Performa Manual
Contents
1. 1 24P IEC 61000 4 6 3 V m 3 V m d 1 24 P from 80 MHz to 800 MHz Radiated RF interference from 80 MHz to 2 5 GHz IEC 61000 4 3 d 23 VP from 800 MHz to 2 5 GHz where P is the emitter s maximum output power characteristic in watts W according to the emitter s manufacturer and d is the recommended separation distance in metres m The field intensities of fixed RF emitters determined by an on site electromagnetic investigations should be below the compliance level in each frequency range There may be interference near appliances bearing the following symbol gt NOTE 1 At 80 and 800 MHz the highest frequency range is applicable NOTE 2 These directives cannot be applied in every situation Electromagnetic propagation is affected by absorption and reflection by structures objects and people a The field intensity of fixed emitters such as base stations for radio telephones cellular cordless and land mobile radios amateur radio AM FM radio broadcasts and TV broadcasts cannot be predicted exactly in theory To evaluate the electromagnetic environment due to fixed RF emitters an on site electromagnetic investigation should be considered If the field intensity measured where the KINETEC PERFORMA splint is used exceeds the aforementioned applicable RF compliance level the KINETEC PERFORMA splint should be monitored to check that it is working normally If abnormal results are observed additional measures may be neces2. compatibility of medical devices KINETEC Performa complies with the standards of Directives Machine n 2006 42 CE Description The KINETEC Performa machine consists of the following components 1 Lower limb support 2 Thigh support 3 Foot support 4 Hand control 5 e Thigh support setting lock 6 e Lower limb support setting lock 7 Foot support positioning setting lock 8 Transport handle 9 ON OFF switch and fuses 10 Liquid crystal display 11 Increase decrease keys 12 e EXTENSION setting key 13 FLEXION setting key 14 STOP key 15 START key 16 PAUSE key 17 SPEED key 18 FORCE key 19 TIMER key 20 Reading or selecting SYNCHRO STIMULATOR please request the instruction sheet from your KINETEC distributor Display Details A 3 character area showing the extension limit Be 3 character area showing the flexion limit C 8 character area showing various messages RUN STOP EXT FLEX SPEED FORCE PAUSE etc D e 3 character area showing the real time angle of the knee this value changes in line with the movement Performa EN 2 10 Electrical connection SAFETY FIRST The KINETEC Performa is type B class devices Before connecting the device to the power supply check that the mains voltage matches that shown on the identification plate 100 240 V 50 60HZz Connect the power supply cable 21 IMPORTANT Check that
3. 31 with the axis rotation 32 of the KINETEC Performa machine and the axis of the patient s knee 33 with the axis rotation 34 of the KINETEC Performa machine Options Trolley for all CPM Cart for bed use Part number to order 4655001053 Part number to order 4665003297 Performa adaptation plate Part number to order 4665003560 Performa EN 6 10 Maintenance After 2 000 hours of operation the KINETEC Performa requires lubrication and maintenance operations lubrication of the joints pointer stops and ball screws The need for maintenance is indicated by display of the message SERVICE when the system is switched on Despite that warning you can continue to use your KINETEC Performa by pressing START but you should contact your nearest KINETEC technician to have the maintenance operations conducted as soon as possible When the machine is no longer in working condition please return it to us together with its accessories for destruction Troubleshooting A spare parts list and technical catalog are available to you on request from your KINETEC distributor If after connecting the power supply cable to the power supply and switching on the KINETEC Performa e The display does not indicate any information Check that the electrical socket is live using another device Replace the fuse s 35 of the connector with fuses of the same type and calibre 2 fuses T 500 mA 250V 6 3x32mm KINETEC o
4. Performa Manual Definition The KINETEC Performa is a PASSIVE Knee mobilisation device enabling the extension and flexion movement from de 3 130 Indications e Knee replacement surgery e Fractures patellar tibia plateau femoral e Arthrolysis e Hip surgery including hip replacement hip pinning osteotomy e Ligament repairs e Arthroscopic surgery menisectomies patellectomies e Burns joints sepsis Clinical Benefits e Breaks the cycle of trauma inflammation and the loss of range of motion e Prevents joint stiffness e Speeds the recovery of post operative range of motion e Maintains the quality of the joint surface e Reduces pain and oedema e Promotes joint cartilage healing e Reduces hospitalization time e Reduces the need for pain medication e Provides immediate post operative continuous passive motion e Digital ROM readout on the patient hand control for positive reinforcement e Maintains desired positions for stretching and muscular rest Contraindications Bone Cancer warped joint surfaces spastic paralysies unstable fractures uncontrolled infection The machine is not suitable for patients over 2 06 m or under 1 12m Warning and Safety instructions Warning The physician physiotherapist defines the protocol and ensures that it is correctly implemented adjustments session time and frequency of use Warning Run a cycle with the device unloaded before installing the patient on th
5. ause O to 900 seconds 15minutes e Timer O to 24h00 DAILY COUNTER function RESET TIME With the splint stopped simultaneously press the EXTENSION and FLEXIONI buttons This function allows you to see how long the appliance has been operating since it was last reset Press the button twice to reset the counter or to exit without resetting it MANUAL MODE Start of a session This function allows you to define and save the maximum limits supported by the patient This mode is generally used at the start of a session With the Kinetec Performa on STOP P keep the following buttons pressed for at least 3 seconds to define the extension limit e to define the flexion limit and then the movement limit buttons to memorise the actual angle reached BY PASSING MODE During a session This function allows you to define and save the maximum limits supported by the patient This mode is generally used during a session With the Kinetec Performa on RUN keep the following buttons pressed for at least 3 seconds e to exceed the programmed limit and define a new extension limit e to exceed the programmed limit and define a new flexion limit and then the movement limit buttons to memorise the actual angle reached Performa EN 4 10 Using the Plastic Comfort Case kit Specially designed to improve comfort and hygiene for the patient The Plastic Comfort Cas
6. e is applicable NOTE 2 These directives cannot be applied in every situation Electromagnetic propagation is affected by absorption and reflection by structures objects and people Performa EN 10 10
7. e machine Warning For optimum safety always give the hand control to the patient before starting the system The patient must know the start stop reverse function on the hand control see page 3 Warning To avoid the parameters being changed lock the machine s hand control before giving it to the patient Warning Danger risk of explosion Do not use the machine with anaesthetic gas or in an environment that is rich in oxygen Warning To avoid all risks of electric shock the machine should only be connected to a power supply that has protective earthing Warning Before using this machine always check that the electrical socket is in good condition and is suitable for the splint power supply cord Only use the original cable supplied with the machine Check that the cables remain free around the device so that they do not get damaged Warning Before using this machine always check that the machine is not damaged in particular the protective housings and the power cord Warning In case of electromagnetic interference with other devices move the device Warning Please do not touch the moving parts while the unit is running pinching risk Warning Modifying the machine in any way is strictly forbidden Performa EN 1 10 Compliance KINETEC Performa complies with the standards of Directive 93 42 EEC and bears the CE mark KINETEC Performa complies with the standards in force IEC 601 1 2 concerning the electromagnetic
8. es come with straps to precisely and quickly adjust to the patient s leg dimensions CLEANING To ensure optimal hygiene clean the supports after each patient use Use a DISINFECTANT product alcohol free or lt 5 alcohol solution in spray plastic cases and metal components Replacement parts 23 4670024048 Complete foot support 24 4635010561 Foot support strap kit 24 25 4670023686 Tibia case with straps 26 4670023694 Femur case with straps 27 4670016657 Thigh bar 28 4645000841 Single strap Part number to order a complete kit 4670017655 Kin zy 4 gu is j Use of the Kinetec Patient Pad Kit The KINETEC Patient Pad Kit is designed for rapid fitting optimal hygiene and maximum patient comfort Position the straps on the leg and thigh cradles make sure that the self adhesive parts are visible Place the sponge side next to the skin FOR OPTIMAL HYGIENE A NEW SET OF PADS SHOULD BE USED FOR EACH PATIENT Each cover is provided with a label to record the patient s name CLEANING Sterilization of the pads if necessary Sterilized at 134 C during 18 minutes Disinfecting of the pads Washing at 30 C with use of a disinfecting solution during the rising cycle Example of products that can be used Solution Baclinge at 0 125 or Souplanios at 0 125 from ANIOS Laboratory A complete list of distributors in your country is available on request The KINETEC Performa is delivered with a complete set Componen
9. everse function operated Double Blocage Simultaneously press the PAUSE EXT and PAUSE FLEX keys to lock the hand control The display reads LOCK you cannot change the parameters if you try the display reads VERROU SOFTI To unlock the hand control simultaneously press the same keys The display reads UNLOCK We recommend that you lock the hand control when you give it to the patient Note The hand control locking is preserved when you switch the unit ON OFF Performa EN 3 10 Setting the movement parameters Select the parameter to be set Extension limit flexion limit soeed pause at the extension or flexion limit force or timer the setting to change will flash Press the or buttons to modify the setting the new setting will flash To confirm the new setting press another function button or wait approximately 5 seconds for automatic confirmation Movement parameters can be set either when the machine is stopped or when it is in operation At the end of the session the display reads TIMER OOHOOMIN and the unit stops at an average angle use Press or to select a new session time Possible values for each parameter Possible values e Extension limit 3 to 125 e Flexion limit 2 to 130 e Speed 1 to 7 from 50 to 220 per minute e Force 1 to 6 e Extension pause O to 900 seconds 15minutes e Flexion p
10. he operating instructions Temperature Limit during storage or transport Alternative current Right way up when box is stored Fragile Keep dry during storage or transport Contains electric and electronic components not to throw in the dustbins of household refuse Hand control unlock Hand control lock Pause Pause Timer POTE O SYNCHRO STIMULATOR Plug for synchro stimulator Warranty The KINETEC warranty is strictly limited to the replacement free of charge or repair in the plant of the component or components found to be defective KINETEC guarantees its joint passive mobilization systems for 2 years against all defects of manufacture from the date of purchase by the consumer KINETEC is the only organization able to assess the application of the warranty to its systems The warranty will be considered null and void if the device has been used abnormally or under conditions of use other than those indicated in the user s manual The warranty will also be considered null and void in the event of deterioration or an accident due to negligence inappropriate surveillance or inappropriate maintenance or due to transformation of the equipment or an attempt to repair the equipment Performa 8 10 GUIDANCE AND MANUFACTURER S DECLARATION Electromagnetic emissions The KINETEC Performa is intended for use in the electromagnetic environment specified bel
11. ic sites for recycling b KINETEC PATIENT PAD KIT Clean with disinfectant then to give it to the specific sites for recycling c Unit It contains electronic components cables aluminium steel and plastic parts When the splint is not operational any more to dismount and separate in groups from materials and to give them to correct unit of recycling or return the machine to Kinetec for destruction Performa EN 7 10 Technical specifications Product Weight 15Kg Splint dimensions 109cm x 33cm x 33cm Angular limits 3 to 130 Speed from 50 to 220 per minute Patient height Maximum Weight 135kg Patient sizing 112 to 206 cm Full leg 58 to 110 cm Tibia 32 to 60 cm Femur 26 to 50 cm Sound pressure lt 70dB Electricity Power supply 100 240 V Frequency 50 60Hz Power consumption 50VA Device of type B class IP 20 Fuse T 500mA 250V 6 3x32mm KINETEC order 4610002400 Environment Storage transport conditions Operatin g conditions Symbols used Temperature 40 to 70 C 40 to 160 F Relative humidity up to 90 Room temperature 10 to 40 C 50 to 105 F Relative humidity up to 80 TYPE B device protection against electric shocks Speed Flexion limit Warning or CAUTION check accompanying documentation Force Extension limit STOP power off ON power on Increase Decrease I Start movement Stop movement Refer to t
12. lint must be used next to other appliances the splint should be under constant supervision to check that it is working normally in the given configuration Electromagnetic immunity The KINETEC Performa is intended for use in the electromagnetic environment specified below The customer or the user of the KINETEC Performa should ensure that it is used in such an environment Immunity test EE Compliance level Electromagnetic environment guidance 2 kV 4 kV 6 kV 2 kV 4 kV 6 kV Electrostatic discharge contact contact Floors should be wood concrete or ceramic tile If floors ESD are covered with synthetic material the relative IEC 61000 4 2 2 kV 4 kV 8 kV 2 kV 4 kV 8 kV humidity should be at least 30 air air 2 kV for power supply ei fast transient 2 kV for power supply lines Wes Mains power quality shouid be that of atypical IEC 61000 4 4 1 kV for input output lines EEN SOE CIEE hospitalenyironnmert 1 kV between lines 1 kV between lines Surge Mains power quality should be that of a typical IEC 61000 4 5 2 kV between line and 2 kV between line and commercial or hospital environment earth earth lt 5 Ur lt 5 Ur gt 95 dip in Ur gt 95 dip in Ur for 0 5 cycle for 0 5 cycle 40 Ur 40 ur Mains power quality should be that of a typical Voltage dips and voltage i iB Ur 60 Aip in Ui commercial or hospital environment If the user of the ses or 5 cycles fo
13. ow The customer or the user of the KINETEC Performa should ensure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance 7 ap The KINETEC Performa uses RF energy only for its internal function Radio electric Frequency emissions ae Group 1 Therefore its RF emissions are very low and are not likely to Cause any CISPR 11 interference in nearby electronic equipment Radio electric Frequency emissions Class B CISPR 11 The KINETEC Performa is suitable for use in all establishments including Harmonic emissions Non domestic establishments and those directly connected to the public low IEC 61000 3 2 Applicable voltage power supply network that supplies buildings used for domestic Voltage fluctuations Flicker emissions Complies purposes IEC 61000 3 3 Electromedical appliances require special precautions concerning EMC They therefore need to be installed and commissioned following the EMC information supplied Electromedical appliances may be affected by mobile and portable RF communication devices WARNING using cables and accessories other than those specified except for those sold by Kinetec as replacements for internal components may lead to an increase in emissions or a decrease in the KINETEC PERFORMA splint s immunity WARNING the KINETEC PERFORMA splint should not be used next to other appliances If the KINETEC PERFORMA sp
14. r 5 cycles 3 variations on power KINETEC Performa requires continued operation supply input lines 70 Ur 70 Ur during power supply interruptions it is recommended CEI 61000 4 11 eat aoe that the KINETEC Performa be powered from an 30 dip in Ur 30 dip in Ur uninterruptible power supply or a battery for 25 cycles for 25 cycles lt 5 Ur lt 5 Ur gt 95 dip in Ur gt 95 dip in Ur for 5 seconds for 5 seconds Power frequency 50 60 Power frequency magnetic fields should be at levels Hz magnetic field 3A m 3A m characteristic of a typical location in a typical IEC 61000 4 8 commercial or hospital environment NOTE Uris the a c mains voltage prior to application of the test level Performa EN 9 10 GUIDANCE AND MANUFACTURER S DECLARATION Electromagnetic emissions The KINETEC Performa is intended for use in the electromagnetic environment specified below The customer or the user of the KINETEC Performa should ensure that it is used in such an environment IEC 60601 Compliance Test level level Immunity test Electromagnetic environment guidance Mobile and portable RF communication devices should not be used closer to any part of the KINETEC PERFORMA splint including its cables than the recommended separation distance calculated based on the equation applicable to the emitter s frequency Recommended separation distance Conducted RF interference foim ri 80 MHz 3V d
15. rder 4610002400 If the display still does not indicate any information contact your nearest KINETEC technician e Your KINETEC Performa does not work and the display indicates 50 STOP 25 115 Press START again Your KINETEC Performa still does not function Contact your nearest KINETEC technician e Your KINETEC Performa does not function and the display indicates SERVICE D1 angle measurement function failure Or SERVICE D2 failure during motion Or SERVICE D3 failure of motor direction Contact your nearest KINETEC technician if the same message is displayed after having switched the device off then on and started it by pressing START Cleaning Avant tout mettre l appareil HORS TENSION en d connectant le cordon secteur Nous recommandons un nettoyage entre chaque patient Le nettoyage est r alis dans les conditions environnementales sp cifi es dans le paragraphe Caract ristiques techniques ci apr s Utiliser un produit de DESINFECTION solution sans alcool ou lt 5 d alcool par pulv risation des SURFACES coques plastiques et l ments m talliques Afin d assurer une hygi ne optimale il est conseill de nettoyer les habillages apr s chaque patient tous les consommables de l appareil peuvent tre jet s sans danger Elimination and recycling ae Packing Packing must be separated from the components plastic and paper cardboard and given to the specif
16. sary such as reorienting or repositioning the KINETEC PERFORMA splint b Over the frequency range from 150 kHz to 80MH7z field intensities should be less than 3V m Recommended separation distances between mobile and portable RF communication devices and the KINETEC PERFORMA unit The KINETEC PERFORMA splint is designed to be used in an electromagnetic environment in which radiated RF interference is controlled The KINETEC PERFORMA splint customer or user can help prevent electromagnetic interference by maintaining a minimum distance between mobile and portable RF communication devices emitters and the KINETEC PERFORMA splint as recommended below according to the communication device s maximum output power Separation distance according to the emitter s frequency Maximum assigned output m power for the emitter from 150 kHz to 80 MHz from 150 kHz to 80 MHz from 150 kHz to 80 MHz d 12VP d 12VP d 12VP 0 01 0 12 0 12 0 12 0 1 0 38 0 38 0 38 1 1 2 1 2 1 2 10 3 8 3 8 3 8 100 12 12 12 For emitters whose assigned maximum emitted power is not given above the recommended separation distance d in metres m can be estimated using the equation applicable to the emitter frequency where P is the emitter s maximum emission power characteristic in watts W according to the latter s manufacturer NOTE 1 At 80 and 800 MHz the separation distance for the highest frequency rang
17. the electrical socket is in good condition and is suitable for the splint power supply cord The latter complies with current standards and has a grounding socket The plug may be connected to any standard socket The socket must however have a grounded pin To connect the power supply only use the original cable supplied with the machine Check that the cables remain free around the device so that they do not get damaged Check that the machine is not damaged in particular the protective housings Starting the unit Switch on the unit 9 The display comes on and then the display shows KINETEC PERFORMA Your KINETEC Performa is ready to be used START STOP REVERSE function As with all KINETEC systems KINETEC Performa is equipped with a START STOP REVERSE function Press the STOPI key of the hand control The movement stops Press the START key of the hand control The movement starts in the opposite direction Caution For optimum safety always give the hand control to the patient before starting the system Procedure to stop the machine To stop the machine s movement Press the STOP button To switch power off press the ON OFF switch 9 Locking the hand control setting The hand control allows the patient to control the machine as appropriate UNLOCKED POSITION 22 adjustments are possible LOCKED POSITION 22 the OPERATIONAL settings can be read and the Start Stop R
18. ts 4 straps 4650001107 1 foot support 4650001131 1 cover 4650001090 Part number to order the complete set 4650001058 Performa EN 5 10 ADJUSTING FOR RIGHT OR LEFT LEG The KINETEC Performa is designed anatomically Because of this the thigh slide 29 should always be placed on the same side as the leg to be mobilised To change legs proceed as follows Withdraw the hip bar 29 from thigh support bar B 2 Slide the hip bar into the thigh support bar on the other side of the exerciser and attach the hip bar on the thigh support a index confirms the good position IMPORTANT if the knobs 5 are not tighten the device stops and the display reads SERVICE D2 l Therefore it is possible to move MANUALLY the machine by depressing the key _ U or for more than 3 seconds Setting up the patient Place the KINETEC Performa machine in a position that will be comfortable for the patient Measure in cm or inches the length of the patient s femur L adjust the thigh support to this measurement using knobs 5 To install the patient on the KINETEC Performa machine Push the foot plate 3 up to the patient and tighten the knobs 6 Adjust the plantar flexion 40 or the dorsal flexion 30 of the foot with the knobs 7 Adjust the internal 30 or external 30 flexion of the foot with the knob 30 IMPORTANT Adjust the axis of the patient s hip
Download Pdf Manuals
Related Search