Professional Documents
Culture Documents
HCEN9794 Revision.08.2003
Program version 10.xx
Contents
1. Before you get started - general information
Definitions of expressions used in this manual . . . . . . . . . . . . . . . . . .
General precautions before use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Safety philosophy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Inlet water requirements and frequency of filter exchange . . . . . . . . .
Ultra Filtered Dialysis Fluid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
List of concentrates, accessories and disposables, for use with the
AK 95 S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
List of symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
CE-marking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Manufacturer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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HCEN9794 Revision.08.2003
Program version 10.xx
Override possibilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Stand-by group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Display and setting group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Information display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Viewing Angle Adjustment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
The eight commandments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Setting of parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
The following parameters can be set: . . . . . . . . . . . . . . . . . . . . . . .
Chemical disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Heat disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Rinse/Drain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Acetate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Bicarbonate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Venous pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Blood flow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Single needle data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Temperature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Conductivity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Arterial pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
TMP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
UF volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
UF rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Heparin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
BPM (option) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Setting of the pressure alarm limits . . . . . . . . . . . . . . . . . . . . . . . . . . .
The ultrafiltration control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Recovery from power failure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Returning the blood during a power failure . . . . . . . . . . . . . . . . . .
Change of blood pump segments . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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4. Treatment operations
Initial procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
First check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Start the machine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
For acetate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
For bicarbonate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Attaching the filter and the blood lines . . . . . . . . . . . . . . . . . . . . . . . .
Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Arterial blood line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Venous blood line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Dialysis fluid tubes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Priming and rinsing the extracorporeal circuit . . . . . . . . . . . . . . . . . . .
Before priming . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
High venous pressure test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Initiating dialysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Setting of treatment parameters . . . . . . . . . . . . . . . . . . . . . . . . . . .
Connect the patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Start of ultrafiltration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Set the alarm limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
BPM (option) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
High arterial pressure alarm limit setting . . . . . . . . . . . . . . . . . . . .
Minimize the risk of generating microbubbles . . . . . . . . . . . . . .
HCEN9794 Revision.08.2003
Program version 10.xx
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9. Alarm lists
Alarm list . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9:2
Attention alarm list . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9:10
Technical alarm list . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9:41
Complete manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Chapter 1 and 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Chapter 6 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Chapter 7 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Chapter 9 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
The minual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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11. Index
HCEN9794 Revision.08.2003
Program version 10.xx
Figures
2. Description - the machine with its components
Figure 2:1
Figure 2:2
Figure 2:3
Figure 2:4
Blood unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Fluid unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Mixing unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Rear of the machine . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2:2
2:4
2:6
2:8
Operator's Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Flow diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3:4
3:8
4. Treatment operations
Figure 4:3
Figure 4:4
Figure 4:5
Figure 4:6
Figure 4:9
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HCEN9794 Revision.08.2003
Program version 10.xx
HCEN9794 Revision.08.2003
Program version 10.xx
Chapter 1
Before you get started - general
information
Definitions of expressions used in this manual . . . . . . . . . . . . . . . . . .
General precautions before use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Safety philosophy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Inlet water requirements and frequency of filter exchange . . . . . . . . .
Ultra Filtered Dialysis Fluid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
List of concentrates, accessories and disposables, for use with the
AK 95 S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
List of symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
CE-marking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Manufacturer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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Program version 10.xx
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1:1
CAUTION
Is used to alert the user/operator to take a certain action to
protect against a possible hazard which, if ignored, could have
an adverse effect on the patient or the equipment. A caution
may also be used to alert the user/operator not to take a
certain action to avoid the potential hazard as above.
NOTE
A reminder to the user/operator on normal treatment activity
and on what is a suitable action in a particular situation.
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HCEN9794 Revision.08.2003
Program version 10.xx
CAUTION
1. The AK 95 S may only be operated by persons trained in
hemodialysis and who have studied the instructions in this
manual. The user/operator should draw special attention
towards the text valid for the Safety philosophy of the machine.
See section Safety philosophy in chapter 1. Verify that the
first digit of the program version of both the machine and
the manual is the same. If the AK 95 S does not perform
as described in this manual, it should not be used until the
condition is rectified.
2. When unpacking, check the equipment for any signs of
damage. If the equipment is in any way damaged, proper
operation can not be assured.
3. Patients connected to life supporting equipment, such as the
AK 95 S should be monitored by competent medical personnel,
learned intermediaries or the like, since life threatening
circumstances sometime arise that may not activate alarms.
The operator should pay attention to all appropriate alarms and
follow the instructions, warnings, cautions, and notes given in
this manual. It is imperative to check life supporting equipment
for proper operation before use.
4. During installation all calibration checks must be completed
before the machine is used to dialyse a patient.
5. The use of mobile telephones or communication equipment
in the vicinity of the AK 95 S could adversely influence the
performance of the machine.
6. The AK 95 S will perform as designed only if it is used and
maintained in accordance with Gambros instructions. Any
warranties made by Gambro with respect to the AK 95 S
are void if the equipment is not used in accordance with the
instructions provided. Gambro will not accept responsibility
for any damage or injury resulting from improper use or
maintenance or unauthorized repair.
HCEN9794 Revision.08.2003
Program version 10.xx
1:3
CAUTION
7. The preventive inspections, maintenance and calibration of the
AK 95 S shall be performed according to the AK95/AK 95 S
Service Manual, Maintenance Manual HCEN9137 which
can be ordered from your Gambro representative. Periodic
maintenance should be performed after every 2500 hours of
operation or at least yearly.
8. When using central venous catheters, it is strongly
recommended that the potential equalization conductor
is connected to the dialysis machine and to the potential
equalization bus bar in the electrical installation to minimize the
risk of electric shock.
Any equipment within the patient area shall fulfil the IEC
60601-1 and IEC 60601-1-1 or equivalent safety standard, and
be a part of the potential equalization.
NOTE
1. This operators manual provides instructions necessary for
the proper operation of the AK 95 S. It is not a guide for the
administration of hemodialysis.
2. Machines are not disinfected before delivery. Always perform a
chemical disinfection after installation, before initial use.
3. When accuracy ranges are written as e.g. (1 ml/min or 1%)
the widest range is valid.
4. During transportation and storage the equipment has to be
kept in its original packing. If transportation or storage time is
more than 15 weeks the environmental data relating to the
operation has to be followed.
5. For the qualified technician the AK 95 S Service Manual is
available. The Service Manual provides all of the necessary
information for the safe and required maintenance of the
machine.
6. It is important that the protective earth in the installation is of
high quality.
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HCEN9794 Revision.08.2003
Program version 10.xx
Intended use
The Gambro AK 95 S System is designed to be used as a single patient
machine to perform hemodialysis treatments upon prescription by a
physician. Patient counselling and teaching of treatment techniques are
directly under the supervision and discretion of the physician.
AK 95 S comprises of three units; one blood unit, one fluid unit and
one mixing unit.
The blood unit is designed to control and supervise the extracorporeal
blood circuit. Single needle treatment can be performed with one pump
(double clamp function). To prevent coagulation, anticoagulantia may
be administered by means of a heparin pump.
The fluid unit is designed to administer the dialysis fluid and to control
the ultrafiltration.
The mixing unit is designed to proportion concentrate(s) with reverse
osmosis water. Both acetate and bicarbonate treatments can be
performed.
CAUTION
1. Patient education, counselling, home care follow-up and
medical maintenance must be performed under the direction
of and supervision by the physician prescribing the treatment.
Gambro specifically denies any responsibility for patient
education, counselling or home care and medical maintenance.
2. When AK 95 S is used to produce bicarbonate containing
dialysis fluid originating from non-liquid concentrates, the
AK 95 S is designed and validated for use with the Gambro
BiCart system. Gambro does not accept responsibility for use
of other non-liquid concentrate containers.
HCEN9794 Revision.08.2003
Program version 10.xx
1:5
Safety philosophy
The AK 95 S is designed according to the current standards for
hemodialysis equipment, IEC 60601-2-16. This means that safety
under so-called Single Fault Conditions is granted. In practice this
means that controllable treatment parameters (i.e. conductivity,
temperature and ultrafiltration) are controlled by one system, the
control system, and monitored by another completely separate
protective system, utilizing its own sensors, electrical circuits and
microprocessors. The functionality of the protective system is checked
by the AK 95 S before each treatment. A fault detection during the
pretreatment tests will make it impossible to start the treatment.
In order to verify that the corresponding control and protective systems
are operating with the correct input values, the user is instructed
to compare the readings of the current bargraph display and the
information display, before connecting the patient. The bargraph
displays show the set value, the actual value and the alarm limits for
the control system. The information display shows the corresponding
values from the protective system. If the comparisons are not
satisfactory, call your service technician.
The protective system will, when a parameter (measured by the
protective system) is outside the alarm limits, put the AK 95 S into a
patient-safe condition. This means that the protective system can stop
the blood pump, close the venous clamp, prevent the dialysis fluid
from reaching the filter and alert the operator with sound and light.
For the ultrafiltration control system, the transmembrane pressure
(TMP) is used as the protective system. Alarm limits for TMP related
to the dialysis filter UF coefficient and the expected UF rate, are to be
set around the actual TMP value when starting treatment. The TMP
alarm limit correspond to a UF-deviation limit described by TMPAlarm
limit x UFkoefficient. Example: If the alarm window is set to 50 mmHg
and the UF-koefficient is 10 ml/mmHg x h the maximum weight
deviations without any alarm is 500 g/h. As default the alarm window
is set to 100 mmHg. It is essential to ensure that the alarm window
is set as close as possible to the working TMP. As an additional
precaution it is recommended that competent personnel supervise the
patient and that the blood pressure is checked regularly.
To protect the patient against a hazardous blood loss to the environment
AK 95 S incorporates a venous pressure monitoring system. This
system will react upon a change in the venous pressure, i.e. when the
pressure falls below the low alarm limit. It must be observed that under
certain pressure/flow conditions a blood loss to the environment may
not be able to cause the venous pressure to fall below the low alarm
limit. To avoid blood loss to the environment it is essential to ensure
that all connections in the extracorporeal blood circuit are tight and
secured, that the fistula needle is correctly positioned and secured and
that the low alarm limit is set as close as possible to the working venous
pressure. A visual monitoring by the user/operator is recommended.
The venous pressure measuring system is the protection against
blood loss to the environment. This measuring system is checked
automatically at 0 mmHg before each treatment. A failure will make it
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Calcium
Magnesium
Sodium
70
Potassium
Fluoride
0,2
Chlorine
0,5
Chloramines
0,1
Nitrate (N)
Sulphate
100
Copper
0,1
Barium
0,1
Zinc
0,1
Aluminium
0,01
Arsenic
0,005
Lead
0,005
Silver
0,005
Cadmium
0,001
Chromium
0,001
Selenium
0,09
Mercury
0,0002
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Area of use
001-099 series
6xx series
2xx series
7xx series
8xx series
3xx series
Non-liquid concentrates
Area of use
BiCart
CAUTION
Incorrect choice of dialysis fluid concentrate may cause
incorrect composition of the dialysis fluid.
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HCEN9794 Revision.08.2003
Program version 10.xx
Lines
Line number
Area of use
BL 100 series
AV 100 series
A 5000 series
V 5000 series
Gambro Accessories
C series
Hemodialysis accessories.
C 705
Filters
HCEN9794 Revision.08.2003
Program version 10.xx
Filter name
Area of use
U 8000 S
Dialysis filters
1:11
Area of use
No.1 (7 cm)
No.2 (9 cm)
No.3 (12 cm)
No.4 (14 cm)
CAUTION
1. The AK 95 S has been tested and validated for use with the
concentrates, accessories and disposables specified above.
2. Gambro does not accept any responsibility or liability for use
of concentrates, accessories or disposables other than those
specified above. Depending on the circumstances, use of
concentrates, accessories or disposables other than those
specified above may also reduce Gambros warranties for the
AK 95 S.
NOTE
1. The user should make sure to have a current listing of
concentrates, accessories and disposables available.
2. The user should follow the facility procedures for proper
disposal of used blood lines, dialyzers and other disposables
per local regulations.
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List of symbols
NOTE
All symbols in this list may not be represented on this product.
Description
Alternating current
Protective earth (ground)
This way up
Keep dry
Input /Output
Year of manufacturing
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Prohibited behaviour
Equipotentiality
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HCEN9794 Revision.08.2003
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CE-marking
This product is CE-marked in accordance with the requirements in EC
Council Directive 93/42/EEC of 14 June 1993 concerning medical
devices and is classified as IIb equipment.
Notified body is: British Standards Institution (BSI) with the notified
body number 0086.
The CE-marking of this manual is only valid if the device which it
describes is CE-marked.
Manufacturer
Gambro Lundia AB, Monitor Division,
Box 10101, SE-220 10 LUND, Sweden.
Phone +46 46 169000.
Copyright
Gambro Lundia AB, 1996
HCEN9794 Revision.08.2003
Program version 10.xx
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HCEN9794 Revision.08.2003
Program version 10.xx
Chapter 2
Description - the machine with its
components
Blood unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Fluid unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Mixing unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Rear of the machine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
HCEN9794 Revision.08.2003
Program version 10.xx
2:2
2:4
2:6
2:8
2:1
Blood unit
1001
1
2
15
3
14
13
17
7
5
4
6
12
9
10
16
Figure 2:1
B
Acetate
11
8
10
Blood unit
1. Top tray
To protect the machine against leakage the top tray must always be
placed on top of the machine.
2. Operator's panel
As an option, the operator's panel can be mounted in an external
housing. The remote panel is easy to adjust in different positions
and the handling procedures will be the same.
3. Air detector
The air detector head is designed for a drip chamber with a diameter
of 22 mm. The ultrasonic air detector will detect air or foam in
the venous drip chamber.
4. Venous pressure transducer connector
2:2
HCEN9794 Revision.08.2003
Program version 10.xx
HCEN9794 Revision.08.2003
Program version 10.xx
2:3
Fluid unit
Figure 2:2
Fluid unit
2:4
HCEN9794 Revision.08.2003
Program version 10.xx
HCEN9794 Revision.08.2003
Program version 10.xx
2:5
Mixing unit
8
6
5
4
1
2
8
7
1005
Figure 2:3
Mixing unit
1. Service frame
A service tray can be placed on top of the service frame if this is
pulled out.
2. Bars, lifting positions
Positions where the AK 95 S is safely lifted.
3. Wheels
Four wheels of which the two at the front side are lockable. The
brakes are not designed to hold the AK 95 S when it is tilted.
4. Tray for concentrate containers
Tray for the conentrate container(s).
5. BiCart holder
The machine is designed to be used with Gambro's BiCart system,
a cartridge containing dry bicarbonate powder.
During disinfection mode, also used as a holder for CleanCart-C
and CleanCart-A, cartridges containing a cleaning agent.
6. Red concentrate connector
This connector is used for the separately attached A-concentrate
pick-up tube (A pick-up tube).
2:6
HCEN9794 Revision.08.2003
Program version 10.xx
HCEN9794 Revision.08.2003
Program version 10.xx
2:7
1
2
8
3
4
5
1006
6
7
Figure 2:4
2:8
HCEN9794 Revision.08.2003
Program version 10.xx
Chapter 3
Controlling the machine - general
guidelines
Operator's panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Hygiene group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Mode group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Treatment overview group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Flow diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Mode buttons and Parameter buttons and their displays . . . . . . . . . . .
Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Alarm indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Air detector alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Attention alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Technical message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
pH alarm (option) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Blood leak alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
BPM alarm (option) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Alarm function of the parameter buttons . . . . . . . . . . . . . . . . . . . .
Venous pressure alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Centralizing alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Blood pump alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Single needle data alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Temperature alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Conductivity alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Arterial pressure alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Centralizing alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Transmembrane pressure alarm . . . . . . . . . . . . . . . . . . . . . . . . . . .
Centralizing alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Clinic Automation alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
UF volume alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
UF rate alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Heparin pump alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Time attention alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Override possibilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Stand-by group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Display and setting group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Information display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Viewing Angle Adjustment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
The eight commandments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Setting of parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
The following parameters can be set: . . . . . . . . . . . . . . . . . . . . . . .
Chemical disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Heat disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Rinse/Drain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Acetate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Bicarbonate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Venous pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Blood flow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Single needle data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Temperature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Conductivity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Arterial pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
HCEN9794 Revision.08.2003
Program version 10.xx
3:4
3:6
3:7
3:8
3:8
3:9
3:15
3:15
3:15
3:15
3:15
3:15
3:15
3:15
3:16
3:16
3:16
3:16
3:16
3:16
3:16
3:16
3:16
3:16
3:17
3:17
3:17
3:17
3:17
3:17
3:18
3:19
3:21
3:21
3:21
3:23
3:24
3:25
3:25
3:25
3:25
3:25
3:25
3:25
3:25
3:25
3:25
3:26
3:26
3:1
TMP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
UF volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
UF rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Heparin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
BPM (option) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Setting of the pressure alarm limits . . . . . . . . . . . . . . . . . . . . . . . . . . .
The ultrafiltration control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Recovery from power failure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Returning the blood during a power failure . . . . . . . . . . . . . . . . . .
Change of blood pump segments . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3:2
3:26
3:26
3:26
3:26
3:26
3:26
3:27
3:28
3:29
3:30
3:31
HCEN9794 Revision.08.2003
Program version 10.xx
HCEN9794 Revision.08.2003
Program version 10.xx
3:3
Operator's panel
The blood unit, the fluid unit and the mixing unit are controlled and
supervised from the operator's panel. The panel consists of a number of
buttons, bargraph displays, flow paths, a time display, an information
display, a blood flow knob and one set knob.
The panel is divided into five logical groups:
Figure 3:1
Operator's Panel
1. Hygiene group
These buttons are used to select machine modes mainly related to
disinfection, rinsing and draining of the fluid unit and the mixing
unit.
2. Mode group
The buttons in this group are used to select different treatment
modes.
3. Treatment overview group
This group graphically shows the status of the treatment and allows
for a complete overview of all important treatment parameters.
3.1. Bargraph display
3.2. Flow diagram
3.3. Time display
3:4
HCEN9794 Revision.08.2003
Program version 10.xx
4. Stand-by group
These buttons can be used for direct control and stand-by of certain
functions.
5. Display and setting group
The two buttons and the set knob are used for setting of all
parameters except the blood flow. The blood flow is always directly
controlled with the blood flow knob. The information is shown on
the information display.
5.1. Information display
5.2. Blood flow knob
5.3. Set knob
HCEN9794 Revision.08.2003
Program version 10.xx
3:5
Hygiene group
The ON/OFF button is used to switch the machine on and off. The
main switch on the back side of the monitor should always be in the
ON position (even when the machine is not in use).
The machine can not be turned off during treatment, i.e. when
treatment time is not 0.00 and blood has been detected by the priming
detector. But if no blood has been detected by the priming detector the
machine can be turned off even if the time is not 0.00.
The Chem disinf button is used to select chemical disinfection. As
soon as the dwell time is completed, an automatic rinse will start. The
dialysis fluid tubes must be connected to the safety couplings when the
chemical disinfection mode is entered. The mode can not be selected
during treatment.
The Heat disinf button is used to select heat disinfection (heat
disinfection alone or in combination with a citric acid or CleanCart
disinfection). The dialysis fluid tubes must be connected to the safety
couplings when the heat disinfection mode is entered. The mode can
not be selected during treatment.
The Rinse/Drain button is used to select rinsing and draining mode. It
is also possible to discontinue the heat disinfection and the chemical
disinfection programs by pressing Rinse/Drain button. The dialysis
fluid tubes must be connected to the safety couplings when the rinse
or draining mode is entered. Rinse or drain can not be selected during
treatment.
The Auto Heat button is lit when auto heat has been programmed. The
machine performs a heat disinfection at a predetermined time, set by
the operator (auto heat alone or in combination with CleanCart).
The Auto Rinse button is lit when auto rinse has been programmed. The
machine performs a rinse at a predetermined time, set by the operator.
NOTE
The above mentioned buttons must be pressed for at least 3
seconds in order to activate/deactivate the functions
3:6
HCEN9794 Revision.08.2003
Program version 10.xx
Mode group
The Isol UF button is used to select isolated ultrafiltration (sequential
dialysis). The fluid preparation has to be completed in order to enter
the mode.
The SN button is used to select single needle treatment.
SN is performed by using the arterial and venous clamps, and may be
controlled and supervised by either time or pressure.
The Acetate button is used to select acetate treatment.
The Volume control button is used to start the fluid preparation 1. The
function can be preset as active when the machine is switched on or it
can be activated manually by pressing the button. Once the function
is activated, it is not possible to deactivate it.
1
HCEN9794 Revision.08.2003
Program version 10.xx
Can be preset
AK 95 S Operators manual - Controlling the machine
3:7
6
1036
3
Figure 3:2
3:8
Flow diagram
HCEN9794 Revision.08.2003
Program version 10.xx
Information
display
PERACE
3,5 %
HYPOCHL
10 %
FORMAL 37 %
RINSE
HCEN9794 Revision.08.2003
Program version 10.xx
HEAT
Explanation
TME NOW
XX 00.00
RDY DAY
XX
RDY TIME
00.00
TME NOW
XX 00.00
RDY DAY
XX
RDY TIME
00.00
3:9
Bargraph
display
-
Information
display
Explanation
ACC TIME
ACC UF
TIME
ISOL UF
Yellow bar
Red bars
D01
D94
D53
D201
D360
D300
VEN PRES
LOW HIGH
Actual value
Alarm limits
3:10
Red bars
LOW
Green Bar
SET
SEGMENT
Actual value/Accumulated
volume
Low alarm limit for the blood
flow delayed a presettable time
(0-60 min)
Set value
Blood pump segment diameter
HCEN9794 Revision.08.2003
Program version 10.xx
Bargraph
display
Information
display
LOW
Green bar
ART FLOW
SEGMENT MM
VEN
ART
SET
TEMP
LOW HIGH
Set value
Actual value
Alarm limits
NA
SET COND
COND
STROKE ML
LOW
Green bar
Yellow bar
Red bars
Explanation
In acetate mode
Green bar
Yellow bar
Red bars
In bicarbonate mode
NA, HCO3SET COND
Green bar
COND
Yellow bar
Red bars
HCEN9794 Revision.08.2003
Program version 10.xx
Yellow bar
Red bars
ART PRES
LOW HIGH
Actual value
Alarm limits
Yellow bar
Red bars
TMP
LOW HIGH
Actual value
Alarm limits
3:11
Bargraph
display
Information
display
Explanation
Clinic Automation
An external computer system
which is associated with patient
related information
.....
......
.......
Yellow bar
ACC UF
Green bar
SET UF
UFR
3:12
Accumulated ultrafiltration
volume
Set ultrafiltration value
Calculated UF
Actual value
Filter type
Priming UF rate
Minium UF rate
Calculated UF rate
Alarm limits
Actual value
Filter type
UF rate during isol UF
Minimum UF rate during
treatment
Alarm limits
Actual value
Filter type
Calculated UF rate
Minimum UF rate during
treatment
Alarm limits
HCEN9794 Revision.08.2003
Program version 10.xx
Bargraph
display
Information
display
Explanation
SET
ACC
STOP LIM
ACC VOL
SET VOL
Accumulated volume
Set volume
PASSED
The
TIME-display
always shows the
REMAINING
treatment time
(h.min) during
treatment
NON-DIFF
SET TIME
UFR
HCEN9794 Revision.08.2003
Program version 10.xx
3:13
Bargraph
display
Information
display
Explanation
3:14
Depending on which
disinfection/rinse program that is
being performed, the information
display will show different
displays. The information display
will show the different phases of
the program and the remaining
time of each phase.
HCEN9794 Revision.08.2003
Program version 10.xx
Alarms
Alarm indicators
The alarm indicators will light up in certain alarm situations. The Mute
button will flash and the buzzer will sound. Press the illuminated alarm
indicator to obtain further information on the information display.
Air has been detected in the venous drip chamber by the air detector.
When the button flashes, it indicates that the fault has been corrected.
Press the button in order to reset the alarm. During priming the button
may be lit, but as the air detector is not yet activated, the machine will
take no actions.
It is possible to deactivate the air detector in priming phase by pressing
the Priming button to exit the priming mode and to press the Priming
button once more to enter priming mode again.
Attention alarm
Technical message
pH alarm (option)
Blood has been detected by the blood leak detector. When the button
flashes, it indicates that the fault has been corrected. Press the button
to reset the alarm. During priming the button may light up, but, as
the blood leak detector is not yet activated, the machine will take no
actions.
HCEN9794 Revision.08.2003
Program version 10.xx
3:15
Steady light
The venous pressure is outside the set limits.
Centralizing alarm
Flashing light
The venous pressure limits are too wide.
Steady light
The blood pump stop time has expired.
or
The blood flow has been lower than the low alarm limit for more than
five minutes (default).
Steady light
The stroke volume during SN is lower than the set low alarm limit.
Temperature alarm
Steady light
The temperature of the dialysis fluid is outside the set limits.
Conductivity alarm
Steady light
The conductivity of the dialysis fluid is outside the alarm limits.
Steady light
The arterial pressure is outside the set alarm limits.
Centralizing alarm
Flashing light
The arterial pressure limits are too wide.
3:16
HCEN9794 Revision.08.2003
Program version 10.xx
Centralizing alarm
Flashing light
The TMP limits are too wide.
Steady light
The connection to the external computer system has been interrupted.
UF volume alarm
Flashing light
The set UF volume is set to zero when the priming detector detects
blood.
UF rate alarm
Steady light
The UF rate is lower than the set minimum UF rate. Adjust the time,
the UF volume or the min UF.
Flashing light
The set heparin rate is set to zero when the priming detector detects
blood.
Flashing light
The treatment time has expired.
HCEN9794 Revision.08.2003
Program version 10.xx
3:17
Override possibilities
The alarm indicators for:
air detector
blood leak
3:18
HCEN9794 Revision.08.2003
Program version 10.xx
Stand-by group
The Blood pump button is used to start (constant light) and stop
(flashing light) the blood pump at the selected flow rate. If the blood
pump is stopped when the selected flow rate is 0 ml/min, the light of
the button goes out.
Pressing the Blood pump button (flashing) during treatment will
automatically widen the venous pressure, arterial pressure and TMP
alarm windows (flashing buttons). To centralize the alarm limits
around the actual values, press the corresponding flashing buttons. The
maximum permitted stop time for the blood pump during treatment is
1-3 min (can be preset). When this time has expired an attention alarm
will be activated instructing the operator to restart the pump, the buzzer
will sound and the Blood flow button will flash.
The Reset button is used to set the following accumulated values to
zero: UF volume, treated blood volume, heparin volume, Isol UF
volume, passed time and non-diffusion time. Also all parameters are
set to their preset values.
If a treatment is started and neither disinfection nor rinse have been
performed after the previous treatment, an attention alarm will be
given:
If the Reset button is pressed in this case, all accumulated values will
be set to zero but the parameters will not be set to their preset values.
If the Select arrow button is pressed neither accumulated values nor
parameters will be set to zero.
NOTE
1. No reset can be made if the blood pump has been started
and/or the Start/UF/Stop button has been pressed. In this case
the blood pump must be stopped and/or the Start/UF/Stop
button must be pressed again in order to make a reset.
2. No reset can be made during the test of the UF-cell. This has
to be done either before or after the test.
HCEN9794 Revision.08.2003
Program version 10.xx
3:19
The Mute button is used to silence the buzzer for varying times
depending on the alarm. The mute times for the different alarms are
shown in the alarm and the attention alarm lists (see chapter 9).
There are three kinds of buzzer sounds:
By pressing the Mute button during treatment the ten most recent
treatment alarms can be displayed on the information display. The
information display sign must be extinguished and the buzzer must
not be active.
The most recent alarm will be shown first. Then, by using the Set knob,
previous alarms will be displayed in historical order.
The alarms which can be displayed are:
Ven Press High, Ven Press Low, Art Press High, Art Press Low, TMP
High, TMP Low, SN Stroke Low, Blood Flow Low, Temp High, Temp
Low, Cond Alarm, pH Alarm, Air Detector Alarm, Art Guard Alarm
and Blood leak Alarm.
The Fluid bypass button is used to manually bypass the dialysis fluid
from the filter. If the button is pressed when the dialysis fluid has the
desired temperature and conductivity the button will flash (even if
there is no alarm on the fluid side).
When the Fluid bypass button has flashed for 5 min. during treatment
an attention alarm appears, instructing the operator to press the button.
The Start UF Stop button is used to start and stop the controlled
ultrafiltration. The button flashes when the blood detector detects
blood.
The ultrafiltration will start when the flashing Start UF Stop button
is pressed.
NOTE
By pressing the Start/UF/Stop button during treatment the
ultrafiltration rate is reduced to the set minimum UF rate. The
permitted stop time can be preset between 1-10 minutes.
When this time has expired, an attention alarm will be given
instructing the operator to restart the ultrafiltration.
3:20
HCEN9794 Revision.08.2003
Program version 10.xx
2.
3.
4.
2.
3.
4.
HCEN9794 Revision.08.2003
Program version 10.xx
3:21
The Set knob is used for setting of all parameters, except for the blood
flow.
The Blood flow knob is used to set the blood flow. The Blood flow knob
is directly accessible, i.e. without first having to press the Blood Flow
button. The information display lights up when the knob is turned.
3:22
HCEN9794 Revision.08.2003
Program version 10.xx
PASSE
0:00
8. The blood flow rate may always be changed directly with the Blood
flow knob.
The handling concept for the operator is based completely on the eight
commandments above.
HCEN9794 Revision.08.2003
Program version 10.xx
3:23
Setting of parameters
All treatment parameters are set in a similar way.
For parameters that have one low and one high limit, both limits
can be changed simultaneously by pressing the Select arrow button
once again.
35
37
39
50
100
40
Temp
Press the Select arrow button once or repeatedly to choose set value,
low, high or both alarm limits. If the purpose is to move the alarm
window, both low and high limits must flash.
The adjustable parameter(s) text and the corresponding scale(s) on
the bargraph display will flash.
Turn the Set knob and change the set value or alarm limits. A change is
made both on the information and bargraph displays.
The light of the information display goes out and the bargraphs turn
into a constant light 15 seconds after the Set knob was touched.
However, it is possible to select new information on the information
display by pressing another button before the 15 seconds have passed.
If the temperature needs to be studied in digital form for more than 15
seconds, press the Hold button. The Set knob is then disconnected.
3:24
HCEN9794 Revision.08.2003
Program version 10.xx
Heat disinfection
A heat disinfection program alone or in combination with citric acid or
with CleanCart can be selected with the Select arrow button.
Rinse/Drain
The rinse time can be changed by the Set knob .
Acetate
Three types of acetate concentrates can be selected with the Select
arrow button.
Bicarbonate
Three combinations of acid and bicarbonate concentrates can be
selected with the Select arrow button.
Venous pressure
The low and high alarm limits can be changed with the Set knob either
together or separately or by the centralizing function.
Blood flow
The Blood flow knob is directly accessible i.e. without first having to
press the parameter button.
Temperature
The set value, the low and high alarm limits for the temperature may
be changed with the Set knob. The alarm limits can be changed either
together or separately.
HCEN9794 Revision.08.2003
Program version 10.xx
3:25
Conductivity
In acetate mode, the set value for sodium may be changed with the Set
knob. In bicarbonate mode, the set values for sodium and bicarbonate
may be changed. The conductivity alarm limits are automatically
calculated to the set value 5 %. Both high and low limits for Na+ and
HCO3- in Acetate (only Na+) and bicarbonate modes can be preset.
Arterial pressure
The low and high alarm limits can be changed with the Set knob either
together or separately or by the centralizing function.
TMP
The low and high alarm limits for the transmembrane pressure can
be changed with the Set knob either together or separately or by the
centralizing function.
UF volume
The set value for the ultrafiltration volume during diffusion may be
changed with the Set knob.
UF rate
The priming UF rate and minimum UF rate in treatment/priming may
be changed with the Set knob.
NOTE
If the calculated UF rate is lower than the set minimum UF rate,
the machine will not go below this set minimum UF rate. An
attention alarm will be given.
Time
The remaining treatment time may be changed with the Set knob.
Heparin
The set value for the heparin flow rate and the stop time for the
heparinization (time before treatment stop) may be changed with the
Set knob. If the blood pump is stopped the heparin pump will continue
to run if it is not stopped manually.
BPM (option)
It is possible to set modes and alarm limits for the BPM (Blood Pressure
Monitor) function. See Modes and/or Alarms in chapter 6.
3:26
HCEN9794 Revision.08.2003
Program version 10.xx
HCEN9794 Revision.08.2003
Program version 10.xx
3:27
Ultrafiltration volume
UF rate
Treatment time
Treatment time and UF volume may be set within certain limits. The
machine will automatically calculate and show the UF rate. When
treatment time or UF volume is changed the UF rate will also change.
An example of how a UF setting is done is shown below:
1. Press the Time button and select the treatment time.
2. Press the UF volume button and select set UF volume. (As soon as
the Select arrow button is pressed, the bar on the UF rate display
also starts to flash, showing the calculated UF rate).
3. When the flashing Start UF Stop button has been pressed (light
on), the TMP alarm limits must be centralized. Note that the alarm
limits should be set in accordance with the UF rate and filter UF
coefficient.
NOTE
When negative TMP alarm limits are set, an attention 2 will
indicate that no backfiltration warning will occur. This attention
has to be confirmed.
3:28
Can be preset
AK 95 S Operators manual - Controlling the machine
HCEN9794 Revision.08.2003
Program version 10.xx
An attention will appear and the buzzer sounds. The text reC is
shown on the time display. The operator must confirm the restart by
pressing the flashing Time button. The machine will then continue the
treatment from where it was interrupted.
The machine can also be preset to run only with the blood pump after a
power failure. In this case another attention alarm will be displayed:
When the Select arrow button is pressed, the fluid monitor will start.
CAUTION
Check treatment parameters after a recovery.
NOTE
If the attention
HCEN9794 Revision.08.2003
Program version 10.xx
3:29
3:30
HCEN9794 Revision.08.2003
Program version 10.xx
HCEN9794 Revision.08.2003
Program version 10.xx
3:31
3:32
HCEN9794 Revision.08.2003
Program version 10.xx
Chapter 4
Treatment operations
Initial procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
First check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Start the machine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
For acetate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
For bicarbonate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Attaching the filter and the blood lines . . . . . . . . . . . . . . . . . . . . . . . .
Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Arterial blood line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Venous blood line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Dialysis fluid tubes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Priming and rinsing the extracorporeal circuit . . . . . . . . . . . . . . . . . . .
Before priming . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
High venous pressure test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Initiating dialysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Setting of treatment parameters . . . . . . . . . . . . . . . . . . . . . . . . . . .
Connect the patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Start of ultrafiltration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Set the alarm limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
BPM (option) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
High arterial pressure alarm limit setting . . . . . . . . . . . . . . . . . . . .
Minimize the risk of generating microbubbles . . . . . . . . . . . . . .
Single needle treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Isolated UF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Discontinuing dialysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Returning the blood . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Emptying and disconnecting the filter . . . . . . . . . . . . . . . . . . . . . .
HCEN9794 Revision.08.2003
Program version 10.xx
4:2
4:2
4:3
4:4
4:4
4:5
4:5
4:6
4:10
4:10
4:12
4:12
4:14
4:15
4:15
4:15
4:17
4:17
4:18
4:18
4:19
4:20
4:23
4:24
4:24
4:25
4:1
Initial procedures
NOTE
In the machine has been stored with a chemical disinfectant,
this solution must be rinsed out of the system before any
treatment can be initiated.
First check
That the main switch on the rear of the monitor is turned on.
That the drain tube is properly connected to the machine and placed
with an air gap between the drain tube and the drain.
That the dialysis fluid tubings are connected to the safety couplings.
CAUTION
In order to protect the operators fingers, keep the blood pump
and the clamp covers shut during the function check for the
blood unit since the pump as well as the clamps will be tested
during the check.
NOTE
1. When the machine starts it always carries out an internal safety
check. This check requires that the dialysis fluid tubes are
connected to the safety couplings. The dialysis fluid tubes
must remain connected to the safety couplings until FCh has
disappeared from the time display.
2. When the machine is connected to power and the main switch
is in ON position, a lit segment is shown on the TIME display.
4:2
HCEN9794 Revision.08.2003
Program version 10.xx
NOTE
In order to finalize the function check, the A-concentrate/acetate
must be connected and the venous drip chamber filled to the
correct level. The reason is, that the conductivity cells must be
checked with conductivity and the air detector must be checked
with fluid in the chamber. When the function check is finished,
the treatment time appears on the time display.
2. Check that the correct mode and concentrate(s) are used. (The
start-up mode may be preset.)
NOTE
During the conductivity test in function check it is not possible
to change between Bicarbonate and Acetate mode. If the
conductivity check during function check was performed in
Acetate mode it is not possible to switch to Bicarbonate mode
during treatment. However, it is always possible to change from
Bicarbonate to Acetate mode during treatment.
HCEN9794 Revision.08.2003
Program version 10.xx
4:3
For acetate
a.
b.
Press the Cond button to set the sodium value. The start-up
sodium value can be preset.
c.
For bicarbonate
a.
b.
Press the Cond button to set the sodium and bicarbonate value.
The start-up sodium and/or bicarbonate value can be preset.
c.
NOTE
Fixed conductivity alarm limits (5 %) will be set automatically,
centred around the conductivity set value as shown on the
bargraph.
3. Check all the set values and the alarm limits. Adjust if necessary.
CAUTION
Before preparing the machine for treatment, check that the
mode and the set values are correct.
4:4
HCEN9794 Revision.08.2003
Program version 10.xx
CAUTION
To avoid safety hazards, when attaching the blood lines to the
machine it is important to:
follow the instructions given in the package inserts for the
blood lines
NOTE
Since tests of the blood pump and the clamps are included
in the function check, it is important that the blood lines are
attached either before power on or when the Priming button
has been lit.
If the blood lines have been attached and primed before
the function check has been initiated, the venous pressure
transducer protector must not be connected until the function
check for the blood unit is completed.
Filter
Set up the filter according to the instructions for the specific filter.
Place the filter in the holder.
HCEN9794 Revision.08.2003
Program version 10.xx
4:5
4. Filter connection
Attach the connector to the blood port on the top of the filter.
5. Arterial line clamp
Place the patient -end of the arterial line into the line clamp colour
-coded with the red dot.
6. Heparin pump
WARNING
The operator must take proper precaution in order to prevent
coagulation in the extracorporeal circuit.
Coagulation may lead to:
inadequate delivery of dialysis
NOTE
Make sure that the heparin pump is adjusted for the syringe
size that is being used.
4:6
HCEN9794 Revision.08.2003
Program version 10.xx
3
2
1
6
1009
4
5
Figure 4:3
HCEN9794 Revision.08.2003
Program version 10.xx
4:7
Figure 4:4
To change the position of the piston, press the end of the piston, hold it
in and move the holder. When the piston is released the holder cannot
move.
Insert the syringe in the pump; the plastic collar at the end of the
syringe must fit in the groove of the pump.
Push back the piston and insert the plastic plate on the plunger in
the groove by the locking wheel.
Turn the locking wheel upwards until resistance is felt. This is to lock
the plastic plate of the plunger in the groove.
Check that the syringe is properly secured by lightly pulling the
plunger out of the pump.
Pulling
direction
Figure 4:5
EN1068
Locking
direction
HCEN9794 Revision.08.2003
Program version 10.xx
If the set value is 0 when the priming detector detects blood, the
Heparin button starts to flash and an attention is given.
CAUTION
To prevent the syringe from loosening from the heparin pump
during treatment the syringe plunger has to be thoroughly
secured. Check by lightly pulling the plunger out of the pump.
When doing so, it must be impossible to pull the syringe out of
the heparin pump.
HCEN9794 Revision.08.2003
Program version 10.xx
4:9
4:10
HCEN9794 Revision.08.2003
Program version 10.xx
4
1
2
3
1010
Figure 4:6
HCEN9794 Revision.08.2003
Program version 10.xx
4:11
Check that the priming UF rate is correct (follow the instruction for
use of the filter).
It is possible to prime the blood compartment of the filter and the blood
lines during disinfection or during the function check when the Priming
button has been lit. If priming has been done during disinfection the
venous pressure transducer protector must not be connected until the
function check for the blood unit is completed.
1. Check that the Priming button is lit.
2. Press the flashing Blood pump button. The blood flow rate will
automatically start at 100 ml/min. Adjust the blood flow. Prime
and de-air the blood lines and the filter.
3. Follow the instructions for the use of the filter and the blood lines.
4. Adjust the level in the drip chamber, so the level is well above the
air detector head.
5. When the level in the air detector is correct, the Air detect button
will start flashing and an attention without buzzer regarding the
inactivated air detector will appear. The attention will remain until
the air detector is activated (manually when desired/automatically
when blood is detected).
6. When the priming volume 1 has been achieved, the blood pump
automatically stops and the attention:
4:12
Can be preset
AK 95 S Operators manual - Treatment operations
HCEN9794 Revision.08.2003
Program version 10.xx
CAUTION
1. The operator must check that the blood pump stops when the
upper venous pressure limit is reached.
2. The operator must check the functionality of the arterial
pressure transducer by clamping the arterial line before the
arterial pressure transducer and check that the changes in the
arterial pressure are shown on the bargraph display.
7. Activate the dialysis fluid, if this is not done yet, by pressing the
flashing Fluid bypass button, the button will light up.
The time display lights up when the conductivity test is finished,
the dialysis fluid has the correct temperature, the venous drip
chamber is filled with fluid to the correct level and the air detector
test is finished.
HCEN9794 Revision.08.2003
Program version 10.xx
4:13
the air detector has been tested and there are no alarms from it
the dialysis fluid has entered the filter (i.e. when both
compartments of the filter have been filled with fluid).
2. b. Press the Select arrow button and correct according to the three
conditions mentioned above.
If no correction is made at this point or if the high venous pressure
test is not initiated by the operator when the first attention appears,
the attention concerning the high venous pressure test will
disappear when the priming detector detects blood.
4:14
HCEN9794 Revision.08.2003
Program version 10.xx
Initiating dialysis
Setting of treatment parameters
CAUTION
To avoid hazardous side effects during the treatment, the
parameters and the alarm limits shall be suitable for the
patients needs and tolerance.
HCEN9794 Revision.08.2003
Program version 10.xx
4:15
The machine will remain in blood state until the treatment time =
0:00 and end of treatment is confirmed, even if the venous line is
removed from the priming detector.
In the case where one treatment is completed, and another is started
without a reset being made, the following attention alarm will appear:
If the Select arrow button is pressed the accumulated values will not be
reset. Press the Reset button to reset the accumulated values.
4:16
Can be preset
AK 95 S Operators manual - Treatment operations
HCEN9794 Revision.08.2003
Program version 10.xx
NOTE
No reset can be made if the blood pump has been started
and/or the Start/UF/Stop button has been pressed. In this case
the blood pump must be stopped and/or the Start/UF/Stop
button must be pressed again in order to make a reset.
Start of ultrafiltration
Press the Start/UF/Stop button (lights up) to start ultrafiltration.
If the Start/UF/Stop button is not pressed within 5 minutes after the
priming detector is activated, an attention alarm will appear.
NOTE
If the patient's blood pressure drops during treatment it is
advisable to press the Start/UF/Stop button. The ultrafiltration
rate will immediately decrease to a minimum, but with the
treatment time still counting down. There will be an attention
alarm after 5 minutes asking the operator to restart the
ultrafiltration. If it is desired to continue the volume control
or the isolated UF with the same parameters, press the
Start/UF/Stop button. The ultrafiltration rate will slowly increase
to the set value.
3
HCEN9794 Revision.08.2003
Program version 10.xx
Can be preset
AK 95 S Operators manual - Treatment operations
4:17
BPM (option)
If the BPM (Blood Pressure Monitor) function is to be used, set modes
and alarm limits according to instructions in chapter 6.
CAUTION
If the upper arterial alarm limit is adjusted by preset, the
following alarm situations may not be detected during treatment:
a disconnection of the arterial line
NOTE
Negative pressure may cause generation of microbubbles.
4:18
HCEN9794 Revision.08.2003
Program version 10.xx
HCEN9794 Revision.08.2003
Program version 10.xx
Make sure that all connections in the extracorporeal circuit are tight.
Ensure that the blood flow rates are compatible with needle/catheter
lumen size and blood access/blood flow characteristics.
4:19
1011
possible.
Figure 4:9
4:20
HCEN9794 Revision.08.2003
Program version 10.xx
HCEN9794 Revision.08.2003
Program version 10.xx
4:21
2. Check that there is no air in the blood lines and that the venous
drip chamber is well above the air detector head. The expansion
chambers are filled to the correct levels (refer to the instruction for
use of the individual blood line).
3. Activate the air detector by pressing the Air detector button.
NOTE
If the air detector is not activated manually by pressing the
Air detector button, it will automatically be activated when the
priming detector detects blood.
4:22
Can be preset
AK 95 S Operators manual - Treatment operations
HCEN9794 Revision.08.2003
Program version 10.xx
Isolated UF
Follow the instructions in this chapter up to Connect the patient.
Isolated ultrafiltration can be performed before, during or after the
normal dialysis treatment.
1. Press the Isol UF button
Set the required treatment time for the Isol UF phase.
Set the required UF volume for the Isol UF phase
There are two different alternatives to preset the machine, concerning
time and UF volume.
The time and UF volume set for the Isol UF phase will be added
to the time and UF volume set for the diffusion phase. This
means that the total treatment time and UF volume will increase.
The time and UF volume set for the Isol UF phase will decrease
the treatment time and UF volume set for the diffusion phase.
This means that the total treatment time and UF volume will
not be changed.
2. Press the Isol UF button for 3 seconds, the button illuminates.
3. Check that the calculated UF rate is not too high, adjust treatment
time or UF volume if necessary.
4. Continue to Connect the patient in this chapter
When the time for the isolated ultrafiltration phase is finished, the
machine will automatically switch to diffusion.
Adjust the TMP alarm limits when the TMP has stabilized.
NOTE
1. The time in isolated ultrafiltration mode is included in the
passed treatment time and also in the treatment without
diffusion (non-diffusion time). The UF volume achieved in
isolated ultrafiltration mode is included in the total accumulated
UF volume.
2. If heparinization is desired during the entire UF phase, set the
heparin stop time to 0:00. Check/adjust the heparin stop time
when the machine has switched to diffusion.
HCEN9794 Revision.08.2003
Program version 10.xx
4:23
Discontinuing dialysis
When the remaining treatment time reaches 0:00, the following occur:
To finish the treatment, press the flashing Time button for 3 seconds.
NOTE
1. If the treatment is to be continued press the flashing Time
button briefly and set a new treatment time. The alarm will
then be cleared and it is possible to increase the UF volume,
or mini UF rate set to zero.
2. If the treatment time is turned down to 0:00 and there is still
time left under isolated UF an attention will appear. If the
treatment is to be finished without performing the isolated UF,
press the Isol UF button and turn down the time to 0:00.
4:24
HCEN9794 Revision.08.2003
Program version 10.xx
When the priming detector does not detect blood any more, the red
light of the flow diagram goes out, the Priming button lights up and the
blood pump stops (the Blood pump button flashes).
If more rinse-back is required, press the flashing Blood pump button
to continue.
7. Disconnect the venous blood line from the patient.
CAUTION
The venous line must be disconnected from the patient before
emptying the fluid side of the filter, i.e. connecting one of the
fluid tubes to the safety coupling. Otherwise the negative
pressure created by the machine in order to empty the filter
may cause a blood flow from the blood compartment to the
fluid compartment of the filter.
Can be preset
AK 95 S Operators manual - Treatment operations
4:25
NOTE
If combined heat and CleanCart is selected, the conductivity
value must be below 2 mS/cm before the CleanCart is attached.
CAUTION
If the venous pressure transducer protector or the arterial
pressure transducer protector show signs of damage, i.e.
blood is appearing on the transducer side of the protector, it is
necessary to call for a service technician who must replace the
tubing set and the disk filter inside the machine.
NOTE
The machine must not be switched off without at least being
rinsed.
4:26
HCEN9794 Revision.08.2003
Program version 10.xx
Chapter 5
Auto priming, Rinse-back
Auto priming (Option) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
General description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Filling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Pressure test (Option) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Priming . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Flushing part one . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Flushing part two . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Venous drip chamber level adjustment (Option) . . . . . . . . . . . . . . .
Filling of venous line (Option) . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Dialysis fluid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Operation of the autopriming . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Rinse-back . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
General description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Operation of the Rinse-back . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
HCEN9794 Revision.08.2003
Program version 10.xx
5:2
5:2
5:2
5:2
5:2
5:2
5:3
5:3
5:3
5:3
5:4
5:9
5:9
5:9
5:1
Filling
The filling phase is the first phase in the auto priming procedure.
During this phase the blood compartment of the dialysis filter and the
blood lines are filled with priming solution. The filling time (Fill time:
0-60:00 min) and the filling flow rate (Fill flow: 0-500 ml/min) can
be preset. The priming UF rate (Priming UF Rate: 0-4.0 l/hour) must
be preset. If a heparin infusion is required during priming, this must
be preset (Heparin set flow: 0-10.0 ml/hour).
Priming
The priming phase is the third phase of the auto priming procedure. In
this phase the air bubbles are removed from the filter by opening and
closing the venous clamp intermittently, while the blood pump runs.
The priming time (Priming time: 0-60:00 min), the priming flow rate
(Priming flow :0-500 ml/min) and the opening/closing times for the
clamps (Priming cycle time: 0-1:00 min) can be preset.
5:2
HCEN9794 Revision.08.2003
Program version 10.xx
Dialysis fluid
The dialysis fluid can be preset to flush through the filter automatically
(FM active: Install/Not Install). It is also possible to preset when the
dialysis fluid should flush through the filter, before or after the blood
lines have been rinsed (Early start of FM: Install/Not Install).
HCEN9794 Revision.08.2003
Program version 10.xx
5:3
The text below in italics is an example of how to use the auto priming
feature, using a Gambro Polyflux 11 S. Assume that 1.5 litres of
priming solution is to be used. This is only an example. The presets
must be set in accordance with the respective users needs.
In the following example the default preset data are used:
Filling:
Priming will consist of 400 ml of total priming volume and the venous
clamp will have an opening/closing time of 3 seconds.
Priming UF rate:
Flow: 0
FM active: Inst
Early start of FM:Not Inst
This means that the dialysis fluid will automatically enter the filter
when flushing part one starts (if the dialysis fluid is correct).
Flushing part one:
5:4
HCEN9794 Revision.08.2003
Program version 10.xx
Level time: 0
This means inactivation of the last venous line filling and flush.
1. Set up the blood lines and the filter on the monitor, follow the
instructions in chapter 4 "Treatment operations - Attaching
the filter and the blood lines". If a venous drip chamber level
adjustment is to be performed, use a special extension tube (auto
priming line C-1055), which is placed from the top of the venous
drip chamber into the arterial clamp and the arterial blood line is
placed outside the arterial clamp.
No special extension tube is used, since the drip chamber level
adjustment will be done manually. Therefore the arterial line is placed
inside the arterial clamp and the preset for the drip chamber level
adjustment are set to 0 (Level time:0).
2. Connect the arterial line to the container with priming solution.
Place the free end of the venous line in an empty container.
3. If the machine is turned off, turn it on by pressing the On/Off
button, add the concentrate(s), follow the instructions in
Treatment operations - Start the machine. Check that the mode
and the set values are correct.
The priming UF rate is: 0.6-1.5 l/h when a Gambro Polyflux 11 S filter
is used.
NOTE
The dialysis fluid has to flush from bottom to top of the filter to
ensure a proper deaeration.
Therefore the filter must be inverted in accordance with this
when the dialysis fluid enters the filter during flushing part one.
4. a. Wait until FCh has disappeared from the time display. Take the
dialysis fluid tubes from the safety couplings and place them on
the filter. The filter has to be flushed from bottom to top in order to
remove air from the dialysis fluid compartment. There are three
different alternatives to preset the flushing of the dialysis fluid.
HCEN9794 Revision.08.2003
Program version 10.xx
5:5
will be given.
FM active - install and Early start of FM - not install: the dialysis
fluid will automatically enter the filter during flushing part one.
b. If no dialysis fluid is required during the priming phase, the auto
priming function can be activated as soon as the Priming button lights
up.
5. Press the Auto Priming button briefly and choose the desired
alternative with the Select arrow button. Activate the auto priming
by pressing the Auto Priming button for 3 seconds. The Auto
Priming button lights up.
6. Check that the venous pressure high limit is set according to the
instructions for the specific filter (set to +200 mmHg for Gambro
fibres). If a heparin infusion is required during priming, this must
be preset.
7. Invert the filter (arterial end downwards).
8. Start the auto priming procedure by pressing the Blood pump
button. The procedure may be stopped and started at any time by
pressing the Blood pump button, which flashes when priming is
stopped. If a start of the auto priming procedure from the beginning
is required, press the Auto Priming button for 3 seconds to exit the
mode and press the same button, for 3 seconds, to start again.
Now the blood pump automatically starts to fill the blood lines and the
filter at a preset rate and for a preset time.
The fluid unit keeps the preset priming UF rate. Verify that all air has
been removed from the arterial blood line when the filling procedure is
completed.
The pressure test of the filter is performed by setting the preset
parameters concerning the pressure test. If they are set to 0, the
pressure test is cancelled. If the pressure test is selected, an information
text appears:
5:6
HCEN9794 Revision.08.2003
Program version 10.xx
The test starts by pressing the flashing Blood pump button. The venous
clamp closes, and at the selected venous high pressure limit the blood
pump stops. If a fault is detected there will be an attention
During Flushing part one the blood lines and the filter are rinsed
with priming solution. If the preset is set to FM active the dialysis
fluid will enter the filter at this time. If the fluid preparation is not
completed, the process stops and waits until it is completed. The blood
pump stops after a presettable time. The flushing part one flow rate
will be the same as for the Priming phase.
9. When it is time to do a final flush before connecting the patient,
press the flashing Blood pump button. There will also be an
attention alarm reminding of this. Now the flushing part two starts
and runs for a preset time. The flushing part two flow rate will be
the same as for the Priming phase.
If the AK 95 S is preset to do a venous drip chamber level adjustment,
the blood pump stops and the venous clamp closes. The arterial clamp
opens and the blood pump starts to fill up the venous drip chamber.
When it is filled to an appropriate level the arterial clamp closes again.
Preset set to Level time: 0. The reason for not using this is the
risk of contamination. A special line must be attached to the venous
HCEN9794 Revision.08.2003
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5:7
Disconnect the special line from the top of the venous drip
chamber. Connect either a cap or a syringe to the free end of the
drip chamber. Remove the special line from the arterial clamp.
Place the arterial blood line in the arterial clamp.
11. Press the flashing Auto Priming button until the light goes out.
12. Turn the filter back to its correct position, arterial end upwards.
13. The machine is ready for treatment. Follow the instructions in
chapter 4 Treatment operations- Initiating dialysis.
5:8
HCEN9794 Revision.08.2003
Program version 10.xx
Rinse-back
General description
Rinse-back is a feature which can be preset that is used when the
treatment is to be finished. It enables the AK 95 S to automatically
rinse the blood lines and the filter, while the venous clamp opens and
closes intermittently. This is to maximize the emptying of blood from
the blood lines and the filter.
The blood pump now runs at a preset flow rate (preset: 25-500 ml/min).
During the rinse-back the venous clamp opens and closes 1 time/s in
order to maximize the emptying of the blood lines and the filter.
The blood pump stops, the Rinse-back button and the Blood pump
button start to flash and an attention appears. When a preset volume
(Preset: 200-5000 ml) of rinse-back solution has been returned to the
patient or when the priming detector does not detect blood any more,
which ever comes first.
6. Clamp the venous blood line and disconnect it from the patient.
To proceed, follow the instructions in Treatment operations-Emptying
and disconnecting the filter.
HCEN9794 Revision.08.2003
Program version 10.xx
5:9
5:10
HCEN9794 Revision.08.2003
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Chapter 6
BPM - Blood Pressure Monitor
(option)
General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:2
The cuff . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:2
Handling BPM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:2
Patient factors affecting readings . . . . . . . . . . . . . . . . . . . . . . . . . . 6:3
Menus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:4
The first menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:4
The second menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:5
The third menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:5
Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:6
Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:7
Manual - single measuring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:8
Automatic - interval measuring . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:9
Continuous - five minutes measuring . . . . . . . . . . . . . . . . . . . . . . . 6:11
BPM Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:13
HCEN9794 Revision.08.2003
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6:1
General
The Blood Pressure Monitor (BPM) measures blood pressure and
pulse rate.
It is possible to use the BPM at any time whenever the machine is in its
on position i.e. when the ON/OFF button is lit.
In addition to the BPM included in the machine, a blood pressure
measurement cuff and a cuff hose are necessary.
The cuff
The line from the cuff (cuff hose) is attached to the side of the AK 95 S
(see Blood unit in chapter 2). The cuff and the cuff hose are
available in different sizes which can be ordered from your Gambro
representative (see List of concentrates, accessories and disposables,
for use with the AK 95 S).
It is important to use proper cuff size for accurate measurements. Use
the circumference of the patients arm to determine cuff size. If the
bladder is too wide, the blood pressure reading will be erroneously low;
if it is too narrow, the reading will be erroneously high. Apply the cuff
snugly so that one finger can fit between the cuff and the patients arm.
More information about how to choose the right cuff size, how to
connect the cuff to the cuff hose and the cuff hose to the machine can
be read in the package insert leaflet which is enclosed with the cuff
and cuff hose. The package insert leaflet also contains information
about how to properly put the cuff on the patient's arm.
Handling BPM
The BPM is handled via the information display using the BPM button,
the Select arrow button and the Set knob (see Operator's panel in
chapter 3).
Menus are shown on the information display when the BPM button
is pressed. Every time the BPM button is pressed the menus change
in sequence.
The Select arrow button is used to move within the menus (between
the subsections) on the information display.
The Set knob is used to move within the subsections in the menus on
the information display.
NOTE
If the BPM button is pressed when no BPM has been installed,
the information display will remain dark.
6:2
HCEN9794 Revision.08.2003
Program version 10.xx
CAUTION
1. Check that the blood circulation in the arm is not affected due
to blood pressure measurement checks.
2. The Blood Pressure Monitor must be used only for adult
patients or for children with a pediatric cuff and not for infant or
neonatal patients.
3. The manufacturer advises the user that the information
originating from the Blood Pressure Monitor cannot be used
alone as unique source of information to induce any therapeutic
or pharmacological actions.
HCEN9794 Revision.08.2003
Program version 10.xx
6:3
Menus
The BPM shows three different menus on the information display
depending on whether the BPM button is pressed once, twice or three
times. The menus change in sequence every time the BPM button is
pressed.
Figure 6:1
Figure 6:2
Information display, BPM, the first menu with previously measured values
6:4
HCEN9794 Revision.08.2003
Program version 10.xx
Figure 6:3
Figure 6:4
HCEN9794 Revision.08.2003
Program version 10.xx
6:5
Alarms
A BPM alarm is generated when a measured value is outside the set
alarm limits.
The BPM button and the MUTE button will flash and there will be a
soft buzzer signal. The measured values outside the set alarm limits
will flash on the information display.
Press the MUTE button (which will light up) in order to mute the
buzzer and/or press the BPM button in order to confirm the alarm.
Alarm limits can be adjusted at any time during treatment by the
operator. It is also possible for a technician responsible to preset the
alarm limits.
The alarm function can be turned to on or off 1 by pressing the BPM
button twice to reach the second menu, followed by using the Select
arrow button and the Set knob.
To set alarm limits:
1. Press the BPM button three times in order to reach the third menu.
2. Press the Select arrow button; SET ALARMS will flash.
3. Turn the Set knob clockwise step by step and four different displays
are shown.
4. Choose desired display, SYSTOLIC, DIASTOLIC, MEAN
PRESSURE or PULSE.
Figure 6:5
Information display, BPM, alarm limits set for systolic blood pressure
5. Press the Select arrow button to choose LOW or HIGH alarm limit,
selected alternative will flash.
6. Set a proper alarm limit by using the Set knob.
7. When the alarm limit(s) has been (have been) set, step out by
pressing the Hold button three times.
8. If more alarm limits are to be set, restart the procedure from
position 1.
Alarm ranges that can be set by the operator: 2
Systolic blood
Diastolic blood
Mean blood
pressure
pressure
pressure
100150
60100
75115
40150
100150
60100
75115
40150
1
2
6:6
Pulse rate
Can be preset
Wider ranges can be preset by technician responsible
AK 95 S Operators manual - BPM
HCEN9794 Revision.08.2003
Program version 10.xx
Modes
The BPM can be used in three different modes; manual (MANUAL),
automatic (AUTO) and continuous (CONT). The BPM can also be set
to off (OFF) by entering MODE.
To set a mode:
1. Press the BPM button twice and the second menu will be displayed;
START/STOP will flash.
2. Press the Select arrow button once; MODE will flash.
3. Turn the Set knob clockwise until desired mode is shown; the
mode is activated.
HCEN9794 Revision.08.2003
Program version 10.xx
6:7
Figure 6:6
6:8
Can be preset
AK 95 S Operators manual - BPM
HCEN9794 Revision.08.2003
Program version 10.xx
Figure 6:7
checks
4
HCEN9794 Revision.08.2003
Program version 10.xx
Can be preset
AK 95 S Operators manual - BPM
6:9
6:10
HCEN9794 Revision.08.2003
Program version 10.xx
Figure 6:8
5
HCEN9794 Revision.08.2003
Program version 10.xx
Can be preset
AK 95 S Operators manual - BPM
6:11
NOTE
1. It is always possible to interrupt a blood pressure measurement
check in progress, in any mode, by turning the Set knob
anticlockwise when START/STOP flashes in the second menu.
2. After treatment, when the cuff is removed from the patient,
the blood pressure measurement will continue as set when
automatic or continuous mode is chosen. Manual mode or Off
has to be chosen to stop measurement. In order to keep the
five previously performed measurement values, manual mode
has to be chosen.
6:12
HCEN9794 Revision.08.2003
Program version 10.xx
BPM Off
In this mode it is possible to turn the BPM to off.
To set the BPM to off:
1. Press the BPM button twice; the second menu will be displayed
and START/STOP will flash.
2. Press the Select arrow button once; MODE will flash.
3. Turn the Set knob until OFF is shown and the blood pressure
monitor is turned off.
NOTE
Previously measured values (see Information storage in this
chapter) will be deleted 10 seconds after the BPM has been
turned to off. In order to keep the values; set the BPM in
manual (MANUAL) mode and the values will be stored until
the machine is switched off.
HCEN9794 Revision.08.2003
Program version 10.xx
6:13
6:14
HCEN9794 Revision.08.2003
Program version 10.xx
Chapter 7
Disinfection and cleaning, Auto
heat, Auto rinse
Disinfection - general . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Heat disinfection and Decalcification . . . . . . . . . . . . . . . . . . . . . . . . .
Performing heat disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Properties of different disinfection, decalcification and cleaning agents
Chemical disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Automatic start of heat disinfection or rinsing program . . . . . . . . . . . .
Chemical disinfection procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Residual test after chemical disinfection . . . . . . . . . . . . . . . . . . . .
Cleaning - general . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Calcium carbonate precipitates . . . . . . . . . . . . . . . . . . . . . . . . . . .
Organic fouling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Iron fouling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
General guidelines for maintenance of the flow path . . . . . . . . . . .
Central disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Performing central disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . .
Rinse/Drain procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Rinse/Drain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
External cleaning of the machine . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Chemical disinfectants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Solutions based on peracetic acid . . . . . . . . . . . . . . . . . . . . . . . . . .
Sodium hypochlorite . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other disinfectants based on sodium hypochlorite . . . . . . . . . . . . .
Formaldehyde . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Exchange of ultrafilter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
HCEN9794 Revision.08.2003
Program version 10.xx
7:2
7:4
7:5
7:7
7:8
7:10
7:12
7:13
7:15
7:15
7:15
7:15
7:16
7:17
7:17
7:18
7:18
7:19
7:21
7:21
7:22
7:22
7:22
7:23
7:1
Disinfection - general
The microbiological quality of the dialysis fluid depends on several
factors, such as:
The arrangement of the drain tube from the dialysis machine. The
drain tube must not be inserted into the drain receptacle, there must
be a sufficient air gap to avoid back-contamination from the sewer.
7:2
HCEN9794 Revision.08.2003
Program version 10.xx
NOTE
An attention alarm appears when the machine is started if more
than 5 days 1 have passed since the last complete disinfection.
It is still possible to perform a treatment and the attention
light will switch off as soon as the priming button is pressed.
However, the attention alarm will appear again the next time
the machine is turned on, if a disinfection program has not been
completely carried out.
1
HCEN9794 Revision.08.2003
Program version 10.xx
Can be preset
7:3
7:4
Can be preset
HCEN9794 Revision.08.2003
Program version 10.xx
Can be preset
7:5
appears, open the upper latch and press the flashing Heat Disinf
button until it illuminates. The CleanCart cartridge will now be
emptied. When the CleanCart is empty remove it and close the
latches.
3. If an automatic switch off is required, press the ON/OFF button
for 3 seconds.
4. When the heat disinfection program is completed and the machine
has been drained the Rinse/Drain button starts to flash.
If a new treatment is to be started, press the Reset or Rinse/Drain
button to start a new function check.
NOTE
1. The pick-up tubes must be disinfected and rinsed separately.
2. All the programs can be interrupted at any time by pressing the
Rinse/Drain button. The machine will then continue with a drain
sequence. (If chemicals have been used, a rinse and a drain.)
7:6
HCEN9794 Revision.08.2003
Program version 10.xx
Efficiency
Efficiency of
on inorganic
on organic
disinfection
precipitates
precipitates
Calcium
Iron
oxide
High
Low
Low
High
None
None
High
High
Low4
None
None
High
High
Low
Low
High
None
None
High
High
Formaldehyde 4 %
None
None
None
High
Glutardialdehyde 2 %
None
None
None
High
Low
High
None
High
7:7
Chemical disinfection
CAUTION
Disinfectants may be toxic. The user therefore must take note
of necessary precautions before use. The manufacturer's
instructions and recommendations have to be followed.
Automatic dilution:
1+34
Consumption:
Contact time:
10 min
minimum 3 h
Total time:
Hypochlorite
7:8
Disinfectant:
Automatic dilution:
1+19
Consumption:
Contact time:
10 min
not applicable
Total time:
HCEN9794 Revision.08.2003
Program version 10.xx
Formal*
Disinfectant:
Formaldehyde 37 %
Automatic dilution:
1+9
Consumption:
Contact time:
20 min 6
minimum 6 h
Total time:
6
HCEN9794 Revision.08.2003
Program version 10.xx
Can be preset
7:9
HCEN9794 Revision.08.2003
Program version 10.xx
4. Select the next day (RDY DAY) by using the Select arrow button
and the Set knob .
5. Select the ready time (RDY TIME) or the OFF function (see
above) for that day. Proceed according to the above instructions
until a complete weekly program has been set.
6. Activate the function by pressing the Auto Heat or Auto Rinse
button for 3 seconds (the button lights up).
NOTE
The buttons must also be pressed for 3 seconds (the light of
the button goes out) in order to deactivate the function.
HCEN9794 Revision.08.2003
Program version 10.xx
7:11
CAUTION
Disinfectants may be toxic. The user must therefore take
necessary precautions before use. Follow the instructions and
recommendations from the manufacturer of the disinfectant.
7:12
Can be preset
HCEN9794 Revision.08.2003
Program version 10.xx
NOTE
1. The pick-up tubes must be disinfected and rinsed separately.
2. If the machine is left filled with a disinfectant overnight (not
hypochlorite), the rinse program will start immediately after
power on.
Press the Rinse/Drain button for 3 seconds (the button lights up)
and start a new rinse/drain procedure. When this is finished, repeat
the handling procedure described above.
HCEN9794 Revision.08.2003
Program version 10.xx
7:13
CAUTION
The operator has to verify after the disinfection procedure or
prior to the dialysis treatment that there are no residuals from
the chemical disinfectants in the machine or in the dialysis fluid.
The test has to be performed according to the recommendation
given by the manufacturer of the disinfection solution.
NOTE
The AK 95 S:s pick-up tubes must be disinfected and rinsed
separately.
7:14
HCEN9794 Revision.08.2003
Program version 10.xx
Cleaning - general
NOTE
Periodic maintenance of the AK 95 S must be performed. See
the AK 95/AK95 S Maintenance Manual HCEN9137.
Organic fouling
Organic substances, e.g. proteins and glucose, contaminate the
measuring electrodes of the ultrafiltration control system, resulting in
an increased frequency of technical errors.
WARNING
DO NOT mix sodium hypochlorite with acid solutions such
as citric, acetic, oxalic or peracetic acid as this will produce
hazardous fumes (chlorine). Always make sure that a complete
rinse cycle is performed between consecutive cleaning
procedures.
Iron fouling
Iron in the incoming water will coat the measuring electrodes of the
ultrafiltration control system with iron oxides (rust), resulting in an
increased frequency of technical errors. Iron oxides are effectively
removed by a 2 % solution of oxalic acid.
HCEN9794 Revision.08.2003
Program version 10.xx
7:15
NOTE
1. Improper cleaning of the UF-cell may be a contributing factor
for increased inaccuracy of the UF system. The use of
CleanCart-A in AK 95 S may have limited cleaning effect due
to the short contact phase in the cleaning program. If any
deviations in UF accuracy should occur, it is recommended to
use a more frequent cleaning with CleanCart-A or use sodium
hypochlorite instead.
2. In order to enable the cleaning agents to remove fats, proteins
etc. efficiently, the cleaning is recommended to be carried out
after decalcification.
7:16
HCEN9794 Revision.08.2003
Program version 10.xx
Central disinfection
AK 95 S can be programmed to perform central chemical disinfection8.
In this mode, the machine is receiving disinfection solution through
the central water supply system. The central disinfection program in
AK 95 S performs a continuous rinse through the fluid monitor until
a preset time has passed or the operator has activated the rinse/drain
function.
8
HCEN9794 Revision.08.2003
Program version 10.xx
Can be preset
7:17
Rinse/Drain procedure
The dialysis fluid tubes must be connected to the safety couplings and
the concentrate connectors must be in the couplings of the mixing unit.
Rinse/Drain
1. Press the Rinse/Drain button for more than 3 seconds to start the
rinsing and draining function (10 min).
If the button is pressed a second time for more than 3 seconds an
immediate drain starts (4 min).
NOTE
In order to change the rinse time, press the Rinse/Drain button
briefly and change it directly by the Set knob . The temperature
can be changed by preset.
7:18
HCEN9794 Revision.08.2003
Program version 10.xx
HCEN9794 Revision.08.2003
Program version 10.xx
7:19
The following procedure shown below is the procedure for taking the
rubber bladder out of the cloth bag.
In the cloth bag are holes for the rubber bladder and the rubber hose.
The large hole is used to put the rubber bladder through and the small
hole is used to put the rubber hose through. Figure A.
Put the rubber hose inside and pull out the inside cloth to make the
hole larger. Figure B and C.
Take the rubber bag out of the larger hole. Figure D.
Figure 7:1 BPM cuff, removal procedure of rubber bladder from cloth bag
1. Small hole
2. Large hole
Reverse the order when putting the rubber bladder in the cloth bag.
When the cloth bag of the cuff is removed, pay attention to the hole
through which the rubber hose of the rubber bladder goes. Unless the
hole is used, the rubber bag gets out of the cloth bag, leading to blow
out.
7:20
HCEN9794 Revision.08.2003
Program version 10.xx
Chemical disinfectants
Chemical disinfectants may be harmful to the materials used in the fluid
path of dialysis machines. Disinfectants may also contain additives
that cause foaming or are difficult to rinse out. The disinfectants listed
below are examples of chemicals recommended technically for use
in the AK 95 S, i.e. compatible with the materials in the machine,
provided that they are used in accordance with the recommendations
below. The efficiency of the disinfectant from a microbiological
standpoint must, however, be validated by the manufacturer of the
disinfectant and checked on a routine basis in the clinic.
CAUTION
The stated maximum dwell times below must be considered. A
longer dwell time may damage interior parts in the fluid path
and may cause a machine malfunction.
HCEN9794 Revision.08.2003
Program version 10.xx
7:21
Sodium hypochlorite
Active ingredients:
Approved concentration:
Mixing instructions:
Dwell time:
Test for residuals:
Sodium hypochlorite.
Weekly use: 0.5 % available chlorine.
Set the mixing ratios according to the
table below. Note that available chlorine
is approximately 70 % of the sodium
hypochlorite concentration. The table
below shows how to set different mixing
ratios for some concentrated sodium
hypochlorite solutions to obtain a 0.5 %
solution.
Maximum 20 minutes. Not intended for
overnight disinfection!
Chlorine Test Kits (e.g. Hach or Merck).
Concentrated solutions
Mixing ratio
ml
380
1 + 9
10
190
1 + 19
Formaldehyde
Active ingredient:
Formaldehyde.
Approved concentration : 4 %.
Mixing instructions:
Use 410 ml of a 37 % formaldehyde
solution (formalin) and set the mixing
ratio to 1+9.
Dwell time:
Unlimited.
Test for residuals:
e.g Formalert or Aquamerck 8028.
7:22
HCEN9794 Revision.08.2003
Program version 10.xx
Exchange of ultrafilter
NOTE
Make sure that the ultrafilters are exchanged in an aseptic way.
1. Release the lower part of the ultrafilter holder by pulling the handle
and pressing the latch downwards.
2. Remove the ultrafilter by pulling it gently downwards.
3. Insert the new ultrafilter into the holder and push it gently upwards.
4. Close the holder by pushing the lower latch into position.
5. Label the ultrafilter with date for exchange.
6. Perform a disinfection procedure before the AK 95 S is used for
treatment.
NOTE
The U 8000 S filter used in Ultra Filtered Dialysis Fluid kit is
to be exchanged regularly depending on the primary fluid
quality and the desired final fluid quality. The results from
microbiological controls have to determine the frequency of
exchange. A frequency between once a month and once every
three months can be expected.
HCEN9794 Revision.08.2003
Program version 10.xx
7:23
7:24
Revision.08.2003
AK 95 S Operators manual - Disinfection and cleaning, Auto heat, Auto rinse HCEN9794
Program version 10.xx
Chapter 8
Technical data and specifications
Performance and specification - Control system . . . . . . . . . . . . . . . . .
Blood flow control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Heparin administration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Blood pressure control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Blood Pressure Monitor (BPM) . . . . . . . . . . . . . . . . . . . . . . . . . . .
Dialysis fluid preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Ultrafiltration control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Disinfection and cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Water supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Power supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Connection of external equipment . . . . . . . . . . . . . . . . . . . . . . . . .
Performance and specification - Supervisory system . . . . . . . . . . . . .
Blood pressure supervision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Extracorporeal blood loss to the environment . . . . . . . . . . . . . . . .
Air detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Extracorporeal blood loss due to coagulation . . . . . . . . . . . . . . . . .
Dialysis fluid preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Ultrafiltration supervision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Blood leakage detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
pH-meter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Physical data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Dimensions and weight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Infusion stand . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Materials in contact with dialysate, concentrates and water . . . . . . . .
Environmental data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
HCEN9794 Revision.08.2003
Program version 10.xx
8:2
8:2
8:2
8:3
8:3
8:3
8:5
8:5
8:7
8:8
8:9
8:10
8:10
8:10
8:10
8:10
8:10
8:11
8:11
8:11
8:12
8:12
8:12
8:13
8:14
8:14
8:15
8:16
8:1
Flow accuracy:
10 ml/min or 15 %, whichever is
largest
0 - 327 litres
Volume accuracy:
0.6 l
Single needle
Flow rate:
Flow accuracy:
10 ml/min or 18 %, whichever is
largest
Time control 2:
Pressure control:
0 to 327 litres
Volume accuracy:
0.6 l
Values for the blood pump(s) are based on a pressure of -150 mmHg before the
arterial blood pump with a pump segment of 7,9 mm. For pediatric blood tubes
with pump segment of 4.0 mm it is also possible to set blood flow to 5, 10 or 15
ml/min.
2 The
actual clamp opening time is depending on blood flow rate, size of expansion
chamber and pressure limits.
Heparin administration
8:2
Heparinization:
Syringe size:
Stop time:
Counter pressure:
0 to 999.9 ml
HCEN9794 Revision.08.2003
Program version 10.xx
Alarm limits:
Accuracy:
60 - 250 mmHg
40 - 220 mmHg
45 - 235 mmHg
3Meets
HCEN9794 Revision.08.2003
Program version 10.xx
After pressure
regulator PR
1and the heat
exchangers:
After pressure
regulator PR2:
130 10 mmHg
Temperature 4:
Adjustable 33 to 40 C
Alarm limits:
Adjustable 33 to 40 C
8:3
Accuracy:
Heater capacity:
Overheat protection:
8:4
Flow rate:
Accuracy:
Degassing:
Accuracy:
40 mmHg
Accuracy:
10 mmHg or 5 %
Proportioning of concentrates:
Acetate:
Bicarbonate:
Measuring range:
13 to 16 mS/cm
Alarm limits:
HCEN9794 Revision.08.2003
Program version 10.xx
Ultrafiltration control
Volume control:
UF volume:
Adjustable 0 to 10.00 l
UF coefficient:
Maximum 83 ml/h/mmHg
UF rate:
Time:
Volume
10 minutes
Total time
10 % available chlorine
Volume
10 minutes
Total time
HCEN9794 Revision.08.2003
Program version 10.xx
Concentration
37 % formaldehyde
Volume
20 min
8:5
Total time
Heat disinfection
One of three alternatives for heat disinfection can be selected. The second alternative is presetable for a combined heating program and the third is a CleanCart /
heating alternative. The default settings are as follows.
AK 95 S
With
UFD
installed
Without
UFD
Disinfection
programs
110 V
100 V
Heat
35
39
49
52
57
67
Heat CleanCart
48
54
63
Heat
33
37
47
50
55
65
Heat CleanCart
46
51
60
With UFD
installed
Without UFD
8:6
Disinfection
programs
110 V
100 V
Heat
31
35
45
Heat
CleanCart
43
49
58
Heat
31
35
45
Heat
CleanCart
43
48
58
HCEN9794 Revision.08.2003
Program version 10.xx
Temperature:
Note:
Rinse/Drain:
Rinse/Drain
10 minutes
Drain
4 minutes
Exterior cleaning:
NOTE
Total Time for Disinfection Programs are estimated and may vary.
Water supply
HCEN9794 Revision.08.2003
Program version 10.xx
Flow rate:
Inlet temperature:
Connector in/outlet:
Diameter 8 mm
Quality:
Drain:
<5 m
8:7
Power supply
8:8
Mains voltage:
Note:
Power consumption:
Cable length:
3m
Cable area:
External fuses:
Mains plug:
9 A (100V)11 A (110V) 20 A
(230V)
Note:
HCEN9794 Revision.08.2003
Program version 10.xx
External
equipment:
Extern alarm:
Max voltage:
24 V
AC or DC
Max current:
100 mA
AC or DC
15 V
DC
5.0 V
DC
-5.0 V
DC
Max output
current:
5 mA
DC
Typ current:
20 mA
DC
Max current:
50 mA
DC
RS-232C:
RS-422/Current
loop:
HCEN9794 Revision.08.2003
Program version 10.xx
8:9
Alarm limits:
Accuracy:
Arterial pressure:
Operating range
Alarm limits:
Accuracy:
Air detection
Detection method:
Diameter 22 mm
Sensitivity:
Alarm:
8:10
40 C (0.5 C)
HCEN9794 Revision.08.2003
Program version 10.xx
Overheat protection:
Conductivity:
Alarm limits:
Ultrafiltration supervision
TMP:
Alarm limits:
Accuracy:
Sensitivity:
pH-meter
HCEN9794 Revision.08.2003
Program version 10.xx
Measuring range:
Accuracy:
0.2 pH
Alarm limits:
5.0 to 9.0 pH
8:11
Physical data
Dimensions and weight
Width:
Depth:
Height:
Weight:
Infusion stand
Maximum total load:
8:12
2 kg
HCEN9794 Revision.08.2003
Program version 10.xx
Metals
Stainless steel SS2343
Stainless steel SS2353
Stainless steel SS2562
Titanium
Platinum
Others
Carbon
Ceramic, Steatite 221
Ceramic, Aluminium oxide (Al2O3)
Glass
HCEN9794 Revision.08.2003
Program version 10.xx
8:13
Environmental data
Operation
+18 to +35 C
15 to 85 % RH
-20 to +70 C
10 to 96 % RH
During transportation and storage the equipment has to be kept in its original
packing. If transportation or storage time is more than 15 weeks, the environmental
data relating to the operation has to be followed. The maximum ambient
temperature for transportation and storage in 96 % Relative humidity is +40 C.
8:14
HCEN9794 Revision.08.2003
Program version 10.xx
Standards
The machine complies with the following standards:
IEC 60601-1 General requirements for safety, Class I, type B
IEC 60601-2-16 Particular requirements for safety of haemodialysis,
haemodiafiltration and haemofiltration equipment
IEC 60601-1-1 Safety requirements for medical electrical systems
IEC 60601-1-2 Electromagnetic compatibility
EN 1060-1 Non-invasive sphygmomanometers Part 1: General
requirements
EN 1060-1 Non-invasive sphygmomanometers Part 3: Supplementary
requirements for electromechanical blood pressure measuring systems
HCEN9794 Revision.08.2003
Program version 10.xx
8:15
References
Assembly Drawing K23000
8:16
HCEN9794 Revision.08.2003
Program version 10.xx
Chapter 9
Alarm lists
Alarm list . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9:2
Attention alarm list . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9:10
Technical alarm list . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9:41
HCEN9794 Revision.08.2003
Program version 10.xx
9:1
Alarm list
Light:
Steady
Mute time:
2 min
Additional information:
Low limit:
Blood pump stops
Venous clamp closes
Minimum UF rate (when blood is detected)
When pressure is within limits again, the blood pump starts and the
venous clamp opens.
If the Venous pressure button is pressed for 3 seconds the low limit
alarm is overridden for 5 - 120 1seconds.
High limit:
Blood pump stops
Minimum UF rate (when blood is detected)
When pressure is within limits again, the blood pump starts and the
venous clamp opens
Possible cause:
Low alarm:
The blood line has separated from the filter.
The blood line has separated at the arterial or venous side of the access.
The blood position of the venous needle has changed.
Clotting before or in the filter.
High alarm:
The venous blood line is kinked or clamped.
The position of the venous needle has changed.
Clotting has occurred after the venous pressure measurement e.g. in
the blood line, in the venous drip chamber or in the needle.
Light:
Flashing
Mute time:
2 min
Additional information:
Alarm limits are too wide.
After 2 minutes an attention alarm appears.
Possible cause:
-
9:2
Can be preset
AK 95 S Operators manual - Alarm lists
HCEN9794 Revision.08.2003
Program version 10.xx
Light:
Steady
Mute time:
2 min
Additional information:
Possible cause:
The blood flow has been lower than the low alarm limit for more than
the preset time.
The blood pump has been left in stop position too long due to an alarm.
The operator has left the blood pump in stop position too long.
Light:
Steady
Mute time:
2 min
Additional information:
Possible cause:
The stroke volume during SN is lower than the set low alarm limit.
Light:
Steady
Mute time:
2 min
Additional information:
Dialysis fluid bypass.
When the temperature is within limits again, the fluid enters the
dialyzer automatically.
Possible cause:
Low alarm:
The machine has not yet stabilized the temperature after an interruption
of the water supply.
High alarm:
The temperature of the incoming water is too high.
The machine has not yet stabilized the temperature after the function
check.
HCEN9794 Revision.08.2003
Program version 10.xx
9:3
Light:
Steady
Mute time:
2 min
Additional information:
Dialysis fluid bypass
When the conductivity is within limits again, the fluid enters the filter
automatically
Possible cause:
Low alarm:
The concentrate container/BiCart cartridge is empty.
The concentrate has not been connected.
Incorrect concentrate has been connected.
The proper concentrate has not been selected on the display.
There is an interruption in the concentrate administration to the
machine e.g. the connector is not properly connected to the pick-up
tube, the concentrate line is kinked or occluded.
Air is drawn into the machine instead of concentrate.
The filter(s) of the concentrate(s) is/are clogged.
The content of the concentrate container does not correspond to the
specifications given.
High alarm:
Incorrect concentrate has been connected.
The proper concentrate has not been selected on the display.
The content of the concentrate container does not correspond to the
specifications given.
9:4
HCEN9794 Revision.08.2003
Program version 10.xx
Light:
Steady
Mute time:
2 min
Additional information:
Low limit
Blood pump stops
Venous clamp closes
Min. UF rate (when blood is detected)
When the pressure is within limits again, the blood pump starts and
the venous clamp opens.
If the Arterial pressure button is pressed for 3 seconds the low limit
and high alarms is overridden for 5 - 120 2 seconds.
High limit
Blood pump stops
Venous clamp closes
Min. UF rate (when blood is detected)
When pressure is within limits again, the blood pump starts and the
venous clamp opens
Possible cause:
Low alarm:
The position of the arterial needle has been changed.
The arterial blood line is kinked or clotted between the arterial access
and the arterial pressure measurement.
The set blood flow rate exceeds the blood flow that the arterial access
has possibility to deliver.
The position of the arterial needle has changed.
High alarm:
The blood line has separated at the arterial side of the access.
The position of the arterial needle has changed.
Air or infusion enters the arterial line between the arterial access and
the blood pump e.g. when a pre blood pump infusion is connected.
Light:
Flashing
Mute time:
2 min
Additional information:
Alarm limits are too wide.
After 2 minutes an attention also appears.
Possible cause:
-
2
HCEN9794 Revision.08.2003
Program version 10.xx
Can be preset
AK 95 S Operators manual - Alarm lists
9:5
Light:
Steady
Mute time:
2 min
Additional information:
The TMP is outside the preset limits
Possible cause:
Low alarm
The set value for the treatment time has been increased or the set value
for the UF volume has been decreased during treatment.
Venous pressure decreases during treatment.
Changes in the UF-control system that can cause reduced accuracy
in the weight loss of the patient.
High alarm
The set value for the treatment time has been decreased or the set value
for the UF volume has been increased.
Venous pressure increases during treatment.
Partly clogged dialyzer.
Changes in the UF-control system that can cause reduced accuracy
in the weight loss of the patient.
Light:
Flashing
Mute time:
2 min
Additional information:
Alarm limits are too wide
After 2 minutes an attention alarm appears.
Possible cause:
-
.....
......
.......
Light:
Steady
Mute time:
2 min
Additional information:
Possible cause:
The connection to the external computer system has been interrupted.
9:6
HCEN9794 Revision.08.2003
Program version 10.xx
Light:
Flashing
Mute time:
2 min
Additional information:
An attention appears simultaneously
Possible cause:
No UF volume has been set when the machine detects blood.
Light:
Steady
Mute time:
2 min
Additional information:
An attention appears simultaneously
Possible cause:
Calculated set UF rate is lower than minimum UF rate set value.
Light:
Steady
Mute time:
2 min
Additional information:
Blood pump stops
Arterial clamps closes.
Venous clamps closes.
If the Air detect button is pressed for 3 seconds the alarm is overridden
for 0 - 120 3 seconds.
Possible cause:
Blood line(s) not properly connected at e.g. the arterial needle
connection, the filter connection(s), the infusion port(s). Blood line(s)
or the filter not properly de-aired during priming.
An empty infusion container with air inlet is connected to the blood
line(s).
The arterial needle is dislocated.
3
HCEN9794 Revision.08.2003
Program version 10.xx
Can be preset
AK 95 S Operators manual - Alarm lists
9:7
Light:
Flashing
Mute time:
2 min
Additional information:
Appears after an Air detect alarm
Press the Air detect button to confirm
Possible cause:
Light:
Steady
Mute time:
2 min
Additional information:
The pH is outside the limits
Possible cause:
The content of the concentrate container does not correspond to the
specifications given.
Incorrect concentrate has been connected.
Either the acid container or the bicarbonate container/BiCart cartridge
has been emptied during bicarbonate treatment.
Light:
Steady
Mute time:
2 min
Additional information:
Blood pump stops
Arterial clamps closes.
UF rate decreases and the dialysis fluid is bypassed.
If the Blood leak button is pressed for 3 seconds the alarm actions are
overridden for 5 -120 4seconds.
After treatment when the priming detector does not detect blood, the
blood leak alarm is delayed 30 seconds
Possible cause:
A leakage, which allows blood to flow from the blood compartment to
the dialysis fluid compartment, has occurred. Air bubbles or particles,
which can cause a false blood leak alarm, have entered the blood leak
detector.
9:8
Can be preset
AK 95 S Operators manual - Alarm lists
HCEN9794 Revision.08.2003
Program version 10.xx
Light:
Flashing
Mute time:
2 min
Additional information:
Appears after a Blood leak alarm.
Press the Blood leak button to confirm
Possible cause:
Light:
Flashing
Mute time:
Infinite
Additional information:
The systolic, diastolic or mean blood pressure or the pulse rate is
outside the alarm limits set.
Possible cause:
Light:
Flashing
Mute time:
2 min
Additional information:
An attention appears simultaneously
Possible cause:
The heparin rate has been set to zero when the machine detects blood.
Light:
Flashing
Mute time:
Infinite
Additional information:
An attention appears simultaneously
Possible cause:
Treatment time has expired.
HCEN9794 Revision.08.2003
Program version 10.xx
9:9
9:10
HCEN9794 Revision.08.2003
Program version 10.xx
AIR LEAKAGE
Check fluid tubes connections
Mute time:
2 min
Additional information:
Buzzer is delayed 2 min.
Appears when dialysate tubes are not properly connected to filter and
priming detector detects blood
CAUTION
Incorrect weight loss may occur if the machine is left for a
longer period with this attention.
Buzzer sound:
Soft buzzer
AUTO PRIMING
Waiting for dialysis fluid
Mute time:
Additional information:
Appears during autopriming, press the Fluid bypass button.
Buzzer sound:
No buzzer
HCEN9794 Revision.08.2003
Program version 10.xx
9:11
BATTERY FAILURE
Change battery or press SELECT
Mute time:
Infinite
Additional information:
Press the Select arrow button to confirm the information. The attention
alarm appears in Fch and also after treatment, when blood is no longer
sensed, as a reminder.
The alarm is to let the operator know that change or recharge of the
battery is needed. If the attention is confirmed without change or
recharge of the battery the machine will not be able to alarm or restart
in case of power failure.
The attention can be confirmed for three succeeding treatments. The
fourth time the battery failure occurs a technical error is generated and
the battery must be changed or recharged.
Buzzer sound:
Soft buzzer (in F.Ch) No buzzer (in disinf.)
BiCart emptied
press SELECT to confirm
Mute time:
Additional information:
Appears when the emptying of the BiCart is completed.
Buzzer sound:
No buzzer
9:12
HCEN9794 Revision.08.2003
Program version 10.xx
HCEN9794 Revision.08.2003
Program version 10.xx
9:13
9:14
HCEN9794 Revision.08.2003
Program version 10.xx
HCEN9794 Revision.08.2003
Program version 10.xx
9:15
BPM FAILURE
Turn off BPM
Mute time:
Infinite
Additional information:
An error is detected by the BPM. Turn the BPM off and then on again.
Buzzer sound:
Soft buzzer
9:16
HCEN9794 Revision.08.2003
Program version 10.xx
HCEN9794 Revision.08.2003
Program version 10.xx
9:17
9:18
HCEN9794 Revision.08.2003
Program version 10.xx
CLEANING REQUIRED
xx hours since last cleaning
Mute time:
Infinite
Additional information:
Will disappear as soon as priming is activated.
Buzzer sound:
Soft buzzer
DECALCIFICATION REQUIRED
XX hours since last decalcific.
Mute time:
Infinite
Additional information:
Will disappear as soon as priming is activated.
Buzzer sound:
Supersoft buzzer
HCEN9794 Revision.08.2003
Program version 10.xx
9:19
9:20
HCEN9794 Revision.08.2003
Program version 10.xx
DISINFECTION REQUIRED
xx days since last disinfection
Mute time:
Infinite
Additional information:
Will disappear as soon as priming is activated.
Buzzer sound:
Supersoft buzzer
HCEN9794 Revision.08.2003
Program version 10.xx
9:21
9:22
HCEN9794 Revision.08.2003
Program version 10.xx
HCEN9794 Revision.08.2003
Program version 10.xx
9:23
9:24
HCEN9794 Revision.08.2003
Program version 10.xx
HCEN9794 Revision.08.2003
Program version 10.xx
9:25
9:26
HCEN9794 Revision.08.2003
Program version 10.xx
HCEN9794 Revision.08.2003
Program version 10.xx
9:27
INCORRECT CONCENTRATE
Check concentrate
Mute time:
2 min
Additional information:
Buzzer sound:
Soft buzzer
9:28
HCEN9794 Revision.08.2003
Program version 10.xx
HCEN9794 Revision.08.2003
Program version 10.xx
9:29
NEGATIVE UF RATE
Check and press UF volume
Mute time:
2 min
Additional information:
Relative negative UF volume of 500 ml or negative UF rate >50
ml/min for 5 min. Check for "blockage" of the draining tube. After
correction of the fault, press the UF volume button for 3 sec. for
confirmation. Check the UF rate before leaving the machine, if this is
not correct call for technical service.
CAUTION
Incorrect weight loss may occur if confirmation is done without
having corrected the cause for the attention.
Buzzer sound:
Soft buzzer
NO BACKFILTRATION WARNING
Press TMP to confirm
Mute time:
2 min
Additional information:
The TMP alarm limits are set below zero mmHg and no backfiltration
warning will occur. This attention needs confirmation.
This attention can be removed by preset.
Buzzer sound:
Soft buzzer
9:30
HCEN9794 Revision.08.2003
Program version 10.xx
NO BPM VALUES
Check BPM cuff
Mute time:
Infinite
Additional information:
Buzzer delayed 2 min.
It was not possible to measure the patient's blood pressure. Check that
the cuff is correctly applied to the patient. It could also be that the
patient is moving during the measurement check.
Buzzer sound:
Soft buzzer
NO CUFF ATTACHED
Attach or check BPM cuff
Mute time:
Infinite
Additional information:
Buzzer delayed 2 min.
Check for kinks or leakage from the cuff and the cuff hose. Check also
that the cuff hose is properly connected to the machine.
Buzzer sound:
Soft buzzer
HCEN9794 Revision.08.2003
Program version 10.xx
9:31
9:32
HCEN9794 Revision.08.2003
Program version 10.xx
HCEN9794 Revision.08.2003
Program version 10.xx
9:33
9:34
HCEN9794 Revision.08.2003
Program version 10.xx
HCEN9794 Revision.08.2003
Program version 10.xx
9:35
9:36
HCEN9794 Revision.08.2003
Program version 10.xx
HCEN9794 Revision.08.2003
Program version 10.xx
9:37
9:38
HCEN9794 Revision.08.2003
Program version 10.xx
HCEN9794 Revision.08.2003
Program version 10.xx
9:39
9:40
HCEN9794 Revision.08.2003
Program version 10.xx
HCEN9794 Revision.08.2003
Program version 10.xx
9:41
9:42
HCEN9794 Revision.08.2003
Program version 10.xx
Chapter 10
Major changes
Major changes in operators manual from program version 9.xx to
10.xx . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Complete manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Chapter 1 and 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Chapter 6 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Chapter 7 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Chapter 9 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
The minual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
HCEN9794 Revision.08.2003
Program version 10.xx
10:2
10:2
10:2
10:2
10:2
10:2
10:2
10:1
Chapter 1 and 2
The machine is provided with a connector for potential equalization to
minimize the risk of electric shock when using central venous catheters.
A Caution is added in the Caution list in General precautions before
use in chapter 1 and a new position is added in Blood unit in chapter
2.
Chapter 6
A new chapter is added ; BPM - Blood Pressure Monitor (option).
The chapter includes instructions how to use the BPM function of the
machine.
Chapter 7
Present time of the day can now be changed by the operator when
performing Automatic start of heat disinfection or rinsing program.
Chapter 9
There are three new attention alarms added in the attention alarm list
connected to the BPM function:
BPM FAILURE
Turn off BPM
and
NO BPM VALUES
Check BPM cuff
and
NO CUFF ATTACHED
Attach or check BPM cuff
The minual
is removed from the manual for the time being.
10:2
HCEN9794 Revision.08.2003
Program version 10.xx
Chapter 11
Index
HCEN9794 Revision.08.2003
Program version 10.xx
11:1
A
Acetate . . . . . . . . . . . . . . . 3:25
Acetate button . . . . . . . . . . . 3:7
Acetoper . . . . . . . . . . . . . . 7:21
Actril . . . . . . . . . . . . . . . . . 7:21
Air detector . . . . . . . . . . . . . 2:2
Alarm function of the parameter
buttons . . . . . . . . . . . . . . . 3:16
Alarm indicators . . . . . . . . 3:15
Alarm list . . . . . . . . . . . . . . 9:2
Alarms . . . . . . . . . . . . . . . . 3:15
Amuchina . . . . . . . . . . . . . 7:22
Appliance inlet . . . . . . . . . . 2:8
Aquamerck . . . . . . . . . . . . 7:22
Arterial and venous line
clamps . . . . . . . . . . . . . . . . 2:3
Arterial blood line . . . . . . . . 4:6
Arterial line guide . . . . . . . . 2:3
Arterial pressure alarm . . . 3:16
Arterial pressure transducer
connector . . . . . . . . . . . . . . 2:3
Attaching the filter and the blood
lines . . . . . . . . . . . . . . . . . . 4:5
Attention alarm list . . . . . . 9:10
Auto Heat button . . . . . . . . . 3:6
Auto Rinse button . . . . . . . . 3:6
B
Bargraph display . . . . . . . . . 3:4
Bars, lifting positions . . . . . 2:6
Bicarbonate . . . . . . . . . . . . 3:25
Bicarbonate button . . . . . . . 3:7
BiCart holder . . . . . . . . . . . . 2:6
Blood flow . . . . . . . . . . . . 3:25
Blood flow knob . . . . . 3:5, 3:22
Blood leak detector . . . . . . . 2:4
Blood path . . . . . . . . . . . . . . 3:8
Blood pressure measurement
accessories . . . . . . . . . . . . 1:12
Blood pump . . . . . . . . . 2:3, 3:19
Blood pump alarm . . . . . . . 3:16
Blood unit . . . . . . . . . . . . . . 2:2
Blue concentrate connector with
white tube marking . . . . . . 2:7
BPM - Blood Pressure Monitor
Handling instructions . . . 6:1
BPM - five minutes
measuring . . . . . . . . . . . . 6:11
BPM - interval measuring . . 6:9
BPM - single measuring . . . 6:8
BPM alarms . . . . . . . . . . . . 6:6
BPM connection . . . . . . . . . 2:3
BPM cuff . . . . . . . . . . . . . . . 6:2
BPM information storage . . 6:4
BPM menus . . . . . . . . . . . . . 6:4
C
Caution . . . . . . . . . . . . . . . . 1:2
CE-marking . . . . . . . . . . . . 1:15
Central disinfection . . . . . . 7:17
Centralizing alarm . . . . . . . 3:16
Change of blood pump
segments . . . . . . . . . . . . . 3:31
Chemical disinfectants . . . 7:21
Chemical disinfection . 7:8, 3:25
Chemical disinfection
button . . . . . . . . . . . . . . . . 3:6
Chlorine Test Kits . . . . . . . 7:22
Cleaning - general . . . . . . . 7:15
Clinic Automation alarm . . 3:17
Concentrates . . . . . . . . . . . 1:10
Conductivity . . . . . . . . . . . 3:26
Conductivity alarm . . . . . . 3:16
control system . . . . . . . . . . . 1:6
D
Definitions of expressions . . 1:2
Dialox . . . . . . . . . . . . . . . . 7:21
Dialysis fluid inlet (from
filter) . . . . . . . . . . . . . . . . . 2:4
Dialysis fluid outlet (to
filter) . . . . . . . . . . . . . . . . . 2:4
Discontinuing dialysis . . . . 4:24
Disinfection ports . . . . . . . . 2:7
Disinfection, and cleaning Auto
heat, Auto rinse . . . . . . . . . 7:1
Display and setting group . 3:21
double clamp function . . . . . 1:5
Drain . . . . . . . . . . . . . . . . . . 2:8
E
Exchange of ultrafilter . . . 7:23
Expansion chamber holder . 2:3
External cleaning of the
machine . . . . . . . . . . . . . . 7:19
F
Filter . . . . . . . . . . . . . . . . . . 4:5
Filter holder . . . . . . . . . . . . . 2:3
Filter path . . . . . . . . . . . . . . 3:8
Filters . . . . . . . . . . . . . . . . 1:11
Flow diagram . . . . . . . . 3:4, 3:8
Fluid bypass button . . . . . . 3:20
Fluid unit . . . . . . . . . . . . . . . 2:4
Formaldehyde . . . . . . . . . . 7:22
Formalert . . . . . . . . . . . . . . 7:22
Fuses . . . . . . . . . . . . . . . . . . 2:8
HCEN9794 Revision.08.2003
Program version 10.xx
G
General precautions before
use . . . . . . . . . . . . . . . . . . . 1:3
H
Hach . . . . . . . . . . . . . . . . . 7:22
Heat disinfection . . . . . . . . 3:25
Heat disinfection and
Decalcification . . . . . . . . . 7:4
Heat disinfection button . . . 3:6
Heparin pump . . . . . . . . . . . 2:3
Heparin pump alarm . . . . . 3:17
heparinization . . . . . . . . . . . 4:8
High venous pressure test . 4:14
Hydrogen peroxide . . . . . . 7:21
Hygiene group . . . . . . . . . . . 3:6
I
Information display . . . 3:5, 3:21
Infusion stand . . . . . . . . . . . 2:8
Initial procedures . . . . . . . . 4:2
Initiating dialysis . . . . . . . . 4:15
Intended use . . . . . . . . . . . . 1:5
Interface connection . . . . . . 2:8
Iodine starch test strips . . . 7:21
Isol UF button . . . . . . . . . . . 3:7
L
Level adjustment knob . . . . 2:3
Lines . . . . . . . . . . . . . . . . . 1:11
List of concentrates, accessories
and disposables . . . . . . . . 1:10
List of symbols . . . . . . . . . 1:13
M
Main switch . . . . . . . . . . . . . 2:8
Maranon H . . . . . . . . . . . . 7:22
Merck . . . . . . . . . . . . . . . . 7:22
Merckoquant 10011 . . . . . 7:21
Mode buttons and Parameter
buttons and their displays . 3:9
Mode group . . . . . . . . . . . . . 3:7
Mute . . . . . . . . . . . . . . . . . 3:20
N
Note . . . . . . . . . . . . . . . . . . . 1:2
O
ON/OFF button . . . . . . . . . . 3:6
Operator's panel . . . . . . 2:2, 3:4
Other disinfectants . . . . . . 7:22
Override . . . . . . . . . . . . . . 3:18
P
Peracetic acid . . . . . . . . . . 7:21
HCEN9794 Revision.08.2003
Program version 10.xx
Peresal . . . . . . . . . . . . . . . . 7:21
Potential equalization . . . . 2:3
1:4, 1:14
Power failure . . . . . . 3:29 3:30
Priming and rinsing . . . . . . 4:12
Priming detector . . . . . . . . . 2:3
protective system . . . . . . . . 1:6
Puristeril 340 . . . . . . . . . . . 7:21
R
recirculation in single-needle
treatment . . . . . . . . . . . . . 4:20
Recovery from power
failure . . . . . . . . . . . . . . . 3:29
Red concentrate connector . 2:6
Renalin . . . . . . . . . . . . . . . 7:21
Residual test . . . . . . . . . . . 7:13
Returning the blood . . . . . . 4:24
Rinse/Drain . . . . . . . . . . . . 3:25
Rinse/Drain button . . . . . . . 3:6
Rinse/Drain procedure . . . 7:18
S
Safety couplings . . . . . . . . . 2:4
Safety philosophy . . . . . . . . 1:6
Service frame . . . . . . . . . . . 2:6
Set knob . . . . . . . . . . . 3:5, 3:22
Setting of parameters . . . . 3:24
Single Fault Conditions . . . . 1:6
Single needle data . . . . . . . 3:25
Single needle data alarm . . 3:16
SN button . . . . . . . . . . . . . . 3:7
Sodium hypochlorite . . . . . 7:22
Soft pac hook . . . . . . . . . . . 2:3
Stand-by group . . . . . . . . . 3:19
Start the machine . . . . . . . . . 4:3
Start UF Stop . . . . . . . . . . . 3:20
T
Temperature . . . . . . . . . . . 3:25
Temperature alarm . . . . . . 3:16
The eight commandments . 3:23
Time . . . . . . . . . . . . . . . . . 3:26
Time attention alarm . . . . . 3:17
Time display . . . . . . . . . . . . 3:4
Top tray . . . . . . . . . . . . . . . . 2:2
Transmembrane pressure
alarm . . . . . . . . . . . . . . . . 3:16
Tray for concentrate
containers . . . . . . . . . . . . . 2:6
Treatment overview group . 3:8
U
UF rate alarm . . . . . . . . . . 3:17
UF volume . . . . . . . . . . . . 3:26
V
Venous blood line . . . . . . . 4:10
Venous pressure . . . . . . . . 3:25
Venous pressure alarm . . . 3:16
W
Warning . . . . . . . . . . . . . . . .
Water inlet . . . . . . . . . . . . . .
Water requirements . . . . . . .
Wheels . . . . . . . . . . . . . . . . .
1:2
2:8
1:8
2:6
HCEN9794 Revision.08.2003
Program version 10.xx