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Summary of Contents for bioMetric SpinalPak
- Page 1 Biomet SpinalPak ® ® Non-invasive Spine Fusion Stimulator System Complete Manual and Package Insert...
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Page 2: Table Of Contents
Table of Contents SYSTEM CONTENTS ........................1 IMPORTANT SAFEGUARDS ......................2 BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM ......3 ® ® • Description ..........................3 • Electrical Requirements for Battery Pack and Charger ............3 SYSTEM COMPONENTS ......................3,4 FULL PRESCRIBING INFORMATION .....................5 • Indications for Use ........................5 • Warnings, Precautions, Adverse Effects ................5 DIRECTIONS FOR USE ........................6 • Recommended Usage ......................6... -
Page 3: System Contents
System Contents • Electrodes - Soft Touch - 72R ® • Electrodes - Soft Touch - LT-4500 ® • Charger Cradle • Rechargeable Battery Packs (2) • Electrode Covers • Stimulator • Device Holster • Lead Wires - 20” Lead Wire and 48” Lead Wire • Patient Manual • Complete Manual and Package Insert • A/C Adaptor... -
Page 4: Important Safeguards
1. Do not use this product while bathing, showering or swimming. 2. Do not place or store this product where it can fall or be pulled into a tub or sink. 3. Do not immerse the stimulator, battery charger or the battery in water or any liquid. 4. Do not reach for this product if it has fallen into water. Unplug from the wall outlet immediately. 5. Do not permit the battery charger to be connected when wet. 6. Do not touch the battery contacts when the battery charger is plugged into an outlet. 7. N ever operate the battery charger if it has a damaged power cord, plug or if it is not working properly. Do not use if it has been dropped and damaged, or immersed into water. Contact Biomet for return instructions. 8. D o not attempt to charge any other type of battery pack in the Biomet SpinalPak Non-invasive ® ® Spine Fusion Stimulator System battery charger. 9. Keep all cords away from heated surfaces 10. Never insert any foreign object into any opening of the system. 11. D o not expose the stimulator or the battery charger to prolonged heat or direct sunlight. (Normal operating temperature range is 5°C to 38°C [41°F to 100°F], normal storage/transport temperature is -15°C to 50°C [5°F to 122°F]. 12. Use this product only for its intended use as described in this manual. -
Page 5: Biomet ® Spinalpak ® Non-Invasive Spine Fusion Stimulator System
Caution: Federal Law (U.S.A.) restricts this device to sale by or on the order of a physician. Rx Only. Figure 1 This device is not intended for re-sale or re-distribution. Single patient use. DESCRIPTION The Biomet SpinalPak Non-invasive Spine Fusion Stimulator System (Figure 1) promotes healing ® ® by inducing a low electrical current at the fusion site. The therapeutic signal generates a low energy electrical field by passing a specific current between the electrodes. ELECTRICAL REQUIREMENTS FOR BATTERY AND CHARGER... -
Page 6: System Components
Battery temperature is too low or high Normal operating temperature is 5°C to 38°C [41°F - 100°F] Battery voltage is too low Call Biomet for a new battery pack Electrodes There are two types of electrodes that are packaged with the Biomet SpinalPak Non-invasive Spine ® ® Fusion Stimulator System assembly: 72R and LT-4500. The 72R electrodes have green writing on their packaging. The LT-4500 electrodes have black writing on their packaging. The 72R electrodes have a hydrogel that is stickier than the LT-4500 electrode hydrogel. The patient can use whichever electrodes best suit their skin type. -
Page 7: Full Prescribing Information
Full Prescribing Information INDICATIONS FOR USE The Biomet SpinalPak Non-invasive Spine Fusion Stimulator System is a noninvasive spine fusion ® ® stimulator indicated as an adjunct electrical treatment to primary lumbar spinal fusion surgery for one or two levels. WARNINGS Cardiac pacemakers or cardioverters may be adversely affected by the Biomet SpinalPak ® ® Non-invasive Spine Fusion Stimulator System. The concomitant use of the device and a pacemaker or cardioverter must be assessed on an individual basis, such as with an electrocardiogram, prior to use. The patient should be referred to a cardiologist for monitoring of pacemaker function while wearing the active Biomet SpinalPak Non-invasive Spine Fusion Stimulator System device. If there are any ® ® observable adverse changes in the pacemaker rhythm or output, the device should not be used. The safety and effectiveness of the Biomet SpinalPak Non-invasive Spine Fusion Stimulator System ®... -
Page 8: Directions For Use
Directions for Use RECOMMENDED USAGE The Biomet SpinalPak Non-invasive Spine Fusion Stimulator System is designed to deliver 270 ® ® days of continuous therapeutic treatment for 24 hours per day. The recommended daily therapeutic treatment is continuous for 24 hours. OPERATING INSTRUCTIONS The Biomet SpinalPak Non-invasive Spine Fusion Stimulator System has been specifically designed ® ® to be convenient to use, comfortable to wear, and safe to operate. Patients should begin using the... -
Page 9: Operating Instructions
Operating Instructions Both battery packs provided with the Biomet SpinalPak Non-invasive Spine Fusion Stimulator ® ® System are charged prior to being packaged and distributed. Upon receipt of the Biomet SpinalPak ® ® Non-invasive Spine Fusion Stimulator System, it is recommended that the second battery pack be immediately placed into the charger cradle and completely charged. In the meantime, the first battery pack may be used to begin your treatment immediately. Note: The first battery pack may not provide a complete 24-hour treatment initially. - Page 10 Remove the battery pack (1, 2) from the battery charger cradle with a gentle lift on the battery tab (Figure 9) and place the fully charged battery pack into the Biomet SpinalPak ® ® Non-invasive Spine Fusion Stimulator System in order to commence treatment.
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Page 11: Button Functions
Button Functions ALARM ON/OFF BUTTON The Biomet SpinalPak Non-invasive Spine Fusion Stimulator System is activated as soon as a ® ® charged battery pack is inserted. The button located below the LCD display enables or disables the audible alarm. During an alarm condition, depressing the button quickly (0.5 seconds) will temporarily disable the audible alarm. Depressing the button for a longer period of time (3 seconds) will toggle the audible alarm between enabled and disabled. Patients should be advised to leave the audible alarm enabled as frequently as possible in order to assure the fully prescribed treatment. A speaker symbol... -
Page 12: Treatment Completion
Treatment Completion Therapeutic treatment should not be suspended until fusion occurs or until such time as a determination is made by the prescribing physician. The device is programmed to deliver 270 continuous days of therapeutic treatment and automatically discontinues operation after the 270 days. Patient Compliance Monitoring The Biomet SpinalPak Non-invasive Spine Fusion Stimulator System contains embedded software ® ® which allows the display of patient specific history data including usage and therapeutic treatment times. This data may be downloaded to a personal computer for viewing, storage and/or print out via the use of Biomet Compliance Data Download Software. Please call your local Biomet representative to obtain more information. -
Page 13: Symbol Description
Type B Warning: The concomitant use of the stimulator and a Storage/Transport pacemaker or cardioverter temperature limits must be assessed by a cardiologist on an individual basis with an Class II Electrocardiogram (EKG). Non Sterile Caution: The safety of this device used during pregnancy and nursing in humans has not been established. Manufacturer Equipment Classification • Stimulator - Internally powered by rechargeable batteries • Charger - Class II, Type B • Ordinary Equipment without protection against ingress of water • Equipment not suitable for use in presence of flammable anesthetic mixture with air or oxygen or nitrous oxide. • Mode of operation - continuous Cleaning Instructions Use a damp cloth for cleaning any part of the Biomet SpinalPak Non-invasive Spine Fusion ® ® Stimulator System. Do not use cleaning products or detergents. -
Page 14: Electromagnetic Compatibility
Electromagnetic Compatibility A. T he use of accessories, cables or replacement parts other than those supplied by Biomet may result in increased emissions or decreased immunity of the equipment or system. B. T his equipment should not be used adjacent to or stacked upon other equipment. C. P ortable and mobile RF communications equipment can adversely affect the operation of Medical Electrical Equipment. D. I n the event this equipment interferes with the operation of other equipment, or experiences interference from other equipment, to continue treatment, it will be necessary to move the Biomet SpinalPak Non-invasive Spine Fusion Stimulator System away from the source of the ® ® interference as indicated in Table 4. Table 1 Guidance and manufacturer’s declaration - electromagnetic emissions The Biomet SpinalPak Non-invasive Spine Fusion Stimulator System is intended for use in the ®... - Page 15 Table 2 Guidance and manufacturers declaration - electromagnetic immunity The Biomet SpinalPak Non-invasive Spine Fusion Stimulator System is intended for use in the ® ® electromagnetic environment specified below. The customer or the user of the Biomet SpinalPak ® ® Non-invasive Spine Fusion Stimulator System should assure that it is used in such an environment. IEC 60601 Electromagnetic environment - Immunity test Compliance level test level guidance Electrostatic Floors should be wood, concrete or ± 6 kV contact discharge (ESD) ceramic tile. If floors are covered with Group 1 synthetic material, the relative humidity ± 8 kV air IEC 610004-2 should be at least 30 %.
- Page 16 To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Biomet SpinalPak Non-invasive Spine Fusion Stimulator System is used exceeds ® ® the applicable RF compliance level, the Biomet SpinalPak Non-invasive Spine Fusion Stimulator ® ® System device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Biomet SpinalPak ®...
- Page 17 Table 4 Recommended separation distances between portable and mobile RF communications equipment and the Biomet ® SpinalPak Non-invasive Spine Fusion Stimulator System ® The Biomet SpinalPak Non-invasive Spine Fusion Stimulator System is intended for use in an ® ® electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Biomet SpinalPak Non-invasive Spine Fusion Stimulator System can help prevent electromagnetic ® ® interference by maintaining a minimum distance between portable and mobile communications equipment (transmitters) and the Biomet SpinalPak Non-invasive Spine Fusion Stimulator System as recommended ®...
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Page 18: Patient Counseling Information
The Non-invasive Spine Fusion Stimulator System should be stored in a cool and Biomet SpinalPak ® ® dry place. The device components should be handled with care. Damage may occur if the device is inappropriately handled or abused. Disposal Instructions When treatment has concluded as determined by the prescribing physician (see page 10), Biomet requests that the patient disposes of the Non-invasive Spine Fusion Stimulator Biomet SpinalPak ® ® System according to local statutes and regulations. - Page 19 Notes:...
- Page 20 OPTIONS The industry’s most comprehensive options: • PEMF, CC and DC • Anatomy specific coils • Wear-time choice EVIDENCE • Backed by proven science • Multiple scientific papers • The proof is in the patient EXPERIENCE Recognized as an industry pioneer with EBI lineage, Biomet has helped over one million people Biomet SpinalPak Non-invasive ® ® Spine Fusion Stimulator System Complete Manual and Package Insert To learn more about this product, contact your local Biomet Sales Representative today. PN # 1067795-00 Rev. D 399 Jefferson Road • Parsippany, NJ 07054 800.526.2579 • www.biomet.com • BNS231002L 11/13 ©2013 EBI, LLC. All trademarks are the property of Biomet, Inc. or one of its subsidiaries unless otherwise indicated. Rx Only.
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