Weyer Variotherm REA-KCE User manual

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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
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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
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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

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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.

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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.

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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
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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
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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

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Within the standard temperature the selected temperature can be adjusted by knob (3.5) in increments of
0.1°C. Each adjustment is confirmed by a tone. The selected temperature is increased by turning the knob
clockwise and reduced by turning it anti-clockwise.
Within the extended temperature range the selected temperature can be adjusted by pushing the unlocking
button (3.2) and simultaneous turning knob (3.5). During this procedure the warning lamps (3.9) and (3.10)
light. After the adjustment the button (3.2) can be released. In case of a temperature selection below 35°C
the warning lamp (3.9) lights and in case of a temperature selection higher than 37°C the warning lamp
(3.10) lights.
Heating up from cold state
When the under-pad heating is switched-on at a bassinet temperature more than 5°C lower than the most
recently selected temperature, the device reacts as described in chapter "Start-up of the under-pad heating".
A selected temperature of 37°C is offered which can either be confirmed or adjusted.
The audible low temperature alarm is deactivated for a period of 30 minutes. During this period the warning
lamp (3.14) flashes. When it extinguishes, the normal operating state is reached and the audible low
temperature alarm is activated.
Heating-up from partly cooled state
When the under-pad heating is switched-on at a bassinet temperature min. 1°C and max. 5°C lower than
the most recently selected temperature, this temperature will be adopted automatically.
All alarms are activated, including the audible low temperature alarm. The low temperature alarm, however,
can be reset by button (3.1) for a period of 15 minutes. The warning lamp (3.14) flashes and indicates
normal operating mode only after 30 minutes from switching-on.
Repeated start from warm state
When the under-pad heating is switched-on at a bassinet temperature max. 1°C lower or higher than the
most recently selected temperature, the device will operate in normal mode immediately. All alarms are
activated.
Alarms
Deviation between selected and actual temperature exceeding 1°C:
The following alarms are released:
•Red warning lamp (3.12) flashes
•Actual temperature display (3.7) flashes
•An intermittent alarm tone sounds
By pushing button (3.1) the intermittent tone is deactivated for a period of 15 minutes, the warming lamp
(3.12) lights permanently.
If the deviation between selected and actual temperature is lower than 1°C, the warning lamp (3.12) and the
audible alarm extinguish.
Increased attention has to be given to the patient when the above mentioned alarms are released.
During heating-up period from cold state the audible low temperature alarm is deactivated for a period of
30 minutes (see chapter "Heating-up from cold state").

Instructions for Use Neonatal Intensive Care System VARIOTHERM REA-KCE
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Bassinet temperature exceeding 40°C:
The following alarms are released:
•Red warning lamp (3.13) flashes
•Selected temperature display (3.6) and actual temperature display (3.7) flash
•A permanent alarm tone sounds
Furthermore at a temperature exceeding 40°C the heating is cut-off automatically.
This alarm relates to a device failure. As long as the bassinet temperature is above 40°C, the alarm tone
cannot be reset with button (3.1).
Switch-off the under-pad heating with button (3.4) and make sure that the patient is cared for in another
way. If this is not possible, place a foam pad min. 2 cm thick or a woollen blanket between patient and gel
pad in order to avoid that heat is withdrawn from the patient by the cooling gel pad.
If in case of an alarm the under-pad heating is switched-off with button (3.4), the residual actual temperature
is displayed. The device is automatically switched-off when the actual temperature has dropped below 35°C.
Insufficient capacity of power failure alarm battery:
The following alarms are released:
•The displays (3.6) und (3.7) indicate Lo + bAt every 10 seconds
•The warning lamp (3.11) flashes
•A short alarm tone sounds every 10 seconds
After changing the battery the alarms are reset automatically.
Power failure alarm:
The following alarms are released:
•Warning lamp (3.11) lights
•A permanent alarm tone sounds
Switch-off the under-pad heating with button (3.4) and make sure that the patient is cared for in another
way. If this is not possible, place a foam pad min. 2 cm thick or a woollen blanket between patient and gel
pad in order to avoid that heat is withdrawn from the patient by the cooling gel pad.
Temperature sensor alarm:
The following alarms are released:
•The displays (3.6) and (3.7) alternately indicate Err + Pt + Err XXX .
XXX refers to an error code.
•A permanent alarm tone sounds
The alarm tone cannot be reset with button (3.1).
Switch-off the under-pad heating with button (3.4) and make sure that the patient is cared for in another
way. If this is not possible, place a foam pad min. 2 cm thick or a woollen blanket between patient and gel
pad in order to prevent that heat is withdrawn from the patient by the cooling gel pad.

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System check
The system check serves to test the functions of the control unit. It is released by pushing the button (3.3).
The following functional tests are performed:
1. Lamp and alarm test (approx. 2 seconds)
2. All displays are switched-off (approx. 1 second)
3. The selected value display (3.6) alternately indicates 37.0 and ChE
The actual temperature display should indicate a value of 37.0°C ± 0.1°C. If the deviation is larger
than ±0.1°C, the control system is not adjusted correctly.
If there are deviations in one of the mentioned functions, a safe operation is no longer guaranteed and the
device must be checked by authorized qualified persons without delay.
End of operation
The conductive warming device is switched-off with button (3.4). After switching-off all displays extinguish,
with the exception of the actual temperature display. The device is automatically switched-off when the
actual temperature has dropped below 35°C.

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Functions of the infrared radiant warmer
6.1 Button "Illumination On-Off".
6.2 Button "Heating On-Off.
6.3 Label indicating next maintenance.
6.4 Multifunctional button:
a.) Resets the audible high intensity
alarm for 1 minute.
b.) Resets the audible low intensity alarm
for 15 minutes.
c.) Pushing the button for more than
3seconds deactivates the 15-minutes
alarm and the automatic heating
capacity reduction > 10 mW/cm²,
which is confirmed by two short tones.
The function is reactivated by pushing
the button for more than 3 seconds,
which is confirmed by one short tone.
d.) Button for "Extended functional test"
(page 35).
6.5 Pilot lamp (green): Illumination.
6.6 Pilot lamp (green): Heating.
6.7 Warning lamp (red): Double function:
a.) When the lamp flashes during normal
operation, the capacity of the power
failure alarm battery is below
10 minutes.
b.) When the lamp lights in connection
with an permanent alarm tone, the
power supply is interrupted. The
alarm can be reset by switching-off
the heating with button (6.2). When
the power supply is reinstalled, the
heating must be switched-on again.
6.10 Warning lamp (yellow) > 10 mW/cm²,
double function. At an intensity selection
between 12 and 30 mW/cm² it indicates
that increased attention must be
extended to the patient.
a.) When it lights permanently, the
heating capacity will be reduced
automatically when an intensity above
10 mW/cm² is emitted to the bassinet
for more than 15 minutes.
b.) When it flashes, the automatic
heating capacity reduction is
deactivated, and an increased
attention must be extended to the
patient.
6.11 Pilot lamp (green). It always lights when
the heating elements are energized, i.e.
when the lamp lights, the radiant warmer
will heat-up, when it does not light, the
radiant warmer will cool off.
6.12a LED for selected intensity and
15-minutes alarm with automatic heating
capacity reduction.
6.12b Bar graph 2-30 mW/cm² for the actual
intensity emitted to the bassinet and
residual heat after switching-off.
6.12a+b Combination LED / Bar graph, display of
various functions and alarms.
6.13 Knob with 15 increments for intensity
selection.
6.13 6.12b 6.4 6.3 6.2 6.1
6.12a 6.11 6.10 6.7 6.6 6.5

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Switch-on the light with button (6.1). The pilot lamp (6.5)
and the light tubes in the radiant warmer light.
When switching-on the heating with button (6.2), the
device always performs a short self-test. The alarm tone
sounds and all displays and pilot lamps light up for
2seconds.
Check during these 2 seconds whether all displays,
pilot lamps and the alarm tone are functioning.
The self-test is finished automatically and the device
starts heating-up. This is obvious from the pilot lamp for
the heating power (6.11), which initially lights perma-
nently. The selected radiation intensity is indicated as a
spot in the LED (6.12a). Now select an intensity of
10 mW/cm² with knob (6.13). The bottommost LED-field
of bar graph (6.12b) flashes until the intensity has
reached the selected value.
First start of the radiant warmer
First of all make sure that the device has been connected to the power supply. The pilot lamp for the safety
cut-off beside the battery compartment indicates that the unit is ready for operation.
The ceramic heating elements require approx. 4 to 6 minutes until they have reached the selected intensity
of 10 mW/cm².
The radiation intensity emitted by the ceramic heating elements is displayed in the right field of bar graph
(6.12b). At a selected intensity of 10 mW/cm the LED´s 4 + 6 + 8 mW/cm² light-up progressively. The
radiant warmer has reached the selected radiation intensity when the topmost field of the bar graph (6.12b)
has reached the LED spot of display (6.12a). The pilot lamp for heating power (6.11) now lights inter-
mittently according to the emitted radiation intensity.
For first start and after a longer time of non-use the "Extended functional test" (page 35) should be
performed which will take approx. 20 minutes.

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Functional processes and alarms
Display
Sequence of functions
Alarm
Heating-up
After switching-on the device with
button (6.2) the heating elements will
warm up. The desired radiation
intensity (6.12) can be selected with
knob (6.13). The heating-up state is
obvious from the actual intensity
display (6.12b). Depending on the
selected intensity and the ambient
temperature the heating-up time will
be between 3 and 15 minutes.
The bottommost field of the actual
intensity bar graph (6.12b) flashes
until the selected intensity (6.12a) is
reached. During the heating-up period
an audible alarm will only be released
after 15 minutes. If this is the case,
low ambient temperature or a failure
in the heating system could be the
reason. The audible alarm can be
reset for 15 minutes with button (6.4).
Normal operation up to 10 mW/cm²
Radiation intensity up to 10 mW/cm²
cannot cause any problems and
under normal conditions it is suffi-
cient to maintain the body tempera-
ture of healthy normal-weight infants.
During normal operation the topmost
field of bar graph (6.12b) is at the
same vertical position as the LED for
selected intensity (6.12a).
No alarms
Increasing the radiation intensity
By turning the knob (6.13) clockwise
the radiation intensity will be
increased. Each adjustment is
confirmed by a short tone. The
selected intensity is indicated in LED
(6.12a). Corresponding to the
heating-up state, the bar graph
(6.12b) indicates the emitted radiation
intensity. The selected intensity is
reached when the topmost field of the
bar graph (6.12b) has reached the
topmost spot of LED (6.12a).
When the emitted radiation intensity is
lower than the selected intensity, a
low intensity alarm is released.
However, the device recognizes the
conscious intensity increase and
therefore only a visual alarm is
released by flashing of the bottom-
most field of bar graph (6.12b). When
the new selected intensity is reached,
this flashing field will extinguish. Only
if it will not be reached within 15
minutes, the low intensity alarm will
sound. This audible alarm can be
reset for 15 minutes by button (6.4).
Exceeding the maximum intensity
selection
A maximum intensity of 22 mW/cm²
can be selected. If the intensity knob
(6.13) is set to a value, which the
radiant warmer is unable to reach,
the maximum possible intensity
selection is indicated in LED (6.12a)
by a permanent spot. The (un-
reachable) selected intensity is
indicated in LED (6.12a) by a flashing
spot.
Optical, as described.

Instructions for Use Neonatal Intensive Care System VARIOTHERM REA-KCE
D2002_01.doc 17/39
Display
Sequence of functions
Alarm
Operation above 10 mW/cm² with
15-minutes alarm and automatic
heating capacity reduction.
If exposed to radiation intensity
>10 mW/cm² under certain circum-
stances the infant's body temperature
can increase considerably. An
intensity selection > 10 mW/cm² is
indicated by warning lamp (6.10). If
higher radiation intensity is emitted for
more than 15 minutes, it is auto-
matically reduced to 10 mW/cm². If
the higher intensity should be
continued, this must be confirmed by
pushing the button (6.4).
In LED (6.12a) the spot for the sel-
ected intensity and the spot for
10 mW/cm² flash alternately and a
short alarm tone sounds in intervals of
2seconds. By pushing button (6.4)
the alarm is reset and the selected
intensity is emitted for further
15 minutes.
Normal operation above 10 mW/cm²
Provided that the patient's temp-
erature supervised in another way, for
well-founded reason the automatic
intensity reduction can be deactivated
by pushing button (6.4) for more than
3seconds and it can be reactivated in
the same way. It must be particularly
paid attention to the danger of
hypothermia in case of operation with
intensity above 10 mW/cm²!
Deactivating the automatic intensity
reduction with button (6.4) is
confirmed by two short tones and the
warning lamp (6.10) flashes. The
reactivation of the automatic intensity
reduction with button (6.4) is con-
firmed by one short tone. The warning
lamp (6.10) lights, if a value
>10 mW/cm² is selected.
Reducing the radiation intensity
By turning the knob (6.13) anti-
clockwise the radiation intensity will
be reduced. Each adjustment is
confirmed by a short tone. The
selected intensity is indicated in LED
(6.12a). Corresponding to the cooling-
off state, the bar graph (6.12b)
displays the emitted radiation
intensity. The selected intensity is
reached when the topmost field of the
bar graph (6.12b) has dropped to the
topmost spot of LED (6.12a). The
cooling-off can take 1 to 4 minutes,
depending on the selected intensity.
When the emitted radiation intensity is
higher than the selected intensity, a
high intensity alarm is released.
However, the device recognizes the
conscious intensity reduction and
therefore only a visual alarm is
released by flashing of the topmost
field of bar graph (6.12b). When the
device has cooled-off to the new
selected intensity, this flashing field
will extinguish. If not, the high
intensity alarm will sound after 15
minutes. This audible alarm can be
reset for 15 minutes by button (6.4).
Switching-off the heating
The heating is switched-off with button
(6.2) and the pilot lamp for the safety
cut-off beside the battery compart-
ment lights. For safety reasons the
residual heat emitted by the heating
elements is displayed in bar graph
(6.12b). After cooling off below
2mW/cm² the bar graph is switched-
off automatically.
No alarm

Instructions for Use Neonatal Intensive Care System VARIOTHERM REA-KCE
D2002_01.doc 18/39
Use
Bassinet with wall system
Bring the bassinet into the desired position by means of the foot pedals 1of the height adjustment facility.
Cover the gel pad 2with a thin nappy. Make sure that the nappy is not squeezed between the walls and
that it cannot block the locking system. The front and side walls 4must always close smoothly and latch
securely. The safety walls 3must be inserted in a way that the infant cannot fall from the bassinet. For
better accessibility they can be taken out of their support and inserted again set off by 180°. Thus the walls
are retracted into the bassinet, allowing full access to the patient.
Drainage tubes are conveyed through and the open corners of the front wall, ventilation tubes can be
connected in level position through the tube guidings in the rear wall.
When the under pad heating has reached the steady temperature, place the patient inside the bassinet.
Take care that the walls are folded up so that the patient cannot fall from the bassinet. Take care that no
body parts, tubes and cables are squeezed. After unlocking the tilting device 5incline the bassinet to the
desired position.
2.
3
4
1
5

Instructions for Use Neonatal Intensive Care System VARIOTHERM REA-KCE
D2002_01.doc 19/39
Temperature selection of the under-pad heating
The temperature selection of the under-pad heating
depends on several factors, e.g.:
The patient's temperature must be monitored or checked in regular intervals.
When the under-pad heating is switched-off, the gel pad may cause a reduction of the patient's temperature.
Therefore, if the bassinet shall be used with switched-off under-pad heating, for insulation purposes a foam
pad or woollen nappy, minimum 2 cm thick, must be placed between patient and pad.
In case of an ambient temperature above 30°C and a temperature selection of 30°C there might be released
a high temperature alarm. In that case increase the temperature selection to 32°C or switch-off the under-
pad heating.
Heat is supplied to the patient
Heat is withdrawn from the patient
Heat flow in balance
•Age and maturity of the infant
•Weight
•Does the patient suffer from Hypothermia /
Hyperthermia?
•Are vital functions impaired?
•Which accompanying therapies are applied?
•Is the infant clothed or unclothed?
When selecting the temperature of the conductive
under-pad heating, it must be considered that the
temperature of the gel pad has a direct influence on
the patient (thermal conduction). If the pad
temperature is higher than the patient's temp-
erature, heat is conveyed to the patient. If on the
other hand the pad temperature is lower than the
patient's temperature, heat may be withdrawn from
the patient!
For a mature unclothed infant a bassinet temp-
erature of approx. 36.5°C should be selected. For a
pre-term neonate a temperature of approx. 37° to
37.5°C is recommendable. For clothed infants the
bassinet temperature may be selected 0.5 to 1°C
lower.

Instructions for Use Neonatal Intensive Care System VARIOTHERM REA-KCE
D2002_01.doc 20/39
Radiant warmer
The radiant warmer generates a long-wave infrared
radiation. The radiation intensity effective for the
patient is selected at the operating unit of the radiant
warmer, as described on page 21.
The safety guard of the heating elements can reach a
temperature above 85°C. When taking infants out of
the bassinet, take care that they do not grip into the
safety guard.
The radiant warmer is swivel-mounted. For taking
X-ray or in order to reduce the heat exposure for the
personnel, it can be swivelled to either side. The
radiation keeps focussed on the patient, preventing
him from hypothermia.
In order to swivel the radiant warmer retract the
locking knob of the swivel device and turn it by 90°.
Now the radiant warmer can be swivelled to both
sides. Use the two handles and do not touch the
safety guard.
In order to return the warmer to central position again
turn the locking knob by 90° and move the warmer to
central position until the locking knob latches
automatically.
Take care that no items whatsoever are placed within
the moving radius of the radiant warmer.
For illuminating the bassinet dazzle-free two light
sources are integrated in the radiant warmer, which
can be switched-on at the front-side of the device, if
necessary.