Regenesis Reprieve 60 User manual
Reprieve 60
Compliance and Compatibility Assessment (CCA) device
Regenesis Medical Customer Service
1-877-970-4970
Save this manual for future reference.
Instruction Manual
Regenesis (1-877-970-4970) 2
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
Regenesis (1-877-970-4970) 3
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: 1-877-970-4970
Website: www.regenesismed.com
Email: support@regenesismed.com
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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.
Regenesis (1-877-970-4970) 9
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
5
6
2
1
7
2
3
Regenesis (1-877-970-4970) 11
Instructions for Use: SETUP
•Read Contraindications, Warnings, and Precautions sections before
using.
•Unbox the device and check for damage or missing parts.
•Choose a stable location for the device with easy access to Control
Panel.
•Ensure cables are not a tripping hazard.
WARNING: Choking and Strangulation Hazard –Keep the device
and cables out of the reach of children and pets.
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Instructions for Use: PREPARE DEVICE
•Plug in A/C Power Supply and Cable.
•The indicator light will flash blue, and the following message will
appear on the LCD screen:
You MUST read the contraindications, warnings, and precautions
before proceeding.
•Press any button to proceed.
Regenesis (1-877-970-4970) 13
Instructions for Use: PREPARE FOR TREATMENT
•Find a comfortable position with easy access to the treatment site.
•Remove all jewelry, watches, hearings aids, or metallic items that are
on the area to be treated before use
•To turn on the device from sleep mode press the POWER button:
•The LCD screen will display "Ready to Start Treatment," a countdown
of remaining treatment days, and a solid blue indicator light.
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Instructions for Use: POSITION TREATMENT APPLICATOR PAD(S)
•Position the Treatment Applicator Pad(s) on the treatment site(s).
oUse the Treatment Pad Positioning Guide for assistance.
oEnsure the Treatment Applicator Pad(s) are separated from any
metallic surface with padding.
oEnsure the dark colored side of the Treatment Applicator Pad(s)
are facing the area being treated.
•Apply only one Treatment Applicator Pad to the specific area you
are treating.
•Treatments can be given through clothing or dressings without
removing them.
CAUTION: Do not apply Treatment Applicator Pad directly to
breached or compromised skin (i.e., open wound, surgical
incision).
The dark colored side of the
Treatment Applicator Pad(s)
should be facing the area
you are treating.
Regenesis (1-877-970-4970) 15
Instructions for Use: START TREATMENT
•Press "Start Treatment" ( ) on the Ready to Start Treatment Screen
and listen for a beep.
•Look for the flashing green indicator light, Countdown Timer, and
active buttons (Power Off, Pause Treatment, and Speaker Volume)
during treatment.
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Instructions for Use: PAUSE or END TREATMENT
•Pause Treatment
oPress "Pause Treatment" ( ) to temporarily halt the treatment.
▪The indicator light will be solid blue and you will have 10
minutes to resume treatment.
▪A "Pause Remaining”Timer will display on the LCD screen.
oTo resume treatment, press "Resume Treatment" ( ) before
the 10-minute countdown finishes.
•End Treatment
oIf you need to end the session early, press "Power Off”( ) and
confirm with "YES" to stop the treatment.
oTreatment ends automatically when the prescribed time is up.
oThe device will enter sleep mode (LCD screen turns off).
oTo fully power down the device, unplug the A/C Power Cable
after the LCD screen turns off.
Regenesis (1-877-970-4970) 17
Cleaning and Storage
•Cleaning:
oDO NOT SUBMERGE this device in water or other liquids.
oBefore cleaning, unplug the device from the electrical outlet.
oThe device can be cleaned using a damp cloth moistened with
70% rubbing alcohol, as needed.
•Storage:
oStore the device in its original box.
oDo not expose to extreme temperatures or humidity beyond the
specified ranges:
•During treatment:
▪Temperature: 41º–104ºF (5º–40ºC)
▪Humidity: 15%–90%, non-condensing
▪Atmospheric Pressure: 700–1060 hPa/mbar
•While transporting or storing:
▪Temperature: -13º–158ºF (-25º–70ºC)
▪Humidity: 15%–90%, non-condensing
Regenesis (1-877-970-4970) 18
Troubleshooting
•Do not attempt to disassemble, service, or repair this device.
oCall Regenesis Medical Customer Service at 1-877-970-4970 for
assistance.
oIf your problem involves a health issue and you need
emergency assistance, please call 911 and/or contact your health
care professional.
•If device does not start and/or there are no indicator lights:
oMake sure the A/C Power Supply is firmly plugged into both:
▪The electrical wall outlet
▪The Base Unit
oIf the problem persists, call Regenesis Medical Customer Service
at 1-877-970-4970.
•If you see “SERVICE REQUIRED” message:
oPlease call Regenesis Medical Customer Service at 1-877-970-
4970.
•If device interferes with other electronic devices:
oMove the devices further apart,
oUntangle cables,
oPlug the device into a different outlet.
•USB port is not powered and is used for manufacturing purposes
only.
For further troubleshooting assistance, call:
Regenesis Medical Customer Service
1-877-970-4970
IMPORTANT: Please have the Serial Number, located on the label on the
back of the Base Unit, ready for Customer Service.
Regenesis (1-877-970-4970) 19
Returning Device
•If there are no treatment days left, the device will not activate. Follow
the return instructions provided in the Patient Treatment Information
Folder or contact Regenesis Medical to return the device.
Regenesis (1-877-970-4970) 20
Electromagnetic Compatibility (EMC) User Information
•Radiofrequency communications equipment may affect Reprieve.
•Keep portable communications equipment at least 30 cm (12 in) away
from any part of Reprieve to prevent performance degradation.
•Only use Regenesis Medical-specified accessories and cables with
Reprieve to avoid improper operation and increased electromagnetic
emissions.
•Avoid using Reprieve adjacent to or stacked with other equipment.
NOTE: The EMC tables and other guidelines that are included in the Instruction
Manual provide information 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.
Guidance and manufacturer’s declaration Electromagnetic Emissions
The REPRIEVE BY REGENESIS DEVICE is intended for use in the electromagnetic
environment specified below. The customer or the user of the REGENESIS REPRIEVE
DEVICE should assure that it is used in such an environment.
Emissions Test
Compliance
The REPRIEVE BY REGENESIS DEVICE must
emit electromagnetic energy in order to
perform its intended function. Nearby
electronic equipment may be affected.
RF emissions –CISPR 11
Group 2
RF emissions –CISPR 11
Class B
Harmonic emissions –IEC
61000-3-2
Class B
Voltage Fluctuations/
Flicker emissions –IEC
61000-3-3
Complies
The REPRIEVE BY REGENESIS DEVICE is suitable for use in all establishments including
those directly connected to the public low-voltage power supply networks which
supplies buildings used for domestic purposes, but not near active HF SURGICAL
EQUIPMENT or MAGNETIC RESONANCE IMAGING EQUIPMENT.
Guidance and manufacturer’s declaration Electromagnetic Immunity
The REPRIEVE BY REGENESIS DEVICE is intended for use in the electromagnetic
environment specified below. The customer or the user of the REPRIEVE BY REGENESIS
DEVICE should assure that it is used in such an environment.
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