Weyer CERAMOTHERM 1000 User manual

GmbH
Herrenhöhe 4 D-51515 Kürten/Germany §++49 2207-9698-0 ¬++49 2207-4750 E-mail: [email protected]
CERAMOTHERM WY1100/ _________
WY1200/ _________
Year of manufacture _________
Software 1.43
Instruction for use
Radiant warmer
DFSBNPUIFSN 1000
D2027_02

Instruction for use Radiant Warmer CERAMOTHERM 1000
D2027_02 2/25
Normal use.................................................................................................................................3
General safety instructions....................................................................................................3
Transport and storage.............................................................................................................3
Ambient requirements.............................................................................................................3
Mounting / Installation.............................................................................................................4
Structure and operating principle ........................................................................................5
Start-up .......................................................................................................................................5
Functions .................................................................................................................................6
First switch-on...........................................................................................................................7
Function processes and alarms................................................................................................8
End of operation .......................................................................................................................8
Use...............................................................................................................................................9
Warnings for use.......................................................................................................................9
General............................................................................................................................................... 9
Adjustment ......................................................................................................................................... 9
Infra-red radiation............................................................................................................................... 9
Fire hazard......................................................................................................................................... 9
Radiant warmer ......................................................................................................................10
Intensity selection.............................................................................................................................10
Maximum intensity ...........................................................................................................11
Mounts....................................................................................................................................12
Static arrangement to the patient pad..............................................................................................12
Flexible arrangement to the patient pad ..........................................................................................12
Height-adjustable mounts *..............................................................................................................14
Mobile radiant warmers * ................................................................................................................. 15
Safety and alarm functions..................................................................................................16
Cleaning and disinfection.....................................................................................................17
Cleaning agents and disinfectants..........................................................................................17
Cleaning and disinfecting........................................................................................................17
Waste disposal........................................................................................................................17
Maintenance.............................................................................................................................18
Spare and wear parts .............................................................................................................18
Technical data.........................................................................................................................19
Transport and storage ............................................................................................................19
Ambient requirements.............................................................................................................19
General data...........................................................................................................................19
Operating / performance data.................................................................................................19
Classification...........................................................................................................................20
Standards ...............................................................................................................................20
Certification.............................................................................................................................20
Mounts....................................................................................................................................21
Static arrangement to the patient pad..............................................................................................21
Flexible arrangement to the patient pad ..........................................................................................22
Height-adjustable mounts *..............................................................................................................23
Mobile radiant warmers * ................................................................................................................. 24
Declaration of conformity.....................................................................................................25
*Application to babies and defenseless persons under surveillance only

Instruction for use Radiant Warmer CERAMOTHERM 1000
D2027_02 3/25
Normal use
The radiant warmer CERAMOTHERM 1000 is used to maintain the body temperature of patients, especially
infants and children, during postnatal care, baby changing, examination, treatment and care as well as for
pre-warming of patient beds. It is suitable for continuous operation and complies with the "Particular require-
ments 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 radiant warmer must be used
under medical supervision by qualified persons only who are acquainted with the use and risks of infra-red
radiant warmers.
In order to ascertain the safe operation of the infant radiant warmer, we recommend an inspection by
qualified persons once per year.
In order to maintain the nominal state on occasion of the yearly inspection we also recommend a preventive
maintenance by qualified persons.
We can only be held responsible for the safety features of this device when maintenance is carried out by
qualified persons, by observing our instructions and by using original spare parts.
Transport and storage
For transport and storage the following conditions should be observed:
Temperature: 0 to 70°C
Relative air humidity: 15 to 95 %
Atmospheric pressure: 210 to 1100 hPa
The radiant warmer must not be exposed to strong vibrations.
Ambient requirements
The radiant warmer can be used under the following operation conditions:
Temperature: 18 to 30°C
Relative air humidity: 15 to 95 %
Atmospheric pressure: 860 to 1100 hPa
This radiant warmer is not suitable for the use in explosion-hazardous areas.

Instruction for use Radiant Warmer CERAMOTHERM 1000
D2027_02 4/25
Mounting / Installation
Depending on the supplied model the radiant warmer CERAMOTHERM 1000 can be mounted at the wall or
ceiling by qualified persons by observing our instructions for installation. The radiant warmer can also be
mounted at a mobile stand. Please refer to the remarks for the individual mounts on pages 12 to 15 and 21
to 24.
For installation it has to be considered that heating or air conditioning devices can change the effect of the
radiant warmer. Therefore a distance of 1 m should be kept clear. This distance should also be kept between
two radiant warmers. Furthermore the radiant warmer should not be placed in draughts, at cold walls or
windows as well in direct sunlight.
In case of radiant warmers with flexible arrangement to the patient pad take care that no items are placed
within the adjusting/moving radius of the radiant warmer.
No fluids must be placed above the radiant warmer which in the case of fault might flow into the device.
For fire prevention a distance of min. 50 cm must be kept clear between the radiant warmer and any
inflammable material (e.g. curtains), under consideration of the moving radius of the radiant warmer in case
of an adjustable mount.
The radiant warmer provides an electronical control which allows to exactly select the radiation intensity
emitted to the patient pad. The selection is decisively dependent from the distance between the radiant
warmer and the patient pad. Therefore the mounting height must be determined with corresponding care.
The factory distance calibration is obvious from the sticker which is placed between the rear faceplate and
the device housing. If the radiant warmer shall be mounted at a different distance, this should only be done
with the consent of the manufacturer or authorized supplier because in that case the device must be
recalibrated to the new distance.
For ergonomical reasons different standard respectively operating distances apply for the various mounts.
The corresponding distance as well as the weights and torques can be taken from the charts below the
individual mounts, pages 21 to 24.
A safety distance of 650 mm between the bottom line of the radiant warmer and the patient pad must be
maintained. Height-adjustable wall and ceiling mounted radiant warmers must be mounted in a way that at
highest patient level and lowest position of the radiant warmer a safety distance of 650 mm is maintained.
When calculating the mounting height the standard respectively operating distance plus the thickness of the
pad must be considered in order to verify the correct distance to the patient.
A direct installation to the electrical mains must only be done by a qualified electrician.

Instruction for use Radiant Warmer CERAMOTHERM 1000
D2027_02 5/25
Structure and operating principle
The radiant warmer is used for pre-warming the patient pad and for maintaining the patient's body
temperature during the treatment. It generates infra-red radiation energy which is absorbed by the skin an
converted into body heat. The radiation spectrum is in the far non visible infra-red range. The radiation
energy does not injure the patient's eyes.
The ceramic heating elements do not scale and are not affected by liquid splashes.
For dazzle-free illumination of the patient pad two light sources are integrated in the radiant warmer.
The radiation intensity emitted to the patient pad is selected defined in mW/cm². The selection is
permanently displayed. System faults and power failure are alerted visually and audibly.
The intensity display of the radiant warmer does not give any indication as to the patient's body temperature.
Therefore the patient's temperature must be checked in regular intervals or monitored.
Under certain circumstances radiation intensity above 10 mW/cm² may bring an infant in a hyperthermic
condition. Therefore after 15 minutes the intensity is automatically reduced to a safe value while a visual and
audible alarm is released. The operator may now reduce the intensity selection or confirm the high intensity
by pushbutton for the next 15 minutes. For certain applications this safety function can be switched-off
temporarily by a conscious action, refer to chapter "Function processes and alarms" (page 8) and "Use"
(page 11).
Start-up
Qualified persons only should install and start-up the device and instruct the user's personnel.
Before start-up, the device as well as the mount must be checked for correct and secure position. Check
also the function of the adjusting elements (if available) according to chapter "Mounts" (pages 12 to 15).
The radiant warmer must be equipped with a 9V battery which is included in the delivery of the device. The
battery compartment is placed at the bottom side of the warmer, beside the nameplate.
Now clean the device in cold condition according to chapter "Cleaning and disinfection" (page 17).
Before switching-on the radiant warmer make yourself acquainted with the following control elements and
displays.

Instruction for use Radiant Warmer CERAMOTHERM 1000
D2027_02 6/25
Functions
10
20
30
?
+-
Intensity
mW
cm²
Test / Alarm
>10
mW
cm²
DFSBNPUIFSN
13 12 43 21
11 10 7 6 5
1 Button illumination On / Off.
2 Button heating On / Off.
3Label next maintenance.
4 Alarm reset button:
a.) By pushing the button the audible alarm of the safety function >10 mW/cm² is reset and the radiant
warmer proceeds heating at the selected intensity for further 15 minutes.
b.) By pushing the button for approx. 3 seconds the safety function >10 mW/cm² is switched-off which
is confirmed by two short tones and the yellow warning lamp (10) flashes. The safety function is
reactivated by pushing the button again for approx. 3 seconds which is confirmed by one short
tone.
5 Pilot lamp (green) illumination.
6Pilot lamp (green) heating power.
7 Warning lamp (red):
a.) Flashing during normal operation: The battery capacity for the power failure alarm is below
10 minutes.
b.) Lighting in connection with a permanent alarm tone: Power failure. The power line of the radiant
warmer is interrupted. The alarm can be reset by switching-off the heating (2). When the power line
has been reinstalled, the heating must be switched on again.
8 Idle
9 Idle
10 Warning lamp (yellow) >10mW/cm²:
a.) Lighting: Intensity selection above 10 mW/cm². Increased attention must be given to the patient.
After 15 minutes the radiation intensity is automatically reduced to 10 mW/cm².
b.) Flashing: The safety function >10mW/cm² has been switched-off and the radiant warmer
permanently generates the selected radiation intensity. The patient temperature must be securely
surveyed.
11 Pilot lamp (green) heating power. Lighting when heating power is available. When the lamp lights, the
radiant warmer will heat-up, when it does not light, the radiant warmer will cool-off.
12 Intensity selection display: LED-spot field.
13 Intensity selection knob with 15 increments.

Instruction for use Radiant Warmer CERAMOTHERM 1000
D2027_02 7/25
First switch-on
First of all make sure that the radiant warmer is connected to the power supply. The pilot lamp for the safety
cut-off at the bottom side of the device indicates the readiness for operation.
Select an intensity of 10 mW/cm² with knob (13). The selection is indicated as LED-spot in display (12).
The green pilot lamp for the heating power (11) flashes according to the intensity selection, i.e.:
• Low radiation intensity = short flashes
• High radiation intensity = long flashes.
Depending on the ambient temperature the ceramic heating elements require approx. 4 to 6 minutes until the
selected intensity of 10 mW/cm² is reached.
11
6
2
1
5
Switch-on the light with button (1). The green pilot lamp (5) and the
illumination of the patient area light.
Switch-on the heating with button (2). The green pilot lamp (6) lights.
A self-test is performed. A tone sounds and all displays light-up fo
r
2 seconds.
Check during the 2 seconds whether all displays light up and the
tone sounds.
When the self-test is finished successfully, the radiant warmer starts
heating-up. The green pilot lamp for heating power (11) lights.

Instruction for use Radiant Warmer CERAMOTHERM 1000
D2027_02 8/25
Function processes and alarms
Heating-up
After switch-on with button (2) the device starts heating. The desired radiation intensity can be selected with
knob (13) and is indicated as LED spot in display (12). Depending on the selection and the ambient
temperature the heating-up time will be between 3 and 15 minutes.
Normal operation up to 10 mW/cm²
Radiation intensity up to 10 mW/cm² cannot cause any problems and under normal conditions it is sufficient
to maintain the body temperature of healthy normal-weight infants.
Increasing the radiation intensity
By turning the knob (13) clockwise the radiation intensity is increased. Each selection increment is confirmed
by a short tone. The intensity selection is indicated as LED spot in display (12).
Maximum intensity
Depending on the device model and the calibrated distance to the patient pad a maximum intensity of 14 to
30 mW/cm² can be selected. In case of a selection which the radiant warmer is unable to reach, the
maximum intensity is indicated by a permanent LED spot in the intensity selection display (12). The un-
reachable selection is indicated by a flashing LED spot.
Operation above 10 mW/cm² with safety function
Under certain circumstances radiation intensity above 10 mW/cm² may bring an infant in a hyperthermic
condition. An intensity selection above 10 mW/cm² is indicated by warning lamp (10). After 15 minutes the
intensity is automatically reduced to 10 mW/cm². When the high intensity shall be continued, this must be
confirmed by pushbutton (4).
Alarm:
In the intensity selection display (12) the LED spot for the selection and the LED spot for 10 mW/cm² flash
alternately and a short alarm tone sounds in intervals of 2 seconds. The alarm can be reset for 15 minutes
by pushbutton (4). Now the radiant warmer will emit the selected intensity for further 15 minutes. The yellow
warning lamp (10) lights and indicates that the safety function >10 mW/cm² is activated.
Operation above 10 mW/cm² without safety function
Provided that the patient's temperature is surveyed, the safety function can be switched-off temporarily by
pushing the button (4) for approx. 3 seconds. A special warning is expressed regarding the danger of
hyperthermia in case of operation at an intensity above 10 mW/cm²!
Alarm:
The switch-off of the safety function with button (4) is confirmed by two short tones and the warning lamp
(10) flashes.
The reactivation with button (4) is confirmed by one short tone. The warning lamp (10) lights in case of an
intensity selection above 10 mW/cm².
When the radiant warmer is switched-on anew, the safety function is always activated.
Reducing the radiation intensity
By turning the knob (13) anti-clockwise the radiation intensity is reduced. Each selection increment is
confirmed by a short tone. The intensity selection is indicated as LED spot in display (12). Depending on the
amount of intensity reduction the cooling-off will take 1 to 4 minutes.
End of operation
Switch-off the heating with button (2). The pilot lamp for the safety cut-off at the bottom side of the device
lights.

Instruction for use Radiant Warmer CERAMOTHERM 1000
D2027_02 9/25
Use
Warnings for use
General
• The radiant warmer is not suitable for the use in explosion-hazardous areas.
• The ambient conditions for the radiant warmer must in no case be influenced by any warming or air
condition devices.
• Do not place any medical drugs or infusion fluid above the radiant warmer or within irradiated area.
• Do not place anything on top of the radiant warmer.
Adjustment
• Take care that no items are placed within the adjusting/moving radius of the radiant warmer.
• The mobile stand (if available) must be moved in lowest position only.
• When using height-adjustable radiant warmers a safety distance of 650 mm to the patient pad must be
maintained.
• Height-adjustable radiant warmers must be applied to babies and defenseless persons under
surveillance only.
Infra-red radiation
• Under unfavourable circumstances the safety guard of the radiant warmer can reach a temperature of
above 85°C. Therefore during operation it should be avoided to touch the safety guard or the top of the
radiant warmer. Take care that infants or children cannot grip into the safety guard.
• Do not place any dark metal items within the field of radiation, as after a longer period they can become
dangerously hot.
• The intensity display of the radiant warmer does not give any indication as to the patient's temperature.
• The patient's temperature must be checked in regular intervals or monitored.
• Sunlight, draught, cold walls and windows in direct ambience to the radiant warmer will influence the
patient's temperature balance negatively.
• Below a distance of 650 mm to the patient pad there is a danger of hypothermia or burning injuries for
the patient.
• When a radiant warmer is used in connection with a phototherapy device, it must be observed that
patient temperature and humidity loss can increase.
• The intensity display (12) refers to the patient pad. The radiation intensity reaching the patient's skin is
approx. 4 mW/cm² higher than the displayed value because the distance of the radiant warmer to the
patient's body surface is approx. 10 cm shorter than to the patient pad.
• Under certain circumstances radiation intensity above 10 mW/cm² may bring an infant in a hyperthermic
condition.
• Under radiant warmers the trans-epidermal humidity loss in patients can increase unconsciously.
Fire hazard
• Never use the radiant warmer together with inflammable anaesthesia gas or other inflammable material
and (cleaning) fluids as e.g. alcohol, ether etc.
• Never cover the radiant warmer as long as it is warm as this would impair the convection.

Instruction for use Radiant Warmer CERAMOTHERM 1000
D2027_02 10/25
The radiant warmer generates a long-wave radian
t
heat. The radiation intensity effective to the patien
t
is selected at the display unit of the device.
For dazzle-free illumination of the patient area two
light sources are integrated in the radiant warme
r
which can be switched-on at the display unit, i
f
necessary.
Under unfavourable circumstances the safet
y
guard of the radiant warmer can reach a
temperature of above 85°C. Therefore during
operation it should be avoided to touch the safet
y
guard or the top of the radiant warmer. Take care
that infants or children cannot grip into the safet
y
guard.
Radiant warmer
A safety distance of 650 mm between the bottom line of the radiant warmer and the patient pad must be
maintained.
In case of radiant warmers with adjustable mount (refer pages 12 to 15 and 22 to 24) unfasten the fixing
facility and move the radiant warmer into the desired position. Use the two handles and do not touch the
safety guard. Afterwards fasten the fixing facility again.
Take care that no items are placed within the adjusting/moving radius of the radiant warmer.
Intensity selection
10
20
30
?
+-
Intensity
mW
cm²
Test / Alarm
>10
mW
cm²
DFSBNPUIFSN
13 12 43 21
11 10 7 6 5
After switch-on the heating with button (2), the desired radiation intensity can be selected with knob (13). The
selection is indicated as LED-spot in display (12). Now it takes about 3 to 15 minutes until the selected
intensity is reached.
Intensity
selection Intensity selection display
Light source Light source
Heating element(s)