Weyer Variotherm REA-KCE User manual

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Herrenhöhe 4 >D-51515 Kürten/Germany
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Variotherm REA-KCE 2043/ _________
Under-pad heating 2010/ _________
Radiant warmer 2200/ _________
Year of manufacture:
______________
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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

Instructions for Use Neonatal Intensive Care System VARIOTHERM REA-KCE
D2002_01.doc 6/39
2. Bassinet
The bassinet is arranged on the trolley, attached to a tilting device. Raised sides prevent the infant from
trundling out of the bassinet. A heating plate included in the bottom of the bassinet warms up a gel pad. This
gel pad conducts the accumulated heat to the patient.
2.1 Tilting facility
The tilting device under the bassinet allows tilting positions from + 20° to-10°.
3. Conductive under-pad heating
The heating plate, which is included in the bassinet, is operated by safety low-voltage. The electronically
controlled heating-plate temperature can be selected from 30°C to 38,5°C and is conducted to the patient
through the gel pad.
Temperature deviations, system faults and power failure are indicated both visually and audibly. The
selected bassinet temperature (selected value) as well as the actual bassinet temperature (actual value) is
displayed permanently.
This device does not give any indication as to the patient's body temperature. Therefore the effect of the
selected temperature on the patient must be checked in regular intervals.
4. Wall system
The four walls protect the infant from draught and falling from the bassinet. For better accessibility during
treatment the front wall and the two side walls can be folded down with one hand. Two additional safety side
walls are provided which can be retracted into the bassinet if necessary.
Cables and tubes are conveyed through the silicone tube guidings in the rear wall and the open corners of
the wall system.
5. Frame system
The frame supports the infrared radiant warmer and is used for fixing upgrade items and accessories.
5.1 Take-off sockets
2 take-off sockets 230 V are provided in the traverse spar of the frame system, supplying power for
electrical additional devices.
5.2 Swivel facility for the radiant warmer
This facility allows to swivel the radiant warmer to both sides. In side position the radiation is still focussed to
the patient thus preventing him from becoming hypothermic. Thus the area above the patient is kept clear
for examination, X-ray, and phototherapy.

Instructions for Use Neonatal Intensive Care System VARIOTHERM REA-KCE
D2002_01.doc 7/39
5.3 Upgrade items / accessories
Various accessories, e.g. instrument rails, shelves, flowmeter, compressed air and vacuum devices as well
as additional devices can be mounted at the frame system. The power for electrical devices, e.g. ventila-
tors, monitors, Apgar timer etc. is supplied via the take-off sockets in the traverse spar of the frame system.
For the adaptation of additional devices the "General requirements for the safety of medical electrical
systems EN 60601-1-1 + Supplement A1" must be observed.
6. Infrared radiant warmer
The radiant warmer with swivel facility, which is arranged above the bassinet, is used for pre-warming the
bassinet and the walls and for maintaining the patient's body temperature during treatment. It generates
infrared radiant heat in the range of 0.8 to 10 micrometer (µm). This radiant heat is not visible and is very
well absorbed by the skin without injuring the patient's eyes.
The ceramic heating elements do not scale and are not affected by liquid splashes.
For dazzle-free illumination of the bassinet two light sources are integrated in the radiant warmer.
The radiation intensity effective for the patient is selected at the operating unit of the radiant warmer, de-
fined in mW/cm². The emitted radiation intensity (actual value) is displayed and deviations from the
selected value are indicated visually and audibly.
It must be emphasized that the radiant warmer does not give any indication as to the patient's body tempe-
rature. Therefore the effect of the selected radiation intensity on the patient must be checked in regular
intervals.
Under certain circumstances radiation intensities above 10 mW/cm² might bring the patient in a hyper-
thermic condition. Therefore the radiant warmer provides a safety feature, which in case of intensities above
10 mW/cm² emitted for more than 15 minutes, will reduce the output to a safe value while an audible alarm
sounds. The selected higher value can be reactivated by pushbutton for further 15 minutes. For certain
applications, which are described more detailed in chapter "Functions and alarms" (from page 16) and "Use"
(from page 18) this safety and alarm feature can be deactivated by a conscious action.
In order to prevent the risk of fire and accident the residual heat of the heating elements is displayed until
the device has cooled off.

Instructions for Use Neonatal Intensive Care System VARIOTHERM REA-KCE
D2002_01.doc 8/39
Start-up and functions, functional test
Qualified persons only should install and start-up the device and instruct user's personnel.
When installing 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.
Prior to start-up all components of the device must be checked for correct and secure position.
Clean the device in cold condition according to chapter "Cleaning and Disinfection" (page 32).
The functions of the moving mechanical components should be checked as follows:
Move the bassinet to the lowest and highest position by means of the foot pedals (1.1). Make sure that no
items or devices are placed within in the range of the height adjustment.
1.1
2.2
5.2
4.1
4.1
4.2
B
B
5.2.1
1.3
5.3

Instructions for Use Neonatal Intensive Care System VARIOTHERM REA-KCE
D2002_01.doc 9/39
Unlock the catch (2.2) below the frontside of the bassinet by pulling and tilt the bassinet in both directions.
Check in several positions whether the catch (2.2) locks automatically when being released and whether the
bassinet is fixed in this position.
For checking the wall functions unlock the walls (4.1) and (4.2) by lifting and fold them down. They must
latch securely again simply by folding up.
Both the under-pad heating and the radiant warmer have a 9V battery which is included in the scope of the
device. The battery compartment Bfor the under-pad heating is placed below the bassinet and the one for
the radiant warmer at the rear bottom side of the warmer, beside the type label.
After pulling and 90° turning of the latch (5.2.1) the radiant warmer can be moved to the right-hand or left-
hand side. After checking this function, turn the catch (5.2.1) back by 90° and move the radiant warmer to
normal position until the catch locks.
If upgrade items or accessories are mounted at the device (e.g. 1.3 and 5.3) these must be checked for
secure position.
Before start-up make yourself acquainted with the following control and display elements of the device.

Instructions for Use Neonatal Intensive Care System VARIOTHERM REA-KCE
D2002_01.doc 10/39
Functions of the under-pad heating
3.1 Button "Alarm reset"
3.2 Button "Unlocking of extended temperature range" (30°C to 35°C and 37°C to 38,5°C)
3.3 Button "System check"
3.4 Button "Heating On-Off"
3.5 Knob "Temperature selection"
3.6 Display "Selected temperature"
3.7 Display "Actual temperature"
3.8 Pilot lamp (green) "Heating power". In normal operation the lamp lights intermittently
3.9 Warning lamp (yellow) "Temperature selection below 35°C"
3.10 Warning lamp (yellow) "Temperature selection above 37°C"
3.11 Warning lamp (red) "Power failure"
3.12 Warning lamp (red) "Deviation between selected and actual temperature exceeding 1°C"
3.13 Warning lamp (red) "Bassinet temperature exceeding 40°C"
3.14 Warning lamp (red) "Heating-up period"
Start-up of the under-pad heating
First of all make sure that the device is connected to the mains supply.
Switch-on the conductive under-pad heating with button (3.4). Now a self-test checks the major displays and
alarm functions. The alarm tone sounds and all displays light up for approx. 2 seconds. Both the selected
temperature display (3.6) and the actual temperature display (3.7) indicate the value 88.8.
Check during these 2 seconds whether all displays, pilot lamps and the alarm tone are functioning.
If the self-test is finished without faults, now the temperature of 37.0°C is offered in the temperature
selection display (3.6). The actual temperature display indicates SET and the selected temperature display
(3.6) indicates 37.0°C. Both displays flash and an intermittent tone sounds.
Now the offered temperature of 37.0° can either be confirmed by pushing button (3.1) or adjusted by the
temperature selection knob (3.5). After confirming by button (3.1.) or temperature adjustment the alarm tone
extinguishes.
Temperature selection
The temperature selection consists of two sections, i.e. the "standard" temperature range (35°C to 37°C)
and the "extended" temperature range (30°C to 35°C and 37°C to 38.5°C).
3.1 3.2 3.10 3.6 3.7 3.13 3.3 3.4
3.4
3.8 3.9 3.5 3.14 3.11 3.12