Home

Optiflex K1 User Manual

1. WARNING Patient hazard It is important that the patient s position is anatomically correct Therefore carefully verify the following settings positions 1 femur length 2 knee joint axis 3 tibia length and leg rotation 4 leg support assemblies Movements must not cause pain or irritation Patients must be fully conscious while being instructed in the use of the CPM device and during the rapy Only the responsible physician or therapist is able and allowed to choose the therapy para meters and protocols to use It is the physician s or therapist s decision whether or not to use the CPM device on a specific patient The patient must be famili ar with the functions of the OPTIFLEX K1 programming unit and the unit must be within easy reach of the patient allow ing him or her to stop therapy if needed Patients unable to ope rate the programming unit e g paralytic patients must never be left unattended during therapy After data storage write the patient s name on the patient chip card The card should only be used for this patient If the patient chip card is used for another patient be sure to delete the previous patient s data from the card first see section 5 2 Programming New Patient Use original chip cards only Any accessories used with OPTIFLEX K1 must first be approved by DJO Do not allow parts of the body or objects such as blankets
2. 28 Surcharges may apply in certain cases to spare parts ordered in low quantities Item Description PartNo Qty 3 patient chip card 0 0034 035 2 marker pen for 0 0031 006 patient chip card DJO GLOBAL DJO LLC A DJO Global Companv 1430 Decision Street Vista CA 92081 8553 USA T 760 727 1280 F 760 734 5608 DJOglobal com 13 7467 A
3. cushions or cables to get caught in the moving parts of the CPM device 1 OPTIFLEX K1 devices with patient chip card only WARNING Shock hazard Strictly observe the following warnings Failure to do so endangers the lives of the patient the user and other persons involved Allow OPTIFLEX K1 to reach room temperature before use If the device has been transported at temperatures below 0 C 30 F leave it to dry at room tem perature for about 2 hours until any condensation has disappeared The OPTIFLEX K1 device must only be operated in dry rooms When disconnecting the device from the power line remove the plug from the wall outlet first before disconnecting the cable from the device When connecting the device to other equipment or when creating a medical system check that the sum of leakage currents will not cause any hazard Please contact DJO if you have questions in this matter Do not use multiple portable socket outlets MPSO to con nect the device to the power line OPTIFLEX K1 must be con nected to a properly installed wall outlet with a non fused earthed wire Before connecting the power cord it must be com pletely unrolled and placed such that it will not get caught by the moving parts of the device Before cleaning and service inter ventions disconnect the device from the power line by removing the power cord from the w
4. 5 minute protocol warmup Starting from the middle position the range of motion is gradually increased toward extension and flexion in steps of 1 5 minute exercise according to programmed settings 5 minute protocol stretch flexion 5 minute protocol EROM repeat flexion 5 minute protocol stretch extensi on 5 minute protocol EROM repeat extension 5 minute exercise according to programmed settings 3 minute protocol cool down The cool down protocol is the warm up protocol of the workout mode reversed Starting from the maximum values the carriage reduces the range of motion by 1 per cycle until the middle position is reached 19 The device switches off when the protocol has been completed The indicated minutes are approximate values Depending on the programmed maximum range of motion the times may vary 9 E Comfort protocol dig ram With the special Comfort function the range of motion is gradually extended until the patient attains the maximum programmed extension and flexion values For this protocol the maximum values are programmed first then the special function is activated and eventually the treatment is started OPTIFLEX K1 Comfort will now complete five cycles in both directions with the maximum programmed values minus 5 Then the range of motion is increased by 1 per cycle in both directions until the programmed limit values are reached Once the
5. 95 dip in UT for 5s lt 5 UT gt 95 dip in for 12 cycle 40 Uy 60 dip in UT for 5 cycle 70 UT 30 dip in UT for 25 cycles 596 UT 9596 dip in UT for 5s Mains power should be that of a typical commercial or hospital environment If the user of the OPTIFLEX K1 device requires continued operation during power mains interruptions it is recommended that the OPTIFLEX K1 device be powered from an uninter ruptible power supply or a battery Power frequency 50 60 Hz magnetic field to IEC 61000 4 8 3 A m 3 A m Power frequency magnetic fields should be at levels characteristics of a typical location in a typical commercial or hospital environment Portable and mobile RF communications equipment are used no closer to any part of the OPTIFLEX K1 device including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter NOTE Ur is the a c mains voltage prior to application of the test level 25 Guidance and Manufacturer s Declaration Electromagnetic Immunity OPTIFLEX K1 is intended for use in the electromagnetic environment specified below It is the responsibility of the customer or user to ensure that the OPTIFLEX K1 device is used in such an environment Immunity test IEC 60601 Compliance level Electromagnetic environ test level ment guidance Recommen
6. Transport Environmental Protection Statement sensara 23 Specifications IEC 60601 1 gt 2 2001 iss isa necari e ceder brani d ERE ETE Sad 24 9 1 Electromagnetic emissions 9 2 Electromagnetic immunity 9 3 Recommended Separation Distances nsara 27 How toireacli us oec odere esae tabe citri cree i 27 Technical ServiG6 ice i neci t o a 28 Tki Technical n eee i a Sr 28 11 2 Shipment 11 3 Spare parts OPTIFLEX K1 Setup Illustrations 1 How to use the CPM device 1 1 Fields of application 1 3 Indications OPTIFLEX K1 is a motor operated Continuous Passive Motion CPM device used to mobilize knee and hip joints Suitable for use in hospitals clinics general practices and rental services it is an important supplement to medical and therapeutic treatment 1 2 Therapy objectives CPM therapy with OPTIFLEX K1 is mainly used to prevent the negative effects of immobilization to allow patients to regain painless mobility of joints at an early stage and to promote healing and achieve a positive functio nal result Other objectives of therapy include improvement of joint metabolism prevention of joint stiffness promotion of the regeneration and healing of cartilage and d
7. and worn parts must immediately be replaced with original spare parts by authorized staff The device does not require additional regular maintenance Fuse replacement WARNING Patient hazard equipment malfunction and damage The replacement of fuses must be referred to specialists as defined in IEC 60364 or other applicable standards e g biomedical technicians electricians electronics installers Fuses used must be T1A fuses 22 6 3 Transport Follow these steps to prepare the OPTIFLEX K1 for transport 1 Adjust the femur length to 49 inches and the tibia length to 42 inches 2 Select the Transport setting 7 from the menu refer to 5 3 for details 3 Push the power switch to turn off the OPTIFLEX K1 4 Disconnect the power cord and the programming unit 5 The device must be stored in its original shipping box for transport DJO cannot be held liable for damage in transit if theoriginal shipping box was not used 6 Set the footplate to a horizontal position 7 Now slide the polystyrene pads onto the OPTIFLEX K1 8 Place the power cord at the bottom of the box before inserting the OPTIFLEX K1 including the polystyrene pads 9 Put the programming unit 20 in the supplied box and store both in the OPTIFLEX K1 box Power cord Programming Unit 7 Environmental protection statement The product descri
8. limit values have been attained the CPM device continues in the programmed range of motion until the end of the therapy session LEVEL 4 E EROM repeat extension G bam The special EROM repeat extension function allows a more efficient exer cise in the last 10 before the set maximum extension value For this protocol the CPM device starts in the middle between the set extension and flexion values It will first move to the programmed flexion value and then to the programmed extension value When the extension value has been reached the carriage reverses 10 toward the fle xion angle and then moves back again to the maximum extension value The move ment through the final 10 is repeated five times at a slow speed At the end of the cycle the carriage will again move to the maximum flexion value and then starts another cycle with five repetitions through the last 10 of the extension angle E EROM repeat flexion AA The special EROM repeat flexion function allows a more efficient exer cise in the last 10 before the set maximum flexion value For this protocol the CPM device starts in the middle between the set extension and flexion values It will first move to the programmed extension value and then to the programmed flexion value When the flexion value has been reached the carriage reverses 10 toward the extension angle and then moves back again to the maximum fl
9. the factory defaults will be restored All stored values will be deleted The carriage will stop in the home position The New Patient home position function selects the following settings extension 25 flexion 35 speed 50 warm up disabled extension pause 0 flexion pause 0 timer continuous operation reverse on load 25 total therapy time 0 stretch extension disabled stretch flexion disabled EROM repeat extension disabled EROM repeat flexion disabled Comfort protocol disabled workout protocol disabled therapy documentation reset OPTIFLEX K1 devices of the Comfort series with patient chip card have a special documentation function which provides a log of all therapy sessions The carriage run times as well as the range of motion of the sessions are recorded The collected data are presented graphically in the form of a coordinate system X axis range of motion Y axis time where the upper curve illustrates the trend of the flexion movement and the lower curve the trend of the extension movement E therapy documentation Service menu Jul For service purposes oniv refer to Service Manual Reminder Vou save the set parameter values bv pressing the STOP kev 6 Care Maintenance Transport 6 1 Care A WARNING Shock hazard Unplug the device from the power line before cleaning Shock ha
10. 3 24 9 2 Electromagnetic immunity Guidance and Manufacturer s Declaration Electromagnetic Immunity OPTIFLEX K1 is intended for use in the electromagnetic environment specified below It is the responsibility of the customer or user to ensure that the OPTIFLEX K1 device is l Immunitv test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD to IEC 61000 4 2 6 kV contact 6 kV contact 8 kV air 6 kV contact 8 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast tran sient burst to IEC 61000 4 5 2 kV for power supply lines 2 kV for power supply lines 1 kV for input output lines 2 kV for power supply lines 1 KV for input out put lines Mains power should be that of a typical commercial or hospital environment Surges to IEC 61000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines to IEC 61000 4 11 lt 5 UT 9596 dip in Ur for 12 cycle 4096 Uy 60 dip in UT for 5 cycle 70 Uy 30 dip in UT for 25 cycles lt 5 UT gt
11. OptiFlex KT Operation Manual Contents OPTIFLEX K1 Setup Illustrations smernnnnznnnnannnnnnannnnnnananannznznanazmznannznznznennznznannenznznnznznazaa 2 1 10 11 How to use the CPM device rine SA nee EIER ERST gea d desi Essa 3 121 Fields OT AD fo fet To n EVERETT TTE TEL IS Ta A 3 1 2 Therapy objectives 1 3 Indications lid GontraindicatiOf is tirer corii Eia er co emet te etsi tenere ctae Fees ci seen ree sd 2d OPTIFLEX K4 description iita A 4 2 1 Description of the device components 2 2 Description of the programming unit 2 3 Explanation of symbols 2 4 Explanation of symbols connections and nameplate Safety information Adjustin the device reote centered EE EH Rx EE SECA KERESE ESENE 11 4 1 Connecting the device performance check 4 2 Adjusting the device to the femur length 4 3 Adapting the leg support assemblies footplate pp 12 Setting the treatment erben Hence SDN RE ERR AIL 13 5 1 General information on programming OPTIFLEX K1 5 2 OPTIFLEX K1 standard models programming 5 3 Treatment value details standard models 5 4 Programming OPTIFLEX K1 Comfort models 5 5 Protocol details Comfort rmodels seccenure niin ttn inne rea tein rh hne GEAR 6 2 Maintenance fuse replacement 6 3
12. The safety state ments are classified as follows A DANGER Indicates an imminent hazard If not avoided this hazard will result in death or serious injury DANGER Explosion hazard OPTIFLEX K1 is not designed for use in areas where an explosion hazard may occur An explosion hazard may result from the use of flammable anesthetics skin clean sing agents and disinfectants N WARNING Indicates a hazard If not avoided this hazard can result in death or serious injury CAUTION Indicates a potential hazard If not avoided this hazard can result in minor personal injury and or product property damage WARNING Patient hazard Only authorized individuals are allowed to operate the OPTIFLEX K1 device Individuals are authorized after receiving training in the operation of the device and reading this operation manual Before using the device the operator must ascertain that it is in correct working order and operating condition In particular the cables and connectors must be checked for signs of damage Damaged parts must be replaced immediately before use Before therapy a test run consisting of several exercise cycles must be completed first without and then with the patient Check that all fixation screws are tightened Stop therapy immediately when you have doubts about the device settings and or the therapy protocol
13. all outlet Liquids must not be allowed to enter the CPM device or the programming unit If liquids have entered into the devices OPTIFLEX K1 must be immedia tely checked by a service techni cian before it can be reused N WARNING Equipment malfunction Magnetic and electrical fields are capable of interfering with the proper performance of the device For this reason make sure that all external devices operated in the vicinity of the CPM device comply with the relevant EMC require ments X ray equipment MRI devices and radio systems are possible sources of interference as they may emit higher levels of electromagnetic radiation Keep the CPM device away from these devices and verify its performance before use Refer repair and maintenance to authorized persons Route all cables below the device frame to either side ensuring that they cannot get caught by the moving parts during operation Inspect OPTIFLEX K1 for damage and loose connections at least once a year Damaged and worn parts must immediately be replaced with original spare parts by authorized staff 10 CAUTION Preventing chafing and pressure sores When your patient is adipose very tall or very short be sure to prevent chafing and pressure sores Place the leg concerned in a mode rate abduction position if deemed appropriate N CAUTION Equipment damage Check that the volta
14. amaged ligaments faster hematoma fluid resorption improved lymph and blood circulation thrombosis and embolism prophylaxis The CPM device is indicated in the treatment of most injuries and diseases of the knee and hip joints as well as in the postoperative treatment after knee and hip joint surgery Examples joint distortion and contusion arthrotomy and arthroscopy proce dures in combination with synovecto my arthrolysis or other intra articular interventions mobilization of joints in anesthetized patients operative treatment of fractures pseudoarthrosis and osteotomy cruciate ligament replacement or reconstruction endoprosthetic implant 1 4 Contraindications Do NOT use OPTIFLEX K1 on patients with acute inflammatory processes in the joints unless on the order of a physician spastic paralysis unstable osteosynthesis 2 OPTIFLEX K1 description The motorized CPM device permits extension and flexion of the knee joint in the range of 10 0 120 and of the hip joint in the range of 0 7 115 These are some of the outstanding OPTIFLEX K1 features anatomically correct setup physiological movements programming unit for precise adjustment of patient specific therapy parameters symbols for easy operation of the programming unit programmed therapy parameters saved to chip card Biocompatibility The parts
15. bed in this operation manual must not be dispose of with unsorted household or municipal waste It requires separate disposal Please contact DJO for information about the possible recycling of the product 8 Specifications Input ratings Current consumption Fuses Protection class Applied part Max load on carriage Dimensions length width height 100 240 V AC 50 60Hz 850 370 mA 2xT1A type B 20 pounds 96 inches 35 inches min 23 inches to max 56 inches Adjustment ranges min max femur range lower leg range weight materials used MPG approx 31 49 inches approx 25 57 inches 11 pounds ABS POM Delrin 100 PUR PA FR4 aluminium stainless steel brass class 2a Standards compliance Certification IEC 60601 1 1988 A1 1991 A2 1995 ANSI UL 60601 1 CAN CSA C22 2 No 601 1 23 Ambient conditions storage transport temperature relative humidity atmospheric pressure 24 C to 60 C 12 F to 140 F 20 to 85 700 hPa to 1060 hPa Ambient conditions operation temperature relative humidity atmospheric pressure 10 C to 40 C 50 F to 104 F 30 to 75 700 hPa to 1060 hPa Subject to change without notice 06 06 9 IEC 60601 1 2 2001 The OPTIFLEX K1 device is subject to particular precautions regarding electro
16. bnormal performance is observed additional measures may be necessary such as reorienting or relocating the OPTIFLEX K1 device b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m 26 9 3 Recommended separation distances between portable and mobile RF communications equipment and the OPTIFLEX K1 device The OPTIFLEX K1 is intended for use in an electromagnetic environment in which radia ted RF disturbances are controlled The customer or the user of the OPTIFLEX K1 device can help prevent electromagnetic interferences by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the OPTIFLEX K1 device as recommended below according to the maximum output power of the communications equipment rated maximum output separation distance according to frequency of transmitter power of transmitter m 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz a 12VP a 12VP la 23 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 12 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 For calcula
17. ded separation distance Conducted RF to 3 Vms 3 Vms IEC 61000 4 6 150 kHz to d 12 P 80 MHz Radiated RF to 3 V m 3 V m d 12V P 80 MHz to IEC 61000 4 3 80 MHz to 800 MHz 2 5 GHz d 23yP 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey 8 is less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol Cp NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the OPTIFLEX K1 device is used exceeds the applicable RF compliance level above the OPTIFLEX K1 device should be observed to verify normal operation If a
18. e Cover the leg support assemblies with disposable tissues when using OPTIFLEX K1 immediately after surgery This helps prevent discoloration CAUTION Patient hazard Ensure that the rotational axes of the CPM device and of the knee joint coincide both in the vertical and in the horizontal plane Fig G Symbol 1 Measurement of the patient s femur length from the greater trochanter to the knee joint cavity Symbol 2 Set the carriage to the home position see 4 1 and adjust it to the measured femur length Symbol 3 Adjust height of calf and thigh support assemblies Adjust the footplate to the height and length of the lower leg 5 Setting the treatment values N WARNING Patient hazard Before therapy a test run consisting of several exercise cycles must be completed without the patient Then repeat the test run with the patient and check that the movement does not cause any pain Note See also 2 2 and 2 3 5 1 General information on programming OPTIFLEX K1 1 You activate the programming mode by briefly pressing the MENU key on the programming unit 2 The various treatment parameters and functions are allocated to three standard model or five Comfort model programming levels four per level To be able to program a parameter you will have to access the corre spond
19. e gentiv stret ched bevond the flexion limit Starting at the middle position the carriage will first move to the pro grammed extension limit and then to the programmed flexion limit Subsequentiv the carriage reverses 5 toward the extension angle and then moves very slowly back again to the programmed flexion limit display gt After that it attempts to stretch the joint another 5 moving even slower than before display gt gt If a high resistance toward the additional 5 is sensed the reverse on load function is automatically acti vated and the carriage moves in the opposite direction This stretch cycle is repeated 10 times After that the carriage moves to the programmed extension limit and restarts the stretch flexion cycle It is not possible to activate the special stretch flexion and stretch extension functions at the same time Note If a flexion pause has been pro grammed the carriage will stop for the pause each time the maximum stretching value is attained E workout protocol With the special workout function a series of special programmed protocols can be completed in one session The program includes the following protocols in a given sequence warmup stretch extension EROM repeat extension stretch flexion EROM repeat flexion and cool down The entire workout protocol takes approx 38 to 40 minutes to com plete Protocol stages
20. elivery and in the New patient mode Note LEVEL 1 equivalent to level 1 of the standard model See 5 3 LEVEL 2 equivalent to level 2 of the standard model See 5 3 LEVEL 3 stretch extension i S With the special stretch extension function the joint will be gently stretched beyond the extension limit Starting at the middle position the carriage will first move to the programmed flexion limit and then to the programmed extension limit 18 Subsequently the carriage reverses 5 toward the flexion angle and then moves very slowly back again to the programmed extension limit display lt After that it attempts to stretch the joint another 5 moving even slower than before display lt lt If a high resistance toward the addi tional 5 is sensed the reverse on load function is automatically acti vated and the carriage moves in the opposite direction This stretch cycle is repeated 10 times After that the carriage moves to the programmed flexion limit and restarts the stretch extension cycle It is not possible to activate the spe cial stretch extension and stretch flexion functions at the same time Note If an extension pause has been programmed the carriage will stop for the pause each time the maxi mum stretching value is attained W stretch flexion gt A With the special stretch flexion function the joint will b
21. exion value The movement through the final 10 is repeated five times at a slow speed At the end of the cycle the carriage will again move to the maximum extension value and then starts another cycle with five repetitions through the last 10 of the flexion angle total therapy time gt OPTIFLEX K1 models without patient chip card The total therapy time is the added sum of operating hours If the device is used by only one patient this time is equivalent to the duration of all the patient s therapy sessions Under menu item total therapy time of OPTIFLEX K1 models with chip card you can view each patient s total therapy time duration of all the patient s therapy sessions Deleting the stored therapy time Press and hold the parameter key for 5 seconds or select the New Patient function 20 LEVEL 5 B transport setting 7 With this function the carriage will move to a position optimally suited for packing the CPM device Set the femur length on 49 inches and the lower leg on 45 inches Select the function and press the START key The carriage moves to the transport position see 6 3 E new patient 0 With this function the CPM device will move to the home position allowing the mechanical settings to be completed Select the function and press the START key The carria ge moves to the home position With OPTIFLEX K1 devices with patient chip card
22. ge and frequency ratings of your local power line are those indicated on the nameplate The leg support element with stands a maximum continuous load of 20 pounds Do not allow any objects such as blankets cushions or cables to get caught in the moving parts of the CPM device Do not expose the OPTIFLEX K1 device to direct sunlight because some of the components may reach inadmissibly high temperatures 4 Adjusting the device 4 1 Connecting the device performance check 1 Connect the power cord to socket 16 of the device and mains plug to a wall outlet with a non fused earthed wire 100 to 240 Volt 50 60 Hz 2 Turn the power switch 18 on 3 Follow these steps to set the carriage to the home position OPTIFLEX K1 without patient chip card Press the MENU key on the programming unit until you reach program level 3 standard model or program level 5 Comfort model Press the New Patient parameter key gt 0 lt Press the START key The CPM device automatically enters the home position OPTIFLEX K1 with patient chip card Initial adjustment for new patients Insert the original patient chip card 21 into the programming unit 20 Press the MENU key on the pro gramming unit until you reach program level 3 standard model or program level 5 Comfort model Press the New Patient parameter key gt 04 Pre
23. gramming levels are selected in the same way as with the standard models Programming levels 1 and 2 are identical with programming levels 1 and 2 of the standard models All special functions are disabled upon delivery and in the New patient mode 17 The following treatment values settings and information can be entered viewed on the programming unit 20 LEVEL 1 extension stretching the knee flexion bending the knee speed warm up protocol A l i GD LEVEL 2 extension pause flexion pause ZA therapy timer reverse on load jo feature for patient safety LEVEL 3 C MENU stretch extension PE lm stretch flexion z4 A workout protocol Comfort protocol LEVEL 4 EROM repeat extension G baum EROM repeat flexion CA total therapy time 2O Continued on next page CD LEVEL 5 transport setting F new patient 0 therapy documentation t Service menu 5 5 Protocol details Comfort models You access the different programming levels by repeated depressions of the MENU key You select the treatment parameters with the corresponding parameter key You change the treatment values with the keys and you enable disable functions by pressing the corresponding parameter key again You save the settings by pressing the STOP key All special functions are disabled upon d
24. ing programming level This is also done with the MENU key With each key press you advance one level The code M1 M2 etc that appears in the middle of the display indicates the programming level 3 You activate the treatment parame ters and functions with the four para meter keys below the display The symbols above the four parameter keys indicate the assigned parame ters and functions 13 This is what happens when you press one of the parameter keys to select a parameter The corresponding symbol appears on the display in a larger format The set value is displayed The symbol above the parameter key appears in reverse video With the keys plus minus you change the displayed value When you press and hold the key the value will change at a higher rate Some of the special functions will only be enabled and disabled This is done by pressing the corresponding parameter key or with the keys Activated parameters are identified with a check mark in the circle next to the symbol Having programmed all parameters press the STOP key to save the values Then press the START key to start therapy Note Refer to sections 5 3 and 5 5 for a description of the parameters To view the set parameter values press the corresponding parameter key However this is only possible when you press the STOP key first To prevent accidental changes of the parameter set
25. ing unit in MENU selection mode selected set angle of the CPM device set extension value set flexion value parameters available for selection corresponding selection keys 2 2 3 Programming unit in programming mode set value of selected function here flexion angle selected function selected parameter here flexion 2 3 Explanation of symbols Standard protocols Comfort protocols 4 extension 4 stretch extension stretching the knee gt stretch flexion AM flexion bending the knee iew workout protocol e speed 3 Comfort protocol 1 l warm up protocol GO bam EROM repeat extension x bem extension pause EROM QA repeat flexion ZA flexion pause therapy timer f EMS control therapy EU t documentation reverse on load AD feature for patient safetv 2 4 Explanation of svmbols gt transport setting connections and nameplate gt O new patient protective earth connection gt total therapy time f tvpe B applied part Sem sevice menu O power switch OFF power switch ON Refer to accompanying documents Do not dispose product with unsorted house hold or municipal waste 3 Safety information Introduction and definitions Safety information Read the safety statements before use of the CPM device
26. justed between 5 and 100 in steps of 5 default setting 50 E warm up protocol 0 gt i During warm up the patient will slowly become used to the set maximum extension and flexion values starting from the middle position The warm up protocol starts in the middle between the two maximum values set for stretching and bending The range of motion increases with each cycle until the programmed maximum values are reached after a total of 15 cycles default setting disabled LEVEL 2 E extension pause ta Pauses occur at the extension limit just before the bending movement starts Pauses can be set to any value between 0 and 59 seconds in steps of 1 second and to values between 1 and 59 minutes in steps of 1 minute default setting no pause E flexion pause AA Pauses occur at the flexion limit just before the stretching movement starts Pauses can be set to any value between 0 and 59 seconds in steps of 1 second and to values between 1 and 59 minutes in steps of 1 minute default setting no pause W therapy timer Default setting is continuous operation of the carriage A clock symbol in the upper right hand corner of the display identifies the continuous mode of operation The clock indicates the elapsed the rapy time In the continuous mode the device must be stopped with the STOP key However you can also select therapy durations of 1 to 59 minutes in steps
27. key The device enters the home position and existing therapy parameters will be deleted With OPTIFLEX K1 devices with patient chip card the factory defaults will be restored All values stored on the chip card will be deleted The carriage will stop in the home position The New Patient function home position selects the following settings extension 25 flexion 35 speed 50 warm up disabled extension pause 0 lexion pause 0 timer continuous operation reverse on load 25 total therapy time 0 E total therapy time gt OPTIFLEX K1 models without patient chip card The total therapy time is the added sum of operating hours If the device is used by only one patient this time is equivalent to the duration of all the patient s therapy sessions Under menu item total therapy time of OPTIFLEX K1 models with chip card you can view each patient s total therapy time duration of all the patient s therapy sessions Deleting the stored therapy time Press and hold the parameter key for 5 seconds or select the New Patient function E Service MENU For service purposes only refer to Service Manual Reminder You save the set parameter values by pressing the STOP key 5 4 Programming OPTIFLEX K1 Comfort models OPTIFLEX K1 devices of the Comfort series offer two more programming levels for additional functions The pro
28. magnetic compatibility EMC The device must be installed and put into service strictly in compliance with the EMC directives put forth in the accompanying documents Portable and mobile RF communication systems may affect the OPTIFLEX K1 device OPTIFLEX K1 should not be used adjacent to or stacked with other equipment If adjacent or stacked use is necessary OPTIFLEX K1 should be observed to verify normal operation in the configuration in which it will be used 9 1 Electromagnetic emissions Guidance and Manufacturer s Declaration Electromagnetic Emissions OPTIFLEX K1 is intended for use in the electromagnetic environment specified below It is the responsibility of the customer or user to ensure that the OPTIFLEX K1 device is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions to Group 1 OPTIFLEX K1 uses RF energy only CISPR 11 for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions to Class B OPTIFLEX K1 is suitable for use in all CISPR 11 establishments including domestic and those directly connected to the public low voltage power supply network that supplies buildings used for domestic pur poses Harmonic emissions to not applicable IEC 61000 3 2 Voltage fluctuations not applicable flicker emissions to IEC 61000 3
29. nsion pause flexion pause RA therapy timer reverse on load feature io for patient safety LEVEL 3 GD transport setting gt new patient 90 total therapy time gt Service menu Note While you adjust the extension flexion values the CPM device will move to the set range This allows you to easily and quickly determine the ROM where the patient does not experience pain Special functions can be programmed and retrieved with OPTIFLEX K1 Comfort devices see sections 5 4 and 5 5 Only OPTIFLEX K1 chip card models allow therapy protocols to be saved to an inserted chip card 5 3 Treatment value details standard models You access the different programming levels by repeated depressions of the MENU key You select the treatment parameters with the corresponding parameter key You change the treatment values with the keys and you enable disable functions by pressing the corresponding parameter key again You save the settings by pressing the STOP key LEVEL 1 Bi extension stretching maximum knee extension 10 degrees maximum hip extension 7 degrees E flexion bending A maximum knee flexion 120 degrees maximum hip flexion 115 degrees 15 Note The programmed value and the value measured at the patient s knee may deviate slightly B speed As The speed can be ad
30. of 1 minute and of 1 to 24 hours in steps of 30 minutes When the time has elapsed the device switches automatically off and stops in the position extension 10 In this case a circle replaces the clock symbol The circle fills as the therapy time progresses E reverse on load feature for patient safety The device automatically starts moving in the opposite direction of the last movement when the patient s resistance load exceeds the set value Adjustable levels for reverse on load feature 1 25 At level 1 very low resistance will cause the device to reverse at level 25 a high resistance is required to initiate the reversal default setting level 25 CAUTION Patient hazard The reverse on load feature is a safety measure to protect the patient in the event of cramps spasms locked joints and similar situations The manufacturer cannot be held liable for misuse of this feature 16 LEVEL 3 W transport setting gt With this function the carriage will move to a position optimally suited for packing the CPM device Set the femur length on 49 inches and the lower leg on 45 inches Select the function and press the START key The carriage moves to the transport position see 6 3 E new patient 04 With this function the CPM device will move to the home position allowing the mechanical settings to be completed Select the func tion and press the START
31. of the OPTIFLEX K1 device that come in contact with the patient during the intended use are designed to fulfill the biocompatibility require ments of the applicable standards 2 1 Description of the device components 1 Thigh length scale femur length scale 2 Thigh length fixation screws femur length 3 Knee hinge 4 Calf length fixation screws tibia length 5 Calf length scale tibia length scale 6 Footplate angle fixation screw 7 Tightening screw for adjusting foot place rotation and to allow removal of foot plate 8 Connection for programming unit 9 Connection for power cord 10 Fuse cap 11 Power switch ON OFF 12 Nameplate 13 Programming unit 14 Patient chip card 15 Compartment for storage of programming unit 1 OPTIFLEX K1 devices with patient chip card only 2 OPTIFLEX K1 Comfort devices only 2 1 Device description continued il a 5 12 8 11 9 2 2 Description of the programming unit 2 2 1 Programming unit in normal mode hu mo patient chip card OptiFlex K1 selected angle of the CPM device selected therapy therapy timer protocol set extension value set flexion value selected direction of motion parameter keys MENU key 4 plus key START key minus key STOP key 1 OPTIFLEX K1 devices with patient chip card only 2 2 2 Programm
32. ss the START key The CPM device automatically enters the home position 11 Adjustment with programmed chip card Insert the original patient chip card 21 into the programming unit 20 Press the START key The CPM device automatically enters the home position Performance check If the programming unit can be operated as described above and OPTIFLEX K1 enters the home positi on for home position values refer to sections 5 3 and 5 5 the device has passed the performance check The device also runs performance checks regularly during operation This is what happens if a problem is identi fied An audio signal sounds The device switches off immediately The message ERR accompanied by a code number e g ERR 5 appears on the display In this situation you may attempt to restart the device by turning the device briefly off and on again with the power switch If the error message persists have the device inspected by a Service technician before using it again 4 2 Adjusting the device to the femur length 1 Measure the length of the patient s thigh femur from the greater trochanter to the lateral knee joint cavity Fig A 2 Set the carriage to the home position see 4 1 3 Set the measured value at the femur scale 3 of the carriage Loosen the two fixation screws 4 Extend the scale 3 to the required length Tighten the fi
33. tings you can lock the keys To do so simul taneously press keys and for approx 3 seconds Press both keys again for approx 3 seconds to unlock 6 Selecting the New Patient function will automatically delete the data on the patient chip card When you have finished program ming the unit and press the STOP key the settings will automatically also be saved to the patient chip card Emergency stop function OPTIFLEX K1 will stop imme diately when any of the keys is pressed during therapy Patient treatment can be resumed by pressing the START key The device will automatically change the direction Patients with a programmed chip card Insert the chip card the patient is not yet positioned on the CPM device Perform the mechanical adjustments of the CPM device femur length etc Position the patient on the CPM device and press the START key to initiate therapy 14 5 2 Programming OPTIFLEX K1 standard models Different programming levels are pro vided to program the OPTIFLEX K1 Standard models You change between levels by pressing the MENU key The display always indicates on which level you are The following treatment values settings and information can be entered viewed on the programming unit 20 LEVEL 1 extension stretching the knee i flexion bending the knee A speed YA warm up protocol l id LEVEL 2 GD exte
34. tion of the recommended separation distance of transmitters in the frequency range from 80 MHz to 2 5 GHz an additional factor of 10 3 was taken into account to reduce the probability of mobile portable communications equipment brought into the patient environment by accident causing any malfunction NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 10 How to reach us Service warranty or repair please contact the selling dealer or your local DJO customer service 27 11 Technical Service 11 1 Technical Hotline Do you have any technical questions Do you need technical service DJO LLC 1430 Decision St Vista CA 92081 USA T 1 800 592 7329 USA T 1 317 406 2209 F 1 317 406 2014 chattgroup com 11 2 Shipment To prevent damage during transport only use the original shipping box These boxes can be obtained from DJO Before packing the CPM device set it to the transport position see chapter 5 11 3 Spare parts Refer to the Service Manual for the most recent list of spare parts When ordering spare parts always specify item description part number quantity serial number of the CPM device Note Refer repairs to authorized specially trained staff DJO offers service training for your personnel
35. xation screws 4 to set the scale to the new length N CAUTION Equipment damage Do not attempt to extend the femur scale beyond the stop 4 3 Adapting the leg support assemblies footplate 1 Set the leg support assemblies and the footplate 1 6 11 to the expected positions before accommodating the patient Loosen fixation screws 8 to adjust the footplate 11 to the length of the patient s lower leg Fig C Loosen clamping lever 13 and adapt the footplate s rotation and height to the patient Fig D Loosen fixation screw 12 and adapt the angle to the patient s foot turn the screw a few revolutions until the footplate can be easily adjusted For short patients you can reverse the footplate s bracket 180 Fig H to adapt the footplate to shorter calves Loosen clamping lever 13 and remove the footplate 11 Loosen the fixation screws 12 Reverse the bracket 180 e Screw the footplate to the bracket and tighten the clamping lever Note When reversing the footplate ensure that the pins below the clamping lever engage with the recesses in the bracket 12 To adjust the height of the support assemblies for calf 1 and thigh 6 loosen clamping levers 2 and 7 Figs E F 2 Place the patient s leg on the carriage and repeat the steps outlined under 1 above to adjust the device to the patient N CAUTION Equipment damag
36. zard equipment damage Liquids must not enter the device or the programming unit OPTIFLEX K1 can be disinfected by wiping down with a disinfectant Thus it complies with the special hygiene standards for medical technical equipment The enclosure and removable leg support assemblies can be cleaned with commonly used disinfectants and mild household detergents Use only a damp cloth to wipe the carriage down CAUTION Equipment damage The plastic material used is not resistant to mineral acids formic acid phenols cresols oxidizing agents and strong organic or inorganic acids with a pH value below 4 Use only clear disinfectants to prevent discoloration of the device Do not expose the CPM device to strong ultraviolet radiation sunlight and fire 21 6 2 Maintenance fuse replacement Check before each use Visually inspect the device for signs of mechanical damage before each use If you detect damage or malfunctions that may impair the safety of the pati ent or of the operator have the device repaired before using it Technical Inspections For safety the devices require regular maintenance To maintain the functional and operational safety check all components for damage and loose connections at least once a year These checks should be performed by persons with adequate training and experience Damaged

Optiflex K1 User Manual

Contents

Download Pdf Manuals

Related Search

Related Contents