Operation Manual
44 Pages
Preview
Page 1
Operation Manual
Contents OptiFlex-K1® Setup Illustrations... 2 1.
How to Use the CPM Device... 3 1.1 1.2 1.3 1.4
2.
Fields of application... 3 Therapy objectives... 3 Indications... 3 Contraindications... 3
OptiFlex-K1® Description... 4 2.1 Description of the device components... 4 2.1.1 Illustrated device components... 5 2.2 Description of the programming unit – Classic Unit... 6 2.2.1 Programming unit in normal mode... 6 2.2.2 Programming unit in speed or pause programming mode ... 7 2.2.3 Explanation of symbols... 8 2.3 Description of the programming unit – Standard and Comfort Units 2.3.1 Programming unit in normal mode... 9 2.3.2 Programming unit in MENU selection mode... 10 2.3.3 Programming unit in programming mode... 10 2.3.4 Explanation of symbols... 11 2.4 Explanation of symbols (connections and nameplate) ... 12
3. 4.
Safety Information... 14 Adjusting the Device ... 17 4.1 4.2 4.3 4.4
5.
Setting the Treatment Values... 20 5.1 5.2 5.3 5.4 5.5 5.6 5.7
6.
Connecting the device, performance check – Classic Unit... 17 Connecting the device, performance check – Standard and Comfort Units... 18 Adjusting the device to the femur length ... 18 Adapting the leg support assemblies/footplate... 19 General information on programming OptiFlex-K1® – Classic Unit... 20 Information about the OptiFlex-K1® therapy parameters – Classic Unit... 21 General Information programming OptiFlex-K1® – Standard and Comfort Units... 22 Programming OptiFlex-K1® – Standard Unit... 23 Treatment value details – Standard Unit... 24 Programming OptiFlex-K1® – Comfort Unit... 26 Protocol details – Comfort Unit... 27
Care, Maintenance, Transport... 30 6.1 6.2 6.3
Care... 30 Maintenance (fuse replacement) ... 31 Transport ... 31
7.
Environmental Protection Statement... 32
8.
Specifications ... 32
9.
IEC 60601-1-2:2007 and IEC 60601-1-11:2010... 33 9.1 9.2 9.3
Electromagnetic emissions... 33 Electromagnetic immunity ... 34 Recommended separation distances... 36
10. How To Reach Us... 36 11. Technical Service... 37 11.1 Technical hotline... 37 11.2 Shipment... 37 11.3 Spare parts... 37
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OptiFlex-K1® Setup Illustrations
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A
B
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D
E
F
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.
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:
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 functional result. Other objectives of therapy include: - improvement of joint metabolism - prevention of joint stiffness - promotion of the regeneration and healing of cartilage and damaged ligaments
- joint distortion and contusion - arthrotomy and arthroscopy procedures in combination with synovectomy, 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:
- faster hematoma/fluid resorption
- acute inflammatory processes in the joints, unless on the order of a physician
- improved lymph and blood circulation
- spastic paralysis
- thrombosis and embolism prophylaxis
- unstable osteosynthesis
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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°.
11. Fuse cap
These are some of the outstanding OptiFlex-K1® features:
14. Programming unit – Classic and Standard/Comfort
- anatomically correct setup
15. Compartment for storage of programming unit
- 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 of the OptiFlex-K1® device that come in contact with the patient during the intended use, are designed to fulfill the biocompatibility requirements of the applicable standards.
2.1 D escription 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 7. Footplate angle fixation screw 8. Tightening screw for adjusting foot place rotation and to allow removal of foot plate. 9. Connection for programming unit 10. Connection for power cord 4
12. Power switch (ON/OFF) 13. Nameplate
16. Patient chip card1 1
OptiFlex-K1® devices with patient chip card only.
2.1.1 Illustrated device components 1
2
3 4 5
6
15 8
1 2
14 14
4
10 5 7 13 12 11
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Chip Card - No. 16
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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 value
set flexion value
selected direction of motion
Extension control
Flexion control
Speed control
Pause control
START/STOP key (during operation: LED green, when stopped: LED yellow)
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2.2.2 Programming unit in speed or pause programming mode
selected function
set value of selected function (here: speed)
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2.2.3 Explanation of symbols Symbols on the programming unit: Extension (stretching the knee)
Go to start position (see Notes in 4.1)
Flexion (bending the knee)
Controls on programming unit locked (see Notes in 5.1)
Speed Pause (extension and flexion)
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Symbols that may appear in the display
Controls on programming unit unlocked (see Notes in 5.1) Service menu activated, for service purposes only (also refer to Service Manual)
2.3 Description of the programming unit – Standard and Comfort units 2.3.1 Programming unit in normal mode
patient chip card1
selected angle of the CPM device
selected therapy protocol
therapy timer
set extension value
set flexion value
selected direction of motion
parameter keys MENU key
“+” (plus) key
START key
“-” (minus) key
STOP key
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ptiFlex-K1® devices O with patient chip card only.
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2.3.2 Programming unit in MENU selection mode
selected MENU level set angle of the CPM device
set extension value
set flexion value parameters available for selection, corresponding selection keys
2.3.3 Programming unit in programming mode
selected function
set value of selected function (here: flexion angle) selected parameter (here: flexion)
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2.3.4 Explanation of symbols Standard protocols: extension (stretching the knee) flexion (bending the knee)
Comfort protocols: stretch extension stretch flexion workout protocol
speed
Comfort protocol
warm up protocol
EROM repeat extension
extension pause flexion pause therapy timer
reverse on load (feature for patient safety)
EROM repeat flexion EMS control therapy documentation
transport setting new patient total therapy time service menu
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2.4 E xplanation of symbols (connections and nameplate) Alternating current
Protection class I for < 20,000 equipment. The medical device must be connected to a system with protective earth conductor! Protection class II for > 20,000 equipment. The medical device has a double or reinforced insulation. Type B applied part
Power switch OFF
Power switch ON
The number next to this factory symbol is the year of manufacture (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# > 20,000) Caution! Observe warnings set forth in operation manual!
Observe Operation Manual (only S# > 20,000)
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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 information regarding disposal of the unit and accessories.
Protect from moisture
Listed by Intertek Testing Services NA Inc., 3087834
for S# < 20,000 equipment. Listed by Intertek Testing Services NA Inc.,
3087834
for S# > 20,000 equipment Caution: Federal law restricts this device to sale by or on the order of a physician. "Caution Rx Only". Warning! Depending on the device settings, the moving parts of the device present pinch points! Pay particular attention to small children and babies! (only S# > 20,000) The IP rating indicates the level of protection and thus the suitability of the device for use under different ambient conditions. The rating IP21 means: 2 is the level of protection against contact and solid objects. The digit 2 means: – Protection from contact: protected from contact with a finger – Protection against foreign object: protected against solid foreign object (diameter of 12.5 mm and greater) 1 indicates the degree of protection against water The digit 1 means: protection against vertically falling water drops (only S# > 20,000).
IP21 for S# > 20,000, IPXO for S# < 20,000
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3. Safety Information Introduction and definitions
Safety information
Read the safety statements before use of the CPM device. The safety statements are classified as follows:
Danger! Explosion hazard –
Indicates an imminent hazard. If not avoided, this hazard will result in death or serious injury.
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 cleansing agents and disinfectants.
Danger!
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.
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WARNING!
- Modifications to the medical device described in this document without the manufacturer's written consent is prohibited.
Patient hazard –
- It is important that the patient‘s position is anatomically correct. Therefore, carefully verify the following settings/positions:
- The simultaneous treatment of both legs by simultaneous use of two CPM devices is not permitted because the motion elements might interfere with each other.
1. femur length 2. knee joint axis 3. tibia length and leg rotation 4. leg support assemblies
- Stabiliy of the physiotherapy unit must always be ensured while it is in use. The OptiFlex-K1® must only be set up on surfaces that guarantee its stability. Very soft or unstable surfaces (such as waterbeds) are NOT suitable.
- Movements must not cause pain or irritation. - Patients must be fully conscious while being instructed in the use of the CPM device and during therapy. - Only the responsible physician or therapist is able and allowed to choose the therapy parameters 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 familiar with the functions of the OptiFlex-K1® programming unit and the unit must be within easy reach of the patient, allowing him or her to stop therapy, if needed. Patients unable to operate 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.1
- Do not allow parts of the body or objects (such as blankets, cushions, or cables) to get caught in the moving parts of the CPM device.
WARNING!
- Extreme caution should be taken when in use around small children and babies! Sufficient distance to the device is mandatory for their safety! - Never leave the device unattended when it is switched on! Switch the device off and disconnect the power line from the wall outlet! - After use, store the device in a safe place! Ensure device stability also during storage!
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OptiFlex-K1® devices with patient chip card only
- Any accessories used with OptiFlex-K1® must first be approved by DJO.
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WARNING!
hock hazard – S 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 temperature 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 connect the device to the power line. OptiFlex-K1® must be connected to a properly installed wall outlet with a non-fused earthed wire. Before connecting the power cord, it must be completely unrolled and placed such that it will not get caught by the moving parts of the device.
- Before cleaning and service interventions, disconnect the device from the power line by removing the power cord from the wall 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 immediately checked by a service technician, before it can be reused.
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 requirements. 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. - Persons are authorized after training by a specialist trained and commissioned by the manufacturer. - 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.
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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 moderate abduction position, if deemed appropriate.
CAUTION!
Equipment damage –
- Check that the voltage and frequency ratings of your local power line are those indicated on the nameplate. -T he leg support element withstands a maximum continuous load of 55.1 lbs (25 Kg) S# > 20,000 / 44.0 lbs (20 kg) S# < 20,000. - 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. - The presence of children, pets and rodents does not normally impair the functioning of the device. However, avoid contamination of the device by children or animals, from dust and lint, and keep them at a safe distance from the device. The safety statements set forth appy.
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4. Adjusting the Device Note: For a better understanding of each step, please see also pages 2 and 3.
4.1 Connecting the device, performance check – Classic Unit 1. Connect the power cord to socket (10) 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 (12) on. 3. Follow these steps to set the carriage to the home position. Press the Extension key
and, holding it depressed, rotate until 30° appears in the display above the control. In the same manner, select a Flexion value of 35°.
Then press the START/STOP key. When the carriage has reached this range and does not stop automatically, press the START/STOP key again to stop any movement.
Note!
OptiFlex-K1® will stop automatically in the home position range, only if it was positioned outside this range (30° to 35°) at the time of programming (also refer to 5.2)
Performance check If the programming unit can be operated as described above and 18
OptiFlex-K1® enters the home position (for home position values, refer to section 4.1), the device has passed the performance check. The device also runs performance checks regularly during operation. This is what happens, if a problem is identified: - An audio signal sounds. - The device switches off immediately. - The message “ERROR”, accompanied by a code number (e.g. ERROR 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 C onnecting the device, performance check – Standard and Comfort Units 1. Connect the power cord to socket (10) 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 (12) on. 3. Follow these steps to set the carriage to the home position. OptiFlex-K1® – Standard 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 unit). Press the “New Patient” parameter key. Press the START key. The CPM device automatically enters the home position. OptiFlex-K1® – Comfort with patient chip card Initial adjustment for new patients Insert the original patient chip card (15) into the programming unit (14). Press the MENU key on the programming unit until you reach program level 3 (standard model) or program level 5 (Comfort unit). Press the “New Patient” parameter key.
Press the START key. The CPM device automatically enters the home position.
Adjustment with programmed chip card. Insert the original patient chip card (15) into the programming unit (14). 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 position (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 identified: - 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.
4.3 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).
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