® INSTRUCTION MANUAL TENS Therapy Pain Relief Max Power Relief® PM500 ENGLISH Pads are for Single Patient Use Only
TABLE OF CONTENTS 1. INTRODUCTION............................................................................................................ 3 2. INTENDED USE............................................................................................................. 4 3. SAVE THESE INSTRUCTIONS.................................................................................... 5 4. IMPORTANT SAFETY PRECAUTIONS AND WARNINGS..................................... 6 5. HOW MAX POWER RELIEF WORKS...............
1. INTRODUCTION Thank you for purchasing the OMRON Max Power Relief. The Max Power Relief is a portable TENS (Transcutaneous Electrical Nerve Stimulation) device that provides relief of chronic, acute* and arthritic pain. It is designed to reduce and relieve muscle and joint pain, stiffness and numbness in the back, arms, legs, shoulder and foot by applying electrical nerve stimulation to the surface of the skin near the site of the pain.
2. INTENDED USE This device is 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 and work activities. When used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis, use the Shoulder mode of stimulation.
3. SAVE THESE INSTRUCTIONS Symbols Glossary: For symbol information, visit: OmronHealthcare.com/symbols-glossary 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.
4. IMPORTANT SAFETY PRECAUTIONS AND WARNINGS WARNING Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury. DO NOT USE THIS UNIT WITH THESE OTHER DEVICES: • Do not use this device while using another TENS device. • With a life-supporting medical electronic device such as an artificial heart or lung or respirator.
4. IMPORTANT SAFETY PRECAUTIONS AND WARNINGS DO NOT USE ON THESE INDIVIDUALS • Pregnant women. • Do not use on children or infants because this device has not been evaluated for pediatric use. • Keep out of the reach of young children because the electrode cord could cause strangulation. • Persons incapable of expressing their thoughts or intentions. • Persons incapable of operating the unit by themselves.
4. IMPORTANT SAFETY PRECAUTIONS AND WARNINGS Both sides of the chest cavity simultaneously (lateral or front and back), or across your chest because the introduction of electrical current may cause rhythm disturbances which could be lethal. On the calves of both legs at the same time because this may cause cardiac disturbance. On the bottom of both feet at the same time because this may cause cardiac disturbance.
4. IMPORTANT SAFETY PRECAUTIONS AND WARNINGS DO NOT ALTER THE UNIT • Do not plug this cord into anything other than this unit. • No modification of this unit is allowed. • Use this unit only with the leads, electrodes, pads and accessories recommended by the manufacturer to avoid damage to the unit. WARNINGS REGARDING THE PADS • Apply pads to normal, healthy, dry, clean skin (of adult patients).
4. IMPORTANT SAFETY PRECAUTIONS AND WARNINGS • Do not bend or fold the pads because the gel may get damaged and it won’t stick or function properly. • To avoid damage to the adhesive surface of the pads, put the pads only on the skin or on the plastic pad holder provided. • A lways place clean pads in accordance with illustrations provided (Refer to pages 19-22, Pad Placement). • Do not apply ointment or any solvent to the pads or to your skin because it will disrupt the pads from functioning properly.
4. IMPORTANT SAFETY PRECAUTIONS AND WARNINGS BATTERY • Do not throw the batteries into a fire. The batteries may explode. • Dispose of the unit, batteries, and components according to applicable legal regulations. Unlawful disposal may cause environmental pollution. • Do not mix alkaline and manganese batteries as this will shorten the battery life. • During therapy, do not remove the battery cover and do not touch the battery terminals. • Do not use batteries after their expiration date.
4. IMPORTANT SAFETY PRECAUTIONS AND WARNINGS Possible Adverse Reactions • Do not use to treat one region for extended periods of time (more than 30 minutes a session, up to three times/day) or muscles in that region may become exhausted and sore.
5. HOW MAX POWER RELIEF WORKS How does it work? The OMRON Max Power Relief is a powerful TENS device that provides relief of chronic, acute* and arthritic pain. Scientific theory suggests that TENS therapy may work in several ways: 1. Gentle electrical pulses move through the skin to nearby nerves to block or shut out the pain message from ever reaching the brain from the source of the pain. 2. Gentle electrical pulses increase the production of the body’s natural pain killers, such as endorphins. 3.
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6. KNOW YOUR UNIT FEATURES 1. Nine preset modes (Arm, Lower Back, Leg, Foot, Shoulder, Joint, Tap, Knead, Rub). 2. Fifteen intensity levels (1 low to 15 high). 3. Pair of pads (durable, reusable, washable, up to 150 uses). (Only use OMRON manufactured pads and cords with this unit). 4. Automatic 15-minute shut off. 5. Big screen lets you clearly control your therapy with mode, intensity level and minutes left displayed. 6. Low battery icon displays to remind you when to replace the batteries. 7.
7. ASSEMBLY STEPS Before using your unit, ensure that: 1. The cord is not broken. 2. The gel pad is not damaged. 3. The electrode cord connection is not broken. 4. The unit is intact and working. 5. There is no battery leakage. STEP 1 – INSERT BATTERIES 1 Remove the battery cover on the back using a coin. Battery Cover 2 Insert batteries. Make sure the signs correspond when inserting batteries. 3 Reinstall the battery cover. Tighten with a coin.
7. ASSEMBLY STEPS STEP 2 – ATTACH ELECTRODE CORD TO THE MAIN UNIT Attach the electrode cord plug to the bottom of the main unit. STEP 3 – SNAP EITHER ELECTRODE CORD TO EACH OF THE PADS For the first time, take the pads out of the sealed package. CAUTION • Do NOT turn unit on until pads are on your skin. • Therapy won’t work with just one pad. You MUST USE TWO PADS at the same time. NOTE: Pads will not stick if the skin has too much hair. We recommend shaving the area for effective treatment.
7. ASSEMBLY STEPS STEP 4 – REMOVE AND DISCARD PLASTIC FILM FROM PADS Remove the clear plastic film from the back of the pad. Discard the plastic film backing as well as the clear packaging. STORING PADS ON PAD HOLDER Remove plastic film and put sticky side of pads on either side of the pad holder. STEP 5 – ATTACH THE UNIT TO THE BELT CLIP CAUTION • T he clip may fall off if attached to soft or thin clothing.
8. GET STARTED WITH YOUR THERAPY (USE FOR A MAXIMUM OF 30 MINUTES PER SESSION) STEP 1 – PAD PLACEMENT CAUTION For optimal therapy: • Place pads on each side of the pain, not directly on the pain. • Place pads at least 1 inch (3 cm) apart for optimal results. • T herapy won’t work with just one pad. You MUST USE TWO PADS at the same time. • Do not overlap pads or put pads on top of each other. • Do not add spray, lotions or creams to skin or pads. • Do not share pads with another person.
8. GET STARTED WITH YOUR THERAPY STEP 1 – PAD PLACEMENT (continued) ARM LOWER BACK Attach one pad below and above the region in pain, both on same side. Attach pads on each side of the region where you feel pain. JOINT LEG (ELBOW) Attach pads on each side of the joint with the pain. (HIP & THIGH) Attach pads on each side of the area with pain.
8. GET STARTED WITH YOUR THERAPY STEP 1 – PAD PLACEMENT (continued) JOINT (KNEE) Attach both pads above the knee or above and below the joint with pain. LEG (CALF) Attach both pads on the calf where you feel pain. WARNING • Do not apply the pads on the calves of both legs at the same time. Outside Inside FOOT (ANKLE) Attach pads on the left for pain on the outside of your ankle/foot. Attach the pads on the right for pain on the inside of your ankle/foot.
8. GET STARTED WITH YOUR THERAPY STEP 1 – PAD PLACEMENT (continued) SHOULDER Attach both pads on the shoulders according to your pain. SHOULDER Attach one pad on the front and on the back of your shoulder. WARNING • Do not apply the pads on both sides of the chest cavity simultaneously (lateral or front and back), or across your chest because the introduction of electrical current may cause rhythm disturbances which could be lethal. • Do not apply the pads near the heart.
8. GET STARTED WITH YOUR THERAPY STEP 2 – SELECT 1 OF 9 MODES • Push “ON/OFF”. • Choose 1 of the 9 modes. Modes cannot be combined. Choose a massage-like mode 1. Tap 2. Knead 3. Rub Or choose a pain mode: 4. Arm 5. Lower Back 6. Leg 7. Foot 8. Joint (Knee/elbow/wrist) 9. Shoulder Push “MODE” Push “ON” How to switch modes The unit automatically defaults to the last mode selected. Each time you push the mode button, it switches to the next mode at the lowest intensity. You can only use ONE MODE at a time.
8. GET STARTED WITH YOUR THERAPY STEP 2 – SELECT 1 OF 9 MODES (continued) Arm Lower Back Leg Foot Therapies designed for Arm Lower Back Leg Foot What does the therapy deliver? Series of low to medium rate tapping, tingling and pulsing sensations. Series of high rate to low tingling sensations, followed by tapping. With higher intensity, you may feel kneading or massage-like sensations. Series of low to medium tapping and rubbing sensations. Series of low rate tapping, pulsing sensations.
8. GET STARTED WITH YOUR THERAPY STEP 3 – SELECT THE CORRECT INTENSITY LEVEL (1 LOW – 15 HIGH) Start at the lowest intensity level and slowly increase it by pushing the “▲(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 “▲(Up)” or “▼(Down)” arrow, it moves to another level. If the stimulation sensation becomes weaker or disappears, increase the intensity until it is restored.
9. HOW TO CONTROL AND REDUCE YOUR PAIN When should I start therapy? Use as soon as your pain begins. Start with one session (unit automatically turns off at 15 minutes). Get to your pain early If you get to your pain early, it may prevent the pain from becoming worse, or even chronic. It’s better for you to get it under control sooner so that it does not reach a high pain threshold where it limits your daily activities. How long should you use it? Start with one 15-minute session.
9. HOW TO CONTROL AND REDUCE YOUR PAIN 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 unit cannot address. Remember, this unit does not cure your pain or the original cause of the pain.
10. CLEANING AND STORAGE The unit is designed for repeated use over time. The pads will last up to 150 uses, or 5 months (based on use one time per day). Here are important cleaning and storage instructions: Cleaning the pads 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 adhere.
10. CLEANING AND STORAGE Storing the pads 1. Turn the unit off and remove the cord from the bottom of the unit. 2. Remove the pads from your body. 3. Leave the electrode cords connected to the pads. Place the pads on the pad holder, one pad on each side with the sticky side of each pad on the pad holder. 4. Wrap the electrode cords around the pad holder. Storing the unit and pads • Store the unit with the belt clip on. Store the pads with the electrode cords on the pad holder, and put into the pouch.
11. TROUBLESHOOTING If any of the below problems occur, check to make sure that no other electrical device is within 12 inches (30 cm). If the problem persists, refer to the table below. If this happens... Possible causes... Try this solution... The intensity is not felt. Very weak intensity level. Are you using only one pad? Put the other pad on your skin. You must use BOTH PADS for therapy to work. Have you removed the transparent film from the pad? Peel off film on the adhesive surface of pads.
11. TROUBLESHOOTING If this happens... Possible causes... Try this solution... Battery icon is empty. Are the batteries weak? Replace both batteries at the same time. Gel pad does not stick to skin. Have you removed the transparent film from the pad? Peel off film from the adhesive surface of pads. Is the pad wet? Is your skin too wet? Dry the pad. Dry the skin. The gel pad may be damaged. Replace the pad. Is there too much hair on your skin? Shave the immediate area for proper pad adhesion.
12. LIMITED WARRANTY Your OMRON Max Power Relief unit, excluding the batteries and pads, is warranted to be free from defects in materials and workmanship appearing within 1 year from the date of purchase, when used in accordance with the instructions provided with the device. The above warranty extends only to the original retail purchaser.
12. LIMITED WARRANTY This warranty provides you with specific legal rights, and you may have other rights that vary by jurisdiction. FOR CUSTOMER SERVICE Visit our web site at: OmronHealthcare.
13. SPECIFICATIONS Product Name Model # Power Source Battery Life Frequency PULSE Duration Maximum Output Voltage Power Control Operating and Storage Conditions (When using product) Transportation Conditions Weight Outer Dimension Classification of ME equipment IP classification Operation Mode Applied Part Durable period (Service Life) OMRON Max Power Relief PM500 REF HV-F023-Z DC 3 V (2 AAA alkaline batteries or 2 AAA manganese batteries) New batteries (2 AAA alkaline batteries) will last for approx.
13. SPECIFICATIONS Optional Accessories • PMLLPAD-L (3”x4.5” (75 mm × 114 mm)) • PMLLPAD (2.5”x4” (63 mm × 102 mm)) To order : OmronHealthcare.
14. FCC STATEMENT FCC CAUTION Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment. Note: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation.
15. GUIDANCE AND MANUFACTURER’S DECLARATION OMRON Max Power Relief Information for Accompanying Documents in the Scope of IEC60601-1-2:2014 Important information regarding Electromagnetic Compatibility (EMC) PM500 conforms to IEC60601-1-2:2014 Electromagnetic Compatibility (EMC) standard. Further documentation in accordance with this EMC standard is available at OmronHealthcare.com/emc. Refer to the EMC information for PM500 on the website.
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Omron Healthcare helps you make positive lifestyle changes with innovative medical solutions that you can use safely and accurately at home. OmronHealthcare.com For questions: 1-800-634-4350 Get general pain info: OmronPainRelief.
