Omron Pocket Pain Pro PM400 User manual

INSTRUCTION MANUAL
TENS Therapy Pain Relief
Pocket Pain Pro®
PM400
Pads are for Single Patient Use Only
®
All for Healthcare
ENGLISH

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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........................................................................... 13
6. KNOW YOUR UNIT.....................................................................................................14
7. ASSEMBLY STEPS.......................................................................................................16
8. GET STARTED WITH YOUR THERAPY .................................................................18
9. HOW TO CONTROL AND REDUCE YOUR PAIN.................................................. 23
10. CLEANING AND STORAGE ................................................................................... 25
11. TROUBLESHOOTING .............................................................................................. 27
12. LIMITED WARRANTY............................................................................................ 30
13. SPECIFICATIONS.......................................................................................................31
14. FCC STATEMENT ..................................................................................................... 33
15. GUIDANCE AND MANUFACTURER’S DECLARATION .................................. 34

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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 rst 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.
This box contains the following components:
• Pocket Pain Pro Unit
• Electrode Cords
• 2 LONG LIFE PADS™
• Pad Holder
• 2 AAA Batteries
• Instruction Manual
• Quick Start Guide / Pad Placement Guide

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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.
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 defibrillator 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.
• Together 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 or whenattachedtothebody,electronic
monitoringequipment (e.g. cardiac monitors, ECG alarms), which may not operate
properly when the electrical stimulation device is in use.
• For Hospitals and Clinics, Simultaneous connection of a patient toa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. 1m) 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.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.

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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.
•NEVER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,
difficulty in breathing, or
adverse effects on heart rhythm
or blood pressure.
Neartheheart, or on genital
area.
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 soles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 areas of skinthatlacknormalsensation.
4. IMPORTANT SAFETY PRECAUTIONS AND WARNINGS

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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.
• If you have any infectious disease or illness, consultwithyourphysician before using
this unit.
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pads,leads,electrodes,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)
because 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.
CORD
• Do not wash the electrode cords.
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.
4. IMPORTANT SAFETY PRECAUTIONS AND WARNINGS

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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.
• 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. It may weaken or stop therapy, or
the unit may stop working.
Gelpadsmayalsosticktogether and cause gel to be removed when separating.
•DonotusepadsafterExp.date.
•Donotapplypadswithwethands.
•Donotleavepadsattachedtotheskinaftertreatment.
• Donotbendorfold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 [GET
STARTEDWITHYOURTHERAPY]STEP1- 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.
• Placepadsoneithersideofthepain,notdirectlyonthepain.
•Donotsharepadswithanotherperson.This may cause a skin irritation or infection.
Pads are intended for use by one person.
4. IMPORTANT SAFETY PRECAUTIONS AND WARNINGS