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.
OptiFlex-K1® Description........................................................................................................ 4 2.1 2.1.1 2.2 2.2.1 2.2.2 2.2.3 2.3 2.3.1 2.3.2 2.3.3 2.3.4 2.4
3. 4.
Adjusting the Device ........................................................................................................... 17 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
Setting the Treatment Values.............................................................................................. 20 5.1 5.2 5.3 5.4 5.5 5.6 5.7
6.
Description of the device components.......................................................................... 4 Illustrated device components....................................................................................... 5 Description of the programming unit – Classic Unit...................................................... 6 Programming unit in normal mode................................................................................. 6 Programming unit in speed or pause programming mode .................................................. 7 Explanation of symbols.................................................................................................. 8 Description of the programming unit – Standard and Comfort Units Programming unit in normal mode................................................................................. 9 Programming unit in MENU selection mode................................................................ 10 Programming unit in programming mode.................................................................... 10 Explanation of symbols................................................................................................ 11 Explanation of symbols (connections and nameplate) ................................................ 12
Safety Information................................................................................................................ 14 4.1 4.2 4.3 4.4
5.
Fields of application........................................................................................................ 3 Therapy objectives.......................................................................................................... 3 Indications....................................................................................................................... 3 Contraindications............................................................................................................ 3
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
C
D
E
F
1. How to Use the CPM Device 1.1 Fields of application 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 functional result. Other objectives of therapy include: - improvement of joint metabolism - prevention of joint stiffness -p romotion of the regeneration and healing of cartilage and damaged ligaments
1.3 Indications 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 -a rthrotomy and arthroscopy procedures in combination with synovectomy, arthrolysis or other intra-articular interventions -m obilization of joints in anesthetized patients -o perative treatment of fractures, pseudoarthrosis and osteotomy -c ruciate ligament replacement or reconstruction - endoprosthetic implant
1.4 Contraindications Do NOT use OptiFlex-K1® on patients with:
- faster hematoma/fluid resorption
-a cute 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. C ompartment for storage of programming unit
- physiological movements -p rogramming unit for precise adjustment of patient-specific therapy parameters - s ymbols for easy operation of the programming unit -p rogrammed 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
9
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
Speed control
Flexion 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
START key
“+” (plus) 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 Read the safety statements before use of the CPM device. The safety statements are classified as follows:
Safety information
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 –
-O nly 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. -B efore 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. -B efore 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. -S top therapy immediately, when you have doubts about the device settings and/or the therapy protocol.
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WARNING!
-M odifications 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: 1. 2. 3. 4.
-T he simultaneous treatment of both legs by simultaneous use of two CPM devices is not permitted because the motion elements might interfere with each other.
femur length knee joint axis tibia length and leg rotation leg support assemblies
-S tabiliy 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.
-M ovements must not cause pain or irritation. -P atients must be fully conscious while being instructed in the use of the CPM device and during therapy. -O nly 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. -T he 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. -A fter 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
-D o 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!
-E xtreme caution should be taken when in use around small children and babies! Sufficient distance to the device is mandatory for their safety! -N ever leave the device unattended when it is switched on! Switch the device off and disconnect the power line from the wall outlet! -A fter 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. -A llow 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. -W hen disconnecting the device from the power line, remove the plug from the wall outlet first, before disconnecting the cable from the device. -W hen 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. -D o 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.
-B efore cleaning and service interventions, disconnect the device from the power line by removing the power cord from the wall outlet. -L iquids 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 – -M agnetic 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. -P ersons are authorized after training by a specialist trained and commissioned by the manufacturer. -R oute 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. -D o not allow any objects (such as blankets, cushions, or cables) to get caught in the moving parts of the CPM device. -D o not expose the OptiFlex-K1® device to direct sunlight, because some of the components may reach inadmissibly high temperatures. -T he 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 A djusting the device to the femur length 1. M easure the length of the patient‘s thigh (femur) from the greater trochanter to the lateral knee joint cavity (Fig. A). 2. S et the carriage to the home position (see 4.1).
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3. Set the measured value at the femur scale (1) of the carriage. - Loosen the two fixation screws (2). -E xtend the scale (1) to the required length. -T ighten the fixation screws (2) to set the scale to the new length.
CAUTION!
CAUTION!
Equipment damage – Cover the leg support assemblies with disposable tissues when using OptiFlex-K1® immediately after surgery. This helps prevent discoloration.
Equipment damage – Do not attempt to extend the femur scale beyond the stop.
CAUTION! Patient hazard –
4.4 Adapting the leg support assemblies/ footplate 1. Set the leg support assemblies and the footplate (6) to the expected positions before accommodating the patient. - L oosen fixation screws (4) to adjust the footplate to the length of (6) the patient‘s lower leg (Fig. C). Loosen tightening screw (8) and adapt the footplate‘s rotation and height to the patient (Fig. D). Loosen fixation screw (7) 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. F) to adapt the footplate to shorter calves: •L oosen tightening screw (8) and remove the footplate (6). • Loosen the fixation screws (7). • Reverse the bracket 180°. • Screw the footplate to the bracket and tighten the tightening screw. 2. P lace the patient’s leg on the carriage and repeat the steps outlined under 1 above to adjust the device to the patient.
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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. E).
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. S etting the Treatment Values 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 as well as pages 6, 7, 8.
5.1 G eneral information on programming OptiFlex-K1® – Classic Unit 1. You activate a function by briefly pressing a control on the programming unit. 2. You select a treatment value by pressing the respective control and turning it in either direction. You increase a value by turning the control clockwise towards the + (plus) symbol and you decrease a value by turning the control counterclockwise towards the - (minus) symbol. For the first 5° the values in the display change in steps of 1°, then the interval changes to 5° so that you reach the target value faster.
When adjusting speed or pause, the information shown in the display changes automatically as you press the control. The selected parameter (speed or pause) is immediately represented by its symbol in a large format plus the current value (also refer to 2.2.2). The current value can be changed by turning the depressed control. When you have set the new value, release the control and the standard display reappears automatically after approx. 5 seconds (see also 2.2.1). 3. Subsequently press the START/ STOP key to start therapy.
Note!
Refer to sections 5.2 for a description of the parameters. -T o prevent accidental changes of the parameter settings, lock the programming unit by simultaneously pressing the "Extension" and "Speed" controls for 4 seconds.
Press both controls again for 4 seconds to unlock.
-E mergency stop function: OptiFlex-K1® will stop immediately, when any of the keys is pressed during therapy. Patient treatment can be resumed by pressing the START/STOP key. The device will automatically change the direction.
During adjustment of the extension and flexion angles, the values in the display change as you turn the control after pressing it. 21
- If the carriage is positioned within the programmed range of motion at the time therapy begins, the therapy session will start immediately. If the carriage is positioned outside the programmed range of motion at the time therapy starts, it will first enter the position “extension +10°”. The carriage will stop in this position and you can initiate the therapy session by pressing the START/STOP key again.
5.2 Information about the OptiFlex-K1® therapy parameters – Classic Unit -Y ou select a function by pressing the corresponding control -Y ou change the treatment values by turning the depressed control. -Y ou initiate the treatment session by pressing the START/STOP key n Extension (streching) - M aximum knee extension: -10 degrees - M aximum hip extension: 7 degrees n Flexion (bending) - M aximum knee flexion: 120 degrees - M aximum hip flexion: 115 degrees
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Note!
The programmed value and the value measured at the patient‘s knee may deviate slightly.
n Speed The speed can be adjusted between 5 % and 100 % in steps of 5 %. Default setting: 50 % n Pauses Pauses occur at the selected limits where stretching turns into bending and bending into stretching (selected extension and flexion values). The value entered applies to both extension and flexion pause. 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. When selecting the seconds, the value changes in 1-second steps for the first five seconds. Subsequently the interval changes to 5-second steps. The minutes are always adjusted in 1-minute steps. Default setting: no pause
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 2.5 and 2.6, pages 9, 10, 11
5.3 General information on programming OptiFlex-K1® – Standard and Comfort Units 1. You activate the programming mode by briefly pressing the MENU key on the programming unit.
This is what happens when you press one of the parameter keys to select a parameter: -T he corresponding symbol appears on the display in a larger format. - The set value is displayed. -T he symbol above the parameter key appears in reverse video. 4. W ith 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. 5. H aving programmed all parameters, press the STOP key to save the values. 6. T hen press the START key to start therapy.
2. The various treatment parameters and functions are allocated to three (standard model) or five (Comfort unit) programming levels (four per level). To be able to program a parameter you will have to access the corresponding 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 parameters and functions with the four parameter keys below the display. The symbols above the four parameter keys indicate the assigned parameters and functions.
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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. -T o prevent accidental changes of the parameter settings, you can lock the keys. To do so, simultaneously press keys + and – for approx. 4 seconds. Press both keys again for approx. 4 seconds to unlock.
5.4 P rogramming OptiFlex-K1® – Standard Unit Different programming levels are provided 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 (14): LEVEL 1:
-S electing the “New Patient” function will automatically delete the data on the patient chip card. When you have finished programming the unit and press the STOP key, the settings will automatically also be saved to the patient chip card. -E mergency stop function: OptiFlex-K1® will stop immediately, 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.
atients with a programmed P chip card - Insert the chip card (the patient is not yet positioned on the CPM device). -P erform the mechanical adjustments of the CPM device (femur length, etc.). -P osition the patient on the CPM device and press the START key to initiate therapy.
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- extension (stretching the knee) - flexion (bending the knee) - speed - warm up protocol LEVEL 2:
MENU
- extension pause - flexion pause - therapy timer - reverse on load (feature for patient safety) LEVEL 3:
MENU
- transport setting - new patient - total therapy time - Service menu
Note!
- W hile 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. -S pecial functions can be programmed and retrieved with OptiFlex-K1® Comfort devices (see sections 5.6 and 5.7). -O nly OptiFlex-K1® chip card models allow therapy protocols to be saved to an inserted chip card.
5.5 T reatment value details – Standard Unit You access the different programming levels by repeated depressions of the MENU key. -Y ou select the treatment parameters with the corresponding parameter key. -Y ou change the treatment values with the +/- keys and you enable/disable functions by pressing the corresponding parameter key again. -Y ou save the settings by pressing the STOP key. LEVEL 1: n extension (stretching) - maximum knee extension: -10 degrees - maximum hip extension: 7 degrees n flexion (bending) -m aximum knee flexion: 120 degrees
Note!
he programmed value and the T value measured at the patient‘s knee may deviate slightly. n speed The speed can be adjusted between 5% and 100% in steps of 5%. default setting: 50% n warm up protocol 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: n extension pause auses occur at the extension limit, P 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 n flexion pause 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
-m aximum hip flexion: 115 degrees 25
n therapy timer Default setting is continuous operation of the carriage. A clock symbol in the upper righthand corner of the display identifies the continuous mode of operation. The clock indicates the elapsed therapy 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 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. n r everse 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
n transport setting ith this function, the carriage will W 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) n new patient 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 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%
Patient hazard –
- warm up:
disabled
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.
- extension pause:
0
- lexion pause:
0
CAUTION!
26
LEVEL 3:
- timer: continuous operation - reverse on load::
25
- total therapy time:
0
n total therapy time 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.
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 LEVEL 2:
MENU
n Service MENU
- extension pause
For service purposes only, refer to Service Manual.
- flexion pause
Reminder:
- reverse on load (feature for patient safety)
You save the set parameter values by pressing the STOP key.
5.6 P rogramming OptiFlex-K1® – Comfort Unit OptiFlex-K1® devices of the Comfort series offer two more programming levels for additional functions. The programming 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.
- therapy timer
LEVEL 3:
MENU
- stretch extension - stretch flexion - workout protocol - Comfort protocol LEVEL 4:
MENU
- EROM repeat extension - EROM repeat flexion - total therapy time Continued on next page.
27
LEVEL 5:
MENU
- transport setting - new patient - therapy documentation - Service menu
5.7 Protocol details – Comfort Unit -Y ou access the different programming levels by repeated depressions of the MENU key. -Y ou select the treatment parameters with the corresponding parameter key. -Y ou change the treatment values with the +/- keys and you enable/disable functions by pressing the corresponding parameter key again. -Y ou save the settings by pressing the STOP key. All special functions are disabled upon delivery 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: n stretch extension 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.
28
ubsequently the carriage reverses S 5 ° toward the flexion angle and then moves very slowly back again to the programmed extension limit (display <=). After that it attempts to stretch the joint another 5 °, moving even slower than before (display <<). If a high resistance toward the additional 5 ° is sensed, the reverse on load function is automatically activated 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 special “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 maximum stretching value is attained. n stretch flexion With the special “stretch flexion” function the joint will be gently stretched beyond the flexion limit. Starting at the middle position the carriage will first move to the programmed extension limit and then to the programmed flexion limit. Subsequently the carriage reverses 5 ° toward the extension angle and then moves very slowly back again to the programmed flexion limit (display =>). After that it attempts to stretch the joint another 5 °, moving even slower than before (display >>). If a high resistance toward the additional 5° is sensed, the reverse on load function is automatically activated 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 programmed, the carriage will stop for the pause each time the maximum stretching value is attained. n 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 complete. Protocol stages: - 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 extension - 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.
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. n Comfort protocol 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 limit values have been attained, the CPM device continues in the programmed range of motion until the end of the therapy session. LEVEL 4: n EROM repeat extension The special “EROM repeat extension” function allows a more efficient exercise 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 flexion angle and then moves back again to the maximum extension 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 flexion value and then starts another cycle with five repetitions through the last 10 ° of the extension angle. 29
n EROM repeat flexion The special „EROM repeat flexion” function allows a more efficient exercise 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 flexion 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. n total therapy time 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.
LEVEL 5: n transport setting 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) n new patient 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 carriage moves to the home position. With OptiFlex-K1® devices with patient chip card, 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
30
- Comfort protocol:
disabled
- workout protocol:
disabled
- therapy documentation:
reset
n therapy documentation
n Service menu
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.
For service purposes only, refer to Service Manual.
®
Reminder: You save the set parameter values by pressing the STOP key.
6. Care, Maintenance, Transport 6.1 Care WARNING! Shock hazard –
Unplug the device from the power line before cleaning. Shock hazard, equipment damage – Liquids must not enter the device or the programming unit. -O ptiFlex-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. -U se only a damp cloth to wipe the carriage down.
WARNING! Patient hazard – patient contamination
Before using the device on another patient, be sure to clean and disinfect it according to the instructions given here.
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.
31
6.2 M aintenance (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 patient 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.
WARNING!
Patient hazard – equipment malfunction and damage Refer repair and maintenance to authorized persons. Persons are authorized after training by a specialist trained and commissioned by the manufacturer. DJO Global will make all documents required for servicing, such as circuit diagrams, parts lists, descriptions or calibration instructions, available to authorized experts. These checks should be performed by persons with adequate training and experience. Damaged and worn parts must immediately be replaced with original spare parts by authorized staff. The device does not require additional regular maintenance. Fuse replacement
32
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). uses used must be T1A S# < 20,000 F and T2A S# > 20,000.
6.3 Transport Follow these steps to prepare the OptiFlex-K1® for transport: 1. A djust the femur length to 49 inches and the tibia length to 42 inches. 2. S elect the “Transport setting” from the menu (refer to 5.3 for details). 3. P ush the power switch to turn off the OptiFlex-K1®. 4. D isconnect the power cord and the programming unit. 5. T he 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. N ow slide the polystyrene pads onto the OptiFlex-K1®. 8. P lace 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. Programming Unit
Power cord
7. E nvironmental Protection Statement The product described in this operation manual must not be disposed of with unsorted household or municipal waste. 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 Model:
OptiFlex-K1®
Input ratings: 100 – 240 V AC/ 50 – 60 Hz Current consumption:
850 – 370 mA
Fuses: S# <20,000: 2x T1A L250Vac S# >20,000: 2x T2A H250Vac Protection class:
S# <20,000: class I S# >20,000: class II
IP class:
S# <20,000: IPX0 S# >20,000: IP21
Applied part:
Type B
Max. load on carriage:
S# <20,000: 40.0 lbs (20 kg) S# >20,000: 55.1 lbs (25 kg)
Dimensions length: 96 cm width: 35 cm height: min. 23 cm to max. 56 cm Adjustment ranges (min./max.): femur range: approx. 31 – 49 cm lower leg range: approx. 25 – 57 cm weight:
23 lbs
materials used: ABS, POM (Delrin 100), PUR, PA, FR4, aluminium, stainless steel, brass
Standards compliance: IEC 60601-1:1988+A1:1991+A2:1995 (S# <20,000) IEC 60601-1:2005 (S# >20,000) IEC 60601-1-6:2006 IEC 60601-1-9:2007 IEC 60601-1-11:2010 (S# >20,000) IEC 62366:2007 IEC 62304:2006 EN ISO 14971:2007 ANSI/UL 60601-1 (S# <20,000) CAN/CSA C22.2 No. 601.1-M90 (S# <20,000) ANSI AAMi ES 60601-1 1st edition (S# >20,000) CAN CSA 22.2 No. 60601-1-08 EMC S# <20,000: (electromagnetic IEC 60601-1-2:2001 compatibility) S# >20,000: IEC 60601-1-2:2007 Certification: ANSI/UL 60601-1 CAN/CSA C22.2 No. 601.1 Ambient conditions (storage, transport) temperature: -25 ºC to + 70 ºC (-12 °F to + 140 °F) relative humidity: atmospheric pressure:
70 ºC up 93% no condensation 500 hPA to 1060 hPa
Ambient conditions (operation) temperature: +5 ºC to + 40 ºC (50 °F to + 104 °F) relative humidity: 15% to 93% atmospheric pressure: 700 hPa to 1060 hPa Subject to change without notice. (06/2013) 33
9. IEC 60601-1-2:2007 and 60601-1-11:2010 The OptiFlex-K1®device is subject to particular precautions regarding electro-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. If you detect damage or malfunctions that may impair the safety of the patient or of the operator, have the device repaired before using it. If it is necessary to replace assemblies or cables, only the manufacturer's original parts must be used to ensure continued compliance with EMC requirements after repair. This requirement applies to the power supply unit, cables and cable lengths, drive unit consisting of the motor and the control system, the programming unit including the coiled cable and the connector. The product designation OptiFlex-K1® used in the text below includes all product variants. 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.
34
Emissions test
Compliance
Electromagnetic environment – guidance
RF emissions to CISPR 11
Group 1
OptiFlex-K1® uses RF energy only 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 CISPR 11
Class B
OptiFlex-K1® is suitable for use in all establishments, including domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Harmonic emissions to IEC 61000-3-2
not applicable
Voltage fluctuations/ flicker emissions to IEC 61000-3-3
not applicable
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 used in such an environment. Immunity test
IEC 60601-test level
Compliance level
Electromagnetic environment - guidance
Electrostatic discharge (ESD) to IEC 61000-4-2 ± 6 kV contact
± 6 kV contact
± 6 kV contact
± 8 kV air
± 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± 2 kV for power sient/burst to IEC supply lines 61000-4-5 ± 2 kV for power supply lines ± 1 kV for input/ output lines
± 2 kV for power supply lines
± 1 kV differential mode
± 1 kV differential mode
± 2 kV common mode
± 2 kV common mode
Surges to IEC 61000-4-5
Voltage dips, short interruptions and voltage variations on power supply input lines to IEC 61000-4-11
Mains power should be that of a typical commercial or hospital environment.
< 5% UT (> 95% dip in UT) for 5 s
Mains power should be that of a typical commercial or hospital environment. If the user of the 40% UT OptiFlex-K1® device (60% dip in UT) for requires continued opera5 cycle tion during power mains interruptions, it is recom70% UT mended that the (30% dip in UT) for OptiFlex-K1® device be 25 cycles powered from an uninterruptible power supply or a < 5% UT battery. (> 95% dip in UT) for 5 s
3 A/m
3 A/m
< 5% UT < 5% UT (> 95% dip in UT) (> 95% dip in UT) for ) cycle for ) cycle 40% UT (60% dip in UT) for 5 cycle 70% UT (30% dip in UT) for 25 cycles
Power frequency (50/60 Hz) magnetic field to IEC 610004-8
± 1 kV for input/ output lines
Mains power should be that of a typical commercial or hospital environment.
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: UT is the a.c. mains voltage prior to application of the test level.
35
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 test level
Compliance level
Electromagnetic environment-guidance Portable and mobile RF communications equipment should be used no closer to any part of the OptiFlex-K1® unit, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmiatter. Recommended separation distance:
Conducted RF to IEC 61000-4-6
3 Vrms 150 kHz to 80 MHz
3 Vrms
d =
r 1.2 öP
d = 1.2 800 MHz
r
öP
d = 2.3 2.5 GHz
r
öP
80 MHz to
800 MHz to
where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer andd is the recommended separation distance in meters (m).
Radiated RF to IEC 61000-4-3
3 V/m 80 MHz to 2.5 GHz
3 V/m
Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey a), is less than the compliance level in each frequency rangeb. Interference may occur in the vicinity of equipment marked with the following symbol
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 abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the OptiFlex-K1® device. b) O ver the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
36
9.3 R ecommended 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 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 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 power of transmitter W
separation distance according to frequency of transmitter m 150 kHz to 80 MHz
d = 0.01 0.1 1 10 100
r 1.2 öP
80 MHz to 800 MHz
d =
r 1.2 öP
800 MHz to 2,5 GHz
d =
r 2.3 öP
0.12
0.12
0.23
1.2
1.2
2.3
12
23
0.38 3.8 12
0.38
0.73
3.8
7.3
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 calculation 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. NOTICE! (for home use) Portable and mobile RF communication systems may affect the OptiFlex-K1® device. For this reason, make sure that wireless communication equipment, such as wireless home network devices, cell phones, cordless telephones and their base stations and walkie-talkies operate at a minimum distance of 3.3 m from the device. (Calculated on the basis of the maximum power output of a typical cell phone of 2 W).
10. How To Reach Us Service, warranty or repair, please contact the selling dealer or your local DJO customer service.
37
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 Section 6.3).
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!
efer repairs to authorized, R specially trained staff. JO offers service training for your D personnel.
38
Surcharges may apply in certain cases to spare parts ordered in low quantities.
Notes
39
Notes
40
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