THERMOCARE K Instructions for Use V1.00

Instructions for use Neonatal warming bed THERMOCARE K

Normal use ...4 General safety instructions ...4 Transport and storage ...4 Ambient requirements ...5 Installation...5 Structure and operating principle ...6 1. Trolley ...6 2. Bassinet ...7 3. Under-pad heating device ...7 4. Perspex wall assembly with canopy...7 5. High-grade steel tubes ...7

Start-up ...8 Function check of the moving mechanical components ...8 Functions of the under-pad heating device ...9 Switch on the under-pad heating device...10 Switch-on test ...10 Start heating...10 Temperature selection ...10 Remark for heating up...11 Brightness adjustment of the temperature display... 11 Alarm system ...11 End of operation ...13

Use ...14 Warnings for use ...14 General ...14 Adjustment ...14 Under-pad heating device...14 Phototherapy...15 Bassinet with perspex wall assembly ...16 Temperature selection of the under-pad heating device ...17

Upgrade items / accessories ...18 Additional devices...19

Safety and alarm functions ...20 Cleaning and disinfection...24 Cleansing agents and disinfectants ...24 Dismantling, cleaning and disinfection ...25

Waste disposal ...25 Maintenance...26 Spare and wear parts ...27

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Instructions for use Neonatal warming bed THERMOCARE K

Technical data ...27 Transport and storage ...27 Ambient requirements...27 General data ...28 Operating / performance data...28 General ...28 Under-pad heating device...29 Classification ...29 Standards ...29 Certification...29

Declaration of conformity ...30

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Instructions for use Neonatal warming bed THERMOCARE K

Normal use The neonatal warming bed THERMOCARE K is used for warming care of infants up to 12 kg weight and for performing basic therapies such as oxygen therapy and phototherapy or similar. It is suitable for continuous operation and complies with the "Particular requirements for the safety of blankets, pads and mattresses, intended for heating in medical use EN-60601-2-35:2010".

General safety instructions The user must be thoroughly acquainted with this instruction for use. The warming bed must only be used under medical supervision by qualified persons only who are acquainted with the use and risks of under-pad heating devices. This instruction for use must be kept ready to hand for the user. The under-pad heating device must be used with the original Weyer gel pad order No. WY0620 only. Otherwise the safety features of the neonatal warming bed are impaired. When the under-pad heating device is switched off, the gel pad may cause a reduction of the patient's temperature. When nevertheless the neonatal warming bed shall be used with switched off under-pad heating device, for insulation purposes a foam pad or woollen nappy, at least 2 cm thick, must be placed between patient and gel pad. In order to ascertain the safe operation of the neonatal warming bed, we recommend inspections at regular intervals to be performed by qualified persons. In order to maintain the nominal state of the neonatal warmng bed we recommend preventive maintenance at regular intervals to be performed by authorized qualified persons. For normal operating conditions we recommend yearly intervals whereas under unfavourable ambient conditions and in case of high duty use half-yearly intervals should be observed. When connecting additional devices to the warming bed the latest version of the "General requirements for the safety of medical electrical systems EN 60601-1-1 + Supplement A1" must be observed. The max. power input is specified at the take-off sockets and must be considered. The total leakage currents of the connected additional devices must not exceed 250 µA. We can only be held responsible for the safety features of the neonatal warming bed when preventive maintenance and repairs are carried out by authorized 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

15 to 95 % 210 to 1100 hPa

The neonatal warming bed must not be exposed to strong vibrations, such as e.g. transport over cobblestone pavement.

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Instructions for use Neonatal warming bed THERMOCARE K

Ambient requirements The neonatal warming bed can be used under the following operation conditions:

Temperature: Relative air humidity: Atmospheric pressure

15 to 95 % 860 to 1100 hPa

The neonatal warming bed is not suitable for the use in explosion-hazardous areas.

Installation For installation of the neonatal warming bed it has to be considered that heating or air conditioning devices may change the effect of the neonatal warming bed. Therefore a distance of 1 m should be kept clear. The distance of 1 m should also be kept between two warming beds. Places in draughts, at cold walls or windows as well in direct sunlight should be avoided.

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Instructions for use Neonatal warming bed THERMOCARE K

Structure and operating principle The neonatal warming bed THERMOCARE K consists of the following components assemblies:

4.4

1. Trolley 1.1 Height-adjustment 1.2 Electrical distribution / Take-off sockets 1.3 Upgrade items / accessories

4.5 4.2

4.2 4

3.1 4.1

2. Bassinet 2.1 Tilting facility 2.2 Catch

4.1

4.3

5

3. Under-pad heating device

3

2

3.1 Thermo-conductive gel pad

1.2

4. Perspex wall assembly with canopy 4.1 Safety side walls 4.2 Seiten walls 4.3 Front wall 4.4 Rear Wall 4.5 Canopy

2.2

1.3

2.1

1.1 1

5. High-grade steel tubes with instrument and monitor shelf (Upgrade items / accessories)

1.

Trolley

The trolley supports the complete device. It has four antistatic swivel castors, (3 with total lock, 1 with directional lock for easy movability). Four bumpers are provided to protect from damages during a transport. 1.1 Height adjustment The warming bed is height-adjustable by foot pedals, i.e. the complete device is moved electromotively, including the connected additional devices. The foot pedals can be arranged at the front or at the side of the device. As an option a second pair of pedals can be provided. 1.2 Electrical distribution / Take-off sockets 2 take-off sockets ~ 230 V and the power connection for the under-pad heating device are arranged below the rearside of the trolley. 1.3 Upgrade items / Accessories A shelf or a drawer assembly with 2 drawers are available for storing necessary material (refer to page 18).

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2.

Bassinet

The bassinet with tilting facility is arranged on the trolley. Raised sides prevent the infant from trundling out of the bassinet. 2.1 Tilting facility The tilting facility below the bassinet allows a head up / feet down position up to 20° and a feet up / head down position up to 10°. A catch (2.2) is provided to fix the bassinet in the desired tilt position.

3.

Under-pad heating device

An electical heating device is incorporated in the bottom of the bassinet. The temperature is precisely controlled to the selected value. The heat is accumulated in a gel pad (3.1) which conducts it to the patient (conductive heat transfer). The actual under-pad temperature and the selected temperature are permanently displayed. Deviations from the temperature selection, system faults as well as interruption of the power supply are alerted visually and audibly. The temperature display does not give a reliable indication as to the patient's body temperature. Therefore the patient's temperature must be checked in regular intervals or monitored. When the under-pad heating device is switched off, the gel pad (3.1) may cause a cooling of the patient. When nevertheless the warming bed shall be used with switched off under-pad heating device, for insulation purposes a foam pad or woollen nappy, at least 2 cm thick, should be placed between patient and gel pad.

4.

Perspex wall assembly with canopy

The four perspex walls protect the patient from draught and falling from the bassinet. The warming bed can be closed with the canopy (4.5), in that case oxygen can be supplied through the oxygen connector in the rear wall (4.4) into the interior. The open corners of the wall assembly allow a sufficient supply of air and prevent an accumulation of CO2 in the interior. For better accessibility during treatment the two side walls (4.2) can be folded down with one hand. When the canopy (4.5) is not attached, also the front wall (4.3) can be folded down. Two safety side walls (4.1) are additionally provided to protect the patient when the side walls are folded down. When the safety side walls (4.1) are not in use they can be retracted into the bassinet. Cables and tubes connected to the patient are passed through the grommets and the gate in the rear wall (4.4).

5.

High-grade steel tubes with instrument and monitor shelf (Upgrade items / accessories)

Two high-grade steel tubes are provided at the rear of the warming bed for fixing upgrade items and accessories. Additional devices can be placed on the instrument and monitor shelf. When connecting additional devices to the warming bed the latest version of the "General requirements for the safety of medical electrical systems EN 60601-1-1 + Supplement A1" must be observed. The max. power input is specified at the take-off sockets and must be considered. The total leakage currents of the connected additional devices must not exceed 250 µA.

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Instructions for use Neonatal warming bed THERMOCARE K

Start-up Qualified persons only should install and start-up the warming bed and instruct the user's personnel. Before start-up all components of the warming bed must be checked for correct and secure position as well as for correct function. The under-pad heating device must be equipped with a 9V battery which is included in the delivery of the device. The battery compartment B is placed below the bassinet. Prior to operation the warming bed must be prepared in cold condition according to chapter "Cleaning and disinfection" (page 24).

Function check of the moving mechanical components 4.5

4.2 4.2 4.3

2.2 B

1.1

Move the bassinet with the foot pedals (1.1) to the lowest and then to the highest position. Make sure that no items or devices are placed within in the moving range. Unlock the catch (2.2) below the frontside of the bassinet by pulling and tilt the bassinet to feet up / head down and then in reverse position. Check in several positions whether the catch (2.2) locks automatically when being released and whether the bassinet is fixed in this position. For checking the functions of the perspex walls take off the canopy (4.5). Unlock the side walls (4.2) and the front wall (4.3) by lifting and fold them down. They must latch securely again simply by folding up. Before switching on the under-pad heating device make yourself acquainted with the following control elements and displays.

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Instructions for use Neonatal warming bed THERMOCARE K

Functions of the under-pad heating device

3.1

Key audio alarm pause. By pressing the key in case of high or low temperature alarm, the audio alarm is paused for 15 minutes. The length of the alarm pause depends on the alarm priority.

3.2

a) Unlocking key for the extended temperature range (30°C to 35°C and 37°C to 38.5°C). b) Activation of brightness adjustment of the displays 3.6 and 3.7 with knob 3.5.

3.3

Enter key for confirming the desired under-pad temperature (selection).

3.4

Key heating On / Off.

3.5

a) Rotary knob for selection of the under-pad temperature. b) Brightness adjustment of displays 3.6 and 3.7

3.6

a) Temperature selection display. b) Error display.

3.7

a) Actual temperature display. b) Error display.

3.8

Pilot lamp (green) heating power. Lights when heating power is available. When the lamp lights, the bassinet will heat-up, when it does not light, the bassinet will cool-off.

3.9

Warning lamp (yellow). Lights in case of temperature selection below 35°C.

3.10

Warning lamp (yellow). Lights in case of temperature selection above 37°C.

3.11

Warning lamp (red). When it lights together with a permanent audio alarm the power supply of the under-pad heating device is interrupted. The alarm can be reset by switching off the heating (3.4). After reinstallation of the power supply the heating must be switched on again.

3.12

Warning lamp (yellow). Flashes in case of deviation between selected and actual temperature above 1°C.

3.13

Warning lamp (red). Flashes in case of bassinet temperature above 40°C.

3.14

Flashing point. Indicates that the internal processor is working.

3.15

Central switch-off button for under-pad heating.

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Instructions for use Neonatal warming bed THERMOCARE K

Switch on the under-pad heating device Switch-on test: First of all make sure that the warming bed is connected to the power supply. Press key (3.4) until the under-pad heating device is switched on. A tone sounds and all displays light-up for 2 seconds. Both displays (3.6) and (3.7) indicate the value 88.8. Check during the 2 seconds whether all displays light up and the tone sounds. Simultaneously the internal processor automatically checks the vital functions of the electronical control. When the under-pad heating device is not switched on, press key (3.15) (righthand below the bassinet).

When the internal automatic switch-on test was not successful, the reason will be displayed as an error code.

Start heating: When the under-pad heating device is switched on after being switched off for more than 10 minutes, the value 37.0°C flashes in the temperature selection display (3.6) while the actual temperature display (3.7) indicates SET. Furthermore an indicative alarm tone sounds at intervals of 5 seconds.

Now the temperature value suggested in display (3.6) can either be entered by pressing key (3.3) or adjusted with the rotary knob (3.5). The adjusted value must be entered by pressing key (3.3). Then the under-pad heating device will heat according to the selection. When the under-pad heating device is switched on after being switched off for less than 10 minutes, it will start heating with the last temperature selection.

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Temperature selection: The temperature selection is devided in two ranges, i.e. the "standard" range (35°C to 37°C) and the "extended" range (30°C to 35°C and 37°C to 38.5°C). In the standard range the temperature can be adjusted with the rotary knob (3.5) in increments of 0.1°C. Each increment is confirmed by a short tone. The temperature is increased by turning the knob (3.5) clockwise and reduced by turning it anti-clockwise. During adjustment the currently selected temperature flashes. This temperature is entered by pressing key (3.3) and will then be permanently indicated in display (3.6). When key (3.3) is not pressed within 10 seconds after adjustment the under-pad heating device will continue to operate with last setting. When a temperature value in the extended range (30°C to 35°C and 37°C to 38.5°C) shall be selected, turn knob (3.5) briefly, the display (3.6) flashes. Now the desired temperature can be adjusted while keeping key (3.2) pressed. This temperature is entered by pressing key (3.3) and will then be permanently indicated in display (3.6). When key (3.3) is not pressed within 10 seconds after adjustment the under-pad heating device will continue to operate with last setting. When the selected temperature is lower than 35°C the yellow warning lamp (3.9) lights. When the selected temperature is higher than 37°C the yellow warning lamp (3.10) lights.

Remark for heating up: Heating up the bassinet from ambient temperature to 37°C will take approx. 15 minutes. It may take up to 10 minutes more until the gel pad itself has reached the selected temperature.

Brightness adjustment of the temperature display: When key (3.2) is pressed during operation, the brightness of displays (3.6) and (3.7) can be adjusted with rotary knob (3.5).

Alarm system: The under-pad heating device provides an alarm system with 4 priority levels: High - Medium - Low - Indicative The alarms are indicated visually and audibly (audio alarm). The quicker the sequence of alarm tones and the shorter the pauses, the higher is the alarm priority. Audio alarms can be paused with key (3.1) for a certain period. The pause period is according to the alarm priority. Audio alarms are paused automatically for a certain period when they were caused by a logical action of the user, e.g. in case of temperature adjustment.

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Instructions for use Neonatal warming bed THERMOCARE K The most common alarms which are released during operation are mentioned in the following list. A complete list of alarms can be found on pages 20 to 23.

Hazard/ Error condition

Alarm priority

Battery capacity not sufficient for power failure alarm

Indicative

Temperature more than 1°C below selection

Medium

Mute

Intermittent

-,-

Warning lamp

Temperature display Selection

Actual

None

e.g.

e.g.

every

every

15 Sec.

15 Sec.

e.g.

e.g.

Yes

● ±1°C

1.)

Yellow

Action needed

Consequence when neglected

Replace battery.

Power failure alarm not sufficiently secured.

Pause audio alarm.

Patient cools down and becomes hypothermic.

2.) Watch the patient's temperature. If necessary relocate the patient or place an isolating blanket between patient and pad.

Temperature more than 1°C above selection.

Medium

Intermittent

● ± 1°C

1.)

Yellow

e.g.

e.g.

Watch the patient's temperature.

3.)

Medium

Permanent

Pause audio alarm. 2.)

2.)

(Possibly sunlight, external warming devices?)

Interruption of power supply

Yes

If necessary relocate the patient or place an isolating blanket between patient and pad. Dark

No

Dark

Red

Switch off under-pad heating, re-install power supply.

Patient becomes hyperthermic for a short while. After automatic safety switch-off he can become hypothermic again.

Patient cools down and becomes hypothermic.

If necessary relocate the patient or place an isolating blanket between patient and pad. Selection > 37°C Selection < 37°C

Indicative

Mute

Indicative

Mute

-,-

● >37°C

> 37°C

e.g.

Increased attention, check patient's temperature

Patient's core temperature increases.

< 37°C

e.g.

Increased attention, check patient's temperature

Patient's core temperature can fall.

Yellow -,-

● <37°C Yellow

1.)

Automatic alarm pause caused by a logical action of the user (e.g. temperature adjustment).

2.)

When alarms are paused repeatedly there is a permanent fault which must be removed. In such cases the heating is cut off automatically and the audio alarm can no longer be paused. Switch off the under-pad heating with key (3.4) and switch it on again when the fault has been removed.

3.)

At an ambient temperature above 30°C and a temperature selection of 30°C a high temperature alarm may be released. In that case increase the temperature selection to 32°C or switch off the under-pad heating device. When the under-pad heating device is switched off, place a foam pad at least 2 cm thick or a woollen blanket between patient and gel pad in order to avoid that heat is withdrawn from the patient by the cooling gel pad.

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Hazard/ Error condition

Alarm priority

Bassinet is warmer than 40°C.

High

Intermittent

Yes

Bassinet is warmer than 40,5°C.

High

Permanent

No

Warning lamp

Temperature display Selection

Actual

● >40°C

e.g.

e.g.

also ● ± 1°C Yellow

Action needed

Consequence when neglected

Check whether high temperature was caused by sunlight or external warming devices.

Patient can become dangerously hyperthermic.

Switch off under-pad heating device temporarily.

Attention:

Watch temperature (residual heat).

Above 42°C danger of burns.

When the bassinet will not cool down, disconnect the under-pad heating device from the power supply with the central switch-off button (3.15) . Place an isolating blanket between patient and pad. Depending on the situation relocate the patient. Remove the alarm cause. Error in the control system

High

Permanent

No

Depending on situation

Code

up to

Switch off the underpad heating device immediately with central button (3.15) and have it repaired. Relocate patient.

Relay deenergized. Patient may cool down and become hypothermic.

End of operation Switch off the under-pad heating device with key (3.4). All displays extinguish, with the exception of the actual temperature display (3.7). When the under-pad heating device is connected to the power supply, the under-pad temperature is displayed until it has fallen below 30°C. Remark: When the under-pad heating device is switched on again within 10 minutes after switch-off, it will start immediately with the last temperature selection. When the under-pad heating device must be disconnected from the power supply for reasons of device failure or external influences, push central switch-off button (3.15), righthand below the bassinet.

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Instructions for use Neonatal warming bed THERMOCARE K

Use Warnings for use General •

The neonatal warming bed is not suitable for the use in explosion-hazardous areas.

•

The ambient conditions of the warming bed must in no case be influenced by any warming or air condition devices which do not comply with the system.

•

Heating up the bassinet from ambient temperature to 37°C will take approx. 15 minutes. It may take up to 10 minutes more until the gel pad itself has reached the selected temperature. If necessary the heating up process can be accelerated by turning the gel pad upside down during heating up.

•

The display of the neonatal warming bed does not give a reliable indication as to the patient's body temperature.

•

The patient's temperature must be checked in regular intervals or monitored, e.g. with the temperature monitor APGAR-DIGITEMP order No. WY1004.

•

Sunlight, draught, cold walls and windows in direct ambience to the warming bed will influence the patient's temperature balance negatively. Furthermore alarms can be caused hereby.

•

When connecting additional devices to the warming bed the latest version of the "General requirements for the safety of medical electrical systems EN 60601-1-1 + Supplement A1" must be observed. The max. power input is specified at the take-off sockets and must be considered. The total leakage currents of the connected additional devices must not exceed 250 µA.

•

Take care that the patient is never unattended when one or more persepex walls (4.2/4.3) of the bassinet are folded down.

Adjustment •

During height-adjustment make sure that no device components or additional devices connected to the warming bed can touch furniture items or other devices in the ambience.

•

It should also be considered that accessories, which are not fixed at the neonatal warming bed, will not be moved and therefore connected lines and tubes might be pulled off.

•

When moving the neonatal warming bed around bring the height adjustment into the lowest position.

Under-pad heating device •

The under-pad heating device must be used with the original Weyer gel pad order No. WY0620 only. Using other kinds of pads will influence the temperature characteristics negatively.

•

The gel pad cannot destaticize, is not autoclavable and not washing-machine proof.

•

The gel pad can only be bent slightly and therefore must not be folded or laid over sharp edges. Sharp instruments like needles, knives or scissors will damage or even destroy the pad.

•

When the under-pad heating device is switched off, the gel pad may cause a reduction of the patient's temperature. When nevertheless the bassinet shall be used with switched off under-pad heating device, for insulation purposes a foam pad or woollen nappy, at least 2 cm thick, must be placed between patient and gel pad.

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Phototherapy •

When the warming bed is used in connection with a phototherapy device, it must be observed that patient's temperature and humidity loss can increase.

•

Observe the patient's body core temperature. Reduce the temperature selection of the under-pad heating device if necessary.

•

Increase the hydration for the patient according to the increased water absorption by the phototherapy.

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Instructions for use Neonatal warming bed THERMOCARE K

Bassinet with perspex wall assembly Move the bassinet to desired level with the foot pedals (1.1). Take-off the canopy (4.5). Cover the gel pad (3.1) with a thin nappy. Take care that the nappy does not block the wall locking system. The front and side walls (4.2/4.3) must always close smoothly and latch securely. The safety walls (4.1) should be inserted in a way that the patient cannot fall from the bassinet. For better accessibility they can be taken out of their support and inserted again set off by 180°. Thus the walls are retracted into the bassinet, allowing full access to the patient. Cables and tubes connected to the patient should be passed exclusively through the grommets and the gate in the rear wall (4.4). When the under pad heating device is at operation temperature, place the patient on the pad. Take care that the walls are folded up so that the patient cannot fall from the bassinet. Make sure that no body parts, cables of additional devices and tubes are squeezed. Attach the canopy (4.5), if necessary. After unlocking the catch (2.2) tilt the bassinet to the desired position. After releasing the catch check whether it has locked and the bassinet is fixed.

4.4 4.4

3.1

4.5

4.1

2.2

1.1

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Instructions for use Neonatal warming bed THERMOCARE K

Temperature selection of the under-pad heating device

Heat is conducted to the patient The temperature selection of the under-pad heating depends on several factors, e.g.: •

Age and maturity of the patient.

•

Weight.

•

Does the patient suffer from Hypothermia / Hyperthermia?

•

Are vital functions impaired?

•

Which accompanying therapies are applied?

•

Is the patient clothed or unclothed?

For a mature unclothed infant a bassinet temperature of approx. 36.5°C should be selected.

Heat is withdrawn from the patient

For a pre-term neonate a temperature of approx. 37° to 37.5°C is recommendable. For clothed infants the bassinet temperature can be selected 0.5 to 1°C lower. For temperature selection it must be considered that the temperature of the gel pad has a direct influence on the patient (thermal conduction). When the pad temperature is higher than the patient's temperature, heat is supplied to the patient.

Temperature balance

When on the other hand the pad temperature is lower than the patient's temperature, heat may be withdrawn from the patient!

The patient's temperature must be checked in regular intervals or monitored. When the under-pad heating device is switched off, the gel pad may cause a reduction of the patient's temperature. When nevertheless the warming bed shall be used with switched off under-pad heating device, for insulation purposes a foam pad or woollen nappy, at least 2 cm thick, must be placed between patient and pad! In case of ambient temperature above 30°C and a temperature selection of 30°C a high temperature alarm may be released. In that case increase the temperature selection to 32°C or switch off the under-pad heating device.

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Instructions for use Neonatal warming bed THERMOCARE K

Upgrade items / accessories Order No. WY2060 WY2061 WY2067 WY2068 WY1004

WY1620

WY1604

WY1621

B4980 B4986 B4983 B4989 WY1816

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Description Shelf for the trolley, with raised sides and instrument rail 25 x 10 mm at the front-end, load max. 20 kg or optionally: Drawer assembly for the trolley with 2 drawers, top side designed as shelf, with raised sides and instrument rail 25 x 10 mm at the front-end, load max. 20 kg High-grade steel infusion pole Ø 25 mm, 600 mm long, fixed at the instrument and monitor shelf High-grade steel infusion pole Ø 25 mm, height-adjustable, fixed at the instrument and monitor shelf APGAR DIGITEMP Temperature monitor with integrated Apgar timer, fixed at the high-grade steel tube Ø 40 mm. Timer for performing the Apgar test and monitor for measuring the patient's temperature. Normal clock mode. Timer mode with signal after 1 - 2 - 5 and 10 minutes. Skin temperature mode with high and low temperature alarm. Alarm can be reset for 15 minutes and switched off temporarily if necessary. Incl. reusable skin sensor. Suction / oxygen supply Suction unit for compressed air operation, for connection to central pipeline. Vacuum can be adjusted from 0 to 0.6 bar and switched off, suction capacity 27 l/min., incl. suction bottle 250 ml, suction lid with float assembly, suction tube with fingertip valve, pressure tube and clamp for instrument rail 25 x 10 mm Precision oxygen flowmeter for connection to central pipeline, pressure compensated, flow adjustable 0 to 15 l/min., incl. pressure tube and clamp for instrument rail 25 x 10 mm Precision oxygen flowmeter, with bubble humidifier, for connection to central pipeline, pressure compensated, flow adjustable 0 to 15 l/min., incl. pressure tube and clamp for instrument rail 25 x 10 mm Pressure hoses Oxygen connection hose 3 m, white, ISO 32, pipeline plug DIN 13260, NIST union Air connection hose 3 m, black-white stripe, ISO 32, pipeline plug DIN 13260, NIST union Oxygen connection hose 3 m, neutral-black, pipeline plug DIN 13260, NIST union Air connection hose 3 m, neutral-black, pipeline plug DIN 13260, NIST union Phototherapy BILICOMPACT® Phototherapy device for treatment of the neonatal hyperbilirubinemia, to be placed on warming bed THERMOCARE K, 10 energy saving lamps blue BAM/PL9/52, wave length spectrum 460 nm, integrated hour counter, handles.

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Additional devices When external devices are connected to the warming bed it must be checked whether the maximum load of the monitor shelf of 20 kg is sufficient. The "General requirements for the safety of medical electrical systems EN 60601-1-1 + Supplement A1" must be observed. The max. power input is specified at the take-off sockets and must be considered. The total leakage currents of the connected additional devices must not exceed 250 µA. It should also be considered that accessories, which are not fixed at the neonatal warming bed, will not be moved and therefore connected lines and tubes might be pulled off.

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Safety and alarm functions Under-pad heating device

Hazard/ Error condition

Alarm priority

Automatic switch-on test failed

Medium

Yes

Temperature more than 1°C below selection

Medium

Intermittent

Warning lamp

Temperature display

No

None

Error-Code according to the detected failure.

Yes

● ±1°C

1.)

Yellow

Selection

e. g.

Action needed

Consequence when neglected

Do not put the under-pad heating into operation.

None, as it is not possible to switch on the under-pad heating

Pause audio alarm.

Patient cools down and becomes hypothermic.

Actual

e. g.

2.) Watch the patient's temperature. If necessary relocate the patient or place an isolating blanket between patient and pad.

Temperature more than 1°C above selection.

Medium

Yes

● ± 1°C

1.)

Yellow

e. g.

e. g.

Watch the patient's temperature.

3.)

Medium

Automatic alarm pause max. 10 minutes

Pause audio alarm. 2.)

2.)

(Possibly sunlight, external warming devices?)

Temperature adjustment more than 1 °C above actual temperature

Intermittent

If necessary relocate the patient or place an isolating blanket between patient and pad. ● ±1°C

e.g.

e.g.

yellow

Wait until bassinet temperature reaches the selection ± 1°C.

Patient becomes hyperthermic for a short while. After automatic safety switch-off he can become hypothermic again.

None

Watch the patient's temperature.

≡ HT-alarm Temperature adjustment more than 1 °C below actual temperature

e.g.

z .B.

≡ LT-alarm 4.)

Automatic alarm pause caused by a logical action of the user (e. g. temperature adjustment).

5.)

When alarms are paused repeatedly there is a permanent fault which must be removed. In such cases the heating is cut off automatically and the audio alarm can no longer be paused. Switch off the under-pad heating with key (3.4) and switch it on again when the fault has been removed.

6.)

At an ambient temperature above 30°C and a temperature selection of 30°C a high temperature alarm may be released. In that case increase the temperature selection to 32°C or switch off the under-pad heating device. When the under-pad heating device is switched off, place a foam pad at least 2 cm thick or a woollen blanket between patient and gel pad in order to avoid that heat is withdrawn from the patient by the cooling gel pad.

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