Instruction manual - TekVor-Care
Contents
1. distance from mattress without load 12 cm to upper edge of sideguard rail 22 cm 75mm with individually lockable brake 100 kg static 106 kg lt 53 db A at a distance of 1m control unit MC210 SMPS MC125 230 240V 50 60 Hz User Manual 13 3 13 4 13 5 Type of current Nominal consumption during operation Nominal consumption in idle state Nominal operating time Nominal idle time Primary safety fuse Battery for emergency lowering Mattress base motor unit back knee Height adjustment motor unit Motor unit protection class Technical Data Surroundings Temperature range during operation Temperature range for storage transport Humidity of the air Air pressure Classification Medical product Degree of protection to DIN EN 60601 1 Housing degree of protection to 60259 Max duty rating Max switching cycles min Safety inspections Care Bed ECOFIT ULTRA TekVor Care AC 250 Watt 0 Watt 2 Min 18 Min max 5 switching cycles min 2 0A 9V block battery alkaline manganese type 6LR61 2x MD120 Fa LIMOSS 2x MD120 Fa LIMOSS IPX6 10 C to 40 C 10 C to 60 C 30 to 75 rel between 700 and 1060 hPa Class 1 i Type B protection against electric shock IPX 6 suitable for automated washing systems 10 ON 2 min OFF 18 min 5 1x per year Weights of the I ndividual Components Mattress base Head side incl motor Mattress base Foot side incl motor2. www rki de gt you will find a list dated of 31 05 20070f approved and generally accepted disinfection agents and treatments and how they are to be correctly used IMPORTANT Before cleaning and disinfection the mains plug must be unplugged and hung up safely SN Plugs for the handset and the motors which are inserted in the control unit MUST remain plugged in This is necessary to ensure that water does not get into the control system 9 Trouble Shooting Before you contact your authorised distributor please use the following table to check Fault___________ Possiblecause Remdyy Mains plug not plugged in Insert mains plug into mains socket No response activated base motor base motor Adjustment functions Connecting cables on the Check plugs and connectors transposed connectors transposed and change over plugging in locations No function after power 9V block battery is Replace 9V block battery failure discharged Bed only moves very Bed only adjusted via the Plug in mains plug and replace Slowly battery Mains plug not the 9V block battery as a plugged in precaution Page 24 of 36 User Manual Care Bed ECOFIT ULTRA TekVor Care 10 Servicing 10 1 Principles Operators of care beds are obliged according to MPBetreibV Operators of Medical Products Ordinance 4 to guarantee the safe condition of the medical product over their entire service life The test according to the regulation EN 62353 contains the
3. Cleaning and Disinfection The bed including electrical components is IPX6 suitable for automated washing systems Before cleaning and disinfection the mains plug must be unplugged and hung up safely Please note all the plugs must be fitted into the control box to keep the componants water tight Please also check the condition of the rubber o rings on the sleeping platform joints if the o rings are damaged or missing they must be replaced DO NOT WASH THE BED WITHOUT INTACT O RINGS FITTED Always wear waterproof gloves when cleaning and disinfecting to avoid skin irritation Attention In the event of disinfection by spraying on a large scale with products containing alcohol there is a danger of explosion and fire Servicing and Maintenance Servicing work must only be carried out by persons who have at least read the safety regulations and are qualified according to the MPBetreibV Operators of Medical Products Ordinance 4 and 6 A technical check and or safety inspection must be conducted at least once a year and after a lengthy break in use There is section 10 2 for this purpose Any defects damage or signs of wear must be eliminated without delay Only original Spare parts from TekVor Care may be used otherwise all guarantees or warranties will be excluded Please check all fixings on your bed at least once a month Pay special attention to side rail components and sleeping platform connections The 9V block battery is the ene
4. Head end Foot end lifting steel frame incl motor and white plastic panel or transparent vision board as option Aluminium side guards with end caps Patient s lifting pole Grab handles Transporting device 22 5 kg 21 kg 18 5 kg each 16 2 kg set of 6pcs 4 2 kg optional accessory 3 1 kg pair optional accessory 3 4 kg Page 29 of 36 User Manual Care Bed ECOFIT ULTRA TekVor Care 13 6 Type Plate Attached to the right inside surface of the mattress base frame See Overview 12 345678 9 10 11 12 2013 2014 TekVor Care GmbH am TE KV OR CARE are hee 51647 Gummersbach We care for you Germany Tel 49 0 2261 501860 Fax 49 0 2261 5018620 ECOFIT ULTRA SN 13 0200300001 230 240V 50 60Hz 250W IPX6 P FUNCTION 2 MIN PAUSE 18 MIN a gt SA Dee Arm CE Page 30 of 36 User Manual Care Bed ECOFIT ULTRA TekVor Care 13 7 Information about electromagnetic emissions Guidance and manufacturer s declaration electromagnetic emissions The care bedis intended for use in the electromagnetic environment specified below The customer or user of the care bed should ensure that it is used in such an environment Emitted interference RF emissions according to CISPR11 RF emissions according to CISPR11 Emissions of harmonics according to IEC61000 3 2 Emissions of voltage fluctuations Flicker according to IEC 61000 3 3 Compliance Electromagnetic Environment Guidelines Group 1
5. TEKVOR CARE gt We care for you Instruction manual Homecarebed ECOFIT ULTRA TekVor Care GmbH Fraunhoferstra e 8 51647 Gummersbach Germany T 0049 0 2261 50186 0 F 0049 0 2261 5018620 Email info tekvor care com Stan d 23 04 2013 web www tekvor care com User Manual Care Bed ECOFIT ULTRA TekVor Care Foreword 1 General nformation cioaca alu teas cence aaa a deen See 1 1 Explanation of the Symbols Used cccccecseseeeeeteeeeeseeeeeeeeseeeeseeeesesseeeteesensrseneres 1 2 Definition of the Groups of Persons Involved ccceceeseteeeeeeeeetereeseeeeeeteeseeaeeetaees 2 Intended Purpose i ate tc ea Zi Use tor the P rpose Intended num een 22 NOR COMPIANE SC ran aa aa a aaa aa a Tr a AREA she aa ed 3 General Regulations for Users u240200200 n0nn0nnonnn nun eee eee eee nnn nennen 31 Qualitication or Users 4 Safety Instructions ansht ersten at o aa a EN a le at i ls 0 ul 4 1 4 1 General Safety Instructions cccceccessscesescercesseeueureesueeuseeerseeauseeereesarsesuresnares 4 2 Safety Information for the Operator ccsccecseceeseceeseceeceeeeeeseeeeseeeesesseseteesessneesares 4 3 Safety Information for the User ccccssecssescereeeseeeeurersecaueueersesaeeueureeneeaunseerseeanees 44 Cleaning and Disinfection a 4 5 Servicing and Maintenance ii 4 6 ACCESSO IES tennis 4 7 Electromagnetic Compatibility cccccccsess
6. visible damage to the transport company immediately After unpacking check that all following parts are present Transportvorrichtung TAV perie a a _ f mu er 6 aluminium side guards 6b with caps delivered with the p om base as a separate m package Backrest section with mounted backrest actuator and control box Legrestsection with mounted kneebreak actuator 2x height adjustable bed ends with mounted actuators and castors 4a Monkey pole optional with triangle grip and strap 4b 5a power supply with cord and plug Page 12 of 36 User Manual Care Bed ECOFIT ULTRA TekVor Care 6 2 e 5b handset with locking device e 6a 6 pcs aluminium sideguards and 12 plastic end caps 6b in a separate package e Instruction manual Removal from the Transporting Device Lift the cover from the whole bed unit including the transporting device m a ie Cut through the packaging strips using a side cutter or a pair of scissors iu er ee ae ce eee ie First lift the mattress base section for the foot end out of the transporting device and then lift out the mattress base section for the head end of the bed 1 Mattress base section for the foot end 2 Mattress base section for the head end Check the condition of the rubber o rings here If they are damaged or missing they should be replaced immediately Two spare o rings are supplied
7. The care bed is intended for use in the electromagnetic environment specified below The customer or user of the care bed should ensure that it is used in such an environment eter nce I EC 60601 Compliance Electromagnetic Environment I mmunity eae VE Test Level level Guidelines Certification Portable and mobile radios including cables should not be used closer to the care bed than the recommended working clearance that is calculated by the equation for the appropriate frequency 13 7 1 1 1 1 1 1 13 7 1 2 1 1 1 2 Recommended working clearance Conducted RF 3V eff se interferences according to g P IEC 61000 4 6 150 kHz 80 MHz d 57 Emitted RF interferences 3 V m according to IEC 61000 4 3 5 3 80 MHz 2 5 GHz d F WP for 80 MHz 800 MHz 1 d NP for 800 MHz 2 5 GHz 1 where P is the power of transmitter in watts W according to specifications of the transmitter manufacturer and d is the recommended working clearance in meters m Field strengths from fixed RF transmitters should at all frequencies according to a site survey te P gt be lower than the level of agreement be BNE Dre In the vicinity of equipment bearing the following symbol interference is possible O Note 1 At 80 and 800 MHz the higher frequency range must be taken Note 2 These guidelines may not apply in all situations The propagation of electromagnetic waves is affected by absorption and reflecti
8. our ECOFIT ULTRA care bed With your decision to buy a care bed from TekVor Care you have a care product with a high degree of functionality and the highest level of safety With the care bed you have purchased we can guarantee maximum comfort and a professional standard of care All beds are scrupulously tested by our company before leaving our premises The care bed delivered to you left our factory in perfect condition When you accept delivery of the care bed the responsibility for proper use according to the purpose intended passes to you at the same time This instruction manual informs you as the operator and your users about the functions and safe handling of this care bed on a daily basis Please keep the instruction manual near the care bed at all times We are confident that this product will play an important role in care giving Yours sincerely TekVor Care Team Page 4 of 36 User Manual Care Bed ECOFIT ULTRA TekVor Care 1 1 General Information Before putting the bed into service for the first time Read through this instruction manual conscientiously from start to finish Please note in particular that the various safety instructions must be observed Clean and disinfect the care bed before using it for the first time TekVor Care care beds bear the CE mark and meet all safety and functionality requirements These care beds were tested according to the international standards which contain the safety requ
9. 1 1 2 2007 see section 13 7 But it is possible that electrical devices interfere with each other In this case switch off the care bed for a short time or remove the interference source We refer to the position paper of the BfArm reference n 9 0508 Bundesinstitut fur Arzneimittel und Medizinprodukte Storage If the care bed is stored for a lengthy period the 9V block battery should be removed as otherwise it would be subject to a higher rate of self discharge Service Life and Disposal The normal service life for care beds in domestic use is approx 5 years The care bed must not be disposed of as normal domestic waste after its service life has expired To ensure that it is disposed of in an environmentally compatible way please get in touch with TekVor Care Storage and Transport Due to its modular construction the care bed can be easily transported This is made possible by a transporting device The care bed integrated in the transport rack can be manoeuvred in very small spaces due to the bed s castors Page 11 of 36 User Manual Care Bed ECOFIT ULTRA TekVor Care 7 State as delivered Care bed in the transporting device Please do not dispose of the cover This can be used again as a dust cover in the event that the care bed is later stored in the transport rack Installation and Commissioning Pre installation inspection On delivery and before installation check that the packaging is undamaged Report any
10. The care bed uses RF energy only for its internal functioning Therefore its RF emissions are very low and it is unlikely that nearby electronic devices will be disturbed The care bed is designed for use in all establishments including domestic establishments and those Class B determined to be directly connected to a public supply network that supplies buildings used for residential purposes Page 31 of 36 User Manual Care Bed ECOFIT ULTRA TekVor Care Guidance and Manufacturer s Declarations Electromagnetic nterference mmunity The care bed is intended for use in the electromagnetic environment specified below The customer or user of the care bed should ensure that it is used in such an environment Interference Immunity Certification Electrostatic discharge ESD according to IEC 61000 4 2 Electrical fast transients bursts according to IEC 61000 4 4 Surges according to IEC 61000 4 5 Voltage dips short interruptions and supply voltage variations according to IEC 61000 4 11 Magnetic field of power frequency 50 60 Hz according to IEC 61000 4 8 IEC 60601 Test Level 6 kV contact discharge 8 kV air discharge 2 kV for power lines 1 kV for input and output lines 1 KV Voltage phase phase conductor 1 KV Voltage phase ground conductor lt 5 Ur for 2 cycle gt 95 dip 40 Ur for 5 cycles 60 dip 70 Ur for 25 cycles 30 dip lt 5
11. Urfor 5s gt 95 dip Compliance level 6 kV contact discharge 8 kV air discharge 2 kV for power lines 1 kV for input and output lines 1 KV Voltage phase phase conductor 1 KV Voltage phase ground conductor lt 5 Ur for 1 2 cycle 10 ms gt 95 dip 40 Ur for 5 cycles 100 ms 60 dip 70 Ur for 25 cycles 500 ms 30 dip lt 5 Urfor 5s gt 95 dip Page 32 of 36 Electromagnetic Environment Guidelines Floors should be wood concrete or ceramic tile floors If the floor is covered with synthetic material the relative humidity should be at least 30 The quality of the supply voltage should be equivalent to that of a typical business or hospital environment The quality of the supply voltage should be equivalent to that of a typical business or hospital environment The quality of the supply voltage should be equivalent to that of a typical business or hospital environment If the user of care bed also requires continued operation during interruptions in energy supply demands it is recommended to feed the care bed from an uninterruptible power supply or a battery Magnetic fields of power supply frequency should comply with the typical values as can be found ina business and hospital environment User Manual Care Bed ECOFIT ULTRA TekVor Care Guidance and Manufacturer s Declarations Non life support devices Electromagnetic I nterference mmunity
12. aked position e Use of the care bed on a non horizontal surface max incline 5 General Regulations for Users The care bed must only be used for the purpose intended When setting up operating and using the care bed the regulations of the Medical Products Act German abbreviation MPG Medizinproduktgesetz and the legal provisions decreed in this respect the general recognised rules of technology and the occupational health and safety and accident prevention regulations must be complied with If the care bed is in a faulty state in which the patient occupant care personnel or third persons could be endangered operation may not be started Qualification of Users The care bed must only be operated by persons who have the corresponding training or experience to enable them to handle the care bed correctly Page 7 of 36 User Manual Care Bed ECOFIT ULTRA TekVor Care 4 4 1 gt Safety I nstructions General Safety I nstructions During the briefing specific attention must be drawn to any potential dangers which can occur despite correct operation Before putting the care bed into service for the first time the Instruction Manual must be read conscientiously and in detail by the user care personnel When operating the adjusting functions there must not be any objects or people s limbs in the plane of movement of the care bed Risk of crushing Do not sit on the leg section of the bed when operating the raise func
13. and fixed to the Remove the cable ties from the handset and the mains cable Mains cable Caution Do not damage the cable Remove the height adjustable head and foot end panels from the transporting device To do this release the spring loaded catches that are later used to fix the height adjustable head and foot end panels to the mattress base Page 13 of 36 User Manual Care Bed ECOFIT ULTRA TekVor Care 6 3 Pull out and turn through 90 Mounting lugs for the mattress base Assembly of the Care Bed Remove the cable tie from the backrest motor including the attached mains adapter and from the thigh rest adjustment motor Attention Keep firmly hold of the motor in question when loosening the cable tie because the motors can fall when they are not secured in place with safety bolts Backrest motor Thigh rest adjustment motor Please note The actuators arrive in the transport position If the bed is operated with the actuators in this position it will result in the premature failure of the actuator sleeping platform Remove the safety bolt then move the actuator into position and re install the Safety bolt Connect the fork heads of the motor units with the terminal links on the mattress base To do so use the safety bolt which is inserted into the hole for the terminal links In order to loosen the bolt throw the safety lever Attention The safety lever must be locked again after connect
14. ble to the SMPS transformer box the two plugs for the electric motors and the plug for the thigh rest adjustment Now remove the motor with the control unit from the mattress base by removing the two supporting safety bolts from the motor ATTENTION Hold on to the backrest motor when loosening the safety bolts to prevent it from falling onto the floor Remove both safety bolts from the backrest motor You can now open the cover yellow with battery symbol on the control unit housing with a Philips screwdriver and remove the 9V battery and replace it with a new type 6LR61 alkaline manganese battery Battery clip 9V battery Battery cover Battery clip Screwdriver Battery cover Page 23 of 36 User Manual Care Bed ECOFIT ULTRA TekVor Care Close the battery cover again Be careful not to damage the washer and avoid over tightening the fastening screws when replacing them 8 Care Cleaning and Disinfection To clean the care bed wipe the bed by hand with a damp cloth Use suitable cleaning and conditioning agents for synthetic furniture Household cleaners without ammonium or scouring agents are also allowed but these should have been dermatologically tested The bed including electrical components is suitable for automated washing systems Solvents and scouring agents are not allowed as these attack and damage the various surfaces of the care bed To disinfect In the homepage of the Robert Koch Institute lt http
15. ckrest and lower leg adjustments are in the horizontal position e The side guard height from the top of the mattress in uncompressed condition must be at least 220 mm If the height is less than 220 mm increase the side guard height with a high side rail kit e The gap between 2 side guard rails or between lower side rail and bed platform must be less than 12 cm e During use ensure that the side guards are level Unplug the mains plug from the socket before moving the care bed and take care to avoid dragging the mains plug across the floor when moving the bed The mains plug must always remain accessible to enable immediate cut off by unpluging the mains plug from the wall socket in case of emergency Page 8 of 36 User Manual Care Bed ECOFIT ULTRA TekVor Care The mains cable must be free and not caught up in anything as it gets carried along when the bed height is adjusted Otherwise the mains cable may be torn out of its strain relief and damaged In addition the mains plug may be pulled out of its socket and electric leads exposed as a result Please check all fixings on your bed at least once a month Pay special attention to side rail components and sleeping platform connections If the mains cable or the mains plug are damaged the relevant part must be replaced This work should only be carried out by the manufacturer or authorised professionals When connecting the mains plug do not use multiple sockets since liquids may pen
16. djustment motor at foot end 13 Coiled cable with SMPS power supply transformer box and main cable with power plug 14 Mattress guide 15 Locating sleeve for patient s lifting pole as an option 16 Aluminium side guard with end caps 17 Release button for side guard lock 18 Side guard channel 19 Castor with mechanical brake O CON NU BW N Fe Page 20 of 36 User Manual Care Bed ECOFIT ULTRA TekVor Care 7 2 7 3 Handset with Locking Function The motorised bed functions can be operated via the handset All functions can be locked with the nurses key Backrest adjustment up down Thigh rest adjustment up down Mattress base height up down adjustment Trendelenburg Antitrendelenburg function Nurses key Nurses key Locking devices 1 2 il Handset hook To avoid damage the handset should always be hung up on the handset hook e g mattress base or side guard when not in use ATTENTION Press only one button at a time as the system could overload and become damaged Locking Function for Handset On the back of the handset there are 2 locking devices 1 2 see pictures on next page All electric adjustment functions can be locked at the same time using the nurses key supplied with locking device 1 When locking device 1 and locking device 2 are both released at the same time the trendelenburg adjustment function of the bed platform is operationa
17. e mains plug from the wall socket in case of emergency The electrical adjustment motors are now ready for use mportant notice Before the bed is put into service please remove the 4 transport clips from above the castors These should be retained and re used if the bed is fitted back on to its transport brackets See picture Page 18 of 36 User Manual Care Bed ECOFIT ULTRA TekVor Care 6 4 Placing into service Make sure that all assembly steps have been carried out according to chapter 6 section 6 1 and 6 2 Do a safety check according to chapter 10 section 10 2 after assembly Clean and disinfect the bed as described in chapter 8 before putting into service and before each further use 6 5 Disassembly of the Care Bed Unplug the mains plug from the socket before disassembly Disassembly of the care bed is carried out in reverse order of assembly Page 19 of 36 User Manual Care Bed ECOFIT ULTRA TekVor Care 7 Description of Functions 7 1 Overview Head end with integrated height adjustment Foot end with integrated height adjustment Electrically adjustable backrest Electrically adjustable thigh rest Mechanically adjustable thigh rest Handset Nurses locking key Electric motor unit for backrest with plug on control unit fitted safe low voltage Electric motor unit for thigh rest 10 Mechanical catch fitting for adjusting thigh rest 11 Electric height adjustment motor at head end 12 Electric height a
18. etrate into these fire hazard and electric shock Before cleaning and disinfection the mains plug must be unplugged and hung up safely Plugs for the handset and the motors which are inserted into the mattress base motor unit must remain plugged in This is necessary to prevent water from penetrating into the motor unit When the bed is stationary the castors must always be in the braked position If the castors are not braked the bed can move when the occupant gets into and out of bed since the occupant uses the bed for support Injury can result if the care bed rolls away In order to move the care bed the brake on all four castors must be released and the mattress base be adjusted to the lowest horizontal position The maximum duty cycle and the safe working load must not be exceeded as otherwise Safe operation cannot be guaranteed please refer to Technical Data The bed must not be used in rooms where there is a risk of explosion The bed must only be taken apart if there is no patient or occupant in it Safety Information for the Operator With the help of this Instruction Manual instruct each user in the safe operation of this care bed before it is put into service for the first time Advise the user of any hazards which may occur if not handled correctly Only persons who have been properly instructed may operate this care bed This also applies for persons who only operate the care bed on a temporary basis According t
19. fely locked into place 7 5 Operation of the Castors All castors on the bed can be braked and must always be in the braked position during normal operation Foot pedal to release the brake Foot pedal to i apply the bine a Ead i er brake Brake released Brake applied using foot pedal ATTENTION The brakes must only be released to move the bed Please also refer to the Safety Information Page 22 of 36 User Manual Care Bed ECOFIT ULTRA TekVor Care 7 6 Electric Emergency Lowering via the I ntegrated 9V Battery 7 6 1 Position and Principle of Operation The power supply unit fitted item 8 Overview on the backrest motor is equipped with a 9V block battery which makes it possible to lower the various electric adjustment functions in the event of a power failure Please note however that this is only possible once per 9V battery as the capacity of the 9V battery is limited After the emergency lowering has been used once the 9V battery must be replaced with a new one Type 6LR61 alkaline manganese battery The 9V battery should however be replaced every 2 years even if it has not been used 7 6 2 Battery Change To replace check or remove before lengthy storage of the 9V battery open the battery compartment on the power supply unit attached to the backrest motor Carry out the battery change as follows ATTENTION Unplug the mains plug Unplug from the low voltage control unit the plug of the connection ca
20. following minimum requirements Visual check Measurement of leakage resistance Measurement of leakage current Functional test Overall evaluation The service life of the care bed depends essentially upon the handling and servicing To guarantee safe operation a visual and functional test including an electrical test must be carried out at least once a year For this purpose proceed according to the technical Safety checklist as per regulation EN 62353 IMPORTANT If you have any doubts about the safety or functioning of the bed or even a part of the bed as a result of the work performed below the bed should under no circumstances be put into service again Contact the supplier or manufacturer in this case Page 25 of 36 User Manual Care Bed ECOFIT ULTRA TekVor Care 10 2 List of Technical Safety Checks according to EN 62353 Care bed Model ECOFIT ULTRA Serial no Onea LOGAUOM IE RR RA Person in charge ss ssseeseseeeeeeees Inspected by O ceea Item Instruction for testing _________________________________ Comment Yes No 1 Isthe general condition OK 2 Are the type plates for the bed and the motors legible __3 Isthe Instruction Manual available to staff 4 Isthe use one for which it was intended and ists __5 No surface damage or corrosion O O o SS o o o __6 Mechanical components and welded joints without faults Z O Z O Z O J o O o y 7 Are all mechanical connecting elemen
21. garded as non compliant with the regulations and is excluded from any liability Page 6 of 36 User Manual Care Bed ECOFIT ULTRA TekVor Care 2 2 3 1 Attention The care bed is not designed for use in hospitals The care bed is not suitable for medical electrical applications which involve intravascular or intercardiac processes with the patient The care bed is not designed for the transport of patients Under certain conditions the care bed can be used for other medical purposes with medical appliances such as antidecubitus mattresses aerators alimentation systems etc In this case all bed functions must be locked out with the nurse key on the handset for safety The medical appliance providers are liable for the compliance of the device with the directives of IEC 60601 1 1 If other electrical devices are used in the bed and to prevent the risk of an electrical shock protective measures and precautions must be established to prevent power cords from being trapped and squeezed in movable parts of the bed Non compliant Use All uses deviating from the intended purpose which may also be hazardous as a result This includes for example e Loading the care bed beyond the safe admissible working load see section 13 1 and identity label on bed frame e Operation of the care bed by patients or occupants who have not been instructed in its use e Use of the care bed for children e Attempting to move the care bed when it is in a br
22. ied In the event of modification of this product without consultation with the manufacturer this declaration of conformity will lose its validity Gummersbach 22 04 2013 Place Date y f EE i gt MS Yeshi Te ape Gesch ftsf hrung Dirk V rwerk Gesch ftsf hrung Page 35 of 36 User Manual TekVor Care Care Bed ECOFIT ULTRA TekVor Care GmbH Fraunhoferstra e 8 51647 Gummersbach Germany Telefon 49 2261 50 186 11 Telefax 49 2261 50 186 20 E Mail info tekvor care com Handelsregister HRB 59353 K ln Ust ID Nr DE251372890 Irrt mer und technische nderungen ohne Vorank ndigung vorbehalten Error and technical modification without prior notice reserved 23 04 2013
23. ing the motor and the mattress base Thigh rest motor Backrest motor situation Final secured state Mattress base Safety bolt Safety lever terminal link fixed in place Please also check the condition of the rubber o rings on the sleeping platform joints if the o rings are damaged or missing they must be replaced DO NOT WASH THE BED WITHOUT INTACT O RINGS FITTED Page 14 of 36 User Manual Care Bed ECOFIT ULTRA TekVor Care Connecting the two halves of the mattress base Now fit the two halves of the mattress base together and secure them using the star knobs provided Check the condition of the rubber o rings here If they are damaged or missing they should be replaced immediately Star knobs M8 4x After assembling the mattress base halves tighten the star knobs Now lay the mattress base on the floor and attach the first of the bed ends to the mattress base To do this apply the brakes on the bed castors by pressing the brake pedal and then release the spring loaded catches see 6 1 at the height adjustable head and foot end panels so that the mattress base can be slotted onto the mounting lugs Foot pedal locked Spring loaded Castor catch Snap the spring loaded catches back into place on both sides Mounting lugs for the mattress base Mattress base The bolt of the spring loaded catch must be securely latched into the hole When securing the spring loaded catches ensure
24. irements for medical products These safety requirements can only be met however if the user satisfies himself of the proper state of the care bed including accessories before using the bed Please observe the Operators of Medical Products Ordinance Medizinprodukte Betreiberverordnung German abbreviation MPBetreibV General Information 2 MPBetreibV Operation and use 5 MPBetreibV Storage of Instruction Manual 89 MPBetreibV Explanation of the Symbols Used Read information with this symbol carefully and urgently follow instructions This information is safety relevant This symbol indicates hazards due to electrical voltage There is mortal danger This symbol indicates general hazards There is danger to life and health C E Conformity mark in accordance with the Medical Device Directive 93 42 EEC The electrical equipment is suitable for automated washing systems Symbol for Protection Class II device shock proof Symbol for type B device according to DIN EN 60601 1 This product must be disposed of in a separate refuse collection in the European Union Do not dispose of as normal domestic waste I PX6 A oe This care bed may only be used indoors ON a Page 5 of 36 User Manual Care Bed ECOFIT ULTRA TekVor Care O 1 2 2 1 C4 IN man A FIN Symbol for direct current Symbol for alternating current R Maximum permissible load L Maximum patient weight Read i
25. l and the platform height adjustment function is locked ATTENTION Trendelenburg function and mattress base height adjustment cannot be operated at the same time The switching positions I and II are testing settings used to check the safety during the annual inspection or after repair work or each time the bed is put into service again Page 21 of 36 User Manual Care Bed ECOFIT ULTRA TekVor Care 2 1 Electric adjustment 1 All electric 2 Trendelenburg 1 All electric adjustment Trendelenburg functions released gt adjustment adjustment functions released adjustment back thigh rest mattress functions locked function released Dac Eu Fost OpSHauiONal function locked base height adjustment NOTE mattress base height functions operational adjustment not operational 7 4 Operation of the Side Guards To use the side guards lift the upper side guard until it locks into place in the highest position To lower the side guard lift the upper side guard and at the same time push the release button for the side guard lock and lower the side guard The side rail guards are designed 2 Pull release button and only to prevent a person falling lower side guard out of the bed under no circumstances should they be climbed or leaned on When lowering the rails take care not 1 Lift the upper side guard to drop them they should be lowered carefully ATTENTION If the side guard is in its high position ensure that it is always sa
26. ls ada alia a a aaa a Page 2 of 36 User Manual Care Bed ECOFIT ULTRA TekVor Care 11 12 13 14 10 4 Measurement of Overall Electrical System eee eee eee eee anne nn 27 GUI ALEE i ne ee Dle ee ee ee 27 Service Life and Disposal u 4u2202020000000000nnnnnnnnnnnnn nn ann nn nn nun ann nn nn nn nn nnn anne 28 Technical Specification 24220220200002002nonn ann nn nun ann nn nn nun nn nn ann nn nn nnn ann nn nn nn 28 13 1 Technical Data Mechanical zessu2002800000n00nn0 000 nen nn nnn RER nun nn nun nn nun RER nn nun nn nen nn nn 28 15 2 Tecnica Data Elec one 28 13 3 Technical Data SurroundingS s ssssssssssssssssrrnnnrnnrnrnrnrnrnrnrnnnrnrnrnrnrnnnnnrnrnrnrnnne 29 15 E D o Ea rece E A s ese ra A E EN e alu tat aa Sf P A 29 13 5 Weights of the Individual Components ssssssssssssnsnenrnnrnrnrnrnrnrnrnrnrnrsrnrnrnnnrnrnnnnne 29 13 0 T Pa een ee ded a A a i 30 13 7 Information about electromagnetic EMISSIONS u2z2222202n02nnnnnnnnnn ano nn nn ann nn nun 31 Declarat on Of CONTONNILV cs bestiei aie oo iesi ae 35 Please read and observe this Instruction Manual before each use In the event that the care bed changes owners please supply this Instruction Manual to the new owner Page 3 of 36 User Manual Care Bed ECOFIT ULTRA TekVor Care Foreword Dear Customer The team from TekVor Care would like to thank you for the confidence you have placed in
27. nstructions Definition of the Groups of Persons I nvolved Operator An operator is any natural or legal person who uses the care bed or on whose instruction it is used e g nursing homes specialised retailers health insurance companies medical Suppliers Users Users are persons who as a result of their vocational training experience or briefing are authorised to operate the care bed or to carry out work on it or are instructed in handling the bed Furthermore the user can recognise and avoid potential dangers and assess the clinical condition of the patient Patient Occupant Persons in need of care handicapped or infirm and occupying a care bed Qualified Personnel Qualified personnel are employees of the operator who as a result of their vocational training or briefing are entitled to deliver assemble disassemble and transport the care bed In addition these persons are instructed in the cleaning and disinfection regulations for the care bed Intended Purpose Use for the Purpose I ntended This care bed is intended for accommodating patients or occupants with body mass 2150 cm to max 170 kg in residential homes nursing homes and in care in the home application environments 3 and 4 and may only be used under the conditions for use described in this Instruction Manual It is used to alleviate or compensate for handicaps or disabilities and to facilitate the working conditions for the carer Any other use shall be re
28. o the Medical Products Act German abbreviation MPG Medizinproduktgesetz care beds are Class I active medical products Please observe your obligations as the operator in accordance with the Operators of Medical Products Ordinance Medizinprodukte Betreiberverordnung German abbreviation MPBetreibV in order to ensure the permanently safe operation of this medical product with no risk of danger to patients users or third parties If the care bed is used on a long term basis checks for proper functioning and for any visible damage must be performed and documented at least once a year There is section 10 2 for this purpose Page 9 of 36 User Manual Care Bed ECOFIT ULTRA TekVor Care 4 3 4 4 4 5 Safety Information for the User Ensure that the operator instructs you in the safe operation of this bed In addition pay particular attention to the general safety information as described in 4 1 Adjustments of the bed must only be carried out by suitably instructed persons or in the presence of an instructed person Make sure that the mattress base has travelled to its lowest position before leaving the patient unattended This will minimise the risk of injury to the patient when getting in or out of bed If there is a suspected fault or damage unplug the mains plug from the socket Clearly mark the care bed as Out of Order and take it immediately out of service After that please inform the operator in charge without delay
29. on from structures objects and persons Field strengths from fixed transmitters such as base stations of mobile telephones and land mobile radios amateur radio AM and FM radio and TV broadcast can not be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey is recommended If the field strength at the location of the care bed exceeds the specified compliance level above then the care bed should be monitored with respect to its normal operation If abnormal performance is observed it may be necessary to take additional measures such as reorienting or relocating the care bed P Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Page 33 of 36 User Manual Care Bed ECOFIT ULTRA TekVor Care Recommended working clearances between portable and mobile RF communications equipment and the care bed The care bed is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or user of the care bed can help to prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the care bed as recommended below according to the maximum output power of the communication device Working clearance according to transmission frequency m PUP ere 150 kHz to 80 MHzat3 80 MHz to 800 MHzat3 800 MHz
30. proper treatment irregular servicing and exceeding the safe working load or the admissible load cycle of the electric motors The care bed must not be disposed of as normal household waste after the end of its service life To ensure that it is disposed of in an environmentally compatible way please get in touch with TekVor Care Technical Specification Technical Data Mechanical Safe working load max admissible load 205 kg Individual loads of the safe working load max weight of patient 170 kg Mattress 20 kg Accessories 15 kg Total 205 kg Safe load patient s lifting pole 80 kg Max weight of patient 170 kg Max mattress height 12 cm Length mattress base Width Upper level of head section foot section Height adjustment of mattress base Backrest adjustment Thigh rest adjustment Foot rest in raised position Mattress base surface Aluminium sideguard rails incl endcaps lowerable on both sides Castors Max castor loading capacity Unloaden weight Operating noise Technical Data Electric Power supply unit LIMOSS Voltage rating Frequency rating 213 5 cm in the case of 200 cm long 104 cm in the case of 90 cm wide mattress base 84 5 cm approx 127 cm continually adjustable electrically from 32 5 75 cm continually adjustable electrically up to approx 70 continually adjustable electrically up to approx 30 mechanically 25 0 in 4 stages Steel slatted base 197 3x9 5x2 8 cm
31. rgy store for electrical emergency lowering in the event of a power failure The energy store is sufficient for one emergency lowering at the most Page 10 of 36 User Manual Care Bed ECOFIT ULTRA TekVor Care 4 6 4 7 4 8 4 9 1 and must then be replaced If the expiry date of the battery has elapsed then it must be replaced immediately Since batteries are subject to self discharging it is recommended that the battery is replaced every two years if not used It must be ensured that itis a type 6LR61 alkaline manganese battery and not any other type Used batteries must be disposed of in an environmentally compatible way Accessories The optional accessories available include a patient s lifting pole of which the safe working load is 80 kg and must not be exceeded The patient s lifting pole may only be used within its admissible adjusting range which is defined by the sleeve on the bed Otherwise the whole bed can tip up and result in serious injury Use only mattresses compatible with the supplied side guard system The dimension between mattress upper surface in uncompressed condition and top edge of the upper side rail must be 22cm minimum If this dimension is less than 22cm a high side rail kit should be fitted In general mattresses of 12 cm height are suitable Electromagnetic Compatibility Regarding their emitted interference and interference resistance the electric motor units comply with the requirements of EN 6060
32. sscersecereueurcesseeuseeersecuueueuueenseeusuerseeauees EROU IAS ee E E ia A 4 9 SeRnviee Life and DISDOSdi aerian sa caii pa a Cafe tf Da i 5 Storageana Transport nu 6 Installation and Commissioning u242n02n0nn0nnonnonnonnn ano nn nno nn nne nn nn nn ananas 6 1 Pre installation inspection eeunsneennnnnennnnnennnnn nun on nun nn nun nn nun nn nn nun nen nn nn nun nn nnn nn nnn an nenn 6 2 Removal from the Transporting Device eee eee eee eee eee eee nana eee 5 3 Assemb OF TING Care Bed ade 64 Placing AMO SEVICE antenne 65 Disassembly Of the Care Bed use elek 7 Description Of FUNCTIONS 4 4022000000000000nnnnnnn ann nun nn nun nn nn eee eee aaa Fed POVENIEW area 7 2 Handset WIth LOCKING FUNGUO irnia sn 72 3 LOCKING FUNCHON TOF Flandser naeh 7 4 Operation ofthe Side Guaids sista eat dea sue n oa ga ie 7 5 OperationrOr the Castors nannten a a ti 7 6 Electric Emergency Lowering via the Integrated 9V Battery cseceeseseeeesereenereees 8 Care Cleaning and DISINFECTION cmec eee eee eee eee eee nenn 9 Trouble SHOOTING siciliene al ile ate in TO STINGING 22 2 an ee eee pi Site Data aaa atuul olane 10 1 PINCHES essen ee 10 2 List of Technical Safety Checks according to EN 62353 eee eee eee nea 10 3 Checking the Initial Fault Safety by means of the Integrated Control Box in the Contents Handset an a et sil de Aa aaa tel RO dak Gl a a te N aaa ta
33. stments should be possible e Set switch on the back of the handset to testing position 2 symbol I1 When operating the adjustment buttons no motorised adjustments should be possible Measurement of Overall Electrical System ATTENTION The measurements described here must only be performed by a qualified electrician or by an electrotechnically trained person using suitable measuring and testing devices The measurements shall include as a minimum the testing of the housing leakage current and the measurement of the isolation resistance The following measured values must be attained Housing leakage current lt 0 2mA Isolation resistance lt 7MQ During testing the corresponding button on the handset must be kept constantly pressed The measurement is to be performed between The control unit and the bed frame The control unit and the handset Guarantee As stated in our Standard Terms and Conditions We provide a manufacturer s warranty of 24 months from the date of purchase Page 27 of 36 User Manual z 13 13 1 13 2 Page 28 of 36 Service Life and Disposal Care Bed ECOFIT ULTRA TekVor Care The service life of our care beds in domestic use is assumed to be approximately 5 years This naturally depends upon the manner of use The carebed is suitable for re use if all measures of section 6 3 and 10 are taken Frequent transportation setting up and adjustment reduce the service life as do im
34. that the bolt locks into place in the hole provided for it Now slot the mattress base into place on the second height adjustable bed end panel at the other end of the bed Do not lock the spring loaded catches on this side just yet because these must remain open until the aluminium side guards have been mounted Now slide the six side guards onto the location bolts of the side guard guides resting the other ends of the side guards on the mattress base at the other end of the bed Page 15 of 36 User Manual Care Bed ECOFIT ULTRA TekVor Care Side guard guide rail Location bolts for the side guards Pull back the bed end panel with mounting lug Slide side guards Lift one corner onto the location of the mattress bolts base slightly Push the end panel back towards the mattress base and place the base onto the mounting lug Fix both the spring loaded catches securely back in place Now with the side guards slotted into place the end panel can be pushed back up to the mattress base and secured with the mounting lug Repeat this procedure on the other side of the bed with the remaining three side guards and then fix the two spring loaded catches securely to the mattress base Now connect the height adjustment motors and the thigh rest adjustment motor to the mains power supply First remove the plug cover by unscrewing the two fixing screws The power supply cables for the height adjustment motors are wound aro
35. tion Ensure that children cannot operate the control system and check if pets are under the bed before operating any of the function Never store anything under the bed If the physical or mental state of the patient requires the handset should be locked on the reverse side of the handset when not in use nurses key See detailed description of the locking operation at section 7 3 it may be advisable to keep the handset out of reach of such a patient to avoid the risk of strangulation with the handset cord Adjustments to the bed must only be carried out by suitably instructed persons or in the presence of an instructed person When the side guards are used the following instructions must be particularly adhered to e Use only approved side guards supplied as option by TekVor Care See suitable dimensions at section 13 1 e Only suitably instructed personnel are allowed to operate the side guards e Side guards must only be adjusted to be either fully up and locked in place or fully down e When operating the adjusting functions the patient s limbs must not protrude beyond the mattress base or touch the side guards e The side rail guards are only designed to prevent a person falling out of the bed under no circumstances should they be climbed or leaned on e When lowering the rails take care not to drop them they should be lowered carefully e The side guards only provide protection against rolling out of the care bed if the ba
36. to 2 5 GHz at transmitter V m V m 3 V m 3 d 2 Vi NP d WP d NP For transmitters not rated in the list above the working clearance can be determined using the equation which belongs to the transmitter where P is the nominal output of the transmitter in watts W according to specifications of the transmitter manufacturer NOTE 1 An additional factor of 10 3 is applied when calculating the recommended working clearance between transmitters in the 80 MHz to 2 5 GHz frequency range in order to reduce the probability that a mobile portable communication device unintentionally brought into the patient area could lead to interference NOTE 2 These guidelines may not apply in all situations Propagation of electromagnetic waves is affected by absorption and reflection from structures objects and persons All parts and data are continually subject to further development and may therefore deviate from the details given Page 34 of 36 User Manual Care Bed ECOFIT ULTRA TekVor Care 14 Declaration of Conformity DECLARATION OF CONFORMITY APPENDIX VII EU DIRECTIVE 93 42 EEC We as company TekVor Care GmbH Fraunhoferstra e 8 D 51647 Gummersbach confirm on our own behalf that the medical product Handicaped accessible bed homecare bed models ECOFIT ULTRA complies with all applicable requirements in Appendix I of the EC directive 93 42 EEC Following compliance evaluation process Appendix VII was appl
37. ts securely fixed O O Z O ooo o To y 8 Mattress base underside undamaged O O O Z o S o O o __9 Can all adjustment options for the bed be operated without hindrance on site 10 Is the mechanism for locking the thigh rest in place in working order o To 11 Are the side guard beams free of any fractures cracks or other damage O J O O Z o o d T Y Do te side gharg beams st securely in Welt anchorage e IiI ao at III RI undamaged and without any signs of wear __15 Functioning of the side guard beams do they safely lock into place Do the side guard beams run smoothly in their guide rails hk le ot 17 Max distance between the side guard beams 12 cm __18 Height of side guards above the mattress at least 22 cm __19 Have castors including locking brake been tested for safe functioning __20 Mains cable connecting cables and plugs without damage __21 Fixture available for safe transportation of mains bug __22 Strain relief of the mains cable and handset securely attached __23 Are all plug in connections securely attached Washers without damage 24 Are cables laid correctly and safely No damage 5 Motor housing and mains plug housing without damage Ee inerea t can aa metre ae 27 _ Functional test of the handset can the buttons be operated properly 28 Functional test of handset locking device On Off working correctly Testing of initial fa
38. ult safety by means of integrated blocking box in handset ee Gs i eG Protective earth conductor resistance does not apply as there is no earth conductor available protective class IT E id EEE FE OK El mai e E OK Patient s leakage current according to IEC Special protection against electric shock w a ae 601 1 Measured value OK Is the safe working load adhered to N FERNEN NIN ee ee ee Overall evaluation of the bed bed OK BE Place Date OO Inspected by Next inspection Signature O m Page 26 of 36 User Manual Care Bed ECOFIT ULTRA TekVor Care 10 3 Checking the Initial Fault Safety by means of the Integrated Control Box in the 10 4 11 Handset To check the safety equipment proceed as follows The switching positions I and II are testing settings used only to check the safety during the annual inspection or after repair work or each time bed Is put into service again Reverse side of handset e Setting switch position 4 padlock symbol open i Move all bed adjustments to a slightly raised position e Setting switch position 3 padlock symbol closed A When operating the adjustment buttons no motorised adjustments should be possible e Set switch on the back of the handset to testing position 1 symbol 1 When operating the adjustment buttons no motorised adju
39. und its housing The backrest motor is supplied already plugged in After you have inserted all the plugs screw the plug cover back onto the power supply unit housing Page 16 of 36 User Manual Care Bed ECOFIT ULTRA TekVor Care Fixing screws of plug cover Unwind the cable of the electric motor Height adjustment motor Thigh rest motor backrest motor handset and power supply are supplied already plugged in Power supply includes UK mains plug cable to Safe Low Voltage Transformer Cable and connectors from Transformer to control box Height adiustment motor Now remove the transportation Height adjustment motor attress base by cutting through the cable ties with a side cutter or a knife Transportation safety device for the thigh rest Transportation safety device for the backrest Page 17 of 36 User Manual Care Bed ECOFIT ULTRA TekVor Care Connecting the care bed to the mains socket Unwind the mains cable wound up under the mattress base Bracket for winding up the mains cable Strain relief for mains Unwind the wound up mains cable cable Lay the coiled cable across the crossbeam from the head or foot end as shown in the picture This reduces the risk that the mains cable is driven over when the bed is moved Always avoid driving over the mains cable Plug the mains plug into the socket The mains plug must always remain accessible to enable immediate cut off by unpluging th
Download Pdf Manuals
Related Search