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Summary of Contents for DJO Global OptiFlex-K1
- Page 1 Operation Manual...
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Page 3: Table Of Contents
Adjusting the device to the femur length ..............18 Adapting the leg support assemblies/footplate ............19 Setting the Treatment Values ..................... 20 ® General information on programming OptiFlex-K1 – Classic Unit ......20 ® Information about the OptiFlex-K1 therapy parameters – Classic Unit ....21 ®... -
Page 4: Optiflex-K1 Setup Illustrations
® OptiFlex-K1 Setup Illustrations... -
Page 5: How To Use The Cpm Device
1.2 Therapy objectives - mobilization of joints in anesthetized patients ® CPM therapy with OptiFlex-K1 - operative treatment of fractures, is mainly used to prevent the negative effects of immobilization, to allow pseudoarthrosis and osteotomy patients to regain painless mobility of... -
Page 6: Optiflex-K1 ® Description
- programmed therapy parameters saved to chip card Biocompatibility ® The parts 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. -
Page 7: Illustrated Device Components
2.1.1 Illustrated device components 13 12 Chip Card - No. 16... -
Page 8: Description Of The Programming Unit - Classic Unit
2.2 Description of the programming unit – Classic Unit 2.2.1 Programming unit in normal mode selected angle of the CPM device set extension set flexion value value selected direction of motion Extension control Flexion control Pause control Speed control START/STOP key (during operation: LED green, when stopped:... -
Page 9: Programming Unit In Speed Or Pause Programming Mode
2.2.2 Programming unit in speed or pause programming mode set value of selected function selected function (here: speed) -
Page 10: Explanation Of Symbols
2.2.3 Explanation of symbols Symbols on the programming unit: Symbols that may appear in the display Extension Go to start position (stretching the knee) (see Notes in 4.1) Flexion Controls on (bending the knee) programming unit locked (see Notes in 5.1) Speed Controls on Pause (extension... -
Page 11: Description Of The Programming Unit - Standard And Comfort Units
CPM device selected therapy therapy timer protocol set flexion value set extension value selected direction of motion parameter keys MENU key START key “+” (plus) key “-” (minus) key STOP key ® OptiFlex-K1 devices with patient chip card only. -
Page 12: Programming Unit In Menu Selection Mode
2.3.2 Programming unit in MENU selection mode selected MENU level set angle of the CPM device set extension set flexion value value parameters available for selection, corres ponding selection keys 2.3.3 Programming unit in programming mode set value of selected function (here: flexion selected function angle) -
Page 13: Explanation Of Symbols
2.3.4 Explanation of symbols Standard protocols: Comfort protocols: extension stretch extension (stretching the knee) stretch flexion flexion (bending the knee) workout protocol speed Comfort protocol warm up protocol EROM repeat extension extension pause EROM repeat flexion flexion pause EMS control therapy timer therapy documentation... -
Page 14: Explanation Of Symbols (Connections And Nameplate)
(only S# > 20,000) The name next to this factory symbol is the manufacturer (only S# > 20,000) DJO Germany/ORMED GmbH - A DJO Global Company The number next to this symbol is the article reference number (only S# > 20,000) The number next to this symbol is the serial number (only S# >... - Page 15 Council Directive 2002/96/EC concerning Waste Electrical and Electronic Equipment (WEEE). Indicates a requirement not to dispose of WEEE as municipal waste. Contact your local distributor for infor- mation regarding disposal of the unit and accessories. Protect from moisture Listed by Intertek Testing Services NA Inc., for S# <...
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Page 16: Safety Information
Read the safety statements before use of the CPM device. The safety state- DANgER! ments are classified as follows: Explosion hazard – ® OptiFlex-K1 is not designed for use in areas where an explosion DANgER! hazard may occur. An explosion Indicates an imminent hazard. If... - Page 17 - Stabiliy of the physiotherapy unit 3. tibia length and leg rotation must always be ensured while it 4. leg support assemblies ® is in use. The OptiFlex-K1 must - Movements must not cause pain only be set up on surfaces that or irritation.
- Page 18 CPM device or the other persons involved. programming unit. If liquids have ® - Allow OptiFlex-K1 to reach room entered into the devices, temperature before use. If the ®...
- Page 19 - 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 tempera- tures.
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Page 20: Adjusting The Device
4. Adjusting the Device Note: For a better understanding ® OptiFlex-K1 enters the home position of each step, please see also pages (for home position values, refer to 2 and 3. section 4.1), the device has passed the performance check. -
Page 21: Connecting The Device, Performance Check - Standard And Comfort Units
If the programming unit can be 3. Follow these steps to set the carriage operated as described above and to the home position. ® OptiFlex-K1 enters the home positi- on (for home position values, refer to sections 5.3 and 5.5), the device has ®... -
Page 22: Adapting The Leg Support Assemblies/Footplate
Cover the leg support assemblies - Tighten the fixation screws (2) to with disposable tissues when ® set the scale to the new length. using OptiFlex-K1 immediately after surgery. This helps prevent discoloration. CAUTION! Equipment damage – Do not attempt to extend the CAUTION! femur scale beyond the stop. -
Page 23: Setting The Treatment Values
3. Subsequently press the START/ STOP key to start therapy. 5.1 general information on programming Note! ® OptiFlex-K1 – Refer to sections 5.2 for a description of the parameters. Classic Unit - To prevent accidental changes of the parameter settings, lock the programming unit by 1. -
Page 24: Information About The Optiflex-K1
5.2 I nformation about The value entered applies to both extension and flexion pause. ® the OptiFlex-K1 therapy parameters Pauses can be set to any value bet- ween 0 and 59 seconds in steps of – Classic Unit 1 second, and to values between 1 and 59 minutes in steps of 1 minute. -
Page 25: General Information Programming Optiflex-K1
5.3 general information parameter key or with the +/- keys. Activated parameters are identified on programming with a check mark in the circle next ® OptiFlex-K1 – to the symbol. Standard and Comfort Units 5. Having programmed all parameters, press the STOP key to save the values. -
Page 26: Programming Optiflex-K1 - Standard Unit
- To view the set parameter values, press the corresponding Different programming levels are provided parameter key. However, this is ® to program the OptiFlex-K1 Standard only possible when you press the STOP key first. models. You change between levels by pressing - To prevent accidental changes of the MENU key. -
Page 27: Treatment Value Details - Standard Unit
OptiFlex-K1 Comfort default setting: 50% devices (see sections 5.6 and 5.7). ® - Only OptiFlex-K1 chip card models allow therapy protocols to n warm up protocol be saved to an inserted chip card. During warm up, the patient will... - Page 28 ® With OptiFlex-K1 devices with pati- The device automatically starts ent chip card, the factory defaults will moving in the opposite direction of be restored. All values stored on the the last movement when the patient‘s...
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Page 29: Programming Optiflex-K1 - Comfort Unit
- extension Under menu item “total therapy time” (stretching the knee) ® of OptiFlex-K1 models with chip - flexion (bending the knee) card you can view each patient‘s total therapy time (duration of all the patient‘s therapy sessions). -
Page 30: Protocol Details - Comfort Unit
Subsequently the carriage reverses 5 ° toward the flexion angle and then MENU LEVEL 5: moves very slowly back again to the programmed extension limit (display - transport setting <=). After that it attempts to stretch the joint another 5 °, moving even - new patient slower than before (display <<). - Page 31 ® OptiFlex-K1 Comfort will now com- plete five cycles in both directions The program includes the following with the maximum programmed values protocols in a given sequence: minus 5 °.
- Page 32 ® With OptiFlex-K1 devices with another cycle with five repetitions patient chip card, the factory def- through the last 10 ° of the flexion aults will be restored.
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Page 33: Care, Maintenance, Transport
Liquids must not enter the device or the programming unit. CAUTION! Equipment damage – ® - OptiFlex-K1 can be disinfected by wiping down with a disinfectant. Thus, - The plastic material used is not it complies with the special hygiene... -
Page 34: Maintenance (Fuse Replacement)
6. Set the footplate to a horizontal position. DJO Global will make all documents 7. Now slide the polystyrene pads ® required for servicing, such as circuit onto the OptiFlex-K1 diagrams, parts lists, descriptions 8. -
Page 35: Environmental Protection Statement
It requires separate disposal. Please contact DJO for information about the possible recycling of the product. The service life of the product as well as the supplied parts and accessories is 6 years minimum. 8. Specifications OptiFlex-K1 ® Model: Standards compliance: IEC 60601-1:1988+A1:1991+A2:1995 Input ratings: 100 –... -
Page 36: Electromagnetic Emissions
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions is intended for use in the electromagnetic environment specified below. It is ® OptiFlex-K1 ® 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 –... -
Page 37: Electromagnetic Immunity
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity is intended for use in the electromagnetic environment specified below. ® OptiFlex-K1 ® 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-test... - Page 38 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity is intended for use in the electromagnetic environment specified below. It is ® OptiFlex-K1 ® the responsibility of the customer or user to ensure that the OptiFlex-K1 device is used in such an environment. Immunity test IEC 60601...
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Page 39: Recommended Separation Distances
® The OptiFlex-K1 is intended for use in an electromagnetic environment in which radiated ® 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 ®... -
Page 40: Technical Service
11. Technical Service Surcharges may apply in certain cases 11.1 Technical hotline to spare parts ordered in low quantities. 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... - Page 41 Notes...
- Page 42 Notes...
- Page 44 DJO, LLC A DJO Global Company 1430 Decision Street Vista, CA 92081-8553 • USA T 760.727.1280 • F 760.734.5608 DJOglobal.com MOT-304-OPTIFLEX-Rev.04-02/2014...
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