CERAMOTHERM 1000 Instructions for Use sw ver 1.43

Instruction for use Radiant Warmer CERAMOTHERM 1000

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

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Instruction for use Radiant Warmer CERAMOTHERM 1000

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 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 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: Relative air humidity: Atmospheric pressure:

0 to 70°C 15 to 95 % 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: Relative air humidity: Atmospheric pressure:

18 to 30°C 15 to 95 % 860 to 1100 hPa

This radiant warmer is not suitable for the use in explosion-hazardous areas.

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Instruction for use Radiant Warmer CERAMOTHERM 1000

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.

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Instruction for use Radiant Warmer CERAMOTHERM 1000

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.

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Instruction for use Radiant Warmer CERAMOTHERM 1000

Functions 13

4

12

3

2

1

Test / Alarm 30

20

+

?

Intensity

>10 mW cm²

10

DFSBNPUIFSN

mW cm²

11

7

10

6

5

1

Button illumination On / Off.

2

Button heating On / Off.

3

Label 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.

6

Pilot 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.

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Instruction for use Radiant Warmer CERAMOTHERM 1000

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. Switch-on the light with button (1). The green pilot lamp (5) and the illumination of the patient area light.

1 5

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 for 2 seconds.

2

Check during the 2 seconds whether all displays light up and the tone sounds.

6

When the self-test is finished successfully, the radiant warmer starts heating-up. The green pilot lamp for heating power (11) lights.

11

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 High radiation intensity

= short flashes = 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.

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Instruction for use Radiant Warmer CERAMOTHERM 1000

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 unreachable 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.

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Instruction for use Radiant Warmer CERAMOTHERM 1000

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.

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Instruction for use Radiant Warmer CERAMOTHERM 1000

Radiant warmer Intensity selection

The radiant warmer generates a long-wave radiant heat. The radiation intensity effective to the patient is selected at the display unit of the device.

Intensity selection display

For dazzle-free illumination of the patient area two light sources are integrated in the radiant warmer which can be switched-on at the display unit, if necessary. 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.

Light source

Light source Heating element(s)

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 13

4

12

3

2

1

Test / Alarm 30

20

+

?

Intensity

>10 mW cm²

10

DFSBNPUIFSN

mW cm²

11

7

10

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.

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Instruction for use Radiant Warmer CERAMOTHERM 1000

The intensity selection is mainly dependent from the baby's respectively the patient's weight, age, maturity, the anamnesis as well as the ambient conditions. When the radiant warmer is used for long-term care, the radiation intensity has to be selected with utmost care. • The smaller and immature the infant, the higher is the heat demand. • The lower the ambient temperature, the higher is the heat demand. If there is no experience regarding the intensity selection, for an unclothed infant 10 mW/cm² should be selected initially. The body temperature must be checked in regular intervals. If necessary, the intensity selection must be adjusted according to the measured patient temperature. The intensity selection is ideal when neutral thermal conditions are available, i.e. when the patient's body core temperature in relaxed condition is between 36.7 and 37.3°C. Under certain circumstances radiation intensity above 10 mW/cm² may bring an infant in a hyperthermic condition. Therefore the radiant warmer provides the following automatic safety function which is indicated by the yellow warning lamp (10): When radiation intensity above 10 mW/cm² is emitted to the patient pad for more than 15 minutes, the radiation intensity is automatically reduced to 10 mW/cm² and an alarm is released. 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. Check the patient's temperature and reduce the intensity selection if necessary. When the patient shall stay under the radiant warmer at an intensity selection above 10 mW/cm², push button (4). Now the alarm is reset and 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. The intensity selection refers to the patient pad. The radiation intensity reaching the patient's skin is approx. 4 mW/cm² higher than the selected value because the distance of the radiant warmer to the patient's body surface is approx. 10 cm shorter than to the patient pad. When the patient shall stay under the radiant warmer for longer time at an intensity above 10 mW/cm² it is recommendable to survey the body temperature, e.g. with temperature monitor APGAR DIGITEMP order No. WY1004. In that case the safety function >10 mW/cm² can be switched-off temporarily by a conscious action. Push button (4) for approx. 3 seconds until two short tones sound and the warning lamp (10) flashes. When the safety function >10 mW/cm² shall be reactivated, push button (4) again for approx. 3 seconds until one short tone sounds. The warning lamp (10) stops flashing. It lights when in case of intensity selection >10 mW/cm² the safety function >10 mW/cm² is switched-on. When the radiant warmer is switched-on anew, the safety function is always activated. 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. (refer to "Technical Data", page 20, as well as the data under the individual mounts, pages 21 to 24). In case of a selection which the radiant warmer is unable to reach, the maximum intensity is indicated by a permanent LED spot in display (12). The unreachable selection is indicated by a flashing LED spot. In that case reduce the intensity selection to the reachable value by turning the knob (13) anti-clockwise.

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Instruction for use Radiant Warmer CERAMOTHERM 1000

Mounts Static arrangement to the patient pad

Ceiling mount Distance between patient pad and bottom line of solid ceiling max. 2600 mm.

Wall holder Wall holder Lateral mounting

Flexible arrangement to the patient pad

Wall arm 320 mm, 480 mm or 600 mm long Fixed distance to the patient pad. Horizontal swiveling 180° with fixing facility, rotation of warmer 360°.

Upgrade option: Vertical adjustment ± 45° Upgrade option: Vertical extension 250 mm

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Instruction for use Radiant Warmer CERAMOTHERM 1000

Unfasten the fixing facility (F) by anti-clockwise turning. Rotate respectively swivel the warmer to the desired position. Use the two handles and do not touch the safety guard. Take care that the wall arm will not clash with other devices in the ambience, as e.g. ceiling lights, mobile stands, etc. Then fasten the fixing facility again by clockwise turning.

F

When supplementary option vertical adjustment ± 45° is available:

F

When the radiation shall be focussed to the patient in diagonal instead of vertical direction, unfasten the release handle (H) by anticlockwise turning and adjust the warmer to the desired direction. Afterwards fasten the release handle again by clockwise turning.

K

Double-joint wall arm Fixed distance to the patient level. Horizontal swiveling 180° with fixing facility, rotation of warmer 360°, vertical adjustment ± 45°. Unfasten the fixing facility (F) by anti-clockwise turning. Rotate respectively swivel the warmer to the desired position. Use the two handles and do not touch the safety guard. Take care that the wall arm and the extension will not clash with other devices in the ambience, as e.g. ceiling lights, mobile stands, etc. Afterwards fasten the fixing facility again by clockwise turning. When the radiation shall be focussed to the patient in diagonal instead of vertical direction, unfasten the release handle (H) by anticlockwise turning and adjust the warmer to the desired direction. Afterwards fasten the release handle again by clockwise turning.

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F K

Instruction for use Radiant Warmer CERAMOTHERM 1000

Height-adjustable mounts Application to babies and defenseless persons under surveillance only! The safety distance of 650 mm between the bottom line of the radiant warmer and the patient pad must be maintained. If necessary it must be secured in a mechanical way, i.e. by a stop in the height-adjustable spring-balanced arm.

Double-joint arm Adjustable distance to the patient pad. Horizontal swiveling 180° (wall arm) respectively 360° (ceiling arm), adjustable stop for highest position, rotation of warmer 360°, vertical adjustment ± 45°.

H

H

Double-joint wall arm

Double-joint ceiling arm

Rotate respectively swivel the warmer to the desired position. Use the two handles and do not touch the safety guard. Take care that wall or ceiling arm extensions will not clash with other devices in the ambience, as e.g. ceiling lights, mobile stands, etc. When the radiation shall be focussed to the patient in diagonal instead of vertical direction, unfasten the release handle (H) by anti-clockwise turning and adjust the warmer to the desired direction. Afterwards fasten the release handle again by clockwise turning.

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Instruction for use Radiant Warmer CERAMOTHERM 1000

Mobile radiant warmers Application to babies and defenseless persons under surveillance only! H

Height-adjustable mobile stand, 4 anti-static castors, 2 with kickstop, rotation of warmer 360°, vertical adjustment ± 45°.

Unfasten the knob of the height-adjustment (1) by anticlockwise turning and adjust the stand to the lowest position. Fasten the knob again by clockwise turning. Release the kickstop of the castors, move the device to the desired position and brake the castors again. The device must be moved in lowest position only. The radiant warmer is calibrated to a distance of 650 mm (safety distance) to the patient pad. Now adjust the height in a way that the red distance mark (2) is at the level of the patient pad. Take care that the knob of the height-adjustment (1) is fastened again by clockwise turning. Rotate respectively swivel the warmer to the desired position. Use the two handles and do not touch the safety guard. When the radiation shall be focussed to the patient in diagonal instead of vertical direction, unfasten the release handle (H) by anti-clockwise turning and adjust the warmer to the desired direction. Afterwards fasten the release handle again by clockwise turning.

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1

2

Instruction for use Radiant Warmer CERAMOTHERM 1000

Safety and alarm functions 13

4

12

3

2

1

Test / Alarm 30

20

+

?

Intensity

>10 mW cm²

10

DFSBNPUIFSN

mW cm²

11

10

7

6

5

Display / Lamps

Alarm tone

Cause / Effect

Measure

(7) flashing

Short tone every 10 seconds

Battery capacity not sufficient for power failure alarm. Audible alarm not secured for 10 minutes.

Replace battery (9V-E Block) at the bottom side of the radiant warmer.

(7) lighting, remaining displays are off

Permanent, non-resettable

Power failure Power plug disconnected inconsciously or any other interruption in the power supply. No heating, patient becomes hypothermic.

Switch-off the radiant warmer with button (2). Make sure that the patient is cared for in another way. Check the power supply and the fuses.

(10) lighting

No alarm tone

Intensity selection above 10 mW/cm². Safety function >10 mW/cm² is activated.

Watch the patient's temperature.

LED's for 10 mW/cm² and for the intensity selection flash alternately.

Intermittent 1 : 2

Radiation intensity above 10 mW/cm² High intensity for more than 15 minutes. Alarm and automatic intensity reduction. May bring an infant in a hyperthermic condition.

Check the patient's temperature. Reduce the intensity selection if necessary or push button (4). The alarm is reset and the radiant warmer will emit the selected intensity for further 15 minutes.

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Instruction for use Radiant Warmer CERAMOTHERM 1000

Cleaning and disinfection The radiant warmer should be cleaned and disinfected for every new patient, however, at least once per week.

Cleaning agents and disinfectants Never use inflammable disinfectants! Do not use scouring cleaning agents. Use only disinfectants on the basis of aldehydes and quaternary ammonium merges. Unsuitable are tincture of iodine 5 %, carbolic acid, spirit, ether, acetone and other alcoholic agents as well as disinfectants on the basis of halogen-splitting merges, strong organic acids and oxygen-splitting merges. When choosing a substance generally the manufacturer's recommendations must be observed. The manufacturer of the substance is hold liable for the application field and possible material damages. The following disinfectants can be recommended: Incidur® Gevisol Buraton 10F Bacillotox

Henkel Hygiene, Düsseldorf / Germany Schülke & Mayr, Norderstedt / Germany Schülke & Mayr, Norderstedt / Germany Bode, Hamburg / Germany

Cleaning and disinfecting After use switch-off the radiant warmer and wait until it has cooled-off. Disconnect the power plug. Clean the device with a cloth slightly saturated with cleaning agent and wipe it dry. No liquid must enter into the top of the device housing. The ceramic heating elements must not be treated with cleaning agents or disinfectants! After disinfection let the radiant warmer dry for at least 1 hour. Do not switch it on in order to accelerate the drying process. After cleaning and disinfection check the functions.

Waste disposal Fluorescent tubes: Batteries:

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Hazardous waste. Hazardous waste.

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Instruction for use Radiant Warmer CERAMOTHERM 1000

Maintenance Nomenclature Qualified person Authorized qualified person Inspection Preventive maintenance Repair Maintenance

= Skilled worker, engineer, bio-medical engineer, with corresonding qualification. = Qualified person, who has acquainted special knowledge of a certain product. = Ascertainment of the actual state. = Measures to maintain the nominal state. = Measures to restore the nominal state. = Inspection, preventive maintenance, repair.

In order to ascertain the safe operation of the infant radiant warmer CERAMOTHERM 1000, we recommend an inspection by qualified persons once per year which include the following checks: • • • • • • •

Verification that the actual use is in conformance with the normal use. General condition of the device. Secure position of the mounts. Function and secure fixing of the adjusting facility (if available). Possible damages at the device, mounts or power cord. Functions of the device and safety provisions. Measurement of the electrical safety according to the national standards.

The battery securing the power failure alarm should be changed by qualified persons once per year, however, at the latest when the warning lamp (7) flashes during operation. The battery compartment is placed at the bottom side of the radiant warmer, beside the nameplate. In order to maintain the nominal state on occasion of the yearly inspection we also recommend a preventive maintenance by qualified persons which additionally includes the following: • Check of interior wiring, connections and heating elements. • Check of all safety relevant parameters according to IEC 601-2 and EN-60601-2-21. 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. Devices respectively device components have to be cleaned and disinfected prior to each maintenance measure or when they are sent out to our factory for repair.

Spare and wear parts Order No.

Description

EH0227 EH0218 EG0002

11 W fluorescent tube (CERAMOTHERM 1100) Fluorescent tube 18 W (CERAMOTHERM 1200) Battery 9 V energy block

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Instruction for use Radiant Warmer CERAMOTHERM 1000

Technical Data Transport and storage Temperature Relative air humidity Atmospheric pressure

0 to 70°C 15 to 95 % 210 to 1100 hPa

The radiant warmer must not be exposed to strong vibrations.

Ambient requirements Temperature Relative air humidity Atmospheric pressure

18 to 30°C 15 to 95% 860 to 1100 hPa

The radiant warmer is not suitable for the use in explosion-hazardous areas.

General data WY1100 WY1200 without mount Dimensions Depth Width Height Weight

450 mm 220 mm 100 mm 5.8 kg

710 mm 220 mm 100 mm 8.2 kg

Operating / Performance data Operating voltage / power supply Wave length spectrum Standard distance to patient pad: Wall mounts, static and swiveling Ceiling mount, static Wall- or ceiling mounts, height-adjustable Mobile stand, height-adjustable Safety distance to the patient pad Factory calibration of distance possible Increments of intensity selection Intensity selection display Resolution of the intensity selection display Safety function (alarm / automatic intensity reduction) Heating-up period from 24°C ambient temperature to max. intensity selection

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∼ 230 V / 50 Hz 1500 to 6800 nm 900 mm 900 mm 800 mm (operating distance) 650 mm 650 mm 650 to 900 mm 2 mW/cm² LED-spot field 2 to 30 mW/cm² 2 mW/cm² per LED field After 15 minutes above 10 mW/cm² Approx. 15 minutes

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Instruction for use Radiant Warmer CERAMOTHERM 1000

Max. power input Heating element(s), ceramic Intensity selection / irradiated area at distance to patient pad: 650 mm 700 mm 750 mm 800 mm 850 mm 900 mm Illumination

CERAMOTHERM 1100 690 W / 3 A 1 x 600 W

CERAMOTHERM 1200 900 W / 3,9 A 2 x 400 W each

2-28 mW/cm² / 390 x 520 mm 2-24 mW/cm² / 430 x 540 mm 2-20 mW/cm² / 460 x 560 mm 2-18 mW/cm² / 480 x 580 mm 2-16 mW/cm² / 500 x 600 mm 2-14 mW/cm² / 520 x 620 mm 2 fluorescent tubes 11 Watt each

2-30 mW/cm² / 390 x 680 mm 2-30 mW/cm² / 430 x 700 mm 2-26 mW/cm² / 460 x 720 mm 2-22 mW/cm² / 480 x 730 mm 2-20 mW/cm² / 500 x 750 mm 2-18 mW/cm² / 520 x 770 mm 2 fluorescent tubes 18 Watt each

Classification Protection class Device type MDD class

1 B IIa

Standards The device complies with

EN 60601(edition 1996) EN 60601-2-21, 1995-12 resp. modification A1 1998-0

Certification

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