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Instructions for Use Neonatal Intensive Care System VARIOTHERM REA-KCE 
 

 

D 2002_01.doc

     

14/39

      

 

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 

3 seconds 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 

Summary of Contents for Variotherm REA-KCE

Page 1: ...207 9698 0 49 2207 4750 e mail info weyermed com Variotherm REA KCE 2043 _________ Under pad heating 2010 _________ Radiant warmer 2200 _________ Year of manufacture ______________ 0 1 2 34 5 5 6 87 9...

Page 2: ...s 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...

Page 3: ...s 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...

Page 4: ...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 o...

Page 5: ...evice 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 bel...

Page 6: ...ce 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 p...

Page 7: ...mination 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...

Page 8: ...dition 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 wi...

Page 9: ...adiant warmer have a 9V battery which is included in the scope of the device The battery compartment B for the under pad heating is placed below the bassinet and the one for the radiant warmer at the...

Page 10: ...tive 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...

Page 11: ...le 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...

Page 12: ...ow 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 ton...

Page 13: ...d ChE The actual temperature display should indicate a value of 37 0 C 0 1 C If the devia tion is larger than 0 1 C the control system is not adjusted correctly If there are deviations in one of the m...

Page 14: ...upted 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 cm double function A...

Page 15: ...ashes 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 c...

Page 16: ...cal 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 confir...

Page 17: ...nes 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 cm is selected...

Page 18: ...all 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 patie...

Page 19: ...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 Hypo...

Page 20: ...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 swive...

Page 21: ...onditions The smaller and immature the patient the higher is his heat demand The lower the ambient temperature the higher is the patient s heat demand If empirical values are not available for an uncl...

Page 22: ...the radiant warmer to the patient surface is approx 10 cm lower than to the surface of the bassinet If during long term care the patient s demand ofheat has stabilized and if this is above a value of...

Page 23: ...adjustment facility When operating the height adjustment make sure that no items or devices are placed within in the moving range It should also be considered that accessories which are not fixed at t...

Page 24: ...any medical drugs or infusion fluid above the radiant warmer or within the area of radiation The safety guard of the radiant warmer can reach a temperature of 85 C Therefore during operation it should...

Page 25: ...ERM it must be checked whether the maximum load of the instrument rail or the monitor shelf of 20 kg is sufficient When connecting electrical devices to the take off sockets of the resuscitation and i...

Page 26: ...adjusted by more than 1 C Watch the temperature 3 12 flashing 3 7 flashing Intermittent alarm tone Temperature deviation 1 C Temperature deviation of more than 1 C for minimum 20 minutes Patient temp...

Page 27: ...ay Alarm tone Error status Permanent tone Sensor short circuit Sensor breakage Measuring value error E r r 0 0 3 Permanent tone An error in the measuring sensor system was stated during the system che...

Page 28: ...rmic Switch off the radiant warmer with button 6 4 and make sure that the patient is cared for in another way Check the fuses of the device 6 10 lighting No alarm tone Intensity selection above 10 mW...

Page 29: ...lected intensity Device cools off to the new selected value Patient temperature is influenced None After cooling off device proceeds operating in normal mode Intermittent alarm tone 1 2 Low intensity...

Page 30: ...hypothermic Switch off the radiant warmer with button 6 2 and make sure that the patient is cared for in another way Have the device checked Non resettable permanent alarm tone Safety cut off Device i...

Page 31: ...s hypothermic Switch off the radiant warmer with button 6 2 and make sure that the patient is cared for in another way Have the device checked and repaired if necessary Non resettable permanent alarm...

Page 32: ...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 spir...

Page 33: ...maintenance includes the following checks in addition to the ones mentioned above Check of Interior wiring connections heating elements Check of all parameters according to IEC 601 2 EN 60601 2 35 un...

Page 34: ...y 3 6 alternately indicates 37 0 and ChE while the actual temperature display must indicate a value of 37 0 C 0 1 C If the deviation is larger than 0 1 C the control system is not calibrated correctly...

Page 35: ...th button 6 2 The device will then immediately change to normal operation mode In order to start the functional test push the alarm reset button 6 4 for approx 3 seconds until an alarm tone sounds The...

Page 36: ...oling period of 10 minutes This function is indicated visually by alternate flashing of values 10 mW cm in the selected intensity LED 6 12a and 12 mW cm in the actual intensity bar graph 6 12b After a...

Page 37: ...Depth 1140 mm Width 585 mm Height 1830 to 2130 mm Bassinet Height 850 to 1150 mm Weight 90 kg Trolley Height adjustment facility operated by foot pedals at choice at the front or at the side Range of...

Page 38: ...automatically Safety cut off at 40 C Radiant warmer Distance to patient level 800 mm Mechanical arrangement swiveling to either side Focus of radiation to the center of the bassinet in any position He...

Page 39: ...class 1 Device type B Classification according to MDD IIb Standards The device conforms to EN 60601 edition 1996 EN 60601 2 35 1997 12 EN 60601 2 21 1995 12 respectively amendment A1 1998 01 Registrat...

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