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.
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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.