Orthofix OFIX-5000-001 User Manual

INSTRUCTION MANUAL

Model 5212

USA
SPINAL-STIM
MANUAL
SS-1602

DRAFT 5/02/16 - DO NOT DISTRIBUT

FINAL WILL BE PROVIDED ONCE APPROVED

E

Assembled in the United States of America

Spinal-Stim Device Patent No.
U.S. 5,743,844
U.S. 6,132,362
U.S. 6,261,221

Spinal-Stim® Instruction Manual
Table of Contents

Prescription Information .............................................................................

• Indications ............................................................................................

• Contraindication ...................................................................................

• Warnings ..............................................................................................

• Precautions ...........................................................................................

• Adverse Events .....................................................................................

Device Information ......................................................................................

• Device Description ................................................................................

• 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 ...........................................................................

Compliance Statements ............................................................................

Warranty ...................................................................................................

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Device Box Components

1 – Spinal-Stim
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.

Prescription Information

Indications

Spinal-Stim® 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

Spinal-Stim stimulator 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.

Front
Treatment
Coil

LCD

2:00

Back Treatment Coil

Control

Unit

Model 5212

Spinal-Stim contains a Control Unit and Treatment Coils in one integrated
device. A micro-processor generates Spinal-Stim’s electrical signal, which is a
highly uniform, low-energy magnetic field sent from the treatment coils. When
the coils are centered over the treatment area, the therapeutic Spinal-Stim 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

Spinal-Stim 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.

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Device Operation

2:00

Turning the Device On and Off

Spinal-Stim can be turned on by pressing and holding the On/Off
Button on the Control Unit of the device until it beeps.

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 semicolon on the LCD screen and On/Off button indicate that
the device is on and delivering treatment.

Spinal-Stim 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.

Treatment Indicator

Control Unit

On/Off Button

Charging

Port

LCD

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Treatment Instructions

• Spinal-Stim should be worn each day for the number of hours
prescribed by a physician (a minimum of 2 hours/day).

• Spinal-Stim may be used at any time of day that is most convenient for
the patient.

• The device is programmed to reset the treatment clock daily at midnight
Central Standard Time, unless adjusted by a physician or Orthofix
representative for a different time zone.

• Hours worn prior to the reset time will be logged and stored in the device
for monitoring daily use compliance.

• The overall treatment duration (number of months/weeks) will vary based
on specific patient conditions as determined by a physician.

• Because Spinal-Stim 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

• Spinal-Stim 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 treatment time.

• When daily treatment is completed, the device will automatically
turn off.

Charging the Battery

Spinal-Stim is powered by a rechargeable lithium-ion battery pack. 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).

To ensure that the device is functioning properly, Spinal-Stim 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.

Spinal-Stim should be charged before the first use and every day after
completing treatment. 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.

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.

3

Power

Supply

AC Wall Outlet

4

Charging

Connector

2

5

Charging Port

1

Cover

Control Unit