iev
Pai
®
INSTRUCTION MANUAL
TENS Therapy Pain Relief
Total Power + Heat
TM
PM800
Pads are for Single Patient Use Only
2
Therapies
HEAT
Warms Muscles Relieves Pain
9
Modes
+
20
Power Levels
TENS
el
es
n
ENGLISH
TABLE OF CONTENTS
INTRODUCTION ...........................................................................................................................................3
IMPORTANT SAFETY INFORMATION ....................................................................................................4
HOW THE DEVICE WORKS ....................................................................................................................... 9
1. KNOW YOUR DEVICE ...........................................................................................................................10
2. PREPARATION ........................................................................................................................................12
3. GET STARTED WITH YOUR THERAPY .............................................................................................16
4. HOW TO CONTROL AND REDUCE YOUR PAIN .......................................................................... 27
5. MAINTENANCE ..................................................................................................................................... 28
6. TROUBLESHOOTING .......................................................................................................................... 30
7. OPTIONAL ACCESSORIES .................................................................................................................. 33
8. SPECIFICATIONS ................................................................................................................................... 34
9. FCC STATEMENT ................................................................................................................................... 35
10. LIMITED WARRANTY ........................................................................................................................ 36
11. GUIDANCE AND MANUFACTURER’S DECLARATION ............................................................ 37
2
INTRODUCTION
Thank you for purchasing the OMRON Total Power + H eat.
The OMRO N Total Power + Heat is a portable device t hat relieves chronic, acute* and art hritic
pain through the combination of soothing heat and TENS (Transcutaneous Electrical Nerve
Stimulation) technology. It is designed to reduce and relieve muscle and joint pain, stiness and
numbness in the back, arms, legs, shoulders and feet. The Total Power + Heat uses gel pads to
deliver TENS therapy to the surface of the skin for pain relief.
TENS is a safe and drug-free pain relief solution that has been used for over 40 years by medical
professionals such as physical therapists and chiropractors.
* Acute pain re fers to sore or achy m uscles due to strai n from exercise or no rmal househol d and work activi ties.
Safety Instructions
This instruction manual provides you with important information about this device. To ensure
the safe and proper use of this device, READ and UNDERSTAND all of these instructions. If you do
not understand these instructions or have any questions, contact 1-800-634-4350 before
attempting to use this device.
Intended Use
The OMRON Total Power + Heat 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 work activities. When used for the
symptomatic relief and management of chronic, intractable pain and relief of pain associated with
arthritis, use the Tap, Shoulder, Arm or Leg mode of stimulation.
Environments of Use: Clinics, hospital and home environments
Patient Population: Adult
Receiving and Inspection
Remove this device and other components from the packaging and inspect for damage. If this
device or any other components are damaged, DO NOT USE and contact 1-800-634-4350.
Before using your device, inspect these items and ensure that:
1. The cord with pads is not broken.
2. The gels are not damaged.
3. The device is intact and working.
4. The AC adapter is not broken or damaged.
Symbols Glossary
For symbol information, visit: OmronHealthcare.com/symbols-glossary
Contraindication
Do not use this device if you have a cardiac pacemaker, implanted debrillator or other implanted
metallic or electronic device. Such use could cause electric shock, burns, electrical interference or
death.
3
IMPORTANT SAFETY INFORMATION
Read the Important Safety Information in this instruction manual before using this device.
Follow this instruction manual thoroughly for your safety.
WARNING
•Keep this device out of the reach of infants, toddlers and children because the AC adapter cord
could cause strangulation.
•Consult with your physician b efore using this device, because the device may cause lethal rhythm
disturbances to the heart in susceptible individuals.
•If you have had medical or physical treatment for your pain, consult with your physician before
using this device.
•If you are in the care of a physician, consult with your physician before using this device.
•If your pain does not improve, becomes more than mild, or continues for more than 5 days, stop
using the device and consult with your physician.
•DO NOT apply the pads across your chest because the introduction of electrical current into the
chest may cause rhythm disturbances to your heart, which could be lethal.
•DO NOT apply the pads over open wounds or rashes or over swollen, red, infected or inamed
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. Any area of
pain with swelling or inammation, the condition may worsen.
•DO NOT apply the pads over your neck because this may cause severe muscle spasms resulting in
closure of your airway, diculty in breathing, or adverse eec ts on heart rhythm or blood pressure.
•DO NOT apply the pads on the head, the mouth, or any area of the face.
•DO NOT apply the pads near the heart, or on the genital area.
•DO NOT apply the pads on both sides of the chest cavity simultaneously (lateral or front and back).
•DO NOT apply the pads to both legs, such as calves at the same time because cardiac disturbance
may o ccur.
•DO NOT apply the pads to the b ottom of both feet at the same time because cardiac disturbance
may o ccur.
•DO NOT use this device when bathing, showering, sleeping, during exercise, or while sweating.
•DO NOT use this device on patients with paresthesia (abnormal sensation) or peripheral
neuropathy (damage to your peripheral nerves that causes weakness, numbness, and pain).
•DO NOT apply stimulation while driving, operating machinery or during any activity in which
electrical stimulation can put you at risk of injury.
•DO NOT use this device with any life-supporting electronic medical device such as an articial
heart, lung or respirator.
•DO NOT use this device on pregnant women.
•DO NOT use this device on infants, toddlers, or children because this device has not been
evaluated for pediatric use.
•The unattended use of this pad with gel by infants, toddlers, children or incapacitated persons
may be dangerous.
Indicate s a potentially haz ardous situation w hich, if not avoided, co uld
result in de ath or serious injur y.
4
IMPORTANT SAFETY INFORMATION
•DO NOT use this device on persons incapable of expressing their thoughts or intentions.
•DO NOT use this device on persons who are unable to operate the unit by themselves.
•DO NOT use this device on or near any other heating device or heating element such as a dr yer or
oven.
•DO NOT use this device while using another TENS device.
•DO NOT apply stimulation in the presence of elec tronic monitoring equipment such as cardiac
monitors and ECG alarms, because the equipment may not operate properly when the electrical
stimulation device is in use.
•DO NOT use this device with a heating pad.
•DO NOT use this device under a blanket.
•DO NOT use heat on any muscle or joint which has swelling or edema. It may worsen the pain or
condition.
•DO NOT use over sensitive skin areas or in the presence of poor circulation.
•If used on the elderly, use caution due to more sensitivity of the skin.
•NEVER bend or fold the pads with gels.
•The pad can ONLY be used with the gel.
•If you have any serious illness, consult with your physician before using this device.
•For arthritis pain relief, consult with your physician before using Combo (Modes using heat). The
ecacy of TENS + Heat combination therapy for ar thritis pain relief has not been demonstrated.
•The pad with gel should not come into contact with any liquid or water during therapy.
•Apply pads ONLY to normal, intact, clean, healthy skin of adult patients.
•For Hospitals and Clinics, simultaneous connection of a patient to a high frequency surgical
medical equipment may result in burns at the site of the stimulator electrodes and possible
damage to the stimulator.
•Use the device carefully to avoid serious burns.
•If the device is too hot, stop using it immediately.
•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.
5
IMPORTANT SAFETY INFORMATION
Battery Handling and Usage
•This device contains a built-in rechargeable lithium-ion battery which must be disposed of
properly. Dispose of the device according to applicable local government regulations.
•This rechargeable battery has been specically designed for this product. DO NOT use it in any
other devices.
•DO NOT charge the rechargeable battery once it has been removed from the device.
•DO NOT dispose of the battery into a re.
•DO NOT crush or puncture the battery because it may cause spontaneous ames.
•DO NOT disassemble or modify the device.
•DO NOT connect the + and – poles by using a piece of metal or other conductive objects.
• DO NOT carry it or store it together with item such as necklaces and hair pins.
•DO NOT recharge, use or leave the battery in any high temperature environment such as in a
location near a re or in direct sunlight. Doing so may cause the battery to overheat, ignite or
rupture.
•DO NOT leave a battery that has been removed within reach of children or pets. Doing so may
result in an injury or an accident.
•If liquid comes in contac t with the battery, a re or an accident may occur.
•This product has a built-in rechargeable bat tery. To prevent the risk of overheating, re
or explosion, do not throw into a re, apply heat, puncture or crush, use or leave in a high
temperature environment.
Indicate s a potentially haz ardous situation w hich, if not avoided, m ay
CAUTION
•
•TENS is not eective for pain of central origin, including headache.
•TENS is not a substitute for pain medications or other pain management therapies.
•TENS devices have no curative value.
•TENS is a symptomatic treatment and, as such, suppresses the sensation of pain that would
otherwise serve as a protective mechanism.
•Eectiveness is highly dependent upon patient selection by a practitioner qualied in the
management of pain patients.
•DO NOT use this device to treat one region for extended periods of time. The long-term eects of
electrical stimulation are unknown.
•Since the eects of stimulation of the brain are unknown, stimulation should not be applied across
your head and electrodes should not be placed on opposite sides of your head.
•The safety of electrical stimulation during pregnancy has not been established.
•You may experience skin irritation, redness, burning or hypersensitivity due to electrical
stimulation, the gel or the heat.
•If you experience any skin irritation or redness after a session, DO NOT continue stimulation in that
area of the skin.
result in mi nor or moderate inju ry to the user or pati ent, or cause
damage to th e equipment or othe r property.
6
IMPORTANT SAFETY INFORMATION
•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 you have a tendency to bleed internally, such as following an injury or fracture.
•Consult with your physician prior to using the device af ter a recent surgical procedure because
stimulation may disrupt the healing process.
•Use caution if stimulation is applied over the menstruating uterus.
• Use caution if stimulation is applied over areas of skin that lack normal sensation.
•Use this device only with components provided in the Total Power + Heat packaging and
accessories recommended by the manufacturer. (Refer to subsection 1.1 and section 7)
•Place pads at least 1 inch (3 cm) apar t for optimal results.
•Place pads on either side of the pain, not directly on the pain.
• DO NOT use on wet skin (from sweating, bathing, high humidity).
•DO NOT use this device for any purpose other than what it is intended.
•DO NOT use this device without proper lighting. You may not be able to operate the device
successfully.
•DO NOT use any AC adapter other than the one provided in the packaging of this device.
•The pads are for Single Patient Use Only. NEVER share the pads with another person.
•DO NOT plug the cord into any device other than this device.
•DO NOT move the pads to another location while the device is on.
•DO NOT overlap pads or put them on top of each other because therapy may weaken or stop. Gels
may also stick together and cause the gels to be removed when separating.
•DO NOT leave the pads attached to the skin after treatment.
•DO NOT apply any lotion, cream or ointment to the pads or to your skin because the pads will not
function properly. The self-adhesive gels will not adhere to your skin.
•DO NOT place this device in a room with high humidity, such as a bathroom. This will damage
the device. Ideal temperature for using the device +50 °F to +10 4 °F (+10 °C to +40 °C), 30 to 80 %
relative humidity.
•DO NOT inser t the plug of the cord into any place other than the jack on the device.
•DO NOT pull on the cord during treatment.
•DO NOT bend or pull the end of the cord.
•NEVER at tempt to modify the device.
• Therapy will not work with just one pad. You MUST use two pads at the same time.
•Make sure the components are properly connec ted and the pads are axed to the body part you
wish to treat.
•The pads should not touch any metal object such as a belt buckle or necklace.
•To avoid damage to the adhesive surface of the gel, ONLY put the pads on your skin or the plastic
pad holder.
•ALWAYS place the clean pads in accordance with the illustrations provided
(Refer to sub -section 3.1).
7
IMPORTANT SAFETY INFORMATION
•If the device is not functioning properly or you feel discomfort, immediately stop using the device.
•ALWAYS pull from the plug when removing the cord from the device.
•Replace the cord with pads when broken or damaged.
•Using pads that are too small or incorrectly applied could result in discomfort or skin burns.
•The pads do not work correctly without the gels. For safety and eectiveness, they must be used
together.
•Before use, inspect the cord with pads for open wires or any damage. If damaged, DO NOT use and
replace immediately. The damaged cord with pads may cause skin burns or a re.
•Clean and dr y the aected area so it is free of all lotions, oils and sweat. The pads with gels should
be applied only to normal, intact, clean and healthy skin that is not experiencing any swelling or
inammation.
•While using this device, make sure that no mobile device or any other electrical devices that emit
electromagnetic elds is within 12 inches (30 cm). This may result in poor performance of the
device.
•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 specied as operating conditions after it is stored either
at the maximum or at the minimum storage temperature. For operating, storage and transport
conditions, refer to section 8.
Possible Adverse Reactions
•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.
•You should stop using the device and consult with your physician if you experience adverse
reactions from the device.
•DO NOT use to treat one region for extended periods of time (more than 30 minutes per session,
up to three times/day) or muscles in that region may become exhausted and sore.
Note
• The size, shape and t ype of pads may aect the safet y and eectiveness of electrical stimulation.
• The electrical performance characteristics of pads may aect the safet y and eectiveness of
electrical stimulation.
8
HOW THE DEVICE WORKS
How does the device work?
The OMRON Total Power + Heat is an innovative device that relieves chronic, acute* and arthritic
pain through the pain relief of TENS and soothing comfort of heat. Physical therapists have been
using the combination of heat and TENS for decades.
Scientic theory suggests that TENS therapy may work in several ways:
1. 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.
Gentle electrical pulses increase the production of the body’s natural pain killers, such as
endorphins.
3.
Blood circulation improves as muscles contract and relax with the ow of the electrical stimulation.
* Acute pain ref ers to sore or achy mus cles due to strain f rom exercise or nor mal household an d work activiti es.
9
1. KNOW YOUR DEVICE
Power plug
1.1 Contents
o Device o Cord with Pads o Pad Holder o Gels (2 pairs)
o AC Adapter (HHP-AM11)
AC adapter plug
o Soft Case o Instruction Manual
1.2 Part Names and Functions on the Device
< Device >
[Power] Button
Press to turn the
device on. Press again
to turn o.
[Intensity] Button
Set the intensity level
according to your needs.
Press [▲] or [►] for higher
intensity.
Press [▼] or [◄] for lower
intensity.
Cord Jack
10
Screen
[SET/START] button
Press to set a mode or
start therapy.
o Quick Start Guide/
Pad Placement
Guide
AC Adapter
Jack
< Screen >
Cord plug
1. KNOW YOUR DEVICE
“Battery” symbol
If the battery is low,
the “Battery” symbol
will appear.
“Pad” symbol
If the pad detaches,
will appear.
< Cord with Pads >
Mode
Intensity Level
Pads
Gel
Dark
side
Minutes Left of Therapy
HEAT
Cord
11
2. PREPARATION
Charging
2.1 Charging
• If you are using the device for the rst time or the device has not been used for more than three
months, charge the battery to full.
• Once fully charged, the battery will last for approximately four 30-minute uses on average. Once
the battery has been depleted, it takes about ve hours to charge.
• Recommended temperature during bat tery charging: 41 °F to 95 °F (+5 °C to +35 °C)
1 Connect the AC adapter plug to the AC adapter jack on the device.
Rechargeable battery inside
f device (DO NOT REMOVE)
2 Plug the AC adapter into an electrical outlet.
Electrical outlet
CAUTION
• DO NOT use any AC adapter other than the one provided in the packaging of this device
Note:
• Make sure not to place your device in a location where it is dicult to plug and unplug the AC
adapter.
• When charging the battery, the “Batter y” symbol ashes on the screen.
o
.
• When fully charged, the symbol ( ) will ash shortly on the screen, then power will b e
turned o. Press the [Power] button to check that the batter y is fully charged.
• For the battery status, refer to “Battery” (Page 13).
12
2. PREPARATION
3 Once the battery is fully charged, unplug the power plug, then unplug the AC adapter plug.
1
2
• Unplug the AC adapter when using the device.
“Battery” symbol
Note: While the battery is charging, the device does not work.
Display Description
Batter y charge is full.
Batter y charge is about half full.
Batter y is close to low.
Battery is depleted.
Battery Life
Your device will last up to four 30-minute uses per charge, depending on the use and the storage
condition.
Battery lifespan
Battery life depends on usage and storage conditions. When fully charged, the rechargeable battery
will last for up to 500 uses when used one time per day in normal temperatures. See section 8 for
recommended temperature during battery charging.
13
2. PREPARATION
2.2 Assembling Steps
1
Prepare pads.
Attach the cord plug into the bottom left side of the device. Place the pads (dark side up) onto a
at surface.
Note: Do not turn the power on before placing the pads on the body.
CAUTION
• Before use, inspect the cord with pads for open wires or any damage. If damaged, DO NOT use and
replace immediately. The damaged cord with pads may cause skin burns or a re.
2 Assemble gels.
For rst time use, remove the gels from the sealed plastic bag.
The pads an d the gels must be used to gether for safet y and eectivene ss.
Note:
Clean and dr y aected area so i t’s free of all lotions/oils/sweat.
3 Place gels onto the pads.
Each gel has two plastic lms. Remove the non-printed side of plastic lms and place gels squarely
onto the dark side of the pads.
Make sure the gel lays evenly and securely with no bubbles, bending or missing pieces. Check for
damage and check the adhesion before each therapy session.
The “SKIN” printed side of plastic lms are on top.
14
2. PREPARATION
STORING THE PADS ON THE PAD HOLDER
Remove the plastic lm and place the adhesive side of the gel on
either side of the pad holder.
Pad facin g down
Pad holder
Adhesive s ide up
15
3. GET STARTED WITH YOUR THERAPY
3.1 Placing Pads
Before therapy:
• Make sure that the pads stick to the skin.
• 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.
CAUTION
For optimal therapy:
•Clean and dr y aected area so it is free of all lotions, oils and sweat. The pads with gels should
be applied only to normal, intact, clean and healthy skin that is not experiencing any swelling or
inammation.
•Place pads on either side of the pain, not directly on the pain.
•Place pads at least 1 inch (3 cm) apar t for optional results.
•Therapy will not work with just one pad. You MUST use two pads at the same time.
•DO NOT overlap pads or put them on top of each other because therapy may weaken or stop. Gels
may also stick together and cause the gels to be removed when separating.
•DO NOT apply any lotion, cream or ointment to the pads or to your skin because the pads will not
function properly. The self-adhesive gels will not adhere to your skin.
•The pads are for Single Patient Use Only. NEVER share the pads with another person.
1 Remove the “SKIN” printed side of plastic lms and place the pads onto the skin.
Note: DO NOT turn the device on until pads are on your skin. You MUST use both pads,
otherwise stimulation will not work.
16
3. GET STARTED WITH YOUR THERAPY
WARNING
DO NOT APPLY THE PADS TO THES E BODY AREAS:
On the head, the mouth, or any area of the face.
Over your neck because this may cause severe muscle spasms resulting in closure
of the airway, diculty in breathing, or adverse eects on heart rhy thm or blood
pressure.
Near the h eart, or on the genital area.
On both sides of the chest cavity simultaneously (lateral or front and back), or across
your chest because the introduction of electrical current into the chest may cause
rhythm disturbances to your heart, which could be lethal.
On both legs, such as calves at the same time because cardiac disturbance may occur.
On the bottom of both feet at the same time because cardiac disturbance may occur.
Open wounds or rashes or over swollen, red, infected or inamed areas or skin eruptions
(such as varicose veins, phlebitis, thrombophlebitis and thrombosis), or on top of or close to
cancerous lesions, or over ares of skin that lack normal sensation. Any area of pain with swelling or
inammation, the condition may worsen.
17
3. GET STARTED WITH YOUR THERAPY
(USE FOR A MAXIMUM OF ONE 30 MINUTES PER SESSION)
Attach both pads on the lower back according to your pain.
Place pads on muscle of the lower back, not on spine.
Attach one pad below and above the region in pain, both on
same side.
LOWER BACK
LOWER BACK
18
3. GET STARTED WITH YOUR THERAPY
Attach pads on each side
ARM
of the region where you
feel pain.
HIP & THIGH
Attach pads on each side
of the area with pain.
LEG
JOINT
ELBOW
Attach pads on each side
of the joint with pain.
JOINT
KNEE
Attach both pads above the knee or
above and below the joint with pain.
19
3. GET STARTED WITH YOUR THERAPY
LEG
Attach both pads on the calf where you feel pain.
WARNING
• DO NOT appl y the pads to both legs, su ch as calves at the same time
because cardiac disturbance may occur.
Attach pads on the lef t 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 appl y the pads to the bottom o f both feet at the same ti me
because cardiac disturbance may occur.
CALF
Outside
Inside
FOOT
ANKLE
20
3. GET STARTED WITH YOUR THERAPY
Attach both pads on the shoulders according to your pain.
Attach each pad on the front and back of your shoulder.
SHOULDER
SHOULDER
WARNING
•DO NOT apply the pads on both sides of the chest cavity simultaneously (lateral or front and back).
•DO NOT appl y the pads across your che st because the intro duction of elec trical current into the ch est
may cause rhy thm disturbances to you r heart, which could b e lethal.
• D O NOT apply the pads nea r the heart.
21
3. GET STARTED WITH YOUR THERAPY
3.2 Selecting a Mode
1
Press the [Power] button to turn on.
2 Press [ ] [ ] or [ ] [ ] buttons to select a mode.
3 Press [SET/START] button to set the mode.
How to swit ch modes
When the device is turned on again, the last mode selected is set automatically.
Press [SET/START] button and [
again to set a mode.
How to select a mode properl y
Any of the modes can be used on body parts or pains described in this manual or Quick Star t Guide/
Pad Placement Guide.
Select the mode to treat your unique pain.
] [ ] or [ ] [ ] buttons to change modes. Press [SET/START] button
Therapies
designed for
What does the
therapy deliver?
Shoulder Lower Back Arm Leg
Series of low
to high rate
tapping, pulsing,
kneading and
massage-like
sensations.
Series of high to low
rate tingling sensations,
followed by tapping.
With higher intensity,
you may feel kneading
or massage -like
sensations.
Series of low to
medium rate
tapping, tingling
and pulsing
sensations.
Series of low
to medium
rate tapping
and rubbing
sensations.
22
3. GET STARTED WITH YOUR THERAPY
Therapies
designed for
What does
the therapy
deliver?
Joint Foot Tap Knead Rub
Series of
medium to
high rate
tapping,
pulsing
sensations.
Series of low
rate tapping,
pulsing
sensations.
Series of low
rate tapping
sensations.
Series of
medium
rate pulsing
sensations
to mimic
massage.
23
Series of high
rate pulsing
sensations to
mimic hands
rubbing.
3. GET STARTED WITH YOUR THERAPY
3.3 Setting the Therapy
Combo Therapy*
HEAT
HEAT
HEAT
HEAT
HEAT
HEAT
HEAT
HEAT
START
Combo Therapy delivers heat and TENS alternately for a total of 30 minutes of therapy.
TENS Therapy*
15 min 30 min
START
TENS Therapy provides only TENS for 30 minutes.
15 min 30 min
* Approximate pattern, not exact
24
3. GET STARTED WITH YOUR THERAPY
Combo therapy
1 Press [SET/START] button after “HEAT” is visible.
2 Therapy delivers heat and TENS alternately. “HEAT”
lights orange during “HEAT” and the orange light
goes o during “TENS”.
TENS therapy
1
Press [ ] or [ ] or [ ] or [ ] button after “HEAT” is
visible.
2 Press the [SET/START] button after “HEAT” is no
longer visible to select the “TENS” therapy.
Note:
• All therapies automatically stop after 30 minutes.
• To change therapies, turn the device o, then on again.
25
3. GET STARTED WITH YOUR THERAPY
Minutes left out
3.4 Adjusting Intensity Level
The Intensity Level is set at “3” when the therapy starts.
Actual intensity level will star t at “1” and slowly increase to “3”.
When the device is in “TENS” stimulation, press [
intensity. Adjust the intensity level from “1” to “20” until you feel a gentle pulsing sensation.
How do I select the intensit y level properly for my pain?
If the stimulation sensation becomes weaker or disappears, increase the intensit y until it is restored. If
the sensation is at all uncomfortable, press
•
Press
[ ]
or
[ ]
•
Press
How long do es the therapy last?
The device automatically stops after 30 minutes. We recommend a maximum of one 30-minute
therapy in one sitting, up to three times/day.
The screen shows you how many minutes are remaining.
button for higher intensity.
[ ]
or
[ ]
button for lower intensity.
] [ ] or [ ] [ ] button to increase or decrease
[ ]
or
[ ]
button to decrease the intensity.
Intensity level
out of 20 levels
of 30 minutes
26
4. HOW TO CONTROL AND REDUCE YOUR PAIN
When should I start therapy?
Use this device as soon as your pain begins. Start with one session, the device automatically turns o
at 30 minutes.
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.
Recommended duration of use
Start with one 30-minute session. Rate your pain. A rating of 1 indicates less pain whereas a rating of 10
indicates a high amount of pain. Stop therapy session if pain has reduced or stopped.
1 session Max minutes/session Max times/day
30-minute 30 minutes 3 times pe r day
automatic shut-o
CAUTION
Possible Adverse Reactions
•DO NOT use to treat one region for extended periods of time (more than 30 minutes per a session,
up to three times/day) or muscles in that region may become exhausted and sore.
When to stop using the device?
Stop using this device:
• If you experience an adverse reaction (skin irritation/redness/burns, headache or other painful
sensation) or if you feel any unusual discomfort.
• If your pain does not improve, becomes seriously chronic and severe, or continues for more than
ve days.
Remember that the device does not cure your pain or the original cause of the pain. It provides
temporar y relief or reduction of pain so that you can control your life and activities better.
27
5. MAINTENANCE
5.1 Storage
1
Turn the device o and remove the cord plug from
the bottom of the device.
2 Remove the pads from your body.
3 Place the adhesive side of each pad on the pad
holder.
4 Wrap the cord around the pad holder.
• Do not keep in areas subject to direct sunlight, high or
low temperatures, humid areas, near a re, vibration
or shock.
Storage temperature
+32 °F to +104 °F (0 °C to +40 °C) 30 to 80 % relative humidit y.
• Do not wrap the cord around the device because it
may damage the cord.
WARNING
•NEVER bend or fold the pads with gels.
•Keep this device out of the reach of infants, toddlers and children.
28
5. MAINTENANCE
5.2 Cleaning
The cord with pads and the device can be cleaned, but you cannot clean the gels.
Cleaning the cord with pads
1 Remove the gels and discard before cleaning the pads.
• The gels cannot be cleaned.
2 Wipe the surface with a soft cloth moistened with
water or a neutral detergent.
• Do not get the cord wet.
• Do not wash the pads with running water.
3
Let air dry before placing new gels onto the pads, do not use old gels.
Gels are r eplaceable and c an be purchased when needed by calling 1-800 -634-4350 or going
to OmronHealthcare.com.
Cleaning the device
1
Turn the device o and disconnect the cord with pads from the device.
2 Wipe the surface of the device with a soft cloth that has been moistened with water or neutral
detergent, then dry completely using a soft cloth.
• Do not use chemicals such as thinner and benzene to clean the device.
• Do not let water get into the internal area of the device.
When to replace the gels?
Replace the gels when they no longer stick rmly to your skin, or if more than 25 % of the gel is not
in contact with your skin, replace the gel.
5.3 Disposal
Dispose of the device and battery in accordance with local government regulations.
29
6. 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.
Problem Possible cause Solution
The intensity is not felt.
The intensity level is too weak.
The skin turns red or feels
irritated.
The device cannot be turned
on.
The device cannot be charged. The AC adapter is not
Only one pad is attached. Place two pads on your skin.
The plastic lms have not been
removed from gels.
The pads are stacked together
or pads overlap.
The cord is not connected
properly to the device.
The intensity is set too low.
The adhesive surface is
damaged.
The battery is depleted.
The adhesive surface of gel
is dirty.
The therapy duration is too
long.
The two pads are not adhered
to the body properly.
The adhesive surface of gel is
damaged.
The battery is depleted.
connected properly.
Peel o the lm from the
adhesive surface of gels.
Check placement of pads. Refer
to “Pad Placement Guide”.
Connect the cord plug correctly
into the cord jack at the bottom
of the device.
] or [ ]button.
Press [
Replace the gel.
Charge the battery fully.
Replace the gel.
Shorten therapy to less than 30
minutes.
Refer to the “Pad Placement
Guide” and adhere correctly.
Replace both gels at the same
time.
Charge the battery f ully.
Check to ensur e the AC adapter is
properly connected to the device.
Check if AC adap ter is connected
to an electrical outlet.
30
6. TROUBLESHOOTING
Problem Possible cause Solution
Power cut o during use. The battery is depleted. Charge the bat tery fully.
The cord is broken. Replace the cord with pads.
“Batter y” symbol is displayed.
.
The adhesive surface of the gel
does not stick to skin.
The device or the AC adapter is
abnormally hot when charging
the bat tery.
is displayed.
Only one pad is attached.
The battery is depleted. Charge the bat tery fully.
The plastic lm has not been
removed.
The pad or your skin is wet. Air dry the adhesive sur face of
The adhesive surface is
damaged.
There is too much hair on your
skin.
The gels were stored under
the high temperature, high
humidity or direct sunshine.
The device or the AC adapter
may be damaged.
Only one pad is attached, or
both pads are not attached.
The plastic lm has not been
removed.
The cord is not connected to
the device properly.
The adhesive surface of gels
are dirt y or dry.
Place two pads on your skin at
the same time.
Peel o the lm from the
adhesive surface of the gel.
the gel or skin.
Replace the gel.
Shave the immediate area for
proper gel adhesion.
The gels are u nable to be
used because of the storage
condition. Replace both gels.
Unplug the AC adapter from
the electrical outlet and the
cord plug from the device
immediately.
Reattach detached pad(s) onto
the skin rmly.
Peel o the lm on the
adhesive surface of the gel.
Connect the cord plug
correctly into the cord jack at
the bottom of the device.
Replace the gels.
31
6. TROUBLESHOOTING
Problem Possible cause Solution
The pads are not getting hot. The cord is not connected to
The pads are too hot on the
skin and there is a burning
scent.
E1 is displayed.
E2 is displayed.
E3 is displayed.
E4 is displayed.
The operating time is short or
the device does not operate,
even when the battery is fully
charged.
If you are not able to solve your problem, contact 1-800- 634-4350.
the device properly.
The cord is disconnected or
shortcircuited.
The cord is shortcircuited. Stop using the device
The pad with gel is damaged. Stop using the device
The cord is not connected to
the device properly.
The cord is internally
shortcircuited.
There are errors in the device.
The device is being used
outside of the operating
temperature.
This may be due to the life of the rechargeable battery. However,
the battery cannot be replaced.
Please dispose of the device.
Check if the cord is properly
connected.
Replace the cord with pads.
immediately, and replace the
cord with pads.
immediately, and replace the
entire cord with pads and/
or gels.
Check if the cord is properly
connected. If the error is still
displayed, the cord may be
broken (damaged). Replace the
cord with pads.
Stop using the device
immediately and replace the
cord with pads.
The device may be damaged.
Stop using the device
immediately, and contact 1-800634- 4350.
Leave the device within the
operating temperature (+50 °F
to +104 °F (+10 °C to +40 °C))
for a while before use.
32
7. OPTIONAL ACCESSORIES
Gels (3 pairs)
REF
PMGEL
To order, visit: OmronHealthcare.com
HV-PA D-3Z
33
8. SPECIFICATIONS
Product Name OMRON Total Power + Heat
Model #
Power Source
Battery Lifespan Will last for 500 uses when fully charged and under the
Frequency Approx. 0.7 to 108 Hz
PULSE Duration 100 μ sec
Maximum Output Voltage 70 V (during 500 Ω load)
Power Control 20 intensity levels
Operating conditions +50 °F to +104 °F (+10 °C to +40 °C),
Storage conditions
Battery charging condition +41 °F to +95 °F (+5 °C to +35 °C)
Transportation conditions
Weight Approx. 6.7 oz (190 g)
Outer Dimension Approx. 4.1" (W) × 4.1" (H) × 1.1" (D) (103 mm × 103 mm × 29 mm)
Classication of ME equipment
IP classication Device: IP 22 / AC adapter: IP21
Operation Mode Continuous operation
Applied Part
Maximum temperature of the
applied part
Durable period (Service Life) Device: 5 years
Note:
• These specications are subject to change without notice.
• IP classication is degrees of protection provided by enclosures in accordance with IEC 60529.
This device and AC adapter are protected against solid foreign objects of diameter of 12.5 mm
diameter and greater, such as a nger. The AC adapter is protected against ver tically falling water
drops which may cause issues during a normal operation and protected against oblique falling
water drops which may cause issues during a normal operation.
REF
PM800
1 Lithium-ion battery
(DC 3.7 V; Approx. 1510 mAh)
AC adapter
(INPUT AC100-240 V, 50-60 Hz, 0.12-0.065 A)
following conditions: new battery was fully charged, used one
time/day in normal temperatures of 73.4 °F (+23 °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 (non- condensing)
-4 °F to +140 °F (-20 °C to +60 °C), 10 to 95 % RH
Internally powered ME equipment (operating) / Class II
(charging)
Type BF (Pads)
Lower than +109.4 °F (+43 °C)
Gels: 30 uses
AC adapter: 5 years
HV-F320-Z W
34
9. FCC STATEMENT
FCC CAUTION
Changes or modications not expressly approved by the party responsible for compliance could
void the user ’s authority to operate the equipment.
This device complies with Part 15 of FCC Rules. Operation is subject to the following two conditions:
(1) this device may not cause harmful inter ference, and (2) this device must accept any inter ference
received, including interference that may cause undesired operation.
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 inter ference 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
o and on, the user is encouraged to try to correct the interference by one or more of the following
measures:
• Reorientorrelocatethereceivingantenna.
• Increasetheseparationbetweentheequipmentandreceiver.
• Connecttheequipmentintoanoutletonacircuitdierentfromthattowhichthereceiveris
connected.
• Consultthedealeroranexperiencedradio/T Vtechnicianforhelp.
35
10. LIMITED WARRANTY
Your OMRON Total Power + Heat is warranted to be free from defe cts in materials and workmanship
appearing within 1 year from the date of purchase, w hen used in accordance with the instructions
provided with the device. The above warrant y extends only to the original retail purchaser.
The cord with pads is warr anted to be free from defects in materials and workmanship appearing
within 30 days f rom the date of purchase w hen the device is used in accordance with the
instruc tions provided with the device. T he above warranty e xtends only to the original retail
purchaser.
We will, at our op tion, replace without charge any device covered by the above war ranty.
Replacem ent is our only responsibility and your only remedy under the above w arranty.
To obtain warranty ser vice, contact Custom er Service by calling 1-800 -634-4350 for th e address of the
inspection center and the return shipping and handling f ee that may apply.
Enclose the original proof of purchase. Include a letter, with your name, address, ph one number,
and description of the specic problem. Pa ck the product care fully to prevent damage in transit.
Because of possible loss in transi t, 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.
SOME STATES DO NOT ALLOW LIM ITATIONS O N HOW LONG AN IMPLIED WARRAN TY LASTS, SO TH E
ABOVE LIMI TATION 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 DO NOT ALLOW TH E EXCLUSION OR LIMITATION OF INCIDENTAL OR CONSEQUENTIAL
DAMAGES, SO THE ABOVE LIMITATION OR EXCLUSION MAY NOT APPLY TO YOU.
This warranty provides you with specic legal right s, and you may have other rights that var y by
jurisdiction.
Visit our web site at: OmronHealthcare.com
Call toll free: 1-800-634- 4350
FOR CUSTOMER SERVICE
36
11. GUIDANCE AND MANUFACTURER’S DECLARATION
OMRON Total Power + Heat Information for Accompanying Documents in the Scope of
IEC60601-1-2:2014
Important information regarding Electromagnetic Compatibility (EMC)
PM800 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 PM800 on the website.
37
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.
OmronHealthcare.com
© 2019 OMRON HEALTHCARE, INC.
Made in China
Omron Healthcare helps you
make positive lifestyle changes
with innovative home health
products that you can use
safely and accurately at home.
OmronHealthcare.com
For questions: 1-800-634-4350
Get general pain info:
OmronHealthcare.com
46030 64-2A
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