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Appendix

Operating manual NORA Pro

V0.1 E

Page 58 of 60

13.8 Journal

According to the “Medizinprodukte-Betreiberverordnung” (German Medical Devices
Operator Ordinance), you are compelled to keep a journal for this device. Observe your
applicable national / local legislation. You can use this journal as template.

Journal

Device:

Sit-to-stand lift

NORA Pro

Manufacturer:

BEKA Hospitec GmbH, Am Rübenmorgen 3, 35582 Wetzlar

Serial number:

_____________________________________________

Date of purchase:

_____________________________________________

Site:

_____________________________________________

Checks and inspection conducted upon the first use:

_____________________________________________________________________

Date:____________________________

Evidence of the training session on the functions and the use of the product

Instructor

Trained person

Name

Date

Name

Signature

Содержание 921077000

Страница 1: ...ator must familiarize himself with the scope of functions of the medical device by carefully reading this operating manual NORA Pro Sit to stand lift Version 0 1 E Subject to technical modifications 2022 05 05 Operating manual Information for use Original operating manual ...

Страница 2: ...ctions 9 5 Transport and storage 13 5 1 Unpacking the product 13 5 1 1 Removing the cardboard 13 5 1 2 Loosening the product from the pallet 13 6 Installation 14 6 1 Electrical connection 14 6 2 First start up 14 7 Operating elements and their function 15 7 1 Hand control 16 7 2 Functions and connections of the control unit 17 7 2 1 Control panel 17 7 2 2 Connections of the control unit 18 7 3 Bat...

Страница 3: ...to stand lift 36 9 2 Disinfecting the sit to stand lift 36 9 3 Sterilising the sit to stand lift 36 10 Maintenance safety checks and servicing 37 10 1 Prior to each use 38 11 Environmental protection waste disposal 38 11 1 Disposal of the packaging material 38 11 2 Disposal of the product 38 12 Troubleshooting After sales service 39 13 Appendix 41 13 1 Technical description 41 13 2 Dimensions of t...

Страница 4: ...pose please contact BEKA Hospitec GmbH Am Rübenmorgen 3 35582 Wetzlar Phone 49 0 641 9 22 20 0 Fax 49 0 641 9 22 20 20 info beka hospitec de BEKA Hospitec GmbH is certified according to DIN EN ISO 13485 by TÜV SÜD Product Service GmbH Therefore the development manufacturing quality assurance and service of our entire product range is subject to high quality standards ATTENTION Before each use chec...

Страница 5: ...ty and warranty On the basis of the information contained in this manual the publisher accepts no liability for damages resulting from improper incorrect or inappropriate use of the product The product must only be operated by persons who are familiar with the manual and the product as well as the national regulations laws and prescriptions related to work safety and accident prevention The manufa...

Страница 6: ...r future reference 3 2 Type plate This image shows the type plate The type plate is located at the column support of the NORA Pro The shown serial number SN is just an example In case of queries please mention the serial number printed on the type plate of your device Note Because of legal regulations it might be required that the article number and the serial number should be computer readable as...

Страница 7: ... observe the general warning and safety instructions in section 4 5 CAUTION Before the product is used adequately qualified nursing staff must assess the physical and mental condition of the patient resident In order to facilitate this corresponding assessments routines must and should be used in the daily care processes CAUTION The patient resident must have sufficient core stability capability o...

Страница 8: ...ressure limits minimum air pressure maximum air pressure CE label in accordance with MDR Humidity limits minimum humidity maximum humidity Name and address of the manufacturer Temperature limits minimum temperature maximum temperature Date of production Do not push pull the motor Do not push pull the spreader bar Warning hazardous area Washing temperature max 60 C Normal cycle Caution Do not bleac...

Страница 9: ...electrical equipment Part 1 General requirements for safety Operating Environment The product is exclusively fit for indoor use The product is not protected against the effects of greater mechanical forces and only to a limited extent against the penetration of splash water into the housing motor control unit and battery The device is not authorised for use in potentially explosive atmospheres or ...

Страница 10: ...ocated in the area of the castors or in the resident s area The operating time and the maximum load of the lifting unit must not be exceeded see 13 1 Technical description During the movement of the sit to stand lift the carrier frame must be closed Do not stand between the sit to stand lift and an obstacle during the transfer procedure Ensure that the power supply is always switched on throughout...

Страница 11: ...permitted without the patient being present The product contains detachable parts Observe chapter 7 for correct identification of the parts to avoid the risk of confusion and malfunction The product contains non removable parts If necessary these may only be replaced by personnel authorised by the manufacturer Observe the assembly instructions in chapter 13 6 Environmental protection waste disposa...

Страница 12: ...ications alterations are not permitted for safety reasons and shall exclude all liability of the manufacturer for the resulting damages For damages resulting from the use of spare parts or accessories which are not authorized by the manufacturer any further liability of the manufacturer shall be excluded CAUTION Do not leave the patient resident unattended at any time to avoid injuries falls or si...

Страница 13: ...oceed in the following way to remove the cardboard Cut the strap with the cutter knife Remove the strap Lift the cardboard up to remove it and put it aside 5 1 2 Loosening the product from the pallet Both sides of the product are strapped to the pallet Proceed in the following way to loosen the product from the pallet Unscrew the fixing screws of the straps Remove the straps and the cardboard unde...

Страница 14: ... Only when these conditions are met the manufacturer considers himself responsible for the impact on the safety the reliability and the function of the device In the event of a newly connected product the technical data must be observed HINWEIS The battery must be completely charged prior to the first use initial charging time min 12 hours Please check that the emergency stop switch is released pr...

Страница 15: ...tem 14 Tilting mechanism of the 3D Comfort System 5 Sling attachment points 15 Charger cable connection 6 Additional handles patient resident 16 Hand control 7 3D Comfort System Leg pad 17 Positioning handle user 8 Safety belts for the legs 18 Control panel 9 Detachable footplate 19 Battery 10 Spreadable carrier frame 20 Motor The contact surfaces of the NORA Pro are designed in a dementia sensiti...

Страница 16: ... has been exceeded 3 bars Battery is full no charging required remaining capacity 75 2 bars Battery is at least half full and can be charged remaining capacity 55 1 bar Battery is almost empty and must be charged remaining capacity 25 No bar Battery is almost empty and must be charged urgently remaining capacity 25 In addition a signal tone sounds when the button is pressed LED flashes orange Plea...

Страница 17: ... activated again The control panel also provides information about the operating status of your NORA Pro The charge level and if applicable overload can be read as described below 3 bars Battery is full no charging required remaining capacity 75 2 bars Battery is at least half full and can be charged remaining capacity 55 1 bar Battery is almost empty and must be charged remaining capacity 25 No b...

Страница 18: ...25V battery Proceed as described in chapter 13 6 1 to remove the battery WARNING Hazardous substances are contained in the batteries Do not open the batteries or manipulate them in any way If the contents of the battery should come into contact with skin or clothing wash the affected areas with plenty of water as soon as possible If any of the ingredients of the battery get into your eyes rinse th...

Страница 19: ... must not be used The external charging station can either be placed on a flat surface or attached to a suitable wall using the included mounting rail The required power supply unit is a switched mode power supply charger and is included in the scope of delivery As soon as the charging station is supplied with voltage the charging indicator LED lights up green If a battery is plugged in and charge...

Страница 20: ...e the rubber plug that closes the socket of the charging plug and insert the plug of the delivered power supply unit For internal charging make sure that the emergency stop switch is unlocked 7 5 Manual emergency lowering system Ensure that the patient resident can be lowered onto a suitable surface such as a chair or bed Turn the bright red emergency lowering knob clockwise until the spreader bar...

Страница 21: ...d be used immediately if there is immediate danger to the patient or the operating personnel However it can also be used to reduce discharging of the battery during intermediate storage In addition you can lock the NORA sit to stand lift by pressing the emergency stop switch and thus make unauthorised use more difficult Unlocking Before use check whether the emergency stop switch is unlocked To un...

Страница 22: ...Impact and jamming protection hoist motor The electrical motor hoist motor features an integrated impact and jamming protection free wheeling This feature avoids jamming pinching and or crushing dangers when the spreader bar of the NORA sit to stand lift strikes or encounters an obstacle The motor runs free until the obstacle is removed or the NORA sit to stand lift is removed from the obstacle Af...

Страница 23: ...ault attachment points for people taller than 1 60 m The two inner attachment points are optimally adapted for people with a body height of less than 1 60 m WARNING Observe the instructions for use of the sling Always make sure that the fastening clips are secured and in the correct position before lifting your patient resident Default sling attachment point Attach sling with sling clip 1 Optional...

Страница 24: ...leg The counterpressure of the knees forms precisely fitting hollows that provide comfortable and secure support when standing up The additional tilting mechanism also improves the even sinking in of the leg for patients residents with different body heights 7 10 1 Detachable leg separator option The leg separator made of skin friendly PE material is placed on the 3D Comfort System from above and ...

Страница 25: ...eg strap from the retractor from behind and place it around the patient s resident s calf Click the Belt connector audibly into the belt buckle to close it Due to the retractor mechanism the leg strap automatically tightens and adjusts to the patient s occupant s legs Repeat this procedure with the other leg During the raising process keep the leg safety belts closed Opening the leg strap To open ...

Страница 26: ...foot plate Take the footplate in both hands Lift the footplate slightly upwards so that it releases from the suspension at the back Now remove the footplate by pulling it forward Hanging up the footplate Take the footplate in both hands Put the metal opening at the back of the footplate back into the mounting Now lower the footplate and let it snap into place Make sure that the footplate is again ...

Страница 27: ... rear castors of the NORA Pro have brakes and can be locked Locking the brake Press the light grey castor brake down with your foot illustration left red arrow Releasing the brake Press the light grey castor brake upwards with your foot illustration on the right green arrow Castor Brake unlocked locked ...

Страница 28: ...f infections to an absolute minimum in the event that the same equipment is used for other residents or patients CAUTION Prior to each use a thorough check of the sling including the loops and the fastening clips is imperatively required If the sling or the loops would be frayed cut in or damaged or the clips would be damaged the sling no longer must be used CAUTION Make sure that the sling form a...

Страница 29: ...handles of the spreader bar 8 1 2 1 Safely attaching the clips to the support Always check that the fastening clips are secured and correctly positioned prior to lifting the patient resident 8 1 2 2 Safely attaching the slings Step 1 Carefully lower the spreader bar by pressing the down button of the hand control until you can slide the slings over the attachment hooks Step 2 Pull the sling over t...

Страница 30: ...anding position and make the transfer as short as possible Avoid slippery surfaces and thresholds and do not move the product over sloping or uneven floors Make sure that the resident is not hurt by the door frame when passing through doors CAUTION Activate the brakes of the castors of the wheelchair the healthcare bed the stretcher etc to ensure a safe lifting and positioning of the resident To t...

Страница 31: ...e spreader bar Make sure that the patient seizes the handles provided to that effect with both hands Make sure that no one grabs in the hazardous areas bracket carrier frame during the adjustment procedure Risk of crushing Check before and during the height adjustment procedure that your feet are not located in the area of the castors or in the resident s area 9 You can now raise the patient resid...

Страница 32: ... arms are located outside the sling 3 Spread the legs of the carrier frame and lower the spreader bar completely 4 Position the NORA in front of the patient and adjust it so that the patient s legs are resting on the 3D Comfort System and form a right angle with the thighs The patient s feet must be located in the middle of the footplate 5 Activate the brakes on the rear castors 6 Tighten and fast...

Страница 33: ...g manner 1 Spread the carrier frame if needed up to the maximum possible spread width 2 Bring the sit to stand lift with the patient resident over the intended location 3 Check that the chair or the bed stands safely activate the brakes of the wheelchair if required 4 Lower the lifting arm with the spreader bar until the patient resident sits safely in the chairs or on the bed and the loops of the...

Страница 34: ...ped Display maximum weight When the LED display next to the weight symbol of the hand control lights up the maximum possible lifting weight of the NORA sit to stand lift has been reached The weight symbol with the signature Overload also appears on the display on the control unit In such case lower the patient and use another sit to stand lift with a higher load capacity Spreading the carrier fram...

Страница 35: ...eas In particular it makes it easier for the nursing staff to change nappies and other aids The leg separator is attached to the 3D Comfort System from above and can be removed again by pulling it slightly upwards see photo in chapter 7 10 8 7 Maintenance and care of the battery The battery and the control box must not be opened by the customer Repairs may be carried out only either by BEKA Hospit...

Страница 36: ...aning agent for plastics Do not use scouring agents or other aggressive cleaning agents and disinfectants Grease stains residues of skin and hair can be removed with a sponge and soap Please do not use abrasives to clean the sit to stand lift To avoid damages no aerosol cleaners sprays abrasive cleaners or solvents must be used to clean the control unit Please remember that all warranty claims reg...

Страница 37: ...servance may result in injuries or an unsafe product In case of doubt please contact your supplier or manufacturer NOTE In accordance with the UVV accident prevention regulations of the German employer s liability insurance association on mobile equipment which is used in special locations or installations the product must be subject to an annual check to the DGUV German Statutory Accident Insuran...

Страница 38: ...rds the environment The product must not be disposed of with household waste 11 1 Disposal of the packaging material Please recycle the packaging materials of the product in accordance with the locally applicable regulations and laws The metal parts as well as the plastic and electronic components must be recycled in accordance with the WEEE 11 2 Disposal of the product The expected operating life...

Страница 39: ...s not run a Check if the emergency stop switch is released or pressed b Check that the control box is correctly plugged in c Check the battery s charging state replace with fully charged battery Heavy going sluggish operation of the drive despite fully charged battery a Battery low Charge the battery b The maximum load is exceeded max patient weight c The battery has reached the end of its lifetim...

Страница 40: ...edy The battery is placed correctly but the indicator lights are not lit Inform the after sales service The indicator light does not go out after multiple hours of charging The battery must be replaced Inform the after sales service The battery installed in the charging unit indicates that it is fully charged However when placed in the NORA Pro just a few lifting cycles are possible The battery mu...

Страница 41: ...the closed carrier frame 703 mm Width in open condition internal dimension 910 mm External width of the spread carrier frame 1063 mm External width at the handle 704 mm Min height 1091 mm Max height 1659 mm Turning radius 1263 mm Weight without packaging 50 kg Safe Working Load SWL max 205 kg Nora Pro IP degree of protection Sit to stand lift IPX4 Hand control IPX6 Operating mode Operating mode he...

Страница 42: ...ed Storage and transport Temperature range lift 40 C to 70 C 40 F to 158 F Temperature range battery 10 C to 40 C 14 F to 104 F Relative humidity 10 to 80 non condensing Atmospheric pressure 86 kPa 110 kPa Battery charger Input voltage 100 V 240 V AC 50 60 Hz Output voltage 25 V DC Power consumption I in max 0 8 A Fuse T1 25 250 V Protection class IPX4 Battery Battery type Lithium ion battery Outp...

Страница 43: ...Appendix Operating manual NORA Pro V0 1 E Page 43 of 60 13 2 Dimensions of the NORA Pro ...

Страница 44: ...Appendix Operating manual NORA Pro V0 1 E Page 44 of 60 13 3 Connection and assembly diagram Observe the information given in chapter 6 Installation ...

Страница 45: ...Appendix Operating manual NORA Pro V0 1 E Page 45 of 60 13 4 Declaration of Conformity ...

Страница 46: ...Appendix Operating manual NORA Pro V0 1 E Page 46 of 60 ...

Страница 47: ...Appendix Operating manual NORA Pro V0 1 E Page 47 of 60 ...

Страница 48: ...Appendix Operating manual NORA Pro V0 1 E Page 48 of 60 ...

Страница 49: ... NORA Pro Size XL 921078040 921078040D Raising sling NORA Pro Size XXL 921078050 921078050D For Germany the article numbers ending with D apply Guidelines for sling sizes NORA standing raising sling with clip Description Guidelines for sling sizes Nylon material Arm rest and back part with anti slip coating with safety belts for the belly part and additional padded chest strap Sling attachment poi...

Страница 50: ...Appendix Operating manual NORA Pro V0 1 E Page 50 of 60 Please note You cannot exchange and replace all spare parts by yourself The assembly requires the knowhow of a qualified expert ...

Страница 51: ...ctly replaced Replace only with the same or equivalent type Image 1 The image shows the inserted battery Image 2 Unlock the battery by means of the release lever in the battery handle Image 3 Pull the battery towards the front to remove it Image 4 The image shows the removed battery When replacing the battery please check that the release lever engages audibly ...

Страница 52: ...ontrol Image 2 Open the connection flap by releasing the two securing hooks on the side e g with a slotted screwdriver Image 3 Remove the plug of the hand control from the control box right plug Image 4 Now you can remove the hand control and replace it with a new one Pay attention to the coding groove when inserting the plug ...

Страница 53: ...cy stop button Remove the battery as described in chapter 13 6 1 Image 4 Open the connection flap and disconnect all plug connections from the control unit Hand control Lifting motor Spreader motor Charging plug if applicable Image 5 The picture shows all removed plug connections Image 6 Loosen and remove the screws with cross head screwdriver PH1 Image 7 Pull the control unit upwards out of the h...

Страница 54: ...after listed ELECTROMAGNETIC ENVIRONMENTS The customer or the user of the product must ensure that the appliance is used in such environment Emission measurements Compliance Electromagnetic environment guidelines High frequency HF emissions to CISPR 11 Group 1 The product uses HF radiation exclusively for internal functions Therefore the HF radiation of the device is very low and any interference ...

Страница 55: ...y of the supply voltage should match that of a typical business or hospital environment Overvoltage IEC 61000 4 5 1 kV cable against cable 2 kV cable against ground connection 1 kV cable against cable 2 kV cable against ground connection The quality of the supply voltage should match that of a typical business or hospital environment Voltage drops short interruptions and voltage fluctuations in th...

Страница 56: ...fixed HF transmitters as determined by an electromagnetic field survey a should be less than the COMPLIANCE LEVEL in each frequency range b In the vicinity of equipment marked with the following symbol interference may occur NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 This manual could possibly not apply to all situations Electromagnetic propagation is affected by absorp...

Страница 57: ...nding on the transmitting frequency in m 150 kHz to 800 MHz d 0 35 P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 5 GHz d 2 3 P 0 01 0 1 1 10 100 0 04 0 11 0 35 1 1 3 5 0 12 0 38 1 2 3 8 12 0 23 0 73 2 3 7 3 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be determined using the equation applicable to the frequency of the transmi...

Страница 58: ...lift NORA Pro Manufacturer BEKA Hospitec GmbH Am Rübenmorgen 3 35582 Wetzlar Serial number _____________________________________________ Date of purchase _____________________________________________ Site _____________________________________________ Checks and inspection conducted upon the first use _____________________________________________________________________ Date _______________________...

Страница 59: ...Appendix Operating manual NORA Pro V0 1 E Page 59 of 60 Periodic inspection repair DGUV 3 safety check etc Type of inspection Date Result Measure Signature ...

Страница 60: ...BEKA Hospitec GmbH Am Rübenmorgen 3 35582 Wetzlar Germany Phone 49 6 41 9 22 20 0 Fax 49 6 41 9 22 20 20 ...

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