VQ OrthoCare BIONICARE KNEE SYSTEM User manual

QUICK START GUIDE
BIONICARE KNEE SYSTEM +OACTIVE®2

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1. BioniCare Wrap
2. Thigh Electrode
3. Knee Electrode
4. BioniCare Device
5. (2) Rechargeable Batteries
6. Lead Wire
7. Battery Charger
8. BioniCare Device Holster
9. Brace Thigh Liner
10. Brace Knee Wrap
11. Bluetooth Dongle (optional)
YOUR OACTIVE®2 BIONICARE KNEE SYSTEM INCLUDES:
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If you have any questions about the use of the BioniCare Knee System,
please call our Patient Care Department at 800.452.7993
Congratulations on your BioniCare Knee System—
the only non-invasive treatment for osteoarthritis of the knee
that improves the knee, defers knee replacement and reduces medications!
The BioniCare Knee System involves the use of a therapeutic electrical current that mimics the signal of a healthy
knee to treat osteoarthritis. It takes daily use over several weeks to feel a reduction in pain and an improvement in
functioning. The device should be worn subsensory (you should not be able to feel it). Most patients will NOT FEEL
ANYTHING even at the maximum intensity. You can check the device to make sure it is sending the signal out, but you
will know that it is working by the improvements you see in your knee.

FRONT BACK
BACK VIEW
LEAD WIRE PORT
SIDE VIEW
LEAD WIRE
STEP 1:TAKE THESE ITEMS STEP 1a:Press battery door
up to open and lift o. INSERT
battery into the device. Slide door
to close.
STEP 1b:INSERT lead wire into
the BioniCare device
1 Lead wire
45
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1 BioniCare Device
1 Rechargeable
Battery
BACK VIEW
SIDE VIEW
THIS SIDE UP
2
3
Knee Electrode
Thigh Electrode
STEP 3:Attach knee wrap to brace. With the pointed
end of the condyle pocket pointed towards the kneecap,
pull the wrap over the condyle cap.
STEP 2:TAKE THESE ITEMS
Make sure the condyle cup/pad is completely covered by the wrap.
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Brace Knee Wrap
Brace Thigh Liner
CONDYLE CUP
FRONT
FRONT

STEP 5a:Apply thigh electrode to thigh liner.
Peel WHITE backing o thigh electrode and adhere
electrode to the center of the thigh liner with white
side against liner and black side facing out.
STEP 4: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
during your fitting by a technician. TIP: Make sure that the wire extends toward the top of the liner.
CLEAR PLASTIC
WHITE
SIDE
WHITE
BACKING
BLACK SIDE
 
OACTIVE 2
LINER
OACTIVE 2
LINER BIONICARE
OACTIVE 2
LINER
STEP 6:Apply brace to leg, as detailed in brace
application instructions. Leave knee wrap open.
STEP 5b:Peel CLEAR backing o the thigh electrode.
NOTE: The white side of the electrode should be against the
liner and the black side should be against the skin.

STEP 7: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. Then press entire electrode firmly to skin.
Peel white backing o electrode. The WHITE side of
the electrode should be against wrap and BLACK side
goes against the skin.
45˚
STEP 9:Attach red lead wire tip to the knee electrode
and the black lead wire tip to the thigh electrode.
STEP 8:Apply knee wrap around the knee and
secure in front with velcro tab.
TIP: You can tuck the lead wire in the brace straps
to route wire upward towards thigh. Match red to red and black to black.

WHITE
SIDE

STEP 10:Press middle button to turn on device.
Press the unlock icon on screen to unlock.
TIP: Middle button will also unlock screen.
STEP 11:Answer the following questions.
Your device will periodically ask 4 questions to chart your
progress. Press the middle button to answer and the side
buttons to scroll through answer options.
STEP 12:Press play button to start treatment.
Increase past 2.0 volts then continue to increase
until you feel tingling. Then DECREASE until you
no longer feel tingling.
It’s okay if you do not feel tingling even at 12.0 volts.
The BioniCare device is still administering treatment.
To save battery life, set treatment at 8.0 volts.

 
Recommended treatment time in the brace is 30-60 minutes on the first day
and increasing after that as you adjust to wearing the brace. The BioniCare
signal should be worn a minimum of 8-10 hours a day. It can be used in the
BioniCare wrap when the brace is not being worn. The more hours you treat
with the BioniCare signal, the sooner you will see improvements in your knee.
NOTE: If your device says “OPEN” after you get past 2.0 volts, the device is not
connected correctly or not making good contact.
• Make sure white side of electrode is against wrap and black gel is against
skin (Thigh Electrode: STEPS 5a and 5b; Knee Electrode: STEPS 7 - 8).
• Make sure electrodes are stuck to skin (STEPS 6 and 7) and wires are all
connected (STEPS 1B and 9).
• If electrodes are old, replace your electrodes.
If you cannot get the OPEN error to stop, try the troubleshooting section of the
manual or call Patient Care at 800.452.7993.

QUICK START GUIDE
BIONICARE KNEE WRAP SYSTEM
FRONT BACK
BACK VIEW
LEAD WIRE PORT
SIDE VIEW
LEAD WIRE
STEP 1:TAKE THESE ITEMS STEP 1A:Press battery door
up to open and lift o. INSERT
battery into the device. Slide door
to close.
STEP 1B:INSERT lead wire into
the BioniCare device
1 Lead wire
45
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1 BioniCare Device
1 Rechargeable
Battery
BACK VIEW
SIDE VIEW
THIS SIDE UP

2
3
1 BioniCare Wrap
2 Knee Electrodes
2 Thigh Electrodes
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STEP 3:Lay Wrap on table with 1 KNEE and 1 THIGH
electrode.
STEP 5:Peel CLEAR backing o each electrode.
STEP 2:TAKE THESE ITEMS
STEP 4:Peel WHITE backing o knee electrode and
apply within outlines on BioniCare Wrap.
REPEAT: Repeat process for thigh electrode
TIP: KEEP plastic sheets to reapply on electrodes after each use.
KNEE
ELECTRODE
THIGH ELECTRODE
GOES HERE
NOTE: The white side of the electrode should be against
the wrap and the black side goes against the skin.

STEP 7:Wrap top and bottom straps around leg.
STEP 9:Press middle button to turn on device. Press
the unlock icon on screen to unlock.
STEP 6:Apply BioniCare Wrap to knee.
STEP 8:Attach red lead wire tip to the knee
electrode and the black lead wire tip to the thigh
electrode.
Line up circle of knee electrode over your kneecap and thigh
electrode over your thigh with electrodes sticking to skin.
Match red to red and black to black.
Wires should extend downward
and upward from the BioniCare Wrap.
TIP: Middle button will also unlock screen.
WIRE
WIRE
SIDE VIEW
KNEE
CALF
THIGH
KNEE


STEP 11:Press play button to start treatment.
STEP 10:Answer the following questions.
STEP 12:Increase past 2.0 volts then continue to
increase until you feel tingling. Then DECREASE until
you no longer feel tingling.
Your device will periodically ask 4 questions to chart your
progress. Press the middle button to answer and the side
buttons to scroll through answer options.
It’s okay if you do not feel tingling even at 12.0 volts.
The BioniCare device is still administering treatment.
To save battery life, set treatment at 8.0 volts.
Recommended treatment time is a minimum of 8 hours a
day. However, the more hours you treat with the BioniCare
System, the sooner you will see improvements in your knee.
NOTE: If your device says “OPEN” after you get past 2.0 volts, the
device is not connected correctly or not making good contact.
• Make sure white side of electrode is against wrap and black gel is
against skin (STEPS 4-5).
• Make sure electrodes are stuck to skin (STEP 6) and wires are all
connected (STEPS 1B and 8).
• If electrodes are old, replace your electrodes.
If you cannot get the OPEN error to stop, try the troubleshooting
section of the manual or call Patient Care at 800.452.7993.


SIDE VIEW
BIONICARE WRAP SYSTEM REMOVAL STEPS
STEP 1: Detach BioniCare Wrap and
carefully peel from knee.
STEP 2: Place clear plastic backing onto
knee and thigh electrodes for protection
when not in use.
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.
BIONICARE SYSTEM + OACTIVE 2 REMOVAL STEPS
STEP 1: Detach knee wrap 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 knee 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.
CARE AND MAINTENANCE
ELECTRODES
• Always replace clear plastic backings on electrodes after each use.
• Do not use alcohol to clean skin surface.
• Electrodes should only be used on dry, clean, unbroken skin surfaces. Prior to
BioniCare Wrap application wash skin with soap and water and completely dry.
• Do not apply skin lotion prior to application of BioniCare Wrap.
• Do not trim electrodes, as cut edges may aect the even distribution of
stimulation.
• Remove BioniCare Wrap before showering.
• If you experience symptoms of skin irritation while using the BioniCare system,
discontinue use immediately and contact VQ OrthoCare’s Patient Care
Department at 800.452.7993, or consult your BioniCare provider or healthcare
practitioner.
CAUTION
Electrodes should be discarded and replaced if damaged or if they show signs
of wear. If in doubt about the integrity or proper function of any electrode,
replace it before proceeding with treatment.
BIONICARE WRAP AND OACTIVE 2 LINERS
To clean the wrap and liners, the electrodes should first be removed. The wrap
and liners should be hand washed in cold water with mild detergent. Rinse
thoroughly and air dry (do not machine dry). Never machine wash the wraps and
liners. Never use bleach, fabric softener, or harsh detergents.
FOR QUESTIONS OR TROUBLESHOOTING PLEASE CALL
800.452.7993 TO SPEAK TO A BIONICARE REPRESENTATIVE
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@BioniCare
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© 2019 VisionQuest Industries, Inc.
VQO511977REVD
EMERGO EUROPE
Prinsessegracht 20
2514 AP The Hague
The Netherlands
NOTES:
INDICATIONS: 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 place-
ment that applies current to the carotid sinus (neck) region.
• Do not use the BioniCare Knee System for any electrode place-
ment that causes current to flow transcerebrally (through the
head).
• Do not use the BioniCare Knee System when pain syndromes
are undiagnosed until etiology is established.
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.
WARNINGS
• The BioniCare Knee System must be used only as prescribed
and applied only to the knee.
• Patients with demand style 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 eective 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 Device is in use.
WARNINGS: If you experience pain, swelling, sensation
changes, or unusual reactions while using this product, contact
VQ OrthoCare’s Patient Care department at 800.452.7993 or
consult a physician.
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 the device.
BIONICARE KNEE SYSTEM
QUICK START GUIDE
FOR OTHER LANGUAGES PLEASE FOLLOW THESE LINKS:
VERSION EN ESPAÑOL
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VERSION FRANÇAISE
bu.ly/2WiODpo
1390 Decision Street, Suite A • Vista, CA 92081 • USA
EU Manufacturer:
18011 Mitchell South, Suite A • Irvine, CA 92614 • USA
800.266.6969 • www.vqorthocare.com