OSSUB RHEO KNEE User manual

Instructions for Use / PatientEN

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Össurhf,Grjóthalsi 5, 110 Re ykjavík,Iceland2011
RHEOKNEE
RechargeableLi-IonBattery Operated
Rating:24V
1.0A(max.)
123456
0086
FCCID: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................................................................................
Summary of symbols on the RHEO KNEE®.......................................
Indications for use................................................................................
Contraindications for use.....................................................................
RHEO KNEE overview...........................................................................
Technical specifications........................................................................
Calibrating the RHEO KNEE.................................................................
Turning the RHEO KNEE ON and OFF................................................
3
4
5
6
6
6
7
8
8


ON OFF
Talux®Elation® Vari-Flex®
Ceterus®
B
D
C
A
Re-Flex Rotate™with EVO™
E
Flex-Foot Talux®
Elation®
Re-Flex Rotate™with EVO™Vari-Flex with EVO
®TM
3 H = Full
90 min = 90%
C
= 90-100%
= 0-90%
= FULL


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.
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.
Prosthetists should make sure their clients are aware of, and understand, the safety precautions.
• 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 will NOT provide stance support. The knee becomes a swing
only, single axis joint. In this case the user has to actively secure the knee and he or she should be
provided with the training to do so.
• It is highly recommended that the user walks with the power off prior to setting swing and stance
controls, but always use caution when walking with the power off.
• The RHEO KNEE stance control settings can be customized to maximize security or terrain recognition.
However, for maximum safety use a handrail when descending stairs and ramps.
• Improper handling or adjustment of the RHEO KNEE may cause the stance control to malfunction,
which can increase the risk of falls.
• Make sure that the user is able to recognize the auditory and/or vibratory signal for power loss.
• 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. 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 (for example electrical transformers, high
power radio/TV transmitters).
• 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. The battery should only be replaced by an
authorized service technician.
• 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.
CAUTION: Federal law requires this device to be sold by a prosthetist and by the order of a physician. The
healthcare practitioner must provide each client with training for appropriate use and proper application of the
RHEO KNEE.


SUMMARY OF SYMBOLS ON THE RHEO KNEE®
Attention - See instructions for use
On / Off
Type B Applied Part (IEC-)
CE label with Notified Body indentification 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.


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: kg (lbs).
• Distance from knee center to floor should be greater than or equal to cm (/’’).
CONTRAINDICATIONS FOR USE
Do not:
• Immerse in water or any other fluids.
• Use in dirty environments.
• Expose to extreme heat and /or cold.
RHEO KNEE®OVERVIEW
The RHEO KNEE®is the world’s first microprocessor knee system to use the power of artificial intelligence and
is the most adaptable solution of its kind; it adapts automatically to individual walking styles and different
environments, continuously learning and improving its responses over time.
The RHEO KNEE can be fitted to a much wider range of prosthetic feet than any other microprocessor knee on
the market because of its low build height (length).
RECOMMENDED FOOT SELECTION FIGURE A
Re-Flex Rotate with EVO
Flex-Foot Talux
Vari-Flex with EVO
Elation
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  times per second (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 light-weight 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.
SUPERIOR FUNCTION WITH OSSUR FOOT PRODUCTS
The RHEO KNEE has proven compatibility with Össur feet and shock systems for optimal knee function.
For best results use the RHEO KNEE with Reflex Rotate with Evo or Variflex with Evo.
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  of the FCC Rules. Operation is subject to the following two conditions: ()
this device may not cause harmful interference, and () 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)
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.
WARNING: DO NOT 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.
• DO NOT use solvents stronger than isopropyl alcohol.
• DO NOT use compressed air to clean the knee, as it can cause the knee to malfunction and deteriorate
prematurely.


CHARGING THE RHEO KNEE®
Before fitting the RHEO KNEE, charge the unit for  hours to ensure full charge.
CAUTION: Take the prosthesis off prior to charging.
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 CAPACITY
Rechargeable Lithium Ion Battery (mAh): Fully charged battery is sufficient for - hours of continuous
use, depending on activity.
BATTERY WARNINGS FIGURE C
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).
HOW TO CHARGE THE RHEO KNEE
Insert the charger cable into the charging port on the user interface panel.
It will take approximately . hours to charge the RHEO KNEE battery to %, and  hours to fully charge it
(%).
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
TURNING THE RHEO KNEE®ON AND OFF
HOW TO TURN THE RHEO KNEE ON
To turn the RHEO KNEE on press the ON/OFF button (Figure D). 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 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.


ELECTROMAGNETIC COMPATIBILITY PRECAUTIONS
SAFETY PRECAUTIONS
Because of electromagnetic compatibility (EMC) special precautions need to be taken with the RHEO KNEE:
• The RHEO KNEE should not be used adjacent to or stacked with other equipment. In case adjacent or
stacked use is necessary, the RHEO KNEE should be checked to make sure it operates normally.
• The RHEO KNEE can be susceptible to electromagnetic interference from portable and mobile RF
communications devices such as mobile (cellular) phones.
• The RHEO KNEE can be susceptible to interference from other equipment, even if the equipment
complies with CISPR EMISSION requirements.
GUIDANCE AND MANUFACTURER’S DECLARATION  ELECTROMAGNETIC EMISSIONS
The RHEO KNEE is intended for use in the electromagnetic environment specified below.
The customer or user of RHEO KNEE should assure that it is used in such an environment
Emissions Test Compliance Electromagnetic Environment - Guidance
RHEO KNEE 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 RHEO KNEE 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 
Class B
Class A
Complies
RF Emissions
CISPR 
RF Emissions
CISPR 
Harmonics Emissions
IEC --
Voltage
Fluctuations/Flicker
Emissions
IEC --


The RHEO KNEE is intended for use in the electromagnetic environment specified below.
The customer or user of RHEO KNEE should assure that it is used in such an environment.
Immunity Test IEC 
Test Level Compliance Level Electromagnetic Environment Guidance
+/-  kV contact
+/-  kV air
+/- kV for input/output
lines
+/-kV for power supply
lines
 A/m
 V(rms)  kHz to 
MHz
 V/m  MHz to
.GHz
<% UT (>% dip in
UT) for . cycle %
UT(% dip in UT) for 
cycles % UT (% dip
in UT) for cycles <%
UT (>% dip in UT) for
 sec.
+/-  kV line to line
+/-  kV line to earth
+/-  kV contact
+/-  kV air
+/- kV for input/output
lines
+/-kV for power supply
lines
 A/m
 V(rms)
 V/m
<% UT (>% dip in UT)
for . cycle % UT (%
dip in UT) for  cycles
%UT (% dip in UT)
for cycles <% UT
(>% dip in UT) for  sec.
+/-  kV line to line
+/-  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 %.
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 --
Electrical fast transient/burst
IEC --
Power frequency (/Hz)
magnetic field IEC --
Conducted RF IEC --
Radiated RF IEC --
Notes:
. UT is the a.c. mains voltage prior to application of the test level.
. Bluetooth RF Receptor / Transmitter Information:
• Frequency band of reception and transmission: , to ,MHz
• Modulation type: GFSK modulator (Bluetooth basic rate (BR))
• Effective radiated power:  dBm maximum (Power Level II)
Voltage dips, Short interruptions
and voltage variations on power
supply lines IEC --
Surge IEC --
GUIDANCE AND MANUFACTURER’S DECLARATION  ELECTROMAGNETIC IMMUNITY

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