BORCAD Medical AVE 2 Instruction Manual Download Page 26

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BORCAD Medical a.s.

739 45 Fryčovice 673, tel.: +420 558 640 631

www.borcadmedical.com

Table 1

– IMMUNITY to RF wireless communications equipment

Test

frequency

(MHz)

Band

(MHz)

Service

Modulation

Immunity

test level

V/m

385

380 - 390

TETRA 400

Pulse

modulation 18

450

430 - 470

GMRS 460, FRS 460

FM ± 5 kHz

deviation 1

kHz sine

710
745
780

704 - 787

LTE band 13, 17

Pulse

modulation

217 Hz

810
870
930

800 - 960

GSM 800/900, TETRA
800, iDEN 820, CDMA

850,

LTE band 5

Pulse

modulation 18

1 720
1 845
1 970

1 700 - 1

990

GSM 1800; CDMA 1900;

GSM 1900; DECT; LTE

band 1, 3, 4, 25; UMTS

Pulse

modulation

217 Hz

2 450

2 400 - 2

570

Bluetooth, WLAN, 802.11

b/g/n, RFID 2450,

LTE band 7

Pulse

modulation

217 Hz

5 240
5 500
5 785

5 100 - 5

800

WLAN 802.11 a/n

Pulse

modulation

217 Hz

NOTE

There are applied no deviations to requirements of IEC 60601-1-2 ed. 4

NOTE

There are no known other measures for keeping the basic safety based on

EMC phenomena.

Summary of Contents for AVE 2

Page 1: ...BORCAD Medical a s CZ 739 45 Fry ovice 673 T 420 558 640 631 W www borcadmedical com BIRTHING BED AVE2 UN PACKING MANUAL INSTRUCTION MANUAL D9U004PPB 0101 Version 06 Punlication Date 2020 11...

Page 2: ...e 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...

Page 3: ...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...

Page 4: ...lowing 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 meet...

Page 5: ...rall product weight Battery marking Manufacturer Date of production Follow the instructions manual Safety isolating transformer Medical device internal use Thermal protection of the transformer Equipo...

Page 6: ...heet 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 res...

Page 7: ...cadmedical 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 pla...

Page 8: ...ling 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...

Page 9: ...l 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 cod...

Page 10: ...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 screwdrive...

Page 11: ...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 th...

Page 12: ...ower 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...

Page 13: ...ce 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...

Page 14: ...ce 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 Cut off and pull out the tape release foot section Remove plas...

Page 15: ...e 673 tel 420 558 640 631 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 t...

Page 16: ...ve 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...

Page 17: ...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...

Page 18: ...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...

Page 19: ...g 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 s...

Page 20: ...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...

Page 21: ...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 i...

Page 22: ...egivers and hospital staff midwives labor and delivery nurses doctors and technical personnel transport personnel cleaning personnel interns and birth professional students Maintenance personnel 4 2 C...

Page 23: ...s medical device is not intended for use with flammable substances This medical device is not portable medical electrical equipment Make sure the duty cycle 2 min ON 18 min OFF is not exceeded during...

Page 24: ...cturer instructions electromagnetic emissions WARNING It is recommended to avoid the use of this device next to or in block with other device because it could lead to improper operation If such use is...

Page 25: ...iated RF IEC 61000 4 3 Proximity fields from RF wireless communications equipment IEC 61000 4 3 3 V m 80 MHz 2 7 GHz 80 AM at 1 kHz See Table 1 Fast electrical transients burst IEC 61000 4 4 2 kV for...

Page 26: ...modulation 217 Hz 9 810 870 930 800 960 GSM 800 900 TETRA 800 iDEN 820 CDMA 850 LTE band 5 Pulse modulation 18 Hz 28 1 720 1 845 1 970 1 700 1 990 GSM 1800 CDMA 1900 GSM 1900 DECT LTE band 1 3 4 25 U...

Page 27: ...ccessing the bed only from side of seat section The bed is not designed for mothers over 240 kg 527 lb No objects that may collide with the bed furniture stands etc may be located near it Never enter...

Page 28: ...g kinking of any objects Pay attention to proper fixing of the approved accessories listed in the manual The birthing bed is installed by trained person It can be operated in ordinary way by trained p...

Page 29: ...cables including the power supply cable hoses tubes etc are safely placed in the area bounded by the circumference of the bed Otherwise you can cause injury to persons or damage to the device During...

Page 30: ...n transporting the bed by one operator activate the direction castor otherwise the transport must be carried out by two operators 6 During transport interruption central brake must always be applied 7...

Page 31: ...he cable Always call technical service operator Only rear handles can be used for transporting the bed Do not transport any patient when the bed is in chair position Danger of injury to the patient or...

Page 32: ...distance check the castor control is active main control lever Release the brake before transporting the bed The delivery bed is fitted with four castors 150 mm on default and it may be moved in all d...

Page 33: ...orised software tool and by check of compatibility of the new firmware with the bed Components of the product are not treated against fire Hence avoid handling near open fire If this rule is not obser...

Page 34: ...for better access to the patient during birth 7 1 3 Adjustment of the handle in active position In the active position you only need to pull the handle to the highest position The rail locks in the a...

Page 35: ...ol panel is located on both sides of AVE2 birthing bed The panel can be operated by trained personnel only Locking of the bed control You activate the control lock with pressing the button when the di...

Page 36: ...39 45 Fry ovice 673 tel 420 558 640 631 www borcadmedical com Lowering lifting of the seat section Bed height adjustment Lowering lifting of the back section CPR lever Battery status indicator Indicat...

Page 37: ...ith CPR text During movement the back support must be loaded e g with the patient s weight To activate the function use one hand to push the red lever in the specified direction Use your other hand to...

Page 38: ...itioning movement and the control box generates a sound signal the foot section has not been fixed properly During movement the back support must be loaded e g with the patient s weight For positionin...

Page 39: ...g maximum 330 lb The load capacity of foot section and leg rests together is 170 kg maximum 374 lb Do not overload the footrest due to the unsecured positon It is necessary to always secure the part i...

Page 40: ...45 Fry ovice 673 tel 420 558 640 631 www borcadmedical com 7 5 1 Folding unfolding In lowered position the foot section can be folded and locked in two positions a Folded the part is hidden under the...

Page 41: ...burg position In case of putting aside the upholstery of the foot section from the bed it must be placed on its wide laying surface on flat surface such as ground or bed In case of lying the foot sect...

Page 42: ...e grab the front edge of the foot section and pull upwards to the desired position Releasing the control lever locks the selected position Lowering Pull the control lever with the right hand and at th...

Page 43: ...edical com 7 5 3 Tilting up down Pull the control lever with the right hand Then push the foot section downwards You can lock the foot section in any position by releasing the control lever Uninterrup...

Page 44: ...e transport This means to set up the lowest height level and turn them in a way that their edges do not overlap the edges of the footrests Manipulation with the foot section or seating section and wit...

Page 45: ...vice 673 tel 420 558 640 631 www borcadmedical com 7 6 1 Gynaecological position For positioning pull Turning the leg rest sideways control lever as on the picture below and with the same hand pull th...

Page 46: ...same hand pull the leg rest in the desired position Then adjust the leg rest tray With one hand pull the Folding unfolding of the leg rest tray control lever as on the picture below Then with same ha...

Page 47: ...631 www borcadmedical com 7 6 2 Foot rest position The leg rests can be adjusted in the Foot rest position For positioning pull Turning the leg rest sideways control lever as on the picture below and...

Page 48: ...edical a s 739 45 Fry ovice 673 tel 420 558 640 631 www borcadmedical com Then pull the Tilting of the leg rest control lever as on the picture below and with same hand pull the leg rest in the desire...

Page 49: ...unction one laying surface can be achieved together with the seat and back sections For positioning pull Turning the leg rest sideways control lever as on the picture below and with the same hand posi...

Page 50: ...he leg rests can be turned sideways for better access to a birth mother For turning the leg rest sideways pull the control lever as on the picture below Then pull the leg rest to the desired position...

Page 51: ...e physical proportions of the birth mother To do so the leg rest must be in Gynaecological position Then with one hand pull the control lever as on the picture below Then with the same hand adjust the...

Page 52: ...e physical proportions of the birth mother To do so the leg rest must be in Gynaecological position Then with one hand pull the control lever as on the picture below With the other hand adjust the leg...

Page 53: ...6 7 Leg straps Fixing straps for legs are integral part of each foot rest to enable better support of flaccid muscles of the mother to be during the stages of birth Loosen the strap 1 place the mothe...

Page 54: ...necessary time for charging will take at least 24 hours The fully charged back up battery will last in the stand by mode for approxi mately 1 to 2 months at the optimum temperature of 15 to 25 C The a...

Page 55: ...of the personnel and or the mother in labor when adjusting the leg rests The handles can be attached only in the position showed below it is forbidden to fix them with the rubberized hold downwards Th...

Page 56: ...the personnel and or the mother in labor when adjusting the leg rests The optional grab handles at extra costs are designed as the non detachable ones These handles provide for parking and active pos...

Page 57: ...nfusion stand 7 11 Equipotential coupling The delivery bed is fitted with a coupling for synchronizing the potential with other electrical medical equipment The coupling is located behind the bed unde...

Page 58: ...tery and as such pose a risk of injury of the labouring woman or damage to the plastic parts of the mattress The birth bed is fitted with replaceable upholstery In case of damage to the upholstery e g...

Page 59: ...r may use the hand controller buttons to set the height position of the seat and back section inclination The functions of the control buttons are shown in the picture below Motoric setting is done by...

Page 60: ...porting bar Warning Caution Maximum weight load of the supporting bar is 70 kg in all direction 154 lb Supporting bar is vertically locked up it may be ejected from the holder in the upward direction...

Page 61: ...pacity of one hook 2 kg Infusion stand is only used to hold infusion It is restricted to use it for manipulation with birthing bed It is also necessary to be cautious when manipulating with the bed in...

Page 62: ...not intended for the suspension of a woman in labour by means of an auxiliary rope bed sheet or a towel Rear bed head represents a safety element of the bed and can be used by the birth mother as a h...

Page 63: ...tached to the holder and it serves as foot section protection as well The set contains two side bumpers 8 10 PPB 066 01 Upper mattress for 100 mm cushioning The accessory is primarily used after post...

Page 64: ...holder Warning Caution Tray may only be manipulated when the lying section of the foot rest section is adjusted in the low position The stainless steel tray is foldable on the swinging holder forth a...

Page 65: ...out 1 or 2 months if the bed positioning is not used The nurse call button is located on the inner side of the side handle control panel on the side of the labouring woman After pressing and releasing...

Page 66: ...contour of the leg rest Intended for hanging the accessories and at the same time leg rest protection 8 15 Head rest Comfort head rest can support the head of the woman in childbirth Thanks to its erg...

Page 67: ...be shifted below the seat section after giving birth it is always recommended to remove it and park only the bowl holder 8 17 DB B 00194 Instrument tray This flat stainless stell tray is in most case...

Page 68: ...640 631 www borcadmedical com 8 18 PPB 088 Protractor of the seat part PPB 098 Protractor of the back part Caution Warning The protractor is only for information It is used to inform about the inclin...

Page 69: ...actively using the oxygen bottle holder always check the correct dimensions of the oxygen cylinder including the top of the bottle Larger dimensions can collide with positioning bars When positioning...

Page 70: ...Snap only to the front bumper on the leg rest If the patient s card is hung in other places such as the bed side or the headboard there is a risk of instability These parts of the bed are mobile Ther...

Page 71: ...rt of the new born When installing the new born on the baby plate always do it on the longest part of the mattress The installation of the new born on the shorter part of the mattress may fall to the...

Page 72: ...time The umbilical cord is cut when the new born is placed on the baby plate and then placed on the breast of his mother or on another table to perform some necessary procedures Then it can be used t...

Page 73: ...When mounting the baby plate on the delivery bed the locking levers must be moved to the unlocked position in the direction of the green arrow Then slide the baby plate by the handles in the seat par...

Page 74: ...late from the delivery bed Remove the baby plate in the reverse order of installation When removing the baby plate from the delivery bed the locking levers must be moved to the unlocked position in th...

Page 75: ...ased solvents By using too much cleaner you risk water leakage into the motor parts of the product which may damage the electric wiring and render the product not functional In case of improperly perf...

Page 76: ...f the delivery bed seat back foot part and footrests 9 1 1 Cleaning the bed 1 Supporting area including the head pillow starting from the head section toward the lower section 2 Hangers and hand grips...

Page 77: ...left cover you can lift the right plastic cover as well and clean the chassis Make sure not to interfere with the electronics After cleaning first fit the right cover then the left cover 11 Infusion s...

Page 78: ...wipes QAS Wipe Sani cloth active Hydrogen Peroxide Wipe Incidin OxyWipe S Amine Alcohol up to 30 Wipe Bacillol 30 tissues Concentrated disinfectants to be diluted Active substance Concentration of the...

Page 79: ...m the operating room the size of which corresponds to that of the relevant delivery bed section or with a fabric coating used for standard beds First of all the lying section back section or seat sect...

Page 80: ...ly for AVE2 birthing bed can also be used Swing out the back section of the mattress and put the coating on it Then return the back section to its place lift the seat section and put the coating on it...

Page 81: ...oat bed with terrycloth You can also use special shape terrycloth set directly onto AVE2 birthing bed Swing out the seat section of the mattress and put the coating on it Return the seat section to it...

Page 82: ...need to be replaced every 12 years the upholstery is guaranteed for 2 years Treads of fastening screws or the joins on the frame parts may get degreased by disinfectants In these cases timely lubrica...

Page 83: ...ns are not working The hand controller cable is not properly inserted in the bed connector Make sure the hand controller cable is inserted properly in the bed connector Check if the bed responds with...

Page 84: ...inch Back section 100 130mm 3 93 5 11 inch Seat section 100 130mm 3 93 5 11 inch Adjustment angles Back section positioning angle 10 70 Seat section positioning angle 0 18 5 Trendelenburg position 10...

Page 85: ...n the control unit 220 240V T 3 15 AL 250V Nominal value of the fuse in the control unit 100V T 6 3AL 250V Nominal value of the fuse in the control unit 110 120V T 6 3AL 250V Nominal value of the fuse...

Page 86: ...ng the back section seat section and for bed height adjustment These motors require no maintenance 10 4 Attached parts of product The attached parts on the product are classified as Type B they provid...

Page 87: ...com 10 5 Transport instruction Storage instruction Packed birthing beds may be exposed to conditions not exceeding the following limits for the period of up to 15 weeks Operation 10 C 40 C 30 75 795 h...

Page 88: ...t take place at least 1x per year or after the carrying out of any repair of the medical equipment or after any intervention regarding the electrical system of the medical equipment The details about...

Page 89: ...ponding pictograms and disposes of it by means of an authorized waste material disposing entity For the free of charge waste material take back please contact BORCAD Medical a s sales representative o...

Page 90: ...ectric cable JAR spiral 4m orange PPB 050 30 Electric wire IZR straight 3 5m orange PPB 050 31 Electric cable EU spiral 4m orange PPB 050 32 Electric cable USA straight 4m orange PPB 050 33 Electric w...

Page 91: ...96 F4340_07496 F4340_10120 F4340_10120 F4340_10295 F4340_10295 F4340_20129 F4340_20129 F4340_20130 F4340_20130 F4340 5015 F4340 5015 F4340 5347 F4340 5347 F4340 20150 F4340 20150 F4340 20154 F4340 201...

Page 92: ...for 130 mm mattress PPB 060 With Headboard PPB061 With covers of Heaboard N Packaging PPB 090 Cartonbox on palette with indicator PPB 091 Overseas packaging without indicator PPB 092 Reinforced carton...

Page 93: ...Non sterile absorbent non permeable pad 874 STANDARD Non sterile non permeable supporting area cover 875 STANDARD Non sterile non permeable foot section cover 876 STANDARD Non sterile permeable leg re...

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