BIOMET EBI Bone Healing System User manual

The Biomet®EBI Bone Healing System
Patient Manual

B
Contents
Introduction................................................................................. Page 1
Symbol Description.................................................................. Page 2
Warnings..................................................................................... Page 3
Battery Warning ....................................................................... Page 5
Indications, Contraindications, Usage and Adverse Effects......... Page 7
Indications: .............................................................................. Page 7
Contraindications:.................................................................... Page 7
Usage:...................................................................................... Page 8
Adverse Effects: ....................................................................... Page 8
What does a Bone Healing System do?....................................... Page 9
What comes in the System Kit?................................................... Page 10
Additional Components............................................................... Page 12
SFLX Flexible Therapeutic Treatment Coils............................... Page 12
International Wall Plug Blade Adapter Kit................................. Page 12
Extremity Band......................................................................... Page 13
How do I connect my control unit to my treatment coil?............. Page 14
How do I start my treatment?...................................................... Page 15
How do I charge my battery?....................................................... Page 18
Cleaning Instructions .................................................................. Page 19
The Control Unit....................................................................... Page 19
Therapeutic Treatment Coils..................................................... Page 19
Treatment Completion................................................................. Page 19
Disposal...................................................................................... Page 20
What if I have questions?............................................................ Page 20

1
Introduction
This manual presents a complete overview of how to use your Bone
Healing System safely and effectively. The manual is intended to
complement the one-on-one training you’ll be receiving by a fully
trained professional prior to starting your treatment. Please read
through the entire manual before operating.
Biomet is committed in providing every opportunity to you to achieve a
successful outcome. If you have any questions or concerns regarding
your Bone Healing System or one-on-one personal training please feel
free to contact Biomet directly or your local sales representative at
any time.

2
Symbol Description
!Warning Reset
*NOTE: Important additional
instruction Backlight
Type B Equipment On/Off
Direct Current Rx
Only Prescription Only
Alternating Current Manufacturer
Attention – See Instructions
Not for use by patients
who are pregnant or
becoming pregnant
Non-ionizing Radiation
Not recommended for
patients with certain types
of pacemakers or
implantable defibrillators
Class II Temperature range for
storage and transportation
Single Patient Use /
Single Prescription
Lithium Ion Battery –
Recycle in compliance
with local laws
WEEE – Do not dispose
of this device with
household waste
The Biomet®EBI Bone
Healing System has not
been tested for safety or
been evaluated for heating
in the MR environment.
Charge Battery
2

3
Warnings
! Warnings:
To reduce the risk of electric shock, fire or potential injuries please
adhere to the following:
1. Do not use your bone healing system while bathing.
2. Do not place or store your bone healing system where it can fall or
be pulled into a tub, sink or any pool of liquid.
3. Do not immerse or drop your bone healing system’s control unit,
treatment coil, AC Wall Adapter, in any liquid.
4. Do not reach for your bone healing system that has fallen into a
liquid. Unplug from the wall outlet immediately.
5. Do not permit the AC Wall Adapter to be connected when wet.
6. Never touch the AC Wall Adapter contacts when the AC Wall
Adapter is plugged into an AC Wall outlet.
7. Do not place the AC Wall Adapter in the bed with you if you are
treating while you are sleeping.
8. Never operate your bone healing system if it has a damaged link
cable, cord or plug, if it is not working properly, if it has been
dropped and damaged, or immersed into any liquid. Contact
Biomet immediately for a replacement part(s).
9. Keep all electrical cords and cables away from heated surfaces.

4
Warnings (Continued)
10. Keep the Bone Healing System and its accessories away from
small children. This device is not a toy and may be hazardous
to children.
For example:
   • Achokinghazardmayexistfordetachableparts
   • Improperusecouldresultinexposuretoatreatmentsignal
for which the risks of exposure to children have not
been established
11. Never insert any object into any opening of your bone
healing system.
12. Do not place your bone healing system’s control unit in prolonged
heat or direct sunlight. (Normal operating temperature range is
5°C to 38°C,[41°F to 100°F], 20-80% RH non-condensing, normal
storage/transport temperature is -15°C to 60°C [5°F to 140°F].)
13. Use your bone healing system only for its intended use as
prescribed by your physician and described in this manual.
14. The safe operation of Durable Medical Electrical Equipment
requires adherence to special precautions regarding
Electromagnetic Compatibility (EMC) in accordance
with information provided in the physician manual.
15. No modification to this device is allowed for any
reason whatsoever.
16. Routine use of bone healing systems for over 30 years has
demonstrated that any known hazard associated with their use
does not present an unreasonable risk of illness or injury when
compared to the benefit of their use.
17. Use of your bone healing system for the spine and skull has not
been evaluated or approved.

5
Battery Warning
CAUTION: The Biomet®EBI Bone Healing System control unit contains
a permanently installed Lithium Ion battery. You must read and follow
these safety instructions and warnings provided within this manual
before using or charging the battery within your control unit.
• Donotattempttoopenthecontrolunittoaccessthebatteryorits
internal electronic components for any reason. No unauthorized
modification of the control unit is allowed.
• Neverattempttochange,adjustorreversethebattery’spolarity
connections for any reason
• Donotalloworpermitthecontrolunitoritspermanentlyinstalled
battery to be physically mishandled, abused, crushed, mutilated or
penetrated by any metal object such as a nail
• Neveralloworpermitanymetalobjecttotouchorcontactthe
permanently installed battery’s terminals
• Neverstorethecontrolunitorchargethebatteryin
extreme temperatures
• Neverchargethebatteryunattended
• Alwayskeepthecontrolunitawayfromchildren

6
Battery Warning (Continued)
Any abuse or misuse to the control unit or its permanently installed
battery may result in serious personal injury and/or property damage.
Biomet is not liable for any such abuse, misuse or resulting damage.
To ensure proper charging, ONLY USE the AC Wall Adapter supplied
with your device system and follow the specific operating instructions
provided within this manual. Always keep the control unit and its
permanently installed battery dry. When all treatment has been
completed, the control unit and permanently installed battery MUST BE
disposed of properly. In the USA, disposal information may be obtained
by contacting the Rechargeable Battery Recycling Corporation Hotline
(RBRC) at 1-800-822-8837. Please contact local recycling authorities
for proper disposal information and instructions if outside the USA.
Never dispose in normal household waste or refuse.
Normal charging temperature range is 50°F (10°C) to +95°F (35°C).

7
Indications, Contraindications, Usage and Adverse Effects
Indications:
1. The Biomet®EBI Bone Healing System is indicated for the
treatment of fracture nonunions, failed fusions, and congenital
pseudarthrosis in the appendicular system. A nonunion
is considered to be established when there are no visibly
progressive signs of healing.
Contraindications:
1. Under certain conditions, electromagnetic stimulation
generated by a bone healing system could inhibit the output
of some demand pacemakers or implantable defibrillators.
Therefore, it is not recommended for patients with certain
types of pacemakers or implantable defibrillators. Patients
should be cautioned to avoid coming in close proximity
to pacemaker or defibrillator wearers during stimulation
treatment. The use of bone healing systems on pregnant
patients has not been evaluated; therefore, it is not
recommended in these cases. The long term effects of
exposure to low level magnetic fields created by bone healing
systems are not known.
2. Nonunion fractures in which a synovial pseudarthrosis (fluid
filled gap exists).
3. Use of the Biomet®EBI Bone Healing System on pregnant
patients has not been evaluated; therefore, it is not
recommended in these cases.
4. The Biomet®EBI Bone Healing System has not been tested for
safety or been evaluated for heating in the MR environment.
The effects of MRI procedures and scans using MR systems
has not been determined or established” therefore, MRI scans
and procedures should not be performed on patients until the
device system has been completely removed.
MR Unsafe-Not for MRI use!

8
Usage:
This Bone Healing System is a durable therapeutic electrical medical
device intended for single patient use only under a prescription.
Federal Law (U.S.A.) restricts this device to sale by or on the order
of a physician. Rx Only - Prescription Only - Single Use Only -
Not for Re-Sale or Re-Distribution - Do Not Reuse.
Adverse Effects:
The original EBI Bone Healing System®was approved and introduced
in 1979. Since then, over 600,000 systems have been marketed. The
safe and effective use of non-invasive bone growth stimulation devices
over this time has clearly established their therapeutic benefit of use.
In addition, all known hazards associated with the use of Bone Healing
Systems do not present an unreasonable risk of illness or injury when
compared to their therapeutic benefit and can be typically addressed by
either modifying or terminating treatment.
Indications, Contraindications, Usage and Adverse Effects
(Continued)

9
Your doctor has prescribed the Biomet®EBI Bone Healing System to
help heal your fracture nonunion or failed fusion. The Biomet®EBI
Bone Healing System is a proven, safe and effective medical device.
The system consists of an anatomically configured flexible treatment
coil that can be worn directly over a cast or worn over clothing or
directly on the skin during treatment. The system’s electronic controller
once connected to the flexible treatment coil via a link cable sends a
low-level electrical signal to the coil. The coil then converts this signal
into a pulsating electromagnetic field which is delivered directly to your
specific treatment site. The flexible coil is lightweight, easy to apply
and wear. The Biomet®EBI Bone Healing System is portable, battery
operated, easy to use and comes with an AC wall adapter for simple
battery recharging. You’ll be able to conveniently receive treatment
while going about your normal daily activities, routine or even
while sleeping.
What does a Bone Healing System do?

10
What comes in the System Kit?
• Electroniccontrolunit/controller-#1068233
• ControllertoCoilConnectorlinkcables:
  - “Zero”inchlinkcable-#1068210
  - 28inchlinkcable-#1068215
• Belt-#1068222
• ClipHolder-#1068208
• ACWallAdapter-#1068315
• Physician’sManual
• PatientManual
What does a Bone Healing System do? (Continued)
Biomet®EBI Bone Healing System Kit Contents

11
If at any point you need a replacement part for your Bone Healing
System please contact Biomet directly at 1.800.526.2579 and reference
the part number next to the description of the item you need to order.
28 Inch Link Cable
“Zero” Inch Link Cable
Physicians Manual Patient Manual
Controller
Clip
AC Wall Adapter

12
SFLX Flexible Therapeutic Treatment Coils
In addition to your Biomet®EBI Bone Healing System you have also
received an SFLX flexible therapeutic treatment coil. The coil you have
depends on the type and location of your fracture nonunion or failed
fusion your doctor diagnosed. To properly apply your flexible treatment
coil, please refer to the important user and safety instructions that were
included with the coil when you received it.
International Wall Plug Blade Adapter Kit
An international wall plug blade adapter kit is available for patients who
will be traveling outside the US and wish to continue their treatment
whileabroad.Thepartnumberis#1068317.
Additional Components

13
Extremity Band
An optional extremity band is also available if you would like to wear
your Bone Healing System’s electronic control unit closer to your
treatment site, for example on your arm. When ordering the extremity
band,referencepartnumber#1068209anditwillbeshippedtoyou
with important user and safety instructions.

14
How do I connect my control unit to my treatment coil?
First, connect the controller (A) to either the “Zero” inch or 28 inch
Link Cable (B). Then connect Link Cable (B) to the Treatment Coil (C).
The Link Cable selection depends on which cable length best fits your
specific treatment needs.
A
C
B

15
How do I start my treatment?
1) Place the treatment coil over your treatment site and adjust for a
comfortable fit.
* NOTE: Please refer to the important user and safety instructions insert
that came with your individual coil to adjust and complete proper
application and placement.
2) Once the treatment coil is adjusted, refer to the table below to turn
on your control unit.
Symbol Purpose Location
On/Off Button
Press once to turn on/off Button on the right, beneath the
display and Biomet logo
Backlight/Reset
Press once and release for the
display’s backlight to come on
Button on the left beneath
the display and Biomet logo
* NOTE: If you hold down the backlight button for two beeps, the
control unit will reset its internal clock to 00:00 treatment time for
the day.

16
3) The display on your control unit will scroll through the following
five messages.
FIRST MESSAGE:
Your compliance with the
recommended 10 hours per
day treatment is very important.
A review of the clinical data
demonstrated that less than the
recommended use may possibly
result in an increase in time to
heal. After you have used your
Bone Healing System for one full
treatment session, the control
unit will display the following:
SECOND MESSAGE:
How many hours per day on
average you used your system
THIRD MESSAGE:
How many days you have used
your system
FORTH MESSAGE:
How many days you have not
used your system
EBI RECOMMENDS
10 HOURS PER DAY
PATIENT USAGE
DAYS USED 000
PATIENT USAGE
DAYS UNUSED 000
How do I start my treatment? (Continued)
PATIENT USAGE
AVG HR/DAY 00:00

17
FIFTH MESSAGE:
The last message will display that
you are “TREATING “and for how
long. This message also displays
a “BATTERY” icon to show you
how much charge remains in your
control unit’s battery
4) After your Bone Healing System is operational and your treatment
has started, you can wear your control unit wherever is most
comfortable and convenient. Your Bone Healing System comes
with a belt-clip so you can clip and attach the control unit to your
waistband or belt. You can also request an optional extremity band
from Biomet if you would like to wear the controller closer to your
treatment site, for example on your arm.
* NOTE: The control unit must not be worn on the coil.
5) After 10 hours of use, your Bone Healing System’s electronic control
unit will automatically turn off.
* NOTE: Your Bone Healing System’s electronic controller is designed
to store your daily usage (treatment) information. This information
is extremely important to your doctor in determining your treatment
compliance. It’s recommended that you bring your Bone Healing
System and flexible treatment coil to each follow-up visit to allow your
doctor to review your healing progress.
IMPORTANT: Any medical questions regarding your treatment MUST be
addressed by your doctor.
TREATING 0:00
BATTERY

18
How do I charge my battery?
1) In order to charge your Bone Healing System’s battery, connect the
AC Wall Adapter (A) to the control unit (B) as shown:
2) Then, plug the AC Wall Adapter into an appropriate AC Wall outlet.
* NOTE: You are able to treat and charge at the same time. The display
on the control unit will indicate that you are still treating, but will also
indicate that the battery is charging. The battery may take up to 3.5
hours to fully charge.
A
B