Orthofix SPINAL STIM 5212CE User manual

Model 5212CE Instruction Manual

SpinalStim Device Patent No.
U.S. 5,743,844
U.S. 6,132,362
U.S. 6,261,221
Assembled in the United States of America

SpinalStim™Instruction Manual
Table of Contents
Prescription Information .............................................................................
• Indications............................................................................................
• Contraindication...................................................................................
• Warnings..............................................................................................
• Precautions...........................................................................................
• Adverse Effects.....................................................................................
Device Information......................................................................................
• Device Description................................................................................
• How SpinalStim 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 ..............................................................................
• Sizing the Device ..................................................................................
Device Accessories.....................................................................................
Device Use and Care .................................................................................
• Care and Cleaning ..............................................................................
• Storage...............................................................................................
• Travel..................................................................................................
• Disposal..............................................................................................
• Service ................................................................................................
Clinical Information...................................................................................
• Clinical Data Summary .......................................................................
• Adjunct Clinical Trial...........................................................................
• Failed Fusion Clinical Trial...................................................................
Equipment Classification...........................................................................
SpinalStim Classifications..........................................................................
Compliance Statements ............................................................................
Warranty ...................................................................................................
Device Box Components
1 – SpinalStim
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
Indications
SpinalStim is a noninvasive electromagnetic bone growth stimulator indicated
as a spinal fusion adjunct to increase the probability of fusion success and as a
nonoperative treatment of salvage of failed spinal fusion, where a minimum of
nine months has elapsed since the last surgery.
Contraindication
Cardiac pacemakers may be adversely affected by exposure to PEMF. Use of
this device is contraindicated where the individual has an implanted cardiac
pacemaker.
Warnings
• Although animal teratological studies performed with the device
demonstrated no adverse findings, the safety of use of this device
during pregnancy and nursing in humans has not been established.
• The safety and effectiveness of the use of this device on individuals
lacking skeletal maturity have not been established.
• Animal studies conducted to date do not suggest any long-term adverse
effects from the use of a similar device. However, long-term effects in
humans are unknown.
Precautions
• This device should not be used if there are mental or physical conditions
which preclude compliance with the physician and device instructions.
• This 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, and uncontrolled diabetes mellitus.
• The results of premarketing data from the randomized double-masked
cohort indicate that inconsistent users (defined as those patients that
used the device for less than an average of two hours per day) had
success rates similar to those in the placebo group. Therefore, the use of
the device for less than the minimum recommended usage may result in
lower success rates.
Adverse Effects
Rare instances of reversible minor discomfort have been reported. These
were: cumbersome or uncomfortable, minor tingling or pain, minor skin rash,
insomnia, fainting, nausea/diarrhea, and polymenorrhea.

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Device Information
Device Description
SpinalStim is an external device that generates a Pulsed Electromagnetic Field
(PEMF) 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.
Back Treatment Coil
Front
Treatment
Coil
LCD
Control
Unit
2:00
How SpinalStim 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.
SpinalStim contains a Control Unit and Treatment Coils in one integrated device.
A micro-processor generates SpinalStim’s electrical signal, which is a highly
uniform, low-energy electromagnetic field sent from the treatment coils. When
the coils are centered over the treatment area, the therapeutic SpinalStim 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
SpinalStim 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 5212CE