Physio Stim Orthofix 5302 User manual

Instruction Manual
Models: 5302, 5303, 5313, 5314L, 5314R, 5315

PhysioStim Device Patent No.
5743844
6132362
Assembled in the United States of America
ASSEMBLED IN
USA

PhysioStim™ Device Instruction Manual
Table of Contents
Prescription Information ................................................................................1
• Indication................................................................................................1
• Contraindication .....................................................................................1
• Warnings.................................................................................................1
• Precautions .............................................................................................1
• Adverse Effects........................................................................................1
Device Description..........................................................................................2
• How the PhysioStim Device Works..........................................................2
• Device Life...............................................................................................2
Device Operation............................................................................................3
• Turning the Device On and Off................................................................3
• Treatment Instructions ............................................................................4
• Timing of Treatment Sessions .................................................................4
• Charging the Battery............................................................................4-5
• Visual and Audio Indicators ....................................................................6
Device Application ....................................................................................7-11
Device Accessories........................................................................................12
Device Use and Care ....................................................................................12
• Care and Cleaning.................................................................................12
• Storage .................................................................................................13
• Travel.....................................................................................................13
• Disposal.................................................................................................13
• Service...................................................................................................14
Clinical Information......................................................................................14
Clinical Success of the PhysioStim Device.....................................................14
Equipment Classification and Device Symbol Descriptions...........................15
PhysioStim Device Classifications .................................................................16
Compliance Statements ...............................................................................16
Information Regarding Electromagnetic Compatibility and Immunity .........17
Device Box Components
1 – PhysioStim Device
1 – Device Strap
1 – Power Supply
1 – Literature Pack
1 – Sure Fit Cushion (Models 5302 and 5303)
Orthofix Patient Services: 800-535-4492 or 214-937-2718
To learn more about Orthofix, please visit our website at www.orthofix.com.

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.
1

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: 5314
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.
2
Control Unit
Treatment
Transducer Adjustable
Strap

1:59
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.
3
Control Unit
Charging
Port
LCD
Treatment
Indicator
On/Off
Button

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), or 20123808).
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
4

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.
5
Angled Corners
AC Power Supply
AC Charging Connector
Charging Port Cover

6
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.
Compliance Screen
170/185 = 91.9%
Treatment Screen
1:59 Treatment Screen – displays the treatment time remaining
in hours and minutes. The timer counts down to zero until
daily treatment is complete.
Exception Screen
E123 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.
Low Battery Warning Screen
1:59 Low Battery – Displays along with three fast beeps when
recharging is recommended.
Charging Complete
Charging Complete – Indicates when the battery is
fully charged.
Battery must be charged
to turn on
E12345678
E12345678
Battery Empty – Indicates that the battery must be
charged before treatment may continue.
Device Expired
Device Expired – Display of a closed lock indicates the
device has been available for treatment for 365 days
and will no longer provide a treatment.
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.
Charging Screen
Battery Charging – Battery symbol filling repeatedly verifies
that the device is charging.
Treatment Complete
Daily Prescribed Treatment complete
1-800-535-4492

Device Application
PhysioStim Device Models 5302 and 5303
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.
7

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 5302 and 5303, 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.
8

PhysioStim Device Model 5313
PhysioStim device model 5313 may be placed on the collarbone (clavicle) or
larger limb such as the thigh (femur). Model 5313 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 5313 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.
9

10
PhysioStim Device Models 5314L and 5314R
PhysioStim device models 5314L or 5314R 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 5315
PhysioStim device model 5315 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 5315 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.
11

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.
In addition, 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 5302 and 5303 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.
12

Storage
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 III 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.
13

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.
14

15
Equipment Classification and Device Symbol Descriptions
Symbol Meaning Symbol Location
Read Instructions for Use
Attention – Refer to Instruction Manual Device and Device Box
Type BF Applied Part Device and Device Box
On/Off Device
Prescription Only Device
Storage Temperature Range Device Box
Date 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
Atmospheric Pressure Limitations Device Box
EU Authorized Representative Instruction Manual
REF
Catalog Number Device and Device Box
SN
Serial Number Device and Device Box
RCM - Regulatory Compliance Mark
(Australia) Device

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:
Orthofix # 20110412: Orthofix # 20114794:
Input: 100-240VAC, 50-60Hz, 200mA Input: 100-240VAC, 50-60Hz, 150-350mA
Output Voltage: 5VDC, 1.3A Output Voltage: 5VDC, 2.4A
Orthofix#: WR9QA1200U23KIT(R6B): Orthofix#: 20123808:
Input: 100-240VAC, 50-60Hz, 0.6A Input: 100-240VAC, 50-60Hz, 0.6-0.3A
Output Voltage: 5VDC, 1.2A Output Voltage: 5VDC, 1.2A
Compliance Statements
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 device must accept any interference received, including
interference that may cause undesired operation.
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. These limits
are designed to provide reasonable protection against harmful interference
in a residential installation. This equipment generates, uses and can radiate
radio frequency energy and, if not installed and used 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.
16

17
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.