaying and setting of all parameters except the blood flow. The blood flow is always
directly controlled with the Blood flow knob.

5.1.4.2 Viewing trends on the screen


Pressing a parameter button, e.g. Cond will display the parameters set value(s) and

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limits in the lower part of the display. The top part will display a graph of the parameter
as trend, i.e. the last 20 minutes.

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1.
Information display goes blank after 15 seconds, unless Hold is pressed.
2. Blood flow knob; activates the blood flow display
3. Hold; If pressed when the information display is lit, the display is held forever. If
pressed again, the display disappears.
4. Set knob; changes a selected value
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5.1.4.3 Colours in parameter displays


The colours in the bargraphs are also used in the texts in the information display. The
top line is black.

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5.1.5 Light intensity adjustment
NOTE!
The description below is only valid for operators panels with the symbol in the
upper left corner of the overlay. For older panels see Section 5.1.6 Light
intensity on old panels on page85.
If the panel has the symbol , it is possible to find out the software version of
the panel. In the beginning of functional check, when F.CH (capital letters) is
displayed, press the Blood flow knob and the Set knob simultaneously. The
software version of the panel will then be displayed in the time display.
It is possible to adjust the light intensity for 9 different LED groups separately. The
groups are:
Blue buttons
LCD screen
Bargraphs
Orange fluid flow lines
Yellow fluid flow line
Green fluid flow lines
Red blood flow lines
Time display
Red buttons
To adjust the light intensity, do as follows:
Procedure
1) Enter BM calibration in Service mode. For instructions on how to enter service
mode, see section Service mode on page 5:33.
2) Turn the Blood flow knob to find Panel Intensity (BM 10), and select it by

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pressing the Start UF Stop button.
3) The following is shown:

4) Use the Arrow buttons below Prev. and Next to navigate between LED groups.
5) The currently selected LED group will be lit, and its intensity value will be shown in
the time display.
6) Use the Set knob to adjust the light intensity of the currently selected LED group.
7) To exit the Panel Intensity menu, press the Hold button.

5.1.6 Light intensity on old panels

5.1.6.1 Bargraph contrast


The contrast for bargraphs is adjustable:

Bargraphs
With a dark display, keep the middle Arrow button (SET) depressed to light up the
display.

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Turn the Set knob until the contrast is optimal. The setting is automatically stored
(permanently).

5.1.6.2 Backlight
There is a possibility to adjust a back light for the push-buttons on the front panel.
Press SET and then LOW push-buttons. When LOW button being pressed (keep it
pressed), the SET button can be released. After 3 seconds the display will lit up. Keep
the LOW button pressed and adjust the back light with the Set knob.

5.1.7 Treatment overview screen


When no other screen is displayed on the information display, the Treatment overview
screen will be displayed at all times during treatment. On this screen, the operator can
obtain an overall picture of parameter values, valid at that time, for the on-going
treatment. All parameters are measured values except sodium and bicarbonate
concentrations which are set values.
If desired, the Treatment overview screen can be removed by preset and in that case
the left Arrow button is to be pressed to display the screen when the information
display is unlit.
The picture below shows an example of the Treatment overview screen:
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Figure 5-4. Treatment overview screen for AK 200 S dialysis machine

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Figure 5-5. Treatment overview screen for AK 200 ULTRA S dialysis machine

Table 5-1. Parameters shown on Treatment overview screen


Qb current blood flow rate
Pa current arterial pressure
Pv current venous pressure

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Qbacc accumulated blood volume
Ps current system pressure
UFR current ultrafiltration rate
UFV accumulated ultrafiltration volume (patient weight loss)
accumulated ultrafiltration volume (patient weight loss) as percentage
of the set value
TMP current transmembrane pressure
Vinf accumulated infusion volume
Rinf current infusion rate
Na+ sodium concentration (set value)
HCO3 bicarbonate concentration (set value)
BV relative blood volume from measurement start (BVS)
time of latest measurement check (BPM, Diascan, AFM)

SYS systolic blood pressure (BPM)


DIA diastolic blood pressure (BPM)
pulse rate (BPM)

K latest measured clearance value (Diascan)


Kt/V latest measured Kt/V value (Diascan)
time to target is estimated to be within the remaining treatment time set
(Diascan)
Qa latest measured access blood flow rate

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5.1.8 Functional check overview screen
The Functional check overview screen will be displayed on the information display
during the functional check of the machine. The screen gives the operator information
about how long the functional check has been in progress and also what is being
tested at that moment.
The ticks to the right of each test show that the test has been successfully performed.
The green field on the progress bar shows the successfully performed part of the
functional check. The time in minutes at the bottom of the screen shows elapsed time
of the functional check.
If desired, the Functional check overview screen can be removed by preset and in that
case the Technical alarm button is to be pressed to display the screen when the
information display is unlit.
The picture below shows an example of the Functional check overview screen:
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Figure 5-6. Functional check overview screen

Table 5-2. Tests shown on Functional check overview screen


Fch_BM functional check of the blood monitor
Fch_FM functional check of the fluid monitor, this position is the main test, tests
below are more detailed and included in this
mS/cm test of the conductivity cell
mS/cm test of the conductivity cell
C test of the temperature sensor
C test of the temperature sensor
mmHg leakage test of the fluid monitor
FRN test of UF supervision system
FRN test of UF supervision system
BiCart priming of the BiCart cartridge

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5.2 Maintenance support overview

5.2.1 Available test procedures


The Maintenance support section is intended to be used by qualified service
engineers, when performing different service related procedures of the machine. It is
possible to:
Perform a LED-test of the Operators Panel. When the Arrow button below
LED-test is pressed all buttons will remain lit.
Perform logging of different parameters when trouble shooting the machine. In
Logging mode it is possible to check the condition and the status of both the
hardware and the software.
Perform a Technical Error logging.
Enter Preset/Service-mode (via an access code).

5.2.2 Access the Maintenance Support Selection


The Maintenance support is accessed by simulataneously pressing the three Arrow
buttons below the screen at the same time for 3 seconds.

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5.2.3 To Exit
Press the Hold button to exit from Maintenance Support.

5.2.4 Logging mode

5.2.4.1 Logging mode overview


In the Logging mode it is possible to check the condition and the status of both the
hardware and the software.
There are three types of logging facilities, internal logging (Intern), External logging
(Extern) and technical error logging (Errors).
The actual information is shown on the information display, which can be divided into
different sections (0 - 2). To look at two or three different parameters simultaneously,
use the possibility to select a separate field on the information display for each
parameter.

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5.2.4.2 Logging mode flow diagram
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5.2.5 Arrays
When you press the Arrow button below "Arrays" and then turn the Set knob you will
find a number of different codes.
The arrays used for service purpose are:
SRI SRL SRR SRB
SRW SP SF

The different letters stands for:


First letter:
S: Service logging parameters

Second letter:
R: RAM variable
P: Process
F: Function

Third letter:
B: Byte (0-25)
I: Integer (whole numbers)
L: Logic (True / False)
R: Real (floating point numbers)
W: Word (0-65535)

Use the Set knob when you select arrays and press the Hold button when you want to
step backwards.
When it is necessary to look at two or three different arrays at the same time, use the
possibility to choose a separate field on the information display for each data.

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Summary:
1. Set field
2. Set array
3. Set index
4. Set format
5. Press the Hold button twice
6. Press the Arrow button below "Display" and you receive text with a value on a
given section.

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5.2.6 AK 200 S dialysis machine Flow path with S-variables
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5.2.7 AK 200 S UFD dialysis machine Flow path with S-variables

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5.2.8 AK 200 ULTRA S dialysis machine Flow path with S-variables
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5.2.9 Logging diagram, S-variables for BM
BM 202, S-variables

Venous blood pump Pump cover open = SRL (24)


Blood flow = SRI (84)
Arterial blood pump Pump cover open = SRL (25)

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Blood flow = SRI (83)
Level detector Level det. transmit level = SRB (0)
Level det. comparator level = SRB (89)
Priming detector High level = SRB (1)
Low level = SRB (2)
Blood = SRL (23)
Venous clamp Clamp active = SRL (2)
Clamp status = SRL (30)
Closed = SRL (34)
Arterial clamp Clamp active = SRL (28)
Clamp status = SRL (29)
Closed = SRL (33)
Venous pressure transducer SRI (1)
Arterial pressure transducer SRI (82)
System pressure transducer SRI (0)
BM board temperature SRI (17)
Blood volume sensor, BVS BVS on = SRL (104)
BVS installed = SRL (105)
Heparin pump Est. Acc. heparin volume (ml) = SRI (88)
Accumulated heparin volume (ml) = SRI (87)
Overload = SRL (26)
Heparin Fch check counter = SRI (98)

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5.3 How to enter/exit Service/Preset mode
NOTE!
Only service engineers fulfilling the minimum level of competence, according to
AK 200 S / AK 200 ULTRA S Service manual, "Competence of Service
Engineers" are allowed to enter the Service/Preset-mode to repair or maintain
AK 200 S / AK 200 ULTRA S dialysis machines in the field.
The access code (XX, YY, ZZ) to enter Service/Preset mode is available via your
local Gambro Service representative.

To enter Service / Preset mode, press the Arrow button below ServPres and you will
be asked to set the service code:

Set the code with the Set knob (two digits for each button). If you do not press the
Arrow buttons within 30 seconds, restart from the first figure is required.

NOTE!
The remaining time must be set at 0.00 before the presetting can start.
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Select the desired mode by pressing the Arrow button below this mode.
To exit from Service or Preset mode, press the Hold button below Fch.
AK 200 S / AK 200 ULTRA S dialysis machine will restart and perform a functional
check, Fch.

5.4 Preset mode

5.4.1 Custom setting


In Preset mode, it is possible to customise the AK 200 S / AK 200 ULTRA S dialysis
machine. For more information, contact Gambro service.
The choices are listed below:
Machine configuration
PC - preset program
Language version for the display
Time settings
Total default

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Start up mode
Preset of concentrates

Select Preset.

NOTE!
All preset values and limits must be verified before treatment start.
Preset concentrates must be verified by laboratory test of the dialysate produced
by the AK 200 S / AK 200 ULTRA S dialysis machine.
Preset for pump segments must be verified by comparing the pumped volume
and a reference volume.

5.4.2 Configuration
Procedure
1) Choose the Arrow button below Config to select unit.

Config - Configuration
PC Pres - Preset with PC

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Others - Language, clock and defaults

2)

3) To configure the unit, turn Set knob and confirm by pressing the Arrow button
below REF SET.

4) Press the Start UF Stop button to store the configuration.


This procedure is applicable for the following alternatives:
pH (installed/not installed)
BM 200/202 (either)
System pressure transducer (installed/not installed)
BVS (installed/not installed)
RS 232 / RS 422 (either)
BPM (installed/not installed)
Diascan (installed/not installed)

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Access flow (installed/not installed)
Voltage (230 V/115 V)
5) To return, press the Hold button.

5.4.3 PC Preset
In this mode it is possible to preset several hundred parameters and start up values
with help of a PC and the GXP - Gambro eXternal Preset -program.
This set up is used for customising (within certain limits) AK 200 S / AK 200 ULTRA S
dialysis machine. For more information, contact Gambro service.

See separate manual for GXP.

5.4.4 Others

5.4.4.1 Language version


Procedure
1) Select the Arrow button below Others to set language, clock or defaults.
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2) Select the Arrow button below Language.

3) To select language, turn the Set knob. Select the button below REF SET. The
button will stop flashing and will then go out.

The following languages are available:


Czech
Danish
Dutch
English
Finnish
French
German

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Greek
Hungarian
Italian
Norwegian
Portuguese
Russian
Serbian
Spanish
Swedish
Turkish
Polish
Slovak
Slovenian
4) Press the Start UF Stop button to store the chosen language.
5) To leave the Language menu, press the Hold button.

5.4.4.2 Time settings


Procedure
1) Select the Arrow button below Others to set language, clock or defaults.

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2) Choose the Arrow button below Clock.

To set year/day of the week select the left Arrow button, to set month and day
select the middle Arrow button and to set hour and minute select the right Arrow
button. Turn the Set knob to change the value, press Arrow button to confirm.
3) To save changes and show the chosen time, press the Start UF Stop button.

4) To leave the Clock menu, press the Hold button.

5.4.4.3 Total default


NOTE!
A total default will change all customize presets to the standard factory settings.

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Procedure
1) Select the Arrow button below Others to set language, clock or defaults.

2) Choose the Arrow button below Default.

3) Press the Start UF Stop button to store the preset. This confirms that the
AK 200 S / AK 200 ULTRA S dialysis machine consists of a BM 200 without pH
monitoring or other options (standard AK 200 S / AK 200 ULTRA S dialysis
machine).
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4) To return, press the Hold button twice.

5.4.5 Start up mode

The start up values for AK 200 S / AK 200 ULTRA S dialysis machines are set in the
same way as other presets. Following values can be preset by pressing appropriate
button:
SN/DN, SP/DP
Default: DN, SP
Volume control/Pressure control
Default: Volume control
Heparin
Volume (10.0 - 30.0 ml) and length (31.0 -119.0 mm) of syringe.
Default: volume 30.0 ml, length 81.0 mm.
Time (start up)

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Default: 4.00
Venous pressure window
Default: mmHg, Low Level 0 Set 200 High Level 1000
Blood flow
Default: pump segment, mm
Alt1, 7.90 Alt2, 6.35 Alt3, 4.00.
Note that AK 200 S / AK 200 ULTRA S dialysis machine has to be in DN mode to
be able to adjust the blood line inner diameter and the blood pump has to be
stopped. For adjustment of the occlusion, please see the Calibration Manual.
SN data
Default: System press, mmHg LL 10 HL 175
Temp
Default: LL 35.0 C Set 37.0 C HL 39.0 C
Cond
Default in Acetate mode: 140 mmol/l
Default in Bicarbonate mode: Na=140 mmol/l HCO3=34 mmol/l
Arterial pressure window
Default: alarm limit, mmHg LL 0 Set 150 HL 2000
UF rate
Default: In TMP mode LL 0.00, HL 1.50
UF priming rate 0.10
Minimum UF rate 0.00
pH
Default:alarm limit Acetate, LL 6.0, HL 8.0

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Bicarbonate, LL 6.5, HL 7.8
Acetate / bicarbonate
Default: bicarbonate
Degassing pressure (bypass button)
Recommended degassing pressure according to the table below.
Default Acetate: mmHg LL -700, Set -630, HL -500
Default Bicarbonate: mmHg LL -700, Set -580, HL -500
Degassing pressure table
The degassing pressure can be preset between -500 to -700 mmHg. This is used
whenAK 200 S / AK 200 ULTRA Sdialysis machine is operating at high altitudes,
see table below.

Table 5-3. In acetate mode


Altitudes (m) Normal air pressure Recommended Water boiling
(mmHg) degassing pressure temperature (C)
(mmHg)
0 760 -630 100
500 710 -580 98.1
1000 663 -530 96.2
1500 620 -490 94.4

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Altitudes (m) Normal air pressure Recommended Water boiling
(mmHg) degassing pressure temperature (C)
(mmHg)
2000 580 -450 92.6
2500 540 -410 90.7

Table 5-4. In bicarbonate mode


Altitudes (m) Normal air pressure Recommended Water boiling
(mmHg) degassing pressure temperature (C)
(mmHg)
0 760 -580 100
500 710 -530 98.1
1000 663 -490 96.2
1500 620 -450 94.4
2000 580 -410 92.6
2500 540 -370 90.7

NOTE!
This variable is ignored if altitude preset, S550 is greater than 500 (m).

5.4.6 Preset of concentrates


Enter Preset mode.
To preset acetate concentrate, press the Acetate button.
To preset bicarbonate concentrate, press the Bicarbonate button.
The default presets are:
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Acetate: mmol/l and ions.


Liquid bicarbonate: mmol/l and molecules.
BiCart cartridge: mmol/l and ions.
Three different concentrates can be preset for acetate and bicarbonate. Following
example will show how to preset theAK 200 S / AK 200 ULTRA Sdialysis machine for
BiCart A-concentrate 201.
All values which are going to be set are specified at the label on the concentrate
containers.

NOTE!
If the values are present as both concentrated and diluted concentrate, use the
concentrated values.
Procedure
1) When the Bicarbonate button is selected, following will be displayed:

Select Concentrate.
2) Select where to store concentrate (alt 2).

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NOTE!
It is not possible to change Bicarbonate alternatives manually (alt.1). Please use
external preset.

3) Select mmol/l.

4) Select ion representation.

5) Push the Arrow button below select pos to set cursor.

6) Set cursor position at the digit which is going to be changed, with the Set knob. To

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confirm the cursor position, press the Arrow button below A: Na. . Set desired
value with the Set knob.

7) To confirm selected value and change cursor position, press Arrow button below
select pos. All values for the concentrate are set in this way.

8) When ready to continue with the next part in the concentrate, press Forw to
confirm the value, or step backwards by pressing Backw.

9) Choose Liquid or BiCart on the concentrate.

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10) When all the values for the concentrate are set, the display shows:

Turn the Set knob to change the character. Press the Arrow button below
selectchar.
11) Turn the set knob to change the cursor position. Press the Arrow button below
BiCart to change the selected character.

12) Press the Arrow button below Forw when the concentrate label is correct.

13) Press the Start UF Stop button to write preset parameters in EEPROM, or step
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backwards for change of values by selecting Backw.

NOTE!
Preset concentrates must be verified by laboratory test of the dialysate produced
by theAK 200 S / AK 200 ULTRA Sdialysis machine.

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5.5 Service mode

5.5.1 How to enter service mode

Press the Arrow button below Service to enter service mode.

Choose Calibration (Calibr), diagnostics (Diagnose) or utilities (Util) with the


appropriate button.
When you are in the service mode and want to step back, press the Hold button.
When you leave the Service mode, theAK 200 S / AK 200 ULTRA Sdialysis machine
will restart and perform a Fch (functional check).

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5.5.2 Service mode flow diagram
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5.5.3 Blood monitor flow diagram, calibration

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5.5.4 Fluid monitor flow diagram, calibration
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5.5.5 Diagnostic flow diagram

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5.5.6 Error Buffers flow diagram
Diagnostic error buffer
Sequential error buffer. 10 last errors are saved. Time from power on for each error is
also saved. Buffer is not cleared at power on. (see example below)
Transient error buffer
Transient error during buffer that affects treatment. 10 errors are saved. Buffer is
cleared at power on.
Permanent error buffer
Normal error buffer that affects treatment. 10 errors are saved. Buffer is cleared at
power on.
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5.5.7 Diagnostics BM

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5.5.8 Diagnostics FM
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5.5.9 Utility flow diagram
In utility it is possible to interrupt the chemical disinfection phase for service purposes.
This is only intendend to be used as a service tool.

WARNING!
Check that no disinfection solution has been taken in, if so a complete Chemical
rinse program must be performed.

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5.5.10 Exalis flow diagram
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5.5.11 Download new program version

5.5.11.1 Tools needed


It is possible to download software via the Ethernet connector at the FM power
distribution board, as a complement to the serial communication port. Tools needed:
PC.
Crossover twisted pair cable, 210220002.
GXD (version 1.30 or higher).

5.5.11.2 Download software


Procedure
1) Switch on the machine and enter Service/Util/Others/Exalis/Network.
2) At the computer:
Enter Start/Settings/Control Panel/Network Connections.
3) Right click at Local Area Connection and select Properties.
4) Scroll to Internet Protocol (TCP/IP).
5) Mark it and select Properties.
6) Tick the Use the following IP address.
7) Set an IP address in the same span as shown at the machine (default
192.168.0.200). Do not set the same number.
8) Use the default Subnet mask (255.255.255.0). Press OK.

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9) At the dialysis machine:


Enter bootload.
10) Connect the computer to the dialysis machines Ethernet connector. Use a
crossover twisted pair cable.

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11) At the computer:
Start GXD (version 1.30 or higher).
12) Set Ethernet as the Com Port.
13) Press Start.

14) A pop up dialog box will appear, select or set a group.


15) Set the machines IP address or select the address from the list. If a new IP
address is set, press Add. Select the IP address. Press OK.
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NOTE!
The download from computer to machine (IT Expansion board) takes
approximately 10 seconds.

16) A pop up dialog box will appear.

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17) If all bytes have been transferred, press OK.

The transfer of data from computer to IT Expansion board is now finished.


18) Disconnect the computer.

NOTE!
The transfer from IT Expansion board to dialysis machine, internally, will continue
and will take approximately 10 minutes in total. During this process boo will be
shown in the dialysis machines time display. When the process is ready the
dialysis machine will automatically restart and enter preset mode.

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6 Technical description
6.1 Introduction................................................................................................................ 120
6.1.1 General.................................................................................................................. 120
6.1.2 Main functions ....................................................................................................... 121
6.1.2.1 Overview............................................................................................................ 121
6.1.2.2 Quick preparation procedures ........................................................................... 121
6.1.2.3 Treatment flexibility............................................................................................ 121
6.1.2.4 Disinfection ........................................................................................................ 122
6.1.2.5 Options .............................................................................................................. 122
6.1.2.6 Others................................................................................................................ 122
6.1.3 Parameters ............................................................................................................ 122

6.2 Fluid Monitor, FM....................................................................................................... 123


6.2.1 Fluid Monitor.......................................................................................................... 123
6.2.2 FM flow diagram AK 200 ULTRA S dialysismachine ........................................ 124
6.2.3 Treatment .............................................................................................................. 125
6.2.3.1 Water intake....................................................................................................... 125
6.2.3.2 Concentrate ....................................................................................................... 125
6.2.3.3 Concentrate - FM............................................................................................... 126
6.2.3.4 BiCart Select System ...................................................................................... 126
6.2.3.5 Dialysis Fluid ..................................................................................................... 126
6.2.4 Design and Construction ....................................................................................... 129
6.2.5 FM valves .............................................................................................................. 134
6.2.6 Electrical circuit boards used in the fluid monitor .................................................. 136
6.2.6.1 Wiring ................................................................................................................ 136
6.2.6.2 FM CPU board................................................................................................... 136
6.2.6.3 FM Analog Distribution board ............................................................................ 139
6.2.6.4 FM Power Distribution board ............................................................................. 139
6.2.6.5 Blood leak Detector board ................................................................................. 139
6.2.6.6 Conductivity cell board ...................................................................................... 139
6.2.6.7 Blood pressure monitor board ........................................................................... 139

6.3 Blood Monitor, BM..................................................................................................... 140


6.3.1 Blood Monitor ........................................................................................................ 140
6.3.2 Treatment .............................................................................................................. 141
6.3.2.1 Double Needle Treatment - HD ......................................................................... 141
6.3.2.2 Single Needle Treatment ................................................................................... 142
6.3.2.2.1 Single Pump .................................................................................................. 142
6.3.2.2.2 Double pump ................................................................................................. 143
6.3.2.3 Double Needle Treatment ................................................................................. 144
6.3.2.3.1 Flow diagrams ............................................................................................... 144
6.3.2.3.2 HDF Low Volume........................................................................................... 144
6.3.2.3.3 HDF on line.................................................................................................... 144
6.3.2.3.4 HF on line ...................................................................................................... 145
6.3.3 Design and Construction ....................................................................................... 145
6.3.3.1 Level Detector (Air detector).............................................................................. 145
6.3.3.2 Batteries ............................................................................................................ 145
6.3.3.3 Blood Pump Unit................................................................................................ 145
6.3.3.4 BVS - Blood Volume Sensor.............................................................................. 145

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6.3.3.5 Drip Chamber Level Adjustment........................................................................ 146
6.3.3.6 Fan .................................................................................................................... 146
6.3.3.7 Heparin Pump Unit ............................................................................................ 146
6.3.3.8 Line Clamp Unit ................................................................................................. 146
6.3.3.9 Operator's Panel................................................................................................ 146
6.3.3.10 Pressure Transducers ....................................................................................... 146
6.3.3.11 Priming Detector................................................................................................ 147
6.3.3.12 BPM - Blood Pressure Monitor .......................................................................... 147
6.3.4 Electrical circuit boards used in the blood monitor ................................................ 148
6.3.4.1 Wiring ................................................................................................................ 148
6.3.4.2 BM Analog Distribution Board ........................................................................... 148
6.3.4.3 Jumpers on the BM Analog Distribution board .................................................. 148
6.3.4.4 Panel Control Board .......................................................................................... 148
6.3.4.5 Jumpers on the Panel Control Board ................................................................ 148
6.3.4.6 BM CPU Board .................................................................................................. 149
6.3.4.7 Jumpers on the BM CPU board......................................................................... 149
6.3.4.8 Connectors on the BM CPU Board.................................................................... 150
6.4 Power Supply............................................................................................................. 151

6.5 Monitor stand............................................................................................................. 152

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6.1 Introduction
6 Technical description

6.1.1 General
NOTE!
This chapter only describes AK 200 ULTRA S dialysis machine. Be aware of the
differences between AK 200 S and AK 200 ULTRA S dialysis machines and
therefore only use it as a reference!
The Gambro AK 200 ULTRA S System is intended for use as a single patient machine
to perform hemodialysis (HD), hemodiafiltration (HDF) and hemofiltration (HF).
The System is also intended for on-line preparation of substitution fluids (see below) to
be used in HDF and HF.

The AK 200 ULTRA S System comprises of two monitors; one blood monitor (BM 202)
and one fluid monitor (FM 202). The monitors are placed on a mobile stand (MS 200 or
MS 202). The blood monitor is designed to control and supervise the extracorporeal
blood circuit. Single needle treatment can in hemodialysis be performed with one
pump (double clamp function) or with two pumps. To prevent coagulation, heparin may
be administered by means of a heparin pump. Single needle treatment can be carried
out with one or two blood pumps. Double needle treatment is carried out with only one
blood pump. Hemofiltration or hemodiafiltration is only carried out in double needle
treatment. The second pump is acting as substitution pump in these modes.
Disposable lines are used for the blood and the substitution flow.
The fluid monitor is designed to produce the dialysis and substitution fluid at a desired
temperature, conductivity and pressure within given specifications. It shall supervise
the fluid and transport the fluid through the dialyzer. The fluid monitor maintains the
dialysis flow through the dialyzer/filter with controlled ultrafiltration or controlled TMP1.
When a fault occurs, the fluid monitor bypasses the dialyzer. The monitor also detects

1 TMP is defined as the difference Pb out - P d out + 18.4 mmHg, where Pb out is the venous drip chamber
pressure and Pd out is the pressure measured in the dialysis fluid where it enters the machine after the
dialyzer. The offset of 18.4 mmHg compensates for the vertical distance between the pressure sensors.

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blood leaks in the dialyzer. Both acetate and bicarbonate treatments can be

6 Technical description
performed.
The on-line production of substitution solution can be deactivated and the
AK 200 ULTRA S dialysis machine can be used for HDF with bags.
The dialysis fluid consists of water and concentrate. The fluid monitor operates either
in acetate or bicarbonate mode. In bicarbonate mode the monitor mixes dialysis fluid
from water and two concentrates: acid and bicarbonate. The mode is selected from the
operators panel.
When AK 200 ULTRA S dialysis machine is used to produce bicarbonate containing
dialysis fluid originating from non-liquid concentrates, it is designed and validated for
use with the BiCart system.
When AK 200 ULTRA S dialysis machine is used to produce sodium chloride
containing dialysis fluid originating from non-liquid concentrates, it is designed and
validated for use with the BiCart Select system, i.e. the SelectCart cartridge and
SelectBag concentrate.
The fluid monitor should be disinfected after every treatment. The AK 200 ULTRA S
dialysis machine is disinfected according to the Operators Manual, with either
chemical disinfectants or with heat disinfection.
The fluid monitor also includes a power supply and a heat exchanger.
The MS 200 includes pressure regulator, infusion stand, a double filter holder for two
ultrafilters and a bottom tray.
The system is operated from the operators panel located on the blood monitor. For
information about the use and function of the operators panel, see chapter
Maintenance support description, or the AK 200 ULTRA S Operators Manual.

6.1.2 Main functions

6.1.2.1 Overview
The AK 200 ULTRA S dialysis machine includes the following main functions.

6.1.2.2 Quick preparation procedures


Automatic self test
Presetable treatment parameters

6.1.2.3 Treatment flexibility


Standard or high-flux HD with ultrapure dialysis fluid
On-line HDF, with pre- or postdilution
On-line HF, with pre- or postdilution
On-line preparation of substitution fluid for HF and HDF
Adjustable dialysis fluid flow rate 300-700 ml/min
Profiling of Na+ and HCO3-, and UF
Designed for BiCart Select system
Blood volume measurement, BVS
SN/SP and SN/DP with low recirculation
Isolated UF

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6.1.2.4 Disinfection
6 Technical description

Chemical and heat disinfection


Automatic disinfection, integrated disinfection
CleanCart cleaning, decalcification, disinfection
Chemical disinfection memory

6.1.2.5 Options
pH 200 K18266001
Battery Backup K18614001 (24V)
Electrically adjustable stand, MS 200

6.1.2.6 Others
Automatic Power On Test
External Logging via PC, GXL
Presetting of system parameters (internal or via external PC)
Download of new software via PC, GXD

6.1.3 Parameters
System and treatment parameters can be set at five different levels (Table1).
Level Type of parameters Presetable by:
4 Treatment parameters Operator, nurse
3 Alarm limits and defaults Clinic's technician
2 New functions Gambro technician or Gambro
subsidiary
1 Adaptions Gambro Head office
0 Safety limits Fixed

For information about setting the parameters in level 2 and 3, see Section 5
Maintenance support description on page78.
For information about the use and functions of the parameters in level 4, see the
AK 200 ULTRA S Operators Manual.

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6.2 Fluid Monitor, FM

6 Technical description
6.2.1 Fluid Monitor

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6.2.2 FM flow diagram AK 200 ULTRA S dialysismachine
6 Technical description

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6.2.3 Treatment

6 Technical description
6.2.3.1 Water intake
Feed water passes via a pressure regulator, an inlet valve, a heat exchanger and an
ultra filter to a heating vessel. The ultra filter is continuously flushed with a certain flow,
approx. 50-100 ml/min. that goes directly to drain via a restrictor.
The feed water must fulfil the ASAIO and AAMI standards on feed water for dialysis
monitors. The pressure regulator reduces pressure to a maximum of 1 bar.
The temperature of the incoming water is raised a couple of degrees in the heat
exchanger. This reduces the power consumption of the heating elements.
The inlet valve (INVA) is normally open. The water level in the heating vessel is
regulated by means of a float valve in the bottom of the heating vessel. The float valve
is closed when the water level reaches maximum and is opened when it falls to
minimum. The flushing valve (FLVA), which is used during disinfection, is closed during
treatment.
A non-return valve, placed between the recirculation loop, in front of the return flush
valve (RFVA) and behind the inlet water valve (INVA) is used to enable disinfection of
the first ultra filter.
The temperature transducer in the heating vessel measures the water temperature
and controls the heating. The heating vessel has two heaters and a stirrer. The stirrer
is used to ensure a constant water temperature.
From the heating vessel the feed water passes via a filter and a restrictor to an
expansion chamber. The function of the restrictor is to produce the negative pressure
that is necessary for degassing the fluid. The bubbles are separated in the degassing
chamber. The recirculation is controlled by a stepping motor. The degassing restrictor
bypass valve (DRVA), which is used during disinfection, is closed during treatment.
Constant pressure in the expansion chamber and constant level in the degassing
chamber are maintained by means of the degassing pump and the recirculation valve.

6.2.3.2 Concentrate
The dialysis fluid is a mixture of water and acetate based concentrate. (Salt is added to
the water in order to prevent the essential salts in the blood from passing through the
membrane in the dialyzer into the dialysis fluid). Water and concentrate are mixed in
the expansion chamber.
The amount of concentrate is regulated by the feed pump (piston pump). The amount
of concentrate to be added is determined by measuring the conductivity of the fluid.
Conductivity is the ability of the fluid to conduct electricity. (The conductivity cell is used
to measure the conductivity of the fluid.) The conductivity depends on the dialysis fluid
temperature (approx. 1.8% per C). The temperature transducer in the conductivity cell
is used to measure the temperature of the fluid and as certain the correct conductivity
value (to compensate for temperature fluctuations).
If conductivity is outside the preset limits, the dialyzer is bypassed and the dialysis fluid
goes directly to the drain (the direct valve - DIVA - is closed and the bypass valve -
BYVA - is opened). This situation may arise if there is not sufficient concentrate, the
concentrate pick-up tube is not properly inserted in the concentrate container, the flow
through the tube is obstructed or the water supply is insufficient. The proportioning
bypass valve - PBVA - is closed during treatment. The PBVA is open during
disinfection. The reason for this is that there is an under pressure after the feeding
pump. When the fluid monitor is disinfected, the system can be quickly filled with
disinfectant if the PBVA is open.

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6.2.3.3 Concentrate - FM
6 Technical description

The FM can operate in either acetate mode or bicarbonate mode (selectable by the
operator). The concentrate (acetate) is fed in via the Binlet.
In bicarbonate mode two concentrates are used, referred to as A- and B-concentrates.
First the A-concentrate is mixed with water in the mixing chamber. The fluid then
passes to the expansion chamber, where the B-concentrate is added. The amounts of
concentrate are regulated with two feed pumps (piston pumps). The conductivity is
measured by means of two cells. The conductivity cell in unit 1 measures the
conductivity at the first stage. The second cell measures conductivity after the B
component has been added.

6.2.3.4 BiCart Select System


The BiCart Select system is a concept for preparing the A- and B-concentrate in
bicarbonate dialysis treatments.
The A-concentrate is prepared on-line during the treatment from the SelectBag
container, containing the small electrolytes in a highly concentrated solution, and from
the dry sodium chloride cartridge, SelectCart.
The bicarbonate concentrate is continuously prepared from the dry bicarbonate
powder contained in the BiCart cartridge. The BiCart Select system improves
transportation, storage and handling efficiency. It introduces a possibility for
individualized sodium and bicarbonate concentrations, independent from the
prescribed concentrations of the small electrolytes.
The control system feeds the contents of the SelectBag container in a volumetric
proportion (1:200) to the dialysis fluid flow rate.
The flow of sodium chloride solution from the SelectCart cartridge is controlled using
the ordinary A-step control loop but the B-step is unchanged.
The use of AK 200 ULTRA S dialysis machine with BiCart Select system is equal to the
use of standard treatments with one exception:
Select concentrates do not run with any canister bicarbonate but only with BiCart
cartridge.
The correct proportioning of the minor electrolytes is monitored by the protective pump
and an infrared level detector. The level detector consists of an IR-LED and an IR
transistor placed on a fluid chamber.
A saturated solution of sodium chloride (NaCl) is produced from dry salt contained in
the SelectCart cartridge.
Both components are mixed on-line to produce the A-concentrate. The mixing of this
acidic concentrate with water is conductivity controlled.
Bicarbonate concentrate is produced separately by means of the BiCart cartridge. Its
mixing is also conductivity-controlled.
The final supervision of the dialysis fluid is performed by an independent conductivity
cell.
PAVA and PBVA are open during the priming of the SelectCart and the BiCart
cartridges.

6.2.3.5 Dialysis Fluid


The dialysis fluid is forwarded by the degassing pump (gear-wheel pump) to the
bubble trap. The restrictor and the flow pump produce a negative pressure (approx.
-600 mmHg), that separates the air from the fluid. The air is led from the degassing

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chamber back to the heating vessel (there is atmospheric pressure in the degassing

6 Technical description
chamber). The flow pump is also used to regulate the fluid level in the degassing
chamber. The level is monitored by a level detector.
It is very important that the dialysis fluid should have the correct conductivity. It is very
important that the system is able to detect if an incorrect concentrate is being used.
The pH sensor (optional) is used as an improved safeguard against faulty and/or
incorrect concentrates. (There is some disinfection solutions that can give correct
conductivity. But these solutions do normally not have the correct pH value.) If the
concentrate pick-up tubes are incorrectly inserted, this will also produce an incorrect
pH value.
After the pH-sensor there is a flow reducer and a bypass valve (FOVA). The function of
the flow reducer is to create a negative pressure.
The main flow is variable between 300 and 700 ml/min.
The bypass valve FOVA (closed during treatment) is used in disinfection mode. The
flow through the dialyzer is controlled by means of two pumps: flow output pump and
flow input pump (gear-wheel pumps). The function of the pumps is to maintain a
constant flow, to and from the dialyzer.
Treatment can be either volume controlled (UF) or pressure controlled (TMP). The
mode is selected from the operators panel.
In both UF and TMP mode, a variable main flow (300 - 700 ml/min) to the dialyzer is
obtained by means of the flow output pump. The pressure over the flow reducer is
adjustable, and thereby, a variable main flow is obtained.
Constant flow after the dialyzer is obtained by means of the flow-input pump. The input
flow is normally higher than the output flow. Dialysis patients are water retentive and
the excess is removed during treatment. The UF rate is a measure of the quantity
removed. If the output flow is 500 ml/min, the input flow may, for example, be 502
ml/min. In UF mode, the differential flow from the UF measuring cell and the required
UF rate (selected by the operator) is used to regulate the flow input pump so that the
desired pressure is obtained. After the flow input pump there is a positive pressure.
In TMP mode, TMP is used to regulate the flow input pump. The UF measuring cell is
used to measure the UF rate, but the measuring cell is not involved in the regulation of
the flow input pump.
Every 30 minutes during treatment, the UF measuring cell is automatically calibrated to
ensure correct performance. (This has to be done because waste products in the fluid
returned from the patient may be deposited in layers on the inside of the measuring
channels.) The calibration can be divided into three phases. During phase 1 the UF
measuring system is calibrated. During phase 2 the UF measuring unit and the
dialyzer are bypassed, i.e. there is no fluid passing through neither of the two channels
(DIVA, TAVA, and BYVA valves are closed and ZEVA valve is open). Thus the offset of
the two measurement channels can be measured.
Finally during phase 3 the dialysis fluid bypasses dialyzer but passes through the UF
measuring unit, i.e. the same amount of fluid is passing through both channels of the
UF measuring cell (DIVA, TAVA, and ZEVA valves are closed and BYVA valve is
open).
With channel 1 as a reference, channel 2 can be calibrated. The UF rate is now zero.
Calibration takes totally about 60 - 90 seconds. Treatment is then resumed.
After the UF measuring cell there is a pressure transducer (high-pressure guard) which
is activated if the pressure before the dialyzer becomes too high. For example, if there
is a blockage somewhere in the tubes, the high pressure guard is activated, the flow is
stopped and the system goes into bypass mode (see below).

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The bypass unit includes high-pressure guard and two valves: the direct valve (DIVA)
6 Technical description

and bypass valve (BYVA). The direct valve is normally open during treatment (if the
temperature, pressure, conductivity etc. are within the predefined limits). In an
emergency situation (e.g. in the event of a blood leak being detected), the direct valve
is closed and the bypass valve is opened. The dialysis fluid is led past the dialyzer
directly to the drain. The following situations result in a bypass:
Blood leak detected
Temperature out of limits
Conductivity out of limits
pH alarm (optional)
Technical error message
From the direct valve (DIVA) the dialysis fluid is forwarded to a second ultra filter and
further on through an infusion-outlet-port, a pressure regulator and the clean water
valve (CWVA).
The infusion line set is connected to the infusion outlet-port to access the infusion
solution.
The solution is forwarded to a single use filter. The integrity of this sterile filter has
been tested (for every filter) during manufacturing.
The pressure regulator is used to always maintain a positive fluid pressure (approx.
+50 mmHg) to ensure that the infusion line segment does not collapse during
operation.
The filter valve (FIVA), closed during treatment, is used for disinfection of the second
ultrafilter.
From the clean water valve (CWVA) the dialysis fluid is passed on to the dialyzer or in
bypass mode to drain.
In hemofiltration mode (HF mode) the clean water valve (CWVA) is always in bypass
mode but for hemodialysis mode (HD mode) or hemodiafiltration mode (HDF mode) it
may operate in both modes. The dialysis fluid is forwarded to the dialyzer via the
output tube.
From the dialyzer the dialysis fluid (mixed with waste products) is returned to the fluid
monitor via the input tube. The input tube nipple is fitted with a filter.
The taration valve (TAVA) is normally open. During the UF measuring cell calibration,
the taration valve is closed.
The zero setting valve (ZEVA) is normally closed. During the UF measuring cell
calibration phase 2, the zero setting valve is open.
The pressure transducer, Pd, measures the dialysis fluid pressure. The measurement
is used in the calculation of the TMP. The pressure transducer also activates an alarm
if the pressure becomes too high.
The dialysis fluid is fed to the bubble trap. The function of the bubble trap is to
separate air from the fluid. For example, a leakage may occur in the dialyzer. When
the fluid level in the bubble trap reaches the minimum level, i.e. when there is too
much air in the vessel, the evacuation valve (EVVA) is opened and the air is released.
The fluid level is monitored with a level detector.
The blood leak detector detects any blood in the dialysis fluid. In the event of the
slightest leak between the blood side and dialysis fluid side of the dialyzer, an alarm
will be activated. If blood is detected, the system goes into bypass mode. The
emptying valve (EMVA), which is closed during treatment, is used to empty the blood
leak detector when treatment is completed.

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Finally, the dialysis fluid is led to the drain via the flow-input pump and heat exchanger.

6 Technical description
6.2.4 Design and Construction
Following section describes the sub-units, the valves and the electrical boards used in
the fluid monitor.

1. Internal Pressure Regulator


2. Blood leak Detector
The blood leak detector, which uses light absoption, includes the following
components:
Housing with cover.
Transmitter board.
Receiver board.
Blood leak detector board.
The transmitter and receiver boards are connected to the blood leak detector
board. The blood leak detector board interfaces directly to the distribution board,
via a board connector.

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3. Pump Unit 3 (flow in)
6 Technical description

The fluid monitor contains three pump units. Each pump unit includes the
following:
Gear wheel pump.
Pressure transducer with board.
The pressure transducer is connected to the transducer board, via a twisted
cable. The transducer board interfaces directly to the distribution board, via a
board connector.
Output restrictor bypass valve, FOVA (flow output pump), evacuation valve,
EVVA (flow input pump), DRVA (degassing pump).
4. Pump Unit 2 (flow out)
see above
5. Pump Unit 1 (degassing)
see above
6. Particle Filter
7. Degassing Chamber
Both the degassing chamber and the deairating chamber have the function to
separate air from the dialysis fluid. Each degassing- and deairating chamber
contains a level detector.
8. Heating Vessel Unit
The heating vessel unit contains the following:
Heating vessel.
2 heating rods with over heating guard.
Temperature transducer (PT 100) with temperature transducer board. The PT
100 transducer is connected to the transducer board, via a twisted cable. The
transducer board interfaces directly to the FM Analog Distribution board, via a
board connector.
Float valve.
Water level guard.
Stirrer with 12 V DC-motor.
2 pick-up tube detectors.
9. Bypass Unit
The bypass unit includes the following:
Direct valve - DIVA.
Bypass valve - BYVA.
High Pressure Guard
The high-pressure guard is a pressure transducer with a board. The pressure
transducer is connected to the transducer board, via a twisted cable. The
transducer board interfaces directly to the distribution board via a board connector.
10. Concentrate pick-up tube connections
11. High Pressure Guard
12. UF Measuring Unit
The UF measuring unit consists of a measuring cell and two printed circuit boards.
They are mounted on each side of the measuring cell. The UF measuring unit
interfaces directly to the main board, via a flat cable.

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13. Deairating Chamber

6 Technical description
Both the degassing chamber and the deairating chamber have the function to
separate air from the dialysis fluid. Each degassing- and deairating chamber
contains a level detector. The deairating chamber also contains a pressure
transducer. The pressure transducer is used to measure the dialysis fluid pressure.
The pressure transducer is connected to the transducer board, via a twisted cable.
The transducer board interfaces directly to the distribution board, via a board
connector.
14. Safety Bypass Unit
The safety bypass unit includes the following: Safety pressure transducer with
board. The pressure transducer is connected to the transducer board, via a twisted
cable. The transducer board interfaces directly to the distribution board, via a
board connector.
15. Infusion Port
16. Diascan
With the use of a conductivity sensor, placed after the dialyzer in the fluid path, it is
possible to measure clearance during treatment. The used method for estimation
of urea clearance has been verified by urea clearance derived from blood samples
during dialysis and has proved to provide comparable accuracy.

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6 Technical description

1. Conductivity Cells
2. Level Detector
3. Control Pump
4. Protective Pump
5. Feeding Pump A
The fluid monitor contains two feeding pumps. Each pump unit consists of a piston
pump driven by a stepping motor.
6. Feeding Pump B
The fluid monitor contains two feeding pumps. Each pump unit consists of a piston
pump driven by a stepping motor.
7. Mixing Chamber
Water and concentrate are mixed in the mixing chamber.
8. Top Priming Chamber
9. Heat exchanger
The temperature of the incoming water is raised a couple of degrees in the heat
exchanger. This reduces the power consumption of the heating elements. The
heat exchanger is located on the back plate of the AK 200 ULTRA S dialysis
machine.
10. Reducer Unit
11. Air Collect Chamber

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6 Technical description
1.Relay Unit
2.pH-sensor (optional)
3.BPM (optional)
4.Run Time Meter
5.Power Distribution Board
6.FM CPU Board
7.Blood Pressure Nipple
8.External connections
See Installation Guide
9. Power supply
10. FM Fan
Dialyzer Connections
The input tube nipple is fitted with a particle filter.
Water Inlet Unit
The water inlet unit includes two valves: inlet valve - INVA - and flushing valve - FLVA.

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6.2.5 FM valves
6 Technical description

BCVA - BiCart Valve


Used during BiCart cartridge priming and top priming.
BYVA - Bypass Valve
Normally closed during treatment. Opens to let the fluid bypass the dialyzer in alarm
situations. The BYVA is closed during the zero flow phase in the UF self-calibration
and open during the differential flow phase.

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CWVA - Clean Water Valve

6 Technical description
In hemofiltration mode (HF mode) the clean water valve (CWVA) is always in bypass
mode but for hemodialysis mode (HD mode) or hemodiafiltration mode (HDF mode) it
may operate in both modes. The dialysis fluid is forwarded to the dialyzer via the
output tube.
DIVA - Direct Valve
Normally open during treatment. Closes in alarm situations. Closed during UF-cell
self-calibration.
DRVA - Degass Resctriction Valve
Open during heat disinfection to prevent the fluid system from boiling by bypassing the
degassing restrictor.
EMVA - Emptying Valve
Three-way valve. Used to facilitate the emptying the blood leak detector.
EVVA - Evacuation Valve
Special three-way valve, only one of the house halves has a seat. From the functional
point of view it works like an ordinary open/close valve. Opens when the level in the
deairating chamber drops below its low limit to let out air from the chamber.
FIVA - Filter Valve
The filter valve (FIVA), closed during treatment, is used for disinfection of the second
ultrafilter.
FLVA - Flush Valve
Open during disinfection for flushing the upper part of the heating vessel.
FOVA - Flow Output bypass Valve
Open during heat disinfection to prevent the fluid system from boiling by bypassing the
flow out restrictor.
HDVA - HD/HDF Valve
INVA - Inlet Valve
The inlet valve is normally open to let water into the heating vessel. It is closed in
following situations:
1. If the water level in the heating vessel is too high.
2. In disinfection mode (except when the system is flushed).
LDVA - Level Detector Valve
The level detector is used in the protective system for supervision of the SelectBag
concentrate flow.
PAVA - Priming A Valve
Open during the priming of the SelectCart and the BiCart cartridges.
PBVA- Proportion Bypass Valve
Open in chemical disinfection when filling up. Opens during BiCart priming.
Recirculation Valve
Proportional valve (three-way valve) controlled by stepper motor. Part of the degassing
level regulation.
RFVA- Return Flush Valve

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Technical description 135
Open during disinfection for recirculation of water.
6 Technical description

TAVA- Taration Valve


The taration valve (TAVA) is normally open. During the UF measuring cell calibration,
the taration valve is closed.
TPVA- Top Priming Valve
Used during top priming.
ZEVA- Zeroing Valve
The zero setting valve (ZEVA) is normally closed. During the UF measuring cell
calibration phase 2, the zero setting valve is open.

6.2.6 Electrical circuit boards used in the fluid monitor

6.2.6.1 Wiring
For a detailed description how to connect all cables in AK 200 ULTRA S dialysis
machine, see Section 10 Wiring diagram on page199:
Wiring Diagram FM 200 S, K20583
Wiring Diagram BM 200 S, K20595
Following is a brief functional description of each board in the fluid monitor.

6.2.6.2 FM CPU board


The FM CPU board controls most functions in the fluid monitor of AK 200 ULTRA S
dialysis machine. The CPU board consists of two major parts, the control system and
the protective system.
The main CPU in the control system is CPU F that controls I/O. The protective system
consists of three Echelon nodes that communicate through the protective system
Echelon bus. The FM CPU board is connected to the BM CPU board through the two
Echelon buses and the safe bus. The safe bus is a current loop that if interrupted sets
the machine in a patient safe state. The connection with the BM CPU board is done
through the Power Distribution Board FM.
Inputs and outputs
P1 is a 60 pin connector connected to the Analog Distribution Board. Input signals
from temperature transducers, conductivity cells, pressure transducers and blood leak
detector. Output signals to blood leak detector and I2C-EEPROMs. Power: +5, +12,
-12 and +24 V.
P2 is a 40 pin connector connected to I/O. Input signals from pH transducer, water
vessel low level detector and tube sense A and B. Output signals to I2C-EEPROMs,
valves, degassing motor, restrictor stepper motor and stirring motor. Power: +5 and
+24 V.
P3 is a 50 pin connector connected to I/O. Input signals from heaters off detector and
BiCart latch status detector. Output signals to valves, conductivity 1 and 2 stepper
motor, flow motor in and out and heaters. Power: +24V.
P4 is a 20 pin connector connected to the UFM Preamplifier Board. Input signals:
preamplified UF-measure signals. Output signals: UFFQ (UF frequency) and signals to
an I2C-EEPROM. Power: +5, +12, -12 and +24 V.
P5 is a 10 pin connector connected to I/O. Input signal from Bicart trap low level
detector. Output signals to valves. Power: + 24 V.

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P6 is a 40 pin connector connected to Select units. Input signals from control and

6 Technical description
supervision pump synchronization detectors, supervision level detector, SelectCart
cartridge latch status detector and SelectBag container position detector. Output
signals to control and supervision pumps, supervision level detector and valves.
Power: +5 V and +24 V.
P7 is a 4 pin connector connected to the I2C-EEPROM at the run time meter. Signals:
CAD0 and CAC0. Power: +5 V.
P8 is a 2 pin power connector connected to the Power Distribution Board FM. +24 V is
supplied in this connector.
P9 is a 20 pin connector connected to the Power Distribution Board FM. Input signals
from an external RS232 interface and from the Blood Pressure Monitor, BPM. Output
signals to the external RS232 interface, to the BPM and to the FM fan. Bi-directional
signals are the Echelon bus signals CEDA, CEDB, PEDA and PEDB and SBSI that
connects the safe bus between FM and BM. Power: +5 V.
P10 is a 10 pin expansion connector for the protective Echelon bus. Signals: PEDA
and PEDB. Power: +5, +12 and -12 V.
P11 is a 10 pin expansion connector for the control Echelon bus. Signals: CEDA and
CEDB. Power: +5, +12 and -12 V.
P12 is a 4 pin optional I/O connector. TIN1 and TIN2 are input signals. Power: +5V.
P13 is a 10 pin analog test connector used in production. Five analog signals are
connected to this connector.
P14 is a 2 pin connector connected to the deairating ultrasonic level transducer.
P15 is a 2 pin connector connected to the degas ultrasonic level transducer.
P16 is a 4 pin optional +24 V output connector.
P17 is a 20 pin connector for protective node Q used for emulation. The reset and the
service pin of the neuron chip are connected to P17 together with the 11 I/O pins.
Power: +5 V.
P18 is a 20 pin JTAG test connector. Signals are the five JTAG test signals connected
to the FPGA and 8 further signals that can be used for test of the FPGA. Power: +5V.
P19 is a 20 pin connector for the Select supervision node used for emulation. The
reset and the service pin of the neuron chip are connected to P19 together with the 11
I/O pins. Power: +5 V.
P20 is a 20 pin connector for the control communication node used for emulation. The
reset and the service pin of the neuron chip are connected to P20 together with the 11
I/O pins. Power: +5 V.
P21 is a 20 pin connector for the protective flow restrictor node used for emulation.
The reset and the service pin of the neuron chip are connected to P21 together with
the 11 I/O pins. Power: +5 V.
P22 is a 20 pin connector for the Select control node used for emulation. The reset
and the service pin of the neuron chip are connected to P22 together with the 11 I/O
pins. Power: +5 V.

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6 Technical description

Jumpers on the FM CPU board


J1 Short-circuiting causes the protective node Q
to send a service message
J2 Short-circuiting resets the protective node Q
J3 The jumper, connected to the FPGA, can be
used for test purpose
J4 Short-circuiting resets the Select supervision
node
J5 Short-circuiting resets the control
communication node
J6 Short-circuiting causes the control
communication node to send a service
message
J7 Short-circuiting causes the Select supervision
node to send a service message
J8 Short-circuiting resets the protective flow
restrictor node
J9 Sets CPU F, OB and P in boot load mode
ready to receive new software
J10 Short-circuiting resets the Select control node
J11 Short-circuiting causes the Select control node
to send a service message
J12 Short-circuiting causes the protective flow
restrictor node to send a service message

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6.2.6.3 FM Analog Distribution board

6 Technical description
This board is localized in the AK 200 ULTRA S fluid monitor, where its function is to
gather all the sensor signals to one cable that is connected to the main FM CPU
board. The devices that are connected on this board are:
Conductivity cells
All fluid pressure sensors
Blood leak detector
Temperature sensors
Dia connector sensors
Return flow valve RFVA
Feeding Pumps
Conductivity Measuring Unit
Water Inlet Unit
Top Priming Unit
The distribution board contains 13 board connectors, which are used to interface the
transducer boards. Three of the connectors are normally not used. The
temperature/pressure transducer and the transducer board must not be separated. If
the transducer is to be replaced, the transducer board must also be replaced (and vice
versa). It is important that the transducer boards are connected to the correct
distribution board connector. For example, board connector P22 must not be used for
any other transducer board than the dialysis fluid pressure transducer board.

6.2.6.4 FM Power Distribution board


The FM Power Distribution Board distributes power from the AC/DC unit to the fluid
monitor and the blood monitor in AK 200 ULTRA S dialysis machine and contains
control logic for four external interfaces. It connects the control system Echelon bus,
the protective system Echelon bus and the safe bus between the FM CPU board and
the BM CPU board. It also connects the Blood Pressure Monitor (BPM) to the FM CPU
board, supplies operating voltage to the running-time meter and distributes signals to
the FM fan.

6.2.6.5 Blood leak Detector board


The blood leak detector board is localized in the AK 200 ULTRA S fluid monitor where
it is a part of the blood leak detector. This detector measures the optical transmission
with a LED and a photo transistor. The LED current is controlled with this PCB and the
measured photo transistor current is converted to a voltage. Calibration values for the
detector are also stored on the board.

6.2.6.6 Conductivity cell board


This board is used to measure the conductivity of the dialysis fluid. It is designed with
two equally, completely separate, circuits in order to support the requirement of one
control and one protective system measurement. The conductivity cell board also
includes electronic for PT100 temperature sensors that are used for temperature
compensation of the conductivity measurement.

6.2.6.7 Blood pressure monitor board


The blood pressure monitor board is used in AK 200 ULTRA S dialysis machine when
an optional blood pressure monitor (BPM) is connected. It is designed to supply the
BPM with needed power supply. The Blood pressure monitor board is located between
the power distribution board and the BPM module.

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6.3 Blood Monitor, BM
6 Technical description

6.3.1 Blood Monitor

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6.3.2 Treatment

6 Technical description
6.3.2.1 Double Needle Treatment - HD
Following figure illustrates the flow diagram when the AK 200 ULTRA S dialysis
machine is used for double needle treatment.

Figure 6-1. Simplified Flow Diagram - Double Needle Treatment


The function of the arterial blood pump is to maintain the extra corporeal blood flow.
Blood is removed from the patient, forwarded to the dialyzer and then returned to the
patient. The blood flow (0 - 500 ml/min) is set by means of a knob on the operators
panel. In an alarm situation the blood pump is stopped.
The blood pump will not operate when the pump cover is open. In an alarm situation,
the blood can be returned to the patient manually. The blood pump has a handle that
can be pulled out and turned to return the blood.
The arterial line clamp is open during normal treatment. When an alarm is issued by
the air detector or the blood leak detector (in the fluid monitor) the clamp closes and
the blood pump is stopped. The arterial pressure transducer will issue an alarm if the
pressure becomes to low. For example, if the needle or arterial blood line is blocked,
an alarm will be given (the blood pump is stopped). The alarm is activated if there is an
increased negative pressure between the patient and the blood pump, e.g. a fall in
blood pressure, altered positions of the arterial needle, or a kink in the arterial line
between the patient and the blood pump.
The heparin pump is used for injection of heparin to the blood in order to inhibit
coagulation. An alarm is issued when the syringe reaches end of stroke or if the
heparin line is kinked.
The blood passes the Blood Volume Sensor before it enters the dialyzer. The BVS
gives additional information about the patients hydration status to the operator, by
providing information about the change in the apparent blood volume.
After the dialyzer there is a drip chamber with an air detector. If air is detected in the
blood or if the blood level in the drip chamber is too low, an alarm is issued and the
blood flow is stopped (the blood and heparin pumps are stopped and the line clamps
are closed). The drip chamber acts as an expansion chamber to even out pressure
pulsation. The level in the drip chamber is adjustable by means of a venous level
adjustment (the button on the front panel that is located to the left of the venous line
clamp).

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The venous pressure transducer measures the venous blood pressure. If the pressure
6 Technical description

is too low or too high, the blood flow is stopped (the blood and heparin pumps are
stopped and the line clamps are closed). Too high venous pressure may be caused by
an obstruction after the venous drip chamber or a change in the patients position. If
the venous pressure is too low, it could be caused by a line separation, an obstruction
before the venous drip chamber, a fall in blood pressure or a change in the patients
position.
The priming detector detects if there is blood in the venous blood line.
The blood is returned to the patient via the venous line clamp. The clamp is normally
open. But in the event of an alarm from the air detector, the venous pressure
transducer or the blood leak detector (in the fluid monitor), the line clamp clamps the
blood line and stops the blood flow.

6.3.2.2 Single Needle Treatment

6.3.2.2.1 Single Pump


Following figures illustrate the flow diagrams when the AK 200 ULTRA S dialysis
machine is used for single needle treatment.

Figure 6-2. Simplified Flow Diagrams - Single Needle Treatment - Single Pump
When the AK 200 ULTRA S dialysis machine is used for single needle-single pump
treatment, the arterial and venous phases are time- or pressure controlled.
Arterial blood is removed from the patient when the arterial line clamp is open and the
venous line clamp is closed. The running time of the arterial blood pump is determined
by the operator. In this way a positive pressure is created. In the next phase, the blood
pump is stopped, the arterial line clamp is closed and the venous line clamp is opened,
i.e. the blood is returned to the patient by means of the positive pressure.
The venous line clamp is then closed, the arterial line clamp is opened, the blood
pump is started and the procedure repeated. In single needle mode, the operator
defines the length of time the arterial and venous line clamps are to be open and
closed.
The expansion chamber evens out pressure pulsation. The blood level in the
expansion chamber is electrically adjustable from front panel.

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6.3.2.2.2 Double pump

6 Technical description
Figure 6-3. Simplified Flow Diagrams - Single Needle Treatment - Double Pump
When the blood monitor is used for single needle treatment, both blood pumps are
used. Note that the pumps are running in divergent directions.
The treatment is controlled by a predefined stroke volume, mean blood flow and by the
high limit on the system pressure transducer (extra).
The required mean blood flow and stroke volume is determined by the operator. When
the mean blood flow is affected, the venous and arterial blood pump will change its
speed. The venous pump is volume controlled.
The mean blood flow is set in the same way as the required blood flow in the double
needle treatment. When the SN button is pressed, the arterial blood pump will start
and will run until the expansion chamber is filled up (detected by the high limit on the
system pressure transducer). The venous blood pump then will start, and will run until
the predefined stroke volume has been returned to the patient. This is monitored by
the low limit on the system pressure transducer after the filter. The process is repeated
throughout treatment.
Since the two blood pumps run alternately, the drip chamber acts as an expansion
chamber to even out pressure pulsation.
The standard configuration includes three pressure transducers: arterial pressure
transducer, venous pressure transducer and system pressure transducer.

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6.3.2.3 Double Needle Treatment
6 Technical description

6.3.2.3.1 Flow diagrams

Figure 6-4. Simplified Flow Diagram - Double Needle treatment - post dilution

Figure 6-5. Simplified Flow Diagram - Double Needle treatment - pre dilution

6.3.2.3.2 HDF Low Volume


The BM 202 offers the possibility to perform low volume HDF in double needle mode
by using the venous pump for infusion. Maximum infusion rate is 2.0 l/h.

NOTE!
This mode can only be used if the AK 200 ULTRA S dialysis machine is used in an
non-online mode. See AK 200 ULTRA S Operators Manual for further information.

6.3.2.3.3 HDF on line


These simplified figures shows how the AK 200 ULTRA S dialysis machine is used for
HDF on-line treatment.

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The venous pump operates as infusion pump, taking infusion fluid from the infusion

6 Technical description
port on the FM, pumping it through an ultrafilter, into either the venous line
(post-dilution), or the arterial line (pre-dilution).
See AK 200 ULTRA S Operators manual for further information.

6.3.2.3.4 HF on line
When AK 200 ULTRA S dialysis machine works in HF on-line mode, the setup for the
lines are the same as for HDF, either pre- or post dilution can be used.
See AK 200 ULTRA S Operators manual for further information.

6.3.3 Design and Construction

6.3.3.1 Level Detector (Air detector)


The level detector consists of an ultrasonic transmitter and receiver mounted in one
unit. The transmitter is mounted on the right-hand side of the drip chamber and the
receiver is mounted on the left-hand side. Bubbles larger than 1 l will be trapped by
the drip chamber. An alarm will be issued if the blood level falls below the middle of the
level detector head.

6.3.3.2 Batteries
A 9-volt battery, used to drive buzzer alarm during mains power failure, is mounted
inside the blood monitor. The battery is connected after installation.
A lithium battery, mounted on the main board, is used to run the real time clock in BM
202.

WARNING!
Lithium battery - danger of explosion! When replacing the battery, use the same type
(recommended by Gambro service representative).

6.3.3.3 Blood Pump Unit


The BM 202 includes two blood pump units (arterial and venous blood pumps). The
blood pump unit consists of the following:
Roller pumps (self-threading).
24 V brush less DC motor with an encoder for velocity monitoring.
Gear box (1:50).
Cover detector.
Blood pump rotation detector.

6.3.3.4 BVS - Blood Volume Sensor


The BVS on the front panel is a passive measurement device. It continuously
measures the hemoglobin concentration of blood in the extracorporeal circuit and
calculates the relative change in the patients blood volume during a dialysis session.
The BVS includes a sensor with optical components for transmitting light through the
cuvette in the blood line. The BVS board has analog transmit- and receiveelectronics
for the optical components and digital electronics for data acquisition, calculations and
communication with the main system. The BVS board is connected direct to the Panel
board, P2.

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6.3.3.5 Drip Chamber Level Adjustment
6 Technical description

Two different drip chamber levels can be adjusted. The level in the venous drip
chamber is electrical adjusted by pressing the level adjustment buttons on the front
panel.
The level in the venous drip chamber is adjusted by pressing or in the right (blue)
area.
The level in the expansion chamber connected to the system pressure transducer
connector may be adjusted by pressing or in the left (gray) area.

6.3.3.6 Fan
The drive motor (24 V DC-motor) and the fan form a single unit.

6.3.3.7 Heparin Pump Unit


The heparin pump unit consists of the following components:
Syringe holder.
Stepping motor.
Gear box (1:120).
Heparin pump position board.
Heparin pump position potentiometer.
Load-limiting device.

6.3.3.8 Line Clamp Unit


The blood monitor includes two line clamps, arterial line clamp and venous line clamp.
The arterial line clamp is located to the right and the venous line clamp is located to
the left when viewed from the front. The clamp covers also have different colour
markings: the arterial clamp cover is marked with a red dot and the venous clamp
cover is marked with a blue dot.
The line clamp unit consists of the following:
Housing with covers (mounted on the front).
Two solenoids (as one unit).
Line clamp driver board (clamp driver circuit on BM CPU board).
Two clamp position detectors (on the clamp driver board).

6.3.3.9 Operator's Panel


The operators panel user interface in AK 200 ULTRA S dialysis machine consists of
45 buttons, 62 LED assemblies and flow indicators, 2 rotary encoders, 8 bar graphs
and a 3 x 7 segment LED display.

6.3.3.10 Pressure Transducers


There are three different Pressure Transducers:
Venous Pressure Transducer
System Pressure Transducer
Arterial Pressure Transducer
BM 202 is equipped with a pressure transducer, Venous Pressure Transducer, which is
used to measure the venous blood pressure. This is located on a transducer board,
which interfaces directly to BM Analog Distribution board, via a board connector. The
pressure transducer is connected to the venous pressure transducer nipple (located on

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146 Technical description
the front panel to the right of the air detector), via a tube and to the level adjustment

6 Technical description
device.
The BM 202 is equipped with a second pressure transducer after the filter, named
System Pressure Transducer. This pressure will only be displayed if the SN data
button is depressed. The transducer is mounted on a transducer board, which also
interfaces directly to the BM Analog Distribution board, via a board connector.
The BM 202 is equipped with a third pressure transducer, named Arterial Pressure
Transducer. This pressure will be displayed on the arterial bargraph. The transducer is
used for true arterial pressure measurement or any other pressure. The pressure
transducer is mounted on a pressure transducer board, which interfaces to the BM
Analog Distribution board, via a board connector.

6.3.3.11 Priming Detector


The priming detector is integrated in the Line Clamp Unit. It has a detector board (on
the back of the front). The detector board contains an LED and a photo transistor. The
current through the LED is indicating how much current that is needed to get a certain
light transmission through the light guides to the receiver. The lower the value is the
better.

6.3.3.12 BPM - Blood Pressure Monitor


The BPM (Blood pressure monitor) is physically placed on the back of the
AK 200 ULTRA S dialysis machine, behind the FM board. The BPM monitor is a
passive measuring device that can issue attentions and alarms but the alarms will not
interfere with the AK 200 ULTRA S dialysis treatment.
The intended use for the BPM is to measure the patients blood pressure and to
activate an alarm if the patients blood pressure goes under an alarm limit set by the
operator. This will give the nurses the possibility to take measures before the patient
suffers the ill effects of hypotension (low blood pressure).
The BPM module includes the following components; air pump, bleed valve, dump
valve, two pressure transducers (control and protective) and microprocessor board.
The module includes control and protective systems.
The control system measures the pressure and pulse wave to calculate the systolic,
diastolic, mean blood pressure and pulse rate. The air pump, dump and bleed valves
are controlled by this system as well as external communication.
The protective system supervises the maximum pressure and inflating time by using
an separate pressure transducer. Maximum pressure is 320 10 mmHg and maximum
inflating time is 180 seconds. When these values exceed specified limits, dump and
bleed valves are opened and air pump is stopped by the protective system.
A self-calibration/auto zero function is included in the module, which means that the
offset for the pressure transducers is calibrated/adjusted each time the module is
turned on.
The BPM measures and calculates the non-invasive blood pressure by using the
oscillometric method. This method uses the pulsation that occurs in the artery in the
arm when it is restricted by the inflated cuff. The noise or oscillation originates from the
fact that when the cuff restricts the vessel, the flow in the vessel becomes turbulent,
instead of laminar. The pulsation causes the pressure in the cuff to oscillate which the
pressure transducer in the BPM module measures.
The relationship between the changes of cuff pressure and its oscillation is used to
determine the blood pressure. When the BPM deflates the cuff and the blood starts to
pass the restriction, the oscillation incline rapidly and the systolic (high) pressure is
measured. When the oscillation has peaked and is declining rapidly the diastolic (low)

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Technical description 147
pressure is measured. The mean pressure is measured when the oscillation is
6 Technical description

peaking. The heart rate is determined by using the pressure oscillations measured by
the pressure transducer.
When to measure the diastolic pressure is determined by extensive experiments to
establish an algorithm, which is included in the BPM software.
In the field it is possible to perform a check of the device to determine if it works or not.
The device has to be sent to Gambro for repair incase of malfunction.

6.3.4 Electrical circuit boards used in the blood monitor

6.3.4.1 Wiring
For a detailed description how to connect all cables in AK 200 ULTRA S dialysis
machine, see the attached drawing:
Wiring Diagram FM 200 S, K20583
Wiring Diagram BM 200 S, K20595
Following is a brief functional description of each board in the blood monitor.

6.3.4.2 BM Analog Distribution Board


This board is localized in the AK 200 ULTRA S blood monitor, where its functions is to
gather all the sensor and motor signals to one cable that is connected to the main BM
CPU board. The devices that are connected on this board are:
Arterial and Venous blood pump cover and position detectors
Heparin position, potentiometer and motor
Priming and tube detector
Level detector transmitter
Arterial, venous and system pressure
Motor A for pressure test
One auxiliary contact

6.3.4.3 Jumpers on the BM Analog Distribution board


J4 Termination of EPRP an EPRN when system
pressure is not mounted
J5 Termination of EPRP an EPRN when system
pressure is not mounted
J6 Termination of BPVC/ in case of single pump

6.3.4.4 Panel Control Board


The operators panel user interface in AK 200 ULTRA S dialysis machine consists of
45 buttons, 62 LED assemblies and flow indicators, 3 rotary encoders (whereof 2 is
used), 8 bar graphs and a 3 x 7 segment LED display. The handling was previously
placed in AK 200 ULTRA S dialysis machine on the BM CPU board. To free up more
physical space and to minimize the cables between the BM CPU board and the panel,
this functionality is moved to a PCB placed directly beneath the operators panel. The
PCB is called the Panel control board.

6.3.4.5 Jumpers on the Panel Control Board


J1, Echelon bus termination

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148 Technical description
1-2 Termination of CEDA-B bus

6 Technical description
open No termination

J2, Service control


1-2 Service pin for micro controller (Service
message will be sent from the micro controller
on the echelon bus)
open Normal

J3, Reset
1-2 Reset
open Normal, reset only possible with IC2 or through
command on the echelon bus

6.3.4.6 BM CPU Board


The BM CPU board controls the blood parts of AK 200 ULTRA S dialysis machine and
can easily be pulled upwards and fixed in the service position.
The board consists of two major parts, control system and protective system.
The board handles I/O such as heparin pump, blood pumps, priming and level
detector, clamps and fan. The BM CPU board is connected through communication
with the FM CPU board and Panel control board.
The LCD display is connected to the BM CPU board. Pressures are measured from
external sensors.

6.3.4.7 Jumpers on the BM CPU board


J2 When closed the protective system is forced
into boot mode
J3 When closed protective system communication
node will reset
J4 When closed protective system communication
node will be forced into service state
J5 Not used. Connected to protective FPGA
J6 To select RS 232 port on FM Power
Distribution Board
J7 When closed the control system is forced into
boot mode.
J8 When closed control system communication
node will reset
J9 When closed control system communication
node will be forced into service state
J10 When closed the blood pump voltage (R24V)
and the pressure test voltage (PT24V) will be
on disregarding status of protective system
and the safe bus
J11 When closed the battery connected to P51 is
charged

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6.3.4.8 Connectors on the BM CPU Board
6 Technical description

Figure 6-6. Inputs and outputs


Connector Name Description
P51 Battery 9 V battery back-up for power
control logic
P55 Test Prot. Comm. Test connector for protective
communication
P56 Tacho BPA Tacho input for arterial blood
pump
P57 Motor BPA Motor output for arterial blood
pump
P58 Test Prot. FPGA Test connector from protective
FPGA
P59 Expansion Prot. sys Expansion from protective
communication
P60 Operator's panel Connector to operator's panel
P61 Level detector Input from level detector
interface
P62 BM I/O Connector to BM I/O interface
P63 24 V Z24P/Z0VP voltage supply
P64 Test Contr. FPGA Test connector from control
FPGA
P65 Level control Output for level adjustment
pump
P66 Fan Output to the fan
P67 Clamp Connector to clamp interface
P68 Tacho BPV Tacho input for venous blood
pump

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Connector Name Description

6 Technical description
P69 Motor BPV Motor output for venous blood
pump
P70 Test Contr. Comm. Test connector for control
communication
P71 24 V Supply Input for 24 V DC supply
voltage
P72 FM Power dist. Input and outputs towards
power distribution board
P73 Back light Supply voltage for back light
inverter on display
P74 Level adjustment Input for level adjustment keys
P75 LVDS LVDS output interface for
display
P76 Parallel interface Parallel interface from
protective FPGA

6.4 Power Supply

Figure 6-7. Power supply


1. DC to the Power distribution board, P65

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Technical description 151
2. AC to the heating rods
6 Technical description

3. Mains cable connector


4. Safety latch for the mains cable
Mains Voltage 115 or 230 V AC (10%)
Frequency 50 or 60 Hz (5 Hz)
Power Consumption Max. 2250 W at 230 V
Max. 1650 W at 115 V
Cable: 3 conductor cable, Length max. 3 m rating 250
V 10 A
Connector: Certified to IEC 320/C13.
Mains plug: 250 V AC / 10 -16 A, approved or Hospital
grade, with protective earth, 125 V AC / 15 A,
approved.
Earth Leakage Current max 500 A
Patient Leakage Current max 100 A
Fuses 2 x T 10 A

All leakage currents are specified without external equipment connected to the
machine.
Mains voltage is fed to an AC/DC converter. The AC/DC converter supplies the DC/DC
units in the fluid monitor and in the blood monitor respectively with supply voltage (+24
V).
A mains transformer and a stabilizer provide the power control logic in the blood
monitor with necessary supply voltage (+12 V).
The power supply also supplies the heater rods in the fluid monitor with their supply
voltage (mains). If the power supply is of 115 V type, the heater rods must be supplied
from the mains directly. Consequently, in this case two mains cables are required: one
is connected between the power unit and the power supply and one is connected
between the power unit and the fluid monitor.
In a mains power failure situation, the AK 200 S / AK 200 ULTRA S dialysis machine
gives an intermittent buzzer alarm and is disconnected from the +24 V supply by
means of signal REMO. Signal REMO is obtained from the power control logic in the
blood monitor.

6.5 Monitor stand


The height of the monitor stand can be adjusted either electrically (MS 202) or in five
fixed positions (MS 200).

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6 Technical description
Figure 6-8. MS 202 electrically adjustable / MS 200 Five fixed positions
1. Infusion pole
The maximum allowed load is 10 kg.
2. Height adjustment for infusion pole
3. Rear handle
4. Bars, lifting positions
Positions where the AK 200 S / AK 200 ULTRA S dialysis machine is safely lifted,
both on the right and left hand side of the machine.
5. Screws
For locking the handle (service frame).
6. Control for height adjustment
For MS 202 only
7. Power supply cord
For MS 202 only
8. Tray for concentrate containers
9. Lockable wheels
The wheels must be locked during treatment. During internal transportation the
AK 200 S / AK 200 ULTRA S dialysis machine must be in upright position.
10. Screws (rear side)
For MS 200 only.

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7 Technical data and specifications - AK 200 S dialysis
machine
7.1 Performance and specification - Control System ................................................. 155
7.1.1 Notes ..................................................................................................................... 155
7.1.2 Blood Flow Control ................................................................................................ 155
7.1.3 Air Detection .......................................................................................................... 155
7.1.4 Heparin Administration .......................................................................................... 156
7.1.5 Blood Volume Sensor (BVS) ................................................................................. 156
7.1.6 Blood Pressure Monitor (BPM).............................................................................. 156
7.1.7 Dialysis fluid preparation ....................................................................................... 156
7.1.8 Dialysis fluid preparation (BiCart Select concentrate system mode
only)................................................................................................................... 157
7.1.9 Ultrafiltration control............................................................................................... 157
7.1.10 Profiling.................................................................................................................. 158
7.1.11 Diascan ................................................................................................................ 158
7.1.12 Disinfection and Cleaning...................................................................................... 159
7.1.13 Water supply.......................................................................................................... 162
7.1.14 Drain ...................................................................................................................... 162
7.1.15 Power supply ......................................................................................................... 162
7.1.16 Connection of external equipment......................................................................... 163
7.1.17 Battery Back-up ..................................................................................................... 164

7.2 Performance and specification - Supervisory system .......................................... 164


7.2.1 Valid accuracy range ............................................................................................. 164
7.2.2 Blood Pressure Supervision .................................................................................. 164
7.2.3 Air Detection .......................................................................................................... 165
7.2.4 Heparin Administration .......................................................................................... 165
7.2.5 Dialysis fluid preparation ....................................................................................... 165
7.2.6 Dialysis fluid preparation (BiCart Select concentrate system mode
only)................................................................................................................... 166
7.2.7 Ultrafiltration .......................................................................................................... 166
7.2.8 Blood leak detection .............................................................................................. 166
7.2.9 Blood loss due to coagulation................................................................................ 166

7.3 Physical data.............................................................................................................. 166

7.4 Materials in contact with water, concentrates and dialysis fluid ......................... 167
7.4.1 Polymers................................................................................................................ 167
7.4.2 Metals .................................................................................................................... 167
7.4.3 Others.................................................................................................................... 167

7.5 Environmental data ................................................................................................... 168


7.5.1 Operation............................................................................................................... 168
7.5.2 Transportation and storage ................................................................................... 168
7.5.3 Energy ................................................................................................................... 168
7.5.4 Electromagnetic environment ................................................................................ 168

7.6 Standards ................................................................................................................... 171

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154 Technical data and specifications - AK 200 S dialysis
machine
7.1 Performance and specification - Control System

7.1.1 Notes
NOTE!

7 Technical data and specifications -


When accuracy ranges are written as e.g. (1ml/min or 1 %) the widest
range is valid.

AK 200 S dialysis machine


For the qualified technician, the Service Manual for the AK 200 S dialysis
machine is available. The Service Manual provides all the necessary information
for the safe and required maintenance of the machine.

7.1.2 Blood Flow Control


Values for the blood pump(s) are based on the arterial blood pump with a pump
segment of 7.9 mm and 2.0 mm wall thickness. For paediatric blood tubes with pump
segment of 4.0 mm it is also possible to set blood flow to 10 or 15 ml/min. Accuracy is
then 5 ml/min.

Table 7-1. Double Needle


Blood Flows in HD, single pump 20 to 500ml/min (10ml/min or 15 %)
Accumulated blood volume 0 to 327litres (0.6l*treatment time(h) or
15 %)

Table 7-2. Single Needle Single Pump


Arterial flow 20 to 500ml/min (10ml/min or 18 %)
Time control 2 to 20sec (1 sec), Arterial and venous time.
The actual clamp opening time is depending
on blood flow rate, size of expansion chamber
and pressure limits.
Pressure control 10 to 600mmHg (50 mmHg), venous
pressure control
Accumulated blood volume 0 to 327litres (0.6l*treatment time(h) or
18 %)

Table 7-3. Single Needle Double Pump (HD only)


Double pump-A 20 to800ml/min
Double pump-V 20 to800ml/min
Mean Flow-SN/DP 10 to400ml/min (10mlor 15 %)
Accumulated blood volume 0 to 99.9litres (0.6l*treatment time(h) or
15 %)
Stroke Volume-SN/DP 2 to 60ml/stroke (15 %) at a cycle time<20s

7.1.3 Air Detection


Sensitivity Bubbles larger than 1l will be trapped by the
drip chamber. An alarm will be issued if the
blood level falls below the middle of the air
detector.
Venous drip chamber size (diameter) 22mm

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Technical data and specifications - AK 200 S dialysis 155
machine
7.1.4 Heparin Administration
Heparinization 0/0.5 to 10 ml/h (1 ml or 0.2 ml *
heparinization time (h) or 5 %)
Stop time, can be preset (Default) 0 to 4.00 h.min (1 min)(20 min)
7 Technical data and specifications -

Syringe size, can be preset(Default) 10 to 30 ml(30 ml)


Maximum counter pressure +650 mmHg
AK 200 S dialysis machine

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

7.1.5 Blood Volume Sensor (BVS)


Relative blood volume -40 % to +10 % from reference value
BV (Standard deviation 3 %) Sensor active for
Hb 80 g/l and blood flow 180 ml/min

7.1.6 Blood Pressure Monitor (BPM)


The alarm limits below can be preset. The value put in brackets and in italics is the
default value.
Systolic pressure rangea,b 40 - 260 mmHg
Low alarm limit, can be preset (Default) 60 - 250 mmHg (100 mmHg)
High alarm limit, can be preset (Default) 60 - 250 mmHg (180 mmHg)
Diastolic pressure rangea,b 20 - 200 mmHg
Low alarm limit, can be preset (Default) 40 - 200 mmHg (40 mmHg)
High alarm limit, can be preset (Default) 40 - 200 mmHg (110 mmHg)
Mean pressure rangea,b 26 - 220 mmHg
Low alarm limit, can be preset (Default) 45 - 235 mmHg (45 mmHg)
High alarm limit, can be preset (Default) 45 - 235 mmHg (235 mmHg)
Rated cuff pressure rangeb 120 - 280 mmHg
Pulse rate rangeb 30 - 220 bpm (2 bpm or 2 % of reading)
Low alarm limit, can be preset (Default) 40 - 180 bpm (40 bpm)
High alarm limit, can be preset (Default) 40 - 180 bpm (130 bpm)
aMeets ANSI/AAMI SP-10 (1992). Mean error 5 mmHg. Standard deviation 8 mmHg
bThe rated range is valid for the blood pressure monitor Suntech firmware version 3.41 or higher.

7.1.7 Dialysis fluid preparation


Table 7-4. Temperature
Dialysis Fluid Temperature 33-40 C (+0.5/-1.5 C)
(+0.5/-2.7 C) with UFD-kit at fluid flow <500
ml/min.
Temperature low alarm, can be preset 31 to 41 C (35)
(Default)
Temperature high alarm, can be preset 31 to 41 C (39)
(Default)

Table 7-5. Fluid flow


Dialysis Fluid Flow Rate 300 to 700 ml/min (10 ml/min)

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156 Technical data and specifications - AK 200 S dialysis
machine
Table 7-6. Conductivity
Conductivity measuring 0.1 - 20 mS/cm (0.1 mS/cm)
Alarm limits in Acetate mode 5 % of set value
Alarm limit in Bicarbonate mode, A-step 5 % of set value for A-step conductivity

7 Technical data and specifications -


(acidic)
Alarm Limit in Bicarbonate mode, B-step 5 % of set value for B-step conductivity
(bicarbonate)

AK 200 S dialysis machine


Alarm limits are extended to 10 % for maximum 2 minutes of 10 minutes.

Table 7-7. Concentration


Na+, Acetate mode 115 to 160 mmol/l (4 mmol/l)
Na+, Bicarbonate mode 130 to 150 mmol/l (6 mmol/l)
HCO3-, Bicarbonate mode 20 to 40 mmol/l (6 mmol/l)

Table 7-8. Concentrates


Max. pressure for concentrates +50 kPa

Table 7-9. pH supervision


pH measurement of Dialysis Fluid 1 to 9.9 pH units (0.2 pH units for pH 5 to 9,
0.5 pH units for pH<5 or pH>9)
pH low alarm, can be preset (Default) 1 to 15 pH units (6 Acetate mode, 6.5 Bicarb
mode)
pH high alarm, can be preset (Default) 1 to 15 pH units (8 Acetate mode, 7.8 Bicarb
mode)

Table 7-10. Degassing


Degassing pressure in Acetate mode, can be -700 to -500 mmHg (30 mmHg) (-630 mmHg)
preset (Default) Minimum 75 mmHg absolute pressure
Degassing pressure in Bicarbonate mode, can -700 to -500 mmHg (30 mmHg) (-580 mmHg)
be preset (Default) Minimum 75 mmHg absolute pressure

7.1.8 Dialysis fluid preparation (BiCart Select concentrate system mode


only)
Table 7-11. Fluid flow
1 L SelectBag concentrate Proportioning 1:200 (3 %)
Ratio 1 L SelectBag concentrate Proportioning Ratio
is defined as the quotient 1 L SelectBag
concentrate flow/dialysis fluid flow

7.1.9 Ultrafiltration control


Table 7-12. Volume control
UF volume max. 30 litres (50 ml or 50 ml * passed
treatment time (h) or 2.5 %)
UF-rate 0.0 to 4.0 l/h
Treatment Time 0.05 to 9.59 hour.minute (1 minute)

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Technical data and specifications - AK 200 S dialysis 157
machine
7.1.10 Profiling
UF-rate 0 to 4 l/h
Na+, Acetate mode 115 to 160 mmol/l
Na+, Bicarbonate mode 130 to 150 mmol/l
7 Technical data and specifications -

HCO3-, Bicarbonate mode 20 to 40 mmol/l


AK 200 S dialysis machine

Table 7-13. Half-times


Degressive Set in h.min, 10 to 25 % of remaining
treatment time
Progressive Set in h.min, 75 to 90 % of remaining
treatment time

7.1.11 Diascan
Accuracy is valid in HD mode double needle treatment, for blood flows 200 to 500
ml/min and fluid flows 500 to 700 ml/min, UF profiling is allowed.
Clearance, K 0 to 350 ml/min (10 %)
Cumulated water volume cleared of urea, Kt 0 to 100 l (10 %)
Dialysis dose, Kt/V 0 to 3 (10 %)
Plasma sodium, Na+ 130 to 160 mmol/l

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158 Technical data and specifications - AK 200 S dialysis
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7.1.12 Disinfection and Cleaning
Temperature and time in different phases and concentration of disinfectant are
possible to preset. The values in this specification are the default values and what the
machine has been validated against. Follow the instructions from the manufacturer of
the disinfectant, to set the correct dilution and dwell time. All disinfection programs in

7 Technical data and specifications -


the AK 200 S dialysis machine are tested in accordance with the French standard NFS
90-304 and established to fulfil the requirements expressed in the same standard.
Time for disinfection programs is estimated and may vary.

AK 200 S dialysis machine


All values below are applicable for the 230V AC variant. For the 115V AC variant add 5
minutes to all heating programs. For the 115V AC S UFD variant add 7 minutes to all
heating programs.

Table 7-14. Heat disinfection Program


Temperature 93 C
Fill up phase 10 minutes
(13 minutes with UFD-kit (optional))
Circulation phase 15 minutes
Drain phase 4 minutes
Total time 29 minutes
(32 minutes with UFD-kit, (optional))

Table 7-15. Heat disinfection Program with CleanCart cartridge


Decalcification CleanCart C
Cleaning CleanCart A
Temperature 93 C
Fill up and mixing phase 12 minutes
(13 minutes with UFD-kit (optional))
Circulation phase 15 minutes
Rinse/Drain phase 5 minutes
(11 minutes with UFD-kit (optional))
Total time 32 minutes
(39 minutes with UFD-kit (optional))

Table 7-16. Heat disinfection Program with liquid citric acid


Temperature 93 C
Concentration 20 % citric acid
Concentration in machine 2 % citric acid; i.e. diluted 1 + 9
Consumption Approx. 200 ml
(Approx. 230 ml with UFD-kit (optional))
Fill up and mixing phase 15 minutes
(18 minutes with UFD-kit (optional))
Circulation phase 15 minutes
Rinse/Drain phase 10 minutes
Total time 40 minutes
(43 minutes with UFD-kit (optional))

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Technical data and specifications - AK 200 S dialysis 159
machine
Table 7-17. Heat disinfection Program with WRO 300 H
Temperature 93 C
Fill up phase 10 minutes
(13 minutes with UFD-kit (optional))
7 Technical data and specifications -

Circulation phase 15 minutes


Low flow heat phase 20 minutes
AK 200 S dialysis machine

Drain phase 4 minutes


Total time 49 minutes
(52 minutes with UFD-kit (optional))

Table 7-18. Heat disinfection Program with CleanCart cartridge including WRO 300 H
Decalcification CleanCart C
Cleaning CleanCart A
Temperature 93 C
Fill up phase 10 minutes
(13 minutes with UFD-kit (optional))
Circulation phase 15 minutes
Low flow heat phase 20 minutes
Rinse/Drain phase 4 minutes
(11 minutes with UFD-kit (optional))
Total time 49 minutes
(59 minutes with UFD-kit (optional))

Table 7-19. Peracetic Acid Program


Concentration of disinfectant 3.5 % peracetic acid
Concentration in machine 0.1 % ; i.e. diluted 1 + 34
Consumption Approx. 65 ml
(Approx. 75 ml with UFD-kit (optional))
Fill up and mixing phase 12 minutes
(17 minutes with UFD-kit (optional))
Dwell time 10 minutes
Rinse/Drain phase 23 minutes
(43 minutes with UFD-kit (optional))
Total time 45 minutes including 10 min dwell time
(70 minutes including 10 min dwell time with
UFD-kit (optional))

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160 Technical data and specifications - AK 200 S dialysis
machine
Table 7-20. Low concentration Peracetic Acid Program
Concentration of disinfectant 0.35 % peracetic acid
(0.35 % peracetic acid with UFD-kit (optional))
Concentration in machine 0.01 % ; i.e. diluted 1 + 34

7 Technical data and specifications -


(0.01 % ; i.e. diluted 1 + 34 with UFD-kit
(optional))
Consumption Approx. 65 ml

AK 200 S dialysis machine


(Approx. 75 ml with UFD-kit (optional))
Fill up and mixing phase 12 minutes
(17 minutes with UFD-kit (optional))
Dwell time 10 minutes
Rinse/Drain phase 16 minutes
(28 minutes with UFD-kit (optional))
Total time 38 minutes including 10 min dwell time
(55 minutes including 10 min dwell time with
UFD-kit (optional))

Table 7-21. Hypochlorite Program


Concentration of disinfectant 0.5 % available chlorine (approximately 70 %
of sodium hypochlorite concentration)
Concentration in machine 0.5 % ; i.e. not diluted
Consumption Approx. 2000 ml
(Approx. 2500 ml with UFD-kit (optional))
Fill up and mixing phase 12 minutes
(25 minutes with UFD-kit (optional))
Dwell time 10 minutes, Maximum 20 min
Rinse/Drain phase 23 minutes
(39 minutes with UFD-kit (optional))
Total time 45 minutes including 10 min dwell time
(74 minutes including 10 min dwell time with
UFD-kit (optional))

Table 7-22. Central Chemical Disinfection Program


Concentration of disinfectant 0.1 % peracetic acid or 0.5 % available
chlorine
Concentration in machine Not diluted
Consumption Approx. 3100 ml
(Approx. 3600 ml with UFD-kit (optional))
Dwell time Must be preset, maximum 20 min. for
hypochlorite
Total time 32 minutes (dwell time not included)
(64 minutes (dwell time not included) with
UFD-kit (optional))

Table 7-23. Other programs, total time


Rinse/Drain 12 min
(13 min with UFD-kit (optional))
Drain 4 min

External Cleaning 70 % Ethanol or 60 % Isopropanol

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Technical data and specifications - AK 200 S dialysis 161
machine
7.1.13 Water supply
Table 7-24. Water Supply Flow Rate
Treatment 300 to 750 ml/min
Disinfection 0 to 1150 ml/min
7 Technical data and specifications -

Table 7-25. Inlet Water Pressure


AK 200 S dialysis machine

To regulator 120 to 800 kPa


To machine 85 to 120 kPa

Table 7-26. Inlet Water Temperature


Treatment +5 to +30 C
Disinfection +5 to +90 C

Table 7-27. Inlet Water Quality


Inlet water quality must comply with local regulations and if no such regulation is available
follow ISO 13959. Level for conductivity shall not exceed 0.1 mS/cm. It is possible to use water
with higher conductivity if it consists mainly of sodium salts. This may however affect the
accuracy of the fluid composition.

Table 7-28. Inlet tube length


Maximum 5 m or the specially designed spiral PEX tubing

7.1.14 Drain
Drain (length of tube) Maximum 5 m
Drain capacity Minimum 1.0 l/min
Drain outlet Maximum 1.2 m above floor

If the optional air-gap on the machine is used the distance between the air-gap and the
drain must not be less than 0.3 m. For an electrically adjustable stand in its lowest
position this means that the drain must not be higher than 580 mm. For a mechanically
adjustable stand in its lowest position the drain must not be higher than 550 mm.

7.1.15 Power supply


Mains Voltage 115 or 230 V AC (10 %)
Frequency 50 or 60 Hz (5 Hz)
Power Consumption Max. 2250 W at 230 V
Max. 1650 W at 115 V
Mains cable 3 conductor cable, Length max. 3 m rating 250
V 10 A, 13 -16A
Mains cable connector Certified to IEC 60320/C19
Mains cable plug Plug with protective earth, 250 V AC / 13 -16
A, or Hospital grade plug with protective earth,
125 V AC / 15 A.
Earth Leakage Current max 500 A
Patient Leakage Current max 100 A
Fuses 2 x T 10 A

All leakage currents are specified without external equipment connected to the
machine.

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162 Technical data and specifications - AK 200 S dialysis
machine
7.1.16 Connection of external equipment
Additional equipment connected to medical electrical equipment must comply with the
respective IEC or ISO standards (e.g. IEC 60950 for data processing equipment).
Furthermore all configurations shall comply with the requirements for medical electrical
systems (see IEC 6060111 or clause 16 of the 3Ed. of IEC 606011, respectively).

7 Technical data and specifications -


Anybody connecting additional equipment to medical electrical equipment configures a
medical system and is therefore responsible that the system complies with the
requirements for medical electrical systems. Attention is drawn to the fact that local

AK 200 S dialysis machine


laws take priority over the above mentioned requirements. If in doubt, consult your
local representative or the technical service department. Use of other cables may
result in increased emissions or decreased immunity for the equipment or system.
Protective caps shall be attached when the connectors are not in use.

Table 7-29. External serial interface


External connector P 63 8 pin REDEL contact, black. RS-232 or
RS-422 compatible connection. Opto insulated
fulfilling IEC 60601-1-1. Attached cable length
2.5 m unshielded.
External equipment Serial port for connection to PC used for
logging and preset.

Table 7-30. RS-232


Max input voltage 15 V DC
High level min output voltage +5 V DC
Low level max output voltage -5 V DC
Max output current 5 mA

Table 7-31. RS-422


Max input voltage 7 V DC
Diff. input threshold voltage 0.2 V DC
Diff. max. output voltage 5 V DC
Diff. min. output voltage 2 V DC
Short circuit output current 100 mA

Table 7-32. External interface


External connector P 79 8 pin REDEL, yellow, configured as 1 make-
and 2 change over- relay contacts. Attached
cable length 2.9 m unshielded.
External equipment Port for connection to central alarm system
and remote control of water system.

Table 7-33. Contact ratings


Max voltage 24 V AC or DC
Max current 100 mA AC or DC

Table 7-34. External I/O interface


External connector P 76 8 pin REDEL blue. Opto insulated fulfilling IEC
60601-1-1. Attached cable length 1.5 m
unshielded.
External equipment Connection to Gambro UF Calibration Unit.
Service purpose only.

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Technical data and specifications - AK 200 S dialysis 163
machine
Table 7-35. External interface
External connector P 64 8 pin RJ-45
External equipment Ethernet port for connection to network only
intended for Exalis computer system,
7 Technical data and specifications -

download, preset and logging


AK 200 S dialysis machine

7.1.17 Battery Back-up


Battery back-up of power supply 24 volt, 6.5 Ah
Running time >15 minutes
Fuse T 15 A

7.2 Performance and specification - Supervisory system

7.2.1 Valid accuracy range


NOTE!
When accuracy ranges are written as e.g. (1 ml/min or 1 %) the widest range is
valid.

7.2.2 Blood Pressure Supervision


The alarm limits below can be preset. The value put in brackets and in italics is the
default value.

Table 7-36. Venous Pressure


Operating range -700 to +750 mmHg
(10 % at -700 to -500 mmHg)
(5 mmHg or 3 % at -500 to +500 mmHg)
(10 % at +500 to +750 mmHg)
Alarm limit HIGH max +600 mmHg (+300 mmHg)
Alarm limit LOW min -50 mmHg (-50 mmHg)
When blood is detected the operator is
requested to centralize the alarm limits and the
low limit is by default set to +10 mmHg

Table 7-37. Arterial Pressure


Operating range -700 to +750 mmHg
(10 % at -700 to -500 mmHg)
(5 mmHg or 3 % at -500 to +500 mmHg)
(10 % at +500 to +750 mmHg)
Alarm limit HIGH max +750 mmHg (+250 mmHg)
Alarm limit LOW min -700 mmHg (-250 mmHg)

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164 Technical data and specifications - AK 200 S dialysis
machine
Table 7-38. System Pressure
Operating range -700 to +750 mmHg
(10 % at -700 to -500 mmHg)
(5 mmHg or 3 % at -500 to +500 mmHg)

7 Technical data and specifications -


(10 % at +500 to +750 mmHg)
Alarm limit SN/DP HIGH max +300 mmHg (+175 mmHg)

AK 200 S dialysis machine


Alarm limit SN/DP LOW min -200 mmHg (+10 mmHg)
Alarm limit SP HIGH max +750 mmHg (+150 mmHg)
Alarm limit SP LOW min -

7.2.3 Air Detection


Sensitivity Bubbles larger than 1 l will be trapped by the
drip chamber. An alarm will be issued if the
blood level falls below the middle of the air
detector.
Venous drip chamber size (diameter) 22 mm

7.2.4 Heparin Administration


Heparinization volume alarm limit 0.3 ml of set value (1 ml or 0.2 ml *
heparinization time (h) or 5 %)

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

7.2.5 Dialysis fluid preparation


Table 7-39. Temperature
Low temperature alarm limit 32.5 C (+0.5/-2.0 C)
High temperature alarm limit 41.5 C (+0.5/-2.5 C)
(+0.5/-2.7 C) with UFD-kit at fluid flow < 500
ml/min

Table 7-40. Conductivity


Alarm limits in Acetate mode 5 % of set value
Alarm Limit in Bicarbonate mode, A-step 5 % of set value for A-step conductivity
(acidic)
Alarm Limit in Bicarbonate mode, B-step 5 % of set value for B-step conductivity
(bicarbonate)

Alarm limits are temporarily extended to 10 %. Maximum mean deviation for a 5 hour
treatment is 0.2 mS/cm.

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Technical data and specifications - AK 200 S dialysis 165
machine
7.2.6 Dialysis fluid preparation (BiCart Select concentrate system mode
only)
Dialysis Fluid Flow Rate 300 - 700 ml/min (9 ml/min)
Dialysis Fluid Flow Rate alarm limit 5 %
7 Technical data and specifications -

1 L SelectBag concentrate Proportioning Ratio 1:200 12 %, alarm given within 20 minutes.


alarm limit For larger errors the alarm time is shorter.
1 L SelectBag concentrate Proportioning Ratio
AK 200 S dialysis machine

is defined as the quotient 1 L SelectBag


concentrate flow/dialysis fluid flow

7.2.7 Ultrafiltration
Dialysis fluid flow operating range 300 - 700 ml/min
UF rate supervision -4.0 to +4.0 l/h (2 ml/min). Accuracy 5
ml/min verified at start-up.
UF rate supervision, max allowed difference 1-10 ml/min, ( 5 ml/min)
between control and protective system, can be
preset (Default)
Accumulated UF volume alarm limit (Default) 200 ml, or 70 - 130 ml/h ( 130 ml/h) *
passed treatment time (h), whichever is
greatest.
Treatment Time Control 0.05 to 9.59 hour.minute (1 minute)
TMP supervision alarm -200 to +550 mmHg (15 mmHg) For
AK 200 S dialysis machine, TMP is defined as
Pb out -Pd out + Offset, where Pb out is the
venous drip chamber pressure and Pd out is
the pressure measured in the dialysis fluid,
where it enters the machine after the dialyzer.
The offset compensates for the vertical
distance between the pressure sensors.

7.2.8 Blood leak detection


Sensitivity 0.15 ml blood/min at 300 ml/min dialysis fluid
flow rate
0.35 ml blood/min at 700 ml/min dialysis fluid
flow rate
haematocrit 32 % 2 %
Alarm response time (diffusion mode) 7 seconds

7.2.9 Blood loss due to coagulation


Supervision of blood pump stop time (Default) 10 to 180 seconds (60 seconds)

7.3 Physical data


Depth Approx. 610 mm
Width Approx. 570 mm
Total Height Adjustable heights 1175 - 1340 mm
Five position stand 1152 - 1382 mm
Floor Area 573 x 753 mm
Weight Blood Monitor Approx. 17 kg

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166 Technical data and specifications - AK 200 S dialysis
machine
Weight Fluid Monitor Approx. 40 kg
Weight Stand Approx. 24 to 31 kg
Total Weight Approx. 81 to 88 kg
Infusion Stand Height 1300 to 2150 mm
Max. load 10 kg

7 Technical data and specifications -


Transportation One man installation
Fitting into a normal Estate car

AK 200 S dialysis machine


References
Assembly Drawing: K22100

7.4 Materials in contact with water, concentrates and dialysis


fluid

7.4.1 Polymers
Silicon rubber
Santroprene
PVC (Polyvinylchloride)
PEEK (Polyetherketone)
PEX (Polyethylene)
PP (Polypropylene)
PP (Polypropylene reinforced with talcum)
PSU (Polysulphone)
PVDF (Polyvinylidene fluoride)
PTFE (Polytetrafluoro ethylene)
Parylene C

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

7.4.3 Others
Carbon
Ceramic, Steatite 221
Ceramic, Aluminum oxide (Al2O3)
Ceramic, Zirconium oxide (ZrO2)
Glass
Barium Ferrite

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Technical data and specifications - AK 200 S dialysis 167
machine
7.5 Environmental data

7.5.1 Operation
If condensation occur when moving the equipment between locations with different
7 Technical data and specifications -

temperatures and high relative humidity (e.g. outdoor and indoor locations), the inside
of the equipment shall be allowed to dry before switching on the equipment.
AK 200 S dialysis machine

Ambient Temperature range +18 to +35 C


Relative Humidity range 15 to 85 % RH
Air Pressure range (atm. pressure) 700 to 1060 hPa
Maximum altitude 2000 m above sea level

7.5.2 Transportation and storage


During transportation and storage the equipment has to be kept in its original packing.
If transportation or storage time is more than 15 weeks, the environmental data
relating to the operation has to be followed. The maximum ambient temperature for
transportation and storage in 96 % Relative humidity is +40 C.
Ambient Temperature range -20 to +70 C
Relative Humidity range 10 to 96 % RH
Air Pressure range (atm. pressure) 500 to 1060 hPa
Maximum altitude 2000 m above sea level

7.5.3 Energy
Typical energy consumption for a 4 hour treatment with inlet water temperature of 5 C
and 500 ml/h main flow is 2.7 kWh. Energy delivery to the environment is
approximately 400 Wh independent of inlet water temperature.
Energy delivery to the drain during a 4 hour treatment is 2.3 kWh.
The temperature at the drain can be up to 80 C.
Power consumption and delivery to the drain decrease with approximately 19 W for
every degree increase of inlet water temperature.

7.5.4 Electromagnetic environment


The AK 200 S dialysis machine is intended for use in the electromagnetic environment
specified below. The customer or the user of the AK 200 S dialysis machine should
assure that it is used in such an environment.

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168 Technical data and specifications - AK 200 S dialysis
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Emissions test Compliance Electromagnetic environment
guidance
RF emissions Group 1 The AK 200 S dialysis machine uses RF
CISPR 11 energy only for its internal function.
Therefore, its RF emissions are very low
and are not likely to cause any

7 Technical data and specifications -


interference in nearby electronic
equipment.

AK 200 S dialysis machine


RF emissions Class B The AK 200 S dialysis machine is suitable
CISPR 11 for use in all establishments, including
domestic establishments and those
directly connected to the public
low-voltage power supply network that
supplies buildings used for domestic
purposes.
Harmonic emissions Class A (Not applicable for 115
IEC 61000-3-2 V version)

Voltage fluctuations /flicker Complies (Not applicable for


emissions 115 V version)
IEC 61000-3-3

Immunity test IEC 60601 Compliance level Electromagnetic


test level environment-guidance
Electrostatic discharge 6 kV contact 6 kV contact Floors should be wood,
(ESD), 8 kV Air 8 kV Air concrete or ceramic tile. If
IEC 61000-4-2 floors are covered with
synthetic material, the
relative humidity should
be at least 30 %.
Electrical fast 2 kV for power lines 2 kV for power lines Mains power quality
transient/burst, 1 kV for input/output 1 kV for input/output should be that of a typical
IEC 61000-4-4 lines lines commercial or hospital
environment.
Surge 1 kV for differential mode 1 kV for differential mode Mains power quality
IEC 61000-4-5 2 kV for common mode 2 kV for common mode should be that of a typical
commercial or hospital
environment.
Voltage dips, short <5 % UT <5 % UT Mains power quality
interruptions and voltage (>95 % dip in UT) (>95 % dip in UT) should be that of a typical
variations on power commercial or hospital
for 0.5 cycle for 0.5 cycle
supply input lines. environment. If the user of
40 % UT 40 % UT the AK 200 S dialysis
IEC 61000-4-11
(60 % dip in UT) (60 % dip in UT) machine requires
for 5 cycles for 5 cycles continued operation
during power mains
70 % UT 70 % UT interruptions, it is
(30 % dip in UT) (30 % dip in UT) recommended that the
for 25 cycles for 25 cycles AK 200 S dialysis machine
be powered from an
<5 % UT <5 % UT
uninterruptible power
(>95 % dip in UT) (>95 % dip in UT) supply or a battery.
for 5 sec for 5 sec
Power frequency (50/60 3 A/m 3 A/m Power frequency
Hz) magnetic field magnetic fields should be
IEC 61000-4-8 at levels characteristic of
a typical location in a
typical commercial or
hospital environment.

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Technical data and specifications - AK 200 S dialysis 169
machine
NOTE!
UT is the a.c. mains voltage prior to application of the test level.
Immunity test IEC 60601 Compliance Electromagnetic enviroment-guidance
test level level
7 Technical data and specifications -

Portable and mobile RF communications


equipment should be used no closer to any part of
the AK 200 S dialysis machine, including cables,
AK 200 S dialysis machine

than the recommended separation distance


calculated from the equation applicable to the
frequency of the transmitter.
Recommended separation distance
Conducted RF 3 Vrms 3V
IEC 61000-4-6 150 kHz to 80
MHz

Radiated RF 3 V/m 3 V/m


IEC 61000-4-3 80 MHz to 2.5
GHz

80 MHz to 800

800 MHz to 2.5 GHz


Radiated RF - 30 V/m where P is the maximum output power rating of the
mobile phones transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended
separation distance in meters (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site surveya,
should be less than the compliance level in each
frequency rangeb.
Interference may occur in the vicinity of equipment
marked with the following symbol:

aField strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile
radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To
assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the AK 200 S dialysis machine is used exceeds the
applicable RF compliance level above, the AK 200 S dialysis machine should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the
AK 200 S dialysis machine.
bOver the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
NOTE!
At 80 MHz and 800 MHz, the higher frequency range applies.
These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.

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170 Technical data and specifications - AK 200 S dialysis
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Recommended separation distances between portable and mobile RF communications equipment
and the AK 200 S dialysis machine
The AK 200 S dialysis machine is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the AK 200 S dialysis machine can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the AK 200 S dialysis machine as recommended below,

7 Technical data and specifications -


according to the maximum output power of the communications equipment.
Rated maximum output Separation distance according to frequency of transmitter

AK 200 S dialysis machine


power of transmitter (m)
W
150kHz - 80MHz 80MHz - 800MHz 800MHz - 2500MHz

0.01 0.11 0.11 0.23


0.1 0.37 0.37 0.74
1 1.2 1.2 2.3
10 3.7 3.7 7.4
100 12 12 23
Rated maximum output - -
power of mobile phone

2W - - 0.33
GSM/3G
For transmitters rated at a maximum output power not listed above, the recommended separation distance d
in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is
the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE!
At 80 MHz and 800 MHz, the separation distance for the higher frequency range
applies.
These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.

7.6 Standards
The machine complies with the following standards:
IEC 60601-1 General requirements for safety, Class I, type B
IEC 60601-2-16 Particular requirements for safety of haemodialysis, haemodiafiltration
and haemofiltration equipment
IEC 60601-2-30 Particular requirements for the safety of automatic cycling indirect
blood pressure monitoring equipment
IEC 60601-1-2 Electromagnetic compatibility
EN 1060-1 Non-invasive sphygmomanometers Part 1: General requirements
EN 1060-3 Non-invasive sphygmomanometers Part 3: Supplementary requirements
for electromechanical blood pressure measuring systems
NFS 90-304 Medico-surgical equipment Hemodialysis equipment

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machine
8 Technical data and specifications - AK 200 ULTRA S
dialysis machine
8.1 Performance and specification - Control System ................................................. 173
8.1.1 Notes ..................................................................................................................... 173
8.1.2 Blood Flow Control ................................................................................................ 173
8.1.3 Air Detection ......................................................................................................... 173
8.1.4 Heparin Administration .......................................................................................... 174
8.1.5 Blood Volume Sensor (BVS) ................................................................................. 174
8.1.6 Blood Pressure Monitor (BPM).............................................................................. 174
8.1.7 Dialysis fluid preparation ....................................................................................... 174
8.1.8 Dialysis fluid preparation (BiCart Select concentrate system mode
only)................................................................................................................... 175
8.1.9 Ultrafiltration control............................................................................................... 176
8.1.10 Substitution fluid .................................................................................................... 176
8.1.11 Profiling.................................................................................................................. 176
8.1.12 Diascan ................................................................................................................ 176
8.1.13 Disinfection and Cleaning...................................................................................... 177
8.1.14 Water supply.......................................................................................................... 179
8.1.15 Drain ...................................................................................................................... 179
8.1.16 Power supply ......................................................................................................... 179
8.1.17 Connection of external equipment......................................................................... 180
8.1.18 Battery Back-up ..................................................................................................... 181

8.2 Performance and specification - Supervisory system .......................................... 181


8.2.1 Valid accuracy range ............................................................................................. 181
8.2.2 Blood Pressure Supervision .................................................................................. 181
8.2.3 Air Detection .......................................................................................................... 182
8.2.4 Heparin Administration .......................................................................................... 182
8.2.5 Dialysis fluid preparation ....................................................................................... 182
8.2.6 Dialysis fluid preparation (BiCart Select concentrate system mode
only)................................................................................................................... 183
8.2.7 Ultrafiltration .......................................................................................................... 183
8.2.8 Blood leak detection .............................................................................................. 183
8.2.9 Blood loss due to coagulation................................................................................ 183

8.3 Physical data.............................................................................................................. 183

8.4 Materials in contact with water, concentrates and dialysis fluid ......................... 184
8.4.1 Polymers................................................................................................................ 184
8.4.2 Metals .................................................................................................................... 184
8.4.3 Others.................................................................................................................... 184

8.5 Environmental data ................................................................................................... 185


8.5.1 Operation............................................................................................................... 185
8.5.2 Transportation and storage ................................................................................... 185
8.5.3 Energy ................................................................................................................... 185
8.5.4 Electromagnetic environment ................................................................................ 185

8.6 Standards ................................................................................................................... 188

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172 Technical data and specifications - AK 200 ULTRA S
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8.1 Performance and specification - Control System

8.1.1 Notes
NOTE!
When accuracy ranges are written as e.g. (1ml/min or 1 %) the widest
range is valid.
For the qualified technician, the Service Manual for the AK 200 ULTRA S
dialysis machine is available. The Service Manual provides all the necessary
information for the safe and required maintenance of the machine.

8.1.2 Blood Flow Control

8 Technical data and specifications -


AK 200 ULTRA S dialysis machine
Values for the blood pump(s) are based on the arterial blood pump with a pump
segment of 7.9 mm and 2.0 mm wall thickness. For paediatric blood tubes with pump
segment of 4.0 mm it is also possible to set blood flow to 10 or 15 ml/min. Accuracy is
then 5 ml/min.

Table 8-1. Double Needle


Blood Flows in HD, single pump 20 to 500ml/min (10ml/min or 15 %)
Blood Flows in HDF, HF 20 to 700ml/min (10ml/min or 15 %)
Accumulated blood volume 0 to 327litres (0.6l*treatment time(h) or
15 %)

Table 8-2. Single Needle Single Pump (HD, HDF only)


Arterial flow 20 to 500ml/min (10ml/min or 18 %)
Time control 2 to 20sec (1 sec), Arterial and venous time.
The actual clamp opening time is depending
on blood flow rate, size of expansion chamber
and pressure limits.
Pressure control 10 to 600mmHg (50 mmHg), venous
pressure control
Accumulated blood volume 0 to 327litres (0.6l*treatment time(h) or
18 %)

Table 8-3. Single Needle Double Pump (HD only)


Double pump-A 20 to800ml/min
Double pump-V 20 to800ml/min
Mean Flow-SN/DP 10 to400ml/min (10mlor 15 %)
Accumulated blood volume 0 to 99.9litres (0.6l*treatment time(h) or
15 %)
Stroke Volume-SN/DP 2 to 60ml/stroke (15 %) at a cycle time<20s

8.1.3 Air Detection


Sensitivity Bubbles larger than 1l will be trapped by the
drip chamber. An alarm will be issued if the
blood level falls below the middle of the air
detector.
Venous drip chamber size (diameter) 22mm

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8.1.4 Heparin Administration
Heparinization 0/0.5 to 10 ml/h (1 ml or 0.2 ml *
heparinization time (h) or 5 %)
Stop time, can be preset (Default) 0 to 4.00 h.min (1 min)(20 min)
Syringe size, can be preset(Default) 10 to 30 ml(30 ml)
Maximum counter pressure +650 mmHg

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

8.1.5 Blood Volume Sensor (BVS)


Relative blood volume -40 % to +10 % from reference value
8 Technical data and specifications -
AK 200 ULTRA S dialysis machine

BV (Standard deviation 3 %) Sensor active for


Hb 80 g/l and blood flow 180 ml/min

8.1.6 Blood Pressure Monitor (BPM)


The alarm limits below can be preset. The value put in brackets and in italics is the
default value.
Systolic pressure rangea,b 40 - 260 mmHg
Low alarm limit, can be preset (Default) 60 - 250 mmHg (100 mmHg)
High alarm limit, can be preset (Default) 60 - 250 mmHg (180 mmHg)
Diastolic pressure rangea,b 20 - 200 mmHg
Low alarm limit, can be preset (Default) 40 - 200 mmHg (40 mmHg)
High alarm limit, can be preset (Default) 40 - 200 mmHg (110 mmHg)
Mean pressure rangea,b 26 - 220 mmHg
Low alarm limit, can be preset (Default) 45 - 235 mmHg (45 mmHg)
High alarm limit, can be preset (Default) 45 - 235 mmHg (235 mmHg)
Rated cuff pressure rangeb 120 - 280 mmHg
Pulse rate rangeb 30 - 220 bpm (2 bpm or 2 % of reading)
Low alarm limit, can be preset (Default) 40 - 180 bpm (40 bpm)
High alarm limit, can be preset (Default) 40 - 180 bpm (130 bpm)
aMeets ANSI/AAMI SP-10 (1992). Mean error 5 mmHg. Standard deviation 8 mmHg
bThe rated range is valid for the blood pressure monitor Suntech firmware version 3.41 or higher.

8.1.7 Dialysis fluid preparation


Table 8-4. Temperature
Dialysis Fluid Temperature 33-40 C (+0.5/-1.5 C)
(+0.5/-2.7 C) at fluid flow <500 ml/min.
Temperature low alarm, can be preset 31 to 41 C (35)
(Default)
Temperature high alarm, can be preset 31 to 41 C (39)
(Default)

Table 8-5. Fluid flow


Dialysis Fluid Flow Rate 300 to 700 ml/min (10 ml/min)

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174 Technical data and specifications - AK 200 ULTRA S
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Table 8-6. Conductivity
Conductivity measuring 0.1 - 20 mS/cm (0.1 mS/cm)
Alarm limits in Acetate mode 5 % of set value
Alarm limit in Bicarbonate mode, A-step 5 % of set value for A-step conductivity
(acidic)
Alarm Limit in Bicarbonate mode, B-step 5 % of set value for B-step conductivity
(bicarbonate)

Alarm limits are extended to 10% for maximum 2 minutes of 10 minutes

Table 8-7. Concentration


Na+, Acetate mode 115 to 160 mmol/l (4 mmol/l)

8 Technical data and specifications -


AK 200 ULTRA S dialysis machine
Na+, Bicarbonate mode 130 to 150 mmol/l (6 mmol/l)
HCO3-, Bicarbonate mode 20 to 40 mmol/l (6 mmol/l)

Table 8-8. Concentrates


Max. pressure for concentrates +50 kPa

Table 8-9. pH supervision


pH measurement of Dialysis Fluid 1 to 9.9 pH units (0.2 pH units for pH 5 to 9,
0.5 pH units for pH<5 or pH>9)
pH low alarm, can be preset (Default) 1 to 15 pH units (6 Acetate mode, 6.5 Bicarb
mode)
pH high alarm, can be preset (Default) 1 to 15 pH units (8 Acetate mode, 7.8 Bicarb
mode)

Table 8-10. Degassing


Degassing pressure in Acetate mode, can be -700 to -500 mmHg (30 mmHg) (-630 mmHg)
preset (Default) Minimum 75 mmHg absolute pressure
Degassing pressure in Bicarbonate mode, can -700 to -500 mmHg (30 mmHg) (-580 mmHg)
be preset (Default) Minimum 75 mmHg absolute pressure

8.1.8 Dialysis fluid preparation (BiCart Select concentrate system mode


only)
Table 8-11. Fluid flow
1 L SelectBag concentrate Proportioning 1:200 (3 %)
Ratio 1 L SelectBag concentrate Proportioning Ratio
is defined as the quotient 1 L SelectBag
concentrate flow/dialysis fluid flow

Table 8-12. On-line Saline Priming (OSP)


Sodium concentration 154 mmol/l (4 mmol/l)

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8.1.9 Ultrafiltration control
Table 8-13. Volume control
UF volume max. 30 litres (50 ml or 50 ml * passed
treatment time (h) or 2.5 %)
UF-rate 0.0 to 4.0 l/h
Treatment Time 0.05 to 9.59 hour.minute (1 minute)

Table 8-14. Pressure control (On-line mode)


Constant TMP in on-line mode, where TMP for the AK 200 ULTRA S dialysis machine is
defined as the difference, Pb out - Pd out, where Pb out is the venous drip chamber pressure
and Pd out is the pressure measured in the dialysis fluid, where it enters the machine after the
dialyzer.
8 Technical data and specifications -
AK 200 ULTRA S dialysis machine

TMP -200 to +550 mmHg (15 mmHg)

8.1.10 Substitution fluid


Substitution fluid flow rate 0.3 to 27.0 litres/h (10 %) at 500 ml/min flow
rate. Limitations at lower flow rates.
Substitution volume max. 150 litres

8.1.11 Profiling
UF-rate 0 to 4 l/h
Na+, Acetate mode 115 to 160 mmol/l
Na+, Bicarbonate mode 130 to 150 mmol/l
HCO3-, Bicarbonate mode 20 to 40 mmol/l

Table 8-15. Half-times


Degressive Set in h.min, 10 to 25 % of remaining
treatment time
Progressive Set in h.min, 75 to 90 % of remaining
treatment time

8.1.12 Diascan
Accuracy is valid in HD mode double needle treatment and on-line HDF mode double
needle treatment, for blood flows 200 to 500 ml/min and fluid flows 500 to 700 ml/min,
UF profiling is allowed.
Clearance, K 0 to 350 ml/min (10 %)
Cumulated water volume cleared of urea, Kt 0 to 100 l (10 %)
Dialysis dose, Kt/V 0 to 3 (10 %)
Plasma sodium, Na+ 130 to 160 mmol/l

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176 Technical data and specifications - AK 200 ULTRA S
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8.1.13 Disinfection and Cleaning
Temperature and time in different phases and concentration of disinfectant are
possible to preset. The values in this specification are the default values and what the
machine has been validated against. Follow the instructions from the manufacturer of
the disinfectant, to set the correct dilution and dwell time. All disinfection programs in
the AK 200 ULTRA S dialysis machine are tested in accordance with the French
standard NFS 90-304 and established to fulfil the requirements expressed in the same
standard. Time for disinfection programs is estimated and may vary.
All values below are applicable for the 230V AC variant. For the 115V AC variant add 7
minutes to all heating programs.

Table 8-16. Heat disinfection Program


Temperature 93 C

8 Technical data and specifications -


AK 200 ULTRA S dialysis machine
Fill up phase 13 minutes
Circulation phase 15 minutes
Drain phase 4 minutes
Total time 32 minutes

Table 8-17. Heat disinfection Program with CleanCart cartridge


Decalcification CleanCart C
Cleaning CleanCart A
Temperature 93 C
Fill up and mixing phase 13 minutes
Circulation phase 15 minutes
Rinse/Drain phase 11 minutes
Total time 39 minutes

Table 8-18. Heat disinfection Program with liquid citric acid


Temperature 93 C
Concentration 20 % citric acid
Concentration in machine 2 % citric acid; i.e. diluted 1 + 9
Consumption Approx 260 ml
Fill up and mixing phase 19 minutes
Circulation phase 15 minutes
Rinse/Drain phase 10 minutes
Total time 44 minutes

Table 8-19. Heat disinfection Program with WRO 300 H


Temperature 93 C
Fill up phase 13 minutes
Circulation phase 15 minutes
Low flow heat phase 20 minutes
Drain phase 4 minutes
Total time 52 minutes

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Technical data and specifications - AK 200 ULTRA S 177
dialysis machine
Table 8-20. Heat disinfection Program with CleanCart cartridge including WRO 300 H
Decalcification CleanCart C
Cleaning CleanCart A
Temperature 93 C
Fill up phase 13 minutes
Circulation phase 15 minutes
Low flow heat phase 20 minutes
Rinse/Drain phase 11 minutes
Total time 59 minutes

Table 8-21. Peracetic Acid Program


8 Technical data and specifications -
AK 200 ULTRA S dialysis machine

Concentration of disinfectant 3.5 % peracetic acid


Concentration in machine 0.1 % ; i.e. diluted 1 + 34
Consumption Approx. 85 ml
Fill up and mixing phase 17 minutes
Dwell time 10 minutes
Rinse/Drain phase 43 minutes
Total time 70 minutes including 10 min dwell time

Table 8-22. Low concentration Peracetic Acid Program


Concentration of disinfectant 0.35 % peracetic acid
Concentration in machine 0.01 %; i.e. diluted 1 + 34
Consumption Approx. 85 ml
Fill up and mixing phase 17 minutes
Dwell time 10 minutes
Rinse/Drain phase 28 minutes
Total time 55 minutes including 10 min dwell

Table 8-23. Hypochlorite Program


Concentration of disinfectant 0.5 % available chlorine (approximately 70 %
of sodium hypochlorite concentration)
Concentration in machine 0.5 % ; i.e. not diluted
Consumption Approx. 3000 ml
Fill up and mixing phase 25 minutes
Dwell time 10 minutes, Maximum 20 min
Rinse/Drain phase 39 minutes
Total time 74 minutes including 10 min dwell time

Table 8-24. Central Chemical Disinfection Program


Concentration of disinfectant 0.1 % peracetic acid or 0.5 % available
chlorine
Concentration in machine Not diluted
Consumption Approx. 4100 ml
Dwell time Must be preset, maximum 20 min. for
hypochlorite
Total time 64 minutes (dwell time not included)

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178 Technical data and specifications - AK 200 ULTRA S
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Table 8-25. Other programs, total time
Rinse/Drain 13 min
Drain 4 min

External Cleaning 70 % Ethanol or 60 % Isopropanol

8.1.14 Water supply


Table 8-26. Water Supply Flow Rate
Treatment 450 to 850 ml/min
Disinfection 0 to 900 ml/min

8 Technical data and specifications -


AK 200 ULTRA S dialysis machine
Table 8-27. Inlet Water Pressure
To regulator 120 to 800 kPa
To machine 85 to 120 kPa

Table 8-28. Inlet Water Temperature


Treatment +5 to +30 C
Disinfection +5 to +90 C

Table 8-29. Inlet Water Quality


Inlet water quality must comply with local regulations and if no such regulation is available
follow ISO 13959. Level for conductivity shall not exceed 0.1 mS/cm. It is possible to use water
with higher conductivity if it consists mainly of sodium salts. This may however affect the
accuracy of the fluid composition.

Table 8-30. Inlet tube length


Maximum 5 m or the specially designed spiral PEX tubing

8.1.15 Drain
Drain (length of tube) Maximum 5 m
Drain capacity Minimum 1.0 l/min
Drain outlet Maximum 1.2 m above floor

If the optional air-gap on the machine is used the distance between the air-gap and the
drain must not be less than 0.3 m. For an electrically adjustable stand in its lowest
position this means that the drain must not be higher than 580 mm. For a mechanically
adjustable stand in its lowest position the drain must not be higher than 550 mm.

8.1.16 Power supply


Mains Voltage 115 or 230 V AC (10 %)
Frequency 50 or 60 Hz (5 Hz)
Power Consumption Max. 2250 W at 230 V
Max. 1650 W at 115 V
Mains cable 3 conductor cable, Length max. 3 m rating 250
V 10 A, 13 -16A
Mains cable connector Certified to IEC 60320/C19

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Technical data and specifications - AK 200 ULTRA S 179
dialysis machine
Mains cable plug Plug with protective earth, 250 V AC / 13 -16
A, or Hospital grade plug with protective earth,
125 V AC / 15 A.
Earth Leakage Current max 500 A
Patient Leakage Current max 100 A
Fuses 2 x T 10 A

All leakage currents are specified without external equipment connected to the
machine.

8.1.17 Connection of external equipment


Additional equipment connected to medical electrical equipment must comply with the
8 Technical data and specifications -
AK 200 ULTRA S dialysis machine

respective IEC or ISO standards (e.g. IEC 60950 for data processing equipment).
Furthermore all configurations shall comply with the requirements for medical electrical
systems (see IEC 6060111 or clause 16 of the 3Ed. of IEC 606011, respectively).
Anybody connecting additional equipment to medical electrical equipment configures a
medical system and is therefore responsible that the system complies with the
requirements for medical electrical systems. Attention is drawn to the fact that local
laws take priority over the above mentioned requirements. If in doubt, consult your
local representative or the technical service department. Use of other cables may
result in increased emissions or decreased immunity for the equipment or system.
Protective caps shall be attached when the connectors are not in use.

Table 8-31. External serial interface


External connector P 63 8 pin REDEL contact, black. RS-232 or
RS-422 compatible connection. Opto insulated
fulfilling IEC 60601-1-1. Attached cable length
2.5 m unshielded.
External equipment Serial port for connection to PC used for
logging and preset.

Table 8-32. RS-232


Max input voltage 15 V DC
High level min output voltage +5 V DC
Low level max output voltage -5 V DC
Max output current 5 mA

Table 8-33. RS-422


Max input voltage 7 V DC
Diff. input threshold voltage 0.2 V DC
Diff. max. output voltage 5 V DC
Diff. min. output voltage 2 V DC
Short circuit output current 100 mA

Table 8-34. External interface


External connector P 79 8 pin REDEL, yellow, configured as 1 make-
and 2 change over- relay contacts. Attached
cable length 2.9 m unshielded.
External equipment Port for connection to central alarm system
and remote control of water system.

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180 Technical data and specifications - AK 200 ULTRA S
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Table 8-35. Contact ratings
Max voltage 24 V AC or DC
Max current 100 mA AC or DC

Table 8-36. External I/O interface


External connector P 76 8 pin REDEL blue. Opto insulated fulfilling IEC
60601-1-1. Attached cable length 1.5 m
unshielded.
External equipment Connection to Gambro UF Calibration Unit.
Service purpose only.

Table 8-37. External interface

8 Technical data and specifications -


AK 200 ULTRA S dialysis machine
External connector P 64 8 pin RJ-45
External equipment Ethernet port for connection to network only
intended for Exalis computer system,
download, preset and logging

8.1.18 Battery Back-up


Battery back-up of power supply 24 volt, 6.5 Ah
Running time >15 minutes
Fuse T 15 A

8.2 Performance and specification - Supervisory system

8.2.1 Valid accuracy range


NOTE!
When accuracy ranges are written as e.g. (1 ml/min or 1 %) the widest range is
valid.

8.2.2 Blood Pressure Supervision


The alarm limits below can be preset. The value put in brackets and in italics is the
default value.

Table 8-38. Venous Pressure


Operating range -700 to +750 mmHg
(10 % at -700 to -500 mmHg)
(5 mmHg or 3 % at -500 to +500 mmHg)
(10 % at +500 to +750 mmHg)
Alarm limit HIGH max +600 mmHg (+300 mmHg)
Alarm limit LOW min -50 mmHg (-50 mmHg)
When blood is detected the operator is
requested to centralize the alarm limits and the
low limit is by default set to +10 mmHg

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Technical data and specifications - AK 200 ULTRA S 181
dialysis machine
Table 8-39. Arterial Pressure
Operating range -700 to +750 mmHg
(10 % at -700 to -500 mmHg)
(5 mmHg or 3 % at -500 to +500 mmHg)
(10 % at +500 to +750 mmHg)
Alarm limit HIGH max +750 mmHg (+250 mmHg)
Alarm limit LOW min -700 mmHg (-250 mmHg)

Table 8-40. System Pressure


Operating range -700 to +750 mmHg
(10 % at -700 to -500 mmHg)
8 Technical data and specifications -
AK 200 ULTRA S dialysis machine

(5 mmHg or 3 % at -500 to +500 mmHg)


(10 % at +500 to +750 mmHg)
Alarm limit SN/DP HIGH max +300 mmHg (+175 mmHg)
Alarm limit SN/DP LOW min -200 mmHg (+10 mmHg)
Alarm limit SP HIGH max +750 mmHg (+150 mmHg)
Alarm limit SP LOW min -

8.2.3 Air Detection


Sensitivity Bubbles larger than 1l will be trapped by the
drip chamber. An alarm will be issued if the
blood level falls below the middle of the air
detector.
Venous drip chamber size (diameter) 22mm

8.2.4 Heparin Administration


Heparinization volume alarm limit 0.3 ml of set value (1 ml or 0.2 ml *
heparinization time (h) or 5 %)

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

8.2.5 Dialysis fluid preparation


Table 8-41. Temperature
Low temperature alarm limit 32.5 C (+0.5/-2.0 C)
High temperature alarm limit 41.5 C (+0.5/-2.7 C)

Table 8-42. Conductivity


Alarm limits in Acetate mode 5 % of set value
Alarm Limit in Bicarbonate mode, A-step 5 % of set value for A-step conductivity
(acidic)
Alarm Limit in Bicarbonate mode, B-step 5 % of set value for B-step conductivity
(bicarbonate)

Alarm limits are temporarily extended to 10 %. Maximum mean deviation for a 5 hour
treatment is 0.2 mS/cm.

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182 Technical data and specifications - AK 200 ULTRA S
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8.2.6 Dialysis fluid preparation (BiCart Select concentrate system mode
only)
Dialysis Fluid Flow Rate 300 - 700 ml/min (9 ml/min)
Dialysis Fluid Flow Rate alarm limit 5 %
1 L SelectBag concentrate Proportioning Ratio 1:200 12 %, alarm given within 20 minutes.
alarm limit For larger errors the alarm time is shorter.
1 L SelectBag concentrate Proportioning Ratio
is defined as the quotient 1 L SelectBag
concentrate flow/dialysis fluid flow

8.2.7 Ultrafiltration

8 Technical data and specifications -


Dialysis fluid flow operating range 300 - 700 ml/min

AK 200 ULTRA S dialysis machine


UF rate measurement -4.0 to +4.0 l/h (2 ml/min). Accuracy 5
ml/min verified at start-up.
UF rate supervision, max allowed difference 1-10 ml/min, ( 5 ml/min)
between control and protective system, can be
preset (Default)
Accumulated UF volume alarm limit (Default) 200 ml, or 70 - 130 ml/h ( 130 ml/h) *
passed treatment time (h), whichever is
greatest.
Treatment Time Control 0.05 to 9.59 hour.minute (1 minute)
TMP supervision alarm -200 to +550 mmHg (15 mmHg) For
AK 200 ULTRA S dialysis machine, TMP is
defined as Pb out - Pd out + Offset, where Pb
out is the venous drip chamber pressure and
Pd out is the pressure measured in the dialysis
fluid, where it enters the machine after the
dialyzer. The offset compensates for the
vertical distance between the pressure sensors.
Max UF rate alarm limit, can be preset 0.1 to 4.0 l/h (1.0 l/h)
(Default) In TMP on-line mode with settable substitution
fluid volume only.

8.2.8 Blood leak detection


Sensitivity 0.15 ml blood/min at 300 ml/min dialysis fluid
flow rate
0.35 ml blood/min at 700 ml/min dialysis fluid
flow rate
haematocrit 32 % 2 %
Alarm response time (diffusion mode) 7 seconds

8.2.9 Blood loss due to coagulation


Supervision of blood pump stop time (Default) 10 to 180 seconds (60 seconds)

8.3 Physical data


Depth Approx. 610 mm
Width Approx. 570 mm

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Technical data and specifications - AK 200 ULTRA S 183
dialysis machine
Total Height Adjustable heights 1175 - 1340 mm
Five position stand 1152 - 1382 mm
Floor Area 573 x 753 mm
Weight Blood Monitor Approx. 17 kg
Weight Fluid Monitor Approx. 40 kg
Weight Stand Approx. 24 to 31 kg
Total Weight Approx. 81 to 88 kg
Infusion Stand Height 1300 to 2150 mm
Max. load 10 kg
Transportation One man installation
Fitting into a normal Estate car
8 Technical data and specifications -
AK 200 ULTRA S dialysis machine

References
Assembly Drawing, K22200

8.4 Materials in contact with water, concentrates and dialysis


fluid

8.4.1 Polymers
Silicon rubber
Santroprene
PVC (Polyvinylchloride)
PEEK (Polyetherketone)
PEX (Polyethylene)
PP (Polypropylene)
PP (Polypropylene reinforced with talcum)
PSU (Polysulphone)
PVDF (Polyvinylidene fluoride)
PTFE (Polytetrafluoro ethylene)
Parylene C

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

8.4.3 Others
Carbon
Ceramic, Steatite 221
Ceramic, Aluminum oxide (Al2O3)

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184 Technical data and specifications - AK 200 ULTRA S
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Ceramic, Zirconium oxide (ZrO2)
Glass
Barium Ferrite

8.5 Environmental data

8.5.1 Operation
If condensation occur when moving the equipment between locations with different
temperatures and high relative humidity (e.g. outdoor and indoor locations), the inside
of the equipment shall be allowed to dry before switching on the equipment.

8 Technical data and specifications -


AK 200 ULTRA S dialysis machine
Ambient Temperature range +18 to +35 C
Relative Humidity range 15 to 85 % RH
Air Pressure range (atm. pressure) 700 to 1060 hPa
Maximum altitude 2000 m above sea level

8.5.2 Transportation and storage


During transportation and storage the equipment has to be kept in its original packing.
If transportation or storage time is more than 15 weeks, the environmental data
relating to the operation has to be followed. The maximum ambient temperature for
transportation and storage in 96 % Relative humidity is +40 C.
Ambient Temperature range -20 to +70 C
Relative Humidity range 10 to 96 % RH
Air Pressure range (atm. pressure) 500 to 1060 hPa
Maximum altitude 2000 m above sea level

8.5.3 Energy
Typical energy consumption for a 4 hour treatment with inlet water temperature of 5 C
and 500 ml/h main flow is 2.7 kWh. Energy delivery to the environment is
approximately 400 Wh independent of inlet water temperature.
Energy delivery to the drain during a 4 hour treatment is 2.3 kWh.
The temperature at the drain can be up to 80 C.
Power consumption and delivery to the drain decrease with approximately 19 W for
every degree increase of inlet water temperature.

8.5.4 Electromagnetic environment


The AK 200 ULTRA S dialysis machine is intended for use in the electromagnetic
environment specified below. The customer or the user of the AK 200 ULTRA S
dialysis machine should assure that it is used in such an environment.

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Technical data and specifications - AK 200 ULTRA S 185
dialysis machine
Emissions test Compliance Electromagnetic environment
guidance
RF emissions Group 1 The AK 200 ULTRA S dialysis machine
CISPR 11 uses RF energy only for its internal
function. Therefore, its RF emissions are
very low and are not likely to cause any
interference in nearby electronic
equipment.
RF emissions Class B The AK 200 ULTRA S dialysis machine is
CISPR 11 suitable for use in all establishments,
including domestic establishments and
those directly connected to the public
low-voltage power supply network that
supplies buildings used for domestic
8 Technical data and specifications -
AK 200 ULTRA S dialysis machine

purposes.
Harmonic emissions Class A (Not applicable for 115
IEC 61000-3-2 V version)

Voltage fluctuations /flicker Complies (Not applicable for


emissions 115 V version)
IEC 61000-3-3

Immunity test IEC 60601 Compliance level Electromagnetic


test level environment-guidance
Electrostatic discharge 6 kV contact 6 kV contact Floors should be wood,
(ESD), 8 kV Air 8 kV Air concrete or ceramic tile. If
IEC 61000-4-2 floors are covered with
synthetic material, the
relative humidity should
be at least 30 %.
Electrical fast 2 kV for power lines 2 kV for power lines Mains power quality
transient/burst, 1 kV for input/output 1 kV for input/output should be that of a typical
IEC 61000-4-4 lines lines commercial or hospital
environment.
Surge 1 kV for differential mode 1 kV for differential mode Mains power quality
IEC 61000-4-5 2 kV for common mode 2 kV for common mode should be that of a typical
commercial or hospital
environment.
Voltage dips, short <5 % UT <5 % UT Mains power quality
interruptions and voltage (>95 % dip in UT) (>95 % dip in UT) should be that of a typical
variations on power commercial or hospital
for 0.5 cycle for 0.5 cycle
supply input lines. environment. If the user of
40 % UT 40 % UT the AK 200 ULTRA S
IEC 61000-4-11
(60 % dip in UT) (60 % dip in UT) dialysis machine requires
for 5 cycles for 5 cycles continued operation
during power mains
70 % UT 70 % UT interruptions, it is
(30 % dip in UT) (30 % dip in UT) recommended that the
for 25 cycles for 25 cycles AK 200 ULTRA S dialysis
machine be powered from
<5 % UT <5 % UT
an uninterruptible power
(>95 % dip in UT) (>95 % dip in UT) supply or a battery.
for 5 sec for 5 sec
Power frequency (50/60 3 A/m 3 A/m Power frequency
Hz) magnetic field magnetic fields should be
IEC 61000-4-8 at levels characteristic of
a typical location in a
typical commercial or
hospital environment.

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186 Technical data and specifications - AK 200 ULTRA S
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NOTE!
UT is the a.c. mains voltage prior to application of the test level.
Immunity test IEC 60601 Compliance Electromagnetic enviroment-guidance
test level level
Portable and mobile RF communications
equipment should be used no closer to any part of
the AK 200 ULTRA S dialysis machine, including
cables, than the recommended separation distance
calculated from the equation applicable to the
frequency of the transmitter.
Recommended separation distance
Conducted RF 3 Vrms 3V

8 Technical data and specifications -


IEC 61000-4-6 150 kHz to 80

AK 200 ULTRA S dialysis machine


MHz

Radiated RF 3 V/m 3 V/m


IEC 61000-4-3 80 MHz to 2.5
GHz

80 MHz to 800

800 MHz to 2.5 GHz


Radiated RF - 30 V/m where P is the maximum output power rating of the
mobile phones transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended
separation distance in meters (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site surveya,
should be less than the compliance level in each
frequency rangeb.
Interference may occur in the vicinity of equipment
marked with the following symbol:

aFieldstrengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile
radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To
assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the AK 200 ULTRA S dialysis machine is used exceeds
the applicable RF compliance level above, the AK 200 ULTRA S dialysis machine should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating
the AK 200 ULTRA S dialysis machine.
bOver the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

NOTE!
At 80 MHz and 800 MHz, the higher frequency range applies.
These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.

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Technical data and specifications - AK 200 ULTRA S 187
dialysis machine
Recommended separation distances between portable and mobile RF communications equipment
and the AK 200 ULTRA S dialysis machine
The AK 200 ULTRA S dialysis machine is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of the AK 200 ULTRA S dialysis machine
can help prevent electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and the AK 200 ULTRA S dialysis machine as
recommended below, according to the maximum output power of the communications equipment.
Rated maximum output Separation distance according to frequency of transmitter
power of transmitter (m)
W
150kHz - 80MHz 80MHz - 800MHz 800MHz - 2500MHz
8 Technical data and specifications -
AK 200 ULTRA S dialysis machine

0.01 0.11 0.11 0.23


0.1 0.37 0.37 0.74
1 1.2 1.2 2.3
10 3.7 3.7 7.4
100 12 12 23
Rated maximum output - -
power of mobile phone

2W - - 0.33
GSM/3G
For transmitters rated at a maximum output power not listed above, the recommended separation distance d
in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is
the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE!
At 80 MHz and 800 MHz, the separation distance for the higher frequency range
applies.
These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.

8.6 Standards
The machine complies with the following standards:
IEC 60601-1 General requirements for safety, Class I, type B
IEC 60601-2-16 Particular requirements for safety of haemodialysis, haemodiafiltration
and haemofiltration equipment
IEC 60601-2-30 Particular requirements for the safety of automatic cycling indirect
blood pressure monitoring equipment
IEC 60601-1-2 Electromagnetic compatibility
EN 1060-1 Non-invasive sphygmomanometers Part 1: General requirements
EN 1060-3 Non-invasive sphygmomanometers Part 3: Supplementary requirements
for electromechanical blood pressure measuring systems
NFS 90-304 Medico-surgical equipment Hemodialysis equipment

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188 Technical data and specifications - AK 200 ULTRA S
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9 Electrical Safety Inspection
9.1 General ....................................................................................................................... 190

9.2 Visual inspection ....................................................................................................... 190

9.3 PET - Protective Earth Test....................................................................................... 191


9.3.1 Test equipment for PET - Protective Earth Test..................................................... 191
9.3.2 PET (Protective Earth Test) for AK 95 S dialysis machines............................... 191
9.3.3 PET (Protective Earth Test) for AK 96 dialysis machine ..................................... 191
9.3.4 PET (Protective Earth Test) for AK 200 S / AK 200 ULTRA S dialysis
machines ........................................................................................................... 192

9.4 ELT / PLT..................................................................................................................... 192


9.4.1 Test equipment for ELT / PLT ................................................................................ 192
9.4.2 General conditions for ELT / PLT........................................................................... 192
9.4.3 ELT - Earth Leakage Current Test ......................................................................... 193
9.4.4 PLT - Patient Leakage Current Test ...................................................................... 194

9.5 Record of Electrical Safety Inspection .................................................................... 196

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Electrical Safety Inspection 189
9.1 General
Toensureproperoperation,aqualifiedservicetechnicianshallperform an Electrical
Safety Inspection (ESI) of the dialysis machine at regular intervals.ESI should be
performed at every maintenance service (Base-service) but also after replacements of
some components in the dialysis machine according to the Service Manual, see
Section 4 Replacements on page74.
Additionally if the equipment has been exposed to unexpected electrical events on the
main supply or unintentional ingress of fluid has occurred, a full Electrical Safety
Inspection shall be performed.The information needed to perform ESI is provided in
thisinstruction.
Included in the ESI procedures are checks to verify normal machine operation. Should
the machine fail to pass any of these sub-tests, repair or calibration might be needed,
then repeat the tests until the specifications are met.
Following sub-tests are included in the ESI of the dialysis machines:
Visual inspection
PET - Protective earth test
ELT - Earth leakage current test
PLT - Patient leakage current test
To avoid premature aging of isolation material no insulation test shall be performed
during ESI. Spare parts dependent on insulation are tested at manufacturing and
9 Electrical Safety Inspection

therefore no further test shall be performed with high voltage.


During the visual inspection of the equipment, the service engineer shall look for
potential faults related to the electrical safety of the machine.
The purpose of the PET test is to verify that the protective earthed parts of the
machine are properly connected to protective earth, providing a safe low electrical
potential on these in case of insulation failure.
The purposes of the ELT/PLT tests are to verify that non-functional leakage currents to
operator and patient are within safe limits.
When performing the ESI, which requires access to the interior of the machine, the
service technician shall have proper electrostatic safety devices (i.e. wrist grounding
straps or grounding mats) in place to prevent damage to electrostatic sensitive
components within the machine.

During repair of any of the parts in the flow path, special care should be taken and a
good hygiene should be kept.
Recordsforeach sub-testareincluded inthe end ofthisinstruction. The purpose of
these records is to documentthe work done and to trend the readings from the tests.

NOTE!
If the machine is tested according to IEC 60601-11, this complies with the
requirements in IEC 623532.

9.2 Visual inspection


The visual inspection is an important part of the Electrical Safety Inspection of the
dialysis machine.

1 IEC 60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential
performance.
2 IEC 62353: Medical electrical equipment - Recurrent test and test after repair of medical electrical
equipment.

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190 Electrical Safety Inspection
The visual inspection is a procedure to make sure that the medical equipment in use
still confirms the specifications and has not suffered from any external damage and/or
contamination.
Procedure
1) Exterior parts including covers: look for major damages, cracks etc.
2) Cabling: look for cuts, wrong connections etc.
3) Fuse rating: check correct values after replacement.
4) Markings and labelling: check the integrity.
5) Integrity of mechanical parts: check for any visual obstructions.

9.3 PET - Protective Earth Test

9.3.1 Test equipment for PET - Protective Earth Test


NOTE!
The machine shall not be connected to mains power during this test.

NOTE!
Limit values for PET-test according to IEC 62353.
Use test equipment according to IEC 62353.

9 Electrical Safety Inspection


9.3.2 PET (Protective Earth Test) for AK 95 S dialysis machines
Check that the resistance between the protective earth connection of the mains plug
and the following items does not exceed 300 m:
1. The exterior cover of the power supply
2. The heater rod
3. The suction pump
4. The mounting plate to the Diascan system conductivity cell
5. The stand of MM 95 (e.g. a screw to the heat exchangers)
6. The front of MM 95 (e.g. a screw to the BiCart cartridge holder)
7. The heparin pump (rear plate)
8. The potential equalization connector

9.3.3 PET (Protective Earth Test) for AK 96 dialysis machine


Check that the resistance between the protective earth connection of the mains plug
and the following items does not exceed 300 m:
1. The exterior cover of the power supply
2. The heater rod
3. The mounting plate for the suction pump, measure on one of the screws
4. The mounting plate for the flow pump, measure on one of the screws
5. The mounting plate to the safety couplings for the dialysis fluid tubes
6. The pressure regulator, PR1
7. The mounting plate to the water inlet/drain-nipples, measure on one of the screws
8. The mounting plate to the external communication port, measure on one of the
screws

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Electrical Safety Inspection 191
9. The mounting plate to the potential equalization connector, measure on one of the
screws
10. The potential equalization connector
11. The heparin pump (rear plate)

9.3.4 PET (Protective Earth Test) for AK 200 S / AK 200 ULTRA S


dialysis machines
Check that the resistance between the protective earth connection of the mains plug
and the following items does not exceed 300 m:
1. The power supply (right side, through the vent holes of the bottom box)
2. The FM bottom plate
3. The heater rods outside the heating vessel
4. For 115 V machines: Also check that the resistance between the protective earth
connection of the mains plug for the heater rods and the heater rods outside the
heating vessel
5. The overheat protection of the heater rods
6. The potential equalization connector
7. The heparin pump (rear plate, do not measure on the cable clip or its binding
screw)
8. The rear plate of the BVS unit
9 Electrical Safety Inspection

9.4 ELT / PLT

9.4.1 Test equipment for ELT / PLT


To do the PET, you need the following equipment:
Safety Tester, set to measure according to IEC 60601-1.
PLT box K40246001.

9.4.2 General conditions for ELT / PLT


If several machines are connected together in a system, the sum of each machine ELT
and PLT values shall be less than the maximum values shown in the tables.
Procedure
1) The dialysis machine shall be connected to both feed water and drain.
2) Perform the test with all enclosure parts of the machine assembled.
3) Connect the dialysis machine to the outlet supply of the safety tester. Use a mains
plug adapter for respective mains plug. If the dialysis machine is equipped with
two mains plugs, the measurements shall be performed for each mains plug and
the values shall be added.

NOTE!
To avoid damages on the safety tester, follow the instructions for the safety
tester.

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192 Electrical Safety Inspection
4) Central concentrate delivery systems should not be used. Use either liquid or
non-liquid concentrates.
5) No other external equipment than specified in this instruction should be connected
to the machine.
6) The protective earth of the machine shall not be in contact with any external
protective earth.

9 Electrical Safety Inspection


7) No Potential Equalization cable shall be connected during test.

9.4.3 ELT - Earth Leakage Current Test


Procedure
1) Let the machine pass FCH.
2) Measure the earth leakage current with the safety tester. Measure both in N.C.
(Normal Condition) and S.F.C. (Single Fault Condition).
3) Take the highest reading when the machine is running.
4) Invert the phases of the mains voltage. The machine might restart.
5) Take the highest reading when the machine is running. Measure both in N.C.
(Normal Condition) and S.F.C. (Single Fault Condition).
6) Check that the highest measured readings do not exceed the limit values in the
table below.

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Electrical Safety Inspection 193
Results

Table 9-1. Limit values for earth leakage current (ELT)


ELT Limit values
N.C. S.F.C.
AK 95 S (100 V, 110 V) Max 500 A Max 1000 A
AK 96 (115 V)
AK 200 S (115 V).a
AK 200 ULTRA S (115 V).a
AK 95 S, AK 96 (230 V)
AK 200 S (230 V)
AK 200 ULTRA S (230 V)
aThe total earth leakage current is the sum of the readings from both mains cables (to the heater rods
and to the ACDC).

9.4.4 PLT - Patient Leakage Current Test


NOTE!
Make sure that the machine does not perform a taration (self calibration) during the
measurements.
Procedure
9 Electrical Safety Inspection

1) Let the machine pass FCH.


2) Connect the dialysis fluid tubes to the PLT box.
3) The access point on the PLT box shall be connected to the Safety Tester.

4) There must be a fluid flow during this test. Make sure that the fluid is not in
bypass.
5) Measure the patient leakage current with the safety tester. Follow the user manual
for the safety tester .
6) Measure both in N.C. (Normal Condition) and S.F.C. (Single Fault Condition).
7) Take the highest AC-reading when the machine is running.
8) Take the highest DC-reading when the machine is running.
9) Invert the phases of the mains voltage. The machine may restart.

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194 Electrical Safety Inspection
10) Measure both in N.C. (Normal Condition) and S.F.C. (Single Fault Condition).
11) Take the highest AC-reading when the machine is running.
12) Take the highest DC-reading when the machine is running.
13) Check that the highest measured readings do not exceed the limit values in Table
9-2 Limit values for patient leakage current (PLT) on page195.

Table 9-2. Limit values for patient leakage current (PLT)


PLT Limit values
AC N.C. DC N.C. AC S.F.C. DC S.F.C.
AK 95 S (100 V,
110 V)
AK 96 (115 V)
AK 200 S (115
V).a
AK 200 ULTRA S
(115 V).a Max 100* A. Max 10 A Max 500 A Max 50 A
AK 95 S, AK 96
(230 V)
AK 200 S (230
V)
AK 200 ULTRA S

9 Electrical Safety Inspection


(230 V)
aThe total patient leakage current is the sum of the readings from both safety testers.

NOTE!
* For treatments with a central venous catheter (CVC), the patient leakage
current shall be < 10 A AC at Normal Condition (N.C.).

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Electrical Safety Inspection 195
9.5 Record of Electrical Safety Inspection
Machine type
AK 95 S AK 96
AK 200 S AK 200 ULTRA S

Machine identification
Product code
Serial number
Run time (h)

Visual inspection Approved check


A visual inspection of the dialysis machine has
been performed without any remarks,
according to the specified step instruction in
Section 9.2 Visual inspection on page190

Remarks:
9 Electrical Safety Inspection

Table 9-3. PET for AK 95 S dialysis machines


Check no Description Measured Approved
value check
Check that the resistance between the protective earth
connection of the mains plug and...
1 ...the exterior cover of the power supply... . m
2 ...the heater rod... . m
3 ...the suction pump... . m
4 ...the mounting plate to the Diascan system conductivity . m
cell...
5 ...the stand of MM 95 (e.g. a screw to the heat . m
exchangers)...
6 ...the front of MM 95 (e.g. a screw to the BiCart cartridge . m
holder)...
7 ...the heparin pump (rear plate)... . m
8 ...the potential equalization connector... . m
...does not exceed 300 m.

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196 Electrical Safety Inspection
Table 9-4. PET for AK 96 dialysis machine
Check no Description Measured Approved
value check
Check that the resistance between the protective earth
connection of the mains plug and...
1 ...the exterior cover of the power supply... . m
2 ...the heater rod... . m
3 ...the mounting plate for the suction pump, measure on . m
one of the screws,...
4 ...the mounting plate for the flow pump, measure on one . m
of the screws,...
5 ...the mounting plate to the safety couplings for the . m
dialysis fluid tubes...
6 ...the pressure regulator, PR1,... . m
7 ...the mounting plate to the water inlet/drain-nipples, . m
measure on one of the screws,...
8 ...the mounting plate to the external communication port, . m
measure on one of the screws,...
9 ...the mounting plate to the potential equalization . m
connector, measure on one of the screws,...
10 ...the potential equalization connector... . m

9 Electrical Safety Inspection


11 ...the heparin pump (rear plate)... . m
...does not exceed 300 m.

Table 9-5. PET for AK 200 S / AK 200 ULTRA S dialysis machines


Check no Description Measured Approved
value check
Check that the resistance between the protective earth
connection of the mains plug and...
1 ...the power supply (right side, through the vent holes of . m
the bottom box)...
2 ...the FM bottom plate... . m
3 ...the heater rods outside the heating vessel...
4 For 115 V machines: Check that the resistance between . m
the protective earth connection of the mains plug for the
heater rods and the heater rods outside the heating
vessel...
5 ...the overheat protection of the heater rods... . m
6 ...the potential equalization connector... . m
7 ...the heparin pump (rear plate, do not measure on the . m
cable clip or its binding screw)...
8 ...the rear plate of the BVS-unit... . m
...does not exceed 300 m.

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Electrical Safety Inspection 197
Table 9-6. ELT - Earth Leakage Current Test
Description Measured value Approved check
File the highest measured . A
earth leakage current, normal
condition (N.C.) reading
according to Section 9.4.3
ELT - Earth Leakage Current
Test on page193.
File the highest measured . A
earth leakage current, single
fault condition (S.F.C.) reading
according to Section 9.4.3
ELT - Earth Leakage Current
Test on page193.

Table 9-7. PLT - Patient Leakage Current Test


Description Measured value Approved check
File the highest measured . A DC
patient leakage current,
. A AC
normal condition (N.C.)
reading according to Section
9.4.4 PLT - Patient Leakage
Current Test on page194.
9 Electrical Safety Inspection

File the highest measured . A DC


patient leakage current, single
. A AC
fault condition (S.F.C.) reading
according to Section 9.4.4
PLT - Patient Leakage
Current Test on page194.

File both the highest AC-reading and the highest DC-reading, when the machine is
running, according to the section PLT - Patient Leakage Current Test in this chapter.
Compare with the measured leakage currents at the last1 ESI and evaluate if the
changes are approved or not for the next operational period of the machine.
Write notes below:
Notes:

Name of testing organization Date

Name of testing Service engineer Signature

This record is to be signed and filed by the Service Engineer responsible for the
Electrical Safety Inspection

1 If this is the ESI at installation please make comparison with the Production Summary measured values
supplied by the manufacturer at delivery of the machine.

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198 Electrical Safety Inspection
10 Wiring diagram

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Wiring diagram 199
11 Calibration manual
11.1 General ....................................................................................................................... 203

11.2 Calibration, Fluid Monitor ......................................................................................... 203


11.2.1 Technical Facilities................................................................................................. 203
11.2.2 A/D Converter FM (CPU Q), FM 21....................................................................... 204
11.2.3 A/D Converter FM (CPU F;1), FM 22 .................................................................... 205
11.2.4 A/D Converter FM (CPU F;2), FM 23 .................................................................... 206
11.2.5 Temperature FM CPU Board calibration, FM 0 ..................................................... 207
11.2.6 Degassing Transducer calibration, FM 7 ............................................................... 208
11.2.7 Flow Output Pressure Transducer calibration, FM 8 ............................................. 209
11.2.8 Flow Input Pressure Transducer calibration, FM 9 ................................................ 211
11.2.9 High Pressure Guard Transducer calibration, FM 10 ............................................ 212
11.2.10 Dialysis Fluid Pressure Transducer (PD) calibration, FM 11 ................................. 214
11.2.11 Safety Guard Pressure Transducer calibration, FM 12 ......................................... 215
11.2.12 pH-sensor calibration, FM 13 ................................................................................ 217
11.2.12.1 Equipment needed ............................................................................................ 217
11.2.12.2 Calibration steps................................................................................................ 217
11.2.12.3 Offset calibration................................................................................................ 217
11.2.12.4 Complete calibration.......................................................................................... 218
11.2.13 Blood Leakage Detector calibration, FM 24 .......................................................... 219
11.2.14 Internal pressure regulator calibration (AK 200 ULTRA S dialysis machine
only)................................................................................................................... 220
11.2.15 Inlet pressure regulator adjustment ....................................................................... 221
11.2.16 Conductivity Transducer calibration, FM 20 - with liquid concentrate ................... 222
11.2.17 Conductivity Transducer calibration, FM 20 - with SelectCart cartridge ................ 223
11.2.18 BiCart Select - Level detector calibration............................................................. 225
11.2.18.1 Equipment needed ............................................................................................ 225
11.2.18.2 General.............................................................................................................. 225
11.2.18.3 Calibration instruction ........................................................................................ 226
11.2.18.4 Trouble shooting ................................................................................................ 227
11.2.19 BiCart Select - control and protective pump calibration ....................................... 227
11.2.19.1 Equipment needed ............................................................................................ 227
11.2.19.2 General.............................................................................................................. 227
11.2.19.3 Preparations ...................................................................................................... 228
11.2.19.4 Calibration instruction ........................................................................................ 229
11.2.19.5 Verification ......................................................................................................... 230
11.2.20 Calibration of Flow Restrictor Node (FRN) main flow supervision......................... 230
11.2.20.1 General.............................................................................................................. 230
11.2.20.2 Calibration instruction, with liquid concentrate .................................................. 231
11.2.20.3 Calibration instruction, with SelectCart cartridge............................................... 232
11.2.20.4 Trouble shooting ................................................................................................ 232
11.2.21 Automatic UF calibration/Supervision flowmeter calibration.................................. 233
11.2.21.1 Equipment needed ............................................................................................ 233
11.2.21.2 General.............................................................................................................. 233
11.2.21.3 Running the UF calibration, with liquid concentrate .......................................... 234
11.2.21.4 Running the UF calibration, with SelectCart cartridge....................................... 234
11.2.21.5 Verification of the UF cell calibration ................................................................. 235

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11.3 Calibration, Blood Monitor ....................................................................................... 236
11.3.1 A/D Converter BM(CPU P), BM 4.......................................................................... 236
11.3.2 Venous Pressure Transducer calibration, BM 3 .................................................... 238
11.3.3 Arterial Pressure Transducer calibration, BM 2 ..................................................... 240
11.3.4 System Pressure Transducer calibration, BM 1 .................................................... 242
11.3.5 Level Detector calibration (Air detector), BM 5...................................................... 243
11.3.6 Trouble shooting .................................................................................................... 244
11.3.7 Priming Detector calibration, BM 6 ........................................................................ 245
11.3.8 Blood Volume Sensor - BVS.................................................................................. 245
11.3.9 Temperature BM CPU Board calibration, BM 0 ..................................................... 245
11.3.10 Occlusion adjustment, blood pump/substitution flow pump................................... 246
11.3.11 BPM test ................................................................................................................ 247
11.3.11.1 Equipment needed ............................................................................................ 247
11.3.11.2 Test method ....................................................................................................... 247
11.3.11.3 BPM sub-test ..................................................................................................... 248
11.3.11.4 Check of air leakage.......................................................................................... 248
11.3.11.5 Check of inflation speed .................................................................................... 249
11.3.11.6 Check of pressure transducer calibration and measured pressure ................... 249

11.4 Logging after calibration .......................................................................................... 249


11.4.1 GXL-logging........................................................................................................... 249
11.4.2 Procedure .............................................................................................................. 250
11.4.3 Logging values ...................................................................................................... 250

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11.1 General

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Guidelines for the AK 200 S / AK 200 ULTRA S dialysis machine, related to Service
and Maintenance:
During transportation and storage: AK 200 S / AK 200 ULTRA S dialysis machine
must for practical reasons be rinsed and drained, however, as soon as the
machine is installed, the disinfection schedule should be followed.
During repair of any of the parts in the flow path, special care should be taken and
a good hygiene should be kept.
Used and repaired spare parts may be used in the AK 200 S / AK 200 ULTRA S
dialysis machine if they are cleaned and repaired in a good way.
A general guide line is that the ultrafilters should be mounted on the
AK 200 S / AK 200 ULTRA S dialysis machine as well as the disinfection schedule
should be followed, as soon as the machine is connected to the water supply.

WARNING!
After completing the check and calibrations, the conductivity value must always be
confirmed by the hospital laboratory or equivalent.

Before calibration
Perform:
1. A decalcification to remove calcium precipitates.
2. A disinfection to remove organic residuals.
For details, refer to the AK 200 S / AK 200 ULTRA S Operators Manual. This is not
necessary if this has been done during maintenance.

11.2 Calibration, Fluid Monitor

11.2.1 Technical Facilities


The following instructions are based on the availability of some technical facilities,
listed below.

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Test equipment: Tolerance: Manufacturer: Gambro Order
number:
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Conductivity 0.1 mS/cm MESA, IBP


measurement
Pressure measurement 2 mmHg within 200 mmHg MESA, IBP, Druck
1% beyond 200 mmHg
If BPM is installed:
0.8 mmHg
UF calibration station Gambro K21908002
Temperature 0.2 C MESA, IBP
measurement:
Digital Voltmeter 0.5% Fluke
Measuring glass 5 ml Any
Blood leakage Calibration N/A Gambro K40169001
Cover
Gauge pin kit for blood T = 1.1 (Stop pin = 1.1 x 2 x 0.7 = 1.5 mm) Gambro K40158001
pump rollers (including T = 1.6 (Stop pin = 1.6 x 2 x 0.7 = 2.2 mm)
three different pins)
T = 2.0 (Stop pin = 2.0 x 2 x 0.7 = 2.8 mm)
T = wall thickness of the blood tubing
Gauge pin kit for blood T = 1.1 (Stop pin = 1.1 x 2 x 0.7 = 1.5 mm) Gambro K40158002
pump rollers (to be T = 1.6 (Stop pin = 1.6 x 2 x 0.7 = 2.2 mm) K40158003
ordered separately)
T = 2.0 (Stop pin = 2.0 x 2 x 0.7 = 2.8 mm) K40158004
T = wall thickness of the blood tubing
Calibration tube kit N/A Gambro K13983002
Drip chamber N/A Gambro N/A
Tube for calibration of N/A Gambro N/A
priming detector
Safety tester According to IEC 60601-1 Rigel, Biotec,
Metron, Fluke
BPM test equipment (if N/A Gambro K22151001
installed)
BPM Cuff (if installed) N/A Gambro 110350
pH buffers (if installed) 0.07 pH units Any pH 7
100810001
pH 9
100810002
BVS test tool N/A Gambro K22281001
Magnet for blood pump N/A Gambro K19049002
cover
Measuring cylinder N/A Gambro K22349001
Leakage current access Gambro K40246001
point, PLT box

11.2.2 A/D Converter FM (CPU Q), FM 21


Equipment needed
Digital voltmeter
Procedure
1) Start the AK 200 S / AK 200 ULTRA S dialysis machine and enter the service
menu, Calibr / FM / Extern.

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2) Set the display to:

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3) Press the Start UF Stop button to enter calibration routine.
4) Measure the voltage between TP 3 (earth) and TP 1 (ref) on the FM CPU board.
(See figure below.)

5) Set the REF SET on the display to the value shown on the voltmeter (min. 48.96
mV max. 50.88 mV). Press the Arrow button to confirm.
6) Press the Start UF Stop button to load the value into the EEPROM.

11.2.3 A/D Converter FM (CPU F;1), FM 22


Equipment needed
Digital voltmeter
Procedure
1) Start the AK 200 S / AK 200 ULTRA S dialysis machine and enter the service
menu, Calibr / FM / Extern.
2) Set the display to:

3) Press the Start UF Stop button to enter calibration routine.

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4) Measure the voltage between TP 10 (earth) and TP 8 (ref) on the FM CPU board.
(See figure below.)
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5) Set the REF SET on the display to the value shown on the voltmeter (min. 48.96
mV max. 50.88 mV). Press the Arrow button to confirm.
6) Press the Start UF Stop button to load the value into the EEPROM.

11.2.4 A/D Converter FM (CPU F;2), FM 23


Equipment needed
Digital voltmeter
Procedure
1) Start the AK 200 S / AK 200 ULTRA S dialysis machine and enter the service
menu, Calibr / FM / Extern.
2) Set the display to:

3) Press the Start UF Stop button to enter calibration routine.

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4) Measure the voltage between TP 5 (earth) and TP 2 (ref) on the FM CPU board.
(See figure below)

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5) Set the REF SET on the display to the value shown on the voltmeter (min. 48.96
mV max. 50.88 mV). Press the Arrow button to confirm.
6) Press the Start UF Stop button to load the value into the EEPROM.

11.2.5 Temperature FM CPU Board calibration, FM 0


Equipment needed
Temperature meter
Procedure
1) Remove the rear cover of the FM.
2) Make sure AK 200 S / AK 200 ULTRA S dialysis machine has been switched off
for at least 30 min. without being moved (to assure room temperature on the FM
CPU board). Also make sure the reference instrument transducer has been in
room temperature at least 30 minutes.
3) Start the AK 200 S / AK 200 ULTRA S dialysis machine, enter the service menu,
Calibr / FM / Extern and set the display to:

4) Press the Start UF Stop button to enter calibration routine.


5) Read the room temperature on a Temperature meter and set the REF SET value
on the AK 200 S / AK 200 ULTRA S dialysis machine display to the same value.
6) Press the lit Arrow button below REF SET to enter the value and wait for the
calibration display.
7) Press the Start UF Stop button to load the value into the EEPROM.

NOTE!
Calibrations of temperature transducers in heating vessel or conductivity cell
need special equipment and can only be performed at Gambro Lundia AB, Lund.

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11.2.6 Degassing Transducer calibration, FM 7
(Tolerance 5 mmHg or 3%)
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Equipment needed
Pressure reference instrument, Calibration tube set.
Procedure
1) Start the AK 200 S / AK 200 ULTRA S dialysis machine and let it run with fluid for
15 minutes.
2) Initiate drain. When the Rinse/Drain button starts to flash, enter the service menu,
Calibr / FM / Extern.
3) Set the display to:

4) Press the Start UF Stop button to enter the calibration routine.


5) Disconnect the degassing pressure transducer from the degassing pump.
Connect a straight silicone connector and insert a plug (from the calibration kit)
according to the figure below (1).
6) Connect Gambro reference instrument to the silicone connector according to the
figure below (2).

7) Apply zero pressure by opening the three clamps A, B and C on the calibration
tube set.
8) Set the REF SET value on the display to 0 mmHg (with the Set knob).
9) Press the Arrow button below REF SET to enter the value and wait for the
calibration display.

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10) Close clamp A. Apply a pressure of approx. -500 mmHg, shown on the reference
instrument. Close clamp B.

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11) Set the REF SET value on the AK 200 S / AK 200 ULTRA S dialysis machine
display to the same value as shown on the reference instrument.
12) Press the Arrow button below REF SET to enter the value and wait for the
calibration display.
13) The machine will now ask you to confirm to enter sensitivity calibration. To
confirm: press the Arrow button below Yes.
14) Open clamp A and B, then close clamp A again. Apply a pressure of approx. +500
mmHg, shown on the reference instrument. Close clamp B.
15) Set the REF SET value on the AK 200 S / AK 200 ULTRA S dialysis machine
display to the same value as shown on the reference instrument.
16) Press the Arrow button below REF SET to enter the value and wait for the
calibration display.
17) Press the Start UF Stop button to load the value into the EEPROM.
18) Reconnect the fluid path to its original design after the calibration.
19) To exit from the Calibration routine, press the Hold button.
20) Always perform a Heat disinfection after the fluid path has been opened.

NOTE!
*If an error message is shown on the display at this point, press the Hold button
and start again from step 4. If the error still exists after a second try, check that
the calibration tubes are intact. If the tubes are correct, repeat the calibration
procedure with a new transducer. Ex. of calibration error message:

11.2.7 Flow Output Pressure Transducer calibration, FM 8


(Tolerance 5 mmHg or 3%)
Equipment needed
Pressure reference instrument, Calibration tube set.
Procedure
1) Start the AK 200 S / AK 200 ULTRA S dialysis machine and let it run with fluid for
15 minutes.
2) Initiate drain. When the Rinse/Drain button starts to flash, enter the service menu,
Calibr / FM / Extern.
3) Set the display to:

4) Press the Start UF Stop button to enter the calibration routine.

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5) Disconnect the flow output pressure transducer from the flow output pump.
Connect a straight silicone connector and insert a plug (from the calibration kit)
11 Calibration manual

according to the figure below (1).


6) Connect Gambro reference instrument to the silicone connector according to the
figure below (2).

7) Apply zero pressure by opening the three clamps A, B and C on the calibration
tube set.
8) Set the REF SET value on the display to 0 mmHg (with the Set knob).
9) Press the Arrow button below REF SET to enter the value and wait for the
calibration display.
10) Close clamp A. Apply a pressure of approx. -500 mmHg, shown on the reference
instrument. Close clamp B.
11) Set the REF SET value on the AK 200 S / AK 200 ULTRA S dialysis machine
display to the same value as shown on the reference instrument.
12) Press the Arrow button below REF SET to enter the value and wait for the
calibration display.
13) The machine will now ask you to confirm to enter sensitivity calibration. To
confirm: press the Arrow button below Yes.
14) Open clamp A and B, then close clamp A again. Apply a pressure of approx. +500
mmHg, shown on the reference instrument. Close clamp B.
15) Set the REF SET value on the AK 200 S / AK 200 ULTRA S dialysis machine
display to the same value as shown on the reference instrument.
16) Press the Arrow button below REF SET to enter the value and wait for the
calibration display.
17) Press the Start UF Stop button to load the value into the EEPROM.
18) Reconnect the fluid path to its original design after the calibration.

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19) To exit from the Calibration routine, press the Hold button.

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20) Always perform a Heat disinfection after the fluid path has been opened.

NOTE!
*If an error message is shown on the display at this point, press the Hold button
and start again from step 4. If the error still exists after a second try, check that
the calibration tubes are intact. If the tubes are correct, repeat the calibration
procedure with a new transducer. Ex. of calibration error message:

11.2.8 Flow Input Pressure Transducer calibration, FM 9


(Tolerance 5 mmHg or 3%)
Equipment needed
Pressure reference instrument, Calibration tube set.
Procedure
1) Start the AK 200 S / AK 200 ULTRA S dialysis machine and let it run with fluid for
15 minutes.
2) Initiate drain. When the Rinse/Drain button starts to flash, enter the service menu,
Calibr / FM / Extern.
3) Set the display to:

4) Disconnect tube no. 32 at the EVVA valve and block tube no. 32 by using a closed
tube.
5) Disconnect both end of tube no. K23473 at the pressure transducer unit.
6) Press the Start UF Stop button to enter calibration routine.
7) Set the REF SET value on the display to 0 mmHg (with the Set knob).
8) Press the lit Arrow button below REF SET to enter the value and wait for the
calibration display.
9) Connect a Pressure reference instrument (together with a calibration tube) in the
place of tube no. K23473 at the side of the pressure transducer unit that is
connected to the flow input pump unit.
10) Apply zero pressure by opening the three clamps A, B and C on the calibration
tube set.
11) Close clamp A. Apply a pressure of approx. +500 mmHg, shown on the reference
instrument. Close clamp B.
12) Set the REF SET value on the AK 200 S / AK 200 ULTRA S dialysis machine
display to the same value as shown on the Pressure reference instrument.
13) Press the lit Arrow button below REF SET to enter the value and wait for the
calibration display.

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14) The machine will now ask you to confirm to enter sensitivity calibration. To
confirm: press the Arrow button below Yes.
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15) Press the Start UF Stop button to load the value into the EEPROM.
16) Reconnect the fluid path to its original design after the calibration.
17) Always perform a Heat disinfection after the fluid path has been opened.

11.2.9 High Pressure Guard Transducer calibration, FM 10


(Tolerance 5 mmHg or 3%)
Equipment needed
Pressure reference instrument, Calibration tube set.
Procedure
1) Start the AK 200 S / AK 200 ULTRA S dialysis machine and let it run with fluid for
15 minutes.
2) Initiate drain. When the Rinse/Drain button starts to flash, enter the service menu,
Calibr / FM / Extern.
3) Set the display to:

4) Disconnect tube no. 19 at the bypass unit.


5) Connect Gambro reference instrument according to the figure below.
6) Apply zero pressure by opening the three clamps A, B and C on the calibration
tube set.
7) Set the REF SET value on the display to 0 mmHg (with the Set knob).
8) Press the Arrow button below REF SET to enter the value and wait for the
calibration display.
9) Close clamp A. Apply a pressure of approx. -500 mmHg, shown on the reference
instrument. Close clamp B.

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10) Set the REF SET value on the AK 200 S / AK 200 ULTRA S dialysis machine
display to the same value as shown on the reference instrument.

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11) Press the Arrow button below REF SET to enter the value and wait for the
calibration display.
12) The machine will now ask you to confirm to enter sensitivity calibration. To
confirm: press the Arrow button below Yes.
13) Open clamp A and B, then close clamp A again. Apply a pressure of approx. +500
mmHg, shown on the reference instrument. Close clamp B.
14) Set the REF SET value on the AK 200 S / AK 200 ULTRA S dialysis machine
display to the same value as shown on the reference instrument.
15) Press the Arrow button below REF SET to enter the value and wait for the
calibration display.
16) Press the Start UF Stop button to load the value into the EEPROM.
17) Reconnect the fluid path to its original design after the calibration.
18) To exit from the Calibration routine, press the Hold button.
19) Always perform a Heat disinfection after the fluid path has been opened.

NOTE!
*If an error message is shown on the display at this point, press the Hold button
and start again from step 5. If the error still exists after a second try, check that
the calibration tubes are intact. If the tubes are correct, repeat the calibration
procedure with a new transducer. Ex. of calibration error message:

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11.2.10 Dialysis Fluid Pressure Transducer (PD) calibration, FM 11
(Tolerance 5 mmHg or 3%)
11 Calibration manual

Equipment needed
Pressure reference instrument, Calibration tube set.
Procedure
1) Start the AK 200 S / AK 200 ULTRA S dialysis machine and let it run with fluid for
15 minutes.
2) Initiate drain. When the Rinse/Drain button starts to flash, enter the service menu,
Calibr / FM / Extern.
3) Set the display to:

4) Press the Start UF Stop button to enter the calibration routine.


5) Disconnect the carbon tube connector located on the inside of the dialysis fluid
inlet (from the dialyzer).

NOTE!
Be careful - the carbon tube can easily be damaged. Pull the silicon connector
straight up.

6) Connect Gambro reference instrument to the carbon tube connector according to


the figure below.

7) Apply zero pressure by opening the three clamps A, B and C on the calibration
tube set.
8) Set the REF SET value on the display to 0 mmHg (with the Set knob).
9) Press the Arrow button below REF SET to enter the value and wait for the
calibration display.
10) Close clamp A. Apply a pressure of approx. -500 mmHg, shown on the reference
instrument. Close clamp B.
11) Set the REF SET value on the AK 200 S / AK 200 ULTRA S dialysis machine
display to the same value as shown on the reference instrument.

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12) Press the Arrow button below REF SET to enter the value and wait for the
calibration display.

11 Calibration manual
13) The machine will now ask you to confirm to enter sensitivity calibration. To
confirm: press the Arrow button below Yes.
14) Open clamp A and B, then close clamp A again. Apply a pressure of approx. +500
mmHg, shown on the reference instrument. Close clamp B.
15) Set the REF SET value on the AK 200 S / AK 200 ULTRA S dialysis machine
display to the same value as shown on the reference instrument.
16) Press the Arrow button below REF SET to enter the value and wait for the
calibration display.
17) Press the Start UF Stop button to load the value into the EEPROM.
18) Reconnect the fluid path to its original design after the calibration.
19) To exit from the Calibration routine, press the Hold button.
20) Always perform a Heat disinfection after the fluid path has been opened.

NOTE!
*If an error message is shown on the display at this point, press the Hold button
and start again from step 4. If the error still exists after a second try, check that
the calibration tubes are intact. If the tubes are correct, repeat the calibration
procedure with a new transducer. Ex. of calibration error message:

11.2.11 Safety Guard Pressure Transducer calibration, FM 12


(Tolerance 5 mmHg or 3%)
Equipment needed
Pressure reference instrument, Calibration tube set.
Procedure
1) Start the AK 200 S / AK 200 ULTRA S dialysis machine and let it run with fluid for
15 minutes.
2) Initiate drain. When the Rinse/Drain button starts to flash, enter the service menu,
Calibr / FM / Extern.
3) Set the display to:

4) Press the Start UF Stop button to enter calibration routine.


5) Disconnect the safety guard pressure transducer. Connect a straight silicone
connector and insert a plug (from the calibration kit) according to the figure below
(1).

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6) Connect Gambro reference instrument to the silicone connector according to the
figure below (2).
11 Calibration manual

7) Apply zero pressure by opening the three clamps A, B and C on the calibration
tube set.
8) Set the REF SET value on the display to 0 mmHg (with the Set knob).
9) Press the Arrow button below REF SET to enter the value and wait for the
calibration display.
10) Close clamp A. Apply a pressure of approx. -500 mmHg, shown on the reference
instrument. Close clamp B.
11) Set the REF SET value on the AK 200 S / AK 200 ULTRA S dialysis machine
display to the same value as shown on the reference instrument.
12) Press the Arrow button below REF SET to enter the value and wait for the
calibration display.
13) The machine will now ask you to confirm to enter sensitivity calibration. To
confirm: press the Arrow button below Yes.
14) Open clamp A and B, then close clamp A again. Apply a pressure of approx. +500
mmHg, shown on the reference instrument. Close clamp B.
15) Set the REF SET value on the AK 200 S / AK 200 ULTRA S dialysis machine
display to the same value as shown on the reference instrument.
16) Press the Arrow button below REF SET to enter the value and wait for the
calibration display.
17) Press the Start UF Stop button to load the value into the EEPROM.
18) Reconnect the fluid path to its original design after the calibration.
19) To exit from the Calibration routine, press the Hold button.
20) Always perform a Heat disinfection after the fluid path has been opened.

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NOTE!
*If an error message is shown on the display at this point, press the Hold button

11 Calibration manual
and start again from step 4. If the error still exists after a second try, check that
the calibration tubes are intact. If the tubes are correct, repeat the calibration
procedure with a new transducer. Ex. of calibration error message:

11.2.12 pH-sensor calibration, FM 13

11.2.12.1 Equipment needed


Bowl with pH 7 buffer solution and bowl with pH 9 buffer solution.

11.2.12.2 Calibration steps


Calibration should be performed on a regular basis to ensure optimum performance.
A complete calibration procedure consists of the following steps:
Offset calibration, with a buffer solution (a solution with a very accurate and
stable pH-value) having a pH-value in the range of pH 6.5-7.5, followed by;
Slope calibration, with a buffer solution having pH-value that differs at least 2
pH-units from the buffer used for offset calibration.

Calibration schedule
An Offset calibration should be performed after one month in operation and then
every third month to verify the performance.
A Complete calibration procedure should be performed at installation and then every
12 months.

11.2.12.3 Offset calibration


Procedure
1) Initiate drain.
2) When the Rinse/Drain button starts to flash, enter the service menu and set
theAK 200 S / AK 200 ULTRA Sdialysis machine display to:

3) Press the Start UF Stop button to enter calibration routine.


4) Remove the pH sensor from the pH sensor housing by loosening the nut holding
the pH sensor and rinse the sensor in RO water.
5) Set REF SET on theAK 200 S / AK 200 ULTRA Sdialysis machine display to pH
7.
6) Put the pH sensor in a bowl with pH 7 buffer solution which must cover the glass
membrane i.e. the solution should reach at least 30 mm above the bottom of the
bowl.

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7) Stir in order to achieve balance in the buffer solution. Do not let the pH sensor
lean against the bottom of the bowl. Wait for 2 minutes.
11 Calibration manual

8) Press the Arrow button below REF SET and wait until the calibration display
returns.

NOTE!
If an error message is shown on the display at this point, check the buffer
solutions, the level in the bowl and repeat the procedure from step 1. If the error
still exists after a second try, replace the pH sensor.

9) Press the Start UF Stop button to load the value into the EEPROM.
10) Remount the pH sensor into the pH sensor housing.

11.2.12.4 Complete calibration


Procedure
1) Initiate drain.
2) When the Rinse/Drain button starts to flash, enter the service menu and set
theAK 200 S / AK 200 ULTRA Sdialysis machine display to:

3) Press the Start UF Stop button to enter calibration routine.


4) Remove the pH sensor from the pH sensor housing by loosening the nut holding
the pH sensor and rinse the sensor in RO water.
5) Set REF SET on theAK 200 S / AK 200 ULTRA Sdialysis machine display to pH
7.
6) Put the pH sensor in a bowl with pH 7 buffer solution which must cover the glass
membrane i.e. the solution should reach at least 30 mm above the bottom of the
bowl.
7) Stir in order to achieve balance in the buffer solution. Do not let the pH sensor
lean against the bottom of the bowl. Wait for 2 minutes.
8) Press the Arrow button below REF SET and wait until the calibration display
returns.

NOTE!
If an error message is shown on the display at this point, check the buffer
solutions, the level in the bowl and repeat the procedure from step 1. If the error
still exists after a second try, replace the pH sensor.

9) Rinse the pH sensor in RO water.


10) Set REF SET on theAK 200 S / AK 200 ULTRA Sdialysis machine display to pH
9.
11) Put the pH sensor in a bowl with pH 9 buffer solution which must cover the glass
membrane i.e. the solution should reach at least 30 mm above the bottom of the
bowl.
12) Stir in order to achieve balance in the buffer solution. Do not let the pH sensor
lean against the bottom of the bowl. Wait for 2 minutes.

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13) Press the Arrow button below REF SET and wait. The display shows: Entering
sensitivity calibration

11 Calibration manual
14) Press the Arrow button below Yes to confirm that the calibration continues.
15) When the calibration display returns, press the Start UF Stop button to load the
value into the EEPROM.
16) Remount the pH sensor into the pH sensor housing.

NOTE!
The pH sensor should be changed every eighteenth month.

11.2.13 Blood Leakage Detector calibration, FM 24


Equipment needed
Blood leakage calibration cover
Procedure
1) Initiate drain.
2) Remove the blood leakage detector cover and clean the inside of the blood
leakage detector housing.
3) Mount a blood leakage calibration cover (K40169001). Make sure that the filter is
in horizontal position.
4) Enter the Service menu.
5) In service mode, select calibration, FM, intern and Blood Leakage Detector (FM
24).
6) Let the machine stabilize for 15 minutes. No concentrate shall be used.
7) Press the Start UF Stop button to enter the blood leakage calibration routine.
8) Set REF SET on the AK 200 S / AK 200 ULTRA S dialysis machine to zero.
9) Press the Arrow button below REF SET. *
10) Turn the calibration filter to vertical position.
11) Set REF SET on the Blood Monitor display to 100.
12) Press the Arrow button below REF SET.

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13) Confirm to enter sensivity calibration by pressing the Arrow button below YES. *
11 Calibration manual

14) Press the Start UF Stop button to store the calibration values.
15) Drain the AK 200 S / AK 200 ULTRA S dialysis machine and remount the standard
blood leakage cover.

NOTE!
*If an error message occurs during calibration: Check the position of the
calibration filter and repeat from point 1. If an error occurs after a 2nd try, change
the blood leakage detector.

11.2.14 Internal pressure regulator calibration (AK 200 ULTRA S dialysis


machine only)
Equipment needed
Pressure reference instrument, Calibration tube set.
Procedure
1) Let the machine pass the functional check.
2) Press the Fluid flow button and set the main flow to 500 ml/min.
3) Activate HDF or HF.
4) Press the Pressure control button for 3 seconds until lit.
5) Connect the dialyzer coupling to the conductivity cell on the pressure reference
instrument.
6) Adjust venous pressure to +100 mmHg. Check that TMP is approximately +150
mmHg.
7) Connect a tube between the substitution fluid port and the external pressure
reference instrument.
8) Press the Fluid bypass button to obtain main flow through the pressure regulator.
9) Adjust the pressure regulator to +55 mmHg 5 mmHg. To get a correct reading,
the reference instrument and the test tube must be at same height as the
substitution fluid port.

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10) Press the Fluid bypass button and remove the pressure reference instrument
and tube.

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11.2.15 Inlet pressure regulator adjustment
Equipment needed
T-connector, short PEX tube, Pressure reference instrument, Calibration tube set.
Procedure
1) Turn off the water supply.
2) Disconnect the inlet water tube at the test point (just before the non-return valve)
according to following illustration.

3) Insert a T-connector and a short PEX tube just before the non-return valve. To
prevent water from entering the disk filter/reference instrument, insert an extra
volume of approx.100 ml between the T-connector and the calibration tube set.

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(Use for instance a silicon tube, 100312032, with a length of 1.2 m as the extra
volume). Connect the reference instrument to the calibration tube set.
11 Calibration manual

Important! Use a disc filter, according to the figure above, to protect the reference
instrument.
4) Close clamp C.
5) Turn on the water supply.
6) Start theAK 200 S / AK 200 ULTRA Sdialysis machine. Perform a functional
check and wait until the conductivity and the temperature are stable. The fluid
path on the OP-panel must be green before the calibration begins.
7) Zeroset the Reference instrument, wait for stable reading.
8) Close clamp A and B. Open clamp C.
9) Adjust the inlet pressure regulator until the pressure measured at the reference
instrument is 900 mmHg (1.2 bar or 120 kPa).
10) Perform a Drain.
11) Turn off the water supply. Reconnect the fluid path to its original design after the
calibration.
12) Always perform a Heat disinfection after the fluid path has been opened.

11.2.16 Conductivity Transducer calibration, FM 20 - with liquid


concentrate
Equipment needed
Reference instrument
The calibration is a two point calibration. The two points are 0 mS/cm (RO-water) and
14 mS/cm (with concentrate).

NOTE!
Before conductivity calibration, Chemical cleaning must be performed, one with
Citric acid and one with Hypochlorite.
Check the temperature transducers since the temperature affects the
conductivity calculations.
To keep the temperature inside theAK 200 S / AK 200 ULTRA Sdialysis
machine, do not remove the blood monitor and make sure the plastic shield
covers the interior of the fluid monitor.
The main flow must be set to 500 ml/min.
FM 20 is the complete calibration for all conductivity transducers and is
recommended by Gambro. It is possible to select between several different
conductivity calibrations, to fit all needs. All these calibrations are done in the
same way as described below. Refer to Service Technician's Guide / Fluid
monitor flow diagram, calibration.
Procedure
1) Start theAK 200 S / AK 200 ULTRA Sdialysis machine.
2) Enter the service menu, Calibr / FM / Intern.

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3) Set the display to:

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4) Press the Start UF Stop button to enter calibration routine.
5) Place both the A and B pick-up tubes into the heating vessel. Connect the
reference instrument according to the figure below.

6) Press the Fluid bypass button if lit. Let theAK 200 S / AK 200 ULTRA Sdialysis
machine and the reference instrument stabilise at 0 mS/cm and 37C for at least
15 minutes.
7) Set the REF SET value on the display to the same value as shown on the
reference instrument with the Set knob .
8) Press the lit Arrow button below REF SET to enter value and wait for next display.
9) Put the A pick-up tube into the concentrate container and let
theAK 200 S / AK 200 ULTRA Sdialysis machine stabilize at 14 mS/cm and 37C
for 15 minutes.
10) Set the REF SET value on the display to the same value shown on the reference
instrument.
11) Press the lit Arrow button below REF SET to enter the value and wait for the
calibration display.
12) The machine will now ask you to confirm to enter sensitivity calibration.To confirm:
press the Arrow button below Yes.
13) Press the Start UF Stop button to load the value into the EEPROM.

11.2.17 Conductivity Transducer calibration, FM 20 - with SelectCart


cartridge
Equipment needed
Reference instrument
The calibration is a two point calibration. The two points are 0 mS/cm (RO-water) and
14 mS/cm (with concentrate).

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NOTE!
Before conductivity calibration, Chemical cleaning must be performed, one with
11 Calibration manual

Citric acid and one with Hypochlorite.


Check the temperature transducers since the temperature affects the
conductivity calculations.
To keep the temperature inside theAK 200 S / AK 200 ULTRA Sdialysis
machine, do not remove the blood monitor and make sure the plastic shield
covers the interior of the fluid monitor.
The main flow must be set to 500 ml/min.
FM 20 is the complete calibration for all conductivity transducers and is
recommended by Gambro. It is possible to select between several different
conductivity calibrations, to fit all needs. All these calibrations are done in the
same way as described below. Refer to Service Technician's Guide / Fluid
monitor flow diagram, calibration.
Procedure
1) Start theAK 200 S / AK 200 ULTRA Sdialysis machine.
2) Enter the service menu, Calibr / FM / Intern.
3) Set the display to:

NOTE!
Error code FCN 5.11 001 may be issued during the calibration. This can be
ignored.

4) Press the Start UF Stop button to enter calibration routine.


5) Close all latches and place both the A and B pick-up tubes in the heating vessel.
6) Connect the reference instrument according to the figure below.

7) Press the Fluid bypass button if lit.


8) Let theAK 200 S / AK 200 ULTRA Sdialysis machine stabilize at 0 mS/cm and
37C for at least 15 minutes.

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9) Set the REF SET value on the display to the same value shown on the reference
instrument.

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10) Press the lit Arrow button below REF SET to enter value and wait for next display.
11) Attach a SelectCart cartridge.
12) Let theAK 200 S / AK 200 ULTRA Sdialysis machine stabilize at 14 mS/cm and
37C for 15 minutes.
13) Set the REF SET value to the same value shown on the reference instrument.
14) Press the lit Arrow button below REF SET to enter the value and wait for the
calibration display.
15) The machine will now ask you to confirm to enter sensitivity calibration.To confirm:
press the Arrow button below Yes.
16) Press the Start UF Stop button to load the value into the EEPROM.

11.2.18 BiCart Select - Level detector calibration

11.2.18.1 Equipment needed


SelectBag container (filled)

11.2.18.2 General
The level detector is used in the protective system for supervision of the SelectBag
concentrate flow.
It consists of an IR-LED and an IR-transistor placed on a fluid chamber. The goal is to
form a logical output if the chamber is filled with liquid or not. The sensitivity is
dependent on the modulation frequency that controls the IR-LED. This must be
calibrated by adjusting the fluid level and finding the correct frequency.
The calibration is performed automatically in theAK 200 S / AK 200 ULTRA Sdialysis
machine calibration routine and requires only a filled SelectBag container.

NOTE!
The machine should be run with fluid for approximately 15 minutes followed by a
Rinse/Drain before the calibration is performed.
When the level detector is calibrated with default value (i.e. the first time), this
value might cause the pump not to stop at full chamber since high level is not
detected. This will mean that fluid is pumped out through the disinfection port in
the SelectCart cartridge holder (lower port) during the priming phase.
To prevent that air is getting trapped inside the particle filter after the SelectBag
container holder (50 m), it is important that the particle filter is correct
positioned according to following illustration.

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11.2.18.3 Calibration instruction
Procedure
11 Calibration manual

1) Enter the AK 200 S / AK 200 ULTRA S dialysis machine service menu


Calibr/FM/Other/Lvl det.
2) Attach a SelectBag container to the SelectBag container holder.

WARNING!
Avoid touching the plastic spike.

WARNING!
Be careful to avoid fluid from the SelectBag container splashing into your eyes.

a) Open the cap on the SelectBag container.


b) Open and hold the latch of the SelectBag container holder in its uppermost
position while hanging the SelectBag container into the holder with the
connector port upwards.
c) Press down the latch to a horizontal position, whereby the membrane of the
SelectBag container is punctured by the spike.
d) Tap lightly on the SelectBag container so that any air bubbles gather at the
top.

3) Open both SelectCart cartridge latches and press Start.


The calibration will now be performed automatically by the
AK 200 S / AK 200 ULTRA S dialysis machine. Two calibrations are performed
and their results are compared. If the difference are within a limit, the calibration is
approved.
When the calibration is ready, the following text is displayed:

4) Press the Start UF Stop button to load the value into the EEPROM.

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11.2.18.4 Trouble shooting
If the calibration was unsuccessful, the following attention is displayed:

11 Calibration manual
Possible reasons for problems are:
No SelectBag container inserted
Fluid tubes faulty connected/leaking
Pump volumes not calibrated
Defective level detector/misconnected
Air/foam is SelectBag fluid tubes and/or level detector chamber
Calibration values differ too much
Pumps defective or faulty connected
Defective FM CPU board
If no obvious errors are found, perform a new calibration.
If the calibration value storage was unsuccessful, the following attention is displayed:

Possible reasons for problems are:


Defective FM CPU board
Faulty cable connections
Check and replace if problems remain.

11.2.19 BiCart Select - control and protective pump calibration

11.2.19.1 Equipment needed


SelectBag container, Measuring cylinder.

11.2.19.2 General
This calibration is intended to be done after following work operations:
Exchange of the control pump
Exchange of the protective pump
Exchange of the FM CPU board
Exchange of the select node PROM

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11.2.19.3 Preparations
Procedure
11 Calibration manual

1) To prevent that air is getting trapped inside the particle filter after the SelectBag
container holder (50 m), it is important that the particle filter is correct positioned
according to following illustration.

2) Prepare the fluid path for the calibration.


a) Disconnect the output tube from the BiCart Select control pump at the
Y-connector, according to the figure below pos. (1).
b) Re-connect the output tube to a silicone tube, 100312032 via connector
L05172001. Put this tube into an empty fluid container.
c) Clamp both tubes according to the figure below pos. (2).

3) Attach a SelectBag container to the SelectBag holder.

WARNING!
Avoid touching the plastic spike.

WARNING!
Be careful to avoid fluid from the SelectBag container splashing into your eyes.

a) Open the cap on the SelectBag container.


b) Open and hold the latch of the SelectBag holder in its uppermost position
while hanging the SelectBag container into the holder with the connector port
upwards.
c) Press down the latch to a horizontal position, whereby the membrane of the
SelectBag container is punctured by the spike.

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228 Calibration manual
d) Tap lightly on the SelectBag container so that any air bubbles gather at the
top.

11 Calibration manual
4) Open the lower latch of the SelectCart cartridge holder.

11.2.19.4 Calibration instruction


Procedure
1) Enter theAK 200 S / AK 200 ULTRA Sdialysis machine service menu, Calibr /
FM / Other / Sel pump
Following text is displayed:

2) To evacuate all air bubbles it is important to run following priming procedure


before starting the calibration.
Press the Arrow button below Priming. Let the machine flush fluid from the
SelectBag container, via the BiCart Select pumps to the empty fluid container. Tap
lightly on the SelectBag container to remove any air bubbles. Continue until there
are no air bubbles left after the control pump.
3) When the priming is completed (no air bubbles left), press the Arrow button below
Stop.
4) Move the silicone tube from the fluid container into the Measuring cylinder.
5) Press the Arrow button below Start to enter the calibration procedure.
6) The Measuring cylinder is filled up. When the pumps stop, enter the reference
volume from the Measuring cylinder in ml. Turning the Set knob sets the reference
volume.

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11 Calibration manual

The blue line on the Measuring cylinder indicates 250 ml. The Measuring cylinder
is graduated in 0.2 ml increments i.e. each small mark indicates 0.2 ml.
7) To enter the reference volume press the Arrow button below REF SET and the
calibration calculation starts.
8) When the result of the calculation is displayed, press the Start UF Stop button to
load the calibration values into the EEPROM.

11.2.19.5 Verification
Empty the Measuring cylinder. Insert a new SelectBag container to the holder. Repeat
step 6 to 10 according to the instruction above. Verify that the reference volume from
the Measuring cylinder is within 250 2 ml.

11.2.20 Calibration of Flow Restrictor Node (FRN) main flow supervision

11.2.20.1 General
The BiCart Select protective system uses a flow restrictor measurement for
supervision of the main flow and the UF volume. The main flow is used in the
supervision of the ratio between SelectBag concentrate- and main flow.
The Flow out restrictor and the Flow in restrictor are used to form restrictor flow
measuring devices. By using the Flow Out Pressure (FOP) the main flow is calculated.
By using the Flow Input Pressure (FIP) in combination with FOP the UF is calculated.

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NOTE!
Before the calibration procedure is started, perform a heat disinfection.

11 Calibration manual
If the machine is operated at high altitude, e.g. the preset S550 is used, the FCH
must pass state 18 (SP 004) before entering Service mode.
A UF-cell calibration will automatically be followed by FRN calibration.
If following parts (in the table below) are exchanged/calibrated, a new FRN
calibration must be performed and the following conditions must be fulfilled:
Stable temperature and conductivity
De air chamber level must be over 13 mm
Degassing level must be 50 mm
Exchanged Calibrated Installed
FOP transducer x x
FIP transducer x x
FOP pump x
FIP pump x
pH cell x x x
Cond. cell B x
FOP restrictor x
FIP restrictor x
UF cell x x
FM CPU board x

11.2.20.2 Calibration instruction, with liquid concentrate


Procedure
1) Enter theAK 200 S / AK 200 ULTRA Sdialysis machine service menu, Calibr /
FM / Other / UF.
2) Press the Arrow button below Restr.
3) Place the B pick-up tube in concentrate.
The calibration will now be performed automatically. CALIB NR 0-6 will be
displayed during calibration.

This attention message is displayed during verification.

This attention message is displayed when verification is done and passed. The
machine is ready for use.

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11.2.20.3 Calibration instruction, with SelectCart cartridge
Procedure
11 Calibration manual

1) Enter theAK 200 S / AK 200 ULTRA Sdialysis machine service menu, Calibr /
FM / Other / UF.
2) Press the Arrow button below Restr.
3) Attach a SelectCart cartridge.
The calibration will now be performed automatically. CALIB NR 0-6 will be
displayed during calibration.

This attention message is displayed during verification.

This attention message is displayed when verification is done and passed. The
machine is ready for use.

11.2.20.4 Trouble shooting


A FRN calibration takes approximately 20 minutes. If the calibration is not ready within
the double time, cancel and perform a new calibration.
Possible reasons for problems are:
Uncalibrated UF-cell
No concentrate
Leakage in fluid path
De air chamber level <13 mm
The following attention messages can be displayed for guidance.

The dialysis machine is not connected to water inlet.

Degassing chamber is not yet filled.

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De air chamber is not yet filled, the level is below 13 mm.

Required main flow is not achieved.

Fluid temperature is not correct.

Fluid conductivity is not correct.

Communication between CPUP and FRN fails.

Verification failed. The machine can not be used for treatment until a successful FRN
calibration has been performed.

11.2.21 Automatic UF calibration/Supervision flowmeter calibration

11.2.21.1 Equipment needed


UF calibration station

11.2.21.2 General
When automatic calibration is chosen, the Time lamp is lit. Complete automatic UF
calibration calibrates the UF cell and the supervision flow meter. The UF calibration
unit is used as reference in the calibration. (Refer to the UF calibration unit - User
Guide, HCEN9786.)

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Note that the verification of the UF cell calibration has to be done manually, refer to
Section 11.2.21.5 Verification of the UF cell calibration on page235.
11 Calibration manual

Prior to the calibration perform both a disinfection and a cleaning decalcification to


remove both organic and calcium precipitates, according to
theAK 200 S / AK 200 ULTRA SOperators Manual.
Prior to the calibration perform:
1. A decalcification to remove calcium precipitates.
2. A disinfection to remove organic residuals.
For details, refer to the AK 200 S / AK 200 ULTRA S Operators Manual.

11.2.21.3 Running the UF calibration, with liquid concentrate


Procedure
1) AK 200 ULTRA S dialysis machine only: Bypass the internal pressure regulator
when running the UF calibration.

NOTE!
All electrical connections must be done before the power is turned on to the
UF calibration box and theAK 200 S / AK 200 ULTRA Sdialysis machine. Be
aware of that there is no main switch on the UF calibration box.
Switch on the equipment in the following order:
a) Connect the UF calibration box to the mains.
b) Switch on the AK 200 S / AK 200 ULTRA S dialysis machine with the
main switch and then the ON/OFF button.

2) Use the UF calibration cable, to connect the UF calibration box, with


theAK 200 S / AK 200 ULTRA Sdialysis machine.
3) Connect the cable to the external connection port P 76 (blue coloured) at the rear
of theAK 200 S / AK 200 ULTRA Sdialysis machine.
4) Put the B suction tube to A concentrate container (or acetate container), A suction
tube in the heating vessel.
5) Enter service mode.
6) Connect the fluid tubes to the UF calibration box.
7) Select Service mode and then Calibr / FM / Other / UF / Auto /
Complete and set the reference volume.
What to do next
After the reference volume is confirmed the UF calibration runs automatically until the
calibration is finished. Nothing happens if the operator by mistake should press the
high limit key during automatic calibration.

NOTE!
Do not change to manual calibration while the box is filling or emptying!
When the automatic UF calibration/Supervision flow meter calibration is finished, a
verification has to be done.

11.2.21.4 Running the UF calibration, with SelectCart cartridge


Procedure
1) AK 200 ULTRA S dialysis machine only: Bypass the internal pressure regulator
when running the UF calibration.
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234 Calibration manual
NOTE!
All electrical connections must be done before the power is turned on to the

11 Calibration manual
UF calibration box and theAK 200 S / AK 200 ULTRA Sdialysis machine. Be
aware of that there is no main switch on the UF calibration box.
Switch on the equipment in the following order:
a) Connect the UF calibration box to the mains.
b) Switch on the AK 200 S / AK 200 ULTRA S dialysis machine with the
main switch and then the ON/OFF button.

2) Use the UF calibration cable, to connect the UF calibration box, with


theAK 200 S / AK 200 ULTRA Sdialysis machine.
3) Connect the cable to the external connection port P 76 (blue coloured) at the rear
of theAK 200 S / AK 200 ULTRA Sdialysis machine.
4) Attach a SelectCart cartridge.
5) Enter service mode.
6) Connect the fluid tubes to the UF calibration box.
7) Select Service mode and then Calibr / FM / Other / UF / Auto /
Complete and set the reference volume.
What to do next
After the reference volume is confirmed the UF calibration runs automatically until the
calibration is finished. Nothing happens if the operator by mistake should press the
high limit key during automatic calibration.

NOTE!
Do not change to manual calibration while the box is filling or emptying!
When the automatic UF calibration/Supervision flow meter calibration is finished, a
verification has to be done.

11.2.21.5 Verification of the UF cell calibration


Must be performed after automatic UF calibration/Supervision flow meter calibration is
performed.
Procedure
1) Restart theAK 200 S / AK 200 ULTRA Sdialysis machine and let it pass Fch.
2) Press the Fluid flow button and set the main flow rate to 400 ml/min.
3) Measure the drain flow during two minutes, use a graduated vessel with a volume
of approximately 1.5 l. Tap the drain flow during exactly two minutes, the
measured volume should be 800 ml 16 ml.
4) For accurate test, keep the hose at the same height during the entire test.
5) Set the Main flow to 600 ml/min and measure the drain flow as described above.
The measured volume should be 1200 ml 24 ml.
6) Rinse theAK 200 S / AK 200 ULTRA Sdialysis machine after the verification.

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Calibration manual 235
NOTE!
Switch off the equipment in the following order:
11 Calibration manual

1. Switch off theAK 200 S / AK 200 ULTRA Sdialysis machine with the ON/OFF
button and then the main switch.
2. Disconnect the UF calibration station (mains cable).

11.3 Calibration, Blood Monitor

11.3.1 A/D Converter BM(CPU P), BM 4


Equipment needed
Digital voltmeter
Procedure
1) Start theAK 200 S / AK 200 ULTRA Sdialysis machine and enter the service
menu, Calibr / BM.
2) Set the display to:

3) Press the Start UF Stop button to enter calibration routine.


4) Measure the voltage between TP 4 (earth) and TP 5 (ref) on the BM CPU board.
(See figure below)

5) Set the REF SET on the display to the value shown on the voltmeter (min. 48.96
mV max. 50.88 mV). Press the Arrow button to confirm.
6) Press the Start UF Stop button to load the value into the EEPROM.

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11.3.2 Venous Pressure Transducer calibration, BM 3
Equipment needed
11 Calibration manual

Pressure reference instrument, Calibration tube set.


Tolerance -700 to -500 mmHg 10%
-500 to +500 mmHg 5 mmHg or 3%
+500 to +750 mmHg 10%

Procedure
1) Start theAK 200 S / AK 200 ULTRA Sdialysis machine and enter the service
menu, Calibr / BM.
2) Set the display to:

3) Press the Start UF Stop button to enter calibration routine.


4) Connect Gambro reference instrument to the Venous Pressure Transducer
according to the figure.
5) Apply zero pressure by opening the three clamps A, B and C on the calibration
tube set.
6) Set the REF SET value on the display to 0 mmHg (with the Set knob ).
7) Press the Arrow button below REF SET to enter the value and wait for the
calibration display.
8) Close clamp A. Apply a pressure of approx. -500 mmHg, shown on the reference
instrument. Close clamp B.
9) Set the REF SET value on theAK 200 S / AK 200 ULTRA Sdialysis machine
display to the same value as shown on the reference instrument.
10) Press the Arrow button below REF SET to enter the value and wait for the
calibration display.
11) The machine will now ask you to confirm to enter sensitivity calibration.To confirm:
press the Arrow button below Yes.
12) Open clamp A and B, then close clamp A again. Apply a pressure of approx. +500
mmHg, shown on the reference instrument. Close clamp B.
13) Set the REF SET value on theAK 200 S / AK 200 ULTRA Sdialysis machine
display to the same value as shown on the reference instrument.
14) Press the Arrow button below REF SET to enter the value and wait for the
calibration display.
15) Press the Start UF Stop button to load the value into the EEPROM.

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16) To exit from the Calibration routine, press the Hold button.

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11.3.3 Arterial Pressure Transducer calibration, BM 2
Equipment needed
11 Calibration manual

Pressure reference instrument, Calibration tube set.


Tolerance -700 to -500 mmHg 10%
-500 to +500 mmHg 5 mmHg or 3%
+500 to +750 mmHg 10%

Procedure
1) Start theAK 200 S / AK 200 ULTRA Sdialysis machine and enter the service
menu, Calibr / BM.
2) Set the display to:

3) Press the Start UF Stop button to enter calibration routine.


4) Connect Gambro reference instrument to the Arterial Pressure Transducer
according to the figure.
5) Apply zero pressure by opening the three clamps A, B and C on the calibration
tube set.
6) Set the REF SET value on the display to 0 mmHg (with the Set knob ).
7) Press the Arrow button below REF SET to enter the value and wait for the
calibration display.
8) Close clamp A. Apply a pressure of approx. -500 mmHg, shown on the reference
instrument. Close clamp B.
9) Set the REF SET value on theAK 200 S / AK 200 ULTRA Sdialysis machine
display to the same value as shown on the reference instrument.
10) Press the Arrow button below REF SET to enter the value and wait for the
calibration display.
11) The machine will now ask you to confirm to enter sensitivity calibration.To confirm:
press the Arrow button below Yes.
12) Open clamp A and B, then close clamp A again. Apply a pressure of approx. +500
mmHg, shown on the reference instrument. Close clamp B.
13) Set the REF SET value on theAK 200 S / AK 200 ULTRA Sdialysis machine
display to the same value as shown on the reference instrument.
14) Press the Arrow button below REF SET to enter the value and wait for the
calibration display.
15) Press the Start UF Stop button to load the value into the EEPROM.

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16) To exit from the Calibration routine, press the Hold button.

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11.3.4 System Pressure Transducer calibration, BM 1
Equipment needed
11 Calibration manual

Pressure reference instrument, Calibration tube set.


Tolerance -700 to -500 mmHg 10%
-500 to +500 mmHg 5 mmHg or 3%
+500 to +750 mmHg 10%

Procedure
1) Start theAK 200 S / AK 200 ULTRA Sdialysis machine and enter the service
menu, Calibr / BM.
2) Set the display to:

3) Press the Start UF Stop button to enter calibration routine.


4) Connect Gambro reference instrument to the System Pressure Transducer
according to the figure.
5) Apply zero pressure by opening the three clamps A, B and C on the calibration
tube set.
6) Set the REF SET value on the display to 0 mmHg (with the Set knob).
7) Press the Arrow button below REF SET to enter the value and wait for the
calibration display.
8) Close clamp A. Apply a pressure of approx. -500 mmHg, shown on the reference
instrument. Close clamp B.
9) Set the REF SET value on theAK 200 S / AK 200 ULTRA Sdialysis machine
display to the same value as shown on the reference instrument.
10) Press the Arrow button below REF SET to enter the value and wait for the
calibration display.
11) The machine will now ask you to confirm to enter sensitivity calibration.To confirm:
press the Arrow button below Yes.
12) Open clamp A and B, then close clamp A again. Apply a pressure of approx. +500
mmHg, shown on the reference instrument. Close clamp B.
13) Set the REF SET value on theAK 200 S / AK 200 ULTRA Sdialysis machine
display to the same value as shown on the reference instrument.
14) Press the Arrow button below REF SET to enter the value and wait for the
calibration display.
15) Press the Start UF Stop button to load the value into the EEPROM.

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242 Calibration manual
16) To exit from the Calibration routine, press the Hold button.

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11.3.5 Level Detector calibration (Air detector), BM 5
Equipment needed
Drip chamber, Pressure meter, Calibration tube set.
Procedure
1) Start theAK 200 S / AK 200 ULTRA Sdialysis machine and enter the service
menu, Calibr / BM.
2) Set the display to:

3) Press the Start UF Stop button to enter calibration routine.


4) Insert a filled drip chamber. It is recommended that both the water and the drip
chamber have a temperature of 37 C. Make sure that the level detector (Air
detector) and drip chamber are dry and clean. The drip chamber shall be from the
same type of blood line as used during treatment.
5) Apply a pressure of 100 mmHg ( 10 mmHg), to the venous drip chamber. Use
the pressure meter as reference.

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Calibration manual 243
NOTE!
When creating a positive pressure in the venous drip chamber, a more treatment
11 Calibration manual

like condition is simulated as the pressure inside the drip chamber becomes
approximately the same as the venous pressure during treatment. The purpose
is to get a better contact between the chamber and the air detector head, which
results in a higher calibration value.

6) Wait for 2 minutes and then press the lit Arrow button.
7) The calibration is now performed automatically and the calibration factor is written
into the EEPROM.
8) The calibration result is displayed:

The value under LEVEL is the new alarm limit, which shall be 50 or higher. The
value under TRANSMIT is the transmission level, which is normally 255 but can
also be 160, if the air detector is exceptionally good.

11.3.6 Trouble shooting


If the calibration value has not stabilized within 5 minutes, the following error message
is displayed:

The reason for the error is probably that the drip chamber was moved during the
calibration. Make sure that the drip chamber is correctly inserted, that there is no air
bubbles in the water and that the temperature is 37 C.
If the alarm limit is too high or too low, the following error message is displayed:

If the problem remains, the air detector is malfunctioning and must be replaced.
If the verification of the calibration fails, the following error message is displayed:

The reason for the error is probably that the drip chamber was moved during the
calibration. If the problem remains, some circuit is broken on the BM CPU board.

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244 Calibration manual
11.3.7 Priming Detector calibration, BM 6
Equipment needed

11 Calibration manual
Reference tube
Procedure
1) Start theAK 200 S / AK 200 ULTRA Sdialysis machine and enter the service
menu, Calibr / BM.
2) Set the display to:

3) Press the Start UF Stop button to enter calibration routine.


4) The display shows:

5) Insert an empty reference tube in the priming detector. The reference tube shall
be from the same type of blood line as used during treatment.
6) Press the lit Arrow button.
7) The calibration is now performed automatically and the calibration factor is written
into the EEPROM.
8) The calibration result is displayed:

9) Press the lit Arrow button to confirm.

11.3.8 Blood Volume Sensor - BVS


Calibration of the BVS unit cant be done in the field. If necessary, replace the
complete BVS unit. Refer to chapter Replacements for information regarding exchange
of the BVS unit.
The functionality of the BVS unit can be tested during simulated treatment according to
AK 200 S / AK 200 ULTRA S Maintenance manual.

11.3.9 Temperature BM CPU Board calibration, BM 0


Equipment needed
Temperature meter.
Procedure
1) Place the Blood Monitor in service position.
2) Make sureAK 200 S / AK 200 ULTRA Sdialysis machine has been switched off
for at least 30 min. without being moved (to assure room temperature on the BM

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Calibration manual 245
CPU board). Also make sure the reference instrument transducer has been in
room temperature at least 30 minutes.
11 Calibration manual

3) Start theAK 200 S / AK 200 ULTRA Sdialysis machine and enter the service
menu, Calibr / BM.
4) Set the display to:

5) Press the Start UF Stop button to enter calibration routine.


6) Read the room temperature on a Temperature meter and set the REF SET value
on theAK 200 S / AK 200 ULTRA Sdialysis machine display to the same value.
7) Press the lit Arrow button below REF SET to enter the value and wait for the
calibration display.
8) Press the Start UF Stop button to load the value into the EEPROM.

11.3.10 Occlusion adjustment, blood pump/substitution flow pump


Check surface on the roller at the pump rotor, if it is damaged exchange the unit.
The roller unit should easily go back to upper end position when it has been
pressed down to end position. Exchange unit if it gets stuck in any position.

NOTE!
If the pump segment has a different wall thickness, the occlusion of the pump must
be adjusted to the correct wall thickness.
Use the gauge pins (stop/go) available in the kit K40158001. The kit includes following
three different gauge pins:
T = 1.1 (Stop pin = 1.1x2x0.7 = 1.5mm)
T = 1.6 (Stop pin = 1.6x2x0.7 = 2.2mm)
T = 2.0 (Stop pin = 2.0x2x0.7 = 2.8mm)
T = wall thickness of the tubing
Use following formula to calculate which gauge pin to use:
2 x wall thickness x 0,7 (mm)

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246 Calibration manual
Adjustment instruction
Check the range between the pump rollers and the path according to the picture

11 Calibration manual
below. Adjust range between the pump rollers and the path if it is necessary.

The GO pin should barely pass within the calibrating area.


The STOP pin is NOT allowed to pass in any point within the calibrating area.
NOTE!
Put grease on the GO and STOP pins when not used and store the pins in a plastic
bag to prevent it from corroding.

11.3.11 BPM test

11.3.11.1 Equipment needed


BPM test equipment, Pressure reference instrument, Calibration tube kit.

11.3.11.2 Test method


The functionality of the blood pressure module, BPM, is described in chapter Technical
Description.
The maintenance to be carried out for the module is to check the accuracy of the
pressure transducers, to check the air leakage and to check the inflation speed.
By entering the service menu it is possible to perform a check of the BPM device to
determine if it works correctly.
It is recommended to perform the test at least every 12 months or after a
repair/exchange of the BPM.
Procedure
1) Attach BPM cuff, 110350, tight to the BPM test equipment, K22151001.
2) Start theAK 200 S / AK 200 ULTRA Sdialysis machine with the main switch and
the ON/OFF button.

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Calibration manual 247
3) Enter Service mode, Diagnose / BM / Others and BPM
11 Calibration manual

11.3.11.3 BPM sub-test


Following sub-tests are included:
Air leakage test: measures that the equipment is airtight.
Inflation speed test: measures the time to fill the cuff with air.
Static pressure: Check of pressure transducer calibration
Each of the tests can be carried out separately but the above order for carrying out the
sub-tests is recommended.
Check that the results from the sub-tests not exceed following limits:
Air leakage: maximum 18 mmHg/ 3 min
Inflation speed: 2 -11 s
Static pressure: Maximum deviation from reference to be within 3 mm Hg.
50 3 mmHg
150 3 mmHg
250 3 mmHg

11.3.11.4 Check of air leakage


By entering this test mode the air leakage for the BPM module, cuff hose and cuff will
be tested automatically. Before entering the test mode cuff and cuff hose to be
connected to theAK 200 S / AK 200 ULTRA Sdialysis machine. Cuff to be wrapped
tight to the BPM test equipment.
BPM test equipment is used to simulate the patient arm circumference. The air
leakage is only tested for 90 sec but the value is recalculated for 3 minutes. If the
displayed value is above 18 mm Hg / 3 minutes, this indicates that there is a possible
air leakage in the system.
It is of course also possible to perform this test without the cuff and cuff hose
connected but then the test will only check for air leakage within
theAK 200 S / AK 200 ULTRA Sdialysis machine. In this case replace the cuff and
cuff hose by a tube, which is closed.

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248 Calibration manual
11.3.11.5 Check of inflation speed
By entering this test mode the capacity of the pump within the module will be tested

11 Calibration manual
automatically. Before entering the test mode cuff and cuff hose to be connected to
theAK 200 S / AK 200 ULTRA Sdialysis machine.
Cuff to be wrapped tight to the BPM test equipment. If the displayed time is above 11
seconds, this test indicates that the pump is worn-out.

11.3.11.6 Check of pressure transducer calibration and measured pressure


By entering this test mode it will be possible to check the actual pressure value of the
BPM pressure on theAK 200 S / AK 200 ULTRA Sdialysis machine display.
Before entering the test mode, pressure transducer calibration tube from kit
K13983002 to be connected to the BPM connector on
theAK 200 S / AK 200 ULTRA Sdialysis machine. No cuff and cuff hose to be
connected.

NOTE!
The pressure transducer calibration tube kit must be drained before being
connected, to make sure that no fluids or particles enters the BPM connector or
tubings. This might otherwise damage or destroy the sensitive BPM sensors.
When Current pressure: xxx mmHg is displayed it is possible to start applying the
external reference pressure.

NOTE!
The BPM is equipped with an over pressure protection. It is activated for
pressures above 300 mmHg.
The pressure transducer test is to be performed within approx. 2 minutes. Then
the pressure is automatically released.
To check the actual pressure value, external pressure reference instrument to be
connected and external pressure of 250, 150, 50 mmHg to be applied. Check deviation
from reference pressure instrument for displayed value.

11.4 Logging after calibration

11.4.1 GXL-logging
When calibration has been performed, it is recommended to log the values shown in
the logging table, see Section 11.4.3 Logging values on page250.
To run GXL-logging, the following facilities must be available and connected as shown
in fig:

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Calibration manual 249
11 Calibration manual

11.4.2 Procedure
Procedure
1) Start theAK 200 S / AK 200 ULTRA Sdialysis machine.
2) Press Volume Control button.
3) Set temperature value: 37.0 C.
4) Set main flow to: 500 ml/min.
5) Select suitable mode: BiCart, Acetate or Liquid Bicarbonate.
6) Let theAK 200 S / AK 200 ULTRA Sdialysis machine run for at least 15 minutes,
bypass off.
7) Start the GXL-program on the PC.

11.4.3 Logging values


NOTE!
The table on next page is valid for a main flow of 500 ml/min, and values are to
be used as guidance. Local deviations may occur due to differences in e.g.
incoming water temperature, operating altitude or ambient temperature.
Conductivity values correspond to the preset concentrate and set values.

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250 Calibration manual
Array Unit BiCart Acetate Liquid
Bicarbonate

11 Calibration manual
SRI 89 Heat rods duty cycle % < 30.00 < 30.00 < 30.00
SRI 14 Temperature vessel C 37.50 0.50 37.50 0.50 37.80 0.50
SRI 15 Temperature cell A control C 37.20 0.50 37.40 0.50 37.40 0.50
SRI 116 Temperature cell A PRS C 37.20 0.50 37.40 0.50 37.40 0.50
SRI 16 Temperature cell B PRS C 37.00 0.50 37.00 0.50 37.00 0.50
SRI 115 Temperature cell B control C 37.00 0.50 37.00 0.50 37.00 0.50
SRI 13 Conductivity cell A control mS/cm 12.30a 0.50b 0 0.50b 9.50c 0.50b
SRI 114 Conductivity cell A PRS mS/cm 12.30a 0.50b 0 0.50b 9.50c 0.50b
SRI 12 Conductivity cell B control mS/cm 14.30a0.50b 14.00a0.50b 14.30a0.50b
SRI 11 Conductivity cell B PRS mS/cm 14.30a 0.50b 14.00a 0.50b 14.30a 0.50b
SRI 8 Degassing pressure mmHg -580.0a 20.0 -630.0a 20.0 -580.0a 20.0
SRI 10 Flow out pressure mmHg -175.0 40.0 -175.0 40.0 -175.0 40.0
SRI 6 HPG pressure mmHg -95d 25.0 -95d 25.0 -95d 25.0
SRI 7 SAG pressure mmHg -120 50.0 -120 50.0 -120 50.0
SRI 4 PD pressure mmHg -125 15.0 -125 15.0 -125 15.0
SRI 9 Flow in pressure mmHg +175 50.0 +175 50.0 +175 50.0
SRI 71 A-pump deviation % < 5.0 - < 5.0
SRI 72 B-pump deviation % < 5.0 - < 5.0
SRI 73 Ac-pump deviation % - < 5.0 -
SRI 97 Degassing pump duty cycle % < 75.0 < 70.0 < 70.0
SRI 31 Flow out pump duty cycle % < 50.0 < 50.0 < 50.0
SRI 35 Flow in pump duty cycle % < 50.0 < 50.0 < 50.0
SRI 0 System pressure mmHg 0.0 5.0 0.0 5.0 0.0 50
SRI 1 Venous pressure mmHg 0.0 5.0 0.0 5.0 0.0 5.0
SRI 82 Arterial pressure mmHg 0.0 5.0 0.0 5.0 0.0 5.0
SRI 24 Blood leakage detector valuee - 0 10 0 10 0 10
SRI 25 Flow rate channel 1 ml/min 500 1 500 1 500 1
SRI 26 Flow rate channel 2 ml/min 500 3 500 3 500 3
SRB 0 Level det. transmit level 255 or - - -
160
SRB 89 Level det. comparation level min. 50 - - -
max 98
SRB 2 Priming detector blood level 15 - - - -
236
aCan be preset
bMaximum difference between conductivity cell A & B = 0.3 mS/cm. Maximum difference within a cell is 0.2 mS/cm
cDefault liquid concentrate
dDepending on pressure drop in ultrafilter (ULTRA or UFD)
eMachine in blood mode and no pressure at safety guard during 1 minute.

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Calibration manual 251
12 FM flow diagrams

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252 FM flow diagrams
!+3 &LOWPATH
&LOW 2ECIRCULATION %XPANSION
RESTRICTOR 2&6! VALVE CHAMBER

&,6! -IXING $EGASSING $EGASSING


(EATING /VER &LOW CHAMBER $26! PRESSURE CHAMBERWITH
VESSEL FLOW RESTRICTOR
$EGASSING LEVELDETECTOR
0
0!6! - RESTRICTOR
&ILTER #0
(EAT &ILTER
%X 4
4 #OND 4 P( SENSOR
CHANGER 0
.ON CELL!
$EGASSING
RETURN
VALVE PUMP 0 4
,$6!
#ONTROLPUMP #OND
,EVEL
).6! DETECTOR CELL"
0ROTECTIVEPUMP 4
#

3ELECT
.ON 3ELECT"AG 0"6!
RETURN
VALVE &/6! 2ESTRICTOR
0RESSURE &ILTER
REGULATOR &EEDINGPUMP! &LOW &LOW
0
OUTPUT OUTPUT
&ILTER
"#6! &EEDINGPUMP" PUMP PRESSURE

406! :%6!
&ILTER "I#ART

"I#ART
"LOODLEAK
"UBBLETRAP DETECTOR 5& MEASURING
&LOWINPUT %66! %-6! CELL
PRESSURE 0 4
#OND
&LOWINPUT CELL#
$EAIRATING  
2ESTRICTOR PUMP
0URE 0ARTICLE 0 CHAMBERWITH
WATER FILTER 0$ LEVELDETECTOR 4!6!
INLET
(#%.'AMBRO,UNDIA!"2EV0210

0
3!' 3AFETY (0'
$RAIN 0 BY PASS
"96!
UNIT

$)6!
0UREWATER
3ELECT"AGCONCENTRATE
3ELECT#ARTCONCENTRATE
!CONCENTRATE
"CONCENTRATE
$IALYSISFLUID
$IALYSATE
AK 200 S UFD Flow path
Flow Recirculation Expansion
restrictor RFVA valve chamber

FLVA Mixing Degassing Degassing


Heating Over Flow chamber DRVA pressure chamber with
vessel flow restrictor
Degassing level detector
P
PAVA M restrictor
Filter C P
Heat Filter
Ex- T
T Cond T pH-sensor
changer P
Non- cell A
Degassing
return
valve LDVA pump P T
Control pump Cond
Level
INVA detector cell B
Protective pump T
C

Select
Non- Select Bag PBVA
return
valve FOVA Restrictor
Pressure Filter
regulator Feeding pump A Flow Flow
P
output output
Filter
BCVA Feeding pump B pump pressure

TPVA ZEVA
Filter BiCart

BiCart
Blood leak
Bubble trap detector UF-measuring
Flow input EVVA EMVA cell
pressure P T
Cond
Flow input cell C
Deairating 2 1
Restrictor pump
Pure Particle P chamber with
10395 2006.05. Gambro Lundia AB. Rev. 02.2010

water filter PD level detector TAVA


inlet
HCEN10398

P
SAG Safety HPG
P
Dialysis fluid
Drain by-pass
FIVA filter BYVA
unit

U8000S DIVA
Pure water
SelectBag concentrate
SelectCart concentrate
A concentrate
B concentrate
Dialysis fluid
Dialysate
!+5,42!3
!+3 &LOWPATH
&LOW 2ECIRCULATION %XPANSION
RESTRICTOR 2&6! VALVE CHAMBER
7ATERFILTER 53 -IXING $EGASSING $EGASSING
&,6! (EATING /VER &LOW CHAMBER $26! PRESSURE CHAMBERWITH
VESSEL FLOW RESTRICTOR
$EGASSING LEVELDETECTOR
0
&LOW 0!6! - RESTRICTOR
&ILTER #0
RESTR (EAT &ILTER
ICTOR %X 4 4 P( SENSOR
CHANGER #OND 4 0
.ON CELL!
.ON $EGASSING
RETURN
RETURN VALVE PUMP 0 4
,$6!
VALVE #ONTROLPUMP
,EVEL #OND
).6! DETECTOR CELL"
0ROTECTIVEPUMP 4
#

3ELECT
.ON 3ELECT"AG 0"6!
RETURN
VALVE &/6! 2ESTRICTOR
0RESSURE &ILTER
REGULATOR &EEDINGPUMP! &LOW &LOW
0
OUTPUT OUTPUT
&ILTER
"#6! &EEDINGPUMP" PUMP PRESSURE

406! :%6!
&ILTER "I#ART

"I#ART
"LOODLEAK
"UBBLETRAP DETECTOR 5& MEASURING
&LOWINPUT %66! %-6! CELL
PRESSURE 0 4
#OND
&LOWINPUT CELL#
$EAIRATING  
2ESTRICTOR PUMP
0URE 0ARTICLE 0 CHAMBERWITH


WATER FILTER 0$ LEVELDETECTOR 4!6!


INLET
(#%.'AMBRO,UNDIA!"2EV210

0
3!' 3AFETY #76! (0'
0 0RESSURE $IALYSISFLUID
$RAIN BY PASS
($6! REGULATOR FILTER "96!
UNIT

&)6! Substitu- $)6!


0UREWATER tion fluid PORT 53
3ELECT"AGCONCENTRATE
3ELECT#ARTCONCENTRATE
!CONCENTRATE
"CONCENTRATE
$IALYSISFLUID
$IALYSATE
Index
A PBVA134
Air detector145 Recirculation Valve134
RFVA134
B TAVA134
Batteries145 TPVA134
Battery back-up164, 181 ZEVA134
technical data164, 181 FOVA- Flow Output bypass Valve134
BCVA- BiCart Valve134 Functional check88
Blood Pressure Monitor147 overview screen88
Blood Pump Unit145
Blood Volume Sensor145 H
BPM147, 156, 174 HDVA- HD/HDF Valve134
technical data156, 174 Heparin146
BVS145, 156, 174 Heparin Pump Unit146
technical data156, 174 Heparin Pump Unit146
BYVA- Bypass Valve134
I
C Infusion152
CWVA- Clean Water Valve134 height adjustment152
infusion pole152
D Inlet water9, 162, 179
Dialysis fluid156, 165, 174, 182 quality9, 162, 179
preparation, technical data156, 165, 174, INVA- Inlet Valve134
182
Diascan L
technical data158, 176 LDVA- Level Detector Valve134
Distribution Board148 Level Detector145
BM Analog Distribution Board148 Line Clamp Unit146
DIVA- Direct Valve134
Drip Chamber146 M
Level Adjustment146 Machine8, 162, 166, 168, 179, 183, 185
DRVA- Degass Resctriction Valve134 physical data166, 183
power supply8, 162, 179
E transportation and storage168, 185
Electromagnetic environment168, 185 Monitor stand152
EMVA- Emptying Valve134 bars, lifting positions152
EVVA- Evacuation Valve134 rear handle152
screws152
F
Fan146 O
FIVA- Filter Valve134 Operator's Panel146
FLVA- Flush Valve134
FM valves134 P
BCVA134 PAVA- Priming A Valve134
BYVA134 PBVA- Proportion Bypass Valve134
CWVA134 Physical data of the machine166, 183
DIVA134 Pressure Transducers146
DRVA134 Arterial Pressure Transducer146
EMVA134 System Pressure Transducer146
EVVA134 Venous Pressure Transducer146
FIVA134 Priming Detector147
FLVA134 Profiling158, 176
FOVA134 technical data158, 176
HDVA134
INVA134 R
LDVA134 Recirculation Valve134
PAVA134 RFVA- Return Flush Valve134

HCEN9281 Revision 03.2016


S
Single Needle142
Double Pump142
Single Pump142
Treatment142
Standards171, 188
Substitution fluid176
technical data176

T
TAVA- Taration Valve134
TPVA- Top Priming Valve134
Tray for concentrate containers152
Treatment overview screen86

U
Ultrafiltration157, 166, 176, 183
control, technical data157, 176
technical data166, 183

W
Wheels, lockable152

Z
ZEVA- Zeroing Valve134

HCEN9281 Revision 03.2016