FIGURES 3 DESCRIPTION OF SYMBOLS 5 SAFETY PRECAUTIONS 6 SAFETY STANDARDS AND CLASSIFICATION 7 SYMBIONIC LEG 3 FUNCTIONS 7 EXTENSION LOCK 8

Transcription

1 Technical Manual

2 Contents FIGURES 3 DESCRIPTION OF SYMBOLS 5 ABBREVIATIONS 5 SAFETY PRECAUTIONS 6 SAFETY STANDARDS AND CLASSIFICATION 7 SYMBIONIC LEG 3 FUNCTIONS 7 EXTENSION LOCK 8 INDICATIONS FOR USE 8 TECHNICAL SPECIFICATIONS 9 CHARGING AND POWER 9 MAINTENANCE 10 WARRANTY 10 CATEGORY SELECTION CHART 10 SET-UP PROCEDURE 10 USER TRAINING 14 APPENDIX 16 BLUETOOTH MODULES REGULATED INFORMATION 19

3 1 2 1/2 = 0 90% 1/2 = % = FULL 90 min = 90% 1/3 1/3 3 H = Full 1/

4 8 Warnings Indicates 2 beep Approximately 5 hours left 3 beep Approximately 4 hours left 4 beep Approximately 3 hours left 5 beep Approximately 2 hours left Ankle will return to neutral (last set heel height) Yellow LED is solid ON 1 Long high pitch beep Symbionic Leg will turn OFF 9 Function Hold Press Beep & Vibration LED Power ON/OFF 2 ON Blinking green & yellow 3 OFF OFF Set heel height 2 1 Move Blinking green & yellow 1 Start Solid yellow 1 Complete Move to Neutral/Relax 4 1 Neutral 0 Relax Manual ankle operation 6 Solid green, blinking yellow Sound ON/OFF 7 0 OFF 1 ON Ankle calibration ON/OFF 9 1 OFF 1 ON Blinking green & yellow Note: The keypad will be disabled 60 seconds after use. To enable the keypad, hold both buttons for at least one second. 10 Stair Mode Sequence Hold Press Beep Stair Mode 4 2 Stair Mode Stair Mode OFF 1 11 Relax Mode Hold Press Beep Relax Mode OFF 1 Relax Mode ON 5 2 Chair Exit Mode only 3 4

5 ENGLISH DESCRIPTION OF SYMBOLS Attention See instructions for use On / Off Type B Applied Part (IEC ) CE label with Notified Body identification number Non-ionizing radiation Manufacturer and date of manufacturing Consult Instructions for use ABBREVIATIONS This marking on the product, packaging, accessories or literature indicates that the product contains electronic components and/or batteries that should not be disposed of in regular waste at the end of its usable life. To prevent possible harm to the environment or human health from uncontrolled waste disposal users are requested to separate these items from other types of waste and recycle them responsibly to support sustainable reuse of material resources. Users should contact their local government office for information on how these items can be recycled or disposed of in an environmentally sound manner. To protect natural resources and to promote material reuse, please separate batteries and electrical components from other types of waste and recycle them through your local, free electronic parts return system. Vibration feedback signal. Auditory feedback signal BEEP 5

6 SAFETY PRECAUTIONS Please follow the safety precautions, as failure to do so can lead to malfunction of the system-, and risk of injury. 1. If the SYMBIONIC LEG 3 loses power, the knee loses its ability to provide stance support. In such cases it is recommended to manually engage the integrated extension lock to lock the knee in full extension. The knee allows full weight bearing when locked. 2. Make sure that the user is able to recognize the auditory and/or vibratory signal for power loss when completing daily living activities. 3. The knee-module stance-control settings may be customized to maximize security or terrain recognition, depending on the user's preference. For maximum safety, it is recommended that a handrail be used when descending stairs and ramps. Steep inclines or declines (above 20 ) may trigger the stair response, resulting in unexpected foot alignment. 4. Improper adjustment of the SYMBIONIC LEG 3 will cause suboptimal function, which can increase the risk of falls. The SYMBIONIC LEG 3 must only be fitted by a clinician who has attended and passed an Össur certified SYMBIONIC LEG 3 education program. 5. When making adjustments to the SYMBIONIC LEG 3, ensure the user is seated or in a stable standing position. 6. The healthcare practitioner must provide each patient with training for appropriate use and proper application of the system. 7. The user should stop walking immediately if alarm signals are felt or heard. Proceed to walk with caution. 8. The SYMBIONIC LEG 3 is designed for everyday use. The prosthesis must not be used for sports or constant high-impact activities (e. g. running, climbing, etc.). 9. The SYMBIONIC LEG 3 is battery operated and caution should be taken about exposure to water, excessive mechanical shocks or vibrations. 10. Avoid impact to the interface panels on the back of the knee module and to the interface panel at the front of the ankle module. Damage to these panels or any of their components may cause product malfunction. Do not use if the product enclosure or covers are broken. 11. Do not attempt any repairs or service functions to the SYMBIONIC LEG 3. This may cause damage to the prosthesis, possible malfunction, or failure, and voids the warranty. The battery can only be changed by an authorized service technician. 12. The power supply provided with the unit is certified to comply with medical electrical equipment standards and it is therefore not safe to use any other power supply equipment. 13. Do not use in highly electrical and/or magnetic environments (e. g. electrical transformers, high-power radio/tv transmitters). Avoid exposure to extreme heat and/or cold (see chapter Technical Specifications). Avoid exposure to intense dust, smoke, or mechanical vibrations. 14. Not suitable for use in the presence of a flammable, anesthetic mixture containing air oxygen or nitrous oxide. 15. Follow local ordinances or regulations for proper disposal of device, accessories, and packaging. 16. Batteries should be disposed of in accordance with local laws and regulations. They should not be incinerated. 6

7 17. Caution should be taken with respect to the use of the SYMBIONIC LEG 3 inside of a motor vehicle. Inadvertent movement of the ankle may interfere with control functions of brake and/or accelerator. When preparing to drive, turn the SYMBIONIC LEG 3 off (see chapter Power OFF). Caution: U.S. Federal law requires this device to be sold by a prosthetist and on the order of a physician. SAFETY STANDARDS AND CLASSIFICATION The SYMBIONIC LEG 3 is tested and certified to comply with the IEC/ EN standard for electrical safety of medical devices, the IEC/ EN standard for electromagnetic compatibility for medical electrical devices, and ISO The company fulfills the requirements of ISO The product complies withe MDD 93/42/EEC, and carries the CE mark accordingly. This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. SYMBIONIC LEG 3 FUNCTIONS 1. ANKLE FUNCTIONS Dorsiflexion during swing phase The user is actively assisted in swing phase, as the ankle uses motor power to dorsiflex the foot: Improves gait symmetry. Reduces the likelihood of catching the toe (improves ground clearance). Adaption of ankle position As the user walks, the ankle adapts to inclines, declines, and stairs. Offers a natural gait dynamic. Reduces pathological gait. Reduces the risk of falls. Note: Steep inclines or declines (above 20 ) may trigger stair response, resulting in unexpected ankle adaptation. Heel height adaptation The ankle of the SYMBIONIC LEG 3 provides the user with the ability to automatically adjust the ankle position to a range of shoe heel heights, conveniently allowing a choice of shoes. Sitting down With the relax mode activated the ankle of the SYMBIONIC LEG 3 will plantar flex in sitting (it is off by default). More natural appearance. Enhanced comfort. Standing up The ankle of the SYMBIONIC LEG 3 assists in standing up from a seated position through an adaptation of its ankle position. More controlled transition from sitting to standing. 7

8 Kneeling down The SYMBIONIC LEG 3 has the ability to plantar flex when kneeling and also when lying down. More natural appearance. Enhanced comfort. 2. KNEE FUNCTIONS Automatic adjustment to different surfaces and walking speed Microprocessor controlled stance phase resistance assists the user in maintaining knee stability on a variety of surfaces. Microprocessor controlled swing phase resistance samples and adjusts to the users walking speed during swing at a rate of 1000 times per second (1000 Hz). This allows the user to achieve comfortable and symmetric transitions among wide ranges of walking speeds. Excellent adjustability Adjustable stance flexion provides adjustable stance resistance for varying degrees of knee flexion during loading response. Adjustable stance extension provides adjustable stance resistance to knee extension between loading response and midstance. Leads to dampened extension force and shock absorption. Magnetorheologic fluid actuator means light weight feel and frictional resistance Magnetized fluid provides frictional resistance to flexion and extension movement. The actuator weight is located proximal in the knee providing a lightweight feel during swing phase. System flexibility and simplicity Integrated sensor pylon allows for simple connections to foot and shock systems without use of specialized pylons. Provides the ability to change height or foot rotation without recalibration or system reset. Contributes to low build of prosthesis and allows for increased number of foot options. EXTENSION LOCK See Figure 7 INDICATIONS FOR USE LOW TO MODERATE IMPACT USE ONLY Description: Community and workplace ambulators with ability or potential for cadence variation and ramp/stair descent. Activity examples: Shopping, gardening, longer walks, golfing. Weight limit: 125 kg (275 lbs). Distance from knee center to floor should be greater than or equal to 40 cm (approximately 16"). Do not: Immerse in water or any other fluids. Use in dirty environments. Expose to extreme heat and/or cold 8

9 TECHNICAL SPECIFICATIONS ENVIRONMENTAL Operating temperature: C ( F) Operating humidity: 0 90% (non-condensing) Operating atmospheric pressure: hpa Shipping and storage temperature: -10 to +45 C ( F) Shipping and storage humidity: 5 90% (non-condensing) Shipping and storage atmospheric pressure: hpa SYSTEM COMPONENTS SMBEXYY0: SYMBIONIC LEG 3 PRX60037: Power supply w/plug SOFTWARE REQUIREMENTS RHEOLOGIC software 1.2 or greater. CHARGING AND POWER Prior to the fitting of the SYMBIONIC LEG 3, charge the unit for 3 hours to ensure a full charge (Figure 2). Caution: Take the prosthesis off prior to charging. The SYMBIONIC LEG 3 should be charged daily for optimal performance. It is not possible to overcharge the SYMBIONIC LEG 3. The SYMBIONIC LEG 3 can be charged regardless whether it is turned ON or OFF. Insert the charger cable into the charging port on the user interface panel off the knee module. BATTERY CAPACITY Fully charged battery is sufficient for hours of continuous use, depending on activity. WARNING SIGNALS FOR POWER LOSS Vibratory and/or auditory warning systems are provided by the system to indicate to the user that power loss is forthcoming. The warning signals are provided in a series of intermittent pulses. The sequence of pulses is described in (Figure 9). Ensure that the user recognizes the warnings. When the battery charge is low and the warning pulses for power loss are delivered, the foot will return to the latest preset heel height position, and the knee module will turn off. The SYMBIONIC LEG 3 should not be used when the power is off. POWER SUPPLY Power input: An external power supply for medical use. Input: VAC Input frequency: HZ Input current: 0.6 A - RS Output Voltage: 24 VDC Output Current: 1.0 A Operating temperature: C Operating humidity: 10 90% RH (non-condensing) Manufacturer: UE Electronic 9

10 Model No.: UE24WCP SPA MAINTENANCE Do not disassemble the SYMBIONIC LEG 3, remove the battery pack or attempt repairs as this may create a user hazard and will automatically void warranty. The unit shall be sent to Össur for repairs or maintenance. No other company or individual is allowed to service or repair the unit in any way. To ensure proper function, it is recommended that the SYMBIONIC LEG 3 be inspected every six months by a qualified professional. Check for signs of unusual wear. CLEANING Clean the SYMBIONIC LEG 3 with a damp cloth and mild soap or isopropyl alcohol. Do not use solvents stronger than isopropyl alcohol. Do not use compressed air to clean the SYMBIONIC LEG 3, as it can cause the prosthesis to malfunction and deteriorate prematurely. WARRANTY See Terms of Warranty for details. CATEGORY SELECTION CHART Please refer to the selection charts below to determine the appropriate stiffness required according to Össur recommendations. WEIGHT KG WEIGHT LBS Low Impact Level Moderate Impact Level SET-UP PROCEDURE SYMBIONIC LEG 3 SET-UP PROCEDURE OVERVIEW Bench Alignment 1. SYMBIONIC LEG 3 on 2. Calibrate knee 3. Bench alignment 4. Heel height adjustment on bench Dynamic Alignment 5. Ankle calibration 6. Optimize ankle settings 7. Finishing 1. TURN SYMBIONIC LEG 3 ON AND OFF See Figure 9 When the SYMBIONIC LEG 3 is activated for the first time, the default manufacturer settings will be enabled. In the default manufacturer settings, sound is on, the Stair Mode and the Relax Mode are turned off (Figure 10). 10

11 2. CALIBRATION OF KNEE MODULE Requirements for calibration RHEOLOGIC software is required to calibrate the knee module. Refer to the RHEOLOGIC technical manual for information on how to connect to the knee module and modify adjustable parameters. The following values are acceptable calibration ranges for angle and load: Angle (-2 to 3 ) Toe load (-2.5 to 2.5) Heel load (-2.5 to 2.5) If the calibration values are out the given ranges, calibration is required How to calibrate the knee module 1. Before starting make sure there is no load on the knee and do not connect the socket to the knee. 2. Make sure the knee is fully extended. 3. Connect to the knee using the RHEOLOGIC software. 4. Open the Calibrate tab in the RHEOLOGIC software and press the Calibrate button. 5. When calibration is complete the knee module will provide a sound/vibration signal. Important: Improper calibration (for example if load is applied on the knee or socket is connected) affects the knee's ability to perform optimally and may compromise the user's safety. 3. BENCH ALIGNMENT Optimize length/alignment of pylon and adaptors Fit the foot with the selected cover and shoe. Establish the correct height of the prosthesis using the appropriate components. Ensure that the alignment is correct in the sagittal and coronal planes. Correct position of the alignment reference line should bisect the socket, fall between 5 mm anterior to 5 mm posterior of the knee center of the knee module and fall on the posterior 1/3 of the carbon plate (Figure 1). Caution: As the alignment reference line is positioned more posterior to the knee center, the user will experience more stance flexion during loading response. Additional voluntary control will be required to maintain knee stability when power is off. Important: At maximum flexion, maintain minimum distance of 3 mm (1/8") between the knee module and the socket. At maximum flexion where contact cannot be avoided due to socket volume, ensure contact is on the frame, directly below the user interface panel. For maximum pressure distribution, maintain a flat and cushioned contact surface (Figure 3). Make sure the connection cable lies flat against the surface of the prosthesis because a loose cable can get caught. Observe the cable position during walking, and make changes to the assembly if necessary. Use of heel wedges Optimum functional benefits will be achieved only when the rollover 11

12 function is optimized. The heel wedge can influence the heel-to-toe function. Start changing the heel resistance to improve foot response by adding a heel wedge. The 2, 4, and 6 wedges can be substituted to customize the stiffness of the heel and achieve the desired functional characteristics. A combination of wedges may be used. Have the user walk on even ground and assess proper heel-to-toe function. Temporary Wedge Placement (Figure 4) Cut the wedge to the width of the foot module. Roughen the upper and lower surface of the wedge with abrasive paper. Place the wedge in the angle of the heel and foot module. Secure the wedge in position with tape wrapped around the foot module. Permanently fix wedges when ankle module is used for more than a couple of days. Temporarily fitted wedges will move out of position and cause functional issues. Failure to do so can void the warranty. 4. HEEL HEIGHT ADJUSTMENT ANKLE MODULE The ankle module can be adjusted for variable heel height. The heel height adjustment ensures correct alignment of the prosthesis. Heel height adjustment on the bench Wear suitable footwear and ensure free ankle motion. With power on and the prosthesis standing on a level surface, initiate heel height adjustment by holding down the upper button and pressing the lower button twice (Figure 9). Note: Pay attention to the audible feedback. Note: If the heel height exceeds 50 mm (2"), a signal will be heard and the unit will not adjust to the heel height. Change shoes for lower heel height and repeat the adjustment. Ensure free ankle motion. 5. ANKLE CALIBRATION Calibration must be performed during the initial fitting to calibrate the ankle module to the user's individual gait. During calibration, the ankle module recognizes the user's specific gait parameters, allowing for accurate and consistent terrain detection. For calibration, the user must walk on level ground for at least 15 consecutive strides without interruption. Have the user stand still. Make sure the keypad is active (the. LED will blink green and yellow). Make sure the user has access to a path on level ground long enough to complete at least 15 strides without interruption. Enable calibration (Figure 9). Have the user walk on level ground at a self-selected walking speed until completion of calibration is confirmed by a beep and vibration (the. LED will blink green). The system is now properly calibrated to the user and enabled for normal adaptive functions. Note: Make sure the surface is completely flat. It is recommended that calibration be performed on an indoor surface. No sharp turns should be taken during calibration. Note: The user may take gentle turns during the calibration walk. If the calibration is not completed after approximately 15 strides, see below. 12

13 Ankle calibration troubleshooting: Ensure the correct alignment. Ensure there are no extreme gait deviations, such as significant circumduction or rotation, as this may prevent the completion of calibration. Ensure a consistent walking speed. Avoid walking in a circle or sharp curves. If calibration is not confirmed after 15 strides, you must perform the calibration again. If the alignment is changed, you must perform the calibration again. If for any reason the LED turns red, the procedure must be repeated. 6. OPTIMIZE SETTINGS OF ANKLE MODULE STAIRS (Figure 10) During stair ascent, the ankle module will raise the toe. This will facilitate stair ambulation and improve gait symmetry. When leading with the prosthetic side, the ankle module will adapt to this position after the second prosthetic step on the stairs. Note: Pay attention to transitions to and from stairs. When the ankle module is activated for the first time, the default manufacturer settings will be enabled. In the default manufacturer settings, the stair response is turned off. To change the stair response, see Figure 10. Relax mode / chair exit mode (Figure 11) Relax mode allows the ankle to move into full plantar flexion, which will provide improved body symmetry to the natural limb when sitting. Relax mode is off by default. Initiate Relax mode in a sitting position by extending the knee for at least 2 seconds. This provides a more natural ankle position when sitting with the lower leg extended. Following the Relax mode, the ankle module will move into Chair Exit mode. To initiate this, use one of the following methods: 1. Tap the heel of the foot. 2. Flex the knee and place the foot beneath the chair. Lift the foot to allow the adjustment to take place. The ankle will move to dorsiflexion, which enables the user to bring the leg further back, providing a more controlled transition from sitting to standing. The ankle will move back to neutral after the first step. 7. FINISHING Permanent Wedge Placement Apply adhesive to the upper side of the wedge only. Locate it in the foot/heel junction, and position it before the adhesive sets. For split toe feet, first install the heel wedge and then remove a thin slice in the middle by cutting with a sharp knife through the split in the carbon foot module (Figure 5). Flex-foot sock FCX63007 (Figure 6) To protect the cover a Flex-Foot sock is fitted over the foot module before applying the cover. The sock should fit loosely in the heel area. To hold 13

14 the Flex-Foot sock in place, attach the self-adhesive velcro tabs to the sides and front of the ankle. Press the Flex-Foot sock firmly onto the tabs to hold in place. It is important that the Flex-Foot sock doesn't slip down, as this will cause interference with the ankle module function and performance. Foot cover removal If you need to remove the foot cover, hold down the cosmetic cover with a hand on the rear aspect of the cosmetic cover. The heel module will snap out of the heel clip. Continue to pull and remove the foot completely. Note: Do not use a Flex-Foot shoehorn or any other lever to remove the foot cover, as this may cause damage to the ankle module. Socket/frame contact points Do not remove the unit's protective cover! This will immediately void the SYMBIONIC LEG 3 warranty. Care should be taken when configuring the socket/frame and adapters so that contact only occurs at the posterior apex of the SYMBIONIC LEG 3. The SYMBIONIC LEG 3 may be fit with continuous or discontinuous foam covers. Össur recommends fitting the SYMBIONIC LEG 3 with a discontinuous cover. Do not use talcum powder to eliminate noise caused by the application of a cosmetic cover. It may lead to malfunctions and early deterioration of mechanical parts. Instead use silicone spray. Be careful to apply it only to the knee cover. Once the foam cover has been applied, swing phase settings may need modification. Follow-up procedure checklist During follow-up visits, the following procedures are recommended to ensure that the SYMBIONIC LEG 3 is operating at an optimal level for the user: 1. Evaluate swing phase elements: heel rise, terminal impact, and extension rate. Adjust flexion target angle and/or swing extension resistance as needed. 2. Evaluate stance phase elements: stance flexion / stance extension. Adjust as needed for proper support on level ground, ramps, and stairs. 3. Ask the user if any warning signals have been encountered during the period of use. 4. Check knee module calibration. Make sure calibration is within specified limits. 5. If any new adjustments are made to the knee module, make sure the new settings are stored on the mobile device as a new setting for the user. USER TRAINING Start the training after the ankle module is aligned and calibrated. Ensure full function with all connections secured. 14

15 Heel height adjustment when wearing the prosthesis If shoes are changed, then the heel height may be adjusted while the user is wearing the prosthesis. ADVISE THE USER TO FOLLOW THESE INSTRUCTIONS 1. Take a seat and ensure the prosthesis is positioned flat (heel and forefoot area) on the ground. 2. Ensure the power is on. 3. To initiate heel height adjustment, hold down the upper button and press the lower button twice (Figure 9). (The system will confirm with a beep and vibration.) 4. Heel height adjustment will start. (The system beeps and vibrates a second time.) 5. Immediately lift the prosthesis from the ground to allow for ankle adaptation! 6. The actuator will move the prosthesis into a vertical position. (The system will confirm with a beep and vibration, then LED will blink green and yellow.) 7. Heel height adjustment is complete. Note: Do not fit boots or shoes that cover the ankle area! The ankle must be able to move freely over the full range of ankle motion. To ensure proper function, do not restrict the motion of the ankle. CHARGING: Train the user on how to charge the unit. HEEL HEIGHT ADJUSTMENT: Encourage the user to switch shoes or try out barefoot walking using the heel height adjustment. CURBS: Ask the user to take a long step onto and off a curb. This will limit the ankle adaptation and prevent false ankle adaptation. Note: Walking across high curbs may initiate the stair response! SITTING: Ask the user to sit down and position the shank at over 20 relative to the ground (stretch legs). To allow for the Relax mode, the prosthesis has to be slightly unloaded. The ankle module will move into a plantar flexed position (toe down). CHAIR EXIT MODE: Ask the user, while in a seated position, to move the prosthesis under or close to the chair. ankle module will dorsiflex (toe up) to facilitate standing up. Be aware that the first step after exiting will be atypical; the foot will then adjust to walking. LEVEL GROUND: Ask the user to walk at a slow and a fast speed. Observe the dorsiflexion in swing. RAMPS: Ask the user to walk up and down on a shallow ramp and a steep ramp. Observe the ankle adaptation, and ask the user whether she/he can sense it. STAIRS: Ask the user to walk up and down on stairs. Advise him/her to lead with the prosthetic side while walking upstairs and to lead with the prosthetic side when going down. This will provide stair adaptation after the first step on stairs. Note: Instruct the user to be careful walking downstairs for the first 15

16 time, since he/she will not be used to the dorsiflexed ankle position. Encourage the user to switch shoes or try out barefoot walking using the heel height adjustment. TOE LIFT: Very slow walking speed won't trigger toe lift. HALF STEP: Sharp turns, zigzagging, or stepping up high curbs may cause dorsiflexion. POWER LOSS: The foot will return to the latest preset heel height position, and the knee module will turn off. EXTRA FUNCTIONS See Figure 9 MANUAL ANKLE OPERATION Use the upper and lower button to move the foot. If, during use, ankle motion is repeatedly restricted for any reason, the foot enters an error state and manual ankle operation is enabled automatically. An alarm will sound and the LED will blink red and yellow, with the green LED steadily on. The motor will retry three times before manual ankle operation is enabled. APPENDIX Electromagnetic Compatibility Precautions The SYMBIONIC LEG 3 needs special precautions regarding electromagnetic compatibility (EMC). Specifically it needs to be installed and put into service according to the EMC information provided as follows: The SYMBIONIC LEG 3 should not be used adjacent to or stacked with other equipment. In case adjacent or stacked use is necessary, the SYMBIONIC LEG 3 should be observed to verify normal operation in the configuration in which it will be used. The SYMBIONIC LEG 3 may be susceptible to electromagnetic interference from portable and mobile RF communications devices such as mobile (cellular) telephones. The SYMBIONIC LEG 3 may be interfered with by other equipment, even if that other equipment complies with CISPR EMISSION requirements. Guidance and Manufacturer s Declaration Electromagnetic Emissions The device is intended for use in the electromagnetic environment specified below. The customer or user of device should assure that it is used in such an environment. Emissions Test Compliance Electromagnetic Environment Guidance RF Emissions CISPR 11 Group 1 The device uses RF energy only for its internal function. Therefore, its RF emissions are low and are not likely to cause any interference in nearby electronic equipment. RF Emissions CISPR 11 Class B The device is suitable for use in all establishments, including domestic Harmonics Emissions Class B establishments and those directly IEC connected to the public low voltage power supply network that supplies Voltage Fluctuations/ Complies buildings used for domestic purposes. Flicker Emissions viec

17 Guidance and Manufacturer s Declaration Electromagnetic Emissions The device is intended for use in the electromagnetic environment specified below. The customer or user of device should assure that it is used in such an environment. Immunity Test Electrostatic Discharge (ESD) IEC Electrical fast transient/burst IEC Surge IEC Voltage dips, Short interruptions and voltage variations on power supply lines IEC Power frequency (50/60 Hz) magnetic field IEC IEC Test Level ±6 kv contact ±8 kv air ±2 kv for power supply lines ±1 kv for input/ output lines ±1 kv line(s) to line(s) ±2 kv line(s) to earth <5 % U T (>95 % dip in U T ) for 0.5 cycle. 40 % U T (60 % dip in U T ) for 5 cycles. 70 % U T (30 % dip in U T ) for 25 cycles. <5 % U T (>95% dip in U T ) for 5 s. Compliance Level ±6 kv contact ±8 kv air ±2 kv for power supply lines ±1 kv for input/ output lines ±1 kv line(s) to line(s) ±2 kv line(s) to earth <5 % U T (>95 % dip in U T ) for 0.5 cycle. 40 % U T (60 % dip in U T ) for 5 cycles. 70 % U T (30 % dip in U T ) for 25 cycles. <5 % U T (>95% dip in U T ) for 5 s. Electromagnetic Environment Guidance Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. If the user of the device requires continued operation during power mains interruptions, it is recommended that the device be powered from an uninterruptible power supply or a battery. 3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. Note: U T is the a.c. mains voltage prior to application of the test level. 17

18 Guidance and Manufacturer s Declaration Electromagnetic Emissions The device is intended for use in the electromagnetic environment specified below. The customer or user of the device should assure that it is used in such an environment. Immunity Test Conducted RF IEC Radiated RF IEC IEC Test Level 3 Vrms, 150 khz to 80 MHz 3 V/m, 80 MHz to 2.5 GHz Compliance Level 3 Vrms d=1.2 P Electromagnetic Environment Guidance Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the recommended separatvion distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance: 3 V/m d=1.2 P 80 MHz to 800 MHz d=2.3 P 800 MHz to 2.5 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey *, should be less than the compliance level in each frequency range **. Interference may occur in the vicinity of equipment marked with the following symbol: Note 1 Note 2 At 80 MHz and 800 MHz, the higher frequency range applies. These guidelines may not apply in situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. * Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur 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 device is used exceeds the applicable RF compliance level above, the device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the device. ** Over the frequency range 150 khz to 80 MHz, field strengths should be less than 3 V/m. 18

19 Recommended separation distances between portable and mobile RF communications equipment and the device. The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the 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 150 khz to 80 MHz d=1,2 P BLUETOOTH MODULES REGULATED INFORMATION This device contains the following radio frequency transmitters: m 80 MHz to 800 MHz d=1,2 P 800 MHz to 2,5 GHz d=2,3 P 0,01 0,12 0,12 0,23 0,1 0,38 0,38 0,73 1 1,2 1,2 2,3 10 3,8 3,8 7, 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 At 80 MHz and 800 MHz, the separation distance for 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. Model Bluetooth 4.2 Module: Model:BT121 Type and Frequency Characteristics FID 2402 MHz~2480 MHz (1 MHz Interval, 79 Channels) Effective Radiated Power mW/MHz USA-FEDERAL COMMUNICATIONS COMMISSION (FCC) This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses, and can radiate radio frequency energy. If not installed and used in accordance with the instructions, it may cause harmful interference to radio communications. However, there is no ensured specification that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by tuning the equipment off and on, 19

20 the user is encouraged to try and correct the interference by one or more of the following measures: Reorient or relocate the receiving antenna. Increase the distance between the equipment and the receiver. Connect the equipment to outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/tv technician for help. Any changes or modifications not expressly approved by the party responsible for compliance could void the user s authority to operate the equipment. Caution: Exposure to Radio Frequency Radiation. This device must not be co-located or operating in conjunction with any other antenna or transmitter. Canada Industry Canada (IC) This device complies with RSS 210 of Industry Canada. Operation is subject to the following two conditions: 1. this device may not cause interference, and 2. this device must accept any interference, including interference that may cause undesired operation of this device. Caution: Exposure to Radio Frequency Radiation. The installer of this radio equipment must ensure that the antenna is located or pointed such that it does not emit RF field in excess of Health Canada limits for the general population; consult Safety Code 6, obtainable from Health Canada s website 20

21 EN Caution: Össur products and components are designed and tested according to the applicable official standards or an in-house defined standard when no official standard applies. Compatibility and compliance with these standard is achieved only when Össur products are used with other recommended Össur components. If un-usual movement or product wear is detected in a structural part of a device at any time, the patient should be instructed to immediately discontinue use of the device and consult his/ her clinical specialist. This product has been designed and tested based on single patient usage. This device should NOT be used by multiple patients. If any problems occur with the use of this product, immediately contact your medical professional. 21

22 Össur Americas Össur Iberia S.L.U Towne Centre Drive Calle Caléndula, 93 - Foothill Ranch, CA 92610, USA Miniparc III Tel: +1 (949) Edificio E, Despacho M18 Tel: El Soto de la Moraleja, ossurusa@ossur.com Alcobendas Madrid España Össur Canada Tel: Graybar Road orders.spain@ossur.com Richmond, BC orders.portugal@ossur.com V6W OA5, Canada Tel: Össur Europe BV Italy Via Baroaldi, 29 Össur Europe BV Budrio, Italy De Schakel 70 Tel: GH Eindhoven orders.italy@ossur.com The Netherlands Tel: Össur APAC Tel: F, W16 B info-europe@ossur.com No Hongmei Road , Shanghai, China Össur Deutschland GmbH Tel: Augustinusstrasse 11A asia@ossur.com Frechen, Deutschland Tel: +49 (0) Össur Australia info-deutschland@ossur.com 26 Ross Street, North Parramatta Össur UK Ltd NSW 2151 Australia Unit No 1 Tel: S:Park infosydney@ossur.com Hamilton Road Stockport SK1 2AE, UK Össur South Africa Tel: +44 (0) Unit 4 & 5 ossuruk@ossur.com 3 on London Brackengate Business Park Össur Nordic Brackenfell P.O. Box Cape Town Uppsala, Sweden South Africa Tel: Tel: info@ossur.com infosa@ossur.com Össur hf. Grjótháls Reykjavík Iceland Copyright Össur 2018 TM _003 Rev. 5