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Summary of Contents for Orthofix SS-5212
- Page 1 INST R UCT IO N MAN U AL Model 5212 SPINAL-STIM MANUAL SS-1602...
- Page 2 Assembled in the United States of America Spinal-Stim Device Patent No. U.S. 5,743,844 U.S. 6,132,362 U.S. 6,261,221...
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Page 3: Table Of Contents
• Failed Fusion Clinical Trial ..............Equipment Classification ................Compliance Statements ................Warranty ....................Device Box Components 1 – Spinal-Stim 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. -
Page 4: Prescription Information
Prescription Information Indications 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. -
Page 5: Device Information
Device Information Device Description Spinal-Stim stimulator is an external device that generates a Pulsed Electromagnetic Field (PEMF) as a nonsurgical, prescription treatment to increase the chances of a successful fusion. The device is lightweight, adjustable, and portable, including a rechargeable battery that allows freedom of movement during treatment. -
Page 6: Device Operation
Device Operation Turning the Device On and Off Spinal-Stim can be turned on by pressing and holding the On/Off Button on the Control Unit of the device until it beeps. When the device is turned on, a status screen will display the number of days since the first use, the treatment status, and the compliance percentage. -
Page 7: Treatment Instructions
Charging the Battery Spinal-Stim is powered by a rechargeable lithium-ion battery pack. 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). To ensure that the device is functioning properly, Spinal-Stim constantly monitors battery voltage and the electrical signal. - Page 8 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. 4. The LED on the power supply will light up green as an indicator that the AC Wall Outlet is delivering power.
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Page 9: Visual And Audio Indicators
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 – Displays a compliance percentage Compliance Screen which is calculated by the number of full treatments days completed over the number of available treatment days. -
Page 10: Wearing The Device
Wearing the Device Spinal-Stim can be worn over bracing and clothing. Proper treatment does not require direct contact with the body. However, the coils must be centered around the fusion site to be effective. Users can gently bend and shape the treatment coils to fit more comfortably around the body. - Page 11 The following is the suggested method for wearing Spinal-Stim: 1. Rest the Back Coil of the device 2. Sit in the chair. against the back of a chair and the Front Coil against the left arm of the chair. Let the Velcro Strap ®...
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Page 12: Sizing The Device
Sizing the Device For minor size adjustments, adjust the placement of the front Velcro Strap. For further adjustments, follow the steps below. 1. Place Spinal-Stim around the body to determine how much adjustment is needed. • Note: when properly adjusted, the coils should be centered on the body. - Page 13 4. If more strap length is needed to make the device bigger, slide the Back Clip toward the Strap Lock. Pull the excess strap through the Strap Lock. 5. If less strap length is needed to away from the Strap Lock to make the device smaller, push the tighten the excess strap.
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Page 14: Device Accessories
An accessory available to the patient is a user friendly mobile application which allows the patient to easily monitor their device use. This may be downloaded to the patient’s smartphone. Reference the Patient Guide to the Orthofix Stim App. Device Use and Care •... -
Page 15: Travel
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. You may also contact Orthofix Patient Services regarding recycling. Spinal-Stim is a Class III medical device (prescription only) that cannot be sanitized or used by another person. -
Page 16: Clinical Information
Clinical Information Clinical Data Summary Spinal-Stim was studied in human clinical trials to evaluate its safety and effectiveness as a therapy added to standard post-surgical care (referred to as the “adjunct clinical trial”). A separate phase of the clinical trial (referred to as the “failed fusion clinical trial”) examined patients with fusions that had not healed (pseudarthrosis) after a lumbar fusion surgery. -
Page 17: Failed Fusion Clinical Trial
Adjunct Clinical Trial: Overall Success Rate Active Placebo Consistent users (n=64) of the device in this phase had an initial success rate of 92.2% with a success rate of 70% after four years (a 24% reduction). Inconsistent users (n=34) and the entire placebo group (n=97) had an initial success rate of 65% with a success rate of 50% after four years (again, a 24% reduction). - Page 18 Failed Fusion Clinical Trial: Overall Success Rate Consistent Users Inconsistent Users 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).
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Page 19: Equipment Classification
Equipment Classification Device Symbol Descriptions Symbol Meaning Symbol Location Attention – Refer to Instruction Manual Device and Device Box Type BF Applied Part Device and Device Box Read Instructions for Use On/Off Device Prescription Only Device Storage Temperature Range Device Box Year of Manufacture for Active Device Device and Device Box Manufacturer... -
Page 20: Compliance Statements
(2) this device must accept any interference, including interference that may cause undesired operation of the device. IMPORTANT! Changes or modifications not expressly approved by Orthofix, Inc. could void the user’s authority to operate the equipment. NOTE: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. - Page 21 Information regarding Electromagnetic Compatibility and Immunity Spinal-Stim complies with IEC 60601-1-2 for electromagnetic compatibility (EMC). Spinal-Stim 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 Spinal-Stim.
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Page 22: Warranty
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. - Page 24 Orthofix Inc. 3451 Plano Parkway Lewisville, Texas 75056 Tel 214-937-2718 Patient Services 800-535-4492 toll free www.bonestimulation.com w w w . o r t h o f i x . c o m P/N 20115189 Rev.03 05/2016 SS-1602-US © Orthofix Holdings, Inc.
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