Gentlelase Service Manual PDF

Candela Corporation Proprietary
GentleLASE
(MGL)
Service Manual
Models: 9914-00-0880
9914-00-0890
9914-00-0910
9914-00-0930
Candela Corporation
530 Boston Post Road
Wayland, MA 01778-1886
Telephone (508) 358-7637
8501-00-1741, Revision A
July 2003
GentleLASE Service Manual Candela Corporation Proprietary
Toll Free (800) 733-8550 ext.336 (Technical Assistance)

Toll Free (800) 73-LASER (Customer Service)
Page 2 PROPRIETARY 8501-00-1741 Revision A

Candela Corporation Proprietary GentleLASE Service Manual
Caution
Use of controls or adjustments or performance of procedures other than

those specified herein may result in hazardous radiation exposure.
Caution
Federal (USA) law restricts this device to sale by or on the order of a

physician.
Copyright 2002. All rights reserved. Printed in USA.
"Candela"
8501-00-1741, Revision A PROPRIETARY Page iii

TABLE OF CONTENTS
SECTION ONE THEORY OF OPERATION Revision

8501-00-1762 Theory of Operation, GentleLASE........................................................................A
SECTION TWO FIRMWARE DOCUMENT

1010-01-3020 Firmware Design Document, GentleLASE........................................................B2
1010-06-3020 Firmware Requirement Specification .................................................................B2
SECTION THREE SERVICE PROCEDURES

8503-01-0060 Inspection and cleaning of Optics .......................................................................02
8503-01-0821 Installation Procedure............................................................................................A
8503-01-0822 Routine Preventive Maintenance Procedure .....................................................A
8503-01-0560 Flashlamp Replacement Procedure ..................................................................C
8503-01-0570 Laser Head Replacement ....................................................................................D
8503-01-0600 Handpiece Lens Replacement procedure ........................................................C
8503-01-0823 Temperature Calibration Procedure ...................................................................A
8503-01-0776 DCD Pressure Verification....................................................................................A
8503-01-0824 High Voltage Calibration Procedure ...................................................................A
8503-01-0825 Head Detector Calibration Procedure ................................................................A
8503-01-0826 Laser Rail Alignment Procedure .........................................................................A
8503-01-0827 Focus Lens Replacement Procedure ................................................................A
8503-01-0828 Aiming Beam Alignment Procedure....................................................................01
8503-01-0829 Calport Calibration Procedure .............................................................................A
8503-01-0830 Bubble Sensor Calibration Procedure ...............................................................A
10-400-00144 GentleLASE System Performance & Usage Data Sheet................................C
10-040-01502 Form, Temp for Spot Size Verify...........................................................................02
8502-15-0208 Mini-GentleLASE PM Check List..........................................................................A
8502-00-0858 Treatment Guidelines ............................................................................................B
Page iv PROPRIETARY 8501-00-1741 Revision A

SECTION FOUR ENGINEERING DRAWINGS.................................................................................Revision
8501-02-1741 DRAWING PACKAGE A

Schematics Revision
7111-80-2230 Touch Panel Interface PCB...................................................................................06
7111-80-2510 HP Bulkhead PCB ..................................................................................................01
7111-80-2520 DCD Canister PCB.................................................................................................03
7111-80-2610 AC Distribution PCB...............................................................................................08
7111-80-2620 HV Bleeder PCB......................................................................................................06
7111-80-2630 CPU / I/O PCB..........................................................................................................03
7111-80-2650 Energy Detector PCB .............................................................................................03
7111-80-2660 Delivery HP PCB .....................................................................................................03
7111-80-2670 HP Slider PCB.........................................................................................................02
7111-80-2680 HP Switch PCB........................................................................................................02
9914-80-0880 System Schematic..................................................................................................08
Diagrams
9914-84-0880 GentleLASE Functional Block Diagram..............................................................04
9914-91-0880 GentleLASE Family Tree .......................................................................................A
9914-91-0910 GentleLASE-LE Family Tree.................................................................................04
Assembly Drawings/BOMs
7121-00-6700 Bom, Laser Head Assembly ................................................................................ A

7121-99-6700 Laser Head Assembly...........................................................................................C
7122-00-3287 Bom, Fluid Section Assembly ............................................................................. B
7122-99-3287 Fluid Section Assembly.........................................................................................C
7122-00-3289 Bom, Upper Chassis Assembly, ........................................................................A
7122-99-3289 Upper Chassis Assembly.....................................................................................B
7122-00-3292 Bom, AC Input Assembly.......................................................................................A
7122-99-3292 AC Input Assembly.................................................................................................B
7122-00-3297 Bom, Calibration Port Assembly, ........................................................................B
7122-99-3297 Calibration Port Assembly ....................................................................................B
7122-00-3298 Bom, Laser Rail Assembly, .................................................................................05
7122-99-3298 Laser Rail Assembly..............................................................................................02
7122-00-3300 Bom, Fiber Receptacle Assembly, ..................................................................... A
7122-99-3300 Fiber Receptacle Assembly..................................................................................A
7122-00-3301 Bom, Head Detector Assembly, .......................................................................... 04
7122-99-3301 Head Detector Assembly ......................................................................................02
7122-00-3302 Bom, HV Section Assembly .................................................................................A
7122-99-3302 HV Section Assembly.............................................................................................B
8501-00-1741, Revision A PROPRIETARY Page v

Assembly Drawings/BOMs Cont. Revision
7122-00-3306 Bom, DCD Option Assembly, .............................................................................. B

7122-99-3306 DCD Option Assembly...........................................................................................A
7122-00-3316 Bom, DI Heat exchanger Assembly ...................................................................A
7122-99-3316 DI Heat exchanger Assembly...............................................................................A
7122-00-3317 Bom, Heater Manifold Assembly ........................................................................03
7122-99-3317 Heater Manifold Assembly....................................................................................A
7122-00-3319 Bom, Display Bezel Assembly, ...........................................................................A
7122-99-3319 Display Bezel Assembly........................................................................................A
7122-00-3325 Bom, Focusing Lens Assembly, ......................................................................... 02
7122-99-3325 Focusing Lens Assembly .....................................................................................05
7122-00-3326 Bom, Aiming Beam Assembly, ........................................................................... 05
7122-99-3326 Aiming Beam Assembly........................................................................................02
7122-00-3327 Bom, Beam Shutter Assembly, ...........................................................................03
7122-99-3327 Beam Shutter Assembly........................................................................................A
7122-00-3333 BOM, Aiming Beam, Diode 650nm .....................................................................04
7122-99-3333 Aiming Beam, Diode 650nm ................................................................................A
7122-00-3339 BOM, Distance Gauge Stick, MGL .......................................................................A
7122-99-3339 Distance Gauge Stick, MGL ..................................................................................02
7122-00-3340 Bom, 6/8/10 mm Delivery System Assembly, w/DCD .................................... C
7122-99-3340 6/8/10 mm Delivery System Assembly, w/DCD................................................03
7122-00-3342 Bom, 12/15/18 mm Delivery System Assembly, w/DCD ................................C
7122-99-3340 12/15/18 mm Delivery System Assembly, w/DCD ................................03
7122-00-3309 Bom, 12mm Delivery System Assembly, w/DCD, MGL-LE, .......................... 02
7122-99-3340 12/15/18 mm Delivery System Assembly, w/DCD ...........................................03
7122-00-3341 Bom, 6/8/10 mm Delivery System Assembly, w/o DCD ..................................B
7122-99-3341 6/8/10 mm Delivery System Assembly, w/o DCD.............................................03
7122-00-3343 Bom, 12/15/18 mm Delivery System Assembly, w/o DCD ............................B
7122-99-3341 12/15/18 mm Delivery System Assembly, w/o DCD ........................................03
7122-00-3281 Bom, 12 mm Delivery System Assembly, w/o DCD, MGL-LE, ...................... 02
7122-99-3341 12/15/18 mm Delivery System Assembly, w/o DCD........................................03
7122-00-3348 BOM, DI pump MGL ...............................................................................................A
7122-99-3348 DI pump MGL...........................................................................................................A
7122-00-3349 BOM, DCD Valve, MGL ...........................................................................................A
7122-99-3349 DCD Valve, MGL......................................................................................................B
7122-00-3350 BOM, 6/8/10 mm Lens Cap, MGL .......................................................................A
7122-99-3350 6/8/10 mm Lens Cap, MGL ..................................................................................A
7122-00-3351 BOM, 12/15/18 mm Lens Cap, MGL ..................................................................A
7122-99-3351 12/15/18 mm Cap, MGL .......................................................................................A
8901-00-9301 PM Kit MGL ...............................................................................................................01
Page vi PROPRIETARY 8501-00-1741 Revision A

SECTION FIVE REFERENCE
8501-00-1741, Revision A PROPRIETARY Page vii

Page viii PROPRIETARY 8501-00-1741 Revision A

AK 200 S - Operator’s manual
Program version 8.xx
1. Before you get started - general information
2. Description - the machine and its components
3. Controlling the machine - general guidelines
4. Hemodialysis, double needle treatment
5. Hemodialysis, single needle treatment
6. Isolated UF
7. Profiling
8. Hemodiafiltration, low volume
9. BVS - Blood Volume Sensor
10. BPM - Blood Pressure Monitor (option)
11. Diascan
12. Hygiene and maintenance
13. Technical data and specifications
14. Alarm list, Attention alarm list and Technical alarm list
15. Major changes in operator’s manual
16. Index
HCEN9751 Revision.12.2005
Contents
1. Before you get started - general information
How to use this manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:2
Definitions of expressions used in this manual . . . . . . . . . . . . . . . . . . 1:4
General precautions before use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:5
Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:8
Safety philosophy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:9
The preparation of dialysis fluid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:12
Inlet water requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:12
Preparation of the dialysis fluid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:12
UFD- Ultrafiltered Dialysis Fluid (option) . . . . . . . . . . . . . . . . . . . . . . 1:12
Ultrafilters; frequency of change . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:12
List of concentrates, accessories and disposables, for use with the
AK 200 S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:13
Concentrates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:13
Lines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:14
Dialyzers/Ultrafilter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:14
Infusion fluid for low volume HDF . . . . . . . . . . . . . . . . . . . . . . . . 1:15
Blood pressure measurement accessories . . . . . . . . . . . . . . . . . . . . 1:15
List of symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:16
CE-marking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:18
Manufacturer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:18
Copyright . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:18

Blood monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2:2
BM 200 - Single Pump, BM 202 - Double Pump . . . . . . . . . . . . . . . . . 2:2
Fluid monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2:4
FM 202 - Acetate and Bicarbonate . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2:4
Rear of the machine - without options . . . . . . . . . . . . . . . . . . . . . . . . . . . 2:6
Rear of the machine - options included . . . . . . . . . . . . . . . . . . . . . . . . . . . 2:8
Monitor stand . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2:10
MS 200: Adjustable height: five fixed positions . . . . . . . . . . . . . . . . . . 2:10
MS 202: Electrically adjustable height . . . . . . . . . . . . . . . . . . . . . . . . . 2:12

Operator’s panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:2
Hygiene group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:4
Mode group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:5
Concentrate stand-by mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:6
Procedure for manual activation . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:7
Resume fluid preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:7
Therapy group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:9
Treatment overview group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:10
Bargraph display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:10
Flow diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:10
Time display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:11
Parameter buttons and their displays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:12
Reset possibilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:16
Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:17
Alarm indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:17
Alarm function of the parameter buttons . . . . . . . . . . . . . . . . . . . . . . . 3:18
Override possibilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:20
Stand-by group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:22
Display and setting group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:23
Information display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:23
Treatment overview screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:24
Parameters shown on Treatment overview screen . . . . . . . . . . . . . . . . 3:25
Function check overview screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:26
Tests shown on Function check overview screen . . . . . . . . . . . . . . . . . 3:27
The eight commandments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:28
Setting of parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:29
Downloading treatment parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:32
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:33
The ultrafiltration control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:34
Protective system for ultrafiltration . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:35
Power failure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:38
Returning the blood during a power failure . . . . . . . . . . . . . . . . . . . . . 3:38
Battery back-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:38
Recovery from a short power failure . . . . . . . . . . . . . . . . . . . . . . . . . . 3:39
Recirculation during treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:40
Reconnection of the patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:40
Change of blood pump segment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:42
BiCart/SelectCart change during treatment . . . . . . . . . . . . . . . . . . . . . . . . 3:43

Double needle treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:2
Check before starting the machine . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:2
Start the machine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:2
Function check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:3
Select concentrates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:4
Connect concentrates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:6
SelectCart and SelectBag together with BiCart . . . . . . . . . . . . . 4:7
Acidic concentrate and BiCart . . . . . . . . . . . . . . . . . . . . . . . . . . 4:8
Acidic concentrate and liquid bicarbonate concentrate . . . . . . . 4:8
Acetate concentrate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:8
Start the machine - continued . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:9
Attaching the dialyzer and the blood lines . . . . . . . . . . . . . . . . . . . . . . 4:11
Dialyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:11
Arterial blood line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:12
Preparations if the heparin pump is to be used . . . . . . . . . . . . . 4:14
Venous blood line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:16
Priming . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:17
Priming and rinsing the extracorporeal circuit . . . . . . . . . . . . . . . . 4:17
Initiating . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:19
Set the treatment parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:19
Connect the patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:20
Start the treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:21
Pressure alarm limits setting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:22
Venous/Arterial pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:22
TMP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:22
Discontinuing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:24
Automatic emptying of BiCart, SelectCart and SelectBag . . . . . . . . 4:24
Discontinuing procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:25
Confirm treatment end . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:25
If desired, start emptying BiCart or BiCart, SelectCart and
SelectBag . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:25
Return the blood . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:25
After-treatment handling of the machine . . . . . . . . . . . . . . . . . . 4:26

Single needle treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:2
General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:2
Glossary of single needle parameters and key terms . . . . . . . . . . . . 5:3
Single needle treatment with two blood pumps - BM 202 only . . . . . . . . . 5:4
Preparations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:4
Priming . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:6
Priming and rinsing procedure in double needle mode, finishing
in single needle/double pump mode . . . . . . . . . . . . . . . . . . . . . 5:6
Priming and rinsing procedure in single needle/double pump
mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:9
Initiating . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:11
Always check/adjust . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:11
TMP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:15
Discontinuing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:17
Single needle treatment with one blood pump . . . . . . . . . . . . . . . . . . . . . 5:18
Preparations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:18
Single needle / single pump settings . . . . . . . . . . . . . . . . . . . . . . . . 5:19
For both pressure- and time-controlled phases . . . . . . . . . . . . . 5:19
Only for pressure-controlled phases . . . . . . . . . . . . . . . . . . . . . 5:21
Only for time-controlled phases . . . . . . . . . . . . . . . . . . . . . . . . 5:22
Discontinuing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:23
Double needle to single needle treatment - change during treatment . . 5:24
Resume treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:24
Discontinuing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:27
6. Isolated UF
7. Profiling
Profiling of Na+ and HCO3- dialysis fluid concentration . . . . . . . . . . . . . 7:2
Profiling of ultrafiltration rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7:4
Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7:5
Curve Setting/Change/Cancellation: . . . . . . . . . . . . . . . . . . . . . 7:5
Activation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7:5
Verification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7:5
Activation of profiling with already preset models . . . . . . . . . . . . . . . . 7:7
Verification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7:7

General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:2
Protective system for low volume HDF . . . . . . . . . . . . . . . . . . . . . . . . 8:2
The following conditions have to be met in order to fulfil the
accuracy of the measuring system . . . . . . . . . . . . . . . . . . . . . . . . . . 8:3
Start up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:4
Priming and rinsing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:6
Initiating and starting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:7
Bolus infusion possibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:8
Hemodiafiltration, low volume, single needle, single pump . . . . . . . . . 8:8

General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9:2
∆BV text information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9:3
Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9:4
Graphs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9:5
BVS ON/OFF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9:6
BVS Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9:6
BVS On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9:7
10.BPM - Blood Pressure Monitor (option)

General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10:2
Patient factors which affect readings . . . . . . . . . . . . . . . . . . . . . . . . . . 10:3
Handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10:5
The BPM screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10:6
BPM button pressed once . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10:6
BPM button pressed twice . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10:7
Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10:8
Alarm limits setting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10:8
Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10:9
Start/Stop . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10:10
Start . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10:10
Stop . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10:10
11.Diascan
General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:2
Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:2
How the measuring process is performed by the machine . . . . . . . . . . 11:2
Glossary of Diascan parameters and key terms . . . . . . . . . . . . . . . . . . 11:3
Precautions before use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:4
Handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:5
Screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:5
The first screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:6
Measurement mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:6
Alarm limit for clearance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:6
Measurement result values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:7
The second screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:8
Distribution volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:8
Distribution volume calculation using the Watson formula . . . . 11:9
Forecast . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:10
Target . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:10
Alarm limit for Kt/V . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:10
Measurement result values when distribution volume has not been
set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:11
Second screen symbol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:11
Measurement result values when distribution volume has been set . 11:12
The third screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:13
Latest measured values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:13
Accumulated and forecast values . . . . . . . . . . . . . . . . . . . . . . . . . . 11:13
Time to target . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:14
Third screen symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:14
Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:15
Clearance alarm limit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:15
Kt/V alarm limit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:15
Step-by-step instructions for measuring clearance and Kt/V . . . . . . . . . . 11:16
Single clearance measurement check . . . . . . . . . . . . . . . . . . . . . . . . . . 11:16
Continuous measuring of clearance . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:18
Single Kt/V and clearance measurement check . . . . . . . . . . . . . . . . . . 11:20
Continuous measuring of Kt/V and clearance . . . . . . . . . . . . . . . . . . . 11:22
12.Hygiene and maintenance

General hygiene and maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:2
Glossary of disinfection terms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:3
Disinfection history . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:4
List of disinfection screen symbols . . . . . . . . . . . . . . . . . . . . . . . . . 12:4
Schedule for hygiene and maintenance . . . . . . . . . . . . . . . . . . . . . . . . . 12:6
When the machine is planned not to be in use . . . . . . . . . . . . . . . . 12:7
Characteristics of different disinfection, decalcification and cleaning
agents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:8
Hygiene - Heat disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:9
General - Heat disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:9
Performing Heat disinfection program . . . . . . . . . . . . . . . . . . . . . . . . 12:11
Performing Heat disinfection program with CleanCart . . . . . . . . . . . . 12:12
Performing Heat disinfection program with liquid citric acid . . . . . . . 12:13
Performing integrated Heat disinfection program with WRO 300 H . . 12:14
Automatic start of Heat disinfection program . . . . . . . . . . . . . . . . . . . 12:16
Automatic switch off after Heat disinfection program . . . . . . . . . . . . . 12:17
Integrated Heat disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:17
Hygiene - Chemical disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:18
General - Chemical disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:18
Chemical disinfectants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:19
Performing Chemical disinfection program . . . . . . . . . . . . . . . . . . . . . 12:20
Filling the machine with chemical disinfectant . . . . . . . . . . . . . . . . 12:21
Residual test after Chemical disinfection . . . . . . . . . . . . . . . . . . . . . . . 12:23
Central Chemical disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:24
Performing central Chemical disinfection . . . . . . . . . . . . . . . . . . . . . . 12:24
Hygiene - Rinse/Drain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:25
Performing Rinse/Drain program . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:25
Performing Rinse/Drain program with CleanCart . . . . . . . . . . . . . . . . 12:26
Automatic start of Rinse/Drain program . . . . . . . . . . . . . . . . . . . . . . . 12:28
Automatic switch off after Rinse/Drain program . . . . . . . . . . . . . . . . 12:29
Maintenance - the flow path . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:30
The flow path . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:30
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:30
Decalcification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:30
Ultrafilter; how to change . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:31
Ultrafilter replacement reminder . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:32
Maintenance - the exterior of the machine . . . . . . . . . . . . . . . . . . . . . . . . 12:33
The outside . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:33
Top tray . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:33
Blood pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:33
Blood leak detector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:33
BPM cuff . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:34
13.Technical data and specifications

Performance and specification - Control System . . . . . . . . . . . . . . . . . . . . 13:2
Blood Flow Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:2
Air Detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:3
Heparin Administration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:3
Blood Volume Sensor (BVS) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:3
Blood Pressure Monitor (BPM) . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:3
Dialysis fluid preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:4
Dialysis fluid preparation (BiCart Select mode only) . . . . . . . . . . . . 13:5
Ultrafiltration control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:5
Substitution fluid (Low volume HDF) . . . . . . . . . . . . . . . . . . . . . . 13:5
Profiling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:5
Diascan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:6
Disinfection and Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:6
Water supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:9
Drain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:10
Power supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:10
Connection of external equipment . . . . . . . . . . . . . . . . . . . . . . . . . 13:10
Battery Back-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:12
Performance and specification - Supervisory system . . . . . . . . . . . . . . . . . 13:13
Blood Pressure Supervision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:13
Air Detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:14
Ultrafiltration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:15
Blood leak detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:15
Physical data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:16
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:16
Materials in contact with water, concentrates and dialysis fluid . . . . . . . . . 13:17
Polymers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:17
Metals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:17
Others . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:17
Environmental data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:18
Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:18
Transportation and storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:18
Electromagnetic environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:18
Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:22
14.Alarm list, Attention alarm list and Technical alarm

list
Alarm list . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14:2
Attention alarm list . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14:9
Technical alarm list . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14:45
15.Major changes in operator’s manual
16.Index
Figures
Figure 2:1 Blood monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2:2
Figure 2:2 Fluid monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2:4
Figure 2:3 Rear of the machine - without options . . . . . . . . . . . . . . . . . 2:6
Figure 2:4 Rear of the machine, options included . . . . . . . . . . . . . . . . . 2:8
Figure 2:5 Monitor stand, five fixed positions . . . . . . . . . . . . . . . . . . . . 2:10
Figure 2:6 Monitor stand, electrically adjustable . . . . . . . . . . . . . . . . . . 2:12

Figure 3:1 Operator’s panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:3
Figure 3:2 Concentrate stand-by mode, activation . . . . . . . . . . . . . . . . . 3:7
Figure 3:3 Flow diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:10
Figure 3:4 Treatment overview screen . . . . . . . . . . . . . . . . . . . . . . . . . . 3:24
Figure 3:10 Function check overview screen . . . . . . . . . . . . . . . . . . . . . 3:26
Figure 3:11 Temp button and the information display . . . . . . . . . . . . . 3:28
Figure 3:13 Temp button and the information display . . . . . . . . . . . . . 3:29
Figure 3:14 Downloading treatment parameters . . . . . . . . . . . . . . . . . . 3:32

Figure 4:1 Select Bicarbonate and type of concentrate . . . . . . . . . . . . . 4:4
Figure 4:2 Select SelectBag . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:5
Figure 4:3 Connect the SelectCart cartridge and the SelectBag . . . . . . . 4:7
Figure 4:4 Arterial blood line in HD, set-up . . . . . . . . . . . . . . . . . . . . . 4:13
Figure 4:5 Change position of the heparin pump holder . . . . . . . . . . . . 4:14
Figure 4:6 Syringe attached to heparin pump . . . . . . . . . . . . . . . . . . . . 4:14
Figure 4:7 Venous blood line in HD, set-up . . . . . . . . . . . . . . . . . . . . . 4:16

Figure 5:1 Arterial blood line with expansion chamber in HD, single
needle/double pump, set-up . . . . . . . . . . . . . . . . . . . . . . . . 5:4
Figure 5:2 Venous blood line with expansion chamber in HD, single
needle/double pump, set-up . . . . . . . . . . . . . . . . . . . . . . . . 5:5
Figure 5:5 Venous blood line with attached expansion chamber in HD,
single needle/single pump, set-up . . . . . . . . . . . . . . . . . . . . 5:18
7. Profiling
Figure 7:1 3 different graphs for profiling sodium and bicarbonate . . . 7:2
Figure 7:2 Profiling, Degressive graph . . . . . . . . . . . . . . . . . . . . . . . . . 7:3
Figure 7:3 Profiling, Progressive graph . . . . . . . . . . . . . . . . . . . . . . . . . 7:3
Figure 7:4 Linear graph for UF rate profiling . . . . . . . . . . . . . . . . . . . . 7:4

Figure 8:1 Infusion line in HDF low volume, set-up . . . . . . . . . . . . . . . 8:5
Figure 9:1 BVS, relative blood volume graph . . . . . . . . . . . . . . . . . . . . 9:3
Figure 9:2 BVS, relative blood volume graph . . . . . . . . . . . . . . . . . . . . 9:4
Figure 9:3 BVS, combination of graphs . . . . . . . . . . . . . . . . . . . . . . . . 9:5
Figure 9:4 BVS, graphs without relative blood volume graph . . . . . . . . 9:6
Figure 9:5 BVS turned on before the reference value has been acquired 9:7
Figure 9:6 BVS, the reference value not related to the treatment start . 9:7
Figure 9:7 BVS, interrupted relative blood volume graph . . . . . . . . . . . 9:8
10.BPM - Blood Pressure Monitor (option)

Figure 10:1 BPM, screen with latest measured values and graph . . . . . . 10:6
Figure 10:2 BPM, screen with the 8 latest measured values . . . . . . . . . . 10:7
Figure 10:3 BPM, setting the alarm limits . . . . . . . . . . . . . . . . . . . . . . . 10:8
Figure 10:4 BPM, measurement check in progress . . . . . . . . . . . . . . . . 10:10
11.Diascan
Figure 11:1 Diascan screens, without set distribution volume . . . . . . . . 11:5
Figure 11:2 Diascan screens, set distribution volume . . . . . . . . . . . . . . 11:5
Figure 11:3 First Diascan screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:6
Figure 11:4 First Diascan screen with measurement result values . . . . . 11:7
Figure 11:5 Second Diascan screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:8
Figure 11:6 The Watson screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:9
Figure 11:7 Second Diascan screen with set distribution volume . . . . . 11:10
Figure 11:8 Second Diascan screen with measurement result values,
distribution volume not set . . . . . . . . . . . . . . . . . . . . . . . . . 11:11
Figure 11:9 Second Diascan screen with measurement result values, set
distribution volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:12
Figure 11:10 Third Diascan screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:13
Figure 11:11 Diascan, activated single measurement check . . . . . . . . . . 11:16
Figure 11:12 Diascan, activated continuous measuring . . . . . . . . . . . . . 11:18
Figure 11:13 Diascan, activated single measurement check . . . . . . . . . . 11:20
Figure 11:14 Diascan, distribution volume set . . . . . . . . . . . . . . . . . . . . 11:21
Figure 11:15 Diascan, activated continuous measuring . . . . . . . . . . . . . 11:22
Figure 11:16 Diascan, distribution volume, Kt/V target and alarm limit
set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:23
12.Hygiene and maintenance

Figure 12:1 Heat disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:11
Figure 12:2 Auto Heat . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:16
Figure 12:3 Chemical disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:20
Figure 12:4 Rinse/Drain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:25
Figure 12:5 Auto Rinse . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:28
Figure 12:6 Ultrafilter replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:32
Figure 12:7 BPM cuff, removal procedure of rubber bladder from cloth
bag
1. Small hole
2. Large hole . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:34
Chapter 1
Before you get started - general

information
How to use this manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:2
Definitions of expressions used in this manual . . . . . . . . . . . . . . . . . . 1:4
General precautions before use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:5
Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:8
Safety philosophy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:9
The preparation of dialysis fluid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:12
Inlet water requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:12
Preparation of the dialysis fluid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:12
UFD- Ultrafiltered Dialysis Fluid (option) . . . . . . . . . . . . . . . . . . . . . . 1:12
Ultrafilters; frequency of change . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:12
List of concentrates, accessories and disposables, for use with the
AK 200 S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:13
Concentrates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:13
Lines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:14
Dialyzers/Ultrafilter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:14
Infusion fluid for low volume HDF . . . . . . . . . . . . . . . . . . . . . . . . 1:15
Blood pressure measurement accessories . . . . . . . . . . . . . . . . . . . . 1:15
List of symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:16
CE-marking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:18
Manufacturer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:18
Copyright . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1:18
Program version 8.xx AK 200 S Operator’s manual - Definitions 1:1
How to use this manual
Below is a brief explanation of how the chapters in this manual are
structured and are intended to be used.
Chapter 1; Before you get started - general information

This chapter contains information to be read before using the AK 200 S
machine.
Chapter 2; Description - the machine and its components

This chapter contains component descriptions of the blood monitor, the
fluid monitor, the rear of the machine and the monitor stands.
Chapter 3; Controlling the machine - general guidelines

This chapter contains explanations of how the machine is to be
controlled. This is, for example, how to use the buttons of the Operator’s
panel, their alarms functions, how parameters are to be set and how to
use the concentrate stand-by mode. The Treatment- and Function check
overview screens are explained as well as the ultrafiltration control, and
information is provided on what to do if a power failure occurs.
Chapter 4; Hemodialysis, double needle treatment

This chapter contains instructions on how to perform hemodialysis with
two needles, using the AK 200 S machine. The chapter begins with how
to start the machine and continues with how to attach the dialyzer and
the blood lines, the priming procedure, starting the treatment, setting of
parameters, and finishes with the discontinuing procedure.
Chapter 5; Hemodialysis, single needle treatment

This chapter contains instructions on how to perform hemodialysis
with one needle, either using the double pump (if BM 202) or single
pump function. The chapter is based on chapter 4 with added specific
instructions for single needle treatment.
Chapter 6; Isolated UF
This chapter contains instructions on how to perform isolated
ultrafiltration.
Chapter 7; Profiling
This chapter contains instructions on how to use the profiling function
for ultrafiltration, as well as for the dialysis fluid concentration of sodium
and bicarbonate.
Chapter 8; Hemodiafiltration, low volume

This chapter contains instructions on how to perform low volume
hemodiafiltration using the AK 200 S machine. The chapter is based on
chapter 4 with added specific instructions for low volume HDF treatment.
There is a general section describing the protective system for low volume
HDF, instructions for the bolus infusion possibility is also included.
1:2 AK 200 S Operator’s manual - Definitions Program version 8.xx
Chapter 9; BVS - Blood Volume Sensor
This chapter contains instructions on how to use the BVS, which
measures changes in the blood volume of the patient continuously during
treatment. The chapter begins with a general section where handling,
alarm function and graphs are explained, and finishes with On and Off
instructions.
Chapter 10; BPM - Blood Pressure Monitor

This chapter contains instructions on how to use the BPM (if installed),
which measures blood pressure and pulse rate. A particular blood
pressure measurement cuff and a cuff hose are to be used. The chapter
includes explanations of how the BPM is handled using the BPM button
and the BPM screens, and also describes the alarm function. The BPM
can be used manually if only one measurement check is to be done, or
at set intervals during treatment.
Chapter 11; Diascan

This chapter contains instructions on how to use the Diascan function,
which measures clearance (K) and dialysis dose (Kt or Kt/V). The
chapter is divided into two parts where the first section includes general
information about the Diascan function, handling using the Kt/V button,
explanation of the Diascan screens, and alarm functions. The second
section includes step-by-step instructions for measuring clearance and
Kt/V, single or continuous measuring.
Chapter 12; Hygiene and maintenance

This chapter contains information and instructions concerning the
hygiene and maintenance of the AK 200 S that should be carried out by
the operator of the machine. The chapter begins with a general section
where a schedule for hygiene and maintenance is included. The Hygiene
sections contain general information and instructions on how to perform
the disinfection programs. The Maintenance sections include instructions
on the maintenance of the flow path and the exterior of the machine.
Chapter 13; Technical data and specifications

This chapter contains technical specifications of the control- and
supervisory systems of the machine. It also includes physical data;
materials which come into contact with water, concentrates and dialysis
fluid; environmental data; and a list of standards which the machine
complies with.
Chapter 14; Alarm list, Attention alarm list and Technical alarm list
This chapter contains lists of alarms, attention alarms and technical
alarms. The alarm list includes additional information and possible causes
of parameter button alarms. The attention- and technical alarm lists
include additional information concerning the alarms, describing the
alarm text more in detail and giving suggestions about measures to take.
The attention- and technical alarm lists are shown in alphabetical order.
Chapter 15; Major changes in operator’s manual
This chapter includes brief information about major changes between the
current and previous program versions of the machine that have been
made in the manual. The changes mentioned are mostly information
concerning the operation of the machine and are specifically addressed
to the operator.
Note
• A small reference number beside the figures in this manual has been
added to simplify manual production.
Note
Definitions of expressions used in this manual

WARNING
Is used to alert the user/operator not to take a certain action, which
if taken can cause a potential hazard and result in a serious adverse
reaction, injury or death. A warning may also be used to alert the
user/operator to take a certain action to avoid the potential hazard
as above.
WARNING
CAUTION
Is used to alert the user/operator to take a certain action to protect
against a potential hazard which, if ignored, could have an adverse
effect on the patient or the device. A caution may also be used to
alert the user/operator not to take a certain action to avoid the
potential hazard as above.
CAUTION
Note
• A reminder to the user/operator on normal treatment activity and on
what is a suitable action in a particular situation.
Note
This symbol indicates that it is possible to preset the value of a

parameter. This can be done to adapt the settings of the machine to
correspond with the routines of the user/clinic. It has to be done in
service mode by an authorized service technician.
All values mentioned in this manual are default values set in the machine
when it was manufactured. It is important to check with the service
technician if values have been changed, and if so, which ones.
For instance, it is possible to preset the machine for which mode to start
up in, some alarm limits, some functions and options.
General precautions before use
WARNING
Unauthorized modifications, alterations or repair and lack
of maintenance or calibration of the AK 200 S may result in
malfunctioning or have other serious consequences for the safe
operation of the equipment.
WARNING
CAUTION
The AK 200 S may only be operated by persons trained in
hemodialysis and who have studied the instructions in this manual.
The user/operator should draw special attention towards the text
valid for the Safety philosophy of the machine. See section "Safety
philosophy" in chapter 1. Verify that the first digit of the program
version of both the machine and the manual is the same. If the
AK 200 S does not perform as described in this manual, it should
not be used until the condition is rectified.
When unpacking, check the equipment for any signs of damage. If

the equipment is in any way damaged, proper operation can not
be assured.
Patients connected to the AK 200 S should be monitored by

competent medical personnel, learned intermediaries or the like,
since life threatening circumstances sometime arise that may not
activate alarms. The operator should pay attention to all appropriate
alarms and follow the instructions, warnings, cautions, and notes
given in this manual. It is imperative that the machine has passed
the function check before connecting a patient.
During installation all calibration checks must be completed before

the machine is used to dialyze a patient.
The AK 200 S needs special precautions regarding EMC and

needs to be installed and put into service according to the EMC
information provided in the "Technical data and specifications"
chapter in this manual.
The use of mobile telephones or communication equipment in the

vicinity of the AK 200 S could adversely influence the performance
of the machine. For further information, see the "Technical data and
specifications" chapter in this manual.
The AK 200 S will perform as designed only if it is used and

maintained in accordance with Gambro’s instructions. Any
warranties made by Gambro with respect to the AK 200 S are void
if the equipment is not used in accordance with the instructions
provided. Gambro will not accept responsibility for any damage or
injury resulting from improper use or maintenance or unauthorized
repair.
CAUTION → → →
→ → → CAUTION
Preventive inspection, maintenance and calibration of the AK 200 S
shall be performed by a fully trained service technician according
to the Maintenance Manual in the AK 200 S Service Manual which
can be ordered from your Gambro representative. It is mandatory
for preventive maintenance to be performed at least every other
year. Yearly maintenance is recommended. The interval between
preventive maintenance procedures might differ due to operating
environment variations.
The AK 200 S dialysis machine is in compliance with certain

requirements concerning patient leakage current from the dialysis
fluid in accordance with international standards and regulations.
When a central venous catheter is used, and the tip of the catheter is
close to the heart, it is however necessary to take extra precautions
to minimize the risk for arrythmia due to leakage currents. For these
treatments it is necessary to connect the potential equalization
conductor between the AK 200 S and the potential equalization bus
bar in the electrical installation.
To minimize the leakage currents from other electrical equipment it
is recommended to place such equipment outside the patient area.
Any equipment within the patient area shall fulfil the IEC 60601-1
and IEC 60601-1-1 standards and be a part of the potential
equalization. One way to minimize the leakage currents from
equipment within the patient area is to electrically isolate it. Make
sure leakage current values are below respective limit required by
CF type applied parts. Check with service technician.
If your clinic/hospital use a central venous catheter during
treatments please make sure your machine is equipped with a
potential equalization connection. If not please contact your local
Gambro Service Technician for further assistance.
CAUTION
Note
• This operator’s manual provides instructions necessary for the proper
operation of the AK 200 S. It is not a guide for the administration
of hemodialysis.
• Machines are not disinfected before delivery. Always perform a

chemical disinfection after installation, before initial use.
• When accuracy ranges are written as e.g. ”(±1 ml/min or ±1%)” the
widest range is valid.
• During transportation and storage the equipment has to be kept in

its original packing. If transportation or storage time is more than
15 weeks the environmental data relating to the operation has to
be followed.
• For the qualified technician the AK 200 S Service Manual is available.

The Service Manual provides all of the necessary information for
installation and safe and required maintenance of the machine.
• It is important that the protective earth in the installation is of high

quality.
• For the purpose of protecting the environment the AK 200 S must not
be disposed with general domestic waste, but shall be separately
collected for dismantling and recovery. Where applicable national
regulations shall be applied. Consult your local Gambro distributor
for information.
Note
Intended use
The Gambro AK 200 S System is designed to be used as a single patient
machine to perform hemodialysis treatments upon prescription by a
physician. Patient counselling and teaching of treatment techniques are
directly under the supervision and discretion of the physician.
The AK 200 S System comprises of two monitors; one blood monitor

(BM 200 or BM 202) and one fluid monitor (FM 202). The monitors 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 be performed with one pump
(double clamp function) or with two pumps (BM 202 only). To prevent
coagulation, anticoagulantia may be administered by means of a heparin
pump.
The fluid monitor is designed to produce the dialysis fluid at a desired

temperature, conductivity and pressure within given specifications, and
to supervise the dialysis fluid. Both acetate and bicarbonate treatments
can be performed.
CAUTION
Patient education, counselling, home care follow-up and medical
maintenance must be performed under the direction of and
supervision by the physician prescribing the treatment. Gambro
specifically denies any responsibility for patient education,
counselling or home care and medical maintenance.
When AK 200 S is used to produce bicarbonate containing dialysis

fluid originating from non-liquid concentrates, the AK 200 S is
designed and validated for use with the Gambro BiCart® system.
When AK 200 S is used to produce sodium chloride containing
dialysis fluid originating from non-liquid concentrates, the AK 200 S
is designed and validated for use with the Gambro BiCart Select®
system, i.e. the SelectCart® cartridge and SelectBag® concentrate.
Gambro does not accept responsibility for use of other non-liquid
concentrate containers.
CAUTION
Safety philosophy
The AK 200 S is designed according to the current standards for
hemodialysis equipment, IEC 60601-2-16. This means that safety under
so-called Single Fault Conditions is granted. In practice this means that
controllable treatment parameters (i.e. conductivity, temperature and
ultrafiltration) are controlled by one system, the control system, and
monitored by another completely separate protective system, utilizing its
own sensors, electrical circuits and microprocessors. The functionality of
the protective system is checked by the AK 200 S before each treatment.
A fault detection during the pre-treatment tests will make it impossible to
start the treatment.
In order to verify that the corresponding control and protective systems

are operating with the correct input values, the user is instructed to
compare the readings of the current bargraph display and the information
display, before connecting the patient. The bargraph displays show the
set value, the actual value and the alarm limits for the control system,
while the information display shows the corresponding values from the
protective system. If these comparisons are not satisfactory, call your
service technician.
The protective system will, when a parameter (measured by the protective

system) is outside the alarm limits, put the AK 200 S into a patient-safe
condition. This means that the protective system can stop the blood
pump, close the venous clamp, prevent the dialysis fluid from reaching
the dialyzer and alert the operator with sound and light.
The ultrafiltration control system, the UF-cell, control the ultrafiltration

volume with an accuracy corresponding to ± 50 ml x passed treatment
time (h) or ±2,5%. If the accumulated UF volume, measured by the
UF-cell, differs more than 200 ml from the expected volume the machine
issues an attention. In addition to this system there are independent
ultrafiltration measuring systems, protective systems, as described below.
In AK 200 S an independent ultrafiltration measuring system based on

restrictor flow measurement (FRN) is used as protective system for the
UF-volume. For further description, see chapter 3. It is automatically
checked before each treatment and a failure will make it impossible to
start the treatment.
The default alarm limit is set to 800 ml. The accuracy of the system is
±120 ml/h. This means that for a four hour treatment the maximum
weight deviation without any alarm issued is less than 1280 g (800 + 4
x 120). As an additional precaution it is recommended that competent
personnel supervise the patient and that the blood pressure is checked
regularly.
This protective system can be disabled via a preset. If this is done the
remaining supervision is based on the transmembrane pressure, see
further below for description of this system.
As an extra precaution there is also a system for supervision of the
UF-rate. This system is available on condition that the FRN system is
not disabled. The UF rate supervision is using the FRN system and the
measured UF rate is supervised against a limit. This limit constitutes the
maximum allowed deviation between the UF rate measured by FRN and
the UF rate measured by the UF cell over a period of 2 minutes. The
default limit is set to 5 ml/min. The accuracy of the system is ± 2 ml/min.
If this limit, i.e. 5 ml/min, is violated the system initiates a taration of
the UF measuring system. If the limit is violated more than four times
during 30 minutes, the machine terminates the treatment and a technical
error is issued.
In addition, an independent ultrafiltration measuring system based on

the transmembrane pressure is used as protective system. Alarm limits
for TMP related to the dialyzer UF coefficient and the expected UF
rate, are to be set around the actual TMP value when starting treatment.
The TMP alarm limit correspond to a UF-deviation limit described by
TMPAlarm limit x UFcoefficient. Example: If the alarm window is set to ±50
mmHg and the UF-coefficient is 10 ml/mmHg x h the maximum weight
deviations without any alarm is ±500 g/h. Default the alarm window is
set to ±100 mmHg. It is essential to ensure that the alarm window is set
as close as possible to the working TMP. As an additional precaution it is
recommended that competent personnel supervise the patient and that
the blood pressure is checked regularly.
The composition of the dialysis fluid is supervised by the protective

system using an independent conductivity measuring system. The dialysis
fluid conductivity and temperature systems are automatically checked
before each treatment. A failure will make it impossible to start the
treatment.
To protect the patient against a hazardous blood loss to the environment

the AK 200 S incorporates a venous pressure monitoring system. This
system will react upon a change in the venous pressure, i.e when the
pressure falls below the low alarm limit. It must be observed that under
certain pressure/flow conditions a blood loss to the environment may
not be able to cause the venous pressure to fall below the low alarm limit.
To avoid blood loss to the environment it is essential to ensure that all
connections in the extracorporeal blood circuit are tight and secured, that
the fistula needle is correctly positioned and secured and that the low
alarm limit is set as close as possible to the working venous pressure. A
visual monitoring by the user/operator is recommended.
The venous, arterial and system pressure measuring system is checked

automatically at positive, atmospheric and negative pressure before each
treatment. A failure will make it impossible to start the treatment.
The supervision of the stop time of the blood pump is the protection
system against patient blood loss due to coagulation during treatment.
The operator will be notified via an attention alarm that the blood pump
stop time has been exceeded.
The blood leak detector system, which utilizes an optical sensor, is
automatically tested before each treatment for being able to detect
transparency (no blood) and non-transparency (blood). If the system
cannot detect these states, it is impossible to start the treatment.
Furthermore, the system is checked every 5 minutes to ensure that it is
able to detect non-transparency. If not, the system will act as if a blood
leak alarm has occurred and enter a patient safe condition.
The air detector utilizes an ultrasonic sensing system in which the

transmitter is handled by one microprocessor and the receiver by another.
The system is continuously tested for being able to detect an air leakage
condition. If this test is not successful the system will act as if an air
detection has occurred and the machine will enter a patient safe condition.
If the AK 200 S is used to perform Hemodiafiltration, low volume, an

independent substitution flow supervision system is used as protective
system. It is based on restrictor measuring as well as pump speed
measuring. For the restrictor measuring it is essential that a correct
infusion line is used to obtain specified level of safety.
For a more detailed information, please refer to the AK 200 S Service

Manual.
The preparation of dialysis fluid
Inlet water requirements

The chemical and microbiological quality of the water used to prepare
fluids for dialysis is an important factor for achieving and maintaining the
proper quality of the dialysis fluid.
The quality of the water depends on the technical equipment for water
treatment. Further, proper maintenance of the water treatment system
and of the water distribution loop is essential.
The inlet water must comply with valid standards for water for dialysis;
see chapter “Technical data and specifications/Water supply” in this
manual for more details.
Preparation of the dialysis fluid

The AK 200 S prepares dialysis fluid from inlet water and concentrates.
The dialysis fluid should be made from dry concentrates (such as the
BiCart Select® products) or from an acidic (A) concentrate and a dry
bicarbonate concentrate (such as the BiCart® cartridge). It can also
be made from an acidic (A) concentrate and a liquid bicarbonate (B)
concentrate or from an acetate concentrate. See “List of concentrates”
in this chapter.
UFD- Ultrafiltered Dialysis Fluid (option)

The AK 200 S can be equipped with a holder in which an ultrafilter
can be mounted. The ultrafilter purifies the dialysis fluid from possible
contamination by bacteria and endotoxins.
Ultrafilters; frequency of change

The ultrafilter used in Ultrafiltered Dialysis Fluid kit is to be changed
regularly depending on the primary fluid quality and the desired final fluid
quality. The results from microbiological controls have to determine
the frequency of change. A frequency between once a month and once
every three months can be expected.
For instructions on how to change the ultrafilter, see "Ultrafilter; how

to change" in chapter 12.
List of concentrates, accessories and
disposables, for use with the AK 200 S
This manual contains a number of references to concentrates, accessories
and disposables for use with the AK 200 S. For ease of reference, set out
below is a comprehensive listing of such concentrates, accessories and
disposables as follows:
Concentrates
Liquid concentrates Area of use
001-099 series Liquid acetate concentrates for preparation
6xx series of acetate dialysis fluid.
2xx series Liquid A-concentrate for preparation of
7xx series bicarbonate dialysis fluid together with
8xx series BiCart or with bicarbonate hemodialysis
concentrate D 200 (Sodium bicarbonate
8,4 %).
3xx series Liquid A and B concentrates for
preparation of bicarbonate dialysis fluid.
SelectBag® series Liquid A-concentrate for preparation of
bicarbonate dialysis fluid together with
SelectCart and BiCart.
Non-liquid concentrates Area of use
BiCart® Dry bicarbonate concentrate for
preparation of bicarbonate dialysis fluid
together with proper liquid A-concentrate
or SelectCart and SelectBag.
SelectCart ® Dry sodium chloride concentrate for
preparation of bicarbonate dialysis fluid
together with SelectBag and BiCart.
CAUTION
Incorrect choice of dialysis fluid concentrate may cause incorrect
composition of the dialysis fluid.
CAUTION
Lines
Line number Area of use
Gambro Medical Line (PVC+DOP/ EtO sterilized)
BL 10 series Arterial and venous blood line set.

BL 100 series Arterial and venous blood line set.
AV 100 series Arterial and venous blood line set.
A 5000 series Arterial blood lines.
V 5000 series Venous blood lines.
When performing low volume HDF, the venous blood line has to be
equipped with a T/Y-connector.
Gambro Blood Tubing System (PVC+DOA/Beta sterilized)
BL 200 series Arterial and venous blood line set. The

arterial blood line has a cuvette when BVS
is to be used.
When performing low volume HDF, the venous blood line has to be
equipped with a T/Y-connector.
Gambro Accessories
C series Hemodialysis accessories.

C 705 A connection line with an expansion
chamber. Used in single needle/single
pump mode.
C 200 HDF+EC Infusion line used in low volume HDF.
Dialyzers/Ultrafilter
Dialyzer/Ultrafilter Area of use
U 8000 S Ultrafilter used in Ultra Filtered Dialysis
Fluid kit.
Dialyzers Most types of dialyzers, except plate
dialyzers, can be used. However, it is
essential to verify that the specifications
and instructions for use of the dialyzers
are not in discrepancy with those given
for AK 200 S, with regards to e.g. the
recommended priming procedure. The
connectors and the ports of the dialyzer
must comply with ISO 8637 and EN 1283.
Infusion fluid for low volume HDF
Infusion solution Area of use
Hemofiltrasol 2x serie Infusion fluid used for low volume
hemodiafiltration.
Blood pressure measurement accessories

Gambro Cuff Area of use
Standard No. 1 (7 cm) for 12 - 18 cm arm circumference.
Latex free Child for 18 - 26 cm arm circumference.
Latex free Adult for 25 - 35 cm arm circumference.
Latex free Large for 33 - 47 cm arm circumference.
Single hand Child for 17 - 22 cm arm circumference.
Single hand Adult for 22 - 32 cm arm circumference.
Single hand Large for 32 - 42 cm arm circumference.
Gambro Cuff hose

3,5 m Cuff hose used for measuring blood
pressure together with the AK 200 S.
CAUTION
The AK 200 S has been tested and validated for use with the
concentrates, accessories and disposables specified above.
Gambro does not accept any responsibility or liability for use of

concentrates, accessories or disposables other than those specified
above. Depending on the circumstances, use of concentrates,
accessories or disposables other than those specified above may
also reduce Gambro’s warranties for the AK 200 S.
CAUTION
Note
• The user should make sure to have a current listing of concentrates,
accessories and disposables available.
• The user should follow the facility procedures for proper disposal
of used blood lines, dialyzers and other disposables per local
regulations.
Note
List of symbols
Note
• All symbols in this list may not be represented on this product.
Note
Symbol Description
Alternating current
Protective earth (ground)
Warning, consult accompanying

documents
Off (power, disconnection from the mains)
On (power, connection to the mains)
Type B, applied part
Handle with care
This way up
Keep dry
Symbol Description
Input /Output
Year of manufacturing
Heater power supply outlet
Conforms to requirements in EC Council

Directive 93/42/EEC concerning medical
devices. 0086 identifies BSI, British
Standards Institution, as Notified Body.
CSA approved for Canada
CSA approved for Canada and USA
CSA-listed label manufacturer
Prohibited behaviour
Equipotentiality
Separate collection for electrical and

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

describes is CE-marked.
Manufacturer
Gambro Lundia AB, Monitor Division,
Box 10101, SE-220 10 LUND, Sweden.
Phone +46 46 169000.
Copyright
© 2001-2003, 2005 Gambro Lundia AB
Chapter 2
Description - the machine and its

components
Blood monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2:2
BM 200 - Single Pump, BM 202 - Double Pump . . . . . . . . . . . . . . . . . 2:2
Fluid monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2:4
FM 202 - Acetate and Bicarbonate . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2:4
Rear of the machine - without options . . . . . . . . . . . . . . . . . . . . . . . . . . . 2:6
Rear of the machine - options included . . . . . . . . . . . . . . . . . . . . . . . . . . . 2:8
Monitor stand . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2:10
MS 200: Adjustable height: five fixed positions . . . . . . . . . . . . . . . . . . 2:10
MS 202: Electrically adjustable height . . . . . . . . . . . . . . . . . . . . . . . . . 2:12
Program version 8.xx AK 200 S Operator’s manual - Description 2:1
Blood monitor
BM 200 - Single Pump, BM 202 - Double Pump
Figure 2:1 Blood monitor
1. Top tray
To protect the machine against leakage the top tray must always be
placed on top of the machine.
2. Air detector
The air detector head is designed for a drip chamber with a diameter
of 22 mm. The ultrasonic air detector will detect air or foam in the
venous drip chamber.
3. Venous pressure transducer connector
4. Arterial pressure transducer connector

An arterial blood line with a cuvette is required.
6. Arterial blood pump

The blood pump will stop if the pump cover is opened. During
a power failure the pump can be manually operated by use of the
pump handle. It is only possible to turn the arterial blood pump in
an anticlockwise direction.
2:2 AK 200 S Operator’s manual - Description Program version 8.xx
7. Heparin pump
The heparin pump can be programmed for different syringe sizes .
Syringes shall comply with ISO 7886 - 2. Upon delivery the machine
is programmed for a 30 ml Becton Dickinson syringe with a length
of 81,0 mm . Syringes of other volumes and brands can be
programmed.
8. Arterial line guide
9. Priming detector
The priming detector detects if there is blood in the venous blood
line. Before the priming detector detects blood certain alarms are
suppressed to facilitate the priming. Treatment time and accumulation
of values will start when blood has been detected. The treatment time
will continue to count down as long as blood is detected.
10. Arterial and venous line clamps

The clamps close the arterial and venous lines in certain alarm
situations. The clamps are also used when performing single needle
dialysis.
11. Level adjustment buttons

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.
When pressed and hold, the level adjustment buttons are active for
maximum 6 seconds at a time. After this, the buttons need to be
pressed again to further adjust the level.
12. System pressure transducer connector

The system pressure transducer can be used for:
- Predialyzer (post pump) pressure
- System pressure in Single needle double pump
- Flow supervision in HDF treatment
13. Venous blood pump/infusion pump (BM 202 only)

The pump can be used as venous blood pump in hemodialysis single
needle double pump. In low volume hemodiafiltration the pump is
used as infusion pump for substitution fluid. The pump will stop if
the pump cover is opened. During a power failure the pump can be
manually operated by use of the pump handle. It is only possible to
turn the venous blood pump/infusion pump in a clockwise direction.
14. Expansion chamber holder
15. Operator’s panel
Fluid monitor
FM 202 - Acetate and Bicarbonate
Figure 2:2 Fluid monitor
1. Disinfection ports for concentrate pick-up tubes
2. B pick-up tube marked blue-white

The B pick-up tube is used for intake of:
- Bicarbonate concentrate
- Acetate concentrate
- Concentrated or diluted disinfectants
3. A pick-up tube marked red

The A pick-up tube is used for intake of acidic concentrate.
4. Dialysis fluid outlet (to dialyzer)
5. Dialysis fluid inlet (from dialyzer)
6. Safety coupling
7. Turnable dialyzer holder arm
8. Blood leak detector
9. SelectBag holder
The machine is designed for use with the Gambro SelectBag®, a bag
containing electrolytes (except sodium chloride).
10. SelectCart holder

The machine is designed for use with the Gambro SelectCart®, a
cartridge containing dry sodium chloride.
11. BiCart holder

The machine is designed to be used with Gambro’s BiCart® System,
a cartridge containing dry bicarbonate powder. During disinfection
mode, also used as a holder for CleanCart-C or CleanCart-A,
cartridges containing a cleaning agent.
Rear of the machine - without options
Figure 2:3 Rear of the machine - without options
1. BPM (Blood Pressure Monitor) connection

The line to the optional blood pressure cuff is connected to the nipple.
2. Potential equalization connection

This connection is used for the potential equalization conductor.
When a central venous catheter is used, the conductor must be
connected to minimize the risk of electric shock. The connection is
marked with the symbol for equipotentiality (see “List of symbols”
in this manual).
3. Relay interface connection, marked yellow
4. GSS / PC connection, marked black
5. Optional connection, marked grey
6. UF calibration unit connection, marked blue
7. Mains supply inlet
8. Main switch
9. Fuses
10. Power supply unit
11. Halt button

When the button is pressed the power supply to the AK 200 S is
interrupted. As soon as the button is released the power returns and
the machine performs a recovery.
12. Charging indicator
13. Drain outlet - from the machine
14. Water inlet
15. Heating vessel overflow
Rear of the machine - options included
Figure 2:4 Rear of the machine, options included
1. BPM (Blood Pressure Monitor) connection

The line to the optional blood pressure cuff is connected to the nipple.
2. Potential equalization connection

This connection is used for the potential equalization conductor.
When a central venous catheter is used, the conductor must be
connected to minimize the risk of electric shock. The connection is
marked with the symbol for equipotentiality (see “List of symbols”
in this manual).
3. Relay interface connection, marked yellow
4. GSS / PC connection, marked black
5. Optional connection, marked grey
6. UF calibration unit connection, marked blue
7. Mains supply inlet
8. Main switch
9. Fuses
10. Power supply unit
11. Halt button

When the button is pressed the power supply to the AK 200 S is
interrupted. As soon as the button is released the power returns and
the machine performs a recovery.
12. Dialysis fluid filter (option)
13. Latch for filter change (option)
14. Drain air gap (option)
15. Charging indicator
16. Water inlet
17. Heating vessel overflow
18. Drain outlet - from the machine
19. Air gap (option)
20. Holder for the blood pressure measurement cuff (option)
Monitor stand
MS 200: Adjustable height: five fixed positions
Figure 2:5 Monitor stand, 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 is safely lifted, both on the right and
left hand side of the machine.
5. Screws
For locking the handle (service frame).
6. Screws (rear side)

For height adjustment in five fixed positions.
7. Tray for concentrate containers
8. Lockable wheels
The wheels must be locked during treatment. During internal
transportation the AK 200 S must be in upright position.
MS 202: Electrically adjustable height
Figure 2:6 Monitor stand, electrically adjustable
1. Infusion pole
The maximum allowed load is 10 kg.
2. Height adjustment for infusion pole
3. Rear handle
4. Bars, lifting positions

Positions where the AK 200 S is safely lifted, both on the right and
left hand side of the machine.
5. Screws
For locking the handle (service frame).
6. Control for height adjustment
7. Power supply cord

For height adjustable stand only.
8. Tray for concentrate containers
9. Lockable wheels
The wheels must be locked during treatment. During internal
transportation the AK 200 S must be in upright position.
This page is intentionally left blank
Chapter 3
Controlling the machine - general

guidelines
Operator’s panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:2
Hygiene group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:4
Mode group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:5
Concentrate stand-by mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:6
Procedure for manual activation . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:7
Resume fluid preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:7
Therapy group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:9
Treatment overview group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:10
Bargraph display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:10
Flow diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:10
Time display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:11
Parameter buttons and their displays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:12
Reset possibilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:16
Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:17
Alarm indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:17
Alarm function of the parameter buttons . . . . . . . . . . . . . . . . . . . . . . . 3:18
Override possibilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:20
Stand-by group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:22
Display and setting group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:23
Information display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:23
Treatment overview screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:24
Parameters shown on Treatment overview screen . . . . . . . . . . . . . . . . 3:25
Function check overview screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:26
Tests shown on Function check overview screen . . . . . . . . . . . . . . . . . 3:27
The eight commandments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:28
Setting of parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:29
Downloading treatment parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:32
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:33
The ultrafiltration control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:34
Protective system for ultrafiltration . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:35
Power failure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:38
Returning the blood during a power failure . . . . . . . . . . . . . . . . . . . . . 3:38
Battery back-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:38
Recovery from a short power failure . . . . . . . . . . . . . . . . . . . . . . . . . . 3:39
Recirculation during treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:40
Reconnection of the patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:40
Change of blood pump segment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:42
BiCart/SelectCart change during treatment . . . . . . . . . . . . . . . . . . . . . . . . 3:43
Program version 8.xx AK 200 S Operator’s manual - Controlling 3:1
Operator’s panel
Both the blood monitor and the fluid monitor are controlled and
supervised from the operator’s panel. The panel consists of a number of
buttons, bargraph displays, flow paths, a time display, an information
display, a blood flow knob and one set knob.
The panel is divided into 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.
4. Treatment overview group

This group graphically shows the status of the treatment and allows for a
complete overview of all important treatment parameters.
4.1. Bargraph display
4.2. Flow diagram
4.3. Time display
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.
6.1. Information display
6.2. Blood flow knob
6.3. Set knob
3:2 AK 200 S Operator’s manual - Controlling Program version 8.xx
6.3
6.1
6
6.2
5
4
4.3
3
4.2
4.1
4
AK 200 S
2
1
EN1034
Figure 3:1 Operator’s panel
Hygiene group
The ON/OFF button is used to switch the machine on and off. (The
main switch on the back of the machine should always be in the ON
position even when the machine is not in use). It is only possible to
turn the machine off when time is 0.00 and no blood is detected by the
priming detector.
The Chem disinf button is used to select chemical disinfection mode. The
AK 200 S can be turned off by pressing the ON/OFF button, as soon as
the fill phase is completed.
The Heat disinf button is used to select heat disinfection mode (heat
disinfection alone or in combination with a citric acid or CleanCart
disinfection).
The Rinse/Drain button is used to select rinsing (rinsing alone or in

combination with CleanCart) and draining mode.
Rinse/drain, heat disinfection and chemical disinfection cannot be

selected during treatment.
The Auto Heat button is used to activate the possibility to start a Heat
disinfection program at a predetermined time. See "Automatic start of
Heat disinfection program" in chapter 12.
The Auto Rinse button is used to activate the possibility to start a

Rinse/Drain program at a predetermined time. See "Automatic start of
Rinse/Drain program" in chapter 12.
Note
• The above mentioned buttons must be pressed for at least 3 seconds
in order to activate/deactivate the functions.
Note
Mode group
The Isol UF button is used to select isolated ultrafiltration (sequential
dialysis).
The SN button is used to select single needle treatment.

Single needle treatment can be performed with one blood pump or with
two blood pumps (BM 202 only).
Function not available.
The Acetate button is used to select acetate treatment and type of

concentrate .
The lit Acetate button can be pressed twice in order to activate Concentrate
stand-by mode after the machine has passed the function check and
the bypass path on the flow diagram has lit up green (this cannot be
done if blood has been detected). This means that the machine enters a
stand-by mode where the consumption of concentrates will be stopped.
For further information see “Concentrate stand-by mode” further on
in this section.
The Volume control button lights up to show that the machine runs with
controlled ultrafiltration.
The Bicarbonate button is used to select bicarbonate treatment and type of

concentrate .
The lit Bicarbonate button can be pressed twice in order to activate
Concentrate stand-by mode after the machine has passed the function
check and the bypass path on the flow diagram has lit up green (this
cannot be done if blood has been detected). This means that the machine
enters a stand-by mode where the consumption of concentrates will be
stopped. For further information see “Concentrate stand-by mode”
further on in this section.
The lit Bicarbonate button is also to be pressed twice in order to drain
remaining fluid from the SelectBag, the SelectCart cartridge and the BiCart
cartridge when treatment has been discontinued. See “Discontinuing” in
corresponding chapter for the treatment mode performed.
Note
Note
Concentrate stand-by mode
When the machine has been switched on, has passed the function check
with proper concentrates connected, and the bypass path on the flow
diagram lights up green, it is possible for the machine to enter a stand-by
mode where the consumption of concentrates will be stopped.
This stand-by mode, called Concentrate stand-by mode, can be activated

before or after the flashing Fluid bypass button has been pressed during
priming i.e. before or after the priming of the fluid compartment of the
dialyzer has been performed. (It cannot be activated if blood has been
detected.)
Concentrate stand-by mode can be manually activated by twice pressing

the Bicarbonate or Acetate button (default function) or automatically be
activated by preset.
On request from the clinic, an authorized technician can preset the type
of presets for Concentrate stand-by mode that best suits the routine
procedures of the specific clinic.
There are two presets that can be used, separately or in combination:
1. Automatic activation of Concentrate stand-by mode when time is
shown on the time display and the bypass path of the flow diagram
lights up green. The time for activation may be straight away when
the bypass path lights up green, or for a preset amount of time after.
2. The time for automatic activation can also be preset to be when the
attention alarm
PRIMING VOLUME ACHIEVED

Check line in priming detector
appears during priming.
When the Concentrate stand-by mode is active, the Bicarbonate or

Acetate button will be flashing and there will be a conductivity alarm
without buzzer to indicate this.
When Concentrate stand-by mode is active, the fluid flow is automatically

decreased to 100 ml/min to minimize the water consumption.
Procedure for manual activation
Press the lit Bicarbonate (or Acetate button) twice and this screen will be
shown on the information display:
Figure 3:2 Concentrate stand-by mode, activation
Press the lit Arrow button to activate Concentrate stand-by mode.

When the mode has been activated, the text will change and be replaced
by CONCENTRATE STANDBY MODE ACTIVE.
At the same time the Bicarbonate or Acetate button will start to flash and
there will be a conductivity alarm without buzzer. This will continue
during the period of time when the Concentrate stand-by mode is active.
Resume fluid preparation

The dialysis fluid preparation will resume (Concentrate stand-by mode
deactivated) when the flashing Bicarbonateor Acetate button is pressed once.
The dialysis fluid will be ready within approximately 3 minutes.
If dialysis fluid preparation has not been resumed during priming, it will
automatically be resumed when blood is detected in the priming detector
after treatment start. Dialysis fluid preparation will also automatically be
resumed when Concentrate stand-by mode has been active for more
than one hour.
Therapy group
The Priming button is used to activate priming mode.
The Heparin button is used to select heparinization with the heparin pump.
The Profiling button is used to select automatic variation of sodium,

bicarbonate and ultrafiltration rate.
The HDF button is used to select low volume hemodiafiltration mode

and set infusion parameters.
Note
Note
The Fluid flow button is used to select dialysis fluid flow.
Treatment overview group
Bargraph display
The bargraph displays shows values from the control system in the
machine. There are bargraphs attached to values for venous pressure,
arterial pressure, blood flow, temperature, conductivity, TMP, UF volume
and UF rate. For further information, see corresponding button below
“Parameter buttons and their displays” in this chapter.
The viewing angle of the bargraph displays can be adjusted as follows:
Press the middle Arrow button below the unlit information display and
keep pressed down while adjusting the viewing angle using the Set knob.
When the angle has been adjusted, release the Arrow button.
Flow diagram
The flow diagram shows the status of the blood flow and the dialysis
fluid flow.
1-2 Blood path

The blood path lights up when the priming detector detects blood. When
blood has been detected for 20 seconds the blood path will remain lit
until the treatment is discontinued.
3-4-6-7 Dialyzer path

The dialyzer path is lit when dialysis fluid passes through the dialyzer.
3-5-7 Bypass path

The bypass path is lit when the dialysis fluid manually or automatically
bypass the dialyzer. The machine will automatically bypass the dialyzer
during certain alarm conditions and during self-calibration.
6 Ultrafiltration path
The ultrafiltration path is lit during isolated UF and during fluid bypass.
Figure 3:3 Flow diagram
The flow diagram can be lit in different colours:
1-2 lights off during priming.
1-2 is red when the priming detector detects blood.
3-4-6-7 is green when dialysis fluid is correct and passes through the
dialyzer.
3-5-7 is green when dialysis fluid is correct but the machine performs a
self-calibration.
3-5-7 is green and 6 is yellow during isolated UF or when the dialysis
fluid is bypassed manually.
3-5-7 is orange and 6 is yellow when dialysis fluid is incorrect (could be
wrong conductivity or temperature).
Time display
During function check the time display shows FCH/Fch.
During treatment it shows the remaining treatment time.
During disinfection programs it shows estimated remaining time for the
ongoing program.
Parameter buttons and their displays
Bargraph Information Explanation
display display
Yellow bar VEN PRES Actual value

Red bars LOW HIGH Alarm limits
Double needle mode

Green bar SET Set value
Yellow bar BL FLOW Actual value
ACC VOL Accumulated volume
SEGMENT Blood pump segment diameter
Single needle/single pump mode

Green bar ART FL Set arterial blood flow
Yellow bar MEAN FL Actual mean blood flow
ACC VOL Accumulated volume of blood
treated
SEGMENT Blood pump segment diameter
Single needle/double pump mode (only valid for HD)

Green bar MFL SET Set mean blood flow
Yellow bar MFL/ACC Actual mean blood
flow/Accumulated volume of
blood treated
Red bar Low alarm limit for actual blood
flow
VEN Venous blood flow
ART Arterial blood flow
Single needle/single pump mode

STROKE Actual stroke volume
VEN TME Time for venous phase
ART TME Time for arterial phase
PRESSURE Actual system pressure
Single needle/double pump mode (only valid for HD)

STROKE Actual stroke volume
SET Set stroke volume
PRESSURE Actual system pressure
HIGH High limit for system pressure
display display
Green bar SET Set value

Yellow bar TEMP Actual value
Acetate mode
Green bar SET Calculated conductivity value
Na+ Set value
Yellow bar COND Actual value
Red bars Alarm limits
Flashing red bars Temporarily extended alarm limits
(pH) Actual pH value (optional)
Bicarbonate mode
Green bar SET Calculated conductivity value
Na+ HCO3- Set value
Yellow bar COND Actual value
Red bars Alarm limits
Flashing red bars Temporarily extended alarm limits
(pH) Actual pH value (optional)
Yellow bar ART PRES Actual value

Yellow bar TMP Actual value

Clinic automation
See "Downloading treatment
.....
......
....... parameters" in this chapter for
instructions.
Green bar SET Set UF volume (patient weight loss)

Yellow bar UF VOL Accumulated UF volume (patient
weight loss)
CALC UFR Calculated UF rate
display display
If pressed twice (not valid if the function is removed by preset)

SUPERV UF supervision measured
accumulated UF volume
LOW Lower level for UF supervision
alarm
LIMIT Settable alarm limit for UF
supervision
HIGH Upper level for UF supervision
alarm
Green bar SET Calculated set UF rate (patient

weight loss/h)
Yellow bar UF RATE Actual UF rate (patient weight
loss/h)
PRIMING Priming UF rate (displayed during
priming)
MIN UFR Minimum UF rate during treatment
Red bar UF rate limit
Low volume HDF

Green bar SET Calculated set UF rate (patient
weight loss/h)
Yellow bar UF RATE Actual UF rate (patient weight
loss/h)
PRIMING Priming UF rate (displayed during
priming)
TOTAL Actual total UF rate (filtrate flow
rate/h, displayed during treatment)
MIN UFR Minimum UF rate during treatment
Red bar UF rate limit
SET Heparin set value

ACC Accumulated volume
STOP LIM Stop limit
display display
No display. When the function

check of the blood monitor is
completed, the button is flashing.
The button has to be pressed to
activate priming mode, the button
lights up. The light will go off when
the priming detector has detected
blood.
NOTE:
The dialysis fluid tubings must
remain connected to the safety
coupling during the complete
function check.
Profiling capability of Na+, HCO3-

and UF (see chapter 7).
Low volume HDF

INFUSION Accumulated infusion volume
PRIMING Accumulated priming volume
(displayed during priming)
BOLUS Accumulated extra infusion volume
(displayed during treatment)
SET Set total infusion volume
PRIMING Set priming volume (displayed
during priming)
BOLUS Set extra infusion volume (displayed
during treatment)
DIA FLOW Actual Dialysis fluid flow

ACC VOL Accumulated Dialysis fluid flow
SET Set value
HIGH Max set value
The TIME-display always shows

the REMAINING time (h.min)
REMAIN Remaining treatment time
PASSED Passed treatment time
NON DIFF Passed treatment time without
diffusion
display display
The BPM measures blood pressure

and pulse rate. See the BPM
chapter for activation and settings.
The BVS measures relative blood

volume. See the BVS chapter for
activation and settings.
The Diascan measures clearance,

Kt and Kt/V. See the Diascan
chapter for activation and settings.
Reset possibilities
The accumulated values for Blood flow, Time, UF volume, UF volume
supervision, Dialysis fluid flow, Heparin as well as Infusion volume
together with priming and bolus volumes can be reset to 0 by pressing
the Time button for 15 seconds when no blood is detected. Note that the
remaining time as well as the passed treatment time and treatment time
without diffusion will be reset to 0.
Alarms
Alarm indicators
The alarm indicators will light up in certain alarm situations. The
Mute button will flash and the buzzer will sound. By pressing a lit alarm
indicator it is possible to obtain further information on the information
display.
Air detector alarm

Steady light indicates that air is detected in the venous drip chamber. A
flashing button indicates that the fault has been rectified. In order to reset
the alarm, the button must be pressed. See "Alarm list" in chapter 14
of this manual.
BVS
Steady light indicates that the blood volume has decreased below the set
alarm limit. Press the BVS button followed by the left Arrow button, turn
the Set knob in order to change the alarm limit.
Attention alarm
Steady light indicates that attention from the operator is required.
The button has to be pressed in order to get further information or
instructions on the information display. A small arrow in the right corner
of the information display indicates more than one attention. The next
attention will be displayed when the button is pressed again.
Technical alarm
Flashing light indicates that there is a technical fault. Press the button
for further information. If necessary call for your service technician.
A small arrow in the right corner of the information display indicates
more information. The next information will be displayed when the right
Arrow button (HIGH) is pressed.
Blood leak alarm

Steady light indicates that blood has been detected in the dialysis fluid
after the dialyzer. A flashing button indicates that the fault has been
rectified. In order to reset the alarm, the button must be pressed.
pH alarm (option)
Steady light indicates that the pH of the dialysis fluid/substitution fluid is
outside the limits. The alarm limits can be changed in alarm situations.
Alarm function of the parameter buttons
Certain parameter buttons also serve as alarm indicators for the
corresponding parameters. The parameter button/alarm indicator will
light up in alarm situations. In addition, the Mute button blinks and the
buzzer sounds.
Venous pressure alarm

Steady light
The venous pressure is outside the set limits.
Centralizing alarm
Flashing light
The venous pressure limits are too wide, or the low venous pressure
alarm limit is below +10 mmHg.
Blood flow rate alarm (single needle/double pump mode only)

Steady light
The actual mean blood flow rate is too low, default: 70% of set value .
Temperature alarm
Steady light
The temperature of the dialysis fluid is outside the set limits.
Conductivity alarm
Steady light
The conductivity of the dialysis fluid is outside the limits.
Arterial pressure alarm

Steady light
The arterial pressure is outside the set limits.
Centralizing alarm
Flashing light
The arterial pressure limits are too wide.
Transmembrane pressure alarm

Steady light
The transmembrane pressure is outside the set limits.
Centralizing alarm
Flashing light
The transmembrane pressure limits are too wide.
UF volume alarm
Steady light
The UF volume is outside its limits, see attention list chapter 14.
Time attention alarm
Flashing light
The treatment time has expired.
BPM attention alarm

Flashing light.
See attention message.
Diascan attention alarm

Flashing light.
See attention message.
Override possibilities
It is possible to override (bypass) the alarm actions for low venous
pressure, arterial pressure, air detector and blood leak alarms for a limited
amount of time . The purpose of the override option is to facilitate the
handling of the machine in alarm situations.
Activate the override function by pressing the lit alarm indicator for 3
seconds. It is possible to override the alarm actions for more than one
alarm at the same time, in this case, press each alarm indicator separately.
The buzzer will still sound during the override time but can be silenced
by the Mute button being pressed. If the cause of the alarm has not been
corrected within the override time, the alarm actions will automatically
recur.
For information concerning machine alarm actions for each alarm, see
Alarm list in chapter 14.
Arterial pressure alarm override

Press the lit Arterial pressure button for 3 seconds; the blood pump will now
run with the set blood flow rate and the venous clamp will be open. This
will continue for 15 seconds . If necessary, it is always possible to stop
the blood pump by pressing the Blood pump button. When the override
time has passed and if the alarm is still active, the arterial pressure alarm
actions will automatically recur.
Low venous pressure alarm override

Press the lit Venous pressure button for 3 seconds; the blood pump will now
run with the set blood flow rate and the venous clamp will be open. This
will continue for 15 seconds . If necessary, it is always possible to stop
the blood pump by pressing the Blood pump button. When the override
time has passed and if the alarm is still active, the low venous pressure
alarm actions will automatically recur.
Air detector alarm override

Press the lit Air detect button for 3 seconds; the blood pump will now
run at 100 ml/min (in single needle/double pump mode, the venous
pump will run at approximately 100 ml/min) and the venous clamp will
continue to be closed. Adjust the level in the venous drip chamber by
using the level adjustment buttons while the blood pump is running. If
a low venous pressure alarm is simultaneously present, the blood pump
will still be running. The blood pump will run for 15 seconds . If
necessary, it is always possible to stop the blood pump by pressing the
Blood pump button. When the override time has passed, the air detector
alarm actions will automatically recur. When the fault has been rectified,
the flashing Air detect button must be pressed in order to reset the alarm.
Note
• The blood flow rate has automatically been decreased when the air
detector alarm override was activated. Remember to adjust this to
the proper value for the ongoing treatment.
Note
Blood leak alarm override
Press the lit Blood leak button for 3 seconds; the blood pump will now run
with the set blood flow rate and the venous and arterial clamps will be
open. The dialysis fluid will not be bypassed, the UF rate will be set to
minimum UF rate. This will continue for 15 seconds . If necessary, it is
always possible to stop the blood pump by pressing the Blood pump button.
When the override time has passed, the blood leak alarm actions will
automatically recur. When the fault has been rectified, the flashing
Blood leak button must be pressed in order to reset the alarm.
WARNING
When entering an override mode it is essential to remember that the
machine does not monitor that specific parameter. The operator is
responsible for the monitoring during the override time.
WARNING
Stand-by group
The Blood pump button is used to start and stop the blood pump at the
selected flow rate. The button can show a constant light, a flashing light
or no light at all.
Constant light - the blood pump is activated.
Flashing light - the blood pump is stopped and the selected blood flow
rate is more than 0 ml/min.
Light off - the blood pump is stopped and the selected blood flow rate is
0 ml/min or priming has not been activated. When the blood pump is
stopped the venous clamp automatically closes.
Pressing the Blood pump button during treatment will automatically widen
the venous pressure, arterial pressure and TMP alarm windows (flashing
buttons). To centralize the alarm limits around the actual values, press
the respective flashing button (see chapter 4). The maximum permitted
stop time for the blood pump during treatment is 3 minutes . When
this time has expired an attention alarm will be activated instructing the
operator to restart the pump.
Note
• Emergency - Stop
The blood pump can in all situations be manually stopped by
pressing the Blood pump button and the venous clamp closes.
Note
The Mute button is used to silence the buzzer for varying times depending
on the alarm. The mute times for the different alarms are shown in the
alarm and the attention lists (see chapter 14).
There are two buzzer sounds:
• Soft: for attention alarms: – – – – – – – – – –
• Continuous: for all other alarms: –––––––––––
The Fluid bypass button is used to manually bypass the dialysis fluid from
the dialyzer. If the button is pressed when the dialysis fluid has the
desired temperature and conductivity the button will flash. When the
Fluid bypass button has flashed for 5 min. during treatment an attention
alarm will be activated.
The Start UF Stop button is used to start and stop ultrafiltration. When
the priming detector has detected blood, the treatment time will start
counting down and the following parameters will start to accumulate:
treated blood volume, heparin volume, passed treatment time, and UF
volume. The ultrafiltration will start when the Start UF Stop button is
pressed. Pressing Start UF Stop button during treatment will decrease the
ultrafiltration rate to the set minimum UF rate. The TMP alarm window
will automatically widen and the TMP button starts to flash. To centralize
the alarm limits around the actual value, press the flashing TMP button
(see chapter 4 or 5). The permitted stop time is 5 min. When this time
is expired, an attention alarm will be activated instructing the operator
to restart the ultrafiltration.
Display and setting group
Information display
The information display, as the name implies, is used to give the operator
further information. In order to obtain information on the display, an
appropriate button has to be pressed. The information is then shown
for 15 seconds .
If the operator wishes to turn off the display earlier the Hold button can be
pressed and then be pressed a second time to turn off the screen.
The Arrow buttons below the information display light up in order to show
which of the displayed values that are adjustable. If a lit Arrow button is
pressed, the text above the value will flash and the value can be changed
using the Set knob. It is sometimes possible to press two Arrow buttons
at the same time, for example to move low and high alarm limits
simultaneously.
In some attention messages the operator is instructed to confirm an
action by pressing a lit Arrow button.
In these cases the Arrow buttons are referred to as:
Left = LOW
Middle = SET
Right = HIGH
The Hold button is used to hold the information on the information

display. When the Hold button is lit, the Set knob is disconnected. If the lit
Hold button is pressed a second time the display turns off.
If a parameter button is pressed when the Hold button is lit the information
display changes and the hold function disappears.
The Set knob is used for setting of all parameters with one exception -
the blood flow.
The Blood flow knob is used to set the blood flow. The Blood flow knob is
directly accessible, i.e. without first having to press a parameter button.
As soon as the knob is turned the information display is lit.
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:
Figure 3:4 Treatment overview screen
Parameters shown on Treatment overview screen
Qb current blood flow rate
Pa current arterial pressure
Pv current venous pressure
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)
SYS systolic blood pressure (BPM)
DIA diastolic blood pressure (BPM)
pulse rate (BPM)
time of latest measurement check (BPM)
K latest measured clearance value (Diascan)

Kt/V latest measured Kt/V value (Diascan)
time of latest measurement check (Diascan)
time to target is estimated to be within the

remaining treatment time set (Diascan)
Function check overview screen
The Function check overview screen will be displayed on the information
display during the function check of the machine. The screen gives the
operator information about how long the function 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 function check. The time in minutes at the bottom
of the screen shows elapsed time of the function check.
If desired, the Function 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 Function check overview

screen:
Figure 3:10 Function check overview screen
Tests shown on Function check overview screen
Fch_BM function check of the blood monitor
Fch_FM function 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
The eight commandments
1. When a blue button is lit, it indicates an activated function.
2. When a red button is lit, it indicates an alarm.
3. When a button flashes, it is a request to press it.
4. The information display only shows information on request.
5. To request information in the display, the appropriate button has

to be pressed.
Figure 3:11 Temp button and the information display
6. Values in the information display, which can be changed, are indicated

by a lit arrow button.
7. When a lit arrow button is pressed, the indicated value can be

changed with the set knob.
8. The blood flow rate is always changed directly with the blood flow
knob.
Setting of parameters
All treatment parameters are set in a similar way.
To illustrate this, a detailed description follows showing how the values

for the Temp (temperature) are changed.
Press the Temp button.
The information display and its buttons show:
Figure 3:13 Temp button and the information display
The set value for the temperature can be changed with the Set knob if the
middle Arrow button is pressed. To indicate that the set value is possible to
change, the text SET on the information display and the green bargraph
on the temperature display will flash. The alarm limits can be changed
either together or separately. If the low or high limit is to be changed,
press the corresponding Arrow button. The limits are changed together
by pressing both left and right Arrow buttons simultaneously. To indicate
the limits that can be changed, the corresponding texts and bargraphs
will flash.
The light of the information display goes out 15 seconds after the Set knob
or the buttons are touched.
It is however, possible to select new information on the information

display by pressing another button before the 15 seconds have passed. If
the values need to be studied in digital form for more than 15 seconds the
Hold button can be pressed. The Set knob is then disconnected. Pressing an
Arrow button will again make a value changeable. It is always possible to
exit the hold function by pressing another button or the Hold button again.
Note
• The bargraphs displays show the set value, the actual value and
the alarm limits for the control system, while the information display
shows the corresponding values of the protective system (see
chapter 1). In order to verify that the control and protective systems
are operating with the correct input values, the user is instructed
to compare the readings of the current bargraph displays and the
information display before connecting the patient.
Note
Venous pressure
The low and high alarm limits can be changed with the Set knob either
together or separately.
Blood flow in single pump mode

The Blood flow knob is directly accessible i.e. without first having to press
the parameter button. In double needle/single pump mode, the blood
flow rate can be changed with the Blood flow knob. In single needle/single
pump mode, the arterial blood flow rate, can be changed with the
Blood flow knob.
Blood flow in single needle/double pump mode

The mean blood flow rate can be changed with the Blood flow knob. The
venous blood flow rate as well as the arterial blood flow rate can be
changed separately, using the Set knob.
In this mode the actual blood flow value is not compensated for as
regards arterial pressure.
Blood pump segment adjustment

Three different blood pump segment diameters can be selected by
pressing the Blood flow button when the blood pump is stopped in double
needle mode. The blood pump segment diameter is changed with the
Set knob (see “Change of blood pump segments” in this chapter).
SN data in single needle/single pump mode

The times for the venous and the arterial phases can be changed with
the Set knob.
SN data in single needle/double pump

The stroke volume and the high system pressure limit can be changed
with the Set knob.
Temperature
The set value, the low and high alarm limits for the temperature can be
changed with the Set knob. When the set value is changed, the alarm
limits will automatically follow. However, the alarm limits can also be
changed separately. See previously in this chapter (Setting of parameters,
Temperature example).
Conductivity in acetate mode

The set value for sodium can be changed with the Set knob. When the set
value is changed, the alarm limits will automatically follow, at 5% of the
resulting set value of the conductivity.
Conductivity in bicarbonate mode
The set values for sodium and bicarbonate can be changed with the
Set knob. When one or both set values are changed, the alarm limits will
automatically follow, at 5% of the resulting set value of the conductivity.
Arterial pressure
The low and high alarm limits can be changed with the Set knob either
together or separately.
TMP
The low and high alarm limits for the transmembrane pressure can be
changed either together or separately using the Set knob.
UF volume
The set value for the total ultrafiltration volume (patient weight loss)
can be changed with the Set knob.
UF rate
The priming UF rate and the minimum UF rate during treatment can be
changed with the Set knob.
Time
The remaining treatment time shown in the TIME-display, can be
changed with the Set knob.
Heparin
The set value for the heparin flow rate and the stop time for the
heparinization (time before treatment ends) can be changed with the
Set knob.
Dialysis fluid flow

The set value for dialysis fluid flow can be changed between the low and
high value, in steps of 25 ml/min, with the Set knob.
BPM (option), BVS and Diascan

The parameter settings for the above mentioned functions are described
in the corresponding chapter for each function.
Downloading treatment parameters
It is possible to download certain treatment parameters from an external
computer system via a patient card or other external equipment.
After the ON/OFF button has been pressed and the first part of the
function check has been completed (“Fch” shown on the time display), it
is possible to download a list of treatment parameters and their values.
The Clinic automation button can be pressed directly after downloading to
view the list, or if desired, reject it.
Once the Priming button starts to flash, the complete list of treatment
parameters can either be accepted (Accept) or rejected (Reject)
by the operator. The list will be displayed on the information display
when the flashing Clinic automation button has been pressed, see figure
3:14. Acceptance/rejection can be done at any time during treatment
preparation until blood has been detected.
Figure 3:14 Downloading treatment parameters
All parameters in the list will be accepted or rejected at the same time, it is
not possible to exclude or add separate parameters or change values in
the list. When the list has been accepted, the values will automatically be
set in the machine (any previously set values will be replaced). If the list
is rejected it is possible to redo the downloading. After the downloaded
list of parameters are accepted or rejected, it is possible to set/adjust
treatment parameters as usual.
Concentrate parameters will be automatically set by the machine after

downloading (before acceptance). The reason for this is not to disturb or
prolong the function check.
If the list of treatment parameters is rejected, the downloaded settings for
concentrates will remain. An attention alarm will appear to remind the
operator about this.
CONC. SETTINGS NO LONGER DEFAULT

Check settings, press LOW
To continue, press the lit Arrow button to confirm the downloaded settings.
Check if the downloaded concentrate settings are the desired ones, if not,
select and connect new concentrates manually, as is the usual procedure.
If any parameter or parameter value in the list is not accepted by the

machine, an attention alarm will appear after downloading. The complete
list of parameters must be rejected.
CAN NOT APPLY DOWNLOADED PARAM.

All parameters must be rejected
Press the Clinic automation button to check which parameter, shown in red,
cannot be set. Redo the downloading after changing the parameter or set
all parameters manually. If this attention alarm occurs, it is important
to note that the downloaded settings for concentrates have not been
automatically set.
Procedure
1. Press the flashing Clinic automation button. A list of the downloaded
treatment parameters will be shown on the information display.
2. Check all the parameter values displayed; scroll down through the
complete list by using the Set knob; the green arrow to the left of the
parameter indicates your current position in the list. All parameters
in the list must be scrolled through. The parameters in the list must
correspond with the prescription. Choose either to accept or reject
the list, then continue to the appropriate point 3 in the instructions
below.
Accept
3. Press the Arrow button below Accept, see figure 3:14. At this
moment, the complete list of treatment parameters will automatically
be set in the machine (any previously set values will be replaced).
During the setting time (about 15 seconds), only the Mute button and
the Blood pump button are accessible. Note that it is not possible for
the machine to display the list of downloaded parameters after the
acceptance has been done. When checking parameters after this, each
parameter must be checked separately by pressing the corresponding
parameter button.
Reject
3. Press the Arrow button below Reject, see figure 3:14. All treatment
parameters shown in the list will now be rejected. Note that the
downloaded concentrate settings will remain.
The ultrafiltration control
During treatment the following equation is always applicable.
Ultrafiltration volume
UF rate
Treatment time
Treatment time and UF volume can be set within certain limits. The
machine will automatically calculate and show the UF rate. When
treatment time or UF volume is changed the UF rate will also change and
new TMP alarm limits have to be set.
An example of how a UF setting is done is shown below.

1. Press the Time button and select the treatment time.
2. Press the UF volume button and select total UF volume. (As soon as
the ”SET” Arrow button is pressed the bar on the UF rate display also
starts to flash, showing the calculated UF rate).
3. When the flashing Start UF Stop button has been pressed (lit up),
the TMP alarm limits must be centralized. Note that the alarm
limits should be set in accordance with the UF rate and dialyzer UF
coefficient.
CAUTION
When negative TMP alarm limits are set, no alarm will indicate
that backfiltration may occur.
CAUTION
An attention alarm may appear if an incorrect combination of settings

is made, e.g. the time is 0.00 and the UF volume is set. The alarm will
disappear as soon as the time is increased sufficiently.
A UF rate limit is automatically calculated and set. The limit is 20%

above the calculated UF rate. This limit is the highest permitted UF rate
during the treatment. If for any reason the UF rate has been too low
during a period of time, the machine will try to compensate for this by
increasing the UF rate up to the UF rate limit.
If it is impossible for the AK 200 S to reach the set UF volume within the
remaining time and current UF rate limit, an attention alarm will be given.
The operator is instructed to change either time or UF volume.
Protective system for ultrafiltration
Upon demands from the clinic the below described function in the
machine can be removed. This preset (i.e. removal of function) is done
by a qualified technician in the clinic. The operator is requested to read
the corresponding information for the ultrafiltration system in section
“Safety philosophy” in chapter 1 in this manual.
The protective system for ultrafiltration, also called the UF supervision

system, measures the accumulated ultrafiltration volume during treatment
independent of the control system mentioned before in this chapter in
section “The ultrafiltration control”.
The protective system will estimate accumulated UF volume throughout

the treatment based on treatment Time and UF volume set when the
treatment is initiated.
This estimated accumulated UF volume will not be shown on the
information display.
When the treatment is running the actual measured accumulated UF
volume (SUPERV) will be compared with the estimated accumulated UF
volume at all times during treatment.
If the deviation between these values is more than a certain set limit
(LIMIT) an attention alarm is generated to notify the operator of this, the
ultrafiltration is stopped and the blood flow is decreased. The attention
alarm is shown on the information display as below:
UF VOLUME DEVIATION
Check cause, press UF volume
Check the machine for visual leakage.

Check accumulated UF volume in both control and protective system.
Check alarm limits for UF volume in protective system.
Do customary patient checks as whenever the ultrafiltration volume is
suspected to be incorrect.
Evaluate if it is possible to continue the treatment.
The attention alarm is confirmed by pressing the UF volume button for 3
seconds.
If the attention alarm is confirmed, the machine will recalculate a new
estimated accumulated UF volume, based on the remaining treatment
Time and the remaining UF volume and the ultrafiltration will start again.
Note that every time the attention alarm is confirmed, the deviation
accepted will be added to the previous accepted deviation. Therefore it
is not necessary to adjust LIMIT after an attention alarm. If problem
remains call for technical service.
CAUTION
Incorrect weight loss may occur if confirmation is done without
having corrected the technical cause for the attention alarm.
CAUTION
LIMIT is the alarm limit for the deviation between the estimated
accumulated UF volume and the actual measured accumulated UF
volume (SUPERV). LIMIT is settable by the operator between 0.1 and
2.0 litres of accumulated ultrafiltration volume. The limit must be
set by the operator according to the patients needs and tolerance and
according to the routines of the clinic.
The alarm limits HIGH and LOW will automatically be set by the machine
equally around the estimated accumulated UF volume, i.e. if LIMIT is
set to 0.4 the deviation between HIGH and LOW will be 0.8.
Note
• The lower limit for LIMIT in the machine is 0.1 litre multiplied with
treatment time.
I.e. if LIMIT is set to 0.4 by the operator at the beginning of the
treatment the machine will after 4 hours of treatment start to increase
LIMIT with 0.1 litres per hour.
Note
To view and set the parameters of protective system UF supervision:
1. Press the UF volume button, this will display the UF volume settings.
2. Press the UF volume button again while the UF settings display is active.
The protective system UF supervision parameters are now displayed.
SUPERV - UF supervision measured accumulated UF volume
LOW - Lower level for UF supervision alarm
LIMIT - Settable alarm limit for UF supervision
HIGH - Upper level for UF supervision alarm
3. The settable part of the alarm limit (LIMIT) can be adjusted by

pressing the lit Arrow button below LIMIT followed by turning
the Set knob. This will affect the LOW and HIGH limits which are
automatically set according to LIMIT.
Power failure
Returning the blood during a power failure

If the AK 200 S is not equipped with a battery back-up function, it is
possible to manually return the blood to the patient during a power failure.
1. Clamp the arterial blood line and disconnect it from the patient.
2. Connect the arterial blood line to the rinse-back solution and

unclamp it.
3. Open the cover of the blood pump and turn the blood pump
manually in an anticlockwise direction. Be careful with the guiding
pins so that they do not interfere with the pump segment.
4. When the required amount of blood has been returned to the patient,
clamp the venous blood line and disconnect it from the patient.
When the power returns, the treatment settings and accumulated values
can be read off as usual.
WARNING
During manual procedure to return blood to patient in power failure,
the operator assumes responsibility for visually monitoring all safety
parameters which the machine can not monitor in a power failure
(e.g. air detection).
WARNING
Battery back-up
The AK 200 S can be equipped with a battery back-up function. The
battery acts as a power supply in the event of a power failure. If this
happens, an attention alarm simultaneously appears:
POWER FAILURE, BATTERY OPERATION

Battery operated for X minutes
The battery supplies the AK 200 S with power to all functions except for
that of heating the dialysis fluid. This means that a low temperature alarm
will occur within a minute after the power failure has occurred. When the
power in the battery has been consumed, the machine acts in the same
way as it would with no battery back-up function.
All instructions for installation and replacement of the battery back-up

are included in the AK 200 S Service Manual, Installation Guide.
Recovery from a short power failure
In case of a power failure, settings and accumulated values are stored by
the AK 200 S. The machine will perform a recovery when the power
returns; ”rec” is shown on the time display and the buzzer sounds. The
operator must check the extracorporeal circuit for possible blood clots
and has to confirm continued treatment by pressing the Time button. It is
also necessary to press the Blood leak and Air detector alarm indicators.
1. Press the Mute button to silence the buzzer when the power has
returned.
2. Press the Attention button to read the messages.
3. Press the Time button to confirm the recovery.
4. Press the flashing Air detector button and the flashing Blood leak button.
5. If no heparin values were set, press the Heparin button to confirm

no heparinization.
The AK 200 S will continue the treatment from where it was interrupted.
However, if the AK 200 S has made ten recoveries during the same
working session, the eleventh power failure will result in a function check.
CAUTION
Check treatment parameters after a recovery.
CAUTION
Note
• The recovery function will not store the new settings in case of a
power failure during the function check.
• The AK 200 S is equipped with a battery to support the buzzer

during power failure. During power failures when the buzzer is
muted, the current consumption from the battery is high. In
order to avoid this high consumption, switch the machine off by
pressing the ON/OFF button for 3 seconds instead of pressing the
Mute button. When the power returns, switch it on again by using
the ON/OFF button. A normal recovery (see above) will now follow.
Note
Recirculation during treatment
When the blood circuit is recirculated it is the operator’s responsibility to
decide for how long a period it can be safely done.
The operator should also remember to note the time for the recirculation
in order to add it to the non-diffusion time at the end of the treatment.
1. Stop the ultrafiltration by pressing the Start UF Stop button. The

button will start to flash and the ultrafiltration decreases to the
minimum ultrafiltration rate.
2. Check that the minimum ultrafiltration rate is set according to the

package insert for the dialyzer.
3. Set the blood flow to 100 ml/min.
4. Stop the blood pump.
5. Disconnect the arterial and venous blood line from the patient and
connect them to a connection line.
6. Start the blood pump.
7. Connect a saline bag to the venous drip chamber with help of an

infusion line. Raise the infusion pole to 0.5-1 meter above the venous
drip chamber in order to keep the venous pressure above zero. Open
the clamp on the infusion line from the saline bag.
8. Press the flashing Arterial pressure, Venous pressure and TMP buttons to
set the alarm limits around current pressures.
9. After 5 minutes of bypass of the ultrafiltration an attention is given:
TREATMENT STOP TIME EXPIRED

Press START UF key
Press the Start UF Stop button to restart the ultrafiltration. Press the
Start UF Stop button a second time to stop the ultrafiltration again.
10. When the Start UF Stop button is pressed the TMP button starts to
flash and the alarm limits widens. Press the flashing TMP button to
set the alarm limits.
Reconnection of the patient

1. Close the clamp on the infusion line from the saline bag and stop
the blood pump.
2. Check and remove any air bubbles from the blood lines.
Disconnect the arterial and venous blood line from the connection
line.
3. Reconnect the blood lines to the patient and start the blood pump.
Set the required blood flow rate.
4. If required increase the minimum UF rate to the desired set value.
5. If required adjust the UF volume.
6. Press the flashing Start UF Stop button to restart ultrafiltration. Press

the flashing Arterial pressure, Venous pressure and TMP buttons to set the
alarm limits around current pressures.
Change of blood pump segment
AK 200 S can be used with 3 presettable diameters of blood pump
segments.
Change of blood pump segment should be done before the patient is

connected.
CAUTION
Make sure a correct blood pump rotor is used. The blood pump
rotor has to be properly adjusted in order to correctly occlude the
blood pump segment being used. This is important in order to
achieve the correct blood flow. Check with the service technician
responsible.
CAUTION
AK 200 S has to be in double needle mode and the blood pump has
to be stopped in order for the diameter of the blood pump segment to
be changed.
1. Press the Blood flow button.
2. Press the Arrow button below SEGMENT.
3. Select the appropriate blood pump segment diameter by using the

Set knob.
4. Make sure to use a correct blood pump rotor. The blood pump rotor
has to be properly adjusted in order to correctly occlude the blood
pump segment being used.
5. Confirm the attention:
ADJUST PUMP HEAD TO TUBE x.xx

Press BLOOD FLOW key to confirm
by pressing the Blood flow button.
BiCart/SelectCart change during treatment
If the BiCart and/or the SelectCart cartridge needs to be replaced by new
ones during treatment, do as follows:
1. Remove the cartridge that is to be changed and close both the latches
of the cartridge holder properly (vertical position) for at least 2
seconds. (To close the lower latch; pull out and close.)
2. Open the upper latch of the holder, pull out the latch and lift upwards
to its uppermost position.
3. Open the lower latch of the holder.
4. Place the bottom port of the cartridge into the hole of the lower
latch. Bring down the upper latch and place the top port of the
cartridge into the hole of the upper latch. Press down the upper latch
to puncture the cartridge.
5. The cartridge will now be primed automatically.
When the cartridge has been attached correctly, the priming process
is indicated by a cartridge symbol in the upper right corner of the
The S or the B before the symbol indicates SelectCart or BiCart cartridge.
Figures or letters (0,1,2....A,B,C....) are shown on the cartridge symbol
during the priming process to show the progress of the process.
The cartridge symbol disappears when the priming process is complete.
Chapter 4
Hemodialysis, double needle treatment

Double needle treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:2
Check before starting the machine . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:2
Start the machine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:2
Function check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:3
Select concentrates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:4
Connect concentrates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:6
SelectCart and SelectBag together with BiCart . . . . . . . . . . . . . 4:7
Acidic concentrate and BiCart . . . . . . . . . . . . . . . . . . . . . . . . . . 4:8
Acidic concentrate and liquid bicarbonate concentrate . . . . . . . 4:8
Acetate concentrate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:8
Start the machine - continued . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:9
Attaching the dialyzer and the blood lines . . . . . . . . . . . . . . . . . . . . . . 4:11
Dialyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:11
Preparations if the heparin pump is to be used . . . . . . . . . . . . . 4:14
Priming . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:17
Initiating . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:19
TMP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:22
Discontinuing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:24
Automatic emptying of BiCart, SelectCart and SelectBag . . . . . . . . 4:24
Discontinuing procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:25
Confirm treatment end . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:25
If desired, start emptying BiCart or BiCart, SelectCart and
SelectBag . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:25
Return the blood . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4:25
After-treatment handling of the machine . . . . . . . . . . . . . . . . . . 4:26
Program version 8.xx AK 200 S Operator’s manual - Double needle 4:1
Double needle treatment
Check before starting the machine

• That the mains cable is connected to a mains supply with protective
earth.
• That the main switch on the rear of the machine is turned on.
• That the water supply is turned on.
• That the dialysis fluid tubes are connected to the safety couplings.
• That the drain tube is properly placed with an air gap between the
machine and the drain/sewer system.
CAUTION
In order to protect the operator’s fingers, keep the blood pump
and the clamp covers shut during the function check for the blood
monitor, since the pump(s) as well as the clamps will be tested
during the check.
CAUTION
Note
• If the machine has been stored with chemical disinfectant, this
solution must be rinsed out of the system before any treatment can
be initiated.
Note
Start the machine

The dialyzer and the blood lines may be attached before power on or
when the Priming button is flashing. Follow the instructions further on in
this chapter ”Attaching the dialyzer and the blood lines”.
Follow the six consequent steps below to start the machine.
1. Press the ON/OFF button for 3 seconds.
All the buttons and bargraphs on the operator’s panel are illuminated
simultaneously and the operator is requested to check their functionality
by visual inspection.
If the machine has been filled with a chemical disinfectant the

Chem disinf button will be lit at this moment as well as the Rinse/Drain button.
For further information see “Filling the machine with chemical
disinfectant” in chapter 12.
CAUTION
After Chemical disinfection procedure a test for residues must have
been performed prior to connecting a patient.
CAUTION
4:2 AK 200 S Operator’s manual - Double needle Program version 8.xx
Function check
When the machine starts up it always carries out checks on internal safety
and calibrations; the function check.
FCH/Fch is shown on the time display.
These checks require that the dialysis fluid tubes are connected to the
safety couplings during the entire function check. The dialysis fluid tubes
can be moved from the safety couplings when the time appears on the
time display instead of ”Fch” and the bypass path lights up on the flow
diagram.
These checks also require that no buttons are touched before the first
part of the function check is completed, i.e. when ”FCH” on the time
display has been replaced by ”Fch”.
The Function check overview screen will be displayed on the information

display during this function check. The screen gives the operator
information about how long the function check has been in progress and
also what is being tested at that moment. See “Function check overview
screen” in the “Controlling the machine - general guidelines” chapter for
details.
Note
• If the buzzer sounds continuously and the Attention alarm button
lights up, press the button for information. One of the points below
”Check before starting the machine” has normally been forgotten.
• If the Technical alarm button lights up, there is a technical error. Press
the button for further information. If the information display says:
ERROR! RESTART OR CALL SERVICE
start a new function check, using the ON/OFF button. If the technical
error reoccurs, call your service technician.
• The dialysis fluid tubes must remain connected to the safety coupling
during the complete function check (until preset time is shown in the
TIME display and the dialysis fluid flow path is lit).
Note
Select concentrates
2. Check that the correct treatment mode has been selected; the
corresponding button for Bicarbonate mode or Acetate mode will
be lit.
Press the lit button briefly in order to select/check that the proper
concentrate has been selected on the information display and is in
accordance with the prescribed concentrates that will be connected
to the machine during treatment. The selected alternative will be
flashing.
Figure 4:1 Select Bicarbonate and type of concentrate
The picture above shows the information display when the

Bicarbonate button has been pressed. The concentrate combinations may
vary from clinic to clinic according to patient needs and the routines
of the clinic.
The information display above shows the default values the machine has
been delivered with. It is possible to choose between three combinations
on the information display, preset by the authorised technician in the
clinic.
The selected concentrates are flashing and the corresponding Arrow button
below will not be lit.
When SelectBag is to be used, and is preset as the first alternative on the

information display, it is possible to choose between different SelectBag
concentrations .
The Arrow button below SelectBag will then still be lit indicating that it is
possible to choose different SelectBags.
Press the lit Arrow button.
Figure 4:2 Select SelectBag
The picture above shows the information display when the lit Arrow button
below SelectBag is pressed.
SelectBag will flash and the concentrate below will be lit.
Turn the Set knob until the desired SelectBag is shown.
Press the Arrow button again to confirm the chosen concentrate, both
BiCart and SelectBag will be flashing.
CAUTION
The operator must make sure that the chosen concentrates on the
information display correspond with the connected concentrates
during function check and during treatment.
CAUTION
Connect concentrates
There are four different alternatives for concentrate combinations
described below. Choose the alternative that is to be used.
• SelectCart and SelectBag together with BiCart:

Follow step 3 and 4 in corresponding instruction.
• Acidic concentrate and BiCart:

Follow step 3 and 4 in corresponding instruction.
• Acidic concentrate and liquid bicarbonate concentrate:

Follow step 3 in corresponding instruction. (Step 4 is not valid)
• Acetate concentrate:
Follow step 3 in corresponding instruction. (Step 4 is not valid)
CAUTION
Verify that the correct prescribed concentrate(s) for the specific
treatment is (are) used. Avoid changing concentrate containers
during treatments.
CAUTION
Note
• The concentrate pick-up tubes must be placed in the corresponding
concentrate containers or in the disinfection ports on the machine,
according to table below, otherwise function check will not be
completed.
Placement of pick-up tubes in different treatment modes:
A pick-up tube A pick-up tube in B pick-up tube B pick-up tube in

in concentrate disinfection port in concentrate disinfection port
BiCart Select: x x
Acidic
concentrate and x x
BiCart:
Acidic
concentrate
x x
and liquid
bicarbonate
Acetate x x
Note
SelectCart and SelectBag together with BiCart
Handling procedure:
3. SelectCart: Open the upper latch of the SelectCart holder, pull

out the latch and lift upwards to its uppermost position. Open the
lower latch.
Place the bottom port of the SelectCart cartridge into the hole of the
lower latch. Bring down the upper latch and place the top port of
the cartridge into the hole of the upper latch. Press down the upper
latch to puncture the cartridge.
The SelectCart cartridge will be primed automatically.
SelectBag: Remove the protective foil from the connector port of
the SelectBag.
Open and hold the latch of the SelectBag holder in its uppermost
position while hanging the SelectBag into the holder with the
connector port upwards.
Press down the latch to a horizontal position, whereby the membrane
of the SelectBag is punctured by the spike.
Tap lightly on the SelectBag so that any air bubbles gather at the top.
Figure 4:3 Connect the SelectCart cartridge and the SelectBag
WARNING
Avoid touching the plastic spike.
Be careful to avoid fluid from the SelectBag splashing into your eyes.
WARNING
Note
• Follow the instructions for use of the SelectCart cartridge and the
SelectBag.
• The SelectCart and SelectBag can be attached before or during the

function check. They must have been attached for the function
check to be completed.
• Both concentrate pick-up tubes must be placed in the disinfection

ports of the machine.
Note
4. BiCart: Open the upper latch of the BiCart holder, pull out the latch
and lift upwards to its uppermost position. Open the lower latch.
Place the bottom port of the BiCart cartridge into the hole of the
The BiCart cartridge will be primed automatically.
Note
• Follow the instructions for use of the BiCart cartridge.
• The BiCart cartridge can be attached before, during or after the
function check.
Note
Acidic concentrate and BiCart

Handling procedure:
3. Place the A pick-up tube (marked red) into an acidic container. The
B pick-up tube (marked blue-white) must remain in the disinfection
port.
4. BiCart: Open the upper latch of the BiCart holder, pull out the latch
and lift upwards to its uppermost position. Open the lower latch.
Place the bottom port of the BiCart cartridge into the hole of the
The BiCart cartridge will be primed automatically.
Note
• Follow the instructions for use of the BiCart cartridge.
• The BiCart cartridge can be attached before, during or after the
function check.
Note
Acidic concentrate and liquid bicarbonate concentrate

Handling procedure:
3. Place the A pick-up tube (marked red) into an acidic concentrate

container and the B pick-up tube (marked blue-white) in a liquid
bicarbonate concentrate container.
Acetate concentrate
Handling procedure:
3. Place the B pick-up tube (marked blue-white) into an acetate

concentrate container.
Start the machine - continued
5. Check all set values and alarm limits. Adjust if necessary. Press the
respective button and check/adjust the values on the information
display by using the Arrow buttons and the Set knob.
6. Turn the BVS off if it is not to be used. Press the BVS button followed
by the right Arrow button and turn the Set knob until BVS OFF is
shown on the information display.
Note
• After the machine has passed the function check and the bypass
path on the flow diagram lights up green, it is possible to activate
Concentrate stand-by mode in order to save concentrates before
patient connection. See information in “Concentrate stand-by mode”
in the “Controlling the machine” chapter.
Note
Attaching the dialyzer and the blood lines
When the Priming button is flashing, the dialyzer and the blood lines may
be attached, if this has not been done before power on.
WARNING
The operator must take proper precaution in order to prevent
coagulation in the extracorporeal circuit.
Coagulation may lead to:
• inadequate delivery of dialysis
• risks associated with propagation of blood clots to the patient
• disabling of the air detector function if blood clots aggregate in the
drip chamber
WARNING
CAUTION
To avoid safety hazards, when attaching the blood lines, it is
important to follow the instructions given in the package inserts
for the blood lines and to ensure that the connections are secured
tightly.
CAUTION
Note
• Since tests of the blood pumps and the clamps are included in the
function check, it is important that the blood lines are attached either
before the function check or when the function check for the blood
monitor has been completed (Priming button is flashing).
• The self test of the BVS has to be performed on an empty cuvette

holder, therefore the cuvette has to be outside the holder until
the function check for the blood monitor has been completed
(Priming button is flashing).
• The dialysis fluid tubes must remain connected to the safety coupling
during the complete function check (until preset time is shown in the
TIME display and the dialysis fluid flow path is lit).
Note
Dialyzer
Set up the dialyzer according to the instructions for the specific dialyzer.
Place the dialyzer in the holder.
Arterial blood line
Follow the instructions for the use of the arterial blood line.
Specifically observe the following items.
1. Arterial line clamp - place the patient end of the arterial line in the
line clamp colour-coded with the red dot.
2. Arterial line guide- place the line in the guide.
3. Arterial pressure transducer connector - attach the transducer

protector firmly to the pressure transducer connector.
4. Blood pump - open the cover of the blood pump and place the
pump segment inside the pump housing. The pump segment can be
threaded manually or automatically.
4.a. Manually: Turn the blood pump manually to thread the pump
segment through it. When the pump segment is in place, close
the blood pump cover.
4.b. Automatically: Place the pump segment over the blood pump
rotor and close the blood pump cover.
- If this is done before the machine is switched on, the blood
pump segment will be threaded during function check.
- If this is done during function check (i.e. when “FCH” on
the time display has been replaced by “Fch”), the blood pump
segment will be threaded automatically when Priming is activated
and the Blood pump button has been pressed.
5. BVS - place the cuvette in the cuvette holder.
Note
• The BVS cuvette has to be outside the cuvette holder until
the function check of the blood monitor has been completed
(Priming button is flashing).
Note
6. Dialyzer - attach the dialyzer end of the arterial line firmly to the
dialyzer.
Figure 4:4 Arterial blood line in HD, set-up
7. Heparinization - using the heparin pump. See the following pages

for instructions on how to attach the syringe to the heparin pump,
and setting the heparin values in the machine.
WARNING
The operator must take proper precaution in order to prevent
coagulation in the extracorporeal circuit.
Coagulation may lead to:
• inadequate delivery of dialysis
• risks associated with propagation of blood clots to the patient
• disabling of the air detector function if blood clots aggregate in the
drip chamber
WARNING
Note
• Make sure that the heparin pump is adjusted for the syringe size
that is being used.
Note
Preparations if the heparin pump is to be used
If heparinization is desired by using the heparin pump the preparations
are made in the two following steps:
1. Attach the syringe to the heparin pump:
a. Prepare a syringe with the desired amount of heparin solution (or

other anticoagulantia).
b. Attach the syringe to the heparin line on the arterial blood line.
c. Prime the heparin line with the solution to the point where the
heparin line ends in the arterial blood line.
d. Pull out the piston on the heparin pump to end position.
Figure 4:5 Change position of the heparin pump holder
To change the position of the piston, press the end of the piston, hold it in
and move the holder. When the piston is released the holder cannot move.
e. Insert the syringe in the pump; the plastic collar at the end of the
syringe must fit in the groove of the pump.
f. Push back the piston and insert the plastic plate on the plunger in
the groove by the locking wheel.
g. Turn the locking wheel upwards until resistance is felt. This is to lock
the plastic plate of the plunger in the groove.
h. Check that the syringe is properly secured by lightly pulling on the

plunger.
Figure 4:6 Syringe attached to heparin pump
2. Set the heparin values in the machine:
a. Press the Heparin button briefly.
b. Select the heparin flow rate (ml/h).
c. Check/adjust the STOP TIME in minutes i.e. at which time the

heparinization should stop before treatment ends.
As soon as the treatment starts (priming detector detects blood) the

heparinization starts (the Heparin button: lights up). To start heparinization
during priming, press the Heparin button for 3 seconds. If the set value is 0
when the priming detector detects blood, the Heparin button starts to flash
and an attention is given.
CAUTION
To prevent the syringe from loosening from the heparin pump
during treatment the syringe plunger has to be thoroughly secured.
Check by lightly pulling on the plunger. When doing so, it must be
impossible to pull the syringe out of the heparin pump.
CAUTION
Venous blood line
Follow the instructions for the use of the venous blood line.
Specifically observe the following items.
1. Venous line clamp - place the patient end of the venous line in the
line clamp colour-coded with the blue dot.
CAUTION
Check carefully that the venous blood line is correctly placed in
the priming detector.
CAUTION
2. Air detector - place the venous drip chamber in the air detector. The
venous drip chamber should be placed as low as possible to prevent
air from passing into the venous line. At the same time it should be
possible to adjust the level well above the air detector head. Close the
air detector cover.
3. Venous pressure transducer connector - attach the transducer

4. Dialyzer - attach the dialyzer end of the venous line firmly to the
dialyzer.
Figure 4:7 Venous blood line in HD, set-up
Priming
Priming and rinsing the extracorporeal circuit
Before priming
• Connect the arterial line to the priming fluid.
• Check that the venous line is correctly positioned in the priming

detector.
• Check all connections.
• Check that the priming UF rate is correct by pressing the

UF rate button, check PRIMING. Follow the instruction for use of
the dialyzer.
Note
• A flashing Bicarbonate or Acetate button indicates that Concentrate
stand-by mode is active. Resume dialysis fluid preparation
(deactivate concentrate stand-by mode) by pressing the flashing
button once. The dialysis fluid will be ready within approximately
3 minutes.
Note
Priming and rinsing procedure

1. Press the flashing Priming button for three seconds to activate priming
(lights up).
2. Follow the manufacturer’s instructions for use of the dialyzer and

the blood lines.
WARNING
Do not use the level adjustment buttons in combination with blood
lines incorporating the ”balloon” type transducer protector, as the
venous pressure reading might be adversely affected.
WARNING
3. Press the flashing Blood pump button. The blood flow rate will
automatically start at 100 ml/min. Adjust the blood flow. If the blood
pump segment has been automatically threaded, check for possible
kinks. Prime and de-air the blood lines and the dialyzer.
4. Adjust the level in the venous drip chamber, so the level is well above
the air detector head.
5. Attach the dialysis fluid tubes to the dialyzer when the time appears
on the time display instead of Fch and the bypass path lights up on
the flow diagram. Press the flashing Fluid bypass button and the dialysis
fluid will enter the dialyzer when the bypass path lights up green
on the flow diagram.
6. When the level in the air detector is correct, the Air detect button
will start flashing and an attention regarding the inactivated air
detector will appear. The buzzer can be muted but the attention
will remain until the air detector is activated (manually when
desired/automatically if the PRIMING VOLUME ACHIEVED
attention alarm appears or when blood has been detected).
7. When the priming volume has been achieved, the blood pump
automatically stops and the attention

appears.
Note
• Always follow the manufacturer’s recommendations for the minimum
rinsing volume (for the blood lines and the dialyzer).
Note
8. If necessary, continue priming by pressing the flashing

Blood pump button. When a certain amount of extra priming volume
has been used this attention appears:
EXTRA PRIMING VOLUME ACHIEVED

Check priming fluid and waste bag. Stop the blood pump.
If the operator wishes to restart priming, and at the same time set the
priming volume value to zero, the Priming button has to be pressed for 3
seconds to exit priming mode. The Priming button starts to flash. After
that, press the Priming button again to activate priming. The Priming button
will light up and it is possible to repeat the priming procedure.
Note
Note
Initiating
Set the treatment parameters

CAUTION
To avoid hazardous side effects during the treatment, parameters
set should be suitable for the patient’s needs and tolerance.
The correct setting of the UF rate is important to avoid backfiltration.

Set a minimum UF rate according to the instruction for the specific
dialyzer.
CAUTION
Note
• Negative pressure may cause generation of ”microbubbles”.
Note
Always check/adjust
• Check the time on the Time display. Adjust if necessary; press the
Time button, adjust REMAIN.
• Check the required UF volume (patient weight loss). Press the

UF volume button, check SET, adjust if necessary.
• Check that the calculated UF rate (patient weight loss/h) is suitable.

Press the UF volume button, check CALC UFR. Adjust time or UF
volume if necessary.
• Check that the minimum UF rate is set to the required value. Press
the UF rate button, check MIN UFR, adjust if necessary.
• Check that the dialysis fluid flow rate is set to the required value.
Press the Fluid flow button, check SET, adjust if necessary.
CAUTION
Once the treatment parameters are set the user should verify that
the control and protective systems (see chapter 1) for conductivity
and temperature operate with the desired values and that they are
in agreement. This verification is made by comparing the bargraph
displays and the information display before connecting the patient.
CAUTION
Connect the patient
Note
3 minutes.
Note
1. Check that there is no air in the blood lines and that the level in the
venous drip chamber is well above the air detector head. If expansion
chambers are used, check that they are filled to the correct levels
(refer to the instructions for use of the individual blood line).
2. Activate the air detector by pressing the Air detect button if it has not
previously been activated during priming.
Note
• If the air detector has not been previously activated, it will
automatically be activated when the priming detector detects blood.
Note
3. When the priming and rinsing procedure is complete, check that the
blood pump has been stopped, if not, press the Blood pump button.
Adjust the blood flow rate to the proper start value.
Note
Note
4. Connect the blood lines to the patient.
Note
• The blood pump can automatically be stopped when the priming
detector detects blood in the venous line and the blood path of the
flow diagram lights up.
Note
5. Remove any obstructing clamps.
6. Start the blood pump and set the required blood flow rate suitable
for the patient.
When the priming detector detects blood in the venous line, the blood
path in the flow diagram will light up red. The Start UF Stop button, the
Venous pressure button, the Arterial pressure button and the TMP button starts
to flash. If no heparin value has been set, the Heparin button will also flash.
The machine will start to count down the treatment time at the same
time as blood is detected.
When blood has been detected for 20 seconds the blood path will remain
lit until treatment has been discontinued. This is valid even if the venous
blood line is removed from the priming detector.
Start the treatment

CAUTION
Make sure that the blood path of the flow diagram lights up, if it does
not light up, check that the venous blood line is correctly placed in
the priming detector. If the blood path does not light up, the machine
considers the patient not connected and as a consequence the UF
system is not controlling the patient ultrafiltration.
If the air detector has not been activated during priming it will not be
automatically activated until the priming detector detects blood.
CAUTION
1. Press the flashing Start UF Stop button (steady light) to start

ultrafiltration. (The machine will start to count down the treatment
time at the same time as blood has been detected.)
2. Press the flashing Venous pressure, Arterial pressure and TMP buttons to
set the alarm limits around the current pressures. To set the limits
manually press the respective button and change the values on the
information display by using the Arrow buttons and the Set knob.
Note that the TMP alarm limits should be set in accordance with the
UF rate and dialyzer UF coefficient.
3. If the Heparin button flashes, press the button to confirm no

heparinization using the heparin pump, or set the values. See “Arterial
blood line, Heparinization” in this chapter.
4. If the BPM, the BVS or the Diascan functions are going to be used
during treatment, see the corresponding chapters for activation and
settings.
Note
• When no other screen is displayed on the information display, the
Treatment overview screen will be displayed at all times during
treatment1. On this screen, the operator can obtain an overall picture
of parameter values, valid at that time, for the on-going treatment.
See “Treatment overview screen” in the “Controlling the machine -
general guidelines” chapter for details.
Note
1 Can be removed by preset
Pressure alarm limits setting
The machine is equipped with a centralizing function to simplify the
correct setting of the pressure alarm limits. If there is a choice not to
use the centralizing function as a preset or wide alarm limits range are
preset, it is the operator’s responsibility to check that the alarm limits are
set around current pressure.
When the alarm limits are outside the preset range, the respective button
starts to flash. If 2.5 min. of the treatment have elapsed and the alarm
limits are still outside the preset range, an attention alarm is activated.
(The Attention alarm button can be pressed in order to read on the
information display which pressure limits that need to be adjusted). When
the respective button has been pressed the alarm limits will centralize
around the current pressure.
Venous/Arterial pressure
The alarm display automatically widens and the button starts to flash
when the blood flow is changed or when the Blood pump button is pressed.
The alarm display may also be widened temporarily: Press the

Venous pressure button followed by the Arrow button beneath the required
alarm limit and adjust that specific limit. (The Venous pressure button will
start to flash as described above as soon as the alarm display is outside
the preset range).
TMP
when the blood flow is stopped. Also when the UF equation is changed
or when the Start UF Stop button is pressed the button will start to flash.
The alarm display may also be widened temporarily: Press the TMP button
followed by the Arrow button beneath the required alarm limit and adjust
that specific limit. (The button will start to flash as soon as the alarm
display is outside the preset range).
CAUTION
CAUTION
Low venous pressure alarm limit setting below +10 mmHg
During certain conditions a very low venous pressure can occur e.g. when
a central venous catheter is being used. In order to perform a dialysis
treatment under this condition it can be necessary to set the low alarm
limit below the normal limit of +10 mmHg. To make this possible the
AK 200 S can be preset upon request from the clinic. However, the
following conditions have to be fulfilled:
• The function has to be ordered by the physician
• The machine has to be identified/labelled
• The preset has to be documented in the machine logbook
CAUTION
If a venous pressure alarm limit below +10 mmHg is set, a
disconnection of the venous blood line may not be detected through
a venous pressure drop. Special attention from the operator is
therefore mandatory.
CAUTION
Operating and setting

1. Press the Venous pressure button.
2. Press the LOW and HIGH arrows simultaneously and move the alarm
limit below +10 mmHg.
The centralizing function will now work below +10 mmHg.
Discontinuing
In order to maintain a high level of performance of the AK 200 S
machine, it is recommended that the machine carries out a disinfection
program after each treatment. When the treatment is finished certain
conditions must have been fulfilled for the machine to be able to start
a disinfection program; end of treatment must have been confirmed;
the patient must be completely disconnected from the machine and the
blood path on the flow diagram must be extinguished; the dialysis fluid
tubes must be connected to the safety couplings on the machine; the used
concentrates must be removed i.e. the concentrate pick-up tubes must
be placed in the disinfection ports of the machine, and the latches of the
SelectBag, SelectCart and the BiCart holders must be closed.
Automatic emptying of BiCart, SelectCart and SelectBag

If the BiCart Select system or the BiCart cartridge has been used during
treatment, it is possible for the machine to automatically empty the
containers after use. This will take some minutes and will vary depending
on how much concentrate remains in the containers. The emptying
procedure of the containers can be started at any time during the
discontinuing procedure after treatment end has been confirmed. This
means that it can be done while the blood is being returned to the patient,
or directly after, in order to shorten the time before the disinfection
program can be started, see the conditions mentioned above. It can
also be done when the blood has been returned to the patient and the
blood path of the flow diagram has been extinguished (confirmed patient
disconnection).
Once the automatic emptying procedure of the containers has been
started (Arrow button pressed), the fluid unit of the machine will
automatically be disconnected and the dialysis fluid to the dialyzer will be
bypassed. The blood alarms will remain active (if automatic emptying is
started before the blood path of the flow diagram has been extinguished).
The treatment time displayed on the time display will be set to zero and
it will not be possible to return to treatment. It should be particularly
noted that if the emptying procedure is started before the blood has been
returned to the patient, the blood should be returned to the patient as
soon as possible since diffusion is consequently disabled.
Discontinuing procedure
Note
• If the treatment is to be discontinued before the set treatment time
is achieved, the remaining time should be changed to 0:00 (press
Time button, change by using the Set knob).
Note
Confirm treatment end

When the remaining treatment time shown on the Time display equals
0:00 an attention alarm appears:
TREATMENT TIME EXPIRED

Press TIME key to confirm
At this moment the UF rate will be automatically reduced to minimum

UF rate as the set UF volume is achieved; the Start UF Stop button will be
extinguished to indicate this. The time shown on the time display will
continue to count down but will show negative figures.
1. Confirm treatment end by pressing the flashing Time button. When

this is done the TMP alarm limits will widen.
If desired, start emptying BiCart or BiCart, SelectCart and SelectBag

2. If used and if desired, start emptying the SelectBag, the SelectCart
cartridge and BiCart cartridge (All) or only the BiCart cartridge
(BiCart) at this point. Once the emptying procedure has been
started (Arrow button pressed), the fluid unit of the machine will
automatically be disconnected and the dialysis fluid to the dialyzer
will be bypassed. The blood alarms will remain active. The treatment
time will be set to zero and it will not be possible to return to
treatment. For further information, see in "Automatic emptying of
BiCart, SelectCart and SelectBag" previously in this section.
2.a. Open the upper latch(es) of the cartridge holder(s), pull out the
latch(es) and lift upwards to their uppermost positions.
2.b. Press the Bicarbonate button twice, select All or BiCart by

pressing corresponding Arrow button. Once the Arrow button has
been pressed, the emptying procedure will start (see in 2 above).
The SelectBag will automatically be drained after the cartridges
has been drained if All has been selected.
Return the blood

3. Stop the blood pump. This will automatically widen the venous
and arterial pressure alarm limits to their priming values without
a subsequent centralizing alarm. The blood flow rate will now
automatically be set to 100 ml/min.
4. Clamp the arterial blood line and disconnect it from the patient.
5. Connect the arterial blood line to the rinse-back solution and remove
the clamp.
6. Start the blood pump, the rinse-back flow rate (blood flow rate) is set
to 100 ml/min, adjust if required.
CAUTION
After having started the blood pump again, the operator is
responsible for the monitoring of the venous pressure.
CAUTION
Note
detector stops detecting blood in the venous line.
Note
7. Stop the blood pump and clamp the venous blood line when the
required amount of blood has been returned to the patient.
8. Disconnect the venous blood line from the patient.
9. Check that the patient is not connected to the machine in any way
and that the blood pump has been stopped.
10. Remove the venous blood line from the priming detector.
11. Confirm patient disconnection; manually extinguish the blood path

of the flow diagram by briefly pressing one of the Rinse/Drain,
Heat disinf, or Chem disinf buttons. When this is done the machine does
not detect blood anymore (the treatment time will be frozen, the air
detector has now been bypassed and it is not possible to run the
blood pump).
After-treatment handling of the machine

12. If used and if not previously done, start emptying the SelectBag, the
SelectCart cartridge and BiCart cartridge or only the BiCart cartridge.
Once the emptying procedure has been started (Arrow button pressed),
the fluid unit of the machine will automatically be disconnected and
the dialysis fluid to the dialyzer will be bypassed. The treatment time
will be set to zero and it will not be possible to return to treatment.
12.a. Open the upper latch(es) of the cartridge holder(s), pull out the
latch(es) and lift upwards to their uppermost positions.
12.b. Press the Bicarbonate button twice, select All or BiCart by

pressing corresponding Arrow button. Once the Arrow button has
been pressed, the emptying procedure will start (see in 12 above).
The SelectBag will automatically be drained after the cartridges
has been drained if All has been selected.
13. If the pick-up tubes have been used for concentrates, place them in
the disinfection ports of the machine. Once this is done, the fluid unit
of the machine will automatically be disconnected and the dialysis
fluid to the dialyzer will be bypassed. The treatment time will be set
to zero and it will not be possible to return to treatment.
14. If used, remove the empty BiCart and SelectCart cartridge(s) after
draining and close both the latches of the cartridge holder(s) properly
(vertical position). (To close the lower latch; pull out and close.)
If used, also remove the SelectBag when it is empty (or earlier if
desired) by lifting the latch upwards. Then remove the SelectBag, pull
out the latch and close it properly (vertical position).
WARNING
Avoid touching the plastic spike.
Be careful to avoid fluid from the SelectBag splashing into your eyes.
WARNING
15. Invert the dialyzer. Disconnect the outlet dialysis fluid tube (to
dialyzer) from the dialyzer and attach it to the safety coupling of
the machine. The AK 200 S will now automatically create negative
pressure in the fluid path, which empties the dialyzer of dialysis fluid.
16. When the dialyzer has been emptied, disconnect the inlet dialysis
fluid tube from the dialyzer and attach it to the safety coupling of
the machine as well.
17. Start a disinfection program, see handling instructions for each

program in chapter 12, "Hygiene and maintenance", in this manual.
18. Open the door to the BVS cuvette holder.
19. Remove the dialyzer and the blood lines, dispose of according to
local regulations.
20. Follow the instructions for hygiene and maintenance of the AK 200 S
machine in chapter 12, "Hygiene and maintenance", in this manual.
CAUTION
If any of the pressure transducer protectors on the blood lines
have been filled with blood and show signs of damage, i.e. blood
has penetrated the disc filter, there is a risk of contamination of
the machine. It is necessary to call an authorized technician who
must replace and clean machine components that may have been
contaminated.
CAUTION
Chapter 5
Hemodialysis, single needle treatment

Single needle treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:2
General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:2
Glossary of single needle parameters and key terms . . . . . . . . . . . . 5:3
Single needle treatment with two blood pumps - BM 202 only . . . . . . . . . 5:4
Preparations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:4
Priming . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:6
Priming and rinsing procedure in double needle mode, finishing
in single needle/double pump mode . . . . . . . . . . . . . . . . . . . . . 5:6
Priming and rinsing procedure in single needle/double pump
mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:9
Initiating . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:11
Always check/adjust . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:11
TMP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:15
Discontinuing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:17
Single needle treatment with one blood pump . . . . . . . . . . . . . . . . . . . . . 5:18
Preparations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:18
Discontinuing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:23
Double needle to single needle treatment - change during treatment . . 5:24
Resume treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:24
Discontinuing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:27
Program version 8.xx AK 200 S Operator’s manual - Single needle 5:1
Single needle treatment
General
The blood monitor offers a single needle facility using either one or two
blood pumps (two blood pumps only possible with BM 202). Single
needle treatment with two blood pumps is controlled by the stroke
volume which gives an optimized accumulated blood volume for the
treatment. Single needle treatment with one blood pump uses the arterial
and venous clamps, which can be controlled and supervised by either
time or pressure settings.
Note
• When performing single needle treatment there is always a certain
amount of recirculation.
The AK 200 S is equipped with a clamp on the arterial side in order
to minimize recirculation.
To further minimize recirculation the stroke volume should be
maximized. To achieve this the following should be considered:
- Make sure a correct blood pump rotor is used. There must be a
correct adjustment of the occlusion of the blood pump segment
being used. Check with the service technician responsible.
- The volume of the expansion chamber(s) should be as big as
possible.
- The internal diameter of the needle should be as big as possible.
• Single needle treatment with two blood pumps cannot be selected if

Low volume HDF mode is to be performed.
• Make sure that the venous blood pump is adjusted for the right pump
segment diameter when single needle/double pump is performed.
Note
5:2 AK 200 S Operator’s manual - Single needle Program version 8.xx
Glossary of single needle parameters and key terms
Single needle, double pump
The Arterial phase is when the arterial blood pump is running. The
arterial blood pump runs until the system pressure high alarm limit has
been reached.
The Venous phase is when the venous blood pump is running. The
venous blood pump runs until the stroke volume has been achieved.
Cycle, together, an arterial phase and a venous phase are called a cycle.
The Mean blood flow rate is the effective blood flow rate during the
complete cycle, calculated from the venous blood flow rate. The mean
blood flow rate can be adjusted by adjusting the blood flow rates for the
arterial pump and the venous pump separately.
The Stroke volume is the blood volume that passes through the dialyzer
during a cycle. The lower the stroke volume the greater the recirculation.
The System pressure is measured after the dialyzer before the venous
blood pump. The pressure fluctuates between the arterial phase and the
venous phase, increasing during the arterial phase, decreasing during the
venous phase. The machine uses the system pressure high alarm limit to
control the arterial phase.
Single needle, single pump

The Arterial phase is when the blood pump is running, the arterial line
clamp is open and the venous line clamp is closed. The arterial phase can
either be controlled by time or pressure settings.
The Venous phase is when the blood pump is not running, the venous
line clamp is open and the arterial line clamp is closed. The venous phase
can either be controlled by time or pressure settings.
Cycle, together, an arterial phase and a venous phase are called a cycle.
The Mean blood flow rate is the effective blood flow rate during the
complete cycle, calculated from the arterial blood flow rate.
The Stroke volume is the blood volume that passes through the dialyzer
during a cycle. The lower the stroke volume the greater the recirculation.
Single needle treatment with two blood
pumps - BM 202 only
Preparations
Follow the instructions in chapter 4 "Double needle treatment" beginning
with "Check before starting the machine". Continue up to "Arterial blood
line" in "Attaching the dialyzer and the blood lines".
Arterial blood line

Continue to follow the instructions in chapter 4 in "Arterial blood line".
Add the following item below, which refers to single needle/double
pump treatments.
1. Arterial expansion chamber - place the expansion chamber in the

holder (inlet and outlet facing downwards).
Figure 5:1 Arterial blood line with expansion chamber in HD, single needle/double pump, set-up
Venous blood line
Continue to follow the instructions in chapter 4 in "Venous blood line".
Add the following items below, which refer to single needle/double
pump treatments.
1. Venous blood pump - leave the venous blood pump segment outside
the pump housing as priming with one blood pump is recommended.
See “Priming and rinsing procedure” further on in this chapter.
2. Venous expansion chamber - place the expansion chamber in the

holder (inlet and outlet facing downwards).
3. System pressure transducer connector - attach the transducer

Figure 5:2 Venous blood line with expansion chamber in HD, single needle/double pump, set-up
Priming
Priming and rinsing the extracorporeal circuit
Before priming
• Connect the arterial line to the priming fluid.
• Check that the venous line is correctly positioned in the priming

detector.
• Check all connections.
• Check that the priming UF rate is correct by pressing the

UF rate button, check PRIMING. Follow the instruction for use of
the dialyzer.
Note
3 minutes.
Note
Priming and rinsing procedure

The priming and rinsing procedure can be performed either in
double needle mode or in single needle/double pump mode. (The
recommended procedure is in double needle mode as it is easier and
less time-consuming.)
The priming and rinsing procedure in double needle mode is described

below as the first alternative. It is followed by the description of the
procedure in single needle/double pump mode.
Priming and rinsing procedure in double needle mode, finishing in single

needle/double pump mode
1. Tilt the double chamber holder backwards until it clicks into position.
By doing so the expansion chambers will be filled to a suitable level
during priming.
2. Check that the venous blood line segment has not been inserted into
the venous blood pump.
(lights up).

the blood lines.
WARNING
WARNING
5. Press the flashing Blood pump button. The blood flow rate will
automatically start at 100 ml/min. Adjust the blood flow. If the
arterial blood pump segment has been automatically threaded, check
for possible kinks. Prime and de-air the blood lines and the dialyzer.
9. When the priming volume has been achieved, the blood pump

appears.
Note
Note
10. Place the double chamber holder back in its upright position.
11. Open the cover of the venous blood pump and place the venous
pump segment inside the pump housing as in the figure below.
The pump segment can be threaded manually or automatically.
rotor and close the blood pump cover, the blood pump segment
will be threaded as soon as the flashing Blood pump button has
been pressed.
12. Press the SN button briefly. Check that double pump mode has
been selected, (DOUBLE PUMP will be flashing), or select
DOUBLE PUMP by using the corresponding Arrow button. Activate
the function by pressing the SN button for three seconds (lights up).
13. Press the flashing Blood pump button and let the machine go through
a few cycles in double pump mode. At the same time, check that
the arterial and venous blood pumps alternate sufficiently. If the
venous blood pump segment has been automatically threaded, check
for possible kinks.
14. Stop the blood pump or, if necessary, continue priming. When
a certain amount of extra priming volume has been used this
attention appears:

If this is done, remember to remove the venous blood pump segment
from the venous pump and deactivate the SN function to be able to
repeat the priming procedure from the beginning.
Note
Note
Priming and rinsing procedure in single needle/double pump mode
1. Tilt the double chamber holder backwards until it clicks into position.
By doing so the expansion chambers will be filled to a suitable level
during priming.
2. Open the cover of the venous blood pump and place the venous
pump segment inside the pump housing as in the figure below.
The pump segment can be threaded manually or automatically.
rotor and close the blood pump cover, the blood pump segment
will be threaded as soon as the flashing Blood pump button has
been pressed.
3. Press the SN button briefly. Check that double pump mode has
been selected, (DOUBLE PUMP will be flashing), or select
DOUBLE PUMP by using the corresponding Arrow button. Activate
the function by pressing the SN button for three seconds (lights up).
(lights up).

the blood lines.
WARNING
WARNING
6. Press the flashing Blood pump button. The mean blood flow rate will
automatically start at 100 ml/min. Adjust the mean blood flow. If
the blood pump segments has been automatically threaded, check for
possible kinks. Prime and de-air the blood lines and the dialyzer.
7. Check that the arterial and venous blood pumps alternate sufficiently.
11. When the priming volume has been achieved, the blood pumps

appears.
Note
Note
12. Place the double chamber holder back in its upright position.
13. If necessary, continue priming by pressing the flashing

Blood pump button. When a certain amount of extra priming volume
has been used this attention appears:

Note
Note
Initiating
Set the treatment parameters

CAUTION
To avoid hazardous side effects during the treatment, parameters
set should be suitable for the patient’s needs and tolerance.
The correct setting of the UF rate is important to avoid backfiltration.

Set a minimum UF rate according to the instruction for the specific
dialyzer.
CAUTION
Note
• Negative pressure may cause generation of ”microbubbles”.
Note
Always check/adjust
• Check the time on the Time display. Adjust if necessary; press the
Time button, adjust REMAIN.
• Check the required UF volume (patient weight loss). Press the

UF volume button, check SET, adjust if necessary.
• Check that the calculated UF rate (patient weight loss/h) is suitable.

Press the UF volume button, check CALC UFR. Adjust time or UF
volume if necessary.
• Check that the minimum UF rate is set to the required value. Press
the UF rate button, check MIN UFR, adjust if necessary.
• Check that the dialysis fluid flow rate is set to the required value.
Press the Fluid flow button, check SET, adjust if necessary.
CAUTION
Once the treatment parameters are set the user should verify that
the control and protective systems (see chapter 1) for conductivity
and temperature operate with the desired values and that they are
in agreement. This verification is made by comparing the bargraph
displays and the information display before connecting the patient.
CAUTION
Connect the patient
Note
3 minutes.
Note
1. Check that single needle mode has been activated (lit SN button). Also
check that double pump mode has been selected; DOUBLE PUMP
will be flashing on the information display.
2. Check that the venous blood pump segment has been properly
inserted into the venous blood pump.
3. Check that the expansion chambers are in an upright position and

are filled to the correct levels (refer to the instructions for use of
the individual blood line).
venous drip chamber is well above the air detector head.
Note
Note
blood pumps have been stopped, if not, press the Blood pump button.
Adjust the mean blood flow rate to the proper start value.
Note
Note
Note
Note
9. Start the blood pumps and set the required mean blood flow rate
suitable for the patient.
Venous pressure button (if the Venous pressure is below +10 mmHg) and
the TMP button starts to flash. If no heparin value has been set, the
Heparin button will also flash.
Start the treatment

CAUTION
CAUTION

2. Press the flashing TMP button to automatically set the alarm limits
around the current pressure. Note that the TMP alarm limits should
be set in accordance with the UF rate and dialyzer UF coefficient.
3. If the Venous pressure button is flashing, press the button to

automatically set the low alarm limit to +10 mmHg.
4. Press the Venous pressure button to manually set the alarm limits around
the current pressure. Change the limits on the information display
by using the Arrow buttons and the Set knob.
5. Press the Arterial pressure button to manually set the alarm limits around
the current pressure. As the arterial pressure fluctuates during the
cycle the alarm window has to be set accordingly. Change the limits
on the information display by using the Arrow buttons and the Set knob.
6. If necessary, adjust the levels in the expansion chambers. The levels

should be as low as possible (i.e. without air passing into the blood
lines at the end of the venous phase), in order to best achieve the
stroke volume (SET).
7. Press the SN data button. Check that the current stroke volume
(STROKE) corresponds with the set value (SET). At the same time,
read off the system pressure (PRESSURE). See "Glossary of single
needle parameters and key terms" previously in this chapter for
further information.
Note
• It is possible to optimize the current mean blood flow rate by
adjusting the blood flow rate for the venous pump or the arterial
pump separately. This results in more cycles1 during treatment i.e.
increased accumulated blood volume. Note that the arterial pump
never runs faster than twice the speed, or more slowly than half the
speed, of the venous pump and vice versa.
If this optimization is desired:
Press the Blood flow button, select VEN and/or ART by using the
Arrow buttons. Adjust the blood flow rates, making sure that venous
and arterial pressure remain within the limits recommended by the
clinic for that particular patient’s blood access.
Note

blood line, Heparinization” in chapter 4.
settings.
Note
• When no other screen is displayed on the information display, the
Treatment overview screen will be displayed at all times during
treatment2. On this screen, the operator can obtain an overall picture
of parameter values, valid at that time, for the on-going treatment.
See “Treatment overview screen” in the “Controlling the machine -
general guidelines” chapter for details.
Note
1 For further information, see "Glossary of single needle parameters and key terms"
previously in this chapter
2 Can be removed by preset
Pressure alarm limits setting
TMP
The machine is equipped with a centralizing function to simplify the
correct setting of the TMP alarm limits. If there is a choice not to use
the centralizing function as a preset or wide alarm limits range are preset,
it is the operator’s responsibility to check that the alarm limits are set
around current pressure.
When the alarm limits are outside the preset range, the TMP button starts
to flash. If 2.5 min. of the treatment have elapsed and the alarm limits are
still outside the preset range, an attention alarm is activated:
TMP LIMITS ADJUST

Press TMP key
Press the TMP button to centralize the alarm limits around the current
pressure.
when the blood flow is stopped. Also when the UF equation is changed
or when the Start UF Stop button is pressed the button will start to flash.
The alarm display may also be widened temporarily: Press the TMP button
followed by the Arrow button beneath the required alarm limit and adjust
that specific limit. (The button will start to flash as soon as the alarm
display is outside the preset range).
CAUTION
CAUTION
Venous/Arterial pressure
There is no centralizing function for Arterial and Venous pressure when
performing single needle treatments. The alarm limits has to be set
manually.
The Arterial pressure alarm limits may be widened temporarily when the
blood flow rate has been changed, or when the blood pump(s) has been
stopped. Press the Arterial pressure button followed by the Arrow button
below the required alarm limit and adjust that specific limit.
As soon as the Venous pressure low alarm limit is set below +10 mmHg
the button starts to flash. Press the Venous pressure button and the low
alarm limit will automatically be set to +10mmHg.
Low venous pressure alarm limit setting below +10 mmHg
During certain conditions a very low venous pressure can occur e.g. when
a central venous catheter is being used. In order to perform a dialysis
treatment under this condition it can be necessary to set the low alarm
limit below the normal limit of +10 mmHg. To make this possible the
AK 200 S can be preset upon request from the clinic. However, the
following conditions have to be fulfilled:
• The function has to be ordered by the physician
• The machine has to be identified/labelled
• The preset has to be documented in the machine logbook
CAUTION
If a venous pressure alarm limit below +10 mmHg is set, a
disconnection of the venous blood line may not be detected through
a venous pressure drop. Special attention from the operator is
therefore mandatory.
CAUTION
Operating and setting

1. Press the Venous pressure button.
2. Press the LOW and HIGH arrows simultaneously and move the alarm
limit below +10 mmHg.
The centralizing function will now work below +10 mmHg.
Discontinuing
The discontinuing procedure can be performed either in double needle
mode or in single needle/double pump mode. (The recommended
procedure is in double needle mode as it is easier and less time-consuming.)
Discontinuing in double needle mode after single needle/double pump treatment

Follow the instructions in chapter 4 "Discontinuing" and "Discontinuing
procedure". Add the following instructions below, after point 3 (Stop the
blood pump) in "Return the blood".
1. Press the lit SN button for 3 seconds to deactivate the single needle
function.
2. Remove the venous pump segment from the venous blood pump.
3. Continue by following the instructions in "Return the blood" in

chapter 4, starting with point 4.
Discontinuing in single needle/double pump mode

procedure" without deactivating the single needle function.
Single needle treatment with one blood
pump
Preparations
Follow the instructions in chapter 4 "Double needle treatment" beginning
with "Check before starting the machine". Add the following below.
Attach an expansion chamber, connecting it between the dialyzer and the

venous blood line. This is in order to reduce the amount of recirculation
in the system (i.e. to achieve a greater stroke volume). Follow the
instructions in chapter 4, "Venous blood line" in "Attaching the dialyzer
and the blood lines", and attach the expansion chamber as in the figure
5:5.
1. Venous expansion chamber - place the expansion chamber in the

holder in an upright position (inlet and outlet facing downwards).
2. Connect the dialyzer end of the venous blood line to the blood line
with the expansion chamber.
3. Connect the blood line with the expansion chamber to the dialyzer.
Do not connect the line at the top of the expansion chamber to the
system pressure transducer (the system pressure is not used when
single needle/single pump treatment is performed).
Figure 5:5 Venous blood line with attached expansion chamber in HD, single needle/single pump, set-up
Prime and de-air the blood lines and the dialyzer as described in chapter 4.
The venous expansion chamber should be filled to be level with the
groove of the chamber. Close the clamp at the top of the expansion
chamber.
Single needle / single pump settings

The arterial and venous phases during a cycle can either be controlled by
pressure or time settings. In practice this means that if the times for the
phases are maximized to 20 seconds, the high and low venous pressure
alarm limits set will control the phases. Pressure control settings usually
imply more cycles and a greater accumulated blood volume for the
treatment. The following pages include instructions for both the variants.
Continue to follow the instructions in chapter 4 up to "Connect the

patient" in "Initiating hemodialysis".
Connect the patient

Note
3 minutes.
Note
For both pressure- and time-controlled phases

1. Press the SN data button briefly and check/adjust the preset times for
the arterial and venous phases; at this point they should be adjusted
to suitable times to be used during patient connection and treatment
start. Adjust the times below VEN TME and ART TME separately
by using the Arrow buttons and the Set knob.
2. Check that the venous expansion chamber is in an upright position

and is filled to a correct level (refer to the instructions for use of
the individual blood line).
venous drip chamber is well above the air detector head.
Note
Note
blood pump has been stopped, if not, press the Blood pump button.
Adjust the blood flow rate to the proper start value.
Note
Note
6. Press the SN button briefly and select SINGLE PUMP by using

the corresponding Arrow button; SINGLE PUMP will be flashing.
Activate the function by pressing the SN button for 3 seconds (lights
up).
Note
Note
9. Start the blood pump and set the arterial blood flow rate (ART FL).
Check that the resulting mean blood flow rate (MEAN FL) is the
required flow, suitable for the patient.
Venous pressure button (if the Venous pressure is below +10 mmHg) and
the TMP button starts to flash. If no heparin value has been set, the
Heparin button will also flash.
Start the treatment
CAUTION
CAUTION
For both pressure- and time-controlled phases

2. Press the flashing TMP button to automatically set the alarm limits
around the current pressure. Note that the TMP alarm limits should
be set in accordance with the UF rate and dialyzer UF coefficient.
3. If the Venous pressure button is flashing, press the button to

automatically set the low alarm limit to +10 mmHg.
Depending on whether pressure- or time-controlled phases are to be

used, continue by following the instructions starting with position 4 for
each variant.
Only for pressure-controlled phases

4. Press the SN data button briefly and maximize the preset times for the
arterial and venous phases to 20 seconds . Set the times separately
below VEN TME and ART TME by using the Arrow buttons and the
Set knob.
5. Press the Venous pressure button. Set the high venous pressure alarm
limit to, say, +400 mmHg. After this, during the arterial phase,
gradually adjust the low venous pressure alarm limit to, say, +200
mmHg. Make sure that the venous pressure alarm limits remain
within the limits recommended by the clinic for that particular
patient’s blood access. See Note below for further information about
this setting.
7. If necessary, adjust the level in the venous expansion chamber. The

level should be as low as possible (i.e. without air passing into the
blood lines at the end of the venous phase), in order to best achieve a
proper stroke volume (STROKE).
(STROKE) shows a proper value. See "Glossary of single needle
parameters and key terms" previously in this chapter for further
information.
Note
• The achieved stroke volume is determined by the size and position
of the venous pressure alarm window. The wider the window, the
greater the stroke volume. The higher the position of the window,
the higher the venous flow. Set the venous pressure alarm limits in
such a way that a proper stroke volume is being achieved. Bear in
mind that as the venous pressure alarm limits are used to control
the arterial and venous phases the extracorporeal circuit must
continuously be monitored by visual inspection. A decreasing stroke
volume and/or a decreasing mean blood flow rate may indicate
clotting or a kinked venous blood line.
To optimize the treatment:
- Check the stroke volume; press the SN data button, check
STROKE. Optimize by adjusting the venous pressure alarm window
and keeping the level in the venous expansion chamber as low as
possible.
- Maximize the arterial blood flow rate; turn the Blood flow knob,
adjust ART FL. This will shorten the arterial phase, which results in
more cycles3 during the treatment i.e. increased mean blood flow
rate (MEAN FL) resulting in increased accumulated blood volume
(ACC VOL).
Note

settings.
Continue by following "Pressure alarm limits setting" instructions under

"Single needle treatment with two blood pumps", in this chapter, as they
are the same for single needle double pump and single needle single
pump treatments.
Only for time-controlled phases

the arterial and venous phases. Adjust the times below VEN TME
and ART TME separately by using the Arrow buttons and the Set knob.
the current pressure. As the venous pressure fluctuates during the

information.

settings.

pump treatments.
Discontinuing
The discontinuing procedure can be performed either in double needle
mode or in single needle/single pump mode. (The recommended
procedure is in double needle mode as it is easier and less time-consuming.)
Discontinuing in double needle mode after single needle/single pump treatment

procedure". Add the following instructions below, after point 3 (Stop the
blood pump) in "Return the blood".
1. Press the lit SN button for 3 seconds to deactivate the single needle
function.
2. Continue by following the instructions in "Return the blood" in

chapter 4, starting with point 4.
Discontinuing in single needle/single pump mode

procedure" without deactivating the single needle function.
Double needle to single needle treatment - change
during treatment
Attach an expansion chamber, connecting it between the dialyzer and the
venous blood line. This is in order to reduce the amount of recirculation
in the system (i.e. to achieve a greater stroke volume). Follow the
instructions below.
1. Prime and de-air a blood line with an expansion chamber, the

expansion chamber should be filled to be level with the groove of
the chamber. Close the clamp at the top of the expansion chamber
and clamp the ends of the line.
2. Stop the Blood pump and stop ultrafiltration by pressing the

Start UF Stop button.
3. Clamp the venous blood line close to the dialyzer (it is recommended
to add an extra clamp on the arterial blood line close to the dialyzer
as well) and disconnect the venous blood line from the dialyzer.
4. Connect the line with an expansion chamber between the dialyzer

and the venous blood line, see figure 5:5 in "Preparations" in "Single
needle treatment with one blood pump" previously in this section.
Place the expansion chamber in the holder in an upright position
(inlet and outlet facing downwards). Do not connect the line at the
top of the expansion chamber to the system pressure transducer
(the system pressure is not used when single needle/single pump
treatment is performed).
Resume treatment
5. Press the SN button briefly and select SINGLE PUMP by using
the corresponding Arrow button; SINGLE PUMP will be flashing.
Activate the function by pressing the SN button for 3 seconds (lights
up).
7. Start the blood pump and set the arterial blood flow rate (ART FL).
Check that the resulting mean blood flow rate (MEAN FL) is the
required flow, suitable for the patient.
8. Press the flashing Start UF Stop button to start ultrafiltration. Press the
flashing TMP button to automatically set the alarm limits around
the current pressure.
Single needle / single pump settings

The arterial and venous phases during a cycle can either be controlled
by pressure or time settings. In practice this means that if the times
for the phases are maximized to 20 seconds, the high and low venous
pressure alarm limits set will control the phases. Pressure control settings
usually imply more cycles and a greater accumulated blood volume for
the treatment.
Depending on whether pressure- or time-controlled phases are to be
used, continue by following the instructions starting with position 9 for
each variant.
Only for pressure-controlled phases

9. Press the SN data button briefly and maximize the preset times for the
arterial and venous phases to 20 seconds . Set the times separately
below VEN TME and ART TME by using the Arrow buttons and the
Set knob.
10. Press the Venous pressure button. Set the high venous pressure alarm
limit to, say, +400 mmHg. After this, during the arterial phase,
gradually adjust the low venous pressure alarm limit to, say, +200
mmHg. Make sure that the venous pressure alarm limits remain
within the limits recommended by the clinic for that particular
patient’s blood access. See Note below for further information about
this setting.
information.
Note
• The achieved stroke volume is determined by the size and position
of the venous pressure alarm window. The wider the window, the
greater the stroke volume. The higher the position of the window,
the higher the venous flow. Set the venous pressure alarm limits in
such a way that a proper stroke volume is being achieved. Bear in
mind that as the venous pressure alarm limits are used to control
the arterial and venous phases the extracorporeal circuit must
continuously be monitored by visual inspection. A decreasing stroke
volume and/or a decreasing mean blood flow rate may indicate
clotting or a kinked venous blood line.
To optimize the treatment:
- Check the stroke volume; press the SN data button, check
STROKE. Optimize by adjusting the venous pressure alarm window
and keeping the level in the venous expansion chamber as low as
possible.
- Maximize the arterial blood flow rate; turn the Blood flow knob,
adjust ART FL. This will shorten the arterial phase, which results in
more cycles4 during the treatment i.e. increased mean blood flow
rate (MEAN FL) resulting in increased accumulated blood volume
(ACC VOL).
Note

pump treatments.
Only for time-controlled phases

the arterial and venous phases. Adjust the times below VEN TME
and ART TME separately by using the Arrow buttons and the Set knob.
the current pressure. As the venous pressure fluctuates during the
information.
pump treatments.
Discontinuing
Follow the instructions in "Single needle treatment with one blood
pump", "Discontinuing" in this chapter.
Chapter 6
Isolated UF
Program version 8.xx AK 200 S Operator’s manual - Isolated UF 6:1
Follow the instructions in "Hemodialysis, double needle treatment" up to
"Connect the patient" chapter 4, after that see below.
Note
• Isolated UF can only be run in hemodialysis mode.
• Isolated UF can be performed before, in the middle of, or after the
"normal" dialysis treatment.
• Set the heparin stop limit to 0.00 if heparinization is desired during

the complete ultrafiltration phase.
Note
1. Press the Time button and set the time for the ultrafiltration phase.
2. Press the UF volume button and select the UF volume for the
ultrafiltration phase.
3. Press the Heparin button and set the heparin stop limit to the required
time.
4. Start the blood circulation according to the instructions in

"Hemodialysis, double needle treatment, Connect the patient" see
chapter 4.
5. Press the Isol UF button for 3 seconds (lights up).
6. Press the Start UF Stop button (lights up).
7. Press the flashing TMP button to set alarm limits around the current
pressures.
6:2 AK 200 S Operator’s manual - Isolated UF Program version 8.xx
When the time for the ultrafiltration phase is 0.00, an attention alarm
appears and the Time button starts to flash.
1. Press the Isol UF button for 3 seconds (the light goes out).
2. Press the Time button and set the time for the diffusion phase.
3. Press the UF volume button and select the UF volume for the diffusion
phase.
4. Press the Heparin button and set the heparin stop limit to the required
value.
5. Press the Start UF Stop button (lights up).
6. Press the flashing TMP button to set alarm limits around the current
pressures.
Note
• By pressing the Time button the information display shows passed
treatment time (PASSED) and passed treatment time without
diffusion (NON DIFF) and the time in isolated ultrafiltration mode is
included in both of these.
By pressing the UF volume button the information display shows
accumulated volume (UF VOL) and the ultrafiltration volume
achieved in isolated ultrafiltration mode is included in this.
Note
Program version 8.xx AK 200 S Operator’s manual - Isolated UF 6:3
6:4 AK 200 S Operator’s manual - Isolated UF Program version 8.xx
Chapter 7
Profiling
Profiling of Na+ and HCO3- dialysis fluid concentration . . . . . . . . . . . . . 7:2
Profiling of ultrafiltration rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7:4
Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7:5
Curve Setting/Change/Cancellation: . . . . . . . . . . . . . . . . . . . . . 7:5
Activation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7:5
Verification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7:5
Activation of profiling with already preset models . . . . . . . . . . . . . . . . 7:7
Verification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7:7
Program version 8.xx AK 200 S Operator’s manual - Profiling 7:1
Profiling of Na+ and HCO3- dialysis fluid
concentration
In order to optimize the dialysis treatment, the dialysis fluid
concentrations of sodium and bicarbonate can automatically follow a
predetermined, continuous curve changing the concentrations in a linear,
degressive or progressive graph.
A linear graph gives a constant change of concentration. A progressive

graph means that the change of concentration values accelerates and a
degressive graph means that the change of concentration slows down
during treatment time.
There are three parameters which determine the shape of the respective
profile: The start value, the stop value and the so called half-time. The
half-time describes and determines the time interval to reach halfway
between the start and stop concentration.
Different profile combinations can be programmed into three memories

(models )
The simplest type of profile is the linear one. It is determined by selecting

the linear graph and by setting a start and a stop concentration. AK 200 S
will then perform a smooth and constant adjustment during the treatment
time.
Figure 7:1 3 different graphs for profiling sodium and bicarbonate
7:2 AK 200 S Operator’s manual - Profiling Program version 8.xx
Setting individualized non-linear (exponential) profiles requires one figure
more: half-time (set in hours and minutes). Half-time determines the
time interval to reach halfway between start and stop concentration.
The individual curves can easily be drawn into a diagram. To show a
degressive graph, draw the start concentration value at time zero and stop
concentration value at end of treatment.
Figure 7:2 Profiling, Degressive graph
The progressive graph is just a reversed degressive graph.
Figure 7:3 Profiling, Progressive graph
Profiling of ultrafiltration rate
The UF rate can follow a predetermined decreasing or increasing linear
graph.
The UF profile is determined by the total UF volume, time and start
UF rate.
Figure 7:4 Linear graph for UF rate profiling
When UF profiling is used TMP is also acting as protective system.

The operator has to readjust the TMP alarm limits during treatment in
accordance with the UF rate and the dialyzer UF coefficient.
Note
• The UF profile curve will perform a parallel shift if either time or volume
are changed.
Note
Operation
Follow the instructions in "Hemodialysis, double needle treatment" up to
"Pressure alarm limits setting" chapter 4 and add the following.
Curve Setting/Change/Cancellation:
The setting is guided by menu technique, stepping back with the
Hold button.
1. Press the Profiling button briefly.
2. Select the MODEL (memory).
3. Select the parameters to be profiled. (Na+, HCO3- and UF).
Note
• The parameters that are not profiled are set by using the standard
handling for each parameter.
Note
4. Select, if an actual stored profile should be CHANGE or CANCEL. If

UF is selected, set START value in l/h (STOP value is automatically
adjusted so that the total UF volume which was previously set is
maintained).
5. Select the graph: LINEAR, PROGRESS or DEGRESS. (If UF is

selected only LINEAR can be selected.)
6. Set START value (in mmol/l), STOP value (in mmol/l), if a non
linear graph is chosen also HALF TME (in h:min).
Note
• If the remaining time is changed in priming after a certain half-time
is set, the half-time will automatically readjust, keeping the same
percentage in relation to remaining time.
Note
Activation
7. Activate the profiling mode by pressing the Profiling button for 3
seconds. As soon as blood is detected in the venous line the profiling
mode starts.
Verification
8. Verify the sodium, bicarbonate and UF-rate settings:
8.a. Press the Profiling button.
8.b. Select the parameters to be verified and press the arrow below
CHECK on the information display.
The characteristic (L: linear, D: degressive, P: progressive) and the half

time are alternatively shown on the time display.
8.c. Press the arrow below the START value and one flashing dot
on the bargraph display for conductivity will indicate the start
conductivity, if sodium and bicarbonate profiles are to be verified.
One flashing dot on the bargraph display for UF-rate will indicate
the start value for UF-rate, if UF-profile is to be verified.
8.d. Compare the conductivity value and/or UF-rate value on the

bargraph display with the conductivity value and/or UF-rate
value shown on the information display.
8.e. Press the arrow below the STOP value and two flashing dots
are indicating the stop conductivity and/or stop UF-rate on the
baragraph displays.
8.f. Compare and verify the conductivity value and/or UF-rate on

the information display.
9. Readjust the TMP alarm limits during treatment in accordance with

the UF rate and the dialyzer’s UF coefficient.
When treatment time equals 0:00, the profiling automatically stops.
CAUTION
When the remaining time is changed after the activation, the profiles
for Na+ and HCO3- will not change. The stop value will not be
reached if the remaining treatment time is decreased.
CAUTION
Note
• The profiling parameters preset in each MODEL remain stored in
AK 200 S memory even when the machine is switched off. Any
preset MODEL can be activated for any treatment.
Note
Activation of profiling with already preset models
1. Press the Profiling button briefly.
2. Select the MODEL: 1, 2 or 3.
3. Activate the profiling mode by pressing the Profiling button for 3

seconds. As soon as blood is detected in the venous line the profiling
mode starts.
Note
• The profiling mode can be switched off at any time during the
treatment. If the mode is switched off, AK 200 S will continue with
the actual values (where it was stopped). If the profiling mode is
switched on again, without having changed parameters, the machine
will continue at the point where it was switched off.
If profiling is activated during treatment, the profile will follow the
predetermined parameters within the remaining time. This is also
valid if a profiling mode has been stopped and is going to be
continued with changed or cancelled parameters.
Note
When treatment time equals 0:00 the profiling function stops.
Verification
4. Verify the sodium, bicarbonate and UF-rate settings:
4.a. Press the Profiling button.
4.b. Select the parameters to be verified and press the arrow below
CHECK on the information display.
The characteristic (L: linear, D: degressive, P: progressive) and the half

time are alternatively shown on the time display.
4.c. Press the arrow below the START value and one flashing dot
on the bargraph display for conductivity will indicate the start
conductivity, if sodium and bicarbonate profiles are to be verified.
One flashing dot on the bargraph display for UF-rate will indicate
the start value for UF-rate, if UF-profile is to be verified.
4.d. Compare the conductivity value and/or UF-rate value on the

bargraph display with the conductivity value and/or UF-rate
value shown on the information display.
4.e. Press the arrow below the STOP value and two flashing dots
are indicating the stop conductivity and/or stop UF-rate on the
baragraph displays.
4.f. Compare and verify the conductivity value and/or UF-rate on

5. Readjust the TMP alarm limits during treatment in accordance with
the UF rate and the dialyzer’s UF coefficient.
CAUTION
The operator has to make sure that the profile chosen is suitable
for the treated patient. The parameters have to be verified prior to
the treatment.
CAUTION
Chapter 8
Hemodiafiltration, low volume

General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:2
Protective system for low volume HDF . . . . . . . . . . . . . . . . . . . . . . . . 8:2
accuracy of the measuring system . . . . . . . . . . . . . . . . . . . . . . . . . . 8:3
Start up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:4
Priming and rinsing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:6
Initiating and starting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:7
Bolus infusion possibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:8
Hemodiafiltration, low volume, single needle, single pump . . . . . . . . . 8:8
Program version 8.xx AK 200 S Operator’s manual - HDF, low volume 8:1
General
The BM 202 offers the possibility to perform infusion of substitution
fluid from external infusion bags using the venous/infusion pump.
A special infusion line for low volume HDF is required in addition
to normal arterial and venous blood lines. See “List of concentrates,
accessories and disposables, for use with the AK 200 S, Gambro
Accessories” in chapter 1.
Protective system for low volume HDF

The system is based on pump speed measuring as well as restrictor
measuring.
If the measured infusion pump speed differs from the calculated speed
an attention alarm is issued to make the operator attentive to the pump
failure.
For the restrictor measuring it is essential that a correct infusion line is
used to obtain the specified level of safety.
The pressure in the expansion chamber changes due to changes of
the infusion flow. This pressure is measured by the system pressure
transducer. The supervision system uses this pressure to calculate the
actual infusion flow and thereby the accumulated infusion volume. This
accumulated volume is compared to the infusion volume calculated from
the set infusion volume and passed treatment time. If there is a difference
there will be an attention alarm to make the operator attentive to e.g. an
obstructed line or an empty infusion bag.
The attention alarms that can occur are:
INFUSION PUMP FAILURE

Deactivate HDF to continue
Or
INFUSION VOLUME DEVIATION

Check cause, press HDF key
For more information about them, see the Attention list in chapter 14.
8:2 AK 200 S Operator’s manual - HDF, low volume Program version 8.xx
accuracy of the measuring system
1. The correct infusion line has to be used.
2. The placement of the infusion bags has to be correct throughout

the treatment.
The lowest part of the bags should be placed 0.5-1 meter above
the venous infusion pump before priming procedure starts. This is
to obtain a correct pressure in the infusion line. The bags have to
stay in this position throughout the treatment. If they are moved
a measurement error will be present until the next taration in the
machine is performed.
3. The bags should be at room temperature. This is important since

the fluid temperature affects the pressure in the expansion chamber.
Start up
Follow the instructions in chapter 4 “Hemodialysis, double needle”
from the beginning to “Priming and rinsing the extracorporeal circuit”.
Continue as follows:
1. Place the infusion bags on the infusion pole 0.5-1 meter above the
venous/infusion pump.
2. Expansion chamber - place the expansion chamber in the expansion

chamber holder. The inlet lines must be facing downwards and the
groove on the expansion chamber must be turned towards the rear
of the machine. Tilt the expansion chamber holder backwards until
it clicks into it’s first position. The expansion chamber will then be
filled to a suitable level during priming procedure.
3. Infusion pump - open the cover of the pump and place the pump
segment inside the pump housing. Turn the pump manually to thread
the pump segment through it. When the pump segment is in place,
close the pump cover.
4. Attach the infusion line coming from the infusion pump, firmly
to the T/Y-connector prior to the drip chamber (see that there are
no closed clamps).
5. System pressure transducer protector - attach the pressure

transducer protector to the system pressure transducer connector.
6. Infusion line clamps - attach the male connector on the

infusion line to the infusion solution (if more than two bags, use
a multiconnector/multidivider). Make sure that the clamps on the
connected lines are open. (And see that the clamps on the lines not
used are properly closed).
Figure 8:1 Infusion line in HDF low volume, set-up
Priming and rinsing
Follow the instructions in chapter 4 “Priming and rinsing the
extracorporeal circuit”
Add the following:
1. Activate HDF by pressing the HDF button for 3 seconds (the button
will light up).
2. Set the priming volume for the infusion line (PRIMING) to at least
200 ml. The priming will start as soon as the Blood pump button is
pressed, or if this is already done, as soon as the value is selected. The
infusion pump will run at the same rate as when bolus is given.
3. When the priming of the infusion line is complete, the

venous/infusion pump stops automatically.
Turn the expansion chamber to it’s upright position. It is not
necessary to adjust the level in the expansion chamber.
Check the infusion line for air. If air is present, prime the line extra
until it is free of air.
If the blood lines were primed/rinsed before the infusion line, readjust
the level in the venous drip chamber if necessary (see position 4 and 5 in
“Priming and rinsing procedure” in chapter 4 in this manual).
Note
• It is not possible to use the level adjustment buttons (left (gray)
area) for adjusting the level in the expansion chamber. There will
be an alarm for system pressure if this is done. The machine will
automatically readjust the level in the expansion chamber during
both priming and treatment.
Note
Initiating and starting
Continue to follow the instructions in chapter 4, “ Initiating dialysis” and
“Start the treatment” and add the following:
1. Briefly press the HDF button and set the total infusion volume (SET).
AK 200 S will now automatically calculate the “total” ultrafiltration
volume, i.e. the infusion volume + patient weight loss.
Note
• The UF volume set via UF volume button gives the net fluid removal
from the patient, i.e. total ultrafiltration - infusion volume.
Note
2. When blood is detected and the Start UF Stop button is pressed, the
HDF procedure starts.
CAUTION
CAUTION
Note
• The HDF procedure start is delayed approximately 15 seconds after
blood is detected. It is also stopped during the automatic calibration
of the UF system.
Note
When the treatment time equals 0:00, the HDF procedure stops
automatically.
Bolus infusion possibility
The machine is equipped with a ”bolus infusion” function to simplify
extra infusion, e.g. in case of a hypotension episode during treatment.
1. Press the HDF button briefly.
2. Select the extra infusion volume (BOLUS). As soon as the value is

selected, the bolus infusion will start and automatically run with a rate
of 50 ml/min until the set infusion volume is given.
The UF rate is automatically decreased to minimum UF rate during
the time when the bolus infusion is given.
Note
• The accumulated bolus infusion volume is displayed below BOLUS.
This volume is not automatically compensated for, thus if the UF
goal is to be achieved, the same amount has to be added to the
UF volume.
Note
Hemodiafiltration, low volume, single needle, single

pump
Follow the instructions for single needle with one blood pump in chapter
5 and the instructions for low volume HDF in chapter 8, in this manual.
Chapter 9
BVS - Blood Volume Sensor

General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9:2
∆BV text information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9:3
Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9:4
Graphs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9:5
BVS ON/OFF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9:6
BVS Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9:6
BVS On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9:7
Program version 8.xx AK 200 S Operator’s manual - BVS 9:1
General
CAUTION
Medical decisions must not be based only on information from BVS,
as there are many other factors that should be taken into account.
There is no direct, independent supervision of the BVS.

CAUTION
The BVS measures changes in the blood volume of the patient

continuously during the treatment. 5 minutes after the priming detector
has detected blood the BVS will acquire a reference value, 0%. Blood
volume changes (∆BV) during the treatment will be related to the
reference value. If the patient’s blood volume decreases this will result in
a negative percentage. Conversely an increased blood volume will show
as a positive percentage.
During the function check of the blood monitor the BVS performs an
self test, provided the BVS is in its on-position. The self test has to be
performed with an empty cuvette holder. Therefore, the cuvette must be
outside the cuvette holder until the function check of the blood monitor
has been completed (flashing Priming button).
Note
• The blood flow rate has to be above a certain rate and the
Hemoglobin value of the patient has to be above a certain value
in order for a correct BVS reference value to be obtained. If not,
attention alarms will be generated 30 minutes after treatment start.
See the “Technical data and specifications” chapter for further details.
If the blood flow rate decreases below the specified value after
the BVS reference value has been obtained, no ∆BV value will be
displayed (--- will be shown).
• If the BVS is turned on when priming has started, no self test will
take place. As a consequence the accuracy may be outside the
specified range.
Note
9:2 AK 200 S Operator’s manual - BVS Program version 8.xx
The BVS is handled through the information display. Press the BVS button
and the information display will light up. Data and parameters are entered
using the Set knob.
The information display is capable to show the following graphs:
• relative blood volume (∆BV) from the start of the measurement
• UF rate from the start of the measurement
• conductivity of the dialysis fluid from the start of the measurement
• systolic blood pressure (if BPM has been installed) from the start of
the measurement, the latest measured value before treatment start
will be shown at time 0
The ∆BV is also presented as text information on the information display

(bottom, left).
Figure 9:1 BVS, relative blood volume graph
Note
• If the BVS button is pressed when no BVS is installed, the information
display will remain dark.
Note
BV text information
The actual value of the ∆BV is presented as text information in the lower
left corner. The range is from -40% to +10%. If the value is below -40%
this is shown as “- -“, over +10% is shown as “++“ and “currently no
data“ is shown as “....“.
Alarm
An alarm is issued when the relative blood volume is outside the set alarm
limit. The alarm limit is adjustable at any time (default level presettable).
The alarm function can be turned on or off (presettable).
Figure 9:2 BVS, relative blood volume graph
To set an alarm limit, press the left Arrow button and turn the Set knob. It is
possible to set the alarm limit in the range from -40% to -1%. To turn
the alarm off, turn the Set knob until OFF is shown on the information
display. OFF are fixed end points at both ends of the alarm range (OFF,
-40%, -39%,...-2%,- 1%, OFF) which cannot be passed by turning the
Set knob further.
When an alarm is being issued the BVS button will light up with steady
light and the Mute button will flash. There will be a soft buzzer signal. The
BVS button then has to be pressed to show the information display.
Graphs
It is possible to choose which combination of graphs to be shown on the
In addition to the ∆BV graph, which is always shown, the graphs that
can be selected are:
• UF rate
• conductivity in dialysis fluid
• systolic blood pressure (if BPM has been installed)
Figure 9:3 BVS, combination of graphs
To select which combination of graphs to show, press the middle

Arrow button and turn the Set knob. The graphs text information will be:
• ∆BV = relative blood volume
• ∆BV/UFr = relative blood volume and UF rate
• ∆BV/COND = relative blood volume and conductivity
• ∆BV/UF/C = relative blood volume, UF rate and conductivity
• ∆BV/Psys = relative blood volume and systolic blood pressure
• ∆BV/UF/P = relative blood volume, UF rate and systolic blood

pressure
The current setup will remain throughout the treatment. If the same
setup is to be used for more treatments, a setup can be preset.
BVS ON/OFF
Pressing the right Arrow button, allows two options. These are BVS ON
and BVS OFF. This can be performed any time during the treatment.
By turning the Set knob it is possible to select the functions:
• OFF
• ON
Note
• The BV value is not available until the reference value has been
acquired.
Note
BVS Off
Figure 9:4 BVS, graphs without relative blood volume graph
Turning the BVS off will stop all measurements. If the BVS button is
pressed while the BVS is turned off, the information display will show the
selected number of graphs, except the ∆BV (see figure above).
BVS On
The BVS is turned on by turning the Set knob to ON. The effect will
depend on in which context this is done and on the previous history
during treatment. If the BVS is turned on before the reference value
has been acquired, the information display will change from the OFF
display above to the following example. Reference value will be acquired
as normal.
Figure 9:5 BVS turned on before the reference value has been acquired
If the BVS is turned on after the reference value would have been
acquired in a normal treatment, the information display will change from
the OFF display to an ON display. The reference value will be acquired
as soon as possible. The information display will show the ∆BV graph
but it will not be related to the treatment start.
Figure 9:6 BVS, the reference value not related to the treatment start
Note
• If the BVS is turned on after the reference value would have been
acquired in a normal treatment, the reference value will not be related
to the treatment start.
Note
If the BVS is turned on again in a treatment during which the reference

value has been acquired before, the BVS display may look like this:
Figure 9:7 BVS, interrupted relative blood volume graph
The ∆BV data which have been acquired earlier in treatment have been
stored for later display.
Chapter 10
BPM - Blood Pressure Monitor (option)

General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10:2
Patient factors which affect readings . . . . . . . . . . . . . . . . . . . . . . . . . . 10:3
Handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10:5
The BPM screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10:6
BPM button pressed once . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10:6
BPM button pressed twice . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10:7
Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10:8
Alarm limits setting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10:8
Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10:9
Start/Stop . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10:10
Start . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10:10
Stop . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10:10
Program version 8.xx AK 200 S Operator’s manual - BPM 10:1
General
The Blood Pressure Monitor measures blood pressure and pulse rate.
It is possible to use the BPM as soon as the machine is started. All
measurements which are taken 30 minutes before the priming detector
detects blood will be displayed as previously measured values on the
The BPM cuff and cuff hose are protected against the discharge from a
defibrillator (Type BF, defibrillator proof).
CAUTION
Do not touch the BPM cuff or cuff hose when a defibrillator is being
discharged, as doing so may cause electric shock.
In the event of accidental wetting of the BPM cuff or cuff hose

connections, wipe immediately to prevent moisture from entering
the machine.
No protective means for burn of the patient are provided when the
BPM is used together with high frequency (HF) surgical equipment.
CAUTION
The line from the cuff (cuff hose) is attached to the back of the AK 200 S
(see "Rear of the machine" in chapter 2).
The cuff is available in different designs and sizes, see "List of
concentrates, accessories and disposables, for use with the AK 200 S"
in chapter 1.
The cuff and the cuff hose can be ordered from your Gambro
representative.
It is important to use proper cuff size for accurate measurements. Use the
circumference of the patient’s arm to determine cuff size. If the bladder
is too wide, the blood pressure reading will be erroneously low; if it is too
narrow, the reading will be erroneously high. Apply the cuff snugly so
that one finger can fit between the cuff and the patient’s arm.
More information about how to choose the right cuff size, how to
connect the cuff to the cuff hose and the cuff hose to the machine can be
read in the “package insert” leaflet which is enclosed to the cuff and cuff
hose. The “package insert” leaflet also contains information about how
to properly apply the cuff on the patients arm.
10:2 AK 200 S Operator’s manual - BPM Program version 8.xx
Patient factors which affect readings
Excess patient movement can interfere with readings. Ensure that the
patient is not moving during readings, just as one would with manual
readings.
Avoid applying external pressure to the cuff during readings.
Some arrhythmias may cause pressure fluctuations that make obtaining

readings more difficult. If difficulty obtaining readings occurs in the
presence of arrhythmia, blood pressure should periodically be verified
by another method.
• Do not apply a blood pressure cuff to a limb with an access, e.g.

fistula or graft.
• Do not apply a blood pressure cuff to a limb being monitored with

a pulse oximetry sensor.
• Do not apply a cuff to a limb that has restricted blood flow.
• Avoid applying a cuff to a limb that has an intravenous line in place.
CAUTION
Check that the blood circulation in the arm is not affected due to
blood pressure measurements.
The Blood Pressure Monitor must be used only for adult patients
or for children with a pediatric cuff and not for infant or neonatal
patients.
The manufacturer advises the user that the information originating

from the Blood Pressure Monitor cannot be used alone as unique
source of information to induce any therapeutic or pharmacological
actions.
CAUTION
Handling
The BPM is handled using the BPM button, the Arrow buttons and the
Set knob, see “Operator’s panel” in the “Controlling the machine - general
guidelines” chapter.
When the BPM button is pressed, once or twice, the BPM screens will be
shown on the information display. BPM button, steady light; indicates that
a measurement check is in progress.
BPM button, flashing light; indicates that an attention alarm which needs
confirmation has been generated. Confirm by pressing the flashing
BPM button.
When a measurement check is in progress, the BPM button will light up

(steady light) and the current pressure in the cuff will be displayed in
the bottom left corner of the information display. At the top of the
information display the measurement values will be presented as “---”
instead of numbers (not valid for continuous mode). As soon as the
measurement check is finished the values for blood pressure and pulse
rate will be presented beside the clock symbol which indicates the time
for when the measurement check was performed.
The cuff pressure will be maximum 180 mmHg the first time the blood
pressure is being measured when a blood pressure measurement check
is carried out. If there are difficulties for the BPM to obtain the correct
values there will be two re-measurements with higher cuff pressure. If
the measurement check still fails there will be an attention alarm to guide
the operator to take correct actions (see chapter 14). If the measurement
check was successfully performed, the cuff pressure will be maximum
50 mmHg above the latest measured systolic blood pressure for the
following measurement checks in the sequence.
Note
• If the BPM button is pressed when no BPM has been installed, the
information display will remain dark.
Note
The BPM screens
BPM button pressed once

When the BPM button is pressed once, the latest measured values for
systolic, diastolic, mean blood pressure and pulse rate will be shown as
numerical values at the top of the information display. The clock symbol
indicates the time for when the measurement check was performed.
Previously measured values for systolic, diastolic, mean blood pressure
and pulse rate will be shown as lines in the graph. It is also possible to
start and stop measurement checks, choose mode and set alarms on this
screen, see information further on in this chapter for each activity.
• The numerical value for the latest systolic blood pressure is presented
in white. A white point marks every measurement check and a white
line connects the points.
• The numerical value for the latest diastolic blood pressure is presented
in yellow. A yellow point marks every measurement check and a
yellow line connects the points.
• The numerical value for the latest mean blood pressure is presented
in green. A green point marks every measurement check and a green
line connects the points.
• The numerical value for the latest pulse rate is presented in red and is
marked with this symbol . A red point marks every measurement
check and a red line connects the points.
Figure 10:1 BPM, screen with latest measured values and graph
The horizontal axis shows the time. The length of the axis equals the
treatment time +10 min rounded off to the next half hour. Minimum
length of the axis is 3 hours and maximum 10 hours. The red line shows
elapsed treatment time.
The vertical axis to the left will show mmHg for the blood pressure. The
grading will be set to 25 - 250 mmHg, with a marker on every 25 mmHg.
The vertical axis to the right will show beats/min for the pulse rate and
is marked with this symbol . The grading will be set to 25 - 175
beats/min with a marker at every 25 beats/min.
If a measurement check fails or is outside the set interval, there will be

an interruption of the line in the graph. However, in the event that a
measurement check is outside the set interval, the value will be shown as
numerical information at the top of the information display.
It is possible to move between the points on the lines in the graph by

using the Set knob in order to read off previously measured values. Turn
the Set knob anticlockwise and a light blue horizontal line will be shown,
indicating which measurement check is shown. The numerical values for
this measurement check will now be shown at the top of the information
display. This can be done in any BPM mode, also when a measurement
check is in progress.
BPM button pressed twice

When the BPM button is pressed twice, the 8 latest measured values for
systolic, diastolic, mean blood pressure and pulse rate will be shown
as numerical values, starting with the latest values at the top of the
screen. It is also possible to start and stop measurement checks, choose
time intervals for automatic mode and set alarms on this screen, see
information further on in this chapter for each activity. indicates
pulse rate, indicates the time for when the measurement check was
performed.
Figure 10:2 BPM, screen with the 8 latest measured values
Alarm
The BPM alarm function can be set to on or off by pressing the lit
Arrow button below ALARM. Choose ON or OFF by using the
Set knob.
When the alarm function has been set to ON, attention alarms are
generated when a value is outside the set alarm limit. The BPM button will
flash simultaneously. When the attention alarm message has been read,
confirm by pressing the flashing BPM button and the BPM screen will
be shown. The measured numerical values outside the set alarm limits
will be flashing.
Alarm limits setting

To set an alarm limit, press the BPM button once or twice. Press the lit
Arrow button below ALARM and turn the alarm function to ON by using
the Set knob. Press the Arrow button a second time and the alarm limits will
now be shown at the top of the information display.
Figure 10:3 BPM, setting the alarm limits
A white marker will point at the alarm limit that can be adjusted, set the
alarm limit by using the Set knob. Pressing the left Arrow button once more
will move the marker to the next alarm limit, set the alarm limit by using
the Set knob. Repeat the procedure until all alarm limits have been set.
Alarm limits can be adjusted at any time during treatment. There is also
the possibility to preset the alarm limits.
The alarm ranges are:

Systolic Diastolic Mean Pulse rate
Low alarm limit 60-250 40-200 45-235 40-180
High alarm limit 60-250 40-200 45-235 40-180
Mode
When the lit Arrow button below MODE is pressed it is possible to choose
BPM mode. Set the desired mode by using the Set knob. The possibilities
are manual (MANUAL ), automatic (AUTO), continuous (CONT) or off
(OFF ).
• Manual; in this mode a measurement check has to be started

manually when desired. Press the lit Arrow button below START and
a measurement check will start. START will now change to STOP,
and consequently, the measurement check will stop if the Arrow button
is pressed a second time. When a measurement check is started
manually the Hold button will light up and the information display
will remain lit.
• Automatic; in this mode measurement checks will take place

automatically at set time intervals. A measurement check can always
be started manually between the set intervals for the measurement
checks by using the lit Arrow button below START. To set the time
intervals press the BPM button twice, then press the lit Arrow button
below INTERVAL and set the time intervals by using the Set knob.
It is possible to set the time intervals between 3 - 60 minutes. The
time until the next measurement check in the sequence is going to be
performed is shown below NEXT on the screens in this mode.
• Continuous; in this mode measurement checks will take place

continuously for 5 minutes. Start the measurement check sequence by
pressing the lit Arrow button below START. START will now change
to STOP, and consequently, the measurement checks will stop if the
Arrow button is pressed a second time. As soon as continuous mode
has been started, the second screen will automatically be displayed.
Previously measurement values will be shown at that time and values
measured for the continuous mode will be added as soon as a new
measurement check has been performed. The second screen will be
shown during the period of time for when the mode is active.
• Off; the blood pressure monitor is turned off (OFF).
Note
• It is always possible to stop a blood pressure measurement check in
progress, in any mode, by using the lit Arrow button below STOP.
• After treatment, when the cuff is removed from the patient, the blood
pressure measurement will continue as set when automatic or
continuous mode is chosen. Manual mode (MANUAL) or off (OFF)
has to be chosen to stop measurement. It is still possible to read
off previously performed measurement check values by pressing
the BPM button once or twice.
Note
Start/Stop
Press the BPM button once in order to light up the information display.
Start
To start a measurement check manually press the lit Arrow button below
START.
When a measurement check is in progress the current pressure in the cuff

will be displayed in the bottom left corner of the information display. At
the top of the information display the values will be presented as "---"
instead of numbers (not valid for continuous mode). As soon as the
measurement check has finished the new values will be presented.
Figure 10:4 BPM, measurement check in progress
Stop
To stop a measurement check in progress, press the lit Arrow button
below STOP. The measurement check will be stopped and the cuff will
be deflated.
Chapter 11
Diascan
General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:2
Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:2
How the measuring process is performed by the machine . . . . . . . . . . 11:2
Glossary of Diascan parameters and key terms . . . . . . . . . . . . . . . . . . 11:3
Precautions before use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:4
Handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:5
Screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:5
The first screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:6
Measurement mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:6
Alarm limit for clearance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:6
Measurement result values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:7
The second screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:8
Distribution volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:8
Distribution volume calculation using the Watson formula . . . . 11:9
Forecast . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:10
Target . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:10
Alarm limit for Kt/V . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:10
Measurement result values when distribution volume has not been
set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:11
Second screen symbol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:11
Measurement result values when distribution volume has been set . 11:12
The third screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:13
Latest measured values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:13
Accumulated and forecast values . . . . . . . . . . . . . . . . . . . . . . . . . . 11:13
Time to target . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:14
Third screen symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:14
Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:15
Clearance alarm limit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:15
Kt/V alarm limit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:15
Step-by-step instructions for measuring clearance and Kt/V . . . . . . . . . . 11:16
Single clearance measurement check . . . . . . . . . . . . . . . . . . . . . . . . . . 11:16
Continuous measuring of clearance . . . . . . . . . . . . . . . . . . . . . . . . . . . 11:18
Single Kt/V and clearance measurement check . . . . . . . . . . . . . . . . . . 11:20
Continuous measuring of Kt/V and clearance . . . . . . . . . . . . . . . . . . . 11:22
Program version 8.xx AK 200 S Operator’s manual - Diascan 11:1
General
Application
The Diascan can be used for:
• Clearance measurement (K) in order to read off the current dialysis

efficiency for the on going treatment.
• Dialysis dose measurement (Kt or Kt/V) in order to check that

the prescribed dialysis dose is being maintained, which provides
quality assurance for the treatments.
• Kt/V target supervision, which means that the machine constantly

calculates if the desired and minimum values for Kt/V, set by the
operator for each individual patient, can be reached at treatment end.
If not, the operator will be immediately notified during treatment.
The measurement checks can be performed one at a time when required,

or continuously at set intervals during treatment.
If Kt/V measurement is required, a distribution volume (VOLUME) has

to be set before the measurement check takes place. The distribution
volume is patient-related (based on the patients dry weight) and has to
be properly estimated and set by the operator of the machine in order to
obtain a correct Kt/V value.
How the measuring process is performed by the

machine
With the use of a conductivity sensor, placed after the dialyzer in the fluid
path, it is possible to measure clearance during treatment.
A measurement check is performed in two phases.
During the first measurement phase (base line phase) data from the
sensor is collected for some minutes.
The second phase (step phase) begins with an increase or a decrease

in the conductivity level. This is followed by data collection for some
minutes. If there will be an increase or a decrease is dependent on the
relation of the conductivity levels in the dialysis fluid before and after the
dialyzer in the first phase. This is to ensure that the patient’s sodium
balance remains as neutral as possible.
When the second phase is complete the conductivity level is returned to

the set value and the clearance calculation is performed. The calculation
is based on the measured difference between the conductivity levels in
the first and second phases.
11:2 AK 200 S Operator’s manual - Diascan Program version 8.xx
Glossary of Diascan parameters and key terms
Parameters:
K is clearance. Clearance tells the operator how much blood, in ml/min,
is cleaned of urea after it has passed the dialyzer. This value can be
compared with the current blood flow rate at that time.
Kt is clearance multiplied by elapsed treatment time. This value (in litres)

can be compared with the accumulated blood volume (in litres) achieved
since treatment start.
Kt/V is a calculation done by the machine depending on the set

distribution volume entered by the operator of the machine.
Qb is blood flow rate in ml/min.
Na+ is the estimated sodium concentration in serum calculated by the

machine with respect to serum conductivity.
Key terms:
Diascan is the commercial name for a clearance sensor.
Distribution volume is the urea distribution volume in litres (water in

the body), estimated for the individual patient, based on the patient’s
dry weight. The estimation is based on certain formulae used for this
purpose, chosen by the prescribing physician responsible for the patient.
The distribution volume has to be set by the operator of the machine in
order for a correct Kt/V value to be obtained.
Forecast in this context, is a machine-calculated prediction of the Kt

or/and Kt/V value to be achieved at treatment end.
Target in this context, is the desired Kt/V value set by the operator that
is to be achieved at treatment end.
Precautions before use
CAUTION
Medical decisions must not be based only on information from the
Diascan, as there are many other factors that should be taken into
account.
CAUTION
The Diascan function can be used in HD mode, double needle treatment.

It can be used when performing single needle treatment but the accuracy
of the machine measurement may be compromised. The same is valid for
profiling of sodium and bicarbonate, whereas the measurement accuracy
is not affected when using profiling of ultrafiltration rate. If profiling is
active, the profiling values will be frozen during the Diascan step.
If the Diascan is activated in Isolated UF mode, the machine will generate

an attention alarm telling the operator that the Diascan function is not
available.
An attention alarm is generated if a treatment parameter (see below) is

changed at the same time as a measurement check is in progress, and it
will not be possible to change the parameter. The treatment parameters
that cannot be changed during an ongoing measurement check are:
- sodium and bicarbonate (conductivity)
- temperature
- dialysis fluid flow
- UF volume
- profiling settings
- isolated UF activation
If possible, wait until the check is complete or turn off the Diascan in
order to change the parameter.
Another attention alarm is generated when one of the following is done

at the same time as a measurement check is in progress:
- the blood flow rate is changed
- the Blood pump button is pressed
- the Start UF Stop button is pressed
- the Fluid bypass button is pressed
- a treatment alarm that produce dialysis fluid bypass or blood pump
stop is generated.
In this case the measurement check is interrupted. The attention alarm is

to be confirmed by pressing the flashing Kt/V button and the machine will
automatically reschedule measuring as soon as possible.
Note
• The blood flow rate and the dialysis fluid flow rate have to be set
within certain ranges in order for correct Diascan measuring results
to be obtained. See the “Technical data and specifications” chapter
for further details.
Note
Handling
The Diascan is handled using the Kt/V button, the Arrow buttons and the
Set knob, see “Operator’s panel” in the “Controlling the machine - general
guidelines” chapter.
When the Kt/V button is pressed the Diascan screens will be shown
on the information display. Kt/V button, steady light; indicates that a
measurement check is in progress.
Kt/V button, flashing light; indicates that an attention alarm which needs
confirmation has been generated. Confirm by pressing the flashing
Kt/V button.
Screens
The Diascan shows three different screens on the information display
depending on whether the Kt/V button is pressed once, twice or three
times. The screens change in sequence every time the Kt/V button is
pressed.
EN1115
Figure 11:1 Diascan screens, without set distribution volume
If the distribution volume (VOLUME) has been set by the operator, the
second and third screen will change automatically and it will be possible
to set a Kt/V target value (TARGET) and a Kt/V alarm limit (LIMIT).
EN1161
Figure 11:2 Diascan screens, set distribution volume
The first screen
The Diascan measurement mode is to be set on this screen and, if desired,
an alarm limit for clearance.
Measurement result values for K, Kt (or Kt/V), Na+, Qb and elapsed
treatment time are displayed when measurement checks have been
performed.
Press the Kt/V button once and the first Diascan screen will be shown:
Figure 11:3 First Diascan screen
Measurement mode
The Diascan is activated by pressing the lit Arrow button below Diascan.
When Diascan is flashing, turn the Set knob clockwise to choose a single
measurement check or continuous checks at intervals (the intervals
are 15, 30 or 60 minutes). If desired, it is also possible to deactivate the
Diascan by turning the Set knob anticlockwise to (OFF).
Alarm limit for clearance

The alarm limit for minimum clearance is to be set by pressing the lit
Arrow button below K LIMIT until the text is flashing. Set a proper alarm
limit by turning the Set knob. For further information; see “Alarms,
Clearance alarm limit” in this chapter.
Measurement result values
Figure 11:4 First Diascan screen with measurement result values
When a measurement check has been performed, measurement result

values are shown as numerical values as well as graphs.
• Red graph on the base line of the diagram shows elapsed treatment
time (t) in hours.
• Green dots and graph in the diagram show all measured serum
sodium (Na+) values in mmol/l during treatment.
• Red graph in the diagram shows blood flow rate (Qb) in ml/min.
• The numerical value below K shows the latest measured clearance

value. White dots and graph in the diagram show all measured
clearance (K) values in ml/min during treatment.
• The numerical value below Kt (or Kt/V if distribution volume has

been set in the second screen), shows the accumulated Kt (or Kt/V)
value that has been achieved since treatment start.
Failed measurement checks are indicated by the symbol --- below K.

Broken line graphs for clearance (K) and serum sodium (Na+) will also be
displayed in this case.
The second screen
On this screen the distribution volume is to be set if Kt/V measurement
is desired. It is also possible to set a target value and an alarm limit
for Kt/V. Forecast and measurement result values for accumulated Kt
(or Kt/V if distribution volume has been set) will be displayed when
measurement checks have been performed. The screen will automatically
change when distribution volume has been set.
Press the Kt/V button twice and the second Diascan screen will be shown:
Figure 11:5 Second Diascan screen
Distribution volume
The operator is requested to set a distribution volume in litres, estimated
for the individual patient, in order to obtain a correct Kt/V value from
the Diascan. The distribution volume has to be properly estimated and set
by the operator. The calculation of Kt/V done in the machine is entirely
dependent on the value for the individual patient being the correct one.
For further information; see “Glossary of Diascan parameters and key
terms” in this chapter.
When the lit Arrow button below VOLUME is pressed the text will flash
and --- (zero) will be shown on the information display. The volume is
now to be set by using the Set knob, see below. If desired, it is possible
for the machine to carry out a distribution volume calculation using the
Watson formula, see next section for instructions.
After the lit Arrow button has been pressed, once the Set knob is turned
clockwise, 40 l is the default starting point value . Adjust the value as
necessary. If desired, set the value to zero (---) by turning the Set knob
anticlockwise, and the machine will consequently display only the Kt
value.
When a measurement check has been performed, the screen will

show different measurement result values dependent on whether the
distribution volume has been set or not. The screen will automatically
change.
Distribution volume calculation using the Watson formula
It is possible for the machine to carry out a distribution volume
calculation, displayed in litres, using the Watson formula. In order for the
machine to provide a value, gender, weight, height and age (if male) of the
particular patient must be entered into the machine. When the calculation
has been done, a (W) will be displayed beside the distribution volume
value provided, showing that the value has been calculated by the machine.
After the lit Arrow button below VOLUME has been pressed, the text will
flash and --- (zero) will be shown on the information display. Immediately
turn directly the Set knob anticlockwise and the Watson screen will be
displayed as below.
Figure 11:6 The Watson screen
Confirm entering the calculation procedure by pressing the Arrow button

below Continue and the screen will change. Gender, Male or
Female, is to be selected first by turning the Set knob. The selected
alternative will flash; press the Arrow button below Continue to confirm
selected alternative. The screen will then automatically change and patient
weight is to be selected.
Enter patient weight and height in a similar way, as above. If Male

has been selected, patient age is to be entered in the same way too. If
necessary, cancellation can be done by pressing the Hold button during
the procedure.
When all data have been entered, the screen will change and it will take a
few seconds until it changes again and returns to the original screen. The
distribution volume value, in litres, calculated by the machine according
to the Watson formula, will be shown below VOLUME. A W in brackets is
shown beside the value indicating that the value has been calculated by
the machine. Note that if the distribution volume value (VOLUME) is
changed, the (W) beside the value will disappear.
If a new calculation is desired, turn the Set knob anticlockwise until ---
(zero) appears, and it will be possible to redo the procedure from the start.
Forecast
The numerical value below FORECAST is a calculation of the Kt or Kt/V
value that is estimated to be obtained when the treatment is complete. If a
distribution volume (VOLUME) has been set, this Kt/V forecast value will
be calculated by the machine and automatically be shown as soon as the
first measurement check has been performed. If a distribution volume has
not been set, the machine will only calculate and display the Kt forecast
value. The calculated forecast value (Kt or Kt/V) is adjusted after every
successfully performed measurement check throughout the treatment.
Figure 11:7 Second Diascan screen with set distribution volume
Target
When the lit Arrow button below TARGET is pressed the text will flash
and it is possible to set a desired dialysis dose target value (Kt/V) that
is to be achieved at the end of treatment by using the Set knob. The target
value for Kt/V can be set between OFF and 2.0.
When the Kt/V target value has been set, the machine calculates the
time needed to reach the target. This time to target is displayed on the
third screen.
Alarm limit for Kt/V

The alarm limit for minimum Kt/V is to be set by pressing the lit
Arrow button below LIMIT until the text is flashing. Set a proper alarm
limit by using the Set knob. For further information; see “Alarms, Kt/V
alarm limit” in this chapter.
Measurement result values when distribution volume has not
been set
Figure 11:8 Second Diascan screen with measurement result values, distribution
volume not set
time (t) in hours.
• Blue graph in the diagram shows the accumulated Kt value that has
been achieved since treatment start. The graph continues as a dashed
line until it reaches the goal flag indicating the forecast Kt value at
treatment end.
• The numerical value below FORECAST shows the Kt value that is

estimated to be obtained when the treatment is complete.
Second screen symbol

the goal flag indicates end of treatment.
Measurement result values when distribution volume has been
set
Figure 11:9 Second Diascan screen with measurement result values, set distribution
volume
time (t) in hours.
• White graph in the diagram shows the accumulated Kt/V value

that has been achieved since treatment start. The graph continues as
a dashed line until it reaches the goal flag indicating the forecast
Kt/V value at treatment end.
• The numerical value below FORECAST shows the Kt/V value that
is estimated to be obtained when the treatment is complete.
• If the alarm limit for Kt/V has been set, it is indicated by a red dot in
the vertical axis of the diagram and the axis will be red below the dot.
• If a target value for Kt/V has been set, it is indicated in green in

the vertical axis of the diagram.
• If target value and alarm limit for Kt/V have been set, the difference
between the two values is shown in yellow in the vertical axis of
the diagram.
Second screen symbol

the goal flag indicates end of treatment.
The third screen
The third screen summarises measured and calculated parameters during
treatment, shown as numerical values as soon as measurement checks
have been performed.
It is also possible to set or adjust the distribution volume and consequently
the target value and the alarm limit for Kt/V, if this has not been done
in the second screen.
The screen will automatically change, as the second screen does, when
distribution volume has been set.
Press the Kt/V button three times and the third Diascan screen will be
shown:
Figure 11:10 Third Diascan screen
Latest measured values

The latest measured values for clearance (K) and serum sodium (Na+) are
shown below date and time.
The clock symbol indicates the time when the latest measurement
check was performed.
Accumulated and forecast values

The accumulated value for Kt, obtained since treatment start, is shown
next.
The small arrows indicate the calculated Kt forecast value that is
estimated to be obtained when the treatment is complete. The same value
is also shown below FORECAST as in the second screen. However,
if distribution volume (VOLUME) has been set, the accumulated and
forecast values for Kt/V are also shown directly underneath. In this case
the value below FORECAST changes to the Kt/V forecast value.
Time to target
When a target value for Kt/V (TARGET) has been set in the second
screen (or in this screen), the machine will show an estimate of the
treatment time needed in order to reach the desired Kt/V target value.
Time to target will be calculated by the machine and automatically shown
as soon as the first measurement check has been performed indicated by
this symbol .
If time to target is estimated to be within the remaining treatment time set,
the time will be displayed in green and a happy smiley symbol appears .
If not, the time will be displayed in red indicating that the treatment must
be extended for the desired Kt/V target value to be reached. Note that
an attention alarm will not be generated in this case.
Third screen symbols

The happy smiley shows that the forecast remaining treatment time to
reach the Kt/V target value is within the remaining set treatment time.
The clock indicates time.
This symbol indicates time to target, i.e. the time needed to reach the
Kt/V target value set by the operator.
The arrows indicates a forecast value.
A dashed line; ---- indicates that there are no values measured or

calculated to be displayed.
Alarms
Clearance alarm limit

The alarm limit for clearance is the lowest acceptable clearance value
measured during treatment.
When the lit Arrow button below K LIMIT (first screen) is pressed the
text will flash. Set a proper alarm limit by using the Set knob. Once the
Set knob is turned the starting point value is 50% of the current blood
flow rate. Adjust the value as necessary.
If desired, set the alarm limit to OFF by turning the Set knob anticlockwise.
If the measured clearance value is below the alarm limit set, an attention
alarm will be generated:
CLEARANCE TOO LOW
Check cause, adjust treatment parameters to increase clearance or adjust

the alarm limit for clearance as above.
Kt/V alarm limit

The alarm limit for Kt/V is the lowest acceptable Kt/V forecast value
(calculated by the machine), that is to be accepted when the treatment is
complete. The value that is to be set is the minimum Kt/V value that has
to be achieved when the treatment has finished.
When the lit Arrow button below LIMIT (second screen) is pressed the
text will flash. Set a proper alarm limit by using the Set knob. If desired,
set the alarm limit to OFF by turning the Set knob anticlockwise.
If the Kt/V forecast value, estimated at that time to be obtained when
the treatment is complete, is below the Kt/V alarm limit set, an attention
alarm will be generated:
Kt/V FORECAST TOO LOW
Check cause, adjust treatment parameters or adjust the alarm limit for
Kt/V as above.
Step-by-step instructions for measuring
clearance and Kt/V
Single clearance measurement check
Procedure
1. Press the Kt/V button once and the first Diascan screen will be shown.
2. Press the lit Arrow button below Diascan; the text will flash.
3. Turn the Set knob clockwise one step and SINGLE will be shown.
A single measurement check is now activated.
Figure 11:11 Diascan, activated single measurement check
The single clearance measurement check will be performed on an

appropriate occasion chosen by the machine. The occasion chosen
is dependent on when the self-calibrations of the machine are to be
performed.
The Kt/V button will light up (steady light) during the period of time
when the measurement check is being performed.
When the measurement check has been performed the Diascan will
automatically be turned to OFF. It is possible to repeat the procedure at
any time during treatment.
Result
The measurement result values are summarised and displayed as numerical
values on the third Diascan screen. Read off the measurement result
values there or, if further information is desired, on the corresponding
Diascan screen, by pressing the Kt/V button once, twice or three times.
Refer to information below “The first screen”, “The second screen” and
“The third screen” in this chapter.
Note
• To ensure a correct result a single clearance measurement check
should be activated no later than 30 minutes before discontinuing
treatment. This is in order to have time to obtain a measurement
result.
Note
Continuous measuring of clearance
Procedure
3. Turn the Set knob clockwise step by step until desired intervals
for the measuring are shown (15, 30 or 60 minutes). Continuous
measuring is now activated at set intervals.
4. If an alarm limit for clearance is required, press the lit Arrow button
below K LIMIT; the text will flash. Turn the Set knob clockwise until
a suitable value is shown and the alarm limit is set. For further
information; see "Alarms, Clearance alarm limit", in this chapter.
Figure 11:12 Diascan, activated continuous measuring
The first clearance measurement check in the sequence will be performed

on an appropriate occasion chosen by the machine. The occasions
chosen are dependent on when the self-calibrations of the machine are
to be performed.
The Kt/V button will light up (steady light) during the period of time when
the measurement checks are being performed.
Result
Single Kt/V and clearance measurement check
Procedure
3. Turn the Set knob clockwise one step and SINGLE will be shown.
A single measurement check is now activated.
Figure 11:13 Diascan, activated single measurement check
4. Press the Kt/V button a second time and the second Diascan screen
will be shown.
5. Press the lit Arrow button below VOLUME; the text will flash and ---
(zero) will be shown. The distribution volume is now to be set to a
correct value for the individual patient, using the Set knob. If desired,
it is possible for the machine to carry out a distribution volume
calculation using the Watson formula, see "The second screen",
"Distribution volume calculation using the Watson formula" in this
chapter for instructions.
If the value is to be set manually, once the Set knob is turned clockwise,
40 l is the default starting point value . Adjust the value as necessary.
Note that the distribution volume has to be properly estimated for
the individual patient. The calculation of Kt/V done in the machine
is entirely dependent on the value for the individual patient being
the correct one. For further information; see "Glossary of Diascan
parameters and key terms" in this chapter.
Figure 11:14 Diascan, distribution volume set
The single Kt/V and clearance measurement check will be performed on

an appropriate occasion chosen by the machine. The occasion chosen
is dependent on when the self-calibrations of the machine are to be
performed.
The Kt/V button will light up (steady light) during the period of time
when the measurement check is being performed.
When the measurement check has been performed the Diascan will
automatically be turned to OFF. It is possible to repeat the procedure at
any time during treatment.
Result
Note
• Changes in treatment parameters (above all blood flow rate) affect
measured clearance (K) values obtained during treatment and
consequently the calculated Kt/V result. If the Kt/V calculation at
treatment end is based on few clearance results, or only one, check
that these results are relevant for the complete treatment. This is in
order to ensure that the Kt/V value is a relevant one.
• To ensure a correct result a single Kt/V and clearance measurement

check should be activated no later than 30 minutes before
discontinuing treatment. This is in order to have time to obtain a
measurement result.
Note
Continuous measuring of Kt/V and clearance
Procedure
3. Turn the Set knob clockwise step by step until desired intervals
for the measuring are shown (15, 30 or 60 minutes). Continuous
measuring is now activated at set intervals.
4. If an alarm limit for clearance is required, press the lit Arrow button
below K LIMIT; the text will flash. Turn the Set knob clockwise until
a suitable value is shown and the alarm limit is set. For further
information; see "Alarms, Clearance alarm limit", in this chapter.
Figure 11:15 Diascan, activated continuous measuring
5. Press the Kt/V button a second time and the second Diascan screen
will be shown.
6. Press the lit Arrow button below VOLUME; the text will flash and ---
(zero) will be shown. The distribution volume is now to be set to a
correct value for the individual patient, using the Set knob. If desired,
it is possible for the machine to carry out a distribution volume
calculation using the Watson formula, see "The second screen",
"Distribution volume calculation using the Watson formula" in this
chapter for instructions.
If the value is to be set manually, once the Set knob is turned clockwise,
40 l is the default starting point value . Adjust the value as necessary.
Note that the distribution volume has to be properly estimated for
the individual patient. The calculation of Kt/V done in the machine
is entirely dependent on the value for the individual patient being
the correct one. For further information; see "Glossary of Diascan
parameters and key terms" in this chapter.
7. When the distribution volume (VOLUME) has been set the second
screen will automatically change and it is possible to set a Kt/V
target value that is to be achieved at treatment end, and an alarm
limit for Kt/V.
Press the lit Arrow button below TARGET; the text will flash. Turn the
Set knob clockwise until a suitable value is shown. The machine uses
the set target value to calculate the time needed to reach the target.
For further information; see " The second screen", in this chapter.
8. If an alarm limit for Kt/V is required, press the lit Arrow button below
LIMIT; the text will flash. Turn the Set knob clockwise until a suitable
alarm limit value is shown. For further information; see "Alarms,
Kt/V alarm limit", in this chapter.
Figure 11:16 Diascan, distribution volume, Kt/V target and alarm limit set
The first Kt/V and clearance measurement check in the sequence will
be performed on an appropriate occasion chosen by the machine. The
occasions chosen are dependent on when the self-calibrations of the
machine are to be performed.
The Kt/V button will light up (steady light) during the period of time when
the measurement checks are being performed.
Result
Note
• Changes in treatment parameters (above all blood flow rate) affect
measured clearance (K) values obtained during treatment and
consequently the calculated Kt/V result. If the Kt/V calculation at
treatment end is based on few clearance results, or only one, check
that these results are relevant for the complete treatment. This is in
order to ensure that the Kt/V value is a relevant one.
Note
Chapter 12
Hygiene and maintenance

General hygiene and maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:2
Glossary of disinfection terms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:3
Disinfection history . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:4
List of disinfection screen symbols . . . . . . . . . . . . . . . . . . . . . . . . . 12:4
Schedule for hygiene and maintenance . . . . . . . . . . . . . . . . . . . . . . . . . 12:6
When the machine is planned not to be in use . . . . . . . . . . . . . . . . 12:7
Characteristics of different disinfection, decalcification and cleaning
agents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:8
Hygiene - Heat disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:9
General - Heat disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:9
Performing Heat disinfection program . . . . . . . . . . . . . . . . . . . . . . . . 12:11
Performing Heat disinfection program with CleanCart . . . . . . . . . . . . 12:12
Performing Heat disinfection program with liquid citric acid . . . . . . . 12:13
Performing integrated Heat disinfection program with WRO 300 H . . 12:14
Automatic start of Heat disinfection program . . . . . . . . . . . . . . . . . . . 12:16
Automatic switch off after Heat disinfection program . . . . . . . . . . . . . 12:17
Integrated Heat disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:17
Hygiene - Chemical disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:18
General - Chemical disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:18
Chemical disinfectants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:19
Performing Chemical disinfection program . . . . . . . . . . . . . . . . . . . . . 12:20
Filling the machine with chemical disinfectant . . . . . . . . . . . . . . . . 12:21
Residual test after Chemical disinfection . . . . . . . . . . . . . . . . . . . . . . . 12:23
Central Chemical disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:24
Performing central Chemical disinfection . . . . . . . . . . . . . . . . . . . . . . 12:24
Hygiene - Rinse/Drain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:25
Performing Rinse/Drain program . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:25
Performing Rinse/Drain program with CleanCart . . . . . . . . . . . . . . . . 12:26
Automatic start of Rinse/Drain program . . . . . . . . . . . . . . . . . . . . . . . 12:28
Automatic switch off after Rinse/Drain program . . . . . . . . . . . . . . . . 12:29
Maintenance - the flow path . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:30
The flow path . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:30
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:30
Decalcification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:30
Ultrafilter; how to change . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:31
Ultrafilter replacement reminder . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:32
Maintenance - the exterior of the machine . . . . . . . . . . . . . . . . . . . . . . . . 12:33
The outside . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:33
Top tray . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:33
Blood pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:33
Blood leak detector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:33
BPM cuff . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12:34
Program version 8.xx AK 200 S Operator’s manual - Hygiene and maintenance 12:1
General hygiene and maintenance
The contents of this chapter concern the hygiene and maintenance of the
AK 200 S that should be carried out by the operator of the machine.
CAUTION
No other maintenance than that mentioned in this chapter shall
be performed by the operator/user of the machine. The casing
must only be opened by a fully trained service technician, refer to
the Service Manual.
Preventive maintenance shall be performed according to instructions

in "General precautions before use" in chapter 1, in this manual.
CAUTION
In order to maintain high microbiological quality of the dialysis fluid,

it is important that the operator/user is attentive to hygiene and the
maintenance of the machine. There are factors and procedures that affect
the hygiene of the flow path and consequently the quality of the prepared
dialysis fluid. The following must be considered:
• the disinfection, decalcification and cleaning must be performed

according to instructions in this chapter
• the frequency of disinfection, decalcification and cleaning of the

machine should be carried out according to recommendations in
this chapter
• the quality of the inlet water entering the machine
• the quality of the concentrates being used
• the inlet water tube, which preferably should be disinfected by using

integrated heat disinfection program
• the arrangement of the drain connection from the machine, either

using the integrated air-gap on the machine or via an arranged air-gap,
to avoid back contamination from the drain system in both cases
Note
• An attention alarm appears when the machine is started if more than
7 days1 have passed since the last complete disinfection. It is still
possible to perform a treatment, and the attention light will switch
off as soon as the priming button is lit (steady light). However, the
attention alarm will appear again the next time the machine is turned
on, if a disinfection program has not been completely carried out.
Note
1 The period of time can be preset
12:2 AK 200 S Operator’s manual - Hygiene and maintenance Program version 8.xx
Glossary of disinfection terms
Disinfection is removal or reduction of bacteria in the fluid path of the
dialysis machine.
Decalcification is removal of calcium and magnesium carbonate

precipitates in the fluid path, originating from the bicarbonate dialysis
fluid.
Cleaning is removal of fats, proteins and organic material, originating

from the patient and located mainly in the fluid path of the machine
downstream the dialyzer.
Disinfection history
When the Heat disinf or Chem disinf button is pressed a list of the most
recently performed disinfection programs (both heat and chemical
disinfection programs) will be displayed on the screen. The last
performed disinfection program is shown at the top of the screen. The 50
most recently performed disinfection programs can be displayed, scroll
up and down by using the Set knob.
The symbols to the left on the screen show type of disinfection program.
See list of disinfection symbols below.
Date and time are shown next.

If the disinfection program was successfully performed, the time for
when the disinfection program was complete, in combination with a
green tick, is shown.
If the disinfection program was not successfully performed, the time
for when the disinfection program was started, in combination with a
red cross, is shown.
List of disinfection screen symbols
indicates Heat disinfection program.
C
indicates Heat disinfection program with CleanCart.
indicates Heat disinfection program with liquid Citric acid.
L
indicates Chemical disinfection program with low concentration
Peracetic acid.
P
indicates Chemical disinfection program with Peracetic acid.
H
indicates Chemical disinfection program with Sodium hypochlorite.
F
indicates Chemical disinfection program with Formaldehyde.
indicates Chemical disinfection program with other chemical

disinfectant.
indicates Central chemical disinfection.
C
indicates Chemical disinfection program with liquid Citric acid.
Schedule for hygiene and maintenance
The schedule below is recommended for use by the operator/user of the
AK 200 S. This recommendation is to keep a high level of performance of
the machine. It is also a guideline for maintaining the hygiene of the fluid
path and the outside of the machine to ensure the safety of the patient.
Frequency Measures Cleaning Decalcification Disinfection

After each 1) Heat disinfection program.
treatment 2) Wipe down the outside
x
of the machine with 70%
ethanol or 60% isopropanol.
At least after Combine the Heat
every third disinfection program with
x x x
treatment CleanCart C or liquid citric
acid.
At least once Heat disinfection program
every seventh in combination with
treatment day CleanCart A or a Chemical
disinfection program with
sodium hypochlorite. This
x x x
should be performed directly
after a Heat disinfection
program in combination with
CleanCart C or liquid citric
acid.
When Heat disinfection program
time after before treatment.
disinfection x
has exceeded
seven days
Once every Change of ultrafilter followed
one to three by a Heat disinfection
months if program. x
UFD is
installed2
2 For more information, see “Ultrafilters; frequency of change” in chapter 1
Any Heat disinfection program can be exchanged to a Heat disinfection
program in combination with CleanCart C or liquid citric acid.
Heat disinfection can be replaced by Chemical disinfection but note that

decalcification with CleanCart C or liquid citric acid has to be performed
at least after every third treatment.
An integrated Heat disinfection program is recommended when possible

since it also includes the inlet water tube.
In order to enable the cleaning agents to remove fats, proteins etc.

efficiently, cleaning (CleanCart A or sodium hypochlorite) should be
carried out after decalcification (CleanCart C or liquid citric acid).
Note
• An attention alarm appears when the machine is started if more than
7 days3 have passed since the last complete disinfection. It is still
possible to perform a treatment, and the attention light will switch
off as soon as the priming button is lit (steady light). However, the
attention alarm will appear again the next time the machine is turned
on, if a disinfection program has not been completely carried out.
Note
When the machine is planned not to be in use

If the machine is planned not to be in use for a period of time exceeding
seven days the microbiological standard of the flow path can be
maintained with one of the following alternatives:
• Perform a Heat disinfection program at least every seventh day and a

Heat disinfection program before treatment.
• Fill the machine with a proper chemical disinfectant in order to

preserve it.
3 The period of time can be preset
Characteristics of different disinfection, decalcification
and cleaning agents
The table below summarizes the characteristics of some generic
substances used for internal disinfection, decalcification and cleaning of
the AK 200 S. For more specific information about a certain commercial
product, see manufacturer’s information.
Disinfection, decalcification and cleaning
Efficiency on inorganic Efficiency on Efficiency of

precipitates organic precipitates disinfection
fats, proteins
Calcium Iron oxide
CleanCart-C and heat High Low Medium High
CleanCart-A and heat None None High High
Peracetic acid 0.01 to 0.15% Low4 None None High

Citric acid liquid 2% and High Low Medium High
heat
Sodium hypochlorite 0.5% None None High High
Formaldehyde 4% None None None High
Glutardialdehyde 2% None None None High
Decalcification and cleaning could also be performed at a lower temperature
Acetic acid 2% High None None None

Oxalic acid 2%5 Low High None None
CleanCart-C High Low None None
CleanCart-A None None Low None
4 The manufacturers of disinfectants based on peracetic acid claim that these agents can
also be used for decalcification. However, experience has shown that peracetic acid is
not reliable alone, use CleanCart-C, citric acid or acetic acid regularly.
5 Oxalic acid is recommended only when having problems with iron oxide precipitates
(reddish-brown). Oxalic acid increases the wear of the machine.
Hygiene - Heat disinfection
General - Heat disinfection

During the Heat disinfection program (HEAT) the inlet water is heated
up and flushed through the fluid monitor. The program begins with
a rinse in order to rinse out possible residues from concentrates used
in the preceding treatment. After this, the program consists of three
consecutive phases; fill-up phase, circulation phase and drain phase. The
actual disinfection takes place in the circulation phase. The circulation
phase consists of a number of cycles where each cycle is a sequence where
heated water is passed through all parts of the fluid path. The standard
heat disinfection program consists of 15 such cycles.
The AK 200 S fluid path is constructed in a way that prevents

possible contaminants in the post-dialyzer fluid path from reaching the
patient. The construction principle is called single pass, which means no
recirculation in the fluid path, and a separation between the pre-dialyzer
circuit and the post-dialyzer circuit. This is to ensure that no fluid from
the downstream (post) dialyzer circuit comes into contact with the
pre-dialyzer circuit. The construction principle is an effective obstacle
to transmission of blood-borne viruses like Hepatitis B, from the fluid
path to the patient, when a blood leak in the dialyzer has occurred. In
addition the standard heat disinfection program has the capacity to make
viruses inactive.
The combination of the standard heat disinfection program process (15

cycles) and the safe hygienic construction of the fluid path (single pass)
described above provides high safety levels for the patient.
The standard heat disinfection program is validated by using

microbiological challenge tests according to NFS 90-304. The standard
heat disinfection program fulfils the requirements in this standard.
The heat disinfection program can be extended, and has been evaluated
for 25 cycles. 25 cycles may be used in case of substantial contamination
of the fluid path. This program provides different positions of the fluid
path with at least 30% more heat. As a consequence, the duration of this
heat disinfection program will be extended by approximately 10 minutes,
compared to the standard program.
It is possible to run a Heat disinfection program in combination with

CleanCart:
• Decalcification program with CleanCart-C
• Cleaning program with CleanCart-A
If Heat disinfection program with CleanCart is chosen, the contents of

the CleanCart are dissolved and the solution is heated up and flushed
through the fluid monitor during the heat disinfection program as
described above. A rinse phase has been added at the end of the program,
which leads to longer time for the program to be complete.
The CleanCart-C can be replaced by liquid citric acid in order to perform

a decalcification program; Heat disinfection program with liquid citric
acid. The program is performed in a similar way as Heat disinfection
program with CleanCart.
Note
• In order to enable the cleaning agents to remove fats, proteins etc.
efficiently, cleaning should be carried out after decalcification.
Note
For further details; see “Data and specifications/Disinfection and

Cleaning”.
Handling instructions of above mentioned heat disinfection programs are

described further on in this chapter.
Performing Heat disinfection program
Note
• The Heat disinfection program can be interrupted at any time by
pressing the Rinse/Drain button for 3 seconds. The machine will then
interrupt the procedure and finish off with a rinse and drain sequence.
Note
Before starting Heat disinfection program

• Check that the dialysis fluid tubes are connected to the safety
couplings
Procedure
1. Press the Heat disinf button briefly and check that HEAT is flashing on
Figure 12:1 Heat disinfection
The flashing text indicates that the Heat disinfection program, which is
the default procedure, has been selected. If HEAT is not flashing, press
the corresponding Arrow button below HEAT, the text will flash.
2. Confirm the choice by pressing the Heat disinf button for 3 seconds
(the button lights up) and the Heat disinfection program starts.
3. If an automatic switch off is required, press the ON/OFF button for

3 seconds.
4. When the program is complete, rinse and drain sequence included,

the Rinse/Drain button starts to flash.
5. Switch off the machine by pressing the ON/OFF button for 3 seconds.
If a new treatment is to be started, press the flashing Rinse/Drain button to

start a new function check instead of switching off the machine.
Performing Heat disinfection program with CleanCart

Note
• The Heat disinfection program with CleanCart can be interrupted at
any time by pressing the Rinse/Drain button for 3 seconds. The
machine will then interrupt the procedure and finish off with a rinse
and drain sequence.
Note
Before starting Heat disinfection program with CleanCart

couplings
Procedure
1. Press the Heat disinf button briefly and select CleanCart by using the
corresponding Arrow button below CleanCart on the information
display. The text will flash indicating that the Heat disinfection
program with CleanCart has been selected.
(the button lights up).
3. When the attention alarm
CleanCart NOT ATTACHED TO HOLDER

Attach or check Clean Cart
appears, open the latches of the BiCart holder and place the
CleanCart cartridge into the holder. Both pick-up tubes must remain
in the disinfection ports of the machine.
3.a. If the attention alarm
EMPTY AND REMOVE CleanCart

Close holder
appears, open the upper latch. The CleanCart cartridge will now
be emptied. When the CleanCart is empty, remove it and close
the latches.
3.b. Leave the cartridge in the holder during the entire program , it
will automatically be emptied.
4. The Heat disinfection program with CleanCart is now performed.
5. If an automatic switch off is required, press the ON/OFF button for 3
seconds. If preset, the CleanCart cartridge can be left in the holder
until next function check is started.
6. When the program is complete and the machine has been drained,

Performing Heat disinfection program with liquid citric

acid
Note
• The Heat disinfection program with liquid citric acid can be interrupted
at any time by pressing the Rinse/Drain button for 3 seconds. The
machine will then interrupt the procedure and finish off with a rinse
and drain sequence.
Note
Before starting Heat disinfection program with liquid citric acid

couplings
Procedure
1. Press the Heat disinf button briefly and select CITRIC by using the
corresponding Arrow button below CITRIC on the information
display. The text will flash indicating that the Heat disinfection
program with liquid citric acid has been selected.
3. Place the B pick-up tube marked blue-white into the container with
citric acid solution. (The A pick-up tube marked red must remain in
the disinfection port of the machine).
4. When the machine is filled with citric acid solution an attention

alarm appears:
CHEM DIS FILLUP PHASE COMPLETED

Place pick up tube in machine
Put the B pick-up tube back into the disinfection port of machine.
5. The Heat disinfection program with liquid citric acid is now

performed.
3 seconds.

Performing integrated Heat disinfection program with

WRO 300 H
By an authorized technician, the AK 200 S can be preset to perform
integrated Heat disinfection program supported by WRO 300 H. This
program is recommended when possible since it includes heating of the
inlet water tube.
The program starts with a Heat disinfection program of the AK 200 S.

When the circulation phase (see "General - Heat disinfection" in this
chapter) has finished a Low Flow Heat phase automatically starts. In this
phase, the machine will receive hot water from the WRO 300 H, at a low
flow rate, for 15 minutes. When this phase is complete, the machine
finishes the program off as usual, with a drain phase.
Note
• The integrated Heat disinfection program with WRO 300 H can be
interrupted at any time by pressing the Rinse/Drain button for 3
seconds. The machine will then interrupt the procedure and when
the WRO 300 H has cooled down, finish off with a rinse and drain
sequence.
Note
Before starting integrated Heat disinfection program with WRO

300 H
couplings
• Make sure that the WRO 300 H is switched on.
Procedure
1. Press the Heat disinf button briefly and select HEAT+ WRO 300H by
using the corresponding Arrow button below HEAT+ WRO 300H
on the information display. The text will flash indicating that the
integrated Heat disinfection program with WRO 300 H has been
selected.
(the button lights up). The integrated Heat disinfection program with
WRO 300 H will now be performed. For information about the
program, see in the introductory part in these instructions.

3 seconds.
4. When the integrated Heat disinfection program with WRO 300 H is

complete, rinse and drain sequence included, the Rinse/Drain button
starts to flash.

Automatic start of Heat disinfection program
The machine is equipped with an automatic start function for the Heat
disinfection program. Whenever this is activated, and the machine has
been turned off, the Heat disinfection program will be started at the
programmed time (see below).
Before automatic start of Heat disinfection program

couplings
Procedure
1. Press the Auto Heat button briefly.
2. Set the desired ready day (RDY DAY) and ready time (RDY TME) by
using corresponding Arrow buttons and the Set knob.
3. Activate the function by pressing the Auto Heat button for 3 seconds
Figure 12:2 Auto Heat
If a weekly program is to be selected:
1. Press the Auto Heat button briefly.
The automatic function can be switched off for the selected day by
setting the ready time (RDY TME) to OFF (i.e. setting the time between
23:59 h and 0:00 h).
3. Select the next day (RDY DAY) by using the corresponding

Arrow button and the Set knob.
4. Select the ready time (RDY TME) or the OFF function (see above)
for that day by using the corresponding Arrow button and the Set knob.
Proceed according to the above until a complete weekly program
has been set.
5. Activate the function by pressing the Auto Heat button for 3 seconds
Note
• The lit Auto Heat button must be pressed for 3 seconds (the button is
extinguished) for the function to be deactivated.
Note
In combination with CleanCart

If a Heat disinfection program with CleanCart is desired, place a
CleanCart cartridge into the BiCart holder before the automatic start of
the Heat disinfection program is set to be started.
Automatic switch off after Heat disinfection program

The machine can be preset to switch itself off after a complete Heat
disinfection program, i.e. when the Rinse/Drain button is flashing, by a
qualified technician in the clinic.
It can also be switched off during the Heat disinfection program by

manually pressing the ON/OFF button while the program is running.
This will make all of the operator panel lights go out, except for the
Heat disinf button and the time display. When the final drain starts the
Rinse/Drain button lights up while the Heat disinf button is extinguished.
When the program is complete the Rinse/Drain button flashes three times,
the time display lights go out, the inlet valve closes and the machine is
automatically switched off.
Integrated Heat disinfection

The AK 200 S can be programmed to perform integrated Heat
disinfection.
In this mode, the machine receives hot water from the central water supply
system when performing Heat disinfection. The Heat disinfection can
be started manually or preferably be programmed to start automatically,
during heating of the central water supply system.
The advantage with integrated Heat disinfection is that the tube between
the central water supply system (inlet water tube) and the machine is
also disinfected.
Hygiene - Chemical disinfection
General - Chemical disinfection

CAUTION
Disinfectants may be toxic. The user must therefore take note of
necessary precautions before use. The manufacturer’s instructions
and recommendations have to be followed. Local regulations
regarding the utilization of the different chemicals must be followed.

CAUTION
During Chemical disinfection program the machine is filled with

disinfectant. The disinfectant could be concentrated or already diluted.
If it is concentrated it is mixed with water to the correct concentration
in the machine. The solution is then filled in all parts of the fluid path.
After the Dwell time (the time when the fluid path is filled with correct
concentration of the disinfectant) the machine is rinsed and drained. If the
machine is not to be used for a long period of time it is possible to turn it
off during the dwell time and then it stays filled until it is started again.
For further details; see “Data and specifications/Disinfection and

Cleaning”.
Chemical disinfectants
Chemical disinfectants may be harmful to the materials used in the fluid
path of dialysis machines. Disinfectants may also contain additives that
cause foaming or are difficult to rinse out. The disinfectants listed below
are examples of chemicals recommended for use in the AK 200 S, i.e.
they are compatible with the materials in the machine, provided that they
are used in accordance with the recommendations in chapter “Technical
data and specifications/Disinfection and Cleaning”. It is essential that
the chemical disinfection program is adapted to the disinfectant used
regarding dilution and dwell time. The machine has to be properly preset
by a qualified technician.
CAUTION
Local regulations have to be followed regarding approved levels
of disinfectant residues.

CAUTION
Solutions based on peracetic acid:
Active ingredients: Peracetic acid and hydrogen peroxide.

Trade names: Dialox, Renalin, Actril, Acetoper, Puristeril
340, Peresal
Test for residues: Iodine starch test strips (e.g. Merckoquant
10011). Follow the manufacturers
recommendations.
Sodium hypochlorite:
Active ingredient: Sodium hypochlorite

Test for residues: Chlorine test kit (e.g. Hach or Merck)
Other disinfectants based on sodium hypochlorite:
Active ingredient: Sodium hypochlorite

Trade names: Maranon H and Amuchina
Test for residues: Follow the manufacturers instructions
Formaldehyde:
Active ingredient: Formaldehyde

Trade name: Rectapur
Test for residues: Formalert or Aquamerck 8028. Note that
the ultrafilter used in UFD kit must be
changed prior to the following treatment.
Alternatively perform additional
rinse/drain procedures according to
section “Residual test after Chemical
disinfection” in this chapter.
For further information about the disinfectants, such as dwell times,

concentrations, consumption and mixing instructions, see “Technical data
and specifications/Disinfection and Cleaning”.
Performing Chemical disinfection program
Before starting Chemical disinfection program

couplings
Procedure
1. Press the Chem disinf button briefly and select the desired
program/chemical by using the corresponding Arrow button below
the desired alternative on the information display. The text will flash
indicating that the desired alternative has been selected.
Figure 12:3 Chemical disinfection
PER-LOW is the default program which will be performed if nothing else

is selected. The text will flash indicating that PER-LOW has been selected.
2. Confirm the choice by pressing the Chem disinf button for 3 seconds
3. Place the B pick-up tube marked blue-white into a container with

the appropriate disinfectant. (The A pick-up tube marked red must
remain in the disinfection port of the machine).
4. When the machine is filled with disinfectant an attention alarm

appears:

Put the B pick-up tube back into the disinfection port of machine.
5. The Chemical disinfection program is now performed. The

Chem disinf button will remain lit until the final rinse starts.
6. Do not switch the machine off until the Rinse/Drain procedure has
started i.e. the Rinse/Drain button lights up. (See “Filling the machine
with chemical disinfectant” below.)
9. If FORMAL program has been performed, the ultrafilter used in UFD

kit must be changed prior to the following treatment. Alternatively
perform additional rinse/drain procedures according to section
“Residual test after Chemical disinfection” in this chapter.

The machine can be preset to switch itself off after a complete Chemical
CAUTION
CAUTION
Filling the machine with chemical disinfectant

There may be a need to fill the machine with a chemical disinfectant
during storage or when the AK 200 S is planned to be left unused for
a long period of time. The chemical disinfectant should preferably be
peracetic acid.
In order to perform a filling of the machine with chemical disinfectant

follow the instructions below “Performing Chemical disinfection
program” in this chapter - points 1, 2, 3 and 4. Continue as follows:
5. Press the ON/OFF button as soon as the B pick-up tube has been put
back into the disinfection port of machine. The machine will continue
to run the program for some minutes after the ON/OFF button has
been pressed. This is to fill up all the tubes and to even out the
concentration of the disinfectant. Now the machine is filled with
disinfectant.
6. When the machine is to be used again and the ON/OFF button

is pressed, the machine will start up with a Rinse/Drain program
as soon as it is switched on. The Chem disinf button will be lit at this
moment as well as the Rinse/Drain button. The remaining time will
be shown on the time display. The Chem disinf button will remain
lit until the final rinse starts and during this sequence only the
Rinse/Drain button will be lit.
9. If FORMAL program has been performed, the ultrafilter used in UFD

kit must be changed prior to the following treatment. Alternatively
perform additional rinse/drain procedures according to section
“Residual test after Chemical disinfection” in this chapter.

The machine can be preset to switch itself off after a complete Chemical
CAUTION
CAUTION
Residual test after Chemical disinfection
Before connecting a patient a residual test must be done on the prepared
dialysis fluid. This is to make sure that the patient will not be exposed to
chemical residuals after a chemical disinfection program.
The residual concentration in the dialysis fluid must be below levels

specified by the clinic or by national standards. It is essential to use an
appropriate test method, either with proven sensitivity for the chemical or
recommended by the manufacturer of the chemical disinfectant.
1. Switch the machine on and let it pass function check (Fch) with the
proper concentrates attached.
2. When the green fluid path lights up, press the flashing
Fluid bypass button in order to let fresh dialysis fluid flow through the
dialysis fluid tubes.
3. Take the residual test sample from the flowing fluid on the dialysis
fluid outlet tube (to dialyzer).
If the tests shows disinfectant residues:
• DO NOT use connected BiCart and SelectCart.
• Press the Rinse/Drain button for 3 seconds (the button lights up) and
start a new rinse/drain procedure. When this is finished, repeat the
handling procedure described above.
If the machine still shows disinfectant residues, contact service technician.
CAUTION
CAUTION
Central Chemical disinfection
The AK 200 S can be programmed to perform Central Chemical
disinfection . In this mode, the machine receives disinfection solution
through the central water supply system. The Central disinfection
program in AK 200 S performs a drain and then a fill with disinfection
solution. During the dwell time the pumps are turned off.
It is advisable to turn the AK 200 S off if it is not supposed to be

disinfected; this is to make sure that no disinfection solution will enter the
machine when not desired.
Performing central Chemical disinfection
Before starting central Chemical disinfection program

couplings
Procedure
1. Press the Chem disinf button briefly.
2. Select CENTRAL DISINF. by using the corresponding

Arrow button below CENTRAL DISINF. on the information
display. The text will flash indicating that Central Chemical
disinfection program has been selected.
3. Confirm the choice by pressing the Chem disinf button for 3 seconds
4. When the preset dwell time has passed, an attention is given to

indicate that the Rinse/Drain sequence can be started.
When no more chemicals are left in the central water supply system:
5. Start the Rinse/Drain program by pressing the Rinse/Drain button for

3 seconds (the button lights up).
6. When the Rinse/Drain program is complete and the machine has

been drained, the Rinse/Drain button starts to flash.
CAUTION
CAUTION
Hygiene - Rinse/Drain
Performing Rinse/Drain program

Note
• The Rinse/Drain program can be interrupted at any time by pressing
the Rinse/Drain button for 3 seconds. The machine will then interrupt
the procedure and finish off with drain sequence.
Note
Before starting Rinse/Drain program

couplings
Procedure
1. Press the Rinse/Drain button briefly and check that RINSE is flashing
on the information display.
Figure 12:4 Rinse/Drain
The flashing text indicates that the Rinse/Drain program, which is the
default procedure, has been selected. If RINSE is not flashing, press the
corresponding Arrow button below RINSE, the text will flash.
2. Confirm the choice by pressing the Rinse/Drain button for 3 seconds

(the button lights up) and the Rinse/Drain program starts. If the
button is pressed a second time for 3 seconds an immediate drain
starts.

3 seconds.
4. When the program is complete, the Rinse/Drain button starts to flash.

Performing Rinse/Drain program with CleanCart

Note
• The Rinse/Drain program with CleanCart can be interrupted at any
time by pressing the Rinse/Drain button for 3 seconds. The machine
will then interrupt the procedure and finish off with a rinse and drain
sequence.
Note
Before starting Rinse/Drain program with CleanCart

couplings
Procedure
1. Press the Rinse/Drain button briefly and select CleanCart by using
the corresponding Arrow button below CleanCart on the information
display. The text will flash indicating that the Rinse/Drain program
with CleanCart has been selected.
2. Confirm the choice by pressing the Rinse/Drain button for 3 seconds

3. When the attention alarm

Attach or check Clean Cart
appears, open the latches of the BiCart holder and place the
CleanCart cartridge into the holder. Both pick-up tubes must remain
in the disinfection ports of the machine.
3.a. If the attention alarm

Close holder
appears, open the upper latch. The CleanCart cartridge will now
be emptied. When the CleanCart is empty, remove it and close
the latches.
3.b. Leave the cartridge in the holder during the entire program , it
will automatically be emptied.
4. The Rinse/Drain program with CleanCart is now performed.
5. If an automatic switch off is required, press the ON/OFF button for 3
seconds. If preset, the CleanCart cartridge can be left in the holder
until next function check is started.

Automatic start of Rinse/Drain program
The machine is equipped with an automatic start function for the
Rinse/Drain program. Whenever this is activated, and the machine
has been turned off, the Rinse/Drain program will be started at the
programmed time (see below).
Before automatic start of Rinse/Drain program

couplings
Procedure
1. Press the Auto Rinse button briefly.
3. Activate the function by pressing the Auto Rinse button for 3 seconds
Figure 12:5 Auto Rinse
If a weekly program is to be selected:
1. Press the Auto Rinse button briefly.
The automatic function can be switched off for the selected day by
setting the ready time (RDY TME) to OFF (i.e. setting the time between
23:59 h and 0:00 h).
3. Select the next day (RDY DAY) by using the corresponding

Arrow button and the Set knob.
4. Select the ready time (RDY TME) or the OFF function (see above)
for that day by using the corresponding Arrow button and the Set knob.
Proceed according to the above until a complete weekly program
has been set.
5. Activate the function by pressing Auto Rinse button for 3 seconds (the
button lights up).
Note
• The lit Auto Rinse button must be pressed for 3 seconds (the button
is extinguished) for the function to be deactivated.
Note
In combination with CleanCart

If a Rinse/Drain program with CleanCart is desired, place a CleanCart
cartridge into the BiCart holder before the automatic start of the
Rinse/Drain program is set to be started.
Automatic switch off after Rinse/Drain program

The machine can be preset to switch itself off after a complete
Rinse/Drain program, i.e. when the Rinse/Drain button is flashing, by a
It can also be switched off during the Rinse/Drain program by manually

pressing the ON/OFF button while the program is running. This will make
all of the operator panel lights go out, except for the Rinse/Drain button
and the time display. When the program is complete the Rinse/Drain button
flashes three times, the time display lights go out, the inlet valve closes
and the machine is automatically switched off.
Maintenance - the flow path
The flow path

The maintenance of the flow path with aspect to cleaning and
decalcification is important in order to maintain the specified performance
of the machine.
Cleaning
Fats, proteins and organic material originating from the patient may
deposit down stream the dialyzer. The requirements for cleaning vary
depending on the use of convective therapies (Low volume HDF) and the
permeability properties of the used dialyzer membranes. The number of
treatments and the setting of parameters will also influence the amount of
deposits downstream the dialyzer. A general guideline for the frequency
of cleaning with CleanCart-C and sodium hypochlorite (alternatively
CleanCart-A) is described in the introductory part of this chapter. An
increased cleaning may be necessary but, depending on the conditions
described above, also a lower frequency may be sufficient to maintain
the system.
Decalcification
Calcium carbonate may deposit in the flow path. The requirements
for decalcification vary depending on elements as water quality, type
of concentrate and Bicarbonate settings. A general guideline for the
frequency of decalcification with CleanCart-C or liquid citric acid
is described in the introductory part of this chapter. An increased
decalcification may be necessary but, depending on the conditions
described above, also a lower frequency may be sufficient to maintain
the system.
Note
• Incorrect cleaning of the UF cell may be a contributing factor
for increased inaccuracy of the UF system. If any deviations in
UF accuracy should occur, it is recommended to use sodium
hypochlorite weekly.
• In order to enable the cleaning agents to remove fats, proteins etc.

efficiently, cleaning should be carried out after decalcification.
Note
Ultrafilter; how to change
Note
• Make sure that the ultrafilter is changed in an aseptic way.
Note
1. Release the lower part of the ultrafilter holder by pulling the handle
and pressing the latch downwards.
2. Remove the ultrafilter by pulling it gently downwards.
3. Insert the new ultrafilter into the holder and push it gently upwards.
4. Close the holder by pushing the lower latch into position.
5. Label the ultrafilter with date for change.
6. Perform a Heat disinfection program before the AK 200 S is used

for treatment after the ultrafilter has been changed.
Ultrafilter replacement reminder
By preset, an attention alarm can be generated when it is time for the
ultrafilter to be changed. The reminder can appear when a preset number
of days have passed or when a preset number of heat disinfection
programs have been performed (or a combination of both) since the last
change of ultrafilter.
When the preset is active, and it is time for the ultrafilter to be changed,
this attention appears when the machine has been started:
NEW ULTRA FILTERS REQUIRED

Replace ULTRA filters
The attention alarm will disappear as soon as priming is activated.
When the ultrafilter has been changed, press the Heat disinf or the
Chem disinf button twice and this screen will appear on the information
display:
Figure 12:6 Ultrafilter replacement
Confirm the ultrafilter change by pressing the lit Arrow button for three
seconds.
The text on the screen will change to:
ULTRA FILTER REPLACEMENT
New filter confirmed!
and the counting of number of days and/or heat disinfection programs
will be set to zero.
The calendar symbol on the screen indicates the date of the latest
ultrafilter change.
The thermometer symbol indicates number of heat disinfection programs
performed and the hourglass indicates number of days since the latest
change of ultrafilter.
Maintenance - the exterior of the machine
The outside
Wipe the outside of the machine with a cloth moistened with ethanol
(70%) or isopropanol (60%) in order to clean and disinfect it.
Note
• Do not use tenside-containing or iodine-based disinfectants. These
solutions may crack or discolour most polymers.
Note
Top tray
The top tray may be cleaned and disinfected with ethanol (70%) or
isopropanol (60%).
CAUTION
In order to protect the internal parts of the AK 200 S against
spillage, the top tray must always be placed on top of the machine,
except during technical service.
CAUTION
Blood pump
To remove the blood pump rotor; pull out the handle. Turn until the
blood pump rotor loosens from the pump shaft.
The blood pump rotor can be cleaned and disinfected in ethanol (70%)
or isopropanol (60%).
To attach the blood pump rotor; place it on the pump shaft. Move your
fingers from the handle and place them on the rotor. Turn the rotor
slowly and push slightly until it reaches the bottom position. Continue
turning until the blood pump handle clicks in.
Blood leak detector

The blood leak detector shall only be cleaned when a suspected false
blood leak alarm has occurred and not as a preventive action, as the
risk of contaminating the blood leak detector is large when opening it.
Unscrew the blood leak detector cover and clean the lenses with a soft
non-fluffy cloth, moistened with disinfectant solution.
Note
• Make sure that the sealing ring on the inside of the cover is securely
in place when replacing the cover.
Note
BPM cuff
The instructions below concerns only the standard cuffs; No. 1 to No. 4.
Use a damp cloth with 70% ethyl alcohol or 30 to 50% isopropyl alcohol
for cleaning the surface of the cuff. Never put any solutions inside the
cuff. If this occurs, dry the inside of cuff before use.
The cloth covering of the cuff is removable and washable.
The following procedure shown below is the procedure for taking the
rubber bladder out of the cloth bag.
In the cloth bag are holes for the rubber bladder and the rubber hose.
The large hole is used to put the rubber bladder through and the small
hole is used to put the rubber hose through. Figure A.
Put the rubber hose inside and pull out the inside cloth to make the hole
larger. Figure B and C.
Take the rubber bag out of the larger hole. Figure D.
Figure 12:7 BPM cuff, removal procedure of rubber bladder from cloth bag
1. Small hole
2. Large hole
Reverse the order when putting the rubber bladder in the cloth bag.
When the cloth bag of the cuff is removed, pay attention to the hole
through which the rubber hose of the rubber bladder goes. Unless the
hole is used, the rubber bag gets out of the cloth bag, leading to blow out.
Chapter 13
Technical data and specifications

Performance and specification - Control System . . . . . . . . . . . . . . . . . . . . 13:2
Blood Flow Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:2
Air Detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:3
Blood Volume Sensor (BVS) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:3
Blood Pressure Monitor (BPM) . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:3
Ultrafiltration control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:5
Profiling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:5
Diascan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:6
Disinfection and Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:6
Water supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:9
Drain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:10
Power supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:10
Connection of external equipment . . . . . . . . . . . . . . . . . . . . . . . . . 13:10
Battery Back-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:12
Performance and specification - Supervisory system . . . . . . . . . . . . . . . . . 13:13
Blood Pressure Supervision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:13
Air Detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:14
Ultrafiltration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:15
Blood leak detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:15
Physical data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:16
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:16
Materials in contact with water, concentrates and dialysis fluid . . . . . . . . . 13:17
Polymers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:17
Metals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:17
Others . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:17
Environmental data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:18
Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:18
Transportation and storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:18
Electromagnetic environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:18
Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13:22
Program version 8.xx AK 200 S Operator’s manual - Technical data and specifications 13:1
Performance and specification - Control
System
Note
• When accuracy ranges are written as e.g. “(±1 ml/min or ±1%)” the
• For the qualified technician the AK 200 S Service Manual is available.

The Service Manual provides all the necessary information for the
safe and required maintenance of the machine.
Note
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. It is possible to
preset the machine so the blood flow values are based only on the blood
pump rotations. 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.
Double Needle
Blood Flows in HD, single 20 to 500 ml/min (±10 ml/min or ±15%)

pump:
Blood Flows in Low volume 20 to 500 ml/min (±10 ml/min or ±15%)
HDF:
Accumulated blood volume: 0 to 327 litres (±0.6 l * treatment time (h)
or ±15%)
Single Needle Single Pump
Arterial flow: 20 to 500 ml/min (±10 ml/min or ±18%)

Time control: 2 to 20 sec (±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 600 mmHg (±50 mmHg), venous
pressure control
Accumulated blood volume: 0 to 327 litres (±0.6 l * treatment time (h)
or ±18%)
Single Needle Double Pump (HD only)
Double pump-A 20 to 800 ml/min

Double pump-V 20 to 800 ml/min
Mean Flow-SN/DP 10 to 400 ml/min (±10 ml or ±15%)
Accumulated blood volume 0 to 99.9 litres (±0.6 l * treatment time (h)
or ±15%)
Stroke Volume-SN/DP 20 to 60 ml/stroke (±15%) at a cycle time
< 20 s
13:2 AK 200 S Operator’s manual - Technical data and specifications Program version 8.xx
Air Detection
Sensitivity Bubbles larger than 1 µl 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 22 mm
(diameter)
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 0 to 4.00 h.min (±1 min) (20 min)
(Default)
Syringe size, can be preset 6 to 30 ml (30 ml)
(Default)
Maximum counter pressure +650 mmHg
The accuracy is based on tests with 20 ml and 30 ml syringes
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
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 range1 60 - 250 mmHg

Low alarm limit 60 - 250 mmHg (100 mmHg)
High alarm limit 60 - 250 mmHg (150 mmHg)
Diastolic pressure range1 40 - 200 mmHg
Mean pressure range1 45 - 235 mmHg
Pulse rate range 40 - 200 bpm (±2 bpm or ±2 % of reading)
Low alarm limit 40 - 180 bpm (40 bpm)
High alarm limit 40 - 180 bpm (150 bpm)
1 Meets ANSI/AAMI SP-10 (1992). Mean error ±5 mmHg. Standard

deviation 8 mmHg
Dialysis fluid preparation
Temperature
Dialysis Fluid Temperature 30-39 °C (+0,5/-1,5 °C) (+0,5/-2,0 °C)

with UFD-kit at fluid flow < 500 ml/min.
Accuracy is valid only if dialysis fluid
temperature is greater or equal to ambient
temperature.
Temperature low alarm, can 28 to 40 °C (35°)
be preset (Default)
Temperature high alarm, can 28 to 40 °C (39°)
be preset (Default)
Fluid flow
Dialysis Fluid Flow Rate 300 to 700 ml/min (±10 ml/min)
Conductivity
Conductivity measuring 0.1 - 20 mS/cm (±0.1 mS/cm)

Alarm limits in Acetate ±5 % of set value
mode
Alarm limit in Bicarbonate ±5% of set value for A-step conductivity
mode, A-step
Alarm Limit in Bicarbonate ±5% of set value for B-step conductivity
mode, B-step
Alarm limits are extended to 10% for maximum 2 minutes of 10 minutes
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)
Concentrates
Max. pressure for concen- +50 kPa

trates
pH supervision
pH measurement of Dialysis 1 to 9.9 pH units (±0,2 pH units)

Fluid
pH low alarm, can be preset 1 to 15 pH units (6 Acetate mode, 6.5 Bicarb
(Default) mode)
pH high alarm, can be preset 1 to 15 pH units (8 Acetate mode, 7.8 Bicarb
(Default) mode)
Degassing
Degassing pressure in -700 to -500 mmHg (±30 mmHg) (-630

Acetate mode, can be preset mmHg) Minimum 75 mmHg absolute
(Default) pressure
Degassing pressure in -700 to -500 mmHg (±30 mmHg) (-580
Bicarbonate mode, can be mmHg) Minimum 75 mmHg absolute
preset (Default) pressure
Dialysis fluid preparation (BiCart Select mode only)

Fluid flow
SelectBag Proportioning 1:400 (±3%)

Ratio SelectBag Proportioning Ratio is defined
as the quotient SelectBag flow/dialysis
fluid flow
Ultrafiltration 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)
Substitution fluid (Low volume HDF)

Substitution fluid flow rate 1.0 to 2.0 l/h (±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
HCO3-, Bicarbonate mode 20 to 40 mmol/l
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
Diascan
Accuracy is valid in HD double needle and on-line HDF postdilution, 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 0 to 100 l (±10%)
cleared of urea, Kt
Dialysis dose, Kt/V 0 to 3 (±10%)
Plasma sodium, Na+ 130 to 160 mmol/l
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 S 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.
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))
Heat disinfection Program with CleanCart
Decalcification CleanCart-C
Cleaning CleanCart-A
Temperature 93 °C
Fill up and mixing phase 12 minutes (13 minutes with UFD-kit,
(optional))
Rinse/Drain phase 5 minutes (15 minutes with UFD-kit,
(optional))
(optional))
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))
Rinse/Drain phase 13 minutes
Total time 43 minutes
Heat disinfection Program with WRO 300 H
Temperature 93 °C
Fill up phase 10 minutes (13 minutes with UFD-kit,
(optional))
Low flow heat phase 20 minutes
Drain phase 4 minutes
(optional))
Peracetic Acid Program
Concentration of disinfec- 3.5 % peracetic acid

tant
Concentration in machine 0.1 %; i.e. diluted 1 + 34
(Approx. 75 ml with UFD-kit, (optional))
Dwell time 10 minutes
Total time 48 minutes including 10 min dwell time
(73 minutes including 10 min dwell time
with UFD-kit, (optional))
Low concentration Peracetic Acid Program
Concentration of disinfec- 0.35 % peracetic acid

tant (0.35 % peracetic acid with UFD-kit,
(optional))
Concentration in machine 0.01 % ; i.e. diluted 1 + 34
(0.01 % ; i.e. diluted 1 + 34 with UFD-kit,
(optional))
Consumption approx. 65 ml
(approx. 75 ml with UFD-kit, (optional))
Hypochlorite Program
Concentration of disinfec- 0.5% available chlorine (approximately 70%

tant of sodium hypochlorite concentration)
Concentration in machine 0.5% ; i.e. not diluted
(Approx. 2500 ml with UFD-kit,
(optional))
Dwell time 10 minutes, Maximum 20 min
Formaldehyde Program
Concentration of disinfec- 4% formaldehyde

tant
Concentration in machine 4% ; i.e. not diluted
(optional))
Central Disinfection Program
Concentration of disinfec- 0.1% peracetic acid or 0.5% available

tant chlorine
Concentration in machine Not diluted
(optional))
Dwell time Must be preset, maximum 20 min. for
hypochlorite
Total time 35 minutes (dwell time not included)
(66 minutes (dwell time not included) with
UFD-kit, (optional))
Other programs, total time
Rinse/Drain with CleanCart 31 min (32 min with UFD-kit, (optional))

Rinse/Drain 12 min (13 min with UFD-kit, (optional))
Drain 4 min
External Cleaning 70% ethanol or 60% Isopropanol
Water supply
Water Supply Flow Rate
Treatment 300 to 750 ml/min
Disinfection 0 to 1150 ml/min
Inlet Water Pressure
to regulator 120 to 800 kPa
to machine 85 to 120 kPa
Inlet Water Temperature
Treatment +5 to +30 °C
Disinfection +5 to +90 °C
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.
Inlet tube length Maximum 5 m or the specially designed
spiral PEX tubing
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.
Power supply
Mains Voltage 115; 230 V AC (±10%)
Frequency 50 to 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: Earthed plug, 250 V AC / 10 -16 A,
approved or Hospital grade, earthed plug,
125 V AC / 15 A, approved.
Earth Leakage Current max 500 µA, typical <100 µA (115 V), max
500 µA, typical <145 µA (230 V)
Patient Leakage Current max 100 µA, typical <10 µA (115 V), max
100 µA, typical <10 µA (230 V)
Fuses 2 x T 12 A
All leakage currents are specified without external equipment connected
to the machine.
Connection of external equipment

External equipment intended for connection to signal input, signal
output or other connectors, shall comply with relevant IEC standard
(e.g. IEC 60950 for IT equipment and the IEC 60601 series for medical
electrical equipment). In addition, all such combinations - systems -
shall comply with the standard IEC 60601-1-1, Safety requirements for
medical electrical systems. Equipment not complying to IEC 60601 shall be
kept outside the patient environment, as defined in the standard. (The
normal distance can be mentioned i.e. at least 1.5 m from the patient or
the patient support.) Any person who connects external equipment to
signal input, signal output or other connectors has formed a system and
is therefore responsible for the system to comply with the requirements
of IEC 60601-1-1. If in doubt, contact qualified technician or your local
representative. 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.
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.
RS-232
Max input voltage: ± 15 V DC

High level min output + 5 V DC
voltage:
Low level max output - 5 V DC
voltage:
Max output current: ± 5 mA
RS-422
Max input voltage: ± 7 V DC

Diff. input threshold ± 0.2 V DC
voltage:
Diff. max. output voltage: 5 V DC
Diff. min. output voltage: 2 V DC
Short circuit output current: 100 mA
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.
Contact ratings:
Max voltage: 24 V AC or DC
Max current: 100 mA AC or DC
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.
External interface:
External connector P 64: 8 pin REDEL, grey. Attached cable length

2.0 m unshielded.
External equipment: Service purpose only.
Battery Back-up
Battery back-up of power 24 volt, 6.5 Ah
supply
Running time >15 minutes
Fuse T 15 A
Performance and specification - Supervisory
system
Note
• When accuracy ranges are written as e.g. “(±1 ml/min or ±1%)” the
Note
Blood Pressure Supervision

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

(±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)
System Pressure

(±10% at -700 to -500 mmHg)
(±5 mmHg or 3% at -500 to +500 mmHg)
(±10% at +500 to +750 mmHg)
Alarm limit SN/DP HIGH +300 mmHg (+175 mmHg)
max
Alarm limit SN/DP LOW -200 mmHg (+10 mmHg)
min.
Alarm limit SP HIGH max +750 mmHg (+150 mmHg)
Alarm limit SP LOW min. -
Alarm limit Low-Volume +750 mmHg (+150 mmHg)
HDF HIGH max
Alarm limit Low-Volume -300 mmHg (+100 mmHg)
HDF LOW min
Air Detection
Sensitivity Bubbles larger than 1 µl 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 22 mm
(diameter)
Heparin Administration
Heparinization volume ±0.3 ml of set value (±1 ml or 0.2 ml *
alarm limit heparinization time (h) or ±5%)
The accuracy is based on tests with 20 ml and 30 ml syringes
Dialysis fluid preparation

Temperature
Temperature alarm (fixed) 40 °C (±1 °C)
Conductivity
Alarm limits in Acetate ±5% of set value

mode
Alarm Limit in Bicarbonate ±5% of set value for A-step conductivity
mode, A-step
Alarm Limit in Bicarbonate ±5% of set value for B-step conductivity
mode, B-step
Alarm limits are temporarily extended to 10%. Maximum mean deviation
for a 5 hour treatment is 0.2 mS/cm.
Dialysis fluid preparation (BiCart Select mode only)

Dialysis Fluid Flow Rate 300 - 700 ml/min (±9 ml/min)
Dialysis Fluid Flow Rate ±5%
alarm limit
SelectBag Proportioning 1:400 ±12%, alarm given within 20
Ratio alarm limit minutes. For larger errors the alarm time
is shorter.
SelectBag Proportioning Ratio is defined
as the quotient SelectBag flow/dialysis
fluid flow
Ultrafiltration
Dialysis fluid flow operating 300 - 700 ml/min
range
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 ±1-10 ml/min, (±5 ml/min)
allowed difference between
control and protective
system, can be preset
(Default)
Accumulated UF volume ±0.10 - 2.0 l (±0.80 l) or ±0.10 l/h * passed
alarm limit, can be preset treatment time (h)
(Default)
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, TMP 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.
Substitution fluid (Low volume HDF)

Infusion volume supervision ±15% of calculated volume (±10%)
alarm
Blood leak detection

Sensitivity ≥0.35 ml blood/min, haematocrit 32%
±2%, at 700 ml/min dialysis fluid flow rate
Alarm response time 7 seconds
(diffusion mode)
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
Weight Fluid Monitor Approx. 40 kg
Weight Stand Approx. 24 to 31 kg
Infusion Stand Height 1300 to 2150 mm
Max. load 10 kg
Transportation One man installation
Fitting into a normal Estate car
References
Assembly Drawing: K22100
Materials in contact with water, concentrates
and dialysis fluid
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)
Metals
Stainless steel SS2343
Titanium
Platinum
Others
Carbon
Ceramic, Steatite 221
Ceramic, Aluminium oxide (Al2O3)
Ceramic, Zirconium oxide (ZrO2)
Glass
Ferrite (Barium-Strontium- Ferrit)
Environmental data
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.
Ambient Temperature range +18 to +35 °C

Relative Humidity range 15 to 85% RH
Air Pressure range (atm. 700 to 1060 hPa
pressure)
Maximum altitude ≈ 2000 m above see level
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. 500 to 1060 hPa
pressure)
Electromagnetic environment
The AK 200 S is intended for use in the electromagnetic environment specified below. The customer or the
user of the AK 200 S should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment – guidance
RF emissions Group 1 The AK 200 S uses RF energy only for its internal
CISPR 11 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 S is suitable for use in all establishments,
CISPR 11 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
IEC 61000-3-2 for 115 V version)
Voltage fluctuations Complies (Not
/flicker emissions applicable for 115 V
IEC 61000-3-3 version)
Immunity test IEC 60601 Compliance level Electromagnetic enviroment-guidance
test level
Electrostatic ±6 kV contact ±6 kV contact Floors should be wood, concrete or ceramic
discharge (ESD), ±8 kV Air ±8 kV Air tile. If floors are covered with synthetic
IEC 61000-4-2 material, the relative humidity should be at
least 30 %.
Electrical fast ±2 kV for power ±2 kV for power Mains power quality should be that
transisent/burst, lines lines of a typical commercial or hospital
IEC 61000-4-4 ±1kV for ±1kV for environment.
input/output lines input/output lines
Surge ±1KV for ±1KV for Mains power quality should be that of a
IEC 61000-4-5 differential mode differential mode typical commercial or hospital environment
±2kV for ±2kV for common
common mode mode
Voltage <5 % UT <5 % UT Mains power quality should be that
dips, short (>95 % dip in UT) (>95 % dip in UT) of a typical commercial or hospital
interruptions and for 0,5 cycle for 0,5 cycle environment. If the user of the AK 200 S
voltage variations 40 % UT 40 % UT requires continued operation during power
from power (60 % dip in UT) (60 % dip in UT) mains interruptions, it is recommended
supply input lines. for 5 cycles for 5 cycles that the AK 200 S be powered from an
IEC 61000-4-11 70 % UT 70 % UT uninterruptible power supply or a battery.
(30 % dip in UT) (30 % dip in UT)
for 25 cycles for 25 cycles
<5 % UT <5 % UT
(>95 % dip in UT) (>95 % dip in UT)
for 5 sec for 5 sec
Power frequency 3 A/m 3 A/m Power frequency magnetic fields should
(50/60 Hz) be at levels characteristic of a typical
magnetic field location in a typical commercial or hospital
IEC 61000-4-8 environment.
Note
• UT is the a.c. mains voltage prior to application of the test level.
Note
Portable and mobile RF communications equipment should be used no closer to any part of the AK 200 S,
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 d = 1.2 P
IEC 61000-4-6 150 kHz to 80
MHz
Radiated RF 3 V/m 3 V/m d = 1.2 P 80 MHz to 800
IEC 61000-4-3 80 MHz to 2,5
d = 2.3 P 800 MHz to 2,5 GHz
GHz
Radiated RF - 30V/m where P is the maximum output power
mobile phones rating of the 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
survey2, should be less than the compliance
level in each frequency range3.
Interference may occur in the vicinity of
equipment marked with the following
symbol:
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.
Note
2 Field 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 is used exceeds the applicable RF compliance level above, the AK 200 S
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.
3 Over the frequency range 150 kHz to 80 MHz, field strengths should be less than
3 V/m.
Recommended separation distances between portable and mobile RF communications equipment
and the AK 200 S
The AK 200 S 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 can help prevent electromagnetic interference
by maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the AK 200 S as recommended below, according to the maximum output power of the
communications equipment.
Rated maximum Separation distance according to frequency of transmitter
output power of (m)
transmitter
W
150kHz - 80MHz 80MHz - 800MHz 800MHz - 2500MHz
 3,5   3,5  7
d =  P d =  P d=  P
 3  3  3
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 - - 7
d=  P
output power of  30 
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.
Note
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
Chapter 14
Alarm list, Attention alarm list and

Technical alarm list
Alarm list . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14:2
Attention alarm list . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14:9
Technical alarm list . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14:45
Program version 8.xx AK 200 S Operator’s manual - Alarm 14:1
Alarm list
Light:
Steady
Mute time:
2 min
Additional information:
Low limit: blood pump stopped, venous clamp closed (only when blood
is detected).
High limit: blood pump stopped, in SN mode arterial clamp closed.
Buzzer only when blood is detected.
If necessary, it is possible to override the alarm actions, see "Override
possibilities" in chapter 3 of this manual.
Possible cause:
Low alarm: The blood line has separated from the dialyzer. The blood
line has separated at the arterial or venous side of the access. The position
of the venous needle has changed. Clotting before or in the dialyzer. The
blood flow rate has been reduced.
High alarm: The venous blood line is kinked or clamped. The position of
the venous needle has changed. Clotting has occurred after the venous
pressure measurement e.g. in the blood line, in the venous drip chamber
or in the needle.
Light:
Flashing
Mute time:
2 min
Alarm limits are too wide. After 2.5 min an attention also appears. Will
only appear when blood is detected.
Possible cause:
The alarm limits have been widened due to a started or stopped blood
pump or a change in the set blood flow.
14:2 AK 200 S Operator’s manual - Alarm Program version 8.xx
Light:
Steady
Mute time:
2 min
Temperature alarm. Dialysis Fluid bypassed. Buzzer only when blood
is detected
Possible cause:
Low alarm: The machine has not yet stabilized the temperature after
an interruption of the water supply. No power supply to the heating
elements.
High alarm: The temperature of the incoming water is too high. The
machine has not yet stabilized the temperature after the function check.
Light:
Steady
Mute time:
2 min
Dialysis fluid flow bypassed.
Buzzer only when blood is detected.
If conductivity is below 9 mS/cm the UF rate will automatically be set
to zero.
Possible cause:
Low alarm: The concentrate container/BiCart cartridge is empty. The
concentrate has not been connected. Incorrect concentrate has been
connected. The proper concentrate has not been selected on the display.
There is an interruption in the concentrate administration to the machine
e.g. the connector is not properly connected to the pick-up tube, the
concentrate line is kinked or occluded. Air is drawn into the machine
instead of concentrate. The filter(s) of the concentrate(s) is/are clogged.
The content of the concentrate container does not correspond to the
specifications given.
High alarm: Incorrect concentrate has been connected. The proper
concentrate has not been selected on the display. The content of the
concentrate container does not correspond to the specifications given.
Light:
Steady
Mute time:
2 min
Blood pump stopped, venous clamp closed. Buzzer only when blood
is detected.
Possible cause:
Low alarm: The arterial blood line is kinked or clotted between the
arterial access and the arterial pressure measurement. The set blood flow
rate exceeds the blood flow that the arterial access has possibility to
deliver. The position of the arterial needle has changed.
High alarm: The blood line has separated at the arterial side of the access.
The position of the arterial needle has changed. Air or infusion enters the
arterial line between the arterial access and the blood pump e.g. when a
pre blood pump infusion is connected.
Light:
Flashing
Mute time:
2 min
Possible cause:
The alarm limits have been widened due to a started or stopped blood
pump or a change in the set blood flow.
Light:
Steady
Mute time:
1 min
Buzzer only when blood is detected
Possible cause:
The TMP during treatment depends mainly on five parameters:
- UF-coefficient of the dialyzer
- treatment time
- UF-volume
- blood flow
- if HDF, infusion volume
Changes in TMP during treatment depends on several different things:
- changed UF value
- changed treatment time
- the condition of the dialyzer
- the substitution fluid volume during HDF treatment
- changes in the UF-control system that can cause reduced accuracy in the
weight loss of the patient
- change of blood flow
The changes can cause both high- and low TMP alarms.
Low alarm:
- the set value for the treatment time has been increased
- the set value for the UF volume has been decreased
- decreasing venous pressure
- decreased substitution fluid volume, during HDF
weight loss of the patient.
High alarm:
- the set value for the treatment time has been decreased
- the set value for the UF volume has been increased
- increasing venous pressure
- partly or complete clogged dialyzer
- increased substitution fluid volume, during HDF, can lead to a UF-rate
that is too high in proportion to the blood pump flow
weight loss of the patient.
Light:
Flashing
Mute time:
2 min
Possible cause:
The alarm limits have been widened due to
- a started or stopped blood pump
- changed treatment time
- changed UF volume
- started or stopped ultrafiltration
Light:
Steady
Mute time:
2 min
Blood pump stopped, venous and arterial clamps closed. Buzzer only
when blood is detected.
Adjust the level in the venous drip chamber by using the level adjustment
buttons. If necessary (particularly when performing single needle/double
pump), it is possible to override the alarm actions, see “Override
possibilities” in chapter 3 of this manual.
Possible cause:
Blood line(s) not properly connected at e.g. the arterial needle connection,
the dialyzer connection(s), the infusion port(s). Blood line(s) or the
dialyzer not properly de-aired during priming. An empty infusion
container with air inlet is connected to the blood line(s). The arterial
needle is dislocated.
Light:
Flashing
Mute time:
2 min
Air has been detected. The fault has been rectified, but the Air detect button
must be pressed in order to reset the alarm and to continue the treatment.
Possible cause:
-
Light:
Steady
Mute time:
2 min
The ∆BV is below the set alarm limit.
Possible cause:
The ultrafiltration rate or the accumulated ultrafiltration volume, tolerated
by the patient, has been exceeded.
Light:
Steady
Mute time:
2 min
Dialysis fluid flow bypassed. Buzzer only when blood is detected
Possible cause:
The content of the concentrate container does not correspond to the
specifications given. Incorrect concentrate has been connected. Either
the acid container or the bicarbonate container/BiCart cartridge has been
emptied during bicarbonate treatment.
Light:
Steady
Mute time:
2 min
Blood pump stopped, arterial and venous clamps closed. Dialysis fluid
flow bypassed, UF rate is automatically set to zero (only when blood
is detected).
Possible cause:
A leakage, which allows blood to flow from the blood compartment to
the dialysis fluid compartment, has occurred in the dialyzer. Air bubbles
or particles, which can cause a false blood leak alarm, have entered the
blood leak detector.
Light:
Flashing
Mute time:
2 min
A blood leak has been detected. The fault has been rectified, but
the Blood leak button must be pressed in order to reset the alarm and to
continue the treatment.
Possible cause:
-
Light:
Steady
Mute time:
2 min
The treatment time has expired. An attention appears simultaneously.
Possible cause:
Treatment time has expired.
Light:
Steady
Mute time:
2 min
System pressure too high or system pressure too low. See attention
message
Possible cause:
-
Light:
Steady
Mute time:
2 min
UF volume too high. See attention message.
Possible cause:
-
Attention alarm list
The attentions are described in alphabetical order.
A-PICK UP TUBE
IMPROPER POSITION
Mute time:
2 min
Buzzer is delayed 2 min. Check pick-up tube and mode.
ABSENT HEATER SUPPLY VOLTAGE

Check fuses and connector
Mute time:
2 min
Will only appear during disinfection
a) Check cable between fluid monitor and power supply unit
b) Check fuses in power supply unit
ADJUST PUMP HEAD TO TUBE 0.00

Press BLOOD FLOW key to confirm
Mute time:
Infinite
After the diameter of the blood pump segment has been changed, this
attention alarm will occur when the blood pump is started again.
AIR DETECTOR NOT ACTIVATED

Press AIR DETECTOR key
Mute time:
Infinite
Will only appear during priming.
ARTERIAL PRESSURE LIMITS ADJUST
Press ARTERIAL key
Mute time:
2 min
Alarm limits are too wide: will only appear when blood is detected.
ARTERIAL PUMP COVER NOT CLOSED

Close cover
Mute time:
2 min
Blood pump stopped.
Venous clamp closed.
ARTERIAL PUMP OVERLOAD

Press BLOODPUMP key
Mute time:
2 min
Blood pump stopped.
Venous clamp closed.
ARTERIAL PUMP REVOLUTION HIGH

Check cause, press BLOOD PUMP key
Mute time:
2 min
Blood pump stopped, venous clamp closed.
Check for kinks on arterial blood line
a) Check arterial blood flow, when necessary decrease
b) Decrease high system pressure limit
c) Decrease stroke volume
B/ACETATE - PICK UP TUBE
IMPROPER POSITION
Mute time:
2 min
Buzzer is delayed 2 min. Check pick-up tube and mode
BATTERY FAILURE
Press LOW to confirm further use
Mute time:
Infinite
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
backup 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.
BLOOD LEAK DETECTOR FAILURE

Clean and press BLOODLEAK key
Mute time:
Infinite
Will only appear during Fch.
For cleaning instructions, see "Maintenance - the exterior of the machine",
"Blood leak detector", chapter 12, in this manual.
BLOOD MONITOR TEMPERATURE ALARM

Insufficient internal cooling
Mute time:
2 min
Check FAN filter on left hand side
BLOOD PUMP(S) STOP TIME EXPIRED
Press BLOODPUMP key
Mute time:
2 min
Appears after 1 min: will only appear when blood is detected
BPM FAILURE
Turn off BPM
Mute time:
Infinite
An error is detected by the BPM. Turn the BPM off and then on again.
BPM PRESS. OUTSIDE ALARM LIMITS

Check patient and press BPM key
Mute time:
Infinite
Blood pressure measurement values is outside the set alarm limits. Check
patient. Confirm by pressing the flashing BPM button. The BPM screen
will then be shown and the measured numerical values outside the set
alarm limits will be flashing.
BVS DOOR OPEN

Close door
Mute time:
2 min
Buzzer delayed 2 min. The BVS door has to be closed during self test,
priming and treatment.
Close the BVS door.
BVS FAILURE
Switch off BVS
Mute time:
2 min
An error has been detected by the BVS.
Turn the BVS off to continue the treatment. The cause of the attention
alarm can either be that the patient’s Hemoglobin value is outside the
specified range for the BVS to be active or a technical BVS error. If a
technical error is suspected, note the two-figure number to the right of
the attention text before turning off the BVS. Inform the technician
responsible for the machine.
BVS LOW BLOOD FLOW

Increase blood flow
Mute time:
2 min
If possible, increase the blood flow rate. If this is not possible, turn the
BVS off to continue the treatment.
BVS SELF TEST

Remove cuvette
Mute time:
2 min
Buzzer delayed 2 min.
Appears during the function check of the blood monitor. The BVS self
test is to be performed with an empty holder. Remove the BVS cuvette
from the holder.
BiCart EMPTY
Check or replace BiCart
Mute time:
2 min
If BiCart is to be replaced close both latches, open and attach new BiCart.
Priming will then be done automatically.
BiCart HOLDER NOT CLOSED
Close or check BiCart holder
Mute time:
2 min
Buzzer is delayed 2 min.
BiCart NOT ATTACHED TO HOLDER

Attach or check BiCart
Mute time:
Infinite
Check if BiCart cartridge is empty. Check that the BiCart cartridge is
properly primed by the machine, if not, remove the cartridge, close the
latches and attach the cartridge again. If the BiCart cartridge is properly
primed and there are no visual leakage, press the Arrow button below
HIGH to continue.
BiCart NOT ATTACHED TO HOLDER

Attach/check BiCart, press HIGH
Mute time:
2 min
Appears only in function check.
Check that the BiCart cartridge is properly primed by the machine, if not,
remove the cartridge, close the latches and attach the cartridge again.
CAN NOT APPLY DOWNLOADED PARAM.

All parameters must be rejected
Mute time:
Infinite
Appears if any treatment parameter or value in the downloaded list is
not accepted by the machine. The complete list of parameters must be
rejected. Press the Clinic automation button to check which parameter,
shown in red, cannot be set. Redo the downloading after changing the
parameter or set all parameters manually. It is important to note that the
downloaded settings for concentrates have not been automatically set.
CENTRAL CHEM DISINF. COMPLETED
Press Rinse/Drain key
Mute time:
Infinite
Will appear when the preset dwell time in central disinfection has passed.
CHANGE OF TREATMENT MODE FAILED

Mute time:
Infinite
Appears when the machine was not able to automatically set treatment
mode after acceptance of downloaded treatment parameters. Check
treatment mode, activate manually if necessary.
CHECK FLUID TUBES FOR LEAKAGE

Press LOW to confirm
Mute time:
2 min
Appears only in function check.
Check that the dialysis fluid tubes are properly attached to the machine.

Mute time:
2 min
-
CLEARANCE TOO LOW
Mute time:
Infinite
The measured clearance value is below the alarm limit set.
Check cause, adjust treatment parameters to increase clearance or adjust
alarm limit for clearance.
The alarm limit for clearance is changed by pressing the Kt/V button once
(to reach the first Diascan screen). Then press the lit Arrow button below
K LIMIT and adjust by using the Set knob.
CONC. SETTINGS NO LONGER DEFAULT

Mute time:
Infinite
Appears after rejection of the downloaded treatment parameter list,
when the downloaded concentrate settings differ from the settings which
the machine started up with. The machine has automatically set the
downloaded concentrate settings. To continue, press the lit Arrow button
to confirm the downloaded settings. Select and connect new concentrates
manually as is the usual procedure.
CONDUCTIVITY MEASURED
Check concentrate supply
Mute time:
2 min
Appears when performing disinfection program, it is not possible for the
machine to rinse out remaining concentrates.
Check concentrate connections.
If function check has not been performed prior to the disinfection
program, and the inlet water conductivity is higher than 0.5mS/cm,
the machine must be restarted. After restart, the function check must
continue until an attention alarm appears indicating high inlet water
conductivity. After confirmation of this attention alarm, restart the
disinfection program.
Attach or check CleanCart
Mute time:
2 min
-
DECALCIFICATION REQUIRED
XX hours since last decalc
Mute time:
Infinite
Will disappear as soon as priming is activated.
The period of time between the last performed decalcification and the
appearance of the attention alarm can be preset.
DIALYSER UF-COEFF TOO SMALL

Decrease infusion SET value
Mute time:
Infinite
The "total" UF value cannot be achieved due to e.g.
a) Too small dialyzer
b) Clotted dialyzer
DISCONNECT ARTERIAL PRESSURE

Press ART PRES key to confirm
Mute time:
2 min
Further function check stopped. May appear during function check when
blood lines are attached.
DISCONNECT SYSTEM PRESSURE
ress SN DATA key to confirm
Mute time:
2 min
DISCONNECT VENOUS PRESSURE

Press VENOUS key to confirm
Mute time:
2 min
DISINFECTION REQUIRED
XX days since last disinfection
Mute time:
Infinite
Will disappear as soon as priming is activated.
The period of time between the last performed disinfection and the
appearance of the attention alarm can be preset.
Diascan FAILURE
Turn OFF Diascan
Mute time:
Infinite
During function check:
Appears when there is a technical error of the Diascan function; it is
not possible to use the Diascan. Turn the Diascan off by pressing the
Kt/V button once (to reach the first Diascan screen). Then press the lit
Arrow button below Diascan and turn the Set knob anticlockwise until
OFF appears. Contact an authorized service technician.
During treatment:
Appears when too many Diascan steps have been done during that
particular treatment. Performing further Diascan steps may lead to an
imbalance in the sodium level of the patient. The Diascan function is not
permitted to perform any more measurement checks. Turn the Diascan
off by pressing the Kt/V button once (to reach the first Diascan screen).
Then press the lit Arrow button below Diascan and turn the Set knob
anticlockwise until OFF appears. If this attention appears frequently,
discuss preset limits with an authorized service technician.
Diascan IN PROGRESS
To change param, cancel Diascan
Mute time:
1 min
Appears when one of the following treatment parameters are changed at
the same time as a measurement check is in progress:
- sodium and bicarbonate (conductivity)
- temperature
- dialysis fluid flow
- UF volume
- profiling settings
- isolated UF activation
It is not possible to change the treatment parameter.
If possible, leave the attention without immediate action (i.e. just
silence the buzzer by using the Mute button), the attention will disappear
automatically within 30 seconds. Change the parameter when the
measurement check is complete.
If the treatment parameter must be changed immediately, turn the
Diascan off by pressing the Kt/V button once (to reach the first Diascan
screen). Then press the lit Arrow button below Diascan and turn the
Set knob anticlockwise until OFF appears. It is possible to activate the
Diascan again when the treatment parameter has been changed. The
Diascan will then be rescheduled.
Diascan MEASUREMENT FAILED
Press Kt/V to confirm
Mute time:
Infinite
The machine was not able to perform the measurement check.
Confirm by pressing the flashing Kt/V button.
If desired, reactivate the measurement check.
Diascan NOT ACTIVE

No measurement possible. Confirm
Mute time:
Infinite
Appears when the Diascan is activated in Isolated UF mode. The Diascan
function cannot perform measurement checks. This attention can also
appear when an attempt to reactivate the Diascan is made after a Diascan
failure attention has previously occurred.
Confirm by pressing the flashing Kt/V button.
Diascan RESCHEDULED
Mute time:
No buzzer
Appears when one of the following is done at the same time as a
measurement check is in progress:
- the blood flow rate is changed
- the Blood pump button is pressed
- the Start UF Stop button is pressed
- the Fluid bypass button is pressed
- a treatment alarm that produces dialysis fluid bypass or blood pump
stop is generated
The machine was not able to completely perform the measurement check
as the measurement check has been interrupted. Confirm by pressing
the flashing Kt/V button and the machine will automatically reschedule
measuring as soon as possible.
Close holder
Mute time:
2 min
Open the upper latch of the holder and wait until the CleanCart has been
emptied. Remove the CleanCart and close the holder.
This attention can be removed by preset.

Mute time:
2 min
If this attention appears during initiation of the treatment, check that the
venous blood line is properly inserted into the priming detector.
If this attention appears during priming, the set extra priming volume
has been achieved.
Note that the buzzer can be muted for 2 min if the blood pump is
running; if the blood pump is not running, the buzzer will be muted until
the blood pump is started again1.
FLUID BYPASS TIME EXPIRED

Press BYPASS key
Mute time:
2 min
Appears after 5 min: will only appear when blood is detected.
FLUID MONITOR TEMPERATURE ALARM

Insufficient internal cooling
Mute time:
2 min
Check FAN filter at the rear.
12 min mute time when the blood pump is not running can be preset
FLUID PATH OBSTRUCTION
Check drain tube
Mute time:
2 min
A "blockage" has been detected. Check drain tubing.
FLUID PATH OBSTRUCTION

Check tubes and dialyzer paths
Mute time:
2 min
A "blockage" has been detected.
Check if particle filter after dialyzer is "clogged" by pressing
Fluid bypass button - if attention disappears, the cause is probably the
particle filter.
FLUID TUBES IN SAFETY BYPASS

Check position of fluid tubes
Mute time:
Infinite
Appears if the tubings are attached to the machine when blood is detected.
FLUID TUBES NOT IN SAFETY BYPASS
Mute time:
2 min
Disinfection mode cannot be started.
FUNCTIONAL CHECK STOPPED
Remove line from primingdetector
Mute time:
2 min
The priming detector detects blood during blood monitor function check.
Remove blood filled line from priming detector. If priming detector is
malfunctioning, call for technical service.
HDF KEY ERROR

Press technical alarm key
Mute time:
2 min
Technical error concerning HDF key.
If confirmed with technical alarm key it is possible to continue in HD
mode.
HEPARIN PUMP OVERLOAD

Check syringe and tube
Mute time:
2 min
Heparin pump stopped.
Syringe empty?
HIGH INLET WATER COND x.xmS/cm
Press LOW to confirm low K+
Mute time:
2 min
Appears during function check if the inlet water conductivity is between
0.5 and 2.5 mS/cm.
When this attention alarm appears, the operator must consult the
attending physician before the attention alarm is confirmed and a
treatment is started. It will not be possible to start a treatment until the
attention alarm is confirmed.
Depending on the inlet water conductivity, minor electrolytes
concentration (potassium, calcium, magnesium) will be reduced by 4 -
20% in the dialysis fluid.
This attention alarm can only appear if it is possible to run the machine
with inlet water conductivity above 0.5 mS/cm.
HIGH SYSTEM PRESSURE ALARM
Mute time:
2 min
Blood pumps stop.
Clotted dialyzer?
Wrong insertion of the pump segments?
May appear after treatment in double pump mode when the discontinuing
is performed in single pump mode, without having removed the venous
pump segment from the pump.
INCONSISTENT UF-RATE PARAMETERS

Check parameter settings
Mute time:
2 min
Calculated UF-rate is either below min UF-rate or above max UF-rate
(4 l/h)
a) Increase UF-rate by adjusting time or UF volume when set UF-rate is
below min UF-rate
b) Decrease min UF-rate
c) Decrease UF-rate by adjusting time or UF volume when set UF-rate
is above max limit (4 l/h)
INCORRECT ACETATE CONCENTRATE
Check concentrate fluid
Mute time:
2 min
Dialysis fluid flow bypassed
INCORRECT ACIDIC CONCENTRATE

Mute time:
2 min
INCORRECT AUTO DISINFECTION TIME

Check ready time parameters
Mute time:
2 min
Real time and ready time are too close?
INCORRECT BICARBONATE CONC

Mute time:
2 min
INCORRECT CLEANING AGENT
Check cause, press HEAT key
Mute time:
2 min
An insufficient citric acid amount or incorrect selection of cleaning agent
has been detected, check cause and press HEAT key shortly to repeat
fill phase.
If the RINSE key is pressed for 3 seconds, a post chemical rinse will start.
INCORRECT CLEANING AGENT

Check cause, press RINSE key
Mute time:
2 min
An incorrect concentration or incorrect selection of cleaning agent has
been detected, check cause.
INCORRECT CONDUCTIVITY MEASURED

Check concentrate supply
Mute time:
2 min
Function check stopped. Will only appear during function check
INCORRECT DISINFECTANT
Check cause, press CHEM key
Mute time:
2 min
A too low disinfectant concentration has been detected, check cause and
press CHEM key shortly to repeat fill phase.
INCORRECT DISINFECTANT
Check cause, press RINSE key
Mute time:
2 min
A too high disinfectant concentration has been detected, check cause and
press RINSE key shortly to repeat fill phase.
INCORRECT MAIN FLOW
Mute time:
2 min
Appears when the BiCart Select system is being used. The protective and
control systems for dialysis flow rate are not in agreement.
To continue treatment if the attention remains, exchange the SelectCart
and SelectBag for an acidic concentrate. Press the Bicarbonate button once
to change concentrate alternative.
Call for an authorized technician for trouble shooting to ensure further
use with the Bicart Select system.
INCORRECT SelectBag FLOW

Check SelectBag
Mute time:
2 min
Check holder for leakage or air at the top of SelectBag. Remove and
replace an empty SelectBag
INCORRECT SelectCart CONCENTRATE

Check or replace SelectCart
Mute time:
2 min
Dialysis fluid flow bypassed.
INCORRECT UF PARAMETER(S)
Check parameter settings
Mute time:
Infinite
Buzzer is delayed 2 min. Max positive/negative pressure limit has been
reached
a) Increase UF-rate by adjusting time or UF volume (negative TMP)
b) Decrease UF-rate by adjusting time or UF volume (positive TMP)
INFUSION PUMP FAILURE

Deactivate HDF to continue
Mute time:
2 min
Protective system is not in agreement with control system about the
speed of the infusion pump.
This means that the patient’s weight loss during treatment might be
incorrect.
The infusion pump and ultrafiltration are stopped.
Press the HDF button for 3 seconds to confirm the alarm and
simultaneously deactivate the HDF treatment.
Do customary patient checks.
To continue treatment:
A calculation of the true infusion volume up to when the attention alarm
occurred has to be made.
Weigh the infusion bags in order to roughly estimate how much infusion
fluid has been infused so far. Exclude the priming volume. Check, at the
same time, the accumulated infusion volume measured by the control
system by pressing the HDF button.
Calculate the difference and adjust the set UF volume (patient weight loss)
in order to achieve the correct weight loss for the patient. If possible, also
weigh the patient in order to ensure that the calculation is correct.
Continue the treatment in HD mode.
CAUTION
Incorrect weight loss may occur if confirmation of the alarm is done
without adjusting the set UF volume for the rest of the treatment.
CAUTION
INFUSION RATE LESS THAN XX.X L/H
Adjust SET value
Mute time:
2 min
0.3 l/h is the min "total UF-rate". When infusion volume + UF volume
= less than 0.3 l/h, this attention appears.
INFUSION RATE MORE THAN XX.X L/H

Adjust SET value
Mute time:
2 min
It is not possible to set the infusion rate above 2.1 l/h.
INFUSION VOLUME DEVIATION
Check cause, press HDF key
Mute time:
2 min
HDF procedure stops.
Protective system has detected that the accumulated infusion volume
during treatment measured up to this point is incorrect.
This means that the patient weight loss during treatment is incorrect. The
infusion pump and ultrafiltration are stopped.
Check the infusion line and infusion bags for e.g. kinks.
Press the HDF button for 3 seconds to confirm the alarm and
simultaneously deactivate the HDF treatment. Do customary patient
checks.
To continue treatment:
A calculation of the true infusion volume up to when the attention alarm
occurred has to be made. Weigh the infusion bags in order to roughly
estimate how much infusion fluid has been infused so far. Exclude the
priming volume. Check, at the same time, the accumulated infusion
volume measured by the control system by pressing the HDF button.
Calculate the difference and adjust the set UF volume (patient weight loss)
in order to achieve the correct weight loss for the patient. If possible, also
weigh the patient in order to ensure that the calculation is correct.
If the fault is rectified (e.g. a kinked line) it is possible to continue
the HDF treatment. In this case, activate HDF again by pressing the
HDF button for 3 seconds. If the attention reappears, deactivate HDF and
redo the calculation as above. If it is not possible to rectify the fault,
continue the treatment in HD mode.
CAUTION
Incorrect weight loss may occur if confirmation of the alarm is done
without adjusting the set UF volume for the rest of the treatment.
CAUTION
INSUFFICIENT DISINFECTANT
Check disinfectant supply
Mute time:
2 min
Check pick up tube and disinfectant container.
INSUFFICIENT WATER SUPPLY
Check water supply
Mute time:
2 min
The blood flow rate is decreased. It is however possible to increase the
blood flow during the alarm state. Check water supply.
ISOLATED UF PHASE COMPLETED

Press ISOL UF key to complete
Mute time:
Infinite
When the remaining time is 0.00 after isolated UF phase, this attention
will occur and remain until the Isol UF button has been released.
Kt/V FORECAST TOO LOW
Mute time:
Infinite
Kt/V forecast value is below the Kt/V alarm limit set.
Check cause, adjust treatment parameters or adjust the alarm limit for
Kt/V. This is done by pressing the Kt/V button twice (to reach the second
Diascan screen). Then press the lit Arrow button below LIMIT and adjust
by using the Set knob.
Kt/V TARGET ACHIEVED

Mute time:
Infinite
The set target value for Kt/V has been reached.
Confirm by pressing the flashing Kt/V button. It is also possible to
increase the Kt/V target value, and the machine will recalculate time
to target. This is done by pressing the Kt/V button twice, (to reach the
second Diascan screen). Then press the lit Arrow button below TARGET
and adjust by using the Set knob.
LIMITED INPUT PUMP CAPACITY
Adjust UF/TMP parameters
Mute time:
2 min
AK 200 S cannot produce the min or max dialysis fluid pressure that
is required
a) Check for possible obstructed drain tube
b) Check UF volume and UF rate
c) If the attention remains, call for technical service.
CAUTION
Incorrect weight loss may occur if the machine is left for a longer
period with this attention.
CAUTION
LIMITED OUTPUT PUMP CAPACITY

Adjust UF/TMP parameters
Mute time:
2 min
AK 200 S cannot produce the min or max dialysis fluid pressure that
is required
a) Check UF volume and UF rate
b) If the attention remains, call for technical service.
CAUTION
CAUTION
LOW BATTERY POWER

Machine turns off in one minute
Mute time:
Infinite
-
LOW FLOW HEAT ABORTED
Press lit arrow to confirm
Mute time:
Infinite
This attention alarm appears when performing integrated Heat
disinfection program with WRO 300 H. The Low Flow Heat phase
(where the machine receives hot water from the WRO 300 H) will not
start.
Press the lit Arrow button to confirm the attention alarm. The AK 200 S
now enters drain phase as the circulation phase of the Heat disinfection
program is complete. Call for an authorized technician.
For information about the integrated Heat disinfection program with
WRO 300 H, see the corresponding handling instructions for the
program in chapter 12 of this manual.
LOW SYSTEM PRESSURE ALARM

Check infusion bag
Mute time:
2 min
HDF procedure stops.
Check infusion line. Check if infusion bag is empty.
MAJOR AIR LEAKAGE

Check fluid connectors and tubes
Mute time:
2 min
Dialysis fluid flow bypassed, dialysis fluid pressure: -50 mmHg.
CAUTION
CAUTION
MEAN BLOOD FLOW TOO LOW
Check settings
Mute time:
2 min
Measured blood flow is less than 70% of set blood flow.
MINOR AIRLEAKAGE
Check fluid connectors and tubes
Mute time:
Infinite
NEGATIVE UF RATE
Check and press UF volume
Mute time:
2 min
Relative negative UF volume of 500 ml or negative UF rate >50 ml/min
for 5 min. Check for "blockage" of the draining tube. After correction of
the fault, press the UF volume button for 3 sec. for confirmation. Check
the UF rate before leaving the machine, if this is not correct call for
technical service.
CAUTION
having corrected the cause for the attention.
CAUTION
NEW ULTRA FILTERS REQUIRED

Replace ULTRA filters
Mute time:
Infinite
Will disappear as soon as priming is activated. See "Ultrafilters; how to
change" in the “Hygiene and maintenance" chapter.
NO BACK-FILTRATION WARNING
Press TMP to confirm
Mute time:
2 min
The TMP low alarm limit is set below zero mmHg and no backfiltration
warning will occur. This attention needs confirmation.
This attention alarm can be activated by preset.
NO BPM VALUES
Check BPM cuff
Mute time:
Infinite
It was not possible to measure the patients blood pressure. Check that
the cuff is correctly applied to the patient. It could also be that the patient
is moving during the measurement check.
NO CHANGE IN BLOOD PRESSURE

Check cause, press BLOODPUMP key
Mute time:
2 min
Blood pump stopped, venous clamp closed.
May appear just before "arterial revolution too high" attention.
a) Kinks on system pressure transducer protector?
b) Clotted discfilter?
c) Clotted dialyzer?
d) Check that the venous blood pump segment is inserted in the pump
housing
NO CUFF ATTACHED
Attach or check BPM cuff
Mute time:
Infinite
Check for kinks or leakage from the cuff and the cuff hose. Check also
that the cuff hose is properly connected to the machine.
NO CUVETTE IN BVS
Insert cuvette or switch off BVS
Mute time:
2 min
Buzzer delayed 2 min. The cuvette of the blood line is not inserted in
the holder or a blood line without a cuvette is used. In the later case
turn the BVS off.
NO HEPARIN VALUE SET

Press HEPARIN key to confirm
Mute time:
2 min
An attention also appears simultaneously.
POWER FAILURE, BATTERY OPERATION

Battery operated for XX minutes
Mute time:
Infinite

Mute time:
No buzzer
The blood pump stops. (If SN/double pump or HDF has been activated,
the venous/infusion pump also stops.)
If this attention appears during initiation of the treatment, check that the
venous blood line is properly inserted into the priming detector.
PULSE RATE OUTSIDE ALARM LIMITS
Check patient and press BPM key
Mute time:
Infinite
Pulse rate measurement value is outside the set alarm limits.
Check patient. Confirm by pressing the flashing BPM button. The BPM
screen will then be shown and the measured numerical value outside
the set alarm limits will be flashing.
RECOVERED FROM POWER-FAILURE

Mute time:
2 min
When Time is confirmed, both Blood leak as well as Air detect buttons have
to be pressed in order to start again.
RECOVERED FROM TECHNICAL RESTART

Mute time:
2 min
Appears after an automatic restart.
When Time is confirmed, both Blood leak as well as Air detect buttons have
to be pressed in order to start again
STROKE VOLUME NOT ACHIEVED

Check blood line setup
Mute time:
2 min
May appear if high system pressure limit was decreased too rapidly.
a) Check for kinks on venous blood line
b) Check system pressure change during whole phase. Adjust high system
pressure limit.
STROKE VOLUME NOT ACHIEVED
Check cause, press SN DATA key
Mute time:
2 min
a) Check/adjust level in expansion chambers
b) Check/adjust system pressure window
d) Check/adjust blood pump segment setting
SelectBag FLOW NOT CALIBRATED

Change concentrate alternative
Mute time:
2 min
Protective and control system do not agree about the SelectBag flow.
Press the Bicarbonate button once to change concentrate alternative.
SelectBag HOLDER
IMPROPER POSITION
Mute time:
2 min
Buzzer is delayed 2 min. Check holder position.
SelectCart HOLDER NOT CLOSED

Close or check SelectCart holder
Mute time:
2 min
SelectCart NOT ATTACHED
Attach or check SelectCart
Mute time:
Infinite
TMP LIMITS ADJUST

Press TMP key
Mute time:
2 min
Alarm limits are too wide: will only appear when blood is detected
TOTAL UF-RATE TOO HIGH

Adjust blood flow/infusion volume
Mute time:
Infinite
If a too low blood flow in combination with a too high "total UF rate" is
set, this attention appears. Max "total UF rate" is 30% of set blood
flow.
TREATMENT STOP TIME EXPIRED

Press START UF key
Mute time:
2 min
Appears after 5 min: will only appear when blood is detected
TREATMENT TIME EXPIRED
Mute time:
2 min
When the flashing Time button is pressed, end of treatment will be
confirmed and the TMP alarm limits will widen.
UF RATE HIGHER THAN EXPECTED

Adjust UF parameters
Mute time:
2 min
Min UF-rate is reached
a) Increase UF-rate by adjusting time or UF volume
b) Decrease min UF-rate
UF RATE LIMIT REACHED

Re-adjust time or UF volume
Mute time:
2 min
UF volume cannot be achieved within remaining time even though +20%
limit on UF-rate is used
a) Increase UF-rate limit (+20%) by pressing UF volume arrow for set
(a new limit is calculated)
b) Decrease UF-rate by adjusting time or UF volume
UF SELF TEST FAILED

New test within 5 min
Mute time:
No buzzer
Will only appear during Fch, the function check will be prolonged.
UF VOLUME DEVIATION
Mute time:
2 min
The protective system accumulated measured UF volume (SUPERV) is
outside LOW or HIGH limit. The ultrafiltration is stopped and the blood
flow is decreased. It is however possible to increase the blood flow during
the alarm state.
Check the machine for visual leakage.
Check accumulated UF volume in both control and protective system.
Check alarm limits for UF volume in protective system.
Do customary patient checks as whenever the ultrafiltration volume
is suspected to be incorrect. Evaluate if it is possible to continue the
treatment. Confirm by pressing the UF volume button for 3 sec. After
confirmation the estimated accumulated UF volume is recalculated in
protective system. (See “Protective system for ultrafiltration" in chapter
3). If problem remains call for technical service.
This attention can be removed by preset.
CAUTION
CAUTION
UF VOLUME DEVIATION: NEGATIVE UF

Mute time:
2 min
The protective system UF volume is more than 500 ml negative.
Check for "blockage" of the draining tube. Confirm by pressing the
UF volume button for 3 sec. If problem remains call for technical service.
CAUTION
CAUTION
UF VOLUME HIGHER THAN EXPECTED
Adjust time or UF volume
Mute time:
Infinite
Max positive dialysis fluid pressure is reached (negative TMP).
a) Partly clotted dialyzer?
b) Partly kinked venous blood line?
c) Technical problem? Correct the cause.
d) Check UF volume and UF rate
CAUTION
having corrected the technical cause for the attention alarm. If
problems remains contact service technician.
CAUTION
UF VOLUME LOWER THAN EXPECTED

Adjust time or UF volume
Mute time:
Infinite
Max negative dialysis fluid pressure is reached (positive TMP).
a) Partly clotted dialyzer or too small dialyzer?
b) Technical problem? Correct the cause.
c) Check UF volume and UF rate
CAUTION
having corrected the technical cause for the attention alarm. If
problems remains contact service technician.
CAUTION
UF VOLUME TOO HIGH

Re-adjust time or UF volume
Mute time:
2 min
The accumulated UF volume differs > 200 ml from the calculated
volume. The blood flow will be decreased.
UNSTABLE CONDUCTIVITY
Check SelectCart, press HIGH
Mute time:
2 min
Appears in function check. It was not possible to complete conductivity
test. The function check has been stopped.
Check that the SelectCart cartridge is properly attached to SelectCart
holder.
Check for possible air leakage where the cartridge is attached into the
holder.
Confirm by pressing the lit HIGH Arrow button.
VENOUS PRESSURE LIMITS ADJUST

Press VENOUS key
Mute time:
2 min
Alarm limits are too wide: will only appear when blood is detected
VENOUS PUMP COVER NOT CLOSED

Close cover
Mute time:
2 min
Blood pump stopped, venous clamp closed
VENOUS PUMP OVERLOAD

Press BLOODPUMP key
Mute time:
2 min
Blood pump stopped, venous clamp closed
WRO COMMUNICATION FAILURE
Check WRO
Mute time:
Infinite
The communication between the AK 200 S and the WRO has stopped.
Call for an authorized technician.
WRO NOT READY

Please wait
Mute time:
Infinite
Appears during function check, please wait. WRO inaccessible, check
information on WRO.
Technical alarm list
ERROR! CALL SERVICE
Call service to investigate cause of alarm and the possibility of continuing
treatment.
In case of a technical error in the fluid monitor during treatment the
blood flow will be decreased. It is however possible to increase the blood
flow during the alarm state.
WARNING
A restart attempt after technical error during treatment may create a
potential hazard for the patient.
WARNING
ERROR! RESTART OR CALL SERVICE
A restart attempt can be made before calling service.
TECHNICAL ERROR BUZZER

Continued use confirmed
The technical symbol will remain lit during the treatment. When pressed,
this information will be displayed.
TECHNICAL ERROR BUZZER

Press LOW to confirm further use
One of the two buzzers is broken. The treatment can be completed and
technical service should in this case be carried out after the treatment. In
order to confirm further use, the left lit Arrow button should be pressed
(LOW).
TECHNICAL ERROR HEPARIN PUMP
Heparin pump not in use
The technical symbol will remain lit during the treatment. When pressed,
this information will be displayed.
TECHNICAL ERROR HEPARIN PUMP

Zero set value to continue
The heparin pump is broken. The treatment can be completed if the
heparin set value is adjusted to 0.0.
When suitable, call for technical service.
Chapter 15
Major changes in operator’s manual
Program version 8.xx AK 200 S Operator’s manual - Major changes 15:1
Major changes between program version
7.xx and 8.xx
Chapter 1
A new section has been included; "How to use this manual". This is
a brief explanation of how the chapters in the manual are structured
and how they are intended to be used. A new manual symbol is also
introduced in this section, in "Definitions of expressions used in this
manual". The symbol; , indicates that it is possible to preset the value
of a parameter, and appears throughout the manual.
Chapter 2
A small text has been added in the "Blood monitor" section, position 11.
The level adjustment buttons are now only active for maximum 6 seconds
at a time, when pressed and hold.
Chapter 3
A small information has been included in the "Concentrate stand-by
mode" section, concerning the fact that the fluid flow is automatically
decreased to 100 ml/min when Concentrate stand-by mode is active, to
minimize the water consumption. As a consequence, it will now take one
minute longer for the dialysis fluid preparation to be resumed.
The section "Override possibilities" has been updated, especially note

the new information about changed machine actions during air detector
alarm override.
A new section has been added; "Downloading treatment parameters" as

it is now possible to download certain treatment parameters from an
external computer system.
"BiCart/SelectCart change during treatment" has been rewritten.

Information is included about the fact that the priming process of the
cartridge is indicated by a cartridge symbol in the upper right corner
of the information display.
Chapter 4
The section "Discontinuing" has been rewritten and updated with new
instructions for the discontinuing procedure. If the BiCart Select system
or the BiCart cartridge has been used during treatment, and if desired,
the emptying procedure of the containers can now be started at any
time during the discontinuing procedure after treatment end has been
confirmed.
15:2 AK 200 S Operator’s manual - Major changes Program version 8.xx
Chapter 5
The chapter has been rewritten based on, and with referrals to, chapter
4. A glossary of single needle parameters and key terms has been added,
as well as instructions on how to perform single needle/single pump
treatment with pressure-controlled arterial and venous phases.
Chapter 11
There is information included about the possibility for the machine to
carry out a distribution volume calculation, displayed in litres, using the
Watson formula. See "The second screen", "Distribution volume" and
"Distribution volume calculation using the Watson formula".
Chapter 12
Changes have been made in the "Schedule for hygiene and maintenance".
"Disinfection history" has been updated, as it is now possible for the
machine to display the 50 most recently performed disinfection programs.
Chapter 14
The additional information to the attention alarm;
EXTRA PRIMING VOLUME ACHIEVED, has been updated
as the buzzer now can be muted when the blood pump is not running
until the blood pump is started again.
Program version 8.xx AK 200 S Operator’s manual - Major changes 15:3
15:4 AK 200 S Operator’s manual - Major changes Program version 8.xx
Chapter 16
Index
Program version 8.xx AK 200 S Operator’s manual - Index 16:1
A attaching . . . . . . . . . . . . . . . . . . 4:11
Acetate button . . . . . . . . . . . . . . . . 3:5 list of blood lines . . . . . . . . . . . . 1:14
Air detector . . . . . . . . . . . . . . . . . 4:16 venous blood line . . . . . . . . 4:16, 5:5
air detector head . . . . . . . . . . . . . 2:2 Blood monitor . . . . . . . . . . . . . . . . 2:2
Air gap . . . . . . . . . . . . . . . . . . . . . . 2:9 Blood path . . . . . . . . . . . . . . . . . . 3:10
Alarm . . . . . . . . . . . . . . . . . . . . . . 3:17 Blood pressure measurement
air detector . . . . . . . . . . . . . . . . 3:17 accessories . . . . . . . . . . . . . . . . 1:15
alarm indicators . . . . . . . . . . . . 3:17 cuff holder . . . . . . . . . . . . . . . . . 2:9
alarm list . . . . . . . . . . . . . . . . . . 14:2 Blood pump . . . . . . . . . . . . . . . . . 4:12
arterial pressure . . . . . . . . . . . . . 3:18 arterial blood pump . . . . . . . . . . . 2:2
attention . . . . . . . . . . . . . . . . . . 3:17 blood pump button . . . . . . . . . . 3:22
attention alarm list . . . . . . . . . . 14:9 change of segment . . . . . . . . . . 3:42
blood flow rate . . . . . . . . . . . . . 3:18 emergency stop . . . . . . . . . . . . . 3:22
blood leak . . . . . . . . . . . . . . . . . 3:17 maintenance
BPM attention . . . . . . . . . . . . . 3:19 how to clean and disinfect the
BVS . . . . . . . . . . . . . . . . . . . . . 3:17 rotor . . . . . . . . . . . . . . . . . 12:33
conductivitiy . . . . . . . . . . . . . . . 3:18 how to remove and attach the
Diascan attention . . . . . . . . . . . 3:19 rotor . . . . . . . . . . . . . . . . . 12:33
pH . . . . . . . . . . . . . . . . . . . . . . 3:17 rotor . . . . . . . . . . . . . . . . . . . . 12:33
technical . . . . . . . . . . . . . . . . . . 3:17 venous blood pump . . . . . . . 2:3, 5:5
technical alarm list . . . . . . . . . . 14:45 Bolus infusion . . . . . . . . . . . . . . . . . 8:8
temperature . . . . . . . . . . . . . . . 3:18 BPM
time attention . . . . . . . . . . . . . . 3:19 BPM button . . . . . . . . . . . . . . . 10:5
transmembrane pressure . . . . . . 3:18 BPM connection . . . . . . . . . . 2:6, 2:8
UF volume . . . . . . . . . . . . . . . . 3:18 BPM cuff
venous pressure . . . . . . . . . . . . 3:18 how to maintain . . . . . . . . . 12:34
Arrow buttons . . . . . . . . . . . . . . . 3:23 technical data . . . . . . . . . . . . . . 13:3
Arrows symbol . . . . . . . . . . . . . . 11:14 BVS . . . . . . . . . . . . . . . . . . . . 2:2, 4:12
Arterial blood line . . . . . . . . . . 4:12, 5:4 graph combinations . . . . . . . . . . . 9:5
Arterial blood pump . . . . . . . . . . . . 2:2 technical data . . . . . . . . . . . . . . 13:3
Arterial expansion chamber . . . . . . . 5:4 Bypass path . . . . . . . . . . . . . . . . . 3:10
Arterial line
arterial line clamp . . . . . . . . . . . 4:12 C
arterial line guide . . . . . . . . . 2:3, 4:12 Caution . . . . . . . . . . . . . . . . . . . . . 1:4
Arterial pressure transducer CE-marking . . . . . . . . . . . . . . . . . 1:18
connector . . . . . . . . . . . . . . . 2:2, 4:12 Central chemical disinfection . . . . 12:24
Automatic heat button . . . . . . . . . . 3:4 how to perform . . . . . . . . . . . . 12:24
Automatic rinse button . . . . . . . . . . 3:4 Charging indicator . . . . . . . . . . . 2:7, 2:9
Chemical disinfection button . . . . . . 3:4
B Chemical disinfection program
Bargraph display . . . . . . . . . .. . . . 3:10 how to perform . . . . . . . . . . . . 12:20
viewing angle adjustment . .. . . . 3:10 Clamps
Battery back-up . . . . . . . . . . .. . . . 3:38 arterial line clamp . . . . . . . . 2:3, 4:12
technical data . . . . . . . . . .. . . 13:12 infusion line clamps . . . . . . . . . . . 8:4
Bicarbonate button . . . . . . . .. . . . . 3:5 venous line clamp . . . . . . . . 2:3, 4:16
BiCart Clearance measurement . . . . . . . . . 11:2
automatic emptying . . . . . .. . . . 4:24 Clinic automation button . . . . . . . . 3:13
change during treatment . .. . . . 3:43 Clock symbol . . . . . . . . . . . 10:6, 11:14
holder . . . . . . . . . . . . . . . .. . . . . 2:5 Concentrate stand-by mode . . . 3:5– 3:6
how to connect . . . . . . . . .. . . . . 4:8 manual activation . . . . . . . . . . . . 3:7
Blood flow knob . . . . . . . . . .. . . . 3:23 Concentrates
Blood leak detector . . . . . . . .. . . . . 2:5 connect concentrates . . . . . . . . . . 4:6
how to maintain . . . . . . . .. . . 12:33 list of concentrates . . . . . . . . . . 1:13
Blood line select concentrates . . . . . . . . . . . 4:4
arterial blood line . . . . . . . . 4:12, 5:4 Connect concentrates
AK 200 S Operator’s manual - Index Program version 8.xx
acetate concentrate . . . . . . . . . . . 4:8 Function check . . . . . . . . . . . . . . . . 4:3
acidic and liquid bicarbonate overview screen . . . . . . . . . . . . 3:26
concentrate . . . . . . . . . . . . . . . . 4:8 Fuses . . . . . . . . . . . . . . . . . . . . 2:7, 2:9
acidic concentrate and BiCart . . . 4:8
SelectCart, SelectBag and BiCart . 4:7 G
Connectors Goal flag symbol . . . . . . . .11:11– 11:12
arterial pressure transducer . 2:2, 4:12 GSS/PC connection . . . . . . . . . 2:6, 2:8
system pressure transducer . . 2:3, 5:5
venous pressure transducer . 2:2, 4:16 H
Control system . . . . . . . . . . . . . . . . 1:9 Half-time . . . . . . . . . . . . . . . . . . . . 7:2
Copyright . . . . . . . . . . . . . . . . . . . 1:18 Halt button . . . . . . . . . . . . . . . . 2:7, 2:9
HDF button . . . . . . . . . . . . . . . . . . 3:9
D Heat disinfection
Degressive graph . . . . . . . . . . . . . . 7:2 heat disinfection button . . . . . . . . 3:4
Dialysis dose measurement . . . . . . 11:2 integrated . . . . . . . . . . . . . . . . 12:17
Dialysis fluid Heat disinfection program
preparation . . . . . . . . . . . . . . . . 1:12 automatic start . . . . . . . . . . . . 12:16
preparation, technical data 13:4, 13:14 automatic switch off . . . . . . . . 12:17
Dialysis fluid filter . . . . . . . . . . . . . . 2:9 how to perform . . . . . . . . . . . . 12:11
Dialysis fluid tubes with CleanCart . . . . . . . . . . . . 12:12
dialysis fluid inlet . . . . . . . . . . . . . 2:4 with liquid citric acid . . . . . . . . 12:13
dialysis fluid outlet . . . . . . . . . . . . 2:4 with WRO 300 H
Dialyzer . . . . . . . 1:14, 4:11– 4:12, 4:16 Low Flow Heat . . . . . . . . . . 12:14
attaching . . . . . . . . . . . . . . . . . . 4:11 Heating vessel overflow . . . . . . . 2:7, 2:9
dialyzer holder arm . . . . . . . . . . . 2:4 Heparin
dialyzer path . . . . . . . . . . . . . . . 3:10 heparin button . . . . . . . . . . . . . . 3:9
Dialyzer path . . . . . . . . . . . . . . . . 3:10 heparinization . . . . . . . . . . . . 4:13
Diascan heparin pump . . . . . . . . . . . . . . . 2:3
key terms . . . . . . . . . . . . . . . . . 11:3 attaching syringe . . . . . . . . . . 4:14
parameters . . . . . . . . . . . . . . . . 11:3 set values . . . . . . . . . . . . . . . . . 4:15
precautions . . . . . . . . . . . . . . . . 11:4 Hold button . . . . . . . . . . . . . . . . . 3:23
technical data . . . . . . . . . . . . . . 13:6 Hygiene and maintenance schedule 12:6
Disinfection ports . . . . . . . . . . . . . . 2:4
Drain air gap . . . . . . . . . . . . . . . . . . 2:9 I
Drain outlet Information display . . . . . . . . . . . . 3:23
from the machine . . . . . . . . . 2:7, 2:9 Infusion
Dwell time . . . . . . . . . . . . . . . . . 12:18 infusion bags . . . . . . . . . . . . . . . . 8:4
infusion fluid . . . . . . . . . . . . . . . 1:15
E infusion line . . . . . . . . . . . . . . . . 8:4
Electromagnetic environment . . . 13:18 clamps . . . . . . . . . . . . . . . . . . 8:4
Expansion chamber . . . . . . .. . . . . 8:4 infusion pole . . . . . . . . . . . 2:10, 2:12
arterial expansion chamber . . . . . 5:4 height adjustment . . . . . 2:10, 2:12
holder . . . . . . . . . . . . . . . .. . . . . 2:3 infusion pump . . . . . . . . . . . 2:3, 8:4
venous expansion chamber . . . . . 5:5 Inlet water
quality . . . . . . . . . . . . . . . .. .. . 13:9
F requirements . . . . . . . . . . .. .. . 1:12
Flow diagram . . . . . . . . . . . . . . . . 3:10 Integrated Heat disinfection .. .. 12:17
Flow path Intended use . . . . . . . . . . . . .. .. . . 1:8
cleaning . . . . . . . . . . . . . . . . . 12:30 Isolated UF . . . . . . . . . . . . . .. .. . . 6:1
decalcification . . . . . . . . . . . . . 12:30 isolated UF button . . . . . .. .. . . 3:5
maintenance . . . . . . . . . . . . . . 12:30
Fluid bypass button . . . . . . . . . . . . 3:22 K
Fluid flow button . . . . . . . . . . . . . . 3:9 Kt/V button . . . . . . . . . . . . . . . . . 11:5
Fluid monitor . . . . . . . . . . . . . . . . . 2:4 Kt/V target supervision . . . . . . . . 11:2
Formaldehyde . . . . . . . . . . . . . . . 12:19
Program version 8.xx AK 200 S Operator’s manual - Index
L arterial pressure . . . . . . . . . . . . . 3:31
Latch for filter change . . . . . . . . . . . 2:9 blood flow . . . . . . . . . . . . . . . . 3:30
Level adjustment buttons . . . . . . . . 2:3 blood pump segment . . . . . . . . . 3:30
Linear graph . . . . . . . . . . . . . . . . . . 7:2 BPM, BVS, Diascan . . . . . . . . . 3:31
Lines . . . . . . . . . . . . . . . . . . . . . . 1:14 conductivity . . . . . . . . . . 3:30– 3:31
arterial blood line . . . . . . . . 4:12, 5:4 dialysis fluid flow . . . . . . . . . . . . 3:31
venous blood line . . . . . . . . 4:16, 5:5 heparin . . . . . . . . . . . . . . . . . . . 3:31
Low Flow Heat . . . . . . . . . 12:14, 14:33 SN data . . . . . . . . . . . . . . . . . . 3:30
temperature . . . . . . . . . . . . . . . 3:30
M time . . . . . . . . . . . . . . . . . . . . . 3:31
Machine TMP . . . . . . . . . . . . . . . . . . . . . 3:31
blood monitor . . . . . . . . . . . . . . . 2:2 UF rate . . . . . . . . . . . . . . . . . . . 3:31
BM 200 and BM 202 . . . . . . . . 2:2 UF volume . . . . . . . . . . . . . . . . 3:31
fluid monitor . . . . . . . . . . . . . . . . 2:4 venous pressure . . . . . . . . . . . . 3:30
FM 202 . . . . . . . . . . . . . . . . . . 2:4 Per-Low . . . . . . . . . . . . . . . . . . . 12:20
physical data . . . . . . . . . . . . . . 13:16 Peracetic acid . . . . . . . . . . . . . . . 12:19
power supply . . . . . . . . . . . . . 13:10 Physical data of the machine . . . . 13:16
rear of the machine Pick-up tube
options included . . . . . . . . . . . 2:8 A pick-up tube . . . . . . . . . . . . . . 2:4
without options . . . . . . . . . . . . 2:6 B pick-up tube . . . . . . . . . . . . . . 2:4
transportation and storage . . . . 13:18 Potential equalization . . . . . . . . . . . 1:6
Main switch . . . . . . . . . . . . . . . 2:7, 2:9 Potential equalization connection . . 2:6,
Mains supply inlet . . . . . . . . . . . 2:7, 2:9 2:8
Maintenance Power failure
blood leak detector . . . . . . . . . 12:33 recovery . . . . . . . . . . . . . . . . . . 3:39
blood pump . . . . . . . . . . . . . . 12:33 returning the blood . . . . . . . . . . 3:38
BPM cuff . . . . . . . . . . . . . . . . 12:34 Power supply unit . . . . . . . . . . . 2:7, 2:9
exterior . . . . . . . . . . . . . . . . . . 12:33 Precautions . . . . . . . . . . . . . . . . . . . 1:5
top tray . . . . . . . . . . . . . . . . . . 12:33 Preparation of dialysis fluid . . . . . . 1:12
Manufacturer . . . . . . . . . . . . . . . . 1:18 Preset
Monitor stand can be preset . . . . . . . . . . . . . . . . 1:4
bars, lifting positions . . . . . 2:10, 2:12 Priming
height control . . . . . . . . . . . . . . 2:13 in double needle mode, finishing
power supply cord . . . . . . . . . . . 2:13 in single needle/double pump
rear handle . . . . . . . . . . . . 2:10, 2:12 mode . . . . . . . . . . . . . . . . . . . . 5:6
screws . . . . . . . . . . . . . . . 2:11– 2:12 in HDF low volume . . . . . . . . . . 8:6
Mute button . . . . . . . . . . . . . . . . . 3:22 in single needle/double pump
mode . . . . . . . . . . . . . . . . . . . . 5:9
N priming button . . . . . . . . . . . . . . 3:9
Note . . . . . . . . . . . . . . . . . . . . . . . . 1:4 priming detector . . . . . . . . . . . . . 2:3
Profiling
O activation . . . . . . . . . . . . . . . . . . 7:7
degressive graph . . . . . . . . . . . . . 7:2
ON/OFF button . . . . . . . . .. . . . . 3:4
half-time . . . . . . . . . . . . . . . . . . . 7:2
Operator’s panel . . . . . . . . . .. . 2:3, 3:3
linear graph . . . . . . . . . . . . . . . . . 7:2
Optional connection . . . . . . .. . 2:7, 2:9
profiling button . . . . . . . . . . . . . . 3:9
Override . . . . . . . . . . . . . . . .. . . . 3:20
progressive graph . . . . . . . . . . . . 7:2
air detector alarm . . . . . . .. . . . 3:20
technical data . . . . . . . . . . . . . . 13:5
arterial pressure alarm . . . .. . . . 3:20
UF rate . . . . . . . . . . . . . . . . . . . . 7:4
blood leak alarm . . . . . . . .. . . . 3:21
Progressive graph . . . . . . . . . . . . . . 7:2
low venous pressure alarm .. . . . 3:20
Protective system . . . . . . . . . . . . . . 1:9
P for low volume HDF . . . . . . . . . . 8:2
for ultrafiltration . . . . . . . . . . . . 3:35
Parameter buttons . . . . . . . . . . . . . 3:12
Pulse rate symbol . . . . . . . . 10:6– 10:7
Parameter settings
AK 200 S Operator’s manual - Index Program version 8.xx
R System pressure transducer
Rear of the machine connector . . . . . . . . . . . . . . . . 2:3, 5:5
options included . . . . . . . . . . . . . 2:8 System pressure transducer protector 8:4
without options . . . . . . . . . . . . . . 2:6
Recirculation . . . . . . . . . . . . . . . . . 3:40 T
Relay interface connection . . . . . 2:6, 2:8 Time display . . . . . . . . . . . . . . . . . 3:11
Reset . . . . . . . . . . . . . . . . . . . . . . 3:16 Time to target symbol . . . . . . . . . 11:14
Residual test . . . . . . . . . . . . . . . . 12:23 Top tray . . . . . . . . . . . . . . . . . . . . . 2:2
Rinse/Drain button . . . . . . . . . . . . 3:4 how to maintain . . . . . . . . . . . 12:33
Rinse/Drain program . . . . . . . . . 12:25 Tray for concentrate containers . . .2:11,
automatic start . . . . . . . . . . . . 12:28 2:13
automatic switch off . . . . . . . . 12:29 Treatment overview screen . . . . . . 3:24
with CleanCart . . 12:17, 12:26, 12:29 Treatment parameters
download . . . . . . . . . . . . . . . . . 3:32
S
Safety coupling . . . . . . . . . . . . . . . . 2:4 U
Safety philosophy . . . . . . . . . . . . . . 1:9 UF calibration unit connection . 2:7, 2:9
SelectBag UF rate profiling . . . . . . . . . . . . . . . 7:4
automatic emptying . . . . . . . . . . 4:24 Ultrafiltered Dialysis Fluid . . . . . . . 1:12
holder . . . . . . . . . . . . . . . . . . . . . 2:5 Ultrafilters
how to connect . . . . . . . . . . . . . . 4:7 frequency of change . . . . . . . . . 1:12
SelectCart ultrafilter . . . . . . . . . . . . . . . . . . 1:14
automatic emptying . . . . . . . . . . 4:24 how to change . . . . . . . . . . . 12:31
change during treatment . . . . . . 3:43 Ultrafiltration
holder . . . . . . . . . . . . . . . . . . . . . 2:5 control . . . . . . . . . . . . . . . . .. . 3:34
how to connect . . . . . . . . . . . . . . 4:7 control, technical data . . . . . .. . 13:5
Set knob . . . . . . . . . . . . . . . . . . . . 3:23 technical data . . . . . . . . . . . .. 13:15
Single needle ultrafiltration path . . . . . . . . .. . 3:10
parameters and key terms . . . . . . 5:3
Single needle button . . . . . . . . . . . . 3:5 V
Smiley symbol . . . . . . . . . . . . . . . 11:14 Venous blood line . . . . . . . . . . 4:16, 5:5
Sodium hypochlorite . . . . . . . . . . 12:19 Venous blood pump . . . . . . . . . 2:3, 5:5
Standards . . . . . . . . . . . . . . . . . . 13:22 Venous expansion chamber . . . . . . . 5:5
Start UF Stop button . . . . . . . . . . . 3:22 Venous line clamp . . . . . . . . . . 2:3, 4:16
Substitution fluid . . . . . . . . 13:5, 13:15 Venous pressure transducer
Symbols connector . . . . . . . . . . . . . . . 2:2, 4:16
arrows symbol . . . . . . . . . . . . . 11:14 Volume control button . . . . . . . . . . 3:5
clock symbol . . . . . . . . . . 10:6, 11:14
goal flag symbol . . . . . .11:11– 11:12 W
list of symbols . . . . . . . . . . . . . . 1:16 Warning . . . . . ... . . . . . . . . . . . . . 1:4
pulse rate symbol . . . . . . 10:6– 10:7 Water inlet . . . ... . . . . . . . . . . 2:7, 2:9
screen symbols, disinfection . . . . 12:4 Watson formula .. . . . . . . . . . . . . 11:9
smiley symbol . . . . . . . . . . . . . 11:14 Wheels, lockable .. . . . . . . . . 2:11, 2:13
time to target symbol . . . . . . . . 11:14
Program version 8.xx AK 200 S Operator’s manual - Index
~ CANDELA CORPORATION PROPRIETARY ~
MiniGL
FIRMWARE REQUIREMENT SPECIFICATION
May 29, 2003
CANDELA CORPORATION
530 BOSTON POST ROAD
WAYLAND, MASSACHUSETTS 01778-1883
1010-06-3020 Revision B2 Page 1 of 14

1 PURPOSE....................................................................................................................................................................................3
2 DEFINITIONS .............................................................................................................................................................................3
3 REFERENCES .............................................................................................................................................................................3
4 PRODUCT DESCRIPTION......................................................................................................................................................3
4.1 PRODUCT CONCEPT ..................................................................................................................................................3
4.1.1 Mini-GL..................................................................................................................................................................3
4.1.2 Mini-GL (LE)..........................................................................................................................................................3
4.1.3 Both Systems ..........................................................................................................................................................4
4.2 CONTROL SYSTEM FIRMWARE.............................................................................................................................4
4.3 CONSTRAINTS ............................................................................................................................................................4
4.3.1 Hardware.................................................................................................................................................................4
4.3.2 Programming Language ............................................................................................................................................5
4.3.3 Safety ......................................................................................................................................................................5
4.4 ASSUMPTIONS AND DEPENDENCIES ..................................................................................................................5
5 DETAILED REQUIREMENTS ..................................................................................................................................................5
5.1 SYSTEM STATES ........................................................................................................................................................5
5.1.1 Initialization State...................................................................................................................................................7
5.1.2 Standby State..........................................................................................................................................................7
5.1.3 Ready State.............................................................................................................................................................7
5.1.4 Fault State...............................................................................................................................................................8
5.2 USER INTERFACE .......................................................................................................................................................10
5.2.1 Operator Controls ...................................................................................................................................................10
5.2.2 Displayed Control Variables ...................................................................................................................................11
5.3 DCD CONTROL (OPTIONAL)....................................................................................................................................12
5.3.1 No DCD Connected (no treatment area cooling) ....................................................................................................12
5.3.2 Internal DCD (Candela 1000g Canister) Connected ...............................................................................................12
5.3.3 External DCD (External Large Cylinder) Connected...............................................................................................12
5.3.4 Third Party Vendor Cooling....................................................................................................................................12
5.4 DI TEMPERATURE CONTROL.................................................................................................................................13
5.5 SYSTEM SAFETY MONITOR COMPONENTS ......................................................................................................13
5.6 SYSTEM MAINTENANCE INTERFACE .................................................................................................................13
5.6.1 Laser Variable Mode ...............................................................................................................................................13
5.6.2 Maintenance Mode (MM or Maint Mode)............................................................................................................13
6 FAULTS AND WARNINGS .....................................................................................................................................................14

1 PURPOSE
The purpose of this document is to define the requirements of the firmware for the Mini-GL and LE laser systems. The firmware
for these lasers will be designed to deliver and calibrate the selected fluence settings, control system functions, and provide
user interface functions. The firmware will be used to control internal parameters, monitor and maintain operation variables.
The intended audience for this document includes the following:

• Marketing
• Engineering
• Regulatory Affairs
• Clinical Research
• Quality Assurance
• Field Service
• Manufacturing
2 DEFINITIONS
The following are definitions of terms and acronyms used in this document:
A/D: Analog-to-Digital Converter LCD: Liquid-Crystal Display

CDRH: Center for Devices and Radiological Health LVM: Laser Variable Mode (User access to Service
CP: Cal Port Energy Information)
CPU: Central Processing Unit (Microprocessor) MM: Maintenance Mode (Service Tech access to in-
D/A: Digital-to-Analog Converter depth System Control)
DCD: Dynamic Cooling Device RAM: Random Access Memory
DI: De-Ionized Water ROM: Read Only Memory
EOC: End of Charge TSDP: Touch Screen Display Panel (LCD display with
HD: Head Energy touch panel overlay)
HVPS: High Voltage Power Supply UI: User Interface
HP: Handpiece xHD: Expected Head Energy
I/O: Input/Output
3 REFERENCES
The following reference documents were used in the development of this requirement:
• 8502-30-0010 CANDELA Firmware Standard Operating Procedure (FSOP)
• 9914-90-0880 Mini-GL Engineering Design Specification
• 9914-92-0880 Mini-GL System Requirement Specification
• 9914-84-0880 Mini-GL Functional Block Diagram
4 PRODUCT DESCRIPTION
4.1 PRODUCT CONCEPT
4.1.1 MINI-GL
The MiniGL laser is a pulsed, flash lamp excited medical laser, controlled by an embedded microprocessor (or CPU), to be
used for the removal of vascular lesions that absorb strongly at the 755nm wavelength. The Mini-GL laser delivers the
energy using one of six delivery systems: 1) A DCD enabled HP with a 6mm/8mm/10mm slider, 2) A non-DCD version with
the same slider, 3) A DCD enabled HP with a 12mm/15mm/18mm slider, and 4) A non-DCD version with this same slider, 5) A
DCD enabled HP with a 12mm slider, and 6) A non-DCD version with this same slider.
4.1.2 MINI-GL (LE)
The MiniGL (LE) uses exactly the same firmware. The differences from the Mini-GL are slight. The LE only supports two
delivery systems: 1) A DCD enabled HP with a 12mm slider, and 2) A non-DCD version with this same slider. The HVPS is
modified to only allow repetition rates of 1Hz, The laser-type selection is accomplished by entering a different model number
in MM.

4.1.3 BOTH SYSTEMS

The system is comprised of a HVPS, flash lamp, laser head, and associated optics to direct the laser beam into a fiber
delivery system for accurate control of the laser beam spot size. An embedded 68HC12 micro-controller is used to control
the laser components, display and touch screen, and control electronics to deliver proper treatment energy.
The system’s User Interface is achieved through the use of an LCD display, and a resistive touch screen overlay integrated
into the display. Graphical buttons are displayed on the LCD display to allow for flexible control. The UI allows the operator
to select treatment energies, set optional parameters, and control operational states of the system.
An optional Dynamic Cooling Device (DCD) is available with the Mini-GL system to provide cooling to the epidermis prior
to each laser pulse. The firmware regulates the cryogen pressure, maintains a remaining spray count, and delivers cryogen.
The laser has the ability to calibrate the output energy of the delivery system to the fluence level selected by the operator.
Once the energy has been calibrated, the laser can deliver a single pulse or deliver continuous pulses at a rate of 1.5Hz
(MGL) or 1.0Hz (MGL-LE), while the trigger switch is engaged.
Lasing is accomplished by discharging the charged Pulse Forming Network (PFN) into the flash lamp thereby exciting the
lasing material. Through a calibration process, the firmware calculates the charge voltage necessary to establish a
relationship between the applied PFN voltage and the delivered energy. During treatment pulses, the system monitors the
HV charging process, and measures the energy of each pulse.
4.2 CONTROL SYSTEM FIRMWARE

The system firmware will be designed to accomplish the following tasks:
• Initialization of all hardware into a known safe state at power-on. (see section 5.1.1)
• Verification of memory: ROM & Battery Backed RAM (see section 5.1.1).
• Verification of hardware diagnostic (see section 5.1.1).
• Control all system states & processes (Italic) (see section 5.1):
o STANDBY
§ WARMUP
o READY
§ CALIBRATE
§ ACTIVATE
o FAULT
• Maintain a User Interface (UI) via a control panel located on the laser façade. The UI will allow the operator to select
the user adjustable parameters of the system. The interface will also be used to convey faults, warnings, and system
status to the user (see section 5.2).
• Control DCD pressure and DI temperature critical to system operation (see sections 5.3, 5.4).
• Calibrate and monitor laser energy when the system is pulsing
• Monitor and control capacitor charge and charging state.
• Control and monitor system safety interlock components when in a READY state (see section 5.5)
• Provide a Laser Variable Mode display screen. This screen provides read-only information as to system status.
• Provide Service Mode (formerly Maintenance Mode) display screens. Service Mode will allows users (service
personnel and in-house personnel) to monitor, control, and change values normally maintained by system software
(see section 5.6).
• Handle all controllable conditions where the system is not operating within “specified” parameters (see section 6).
4.3 CONSTRAINTS
The following constraints shall be imposed on the firmware design:
4.3.1 HARDWARE
• The system µP will operate at 8-MHz.
• The firmware program will be programmed at CANDELA onto a 512K EPROM or FLASH memory device. Note that
the board only supports the upper 256 Kbytes of program memory (ROM).
• The maximum amount of external memory (RAM) available shall be 32 Kbytes (non-volatile). This external memory
will be partitioned to hold non-volatile variables, temporary variables, and stack information in separated regions of
memory.

• Battery backed system parameters and calibration data used by the firmware shall be stored in the non-volatile sector
of RAM and will be checked at each power-up.
• A hardware interlock prevents laser operation if the remote CDRH interlock is not inserted.
4.3.2 PROGRAMMING LANGUAGE
• The firmware program shall be written in the C language, using assembly language only where absolutely necessary,
to allow for easier firmware maintenance.
• The firmware program will be compiled, assembled, and linked using Cosmic Software’s C Cross Compiler for
Motorola MC68HC12.
4.3.3 SAFETY
• The system shall always power-up in a system-safe state and revert to a system-safe state when the laser faults.
• The firmware prevents laser output while the trigger switch is not being depressed.
• Non-volatile system parameters that are out of range at start-up will default to safe parameters when initialized by
software.
4.4 ASSUMPTIONS AND DEPENDENCIES

The following assumptions shall be used in designing the firmware:
• The embedded system is stable and data integrity is preserved while system is powered. Periodic data checks are
only required for system-critical parameters.
• All hardware is calibrated to provide the micro-controller with correct input voltages where applicable.
• The operator will use the system in a manner consistent with intended use and comply with direction displayed by
the UI and the instruction manual.
• Depressing the trigger switch will be the only method for software to trigger the laser.
5 DETAILED REQUIREMENTS
5.1 SYSTEM STATES
The laser system shall have 3 States: STANDBY, READY, & FAULT. A detailed state chart describing the interaction of
the three states and state sub-processes is provided in Figure 1.
1) After the system is powered on and initialized the laser will enter STANDBY state.
2) The laser must be placed in the ready state in order to pulse the laser.
3) Any exceptions to normal system operation parameters will put the laser in the FAULT state.
4) Program execution will always flow through the main loop regardless of state. Background functions and main loop
modules will periodically monitor and control system operation.

Mini-GL State Diagram
INITIAL
System Initialized
Checksum OK
ROM CheckSum
Failure
Warmup
WARMUP
Timeout
Non-Recoverable Fault
System Requires
FAULT
Service
Warm-up
Required Fault Cleared
CALIBRATION ACTIVATE
Cal Complete Pulse

Completed
Warm-up
Complete
Calibration Required Calibration Not Required

& trigger pressed & Trigger pressed
Process = CAL
STANDBY Ready, CAL Pressed READY

Ready State Timeout or
Standby Pressed
Figure 1 – Mini-GL State Diagram

5.1.1 INITIALIZATION STATE

When the system is powered on, the firmware shall execute the following:
1) System Power On Initialization
o All system hardware will be reset to a known non-lasing state via the firmware.
2) Firmware/Data Diagnostics:
o Checksum verification of Read Only Memory is performed. If the calculated value does not equal the stored
value, a fault will be indicated.
o RAM Validity Tests:
3) Check that the software version has not changed from previously stored value. Used as an indication that memory
was corrupted or the ROM has been changed. All non-volatile data except Pulse counts and the canister weight are
set to a default value if ROM has changed.
4) Check that critical variables are within bounds. If not, then set to default values.
5) Perform a diagnostic of hardware
o System will determine if external DCD unit is attached.
o System will verify the DI fluid pump and pressure sensor are operational.
o System will determine the delivery system connected to the system at all times.
6) Set initial system state to STANDBY.
7) Set Calibration Required – Clear CAL table (forces a Full CAL).
8) Keep UI parameters (Fluence, DCD…) same as previous power-up. If outside range, set to nominal parameters. – No
messages are displayed that these changed.
9) Display the Candela Logo along with the firmware P/N and revision.
5.1.2 STANDBY STATE
The firmware shall perform as follows when entering the STANDBY state:
1) Set the laser to the STANDBY state.
2) Indicate the system state as “STANDBY” via the UI.
3) Ensure laser is disabled, and lasing is off.
4) Ensure the laser is in a non-charging state.
5) Ensure the Aiming Beam is off.
5.1.2.1 Standby Sub-process
The firmware shall perform the following while the STANDBY process is executing:
1) Set the Calibration Required if the calibration timer has expired (30minutes), or delivery system is disconnected, or the
HP slider position has been changed.
2) Verify Laser Shutter is closed.
3) Verify HV reference is set to a zero value.
4) Allow entry into LVM or MM.
5.1.2.2 Warm-up Sub-process
The firmware shall perform the following while the WARMUP process is executing:
1) DI water temperature and (if connected) cryogen pressure will be monitored periodically.
2) A Warm-up status percentage bar is set according to the following:
- Calculate %Complete of DI temperature from nominal ambient temperature to operating temperature.
- Calculate %Complete of DCD Pressure (if connected) from nominal ambient pressure to operating pressure.
- Display %Complete of the lowest percentage on the UI.
3) Warm-up will complete when both DI temperature and DCD Pressure have come within the proper range.
4) Allow entry into LVM or MM.
5) Upon completion of WARMUP the unit reverts to the STANDBY process.
5.1.3 READY STATE
The firmware shall perform as follows when entering the READY state:
1) Set the laser to the READY state.
2) Indicate the system state as “READY” via the UI.

3) Set aiming beam ON. The user can set the aiming beam intensity to 3 different settings. The beam must always be
visible while in Ready to meet “remote Ready Indicator” safety condition.
4) Prevent entry if the trigger switch is pressed, and display a warning message until trigger switch is released.
5) Do a Bubble Circuit test on HP and Canister sensors (DCD enabled). If there are no bubbles during test – then fault.
6) As a safety precaution, delay 2 seconds after Ready Lamp and Aiming Beam (remote Ready indicator) ON, before
enabling the HVPS.
o HVPS only enabled if calibration is not required and valid charge voltage is set.
5.1.3.1 Ready Sub-processes
The firmware shall perform the following while in the READY sub-process:
1) Initiate HV charge sequence prior to each laser pulse.
2) Monitor pulse timer to deliver pulses at a rate of up to 1.5 Hz when the trigger switch is continuously depressed.
3) Determine when conditions have been met to pulse.
§ Rep Rate Timer has expired
§ HV Charged
§ Trigger is pressed
4) Shutter is open while in Ready to allow Aiming Beam to be seen.
5) As a safety precaution, if the laser is in the READY and laser output has not been generated within the last 2
minutes, the system will automatically return to the STANDBY State. (READY state timeout).
6) When a valid trigger source is detected the ACTIVATE process or CALIBRATION process will be executed based
on the cal required flag status.
7) MAIN screen is the only screen available while pulsing. This is so that Fluence, and other parameters are present
while pulsing.
8) When using a long PreSpray and Delay time, the laser can start spraying prior to the HV charge attains the EOC to
allow the laser to run at it’s fastest rep rate.
5.1.3.2 Calibrate Sub-processes
The firmware shall perform the following while the CALIBRATION process is executing:
1) Display a spot size confirm message on entry into CAL. This should not be shown on the LE model.
2) Prompt the user to place the handpiece in the CAL PORT and depress the trigger switch.
3) Initialize calibration variables.
4) Calculate initial HVPS voltage from the selected fluence and fluence vs. Voltage curve.
5) With the trigger switch depressed, pulse laser into CAL PORT and adjust voltage to achieve desired fluence.
6) On completion of a CAL, when the user removes the handpiece from the Cal Port, the system will automatically revert
back to Standby to allow the user to install a dis tance gauge. The handpiece MUST be removed at the end of the
calibration to clear the CAL required status. If the Standby button is pressed at the end of the CAL, the CAL required
status would not be cleared. This is done to ensure the cal port switch is tested for a state change. Note that the
footswitch and fingerswitch will both meet these criteria.
7) Force the system to Standby if a required user action has not been performed in a short time period (15 seconds – 1
minute).
5.1.3.3 Activate Sub-processes
The firmware shall perform the following while executing the ACTIVATE process when the trigger is activated:
1) Start the DCD/Lasing sequence.
2) Measure laser energy output and verify system operation is within limits.
3) Update system and treatment pulse counters as necessary.
4) Display a Lasing icon.
5.1.4 FAULT STATE
The firmware shall perform as follows when in the FAULT state:
1) Set the laser to the fault state.
2) Inform the user of fault condition via UI.
3) Return the laser to a non-lasing state to prevent personal injury or damage to the laser.
4) System disallows further emission until the user corrects the problem (if possible) and clears the fault via the UI.
5) Set required flags (CAL or Warmup required) required by a fault when system cleared from the fault state. See
individual fault list.

6) When a fault condition is cleared the system will enter the STANDBY state.
7) If the system is in maintenance mode, faults will be not be serviced, and the system will continue running.

5.2 USER INTERFACE

5.2.1 OPERATOR CONTROLS
The firmware shall acquire operator input by monitoring the control panel touch screen.

5.2.1.1 Control Buttons

The following display buttons are in the “Control” section (upper and lower portion) of the UI.
1) Standby - Places the system in STANDBY state.
2) Ready - Places the system in READY state.
3) Calibrate - Causes the system to begin energy calibration.
4) Purge - Purges the DCD cryogen lines of air/gas. Also displays the currently selected spot size. If the DCD is not
enabled, a “handpiece” icon will be displayed in the lower Control section (instead of the purge button.) This
displays the active spot-size. If the spot size is unknown, it will display “---". When the slider position is changed,
and the Fluence is outside the range for this new spot-size, it is set to the lowest.
5) Next - Selects the next screen (Main or Options screen).
5.2.1.2 Main Screen Parameter Buttons
The following display buttons are in the ‘Parameter” section (mid section) of the Main screen.
1) Fluence Select - Selects the fluence parameter. The Up/Down Adjust buttons are used to adjust the fluence in 1, 2 or
5J increments based on the spot size and displayed fluence. (Spot size is limited to 12mm only for the LE version.)
2) Rep Rate Select - Selects the Laser pulse repetition rate. The Up/Down Adjust buttons can select Single (0Hz), 0.5Hz,
1.0Hz, or 1.5Hz. (Rep Rate maximum is 1.0Hz for the LE version.)
3) DCD Pre-Spray Select - Selects the cryogen spray timing (if DCD connected) prior to lasing. The Up/Down Adjust
buttons are used to adjust the time to 0, and 20-100 in 10 ms increments. If the spot size is changed to 15mm or 18mm,
the pre-spray will default to 30ms or 40ms, respectively, if below these values. This default will occur at power-up as
well.
4) DCD Delay Select - Selects the delay between first cryogen spray and lasing pulse. The Up/Down Adjust buttons are
used to adjust the time to 3, 5, and 10-150 in 10ms increments.
5) DCD Post-Spray Select - Selects the cryogen spray timing (if DCD connected) after lasing completed. The Up/Down
Adjust buttons are used to adjust the time to 0, and 10-100 in 10ms increments.
6) Up/Down Adjust - Adjusts the selected parameter. If an Adjust button is held down, the selected parameter is
incremented to its limit. The increment speed also increases if held down.
7) Pulse Count Reset - Displays Patient Pulses counted. Pressing the button for 2 seconds resets the counter.
8) Canister Pulses Reset - Displays the remaining DCD cryogen pulses. Pressing the button for 2 seconds resets the
canister pulses to indicate a full canister for the current spray selections.
5.2.1.3 Option Screen Parameter Buttons
The following display buttons are in the ‘Parameter” section (mid section) of the Options screen.
1) Language Select - Selects the Language parameter. The Up/Down Adjust buttons are used to select the language
used to display all messages.
2) Trigger Switch Select - Selects the Trigger switch. The Up/Down Adjust buttons are used to select Footswitch or
Fingerswitch.
3) Aiming Beam - Selects the Aiming Beam Intensity. The Up/Down Adjust buttons are used to select three different
intensities.
5.2.2 DISPLAYED CONTROL VARIABLES
The following information will be provided via the control panel:
1) Laser Status (READY or STANDBY).
2) Fluence setting.
3) Repetition Rate setting.
4) DCD Pre-Spray timing.
5) DCD Delay timing.
6) DCD Post-Spray timing.
7) DCD pulses remaining.
8) Patient Pulses (Reset by user).

5.3 DCD CONTROL (OPTIONAL)

The DCD spray sequence is defined as a PreSpray time (from TSDP), a Delay Time (from TSDP), a fixed spray time, the 1st
fixed delay, and then the laser pulses. After the laser pulse, the DCD spray sequence continues with a 2nd fixed delay, and the
PostSpray time (from TSDP).
§ Pre-Spray time [TSDP PreSpray time in ms] – 5ms (accommodates the Fixed Spray Time)
§ Delay time [TSDP Delay time in ms]
§ Fixed Spray time [5ms]
§ 1st Fixed Delay time [9ms]
§ Laser Pulse
§ 2nd Fixed Delay time [6ms]
§ Post-Spray time [TSDP PostSpray time in ms]
The following tolerance requirements are for the above time segments:
Time segment < 50ms +-2ms
Time segment >= 50ms +-5%
The DCD or cryogen system is installed as an option. There are four different scenarios of cooling:
5.3.1 NO DCD CONNECTED (NO TREATMENT AREA COOLING)
1) DCD related Buttons (Purge, Pre-Spray, Delay, Post-Spray, Canister Volume) are not displayed.
2) A spot-size selected icon is displayed in place of the Purge button
3) Firmware keeps DCD Canister Heater signal Off (safe condition)
4) DCD Pressure sensor is ignored
5) DCD Bubble detects both ignored
6) Firmware pulses laser w/o any DCD time delays
7) Allow use of either DCD (no spray of course) or non-DCD delivery systems.
5.3.2 INTERNAL DCD (CANDELA 1000G CANISTER) CONNECTED
1) HP and Canister Bubble detectors are tested for proper operation on entry into Ready.
2) DCD unit is detected when changed by a dedicated control signal.
3) DCD related Buttons (Purge, Pre-Spray, Delay, Post-Spray, Canister Volume) are displayed and active.
4) Control a canister heater to maintain pressure as specified in Engineering Design Spec #9914-90-0880. A PI algorithm
is used to determine the heater duty cycle.
5) Determine if a DCD enabled delivery system is connected to the system. If not connected, don’t display buttons.
6) Monitor bubble sensors located in the handpiece and at the base of the canister. The sensors will be used to perform
the following tasks:
o Ensure bubbles are not in the cryogen line when DCD is being sprayed, and fault when bubbles present.
o Determine when the cryogen canister needs to be replaced.
7) Dispense cryogen during pulse or purge operations (for length of Pre-spray + Post-spray settings) by controlling an
electronic valve in the cryogen delivery system.
8) Allow the user to purge the cryogen delivery system.
5.3.3 EXTERNAL DCD (EXTERNAL LARGE CYLINDER) CONNECTED
1) Only HP Bubble detector is tested for proper operation on entry into Ready.
2) DCD unit is detected when changed by a second dedicated control signal.
3) DCD related Buttons (Purge, Pre-Spray, Delay, Post-Spray), except Canister Volume, are displayed and active.
4) Firmware keeps DCD Canister Heater signal Off (safe condition)
5) Determine if a DCD enabled delivery system is connected to the system. If not connected, don’t display buttons.
6) Monitor bubble sensor located only in the handpiece. The sensor will be used to perform the following tasks:
7) Ensure bubbles are not in cryogen line when DCD is being sprayed, and fault when bubbles present.
8) Dispense cryogen during pulse or purge operations (for length of Pre-spray + Post-spray settings) by controlling an
electronic valve in the cryogen delivery system.
9) Allow the user to purge the cryogen delivery system.
5.3.4 THIRD PARTY VENDOR COOLING

This option allows other cooling devices to be used. There is no synchronization provided. The Laser firmware operates
as if there is no DCD connected.
5.4 DI TEMPERATURE CONTROL

To control the DI temperature, the firmware will:
1) Maintain DI temperature to +-2degC.
2) Utilize ‘bang-bang’ control to heat DI reservoir temperature when below the set point.
3) Utilize PI control of a pulse-width modulated DC fan to maintain DI temperature when above set point.
4) Run a diagnostic at power up to ensure water pump and pressure switch operate correctly.
5) Monitor water pressure during system operation.
6) Turn DI fans on for 3 seconds every 3 minutes in Standby if they haven't been on.
5.5 SYSTEM SAFETY MONITOR COMPONENTS

To ensure operator and patient safety, the firmware will:
1) Monitor Cal Port switch to insure hand piece is in Cal Port when necessary.
2) Monitor Delivery System detection circuitry.
3) Differentiate between hand piece spot sizes and DCD and Non-DCD enabled hand pieces and enable DCD control
based on the HP.
4) Monitor removal of the delivery system fiber when in READY state.
5.6 SYSTEM MAINTENANCE INTERFACE

5.6.1 LASER VARIABLE MODE (LVM)
The firmware will allow viewing of critical system parameters in LVM. The purpose of LVM is to simplify system
diagnostics over the phone with service personnel. It provides the following:
1) Access to the LVM is accomplished by pressing the Next button for 2 seconds.
2) Display calculated Head energy at 60J parameter.
3) Provide a Touch Screen calibration button.
4) Display firmware P/N and revision.
5) Display Model and Serial # to allow customer easy access to info when talking with Tech Support.
6) Display Total Treatment Pulses (non-CAL Pulses).
7) Display pulse data consisting of: pulse #, HV, HD, CP, TX (to 2 decimal places).
8) Provide Standard Deviation, and mean of HD and CP energies. A button is provided to reset counts.
5.6.2 MAINTENANCE MODE (MM OR MAINT MODE)
The firmware will provide service with a Maintenance Mode that performs the following:
1) This mode is accessed by first, pressing an internal switch, and then entering a 4 digit access code.
2) All control of the laser is through the lasers’ UI.
3) An external PC laptop connected via an RS-232 serial port (baud rate of 9600 bps) provides the ability to output pulse
data.
4) The user cannot access this mode without opening the laser.
5) The Model # and Serial # can be entered in MM. The Mini-GL uses 0880 and 0890, and the LE uses 0910 and 930.
This will allow the firmware to detect the difference between the two lasers. The model # will be checked at each
power-up to ensure it is these values. The default value will be 9914-0880-0001.
6) Total Treatment Pulses (PP) can be modified.

6 FAULTS AND WARNINGS

The Mini-GL constantly monitors its sub-systems. The following are conditions that may interfere with ‘normal’ system
operation and will display a warning or fault message. Note the “C” and “W” indicates a CAL or Warmup is required.
-1. Mini-GL Fault Type FAULT DESCRIPTION
HP Bubble Circuit Test didn’t detect a change in the signal (with DCD-enabled HP).
1.1
1 - BUBBLE DETECT (Internal [Candela] or External Cylinder DCD system must be installed)
CIRCUIT FAULT Canister Bubble Circuit Test didn’t detect a change in the signal (with DCD-enabled HP).
1.2
(Internal [Candela] DCD system must be installed)
2 - ROM CHECKSUM 2 Calculation of checksum at power-up does not match checksum value in memory.
3 - SHUTTER FAULT 3 Shutter isn’t in correct state when checked. Does not respond to actuation to correct state.
5.1 HV sample does not settle to within +-8 volt at End of Charge (EOC) within 1.5 seconds. C
5 - HV TOLERANCE
5.2 HV sample is not within +-3% of HV reference when HVPS is at EOC. C
FAULT
5.3 HV sample is not within +-3% of HV reference after DCD pre-spray already occurred. C
6.1 CAL Low slope point not in range of 500V to 1800V. C
6.2 Expected Head Energy (xHD) is calculated > Max HD Energy of 75 J. C
6 - CALIBRATION FAULT
6.3 Laser failed to CAL to desired Fluence within 25 pulses. C
6.4 CAL required a HV > 2000V for desired Fluence. C
7.1 DI temp < 60degC when not in warm-up. CW
7.2 DI temp > 70degC while in Ready state. CW
7 - DI SYSTEM FAULT DI pressure switch does not change when power turned on. OR CW
7.3
DI pump is not ON or DI pressure switch not actuated.
DI temp < Thermistor Open Temperature (5) OR C
7.4
DI temp > Thermistor Shorted Temp (98) while in Ready state
DCD pressure < 105 psi while in READY & INT_DCD & HP w/DCD & spray setting is non-zero.
8 - DCD PRESSURE 8.1
W
FAULT
8.2 DCD Pressure > 135 psi & INT_DCD W
9.1 DI temperature < 62degC after 60 minute warm-up W
9 - WARM-UP TIMEOUT
9.2 DCD pressure < 105psi after 60 minute warm-up (Only when DCD enabled) W
10.1 HP type changed or unrecognized while in Ready (15 consecutive reads at 50 ms interval) C
10 - DELIVERY SYSTEM
10.4 Fiber not detected while in Ready (15 consecutive reads at 50 ms interval) C
FAULT
10.5 Slider button pressed while in Ready State. Cannot change spot-size while in Ready. C
12.1 On last treatment pulse, the head energy (HD) was 14% lower than expected head energy (xHD). C
12 - ENERGY OUT OF
12.2 On last treatment pulse, the head energy (HD) was 14% higher than expected head energy (xHD). C
RANGE FAULT
12.3 The head energy (HD) of the last pulse > Max Treatment HD Energy of 75 J. C
13 - TRIGGER SWITCH
13 The redundant trigger switches were in two different states for > 1 second while in ready.
FAULT
15 - TRANSMISSION 15.1 Transmission (Tx) is < 70%. (HD or CP energy > 5.0 J) C
FAULT 15.2 Transmission (Tx) is > 100%. (HD or CP energy > 5.0 J) C
WARNING DESCRIPTION
Displays once when DCD Canister Pulse count = 0
(16) REPLACE CANISTER
Displays if canister bubble is detected in Ready and DCD is enabled.
(17) PURGE REQUIRED Bubble percentage is outside of tolerable range (~15% bubbles).
EXIT TO CLEAN WINDOW? Transmission is < 75% - Delivery system degrading - Clean Window

Candela Corporation MGentleLASE Installation Procedure
MGentleLASE Installation Procedure
8503-01-0821, Revision A Candela Corporation Proprietary Page 1 of 8

MGentleLASE Installation Procedure Candela Corporation
Page 2 of 8 Candela Corporation Proprietary 8503-01-0821, Revision A

Candela Corporation MGentleLASE PLUS Installation Procedure
WARNING
FOLLOW THE INSTALLAT ION STEPS IN SEQUENCE TO ELIMINATE

ANY POSSIBLE DAMAGE TO THE SYSTEM.
Equipment Needed:
• Adjustable Wrench
• 2.5 Liters of Distilled Water
Laser System Unpacking
1. Using the adjustable wrench, remove the front of the crate. Keep the front nearby
to use as a ramp to roll the laser system from the crate.
2. Remove the accessories located on each side of the laser system from the crate.
3. Place one end of the front of the crate on the floor. Butt the other end against the
floor of the crate. Grasp each handle and gently roll the laser out of the crate.
WARNING: Rear wheels must be

locked when removing laser from
crate. Failure to have rear wheels Rear wheels locked
locked could result in the laser
coming off the ramp.
4. Move the laser to the room that has been prepared for its use. Make sure the
required space and electrical requirements are met. To prevent the laser system
from moving inadvertently, lock each front wheel.

Installation Procedure Candela Corporation
Coolant System Filling
WARNING
DO NOT TURN THE SYSTEM ON WITHOUT FIRST ADDING THE

DISTILLED WATER.
1. Remove the black cap on the reservoir, located on the rear of the laser.
2. Add distilled water up to within ½ to 1 inch of top of reservoir.
Always use distilled water when filling the reservoir. Using water that is
not distilled will result in poor flashlamp performance, and may result in
permanent flashlamp damage.
3. Replace the black cap on the reservoir.
4. Plug the male end of the power cord into the approved outlet.
5. The fluid lines within the laser must now be filled with water. To do this, turn the
system on for 2 minutes. Then repeat steps 1-3 until the water level inside the
reservoir remains at within ½ to 1 inch of top of reservoir.

Initial Cryogen Canister Installation
Figure 1 Canister and Delivery System Locations
Valve
Calibration
Control
Port
Receptacle
Cryogen
Line
Display Receptacle
Panel
Fiberoptic
Laser Stop Receptacle
Switch
Ready
Lamp
1. Remove the DCD cryogen canister from the packaging box. Be sure to read all
labels on the canister before installing into the system.
2. Insert canister threaded side down into the opening on the top left side of the laser
system. Turn canister clockwise until hand tight. A small amount of cryogen
might vent out. The sound of the escaping gas may be quite loud. Only after the
canister is fully seated will the gas stop venting out.
3. Place the cylindrical canister cap over the cryogen canister.

Handpiece Assembly Installation
Refer to figure 1 for handpiece assembly system connection locations.
Figure 2 Delivery System and Handpiece Assembly
Insert distance
gauge here
A- Handpiece Control Connector

D F
E
B- Cryogen Output Connector
C- Fiber Proximal End
D- Glass Windows
E- Distance Gauge
F- O Ring
1. Remove the handpiece assembly from the accessory kit package.
2. With the system turned off, place the distal end of the handpiece assembly into
the calport.
3. Connect the handpiece control (round, electrical plug) connector to the handpiece
control receptacle on the front of the laser system.
4. Connect the cryogen output connector to the cryogen output receptacle on the
front of the laser system as follows: Using both hands, push the knurled
connector on the front of the laser system away from you while gently pushing the

mating connector into the knurled connector until it stops. Release the knurled
connector.
Distance Gauge Installation
Refer to figure 2 above for distance gauge location.
Note
The distance gauge must be removed before performing

the calibration procedure.
1. Insert the distance gauge into the distal end of the handpiece delivery system.
Fiber Assembly Installation
Refer to figure 1 for fiber assembly system connection locations.
1. With the system turned off, remove the protective cap on the proximal fiber
receptacle located on the front of the system.
2. Remove the fiber assembly from its package.
3. Remove the cap from the distal end of the fiber. Slide the distal end of the fiber
into the HP Slider until it clicks firmly into place.
4. Insert the proximal fiber connector into the proximal fiber receptacle, located on
the front of the system, until it clicks into place and stops.
5. Refer to the Operator Manual for a description of the controls and indicators.
Footswitch Installation
Refer to figure 1 for foot/fingerswitch connection locations.
1. Remove the footswitch from its package.
2. Attach the tubing end to the bulkhead connector on the rear panel of the laser.

RELOCATION
Care should always be taken when moving the GentleLASE PLUS. The system was
designed to be moved, but special care should be taken when thresholds, elevator
doors, ramps, and other uneven or sloping floor surfaces are encountered. A severe
physical shock could cause the alignment of the laser head or the optical fiber to be
disturbed. Furthermore, if the system is allowed to get out of control when being
moved, personal injury or physical damage could result.
If it becomes necessary to relocate the GentleLASE PLUS, call Candela or the

distributor for details. Failure to do so may result in damage to the system, and may
void any warranty.

Candela Corporation MGentleLASE Routine Preventative Maintenance Procedure
MGentleLASE Routine Preventative

Maintenance Procedure

MGentleLASE Routine Preventative Maintenance Procedure Candela Corporation

This procedure covers the routine preventative maintenance (PM) required for the
MGentleLASE laser system, which must be performed every twelve months or 500K pulses,
which ever comes first. The purpose of this procedure is to replace the DI Water and Dust
filters, HP Slider or Fiber window, inspect optics and verify system calibrations.
WARNING
DURING THIS PROCEDURE IT IS POSSIBLE THAT THE LASER MAY

FIRE, EMITTING LASER RADIATION. THEREFORE SAFETY EYEWEAR
MUST BE WORN. THE EYEWEAR MUST HAVE AN OPTICAL DENSITY OF
AT LEAST 5.8 AT 745 - 765 NM.
THE ELECTRICAL AND LASER RADIATION HAZARDS PRESENT DURING

SERVICING OF THE MGENTLELASE LASER SYSTEM CAN BE
EXTREMELY DANGEROUS IF PROPER SAFETY PRECAUTIONS ARE
NOT TAKEN. CONSEQUENTLY, THE LASER IS TO BE SERVICED ONLY
BY THOSE QUALIFIED TECHNICIANS WHO HAVE RECEIVED
APPROPRIATE TRAINING ON THE GENTLELASE LASER SYSTEM
FROM CANDELA, AND WHO ARE FAMILIAR WITH THE SAFETY
CONSIDERATIONS DISCUSSED IN THIS SECTION.
USE OF CONTROLS OR ADJUSTMENTS OR PERFORMANCE OF

PROCEDURES OTHER THAN THOSE SPECIFIED HEREIN MAY RESULT
IN HAZARDOUS RADIATION EXPOSURE.
PROCEDURE:
1. Record the "Before" test data sheet.
2. Turn off the laser and unplug the laser from the wall. Remove all skins.
3. Remove the dust filter attached to the front of the chassis. Apply the new dust filter to
the front of the chassis.
4. Remove the two dust filters in the bottom of the fluid section. Apply the new dust
filters to the bottom of the fluid section.
5. Drain the DI water using the drain valve in the fluid section near the heater manifold.
6. Fill the DI reservoir with distilled water only to within ½ -1 inch of top. Turn the laser
on.
7. Check for leaks. Fill the DI reservoir to the proper solution level.
8. Inspect, clean or replace beam splitter in Head detector assy.

Routine Preventative Maintenance Procedure Candela Corporation
9. Turn the laser off. Replace skins on the laser.
10. Turn laser on and wait until warm-up period is finished.
11. Replace the window on the distal end of the Slider or Fiber. This allows for a more
accurate calibration and improved performance of the laser.
12. Complete the checklist below.
13. Perform the tests on the “After” test data sheet.

PROCEDURES/CALIBRATIONS
Note: All procedures are located in the Service section of the Service Manual
1. Check High Voltage calibration. Complete _________
2. Check Fluid Temperature calibrations. Complete _________
3. Check the DCD Pressure. Complete _________
4. Replace the window in the Fiber. Clean or replace

HP lens or lens cap. Complete _________
5. Clean or replace focusing lens (lens cell). Complete _________
6. Verify Head detector calibration. Complete _________
7. Verify aiming beam calibration. Complete _________
8. Verify the laser rail and fiber alignment. Complete _________
9. Calibrate Calport Detector.

Be sure all Sliders have a clean window. Complete _________
10. Verify the DCD Bubble circuit calibration. Complete _________
11. Calibrate all spot sizes of both fibers. Complete _________
12. Record the "After" test data sheet. Complete _________

Routine Preventative Maintenance Procedure Candela Corporation

Candela Corporation GentleLASE Flashlamp Replacement Procedure
MGL & GentleLASE FLashlamp

Replacement Procedure
8503-01-0560, Revision C PROPRIETARY Page 1 of 5

GentleLASE Flashlamp Replacement Procedure Candela Corporation
Page 2 of 5 PROPRIETARY 8503-01-0560, Revision C

FLASHLAMP REPLACEMENT
NOTE: Exercise extreme care. Cleanliness of optics is essential. Refer to

Service Procedure 8503-01-0060 for optic cleanliness.
For GL systems refer to drawings 7121-99-6700 and 7121-99-6780 for specific
details.
For GL Plus, GL 18mm and GL LE systems refer to drawings 7121-99-6700 and
7121-99-9390 for specific details.
For GL systems refer to drawings 7121-99-6700 and 7122-99-3298 for specific
details.
Appropriate optic handling precautions and techniques must be followed in order for
the laser to operate for its maximum lifetime. Clean powderless finger cots or gloves
must be worn when handling the GentleLASE flashlamps. The flashlamps are both
fragile and expensive. Therefore, it is important to handle them carefully. Some
additional suggestions are: keep these components in their containers until they will
be installed into the assembly. Hold them over the bench, not over the floor. If they
need to be put down, lay them on clean piece of lens tissue over a piece of foam
such as in a typical optics container.
Avoid the need to clean the optics other than by gently blowing the dust off of them
with filtered, compressed nitrogen or air. Lightly wipe with methanol, acetone, or
propanol if necessary.
1. Remove the Laser Head per the Laser Head Replacement Procedure. Place on
open flat surface.
2. There are two lamp o-ring retainer end cap plates for each flashlamp located at each
end of the laser head. These retainers are what hold the flashlamps in place.
Remove the two screws of each o-ring retainer end cap plate that secure the
flashlamps. Pay attention to component order when disassembling.
3. Remove the flashlamps from the laser head.
4. Thoroughly clean the new flashlamps so that they are free of fingerprints. Also clean
the flashlamp wires so that when the lamps are installed into the cavity channels, no
contamination occurs.
5. Install the flashlamps in the proper orientation per drawing 7121-99-6700. Install new
o-rings on each end of the flashlamps. Push the o-rings into the o-ring grooves.
Make sure that the flashlamps are evenly positioned in the pump cavity.
6. Clean and then carefully place the lamp o-ring retainer end cap plates over each end
of the lamps and fasten into place with screws.
7. Install the Laser Head on the Monolithic Laser Rail. Refer to 7121-99-6780, 7121-99-
9390 or 7122-99-3298 drawing for specific details. Be sure to tighten the screws until
the lock washers just start to compress. Do not flatten lock washers.

GentleLASE Flashlamp Replacement Procedure Candela Corporation
8. Perform an alignment verification; for GL systems refer to Service Procedure 8503-
01-0610; for GL PLUS, GL 18mm and GL LE refer to Service Procedure 8503-01-
0690; for MGL refer to Service Procedures 8503-01-0825 and 8503-01-0826.


Candela Corporation GentleLASE Handpiece Lens Replacement Procedure
MGL & GentleLASE Handpiece Lens

Replacement Procedure

GentleLASE Handpiece Lens Replacement Procedure Candela Corporation

Candela Corporation GentleLASE Handpiece Lens Replacement Procedure
HANDPIECE LENS REPLACEMENT
NOTE: Exercise extreme care. Cleanliness of optics is essential. Refer to

Service Procedure 8503-01-0060 for optic cleanliness. Refer to drawing 7121-99-
6980, 7121-99-7240, 7121-00-3350, or 7121-00-3351 for specific details.
1. Remove Fiber assembly from Delivery System and laser. Place on an open flat
surface.
2. Remove the screw (or screws, some have 2) that secure the handpiece lens cap at
the distal end of the fiber assembly. Pay attention to the component order when
disassembling.
3. Remove both optics, o-rings and the one spacer from the handpiece lens cap:
• Pry out first lens with an Exacto knife or turn barrel upside down and tap on a
table to dislodge the lens.
• Pry out the first o-ring.
• Remove spacer.
• Push out the second lens.
1. Inspect the o-rings. If cracked or defective, discard and replace. If o-rings need to be
cleaned, use only Propanol, lens tissue, and/or cotton swabs. If possible, blow off
with filtered compressed air / nitrogen.
2. Re assemble per drawing 7121-99-6980, 7121-99-7240, 7121-00-3350, or 7121-00-

3351 - Fiber Assembly as follows:
3. Install the first o-ring only (the o-ring closest to the end without the holes) into the lens
cap and fully seat the o-ring into the o-ring groove. Clean lenses if needed per
procedure mentioned above. Also inspect and clean spacer, if needed, with propanol
or methanol. When satisfied that the lenses and spacer are clean, blow off each item
with filtered compressed air / nitrogen, if available.
4. Position the distal end of the fiber facing up. Carefully stack the two lenses with the
spacer in between them onto the distal end of the fiber. Lens orientation is “belly-to-
belly” per drawing 7121-99-6980, 7121-99-7240 or both flat sides toward fiber per
drawing 7121-00-3350, and 7121-00-3351. Insert the lenses and spacer into the lens
cap. Once the lenses are fully inside the cap, gently tap the side of the cap to
properly set the lenses against the spacer. Continue inserting the lenses until they
stop, which indicates the first lens has reached the first o-ring. Slowly push the cap
against the distal end of the fiber to push the first lens passed the first o-ring. While
holding the distal end of the fiber face up, carefully remove the cap from the fiber. Be
careful, the second lens and possibly the spacer may come out!!
5. Re-install the spacer, if necessary, and install the second o-ring into the groove
above the spacer. Position the second lens onto the distal end of the fiber (facing up,
convex side up) and insert it into the cap, again pushing after it stops to push the
GentleLASE Handpiece Lens Replacement Procedure Candela Corporation
second lens past the second o-ring. Remove the cap to verify that the lens does not
come out, indicating proper lens seating. When shaken, a lens cap with properly
seated lenses will not rattle.
6. When satisfied that the lenses are installed properly, hold the lens cap vertically (fiber
end facing up) and carefully blow any debris out from the lens barrel using filtered
compressed air / nitrogen (at low pressure, if available). Visually inspect lenses for
acceptability. Continue when satisfied.
7. Holding the lens cap assembly vertically, slide the distal end of the fiber assembly all
the way into the lens cap until the fiber assembly butts up against the lens inside the
lens cap. Make sure the gap between the end of the lens cap and the shoulder on the
distal end of the fiber assembly is between .025” and .035”.
8. Firmly, but gently, hold these parts together and secure with screw (or screws).

Candela Corporation MGentleLASE HVPS Calibration Procedure
MGentleLASE HVPS Calibration Procedure

MGentleLASE HVPS Calibration Procedure Candela Corporation

HVPS CALIBRATION
CAUTION !!
During this procedure it is possible that the laser may fire, emitting laser radiation.
Therefore SAFETY EYEWEAR must be worn. The eyewear must have an optical
density of at least 5.8 at 745 - 765 nm.
The high voltages present in this system are LETHAL. This procedure must be
performed only by those technicians who are familiar with the precautions required
when working with high voltage systems, and those who have been trained on the
MGL system and its particular hazards.
WARNING!!!!!
BEFORE WORKING WITHIN THE HV SECTION, ALWAYS DUMP THE HIGH VOLTAGE BY
SELECTING CHRG DISABLE FROM THE TOGGLE SCREEN, PULSING ONCE, THEN
ENTERING STANDBY. THERE WILL STILL BE ABOUT 150 V ON THE FLASHLAMP
CATHODE, SO THIS SHOULD BE DISCHARGED WITH THE DISCHARGE STICK.
ALWAYS MEASURE THE VOLTAGE AT THE FLASHLAMP CATHODE BEFORE
WORKING ON THE LASER RAIL.
WARNING – LASER LIGHT!!!

DURING THE HVPS TESTING, SOME LASER LIGHT WILL EXIT THE FIBER
RECEPTACLE. THEREFORE, BE SURE TO PUT A BEAM BLOCK AT THE OUTPUT
OF THE RECEPTACLE.
1. Remove the laser box cover.
2. Checking the bias voltage: IN STANDBY state. Connect the high voltage DVM probe
to measure the voltage on the laser rail mid way at the terminal where the two
flashlamp wires are connected together. Connect the high voltage probe ground lead
to chassis ground. Verify the voltage is 2200 VDC to 2600 VDC.
3. Checking the trigger pulse: Go to READY state. Set the high voltage to 0 volts using
the maintenance mode ‘HV Ctrl’ Screen. Pulse the laser and verify that a small flash
occurs at each flashlamp indicating the presence of a trigger pulse. Do not proceed
to the next step unless proper triggering of the lamps is achieved. Go to STANDBY
state and replace the laser box cover. In toggle screen press “Shttr Ctrl” to close
beam shutter. Verify “Shttr State” is highlighted.
4. Install the 1000:1 DVM high voltage probe on one terminal of the PFN capacitor.
Secure the probe in position and connect its ground lead to chassis.
5. On the HV CTRL screen, verify that the Charge Enabled button is highlighted.
Highlighted is the enabled condition. Adjust the high voltage setting for Voltage =
2000V.

MGentleLASE HVPS Calibration Procedure Candela Corporation
6. Go to Ready. Verify that the high voltage charges up. Adjust potentiometer R147 on
the CPU I/O PCB so that the DVM on capacitor reads 2.000 VDC (2000 V) ±
0.002VDC.
7. Adjust potentiometer R131 on the CPU I/O PCB so that the high voltage sample on
the maintenance screen reads 2000 V ± 5 V.
8. Set the high voltage to 1000 volts using the display panel. DO NOT PULSE THE
LASER. Allow the voltage to bleed down to 1200 V then pulse once. Verify the actual
high voltage on the DVM is 1.000 VDC (1000 V) ± 6VDC.
9. Verify that the high voltage sample on the maintenance screen is 1000 volts ± 9 volts.
10. Go to STANDBY. Press the Charge enabled button to disable the charge (not
highlighted) and go to READY. Pulse the laser to discharge the remaining voltage.
Use the discharge stick to completely discharge the three PFN capacitors. Go to
STANDBY. Remove all probes from the high voltage section and replace the plastic
shield.
11. Go to Standby state. Turn the laser off. Replace the laser box cover.


Candela Corporation MGentleLASE Head Detector Calibration Procedure
MGentleLASE
Head Detector Calibration Procedure

MGentleLASE Head Detector Calibration Procedure Candela Corporation
Page 2 of 4 Candela Corporation Proprietary 8503-01-0825 Revision A

Candela Corporation MGentleLASE Head Detector Calibration Procedure
CAUTION !!
WARNING!!!!!
BEFORE WORKING NEAR THE HEAD, ALWAYS DUMP THE VOLTAGE BY

SELECTING CHRG DISABLE FROM THE TOGGLE SCREEN, PULSING ONCE,
THEN ENTERING STANDBY. THERE WILL STILL BE ABOUT 150 V ON THE
FLASHLAMP CATHODE, SO THIS SHOULD BE DISCHARGED WITH THE
DISCHARGE STICK. ALWAYS MEASURE THE VOLTAGE AT THE FLASHLAMP
CATHODE BEFORE WORKING ON THE LASER RAIL.
NOTE: If the OPHIR NOVA display is used, be sure the wavelength is set to
YAG or <800, depending on the meter head being used.
1. Remove the Delivery System.
2. Remove the laser rail dust box.
3. Remove the shutter and mount with one screw above fiber focusing assy. In
dust cover mounting hole so it can safely actuate.
4. Remove the fiber receptacle.
5. Set up the Energy Meter Bracket (7122-00-3370). Place the Energy meter in
place.
6. Go to the HV CTRL screen. Put on eyewear and enter READY.
7. Type in 1200 V and pulse the laser a few times, verifying that the beam is
centered on the meter by centering the aiming beam on meter face.
8. Using a DVM, ensure that you measure 0.0v, + .5mv between TP 5 & A GND.
Adjust if necessary. REMOVE THE DVM. (Necessary with new CPU/IO PCB
only)
9. Adjust the voltage until the OPHIR reads 38 – 42 Joules. Adjust the head
detector high POT on the CPU I/O PCB, R35, until the head energy displayed
on the laser display (MM Mode) equals the OPHIR energy within 0.5 J.
MGentleLASE Head Detector Calibration Procedure Candela Corporation
10. Adjust the voltage for 9.0 – 9.5 Joules. Adjust the head detector low POT on the
CPU I/O PCB, R56, until the head energy displayed on the laser display (MM
Mode) equals the OPHIR energy within 0.15 J.
11. Repeat Steps 8 and 9 until both conditions are met.
12. Adjust the voltages until the OPHIR meter reads 59 - 61 Joules. Verify that the
head detector reading agrees with the OPHIR reading within ±1.5 J. If it doesn’t,
adjust R35. Repeat Steps 8 to 11 until all conditions are met.
13. Replace the fiber receptacle.
14. Replace the shutter and mount.
15. Replace the laser rail dust box.
16. Replace Delivery System.
17. Remove the energy meter and the Energy Meter Calibration Kit.
Page 4 of 4 Candela Corporation Proprietary 8503-01-0825 Revision A

Candela Corporation MGentleLASE Laser Rail Alignment Procedure
MGentleLASE Laser Rail

Alignment Procedure

MGentleLASE Laser Rail Alignment Procedure Candela Corporation

Candela Corporation MGentleLASE Laser Rail Alignment Procedure
LASER RAIL ALIGNMENT Procedure
CAUTION !!
WARNING!!!!!
BEFORE WORKING NEAR THE HEAD, ALWAYS DUMP THE VOLTAGE BY

SELECTING CHRG DISABLE FROM THE TOGGLE SCREEN, PULSING ONCE,
THEN ENTERING STANDBY. THERE WILL STILL BE ABOUT 150 V ON THE
FLASHLAMP CATHODE, SO THIS SHOULD BE DISCHARGED WITH THE
DISCHARGE STICK. ALWAYS MEASURE THE VOLTAGE AT THE FLASHLAMP
CATHODE BEFORE WORKING ON THE LASER RAIL.
NOTE: If the OPHIR NOVA display is used, be sure the wavelength is set to
YAG or <800, depending on the meter head being used.
1. Remove fiber/delivery system if installed.
2. Install the energy meter bracket, P/N 7122-00-3370, under the front bezel and
install the energy meter onto the bracket.
3. Put on eyewear, go to maintenance mode and on the HV control screen enter

READY.
4. Adjust the voltage for 6.5 – 7.1 J on head detector. Attach black electrical tape
to the alignment plug tool, P/N 7712-00-3363, and imprint the plug’s cross hair
onto the tape with a fine ball point pen. Install the plug into the receptacle facing
the shutter so the cross hair is oriented vertically and horizontally. Put a bag in
front of the plug and pulse the laser in order to make a burn on the tape. If the
cross hair mark gets burned off, re-mark it with a fine pencil or pen.
5. Measure the centering of the burn with respect to the cross hair. Record it
below. It must be 0.5 mm or less vertically and horizontally. Be sure to divide
by 2 if you measure the beam centering by measuring the difference between
the distance from each beam edge to the cross hair. For example, if the top
edge of the beam is 2.0 mm from the cross hair and the bottom edge of the
beam is 2.5 mm from the cross hair, then the difference is 0.5 mm and the
beam is off center vertically by half this, or 0.25 mm.
Vertical de-centering = ___________ mm (≤ 0.5 mm)
Horizontal de-centering = _________mm (≤ 0.5 mm)

MGentleLASE Laser Rail Alignment Procedure Candela Corporation
6. Adjust the voltage until energy is just measured with the energy meter set at its
lowest range (about 1-2 Joules). Record this voltage. Go into STANDBY and
remove the energy meter.
7. Use the following procedure to verify the alignment of the receptacle using the
alignment tool P/N 7122-00-3362 and to perform an alignment if necessary.
Most alignment tools are slightly decentered, so this procedure also reduces the
error caused by this decenter to a negligible value.
7.1 Put a distinguishable mark onto the back of the alignment tool: Apply red or
black “Sharpie” to the proximal end of the fiber on the alignment tool. Insert
the tool into the receptacle with the mark facing up and pulse ONCE.
7.2 Remove the tool and inspect the tool with an eye loupe or a magnifier, keeping
the mark on the tool in the up position. The ink from the “Sharpie” will be gone
where the beam hit.
7.3 Draw a sketch of the beam location.
7.3 Rotate the connector so the mark is facing down and repeat Steps 6.1 to 6.3.
Be sure to look at the end of the fiber with the mark down this time. Sketch
this beam location.
7.4 If the location of the burn has changed from the previous step, then the tool
has a decenter error. The actual beam location is the middle of the two beam
locations. At the actual beam location, if the thickest “Sharpie” band is more
than twice the thinnest band, then the receptacle must be aligned or replaced.
To align:
• Loosen the two inner (in the slotted holes) 4-40 socket head
screws securing the lens housing assembly to the fiber receptacle
block ¾ turn each. Slightly adjust one of the two set screws,
located on the top (vertical axis) and left (horizontal axis) side of
the fiber receptacle block (do not touch the ball plunger screw on
the right side of the block). Adjust the set screw in the desired
direction (ex: if burn spot is off to the left on the tool, adjust the lens
housing towards the right (looking at the beam input side of the
fiber receptacle)).
• Perform the “Sharpie” burn and re-adjust until alignment is

acceptable.
• Tighten the two 4-40 screws evenly and repeat the two “Sharpie”
burns to make sure nothing has shifted.
8. Clean the fiber alignment tool’s tip with a cotton applicator and solvent when
finished and replace caps to both ends of the tool.
9. Press Charge enabled so it is not highlighted on the HV Ctrl screen and pulse
once to discharge the caps. Go to STANDBY.
10. Install the laser rail dust cover.

Mini-GentleLASE SYSTEM PERFORMANCE & USAGE DATA
Customer Name ________________________ Date __________ Laser S/N __________
Service Engineer ____________________
Energy Meter Serial Number _______________ Calibration Due Date _________________
------------------------------------------ BEFORE SERVICING DATA -------------------------------------------
SOFTWARE REV _______ LASER HEAD S/N _________ TOTAL PULS _____________
Head Detector, fiber installed
CANISTER MASS DI TEMP HIGH VOLTAGE @ 60J
_________________ ____________C __________________V
Into Meter Into Meter

DELIVERED ENERGY DELIVERY TRANS. CP CP Transmission
___________J _________% ___________J ____________%
LIST FAULTS:
--------------------------------------------- AFTER SERVICING DATA -------------------------------------------
SOFTWARE REV ________ LASER HEAD S/N _________
LINE VOLTAGE____ 180-250v DI WATER TEMP______ 65±3ºC DCD PRES_____120± 5 PSI
HV REF@1500VDC___________1500±5VDC HV SMP@1500VDC___________1500±5VDC
BUBBLE SENSOR Cryo 7.75±.0.5VDC No Cryo >11VDC

12-18MM H/P
6-10MM H/P
Canister
Head Detector, Fiber installed Into Meter
HIGH VOLTAGE @ 60 J HEAD _________ <1700 (≤25K Head Pulses) DELIVERED ENERGY_________J
<1800 (25K-50K) 12-18MM DELIVERY TRANS. ______% >80%
CP Transmission: ___________% <1900 (>50K) 6-10MM DELIVERY TRANS. ______% >80%
AIMING BEAM VISIBLE AT LEVEL 1 W/ 18 MM SPOT SIZE THROUGH GOGGLES: _____________
VERIFY 20 msec, 3ms DELAY, 0 POST SPRAY DCD PULSE FILLS 12mm CIRCLE: ____________
Must use MGL/GL+ brown ULTEM 12 mm distance gauge, 7121-00-9240 Rev B or higher. Do not use aiming beam.
TOTAL PULSES ______________ HEAD PULSES ______________
CLEAR FAULT LIST AND RESET PULSE COUNTER(S) IF APPLICABLE
10-400-00144 Revision C Candela Corporation PROPRIETARY Page 1 of 1

Mini-GentleLASE PM CHECKLIST
Customer Name:___________________________________ Phone Number:_______________
Engineer:_________________________________________ Serial number:_______________
1. Turn the system on and ensure that the emergency off button
and all system interlocks are functional. _______
2. Let the system warm up and take the “before” data. _______
3. Update and verify all system upgrades are installed. _______
4. Vacuum dust from system and verify all fans are working properly. _______
5. Replace dust filters, three in all. _______
6. Inspect, clean / replace all laser rail optics. _______
7. Inspect the fiber, calport and distance gauges, clean and replace optics if needed. _______
8. Perform the PM per the service manual procedure. Record compliance to it’s
procedures / calibrations below. _______
9. Verify the high voltage calibration. _______
10. Verify the DCD bubble sensor calibration. _______
11. Verify the Canister bubble sensor calibration _______
12. Verify the fluid temperature calibrations. _______
13. Verify the head detector calibration _______
14. Verify the fiber alignment. _______
15. Verify the calport calibration. _______
16. Calibrate all handpiece sizes for calibration tables. _______
17. Inspect plug / wall connections, and all internal wiring for loose or defective contacts. _______
18. Inspect the entire system for workmanship and loose hardware. _______
19. Ensure that all the fuses are properly secured. _______
20. Fully reassemble the laser. _______
21. Take the “after” data, ensuring that the laser meets all specs. _______
22. Clear the fault list. _______
23. Clean the exterior of the laser including the power cord. _______
24. Complete and sign Data sheet, and next PM reminder. _______
25. Insure the room is left in it’s original condition. _______
8502-15-0208 Revision A Candela Proprietary Page 1 of 1

Candela GentleLASE Family Of Lasers Treatment Guidelines
For miniGentleLASE Models: 9914-0880 and 9914-0890

For miniGentleLASE Limited Edition Models: 9914-0910 and 9914-0930
THESE GUIDELINES DO NOT TAKE THE PLACE OF THE OPERATOR’S MANUAL BUT SERVE AS SUGGESTIONS
FOR TREATMENT WITH THE CANDELA GENTLELASE FAMILY OF LASERS. IT IS RECOMMENDED THAT TEST
SPOTS ARE DONE AND TISSUE RESPONSE EVALUATED PRIOR TO FULL TREATMENT. THE ULTIMATE
SELECTION OF PARAMETERS IS UP TO THE INDIVIDUAL ASSESSING THE PATIENT’S NEEDS
HAIR REMOVAL TREATMENT GUIDELINES

PT. SKIN SPOT FLUENCE *DCD *DCD COMMENTS
2
TYPE SIZE (mm) (J/cm ) SPRAY (ms) DELAY (ms)
1-2 6 30-40 40-60 40-60 Start at lower fluence & observe
Red hair, 8 30-40 40-60 40-60 tissue response.
Freckles, Fair 10 25-36 40-60 40-60
skin, Blue eyes
12 25-35 40-60 40-60
(Caucasian)
15 20-30 40-60 40-60
18 14-20 40-60 40-60
3 6 25-40 40-60 40-60 Test spots are recommended.
(Darker 8 25-40 40-60 40-60 Evaluate tissue response1-2 weeks
Caucasian, light later before starting full treatment.
10 18-30 40-60 40-60
Asian)
12 18-30 40-60 40-60
15 16-25 40-60 40-60
18 10-16 40-60 40-60
Use lower energy unless pre-treated with bleaching regimen for skin types 4-6 and tanned skin
IT IS RECOMMENDED TO PRE-TREAT WITH PRESCRIPTION STRENGTH (4%) BLEACHING AGENTS B.I.D. FOR AT LEAST 2
WEEKS ON ALL PATIENTS WITH SKIN TYPE 4-6 and tanned skin . Pre-treat the skin first before doing test spots to get
a true indication of skin response.
4 6 20-30 40-80 40-80 If testing with larger spot size causes
(Mediterranean, 8 20-30 40-80 40-80 too much discomfort, try smaller spot
Asian, Latin) sizes, same fluence. Wait for 1-2
10 16-24 40-80 40-80 weeks after test spot before full
12 16-20 40-80 40-80 treatment.
15 10-20 40-80 40-80
18 8-16 40-80 40-80
5 6 20-25 40-80 40-80 Test small area & wait 1 -2 weeks for
(Middle Eastern, 8 20-25 40-80 40-80 full treatment to evaluate tissue
Latin, Asian light response. Apply cold compress or
10 14-20 40-80 40-80 cold gel packs after treatment to
skinned Black,
Indian, Native 12 14-20 40-80 40-80 reduce discomfort and risk of
American) 15 10-20 40-80 40-80 blistering.
18 6-16 40-80 40-80

6 6 20-25 40-80 40-80 Test small area & wait 1 -2 weeks for
(Dark skinned 8 20-25 40-80 40-80 full treatment to evaluate tissue
Black) response. Apply cold compress or
10 10-20 40-80 40-80 cold gel packs after treatment to
12 10-20 40-80 40-80 reduce discomfo rt and risk of
blistering.
8502-00-0858 Revision B Candela Proprietary Page 1 of 5

15 6-20 40-80 40-80

18 6-16 40-80 40-80


TELANGIECTASIA (2-3mm) TREATMENT GUIDELINES

PT. SKIN SPOT SIZE FLUENCE *DCD *DCD COMMENTS
TYPE (mm) (J/cm2) SPRAY (ms) DELAY (ms)
8 50-80 (leg) 50-70 30 - 70 Pulse each area once
1-3 8 40-50 (face) 50-70 30 - 70 Endpoint is perivascular erythema,
subtle edema of vessel, or no
vessel re-fill.
Wrinkles TREATMENT GUIDELINES

2)
TYPE (mm) (J/cm SPRAY (ms) DELAY (ms)
1-5 12 25-40 40-60 40 - 60 May apply cold compress or cold gel
packs immediately after treatment to
cool skin and remove heat
*DCD is an Option. If DCD is not used another form of epidermal cooling should be used . Skin cooling reduces the rise in temperature in the
epidermis, allows for higher tolerated fluences and provides partial anesthesia. Ice may be applied immediately before treatment to cool skin and
after treatment to remove heat.
**Note : The DCD contains an optional Post Spray feature. This feature provides additional cooling and may enhance
patient comfort if needed. When using this optional feature, user should start at low settings and
observe patient response.
BENIGN PIGMENTED LESIONS TREATMENT GUIDELINES

( Seborreheic keratoses, solar lentigines, benignmelanocytic nevi)
2)
TYPE (mm) (J/cm SPRAY (ms) DELAY (ms)
8 30-40 0 0 Apply ice slurry pre and post
1-4 treatment to cool skin and remove
heat. Aloe Vera gel may be added to
10 30-40 0 0 ice to make gel slurry. Start at
lowest fluence for treatment one and
12 30-40 0 0 observe tissue response. Start by
treating darkest lesion and lowest
fluence and observe tissue
response. Lighter spots may require
higher fluence and darker spots
may require lower fluence
NOTE: TREATMENT OF BENIGN PIGMENTED LESIONS WITH GENTLELASE ON SKIN TYPES 5 OR 6 IS NOT RECOMMENDED.
NOTE: THE DYNAMIC COOLING DEVICE (DCD) IS NOT USED FOR THE TREATMENT OF BENIGN PIGMENTED LESIONS AND
SHOULD BE TURNED OFF


GENERAL TREATMENT CONSIDERATIONS
SUGGESTIONS FOR TREATMENT
ALWAYS HOLD LASER HANDPIECE PERPENDICULAR TO SITE TO APPLY LASER ENERGY FOR HAIR REMOVAL
PROCEDURES. A RED AIMING BEAM IS PROVIDED TO ILLUMINATE THE TREATMENT AREA. THE AIMING BEAM AND
TREATMENT BEAM ARE DIMENSIONALLY IDENTICAL, SO THE AIMING BEAM CAN BE USED TO ACCURATELY DEFINE THE
TREATMENT PULSE LOCATION AND SHOULD APPEAR AS A RED CIRCULAR SPOT WHEN THE HANDPIECE IS
PERPENDICULAR
Warning
When treating patients with GentleLASE Models 9914-0890 or 9914-0930 while using an ECG monitoring devi ce attached to a
patient, electrical interference with the ECG monitoring device may result.
Expected Responses
§ Perifollicular edema /erythema; possible responses: welting (secondary to histamine response), and mild to moderate
itching.
Untoward effects
§ Blistering, hyperpigmentation, hypopigmentation, scarring, purpura or herpes simplex activation. These effects may occur
and may be transient or may last for months post treatment. In rare cases hyperpigmentation or hypopigmentaton or
scarring may be permanent.
§ For type V or VI skin or tanned skin , final skin responses may not often be visible for 1-2 weeks. Perform test spots on an
inconspicuous area prior to treatment.
Recommendations for preventing untoward effects and/or decrease discomfort

§ Cold compress or cold gel packs should be applied immediately after treatment, until area is cool to touch.
§ Large areas that are divided into sections need to be cooled as the sections are treated.
§ Test small areas in inconspicuous locations where treatment will be given BEFORE treating a large area.
Skin Preparation for Treatment

§ Topical anesthetics may be used per manufacturers directions HOWEVER, remove any topical anesthetics from the skin
prior to treatment, and degrease skin with soap and water.
§ Skin must be clean and dry; remove all lotions, perfumes, make-up, deodorant, etc.
§ Ethanol should NOT be used to clean skin.
§ Shave area to be treated immediately before treatment; DO NOT leave any stubble on skin. DO NOT treat long hair, as the
external hair acts as a heat sink and may cause skin damage.
§ DO NOT have patient tweeze, wax or have electrolysis 6 weeks before treatment.
Reduction of Plume and Hair Odor in Treatment Room

§ Use a smoke evacuator during treatment; especially for treatment of larger areas. (OSHA standards)


§ Wear a laser mask to reduce breathing plume.

§ Keep room well ventilated to disperse hair odor.
CANDELA does NOT recommend treating under the eyebrow as ocular damage may occur.
Treating Specific Body Areas

§ Insert wet cotton in nose or ears during treatment to reduce DCD spray delivery beyond target.
§ When applying laser energy, be sure entire tip of distance gauge is on treatment area to reduce chance of pulse or spray
extending beyond target.
§ Patients with fillings near front teeth MAY experience a sensitive reaction when laser pulse administered above lip; place wet
gauze under upper lip during treatment to reduce this sensation.
§ Before treating full beard or head, BE SURE patient wants this area to remain free of hair and have signed an informed
consent form.
§ Before treating the upper lip, make sure patient does NOT have permanent lip make-up/tattoo, if so, cover with a wet white
product,
§ Use of a white makeup stick or washable marking pen is appropriate for drawing in treatment area grid.
§ When treating anal area, place wet gauze in anus first. Methane gas is flammable.
§ Pre-treat with bleaching regimen for two weeks prior to test spot when treating genital/bikini area.
§ For hair removal: Lower fluences should be used when treating tanned s kin . This includes UV light from a tanning booth
and those tans from tanning creams. Patients have a greater chance of blistering and hypopigmentation when treating
tanned skin. .
§ Tanning Creams should NOT be used within a few days of treatment, and should be removed completely prior to treatment.
§ When treating the inside of the thigh, the skin is generally more sensitive. You may need to decrease energy.
CRYOGEN REORDER - Replacement canisters of cryogen are ordered by the part number listed on the GentleCooltm canisters
shipped with laser. Use only 1000-gram size canisters for this product.

A B C D E
4 4
J1
BUBBLE + 1
BUBBLE - 2
2 1 LED + 3
LED RTN 4
3 3
2
11 3 4 3
HEADER 4
R1 U1 DCD HP SIGNALS
20K POT TOP OPB370N-P55
BUBBLE
ADJUST
2 2
MOUNTING HOLES
Z2 Z4
1 1
PROPRIETARY CANDELA CORPORATION 530 Boston Post Road Wayland, Massachusetts U.S.A. 01778-1883
REV 03 DRAWN OWEN SCHIRDUAN 12-10-01
SIZE DRAWING NO. REV.
ECO# 13019 CHECKED SCOTT MOGREN 12-10-01 This drawing contains confidential information TITLE
DATE 12-10-01 ENG ELEC OWEN SCHIRDUAN 12-10-01
proprietary to Candela Corporation. It must not
be reproduced or disclosed to others or used in
SCHEMATIC, DCD CANISTER PCB
B 7111-80-2520 03
any other way, in whole or in part, except as
CHK'D OKS APPROVED DATE authorized in writing by Candela Corporation. DATE: Wednesday, December 12, 2001 SHEET 1 OF 1
A B C D E

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Candela Corporation Proprietary

Toll Free (800) 733-8550 ext.336 (Technical Assistance)

Page 2 PROPRIETARY 8501-00-1741 Revision A

Use of controls or adjustments or performance of procedures other than

Federal (USA) law restricts this device to sale by or on the order of a

Copyright 2002. All rights reserved. Printed in USA.

8501-00-1741, Revision A PROPRIETARY Page iii

SECTION ONE THEORY OF OPERATION Revision

SECTION TWO FIRMWARE DOCUMENT

SECTION THREE SERVICE PROCEDURES

Page iv PROPRIETARY 8501-00-1741 Revision A

SECTION FOUR ENGINEERING DRAWINGS.................................................................................Revision

8501-02-1741 DRAWING PACKAGE A

7121-00-6700 Bom, Laser Head Assembly ................................................................................ A

8501-00-1741, Revision A PROPRIETARY Page v

Assembly Drawings/BOMs Cont. Revision

7122-00-3306 Bom, DCD Option Assembly, .............................................................................. B

Page vi PROPRIETARY 8501-00-1741 Revision A

SECTION FIVE REFERENCE

8501-00-1741, Revision A PROPRIETARY Page vii

Page viii PROPRIETARY 8501-00-1741 Revision A

2. Description - the machine and its components

3. Controlling the machine - general guidelines

4. Hemodialysis, double needle treatment

5. Hemodialysis, single needle treatment

8. Hemodiafiltration, low volume

9. BVS - Blood Volume Sensor

10.BPM - Blood Pressure Monitor (option)

12.Hygiene and maintenance

13.Technical data and specifications

14.Alarm list, Attention alarm list and Technical alarm

15.Major changes in operator’s manual

3. Controlling the machine - general guidelines

4. Hemodialysis, double needle treatment

5. Hemodialysis, single needle treatment

8. Hemodiafiltration, low volume

9. BVS - Blood Volume Sensor

10.BPM - Blood Pressure Monitor (option)

12.Hygiene and maintenance

Before you get started - general

Chapter 1; Before you get started - general information

Chapter 2; Description - the machine and its components

Chapter 3; Controlling the machine - general guidelines

Chapter 4; Hemodialysis, double needle treatment

Chapter 5; Hemodialysis, single needle treatment

Chapter 8; Hemodiafiltration, low volume

Chapter 10; BPM - Blood Pressure Monitor

Chapter 11; Diascan

Chapter 12; Hygiene and maintenance

Chapter 13; Technical data and specifications

Definitions of expressions used in this manual

This symbol indicates that it is possible to preset the value of a

When unpacking, check the equipment for any signs of damage. If

Patients connected to the AK 200 S should be monitored by

During installation all calibration checks must be completed before

The AK 200 S needs special precautions regarding EMC and

The use of mobile telephones or communication equipment in the

The AK 200 S will perform as designed only if it is used and

The AK 200 S dialysis machine is in compliance with certain

• Machines are not disinfected before delivery. Always perform a

• During transportation and storage the equipment has to be kept in

• For the qualified technician the AK 200 S Service Manual is available.

• It is important that the protective earth in the installation is of high