Related Manuals for Regenesis Reprieve 60
Summary of Contents for Regenesis Reprieve 60
- Page 1 Reprieve 60 Compliance and Compatibility Assessment (CCA) device Instruction Manual Regenesis Medical Customer Service 1-877-970-4970 Save this manual for future reference.
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Page 2: Table Of Contents
General Usage and Safety Guidelines Product Description Instructions for Use SETUP PREPARE DEVICE PREPARE FOR TREATMENT POSITION TREATMENT APPLICATOR PAD(S) START TREATMENT PAUSE or END TREATMENT Cleaning and Storage Troubleshooting Returning Device Electromagnetic Compatibility (EMC) User Information System Technical Specifications Regenesis (1-877-970-4970) -
Page 3: Introduction
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:... -
Page 4: About Shortwave Diathermy
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. -
Page 5: Glossary And Symbol Definitions
This device is Magnetic Resonance (MR) unsafe – keep away from magnetic resonance imaging (MRI) equipment This device carries an Ingress Protection (IP) Rating of 21 – is IP21 protected from touch by fingers or similar objects and from water spray less than 15 degrees from vertical. Regenesis (1-877-970-4970) -
Page 6: Indications And Contraindications For Use
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). -
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: 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 9: General Usage And Safety Guidelines
• 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. -
Page 10: Product Description
Product Description Base Unit LCD Screen Treatment Applicator Pads Control Panel Applicator Cables 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 Regenesis (1-877-970-4970) -
Page 11: Instructions For Use Setup
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 12: 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) -
Page 13: Prepare For Treatment
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. Regenesis (1-877-970-4970) -
Page 14: Position Treatment Applicator Pad(S)
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). Regenesis (1-877-970-4970) -
Page 15: 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. Regenesis (1-877-970-4970) -
Page 16: Pause Or End Treatment
"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 17: Cleaning And Storage
Do 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) -
Page 18: Troubleshooting
Make sure the A/C Power Supply is firmly plugged into both: The electrical wall outlet ▪ The Base Unit ▪ If the problem persists, call Regenesis Medical Customer Service at 1-877-970-4970. If you see “SERVICE REQUIRED” message: • Please call Regenesis Medical Customer Service at 1-877-970- 4970. -
Page 19: Returning Device
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) -
Page 20: Electromagnetic Compatibility (Emc) User Information
Flicker emissions – IEC 61000-3-3 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. - Page 21 ESSENTIAL PERFORMANCE: None other than that related to basic safety. 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.
- Page 22 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.
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Page 23: 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 24 5301 North Pima Road Scottsdale, AZ 85250 Website: www.regenesismed.com Email: support@regenesismed.com Phone: 1-877-970-4970 250-2000-60 C Regenesis (1-877-970-4970)
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