Omron PM3031 Pain Relief Pro TENS Unit Instructions / Assembly

 TABLE OF CONTENTS
Before Using the Unit
Introduction 2
Important Safety Precautions and Warnings 3
How Pain Relief Pro Works 10
Know Your Unit 11
Package Contents 11
Features 12
Buttons and Their Functions 12
Operating Instructions
Assembly Steps 13
Step 1 — Insert Batteries 13
Step 2 — Attach Electrode Cord to the Unit......................... 14
Step 3 — Attach Pads to the Electrode Cord ........................ 14
Step 4 — Snap Either Electrode Cord to Each of the Pads...15
Step 5 — Attach the Unit to the Belt Clip............................ 15
Get Started With Your Therapy 16
Step 1 — Pad Placement 16
Step 2 — Select 1 of 8 Modes 19
Step 3 — Select the Correct Intensity Level (1 Low — 10 High)..22
How to Control and Reduce Your Pain 23
When Should the Unit be Used? 23
Get to Your Pain Early 23
How Long Should You Use It? 23
When to Stop Using the Unit? 23
What Type of Pain is It Best For? 24
Cleaning and Storing
Cleaning and Storage 25
Cleaning the Pads 25
When Should You Replace Your Pads? 25
Cleaning the Unit 26
Storing the Pads 26
Storing the Unit and the Pads 26
Troubleshooting 27
Limited Warranty 30
Specifications 32
FCC Statement 33
Important Information Regarding Electro Magnetic
Compatibility (EMC) 34
INTRODUCTION
Thank you for purchasing the Omron® Pain Relief Pro™
Model PM 3031.
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.
* Register your product on-line at www.register-omron.com.
+ Keep your purchase receipt as proof of purchase for
warranty coverage.
The Omron” Pain Relief Pro solution is intended for the relief of
pain associated with sore or aching muscles of the lower back,
arms, legs, feet, or joints due to strain from exercise or normal
household and work activities. It should be applied to normal,
healthy, dry, clean skin of adult patients.
This box contains the following components:
* Unit
Electrode Cords
Two Self-Adhesive Pads
Pad Holder
Two AAA Batteries
Belt Clip
Soft Pouch
Instruction Manual
* Quick Start Guide with Pad Placement Guide
SAVE THESE INSTRUCTIONS
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
Improper use may cause danger resulting in
A DANGER death or serious injury.
Indicates a potentially hazardous situation
A WARNING which, if not avoided, could result in death or
serious injury.
Indicates a potentially hazardous situation
A CAUTION which, if not avoided, may result in minor or
moderate injury to the user or patient or
damage to the equipment or other property.
A DANGER
This unit must not be used in combination with the
following medical devices:
(1) Internally transplanted electronic medical devices, Y
such as a pacemaker.
(2) Electronic life support equipment, such as respirators.
(3) Electronic medical devices attached to the body, such
as electrocardiographs.
Using this unit with other electronic medical devices may
cause erroneous operation of those devices.
IMPORTANT SAFETY PRECAUTIONS AND WARNINGS
DO NOT USE THIS UNIT UNDER THESE CONDITIONS
A\ Consult with your physician before using this unit.
The unit may cause lethal rhythm disturbances in
certain susceptible individuals.
À 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.
À Together with a life-supporting medical electronic device
such as an artificial heart or lung or respirator.
À In the presence of electronic monitoring equipment (e.g.,
cardiac monitors, ECG alarms), which may not operate properly
when the electrical stimulation device 1s in use.
À On open wounds or rashes, or over swollen, red, infected, or
inflamed areas or skin eruptions (e.g., phlebitis, thhombophlebitis,
varicose veins); On top of, or in proximity to, cancerous lesions.
À Over areas of skin that lack normal sensation.
A\ On the opposite sides of your head since the effects of
stimulation of the brain are unknown.
A\ Use caution if stimulation is applied over areas of skin that lack
normal sensation.
A\ 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.
Á Operation in close proximity (e.g.1 m) to a shortwave or
microwave therapy ME EQUIPMENT may produce instability
in the STIMULATOR output.
DO NOT USE ON THESE INDIVIDUALS
A\ Pregnant women, because the safety of electrical stimulation
during pregnancy has not been established.
Á Children or infants, because the unit has not been
evaluated for pediatric use.
A\ Persons incapable of expressing their thoughts or intentions.
A\ Persons incapable of operating the unit by themselves.
À Use caution if you have a tendency to bleed internally, such as
following an injury or fracture.
IMPORTANT SAFETY PRECAUTIONS AND WARNINGS
A\ Consult with your physician prior to using the unit after a
recent surgical procedure, because stimulation may disrupt the
healing process.
A\ Use caution if stimulation is applied over the menstruating or
pregnant uterus.
A\ Keep unit out of the reach of young children. The electrode
cord can cause strangulation.
DO NOT USE THIS UNIT DURING THESE ACTIVITIES
À When in the bath or shower;
A While sleeping;
A While driving, operating machinery, or during any activity
in which electrical stimulation can put you at risk of injury.
Á NEVER APPLY THE PADS TO:
ON Both sides of the thorax
XR jhe head or any arca of (N) simultaneously (lateral
or front and back),
The neck or any area
O of the throat because
or across your chest
because the introduction
this could cause severe
muscle spasms resulting
N of electrical current
Y
in closure of the airway,
O
ÚS may cause rhythm
7 disturbances which
could be lethal.
difficulty in breathing,
or adverse effects on Do not use near the heart,
heart rhythm or blood above from the neck, the head,
pressure. mouth, genital area.
IMPORTANT SAFETY PRECAUTIONS AND WARNINGS
PAIN MANAGEMENT WARNINGS
À If you have had medical or physical treatment for your pain,
consult with your physician before using this unit.
À If your pain does not improve, becomes seriously chronic or
severe, or continues for more than five days, stop using the
unit and consult with your physician.
Á The mere existence of pain functions as a very important
warning telling us that something 1s wrong. Therefore, 1f you
suffer from any serious illness, consult your physician in
order to confirm that it is advisable for you to use this
Pain Relief Pro unit.
WARNINGS WHILE USING UNIT
Á Do not use another TENS device with this product
simultaneously.
A\ Do not plug this cord into any other device that is not an
Omron PM 3031.
Á No modification of this unit is allowed.
WARNINGS AND PRECAUTIONS REGARDING THE PADS
A\ Apply pads to normal, healthy, dry, clean skin (of adult
patients) because it may otherwise disrupt the healing process.
A\ If you experience any skin irritation or redness after a
session, do not continue stimulation in that area of the skin.
/\ Do not bend or fold because the pad may not function properly.
Store on either side of the plastic pad holder when not in use.
À 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.
À To avoid damage to the adhesive surface of the pads, put the
pads only on the skin or on the plastic pad holder provided
to avoid damage to the adhesive surface of the pads.
/\ Place the pads at least 1 inch apart on your skin. The pads
should never touch each other.
À Always place clean pads in accordance with illustrations
provided (Refer to pages 16-18, Pad Placement).
IMPORTANT SAFETY PRECAUTIONS AND WARNINGS
Á Make sure the components are connected well and the pads
are fixed on the part of the body you wish to treat or the
therapy may not be effective.
DO NOT USE YOUR PADS IN THE FOLLOWING WAY
A\ Pads should not touch each other when placed onto your skin.
À Do not place on your spine or backbone.
Á Pad should not touch any metal object, such as a belt buckle,
necklace, or other metal worn under clothing.
Á Pads should not be placed simultaneously on the soles of
both feet.
Á Pads should not be placed simultaneously on the calves of
both legs.
/\ Do not share pads with another person. This may cause a skin
irritation or infection. Pads are intended for use by one person.
Á Do not place or relocate the pads while the unit is on.
Á Always turn the power off before removing or changing the
pad location.
À Do not leave pads attached to the skin after treatment.
IMPORTANT SAFETY PRECAUTIONS AND WARNINGS
CAUTION WHILE USING UNIT
À\ 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.
À\ Do not insert the electrode plug into any place other than
the jack on the unit.
À Do not mix alkaline and manganese batteries as this will
shorten the battery life.
Do not pull on the electrode cord during treatment.
Do not use the unit while wearing electronic devices such
as watches as this may damage the unit.
Do not use near a cell phone as this may cause the stimulator
to malfunction.
À\ Do not bend or pull the end of the cord.
/\ When pulling out the cord from the unit, hold the plug and pull.
Á Replace the cord when broken or damaged.
Л\ Ро not throw the batteries into a fire. The batteries may explode.
/A Do not use the unit without proper lighting. You may not be
able to operate unit successfully.
/\ Dispose of the unit, batteries, and components according
to applicable legal regulations. Unlawful disposal may cause
environmental pollution.
Á The size, shape and type of pads may affect the safety and
effectiveness of electrical stimulation.
Á The electrical performance characteristics of pads may
affect the safety and effectiveness of electrical stimulation.
Using pads that are too small or incorrectly applied, could
result in discomfort or skin burns.
Á Do not place in a room with high humidity, such as a
bathroom. This will damage the unit.
A 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.
A Detach the pads before replacing the batteries.
During therapy, do not remove the battery cover and do not touch
the battery terminals.
IMPORTANT SAFETY PRECAUTIONS AND WARNINGS
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.
A\ TENS is a symptomatic treatment and, as such, suppresses
the sensation of pain that would otherwise serve as a
protective mechanism.
A\ Effectiveness is highly dependent upon patient selection by a
practitioner qualified in the management of pain patients.
Á You may experience skin irritation or hypersensitivity due
to the electrical stimulation or electrical conductive medium
(gel).
Á Keep unit away from young children. The unit contains
small pieces that may be swallowed. Immediately contact
your physician.
A\ Use this unit only with the leads, electrodes, and accessories
recommended by the manufacturer to avoid damage to the unit.
Possible Adverse Reactions
A\ You should stop using the unit and consult with your
physician if you experience adverse reactions from the unit.
À You may experience skin irritation and burns beneath the
stimulation electrodes applied to your skin.
A\ 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.
A 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 PAIN RELIEF PRO WORKS
What is it? How does it work?
The OMRONP® Pain Relief Pro™ unit is a portable device designed Scientific theory suggests that electrical stimulation therapy may
for adults only. It is designed to reduce and relieve muscle and work in several ways:
joint pain, stiffness and numbness in the arms, legs and foot by
applying electrical nerve stimulation to the surface of the skin 1. The gentle electrical pulses move through the skin to nearby
near the site of the pain. It can be successfully used in conjunction nerves to block or shut out the pain message from ever
with any other pain treatment or medication. reaching the brain from the source of the pain.
This type of therapy, called Transcutaneous Electrical Nerve 2. The gentle electrical pulses increase the production of the
Stimulator (TENS), has been used for over 30 years by medical body's natural pain killer, such as endorphins.
professionals such as physical therapists and chiropractors.
3. Furthermore, it is thought that the electrical stimulation
improves blood circulation as well. Muscles contract and relax
with the flow of the electrical stimulation. With repeated
contracting and relaxing, the blood flows in and out and the
blood circulation is improved.
10
KNOW YOUR UNIT
PACKAGE CONTENTS
Unit Electrode Cords Pad Holder Two Self-
Adhesive Pads
= (2.5” х 4”)
r Y
EZ
Batteries for trial use
(two AAA size (LRO3) batteries) ФЕ el
Instruction Manual Quick Start Guide/ Belt Clip Soft Pouch
Pad Placement Guide
В ae! J
11
KNOW YOUR UNIT
FEATURES BUTTONS AND THEIR FUNCTIONS
1. Eight pre-set modes (Arm, Lower Back,
2 Tee Too Jom L oe eo) h) Pad Icon / omron \ Battery Icon
' en Ensity 1evels ow to 80. If the pad dislodges, the pad = моё СВУ If the battery is low, the battery
3. Pair of pads (durable, re-usable, washable, icon will come on. icon will display.
up to 150 uses). «es a : Battery is close to low.
(Only use OMRON manufactured pads or Intensity Level С В IC 2 © : Battery is low.
cords with this unit). (mr vier J | Minutes remaining of therapy
4. Automatic 15 minute shut off. REET Mode Button
5. Big screen lets you clearly control your therapy Intensitv Butt a) (ove | == Select one of the eight pre-set modes
with mode, intensity level and minutes left. Se oy ding to your needs v)) (nr) — that fees good on your pain. Mode
: : : . ; € WIll SNOW On SCreen.
6. Low battery icon displays to remind you Press A for higher intensity. intensity POWER typ
to replace the batteries. Press V for lower intensity. ды Power Button
7. Pad icon displays if pad falls off.
Push once for “ON” and again for
“OFF”.
Cord Jack
12
ASSEMBLY STEPS
STEP 1 - INSERT BATTERIES
1 Remove the battery cover on the back using a coin. 3 Reinstall the battery cover.
Tighten with a coin.
2 Insert batteries. Make sure the Y O signs correspond when
inserting batteries.
cs C
— Battery Cover
13
ASSEMBLY STEPS
STEP 2 - ATTACH ELECTRODE CORD STEP 3 - ATTACH PADS TO THE
TO THE UNIT ELECTRODE CORD
Attach the electrode cord plug to the bottom of the unit. For the first time, take the pads out of the sealed package and
remove the clear plastic film from the back of the pad. Discard
\ 7 ) the plastic film backing as well as the clear packaging.
\
y (When not using the unit, turn the unit off and keep the electrodes
connected to pads. Place pads onto sides of plastic holder and
wrap cord around holder and store in a dry, cool location. Refer to
4 page 26.)
ASSEMBLY STEPS
STEP 4 - SNAP EITHER ELECTRODE CORD TO STEP 5 - ATTACH THE UNIT TO THE BELT CLIP
EACH OF THE PADS
Ji
Q
NOTE: \ 7
Pads will not stick 1f the skin has too much hair. We recommend Á The clip may fall off if attached to soft or thin clothing.
shaving the area for effective treatment. 15
GET STARTED WITH YOUR THERAPY
(USE FOR A MAXIMUM OF 30 MINUTES PER SESSION)
STEP 1 - PAD PLACEMENT
Place pads on clean, dry and healthy skin near the
area with pain. Place the pads near or surrounding
the pain. Make sure there is a linear path between
the two pads. Refer to the Pad Placement Guide
Insert or use the following illustrations.
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
LOWER BACK
Attach both pads on the lower back
complete. . .
according to your pain.
À Place the pads at least 1” apart on your skin. Л\ Do not place pads on the
The pads should never touch each other. backbone or spine.
16
GET STARTED WITH YOUR THERAPY
STEP 1 - PAD PLACEMENT (continued)
/
\ 7
SCIATIC DELTOID UPPER ARM ELBOW HIP & THIGH
Attach one pad below Attach one pad in front Attach both pads on Attach both pads on Attach both pads on
and above the region in and one in back of the either side of the region either side of the joint either side of the area
pain, both on same side muscle. where you feel pain. with the pain. with pain.
(NOT on spine).
17
GET STARTED WITH YOUR THERAPY
STEP 1 - PAD PLACEMENT (continued)
Inside
KNEE CALF ANKLE/FOOT
Attach both pads above the knee Attach both pads on the calf where you feel Attach pads per the illustration, on the left for
or above and below the joint pain. pain on the outside of your ankle/foot. Attach
with pain. Á Pads should not be placed simultaneously the pads per the illustration on the right for
on the calves of both legs. pain on the inside of your ankle/foot.
18
GET STARTED WITH YOUR THERAPY
STEP 2 - SELECT 1 OF 8 MODES
» Push “ON/OFF”.
* Personalize your therapy by pushing the mode button to select
the mode for your pain.
How do you switch modes?
Each time you push the mode button, it switches to the next mode
at the lowest intensity level. Depending on the mode, you will
feel a gentle combination of pulsing sensations that vary in pulse
1. Tapping speed.
2. Kneading
3. Rubbing How to select the right mode
4. Arm Select the mode that feels right for your unique pain. The modes
5. Lower Back are interchangeable and may be used for more than one body part.
6. Leg
7. Foot
8. Joint
19
GET STARTED WITH YOUR THERAPY
STEP 2 - SELECT 1 OF 8 MODES (continued)
Arm Lower Back Leg
Cilo ETT
(T]p )Ginead)(Rub (Tan Nad Cron) (Tan Vea RIE)
5 IE (Top Xinj od Rub ) (Top nee RIB
\ NE Ari==1LBack)==eg ) {Arm XLBa==( Leg ) =
Ve Хето An) Bec ea y ат ЛЕ) 99
bt Joint 4 Foot % Jelnt (Foot Y Joim%, I
Therapies designed for Upper € Lower Arm Lower Back Leg, Hip & Thigh
Potential conditions Swelling, stiffness, sore or achy,
muscle or nerve pain.
Stiffness, soreness, muscle spasm,
nerve pain.
Swelling, fatigue, stiffness, muscle
or nerve pain.
What does the therapy deliver? | Series of low to medium rate tapping,
tingling and pulsing sensations.
Series of high rate to low tingling
sensations, followed by tapping.
With higher intensity, you may feel
kneading or massage sensations.
Series of low to medium tapping and
rubbing sensations.
20
GET STARTED WITH YOUR THERAPY
STEP 2 - SELECT 1 OF 8 MODES (continued)
Foot Joint Tap Knead Rub
lz NS 4 s_L/
{ Tap M Knead и Rub ; { Tap MM Knead){ Rub ; =={ Tap у е== Рай и Rub ) { Ta==" Kneady—=ub } | Tap M Kne== Rub )
Ат \6-Васк\ Leg } { Arm<{LE[ck\$ Leg ) 4 "Ап № Back Leg } { Arm% LEI ckN Leg } (Arm X Bac’ Llg >
N An Back Leg ; Ат а СВ] ско Leg y LAIN Sac 9 LOMO tes vam Bac tig y
— Foot Mint ; | Рош Joint ) { Foot м: Joint } { Foot he Joint ; | Foot и Joint )
TN 7 EN
Therapies .
р Foot Joint Tap Knead Rub
designed for
sensations.
pulsing sensations.
mimic massage.
Potential Swelling, fatigue, chilly | Swelling, stiffness, sore | Stiffness, soreness, tight | Stiffness, sore or achy, Stiffness, sore or achy,
conditions feeling, sore or achy. or achy. feeling. knotty muscles, tight knotty muscles, tight
feeling. feeling.
What does the Series of low rate Series of medium to Series of low rate Series of medium rate Series of high rate
therapy deliver? | tapping, pulsing high rate tapping, tapping sensations. pulsing sensations to pulsing sensations to
mimic hands rubbing.
21
GET STARTED WITH YOUR THERAPY
STEP 3 - SELECT THE CORRECT INTENSITY LEVEL
(1 LOW - 10 HIGH)
Start at the lowest intensity level and slowly increase it by
pushing the “A (Up)” arrow button. You should feel a gentle
pulsing sensation.
How do I pick the right intensity level for my pain?
Each time you push “A (Up)” or “Y (Down)” arrow, it moves
to another level. If the stimulation sensation becomes weaker
or disappears, increase the intensity until it is restored. But, if
the sensation is at all uncomfortable, press the down arrow to
decrease the intensity.
* Press A for higher intensity.
* Press V for lower intensity.
22
How long is the therapy?
The unit will continue automatically for 15 minutes before it shuts
off.
The screen shows you how many minutes are remaining.
55
Intensity Minutes Left
Minutes left
out of 15 minutes
Intensity
Level
HOW TO CONTROL AND REDUCE YOUR PAIN
When should the unit be used?
Use as soon as your pain begins. Start with one session (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.
23
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 “On”
button to continue therapy for another 15 minute session.
1 session Max minutes/session Max times/day
15 minute 30 minutes or 3 times per day
automatic shut-off two sessions
See warnings on page 9. 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 five days.
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. It provides temporary relief or reduction of pain so
that you can control your life and activities better.
24
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 difficult to attach.
* Wash the pad softly with your
fingertips 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.
25
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 AND STORAGE
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 and place the pads on the pad
holder, one pad on each side.
4. Wrap the electrode cords around the
pad holder.
La
26
Storing the unit and pads
* Store the unit with the belt clip on.
Store the pads with the electrode cords
on the pad holder.
* Do not keep in areas subject to direct
sunlight, high or low temperatures,
humid area, near to fire, vibration,
or shock.
Store in a cool, dry place, 50°F - 104°F
(10°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.
<>
TROUBLESHOOTING
If this happens...
Possible causes...
Try this solution...
If this happens...
Possible causes...
Try this solution...
The intensity is not
felt.
Very weak intensity
level.
Are both pads Check placement of
attached to the body? | pads. Attach both
pads to the body.
Have you removed the | Peel off film on the
transparent film from
the pad?
adhesive surface of
pads.
Are the pads stacked | Check placement of
together or do pads pads. Refer to Pad
overlap? Placement Guide.
Is the cord properly Connect cord plug
connected to the unit?
correctly into the jack
at bottom of this unit.
Is the intensity setting
getting weak?
Press the A up
button.
27
The intensity 1s not
felt.
Very weak intensity
level.
Are the batteries weak?
Replace both AAA
batteries.
Is the intensity “1”?
Press the A up button.
The skin turns red or
the skin feels irritated.
Is the adhesive Wash adhesive
surface of pads dirty | surface of pads softly
or dry? with your fingertips
for about 3 seconds
under slow running
water.
Is therapy time Use less than
too long? 15 minutes.
Are the two pads Refer to the Pad
attached properly to Placement Guide and
the body? attach correctly.
TROUBLESHOOTING
No power source.
Are the polarities
of battery (+ and -)
Check batteries for
correct alignment.
К
aligned in the wrong Replace batteries.
direction? Are the
batteries depleted?
Power cut off Are the batteries Replace both batteries
during use. weak? at the same time.
Is the cord broken? Replace cord.
Battery icon is empty | Are the batteries Replace both batteries
or close to empty. weak? at the same time.
28
the pad?
If this happens... Possible causes... | Try this solution... If this happens... Possible causes... | Try this solution...
The skin turns red or | Is the pad surface Replace both pads at It is difficult to attach | Have you removed the | Peel off film on the
the skin feels irritated. | worn out? the same time. the pad to the skin. transparent film from | adhesive surface of
pads.
Was the pad applied Sufficiently dry the
immediately after skin surface.
washing?
Is the adhesive Replace the pad.
surface of the pad
damaged?
Is there too much hair | Shave the immediate
on your skin? area for proper pad
adhesion.
TROUBLESHOOTING
If this happens... Possible causes... | Try this solution... If this happens... Possible causes... | Try this solution...
Adhesive surface of Are you using pad Dry the pad placement Pad icon is displayed. | Have you removed the | Peel off film on the
pad is not sticky. during perspiring? area. PAD 2 transparent film from | adhesive surface of
9
Have the pads been Leave the pad in the pad? pads.
washed too long and/ | freezer for overnight. Is the cord properly Connect cord plug
or too frequently? connected to the unit? | correctly into the jack
Were the pads Replace both pads. at the bottom of the
stored under high -
temperature, high Is the adhesive Wash adhesive
humidity, or direct surface of pads dirty | surface of pads softly
sunshine? or dry? with your fingertips
Pad icon is displayed. | Are both pads Check placement of for about 3 seconds
under slow running
PAD 2 attached to the body? | pads to ensure they are water
on the body securely.
If the above measures are not effective, contact us at 1-800-634-4350.
29
LIMITED WARRANTY
Your OMRONS Pain Relief ProTM unit and electrode cords
are warranted for 1 year, excluding the batteries. The pads
supplied with the unit are warranted for 30 days. They are
guaranteed to be free from defects in materials and workmanship
if used in accordance with the instructions provided. 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 any
applicable shipping and handling. Enclose the Proof of Purchase.
Include a letter, with your name, address, phone number, and
description of the specific problem. Pack the product carefully to
30
prevent damage in transit. Because of possible loss intransit, we
recommend insuring the product with return receipt requested.
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.
OMRON SHALL NOT BE LIABLE FOR LOSS OF USE OR
ANY OTHER SPECIAL, INCIDENTAL, CONSEQUENTIAL
OR INDIRECT COSTS, EXPENSES OR DAMAGES.
LIMITED WARRANTY
This warranty provides you with specific 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
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SPECIFICATIONS
Humidity (When using product)
Battery Life New batteries (two AAA alkaline
batteries) will last for approx. 4 months
(when used for 15 minutes a day,
Lower Back Mode, max. intensity).
Frequency Approx. 1 to 108Hz
PULSE Duration 100 usec
Maximum Output Voltage | U <40V (during 500Q load)
Power Control 10 intensity levels
Operating Temperature, 50°F to 104°F (10 °C to 40 °C),
30 to 80% RH
Storage and Transportation
Temperature, Humidity,
Air Pressure
-4°F to 140°F (-20°C to 60°C), 10
to 95% RH, 700 to 1060 hPa
32
Product Name OMRON® Pain Relief ProTM Weight Approx. 100g (incl. batteries)
Model # PM3031 Outer Dimension Width 52mm x Height 112mm x
Power Source DC3V Depth 25mm
(two AAA alkaline batteries or Classification of ME equipment | Internally powered
two AAA manganese batteries) IP classification IP 22
This OMRON product is produced under the strict quality system
of OMRON HEALTHCARE Co. Ltd., Japan.
[#] = This shows the Type BF applied part.
Accessories/replacement parts
* PMLLPAD-L (3”x4.5”) » Plastic Pad Holder- * Belt Clip
* PMLLPAD (2.5”x4”) Large * Soft Pouch
* Electrode cords * Plastic Pad Holder-
Regular
To order : omronhealthcare.com
NOTE: These specifications are subject to change without notice.
FCC STATEMENT
NOTE: POTENTIAL FOR RADIO/TELEVISION
INTERFERENCE (for U.S.A. only)
This product has been tested and found to comply with the limits
for a Class B digital device, pursuant to part 15 of the FCC rules.
However, there is no guarantee that interference will not occur in a
particular installation. If the product does cause harmful interference
to radio or television reception, which can be determined by turning
the product on and off, the user is encouraged to try to correct the
interference by one or more of the following measures:
These limits are designed to provide reasonable protection against < Reorient or relocate the receiving antenna.
harmful interference in a residential installation. The product Increase the separation between the product and the receiver.
generates, uses, and can radiate radio frequency energy and, ifnot «e Connect the product into an outlet on a circuit different from
installed and used in accordance with the instructions, may cause that to which the receiver is connected.
harmful interference to radio communications. * Consult the dealer or an experienced radio/TV technician for help.
33
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
defines 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.
34
Nevertheless, special precautions need to be observed:
* The use of accessories and cables other than those specified
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 1s
necessary, the medical device should be observed to verify
normal operation in the configuration in which it will be used.
* Do not use mobile (cellular) telephones and other devices,
which generate strong electrical or electromagnetic fields, 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.
IMPORTANT INFORMATION REGARDING ELECTRO MAGNETIC COMPATIBILITY (EMC)
The PM3031 is intended for use in the electromagnetic environment specified below. The customer or the user of the PM3031 should
assure that it is used in such environment.
Electromagnetic emissions IEC60601-1-2
Emissions test Compliance Electromagnetic environment - guidance
RF emissions Group 1 The PM3031 uses RF energy only for its internal function. Therefore, its RF emissions are
CISPR 11 very low and are not likely to cause any interference in nearby electronic equipment.
RF emissions Class B The PM3031 is suitable for use in all establishments, including domestic establishments
CISPR 11 and those directly connected to the public low-voltage power supply network that supplies
. à buildings used for domestic purposes
Harmonic emissions not applicable
IEC 61000-3-2
Voltage fluctuations/ not applicable
flicker emissions
IEC 61000-3-3
35
IMPORTANT INFORMATION REGARDING ELECTRO MAGNETIC COMPATIBILITY (EMC)
Electromagnetic immunity IEC60601-1-2
Immunity test IEC 60601 Test level | Compliance level Electromagnetic environment —guidance
Electrostatic +6 kV +6 kV Floor should be wood, concrete, or ceramic tile. If floors are
discharge (ESD) contact contact covered with synthetic material, the relative humidity should
IEC 61000-4-2 +8 kV air +8 kV air be at least 30 %.
Electrical fast not applicable not applicable not applicable
transient/burst
IEC 61000-4-4
Surge not applicable not applicable not applicable
IEC 61000-4-5
Voltage dips, short not applicable not applicable not applicable
interruptions and
voltage variations on
power supply
IEC 61000-4-11
36
IMPORTANT INFORMATION REGARDING ELECTRO MAGNETIC COMPATIBILITY (EMC)
Electromagnetic immunity IEC60601-1-2
Immunity test IEC 60601 Test level | Compliance level | Electromagnetic environment —guidance
Power frequency (50/ | 3 A/m 3 A/m Power frequency magnetic fields should be at levels
60 Hz) magnetic field characteristic of a typical location in a typical commercial or
IEC 61000-4-8 hospital environment.
37
IMPORTANT INFORMATION REGARDING ELECTRO MAGNETIC COMPATIBILITY (EMC)
Electromagnetic immunity IEC60601-1-2
Immunity test IEC 60601 Test level | Compliance level Electromagnetic environment —guidance
Portable and mobile RF communications equipment should
be used no closer to any part of the PM3031 including cables,
than the recommended separation distance calculated from the
equation appropriate to the frequency of the transmitter.
Recommend separation distance
Conducted RF 3 V rms 3 Vrms d=12\P 150 kHz to 80 MHz
IEC 61000-4-6 150 kHz to 80 MHz d=12\P 80 MHz to 800 MHz
Radiated RF СМ М а=2.3 \/Р 800 MHz to 2.5 GHz
adiate m m ; ; ; ; ;
TEC 61000-4-3 80 MHz to 2.5 GHz where P 1s 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 fixed RF transmitters as determined
by an electromagnetic site survey,” should be less than the
compliance level in each frequency range.™
Interference may occur in the vicinity of (5)
equipment marked with he following symbol: “A
38
IMPORTANT INFORMATION REGARDING ELECTRO MAGNETIC COMPATIBILITY (EMC)
Electromagnetic immunity IEC60601-1-2
Immunity test | IEC 60601 Test level | Compliance level | Electromagnetic environment —guidance
Notel: 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 reflection from
structures, objects, and people.
> Field strengths from fixed 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 fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location
in which the PM3031 is used exceeds the applicable RF compliance level above, the PM3031 should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the PM3031.
"3 Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
39
IMPORTANT INFORMATION REGARDING ELECTRO MAGNETIC COMPATIBILITY (EMC)
Recommended separation distance between portable and mobile RF communications equipment and the PM 3031
The PM3031 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customers or the users of
the PM3031 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications
equipment (transmitters) and the PM3031 as recommended below, according to the maximum output power of the communications equipment.
Output Power of Separation distance according to frequency of transmitter in meter
Transmitter in Watt | 750 kHz to 80 MHz 80 kHz to 800 MHz 800 MHz to 2.5GHz
d=12\P =1.2\P d=2.3NP
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.
Note: At 80MHz and 800MHz, the separation distance for the higher frequency range applies
Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects, and people.
40
Manufactured for OMRON HEALTHCARE Co., Ltd.
Made in China
Distributed by:
OMRON HEALTHCARE, INC.
1925 West Field Court
Lake Forest, IL 60045 U.S.A.
omronhealthcare.com
© 2013 OMRON HEALTHCARE, INC.