Ossur RHEO KNEE 3 User manual

EN | Instructions for Use

4
SAFETY PRECAUTIONS 6
INDICATIONS FOR USE 6
CONTRAINDICATIONS FOR USE 7
CHARGING THE RHEO KNEE  7
TURNING THE RHEO KNEE  ON AND OFF 7
EXTENSION LOCK 7
MAINTENANCE 7
TECHNICAL SPECIFICATIONS 8

Attention – See instructions for use
On / Off
Type B Applied Part (IEC-)
CE label with Notified Body
identification number
Non-ionizing radiation
Manufacturer
Year of manufacture
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.

4
Re-Flex Rotate™ Talux®Vari-Flex®


3 H = Full
90 min = 90%
12 1
2
11
10
5
4
7
8
3
6
9

= 0–90%
= 90–100%
= FULL

RECOMMENDED FOOT SELECTION

5


6
SAFETY PRECAUTIONS
Please follow the safety precautions as failure to do so can lead to
malfunction of the RHEO KNEE® and risk injury to the user.
. The RHEO KNEE  is designed and tested for everyday activities, but
not for sports and other high impact activities (e. g., running and
climbing). Doing activities causing high impact on the leg can injure
the user, can cause the RHEO KNEE  to break down or malfunction,
and will void the warranty.
. If the RHEO KNEE  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.
. For maximum safety use a handrail when descending stairs
and ramps.
. When malfunctions occur or the power reaches critical levels, auditory
and/or vibratory warnings alert the user. If warning signals are
detected, check if the knee can provide stance control. Engage the
extension lock and proceed to walk with caution.
. Avoid any impact to the socket, frame, adapter contact, or the
interface panel on the back of the RHEO KNEE . Damage to this
panel or any of its components may cause the product to
malfunction.
. 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.
. The RHEO KNEE  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.
. Because the RHEO KNEE  is battery operated, caution should be
taken about exposure to water and excessive mechanical shocks or
vibrations.
. Do not attempt any repairs (no matter how minor) on the
RHEO KNEE . This may damage the knee, cause malfunction or
failure, and will void the warranty.
. Never operate this product if it is not working properly, if it has been
dropped or damaged, or immersed in water. In such cases return the
product to your healthcare provider for examination and repair.
. 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.
. Follow local ordinances or regulations for proper disposal of device,
accessories and packaging. The battery should be disposed of in
accordance with local laws and regulations. It should not be
incinerated.
INDICATIONS FOR USE
• Activity level: Low, moderate and high
• Activity examples: Shopping, longer walks, golfing
• Weight limit:  kg (lbs)
• Distance from knee center to floor: ≥cm (⁄")

7
CONTRAINDICATIONS FOR USE
 :
• Immerse in water or any other fluids.
• Use in dirty environments.
• Expose to extreme heat and /or cold.
CHARGING THE RHEO KNEE 
How to charge the RHEO KNEE 
• Insert the charger cable into the charging port on the user interface
panel (Figure ).
• It will take approximately . hours to charge the RHEO KNEE 
battery to %, and  hours to fully charge it (%) (Figure ).
• RHEO KNEE  should be charged daily for optimal performance.
• It is not possible to overcharge the RHEO KNEE .
• The RHEO KNEE  can be charged regardless of whether it is turned
ON or OFF
Battery warnings (Figure )
When battery is low a repeating warning pulse will appear: A short sound
repeats every  seconds and orange light flashes on the interface panel.
At this point the RHEO KNEE  should be recharged. How much time is
left on the battery depends on activity (approximately  minutes of
walking on level ground or min of stair descent).
When battery is critically low, a buzzing, vibrating and a flashing red light
will signal an imminent shut down (after  seconds).
Battery capacity
Rechargeable Lithium Ion Battery (mAh): Fully charged battery is
sufficient for – hours of continuous use, depending on activity.
TURNING THE RHEO KNEE  ON AND OFF
How to turn the RHEO KNEE 3 on
To turn the RHEO KNEE  on press the ON/OFF button (Figure ). You
will hear a  beep confirmation.
When the RHEO KNEE  is on, you will see a pulsing green light on the
light indicator beside the ON/OFF button on the user interface panel.
How to turn the RHEO KNEE 3 off
To turn the RHEO KNEE  off press the ON/OFF button and hold it
down until you hear  short beeps and  long beep.
When the RHEO KNEE  is off, the light indicator on the user interface
panel will also turn off.
EXTENSION LOCK
See Figure 
MAINTENANCE
The unit should be sent to Össur for repairs or service. No other
company or individual is allowed to service or repair the unit in any way.
Before sending the RHEO KNEE  for repairs or service, make sure that
the operating instructions have been followed accurately.
:   disassemble the knee joint or attempt repairs as this
might create a hazard for the user and will automatically void warranty.
Cleaning
• Clean the knee with a damp cloth and mild soap or isopropyl alcohol.

8
•   use solvents stronger than isopropyl alcohol.
•   use compressed air to clean the knee, as it can cause the
knee to malfunction and deteriorate prematurely.
TECHNICAL SPECIFICATIONS
Safety standards and classification
The RHEO KNEE  is tested and certified to comply with the IEC/
EN-, standard of electrical safety of medical devices and IEC/
EN--, electromagnetic compatibility for medical electrical devices
and ISO . The company fulfills the requirements of ISO, MDD
//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.”
Environmental conditions
• Operating temperature: - °C to  °C (°F to °F)
• Operating humidity: % - % relative humidity (non-condensing)
• Shipping and storage temperature: - °C to  °C (°F to °F)
• Shipping and storage humidity: % - % relative humidity (non-
condensing)
Power supply information
• Power input: An external power supply for medical use.
• Input: – VAC
• Input frequency: – HZ
• Input current: .A
• Output voltage:  VDC
• Output current: . A
• Operating temperature: °C to  °C
• Operating humidity: % to % relative humidity (non-condensing)
• Manufacturer: UE Electronic
• Model No.: UEWCP-SPA

EN – Caution: Össur products and components are designed and tested to ISO. Compatibility and
compliance with this standard is achieved only when Össur products and components are used with other
recommended Össur or authorized components. 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.å slutte å bruke enheten og rådføre seg
med klinisk spesialist. Dette produktet er utformet og testet basert på at det brukes av én enkelt pasient.
Det er et engangsprodukt, og det skal ikke brukes av flere pasienter. Ta kontakt med legen din umiddelbart
dersom det oppstår problemer relatert til bruk av produktet.

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