VQ OrthoCare BioniCare Hand System User manual

BioniCare®Hand System
Operating Manual
Manual de Instrucciones
Manuel D’utilisation
18011 Mitchell South, Irvine, CA 92614
Call 949.266.6969 Fax [phone]
www.vqorthocare.com
[email protected]
© 2015 VisionQuest Industries, Inc.
VQO511704REVB
MANUFACTURED AT
1390 Decision St, Suite A
Vista, CA 92081, USA

BioniCare®Hand System
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 Hand System
for the treatment of Rheumatoid Arthritis of the Hand
US 5,273,033; CA 2,102,759; EP 0652028;
EE. UU. 5,273,033; CA 2,102,759; EP 0652028;
US 5,273,033; CA 2,102,759; EP 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 mano BioniCare
para tratamiento de la artritis reumatoide de la mano
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 la main BioniCare
pour le traitement de la polyarthrite rhumatoïde
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ESPAÑOL
FRANÇAIS

BioniCare®Hand System
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Table of Contents
How Much Relief................................................................. 2
Prescribing Information......................................................... 3
Introducing the BioniCare Hand System................................ 4
System Components............................................................. 6
General Operating Instructions ............................................. 7
Preparation and Treatment.................................................... 7
BioniCare Generator Features & Functions ............................ 9
Basic Use Screens ................................................................ 10
Keys to Treatment Success.................................................... 12
Frequently Asked Questions ................................................. 13
Troubleshooting ................................................................... 15
Care and Cleaning................................................................ 17
Basic Specifications.............................................................. 19
EMC Compliance Table ....................................................... 21
U.S. and International Safety Standards ................................. 23
One Year limited Warranty ................................................... 24
Manual de Español............................................................... 27
Manuel de Français .............................................................. 53
Notes................................................................................... 78

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BioniCare®Hand System
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How much relief of my arthritis will I receive with
the BioniCare 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®System to treat osteoarthritis of the knee or rheumatoid arthritis of
the hand. 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 or hand won’t happen overnight. To be
successful, they commit to using their device for at least 6 to 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 function. 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®Hand System
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Prescribing Information
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician
or any other practitioner licensed by the law of the State in which he practices.
Indication
The BioniCare Hand System is indicated “for use as an adjunctive therapy in reducing
the level of pain and stiffness associated with pain from rheumatoid arthritis of the
hand.”
Contraindications
• Do not use the BioniCare Hand System for any electrode placement that
applies current to the carotid sinus (neck) region.
• Do not use the BioniCare Hand System for any electrode placement that
causes current to flow transcerebrally (through the head).
• Patients with demand type cardiac pacemakers should consult with their
physician prior to use of this system.
• Do not use the BioniCare Hand System whenever pain syndromes are
undiagnosed, until etiology is established.
Warnings
• The BioniCare Hand System must be used only as prescribed and applied
only to the hand.
• The safety of the BioniCare Hand System for use during pregnancy has
not been established.
• The BioniCare Hand 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 Hand Device is in use.
Precautions
• Isolated cases of skin irritation may occur at the site of conductors and
conductive glove placement following long-term application.
• Effectiveness is highly dependent upon patient selection by a physician
qualified in the management of arthritis.

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BioniCare®Hand System
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The BioniCare System is prescribed by physicians and other medical
professionals to treat rheumatoid arthritis of the hand. It is a non-drug,
noninvasive therapy delivering a unique electrical impulse. The
BioniCare BIO-2000 Generator (Signal Generator) sends this low
voltage impulse to the hand via a conductive system comprising a
conducting glove and individual conductors placed over each finger tip.
People diagnosed with rheumatoid arthritis of the hand who regularly use
the BioniCare 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.
BioniCare Hand System
Introducing the BioniCare Hand System
BioniCare Glove
BioniCare Generator
Generator Dock
Conductors

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BioniCare®Hand System
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( ) Select Button
Touch Screen Display
Navigation Buttons
Output Jack
Output Jack
Battery Compartment
Serial Number Label
Front View
Back View
Top View

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BioniCare®Hand System
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System Components
(1) BioniCare Generator (Signal Generator)
(1) Generator Dock
(1) BioniCare Glove
(1) Battery Charger
(2) Rechargeable Batteries
(3) Conductor Packs (shown on page 4)
(1) Bluetooth Dongle
BioniCare Generator
Battery Charger Rechargeable Battery Bluetooth Dongle
BioniCare Glove
Generator Dock

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BioniCare®Hand System
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General Operating Instructions
This section describes the operation of the BioniCare Hand System for
the treatment of rheumatoid arthritis of the hand. Each patient should read
and become completely familiar with the written operating instructions.
Charging the Battery for the Signal Generator:
The Signal Generator is powered by a single rechargeable Lithium Ion
battery. The battery charger 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 the BioniCare device, the wrist and hand must be washed
with soap and water. The wrist and hand do not need to be dried completely;
they can be left moist. Remove all jewelry form the hand and wrist.
Preparation and Treatment
• Remove all jewelry from the area to be treated.
• Do not apply to broken skin or open wounds.
• Do not use the glove if it is torn.
• Do not use if the outside of the glove gets wet. Wait until it is completely dry.
• Stimulation should not be applied while operating a motor vehicle or machinery.
WARNING
!
Conductors:
Apply the fingertip conductors over the ends of each finger. Apply the square
conductive pad on the inside of your wrist, approximately 2 fingers width
from the wrist joint.

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Preparation and Treatment (cont.)
Applying the Generator Dock and Glove:
Pull the glove on the hand, making sure that your fingertips reach the ends of
the glove. Place the generator dock over the glove lining up the two velcro
dots with the strips of loop on the glove. Make sure that the straight edge of
the device is towards the hand and the curved edge is towards your elbow.
Attach the strap, placing the connector into the keyhole and pulling down to
secure. Adjust the elastic strap as needed to fit snugly on your wrist.
Starting Your Treatment
Check that the components are in place and all connections and adjustments
are correct.
1. Turn the Signal Generator on by pressing the Select/Power button until
BioniCare appears on the screen. The screen will then advance to the
main treatment menu.
2. Press the play button.
3. Increase the signal level by pressing the Increase Button on the
touch screen or the corresponding manual button. Increase the voltage
until you feel a tingling sensation in the hand or wrist.
Connecting the Device:
Slide the device into the generator dock as shown below. Press the device
in place, making sure that you hear a click that will secure it in place.

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BioniCare®Hand 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 rheumatoid arthritis of the hand.
Manual Buttons
There are 3 manual push buttons that control functions on the device.
Select ( ) Button functions:
• Turns the power on or off (3 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 voltage amplitude
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 voltage (measured in tenths of a volt)
• View overall hours of treatment
• Check battery charge
• Unlock device
• Control settings of device parameters
BioniCare Generator Features & Functions
Press the Decrease Button on the touch screen or the corresponding
manual button a few times to reduce the stimulation level just
enough so you no longer feel the tingling sensation. You have now
begun your treatment.
Note: If the Signal Generator voltage is set below 2.0 V, the device will begin to
beep after 5 minutes and will turn off after 10 minutes.
4.

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BioniCare®Hand 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 voltage)
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®Hand System
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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
Questions Screen
At the start of treatment and every 125 hours of treatment, you will be
asked a series of 4 questions. These questions ask you to rate your pain and
evaluate the effect the BioniCare treatment has had on your medication
intake, activity level and quality of life. Press ( ) to see first question.
Press  to scroll through answers. Press ( ) to select answer. Repeat
for next three questions. When finished, the main display screen will show.
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 recharged battery.
You should turn off the stimulation when changing batteries.
Open (circuit): An “Open” circuit message will be displayed and an
audible beep will sound if (1) the device becomes disconnected with
the generator dock or (2) the generator dock and glove are not properly
connected.
NOTE: This display can only be accessed when amplitude is 0 Volts

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BioniCare®Hand System
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Keys to Treatment Success
Complying with your doctor’s prescription of daily treatments is the most
important key to your success. These Keys to Success will help you receive
maximum benefit from your BioniCare Hand System.
Use daily. Take a treatment with your BioniCare Hand System for at least
6-10 hours each day or as much as possible. Some patients may find that
sleeping in the device as well as daily use provides the maximum number
of hours of treatment.
Charge the batteries. Use a fully charged battery each day. Two batteries
are supplied so that one can be charging for 4 hours while the other is in
use.
Adjust the signal for each treatment. You may not be at the same voltage
level every day. Turn the Signal Generator on and increase the voltage
until you feel a tingle under the hand or wrist conductor. Then, slowly turn
the voltage down until you feel no tingle.
Renew supplies. Order replacement gloves every 6 months or as needed.
Order fingertip conductors monthly or as needed.
1.
2.
3.
4.

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BioniCare®Hand System
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Frequently Asked Questions
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, patients who use the device for more
hours per day tend to see results sooner.
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?
TherearenoserioussideeffectsassociatedwiththeBioniCaresystem.Some
patients develop a mild rash under the Conductive Glove or Conductors.
I have a rash under the conductors. How do I treat it?
A skin rash may be caused by the conductors or conductive glove. If you
develop a rash, stop treatment for a few days. You may need to treat for
fewer hours per day. Do NOT continue treating if you develop a rash
or irritation under the conductors or conductive glove. Many users find
it helpful to apply an over-the-counter topical hydrocortisone cream to
the rash; you may choose to check with your doctor. If the rash persists,
check with your doctor.
What can I do to prevent a skin rash?
Take special care of the skin underneath the glove and conductors. 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 glove or conductors.
How frequently should I reorder supplies?
Your glove should last at least 6 months. It should be replaced earlier
if you see signs of wear and tear. Routine visual inspection of the glove
condition is recommended. Conductors should be replaced when they
has worn off. These should last approximately one week.
How do I get additional supplies?
In the US, just call our Patient Services Center toll-free at 800.444.1456,
Monday-Friday, 7 a.m. - 7 p.m., Saturday, 8 a.m. - 4:30 p.m. Pacific
Time. Outside the US, please contact your BioniCare provider or your
healthcare practitioner.
Q.
A.
Q.
A.
Q.
A.
Q.
A.
Q.
A.
Q.
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Q.
A.

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Frequently Asked Questions (cont.)
Can the glove be washed and dried?
Yes the glove can be hand washed and air dried. 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 components through the washer
or dryer. Never place your Signal Generator, generator dock, battery or
battery charger in water; these items can be wiped clean with a damp
cloth or cotton swab.
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 Device?
Once you have been pain free for three months, you can gradually
decrease the number of hours and days that you use the device.
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.
Who do I contact if I have an insurance or billing question?
Take special care of the skin underneath the glove and conductors. 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 glove or conductors.
How frequently should I reorder supplies?
In the US, call VQ OrthoCare at 1.800.444.1456. Outside the US, please
contact your BioniCare provider.
Q.
A.
Q.
A.
Q.
A.
Q.
A.
Q.
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BioniCare®Hand System
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Troubleshooting
Problem: Signal 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 Signal Generator, generator
dock, conductors and glove. If one piece of this circuit is not connected,
the signal Generator will read OPEN.
Check all connections to the signal generator, generator dock and glove.
Make sure that the battery door is properly closed.
Make sure that the device is securely snapped into the plastic case of
the generator dock.
Use a new set of conductors if they show signs of wear or are more than
7 days old.
If after you’ve checked these solutions the Signal 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. Many patients find relief by treating the area with an over-
the-counter hydrocortisone cream until the rash is gone, usually in 5-7 days;
you may choose to check with your doctor. Some patients may be allergic
to the conductors or glove 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 1.800.444.1456. 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.
1.
2.
3.
4.
5.

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Troubleshooting (cont.)
Problem: Battery will not hold a charge.
Your signal 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. Keep
one battery charging at all times; you may want to label your batteries A
& B and keep track of which battery you use for each treatment. If you’re
travelling overseas be sure to get a converter/adapter for the charger.
Problem: Display is blank and the Signal Generator shuts off.
If your Generator shuts off, you may have accidentally turned it off.
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 recharged battery and check the user time. Eight hours of treatment is
normal. Additionally, 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.

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Care and Cleaning
Signal Generator
The case of the Signal Generator may be cleaned with a cloth and cotton
swab. The Signal Generator should be turned “OFF” and not connected
to the generator dock when cleaning. Do not use liquids for cleaning; the
Signal Generator is not waterproof. The Signal Generator case must not be
opened by removing the screws, because there are no operator serviceable
components inside. Always store the Signal Generator in a clean, dry area
between 0° and 140°F.
• Factory manufactured conductive garments have been designed
and authorized specifically for use with this product and must not be
manipulated or altered in any way.
SIGNAL GENERATOR CAUTIONS
• Do not connect the Signal Generator to any electrical outlet.
• Remove the battery from the Signal Generator during long-term
storage to prevent battery leakage. Failure to do so may damage
the Signal Generator.
• Replace batteries immersed in water or liquid. Failure to do so
may damage the Signal 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.
!

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Care and Cleaning (cont.)
Care and maintenance of conductors
• Do not use alcohol to clean skin surface.
• Conductors should only be used on dry, clean, unbroken skin
surfaces. Prior to application wash skin with soap and water.
• Do not apply skin lotion prior to application.
• Do not trim conductors, as cut edges may affect the even
distribution of stimulation.
• Remove conductors before showering.
• When removing conductors, place them on plastic liner and place
the plastic liner in the resealable pouch.
• If you experience symptoms of skin irritation while using the BioniCare
®
Hand System, discontinue use immediately and in the US, contact
VQ OrthoCare’s Patient Care department at 1.800.444.1456,
or consult your healthcare practitioner. Outside the US, please
contact your BioniCare provider or your healthcare practitioner.
Service
Do not return the BioniCare Hand Device to your physician’s office.
This Signal Generator contains no user serviceable parts and must be
returned to VQ OrthoCare or its representatives for service, repair or
calibration at its factory.