Orthofix Physio-Stim Instruction Manual

INSTRUCTION MANUAL

Inside Front Cover

English version

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Table of Contents

Physio-Stim®
Instruction Manual

Prescription Information ...............................................................................1

Orthofix PEMF Stimulation ..........................................................................2

Clinical Success of the Physio-Stim .................................................................2

Device Description .......................................................................................3

Treatment Instructions ..................................................................................4

Device Operation .........................................................................................4

Turning the Device On and Off ................................................................4

Timing of Treatment Sessions ...................................................................5

Charging/Recharging the Battery ..............................................................5

Visual and Audio Indicators ...........................................................................6

Device Application .......................................................................................7

Models 3202 and 3303 ...............................................................................7

Model 3313............................................................................................................8

Models 3314L and 3314R .........................................................................9

Model 3315 ............................................................................................10

Equipment Classification and Device Symbol Descriptions ............................11

Care and Cleaning ......................................................................................12

Travel .......................................................................................................12

Storage .......................................................................................................12

Disposal .....................................................................................................12

Service .......................................................................................................12

Warranty Policy............................................................................................13

Package Contents:
1- Physio-Stim Osteogenesis Stimulator
1- Literature Pack
1- Power Supply
1- Line Cord

THIS DEVICE IS NONSTERILE.
IT DOES NOT REQUIRE STERILIZATION.

U.S. Patent No. 5,743,844

1

Prescription Information

Indication

The Physio-Stim® 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
Physio-Stim 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.

2

Orthofix PEMF Stimulation

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.bonestimulation.com.

Clinical Success of the Physio-Stim

The Physio-Stim 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 Physio-Stim treatment for nonunion repair demonstrated no statistically
significant change over long-term (four year) follow-up.

3

Device Description

The Physio-Stim is an external, low-level, PEMF device and has been designed
with patient comfort and convenience in mind. It is a single-piece device that
is lightweight, flexible and portable, allowing freedom of movement during
treatment. A Liquid Crystal Display (LCD) and audible alarm provide
important feedback during treatment such as the operational status, treatment
time remaining, battery capacity, etc. See “Visual and Audio Indicators” for
more information.

The Physio-Stim is comprised of a control unit and treatment transducer.
The control unit contains a micro-processor that generates the Physio-Stim
electrical signal. That signal is converted to a highly uniform, low-energy
magnetic field by the treatment transducer. When the device is centered
over the treatment area, the therapeutic Physio-Stim PEMF signal is delivered
directly to the treatment site.

The Physio-Stim is powered by a rechargeable lithium-ion battery pack.
The LCD and audible alarm will alert the patient when the battery is low and
needs to be recharged. See “Charging/Recharging the Battery” for more
information. To ensure that the device is functioning properly, the Physio-Stim
constantly monitors battery voltage and the electrical signal. If at any time
during treatment the device stops functioning properly, the LCD will display
an appropriate symbol or error code. See “Visual and Audio Indicators” for
more information.

Model: 3313

Control Unit

Treatment

Transducer

Adjustable Strap

4

Treatment Instructions

The Physio-Stim should be worn for three hours per day. Based upon clinical
data for nonunion, the overall treatment duration ranges between 90 and 180
days based upon specific patient conditions. At the end of the daily treatment
the device will turn itself off. The Physio-Stim may be used at any time of day
that is most convenient and comfortable for the patient. It is lightweight and
adjustable. And because the Physio-Stim is portable, treatment can be
received while the patient is sitting, walking, reclining, sleeping, etc. However,
since each patient is unique, the overall activity level should be based on
physician instructions.

Device Operation

Turning the Device On and Off

The Physio-Stim is turned on and off by pressing the On/Off button on the
control unit of the device. When the device is on, a sequence of status
messages will display momentarily. The LCD should then show the treatment
time remaining and a flashing Orthofix logo. The flashing logo indicates that the
device is on and functioning normally. (If you do not see this on the display,
contact Orthofix Customer Service.) A backlight button is on the control unit.
In low light, press the backlight button for illumination of the LCD.

Control Unit

LCD

Flashing

Orthofix Logo

Infrared Port

(IR Port)

On/Off Button

Backlight Button

Timing of Treatment Sessions

The Physio-Stim automatically times each treatment session. The timing begins
when the device is turned on. The LCD shows a countdown of the time
remaining in the treatment session. At the end of daily treatment, the device
will turn itself off. To stop treatment prior to the end of a treatment session,
simply press the On/Off button. To resume treatment, press the On/Off
button again. The LCD will display the remaining treatment time.

Note: For the countdown to function correctly, treatment sessions
should be greater than 60 minutes duration.

Charging/Recharging the Battery

The Physio-Stim is powered by a rechargeable lithium-ion battery pack.
A power supply is provided with the device. Use only the Orthofix charging
system to charge the battery. Note: The Physio-Stim battery will require
charging prior to the first use.

5

To charge/recharge the battery, simply plug the barrel connector end of the
power supply into the charger port located on the control unit. Plug the line
cord securely into the power supply. Plug the line cord into any standard AC
wall outlet. A fully discharged battery may require up to 4 hours to charge
completely.

The Physio-Stim battery can be recharged at any time the device is not in use.

It is strongly recommended that the device be recharged after
completing daily treatment.
Note: The Physio-Stim will not deliver treatment while charging.

When the device is on, the Physio-Stim LCD will show a battery capacity
symbol. A flashing battery outline, the symbol and an audible beep
indicate a battery low condition and that the battery needs to be charged.
See “Visual and Audio Indicators” for more information.

LCD

On/Off Button

Control Unit

Power Supply

Line Cord

Charger Port

IR Port

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.

Physio-Stim LCD Visual and Audio Indicators

Symbol /Alarm Description Meaning

All LCD symbols visible and
continuous audible alarm for
approximately 5 seconds

Countdown timer displays
remaining treatment time
(hours & minutes)

Orthofix logo flashes

Countdown timer
displays three dashes

audible alarm (5 beeps)

Steady symbol
for approximately 5 seconds

Symbols flash / audible alarm
(approximately 1 beep
per second)

Steady symbol indicates
approximate % of charge

Symbol filling repeatedly
indicates charge mode

Continuous audible alarm

Display of any E code
(e.g., E01, E02 . . .)

Power-on self test

Normal treatment
in progress

No treatment time
remaining

Treatment complete
— power off

Battery low —
recharge required

Battery status —
remaining charge
or charging mode

Device locked —
call for service

Error message —
call for service

7

Device Application

Models 3202 and 3303

Physio-Stim 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,
or over a cast or external fixation device if present.

To apply

1. Begin with the Physio-Stim unbuckled.

2. Place the Physio-Stim 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 elastic strap around the limb
and fasten the clasp.

4. If strap adjustment is needed, remove
the device and tighten or loosen
the strap until it feels secure and
comfortable.

8

Model 3313

Physio-Stim Model 3313 may be placed on the collarbone (clavicle) or larger
limb such as the thigh (femur). Model 3313 may be worn over clothing, or
over a cast or external fixation device if present.

To apply on a collarbone

1. Fasten one end of the elastic strap to the end opposite the control unit.

2. Place the Physio-Stim 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 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.

To apply on a limb

1. Use the short strap provided and attach to the device. Fasten one end
of the elastic strap to either end of the device.

2. Place the Physio-Stim so that it is centered over the treatment site. Gently
bend the device in a U-shape around the limb. It is suggested that the skin
or cast (if present) be marked to facilitate placement of the device.

3. Bring the elastic strap around the limb and fasten the clasp.

4. If strap adjustment is needed, remove the device and tighten or loosen the
strap until it feels secure and comfortable.