INTENDED USERS Proactive-Elle is ideal for the treatment of painful period camps. It is non-invasive and drug-free. Proactive-Elle should be used only by women 16 years old and above. PRINCIPAL OF OPERATION Proactive-Elle is a TENS (Transcutaneous Electrical Nerve Stimulator) device, which works as a pain treatment system.
Page 5
ADDITIONAL BENEFITS OF PROACTIVE-ELLE • Proactive-Elle relieves menstrual pain and discomfort. • Proactive-Elle increases feelings of well-being. • Proactive-Elle allows you to carry out your daily activities. • Proactive-Elle is easy to apply and to use. • Proactive-Elle is a compact pocket-sized device that you can carry in your handbag when not in use and wear comfortably under your clothes as needed.
SAFETY INFORMATION TENS is a symptomatic treatment that suppresses the sensation of pain. It has no curative value and is not effective on pain that is of central origin including headaches. Contraindications Do not use in the following situations: • Undiagnosed pain syndromes (until etiology is established) •...
Page 7
• Do not apply stimulation while driving, operating machinery, or during any activity when electrical stimulation can put you at risk of injury. • Batteries are rechargeable; batteries should not be replaced by unauthorized personnel. • Keep Proactive-Elle dry. Do not expose the device to a wet environment.
Page 8
• Turn Proactive-Elle off before applying or removing gel pad. • Only use with Proactive-Elle gel pad. • Long-term stimulation at the same site may cause skin irritation. Use only as advised by a healthcare professional. • You may experience skin irritation or hypersensitivity due to the electrical stimulation or electrical conductive material (silica gel).
Page 11
Once treatment is completed, press the [on/off] button for 5 seconds to turn off the device. Indicator light: red light indicates low power and your Proactive-Elle needs to be charged as soon as possible. When your device is charged, the light is blue and ready for use.
GETTING STARTED - USING PROACTIVE-ELLE Proactive-Elle is as simple to use as it is comforting. Follow these easy steps to get started: • Prior to first use, charge your Proactive-Elle device for approximately 12 hours. • Turn on Proactive-Elle and adjust to the treatment level that is comfortable and start benefiting from soothing pain relief.
Page 13
If gel pad seems to have lost its adhesive properties, replace with a new Proactive-Elle gel pad. • Use only gel pad supplied with the device or supplied by an authorized Proactive distributor or purchased at: ® www.proactive-painmanagement.com...
Page 14
Carefully read the contraindications and safety information in this manual before using your device for the first time. In the center of the front panel of Proactive-Elle is the power button, which is easily operated by a light touch of the finger.
When charging is completed, the LED light will be blue. Disconnect the USB cable and store it for future use. It is recommended to charge your Proactive-Elle for approximately 12 hours prior to first use. Caution •...
• If gel pad seems to have lost its adhesiveness, replace with a new Proactive-Elle gel pad. STORAGE • Fully charge the battery before long-term storage and charge it every 2-3 months to extend the life of the battery.
Page 17
BASIC TROUBLESHOOTING GUIDE PROBLEM CAUSE SOLUTION Press the button The intensity level is not until stimulation properly adjusted. is felt. Gel pad is not Attach the gel pad firmly attached to the firmly to the skin. skin. Can’t feel any The adhesive surface of Replace it with a new stimulation...
Troubleshooting Guide (continued) PROBLEM CAUSE SOLUTION Stimulation stopped The battery is low. Charge the battery. unexpectedly The adhesive surface Clean the adhesive of the gel pad is dirty surface of the gel pad or dusty. with a slightly damp Gel pad won’t lint-free cloth, or stay firmly replace the gel pad.
SYMBOLS The following table describes the symbols that appear on the system, its components, and packaging. SYMBOL MEANING Serial number Reference number Date of manufacture Manufacturer Refer to instruction manual Dispose of in accordance with EC Regulations on Waste Electrical and Electronic Equipment (WEEE) BF-type applied part.
ELECTROMAGNETIC COMPATIBILITY With the increased number of electronic devices such as PC and mobile (cellular) telephones, radio transceivers, mobile radio transmitters, radio-controlled toys, and so on, medical devices in use may be susceptible to electromagnetic interference from other device. Electromagnetic interference may result in incorrect operation of the medical devices and create a potentially unsafe situation.
Page 21
Emmission Test Compliance Electromagnetic Environment - Guidance RF emissions Group 1 The Proactive-Elle uses RF energy only CISPR 11 for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
Page 22
Guidance and manufacturer’s declaration – electromagnetic immunity The Proactive-Elle is intended for use in the electromagnetic environment specified below. The customer or the user of the Proactive-Elle should assure that it is used in such an environment. Immunity test IEC 60601 test...
Page 23
Guidance and manufacturer’s declaration – electromagnetic immunity The Proactive-Elle is intended for use in the electromagnetic environment specified below. The customer or the user of the Proactive-Elle should assure that it is used in such an environment. Immunity test IEC 60601...
Page 24
Proactive-Elle is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of Proactive-Elle can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the...
LIMITED WARRANTY A.M.G. Medical Inc. warrants the TENS device to be free from defects in material and workmanship for a period of one (1) year, to be proven by means of the sales receipt or invoice. This warranty is valid for the original purchaser only. Any alterations, abuse, misuse or accidental damage voids this warranty.
Page 28
Questions? Comments? 1-800-363-2381 • www.proactive-painmanagement.com Made and printed in China for / Fabriqué et imprimé en Chine pour : A.M.G. Medical Inc. 8505 Dalton, Montréal, QC H4T 1V5 Canada • 1-800-363-2381 Distributed in the USA by / Distribué aux É.-U par : AMG Medical, Inc.
Need help?
Do you have a question about the Elle 715-432 and is the answer not in the manual?
Questions and answers