Orthofix Cervical-Stim User manual

Cervical Fusion System
U.S.A. ED T ON
PA T I E N T M A N U A L

Orthofix nc.
U.S.A. Edition - Patient
P/N 571356-0001 Rev D 10/2009
Printed in U.S.A.
Date of Printing: 10/2009
CS-0906 PL-US © Orthofix nc.
Manufactured by:
Orthofix nc.
1720 Bray Central Drive
McKinney, Texas 75069
Tel [phone]
Customer Service
800-535-4492 toll free
www.orthofix.com

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Table of Contents
Cervical- tim®
Patient Manual
Glossary ...................................................................................................... 1
Prescription nformation .............................................................................. 3
Adverse Events ........................................................................................... 3
Device Description ...................................................................................... 5
Device Life .................................................................................................. 6
Treatment Time ............................................................................................ 6
Charging/Recharging the Battery ................................................................... 7
Device Operation ........................................................................................ 8
Wearing the Device ..................................................................................... 9
Care and Cleaning ....................................................................................... 10
Travel ........................................................................................................ 10
Storage ...................................................................................................... 10
Disposal ...................................................................................................... 10
Service ....................................................................................................... 10
Visual and Audio ndicators .......................................................................... 11
Equipment Classification and Device Symbol Descriptions ............................ 12
Clinical Data Summary ............................................................................... 13
Warranty nformation ................................................................................. 15
To learn more about Orthofix, please visit our website at www.orthofix.com.
Package Contents:
1- Cervical-Stim Cervical Fusion System
1- Literature Pack
1- Power Supply
1- Line Cord
TH S DEV CE S NONSTER LE.
T DOES NOT REQU RE STER L ZAT ON.

1
Glossary
adjunct/adjunctive: an additional therapy soon after the surgery
allograft: bone graft taken from another human
CT scan: Computerized Tomography Scan; a picture of structures within the
body created by a computer that takes the data from multiple x-ray images
and turns them into pictures on a screen
defibrillator: an electrical device used to restore normal heartbeat by
applying a brief electric shock
diabetes mellitus: a chronic disease in which the body has a lack of insulin
and cannot make use of carbohydrates
electrocardiogram: a recording of the electrical activity of the heart
epilepsy: also know as “seizure disorder”; a pattern of seizures caused when
the nerve cells in the brain fire electrical impulses at a rate of up to four times
higher than normal
fusion: the joining of two bones into a single unit and thus eliminating motion
between the two bones
high-risk patients: patients who have conditions or health concerns that may
hinder normal bone healing/fusion; these can include smoking, bone depleting
medications, osteoporosis, multi-level fusions, revision surgery, etc.
ligamentous spinal trauma: typically occurring in the cervical spine;
generally brought about by extreme forces causing sudden forward or
backward bending of the spine (e.g., whiplash)
metastatic cancer: type of cancer that spreads (i.e., metastasizes) from its
original site to another area of the body
MRI: Magnetic Resonance maging; procedure that uses a magnet connected
to a computer to create images of internal structures of the body

2
noninvasive: does not require placing an instrument or device through the
skin or body orifice to get treatment
nonunion fracture: failure of the pieces of a broken bone to bond together
osseous: having to do with bone, consisting of bone, or resembling bone
osteoporosis: progressive disease that causes thinning of the bones with
a decrease in bone mass
pacemaker: surgically implanted electronic device used to stimulate or
regulate contractions of the heart muscle
Paget’s disease: a chronic bone disorder that typically results in enlarged,
deformed bones
PEMF: Pulsed ElectroMagnetic Field; a time-varying (pulsing) magnetic field;
an external coil that produces a magnetic field through which an electrical
charge is given
postoperative: following an operation
prospective randomized controlled clinical study: a forward-looking
study involving human beings in which half of the patients are, at random,
given a treatment and half are not
renal disease: permanent loss of most of the kidneys’ ability to remove
waste and maintain fluid and chemical balance in the body
rheumatoid arthritis: a chronic disease resulting in stiffness and
inflammation of the joints, loss of mobility, weakness and deformity
spondylitis: inflammatory disease of the spine; inflammation of one or more
vertebrae of the spine

3
Prescription Information
Indication
The Cervical-Stim®is a noninvasive, pulsed electromagnetic bone growth
stimulator indicated as an adjunct to cervical fusion surgery in patients at
high-risk for non-fusion.
Contraindications
There are no known contraindications for the Cervical-Stim as an adjunct
to cervical spine fusion surgery.
Warnings
• Do not use Cervical-Stim if you have a cardiac pacemaker or defibrillator
because it may interfere with the operation of your pacemaker or
defibrillator. f you use the Cervical-Stim and it affects your pacemaker
or defibrillator, it may injure your heart. Consult your cardiologist.
• Remove the Cervical-Stim prior to any imaging procedures (e.g., CT scan,
MR , etc.). f you wear the Cervical-Stim during these procedures, you
could be injured, the imaging being produced may be ruined, and/or the
Cervical-Stim could be damaged.
Precautions
• Avoid using the Cervical-Stim if you do not understand the instructions your
doctor has given you. f you use the Cervical-Stim incorrectly, it may harm
you or may not help your healing process.
• The Cervical-Stim has not been evaluated in treating patients with the
following conditions: osseous or ligamentous spinal trauma, spondylitis,
Paget’s disease, moderate to severe osteoporosis, metastatic cancer, renal
disease, rheumatoid arthritis, uncontrolled diabetes mellitus, patients prone
to vascular migraine headache, seizure, epilepsy, thyroid conditions or
neurological diseases.
• Animal reproductive studies performed with this device did not show any
harmful effects in animals. However, the safety of this device for use on
patients who are pregnant or nursing has not been established.
Adverse Effects
Adverse effects may be experienced when using the Cervical-Stim. These
adverse effects may include: increased pain, numbness and tingling, headache,
migraines and nausea. These effects may or may not be directly related to
use of the Cervical-Stim. Any adverse effects that are related to the
Cervical-Stim should stop when you discontinue use. The following table
shows all adverse events that were reported during the clinical study.

4
Adverse Events Reported at 6 Months by Treatment Group
ncreased Neck Pain
Shoulder/Arm Pain
Re- njury to Cervical Spine
Adjacent level pathology
Surgical Complications
LBP/Lumbar pathology
Trauma/ njury(not cervical)
Numbness/Tingling
Headache/Migraine
Nonspecific/Unrelated Pain
Nausea
Dizziness/Vertigo
Rash/Discoloration
Rapid/ rregular Heartbeat
Shortness of Breath
Ringing in Ears
Neurologic Symptom/Stroke
Lump in Throat
Diagnosis of Diabetes
Diagnosis of Breast Cancer
Seizure
Death, Unrelated
Tenderness
Screw Broken
Graft Collapse
Carpal Tunnel Syndrome
Choking Sensation
Cardiac Symptoms
Nephrotic Syndrome
Suicide Attempt
TOTAL
Adverse Events # (%) of
Events
10 (14.9)
10(14.9)
10(14.9)
3(4.5)
2(3.0)
8(11.9)
2(3.0)
6(8.9)
2(3.0)
2(3.0)
0
2(3.0)
0
0
0
0
1(1.5)
0
0
0
0
0
1(1.5)
1(1.5)
1(1.5)
2(3.0)
1(1.5)
1(1.5)
1(1.5)
1(1.5)
67
# (%) 1of
Patients
Experiencing
the Event
9(5.6)
9(5.6)
8(5,0)
3(1.9)
2(1.3)
8(5.0)
2(1.3)
6(3.8)
2(1.3)
2(1.3)
0
2(1.3)
0
0
0
0
1(0.6)
0
0
0
0
0
1(0.6)
1(0.6)
1(0.6)
2(1.3)
1(0.6)
1(0.6)
1(0.6)
1(0.6)
472
#*(%) of
Events
16(17.8)
16(17.8)
9(10.0)
8(8.8)
7(7.7)
5(5.5)
5(5.5)
4(4.4)
4(4.4)
3(3.3)
2(2.2)
1(1.1)
1(1.1)
1(1.1)
1(1.1)
1(1.1)
1(1.1)
1(1.1)
1(1.1)
1(1.1)
1(1.1)
1(1.1)
0
0
0
0
0
0
0
0
90
# (%) 1of
Patients
Experiencing
the Event
15(9.2)
16(9.8)
9(5.5)
8(4.9)
5(3.1)
5(3.1)
4(2.5)
4(2.5)
4(2.5)
3(1.8)
2(1.2)
1(0.6)
1(0.6)
1(0.6)
1(0.6)
1(0.6)
1(0.6)
1(0.6)
1(0.6)
1(0.6)
1(0.6)
1(0.6)
0
0
0
0
0
0
0
0
582
Control Group (n=160) Cervical- tim Group (n=163)
Adverse Events
1% expressed as number of patients experiencing the event / total number of patients in the group
2Some patients experienced multiple adverse events
*There were several adverse events that were more frequently observed in the Cervical-Stim group than in the
control group. Given the types of events, it is unlikely that these adverse events are related to the treatment.
For more information regarding safety, refer to the section entitled
“Clinical Data Summary.”

5
Device Description
The Cervical-Stim Cervical Fusion System is an external, low-level, pulsed
electromagnetic field device intended to be worn after your cervical fusion
surgery to increase your chances of a successful fusion. The Cervical-Stim has
been designed with your comfort and convenience in mind. t is a single-piece
device that is lightweight, flexible and portable. t allows you to move freely
during your treatment. A Liquid Crystal Display (LCD) and an audible alarm
give you information during your treatment such as the operational status,
treatment time remaining, battery capacity, etc. See “Visual and Audio ndicators”
for more information.
The Cervical-Stim is comprised of a control unit and a treatment transducer.
The control unit contains a computer chip that generates the electrical signal.
That signal is converted to a uniform, low-energy magnetic field by the
treatment transducer. By placing the device directly over the treatment area,
the PEMF signal is delivered directly to your fusion site.
The Cervical-Stim is powered by a rechargeable lithium-ion battery pack.
The LCD and audible alarm will alert the patient when the battery is low
and needs to be recharged. See “Charging/Recharging the Battery” for more
information.
To ensure that the device is functioning properly, the Cervical-Stim
constantly monitors battery voltage and the electrical signal. f at any time
during treatment the device stops functioning properly, the LCD will display
an appropriate symbol or error code. See “Visual and Audio ndicators” for
more information.

6
Cervical- tim Cervical Fusion ystem - Model 2505
Device Life
The Cervical-Stim can provide you with up to 270 daily treatments of four hours
each. Your doctor will decide how long (weeks/months) your overall length of
treatment will be.
Treatment Time
The Cervical-Stim should be worn for four hours each day. The device will
automatically turn off when four hours of treatment is reached in a 24-hour
day. The Cervical-Stim may be used at any time of day that is convenient.
You may turn the device off at any time by simply pressing the On/Off button
on the control panel. t is lightweight and adjustable. And because the
Cervical-Stim is portable, you can get treatment while you are sitting, walking,
reclining, sleeping, etc. However, since each patient is unique, your activity
level should be based on your doctor’s instructions. Not following your
doctor’s instructions can cause injury or diminish the effect of wearing
the Cervical-Stim.
Transducer
Control Unit

7
Charging/Recharging the Battery
The Cervical-Stim is powered by a rechargeable lithium-ion battery pack.
A power supply is provided with the device. Use only the Orthofix charging
system to charge the battery.
Note: The Cervical-Stim battery will require charging prior to the first use.
To charge/recharge the battery, simply plug the barrel connector end of the
power supply into the charger port located on the control unit. Plug the line
cord securely into the power supply. Plug the line cord into any standard AC
wall outlet. A fully discharged battery may require up to 4 hours to charge
completely.
The Cervical-Stim battery can be recharged at any time the device is not in
use. t is strongly recommended that the device be recharged after completing
daily treatment.
Note: The Cervical-Stim will not deliver treatment while charging.
When the device is on, the Cervical-Stim LCD will show a battery capacity
symbol. A flashing battery outline, the symbol and an audible beep
indicate a battery low condition and that the battery requires recharging.
See “Visual and Audio ndicators” for more information.
Control Unit
Charger Port
Power Supply
Line Cord

8
Device Operation
Turning the Device On and Off
The Cervical-Stim is turned on and off by pressing the On/Off button on
the control unit of the device. When the device is on, a sequence of status
messages will display momentarily. The LCD should then show the treatment
time remaining and a flashing Orthofix logo. The flashing logo indicates that
the device is on and functioning normally. ( f you do not see this on the display,
contact your provider.) A backlight button is on the control unit. n low light,
press the backlight button for illumination of the LCD.
Timing of Treatment essions
To stop treatment prior to the end of the daily treatment session, simply press
the On/Off button. To resume treatment, press the On/Off button again.
The LCD will display the remaining treatment time.
Note: For the countdown to function correctly, treatment sessions
should be greater than 60 minutes duration.
Control Unit
On/Off Button
Backlight Button
LCD
Flashing
Orthofix Logo
Charger
Port

9
Wearing the Device
The Cervical-Stim is intended for the cervical spine and may be worn with or
without a brace. For better comfort, clothing should be worn between the
skin and the Cervical-Stim.
To use the Cervical-Stim, simply slip the device over the head so that it rests
comfortably against the neck and shoulders (see figure below). Or, the device
may be opened at the buckle and placed against the neck and shoulders.
Fasten the buckle like a seatbelt to secure the unit.
Buckle
Joint

10
Travel
When traveling by air, it is best to check the Cervical-Stim with the luggage.
f the device is taken on board the airplane, it should not be worn when
passing through passenger screening devices. The Cervical-Stim could be
damaged. The Cervical-Stim user manual should be taken with you to quickly
and easily identify the device for any security personnel.
torage
The Cervical-Stim should be stored within 14ºF to 113ºF (-10º C to 45º C)
The Cervical-Stim operating temperature range should be within 41ºF to 104ºF
(+5º C to 40º C). Relative Humidity: Up to 95%, non-condensing
Disposal
The Cervical-Stim is for single patient use. Product contains lithium
batteries; do not incinerate. Dispose of device properly to prevent
injury. Please dispose of this product at collection facilities for waste
electrical equipment used in household.
ervice
f you have questions concerning the device or require any assistance, please call
800-535-4492 or 469-742-2500. There are no user serviceable parts.
Notify the manufacturer for any servicing needs.
Care and Cleaning
The Cervical-Stim is a sophisticated electronic device and should be handled
with care. Dropping or other mistreatment of the Cervical-Stim may cause
damage to the device.
DO NOT expose the Cervical-Stim to direct sunlight
for long periods of time. The device control unit may be damaged.
DO NOT expose the Cervical-Stim to excessive heat. n warm
climates, the temperature in a car or trunk can exceed 160ºF /
71ºC. Excessive heat can damage the control unit of the device.
DO NOT expose the Cervical-Stim to excessive moisture.
Moisture can damage the electronic components of the device
and the device may stop working.
DO NOT dispose of the Cervical-Stim in an incinerator.
DO NOT use solvents to clean the Cervical-Stim.
Clean the device by wiping with a soft, damp cloth.

11
Visual and Audio Indicators
The LCD and audible alarms are designed to provide helpful information
to the user. The chart below shows the various displays and alarms and
their meaning.
Cervical- tim LCD Visual and Audio Indicators
ymbol /Alarm Description Meaning
All LCD symbols visible and
continuous audible alarm for
approximately 5 seconds
Countdown timer displays
remaining treatment time
(hours & minutes)
Orthofix logo flashes
Countdown timer
displays three dashes
audible alarm (5 beeps)
Steady symbol
for approximately 5 seconds
Symbols flash / audible alarm
(approximately 1 beep
per second)
Steady symbol indicates
approximate % of charge
Symbol filling repeatedly
indicates charge mode
Continuous audible alarm
Display of any E code
(e.g., E01, E02 . . .)
Power-on self test
Normal treatment
in progress
No treatment time
remaining
Treatment complete —
power off
Battery low —
recharge required
Battery status —
remaining charge
or charging mode
Device locked —
call for service
Error message —
call for service

12
The use of accessories other than those specified may result in increased
emissions or decreased immunity of the device.
The battery charger is provided with a 3-wire appliance inlet but considered
double insulated with Class construction throughout.
For safe usage, follow manufacturer instructions when using the product.
Use of the product in any other manner could have harmful effects and/or void
the warranty.
Note: nspect the device prior to each use for wear or deterioration.
Do not use if the device does not appear to be in suitable condition.
Equipment Classification and Device ymbol Descriptions
Equipment Classifications
• nternally powered equipment
• Type BF applied part
• EC 529 enclosure rating: PXO
• Equipment not suitable for use in the presence of a flammable anaesthetic
mixture with air or nitrous oxide
• Mode of operation: intermittent operation
ymbol Meaning
Attention - Refer to nstructions for Use
Type BF Applied Part
On/Off
Backlight Button
Storage Temperature Range
Year of Manufacture for Active Device
Charger Port

13
Clinical Data ummary
The Cervical-Stim was studied in humans to evaluate its safety and effectiveness
as a therapy added to routine care (adjunct therapy) for high-risk patients having
a cervical fusion surgery for degenerative conditions. Patients were high-risk if
they were a smoker (one pack per day or more) and/or had a multi-level fusion
surgery (more than one level).
The 323 patients were randomly assigned, similar to a coin toss, to one of two
groups: either the control group (routine care only) or the treatment group
(Cervical-Stim + routine care). One hundred and sixty (160) patients were
assigned to the control group and 163 patients were assigned to the
Cervical-Stim group. Patients wore the Cervical-Stim unit for 4 hours each day
either for 4 continuous hours or in one hour sessions.
Safety and effectiveness was evaluated by measuring the following:
• rate and severity of adverse events
• rate of cervical fusion by six months after surgery as determined by x-ray
Eighty-four percent (84%) of the Cervical-Stim group were fused by six months
(102/122 patients) versus only 69% of the control group (81/118 patients). This
is a 15% difference between these two groups and is statistically significant
(meaningful); p=0.0065. That is, more patients fused in the Cervical-Stim group
than in the control group.
The rate of patients who came back for their six month examinations and
x-rays was 74% for the Cervical-Stim group and 73% for the control group.
Patients who did not come back for scheduled examinations could not be
evaluated; thus their success or failure is not known. These unavailable data
could have a positive or negative effect on the overall success of this study.

One hundred and twelve (112) patients reported a total of 157 adverse
(negative) effects for both groups combined at six months after surgery.
There was no significant (meaningful) difference in the total number of adverse
events or the number of patients reporting effects in the control group and
the Cervical-Stim group nor in the numbers of patients in each group who
experienced an adverse event. The adverse effects that may be experienced
include: increased pain, numbness and tingling, headache, migraines and nausea.
These effects may or may not be directly related to the use of the Cervical-Stim.
Clinical success with regard to symptoms was evaluated by the following:
• no worsening in neurological function
• an improvement in pain
• no worsening in Neck Disability ndex
Based on the criteria above, there was no major difference between the
control group and the Cervical-Stim group in clinical success. An equal number
of patients in both groups showed an improvement in their clinical condition
after surgery, regardless of treatment.
Long-term x-ray information collected at 11 months after surgery or later
showed no meaningful difference in fusion rate between the Cervical-Stim
treatment group and the control group who received rountine care alone.
The results of this study show that the use of the Cervical-Stim is both safe
and effective in increasing the frequency of fusion by six months after surgery
in high-risk subjects having cervical fusion.
14

Warranty Information
Orthofix nc. warrants the Cervical-Stim bone growth stimulator to be free
from defects in materials and workmanship for one year from the date of
first use. Provided that all terms and conditions of this Limited Warranty are
complied with, Orthofix nc. will replace defective components.
This Limited Warranty applies to the product only under normal use and does
not cover any damage or defect caused by accident, misuse, abuse, fire, flood,
and acts of God or by any alteration, tampering, repair or attempted repair by
anyone other than Orthofix nc. This warranty only applies to the patient for
whom the product is prescribed and is not assignable or transferable.
Defective products covered by this Limited Warranty must be returned to
Orthofix nc. Attention: Orthofix Returns. You must call a Customer Service
Representative at 1-800-535-4492 or your local distributor to obtain the
Return Authorization (RA) number and address prior to returning the product.
Except as specifically required by applicable law, the foregoing warranty is in
lieu of all other warranties, expressed or implied and Orthofix nc. specifically
disclaims any and all warranties of merchantability or fitness for a particular
purpose. Under no circumstances shall Orthofix nc., its authorized
representative, affiliated or subsidiary companies be liable for special,
consequential or incidental damages. The sole remedy with respect to any
defective product shall be limited to replacement.
This Limited Warranty may not be extended or modified except in writing
by Orthofix nc. No sales person, representative, distributor or doctor is
authorized to make or consent to any extension or modification of the terms
of this Limited Warranty.
For additional information and/or device assistance, contact Orthofix Customer
Service at 800-535-4492.
15
Orthofix nc.
U.S.A. Edition - Patient
P/N 571356-0001 Rev D 10/2009
Printed in U.S.A.
Date of Printing: 10/2009
CS-0906 PL-US © Orthofix nc.

Sistema de fusión cervical
ED C ÓN PARA LOS EE.UU.
M A N U A L D E L PA C I E N T E