ORTHOFIX 5302CM HysioStim Device Instruction Manual

ORTHOFIX 5302CM HysioStim Device

 **Instruction Manual**

Assembled in the United States of America

PhysioStim Device Patent No.
5743844
6132362

Prescription Information

Indication
The PhysioStim™ device is indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones, where the width of the nonunion defect is less than one-half the width of the bone to be treated. A nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing.

Contraindication
Use of this device is contraindicated where the individual has synovial pseudarthrosis.

Warnings

• The safety and effectiveness of the use of this device on individuals lacking skeletal maturity has not been established.
• In the presence of a malaligned nonunion, careful consideration of the use of this device must be undertaken on an individual basis, as treatment with this device is not intended to alter or affect the degree of malalignment.
• Demand type pacemaker operation may be adversely affected by exposure to pulsed electromagnetic fields. Physicians should not prescribe a PhysioStim device for application which may place the treatment transducer in close proximity to the pacemaker. Further screening by the attending cardiologist is recommended (such as with an electrocardiogram).
• Animal studies conducted to date do not suggest any long-term adverse effects from the use of this device. However, long-term effects in humans are unknown.
• The safety and effectiveness of this device on individuals with a nonunion secondary to, or in connection with, a pathological condition has not been established.

Precautions

• Nonunion fractures with gaps in excess of 1 centimeter (cm) have not been evaluated.
• Although animal reproductive studies performed with this device demonstrated no adverse findings, the safety of use of this device during pregnancy and nursing in humans has not been established.
• This device should not be used if there are mental or physical conditions which preclude patient compliance with physician and device instructions.

Adverse Events

Rare instances of reversible minor discomfort have been reported. They were: cumbersome or uncomfortable, tingling or pain and minor skin rash.
Please refer to the Compliance Statements section of the manual for compatibility information regarding implantable medical devices.

Device Description

The PhysioStim device is an external unit that generates a Pulsed Electromagnetic Field (PEMF) signal as a nonsurgical, prescription treatment that helps promote healing in fractured bones. 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.

Model: 5314RCM

How the PhysioStim Device Works
To enhance bone healing of a nonunion fracture, PEMF therapy activates and augments the body’s natural healing process that may be impaired in some people.

The PhysioStim device contains a Control Unit and a Treatment Coil in one integrated device. A micro-processor generates the PhysioStim 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 PhysioStim PEMF signal is delivered through clothing and skin directly to the fracture site.

To learn more about bone growth stimulation, please visit our patient website at www.BoneGrowthTherapy.com.

Device Life
PhysioStim devices provide daily treatments for up to 365 days. The physician determines the overall length of treatment (months/weeks) on an individual basis according to fracture healing progress.

Device Operation

Turning the Device On and Off

The PhysioStim 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 treated days since the first use, and the compliance percentage.
The LCD will show the prescribed treatment time remaining and the battery status while treating.
The flashing colon on the LCD screen and On/Off button indicate that the device is on and delivering treatment.

The PhysioStim 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 PhysioStim device should be worn for 3 hours each day as prescribed by a physician.
• The PhysioStim 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 PhysioStim 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 PhysioStim 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 PhysioStim 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 PhysioStim 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 PhysioStim 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.
   Be sure to align the angled corners of the power supply connector to the angled corners of the connector inside the control unit.

3. Plug the power supply into any standard AC Wall Outlet. Do not plug in the power supply for the PhysioStim 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 alarms are designed to provide helpful information to the user. The chart below shows the various displays and alarms and their meaning.

Device Application

PhysioStim Device Models 5302CM and 5303CM
PhysioStim device models that are “U-shaped” are specifically designed for placement on a limb (e.g., tibia, femur, radius). These models may be worn over clothing, bracing, or over a cast or external fixation device if present. Proper treatment does not require direct contact with the body. However the coils must be centered around the fracture site to be effective. User can gently bend and shape the treatment coils to fit more comfortably around the body.

To apply

1. Begin with the PhysioStim device strap undone on one side.
2. Place the PhysioStim device so that it is centered over the treatment site. It is suggested that the skin or cast (if present) be marked to facilitate placement of the device.
3. Bring the strap around the limb and fasten.
4. If strap adjustment is needed, tighten or loosen the strap until it feels secure and comfortable. Remove the device for adjustment if needed.
5. The Sure Fit Cushion, which comes with models 5302CM and 5303CM, may also be placed on the interior of the coils to allow for a more secure and comfortable fit. The Sure Fit Cushion may be trimmed to further customize fit and comfort.
   

PhysioStim Device Model 5313CM
PhysioStim device model 5313CM may be placed on the collarbone (clavicle) or larger limb such as the thigh (femur). Model 5313CM may be worn over clothing, bracing or over a cast or external fixation device if present. Proper treatment does not require direct contact with the body. However the coils must be centered around the fracture site to be effective. User can gently bend and shape the treatment coils to fit more comfortably around the body.

*The PhysioStim device model 5313CM comes from manufacturing configured for clavicle placement. If being placed on a larger limb such as the thigh (femur), an accessory strap is available to ensure a comfortable fit.

To Apply

1. Fasten one end of the elastic strap to the end opposite the control unit using the plastic slide buckle (triple bar).
2. Place the PhysioStim device so that it is centered over the treatment site (either left or right collarbone). The control unit should be in front and visible.
3. Bring the elastic strap around the body under the opposite arm or limb and fasten to the end adjacent to the control unit.
4. If strap adjustment is needed, remove the device and tighten or loosen the strap until it feels secure and comfortable.
5. To adjust the strap length, use the square plastic slide buckle.
6. To loosen or tighten the strap, use the Velcro.

PhysioStim Device Models 5314LCM and 5314RCM
PhysioStim device models 5314LCM or 5314RCM are intended for placement on either the left or right shoulder (proximal humerus). Proper treatment does not require direct contact with the body. However the coils must be centered around the fracture site to be effective. User can gently bend and shape the treatment coils to fit more comfortably around the body.

To Apply

1. Fasten one end of the elastic strap to the end opposite the control unit.
2. Place the PhysioStim device so that it is centered over the treatment site (left or right shoulder). The control unit should be in front and visible.
3. Bring the elastic strap around the body under the opposite arm and fasten on the end of the device next to the control unit.
4. To adjust the strap length, use the square plastic slide buckle.
5. To loosen or tighten the strap, use the Velcro

PhysioStim Device Model 5315CM

PhysioStim device model 5315CM is intended for placement on the hip (proximal femur). Proper treatment does not require direct contact with the body. However the coils must be centered around the fracture site to be effective. User can gently bend and shape the treatment coils to fit more comfortably around the body.

*PhysioStim device model 5315CM comes from manufacturing configured for a right hip (proximal femur). To configure the device for a left hip (proximal femur), unthread the strap from the triple bar. Once the strap is detached from the device, rethread the strap through the opposite side of the device and back through the triple bar. Proceed to step 1 under ‘to apply’ below.

To Apply

1. Fasten one end of the elastic strap to the device.
2. Place the PhysioStim device so that it is centered over the affected hip (left or right).
3. Bring the elastic strap around the body and fasten on the opposite end of the device.
4. To adjust the strap length, use the square plastic slide buckle.
5. To loosen or tighten the strap, use the Velcro.

Device Accessories

All PhysioStim device models have removable/replaceable straps if needed from wear
and tear or sizing. Please contact Patient Services for assistance.
The PhysioStim device models 5302CM and 5303CM come with Sure Fit Cushion as an accessory for fit and comfort. If a replacement is needed, please contact Patient Services for assistance.

Device Use and Care

• The PhysioStim device is for single patient use.

• The PhysioStim device is a technologically advanced electronic device and should be handled with care. Dropping or other mishandling of the PhysioStim device may damage the device and it may stop working.

• For safe usage, follow manufacturer instructions when using PhysioStim 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 PhysioStim 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 PhysioStim 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 PhysioStim device.
• DO NOT expose the PhysioStim device to excessive moisture.
• DO NOT use solvents or alcohol-based liquids (anti-bacterial cleaners, hand sanitizers, perfume, etc.) to clean the PhysioStim device.

Storage and Operating Environments
When moving the PhysioStim 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 PhysioStim 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 PhysioStim 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 PhysioStim device instruction manual should be taken with you to quickly and easily identify the device for security personnel. Do not wear or operate the PhysioStim 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 PhysioStim device is for single patient use.

The PhysioStim 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 PhysioStim 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

Pulsed electromagnetic field (PEMF) osteogenesis stimulation is a safe, nonsurgical, prescription treatment to heal nonunion fractures and promote spinal fusion.
Electrical currents have been used to heal bones since the mid -1800s. However, it wasn’t until the 1950s that scientists made an important discovery. When human bone is bent or broken, it generates an electrical field. This low-level electrical field activates the body’s own repair mechanism which, in turn, stimulates bone healing.
Orthofix PEMF osteogenesis stimulators generate a uniform, low-level, pulsed electromagnetic field similar to the electrical field generated by the body. The application of PEMF directly to the fracture site helps activate and augment the body’s natural healing process to enhance bone fusion. Thank you for including Orthofix in your healing process. To learn more about osteogenesis stimulation, please visit our website at www.BoneGrowthTherapy.com.

Clinical Success of the PhysioStim Device

The PhysioStim device has been proven safe and effective in clinical studies. In a prospective, multicenter, controlled clinical study for nonunion fractures, an overall success rate of 80% was demonstrated among 126 patients (135 nonunion fractures) who averaged 3 or greater hours of daily treatment. The average duration of nonunion in these difficult fractures was 2.6 years, with an average of two prior surgical procedures per fracture. The success rate of the PhysioStim device treatment for nonunion repair demonstrated no statistically significant change over long-term (four year) follow-up.

Equipment Classification and Device Symbol Descriptions

PhysioStim Device Classifications

• Product Family Name: Orthofix PEMF Device
• Internally powered equipment.
• 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 12.5mm 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:

Compliance Statements
This device complies with Industry Canada license-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 operation 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 environment.
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

PhysioStim devices comply with IEC 60601-1-2 for electromagnetic compatibility (EMC). The PhysioStim 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 PhysioStim device. These types of equipment should be kept at least 0.198 m(7.8 in) away from the PhysioStim device.
The PhysioStim device has not been evaluated with regard to use with specific implantable electronic medical devices. Please consult your physician prior to use of the PhysioStim device with implantable electronic medical devices.

Warranty

Orthofix Inc. warrants the PhysioStim 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.

Orthofix
3451 Plano Parkway
Lewisville, Texas 75056-9453
USA
Tel 214-937-2718
Patient Services
800-535-4492 toll free

Orthofix.com
BoneGrowthTherapy.com
P/N 20123490 Rev. AE 2023-06-09
PS-2305 © 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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