Orthofix Cervical-Stim 2505CE User manual

INSTRUCTION MANUAL
INTERNATIONAL
EDITION

Table of Contents
Cervical-Stim®
Instruction Manual
Device Description ...................................................................................... 1
The Orthofix Approach to Healing ............................................................... 1
P MF Stimulation ......................................................................................... 2
Prescription Information .............................................................................. 2
Clinical Data Summary ............................................................................... 3
Data Analysis & Results ............................................................................... 5
ffectiveness Results ..................................................................................... 6
Safety .......................................................................................................... 8
Device Life .................................................................................................. 8
Treatment Instructions .................................................................................. 8
Charging/Recharging the Battery ................................................................... 9
Device Operation ....................................................................................... 10
Wearing the Device .................................................................................... 11
Care and Cleaning ...................................................................................... 12
Travel ......................................................................................................... 12
Storage ...................................................................................................... 12
Disposal ...................................................................................................... 12
Visual and Audio Indicators .......................................................................... 13
quipment Classification and Device Symbol Descriptions ............................ 14
Service ....................................................................................................... 14
Conformance to Standards .......................................................................... 15
Warranty Information ................................................................................. 15
To learn more about Orthofix, please visit our website at www.orthofix.com.
Package Contents:
1- Cervical-Stim®Cervical Fusion System
1- Literature Pack
1- Charger Unit #270215
1- Comfort Collar
THIS D VIC IS NONST RIL .
IT DO S NOT R QUIR ST RILIZATION.
0086
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1
The Cervical-Stim is comprised of a control unit and a treatment transducer.
The control unit contains a micro-processor that generates the Cervical-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 Cervical-Stim P MF signal is delivered
directly to the fusion site.
The Cervical-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 Cervical-Stim
constantly monitors battery voltage and the electrical signal. If at any time
during treatment, the device stops functioning properly, the LCD will display
an appropriate symbol or error code. See “Visual and Audio Indicators”
for more information.
The rthofix Approach to Healing
Orthofix is an established worldwide leader in P MF (pulsed electromagnetic
field) bone growth stimulation technology. Orthofix developed the first
noninvasive, portable P MF stimulator for cervical fusion with the launch of the
Cervical-Stim Cervical Fusion System in 2005. Orthofix continues to refine and
improve the delivery of pulsed electromagnetic fields for the healing of cervical
spine fusion and salvage of failed cervical spine fusion. Orthofix produces a full
Device Description
The Cervical-Stim®Cervical Fusion System is an external, low-level, Pulsed
lectromagnetic Field (P MF) device and has been designed with patient comfort
and convenience in mind. It 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 information during treatment such as
operational status, treatment time remaining, battery capacity, etc. See “Visual
and Audio Indicators” for more information.
Cervical-Stim Cervical Fusion System - Model 2505CE
Transducer
Buckle
Joint
Control Unit Control Panel

2
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range of state-of-the-art medical devices for orthopaedics and neurosurgery
that enhance the body's natural healing process, simulate natural function,
protect, restore and heal. Thank you for including Orthofix in your healing
process. To learn more about Orthofix, please visit our website at
www.orthofix.com.
PEMF Stimulation
Pulsed electromagnetic field (P MF) bone growth stimulation is a safe,
nonsurgical treatment prescribed by a physician to heal nonunion fractures
and promote spinal fusion. lectrical 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 P MF bone growth stimulators generate a uniform, low-level, pulsed
electromagnetic field similar to the electrical field generated by the body.
The application of P MF directly to the fusion or fracture site helps activate
and augment the body’s natural healing process to enhance bone fusion.
Prescription Information
Indication
The Cervical-Stim is a noninvasive, pulsed electromagnetic bone growth
stimulator indicated as an adjunct to cervical fusion surgery in patients at
high-risk for non-fusion and nonoperative salvage of failed cervical spine fusion.
Contraindications
There are no known contraindications for the Cervical-Stim.
Warnings
• The Cervical-Stim may interfere with the operation of a cardiac pacemaker
or defibrillator. Consultation with the attending cardiologist is recommended.
• The Cervical-Stim should be removed prior to any imaging procedures
(e.g., CT scan, MRI, etc.).
Precautions
• The Cervical-Stim should not be used if there are mental or physical
conditions that may preclude compliance with physician or device
instructions.
• The Cervical-Stim 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 teratological studies performed with this device did not show any
adverse effects in animals. However, the safety of this device for use on
patients who are pregnant or nursing has not been established.

3
Clinical Data Summary
Study Design
The Cervical-Stim clinical study was a controlled, randomized, parallel
group study of 323 high-risk (smokers, multi-level or both and allograft) adult
subjects with radiographic evidence of compressed cervical nerve roots and
Adverse Events Reported at 6 Months by Treatment Group
Increased Neck Pain
Shoulder/Arm Pain
Re-Injury to Cervical Spine
Adjacent level pathology
Surgical Complications
LBP/Lumbar pathology
Trauma/Injury(not cervical)
Numbness/Tingling
Headache/Migraine
Nonspecific/Unrelated Pain
Nausea
Dizziness/Vertigo
Rash/Discoloration
Rapid/Irregular Heartbeat
Shortness of Breath
Ringing in ars
Neurologic Symptom/Stroke
Lump in Throat
Diagnosis of Diabetes
Diagnosis of Breast Cancer
Seizure
Death, Unrelated
Tenderness
Screw Broken
Graft Collapse
Carpal Tunnel Syndrome
Choking Sensation
Cardiac Symptoms
Nephrotic Syndrome
Suicide Attempt
TOTAL
Adverse Events # (%) of
Events
10(14.9)
10(14.9)
10(14.9)
3(4.5)
2(3.0)
8(11.9)
2(3.0)
6(8.9)
2(3.0)
2(3.0)
0
2(3.0)
0
0
0
0
1(1.5)
0
0
0
0
0
1(1.5)
1(1.5)
1(1.5)
2(3.0)
1(1.5)
1(1.5)
1(1.5)
1(1.5)
67
# (%) 1of
Patients
Experiencing
the Event
9(5.6)
9(5.6)
8(5.0)
3(1.9)
2(1.3)
8(5.0)
2(1.3)
6(3.8)
2(1.3)
2(1.3)
0
2(1.3)
0
0
0
0
1(0.6)
0
0
0
0
0
1(0.6)
1(0.6)
1(0.6)
2(1.3)
1(0.6)
1(0.6)
1(0.6)
1(0.6)
472
#*(%) of
Events
16(17.8)
16(17.8)
9(10.0)
8(8.8)
7(7.7)
5(5.5)
5(5.5)
4(4.4)
4(4.4)
3(3.3)
2(2.2)
1(1.1)
1(1.1)
1(1.1)
1(1.1)
1(1.1)
1(1.1)
1(1.1)
1(1.1)
1(1.1)
1(1.1)
1(1.1)
0
0
0
0
0
0
0
0
90
# (%) 1of
Patients
Experiencing
the Event
15(9.2)
16(9.8)
9(5.5)
8(4.9)
5(3.1)
5(3.1)
4(2.5)
4(2.5)
4(2.5)
3(1.8)
2(1.2)
1(0.6)
1(0.6)
1(0.6)
1(0.6)
1(0.6)
1(0.6)
1(0.6)
1(0.6)
1(0.6)
1(0.6)
1(0.6)
0
0
0
0
0
0
0
0
582
Control Group (n=160) Cervical-Stim Group (n=163)
Adverse Events
1. % expressed as number of patients experiencing the event / total number of patients in the group
2. Some patients experienced multiple adverse events
*There were several adverse events that were more frequently observed in the Cervical-Stim group than in the
control group. Given the types of events, it is unlikely that these adverse events are related to the treatment.

4
symptomatic radiculopathy. The purpose of the study was to evaluate the
safety and effectiveness of the P MF Cervical-Stim device as an adjunct for
high-risk patients who undergo cervical fusion. All subjects underwent
anterior cervical discectomy and fusion using the Smith-Robinson technique
with the Atlantis Plate. Subjects were randomly assigned to either the control
group (standard treatment, n=160) or the treatment group (standard treatment
plus the Cervical-Stim, n=163). Standard treatment was at the physician's
discretion but typically included the standard hospital stay, use of a soft cervical
collar, appropriate medications and physical therapy.
Subjects who met the following inclusion and exclusion criteria were eligible
for participation in the study:
Inclusion Criteria
Adult male or female,18-75 years old with radiographic evidence of
compressed cervical nerve root(s), symptomatic radiculopathy, pain of 5 or
greater on the Visual Analog Scale (VAS) and/or any muscle weakness and
primary cervical spinal fusion performed using the Smith-Robinson technique
with allograft bone and an anterior cervical plate. The fusion procedure must
have been either multi-level (>1 fusion level) or the subject was a smoker
(one pack/day or more) or both; and signed informed consent.
Exclusion Criteria
Traumatic cervical injury, posterior approach or revision fusion, autograft
or bone substitute materials for graft source, history of vascular migraine
headache or prone to uncontrolled seizures or epilepsy (controlled or
uncontrolled) or any neurological diseases or injury; depressed immune
system, regional conditions (Spondylitis, Paget’s disease, rheumatoid arthritis),
infection (systemic or local) within 2 weeks prior to surgery, systemic
conditions (cancer, cardiac arrhythmia, thyroid disease, uncontrolled diabetes
mellitus, renal disease/dysfunction, chronic steroid use or other conditions that
may have affected bone metabolism), cardiac pacemakers, defibrillators, dorsal
column stimulators, hearing aids, cochlear prostheses and cranial stimulators,
subjects who were pregnant, nursing or had planned to become pregnant
within 12 months, subjects that had participated in other clinical studies within
the last 12 months, or had mental or physical conditions which may have
precluded compliance with physician instructions.
Evaluation and Follow-Up
Follow-up visits were to have been performed at months 1, 2, 3, 6 and 12
and annually thereafter until the last subject enrolled reached 12 months.
Device Usage
Subjects assigned to the treatment group (Cervical-Stim) were instructed
to wear the device for four hours per day for a minimum of three months
postoperative. Surgeons could, at their discretion, extend the Cervical-Stim
treatment up to six months postoperative.
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1. P-values of comparison tests between treatment groups using Student’s t-test for numerical
variables and Pearson x2test for categorical variables.
Data Analysis and Results
The primary effectiveness endpoint was the increase in frequency of cervical
fusion success by six months postoperatively as assessed by radiographic
evidence. Secondary endpoints were neurological function, VAS pain assessment
and Neck Disability Index. Safety was assessed by the frequency and severity
of adverse events.
Fusion was assessed by radiographs at each visit:
Radiographic fusion was defined as > 50% bony bridging on both the
superior and inferior graft interfaces between adjacent vertebral bodies
AND < 4° angulation (motion) between adjacent fused vertebrae on
flexion/extension lateral films AND absence of radiolucency.
Radiographic non-fusion was defined as < 50% bony bridging at either the
superior or inferior graft interface OR > 4° angulation (motion) between
adjacent fused vertebrae on flexion/extension lateral films OR presence
of radiolucency.
5
Variables
Age (years)
Mean
Range
SD
Gender
Female
Male
Race
Caucasian
African-American
Hispanic
Asian
Other
Smoking Status
Nonsmoking
Smoking
Number of
Subjects
(N = 323)
46.8
24 – 73
9.3
148 (45.8%)
175 (54.2%)
301 (93.2%)
17 ( 5.3%)
5 ( 1.6%)
0
0
159 (49.2%)
164 (50.8%)
Control
(n = 160)
46.7
26 – 72
9.2
75 (46.9%)
85 (53.1%)
150 (93.8%)
7 ( 4.4%)
3 ( 1.9%)
-
-
79 (49.4%)
81 (50.6%)
Cervical-Stim
(n = 163)
46.9
24-73
9.4
73 (44.8%)
90 (55.2%)
151 (92.6%)
10 ( 6.1%)
2 ( 1.2%)
-
-
80 (49.1%)
83 (50.9%)
P-value1
0.846
0.706
0.703
0.958
Baseline Demographic Characteristics
Demographic Data
The subjects in this study had a mean age of 46.8 years (range 24 to 73 years).
Of the 323 subjects, 148 (45.8%) were female and 175 (54.2%) were male.
Three hundred one (93.2%) were Caucasian, while 17 (5.3%) were African
American and 5 (1.6%) were Hispanic. One hundred fifty-nine (49.2%) were
nonsmokers and 164 (50.8%) were smokers.

For purposes of device evaluation, all films were scanned into a central database
and reviewed by two independent, blinded orthopedic surgeons and a blinded,
independent radiologist following completion of the entire study. Films were
viewed and scored using a common protocol. All films at each time point were
evaluated for amount of radiolucency, bony bridging and degree of motion as
evidenced on the flexion/extension cervical spine films. A software program
was used to calculate motion. Results obtained in this fashion were reviewed
and verified by the reviewing orthopedic surgeons. The radiologist’s diagnosis
was considered definitive in the case of a disagreement between the two
orthopedic surgeons.
Effectiveness Results
Of the 323 subjects who were randomized and received surgery, 240 were
evaluable for the effectiveness analysis (Cervical-Stim treatment group, n=122;
control group, n=118). Subjects were deemed unevaluable for the following
reasons: non-existent or non-readable x-rays, subject non-compliance,
protocol violations (inclusion criteria), graft collapse, broken internal hardware,
early study exits due to minor adverse experiences, and one suicide attempt.
The success or failure of these subjects is not known. These unavailable data
could positively or negatively affect the overall success of the study. In order
to assess the impact of the missing data, sensitivity analyses were performed.
These included last observation carried forward and all missing data imputed
as non-fusion. Both of these analyses showed that the results at six months
were still statistically significantly different in favor of the Cervical-Stim group.
In addition, the baseline demographic data from the evaluable population was
compared to the demographic data of the missing subjects. The results of this
analysis indicated there were no significant differences between the evaluable
subjects and the non-evaluable subjects in 14 study variables including key
demographics and clinical parameters.
Primary Effectiveness Endpoint
The primary effectiveness endpoint was evidence of radiographic fusion at the
six month time point postoperative. At the six month time point, 102 of the
122 evaluable subjects (84%) in the Cervical-Stim treatment group were
judged to be fused versus 81 of the 118 evaluable subjects (69%) in the control
group (p=0.0065).
6
These data show that for patients undergoing cervical fusion surgery, patients
treated adjunctively with the Cervical-Stim experienced an increase in the
frequency of radiographic fusion at six months when compared to the control group.
Treatment Group
Control
Cervical-Stim
Number of Subjects
118
122
Number of Subjects
Fused
81
102
Fusion Rate (%)
68.64
83.61
Comparison of Radiographic Fusion utcomes at Six Months
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7
Treatment Group
Control
Cervical-Stim
Number of Subjects
120
125
Number of Subjects Fused
104
116
Fusion Rate (%)
86.67
92.80
verall Radiographic Fusion Fusion utcomes at 12 Months
Note: The differences in long-term success rates between treatment groups is not statistically
significant per Pearson x2test with the available sample size (x2= 2.5136, p = 0.1129).
An additional analysis was performed to allow for the differences between
the Cervical-Stim treatment group and the control group with respect to
demographic characteristics (gender, age, diagnosis) and risk status (smoking,
multilevel). The overall fusion rate in the Cervical-Stim group remained
statistically significant after adjustment for each of these variables.
Long-term follow-up (12 months) showed no statistical difference between the
two groups with respect to fusion. One hundred sixteen of the 125 evaluable
subjects (92.8%) in the Cervical-Stim treatment group were judged to be fused
at the long-term final endpoint, while 104 of the 120 evaluable subjects
(86.7%) in the control group were judged to be fused.
Secondary Effectiveness Endpoints
Secondary endpoints evaluated changes in clinical symptoms. A “clinical success”
with regard to symptoms was defined as no worsening in neurological function,
an improvement in VAS pain assessment and no worsening in Neck Disability
Index. A “clinical failure” with regard to symptoms was defined as failure for
any one of these criteria. There was no statistically significant difference
between the two groups with respect to the percent of subjects considered
a “clinical success” at six months (p=0.8456) or at 12 months (p=0.1129).

8
Safety
The adverse events observed in this study are shown in the Adverse vents
Table presented in the Prescription Information section. At six months, the
numbers of subjects who experienced one or more adverse events is similar
in the two groups. A total of 14 severe events were reported in 13 subjects;
nine of the subjects were in the Cervical-Stim treatment group and five
subjects were in the control group. These events included experiences such
as increased pain, shortness of breath, dizziness, unrelated trauma and injury,
unrelated death, surgical complication and adjacent level pathology. For the
nine subjects in the Cervical-Stim treatment group, all severe adverse events
were, in the judgment of the investigators, definitely or probably unrelated to
the device.
Safety data obtained between the six month visit and the final contact with
each subject indicate that 57 adverse events were experienced by a total of
51 subjects between both groups. The number of subjects who experienced
one or more adverse events is similar in the two groups. None of the adverse
events reported between the six month visit and the final contact were severe
and are similar to those reported at six months.
Device Life
The Cervical-Stim can provide up to 270 consecutive (daily) treatments of four
hours each. The overall length of treatment will be determined by the physician
based on the patient and progress toward fusion.
Treatment Time
The Cervical-Stim should be worn for four hours per day. At the end of the
daily treatment the device will turn itself off. The device may be turned off
at any time by simply pressing the On/Off button on the control panel.
The Cervical-Stim may be used at any time of day that is convenient for the
patient. It is lightweight and adjustable. And because the Cervical-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 the physician’s instructions.
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9
Charging/Recharging the Battery
The Cervical-Stim is powered by a rechargeable lithium-ion battery pack.
A charger unit is provided with the device. Use only the Orthofix charger
to charge the battery.
Note: The Cervical-Stim battery will require charging prior to the first use.
To charge/recharge the battery, simply plug the barrel connector end of the
charger unit into the charger port located on the control unit. Plug the line
cord securely into the charger unit. Plug the charger into any standard AC wall
outlet. A fully discharged battery will require approximately 4 hours to charge
completely.
The Cervical-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 Cervical-Stim will not deliver treatment while charging.
When the device is on, the Cervical-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 requires recharging.
See “Visual and Audio Indicators” for more information.
LCD
On/Off Button
Control Unit
Charger Unit
Charger Port

10
Device peration
Turning the Device n and ff
The Cervical-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. (If you do not see this on the display,
contact your provider.) A backlight button is on the control unit. In low light,
press the backlight button for illumination of the LCD.
Timing of Treatment Sessions
The Cervical-Stim automatically times each treatment session. The timing
begins when the device is turned on using the On/Off button on the control
unit. 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.
Control Unit
Charger
Port
IR Port
LCD
Flashing
Orthofix Logo
Backlight Button On/Off Button
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11
Wearing the Device
The Cervical-Stim is intended for the cervical spine and may be worn with or
without a brace. For better comfort, clothing should be worn between the
skin and the Cervical-Stim.
To use the Cervical-Stim, simply slip the device over the head so that it rests
comfortably against the neck and shoulders (see figure below). Or, the device
may be opened at the buckle and placed against the neck and shoulders.
Fasten the buckle like a seatbelt, to secure the unit.
A Comfort Collar is included with Cervical-Stim for improved fit and support.
The Comfort Collar can be inserted or removed from the inside collar of the
device using Velcro Tabs, which attach directly to the material.
Buckle
Joint
Velcro
Tab

12
Travel
Patients should be advised that when traveling by air, it is best to check the
Cervical-Stim with the luggage. If the device is taken on board the airplane,
it should not be worn when passing through passenger screening devices.
The Cervical-Stim could be damaged. The Cervical-Stim user manual should
be taken to quickly and easily identify the device for any security personnel.
Storage
The Cervical-Stim should be stored within 14ºF to 113ºF (-10º C to 45º C)
The Cervical-Stim operating temperature range should be within 41ºF to
104ºF (+5º C to 40º C)
Relative Humidity: Up to 95%, non-condensing
Disposal
This device contains lithium batteries. DO NOT dispose of
Cervical-Stim in an incinerator. Dispose of the device properly to
prevent injury.
Care and Cleaning
The Cervical-Stim is a sophisticated electronic device and should be handled
with care. Dropping or other mistreatment of the Cervical-Stim may cause
damage to the device.
DO NOT expose the Cervical-Stim to direct sunlight
for long periods of time. The device control unit may be damaged.
DO NOT expose the Cervical-Stim to excessive heat. In warm
climates, the temperature in a car or trunk can exceed 160ºF /
71ºC. xcessive heat can damage the control unit of the device.
DO NOT expose the Cervical-Stim to excessive moisture.
DO NOT dispose of the Cervical-Stim in an incinerator.
DO NOT use solvents to clean the Cervical-Stim.
Clean the device by wiping with a soft, damp cloth.
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13
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.
Cervical-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 code
(e.g., 01, 02 . . .)
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

14
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 II 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: Inspect the device prior to each use for wear or deterioration.
Do not use if the device does not appear to be in suitable condition.
Service
If you have questions concerning the device or require any assistance, please
contact your local distributor or visit www.orthofix.com for details. There are
no serviceable parts. Notify the manufacturer or local distributor for servicing
needs.
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Equipment Classification and Device Symbol Descriptions
Equipment Classifications
• Internally powered equipment
• Type BF applied part
• I C 529 enclosure rating: IPXO
• quipment 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 Instructions for Use
Type BF Applied Part
On/Off
Backlight Button
Storage Temperature Range
Year of Manufacture for Active Device
Charger Port

15
Conformance to Standards
The Orthofix Cervical-Stim Cervical Fusion System conforms to the following
worldwide series of standards:
UL 60601 - Medical lectrical quipment, General Requirements for Safety;
(including lectromagnetic Compatibility and Interference)
I C 60601 - Medical lectrical quipment, Safety Requirements for Medical
lectrical Systems (including lectromagnetic Compatibility and
Interference)
Warranty Information
Orthofix Inc. warrants the Cervical-Stim®bone growth stimulator 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 Inc. 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 Inc. 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 Inc. Attention: Orthofix Returns. You must call your local distributor
to obtain the Return Authorization (RA) number and address prior to returning
the product.
xcept as specifically required by applicable law, the foregoing warranty is in
lieu of all other warranties, expressed or implied and Orthofix Inc. specifically
disclaims any and all warranties of merchantability or fitness for a particular
purpose. Under no circumstances shall Orthofix Inc., 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 Inc. No sales person, representative, distributor or doctor is
authorized to make or consent to any extension or modification of the terms
of this Limited Warranty.
For additional information and/or device assistance, contact your local distributor.

INTERNATIONALE
VERSIE
HA ND LE I DI NG

Inhoudsopgave
Cervical-Stim®handleiding
Beschrijving van het apparaat ...................................................................... 1
De Orthofix-methode voor genezing ............................................................1
P MF-stimulatie ......................................................................................... 2
Informatie voor voorschrift ......................................................................... 2
Overzicht van klinische gegevens ................................................................ 3
Gegevensanalyse en resultaten .................................................................... 5
Doeltreffendheid - resultaten ...................................................................... 6
Veiligheid ................................................................................................... 8
Gebruiksduur van het apparaat ................................................................... 8
Behandelingsvoorschriften .......................................................................... 8
Laden/herladen van de batterij ..................................................................... 9
Gebruik van het apparaat .......................................................................... 10
Het apparaat dragen .................................................................................. 11
Onderhoud en reiniging ............................................................................. 12
Reizen ...................................................................................................... 12
Opslag ...................................................................................................... 12
Afvoer ...................................................................................................... 12
Visuele en geluidsindicators ....................................................................... 13
Classificatie apparatuur en beschrijving van symbolen op het apparaat ......... 14
Service ..................................................................................................... 14
Naleving van normen ................................................................................ 15
Garantie-informatie ................................................................................... 15
Ga voor meer informatie over Orthofix naar onze website
op www.orthofix.com.
Inhoud van de verpakking:
1- Cervical-Stim®cervicaal fusiesysteem
1- Literatuur
1- Laadeenheid #270215
I - Comfortkraag
DIT APPARAAT IS NI T ST RI L.
H T B HO FT G N ST RILISATI .
0086
Nederlands

1
De Cervical-Stim bestaat uit een regeleenheid en behandelingstransductor. De
regeleenheid bevat een microprocessor die het Cervical-Stim elektrisch signaal
produceert. Dit signaal wordt door de behandelingstransductor omgezet in een zeer
uniform, laag magnetisch veld. Wanneer het apparaat wordt gecentreerd over de te
behandelen plek, wordt het therapeutische Cervical-Stim P MF-signaal direct aan de
fusieplek geleverd.
De Cervical-Stim wordt gevoed door een oplaadbare lithium-ionbatterij.
De LCD en het geluidsalarm verwittigen de patiënt wanneer de batterij bijna leeg is en
moet worden opgeladen. Zie “Laden/herladen van de batterij” voor meer informatie.
Om te verzekeren dat het apparaat goed werkt, controleert de Cervical-Stim
voortdurend de batterijspanning en het elektrisch signaal. Als het apparaat op een
willekeurig moment tijdens de behandeling niet goed meer werkt, geeft de LCD een
overeenkomstig symbool of foutcode weer. Zie “Visuele en geluidsindicators” voor
meer informatie.
De rthofix-methode voor genezing
Orthofix is een erkende wereldwijde leider in P MF (gepulseerde elektromagnetische
veld) botgroeistimulatietechnologie. Orthofix ontwikkelde in 2005 de eerste niet-
invasieve, draagbare P MF-stimulator voor cervicale fusie met de lancering van het
Cervical-Stim cervicaal fusiesysteem. Orthofix blijft de levering van gepulseerde
elektromagnetische velden voor de genezing van cervicale wervelfusie en het redden
van gefaalde cervicale wervelfusie verfijnen en verbeteren. Orthofix produceert een
Beschrijving van het apparaat
Het Cervical-Stim®cervicaal fusiesysteem is een apparaat met een extern, laag,
gepulseerd elektromagnetisch veld (P MF) dat werd ontworpen met het comfort en
gemak van de patiënt in gedachten. Het is een uit één stuk bestaand apparaat dat licht,
flexibel en draagbaar is, waardoor het kan worden verplaatst tijdens de behandeling. en
Liquid Crystal Display (LCD) en geluidsalarm verschaffen belangrijke feedback tijdens de
behandeling zoals de bedrijfstatus, resterende behandelingstijd, batterijvermogen, etc. Zie
“Visuele en geluidsindicators” voor meer informatie.
Cervical-Stim cervicaal fusiesysteem - model 2505CE
Transductor
Gesp
Gewricht
Regeleenheid Bedieningspaneel