BORCAD Medical
AVE 2 Birthing Bed Instruction Manual Ver 06 Nov 2020
Instruction Manual
93 Pages

Preview
Page 1
BIRTHING BED AVE2 UN-PACKING MANUAL INSTRUCTION MANUAL
D9U004PPB-0101 Version: 06 Punlication Date: 2020-11
BORCAD Medical a.s., CZ - 739 45 Fryčovice 673 T: +420 558 640 631, W: 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 2 BORCAD Medical a.s. 739 45 Fryčovice 673, tel.: +420 558 640 631
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
3 BORCAD Medical a.s. 739 45 Fryčovice 673, tel.: +420 558 640 631
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
IP
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 Design protection against water ingress, 4
BORCAD Medical a.s. 739 45 Fryčovice 673, tel.: +420 558 640 631
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”. 5 BORCAD Medical a.s. 739 45 Fryčovice 673, tel.: +420 558 640 631
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
6 BORCAD Medical a.s. 739 45 Fryčovice 673, tel.: +420 558 640 631
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!
7 BORCAD Medical a.s. 739 45 Fryčovice 673, tel.: +420 558 640 631
www.borcadmedical.com
Abbreviation LED VA IT PC dB hPa Hz EMC HF ME CISPR
Meaning Light emitting diodes Power intake unit Information technology Personal computer Sound intensity unit Pressure unit Frequency unit in the SI system Electromagnetic compatibility High frequency Medical equipment 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 underfoot part is neither in the the Trendelenburg button. 'parked' nor in the 'active' position. Intermittent acoustic signal when pressing The battery charge is lower than the positioning button. 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.
8 BORCAD Medical a.s. 739 45 Fryčovice 673, tel.: +420 558 640 631
www.borcadmedical.com
Production label – explanation of symbols:
1
4
2
5 1 2 3 4 5 6 7 8 9
6
3
7
8
9
Address of Manufacturer Type of product, serial number Manufacturing Date (Year-Month-Day) DI (Device Identifier)/ GTIN (Global Trade Item Number) PI (Product Identifier) 2D Bar Code (GS1 DataMatrix) DI+PI=UDI Electrical Specification 1D Bar code GS1-128 (Serial number) Symbols
Please address any potential queries to the authorized representative or directly to the Manufacturer BORCAD Medical a.s. 9 BORCAD Medical a.s. 739 45 Fryčovice 673, tel.: +420 558 640 631
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).
10 BORCAD Medical a.s. 739 45 Fryčovice 673, tel.: +420 558 640 631
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.
11 BORCAD Medical a.s. 739 45 Fryčovice 673, tel.: +420 558 640 631
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
12 BORCAD Medical a.s. 739 45 Fryčovice 673, tel.: +420 558 640 631
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.
13 BORCAD Medical a.s. 739 45 Fryčovice 673, tel.: +420 558 640 631
www.borcadmedical.com
Remove the bedhead (if it is contained in the package) from the holder and then unscrew it.
4x
Cut off and pull out the tape, release foot section
Remove plastic plug from the locking element.
14 BORCAD Medical a.s. 739 45 Fryčovice 673, tel.: +420 558 640 631
www.borcadmedical.com
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. GO
15 BORCAD Medical a.s. 739 45 Fryčovice 673, tel.: +420 558 640 631
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.
4x Put two polystyrene ramps to the edge of the pallet.
2x Carefully push the bed so that it gets from the anchoring wedges to the pallet and then move it down using the ramps.
16 BORCAD Medical a.s. 739 45 Fryčovice 673, tel.: +420 558 640 631
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.
17 BORCAD Medical a.s. 739 45 Fryčovice 673, tel.: +420 558 640 631
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.
18 BORCAD Medical a.s. 739 45 Fryčovice 673, tel.: +420 558 640 631
www.borcadmedical.com
2 Overview of basic parts 20 1
8 9 13
16 2
15
12 18
7 10 19 11 14
3
5 17 6 4 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)
19 BORCAD Medical a.s. 739 45 Fryčovice 673, tel.: +420 558 640 631
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 B – Blue F – Green
M – Yellow P - Orange
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 Powder extinguisher CO2 extinguisher Halotron extinguisher
Do not use Foam extinguisher Water extinguisher
20 BORCAD Medical a.s. 739 45 Fryčovice 673, tel.: +420 558 640 631
www.borcadmedical.com