VQ OrthoCare BIONICARE KNEE SYSTEM User manual

Operating Manual
(Manual de Instructiones / Manuel D’utilisation)
BioniCare®Knee System
(Sistema Para Rodilla BioniCare®/ Système Pour Genou BioniCare®)

VQ OrthoCare is not liable for misuse or misunderstanding of the BioniCare
product or operating manual. In the US, please call VQ OrthoCare’s Patient
Care Department at 800.444.1456 if any additional assistance is required
regarding this product and its operating instructions. Outside the US, please
contact your BioniCare System provider or your healthcare practitioner.
Operating Manual: BioniCare Knee System for the treatment of osteoarthritis
of the knee
US 5,273,033; CA 2,102,759; DE 69328429.3;
EP/IT 0652028; EP/GB 0652028; EP/FR 0652028;
EP/NL 0652028; EP/CH 0652028; EP/LI 0652028;
Other Patents Pending / Otras Patentes Pendientes / Autres Brevets en Instance
VQ OrthoCare no se hará responsable de ningún uso incorrecto o mala
interpretación del producto BioniCare o su manual de instrucciones. Para
obtener ayuda adicional sobre este producto y sus instrucciones de uso,
en los EE. UU. puede llamar al departamento de Atención al Paciente de
VQ OrthoCare al 800.444.1456. Fuera de los EE. UU., comuníquese con un
distribuidor del sistema BioniCare o con su profesional médico.
Manual de Instrucciones: Sistema para rodilla BioniCare para el tratamiento
de la osteoartritis de rodilla
VQ OrthoCare n’est en aucun cas responsable de la mauvaise utilisation
du produit BioniCare ou de tout malentendu concernant le contenu du
manuel d’utilisation. Si vous avez besoin de plus amples renseignements
concernant ce produit ou son utilisation et que vous résidez aux États-
Unis, veuillez appeler le Patient Care Department de VQ OrthoCare
au +1.949.261.3000. Si vous résidez en-dehors des États-Unis, veuillez
appeler le fournisseur de votre système BioniCare ou votre professionnel
de la santé.
Manuel d’utilisation: Système pour genou BioniCare pour le traitement de
l’arthrose du genou
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ESPAÑOL
FRANÇAIS

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Table of Contents
Prescribing Information.................................................................. 2
Introducing the BioniCare Knee System................................... 3
System Components ...................................................................... 4
General Operating Instructions ................................................... 4
Preparation and Treatment........................................................... 4
BioniCare Generator Features & Functions ............................. 7
Basic Use Screens .......................................................................... 8
Frequently Asked Questions........................................................ 10
Troubleshooting............................................................................... 11
Care and Cleaning .......................................................................... 12
Basic Specifications........................................................................ 15
EMC Compliance Table.................................................................. 16
U.S. and International Safety Standards.................................... 19
One Year Limited Warranty ........................................................... 20
Manual de Español ......................................................................... 22
Manuel de Français ........................................................................ 43
Notes .................................................................................................. 64

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BioniCare®Knee System
Prescribing Information
Caution
Federal law restricts this device to sale by, or on the order of, a practitioner
licensed by the law of the State in which he/she practices to use or order the
use of this device.
Indication
The BioniCare Knee System is indicated “for use as an adjunctive therapy in
reducing the level of pain and symptoms associated with osteoarthritis of the
knee and for overall improvement of the knee as assessed by the physician’s
global evaluation (clinical studies).”
Contraindications
• Do not use the BioniCare Knee System for any electrode placement that
applies current to the carotid sinus (neck) region.
• Do not use the BioniCare Knee System for any electrode placement that
causes current to flow transcerebrally (through the head).
• Do not use the BioniCare Knee System whenever pain syndromes are
undiagnosed, until etiology is established.
Warnings
• The BioniCare Knee System must be used only as prescribed and applied
only to the knee.
• Patients with demand type cardiac pacemakers should consult with their
physician prior to use of this system.
• The safety of the BioniCare Knee System for use during pregnancy has
not been established.
• The BioniCare Knee System is not eective for pain of central origin
(including headache).
• Use only under the continued supervision of a physician.
• Keep out of reach of children.
• Electronic monitoring equipment (such as ECG monitors and ECG alarms)
may not operate properly when the BioniCare Knee System is in use.
Precautions
• Isolated cases of skin irritation may occur at the site of electrode
placement following long-term application.
Adverse Reactions
• Skin irritation and electrode burns are potential adverse reactions.
Patients with skin irritation / reactions should be monitored.

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Introducing the BioniCare Knee System
BioniCare
Generator
BioniCare
Wrap
The BioniCare Knee System is prescribed by
physicians and other medical professionals
to treat osteoarthritis of the knee. It is a non-
drug, noninvasive therapy delivering a unique
electrical impulse that mimics the impulse
created naturally within a healthy knee.
The BioniCare Generator (BIO 2000) sends
this low voltage impulse to the knee joint
via electrodes that are held in place by the
BioniCare Wrap.
People diagnosed with osteoarthritis of the knee who regularly use
the BioniCare Knee System experience significant reduction of pain
and improvement in overall function, and may avoid costly, riskier
treatments over the long term. For more information, visit our web
site at www.bionicare.com.
Select Button ( )
Touch Screen
Display
Navigation Buttons Lead-Wire Jack
Lead-Wire Jack
Battery
Compartment
Serial Number
Label
Front View Back View
Top View

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BioniCare®Knee System
General Operating Instructions
This section describes the operation of the BioniCare Knee System for the
treatment of osteoarthritis of the knee. Each patient should read and become
completely familiar with the written operating instructions. Special attention
should be given to the sections on “Contraindications” and “Cautions”.
Charging the Battery for the BioniCare Generator:
The BioniCare Generator is powered by a single rechargeable Lithium Ion
battery. The battery charger can be used at 110 or 220 volts and fully charges
the battery in four hours. Use only the charger supplied by VQ OrthoCare as
improper charging can cause heat damage or even high pressure rupture.
Do not use any battery that shows any signs of corrosion, leaking or other
damage. Replace corroded, leaking or damaged batteries.
Preparation:
Prior to applying electrodes to the skin, the skin must be washed with soap and
water and completely dried. Electrodes are held in place by the BioniCare Wrap.
To prepare your brace or BioniCare Wrap for application and use, please refer
to the application instructions that were supplied with your BioniCare Knee
System. You may request a copy of the application instructions by contacting
our Patient Services Center toll-free at 800.444.1456 or by visiting our website
at www.bionicare.com.
Preparation and Treatment
System Components
(1) BioniCare Wrap
(1) Knee Wrap*
(1) Thigh Liner*
(1) Knee Electrode
(1) Thigh Electrode
(1) BioniCare Generator (BIO 2000)
(1) Lead Wire
(1) Battery Charger
(1) Bluetooth Dongle (optional)
(2) Rechargeable Batteries
Lead WireBioniCare Wrap Knee Electrode Thigh Electrode
(2) Rechargeable Batteries
BioniCare Wrap
Knee Electrode
BioniCare
Generator
Bluetooth
Dongle*
Rechargeable
Battery
Knee Wrap*
Thigh Liner*
Catalyst-Propel OA
OActive 2
OActive 2
Catalyst-Propel OA
*optional

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BioniCare Night-Wrap Application Guide:
STEP 1. Install electrodes on the BioniCare Wrap. Lay the BioniCare Wrap on
the leg with the longer strap closer to the waist, and so that the graphics of
the wrap are visible. Ensure that the kneecap (patella) is centered beneath the
patella marking.
Apply the thigh electrode by peeling o the white paper backing and adhering the
electrode to the wrap within the markings. The wire should extend up toward the
waist. The white side of the electrode should be against the wrap and black side
goes on the skin.
Apply knee electrode by peeling o the white paper backing (1a) and adher-
ing the electrode to the wrap within the markings as pictured (1b). The wire
should extend downward. The white side of the electrode should be against
the wrap and black side goes on the skin.
STEP 2. Apply the BioniCare Wrap. Remove the clear backing from both
electrodes (2a). Position the wrap so that the electrodes are facing leg (keep
long strap closer to the waist).
Center the small round area of the electrode over the patella, and gently press
the knee electrode to the knee while keeping the thigh portion of the wrap
away from the leg (2b). While grasping the top edge of the wrap, gently tension
it, and then adhere the thigh electrode to the skin.
Wrap the straps around the leg and secure hook tabs to the wrap (2c, 2d).
Straps may be trimmed as needed. Best performance is achieved when the
lower strap crosses over the patella, wrapping the patella in two layers.
2a
2b
SIDE VIEW
KNEE
CALF 2c
WIRE
1b
1a
2d
WIRE
STEP 3. Connecting the Device:
The lead wire connects the BioniCare Generator to the
knee and thigh electrodes. The single end of the Wire
inserts into the female connector on the generator and
the other end divides into two ends with color-coded
tips. Figure 1 Figure 2
WHITE SIDE
BLACK
SIDE
BLACK SIDE

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BioniCare®Knee System
Preparation and Treatment (cont.)
STEP 4. Starting Your Treatment
1. Check that the electrodes are in place and all connections and adjust-
ments are correct.
2. Turn the BioniCare Generator on by pressing the Select/Power button
until BioniCare appears on the screen. Unlock the device by pressing the
lock on the screen or the button. The screen will then advance to the
main treatment menu.
3. Press the play button.
4. Increase the stimulation by pressing the Increase Button on the touch
screen or the corresponding manual button. Increase until you feel a
tingling sensation in the thigh or knee.
5. Press the Decrease Button on the touch screen or the corresponding
manual button a few times to reduce the stimulation just enough so you
no longer feel the tingling sensation. You have now begun your treatment.
play button.
Increase the stimulation by pressing the Increase Button on the touch
screen or the corresponding manual button. Increase until you feel a
Press the Decrease Button on the touch screen or the corresponding
manual button a few times to reduce the stimulation just enough so you
Note: The BioniCare Generator must be set at 2.0V or greater. If the voltage is set
below 2.0 V, the device will begin to beep after 5 minutes and will turn o after 10
minutes.
Note: Optimal Treatment time is 6 - 10 hours per day (minimum) or as much as possible.
1. Connect the two color coded lead wire ends to the electrode wires. Make
sure the BioniCare Generator is turned o. Attach red (knee) electrode to the
red lead wire tip and the black (thigh) electrode to the black lead wire tip.
2. Now connect the single lead wire end to the BioniCare Generator as seen
in figures 1 and 2.
BioniCare System Removal Steps:
STEP 1. Unhook knee wrap from straps and carefully peel from knee.
Place clear plastic backing onto knee electrode for protection when not in use.
STEP 2. Remove brace. Place clear plastic backing onto thigh electrode.
Note: There is no need to remove the electrodes from the BioniCare wrap upon
removal. Leave the electrodes in place and cover the electrodes with the clear backing
to keep the electrodes clean and to prevent them from prematurely drying.

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The BioniCare Generator is a small, portable and battery-powered FDA
Class II medical device that produces a unique, electrical signal to treat
osteoarthritis of the knee.
Manual Buttons
There are 3 manual push buttons that control functions on the device.
Select ( ) Button functions:
• Turns the power on or o (4 second hold to turn o)
• Enters the selected function or value from the highlighted icon
in the touch screen
• Unlocks the device
Navigation (outer buttons) functions:
• Allow scrolling through the menus and icons (icons are highlighted
when they’re active)
• Control stimulation level
Touch Screen Display
The Touch Screen Display allows the user to control the device and provides
information regarding its operation and status. Virtually all of the functions
of the device can be viewed and controlled via a finger touch on the touch
screen.
Main functions:
• Start treatment
• Set/view stimulation (measured in volts)
• View overall hours of treatment
• Check battery charge
• Unlock device
• Control settings of device parameters
BioniCare Generator Features & Functions

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BioniCare®Knee System
Basic Use Screens
1. Main Display Screen
2. Voltage Setting Screen
3. Treatment Running Screen
4. Locked Mode Screen
1. Back Button (press to return to previous screen)
2. Menu Button (press to advance to settings menu)
3. Battery Level (press for full screen reading)
4. Clock
5. Start Button (press to set voltage and begin treatment)
6. Usage time
Increase Button (press to increase voltage)
Voltage (press to adjust stimulation level)
Unlock button (press to unlock)
Usage time (press for full screen reading)
Running indicator
Decrease Button (press to decrease voltage)
Quick Tip: Navigation buttons may also be used to adjust voltage
Quick Tip: Select button may also be used to unlock
Voltage from 00.0 to 12.0
1 2 3
45
6

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5. Settings Menu Screen
Display Settings
Language, Screen Orientation, Color and Brightness
General Settings
Progress Survey Questions, Clock Format,
Time Zone, Audible and Idle Mode Settings
Time Settings
Calendar Settings Technician Settings
Bluetooth Connection
Understanding Special Display Messages: Special messages may appear
on the display screen during use to report a low battery condition or other
operational conditions that require attention.
Low Battery: When the device determines the battery is approaching the end
of its usable charge, the device will continue to operate but the battery icon
on the main display screen will flash and audible beep will sound. When this
occurs, recharge the battery or replace it with a freshly charged battery.
Open (circuit): An “Open” circuit message will be displayed and an audible
beep will sound if 1) the lead wire is disconnected from the generator (“Open”
does not flash in this case) or 2) an electrode either loses skin contact or the
wire is disconnected (“Open” will flash in these cases).
Advanced Device Functions: The BioniCare Generator has data recording
and Bluetooth communication capabilities to allow it to capture patient data
input and transmit it automatically to the BioniCare website. The patient
can then access the website to see their progress. For information and
instructions for the website, go to www.bionicare.com.
Description of data collection and transmitting functions:
• Record patient progress via simple survey questions on the
generator display
• Upload of patient progress data to BioniCare website to track
performance and outcome measurements
NOTE: This display can only be accessed when amplitude is 0 Volts

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BioniCare®Knee System
BIONICARE GENERATOR CAUTIONS
• Do not connect the BioniCare Generator to any electrical outlet.
• Remove the battery from the BioniCare Generator during long-term
storage to prevent battery leakage. Failure to do so may damage the
BioniCare Generator.
• Replace batteries immersed in water or liquid. Failure to do so may
damage the BioniCare Generator.
• Do not store batteries with their terminals touching. Batteries may be
damaged or their charge drained.
• When using rechargeable batteries, carefully read and follow all
instructions provided with the batteries and the battery charger.
• Dispose of batteries according to current federal, state and local
regulations.
!
Basic Use Screens (cont.)
Frequently Asked Questions
Q. How often do I need to recharge the battery?
A. Since your BioniCare system comes with two batteries, you have the ability
to charge one battery while the other is in use. Use a fully charged battery
for every treatment. Do not use any other battery with the BioniCare system.
Q. What are the side eects, if any?
A. There are no serious side eects associated with the BioniCare system.
Some patients develop a mild rash under the Electrodes or Wrap.
Q. How do I get new supplies of electrodes and batteries?
A. In the US, just call our Patient Services Center toll-free at 800.444.1456,
Mon. - Fri., 7 a.m. - 5 p.m. (PST) or log online, www.bionicare.com/supplies.
Outside the US, please contact your BioniCare provider or your healthcare
practitioner.
Q. How frequently should I reorder electrodes?
A. You should reorder your electrodes before you need them so you can
continue your regular treatment. Electrodes should be replaced after 10
to 14 days of use at 8 hours per day. This time may vary. Routine visual
inspection of electrode condition is recommended, and changing
electrodes in a timely manner ensures optimum performance.

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Q. Can the knee wrap and liners be washed and dried?
A. Yes. You can hand wash and air dry the knee wrap. Make sure to remove
electrodes before washing. Use only mild soap, such as Ivory®or Woolite®;
never use bleach, detergent or fabric softener. Air dry. Never run any of
the System’s component through the washer or dryer. Never place your
Wire, BioniCare Generator, battery or battery charger in water; these items
can be wiped clean with a damp cloth or cotton swab. Electrodes may be
rehydrated with water by dabbing them with a wet, lint-free cloth.
Q. I can’t feel the tingle during setup, what do I do?
A. It’s OK and quite normal to not feel the tingle. If this occurs, set the
voltage to 8.4 volts. This will provide your BioniCare treatment while
maintaining battery life. Your voltage level to produce a tingle may also
vary daily. Ramp up the voltage until you feel it, and then back it down a
few tenths of a volt until you don’t feel it. Run it at this level. You should
not feel a constant tingle when treating.
Troubleshooting
1. Check all connections to the electrodes and BioniCare Generator.
2. Be sure the correct side (clear backing side) of the electrodes is facing the skin.
3. Check the Wires to be sure there are no frayed ends and that they are
secured to the electrodes. If your Wire is frayed, in the US, contact Patient
Services for a replacement. Outside the US, please contact the provider
that delivered your BioniCare System.
4. Consider the last time you replaced the electrodes; if they no longer
adhere to your skin, it is probably time to order new ones. If after you’ve
checked these solutions the BioniCare Generator still reads OPEN, phone
Patient Services. Outside the US, please contact your BioniCare provider
or your healthcare practitioner.
Problem: Your skin has a rash or irritation.
To prevent escalation of the rash, immediately stop using the device until the
rash or irritation clears up. If possible, determine the source of the problem.
The electrode is the most likely cause in nearly all cases. Some patients
may be allergic to the Wrap or brace liner fabric. In all cases, stop using the
device until the rash is gone. Once your rash has completely healed, resume
treatment. If the rash re-appears, in the US, call our Patient Services Center
toll-free at 800.444.1456. Outside the US, please contact your BioniCare
provider or your healthcare practitioner. Warning: Continued use of the
device with a rash may worsen the condition to the point of causing blisters,
open sores or infection. Notify your physician if your rash has worsened even
after you’ve stopped using the device.

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BioniCare®Knee System
Troubleshooting (cont.)
Problem: Battery will not hold a charge.
Your BioniCare Generator may display a “Low Battery” indication. Keep track of
how long the battery lasts during one treatment session. If the battery lasts eight
hours or more, the battery is functioning normally. Remember to charge both
batteries initially for at least 4 hours; be sure the battery charger is not plugged
into an outlet controlled by a light switch. In order to hold their maximum charge,
the batteries must be cycled (fully charged and fully drained) 4 to 5 times. If you’re
travelling overseas be sure to get a converter adapter for the charger.
Problem: Display is blank and the BioniCare Generator shuts o.
If your Generator shuts o, you may have accidentally turned it o or unplugged
the Wire. If you can turn on the Generator normally then this is most likely the
problem. If the Generator does not turn back on, it might mean the battery has
completely discharged and has turned o normally. Plug in a charged battery
and check the battery percentage. A fully charged battery should say “100%”.
One last thing; be sure to hold down the On/O button for about one second; if
the button is not pressed long enough the Generator will not turn on. The best
way to know you’re doing it right is to wait for BioniCare logo to display, then
let go of the On/O button.
BioniCare Generator
The case of the BioniCare Generator may be cleaned with a cloth and cotton
swab. The BioniCare Generator should be turned “OFF” and not connected to the
Wire when cleaning. Do not use liquids for cleaning; the BioniCare Generator is
not waterproof. The BioniCare Generator case must not be opened by removing
the screws, because there are no operator serviceable components inside.
Always store the BioniCare Generator in a clean, dry area between 0° and 140°F.
• Do not use the BioniCare Generator with a battery other than the
original battery supplied or an exact replacement battery.
• Do not use any Wire or cord if the insulation is damaged or if the
conductive strands are exposed.
• Do not immerse the BioniCare Generator, batteries, battery charger
or Wires in water or any other liquid.
• Do not wear and use the Device while bathing, swimming or any
other activity that would get the Device wet.
• Do not use the BioniCare battery charger with extension cords or
adaptor plugs.
Care and Cleaning

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• Do not use the BioniCare Generator or its battery charger in the presence
of flammable liquids.
• Do not use the BioniCare Generator or the battery charger in the
presence of explosive atmospheres.
• Do not leave the battery charger plugged into an electrical outlet
between charges.
• The BioniCare Generator has no field serviceable components. If you
suspect a malfunction, discontinue use and in the US, call VQ OrthoCare
at 800.444.1456 toll free. Outside the US, please contact your BioniCare
provider or your healthcare practitioner.
BioniCare Wrap
To clean the above soft goods, the electrodes should first be removed and
the brace liner/wrap should be removed from the brace. It should be hand
washed in cold water with mild detergent. Rinse thoroughly and air-dry
(do not machine dry). Never machine wash the BioniCare Wrap. Never use
bleach, fabric softener, or harsh detergents. The other brace liners and straps
should be washed in the same manner.
Electrodes
• Factory manufactured electrodes have been designed and authorized
specifically for use with this product and must not be manipulated or
altered in any way.
• Do not use alcohol to clean skin surface.
• Apply electrodes to dry, clean, unbroken skin surfaces only, checking all
edges for proper adhesion. Prior to electrode application, the skin should
be washed with soap and water and completely dried.
• Do not apply skin lotion prior to application of electrodes.
• Electrodes should always be placed at least one inch apart.
• Do not trim electrodes, as cut edges may aect the even distribution
of stimulation.
Electrodes
• Remove electrodes before showering.
• Place clear plastic backing onto knee and thigh electrode for protection
when not in use.
• If you experience symptoms of skin irritation while using the BioniCare
Knee System, discontinue use immediately and in the US, contact
VQ OrthoCare’s Patient Care department at 800.444.1456, or consult
your healthcare practitioner. Outside the US, please contact your
BioniCare provider or your healthcare practitioner.

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BioniCare®Knee System
CAUTION
Electrodes should be discarded and replaced if damaged or when proper
adhesive tack can no longer be obtained, the gel has separated, or you
sense a change in stimulation intensity. If in doubt about the integrity or
proper function of any electrode, replace it before proceeding with treatment.
If using pain medication and/or other pain management devices, exercise
caution when increasing amplitude on the BioniCare device.
Service
Do not return the BioniCare Knee Device to your physician’s oce. This
BioniCare Generator contains no user serviceable parts and must be returned
to VQ OrthoCare or its representatives for service, repair or calibration at its
factory.
Care and Cleaning (cont.)

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Specification* BioniCare Knee System
Frequency 100Hz ± 5 Hz, fixed digital
Waveform Monophasic spike-shaped pulse analog generated
Voltage Output Range 0-15 volts peak - digital
Voltage Pulse Width 1.8 ms @ 10% pt. of peak
0.64 ms @ 50% pt. of peak
Current Pulse Range 0-30 mA peak @ 500 ohms resistive load
Current Pulse Width 1.8 ms @ 10% pt. of peak @ 500 ohms resistive load
0.64 ms @ 50% pt. of peak @ 500 ohms resistive load
Maximum Output Charge 25 µC into a load of 500 ohms
Display LCD
Power Source 3.7V Li-Ion battery
Standard: ANSI/AAMI NS4-1985 Compliant
Dimensions 3.56” (90.5mm) X 2.13” (54.0mm) X 0.59” (15.0mm)
Weight 0.152lb or 2.45oz or 69g (With battery)
0.110lb or 1.75oz or 50g (Without battery)
Electrical Protection Rating Type BF Equipment, Battery Operated
*Electrical specifications are +/- 10% into a 500 ohm load unless otherwise noted.
ms = milliseconds LCD = liquid crystal display
µC = microcoulombs mA = milliamperes
Output Waveform
The signal is a spiked shape, monophasic, asymmetrical, DC output.
Basic Specifications
Width at 10% Peak = 1.8msec
Width at 50% Peak = 0.64msec
Output
Output Waveform
Normalized Symbols
This device is a FDA Class II device with its own internal electrical power,
with type BF applied sections. IMPORTANT: The information in this manual
must be strictly observed. The ON/OFF switch is a multi-function key.
Specs Operating Conditions Storage and Transport
Temperature: 5° C - 40° C -25°C - +70°C
Relative Humidity: 15% - 93% 30 - 93%
Atmospheric Pressure: 700 to 1060 hPa (0.69 to 1.05 atm) 700 to 1060 hPa (0.69 to 1.05 atm)
The BioniCare is rated IP22 in accordance with IEC60529. This rating means that the device
is protected against ingress of foreign objects larger than 12.5mm and against ingress of
water with harmful aects when exposed to dripping at 15 degree tilt.

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BioniCare®Knee System
Medical electrical equipment needs special precautions regarding EMC and needs to
be installed and put into service according to the EMC information provided below.
Portable and mobile RF communications equipment can aect medical electrical
equipment.
Use of lead wires and other accessories other than those supplied by VQ OrthoCare
may result in increased emissions or decreased immunity of the BioniCare Knee
System.
Guidance and manufacturer’s declaration - electromagnetic emissions
The BioniCare Knee System is intended for use in the electromagnetic environment specified
below. The customer or user of the BioniCare Knee System should assure that it is used in
such an environment.
Emissions test Compliance Electromagnetic Enviornment - Guidance
RF Emissions Group1
The BioniCare Knee System uses RF energy only for
its internal function. Therefore it RF emissions are
very low and are not likely to cause any interference
in nearby electronic equipment.
RF Emissions Class B
The BioniCare Knee System 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.
Harmonic emissions IEC
61000-3-2 Complies
Voltage fluctuations /
flicker emissions IEC
61000-3-3
Complies
Guidance and manufacturer’s declaration - electromagnetic immunity
The BioniCare Knee System is intended for use in the electromagnetic environment
specified below. The customer or user of the BioniCare Knee System should assure that it
is used in such an environment.
Immunity test IEC 60601
Test Level Compliance level
Electromagnetic
environment -
guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 6 kV contact
± 8 kV air
± 6 kV contact
± 8 kV air
Floors should be
wood, concrete or
ceramic tile. If floors
are covered with
synthetic material,
the relative humidity
should be at least
30%.
Electrical fast
transient / burst
IEC 61000-4-4
± 2 kV for power
supply lines
± 1 kV for input /
output lines
Not Applicable Not Applicable
EMC Compliance Table

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Guidance and manufacturer’s declaration - electromagnetic immunity
Immunity test IEC 60601
Test Level
Compliance level Electromagnetic
environment -
guidance
Surge
IEC 61000-4-5
± 1 kV line(s) to
line(s)
± 2 kV line(s) to
earth
Not Applicable Not Applicable
Voltage dips, short < 5 % UTNot Applicable Not Applicable
Interruptions and
voltage variations on
power supply input
lines
IEC 61000-4-11
(>95 % dip in UT)
for 0,5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
< 5 % UT
(>95 % dip in UT)
for 5 s
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m Not Applicable Not Applicable
NOTE: UTis the a.c. mains voltage prior to application of the test level.
Guidance and manufacturer’s declaration - electromagnetic immunity
The BioniCare Knee System is intended for use in the electromagnetic environment
specified below. The customer or the user of the BioniCare Knee System should assure
that it is used in such an environment.
Immunity test IEC 60601
Test Level
Compliance
level Electromagnetic environment - guidance
Portable and mobile RF communication
equipment should be used no closer to any
part of the BioniCare Knee System than
the recommended separation distance
calculated from the equation applicable to
the frequency of the transmitter.

18
ENGLISH
BioniCare®Knee System
Guidance and manufacturer’s declaration - electromagnetic immunity
Immunity test IEC 60601
Test Level
Compliance
level Electromagnetic environment - guidance
Conducted RF
IEC6100-4-6
3 Vrms
150KHz to
80MHz
3 Vrms
Recommended Separation Distance
d = 1.2 √P
Radiated RF
IEC 610004-3
Radiated RF
IEC 61000-4-3
(continued)
3 V/m
80MHz to
2.5GHz
3 V/m d = 1.2√P
80 MHz to 800MHz
d = 2.3√P
800 MHz to 2.5GHz
Where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter manufacturer
and d is the recommended separation
distance in meters (m).
Field strengths from fixed RF transmitters,
as determined by an electromagnetic Site
surveya, should be less than the compliance
level in each frequency range b.
Interference may occur in the vicinity of
the equipment marked with the following
symbol:
(IEC 60417 No. 417-IEC-5140: “Source of
non-ionizing radiation”)
Note: At 80MHz and 800 MHz, the higher frequency range applies.
Note: These guidelines may not apply in all situations. Electromagnetic propagation is
aected by absorption and reflection from structures, objects and people.
a. Field strengths from fixed transmitters such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV
broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the BioniCare Knee
System is used exceeds the applicable RF compliance level above, the BioniCare Knee
System should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as re-orienting or relocating the
BioniCare Knee System.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
EMC Compliance Table (cont.)
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