Documenti di Didattica
Documenti di Professioni
Documenti di Cultura
Service Manual
Contents:
Chapter 6 Calibrations
Chapter 10 Replacements
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
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
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
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
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
Line Fuses
Never overload the line fuses and do not supply
too many systems via a single line fuse.
Pressure:
1.2 - 6 bar to the pressure regulator mounted in
the MM 95. A
B
Acetate
Consumption in treatment:
AK 95 S: 500 ml/min
AK 95: 550 ml/min
AK 95 / AK 95 S Service Manual
1:3
HCEN 9133 Rev. 01. 2004
Water in
Drain
NOTE! The battery must be connected during
the installation according to the instruction on
next page.
BATTERY FAILURE
Change battery or press SELECT
Cover B
A Acetate
A A
Front
1070
AK 95 / AK 95 S Service Manual
1:5
HCEN 9133 Rev. 01. 2004
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
Step 2
180°
Step 3
Step 4
AK 95 / AK 95 S Service Manual
1:7
HCEN 9133 Rev. 01. 2004
Back-up Battery
The optional back-up battery is pre-assembled
under the monitor stand at delivery.
Fuse: T15 A
Running time: 30 minutes
AK 95 / AK 95 S Service Manual
1:9
HCEN 9133 Rev. 01. 2004
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.
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.
This record is to be signed and filed by the Service Engineer responsible for the installation.
Date............................Signature........................................................................
AK 95 / AK 95 S Service Manual
1:11
HCEN 9133 Rev. 01. 2004
Tel: +46 46 16 90 00
Fax: +46 46 16 96 96
www.gambro.com
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
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.
1002
Figure 1. AK 95 S.
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
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
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)
Particle
Filter
Flow diagram FIVA
SRL(56)
AK 95 S, UFD Dialyzer Ultrafilter
U 8000 S
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.
Heater
Conductivity cell P
Heater/
Flow switch
AIVA
REVA
INVA
Flow pump
RIVA
BYVA
DIVA FM I/O board
ZEVA
TAVA UF-measuring cell
Degassing chamber
Deairating chamber
Clamp house
Dialyzer connection
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
A
Feeding
Pump
B
A
Mixing
Chambers B
Heat
Exchanger
FLVA
A
Conductivity
Cell B
Figure 5. MM 95
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.
er
Protective Driv
boar d Contr
ol
board Driver
CPU
Protective Cont
ro
board boar l CPU
d
Blood Part
Blood Flow Diagram
Arterial pressure
P transducer (optional)
Arterial line
clamp
Arterial
pressure guard
Arterial blood
pump
Arterial blood
line
Venous blood
line
Venous drip
chamber
Priming
detector Air detector
Venous line
clamp
P
Venous pressure
transducer
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:
Component Description
3 4
5
7 2
1076
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
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
Operators panel
The operators panel is a flat surface panel. It
comprises:
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.
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
External fuses
12AH
12AH Filter MAINS to heater rod
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.
HCEN9369 Revision.10.2005
Program version 12.xx AK 95 S Service manual - Technical data and specifications 3:1
Downloaded from www.Manualslib.com manuals search engine
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
Single needle
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:
HCEN9369 Revision.10.2005
3:2 AK 95 S Service manual - Technical data and specifications Program version 12.xx
Downloaded from www.Manualslib.com manuals search engine
Blood pressure control
Venous pressure:
H CEN9369 Revision.10.2005
Program version 12.xx AK 95 S Service manual - Technical data and specifications 3:3
Downloaded from www.Manualslib.com manuals search engine
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
HCEN9369 Revision.10.2005
3:4 AK 95 S Service manual - Technical data and specifications Program version 12.xx
Downloaded from www.Manualslib.com manuals search engine
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
H CEN9369 Revision.10.2005
Program version 12.xx AK 95 S Service manual - Technical data and specifications 3:5
Downloaded from www.Manualslib.com manuals search engine
Formaldehyde Program (presetable)
Heat disinfection
HCEN9369 Revision.10.2005
3:6 AK 95 S Service manual - Technical data and specifications Program version 12.xx
Downloaded from www.Manualslib.com manuals search engine
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.
Without Heat 31 35 45
UFD
Heat CleanCart 43 48 58
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.
H CEN9369 Revision.10.2005
Program version 12.xx AK 95 S Service manual - Technical data and specifications 3:7
Downloaded from www.Manualslib.com manuals search engine
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.
HCEN9369 Revision.10.2005
3:8 AK 95 S Service manual - Technical data and specifications Program version 12.xx
Downloaded from www.Manualslib.com manuals search engine
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:
RS-422/Current loop:
Typ current: 20 mA
DC
Max current: 50 mA
DC
H CEN9369 Revision.10.2005
Program version 12.xx AK 95 S Service manual - Technical data and specifications 3:9
Downloaded from www.Manualslib.com manuals search engine
Battery back-up
Battery back-up of power 24 volt, 6,5 Ah
supply
Running time >30 minutes
Fuse T 15 A
HCEN9369 Revision.10.2005
3:10 AK 95 S Service manual - Technical data and specifications Program version 12.xx
Downloaded from www.Manualslib.com manuals search engine
Performance and specification - Supervisory
system
Blood pressure supervision
Venous pressure:
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.
H CEN9369 Revision.10.2005
Program version 12.xx AK 95 S Service manual - Technical data and specifications 3:11
Downloaded from www.Manualslib.com manuals search engine
Dialysis fluid preparation
Temperature:
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 )
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
HCEN9369 Revision.10.2005
3:12 AK 95 S Service manual - Technical data and specificat ions Program version 12.xx
Downloaded from www.Manualslib.com manuals search engine
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
H CEN9369 Revision.10.2005
Program version 12.xx AK 95 S Service manual - Technical data and specifications 3:13
Downloaded from www.Manualslib.com manuals search engine
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
Others
Carbon
Ceramic, Steatite 221
Ceramic, Aluminium oxide
(Al2O3)
Glass
HCEN9369 Revision.10.2005
3:14 AK 95 S Service manual - Technical data and specifications Program version 12.xx
Downloaded from www.Manualslib.com manuals search engine
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.
H CEN9369 Revision.10.2005
Program version 12.xx AK 95 S Service manual - Technical data and specifications 3:15
Downloaded from www.Manualslib.com manuals search engine
Standards
The machine complies with the following standards:
HCEN9369 Revision.10.2005
3:16 AK 95 S Service manual - Technical data and specifications Program version 12.xx
Downloaded from www.Manualslib.com manuals search engine
Technical Data
Chapter 3
Technical data and specifications for AK 95
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 %
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 %
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)
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
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.
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.
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.
Heat 33 37 47
Without UFD Heat Citric acid 20% 50 55 65
Heat CleanCart 46 51 61
Auto Heat disinfection: One of two alternatives for auto heat disinfection can be
selected.
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)
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.
1)
The normal distance can be mentioned i.e. at least 1.5 m
from the patient or the patient support.
Infusion stand
Maximum total load: 2 kg
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
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.
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.
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.
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
Yellow
Yellow
Orange Orange Green/Orange Bypass Green/Orange
Blood Set
flow
Set-knob; changes
a selected value
1)
OpCom=Operator’s Communication
2)
PTransducer= Protective system transducers.
Buf: 04 (07)
C COF 088 031 27 Oct 05 6:43
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.
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.
START
• To store values or modes, press UF
STOP
.
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
Select Service/Preset
MAINTENANCE SELECTION
Fch Preset Service
2. Press
4. Press
START
6. Press UF
STOP
to store the new value.
Note!
Use to step back in the preset menue.
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.
Partly
Partly default sets all values to default values
except the values for concentrates that remain
intact.
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
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
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 .
Dd Ee O o T t U u R r 4 # 5 +
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 .
8. Press to exit.
Acetate concentrate
Bicarbonate concentrate
BiCart
BiCart BiCart BiCart
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:
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
•In Internal AK 95 S
maintains a flow.
SELECT AD-CONVERTER
CPU C CPU P CPU W MM 95
Selection diagram
pH TRANSDUCER
VENOUS PRESSURE TRANSDUCER CPU C
CONDUCTIVITY A B P TRANSDUCER
CONDUCTIVITY A TRANSDUCER
CONDUCTIVITY P TRANSDUCER
CONDUCTIVITY B TRANSDUCER
See
“FM diagnostics”
See
“BM diagnostics”
DIAGNOSTICS SYSTEM MENU
COM I2C Errors
Name of the
transducer:
BM diagnostics
DIAGNOSTICS BM MENU
BPM Lamps Pumps Language
“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.
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
To regulate some useful parameters in Pump Diagnostics the following displays are available:
Temp
Temperature
TEMP LOW SET HIGH
23.2 00.0 37.5 90.0
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
DIAGNOSTIC FM MENU
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:
Logging mode
In the Logging mode it is possible to check the
condition and the status of both the hardware
and the software.
Shows program
See next page, version.
Error buffers in
Logging mode Shows total
run time
(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
Select Errors:
Buf: 01 (11)
C COFB 088 043 20 Oct 05 16:37
Arrays
Use the set knob to select the array type.
SRB
SRD
SRI
SRL
SRR
SRW
GAM
BRO
General
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)
Test equipment
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
* If installed
Parts
The Base-kit (K40182001) includes all parts
necessary to fulfill the mandatory preventive
maintenance procedures for AK 95 / AK 95 S.
Base-kit
Note!
As a complement to the Base-kit, three addi-
tional kits are available; A-, B- and C-kit.
100319061
100319060
05
06
07 10
08 09
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
100319008
100319008
100319008
100319050
05
06
07 10
08 09
05 10
06 09
07 08
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.
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.
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.
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.
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.
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.
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.
A-kit
Note!
All parts in the A-kit are possible to exchange
without opening the dialysis machine.
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
B
A A c e ta te
K40183001
K40184001
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.
A
B
A c e ta te Nuts
= Measuring
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
C-kit
K15235A
K21139003
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)
100335001
100335001
• 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.
Tel:+46 46 16 90 00
Fax:+46 46 16 96 96
www.gambro.com
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
Calibration AK 95 S
Warning! After completing the calibrations, the conductivity value must always be confirmed by the
hospital laboratory.
Ordering no:
UF - calibration:
UF-calibration box K21908002
AD:
Digital voltmeter
Priming detector:
A piece of blood tube used at the hospital.
Pressure
Reference instrument 300333001
Calibration kit K13983002
Special tool
For silicone tube connectors K12755001
Calibration kit
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.
SELECT AD-CONVERTER
CPU X AD-REF VOLTAGE STORED
CPU-C CPU-P CPU-W MM95
TP 5 TP2
Z0VAD
CPU C A/D ref
TP 6 Buzzer
(TP1)
CPU W PROM (TP2)
TP4 R24
Z0VRW
CPU W
SafeRAM
pH plug
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.
Selection diagram
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.
= Measuring
START
12. Press UF
STOP
to store the calibration values.
pH transducer calibration
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.
Offset Calibration:
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.
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
Fluid connector
detection
Water
Inlet Pressure PR 2 INVA
regulator Flow
PR 1 °C switch
AIVA
Heat Suction
exchanger Pump
Drain
Outlet
Restrictor
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.
High Level
AK
AK9590
S
V.ref.
UF
Low Level Cal.
Flow in/out Box
UFVA
Complete
3. Place B-pickup tube in the acetate-concentrate Then the display for Isolated UF Volume for 3
container. seconds:
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.
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:
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
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.
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
/
HCEN9094 Rev.10 .2005
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
/
HCEN9094 Rev. 10.2005
6 PT-screw 100366314
7 Level detector door K15114002
8 Shaft K17529001
9 Spring 100346026
10 Roller K12994001
/
HCEN9094 Rev.10 .2005
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
/
HCEN9094 Rev. 10.2005
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
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
/
HCEN9094 Rev.10 .2005
8
7
5
1
9
4 2
3 5
6 6
8 5
/
HCEN9094 Rev. 10.2005
/
HCEN9094 Rev.10 .2005
10
2 8
3
9
4,7
1,6
12
11
/
HCEN9094 Rev. 10.2005
9 Cabling K13054001
10 Cover sensor PCB K20112001
11 Screw 100378416
12 Roller K20891001
/
HCEN9094 Rev.10 .2005
8
7
6
9
2
4
5
10
1 3
11
/
HCEN9094 Rev. 10.2005
/
HCEN9094 Rev.10 .2005
8
4
5 1
6
2
/
HCEN9094 Rev. 10.2005
6 Screw 100378406
7 Housing K15765002
8 Piston Holder K15782002
/
HCEN9094 Rev.10 .2005
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
/
HCEN9094 Rev. 10.2005
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
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
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
19
1
3 2
7
8,12,16
9
10,11
4
6 5
15
14
13
17,18
/
HCEN9094 Rev. 10.2005
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
/
HCEN9094 Rev.10 .2005
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
/
HCEN9094 Rev. 10.2005
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
/
HCEN9094 Rev.10 .2005
8
10
14
17
7
11
9
16 2
4 15
13 1
21
3
12
18
6
9
19
20
/
HCEN9094 Rev. 10.2005
16 Cabling K13031001
17 Cabling K18189001 to Relay board P930
18 Carbon connector K21644001
19 Washer 100322010
20 Screw 100370314
21 Clip K08502001
/
HCEN9094 Rev.10 .2005
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
/
HCEN9094 Rev. 10.2005
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
41 O-ring 100319029
42 Pressure transducer K21400001 HPG
43 Washer K19013001
44 Tube no. 23909 K23909001
45 Tube no. 14 K12868001
/
HCEN9094 Rev.10 .2005
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
/
HCEN9094 Rev. 10.2005
6 O-ring 100319050
7 Screw 100370408
8 Connector, angled K12951001
9 O-ring 100319008
10 Distans screw 100316102
26 O-ring 100319007
27 Nipple K14158001
28 O-ring 100319056
29 Battery holder K18644001 incl. cabling
30 Washer K06180001
/
HCEN9094 Rev.10 .2005
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
/
HCEN9094 Rev. 10.2005
/
HCEN9094 Rev.10 .2005
12
1
2 11
10
4
8
13
3 6
/
HCEN9094 Rev. 10.2005
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
9 Screw 100389612
10 O-ring 100319042
11 Strap 100314068
12 Flow switch compl. K19835001
13 Cabling FK2 Priming K11412001
/
HCEN9094 Rev.10 .2005
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
/
HCEN9094 Rev. 10.2005
1 Screw 100378325
2 Screw 100378330
3 Valve membrane K08056C
4 Nut 100316082
5 Valve housing complete K16617A
11 Tube 100312056 30 mm
12 T-connector K12961001
13 Connector straight K10986001
14 Connector angled K12951001
15 Screw 100370405 locking fluid
/
HCEN9094 Rev.10 .2005
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
/
HCEN9094 Rev. 10.2005
1 Tube 100312032
2 Pressure regulator complete 100313252
3 Nippel K01515002
4 Tube 100312056 30 mm
5 Connector straight K10986001
11 Tube K15372001
12 Chamber complete K16884004
13 Strap 100314016
14 Tube no. 40 100312056 40 mm
15 Tube, silicone 100312032 to deairating chamber
21 Clamp 100334203
22 Strap 100314058
23 Tube no. 78 K19364001
24 Screw 100370405 locking fluid
25 Tube no. 50 K19567001
/
HCEN9094 Rev.10 .2005
2
to Step
driver board
8 1 7
4
3
5
12
13,14,15
4 9,10
11
6
/
HCEN9094 Rev. 10.2005
11 Motor K13403B
12 Valvehouse Spec. complete K24055001
13 Spacer K15049001
14 Washer 100322003
15 Spring 100346054
/
HCEN9094 Rev.10 .2005
Protective
7
1 9
2 4
3
8
e
Protectiv
/
HCEN9094 Rev. 10.2005
6 PT-screw 100368410
7 Screw 100370440
8 Screw 100370425
9 Fiber washer 100322049
/
HCEN9094 Rev.10 .2005
2 6
7
5
/
HCEN9094 Rev. 10.2005
/
HCEN9094 Rev.10 .2005
8 5
/
HCEN9094 Rev. 10.2005
/
HCEN9094 Rev.10 .2005
9
5
6
7
1 8
2 T12AH
250AC
HALT
BACH BACO
/
HCEN9094 Rev. 10.2005
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
/
HCEN9094 Rev.10 .2005
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
/
HCEN9094 Rev. 10.2005
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
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
31 Cabling K18136001
32 Tube no. 44 K17798001 to heat exchanger
33 Tube no. 43 K17764001
/
HCEN9094 Rev.10 .2005
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
/
HCEN9094 Rev. 10.2005
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
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
/
HCEN9094 Rev.10 .2005
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
/
HCEN9094 Rev. 10.2005
6 Holder K20194001
7 Holder K16276001
8 Clamp 100334203
9 Tube armoured 100312093 260 mm
10 Tube armoured 100312093 85 mm
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
/
HCEN9094 Rev.10 .2005
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
/
HCEN9094 Rev. 10.2005
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
/
HCEN9094 Rev.10 .2005
10
6
9 7
/
HCEN9094 Rev. 10.2005
/
HCEN9094 Rev.10 .2005
15
18
14
16
10
18
7
10 19
2
6
3
4
5
20 7
13 12
9
11
14
17
8
/
HCEN9094 Rev. 10.2005
6 Screw 100378408
7 Tube, soft 100312012
8 Tube, silicone 100312032 100 mm
9 Nipple K01515002
10 Tube, silicone 100312032 300 mm
/
HCEN9094 Rev.10 .2005
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
/
HCEN9094 Rev. 10.2005
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
26 Membrane K08056C
27 Washer K21486001
/
HCEN9094 Rev.10 .2005
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
/
HCEN9094 Rev. 10.2005
11 T- Connector K12961001
12 Connector, angled K12951001
13 Screw 100370408
14 Tube, santoprene 100312141 310 mm
/
HCEN9094 Rev.10 .2005
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
/
HCEN9094 Rev. 10.2005
16 O-ring 100319008
17 O-ring 100319046
18 Tube, silicone 100312032 140 mm
19 Protective ring K22829001
/
HCEN9094 Rev.10 .2005
18 1 6 11 16 8 10
13
14
4 5 7 17 12 9 6
2 6 19 15
/
HCEN9094 Rev. 10.2005
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
/
HCEN9094 Rev.10 .2005
11
13
4 5 9 10
3
2
1
22
23
24
25
26 19,20,21
/
HCEN9094 Rev. 10.2005
11 Holder K23046001
12 Screw 100385408
13 Rear panel K23191A
14 Washer 100322049
15 Gasket K23045001
21 Screw 100316093
22 Screw 100378406
23 Baffle plate K23192001
24 Screw 100378316
25 Cable holder K23190001
/
HCEN9094 Rev.10 .2005
EN1107
/
HCEN9094 Rev. 10.2005
/
HCEN9094 Rev.10 .2005
EN1107
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
/
HCEN9094 Rev.10 .2005
Tel: +46 46 16 90 00
Fax: +46 46 16 96 96
www.gambro.com
SymbolDescription
NOTE
All symbols in this list may not be represented on this product.
Description
Alternating current
This way up
Keep dry
Input /Output
Year of manufacturing
Prohibited behaviour
Equipotentiality
Replacements
Replacement matrix...................................... 2
Changeactions ..................................................... 4
FM Flow Diagram ............................................... 5
Replacement matrix
The actions to carry out after a component
replacement are brought together in a replace-
ment matrix.
AK 95 / AK 95 S HCEN12078 Rev.10.2005
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
Fch
Start the machine and let it perform a Function
Check.
Heat disinfection
Perform a heating according to the Operators
Manual.
AK 95 / AK 95 S HCEN12078 Rev.10.2005
FM Flow Diagram
Particle
Filter
Flow diagram
AK 95 S Dialyzer
Replacements
10:5
Replacements
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.
NOTE
The machine shall not be connected to mains power during this test.
Digital Multimeter:
Manufacturer: e.g. Fluke
Resistance: accuracy ± 0.5 %
Safety tester:
According to IEC 60601-1
Suggested Manufacturer: Metron, Rigel, Biotec
Safety
tester
Feed water AK-machine
mains prot. earth leakage current
earth enclosure
Drain
lead to GND lead to lead AC/DC lead ISO
outlet power
Inlet Power
Mains voltage to
the AK-machine
*The total earth leakage current is the sum of the readings from both
mains cables (to the heater rods and to the ACDC).
NOTE
Make sure that the machine does not perform a taration (self calibration)
during the measurements.
Patient
leakage
current Safety
Dialysis fluid tubes tester
AK-machine
mains prot. earth leakage current
earth enclosure
230 VAC
Access-
leakage current
Inlet Power
AC/DC lead ISO
outlet power
Mains voltage to
the AK-machine
Note! There must be a main flow during this test. Check that the
Bypass button is switched off.
AK 95 / AK 95 S
AK 200 / AK 200 ULTRA / AK 200 S / AK 200 ULTRA S
Visual inspection
Visual inspection of the AK-machine according to section 2.
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
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:
___________________________________________________________
___________________________________________________________
___________________________________________________________
___________________________________________________________
___________________________________________________________