Regenesis Reprieve 60 User manual

Reprieve 60
Compliance and Compatibility Assessment (CCA) device
Regenesis Medical Customer Service
1-877-970-4970
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Instruction Manual

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Table of Contents
Introduction
3
About Shortwave Diathermy
4
Glossary and Symbol Definitions
5
Indications and Contraindications for Use
6
Warnings and Precautions
7
Potential Adverse Reactions
8
General Usage and Safety Guidelines
9
Product Description
10
Instructions for Use
SETUP
11
PREPARE DEVICE
12
PREPARE FOR TREATMENT
13
POSITION TREATMENT APPLICATOR PAD(S)
14
START TREATMENT
15
PAUSE or END TREATMENT
16
Cleaning and Storage
17
Troubleshooting
18
Returning Device
19
Electromagnetic Compatibility (EMC) User Information
20
System Technical Specifications
23

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Introduction
The Reprieve 60 by Regenesis is a home-use shortwave diathermy device
designed to relieve pain and alleviate muscle spasms.
Please read this entire instruction manual carefully before using this
device.
The Reprieve 60 device assesses compliance and compatibility with
Reprieve therapy and is active for 60 days from the first time you plug
the device in.
You will be notified of the remaining number of active days on the
Reprieve 60 device. At the end of the 60-day assessment period, contact
Regenesis Medical to return the device.
If you have any questions, please contact Regenesis Medical:
Phone: [phone]
Website: www.regenesismed.com
Email: [e-mail]

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About Shortwave Diathermy
Shortwave diathermy (SWD) uses electromagnetic energy to produce a
thermal effect in tissues. The Reprieve 60 by Regenesis™device can
operate in continuous or pulsed wave modes with varying power levels.
As the pulsed mode has lower average power, potential hazards typically
associated with the continuous wave mode may not apply.
Transmission Profile
Continuous Wave
Pulsed Wave
Pulse Duration
N/A (Continuous)
20, 40, 60, 80, and 100
microseconds
Pulse Frequency
N/A (Continuous)
200, 400, 600, 800, and
1000 Hz
Duty Cycle
100%
0.4% to 10%
Signal Strength
9W
0.3 W to 7.0 W

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Glossary and Symbol Definitions
•Contraindications: Conditions under which the device should not be
used as the risk of use outweighs potential benefit (e.g., reasons not
to use this device).
•EMC: Electromagnetic Compatibility –the ability of the Reprieve
device to operate effectively in the presence of other electronic
devices.
Precaution: Hazard that may result in minor to moderate injury
to the user or damage to the equipment or other property
Warning: Hazard that may lead to death or serious injury
There are important operating, maintenance and service
instructions in the literature accompanying the product.
The presence of uninsulated dangerous voltage within the
product’s enclosure may be of sufficient magnitude to constitute
a risk of electric shock.
This device intentionally applies electromagnetic energy for
medical treatment.
This device is a Type BF applied part. The Treatment Applicator
Pads are safe to place against a living body.
This device is Magnetic Resonance (MR) unsafe –keep away
from magnetic resonance imaging (MRI) equipment
IP21
This device carries an Ingress Protection (IP) Rating of 21 –is
protected from touch by fingers or similar objects and from
water spray less than 15 degrees from vertical.

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Indications and Contraindications for Use
Indications for Use
•The Reprieve 60 by Regenesis™device (Reprieve) is indicated to
generate deep heating within body tissues for the treatment of
conditions such as relief of pain and muscle spasms.
•Reprieve is intended for adults only (22 years of age and older).
Contraindications
•NEVER use Reprieve if you:
oAre pregnant
oHave a blood clotting disorder
oHave impaired cognition (an inability to comprehend how to
use device or follow instructions for use)
•NEVER use Reprieve over the following locations or conditions:
oActive implanted deep brain stimulators, spinal cord
stimulators, and cardiac pacemakers
oActive cancer
oDeveloping fetus
oDeveloping gonads
oActive inflammation or infection
oMetal implants, not including metal screws, rods, and plates
▪e.g., it is safe to treat over metal screws, rods, and plates
If your prescribing clinician is not aware of the any of the above
contraindications, call your clinician to discuss your situation before using
this device.

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Warnings and Precautions
WARNING: Choking and Strangulation Hazard –Keep the device
and cables out of the reach of children and pets.
WARNING: Consult your physician if the intended area of
treatment is a prior cancer site.
WARNING: Do not administer more than one treatment every
two hours. Exceeding the recommended time limits can result in
tissue becoming overheated and damaged.
WARNING: Do not use this device:
•Unless you are the prescribed user.
•If the cable(s), power supply, and/or Treatment Applicator
Pad(s) are damaged.
oInspect regularly for possible damage.
•In the presence of flammable anesthetic mixtures or in
oxygen rich environments.
CAUTION: When using over the following areas or conditions:
•Breached or compromised skin (i.e., open wound, surgical
incision)
•The ocular and orbital regions (eye area)
•The head or neck
•Poorly vascularized tissue(s)
•Areas of thermal insensitivity
•Areas of impaired sensation
•Implanted metal lead wires
•Noncopper, metallic intrauterine devices (IUDs)

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Potential Adverse Reactions
•Shortwave diathermy applied to the lower back in women can result
in increased menstrual flow during menses.
•Consistent and vigorous heating can result in edema of the skin,
subcutaneous fat, and muscle tissue.
Discontinue device use and consult a physician or qualified individual if
adverse effects occur.

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General Usage and Safety Guidelines
Federal law restricts this device to sale by, or on the order of, a licensed
health care practitioner.
Follow these guidelines for the safe and effective use of Reprieve:
•The therapy administrator should not be within 3 inches of the
treatment area for more than 6 minutes.
•Any persons with a pacemaker should not be within 6 inches of the
treatment area.
•Follow your clinician's instructions for best results.
•Do not use an alternate A/C power supply other than the one
supplied by Regenesis Medical (P/N 315-2000-00).
•Remove all jewelry, watches, hearing aids, or metallic items that are
on the area to be treated before use.
•Treatments can be given through clothing or dressings without
removing them.
oNever treat over wet skin or clothing.
•Do not stand on Treatment Applicator Pad(s).
•Do not submerge this device in water or other liquids.
•Do not use this device while driving.
•Keep this device away from other electronic devices. If this is not
possible, monitor nearby devices to avoid interference. Take these
steps to avoid disrupting other medical equipment:
oKeep the Treatment Applicator Pad(s) away from other
electronics or cables,
oMove the devices further apart,
oUntangle cables,
oPlug the device into a different outlet.

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Product Description
1
Base Unit
5
LCD Screen
2
Treatment Applicator Pads
6
Control Panel
3
Applicator Cables
7
Indicator Light
4
A/C Power Supply (not pictured)
If any items are missing or appear damaged,
Contact Regenesis Medical Customer Service
1-877-970-4970
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