OMRON electroTHERAPY Pain Relief

Introduction

Thank you for purchasing OMRON's electroTHERAPY pain relief solution. To ensure safe and effective use, please read this complete manual carefully before using the device for the first time. Keep this instruction manual in a convenient place or store it with the device for future reference.

Register your product online at www.register-omron.com. Keep your purchase receipt as proof of purchase for warranty coverage.

The OMRON PM3030 electroTHERAPY pain relief solution is intended for the relief of pain associated with sore or aching muscles of the lower back, arms, or legs due to strain from exercise or normal household and work activities. It should be applied to normal, healthy, dry, clean skin of adult patients. This package contains the following components:

• Unit
• Electrode Cords
• 2 Self-Adhesive Pads
• Plastic Pad Holder
• Two AAA Batteries
• Instruction Manual
• Quick Start Guide with Pad Placement Guide

SAVE THESE INSTRUCTIONS

Important Safety Precautions and Warnings

It is important to read all warnings and precautions in this manual to ensure your safety, prevent injury, and avoid damage to the device.

Safety Symbols Used in This Instruction Manual

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

DANGER

This unit must not be used in combination with the following medical devices:

1. Internally transplanted electronic medical devices, such as a pacemaker.
2. Electronic life support equipment, such as respirators.
3. Electronic medical devices attached to the body, such as electrocardiographs.

Using this unit with other electronic medical devices may cause erroneous operation of those devices.

Do Not Use This Device Under These Conditions

• Consult with your physician before using this device, as it may cause lethal rhythm disturbances in certain susceptible individuals.
• 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.
• Together with a life-supporting medical electronic device such as an artificial heart or lung or respirator.
• In the presence of electronic monitoring equipment (e.g., cardiac monitors, ECG alarms), which may not operate properly when the electrical stimulation device is in use.
• On open wounds or rashes, or over swollen, red, infected, or inflamed areas or skin eruptions (e.g., phlebitis, thrombophlebitis, varicose veins); On top of, or in proximity to, cancerous lesions.
• Over areas of skin that lack normal sensation.
• On the opposite sides of your head, as the effects of stimulation of the brain are unknown.

Do Not Use On These Individuals

• Pregnant women, because the safety of electrical stimulation during pregnancy has not been established.
• Children or infants, because the device has not been evaluated for pediatric use.
• Persons incapable of expressing their thoughts or intentions.

Do Not Use This Device During These Activities

• When in the bath or shower.
• While sleeping.
• While driving, operating machinery, or during any activity in which electrical stimulation can put you at risk of injury.

Never Apply the Pads To:

• The head or any area of the face.
• The neck or any area of the throat, as this could cause severe muscle spasms resulting in closure of the airway, difficulty in breathing, or adverse effects on heart rhythm or blood pressure.
• Both sides of the thorax simultaneously (lateral or front and back), or across your chest, because the introduction of electrical current may cause rhythm disturbances which could be lethal.

Pain Management Warnings

• If you have had medical or physical treatment for your pain, consult with your physician before using this device.
• If your pain does not improve, becomes seriously chronic or severe, or continues for more than five days, stop using the device and consult with your physician.
• Pain itself is a warning that something is wrong. If you suffer from any serious illness, consult your physician to confirm it is advisable to use this electroTHERAPY unit.

Warnings and Precautions Regarding the Pads

• Apply pads to normal, healthy, dry, clean skin (of adult patients) as it may otherwise disrupt the healing process.
• If you experience any skin irritation or redness after a session, do not continue stimulation in that area of the skin.
• Do not bend or fold pads, as they may not function properly. Store on either side of the plastic pad holder when not in use.
• Do not apply ointment or any solvent to the pads or your skin, as it will disrupt the pads' function. The pads are pre-gelled and will adhere to your skin.
• To avoid damage to the adhesive surface, place pads only on the skin or on the plastic pad holder.
• Place pads at least 1 inch apart on your skin; they should never touch each other.
• Always place clean pads according to the provided illustrations (Refer to pages 16-18, Pad Placement).
• Ensure components are connected well and pads are fixed on the treatment area for effective therapy.

Do Not Use Your Pads This Way

• Pads should not touch each other when placed on your skin.
• Do not place on your spine or backbone.
• Pads should not touch any metal object, such as a belt buckle or necklace.
• Pads should not be placed simultaneously on the soles of both feet.
• Pads should not be placed simultaneously on the calves of both legs.
• Do not share pads with another person, as this may cause skin irritation or infection. Pads are intended for use by one person.
• Do not place or relocate the pads while the device is on. Always turn the power off before removing or changing the pad location.
• Do not leave pads attached to the skin after treatment.

Caution While Using Unit

• If the unit is not functioning properly or you feel discomfort, immediately stop using the device.
• Do not use for any other purpose except for what it is intended for.
• Do not insert the electrode plug into any place other than the jack on the main unit.
• Do not mix Alkaline and Manganese batteries, as this will shorten battery life.
• Do not pull on the electrode cord during treatment.
• Do not use the device while wearing electronic devices such as watches, as this may damage the device.
• Do not use near a cell phone, as this may cause the stimulator to malfunction.
• Do not bend or pull the end of the cord.
• When pulling out the cord, hold the plug and pull.
• Replace the cord when broken or damaged.
• Do not throw batteries into a fire; they may explode.
• Dispose of the device, batteries, and components according to applicable legal regulations to prevent environmental pollution.
• 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 electrical stimulation.
• Using pads that are too small or incorrectly applied could result in discomfort or skin burns.

General Precautions

• The long-term effects of electrical stimulation are unknown.
• Apply stimulation to only normal, intact, clean, dry, and healthy skin.
• TENS is not effective in treating the original source or cause of the pain, including headache.
• TENS is not a substitute for pain medications and other pain management therapies.
• TENS devices do not cure disease or injuries.
• TENS is a symptomatic treatment and suppresses the sensation of pain, which would otherwise serve as a protective mechanism.
• Effectiveness is highly dependent upon patient selection by a practitioner qualified in pain management.
• You may experience skin irritation or hypersensitivity due to electrical stimulation or the conductive medium (gel).
• If you have suspected or diagnosed heart disease, follow precautions recommended by your physician.
• If you have suspected or diagnosed epilepsy, follow precautions recommended by your physician.
• Use caution if you have a tendency to bleed internally, such as following an injury or fracture.
• Consult your physician prior to using the device after a recent surgical procedure, as stimulation may disrupt the healing process.
• Use caution if stimulation is applied over the menstruating or pregnant uterus.
• Use caution if stimulation is applied over areas of skin that lack normal sensation.
• Keep the unit away from young children. The unit contains small pieces that may be swallowed. Contact your physician immediately if swallowed.
• Use this device only with leads, electrodes, and accessories recommended by the manufacturer.
• Keep the unit out of the reach of young children. The electrode cord can cause strangulation.

Possible Adverse Reactions

• Do not use to treat one region for extended periods (more than 30 minutes per session, up to 3 times/day), as muscles may become exhausted and sore.
• You may experience skin irritation and burns beneath the stimulation electrodes.
• You may experience headache and other painful sensations during or following the application of electrical stimulation near your eyes, head, and face.
• You should stop using the device and consult with your physician if you experience adverse reactions.

How electroTHERAPY for Pain Relief Works

What is it?

The electroTHERAPY pain relief device is a 3-program, portable device designed for adults only. It is designed to reduce and relieve muscle and joint pain, stiffness, and numbness in the arms, legs, and foot by applying electrical nerve stimulation to the skin surface near the site of pain. It can be used in conjunction with any other pain treatment or medication. This therapy, called Transcutaneous Electrical Nerve Stimulator (TENS), has been used for over 30 years by medical professionals such as physical therapists and chiropractors.

How does it work?

Scientific theory suggests that electrical stimulation therapy may work in several ways:

1. The gentle electrical pulses move through the skin to nearby nerves to block or shut out the pain message from reaching the brain from the source of the pain.
2. The gentle electrical pulses increase the production of the body's natural pain killers, such as endorphins.
3. Electrical stimulation is thought to improve blood circulation. Muscles contract and relax with the flow of electrical stimulation, improving blood circulation.

Know Your Unit

Package Contents

The package contains:

• Unit
• Electrode Cords
• Two Pads (98mm x 64mm)
• Pad Holder
• Batteries for trial use (two AAA size (R03) batteries)
• Instruction Manual
• Quick Start Guide/Pad Placement Guide

Features

1. Three pre-set programs: Arm, Lower Back, Leg/Foot.
2. Five intensity levels of therapy, from low intensity 1 to high intensity 5.
3. A pair of pads (durable, reusable, washable, up to 150 uses). Do not use with non-manufacturer's pads or electrode cord.

Mode Indicator

The blinking light indicates the operation mode. The blinking pattern of the lights corresponds to the selected intensity level.

Buttons and Their Functions

• Electrode Cord Jack: Port for connecting the electrode cord.
• ON/OFF Power Button: Press to turn the unit on; low frequency therapy will start.
• Program Circle Button: Use to select your preferred therapy area and program (Arm, Lower Back, Leg/Foot).
• Intensity Setting Button: Set intensity to one of 5 levels. Press the UP arrow (▲) for higher intensity and the DOWN arrow (▼) for lower intensity.

Operating Instructions

Simple Assembly Steps

Step 1 – Insert Batteries

1. Remove the battery cover on the back of the unit.
2. Insert batteries, ensuring the (+) and (-) signs correspond correctly.
3. Reinstall the battery cover.

Notes:

• During battery replacement, replace both batteries with new ones.
• Dispose of used batteries according to local regulations.

Step 2 – Attach Electrode Cord to the Unit

Attach the clip of the electrode cord to the top and plug it into the main unit.

Step 3 – Attach Pads to the Electrode Cord

For first-time use, take the pads out of the sealed package and remove the clear plastic film from the back of the pad. Discard the plastic film backing and the clear packaging.

(In-between uses, turn the unit off and keep electrodes connected to pads. Place pads onto the sides of the plastic holder and wrap the cord around the holder. Store in a dry, cool location.)

Step 4 – Snap Either Electrode Cord to Each of the Pads

Easy Steps to Get Started With Your Therapy

Step 1 – Pad Placement (Use for a Maximum of 30 Minutes)

Place pads on clean, dry, and healthy skin near the area with pain, at least 1 inch apart. Do not let them touch. It is acceptable to place them near or surrounding the pain. Ensure there is a linear path between the two pads (refer to illustrations below or the Pad Placement Guide insert).

Before starting therapy, rate your pain from 1 (low) to 10 (high). This mental check provides a basis for comparison after the session.

Lower Back

Attach both pads on the lower back with the backbone in the center. Do not place on the backbone or spine.

Sciatic

Attach one pad below and above the region in pain, both on the same side (NOT on the spine).

Deltoid

Attach one pad in front and one in back of the muscle.

Upper Arm

Attach both pads on either side of the region where you feel pain.

Elbow

Attach both pads on either side of the joint with the pain.

Hip & Thigh

Attach both pads on either side of the area with pain.

Knee

Attach both pads above the knee or above and below the joint with pain.

Calf

Attach both pads on the calf/leg where you feel pain. Do not place electrode pads simultaneously to the calves of both legs.

Ankle/Foot

Attach pads per the illustration: on the left for pain on the outside of your ankle/foot; on the right for pain on the inside of your ankle/foot.

Step 2 – Select 1 of 3 Programs

Push the “ON” button. The default program will blink (the device defaults to the last program used at the lowest intensity level). Personalize your therapy by pushing the Program Circle Button to select a pre-set program: 1. Arm, 2. Lower Back, 3. Leg/Foot.

How do you switch programs?

Each time you push the orange circle button, it switches to the next program at the lowest intensity level. Depending on the program, you will feel a gentle combination of tapping, kneading, or pulsing sensations that vary in pulse speed.

How to select the right program

Select the program that feels right for your unique pain. The programs are interchangeable and may be used for more than one body part.

Step 3 – Select the Correct Intensity Level (1 Low – 5 High)

Start at the lowest intensity level and slowly increase it by pushing the green “UP” arrow button. You should feel a gentle pulsing sensation.

How do I pick the right intensity level for my pain?

Each time you push the green “up” or “down” arrow, it moves to another level. If the stimulation sensation becomes weaker or disappears, increase the intensity until it is restored. If the sensation is uncomfortable, press the down arrow to decrease the intensity.

• Press ▲ for higher intensity.
• Press ▼ for lower intensity.

What intensity level is my unit on?

The program's blinking light indicates the level you have selected. For example, 2 blinks means you are at level 2, 3 blinks means level 3, and so on. The number of blinks corresponds to the selected intensity level.

How to Control and Reduce Your Pain

When should the device be used?

Use as soon as your pain begins. Start with one session (the unit automatically turns off at 15 minutes). Turn off with pads still on and RATE YOUR PAIN again (1 low to 10 high).

Get to your pain early

If you address your pain early, it may prevent it from becoming worse or chronic. It is better to get it under control sooner so that it does not reach a high pain threshold that limits your daily activities.

How long should you use it?

Start with one 15-minute session. Always turn the unit off with pads still on. Rate your pain to check your progress (1 low to 10 high). Stop the therapy session if pain has reduced or stopped. Press the “On” button to continue therapy for another 15-minute session.

• 1 session: 15 minutes (automatic shut-off)
• Max minutes/session: 30 minutes or two sessions
• Max times/day: 3 times per day

(NOTE: Long-time treatment and strong stimulation may cause muscular fatigue and may generate adverse effects.)

When to stop using the device?

1. If you experienced an adverse reaction (skin irritation/redness/burns, headache or other painful sensation, or if you feel any unusual discomfort).
2. If your pain does not improve, becomes seriously chronic and severe, or continues for more than five days.

What type of pain is it best for?

This therapy works best on acute pain because it is localized. Acute pain is pain in one area for less than 3 months. If you have chronic pain, you may have pain in more than one area and for longer than 6 months. Chronic pain may be compounded by other issues that this device cannot address.

Remember, this device does not cure your pain or the original cause of the pain. It provides temporary relief or reduction of pain so that you can control your life and activities better.

Cleaning and Storage

Cleaning the pads

The unit is designed for repeated use over time. The pads will last up to 150 uses, or 5 months (based on use 1/day). Here are important cleaning and storage instructions:

1. Turn the power off and remove the electrode cord from the pads.
2. Wash the pads when the adhesive surface becomes dirty and/or the pads are difficult to attach. Wash the pad softly with your fingertips under slow running cold water for several seconds (do not use a sponge/cloth/sharp object like a nail on the adhesive side; do not use detergents, chemicals, or soap).
3. Pads can be washed after 15 uses, approximately ten times for up to 150 uses (do not wash the pads too long or too frequently).
4. Dry the pads and let the adhesive surface air-dry completely (do not wipe with a tissue paper or cloth).
5. Pads are replaceable and can be purchased by calling 1-800-634-4350 or visiting www.omronhealthcare.com.

The life of pads may vary by the frequency of washing, skin condition, and storage state.

When should you replace your pads?

If the pad no longer sticks to your skin or if more than 25% of the pad's surface is not in contact with your skin.

Cleaning the unit

1. Turn the unit off and disconnect the electrode cords from the pads.
2. Clean with a lightly moistened cloth (or a cloth soaked in a neutral cleaning solution) and wipe gently.
   • Do not use chemicals (like thinner, benzene).
   • Do not let water get into the internal area.

Storing the pads

1. Turn the unit off and remove the cord plug from the jack.
2. Remove the pads from your body.
3. Leave the electrode cords connected to the pads and place the pads on the pad holder (one on each side).
4. Wrap the electrode cords around the pad holder.

Storing the unit and pads

• Place the unit, pads with electrode cords on the pad holder, Pad Placement Guide, and Instruction Manual inside the original box.
• Do not keep in areas subject to direct sunlight, high or low temperatures, humid areas, near fire, vibration, or shock. Store in a cool, dry place (5°C - 40°C / 4°F - 104°F, 30% - 40% relative humidity).
• Do not keep at places that can be easily reached by children.
• When not in use for a long period, remove the batteries before storage to avoid liquid discharge from batteries.

Troubleshooting

If the above measures are not effective, contact OMRON at www.omronhealthcare.com.

Limited Warranty

Your electroTHERAPY pain relief unit and electrode cords are warranted for 1 year, and the pads are warranted for 30 days. They are guaranteed to be free from defects in materials and workmanship if used according to the instructions provided. These warranties extend only to the original retail purchaser. OMRON will, at its option, repair or replace, without charge, any device covered by these warranties. Repair or replacement is OMRON's sole responsibility and your only remedy.

To obtain warranty service, contact Customer Service by calling 1-800-634-4350 for the address of the repair location and return shipping and handling fee. Enclose the Proof of Purchase. Include a letter with your name, address, phone number, and a description of the specific problem. Pack the product carefully to prevent damage in transit. Because of possible loss in transit, OMRON recommends insuring the product with return receipt requested.

THE FOREGOING IS THE SOLE WARRANTY PROVIDED BY OMRON IN CONNECTION WITH THIS PRODUCT, AND OMRON HEREBY DISCLAIMS ANY OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. IMPLIED WARRANTIES AND OTHER TERMS THAT MAY BE IMPOSED BY LAW, IF ANY, ARE LIMITED IN DURATION TO THE PERIOD OF THE ABOVE EXPRESS WARRANTY. OMRON SHALL NOT BE LIABLE FOR LOSS OF USE OR ANY OTHER SPECIAL, INCIDENTAL, CONSEQUENTIAL, OR INDIRECT COSTS, EXPENSES, OR DAMAGES.

This warranty provides you with specific legal rights, and you may have other rights that vary by jurisdiction. Because of special local requirements, some of the above limitations and exclusions may not apply to you.

For Customer Service

• Visit our website at: www.omronhealthcare.com
• Call toll free: 1-800-634-4350

Specifications

This OMRON product is produced under the strict quality system of OMRON HEALTHCARE Co. Ltd., Japan.

Accessories/replacement parts

• electroTHERAPY Long-Life Pads (2 pads per box), Model #: PMLLPAD
• Electrode cords

NOTE: These specifications are subject to change without notice.

Important Information Regarding Electro Magnetic Compatibility (EMC)

With the increased number of electronic devices such as PCs and mobile (cellular) telephones, medical devices in use may be susceptible to electromagnetic interference from other devices. Electromagnetic interference may result in incorrect operation of the medical device and create a potentially unsafe situation. Medical devices should also not interfere with other devices.

In order to regulate the requirements for EMC (Electro Magnetic Compatibility) with the aim to prevent unsafe product situations, the IEC60601-1-2 standard has been implemented. This standard defines the levels of immunity to electromagnetic interferences as well as maximum levels of electromagnetic emissions for medical devices.

Medical devices manufactured by OMRON Healthcare conform to this IEC60601-1-2:2007 standard for both immunity and emissions.

Nevertheless, special precautions need to be observed:

• The use of accessories and cables other than those specified by OMRON, with the exception of cables sold by OMRON as replacement parts for internal components, may result in increased emission or decreased immunity of the device.
• Medical devices should not be used adjacent to or stacked with other equipment. In case adjacent or stacked use is necessary, the medical device should be observed to verify normal operation in the configuration in which it will be used.
• Refer to further guidance located at: http://www.omron-healthcare.com/export/sites/default/_global/EMC/EMCinfo-HV-F158-v01.pdf regarding the EMC environment in which the device should be used.