Drager 8000 NC User manual

Incubator 8000 NC

Instructions for Use – Software 11.n –

1-151-94

Contents

Page

For Your Safety and that of Your Patients................. 3

Intended Use.............................................................. 4

Preparation.................................................................5

Before using for the first time....................................... 5

Doors, ports and bed...................................................5

Connecting air temperature sensor.............................. 8

Fitting accessories ......................................................8

Preparing oxygen therapy accessories........................12

Routing cables and hoses.......................................... 13

Checking Readiness for Operation.......................... 14

Before using for the first time..................................... 14

Before each use.........................................................14

Page

Maintenance Intervals...............................................42

Disposal of NiCd batteries..........................................42

What's What..............................................................43

Technical Data..........................................................47

Description............................................................... 49

Design....................................................................... 49

Alarm hierarchy.......................................................... 50

Order List..................................................................51

Index......................................................................... 53

Operation..................................................................17

Precautions................................................................17

Controlling air temperature.........................................20

Using skin temperature control .................................. 23

ThermoMonitoring......................................................28

Using humidity control ...............................................29

Supplying oxygen.......................................................31

Using electronic baby scales...................................... 32

Using vacuum mattress.............................................. 32

Using phototherapy unit..............................................33

Using "BabyLink Incubator" interface......................... 33

Care.......................................................................... 34

Stripping down...........................................................34

Cleaning/disinfecting/sterilizing.................................. 35

Before re-using.......................................................... 37

Fault, Cause, Remedy...............................................38

For Your Safety and that of Your Patients

For correct and effective use of the apparatus and to avoid hazards it is essential to read the following recommendations and to act accordingly1):

Strictly follow the Instructions for Use

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.

Maintenance

The apparatus must be inspected2) and serviced2) regularly by trained service personnel at six monthly intervals (and a record kept). Repair2) 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 maintenance2). Observe chapter "Maintenance Intervals".

Liability for proper function or damage

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.

Drägerwerk Aktiengesellschaft 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 Drägerwerk Aktiengesellschaft are likewise not modified by the recommendations given above.

Drägerwerk Aktiengesellschaft

Power connection

The apparatus is to be used only in rooms with mains power supply installations complying with national safety standards (such as in F. R. of Germany: VDE 0107).

The requirements laid down in IEC 601-1 "Safety of Medical Electrical Equipment" are applicable for electrically powered equipment.

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.

Safe connection with other electrical equipment

Electrical connections to equipment which is not listed in these Instructions for Use should only be made following consultations with the respective manufacturers or an expert.

1) Insofar as reference is made to laws, regulations or standards, these are based on the legal system of the Federal Republic of Germany.

2) Definitions according to DIN 31 051: Inspection = examination of actual condition Service = measures to maintain specified condition Repair = measures to restore specified condition Maintenance = inspection, service, repair

Intended Use

Heat therapy for premature babies and sick neonates; with control of air temperature and humidity; and also skin temperature as an option.

The incubator must only be used by properly trained staff under the supervision of qualified medical staff who have up-to-date knowledge of the risks and benefits of the use of incubators.

Do not use the skin temperature control on babies who are in shock or who have high temperatures.

The air in the incubator should only be enriched with oxygen when prescribed by a doctor. It is absolutely essential that such oxygen enrichment is controlled on the basis of the arterially-measured oxygen partial pressure in the patient's blood. If this is not done there is a risk of hyperoxaemia (damage to the eyes) and hypoxaemia (damage to the brain).

Do not nebulize any medicaments or similar substances in the patient's room. If nebulized

substances fall onto the incubator this may impair its functioning.

Mobile telephones must not be used within 10 metres of the incubator.

Mobile telephones may interfere with the functioning of electro-medical equipment.

Maximum load must not exceed 25 kg.

Only connect incubator to a mains power socket. Do not use a mains distribution board.

If there is a circuit breaker in the supply to the distribution board the permitted limit for leakage currents might be exceeded. There could then be an electrical risk for patient and staff.

Preparation

The incubator is supplied fully assembled.

Before using for the first time

● Check that all packaging material has been removed.

Doors, ports and bed

Front door

To open front door:

Preparation

Before using for the first time

Doors, ports and bed

1 Squeeze catches together with thumb and index

finger and at the same time lower front door until it rests on housing.

To close front door:

● Lift up front door.

1 Squeeze catches together on both sides, push front

door forward and release catches. Push firmly on front door to ensure that catches fully engage. Red mark on catches should no longer be visible.

Divided front door, optional

To open front door:

● Squeeze catches on both sides together, and at

the same time fold upper section back until it rests on sloping surface of canopy. It is then possible to attend to the patient.

If necessary:

● Pull lower section down, pulling gently against pivots

to do so, and lower until it rests on housing.

1 1

To close front door:

● First lift up lower section and push back into place –

until it engages.

● Then fold upper section down and, while squeezing

catches on both sides together, push door back into place – until it engages. Red mark on catch should not be visible any more.

Preparation Doors, ports and bed

To open hand ports: 1 Press catch on serrated area to open hand port.

To close hand ports:

● Push hand ports back into place until catch is safely

engaged.

Canopy

To lift up canopy:

● Open front door.

● Tip canopy back as far as it goes.

Taking out the bed

● Open front door.

● Pull bed out forwards until it stops.

● After completing care procedure, push bed back as

far as it will go and close front door.

Tilting the bed

● Raise left lever until it engages to lift left end of bed.

● Raise right lever until it engages to lift right end of

bed.

● Lift bed end as required.

Incubator 8000 NC

Re-positioning bed end

Can be used at right or left end of bed, as required.

● Open front door.

Preparation

Doors, ports and bed

1 Push middle of bed end outwards until it is released

from the groove and

● re-position at other end of bed.

● Close front door.

Double wall on front door

e. g. when cleaning the incubator

● Open front door.

2 Disengage double wall from upper bracket and

remove.

● After cleaning refit the double wall by gently pushing

back until it engages again; close the front door.

Removable double walls, optional

When older children are being treated, heat production is greater and the temperature in the incubator may become too high – the double walls should then be removed.

Incubator 8000 NC

To remove:

● Disengage double wall from upper bracket and

remove.

To put back:

● Open front door.

● Fit double wall to clips provided, raise and

● engage in upper bracket.

● Close front door.

Bed extension Required when the rear double wall is not being used

to reduce risk of patient being trapped.

● Open front door and pull out bed.

3 Push both ends of bed extension out slightly and 4 click on the rear side of the bed.

Make sure that the bed extension is securely atteched.

● Replace bed in incubator.

Do not use bed extension when the rear double wall is in place as the incubator temperature may be affected.

Preparation Connecting air-temperature sensor Accessories

Connecting air temperature sensor

● Push air temperature sensor plug through slot in the

incubator housing, from below and

1 push into socket until it engages. 2 Route sensor cable through cable clips.

Fitting accessories

Support for ventilation hoses

● Fold down front door.

● Raise bed and lift out of incubator.

● Push mattress to one side a little.

Push hose support into appropriate hole, right or left.

● Screw knurled screws on from below and tighten.

● Replace bed in the incubator and close front door.

Fitting rail

Rail is used to hold

Bronchial suction equipment Instrument tray Mounting plate for ancillary equipment Infusion stand Oxygen therapy equipment

● Screw rail to left or right side of housing with Allen

screws.

Maximum load must not exceed 25 kg.

Bronchial suction equipment

See also relevant Instructions for Use.

To mount on incubator

● Attach holder to one of the rails using rail clamp.

● Hang cylinder holder on it.

● Attach ejector to rail with rail clamp.

Preparation

Accessories

● Connect hose.

Instrument tray

(for small items)

● Attach tray to rail and tighten clamp. Maximum load

must not exceed 2 kg.

Incubator 8000 NC

Mounting plate

For monitor and ventilator with latching system for standard Dräger housings 1/2 B, e. g. Dräger Babylog 8000.

Maximum load must not exceed 20 kg.

● Attach plate to rail and tighten clamp.

Fixing equipment to mounting plate Example: Dräger Babylog 8000

● Remove foot strips from Babylog.

● Tilt Babylog forward by about 45°.

1 Insert front latches into slots in mounting plate. 2 Lower Babylog, insert the rear latches into slots in

mounting plate and secure at back with knurled screws.

Incubator 8000 NC

Preparation Accessories

BabyScreen

Optional for ThermoMonitoring

● Attach holder to rail.

● Engage BabyScreen in holder.

● Follow relevant assembly instructions.

Infusion stand

● Attach stand to rail with rail clamp and tighten.

Incubator 8000 NC

Fitting pillar

● Screw pillar to left or right of housing, as required.

● Secure pillar with allen screw.

Incubator 8000 NC

Attaching infusion bottle holder to pillar

● Attach clamp for infusion bottle holder to pillar and

tighten using tommy screw.

Preparation Accessories

Swivel table

For small items, maximum load = 3 kg

● Attach clamp on swivel table to pillar and tighten

screw. Make sure that swivelling area is clear.

Swivel cupboard, optional

To fit a swivel cupboard:

Incubator 8000 NC

● Push Allen screw up through unit from below and

screw firmly to unit mounting.

● Insert extra drawers.

● Store whatever is needed in them.

The maximum load on the incubator must not exceed 25 kg.

Incubator 8000 NC

Preparation Preparing oxygen therapy accessories

Preparing oxygen therapy accessories

– for oxygen enrichment of incubator air – for oxygen enrichment using a head box

● Follow Instructions for Use of equipment used.

● Monitor O2 concentration

O2 flowmeter

● Attach O2 flowmeter to rail.

● Fit hose to connector on O2 flowmeter and

● to O2 connection underneath incubator.

● Push probe on O2 connecting hose into terminal unit,

only as far as "parking position" initially.

Oxygen limiter

If an oxygen limiter is going to be used:

● Unscrew connector on O2 flowmeter and screw

oxygen limiter on.

● Connect hose.

O2 meter

Incubator 8000 NC

Monitor O2 concentration with O2 meter which has alarm limits, e. g. Dräger Oxydig:

● Attach O2 Oxydig meter to rail with meter bracket.

● Place sensor capsule in incubator.

● Route sensor cable through one of the flexible hose

seals. Push sensor plug into socket on Oxydig until it clicks into place.

Incubator 8000 NC

Oxygen distributor

● Attach oxygen distributor, order no. 2M 18 810, to

rail.

Preparation

Oxygen therapy accessories

Cables and hoses

Routing cables and hoses

● Route hoses and cables through the flexible hose

seals.

Incubator 8000 NC

● Push ventilation hoses and cables into clip at end of

hose support.

Checking Readiness for Operation Before using for the first time Before each use

Checking Readiness for Operation

Before using for the first time

● Check that the mains voltage corresponds to the

specification on the rating plate.

Before each use

● Check that the equipment has been disinfected.

● Check that the calibration seals on the front of the

equipment and on the skin temperature sensor are still valid (only required in Germany).

● Check that an adequate gas supply is available for the

equipment to be used.

● Check that the accessories and therapy equipment

required are to hand and in perfect condition. Check readiness for operation in accordance with relevant Instructions for Use.

● Check that the incubator canopy has no cracks or

sharp, chipped edges.

● Check that the hinges and pivots on the canopy are in

proper working order.

● Check that the cables and hoses are routed correctly

and safely.

● If the rear double wall has been removed: Check that

the bed extension is provided. See page 7.

● Connect to mains power supply.

Do not use a mains distribution board.

[

If there is a protective circuit breaker in the supply to the mains distribution board, the permitted limit value for leakage currents might be exceeded. There could then be an electrical risk for patient and staff.

Checking that hand ports will stay closed

● Open each hand port and then close carefully until

catch engages.

Checking Readiness for Operation

Before each use

1 Grip rim of closed hand port and pull outwards – it

should not open.

If the hand port does not remain engaged:

● Call DrägerService.

Checking that front door will stay closed

● Open front door.

● Lift up front door again.

2 Squeeze catches together on both sides, push front

door forward and release catches. Push firmly on front door to ensure that catches fully engage. Red mark on catches should no longer be visible.

If the front door does not engage:

● Call DrägerService.

Checking air filter 3 Open filter cover plate downwards.

If a filter is fitted:

● Remove filter and check fitting date; label is on edge

of filter.

If filter is more than 2 months old:

● Replace with a new filter.

● Write fitting date on new filter label and stick to edge

of filter.

● Press filter firmly into the seal.

Make sure that the direction of flow through filter is correct. Arrow on filter has to point into incubator.

● Close cover plate.

Testing tilting mechanism for bed 4 Raise left end of bed to maximum height. 5 Push down on raised bed with hand – bed must not

drop down.

If bed does drop down:

● Call DrägerService.

● Check tilting mechanism at right end of bed in the

same way.

Incubator 8000 NC

Checking Readiness for Operation Before each use

Activating incubator self-test 1 Push on/off switch in – until it engages = on.

Functioning of incubator is self-tested.

2 Green LED is lit. 3 Display of actual values shows dashes.

If Err is displayed = error, see p. 39 to 41.

Checking mains power failure alarm and NiCd batteries

● Disconnect from mains.

4 Red N LED is lit. Continuous sound commences.

The volume should remain constant for at least 30 seconds.

If the volume decreases too soon:

● Leave incubator connected to mains and switched on

for 24 hours for the NiCd battery to be charged.

°C HAUT/SKIN/PEAU/PIEL °C LUFT/AIR

15.22

87.06

Control

°C

±1,5 °C

Sensor

°C

Reset

°C

± 0,5 °C

Sensor

°C

Check

36 °C

±0,1

°C LUFT/AIR

°C

>37 °C

Control

Reset

Control

>37 °C

Control

Check

Inop.Control

Check

● Repeat check.

If volume decreases too soon again:

● Call DrägerService.

Checking LEDs, displays and alarm sound 5 Press k key:

For about 2 seconds – all LEDs are lit (except the mains power failure LED), the digital displays show

88.8 and alarm sound commences. Thereafter, displays and LEDs go dark and alarm

sound ceases. After approximately another 2 seconds the original displays for measured and set values reappear.

This check may also be carried out during operation.

● Check at least once daily.

If there is a fault: Call DrägerService.

°C LUFT/AIR

°C

Reset

>37 °C

Control

Check

The incubator is ready for operation when all checks have been carried out successfully.

Operation

Precautions

Operation

Precautions

Warming-up time

Allow adequate time for warming-up before placing the baby in the incubator (about 35 minutes). Recommendation: operate incubator in standby, see p. 19.

Do not cover air stream channels in base plate: Danger of burning or cooling patient.

Controlling temperature of incubator

– Temperature may be increased very rapidly when

required because of high heating power.

– Temperature drops slowly because of good thermal

insulation.

Additional external heat sources, such as sunlight, heat lamps, spotlamps, electric cushions should be avoided. These increase the air temperature inside the incubator in an uncontrolled manner.

Setting air temperature of incubator

The baby experiences minimal heat loss – by convection because of low air speed across bed – by conduction through the mattress – by evaporation because of high humidity setting in

incubator.

Therefore, compared with other incubators, such as the Incubator 6000 or 7000, a lower incubator air temperature can be set.

The baby's core temperature must be monitored continually, particularly during the first few hours of incubator care.

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