Professional Documents
Culture Documents
Dialysis Machine
Service Manual
Order number:
MHCEN9281-03/16
Copyright
Copyright 2001-2003, 2005, 2007, 2009, 2010, 2012, 2016 Gambro Lundia AB.
Trademarks
Gambro, AK 200 S, AK 200 ULTRA S, BiCart, BiCart Select, CleanCart, Diascan, Exalis,
SelectBag, and SelectCart are trademarks belonging to the Gambro Group.
PEEK is a trademark of Victrex plc.
Dialox is a trademark of L'Air Liquide.
Manufacturer
Gambro Lundia AB
Box 10101
Magistratsvgen 16
SE-220 10 LUND
Sweden
Phone +46 46 169000
www.gambro.com
Sales representative contact information, (if applicable):
Questions or comments about this publication can be directed to your local representative or to the
manufacturer.
1.2 Installation...................................................................................................................... 2
1.5 Maintenance................................................................................................................... 3
4 Replacements ........................................................................................................................ 74
7.4 Materials in contact with water, concentrates and dialysis fluid ......................... 167
7.4.1 Polymers................................................................................................................ 167
7.4.2 Metals .................................................................................................................... 167
7.4.3 Others.................................................................................................................... 167
8 Technical data and specifications - AK 200 ULTRA S dialysis machine .................... 172
8.4 Materials in contact with water, concentrates and dialysis fluid ......................... 184
8.4.1 Polymers................................................................................................................ 184
8.4.2 Metals .................................................................................................................... 184
8.4.3 Others.................................................................................................................... 184
1.2 Installation...................................................................................................................... 2
1.5 Maintenance................................................................................................................... 3
NOTE!
This Service Manual is intended to be used for both AK200S and AK200ULTRAS
dialysis machines.
AK200ULTRAS Service manual, HCEN9291, will therefore be replaced by this
manual.
1.2 Installation
Installation of the machine should be done in accordance with the recommended
procedures in the AK 200 S / AK 200 ULTRA S - Installation guide, HCEN9282.
When installing a new monitor please ensure proper reporting in Gambros global
electronical service reporting system whether there are any deviations or not. This is
important information and it will assist us to improve the product for you.
1 General information
person authorized by Gambro, fulfilling the specified qualifications stated in the Section
1.6 Competence of Service Engineers on page3.
1.3 Complaint
If a complaint is raised it shall be communicated to the relevant Gambro Sales
Company. In order for the Sales Company to be able to determine the relevance of a
complaint, it is of vital importance that the deviation is communicated to them as
comprehensive as the issue requires.
Complaints are important information and it will assist Gambro to improve the product
for you. The Complaint system is not valid for products, components or printed circuit
boards that isn't in its original delivered condition.
1.4 Disclaimer
The manufacturer accepts responsibility for the safety, reliability, and performance of
this equipment only if installation, operational procedures, maintenance, calibrations,
and repairs are carried out by appropriately trained and suitable qualified people; if all
equipment modifications are authorized in writing by the manufacturer and carried out
by appropriately trained and suitable qualified people; if the electrical installation of the
relevant room complies with all applicable local electrical codes and, if applicable, IEC
requirements; and if the equipment is used in accordance with the published
AK 200 S / AK 200 ULTRA S - Operators Manual.
1.5 Maintenance
To ensure proper operation of the AK 200 S / AK 200 ULTRA S dialysis machine, a
qualified service technician must perform a complete series of maintenance
procedures at regular intervals.
The maintenance and calibration information that you need to use is provided in this
Service Manual, refer to chapters Maintenance Manual and Calibrations.
It is mandatory to perform at least a preventive maintenance every second year. A
yearly maintenance is recommended. The rate of preventive maintenance might be
different due to variations of the operating environment.
1.7 Repair
Parts which are sent for repair shall be sent to the following address:
Baxter / Gambro Lundia AB
Repair Shop
Scheelevgen 34
223 63 LUND
SWEDEN
Type B, applied part (the extracorporeal circuit and the dialysis fluid circuit).
1 General information
Input /Output.
Prohibited behaviour.
Equipotentiality.
This symbol indicates that the AK 200 S / AK 200 ULTRA S dialysis machine contains
toxic or hazardous substances or elements according to SJ/T 113632006.
The figure 25 indicates the corresponding environmental protection use period of the
AK 200 S / AK 200 ULTRA S dialysis machine.
The AK 200 S / AK 200 ULTRA S dialysis machine is protected against dripping water.
Catalogue number.
Serial number.
Humidity limitation. Upper and lower limit is expressed with numeric values in %.
Atmospheric pressure limitation. Upper and lower limit is expressed with numeric values
in kPa.
Temperature limitation. Upper and lower limit is expressed with numeric values in degree
Celsius or Fahrenheit.
The maximum stacking load permitted on the transport package.
Do not stack.
2 Installation Guide
2.1.2 Tools
Recommended tools needed for installation of AK 200 S / AK 200 ULTRA S dialysis
machine:
Phillips screwdrivers:
PH 2, length 100 mm
PH 2, length 250 mm
Flat screwdriver:
1 x 5.5 length 175 mm
Hexagon socket wrench (e.g. flex headed spanners HEX, Metric)
7 mm
13 mm
17 mm
Set of hexagon head keys
Cutting pliers
Tube cutter, e.g. 113500084
2.1.3 Manufacturer
Gambro Lundia AB
Box 10101
Magistratsvgen 16
SE-220 10 LUND
Sweden
Phone +46 46 169000
www.gambro.com
NOTE!
The 115 V-version require two grounded power sockets within 3.0 metres.
All leakage currents are specified without external equipment connected to the
machine.
2 Installation Guide
2.3.4 Line Fuses
Never overload the line fuses and do not supply too many systems via a single line
fuse.
NOTE!
If a high frequent noise appears from the pressure regulator, do a small adjustment
of it up or down. (85 - 120 kPa)
Inlet Water Temperature
Treatment +5 to +30 C
Disinfection +5 to +90 C
NOTE!
Local ordinances may require the use of special measures to protect against the
possibility of back-siphonage from dialysis equipment into the water supply. An air
gap to atmospheric pressure must always be arranged at the tube outlet. The drain
tube should not exceed 5 metres in length.
2 Installation Guide
2.6 Batteries
2.6.1 9 V Battery
The rechargeable 9 V battery, mounted inside the blood monitor, is used for the buzzer
alarm during main's power failure. The battery is not connected at delivery.
NOTE!
This battery must be connected during the installation. Refer to Section 2.9
Installation instructions for AK 200 S dialysis machine on page27 for AK 200 S
dialysis machine and Section 2.10 Installation instructions for AK 200 ULTRA S
dialysis machine on page31 for AK 200 ULTRA S dialysis machine.
A discharged battery will be charged with maximum 12 mA and it must be charged for
at least 50 hours to get completely charged. An fully charged battery will receive a
maintaining current of approximately 1.5 mA. AK 200 S / AK 200 ULTRA S dialysis
machine charges the battery as long as the power supply is switched on, i.e.
AK 200 S / AK 200 ULTRA S dialysis machine itself does not need to be switched on.
The battery is tested during every functional check to ensure that the capacity is
enough in the battery, otherwise an attention will be given:
WARNING!
Jumper J11 on the BM CPU board must be mounted for the rechargeable battery. If
use of an alkaline non-rechargeable battery, jumper J11 must be removed, if not, the
battery will be damaged.
2 Installation Guide
Fuse: T15 A
Running time: 15 minutes
The charge indicator on the power supply is lit when the AK 200 S / AK 200 ULTRA S
dialysis machine is equipped with the back-up battery. The machine must be
connected to mains voltage and the mains switch must be on.
In a mains failure situation the following attention will be given.
2.7.1 General
The monitor stand MS 200 or MS 202 is partly preassembled at delivery. The items to
be mounted during installation are:
Lower frame, cover, pillar and upper frame
Battery back-up kit and transformer
Earth connections
Lift control kit
Remote control cable
Infusion stand holders
Filter holders
1) Step 1
2 Installation Guide
NOTE!
This can also be done after
the lower frame has been
fastened, Step 4, Item 1.
2) Step 2
1. Adjust the height of the MS 200. Select
the desired position by using the
height adjustment screws.
MS 200 can be adjusted in five
different positions: total height
including the AK monitor is 1152 to
1382 mm.
2. Turn the pillar upside-down.
3. Put a thin string silicone on the lower
edge of the pillar. Remove all
unwanted silicone with a cloth.
NOTE!
Be careful to match the parts
exactly to get the correct
passing at once (due to the
silicone).
Be careful not to damage the
2 Installation Guide
earth cable and the battery
cable when placing the parts
together.
4) Step 4
1. Fasten the lower frame (cover
included) to the pillar with four
hex-head screws (100382030), with a
hexagon socket wrench.
2. Assemble the holder for the infusion
pole with two screws (100388812).
3. Assemble the connector with two
screws (100370410).
NOTE!
Before mounting the
connector, remove two pins.
5) Step 5
1. Assemble the battery back-up kit
(K18652001) to the lower frame of the
stand with two screws (100388410).
2. Connect the battery cable to the
battery back-up.
3. Strap the battery cable to the bar.
7) Step 7
1. Fasten the upper frame to the pillar
with four screws (100389903).
2. Fasten the bracket for the dialysis fluid
filter holder and Water filter holder. Use
four screws (100388510).
2 Installation Guide
three screws (100378530).
1) Step 1
1. Place the lower frame of the stand
upside-down.
2. Attach the grounding sign beside the
earth screw.
3. Assemble the earth cable to the earth
screw.
4. Thread the earth cable and the battery
cable through the cable entry of the
lower frame.
5. Loosen the four screws and remove
the battery holder, according to the
illustration.
3) Step 3
1. Place the lower frame (cover included)
on the pillar.
NOTE!
Be careful to match the parts
exactly to get the correct
passing at once (due to the
silicone).
Be careful not to damage the
earth cable and the battery
cable when placing the parts
together.
2 Installation Guide
NOTE!
Before mounting the
connector, remove two pins.
5) Step 5
1. Move the back-up batteries (1a)1 from
the holder included in the battery back-
up kit (K18652001) to the battery holder
adjusted for WRO 300 / WRO 300 H
(1b) according to the illustration.
NOTE!
Do not disconnect the cables
from the batteries, fuse
holder or the contact.
2. Mount the contact for the battery cable
and the fuse holder to the battery
holder.
3. Fasten the printed circuit board to the
battery holder with the adhesive quick
lock.
NOTE!
The electrical installation of
the back-up batteries must
remain according to the
diagram on the battery
holder.
1 including cables, fuse holder, contact for the battery cable and printed circuit board
7) Step 7
1. Attach the grounding sign beside the
earth screw.
2. Assemble the earth cable to the earth
screw.
3. Separate the rubber casing on the
battery cable (5 cm) and put it in the
opening of the upper edge.
4. Insert the sealing grommet in the
opening of the short side upper edge.
(It is used for the power supply cord to
the electrically adjustable stand, MS
202)
2 Installation Guide
9) Step 9
The filter holder to the right is used for
dialysis fluid filters.
The left filter holder is used for Water filters
(AK200ULTRAS dialysis machine only).
1. Fasten the filter holder to the right with
three screws (100378530).
2. AK200ULTRAS dialysis machine
only: Fasten the left filter holder with
three screws (100378530).
NOTE!
Use the adaption kit
2 Installation Guide
1) Step 1
1. Place the lower frame of the stand
upside-down.
2. Insert and rotate the lift control kit by
lifting the lower frame.
3. Attach the grounding sign beside the
earth screw.
4. Assemble the earth cable to the earth
screw.
5. Thread the earth cable and the battery
cable through the cable entry of the
lower frame.
NOTE!
This can also be done after
the lower frame has been
fastened (Step 4, Item 1).
NOTE!
MS 202 is variable adjustable
in height. Total height
2 Installation Guide
including the AK-monitor is
1175 to 1340 mm.
3) Step 3
1. Place the lower frame (cover included)
on the pillar.
NOTE!
Be careful to match the parts
exactly to get the correct
passing at once (due to the
silicone).
Be careful not to damage the
earth cable and the battery
cable when placing the parts
together.
4) Step 4
1. Fasten the lower frame (cover
included) to the pillar with four
hex-head screws (100382030), with a
hexagon socket wrench.
2. Connect the motor cable to the lift
control kit.
3. Connect the power cable from the lift
control kit to the battery back-up.
4. Connect the remote control cable to
the lift control kit.
2 Installation Guide
screw.
4. Separate the rubber casing on the
battery cable (5 cm) and put it in the
opening of the upper edge.
5. Lead the remote control cable through
the stand and through the bottom hole.
WARNING!
Beware of the
movement/rotation and the
sharp edges of the pillar.
6. Attach the remote control cable to the
lift control kit.
7. Cut the sealing grommet. Use ethanol
to simplify the assembly.
8. Insert the sealing grommet in the
opening of the short side upper edge
and stretch the cable according to the
maximum height of the stand.
9. Lower the pillar with the remote
control.
8) Step 8
The filter holder to the right is used for
dialysis fluid filters.
The left filter holder is used for Water filters
(AKULTRAS dialysis machine only).
1. Fasten the filter holder to the right with
three screws (100378530).
2. AK200ULTRAS dialysis machine
only: Fasten the left filter holder with
three screws (100378530).
2 Installation Guide
NOTE!
Observe that the plugged tubes from the fluid monitor at the bottom of the
machine fit into the holes in the stand.
2 Installation Guide
UFD-kit)
1. Attach angled connectors to the tubes
coming from the fluid monitor.
Attach angled connectors to the
dialysis fluid filter holder.
Connect tube 132, 133 and 134 from
the dialysis fluid filter holder to the
tubes coming from the fluid monitor,
according to these figures.
2. Strap the tubes.
3. Insert a new ultrafilter into the dialysis
fluid filter holder according to
instructions in the AK200S Operator's
Manual.
2) Step 2 - pH-sensor
1. If a pH-sensor is to be installed,
remove the pH dummy and insert the
pH-sensor.
NOTE!
pH-sensor calibration
If the machine is equipped
with the pH-sensor option,
this must be calibrated during
installation. Ref. to
AK200S/AK200ULTRAS
Service Manual, chapter
Calibration manual.
It is important that the
pH-sensor is calibrated when
the dialysis machine is
installed, since the delivered
pH meter has not been
calibrated with the actual
machine.
2 Installation Guide
6) Step 6 - BM - 9 V battery
WARNING!
Jumper J11 on the BM CPU
board must be mounted for
the rechargeable battery. If
use of an alkaline
non-rechargeable battery,
jumper J11 must be
removed, if not, the battery
will be damaged.
WARNING!
The mains power cable from
the AK200S dialysis
machine must be plugged
into a socket with Protective
Earth (PE) to avoid risk of
electrical shock.
NOTE!
The 115 V-version require
two grounded power sockets
within 3.0 metres.
The mains power should be
be supplied by a unique fuse
group from the main central.
Ensure that other equipment
connected to the same
central does not load the
voltage supply in a manner
that decreases the supplied
voltage to levels outside the
limits.
2 Installation Guide
Connect tube 132, 133 and 134 from
the dialysis fluid filter holder to the
tubes coming from the fluid monitor,
according to these figures.
2. Insert a new ultrafilter into the dialysis
fluid filter holder according to
instructions in the AK 200 ULTRA S
Operators Manual.
3. Insert a new ultrafilter into the dialysis
fluid filter holder according to
instructions in the AK 200 ULTRA S
Operators Manual.
2) Step 2 - pH-sensor
1. If a pH-sensor is to be installed,
remove the pH dummy and insert the
pH-sensor.
NOTE!
pH-sensor calibration
If the machine is equipped
with the pH-sensor option,
this must be calibrated during
installation. Ref. to
AK200S/AK200ULTRAS
ServiceManual, chapter
Calibration manual.
It is important that the
pH-sensor is calibrated when
the dialysis machine is
installed, since the delivered
pH meter has not been
calibrated with the actual
machine.
2 Installation Guide
6) Step 6 - BM - 9 V battery
WARNING!
Jumper J11 on the BM CPU
board must be mounted for
the rechargeable battery. If
use of an alkaline
non-rechargeable battery,
jumper J11 must be
removed, if not, the battery
will be damaged.
WARNING!
The mains power cable from
the AK200ULTRAS dialysis
machine must be plugged
into a socket with Protective
Earth (PE) to avoid risk of
electrical shock.
2 Installation Guide
voltage supply in a manner
that decreases the supplied
voltage to levels outside the
limits.
NOTE!
Ensure that the voltage specified on the voltage tag matches the mains voltage. If in
doubt, please contact your Gambro Service representative.
The main switch on the power supply should always be in ON position, even when
the AK 200 S / AK 200 ULTRA S dialysis machine is not in use. This Stand by
mode is indicated by a lit segment on the TIME display on the Operator's panel.
Procedure
1) Press the ON/OFF button for 3 seconds.
2) Preset the machine according to the clinics demand. Refer to
AK 200 S / AK 200 ULTRA S - Service Manual, chapter: Maintenance support
description / Preset mode.
3) pH-sensor calibration:
If the AK 200 S / AK 200 ULTRA S dialysis machine is equipped with the
pH-sensor option, this must be calibrated during installation. Refer to the
AK 200 S / AK 200 ULTRA S Service Manual, chapter Calibration manual, pH
sensor calibration.
NOTE!
It is important that the pH-sensor is calibrated when the
AK 200 S / AK 200 ULTRA S dialysis machine is installed, since the delivered
pH-meter has not been calibrated with the actual machine.
NOTE!
Each time the AK 200 S / AK 200 ULTRA S dialysis machine is started, the
automatic functional check, Fch, is carried out. This check requires that the
dialysis fluid tubes are connected to the safety bypass unit. The dialysis fluid
tubes must remain connected to the safety bypass unit until Fch has
disappeared from the time display.
WARNING!
After completing the installation process the composition of the dialysis fluid
should be confirmed in laboratory tests according to local regulations, before the
AK 200 S / AK 200 ULTRA S is ready for use. This is the responsibility of the
physician.
2 Installation Guide
Serial number
FM: ____________________ BM: ____________________
Monitor Stand
Ensure that the Monitor Stand is assembled correctly according to the instructions
for MS 200, MS 200 - WRO 300 / WRO 300 H or MS 202.
MS 200
Step 1 Step 5
Step 2 Step 6
Step 3 Step 7
Step 4 Step 8
MS 202
Step 1 Step 5
Step 2 Step 6
Step 3 Step 7
Step 4 Step 8
2 Installation Guide
Adjust inlet pressure regulator.
Functional check.
Heat disinfection.
Re-tighten the nuts of the of the dialyzer connector set to the machine.
Perform a simulated treatment (recommended)
Dialysis fluid sample submitted for analysis (recommended)
NOTE!
If you have any remarks during installation, please contact your Gambro Service
representative.
This record is to be signed and filed by the Service Engineer responsible for the initial
installation and start-up procedure of this AK 200 S / AK 200 ULTRA S dialysis
machine.
3 Maintenance manual
by Gambro with respect to the AK 200 S / AK 200 ULTRA S dialysis machine are void
if the equipment is not used in accordance with the instructions provided. Gambro will
not accept responsibility for any damage or injury resulting from improper use or
maintenance or unauthorized repair.
To fulfil the preventive maintenance procedures for AK 200 S / AK 200 ULTRA S
dialysis machine some parts must be exchanged. The necessary parts to be
exchanged are available in one Base-kit and two complementary kits:
Base-kit (K40165001)
A-kit (K40166002): Includes exterior parts
B-kit (K40167001): Overhauling service-kit
When performing preventive maintenance procedures or calibrations, which require
access to the interior of the machine, you must have proper electrostatic safety
devices (i.e. wrist grounding straps or grounding mats) in place to prevent damage to
electrostatic sensitive components within the machine.
During repair of any of the parts in the flow path, special care should be taken and a
good hygiene should be kept.
NOTE!
After maintenance a disinfection program must be performed before a treatment is
performed.
Checklists are provided in the Spare Parts Instruction that is included in the
maintenance kits. The purpose of these checklists is to record the work done.
3 Maintenance manual
lower (50m)
10 FM Filter after the K16538C 1
SelectBag
container holder
(50m)
11 FM Filter heating K14944001 1
vessel (250m)
12 FM V-ring heating 100318086 2
vessel
13 FM Membrane for K40153001 1
internal pressure
regulator
14 FM Membrane for K17989001 1
non-return valve
15 FM Sample port for 6 K20219002 1
mm tube
16 FM Sealing ring (Inlet K07994001 1
unit - heating
vessel)
16 FM Ring (Inlet unit - K08227001 1
heating vessel)
17 FM Sealing for K18184001 1
substitution fluid
port
18 FM Label K24092001 1
NOTE!
As a complement to the Base-kit, two additional kits are available; A- and B-kit.
NOTE!
3 Maintenance manual
This information is for step 8
to 10: To prevent that air is
getting trapped inside the
particle filters (50 m), it is
important that the particle
filters are correct positioned
according to this figure.
3 Maintenance manual
15) Change the sample port.
3.3.1.3 Actions to carry out after the parts have been exchanged
Procedure
1) Check that the screws for the blood pump(s) are tightened.
3 Maintenance manual
3) Check that the wheels are tightened.
should be > 1 M. The machine must be empty and switched off during
measurement.
8) Erase the error code buffers. Enter service menu > Diagnose > System >
Errors > Erase
3 Maintenance manual
Start the AK 200 S / AK 200 ULTRA S dialysis machine with the main switch
and the ON/OFF button.
Enter Service mode, Diagnose / BM / Others and BPM
BPM sub-tests
Following sub-tests are included:
Air leakage test: measures that the equipment is airtight.
Inflation speed test: measures the time to fill the cuff with air.
Static pressure: Check of pressure transducer calibration
Each of the tests can be carried out separately but the above order for
carrying out the sub-tests is recommended.
Check that the results from the sub-tests not exceed following limits:
Air leakage: maximum 18 mmHg / 3 min.
Inflation speed: 2 - 11 s
Static pressure: Maximum deviation from reference to be within 3 mmHg.
50 3 mmHg
150 3 mmHg
250 3 mmHg
NOTE!
The pressure transducer calibration tube kit must be drained before being
3 Maintenance manual
connected, to make sure that no fluids or particles enters the BPM connector or
tubings. This might otherwise damage or destroy the sensitive BPM sensors.
NOTE!
The BPM is equipped with an over pressure protection. It is activated for
pressures above 300 mmHg.
The pressure transducer test is to be performed within approx. 2 minutes. Then
the pressure is automatically released.
e) Insert an empty reference tube in the priming detector. The reference tube
shall be from the same type of blood line as used during treatment.
3 Maintenance manual
b) Set the display to:
NOTE!
When creating a positive pressure in the venous drip chamber, a more
treatment like condition is simulated as the pressure inside the drip chamber
becomes approximately the same as the venous pressure during treatment.
The purpose is to get a better contact between the chamber and the air
detector head, which results in a higher calibration value.
f) Wait for 2 minutes and then press the lit Arrow button
g) The calibration is now performed automatically and the calibration factor is
written into the EEPROM.
h) The calibration result is displayed:
The value under LEVEL is the new alarm limit, which shall be 50 or higher.
The value under TRANSMIT is the transmission level, which is normally 255
but can also be 160, if the air detector is exceptionally good.
Check surface on the roller at the pump rotor, if it is damaged exchange the
unit.
The roller unit should easily go back to upper end position when it has been
pressed down to end position. Exchange unit if it gets stuck in any position.
NOTE!
If the pump segment has a different wall thickness, the occlusion of the pump
must be adjusted to the correct wall thickness.
Use the gauge pins (stop/go) available in the kit K40158001. The kit includes
following three different gauge pins:
T = 1.1 (Stop pin = 1.1x2x0.7 = 1.5mm)
T = 1.6 (Stop pin = 1.6x2x0.7 = 2.2mm)
T = 2.0 (Stop pin = 2.0x2x0.7 = 2.8mm)
T = wall thickness of the tubing
Use following formula to calculate which gauge pin to use: 2 x wall thickness x 0,7
(mm)
3 Maintenance manual
NOTE!
Put grease on the GO and STOP pins when not used and store the pins in a
plastic ba to prevent them from corroding.
14) Enter Service / Calibr / BM and set the AK 200 S / AK 200 ULTRA S display
to:
16) Enter Service / Calibr / BM and set the AK 200 S / AK 200 ULTRA S display
to:
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17) Enter Diagnose / BM / Pumps and check that the blood pump(s) stops when the
cover is opened.
19) Enter Service / Calibr / FM and set the AK 200 S / AK 200 ULTRA S display
to:
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21) Enter Service / Calibr / FM and set the AK 200 S / AK 200 ULTRA S display
to:
22) Enter Service / Calibr / FM and set the AK 200 S / AK 200 ULTRA S display
to:
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24) Enter Service / Calibr / FM and set the AK 200 S / AK 200 ULTRA S display
to:
25) If installed: Calibrate the pH-sensor (FM 13) with a buffer solution. (see chapter
Calibration manual for details).
26) Check the blood leak detector limits: 0 and 100 10.
a) Remove the blood leakage detector cover and clean the inside of the blood
leakage detector housing.
b) Mount a blood leakage calibration cover (K40169001). Make sure that the
filter is in horizontal position.
c) Enter the Service menu.
d) In service mode, select calibration, FM, intern and Blood Leakage Detector
(FM 24).
e) Let the machine stabilize at 37 C. No concentrate shall be used.
f) Press the Start UF Stop button to enter the blood leakage calibration routine.
g) Check the blood leak detector limits 0 and 100 10. Calibrate if necessary
(see chapter Calibration manual for details).
h) Drain the AK 200 S / AK 200 ULTRA S dialysis machine and remount the
standard blood leakage cover.
i) Enter the Service menu.
j) In service mode, select calibration, FM, intern.
3 Maintenance manual
28) Check the conductivity indications, at approximately 14 mS/cm.
Place A-pick up tube in concentrate container and let it stabilise for 15 minutes.
Use GXL fluid monitor screen and a reference instrument connected to the
dialysis fluid tubes.
The indicated conductivity values in GXL should correspond to the indication on
the reference instrument. The maximum deviation is 0.1 mS/cm.
29) Check the temperature indications, at approximately 37 C.
Use GXL fluid monitor screen and a reference instrument connected to the
dialysis fluid tubes.
The indicated temperature value (at the conductivity cell 2, guard) should
correspond to the indication on the reference instrument. The maximum deviation
is 1.5 C.
If the deviation is more than the stated tolerance; the affected temperature
transducer must be exchanged.
30) Place A-pick up tube back into the heating vessel and wait for 5 minutes. Place
the B-pick up tube in the concentrate container. Enter Service menu, Calibr /
FM / Other / UF / Restr. Perform an FRN calibration.
31) Let the machine pass Fch. Check the DC leakage between TP 7 (Z0VL) on the
Power distribution board and the earth point on the back plate. Measure in DC
Voltage, should be < 1 V.
32) Check the DC leakage between TP 7 (Z0VL) on the Power distribution board and
the cover on the Degass pump motor. Measure in DC Voltage, should be < 1 V
33) Check the DC leakage between TP 7 (Z0VL) on the Power distribution board and
the Degass pump head. Measure in DC Voltage, should be < 1 V.
34) Check the DC leakage between TP 7 (Z0VL) on the Power distribution board and
the cover on the Flow Out pump motor. Measure in DC Voltage, should be < 1 V.
35) Check the DC leakage between TP 7 (Z0VL) on the Power distribution board and
the Flow Out pump head. Measure in DC Voltage, should be < 1 V.
36) Check the DC leakage between TP 7 (Z0VL) on the Power distribution board and
the cover on the Flow In pump motor. Measure in DC Voltage, should be < 1 V.
reference instrument.
h) Press the Fluid bypass button to obtain main flow through the pressure
regulator.
i) Adjust the pressure regulator to +55 mmHg 5 mmHg. To get a correct
reading, the reference instrument and the test tube must be at same height
as the substitution fluid port.
j) Press the Fluid bypass button and remove the pressure reference
instrument and tube.
NOTE!
It is very important to do the following things (A, B and C) more or less
simultaneously i.e. within seconds.
3 Maintenance manual
A: Simulate blood in the priming detector.
B: Make sure (again) that the measuring glass is filled to 1.0 l.
C: Press the Start UF Stop button.
D: Press the flashing TMP button when UF rate is approximately at set value
(check bargraph).
Make sure that the blood pump is not stopped by any alarm during this test
since this may affect the accumulated UF volume. All kind of fluid alarms
(conductivity etc.) have to be avoided.
NOTE!
After the Capacity-test the machine has to be re-charged. After 24 h the back-up
batteries are fully re-charged.
If the machine stops within 15 minutes, re-connect the mains plug and the
backup-batteries must be exchanged. Before the machine turns off following
attention will be given.
3 Maintenance manual
41) Check that the overload protection on the heparin pump is working.
42) Check the arterial clamp by attaching the calibration tube set into the arterial
clamp. Enter priming mode and create a level detector alarm to get the clamp
closed. Apply a pressure of 600 mmHg. Check that the pressure does not fall
more than 30 mmHg in 15 seconds.
43) Check the venous clamp by attaching the calibration tube set into the venous
clamp. Enter priming mode and create a level detector alarm, by lowering the level
in the drip chamber, to get the clamp closed. Apply a pressure of 600 mmHg.
Check that the pressure does not fall more than 30 mmHg in 15 seconds.
44) Connect the mains plug to the outlet supply of an electrical safety tester.
Perform the Earth Leakage Test (ELT) and the Patient Earth Leakage Test (PLT)
according to instructions available in Electrical safety inspection for AK-machines.
45) Perform heat/chemical disinfection.
3 Maintenance manual
2) Change the pick-up tube B (blue-white).
inlet tube.
3.3.2.3 Actions to carry out after the parts have been exchanged
Procedure
1) First perform a heat disinfection program. Refer to the AK 200 S or
AK 200 ULTRA S Operators Manual.
NOTE!
If the pump segment has a different wall thickness, the occlusion of the pump
must be adjusted to the correct wall thickness.
Use the gauge pins (stop/go) available in the kit K40158001. The kit includes
following three different gauge pins:
3 Maintenance manual
T = 1.1 (Stop pin = 1.1x2x0.7 = 1.5mm)
T = 1.6 (Stop pin = 1.6x2x0.7 = 2.2mm)
T = 2.0 (Stop pin = 2.0x2x0.7 = 2.8mm)
T = wall thickness of the tubing
Use following formula to calculate which gauge pin to use:
2 x wall thickness x 0,7 (mm)
Adjustment instruction
Check the range between the pump rollers and the path according to the picture
below. Adjust range between the pump rollers and the path if it is necessary.
3 Maintenance manual
6) Change the (complete) venous pressure
line.
3.3.3.3 Actions to carry out after the parts have been exchanged
Procedure
1) Perform a heat disinfection program. Refer to the AK 200 S / AK 200 ULTRA S
Operators Manual.
2) Let the machine pass Fch with BiCart Select concentrate.
3 Maintenance manual
Earth Leakage Test (ELT) and Patient Leakage Test (PLT) according to Section 9
Electrical Safety Inspection on page189
Complete functional check.
NOTE!
If the fluid path has been opened for troubleshooting, a heat disinfection must be
performed before the machine is ready for next treatment.
4 Replacements
Perform actions according to instructions in the Maintenance manual.
Calibrate BiCart Select Control and Protective Pump
Calibrate according to calibration instructions in the Service Manual chapter
Calibration manual.
Calibrate BiCart Select Level Detector
Calibrate according to calibration instructions in the Service Manual chapter
Calibration manual.
Calibrate Blood Leak Detector
Calibrate according to calibration instructions in the Service Manual chapter
Calibration manual.
Calibrate Conductivity Cell A
Calibrate according to calibration instructions in the Service Manual chapter
Calibration manual.
Calibrate Conductivity Cell B
Calibrate according to calibration instructions in the Service Manual chapter
Calibration manual.
Calibrate FRN
Calibrate according to calibration instructions in the Service Manual chapter
Calibration manual.
Calibrate Internal Pressure Regulator (AK 200 ULTRA S)
Calibrate according to calibration instructions in the Service Manual chapter
Calibration manual.
Calibrate Level Detector (Air detector)
Calibrate according to calibration instructions in the Service Manual chapter
Calibration manual.
Heat Disinfection
Perform a heating according to the Operator's Manual.
I2C scan
Perform actions according to Service Manual chapter Maintenance support
description, Diagnostic Flow diagram, FM.
LED-test
Perform a LED test of the operators panel according to Service Manual, chapter
Maintenance Support Description, see Section 5.2.1 Available test procedures on
page89.
Load Preset file
Perform actions according to instructions in Service Manual chapter Maintenance
support description.
Occlusion
Calibrate according to calibration instructions in the Service Manual chapter
Calibration manual.
PET test
Perform the Protective Earth Test (PET) according to instructions available in
chapter Electrical safety inspection for AK-machines.
PLT test
Perform the Patient Earth Leakage Test (PLT) according to instructions available in
chapter Electrical safety inspection for AK-machines.
Set Time & Date
Set time and date according to instructions in the Service Manual, chapter
Maintenance support description.
4 Replacements
battery
Waste handling
Batteries from AK 200 S and AK 200 ULTRA S dialysis machines shall not be
discarded in normal waste, instead separate and proper collection systems must be
used. If improperly disposed, batteries might contaminate the environment and risk the
health of people.
NOTE!
Follow local legislation applicable for Battery and electronic waste handling.
NOTE!
For safety reasons, always order the new power supply cord from Gambro.
1) Press the selected parameter button. The actual information will be displayed on
the information display.
2) Set the value with the Set knob, (select set value or alarm limits by pressing the
appropriate Arrow button).
Is used to silence the buzzer. The buzzer will only be silenced for 30 seconds if the
alarm persists.
Is used for initiation and termination of treatment. It should normally not be pressed
during treatment.
5.1.4.1 Overview
The information display and the four buttons together with the Set knob, are used for
displaying and setting of all parameters except the blood flow. The blood flow is always
directly controlled with the Blood flow knob.
4) Use the Arrow buttons below Prev. and Next to navigate between LED groups.
5) The currently selected LED group will be lit, and its intensity value will be shown in
the time display.
6) Use the Set knob to adjust the light intensity of the currently selected LED group.
7) To exit the Panel Intensity menu, press the Hold button.
Bargraphs
With a dark display, keep the middle Arrow button (SET) depressed to light up the
display.
5.1.6.2 Backlight
There is a possibility to adjust a back light for the push-buttons on the front panel.
Press SET and then LOW push-buttons. When LOW button being pressed (keep it
pressed), the SET button can be released. After 3 seconds the display will lit up. Keep
the LOW button pressed and adjust the back light with the Set knob.
Second letter:
R: RAM variable
P: Process
F: Function
Third letter:
B: Byte (0-25)
I: Integer (whole numbers)
L: Logic (True / False)
R: Real (floating point numbers)
W: Word (0-65535)
Use the Set knob when you select arrays and press the Hold button when you want to
step backwards.
When it is necessary to look at two or three different arrays at the same time, use the
possibility to choose a separate field on the information display for each data.
To enter Service / Preset mode, press the Arrow button below ServPres and you will
be asked to set the service code:
Set the code with the Set knob (two digits for each button). If you do not press the
Arrow buttons within 30 seconds, restart from the first figure is required.
NOTE!
The remaining time must be set at 0.00 before the presetting can start.
5 Maintenance support description
Select the desired mode by pressing the Arrow button below this mode.
To exit from Service or Preset mode, press the Hold button below Fch.
AK 200 S / AK 200 ULTRA S dialysis machine will restart and perform a functional
check, Fch.
Select Preset.
NOTE!
All preset values and limits must be verified before treatment start.
Preset concentrates must be verified by laboratory test of the dialysate produced
by the AK 200 S / AK 200 ULTRA S dialysis machine.
Preset for pump segments must be verified by comparing the pumped volume
and a reference volume.
5.4.2 Configuration
Procedure
1) Choose the Arrow button below Config to select unit.
Config - Configuration
PC Pres - Preset with PC
2)
3) To configure the unit, turn Set knob and confirm by pressing the Arrow button
below REF SET.
5.4.3 PC Preset
In this mode it is possible to preset several hundred parameters and start up values
with help of a PC and the GXP - Gambro eXternal Preset -program.
This set up is used for customising (within certain limits) AK 200 S / AK 200 ULTRA S
dialysis machine. For more information, contact Gambro service.
5.4.4 Others
3) To select language, turn the Set knob. Select the button below REF SET. The
button will stop flashing and will then go out.
To set year/day of the week select the left Arrow button, to set month and day
select the middle Arrow button and to set hour and minute select the right Arrow
button. Turn the Set knob to change the value, press Arrow button to confirm.
3) To save changes and show the chosen time, press the Start UF Stop button.
3) Press the Start UF Stop button to store the preset. This confirms that the
AK 200 S / AK 200 ULTRA S dialysis machine consists of a BM 200 without pH
monitoring or other options (standard AK 200 S / AK 200 ULTRA S dialysis
machine).
5 Maintenance support description
The start up values for AK 200 S / AK 200 ULTRA S dialysis machines are set in the
same way as other presets. Following values can be preset by pressing appropriate
button:
SN/DN, SP/DP
Default: DN, SP
Volume control/Pressure control
Default: Volume control
Heparin
Volume (10.0 - 30.0 ml) and length (31.0 -119.0 mm) of syringe.
Default: volume 30.0 ml, length 81.0 mm.
Time (start up)
NOTE!
This variable is ignored if altitude preset, S550 is greater than 500 (m).
NOTE!
If the values are present as both concentrated and diluted concentrate, use the
concentrated values.
Procedure
1) When the Bicarbonate button is selected, following will be displayed:
Select Concentrate.
2) Select where to store concentrate (alt 2).
3) Select mmol/l.
6) Set cursor position at the digit which is going to be changed, with the Set knob. To
7) To confirm selected value and change cursor position, press Arrow button below
select pos. All values for the concentrate are set in this way.
8) When ready to continue with the next part in the concentrate, press Forw to
confirm the value, or step backwards by pressing Backw.
Turn the Set knob to change the character. Press the Arrow button below
selectchar.
11) Turn the set knob to change the cursor position. Press the Arrow button below
BiCart to change the selected character.
12) Press the Arrow button below Forw when the concentrate label is correct.
13) Press the Start UF Stop button to write preset parameters in EEPROM, or step
5 Maintenance support description
NOTE!
Preset concentrates must be verified by laboratory test of the dialysate produced
by theAK 200 S / AK 200 ULTRA Sdialysis machine.
WARNING!
Check that no disinfection solution has been taken in, if so a complete Chemical
rinse program must be performed.
NOTE!
The download from computer to machine (IT Expansion board) takes
approximately 10 seconds.
NOTE!
The transfer from IT Expansion board to dialysis machine, internally, will continue
and will take approximately 10 minutes in total. During this process boo will be
shown in the dialysis machines time display. When the process is ready the
dialysis machine will automatically restart and enter preset mode.
6.1.1 General
NOTE!
This chapter only describes AK 200 ULTRA S dialysis machine. Be aware of the
differences between AK 200 S and AK 200 ULTRA S dialysis machines and
therefore only use it as a reference!
The Gambro AK 200 ULTRA S System is intended for use as a single patient machine
to perform hemodialysis (HD), hemodiafiltration (HDF) and hemofiltration (HF).
The System is also intended for on-line preparation of substitution fluids (see below) to
be used in HDF and HF.
The AK 200 ULTRA S System comprises of two monitors; one blood monitor (BM 202)
and one fluid monitor (FM 202). The monitors are placed on a mobile stand (MS 200 or
MS 202). The blood monitor is designed to control and supervise the extracorporeal
blood circuit. Single needle treatment can in hemodialysis be performed with one
pump (double clamp function) or with two pumps. To prevent coagulation, heparin may
be administered by means of a heparin pump. Single needle treatment can be carried
out with one or two blood pumps. Double needle treatment is carried out with only one
blood pump. Hemofiltration or hemodiafiltration is only carried out in double needle
treatment. The second pump is acting as substitution pump in these modes.
Disposable lines are used for the blood and the substitution flow.
The fluid monitor is designed to produce the dialysis and substitution fluid at a desired
temperature, conductivity and pressure within given specifications. It shall supervise
the fluid and transport the fluid through the dialyzer. The fluid monitor maintains the
dialysis flow through the dialyzer/filter with controlled ultrafiltration or controlled TMP1.
When a fault occurs, the fluid monitor bypasses the dialyzer. The monitor also detects
1 TMP is defined as the difference Pb out - P d out + 18.4 mmHg, where Pb out is the venous drip chamber
pressure and Pd out is the pressure measured in the dialysis fluid where it enters the machine after the
dialyzer. The offset of 18.4 mmHg compensates for the vertical distance between the pressure sensors.
6 Technical description
performed.
The on-line production of substitution solution can be deactivated and the
AK 200 ULTRA S dialysis machine can be used for HDF with bags.
The dialysis fluid consists of water and concentrate. The fluid monitor operates either
in acetate or bicarbonate mode. In bicarbonate mode the monitor mixes dialysis fluid
from water and two concentrates: acid and bicarbonate. The mode is selected from the
operators panel.
When AK 200 ULTRA S dialysis machine is used to produce bicarbonate containing
dialysis fluid originating from non-liquid concentrates, it is designed and validated for
use with the BiCart system.
When AK 200 ULTRA S dialysis machine is used to produce sodium chloride
containing dialysis fluid originating from non-liquid concentrates, it is designed and
validated for use with the BiCart Select system, i.e. the SelectCart cartridge and
SelectBag concentrate.
The fluid monitor should be disinfected after every treatment. The AK 200 ULTRA S
dialysis machine is disinfected according to the Operators Manual, with either
chemical disinfectants or with heat disinfection.
The fluid monitor also includes a power supply and a heat exchanger.
The MS 200 includes pressure regulator, infusion stand, a double filter holder for two
ultrafilters and a bottom tray.
The system is operated from the operators panel located on the blood monitor. For
information about the use and function of the operators panel, see chapter
Maintenance support description, or the AK 200 ULTRA S Operators Manual.
6.1.2.1 Overview
The AK 200 ULTRA S dialysis machine includes the following main functions.
6.1.2.5 Options
pH 200 K18266001
Battery Backup K18614001 (24V)
Electrically adjustable stand, MS 200
6.1.2.6 Others
Automatic Power On Test
External Logging via PC, GXL
Presetting of system parameters (internal or via external PC)
Download of new software via PC, GXD
6.1.3 Parameters
System and treatment parameters can be set at five different levels (Table1).
Level Type of parameters Presetable by:
4 Treatment parameters Operator, nurse
3 Alarm limits and defaults Clinic's technician
2 New functions Gambro technician or Gambro
subsidiary
1 Adaptions Gambro Head office
0 Safety limits Fixed
For information about setting the parameters in level 2 and 3, see Section 5
Maintenance support description on page78.
For information about the use and functions of the parameters in level 4, see the
AK 200 ULTRA S Operators Manual.
6 Technical description
6.2.1 Fluid Monitor
6 Technical description
6.2.3.1 Water intake
Feed water passes via a pressure regulator, an inlet valve, a heat exchanger and an
ultra filter to a heating vessel. The ultra filter is continuously flushed with a certain flow,
approx. 50-100 ml/min. that goes directly to drain via a restrictor.
The feed water must fulfil the ASAIO and AAMI standards on feed water for dialysis
monitors. The pressure regulator reduces pressure to a maximum of 1 bar.
The temperature of the incoming water is raised a couple of degrees in the heat
exchanger. This reduces the power consumption of the heating elements.
The inlet valve (INVA) is normally open. The water level in the heating vessel is
regulated by means of a float valve in the bottom of the heating vessel. The float valve
is closed when the water level reaches maximum and is opened when it falls to
minimum. The flushing valve (FLVA), which is used during disinfection, is closed during
treatment.
A non-return valve, placed between the recirculation loop, in front of the return flush
valve (RFVA) and behind the inlet water valve (INVA) is used to enable disinfection of
the first ultra filter.
The temperature transducer in the heating vessel measures the water temperature
and controls the heating. The heating vessel has two heaters and a stirrer. The stirrer
is used to ensure a constant water temperature.
From the heating vessel the feed water passes via a filter and a restrictor to an
expansion chamber. The function of the restrictor is to produce the negative pressure
that is necessary for degassing the fluid. The bubbles are separated in the degassing
chamber. The recirculation is controlled by a stepping motor. The degassing restrictor
bypass valve (DRVA), which is used during disinfection, is closed during treatment.
Constant pressure in the expansion chamber and constant level in the degassing
chamber are maintained by means of the degassing pump and the recirculation valve.
6.2.3.2 Concentrate
The dialysis fluid is a mixture of water and acetate based concentrate. (Salt is added to
the water in order to prevent the essential salts in the blood from passing through the
membrane in the dialyzer into the dialysis fluid). Water and concentrate are mixed in
the expansion chamber.
The amount of concentrate is regulated by the feed pump (piston pump). The amount
of concentrate to be added is determined by measuring the conductivity of the fluid.
Conductivity is the ability of the fluid to conduct electricity. (The conductivity cell is used
to measure the conductivity of the fluid.) The conductivity depends on the dialysis fluid
temperature (approx. 1.8% per C). The temperature transducer in the conductivity cell
is used to measure the temperature of the fluid and as certain the correct conductivity
value (to compensate for temperature fluctuations).
If conductivity is outside the preset limits, the dialyzer is bypassed and the dialysis fluid
goes directly to the drain (the direct valve - DIVA - is closed and the bypass valve -
BYVA - is opened). This situation may arise if there is not sufficient concentrate, the
concentrate pick-up tube is not properly inserted in the concentrate container, the flow
through the tube is obstructed or the water supply is insufficient. The proportioning
bypass valve - PBVA - is closed during treatment. The PBVA is open during
disinfection. The reason for this is that there is an under pressure after the feeding
pump. When the fluid monitor is disinfected, the system can be quickly filled with
disinfectant if the PBVA is open.
The FM can operate in either acetate mode or bicarbonate mode (selectable by the
operator). The concentrate (acetate) is fed in via the Binlet.
In bicarbonate mode two concentrates are used, referred to as A- and B-concentrates.
First the A-concentrate is mixed with water in the mixing chamber. The fluid then
passes to the expansion chamber, where the B-concentrate is added. The amounts of
concentrate are regulated with two feed pumps (piston pumps). The conductivity is
measured by means of two cells. The conductivity cell in unit 1 measures the
conductivity at the first stage. The second cell measures conductivity after the B
component has been added.
6 Technical description
chamber). The flow pump is also used to regulate the fluid level in the degassing
chamber. The level is monitored by a level detector.
It is very important that the dialysis fluid should have the correct conductivity. It is very
important that the system is able to detect if an incorrect concentrate is being used.
The pH sensor (optional) is used as an improved safeguard against faulty and/or
incorrect concentrates. (There is some disinfection solutions that can give correct
conductivity. But these solutions do normally not have the correct pH value.) If the
concentrate pick-up tubes are incorrectly inserted, this will also produce an incorrect
pH value.
After the pH-sensor there is a flow reducer and a bypass valve (FOVA). The function of
the flow reducer is to create a negative pressure.
The main flow is variable between 300 and 700 ml/min.
The bypass valve FOVA (closed during treatment) is used in disinfection mode. The
flow through the dialyzer is controlled by means of two pumps: flow output pump and
flow input pump (gear-wheel pumps). The function of the pumps is to maintain a
constant flow, to and from the dialyzer.
Treatment can be either volume controlled (UF) or pressure controlled (TMP). The
mode is selected from the operators panel.
In both UF and TMP mode, a variable main flow (300 - 700 ml/min) to the dialyzer is
obtained by means of the flow output pump. The pressure over the flow reducer is
adjustable, and thereby, a variable main flow is obtained.
Constant flow after the dialyzer is obtained by means of the flow-input pump. The input
flow is normally higher than the output flow. Dialysis patients are water retentive and
the excess is removed during treatment. The UF rate is a measure of the quantity
removed. If the output flow is 500 ml/min, the input flow may, for example, be 502
ml/min. In UF mode, the differential flow from the UF measuring cell and the required
UF rate (selected by the operator) is used to regulate the flow input pump so that the
desired pressure is obtained. After the flow input pump there is a positive pressure.
In TMP mode, TMP is used to regulate the flow input pump. The UF measuring cell is
used to measure the UF rate, but the measuring cell is not involved in the regulation of
the flow input pump.
Every 30 minutes during treatment, the UF measuring cell is automatically calibrated to
ensure correct performance. (This has to be done because waste products in the fluid
returned from the patient may be deposited in layers on the inside of the measuring
channels.) The calibration can be divided into three phases. During phase 1 the UF
measuring system is calibrated. During phase 2 the UF measuring unit and the
dialyzer are bypassed, i.e. there is no fluid passing through neither of the two channels
(DIVA, TAVA, and BYVA valves are closed and ZEVA valve is open). Thus the offset of
the two measurement channels can be measured.
Finally during phase 3 the dialysis fluid bypasses dialyzer but passes through the UF
measuring unit, i.e. the same amount of fluid is passing through both channels of the
UF measuring cell (DIVA, TAVA, and ZEVA valves are closed and BYVA valve is
open).
With channel 1 as a reference, channel 2 can be calibrated. The UF rate is now zero.
Calibration takes totally about 60 - 90 seconds. Treatment is then resumed.
After the UF measuring cell there is a pressure transducer (high-pressure guard) which
is activated if the pressure before the dialyzer becomes too high. For example, if there
is a blockage somewhere in the tubes, the high pressure guard is activated, the flow is
stopped and the system goes into bypass mode (see below).
and bypass valve (BYVA). The direct valve is normally open during treatment (if the
temperature, pressure, conductivity etc. are within the predefined limits). In an
emergency situation (e.g. in the event of a blood leak being detected), the direct valve
is closed and the bypass valve is opened. The dialysis fluid is led past the dialyzer
directly to the drain. The following situations result in a bypass:
Blood leak detected
Temperature out of limits
Conductivity out of limits
pH alarm (optional)
Technical error message
From the direct valve (DIVA) the dialysis fluid is forwarded to a second ultra filter and
further on through an infusion-outlet-port, a pressure regulator and the clean water
valve (CWVA).
The infusion line set is connected to the infusion outlet-port to access the infusion
solution.
The solution is forwarded to a single use filter. The integrity of this sterile filter has
been tested (for every filter) during manufacturing.
The pressure regulator is used to always maintain a positive fluid pressure (approx.
+50 mmHg) to ensure that the infusion line segment does not collapse during
operation.
The filter valve (FIVA), closed during treatment, is used for disinfection of the second
ultrafilter.
From the clean water valve (CWVA) the dialysis fluid is passed on to the dialyzer or in
bypass mode to drain.
In hemofiltration mode (HF mode) the clean water valve (CWVA) is always in bypass
mode but for hemodialysis mode (HD mode) or hemodiafiltration mode (HDF mode) it
may operate in both modes. The dialysis fluid is forwarded to the dialyzer via the
output tube.
From the dialyzer the dialysis fluid (mixed with waste products) is returned to the fluid
monitor via the input tube. The input tube nipple is fitted with a filter.
The taration valve (TAVA) is normally open. During the UF measuring cell calibration,
the taration valve is closed.
The zero setting valve (ZEVA) is normally closed. During the UF measuring cell
calibration phase 2, the zero setting valve is open.
The pressure transducer, Pd, measures the dialysis fluid pressure. The measurement
is used in the calculation of the TMP. The pressure transducer also activates an alarm
if the pressure becomes too high.
The dialysis fluid is fed to the bubble trap. The function of the bubble trap is to
separate air from the fluid. For example, a leakage may occur in the dialyzer. When
the fluid level in the bubble trap reaches the minimum level, i.e. when there is too
much air in the vessel, the evacuation valve (EVVA) is opened and the air is released.
The fluid level is monitored with a level detector.
The blood leak detector detects any blood in the dialysis fluid. In the event of the
slightest leak between the blood side and dialysis fluid side of the dialyzer, an alarm
will be activated. If blood is detected, the system goes into bypass mode. The
emptying valve (EMVA), which is closed during treatment, is used to empty the blood
leak detector when treatment is completed.
6 Technical description
6.2.4 Design and Construction
Following section describes the sub-units, the valves and the electrical boards used in
the fluid monitor.
The fluid monitor contains three pump units. Each pump unit includes the
following:
Gear wheel pump.
Pressure transducer with board.
The pressure transducer is connected to the transducer board, via a twisted
cable. The transducer board interfaces directly to the distribution board, via a
board connector.
Output restrictor bypass valve, FOVA (flow output pump), evacuation valve,
EVVA (flow input pump), DRVA (degassing pump).
4. Pump Unit 2 (flow out)
see above
5. Pump Unit 1 (degassing)
see above
6. Particle Filter
7. Degassing Chamber
Both the degassing chamber and the deairating chamber have the function to
separate air from the dialysis fluid. Each degassing- and deairating chamber
contains a level detector.
8. Heating Vessel Unit
The heating vessel unit contains the following:
Heating vessel.
2 heating rods with over heating guard.
Temperature transducer (PT 100) with temperature transducer board. The PT
100 transducer is connected to the transducer board, via a twisted cable. The
transducer board interfaces directly to the FM Analog Distribution board, via a
board connector.
Float valve.
Water level guard.
Stirrer with 12 V DC-motor.
2 pick-up tube detectors.
9. Bypass Unit
The bypass unit includes the following:
Direct valve - DIVA.
Bypass valve - BYVA.
High Pressure Guard
The high-pressure guard is a pressure transducer with a board. The pressure
transducer is connected to the transducer board, via a twisted cable. The
transducer board interfaces directly to the distribution board via a board connector.
10. Concentrate pick-up tube connections
11. High Pressure Guard
12. UF Measuring Unit
The UF measuring unit consists of a measuring cell and two printed circuit boards.
They are mounted on each side of the measuring cell. The UF measuring unit
interfaces directly to the main board, via a flat cable.
6 Technical description
Both the degassing chamber and the deairating chamber have the function to
separate air from the dialysis fluid. Each degassing- and deairating chamber
contains a level detector. The deairating chamber also contains a pressure
transducer. The pressure transducer is used to measure the dialysis fluid pressure.
The pressure transducer is connected to the transducer board, via a twisted cable.
The transducer board interfaces directly to the distribution board, via a board
connector.
14. Safety Bypass Unit
The safety bypass unit includes the following: Safety pressure transducer with
board. The pressure transducer is connected to the transducer board, via a twisted
cable. The transducer board interfaces directly to the distribution board, via a
board connector.
15. Infusion Port
16. Diascan
With the use of a conductivity sensor, placed after the dialyzer in the fluid path, it is
possible to measure clearance during treatment. The used method for estimation
of urea clearance has been verified by urea clearance derived from blood samples
during dialysis and has proved to provide comparable accuracy.
1. Conductivity Cells
2. Level Detector
3. Control Pump
4. Protective Pump
5. Feeding Pump A
The fluid monitor contains two feeding pumps. Each pump unit consists of a piston
pump driven by a stepping motor.
6. Feeding Pump B
The fluid monitor contains two feeding pumps. Each pump unit consists of a piston
pump driven by a stepping motor.
7. Mixing Chamber
Water and concentrate are mixed in the mixing chamber.
8. Top Priming Chamber
9. Heat exchanger
The temperature of the incoming water is raised a couple of degrees in the heat
exchanger. This reduces the power consumption of the heating elements. The
heat exchanger is located on the back plate of the AK 200 ULTRA S dialysis
machine.
10. Reducer Unit
11. Air Collect Chamber
6 Technical description
In hemofiltration mode (HF mode) the clean water valve (CWVA) is always in bypass
mode but for hemodialysis mode (HD mode) or hemodiafiltration mode (HDF mode) it
may operate in both modes. The dialysis fluid is forwarded to the dialyzer via the
output tube.
DIVA - Direct Valve
Normally open during treatment. Closes in alarm situations. Closed during UF-cell
self-calibration.
DRVA - Degass Resctriction Valve
Open during heat disinfection to prevent the fluid system from boiling by bypassing the
degassing restrictor.
EMVA - Emptying Valve
Three-way valve. Used to facilitate the emptying the blood leak detector.
EVVA - Evacuation Valve
Special three-way valve, only one of the house halves has a seat. From the functional
point of view it works like an ordinary open/close valve. Opens when the level in the
deairating chamber drops below its low limit to let out air from the chamber.
FIVA - Filter Valve
The filter valve (FIVA), closed during treatment, is used for disinfection of the second
ultrafilter.
FLVA - Flush Valve
Open during disinfection for flushing the upper part of the heating vessel.
FOVA - Flow Output bypass Valve
Open during heat disinfection to prevent the fluid system from boiling by bypassing the
flow out restrictor.
HDVA - HD/HDF Valve
INVA - Inlet Valve
The inlet valve is normally open to let water into the heating vessel. It is closed in
following situations:
1. If the water level in the heating vessel is too high.
2. In disinfection mode (except when the system is flushed).
LDVA - Level Detector Valve
The level detector is used in the protective system for supervision of the SelectBag
concentrate flow.
PAVA - Priming A Valve
Open during the priming of the SelectCart and the BiCart cartridges.
PBVA- Proportion Bypass Valve
Open in chemical disinfection when filling up. Opens during BiCart priming.
Recirculation Valve
Proportional valve (three-way valve) controlled by stepper motor. Part of the degassing
level regulation.
RFVA- Return Flush Valve
6.2.6.1 Wiring
For a detailed description how to connect all cables in AK 200 ULTRA S dialysis
machine, see Section 10 Wiring diagram on page199:
Wiring Diagram FM 200 S, K20583
Wiring Diagram BM 200 S, K20595
Following is a brief functional description of each board in the fluid monitor.
6 Technical description
supervision pump synchronization detectors, supervision level detector, SelectCart
cartridge latch status detector and SelectBag container position detector. Output
signals to control and supervision pumps, supervision level detector and valves.
Power: +5 V and +24 V.
P7 is a 4 pin connector connected to the I2C-EEPROM at the run time meter. Signals:
CAD0 and CAC0. Power: +5 V.
P8 is a 2 pin power connector connected to the Power Distribution Board FM. +24 V is
supplied in this connector.
P9 is a 20 pin connector connected to the Power Distribution Board FM. Input signals
from an external RS232 interface and from the Blood Pressure Monitor, BPM. Output
signals to the external RS232 interface, to the BPM and to the FM fan. Bi-directional
signals are the Echelon bus signals CEDA, CEDB, PEDA and PEDB and SBSI that
connects the safe bus between FM and BM. Power: +5 V.
P10 is a 10 pin expansion connector for the protective Echelon bus. Signals: PEDA
and PEDB. Power: +5, +12 and -12 V.
P11 is a 10 pin expansion connector for the control Echelon bus. Signals: CEDA and
CEDB. Power: +5, +12 and -12 V.
P12 is a 4 pin optional I/O connector. TIN1 and TIN2 are input signals. Power: +5V.
P13 is a 10 pin analog test connector used in production. Five analog signals are
connected to this connector.
P14 is a 2 pin connector connected to the deairating ultrasonic level transducer.
P15 is a 2 pin connector connected to the degas ultrasonic level transducer.
P16 is a 4 pin optional +24 V output connector.
P17 is a 20 pin connector for protective node Q used for emulation. The reset and the
service pin of the neuron chip are connected to P17 together with the 11 I/O pins.
Power: +5 V.
P18 is a 20 pin JTAG test connector. Signals are the five JTAG test signals connected
to the FPGA and 8 further signals that can be used for test of the FPGA. Power: +5V.
P19 is a 20 pin connector for the Select supervision node used for emulation. The
reset and the service pin of the neuron chip are connected to P19 together with the 11
I/O pins. Power: +5 V.
P20 is a 20 pin connector for the control communication node used for emulation. The
reset and the service pin of the neuron chip are connected to P20 together with the 11
I/O pins. Power: +5 V.
P21 is a 20 pin connector for the protective flow restrictor node used for emulation.
The reset and the service pin of the neuron chip are connected to P21 together with
the 11 I/O pins. Power: +5 V.
P22 is a 20 pin connector for the Select control node used for emulation. The reset
and the service pin of the neuron chip are connected to P22 together with the 11 I/O
pins. Power: +5 V.
6 Technical description
This board is localized in the AK 200 ULTRA S fluid monitor, where its function is to
gather all the sensor signals to one cable that is connected to the main FM CPU
board. The devices that are connected on this board are:
Conductivity cells
All fluid pressure sensors
Blood leak detector
Temperature sensors
Dia connector sensors
Return flow valve RFVA
Feeding Pumps
Conductivity Measuring Unit
Water Inlet Unit
Top Priming Unit
The distribution board contains 13 board connectors, which are used to interface the
transducer boards. Three of the connectors are normally not used. The
temperature/pressure transducer and the transducer board must not be separated. If
the transducer is to be replaced, the transducer board must also be replaced (and vice
versa). It is important that the transducer boards are connected to the correct
distribution board connector. For example, board connector P22 must not be used for
any other transducer board than the dialysis fluid pressure transducer board.
6 Technical description
6.3.2.1 Double Needle Treatment - HD
Following figure illustrates the flow diagram when the AK 200 ULTRA S dialysis
machine is used for double needle treatment.
is too low or too high, the blood flow is stopped (the blood and heparin pumps are
stopped and the line clamps are closed). Too high venous pressure may be caused by
an obstruction after the venous drip chamber or a change in the patients position. If
the venous pressure is too low, it could be caused by a line separation, an obstruction
before the venous drip chamber, a fall in blood pressure or a change in the patients
position.
The priming detector detects if there is blood in the venous blood line.
The blood is returned to the patient via the venous line clamp. The clamp is normally
open. But in the event of an alarm from the air detector, the venous pressure
transducer or the blood leak detector (in the fluid monitor), the line clamp clamps the
blood line and stops the blood flow.
Figure 6-2. Simplified Flow Diagrams - Single Needle Treatment - Single Pump
When the AK 200 ULTRA S dialysis machine is used for single needle-single pump
treatment, the arterial and venous phases are time- or pressure controlled.
Arterial blood is removed from the patient when the arterial line clamp is open and the
venous line clamp is closed. The running time of the arterial blood pump is determined
by the operator. In this way a positive pressure is created. In the next phase, the blood
pump is stopped, the arterial line clamp is closed and the venous line clamp is opened,
i.e. the blood is returned to the patient by means of the positive pressure.
The venous line clamp is then closed, the arterial line clamp is opened, the blood
pump is started and the procedure repeated. In single needle mode, the operator
defines the length of time the arterial and venous line clamps are to be open and
closed.
The expansion chamber evens out pressure pulsation. The blood level in the
expansion chamber is electrically adjustable from front panel.
6 Technical description
Figure 6-3. Simplified Flow Diagrams - Single Needle Treatment - Double Pump
When the blood monitor is used for single needle treatment, both blood pumps are
used. Note that the pumps are running in divergent directions.
The treatment is controlled by a predefined stroke volume, mean blood flow and by the
high limit on the system pressure transducer (extra).
The required mean blood flow and stroke volume is determined by the operator. When
the mean blood flow is affected, the venous and arterial blood pump will change its
speed. The venous pump is volume controlled.
The mean blood flow is set in the same way as the required blood flow in the double
needle treatment. When the SN button is pressed, the arterial blood pump will start
and will run until the expansion chamber is filled up (detected by the high limit on the
system pressure transducer). The venous blood pump then will start, and will run until
the predefined stroke volume has been returned to the patient. This is monitored by
the low limit on the system pressure transducer after the filter. The process is repeated
throughout treatment.
Since the two blood pumps run alternately, the drip chamber acts as an expansion
chamber to even out pressure pulsation.
The standard configuration includes three pressure transducers: arterial pressure
transducer, venous pressure transducer and system pressure transducer.
Figure 6-4. Simplified Flow Diagram - Double Needle treatment - post dilution
Figure 6-5. Simplified Flow Diagram - Double Needle treatment - pre dilution
NOTE!
This mode can only be used if the AK 200 ULTRA S dialysis machine is used in an
non-online mode. See AK 200 ULTRA S Operators Manual for further information.
6 Technical description
port on the FM, pumping it through an ultrafilter, into either the venous line
(post-dilution), or the arterial line (pre-dilution).
See AK 200 ULTRA S Operators manual for further information.
6.3.2.3.4 HF on line
When AK 200 ULTRA S dialysis machine works in HF on-line mode, the setup for the
lines are the same as for HDF, either pre- or post dilution can be used.
See AK 200 ULTRA S Operators manual for further information.
6.3.3.2 Batteries
A 9-volt battery, used to drive buzzer alarm during mains power failure, is mounted
inside the blood monitor. The battery is connected after installation.
A lithium battery, mounted on the main board, is used to run the real time clock in BM
202.
WARNING!
Lithium battery - danger of explosion! When replacing the battery, use the same type
(recommended by Gambro service representative).
Two different drip chamber levels can be adjusted. The level in the venous drip
chamber is electrical adjusted by pressing the level adjustment buttons on the front
panel.
The level in the venous drip chamber is adjusted by pressing or in the right (blue)
area.
The level in the expansion chamber connected to the system pressure transducer
connector may be adjusted by pressing or in the left (gray) area.
6.3.3.6 Fan
The drive motor (24 V DC-motor) and the fan form a single unit.
6 Technical description
device.
The BM 202 is equipped with a second pressure transducer after the filter, named
System Pressure Transducer. This pressure will only be displayed if the SN data
button is depressed. The transducer is mounted on a transducer board, which also
interfaces directly to the BM Analog Distribution board, via a board connector.
The BM 202 is equipped with a third pressure transducer, named Arterial Pressure
Transducer. This pressure will be displayed on the arterial bargraph. The transducer is
used for true arterial pressure measurement or any other pressure. The pressure
transducer is mounted on a pressure transducer board, which interfaces to the BM
Analog Distribution board, via a board connector.
peaking. The heart rate is determined by using the pressure oscillations measured by
the pressure transducer.
When to measure the diastolic pressure is determined by extensive experiments to
establish an algorithm, which is included in the BPM software.
In the field it is possible to perform a check of the device to determine if it works or not.
The device has to be sent to Gambro for repair incase of malfunction.
6.3.4.1 Wiring
For a detailed description how to connect all cables in AK 200 ULTRA S dialysis
machine, see the attached drawing:
Wiring Diagram FM 200 S, K20583
Wiring Diagram BM 200 S, K20595
Following is a brief functional description of each board in the blood monitor.
6 Technical description
open No termination
J3, Reset
1-2 Reset
open Normal, reset only possible with IC2 or through
command on the echelon bus
6 Technical description
P69 Motor BPV Motor output for venous blood
pump
P70 Test Contr. Comm. Test connector for control
communication
P71 24 V Supply Input for 24 V DC supply
voltage
P72 FM Power dist. Input and outputs towards
power distribution board
P73 Back light Supply voltage for back light
inverter on display
P74 Level adjustment Input for level adjustment keys
P75 LVDS LVDS output interface for
display
P76 Parallel interface Parallel interface from
protective FPGA
All leakage currents are specified without external equipment connected to the
machine.
Mains voltage is fed to an AC/DC converter. The AC/DC converter supplies the DC/DC
units in the fluid monitor and in the blood monitor respectively with supply voltage (+24
V).
A mains transformer and a stabilizer provide the power control logic in the blood
monitor with necessary supply voltage (+12 V).
The power supply also supplies the heater rods in the fluid monitor with their supply
voltage (mains). If the power supply is of 115 V type, the heater rods must be supplied
from the mains directly. Consequently, in this case two mains cables are required: one
is connected between the power unit and the power supply and one is connected
between the power unit and the fluid monitor.
In a mains power failure situation, the AK 200 S / AK 200 ULTRA S dialysis machine
gives an intermittent buzzer alarm and is disconnected from the +24 V supply by
means of signal REMO. Signal REMO is obtained from the power control logic in the
blood monitor.
7.4 Materials in contact with water, concentrates and dialysis fluid ......................... 167
7.4.1 Polymers................................................................................................................ 167
7.4.2 Metals .................................................................................................................... 167
7.4.3 Others.................................................................................................................... 167
7.1.1 Notes
NOTE!
7.1.11 Diascan
Accuracy is valid in HD mode double needle treatment, for blood flows 200 to 500
ml/min and fluid flows 500 to 700 ml/min, UF profiling is allowed.
Clearance, K 0 to 350 ml/min (10 %)
Cumulated water volume cleared of urea, Kt 0 to 100 l (10 %)
Dialysis dose, Kt/V 0 to 3 (10 %)
Plasma sodium, Na+ 130 to 160 mmol/l
Table 7-18. Heat disinfection Program with CleanCart cartridge including WRO 300 H
Decalcification CleanCart C
Cleaning CleanCart A
Temperature 93 C
Fill up phase 10 minutes
(13 minutes with UFD-kit (optional))
Circulation phase 15 minutes
Low flow heat phase 20 minutes
Rinse/Drain phase 4 minutes
(11 minutes with UFD-kit (optional))
Total time 49 minutes
(59 minutes with UFD-kit (optional))
7.1.14 Drain
Drain (length of tube) Maximum 5 m
Drain capacity Minimum 1.0 l/min
Drain outlet Maximum 1.2 m above floor
If the optional air-gap on the machine is used the distance between the air-gap and the
drain must not be less than 0.3 m. For an electrically adjustable stand in its lowest
position this means that the drain must not be higher than 580 mm. For a mechanically
adjustable stand in its lowest position the drain must not be higher than 550 mm.
All leakage currents are specified without external equipment connected to the
machine.
Alarm limits are temporarily extended to 10 %. Maximum mean deviation for a 5 hour
treatment is 0.2 mS/cm.
7.2.7 Ultrafiltration
Dialysis fluid flow operating range 300 - 700 ml/min
UF rate supervision -4.0 to +4.0 l/h (2 ml/min). Accuracy 5
ml/min verified at start-up.
UF rate supervision, max allowed difference 1-10 ml/min, ( 5 ml/min)
between control and protective system, can be
preset (Default)
Accumulated UF volume alarm limit (Default) 200 ml, or 70 - 130 ml/h ( 130 ml/h) *
passed treatment time (h), whichever is
greatest.
Treatment Time Control 0.05 to 9.59 hour.minute (1 minute)
TMP supervision alarm -200 to +550 mmHg (15 mmHg) For
AK 200 S dialysis machine, TMP is defined as
Pb out -Pd out + Offset, where Pb out is the
venous drip chamber pressure and Pd out is
the pressure measured in the dialysis fluid,
where it enters the machine after the dialyzer.
The offset compensates for the vertical
distance between the pressure sensors.
7.4.1 Polymers
Silicon rubber
Santroprene
PVC (Polyvinylchloride)
PEEK (Polyetherketone)
PEX (Polyethylene)
PP (Polypropylene)
PP (Polypropylene reinforced with talcum)
PSU (Polysulphone)
PVDF (Polyvinylidene fluoride)
PTFE (Polytetrafluoro ethylene)
Parylene C
7.4.2 Metals
Stainless steel SS2343
Stainless steel SS2353
Stainless steel SS2562
Titanium
Platinum
7.4.3 Others
Carbon
Ceramic, Steatite 221
Ceramic, Aluminum oxide (Al2O3)
Ceramic, Zirconium oxide (ZrO2)
Glass
Barium Ferrite
7.5.1 Operation
If condensation occur when moving the equipment between locations with different
7 Technical data and specifications -
temperatures and high relative humidity (e.g. outdoor and indoor locations), the inside
of the equipment shall be allowed to dry before switching on the equipment.
AK 200 S dialysis machine
7.5.3 Energy
Typical energy consumption for a 4 hour treatment with inlet water temperature of 5 C
and 500 ml/h main flow is 2.7 kWh. Energy delivery to the environment is
approximately 400 Wh independent of inlet water temperature.
Energy delivery to the drain during a 4 hour treatment is 2.3 kWh.
The temperature at the drain can be up to 80 C.
Power consumption and delivery to the drain decrease with approximately 19 W for
every degree increase of inlet water temperature.
80 MHz to 800
aField strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile
radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To
assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the AK 200 S dialysis machine is used exceeds the
applicable RF compliance level above, the AK 200 S dialysis machine should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the
AK 200 S dialysis machine.
bOver the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
NOTE!
At 80 MHz and 800 MHz, the higher frequency range applies.
These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
2W - - 0.33
GSM/3G
For transmitters rated at a maximum output power not listed above, the recommended separation distance d
in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is
the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE!
At 80 MHz and 800 MHz, the separation distance for the higher frequency range
applies.
These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
7.6 Standards
The machine complies with the following standards:
IEC 60601-1 General requirements for safety, Class I, type B
IEC 60601-2-16 Particular requirements for safety of haemodialysis, haemodiafiltration
and haemofiltration equipment
IEC 60601-2-30 Particular requirements for the safety of automatic cycling indirect
blood pressure monitoring equipment
IEC 60601-1-2 Electromagnetic compatibility
EN 1060-1 Non-invasive sphygmomanometers Part 1: General requirements
EN 1060-3 Non-invasive sphygmomanometers Part 3: Supplementary requirements
for electromechanical blood pressure measuring systems
NFS 90-304 Medico-surgical equipment Hemodialysis equipment
8.4 Materials in contact with water, concentrates and dialysis fluid ......................... 184
8.4.1 Polymers................................................................................................................ 184
8.4.2 Metals .................................................................................................................... 184
8.4.3 Others.................................................................................................................... 184
8.1.1 Notes
NOTE!
When accuracy ranges are written as e.g. (1ml/min or 1 %) the widest
range is valid.
For the qualified technician, the Service Manual for the AK 200 ULTRA S
dialysis machine is available. The Service Manual provides all the necessary
information for the safe and required maintenance of the machine.
8.1.11 Profiling
UF-rate 0 to 4 l/h
Na+, Acetate mode 115 to 160 mmol/l
Na+, Bicarbonate mode 130 to 150 mmol/l
HCO3-, Bicarbonate mode 20 to 40 mmol/l
8.1.12 Diascan
Accuracy is valid in HD mode double needle treatment and on-line HDF mode double
needle treatment, for blood flows 200 to 500 ml/min and fluid flows 500 to 700 ml/min,
UF profiling is allowed.
Clearance, K 0 to 350 ml/min (10 %)
Cumulated water volume cleared of urea, Kt 0 to 100 l (10 %)
Dialysis dose, Kt/V 0 to 3 (10 %)
Plasma sodium, Na+ 130 to 160 mmol/l
8.1.15 Drain
Drain (length of tube) Maximum 5 m
Drain capacity Minimum 1.0 l/min
Drain outlet Maximum 1.2 m above floor
If the optional air-gap on the machine is used the distance between the air-gap and the
drain must not be less than 0.3 m. For an electrically adjustable stand in its lowest
position this means that the drain must not be higher than 580 mm. For a mechanically
adjustable stand in its lowest position the drain must not be higher than 550 mm.
All leakage currents are specified without external equipment connected to the
machine.
respective IEC or ISO standards (e.g. IEC 60950 for data processing equipment).
Furthermore all configurations shall comply with the requirements for medical electrical
systems (see IEC 6060111 or clause 16 of the 3Ed. of IEC 606011, respectively).
Anybody connecting additional equipment to medical electrical equipment configures a
medical system and is therefore responsible that the system complies with the
requirements for medical electrical systems. Attention is drawn to the fact that local
laws take priority over the above mentioned requirements. If in doubt, consult your
local representative or the technical service department. Use of other cables may
result in increased emissions or decreased immunity for the equipment or system.
Protective caps shall be attached when the connectors are not in use.
Alarm limits are temporarily extended to 10 %. Maximum mean deviation for a 5 hour
treatment is 0.2 mS/cm.
8.2.7 Ultrafiltration
References
Assembly Drawing, K22200
8.4.1 Polymers
Silicon rubber
Santroprene
PVC (Polyvinylchloride)
PEEK (Polyetherketone)
PEX (Polyethylene)
PP (Polypropylene)
PP (Polypropylene reinforced with talcum)
PSU (Polysulphone)
PVDF (Polyvinylidene fluoride)
PTFE (Polytetrafluoro ethylene)
Parylene C
8.4.2 Metals
Stainless steel SS2343
Stainless steel SS2353
Stainless steel SS2562
Titanium
Platinum
8.4.3 Others
Carbon
Ceramic, Steatite 221
Ceramic, Aluminum oxide (Al2O3)
8.5.1 Operation
If condensation occur when moving the equipment between locations with different
temperatures and high relative humidity (e.g. outdoor and indoor locations), the inside
of the equipment shall be allowed to dry before switching on the equipment.
8.5.3 Energy
Typical energy consumption for a 4 hour treatment with inlet water temperature of 5 C
and 500 ml/h main flow is 2.7 kWh. Energy delivery to the environment is
approximately 400 Wh independent of inlet water temperature.
Energy delivery to the drain during a 4 hour treatment is 2.3 kWh.
The temperature at the drain can be up to 80 C.
Power consumption and delivery to the drain decrease with approximately 19 W for
every degree increase of inlet water temperature.
purposes.
Harmonic emissions Class A (Not applicable for 115
IEC 61000-3-2 V version)
80 MHz to 800
aFieldstrengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile
radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To
assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the AK 200 ULTRA S dialysis machine is used exceeds
the applicable RF compliance level above, the AK 200 ULTRA S dialysis machine should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating
the AK 200 ULTRA S dialysis machine.
bOver the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
NOTE!
At 80 MHz and 800 MHz, the higher frequency range applies.
These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
2W - - 0.33
GSM/3G
For transmitters rated at a maximum output power not listed above, the recommended separation distance d
in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is
the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE!
At 80 MHz and 800 MHz, the separation distance for the higher frequency range
applies.
These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
8.6 Standards
The machine complies with the following standards:
IEC 60601-1 General requirements for safety, Class I, type B
IEC 60601-2-16 Particular requirements for safety of haemodialysis, haemodiafiltration
and haemofiltration equipment
IEC 60601-2-30 Particular requirements for the safety of automatic cycling indirect
blood pressure monitoring equipment
IEC 60601-1-2 Electromagnetic compatibility
EN 1060-1 Non-invasive sphygmomanometers Part 1: General requirements
EN 1060-3 Non-invasive sphygmomanometers Part 3: Supplementary requirements
for electromechanical blood pressure measuring systems
NFS 90-304 Medico-surgical equipment Hemodialysis equipment
During repair of any of the parts in the flow path, special care should be taken and a
good hygiene should be kept.
Recordsforeach sub-testareincluded inthe end ofthisinstruction. The purpose of
these records is to documentthe work done and to trend the readings from the tests.
NOTE!
If the machine is tested according to IEC 60601-11, this complies with the
requirements in IEC 623532.
1 IEC 60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential
performance.
2 IEC 62353: Medical electrical equipment - Recurrent test and test after repair of medical electrical
equipment.
NOTE!
Limit values for PET-test according to IEC 62353.
Use test equipment according to IEC 62353.
NOTE!
To avoid damages on the safety tester, follow the instructions for the safety
tester.
4) There must be a fluid flow during this test. Make sure that the fluid is not in
bypass.
5) Measure the patient leakage current with the safety tester. Follow the user manual
for the safety tester .
6) Measure both in N.C. (Normal Condition) and S.F.C. (Single Fault Condition).
7) Take the highest AC-reading when the machine is running.
8) Take the highest DC-reading when the machine is running.
9) Invert the phases of the mains voltage. The machine may restart.
NOTE!
* For treatments with a central venous catheter (CVC), the patient leakage
current shall be < 10 A AC at Normal Condition (N.C.).
Machine identification
Product code
Serial number
Run time (h)
Remarks:
9 Electrical Safety Inspection
File both the highest AC-reading and the highest DC-reading, when the machine is
running, according to the section PLT - Patient Leakage Current Test in this chapter.
Compare with the measured leakage currents at the last1 ESI and evaluate if the
changes are approved or not for the next operational period of the machine.
Write notes below:
Notes:
This record is to be signed and filed by the Service Engineer responsible for the
Electrical Safety Inspection
1 If this is the ESI at installation please make comparison with the Production Summary measured values
supplied by the manufacturer at delivery of the machine.
11 Calibration manual
Guidelines for the AK 200 S / AK 200 ULTRA S dialysis machine, related to Service
and Maintenance:
During transportation and storage: AK 200 S / AK 200 ULTRA S dialysis machine
must for practical reasons be rinsed and drained, however, as soon as the
machine is installed, the disinfection schedule should be followed.
During repair of any of the parts in the flow path, special care should be taken and
a good hygiene should be kept.
Used and repaired spare parts may be used in the AK 200 S / AK 200 ULTRA S
dialysis machine if they are cleaned and repaired in a good way.
A general guide line is that the ultrafilters should be mounted on the
AK 200 S / AK 200 ULTRA S dialysis machine as well as the disinfection schedule
should be followed, as soon as the machine is connected to the water supply.
WARNING!
After completing the check and calibrations, the conductivity value must always be
confirmed by the hospital laboratory or equivalent.
Before calibration
Perform:
1. A decalcification to remove calcium precipitates.
2. A disinfection to remove organic residuals.
For details, refer to the AK 200 S / AK 200 ULTRA S Operators Manual. This is not
necessary if this has been done during maintenance.
11 Calibration manual
3) Press the Start UF Stop button to enter calibration routine.
4) Measure the voltage between TP 3 (earth) and TP 1 (ref) on the FM CPU board.
(See figure below.)
5) Set the REF SET on the display to the value shown on the voltmeter (min. 48.96
mV max. 50.88 mV). Press the Arrow button to confirm.
6) Press the Start UF Stop button to load the value into the EEPROM.
5) Set the REF SET on the display to the value shown on the voltmeter (min. 48.96
mV max. 50.88 mV). Press the Arrow button to confirm.
6) Press the Start UF Stop button to load the value into the EEPROM.
11 Calibration manual
5) Set the REF SET on the display to the value shown on the voltmeter (min. 48.96
mV max. 50.88 mV). Press the Arrow button to confirm.
6) Press the Start UF Stop button to load the value into the EEPROM.
NOTE!
Calibrations of temperature transducers in heating vessel or conductivity cell
need special equipment and can only be performed at Gambro Lundia AB, Lund.
Equipment needed
Pressure reference instrument, Calibration tube set.
Procedure
1) Start the AK 200 S / AK 200 ULTRA S dialysis machine and let it run with fluid for
15 minutes.
2) Initiate drain. When the Rinse/Drain button starts to flash, enter the service menu,
Calibr / FM / Extern.
3) Set the display to:
7) Apply zero pressure by opening the three clamps A, B and C on the calibration
tube set.
8) Set the REF SET value on the display to 0 mmHg (with the Set knob).
9) Press the Arrow button below REF SET to enter the value and wait for the
calibration display.
11 Calibration manual
11) Set the REF SET value on the AK 200 S / AK 200 ULTRA S dialysis machine
display to the same value as shown on the reference instrument.
12) Press the Arrow button below REF SET to enter the value and wait for the
calibration display.
13) The machine will now ask you to confirm to enter sensitivity calibration. To
confirm: press the Arrow button below Yes.
14) Open clamp A and B, then close clamp A again. Apply a pressure of approx. +500
mmHg, shown on the reference instrument. Close clamp B.
15) Set the REF SET value on the AK 200 S / AK 200 ULTRA S dialysis machine
display to the same value as shown on the reference instrument.
16) Press the Arrow button below REF SET to enter the value and wait for the
calibration display.
17) Press the Start UF Stop button to load the value into the EEPROM.
18) Reconnect the fluid path to its original design after the calibration.
19) To exit from the Calibration routine, press the Hold button.
20) Always perform a Heat disinfection after the fluid path has been opened.
NOTE!
*If an error message is shown on the display at this point, press the Hold button
and start again from step 4. If the error still exists after a second try, check that
the calibration tubes are intact. If the tubes are correct, repeat the calibration
procedure with a new transducer. Ex. of calibration error message:
7) Apply zero pressure by opening the three clamps A, B and C on the calibration
tube set.
8) Set the REF SET value on the display to 0 mmHg (with the Set knob).
9) Press the Arrow button below REF SET to enter the value and wait for the
calibration display.
10) Close clamp A. Apply a pressure of approx. -500 mmHg, shown on the reference
instrument. Close clamp B.
11) Set the REF SET value on the AK 200 S / AK 200 ULTRA S dialysis machine
display to the same value as shown on the reference instrument.
12) Press the Arrow button below REF SET to enter the value and wait for the
calibration display.
13) The machine will now ask you to confirm to enter sensitivity calibration. To
confirm: press the Arrow button below Yes.
14) Open clamp A and B, then close clamp A again. Apply a pressure of approx. +500
mmHg, shown on the reference instrument. Close clamp B.
15) Set the REF SET value on the AK 200 S / AK 200 ULTRA S dialysis machine
display to the same value as shown on the reference instrument.
16) Press the Arrow button below REF SET to enter the value and wait for the
calibration display.
17) Press the Start UF Stop button to load the value into the EEPROM.
18) Reconnect the fluid path to its original design after the calibration.
11 Calibration manual
20) Always perform a Heat disinfection after the fluid path has been opened.
NOTE!
*If an error message is shown on the display at this point, press the Hold button
and start again from step 4. If the error still exists after a second try, check that
the calibration tubes are intact. If the tubes are correct, repeat the calibration
procedure with a new transducer. Ex. of calibration error message:
4) Disconnect tube no. 32 at the EVVA valve and block tube no. 32 by using a closed
tube.
5) Disconnect both end of tube no. K23473 at the pressure transducer unit.
6) Press the Start UF Stop button to enter calibration routine.
7) Set the REF SET value on the display to 0 mmHg (with the Set knob).
8) Press the lit Arrow button below REF SET to enter the value and wait for the
calibration display.
9) Connect a Pressure reference instrument (together with a calibration tube) in the
place of tube no. K23473 at the side of the pressure transducer unit that is
connected to the flow input pump unit.
10) Apply zero pressure by opening the three clamps A, B and C on the calibration
tube set.
11) Close clamp A. Apply a pressure of approx. +500 mmHg, shown on the reference
instrument. Close clamp B.
12) Set the REF SET value on the AK 200 S / AK 200 ULTRA S dialysis machine
display to the same value as shown on the Pressure reference instrument.
13) Press the lit Arrow button below REF SET to enter the value and wait for the
calibration display.
15) Press the Start UF Stop button to load the value into the EEPROM.
16) Reconnect the fluid path to its original design after the calibration.
17) Always perform a Heat disinfection after the fluid path has been opened.
11 Calibration manual
11) Press the Arrow button below REF SET to enter the value and wait for the
calibration display.
12) The machine will now ask you to confirm to enter sensitivity calibration. To
confirm: press the Arrow button below Yes.
13) Open clamp A and B, then close clamp A again. Apply a pressure of approx. +500
mmHg, shown on the reference instrument. Close clamp B.
14) Set the REF SET value on the AK 200 S / AK 200 ULTRA S dialysis machine
display to the same value as shown on the reference instrument.
15) Press the Arrow button below REF SET to enter the value and wait for the
calibration display.
16) Press the Start UF Stop button to load the value into the EEPROM.
17) Reconnect the fluid path to its original design after the calibration.
18) To exit from the Calibration routine, press the Hold button.
19) Always perform a Heat disinfection after the fluid path has been opened.
NOTE!
*If an error message is shown on the display at this point, press the Hold button
and start again from step 5. If the error still exists after a second try, check that
the calibration tubes are intact. If the tubes are correct, repeat the calibration
procedure with a new transducer. Ex. of calibration error message:
Equipment needed
Pressure reference instrument, Calibration tube set.
Procedure
1) Start the AK 200 S / AK 200 ULTRA S dialysis machine and let it run with fluid for
15 minutes.
2) Initiate drain. When the Rinse/Drain button starts to flash, enter the service menu,
Calibr / FM / Extern.
3) Set the display to:
NOTE!
Be careful - the carbon tube can easily be damaged. Pull the silicon connector
straight up.
7) Apply zero pressure by opening the three clamps A, B and C on the calibration
tube set.
8) Set the REF SET value on the display to 0 mmHg (with the Set knob).
9) Press the Arrow button below REF SET to enter the value and wait for the
calibration display.
10) Close clamp A. Apply a pressure of approx. -500 mmHg, shown on the reference
instrument. Close clamp B.
11) Set the REF SET value on the AK 200 S / AK 200 ULTRA S dialysis machine
display to the same value as shown on the reference instrument.
11 Calibration manual
13) The machine will now ask you to confirm to enter sensitivity calibration. To
confirm: press the Arrow button below Yes.
14) Open clamp A and B, then close clamp A again. Apply a pressure of approx. +500
mmHg, shown on the reference instrument. Close clamp B.
15) Set the REF SET value on the AK 200 S / AK 200 ULTRA S dialysis machine
display to the same value as shown on the reference instrument.
16) Press the Arrow button below REF SET to enter the value and wait for the
calibration display.
17) Press the Start UF Stop button to load the value into the EEPROM.
18) Reconnect the fluid path to its original design after the calibration.
19) To exit from the Calibration routine, press the Hold button.
20) Always perform a Heat disinfection after the fluid path has been opened.
NOTE!
*If an error message is shown on the display at this point, press the Hold button
and start again from step 4. If the error still exists after a second try, check that
the calibration tubes are intact. If the tubes are correct, repeat the calibration
procedure with a new transducer. Ex. of calibration error message:
7) Apply zero pressure by opening the three clamps A, B and C on the calibration
tube set.
8) Set the REF SET value on the display to 0 mmHg (with the Set knob).
9) Press the Arrow button below REF SET to enter the value and wait for the
calibration display.
10) Close clamp A. Apply a pressure of approx. -500 mmHg, shown on the reference
instrument. Close clamp B.
11) Set the REF SET value on the AK 200 S / AK 200 ULTRA S dialysis machine
display to the same value as shown on the reference instrument.
12) Press the Arrow button below REF SET to enter the value and wait for the
calibration display.
13) The machine will now ask you to confirm to enter sensitivity calibration. To
confirm: press the Arrow button below Yes.
14) Open clamp A and B, then close clamp A again. Apply a pressure of approx. +500
mmHg, shown on the reference instrument. Close clamp B.
15) Set the REF SET value on the AK 200 S / AK 200 ULTRA S dialysis machine
display to the same value as shown on the reference instrument.
16) Press the Arrow button below REF SET to enter the value and wait for the
calibration display.
17) Press the Start UF Stop button to load the value into the EEPROM.
18) Reconnect the fluid path to its original design after the calibration.
19) To exit from the Calibration routine, press the Hold button.
20) Always perform a Heat disinfection after the fluid path has been opened.
11 Calibration manual
and start again from step 4. If the error still exists after a second try, check that
the calibration tubes are intact. If the tubes are correct, repeat the calibration
procedure with a new transducer. Ex. of calibration error message:
Calibration schedule
An Offset calibration should be performed after one month in operation and then
every third month to verify the performance.
A Complete calibration procedure should be performed at installation and then every
12 months.
8) Press the Arrow button below REF SET and wait until the calibration display
returns.
NOTE!
If an error message is shown on the display at this point, check the buffer
solutions, the level in the bowl and repeat the procedure from step 1. If the error
still exists after a second try, replace the pH sensor.
9) Press the Start UF Stop button to load the value into the EEPROM.
10) Remount the pH sensor into the pH sensor housing.
NOTE!
If an error message is shown on the display at this point, check the buffer
solutions, the level in the bowl and repeat the procedure from step 1. If the error
still exists after a second try, replace the pH sensor.
11 Calibration manual
14) Press the Arrow button below Yes to confirm that the calibration continues.
15) When the calibration display returns, press the Start UF Stop button to load the
value into the EEPROM.
16) Remount the pH sensor into the pH sensor housing.
NOTE!
The pH sensor should be changed every eighteenth month.
14) Press the Start UF Stop button to store the calibration values.
15) Drain the AK 200 S / AK 200 ULTRA S dialysis machine and remount the standard
blood leakage cover.
NOTE!
*If an error message occurs during calibration: Check the position of the
calibration filter and repeat from point 1. If an error occurs after a 2nd try, change
the blood leakage detector.
11 Calibration manual
11.2.15 Inlet pressure regulator adjustment
Equipment needed
T-connector, short PEX tube, Pressure reference instrument, Calibration tube set.
Procedure
1) Turn off the water supply.
2) Disconnect the inlet water tube at the test point (just before the non-return valve)
according to following illustration.
3) Insert a T-connector and a short PEX tube just before the non-return valve. To
prevent water from entering the disk filter/reference instrument, insert an extra
volume of approx.100 ml between the T-connector and the calibration tube set.
Important! Use a disc filter, according to the figure above, to protect the reference
instrument.
4) Close clamp C.
5) Turn on the water supply.
6) Start theAK 200 S / AK 200 ULTRA Sdialysis machine. Perform a functional
check and wait until the conductivity and the temperature are stable. The fluid
path on the OP-panel must be green before the calibration begins.
7) Zeroset the Reference instrument, wait for stable reading.
8) Close clamp A and B. Open clamp C.
9) Adjust the inlet pressure regulator until the pressure measured at the reference
instrument is 900 mmHg (1.2 bar or 120 kPa).
10) Perform a Drain.
11) Turn off the water supply. Reconnect the fluid path to its original design after the
calibration.
12) Always perform a Heat disinfection after the fluid path has been opened.
NOTE!
Before conductivity calibration, Chemical cleaning must be performed, one with
Citric acid and one with Hypochlorite.
Check the temperature transducers since the temperature affects the
conductivity calculations.
To keep the temperature inside theAK 200 S / AK 200 ULTRA Sdialysis
machine, do not remove the blood monitor and make sure the plastic shield
covers the interior of the fluid monitor.
The main flow must be set to 500 ml/min.
FM 20 is the complete calibration for all conductivity transducers and is
recommended by Gambro. It is possible to select between several different
conductivity calibrations, to fit all needs. All these calibrations are done in the
same way as described below. Refer to Service Technician's Guide / Fluid
monitor flow diagram, calibration.
Procedure
1) Start theAK 200 S / AK 200 ULTRA Sdialysis machine.
2) Enter the service menu, Calibr / FM / Intern.
11 Calibration manual
4) Press the Start UF Stop button to enter calibration routine.
5) Place both the A and B pick-up tubes into the heating vessel. Connect the
reference instrument according to the figure below.
6) Press the Fluid bypass button if lit. Let theAK 200 S / AK 200 ULTRA Sdialysis
machine and the reference instrument stabilise at 0 mS/cm and 37C for at least
15 minutes.
7) Set the REF SET value on the display to the same value as shown on the
reference instrument with the Set knob .
8) Press the lit Arrow button below REF SET to enter value and wait for next display.
9) Put the A pick-up tube into the concentrate container and let
theAK 200 S / AK 200 ULTRA Sdialysis machine stabilize at 14 mS/cm and 37C
for 15 minutes.
10) Set the REF SET value on the display to the same value shown on the reference
instrument.
11) Press the lit Arrow button below REF SET to enter the value and wait for the
calibration display.
12) The machine will now ask you to confirm to enter sensitivity calibration.To confirm:
press the Arrow button below Yes.
13) Press the Start UF Stop button to load the value into the EEPROM.
NOTE!
Error code FCN 5.11 001 may be issued during the calibration. This can be
ignored.
11 Calibration manual
10) Press the lit Arrow button below REF SET to enter value and wait for next display.
11) Attach a SelectCart cartridge.
12) Let theAK 200 S / AK 200 ULTRA Sdialysis machine stabilize at 14 mS/cm and
37C for 15 minutes.
13) Set the REF SET value to the same value shown on the reference instrument.
14) Press the lit Arrow button below REF SET to enter the value and wait for the
calibration display.
15) The machine will now ask you to confirm to enter sensitivity calibration.To confirm:
press the Arrow button below Yes.
16) Press the Start UF Stop button to load the value into the EEPROM.
11.2.18.2 General
The level detector is used in the protective system for supervision of the SelectBag
concentrate flow.
It consists of an IR-LED and an IR-transistor placed on a fluid chamber. The goal is to
form a logical output if the chamber is filled with liquid or not. The sensitivity is
dependent on the modulation frequency that controls the IR-LED. This must be
calibrated by adjusting the fluid level and finding the correct frequency.
The calibration is performed automatically in theAK 200 S / AK 200 ULTRA Sdialysis
machine calibration routine and requires only a filled SelectBag container.
NOTE!
The machine should be run with fluid for approximately 15 minutes followed by a
Rinse/Drain before the calibration is performed.
When the level detector is calibrated with default value (i.e. the first time), this
value might cause the pump not to stop at full chamber since high level is not
detected. This will mean that fluid is pumped out through the disinfection port in
the SelectCart cartridge holder (lower port) during the priming phase.
To prevent that air is getting trapped inside the particle filter after the SelectBag
container holder (50 m), it is important that the particle filter is correct
positioned according to following illustration.
WARNING!
Avoid touching the plastic spike.
WARNING!
Be careful to avoid fluid from the SelectBag container splashing into your eyes.
4) Press the Start UF Stop button to load the value into the EEPROM.
11 Calibration manual
Possible reasons for problems are:
No SelectBag container inserted
Fluid tubes faulty connected/leaking
Pump volumes not calibrated
Defective level detector/misconnected
Air/foam is SelectBag fluid tubes and/or level detector chamber
Calibration values differ too much
Pumps defective or faulty connected
Defective FM CPU board
If no obvious errors are found, perform a new calibration.
If the calibration value storage was unsuccessful, the following attention is displayed:
11.2.19.2 General
This calibration is intended to be done after following work operations:
Exchange of the control pump
Exchange of the protective pump
Exchange of the FM CPU board
Exchange of the select node PROM
1) To prevent that air is getting trapped inside the particle filter after the SelectBag
container holder (50 m), it is important that the particle filter is correct positioned
according to following illustration.
WARNING!
Avoid touching the plastic spike.
WARNING!
Be careful to avoid fluid from the SelectBag container splashing into your eyes.
11 Calibration manual
4) Open the lower latch of the SelectCart cartridge holder.
The blue line on the Measuring cylinder indicates 250 ml. The Measuring cylinder
is graduated in 0.2 ml increments i.e. each small mark indicates 0.2 ml.
7) To enter the reference volume press the Arrow button below REF SET and the
calibration calculation starts.
8) When the result of the calculation is displayed, press the Start UF Stop button to
load the calibration values into the EEPROM.
11.2.19.5 Verification
Empty the Measuring cylinder. Insert a new SelectBag container to the holder. Repeat
step 6 to 10 according to the instruction above. Verify that the reference volume from
the Measuring cylinder is within 250 2 ml.
11.2.20.1 General
The BiCart Select protective system uses a flow restrictor measurement for
supervision of the main flow and the UF volume. The main flow is used in the
supervision of the ratio between SelectBag concentrate- and main flow.
The Flow out restrictor and the Flow in restrictor are used to form restrictor flow
measuring devices. By using the Flow Out Pressure (FOP) the main flow is calculated.
By using the Flow Input Pressure (FIP) in combination with FOP the UF is calculated.
11 Calibration manual
If the machine is operated at high altitude, e.g. the preset S550 is used, the FCH
must pass state 18 (SP 004) before entering Service mode.
A UF-cell calibration will automatically be followed by FRN calibration.
If following parts (in the table below) are exchanged/calibrated, a new FRN
calibration must be performed and the following conditions must be fulfilled:
Stable temperature and conductivity
De air chamber level must be over 13 mm
Degassing level must be 50 mm
Exchanged Calibrated Installed
FOP transducer x x
FIP transducer x x
FOP pump x
FIP pump x
pH cell x x x
Cond. cell B x
FOP restrictor x
FIP restrictor x
UF cell x x
FM CPU board x
This attention message is displayed when verification is done and passed. The
machine is ready for use.
1) Enter theAK 200 S / AK 200 ULTRA Sdialysis machine service menu, Calibr /
FM / Other / UF.
2) Press the Arrow button below Restr.
3) Attach a SelectCart cartridge.
The calibration will now be performed automatically. CALIB NR 0-6 will be
displayed during calibration.
This attention message is displayed when verification is done and passed. The
machine is ready for use.
Verification failed. The machine can not be used for treatment until a successful FRN
calibration has been performed.
11.2.21.2 General
When automatic calibration is chosen, the Time lamp is lit. Complete automatic UF
calibration calibrates the UF cell and the supervision flow meter. The UF calibration
unit is used as reference in the calibration. (Refer to the UF calibration unit - User
Guide, HCEN9786.)
NOTE!
All electrical connections must be done before the power is turned on to the
UF calibration box and theAK 200 S / AK 200 ULTRA Sdialysis machine. Be
aware of that there is no main switch on the UF calibration box.
Switch on the equipment in the following order:
a) Connect the UF calibration box to the mains.
b) Switch on the AK 200 S / AK 200 ULTRA S dialysis machine with the
main switch and then the ON/OFF button.
NOTE!
Do not change to manual calibration while the box is filling or emptying!
When the automatic UF calibration/Supervision flow meter calibration is finished, a
verification has to be done.
11 Calibration manual
UF calibration box and theAK 200 S / AK 200 ULTRA Sdialysis machine. Be
aware of that there is no main switch on the UF calibration box.
Switch on the equipment in the following order:
a) Connect the UF calibration box to the mains.
b) Switch on the AK 200 S / AK 200 ULTRA S dialysis machine with the
main switch and then the ON/OFF button.
NOTE!
Do not change to manual calibration while the box is filling or emptying!
When the automatic UF calibration/Supervision flow meter calibration is finished, a
verification has to be done.
1. Switch off theAK 200 S / AK 200 ULTRA Sdialysis machine with the ON/OFF
button and then the main switch.
2. Disconnect the UF calibration station (mains cable).
5) Set the REF SET on the display to the value shown on the voltmeter (min. 48.96
mV max. 50.88 mV). Press the Arrow button to confirm.
6) Press the Start UF Stop button to load the value into the EEPROM.
Procedure
1) Start theAK 200 S / AK 200 ULTRA Sdialysis machine and enter the service
menu, Calibr / BM.
2) Set the display to:
11 Calibration manual
Procedure
1) Start theAK 200 S / AK 200 ULTRA Sdialysis machine and enter the service
menu, Calibr / BM.
2) Set the display to:
11 Calibration manual
Procedure
1) Start theAK 200 S / AK 200 ULTRA Sdialysis machine and enter the service
menu, Calibr / BM.
2) Set the display to:
11 Calibration manual
11.3.5 Level Detector calibration (Air detector), BM 5
Equipment needed
Drip chamber, Pressure meter, Calibration tube set.
Procedure
1) Start theAK 200 S / AK 200 ULTRA Sdialysis machine and enter the service
menu, Calibr / BM.
2) Set the display to:
like condition is simulated as the pressure inside the drip chamber becomes
approximately the same as the venous pressure during treatment. The purpose
is to get a better contact between the chamber and the air detector head, which
results in a higher calibration value.
6) Wait for 2 minutes and then press the lit Arrow button.
7) The calibration is now performed automatically and the calibration factor is written
into the EEPROM.
8) The calibration result is displayed:
The value under LEVEL is the new alarm limit, which shall be 50 or higher. The
value under TRANSMIT is the transmission level, which is normally 255 but can
also be 160, if the air detector is exceptionally good.
The reason for the error is probably that the drip chamber was moved during the
calibration. Make sure that the drip chamber is correctly inserted, that there is no air
bubbles in the water and that the temperature is 37 C.
If the alarm limit is too high or too low, the following error message is displayed:
If the problem remains, the air detector is malfunctioning and must be replaced.
If the verification of the calibration fails, the following error message is displayed:
The reason for the error is probably that the drip chamber was moved during the
calibration. If the problem remains, some circuit is broken on the BM CPU board.
11 Calibration manual
Reference tube
Procedure
1) Start theAK 200 S / AK 200 ULTRA Sdialysis machine and enter the service
menu, Calibr / BM.
2) Set the display to:
5) Insert an empty reference tube in the priming detector. The reference tube shall
be from the same type of blood line as used during treatment.
6) Press the lit Arrow button.
7) The calibration is now performed automatically and the calibration factor is written
into the EEPROM.
8) The calibration result is displayed:
3) Start theAK 200 S / AK 200 ULTRA Sdialysis machine and enter the service
menu, Calibr / BM.
4) Set the display to:
NOTE!
If the pump segment has a different wall thickness, the occlusion of the pump must
be adjusted to the correct wall thickness.
Use the gauge pins (stop/go) available in the kit K40158001. The kit includes following
three different gauge pins:
T = 1.1 (Stop pin = 1.1x2x0.7 = 1.5mm)
T = 1.6 (Stop pin = 1.6x2x0.7 = 2.2mm)
T = 2.0 (Stop pin = 2.0x2x0.7 = 2.8mm)
T = wall thickness of the tubing
Use following formula to calculate which gauge pin to use:
2 x wall thickness x 0,7 (mm)
11 Calibration manual
below. Adjust range between the pump rollers and the path if it is necessary.
11 Calibration manual
automatically. Before entering the test mode cuff and cuff hose to be connected to
theAK 200 S / AK 200 ULTRA Sdialysis machine.
Cuff to be wrapped tight to the BPM test equipment. If the displayed time is above 11
seconds, this test indicates that the pump is worn-out.
NOTE!
The pressure transducer calibration tube kit must be drained before being
connected, to make sure that no fluids or particles enters the BPM connector or
tubings. This might otherwise damage or destroy the sensitive BPM sensors.
When Current pressure: xxx mmHg is displayed it is possible to start applying the
external reference pressure.
NOTE!
The BPM is equipped with an over pressure protection. It is activated for
pressures above 300 mmHg.
The pressure transducer test is to be performed within approx. 2 minutes. Then
the pressure is automatically released.
To check the actual pressure value, external pressure reference instrument to be
connected and external pressure of 250, 150, 50 mmHg to be applied. Check deviation
from reference pressure instrument for displayed value.
11.4.1 GXL-logging
When calibration has been performed, it is recommended to log the values shown in
the logging table, see Section 11.4.3 Logging values on page250.
To run GXL-logging, the following facilities must be available and connected as shown
in fig:
11.4.2 Procedure
Procedure
1) Start theAK 200 S / AK 200 ULTRA Sdialysis machine.
2) Press Volume Control button.
3) Set temperature value: 37.0 C.
4) Set main flow to: 500 ml/min.
5) Select suitable mode: BiCart, Acetate or Liquid Bicarbonate.
6) Let theAK 200 S / AK 200 ULTRA Sdialysis machine run for at least 15 minutes,
bypass off.
7) Start the GXL-program on the PC.
11 Calibration manual
SRI 89 Heat rods duty cycle % < 30.00 < 30.00 < 30.00
SRI 14 Temperature vessel C 37.50 0.50 37.50 0.50 37.80 0.50
SRI 15 Temperature cell A control C 37.20 0.50 37.40 0.50 37.40 0.50
SRI 116 Temperature cell A PRS C 37.20 0.50 37.40 0.50 37.40 0.50
SRI 16 Temperature cell B PRS C 37.00 0.50 37.00 0.50 37.00 0.50
SRI 115 Temperature cell B control C 37.00 0.50 37.00 0.50 37.00 0.50
SRI 13 Conductivity cell A control mS/cm 12.30a 0.50b 0 0.50b 9.50c 0.50b
SRI 114 Conductivity cell A PRS mS/cm 12.30a 0.50b 0 0.50b 9.50c 0.50b
SRI 12 Conductivity cell B control mS/cm 14.30a0.50b 14.00a0.50b 14.30a0.50b
SRI 11 Conductivity cell B PRS mS/cm 14.30a 0.50b 14.00a 0.50b 14.30a 0.50b
SRI 8 Degassing pressure mmHg -580.0a 20.0 -630.0a 20.0 -580.0a 20.0
SRI 10 Flow out pressure mmHg -175.0 40.0 -175.0 40.0 -175.0 40.0
SRI 6 HPG pressure mmHg -95d 25.0 -95d 25.0 -95d 25.0
SRI 7 SAG pressure mmHg -120 50.0 -120 50.0 -120 50.0
SRI 4 PD pressure mmHg -125 15.0 -125 15.0 -125 15.0
SRI 9 Flow in pressure mmHg +175 50.0 +175 50.0 +175 50.0
SRI 71 A-pump deviation % < 5.0 - < 5.0
SRI 72 B-pump deviation % < 5.0 - < 5.0
SRI 73 Ac-pump deviation % - < 5.0 -
SRI 97 Degassing pump duty cycle % < 75.0 < 70.0 < 70.0
SRI 31 Flow out pump duty cycle % < 50.0 < 50.0 < 50.0
SRI 35 Flow in pump duty cycle % < 50.0 < 50.0 < 50.0
SRI 0 System pressure mmHg 0.0 5.0 0.0 5.0 0.0 50
SRI 1 Venous pressure mmHg 0.0 5.0 0.0 5.0 0.0 5.0
SRI 82 Arterial pressure mmHg 0.0 5.0 0.0 5.0 0.0 5.0
SRI 24 Blood leakage detector valuee - 0 10 0 10 0 10
SRI 25 Flow rate channel 1 ml/min 500 1 500 1 500 1
SRI 26 Flow rate channel 2 ml/min 500 3 500 3 500 3
SRB 0 Level det. transmit level 255 or - - -
160
SRB 89 Level det. comparation level min. 50 - - -
max 98
SRB 2 Priming detector blood level 15 - - - -
236
aCan be preset
bMaximum difference between conductivity cell A & B = 0.3 mS/cm. Maximum difference within a cell is 0.2 mS/cm
cDefault liquid concentrate
dDepending on pressure drop in ultrafilter (ULTRA or UFD)
eMachine in blood mode and no pressure at safety guard during 1 minute.
3ELECT
.ON
3ELECT "AG 0"6!
RETURN
VALVE &/6! 2ESTRICTOR
0RESSURE &ILTER
REGULATOR &EEDING PUMP ! &LOW &LOW
0
OUTPUT OUTPUT
&ILTER
"#6! &EEDING PUMP " PUMP PRESSURE
406! :%6!
&ILTER "I#ART
"I#ART
"LOOD LEAK
"UBBLE TRAP DETECTOR 5&
MEASURING
&LOW INPUT %66! %-6! CELL
PRESSURE 0 4
#OND
&LOW INPUT CELL #
$EAIRATING
2ESTRICTOR PUMP
0URE 0ARTICLE 0 CHAMBER WITH
WATER FILTER 0$ LEVEL DETECTOR 4!6!
INLET
(#%. 'AMBRO ,UNDIA !" 2EV 0210
0
3!' 3AFETY (0'
$RAIN 0 BY
PASS
"96!
UNIT
$)6!
0URE WATER
3ELECT"AG CONCENTRATE
3ELECT#ART CONCENTRATE
! CONCENTRATE
"