Omron electro Therapy Pocket Pain Pro Instruction Manual

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 Symbol 5.4.3
Medical Devices- Symbols to be used with Consult Instructions for Use
medical device labels, labelling and information Indicates that the manual must be consulted for proper use of a medical device.
to be supplied-Part 1 general guidelines
Table D.1 20
IEC 60601-1
Type BF applied part
Medical electrical equipment –Part 1: General
F-TYPE APPLIED PART complying with the specifi ed requirements of this
requirements for basic safety and essential
standard to provide a higher degree of protection against electric shock than that
performance
provided by TYPE B APPLIED PARTS
P007
ISO 7010
No access for people with active implanted cardiac devices
Graphical symbols -- Safety colours and safety
To prohibit people with active implanted cardiac devices from entering a
signs -- Registered safety signs
designated area
5140
Non-ionizing electromagnetic radiation
IEC 60417 To indicate generally elevated, potentially hazardous, levels of nonionizing
Graphical symbols for use on equipment 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 Symbol 5.1.6
Medical Devices- Symbols to be used with Catalogue number
medical device labels, labelling and information Indicates the manufacturer's catalogue number so that the medical device can
to be supplied-Part 1 general guidelines be identifi ed.
ISO 15223-1 Symbol 5.4.4
Medical Devices- Symbols to be used with Caution, consult accompanying documents
medical device labels, labelling and information Indicates that all documents be consulted for proper use of the device.
to be supplied-Part 1 general guidelines
ISO 15223-1 Symbol 5.1.4
Medical Devices- Symbols to be used with Use-by date
medical device labels, labelling and information Indicates the date after which the medical device is not to be used.
to be supplied-Part 1 general guidelines
Table D.3
IEC 60601-1
Symbol 2
Medical electrical equipment –Part 1: General
Ingress protection rating
requirements for basic safety and essential
Protection against ingress of an object of ¬12.5 mm or more. Protection against
performance
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
Improper use may cause danger resulting in death or serious injury. These are situations in which the device
DANGER
should not be used.
WARNING Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.
Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate a injury to the
CAUTION
user or patient or damage to the equipment or other property.
DANGER
Do not use this unit with these other devices:
(1) If you have a pacemaker, implanted defi brillator, or other implanted metallic or electronic device.
Such use could cause electric shock, burns, electrical interference or death.
(2) Do not use this device while using another TENS device.
(3) Together with a life-supporting medical electronic device such as an artifi cial heart or lung or respirator.
(4) For Hospitals and Clinics, in the presence of or when attached to the body, electronic monitoring equipment (e.g. cardiac monitors,
ECG alarms), which may not operate properly when the electrical stimulation device is in use.
(5) For Hospitals and Clinics, Simultaneous connection of a patient to a high frequency surgical ME equipment may result in burns at
the site of the stimulator electrodes and possible damage to the stimulator.
(6) For Hospitals and Clinics, operation in close proximity (e.g. 1m) to a shortwave or microwave therapy ME equipment may produce
instability to the stimulator output.
DO NOT USE THIS UNIT UNDER THESE CONDITIONS
Consult with your physician before using this unit.
The unit may cause lethal rhythm disturbances in certain susceptible individuals. If you have had a recent surgical procedure, the
stimulation may disrupt the healing process.
Before using your unit, inspect these things.
1. Cord is not broken.
2. Pad gel is not damaged.
3. Electrode cord connection is not broken.
4. Unit is intact and working.
5. There is no battery leakage.
DO NOT USE ON THESE INDIVIDUALS
Pregnant women.
Do not use on children or infants because this device has not been evaluated for pediatric use.
Keep out of the reach of young children because the electrode cord could cause strangulation.
Persons incapable of expressing their thoughts or intentions.
Persons incapable of operating the unit by themselves.
Use caution if you have a tendency to bleed internally, such as following an injury or fracture.
If you have suspected or diagnosed heart disease, you should follow precautions recommended by your physician.
If you have suspected or diagnosed epilepsy, you should follow precautions recommended by your physician.
Use caution if stimulation is applied over the menstruating uterus.
NEVER APPLY THE PADS TO THESE BODY AREAS:
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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.
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.
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.
PACKAGE CONTENTS
Pocket Pain Pro™ Unit
Front Back
Batteries
Both sides of the thorax simultaneously (lateral or
(two AAA size (LR03) batteries)
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.
FEATURES
1. Five pre-set modes (Arm/Shoulder, Lower Back, Leg/Foot, Knead, Steady).
2. Ten intensity levels (1 low to 10 high).
On the soles of both feet at the same time because this
may cause cardiac disturbance. 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
Mode Light
Each light corresponds to a mode.
( [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
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).
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.
Remove plastic fi lm and put sticky side of pads on either side of the pad holder.
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.
SHOULDER
It can be successfully used in conjunction with any other
Attach both pads on the shoulder according to
your pain.
KNOW YOUR UNIT
Electrode Cords 2 LONG LIFE PADS™ Pad Holder (1 standard)
(1 standard pair)
Instruction Manual (This Manual) Quick Start Guide /Pad Placement Guide
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Intensity Light
( [GET STARTED WITH YOUR THERAPY] STEP 3)
Power Button
Press once for "ON" and again for "OFF".
Pad Light
If the pad dislodges, 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)
(
ASSEMBLY STEPS
2 Insert batteries. 3 Reinstall the battery cover
Make sure the signs correspond
when inserting batteries.
STORING PADS ON PAD HOLDER
pad facing down
Pad Holder
pad sticky side up
GET STARTED WITH YOUR THERAPY
(USE FOR A MAXIMUM OF 30 MINUTES PER SESSION)
ARM
Attach both pads on either side of
the region where you feel pain.
Attach one pad on the front and on the back of your 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.
Continue to the back