Orthofix Cervical-Stim User manual

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Model 5505CM Instruction Manual

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CervicalStim Device Patent No.
U.S. 6,024,691
U.S. 5,743,844
U.S. 6,132,362
Assembled in the United States of America
ASSEMBLED IN
USA

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The CervicalStim™Device Instruction Manual
Table of Contents
Prescription Information ...........................................................................
• Indication ...........................................................................................
• Contraindication ................................................................................
• Warnings............................................................................................
• Precautions.........................................................................................
• Adverse Effects Summary ...................................................................
Device Information ...................................................................................
• Device Description..............................................................................
• How the CervicalStim Device Works ...................................................
• Device Life ..........................................................................................
Device Operation .....................................................................................
• Turning the Device On and Off .........................................................
• Treatment Instructions .......................................................................
• Timing of Treatment Sessions ...........................................................
• Charging the Battery ..........................................................................
• Visual and Audio Indicators ..............................................................
• Wearing the Device ............................................................................
Device Use and Care .................................................................................
• Care and Cleaning ..............................................................................
• Storage ...............................................................................................
• Travel ..................................................................................................
• Disposal ..............................................................................................
• Service ................................................................................................
Clinical Information...................................................................................
• Clinical Data Summary .......................................................................
• Adverse Events ...................................................................................
Equipment Classification...........................................................................
CervicalStim Device Classifications ............................................................
Compliance Statements ............................................................................
Warranty ...................................................................................................
Device Box Components
1 – CervicalStim Device
1 – Power Supply
1 – Literature Pack
Orthofix Patient Services: 800-535-4492 or 214-937-2718
To learn more about Orthofix, please visit our website at www.orthofix.com.

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Prescription Information
Indication
The CervicalStim device is a noninvasive, pulsed electromagnetic bone growth
stimulator indicated as an adjunct to cervical fusion surgery in patients at
high-risk for non-fusion.
Contraindication
There are no known contraindications for the CervicalStim device as an
adjunct to cervical spine fusion surgery.
Warnings
• Do not use the CervicalStim device if you have a cardiac pacemaker
or defibrillator because it may interfere with the operation of your
pacemaker or defibrillator. If you use the CervicalStim device and it affects
your pacemaker or defibrillator, it may injure your heart. Consult your
cardiologist before using the CervicalStim device.
• Remove the CervicalStim device prior to any imaging procedures (e.g.,
CT scan, MRI, etc.). If you wear the CervicalStim device during these
procedures, you could be injured, the imaging being produced may be
ruined, and/or the CervicalStim device could be damaged.
Precautions
• Avoid using the CervicalStim device if you do not understand the
instructions your doctor has given you. If you use the CervicalStim device
incorrectly, it may harm you or may not help your healing process.
• The CervicalStim device 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 Summary
Adverse effects may be experienced when using the CervicalStim device. 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 CervicalStim device. Any adverse effects that are related to the
CervicalStim device should stop when you discontinue use.
See the Adverse Events Table for a list of all adverse events reported during
the clinical study.
Please refer to the Compliance Statements section of the manual for
compatibility information regarding implantable medical devices.

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Device Information
Device Description
The CervicalStim device is an external device that generates a Pulsed
Electromagnetic Field (PEMF) signal as a nonsurgical, prescription treatment
to increase the chances of a successful fusion. The device is lightweight,
adjustable and portable, including a rechargeable battery that allows
freedom of movement during treatment. A Liquid Crystal Display (LCD) and
audible indicators provide important feedback during treatment. See “Device
Operation” for more information.
How the CervicalStim device Works?
To enhance bone healing after a fusion surgery, PEMF therapy activates
and augments the body’s natural healing process that may be impaired in
some people.
The CervicalStim device contains a Control Unit and a Treatment Coil in one
integrated device. A micro-processor generates the CervicalStim device’s
electrical signal, which is a highly uniform, low-energy electromagnetic field
sent from the treatment coil. When the coil is centered over the treatment area,
the therapeutic CervicalStim PEMF signal is delivered through clothing and skin
directly to the fusion site.
To learn more about bone growth stimulation, please visit our patient website
at www.BoneGrowthTherapy.com.
Device Life
The CervicalStim device provides daily treatments for up to 365 days. The
physician determines the overall length of treatment (months/weeks) on an
individual basis according to fusion healing progress.
Model 5505CM
Treatment
Coil
Control
Unit
LCD

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Device Operation
Turning the Device On and Off
The CervicalStim device can be turned on by pressing the On/Off Button on
the Control Unit of the device.
When the device is turned on, a status screen will display the number
of days since the first use, the treatment status, and the
compliance percentage.
The LCD will show the prescribed treatment time remaining and the
battery status.
The flashing colon on the LCD screen and On/Off button indicate that the
device is on and delivering treatment.
The CervicalStim device can be turned off by pressing and holding the On/
Off Button on the Control Unit of the device until it beeps.
The On/Off Button on the Control Unit doubles as a Backlight to light up
the LCD. In low light, press the On/Off Button to light up the LCD.
1:59
Control Unit Charging Port
LCD Treatment Indicator On/Off Button

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Treatment Instructions
• The CervicalStim device should be worn for 4 hours each day as prescribed
by a physician.
• The CervicalStim device may be used at any time of day that is most
convenient for the patient.
• The device is programmed to reset daily at midnight Central Standard Time,
unless adjusted by a physician or Orthofix representative for a
different time zone or reset time.
• Hours worn before the reset time will be logged and stored in the device for
daily use compliance.
• The overall treatment duration (months/weeks) will vary based on
specific patient conditions as determined by a physician.
• Because the CervicalStim device is lightweight and portable, treatment can
be received while sitting, walking, reclining, sleeping, etc. However, since
each patient is unique, the overall activity level should be based on
physician instructions.
Timing of Treatment Sessions
• The CervicalStim device tracks the treatment time; this tracking (or timing)
begins when the device is turned on and at least one minute of treatment
is complete.
• The LCD shows a countdown of the daily treatment time remaining.
• To stop treatment at any point, simply press and hold the On/Off Button
until you hear a beep.
• To resume treatment, press the On/Off button again.
• The countdown will resume at the remaining daily treatment time.
• When daily treatment is completed, the device will automatically
turn off.
Charging the Battery
The CervicalStim device is powered by a rechargeable lithium-ion battery pack.
The battery pack will provide at least one full treatment before needing to be
recharged. A power supply to charge the battery is provided with the device.
Use only the Orthofix power supply to charge the battery (Part no. Orthofix
20110412, 20114794, WR9QA1200U23KIT(R6B), or 20123808).
To ensure that the device is functioning properly, the CervicalStim device
constantly monitors battery voltage and the electrical signal. The LCD will display
a battery capacity symbol and the device will beep to alert the patient when
the battery is low and will soon need to be recharged.
The CervicalStim device should be charged before the first use and every day
after completing treatment. Do not wear the device while charging. The device
will not deliver treatment while charging.

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Follow these steps to recharge the battery:
1. Open the Charging Port Cover.
2. Plug the Charging Connector into the Charging Port located on the
Control Unit.
3. Plug the power supply into any standard AC Wall Outlet. Do not plug in
the power supply for the CervicalStim device where it will be difficult to
unplug.
4. The Control Unit LCD will display a battery symbol filling to verify that
the device is charging. When the battery reaches a complete charge,
a check mark symbol will be displayed next to the battery symbol. In
addition, the device will beep once to alert the patient.
5. If the battery is fully depleted, it may require up to 4 hours to charge
completely.
6. After charging is complete, remove the Charging Connector and replace
the Charging Port Cover.
Angled Corners
AC Power Supply
AC Charging Connector
Charging Port Cover

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Visual and Audio Indicators
The LCD and audible beeps are designed to provide helpful information
to the user. The screens, symbols, and beeps are explained below.
Compliance Screen
170/185 = 91.9%
Treatment Screen
1:59 Treatment Screen – displays the treatment time remaining
in hours and minutes. The timer counts down to zero until
daily treatment is complete.
Exception Screen
E123 Exception Codes – Display of ERROR, any E codes
(e.g., E01, E02), along with three slow beeps. Contact
Patient Services at 800-535-4492 or 214-937-2718.
Low Battery Warning Screen
1:59 Low Battery – Displays along with three fast beeps when
recharging is recommended.
Charging Complete
Charging Complete – Indicates when the battery is
fully charged.
Battery must be charged
to turn on
E12345678
E12345678
Battery Empty – Indicates that the battery must be
charged before treatment may continue.
Device Expired
Device Expired – Display of a closed lock indicates the
device has been available for treatment for 365 days
and will no longer provide a treatment..
Compliance Screen – Displays a compliance percentage
which is calculated by the number of full treatments days
completed over the number of available treatment days.
The treatments days available begin once the device has
been delivered to the patient and a minute of treatment
time has been established.
Charging Screen
Battery Charging – Battery symbol filling repeatedly
verifies that the device is charging.
Treatment Complete
Daily Prescribed Treatment complete
1-800-535-4492

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Wearing the Device
The CervicalStim device may be worn over a brace, cervical collar, halo, or
clothing. Proper treatment does not require direct contact with the body.
However, the coil must be centered around the fusion site to be effective. Users
can gently bend and shape the treatment coil to fit more comfortably around
the neck.
The following is the suggested method for wearing the CervicalStim device :
1. To put on the CervicalStim device, simply slip the device over your head.
2. For a wider opening, detach the Velcro®Tab near the control unit
and place over your head.
3. The device does not need to be tight against the back of the neck;
it should rest comfortably on your shoulders.
Velcro
Tabs
1
2
3
For additional comfort, a Comfort Collar is available as an accessory for the
CervicalStim device. Please contact Patient Services at 800-535-4492 or
214-937-2718 to order.

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Device Use and Care
• The CervicalStim device is for single patient use.
• The CervicalStim device is a technologically advanced electronic device
and should be handled with care. Dropping or other mishandling of the
CervicalStim device may damage the device and it may stop working.
• For safe usage, follow manufacturer instructions when using the
CervicalStim device. You (the patient) are the intended operator of this
device.
• Use of the device in any other manner could have harmful effects and/or
void the warranty.
• The use of accessories other than those specified may result in increased
emissions or decreased immunity of the device.
• Inspect the device prior to each use for wear, deterioration or damage.
• Do not use or charge the device if it does not appear to be in suitable
condition, displays an error or stops working. Contact Patient Services if
any of these occur.
• WARNING: Do not modify this equipment as this could make it unsafe to
use. Do not attempt to open or disassemble the CervicalStim device as
there are no user serviceable parts inside.
• CAUTION: STRANGULATION HAZARD – Keep the Power Supply cord out of
the reach of children.
Care and Cleaning
When cleaning the CervicalStim device, follow these instructions:
• WARNING: Do not clean the device during treatment or charging.
• Clean the device by wiping surfaces with a damp, soft cloth
(wet with water only).
• DO NOT sterilize the CervicalStim device.
• DO NOT expose the CervicalStim device to excessive moisture.
• DO NOT use solvents or alcohol-based liquids (anti-bacterial
cleaners, hand sanitizers, perfume, etc.) to clean the CervicalStim device.
Storage
When moving the CervicalStim device from very cold or very hot storage areas
(like your car), wait at least an hour to use or charge the device. The device
requires time to return to operating temperature.
Unpacked Storage:
Temperature Range:
• -25°C to 5°C
• 5°C to 35°C at up to 90% relative humidity, non-condensing
• 35°C to 60°C at a water vapor pressure up to 50 hPa

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Packed Storage, Shipping and Transport:
Temperature Range: within -40°C to 60°C
• Between 10-100% relative humidity
• Including condensation at pressures between 500 hPa and 1060 hPa
Operating Environment:
Temperature Range: within 5°C to 40°C
• 15-90% relative humidity, non-condensing but not requiring a water
vapor pressure greater than 50 hPa
• 700-1060 hPa
The CervicalStim device is designed for a storage life of twelve months plus
one year of usage.
Travel
When traveling by air, it is recommended to pack the CervicalStim device
with checked luggage. If taken onboard the airplane, it should be turned off
when passing through security screening equipment, as the device could be
damaged. The CervicalStim device instruction manual should be taken with
you to quickly and easily identify the device for security personnel. Do not
wear or operate the CervicalStim device while onboard the airplane.
Disposal
After treatment is complete and a physician advises you to discontinue use,
you may dispose of the device according to your local governing ordinances
or recycling plans. Contact your local authorities to determine the proper
method for disposal since this is electronic equipment containing a lithium-ion
battery. You may also contact Orthofix Patient Services regarding recycling.
The CervicalStim device is for single patient use.
The CervicalStim device is a Class 2 medical device (prescription only) that
cannot be sanitized or used by another person.
Dispose of the device properly to prevent injury.
DO NOT dispose of the CervicalStim device in an incinerator. This
device contains lithium batteries.
Service
If you have questions concerning the device or require any assistance, please
call 800-535-4492 or 214-937-2718. There are no user serviceable parts.
Notify Orthofix for any servicing needs.

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Clinical Information
Clinical Data Summary
The
CervicalStim device 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, to one of two groups: either the
control group (routine care only) or the treatment group (
CervicalStim device
+ routine care). One hundred and sixty (160) patients were assigned to the
control group and 163 patients were assigned to the
CervicalStim device
group. Patients wore the
CervicalStim device 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
CervicalStim device 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
CervicalStim device group than in the control group.
Clinical Trial: Overall Success Rate
100
80
60
40
20
0
84%
69%
% Patients Fused
Treated Untreated

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The rate of patients who came back for their six month examinations and
x-rays was 74% for the CervicalStim device 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 CervicalStim device 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 CervicalStim device.
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 Index
Based on the criteria above, there was no major difference between the
control group and the CervicalStim device 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 CervicalStim
device treatment group and the control group who received routine care
alone.
The results of this study show that the use of the CervicalStim device is both
safe and effective in increasing the frequency of fusion by six months after
surgery in high-risk subjects having cervical fusion.

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Adverse Events Reported at 6 Months by Treatment Group
Control Group (n=160) CervicalStim Device Group (n=163)
Increased Neck Pain
Shoulder/Arm Pain
Re-Injury to Cervical Spine
Adjacent level pathology
Surgical Complications
LBP/Lumbar pathology
Trauma/Injury(not cervical)
Numbness/Tingling
Headache/Migraine
Nonspecific/Unrelated Pain
Nausea
Dizziness/Vertigo
Rash/Discoloration
Rapid/Irregular 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)
CervicalStim Device Group
(n=163)
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 CervicalStim device group than in
the control group. Given the types of events, it is unlikely that these adverse events are related to the treatment.

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Equipment Classification
Device Symbol Descriptions
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Symbol Meaning Symbol Location
Attention – Refer to Instruction Manual Device and Device Box
Type BF Applied Part Device and Device Box
On/Off Device
Prescription Only Device
Storage Temperature Range Device Box
Year of Manufacture for Active Device Device and Device Box
Manufacturer Instruction Manual
Not for General Waste Device and Device Box
Keep Dry Device and Device Box
FCC Mark Device and Device Box
CE Mark Device and Device Box
Storage Humidity Limits Device and Device Box
Atmospheric Pressure Limitations Device Box
EU Authorized Representative Instruction Manual
Catalog Number Device and Device Box
Serial Number Device and Device Box
Read Instructions for Use
REF
SN
RCM - Regulatory Compliance Mark
(Australia) Device

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Compliance Statements
This device complies with Industry Canada licence-exempt RSS standard(s). Operation
is subject to the following two conditions: (1) this device may not cause interference,
and (2) this device must accept any interference, including interference that may
cause undesired operation of the device.
IMPORTANT! Changes or modifications not expressly approved by Orthofix, Inc.
could void the user’s authority to operate the equipment.
CervicalStim Device Classifications
• Product Family Name: Orthofix PEMF Device
• Internally powered equipment. The service life of the non-replaceable
lithium-ion battery is 2.5 years.
• This device generates a non-ionizing pulsed electromagnetic field with an
intensity of approximately 2 Gauss and frequency components in the
1Hz-50KHz range. This field is distributed within and near the treatment coil.
• Type BF applied part. The applied part is the treatment coil with integrated
control unit.
• IEC 60529 enclosure rating: IP22. IP22 means the enclosure provides
protection from solid objects greater than 12.5 mm and dripping liquids when
tilted 15° from normal use. It is recommended you keep the unit dry.
• Mode of operation: intermittent operation
• This device is non-sterile. It does not require sterilization.
• Shelf life for equipment: 1 year
• Equipment not suitable for use in the presence of a flammable
anesthetic mixture with air or nitrous oxide.
• The power supply is considered double insulated with Class II
construction throughout.
• Power supply ratings:
Orthofix # 20110412:
Orthofix # 20114794:
Input: 100-240VAC, 50-60Hz, 200mA Input: 100-240VAC, 50-60Hz, 150-350mA
Output Voltage: 5VDC, 1.3A Output Voltage: 5VDC, 2.4A
Orthofix#: 20123808: Orthofix#: WR9QA1200U23KIT(R6B):
Input: 100-240VAC, 50-60Hz, 0.6-0.3A Input: 100-240VAC, 50-60Hz, 0.6A
Output Voltage: 5VDC, 1.2A Output Voltage: 5VDC, 1.2A

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CAN ICES-3(B)/NMB-3(B)
This equipment complies with radiation exposure limits set forth for uncontrolled
environment.
If this equipment does cause harmful interference to radio or television reception,
which can be determined by turning the equipment off and on, the user is encouraged
to try to correct the interference by one or more of the following measures:
• Reorient or relocate the receiving antenna.
• Increase the separation between the equipment and receiver.
• Connect the equipment into an outlet on a circuit different from that to which
the receiver is connected.
• Consult the dealer or an experienced radio/TV technician for help.
Information regarding Electromagnetic Compatibility and Immunity
The CervicalStim device complies with IEC 60601-1-2 for electromagnetic
compatibility (EMC).
The CervicalStim device needs special precautions regarding
EMC and needs to be used in accordance with the EMC information provided
in this manual. Wireless communications equipment such as home network
devices, mobile phones, cordless telephones and their base stations, and walkie-
talkies can affect
the CervicalStim device . These types of equipment should be
kept at least 0.198 m (7.8 in) away from
the CervicalStim device .
The CervicalStim device has not been evaluated with regard to use with specific
implantable electronic medical devices. Please consult your physician prior
to use of the CervicalStim device with implantable electronic medical devices.

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Warranty
Orthofix Inc. warrants the CervicalStim device 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 Inc.
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 Inc. 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 Inc., Attention: Orthofix Returns. You must call a Patient Services
Representative or your local distributor to obtain the Return Authorization
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 Inc. specifically
disclaims any and all warranties of merchantability or fitness for a particular
purpose. Under no circumstances shall Orthofix Inc., 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 Inc. No sales person, representative, distributor or physician 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
Patient Services at 800-535-4492 or 214-937-2718.