Regenesis Biomedical Provant Infinity User manual

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Infinity
Instruction Manual
Toll-Free Customer Service
1-877-970-4970
Save this manual for future reference

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Introduction 3
Indications for Use 4
Contraindications 4
Warnings and Precautions 4
Advisories 5
Product Description 6
General Information 7
Instructions for Use 8
Setting Up 8
Preparing to Administer a Treatment Session 8
Starting a Treatment Session 9
Pausing or Interrupting a Treatment Session 10
Finishing Treatment 10
Cleaning 11
Moving and Storage 11
Troubleshooting 12
Servicing 13
Symbol Definitions 13
Summary of Clinical Performance 14
Electromagnetic Compatibility (EMC) User Information 15
System Technical Specifications 19
Copyright 2021 Regenesis Biomedical, Inc. All rights reserved. Regenesis, Regenesis Biomedical, the Energy Starburst logo, and
the Provant Infinity trade name and logo are registered trademarks of Regenesis Biomedical, Inc., Scottsdale, AZ.
Introduction
Table of Contents
This Instruction Manual is intended to assist you in using Provant
Infinity. This device is a pulsed electromagnetic field (PEMF) device
that is indicated for adjunctive use in the palliative treatment of
postoperative pain and edema of soft tissue. Pain and edema (i.e.,
swelling) can be significant obstacles to postoperative recovery. By
helping reduce post-operative/post-procedural pain and swelling,
Provant Infinity plays an important role in your care. Please read this
entire instruction manual carefully before using this device. If you
have any questions, please contact Regenesis Biomedical:
Phone: [phone]
Website: www.regenesisbio.com
Email: [e-mail]

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Indications for Use
Warnings and Precautions
Contraindications
(Reasons not to use this device)
The Provant Infinity is indicated for the adjunctive use (as part of
another therapy) in the palliative treatment of postoperative pain
and edema of soft tissue.
• DO NOT USE this device over implanted metal lead wires.
Closely follow any directions published by the implanted device
manufacturer’s instructions for use (IFU).
• DO NOT USE this device if you are using another electronic medical
device without first contacting your physician.
• The effect of this device on prescription medicated patches has not
been evaluated. Please contact your physician prior to use over a
prescription medicated patch.
• The effect of this device on cancer, either solid or blood-related,
and precancerous lesions, is not known.
• In a limited number of cases, patients have reported pain
(hyperalgesia) with use of this device.
• The long-term health effects of this device are not known.
• The long-term biologic effects of exposure to this device beyond
the manufacturer’s recommended dosing are not known.
• If you have a pacemaker or defibrillator.
• If you are or may be pregnant.
• If you are under 22 years of age (i.e., over bony growth areas in children).
• If you intend to use this device over your active or previously
treated cancer, either solid or blood-related in origin.

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• CAUTION: If your prescribing clinician is not aware of the
contraindications, warnings or precautions, call your clinician to
discuss your situation before using this device.
• CAUTION: Strangulation Hazard – Keep the device and cables out
of the reach of children.
• DO NOT USE this device if it has damaged cable(s), damaged
power supply or Treatment Applicator Pad.
• DO NOT USE an alternate A/C Power Supply other than one
supplied by Regenesis Biomedical (P/N 315-1005-01).
• DO NOT USE this device in the presence of flammable anesthetic
mixtures.
• DO NOT USE this device in oxygen-rich environments.
• DO NOT SUBMERGE this device in water or other liquids.
• DO NOT dispose of the Provant Infinity device. Please contact
Regenesis Biomedical at 1-877-490-4970 to return the device.
• This nonthermal shortwave therapy (SWT) device generates PEMF
energy to produce clinical effects. Placing this device near other
electronic devices while it is operating is not recommended. If
this is unavoidable, nearby devices should be carefully observed
to ensure that electromagnetic interference does not degrade
performance. To avoid or alleviate disturbances to other medical
equipment, follow the recommendations below:
• Ensure that the active side of the Treatment Applicator Pad
is not near or pointing toward other electronic devices or
cabling while in operation.
• Reorient or relocate the other electronic device(s).
• Increase the separation between the Treatment Applicator
Pad and other electronic device(s).
• Reposition cables so that they are not on or near each other.
• Connect the equipment into an outlet on a circuit that is
different than the other electronic device(s).
Advisories

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Product Description
1) Base Unit
2) Treatment Applicator Pad
3) Control Panel
4) Applicator Cable
5) A/C Power Supply
6) A/C Power Cable
7) POWER Button
8) Treatment Button
9) LCD Screen
10) Indicator LED
11) Carrying case (not pictured)
If any items are missing or appear damaged, please contact
Regenesis Biomedical at 1-877-970-4970
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General Information
• Provant Infinity must be prescribed by a licensed healthcare
professional.
• This device is intended to be used solely by the patient for whom it
is prescribed.
• If you are not sure of the treatment areas or the number of
treatments, please contact your prescribing clinician.
• Provant Infinity has SAFE-T-Energetics™ (self-adjusting
feedback technology). Provant Infinity automatically regulates and
controls the delivered dose, adjusting to meet each patient’s
unique body characteristics.
• In order to achieve desired results, it is recommended to treat
twice a day, about 8 to 12 hours apart, for the full pre-timed
30-minute treatment; however, it is important to treat as your
prescribing clinician has directed.
• Treatments are pre-timed and can be administered through
clothing, dressings, etc. There is no need to remove these items for
treatment.
• DO NOT stand on the treatment applicator pad.
• Provant Infinity is an electrical device; access to a three-prong
electric outlet is required for use. Use the A/C power supply
provided with this device.
• By following the instructions in this manual, you can administer
your own treatments. Alternatively, a family member or care
provider may administer the treatments.
• Please contact Regenesis Biomedical at 1-877-970-4970 for proper
disposal your Provant Infinity device.
• Please keep the original shipping box for storing, transporting
or shipment for any future repair or upgrade.

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Instructions for Use
1. SETTING UP
1a. Read Safety Information on pages 4 and 5 before
using this device.
1b. Remove device from carrying case.
1c. Check all device components for damage and if any
items are missing or appear damaged, contact
Regenesis Biomedical at 1-877-970-4970.
1d. Choose a location for your treatment and place the Base Unit
of the device in a convenient, stable location (e.g., side table,
floor, etc.). Make sure you can see and reach the Control
Panel before you start treating.
1e. Make sure that the Applicator Cable and A/C Power Supply
cables are:
• Not wrapped around each other.
• Not positioned to possibly trip someone who is walking
through the treatment area during your treatment.
2. PREPARING TO ADMINISTER A TREATMENT SESSION
2a. TURNING ON DEVICE
• Plug in the A/C Power Supply into the back of the base unit
and the A/C Power Cable into an adjacent, easy to reach,
three-prong electrical outlet.
• The indicator light will flash as the device initializes.
A beep will sound, and the indicator light will be green
when the device is ready to proceed with starting a
treatment.
• If the POWER button ( ) is on but the LCD screen and
indicator light are dark, the device is on in sleep mode.
Turn the device on by pressing the POWER button.
The device will then proceed to active mode and is ready
to start a treatment when:
o The POWER button is illuminated
o The bottom left and top right buttons are illuminated
o The LCD screen is on
o The indicator light is green

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2b. POSITIONING THE TREATMENT APPLICATOR PAD
• Find a comfortable position sitting or lying down.
o If you are sitting or lying on a metallic surface, make sure
comfortable padding (e.g., a mattress or cushion) is
between the Treatment Applicator Pad and the metal, so
as not to interfere with the delivery of the therapeutic
PEMF energy.
o Make sure you are positioned such that the area to be
treated is easily reached.
• Position the Treatment Applicator Pad directly against the
treatment area.
o Apply Treatment Applicator Pad to the specific area you
are treating. Always aim the white side with the
STARBURST towards the treatment area.
o It is not necessary to remove any light clothing or
dressings as PEMF energy penetrates from the Treatment
Applicator Pad through clothing and dressings.
o DO NOT apply Treatment Applicator Pad directly to
breached or compromised skin (i.e. open wound, surgical
incision).
3. STARTING A TREATMENT SESSION
3a. Press the “Start Treatment” button (lower left) on the
Control Panel.
3b. Look for the following indicators:
• The indicator light will flash green, letting you know that
treatment has begun.
• Three buttons will illuminate on the Control Panel during
treatment: the“Power Off” button (upper left), the “Pause”
button (upper right), and the “Stop Treatment” button
(lower left).
• The Countdown Timer on the LCD screen will tell you how
much time remains in the treatment session.

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4. PAUSING OR INTERRUPTING A TREATMENT SESSION
4a. Pause treatment: Press “Pause” button on the Control Panel.
• The indicator light will flash orange.
• A 20-minute Pause Remaining Timer will display on the
top center of the LCD screen, indicating how much time is
left for the treatment to be paused. After 20 minutes the
device will shut down.
4b. Resume treatment: Press the “Resume” button to continue
treatment session before the Pause Remaining countdown
time is complete.
• You can stop treatment early if you will not be able to finish
the treatment session or are directed to treat for a shorter
duration by your clinician.
4c. Stop treatment: Press the “Stop Treatment” button or
“Power Off” button on the Control Panel.
• Press YES or NO to complete confirmation to Stop Treatment.
• When the Stop Treatment action is used the device will
shut down.
5. FINISHING TREATMENT
5a. At the end of 30 minutes, treatment will automatically end.
5b. Do not immediately unplug the device. Prior to completely
powering down and entering sleep mode, the device will
proceed through a shutdown process. The device will indicate
sleep mode.
5c. If you wish to fully power down the device, unplug the A/C
Power Cable from the electrical outlet after the shutdown
process has completed.

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Cleaning
Moving and Storage
• DO NOT SUBMERGE this device in water or other liquids.
• Before cleaning, unplug the device from the electrical outlet.
• Provant Infinity can be cleaned using a damp cloth moistened with
70% rubbing alcohol. Do not use cleaning products containing
bleach.
IMPORTANT: To avoid damage, properly pack the device and
A/C Power supply in the carrying case.
• Unplug the A/C Power Supply from the wall and from the Base Unit.
Bundle and place in the space next to the opening for the Base Unit.
• Place the Base Unit into its location in the carrying case.
• Place the Treatment Applicator Pad in its location in the carrying case,
positioning the cables above the A/C Power Supply. DO NOT
wrap cable around the Treatment Applicator Pad.
• Close up carrying case.
• Carry the device using the convenient carrying handle on the
carrying case.
• Please store the device at room temperature.
• This device should not be exposed to extreme environmental
conditions outside of the following ranges for more than 24 hours:
o Operating your system (when using during a treatment session)
• Temperature: 54º–90ºF (12º–32ºC)
• Humidity: 15%–90%, non-condensing
o Storing or Transporting your system
• Temperature: -4º–122ºF (-20º–50ºC)
• Humidity: 15%–90%, non-condensing
o Operating Atmospheric Pressure: 700–1060 hPa/mbar

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Troubleshooting
This section will help you troubleshoot common problems.
DO NOT attempt to disassemble, service, or repair this device.
Call Regenesis Biomedical at 1-877-970-4970 for additional assistance.
If your problem involves a health issue and you need emergency
assistance, please call 911 and/or contact your health care professional.
DEVICE DOES NOT START AND/OR THERE ARE NO INDICATOR LIGHTS:
• Make sure the A/C Power Cable is firmly plugged into the A/C
Power Supply
• Make sure the A/C Power Supply is firmly plugged into the
three-pronged electrical wall outlet.
• Make sure the A/C Power Supply is firmly plugged into the Base Unit.
• Make sure the A/C Power Supply indicator light is on.
• Do not use an alternate A/C Power Supply. If A/C Power Supply is
required, replace with Regenesis A/C Power Supply P/N 315-1005-01.
• If the problem persists, call Regenesis Biomedical at 1-877-970-4970.
SERVICE REQUIRED MESSAGE:
• Please call Regenesis Biomedical at 1-877-970-4970.
DEVICE APPEARS TO INTERFERE WITH OPERATION OF OTHER
ELECTRONIC DEVICES:
• Make sure the Treatment Applicator Pad is not near other electronic
devices or their cables.
• Make sure the A/C Power Supply and Applicator Cable are not near
other electronic devices or their cables.
• Plug the device into a different three-pronged electrical
wall receptacle.
• Increase the distance between the Treatment Applicator Pad and
the other electronic devices.
• Move other electronic devices to a place where there is
no interference.
For further troubleshooting assistance, call:
Regenesis Biomedical
1-877-970-4970
IMPORTANT:
Please have the Serial Number ready for Customer Service.
It is located on the label on the back of the unit.

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Servicing
Symbol Definitions
• DO NOT attempt to disassemble, service, or repair this device.
• Products not covered under the Limited Warranty may also require
repairs. Repairs outside of warranty will be charged for the retail
cost of parts, plus labor and shipping charges.
• Regenesis Biomedical recommends routine maintenance every
two years. For any maintenance related information, call Regenesis
Biomedical at 1-877-970-4970.
There are important operating, maintenance and service
instructions in the literature accompanying the product.
There is a presence of un-insulated “dangerous voltage”
within the product’s enclosure that may be of sufficient
magnitude to constitute a risk of electric shock.
This device intentionally applies pulsed electromagnetic
field (PEMF) energy to cells for medical treatment.
This device is a type BF applied part. This means the
Treatment Applicator Pad is safe to place against a living body.
This device is Magnetic Resonance (MR) unsafe – keep away
from magnetic resonance imaging (MRI) equipment
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Summary of Clinical Performance
The clinical performance of Provant has been evaluated in a number of
post-operative conditions including lumbar surgery, total knee arthroplasty,
and bunionectomy. These studies point out the safe use of Provant and while
the studies were not powered, trends were observed to be consistent with the
indication of pain and edema reduction of soft tissue.
Clinical Performance
Three randomized, blinded, sham-controlled studies have been conducted to
evaluate the clinical performance of Provant.
Study 1 evaluated subjects with chronic post-operative pain 3 to 36 months after
lumbar decompression surgery. Subjects were randomized to receive Provant
(N=13) or sham control (N=14) and treated twice daily for 60 days.
Study 2 evaluated subjects with chronic post-operative pain 3 to 36 months after
a total knee arthroplasty (TKA). Subjects were randomized to receive Provant
(N=24) or a sham control (N=11) and treated twice daily for 60 days.
Study 3 evaluated subjects with acute pain directly following bunionectomy
surgery. Subjects received treatment with the Provant device (N=71) or sham
control (N=68) for 7 days directly following surgery.
An additional open-label study in subjects (N=41) with chronic postoperative pain
after low back surgery was also conducted.
Safety of Provant
The safety of Provant has been evaluated in 225 subjects in controlled clinical
studies. The overall rate of adverse events with Provant was similar to a matched
sham control. Adverse events that occurred more with a higher frequency with
Provant was increased pain (hyperalgesia).
Regenesis Biomedical maintains a post-market surveillance program to monitor
the safety of Provant following prescription of the device. Regenesis has received
reports of adverse events of greater than 1 per 1000 patients in pain (hyperalgesia)
(2.3% of patients) and skin reaction (0.2% of patients). A subset of hyperalgesia
patients was instructed by their prescribers to temporarily discontinue Provant until
hyperalgesia improved, followed by reintroduction at a lower dose, with a gradual
dose increase over time, were able to tolerate Provant.
Reports received at a rate of 0.1% or less generally related to preexisting pain, the
underlying condition being treated, or to the surgical procedures that preceded
the use of Provant. Regenesis Biomedical does not consider these latter reports as
being associated with use of Provant.
Expected Adverse Events
Based on a survey where all patients treated with Provant were asked to report
any symptoms and signs, 2.3% reported increased pain and 0.2% reported rash
while using Provant. Infrequent reports of increased pain have also been reported
by patients in clinical trials.

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Electromagnetic Compatibility (EMC) User Information
WARNINGS:
• The emissions characteristics of this equipment make it suitable for
use in industrial areas and hospitals (CISPR 11 class A). If it is used
in a residential environment (for which CISPR 11 class B is normally
required) this equipment might not offer adequate protection
to radiofrequency communication services. The user might need
to take mitigation measures, such as relocating or reorienting the
equipment.
• The Provant Infinity has special precautions regarding EMC and
needs to be installed and put into service according to the EMC
information provided in this manual.
• Portable and mobile RF communications equipment can affect
Provant Infinity.
• The use of accessories, transducers and cables other than those
specified by Regenesis Biomedical could result in increased
electromagnetic emissions or decreased electromagnetic
immunity of the equipment and result in improper operation.
• This equipment should not be used adjacent to or stacked with
other equipment because it could result in improper operation.
If such use is necessary, this equipment and the other equipment
should be observed to verify that they are operating normally.
• Portable RF communications equipment (including peripherals
such as antenna cables and external antennas) should be used
no closer than 30 cm (12 inches) to any part of the Provant Infinity,
including cables specified by the manufacturer.
Otherwise, degradation of the performance of this equipment
could result.
NOTE: The EMC tables and other guidelines that are included in the Instruction
Manual provide information to the customer or user that is essential in
determining the suitability of the equipment or system for the electromagnetic
environment of use, and in managing the electromagnetic environment of use to
permit the equipment or system to perform its intended use without disturbing
other equipment and systems or non-medical electrical equipment.

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System Technical Specifications
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Infinity
Regenesis Biomedical, Inc
5301 N. Pima Road
Scottsdale, AZ 85250
Toll Free: [phone]
Fax: [phone]
Email: [e-mail]
www.regenesisbio.com
©Regenesis Biomedical 2021 250-0014-00 E
Protected under US patents, 6,334,069; 6,353,763; 6,967,281; 6,974,961; 7,024,239; 7,572,985 and 7,579,555. Additional
patents are pending. Provant, Regenesis, Regenesis Biomedical, SAFE-T-ENERGETICS, the Provant yellow, and the Energy
Starburst Logo are registered trademarks of Regenesis Biomedical, Inc., Scottsdale, AZ.