Borcad AVE 2 User manual

BORCAD Medical a.s., CZ - 739 45 Fryčovice 673
T: [phone], W: www.borcadmedical.com
BIRTHING BED AVE 2
UN-PACKING MANUAL
INSTRUCTION MANUAL
PPB-20170303-EN

2
BORCAD Medical a.s.
739 45 Fryčovice 673, tel.: [phone] www.borcadmedical.com
1 UN-PACKING MANUAL ............................................................................................................................................................................................. 7
2 OVERVIEW OF BASIC PARTS................................................................................................................................................................................ 15
2.1 Overview of basic versions......................................................................................................................... 16
2.2 Overview of standard colour versions......................................................................................................... 16
2.3 Safety.......................................................................................................................................................... 16
2.4 Setting the product...................................................................................................................................... 26
2.4.1 Transport, braking............................................................................................................................... 27
2.4.2 Transportation of the delivery table from one place to another ........................................................... 29
3 OPERATING THE BED............................................................................................................................................................................................. 30
3.1 Side rails..................................................................................................................................................... 30
3.1.1 Description of the control panel for the woman in childbirth................................................................ 30
3.1.2 Lowering procedure ............................................................................................................................ 31
3.1.3 Lifting procedure ................................................................................................................................. 31
3.2 Side control panel....................................................................................................................................... 32
3.3 Manual setting of the CPR.......................................................................................................................... 34
3.4 Electric setting of Trendelenburg................................................................................................................ 35
3.5 Setting of the foot section ........................................................................................................................... 36
3.5.1 Folding/unfolding................................................................................................................................. 37
3.5.2 Lifting/lowering.................................................................................................................................... 38
3.5.3 Tilting up/down.................................................................................................................................... 40
3.6 Adjusting the leg rests................................................................................................................................. 41
3.6.1 Gynaecological position ...................................................................................................................... 42
3.6.2 Foot rest position................................................................................................................................. 43
3.6.3 Maximum bed surface position ........................................................................................................... 46
3.6.4 Turning the leg rests sideways............................................................................................................ 47
3.6.5 Leg rest tray ajdustment...................................................................................................................... 48
3.6.6 Leg rest tray height adjustment........................................................................................................... 49
3.7 Backup Battery ........................................................................................................................................... 50
3.8 Hand grips .................................................................................................................................................. 51
3.9 Tray on the swinging holder........................................................................................................................ 52
3.10 Holder of infusion stand............................................................................................................................ 52
3.11 Head rest.................................................................................................................................................. 53
3.12 Equipotential coupling............................................................................................................................... 53
3.13 Exchangeability of the upholstery ............................................................................................................. 54
4 ACCESSORIES......................................................................................................................................................................................................... 55
4.1 PPB-062 Cable hand controller .................................................................................................................. 55
4.2 PPB-067 Supporting bar............................................................................................................................. 56
4.3 Backlighting of the birthing bed................................................................................................................... 57
4.4 Infusion stand, stainless steel, telescopic................................................................................................... 57
4.5 PPB-064 Eurolath along the seat section ................................................................................................... 57
4.6 PPB-060 Rear bed-head............................................................................................................................. 58
4.7 GKB-076 Doctor's chair (ergonomic).......................................................................................................... 58
4.8 ZK-05.X Doctor’s chair................................................................................................................................ 58
4.9 PPB-069 Front holder with protective elements.......................................................................................... 59
4.10 PPB-070 Upper mattress (for 100 mm cushioning) .................................................................................. 59
4.11 PPB-066 Upper mattress (for 130 mm cushioning) .................................................................................. 59
5 CARE ......................................................................................................................................................................................................................... 60
5.1 Cleaning and disinfection............................................................................................................................ 60
6 MAINTENANCE......................................................................................................................................................................................................... 63
6.1 List of error, malfunction and generated messages.................................................................................... 63
6.2 Technical parameters ................................................................................................................................. 64
6.3 Electrical parameters.................................................................................................................................. 65
6.4 Attached parts of product............................................................................................................................ 65
6.5 Storage instruction...................................................................................................................................... 66
6.6 Ambient conditions for operation ................................................................................................................ 66
6.7 Service and repairs..................................................................................................................................... 66
6.8 Environmental protection and liquidation of the product ............................................................................. 68

3
BORCAD Medical a.s.
739 45 Fryčovice 673, tel.: [phone] www.borcadmedical.com
Introduction
Please read carefully the whole instruction manual, which is designed to familiarize
you with the correct use and the parameters of your new birthing bed. Please
always follow the instructions contained in this manual and use the bed only in
accordance with these instructions.
Please keep these instructions near the bed throughout its operation. Every person
operating the birthing bed AVE 2 must read and understand the contents of these
instructions.
Very important information is marked throughout the manual by the following
symbols:
Pictogram
Meaning
EU legislation compliant product
The upholstery meets the requirements
on resistance to ignition according to BS
7176 in the Medium hazard category.
The upholstery meets the requirements
of BS EN 1021-1, BS EN 1021-2, BS
5852 –resistance to ignition sources 5
Warning:
Dangerous electric voltage
Warning:
Caution
This symbol introduces any information
that may help you avoid operative
problems
Type B applied parts
Serial number

4
BORCAD Medical a.s.
739 45 Fryčovice 673, tel.: [phone] www.borcadmedical.com
REF
Type number explanation
Int x/y
Marking of intermittent operation, i.e. if
the product has been continuously
operated for time period “x”, then it must
rest idle for time period “y”. For example,
int 10 / 20 means that after 10 minutes of
continuous use /positioning the product
must be out of use/not positioned for 20
minutes
IP
Design protection against water ingress,
hazardous contact and the ingress of
foreign objects according to IEC
Safe operational load
Safe patient load
Overall product weight
Battery marking
Producer
Date of production
Follow the instructions manual
Safety isolating transformer
Medical device internal use
Thermal protection of the transformer
Equipotentiality
Packaging material:
“Keep dry”
Packaging material:
“Fragile!“

5
BORCAD Medical a.s.
739 45 Fryčovice 673, tel.: [phone] www.borcadmedical.com
Packaging material:
“This side up”
Temperature limitation
Transportation marking:
„Relative air humidity“.
Transportation marking:
“Air pressure”.
Marking according to the directive EC
2002/96/EC (Directive on disposal of old
electric and electronic appliances).
Symbol for: “Do not dispose of the
product into communal waste. Use
special collection points for old electronic
appliances.“
Cardiopulmonary resuscitation (CPR)
Safe working load of foot section
Warning:
No sitting on leg rest
Safe working load of leg rest
Warning:
Do not push or pull infusion stand
Warning:
Never step on the lifting column cover in
movement. The space is indicated with a
caution sticker.
Warning:
Do not place objects in this area
Warning:
Do not place objects on this cover
Designation of birthing bed for adult

6
BORCAD Medical a.s.
739 45 Fryčovice 673, tel.: [phone] www.borcadmedical.com
Abbreviation
Meaning
LED
Light emitting diodes
VA
Power intake unit
VGA
Computer standard for computer imaging technology
USB
Universal serial bus
LCD
Liquid crystal display
IT
Information technology
PC
Personal computer
dB
Sound intensity unit
hPa
Pressure unit
Hz
Frequency unit in the SI system
EMC
Electromagnetic compatibility
HF
High frequency
ME
Medical equipment
CISPR
International Special Committee on Radio Interference
Please address any potential queries to the authorized representative or directly to
the producer BORCAD Medical a.s.

7
BORCAD Medical a.s.
739 45 Fryčovice 673, tel.: [phone] www.borcadmedical.com
1 UN-PACKING MANUAL
Inspection of the consignment after delivery
Do not unpack and/or accept the consignment if the package has any visual damage!
If so, issue a complaint.
Personal qualification
The persons authorised for installation and putting into operation of the product, i.e.
those trained by BORCAD Medical a.s.
Personnel required for unpacking and installation
Minimum two persons.
Anticipated time
Anticipated time of unpacking is 30 minutes, anticipated time of installation is 30
minutes.
Necessary tools and materials
Set of Allen wrenches, Phillips screwdriver /electric screwdriver, scissors/ knife, blue
Loctite 243, 2x polystyrene ramps are included, wrench 17.
Required working space
When unpacking, overall table dimensions should be considered. Recycle used
packaging materials. We recommend unpacking and installation be made in the
goods receiving department. For unpacking operations, observe minimum 0.8m on
the sides of the pallet and minimum 2.6m in front of the pallet (i.e. minimum space
for unpacking 2.8x5.2m).

8
BORCAD Medical a.s.
739 45 Fryčovice 673, tel.: [phone] www.borcadmedical.com
Sequence of instructions
Cut the pockets with the user guide to the chair open carefully and take them out.
Then remove the box.
Cut the plastic bag open carefully; ideally around the bottom edge of the pallet and
remove the polythene from the chair including the bottom of the box.

9
BORCAD Medical a.s.
739 45 Fryčovice 673, tel.: [phone] www.borcadmedical.com
Cut the foil which holds the power supply cable carefully; plug the cable in. Then cut
the band around the box containing the bed equipment and remove the bar (if
contained in the package). It is recommended to put the back of the bed in an upright
position (60°) in order to access the box easily.
Take out all the equipment from the box item-by-tem.
2x

10
BORCAD Medical a.s.
739 45 Fryčovice 673, tel.: [phone] www.borcadmedical.com
Remove the other container from the pallet, so that the upper part is free.
Unscrew the medical chair (if it is included in the package). It is recommended to put
the bed to a higher position.

11
BORCAD Medical a.s.
739 45 Fryčovice 673, tel.: [phone] www.borcadmedical.com
GO
Remove the bedhead (if it is contained in the package) from the holder and then
unscrew it.
Remove the rest of the packaging material off the bed.
Make sure that all wheels are facing forward alongside the longer part of the pallet
and lock the wheels to move in a straight line.
4x

12
BORCAD Medical a.s.
739 45 Fryčovice 673, tel.: [phone] www.borcadmedical.com
One by one remove the 4 pcs of safety screws; if possible, pull them down to the
floor. The screws are under the wedges the chair is placed on.
Put two polystyrene ramps to the edge of the pallet.
Carefully push the bed so that it gets from the anchoring wedges to the pallet and
then move it down using the ramps.
4x
2x

13
BORCAD Medical a.s.
739 45 Fryčovice 673, tel.: [phone] www.borcadmedical.com
Back-up battery connecting
With regard to the possibility of unwanted switching on of AVE 2 upon packaging,
transport and unpacking, the battery is normally disconnected from the equipment.
The following pictures show how to connect the battery.
Remove the undercarriage cover.
The cover is removed by screwing out three wrenches.
Insert the connector in the back-up battery.

14
BORCAD Medical a.s.
739 45 Fryčovice 673, tel.: [phone] www.borcadmedical.com
Put the protective cover in place and screw the Allen wrenches back on. Put the
undercarriage cover back in place.
Fitting of leg rest
Insert the leg rest in the joint. Hold the controller and insert the lock pin with the other
hand.
Release the leg rest controller and secure the pin with a protective cap. Screw the
cap with two Allen wrenches with blue Loctite.

15
BORCAD Medical a.s.
739 45 Fryčovice 673, tel.: [phone] www.borcadmedical.com
2 Overview of basic parts
1. back section
2. seat section
3. foot section
4. castor, directional 1x
5. castor with brake 3x
6. plastic covers of chassis
7. leg rests
8. headrest
9. back handle for transportation
10. eurolath along seat section (accessories)
11. tray on swinging holder
12. side control panel
13. control light for power supply
14. holder for infusion stand
15. hand grips
16. side rails with electric control panel
17. central brake
18. manual CPR functions
19. leg rest tray
20. detachable bed-head (accessories)
6
14
9
5
4
8
3
2
11
1
7
15
17
16
19
20
10
12
13
18

16
BORCAD Medical a.s.
739 45 Fryčovice 673, tel.: [phone] www.borcadmedical.com
2.1 Overview of basic versions
PPB-AX
basic type
2.2 Overview of standard colour versions
Substituted by the letter “X”.
A –Purple
M –Corn Yellow
B –Brilliant Blue
P - Orange
F –Ocean Green
T - Pink
2.3 Safety
Standards
The product meets the requirements of valid standards EN 60 601-1 ed. 3 and IEC
60 601-1-2 ed. 2. According to the current text of the Directive on Medical
Instrumentation 93/42/EEC, the birthing bed is classified as medical device of 1st
class, non-sterile, without measuring function.
The bed complies with the following standards and directives:
EN 60601-2-52
EN ISO 60601-1
EN ISO 60601-1-2
EN ISO 60601-1-6
EN ISO 13485
EN ISO 14971
93/42/EEC
2011/65/EU

17
BORCAD Medical a.s.
739 45 Fryčovice 673, tel.: [phone] www.borcadmedical.com
Function
Warning:
Caution
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 achieve their optimum
position for birth. Positioning and handling the bed is not an obstacle in providing
healthcare. Handling the foot section, especially by folding it (fast way to store it
under the seat/back section) at the end of the second stage of delivery creates
enough space to perform obstetrical and vaginal surgeries. It is also useful for
practical training of medical students and midwives. It also enables positioning on the
side until the foetus is removed (supine syndrome prevention), as well as the use of
other medical devices (resulting in ME system) for continuous control of reduced
venous return, blood pressure, routine ECG monitoring, pulse oximeter, NIBP, and
capnometry. During procedures it is possible to use approved surgical devices (HF)
for making incisions or coagulation. If it is necessary to perform cardiopulmonary
resuscitation, it can be performed in this delivery bed including the use of the
defibrillator. Delivery bed is also equipped with a Trendelenburg position. After the
delivery and the transfer of a birth mother it is necessary to wash and disinfect all
the easily removable parts and light upholstery together with plastic parts and covers
again.

18
BORCAD Medical a.s.
739 45 Fryčovice 673, tel.: [phone] www.borcadmedical.com
Indication
Birthing bed is designated to be used by mothers ready for spontaneous vaginal
delivery and also as aid to search for individual positions providing relief in all
delivery stages including postpartum period. Birthing bed is not intended for use as a
general hospital bed.
Contra-indications
Absolute contra-indication is the use of the delivery bed for elective (planned)
Caesarean sections when it is possible 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 AVE 2.
General instructions
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.
Application environment 5
Outpatient (ambulatory) care, which is provided in a hospital or other medical facility,
under medical supervision and me equipment, is provided for the need of persons
with illness, injury or disability for treatment, diagnosis or monitoring.

19
BORCAD Medical a.s.
739 45 Fryčovice 673, tel.: [phone] www.borcadmedical.com
General safety:
Warning:
Caution
Birthing Bed is not primarily intended for newborns. For this case there is a special
cot which comes as a separate medical device. It is assumed that the position of the
baby during breast-feeding is under the constant control of the mother and thus any
uncontrollable movement of a newborn on the bed is improbable. After breastfeeding
the newborn baby is moved into the cot intended for this purpose. The caregivers
are informed about potential risks in the instruction manual.
Do not operate the table in rooms with inflammable gases/vapours. Danger of
injury/damage of the equipment.
Use only ventilation or nasal-type oxygen supply units. Do not use the table in
oxygen tents (risk of injury or damage of the equiment).
Make sure to fix and set the accessories properly (tightening of handles etc.)
Do not dismantle or execute unqualified repairs of motors, control unit, etc.
The AVE 2 bed must not be used in medical facilities with fire or explosion
risks caused by air or in combination with nitrous oxide and anesthetics or
cleaning agents.
Construction modifications reserved!
The bed must be equipotentialy connected with other medical devices to prevent
fire in combination with flammable substances and anesthetics during minor
surgical procedures using high-frequency (HF) instruments.
Never use other than original accessories. All original accessories are marked
with an original label containing the name and brand of the manufacturer,
designation of the product and a code including further information (serial
number or batch ID and date of manufacture).
Leave the bed in a low position when the patient is unattended. This can reduce
the possibility of the patient falling down and the severity of any resultant injuries.

20
BORCAD Medical a.s.
739 45 Fryčovice 673, tel.: [phone] www.borcadmedical.com
Electrical safety and EMC:
Warning:
Dangerous electric voltage
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.
To avoid risk of electric shock, this chair must be connected to power main with
protective earthing.
The bed must be positioned in such a way so that it could be immediately
disconnected from the power main if necessary.
Modifications to the birthing bed are forbidden.
If there is a fluctuation in the voltage range, then it is necessary to connect the
product to voltage regulator. Otherwise the electronics can be damaged!
The birthing bed is intended only for use by medical professionals.
The birthing bed may cause radio interference, which can affect function of nearby
device. It may be necessary to take measures to reduce these effects, such as
redirection, relocation or shielding of the device.
Portable mobile and HF communication devices should not be used closer than the
recommended distance of d = 15 cm from any part of the birthing bed, including the
cables.
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
LED indicator on the side control panel of the bed.
Power cable of the bed must not be connected through an extension cord.
Only connection possible is directly in the power socket.
Avoid hanging the power cable over moving parts of the bed. When back up
batteries are in use, the cable may be damaged!
No input cable can lead over the bed and nor over the patient.
Within the radius of 1.50 m, within the patient space, only medical equipment
meeting standard EN 60601-1 may be used.
Birthing bed is not intended for use in areas enriched with oxygen, i.e. more than
25% or partial oxygen pressure 27,5 kPa.
The birthing bed must be installed and put into operation in compliance with
information related to EMC provided in the accompanying documentation.
Portable and mobile HF communication devices may influence the electrical
medical device.