OMRON Tens Therapy Pain Relief Instruction Manual

June 7, 2024
Omron

OMRON

OMRON Tens Therapy Pain Relief

product

INTENDED USE:

The Omron TENS devices with heat are intended for: The relief of pain associated with sore or aching, muscles of the lower back, arms, legs, shoulder, or foot due to strain from exercise or normal household work activities.
Environments of Use: Clinics, hospital and home environments
Patient Population: Adult

INTRODUCTION

Please read this instruction manual thoroughly before using the gels.
The gel refills are only compatible with the Omron TENS devices with heat. The gels are placed onto the Omron TENS devices with heat cord with pads and are intended for use as a reusable, conductive adhesive gel between the patient’s skin and the electrical stimulator. Together, the pad with gels should be applied on normal, healthy, dry, clean skin of adults only.
Recommended Use: 3 sessions per day, 30 minutes per session maximum, sessions should not be consecutive

IMPORTANT SAFETY INFORMATION

CONSULT the Omron TENS devices with heat instruction manual for additional information.
CONTRAINDICATION: Do not use this device if you have a cardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic device. Such use could cause electric shock, burns, electrical interference, or death.

WARNING:

  • DO NOT apply the pads over your neck because this may cause severe muscle spasms resulting in closure of your airway, difficulty in breathing, or adverse effects on heart rhythm or blood pressure.
  • DO NOT apply the pads across your chest because the introduction of electrical current into the chest may cause rhythm disturbances to your heart, which could be lethal.
  • DO NOT apply the pads over open wounds or rashes or over swollen, red, infected or inflamed areas or skin eruptions (such as varicose veins, phlebitis, thrombophlebitis and thrombosis), or on top of or close to cancerous lesions, or over areas of skin that lack normal sensation. Any area of pain with swelling or inflammation, the condition may worsen.
  • DO NOT apply the pads on persons incapable of expressing their thoughts or intentions.
  • DO NOT apply the pads on persons who are unable to operate the unit by themselves.
  • DO NOT apply when bathing, showering, sleeping, during exercise, or while sweating.
  • DO NOT apply the pads while driving, operating machinery or during any activity in which electrical stimulation can put you at risk of injury.
  • DO NOT apply the pads on infants, toddlers, or children because this device has not been evaluated for pediatric use.
  • DO NOT apply the pads on pregnant women.
  • Use the pads carefully to avoid serious burns.
  • DO NOT use over sensitive skin areas or in the presence of poor circulation.
  • DO NOT use this device under a blanket or under any other heated devices.
  • If your pain does not improve, becomes more than mild, or continues for more than 5 days, stop using the device and consult with your physician.
  • If the device is too hot, stop using it immediately.

CAUTION: Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury to the user or patient or cause damage to the equipment or other property.

  • The long-term effects of electrical stimulation are unknown.
  • Do not apply the pads incorrectly or by using excessive pressure, because discomfort or skin burns may occur.
  • Use caution if stimulation is applied over areas of skin that lack normal sensation.
  • Since the effects of stimulation of the brain are unknown, stimulation should not be applied across your head and electrodes should not be placed on opposite sides of your head.
  • Do not use on wet skin (from sweating, bathing, high humidity).

ADVERSE REACTIONS:

  • You may experience skin irritation and burns beneath the stimulation electrodes applied to your skin.
  • You may experience headache and other painful sensations during or following the application of electrical stimulation near your eyes and to your head and face.

HOW TO USE THE GELS

Reminder:

  • The cord with pads do not work correctly without the gels. For safety and effectiveness, they must be used together.
  • Before use, inspect the cord with pads for open wires or any damage. If damaged, do not use and replace immediately because it could cause skin burns or fire.
  • Clean and dry affected area so it is free of all lotions/oils/sweat. The pads with gels should be applied only to normal, intact, clean, healthy skin.
  1. Remove gels from sealed plastic container.
  2. Peel off the thin plastic film that is blank.
  3. Place this sticky gel side over the black rectangular area of the cord with pad.
  4. Make sure the gels lay evenly and securely with no bubbles, bending or missing pieces. Check for damage and check the adhesion before each therapy session.
  5. Next, peel off the other thin plastic film that says “SKIN”.
  6. Place the remaining sticky gel side around the area of pain at least 1 inch apart (Do not let them touch). Place the pads with gels onto normal, clean, dry healthy skin that is not experiencing any swelling or inflammation.

Note:

  • The size, shape and type of pads may affect the safety and effectiveness of electrical stimulation.
  • The electrical performance characteristics of pads may affect the safety and effectiveness of electircal stimulation.
  • Do not share the same gels with another person because of the risks of adverse skin reactions and to prevent the spread of disease.
  • Do not use gels after Exp. date.

WHEN TO REPLACE THE GELS

If the gel no longer sticks firmly to your skin, or if more than 25 % of the gel is not in contact with your skin, replace the gel. (The cord with pads is permanent, do not discard). DO NOT CLEAN THE GELS. DISCARD AND REPLACE WITH A NEW GELS.

  • Try not to bend or fold the gels and cord with pads during therapy or while storing.
  • In between uses, keep the gels and cord with pads together and place the sticky side down onto either side of the plastic pad holder.
  • Wrap the cord around the plastic pad holder.
  • With proper storage and use, you may extend the life of gels to 30 uses. The life of the gels may vary due to skin condition and storage condition.
  • Operating conditions:+50 °F to +104 °F (+10 °C to +40 °C), 30 to 80 % RH (non-condensing), 700 to 1060 hPa
  • Storage conditions:+32 °F to +104 °F (0 °C to +40 °C), 30 to 80 % RH (non-condensing)
  • Transportation conditions:-4 °F to +140 °F (-20 °C to +60 °C), 10 to 95 % RH
  • With proper storage and use, you may extend the life of your pads.

KEEP OUT OF REACH OF INFANTS, TODDLERS, OR CHILDREN Symbols Glossary

For symbol information,
visit: OmronHealthcare.ca/symbols-glossary
Questions? 1-800-634-4350
Manufactured for: OMRON HEALTHCARE, Co., Ltd. 53, Kunotsubo, Terado-cho, Muko, Kyoto, 617-0002 JAPAN

Distributed by: OMRON HEALTHCARE, INC.
1925 West Field Court
Lake Forest, IL 60045 U.S.A.
OmronHealthcare.ca
©2019 OMRON HEALTHCARE, INC.
Made in Japan. Packaged in China.

OMRON

References

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