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AK 95 / AK 95 S

Service Manual

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AK 95 / AK 95 S - Service manual

Contents:

Chapter 1 Installation guide

Chapter 2 Technical description

Chapter 3 Technical data

Chapter 4 Service technician’s guide

Chapter 5 Maintenance manual

Chapter 6 Calibrations

Chapter 7 Spare parts list

Chapter 8 Cable survey

Chapter 9 Symbol description

Chapter 10 Replacements

Chapter 11 Electrical safety inspections

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Preface

About this manual equipment modifications are authorized in


This service manual provides the information writing by the manufacturer and carried out
needed to install the AK 95 or AK 95 S by appropriately trained and suitable
monitor and how to carry out maintenance qualified people; if the electrical installation
and calibrations. of the relevant room complies with all
It is a guidance how to identify and repair applicable local electrical codes and, if
faults that may occur. applicable, IEC requirements; and if the
equipment is used in accordance with the
All information, texts and figures, are valid published Operator’s Manual.
for AK 95 S. If the information is specific for
AK 95 only, it is stated in the corresponding
text.
Maintenance
To ensure proper operation of the AK 95 /
AK 95 S, a qualified service technician must
Installation perform a complete series of maintenance
Installation of the machine should be done in procedures at regular intervals.
accordance with the recommended procedures
in the Installation Guide. The maintenance and calibration information
that you need to use is provided in this
When installing a new monitor kindly Service Manual.
remember to fill out the Installation / Out of
Box report and return it to: It is mandatory to perform at least a
preventive maintenance every second year.
Gambro Lundia AB A yearly maintenance is recommended. The
Monitor Division rate of preventive maintenance might be
Magistratsvägen 16 different due to variations of the operating
PO Box 10101 environment.
SE-220 10 Lund
Sweden
Competence of Service Engineers
This is an important information and it will There is a certain minimum level of
assist us to improve the product for you. The competence required for Service Engineers
Out of Box system is not valid for products, who are to maintain and repair Gambro
components or printed circuit boards that products, summarized as follows.
isn't in its original delivered condition.
A Service Engineer is considered suitable
qualified if he/she has:
Complaint
If a complaint is raised it shall be 1. Practical experience of the AK 95 S
communicated to the relevant Gambro Sales monitor.
Company. In order for the Sales Company to
be able to determine the relevance of a 2. Attended AK 95 S technical service course
complaint, it is of vital importance that the and has been given a certificate stating
deviation is communicated to them as that the technician has passed the course.
comprehensive as the issue requires.
Complaints are important information and it 3. Access to the recommended test
will assist Gambro to improve the product for equipment and special tools detailed in
you. The Complaint system is not valid for this Service Manual.
products, components or printed circuit
boards that isn't in its original delivered 4. Access to the recommended spare parts,
condition. see section Spare Parts List.

Disclaimer 5. Access to and understanding of the


The manufacturer accepts responsibility for AK 95 S Operator's Manual, HCEN9794
the safety, reliability, and performance of this or AK 95 Operator's Manual, HCEN9542.
equipment only if installation, operational
procedures, maintenance, calibrations, and In general, this policy implies that training
repairs are carried out by appropriately will be carried out by Gambro Lundia AB:
trained and suitable qualified people; if all Monitor Division, while local markets are
responsible for their own service
organization.

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Repair
Parts which are sent for repair shall be sent to the
following address:

Gambro Lundia AB
Monitor Division
Workshop
Magistratsvägen 16
PO Box 10101
SE-220 10 Lund
Sweden

Technical support
For technical support please contact your local
Gambro Service representative.

Valid revision

Publication no. Denomination


HCEN9095, Rev. 10.2006 AK 95 / AK 95 S -
Service Manual

The complete AK 95 / AK 95 S - Service Manual,


HCEN9095, consists of the following separate
chapters:

HCEN9133 Rev. 01. 2004 Installation Guide


HCEN9134 Rev. 10. 2005 Technical Description
HCEN9369 Rev. 10. 2005 Technical Data, AK 95S
HCEN9135 Rev. 10. 2005 Technical Data, AK 95
HCEN9136 Rev. 10. 2005 Service Technicians
Guide
HCEN12189 Rev. 10. 2006 Maintenance Manual
HCEN9138 Rev. 10. 2005 Calibrations
HCEN9094 Rev. 10. 2005 Spare Parts List
K16756 CO 25702 Cable Survey
HCEN9160 Rev. 10. 2005 Symbol Description
HCEN12078 Rev.10. 2005 Replacements
HCEN12190 Rev. 05. 2006 Electrical safety
inspections

All rights reserved.


© Copyright Gambro Lundia AB, Sweden, 1996

Gambro Lundia AB
Monitor Division
Box 10101
SE-220 10 Lund
Sweden

Tel: +46 46 16 90 00
Fax: +46 46 16 96 96
www.gambro.com

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Installation Guide
AK 95 / AK 95 S
January 2004

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Installation Guide

1. Installation Guide
Contents
Installation
Unpacking and inspection .......................... 1:2
Environment and ........................................ 1:2
Physical Data .............................................. 1:2
Operating Environment ........................ 1:2
Transport and Storage Environment .... 1:2
Physical Data ......................................... 1:2
Mains Voltage and Power ...................... 1:3
Consumption .......................................... 1:3
Service Outlets ....................................... 1:3
Line Fuses .............................................. 1:3
Mains Water Supply .............................. 1:3
Tools ............................................................. 1:3
Top Tray ....................................................... 1:3
Connection to the Water Supply ................ 1:4
Connection to the Power Supply ................ 1:4
Connection of the battery ........................... 1:4
How to remove the cover to
connect the battery ..................................... 1:5
Installation of RP 95 S ................................ 1:6
Back-up battery ........................................... 1:8
Turn on the AK 95 S .................................... 1:9
Functional check - Fch............................... 1:9
Recommended start-up procedure .............. 1:9
Checklist ..................................................... 1:11

Note!
This installation Guide provides the information needed to
install both AK 95 and AK 95 S.
The text from this point forward only states AK 95 S.

AK 95 / AK 95 S Service Manual
1:1
HCEN 9133 Rev. 01. 2004

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Installation Guide

Installation
Unpacking and Environment and
inspection Physical Data
When unpacking, the equipment should be The AK 95 S can be installed in most environ-
checked. If the equipment is in any way dam- ments if certain conditions as the temperature,
aged, proper operation cannot be guaranteed. relative humidity, mains voltage etc. are met.
Please contact your Gambro Service
representative.
Operating Environment
The packages contain the units and components
shown in Figure 1. AK 95 S:
Ambient temperature: +18 °C to + 35 °C
Relative humidity: 15 % - 85 %
Air pressure: 70 - 106 kPa

AK 95:
Ambient temperature: +10°C to + 35 °C
Relative humidity: 30% - 85 %
Air pressure: 70 - 106 kPa

Transport and Storage Environment


Units being transported or stored must be kept
in their original packaging. Units must be
handled en route in accordance with special
instructions. Units can be transported or stored
in the following environment for up to 15 weeks:

Ambient temperature: -20 °C to +70 °C


Relative humidity: 10 % - 96 %
Air pressure: 50 - 106 kPa

Note! Units to be transported and/or stored for


more than 15 weeks may only be subjected to
the conditions specified under Operating Envi-
ronment.

Figure 1. AK 95 S Units.
Physical Data
Ensure that the specified equipment has been
delivered. Do the packages contain the specified
monitor and options? Are there any units/ AK 95 S:
components missing? Check the additional Depth Width Height Weight
packing list (inside the additional package box). mm mm mm kg
If in doubt, please contact your Gambro Serv-
ice representative. Machine 600 480 1270 78
Stand 625 580 (all options
Ensure that the voltage specified on the voltage included)
tag matches the mains voltage. If in doubt,
please contact your Gambro Service AK 95:
representative. Depth Width Height Weight
mm mm mm kg

Machine 420 350 1270 62


Stand 680 625

1:2 AK 95 / AK 95 S Service Manual


HCEN 9133 Rev. 01. 2004

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Installation Guide

Mains Voltage and Power


Consumption Tools
The AK 95 S must be plugged into a grounded
The tools listed below are needed during the
power point not more than 3 metres distant.
installation procedure.
Mains voltage: • Tube cutter, 113 500 084
100 V(at 50 Hz or 60 Hz) • Adjustable wrench, 113 003 009
110 V(at 50 Hz or 60 Hz) • Hexagon spanner set
230 V(at 50 Hz or 60 Hz) (±12%) • Screwdriver, 1,2 x 8,0 - 175mm,
113 002 006
Power consumption:
2025 W at 230 V
1575 W at 110 V Top Tray
1275 W at 100 V To avoid leakage into the machine, the top tray
must always be placed on the top of the ma-
Service Outlets chine, except during technical service.
One extra grounded power socket should be
available close to the AK 95 S, for troubleshoot-
ing and maintenance purposes.

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

Mains Water Supply


Required quality:
Level of purity according to ASAIO and AAMI
recommended standards on feed water for
dialysis monitors.
Water for the dialysis unit has to be supplied
from a Reverse Osmosis purification system.

Pressure:
1.2 - 6 bar to the pressure regulator mounted in
the MM 95. A
B
Acetate

Lift points Lift points


Note! The pressure should be measured with
the flow from the water supply.

Temperature:+5 °C to +30 °C (treatment)

Consumption in treatment:
AK 95 S: 500 ml/min
AK 95: 550 ml/min

Drain: Open type. Not more than 1.2 metres


EN1075

above outlet from fluid monitor.

Note! Local ordanances may require the use of


special measures to protect against the possibil-
ity of back-siphonage from dialysis equipment
Figure 2. AK 95 S
into the water supply. When installing the
AK 95 S, such ordanance should be observed.

AK 95 / AK 95 S Service Manual
1:3
HCEN 9133 Rev. 01. 2004

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Installation Guide

Connection to the Water Connection of the Battery


Supply The rechargeable 9V battery (100 224 006) is
The water must fulfil all requirements set out used to drive the buzzer alarm during main’s
under Environment and Physical Data. power failure. The battery is not connected at
delivery.

Water in

Drain
NOTE! The battery must be connected during
the installation according to the instruction on
next page.

Connection to the Power A discharged battery will be charged with


maximum 10 mA and it must be charged for at
Supply least 50 hours to get completely charged. An all-
up charged battery will receive a maintaining
Fuses current of approximately 1,5 mA. The AK 95 S
Main switch, charge the battery as long as the AC/DC con-
ON/OFF verter is switched on, i.e. AK 95 S itself does not
need to be switched on.

The battery is tested during every functional


check to ensure that the capacity is enough in
the battery, otherwise an attention will be
given:

BATTERY FAILURE
Change battery or press SELECT

NOTE! Jumper J200 on the Protective Driver


board must be mounted for the rechargeable
Mains power, battery.
connected to a If use of an alkaline non-chargeable battery,
grounded jumper J200 must be removed, if not, the
power socket battery will be damaged.

1:4 AK 95 / AK 95 S Service Manual


HCEN 9133 Rev. 01. 2004

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Installation Guide

How to remove the cover to connect


the battery.
1. Loosen the three cover bolts, accessible
underneath the fluid part.
A
2. Move the cover upwards and then back-
wards.

3. Pull the cover to the right just 10 mm (if you


are positioned in front of the AK 95 S).

4. Turn the cover backwards counter-clockwise


to pass the circuit boards and the cover can
be removed.

Cover B
A Acetate

A A

Front
1070

5. Connect the rechargeable battery to board


connector P205 on the Protective Driver
board.

AK 95 / AK 95 S Service Manual
1:5
HCEN 9133 Rev. 01. 2004

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Installation Guide

Installation of RP 95 S
NOTE! This instruction is for AK 95 S equipped with RP 95 S at delivery.
RP 95 S can also be ordered and installed as a kit, K23054. Refer to rebuilding instruction K23055.

Step 1
3 4
1. Loosen the two screws (with
MB
RO

black plastic knobs) under the


service tray holder.

2. Pull out the service tray holder


to its end position.
2 5
3. Loosen the two hexagonal
socket screws.

4. Remove the service tray holder


complete. GAMB
RO

5. Fasten the hexagonal socket 1 6


screws again. GAM
BRO

6. Attach the plug to the rear hole


of the stand and fasten the
screw (with black plastic knob).

Step 2

1. Put the RP 95 S unit into the front hole


of the stand. Fasten it with the attached
spacer and screw (∅ M4, 16mm) GAM
BRO

2. Fasten the screw (with black plastic


knob).

1:6 AK 95 / AK 95 S Service Manual


HCEN 9133 Rev. 01. 2004

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Installation Guide

180°
Step 3

1. Turn the RP 95 S 180° in counter


clockwise direction.
90°

2. Rotate the RP 95 S 90° to be


parallel with the AK 95 S front.
GAM GAM
BRO BRO

Step 4

1. Fasten the cable on the right upper


part of the stand with the enclosed
cable holder and screw.

2. Fasten the cable even on the back


part of machine with the enclosed
cable holder - use an existing screw.
1 2

AK 95 / AK 95 S Service Manual
1:7
HCEN 9133 Rev. 01. 2004

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Installation Guide

Back-up Battery
The optional back-up battery is pre-assembled
under the monitor stand at delivery.

Let the machine stay with the ACDC-unit in


power on mode over night in order to charge
the batteries.

Replacement of the lead acid batteries must be


done according to following electrical diagram.

Both lead acid batteries must be changed at the


same time and only batteries approved or
supplied by Gambro Lundia AB may be used.

Changed batteries must be recycled or disposed


of properly.

Fuse: T15 A
Running time: 30 minutes

The charge indicator on the power supply is lit


when the AK 95 S is equipped with the back-up
battery. The machine must be connected to
mains voltage and the mains switch must be on.

In a mains failure situation following attention


will be given.

POWER FAILURE, BATTERY OPERATION


Battery operated for x minutes

Before the battery is empty following attention


will be given.

LOW BATTERY POWER


Machine turnes off in one minute

1:8 AK 95 / AK 95 S Service Manual


HCEN 9133 Rev. 01. 2004

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Installation Guide

Turn on the AK 95 S Recommended start-up


The ON/OFF button on the Operators Panel is
used to turn the machine on and off.
procedure
The ON/OFF button must be pressed at least 3 First check:
sec. in order to switch the machine on and off.
• That the 9V battery is connected.
The main switch on the power supply should
always be in ON position, even when the • That the mains cable is connected to power.
machine is not in use. This “Stand by” mode is
indicated by a lit segment on the TIME display • That the main switch on the rear of the
on the operators panel. monitor is turned on.

• That the machine is connected to the water


h.min
supply.
Time

• That the drain tube is properly connected to


the machine and placed with an air gap between
If a power failure occurs when AK 95 S is work- the drain tube and the drain.
ing, the same segment in the TIME display is
flashing. • That the dialysis fluid tubes are connected to
the safety couplings.
h.min
Time Start the machine

1. Press the ON/OFF button for 3 seconds.


For further information about operating
instructions, please see: 2. Perform a Heat disinfection procedure accord-
AK 95 S Operator's Manual, HCEN 9794 ing to the Operator’s Manual.
or
AK 95 Operator's Manual, HCEN 9542. 3. Perform a complete functional check accord-
ing to the Operator’s Manual.

Functional check - Fch


Each time the AK 95 is started, the automatic
functional check, Fch, is carried out.

The functional check will be aborted if Rinse/


Drain or any of the disinfection modes are
selected.

AK 95 / AK 95 S Service Manual
1:9
HCEN 9133 Rev. 01. 2004

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Installation Guide

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1:10 AK 95 / AK 95 S Service Manual


HCEN 9133 Rev. 01. 2004

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Installation Guide

Checklist - Check if applicable

Yes Unpacking and inspection Connection to the Power Supply


Ensure that the specified equipment Ensure that the voltage specified on the
has been delivered. voltage tag matches the mains voltage.

Check that the additional package box Ensure that the machine is correctly
contains the specified components. connected to the Power Supply.
Mains power must be connected to a
Check, by visual inspection that the grounded power socket.
machine shows no sign of damage.
Connection of the Battery
Environment and Physical Data Ensure that the rechargeable 9V battery is
Ensure that the Operating Environment correctly connected according to the instruc-
is according to the specifications. tions.

Interconnection Connection of the dialysis fluid tubes


Ensure that the monitors are intercon- Ensure that the dialysis fluid tubes are
nected correctly. connected to the safety couplings.
Checklist - filed by the Sevice Engi-
neer responsible for the installation.

Top Tray Start-up procedure


Ensure that the top tray is placed at Ensure that the recommended
the top of the machine. start-up procedure is followed.

Connection to the Water Supply Out of box report


Ensure that the machine is correctly Fill out the Installation / Out of
connected to the Water Supply. Box report and return it to:

Gambro Lundia AB
Ensure that the water fulfils all require- Monitor Division
ments set out under Environment and Magistratsvägen 16
Physical Data. PO Box 10101
SE-220 10 Lund
Ensure that the machine is correctly Sweden
connected to the drain.

Note! If you have any remarks during installa-


tion, please contact your Gambro Service
representative.

This record is to be signed and filed by the Service Engineer responsible for the installation.

Date............................Signature........................................................................

Serial number: ..................................

AK 95 / AK 95 S Service Manual
1:11
HCEN 9133 Rev. 01. 2004

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Installation Guide

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1:12 AK 95 / AK 95 S Service Manual


HCEN 9133 Rev. 01. 2004

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HCEN9133 © Gambro Lundia AB,1996. Revision January 2004

Gambro Lundia AB, Monitor Division


Box 10101
SE-220 10 Lund
Sweden

Tel: +46 46 16 90 00
Fax: +46 46 16 96 96
www.gambro.com

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Technical Description

2. Technical Description

Contents
Introduction Blood Part
General ........................................................ 2:2 Blood Flow Diagram ................................. 2:17
Protective system: .................................. 2:2 Treatment .................................................. 2:18
System and Treatment Parameters ........... 2:3 Component Description ............................ 2:19
Fluid Part Arterial pressure guard ....................... 2:21
Blood pump unit .................................. 2:21
Flow Diagram .............................................. 2:4
Heparin pump ...................................... 2:21
Valves .......................................................... 2:4
Venous pressure transducer ................ 2:21
Flow Diagram with Service Variables ........ 2:5
Arterial pressure transducer (option) . 2:21
Flow Diagram with Service Variables ........ 2:6
Air detector .......................................... 2:21
Treatment .................................................... 2:7
Priming detector .................................. 2:21
Fluid part: .............................................. 2:8
Operators panel ......................................... 2:22
MM 95: ................................................... 2:9
BPM ........................................................... 2:23
Fluid part, continue: ............................ 2:11
Disinfection and rinse ............................... 2:13 Power Supply
Heat disinfection .................................. 2:13 Design ........................................................ 2:24
Component Description ............................ 2:14 Block Diagram Description ....................... 2:25
Relayboard ........................................... 2:14
Pressure regulator ............................... 2:14
Conductivity measuring unit .............. 2:14
Degassing chamber .............................. 2:14
Deairating chamber ............................. 2:14
Flow pump unit .................................... 2:14
Dialyzer connections ............................ 2:14
Safety coupling unit ............................. 2:14
UF measuring unit .............................. 2:14
FM I/O board ........................................ 2:14
Heater unit ........................................... 2:14
Blood leak detector .............................. 2:15
Suction pump ....................................... 2:15
Distribution board ............................... 2:15
CPU board ............................................ 2:15
Battery ................................................. 2:15
Expansion board .................................. 2:15
Prom module board .............................. 2:15
Fan ........................................................ 2:15
Driver board ......................................... 2:15
Rear printed circuit boards ....................... 2:16

AK 95 / AK 95 S Service Manual 2:1


HCEN 9134 Rev. 10.2005

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Technical Description

Introduction
General
The AK 95 S is designed to be used as a single AK 95 S operates in either acetate- or
patient machine to perform conventional hemo- bicarbonate mode. In bicarbonate mode the
dialysis. The AK 95 S can be divided into three monitor mixes dialysis fluid from water and two
parts: concentrates: acid and bicarbonate. The mode is
selected from the operator's panel.
• Blood part
• Fluid part A disinfection must be performed after every
• Operators panel treatment. Both heat disinfection and chemical
disinfection are available.
The blood part is used to control and monitor
the extra corporeal blood flow through the The power supply supplies the AK 95 S with the
dialyzer and, where applicable, to control the necessary supply voltages. The mains voltage is
addition of heparin to the blood before dialysis. also used to supply the heater within the AK 95
Both Single needle and Double needle treatment S.
are carried out with one blood pump.
Disposable blood lines are used for the blood The AK 95 S is operated from the operators
flow. The blood part includes the following main panel located on the blood part. The panel has
functions: an overlay translated into different languages.

• Blood flow regulation For information about the use and function of
• Venous blood pressure monitoring the panel, see the document AK 95 Operators
• Arterial pressure monitoring Manual, HCEN 9542 or AK 95 S Operators
• Heparin flow regulation Manual, HCEN 9794.
• Air detection
• Priming detector Protective system
• Arterial and venous line clamps control AK 95 S is equiped with a protective system.
The main task is to supervise the dialyzing
The fluid part is used to produce dialysis fluid process and if needed take correct action to
(with the correct temperature and correct prevent hazard to the patient. The protective
conductivity) from water and concentrate, and to system can take actions independently of the
transport the fluid through the dialyzer. control system. It is a separate system, with its
own sensors and electronics.
The fluid part maintains the dialysis flow
through the dialyzer with controlled ultrafilt- Protective system is responsible for setting the
ration. AK 95 S in a patient safe state when any of the
If a fault occurs, the fluid part bypasses the supervised parameters exceed their approved
dialyzer. limits.
AK 95 S fluid part includes the following main The control system has to start up the AK 95 S
functions: in a controlled way when the hazardous situa-
tion is cleared.
• Inlet pressure monitoring.
• Temperature monitoring and regulation. The kind of action that is to be taken depends of
• Conductivity monitoring and regulation. in which state the AK 95 S is, for example
• Degassing pressure and flow regulation. treatment or disinfection.
• UF measuring and regulation.
• High pressure monitoring. Another task of protective system is to make a
• TMP monitoring. function check of AK 95 S sub systems.
• Blood leak detection.
• pH meassurement of the fluid, optional. The protective system of AK 95 S is separated in
two parts, the blood part and the fluid part.

2:2 AK 95 / AK 95 S Service Manual


HCEN 9134 Rev. 10.2005

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Technical Description

System and Treatment


Parameters
The system and treatment parameters can be
set at five different levels (table 1).

Level Type of parameters Adjustable by...

4 Treatment parameters Operator, nurse

3 Alarm limits and Clinics technician


defaults

2 Clinic or customer Gambro technician or


adaptions Gambro subsidiary

1 Market adaptions Gambro Head office

0 Safety limits Fixed

Table 1. System and Treatment parameters

For information about the use and functions of


the parameters in level 2 and 3, see the chapter
Technicians Guide.

For information about the use and functions of


the parameters in level 4, see B
A Acetate
AK 95 Operators Manual, HCEN 9542 or
AK 95 S Operators Manual, HCEN 9794.

1002

Figure 1. AK 95 S.

AK 95 / AK 95 S Service Manual 2:3


HCEN 9134 Rev. 10.2005

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Technical Description

Fluid Part
Flow Diagram

B, Ac B MM 95 Bi-
Cart
Mixing Chamber Mixing Chamber
Feeding
A Pumps Cond. Cond.
Cell "A" Cell "B"
A
FLVA
T T
Fluid connector
detection pH-SENSOR
(Optional)
RIVA
Safety by-pass SAGS Degassing
Unit
P DRVA pressure
Expansion
M chamber transducer
REVA
P
INPS P Heater T Degassing
Chamber
Water
Inlet Pressure PR 2 INVA Flow Draining Flow
regulator Restrictor Restrictor Pump
Flow
PR 1 °C switch
AIVA
Cond.
Suction Cell ”P”
Heat
exchanger Pump
ZEVA T
Drain
HPG
Blood Leak
Outlet P
Detector
Restrictor
EVVA
Draining UF-measuring
Restrictor Cell
2 1
Level
Detector Deairating
Chamber
Pressure P
Dialysis
(PD) TAVA BYVA
DIVA

Particle
Flow diagram Filter

AK 95 S Dialyzer

Figure 2. AK 95 S Flow Diagram, Bicarbonate/BiCart

Valves BYVA Bypass valve


INVA Inlet valve TAVA Taration (UF) valve
DRVA Degass restrictor valve EVVA Evacuation valve
RIVA Rinse valve AIVA Air inlet valve
ZEVA Zero (UF) valve REVA Recirculation valve
DIVA Direct valve FLVA Flush (BCH) valve

2:4 AK 95 / AK 95 S Service Manual


HCEN 9134 Rev. 10.2005

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Rel. pump speed, BiC:SRI(26),
Rel. pump speed, Ac: SRI(27)
MM 95

HCEN 9134 Rev. 10.2005


B, Ac SRL(36) B Bi-
Cart
Mixing Chamber Mixing Chamber
Feeding

AK 95 / AK 95 S Service Manual
A Pumps Cond. Cond.
SRL(35)
Cell "A" Cell "B"
A
SRL(7) = TRUE (Both connectors in the safety by-pass unit)
SRI(20) FLVA SRI(24) SRI(15) SRL(19)
SRL(8) = TRUE (Both connectors NOT in the safety by-pass unit) Rel. pump speed: SRI(22) T T (TRUE = Open)
SRL(18)
Fluid connector SRI(14)
detection pH-SENSOR

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(Optional)
RIVA SRL(21)
Safety by-pass SAGS SRI(31) SRI (59)* Degassing
P SRL(9) pressure
Unit DRVA Expansion
SAGS activated = TRUE M chamber transducer
SRL(33) REVA Treg SRI(13) *only active for machines
SRL(16) with variable flow P SRI(34)
INPS P (Pressure within Heater T Degassing
limits) Chamber
SRL(4)
Water Energized = TRUE
Inlet Pressure PR 2 INVA Flow Draining Flow
SRL(17) Heater duty cycle: SRI(11) Restrictor Pump Duty cycle: SRI(33)
regulator Flow Restrictor
(Inlet open) Current: SRI(32)
PR 1 °C switch SRL(3)
AIVA Flow = TRUE
SRL(34) Cond.
Suction Cell ”P” SRP(3)
Heat
Pump SRL(32)
exchanger ZEVA T SRP(2)
Drain SRI(53)
HPG SRI (17), Pressure
Blood Leak P SRL(23), Alarm
Outlet
Current: SRI(54) SRL(31) Detector
Restrictor
Duty cycle: SRI(55) EVVA
Draining UF-measuring
Restrictor Cell Taration timer:
UF-rate 2 1 SRI(39)
Level SRI(18) SRR(0) SRR(2) SRR(1)
Detector Deairating 0 = High
Chamber 1 = Mid
Pressure P 2 = Low
Dialysis
TMP (PD) SRL(24)
TAVA BYVA
SRP(1) SRP(4) SRL(27) DIVA
SRL(30)

Particle
Filter
Flow diagram
AK 95 S Dialyzer
Technical Description

2:5
2:6
Rel. pump speed, BiC:SRI(26),
Rel. pump speed, Ac: SRI(27)
B, Ac SRL(36) B MM 95 Bi-
Cart
Mixing Chamber Mixing Chamber
Feeding
A Pumps Cond. Cond.
SRL(35)
Cell "A" Cell "B"
Technical Description

A
SRL(7) = TRUE (Both connectors in the safety by-pass unit)
SRI(20) FLVA SRI(24) SRI(15) SRL(19)
SRL(8) = TRUE (Both connectors NOT in the safety by-pass unit) Rel. pump speed: SRI(22) T T (TRUE = Open)
SRL(18)
Fluid connector SRI(14)
detection pH-SENSOR
(Optional)
RIVA SRL(21)

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Safety by-pass SAGS SRI(31) SRI (59)* Degassing
P SRL(9) DRVA pressure
Unit Expansion
SAGS activated = TRUE M chamber transducer
SRL(33) REVA Treg SRI(13)
SRL(16) P SRI(34)
INPS P (Pressure within Heater T *only active for machines Degassing
limits) Chamber
with variable flow
SRL(4)
Water Energized = TRUE
Inlet Pressure PR 2 INVA Flow Draining Flow
SRL(17) Heater duty cycle: SRI(11) Restrictor Pump Duty cycle: SRI(33)
regulator Flow Restrictor
(Inlet open) Current: SRI(32)
PR 1 °C switch SRL(3)
AIVA Flow = TRUE
SRL(34) Cond.
Suction Cell ”P” SRP(3)
Heat
Pump SRL(32)
exchanger ZEVA T SRP(2)
Drain SRI(53)
HPG SRI (17), Pressure
Blood Leak
Outlet P SRL(23), Alarm
Current: SRI(54) SRL(31) Detector
Restrictor
Duty cycle: SRI(55) EVVA UF-measuring
Draining
Restrictor Cell Taration timer:
UF-rate 2 1 SRI(39)
Level SRI(18) SRR(0) SRR(2) SRR(1)
Detector Deairating 0 = High
Chamber 1 = Mid
Pressure P 2 = Low
Dialysis
TMP (PD) SRL(24)
TAVA BYVA
SRP(1) SRP(4) SRL(27) DIVA
SRL(30)

Particle
Filter
Flow diagram FIVA
SRL(56)
AK 95 S, UFD Dialyzer Ultrafilter
U 8000 S

HCEN 9134 Rev. 10.2005


AK 95 / AK 95 S Service Manual
Technical Description

Treatment
Fluid part:
This technical description of the AK 95 S is The TReg transducer is used in the fast tempera-
based on the flow diagram on page 2:5. ture control loop. The set value for the loop is the
set value entered by the user adjusted for the
Water is taken in through a pressure regulator, measured temperature drop to the conductivity
PR 1, and a heat exchanger, before entering cell B.
the AK 95 S fluid-unit. The pressure regulator is The temperature drop is calculated when the
set to approximately 600 mmHg, measured after temperature measured at cond.cell B is stable.
the heat exchanger. The temperature considers to be stable when it
has been in a window of ± 0.25 °C for one minute
The inlet pressure switch, INPS, detects too or more.
low pressure. If the inlet pressure is too low (less
than +99 mmHg), the inlet valve, INVA, is The function of the flow switch is to sense if
closed, the heater is switched off and the there is fluid flow or not through the heater.
AK 95 S enters the fluid bypass mode. An atten- If the flow switch does not detect flow, the
tion will be given when the pressure is too low. heater will be switched off in order to protect the
heater from overheating.
The inlet pressure should be constant, but
normally there are small fluctuations. The There is a temperature transducer in each
second pressure regulator, PR 2, is used to conductivity cell, used for compensating the
ensure a constant pressure, approximately conductivity calculation.
+130 mmHg. Normaly during treatment INVA
is open.

The main function of the temperature transduc-


ers in the AK 95 S is to measure the dialysis
fluid temperature and control the heat regula-
tion. The regulating temperature transducer,
TReg, is located after the heater.

AK 95 / AK 95 S Service Manual 2:7


HCEN 9134 Rev. 10.2005

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Technical Description

Pressure regulator, PR2

Heater
Conductivity cell P
Heater/
Flow switch
AIVA
REVA
INVA
Flow pump
RIVA

BYVA
DIVA FM I/O board
ZEVA
TAVA UF-measuring cell

EVVA Suction pump

Blood leak detector


Expansion chamber

Degassing chamber

Deairating chamber

Variable flow unit


(Stepper motor)

Line clamp unit

Clamp house
Dialyzer connection

Figure 3. AK 95 S - Fluid part

2:8 AK 95 / AK 95 S Service Manual


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Technical Description

MM 95:
The concentrate connectors are connected to the bicarbonate/water mixture goes through the
water flow path by self-sealing valves. second mixing chamber, to prevent air from
The heated water flows through the feeding causing unstable conductivity readings, before
pumps. The pumps are ceramic, and need a entering the B- conductivity cell. The meas-
constant flow of water through the pump ele- urement from the B-cell is compared with the
ment; this acts as a lubricant. required conductivity and any difference be-
tween the two will result in a change of the
In Bicarbonate mode the acid concentrate is B-pump speed to correct the difference. There is
taken up through the red A-concentrate connec- a temperature transducer in the B-conductivity
tor by the A-pump and added to the water flow. cell to compensate the conductivity calculation
The acid/water mixture goes through a mixing since it varies with temperature, approximately
chamber, to prevent air from causing unstable +1,8 % per °C.
conductivity readings, before entering the A-
conductivity cell. The measurement from the When BiCart® is mounted, the flushing valve,
A-cell is compared with the required conductiv- FLVA, is used for priming of the BiCart car-
ity and any difference between the two will tridge. FLVA is also used during fill up of di-
result in a change of the A-pump speed to correct luted chemical disinfection solution.
the difference. There is a temperature trans-
ducer in the conductivity cell to compensate the Note that in acetate mode the A conductivity cell
conductivity calculation since it varies with and A pump are not used. The acetate concen-
temperature, approximately +1,8 % per °C. trate is taken up through the blue B-concentrate
connector.
The bicarbonate concentrate is taken up through
the B-concentrate connector by the B-pump and The mixed fluid is then passing the (optional)
added to the acid/water solution. The acid/ pH-sensor before leaving the MM 95.

B, Ac B MM 95 Bi-
Cart
Mixing Chamber Mixing Chamber
Feeding
A Pumps Cond.
Cell "A" Cond.Cell "B"
A
FLVA
T T
pH-SENSOR

Figure 4. MM 95 - Flow diagram

AK 95 / AK 95 S Service Manual 2:9


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Technical Description

A
Feeding
Pump
B

A
Mixing
Chambers B
Heat
Exchanger

FLVA

A
Conductivity
Cell B

Figure 5. MM 95

2:10 AK 95 / AK 95 S Service Manual


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Technical Description

Fluid part, continued: The treatment is carried out under controlled


The degassing chamber is used to separate air ultrafiltration, UF. The UF- volume is a meas-
from the dialysis fluid. A negative pressure is ure of the ultrafiltrate. The differential flow is
created by means of the flow restrictor to- measured in the UF measuring cell. The
gether with the flow pump. This degassing required UF-rate is selected by setting the
pressure is presettable between -400 mmHg and treatment time and the UF-volume. The actual
-700 mmHg, to adjust the degassing on high UF-rate is compared with the required UF-rate
altitudes. and the suction pump is regulated so that the
desired UF-rate is obtained. If the actual value
The air expands in the expansion chamber. A is lower than the required value, the suction
draining restrictor is integrated in the botton pump will run faster. When the operator adjusts
of the expansion chamber. the UF- volume or treatment time, the system
automatically calculates the UF-rate.
The degassing pressure transducer, which
measures the negative pressure, is used to Every 30 minutes during treatment, the UF-cell
control the flow pump in order to ensure the is automatically self-calibrated. This is called a
correct degassing pressure. The air bubbles are taration. This has to be done because waste
separated in the degassing chamber. When the products in the fluid returned from the dialyzer
fluid level in the degassing chamber reaches the will be deposited in layers on the inside of the
minimum level depending on increased air measuring channel 2. The taration can be
pressure, the float valve in the degassing cham- divided into two phases:
ber is opened and the air is led from the
degassing chamber to the drain via the suction Phase 1: Offset (Zerosetting) phase. The UF
pump. When the fluid level in the degassing measuring cell and the dialyzer are “discon-
chamber reaches the maximum level, the float nected”, i.e. there is no fluid passing through
valve is closed. The dialysis fluid is taken out in neither of the two channels in the UF cell. The
the bottom of the degassing chamber. The offset of the two measurement channels can now
rinsing valve, RIVA, is closed during treatment. be measured.
During disinfection the rinsing valve is open, in
order to fill the degassing chamber completely. During this phase the DIVA, BYVA and TAVA
valves are closed and the ZEVA valve is open.
The pressure in the flow path is controlled by
the suctionpump. The HPG-pressure is used and
the set value is the pressure measured just
before start of the self-calibration.

Phase 2: Coefficient (flow deviation) phase. The


dialysis fluid is led past the dialyzer but through
the UF unit, i.e. the same amount of fluid is
Figure 6. Flow pump and degassing chamber passing through both channels of the UF cell.
The DIVA, TAVA and ZEVA valves are closed
The flow restrictor is also used to control the and the BYVA valve is open. The calibration
main flow in the system. The main flow is vari- coefficient of channel 2 can now be calculated,
able between 300-700 ml/min in steps of 20 ml/ channel 1 is reference.
min. The degassing restrictor valve, DRVA, is
regulated to achieve correct flow. During disin- The taration takes totally about 60 seconds.
fection and rinse this valve is completely open. When the taration is completed, the treatment is
resumed.
The third conductivity cell, Cond.Cell P, is only
used for the protective system. Before the UF measuring cell there is a pres-
There is a temperature transducer in the con- sure transducer, HPG (high pressure guard).
ductivity cell to compensate the conductivity INVA is closed if the pressure measured by the
calculation since it varies with temperature, HPG transducer is above or equal to +550 mmHg
approximately +1,8 % per °C. (presetable).

AK 95 / AK 95 S Service Manual 2:11


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Technical Description

For example, if there is a blockage somewhere in


the tubes, the HPG generates an alarm and the
AK 95 S enters the bypass mode. The dialysis fluid is led through channel 2 of the
UF measuring cell to the blood leak detector.
Treg after the heater is used together with the The blood leak detector detects any blood in the
temperature transducer on conductivity cell B, fluid. In the event of leak between the blood side
to control the heater. and dialysis fluid side of the dialyzer, an alarm
will be activated and the machine enters the
The bypass unit includes two valves: bypass mode.
The direct valve, DIVA, is normally open during
treatment (if the temperature, pressure, conduc- Most of the dialysis fluid (90 to 95%) is taken out
tivity etc. are within the predefined limits). at the top of the blood leak detector. The rest is
The direct valve is closed and the bypass valve, let out via a drain restrictor. The reason for
BYVA, is opened when the dialysis fluid is this is that the blood leak detector has to be
bypassed from the dialyzer. The dialysis fluid is completely emptied during drain phase.
led past the dialyzer directly to the drain.
Finally, the dialysis fluid is led to the drain, via
The dialysis fluid is forwarded to the dialyzer the suction pump, the outlet restrictor and
via the output tube. the drain-tube.

From the dialyzer the dialysis fluid (mixed with


waste products) is returned to the fluid unit via
the input tube. The input tube nipple is fitted
with a filter.

The Dialysis fluid pressure transducer, PD,


after the dialyzer measures the dialysis fluid
pressure. This pressure transducer is the most
important pressure transducer in the system.
PD is used for calculation of the transmembrane
pressure, TMP.

TMP is calculated by the system and presented


on the operators panel. If the TMP is not within
the predefined limits, an alarm is issued.

The dialysis fluid is fed to a deairating cham-


ber, which is used to separate air from the fluid.
For example, a leakage may occur in the dialyzer
connection. It is important that the air bubbles
are separated from the dialysis fluid, otherwise
the UF measuring could be affected. When the
fluid level in the deairating chamber reaches the
minimum level, i.e. when there is too much air
in the deairating chamber, the evacuation valve,
EVVA, is opened and the air is released. When
the fluid level reaches over the minimum level,
the evacuation valve is closed and so on. The
“degassed” fluid is taken out in the bottom of the
deairating chamber.
The taration valve, TAVA, is normally open
during treatment. During calibration of the UF
measuring unit, the taration valve is closed.
TAVA is also closed when the protective system
demands a minimum of UF.

2:12 AK 95 / AK 95 S Service Manual


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Technical Description

Disinfection and rinse


Chem disinfection Heat disinfection is selected with the HEAT
DISINF button. The remaining disinfection
When Disinfection is selected by pressing the
time shows on the time display as soon the
CHEM DISINF key, the information display
disinfection starts. How many minutes a pro-
will show three alternatives of disinfection
gram lasts is seen below. Total time for Disinfec-
solutions.
tion Programs are estimated and may vary.
The disinfectant fluid will be taken up by the B- Disinfection programs Time [min]
tube and if the B tube is not taken out of the
machine and/or if the A-tube is taken out, there
230 V 110 V 100 V
will be an attention.
With UFD installed
When the filling phase is finished the AK 95 S Heat 35 39 49
will give an attention that requests you to place
the B-tube back in the monitor. When this is Heat Citric acid 20% 52 57 67
done the disinfection solution is distributed in all Heat CleanCart 49 54 64
of the fluid path and the dwell time starts. As
Without UFD
soon as the dwell time is done, an automatic
rinse will start. Heat 33 37 47
Heat Citric acid 20% 50 55 65
It is possible to end the Disinfection dwell
program before it is finished by pressing Heat CleanCart 46 51 61
RINSE/DRAIN key.
Four minutes before completion of the heat-
It is not possible to go from chemical disinfection disinfection, the program enters the drain phase
mode to treatment mode without a rinse. In case and the heat disinfection lamp is turned off. The
of a power failure the monitor will save recovery heat disinfection completes when the RINSE/
data and continue the disinfection when the DRAIN key is flashing.
power returns.
When pressing the flashing RINSE/DRAIN key
after a completed disinfection, the machine will
perform a functional check (Fch).
Heat disinfection
During the heat disinfection program the inlet
water is heated and rinsed through the fluid Rinse/Drain
unit. The machine is then drained. Rinse mode will be started automatically after a
It is also possible to run the heat disinfection in disinfection as described above or manually by
combination with Citric Acid 20% or with a pressing the RINSE/DRAIN key. The display
CleanCart installed. shows the rinse time and allows you to change it
if you wish. The rinse program will run for the
For heat disinfection a heat exchanger is a set time. Both A- and B- pick-up tubes must be
requirement. For 230V version the exchanger placed in the monitor, otherwise there will be an
must have an efficiency of minimum 60%. 110V attention. During the final drain phase the air
and 100 V requires 76% efficiency. intake valve, AIVA, is open. When rinse is
To get a proper heat disinfection, the fluid must completed the RINSE/DRAIN key will be flash-
exceed 80°C. The exchanger is not only necessar- ing.
ily to achieve proper temperature but it is also The machine will perform a functional check
important for stabilization of the heater control (Fch), when pressing the flashing RINSE/
system. DRAIN key after a completed disinfection.

There is a possibility to reset and preset the


chemical disinfection mode by enter the service
mode. For more information, see chapter 4,
Technicians guide.

AK 95 / AK 95 S Service Manual 2:13


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Technical Description

Component Description
Heater relay board Dialyzer connections
The heater relay board comprises the following: The input tube nipple is fitted with a particle
• Opto relay filter.
• Heater safety relay
• Heater sensor (“energized”) Safety coupling unit
The safety coupling unit comprises two tube
Pressure regulator, PR 2 connections, which are used when the machine
The pressure regulator is adjusted to give cor- is to be disinfected, and a pressostate SAGS,
rect pressure (approx.. +130 mmHg). which detects when the tubes are disconnected
from the safety coupling.
Conductivity measuring unit The AK 95 S is also equipped with a pair of
mechanical switches that sense if the dia connec-
The unit includes the following components:
tors are attached to the bypass block.
• Measuring cell.
• Conductivity board, which is mounted
directly on the measuring cell. The con- UF measuring unit
ductivity board interfaces to the CPU The UF measuring unit consists of the following
board, via a board connector and a flat components:
cable. • Measuring cell.
• Temperature transducer. • UF amplifier board.
• UF driver board.
Degassing chamber
The boards are mounted on each side of the
The AK 95 S contains one degassing chamber
measuring cell. The UF measuring unit inter-
used to separate air from the dialysis fluid.
faces to the Control Driver, via the UF amplifier
The degassing chamber comprises a mechanical
board, a board connector and a flat cable.
float valve.

Mixing chambers FM I/O board


The FM I/O board contains of 6 connectors to
The AK 95 S contains two mixing chambers used
pressure transducers and temp. transducers. It
to mix the concentrate with the water and
also contains the running time meter.
separate air from the dialysis fluid before enter-
ing the conductivity cell.
Heater unit
Deairating chamber The heater is connected to the relay board, via a
cable. It comprises a temperaturetransducer
The deairating chamber comprises a level
TReg. The transducer is connected to a transducer
detector and the dialysis fluid pressure trans-
board, via a twisted cable. The transducer board
ducer. The level detector interfaces to the FM I/
interfaces directly to the
O board, via a cable. The pressure transducer is
FM I/O board, via a board connector.
connected to a pressure transducer board, via a
twisted cable. The pressure transducer board
NOTE! If the heater cartridge has been over-
interfaces directly to the FM I/O board.
heated, this must be exchanged and the leakage
current to earth measured before restart.
Flow pump unit
The flow pump unit consists of the following: Flow Switch
• Gearwheel pump driven by a DC-
A mechanical flow switch is mounted before the
motor.
heater. The flow switch will turn off the heater
• Pressure transducer with board. The
in a no-flow situation.
pressure transducer is connected to the
transducer board, via a twisted cable. The
transducer board interfaces directly to the
FM I/O board, via a board connector.

2:14 AK 95 / AK 95 S Service Manual


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Technical Description

Blood leak detector CPU board


The blood leak detector includes the following AK 95 S is equipped with one Control CPU board
components: and one Protective CPU board.
• Housing with cover. The CPU boards comprises among other things
• Transmitter and Receiverboard the microcomputers. The spare parts list gives
• Blood leak detector board. the board connectors which reside on the CPU
boards.
The transmitter and receiver boards are con-
nected to the blood leak detector board, via
twisted cables. The blood leak detector board Battery
interfaces directly to the FM I/O board, via a The battery is a rechargeable 9V battery. The
board connector. battery is used to drive the buzzer alarm during
mains power failure. The battery is not con-
nected at delivery.
Suction pump
The suction pump consists of a gearwheel pump
NOTE! The battery must be connected during
driven by a DC-motor.
the installation according to the instruction in
the Installations Guide.
MM I/O board
The MM I/O board is mounted in the mixing Fan
module. It transfers control and data informa-
The drive motor (DC-motor) and the fan form a
tion received from the CPU boards to the various
single unit. The fan is connected to the driver
electronic and electromechanical parts in the
board, via a cable.
mixing module. It also transmits sensor informa-
tion from the mixing module up to the CPU
boards in the AK 95 S. Driver board
AK 95 S is equiped with one Control Driver
board and one Protective Driver board, according
to the figure 8.

AK 95 / AK 95 S Service Manual 2:15


HCEN 9134 Rev. 10.2005

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Technical Description

Rear printed circuit boards

er
Protective Driv
boar d Contr
ol
board Driver

CPU
Protective Cont
ro
board boar l CPU
d

Figure 8 . AK 95 S CPU-boards and Driver boards.

2:16 AK 95 / AK 95 S Service Manual


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Technical Description

Blood Part
Blood Flow Diagram

Arterial pressure
P transducer (optional)
Arterial line
clamp
Arterial
pressure guard
Arterial blood
pump
Arterial blood
line

Patient Heparin pump Dialyzer

Venous blood
line
Venous drip
chamber
Priming
detector Air detector
Venous line
clamp
P

Venous pressure
transducer

Figure 9. AK 95 S - Blood Flow Diagram.

AK 95 / AK 95 S Service Manual 2:17


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Technical Description

Treatment
Arterial blood is taken in via the arterial line If the venous pressure is too low, the cause may
clamp. During treatment the line clamp is open. be:

The arterial pressure guard is used to give an • A line separation.


alarm if the pressure becomes too low. For • A drop in blood pressure.
example, if the needle or the arterial blood line • A change in the patients position.
is blocked, an alarm will be given ( the blood
pump is stopped). The alarm is activated if there
is an increased negative pressure between the The air detector has the following function:
patient and the blood pump,e.g: If the blood level in the venous drip chamber
is too low, an alarm is given and the blood flow is
• A drop in blood pressure. stopped (the blood pump and heparin pump are
• Altered positions of the arterial needle. stopped and the venous line clamp is closed). The
• A kink in the arterial line between the venous drip chamber acts as an expansion cham-
patient and the blood pump. ber to even out pressure pulsations.
When the air detection alarm is generated, the
The function of the blood pump is to maintain lamp in the Air detect button is lit and the
the extra corporeal blood flow. Blood is removed buzzer sounds. The lamp begins flashing when
from the patient, forwarded to the dialyzer and the air detector does not detect air any longer.
then returned to the patient. The operator must reset the air detection alarm
The blood pump can not be run when the pump by pressing the Air detect button. After press-
cover is open. ing the Air detect button for 3 seconds, the air
detector alarm is bypassed for x seconds (preset-
If necessary, the blood can be returned to the table 0-120 sec.). Default it is disabled (0 sec-
patient manually. onds) and no override is possible.

The purpose of the heparin pump is to add


heparin to the blood. The priming detector detects if there is blood
An alarm is issued when the syringe is empty or in the venous blood line. If no blood is detected,
if the heparin line is kinked. it is not possible to start the treatment.
The heparin parameters can be adjusted by
pressing the heparin button.
The blood is transported back to the patient via
The venous pressure transducer measures the venous line clamp. The clamp is normally
the venous bloodpressure. The lamp in the open. But in the event of an alarm from the air
Venous pressure button is lit and the buzzer detector or the venous pressure transducer, the
sounds if the alarms are activated and the line clamp clamps the blood line and stops the
venous bloodpressure is outside the alarm blood flow (not during high pressure alarm).
limits. If the event of an alarm, the blood flow is
stopped.
If the venous pressure is too high, the cause may
be:

• An obstruction after the venous drip


chamber.
• A change in the patients position.

2:18 AK 95 / AK 95 S Service Manual


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Technical Description

Component Description

3 4
5
7 2

1076

Figure 10. AK 95 S Blood part - Outside components

1. Operators panel
2. Air detector
3. Venous pressure transducer
4. Arterial pressure transducer
5. Blood pump unit
6. Heparin pump unit
7. Expansion chamber holder

AK 95 / AK 95 S Service Manual 2:19


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Technical Description

Figure 11 . AK 95 S Blood part - Inside components

1. Operators panel
2. Air detector
3. Venous pressure transducer
4. Arterial pressure transducer
5. Blood pump unit
6. Heparin pump unit
7. Expansion chamber holder
8. BM I/O Board
9. Level regulation

2:20 AK 95 / AK 95 S Service Manual


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Technical Description

Line clamps Venous pressure transducer (C+P)


The blood unit includes two line clamps: Arterial The blood unit is equipped with two pressure
line clamp and venous line clamp. The arterial transducers connected to one port, which are
line clamp is located to the right and the venous used to measure the venous blood pressure. The
line clamp is located to the left when viewed pressure transducers are mounted on a pressure
from the front. The clamp covers also have transducer board, which interfaces directly to
different colour markings: The arterial clamp the BM I/O board, via a board connector. The
cover is marked with a red dot and the venous pressure transducers are connected to the
clamp cover is marked with a blue dot. venous pressure transducer nipple (located on
The line clamp unit consists of the following: the front), via a small tube.

• Housing with covers (mounted on the front


Arterial pressure transducer
plate).
• 2 solenoids (as one unit). AK 95 S can be equipped with a second pressure
• Line clamp driver board. transducer, named Arterial Pressure Trans-
• 2 clamp detectors. ducer. This pressure will be displayed on the
arterial bargraph. The transducer is used for
The line clamp driver board interfaces to the true arterial pressure measurement or any other
protective CPU board, via a board connector and pressure. The pressure transducer is mounted
a flat cable. on a pressure transducer board, which interfaces
directly to the BM I/O board, via a board connec-
tor.

Blood pump unit Air detector


The blood pump unit consists of the following: The air detector consists of an ultrasonic trans-
mitter and receiver mounted in a head. The air
• Tube pump (self-threading). detector head is adjustable to accomodate most
• 24 V bruchless DC motor with an encoder drip chambers of 18-30 mm diameter. The air
for velocity monitoring. detector interfaces to the BM I/O board and the
• Gear box (1:50). driver board via 2 cables.
• Cover detector.
Priming detector
The blood pump unit, except the tube pump, is The priming detector is intergrated in the Line
mounted on the back of the front plate. The Clamp Unit. It has a detector board (on the back
motor, cover detector and position board inter- of the front). The detector board contains a LED
face to the BM I/O board, via connectors and and a phototransistor. The current through the
cables. LED is indicating how much current that is
needed to get a certain light transmission
Heparin pump through the light guides to the receiver. The
lower the value is, the better.
The heparin pump unit consists of the following
components:

• Syringe pump. The diameter of the syr-


inge can range between 10 to 30 mm
• Stepping motor.
• Gear box (1:120).
• Heparin pump position board.
• Heparin pump feedback potentiometer.

The stepping motor, heparin pump position


board and heparin pump potentiometer interface
to the BM I/O board, via cables.

AK 95 / AK 95 S Service Manual 2:21


HCEN 9134 Rev. 10.2005

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Technical Description

Operators panel
The operators panel is a flat surface panel. It
comprises:

• 40 buttons visible and 3 hidden.


(LED luminated)
• 8 bar graph displays. (LED luminated)
• 1 alphanumerical display (LCD).
• 1 numerical display (LED).
• 2 knobs.

The panel interfaces to the protective driver-


board, via 3 board connectors and 3 flat cables.

Figure 12. Operators panel

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Technical Description

BPM
The BPM (Blood pressure monitor) is physically The relationship between the changes of cuff
placed in the MM95. pressure and its oscillation is used to determine
The BPM monitor is a passive measuring device the blood pressure. When the BPM deflates the
that can issue attentions and alarms but the cuff and the blood starts to pass the restriction,
alarms will not interfere with the the oscillation incline rapidly and the systolic
AK 95 S treatment. (high) pressure is measured. When the oscilla-
tion has peaked and is declining rapidly the dias-
The intended use for the BPM is to measure the tolic (low) pressure is measured. The mean pres-
patient’s blood pressure and to activate an alarm sure is measured when the oscillation is peaking.
if the patient’s blood pressure goes under an The heart rate is determined by using the pres-
alarm limit set by the operator. This will give sure oscillations measured by the pressure trans-
the nurses the possibility to take measures be- ducer.
fore the patient suffers the ill effects of hypoten-
sion (low blood pressure). When to measure the diastolic pressure is deter-
mined by extensive experiments to establish an
The BPM module includes the following compo- algorithm, which is included in the BPM soft-
nents; air pump, bleed valve, dump valve, pres- ware.
sure transducers (control and protective) and
microprocessor board. The module includes con- In the field it is possible to perform a check of
trol and protective systems. the device to determine if it works or not.
The device has to be sent to Gambro for repair
The control system measures the pressure and incase of malfunction.
pulse wave to calculate the systolic, diastolic,
mean blood pressure and pulse rate. The air
pump, dump and bleed valves are controlled by
this system as well as external communication.

The protective system supervises the maximum


pressure and inflating time. Maximum pressure
is 320 ± 10 mmHg and maximum inflating time
is 180 seconds. When these values exceed speci-
fied limits, dump and bleed valves are opened
and air pump is stopped by the protective sys-
tem.

A self-calibration/auto zero function is included


in the module, which means that the offset for
the pressure transducers is calibrated/adjusted
each time the module is turned on.

The BPM measures and calculates the non-inva-


sive blood pressure by using the oscillometric
method. This method uses the pulsation that
occurs in the artery in the arm when it is re-
stricted by the inflated cuff. The noise or oscilla-
tion originates from the fact that when the cuff
restricts the vessel, the flow in the vessel be-
comes turbulent, instead of laminar. The pulsa-
tion causes the pressure in the cuff to oscillate
which the pressure transducer in the BPM mod-
ule measures.

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HCEN 9134 Rev. 10.2005

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Technical Description

Power Supply
Design

Power supply to
heater relay board Power supply to
Control CPU board

External
Fuses: 12 AH T12AH
250AC

HALT

BACH BACO

Contact
Fan Intake
Mains Switch

Figure 13. AK 95 S, AC/DC-unit

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HCEN 9134 Rev. 10.2005

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Technical Description

Block Diagram Description

External fuses
12AH
12AH Filter MAINS to heater rod

Internal fuses +5VDC


AC
Filter +5VDC
DC ±12VDC
+24VDC

AC
+12VDC
DC

MAIN SWITCH
MAINS INPUT

Battery
Figure 14. Block diagram, power supply 24 V

The mains voltage is fed to an AC/DC converter The mains voltage also supplies the voltage to
which generates different DC supplies to the the heating element.
monitor.
In a mains power failure situation, the AK 95 S
•Two +5 volt supplies, one for the control system gives an intermittent buzzer alarm and performs
and the other for protective digital electronics. a recovery, when the power returns. All the
settings and accumulated values are stored in
•±12 volt is used for analog electronics. the machine. The treatment will be continued
from where it was interrupted.
•+24 volt is used for lamps, displays, blood-
pump, heparin pump, clamps, pumpmotor AK 95 S will perform a recovery when the
(flow pump, suction pump), valves, fan and the monitor is in treatment or disinfection.
heating relay. In service and preset mode the monitor will start
• The lower +12 V is a standby voltage for the with a Fch.
ON/OFF logic.

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Technical Description

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Chapter 3

Technical data and specifications


Performance and specification - Control system . . . . . . . . . . . . . . . . . 3:2
Blood flow control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:2
Heparin administration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:2
Blood pressure control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:3
Blood Pressure Monitor (BPM) . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:3
Dialysis fluid preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:4
Ultrafiltration control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:5
Profiling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:5
Disinfection and cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:5
Water supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:7
Power supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:8
Connection of external equipment . . . . . . . . . . . . . . . . . . . . . . . . . 3:9
Battery back-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:10
Performance and specification - Supervisory system . . . . . . . . . . . . . 3:11
Blood pressure supervision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:11
Extracorporeal blood loss to the environment . . . . . . . . . . . . . . . . 3:11
Air detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:11
Extracorporeal blood loss due to coagulation . . . . . . . . . . . . . . . . . 3:11
Dialysis fluid preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:12
Ultrafiltration supervision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:12
Blood leakage detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:12
pH-meter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:12
Physical data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:13
Dimensions and weight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:13
Infusion stand . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:13
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:13
Materials in contact with dialysate, concentrates and water . . . . . . . . 3:14
Environmental data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:15
Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:15
Transportation and storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:15
Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:16

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Performance and specification - Control
system
Blood flow control
Values for the blood pump(s) are based on a pressure of -150 mmHg
before the arterial blood pump with a pump segment of 7.9 mm. For
pediatric blood tubes with pump segment of 4.0 mm it is also possible
to set blood flow to 5, 10 or 15 ml/min.

Double needle

Flow rate: 0 and 20 - 500 ml/min (-150 mmHg


prepump pressure, pump segment
diameter 7.9 mm)
Flow accuracy: ±10 ml/min or ±15%, whichever is largest
Accumulated blood vol- 0 - 327 litres
ume:
Volume accuracy: ±0.6 l treatment time (h) or ±15%

Single needle

Flow rate: 0 and 20 - 500 ml/min (-150 mmHg


prepump pressure, pump segment
diameter 7.9 mm)
Flow accuracy: ±10 ml/min or ±18%, whichever is largest
Time control: 2 - 20 seconds (±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 - 500 mmHg (±50 mmHg), venous
pressure control
Accumulated blood vol- 0 to 327 litres
ume:
Volume accuracy: ±0.6 l treatment time (h) or ±18%

Heparin administration
Heparinization: 0 to 10 ml/h (±1 ml/5 h or ±5%) The
accuracy is based on tests with 20 ml and
30 ml syringes
Syringe size: Syringes shall comply with ISO 7886-2.
Upon delivery, the machine is set for a
20 ml Terumo syringe. Syringes of other
volumes and brands can be set.
Stop time: Heparinization stops before end of
treatment 0.00 to 9.59 h
Counter pressure: Maximum 400 mmHg
Accumulated heparin 0 to 999.9 ml
volume:

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Blood pressure control
Venous pressure:

Operating range -700 to 750 mmHg


Alarm limits: 10 to 500 mmHg in treatment mode, -100
to 500 mmHg in priming mode
Accuracy: -700 to -500 mmHg, ±10% -500 to 500
mmHg, ±5 mmHg or ±3%, whichever is
largest 500 to 750 mmHg, ±10%

Blood Pressure Monitor (BPM)


Systolic pressure range1 60 - 250 mmHg
Low alarm limit, can be 60 - 250 mmHg (100 mmHg)
preset (Default)
High alarm limit, can be 60 - 250 mmHg (150 mmHg)
preset (Default)
Diastolic pressure range1 40 - 200 mmHg
Low alarm limit, can be 40 - 200 mmHg (60 mmHg)
preset (Default)
High alarm limit, can be 40 - 200 mmHg (100 mmHg)
preset (Default)
Mean pressure range1 45 - 235 mmHg
Low alarm limit, can be 45 - 235 mmHg (75 mmHg)
preset (Default)
High alarm limit, can be 45 - 235 mmHg (115 mmHg)
preset (Default)
Pulse rate range 40 - 200 bpm (±2 bpm or ±2% of reading)
Low alarm limit, can be 40 - 200 bpm (40 bpm)
preset (Default)
High alarm limit, can be 40 - 200 bpm (150 bpm)
preset (Default)

1Meets ANSI/AAMI SP-10 (1992). Mean error ±5 mmHg. Standard


deviation 8 mmHg

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Dialysis fluid preparation
Pressure regulators: After pressure regulator PR 1 and the
heat exchangers:
80 kPa (0.8 ±0.1 bar)
After pressure regulator PR 2:
130 ±10 mmHg

Temperature: Adjustable 33 to 40 °C. Accuracy is


valid only if dialysis fluid temperature is
greater or equal to ambient temperature.
Alarm limits: Adjustable 33 to 40 °C
Accuracy: +0.5/-1.5 °C (+1,0/-2.5 °C with UFD-kit)
at the dialysis fluid outlet from the
machine.
Heater capacity: 1000 W (+10% / -5%) at 100 V 1300 W
(+10% / -5%) at 110 V 1750 W (+10% /
-5%) at 230 V
Overheat protection: Reg-temp 80 °C or Cond A-temp 70 °C
in treatment, software Reg-temp 99 °C
in disinfection, software. The heater can
only be on if there is a flow through the
heater. The flow is detected by a flow
switch.
Flow rate: 300-700 ml/min in steps of 20 ml/min
Accuracy: ±10% or 50 ml/min whichever is largest
Degassing: By use of negative pressure, -610 mmHg.
Adjustable degassing pressure between
-300 and -700 mmHg (-650 mmHg with
700 ml/min flow rate).
Accuracy: ±40 mmHg
Dialysis fluid pressure: -400 to +300 mmHg.
Accuracy: ±10 mmHg or ±5%
Proportioning of concen- The proportioning of concentrate is
trates: done through conductivity control. The
concentrates are pumped into the system
with one/two volume trically supervised
pumps. No minimum feeding pressure
is necessary, the fluid is sucked in.
Maximum feeding pressure, 150 kPa.
Acetate: Na+ , 130 to 160 mmol/l, (±3 mmol/l)
Bicarbonate: Na+ , 130 to 160 mmol/l, (±6
mmol/l)HCO3- , 20 to 40 mmol/l,
(±6 mmol/l)
Measuring range: 13 to 16 mS/cm
Alarm limits: ±5% of the calculated conductivity set
value

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Ultrafiltration control
Volume control: Direct electromagnetic measurement of
dialysis fluid flow, before and after the
dialyzer.
UF volume: Adjustable 0 to 10.00 l
Accuracy of measured ±50 ml/h or ±1% whichever is largest
volume:
UF coefficient: Maximum 85 ml/h/mmHg
UF rate: 0.0 to 4 l/h, given by the set values of UF
volume and treatment time.
Time: Remaining treatment time control. 0.05
to 9.59 hour. minute (±1 minute)

Profiling
UF-rate 0.0 to 4 l/h
Na+, Acetate mode 130 to 160 mmol/l
Na+, Bicarbonate mode 130 to 160 mmol/l
HCO3-, Bicarbonate mode 20 to 40 mmol/l

Disinfection and cleaning


Chemical disinfection

Peracetic Acid Program (presetable)

Concentration of disinfec- 3.5% peracetic acid


tant
Concentration in machine 0.1%, i.e. diluted 1 + 34 (1:35)
Volume approx. 85 ml (with UFD-kit approx. 92
ml)
Contact time between 10 minutes
treatments
Contact time overnight or Minimum 3h dwell time
when not in use (recom-
mended with UFD-kit)
Total time 30 minutes (with UFD-kit 59 minutes)
including 10 min. contact time

Hypochlorite Program (presetable)

Concentration of disinfec- 10% available chlorine


tant
Concentration in machine 0.5%, i.e. diluted 1 + 19 (1:20)
Volume Approx. 145 ml (with UFD-kit approx.
153 ml)
Contact time between 10 minutes
treatments
Contact time overnight or Maximum 20 min, not intended for
when not in use overnight disinfection!
Total time 30 minutes (with UFD-kit 48 minutes)
including 10 min. contact time

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Formaldehyde Program (presetable)

Concentration of disinfec- 37 % formaldehyde


tion
Concentration in machine 3.7%, i.e. diluted 1 + 9 (1:10)
Volume Approx. 275 ml (with UFD-kit approx.
290 ml)
Contact time between 20 min
treatments
Contact time overnight or Minimum 6h dwell time
when not in use (recom-
mended with UFD-kit)
Total time 119 minutes (with UFD-kit 150 minutes)
including 20 min contact time

Heat disinfection

One of three alternatives for heat disinfection can be selected. The


second alternative is presetable for a combined heating program and
the third is a CleanCart / heating alternative. The default settings are
as follows.

AK 95 S Disinfection Total Time [min]


programs
230 V 110 V 100 V
With UFD Heat 35 39 49
installed
Heat Citric acid 20 % 52 57 67
Heat CleanCart 49 54 64

Without UFD Heat 33 37 47


Heat Citric acid 20 % 50 55 65
Heat CleanCart 46 51 61

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Auto Heat disinfection

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

AK 95 S Disinfection programs Total Time [min]


230 V 110 V 100 V
With UFD Heat 31 35 45
installed
Heat CleanCart 43 49 58

Without Heat 31 35 45
UFD
Heat CleanCart 43 48 58

Temperature: +93 °C (measured after heating rod) ≥80


°C (measured in the outlet before the heat
exchanger)
Note: The temperatures are verified at nominal values for the mains
voltage and at 20 °C ambient temperature.

Rinse/Drain:

Rinse/Drain 10 minutes
Drain 4 minutes
Exterior cleaning: All outside parts of the machine can
be cleaned with ethanol (70%) or
isopropanol (60%).
Note: Total Time for Disinfection Programs are estimated and may
vary.

Water supply
Flow rate: During treatment: maximum 770
ml/minDuring disinfection and
rinse/drain: a maximum flow rate of 800
ml/min is required.
Minimum inlet pressure: 0.12 MPa (1.2 bar)
Maximum inlet pressure: 0.6 MPa (6 bar)
Inlet temperature: Treatment: +5 to +30 ºC Disinfection:
+5 to +90 ºC
Connector in/outlet: Diameter 8 mm
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.

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Drain: The drain tube outlet must be placed
between floor level and maximum 1.2
m above the outlet connection from the
fluid monitor. An air gap to atmospheric
pressure must always be arranged at the
tube outlet.
Length of drain tube: <10 m
High pressure guard ±500 mmHg, (±10 mmHg or ±5%,
transducer: whichever is largest)
Inlet pressure switch Increasing: +150 mmHg, ±20 mmHg
(INPS): Decreasing: +99 mmHg, ±20 mmHg
Safety guard switch Increasing: -59 mmHg, ±7 mmHg
(SAGS): Decreasing: -74 mmHg, ±7 mmHg

Power supply
Mains voltage: 100 V (at 50 Hz or 60 Hz) , 110 V (at 50
Hz or 60 Hz) or 230 V (at 50 Hz or 60
Hz) (∼AC), (±12%). The voltage has to
be specified before installation.
Note: The user must verify the quality of the protective earth in the
installation.

Power consumption: 2025 W at 230 V 1575 W at 110 V 1275


W at 100 V
Cable length: 3m
Cable area: AWG 14 at 100 V and 110 V 1 mm2 at
230 V
External fuses: For 100/110 V, 2 x 12 AT for heater. For
230 V, 2 x 12 AT for heater.
Mains plug: For 100/110 V, Hospital grade, earth
plug, type IEC 83 A5-15 For 230 V, Dual
earth system plug, type IEC 83 C4
Maximum earth leakage 100 µA (100 V) 125 µA (110 V) 200 µA
current: (230 V)
Maximum patient leakage 10 µA (100 V) 10 µA (110 V) 10 µA
current: (230 V)
Note: All leakage currents specified are without external equipment
connected to the AK 95 S.

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Connection of external equipment
External connector: 25 pin D-Sub with RS-232C or
RS-422/Current loop. Opto insulated
fulfilling IEC 60601-1-1.
External equipment: External equipment intended for
connection to signal input, signal output
or other connectors, shall comply with
relevant IEC standard (e.g. IEC 60950
for IT equipment and the IEC 60601
series for medical electrical equipment).
In addition, all such combinations -
systems - shall comply with the standard
IEC 60601-1-1, Safety requirements for
medical electrical systems. Equipment
not complying to IEC 60601 shall be
kept outside the patient environment, as
defined in the standard. 1)Any person
who connects external equipment to
signal input, signal output or other
connectors has formed a system and is
therefore responsible for the system to
comply with the requirements of IEC
60601-1-1. If in doubt, contact qualified
technician or your local representative.1)
The normal distance can be mentioned
i.e. at least 1.5 m from the patient or the
patient support.

Extern alarm:

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

RS-232C:

Max input voltage: ±15 V


DC
High level min output 5.0 V
voltage: DC
Low level max output -5.0 V
voltage: DC
Max output current: ±5 mA
DC

RS-422/Current loop:

Typ current: 20 mA
DC
Max current: 50 mA
DC

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Battery back-up
Battery back-up of power 24 volt, 6,5 Ah
supply
Running time >30 minutes
Fuse T 15 A

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Performance and specification - Supervisory
system
Blood pressure supervision
Venous pressure:

Operating range -700 to 750 mmHg


Alarm limits: 10 to 500 mmHg in treatment mode, -100
to 500 mmHg in priming mode
Accuracy: -700 to -500 mmHg, ±10% -500 to 500
mmHg, ±5 mmHg or ±3%, whichever is
largest 500 to 750 mmHg, ±10%
Arterial pressure:

Operating range -700 to 750 mmHg


Alarm limits: -700 to 750 mmHg
Accuracy: -700 to -500 mmHg, ±10% -500 to 500
mmHg, ±5 mmHg or ±3%, whichever is
largest 500 to 750 mmHg, ±10%

Extracorporeal blood loss to the environment


Detection method: Venous pressure supervision

Air detection
Detection method: Ultrasonic detector placed at the venous
drip chamber. The detector has a two
channel structure and the function of the
detector is tested at the function test made
by the microcomputers.
Drip chamber size: Diameter 22 mm
Sensitivity: Bubbles larger than 1 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.

Extracorporeal blood loss due to coagulation


Detection method: Supervision of the stop time of the blood
pump
Alarm: The attention “BLOOD PUMP STOP
TIME EXPIRED, Start Blood pump”.

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Dialysis fluid preparation
Temperature:

Temperature alarm (fixed) 40 °C (±0.5 °C)


Overheat protection: The heater can only be on if there is a
flow through the heater. The flow is
detected by a flow switch.
Conductivity:

Alarm limits: ±5 % of the calculated conductivity set


value

Ultrafiltration supervision
TMP: TMP is defined as the difference, Pb out -
P d out, where Pb out is the venous pressure
and P d out is the pressure measured in the
dialysis fluid, where it enters the machine
after the dialyzer.
Alarm limits: -100 to 500 mmHg
Accuracy: ±500 ( ±10 mmHg or ±5 %, whichever is
largest )

Blood leakage detection


Detection method: Infrared light detector.
Sensitivity: Alarm will be given for ≥0.3 ml blood,
haematocrit 32%, per minute at 700
ml/min dialysis fluid flow. Time delay
for alarm, maximum 5 seconds (diffusion
mode).

pH-meter
Measuring range: 1 - 9.9 pH, measured in the dialysis fluid
before dialyzer.
Accuracy: ±0.2 pH
Alarm limits: 5.0 to 9.0 pH

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Physical data
Dimensions and weight
Width: Approx. Machine 480 mm, stand 580
mm.
Depth: Approx. Machine 600 mm, stand 625
mm.
Height: Approx. 1270 mm (without infusion
stand).
Weight: Approx. 62-78 kg (depending on
options).

Infusion stand
Maximum total load: 2 kg

References
Assembly Drawing K23000

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Materials in contact with dialysate,
concentrates and water
Polymers

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

Metals

Stainless steel SS2343


Stainless steel SS2353
Stainless steel SS2562
Titanium
Platinum

Others

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

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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 )

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 )

H CEN9369 Revision.10.2005
Program version 12.xx AK 95 S Service manual - Technical data and specifications 3:15
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Standards
The machine complies with the following standards:

IEC 60601-1 General requirements for safety, Class I, type B

IEC 60601-2-16 Particular requirements for safety of haemodialysis,


haemodiafiltration and haemofiltration equipment

IEC 60601-1-1 Safety requirements for medical electrical systems

IEC 60601-1-2 Electromagnetic compatibility

IEC 60601-2-30 Particular requirements for the safety of automatic


cycling indirect blood pressure monitoring equipment

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

HCEN9369 Revision.10.2005
3:16 AK 95 S Service manual - Technical data and specifications Program version 12.xx
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Technical Data

Chapter 3
Technical data and specifications for AK 95

AK 95 HCEN9135 Rev. 10.2005 3:1

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Technical Data

Machine specification AK 95, K18022

Blood flow control


Double needle
Flow rate: 0 and 20 - 500 ml/min (-150 mmHg prepump pressure,
pump segment diameter 7.9 mm)
Flow accuracy: ±10 ml/min or ±10 %, whichever is largest
Accumulated blood volume: 0 - 999 litres
Volume accuracy: ±10 %

Single needle
Flow rate: 0 and 20 - 500 ml/min (-150 mmHg prepump pressure,
pump segment diameter 7.9 mm)
Flow accuracy: ±10 ml/min or ±10 %, whichever is largest
Time control: 2 - 20 seconds, arterial and venous time.
Pressure control: 10 - 500 mmHg ( ±5 mmHg or ±3 %, whichever is largest),
venous pressure control
Accumulated blood volume: 0 to 999 litres
Volume accuracy: ±10 %

Blood pressure supervision


Venous pressure:
Operating range -700 to 750 mmHg
Alarm limits: 10 to 500 mmHg in treatment mode,
-100 to 500 mmHg in priming mode
Accuracy: -700 to -500 mmHg, ±10 %
-500 to 500 mmHg, ±5 mmHg or ±3 %, whichever is largest
500 to 750 mmHg, ±10 %

Arterial pressure:
Operating range -700 to 750 mmHg
Alarm limits: -700 to 750 mmHg
Accuracy: -700 to -500 mmHg, ±10 %
-500 to 500 mmHg, ±5 mmHg or ±3 %, whichever is largest
500 to 750 mmHg, ±10 %

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Technical Data

Air detection
Detection method: Ultrasonic detector placed at the venous drip chamber. The
detector has a two channel structure and the function of the
detector is tested at the function test made by the
microcomputers.
Drip chamber size: Diameter 22 mm
Sensitivity: Bubbles larger than 1 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.

Heparin administration
Heparinization: 0 to 10 ml/h (±1 ml/5h or ±5%) The accuracy is based on
tests with 20 ml and 30 ml syringes
Syringe size: Syringes shall comply with ISO 7886-2. Upon delivery, the
machine is set for a 20 ml Terumo syringe. Syringes of other
volumes and brands can be set.
Stop time: Heparinization stops before end of treatment 0.00 to
9.59 h
Counter pressure: Maximum 400 mmHg
Accumulated heparin volume: 0 to 999.9 ml

Water supply
Flow rate: During treatment: maximum 770 ml/min
During disinfection and rinse/drain: a maximum flow rate of
800 ml/min is required.
Minimum inlet pressure: 0.12 MPa (1.2 bar)
Maximum inlet pressure: 0.6 MPa (6 bar)

Inlet temperature: +5 to +30 ºC


Connector in/outlet: Diameter 8 mm
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.
Drain: The drain tube outlet must be placed between floor level and
maximum 1.2 m above the outlet connection from the fluid
monitor. An air gap to atmospheric pressure must always be
arranged at the tube outlet.
Length of drain tube: <10 m
High pressure guard ±500 mmHg, (±10 mmHg or ±5 %, whichever is largest)
transducer:
Inlet pressure switch (INPS): Increasing: +150 mmHg, ±20 mmHg
Decreasing: +99 mmHg, ±20 mmHg

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Technical Data

Safety guard switch (SAGS): Increasing: -59 mmHg, ±7 mmHg


Decreasing: -74 mmHg, ±7 mmHg

Profiling
UF-rate 0.0 to 4 l/h
Na+, Acetate mode 130 to 160 mmol/l
Na+, Bicarbonate mode 130 to 160 mmol/l
HCO3-, Bicarbonate mode 20 to 40 mmol/l

Dialysis fluid preparation


Pressure regulators: After pressure regulator
PR 1 and the heat 80 kPa (0.8 ±0.1 bar)
exchangers:
After pressure regulator PR2: 130 ±10 mmHg

Temperature 1: Adjustable 35 to 39 °C
Alarm limits: Adjustable 33 to 41 °C
Fixed alarm limit at 40 °C (±0.5 °C)
Accuracy: +0.5/-1.5 °C (+1,0/-2.5 °C with UFD-kit) at the dialysis
fluid outlet from the machine.
Heater capacity: 1000 W (+10 % / -5 %) at 100 V
1300 W (+10 % / -5 %) at 110 V
1750 W (+10 % / -5 %) at 230 V
Overheat protection: Reg-temp 80 °C or
CondA-temp 70 °C in treatment, software
Reg-temp 99 °C in disinfection, software
The heater can only be on if there is a flow through the
heater.
The flow is detected by a flow switch.

1
Accuracy is valid only if dialysis fluid temperature is greater or equal to ambient temperature.

Flow rate: 300-700 ml/min in steps of 20 ml/min


Accuracy: ±10% or 50 ml/min whichever is largest

Degassing: By use of negative pressure , -610 mmHg. Adjustable


degassing pressure between –300 and –700 mmHg (-650
mmHg with 700 ml/min flow rate).

Dialysis fluid pressure: -400 to +300 mmHg.

Proportioning of The proportioning of concentrate is done through


concentrates: conductivity control. The concentrates are pumped into the
system with one/two volumetrically supervised pumps. No
minimum feeding pressure is necessary, the fluid is sucked in.
Maximum feeding pressure, 150 kPa.
Acetate: Na+ , 130 to 160 mmol/l, (±3 mmol/l)

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Technical Data

Bicarbonate: Na+ , 130 to 160 mmol/l, (±6 mmol/l)


HCO3- , 20 to 40 mmol/l, (±6 mmol/l)
Measuring range: 12 to 16 mS/cm
Alarm limits: To 5 % of the calculated conductivity set value

pH-meter: 1 – 9.9 pH, measured in the dialysis fluid before dialyzer.


Accuracy: ±0.2 pH
Alarm limits: 5.0 to 9.0 pH

Ultrafiltration control
Volume control: Direct electromagnetic measurement of dialysis fluid flow,
before and after the dialyzer.
UF volume: Adjustable 0 to 10.00 l
Accuracy of measured ±50 ml/h or ±1 % whichever is largest
volume:
UF coefficient : Maximum 85 ml/h/mmHg
UF rate: 0.0 to 4 l/h, given by the set values of UF volume and
treatment time.
Time: Remaining treatment time control, adjustable up to 9 h 59
min.

TMP: TMP is defined as the difference, Pb out - P d out, where Pb out


is the venous pressure and P d out is the pressure measured in
the dialysis fluid, where it enters the machine after the
dialyzer.
Alarm limits: -100 to 500 mmHg
Accuracy: ±500 ( ±10 mmHg or ±5 %, whichever is largest )

Blood leakage detection


Detection method: Infrared light detector.
Sensitivity: Alarm will be given for ≥0.3 ml blood, haematocrit 32%, per
minute at 700 ml/min dialysis fluid flow.
Time delay for alarm, maximum 5 seconds (diffusion mode).

Disinfection and cleaning


Chemical disinfection:

Peracetic Acid Program (presetable)


Concentration of disinfectant 3.5 % peracetic acid
Concentration in machine 0.1 %; i.e. diluted 1 + 34 (1:35)
Volume approx. 85 ml (with UFD-kit approx. 92 ml)
Contact time between treatments 10 minutes
Contact time overnight or when not in
use (recommended with UFD-kit) Minimum 3h dwell time
Total time 30 minutes (with UFD-kit 59 minutes)
including 10 min contact time

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Technical Data

Hypochlorite Program (presetable)


Concentration of disinfectant 10 % available chlorine
Concentration in machine 0.5 %; i.e. diluted 1 + 19 (1:20)
Volume Approx. 145 ml (with UFD-kit approx. 153 ml)
Contact time between treatments 10 minutes
Contact time overnight or when not in
use Maximum 20 min, not intended for
overnight disinfection!
Total time 30 minutes (with UFD-kit 48 minutes)
including 10 min contact time

Formaldehyde Program (presetable)


Concentration of disinfectant 37 % formaldehyde
Concentration in machine 3.7 %; i.e. diluted 1 + 9 (1:10)
Volume Approx. 275 ml (with UFD-kit approx. 290 ml)
Contact time between treatments 20 min
Contact time overnight or when not in
use (recommended with UFD-kit) Minimum 6h dwell time
Total time 119 minutes (with UFD-kit 150 minutes)
including 20 min contact time

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

AK 95 Total Time [min]


Disinfection programs
230 V 110 V 100 V
Heat 35 39 49
With UFD Heat Citric acid 20% 52 57 67
installed
Heat CleanCart 49 54 64

Heat 33 37 47
Without UFD Heat Citric acid 20% 50 55 65
Heat CleanCart 46 51 61

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Technical Data

Auto Heat disinfection: One of two alternatives for auto heat disinfection can be
selected.

AK 95 Total Time [min]


Disinfection
programs 230 V 110 V 100 V

With UFD Heat 31 35 45


installed Heat 43 49 58
CleanCart

Without UFD Heat 31 35 45


Heat 43 48 58
CleanCart

Temperature: +93°C (measured after heating rod)


≥80°C (measured in the outlet before the heat exchanger )
Note: The temperatures are verified at nominal values for the mains
voltage and at 20°C ambient temperature.

Rinse/Drain :
Rinse/Drain 10 minutes
Drain 4 minutes

Exterior cleaning: All outside parts of the machine can be cleaned with ethanol
(70%) or isopropanol (60%).

Note ! Total Time for Disinfection Programs are estimated and may vary.

Power supply
Mains voltage: 100 V(at 50 Hz or 60 Hz) , 110 V(at 50 Hz or 60 Hz) or
230 V(at 50 Hz or 60 Hz) (∼,AC), (±12%). The voltage
has to be specified before installation.
Note: The user must verify the quality of the protective earth in the
installation.
Power consumption: 2025W at 230V
1575W at 110V
1275W at 100V
Cable length: 3m
Cable area: AWG 16 at 100V and 110V
1 mm2 at 230V
External fuses: For 100/110 V, 2 x 10AT for heater and 2 fuses specified by
Philips (se AC/DC unit K15740 008) For 230V, 2 x 10AT
for heater and 2 fuses specified by Philips (se AC/DC unit
K15740 007)

AK 95 HCEN9135 Rev. 10.2005 3:7

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Technical Data

Mains plug: For 100/110V, Hospital grade, earth plug, type IEC 83 A5-
15
For 230V, Dual earth system plug, type IEC 83 C4
Maximum earth leakage 100 µA (100V)
current: 150 µA (110V)
205 µA (230V, 50 Hz )
400 µA (230V, 60 Hz )
Maximum patient leakage 9 µA (100V)
current: 11 µA (110V)
20 µA (230V)
Note: All leakage currents specified are without external equipment
connected to the AK 95.

Connection of external equipment


External connector: 25 pin D-Sub with RS-232C or RS-422/Current loop.
Opto insulated fulfilling IEC 60601-1-1.
External equipment: External equipment intended for connection to signal input,
signal output or other connectors, shall comply with relevant
IEC standard (e.g. IEC 60950 for IT equipment and the IEC
60601 series for medical electrical equipment). In addition, all
such combinations – systems – shall comply with the
standard IEC 60601-1-1, Safety requirements for medical
electrical systems. Equipment not complying to IEC 60601
shall be kept outside the patient environment, as defined in
the standard. 1)

Any person who connects external equipment to signal input,


signal output or other connectors has formed a system and is
therefore responsible for the system to comply with the
requirements of IEC 60601-1-1. If in doubt, contact qualified
technician or your local representative.

1)
The normal distance can be mentioned i.e. at least 1.5 m
from the patient or the patient support.

Extern alarm: Max voltage: 24 V AC or DC


Max current : 100 mA AC or DC

RS-232C: Max input voltage: ±15 V DC


High level min output voltage: 5.0 V DC
Low level max output voltage: -5.0 V DC
Max output current : ±5 mA DC

RS-422/Current loop : Typ current : 20 mA DC


Max current : 50 mA DC

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Technical Data

Dimensions and weight


Width: Machine 350 mm, stand 625 mm.
Depth: Machine 420 mm, stand 680 mm.
Height: 1270 mm.
Weight: 62 kg

Infusion stand
Maximum total load: 2 kg

Materials in contact with dialysate, concentrates and water


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

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

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

Safety
The machine complies with :
IEC 60601-1 General requirements for safety, Class 1, type B
IEC 60601-2-16 Particular requirements for hemodialysis equipment
IEC 60601-1-1 Safety requirements for medical electrical systems
IEC 60601-1-2 Electromagnetic compatibility

Environmental data – operation


Ambient temperature: +10 to +35°C.
Relative humidity: 30 to 85 %.RH
Air pressure: 700 to 1060 hPa

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Technical Data

Environmental data – transportation and storage


Ambient temperature: -20 to +70 °C.
Relative humidity: 10 – 96 % RH
Air pressure: 500 to 1060 hPa

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
(RH) is
+40 °C

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.

3:10 AK 95 HCEN9135 Rev. 10.2005

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Service Technicians Guide

4. Service technicians guide


Introduction
Operator’s panel .......................................... 4:2
Hygiene group ........................................ 4:3
Mode group ............................................ 4:3
Treatment overview group .................... 4:3
Stand-by group ....................................... 4:3
Alarm buttons ........................................ 4:3
The flow paths ........................................ 4:4
Display and setting group ..................... 4:5
Main treatment parameters .................. 4:5
Setting parameters ................................ 4:5
Program version handling ..................... 4:5
Night light .............................................. 4:5
Technical error handling ............................ 4:6

Service maintenance menu


General handling ........................................ 4:7
Preset mode ................................................. 4:8
Manual preset ........................................ 4:9
External Preset ...................................... 4:9
Default preset ...................................... 4:10
Finish of Preset ................................... 4:10
Presetable parameters in Auto-
priming ................................................. 4:11
How to preset concentrate ................... 4:13
Service mode ............................................. 4:15
Service mode flow diagram .................. 4:16
Selection diagram ................................ 4:17
Utility flow diagram ............................ 4:18
Diagnostic flow diagram ...................... 4:19
BM diagnostics ..................................... 4:20
FM diagnostics ..................................... 4:21
Pump diagnostics ................................. 4:22
Variable flow diagnostics ..................... 4:23
UF diagnostics ..................................... 4:24
Valves diagnostics ................................ 4:24
Logging mode ............................................ 4:25
Logging mode flow diagram ................ 4:26
Error buffers in Logging mode ............ 4:27
Arrays ................................................... 4:28

AK 95 / AK 95 S Service Manual 4:1


HCEN 9136 Rev. 10.2005

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Service Technicians Guide

Operator’s panel
The blood unit, the fluid unit and the mixing If you want more detailed information about the
unit are controlled and supervised from the buttons and their functions, see Operator´s
operator’s panel. The panel consists of a number manual.
of buttons, bargraph displays, flow paths, a time
display, an information display, a blood flow The panel is divided into five logical groups:
knob and one set knob.

1. Hygiene group: ON/OFF, Chem Disinf, Heat 4. Stand-by: Blood pump, Reset, Mute, Fluid
disinf, Rinse/Drain, Auto Heat and Auto Rinse. bypass and Start UF Stop.

2. Mode group: Isol UF, SN, Acetate, Bicarbo- 5. Display/Setting: operator/machine communi-
nate, and Volume Control. cation, setting of parameters (“Set”-knob),
setting of blood flow (“Blood flow”-knob).
3. Treatment Overview group contains
bargraphs and buttons for:
- Venous pressure, Blood flow, SN Data (Single
Needle Treatment), Temperature and Conduc-
tivity.
- Arterial pressure, TMP, UF volume and UF
rate, Time (Remaining treatment time).
- Heparin, Priming, Auto Priming (Priming
functions) and Rinseback.
- Air detect, Attention, Technical alarm, pH, and
Blood leak.
- Profiling and BPM.

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Service Technicians Guide

1. Hygiene group The five buttons in the center, have no Bargraph


These buttons are used to select machine modes displays, but the corresponding information for
mainly related to disinfection, rinsing and heparin and time is displayed when the buttons
draining of the fluid unit and the mixing unit. are pressed.

Any button in this group must be pressed for at


least 3 sec. before the function is activated. An 4. Stand-by group
active mode is indicated by a lit button. For These buttons can be used for direct control and
draining of the AK 95 S, press the Rinse/Drain stand-by of certain functions.
button twice.

In the Hygiene-group, the buttons must be kept Is used to stop and start the blood pump.
depressed for at least 3 seconds to activate the
function.
Is used to silence the buzzer at an alarm.
If the alarm is serious the buzzer is muted only
2. Mode group for 30 seconds when the button is pressed.
The buttons in this group are used to select
different treatment modes. Fluid
bypass
Is used to bypass the dialysis fluid from the
Any button in this group must be pressed for at dialyzer.
least 3 sec. before the function is activated. An
active mode is indicated by a lit button. In the START
UF Is used for initiation and termination of
STOP
Mode group, the buttons must be kept depressed
for at least 3 seconds to activate the function. treatment. It should normally not be pressed
during treatment. In the Service mode this
button is used for storing calibration values.
3. Treatment overview group
This group graphically shows the status of the
Alarm buttons
treatment and allows for a complete overview of
all important treatment parameters. The alarm buttons are placed to the right of the
3.1. Bargraph display flow picture. These are normally not lit.
3.2. Flow diagram
3.3. Time display If a buzzer signal is combined with ,
attention from the operator is required.
Setting of a parameter can generally be de-
scribed as follow:
A buzzer signal combined with , indicates a
1. Press the wanted parameter button. technical error. For more information see page
The actual information will be displayed on the 4:6.
information display.

The buzzer will be silenced with or with the


2. Press the (select key) until the parameter
corresponding alarm key.
you want to change is flashing.
Set the value by turning the Set knob.

The Bar graph displays operate as follows:

• Red bars for alarm limits

• Yellow bars for actual value

• Green bars for set value

For more details, see next page.

AK 95 / AK 95 S Service Manual 4:3


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Service Technicians Guide

The flow paths


The flow paths for fluid and blood are shown in different colours on the panel:

Blood path

Ultrafiltration
path

Dialyzer
path

Bypass path
Blood path Dialyzer path
The blood path ligths up (red) as soon as the The dialyzer path is lit when dialysis fluid
machine detects blood. Locks in blood mode passes through the dialyzer.
after 20 seconds. Colours: Green = Fluid is correct
Orange = Fluid incorrect
Bypass path (wrong Temp and/or Cond)
The bypass path is lit when the dialysis fluid is
manually or automatically bypassing the dia- Ultrafiltration path
lyzer.
The ultrafiltration path is yellow during isolated
During certain alarm situations, and during the
UF and during bypass.
self-calibration of the UF-system, the machine
will automatically bypass the dialyzer.
Treatment Treatment, fluid bypass, Isolated UF
Red Red

Green Yellow
Green Green Green Green

Treatment, fluid NOT OK Standby, fluid OK/NOT OK


Red

Yellow
Yellow
Orange Orange Green/Orange Bypass Green/Orange

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Service Technicians Guide

5. Display and setting group Setting parameters


The information display and its two buttons 1. Press the and the text on the display will
together with the Set-knob is used for displaying
and setting all parameters exept the blood flow. flash.
The blood flow is always directly controlled with
the Blood flow-knob. 2. Change the value with the Set-knob.
5.1. Information display
5.2. Blood flow knob The “Hold-button” is used to maintain the
5.3. Set knob text and values showed on the information
display. When you want to leave a hold position
and turn off the information display, press this
button again.

"Hold". If pressed when


the information display is
lit, the display is "held" Information display - goes blank after
forever. If pressed again, 15 seconds, unless "Hold" is pressed.
the display disappears.

Blood Set
flow

"Select " - selects


changeable values in Blood flow-knob ;
the information display changes the blood flow

Set-knob; changes
a selected value

Main treatment parameters Program version handling


Anytime the information display is dark, the At start-up the program decides which PROM
machine will display the main treatment param- has the latest status and reads out the valid
eters: Blood flow, Venous pressure, TMP, and PROM-configurations. This will prevent the
UF volume, when “Select” is pressed: possibility of mixing PROMS from different
program versions when installing/updating the
Bl:ml/min V p :mmHg TMP:mmH g UFV:l AK 95 S. If the configuration is invalid, an error
0 0 0 0.00 code will be issued.

The current program version will be displayed


If “Select” is pressed again, the dialysis fluid for a few seconds at start-up.
flow will be displayed.
Night light
Fluid flow: ml/min All buttons and bar graphs become unlit if
0
“Mute” button is pressed for three seconds.
Any alarm or operator display activity will
deactivate the function. To activate “Night-light”
the preset-parameter 1-34 has to be set to true.

AK 95 / AK 95 S Service Manual 4:5


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Service Technicians Guide

Technical error handling


For more information about the error message
refer to the Error Code List for AK 95 S,
HCEN 9091.

Note! It is important that the program version


on the Error Code List corresponds with the
AK 95 S PROM.

If a technical error appears, the AK 95 S places


an error code in a memory, called the error code
buffer. The buffer's content is kept after the
machine is switched off, allowing the technician
to view it at a later time.
When an error is generated, the machine
alarms, and the buffer can be accessed by press-
ing the Technical Error button.

The main groups can be interpreted as follows:

C CB ... are generated by Blood functions


C CC ... are generated by Common functions
C CF ... are generated by Fluid functions
C CO ... are generated by OpCom1) functions
P PTRA ... are generated by Ptransducer2)
functions

1)
OpCom=Operator’s Communication
2)
PTransducer= Protective system transducers.

All different error codes are available in the


Error Code List.

The position of the error in the buffer.

Total numbers of errors in the buffer.

Buf: 04 (07)
C COF 088 031 27 Oct 05 6:43

The error code. Time stamp: When


did it happen.

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HCEN 9136 Rev. 10.2005

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Service Technicians Guide

Service maintenance menu


Below follows a description of how to use the To step through the Service mode, use the Control
buttons in the Control group for preset, logging buttons as described below.
and service mode. By way of introduction the
information display together with the two SET knob and SELECT key, to select.
control buttons are illustrated step by step.
Subsequent information are given in the differ-
ent flow diagrams.

General handling
To get the leading information on the display it
HOLD key, to step backward.
is necessary to press the button and two
hidden buttons above the dialyser symbol at the
same time for 5 sec.
NOTE! The info. display must be dark.

The following will be displayed:

MAINTENANCE SUPPORT SELECTION


Logging Service/Preset

Select mode with the Set knob and press to


confirm.

To enter the Serv/Pres mode a code must be set.

ENTRY PRESET/SERVICE CODE


Code: XX XX XX

Set the code with the Set knob (two digits for
each field). If you do not confirm the code
within 40 seconds, restart from the first figure is
required.

• Choose the desired mode by turning the


Set knob.

• When desired mode is blinking, confirm


with the button.

START
• To store values or modes, press UF
STOP
.

• To step backwards and finally exit from


the menu, press .

AK 95 / AK 95 S Service Manual 4:7


HCEN 9136 Rev. 10.2005

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Service Technicians Guide

Preset mode
In the Preset mode the set up of AK 95 S is
confirmed. Following choices are set in preset
mode:

• Start up values
• Configuration
• Set values and limits
• Override times
• Auto priming parameters
• Rinse Back
• Disinfection parameters
• Single needle paramers
• Acetate concentrates
• Bicarbonate concentrates
• BPM settings
• Profiling

Enter preset mode as follows:

MAINTENANCE SUPPORT SELECTION


Logging Service/Preset

Select Service/Preset

MAINTENANCE SELECTION
Fch Preset Service

Select Preset and following dispalys shows up:

INITIALIZING PRESET MODE

SELECT PRESET TYPE


Manual Ext Default

Select "Manual" when AK 95 S is preseted from


the operatorspanel and select "Ext" when the
AK 95 S is connected to a PC and preseted via
the Gambro software GXP.

It is also possible to preset a AK 95 S machine


from another AK 95 S machine with a Monitor to
Monitor preset cable, K2 2753 001.

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Service Technicians Guide

Manual preset External Preset

SELECT PRESET TYPE


SELECT PRESET TYPE
Manual Ext Default
Manual Ext Default
Select Manual with the SET knob and press
Select Ext with the SET knob and press
SELECT key.
SELECT key and following display shows up:
The AK 95 S Presets are based on the concept of
groups. The main groups are:
SELECT EXTERNAL PRESET TYPE
• 0 Start up PC Send Receive
• 1 Configuration
• 2 Set values and limits
• 3 Override times External preset in AK 95 S includes both preset-
• 4 Auto priming ting the machine from a PC connected to the
• 5 Rinse Back machine (PC preset), and presetting one
• 6 Disinfection machine with the contents of another (duplicate
• 7 Single needle preset)
• 8 Acetate concentrates
• 9 Bicarbonate concentrates This set up is used for customising (within
• 10 BPM setting certain limits) AK 95 S to each clinic’s wishes.
• 11 Profiling
For more information, contact Gambro
Each main group contains a different number of Technichal Service.
sub groups.

How to preset manualy

1. Select main group with the SET knob.

2. Press

3. Select sub group with the SET knob.

4. Press

5. Select preset value with the SET knob.

START
6. Press UF
STOP
to store the new value.

7. Continue with next preset.

Note!
Use to step back in the preset menue.

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Service Technicians Guide

Default preset Finish of Preset


To complete the Presets menu, press to step
SELECT PRESET TYPE backwards until following display shows up:
Manual PC Default
MAINTENANCE SUPPORT SELECTION
When selecting the last “group” “Default preset” Fch Preset Service
following display appears:

SELECT DEFAULT PRESET TYPE


Set Fch and press to perform a Functional
Complete Partly
check.

Complete
Complete default means that all presets are
initiated to the default values. NOTE!
•All preset values and limits must be verified
Select “Complete” with the SET knob and press before treatment start.
the SELECT key following display appears:
•Preset concentrates must be verified by
WARNING!!! ALL PRESETS WILL BE laboratory test of the dialysate produced by the
AK 95 S.
STORED AS DEFAULT VALUES
•Preset for pump segments must be verified by
Press the HOLD key and the machine returns to comparing the pumped volume and a reference
the first display in Manual preset mode. volume.
Press START/UF/STOP key and all presets will
be initiated to the default values.

When ready the machine returns to the first


display in Manual preset mode.

Partly
Partly default sets all values to default values
except the values for concentrates that remain
intact.

Select “Partly” with the SET knob and press the


SELECT key following display appears:

WARNING!!! SOME PRESETS WILL BE


STORED AS DEFAULT VALUES

Press the HOLD key and the machine returns


to the first display in Manual preset mode.

Press START/UF/STOP key and all presets


except the concentrate presets will be initiated
to the default values.

When ready the machine returns to the first


display in Manual preset mode.

Note! When selecting Default preset, AK 95 will


perform a Chem Rinse at the next start up.

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Service Technicians Guide

Presetable parameters in Autopriming

0 Auto priming install Installed / Not installed

1 Auto priming fill flow 0 - 500 ml/min


This is the initial flow rate when
filling the dialyzer and blood lines.

2 Auto priming fill time 0 - 300 s


This is the time for filling the dialyzer
and blood lines completely.

3 Auto priming press build time 0 - 30 s


The venous clamp closes. This is the time for
building up the venous pressure alarm limit.

4 Auto priming press drop time 0 - 60 s


The measurement time for the pressure
drop when performing the leakage test
of the dialyzer.

5 Auto priming press drop 0 - 100 mmHg


The acceptable pressure drop when per-
forming the leakage test of the dialyzer.

6 Auto priming prim flow 0 - 500 ml/min


This is the flow rate during the priming
phase as well as during the flushing phases.

7 Auto priming prim time 0 - 600 s


This is the required time for the priming
phase.

8 Auto priming cycle time 0 - 60 s


This time specifies the opening and closing
time of the venous clamp during the priming
phase.

9 Auto priming level time 0 - 60 s


This is the time necessary to fill up the
venous drip chamber to a correct level.

10 Auto priming flush time 1 0 - 300 s


During this time, the remaining air in
the dialyzer and blood lines will be expelled.

11 Auto priming flush time 2 0 - 600 s


If a second flush is requested, select this time.

12 Auto priming venous line time 0 - 120 s


The time when the venous clamp is open.
In order to expell any air bubbles in the
venous line.

13 Auto priming FM active Avail / Not Avail

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Service Technicians Guide

Preset parameter description

The presetable parameters for autopriming are For instructions how to operate the autopriming
explained in following diagram. The priming mode, refer to AK 95 S Operatorsmanual.
volume as a function of the time for the seven
different phases in autopriming: Before starting the autopriming, it is essential
• Fill that correct settings of the preset parameters
• Pressure test have been made, corresponding to the type of
• Priming dialyzer and blood lines used.
• Flush 1 Make sure that the total volume of priming
• Flush 2 solution is enough to cover the preset flow rate
• Level adjustment in the venous drop chamber and priming time.
• Venous line fill
The preset values must be set in accordance
with the respective users needs.

Priming
volume Pressure

Venous pressure
Pressure drop
alarm limit

Pressure Pressure Time


build timedrop time

Level Venous
adjust- line fill
ment
Flush 2
Pressure test
Flush 1

Priming

Fill

Preset
EN1078

Time
parameter 1,2 3,4,5 6,7,8 6,10 6,11 6,9 6,12

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Service Technicians Guide

How to preset concentrate

Enter Service maintenance menu: The assignment of concentrates to the alterna-


tives is open - any combination of concentrate
types can be used.
MAINTENANCE SUPPORT SELECTION
Logging Service/Preset All values which are going to be set are specified
at the label on the concentrate containers.
Select Service/Preset NOTE! If the values are present as both
concentrated and diluted concentrate, use
the concentrated values.
MAINTENANCE SELECTION
Fch Preset Service Example
Following example will show how to preset the
Select Preset and following text is displayed: AK 95 S for Gambro BiCart together with A-
concentrate 201.
INITIALIZING PRESET MODE
Bicarbonate concentrates
9
SELECT PRESET TYPE
Manual Ext Default 1. Press .

Select Manual.
Bicarbonate alt. 1
Scroll with the SET-knob: 9-0
Group 8 for presetting Acetate concentrates and
group 9 for Bicarbonate concentrates. 2. Press .
Press .
Liquid Bicarbonate 1
• 0 Start up 9-0-0
• 1 Configuration
• 2 Set values and limits
BiCart 1
• 3 Override times
• 4 Auto priming 9-0-1
• 5 Rinse Back
• 6 Disinfection 3. Select BiCart 1 and press .
• 7 Single needle
• 8 Acetate concentrates
• 9 Bicarbonate concentrates
BiCart 1 [gram/l, molecule]
9-0-1-0
AK 95 S has six memories, called “alternatives”
for concentrate presets - three for Acetate mode, BiCart 1 [mmol/l, molecule]
and three for Bicarbonate mode. 9-0-1-1
The default concentrates are:
BiCart 1 [mmol/l, ion]
Acetate mode:
Alt 1: D01
9-0-1-2
Alt 2: D94
Alt 3: D53 4. Select one of these alternatives and preset the
concentrates according to the label on the con-
Bicarbonate mode: centrate container.
Alt 1: 201 + BiCart
Alt 2: 203 + BiCart For example: BiCart 1 [gram/l, molecule]
Alt 3: D360 + D300 (Liquid bicarbonate) and press .

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Service Technicians Guide

5. Place the alphanumerical overlay, A a L l Mm 0 = 1 &

K1 5824 001, on the operatorspanel. B b Cc K k P p Q q N n 2 " 3 /

Dd Ee O o T t U u R r 4 # 5 +

6. Edit correct values, press after each S s V v

parameter. Ff G g
Ww X x
6 % 7 -

Hh I i 8 _
Y y Z z
START
7. Press UF
STOP
when all parameters are done SHIFT J j 9 .

to load the values into the EEPROM. PRESETOVERLAY AK90s

8. Press to exit.

Following parameters are available in the concentrat preset:

Acetate concentrate

gram/l - molecule mmol/l - molecule mmol/l - ions

Label Label Label


CH3COONa CH3COONa Na+
H2O with CH3COONa NaCl K+
NaCl KCl Mg2+
Ac KCl MgCl2 Ca2+
MgCl2 CaCl2 Cl-
H2O with MgCl2 CH3COO-
CaCl2
H2O with CaCl2

Bicarbonate concentrate

Label Label Label


Acid (CH3COOH) Acid (CH3OOH) Na+
CH3COONa CH3COONa K+
H2O with CH3COONa NaCl Mg2+
NaCl KCl Ca2+
A KCl MgCl2 Cl-
MgCl2 CaCl2 CH3COO-
H2O with MgCl2 H+
CaCl2
H2O with CaCl2

NaHCO3 NaHCO3 Na+


NaCl NaCl HCO3-
B CH3COONa CH3COONa Cl-
H2O with CH3COONa CH3COO-

BiCart
BiCart BiCart BiCart

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Service Technicians Guide

Service mode
In the Service mode it is possible to change To step through the Service mode, use the Control
values and the status of both the hardware and buttons as described below.
the software.
SET knob and SELECT key, to select.
Before you enter the Service mode this is dis-
played:

MAINTENANCE SUPPORT SELECTION


Logging Service/Preset

Select Service/Preset, set the service code and HOLD key, to step backward.
enter the Service mode.
Following displayshows up:

MAINTENANCE SELECTION
Fch Preset Service

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Service Technicians Guide

Service mode flow diagram

SELECT SERVICE MODE


Exit Calib Utility Diagnose

MAINTENANCE SELECTION See “Diagnostic flow diagram”


Fch Preset Service See “Utility flow diagram”

SELECT CALIBRATION FACILITY


Transd AD-Conv Clock Other

SELECT CALIBRATION FACILITY


Variable flow Estim.temp drop
SELECT FLOW SUPPORT
Extern Intern UF

See Selection diagram See UF Time now: 2005 Oct 20 Th 17:41


calibration, New time: 2005 Oct 20 Th 18:00
Chapter 6.
•There is no flow Year Month Date Day Time
(pumps stopped)
in External mode.

•In Internal AK 95 S
maintains a flow.

SELECT AD-CONVERTER
CPU C CPU P CPU W MM 95

See AD system calibration.

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Service Technicians Guide

Selection diagram

Start VENOUS PRESSURE TRANSDUCER CPU P RUNTIME METER

pH TRANSDUCER
VENOUS PRESSURE TRANSDUCER CPU C

HPG PRESSURE TRANSDUCER


ARTERIAL PRESSURE TRANSDUCER

DEGASSING PRESSURE TRANSDUCER


PRIMING DETECTOR

DIALYSIS PRESSURE TRANSDUCER

BLOOD LEAK DETECTOR

CONDUCTIVITY A B P TRANSDUCER

CONDUCTIVITY A TRANSDUCER

CONDUCTIVITY P TRANSDUCER

CONDUCTIVITY B TRANSDUCER

To step through the Pressing the Select knob


Selection diagram (a loop), opens the calibration display.
use the SET knob.

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Service Technicians Guide

Utility flow diagram

SELECT SERVICE MODE


Exit Calib Utility Diagnose

UTILITY SELECTION MENU


Dis/Calc Ext.Fch V.angle Drain
To discontinue Chemical-
disinfection

ADJUST VIEWING ANGLE


Display Bargraphs
DESINF/DECALCIF SELECTION MENU
Chem.sts Disinf/Decalc Attention

CHEM DISINF INDICATION ERASURE


Keep CHEM DIS pressed and wait Extended Function Check
Interactive Stand-alone

Erasing Chemical disinfection


indication

REMOVE DISINF/DECALC ATTENTIONS


Chemicaldisinfection indication KEEP RINSE/DRN pressed and wait
is OFF!

Removing DISINF/DECALC ATTENTIONS

Disinfection and Decalcification


attentions are removed

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Service Technicians Guide

Diagnostic flow diagram


SELECT SERVICE MODE
To use all facilities in the Diagnostic Selection Exit Calib Utility Diagnose
Menu, a Gambro training course is recom-
mended.

WARNING! In Diagnostics it is possible to DIAGNOSTICS SELECTION MENU


make settings far outside normal limits and System BM FM
technical errors may appear. For more informa-
tion, contact Gambro Service.

See
“FM diagnostics”
See
“BM diagnostics”
DIAGNOSTICS SYSTEM MENU
COM I2C Errors

COMMUNICATION PORT TRANSMIT TEST TECHNICAL ERROR SUPPORT SELECT


Press HOLD to abort View Erase

View is the same as in Internal logging, see


Error buffers in logging mode.
I2C TRANSD
Select Erase if you want to erase errors from a
SELECT Scan buffer.

ERASING DIAGNOSTIC BUFFER


SCANNING I2C EEPROMS Press SELECT to confirm

Press SELECT to confirm.

I2C EEPROM SCAN COMPLETED


DIAGNOSTIC ERROR BUFFER ERASED

Name of the
transducer:

XXXXX EEPROM ADDRESS ERROR


Update Escape

XXXXX EEPROM NOT INITIALIZED


Init Escape

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Service Technicians Guide

BM diagnostics

DIAGNOSTICS BM MENU
BPM Lamps Pumps Language

The BPM can be tested for the following:

“INFLATION””, if the inflation time is out of limits All texts for each
the pump is not effective enough or the system is language can be scrolled
leaking.
“DEFLATION”, if the deflation time is out of limits
the valves in the BPM is not working correctly.
“AIRLEAKAGE”, if the leakage is out of limit from
the cuff or from the BPM to the cuff.
“STATIC PRESSURE”, the accuracy of the pressure
transducer is checked against an external reference
instrument.

How to set up the test see Chapter 6, Calibrations.

Press SELECT to view lamps PUMP DIAGNOSTIC MENU


Any lamp not lit is defect Art Hep

ART FREQ SET HEPARIN PUMP DIAGNOSTIC


00000 00000 Counters

COUNTERS SETFREQ EST-ACC ACC


00000 00000 00000

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Service Technicians Guide

FM diagnostics

DIAGNOSTICS FM MENU
Var flow Pumps UF Valves

See
See “Variable flow-diagnostics”
“Valves-diagnostics”

See
“UF-diagnostics”

PUMP DIAGNOSTICS
Press direct keys to ctrl FM

See “Pump diagnostics”

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Service Technicians Guide

Pump diagnostics The machine uses concentrate pump A and


In Pump Diagnostics the AK 95 S enters “nor- conductivity cell A to regulate the conductivity.
mal” treatment mode, starts the fluid part and When the conductivity is stabilised (for 10 sec-
maintains a flow. It runs with the following set onds) inside ±5 % of the set value and the tem-
values: perature is stabilised (for 10 seconds) inside ±1°C
of the set value the fluid path turns to green
• Conductivity 14 mS/cm instead of orange. The lit fluid path always
• Temperature 37.5°C shows the bypass status.
• Degass pressure -610 mmHg
• HPG pressure -100 mmHg Here follows a function description of the used
keys in diagnostic mode:

To regulate some useful parameters in Pump Diagnostics the following displays are available:

To adjust Press Display

Temp
Temperature
TEMP LOW SET HIGH
23.2 00.0 37.5 90.0

Cond COND LOW SET HIGH


Conductivity
6.26 0.00 14.00 25.00

TMP HPG LOW SET HIGH


HPG pressure
-15 -700 -100 700

UF DEG PR LOW SET HIGH


Degass pressure volume
-610 -700 -610 0

To display some useful parameters in Pump Diagnostics the following displays are available:

Press Display

Venous
pressure FL PUMP DTCY CURR DEG PR
485 40.5 109 -602
Arterial SUC PUMP DTCY CURR HPG PR
pressure
485 40.5 109 -200
Blood FL PUMP SUC PUMP HPG PR DIAL PR
flow
485 40.5 -250 -200
UF
rate COND A COND B COND P BLLEAK
14.01 14.11 13.90 005

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Service Technicians Guide

Variable flow diagnostics


This mode can be used to check how many steps
the stepping motor needs to move to obtain a
flow of 500 ml/min.

1. Start the AK 95 S, enter the Service menu


and select Calibrations.

2. Place A-pickup tube in the concentrate


container.

3. Select Other / Variable flow to initiate the


calibration.

DIAGNOSTIC FM MENU
Var flow Pumps UF Valves

Following displays appears:

ADJUSTING VARIABLE DIALYSIS FLOW


Please wait XX seconds

STEPS FLOW CALIB.STEPS


xx ___ ml/min yy

• Steps: The position of the stepper motor


(steps). It can be adjusted with the set knob.

• Flow: The average dialysis flow in the


AK 95 S.

• Calibr. steps: The number of steps at


entrance to service/function check according
to a previous calibration.

Note: If variable flow is not installed following


attention will be displayed:

VARIABLE FLOW IS NOT INSTALLED


Check preset

When diagnostics is aborted (pressing HOLD)


the machine will re-position the motor to the
calibrated value and show the following informa-
tion:

ADJUSTING VARIABLE DIALYSIS FLOW


Please wait $$# seconds.

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Service Technicians Guide

UF diagnostics Valves diagnostics

DIAGNOSTIC FM MENU DIAGNOSTIC FM MENU


Var flow Pumps UF Valves Var flow Pumps UF Valves

Select “UF” with the SET knob and press the Select “Valves” with the SET knob and press the
SELECT key and following display appears: SELECT key and following display appears:

SELECT UF CELL TARATION INLET VALVE (INVA)


Complete Press SELECT key to toggle valve

Turn the SET knob and all the different valves


Select “Complete” with the SET knob and press in the machine that are possible to turn on and
the SELECT key and following display appears: off will “scroll” on the Information display.
When the SELECT key is pressed the selected
COMPLETE UF CELL TARATION valve toggles on or off. When the valves not are
selected they are off.
Please wait
INLET VALVE INVA
AIR INLET VALVE AIVA
A complete taration as in treatment is now
RECIRCULATION VALVE REVA
performed. When ready following display occurs:
FLUSHING VALVE FLVA
RINSING VALVE RIVA
COMPLETE UF CELL TARATION READY ZEROING VALVE ZEVA
DIRECT VALVE CPU C DIVA
DIRECT VALVE CPU P DIVA
TARATION VALVE TAVA
EVACUATION VALVE EVVA
BYPASS VALVE CPU C BYVA
BYPASS VALVE CPU P BYVA

Note! Be careful when open the AIVA to avoid


Fluid leakage into the monitor.

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Service Technicians Guide

Logging mode
In the Logging mode it is possible to check the
condition and the status of both the hardware
and the software.

There are three types of logging facilities, inter-


nal logging (Intern), External logging (Extern)
and technical error logging (Errors).

To step backwards or exit, press

Before you enter the Logging mode this is dis-


played:

MAINTENANCE SUPPORT SELECTION


Logging Service/Preset

Turn the set knob until the text "Logging" starts


blinking, confirm with

The actual information is shown on the informa-


tion display, which is divided into three fields
(0 - 2).
It is possible to choose any AK 95 S parameter
for any of the three fields.

See Logging mode flow diagram.

field 0 field 1 field 2

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Service Technicians Guide

Logging mode flow diagram

SELECT LOGGER FACILITY When selecting logging


Internal Errors Time Progver this information will be
displayed:

Shows program
See next page, version.
Error buffers in
Logging mode Shows total
run time

INTERNAL LOGGING SELECTION


Display Set-up A Set-up M

(See "Memory")
Display the logging parameters on the
information display see e.g. below:
LOGGING ORI-001 ORB-000 ORB-000
DISPLAY xxx xxx xxx

This logging setup is automatically


stored and shows up next time
internal logging starts.

SET-UP PAR-INH FIELD


Array On 0

Use the Set knob when you want to


Display Parameter Select infor- set the parameters.
name inhibit. mation display Setting PAR-INH (PARameter
("ON or field (0-2) INHibit) to ON prevents the logging
"OFF") display from disappearing if the
Blood Flow knob is touched or a
parameter button (Temp, Cond, etc)
is pressed.

FIELD ARRAY INDEX FORMAT


0 SRI 000 1

Determines position of decimal


The logging setups is
point (or displays in HEX). Not
automatically stored
necessary for S-arrays, see
in SAFERAM.
"Arrays", page 4:28

Select array index (000 - 999).

Select the array to be displayed


(see "Arrays", page 4:27)

In which field the logged


parameter will appear.

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Service Technicians Guide

Error buffers in Logging mode

SELECT LOGGER FACILITY


Internal Errors Time Progver

Select Errors:

Buf: 01 (11)
C COFB 088 043 20 Oct 05 16:37

For more information about the error message


refer to page 4:6 and the Error Code List for
AK 95 S, HCEN 9091.

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Service Technicians Guide

Arrays
Use the set knob to select the array type.

The arrays used for service purpose are:

SRB
SRD
SRI
SRL
SRR
SRW

The different letters stands for:

First letter Second letter Third letter


S=Service R=RAM B=Byte
D=Double Word
I=Integer
L=Logical
R=Real
W=Word

Use the set knob to select arrays and press


to step backwards.

When it is necessary to look at two or three


different arrays at the same time, use the
possibility to choose a separate field on the
information display for each data.

Summary: 1. Set field


2. Set array
3. Set index
4. Push twice to step back
5. Push “display” to see the logged
parameters.

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Maintenance Manual
AK 95 / AK 95 S
October 2006

GAM
BRO

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Maintenance Manual

Preventive maintenance procedures for


AK 95 / AK 95 S

General ........................................................... 5:2

Test equipment ............................................. 5:3

Preventive Maintenance: Base-kit ............ 5:4


Parts ................................................................ 5:4
How to exchange the parts included
in the Base-kit ................................................. 5:5
Actions to carry out after the parts
have been exchanged ...................................... 5:8

Preventive Maintenance: A-kit ............... 5:14


Parts .............................................................. 5:14
How to exchange the exterior parts
included in the A-kit ...................................... 5:15
Actions to carry out after the parts have
been exchanged ............................................. 5:16

Preventive Maintenance: B- and C-kit ... 5:17


Parts .............................................................. 5:17
How to exchange the parts included
in the B- and C-kit ......................................... 5:18
Actions to carry out after the parts have
been exchanged ............................................. 5:20

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Maintenance Manual

General

To ensure proper operation of AK 95 / AK 95 S, Note!


a qualified service technician must perform a All parts in the A-kit are possible to exchange
complete series of preventive maintenance without opening the dialysis machine.
procedures at regular intervals.
The maintenance and calibration information * The contents of the B-kit is the same as the
that you need to use is provided in this manual. contents of the C-kit with one exception;
the C-kit contains complete 2- and 3-way valve
The preventive maintenance procedures have housings instead of separate valve membranes.
been devised to require a minimum of time while Therefore either select the B-kit or the C-kit.
ensuring that the machine is maintained in Select the one that meets your specific need
optimum operation condition. best.

Included in the preventive maintenance proce- When performing preventive maintenance


dures are checks to verify normal machine procedures or calibrations, which require access
operation. Should the machine fail to pass any of to the interior of the machine, you must have
these tests, repair or calibration might be proper electrostatic safety devices (i.e. wrist
needed, then repeat the tests until the specifica- grounding straps or grounding mats) in place to
tions are met. prevent damage to electrostatic sensitive compo-
nents within the machine.
It is mandatory to perform at least a preventive
maintenance every second year.

A yearly maintenance is recommended. The rate


of preventive maintenance might be different
due to variations of the operating environment.

The AK95 / AK 95 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 During repair of any of the parts in the flow
the AK 95 / AK 95 S are void if the equipment is path, special care should be taken and a good
not used in accordance with the instructions hygiene should be kept.
provided. Gambro will not accept responsibility
for any damage or injury resulting from im- Note! After maintenance a disinfection program
proper use or maintenance or unauthorized must be performed before a treatment is per-
repair. formed.

To fulfill the preventive maintenance procedures Checklists are provided in the Spare Parts
for AK 95 / AK 95 S some parts must be ex- Instruction that is included in the maintenance-
changed. The necessary parts to be exchanged kits. The purpose of these checklists is to record
are available in a Base-kit and three complemen- the work done.
tary kits:

• Base-kit (K40182001)

• A-kit (K40179001): Includes exterior parts

• B-kit* (K40180001): Overhauling service-


kit (with separate valve membranes)

• C-kit* (K40181001): Overhauling service-


kit (with complete 2- and 3-way valves)

5:2 AK 95 / AK 95 S HCEN12189 Rev.10. 2006

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Maintenance Manual

Test equipment

Test equipment needed to perform maintenance.

Test equipment: Tolerance: Manufacturer: Gambro Order


number:

Conductivity measurement ± 0.1 mS/cm MESA, IBP


Pressure measurement ± 2mmHg to ± 200mmHg MESA, IBP, Druck
± 1% beyond ± 200mmHg
If BPM is installed:
± 0.8mmHg
Temperature measurement: ± 0.2ºC MESA, IBP
Digital Voltmeter ± 0.5% Fluke
Measuring glass ± 5 ml
Blood leak Calibration N/A Gambro K40169001
Cover
Gauge pin kit for blood pump rollers T = 1.1 (Stop pin = 1.1*2*0.7 = 1.5mm) Gambro K40158001
(including three different pins) T = 1.6 (Stop pin = 1.6*2*0.7 = 2.2mm)
T = 2.0 (Stop pin = 2.0*2*0.7 = 2.8mm)

T = wall thickness of the blood tubing

Gauge pin kit for blood pump rollers T = 1.1 (Stop pin = 1.1*2*0.7 = 1.5mm) Gambro K40158002
(to be ordered separately) T = 1.6 (Stop pin = 1.6*2*0.7 = 2.2mm) K40158003
T = 2.0 (Stop pin = 2.0*2*0.7 = 2.8mm) K40158004

T = wall thickness of the blood tubing

Calibration tube kit N/A Gambro K13983002


Drip chamber N/A
Tube for calibration of N/A
priming detector
Safety tester According to IEC 60601-1 Rigel, Biotec,
Metron
*BPM test equipment N/A Gambro K22151001
*BPM Cuff N/A Gambro 100900141
*pH buffers ± 0.07 pH units pH 7 – 100810001
pH 9 – 100810002

Magnet for blood pump cover Gambro K19049001

* If installed

AK 95 / AK 95 S HCEN12189 Rev. 10. 2006 5:3

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Maintenance Manual Base-kit

Preventive Maintenance: Base-kit

Parts
The Base-kit (K40182001) includes all parts
necessary to fulfill the mandatory preventive
maintenance procedures for AK 95 / AK 95 S.

Base-kit

Monitor Denomination Part No. Qty


AC/DC Air filter, AC/DC K23734001 1
A K 95 S Air filter, cover K12966001 1
AK 95 S Concentrate filter, A and B-connector K16538A 2
AK 95 S O-ring, A and B-connector (male) 100319061 2
AK 95 S O-ring, A and B-connector (female) 100319060 2
AK 9 5 S Level detector, deairating chamber K40136001 1
O-ring, Level guard (deairating
AK 95 S 100319054 1
chamber)
AK 95 S O-ring, degassing chamber (bottom) 100319050 1
AK 9 5 S O-ring, degassing chamber (top) 100319008 1
AK 95 S O-ring, dialyzer connectors 100319009 2
AK 95 S O-ring, ultrafilter holder (for UFD) 100319029 2
AK 95 S Square ring, ultrafilter holder (for UFD) K14920001
1
AK 95 S Sample port for 6 mm tube K20219002 1
AK 95 S Label K24092001 1
M M 95 O-ring, BiCart holder (upper and lower) 100319008 2
MM 95 Concentrate filter, from BiCart holder K16538A 1
MM 95 O-ring, mixing chamber (bottom) 100319050 2
MM 95 O-ring, mixing chamber (top) 100319008 2

Note!
As a complement to the Base-kit, three addi-
tional kits are available; A-, B- and C-kit.

5:4 AK 95 / AK 95 S HCEN12189 Rev.10. 2006

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Base-kit Maintenance Manual

How to exchange the parts included in


the Base-kit

1. First perform a combined heat disinfection 4. Change concentrate filters, K16538A, on


program with CleanCart C or liquid citric the A and B-concentrate connectors.
acid.
Then perform a heat disinfection program
in combination with CleanCart A or a
Chemical disinfection program with sodium
hypochlorite. Refer to the AK 95 or AK 95 S
Operator’s Manual.

5. Change o-rings, 100319061, on the A and


2. Change air filter, K23734001, in the B-concentrate connectors (male).
AC/DC - power supply unit.

100319061

6. Change o-rings, 100319060, O-ring, A- and


3. Change air filter, K12966001, in the cover B-connectors (female)
of AK 95 / AK 95 S.

100319060

05

06
07 10
08 09

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Maintenance Manual

7. Change the level detector, K40136001, in 10. Change the O-rings, 100319029, and
the deairating chamber. square-ring, K14920001 in the ultrafilter
Use the attached o-ring, 100319054. holder. (Only for AK 95 S with UFD-kit)

100319029
K40136001 K14920001

100319054

100319029

8. Change both upper, 100319008, and lower 11. Change the sample port for 6 mm tube,
o-ring, 100319050, in the degassing K20219002.
chamber.

100319008

100319050

12. Change both o-rings, 100319008, in the


9. Change the O-rings, 100319009, in the BiCart holder (upper and lower).
dialyzer connectors.

100319008

100319008

5:6 AK 95 / AK 95 S HCEN12189 Rev.10. 2006

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Maintenance Manual

13. Change concentrate filter, K16538 A, from


the BiCart holder inside the MM 95.

14. Change both upper, 100319008, and lower


o-rings, 100319050, in the mixing
chambers.

100319008

100319050

15. Mark month and year for the next


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

05

06
07 10
08 09

05 10
06 09
07 08

AK 95 / AK 95 S HCEN12189 Rev. 10. 2006 5:7

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Maintenance Manual Base-kit

Actions to carry out after the parts


have been exchanged

1. Check that the screws for the blood pump 8. BPM-test


are tightened. (Both inside the BM and
behind the blood pump rotor) Note!
Following text is valid for machines equipped
2. Check that the screws for the hose clamps with the SunTech blood pressure module
on the water inlet and drain tube are (K24274001). For machines equipped with the
tightened. Colin blood pressure module (K23564001), refer
to HCEN9095, revision 10.2005 for technical and
3. Check that the wheels are tightened. maintenance information about BPM.

4. Perform the Protective Earth Test (PET) 8.1 Test method:


according to instructions available in
HCEN12190, Electrical safety inspections - Attach BPM cuff, 100900141, tight to the
for AK-machines. BPM
test equipment, K22151001.
5. Check the protective earth resistance: - Start the AK 95 S with the main switch
and the ON/OFF button.
Measure between TP 5 (Z0VL) on the - Enter Service mode.
control CPU board and the metal on the - Enter Diagnostics mode.
heater rod. - Select BM, Others, BPM
Measure in MΩ, should be > 1 MΩ. The
machine must be empty and switched off
during measurement. 8.2 BPM sub-tests

Note! Mount the blood monitor on the In the BPM service menu the following sub-tests
fluid monitor. are included:
- Air leakage test: measures that the equipment
6. Erase the error code buffers. Enter service is airtight.
menu > Diagnose > System > Errors > - Inflation speed test: measures the time to fill
Erase. the cuff with air.
- Static pressure: Check of pressure transducer
7. Calibrate the A/D converters for AK 95 S, calibration
see chapter "Calibrations" in the Service
manual. Each of the tests can be carried out separately
but the above order for carrying out the sub-tests
is recommended.

Check that the results from the sub-tests not


exceed following limits:
- Air leakage: maximum 18 mmHg/ 3 min
- Inflation speed: 2 -11 s
- Static pressure: Maximum deviation from
reference to be within ± 3 mm Hg.
50 ± 3 mmHg
150 ± 3 mmHg
250 ± 3 mmHg

5:8 AK 95 / AK 95 S HCEN12189 Rev.10. 2006

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Base-kit Maintenance Manual

8.3 Check of air leakage 8.5 Check of pressure transducer calibration and
measured pressure
By entering this test mode the air leakage for
the BPM module, cuff hose and cuff will be tested By entering this test mode it will be possible to
automatically. check the actual pressure value for the BPM
Before entering the test mode cuff and cuff hose pressure on the AK 95 S display.
to be connected to the AK 95 S.
Cuff to be wrapped tight to the BPM test equip- Before entering the test mode, pressure trans-
ment. ducer calibration tube kit K13983002 to be
connected to the BPM connector. No cuff and
BPM test equipment is used to simulate the cuff hose to be connected.
patient arm circumference. The air leakage is
only tested for 90 sec but the value is recalcu- Note! The pressure transducer calibration tube
lated for 3 minutes. kit must be drained before being connected, to
If the displayed value is above 18 mm Hg / 3 make sure that no fluids or particles enters the
minutes, this indicates that there is a possible BPM connector or tubing's. This might otherwise
air leakage in the system. damage or destroy the sensitive BPM sensors.

It is of course also possible to perform this test When "Measured pressure" is displayed it is
without the cuff and cuff hose connected but then possible to start applying the external reference
the test will only check for air leakage within the pressure.
AK 95 S. In this case replace the cuff and cuff
hose by a tube, which is closed. Note! Pressures shall be applied very carefully
so that no overpressures occur.

8.4 Check of inflation speed To check the actual pressure value, external
pressure reference instrument to be connected
By entering this test mode the capacity for the and external pressure of 250, 150, 50 mm Hg to
pump within the module will be tested automati- be applied. Check deviation from reference
cally. Before entering the test mode cuff and cuff pressure instrument for displayed value.
hose to be connected to the AK 95 S.

Cuff to be wrapped tight to the BPM test equip-


ment. If the displayed time is above 11 seconds,
this test indicates that the pump is worn-out.

AK 95 / AK 95 S HCEN12189 Rev. 10. 2006 5:9

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Maintenance Manual Base-kit

9. Priming detector calibration Use following formula to calculate which


9.1 Start the AK 95 S, enter the Service menu gage pin to use:
and select Calibrations.
2 * wall thickness * 0,7 (mm)
9.2 Select Transducer, External and PRIMING
DETECTOR from the selection diagram. Check the range between the blood pump
rollers and the path according to the
9.3 Press "Select" to start the calibration picture below.
routine.

9.4 Insert an empty tube in the priming


detector and press "Select".
Use the normal tube from the bloodline.

9.5 The calibration is now done automatically


and the calibration factor is written into
the EEPROM.

9.6 When the info. display shows "EEPROM


STORAGE COMPLETED", the calibration
is completed. = Measuring
Adjust range between the blood pump
9.7 Press "Hold" to exit. rollers and the path if it is necessary.

Note! If a technical error is detected, the The GO pin should barely pass within the
calibration must be restarted, or the calibrating area.
priming detector replaced.
The STOP pin is NOT allowed to pass in
10. Measure the power on battery B1 on the any point within the calibrating area.
Protective driver board, exchange if the
value is below 2,6 V (Note! The machine Note! Put grease on the GO and STOP
must be switched on when measuring). pins when not used and store gage in
plastic bag to prevent it from corroding.
11. Control of the blood pump occlusion
Note! The gauge pins can also be ordered
Check surface on the roller at the pump separately:
rotor, if it is damaged exchange the unit. T=1.1 (white) K40158002
The roller unit should easily go back to T=1.6 mm (red) K40158003
upper end position when it has been T=2.0 mm (blue) K40158004
pressed down to end position, exchange
unit if it gets stuck in any position.

Note! If the blood lines have a different


wall thickness, the occlusion of the blood
pump must be adjusted to the right size.

Use the gauge pins (stop/go) available in


the kit K40158001. The kit includes
following three different gauge pins:

T = 1.1 (Stop pin = 1.1*2*0.7 = 1.5mm)


T = 1.6 (Stop pin = 1.6*2*0.7 = 2.2mm)
T = 2.0 (Stop pin = 2.0*2*0.7 = 2.8mm)

T = wall thickness of the blood tubing

5:10 AK 95 / AK 95 S HCEN12189 Rev.10. 2006

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Base-kit Maintenance Manual

12. Enter Service/Calibr/Transducers/ 16. Check the zero level of the three pressure
External/ Arterial pressure transducer. transducers:
- Degassing pressure transducer
12.1 Press "Select" to start calibration routine. - HPG pressure transducer
- Pressure Dialysis, PD
12.2 Make sure that nothing is connected to the
transducer (zero pressure) Note! To reach atmospheric pressure in
the transducer housing, disconnect the
12.3 Check zero level of the Arterial Pressure corresponding tube.
Transducer.
Tolerance: ± 5 mmHg.
Calibrate if necessary (see chapter 17. If installed: Calibrate the pH-sensor with a
calibration for details). buffer solution according to the Calibration
manual.
13. Enter Service/Calibr/Transducers/
External/ Venous pressure transducer 18. Remove the blood leak detector cover and
CPU P. clean the inside of the blood leak housing.

13.1 Press "Select" to start calibration routine. Mount a blood leak calibration cover. Make
sure that the filter is in horizontal posi-
13.2 Make sure that nothing is connected to the tion, start the AK 95 S.
transducer (zero pressure).
Enter the Service menu, select calibration,
13.3 Check zero level of the Venous Pressure transducer, intern and blood leak detector.
Transducer. Place A-pickup tube in concentrate contai-
Tolerance: ± 5 mmHg. ner.
Calibrate if necessary (see chapter
calibration for details). Press "Select" to enter the blood leak
calibration routine.
13.4 Enter Service/Calibr/Transducers/
External/ Venous pressure transducer Note! Let the machine stabilize in
CPU C. conductivity and temperature (37.5 °C) a
few minutes.
13.5 Press "Select" to start calibration routine.
Wait for green fluid path.
13.6 Make sure that nothing is connected to the
transducer (zero pressure). Check the blood leak detector limits 0 and
100 ±10.
13.7 Check zero level of the Venous Pressure Calibrate if necessary (see chapter
Transducer. calibration for details).
Tolerance: ± 5 mmHg.
Calibrate if necessary (see chapter 19. Drain the AK 95 S and replace the blood
calibration for details). leak calibration cover.

14. Enter Diagnose/BM/Pumps and check that 20. Attach pressure reference instrument
the blood pump stops when the cover is before the heater. Use a silicon T.
opened.
Note! Be careful when opening the fluid
15. Start the blood pump and let it run at tubes. Put a piece of paper around the tube
lowest possible speed. Open the blood connector to avoid leakage inside the
pump cover and place a magnet (1) on the monitor.
sensor for the cover. Stop the blood pump
rotor by manually grabbing the handle (2).
Check that the power to the blood pump
motor is switched off within 2 seconds.

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Maintenance Manual Base-kit

21. Start the machine using the following 28. Perform a full calibration of the UF-cell
settings: Suitable mode (Acetate or according to the Service manual.
Bicarbonate) UF
Temperature 37 °C 29. Place the blood monitor on the fluid
Conductivity 14 mS/cm monitor. Let the machine pass Fch.

22. Run the machine for at least 30 minutes 30. Start the heparin pump.
with the fluid passing through the
measuring cell of the Reference Instru- 31. Check the DC leakage between TP 5
ment before continuing with the check of (Z0VL) on the Control CPU board and the
functions and calibrations. Meanwhile, metal on the heater rod. Measure in DC
check the fluid path for air leakages, fluid Voltage, should be < 1 V.
leakages and salt deposits.
32. Place the blood monitor on the sideboard.
23. Adjust the second pressure regulator to
120-125 mmHg, before the heater, 33. Check the DC leakage between TP 5
according to the Service Manual. (Z0VL) on the Control CPU board and the
cover of the suction pump motor. Measure
24. Turn off the power supply main switch. in DC Voltage, should be < 1 V.
Disconnect the silicone T-connector.
34. Check the DC leakage between TP 5
Note! Be careful when opening the fluid (Z0VL) on the Control CPU board and the
tubes. Put a piece of paper around the tube cover of the degassing pump motor.
connector to avoid leakage inside the Measure in DC Voltage, should be < 1 V.
monitor.
35. Check the DC leakage between TP 5
25. Turn on the power supply main switch (Z0VL) on the Control CPU board and the
again and start the AK 95 S. suction pump head. Measure in DC
Voltage, should be < 1 V.
26. Check the conductivity indications, at
approximately 14 mS/cm. 36. Check the DC leakage between TP 5
(Z0VL) on the Control CPU board and the
Use GXL - fluid monitor screen and a degassing pump head. Measure in DC
reference instrument connected to the Voltage, should be < 1 V.
dialysis fluid tubes.

The indicated conductivity values (for


cond.cell P) in GXL should correspond to
the indication on the reference instru-
ment. The maximum deviation is ±0.3 mS/
cm.

27. Check the temperature indications, at


approximately 37 °C.
Use GXL - fluid monitor screen and a
reference instrument connected to the
dialysis fluid tubes.
The indicated temperature value (at the
conductivity cell P) should correspond to
the indication on the reference instru-
ment. The maximum deviation is ±1.5 °C.

If the deviation is more than the stated


tolerance; the affected temperature
transducer must be exchanged.

5:12 AK 95 / AK 95 S HCEN12189 Rev.10. 2006

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Base-kit Maintenance Manual

37. Simulated treatment Note! It is very important to do these things


more or less simultaneously i.e. within seconds.
Note! The following test procedure should Check the residual volume at TIME = 0:00.
preferably not be started or stopped during a Approved residual volume: 100 ml +/- 50 ml
taration of the UF-system. In this case there Repeat the test if smaller deviations appear.
might be a small difference in volume.
Note! All kind of fluid alarms (conductivity etc.)
Simulate a venous pressure of approx. has to be avoided.
50 mm Hg by blocking the pressure port with a
blocked piece of tubing and turning the level 38. Check that the overload protection on the
adjustment knob. heparin pump is working.

Insert the filled venous drip chamber in the air 39. Check the arterial clamp by attaching the
detector. calibration tube set into the arterial clamp.
Enter priming mode and create a level
Press fluid bypass-button (for bypass mode). detector alarm to get the clamp closed.
Apply a pressure of 600 mmHg. Check that
Connect a T-piece to the dialysis tubings. Make the pressure does not fall more than 30
sure that the tubing is long and thin enough to mmHg in 15 seconds.
create a TMP of approx. 200±100 mm Hg during
the simulated treatment. 40. Check the venous clamp by attaching the
calibration tube set into the venous clamp.
Press fluid bypass-button (for direct mode). Enter priming mode and create a level
detector alarm, by lowering the level in
Put the end of the tube in a measuring glass the drip chamber, to get the clamp closed.
placed on the bottom tray. Apply a pressure of 600 mmHg.
Check that the pressure does not fall more
Note! The position of the measuring glass will than 30 mmHg in 15 seconds.
affect the TMP.
41. If installed: Check the battery backup by
Set the blood pump speed to 100 ml/min and disconnecting the mains plug. Let the
start the blood pump. machine run for at least 1 minute.

Set minimum UF-rate to 0.0 l/h. Note! This is not a capacity test of the
backup batteries.
Make sure the measuring glass is filled to 1.00 l
with water of 37.0 °C. 42. Reconnect the mains plug to the outlet
supply of an electrical safety tester.
Set a UF-volume of 0.9 l and treatment time of
1:00 h. Perform the Earth Leakage Test (ELT) and
the Patient Earth Leakage Test (PLT)
Check that the tube to the measuring glass is according to instructions available in
filled with water and all air bubbles are evacu- HCEN12190, Electrical safety inspections
ated. Let the UF-rate stabilize. for AK-machines.

Simulate blood in the priming detector with a 43. Perform heat/chemical disinfection.
piece of paper.

Make sure (again) that the measuring glass is


filled to 1.00 liter.

Press the UF START/STOP button.

AK 95 / AK 95 S HCEN12189 Rev. 10. 2006 5:13

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Maintenance Manual A-kit

Preventive Maintenance: Supplementary A-kit

Parts
The A-kit is designed to be used as a complemen-
tary addition to the Base-kit for the preventive
maintenance procedures of AK 95 / AK 95 S.

The A-kit (K40179001) includes following exterior


parts:

A-kit

Monitor Denomination Part No. Qty


AC/ D C Air filter, AC/DC K23734001 1
A K 95 S Air filter, cover K12966001 1
AK 95 S Connector kit compl. (blue) K40183001 1
AK 95 S Connector kit compl. (red) K40184001 1
AK 95 S Dialyzer tubing kit compl. (blue) K40185001 1
AK 95 S Dialyzer tubing kit compl. (red) K40186001 1
A K 95 S Washer, blood pump rotor K07316001 4
AK 95 S Pick-up tube, A (white) 100850007 1
AK 95 S Pick-up tube, B (blue) 100850008 1
A K 95 S Pick-up tube, (yellow) 100850021 1

Note!
All parts in the A-kit are possible to exchange
without opening the dialysis machine.

5:14 AK 95 / AK 95 S HCEN12189 Rev.10. 2006

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A-kit Maintenance Manual

How to exchange the exterior parts


included in the A-kit

1. Change air filter, K23734001, in the 4. Change the dialyzer tubings complete,
AC/DC - power supply unit. K40185001 (blue) and K40186001 (red).

K40186001

B
K40185001
A A c e ta te

2. Change air filter, K12966001, in the cover 5. Add/change the washers for the blood pump
of AK 95 S. rotors.

K07316001

05

06
07 10
08 09

3. Change the connector kit complete, 6. Change the Pick-up tubes.


K 40183001 (blue) and K 40184001 (red). - Pick-up tube, A (white) 100850007
- Pick-up tube, B (blue) 100850008
- Pick-up tube, (yellow) 100850021

B
A A c e ta te

K40183001
K40184001

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Maintenance Manual A-kit

Actions to carry out after the parts have


been exchanged

1. First perform a heat disinfection program. Check the range between the blood
Refer to the AK 95 or AK 95 S Operator’s pump rollers and the path according to
Manual. the picture below.

2. After the heat disinfection; re-tighten the


nuts of the dialyser connector set to the
machine.

A
B
A c e ta te Nuts

= Measuring

Adjust range between the blood pump


rollers and the path if it is necessary.

The GO pin should barely pass within


the calibrating area.
3. Let the machine pass FCH.
The STOP pin is NOT allowed to pass
4. Control of the blood pump occlusion in any point within the calibrating
area.
Check surface on the roller at the pump
rotor, if it is damaged exchange the unit. Note! Put grease on the GO and STOP
The roller unit should easily go back to pins when not used and store gage in
upper end position when it has been pres- plastic bag to prevent it from corroding.
sed down to end position, exchange unit if
it gets stuck in any position. Note! The gauge pins can also be
ordered separately:
Note! If the blood lines have a different T=1.1 (white) K40158002
wall thickness, the occlusion of the blood T=1.6 mm (red) K40158003
pump must be adjusted to the right size. T=2.0 mm (blue) K40158004

Use the gauge pins (stop/go) available in


the kit K40158001. The kit includes
following three different gauge pins:

T = 1.1 (Stop pin = 1.1*2*0.7 = 1.5mm)


T = 1.6 (Stop pin = 1.6*2*0.7 = 2.2mm)
T = 2.0 (Stop pin = 2.0*2*0.7 = 2.8mm)

T = wall thickness of the blood tubing

Use following formula to calculate which


gage pin to use:

2 * wall thickness * 0,7 (mm)

5:16 AK 95 / AK 95 S HCEN12189 Rev.10. 2006

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B- and C-kit Maintenance Manual

Preventive Maintenance: Supplementary B- and C-kit

Parts Note!
The B- and C-kits are designed to be used as a The contents of the B-kit is the same as the
complementary addition to the Base-kit for the contents of the C-kit with one exception;
preventive maintenance procedures of AK 95 / the C-kit contains complete 2- and 3-way
AK 95 S. valve housings instead of separate valve
membranes. Therefore either select the B-kit
The B-kit, K40180001, and the C-kit, K40181001, or the C-kit. Select the one that meets your
includes following overhaul parts: specific need best.

B-kit

Monitor Denomination Part No. Qty


AK 95 S Arterial pressure line (compl.) K15168001 1
A K 95 S Venous line for level adjustment K19459A 1
AK 95 S Valve house complete, degassing chamber K16952A 1
Valve membranes: AIVA, ZEVA, DIVA,
AK 95 S K08056C 7
BYVA, TAVA, EVVA, FLVA
AK 95 S Santoprene tube (m) 100312141 1
AK 95 S Silicon tube (3x2mm) (m) 100312032 4
AK 95 S O-ring, (Parker coupling to and from INPS) 100335001 4

M M 95 O-ring, (Parker coupling from heat exch.) 100335001 2


M M 95 Spike kit, BiCart holder (lower) K21557006 1
Spike kit, BiCart holder (upper) incl. non
MM 95 K23031004 1
return valve

C-kit

Monitor Denomination Part No. Qty


AK 9 5 S Arterial pressure line (compl.) K15168001 1
AK 95 S Venous line for level adjustment K19459A 1
AK 95 S Valve house complete, degassing chamber K16952A 1

Complete 2-way valves:


AK 95 S K15235A 6
AIVA, ZEVA, DIVA, BYVA, TAVA, EVVA

Complete 3-way valves:


AK 95 S K21139003 1
FLVA
AK 95 S Santoprene tube (m) 100312141 1
AK 95 S Silicon tube (3x2mm) (m) 100312032 4
AK 95 S O-ring, (Parker coupling to and from INPS) 100335001 4

MM 95 O-ring, (Parker coupling from heat exch.) 100335001 2


MM 95 Spike kit, BiCart holder (lower) K21557006 1
Spike kit, BiCart holder (upper)
M M 95 K23031004 1
incl. non return valve

AK 95 / AK 95 S HCEN12189 Rev. 10. 2006 5:17

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Maintenance Manual B-and C-kit

How to exchange the parts included in


the B- and C-kit.

1. Change both the venous and arterial 3b. C-kit only!


pressure monitoring line, including disc Change following complete 2-way valves,
filter. K15235A: AIVA, ZEVA, DIVA, BYVA, TAVA
Arterial line: K15168001 and EVVA.
Venous line for level adjustment: K19459A

K15235A

2. Change the valve house complete, 3c. C-kit only!


K16952A, on the degassing chamber. Change the complete 3-way valve,
K21139003, for FLVA..

K21139003

3a. B-kit only! 4. Change all the Santoprene tubes in the


Change valve membranes, K08056C, fluid monitor.
for following valves: AIVA, ZEVA, DIVA,
BYVA, TAVA, EVVA and FLVA.
See instructions on page 5:20.

5:18 AK 95 / AK 95 S HCEN12189 Rev.10. 2006

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B- and C-kit Maintenance Manual

5. Change all the Silicone tubes in the fluid 8. Change both the upper and the lower
monitor. spike kit in the BiCart-holder.
• K23031004 (Upper)
• K21557006 (Lower)

Assemble according to machine


configuration.

6. Change the o-rings, 100335001, in the


parker couplings to and from INPS.

100335001

100335001

7. Change the o-rings, 100335001, in the


parker couplings from the heat exchanger.

AK 95 / AK 95 S HCEN12189 Rev. 10. 2006 5:19

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Maintenance Manual B-and C-kit

Replacing valve membranes


Correct assembly procedure of the housing and •Tighten the screws with a torque of
membrane is essential for proper function and approximatly 0,7 Nm. Make sure that self-
preventing future leaks. locking nuts are used.

• Place the membrane in the valve housing with Note! Do not overtighten the screws, this will
the seam on the periphery of the silicone deform the valve housing and cause leakage.
membrane facing from the magnet of the valve.

Valve mounting tool K15391C


A special service tool for mounting of the valve
membrane correctly in the valve housing is
available.

5:20 AK 95 / AK 95 S HCEN12189 Rev.10. 2006

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B- and C-kit Maintenance Manual

Actions to carry out after the parts have


been exchanged

1. First perform a heat disinfection program.


Refer to the AK 95 or AK 95 S Operator’s
Manual.

2. Let the machine pass FCH.

AK 95 / AK 95 S HCEN12189 Rev. 10. 2006 5:21

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Maintenance Manual

This page is intentionally left blank

5:22 AK 95 / AK 95 S HCEN12189 Rev.10. 2006

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HCEN12189 © Gambro Lundia AB,1996, 2001. Revision October 2006

Gambro Lundia AB, Monitor Division


Box 10101
SE-220 10 Lund
Sweden

Tel:+46 46 16 90 00
Fax:+46 46 16 96 96
www.gambro.com

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Calibrations

6. Calibrations

Contents
Calibrations
Technical Facilities ..................................... 6:2
Before calibration ........................................ 6:2

A/D Converters
A/D Converters ........................................... 6:3

Transducers
Calibration of linear transducers ............... 6:4
Selection diagram .................................. 6:4
Venous Pressure Transducer Calibr ...... 6:5
Arterial Pressure Transducer Calibr .... 6:6
Priming Detector calibration ................. 6:7
Occlusion adjustment, blood pump ....... 6:7
Blood Leak Detector calibration ............ 6:8
Conductivity Transducer calibration .... 6:9
Dialysis Pressure Transd Calibr ......... 6:10
Degassing Pressure Transd Calibr ...... 6:11
pH transducer calibration ................... 6:12
Pressure Regulator Calibr, PR 1 ......... 6:14
Pressure Regulator Calibr, PR 2 ......... 6:14
HPG Pressure Transducer Calibr ........ 6:15
Variable flow calibration ...................... 6:16

UF Calibration ....................................... 6:17


General ................................................. 6:17
Complete .............................................. 6:18
Intern .................................................... 6:19
Verify .................................................... 6:20

BPM test .................................................. 6:21

AK 95 / AK 95 S Service Manual 6:1


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Calibrations

Calibration AK 95 S
Warning! After completing the calibrations, the conductivity value must always be confirmed by the
hospital laboratory.

Technical Facilities Before calibration


The following instructions are based on the
To get information about the use of the
availability of some technical facilities, listed
control buttons, read chapter 4; Service
below.
Technicians Guide.

Ordering no:
UF - calibration:
UF-calibration box K21908002

AD:
Digital voltmeter

Priming detector:
A piece of blood tube used at the hospital.

Blood leak detector


Calibration cover K40169001

Pressure
Reference instrument 300333001
Calibration kit K13983002

Special tool
For silicone tube connectors K12755001

Calibration kit

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Calibrations

AD Converters
1. Start the AK 95 S, enter the Service menu 5. Set the “AD REF VOLTAGE” on the
and select Calibrations. display to the value shown on the voltme-
ter and press .
2. Choose AD-converter.

When selecting “AD-Converter” from the display


START
6. Press UF to load the value into the
with the SET knob and press key following STOP

display appears: EEPROM.

SELECT AD-CONVERTER
CPU X AD-REF VOLTAGE STORED
CPU-C CPU-P CPU-W MM95

3. Select an AD-converter with the SET knob


7. Press to exit.
and press key.

CPU X AD LOW REF SET HIGH


xx.xx mV xx.xx xx.xx xx.xx

4. Measure the voltage (using a 4.5 digit


voltmeter), between following testpoints or
across the resistor:

CPU Testpoint Ref Tetspoint Circuit board Limits (mV)

CPU-C TP 6 TP 5 Control Driver board 45.00 - 55.00


CPU-P TP 1 TP 2 Protective Driver board 45.00 - 55.00
CPU-W TP 3 TP 4 Protective CPU board 4500 - 5500
MM 95 R 24 R 24 MM I/O board 45.00 - 55.00

CPU C driver board AD ref voltage range:


45.00 to 55.00 mV
AD ref voltage range:
45.00 to 55.00 mV PVREF
TP1

TP 5 TP2
Z0VAD
CPU C A/D ref

TP 6 Buzzer

AD ref voltage range:


4.500 to 5.500 V

TP3 MM I/O AD ref voltage range:


WREF 45.00 to 55.00 mV

(TP1)
CPU W PROM (TP2)
TP4 R24
Z0VRW
CPU W
SafeRAM
pH plug

AK 95 / AK 95 S Service Manual 6:3


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Calibrations

Transducers
Calibration of linear
transducers
1. Start the AK 95 S, enter the Service • Select Internal and the AK 95 S main-
menu and select Calibrations. tains a flow during the calibration.

2. Choose Transducers Independently wich flow support is chosen


the Selection diagram turns up.
3. Follow the instructions for each
calibration. 4. When turning the SET knob all the
different transducers that are possible to
• Select Extern for no flow calibrate will “scroll” on the Information
(pumps stopped). display.

Selection diagram

VENOUS PRESSURE TRANSDUCER CPU P Run Time Meter

VENOUS PRESSURE TRANSDUCER CPU C pH TRANSDUCER

ARTERIAL PRESSURE TRANSDUCER HPG PRESSURE TRANSDUCER

PRIMING DETECTOR DEGASSING PRESSURE TRANSDUCER

BLOOD LEAK DETECTOR DIALYSIS PRESSURE TRANSDUCER

CONDUCTIVITY A TRANSDUCER CONDUCTIVITY A B P TRANSDUCERS

CONDUCTIVITY B TRANSDUCER CONDUCTIVITY P TRANSDUCER

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Calibrations

Venous Pressure Transducer Calibration VEN PR LOW REF SET HIGH


1.2 -550 +500 550
1. Connect the Gambro reference instrument
(together with a calibration tube set) to 11. Set the “REF SET” value on the AK 95 S
the venous pressure transducer on the to the reading on the reference instrument
front of the AK 95 S, see fig. below.
and press .
2. Zeroset the reference instrument, wait for
stable reading. 12. Press
START
UF to load the calibration values
STOP

3. Start the AK 95 S, enter the Service into the EEPROM.


menu and select Calibrations.
13. When the EEPROM storage is ready,
4. Select Transducers, External and press to exit.
VENOUS PRESSURE TRANSDUCER
CPU P from the selection diagram. Continue with the venous pressure transducer
calibration for CPU C.
5. Press to confirm the selected trans- Follow this instruction except for paragraph 4,
where VENOUS PRESSURE TRANSDUCER
ducer.
CPU C shall be selected instead of CPU P.
6. Apply zero pressure by opening the three
If a calibration error occurs:
clamps A, B and C on the calibration tube
set. Set the “REF SET” value on the
AK 95 S to 0 mmHg. • Try to do the calibration again.

• If the error occurs a second time:


7. Press to enter the setting. Change the transducer and the transducer
board.
START Report to your Gambro service representa-
8. If the lit UF key is pressed at this time
STOP
tive the error message on the error dis-
the machine stores the offset for the play.
transducer in the EEPROM and updates
the checksum.

For the sensitivity calibration


(the slope):
Close clamp A. Apply a pressure of approx.
-500 mmHg, shown on the reference in-
strument. Close clamp B.

VEN PR LOW REF SET HIGH


1.2 -550 +500 550

9. Set the “REF SET” value on the AK 95 S


to the reading on the reference instrument
and press twice.

10. Open clamp A and B, then close clamp A


again. Apply a pressure of approx. +500 C
mmHg, shown on the reference instru-
ment. Close clamp B. B

AK 95 / AK 95 S Service Manual 6:5


HCEN 9138 Rev. 10.2005

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Calibrations

Arterial Pressure Transducer Calibration


1. Connect the Gambro reference instrument ART PR LOW REF SET HIGH
(together with a calibration tube set) to 1.2 -550 +500 550
the arterial pressure transducer on the
front of the AK 95 S, see fig. below. 11. Set the “REF SET” value on the AK 95 S
to the reading on the reference instrument
2. Zeroset the reference instrument, wait for
stable reading. and press .

3. Start the AK 95 S, enter the Service START


12. Press UF to load the calibration values
menu and select Calibrations. STOP

into the EEPROM.


4. Select Transducers, External and
ARTERIAL PRESSURE TRANSDUCER 13. When the EEPROM storage is ready,
from the selection diagram. press to exit.

5. Press to confirm the selected trans-


ducer.
If a calibration error occurs:
6. Apply zero pressure by opening the three
clamps A, B and C on the calibration tube • Try to do the calibration again.
set. Set the “REF SET” value on the
AK 95 to 0 mmHg. • If the error occurs a second time:
Change the transducer and the transducer
board.
7. Press to enter the setting. Report to your Gambro service representa-
tive the error message on the error dis-
8. If the lit
START
UF key is pressed at this time play.
STOP

the machine stores the offset for the


transducer in the EEPROM and updates
the checksum.

For the sensitivity calibration


(the slope):
Close clamp A. Apply a pressure of approx.
-500 mmHg, shown on the reference in-
strument. Close clamp B.

ART PR LOW REF SET HIGH


1.2 -550 -500 550

9. Set the “REF SET” value on the AK 95 S


to the reading on the reference instrument
and press twice.
C
10. Open clamp A and B, then close clamp A
again. Apply a pressure of approx. +500 B
mmHg, shown on the reference instru-
ment. Close clamp B.

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Calibrations

Priming Detector calibration Occlusion adjustment, blood pump/


1. Start the AK 95 S, enter the Service infusion pump
menu and select Calibrations.
Check surface on the roller at the pump rotor, if
2. Select Transducer, External and it is damaged exchange the unit. The roller unit
PRIMING DETECTOR from the selection should easily go back to upper end position when
diagram. it has been pressed down to end position, ex-
change unit if it gets stuck in any position.
3. Press to start calibration routine.
Note! If the blood lines/infusion lines have a
different wall thickness, the occlusion of the
4. The display shows: blood pump must be adjusted to the right size.

INSERT TUBE Use the gauge pins (stop/go) available in the kit
Press SELECT to confirm K40158001. The kit includes following three
different gauge pins:
5. Insert an empty tube in the priming
T = 1.1 (Stop pin = 1.1*2*0.7 = 1.5mm)
detector and press .
T = 1.6 (Stop pin = 1.6*2*0.7 = 2.2mm)
Use the normal tube from the blood line. T = 2.0 (Stop pin = 2.0*2*0.7 = 2.8mm)

6. The calibration is now done automatically T = wall thickness of the blood tubing
and the calibration factor is writen into
the EEPROM. Use following formula to calculate which gage
pin to use:
7. When the info. display shows “EEPROM 2 * wall thickness * 0,7 (mm)
STORAGE COMPLETED”, the calibration
is completed.

8. Press to exit.

If an technical error is detected, the calibration


must be restarted, or the priming detector
Check the range between the blood pump rollers
replaced.
and the path according to the picture below.
Adjust range between the blood pump rollers and
the path if it is necessary.

The GO pin should barely pass within the cali-


brating area.

The STOP pin is NOT allowed to pass in any


point within the calibrating area.

Note! Put grease on the GO and STOP pins


when not used and store gage in plastic bag to
prevent it from corroding.

= Measuring

AK 95 / AK 95 S Service Manual 6:7


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Calibrations

Blood Leak Detector calibration


1. Make sure there is no fluid in the AK 95 S If a calibration error occurs:
Monitor. If fluid in the monitor, press
Rinse/Drain. • Check the position of the calibration filter
and repeat from point 1.
2. Remove the blood leak detector cover and
clean the inside of the blood leak housing. • If an error occurs after the 2nd try, change
the blood leak detector.
3. Mount a blood leak calibration cover
(K40169001), make sure that the filter is in • After calibration, clean the filter with
horisontal position . water.
Start the AK 95 S, wait until buzzertest is Replace the filter when it has been used
done and bargraphs are lit. for more than 10 times.

4. Start the AK 95 S, enter the Service


menu and select Calibrations.

5. Select Transducer, Intern and


BLOOD LEAK DETECTOR from the
selection diagram.

6. Place A-pickup tube in the acetate-


concentrate container.

7. Press to enter the Blood leak calibra-


tion routine.
Let the machine stabilize in conductivity
and temperature (37.5 °C) a few minutes.
Wait for green fluid path.

8. Make sure the filter is in horizontal


position and set “REF SET” to 0.

9. Press when the BL LEAK value is


stable.

10. Turn the calibration filter to vertical


position and set “REF SET” to 100.

11. To continue, press twice when the


BL LEAK value is stable.

START
12. Press UF
STOP
to store the calibration values.

13. Wait until the display shows “EEPROM


STORAGE COMPLETED”.

14. Press to exit.

15. Drain the AK 95 S and remount the


standard blood leak cover.

6:8 AK 95 / AK 95 S Service Manual


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Calibrations

Conductivity Transducer calibration


The calibration is a “two point calibration”. The 5. Place A-pickup tube in the concentrate
two points are 0.0 mS/cm (RO-water) and container. The AK 95 S will now regulate
14.0 mS/cm (with concentrate). conductivity to approx. 14 mS/cm. The
green fluid path must be lit.
NOTE!
Make sure the +500ml/min restrictor is mounted 6. Let the conductivity stabilize for 20 min-
before calibration. utes. (green fluid path)
Press “TEMP” to check that temperature
NOTE! is 37,5°C.
• Before conductivity calibration, Chemical Press to get back the conductivity
cleaning must be performed, one with Citric acid
calibration display.
and one with Hypochlorite.
7. Set the “REF. SET” value on the AK 95 S
1. Enter the Service menu, Calib, Transd
display to the same value shown on the
and select Intern.
reference instrument.
Set the display at the conductivity trans-
ducer to be calibrated.
The possible cond. cell calibrations are: 8. Press to enter the value.
• CONDUCTIVITY A TRANSDUCER
• CONDUCTIVITY B TRANSDUCER 9. The machine will now ask you to confirm
• CONDUCTIVITY P TRANSDUCER to enter sensitivity calibration.
• CONDUCTIVITY ABP TRANSDUCERS
Press to confirm.
2. Connect the Gambro reference instrument
to the dialyzer connectors. To exit: press (will stop calibration).
Connect both the A- and B-pickup tubes to
the MM 95. START
10. Press UF
STOP
to load the calibration values
Set the temperature to 37,5°C (by pressing into the EEPROM.
TEMP key) and let the AK 95 S and the refer-
ence instrument stabilize for at least 30 min- All the transducers A, B and P are all calibrated
utes. in this way.

Make sure that the machine is not in bypass, i.e.


the fluid bypass button is not lit. There must
be flow through the measuring cell.

3. Press to enter the calibration routine.

4. Wait until the reading on the reference


instrument has stabilized at 0.0 mS/cm.
Set REF SET to 00.0 with Set knob.

Press “TEMP” and check that the tem-


perature is 37,5°C.
Press to get back the conductivity
calibration display.
Press to enter the value.

AK 95 / AK 95 S Service Manual 6:9


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Calibrations

Dialysis Pressure Transducer Calibration


START
1. Disconnect tube no. 46, 20 and the silicone 14. Press UF
STOP
to load the calibration values
tube at the deairating chamber see fig. into the EEPROM.
below.
15. When the EEPROM storage is ready,
2. Plug the two lower silicone connectors at
the deairating chamber. Use two plugs press to exit.
from the calibration kit, see fig. below.

3. Connect the Gambro reference instrument If a calibration error occurs:


to the silicone connector on the top of the
deairating chamber via the calibration • Try to do the calibration again.
tube set. See fig. below.
• If the error occurs a second time:
4. Zeroset the reference instrument, wait for Change the transducer and the transducer
stable reading. board.
Report to your Gambro service representa-
5. Start the AK 95 S, enter the Service tive the error message on the error dis-
menu and select Calibrations. play.

6. Select Transducer, External and


DIALYS PRESSURE TRANSDUCER
from the selection diagram.

7. Press to confirm the selected trans-


ducer.

8. Apply zero pressure by opening the two


clamps A, and B on the calibration tube
set. Set the “REF SET” value on the
AK 95 S to 0 mmHg.

9. Press to enter the setting.

10. Close clamp A. Apply a pressure of approx.


-500 mmHg, shown on the reference
instrument. Close clamp B.

11. Set the “REF SET” value on the AK 95 S


to the reading on the reference instrument
and press twice.

12. Open clamp A and B, then close clamp A


again.
Apply a pressure of approx. +500 mmHg,
shown on the reference instrument. Close
clamp B.

13. Set the “REF SET” value on the AK 95 S


to the reading of the reference instrument
and press .

6:10 AK 95 / AK 95 S Service Manual


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Calibrations

Degassing Pressure Transducer Calibration


1. Disconnect tube no. 50 at the Expansion 13. Set the “REF SET” value on the AK 95 S to
chamber. Connect the Gambro reference the reading on the reference instrument
instrument to tube no. 50 via the calibra-
and press .
tion tube set. Use the angled-silicone
connector from the calibration kit.
START
14. Press to load the calibration values
UF
STOP
2. Disconnect tube no. 11 at the degassing
into the EEPROM.
chamber or at the outlet of the flow pump
and plug the silicone connector. Use a plug
15. When the EEPROM storage is ready,
from the calibration kit.
press to exit.
4. Zeroset the reference instrument, wait for
stable reading.
If a calibration error occurs:
5. Start the AK 95 S, enter the Service
menu and select Calibrations. • Try to do the calibration again.

6. Select Transducer, External and • If the error occurs a second time:


DEGASSING PRESSURE TRANSDUCER Change the transducer and the transducer
from the selection diagram. board.
Report to your Gambro service representa-
7. Press to confirm the selected trans- tive the error message on the error dis-
play.
ducer.

8. Apply zero pressure by opening the two


clamps A and B on the calibration tube to tube 50
set. Set the “REF SET” value on the
AK 95 S to 0 mmHg.

9. Press to enter the setting.

10. Close clamp A. Apply a pressure of approx.


-500 mmHg, shown on the reference
instrument. Close clamp B.

11. Set the “REF SET” value on the AK 95 S


to the reading o the reference instrument
and press twice .

12. Open clamp A and B, then close clamp A


again.
Apply a pressure of approx. +500 mmHg,
shown on the reference instrument. Close
clamp B.

AK 95 / AK 95 S Service Manual 6:11


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Calibrations

pH transducer calibration

Calibration should be performed on a regular 7. Put the pH sensor in a cup with pH 7


basis to ensure optimum performance. buffer solution (ordering no. 100 810 001)
which must cover the glass membrane i.e.
A complete calibration procedure consists the level in the cup should be at least
of the following steps: 30mm from the bottom.

1. Offset calibration, with a buffer solution 8. Stir in order to achieve balance in the
(a solution with a very accurate and stable buffer solution. Do not let the pH sensor
pH-value) having a pH-value in the range lean against the bottom of the cup.
of pH 6.5-7.5, followed by: Wait for 2 minutes.

2. Slope calibration with a buffer solution 9.* Press to set the “REF SET” value on
having pH-value that differs at least 2 pH-
the AK 95 S and wait until the calibration
units from the buffer used for offset cali-
bration. display returns.

START
Calibration schedule: 10. Press UF
STOP
to load the calibration value
into the EEPROM.
An Offset calibration should be per-
formed after one month in operation and 11. Clean the pH-sensor in RO-water.
then every third month to verify the Remount the pH sensor into the
performance. pH sensorhousing.

A Complete calibration procedure


should be performed at installation and
then every 12 months.

Offset Calibration:

1. Make sure there is no flow or fluid in the


AK 95 S. The inlet water must be closed.

2. Start the AK 95 S, enter the Service


menu and select Calibrations.

3. Select Transducer, External and


pH TRANSDUCER from the selection
diagram.

4. Press to start calibration routine.

5. Remove the pH sensor from the pH sensor


housing by loosening the nut holding the
pH sensor and rinse the sensor in distilled
water.

6. Check that the “REF SET” on the AK 95 S


displays pH 7.

6:12 AK 95 / AK 95 S Service Manual


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Calibrations

Complete calibration:

1. Make sure there is no flow or fluid in the 13. Stir in order to achieve balance in the
AK 95 S. The inlet water must be closed. buffer solution. The pH sensor must not
lean against the bottom of the cup.
2. Start the AK 95 S, enter the Service Wait for 2 minutes.
menu and select Calibrations.
14.* Press and wait.
3. Select Transducer, External and
pH TRANSDUCER from the selection The display shows: Entering sensitivity
diagram. calibration.

4. Press to start calibration routine. 15. Press to confirm that the calibration
shall continue.
5. Remove the pH sensor from the pH sensor
housing by loosening the nut holding the 16. When the calibration display returns,
pH sensor and rinse the sensor in distilled press
START
UF
STOP
to load the calibration values
water.
into the EEPROM.
6. Check that the “REF SET” on the AK 95 S
17. Remount the pH-sensor into the pH sensor
displays pH 7.
housing.
7. Put the pH sensor in a cup with pH 7
* If an error message is shown after this
buffer solution (ordering no. 100 810 001),
step, check the buffer solutions, level in
or whatever reference solution available,
the cup and repeat the procedure from
which must cover the glass membrane i.e.
step 1. If there still is an error after 2nd
the level in the cup should be at least
try, replace the pH-sensor.
30mm from the bottom.
NOTE! The pH-sensor should be changed every
8. Stir in order to achieve balance in the
eighteen month.
buffer solution. Do not let the pH sensor
lean against the bottom of the cup.
Wait for 2 minutes.

9.* Press to set the “REF SET” value on


the AK 95 S and wait until the calibration
display returns.

10. Rinse the pH sensor in distilled water.

11. Check that the “REF SET” on the AK 95 S


displays pH 9.

12. Put the pH sensor in a cup with pH 9


buffer solution (ordering no. 100810002)
which must cover the glass membrane i.e.
the level in the cup should be at least
30mm from the bottom.

AK 95 / AK 95 S Service Manual 6:13


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Calibrations

Pressure Regulator Calibration, PR 1 Pressure Regulator Calibration, PR 2

1. Connect a pressure gauge just before the 1. Disconnect tube no. 4 from the T-connector
Parker connector inside MM 95 according at INVA.
to this picture.

PR 1

2. Install a T-connector in series with the prior.


Connect tube no.4 and the reference instru-
ment to it. Use nipple K0 1515 002 to the
reference instrument connection.
2. Start the AK 95 S.
3. Zeroset the Reference instrument, wait for
3. Perform a functional check and wait until stable reading.
the conductivity and the temperature are
stable. The fluid path on the OP-panel 4. Start the AK 95 S.
must be green before the calibration
begins. 5. Perform a functional check and wait until
the conductivity and the temperature are
4. Adjust the pressure regulator, PR 1, until stable. The fluid path on the OP-panel must
the pressure measured at the pressure be green before the calibration begins.
gauge is 600 mmHg ±75 mmHg.
6. Adjust the pressure regulator, PR 2, until
5. Perform a Drain. the pressure measured at the reference
instrument is 130 mmHg ± 10 mmHg.
6. Disconnect the pressure gauge.
7. Perform a Drain.

8. Reassemble to the normal silicone


T-connector.

Fluid connector
detection

Safety by-pass SAGS


P
Unit
REVA Treg
INPS P Heater T

Water
Inlet Pressure PR 2 INVA
regulator Flow
PR 1 °C switch
AIVA

Heat Suction
exchanger Pump
Drain

Outlet
Restrictor

AK 95 S Inlet/Outlet Flow Diagram. The complete


Flow Diagram is showed at page 2:5.

6:14 AK 95 / AK 95 S Service Manual


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Calibrations

HPG Pressure Transducer Calibration


1. Disconnect tube no. 23909 at the HPG 15. When the EEPROM storage is ready,
pressure transducer, see fig. below. press to exit.

2. Plug the left side of the HPG pressure


transducer. Use a plug and a stright silicon
If a calibration error occurs:
connector from the calibration kit.
• Try to do the calibration again.
3. Connect the Gambro reference instrument
to the right side of HPG pressure trans-
• If the error occurs a second time:
ducer via the calibration tube set.
Change the transducer and the transducer
board.
4. Zeroset the reference instrument, wait for
Report to your Gambro service representa-
stable reading.
tive the error message on the error dis-
play.
5. Start the AK 95 S, enter the Service
menu and select Calibrations.

6. Select Transducer, External and


HPG PRESSURE TRANSDUCER
from the selection diagram.

7. Press to confirm the selected trans-


ducer.

8. Apply zero pressure by opening the two


clamps A and B on the calibration tube 1
set. Set the “REF SET” value on the 2
AK 95 S to 0 mmHg.

9. Press to enter the setting.

10. Close clamp A. Apply a pressure of approx.


-500 mmHg, shown on the reference
instrument. Close clamp B.

11. Set the “REF SET” value on the AK 95 S


to the reading on the reference instrument
and press twice.

12. Open clamp A and B, then close clamp A


again. Apply a pressure of approx. +500
mmHg, shown on the reference instru-
ment. Close clamp B.

13. Set the “REF SET” value on the AK 95 S


to the reading of the reference instrument
and press .
START
14. Press to load the calibration values
UF
STOP

into the EEPROM.

AK 95 / AK 95 S Service Manual 6:15


HCEN 9138 Rev. 10.2005

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Calibrations

Variable flow calibration

This calibration will set the number of steps


needed to obtain a flow of 500 ml/min.
This value will then be used during functional
check and when entering service mode as the
flow always should be 500 ml/min in functional
check and service mode.

1. Start the AK 95 S, enter the Service menu


and select Calibrations.

2. Place A-pickup tube in the concentrate


container.

3. Select Other / Variable flow to initiate the


calibration.

Note: If variable flow is not installed following


attention will be displayed:

VARIABLE FLOW IS NOT INSTALLED


Check preset

4. Following text will be displayed during the


calibration:

STEPS: XXX FLOW: ---- ml/min


Please wait. Press HOLD to abort

STEPS: the position of the stepper motor


FLOW: the average dialysis flow

5. When the AK 95 S machine has found a


new calibration value it will automatically
store the value in the Safe-RAM.
Following text will automatically appear:

ADJUSTING VARIABLE DIALYSIS FLOW


Please wait XX seconds

6. At the end of the calibration the new


calibration data is displayed:

VAR. FLOW MOTOR POSITION STORED


NEW VALUE: XXX OLD VALUE: YYY

7. Press HOLD to finish the calibration.

Note: During this calibration it is possible to


supervise the conductivity and temperature.

6:16 AK 95 / AK 95 S Service Manual


HCEN 9138 Rev. 10.2005

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Calibrations

UF Calibration
General
This section describes the calibration routine of The Complete calibration routine is done with
the UF-measuring unit. the mainflow 500 ml/min. It requires that the
external UF calibration equipment is connected
The UF-measuring unit consists of two flow to the AK 95 S, see fig.below. The equipment
measurement channels called channel 1 (CH 1) contains a reference volume, a flow directing
and (CH 2). CH 1 is the channel used to measure valve (UFVA) and a UF- calibration box. The
the main flow to the dialyser and CH 2 is used to UF calibration box controls the directing valve
measure the flow from the dialyzer, i.e. the sum by measuring low level and high level of the
of the main flow and the UF flow. The UF flow is reference volume and depending on the selected
the difference between CH1 and CH2 flows. UF UF box mode the valve will become closed or
flow is also called differential flow. opened when low or high level is detected.

Perform both a disinfection and a cleaning UF calibration equipment, ordering no.


decalcification to remove both organic and K2 1908 002
calcium precipitates, according to the AK 95 S
Operator’s Manual. Note! Tubes used to connect the reference
volume to the monitor should not be longer than
The calibration routine can be run in 3 different standard tubes used for connection of dialysers.
modes. The modes are Complete, Intern and The connection tubes should be routed so that
Verify. “air traps” are avoided.

- Select Complete for an automatic UF Note!


calibration. Make sure the +500ml/min restrictor is mounted
before calibration.
- Select Intern for an internal calibration
(taration but updating the EEPROM instead of
RAM). This is done without the external UF
calibration equipment connected to the
AK 95 S.
It is not possible to select Intern if not a
complete UF calibration has been done on the
UF cell before.

- Select Verify for a verification of the result


from the latest calibration.

High Level
AK
AK9590
S

V.ref.

UF
Low Level Cal.
Flow in/out Box
UFVA

Fig. The AK 95 S UF calibration system.

AK 95 / AK 95 S Service Manual 6:17


HCEN 9138 Rev. 10.2005

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Calibrations

Complete

Turn on the equipment on the following During the UF-calibration:


order: The time display shows the time since the
calibration was started.
1. Plug in the UF calibration box.
The information displays also shows the different
Note! All electrical connections must be done stages during the calibration:
before the power for AK 95 S is turned on. • Fluid preparation
Be aware of that there is no main switch on the • UF stabilization
UF calibration box. • Main flow offset calibration
• CH 1 flow calibration
Connect the UF calibration box to the • Differential flow calibration
AK 95 S. • Verifying calibration of UF
• Verifying calibration of Isolated UF
Use the UF calibration cable, K1 4036, to
connect the AK 95 S with the UF calibration When the automatic UF calibration is
box. The part of the cable that is labeled UF ready:
BOX should be connected to the UF calibration After the calibration AK 95 S continues to store
box. the calculated values. When the storage is
completed, the verification results are displayed.
Note! The complete calibration will not run
(but nothing will get destroyed) if the cable is First the display for UF Volume for 3 seconds:
reversed.
UF VOL REF VOL VOL DIFF
2. Start the AK 95 S with the main switch and 1006.5 1007.3 -0.28 %
the ON/OFF button.

3. Place B-pickup tube in the acetate-concentrate Then the display for Isolated UF Volume for 3
container. seconds:

4. Enter Service mode. ISO VOL REF VOL VOL DIFF


1007.5 1007.3 +0.28 %
5. Connect the fluid tubes to the UF calibration
box.
Then the previous disply is showed again for
3 seconds and so on.
6. Select Calibration.

7. Select Transducers. When ready, press to exit the Complete UF


calibration.
8. Select UF.
Note! Perform a Rinse before leaving the
9. Select Complete. AK 95 S.

10. Set Reference volume with the SET knob. The equipment is turned off in the
(The Referense volume is labeled on the UF- following order:
Calibration unit) 1 AK 95 S ON/OFF button.
2 AK 95 S main switch.
11. Press to confirm. 3 UF calibration box.

After the Reference volume is confirmed the UF


calibration runs automatically, until the
calibration is finished.

6:18 AK 95 / AK 95 S Service Manual


HCEN 9138 Rev. 10.2005

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Calibrations

Intern

1. Start the AK 95 S with the main switch and When the internal UF calibration is ready:
the ON/OFF button. After the calibration, AK 95 S displays:

2. Place B-pickup tube in the acetate-concentrate INTERNAL UF CALIBRATION READY


container.
SELECT for info, HOLD to save
3. Enter Service mode.

4. Select Calibration. Press to show more information.

5. Select Transducers.
Press to save the calibrations values.
6. Select UF.
When the storage is completed, AK 95 S displays:
7. Select Intern.
EEPROM STORAGE COMPLETED
The internal UF calibration runs automatically,
until the calibration is finished.
Press HOLD to exit

When ready, press to exit the internal UF


calibration.

Note! If the machine is equipped with a UFDkit,


change preset (1-26 UFD) to ”not inst” before
entering calibration mode.

AK 95 / AK 95 S Service Manual 6:19


HCEN 9138 Rev. 10.2005

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Calibrations

Verify

Turn on the equipment on the following The information displays also shows the different
order: stages during the calibration:
• Fluid preparation
1. Plug in the UF calibration box. • UF stabilization
• Main flow offset calibration
Note! All electrical connections must be done • CH 1 flow calibration
before the power for AK 95 S is turned on. • Differential flow calibration
Be aware of that there is no main switch on the • Verifying calibration of UF
UF calibration box. • Verifying calibration of Isolated UF

Connect the UF calibration box to the When the verification of the UF cell
AK 95 S. calibration is ready:
When the verification is completed, AK95
Use the UF calibration cable, K1 4036, to displays the results:
connect the AK 95S with the UF calibration box.
The part of the cable that is labeled UF BOX First the display for UF Volume for 3 seconds:
should be connected to the UF calibration box.
UF VOL REF VOL VOL DIFF
Note! The verification will not run (but nothing 1006.5 1007.3 -0.28 %
will get destroyed) if the cable is reversed.

2. Start the AK 95 S with the main switch and Then the display for Isolated UF Volume for 3
the ON/OFF button. seconds:

3. Place B-pickup tube in the acetate-concentrate ISO VOL REF VOL VOL DIFF
container.
1007.5 1007.3 +0.28 %
4. Enter Service mode.
Then the previous display is shown again in
3 seconds and so on.
5. Connect the fluid tubes to the UF calibration
box.
When ready, press to exit the verification of
6. Select Calibration. the UF cell calibration.

7. Select Transducers. Note! Perform a Rinse before leaving the


AK 95 S.
8. Select UF.
The equipment is turned off in the
9. Select Verify. following order:
1 AK 95 S ON/OFF button.
10. Set Reference volume with the SET knob. 2 AK 95 S main switch.
(The Referense volume is labeled on the UF- 3 UF calibration box.
Calibration unit)

11. Press to confirm.

After the Reference volume is confirmed the


verification of the UF cell calibration runs
automatically.

6:20 AK 95 / AK 95 S Service Manual


HCEN 9138 Rev. 10.2005

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Calibrations

BPM-test BPM sub-tests


The functionality of the blood pressure module, In the BPM service menu the following four
BPM, is described in chapter 2, Technical de- subtests are included:
scription.
BPM DIAGNOSTIC MENU
The maintenance to be carried out for the mod-
Inf Def AirLeak PrTest
ule is to check the accuracy for the pressure
transducers, to check the air leakage, to check
- Air leakage test: measures that the equip-
the inflation speed and to check the deflation
ment is airtight.
speed.
- Inflation speed test: measures the time to fill
the cuff with air.
By entering the service menu it is possible to
- Deflation speed: measures the speed of air
perform a check of the BPM device to determine
release from the cuff
if it works correctly.
- Pressure test: Check of pressure transducer
calibration
It is recommended to perform the test at least
every 12 months or after a repair/exchange of
Each of the tests can be carried out separately
the BPM.
but the above order for carrying out the sub-
tests is recommended.
Use following equipment:
- BPM Cuff no.3: 100 900 089
Check that the results from the sub-tests not
- BPM Tubing no. 1 (3,5 m): 100 900 094
exceed following limits:
- BPM test equipment: K2 2151 001 (100 mm
- Air leakage: maximum 18 mmHg/ 3 min
diameter rigid cylinder)
- Inflation speed: 2 -7 s
- Pressure transducer calibration tube kit:
- Deflation speed: 4 - 6 mmHg/s
K13 983 002.
- Static pressure: Maximum deviation from
- Pressure reference instrument: Measurement
reference to be within ± 3 mm Hg.
accuracy of ± 0.8 mm Hg
50 ± 3 mmHg
150 ± 3 mmHg
Test method: 250 ± 3 mmHg
1. Attach cuff no. 3 tight to the BPM test equip
ment, according to the illustrations below:
2. Start the AK 95 S with the main switch and
the ON/OFF button.
3. Enter Service mode.
4. Enter Diagnostics mode.
5. Select BM, BPM
23~33cm
CUFF No. (12cm)
12cm

AK 95 / AK 95 S Service Manual 6:21


HCEN 9138 Rev. 10.2005

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Calibrations

Check of air leakage Check of pressure transducer


By entering this test mode the air leakage for the calibration and measured pressure
BPM module, cuff hose and cuff will be tested
automatically. Before entering the test mode cuff By entering this test mode it will be possible to
no. 3 and cuff hose no. 1 to be connected to the check the actual pressure value for the BPM
AK 95 S. Cuff no. 3 to be wrapped tight to the pressure on the AK 95 S display.
BPM test equipment K2 2151 001.
Before entering the test mode, pressure trans-
Equipment K2 2151 001 to be used to simulate ducer calibration tube kit K1 3983 002 to be
the patient arm circumference. The air leakage is connected to the BPM connector on the rear of
tested for 3 minutes. If the displayed value is the AK 95 S. No cuff and cuff hose to be con-
above 18 mm Hg / 3 minutes, this indicates that nected.
there is a possible air leakage in the system.
Note! The pressure transducer calibration tube
It is of course also possible to perform this test kit must be drained before being connected, to
without the cuff and cuff hose connected but then make sure that no fluids or particles enters the
the test will only check for air leakage within the BPM connector or tubing’s.
AK 95 S. In this case replace the cuff and cuff
hose by a tube, which is closed. When “Measured pressure” is displayed it is
possible to start applying the external reference
Check of inflation speed pressure.
By entering this test mode the capacity for the
pump within the module will be tested automati- To check the actual pressure value, external
cally. pressure reference instrument to be connected
Before entering the test mode cuff no. 3 and cuff and external pressure of 250, 150, 50 mm Hg to
hose no. 1 to be connected to the AK 95 S. be applied. Check deviation from reference
pressure instrument for displayed value.
Cuff no. 3 to be wrapped tight to the BPM test
equipment K2 2151 001. If the displayed time is Trouble shooting:
above 7 seconds, this test indicates that the pump If the value from the air leakage test is above 18
is worn-out. mmHg/ 3 minutes, it indicates an air leakage in
the BPM system. First check for any air leakage
Check of deflation speed on the cuff, cuff hose or the connectors. If the air
By entering this test mode the functionality of leakage does not come from the cuff, cuff hose or
the valves within the module will be tested the connectors it indicates that the valves inside
automatically. Before entering the test mode cuff the BPM module are leaking. The BPM module
no. 3 and cuff hose no. 1 to be connected to the must then be replaced and sent to Gambro for
AK 95 S. Cuff no. 3 to be wrapped tight to the repair.
BPM test equipment K2 2151 001.
If the result from the inflation speed test ex-
If the displayed value is below 4 mm Hg/second ceeds the limit, first check for any air leakage in
this test indicates that there is a change in the the BPM system. A high value indicates that the
restriction for the valves affecting the time for pump capacity in the BPM is too low and there-
the air within cuff and cuff hose to be let out. fore the BPM module must be replaced and sent
to Gambro for repair.
If the result from the inflation speed test is
below the limit, check that the cuff hose is not
kinked or squeezed and that cuff no. 3 is con-
nected.

6:22 AK 95 / AK 95 S Service Manual


HCEN 9138 Rev. 10.2005

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Calibrations

If the result from the deflation speed test is


below the limit, check that the cuff hose is
correctly connected to the cuff and that the tube
is not kinked or squeezed.
Otherwise the failure is caused by the BPM
module and it must be replaced and sent to
Gambro for repair.

If the result from the pressure transducer cali-


bration test is outside the limits, it indicates that
the self-calibration function within the BPM
module not is able to adjust the pressure trans-
ducer output within limits. Possible causes are
pressure transducer or electronic circuits mal-
function. The BPM module must then be re-
placed and sent to Gambro for repair.

AK 95 / AK 95 S Service Manual 6:23


HCEN 9138 Rev. 10.2005

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Calibrations

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6:24 AK 95 / AK 95 S Service Manual


HCEN 9138 Rev. 10.2005

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Spare Parts List
AK 95 & AK 95 S
October 2005

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7- Spare Part List

Item Denomination Order no. Remarks


Spare Part List 10.2005

Contents :
Front panel outside ................................ 7-1
Front panel inside .................................. 7-2
Operators panel ..................................... 7-3
Blood pump ............................................ 7-4
Blood pump, Motor unit ......................... 7-5

Heparin pump ........................................ 7-6


Bottom box ............................................. 7-7
Magnetic Clamp unit ............................. 7-8
Blood leak det. Suction pump unit ........ 7-9
UF measuring unit ............................... 7-10

Bottom plate, Cond. cell ....................... 7-11


Bottom plate, Degassing pump .......... 7-12
Heater, Flow guard .............................. 7-13
Center plate, Valves ............................. 7-14
Center plate, Tubes.... ......................... 7-15

Variable flow unit.... ............................. 7-16


Boards ................................................... 7-17
Rear box ................................................ 7-18
Protective Covers ................................. 7-19
AC / DC ................................................. 7-20

MM95 with Stand ................................. 7-21


BPM, Battery backup - (Option), pH.....7-22
Inflow unit.......................................... 7-23
Front, MM95 ........................................ 7-24
MM I/O board ....................................... 7-25

Feeding pumps ..................................... 7-26


Mixing chamber, Flushing valve ......... 7-27
Conductivity cells ................................. 7-28
BiCart holder ........................................ 7-29
UFD (Option) ........................................ 7-30

Remote panel (Option) ......................... 7-31


Boards and Cablings ............................. 7-32

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HCEN9094 Rev.10 .2005

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7-1 Front panel outside

1
12
19

5
5
21 5,24
20
2
22 6 3
23 17
7

16
14 4 15 26
30

27
28
29 9
10 13
11
18
8 25

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7- 1 Spare Part List

Item Denomination Order no. Remarks

1 Front panel K21747001 AK 95: K21747002


2 O-ring 100318054
3 Pin 100320065
4 Cabling, reciving K21166001
5 O-ring 100318064

6 PT-screw 100366314
7 Level detector door K15114002
8 Shaft K17529001
9 Spring 100346026
10 Roller K12994001

11 Lundia 11 arm K15541B


12 Multi holder K20397003
13 Lundia Multi holder N01870003
14 Nut 100390400
15 Adjusting screw K04555001

16 Cabling, transmitting K16734001 to P609 BM I/0 board


17 Level detector complete K40106001
18 Insert 100316027
19 Screw 100372616
20 O-ring 100318055

21 Dripchamber holder K14034004


22 Locking pin 100320058
23 Washer 100392905
24 Tube holder K18527001
25 Knob 100300058

26 Locking washer 100322003


27 O-ring 100318091
28 Knob K19458001
29 Spring K14644001
30 Tube holder K18196001

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7-2 Front panel inside

3 12 14
13 11 8
5

10
venous pressure sensor

7
8 9

3
4
5 10
arterial pressure sensor
2
22
8 1
8
8
8
20
16
22 18 17
24 6 15
23 21

19 16
17

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7- 2 Spare Part List

Item Denomination Order no. Remarks


1 Protective cover K19412001
2 BM I/0 board K40111002
3 O-ring 100318064
4 Luer nut K11830003 red
5 Luer cone K18760001

6 Screw 100368410
7 Luer house K16001003 red
8 Screw 100378406
9 Arterial pressure line K15168001 to P612 BM I/O board
10 Pressure transducer board K16980001

11 Luer nut K11830002 blue


12 Luer house K16001002 blue
13 Cable clamp 100314173
14 Venous pressure line K19459A to BM I/O board P610 & P611
15 Level regulation complete K14155001

16 Washer 100392902
17 Nut 100390400
18 Screw 100370450
19 Pin 100320020
20 Screw 100378408

21 Screw 100374416
22 Spacer 100316092
23 Spacer 100316223
24 Washer K19586001

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7-3 Operator's panel

8
7
5

1
9
4 2
3 5
6 6
8 5

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7- 3 Spare Part List

Item Denomination Order no. Remarks

1 Jointing ring K12717001


2 Operator's panel K40138001
3 Knob, blood flow K14678C glue
4 Knob, set K18670001 glue
5 Screw 100378406

6 Washer, fiber 100322049


7 Holder, protective cover K18086001
8 Spacer 100316074
9 Overlay K23802001 English (AK 95 S)
9 Overlay K23803001 Italian (AK 95 S)

9 Overlay K23804001 Spanish (AK 95 S)


9 Overlay K23805001 German (AK 95 S)
9 Overlay K23806001 French (AK 95 S)
9 Overlay K23807001 Swedish (AK 95 S)
9 Overlay K23808001 Portuguese (AK 95 S)

9 Overlay K23809001 Russian (AK 95 S)


9 Overlay K23810001 Czech (AK 95 S)
9 Overlay K23811001 Finnish (AK 95 S)
9 Overlay K23812001 Danish (AK 95 S)
9 Overlay K23813001 Slovak (AK 95 S)

9 Overlay K23814001 NL / BE (AK 95 S)


9 Overlay K23815001 Turkish (AK 95 S)
9 Overlay K23816001 Polish (AK 95 S)
9 Overlay K23817001 Japanese (AK 95 S)
9 Overlay K23822001 English (AK 95)

9 Overlay K23823001 Italian (AK 95)


9 Overlay K23824001 Spanish (AK 95)
9 Overlay K23825001 German (AK 95)
9 Overlay K23826001 French (AK 95)
9 Overlay K23827001 Swedish (AK 95)

9 Overlay K23828001 Portuguese (AK 95)


9 Overlay K23829001 Russian (AK 95)
9 Overlay K23830001 Czech (AK 95)
9 Overlay K23831001 Finnish (AK 95)
9 Overlay K23832001 Danish (AK 95)

9 Overlay K23833001 Slovak (AK 95)


9 Overlay K23834001 NL / BE (AK 95)
9 Overlay K23835001 Turkish (AK 95)
9 Overlay K23836001 Polish (AK 95)
9 Overlay K23837001 Japanese (AK 95)

* Panel control board K40129001

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HCEN9094 Rev.10 .2005

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7-4 Blood pump

10
2 8
3

9
4,7
1,6

12

11

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7- 4 Spare Part List

Item Denomination Order no. Remarks

1 Bearing unit, CCW rotation K15610001 incl. item 4,6,7


2 O-ring 100318112
3 Race with cover K19694A A=arterial B=venous
incl. item 5
4 PT-screw 100368226

5 Cover K19693A A=arterial B=venous


incl. magnet
6 Magnet plate K15662001
7 Rotor guard bord K15670003
8 Screw 100379516

9 Cabling K13054001
10 Cover sensor PCB K20112001
11 Screw 100378416
12 Roller K20891001

* Pump rotor complete K40164001

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7-5 Blood pump Motor unit

8
7
6

9
2
4

5
10
1 3
11

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7- 5 Spare Part List

Item Denomination Order no. Remarks

1 Motor bracket K16432001


2 Motor compl. K40168001 incl. transmission
3 Cablage motor BPA K23945001 to P614 BM I/O board
4 Flexible mounting 100332013
5 Nut M6 M4 100390400

6 Edging strip 100312070


7 Protecting cover K11859001
8 Screw MCS 3x4 100370304
9 Clutch half assembly K04898003
10 Encoder cable K14140002 to P604 BM I/O board

11 Screw 100378410 to front

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HCEN9094 Rev.10 .2005

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7-6 Heparin pump

8
4

5 1

6
2

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HCEN9094 Rev. 10.2005

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7- 6 Spare Part List

Item Denomination Order no. Remarks

1 Motor complete K11792001


2 Belt 100329093
3 Encoder unit complete K16179001
4 O-ring 100318112
5 Locking washer 100322011

6 Screw 100378406
7 Housing K15765002
8 Piston Holder K15782002

* Heparin pump complete K15761002 incl. 1, 2, 3, 7, 8

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7-7 Bottom box

34
2 27,28
46

3 22
4 21
6
7
24
33
5 19
20
35
9
36
37
44
38
47
15
16
11 39
12
23

10

8 18
14
17
13

1
25 40
29
26,41,45

42
32
43 30,31

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7- 7 Spare Part List

Item Denomination Order no. Remarks

1 Bottom box K19900B AK 95: K19900A


2 Protective cap 100334283
3 Pressure switch ( SAGS ) K40115004
4 O-ring 100319044
5 Safety bypass house K12789001

6 PT-Screw 100368410
7 Washer K12957001
8 Nipple K14028002
9 Nut 100391002
10 Plug 100334219

11 Screw 100378410
12 Washer K17269001
13 Filter housing K13735001
14 Particle filter L50824001
15 O-ring 100319046

16 Filter house K13736001


17 Nut K12990004
18 Nipple K13739001
19 Nut K13737001
20 Connector angled K11982001

21 Tube no. 46 K18083001


22 Tube no. 45 K19899001
23 Locking washer 100322011
24 Connector, straight K10986001
25 Locking pin K15722A incl. locking ring

26 Screw 100370408
27 Dialyzer connector set, red K14081002
28 Dialyzer connector set, blue K14082002
29 Nut K18487001 locking fluid
30 Sensor pin K18381001 Dialysis tube guard

31 Locking ring 100330015


32 Sealing K18384001
33 Tube K12857001
34 Cabling K13048002 P516
35 Tube C K16457001 to REVA

36 T - connector K12961001
37 Cabling, external com. AK 95 K18610001
38 Screw 100203108
39 Locking ring K22591001
40 Nut 100390200

41 Nut 100316046
42 Earth cable K18592001
43 Screw 100370210
44 Pot. equalization connector 100202724
45 Washer 100322011

46 O-ring 100319009
47 Protective cap 100203201

* Diaconnector guard K40143001 incl. item 26,30-32,40-43,45


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7-8 Magnetic Clamp unit

19

1
3 2

7
8,12,16

9
10,11

4
6 5
15

14
13
17,18

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HCEN9094 Rev. 10.2005

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7- 8 Spare Part List

Item Denomination Order no. Remarks

1 Screw 100378420
2 Clamp driver board K11332001
3 Double magnet K11866A
4 O-ring 100318010
5 Compression shoe K04403003

6 Screw 100370416
7 PT-screw 100367308
8 PT-screw 100366258
9 Light guide 1 K14834001
10 Light guide 2 K14835001

11 O-ring 100318111
12 Priming detector board K11335003
13 Shaft K18042001
14 Roller K04402003
15 O-ring 100318067

16 FK2 cabling K11412001


17 Blue dot K05009002
18 Red dot K05009001
19 Clamp cover K19844001

* Clamp unit complete K18049001


* Clamp unit front parts K18049002
* Protective cover K20433001
* Priming detector kit K40147001 incl.item 8,9,10,11,12,15

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HCEN9094 Rev.10 .2005

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7-9 Blood leak det., Suction pump unit

17
13 6,7
18
15 14 8

24

10
16

11 13
20
22
21

23
9 16 16 25
14
12
28
19 29
5
26
27 4

31 1
30

2
3

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HCEN9094 Rev. 10.2005

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7- 9 Spare Part List

Item Denomination Order no. Remarks

1 Pump unit K18998001


2 Screw 100370450
3 Gasket K13572001 glue
4 Screw 100370430
5 Nipple K14158001

6 Cover K16215002
7 O-ring K16214001
8 Blood leak detector K15943001
9 Tube no. 29A K16039001
10 Flow reducer K05314001

11 Washer 100392902
12 Connector straight K10986001
13 Tube no. 53 K18658001
14 Connector angled K12951001
15 Tube no. 52 K18916001

16 Tube 100312056 30 mm
17 Tube no. 27 K12879001
18 Connector T K12961001
19 Cabling K12914001
20 Screw 100370410

21 Nipple K01515002
22 Tube, silicone 100312032 to EVVA
23 Flow reducer K05041001
24 Connector straight K10986002
25 Tube 100312056 67 mm

26 O-ring 100319056
27 Flat pin connector 100214082
28 Screw 100370408
29 Locking washer 100322011
30 Motor K40126001

31 Pump head K19157001 incl. driving magnet

* Pump repair kit K19143001

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HCEN9094 Rev.10 .2005

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7-10 UF measuring unit

8
10
14
17
7
11
9

16 2
4 15
13 1
21
3

12
18

6
9

19
20

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HCEN9094 Rev. 10.2005

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7-10 Spare Part List

Item Denomination Order no. Remarks

1 UF measuring unit compl. K40139001


2 FM I/0 board K40152001
3 Temp unit K12781A
4 Fluid protection K20249001
5 Connector angeled K11982001

6 Tube no. 23 K15268001


7 Tube no. 12B K12889001 to cond. cell, upper
8 Tube no. 31 K12883001
9 T- Connector K12961001
10 Screw 100370306

11 Tube no. 32 K15270001


12 Tube no. 14 K12868001
13 Spacer 100316124
14 Spacer 100316212
15 PT-screw 100368410

16 Cabling K13031001
17 Cabling K18189001 to Relay board P930
18 Carbon connector K21644001
19 Washer 100322010
20 Screw 100370314

21 Clip K08502001

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HCEN9094 Rev.10 .2005

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7-11 Bottom plate, Conductivity cell

5
6

7
8 11 3
4 20
3 10
16 22
2 12
1 23
19 24
21
18
17
14
13

27 25
46
9 26

14
15 1
1 28 28 37 43
30 31
44
28 09
239
14
29
14
14
25 45 38
32 25 42
33 41
34 40
39
35
25
36

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HCEN9094 Rev. 10.2005

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7-11 Spare Part List

Item Denomination Order no. Remarks


1 PT-screw 100369360
2 Fluid protection K13271001
3 Screw 100373408
4 Clips 100314181
5 Fan complete K12753A

6 Tube 100312093 to press.regulator


7 Clamp 100334203
8 Connector straight 100334040 exl. item 9
9 Washer 100335002
10 Housing K12789001 INPS

11 Nipple K16260002
12 O-ring 100319044
13 Cabling K13030001
14 Screw 100370406
15 Conductivity cell compl. K40102002

16 Screw 100372609
17 Tube no. 12B K12889001
18 Pressure switch K12763002 INPS
19 Washer K12957001
20 Spacing screw 100316135

21 Screw 100368420
22 Relay board K40156001
23 Washer 100322047
24 Screw 100316039
25 Washer 100322011

26 Screw 100378406
27 Cable INPS K13046002
28 Connector angled K12951001
29 Earth cable K18591001 to AC/DC
30 Tube 100312056 198 mm

31 Tube no. 44 K17798001 to MM 95


32 PT-Screw 100370408
33 Screw 100370410
34 Washer K06180001
35 Earth wire K24059001 to MM 95

36 Bottom plate K17796A


37 Housing K14041001 HPG
38 Earth cable K12914001 to suction pump
39 O-ring 100319007
40 Adapter K22547001

41 O-ring 100319029
42 Pressure transducer K21400001 HPG
43 Washer K19013001
44 Tube no. 23909 K23909001
45 Tube no. 14 K12868001

46 Earth cable K18593001

* Pressure Transducer Kit K19282001

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HCEN9094 Rev.10 .2005

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7-12 Bottom plate, Degassing pump
21 48 39
20 32 40
38 26 25
19

7
5
24 29,44,42,18
31
10 9 4
8
15 33
7
34
15
1 16
7
14 27
36
2 28
23
34
35
7
50 41
47
7 49
6
30
37 46
13 11 45
39
26 43
51
32
48
25
40
3 39
12 16
17 22

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HCEN9094 Rev. 10.2005

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7- 12 Spare Part List

Item Denomination Order no. Remarks

1 Degassing chamber, compl. K12950002


2 Float complete K15848A
3 Screw 100370405
4 Tube 100312056 198 mm
5 Tube no. 28 K12886001

6 O-ring 100319050
7 Screw 100370408
8 Connector, angled K12951001
9 O-ring 100319008
10 Distans screw 100316102

11 Tube, silicone 100312032 80mm


12 Deairating chamber, complete K12830003 004=without press.transducer
13 O-ring 100319054
14 Cabling K16724001 to P503 FM I/O board
15 Tube no. 11 K15805001

16 Connector straight K10986001


17 Tube no. 46 K18083001
18 Screw 100370304
19 Tube no. 50 K19567001
20 T-connector K12961001

21 Tube no. 29 K16009001


22 Tube no. 20 K12874001
23 Nut 100390500
24 Housing K14041001
25 Pressure transducer K21400001

26 O-ring 100319007
27 Nipple K14158001
28 O-ring 100319056
29 Battery holder K18644001 incl. cabling
30 Washer K06180001

31 Valve housing K16952A


32 Adapter K22547001
33 Cabling clamp 100314173
34 Cabling clamp 100314178
35 Screw 100370430

36 Flat pin connector 100214082


37 Gasket K13572001
38 Tube no. 29 A K16039001
39 PT-screw 100369360
40 Washer K19013001

41 Pump unit K18998001


42 Battery holder plate K18642001
43 Nipple K01515002
44 Screw 100374306
45 Locking washer 100322011

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HCEN9094 Rev.10 .2005

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7-12 Bottom plate, Degassing pump
21 48 39
20 32 40
38 26 25
19

7
5
24 29,44,42,18
31
10 9 4
8
15 33
7
34
15
1 16
7
14 27
36
2 28
23
34
35
7
50 41
47
7 49
6
30
37 46
13 11 45
39
26 43
51
32
48
25
40
3 39
12 16
17 22

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HCEN9094 Rev. 10.2005

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7-12 Spare Part List

Item Denomination Order no. Remarks

46 Earth cable K18592001 to dialysis tube guard


47 Level guard K40136001
48 O-ring 100319029
49 Motor K40126001
50 Pump head K19157001 incl. driving magnet,pump head

51 Mounting plate for


degassing chamber K20463001

* Degassing chamber complete K12950002


* Pump repair kit K19143001
* Battery 100224006 rechargeable

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HCEN9094 Rev.10 .2005

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7-13 Heater, Flow guard

12
1
2 11
10
4
8
13

3 6

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HCEN9094 Rev. 10.2005

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7- 13 Spare Part List

Item Denomination Order no. Remarks

1 Screw 100370410
2 Heater compl. K40114001 100V, 1000W
Heater compl. K40114002 115V, 1300W
Heater compl. K40114004 230V, 3 x 580W
3 O-ring 100319055

4 Tube no. 78 K19364001


5 Connector T K12961001
6 Temp. transducer compl. K12781A
7 Tube no. 42 K16698001 to MM95 tube no. 41
8 Holder 100314177

9 Screw 100389612
10 O-ring 100319042
11 Strap 100314068
12 Flow switch compl. K19835001
13 Cabling FK2 Priming K11412001

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HCEN9094 Rev.10 .2005

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7-14 Center plate, Valves

13
11 2
12
4 3
10 1

15
10 6
INVA
7
RIVA
6 AIVA

9 BYVA 12
4

1 14
10
4 DIVA
7
ZEVA

C
15
1 3
12 8
11 2 1 TAVA
A
A REV
14 EVV
2 10 6
1

15

16

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HCEN9094 Rev. 10.2005

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7- 14 Spare Part List

Item Denomination Order no. Remarks

1 Screw 100378325
2 Screw 100378330
3 Valve membrane K08056C
4 Nut 100316082
5 Valve housing complete K16617A

6 Solenoid valve K15035001


7 Tube no.15 K15581001
8 Tube C K16457001
9 Valve housing complete K15235A
10 Screw 100378304

11 Tube 100312056 30 mm
12 T-connector K12961001
13 Connector straight K10986001
14 Connector angled K12951001
15 Screw 100370405 locking fluid

16 Cabling K16712001 from Control Driver board


P400 to all magnets+UFD

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HCEN9094 Rev.10 .2005

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7-15 Center plate, Tubes

23

13
14 22 21 20

21* 6
20 INVA
32
7 16 5
10
RIVA
28
14
33 29 BYVA 16

11 18
4

9
19 DIVA 30

27 14 ZEVA 20

TAVA
22

13 8
A
12 EVV
3
15 1 7
17
3
4
26
7 47
24
32

23

31
50
34
25

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HCEN9094 Rev. 10.2005

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7- 15 Spare Part List

Item Denomination Order no. Remarks

1 Tube 100312032
2 Pressure regulator complete 100313252
3 Nippel K01515002
4 Tube 100312056 30 mm
5 Connector straight K10986001

6 Connector angel K12951001


7 Center plate K16348A
8 Reducer K24016001
9 T-connector K12961001
10 Valve housing complete K15235A 9 pcs.

11 Tube K15372001
12 Chamber complete K16884004
13 Strap 100314016
14 Tube no. 40 100312056 40 mm
15 Tube, silicone 100312032 to deairating chamber

16 Tube no. 4 K16424001


17 Tube no. 7 K12862001
18 Tube no. 16 K12870001
19 Tube no. 22 K12876001
20 Tube silicon 100312093

21 Clamp 100334203
22 Strap 100314058
23 Tube no. 78 K19364001
24 Screw 100370405 locking fluid
25 Tube no. 50 K19567001

26 Tube no. 47 K16699001


27 Tube K19899001 to filternipple front
28 Tube no. 14 K12868001
29 Tube no. 15 K12869001
30 Tube no. 20 K12874001

31 Tube no. 23 K15268001


32 Tube no. 28 K12886001
33 Tube no. 29 K16009001
34 Tube no. 32 K15270001

* Pos.20 strapt to pos. 23 (tube no.78)

/
HCEN9094 Rev.10 .2005

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7-16 Variable flow unit

2
to Step
driver board

8 1 7
4
3

5
12

13,14,15
4 9,10
11
6

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HCEN9094 Rev. 10.2005

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7-16 Spare Part List

Item Denomination Order no. Remarks

1 Motor holder K15162001


2 Cable K23957001 to step driver board
3 Flow restrictor K24016001
4 Screw 100378330
5 Tube 100312056 30 mm

6 Locking nut 100316082


7 Locking nut 100316046
8 Screw 100378430
9 Screw 100380304
10 Pin 100320079

11 Motor K13403B
12 Valvehouse Spec. complete K24055001
13 Spacer K15049001
14 Washer 100322003
15 Spring 100346054

* Variable flow unit K40175001 incl. item 1, 6-12

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HCEN9094 Rev.10 .2005

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7-17 Boards

Protective

7
1 9
2 4
3
8
e
Protectiv

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7-17 Spare Part List

Item Denomination Order no. Remarks

1 Protective Driver board K17552003 with frame


2 Protective CPU board K17553005 with frame
3 Control CPU board K17554006 with frame
4 Control Driver board K17555004 with frame
5 Quick-acting lock K04813001

6 PT-screw 100368410
7 Screw 100370440
8 Screw 100370425
9 Fiber washer 100322049

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HCEN9094 Rev.10 .2005

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7-18 Rear box

2 6

7
5

/
HCEN9094 Rev. 10.2005

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7-18 Spare Part List

Item Denomination Order no. Remarks

1 Infusion stand,straight K19073B


2 Screw 100388612
3 Knob 100300048
4 Cover, rear K18493B AK 95: K18493A
5 Air filter K12966001 Rear cover

6 Infusion stand,angled K19073A


7 Filter holder K16963001

* Insert holder, left K12731A Included in item 4


* Insert holder, right K12963A Included in item 4
* Pin K12732001 Included in item 4

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HCEN9094 Rev.10 .2005

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7-19 Protective Covers

8 5

*The figures do not correspond to their actual sizes.

/
HCEN9094 Rev. 10.2005

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7-19 Spare Part List

Item Denomination Order no. Remarks

1 Protective cover K17187001 operators panel, see 7: 3


2 Protective cover K19412001 BM I / O board
3 Protective cover K23874001 FM I/O board
4 Protective cover K23857001 Relay board
5 Top tray K19864001

6 Protective cover K19836001 AC/DC, see 7:19


7 Protective cover K19844001 Magnetic clamp unit, see 7-8
8 Protective cover K20433001 Priming det. board

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HCEN9094 Rev.10 .2005

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7-20 AC / DC

9
5

6
7
1 8

2 T12AH
250AC

HALT

BACH BACO

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HCEN9094 Rev. 10.2005

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7-20 Spare Part List

Item Denomination Order no. Remarks

1 AC / DC K40130001
2 Fuse 12AT 100213113
3 Filter K23734001
4 Clamp 100314011
5 Screw 100370408

6 Nut 100316046
7 Earth cable K18591001 to bottom plate, rear
8 Locking washer 100322011
9 Protective cover K19836001

* Mains cable K40159001 100-115 V


* Mains cable 100220212 230 V
* Mains cable 100220303 230 V, For China (with ferrit)
* Mains cable 100220304 230 V, For UK (with fuse and ferrit)
* Ferrit 100120100

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HCEN9094 Rev.10 .2005

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7- 21 MM95 with Stand
8 6
9

7 21
10
19
11
18
2

15
19
22
1
5 4

3
6
7
31 33
32

17
13
20

23

12

16

28
14 14

26

30
24,25

29 27

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HCEN9094 Rev. 10.2005

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7- 21 Spare Part List

Item Denomination Order no. Remarks

1 Screw 100370410
2 Front K19840D AK 95: K19840C
3 Stand K16272B
4 Cover, left K16494D AK 95: K16494C
5 Cover, right K16495004 AK 95: K16495003

6 Screw 100378406 Locking fluid


7 Screw 100370440
8 Frame, upper complete K16703D AK 95: K16703C
9 Screw 100388812
10 Plug 100316206

11 Earth wire K24059001


12 Wheel 100304124 Stainless
13 Frame, lower complete K19838001
14 Wheel with brake 100304125 Stainless
15 Leadthrough K17196001

16 Screw 100388825
17 Shelf K19839001
18 Locking washer 100322011
19 Washer K06180001
20 Tube no. 48 K16759001 to tube no. 47 DRVA

21 Screw 100388510
22 Washer K17269001
23 Tube no. 41 K16758001 to tube no. 42
24 Screw 100388612
25 Cap 100300046

26 Service tray K19557001 option


27 Front holder complete K19552001
28 Pick-up tube holder K16513004
29 Screw 100374510
30 Locking nut 100316096

31 Cabling K18136001
32 Tube no. 44 K17798001 to heat exchanger
33 Tube no. 43 K17764001

* Adaption kit K23919002 WRO 300, holder included


* Holder for WSF K23919003 WSF - Water Softener
* Holder K40161001 WRO 300

/
HCEN9094 Rev.10 .2005

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7- 22 BPM, Battery backup - (Option), pH

7,8

2
9 14,41
1 15
13
5

12

29-40 26
11
27,28
3
10
4
6

16,17
18
19
20
21
22,23
24,25

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HCEN9094 Rev. 10.2005

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7- 22 Spare Part List

Item Denomination Order no. Remarks

1 Blood pressure monitor board K40127001


2 BPM plate K23504A
3 Cabling K23531001 BPM to PCB-BPM
4 Protective cover K23555001
5 Protective cover K23556001

6 Blood pressure module K40128002


7 Flat cable ferrite 100120102
8 Mounting clips 100120103
9 Spacer screw 100316315
10 Screw 100370304

11 Screw 100370306
12 Screw 100370405
13 Screw 100374406
14 BPM connector 100334255
15 Silicone tube 100312032

16 Cable K20396001
17 Strap 100314016
18 Battery kit K40151001 Incl. 2 batteries
19 Cable K22728001
20 Cable K22730001

21 Battery box K20382001


22 Fuse 100213092 15 AT
23 Fuse insert 100212007
24 Screw 100388612
25 Washer 100392903

26 Clip 100314197
27 Screw 100378408
28 Clip 100314156
29 pH-sensor K12299001
30 O-ring K14686001

31 Washer K09974001
32 Tube 100312056 L = 105 mm
33 Tube 8b K15730001
34 Tube connection K10986001
35 Connector, angled K12951001

36 Dummy K13884001
37 Cable clip 100314156
38 Screw 100370408
39 PT screw 100366310
40 Washer 100392902

41 Cover plug 100316316

* BPM complete K23564001


* Cuff holder M6957575
* Battery backup unit complete K23246001

/
HCEN9094 Rev.10 .2005

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7-23 Inflow unit
9
25
1 26
6

8 10 14
11 15
16

19
7
17
18
16

4 7
17
20
16

12

7
17

16
25 7
17 9 10 21 27
3 22
5

23
21
Left view 24
11
1

13

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HCEN9094 Rev. 10.2005

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7-23 Spare Part List

Item Denomination Order no. Remarks

1 Pressure regulator 100313254


2 Heat exchanger K15876005 110V
3 Heat exchanger K15876006 110V/220V
4 Heat exchanger K15876007 110V
5 Heat exchanger K15876008 110V

6 Holder K20194001
7 Holder K16276001
8 Clamp 100334203
9 Tube armoured 100312093 260 mm
10 Tube armoured 100312093 85 mm

11 Tube armoured 100312093 210 mm


12 Tube armoured 100312093 35 mm
13 Tube armoured 100312093 110 mm
14 Connector, angled 100334042
15 Nipple K16260002

16 Screw 100370612
17 Screw 100370406
18 Connector straight K10986001
19 Connector angled K12951001
20 Tube 100312056 68 mm

21 Nut K18032001
22 Nipple K19219001
23 Nipple K16273002
24 Tube K13231004
25 Tube no. 44 K17798001 to INPS

26 Tube no. 43 K17764001


27 Tube 100312012 80 mm

/
HCEN9094 Rev.10 .2005

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7-24 Front, MM95

7
18
15
14

20
19
8 10
4 8 11 9
6
2 21

5
16
13 14
17
12
15
1
17
13
3

12

15

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7- 24 Spare Part List

Item Denomination Order no. Remarks

1 Front K19840D AK 95: K19840C


2 Concentrate nipple K17990007
3 Concentrate nipple K17990008
4 Concentrate intake K17991007
5 Concentrate intake K17991008

6 O-ring 100319061
7 Cabling PTBH AK 95 K18205001 to MM I/O board P703
8 PT sensor board K18254001
9 Connector K17725001
10 Nipple K01515002

11 Screw 100368408
12 Concentrate filter K16538A
13 Nipple K15232001
14 Nut, plastic 100316061
15 Tube, silicone 100312032 500 mm

16 Tube, silicone 100312032 100 mm


17 Tube, silicone 100312032 40 mm
18 Pick-up tube white 100850007
18 Pick-up tube blue 100850008
18 Pick-up tube yellow 100850021

19 Tube, silicone 100312032 320 mm


20 Tube, silicone 100312032 190 mm
21 Cap L50669004

* Concentrate connector kit K18440002

/
HCEN9094 Rev.10 .2005

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7-25 MM I / O board

10

6
9 7

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HCEN9094 Rev. 10.2005

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7- 25 Spare Part List

Item Denomination Order no. Remarks

1 Edgin strip 100312029


2 MM I/O board K40090002
3 Spacer 100316222
4 Spacer 100316223
5 Screw 100370310

6 Protective cover K16763001


7 Screw 100370406
8 Locking washer 100322010
9 Locking nut 100316082
10 Mounting plate K16274001

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HCEN9094 Rev.10 .2005

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7-26 Feeding pumps

15

18
14
16

10

18
7
10 19
2

6
3
4

5
20 7
13 12
9
11

14

17
8

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HCEN9094 Rev. 10.2005

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7-26 Spare Part List

Item Denomination Order no. Remarks

1 Tube, silicone 100312032 190 mm


2 Motor unit K14621001 incl. handle wheel
3 Nut 100390400
4 Flexible mounting K02691001
5 Screw 100388612

6 Screw 100378408
7 Tube, soft 100312012
8 Tube, silicone 100312032 100 mm
9 Nipple K01515002
10 Tube, silicone 100312032 300 mm

11 Tube, silicone 100312032 320 mm


12 Tube, silicone 100312032 300 mm
13 T- Connector K12961001
14 Connector, angled K12951001
15 Tube no.41 K16758001

16 Tube no. 4 K14735001


17 Tube no. 61 K20547001
18 Cabling K16725001 to MM I / O board P707
19 Screw 100370335
20 Tube 100312056 60 mm

* Feeding pump compl. K21264001 incl. item 2-5


* Pump head replacement kit K21095003

/
HCEN9094 Rev.10 .2005

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7-27 Mixing chamber, Flushing valve

15
11 14
4 10

5 13
5 6
8 25
15
1
16
5
6
22
9 18 26
2 27
3 3
15
24
17

23

6
19
16
12
20

9
12
5

21

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HCEN9094 Rev. 10.2005

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7- 27 Spare Part List

Item Denomination Order no. Remarks

1 O- ring 100319050
2 Mounting bracket K13992001
3 Screw 100370406
4 Screw 100370410
5 Nipple K01515002

6 T- Connector K12961001
7 Connector, angled K12951001
8 Tubes, silicone 100312032 100 mm
9 Tube 100312056 245 mm
10 Tube no. 4 K14735001

11 Valve connector K15937001


12 Connector K10986002
13 Tube no. 10 K15731001
14 O- ring 100319008
15 Tube, santoprene 100312141

16 Tube, silicone 100312032 200 mm


17 Nut 100316082
18 Tube no. 11 K15292001
19 Tube K13231004
20 Filter K16538A

21 Tube, silicone 100312032 420 mm


22 Valve housing complete K21139003 incl. item 17, 25-27
23 Solenoid valve K15035002
24 Screw 100378304
25 Screw 100378325

26 Membrane K08056C
27 Washer K21486001

* 3-way valve unit complete K15285005 FLVA incl. item 22-24


* Mixing chamber complete K12950005

/
HCEN9094 Rev.10 .2005

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7-28 Conductivity cells

5
11
1 7
Conductivity
cell, left 14
8
4
6

13
10

9
12
2
4
11 3
7
Conductivity
cell, right 1
8
6

13
10

9
12

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HCEN9094 Rev. 10.2005

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7- 28 Spare Part List

Item Denomination Order no. Remarks

1 Conductivity cell complete K40102002


2 Tube no. 48 K16759001
3 Tube, santoprene 100312141 250 mm
4 Nipple K01515002
5 Tube no. 10 K15731001

6 Fluid protection K13271001


7 Tube K13231004
8 PT-screw 100369360
9 Tube 100312056 245 mm
10 Cabling K11291001

11 T- Connector K12961001
12 Connector, angled K12951001
13 Screw 100370408
14 Tube, santoprene 100312141 310 mm

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HCEN9094 Rev.10 .2005

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7-29 BiCart holder

1 19
12 16 1 13
5 17

18 15
4 19
16
8
6,9,10
17
11 12
3 13
12
7,9,10
2 5 12 16 2 13
17

14
4

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HCEN9094 Rev. 10.2005

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7- 29 Spare Part List

Item Denomination Order no. Remarks

1 Arm, upper K23031002


2 Arm, lower K21557005
3 Sealing K17502001
4 Shaft K17481001
5 Spring K17503001

6 Bypass nipple K14908001


7 BCH bypass valve K14425001
8 Cabling K14910001
9 O-ring 100319026 4 pcs.
10 Retaining ring 100330021

11 Tube, silicone 100312032 190 mm


12 Magnet K19049002
13 T-connector K17237001
14 Tube, silicone 100312032 420 mm
15 O-ring 100319032

16 O-ring 100319008
17 O-ring 100319046
18 Tube, silicone 100312032 140 mm
19 Protective ring K22829001

* BiCart holder complete K22390004


* Spikekit, upper K23031004
* Spikekit, lower K21557006

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HCEN9094 Rev.10 .2005

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7-30 UFD (Option)

18 1 6 11 16 8 10

13

14

4 5 7 17 12 9 6

2 6 19 15

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HCEN9094 Rev. 10.2005

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7- 30 Spare Part List

Item Denomination Order no. Remarks

1 Valve unit K15078001


2 Filterholder complete K17724005
3 Mounting plate K19484002
4 Connector K16273002
5 Nut K18032001

6 Connector angled K12951001


7 Connector straight K10986001
8 Connector, T K12961001
9 Tube 54 K19876001
10 Tube 55 K19877001

11 Tube 56 K19878001
12 Tube 57 K19879001
13 Tube 62 K20671001
14 Tube 63 K20672001
15 Tube 64 K20673001

16 Tube 65 K21507001
17 Cabling valves AK 95 S K16712001
18 Screw 100370406
19 Screw 100378530

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HCEN9094 Rev.10 .2005

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7-31 Remote panel (Option)
14
18 6 7 8 12,7
15
16,17

11

13
4 5 9 10
3
2
1

22
23
24
25

26 19,20,21

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HCEN9094 Rev. 10.2005

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7- 31 Spare Part List

Item Denomination Order no. Remarks

1 Front panel K40140001 incl. gasket


2 Gasket K12717001
3 Blind panel K21648002
4 Holder K21651001
5 Spacer 100316307

6 Cable strap 100314312


7 Washer 100322011
8 Screw 100374408
9 Protective cover K23184001
10 O-ring K23195001

11 Holder K23046001
12 Screw 100385408
13 Rear panel K23191A
14 Washer 100322049
15 Gasket K23045001

16 Arm K40134002 Incl. pos 7, 11-15 and pos 17


17 Screw 100385308
18 Clip 100314307
19 Spacer K20245001
20 Screw 100378416

21 Screw 100316093
22 Screw 100378406
23 Baffle plate K23192001
24 Screw 100378316
25 Cable holder K23190001

26 Cable attachment kit K40141001

* Remote panel K23054001

/
HCEN9094 Rev.10 .2005

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7-32 Boards and Cablings

EN1107

10. Step driver board

/
HCEN9094 Rev. 10.2005

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7- 32 Spare Part List

Item Denomination Order no. Remarks


1 Protective Driver Board K17552003 ( with frame )
P200 cabling K18133001 to control Driver board P408
P201 cabling K21166001 to air detector
P202 cabling K18169001 to FM I/O board P509
P203 to protection CPU board P100
P204 cabling K18170001 to BM I/O board P601
P205 cabling K18644001 to battery, includes battery holder
P209 not used
P210 cabling K13030001 to conductivity cell P
P211 cabling K23449001 to Panel Control board P1

2 Protective CPU Board K17553005 ( with frame )


P100 to protective Driver board P203
P101 not used
P102 not used
P104 cabling K18134001 to control CPU board P305
P105 cabling K17801001 to clamp
P106 cabling K18132001 to control CPU board P300
P107 cabling K18136001 to MM I/O board P705
P109 cabling K18136001 to BPM board P2
P200 not used

3 Control Driver Board K17555004 ( with frame )


P400 cabling K16712001 to solenoid valves
P401 cabling to fan
P402 cabling K13031001 to UF cell
P403 not used
P404 not used
P405 to control CPU board P306
P406 cabling K18190001 to FM I/O board P500
P407 cabling K18135001 to BM I/O board P600
P408 cabling K18133001 to protective Driver board P200

4 Control CPU Board K17554006 ( with frame )


P300 cabling K18132001 to protective CPU board P106
P301 cabling K18610001 to external communication connection
P302
P303 not used
P304 cabling K18136001 to MM I/O P705
P305 cabling K18134001 to protective CPU board P104
P306 to control Driver board P405
P308 to AC/DC
P309 to AC/DC
P310* for Step driver board
P311* for Step driver board
P312 cabling to AC/DC
P313 not used
* any of these can be used

5 Relay board K40156001


P930 cabling K18189001 to FM I/O board P501
P931 to AC/DC
P933 to heater
P934 cabling K23899001 to FM I/O board P519

/
HCEN9094 Rev.10 .2005

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7-32 Boards and Cablings

EN1107

10. Step driver board


/
HCEN9094 Rev. 10.2005

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7- 32 Spare Part List

Item Denomination Order no. Remarks


6 MM I / O Board K40090002
P700 to pH-electrode
P701 cabling K11291001 to conductivity cell A
P702 cabling K11291001 to conductivity cell B
P703 cabling K18205001 to BiCart holder and pick-up tubes
P704 cabling K16727001 to FLVA
P705 cabling K18136001 to control CPU board P304 and protection CPU board P107
P706 pH-sensor
P707 cabling K16725001 to feeding pumps

7 FM I / O Board K40152001
P500 cabling K18190001 to control Driver board P406
P501 cabling K18189001 to relay board P930
P502 cabling K13046002 to inlet pressure switch INPS
P503 cabling K16724001 to deairating chamber
P504 cabling K11412001 to priming detector
P505 to high pressure trancducer
P506 to degassing pressure
P507 to regulator temp
P508 to degassing pump
P509 cabling K18169001 to protective Driver board P202
P510 not used
P511 to dialysis pressure transducer
P512 to blood leak detector
P513 cabling K11412001 to flow switch
P514 cabling microswitch
P515 to suction pump
P516 cabling K13048002 SAGS
P517 not used
P519 cabling K23899001 to relay board P934

8 BM I / O Board K40111002
P600 cabling K18135001 to control Driver board P407
P601 cabling K18170001 to protective Driver board P204
P603 to heparin potentiometer
P604 cabling K14140002 to blood pump tacho
P605 cabling K13054001 to blood pump rotation indicator
P606 to heparin pump motor
P607 to heparin pump overload
P608 cabling to cover sensor
P609 cabling K16734001 to air detector
P610 to venous press.transducer, control system
P611 to venous pressure transducer, protection system
P612 to arterial pressure transducer
P613 cabling K13059001 to arterial guard
P614 cabling K23945001 to blood pump motor

9 Panel Control Board K40129001


P1 cabling K23449001 to protective Driver board P211
P2 to panel P1
P3 to panel P2
P4 to panel P3

10 Step Driver Board K23927001


P2 cabling K23957001 to Variable flow unit - motor

/
HCEN9094 Rev.10 .2005

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HCEN9094 © Gambro Lundia AB,1996. Revision October 2005

Gambro Lundia AB, Monitor Division


Box 10101
SE-220 10 Lund
Sweden

Tel: +46 46 16 90 00
Fax: +46 46 16 96 96
www.gambro.com

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Chapter9

SymbolDescription

HCEN9160 Revision 10. 2005


Service Manual - Symbols 9:1
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List of symbols

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

Description

Alternating current

Protective earth (ground)

Warning, consult accompanying documents

Off (power, disconnection from the mains)

On (power, connection to the mains)

Type B, applied part

Handle with care

This way up

Keep dry

Input /Output

Year of manufacturing

Heater power supply outlet

Conforms to requirements in EC Council Directive 93/42/EEC


concerning medical devices. 0086 identifies BSI, British Standards
Institution, as Notified Body.

CSA approved for Canada

HCEN9160 Revision 10.2005


Service Manual - Symbols 9:2
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CSA approved for Canada and USA

CSA-listed label manufacturer

Prohibited behaviour

Equipotentiality

Separate collection for electrical and electronic equipment

HCEN9160 Revision 10.2005


9:3 Service Manual - Symbols
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HCEN9160 Revision 10. 2005


9:4 Service Manual - Symbols
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Replacements

Replacements

Replacement matrix...................................... 2
Changeactions ..................................................... 4
FM Flow Diagram ............................................... 5

AK 95 / AK 95 S HCEN12078 Rev.10.2005 10:1

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Replacements

Replacement matrix
The actions to carry out after a component
replacement are brought together in a replace-
ment matrix.

The numbers in the matrix show which actions


and in which order they will be done. It is impor-
tant that the actions are done and in the correct
order.

In the matrix, BM stands for Blood Monitor and


FM stands for Fluid Monitor.

The replacementmatrix is only a guideline for


service technicians which actions to perform
when a component has been replaced.

10:2 AK 95 / AK 95 S HCEN12078 Rev.10.2005

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Checklist for component replacements on AK 95 / AK 95 S
Replaced FM components Replaced BM components Electronics

AK 95 / AK 95 S HCEN12078 Rev.10.2005

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Bloodleak
BPM
Conductivity Cell A
Conductivity Cell B
Conductivity C ell P
Degassing Pressure Transducer
Degassing pump
External pressure regulator
Feeding pump A
Feeding pump B
Flow restrictor
FM I/O board
Heater
Variable flow unit (or parts)
HPG Transducer
Internal pressure regulator
INPS
PD Transducer
pH cell
Relay board
SAGS
Suction pump
UF-cell B
Blood pump motor unit
Blood pump rotor
BM I/O board
Clamp unit complete
Heparin pump
Level detector (Air detector)
Operator's panel
Pressure Transducer (V & A)
Priming detector
Control CPU board
Protective CPU board
Control driver board
P r ot ect iv e driv e r board

Clean the machine from calcium


1 1 1
and then from proteins and fats
I2C scan 1 2 2 2 1 1 1 1
Total default 1 1
Load preset file 2 2
Calibrate Conductivity Cell A A 3A
Calibrate Conductivity Cell B A 3A
Calibrate Conductivity Cell P A 3A
Calibrate pH 1
Calibrate Pressure Transducer A 2A 2A 2A
Calibrate Bloodleak 2
Calibrate Internal pressure regulator 2 1
Fch 3 2 4 4 4 3 1 3 1 1 1 1 1 3 2 1 3 2 1 1 1 1 1 2 1 2 1 1 1 3 2 7 5 1 2
Heat Disinfection 4 6 6 6 4 2 2 2 3 2 2 4 3 4 3 2 2 2 3
Check conductivity value 5 5 5
Simulated treatment 2 2

Actions to be done
Calibrate External pressure regulator 1
Check BPM 1
Calibrate Priming detector 1 1 4
Calibrate Pressure transducer A 2A
Occlusion 1
Calibrate A/D conv. 3 3
Calibrate clock 4 1
Check fluid flow 2 2 6
Calibrate variable flow 1 5

Remarks:
A
Not necassary to calibrate if new spare part is installed (factory calibrated)
B
Important to follow the order of the calibrations/actions for machine performance
Replacements

10:3
Replacements

Change actions

A list of all actions and explanations how to Check conductivity value


execute them is found below. Check conductivity value according to hospital
laboratory.
Clean the machine from calcium and then from
proteins and fats Simulated Treatment
Perform actions according to Operators manual. Simulate a treatment according to check/calibra-
tion instructions in the Maintenance Manual.
I2C scan
Perform actions according to Service Manual, Calibrate pressure according to Technical Data
Service Technicians Guide, Diagnostic Flow Calibrate according to calibration instructions in
diagram. the Service Manual, Calibration Manual, Techni-
cal Data and Specifications Manual.
Total default
Perform actions according to instructions in Check BPM
Service Manual, Service Technicians Guide. Check according to BPM test instructions in the
Service Manual in the chapter Calibration
Load preset file Manual.
Perform actions according to clinic demands.
Calibrate Priming Detector
Calibrate Conductivity Cell A Calibrate according to calibration instructions in
Perform actions according to calibration instruc- the Service Manual, Calibration Manual.
tions in the Calibration Manual.
Calibrate Pressure transducer
Calibrate Conductivity Cell B Calibrate according to calibration instructions in
Calibrate according to calibration instructions in the Service Manual, Calibration Manual.
the Service Manual, Calibration Manual.
Occlusion
Calibrate Conductivity Cell P Calibrate according to calibration instructions in
Calibrate according to calibration instructions in the Service Manual, Calibration Manual.
the Service Manual, Calibration Manual.
Calibrate A/D conv.
Calibrate pH Calibrate according to calibration instructions in
Calibrate according to calibration instructions in the Service Manual, Calibration Manual.
the Service Manual, Calibration Manual.
Calibrate clock
Calibrate Pressure Transducer Calibrate according to calibration instructions in
Calibrate according to calibration instructions in the Service Manual, Calibration Manual.
the Service Manual, Calibration Manual.
Check fluid flow
Calibrate Bloodleak Start the machine and let it go to green path.
Calibrate according to calibration instructions in Press twice on the select button and check the
the Service Manual, Calibration Manual. fluid flow.

Calibrate Internal Pressure Regulator Calibrate variable flow


Calibrate according to calibration instructions in Calibrate according to calibration instructions in
the Service Manual, Calibration Manual. the Service Manual, Calibration Manual.

Fch
Start the machine and let it perform a Function
Check.

Heat disinfection
Perform a heating according to the Operators
Manual.

10:4 AK 95 / AK 95 S HCEN12078 Rev.10.2005

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Rel. pump speed, BiC:SRI(26),
Rel. pump speed, Ac: SRI(27)
B, Ac SRL(36) B MM 95 Bi-
Cart
Mixing Chamber Mixing Chamber
Feeding
A Pumps Cond. Cond.
SRL(35)
Cell "A" Cell "B"
A

AK 95 / AK 95 S HCEN12078 Rev.10.2005
FM Flow Diagram

SRL(7) = TRUE (Both connectors in the safety by-pass unit)


SRI(20) FLVA SRI(24) SRI(15) SRL(19)
SRL(8) = TRUE (Both connectors NOT in the safety by-pass unit) Rel. pump speed: SRI(22) T T (TRUE = Open)
SRL(18)
Fluid connector SRI(14)

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detection pH-SENSOR
(Optional)
RIVA SRL(21)
Safety by-pass SAGS SRI(31) SRI (59)* Degassing
P SRL(9) pressure
Unit DRVA Expansion
SAGS activated = TRUE M chamber transducer
SRL(33) REVA Treg SRI(13) *only active for machines
SRL(16) with variable flow P SRI(34)
INPS P (Pressure within Heater T Degassing
limits) Chamber
SRL(4)
Water Energized = TRUE
Inlet Pressure PR 2 INVA Flow Draining Flow
SRL(17) Heater duty cycle: SRI(11) Restrictor Pump Duty cycle: SRI(33)
regulator Flow Restrictor
(Inlet open) Current: SRI(32)
PR 1 °C switch SRL(3)
AIVA Flow = TRUE
SRL(34) Cond.
Suction Cell ”P” SRP(3)
Heat
Pump SRL(32)
exchanger ZEVA T SRP(2)
Drain SRI(53)
HPG SRI (17), Pressure
Blood Leak
Outlet P SRL(23), Alarm
Current: SRI(54) SRL(31) Detector
Restrictor
Duty cycle: SRI(55) EVVA UF-measuring
Draining
Restrictor Cell Taration timer:
UF-rate 2 1 SRI(39)
Level SRI(18) SRR(0) SRR(2) SRR(1)
Detector Deairating 0 = High
Chamber 1 = Mid
Pressure P 2 = Low
Dialysis
TMP (PD) SRL(24)
TAVA BYVA
SRP(1) SRP(4) SRL(27) DIVA
SRL(30)

Particle
Filter
Flow diagram
AK 95 S Dialyzer
Replacements

10:5
Replacements

This page is intentionally left blank

10:6 AK 95 / AK 95 S HCEN12078 Rev.10.2005

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Electrical Safety Inspections
for AK-machines
Including following sub-tests:
- Visual inspection
- PET - Protective earth test
- ELT - Earth leakage current test
- PLT - Patient leakage current test

HCEN12190 Rev 05.2006 Electrical Safety Inspections for AK-machines 11:1

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1 General information
To ensure proper operation, a qualified service technician must per-
form an Electrical Safety Inspection (ESI) of the AK-machine at reg-
ular intervals. The information needed to perform ESI is provided in
this manual.
Included in the ESI procedures are checks to verify normal machine
operation. Should the machine fail to pass any of these sub-tests, repair
or calibration might be needed, then repeat the tests until the specifica-
tions are met.
Following sub-tests are included in the ESI of the AK-machines:
- Visual inspection
- PET - Protective earth test
- ELT - Earth leakage current test
- PLT - Patient leakage current test
During the visual inspection of the equipment, the service engineer
shall look for potetial faults related to the electrical safety of the
machine.
The purpose of the PET test is to verify that the protective earthed parts
of the machine are properly connected to protective earth, providing a
safe low electrical potential on these in case of insulation failure.
The purposes of the ELT/PLT tests are to verify that non-functional
leakage currents to operator and patient are within safe limits.
ESI should be performed at every maintenance service (Base-service)
but also after replacements of some components in the AK-machine
according to the Service Manual, Chapter Replacements.
When performing the ESI, which requires access to the interior of the
machine, you must have proper electrostatic safety devices (i.e. wrist
grounding straps or grounding mats) in place to prevent damage to
electrostatic sensitive components within the machine.

During repair of any of the parts in the flow path, special care should
be taken and a good hygiene should be kept.
Checklists for each sub-test are included in the end of this manual. The
purpose of these checklists is to record the work done and to trend the
readings from the ELT/PLT- tests.

11:2 Electrical Safety Inspections for AK-machines HCEN12190 Rev 05.2006

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2 Visual inspection
The visual inspection is an important part of the electrical safety
inspections of the AK-machine.
The visual inspection is a procedure to make sure that the medical
equipment in use still confirms the specifications and has not suffered
from any external damage and/or contamination.
The visual inspection includes following steps:
1. Exterior parts including covers: look for major damages, cracks
etc.
2. Cablings: look for cuts, wrong connections etc.
3. Fuse rating: check correct values after replacement.
4. Markings and labeling: check the integrity
5. Integrity of mechanical parts: check for any visual obstructions

HCEN12190 Rev 05.2006 Electrical Safety Inspections for AK-machines 11:3

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3 PET - Protective Earth Test

NOTE
The machine shall not be connected to mains power during this test.

3.1 Test equipment for PET-test

Digital Multimeter:
Manufacturer: e.g. Fluke
Resistance: accuracy ± 0.5 %

3.2 PET for AK 95 / AK 95 S


1. Check that the resistance between the grounding clips of the
mains plug and the exterior cover of the power supply is
< 0.3 Ohm.
2. Check that the resistance between the grounding clips of the
mains plug and the heater rod is < 0.3 Ohm.

3. Check that the resistance between the grounding clips of the


mains plug and the suction pump is < 0.3 Ohm.

4. Check that the resistance between the grounding clips of the


mains plug and the mounting plate to the diascan conductivity
cell is < 0.3 Ohm.

5. Check that the resistance between the grounding clips of the


mains plug and the stand of MM 95 (e.g. a screw to the heat
exchangers) is < 0.3 Ohm.

6. Check that the resistance between the grounding clips of the


mains plug and the front of MM 95 (e.g. a screw to the BiCart-
holder) is < 0.3 Ohm.

7. Check that the resistance between the grounding clips of the


mains plug and the heparin pump (rear plate) is < 0.3 Ohm.

8. Check that the resistance between the grounding clips of the


mains plug and the potential equalization connector is
< 0.3 Ohm.

11:4 Electrical Safety Inspections for AK-machines HCEN12190 Rev 05.2006

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3.3 PET for AK 200 / AK 200 ULTRA / AK 200 S /
AK 200 ULTRA S
1. Check that the resistance between the grounding clips of the
mains plug and the power supply (right side, through the vent-
holes of the bottom box) is < 0.3 Ohm.
2. Check that the resistance between the grounding clips of the
mains plug and the FM bottom plate is < 0.3 Ohm.
3. Check that the resistance between the grounding clips of the
mains plug and the heater rods outside the heating vessel is <0.3
Ohm.
For 115 V machines: Also check that the resistance between the
grounding clips of the mains plug for the heater rods and the
heater rods outside the heating vessel is < 0.3 Ohm.
4. Check that the resistance between the grounding clips of the
mains plug and the overheat protection of the heater rods is
< 0.3 Ohm.
5. Check that the resistance between the grounding clips of the
mains plug and the potential equalization connector is
< 0.3 Ohm.

6. Check that the resistance between the grounding clips of the


mains plug and the heparin pump (rear plate) is < 0.3 Ohm.
Note! Don’t measure on the cable clip or its binding screw.

7. Check that the resistance between the grounding clips of the


mains plug and the rear plate of the BVS-unit is < 0.3 Ohm.

HCEN12190 Rev 05.2006 Electrical Safety Inspections for AK-machines 11:5

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4 ELT / PLT
4.1 Test equipment

Safety tester:
According to IEC 60601-1
Suggested Manufacturer: Metron, Rigel, Biotec

4.2 General conditions for ELT / PLT


1. The AK-monitor shall be connected to both feed water and drain.
2. Connect the AK-monitor to the outlet supply of the safety tester.
Use a mains plug adapter for respective mains plug. If the AK-
machine is equipped with two mains plugs, the measurements
shall be performed for each mains plug and the values shall be
added.

Safety
tester
Feed water AK-machine
mains prot. earth leakage current

earth enclosure

leakage current 230 VAC


alternative direct differential alternative
equipment patient

patient leakage current

Drain
lead to GND lead to lead AC/DC lead ISO
outlet power
Inlet Power

open E. open N. ev. M.

Mains voltage to
the AK-machine

3. Central concentrate delivery systems should not be used. Use


either liquid or non-liquid concentrates.
4. No other external equipment than specified in this instruction
should be connected to the machine.
5. The protective earth of the machine must not be in contact with
any external protective earth.

11:6 Electrical Safety Inspections for AK-machines HCEN12190 Rev 05.2006

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4.3 ELT - Earth Leakage Current Test
1. Let the machine pass FCH.
2. Measure the earth leakage current with the safety tester.
3. Take the highest reading when the machine is running.
4. Invert the phases of the mains voltage. The machine might
restart.
5. Take the highest reading when the machine is running.
6. Check that the highest measured readings don’t exceed the limit
values in following table:

Limit values for ELT


AK 95 S (100V) Max 500 µA
Typical < 100 µA
AK 95 S (110V) Max 500 µA
Typical < 125 µA
AK 200 S (115V)* Max 500 µA
Typical < 100 µA
AK 200 ULTRA S (115V)* Max 500 µA
Typical < 100 µA
AK 95 S (230V) Max 500 µA
Typical < 200 µA
AK 200 S (230V) Max 500 µA
Typical < 145 µA
AK 200 ULTRA S (230V) Max 500 µA
Typical < 145 µA

*The total earth leakage current is the sum of the readings from both
mains cables (to the heater rods and to the ACDC).

HCEN12190 Rev 05.2006 Electrical Safety Inspections for AK-machines 11:7

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4.4 PLT - Patient Earth Leakage Current Test

NOTE
Make sure that the machine does not perform a taration (self calibration)
during the measurements.

1. Let the machine pass FCH.


2. The safety couplings of the dialysis fluid tubes shall be con-
nected to the safety tester via an accesspoint.

Patient
leakage
current Safety
Dialysis fluid tubes tester
AK-machine
mains prot. earth leakage current

earth enclosure

230 VAC
Access-
leakage current

alternative direct differential alternative


equipment patient

patient leakage current

point lead to GND lead to lead

Inlet Power
AC/DC lead ISO
outlet power

open E. open N. ev. M.

Dialysis fluid tubes

Mains voltage to
the AK-machine

Note! There must be a main flow during this test. Check that the
Bypass button is switched off.

3. Measure the patient leakage current with the safety tester.


4. Take the highest AC-reading when the machine is running.
5. Take the highest DC-reading when the machine is running.
6. Invert the phases of the mains voltage. The machine might
restart.
7. Take the highest AC-reading when the machine is running.
8. Take the highest DC-reading when the machine is running.
9. Check that the highest measured readings don’t exceed the limit
values in following table:

Limit values for PLT


AC DC
AK 95 S (100V) Max 100µA Max 10µA
Typical <10µA
AK 95 S (110V) Max 100µA Max 10µA
Typical <10µA
AK 200 S (115V) Max 100µA Max 10µA
Typical <10µA
AK 200 ULTRA S (115V) Max 100µA Max 10µA
Typical <10µA
AK 95 S (230V) Max 100µA Max 10µA
Typical <10µA
AK 200 S (230V) Max 100µA Max 10µA
Typical <10µA
AK 200 ULTRA S (230V) Max 100µA Max 10µA
Typical <10µA

11:8 Electrical Safety Inspections for AK-machines HCEN12190 Rev 05.2006

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NOTE
For treatments with a central venous catheter (CVC), the patient leakage
current must be < 10µA

HCEN12190 Rev 05.2006 Electrical Safety Inspections for AK-machines 11:9

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11:10 Electrical Safety Inspections for AK-machines HCEN12190 Rev 05.2006

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5 Checklist
Electrical Safety Inspection for AK machines
- to be filed by the Service Engineer responsible

AK 95 / AK 95 S
AK 200 / AK 200 ULTRA / AK 200 S / AK 200 ULTRA S

Equipment ID:_______________Serial number:__________________


Run time (h):__________

Visual inspection
Visual inspection of the AK-machine according to section 2.

PET for AK 95, AK 95 S


(1) Resistance between the grounding clips of the mains plug and the exterior
cover of the power supply is < 0.3 Ohm.
(2) Resistance between the grounding clips of the mains plug and the heater
rod is < 0.3 Ohm.
(3) Resistance between the grounding clips of the mains plug and the suction
pump is < 0.3 Ohm.
(4) Resistance between the grounding clips of the mains plug and the mount-
ing plate to the diascan conductivity cell is < 0.3 Ohm.
(5) Resistance between the grounding clips of the mains plug and the stand
of MM 95 (e.g. a screw to the heat exchangers) is < 0.3 Ohm.
(6) Resistance between the grounding clips of the mains plug and the front
of MM 95 (e.g. a screw to the BiCart-holder)
(7) Resistance between the grounding clips of the mains plug and the heparin
pump (rear plate) is < 0.3 Ohm.
(8) Resistance between the grounding clips of the mains plug and the poten-
tial equalization connector is < 0.3 Ohm.

PET for AK 200, AK 200 ULTRA, AK 200 S, AK 200 ULTRA S


(1) Resistance between the grounding clips of the mains plug and the power
supply (right side, through the ventholes of the bottom box) is < 0.3 Ohm.
(2) Resistance between the grounding clips of the mains plug and the FM
bottom plate is < 0.3 Ohm.
(3) Resistance between the grounding clips of the mains plug and the heater
rods outside the heating vessel is <0.3 Ohm.
(4) For 115 V machines: Resistance between the grounding clips of the
mains plug for the heater rods and the heater rods outside the heating vessel
is < 0.3 Ohm.
(5) Resistance between the grounding clips of the mains plug and the over-
heat protection of the heater rods is < 0.3 Ohm.
(6) Resistance between the grounding clips of the mains plug and the poten-
tial equalization connector is < 0.3 Ohm.
(7) Resistance between the grounding clips of the mains plug and the heparin
pump (rear plate) is < 0.3 Ohm.
(8) Resistance between the grounding clips of the mains plug and the rear
plate of the BVS-unit is < 0.3 Ohm.

HCEN12190 Rev 05.2006 Electrical Safety Inspections for AK-machines 11:11

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ELT - Earth Leakage Current Test

File the highest earth leakage current value when the machine is running
according to section 4.3:
Earth leakage current value: _______ µA
Note!
Check that the highest measured readings don’t exceed the limit values
described in section 4:3

PLT - Patient Earth Leakage Current Test

File both the highest AC-reading and the highest DC-reading when the
machine is running according to section 4.4:
AC-reading: _______ µA
DC-reading: _______ µA
Note!
Check that the highest measured readings don’t exceed the limit values
described in section 4:4

Date:__________________________

Signature:_______________________

Other comments:
___________________________________________________________

___________________________________________________________

___________________________________________________________

___________________________________________________________

___________________________________________________________

11:12 Electrical Safety Inspections for AK-machines HCEN12190 Rev 05.2006

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AK 95 / AK 95 S · Service Manual

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