Orthofix 5212CM SpinalStim Device Instruction Manual

: June 15, 2024
: ORTHOFIX

Table of Contents

Orthofix 5212CM SpinalStim Device
Product Information
Prescription Information
Device Information
Device Operation
Device Accessories
Storage and Operating Environments
Clinical Information
Equipment Classification
Compliance Statements
Warranty
References
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Orthofix 5212CM SpinalStim Device

Product Information

Specifications

Model : 5212CM
Country of Assembly : United States of America
Device Patent Numbers : U.S. 5,743,844, U.S. 6,132,362, U.S. 6,261,221

Device Accessories
The SpinalStim device comes with the following accessories

Front Treatment Coil
Back Treatment Coil
Control Unit
Charging Port

Device Use and Care
To ensure proper use and longevity of the SpinalStim device, please follow these guidelines

Avoid dropping or exposing the device to excessive heat or moisture.
Keep the device clean by wiping it with a soft, dry cloth.
Do not attempt to disassemble or modify the device.
Store the device in a cool and dry place when not in use.

Prescription Information

Indications
The SpinalStim device is indicated for the following purposes

Spinal fusion adjunct to increase the probability of fusion success.
Nonoperative treatment of salvage of failed spinal fusion, where at least nine months have passed since the last surgery.

Contraindication
Use of the SpinalStim device is contraindicated for individuals with implanted cardiac pacemakers, as exposure to PEMF may adversely affect the pacemaker.

Adverse Effects: Rare instances of reversible minor discomfort have been reported, including

Cumbersome or uncomfortable sensation
Minor tingling or pain
Minor skin rash
Insomnia
Fainting
Nausea/diarrhea
Polymenorrhea

Please refer to the Compliance Statements section of the manual for compatibility information regarding implantable medical devices.

Device Operation

Turning the Device On and Off
To turn on the SpinalStim device

Press and hold the On/Off Button on the Control Unit until it beeps.
A status screen will display the number of days since the first use, treatment status, and compliance percentage.
The LCD will show the prescribed treatment time remaining and battery status.
The flashing colon on the LCD screen and On/Off button indicate that the device is on and delivering treatment.

To turn off the SpinalStim device

Press and hold the On/Off Button on the Control Unit until it beeps.

The On/Off Button on the Control Unit also functions as a backlight to illuminate the LCD. Press the button in low light to light up the LCD.

Device Life
The SpinalStim device provides daily treatments for up to 365 days. The overall length of treatment (months/weeks) is determined by the physician based on the individual’s fusion healing progress.

FAQ

Q: Can the SpinalStim device be used with a cardiac pacemaker?
A: No, the use of the SpinalStim device is contraindicated for individuals with implanted cardiac pacemakers.
Q: How should I clean the SpinalStim device?
A: You can clean the device by wiping it with a soft, dry cloth. Do not use any liquid cleaners or immerse the device in water.
Q: Can I disassemble or modify the SpinalStim device?
A: No, you should not attempt to disassemble or modify the device. Doing so may damage the device and void the warranty.

Prescription Information

Indications
The SpinalStim device 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.

Contraindication
Cardiac pacemakers may be adversely affected by exposure to PEMF. Use of this device is contraindicated where the individual has an implanted cardiac pacemaker.

Warnings

Although animal teratological studies performed with the device demonstrated no adverse findings, the safety of use of this device during pregnancy and nursing in humans has not been established.
The safety and effectiveness of the use of this device on individuals lacking skeletal maturity have not been established.
Animal studies conducted to date do not suggest any long-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 disease, moderate to severe osteoporosis, metastatic cancer, renal disease, and uncontrolled diabetes mellitus.
The results of premarketing data from the randomized double-masked cohort indicate that inconsistent users (defined as those patients that used the device for less than an average of two hours per day) had success rates similar to those in the placebo group. Therefore, the use of the device for less than the minimum recommended usage may result in lower success rates.

Adverse Effects
Rare instances of reversible minor discomfort have been reported. These were: cumbersome or uncomfortable, minor tingling or pain, minor skin rash, insomnia, fainting, nausea/diarrhea, and polymenorrhea.
Please refer to the Compliance Statements section of the manual for compatibility information regarding implantable medical devices.

Device Information

Device Description
The SpinalStim device 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. A Liquid Crystal Display (LCD) and audible indicators provide important feedback during treatment. See “Device Operation” for more information.

How the SpinalStim 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 SpinalStim device contains a Control Unit and Treatment Coils in one integrated device. A micro-processor generates the SpinalStim device’s electrical signal, which is a highly uniform, low-energy electromagnetic field sent from the treatment coils. When the coils are centered over the treatment area, the therapeutic SpinalStim device 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 SpinalStim 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 SpinalStim device can be turned on by pressing 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.
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 SpinalStim 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 SpinalStim device should be worn each day for the number of hours prescribed by a physician (a minimum of 2 hours/day).
The SpinalStim device may be used at any time of day that is most convenient for the patient.
The device is programmed to reset the treatment clock daily at midnight Central Standard Time, unless adjusted by a physician or Orthofix representative for a different time zone.
Hours worn prior to the reset time will be logged and stored in the device for monitoring daily use compliance.
The overall treatment duration (number of months/weeks) will vary based on specific patient conditions as determined by a physician.
Because the SpinalStim 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 SpinalStim 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 treatment time.
When daily treatment is completed, the device will automatically turn off.

Charging the Battery

The SpinalStim 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 SpinalStim 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 SpinalStim 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:

Open the Charging Port Cover.
Plug the Charging Connector into the Charging Port located on the Control Unit.
Plug the power supply into any standard AC Wall Outlet. Do not plug in the power supply for the SpinalStim device where it will be difficult to unplug.
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.
If the battery is fully depleted, it may require up to 4 hours to charge completely.
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 – 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 – displays the treatment time remaining in hours and minutes. The timer counts down to zero until daily treatment is complete.
Daily Prescribed Treatment complete
Battery Charging – Battery symbol filling repeatedly verifies that the device is charging.
Charging Complete – Indicates when the battery is fully charged.
Low Battery – Displays along with three fast beeps when recharging is recommended.
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.
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 SpinalStim device 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.

The following is the suggested method for wearing the SpinalStim device

Rest the Back Coil of the device against the back of a chair and the Front Coil against the left arm of the chair. Let the Velcro® Strap hang over the right arm of the chair.
Sit in the chair.
Pull the Front Coil toward you and let it rest on top of your legs.
Locate the Velcro Strap and pull itcsnugly across your body and attach it to the Velcro Panel on the Front Coil.

Sizing the Device
For minor size adjustments, adjust the placement of the front Velcro Strap. For further adjustments, follow the steps below.

Place the SpinalStim device 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.
If a significant size adjustment is needed, lay the unit flat with the outside of the device Velcro Panel facing up.
To adjust the Back Coil, open the Strap Lock.
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.
If less strap length is needed to make the device smaller, push the desired amount of strap through the Strap Lock. Slide the Back Clip away from the Strap Lock to tighten the excess strap.
Close the Strap Lock.
On the back coil, adjust the Velcro Strap by pulling more or less elastic strap through the Side Clip.
When properly adjusted, the SpinalStim device straps will be approximately the same length on each side.

Device Accessories

Certain body types may benefit from the use of suspenders with the SpinalStim device. Please contact Patient Services at 800-535-4492 or 214-937-2718 to order suspenders.

Device Use and Care

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

Storage and Operating Environments

When moving the SpinalStim 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 SpinalStim 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 SpinalStim 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 SpinalStim device instruction manual should be taken with you to quickly and easily identify the device for security personnel. Do not wear or operate the SpinalStim 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 SpinalStim device is a Class 2 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 SpinalStim 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 or 214-937-2718. There are no user serviceable parts. Notify Orthofix for any servicing needs.

Clinical Information

Adjunct Clinical Trial
The SpinalStim device has been tested in a clinical study involving 54 surgeons at 31 centers. This clinical investigation contained a prospective randomized double-masked trial of PEMF efficacy. The SpinalStim device was tested as a surgical adjunct in patients undergoing a first attempt at lumbar fusion. At one year postoperative, patients 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

Number of levels
Graft type
Internal fixation
Gender
Vertebral level
Smoking
Age

The success rate for patients in the randomized double-masked phase for whom success or failure status is known at four years after treatment with the SpinalStim device for all subjects (consistent and inconsistent users combined) was 63% (n=88) as compared with 83% in this phase of the clinical trial (i.e., one year postoperative). 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). Long-term follow-
up data indicates the success rate differentials between active and placebo units
are maintained over time. Long-term, consistent SpinalStim device users benefit with a 40% increase in fusion success, when compared to inconsistent and placebo device users. Based on this analysis, the reduction in long-term success rates appears unrelated to treatment with the SpinalStim device. 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
The SpinalStim device was also tested for nonoperative salvage in patients presenting with established pseudarthrosis of lumbar fusion in an open trial. Without concomitant regrafting, 67% of these cases reached a successful fusion with consistent (an average of at least 2 hours per day) PEMF treatment.2
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). Consistent users (n=93) of the device in this phase had a success rate of 44% after four years. Inconsistent users (n=26) of the device in this phase had a success rate of 19% after 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.
1Mooney, V., “A Randomized Double-Blind Prospective Study of the Efficacy of Pulsed Electromagnetic Field for Interbody Lumbar Fusions”, SPINE, Vol. 15, No. 7, P708, 1990.
2Simmons, JW, Hayes, MA, Christensen, KD, Dwyer, AP, Koulisis, CW, Kimmich, SJ: “The Effect of Postoperative Pulsed Electromagnetic Fields on Lumbar Fusion: Open Trial Study”. Presented at the Annual Meeting of the North American Spine Society, Quebec City, Canada, 2 July 1989.

Equipment Classification

Device Symbol Descriptions

SpinalStim 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 a peak intensity of 30 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 > 12.5mm and dripping liquids when tilted 15° from normal use. It is recommended you keep the unit dry.
- Shelf life for equipment: 1 year
- Mode of operation: intermittent operation
- This device is non-sterile. It does not require sterilization.
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

This device complies with Industry Canada licence-exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired opera-tion of the device.
IMPORTANT! Changes or modifications not expressly approved by Orthofix, Inc. could void the user’s authority to operate the equipment.

CAN ICES-3(B)/NMB-3(B)
This equipment complies with radiation exposure limits set forth for uncontrolled environ-ment.
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 SpinalStim device complies with IEC 60601-1-2 for electromagnetic compatibility (EMC). The SpinalStim 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 SpinalStim device. These types of equipment should be kept at least 0.198 m (7.8 in) away from the SpinalStim device.
The SpinalStim device has not been evaluated with regard to use with specific implantable electronic medical devices. Please consult your physician prior to use of the SpinalStim device with implantable electronic medical devices.

Warranty

Orthofix Inc. warrants the SpinalStim 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.

Assembled in the United States of America
SpinalStim Device Patent No.