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.
1
m)
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
1
Turn the unit over, and remove the battery
cover using a hard object
(such as the tip of a pen, thin screwdriver).
2
Insert batteries.
Make sure the signs correspond
when 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.
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
