Professional Documents
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UN-PACKING MANUAL
INSTRUCTION MANUAL
PPA-20161212-EN
Please keep these instructions always near the bed throughout its operation.
Every person operating the birthing bed must read and understand the contents
of these instructions.
Logo Meaning
Warning
Warning:
Dangerous electric voltage
Serial number
Product weight
Battery marking
Producer
Date of production
Equipotentiality
Packaging material:
“Keep dry”
Packaging material:
“Fragile!“
Packaging material:
“This side up”
Temperature limitation
Transportation marking:
„Relative air humidity“.
Transportation marking:
“Air pressure”.
Cardiopulmonary resuscitation
IT Information technology
PC Personal computer
Cut through the tape around the box and remove the trapeze.
Cut the tape on the tray and gradually remove all the accessories.
All wheels rotate in the direction to the longer end of the palette and lock wheels
in the direction.
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Put polystyrene runs to the edge of the palette. Gently push down on the bed in
the direction of the arrows. Go down from the palette.
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1. Lift high plastic cover (A) and remove low plastic cover (B).
2. There are electronical components under the plastic cover. Plug in
connector C into position D (marked as „BAT“) in controlbox unit.
3. To plug in the connector into position D in controlbox, it is necessary to lift
the plastic cover of connectors. It is necessary to put the plastic cover into
original position after the connector is plugged in.
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9
1
7
11
10
6
3 16
4
5
14
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13 15
1. bed part, for version BX with massaging segment, for version CX with
lumbar segment
2. seat section
3. foot section
4. castor, directional 1x
5. castor with brake 3x
6. plastic covers of chassis
7. leg rest with new system of joint control
8. headrest adjustable by sliding on the back
9. handle of back part
10. eurolath along seat section
11. tray on swinging holder
12. control lever for positioning of foot section in horizontal position
13. security screw of holder of leg rest
14. protective ledge of the plastic cover of chassis
15. control light for power supply
16. holder for infusion stand
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2.2 Safety
Standards
The product meets the requirements of valid standards EN 60 601-1 and EN
60 601-1-2
According to the Directive on Medical instrumentation 93/42/EEC the birthing
bed is classified as medical instrument of 1st class.
Function
The essential functions are lying, sitting and supporting the woman in
labour. Additionally, it is the CPR position.
Delivery bed is used by mothers before and during delivery. A bed equipped
with adequate accessories offers birth mothers the opportunity to take up their
optimum position for birth. Delivery bed can be used together with a set of
cushions.Before use it is necessary to disinfect the bed with common
disinfectant solutions, place a hygienic cover over its washable surface using
typical draping. Positioning and handling the bed is not an obstacle in providing
health care. Handling the foothold part, especially by retracting it (fast way to
store it under the seat/back part) at the end of the second stage of delivery it is
possible to create more space to perform obstetrical and vaginal surgeries and
it is also useful for practical training of medical students and midwives.
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The upper handle on the backrest can, in some cases (given the
customs of a particular school or workplace) provide slightly worse
access for the anaesthesiologist to the patient.
For a Caesarean section it is necessary to remove the trapeze bar from
the delivery bed and lower the foot section to the lowest position.
Indication
Contra-indications
A relative contra-indication is the use of the delivery bed for elective Caesarean
sections (planned) when it is planned to perform the surgery in a standard
operation room with adequate equipment.
Interaction
When using the delivery bed as part of the medical system, certain elements
(medical devices) may interact. Before this application it is necessary to follow
recommendations provided in the user manual of the delivery bed.
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The birthing bed may only be operated where the conditions of valid standards
for el. distribution in medical facilities are met. According to the Act on Means of
Medical Instrumentation the product may only be operated by persons with
adequate qualification.
Performance of servicing works: BORCAD Medical a.s. authorized service may
only responsibly evaluate the safety technological features if the operators,
repairs, alternations, etc., had been performed only at the producer authorized
locations and the product is operated in full conformity with the instruction
manual. Birthing bed should not be used if there are obvious mechanical
defects of upholstery, covers and other supporting parts.
General safety:
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Since the unit is powered from the network, it may cause interference
with sensitive equipment due to generation of electromagnetic field. In
order to reduce the influence of undesired electromagnetic effects, the
bed was designed in compliance with ČSN EN 60601-1-2. To prevent
the occurrence of these problems the bed must be used in compliance
with this manual.
If there is a fluctuation in the voltage range (+/- 20 V) then it is
necessary to connect the product to voltage regulator. Otherwise the
electronics can be damaged.
To avoid risk of electric shock, this chair must be connected to power
main with Protective earthing
The chair must be positioned in such way, so if its necessary could be
immediately disconnected from the power main
Modifications to this chair is forbidden
Before plugging check the power cable for mechanical damage.
Before plugging in check the voltage of the network for conformity with
information on the type label of the bed. A plugged-in bed is indicated by a
green control light on the foot of the bed.
Power cable of the bed must not be connected through an extension cord
but directly into the power socket.
Avoid hanging the power cable over moving parts of the bed. When
accumulators are in use, the cable may be damaged!
No input cable of this or other devices can lead over the bed and /or over
the patient.
Within the space of 1.5 m, within the patient space, only medical equipment
meeting standard EN 60601-1 or medical equipment with certification
according to IEC may be used.
Birthing bed is not intended for use in areas enriched with oxygen
(concentration higher than 25% or partial pressure reaching 27.5 kPa).
The birthing bed is intended only for use by medical professionals.
The birthing bed may cause radio interference, which can have effects
on the operation of nearby equipment. It may be necessary to take
measures to reduce these effects, such as redirection, relocation or
shielding of the device.
Interference is possible in the vicinity of devices marked with the
following label.
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Before the mother in labor accesses the bed, the wheel brake must be
engaged!
The bed is not designed for mothers over 210 kg.
No objects that may collide with the bed may be located near it (furniture,
stands etc.)
Never enter the space under motor operated parts of bed (back, seat and
leg rests).
Before undertaking any resetting of the birthing bed check if no one is within
reach of the moving parts.
Before any resetting, check for kinked and/or tangled power cables
In case of failure of the control (permanent pressing of buttons or damage
to cable) the motor may be stopped by pressing the button for the opposite
direction of operation, and then it is necessary to unplug the power cable,
the batteries, and contact the service authority.
After setting the bed in place all brakes must be engaged so as to prevent
unwanted movement of the bed, e.g. during patient’s occupancy. When
setting the bed all four wheels have to be in contact with the floor and the
brakes engaged
Never step on chassis covers.
The birthing bed is not designed for permanent operation. - motors
can only be loaded up to the values defined on the label, i.e. 2 minutes
of operation followed by 18 minutes of stand by.
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No objects (furniture, stands, etc.) may be placed near the bed that
could collide with it (minimum distance of 20 cm). Movable parts of the
chair must be treated with caution. Movement of these parts can cause
collision with other objects, which may lead to damage to parts of the
chair or injury of the patient, staff or any third person!
The power cable must not be connected through an extension cord and it
must not be connected to common multisocket inlets.
No input cable of this or other devices can lead over the surfaces of the bed
A and /or over the patient. When moving the bed avoid pinching/kinking of
any objects.
Pay attention to proper fixing of the approved accessories listed in the
manual
Installation is done by trained person; operating the birthing bed only
allowed by trained personnel for routine functions; operators must be trained
on setting sufficient height of the infusion stand.
Training will be performed by a representative of BORCAD Medical a.s.
(manufacturer) or its official dealer
Maximum weight of the patient 210 kg.
A battery is a component of every obstetric bed; it is fully charged and
flawless and allows for the operation of the bed for the time of approx. 3
minutes. The battery is recharged automatically from the control unit and
does not require any special maintenance. If the chair is not connected to
the network for more than one week, it is necessary to disconnect the
battery connector from the CB (Control box). With internal rechargeable
battery system for all functions of the bed.
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The birthing bed also allows transporting the patient. This is, however, subject
to the following conditions:
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The delivery bed is fitted with four twin-wheels and it may be moved in all
directions. Wheel functions are controlled by two pedal brakes.
Setting of the wheel pedal under the back part on the side without lifting column:
Setting of wheel pedal under the back part on the side with lifting column:
In case of moving the delivery bed the power cable must be unplugged
and it is to be stowed away in the provided space to avoid the risk of
running over the cable by wheels and risk of electrical shock injury.
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Motors can only be loaded up to the values defined on the label, i.e. 2
minutes of operation followed by 18 minutes of stand by. In case of
overcharge automatic stop may be engaged. Under such conditions,
authorized service action is needed.
Components of the product are not treated against fire. Hence, avoid
handling near open fire. If this rule is not observed, the product may
catch fire
When handling the product, please pay attention to protection of power
cable against mechanical damage, especially its insulation
In case of fuse replacement pay attention to correct selection of fuse
type. Fuses need not be replaced by an authorized BORCAD Medical
a.s. it can be done by a qualified electrician.
Pay attention to free passage of hoses, cannulae, and other free parts (in
case infusions are used) so as not to get these pinched in the moving
parts of the product (armrests or leaning parts may be the risk locations)
When positioning the product, collision with objects may occur. Keeping
safe distance from other objects is recommended in order to damage
and injury.
After the power cable is plugged in, the operator may use the control panel to
set the height position of the seat and the backrest inclination.
The functions of the control buttons are shown in the following image. Buttons
for foot control are identical except for the option of lift of the bed. Motor setting
is done by pushing and holding the function buttons.
Lowering/lifting of seat
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The wireless foot controller ensures a remote radio transmission of signals for
activating movement functions of the AVE birthing bed. The remote control
transmitter is supplied by two ALKALINE batteries type LR14, size C, voltage
1,5 V, supposed minimum operating life is about half a year. Wireless foot
controller signal range is 5 m from the transmitter located in the bed base.
Equipment control:
For proper execution of chair movement, pressing (clutching down) and holding
corresponding button of the foot controller is necessary.
This controller is also equipped with a protective wire, which can be held to
carry the controller.
Signaling LED
diode
Tilt of back
section
Height
adjustment of
laying section
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Fig. A Fig. B
Fig. C Fig. D
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If all five positions have been saved but some new controller should be
assigned, all the controllers connected so far must be deleted from the receiver
memory. To delete them, please hold the matching button (use a non-
conducting object for this purpose) on AVE bed receiver and AVE wireless foot
control for the period of 5 seconds. Then wait another 5 seconds before you
start to match a new foot controller.
Error Messages
Error messages are indicated by means of a LED located on the mobile foot
controller. When operating the device, the following situations can occur:
Remote control does not work if the birthing bed is not connected to the
power network. It is recommended to replace the batteries every two
years!
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Change batteries.
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All versions of the obstetric bed are equipped with a backup battery.
Fig. 1
If the backup battery is fully dead, then it takes one hour to charge for
the minimum capacity enabling using the battery again. If you request
fully charged battery then it takes 10 hours.
Back up time - it is assumed 1-2 weeks depending especially on local
temperature. The warmer temperature is the longer backup time you
have.
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The CPR controller is marked with red information labels on both sides of
the back section. The labels are marked with CPR. The controllers are not
intended to be used as handles for transporting the bed. During annual
inspections, it is recommended to check the mechanism (removal of
springs and cords, loosening tolerances).
To activate the function, use one hand to push the red lever in the specified
direction. Use your other hand to pull down the back section by the back
handle.
Keep holding the lever during this movement. When the bed reaches horizontal
or Trendelenburg position, release the lever. The bed locks safely in this
position.
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Inserting/pulling out
Foot section may be in its low position turned along vertical axis and it may be
arrested in three positions:
Adjustment to any of these positions can be done after pressing the controller
with an arrow specifying the intended direction of pushing the control element
downwards and turning the foot section towards the operator. After releasing
the control, while turning the foot section, it will be automatically arrested in the
nearest position. If you wish to fluently pull out or push in the foot section
completely, just keep the control pressed.
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The surface of the completely pulled out foot section may be folded and lifted up
to the level of the seat. All listed positions of the foot section do not limit setting
of the birthing bed. Before loading the foot section its correct locking shall be
checked by short moves to the sides.
Unfolding upwards:
Folding down:
Pull the control lever with the left hand (Pic.1) and simultaneously push
the back edge of the foot section with the right hand until the foot section
reaches low position (Pic.2).
Pic. 2
Pic. 1
Before pushing the foot section in, under the seat, it must be in the
lowest position!
In case of putting away the cushioning of foot section away from the
structure of the bed, it must be placed on its broadest laying surface
(ground, table) In case of laying the foot section with its setting on the
side edge, the cushioning may be damaged due to higher weight of the
part.
When unfolding the foot section other person(s) shall not interfere.
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The legrests are single part units and may be used as leg supports or, after
readjusting, as feet support (footrests).
Holders of the legrests are inserted into square openings on the side of the seat
and they are locked by tightening the security screw on the bottom side of the
seat. The legrest may be removed from the AVE birthing bed by loosening the
security screws and removing, by pulling out, of the leg rests from the seat.
Setting of new leg rests is very simple, it is fast, safe and could be done using
two securing levers at each of the leg rests.
After releasing the upper securing lever the upper tray of the rests may be
secured as follows:
Locked
Loose
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Optimum setting of leg rests for mother in labor is allowed due to the
combination of upper and lower parts of the leg rests.
Leg rests may be set to so called “nonfunctioning” position along the leg part
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The leg supports are made of two parts, which are used together to ensure leg
support. If you remove the top part, you can still use the handgrips. In this
position the bed is best suitable for boarding.
Removal procedure:
1) Push the safety lock (Fig. 1)
2) Pull the top part of the leg support out of the locking mechanism (Fig. 2)
3) The bottom part remains in the chair in case you wanted to use the handgrips
(Fig. 3)
Fig. 1 Fig. 2
Fig. 3
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Fig. 1
For greater clarity, the foot rests are marked with coloured circles. The left
foot rest is marked with a grey circle. The right foot rest is marked with a
blue circle on the removable part as well as on the fixed one. It is
recommended to match the colour marks on the fixed and removable
parts so that the foot rests are not interchanged.
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Leg holders are two-piece, split and are used complete either as leg holders or
as foot supports, after removing the leg holder bowl you can use it as handrails.
Leg holders set into square holes on sides of seat part and secure with
safety screw – see pictures below.
After removig the leg holder bowl are leg holders as handrails:
Release the safete screw of leg holder bowl in direction B at least 3
rotations and remove the leg holder bowl in direction C.
Make sure that leg holders, when are not in use, must be turned
backward – direction E – and also must be secured by rotating lever in
direction D.
When driving down with the bed must be leg holders in upper
position.
When are leg holders tilt down can come to the collision with the bed
frame or with the floor!
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Hand holder for the leg rest may be inserted into the square holder, which is a
part of the leg rests. The holder automatically locks after inserting. Holder may
be removed by pushing the arresting lever in the direction of the arrow and
simultaneous pull of the holder upwards
To clean grab handle girdles, you can use a weak solution of soap, alcohol
cleaner or isopropyl alcohol. Do not use abrasive cleaners (such as liquid sand)
and organic solvents not listed above.
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Lumbar support serves for back support to keep the spine in its naturally curved
shape. When the back part is risen (sitting position) the support moreover helps
shorter women in labor to get better to the correct position at the edge of the
seat.
The height of lumbar support is adjusted by repeated pressing (pumping) the
colored spot of the back part (left image) in direction A. Its lowering (deflating)
can be done by pressing the button under the color spot as per left image –
direction B, and simultaneous pressing of the lumbar support.
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Suitability of massaging and its duration is decided by the doctor or the birth
assistant. The massage segment is designed for relaxing massaging of the
back and it is integrated in the back mat of the bed so as to allow normal laying
when the massage function is not in use. It is not a vibrating massage, but a
pressing one with two speeds.
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At the time of reassembly insert carefully the hose coupling in place and tighten
the follower nut.
The delivery mat is fitted by a coupling for synchronizing the potential with other
electrical medical equipment. The coupling is located under the bed of lifting
column. The bed is interconnected to the other device by a cable (not supplied
with the bed), end connector of which is gently connected to the coupling
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10-2012
When changing the bed, always make sure that the upholstery fits
correctly to the seat section of the bed. Spaces filled with fabric do not
fulfil their function. Silicone pins of the upholstery do not hold and there
is a risk of injury of the labouring woman or damage to the plastic parts of
the mattress.
In case of ordering special design of the existing mattress, the back and
seat sections can be equipped with openable zippers to allow better
access to the PUR foam (PPA-370).
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50
Proper
mounting
side
supports
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52
Bochemie
B.Braun Medical
Bode Chemie
ECOLAB
Johnson Diversey
BORCAD Medical a.s. is not responsible for damage to the cushioning (e.g.
cracking, paint flaking etc.), which would result from improper use of
disinfectants. The warranty terminates in such cases.
Before every use, clean and disinfect; always put clean sheets (even
before delivery). Ensure to avoid direct contact of mother body with
upholstery.
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The undercarriage design allows lifting its plastic cover to render easier hygiene
maintenance.
Fig. 1 Fig. 2
Fig. 3 Fig. 4
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Actions to be taken
Description of Actions to be taken
Likely cause by the qualified
problem by the operator
service staff
The remote
Check, if the bed
wireless foot The battery in the
Replace the battery in works with a different
controller is not wireless foot
the remote wireless foot remote wireless foot
working. The controller is
controller. controller. If so,
battery icon is exhausted.
replace it.
flashing orange.
The remote
Check, if the bed
wireless foot
The transmitter is not works with a different
controller is not Pair the transmitter with
paired with the remote foot
working. The the receiver.
receiver. controller. If so,
battery icon is
replace it.
flashing orange.
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The applied parts on the product are classified as Type B - they provide basic
protection of the patient and comply with the applicable requirements of ČSN
EN 60601-1 ed. 2:2007, by which they meet the requirements on classification
of Type B applied parts.
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Packed beds may be exposed for the period of 15 weeks to conditions that do
not exceed the following limits:
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The warranty period for the product is 3 years provided the regular annual
service checks are made.
For all medical equipment produced by the BORCAD Medical a.s. company, the
operator must ensure regular technical safety inspections according to the
producer’s recommendation. The inspections must take place at least 1x per
year or after the carrying out of any repair of the medical equipment or after any
malfunction of the electrical system of the medical equipment. The details about
the scope, parameters and procedures of the technical safety inspection are
specified in the service manual of the medical equipment.
PUR surfaces of the delivery bed (A warranty of 2 years is given for these
parts)
upholstery of the delivery bed (A warranty of 2 years is given for these
parts)
batteries (These are provided with guarantee for 6 months)
The technical service life is 15 years, practical testing results; service life of
battery is limited and must be replaced; gas springs to be replaced every 12
years.
In case the product is not functioning please contact the dealer in your country.
In case of any other disputes, please contact (preferably in English) the
manufacturer at:
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For repairs only use original BORCAD Medical a.s. spare parts and the services
of trained service technicians licensed to repair products of this type.
Unprofessional repairs shall be considered material breach of warranty
conditions and at the same time, in such cases the manufacturer does not bear
any responsibility for any possible damage to the product which might result
from unprofessional intervention.
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BORCAD Medical a.s. is aware of the important role that the protection of our
environment plays for future generations. The materials of this product are
environmentally compatible. It does not contain hazardous substances on the
basis of cadmium, mercury, asbestos, PCB or CFC. The noise emission and the
vibrations meet the directives for premises.
Disposal
Within Europe
When you dispose of your appliance do not put it into the household waste.
Send the appliance to the recycling of electrical appliances.
Outside Europe
Dispose of the bed or its components in accordance with local laws and
regulations:
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