Omron electro Therapy Pocket Pain Pro User manual

HV-F013-Z
9301669-0F
INTRODUCTION
Thank you for purchasing the Omron®Pocket Pain Pro™ Model PM3029.
In order to use the unit safely, read the complete manual carefully before using the unit for the fi 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
• Two AAA Batteries
• Instruction Manual
• Quick Start Guide / Pad Placement Guide
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.
Environments of Use: Clinics, hospital and home environments
Patient Population: Adult
SAVE THESE INSTRUCTIONS
SYMBOL GLOSSARY
Symbol Standard Number / Standard Title Reference No. / Title of symbol / Meaning of symbol
ISO 15223-1
Medical Devices- Symbols to be used with
medical device labels, labelling and information
to be supplied-Part 1 general guidelines
Symbol 5.4.3
Consult Instructions for Use
Indicates that the manual must be consulted for proper use of a medical device.
IEC 60601-1
Medical electrical equipment –Part 1: General
requirements for basic safety and essential
performance
Table D.1 20
Type BF applied part
F-TYPE APPLIED PART complying with the specifi ed requirements of this
standard to provide a higher degree of protection against electric shock than that
provided by TYPE B APPLIED PARTS
ISO 7010
Graphical symbols -- Safety colours and safety
signs -- Registered safety signs
P007
No access for people with active implanted cardiac devices
To prohibit people with active implanted cardiac devices from entering a
designated area
IEC 60417
Graphical symbols for use on equipment
5140
Non-ionizing electromagnetic radiation
To indicate generally elevated, potentially hazardous, levels of nonionizing
radiation, or to indicate equipment or systems e.g. in the medical electrical area
that include RF transmitters or that intentionally apply RF electromagnetic
energy for diagnosis or treatment.
ISO 15223-1
Medical Devices- Symbols to be used with
medical device labels, labelling and information
to be supplied-Part 1 general guidelines
Symbol 5.1.6
Catalogue number
Indicates the manufacturer’s catalogue number so that the medical device can
be identifi ed.
ISO 15223-1
Medical Devices- Symbols to be used with
medical device labels, labelling and information
to be supplied-Part 1 general guidelines
Symbol 5.4.4
Caution, consult accompanying documents
Indicates that all documents be consulted for proper use of the device.
ISO 15223-1
Medical Devices- Symbols to be used with
medical device labels, labelling and information
to be supplied-Part 1 general guidelines
Symbol 5.1.4
Use-by date
Indicates the date after which the medical device is not to be used.
IEC 60601-1
Medical electrical equipment –Part 1: General
requirements for basic safety and essential
performance
Table D.3
Symbol 2
Ingress protection rating
Protection against ingress of an object of ¬12.5 mm or more. Protection against
the ingress of vertically falling water drips with the device tilted at 15 degrees.
IMPORTANT SAFETY PRECAUTIONS AND WARNINGS
It is important that you read all the warnings and precautions included in this instruction manual because they are intended to keep
you safe, prevent injury and avoid a situation that could result in damage to the unit.
SAFETY SYMBOLS USED IN THIS INSTRUCTION MANUAL
DANGER Improper use may cause danger resulting in death or serious injury. These are situations in which the device
should not be used.
WARNING Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.
CAUTION Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate a injury to the
user or patient or damage to the equipment or other property.
DANGER
Do not use this unit with these other devices:
(1) If you have a pacemaker, implanted defi brillator, or other implanted metallic or electronic device.
Such use could cause electric shock, burns, electrical interference or death.
(2) Do not use this device while using another TENS device.
(3) Together with a life-supporting medical electronic device such as an artifi cial heart or lung or respirator.
(4) 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.
(5) 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.
(6) 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, inspect these things.
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.
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, diffi culty in breathing, or adverse effects on
heart rhythm or blood pressure.
Near the heart, or on genital area.
Both sides of the thorax 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 infl 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.
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 fi 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 confi rm that it is advisable for you to use this Pocket Pain Pro™ 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 any other device that is not an Omron PM3029.
No modifi 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.
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 fi 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 share pads with another person. This may cause a skin irritation or infection. Pads are intended for use by one person.
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 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 at least 1 inch apart for optimal results.
Single patient use only.
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 for.
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.
CORD
Do not wash the electrode cords.
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 fi 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.
PADS
Use only pads recommended by the manufacturer to avoid affect 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.
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 qualifi 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.
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.
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.
HOW Pocket Pain Pro™ WORKS
What is it?
The OMRON® Pocket Pain Pro™ unit is a portable device designed for adults only. 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 Quick Start Guide/Pad
Placement Guide. Just fi nd one that feels good and is comfortable on your pain. It can be successfully used in conjunction with any other
pain treatment or medication.
This type of therapy, called Transcutaneous Electrical Nerve Stimulator (TENS), has been used for over 30 years by medical professionals
such as physical therapists and chiropractors.
How does it work?
Scientifi 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. Furthermore, it is thought that the electrical stimulation improves blood circulation as well. Muscles contract and relax with the fl ow of
the electrical stimulation. With repeated contracting and relaxing, the blood fl ows in and out and the blood circulation is improved.
KNOW YOUR UNIT
PACKAGE CONTENTS
Pocket Pain Pro™ Unit
Front Back Electrode Cords 2 LONG LIFE PADS™
(1 standard pair)
Batteries
(two AAA size (LR03) batteries)
Instruction Manual (This Manual) Quick Start Guide /Pad Placement Guide
Pad Holder (1 standard)
HV
-F013-Z
9301669-0F
HV-F013-Z
9301670-4C
PM3029
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 let you clearly control your therapy with mode, intensity level.
6. Battery Light lights up to remind you to replace the batteries.
7. Pad Light blinks if pad falls off.
BUTTONS AND THEIR FUNCTIONS
( [TROUBLESHOOTING])
Cord Jack
Mode Light
Each light corresponds to a mode.
Intensity Light
Power Button
Select mode and intensity according to your needs.
1. Press ▲/▼ to choose mode.
2. After selecting the mode:
Press ▲ for higher intensity.
Press ▼ for lower intensity.
Pad Light
If the pad dislodges, Pad Light will blink.
Battery Light
If the battery is low, Battery Light will light up.
Set/Start Button
After choosing the mode:
( [GET STARTED WITH YOUR
THERAPY]STEP 2 and the Back of Main
Unit)
( [GET STARTED WITH YOUR
THERAPY]STEP 3)
Mode/Intensity Button
( [GET STARTED WITH YOUR THERAPY]STEP 3)
Press once for “ON” and again for “OFF”.
( [GET STARTED WITH YOUR
THERAPY]STEP 2)
Press Set/Start to select the mode.
( [GET STARTED WITH YOUR THERAPY]STEP 2)
ASSEMBLY STEPS
Before using your unit, inspect these things.
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.
STEP 3 – SNAP EITHER ELECTRODE CORD TO EACH OF THE PADS
For the fi rst time, take the pads out of the sealed package.
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 fi rst time, remove the clear plastic fi lm from the back of the pad.
Discard the plastic fi lm backing as well as the clear packaging.
STORING PADS ON PAD HOLDER
Remove plastic fi lm and put sticky side of pads on either side of the pad holder. Pad Holder
pad sticky side up
pad facing down
GET STARTED WITH YOUR THERAPY
(USE FOR A MAXIMUM OF 30 MINUTES PER SESSION)
STEP 1 – PAD PLACEMENT
For optimal therapy:
Place pads on either side of the pain, not directly on the pain.
Place pads at least 1 inch apart.
MUST USE TWO 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
Do not use near the heart, on both sides of the thorax 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
Continue to the back

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.
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.
Do not put the pads on the bottom of both
feet at the same time.
LEG & FOOT
(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
Press the Power button.
 Press ▲(Up) or ▼(Down) button to choose 1 of the 5 modes.
Modes cannot be combined.
Press the Set/Start button to select the mode.
It will start the therapy at the intensity level of 1.
Select a pain mode:
1. Arm/Shoulder
2. Lower Back
3. Leg/Foot
Select a massage-like mode:
4. Knead
5. Steady
How to change modes during therapy?
If you want to change modes during therapy, press the Set/Start button and ▲(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.
Select the mode that feels right for your unique pain.
Therapies
designed for Arm/Shoulder Lower Back Leg/Foot Knead Steady
Mode Light
and the Back of
Main Unit
Potential
conditions
Stiffness, sore or achy,
tight feeling.
Stiffness, soreness,
muscle spasm, nerve
pain.
Swelling, fatigue,
chilly feeling, sore or
achy.
Stiffness, soreness,
tight feeling.
Stiffness, soreness,
tight feeling, or achy.
What does
the therapy
deliver?
Series of low to
high rate tapping,
pulsing, kneading
and massage-like
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 rate
tapping, pulsing
sensations.
Series of medium rate
pulsing sensations to
mimic massage.
Series of regular
pulsing sensations that
do not change.
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 ▲(Up) button. You should feel a
gentle pulsing sensation.
How do I select the right intensity level for my pain?
Each time you press ▲(Up) or ▼(Down) button, it moves to another level. If the stimulation sensation becomes weaker or disappears,
increase the intensity. But, if the sensation is at all uncomfortable, press ▼(Down) button to decrease the intensity.
• Press ▲ for higher intensity.
• Press ▼ for lower intensity.
If Pad Light is blinking, the unit will automatically turn off after 30 seconds. ( “TROUBLE SHOOTING”)
What intensity level is my unit on?
Press ▲(Up)/▼(Down) button to increase/decrease the intensity. The Intensity Light moves up/down after pressing it once or twice (as shown
below). Therefore, the light may not move up/down, but the intensity level does increase/decrease each time you press it.
ntensity Light:
ntensity level 1 or 2 3 or 4 5 or 6 7 or 8 9 or 10：
How long is the therapy?
The unit will continue automatically for 15 minutes before it shuts off. If you want to stop the therapy while in use, press the Power button.
We recommend a total of 30 minutes therapy in one sitting, up to 3 times/day.
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.
How long should you use it?
Start with one 15 minute session. Always turn unit off with pads still on. Rate your pain to check your progress, 1 low to 10 high. Stop therapy
session if pain has reduced or stopped. Press the Power button to continue therapy for another 15 minute session.
1 session: 15 minute automatic shut-off Max minutes/session: 30 minutes Max times/day: 3 times
See warnings. Long-time treatment and strong stimulation may cause muscular fatigue and may generate adverse effects.
When to stop using the unit?
1. If you experienced an adverse reaction (skin irritation/redness/burns, headache or other painful sensation, or if you feel any unusual
discomfort).
2. If your pain does not improve, becomes seriously chronic and severe, or continues for more than fi ve days.
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. It provides temporary relief or reduction of pain so that you can
control your life and activities better.
Before using, check these points to make sure everything is working properly.
1. Make sure the cord is not broken.
2. Check that the pad adhesive sticks and is not damaged.
3. The electrode cord connection is not broken.
4. The unit is intact and in working order.
5. There is no battery leakage.
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 1/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 diffi cult to attach.
• Wash the pad softly with your fi ngertips under slow running cold water for several seconds (do not use a sponge/
cloth/sharp object like a nail on adhesive side, do not use detergents, chemicals or soap).
3. Pads can be washed after 15 uses, approximately ten times for up to 150 uses. Do not wash the pads too long or too frequently.
4. Dry the pads and let the adhesive surface air-dry completely. Do not wipe with a tissue paper or cloth.
5. Pads are replaceable and can be purchased when needed by calling 1-800-634-4350 or go to omronhealthcare.com.
The life of the pads may vary by how often you wash the pads, the skin condition, and how you store the pads.
When should you replace your pads?
If the pad no longer sticks to your skin or if more than 25% of the pad’s surface is not in contact with your skin.
Cleaning the unit
1. Turn unit off and disconnect the electrode cords from the pads.
2. Clean with a lightly moistened cloth (or a cloth soaked in a neutral cleaning solution) and wipe gently.
• Do not use chemicals (like thinner, benzene).
• Do not let water get into the internal area.
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.
• Do not keep in areas subject to direct sunlight, high or low temperatures, humid area, near to fi re, vibration, or shock.
Storage temperature, 32°F - 104°F (0°C - 40°C), 30% - 80% relative humidity.
• Do not keep at places that can be easily reached by children.
• When not in use for a long period, remove the batteries before storage, to avoid liquid discharge from batteries.
• Do not wrap the electrode cords around the unit because it may damage the cord.
TROUBLESHOOTING
If this happens... Possible causes... Try this solution...
The intensity is not felt.
Very weak intensity
level.
Are you using only 1 pad? Put the other pad on your skin. You must use BOTH PADS
for therapy to work.
Have you removed the transparent fi lm from the
pad?
Peel off fi lm on the adhesive surface of pads.
Are the pads stacked together or do pads
overlap?
Check placement of pads. Refer to Pad Placement Guide.
Is the cord properly connected to the unit? Connect cord plug correctly into the jack at bottom of this
unit.
Is the intensity setting getting weak? Press the ▲(Up) button.
Is the gel damaged? Replace pad.
Are the batteries weak? Replace both AAA batteries.
Is the intensity “1”? Press the ▲(Up) button.
The skin turns red or the
skin feels irritated.
Is the adhesive surface of pads dirty or dry?
Wash adhesive surface of pads softly with your fi ngertips for about 3
seconds under slow running water.
Is therapy time too long? Use less than 15 minutes.
Are the two pads attached properly to the
body?
Refer to the Pad Placement Guide and attach correctly.
Is the pad surface worn out? Replace both pads at the same time.
No power source. Are the polarities of battery (+ and -) aligned
in the wrong direction? or Are the batteries
depleted?
Check batteries for correct alignment. or Replace batteries.
Power cut off during use. Are the batteries weak? Replace both batteries at the same time.
Is the cord broken? Replace cord.
Battery Light lights up.
Are the batteries weak? Replace both batteries at the same time.
Pad gel does not stick to
skin.
Have you removed the transparent fi lm from the pad? Peel off fi lm on the adhesive surface of pads.
Is the pad wet? or Is your skin too wet? Dry the pad. or Dry the skin.
The pad gel may be damaged. Replace the pad.
Is there too much hair on your skin?
Shave the immediate area for proper pad adhesion.
Is the adhesive surface of pads dirty or dry? Wash adhesive surface of pads softly with your fi ngertips for
about 3 seconds under slow running cold water.
Are you using pad during perspiring? Dry the pad placement area.
Have the pads been washed too long and/ or
too frequently?
Leave the pad in freezer for overnight.
Were the pads stored under high temperature,
high humidity, or direct sunshine?
Replace both pads.
Pad Light is blinking. Are both pads attached to the body? Re-attach dislocated pad(s) onto the skin fi rmly.
Have you removed the transparent fi lm from the pad? Peel off fi lm on the adhesive surface of pads.
Is the cord properly connected to the main
unit?
Connect cord plug correctly into the jack at the bottom of the
main unit.
Is the adhesive surface of pads dirty or dry? Wash adhesive surface of pads softly with your fi ngertips for
about 3 seconds under slow running cold water.
If the above measures are not effective, contact us at 1-800-634-4350.
LIMITED WARRANTY
Your OMRON®Pocket Pain Pro™ unit, excluding the batteries, 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. 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. Replacement is our only responsibility and your only remedy under the above warranties.
To obtain warranty service, contact Customer Service by calling 1-800-634-4350 for the address of the Inspection Center and
shipping and handling charges that may apply. Enclose the Proof of Purchase. Include a letter, with your name, address, phone number,
and description of the specifi c problem. Pack the product carefully to prevent damage in transit. Because of possible loss in transit, we
recommend insuring the product with return receipt requested.
THIS WARRANTY GIVES YOU SPECIFIC LEGAL RIGHTS, AND YOU MAY HAVE OTHER RIGHTS THAT VARY FROM STATE
TO STATE (OR BY COUNTRY OR PROVINCE). THE FOREGOING IS THE SOLE WARRANTY PROVIDED BY OMRON IN
CONNECTION WITH THIS PRODUCT, AND OMRON HEREBY DISCLAIMS ANY OTHER WARRANTIES, EXPRESS OR IMPLIED,
INCLUDING IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. IMPLIED
WARRANTIES AND OTHER TERMS THAT MAY BE IMPOSED BY LAW, IF ANY, ARE LIMITED IN DURATION TO THE PERIOD
OF THE ABOVE EXPRESS WARRANTY.
SOME STATES (COUNTRIES AND PROVINCES) DO NOT ALLOW LIMITATIONS ON HOW LONG AN IMPLIED WARRANTY
LASTS, SO THE ABOVE LIMITATION MAY NOT APPLY TO YOU. OMRON SHALL NOT BE LIABLE FOR LOSS OF USE OR
ANY OTHER SPECIAL, INCIDENTAL, CONSEQUENTIAL OR INDIRECT COSTS, EXPENSES OR DAMAGES. SOME STATES
(COUNTRIES AND PROVINCES) DO NOT ALLOW THE EXCLUSION OR LIMITATION OF INCIDENTAL OR CONSEQUENTIAL
DAMAGES, SO THE ABOVE EXCLUSION OR LIMITATION MAY NOT APPLY TO YOU.
This warranty provides you with specifi c legal rights, and you may have other rights that vary by jurisdiction. Because of special local
requirements, some of the above limitations and exclusions may not apply to you.
FOR CUSTOMER SERVICE
Visit our web site at: omronhealthcare.com
Call toll free: 1-800-634-4350
SPECIFICATIONS
Product Name OMRON®Pocket Pain Pro™
Model # PM3029
Power Source DC3V (two AAA alkaline batteries or two AAA manganese batteries)
Battery Life
New batteries (two AAA alkaline batteries) will last for approx. 3 months (when used for
15 minutes a day, Lower Back Mode, max. intensity).
Frequency Approx. 1 to 108Hz
PULSE Duration 100 μsec
Maximum Output Voltage 32V (during 500Ω load)
Power Control 10 intensity levels
Operating Temperature, Humidity (When using product) 50°F to 104°F (10 °C to 40 °C), 30 to 80% RH
Storage Temperature, Humidity 32°F to 104°F (0 °C to 40 °C), 30 to 80% RH
Transportation Temperature, Humidity, Air Pressure -4°F to 140°F (-20 °C to 60 °C), 10 to 95% RH, 700 to 1060 hPa
Weight Approx. 75g (incl. batteries)
Outer Dimension Approx. Width 75mm x Height 70mm x Depth 22mm
Classifi cation of ME equipment Internally powered
IP classifi cation IP 22*
NOTE: • These specifi cations are subject to change without notice.
• This OMRON product is produced under the strict quality system of OMRON HEALTHCARE Co. Ltd., Japan.
Designed for a minimum of 5 years life expectancy.
= This shows the Type BF applied part. * Protection against ingress of an object of φ12.5 mm or more. Protection against
the ingress of vertically falling water drips with the device tilted at 15 degrees.
Accessories/replacement parts (To order : omronhealthcare.com)
• PMLLPAD (2.5”x4”) • Plastic Pad Holder-Standard • Electrode Cords
FCC STATEMENT
FCC CAUTION
Changes or modifi cations 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. This equipment generates, uses and can radiate
radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications.
However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or
television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or
more of the following measures:
• Reorient or relocate the receiving antenna.
• Increase the separation between the equipment and receiver.
• Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
• Consult the dealer or an experienced radio/TV technician for help.
This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful
interference, and (2) this device must accept any interference received, including interference that may cause undesired operation of this device.
IMPORTANT INFORMATION REGARDING ELECTRO MAGNETIC COMPATIBILITY (EMC)
With the increased number of electronic devices such as PC’s and mobile (cellular) telephones, medical devices in use may be susceptible to
electromagnetic interference from other devices. Electromagnetic interference may result in incorrect operation of the medical device and create a
potentially unsafe situation.
Medical devices should also not interfere with other devices.
In order to regulate the requirements for EMC (Electro Magnetic Compatibility) with the aim to prevent unsafe product situations, the IEC60601-
1-2 standard has been implemented. This standard defi nes the levels of immunity to electromagnetic interferences as well as maximum levels of
electromagnetic emissions for medical devices.
Medical devices manufactured for OMRON Healthcare conform to this IEC60601-1-2:2007 standard for both immunity and emissions.
Nevertheless, special precautions need to be observed:
• The use of accessories and cables other than those specifi ed by OMRON, with the exception of cables sold by OMRON as replacement parts for
internal components, may result in increased emission or decreased immunity of the device.
• The medical devices should not be used adjacent to or stacked with other equipment. In case adjacent or stacked use is necessary, the medical device
should be observed to verify normal operation in the confi guration in which it will be used.
• Do not use mobile (cellular) telephones and other devices, which generate strong electrical or electromagnetic fi elds, near the medical device. This may
result in incorrect operation of the unit and create a potentially unsafe situation. Recommendation is to keep a minimum distance of 7 m. Verify correct
operation of the device in case the distance is shorter.
The PM3029 is intended for use in the electromagnetic environment specifi ed below. The customer or the user of the PM3029 should assure that it is
used in such environment.
Electromagnetic emissions IEC60601-1-2
Emissions test Compliance Electromagnetic environment - guidance
RF emissions CISPR 11 Group 1 The PM3029 uses RF energy only for its internal function. Therefore, its RF emissions
are very low and are not likely to cause any interference in nearby electronic
equipment.
RF emissions CISPR 11 Class B The PM3029 is suitable for use in all establishments, including domestic
establishments and those directly connected to the public low-voltage power supply
network that supplies buildings used for domestic purposes
Harmonic emissions
IEC 61000-3-2
not applicable
Voltage fl uctuations/ fl icker
emissions IEC 61000-3-3
not applicable
Electromagnetic immunity IEC60601-1-2
Immunity test IEC 60601 Test level Compliance level Electromagnetic environment –guidance
Electrostatic discharge
(ESD) IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floor should be wood, concrete, or ceramic tile. If fl oors are
covered with synthetic material, the relative humidity should
be at least 30 %.
Electrical fast transient/
burst IEC 61000-4-4
±2 kV for power
supply lines
±1 kV for input/
output lines
Not applicable Not applicable
Surge IEC 61000-4-5 ±1 kV line(s) to line(s)
±2 kV line(s) to earth
Not applicable Not applicable
Voltage dips, short
interruptions and voltage
variations on power
supply input lines
IEC 61000-4-11
<5 % UT(>95 % dip inUT)
for 0,5 cycle
40 % UT(60 % dip in UT)
for 5 cycles
70 % UT(30 % dip in UT)
for 25 cycles
<5 % UT(>95 % dip in UT)
for 5 s
Not applicable Not applicable
Power frequency (50/
60 Hz) magnetic fi eld
IEC 61000-4-8
3 A/m 3 A/m Power frequency magnetic fi elds should be at levels
characteristic of a typical location in a typical commercial or
hospital environment.
Note: UTis the A.C. mains voltage prior to application of the test level.
Electromagnetic immunity IEC60601-1-2
Immunity test
IEC 60601 Test level Compliance level Electromagnetic environment –guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 V rms
150 kHz to 80 MHz
3 V/m
80 MHz to 2.5 GHz
3 V rms
3 V/m
Portable and mobile RF communications equipment should be used no
closer to any part of the PM3029 including cables, than the recommended
separation distance calculated from the equation appropriate to the
frequency of the transmitter.
Recommend separation distance
d= 1.2 150 kHz to 80 MHz
d= 1.2 80 MHz to 800 MHz
d= 2.3 800 MHz to 2.5 GHz
where Pis the maximum output power rating of the transmitter in watts
(W) according to the transmitter manufacturer and d is the recommended
separation distance in meters (m).
Field strengths from fi xed RF transmitters as determined by an
electromagnetic site survey,*2) should be less than the compliance level in
each frequency range.*3)
Interference may occur in the vicinity of
equipment marked with the following symbol:
Note1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and refl ection from
structures, objects, and people.
*2) Field strengths from fi xed transmitters, such as base stations for radio (cellular/ cordless) telephones and land mobile radio, AM and
FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due
to fi xed RF transmitters, an electromagnetic site survey should be considered. If the measured fi eld strength in the location in which
the PM3029 is used exceeds the applicable RF compliance level above, the PM3029 should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the PM3029.
*3) Over the frequency range 150 kHz to 80 MHz, fi eld strengths should be less than 3 V/m.
Recommended separation distance between portable and mobile RF communications equipment and the PM3029
The PM3029 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customers or
the users of the PM3029 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile
RF communications equipment (transmitters) and the PM3029 as recommended below, according to the maximum output power of the
communications equipment.
Output Power of
Transmitter in Watt
Separation distance according to frequency of transmitter in meter
150 kHz to 80 MHz
d = 1.2
80 MHz to 800 MHz
d = 1.2
800 MHz to 2.5GHz
d = 2.3
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated
using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W)
according to the transmitter manufacturer.
Note1: At 80MHz and 800MHz, the separation distance for the higher frequency range applies.
Note2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and refl ection from
structures, objects, and people.
Manufactured for : 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
© 2017 OMRON HEALTHCARE, INC. Made in China
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