Dräger 8000 NC User manual

Incubator 8000 NC
Instructions for Use
- Software 11 .n —

Contents
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
2

For Your Safety and that of Your Patients
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 recom¬
mendations and to act accordingly 1 ) :
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 inspected 2 ) and serviced 2 ) regu¬
larly by trained service personnel at six monthly intervals
(and a record kept).
Repair 2 ) and general overhaul of the apparatus may only
be carried out by trained service personnel.
We recommend that a service contract be obtained with
DragerService and that all repairs also be carried out by
them. Only authentic Drager spare parts may be used for
maintenance 2 ).
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 DragerService
or if the apparatus is used in a manner not conforming to
its intended use.
Dragerwerk 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
Dragerwerk Aktiengesellschaft are likewise not modified
by the recommendations given above.
Dragerwerk 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. ^
Insofar as reference is made to laws, regulations or standards, these
are based on the legal system of the Federal Republic of Germany.
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.
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
3

Intended Use
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.
4

Preparation
Before using for the first time
Doors, ports and bed
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:
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.
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.
5

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.

Preparation
Doors, ports and bed
Re-positioning bed end
Can be used at right or left end of bed, as required.
• Open front door.
1 P ush 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 D i sengage 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.
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.
7

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.
8

Preparation
Accessories
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.
• Connect hose.
Instrument tray
(for small items)
• Attach tray to rail and tighten clamp. Maximum load
must not exceed 2 kg.
Orager Incubator 8000 NC
Mounting plate
For monitor and ventilator with latching system for
standard Drager housings 1/2 B, e. g.
Drager Babylog 8000.
Maximum load must not exceed 20 kg.
• Attach plate to rail and tighten clamp.
Fixing equipment to mounting plate
Example: Drager 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.
9

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.
Fitting pillar
• Screw pillar to left or right of housing, as required.
• Secure pillar with alien screw.

Preparation
Accessories
Attaching infusion bottle holder to pillar
• Attach clamp for infusion bottle holder to pillar and
tighten using tommy screw.
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:
• 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.
11

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 02 concentration
O 2 flowmeter
• Attach 02 flowmeter to rail.
• Fit hose to connector on 02 flowmeter and
• to 02 connection underneath incubator.
• Push probe on 02 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 02 flowmeter and screw
oxygen limiter on.
• Connect hose.
O 2 meter
Monitor 02 concentration with 02 meter which has alarm
limits, e. g. Drager Oxydig:
• Attach 02 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.
12

Oxygen distributor
• Attach oxygen distributor, order no. 2M 18 810, to
rail.
Routing cables and hoses
• Route hoses and cables through the flexible hose
seals.
• 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.
14

Checking Readiness for Operation
Before each use
Checking that hand ports will stay closed
• Open each hand port and then close carefully until
catch engages.
1 G r ip rim of closed hand port and pull outwards - it
should not open.
If the hand port does not remain engaged:
• Call DragerService.
Checking that front door will stay closed
• Open front door.
• Lift up front door again.
2 S queeze 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 DragerService.
Checking air filter
3 O pen 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 edqe
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 DragerService.
• Check tilting mechanism at right end of bed in the
same way.
15

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.
"A
°C LUFT/AIR
S o □□
o
o
o
o
□ 2
□ • • 1
Checking mains power failure alarm and NiCd batteries
• Disconnect from mains.
4 Red =0- 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.
• Repeat check.
°C LUFT/AIR
0
0
0
A
O
O
• 4
0
□
\
-
OO''
0 0 -- ■
O
i PO
If volume decreases too soon again:
• Call DragerService.
Checking LEDs, displays and alarm sound
5 Press @ 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 re¬
appear.
This check may also be carried out during operation.
• Check at least once daily.
If there is a fault:
°C LUFT/AIR
0
0
0
>
0
0
0
0
□
0 0
0 0 _-
—
■ s °0
_ J
Call DragerService.
The incubator is ready for operation when all
checks have been carried out successfully.
16

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.
17

Operation
Precautions
Reducing the internal temperature of the incubator
The cooling time is dependent on the design and can be
accelerated by:
- reducing the outside temperature (when possible)
- reducing the air-humidity setting.
The rate of cooling is not accelerated by:
- setting the air temperature to a lower value than is
actually required.
In urgent cases: open front door or hand ports. When
front door is opened, there must be continuous
supervision to make sure that the baby does not fall out.
Fire risk from oxygen
- No naked lights or smoking. Textiles, oil and plastics
can very easily catch fire and burn rapidly in an
oxygen-enriched atmosphere.
- Keep all fittings and seals in contact with oxygen free
of oil and grease.
- Open valves on 02 cylinders slowly.
- Do not use an incubator where there are flammable
anaesthetic gases or disinfection agents.
Risk of explosion.
- Do not use or keep flammable liquids, such as
alcohol, ether and acetone in the incubator.
- Do not use any electrical equipment inside the
incubator, except, that is, for equipment expressly
designed for use in areas where there is a risk of
explosion.
Physiological risks from oxygen
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 blood of the patient. This is the only
way of avoiding both hyperoxaemia (damage to the
eyes) and hypoxaemia (damage to the brain).
Temperature of breathing gas
During ventilation the breathing-gas hoses may become
too warm from the heated air circulating in the incubator.
The temperature of the breathing gas must be monitored.
Phototherapy in the incubator
Absorption of light through the baby's skin will supply
heat which may increase the baby's core temperature.
Therefore,
• Decrease temperature setting for incubator air by
about 2 °C 15 minutes before phototherapy.
• Decrease the set value for humidity.
• Reduce the room temperature to at least 3 °C below
the air temperature of the incubator.
This value applies for Drager 800/8000/4000
phototherapy units.
Other phototherapy units, particularly those without a
built-in fan, may cause even greater heating of the
incubator.
The core temperature of the baby must be monitored
with particular care during phototherapy.
The supply of fluids to the baby must be increased
e.g. by parenteral infusion, in order to compensate for
increased loss of water during phototherapy.
The phototherapy lamp and incubator canopy must
not be covered with cloths, aluminium foil, or other
materials, to boost the photo-therapeutic effect.
Risk of heat build-up. The incubator could not then be
adequately cooled with ambient air.
Danger of overheating the patient.
Preventing high noise levels
Noise levels that are too high for the patient may be
caused by:
- using head boxes to deliver pressurised gas,
- wear on the bearings of the fan motor,
- placing objects on the incubator canopy.
• Observe maintenance intervals, p. 42.
• Do not place anything on the incubator canopy.
Electrical safety
Use only electro-medical ancillary equipment which
complies with the IEC 601 -1, EN 60601-1 or DIN
VDE 0750, part 1, regulations.
18

Operation
Wait for warming-up time.
Wait for about 35 minutes before use.
• Heat incubator in "air temperature control" operating
mode.
If incubator has to be used urgently:
• Operate incubator in standby mode:
Set air temperature to 32 °C to 36 °C,
see p. 20, and set humidity control to 0, see p. 30.
Just before placing the baby in the incubator:
Fill water container
• If required use protective gloves.
1 Take cover of water container off and
2 fill container to mark with clean, distilled or
demineralised water (hospital dispensary).
Do not use any additives.
Take care not to overfill.
• Put cover of water container back.
• Then disinfect hands.
If water bottles are used:
Fill water bottles
• If required use protective gloves.
1 Open back panel and fold down.
2 Disconnect empty water bottles and refill with 500
clean, distilled or demineralised water (hospital
dispensary). Do not use any additives.
• Refit filled water bottles and close back panel
again.
• Then disinfect hands.
Placing baby in the incubator
• Open front door and pull out bed.
• Put the baby on the bed and slide the bed back in
position.
• Close the front door and check that the catches are
properly engaged.
• Adjust the bed as required.
19

Operation
Controlling air temperature
Controlling air temperature
Measure the patient's core temperature at regular
intervals.
1 Push on/off switch in - until it engages = on.
2 Green LED is lit.
• Wait for self-test to finish, then incubator will switch to
"air temperature control" mode.
3 The display alternates regularly between measured
value for air temperature and the word, SEt.
4 Default value for flashing display of air temperature set
value is 33.0 °C.
5 P ress (7] or (7] key briefly to select this set value.
The display will remain continuously lit.
°C LUFT/AIR
°
°
o
'\
o
o
o
o
■ ■ □
° 5 ° LJ ( )
□ °o
_/
Setting values in 28 °C to 37 °C range
The set value can be changed in 0.1 °C steps.
6 Press (T] key - the set value is decreased,
7 Press (7] key - the set value is increased.
• Press [7] or |T| key until the set value required is
reached.
8 While green LED flashes - incubator is in heating-
up phase.
20