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BioniCare® Knee System
18011 Mitchell South, Irvine, CA 92614
Call 949.261.3000 Fax 800.821.8012
www.vqorthocare.com
customerservice@vqorthocare.com
Operating Manual
Manual de Instrucciones
Manuel D’utilisation
© 2015 VisionQuest Industries, Inc.
VQO511703REVA
MANUFACTURED AT
1390 Decision St, Suite A
Vista, CA 92081, USA
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
BioniCare® Knee System
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
Notes; Notas; Remarques:
ENGLISH
ESPAÑOL
FRANÇAIS
NOTES; NOTAS; REMARQUES | 97
BioniCare® Knee System
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Table of Contents
How Much Relief ................................................................2
Prescribing Information .......................................................3
Introducing the BioniCare Knee System ...............................4
System Components ............................................................6
General Operating Instructions ............................................7
Preparation and Treatment ...................................................7
BioniCare Generator Features & Functions ..........................13
Basic Use Screens ................................................................14
Six Keys to Treatment Success ..............................................17
Frequently Asked Questions ................................................18
Troubleshooting ...................................................................21
Care and Cleaning ...............................................................23
Basic Specifications .............................................................25
EMC Compliance Table .......................................................27
U.S. and International Safety Standards ...............................29
One Year Limited Warranty ..................................................30
Manual de Español ..............................................................33
Manuel de Français .............................................................65
Notes, Notas, Remarques ....................................................97
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BioniCare® Knee System
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How much relief of my osteoarthritis will I
receive with the BioniCare Knee System? The answer, in large
part, will depend on......you.
You are one of tens of thousands of patients whose doctor has prescribed
the BioniCare Knee System to treat osteoarthritis of the knee. Some patients
benefit more than others from this non-drug, non-invasive treatment. What
are they doing to get better results? They understand that improvement in
their knee won’t happen overnight, since their osteoarthritis likely developed
over many years. To be successful, they commit to using their device for at
least 6-10 hours each day over many months. Your commitment to long-term
daily use is the key to your success. Like many users, you may begin to feel
an improvement within a few weeks. Clinical studies show that in the short
term, you may experience pain relief and improvement in knee function. With
continued use, researchers found that many users’ need for pain medications
decreased or ended entirely. Over the long term, a major four-year study
demonstrated that BioniCare-treated patients had significantly fewer total
knee replacements. Relief of pain, improved function, and decreased drugs
are common benefits. These are some of the many reasons to commit today
to faithfully follow your doctor’s prescription for daily treatments. For more
data from these medical studies and to read encouraging success stories
from actual BioniCare patients like you, please visit our web site at
www.BioniCare.com.
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BioniCare® Knee System
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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 effective 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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BioniCare® Knee System
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BioniCare Knee System shown with the OActive 2 Knee Brace
Introducing the BioniCare Knee System
BioniCare
Generator
BioniCare
Knee 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 OActive 2® or Catalyst-Propel™ OA braces, or
the BioniCare Night-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 treat-
ments over the long term. For more information, visit our web site at
www.BioniCare.com.
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BioniCare® Knee System
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Select Button ( )
Touch Screen Display
Navigation Buttons
Lead-Wire Jack
Lead-Wire Jack
Battery Compartment
Serial Number Label
Front View
Back View
Top View
6
BioniCare® Knee System
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System Components
System Components
(1) Knee Wrap (OActive 2 and Catalyst-Propel OA Systems)
(1) Thigh Liner (OActive 2 and Catalyst-Propel OA Systems)
(1) Night-Wrap
(1) Knee Electrode
(1) Thigh Electrode
(1) BioniCare Generator (BIO 2000)
(1) Lead Wire
(1) Battery Charger
(1) Bluetooth Dongle
(2) Rechargeable Batteries
Components of the BioniCare Knee System
BioniCare
Generator
BioniCare Knee System shown
with OActive 2 Brace
Lead Wire
Knee Wrap for
Catalyst-Propel OA
BioniCare
Night-Wrap
Knee Wrap
for OActive 2 Knee
Electrode
Thigh Electrode
Bluetooth
Dongle
Thigh Liner for
OActive 2
Thigh Liner for
Catalyst-Propel OA
Rechargeable
Battery
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BioniCare® Knee System
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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 liners
and knee wrap of the OActive 2 or Cataylst-Propel OA brace, or by the BioniCare
Night-Wrap. To prepare your brace or Night-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 instruc-
tions by contacting our Patient Services Center toll-free at 800.444.1456 or
by visiting our website at www.BioniCare.com.
BioniCare with OActive 2 Application:
STEP 1. Attach knee wrap to brace (1a).
With the pointed end of the condyle pocket
pointed towards the kneecap, pull the wrap
over the condyle cap (1b). Make sure the
condyle cup/pad is completely covered by
the wrap.
STEP 2. Replace thigh liner by removing
the standard OActive 2 liner from the brace
and replacing it with the one included in
the BioniCare kit.
NOTE: These steps may have been done
for you by a technician.
Preparation and Treatment
1a
1b
CONDYLE CUP
FRONT
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BioniCare® Knee System
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Apply thigh electrode to thigh liner. Peel
the white backing from the thigh electrode
(2a). Adhere electrode to the thigh liner,
centering it in the outlined area. Make sure
that the wire extends toward the top of the
liner. The white side of the electrode should
be against brace or liner and black side
goes against the skin.*
Peel clear plastic gel backing (2b). Keep
plastic backing for protection of electrode
when not in use.
Apply Brace to leg, as detailed in brace
application instructions.Leave knee wrap
unattached (see OActive 2 application
instructions).
STEP 3. Apply knee electrode. Peel clear
plastic backing from knee electrode. With
knee at 45°, adhere electrode to knee by
first placing center section over kneecap
with wire extending down as shown.
Center the round area in the middle of the
electrode over the kneecap (3). Then press
entire electrode firmly to skin. Peel white
backing off electrode. The white side of the
electrode should be against brace or liner
and black side goes against the skin.*
STEP 4. Apply knee wrap around the knee
and secure in front with velcro tab (4). Make
sure to route wire upward towards thigh.
2a
4
2b
3
Preparation and Treatment (cont.)
*For demonstration purposes, electrodes are shown here in a contrasting color.
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BioniCare® Knee System
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BioniCare with Catalyst•Propel OA Application:
1a
FRONT
STEP 1. Attach knee wrap to brace (1a).
Front side of the knee wrap has a tag on it.
With front of brace and knee wrap facing
toward you, place one loop of knee wrap
over the plastic condyle cup on the brace
as shown (1b).
Pull knee wrap around back of brace, then
around the outside of the other hinge. Secure
the remaining loop around the plastic condyle
cup. Wrap will be stretched across back of
knee brace (placing knee in brace will push
it forward)(1c).
NOTE: Tag side should be facing the front
of the brace.
STEP 2. Replace thigh liners with BioniCare
liner. Install BioniCare liner in the same
position as the original side-liners with the
thigh cuff covered as shown (2). The softer
protruding area on the liner should face
toward the skin.
STEP 3. Install thigh electrode. Remove
white backing from the thigh electrode.
Adhere electrode to the thigh liner, centering
as shown (3). Electrode wire should top of
the brace. The white side of the electrode
should be against brace or liner and black
side goes against the skin.*
STEP 4. Install knee electrode. Temporarily
place the brace on the leg backwards with
center of knee wrap over center of the kneecap.
Hinges should sit on the sides of the knee.
Remove white backing from knee electrode
and adhere it to knee wrap as shown with
wire extending downward. Center the round
area in the middle of the electrode over the
kneecap (4). The white side of the electrode
should be against brace or liner and black
side goes against the skin.*
1c
2
1b
3
4
*For demonstration purposes, electrodes are shown here in a contrasting color.
10
BioniCare® Knee System
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STEP 5. Apply the brace (See application
instructions for Catalyst•Propel OA).
Remove the clear backing from both
electrodes. With the knee bent at 45
degrees, gently push the knee wrap over
the knee to create a “reverse bubble”(5).
Be sure the center of the knee wrap and
Preparation and Treatment (cont.)
5
1b
2a
1a
2b
SIDE VIEW
KNEE
CALF
*For demonstration purposes, electrodes are shown here in a contrasting color.
center round part of the electrode are directly over the center of the
kneecap. Fasten straps in numerical order and continue applying the
brace per the Catalyst•Propel OA application instructions.
BioniCare Night-Wrap Application Guide:
STEP 1. Install electrodes on the BioniCare
Night-Wrap. Lay the Night-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 off the
white paper backing and adhering the elec-
trode 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 off the
white paper backing (1a) and adhering 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 Night-Wrap.
Remove the clear backing from both elec-
trodes (2a). Position the wrap so that the
electrodes are facing leg (keep long strap
closer to the waist).
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BioniCare® Knee System
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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.
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. See Figure 1 and 2, to attach this Wire:
1. Connect the two color coded lead wire ends to the electrode wires.
Make sure the BioniCare Generator is turned off. 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.
2c
LEAD WIRE
2d
LEAD WIRE
Figure 1 Figure 2
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BioniCare® Knee System
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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 off (4 second hold to turn off)
• 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
14
BioniCare® Knee System
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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
123
45
6
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BioniCare® Knee System
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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.
!
Description of data collection and transmitting functions:
• Record patient progress via simple survey questions on the
generator display
• Automatic upload of patient progress data to BioniCare website
to track performance and outcome measurements
18
BioniCare® Knee System
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Is it harmful to wear my Device more than 10 hours a day?
No. There has been no evidence that it is harmful to wear the device
more than 10 hours a day. In fact, studies show that the more the
device is worn, the sooner you will see significant results. (See
below FAQ regarding break-in schedule.)
What is the recommended break in schedule for a new brace
with BioniCare?
It’s important that you allow your body to adjust to a new brace
(or new brace with BioniCare) by starting out slowly and gradually
increasing your wear time. On day one, wear the brace for one hour,
and each day going forward, double the amount of time until you
reach your optimal daily wear time. For example, on the first day
wear it for one hour, on the second day for two hours, on the third
day for four hours, and the fourth day for eight hours. This will allow
your body to more easily adapt to the new corrective pressures and
improved biomechanics that are provided by the brace.
How often do I need to recharge the battery?
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.
What are the side effects, if any?
There are no serious side effects associated with the BioniCare system.
Some patients develop a mild rash under the Electrodes or Wrap.
What can I do to prevent a skin rash?
Take special care of the skin underneath the electrodes and Knee Wrap.
After a treatment, wash the skin with warm water and mild soap. Then
rub in a quality moisturizing lotion, preferably with aloe vera, or an
over-the-counter hydrocortisone cream. Make sure to completely wash
the lotion/cream from skin before re-applying the electrode.
How do I get new supplies of electrodes and batteries?
In the US, just call our Patient Services Center toll-free at
800.444.1456, Mon. - Fri., 7 a.m. - 6 p.m. (PST) or log online,
www.BioniCare.com/supplies. Outside the US, please contact
your BioniCare provider or your healthcare practitioner.
Q.
A.
Q.
A.
Q.
A.
Q.
A.
Q.
A.
Q.
A.
Frequently Asked Questions
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BioniCare® Knee System
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How frequently should I reorder electrodes?
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.
Can the knee wrap and liners be washed and dried?
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.
I can’t feel the tingle during setup, what do I do?
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.
Once symptoms improve, can I stop using my Knee Device?
Once you have been pain free for three months, we recommend a
maintenance regimen where BioniCare is used for 8 hours per week.
How long will my symptoms remain improved?
Symptom improvement varies, so it’s best to use the recommended
maintenance regimen of one 8 hour treatment per week.
Q.
A.
Q.
A.
Q.
A.
Q.
A.
Q.
A.
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BioniCare® Knee System
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Will my insurance cover the costs, and will VQ OrthoCare bill my
insurance company for me?
Insurance coverage varies. VQ OrthoCare reimbursement professionals
will help determine your insurance coverage, submit claims and follow
up for reimbursement. They will bill you if there is a co-pay or deductible
amount. In the case of no insurance coverage, they will work with you
to discuss payment options. They will answer any questions you have
about this process and your responsibilities. Outside the US, please
contact your BioniCare provider.
Who do I contact if I have an insurance or billing question?
In the US, call VQ OrthoCare at 800.444.1456. Outside the US,
please contact your BioniCare provider.
Frequently Asked Questions (cont.)
Q.
A.
Q.
A.
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BioniCare® Knee System
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Problem: BioniCare Generator displays the “OPEN” message.
This is a common occurrence that can be easily corrected. The OPEN
message is an indication that there is an incomplete circuit within the
electrical system. The circuit consists of the BioniCare Generator, Wire
and electrodes and connection to your skin. If one piece of this circuit
is not connected, the BioniCare Generator will read OPEN. The likely
suspects are the Wires or electrodes.
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 a
re 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.
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 condi-
tion 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.
Troubleshooting
22
BioniCare® Knee System
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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 batterycharger 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 off.
If your Generator shuts off, you may have accidentally turned it off 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 off 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/
Off 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/Off button.
Problem: You can’t feel the tingle when you increase the signal. There
are a few reasons for this to occur.
1. Your setting is too low. Increase the output until the signal is felt. It’s
normal for the voltage setting to change from day to day, depending
on how long the electrodes have been used and the condition of your
skin.
2. Your skin might be too dry. Use moisturizer after each therapy session
on the area of the skin under the electrodes.
3. It is quite common for some patients to not feel the tingle even at the
highest voltage setting. Do not worry as this is normal. Set the voltage
to 8.4 volts to receive your treatment. Remember to ramp up the
voltage for each treatment as your sensitivity may change over time.
Troubleshooting (cont.)
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BioniCare® Knee System
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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.
• 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.
Brace Knee Wrap/Thigh Liner and Night-Wrap
To clean the above soft goods, the electrodes should first be removed and
the brace liner/wrap should be removed from the brace. They should be
hand washed in cold water with mild detergent. Rinse thoroughly and
air-dry (do not machine dry). Never machine wash the soft goods. Never
use bleach, fabric softener, or harsh detergents. The other brace liners and
straps should be washed in the same manner.
Care and Cleaning
24
BioniCare® Knee System
ENGLISH
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 affect the even distribution
of stimulation.
• 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.
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 office.
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.)
ENGLISH | 25
BioniCare® Knee System
ENGLISH
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
Figure 5
26
BioniCare® Knee System
ENGLISH
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.
Operating Conditions
• Temperature: 5° C - 40° C
• Relative Humidity: 15% - 93%
• Atmospheric Pressure: 700 to 1060 hPa (0.69 to 1.05 atm)
Storage and Transport
• Temperature: -25°C - +70°C
• Relative Humidity: 30 - 93%
• Atmospheric Pressure: 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 affects when
exposed to dripping at 15 degree tilt.
ENGLISH | 27
BioniCare® Knee System
ENGLISH
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 affect 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
28
BioniCare® Knee System
ENGLISH
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: UT is the a.c. mains voltage prior to application of the test level.
EMC Compliance Table (cont.)
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.
ENGLISH | 29
BioniCare® Knee System
ENGLISH
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
affected 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.

Produktspecifikationer

Varumärke: VQ OrthoCare
Kategori: Diverse
Modell: BioniCare Knee System

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