ORTHOFIX 5505CE Cervical Stim Instruction Manual

ORTHOFIX 5505CE Cervical Stim

Product Information

Specifications

• Model: 5505CE
• Country of Assembly: USA
• Patent Numbers: U.S. 6,024,691, U.S. 5,743,844, U.S. 6,132,362
• Manufacturer: Orthofix

Prescription Information

• Indication: The CervicalStim device is a noninvasive, pulsed electromagnetic bone growth stimulator indicated as an adjunct to cervical fusion surgery in patients at high-risk for non-fusion.
• Contraindication: There are no known contraindications for the CervicalStim device as an adjunct to cervical spine fusion surgery.

Adverse Effects Summary
Adverse effects may be experienced when using the CervicalStim device. These adverse effects may include increased pain, numbness and tingling, headache, migraines, and nausea. These effects may or may not be directly related to use of the CervicalStim device. Any adverse effects that are related to the CervicalStim device should stop when you discontinue use.

Device Information

• Device Description: The CervicalStim device is an external device that generates a Pulsed Electromagnetic Field (PEMF) signal 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.
• Device Operation: The CervicalStim device contains a Control Unit and a Treatment Coil in one integrated device. A micro-processor generates the CervicalStim device’s electrical signal, which is a highly uniform, low-energy electromagnetic field sent from the treatment coil. When the coil is centered over the treatment area, the therapeutic CervicalStim PEMF signal is delivered through clothing and skin directly to the fusion site.
• Device Life: The CervicalStim device 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.

Product Usage Instructions

Turning the Device On and Off

• The CervicalStim device can be turned on by pressing the On/Off Button on the Control Unit of the device.
• 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.

Positioning the Treatment Coil

• Before starting treatment, ensure that the treatment coil is centered over the fusion site. You can adjust the position of the treatment coil using the adjustable straps provided.
• Make sure that the treatment area is clean and free from any lotions, oils, or clothing that may interfere with the delivery of the PEMF signal.

Starting a Treatment Session

• Once the device is turned on and the treatment coil is properly positioned, press the Start button on the Control Unit to begin a treatment session.
• During the treatment session, the device will emit a low-energy electromagnetic field through the treatment coil, delivering the therapeutic PEMF signal to the fusion site.
• Follow the prescribed treatment time recommended by your physician. The LCD will display the remaining treatment time.

Ending a Treatment Session

• To end a treatment session, press the Stop button on the Control Unit. The device will stop emitting the PEMF signal.
• After each treatment session, clean the treatment coil with a damp cloth and store it in a safe place.

FAQ

1. Q: Can I use the CervicalStim device without undergoing cervical fusion surgery?
   A: No, the CervicalStim device is specifically indicated as an adjunct to cervical fusion surgery and should only be used under the guidance of a physician.

2. Q: How often should I use the CervicalStim device?
   A: The device provides daily treatments for up to 365 days. The frequency and duration of use will be determined by your physician based on your individual healing progress.

3. Q: Are there any side effects associated with using the CervicalStim device?
   A: Adverse effects may occur, including increased pain, numbness and tingling, headache, migraines, and nausea. These effects may or may not be directly related to the use of the device. If you experience any adverse effects, discontinue use and consult your physician

• Assembled in the United States of America CervicalStim Device Patent No
  • U.S. 6,024,691
  • U.S. 5,743,844
  • U.S. 6,132,362
• Device Box Components
  • 1 – CervicalStim Device
  • 1 – Power Supply
  • 1 – Literature Pack
• Orthofix Patient Services: 800-535-4492 or 214-937-2718
• To learn more about Orthofix, please visit our website at:
  • www.orthofix.com.

Prescription Information

Indication
The CervicalStim device is a noninvasive, pulsed electromagnetic bone growth stimulator indicated as an adjunct to cervical fusion surgery in patients at high-risk for non-fusion.
Contraindication
There are no known contraindications for the CervicalStim device as an adjunct to cervical spine fusion surgery.
Warnings

•  Do not use the CervicalStim device if you have a cardiac pacemaker or defibrillator because it may interfere with the operation of your pacemaker or defibrillator.
• If you use the CervicalStim device and it affects your pacemaker or defibrillator, it may injure your heart. Consult your cardiologist before using the CervicalStim device.
• Remove the CervicalStim device prior to any imaging procedures (e.g., CT scan, MRI, etc.). If you wear the CervicalStim device during these procedures, you could be injured, the imaging being produced may be ruined, and/or the CervicalStim device could be damaged.

Precautions

• Avoid using the CervicalStim device if you do not understand the instructions your doctor has given you. If you use the CervicalStim device incorrectly, it may harm you or may not help your healing process.
• The CervicalStim 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, rheumatoid arthritis, uncontrolled diabetes mellitus, patients prone to vascular migraine headache, seizure, epilepsy, thyroid conditions, or neurological diseases.
• Animal reproductive studies performed with this device did not show any harmful effects in animals. However, the safety of this device for use on patients who are pregnant or nursing has not been established.

Adverse Effects Summary

• Adverse effects may be experienced when using the CervicalStim device. These adverse effects may include increased pain, numbness and tingling, headache, migraines, and nausea. These effects may or may not be directly related to use of the CervicalStim device. Any adverse effects that are related to the CervicalStim device should stop when you discontinue use.
• See the Adverse Events Table for a list of all adverse events reported during the clinical study.
• Please refer to the Compliance Statements section of the manual for compatibility information regarding implantable medical devices.

Device Information

Device Description
The CervicalStim device is an external device that generates a Pulsed Electromagnetic Field (PEMF) signal 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.

How The CervicalStim Device 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.
• The CervicalStim device contains a Control Unit and a Treatment Coil in one integrated device. A micro-processor generates the CervicalStim device’s electrical signal, which is a highly uniform, low-energy electromagnetic field sent from the treatment coil. When the coil is centered over the treatment area, the therapeutic CervicalStim 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.BoneGrowthTherapy.com.

Device Life

• The CervicalStim device 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.

Device Operation

Turning the Device On and Off

• The CervicalStim device can be turned on by pressing the On/Off Button on the Control Unit of the device.

• 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.

• The CervicalStim device can be turned off by pressing and holding the On/Off Button on the Control Unit of the device until it beeps.

• The On/Off Button on the Control Unit doubles as a Backlight to light up the LCD. In low light, press the On/Off Button to light up the LCD.

Treatment Instructions

• The CervicalStim device should be worn for 4 hours each day as prescribed by a physician.
• The CervicalStim device may be used at any time of day that is most convenient for the patient.
• The device is programmed to reset daily at midnight Central Standard Time, unless adjusted by a physician or Orthofix representative for a different time zone or reset time.
• Hours worn before the reset time will be logged and stored in the device for daily use compliance.
• The overall treatment duration (months/weeks) will vary based on specific patient conditions as determined by a physician.
• Because the CervicalStim device is lightweight and portable, treatment can be received while sitting, walking, reclining, sleeping, etc. However, since each patient is unique, the overall activity level should be based on physician instructions.

Timing of Treatment Sessions

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

Charging the Battery

• The CervicalStim device 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, 20114794,
• WR9QA1200U23KIT(R6B), 20123808, 20123807, or 20123810).
• To ensure that the device is functioning properly, the CervicalStim device 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.
• The CervicalStim device should be charged before the first use and every day after completing treatment. Do not wear the device while charging. The device will not deliver treatment while charging.

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 the CervicalStim device where it will be difficult to unplug.
4. 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.
5. If the battery is fully depleted, it may require up to 4 hours to charge completely.
6. After charging is complete, remove the Charging Connector and replace the Charging Port Cover.

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.

• Compliance Screen
  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 Screen
  Treatment Screen – displays the treatment time remaining in hours and minutes. The timer counts down to zero until daily treatment is complete.

• Treatment Complete
  Daily Prescribed Treatment complete

• Charging Screen
  Battery Charging – Battery symbol filling repeatedly verifies that the device is charging.

• Charging Complete
  Charging Complete – Indicates when the battery is fully charged.

• Low Battery Warning Screen
  Low Battery – Displays along with three fast beeps when recharging is recommended.

• Battery must be charged to turn on
  Battery Empty – Indicates that the battery must be charged before treatment may continue.

• Device Expired
  Device Expired – Display of a closed lock indicates the device has been available for treatment for 365 days and will no longer provide a treatment..

• Exception Screen
  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.

Wearing the Device

• The CervicalStim device may be worn over a brace, cervical collar, halo, or clothing. Proper treatment does not require direct contact with the body. However, the coil must be centered around the fusion site to be effective. Users can gently bend and shape the treatment coil to fit more comfortably around the neck.

The following is the suggested method for wearing the CervicalStim device:

1. To put on the CervicalStim device, simply slip the device over your head.
2. For a wider opening, detach the Velcro® Tab near the control unit and place over your head.
3. The device does not need to be tight against the back of the neck; it should rest comfortably on your shoulders.

For additional comfort, a Comfort Collar is available as an accessory for the CervicalStim device. Please contact Patient Services at 800-535-4492 or 214-937-2718 to order.

Device Use and Care

• The CervicalStim device is for single patient use.
• The CervicalStim device is a technologically advanced electronic device and should be handled with care. Dropping or other mishandling of the CervicalStim device may damage the device and it may stop working.
• For safe usage, follow manufacturer instructions when using the CervicalStim device. 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, deterioration or damage.
• 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 could make it unsafe to use. Do not attempt to open or disassemble the CervicalStim device 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 CervicalStim 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 the CervicalStim device.
• DO NOT expose the CervicalStim device to excessive moisture.
• DO NOT use solvents or alcohol-based liquids (anti-bacterial cleaners, hand sanitizers, perfume, etc.) to clean the CervicalStim device.

Storage and Operating Environments

• When moving the CervicalStim device 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
• The CervicalStim device is designed for a storage life of twelve months plus one year of usage.

Travel

• When traveling by air, it is recommended to pack the CervicalStim device 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 CervicalStim device instruction manual should be taken with you to quickly and easily identify the device for security personnel. Do not wear or operate the CervicalStim device while onboard the airplane.

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.
• The CervicalStim device is a Class IIa for single patient use.
• The CervicalStim device 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 the CervicalStim device 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.

Clinical Information

• Clinical Data Summary
• The CervicalStim device was studied in humans to evaluate its safety and effectiveness as a therapy added to routine care (adjunct therapy) for high-risk patients having a cervical fusion surgery for degenerative conditions.  Patients were high-risk if they were a smoker (one pack per day or more) and/or had a multi-level fusion surgery (more than one level).
• The 323 patients were randomly assigned, to one of two groups: either the control group (routine care only) or the treatment group (CervicalStim device + routine care).  One hundred and sixty (160) patients were assigned to the control group and 163 patients were assigned to the CervicalStim device group.  Patients wore the CervicalStim device for 4 hours each day either for 4 continuous hours or in one hour sessions.
• Safety and effectiveness was evaluated by measuring the following:
  • Rate and severity of adverse events
  • Rate of cervical fusion by six months after surgery as determined by x-ray

Eighty-four percent (84%) of the CervicalStim device group were fused by six months (102/122 patients) versus only 69% of the control group (81/118 patients). This is a 15% difference between these two groups and is statistically significant (meaningful); p=0.0065. That is, more patients fused in the CervicalStim device group than in the control group.

• The rate of patients who came back for their six month examinations and x-rays was 74% for the CervicalStim device group and 73% for the control group.  Patients who did not come back for scheduled examinations could not be evaluated; thus their success or failure is not known.  These unavailable data could have a positive or negative effect on the overall success of this study.
• One hundred and twelve (112) patients reported a total of 157 adverse (negative) effects for both groups combined at six months after surgery. There was no significant (meaningful) difference in the total number of adverse events or the number of patients reporting effects in the control group and the CervicalStim device group nor in the numbers of patients in each group who experienced an adverse event. The adverse effects that may be experienced include: increased pain, numbness and tingling, headache, migraines and nausea. These effects may or may not be directly related to the use of the CervicalStim device.
• Clinical success with regard to symptoms was evaluated by the following:
  • no worsening in neurological function
  • an improvement in pain
  • no worsening in Neck Disability Index
• Based on the criteria above, there was no major difference between the control group and the CervicalStim device group in clinical success. An equal number of patients in both groups showed an improvement in their clinical condition after surgery, regardless of treatment.
• Long-term x-ray information collected at 11 months after surgery or later showed no meaningful difference in fusion rate between the CervicalStim device treatment group and the control group who received routine care alone.
• The results of this study show that the use of the CervicalStim device is both safe and effective in increasing the frequency of fusion by six months after surgery in high-risk subjects having cervical fusion.

Adverse Events Reported at 6 Months by Treatment Group Control Group (n=160) CervicalStim Device Group (n=163)

| Control Group (n=160)| CervicalStim Device Group (n=163)
---|---|---
Adverse Events| # (%) of Events| # (%) 1 of Patients Experiencing the Event| # *  (%) of Events| # (%) 1 of Patients Experiencing the Event
Increased Neck Pain| 10 (14.9)| 9(5.6)| 16(17.8)| 15(9.2)
Shoulder/Arm Pain| 10(14.9)| 9(5.6)| 16(17.8)| 16(9.8)
Re-Injury to Cervical Spine| 10(14.9)| 8(5,0)| 9(10.0)| 9(5.5)
Adjacent level pathology| 3(4.5)| 3(1.9)| 8(8.8)| 8(4.9)
Surgical Complications| 2(3.0)| 2(1.3)| 7(7.7)| 5(3.1)
LBP/Lumbar pathology| 8(11.9)| 8(5.0)| 5(5.5)| 5(3.1)
Trauma/Injury(not cervical)| 2(3.0)| 2(1.3)| 5(5.5)| 4(2.5)
Numbness/Tingling| 6(8.9)| 6(3.8)| 4(4.4)| 4(2.5)
Headache/Migraine| 2(3.0)| 2(1.3)| 4(4.4)| 4(2.5)
Nonspecific/Unrelated Pain| 2(3.0)| 2(1.3)| 3(3.3)| 3(1.8)
Nausea| 0| 0| 2(2.2)| 2(1.2)
Dizziness/Vertigo| 2(3.0)| 2(1.3)| 1(1.1)| 1(0.6)
Rash/Discoloration| 0| 0| 1(1.1)| 1(0.6)
Rapid/Irregular Heartbeat| 0| 0| 1(1.1)| 1(0.6)
Shortness of Breath| 0| 0| 1(1.1)| 1(0.6)
Ringing in Ears| 0| 0| 1(1.1)| 1(0.6)
Neurologic Symptom/Stroke| 1(1.5)| 1(0.6)| 1(1.1)| 1(0.6)
Lump in Throat| 0| 0| 1(1.1)| 1(0.6)
Diagnosis of Diabetes| 0| 0| 1(1.1)| 1(0.6)
Diagnosis of Breast Cancer| 0| 0| 1(1.1)| 1(0.6)
Seizure| 0| 0| 1(1.1)| 1(0.6)
Death, Unrelated| 0| 0| 1(1.1)| 1(0.6)
Tenderness| 1(1.5)| 1(0.6)| 0| 0
Screw Broken| 1(1.5)| 1(0.6)| 0| 0
Graft Collapse| 1(1.5)| 1(0.6)| 0| 0
Carpal Tunnel Syndrome| 2(3.0)| 2(1.3)| 0| 0
Choking Sensation| 1(1.5)| 1(0.6)| 0| 0
Cardiac Symptoms| 1(1.5)| 1(0.6)| 0| 0
Nephrotic Syndrome| 1(1.5)| 1(0.6)| 0| 0
Suicide Attempt| 1(1.5)| 1(0.6)| 0| 0
| | | |
TOTAL| 67| 472| 90| 582

% expressed as number of patients experiencing the event / total number of patients in the group Some patients experienced multiple adverse events

• There were several adverse events that were more frequently observed in the CervicalStim device group than in the control group. Given the types of events, it is unlikely that these adverse events are related to the treatment.

Equipment Classification

Device Symbol Descriptions

CervicalStim Device 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 greater than 12.5 mm and dripping liquids when tilted 15° from normal use. It is recommended you keep the unit dry.
• Mode of operation: intermittent operation
• This device is non-sterile. It does not require sterilization.
• Shelf life for equipment: 1 year
• 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:
  • Input: 100-240VAC, 50-60Hz, 200mA Output Voltage: 5VDC, 1.3A
• Orthofix#: 20123808:
• Input: 100-240VAC, 50-60Hz, 0.6-0.3A
• Output Voltage: 5VDC, 1.2A
• Orthofix #: 20123807:
• Input: 100-240VAC, 50-60Hz, 0.15A Output Voltage: 5VDC, 1.2A
• Orthofix # 20114794:
• Input: 100-240VAC, 50-60Hz, 150-350mA Output Voltage: 5VDC, 2.4A
• Orthofix#: WR9QA1200U23KIT(R6B):
• Input: 100-240VAC, 50-60Hz, 0.6A
• Output Voltage: 5VDC, 1.2A
• Orthofix #: 20123810:
• Input: 100-240VAC, 50-60Hz, 0.6-0.3A Output Voltage: 5VDC, 1.2A

Compliance Statements

• Hereby, Orthofix declares that the CervicalStim device Model 5505CE 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.

• If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:
  • Reorient or relocate the receiving antenna.
  • Increase the separation between the equipment and receiver.
  • Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
  • Consult the dealer or an experienced radio/TV technician for help.

Information regarding Electromagnetic Compatibility and Immunity

• The CervicalStim device complies with IEC 60601-1-2 for electromagnetic compatibility (EMC). The CervicalStim device needs special precautions regarding EMC and needs to be used in accordance with the EMC information provided in this manual. Wireless communications equipment such as home network devices, mobile phones, cordless telephones and their base stations, and walkie-talkies can affect the CervicalStim device.
• These types of equipment should be kept at least 0.198 m (7.8 in) away from the CervicalStim device.
• The CervicalStim device has not been evaluated with regard to use with specific implantable electronic medical devices. Please consult your physician prior to use of the CervicalStim device with implantable electronic medical devices.

Warranty

• Orthofix Inc. warrants the CervicalStim device 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 a Patient Services Representative or your local distributor to obtain the Return Authorization 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 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 physician 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 Orthofix Patient Services at 800-535-4492 or 214-937-2718.
• European Representative Orthofix Srl
  • Fax: 39 045 671 9380
• Orthofix
• 3451 Plano Parkway
• Lewisville, Texas 75056 USA
• Tel 214-937-2718
• Patient Services
• United States 800-535-4492 or 214-937-2718 Australia 1 800 870 395
• Australian Sponsor
• Emergo Australia
• Level 20, Tower II
• Darling Park
• 201 Sussex Street
• Sydney, NSW 2000
• Australia
  • Orthofix.com
  • BoneGrowthTherapy.com
  • P/N 20122316 Rev. AJ 2023-06-09 CS-2302 © Orthofix US LLC

References

• Bone Growth Stimulator Devices | Orthofix Bone Growth Therapy
• Orthofix - Medical Devices & Solutions
• Bone Growth Stimulator Devices | Orthofix Bone Growth Therapy
• Bone Growth Stimulator Devices | Orthofix Bone Growth Therapy
• Orthofix - Medical Devices & Solutions

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