Orthofix CERVICAL STIM 5505CE User manual

Model 5505CE Instruction Manual

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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CervicalStim™Instruction Manual
Table of Contents
Prescription Information ...........................................................................
• Indication ...........................................................................................
• Contraindication ................................................................................
• Warnings............................................................................................
• Precautions.........................................................................................
• Adverse Effects Summary ...................................................................
Device Information ...................................................................................
• Device Description..............................................................................
• How CervicalStim 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 Classifications .......................................................................
Compliance Statements ............................................................................
Warranty ...................................................................................................
Device Box Components
1 – CervicalStim
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
CervicalStim 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 CervicalStim as an adjunct to
cervical spine fusion surgery.
Warnings
• Do not use CervicalStim if you have a cardiac pacemaker or defibrillator
because it may interfere with the operation of your pacemaker or
defibrillator. If you use CervicalStim and it affects your pacemaker or
defibrillator, it may injure your heart. Consult your cardiologist before
using CervicalStim.
• Remove CervicalStim prior to any imaging procedures (e.g., CT scan,
MRI, etc.). If you wear CervicalStim during these procedures, you could
be injured, the imaging being produced may be ruined, and/or the
CervicalStim could be damaged.
Precautions
• Avoid using CervicalStim if you do not understand the instructions your
doctor has given you. If you use CervicalStim incorrectly, it may harm you
or may not help your healing process.
• CervicalStim 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 CervicalStim. 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 CervicalStim. Any adverse effects that are related to CervicalStim should
stop when you discontinue use.
See the Adverse Events Table for a list of all adverse events reported during
the clinical study.

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Device Information
Device Description
CervicalStim 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 CervicalStim 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.
CervicalStim contains a Control Unit and a Treatment Coil in one integrated
device. A micro-processor generates CervicalStim’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.bonestimulation.com.
Device Life
CervicalStim 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.
Treatment
Coil
Control
Unit
LCD
Model 5505CE

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Control Unit
On/Off
Button
LCD
Charging
Port
Treatment Indicator
Device Operation
Turning the Device On and Off
CervicalStim 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.
CervicalStim 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.

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Treatment Instructions
• CervicalStim should be worn for 4 hours each day as prescribed by
a physician.
• CervicalStim 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 CervicalStim 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
• CervicalStim 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
CervicalStim 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 or 20114794).
To ensure that the device is functioning properly, CervicalStim 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.
CervicalStim 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 CervicalStim where it will be difficult to unplug.
4. The LED on the power supply will light up green as an indicator that the
AC Wall Outlet is delivering power.
5. 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.
6. If the battery is fully depleted, it may require up to 4 hours to charge
completely.
7. After charging is complete, remove the Charging Connector and replace
the Charging Port Cover.
AC Wall
Outlet
Control
Unit
Charging Port Cover
Charging
Connector
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4
Power Supply

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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
800-535-4492
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

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Wearing the Device
CervicalStim 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 CervicalStim:
1. To put on CervicalStim, 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.
4:00
Velcro
Tabs
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