AVE Birthing Bed Instruction Manual

INTRODUCTION ... 3 1 UN-PACKING MANUAL ... 7 2 OVERVIEW OF THE BASIC PARTS OF AVE BIRTHING BED ... 13 2.1 OVERVIEW OF VERSIONS ... 14 2.2 SAFETY ... 14 2.3 SETTING THE PRODUCT ... 20 2.4 OPERATING THE BED... 23 2.4.1 Motor setting (Hand controller) ... 23 2.4.2 Motor setting (Foot controller) ... 24 2.4.3 Motor setting (Wireless foot controller) ... 25 2.4.4 Manual setting of the CPR and Trendelenburg ... 30 2.4.5 Adjusting the foot section ... 31 2.4.6 Adjusting the legrests ... 33 2.4.7 Separable leg supports (PPA-00.46.x) ... 36 2.4.8 Leg holders (joint systém-PPA-00.10-X) ... 38 2.4.9 Adjustment of leg support ... 39 2.4.10 Handle holders for hands for leg rests... 39 2.4.11 Adjusting the tray ... 41 2.4.12 Adjusting the lumbar support (only for version PPA-CX) ... 41 2.4.13 Turning on the massage segment (only for version PPA-BX) ... 42 2.4.14 Equipotential coupling ... 43 2.4.15 Exchangeability of mattresses / upholstery of birth bed bearing surfaces ... 44 3 ACCESSORIES ... 45 3.1 PPA-29-X SUPPORTING UPHOLSTERED BAR... 45 3.2 PPA-33 LARGE STAINLESS STEEL BOWL - 10 L... 45 3.3 PPA-535 UNDERCARRIAGE LIGHT ... 46 3.4 PPA-36 TELESCOPIC INFUSION STAND ... 46 3.5 PPA-48.21 FOOT CONTROLER ... 47 3.6 PPA-556 W IRELESS FOOTCONTROLER ... 47 3.7 PPA-65 PLASTIC BASKET FOR ACCESSORIES ... 48 3.8 PPA-083 BOWL FOR INSTRUMENTS... 48 3.9 PPA-70-X HEAD REST SEMICIRCULAR-ADJUSTABLE ... 49 3.10 PPA-71 HOLDER OF REMOTE CONTROL... 49 3.11 ZK-05.X DOCTOR´S CHAIR ... 49 3.12 GKB-076 DOCTOR´S CHAIR (ERGONOMIC) ... 49 3.13 PPA-00.37 SIDE SUPPORT WITHOUT UPHOLSTERY (PAIR) ... 50 3.14 PPA-00.35-X SIDE SUPPORT WITH UPHOLSTERY (PAIR) ... 50 3.15 PPA-00.36-X DOUBLE SIDE SUPPORT WITH UPHOLSTERY (PAIR) ... 50 4 CARE ... 52 4.1 CLEANING AND DISINFECTION ... 52 5 MAINTENANCE ... 55 5.1 LIST OF ERROR MESSAGES AND OTHER GENERATED MESSAGES ... 55 5.2 TECHNICAL SPECIFICATION... 57 5.3 ELECTRIC PARAMETERS ... 58 5.4 ATTACHED PARTS OF PRODUCT ... 59 5.5 TRANSPORTATION AND STORAGE ... 60 5.6 AMBIENT CONDITIONS FOR OPERATION ... 60 5.7 SERVICE REPAIRS ... 61 5.8 ENVIRONMENT PROTECTION ... 63

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Introduction Please read this complete instruction manual carefully 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 always only in accordance with these instructions. 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. Very important information is marked throughout the manual by the following symbols: Logo

Meaning EU legislation compliant product

Quality management systems certification authority marking

Quality management systems certification authority marking

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

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Pictogram

Meaning Warning

Warning: Dangerous electric voltage This symbol introduces any information, that may help you to avoid operative problems B type accessory part

Serial number

REF int x/y

IP

Type number explanation 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 the ingress of water, hazardous contact and the ingress of foreign objects according to IEC 529 Safe operational load

Safe patient load

Product weight Battery marking Producer Date of production

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Follow the instructions manual

Equipotentiality

Packaging material: “Keep dry” Packaging material: “Fragile!“ 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 about the 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.“ The medical device includes an RF transmitter which emits nonionizing electromagnetic radiation.

Cardiopulmonary resuscitation

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Abbreviation

Meaning

LED

Light emitting diodes

VA

Power intake units

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

ČSN

Protected marking of the Czech technical norms

Hz

Frequency unit in the SI system

EMC VF ME CISPR

Electromagnetic compatibility High frequency Medical equipment International Special Committee on Radio Interference

Any potential queries address please to the authorized representative or directly to the producer BORCAD Medical a.s.

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1 Un-packing manual Carefully cut through prospect and manual pockets and remove them out.

Carefully cut through cover following bottom edge of palette.

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Carefully cut through foil witch hold electrical cable and put into electricity.

Cut through the tape around the box and remove the trapeze.

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Raise the bed back into the position 60 °, the driver is attached to the drawbar engine back under the bed.

Cut the tape on the tray and gradually remove all the accessories.

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Unscrew the medical chair if included.

Remove the box with a bowl if it is included.

All wheels rotate in the direction to the longer end of the palette and lock wheels in the direction.

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Gradually unscrew the screw holding the bed. If is possible try them get down on the floor.

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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Connecting the backup batteries 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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2 Overview of the basic parts of AVE birthing bed

8 9

1 7

2 11 10 6 3

16

4 5

12

14 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 13 BORCAD Medical a.s. 739 45 Fryčovice 673, tel.: +420 558 640 611, fax: +420 558 668 087

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2.1 Overview of versions PPA-AX30 PPA-BX30 PPA-CX30 PPA-AX36

basic type type with massaging segment type with lumbar segment basic type, upholstery with zipper

Color versions of cushioned parts (symbol X): Type P M F B T D3

Color (X): orange corn yellow ocean green brilliant blue pink Pastel orange

The number “36” means special upholstery on request.

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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Delivery bed provides the possibility to perform an acute Caesarean section either under general anaesthesia or NAB anaesthesia (neuraxial block). It also enables for immediate preparation of the birth mother for a Caesarean section and her positioning on the side until the foetus is removed (supine syndrome prevention), also 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 (VF) for making incisions or coagulation. If it is necessary to perform cardiopulmonary resuscitation, it can be performed on this delivery bed including the use of the defibrillator. Delivery bed is also equipped with a Trendelenburg position, which can be operated by both electric drive and mechanically – manually. After 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.  

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 Delivery 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. Based on the supplied equipment it is possible to conduct the delivery in a typical or an alternative way – positions: lying on the back, the semi-recumbent position, on all four limbs, lying on the side, in a squatting position, in a suspended position or squatting down with the help of a partner. In case of acute, urgent or emergency needs it is possible to perform a Caesarean section. 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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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. 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:       

Never use other than original accessories See to correct fixation and setting of accessories (tightening of handles etc.) Do not dismantle and/or interfere with motors, control unit, etc. The AVE bed must not be used in medical facilities with risk of fire or explosion caused by air or in combination with nitrogen oxide and anesthetics or cleaning agents. Structural alternations reserved! The bed must be equipotentially 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 original label containing the name and brand of the manufacturer, designation of the product and a code containing further information (serial number or batch ID and date of manufacture).

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Electrical safety and EMC: 

            



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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 

Portable and mobile 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. 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.

Manual and declaration of the manufacturer - electromagnetic radiation The AVE birthing bed is intended for use in electromagnetic environment specified below. The customer or user of the AVE birthing bed must ensure that the bed is used in such environment. High frequency radiation Group 1 The AVE birthing bed uses high CISPR 11 frequency energy only for its internal functioning. Therefore, its high frequency radiation is very low and is not likely to cause any interference with nearby electronic equipment. High frequency radiation Class A The AVE birthing bed is intended for CISPR 11 use in all facilities other than households and buildings which are Harmonic Not directly connected to a public lowemissions applicable voltage power supply network that IEC 61000-3-2 supplies buildings used for residential Voltage fluctuations/ Not purposes. flicker emissions applicable IEC 61000-3-3

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Mechanical safety:       



 

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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2.3 Setting the product 

      

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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