BORCAD Medical AVE 2 User manual

BORCAD Medical a.s., CZ - 739 45 Fryčovice 673
T: [phone], W: www.borcadmedical.com
BIRTHING BED AVE2
UN-PACKING MANUAL
INSTRUCTION MANUAL
D9U004PPB-0101
Version: 06
Punlication Date: 2020-11

2
BORCAD Medical a.s.
739 45 Fryčovice 673, tel.: [phone] www.borcadmedical.com
1 UN-PACKING MANUAL............................................................................................................................... 10
2 OVERVIEW OF BASIC PARTS ................................................................................................................... 19
2.1 Overview of basic versions ............................................................................. 20
2.2 Overview of standard colour versions............................................................. 20
2.3 Safety.............................................................................................................. 20
3 FUNCTION ...................................................................................................................................................... 21
3.1 Interaction....................................................................................................... 21
3.2 General instructions........................................................................................ 21
3.3 Application environment 5............................................................................... 21
4 INTENDED USE.............................................................................................................................................. 22
4.1 User population............................................................................................... 22
4.2 Contraindications ............................................................................................ 22
4.3 Operator.......................................................................................................... 22
5 GENERAL SAFETY....................................................................................................................................... 23
5.1 Electromagnetic compatibility.......................................................................... 24
5.2 Mechanical safety........................................................................................... 27
6 SETTING THE PRODUCT............................................................................................................................ 28
6.1 Transport, braking ....................................................................................... 29
6.2.Transport..................................................................................................... 31
7 OPERATING THE BED................................................................................................................................. 33
7.1 Side rails......................................................................................................... 33
7.1.1 Description of the control panel for the woman in childbirth ..................... 33
7.1.2 Adjustment of the handle in inactive position............................................ 34
7.1.3 Adjustment of the handle in active position .............................................. 34
7.2 Side control panel ........................................................................................... 35
7.3 Manual setting of the CPR.............................................................................. 37
7.4 Electric setting of Trendelenburg .................................................................... 38
7.5 Setting of the foot section................................................................................ 39
7.5.1 Folding/unfolding...................................................................................... 39
7.5.2 Lifting/lowering.......................................................................................... 41
7.5.3 Tilting up/down ......................................................................................... 43
7.6 Adjusting the leg rests..................................................................................... 44
7.6.1 Gynaecological position............................................................................ 45
7.6.2 Foot rest position...................................................................................... 46
7.6.3 Maximum bed surface position................................................................. 49
7.6.4 Turning the leg rests sideways................................................................. 50
7.6.5 Leg rest tray ajdustment........................................................................... 51
7.6.6 Leg rest tray height adjustment ................................................................ 52
7.6.7 Leg straps................................................................................................. 53
7.7 Backup Battery................................................................................................ 54
7.8 PPB-068 Grab handles, detachable (R/L)....................................................... 55
7.9 PPB-013 Grab handles, non-detachable, foldable (R/L)................................. 55
7.10 Holder of infusion stand ................................................................................ 57
7.11 Equipotential coupling................................................................................... 57

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BORCAD Medical a.s.
739 45 Fryčovice 673, tel.: [phone] www.borcadmedical.com
7.12 Exchangeability of the upholstery ................................................................. 58
8 ACCESSORIES ............................................................................................................................................... 59
8.1 PPB-062 Cable hand controller....................................................................... 59
8.2 PPB-071 Supporting bar................................................................................. 60
8.3 Under carriage light......................................................................................... 60
8.4 SB-B-00322 Infusion stand, stainless steel, telescopic................................... 61
8.5 PPB-064 Eurolath along the seat section........................................................ 61
8.6 PPB-060 Rear bed-head................................................................................. 62
8.7 GKB-076 Doctor's chair (ergonomic) .............................................................. 62
8.8 ZK-05.X Doctor’s chair.................................................................................... 62
8.9 PPB-069 Front bumper on foot section........................................................... 63
8.10 PPB –066.01 Upper mattress (for 100 mm cushioning)............................... 63
8.11 PPB –070.01 Upper mattress (for 130 mm cushioning)............................... 63
8.12 PPA-010 Tray on the swinging holder........................................................... 64
8.13 Nurse call...................................................................................................... 65
8.14 PPB-077 Front bumper fitted on the leg rest (R/L)........................................ 66
8.15 Head rest ...................................................................................................... 66
8.16 Bowl PPB-034............................................................................................... 67
8.17 DB-B-00194 Instrument tray ......................................................................... 67
8.18 PPB-088 Protractor of the seat part, PPB-098 Protractor of the back part.... 68
8.19 PPB-097 Bracket for oxygen bottles ............................................................. 69
8.20 S4-04642A Patient card................................................................................ 70
8.21 Baby plate..................................................................................................... 71
PPB-074 Version with mattress ............................................................................ 72
9 CARE................................................................................................................................................................ 75
9.1 Cleaning and disinfection................................................................................ 75
9.1.1 Cleaning the bed ...................................................................................... 76
9.1.2 Recommended disinfection (disinfectants for wiping)............................... 78
9.1.3 How to properly coat bed with hospital bedding ....................................... 79
9.1.4 How to properly coat bed with Disposable bed sheets............................. 80
9.1.5 How to properly coat bed with terrycloth................................................... 81
10 MAINTENANCE........................................................................................................................................... 82
10.1 List of error, malfunction and generated messages ...................................... 83
10.2 Technical parameters.................................................................................... 84
10.3 Electrical parameters .................................................................................... 85
10.4 Attached parts of product.............................................................................. 86
10.5 Transport instruction, Storage instruction...................................................... 87
10.6 Service and repairs....................................................................................... 88
11 ENVIRONMENTAL PROTECTION AND LIQUIDATION OF THE PRODUCT............................... 89
12 LIST OF AVAILABLE EQUIPMENT........................................................................................................ 90

4
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 AVE2 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
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,

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BORCAD Medical a.s.
739 45 Fryčovice 673, tel.: [phone] www.borcadmedical.com
hazardous contact and the ingress of
foreign objects according to IEC 529
Safe working load
Maximum patient weight
Overall product weight
Battery marking
Manufacturer
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!“
Packaging material:
“This side up”
Temperature limitation
Transportation marking:
„Relative air humidity“.
Transportation marking:
“Air pressure”.

6
BORCAD Medical a.s.
739 45 Fryčovice 673, tel.: [phone] www.borcadmedical.com
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. “
Terry cloth sheet
The product must not be ironed
Terry cloth sheet
Do not dry clean
Terry cloth sheet
Maximum temperature of 60°C
Normal setting
Terry cloth sheet
Do not bleach
Terry cloth sheet
May be tumble dried
Normal temperature, max. 80 ° C
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

7
BORCAD Medical a.s.
739 45 Fryčovice 673, tel.: [phone] www.borcadmedical.com
MEDICAL DEVICE
(compatible with Medical Device Regulation)
UNIQUE DEVICE IDENTIFIER
Caution or Warning:
The power cable shall always be
clamped on the selected place of the bed
using a plastic hook as is recommended
on picture!
Follow the instructions manual!

8
BORCAD Medical a.s.
739 45 Fryčovice 673, tel.: [phone] www.borcadmedical.com
Abbreviation
Meaning
LED
Light emitting diodes
VA
Power intake unit
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
SWL
Working load limit
Acoustic signalling
Sound
Meaning
One short acoustic signal when pressing
the button.
Key lock activated
Intermittent acoustic signal when pressing
the Trendelenburg button.
The underfoot part is neither in the
'parked' nor in the 'active' position.
Intermittent acoustic signal when pressing
the positioning button.
The battery charge is lower than
1/3 of its capacity.
Intermittent acoustic signal when pressing
the positioning button.
Motor current protection activated.
Intermittent acoustic signal even without
pressing any button.
Failure of the controller.
Continuous sound when simultaneously
pressing the up and down column buttons.
Motor current protection resetting.

9
BORCAD Medical a.s.
739 45 Fryčovice 673, tel.: [phone] www.borcadmedical.com
Production label –explanation of symbols:
1
Address of Manufacturer
2
Type of product, serial number
3
Manufacturing Date (Year-Month-Day)
4
DI (Device Identifier)/ GTIN (Global Trade Item Number)
5
PI (Product Identifier)
6
2D Bar Code (GS1 DataMatrix) DI+PI=UDI
7
Electrical Specification
8
1D Bar code GS1-128 (Serial number)
9
Symbols
Please address any potential queries to the authorized representative or directly to
the Manufacturer BORCAD Medical a.s.
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5
7
6
3
2
8
9
1

10
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 bed 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).

11
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 bed 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.

12
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

13
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.

14
BORCAD Medical a.s.
739 45 Fryčovice 673, tel.: [phone] www.borcadmedical.com
Remove the bedhead (if it is contained in the package) from the holder and then
unscrew it.
Cut off and pull out the tape, release foot section
Remove plastic plug from the locking element.
4x

15
BORCAD Medical a.s.
739 45 Fryčovice 673, tel.: [phone] www.borcadmedical.com
GO
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.

16
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

17
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 AVE2 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.

18
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.

19
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 with leg straps
8. headrest
9. back handle for transportation
10. eurolath along seat section (accessories)
11. tray on swinging holder (accessories)
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

20
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 –Yellow
B –Blue
P - Orange
F –Green
2.3 Safety
Standards and specifications
Referenced standards are listed in the Declaration of Conformity.
The manufacturer has implemented certified quality management system in
accordance with the following standards:
•ISO 9001
•ISO 14001
•ISO 13485
Fire Extinguishing Information
Warning:
Note
Danger of frostbite by contact of CO2 with human skin!
Do not use halotron extinguisher in closed rooms without ventilation –danger to your
health!
The medical product is categorised as energised electric installation, hence, fire can
be extinguished by the following types of extinguishers.
Use
Do not use
Powder extinguisher
Foam extinguisher
CO2 extinguisher
Water extinguisher
Halotron extinguisher