Orthofix Spinal-Stim User manual

INSTRUCTION MANUAL
U.S.A. EDITION

Table of Contents
Spinal-Stim®
Instruction Manual
Prescription nformation ................................................................................1
Orthofix PEMF Stimulation ............................................................................2
Clinical Success of the Spinal-Stim .................................................................2
Device Description .......................................................................................3
Treatment nstruction ...................................................................................4
Device Operation .........................................................................................4
Turning the Device On and Off ................................................................4
Timing of Treatment Sessions ...................................................................5
Charging/Recharging the Battery ..............................................................5
Visual and Audio ndicators ...........................................................................6
Device Application ........................................................................................7
Daily Application ...........................................................................................9
Clinical Data Summary ................................................................................11
Equipment Classification and Device Symbol Descriptions ...........................12
Care and Cleaning ......................................................................................13
Travel .........................................................................................................13
Storage .......................................................................................................13
Disposal ......................................................................................................13
Service .......................................................................................................13
Warranty Policy ...........................................................................................14
Package Contents:
1- Spinal-Stim Bone Growth Stimulator
1- Literature Pack
1- Power Supply
1- Line Cord
TH S DEV CE S NONSTER LE.
T DOES NOT REQU RE STER L ZAT ON.
U.S. Patent No. 5,743,844

1
Prescription Information
Indication
The 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.
arnings
• 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 Events
Rare instances of reversible minor discomfort have been reported.
They were: cumbersome or uncomfortable, minor tingling or pain,
minor skin rash, insomnia, fainting, nausea/diarrhea, and polymenorrhea.

2
Orthofix PEMF Stimulation
Pulsed electromagnetic field (PEMF) bone growth stimulation is a safe,
nonsurgical, prescription treatment to promote spinal fusion and heal nonunion
fractures. Electrical currents have been used to heal bones since the mid-1800s.
However, it wasn't until the 1950s that scientists made an important discovery.
When human bone is bent or broken, it generates an electrical field. This
low-level electrical field activates the body's own repair mechanism which,
in turn, stimulates bone healing.
Orthofix PEMF bone growth stimulators generate a uniform, low-level, pulsed
electromagnetic field similar to the electrical field generated by the body. The
application of PEMF directly to the fusion site helps activate and augment the
body's natural healing process to enhance bone fusion. Thank you for including
Orthofix in your healing process. To learn more about bone growth stimulation,
please visit our website at www.spinestimulation.com.
Clinical Success of the Spinal-Stim
The Spinal-Stim has been proven safe and effective in clinical studies.
A randomized, placebo-controlled clinical study demonstrated a 92% success
rate (fusion rate) with the adjunctive use of Spinal-Stim. An open clinical trial
of patients who were diagnosed with failed spinal fusions (nonoperative
salvage) demonstrated that application of Spinal-Stim resulted in a 67%
success rate, meaning 67% of the patient population in this study healed without
further surgery. For additional information, see the “Clinical Data” section.

3
Device Description
The Spinal-Stim Bone Growth Stimulator is an external, low-level, PEMF device
and has been designed with patient comfort and convenience in mind. t is a
single-piece device that is lightweight, flexible and portable, allowing freedom
of movement during treatment. A Liquid Crystal Display (LCD) and audible
alarm provide important feedback during treatment such as operational status,
treatment time remaining, battery capacity, etc. See “Visual and Audio
ndicators” for more information.
The Spinal-Stim is comprised of a control unit and treatment transducer.
The control unit contains a micro-processor that generates the Spinal-Stim
electrical signal. That signal is converted to a highly uniform, low-energy
magnetic field by the treatment transducer. When the device is centered
over the treatment area, the therapeutic Spinal-Stim PEMF signal is delivered
directly to the treatment site.
The Spinal-Stim is powered by a rechargeable lithium-ion battery pack.
The LCD and audible alarm will alert the patient when the battery is low and
needs to be recharged. See “Charging/Recharging the Battery” for more
information. To ensure that the device is functioning properly, the Spinal-Stim
constantly monitors battery voltage and the electrical signal. f at any time
during treatment the device stops functioning properly, the LCD will display
an appropriate symbol or error code. See “Visual and Audio ndicators”
for more information.
Model: 2212 Control Unit
Belt Adjustment
Segment
Treatment
Transducers
Nonbuckled
Strap
Buckled
Strap

4
Treatment Instructions
The Spinal-Stim should be worn daily for a minimum of two hours per day.
Based upon clinical data, the overall treatment duration ranges between 90
and 270 days based upon specific patient conditions. At the end of the daily
treatment prescribed by the physician, the device will turn itself off. The
Spinal-Stim may be used at any time of day that is most convenient and
comfortable for the patient. t is lightweight and adjustable. And because
the Spinal-Stim is 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.
Device Operation
Turning the Device On and Off
The Spinal-Stim is turned on and off by pressing the On/Off button on the
control unit of the device. When the device is on, a sequence of status messages
will display momentarily. The LCD should then show the treatment time
remaining and a flashing Orthofix logo. The flashing logo indicates that the
device is on and functioning normally. ( f you do not see this on the display,
contact Orthofix Customer Service.) A backlight button is on the control unit.
n low light, press the backlight button for illumination of the LCD.
Control Unit
nfrared Port
Flashing
Orthofix Logo LCD
On/Off Button
Backlight Button

5
Timing of Treatment Sessions
The Spinal-Stim automatically times each treatment session. The timing begins
when the device is turned on. The LCD shows a countdown of the time
remaining in the treatment session. At the end of daily treatment, the device
will turn itself off. To stop treatment prior to the end of a treatment session,
simply press the On/Off button. To resume treatment, press the On/Off
button again. The LCD will display the remaining treatment time.
Note: For the countdown to function correctly, treatment sessions
should be greater than 60 minutes duration.
Charging/Recharging the Battery
The Spinal-Stim is powered by a rechargeable lithium-ion battery pack.
A power supply is provided with the device. Use only the Orthofix charging
system to charge the battery. Note: The Spinal-Stim battery will require
charging prior to the first use.
To charge/recharge the battery, simply plug the barrel connector end of the
power supply into the charger port located on the control unit. Plug the line
cord securely into the power supply. Plug the line cord into any standard AC
wall outlet. A fully discharged battery may require up to 4 hours to charge
completely.
The Spinal-Stim battery can be recharged at any time the device is not in use.
It is strongly recommended that the device be recharged after
completing daily treatment.
Note: The Spinal-Stim will not deliver treatment while charging.
When the device is on, the Spinal-Stim LCD will show a battery capacity
symbol. A flashing battery outline, the symbol and an audible beep
indicate a battery low condition and that the battery needs to be charged.
See “Visual and Audio ndicators” for more information.
LCD
On/Off Button
R Port
Power Supply
Line Cord Charger Port

6
Visual and Audio Indicators
The LCD and audible alarms are designed to provide helpful information
to the user. The chart below shows the various displays and alarms and
their meaning.
Spinal-Stim LCD Visual and Audio Indicators
Symbol /Alarm Description Meaning
All LCD symbols visible and
continuous audible alarm for
approximately 5 seconds
Countdown timer displays
remaining treatment time
(hours & minutes)
Orthofix logo flashes
Countdown timer
displays three dashes
audible alarm (5 beeps)
Steady symbol
for approximately 5 seconds
Symbols flash / audible alarm
(approximately 1 beep
per second)
Steady symbol indicates
approximate % of charge
Symbol filling repeatedly
indicates charge mode
Continuous audible alarm
Display of any E code
(e.g., E01, E02 . . .)
Power-on self test
Normal treatment
in progress
No treatment time
remaining
Treatment complete —
power off
Battery low —
recharge required
Battery status —
remaining charge
or charging mode
Device locked —
call for service
Error message —
call for service

Device Application
Putting on the Spinal-Stim for the First Time
Applying the Spinal-Stim for the first time is easy. And wearing the Spinal-Stim
is comfortable if applied correctly. The Spinal-Stim may be worn over clothing,
a brace or orthotic device. For first time use, follow the steps below.
Step 1:
Put the Spinal-Stim around the
body to determine whether belt
adjustment is needed. When
properly adjusted, the device
should be centered over the
treatment site, and feel comfortable
and secure. The control unit should
be in front and on top as shown.
Step 2:
f significant belt adjustment is
needed, lay the unit face down with
the control unit on the table surface.
Step 4:
Open the unit fully.
Step 5:
Open the Velcro®flap.
Step 3:
Release the latch.
7

8
Step 9:
The length of the buckled strap
and the nonbuckled strap should
be approximately the same.
f significant adjustment is needed,
repeat the steps above.
Step 6:
Pull the nonbuckled strap in or out
to the desired length.
Step 7:
Store excess belt flat as shown.
Step 10:
For small adjustments, loosen or
tighten the buckled strap. Your
Spinal-Stim is now ready for
daily application.
Step 8:
Close the Velcro®flap
and close the latch.

9
Daily Application
For daily application, clothing should be worn between the skin and the
Spinal-Stim for greater comfort. The following is one suggested method
for applying the device.
Step 2:
Hold both treatment transducers
in one hand.
Step 1:
Begin with the Spinal-Stim
unbuckled and with the control
unit in front and on top.
Example of proper
lumbar application
Step 3:
Grasp the back transducer by
reaching behind with the
opposite hand.

10
Step 4:
Fasten the buckle like a seatbelt.
Make sure that the control unit is
in front and on top.
Step 5:
Make any final adjustments
by tightening or loosening
the buckled strap.
Step 6:
The treatment transducers should be centered on the front and back of the body,
over the fusion site.

11
Clinical Data Summary
Spinal-Stim 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. Spinal-Stim 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.1
Patients 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 •Gender •Smoking
•Graft Type •Vertebral Level •Age
•nternal Fixation
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
Spinal-Stim 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). 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). nconsistent 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 Spinal-Stim 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 Spinal-Stim. 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.
Spinal-Stim 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. nconsistent 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

12
The use of accessories other than those specified may result in increased
emissions or decreased immunity of the device.
The battery charger is provided with a 3-wire appliance inlet but considered
double insulated with Class construction throughout.
For safe usage, follow manufacturer instructions when using the product.
Use of the product in any other manner could have harmful effects and/or
void the warranty.
Note: nspect the device prior to each use for wear or deterioration.
Do not use if the device does not appear to be in suitable condition.
Equipment Classification and Device Symbol Descriptions
Equipment Classifications
• nternally powered equipment
• Type BF applied part
• EC 529 enclosure rating: PXO
• Equipment not suitable for use in the presence of a flammable anaesthetic
mixture with air or nitrous oxide.
• Mode of operation: intermittent operation
Symbol Meaning
Attention - Refer to nstructions for Use
Type BF Applied Part
On/Off
Backlight Button
Storage Temperature Range
Year of Manufacture for Active Device
Charger Port
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.
1. Mooney, V., "A Randomized Double-Blind Prospective Study of the Efficacy of Pulsed Electromagnetic Field for
nterbody Lumbar Fusions", SP NE, Vol. 15, No. 7, P708, 1990.
2. Simmons, 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.

Care and Cleaning
Spinal-Stim is a technologically advanced electronic device and should
be handled with appropriate care. Dropping or other mishandling of the
Spinal-Stim may cause damage to the device.
DO NOT expose the Spinal-Stim to direct sunlight
for long periods of time.
DO NOT expose the Spinal-Stim to excessive heat.
Avoid storing the device in areas prone to extreme temperatures
such as an enclosed automobile or trunk.
DO NOT expose the Spinal-Stim to excessive moisture.
DO NOT dispose of the Spinal-Stim in an incinerator.
DO NOT use solvents to clean the Spinal-Stim.
Clean the device by wiping with a soft, damp cloth.
Travel
When traveling by air, it is best to check the Spinal-Stim with the luggage. f
the device is taken on board the airplane, it should not be worn when passing
through passenger screening devices. The Spinal-Stim could be damaged. The
Spinal-Stim user manual should be taken with you to quickly and easily identify
the device for any security personnel.
Storage
Storage temperature range: -10ºC to 45ºC (14ºF to 113ºF)
Operating temperature range: +5º C to 40º C (41º F to 104ºF)
Relative humidity: Up to 95%, noncondensing
DisposalThe Spinal-Stim is for single patient use. Product contains lithium
batteries; do not incinerate. Dispose of device properly to prevent
injury. Please dispose of this product at collection facilities for waste
electrical equipment used in household.
Service
f you have questions concerning the device or require any assistance please
call 800-535-4492 or 214-937-2000. There are no user serviceable parts.
Notify the manufacturer for servicing needs.
13

arranty Policy
Orthofix nc. warrants the Spinal-Stim to be free from defects in materials
and workmanship for one year from the date of first use. Provided that all
terms and conditions of this Limited Warranty are complied with, Orthofix nc.
will replace defective components.
This Limited Warranty applies to the product only under normal use and does
not cover any damage or defect caused by accident, misuse, abuse, fire, flood,
and acts of God or by any alteration, tampering, repair or attempted repair by
anyone other than Orthofix nc. This warranty only applies to the patient for
whom the product is prescribed and is not assignable or transferable.
Defective products covered by this Limited Warranty must be returned to
Orthofix nc. Attention: Orthofix Returns. You must call a Customer Service
Representative at 1-800-535-4492 or your local distributor to obtain the
Return Authorization (RA) number and address prior to returning the product.
Except as specifically required by applicable law, the foregoing warranty is in
lieu of all other warranties, expressed or implied and Orthofix nc. specifically
disclaims any and all warranties of merchantability or fitness for a particular
purpose. Under no circumstances shall Orthofix nc., its authorized
representative, affiliated or subsidiary companies be liable for special,
consequential or incidental damages. The sole remedy with respect to any
defective product shall be limited to replacement.
This Limited Warranty may not be extended or modified except in writing by
Orthofix nc. No sales person, representative, distributor or physician is
authorized to make or consent to any extension or modification of the terms
of this Limited Warranty.
14

Orthofix nc.
U.S.A. Edition
P/N 571322-0002 Rev AA 3/2012
Printed in U.S.A.
Date of Printing: 3/2012
SS-1201 PL-US © Orthofix Holdings nc.
Manufactured by:
Orthofix nc.
3451 Plano Parkway
Lewisville, TX 75056-9453
Tel [phone]
Customer Service
800-535-4492 toll free
www.orthofix.com

MANUAL D E I N S T R U C C I O N E S
Estimulador del
crecimiento óseo
EDICIÓN PARA LOS EE.UU.

Índice
Manual de instrucciones de
Spinal-Stim®
nformación de prescripción ................................................................ 1
Estimulación CEMP de Orthofix ....................................................................... 2
Éxito clínico de Spinal-Stim .................................................................. 2
Descripción del dispositivo .................................................................. 3
nstrucciones de tratamiento ............................................................... 4
Funcionamiento del dispositivo ............................................................. 4
Cómo encender y apagar el dispositivo ............................................. 4
Cronometraje de las sesiones de tratamiento ..................................... 5
Cómo cargar/recargar la batería ...................................................... 5
ndicadores visuales y de audio ............................................................. 6
Aplicación del dispositivo .................................................................... 7
Aplicación diaria ................................................................................ 9
Resumen de datos clínicos ................................................................. 11
Clasificación del equipo y descripciones de los símbolos del dispositivo ...... 12
Cuidado y limpieza ........................................................................... 13
Viajes ............................................................................................ 13
Almacenamiento .............................................................................. 13
Eliminación...................................................................................... 13
Servicio técnico ................................................................................ 13
Política de garantía ........................................................................... 14
Contenido del paquete:
1- Estimulador del crecimiento óseo Spinal-Stim
1- Paquete de material impreso
1- Fuente de alimentación
1- Cable de alimentación
ESTE D SPOS T VO NO ESTÁ ESTER L ZADO.
NO REQU ERE ESTER L ZAC ÓN.
Patente de los EE. UU. n.° 5,743,844

1
Información de prescripción
Indicación
Spinal-Stim®es un estimulador del crecimiento óseo no invasivo indicado
como complemento para aumentar la probabilidad de éxito de la fusión y
como tratamiento no quirúrgico de rescate para el fracaso de la fusión espinal,
cuando ha transcurrido un mínimo de nueve meses desde la última operación.
Contraindicación
Los marcapasos cardíacos pueden verse afectados en forma adversa por la
exposición a campos electromagnéticos pulsados (CEMP). El uso de este dis-
positivo está contraindicado en personas que tengan un marcapasos cardíaco
implantado.
Advertencias
• Si bien los estudios teratológicos en animales realizados con el dispositivo
no demostraron hallazgos adversos, no se ha establecido la seguridad del
uso de este dispositivo durante el embarazo y la lactancia en humanos.
• No se ha establecido la seguridad y efectividad del uso de este dispositivo
en personas que no son esqueléticamente maduras.
• Los estudios en animales realizados hasta la fecha no sugieren la presencia
de ningún efecto adverso a largo plazo debido al uso de un dispositivo simi-
lar. No obstante, se desconocen los efectos a largo plazo en humanos.
Precauciones
• Este dispositivo no debe usarse si existen afecciones mentales o físicas que
impidan el cumplimiento de las instrucciones del médico y del dispositivo.
• Este dispositivo no ha sido evaluado en el tratamiento de pacientes con las
siguientes afecciones: traumatismo espinal óseo o ligamentoso, espondilitis,
enfermedad de Paget, osteoporosis de moderada a grave, cáncer metastási-
co, enfermedad renal y diabetes mellitus no controlada.
• Los resultados de los datos antes de la comercialización, obtenidos de la
cohorte a doble ciego aleatorizada, indican que los usuarios que no siguieron
sistemáticamente las indicaciones (definidos como aquellos pacientes que
usaron el dispositivo durante menos de un promedio de dos horas por día)
alcanzaron tasas de éxito similares a los del grupo que recibió placebo.
Por lo tanto, el uso del dispositivo durante un período menor que el mínimo
recomendado puede dar como resultado tasas de éxito más bajas.
Eventos adversos
En raras ocasiones, se han informado molestias menores reversibles. Estas
han sido: incomodidad o molestias, ligero hormigueo o dolor, leve erupción
cutánea, insomnio, desmayo, náuseas/diarrea y polimenorrea.