Instructions for use
Barkey Prismacomfort
blood heater for
Gambro Prismaflex®
Version
Issue
3 EN
2015-12-07
Sales by:
Gambro Lundia AB
Monitor Division
Box 10101
SE-220 10 Lund
Sweden
Manufactured by:
Barkey GmbH & Co. KG
Gewerbestrasse 8
33818 Leopoldshoehe
Germany
Contents
Instructions for use
Barkey Prismacomfort
Contents
1
2
3
Introduction ................................................................................................. 1
1.1
Important things to observe ..................................................................... 1
1.2
Pictograms, signal words and symbols .................................................. 2
1.3
Intended purpose ...................................................................................... 2
1.4
Target group.............................................................................................. 3
1.5
Contra-indications .................................................................................... 3
1.6
Disclaimer ................................................................................................. 3
1.7
Copyright ................................................................................................... 3
Fundamental product characteristics ....................................................... 4
2.1
The Barkey autocontrol 3XPT control unit .............................................. 5
2.2
The lug on the Barkey autocontrol 3XPT control unit ............................ 6
2.3
The Barkey autoline XPT 4R heater ......................................................... 7
2.4
Support for the Barkey autoline XPT 4R heater ...................................... 7
2.5
Device functions ....................................................................................... 8
2.6
Overtemperature protection..................................................................... 8
2.7
Safety features .......................................................................................... 9
2.8
Conformities.............................................................................................. 9
2.9
Further development ................................................................................ 9
Use for the intended purpose / safety instructions ............................... 10
3.1
Safety instructions for using the device ............................................... 11
3.2
Safety instructions on handling the device .......................................... 13
3.3
Safety instructions and environmental influences ............................... 14
3.4
Electromagnetic properties / safety distances ..................................... 15
3.4.1 Electromagnetic outputs ........................................................................... 15
3.4.2 Electromagnetic immunity ......................................................................... 16
3.4.3 Recommended safety distance ................................................................. 18
4
5
Controls and displays .............................................................................. 19
4.1
Operating panel ...................................................................................... 19
4.2
Symbols on labels .................................................................................. 20
4.3
Safety instructions sticker for Barkey autoline XPT 4R heater ........... 22
Setting up, getting started ....................................................................... 23
Instructions for use Barkey Prismacomfort - V3 EN - pc-100-EW-0005-02 - 2015-12-07
Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe - Germany - Switchboard: +49 (5202) 9801-0
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Instructions for use
Barkey Prismacomfort
Contents
5.1
Set-up location ........................................................................................ 23
5.2
Installation of the Barkey Prismacomfort.............................................. 23
5.2.1 Installing the control unit ........................................................................... 23
5.2.2 Installing the Barkey autoline XPT 4R heater support ............................... 25
5.2.3 Installing the cable guide for the Barkey autoline XPT 4R heater .............. 27
5.2.4 Installation of the Barkey autoline XPT 4R heater ..................................... 27
5.3
Connection of the Barkey autoline XPT 4R heater to the control unit 29
5.4
Positioning the Barkey autocontrol 3XPT control unit......................... 31
5.5
Inserting the blood return flow tube into the heater ............................. 33
5.6
Getting started ........................................................................................ 35
5.6.1 Connecting the Barkey autocontrol 3XPT control unit to the power supply 35
5.6.2 Switching on the Barkey autocontrol 3XPT control unit ............................. 35
6
Operation .................................................................................................. 36
6.1
Main screen ............................................................................................. 36
6.2
Menu structure ........................................................................................ 37
6.2.1 Temperature measurement ....................................................................... 38
6.2.2 Set value setting, channel 1 ...................................................................... 39
6.2.3 Set value setting, channel 2 ...................................................................... 40
6.2.4 Nighttime mode......................................................................................... 41
6.2.5 Language.................................................................................................. 41
6.2.6 System information ................................................................................... 42
6.2.7 Information channel 1 ............................................................................... 42
6.2.8 Information channel 2 ............................................................................... 43
7
Cleaning and care .................................................................................... 44
8
Maintenance ............................................................................................. 45
8.1
Technical safety inspection (TSI) .......................................................... 45
8.2
Replacing the battery ............................................................................. 46
9
Error messages ........................................................................................ 47
10
Warranty and disclaimer of liability ........................................................ 50
11
Customer Service ..................................................................................... 51
11.1
Service information ................................................................................ 53
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Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe - Germany - Switchboard: +49 (5202) 9801-0
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Contents
12
Instructions for use
Barkey Prismacomfort
Specifications ........................................................................................... 59
Appendix:
Prismacomfort master data sheet
Declaration of Conformity
Quality Management System Certificate
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Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe - Germany - Switchboard: +49 (5202) 9801-0
Customer service: +49 (5202) 9801-30 Fax: +49 (5202) 9801-99 - Email: info@barkey.de
Instructions for use
Barkey Prismacomfort
Introduction
1
Introduction
This user manual is intended as an introduction to the functions of the Barkey Prismacomfort blood heater for the Gambro Prismaflex haemodialysis system. It covers the
commissioning, use and maintenance of this unit.
1.1
Important things to observe
WARNING
Carefully read through this user manual before using the device.
It is imperative that you observe the information about correct use and the safety
instructions contained in Chapter 3 of this user manual. For a better understanding
of this chapter you should familiarise yourself with the basic functions of the device as described in Chapter 2.
You should also comply with the requirements for the training and skills of persons
using the device, as indicated in Chapter 1.4.
WARNING
Medical electrical devices are subject to particular precautionary measures with regard to EMC (electromagnetic compatibility). Please ensure that the device is installed and operated in accordance with the EMC guidelines contained in this user
manual.
You must follow the conditions of use and safety instructions contained in this user manual at all times when using the device. This will ensure that there is no improper handling
of the device which might put patients or users of the device at risk and result in damage
to the device.
Barkey GmbH & Co. KG accepts no liability for damage caused as a result of failure to
follow this user manual.
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Instructions for use
Barkey Prismacomfort
1.2
Introduction
Pictograms, signal words and symbols
This user manual uses the following pictograms and symbol words to highlight warnings
and special advice.
WARNING
If not observed: danger to people.
CAUTION
If not observed: danger to property,
the device or basic functions of the device.
NOTE
Additional helpful advice and information.
(The "i" stands for "information".)
You will find the following symbol in instructions about the use and maintenance of the
device:
Step contained in instructions.
Perform this step as indicated.
►
NOTE
The symbols representing the controls and device displays, and the symbols used
on device labels, are listed and described in Chapter 4 of this user manual.
1.3
Intended purpose
The Barkey Prismacomfort blood heater for the Gambro Prismaflex haemodialysis
system is a heater for use on the blood return flow tubes between the Gambro Prismaflex
haemodialysis system and the patient.
The device can be used with the Gambro Prismaflex haemodialysis system in all cases
where it is necessary to prevent the patient suffering a fall in temperature.
CAUTION
In the event of high rates of blood flow exchange with Prismaflex hemodialysis
apparatus, the patient may experience hypothermia despite use of the Barkey Prismacomfort blood warmer. If, in spite of using the Barkey Prismacomfort blood
warmer, the patient should experience hypothermia, additional measures must be
taken to stabilise the body temperature. In this case, Barkey recommends using active warming systems for the patient (e.g. thermal conductive or connective blankets) to provide additional warmth.
2
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Instructions for use
Barkey Prismacomfort
Introduction
1.4
Target group
This user manual is intended for use by:

medical specialists in hospitals who hold a recognised vocational qualification in
medicine,

and specialist medical technicians who hold an accepted vocational qualification as
an electrical device electronics engineer or equivalent training
WARNING
Only personnel who meet requirements may use and service the device.
1.5
Contra-indications
There are no known contra-indications in relation to heating the Gambro Prismaflex
blood return flow tube.
1.6
Disclaimer
The manufacturer and/or its subsidiary companies are liable for the safety, reliability and
performance of the system only if all operating procedures, calibrations and repairs are
carried out by suitably trained and qualified personnel; if all alterations to the device have
been approved in writing by the manufacturer and have been carried out by suitably
trained and qualified personnel; if the electrical installation within the treatment room
satisfies local regulations and, if applicable, IEC requirements; if the devices are used in
accordance with the published user manual (these documents).
1.7
Copyright
This user manual and all illustrations it contains are protected by copyright. Translation,
duplication, reprinting, extraction of images, reproduction using photographic technology
and storage and processing in electronic systems, even only as excerpts, or any alterations
shall require the written authorisation of Barkey GmbH & Co. KG. KG. Any further
usage which goes beyond using the contents described in connection with the product
purchased is not permitted.
Third party products, protected trademarks etc. are stated without reference to the
registration or copyright status as a matter of principle. Existing industrial property rights
and registered trademarks are explicitly acknowledged.
We reserve the right to make typographical errors, mistakes and modifications in the
interest of technical progress, or which are necessary due to changes in regulations.
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Instructions for use
Barkey Prismacomfort
2
Fundamental product characteristics
Fundamental product characteristics
Support for Barkey autoline XPT 4R
Prismaflex
Screws for
attaching the
support and
the plastic
clip for the
cable guide
Barkey autocontrol 3XPT control unit
Barkey autoline XPT 4R
Figure 1: Barkey Prismacomfort for Prismaflex
The Barkey Prismacomfort blood heater for the Gambro Prismaflex haemodialysis system consists of the following components:

the Barkey autocontrol 3XPT control unit

a support for mounting a Barkey autoline XPT 4R (heater profile for the blood return flow tube) on the Prismaflex haemodialysis system

two screws for attaching the support to the Prismaflex haemodialysis system

a plastic clip for the cable guide

a Barkey autoline XPT 4R heater with a diameter 6.55 mm and a length of 1.7 m
4
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Instructions for use
Barkey Prismacomfort
Fundamental product characteristics
2.1
The Barkey autocontrol 3XPT control unit
Operating
panel
Carrying
handle
Lug
Connections
for the heaters
Ventilation
grille
Connection
for an external
sensor
Front view
Rear view
Figure 2: Barkey autocontrol 3XPT control unit
The Barkey autocontrol 3XPT control unit is capable of controlling up two Barkey
autoline XPT 4R heaters to the pre-set value at the same time. The set value can be set
within the range +33 °C to +43 °C for each heater. The display shows the current
temperature of the heater.
Two connection sockets are provided on the front of the Barkey autocontrol 3XPT control
unit for connection of the heater profiles.
Access using the serial interface on the underside of the device is reserved for
communications devices approved by the manufacturer.
An ambient temperature sensor or a sensor for measuring temperatures can be connected
to the connection for an external sensor.
WARNING
External temperature sensors sold by Barkey are not medical electrical thermometers and therefore must not be used for medical measurements (such as the patient's
temperature).
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Instructions for use
Barkey Prismacomfort
2.2
Fundamental product characteristics
The lug on the Barkey autocontrol 3XPT control unit
Figure 3: Lug
The lug is for attaching the Barkey autocontrol 3XPT control unit to the Prismaflex
haemodialysis system. The lug is screwed to the bracket on the Prismaflex haemodialysis
system. The screws used must be those supplied with the bracket. The bracket must be
ordered from the Gambro sales office.
The end of the Barkey autoline XPT 4R heater can be secured to the two slots on the lug
when the heater is not in use. This avoids the risk that the heater interferes with the
Prismaflex haemodialysis system scales or is damaged or contaminated by contact with
the ground.
6
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Fundamental product characteristics
2.3
Instructions for use
Barkey Prismacomfort
The Barkey autoline XPT 4R heater
The purpose of the Barkey autoline XPT 4R heater is to heat the Prismaflex haemodialysis system blood return flow tube. It is designed to suit an infusion tube diameter of 6.55
mm.
Other heaters are available as an alternative to suit blood return flow tubes with smaller
outside diameters. These heaters are not part of the scope of supply and can be ordered as
required from Gambro sales offices (Gambro item no.: G99001901).
The lengths of the heaters match the tube lengths of the filter set.
CAUTION
When installing the Barkey autoline XPT 4R heater, take care it does not interfere
with the Prismaflex haemodialysis system scales.
Figure 4: Barkey autoline XPT 4R heater
2.4
Support for the Barkey autoline XPT 4R heater
Figure 5: Support for the Barkey autoline XPT 4R heater
The purpose of the support for the heater is to provide a mounting point for the Barkey
autoline XPT 4R heater. The lug is attached to the right side of the casing of the Gambro
Prismaflex haemodialysis system.
CAUTION
When installing the Barkey autoline XPT 4R heater, take care it does not interfere
with the Prismaflex haemodialysis system scales.
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Instructions for use
Barkey Prismacomfort
2.5
Fundamental product characteristics
Device functions
The Barkey Prismacomfort blood heater for the Gambro Prismaflex haemodialysis
system is an electronically controlled temperature regulation system for blood return flow
tubes with 6.55 mm diameter connected to the Prismaflex haemodialysis device. The heat
is transmitted to the blood return flow tube via a silicone profile with integral heaters.
The blood return flow tube to be heated is laid in the heater and completely enveloped by
it. This complete enveloping of the tube being heated ensures no heat is lost to the
environment. This means there is the maximum amount of heat transfer from the silicone
profile to the fluid which is to be heated.
The temperature of the heaters can be set within a range +33 °C to +43 °C.
The Barkey Prismacomfort blood heater operates entirely independently from the
Gambro Prismaflex haemodialysis system. There is no electrical connection between the
two systems.
2.6
Overtemperature protection
The Barkey autocontrol 3XPT control unit is equipped with separate overtemperature
protection for each channel. This operates by reference to the set value. This overtemperature protection value is defined as 1°C above the respective set value. After the system has been switched on or after connection of a heater this overtemperature protection
is at first set to the maximum value so as to avoid false alarms if the heaters had previously been heated. As soon as the actual temperature falls below the set value overtemperature protection is automatically initiated at a value 1°C above the set value.
Each heater incorporates a second overtemperature protection which is factory-set to a
value specific to the type of heater. For Barkey autoline XPT 4R this overtemperature
protection value is 45.5 °C ± 1.5 °C. A separate measurement sensor monitors the temperature in the heater on behalf of the second overtemperature protection. The overtemperature protection cutout function is implemented within the control unit as an independent circuit.
At soon as the temperature of one of the heaters reaches one of the two overtemperature
protection values, both channels are switched off automatically and the connected heaters
start to cool down. The fault indication on the control unit lights up and an acoustic signal
sounds. An error message is shown in the display. The error messages are identified by
numeric codes, which are listed in Chapter 9.
8
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Fundamental product characteristics
2.7
2.8
Instructions for use
Barkey Prismacomfort
Safety features

Safe and gentle heating conditions are ensured by a maximum temperature setting
of 43 °C plus dual-function overtemperature protection which switches the unit off
permanently in the event of overtemperature.

There are no additional disposable items that might cause changes in pressure of
the extracorporal blood circuit.

There are no additional disposable items that might cause incorrect connections.

The connected heaters are detected automatically.

Plain text displays in the local language.

Clearly arranged and labelled displays and controls.

Device is designed for continuous operation.

The plastic casting is corrosion-free and saves energy.
Conformities
Full particulars regarding conformity can be found in the attached declaration of
conformity.
2.9
Further development
The Barkey Prismacomfort is the result of continuous teamwork between scientists,
specialist experts, users and the Barkey GmbH & Co. KG. We reserve the right to make
printing errors, mistakes and revisions which serve technical progress, or which are
necessary due to changes in regulations.
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Instructions for use
Barkey Prismacomfort
3
Use for the intended purpose / safety instructions
Use for the intended purpose / safety instructions
The Barkey Prismacomfort blood heater for the Gambro Prismaflex haemodialysis
system is a heating system for use on the blood return flow tubes between the Gambro
Prismaflex haemodialysis system and the patient.
The system can be used with the Gambro Prismaflex haemodialysis system in all cases
where it is necessary to prevent the patient suffering a fall in temperature.
WARNING
If infusion solutions or medicaments are heated in the Barkey Prismacomfort you
must ensure that their efficacy is maintained during heating and that the heating is
approved by the manufacturer of the infusion solution.
The Barkey autoline XPT 4R heater is designed for a blood return flow tube diameter of
6.55 mm. Other diameters of blood return flow tubes used with the Prismaflex haemodialysis system will not be properly heated by this heater. Other heaters are available to suit
blood return flow tubes with smaller outside diameters. These heaters are not part of the
scope of supply and can be ordered as required from Gambro agencies.
The supports are designed exclusively for attachment to the Gambro Prismaflex haemodialysis system.
The Barkey Prismacomfort blood heater is designed for continuous operation. It must not
be set to a temperature higher than 37 °C if the flow velocity is less than 100 ml/h. It is
designed for use at ambient temperatures from 10 °C to 40 °C.
An additional external temperature sensor for measuring the ambient temperature or for
other non-diagnostic applications can be connected to the Barkey autocontrol 3XPT control unit.
Only those external temperature sensors approved by Barkey GmbH & Co. KG may be
used. These external temperature sensors are not medical electrical thermometers or
thermometers authorised for medical purposes.
These general statements on the intended use of the device are supplemented in this user
manual by individual descriptions of the application and of the handling of the device,
and by safety instructions. You will find these descriptions in Chapters 3 to 8 of this user
manual. Please use these chapters to find specific information about how to use the device
in individual cases.
10
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Use for the intended purpose / safety instructions
3.1
Instructions for use
Barkey Prismacomfort
Safety instructions for using the device
WARNING
Read this user manual thoroughly before using the heating
system.
Only use the system in accordance with the regulations as
described previously in this chapter and in accordance with the
processes described in this user manual.
The manufacturer can accept no liability for the safety of the
patient if the operating, maintenance and calibration
procedures for the system deviate from the procedures
described in this user manual or in the service manual. Persons
using the device must be properly trained and qualified.
If infusion solutions or medicaments are heated in the Barkey
Prismacomfort blood heater for Prismaflex, you must ensure
that their efficacy is maintained during heating and that the
heating is approved by the manufacturer of the infusion
solution.
The control unit may be attached to the Prismaflex
haemodialysis system bracket exclusively by means of the lug
on the back of Barkey autocontrol 3XPT control unit in
accordance with the instructions in this user manual.
The heater may be attached exclusively to the support for
heaters on the Prismaflex haemodialysis system in accordance
with the instructions in this user manual.
The Barkey Prismacomfort may be fitted and transported only
in the positions described in Chapter 5 of this user manual.
If the Barkey Prismacomfort is operated with accessories, these
must exclusively be those approved by Barkey GmbH & Co.
KG (see Chapter 2). The use of unapproved accessories can
lead to increased radiated electromagnetic emissions (EMI) or
reduce the device's immunity to electromagnetic interference.
The heater connection head must be securely inserted in the
holder provided for it!
Do not kink, cover, warm or cool the heater! Do not cover the
heaters with cloths or dressing materials, do not run it under
bedcovers, hot-air covers, etc., and do not expose it to direct
sunlight or thermal radiation. Only run the heater uncovered
through the air. Do not run it into or through incubators.
Do not shorten or damage the heater.
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Instructions for use
Barkey Prismacomfort
WARNING
Use for the intended purpose / safety instructions
If a malfunction alarm sounds during self-test it means the
device has failed the test. Do not use the system. Call a trained
qualified service technician.
The heaters and the electrical leads to the Barkey
Prismacomfort should be laid in accordance with this user
manual (Chap. 5) so as to ensure that there is no interference
with the haemodialysis system and in particular the scales.
If the overtemperature alarm sounds, the supply of liquids to
the patient must be stopped immediately.
If the haemodialysis system is brought to a stop and at the
same time the Barkey autoline XPT 4R heater starts to cool
down, the risk of overheating the liquid in the enveloped tubes
cannot be excluded.
If the flow velocity is less than 100 ml/h the Barkey
Prismacomfort blood heater must not be set higher than 37 °C.
External temperature sensors sold by Barkey GmbH & Co. KG
are not medical electrical thermometers and therefore must not
be used for measurements related to medical purposes (such as
the patient's temperature).
After being connected to the Barkey autocontrol 3XPT, a
heater must remain connected for at least 6 seconds.
Otherwise, the parameters saved in the heater cannot be
correctly recognised.
After disconnecting a heater from the Barkey autocontrol
3XPT, you must wait at least 6 seconds before connecting
another heater. Otherwise, the parameters saved in the heater
cannot be correctly recognised.
The system must not be used if the device has a fault. The
system must be checked by a trained and qualified service
technician.
12
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Use for the intended purpose / safety instructions
3.2
Instructions for use
Barkey Prismacomfort
Safety instructions on handling the device
WARNING
CAUTION
Before using the system, carefully read and familiarise yourself
with this manual and the user documentation for the optional
accessories.
All electrical installations must comply with the relevant
applicable regulations and standards, in addition to the
specifications stated by the manufacturer. The user is
responsible for correct installation.
Only the power supply connections supplied by Barkey GmbH
& Co. KG,
which are designed for the rated voltage of the device, may be
used.
The mains plug must be removed from the mains socket to
ensure safe isolation of the device from the power supply.
The system contains no parts which can be repaired by the
user. Do not carry out repairs to the system yourself. Please
contact the manufacturer or your medical technician service,
who can request information about overhauls from the
manufacturer if necessary. Repair work and device
modifications may only be carried out by Barkey GmbH & Co.
KG, representatives of the Gambro Renal Products sales
company or authorised personnel.
Clean and disinfect the heaters after each use.
Using cleaning products and disinfectants other than as
described in this user manual can damage the device. Check
with the manufacturer before using chemicals which are not
explicitly recommended for use on the system. In particular,
you are warned against the use of the following solutions:
 halogenated aromatic and aliphatic solvents;
 ketonic solvents.
A technical safety inspection (TSI) must be carried out
each year by qualified service personnel, representatives of the
Gambro Renal Products sales company or employees of
Barkey GmbH & Co. KG.
The battery (lithium battery
CR 1225, 3 V) must be replaced every three years by qualified
service personnel, representatives of the Gambro Renal
Products sales company or employees of Barkey GmbH & Co.
KG.
Repair work and device modifications may only be carried out
by qualified service personnel, representatives of Gambro
Renal Products sales company or employees of Barkey GmbH
& Co. KG.
Instructions for use Barkey Prismacomfort - V3 EN - pc-100-EW-0005-02 - 2015-12-07
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Instructions for use
Barkey Prismacomfort
3.3
Use for the intended purpose / safety instructions
Safety instructions and environmental influences
WARNING
The influence of strong electromagnetic fields (e.g. through the
use of HF therapy or surgical devices) can lead to malfunctions
in the system. If interference of this type occurs, increase the
distance between the Barkey Prismacomfort and the device
causing the interference, or operate the devices at separate
times. The Barkey Prismacomfort works perfectly within the
limit values set in the EN 60601-1-2 standard. The system can
be affected by interference that exceeds the limit values set by
the EN 60601-1-2 standard.
The Barkey Prismacomfort may not be used immediately next
to other devices or stacked on top of other devices. If it is
necessary to operate the device next to or stacked on top of
other devices, the Barkey Prismacomfort should be monitored
to check that it is working correctly in this situation.
Portable and mobile HF communication equipment such as
mobile phones can affect the system.
Do not use the device in the immediate vicinity of
 flammable materials (e.g. gases, liquids);
 flammable mixtures of anaesthetic substances with air;
 flammable mixtures of anaesthetic substances with oxygen
or laughing gas
whose flashpoint is below 50 °C. It is imperative that the
device is not used in areas in which alcoholic disinfectants and
anaesthetising substances are being used at the same time.
The system may not be set up or operated in the immediate
vicinity of devices with a high thermal discharge output.
At installation, ensure free circulation of air to the back and
underside of the control unit.
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Use for the intended purpose / safety instructions
3.4
Electromagnetic properties / safety distances
3.4.1
Electromagnetic outputs
Instructions for use
Barkey Prismacomfort
Guidelines and manufacturers declaration - Electromagnetic emission
The Barkey autocontrol 3XPT is suitable for operation in any of the environments listed
below. The customer or user of the Barkey autocontrol 3XPT must ensure that it is operated
in one of these environments.
Electromagnetic environment–
Radiated EMI measurements
Compliance
Guidelines
The Barkey autocontrol 3XPT
uses high-frequency energy for
internal functions only. This
HF outputs in accordance with
Group 1
means that HF emissions are
CISPR 11
very low, and neighbouring
electronic devices are unlikely to
be affected.
HF outputs in accordance with
Class B
The Barkey autocontrol 3XPT is
CISPR 11
suitable for use in buildings other
than residential and those which
Harmonic output in accordance
Class A
are directly connected to a public
with IEC 61000-3-2
supply network which is also
Output of voltage fluctuations/
Complies
used to supply buildings used for
flickering to IEC 61000-3-3
residential purposes.
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Instructions for use
Barkey Prismacomfort
3.4.2
Use for the intended purpose / safety instructions
Electromagnetic immunity
Guidelines and manufacturers declaration - Electromagnetic immunity
The Barkey autocontrol 3XPT is intended for operation in any of the electromagnetic
environments listed below. The customer or user of the Barkey autocontrol 3XPT must ensure
that it is operated in one of these environments.
IEC 60601 test
Electromagnetic environment Immunity test
Compliance level
level
Guideline
The floor should be made of
± 6 kV
± 6 kV
Static electrical
wood or concrete or be covered
contact discharge contact
discharge (ESD)
with ceramic tiles. If the floor is
discharge
to
covered with synthetic material,
± 8 kV air
IEC 61000-4-2
the relative humidity must be at
discharge
± 8 kV air discharge
least 30%.
± 2 kV for power ± 2 kV for power
Rapid transient
cords
cords
The quality of the supply voltage
electrical noise/
should comply with a typical
bursts to
± 1 kV for input ± 1 kV for input and business or hospital environment.
IEC 61000-4-4
and output cords output cords
Surges according
to IEC 61000-4-5
Voltage dips,
short-time
interruptions and
fluctuations of
supply voltage to
IEC 61000-4-11
Magnetic field at
supply frequency
(50/60 Hz) to
IEC 61000-4-8
± 1 kV voltage
phase-phase
± 1 kV voltage
phase-phase
± 2 kV
voltage phaseearth
< 5 % UT
(> 95 % drop of
UT )
for ½ cycle
40 % UT
( 60 % drop of
UT ) for 5 cycles
70 % UT
( 30 % drop of
UT ) for 25
cycles
< 5 % UT
(> 95 % drop of
UT ) for 5s
3 A/m
Not applicable
(double insulated,
class II)
< 5 % UT
(> 95 % drop of UT
) for ½ cycle
40 % UT
( 60 % drop of UT )
for 5 cycles
70 % UT
( 30 % drop of UT )
for 25 cycles
< 5 % UT
(> 95 % drop of UT
) for 5s
3 A/m
The quality of the supply voltage
should comply with a typical
business or hospital environment.
The quality of the supply voltage
should comply with a typical
business or hospital environment.
If the user of the Barkey
autocontrol 3XPT requires
continued operation even if the
power supply is interrupted, we
recommend that the Barkey
autocontrol 3XPT is connected to
an uninterruptible power supply
or to a battery.
Magnetic fields at mains
frequency should comply with the
typical values as found in
business and hospital
environments.
NOTE: UT is the mains AC supply voltage before applying the test rule
16
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Customer service: +49 (5202) 9801-30 Fax: +49 (5202) 9801-99 - Email: info@barkey.de
Instructions for use
Barkey Prismacomfort
Use for the intended purpose / safety instructions
Guidelines and manufacturers declaration - Electromagnetic immunity
The Barkey autocontrol 3XPT is intended for operation in any of the electromagnetic
environments listed below. The customer or user of the Barkey autocontrol 3XPT must ensure
that it is operated in one of these environments.
IEC 60601
Electromagnetic environment Immunity test
Compliance level
test level
Guideline
Portable and mobile radio sets should
not be used within a distance from the
Barkey autocontrol 3XPT including
its cords that is less than the
recommended safety distance as
calculated by the relevant equation
for the transmitted frequency.
Recommended safety distance
d = 1.17
Wire-borne HF
interference to
IEC 61000-4-6
3 Veff
150 kHz up
to 80 MHz
3 Veff
150 kHz up to 80
MHz
Radiated HF
interference to
IEC 61000-4-3
3 V/m
3 V/m
80 MHz up to 80 MHz up to 2.5
2.5 GHz
GHz
d = 1.17
for 80 MHz to 800 MHz
d = 2.33
for 800 MHz to 2.5 GHz
where P is the nominal power of the
transmitter in Watts (W) as stated by
the transmitter manufacturer and d is
the recommended safety distance in
metres (m).
An on-site investigation a must show
that the field strength of stationary
transmitters is less than the
compliance levelb at all frequencies.
Interference is possible near devices
that display the following symbol.
NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies.
NOTE 2 These guidelines may not apply in all cases. The
propagation of electromagnetic radiation is affected by absorption and reflection of buildings,
objects and people.
a
The field strength of stationary transmitters, such as base stations of radio telephones and
mobile land radios, amateur radios, AM and FM radio and television transmissions cannot be
precisely theoretically predetermined. You should consider carrying out a site study to determine
the electromagnetic environment with regard to stationary transmitters. If the measured field
strength at the location where the Barkey autocontrol 3XPT is being used exceeds the above
compliance levels, the Barkey autocontrol 3XPT should be monitored to ensure that the device is
functioning as intended. If unusual performance characteristics are observed, additional measures
such as changing the alignment or location of the Barkey autocontrol 3XPT may be necessary.
b
The field strength should be less than 3 V/m in the frequency range 150 kHz to 80 MHz.
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Instructions for use
Barkey Prismacomfort
3.4.3
Use for the intended purpose / safety instructions
Recommended safety distance
Recommended safety distances between portable and mobile
HF telecommunications devices and the Barkey autocontrol 3XPT
The Barkey autocontrol 3XPT is intended for operation in an electromagnetic environment in
which HF interference is controlled. The customer or user of the Barkey autocontrol 3XPT
can help avoid electromagnetic interference by observing the minimum distance between
portable and mobile HF communications devices (transmitters) and the Barkey autocontrol
3XPT as stated below, depending on the output power of the communication device.
Safety distance depending on transmitter frequency m
800 MHz
150 kHz to
80 MHz to
Nominal power
to 2.5
80 MHz
800 MHz
of the transmitGHz
ter W
d  1.17 P
d  1.17 P
d  2.33 P
0.01
0.12
0.12
0.23
0.1
0.37
0.37
0.74
1
1.17
1.17
2.33
10
3.69
3.69
7.38
100
11.67
11.67
23.33
For transmitters whose maximum nominal output is not given in the above table, the recommended safety distance d in metres (m) can be calculated using the equation belonging to the
appropriate column, where P is the maximum nominal output of the transmitter in Watts (W)
as stated by the transmitter manufacturer.
NOTE 1 The higher frequency level applies at 80 MHz and 800 MHz.
NOTE 2 These guidelines may not apply in all cases. The propagation of electromagnetic
variables is affected by absorption and reflection of buildings, objects and people.
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Instructions for use
Barkey Prismacomfort
Controls and displays
4
Controls and displays
4.1
Operating panel
The Barkey autocontrol 3XPT control unit is provided with an operating panel on the
front with a multi-line display, 4 buttons and 4 lights (LEDs).
Figure 6: Barkey autocontrol 3XPT operating panel
The display is for:

displaying the menu system for the operation of the device;

information about the heaters connected and the current target and actual values;

outputting error messages.
An acoustic buzzer alerts you to the fact that an error has occurred. A message is also
shown in the display.
Please also observe the following table of displays and controls.
Button for turning the device on and off.
Selection buttons for menu operation.
Each button has its function shown in the display.
Confirmation button for menu navigation selection. Use this button to
acknowledge the OK display each time.
The green light (LED) shows that the device has been switched on.
The orange lights 1 and 2 show that a heater has been connected to
channel 1 or channel 2.
The yellow light (LED) indicates a device malfunction.
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Instructions for use
Barkey Prismacomfort
4.2
Controls and displays
Symbols on labels
Labels showing printed symbols are affixed to the device. These have the following
meaning:
This symbol declares that the device conforms with EU Directive
93/42/EEC of 14th June 1993 for medical devices. The four-digit
number indicates the appointed body (TÜV Product Service) which
supervises the manufacturer's quality assurance system.
IPX1
This symbol means that the device is protected against vertically dripping water according to IEC 601-1 in its intended operation conditions.
This symbol indicates that the device with its application part is of type
CF (cardio floating) and is defibrillation proof.
This symbol shows the year of manufacture as a four-digit number.
2015
This symbol indicates that the product may not be disposed of with
normal domestic waste. This product must be disposed of by specialist
disposal companies or returned to the manufacturer for disposal.
This symbol indicates that the device is double insulated to protection
class II.
This symbol indicates that the mains plug must be withdrawn from the
socket before the device housing is opened.
This symbol advises you that you must comply with the user manual
supplied.
20
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Controls and displays
Instructions for use
Barkey Prismacomfort
This symbol identifies the month and the year in which the next safety
inspection must be carried out.
This symbol indicates the humidity range which the medical device can be safely exposed to. The values limiting
humidity are located next to the upper and lower horizontal
line. You can find the limit values in the “Technical data”
section.
This hazard symbol advises you that failure to follow the instructions
contained in this user manual can result in hazards to patients, the device user or the device itself.
Instructions for use Barkey Prismacomfort - V3 EN - pc-100-EW-0005-02 - 2015-12-07
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Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe - Germany - Switchboard: +49 (5202) 9801-0
Customer service: +49 (5202) 9801-30 Fax: +49 (5202) 9801-99 - Email: info@barkey.de
Instructions for use
Barkey Prismacomfort
4.3
Controls and displays
Safety instructions sticker for Barkey autoline XPT 4R heater
A sticker is attached to the front panel of the Barkey autocontrol 3XPT control unit
containing printed symbols which show which safety instructions must be observed in
particular during use of the Barkey autoline XPT 4R heater, or how the Barkey autoline
XPT 4R heater may not be used.
WARNING
If instructions contained in this user manual are not observed, hazards can occur for
patients, the device user or the device itself.
Before starting to use the device, read this user manual thoroughly.
Do not kink, cover, warm or cool the heater! Do not cover the heaters with cloths
or dressing materials, do not run them under bedcovers, hot-air covers, etc., and do
not expose them to direct sunlight or thermal radiation. Only run the heater uncovered through the air. Do not run into or through incubators!
Do not shorten or damage the heater.
Figure 7: Barkey autoline safety instructions sticker
22
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Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe - Germany - Switchboard: +49 (5202) 9801-0
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Setting up, getting started
5
Setting up, getting started
5.1
Set-up location
Instructions for use
Barkey Prismacomfort
The Barkey Prismacomfort is designed for use indoors as a fixed installation.
CAUTION
When selecting a site for the device it is imperative that you maintain the distances
from other devices with electromagnetic emission as stated in Chapter 3 of this
user manual.
CAUTION
Before starting to use the device, check it for damage on each occasion. If the device is damaged, do not use it.
CAUTION
Install the device so that the mains plug is accessible at all times and the mains
plug can easily be withdrawn from the socket, for instance in an emergency.
5.2
Installation of the Barkey Prismacomfort
5.2.1
Installing the control unit
The Barkey autocontrol 3XPT control unit is attached by fixing the lug on the back of the
casing (see Figure 8) to the bracket on the Prismaflex haemodialysis system from Gambro
Renal Products.
Screw the Barkey autocontrol 3XPT control unit to the bracket on the Prismaflex haemodialysis system as shown in Figure 8. For fixing use the two screws (hexagon socket-head
screws) and the tool (hexagon L-wrench), supplied with the bracket by Gambro.
Step 1
Step 2
Figure 8: Installing the Barkey autocontrol 3XPT control unit
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Instructions for use
Barkey Prismacomfort
Setting up, getting started
CAUTION
During installation, hold the Barkey autocontrol 3XPT firmly by the carrying grip,
since it is important to avoid dropping it and thereby damaging the control unit.
Lay the control unit power cord as shown in Figure 9, passing it through the plastic clip
on the inside of the Prismaflex haemodialysis system bracket and behind the lower handle
on the Prismaflex haemodialysis system.
Figure 9: Routing of the power cord for the Barkey autocontrol 3XPT control unit
CAUTION
When routing the power cord for the Barkey autocontrol 3XPT control unit, ensure
it does not interfere with the Prismaflex haemodialysis system scales.
24
Instructions for use Barkey Prismacomfort - V3 EN - pc-100-EW-0005-02 - 2015-12-07
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Setting up, getting started
5.2.2
Instructions for use
Barkey Prismacomfort
Installing the Barkey autoline XPT 4R heater support
The support for the Barkey autoline XPT 4R heater is bolted to the right hand side of the
haemodialysis system casing. The support has two holes for installation. Corresponding
drilling points can be found on the right hand side of the Prismaflex haemodialysis
system casing. These holes in the support determine its position on the haemodialysis
system since they correspond to the drilling points on the right hand side of the
Prismaflex haemodialysis system casing.
Before the support can be bolted to the Prismaflex haemodialysis system casing, the two
drilling points on right hand side of the haemodialysis system casing must be drilled out
with a sharp object.
The support for the Barkey autoline XPT 4R heater is then bolted to the Prismaflex
haemodialysis system with the two Torx screws (included in the scope of supply).
To install the support for the Barkey autoline XPT 4R heater, follow the individual steps
shown in Figure 10.
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Instructions for use
Barkey Prismacomfort
Setting up, getting started
Step 1
Step 2
Step 3
Step 4
Step 5
Figure 10: Installing the Barkey autoline XPT 4R heater support
CAUTION
The free end of the Barkey autoline XPT 4R heater can be inserted into one of the
slots on the support for the Barkey autocontrol 3XPT control unit. That prevents
the heater touching the floor and thus possibly suffering damage.
26
Instructions for use Barkey Prismacomfort - V3 EN - pc-100-EW-0005-02 - 2015-12-07
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Instructions for use
Barkey Prismacomfort
Setting up, getting started
5.2.3
Installing the cable guide for the Barkey autoline XPT 4R heater
The purpose of the plastic clip supplied is to guide the power cable of the Barkey autoline
XPT 4R heater and prevent it interfering with the Prismaflex haemodialysis system
scales.
For correct installation of the cable guide, proceed as shown in Figure 11. Remove the
upper left screw of the power cord cover at the back of the Prismaflex haemodialysis
system casing, fit the clip and tighten the screw again. Then feed the connection cable for
the Barkey autoline XPT 4R heater through the plastic clip.
Figure 11: Installing the Barkey autoline XPT 4R cable guide
CAUTION
Only by correct installation of the cable guide and insertion of the power cord in it
can interference with the Prismaflex haemodialysis system scales be avoided.
5.2.4
Installation of the Barkey autoline XPT 4R heater
The device head of the Barkey autoline XPT 4R heater is inserted into the support (see
Chapter 5.2.2) as shown in Figure 12.
Figure 12: Inserting the autoline XPT 4R heater
Feed the heater power cord through the plastic clip at the back of the Prismaflex
haemodialysis system casing, as described in Chapter 5.2.3.
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Instructions for use
Barkey Prismacomfort
Setting up, getting started
CAUTION
Only by correct installation of the cable guide and insertion of the power cord in it
can interference with the Prismaflex haemodialysis system scales be avoided.
CAUTION
The free end of the Barkey autoline XPT 4R heater can be inserted into one of the
slots on the support for the Barkey autocontrol 3XPT control unit. That prevents
the heater either touching the floor and thus possibly suffering damage, or that the
heater interferes with the Prismaflex haemodialysis system scales.
28
Instructions for use Barkey Prismacomfort - V3 EN - pc-100-EW-0005-02 - 2015-12-07
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Instructions for use
Barkey Prismacomfort
Setting up, getting started
5.3
Connection of the Barkey autoline XPT 4R heater to the control unit
The Barkey autoline XPT 4R heater can be connected to the Barkey autocontrol 3XPT
control unit, irrespective of whether the control unit is switched on or not. The heater and
the control unit support "hot-plugging", so the parameters are read electronically and
correct regulation is established even if the control unit is switched on when the
connection to the heater is made.
The connection plug for the heater is inserted into the relevant socket for channel 1 or 2 at
the Barkey autocontrol 3XPT control unit (it is the user's free choice which of the two
channels is selected for connecting the heater). The connection plugs for the heaters and
the sockets at the control unit are each provided with a red position indication dot. When
the plug is inserted the dots must be in line. Once it is plugged in, each connection plug is
automatically secured by a catch and cannot be pulled out by accident.
Knurled sleeve
Red dot
Figure 13: Heater plugs
To unplug the connector, release the catch by pulling back the knurled sleeve on the connector (see Figure 14).
Figure 14: Releasing the connector
After a heater has been connected or disconnected to or from the control unit, wait
approx. 6 seconds for the channel parameters and the display to be updated.
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Instructions for use
Barkey Prismacomfort
Setting up, getting started
WARNING
Once a heater has been connected to the Barkey autocontrol 3XPT, it must remain
connected for at least 6 seconds. Otherwise the parameters saved in the heater will
not be recognised correctly.
WARNING
Once a heater has been disconnected from the Barkey autocontrol 3XPT, you must
wait at least 6 seconds before connecting another heater. Otherwise the parameters
saved in the heater will not be recognised correctly.
CAUTION
Never unscrew the heater connection plug. This might damage the electronics
contained within it.
Figure 15 shows a Barkey Prismacomfort blood heater fully installed on a Prismaflex
haemodialysis system.
Side view
Front view
Figure 15: Barkey Prismacomfort fully installed on a Prismaflex haemodialysis system.
30
Instructions for use Barkey Prismacomfort - V3 EN - pc-100-EW-0005-02 - 2015-12-07
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Instructions for use
Barkey Prismacomfort
Setting up, getting started
5.4
Positioning the Barkey autocontrol 3XPT control unit
The Barkey autocontrol 3XPT control unit must always be positioned appropriately for its
intended use.
When the Prismaflex haemodialysis system is in its transport storage position (see Figure
16) it can be moved to another location and the Prismacomfort blood heater can be stored
on the Prismaflex haemodialysis system.
Figure 16: Barkey Prismacomfort transport and storage position
The operating position (see Figure 17) is used when performing treatment.
Figure 17: Barkey Prismacomfort operating position
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Instructions for use
Barkey Prismacomfort
Setting up, getting started
WARNING
The Barkey Prismacomfort blood heater must never be transported or operated in
the positions shown in Figure 18, lest damage to the Barkey autocontrol 3XPT
control unit or to the Prismaflex haemodialysis system should occur.
Figure 18: Prohibited transport and storage positions for the Barkey Prismacomfort
32
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Instructions for use
Barkey Prismacomfort
Setting up, getting started
5.5
Inserting the blood return flow tube into the heater
The Barkey autoline XPT 4R heater is shaped as a "slit silicone tube" which can fully envelop the 6.55 mm diameter blood return flow tubes attached to the Gambro Prismaflex
range of haemodialysis systems. This complete enveloping of the tube being heated ensures no heat is lost to the environment. Other heaters are available to suit blood return
flow tubes with smaller outside diameters. These heaters and can be ordered as required
from Gambro sales offices.
The lengths of Barkey autoline XPT 4R heaters match those of the blood return flow
tubes. Insert the blood return flow tube into the heater as shown (Figure 19). Start at the
patent end of the blood return flow tube about 3 cm up from the Luer-Lock connection to
the blood return flow tube. Slightly open the end of the Barkey autoline XPT 4R heater
and insert the end of the blood return flow tube. Use your thumbs to press the blood return flow tube along the slit in the heater. The blood return flow tube will slip into the
heater and thus can be slid along so that it directly abuts the connection head.
Repeat this until the entire length of the blood return flow tube is enveloped within the
heater.
app. 3cm
1.
2.
3.
4.
Figure 19: Inserting the blood flow return tube
NOTE
The entire length of the blood return flow tube of the Prismaflex haemodialysis
system must be inserted and enveloped within the Barkey autoline XPT 4R heater
to ensure optimum effectiveness of the heater.
The heater with the inserted blood return flow tube is inserted back into the heater support
as shown in Figure 20. Please note that a slight reverse loop must be incorporated in the
blood return flow tube between the head of the Barkey autoline XPT 4R heater and the
Prismaflex haemodialysis system.
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Instructions for use
Barkey Prismacomfort
Setting up, getting started
Step 1
Step 2
Step 3
Figure 20: Inserting the heater containing the blood return flow tube
WARNING
There must be no kinks in the blood return flow tube which would restrict the flow
of blood to the patient.
Figure 21 shows a Barkey Prismacomfort with an inserted blood return flow tube
mounted on a Prismaflex haemodialysis system.
Figure 21: Barkey Prismacomfort on a Prismaflex
34
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Setting up, getting started
5.6
Instructions for use
Barkey Prismacomfort
Getting started
If you are using a new or repaired device you should first

select a suitable installation location for it;

install the components correctly;

and correctly connect and route the necessary cables.
CAUTION
A disinfectant wipe of the heater must be carried out each time before it is used.
This procedure is described in Chapter 7 of this user manual.
5.6.1
Connecting the Barkey autocontrol 3XPT control unit to the power supply
The power supply must correspond to the data on the rating plate, the technical data for
the device, and the applicable regulations for electrical installations.
The autocontrol 3XPT control unit is connected to the power supply by a permanent
power supply cord. This is done by plugging the power supply plug on the power supply
cord into a power supply socket.
5.6.2
Switching on the Barkey autocontrol 3XPT control unit
►
Press the top button on the operating panel to turn the device on.
CAUTION
Ensure that when the device is powered on, an acoustic signal sounds twice and the
yellow and orange LED's flash twice.
Make sure that the flashing light and the acoustic signal are actuated by the device
and that they are clearly perceptible. This will ensure that the displays and controls
are functioning correctly.
The manufacturer's logo appears in the display for approx. 5 seconds. An internal system
test is in performed during this time.
After self-test of the control unit has been performed (approx. 10 s) and the parameters
have been read from the Barkey autoline XPT 4R heater, the main menu appears in the
display screen.
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Instructions for use
Barkey Prismacomfort
6
Operation
6.1
Main screen
Type of heater
Set value
channel 1
Actual value
channel 1
Operation
Channel 1:
autoline
Set to 41.0
Channel 2
Set to – –.–
39.3°C – –.–°C
Set value
channel 2
Actual value
Menu
channel 2
Figure 22: Main screen
Once the device has been switched on and performed the self-test, the main screen appears on the Barkey autocontrol 3XPT control unit. This shows the heater type "autoline",
the set value and the actual value for each channel. The menu can be called up by pressing the centre button under the display.
The heaters connected are heated up to their set values. Connection of a heater is indicated by the channel detection indicator (orange LED) for the respective channel lighting
up to the left or right of the display.
If no heaters are connected, no type data or set values are displayed and three horizontal
dashes appear instead of the actual values.
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Instructions for use
Barkey Prismacomfort
Operation
6.2
Menu structure
Press the centre button under the display; this is assigned to the menu display. A menu
with the following selection options then appears:
Temperature measurement The temperature of an external temperature sensor is
displayed.
Set value channel 1
The set value for channel 1 can be changed.
Set value channel 2
The set value for channel 2 can be changed.
Nighttime mode
Nighttime mode (in which the display and the orange
LEDs are illuminated) can be switched on and off.
next
Switching to the second menu screen.
Language
A different menu language can be selected.
Information System
Information about the control unit is displayed.
Information channel 1
Information about a heater connected to channel 1 is
displayed.
Information channel 2
Information about a heater connected to channel 2 is
displayed.
back
Switching to the first menu screen.
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Instructions for use
Barkey Prismacomfort
Operation
Temperature measurement
Set value channel 1
Set value channel 2
Nighttime mode
Language
Information System
Information channel 1
Information channel 2
next =>
<= back
Select
OK
End
Select
OK
End
Figure 23: Menu screens 1 and 2
Functions which are listed in the bottom line of the display are assigned to the three
buttons under the display. The individual menu items can be highlighted one after the
other using the left-hand "Select" button. Pressing the middle "OK" button actuates the
highlighted menu item and the selected item appears in the display. When the "next" and
"back" menu items are pressed, the changeover is performed by pressing the left hand
button "Select". Press the right-hand "End" button to return to the main screen.
If no button is pressed within 30 seconds the display automatically reverts to the main
screen.
The functions of the three buttons change depending on the selected option and are
described below for the individual options.
6.2.1
Temperature measurement
The temperature of an external ambient temperature sensor or of an external temperature
sensor is shown in the display. Pressing the middle "Back" button takes you back to menu
screen 1.
Ambient temperature:
20.9
°C
35.5
°C
external sensor:
Back
Figure 24: Temperature measurement
If no external ambient temperature sensor or external temperature sensor is connected,
horizontal dashes are shown. After 30 seconds the display reverts to the main screen.
If no external sensors are connected this menu item is not available for selection.
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Instructions for use
Barkey Prismacomfort
Operation
6.2.2
Set value setting, channel 1
At the left side of the display, the header "Channel 1" appears. The heater type appears in
the second line, e.g. "autoline" and in the existing set value appears in the third line. In
addition the display "°C" flashes. The set value can be incremented and decremented in
0.5 °C steps using the left hand and right hand buttons. Use the left-hand button "-" to
decrement the set value and the right-hand button "+" to increment it.
Channel 1:
autoline
Set 37.0
37.0
–
°C
OK
+
Figure 25: Set value setting, channel 1
To load the changed set value the new setting must be confirmed by pressing the middle
"OK" button. After the changed set value has been confirmed, the "°C" stops flashing. To
revert to menu screen 1 press the "Back" button. The heater will now heat up/cool down
to the new temperature which you have selected.
If the “Back” button is not pressed the display will automatically revert to the main screen
after 30 seconds.
If no heater is connected to channel 1, this menu item is not available for selection. The
highlighting switches automatically to the "Temperature measurement" menu item.
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Instructions for use
Barkey Prismacomfort
6.2.3
Operation
Set value setting, channel 2
At the right side of the display, the header "Channel 2" appears. The heater type appears
in the second line, e.g. "autoline" and in the existing set value appears in the third line. In
addition the display "°C" flashes. The set value can be incremented and decremented in
0.5 °C steps using the left hand and right hand buttons. Use the left-hand button "-" to
decrement the set value and the right-hand button "+" to increment it.
Channel 2:
autoline
Set 37.0
37.0
–
°C
OK
+
Figure 26: Set value setting, channel 2
To load the changed set value the new setting must be confirmed by pressing the middle
"OK" button. After the changed set value has been confirmed, the "°C" stops flashing. To
revert to menu screen 1 press the "Back" button. The heater will now heat up/cool down
to the new temperature which you have selected.
If the “Back” button is not pressed the display will automatically revert to the main screen
after 30 seconds.
If no heater is connected to channel 2, this menu item is not available for selection. The
highlighting switches automatically to the "Temperature measurement" menu item.
40
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Instructions for use
Barkey Prismacomfort
Operation
6.2.4
Nighttime mode
In nighttime mode the orange channel detection indicators and the illumination of the display are switched off. If whilst in nighttime mode any of the three buttons under the display is pressed, the illumination is switched on for 30 seconds.
Nighttime mode
(illumination of the
displays only if a
button is pressed)
Illumination
off
Back
on
Figure 27: Nighttime mode
Pressing the left hand "illumination off" button switches nighttime mode on; pressing the
right hand "illumination on" button switches nighttime mode off.
6.2.5
Language
You can choose between various different languages for the display. Use the left-hand
"Select" button to highlight the desired language.
Confirm your choice by pressing the middle "OK" button – all the items in the display
will now be shown in your selected language. Press the right-hand "End" button to return
to menu screen 1.
Please select
the language:
German
Dutch
Italian
French
Select
OK
End
Figure 28: Language
If no button is pressed within 30 seconds the display automatically reverts to the main
screen.
The language selection is not lost when the autocontrol 3XPT control unit is switched off
and on again.
The language must be selected again following a battery change.
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Instructions for use
Barkey Prismacomfort
6.2.6
Operation
System information
The "System information" menu displays the name of the control unit, its serial number,
its date of manufacture, the date of its last calibration and its software version.
System information:
Name
: ac 3XPT
SN
: 1200000
Man. date: 08.02.06
Calibr.
: 15.02.06
Version : sv 1.5
Back
Figure 29: Information System
Pressing the "Back" button takes you back to menu screen 2.
If the "Back" button is not pressed the display will automatically revert to the main screen
after about 30 seconds.
6.2.7
Information channel 1
The "Channel 1 information" menu displays the name of the heater connected to channel
1, its serial number, its date of manufacture and the date of its last calibration. Pressing
the "Back" button takes you back to menu screen 2. If the "Back" button is not pressed
the display will automatically revert to the main screen after about 30 seconds.
Information: Channel 1
Name
: autoline
SN
: 2300000
Man. date: 12.02.06
Calibr.
: 13.02.06
Back
Figure 30: Information channel 1
If no heater is connected to channel 1, this menu item is not available for selection. The
highlighting switches automatically to the "Language selection" menu item.
42
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Instructions for use
Barkey Prismacomfort
Operation
6.2.8
Information channel 2
The "Channel 2 information" menu displays the name of the heater connected to channel
2, its serial number, its date of manufacture and the date of its last calibration. Pressing
the "Back" button takes you back to menu screen 2. If the "Back" button is not pressed
the display will automatically revert to the main screen after about 30 seconds.
Information: Channel 2
Name
: autoline
SN
: 2300000
Man. date: 12.02.06
Calibr.
: 13.02.06
Back
Figure 31: Information channel 2
If no heater is connected to channel 2, this menu item is not available for selection. The
highlighting switches automatically to the "Language selection" menu item.
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Instructions for use
Barkey Prismacomfort
7
Cleaning and care
Cleaning and care
The smooth surfaces and rounded corners of the control unit make it simple and easy to
clean the Barkey Prismacomfort blood heater for Prismaflex.
The heaters must be cleaned and disinfection-wiped as required, if possible after each
time they are used.
WARNING
Disconnect the heater from the control unit by releasing and withdrawing its connection plug.
Do not pour cleaning fluid or disinfectant directly on to the heater. Always moisten
a cloth and then use this cloth to clean the heater.
Never apply cleaning agents to the ventilation openings on the control unit.
Never use steam (i.e. in autoclaves), hot air or thermo-chemical cleaning solutions
to disinfect the control unit and heater. Dry the surfaces and use a surface disinfectant. Take into account the time needed to take effect!
You should use standard commercial preparations based on alcohol without oxygenreleasing components (with sodium hydrochloride with 1.4% bleach solution or aldehyde
content < 0.2%) as a disinfectant.
►
If possible clean the heater with a solution of soap and water.
►
Dry the surfaces and use a surface disinfectant. Observe the acting time stated by
the disinfectant manufacturer!
►
After allowing the disinfectant time to take effect, dry the device off with disposable tissues.
CAUTION
You should never use any cleaning or decontamination processes except those recommended by the manufacturer without first checking with the manufacturer to see
whether these proposed processes will damage the device.
Otherwise, please refer to the hygiene measures and regulations which apply in
your hospital.
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Maintenance
8
Instructions for use
Barkey Prismacomfort
Maintenance
Besides cleaning the device and performing the electrical safety checks, other maintenance measures that must be carried out are a regular safety check and regular battery replacement.
These two operations may be carried out only by qualified service personnel or employees of Barkey GmbH & Co. KG or Gambro. Training for medical technicians in checking
and repairing the Barkey Prismacomfort is available at the Barkey GmbH & Co. KG factory. Please call us on +49 (5202) 9801-30 for information about current availability and
costs.
At the end of this user manual you will find a blank form for a device master data sheet.
This can be used as the front page for a service history in which all maintenance work
should be recorded.
8.1
Technical safety inspection (TSI)
As with all electronic devices, the Barkey Prismacomfort’s temperature setting is subject
to normal ageing and the tolerances of the electronic components.
To ensure that the temperature settings on the Barkey Prismacomfort are always within
the stated tolerances, a technical safety inspection (TSI) must be carried out each year by
qualified service personnel or by employees of Barkey GmbH & Co. KG (see § 6 MPBetreibV*).
The technical safety inspection should also include the prescribed electrical safety check
on the Barkey Prismacomfort.
As soon as a safety inspection for the control unit or a heater connected to it becomes
due, when you switch on the control unit you will be automatically reminded of the requirement for safety inspection of the respective device by a message in the display.
When the Barkey autocontrol 3XPT control unit is switched on it performs a self-check.
A safety inspection therefore extends to the measurement functions at the signal inputs
and the checking of the overtemperature protection function. Safety inspections also include checking the ventilation grilles at the air intake and outlet and cleaning them as
necessary.
Inspection of Barkey autoline 4R XPT heaters also includes checking the temperature
value actually achieved by the heater. If deviations from the set value greater than ± 1°C
occur, the device must be recalibrated. Correction of the temperature setting can be performed only at Barkey GmbH & Co. KG.
All the work necessary for servicing and for the TSI is described in a separate service
manual which can be requested from Barkey GmbH & Co. KG.
* MPBetreibV  Operators of Medical Products Directive
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Instructions for use
Barkey Prismacomfort
8.2
Maintenance
Replacing the battery
The device battery (lithium battery CR 1225, 3 V) must be replaced every 3 years.
CAUTION
Only qualified service personnel, employees of the Gambro Renal Products sales
office and employees of Barkey GmbH & Co. KG may change the battery. Please
dispose of any batteries properly in accordance with regulations. The internal
device clock and the language setting of the Barkey autocontrol 3XPT control unit
will need to be reset after the battery has been changed.
46
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Instructions for use
Barkey Prismacomfort
Error messages
9
Error messages
If an error message is displayed, please proceed as follows:
►
Note the error message.
►
Make a note of the error number and serial number.
►
Switch off the device.
►
Notify a medical technician or the service department at Gambro Renal Products
sales offices or Barkey GmbH & Co. KG
NOTE
In some cases, the serial number of the device will not be shown with an error
message. You can also find the serial number on the nameplate on the rear of the
control unit or on the heater control lines.
If an error occurs, the yellow "Error" light will light up. The display shows the code for
the last occurring error.
The following error is present:
No.: 104
BARKEY Service:
+49 5202 / 9801 -30
Figure 32: Error messages
All error codes: less than 100 relate to the control unit,
from 100 to 199 relate to the channel 1;
from 200 to 255 relate to the channel 2.
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Instructions for use
Barkey Prismacomfort
Error messages
Error codes for Barkey autocontrol 3 XPT control unit:
Error
code
10, 12
Error description
Comments
Display is incorrect
There may be no text visible in the
display. What appears the display may
be incorrect. This also involves the
temperatures displayed.
20 to 23 Internal device data incorrect
30
Checksum for internal device data is
incorrect
31
Checksum of the battery-powered
backup memory is incorrect
32
40
41
42
43
44
45
Checksum of the program memory is
incorrect
Clock is incorrect
Error when setting clock time
Error when setting date
Error when reading clock time
Error when reading date
Clock not running
50
Switch-off relay is faulty
51
The "watchdog timer" is defective
The "watchdog timer" has detected an
error
61
No power supply for the heaters
70 to 73 Error during temperature
measurement
74
Overtemperature in the control unit
Replace the battery (only by
authorised specialist personnel).
Note: If the battery has gone flat all
text is displayed in the English
language.
Replace the battery (only by
authorised specialist personnel). Then
set the time and date.
In the event of an error, this relay cuts
off the power supply to the heaters.
Note: Correct functioning of this relay
is tested every time the device is
switched on.
A monitoring module which monitors
the correct operation of the control
unit.
Note: Correct functioning of this
module is tested every time the device
is switched on.
60
Possible cause: Fuse F110 blown
Possible cause: sensor breakdown /
sensor short-circuit
Possible cause: Fan defective,
ventilation grille clogged
48
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Instructions for use
Barkey Prismacomfort
Error messages
Error codes for heater channel 1
Error Error description
code
Channel 1:
100 to Incorrect heater data
102
103
Checksum of the device data is
incorrect
104
Software overtemperature
105
Electronic overtemperature
Error codes for heater channel 2
Error
Error description
code
Channel 2:
200 to Incorrect heater data
202
203
Checksum of the device data is
incorrect
204
Software overtemperature
205
Electronic overtemperature
Comments
The measured temperature is more
than 1.0°C over the set value
temperature for this heater.
An overtemperature protection which
is independent of the software and
which cuts out the heater at a
temperature of 45.5°C ± 1.5°C.
Comments
The measured temperature is more
than 1.0°C over the set value
temperature for this heater.
An overtemperature protection which
is independent of the software and
which cuts out the heater at a
temperature of 45.5°C ± 1.5°C.
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Instructions for use
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Warranty and disclaimer of liability
10 Warranty and disclaimer of liability
Due to the fact that Barkey GmbH & Co. KG has absolutely no control over the quality of
maintenance work which is not carried out by Barkey personnel, and that Barkey GmbH
& Co. KG cannot estimate what effects such service and repair work will have on the
device and its serviceability, Barkey GmbH & Co. KG accepts absolutely no
responsibility for material damages, injuries or consequential damages which result from
use of a device which has not been repaired or maintained by Barkey service personnel.
Barkey GmbH & Co. KG categorically declines all responsibility whatsoever for indirect
damages or consequential damages of any type, and restricts its liabilities exclusively to
repair or replacement of the device.
Barkey GmbH & Co. KG grants this warranty in place of contractually or legally required
warranties on this product, including other statutory guarantees of marketability or
suitability for a particular use, and accepts no other liabilities.
The manufacturer accepts absolutely no responsibility or liability for the use of accessory
parts other than those listed in this user manual, for the use of non-original components,
and for the use/fitting which does not comply with the user manual accompanying these
components. The use of other components and accessories than those listed in the user
manual leads to a reduction of the manufacturer's warranty for the device.
Barkey GmbH & Co. KG only holds itself responsible for effects on the safety, reliability
and performance of the device when

extensions, resettings, modifications or repairs
are carried out by persons it has authorised, and

technical safety inspections have been demonstrably carried out by suitable
specialist personnel at the prescribed intervals, and

electrical installation has been carried out in accordance with German VDE
stipulations or similar, and

the device is used in accordance with this user manual, and

electrical safety checking has been demonstrably carried out in accordance with the
applicable regulations at the prescribed intervals.
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Instructions for use Barkey Prismacomfort - V3 EN - pc-100-EW-0005-02 - 2015-12-07
Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe - Germany - Switchboard: +49 (5202) 9801-0
Customer service: +49 (5202) 9801-30 Fax: +49 (5202) 9801-99 - Email: info@barkey.de
Customer Service
Instructions for use
Barkey Prismacomfort
11 Customer Service
Operation of the Barkey Prismacomfort is almost totally maintenance-free and not susceptible to faults. Should a repair be necessary in spite of this, follow the guidance below:
Please send defective devices for recycling - repairs to any Gambro Renal Products sales
office or to Barkey GmbH & Co. KG. Recycling repairs save you the cost of recyclable
used parts. Barkey GmbH & Co. KG also ensures that materials are properly separated
and disposed of.
Barkey GmbH & Co. KG accepts no liability for alterations carried out without authorisation or overhaul to the devices carried out by the customer or non-authorised third parties.
We recommend that you have any necessary repairs and regular maintenance carried out
by Barkey GmbH & Co. KG or that you ensure your specialist personnel are trained at
our special product training sessions with regard to inspection and maintenance.
Please comply strictly with the following rules before dispatching the device:

Return the device for recycling repair only to Barkey GmbH & Co. KG or its
authorised distributor.

The device must be cleaned and if necessary disinfected before it is dispatched.

The returned device must not pose any kind of health risk, e.g. as a result of toxic,
carcinogenic, biohazardous or radioactive substances. The sender shall be held liable for any losses caused by inadequate cleaning and disinfection.

Each returned device must be accompanied by a formal certificate of cleaning.
Forms for this purpose are obtainable from Barkey GmbH & Co. KG on request.

For safety reasons, devices which have not been cleaned or which are not accompanied by a certificate of cleaning will be returned to sender without being examined or repaired.

Please follow the cleaning and disinfection procedures described in this user manual / operator manual.

Please send a brief description of the fault along with the device. This can save
costs for any troubleshooting necessary.

Please pack the device for dispatch to Barkey GmbH & Co. KG so that it cannot be
damaged in transit. Barkey GmbH & Co. KG can accept no liability for damage in
transit due to inadequate packing.
Instructions for use Barkey Prismacomfort - V3 EN - pc-100-EW-0005-02 - 2015-12-07
51
Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe - Germany - Switchboard: +49 (5202) 9801-0
Customer service: +49 (5202) 9801-30 Fax: +49 (5202) 9801-99 - Email: info@barkey.de
Instructions for use
Barkey Prismacomfort
Customer Service
The Barkey GmbH & Co. KG customer service is available as follows:
Monday to Friday
07:00 - 20:00
Saturday and Sunday
10:00 - 18:00
on the following telephone number +49 (5202) 9801-30,
Please ask the appropriate staff about additional customer service times at your Gambro
Renal Products sales office.
The manufacturer and/or its subsidiary companies can supply a service manual on
request, and on payment of a nominal fee, which contains all necessary circuit diagrams,
component lists, calibration instructions and service information. This service manual, if
used by suitably trained and qualified technical personnel, can be used to repair all
components of the device considered to be repairable by the manufacturer.
Our conditions for repair and assembly and our warranty conditions are applicable. Our
products are supplied according to the "General Conditions for the Supply of Products
and Services of the Electrical and Electronics Industry".
52
Instructions for use Barkey Prismacomfort - V3 EN - pc-100-EW-0005-02 - 2015-12-07
Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe - Germany - Switchboard: +49 (5202) 9801-0
Customer service: +49 (5202) 9801-30 Fax: +49 (5202) 9801-99 - Email: info@barkey.de
Instructions for use
Barkey Prismacomfort
Customer Service
11.1 Service information
If you require any technical assistance for the Prismacomfort device, please contact a
sales representative at one of the following addresses:
AUSTRALIA
Gambro PTY Ltd.
11-13 King Street
Oakleight
AU-VICTORIA 3166
Tel. +61-395-633400
Fax +61-395-630344
BELGIUM
Gambro NV/SA
15, Groenveldstraat
BE-3001 HEVERLEE
BELGIUM
Tel. +32-162-98750
Fax +32-162-26521
DENMARK
Gambro A/S
Jydekrogen 8
2625 VALLENSBAEK
Tel. +45-4362-0500
Fax +45-4362-0749
GERMANY
Gambro Hospal GmbH
Lochhamer Str. 15
D-82152 Planegg-Martinsried
Tel. +49-89-89933-0
Fax +49-89-89933-2999
Instructions for use Barkey Prismacomfort - V3 EN - pc-100-EW-0005-02 - 2015-12-07
53
Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe - Germany - Switchboard: +49 (5202) 9801-0
Customer service: +49 (5202) 9801-30 Fax: +49 (5202) 9801-99 - Email: info@barkey.de
Instructions for use
Barkey Prismacomfort
ESTONIA
Customer Service
Gambro ESTONIA
Raudtee 10-1
11614 TALLINN
Tel. +372-67231-60
Fax +372-67231-61
FINLAND
OY Gambro
Sahaajankatu 24
FIN-00810 HELSINKI
Tel. +358-97-594120
Fax +358-97-81146
FRANCE
Hospal S.A
61 av. Tony Garnier
F-69007 Lyon
Tel. +33-04-3728-1111
Fax +33-04-3728-11 44
GREAT BRITAIN Hospal Gambro Ltd
Unit 1 & 2, Ermine Business Park
Huntingdon
GB-CAMBRIDGESHIRE PE29
Tel. +44-1480-444-000
Fax +44-1480-434-084
HONG KONG
Gambro CHINA Ltd
Room 3206-8, 32/F New York Life
Tower
Windsor House
311 Gloucester Road, Causeway
Bay
HONG KONG
Tel. 852/2576 2688
Fax 852/2687 1255
54
Instructions for use Barkey Prismacomfort - V3 EN - pc-100-EW-0005-02 - 2015-12-07
Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe - Germany - Switchboard: +49 (5202) 9801-0
Customer service: +49 (5202) 9801-30 Fax: +49 (5202) 9801-99 - Email: info@barkey.de
Instructions for use
Barkey Prismacomfort
Customer Service
ITALY
Hospal S.p.A
Via Ferrarese, 219/9
I-40128 Bologna
Tel. +39-051-6382-411
Fax +39-051-3274-77
CANADA
Gambro Inc
9157, du Champ d´Eau
CDN St. Leonard,
QUEBEC H1P 3M3
Tel. +1-514-327-1635
Fax +1-514-327-0822
LATVIA
Gambro LATVIA
P.O Box 207
LV-1050 RIGA
Tel. +371-921-999
Fax +371-503-0116
LITHUANIA
Gambro Atstovybe
Kareiviu 6-406
LT-2012 Vilnius
Lithuania
Tel./Fax +370-277-6151
MEXICO
Gambro de MEXIKO S.A de CV
Vasco de Quiroga 1900, piso 3
MX-Santa Fe
MEXICO D. F. 01210
Tel. +52-52 92 31 00
Fax +52-52 92 31 13
Instructions for use Barkey Prismacomfort - V3 EN - pc-100-EW-0005-02 - 2015-12-07
55
Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe - Germany - Switchboard: +49 (5202) 9801-0
Customer service: +49 (5202) 9801-30 Fax: +49 (5202) 9801-99 - Email: info@barkey.de
Instructions for use
Barkey Prismacomfort
NETHERLANDS
Customer Service
Hospal BV
Franse Akker 1
NL-4824 AL BREDA
Tel. +31-7654-20 207
Fax +31-7654-26 621
NORWAY
Gambro A.S
Blixjordet, Trimveien
3188 HORTEN
Tel. +47-33-0308-50
Fax +47-33-0308-65
NEW ZEALAND
Gambro Pty Ltd
5B Target Court
Glenfield
NZ-AUCKLAND
Tel. +64-9-444-4779
Fax +64-9-443-2222
AUSTRIA
Gambro Hospal GmbH
Ricoweg 30 A
AT-2351 Wr. NEUDORF
Tel. +43-2-23-664-666
Fax +43-2-23-664-666-55
POLAND
Gambro POLAND sp. Zoo
ul. Cylichowska 13/15
PL-04-769 WARSAW
Tel. +48-226-1527-52
Fax +48-226-1527-53
56
Instructions for use Barkey Prismacomfort - V3 EN - pc-100-EW-0005-02 - 2015-12-07
Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe - Germany - Switchboard: +49 (5202) 9801-0
Customer service: +49 (5202) 9801-30 Fax: +49 (5202) 9801-99 - Email: info@barkey.de
Instructions for use
Barkey Prismacomfort
Customer Service
PORTUGAL
Gambro Lda
Av. Salgueiro Maia- 9
Parque Industrial Cotai Abóboda
2785-601. S. Domingos Rana
Tel. +351-21-445-0280
Fax +351-21-444-4216
SWEDEN
Gambro Lundia AB / Gambro
Svenska Försäljning
Krokslätts Fabriker 14
431 37 Mölndal
Sweden
Tel. +46-31-77693-53
Fax +46-31-77693-40
SWITZERLAND
Hospal Gambro SCHWEIZ AG
Sägereistrasse 24
CH-8152 GLATTBRUGG
Tel. +41-1-82882-82
Fax +41-1-82882-83
SINGAPORE
Gambro SINGAPORE
510 Thomson Road
#12-05 /06 SLF Building
SINGAPORE 298135
Tel. +65-356-96-70
Fax +65-356-96-71
SPAIN
Hospal S.A
Avda. de la Industria, 16
28820 Coslada (Madrid)
SPAIN
Tel. +34-91-4852-540
Fax +34-91-4852-610
Instructions for use Barkey Prismacomfort - V3 EN - pc-100-EW-0005-02 - 2015-12-07
57
Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe - Germany - Switchboard: +49 (5202) 9801-0
Customer service: +49 (5202) 9801-30 Fax: +49 (5202) 9801-99 - Email: info@barkey.de
Instructions for use
Barkey Prismacomfort
Customer Service
HUNGARY
Gambro Kft
Diosarok ut 5
1125 BUDAPEST
Tel. +36-1-202-6411
Fax +36-1-355-2989
USA
Gambro Renal Care Products, Inc
10810 West Collins Ave.
LAKEWOOD CO 80215-4498
Tel. +1-800-525-2623
Tel. +1-303-232-68 00
Fax +1-303-231-4032
REMAINING COUNTRIES
GAMBRO EXPORT
EUROPE, AFRICA &
MIDDLE EAST
Magistratsvagen 10
P.O. Box 10101
S-220 10 Lund
Middle East: +46-46-169-134
Africa: +46-46-169-270
Russia: +46-46-169-171
Eastern Europe +46-46-169-171
58
Instructions for use Barkey Prismacomfort - V3 EN - pc-100-EW-0005-02 - 2015-12-07
Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe - Germany - Switchboard: +49 (5202) 9801-0
Customer service: +49 (5202) 9801-30 Fax: +49 (5202) 9801-99 - Email: info@barkey.de
Instructions for use
Barkey Prismacomfort
Specifications
12 Specifications
Manufacturer
Barkey GmbH & Co. KG
Gewerbestrasse 8
33818 Leopoldshoehe
Germany
Tel.: +49 / 5202 / 9801-0
Fax: +49 / 5202 / 9801-99
Type
Barkey autocontrol 3XPT
Mains connection
230 VAC / 115 VAC
Mains frequency
50 / 60 Hz
Power consumption
200 VA at 115 VAC
220 VA at 230 VAC
Fuse rating
1 A slow-blow at 230 VAC
2 A slow-blow at 115 VAC
Battery type
Lithium battery CR 1225, 3 V
Outputs
for two XPT heaters
from the Barkey range
24 Volt DC / max. 65 W
Overtemperature protection
software-controlled: Set value + 1 °C
electronic: autoline XPT 4R 45.5 °C ± 1.5 K
Temperature setting
selectable from +33 to max. +43 °C
Ambient Temperature
relative atmospheric humidity
(non-condensing)
Air pressure
Operation
+10 to +40 °C
30 to 75 %
Storage/Transport
-20 to +70 °C
500 to 1060 hPa
Operation type
Continuous operation
Control unit dimensions
140 x 210 x 130 mm (W x D x H mm)
Weight
approx. 3.7 kg
Protection Class
II double insulated
Degree of protection
CF defibrillator protected
MDD* classification
II b
Moisture protection
IPX1
Certification
CE 0123
* MDD Medical Device Directive
Instructions for use Barkey Prismacomfort - V3 EN - pc-100-EW-0005-02 - 2015-12-07
59
Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe - Germany - Switchboard: +49 (5202) 9801-0
Customer service: +49 (5202) 9801-30 Fax: +49 (5202) 9801-99 - Email: info@barkey.de
Instructions for use
Barkey Prismacomfort master data sheetDevice master data sheet
Barkey Prismacomfort
Barkey Prismacomfort master data sheet
Device designation:
________________________________________
Serial numbers:
________________________________________
Inventory number:
________________________________________
Set-up location:
________________________________________
Commissioning date:
________________________________________
Identification:
0123
Manufacturer:
Barkey GmbH & Co. KG
Gewerbestrasse 8
33818 Leopoldshoehe
Germany
Telephone:
+49 / 5202 / 9801-0
Fax:
+49 / 5202 / 9801-99
Email:
info@barkey.de
Instructions for use Barkey Prismacomfort - V3 EN - pc-100-EW-0005-02 - 2015-12-07
Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe - Germany - Switchboard: +49 (5202) 9801-0
Customer service: +49 (5202) 9801-30 Fax: +49 (5202) 9801-99 - Email: info@barkey.de