Instructions for use
www.ossur.com
TABLE OF CONTENTS
1 INTRODUCTION.......................................................................................................4
1.1
1.2
1.3
1.4
1.5
1.6
1.7
1.8
FOREWORD......................................................................................................................... 4
INTENDED USE................................................................................................................... 4
SAFETY SYMBOLS USED IN THIS MANUAL ................................................................... 4
User safety............................................................................................................................. 4
Product precaution................................................................................................................ 4
Note...................................................................................................................................... 4
SYMBOLS USED ON THE EQUIPMENT............................................................................5
PRODUCT LABELING...........................................................................................................5
GENERAL SAFETY INSTRUCTIONS.................................................................................. 6
INDICATIONS FOR USE..................................................................................................... 6
CONTRAINDICATIONS FOR USE...................................................................................... 6
2 GENERAL................................................................................................................... 7
2.1
2.2
DESCRIPTION OF EQUIPMENT........................................................................................ 7
HOW THE PROSTHESIS WORKS...................................................................................... 8
3 PREPARING YOUR PROSTHESIS FOR USE............................................................9
3.1
3.2
3.3
3.4
CHECK LIST......................................................................................................................... 9
PREPARING THE APM........................................................................................................ 9
TURNING ON THE APM.................................................................................................. 10
TURNING ON AND CALIBRATING THE PROSTHESIS................................................. 10
4 OPERATION............................................................................................................ 10
4.1
4.2
4.3
4.4
4.5
4.6
4.7
4.10
4.11
4.12
4.13
4.14
4.15
2
SITTING DOWN................................................................................................................. 11
STANDING UP................................................................................................................... 11
WALKING ON A LEVEL SURFACE OR RAMP (MAX. 7°).................................................12
ASCENDING OR DESCENDING A RAMP (MAX. 15°).....................................................12
ASCENDING STAIRS.......................................................................................................... 13
DESCENDING STAIRS....................................................................................................... 13
WHAT IF…?.........................................................................................................................14
The prosthesis behaves abnormally...................................................................................... 14
You still feel insecure operating the prosthesis....................................................................... 14
LOCKING THE PROSTHESIS.......................................................................................... 15
To lock the prosthesis............................................................................................................ 15
To unlock the prosthesis........................................................................................................ 15
USER INFORMATION......................................................................................................16
Audible warning (beep sound)..............................................................................................16
Vibrator................................................................................................................................16
Visual warning (LED lights).................................................................................................16
PROSTHESIS/APM COMMUNICATION........................................................................17
BATTERY POWER..............................................................................................................17
AFTER USE........................................................................................................................17
CHARGING THE PROSTHESIS AND APM BATTERIES.................................................17
Connections......................................................................................................................... 17
Battery charge......................................................................................................................18
After charging.......................................................................................................................19
5 MAINTENANCE....................................................................................................... 19
5.1
5.2
5.3
5.4
PROSTHESIS.......................................................................................................................19
Daily maintenance...............................................................................................................19
Scheduled maintenance...................................................................................................... 20
APM AND BATTERY CHARGER........................................................................................ 20
TECHNICAL DATA............................................................................................................. 20
TRANSPORT AND STORAGE CONDITIONS...................................................................21
6 WARRANTY............................................................................................................. 21
7 PRODUCT CERTIFICATION INFORMATION........................................................ 21
3
1 INTRODUCTION
1.1 FOREWORD
We would like to thank you for the confidence you have put in the POWER KNEE™ system.
This next generation of prosthetic solution for above-knee amputees was developed to allow
you to perform unprecedented function and should help you explore new functional opportunities after due training and adaptation.
We urge you to read this manual thoroughly and to discuss any questions you may have with
your CPO (certified prosthetist-orthotist) before using your prosthesis. To ensure safe and
proper operation of the equipment, you must correctly follow all instructions provided in this
manual and respect specified limitations. Please note that the POWER KNEE™ motorized
prosthesis has been fitted to your personal specifications and is not interchangeable with any
other motorized prosthesis nor resellable to any other party.
Using your prosthesis safely depends upon your diligence in following all instructions in
this manual as well as upon your good judgment and/or common sense. Össur hf. is not
responsible for injuries and/or damage resulting from any user’s personal failure to follow
the instructions in this manual or to exercise good judgment and/or common sense.
Although we feel confident that this manual will usefully instruct you on how to safely and
effectively use your prosthesis in day-to-day operating conditions, we invite you to submit
through your CPO any corrections, remarks, or comments you feel may be useful to improve
the following information.
We are convinced you will find the POWER KNEE™ to your complete satisfaction for a
number of years!
1.2 INTENDED USE
The POWER KNEE™ is designed for subjects with transfemoral (above-knee) amputations
who are already familiar with the operation of passive, conventional prostheses.
1.3 SAFETY SYMBOLS USED IN THIS MANUAL
The symbols below are used in this manual to identify safety warnings and product precautions. It is very important that you read and understand them completely before using your
prosthesis for the first time.
4
User safety
Refers to a potential personal hazard. Failure to heed this warning may result in bodily harm or injury.
Product precaution
Note
Refers to any information regarding the operation or handling of the product which should not be overlooked.
Refers to a potential product hazard. Failure to heed this caution may result in damage to the product.
1.4 SYMBOLS USED ON THE EQUIPMENT
Prosthesis
Read operating
instructions
0086
CE label with
Notified Body
identification No.
APM module &
orthesis (insole)
0086
CE label with
Notified Body
identification No.
Battery charger
Read operating
instructions
0086
CE label with
Notified Body
identification No.
CSA label
On-Off switch
1.5 PRODUCT LABELING
5
1.6 GENERAL SAFETY INSTRUCTIONS
User safety
You are expected to practice operating your motorized prosthesis in the presence of a
trained attendant (CPO or specially trained care professional) before using it in a dailyliving environment.
Always exercise good judgment and common sense when using your prosthetic leg system (including the battery charger), limit its utilization to the use it was designed for, and
follow the instructions provided in this manual.
Never attempt to open or modify any component of the prosthetic leg system in any way.
Always keep all components of the prosthetic leg system (including the battery charger)
away from direct contact with water. The battery charger is for indoor use only.
Make sure that no component of the prosthetic leg system (including the battery charger)
has been altered or tampered with.
When the prosthesis is turned off or loses power, it will operate in passive mode, providing little or no support. You should be very familiar with your prosthesis before using it in
passive mode.
Keep fingers away from the back side of the prosthesis joint to prevent the risk of pinching in the event of accidental flexion.
Always proceed with a visual inspection of the prosthesis before use.
Refrain from using the prosthesis if you are below 60 kg (132 lb) or above 90 kg (198 lb)
to avoid affecting system performance.
Power up the prosthesis only when you are wearing it.
Avoid close proximity of the prosthesis to microwave ovens, cellphones, wireless phones,
etc. in operation, or near any other devices that use Wi-Fi™ or Bluetooth™ communication technology.
If you experience any problems with a component of the prosthetic leg system (including
the battery charger) that are not documented in this manual, contact your CPO. Never
attempt to make any technical repairs yourself.
Product precautions
Avoid exposure to rain, snow, ice, or salt. Maintain and store in a clean and dry condition.
Use the prosthesis at temperatures between –10°C and +40°C.
Avoid subjecting any component of the prosthetic leg system to excessive mechanical
shocks or vibrations.
Follow recommended maintenance intervals.
1.7 INDICATIONS FOR USE
Community and workplace ambulators already familiar with the operation of passive, conventional prostheses, with ability or potential for cadence variation and ramp/stair ascent/descent (K3 functional ambulation level). Low to moderate impact only.
1.8 CONTRAINDICATIONS FOR USE
Any conditions contrary to the above-listed indications for use and/or to any of the guidelines
expressly stated in this manual.
6
2 GENERAL
2.1 DESCRIPTION OF EQUIPMENT
Figure 1 – Overview of the prosthesis
Motorized
module
Transtibial post
& rubber cover
Prosthetic foot
Note
Equipment may not be exactly as shown.
1. The prosthetic system, or “prosthesis” for short, consists of the following:
Rubber socket cover: Rubber cover that protects the socket (socket is not shown in this manual).
Motorized module: The core of the system. The motorized module consists of the actuator, the I/O unit, and the power supply module and is protected by a front and rear hood that are not to be removed.
Transtibial post: Connects the prosthetic foot to the motorized module. The
transtibial post is protected by a rubber cover.
Prosthetic foot: Equipped with the same flat-bottomed shoe as the sound foot as well as a foot shell (foot shell is not shown in this manual).
2. The system can be activated once it is in communication with the APM:
Figure 2 – APM
APM
APM: Establishes a wireless communication link between your sound leg and the motorized module so that it can define prosthesis behavior.
7
3. The APM is connected to the orthesis (insole) via a connector cable:
Figure 3 – Orthesis with connector cable
Orthesis
Orthesis: Fits into the shoe of the sound foot. The orthesis is equipped with
pressure sensors that transmit data to the motorized module via the APM.
4. The prosthesis and APM are charged using a battery charger:
Figure 4 – Battery charger
Battery charger
Battery charger: Used to charge the batteries of the prosthesis and APM.
2.2 HOW THE PROSTHESIS WORKS
Once the APM is attached to the shin bone of your sound leg, the prosthesis is able to detect
and “imitate” the movements of the opposite leg, copying your locomotion pattern and
helping you obtain as natural a gait as possible. Unlike conventional prostheses, the motorized prosthesis is said to be “active,” as it is designed to reproduce the movements of the
amputated lower limb in an independent and dynamic fashion.
Three LED lights (two on the prosthesis and one on the APM) and an audible alarm emitted by the prosthesis as well as a vibrator provide information on the operating status of
the prosthetic leg system. During normal operation, a beep from the prosthesis indicates a
warning and prompts you to stop walking immediately, while a vibration indicates an APM
problem that limits the use of the prosthesis to the current function.
8
3 PREPARING YOUR PROSTHESIS FOR USE
3.1 CHECKLIST
1. Has no component of the prosthetic leg system been altered or tampered with?
2. Does the prosthesis appear to be in good working order (protective hoods and attachment screws in place, etc.) upon visual inspection, is it tightly fixed to the socket, and is the prosthetic foot secured into place?
3. Is the swing movement perfectly smooth in its full range when you flex the
prosthesis?
4. Can the prosthesis be locked properly?
5. Have comfort insoles been removed both from the shoe of your sound foot and the
prosthetic foot, is the orthesis firmly in place, and are you wearing a pair of socks to
avoid direct skin contact with the APM on the shin of your sound leg and with the
orthesis?
6. Have the prosthesis and APM batteries been charged?
3.2 PREPARING THE APM
1. Plug the orthesis connector (“HRS” mark facing up) into the APM until you hear a click.
Figure 5 – APM connection
Blue LED
On/Off Button
Connector
2. Strap the APM firmly around the lower part of the shin of your sound leg so it is facing the prosthesis. The connector cable should be neither too loose nor too tight. Make sure that you never pull on the cable. Make sure the APM is placed on the inside of the leg above the ankle.
Figure 6 – APM positioning
9
3.3 TURNING ON THE APM
1. Turn on the APM.
2. The blue LED lights up, indicating that the APM is ready to establish communication with
the prosthesis.
3.4 TURNING ON AND CALIBRATING THE PROSTHESIS
1. Turn on the prosthesis. The green LED lights up. The prosthesis is now ready to support
your weight.
Figure 7 – LEDs and on/off button
On/Off Button
Green LED
Blue LED
2. Good communication between the prosthesis and APM is indicated by both blue LEDs
blinking once per second.
3. A one-tone beep indicates a high prosthesis battery level, a two-tone beep indicates a
medium battery level, while a three-tone beep indicates a low battery level.
Calibration
Note
10
{
The system must be calibrated every time it is turned on, within 1 minute after
power-up. Until calibrated properly, prosthesis use will be impaired and limited to
level walking.
Calibration
{
4. Take three steps forward at your normal gait, starting with your sound leg.
5. If the prosthesis continues to vibrate, stop walking, turn the prosthesis and APM
off then on again, and take three more steps forward as explained above until
calibration has been successfully completed. If you feel no vibration, the system
has been successfully calibrated and is now ready for use.
4 OPERATION
The prosthetic system operates by detecting the movement of your sound leg and reproducing the same movement in the prosthesis at the desired cadence. The pressure sensors
in the orthesis (inside the shoe of the sound foot) collect data and send it to the APM for
processing. That is why the system is fully operational only when the prosthesis and APM are
in active communication.
Practise using your prosthesis until you are fully comfortable with each of the functions described below and have your CPO fine-tune all adjustments for maximum personal comfort
and optimal system performance.
The prosthesis is said to be stable when none of the functions described below has been
detected. The prosthesis is then in an extended position and can support your weight, while
having a certain degree of flexibility.
4.1 SITTING DOWN
1. Keep your body weight on both heels.
2. Bend both legs simultaneously and feel how the prosthesis supports you while lowering
down.
3. Once the prosthesis reaches a given flexion angle or 0.5 second after you have reached
the sitting down position, the prosthesis will automatically relax. Keep load on the prosthesis to avoid premature extension.
Figure 8 – Sitting down
4.2 STANDING UP
1. Lean slightly forward and place the forefoot of the prosthesis on the ground, using your
hand to help bend the prosthesis if necessary.
2. Place your weight on both your sound leg and the prosthesis to start standing and feel
how the prosthesis assists you while standing up.
3. If you want to sit down again, stop the knee extension for approx. 0.5 second so the knee
becomes passive.
Figure 9 – Standing up
11
4.3 WALKING ON A LEVEL SURFACE OR RAMP (MAX. 7°)
1. Take the first stride with your sound leg and make sure that the heel touches the ground
first.
2. Bring the hip forward as the prosthesis lifts off the ground and swings forward.
3. Walk at your convenient walking speed and the prosthesis will adjust accordingly.
☛
Tip: To enhance the system’s ability to detect a halt in movement, place your sound foot flat on the ground and avoid ground contact with the prosthesis for at least 0.5 second until the “stable” position is detected. The prosthesis can then support your weight.
Figure 10 – Walking on a level surface or ramp (max. 7º)
4.4 ASCENDING OR DESCENDING A RAMP (MAX. 15°)
1. Proceed as described above.
2. Steep ramp walking is automatically detected at a specific inclination level depending
on your personal walking style, generally at around 12°. It may take a few steps before the
prosthesis adjusts accordingly.
Figure 11 – Ascending a ramp
Figure 12 – Descending a ramp
12
4.5 ASCENDING STAIRS
1. Before ascending stairs, you must come to a complete stop.
2. Take the first step up with your sound leg. Hit the step with the forefoot of your sound leg.
Tip: To enhance the system’s ability to detect stair ascent, exaggerate lifting of the sound foot on the first step, bring your body weight forward to the sound side, and take a bigger step.
3. Hit the next step with the forefoot of the prosthesis and transfer your weight onto the
prosthesis. Feel how the prosthesis assists you up and make sure to keep your balance.
Keep ascending stairs at your convenient walking speed and the prosthesis will adjust ac
cordingly. Always hit the step with the forefoot of your sound leg.
4. To stop, place your sound foot flat on the ground and avoid ground contact with the pros
thesis for at least 0.5 second until the “stable” position is detected. The prosthesis can then
support your weight.
5. To transition immediately from stair ascending to level or ramp walking, simply reduce
speed when reaching the end of the stairs and hit the last step with the heel of your sound
leg. The prosthesis will then detect level ground walking and behave accordingly.
Figure 13 – Ascending stairs
☛
4.6 DESCENDING STAIRS
1. Before descending stairs, you must come to a complete stop.
2. Start descending by hitting the first step with the heel of the prosthetic foot.
3. Transfer your body weight onto the prosthesis. This will perform a controlled flexion assisting you down the next step.
4. Bring the sound side forward and place the forefoot of your sound leg on the next step.
The prosthesis will bend and actively swing forward to the next step. Feel how the
prosthesis supports you. Keep descending stairs at your convenient walking speed and
the prosthesis will adjust accordingly.
5. To stop, place your sound foot flat on the ground and avoid ground contact with the
prosthesis for at least 0.5 second until the “stable” position is detected. The prosthesis
can then support your weight.
6. You can transition immediately from stair descending to level or ramp walking:
If you reach the bottom of the stairs with your prosthetic leg first, take a very short step with your sound leg heel-first.
If you reach the bottom of the stairs with your sound leg first, put your foot on the ground heel-first and take a long stride to swing the prosthesis more easily off the last step.
13
Figure 14 – Descending stairs
User safety
Avoid walking on steep slopes. Instead, try to use standard ramps designed for people with limited mobility.
Always use the bannister or handrail when walking on ramps or stairs.
Stop walking immediately whenever you hear the prosthesis beep or encounter unexpected behavior from the prosthesis, and determine whether stance control is present.
Note
When no prosthesis movement or ground contact has been detected for an unexpectedly long period of time, the prosthesis goes into a “stable” state, where it
is extended and immobile. It can still support your weight, while having a certain
degree of flexibility. If this unexpected period of time without ground contact with
the prosthesis occurs in the “stable” position, no other function can be initiated automatically at the next foot strike.
4.7 WHAT IF... ?
The prosthesis behaves abnormally
Functions are incorrectly detected. Proceed as follows:
1. Stand still and keep your sound foot flat on the ground, avoiding ground contact with the
prosthesis and immobilizing your sound leg for at least 0.5 second.
2. If the problem persists, turn the prosthesis and APM off then on again and calibrate the
system.
You still feel insecure operating the prosthesis
Contact your CPO and consider extending your training.
14
4.10 LOCKING THE PROSTHESIS
Locking the prosthesis ensures that the system is mechanically immobilized in the extended
position. Lock the prosthesis whenever a problem arises. Before you lock your prosthesis,
however, be sure to turn it off.
In the event of a failure (e.g., depleted battery), the prosthesis will operate in passive mode,
being inert and providing no support. You should be very familiar with your prosthesis before
using it in passive mode. Depending on your experience level with the system, you may prefer to continue walking without locking the prosthesis.
User safety
Always be aware of your safety and lock the prosthesis when in passive mode to reduce the risk of falling.
TO LOCK THE PROSTHESIS
1. Place the prosthesis in hyperextended position (once you have fully extended the
prosthetic leg, push the prosthetic knee backward to force the extension movement
slightly).
2. Push the locking pin as far as it will go to the left until it locks into place. The locking pin
is just beside the knee joint axis of the prosthesis.
Figure 15 – Locking/unlocking the prosthesis
To unlock
Locking pin (shown
in locked position)
To lock
Rear view
TO UNLOCK THE PROSTHESIS
1. Place the prosthesis in hyperextended position as explained above.
2. Push the locking pin as far as it will go to the right. The prosthesis joint can now move
freely.
15
4.11 USER INFORMATION
Operation-related information is provided in the form of an audible signal or vibration emitted
by the prosthesis and/or by a visual indication from the blue LED on the prosthesis or APM.
AUDIBLE WARNING (BEEP SOUND)
Problem with the prosthesis.
VIBRATOR
Problem with the APM.
VISUAL WARNING (LED LIGHTS)
PROSTHESIS
Green LED: indicates the prosthesis is on. Blue LED: identifies the operation status or problem.
APM
Blue LED: indicates the APM is on and identifies the operation status or problem.
Table 1 – Quick warning chart
Symtom
Cause
Prosthesis
vi-brates. Blue LED
remains lit.
Communication
failure.
Prosthesis beeps
twice every minute.
Blue LED blinks.
1st level
warning*. Caution!
Be aware of an
abnormal condition.
Prosthesis beeps
2nd level warning*.
repeatedly. Blue LED Stop walking
blinks.
immediately and try
to fix the problem
without delay.
Prosthesis beeps a
few seconds
continuously, then
at regular intervals.
Blue LED blinks.
Fatal error*.
Prosthesis operates
in passive mode and
will shut down after
2 minutes. Stop
walking immediately
and try to fix the
problem.
* May be low battery !
If any other problem occurs:
1. Stop walking immediately, and lock the prosthesis if necessary.
2. Check the equipment.
3. Unlock the prosthesis, then reset the prosthesis and APM and make a calibration.
4. If the problem persists, take note of the beep rate and/or blue LED condition and contact
your CPO.
16
4.12 PROSTHESIS/APM COMMUNICATION
During normal communication, both blue LEDs on the prosthesis and APM blink once per
second. When communication is interrupted, they remain permanently lit and the prosthesis
vibrates at each step. The APM then goes into stand-by mode and the prosthesis continues
to operate in the current function. If communication is not reestablished within 5 minutes,
the APM automatically shuts down.
When the APM turns off during a specific function, the prosthesis continues to operate in
its current function and no other function can be initiated automatically. When walking level
ground without the APM it is recommended not to walk down stairs or inclines. Walking
upstair and up inclines is not possible without APM.
4.13 BATTERY POWER
In the event that the prosthesis battery power drops below a certain level, three types of
audible/visual warnings are emitted according to the level of battery depletion. Whenever you
hear the first-level warning, however, you should reduce prosthesis use to a minimum (walking on level ground only) and charge the battery as soon as possible.
4.14 AFTER USE
1. Once you have finished using your prosthesis, turn it off (it then beeps), then turn off the
APM.
Product precaution
Always turn off the APM before disconnecting the insole.
2. Disconnect the insole connector cable from the APM by pressing firmly on the two lock
tabs on both sides of the connector.
3. Charge the prosthesis and APM batteries.
4. Store your prosthesis and accessories in a safe, clean place.
Product precaution
If the prosthesis is not in use for an extended period of time, the batteries may have to be charged prior to use.
4.15 CHARGING THE PROSTHESIS AND APM BATTERIES
Charge the prosthesis and APM batteries every time the equipment is subject to intensive
use, ideally at the end of the day so it is fully charged and operational the next day.
The prosthesis and APM batteries can be charged separately or simultaneously at
temperatures ranging from 0˚C to +40˚C.
The battery charger is compatible only with the POWER KNEE™ prosthesis and APM and
is equipped with a universal internal power supply. Use the proper power cord matching
the equipment specifications.
Connections
Product precaution
Before connecting any cables, make sure that the prosthesis, APM, and battery charger are turned off.
1. Plug the prosthesis charger cable into the prosthesis connector until you hear a click.
Make sure to align the red dot on the connector sleeve with the slot on the prosthesis
connector.
2. Plug the APM charger cable (“HRS” mark facing up) into the APM until you hear a click.
3. Plug the battery charger power cord into the receptacle at the back of the charger and into
a wall outlet.
17
User safety
Never use an extension cord to plug in the battery charger. Plug the charger directly into a properly wired standard wall outlet.
Never use the prosthesis while it is connected to the battery charger. The
prosthesis will automatically turn off as soon as the prosthesis charger cable is plugged into the prosthesis connector.
If the prosthesis or APM batteries become frozen, do not attempt to charge them. Cold or frozen batteries should be allowed to warm up prior to charging.
Figure 16 – Battery charger connections
Connector
slot
APM charger
cable
Prosthetic
charger cable
Red dot
Power cord
receptacle
On/Off switch
BATTERY CHARGE
1. Turn on the charger. The “Power” LED ( ) lights up.
2. The battery charge starts automatically. The green “Prosthesis” or “APM” LED blinks
quickly to indicate that the battery is being charged. When the battery charge is nearly
completed, the LED blinks more slowly.
3. Once the prosthesis or APM battery is fully charged, the LED remains lit.
Figure 17 – Battery charger LEDs
APM LED
(green/yellow/red)
Fault LED (red)
Power LED (green)
Prosthesis LED
(green/yellow/red)
18
Product precautions
Only charge the prosthesis and APM batteries when the units are turned off.
Try to always fully charge the prosthesis and APM batteries after use. Fully charged batteries improve global performance and extend battery lifetime.
Ensure that the battery charger air vents are unobstructed at all times to allow the device to cool when in operation.
Notes
When the prosthesis and APM batteries are completely depleted, they typically take about three and two hours to charge respectively.
If a problem is detected when charging the prosthesis or APM battery, a yellow LED will light up. In the event of a fatal malfunction, a red LED will light up. Try charging the batteries again. If the problem persists, contact your CPO.
The prosthesis and APM batteries have no “memory effect”, i.e., they can be charged before they are completely discharged.
Short battery charging/discharging cycles are a sign of worn or defective batteries. Contact your CPO.
After charging
1. Turn off the charger.
2. Disconnect the APM charger cable by pressing firmly on the two lock tabs on both sides
of the connector.
3. Disconnect the prosthesis charger cable by holding the connector firmly (not the cable!),
then close the rubber connector cap.
Figure 18 – Prosthesis connector cap
Rubber
connector cap
5 MAINTENANCE
5.1 PROSTHESIS
Daily maintenance
There are no user-serviceable components in your POWER KNEE™ prosthesis. Just ensure
that it remains in good outward condition. Clean the surface of the prosthesis with a soft
damp cloth on a regular basis and if necessary disinfect with a regular health care disinfectant. Also, since the prosthesis has been specially assembled and adjusted for your personal
specifications, do not try to make any adjustments yourself. If need be, contact your CPO,
who will make any necessary adjustments for you.
19
Scheduled maintenance
Prescribed maintenance interval is once per year for heavy maintenance. See the POWER
KNEE™ Warranty Card with regard to the maintenance of your motorized prosthesis.
APM and battery charger
The POWER KNEE™ APM and battery charger are maintenance-free. Just ensure that they
remain in good outward condition and clean their surface with a soft damp cloth on a regular
basis.
Technical data
Table 2 – POWER KNEE™ technical data
Prosthesis
Class of user
K3 functional ambulation level as per
HCPCS classification, 60 kg (132 lb) to 90
kg (198 lb) for optimal system performance
Operating time
Approx. 6 hours of continuous use,
depending on activity type and level
Angle of flexion
Max. 115°
Operating temperature
–10°C to +40°C
Operating environment
0% to 100% RH (non-condensing)
Rating
42 V
Charge time
Max. 4 hours
Weight
4.7 kg, motorized module
Expected lifetime
5 years (3,000,000 steps)
18 A (max.)
APM
Operating temperature
–10°C to +40°C
Operating environment
0% to 100% RH (non-condensing)
Charge time
Max. 2.5 hours
Rating
4.2 V
Dimensions
76 x 69 x 18 mm (L x H x W)
Weight
175 mA (typ.)
90 g
Battery charger
20
Operating temperature
0°C to +40°C
Operating environment
30% to 95% RH (non-condensing)
Line supply
100-240 V~, 50-60 Hz, 165 VA
Dimensions
348 x 87 x 193 mm (D x H x W)
Weight
4.26 kg
5.4 TRANSPORT AND STORAGE CONDITIONS
Temperature: 0°C to +45°C
Humidity: 10% to 90% RH (non-condensing)
Handle with care.
Do not store or transport in harsh or marine environments.
6
WARRANTY
For warranty information, see the POWER KNEE™ Warranty Card.
7 PRODUCT CERTIFICATION INFORMATION
The POWER KNEE™ system has been tested by an independent, accredited laboratory and
found to comply with the IEC 60601-1 standard (Medical electrical equipment, general
requirements for safety) and its collateral standard IEC 60601-1-2 (Electromagnetic
compatibility, requirements and tests) and national deviations, as well as the MDD 93/42/EEC
European directive and ISO 10328 standard. The Össur hf. company fulfills the requirements
of ISO 13485. The POWER KNEE™ system carries the CE and/or CSA marks accordingly.
The POWER KNEE™ battery charger also meets IEC type B leakage current requirements (
).
21
Ossur Head Office
Ossur Europe
Ossur UK
Grjothals 5
110 Reykjavik, Iceland
Tel: + 354 515 1300
Fax: +354 515 1366
mail@ossur.com
Ekkersrijt 4108-4114
P.O. Box 120
5690 AC Son en Breugel
The Netherlands
Tel: 00800 3539 3668
Tel: +31 499 462840
Fax: +31 499 462841
saleseurope@ossur.com
Building 3000
Manchester Business Park
Aviator Way
Manchester M22 5TG
Tel: +44 (0)8450 065 065
Fax: +44 (0)161 490 8501
ossuruk@ossur.com
Ossur Americas
27412 Aliso Viejo Parkway
Aliso Viejo, CA 92656, USA
Tel: +1 800 233 6263
Tel: +1 949 362 3883
Fax: +1 949 362 3888
ossurusa@ossur.com
Ossur Canada
12111 Jacobson Way
Richmond, BC
V6W 1L5, Canada
Tel: +1 604 241 8152
Fax: +1 604 241 8153
www.ossur.com
Ossur Asia
Ossur Europe
Kundenservice Deutschland
Römerfeldstraße 2
50259 Pulheim, Germany
Tel: +49 (0) 2238 30 58 50
Fax: +49 (0) 2238 30 58 01
info-deutschland@ossur.com
Ossur Nordic
P.O. Box 67
751 03 Uppsala, Sweden
Tel: +46 1818 2200
Fax: +46 1818 2218
info@ossur.com
Suite 1908
Caohejing New Office Tower
Cao Bao Lu 509
P.B. 200233
Shanghai, China
Tel: +86 21 5426 6048
Fax: +89 21 5426 6049
asia@ossur.com
Ossur Asia Pacific
2 Redbank Road
Northmead NSW 2152
Australia
Tel: +61 2 9630 9206
Fax: +61 2 9630 -9268
info-asiapacific@ossur.com
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