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.
1
1
1
1
1
1
2
2
2
2
3
3
4
4
4
6
7
9
11
11
11
12
12
13
13
14
14
14
15
16
17
17
19

1
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.

2
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

3
Device Operation
Turning the Device On and Off
SpinalStim 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 colon on the LCD screen and On/Off button indicate that the
device is on and delivering treatment.
SpinalStim 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.
2:00
Control Unit
On/Off Button
Treatment Indicator
LCD
Charging
Port

4
Treatment Instructions
• SpinalStim should be worn each day for the number of hours
prescribed by a physician (a minimum of 2 hours/day).
• SpinalStim 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 SpinalStim 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.
Charging the Battery
SpinalStim 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, SpinalStim 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.
SpinalStim should be charged before the first use and every day after
completing treatment. The device will not deliver treatment while charging.
Timing of Treatment Sessions
• SpinalStim 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.

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 SpinalStim 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.
5
3
AC Wall Outlet
4
Power
Supply
1
2
Charging Port
Cover
Charging
Connector Control Unit

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.
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
Device Expired
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.
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 – Display of a closed lock indicates the
device has been available for treatment for 365 days
and will no longer provide treatment.
Compliance Screen
170/185 = 91.9%
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.
Treatment Complete
Charging Screen
Battery Charging – Battery symbol filling repeatedly
verifies that the device is charging.
Daily Prescribed Treatment complete
1:59
u
u
u
u
u
u
u
u
uLow Battery – Displays along with three fast beeps
when recharging is recommended.
Low Battery Warning Screen

7
Wearing the Device
SpinalStim can be worn over bracing and clothing. Proper treatment does not
require direct contact with the body. However, the coils must be centered
around the fusion site to be effective. Users can gently bend and shape the
treatment coils to fit more comfortably around the body.
2:00

8
2:00
1. Rest the Back Coil of the device
against the back of a chair and
the Front Coil against the left arm
of the chair. Let the Velcro®Strap
hang over the right arm of the chair.
4. Locate the Velcro Strap and pull
it snugly across your body and
attach it to the Velcro Panel
on the Front Coil.
2. Sit in the chair.
3. Pull the Front Coil toward you and
let it rest on top of your legs.
2:00
The following is the suggested method for
wearing SpinalStim:

2:00
3. To adjust the Back Coil, open the Strap Lock.
9
Sizing the Device
For minor size adjustments, adjust the placement of the
front Velcro Strap. For further adjustments, follow the
steps below.
1. Place SpinalStim around the body to determine how
much adjustment is needed.
• Note: when properly adjusted, the coils should be
centered on the body. The Control Unit should be
in front, LCD facing up.
2. If a significant size adjustment is needed, lay the unit flat with
the outside of the device Velcro Panel facing up.
Control Unit
Velcro Panel
Front Coil
Strap Lock
Strap Lock
Side Clip
Velcro Strap
Back Coil
Back Coil
Back Clip
2:00

10
5. If less strap length is needed to
make the device smaller, push the
desired amount of strap through
the Strap Lock. Slide the Back Clip
away from the Strap Lock to
tighten the excess strap.
6. Close the Strap Lock.
7. On the back coil, adjust the
Velcro Strap by pulling more or
less elastic strap through the
Side Clip.
8. When properly adjusted, the SpinalStim
straps will be approximately the same
length on each side.
4. If more strap length is needed to make the device bigger, slide the Back Clip
toward the Strap Lock. Pull the excess strap through the Strap Lock.
2:00

11
Device Accessories
Certain body types may benefit from the use of suspenders with SpinalStim.
Please contact Patient Services at 800-535-4492 or 214-937-2718 to
order suspenders.
Device Use and Care
• SpinalStim is for a single patient use.
• SpinalStim is a technologically advanced electronic device and should be
handled with care. Dropping or other mishandling of SpinalStim may damage
the device and it may stop working.
• For safe usage, follow manufacturer instructions when using SpinalStim.
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 or deterioration.
• 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 may make it unsafe to use.
Do not attempt to open or disassemble SpinalStim 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 SpinalStim 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 SpinalStim.
• DO NOT expose SpinalStim to excessive moisture.
• DO NOT use solvents or alcohol-based liquids (anti-bacterial
cleaners, hand sanitizers, perfume, etc.) to clean SpinalStim.

12
Storage
When moving the SpinalStim 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
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
SpinalStim is designed for a storage life of twelve months plus one year
of usage.
• DO NOT expose SpinalStim to direct sunlight for long periods of time.
• DO NOT expose SpinalStim to excessive heat or cold.
• Avoid storing the device in areas prone to extreme temperatures, such as
an enclosed automobile or trunk.
Travel
When traveling by air, it is recommended to pack SpinalStim 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
SpinalStim instruction manual should be taken with you to quickly and easily
identify the device for security personnel. Do not wear or operate SpinalStim
while onboard the airplane.

13
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.
SpinalStim is a 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 SpinalStim 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.

14
Clinical Information
Adjunct Clinical Trial
SpinalStim has been tested in a clinical study involving 54 surgeons at 31
centers. This clinical investigation contained a prospective randomized
double-masked trial of PEMF efficacy. SpinalStim was tested as a surgical
adjunct in patients undergoing a first attempt at lumbar fusion. At one year
postoperative, patients using active devices on a consistent daily regimen (an
average of at least two hours per day) developed solid fusion in 92.2% of
the cases.1Patients consistently using placebo (inactive) devices developed
solid fusion in 67.9% of the cases. This 35% increase in treatment effect is
statistically significant, and is realized regardless of:
• Number of levels • Vertebral level
• Graft type • Smoking
• Internal fixation • Age
• Gender
100
80
60
40
20
0
92%
68%
% Patients Fused
Active Placebo
Adjunct Clinical Trial: Overall Success Rate
The success rate for patients in the randomized double-masked phase for
whom success or failure status is known at four years after treatment with the
SpinalStim for all subjects (consistent and inconsistent users combined) was
63% (n=88) as compared with 83% in this phase of the clinical trial (i.e., one
year postoperative).

15
Consistent users (n=64) of the device in this phase had an initial success
rate of 92.2% with a success rate of 70% after four years (a 24% reduction).
Inconsistent users (n=34) and the entire placebo group (n=97) had an
initial success rate of 65% with a success rate of 50% after four years (again,
a 24% reduction). Long-term follow-up data indicates the success rate
differentials between active and placebo units are maintained over time.
Long-term, consistent SpinalStim users benefit with a 40% increase in fusion
success, when compared to inconsistent and placebo device users. Based
on this analysis, the reduction in long-term success rates appears unrelated
to treatment with the SpinalStim. During this four year period, 10% of the
original patients in the randomized double-masked phase were lost to
follow-up and are not reflected in these success rates.
Failed Fusion Clinical Trial
SpinalStim was also tested for nonoperative salvage in patients presenting
with established pseudarthrosis of lumbar fusion in an open trial. Without
concomitant regrafting, 67% of these cases reached a successful fusion with
consistent (an average of at least 2 hours per day)
PEMF treatment.2
The four year success rates for these patients in the open trial, non-operative
salvage phase for all subjects (consistent and inconsistent users combined)
was 39% (n=119) as compared with 57% in this phase of the original clinical
trial (i.e., one year postoperative). Consistent users (n=93) of the device in this
phase had a success rate of 44% after four years. Inconsistent users (n=26) of
the device in this phase had a success rate of 19% after four years.
The reduction in success rates from the time of commercial marketing
compared with those at four years showed a similar percentage decrease
(31%) to those in the randomized double-masked trial. During this four year
period, 6% of the original patients in the open phase were lost to follow-up
and are not reflected in these success rates.
1Mooney, V., “A Randomized Double-Blind Prospective Study of the Efficacy of Pulsed Electromagnetic
Field for Interbody Lumbar Fusions”, SPINE, Vol. 15, No. 7, P708, 1990.
2Simmons, JW, Hayes, MA, Christensen, KD, Dwyer, AP, Koulisis, CW, Kimmich, SJ: “The Effect of
Postoperative Pulsed Electromagnetic Fields on Lumbar Fusion: Open Trial Study”. Presented at the
Annual Meeting of the North American Spine Society, Quebec City, Canada, 2 July 1989.

16
Equipment Classification
Device Symbol Descriptions
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
10%
100%
Read Instructions for Use
REF
SN
1060
500

17
Compliance Statements
Hereby, Orthofix declares that SpinalStim Model 5212CE is in compliance with
Directive 2014/53/EU.
The full text of the EU declaration of conformity is available at the following internet
address: www.Orthofix.com
IMPORTANT! Changes or modifications not expressly approved by Orthofix, Inc.
could void the user’s authority to operate the equipment.
SpinalStim 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 > 12.5mm and dripping liquids when tilted 15° from normal
use. It is recommended you keep the unit dry.
• Shelf life for equipment: 1 year
• Mode of operation: intermittent operation
• This device is non-sterile. It does not require sterilization.
• 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