Weyer Variotherm REA-KCE User manual

GmbH
Herrenhöhe 4 >D-51515 Kürten/Germany
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++49 2207-9698-0
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++49 2207-4750 >e-mail: [e-mail]
Variotherm REA-KCE 2043/ _________
Under-pad heating 2010/ _________
Radiant warmer 2200/ _________
Year of manufacture:
______________
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PRQTS
D 2002_01

Instructions for Use Neonatal Intensive Care System VARIOTHERM REA-KCE
D2002_01.doc 2/39
Normal use..............................................................................................................................4
General safety instructions .................................................................................................4
Transport and storage..........................................................................................................4
Ambient requirements ..........................................................................................................4
Structure and operating principle ......................................................................................5
1. Mobile trolley .....................................................................................................................5
1.1 Height adjustment facility.........................................................................................................5
1.2 Electrical distribution.......................................................................................................5
1.3 Upgrade items................................................................................................................5
2. Bassinet ............................................................................................................................6
2.1 Tilting facility..................................................................................................................6
3. Conductive under-pad heating..........................................................................................6
4. Wall system.......................................................................................................................6
5. Frame system ...................................................................................................................6
5.1 Take-off sockets.............................................................................................................6
5.2 Swivel facility for the radiant warmer .......................................................................................6
5.3 Upgrade items/accessories..............................................................................................7
6. Infrared radiant warmer.....................................................................................................7
Start-up and functions, functional test .............................................................................8
Functions of the conductive under-pad heating...................................................................10
First start of the conductive under-pad heating ......................................................................10
Temperature selection........................................................................................................10
Heating up from cold state ..................................................................................................11
Heating up from partly cooled state......................................................................................11
Repeated start from warm state...........................................................................................11
Alarms..............................................................................................................................11
Deviation between selected and actual temperature exceeding 1°C....................................11
Bassinet temperature exceeding 40°C.............................................................................12
Insufficient capacity of power failure alarm battery ............................................................12
Power failure alarm .......................................................................................................12
Temperature sensor alarm .............................................................................................12
System check....................................................................................................................13
End of operation ................................................................................................................13
Functions of the infrared radiant warmer .............................................................................14
First start of the radiant warmer...........................................................................................15
Functional process and alarms ............................................................................................16
Use..........................................................................................................................................18
Bassinet with wall system ....................................................................................................18
Temperature selection of the conductive under-pad heating...............................................19
Radiant warmer ...................................................................................................................20
Intensity selection of the radiant warmer .............................................................................21
Exceeding the maximum intensity selection..........................................................................22

Instructions for Use Neonatal Intensive Care System VARIOTHERM REA-KCE
D2002_01.doc 3/39
Warnings for use..................................................................................................................23
General................................................................................................................................23
Height adjustment facility.....................................................................................................23
Conductive under-pad heating.............................................................................................23
Radiant warmer ...................................................................................................................24
Upgrade items and accessories.......................................................................................25
Safety and alarm functions................................................................................................26
Conductive under-pad heating.............................................................................................26
Radiant warmer ...................................................................................................................28
Cleaning and disinfection..................................................................................................32
Waste disposal.....................................................................................................................32
Maintenance..........................................................................................................................33
System check of the conductive under-pad heating............................................................34
Extended functional test of the radiant warmer ...................................................................35
Technical data......................................................................................................................37
Transport and storage .........................................................................................................37
Ambient requirements..........................................................................................................37
General data........................................................................................................................37
Software version..................................................................................................................38
Operating/Performance data ...............................................................................................38
General ............................................................................................................................38
Conductive under-pad heating.............................................................................................38
Radiant warmer .................................................................................................................38
Classification .......................................................................................................................39
Standards ............................................................................................................................39
Registration .........................................................................................................................39

Instructions for Use Neonatal Intensive Care System VARIOTHERM REA-KCE
D2002_01.doc 4/39
Normal use
The resuscitation and intensive care system VARIOTHERM is used for postnatal care and resuscitation,
warming care, oxygen therapy as well as intensive care of infants up to 12 kg weight. It is laid out for
continuous operation and conforms to the "Particular requirements for the safety of blankets, pads and
mattresses, intended for heating in medical use EN-60601-2-35" as well as the "Particular requirements for
the safety of infant radiant warmers EN 60601-2-21".
General safety instructions
The user must be thoroughly acquainted with this instruction for use. The resuscitation and intensive care
system must only be used under medical supervision by qualified instructed persons who are acquainted
with the use and risks of conductive warming devices and radiant warmers for infants.
If the device shall be used for another purpose than the normal use described above, this must not be done
without our written consent.
In order to guarantee the safe operation, the resuscitation and intensive care system should be subject to
regular preventive maintenance measures by authorized qualified persons. For normal operating conditions
we recommend yearly preventive maintenance intervals whereas under unfavourable ambient conditions
and in case of high-duty use half-yearly intervals should be observed. We can only be held responsible for
the safety features of this device when maintenance and modifications are carried out by authorized
qualified persons, by using original spare parts.
Transport and storage
For transport and storage the following conditions should be observed:
Temperature: 0°C to 70°C
Relative air humidity: 15 % to 95 %
Atmospheric pressure 900 to 1100 hPa
The device must not be exposed to strong vibrations.
Ambient requirements
The device can be used under the following operation conditions:
Temperature: 18°C to 30° C
Relative air humidity: 15 % to 95 %
Atmospheric pressure: 900 to 1100 hPa
This device is not suitable for the use in explosion-hazardous areas.
When using HF-surgery devices are applied, it should be observed that the under-pad heating consists of
electrically conductive material and that it is earthed.
Mobile telephones may interfere the function of electro-medical devices. Therefore no mobile telephones
should be used within a distance of 10 meters around the device.
It has to be considered that other heating sources, fans and cold walls may change the effect of the device.
Therefore a distance of 1 m should be kept clear and the bassinet should be protected from direct sunlight.
Furthermore the device should not be placed in draughts (e.g. air condition) and at windows. Fluids and
inflammable agents must not be brought into touch with the radiant warmer. In order to avoid the risk of fire
there must not be any inflammable material (e.g. curtains) within an area of 70 cm around the radiant
warmer.

Instructions for Use Neonatal Intensive Care System VARIOTHERM REA-KCE
D2002_01.doc 5/39
Structure and operating principle
The resuscitation and intensive care system VARIOTHERM REA-KCE consists of the following components
assemblies:
1. Mobile trolley
The solid trolley supports the complete device and is mobile on four antistatic swivel castors with total kick-
stop. Additional bumpers are provided to protect device and furniture from damages.
1.1 Height adjustment facility
The working level can be adjusted by means of foot pedals, i.e. the complete device is moved electro-
motively. The foot pedals can be arranged at the front or at one of the two sides of the device. As an option
pedals can be provided both at the front and at the side.
1.2 Electrical distribution
Take-off sockets ~ 230 V and the low voltage transformer of the under-pad heating are arranged below the
rear-side of the trolley. Furthermore the power for infrared radiant warmer and the take-off sockets (5.1.) is
supplied from here.
1.3 Upgrade items
A shelf (order No. WY 2060) or drawers (order No. WY 2061) are available for storing necessary material.
Furthermore an oxygen cylinder up to 10 l can be fixed at the trolley.
1
1.1
1.2
1.3
2
3
2.1
4
5
5.1
5.3
5.2
6
1. Mobile trolley
1.1. Height adjustment
facility
1.2. Electrical distribution
1.3. Upgrade items
2. Bassinet
2.1. Tilting facility
3. Conductive under-pad
heating
4. Wall system
5. Frame system
5.1. Take-off sockets
5.2. Swivel facility for the
radiant warmer
5.3. Upgrade items/
accessories
6. Infrared radiant warmer