THERMOCARE K Instructions for Use V1.07

Instructions for use Neonatal warming bed THERMOCARE K

Intended use ... 4 General safety instructions ... 4 Transport and storage ... 4 Requirements of the location ... 5 Installation ... 5 Structure and operating principle ... 6 1. Trolley ... 7 2. Bed ... 7 3. Under-pad heating device ... 7 4. Wall assembly *... 8 5. Upgrade items and accessories * ... 8

Use ... 9 Warnings for use... 9 General ... 9 Adjustment *... 10 Under-pad heating device ... 10 Phototherapy *... 10 Start-up ... 11 Function check of the moving mechanical components ... 11 Functions of the under-pad heating device ... 12 Switch on the under-pad heating device ... 13 Switch on test ... 13 Start heating... 13 Temperature selection ... 14 Remark for heating up ... 14 Brightness adjustment of the temperature display ... 14 Alarm system ... 14 End of operation ... 16 Bed with wall assembly ... 17 Temperature selection of the under-pad heating device ... 18

Device models and mandatory accessories ... 19 Optional upgrade items and accessories ... 19 Additional devices ... 20

Safety and alarm functions... 21 Cleaning and disinfection ... 25 Cleansing agents and disinfectants... 25 Dismantling, cleaning and disinfection ... 26

Waste disposal ... 26 Maintenance ... 27 Spare and wear parts... 28

* Depending on model and configuration

D2131_01

2/34

Instructions for use Neonatal warming bed THERMOCARE K

Technical data ... 29 Transport and storage... 29 Requirements of the location ... 29 General data ... 30 Operating / performance data ... 31 General ... 31 Under-pad heating device ... 31 Classification ... 31 Standards ... 31 Certification... 31 Guidelines and manufacturer's declaration electromagnetic emissions and immunity ... 32

* Depending on model and configuration

D2131_01

3/34

Instructions for use Neonatal warming bed THERMOCARE K

Intended use The neonatal warming bed THERMOCARE K is used for warming care of infants up to 8 kg body weight and max. 70 cm body height for performing basic therapies such as oxygen therapy and phototherapy or similar. It is suitable for continuous operation.

General safety instructions The user of the neonatal warming bed must be thoroughly acquainted with this instruction for use. The warming bed must be used under medical supervision by qualified persons only who are acquainted with the use and risks of under-pad heating devices. The instructions for use must be kept available at all times for users to consult. The under-pad heating device must be used with the original Weyer gel pad 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, the PU pad WY0628 must be used instead of the gel pad or for isolation purposes a foam pad or woollen nappy, at least 2 cm thick, must be placed between patient and gel pad. 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" in their latest version must be observed, in particular the permissible limit values for the total sum of leakage currents. The max. power input is specified at the take-off sockets and must be considered. 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. This device must not be modified without our explicit consent.

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.

* Depending on model and configuration

D2131_01

4/34

Instructions for use Neonatal warming bed THERMOCARE K

Requirements of the location 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. Do not use the warming bed close to high-frequent radiation sources such as HF surgery devices, mobile phones or similar. To avoid the risk of an electrical stroke this device must only be connected to an electrical mains with earth conductor.

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. Locations in draughts, at cold walls or windows as well as in direct sunlight should be avoided. Take care that no items are placed within the height-adjustment* zone. In order to completely separate the warming bed from the electrical mains, the connector plug must be disconnected. During installation respectively mounting take care that the connector plug is accessible at any time.

* Depending on model and configuration

D2131_01

5/34

Instructions for use Neonatal warming bed THERMOCARE K

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

1. Trolley 1.1. Height adjustment * 1.2. Electrical distribution

2. Bed 2.1. Tilting facility 2.2. Catch

3. Under-pad heating device 3.1. Conductive gel pad

4. Wall assembly 250 mm high

or 170 mm high * 4.1. Safety side walls 4.2. Side walls 4.3. Front wall 4.4. Rear wall 4.5. Canopy *

5. Upgrade items and accessories * 5.1. Shelf WY3035 (without drawer max. 4 pieces possible, with drawer max. 2 pieces possible). 5.2. Drawer WY3036, fixed at the shelf WY3035, volume 400 x 150 x 160 mm, load 3 kg, arc-shaped sliding out to both sides (max. 2 pcs. possible). 5.3. Support WY3051 for adapting 2 tubes Ø 27 mm. 5.4. Tube assembly Ø 27 mm WY3055, length 650 mm , for adapting accessories. 5.5. Shelf WY3060 or WY3061

* Depending on model and configuration

D2131_01

6/34

Instructions for use Neonatal warming bed THERMOCARE K

1.

Trolley

The trolley supports the entire device. It has four smooth antistatic double castors, 3 with total lock, 1 with steering lock for easy movability. Four bumpers are provided to protect from damages during a transport. 1.1 Height adjustment * The warming bed is gently and smoothly height-adjustable* by foot pedals ("soft-lift"). In this process the whole body of the device, including the accessories attached to the device, is raised vertically by an electric motor. The foot pedals can be arranged at the front or at either side of the trolley. A second pair of pedals can be provided as an option. 1.2 Electrical distribution The power connection, the power source for the under-pad heating device and the height adjustment* as well as the 3 take-off sockets ~230 V are arranged below the rear side of the trolley.

2.

Bed

The bed with tilting facility is arranged on the trolley. Raised sides prevent the patient from trundling out of the bed. The bed is actively heated (refer to 3. below) and provides a gel pad. 2.1 Tilting facility The tilting facility below the bed allows a fine adjustment of the head up/feet down and feet up/head down position up to 12 °. A catch (2.2) is provided to fix the bed in the desired tilt position. 3.1

3.

Under-pad heating device

An electrical heating device is integrated in the bottom of the bed. The temperature is precisely controlled to the selected value. A gel pad (3.1) accumulates the heat and conducts it to the patient (conductive heat transfer). The under-pad heating device must be used with the original Weyer gel pad WY0620 only. Otherwise the safety of the neonatal warming bed is impaired.

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 at regular intervals or monitored. When the under-pad heating device is switched off, the gel pad (3.1) 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, the PU pad WY0628 must be used instead of the gel pad or for isolation purposes a foam pad or woollen nappy, at least 2 cm thick, must be placed between patient and gel pad.

* Depending on model and configuration

D2131_01

7/34

Instructions for use Neonatal warming bed THERMOCARE K

4.

Wall assembly *

The warming bed is equipped with a wall assembly 250 mm high (WY3021) or 170 mm high (WY3022). A canopy is available as an option (one-piece WY3024 or two-piece WY3025). The four walls protect the patient from draught and falling from the bed. The warming bed can be closed with the canopy* (4.5). The open corners of the wall assembly allow a sufficient supply of air and prevent from an accumulation of CO2 in the interior. Cables and tubes connected to the patient are passed through the grommets in the rear wall (4.4). 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 are not in use they can be retracted into the bed.

4.5 4.1 4.4

4.1 4.4

4.2 4.2

Walls 250 mm high, canopy one-piece or two-piece

5.

Upgrade items and accessories

For storing necessary material, shelfs (5.1) and drawers (5.2), arc-shaped sliding out to both sides, are provided. For adapting further components the warming bed can be upgraded with a support (5.3) and a tube assembly Ø 27 mm (5.4). Refer to page 19.

* Depending on model and configuration

D2131_01

8/34

Walls 170 mm high

Instructions for use Neonatal warming bed THERMOCARE K

Use Symbols and warnings for use The following symbols used for the neonatal warming bed and its the accompanying documents: General Symbol

Meaning

Symbol

Meaning

Attention, observe warnings

Year of production

Observe instruction for use

Model- / article number

Do not dispose in domestic waste

Batch / lot

Manufacturer

Serial number

Under-pad heating device* Symbol

Meaning

Symbol

Meaning

The underpad heating device must only be used with the gel pad.

Heating pulse

Heating On / Off

Extended temperature range

Enter/Confirmation

Deviation from selection

Exented temperature range

Safety shutdown

Audio alarm pause

Power failure

General •

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

•

Do not use the warming bed close to high-frequent radiation sources such as HF surgery devices, mobile phones or similar.

•

Never use inflammable disinfectants!

•

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

•

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 at regular intervals or monitored.

•

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.

* Depending on model and configuration

D2131_01

9/34

Instructions for use Neonatal warming bed THERMOCARE K •

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" in their latest version must be observed, in particular the permissible limit values for the total sum of leakage currents. The max. power input is specified at the take-off sockets and must be considered.

•

Take care that the patient is never unattended when one or more walls (4.2/4.3) of the bed 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 the distance to accessories, which are not fixed at the neonatal warming bed, will change 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 carries the following warning symbol: The device must only be used with gel pad.

•

The under-pad heating device must be used with the original Weyer gel pad WY0620 only. Using other kinds of pads will influence the temperature characteristics negatively.

•

The surface of the under-pad heating device must be checked for mechanical damages prior to each operating.

•

The gel pad does not allow electrostatic discharge, 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.

•

Heating up the bed 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.

•

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, the PU pad WY0628 must be used instead of the gel pad or for isolation purposes a foam pad or woollen nappy, at least 2 cm thick, must be placed between patient and gel pad.

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.

* Depending on model and configuration

D2131_01

10/34

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 and accessories of the warming bed must be checked for correct and secure position as well as for correct function. The surface of the under-pad heating device must be checked for mechanical damages prior to each operating. 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 bed.

Prior to operation the warming bed must be prepared in cold condition according to chapter "Cleaning and disinfection" (page 25).

Function check of the moving mechanical components Make sure that no items or devices are placed within the height-adjustment range. adjust the bed with the foot pedals (1.1) to the lowest and then to the highest position. Unlock the catch (2.2) below the frontside of the bed by pulling and tilt the bed 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 bed is fixed in this position. For checking the functions of the 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 acquaint yourself with the following control elements and displays.

* Depending on model and configuration

D2131_01

11/34

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 rotary 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 bed will heat-up, when it does not light, the bed 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 bed 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.

* Depending on model and configuration

D2131_01

12/34

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, push button (3.15) right hand below the bed.

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.

* Depending on model and configuration

D2131_01

13/34

Instructions for use Neonatal warming bed THERMOCARE K

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 rotary 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 the rotary 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 bed 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. 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.

* Depending on model and configuration

D2131_01

14/34

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 21 to 24. 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.

Pause audio alarm. 2.) Watch the patient's temperature.

2.)

(Possibly sunlight, external warming devices?)

Interruption of power supply.

Yes

3.)

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

Permanent

No

Dark

Dark

Red

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

Patient cools down and becomes hypothermic.

> 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 -,-

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

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.

* Depending on model and configuration

D2131_01

15/34

Instructions for use Neonatal warming bed THERMOCARE K

Hazard/ Error condition

Alarm priority

Bed is warmer than 40°C.

High

Intermittent

Bed is warmer than 40,5°C.

High

Permanent

Warning lamp

Temperature display Selection

Actual

Yes

● > 40°C

E.g.

E.g.

No

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 bed will not cool off, 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.

Relay deenergized. Patient may cool off and become hypothermic.

Relocate patient.

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 influence, it must be switched off by the central on-off switch button (3.15), right hand below the bed.

* Depending on model and configuration

D2131_01

16/34

Instructions for use Neonatal warming bed THERMOCARE K

Bed with wall assembly Move the bed to the desired working level* with the foot pedals (1.1). Take off the canopy * (4.5). Cover the gel pad (3.1) with a cloth as thin as possible. Take care that the cloth does not block the walls and their locking system. The walls (4.2/4.3) must always close smoothly and latch securely. The safety side walls (4.1) should be inserted in a way that the patient cannot fall from the bed. For better accessibility they can be taken out of their support and inserted again set off by 180°. So the walls are retracted into the bed, allowing full access to the patient. Cables and tubes connected to the patient must exclusively be passed through the grommets in the rear wall (4.4).

Heating up the bed 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. When the under-pad heating device is at operation temperature, place the patient on the pad (3.1). Take care that the walls are folded up so that the patient cannot fall from the bed. Make sure that no body parts of the patient, cables of additional devices and tubes are squeezed. Attach the canopy (4.5)*, if necessary. After unlocking the catch (2.2) tilt the bed to the desired position. After releasing the catch check whether it has locked and the bed is fixed.

* Depending on model and configuration

D2131_01

17/34

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? Heat is withdrawn from the patient

For a mature unclothed infant a temperature of approx. 36.5°C should be selected. For a pre-term neonate a temperature of approx. 37° to 37.5°C is recommendable. For clothed infants the 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 at 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 isolation 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.

* Depending on model and configuration

D2131_01

18/34

Instructions for use Neonatal warming bed THERMOCARE K

Device models and mandatory accessories Order No.

Description Base devices

WY3001

Warming bed THERMOCARE K, fixed-height trolley, under-pad heating.

WY3002

Warming bed THERMOCARE K, height-adjustable trolley, under-pad heating.

WY3021

WY3022

Wall assemblies (mandatory) Wall assembly with hinges, consisting of: • 4 walls 250 mm high can be folded down with one hand. • Rear wall with 3 silicon grommets for plane passing of cables and tubes. • 2 safety side walls, retractable into the bed. Wall assembly, consisting of: • 4 walls 170 mm high can be folded down with one hand. • Rear wall with 2 silicon grommets for plane passing of cables and tubes. • 2 safety side walls, retractable into the bed.

Optional upgrade items / accessories Order No.

Description

WY3024

PMMA canopy (one-piece), for wall assembly 250 mm high, with recessed grips and temperature indicator. PMMA canopy (two-piece), for wall assembly 250 mm high, with recessed grips and temperature indicator. Shelf fixed at the pillar of the warming bed, (without drawer max. 4 pcs. possible. with drawer max. 2 pcs. possible). Drawer, fixed at the shelf WY3035, volume 400 x 150 x 160 mm, load 3 kg, arc-shaped sliding out to both sides (max. 2 pcs. possible). Additional pair of foot pedals for height adjustment. Support for adapting 2 tubes Ø 27 mm, necessary for mounting accessories. Tube assembly Ø 27 mm, length 650 m, fixed at the support WY3051. Necessary for mounting accessories. Instrument and monitor shelf 590 x 320 mm, fixed at the tube assembly Ø 27 mm, with instrument rail 25 x 10 mm and fixture for the canopy*. Instrument and monitor shelf 240 x 300 mm, fixed at the tube assembly Ø 27 mm, with 2 instrument rails 25 x 10 mm and fixture for the canopy*. Instrument rail 25 x 10 mm, 460 mm length, fixed at the tube assembly Ø 27 mm. Infusion holder, height-adjustable, fixed at the tube assembly Ø 27 mm. Holder for four-poster, plugged in support WY3051

WY3025 WY3035 WY3036 WY3032 WY3051 WY3055 WY3060 WY3061 WY3064 WY2076 WY3070 WY2016

Phototherapy BILICOMPACT® LED Phototherapy lamp for the treatment of neonatal hyperbilirubinemia, operating with modern LED Technology, ≤ 20 dB(A). Wave length range 460 - 490 nm according to the requirements of the American Academy of Pediatrics (AAP). The intensity is adjusted in 5 steps and displayed. Integrated timer (therapy can be interrupted), stop watch, examination light. Rubber feet for placing the lamp on the warming bed (canopy WY3024 required).

* Depending on model and configuration

D2131_01

19/34

Instructions for use Neonatal warming bed THERMOCARE K

Additional devices The "General requirements for the safety of medical electrical systems EN 60601-1-1 + Supplement A1" must be observed. Furthermore the maximum permissible power consumption for additional devices is specified at the take-off sockets and must be considered. The limit values of the total leakage currents must be maintained. It should also be considered that the distance to accessories, which are not fixed at the neonatal warming bed, will change and therefore connected lines and tubes might be pulled off.

* Depending on model and configuration

D2131_01

20/34