Instructions for Use / PatientEN

52

263,

70

235,

620

0,5

73

35,0

5

78,3

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mm

mm

mm

mm

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mm

78,3

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258,

81

235,

620

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Össur hf, Grjóthalsi 5, 110 Reykjavík, Iceland 2011

RHEO KNEERechargeable Li-Ion Battery OperatedRating: 24 V 1.0 A (max.)

123456

0086

FCC ID: PVH090103S; IC: 5325A-090103S

Flex-Foot Talux®

Elation®

Re-Flex Rotate™ with EVO™

1/3 1/3 1/3

1/2 1/2

75mm

78,3mm

52mm

56mm

= on = off

G

A

1

C D E

B

F

Vari-Flex with EVO® TM

3 H = Full

90 min = 90%

= 90-100%

= 0-90%

= FULL.........................................................................................Safety precautions.................................................................................Safety Standards And Classification.....................................................Symbionic Leg Functions......................................................................Indications For Use...............................................................................Technical specifications.........................................................................Charging and power...............................................................................Maintenance...........................................................................................Warranty.................................................................................................SYMBIONIC LEG Operation.................................................................

3466778899

2

3 H = Full

90 min = 90%

= 90-100%

= 0-90%

= FULL

2x BEEP

3x BEEP

4x BEEP

Warning Indicates

Approx. 5 hrs left

Approx. 4 hrs left

Approx. 3 hrs left

5x BEEP

1x long high pitch beep Symbionic Leg will turn o�

Approx. 2 hrs left,Ankle will return to neutral (last set heel height)Yellow LED is solid ON

90 min = 6 - 12 H

2 - 4 H = 24 - 48 H

30 min = 2 - 4 H

= on = off

= 60-90%

= 0-60%

= 90-100%

Talux® Elation®Vari-Flex®Ceterus®

B

C

A

A

C

B

D

Function

Power ON/OFF

Set heel height 2x

5x

7x

Set relax mode

Sound ON/OFF

Hold Press

3

EN - Caution: Össur products and components are designed and tested to ISO 10328. Compatibility and compliance with this standard is achieved only when Össur products and components are used with other recommended Össur or authorized com-ponents. If un-usual movement or product wear is detected in a structural part of a prosthesis 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.

4

! Consult the accompanying documents.

CE label with Notified Body indentification number

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 electronic components from other types of waste and recycle them through your local, free electronic parts return system.

Manufacturer

Date of manufacture

Non-ionizing radiation

Consult Instructions for use

"Type B Applied Part (IEC60601-1)

Auditory feedback signal "BEEP"

Vibration feedback signal.

Keypad: Lower button

Keypad: Upper button

SYMBOLS

ABBREVIATIONS:

5

1. SAFETY PRECAUTIONS

Please advise your client of information in this section.

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 loses power, the knee will NOT provide stance support and becomes a swing-only, single-axis joint.

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. For maximum safety, it is recommended that a handrail be used when descending stairs and ramps.

4. Improper adjustment of the SYMBIONIC® LEG will cause suboptimal function, which can increase the risk of falls. The SYMBIONIC® LEG must only be fitted by a clinician who has attended and passed an Össur certified SYMBIONIC® LEG education program.

5. When making adjustments to the SYMBIONIC® LEG, 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 is designed for everyday use. The prosthesis must not be used for sports or constant high-impact activities (running, climbing, etc.).

9. The SYMBIONIC LEG 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. 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. Do not use any power supply other than the one provided with the unit.

13. Do not use in highly electrical and/or magnetic environments (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.

17. Caution should be taken with respect to the use of the SYMBIONIC LEG 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 off (see chapter Power OFF).

Caution: Federal law requires this device to be sold by a prosthetist and on the order of a physician.

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2. SAFETY STANDARDS AND CLASSIFICATION

The SYMBIONIC® LEG is tested and certified to comply with the IEC/EN60601-1 standard for electrical safety of medical devices, the IEC/EN60601-1-2 standard for electromagnetic compatibility for medical electrical devices, and ISO 10328. The company fulfills the requirements of ISO 13485. 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.”

3. SYMBIONIC® LEG 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 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 will plantar flex in sitting ( it is off by default).• More natural appearance.

• Enhanced comfort.

STANDING UP

The ankle of the SYMBIONIC LEG assists in standing up from a seated position through an adaptation of its ankle position.

• More controlled transition from sitting to standing.

KNEELING DOWN

The SYMBIONIC LEG has the ability to plantar flex when kneeling and also when lying down.• More natural appearance.

• Enhanced comfort.

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2. KNEE FUNCTIONS

MICROPROCESSOR CONTROLLED STANCE PHASE RESISTANCE.

Assists the user in maintaining knee stability on a variety of surfaces. • Increases security and confidence

• Reduces conscious effort of and stress on user to maintain knee stability

ADJUSTABLE STANCE FLEXION

Provides adjustable stance resistance for varying degrees of knee flexion during loading response. • Shock absorption

• Natural gait dynamic

ADJUSTABLE STANCE EXTENSION

Provides adjustable stance resistance to knee extension between loading response and midstance. • Increases comfort by dampening extension force and allowing shock absorption

• Natural gait dynamic

MICROPROCESSOR CONTROLLED SWING PHASE RESISTANCE

Samples and adjusts to the user’s walking speed during swing at a rate of 1000 times per second (1000Hz). Allows the user to achieve comfortable and symmetric transitions between a wide range of walking speeds.

• Improves gait symmetry

• Improves gait efficiency

• Enhances comfort

MAGNETORHEOLOGIC (MR) FLUID ACTUATOR

Magnetized fluid provides frictional resistance to flexion and extension movement. • Zero-pressure actuator has potential for long lifetime of use and low maintenance requirements

• Actuator weight is located more proximal in the knee, providing a lightweight feel during swing phase Very low torque production during swing phase; allows for easy initiation of swing flexion

4. INDICATIONS FOR USE

The SYMBIONIC LEG is a microprocessor controlled leg, composed of an adaptive knee joint and a powered ankle. The SYMBIONIC LEG is designed for patients with transfemoral and knee disarticulation amputation. The healthcare practitioner must provide each patient with training for appropriate use and proper application of the system.

• Low to moderate impact only.

• Community and workplace ambulators with ability or potential for cadence variation and ramp/stair descent.

• Examples: shopping, gardening, longer walks, golfing

• Weight limit: 125kg (275lbs)

• Knee center to floor should be greater than or equal to 40cm (approximately 16’’)

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5. TECHNICAL SPECIFICATIONS

ENVIRONMENTAL• Operating temperature: -10 - 40°C (14 - 104°F)

• Operating humidity: 0–90% (non-condensing)

• Operating atmospheric pressure: 700 hPa – 1060 h

• Shipping and storage temperature: -10 - 45°C (14 - 158°F)

• Shipping and storage humidity: 0 - 90% (non - condensing)

• Shipping and storage atmospheric pressure: 700 hPa - 1060 hPa

6. CHARGING AND POWER

CAUTION: Please take the prosthesis off prior to charging.

• The SYMBIONIC LEG should be charged daily for optimal performance.

• It is not possible to overcharge the SYMBIONIC LEG.

• In order to ensure full battery charge, it is recommended to turn the SYMBIONIC LEG OFF while charging (Figure A).

• Insert the charger cable into the charging port on the user interface panel off the knee module (Figure B).

Note: The KNEE MODULE does not indicate charging status. The yellow light on the ankle unit blinks when charging and becomes solid when full.

BATTERY CAPACITYFully charged battery is sufficient for 16–24 hours of continuous use, depending on activity.

WARNING SIGNALS FOR POWER LOSSVibratory 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 C). 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. Prepare for immediate power loss.

The SYMBIONIC LEG should not be used when the power is off.

POWER SUPPLY• Power input: An external power supply for medical use.

• Input: 100 - 240 VAC

• Input frequency: 50 - 60 HZ

• Input current: 0.6A - RS

• Output Voltage: 24 VDC

• Output Current: 1.0 A

• Operating temperature: 0 - 40°C

• Operating humidity: 10 - 90% RH (non-condensing)

• Manufacturer: UE Electronic

• Model No.: UE24WCP-240100SPA

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7. MAINTENANCE

DO NOT disassemble the SYMBIONIC LEG, remove the battery pack or attempt repairs as this may create a user hazard and will automatically void warranty. After talking with your healthcare provider to ensure you are following the operating instructions properly, 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 be inspected every six months by a qualified professional. Check for signs of unusual wear.

CLEANING• Clean the SYMBIONIC LEG 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, as it can cause the prosthesis to malfunction and deteriorate prematurely.

8. WARRANTY

See Terms of Warranty for details.

9. SYMBIONIC® LEG OPERATION

POWER ONTo turn on the SYMBIONIC LEG, hold both buttons for at least one second. The system will confirm with two beeps and vibrations. The LED will blink green and yellow.

NOTE: The keypad will be disabled 60 seconds after use.

To enable the keypad, hold both buttons for at least one second.

POWER OFFTo enable the keypad, hold and press both buttons for at least one second.

To power off, hold and press both buttons for at least one second.* The system will confirm with three beeps and three vibrations.

* The LEDs turn off.

HEEL HEIGHT ADJUSTMENT - ANKLE MODULEThe ankle module can be adjusted for variable heel height. The heel height adjustment ensures correct alignment of the prosthesis.

Hold

Hold

3x

3x

Hold

Hold

2x

2x

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HEEL HEIGHT ADJUSTMENT ON THE FLOOR • 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 .

NOTE: Pay attention to the audible feedback.

* The system confirms with a beep and vibration.

• Heel height adjustment will start.

* The system beeps and vibrates a second time.

• The actuator will move the prosthesis into a vertical position.

* The system confirms with a beep and vibration.

* The LED blinks green and yellow.

• Heel height adjustment is complete.

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.

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:• Take a seat and ensure the prosthesis is positioned flat (heel and forefoot area) on the ground.

• Ensure power is on and the keypad is enabled

• To initiate heel height adjustment, hold down the upper button and press the lower button twice.

* The system confirms with a beep and vibration

• Heel height adjustment will start.

* The system beeps and vibrates a second time.

• Immediately lift the prosthesis from the ground to allow for ankle adaptation!

• The actuator will move the prosthesis into a vertical position.

* The system confirms with a beep and vibration.

* The LED blinks green and yellow.

• Heel height adjustment is complete.

RELAX MODE / CHAIR EXIT MODE 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. • To enable Relax mode, hold down and press five times.

* The system will confirm with two beeps and vibrations.

• To disable Relax mode and enable Chair Exit mode only, hold down and press five times.

* The system will confirm with three beeps and vibrations.

• To disable Relax mode and disable CHAIR EXIT MODE, hold down and press five times.

* The system will confirm with a single beep and vibration.

• Initiate Relax mode in a sitting position by extending the knee for at least 2 seconds.

Hold

Press2x

1x1x1x

1x/1x/1x

11

* 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: • Tap the heel of the foot.

• 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 more controlled transition from sitting to standing. The ankle will move back to neutral after the first step.

SOUND ON/OFFTo enable or disable auditory feedback, hold down the lower button and press the upper button seven times. The system will confirm with a beep and vibration when enabled.There is no confirmation when sound is disabled.

10. SAFETY PRECAUTIONS

APPENDIX 1: ELECTROMAGNETIC COMPATIBILITY PRECAUTIONS

The SYMBIONIC® LEG 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 should not be used adjacent to or stacked with other equipment. In case adjacent or

stacked use is necessary, the SYMBIONIC LEG should be observed to verify normal operation in the configuration in which it will be used.

• The SYMBIONIC LEG may be susceptible to electromagnetic interference from portable and mobile RF communications devices such as mobile (cellular) telephones.

• The SYMBIONIC LEG may be interfered with by other equipment, even if that other equipment complies with CISPR EMISSION requirements.

Emissions Test Compliance Electromagnetic Environment - GuidanceThe SYMBIONIC LEG uses RF energy only for its internal function. Therefore, it’s RF emissions are low and are not likely to cause any interference in nearby electronic equipment.

The SYMBIONIC LEG is suitable for use in all establishments including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Group 1

Class B

Class A

Complies

RF EmissionsCISPR 11

RF EmissionsCISPR 11

Harmonics EmissionsIEC 61000-3-2

Voltage Fluctuations/Flicker Emissions IEC 61000-3-33

Guidance and Manufacturer’s Declaration – Electromagnetic Emissions

The SYMBIONIC® LEG is intended for use in the electromagnetic environment specified below. The customer or user of SYMBIONIC® LEG should assure that it is used in such an environment.

Immunity Test IEC 60601 Test Level Compliance Level ElectromagneticEnvironment Guidance

+/- 6 kV contact+/- 8 kV air

+/- 1kV for input/output lines +/-2kV for power supply lines

3 A/m

<5% UT (>95% dip in UT) for 0.5 cycle40% UT(60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for25 cycles <5% UT (>95% dip in UT) for 5 sec.

+/- 1 kV line to line+/- 2 kV line to earth

+/- 6 kV contact+/- 8 kV air

+/- 1kV for input/output lines+/-2kV for power supply lines

3 A/m

<5% UT (>95% dip in UT) for 0.5 cycle40% UT (60% dip in UT) for 5 cycles 70%UT (30% dip in UT) for25 cycles <5% UT (>95%dip in UT) for 5 sec.

+/- 1 kV line to line+/- 2 kV line to earth

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 clinical environment.

Power frequency magnetic fields should be at levels characteristic of a typical location in 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

Electrostatic Discharge (ESD) IEC 61000-4-2

Electrical fast transient/burst IEC 61000-4-4

Power frequency (50/60Hz)magnetic field IEC 61000-4-8

Voltage dips, Short interruptions and voltage variations on power supply lines IEC 61000-4-11

Surge IEC 61000-4-5

Guidance and Manufacturer’s Declaration – Electromagnetic ImmunityThe SYMBIONIC® LEG is intended for use in the electromagnetic environment specified below. The customer or user of SYMBIONIC® LEG should assure that it is used in such an environment.

3 V(rms) 150 kHz to 80 MHz

3 V/m 80 MHz to2.5GHz

3 V/m

Conducted RF IEC 61000-4-6

Radiated RF IEC 61000-4-3

NOTES: 1. UT is the a.c. mains voltage prior to application of the test level.2. Bluetooth RF Receptor / Transmitter Information:

• Frequency band of reception and transmission: 2,402 to 2,480MHz • Modulation type: GFSK modulator (Bluetooth basic rate (BR)) • Effective radiated power: 3 dBm maximum (Power Level II)

3 V(rms)

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