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Regenesis Reprieve Instruction Manual

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Reprieve by Regenesis
®
Reprieve DUO by Regenesis
™
Instruction Manual
Regenesis Medical Customer Service
1-877-970-4970
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  • Page 1 Reprieve by Regenesis ® Reprieve DUO by Regenesis ™ Instruction Manual Regenesis Medical Customer Service 1-877-970-4970 Save this manual for future reference...

  • Page 2: Table Of Contents

    Instructions for Use SETUP PREPARE DEVICE PREPARE DEVICE (First time use) UNLOCK DEVICE PREPARE FOR TREATMENT POSITION TREATMENT APPLICATOR PAD(S) START TREATMENT PAUSE or END TREATMENT Cleaning, Storage, and Disposal Troubleshooting Electromagnetic Compatibility (EMC) User Information System Technical Specifications Regenesis (1-877-970-4970)

  • Page 3: Introduction

    Introduction The Reprieve by Regenesis® and Reprieve DUO by Regenesis ™ (Reprieve) are home-use shortwave diathermy devices designed to relieve pain and alleviate muscle spasms. Please read this entire instruction manual carefully before using this device. These devices are designed for use by the individual to whom it is prescribed.

  • Page 4: About Shortwave Diathermy

    About Shortwave Diathermy Shortwave diathermy (SWD) uses electromagnetic energy to produce a thermal effect in tissues. The Reprieve 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.

  • Page 5: 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.

  • Page 6: Indications And Contraindications For Use

    The Reprieve 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: •...

  • Page 7: Warnings And Precautions

    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) • Regenesis (1-877-970-4970)
  • Page 8 Non-rechargeable batteries are not to be recharged. • Do not force discharge, recharge, disassemble, heat • above (manufacturer’s specified temperature rating) or incinerate. Doing so may result in injury due to venting, leakage, or explosion resulting in chemical burns. Regenesis (1-877-970-4970)

  • Page 9: Potential Adverse Reactions

    • 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)

  • Page 10: 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 •...

  • Page 11: Product Description

    5 Fingerprint Sensor 2 Treatment Applicator Pads 6 LCD Screen 3 Applicator Cables 7 Control Panel 4 A/C Power Supply (not 8 Indicator Light pictured) If any items are missing or appear damaged, Contact Regenesis Medical Customer Service 1-877-970-4970 Regenesis (1-877-970-4970)
  • Page 12 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. Regenesis (1-877-970-4970)
  • Page 13 Instructions for Use: PREPARE DEVICE First, firmly plug in A/C Power Supply Cable into the back of the • Reprieve device gripping the plastic barrel. Next, plug the A/C Power Supply Cable into a standard electrical • outlet. The following message will display on the LCD screen and the •...
  • Page 14 You MUST read the contraindications, warnings, and precautions before proceeding. Press any button to proceed. • If this is your first-time using Reprieve, continue to page 15. If this is NOT your first-time using Reprieve, continue to page 18. Regenesis (1-877-970-4970)

  • Page 15: Instructions For Use

    Note: For your security, actual fingerprints are not scanned nor stored in the Reprieve device. Electronic reference templates are created and stored using the unique pattern of a fingerprint (see below) to assure that only the authorized user is able to use the Reprieve device. Fingerprint Key features Template ...
  • Page 16 When all 3 scans are accepted the LCD screen will display “First finger setup complete” and the indicator light will be solid green. 4. Press lower left button to continue. 5. Repeat steps 1-4 above with a second and third finger. Regenesis (1-877-970-4970)
  • Page 17 Instructions for Use: PREPARE DEVICE When all three fingers are registered the LCD screen will display • “Fingerprint Setup Complete, Your Reprieve device is now ready for use.” and the indicator light will be solid green. Press the lower left button ( ) to proceed.
  • Page 18 Instructions for Use: UNLOCK DEVICE After a treatment is completed, the Reprieve device will enter • sleep mode if left plugged in. If the device is in sleep mode, press any button to turn on the device and start treatment. Your fingerprint will not be required.
  • Page 19 • items on the area to be treated. To turn on the device from sleep mode press any button. • The LCD screen will display "Ready to Start Treatment” and the • indicator light will be solid blue. Regenesis (1-877-970-4970)
  • Page 20 Apply only one Treatment Applicator Pad to the specific area(s) 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). Regenesis (1-877-970-4970)
  • Page 21 ) on the lower left of the Ready to Start • Treatment Screen and listen for a beep. During treatment the LCD screen will display a Countdown Timer • and active buttons (Power Off, Pause Treatment, and Speaker Volume) and the indicator light will flash green. Regenesis (1-877-970-4970)
  • Page 22 "YES" to stop the treatment. Treatment ends automatically when the prescribed time is up. The device will enter sleep mode (LCD screen turns off). To fully power down the device, unplug the A/C Power Cable after the LCD screen turns off. Regenesis (1-877-970-4970)

  • Page 23: Cleaning, Storage, And Disposal

    ▪ 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 ▪ Disposal: • Please contact Regenesis Medical at 1-877-970-4970 for proper disposal of your Reprieve device. Regenesis (1-877-970-4970)

  • Page 24: Troubleshooting

    23 and retry. Power cycle the device by unplugging the device from the wall outlet and re-plugging it in. If the problem persists, call Regenesis Medical Customer Service at 1-877-970-4970. If device does not start and/or there are no indicator lights: •...
  • Page 25 Troubleshooting If you see “SERVICE REQUIRED” message: • Please call Regenesis Medical Customer Service at 1-877-970- 4970. If device interferes with other electronic devices: • Move the devices further apart. Untangle cables. Plug the device into a different outlet. USB port is not powered and is used for manufacturing purposes •...

  • Page 26: Electromagnetic Compatibility (Emc) User Information

    Reprieve to prevent performance degradation. Only use Regenesis Medical-specified accessories and cables with • Reprieve as it could result in increased electromagnetic emissions or decreased immunity of the Reprieve device and could result in improper operation.
  • Page 27 Electromagnetic Compatibility (EMC) User Information 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 REPRIEVE BY REGENESIS DEVICE should assure that it is used in such an ®...
  • Page 28 ESSENTIAL dip in U ) for dip in U ) for PERFORMANCE, if the 25 cycles 25 cycles user of the REPRIEVE BY 0% U (100% 0% U (100% REGENESIS DEVICE dip in U ) for dip in U...
  • Page 29 0,15 MHz to 0,15 MHz to equipment should be 80 MHz 80 MHz used no closer to any 6 Vrms 6 Vrms part of the REPRIEVE BY 0,15 MHz to 0,15 MHz to REGENESIS DEVICE, ® 80 MHz 80 MHz...
  • Page 30 To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the REPRIEVE BY REGENESIS ® DEVICE is used exceeds the applicable RF compliance level above, the REPRIEVE BY REGENESIS DEVICE should be observed to verify normal operation.
  • Page 31 Electromagnetic Compatibility (EMC) User Information Recommended separation distances between portable and mobile RF communications equipment and the REPRIEVE BY REGENESIS DEVICE ® The REPRIEVE BY REGENESIS DEVICE is intended for use in an electromagnetic ® environment in which radiated RF disturbances are controlled. The customer or...

  • Page 32: System Technical Specifications

    System Technical Specifications OVERVIEW The Reprieve by Regenesis® is a shortwave diathermy device designed to operate at the Federal Communications Commission authorized medical device frequency of 27.12 MHz. During treatment, the device transmits a fixed dose of electromagnetic energy via one or two applicator pads that are placed adjacent to the area to be treated.
  • Page 33 Effective Radiated 9W using a 50- 0.3 to 7.0W using a 50-ohm Power ohm matched matched load* load* * Effective radiated power derived using peak to peak voltage measured with oscilloscope into a 50- ohm RF load termination. Regenesis (1-877-970-4970)
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  • Page 35 [This page intentionally left blank] Regenesis (1-877-970-4970)
  • Page 36 5301 North Pima Road Scottsdale, AZ 85250 Website: www.regenesismed.com Email: support@regenesismed.com Phone: 1-877-970-4970 250-2000-00 B Regenesis (1-877-970-4970)

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