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Zimmer aXon, Руководство пользователя

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Zimmer aXon Скачать руководство пользователя страница 31

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Declaration of conformity 
 
 
 

17 

 

 

 

 

 

This product carries the CE mark 

  in accordance with the EU Directive on Medical Devices 

93/42/EEC and conforms to the basic requirements of Annex I of this Directive. 
 
The product has been developed, manufactured and tested using the quality management system in 
accordance with DIN EN ISO 13485. 
 
The product is classified in Class I in accordance with Annex IX of the Directive. 

 

 

 

 

 

 

 

Содержание aXon

Страница 1: ...User Manual aXion GB ...

Страница 2: ...al 15 11 3 Adjusting the headrest position 16 12 Accessories and features 19 13 Possible faults and how to correct them 22 14 Maintenance and care 23 14 1 Cleaning the padded surface 23 14 2 Tested and recommended cleaning agents 24 14 3 Cleaning the frame 24 14 4 Cleaning the piston rod of the linear drive 24 14 5 Disposal 24 15 Specifications 25 16 Manufacturer s EMC declaration 26 17 Declaratio...

Страница 3: ...y changing we reserve the right to make technical and design changes Please follow all instructions and information in this manual to ensure safe and successful operation As the owner of the device you are required to comply with all current instructions and precautions for electrically height adjustable treatment benches The aXion series benches are not designed or intended for patient transport ...

Страница 4: ...sent and the future of your work and its value Professional equipment for professionals Zimmer MedizinSysteme is a CE ISO certified company and is continuously working on improving the availability of therapy systems and aids in physical medicine Our experience continuous development and observation of innovations coupled with close contact to medicine throughout the world mean safety and trust fo...

Страница 5: ...tions of safety regulations that may result in imminently dangerous situations which may cause death or severe injury Warning A section highlighted by the warning symbol describes possible violations of safety regulations that may cause injury to persons or damage to devices Caution A section highlighted by the caution symbol describes possible violations of safety regulations that may cause minor...

Страница 6: ...nt when adjusting the height The therapist or user is always responsible for preventing uncontrolled or unwanted adjustments Patients are not permitted on bench during adjustment or transport The bench must be kept clear of any obstacles above or below the range of movement e g window sills stools When conducting therapy using heaters infrared lamps or other products keep the devices clear of the ...

Страница 7: ...e power cord with the bench wheels When using add on devices or third party devices e g infrared lamps the user must check that they are compatible and also ensure that the bench cannot be accidentally moved or adjusted Observe any product specific safety clearances and instructions Uncontrolled adjustments may reduce the distance enough to cause burns by proximity or direct skin contact The cushi...

Страница 8: ...ust be noted on the freight documents presented by the transport company before acknowledging receipt Please send information about shipping damage to Zimmer MedizinSysteme GmbH immediately Opening The shipment must be checked for damage immediately on receipt If any damage is found inform Zimmer MedizinSysteme GmbH in writing within two business days Any claims for shipping damage cannot be accep...

Страница 9: ...rs a two year warranty on the complete bench with the exception of the upholstery on the headrest wear part which has a six month warranty Zimmer MedizinSysteme GmbH must be immediately notified of any parts that prove to be defective within the warranty period and after prior arrangement these must be returned to us for assessment of damages No further warranty or liability specifically for conse...

Страница 10: ... therapeutic and diagnostic purpose The therapist is responsible for its use This medical device is intended for use in enclosed rooms at an ambient temperature between 15 C and 35 C It must not be used in wet areas If it is used in wet areas significant damage may result and patients and users may be endangered The aXion series benches are not designed or intended for patient transport Patients a...

Страница 11: ...erve the applicable national laws and regulations when setting up and using this therapy bench In Germany the applicable regulations are the MPBetreibV Medical Devices Operator Regulations in the current version and BGV A3 ...

Страница 12: ...agnetic key pin into the slot on top of the safety lock The bench is now ready for use Now sequentially activate all the controls for adjusting the height of the bench ensuring that it cannot be moved beyond the end positions Note the height of the bench can only be adjusted with the safety lock activated magnetic key inserted After the function test either remove the magnetic key from the safety ...

Страница 13: ...ustable left right 4 Lock for arm rest height adjustment 5 Upper torso cushion 6 Middle torso cushion 7 Leg cushion 8 Scissor frame 9 Centre axis 10 Lift motor 11 Activation lever for all direction wheel system optional 12 Wheel standard 13 Foot switch for height adjustment 14 Hand switch for height adjustment position ...

Страница 14: ...13 Complete drawing 10 aXion 2 aXion 3 aXion 4 aXion 5 aXion 6 80 30 aXion 3 aXion 5 90 30 20 cm aXion 6 90 ...

Страница 15: ...witch if required The hand switch can be attached to the holder on the bench frame with the fixed retainer Adjusting the height with the foot switch standard with Comfort model otherwise optional The bench height can also be adjusted using a foot switch Press the appropriate membrane button with the foot to raise or lower the bench Note the membrane buttons should only be operated using light pres...

Страница 16: ...uctions described previously for use of the safety lock for therapeutic operation Caution Adjustments or repairs to the membrane buttons must be conducted by authorised dealers and service representatives of Zimmer MedizinSysteme GmbH only 11 2 Moving the bench with all direction wheel system optional The universal wheels are combined with an integrated wheel lifting system Press the foot lever do...

Страница 17: ...d may be damaged or cause injury The maximum load on the head rest is 30 kg 65 lb Releasing head rest adjustment Press the release handle up underneath head rest Adjusting head rest Hold the handle and move the head rest to the desired position between 30 and 90 Locking head rest Release the handle to lock the head rest at the desired position between 30 and 90 The head rest is fitted with a face ...

Страница 18: ...te To prevent injury any adjustments should be made by only one person a Lift the arm rest forward to adjust the height b Move the arm rest to the desired height c The arm rest is automatically locked in position when it is released It can also be fixed in position with the clamping screw d As well as separate height adjustment the arm rests can be swivelled to any position with a lock function in...

Страница 19: ...functions 11 Push lever to the side and up This releases the gas spring and raises the upholstery With recumbent patients the upholstery must be lifted slightly with the other hand depending on the weight of the patient ...

Страница 20: ...egulations Head rest with face insert adjustable 90 to 30 6 cm upholstery with synthetic leather cover and undercover fastening 6 cm comfort upholstery with additional durable edge stitching Seam and box shape synthetic leather cover Arm rests height adjustable and swivelling One section bench top Bench top two section leg rest adjustable 80 with gas spring 50 50 divided Bench top three section fl...

Страница 21: ...20 Accessories and features 12 Arm rest adjustment All direction wheel system with smooth swivelling wheels Membrane button for height adjustment ...

Страница 22: ...e parts Electrical hoist motor 50 870 170 Gas spring head cushion seat adjustment flexion position 50 870 180 Head cushion 50 870 210 Face insert for head cushion 50 870 220 Arm rest cushion right 50 870 230 Arm rest holder right 50 870 240 Arm rest cushion left 50 870 250 Arm rest holder left 50 870 260 One section bench top cushion 50 870 270 aXion 2 4 Torso cushion top 50 870 280 aXion 6 Torso ...

Страница 23: ...e result that the internal motor protection has shut the motor off Wait for the motor to cool down However if the bench still does not operate after checking the hand switch foot switch cables plug and power supply there may be a fault in the mains power supply cables drive unit or the hand or foot switches Note Adjustments or repairs to the power transmission components must be conducted by autho...

Страница 24: ...Skai brand provides top quality the upholstery should not be subjected to severe mechanical and chemical treatment Sharp or heavy objects must not be placed on the bench nor should it be used as a testing ground for the effects of chemicals For hygienic reasons we recommend the use of a protective sheet textile or paper The padded surface should be cleaned after every treatment as specified by hyg...

Страница 25: ...Ensure that moisture cannot penetrate the joints 14 4 Cleaning the piston rod of the linear drive The piston rod must be wiped at intervals with a soft cloth to prevent dust causing damage to the piston rod seal of the linear drive 14 5 Disposal Zimmer MedizinSysteme GmbH will dispose of parts that cannot be repaired Do not dispose of the bench as bulk waste Name Max concentration Manufacturer Inc...

Страница 26: ...lstery cover Synthetic leather Upholstery thickness 6 cm Head rest Adjustable from 30 positive to 90 negative with gas spring Motor 230 V AC 50 Hz 0 9 A 145 W 8000 N Protection Class II IP66 intermittent operation 1 min 9 min Tests CE EMC Weight of standard width aXion 6 110 kg aXion 4 105 kg aXion 2 98 kg Max load capacity 180 kg static 160 kg dynamic optional ...

Страница 27: ...environment as specified below The customer or the user of the aXion therapy bench must ensure that it is used in such an environment Emissions tests Compliance Electromagnetic environment guideline HF emissions CISPR 11 Group 1 The aXion therapy bench uses HF energy solely for its internal functions Its HF emissions are therefore very low and are not likely to cause any interference in nearby ele...

Страница 28: ...al or hospital environment Surges as per IEC 6100 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips brief interruptions and fluctuations in power supply as per IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycle...

Страница 29: ...mitter manufacturer and d is the recommended separation distance in metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site surveya should be less than the compliance level in each frequency rangeb Interference may occur in the vicinity of equipment which is marked with the following symbol NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher fre...

Страница 30: ...equency of transmitter m Rated maximum output of transmitter W 150 kHz to 80 MHz d 1 17 P 80 MHz to 800 MHz d 1 17 P 800 MHz to 2 5 GHz d 2 33 P 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 17 1 17 2 33 10 3 70 3 70 7 37 100 11 67 11 67 23 33 The recommended safety distance d in metres m for transmitters whose maximum nominal output is not listed above can be calculated using the equation that belon...

Страница 31: ...n Medical Devices 93 42 EEC and conforms to the basic requirements of Annex I of this Directive The product has been developed manufactured and tested using the quality management system in accordance with DIN EN ISO 13485 The product is classified in Class I in accordance with Annex IX of the Directive ...

Страница 32: ...mmer MedizinSysteme GmbH Junkersstraße 9 D 89231 Neu Ulm Tel 49 731 97 61 291 Fax 49 731 97 61 299 export zimmer de www zimmer de User Manual GB 10 101 664 UR 0709 I Right of modifications reserved aXion ...

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