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

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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. 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 fields 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.
BATTERY
• Donotthrowthebatteriesintoare. 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 rechargeable batteries.
• Do not use batteries after their expiration date.
PADS
• Useonlypadsrecommendedbythemanufacturer to avoid affecting the safety and
effectiveness of electrical stimulation.
• Theelectricalperformancecharacteristicsofpadsmayaffectthesafetyand
effectiveness of electrical stimulation.
• Applyingpadsincorrectly could result in discomfort or skin burns.
• Detach the pads before replacing the batteries.
4. IMPORTANT SAFETY PRECAUTIONS AND WARNINGS

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•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.
• TENS is a symptomatic treatment and, as such, suppresses the sensation of pain that would
otherwise serve as a protective mechanism.
• Effectiveness is highly dependent upon patient selection by a practitioner qualied in the
management of pain patients.
• Youmayexperienceskinirritationorhypersensitivity due to the electrical stimulation or
electrical conductive medium (gel).
• Keepunitawayfromyoungchildren. The unit contains small pieces that may be swallowed.
Immediately contact your physician.
• Ensure that this device has acclimated to room temperature before using. Using this
device after an extreme temperature change could lead to an improper operation. OMRON
recommends waiting for approximately 2 hours for the device to warm up or cool down
when the device is used in an environment within the temperature specied as operating
conditions after it is stored either at the maximum or at the minimum storage temperature.
For additional information of operating and storage/transport temperature, refer to
“SPECIFICATIONS”.
PossibleAdverseReactions
• Donotusetotreatoneregionforextendedperiodsoftime(morethan30minutesa
session,upto3times/day) or muscles in that region may become exhausted and sore.
4. IMPORTANT SAFETY PRECAUTIONS AND WARNINGS

13
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. Anyofthemodescansafelybeused
onbodypartsorpainsdescribedinthismanualortheQuickStartGuide/PadPlacement
Guide. This device can be used in conjunction with any other pain treatment or medication.
TENS (Transcutaneous Electrical Nerve Stimulation) 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
Howdoesitwork?
Scientic 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 ever reaching the brain from the source of the pain.
2.The gentle electrical pulses increase the production of the body’s natural pain killer,
such as endorphins.
3.The electrical stimulation improves blood circulation. Muscles contract and relax with
the ow of the electrical stimulation. With repeated contracting and relaxing, the blood
ows in and out and the blood circulation is improved.

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6. KNOW YOUR UNIT
PACKAGE CONTENTS
Pocket Pain Pro Unit
Front Back 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
Pad Holder (1 standard)
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).
(Only use OMRON manufactured pads or cords with this unit).
4. Automatic 15-minuteshutoff.
5. Thelights indicate what mode and intensity level the device is set.
6. BatteryLight lights up to remind you to replace the batteries.
7. PadLight blinks if pad falls off.

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BUTTONS AND THEIR FUNCTIONS
Cord Jack
Mode Light
Each light corresponds to a mode.
Intensity Light
Power Button
1. Press ▲/▼ to choose mode.
2. After selecting the mode:
Press ▲ for higher intensity.
Press ▼ for lower intensity.
Pad Light
Battery Light
Set/Start Button
After choosing the mode:
Mode/Intensity Button
Press Set/Start to select the mode.
Select mode and intensity
according to your needs.
If the battery is low, battery light
will light up.
Press once for “ON” and again
for “OFF”.
If the pad detaches, pad light will
blink.
( [GETSTARTEDWITH
YOURTHERAPY] STEP 2 and
the Back of Main Unit)
( [GETSTARTEDWITH
YOURTHERAPY] STEP 2)
( [GETSTARTEDWITH
YOURTHERAPY] STEP 3)
( [GETSTARTEDWITH
YOURTHERAPY] STEP 3)
( [TROUBLESHOOTING])
( [GETSTARTEDWITH
YOURTHERAPY] STEP 2)
6. KNOW YOUR UNIT

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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
1Turn the unit over, and remove
the battery cover using a hard
object (such as the tip of a pen,
thin screwdriver).
2Insert batteries.
Make sure the
signs correspond when
inserting batteries.
3Reinstall the
battery cover.
STEP 2 – ATTACH ELECTRODE CORD TO THE MAIN UNIT
Attach the electrode cord plug to the bottom of the main unit.
7. ASSEMBLY STEPS

17
7. ASSEMBLY STEPS
STEP 3 – SNAP EITHER ELECTRODE CORD TO EACH OF THE PADS
Fortherst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rsttimeuse,removetheclearplasticlmfromthebackof
thepad.
Discard the plastic lm backing as well as the clear packaging.
STORING PADS ON PAD HOLDER
Remove plastic lm and put the sticky side of the pads on either side of the pad holder.
Pad Holder
pad sticky side up
pad facing down

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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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
pads.
• Donotsharepads.
Before starting your therapy, rate your pain from 1 low to 10 high.
This mental check gives you a basis you can compare to once the session is complete.
Attach both pads on the shoulder
according to your pain. Attach one pad on the front and on the back of
your shoulder.
SHOULDER
WARNING
• Do not use near the heart, on both sides of the chest cavity
or across your chest because the introduction of electrical
current may cause rhythm disturbances which could be
lethal.
Attach both pads on either side of
the region where you feel pain.
ARM

19
8. GET STARTED WITH YOUR THERAPY
Attach one pad below
and above the region in
pain, both on same side.
Attach both pads on the lower back according to your pain.
Place pads on muscle of back, not on spine, for optimal therapy.
LOWER BACK
(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.
Outside
Inside
(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.
WARNING
• Do not put the pads on the bottom
of both feet at the same time.
LEG & FOOT

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(KNEE)
Attach both pads above the knee or
above and below the joint with pain.
(ELBOW)
Attach both pads on either side of
the joint with the pain.
JOINT
STEP 2 – SELECT 1 OF 5 MODES
jPress the Power button.
k Press the ▲(Up) or ▼(Down) button to choose 1 of the 5 modes.
Modescannotbecombined.
lPress the Set/Start button to select the mode.
It will start the therapy at the intensity level of 1.
Mode
Press
Set/Start Button
(Mode/Intensity Button)
Press
Power Button
Select a pain mode:
1. Arm/Shoulder
2. Lower Back
3. Leg/Foot
Select a massage-like mode:
4. Knead
5. Steady
8. GET STARTED WITH YOUR THERAPY