Omron Max Power Relief PM500 User manual

INSTRUCTION MANUAL
TENS Therapy Pain Relief
Max Power Relief®
PM500
Pads are for Single Patient Use Only
®
ENGLISH

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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...................................................................... 13
6. KNOW YOUR UNIT.....................................................................................................14
7. ASSEMBLY STEPS.......................................................................................................16
8. GET STARTED WITH YOUR THERAPY ................................................................ 19
9. HOW TO CONTROL AND REDUCE YOUR PAIN.................................................. 26
10. CLEANING AND STORAGE ................................................................................... 28
11. TROUBLESHOOTING .............................................................................................. 30
12. LIMITED WARRANTY............................................................................................ 32
13. SPECIFICATIONS...................................................................................................... 34
14. FCC STATEMENT..................................................................................................... 36
15. GUIDANCE AND MANUFACTURER’S DECLARATION .................................. 37

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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. The Max Power Relief uses comfortable, self-adhesive Long Life Pads™ that can
be used up to 150 times.
TENS is a safe and drug-free pain relief solution that has been used for over 40 years by
medical professionals such as physical therapists and chiropractors.
* Acute pain refers to sore or achy muscles due to strain from exercise or normal household and work activities.
• Register your product online at www.register-omron.com.
• Keep your purchase receipt as proof of purchase for warranty coverage.

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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.
Environments of Use: Clinics, hospital and home environments
Patient Population: Adult

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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 debrillator or other
implanted metallic or electronic device. Such use could cause electric shock, burns,
electrical interference or death.

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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 articial heart or lung or
respirator.
• For Hospitals and Clinics: In the presence of electronic monitoring equipment such as
cardiac monitors and ECG alarms because the equipment may not operate properly when
the electrical stimulation device is in use.
• For Hospitals and Clinics: Simultaneous connection of a patient to high frequency
surgical ME equipment may result in burns at the site of the stimulator electrodes and
possible damage to the stimulator.
• For Hospitals and Clinics: Operation in close proximity (e.g. 1 m) to a shortwave or
microwave therapy ME equipment may produce instability to the stimulator output.
DO NOT USE THIS UNIT UNDER THESE CONDITIONS
• Consult with your physician before using this unit.
The unit may cause lethal rhythm disturbances in certain susceptible individuals. If you
have had a recent surgical procedure, the stimulation may disrupt the healing process.
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.

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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.
• Use caution if you have a tendency to bleed internally, such as following an injury or
fracture.
• If you have suspected or diagnosed heart disease, you should follow precautions
recommended by your physician.
• If you have suspected or diagnosed epilepsy, you should follow precautions
recommended by your physician.
• Use caution if stimulation is applied over the menstruating uterus.
• DO NOT APPLY THE PADS TO THESE BODY AREAS:
The head, the mouth, or any area of the face.
The neck or any area of the throat because this could cause severe muscle spasms
resulting in closure of the airway, difculty in breathing, or adverse effects on
heart rhythm or blood pressure.
Near the heart, or on genital area.
4. IMPORTANT SAFETY PRECAUTIONS AND WARNINGS

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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.
Open wounds or rashes or over swollen, red, infected or inamed areas or skin
eruptions (such as varicose veins, phlebitis, thrombophlebitis and thrombosis), or on top
of or close to cancerous lesions, or over ares of skin that lack normal sensation.
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.
• If your pain does not improve, becomes seriously chronic or severe, or continues for
more than ve days, stop using the unit and consult with your physician.
• The mere existence of pain functions as a very important warning telling us that
something is wrong. Therefore, if you suffer from any serious illness, consult your
physician in order to conrm that it is advisable for you to use this unit.
4. IMPORTANT SAFETY PRECAUTIONS AND WARNINGS

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DO NOT ALTER THE UNIT
• Do not plug this cord into anything other than this unit.
• No modication 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).
• If you experience any skin irritation or redness after a session, do not
continue stimulation in that area of the skin.
Possible Adverse Reactions
• You should stop using the unit and consult with your physician if you experience
adverse reactions from the unit.
• 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.
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 TWO PADS at the same time.
• Make sure the components are connected well and the pads are xed on the part of
the body you wish to treat or the therapy may not be effective.
• Pad should not touch any metal object, such as a belt buckle, necklace, or other metal
worn under clothing.
• Do not overlap pads or put pads on top of each other.
Gel pads may also stick together and cause gel to be removed when separating.
• Do not share pads with another person. This may cause a skin irritation or infection.
Pads are intended for use by one person.
• Do not leave pads attached to the skin after treatment.
4. IMPORTANT SAFETY PRECAUTIONS AND WARNINGS

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• 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.
• Always 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. The self-adhesive pads will adhere to your skin.
• Do not add spray, lotions or creams to skin or pads.
• 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.
CAUTION WHILE USING UNIT
MAIN UNIT
• If the unit is not functioning properly or you feel discomfort, immediately stop using
it.
• 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. You may not be able to operate unit
successfully.
• While using this device, make sure that no mobile phone or any other electrical devices that emit
electromagnetic elds is within 12 inches (30 cm). This may result in poor performance of the
device.
• Do NOT turn unit on until pads are on your skin.
CORD
• Do not insert the electrode plug into any place other than the jack on the unit.
• Do not pull on the electrode cord during treatment.
• Do not bend or pull the end of the cord.
• When pulling out the cord from the unit, hold the plug and pull.
• Replace the cord when broken or damaged.
4. IMPORTANT SAFETY PRECAUTIONS AND WARNINGS