Orthofix Cervical-Stim 5505 Instruction Manual
Model 5505 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
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 Accessories ....................................................................................
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.
1
1
1
1
1
1
2
2
2
2
3
3
4
4
4
6
7
7
8
8
8
9
9
9
10
10
12
13
14
14
16
1
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 highrisk 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.
2
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 5505
Treatment
Coil
Control
Unit
LCD
3
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
4
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.
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
6
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
7
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.
Device Accessories
An accessory available to the patient is a user friendly mobile application which
allows the patient to easily monitor their device use. This may be downloaded to
the patient’s smartphone.
For additional comfort, a Comfort Collar is available as an accessory. Please contact
Patient Services at 800-535-4492 or 214-937-2718 to order.
Velcro
Tabs
1
2
3
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
8
9
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 III 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 (U.S. only) or 214-937-2718. There are no user serviceable
parts. Notify Orthofix for any servicing needs.
Loading...