instructions for use - ossur.com leg 3 instruction… · heel height adaptation the ankle of the...

Instructions for Use

Contents

FIGURES 3

DESCRIPTION OF SYMBOLS 5

ABBREVIATIONS 6

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

SYMBIONIC LEG 3 OPERATION 10

3

3 H = Full

90 min = 90%

= 0–90%

= 90–100%

= FULL

1

2

3

4

Warnings Indicates

Ankle will return to neutral (last set heel height)Approximately 2 hours left

Approximately 3 hours left



Yellow LED is solid ON

Symbionic Leg will turn OFF1x Long high pitch beep

5x beep

4x beep

3x beep

2x beep 4

Function Hold Press Beep & Vibration LED

Power – ON/OFFBlinking green & yellow2x ON

3x OFF

1x Start

1x Move

1x Complete

2x ON

3x OFF

1x ON

0x OFF

OFF

Set heel height

Solid yellow

Blinking green & yellow

–

Relax Mode – ON/OFF –

–

Sound – ON/OFF –

–

1 5

1 6

HOLD

HOLD

× × × ×

1 7

HOLD

HOLD

×/ ×/ ×

×/ ×/ ×

1 8

HOLD

PRESS2X

Warnings Indicates







5x beep

4x beep

3x beep

2x beep 4



3x OFF

1x Start

1x Move

1x Complete

2x ON

3x OFF

1x ON

0x OFF

OFF

Set heel height

Solid yellow


–


–


–

1 5

1 6

HOLD

HOLD

× × × ×

1 7

HOLD

HOLD

×/ ×/ ×

×/ ×/ ×

1 8

HOLD

PRESS2X

Warnings Indicates







5x beep

4x beep

3x beep

2x beep 4



3x OFF

1x Start

1x Move

1x Complete

2x ON

3x OFF

1x ON

0x OFF

OFF

Set heel height

Solid yellow


–


–


–

1 5

1 6

HOLD

HOLD

× × × ×

1 7

HOLD

HOLD

×/ ×/ ×

×/ ×/ ×

1 8

HOLD

PRESS2X

Warnings Indicates







5x beep

4x beep

3x beep

2x beep 4



3x OFF

1x Start

1x Move

1x Complete

2x ON

3x OFF

1x ON

0x OFF

OFF

Set heel height

Solid yellow


–


–


–

1 5

1 6

HOLD

HOLD

× × × ×

1 7

HOLD

HOLD

×/ ×/ ×

×/ ×/ ×

1 8

HOLD

PRESS2X

Warnings Indicates







5x beep

4x beep

3x beep

2x beep 4



3x OFF

1x Start

1x Move

1x Complete

2x ON

3x OFF

1x ON

0x OFF

OFF

Set heel height

Solid yellow


–


–


–

1 5

1 6

HOLD

HOLD

× × × ×

1 7

HOLD

HOLD

×/ ×/ ×

×/ ×/ ×

1 8

HOLD

PRESS2X

4

5

6 7

8

5PB

ENGLISH

DESCRIPTION OF SYMBOLS

Attention – See instructions for use

On / Off

Type B Applied Part (IEC60601-1)

CE label with Notified Body identification number

Non-ionizing radiation

Manufacturer and date of manufacturing

Direct current

Consult Instructions for use

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.

Battery status

Serial number

6

ABBREVIATIONS

Vibration feedback signal.

Auditory feedback signal „BEEP“

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

3. 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.

4. The healthcare practitioner must provide each patient with training for appropriate use and proper application of the system.

5. The user should stop walking immediately if alarm signals are felt or heard. Engage the extension lock and proceed to walk with caution.

6. The SYMBIONIC LEG 3 is designed for everyday use. The prosthesis must not be used for sports or constant high-impact activities (running, climbing, etc.).

7. The SYMBIONIC LEG 3 is battery operated and caution should be taken about exposure to water, excessive mechanical shocks or vibrations.

8. 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.

9. 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.

10. Do not use any power supply other than the one provided with the unit.

11. 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.

12. The SYMBIONIC LEG 3 may be susceptible to electromagnetic interference from portable and mobile RF communications devices such as mobile (cellular) telephones or other equipment, even if that other equipment complies with CISPR EMISSION requirements.

13. Not suitable for use in the presence of a flammable-, anesthetic mixture containing air oxygen or nitrous oxide.

14. Follow local ordinances or regulations for proper disposal of device, accessories, and packaging.

76

15. Batteries should be disposed of in accordance with local laws and regulations. They should not be incinerated.

16. 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/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.”

SYMBIONIC LEG 3 FUNCTIONS1. ANKLE FUNCTIONSDorsif lexion during swing phaseThe 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 positionAs 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 adaptationThe 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 downWith 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.

8

Standing upThe 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.

Kneeling downThe SYMBIONIC LEG 3 has the ability to plantar flex when kneeling and also when lying down.

• More natural appearance.• Enhanced comfort.

2. KNEE FUNCTIONSAutomatic 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 f luid 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 light-weight feel during swing phase.

System f lexibility 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 1

INDICATIONS FOR USELOW 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").

98

Do not:• Immerse in water or any other fluids.• Use in dirty environments.• Expose to extreme heat and/or cold

TECHNICAL SPECIFICATIONSENVIRONMENTAL

• Operating temperature: -10–40 °C (14–104 °F)• Operating humidity: 0–90% (non-condensing)• Operating atmospheric pressure: 700–1060 hPa• Shipping and storage temperature: -10 to +45 °C (14–158 °F)• Shipping and storage humidity: 5–90% (non-condensing)• Shipping and storage atmospheric pressure: 700–1060 hPa

CHARGING AND POWER

Caution: Please 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 (Figure 2).• The light on the knee module indicates the battery status while charging

(Figure 3)

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 4). 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 3 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: 0.6 A - RS• Output Voltage: 24 VDC• Output Current: 1.0 A• Operating temperature: 10–40 °C• Operating humidity: 10–90% RH (non-condensing)• Manufacturer: UE Electronic• Model No.: UE24WCP-240100SPA

10

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.

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.

SYMBIONIC LEG 3 OPERATIONPOWER ON (Figure 6)To turn on the SYMBIONIC LEG 3, 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 OFF (Figure 7)To 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.

HEEL HEIGHT ADJUSTMENT ON THE FLOOR (Figure 8)• 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 LED is solid yellow

• The actuator will move the prosthesis into a vertical position. – The system confirms with a beep and vibration.

1110

– 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.

• 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. – The LED is solid yellow.

• 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 MODERelax 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 (FIGURE 5)• To enable Relax mode, hold down the lower button and press the

upper button five times. – The system will confirm with two beeps and vibrations.

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

– The system will confirm with three beeps and vibrations.• To disable Relax mode and disable Chair Exit mode, hold down the

lower button and press the upper button 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. 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 more controlled transition from sitting to standing. The ankle will move back to neutral after the first step.

12

SOUND ON/OFF (Figure 5)To 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.

ELECTROMAGNETIC COMPATIBILITY PRECAUTIONSThe 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.

LIABILITYThe manufacturer recommends using the device only under the specified conditions and for the intended purposes. The device must be maintained according to the instructions for use. The manufacturer is not liable for damage caused by component combinations that were not authorized by the manufacturer.

COMPLIANCEThis component has been tested according to ISO 10328 standard to three million load cycles. Depending on the amputee’s activity this corresponds to a duration of use of three to five years. We recommend carrying out regular yearly safety checks

In the standard mentioned, test levels (P) are assigned to a certain maximal body masses (m in kg). In some cases, which are marked with, no test level is assigned to the product related maximal body mass. In these cases, the test

loads have been adapted adequately on the basis of the specified load level.

ISO 10328 - “P” - “m”kg *)

*) Body mass limit not to be exceeded!

For speci�c conditions and limitations of use see manufacturer’s written instructions on intended use!

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Category Össur high activity

Category Weight (Kg) Label text

1 52 P3 ISO 10328 - P3 52 kg

2 59 P3 ISO 10328 - P3 59 kg

3 68 P4 ISO 10328 - P4 68 kg

4 77 P4 ISO 10328 - P4 77 kg

5 88 P4 ISO 10328 - P5 88 kg

6 100 P5 ISO 10328 - P5 100 kg

7 116 P5 ISO 10328 - P6 116 kg

8 130 P6 ISO 10328 - P6 130 kg

• This manual is intended for use by a certified prosthetist.

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.

Össur Americas Össur Iberia S.L.U27051 Towne Centre Drive Calle Caléndula, 93 -Foothill Ranch, CA 92610, USA Miniparc IIITel: +1 (949) 382 3883 Edificio E, Despacho M18Tel: +1 800 233 6263 28109 El Soto de la Moraleja,[email protected] Alcobendas

Madrid – EspañaÖssur Canada Tel: 00 800 3539 36682150 – 6900 Graybar Road [email protected], BC [email protected] OA5 , CanadaTel: +1 604 241 8152 Össur Europe BV – Italy

Via Baroaldi, 29Össur Europe BV 40054 Budrio, ItalyDe Schakel 70 Tel: +39 05169 208525651 GH Eindhoven [email protected] NetherlandsTel: +800 3539 3668 Össur APACTel: +31 499 462840 2F, W16 [email protected] No. 1801 Hongmei Road

200233, Shanghai, ChinaÖssur Deutschland GmbH Tel: +86 21 6127 1707Augustinusstrasse 11A [email protected] Frechen, DeutschlandTel: +49 (0) 2234 6039 102 Össur [email protected] 26 Ross Street,

North ParramattaÖssur UK Ltd Sydney NSW, 2151 AustraliaUnit No 1 Tel: +61 2 88382800S:Park [email protected] RoadStockport SK1 2AE, UK Össur South AfricaTel: +44 (0) 8450 065 065 Unit 4 & [email protected] 3 on London

Brackengate Business ParkÖssur Nordic BrackenfellP.O. Box 67 7560 Cape Town751 03 Uppsala, Sweden South AfricaTel: +46 1818 2200 Tel: +27 0860 888 [email protected] [email protected]

Össur Head OfficeGrjótháls 5110 Reykjavík, IcelandTel: +354 515 1300Fax: +354 515 [email protected]

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