RH 600 Infant Radiant Heater Instructions for Use 3rd edition July 2001

Safety

For Your Safety and That of Your Patients Strictly follow the Instructions for Use

Liability for proper function or damage

Any use of the apparatus requires full understanding and strict observation of these instructions. The apparatus is only to be used for purposes specified here.

The liability for the proper function of the apparatus is irrevocably transferred to the owner or operator to the extent that the apparatus is serviced or repaired by personnel not employed or authorized by DrägerService or if the apparatus is used in a manner not conforming to its intended use.

Maintenance The apparatus must be inspected and serviced yearly by trained service personnel (and a record kept). Repair and general overhaul of the apparatus may only be carried out by trained service personnel.We recommend that a service contract be obtained with DrägerService and that all repairs also be carried out by them. Only authentic Dräger spare parts may be used for maintenance. Observe chapter "Maintenance Intervals".

Dräger cannot be held responsible for damage caused by non-compliance with the recommendations given above. The warranty and liability provisions of the terms of sale and delivery of Dräger are likewise not modified by the recommendations given above. Dräger Medical AG & Co. KGaA

Accessories Do not use accessory parts other than those in the order list.

Not for use in areas of explosion hazard This apparatus is neither approved nor certified for use in areas where combustible or explosive gas mixtures are likely to occur.

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Intended Use

Intended Use The RH 600 infant radiant heater is a radiant heater for keeping premature babies, neonates and infants, up to a body weight of 8 kg, warm. It is intended for use in the delivery room, neonate unit, paediatric unit and paediatric intensive care units. This apparatus must be operated by a doctor or by nurses or care assistants under the instructions of a doctor.

Therapeutic and care possibilities:

Always maintain a minimum distance of 60 cm between the infant radiant heater and the bed. Otherwise, risk of burning the patient.

Do not use skin temperature control for patients in shock or with a high temperature.

Do not use mobile phones within 10 metres of the apparatus. Mobile phones can disrupt the function of electromedical equipment and can thereby endanger the health or life of patients.*

– Reanimation station – Care station for normal and intensive care – Warming and compensating for heat loss – Weaning of incubator infants – Timer for APGAR test

Heating possibilities of the RH 600 infant radiant heater: – Operation of the radiant heater with set heat output: Radiant heater output controlled in manual mode, with treatment time monitored at higher heater outputs. – Radiant heater operated with automatic skin temperature control: Skin temperature controlled and monitored.

*

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Dräger medical appliances comply with the interference immunity requirements of the specific standards for the products or EN 60601-1-2 (IEC 601-1-2). However, depending on the design of the mobile phone and situation of use, field strengths may occur in the immediate environment of a mobile phone that exceed the values of the standards quoted and therefore cause interference.

Intended Use

Installation options: – Mounted on wheeled stand

1-382-94

– Wall-mounted

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Preparation Positioning the apparatus Checking readiness for operation

Preparation Positioning the apparatus Installation on wheeled stand 1 Unscrew the height-setting screw and set the distance between the radiant heater and the patient. Always maintain the minimum clear height between the bottom edge of the infant radiant heater and the patient = 60 cm. ●

Retighten the height-setting screw. Check that the tube cannot slip down.

●

Position the stand so that the radiant heat is directly above the patient.

2 at least 60 cm

1

2 Turn the swivel-adjusting screw and tilt the radiant heater so that the radiant heat is directed evenly at the patient.

Prevention of tipping Do not tilt the apparatus by more than 10°. ●

Do not place any objects on the trolley bracket.

Wall-mounted installation ●

Always keep a minimum clear distance of 60 cm to the patient.

Checking readiness for operation Before using for the first time ●

Check that the mains power supply conforms to the specifications on the rating plate next to the power cord.

●

Plug in the power plug.

XXX XXXX

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Preparation Checking readiness for operation

Before each use 1 Press the power switch until it clicks into position = ON. The microprocessor then runs a self-test to check that the apparatus is functioning correctly. All displays come on for about 1 second. All numeric displays show 88.8. A continuous tone is sounded. The apparatus then switches over to »Man« mode (manual adjustment of heater output).

2

1

2 The message Err on the display indicates a fault. See page 50.

3 5 LEDs are lit in the heater output display = heater level 5. 4 Press key † or ˝ and release immediately. Heater level 5 is accepted. If the keys are held down, the heater level is changed.

6 5 Press key 6: a reference temperature is simulated to check the temperature measurement. 6 The message 36 °C (±0.1 °C) should appear in the temperature display. If not, see page 50.

4 3 4 5

Checking the power failure alarm and NiCd rechargeable battery ●

Disconnect the power plug.

7 The red LED marked N comes on. An intermittent tone is sounded: the volume of this signal must remain constant for at least 30 seconds. If the volume fades earlier: ●

Leave the apparatus switched on and connected to the mains until the battery is charged.

●

Repeat the test.

7

In the event of power failure, or if the apparatus is accidentally switched off, the settings remain stored in memory for 5 minutes.

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Preparation Checking readiness for operation

Checking the lighting 1 Press the light switch M: The resting surface of the bed will be illuminated. 1 Press switch Monce again: The light will be switched off. 2 Press the power switch in as far as it will go = OFF.

1 2

Checking the skin temperature sensor Only for skin temperature control. With the apparatus switched on, 3 Press the µ key: the apparatus switches over to »Man« (manual) mode.

5

4 Plug in the skin temperature sensor. 5 The measured temperature is displayed, or 3 dashes at bottom of display = temperature less than 33 °C 3 dashes at top of display = temperature above 38 °C If 3 dashes are displayed in the middle of the display: ●

See section on "Troubleshooting", page 50.

Checking that the care devices are ready for operation ●

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Check the Babytherm 8000 WB and PhotoTherapy 4000 as indicated in their specific Instructions for Use.

4

3

Operation Safety precautions

Operation Safety precautions Do not place any articles, e.g. material, on top of the infant radiant heater. Ventilation would be impeded, and the infant radiant heater and deposited article could be damaged. Do not touch the top surface of the radiant heater or the mesh guard. Danger of burns.

For the connection of auxiliary devices to the patient, use only devices conforming to EN 60601-1. The measuring functions of the apparatus must be inspected regularly. See the section on "Maintenance Intervals", page 49.

During operation, do not use any inflammable cleaning agents or medicaments. Fire hazard. Additional external heat sources, such as a radiant photo-therapy unit or mattress heater increase the energy supply to the patient and must be taken into account. Environmental conditions, e.g. draughts, can affect the temperature balance of the patient. Avoid direct sunlight and draughts. Draughts reduce the effect of the infant radiant heater at the surface of the bed. Always keep the minimum distance of 60 cm between the infant radiant heater and the bed. Otherwise there is a risk of causing burns to the patient. Wait for the heater to warm up. The apparatus is only ready for use after 25 minutes. Do not place medicines and infusion solutions within the radiation range. Do not use skin temperature control for patients in shock. The skin temperature of a patient in shock is much lower than normal. The patients would be excessively warmed if the skin temperature control system were used. For patients in shock, adjust the heater output in »Man« mode and measure the core temperature every 15 minutes. Do not use skin temperature control for patients with a high temperature. The skin temperature will be much higher than normal. The patients would be overcooled by the skin temperature control.

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Operation Setting the heater output manually

Setting the heater output manually In »Man« mode E.g. for short-term treatment or for infants in shock and for whom automatic skin temperature control must not be used. The radiant heater delivers a preset heat output, regardless of the body temperature of the infant. Do not operate the apparatus without medical supervision. Regularly check the core temperature of the infant. To remind the user to monitor the core temperature constantly at higher heater output levels, an intermittent tone (3 short bleeps) is sounded every 15 minutes at heater level 6 and above. Acknowledge this audible alarm by pressing the ® key (no audible alarm is emitted in the lower range up to heater level 5). 1 Press the power switch until it clicks into place = ON. Wait for completion of the self-test. The apparatus then switches over to »Man« mode. 2 The green LED in the µ key lights up. 3 5 green LEDs flash in the heat level display = heat level 5. This setting can be used as a standby setting to warm the resting surface of the bed.

4 3 4

4 Briefly press key † or ˝ : the green LED segments will remain constantly lit.

2

1

Wait for the warm-up time Wait 25 minutes before using the apparatus. ●

Warm up in »Man« mode and with heat level 5.

Changing the setting 5 Hold down key † or ˝. The heater level can be adjusted in discrete increments, i.e. segment by segment. Each LED segment represents a heater level of approx. 10 % of the maximum heater output. 6 The yellow LED O lights up or flashes according to the heating phases.

6 5

5

Regularly check the core temperature At heater level 6 and above, an intermittent audible alarm is emitted every 15 minutes to remind the operator to check the patient's core temperature. The radiant heater continues to heat. 7 Acknowledge this signal with the ® key. If a skin temperature sensor is connected or applied in manual mode, it will generate a skin temperature display but will not automatically control the skin temperature. 38

7

Operation Using skin temperature control

Using skin temperature control In this operating mode, the skin temperature of the infant is constantly adjusted towards a selected temperature setting. The sensor attached to the skin measures the skin temperature. If the measured skin temperature is lower than the set value, the radiant heater level is increased. If the skin temperature is higher than the set value, the radiant heater level is reduced. Therefore: not use for infants in a state of shock. Their [ Do skin temperature will be much lower than normal. If automatic skin temperature control is used, it would cause overheating of the body (hyperthermia). Set the heater level manually, see page 38. not use for infants with a high temperature [ Do (fever). Their skin temperature will be much higher than normal. If automatic skin temperature control is used, it could induce hypothermia. Check the set value or set the heater level manually, see page 38.

When using the disc-shaped skin temperature sensor: 1 Plug the sensor connector into the socket.

1

When using the rod-shaped skin temperature sensor: 2 Connect the adapter cable to the sensor cable and 3 Plug the adapter connector into the socket.

3

2

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Operation Using skin temperature control

Connecting the skin temperature sensor If using the disc-shaped skin temperature sensor: ●

Fit the double-sided adhesive ring to the temperature sensor:

●

Detach the adhesive ring from its backing and stick it concentrically to the annular surface of the sensor.

●

Detach the protective foil from the adhesive ring and stick the sensor to the appropriate part of the skin with the adhesive ring.

If using the rod-shaped skin temperature sensor: ●

Attach the tip of the sensor to the appropriate part of the skin with adhesive tape, e.g. 3M Microfoam 25 mm/1528-1.

If the infant is in the dorsal position: ●

Attach the sensor to the abdomen in the region of the liver.

If the infant is in the prone position: ●

Attach the sensor to the back, preferably in the region of the kidneys.

Never place the sensor under the baby: otherwise, the core temperature rather than skin temperature would be measured and adjusted.

●

Secure the sensor cable with adhesive tape.

●

Regularly check that the skin temperature sensor is in the correct position. If the skin temperature has fallen from the infant, it will measure air temperature, leading to a risk of excessively warming the infant.

●

Never use the skin temperature sensor to measure rectal temperature.

●

During skin temperature control, the sensor must never be used rectally, since otherwise it would be measuring core temperature instead of skin temperature as feedback control parameter.

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Operation Using skin temperature control

1 Press the power switch until it clicks into position = ON. After the self-test, the apparatus switches to »Man« (manual) operating mode.

1

If the temperature is outside the measuring range from 33 °C to 38 °C: ●

3 dashes at bottom of display = Temperature below 33 °C.

●

3 dashes at top of display = Temperature above 38 °C.

●

See section on "Troubleshooting", page 50.

°C

°C

Allow at least 5 minutes for the skin temperature sensor to adjust to the temperature of the infant.

If the displayed value remains constant: 2 Press the ¡ key: skin temperature control is activated, and the green LED is lit. 3 The skin temperature is displayed in the temperature display.

3

2

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Operation Using skin temperature control

The system initially proposes the default temperature setting 36.3 °C. 1 The value 36.3 °C flashes in the display. 2 Briefly press and release p or P to confirm the value.

3

1 The displayed value remains constant.

2 The temperature setting can be adjusted in 0.1 °C steps:

2 1

2 Hold down key p or P until the desired temperature setting appears in the display. 3 The yellow LED O lights up or flashes according to the adjustment (heater function display).

To check heater function during operation: 4 Press the 6 key. 5 The simulated temperature value must be 36 °C (±0.1 °C) (function check).

5

4

If the sensor probe is disconnected or the sensor is defective: 6 Three flashing dashes in the middle of the display 7 the red alarm LED marked Sensor flashes. A continuous audible alarm tone is emitted. ●

Immediately connect the sensor plug or change the skin temperature sensor.

If the error cannot be remedied immediately: ●

Remove the skin temperature sensor from the patient.

●

Switch to manual mode (»Man«). See "Troubleshooting", page 50.

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6

7

Operation Using skin temperature control Using the timer

Allow time for the system to reach steady state Deviations between the set and measured skin temperature are normally corrected within 5 to 15 minutes. An infant's skin temperature changes frequently, for instance as a result of food intake or handling. Deviations of a few tenths of a degree are normal. Therefore: Only change the set value for skin temperature if the core temperature needs to be corrected. For deviations of more than ±0.5 °C between the set skin temperature and the measured skin temperature:

2 1

1 The red LED marked ±0.5 °C flashes, and an intermittent tone is sounded. The intermittent tone can be muted for approx. 10 minutes: 2 Press the G key. The yellow LED in the key will come on.

Using the timer for up to 100 minutes. If the timer is started e.g. at the time of a birth, three short tones are sounded after 1 minute, after 5 minutes and after 10 minutes to prompt an entry in the APGAR report. To start the timer: 3 Press key ¨.

3

4

To stop: 4 Press key Y. To reset the display: 4 Press key Y a second time.

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Operation Adjusting the halogen lamp beam Shutdown

Adjusting the halogen lamp beam for precisely aimed lighting 1 Press the tabs towards the front panel to adjust the light cone towards the rear. Pull the tabs to move the light cone forwards.

13

Shutdown First: ●

Fully press in the power switch = OFF.

Then: ●

Disconnect the power plug. These two steps must not be performed in reverse order, because otherwise the power failure alarm is activated.

Wait approx. 30 minutes for the apparatus to cool down before servicing/cleaning.

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3 1

Operation Setting instructions

Setting instructions Operating the RH 600 infant radiant heater Constantly monitor the core temperature and adjust the temperature setting to the requirements of the patient. ●

Do not fit a cover panel, otherwise the radiant heater will be ineffective.

●

Do not cover or clothe the infant.

Operation of the RH 600 infant radiant heater and mattress heater with gel mattress (e.g. Babytherm 8000 WB) ●

Set the mattress temperature to the appropriate core temperature for the patient, e.g. between 38.0 °C and 38.3 °C for a premature neonate, or 37.0 °C for a neonate born after the full term. Set the skin temperature setting to the appropriate skin temperature for the patient, e.g. 37.0 °C for a premature neonate, or 36.5 °C for a neonate born full term.

●

Increasing the temperature of the patient: Set the mattress temperature to the desired core temperature. If necessary, increase the skin tempera-ture setting accordingly. For infants with severe hypothermia: adjust the mattress temperature and skin temperature settings so that the patient is warmed by about 1 °C per hour. 45

Operation Setting instructions

●

Stabilising the temperature of the patient: Set the mattress temperature to the present core temperature, and set the skin temperature control setting to the present skin temperature.

●

Reducing the temperature of the patient: Set the mattress temperature to the desired core temperature. If necessary, slightly reduce the skin temperature setting accordingly.

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Phototherapy

Phototherapy To reduce risk of hyperthermie you may use phototherapy in combination with the RH 600 infant radiant heater. Otherwise, risk of inducing hypothermia in the undressed infant. Example: Wall-mounted RH 600 with Babytherm 8000 WB and Photo-Therapy 4000 ●

Push the stand of the phototherapy unit under the frame of the infant bed, e.g. Babytherm 8000 WB.

●

Tilt the lamp housing towards the bed.

●

Adjust the height of the phototherapy unit: minimum clearance between the lower edge of the lamp body and the patient: 0.3 metres.

●

Position the lamp housing so that the radiant heat reaches the patient unimpeded.

●

Follow the specific Instructions for Use of the phototherapy units.

6 5

7 e

Fus

min. 0,3 m

If operating the radiant heater in »Man« mode: ● Reduce the heater output level by 3 steps compared to operation without phototherapy. Using the phototherapy units will result in increasing the temperature of the infant. Monitor the core temperature of the infant.

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Care

Care Shutdown ●

Switch off the device(s). Disconnect the power plug.

For example, the following wipe-disinfectants may be used: Bacillotox Incidur

Bode, Hamburg Henkel Hygiene GmbH, Düsseldorf Dismozon pur Bode Chemie GmbH & Co. Sekusept-Pulver Henkel Hygiene GmbH, Düsseldorf

Cleaning/disinfecting ●

Allow the radiant heater to cool down for about 30 minutes before cleaning/disinfecting.

●

Do not allow any liquids to enter the apparatus.

Wheeled stand; Infant radiant heater, exterior: ●

Remove any visible impurities with a disposable cloth soaked in washing-up liquid.

●

Wipe-disinfect all surfaces.

●

Wait the specified time for the detergent to act and then wipe off with a damp cloth and dry.

Only use the recommended detergents and disinfectants. Unauthorised products, e.g. alcohol, may cause stress cracking of the acrylic glass and "macrolon" material. Use only preparations classified as "surface disinfectants" for disinfecting. For material compatibility, we recommend preparations based on – aldehydes – quaternary ammonium compounds. Due to possible damage to materials, the following preparations are unsuitable: – halogen-releasing compounds – strong organic acids – oxygen-releasing compounds. For users in the Federal Republic of Germany, we recommend the use of disinfectants listed in the current DGHM list (DGHM = German Society for Hygiene and Microbiology). The DGHM list (published by mhp Verlag GmbH, Wiesbaden) also specifies the active basis of each disinfectant. For countries where the DGHM list is unavailable, we recommend products based on the above active compounds.

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Follow the Instructions for Use provided by the detergent manufacturer.

Before next use ●

After wipe-disinfection, operate the fully assembled unit for a few hours without the patient, in order to eliminate any disinfectant residues. Set the radiant heater to heat level 5 in »Man« mode.

●

Check that the unit is ready for operation: see page 34.

Maintenance

Maintenance intervals Always clean and disinfect the unit and accessories before any maintenance – even when returning the unit to supplier for repair.

[ Always disconnect power supply before any maintenance.

Temperature measuring system

The complete measuring chain must be checked as part of the safety check by factory-trained technicians

Ni-Cd battery for power failure alarm

Must be replaced after 2 years by factory-trained technicians

Time Keeper RAM

After 4 years by factorytrained technicians

Metrological inspections

Once a year by factorytrained technicians

Inspection and maintenance Once a year by factorytrained technicians

Disposal of used batteries – Do not throw into fire. – Do not force open. Danger of chemical burns. Batteries may explode. Batteries must be treated as special waste: ●

Discard in conformity with local waste disposal regulations.

Please obtain information from your local environmental and planning authorities and waste disposal companies.

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