Orthofix SS-5212, Instruction Manual

Page 1: ...Model 5212 INSTRUCTION MANUAL USA SPINAL STIM MANUAL SS 1602 DRAFT 5 02 16 DO NOT DISTRIBUTE FINAL WILL BE PROVIDED ONCE APPROVED ...

Page 2: ...Spinal Stim Device Patent No U S 5 743 844 U S 6 132 362 U S 6 261 221 Assembled in the United States of America ...

Page 3: ...g the Device Sizing the Device Device Accessories Device Use and Care Care and Cleaning Storage Travel Disposal Service Clinical Information Clinical Data Summary Adjunct Clinical Trial 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 le...

Page 4: ...term adverse effects from the use of a similar device However long term effects in humans are unknown Precautions This device should not be used if there are mental or physical conditions which preclude compliance with the physician and device instructions This device has not been evaluated in treating patients with the following conditions osseous or ligamentous spinal trauma spondylitis Paget s ...

Page 5: ...reatment Coil LCD Control Unit Spinal Stim contains a Control Unit and Treatment Coils in one integrated device A micro processor generates Spinal Stim s electrical signal which is a highly uniform low energy magnetic field sent from the treatment coils When the coils are centered over the treatment area the therapeutic Spinal Stim PEMF signal is delivered through clothing and skin directly to the...

Page 6: ... LCD will show the prescribed treatment time remaining and the battery status The flashing semicolon on the LCD screen and On Off button indicate that the device is on and delivering treatment Spinal Stim 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 lo...

Page 7: ...hargeable 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 The LCD will display a battery capacity symbol and the device will beep to alert the patient ...

Page 8: ...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 6 If the battery is fully depleted it may require up to 4 hours to charge completely 7 After charging is complete remove the Charging Connec...

Page 9: ... Battery Empty Indicates that the battery must be charged before treatment may continue Device Expired Display of a closed lock indicates the device has been available for treatment for 365 days and will no longer provide treatment Compliance Screen 170 185 91 9 Compliance Screen Displays a compliance percentage which is calculated by the number of full treatments days completed over the number of...

Page 10: ...racing 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 2 00 ...

Page 11: ...et the Velcro Strap hang over the right arm of the chair 4 Locate the Velcro Strap and pull it snugly across your body and attach it to the Velcro Panel on the Front Coil 2 Sit in the chair 3 Pull the Front Coil toward you and let it rest on top of your legs 2 00 The following is the suggested method for wearing Spinal Stim ...

Page 12: ... around the body to determine how much adjustment is needed Note when properly adjusted the coils should be centered on the body The Control Unit should be in front LCD facing up 2 If a significant size adjustment is needed lay the unit flat with the outside of the device Velcro Panel facing up Control Unit Velcro Panel Front Coil Strap Lock Strap Lock Side Clip Velcro Strap Back Coil Back Coil Ba...

Page 13: ...xcess strap 6 Close the Strap Lock 7 On the back coil adjust the Velcro Strap by pulling more or less elastic strap through the Side Clip 8 When properly adjusted the Spinal Stim straps will be approximately the same length on each side 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 ...

Page 14: ...of the device Inspect the device prior to each use for wear or deterioration Do not use the device if it does not appear to be in suitable condition Do not attempt to open or disassemble Spinal Stim as there are no user serviceable parts inside CAUTION STRANGULATION HAZARD Keep the Power Supply cord out of the reachof children Care and Cleaning When cleaning the Spinal Stim device follow these ins...

Page 15: ...irplane 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 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 Dispose of the device properly to pr...

Page 16: ...atients using active devices on a consistent daily regimen an average of at least two hours per day developed solid fusion in 92 2 of the cases 1 Patients consistently using placebo inactive devices developed solid fusion in 67 9 of the cases This 35 increase in treatment effect is statistically significant and is realized regardless of At one year after the fusion surgery patients using active de...

Page 17: ...ng term success rates appears unrelated to treatment with the Spinal Stim During this four year period 10 of the original patients in the randomized double masked phase were lost to follow up and are not reflected in these success rates Failed Fusion Clinical Trial Spinal Stim was also tested for nonoperative salvage in patients presenting with established pseudarthrosis of lumbar fusion in an ope...

Page 18: ...four years The reduction in success rates from the time of commercial marketing compared with those at four years showed a similar percentage decrease 31 to those in the randomized double masked trial During this four year period 6 of the original patients in the open phase were lost to follow up and are not reflected in these success rates 1 Mooney V A Randomized Double Blind Prospective Study of...

Page 19: ...ange Device Box Year of Manufacture for Active Device Device and Device Box Manufacturer Instruction Manual Not for General Waste Device and Device Box Keep Dry Device and Device Box FCC Mark Device and Device Box CE Mark Device and Device Box Storage Humidity Limits Device and Device Box EU Authorized Representative Instruction Manual Catalog Number Device and Device Box Serial Number Device and ...

Page 20: ...d in accordance with the instructions may cause harmful interference to radio communications However there is no guarantee that interference will not occur in a particular installation 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...

Page 21: ...cations equipment such as home network devices mobile phones cordless telephones and their base stations and walkie talkies can affect Spinal Stim These types of equipment should be kept at least 0 198 m 7 8 in away from Spinal Stim This device complies with Part 15 of the FCC Rules Operation is subject to the following two conditions 1 this device may not cause harmful interference and 2 this dev...

Page 22: ... 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 circumst...

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Page 24: ...189 Rev 03 05 2016 SS 1602 US Orthofix Holdings Inc Caution Federal law USA restricts this device to sale by or on the order of a physician Orthofix Inc 3451 Plano Parkway Lewisville Texas 75056 Tel 214 937 2718 Patient Services 800 535 4492 toll free ...