Omron PM400 Pocket Pain Pro® TENS Unit Instruction manual

®
INSTRUCTION MANUAL
TENS Therapy Pain Relief
Pocket Pain Pro®
PM400
ENGLISH
Pads are for Single Patient Use Only
All for Healthcare
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
3
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 first 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
4
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
5
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.
6
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 artificial 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.
7
4. IMPORTANT SAFETY PRECAUTIONS AND WARNINGS
DO NOT USE ON THESE INDIVIDUALS
• Pregnant women.
•D
o 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:
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.
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
i n c l o s u r e o f t h e a i r w a y,
difficulty in breathing, or
adverse effects on heart rhythm
or blood pressure.
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.
Near the heart, or on genital
area.
Open wounds or rashes or over swollen, red, infected or inflamed 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.
8
4. IMPORTANT SAFETY PRECAUTIONS AND WARNINGS
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 five 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 confirm 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 modification 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.
9
4. IMPORTANT SAFETY PRECAUTIONS AND WARNINGS
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 fixed 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.
10
4. IMPORTANT SAFETY PRECAUTIONS AND WARNINGS
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 fire. 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.
11
4. IMPORTANT SAFETY PRECAUTIONS AND WARNINGS
• 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 qualified 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 specified 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.
12
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?
Scientific 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 flow of the electrical stimulation. With repeated contracting and relaxing, the blood
flows in and out and the blood circulation is improved.
13
6. KNOW YOUR UNIT
PACKAGE CONTENTS
Pocket Pain Pro Unit
Front
Back
Pad Holder (1 standard)
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
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.
14
6. KNOW YOUR UNIT
BUTTONS AND THEIR FUNCTIONS
Mode Light
Each light corresponds to a mode.
Intensity Light
(
[GET STARTED WITH
YOUR THERAPY] STEP 3)
Power Button
Press once for “ON” and again
for “OFF”.
(
[GET STARTED WITH
YOUR THERAPY] STEP 2 and
the Back of Main Unit)
Mode/Intensity Button
Select mode and intensity
according to your needs.
1. Press ▲/▼ to choose mode.
(
[GET STARTED WITH
YOUR THERAPY] STEP 2)
2. After selecting the mode:
Press ▲ for higher intensity.
Press ▼ for lower intensity.
(
[GET STARTED WITH
YOUR THERAPY] STEP 3)
Cord Jack
Pad Light
If the pad detaches, pad light will
blink.
(
[TROUBLESHOOTING])
Battery Light
If the battery is low, battery light
will light up.
Set/Start Button
After choosing the mode:
Press Set/Start to select the mode.
(
[GET STARTED WITH
YOUR THERAPY] STEP 2)
15
7. ASSEMBLY STEPS
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
1 Turn the unit over, and remove 2 Insert batteries.
the battery cover using a hard
Make sure the
object (such as the tip of a pen,
signs correspond when
thin screwdriver).
inserting batteries.
3 Reinstall the
battery cover.
STEP 2 – ATTACH ELECTRODE CORD TO THE MAIN UNIT
Attach the electrode cord plug to the bottom of the main unit.
16
7. ASSEMBLY STEPS
STEP 3 – SNAP EITHER ELECTRODE CORD TO EACH OF THE PADS
For the first 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 first time use, remove the clear plastic film from the back of
the pad.
Discard the plastic film backing as well as the clear packaging.
STORING PADS ON PAD HOLDER
Remove plastic film and put the sticky side of the pads on either side of the pad holder.
pad facing down
Pad Holder
pad sticky side up
17
8. GET STARTED WITH YOUR THERAPY
(USE FOR A MAXIMUM OF 30 MINUTES PER SESSION)
STEP 1 – PAD PLACEMENT
ARM
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
Attach both pads on either side of
pads.
the region where you feel pain.
• 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.
SHOULDER
Attach both pads on the shoulder
according to your pain.
Attach one pad on the front and on the back of
your 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.
18
8. GET STARTED WITH YOUR THERAPY
LOWER BACK
Attach both pads on the lower back according to your pain.
Place pads on muscle of back, not on spine, for optimal therapy.
LEG & FOOT
Attach one pad below
and above the region in
pain, both on same side.
Outside
Inside
(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.
19
(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.
8. GET STARTED WITH YOUR THERAPY
JOINT
(ELBOW)
(KNEE)
Attach both pads on either side of
the joint with the pain.
Attach both pads above the knee or
above and below the joint with pain.
STEP 2 – SELECT 1 OF 5 MODES
 Press
Power Button
 Mode
(Mode/Intensity Button)
 Press
Set/Start Button
j Press the Power button.
k Press the ▲(Up) or ▼(Down) button to choose 1 of the 5 modes.
Modes cannot be combined.
l 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
20
8. GET STARTED WITH YOUR THERAPY
How to change modes during therapy?
If you want to change modes during therapy, press the Set/Start button and the ▲(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
Arm/Shoulder
designed for
Mode Light
and the Back of
Main Unit
What does
the therapy
deliver?
Series of low to
high rate tapping,
pulsing, kneading
and massage-like
sensations.
Lower Back
Leg/Foot
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.
Knead
Steady
Series of medium rate
pulsing sensations to
mimic massage.
Series of regular
pulsing sensations that
do not change.
21
8. GET STARTED WITH YOUR THERAPY
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 the ▲(Up) button. You should feel a gentle pulsing sensation.
How do I select the right intensity level for my pain?
Each time you press the ▲(Up) or ▼(Down) button, it moves to another intensity level. If
the stimulation sensation becomes weaker or disappears, increase the intensity. But, if the
sensation is at all uncomfortable, press the ▼(Down) button to decrease the intensity.
• Press ▲ for higher intensity.
• Press ▼ for lower intensity.
If the pad light is blinking, the unit will automatically turn off after 30 seconds.
(
“TROUBLESHOOTING”)
What intensity level is my unit on?
Press the ▲(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.
22
9. 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 the unit off with the pads still on. Rate your
pain to check your progress, 1 low to 10 high. Stop your 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
CAUTION
• Excessive treatment and strong stimulation may cause muscular fatigue and may generate
adverse effects.
When to stop using the unit?
1. If you experience 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.
23
9. 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.
Before using, check to make sure all components are 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.
24
10. 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 of 1 time per 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 adhere.
• 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.
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 the 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.
25
10. CLEANING AND STORAGE
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 fire, vibration, or shock.
Storage temperature, 32 °F - 104 °F (0 °C - 40 °C), 30 % - 80 %
relative humidity.
• Do not keep in 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.
26
11. TROUBLESHOOTING
If any of the below problems occur, check to make sure that no other electrical device is within 12
inches (30 cm). If the problem persists, refer to the table below.
If this happens...
The intensity is not felt.
Very weak intensity level.
The skin turns red or the
skin feels irritated.
No power source.
Possible causes...
Are you using only 1 pad?
Try this solution...
Put the other pad on your
skin. You must use BOTH
PADS for therapy to work.
Have you removed the
Peel off film on the adhesive
transparent film from the pad? surface of pads.
Are the pads stacked together Check placement of pads.
or do pads overlap?
Refer to Pad Placement
Guide.
Is the cord properly
Connect cord plug correctly
connected to the unit?
into the jack at bottom of
this unit.
Is the intensity setting
Press the ▲(Up) button.
getting weak?
Is the gel damaged?
Replace pad.
Are the batteries weak?
Replace both AAA batteries.
Is the intensity “1”?
Press the ▲(Up) button.
Is the adhesive surface of
Wash adhesive surface
pads dirty or dry?
of pads softly with your
fingertips for about 3 seconds
under slow running water.
Is therapy time too long?
Use less than 15 minutes.
Are the 2 pads attached
Refer to the Pad Placement
properly to the body?
Guide and attach correctly.
Is the pad surface worn out? Replace both pads at the
same time.
Are the polarities of battery
Check batteries for correct
(+ and -) aligned in the wrong alignment or replace
direction? or Are the batteries batteries.
depleted?
27
11. TROUBLESHOOTING
If this happens...
Power cut off during use.
Possible causes...
Are the batteries weak?
Battery Light lights up.
Is the cord broken?
Are the batteries weak?
Pad gel does not stick to
skin.
Have you removed the
transparent film from the
pad?
Is the pad wet? or Is your
skin too wet?
The pad gel may be
damaged.
Is there too much hair on
your skin?
Is the adhesive surface of
pads dirty or dry?
Try this solution...
Replace both batteries at the
same time.
Replace cord.
Replace both batteries at the
same time.
Peel off film on the adhesive
surface of pads.
Dry the pad or dry the skin.
Replace the pad.
Shave the immediate area for
proper pad adhesion.
Wash adhesive surface
of pads softly with your
fingertips for about 3
seconds under slow running
cold water.
Dry the pad placement area.
Are you using pad during
perspiring?
Have the pads been washed Leave the pad in freezer for
too long and/ or too
overnight.
frequently?
Were the pads stored under
Replace both pads.
high temperature, high
humidity, or direct sunshine?
28
11. TROUBLESHOOTING
If this happens...
Pad Light is blinking.
Possible causes...
Are both pads attached to the
body?
Have you removed the
transparent film from the
pad?
Is the cord properly
connected to the main unit?
Try this solution...
Re-attach dislocated pad(s)
onto the skin firmly.
Peel off film on the adhesive
surface of pads.
Connect cord plug correctly
into the jack at the bottom of
the main unit.
Is the adhesive surface of
Wash adhesive surface
pads dirty or dry?
of pads softly with your
fingertips for about 3
seconds under slow running
cold water.
If the above measures are not effective, contact us at 1-800-634-4350.
29
12. LIMITED WARRANTY
Your OMRON Pocket Pain Pro unit, excluding the batteries and pads, 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 from the date of purchase. 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 specific 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 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
30
13. SPECIFICATIONS
Product Name
Model #
Power Source
Battery Life
Frequency
PULSE Duration
Maximum Output Voltage
Power Control
Operating Temperature, Humidity
(When using product)
Storage Temperature, Humidity
Transportation Temperature,
Humidity, Air Pressure
Weight
Outer Dimension
Classification of ME equipment
IP classification
Operation Mode
Applied Part
Durable period (Service Life)
OMRON Pocket Pain Pro
PM400 REF HV-F013-Z2
DC 3 V (2 AAA alkaline batteries or 2 AAA
manganese batteries)
New batteries (2 AAA alkaline batteries) will last for
approx. 3 months (when used for 15 minutes a day,
Steady Mode, max. intensity).
Approx. 1 to 108 Hz
100 μsec
32 V (during 500 Ω load)
10 intensity levels
50 °F to 104 °F (10 °C to 40 °C), 30 to 80 % RH
(non-condensing), 700 to 1060 hPa
32 °F to 104 °F (0 °C to 40 °C), 30 to 80 % RH
-4 °F to 140 °F (-20 °C to 60 °C), 10 to 95 % RH,
700 to 1060 hPa
Approx. 2.6 oz (75 g) (incl. batteries)
Approx. 3” (W) X 2.8” (H) X 0.9” (D) (75 X 70 X
22 mm)
Internally powered
IP 22
Continuous operation
Type BF (Pads)
Device: 5 years
Pad: 150 uses
NOTE: • These specifications 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.
IP classification is degrees of protection provided by enclosures in accordance with IEC
60529. This device is protected against solid foreign objects of diameter 12.5 mm such as
a finger and greater, and against oblique falling water drops which gives trouble to normal
operation.
31
13. SPECIFICATIONS
Accessories/replacement parts (To order : OmronHealthcare.com)
• PMLLPAD-L (3”x4.5” (75 mm × 114 mm))
• PMLLPAD (2.5”x4” (63 mm × 102 mm))
32
14. FCC STATEMENT
FCC CAUTION
Changes or modifications 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.
33
15. GUIDANCE AND MANUFACTURER’S DECLARATION
OMRON Pocket Pain Pro Information for Accompanying Documents in the Scope of
IEC60601-1-2:2014
Important information regarding Electromagnetic Compatibility (EMC)
PM400 conforms to IEC60601-1-2:2014 Electromagnetic Compatibility (EMC) standard.
Further documentation in accordance with this EMC standard is available at
OmronHealthcare.com/emc. Refer to the EMC information for PM400 on the website.
34
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
© 2019 OMRON HEALTHCARE, INC.
Made in China
HV-F013-Z2
4616057-0A