® INSTRUCTION MANUAL TENS Therapy Pain Relief Pocket Pain Pro® PM400 ENGLISH Pads are for Single Patient Use Only All for Healthcare
TABLE OF CONTENTS 1. INTRODUCTION............................................................................................................ 4 2. INTENDED USE............................................................................................................. 5 3. SAVE THESE INSTRUCTIONS.................................................................................... 6 4. IMPORTANT SAFETY PRECAUTIONS AND WARNINGS..................................... 7 5. HOW POCKET PAIN PRO WORKS................
1. INTRODUCTION Thank you for purchasing the Omron Pocket Pain Pro Model PM400. In order to use the unit safely, read the complete manual carefully before using the unit for the first time. Keep this instruction manual in a convenient place or store with the unit for future reference. • Keep your purchase receipt as proof of purchase for warranty coverage.
2. INTENDED USE The OMRON Pocket Pain Pro 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 Mode 1 (Arm/Shoulder) or Mode 3 (Leg/Foot) 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. • Together with a life-supporting medical electronic device such as an artificial heart or lung or respirator. • For Hospitals and Clinics, in the presence of or when attached to the body, electronic monitoring equipment (e.g.
4. IMPORTANT SAFETY PRECAUTIONS AND WARNINGS DO NOT USE ON THESE INDIVIDUALS • Pregnant women. •D o 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. • Use caution if you have a tendency to bleed internally, such as following an injury or fracture.
4. IMPORTANT SAFETY PRECAUTIONS AND WARNINGS DO NOT USE THIS UNIT 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. PAIN MANAGEMENT WARNINGS • If you have had medical or physical treatment for your pain, consult with your physician before using this unit.
4. IMPORTANT SAFETY PRECAUTIONS AND WARNINGS 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. PRECAUTIONS REGARDING THE PADS • Do not move the pads to another location while the unit is on. • Therapy won’t work with just one pad. You MUST USE 2 PADS at the same time.
4. IMPORTANT SAFETY PRECAUTIONS AND WARNINGS CAUTION WHILE USING UNIT MAIN UNIT • If the unit is not functioning properly or you feel discomfort, immediately stop using the unit. • Do not use for any other purpose except for what it is intended. • Do not place in a room with high humidity, such as a bathroom. This will damage the unit. Ideal temperature for using 50 °F - 104 °F (10 °C - 40 °C), 30 % - 80 % relative humidity. • Do not use the unit without proper lighting.
4. IMPORTANT SAFETY PRECAUTIONS AND WARNINGS • Place pads at least 1 inch (3 cm) apart for optimal results. 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.
5. HOW POCKET PAIN PRO WORKS What is it? The OMRON Pocket Pain Pro is a portable device that relieves chronic, acute* and arthritic pain through the pain relief of TENS. 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.
6. KNOW YOUR UNIT PACKAGE CONTENTS Pocket Pain Pro Unit Front Back Pad Holder (1 standard) Electrode Cords 2 LONG LIFE PADS™ (1 standard pair) Batteries (2 AAA size (LR03) batteries) Instruction Manual (This Manual) Quick Start Guide /Pad Placement Guide FEATURES 1. Five pre-set modes (Arm/Shoulder, Lower Back, Leg/Foot, Knead, Steady). 2. Ten intensity levels (1 low to 10 high). 3. Pair of pads (durable, re-usable, washable, up to 150 uses).
6. KNOW YOUR UNIT BUTTONS AND THEIR FUNCTIONS Mode Light Each light corresponds to a mode. Intensity Light ( [GET STARTED WITH YOUR THERAPY] STEP 3) Power Button Press once for “ON” and again for “OFF”. ( [GET STARTED WITH YOUR THERAPY] STEP 2 and the Back of Main Unit) Mode/Intensity Button Select mode and intensity according to your needs. 1. Press ▲/▼ to choose mode. ( [GET STARTED WITH YOUR THERAPY] STEP 2) 2. After selecting the mode: Press ▲ for higher intensity. Press ▼ for lower intensity.
7. ASSEMBLY STEPS Before using your unit, inspect to ensure that: 1. Cord is not broken. 2. Pad gel is not damaged. 3. Electrode cord connection is not broken. 4. Unit is intact and working. 5. There is no battery leakage. STEP 1 – INSERT BATTERIES Battery Cover 1 Turn the unit over, and remove 2 Insert batteries. the battery cover using a hard Make sure the object (such as the tip of a pen, signs correspond when thin screwdriver). inserting batteries. 3 Reinstall the battery cover.
7. ASSEMBLY STEPS STEP 3 – SNAP EITHER ELECTRODE CORD TO EACH OF THE PADS For the first time use, take the pads out of the sealed package. CAUTION • Do NOT turn unit on until pads are on your skin. • You MUST USE BOTH PADS or stimulation will not work. NOTE: Pads will not stick if the skin has too much hair. We recommend shaving the area for effective treatment. STEP 4 – REMOVE AND DISCARD PLASTIC FILM FROM PADS For the first time use, remove the clear plastic film from the back of the pad.
8. GET STARTED WITH YOUR THERAPY (USE FOR A MAXIMUM OF 30 MINUTES PER SESSION) STEP 1 – PAD PLACEMENT ARM CAUTION For optimal therapy: • Place pads on either side of the pain, not directly on the pain. • Place pads at least 1 inch (3 cm) apart. • MUST USE 2 PADS at a time for therapy to work. • Do not overlap pads or put on top of each other. • Do not add spray, lotions or creams to skin or Attach both pads on either side of pads. the region where you feel pain. • Do not share pads.
8. GET STARTED WITH YOUR THERAPY LOWER BACK Attach both pads on the lower back according to your pain. Place pads on muscle of back, not on spine, for optimal therapy. LEG & FOOT Attach one pad below and above the region in pain, both on same side. Outside Inside (HIP & THIGH) Attach both pads on either side of the area with pain. (CALF) Attach both pads on the calf where you feel pain. WARNING • Pads should not be placed simultaneously on the calves of both legs.
8. GET STARTED WITH YOUR THERAPY JOINT (ELBOW) (KNEE) Attach both pads on either side of the joint with the pain. Attach both pads above the knee or above and below the joint with pain. STEP 2 – SELECT 1 OF 5 MODES Press Power Button Mode (Mode/Intensity Button) Press Set/Start Button j Press the Power button. k Press the ▲(Up) or ▼(Down) button to choose 1 of the 5 modes. Modes cannot be combined. l Press the Set/Start button to select the mode.
8. GET STARTED WITH YOUR THERAPY How to change modes during therapy? If you want to change modes during therapy, press the Set/Start button and the ▲(Up) or ▼(Down) button to select a new mode. You can only use ONE MODE at a time. If you don’t press the Set/Start button to select the mode, the unit will automatically turn off after 3 minutes. How to select the right mode? Any of the modes can be used on body parts or pains described in this manual or Quick Start Guide/Pad Placement Guide.
8. GET STARTED WITH YOUR THERAPY STEP 3 – SELECT INTENSITY LEVEL (1 LOW – 10 HIGH) The unit automatically starts at the intensity level of 1. Slowly increase the intensity level by pressing the ▲(Up) button. You should feel a gentle pulsing sensation. How do I select the right intensity level for my pain? Each time you press the ▲(Up) or ▼(Down) button, it moves to another intensity level. If the stimulation sensation becomes weaker or disappears, increase the intensity.
9. HOW TO CONTROL AND REDUCE YOUR PAIN When should you start therapy? 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 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.
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 of 1 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 • Place the unit, pads with electrode cords on pad holder, Pad Placement Guide and Instruction Manual inside the original box.
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... The intensity is not felt. Very weak intensity level. The skin turns red or the skin feels irritated. No power source. Possible causes... Are you using only 1 pad? Try this solution... Put the other pad on your skin. You must use BOTH PADS for therapy to work.
11. TROUBLESHOOTING If this happens... Power cut off during use. Possible causes... Are the batteries weak? Battery Light lights up. Is the cord broken? Are the batteries weak? Pad gel does not stick to skin. Have you removed the transparent film from the pad? Is the pad wet? or Is your skin too wet? The pad gel may be damaged. Is there too much hair on your skin? Is the adhesive surface of pads dirty or dry? Try this solution... Replace both batteries at the same time. Replace cord.
11. TROUBLESHOOTING If this happens... Pad Light is blinking. Possible causes... Are both pads attached to the body? Have you removed the transparent film from the pad? Is the cord properly connected to the main unit? Try this solution... Re-attach dislocated pad(s) onto the skin firmly. Peel off film on the adhesive surface of pads. Connect cord plug correctly into the jack at the bottom of the main unit.
12. LIMITED WARRANTY Your OMRON Pocket Pain Pro 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. The pads supplied with the unit are warranted for 30 days from the date of purchase. The above warranties extend only to the original retail purchaser. We will, at our option, replace without charge, any unit covered by the above warranty.
13.
13. SPECIFICATIONS Accessories/replacement parts (To order : OmronHealthcare.com) • PMLLPAD-L (3”x4.5” (75 mm × 114 mm)) • PMLLPAD (2.
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 Pocket Pain Pro Information for Accompanying Documents in the Scope of IEC60601-1-2:2014 Important information regarding Electromagnetic Compatibility (EMC) PM400 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 PM400 on the website.
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. For questions: 1-800-634-4350 Get general pain info: OmronHealthcare.com © 2019 OMRON HEALTHCARE, INC.
