Omron Focus PM710-M User manual

Focus
TENS Therapy for Knee
PM710-M
PM710-L
Instruction Manual

1
Table of Contents
Introduction 2
Safety Instructions ................................................................................................................2
Intended Use...........................................................................................................................2
Receiving and Inspection...................................................................................................2
Symbols Glossary...................................................................................................................2
Contraindication....................................................................................................................3
Important Safety Information ..........................................................................................3
How the Device Works ........................................................................................................8
1. Know Your Device 9
1.1 Contents .............................................................................................................................9
1.2 Part Names and Functions on the Device .............................................................10
2. Preparation 13
2.1 Charging.............................................................................................................................13
2.2 Attaching the Device ....................................................................................................15
3. Using the Device 16
3.1 Attaching the Band Below Your Knee.....................................................................16
3.2 Get Started with Your Therapy..................................................................................20
4. Maintenance 23
4.1 Cleaning .............................................................................................................................23
4.2 Storage ...............................................................................................................................26
4.3 Disposal..............................................................................................................................26
5. Troubleshooting 27
6. Optional Accessories 30
6.1 Optional Accessories .....................................................................................................30
6.2 Optional Accessories - How to Measure for Band Size .....................................31
7. Specications 32
8. FCC Statement 34
9. Limited Warranty 35
10. Guidance and Manufacturer’s Declaration 36

2
Introduction
Thank you for purchasing the OMRON Focus TENS Therapy for Knee. Focus is a
wearable, wireless TENS (Transcutaneous Electrical Nerve Stimulation) device
that is designed to alleviate chronic, acute and arthritic pain. It delivers TENS
technology through simple, convenient control.
TENS is a safe and drug-free treatment for pain that has been used for over 40
years by medical professionals such as physical therapists and chiropractors.
Safety Instructions
This instruction manual provides you with important information about Focus.
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 device is intended for the relief of pain associated with sore or aching
muscles of the lower extremities (leg) due to strain from exercise or normal
household work activities. It is also intended for the use of symptomatic relief and
management of chronic, intractable pain associated with arthritis.
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.
Symbols Glossary
For symbol information, visit: OmronHealthcare.com/symbols-glossary

3
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.
Important Safety Information
Read the Important Safety Information in this instruction manual before
using this device.
Follow this instruction manual thoroughly for your safety.
Indicates a potentially hazardous situation which, if not
avoided, could result in death or serious injury.
WARNING
• Consult with your physician before using this device if you have:
-
Acute inflammation around your knee, such as swelling, fever or reddish tint
(include the inflammatory condition of osteoarthritis of knee/ rheumatoid arthritis)
- Inflammation or open wound of the knee joints, fracture or meniscus injury
- Paralysis of lower limb
- Surgical history of the knee which includes artificial knee joint replacement
• DO NOT use this device during exercise if you are restricted from exercising by
your physician.
• DO NOT use this device during vigorous exercise such as playing sports or
climbing.
• DO NOT use this device in areas other than below the knee.
• DO NOT use this device on both knees simultaneously.
• DO NOT use this device if the circumference below your knee is out of the
specified range of the band size.
• DO NOT use this device on persons who walk with a cane or cannot walk
normally by themselves.
• Keep this device and pad out of the reach of infants, toddlers or children.
• Keep out of the reach of infants, toddlers or children because the AC adapter
cord could cause strangulation.
• Consult with your physician before 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.

4
Important Safety Information
• If your pain does not improve, becomes more than mild, or continues for more
than five days, stop using the device and consult with your physician.
• DO NOT place this device across your chest or near your heart because the
introduction of electrical current into the chest may cause rhythm disturbances
to your heart, which could be lethal.
• DO NOT place the pad near or on cancerous lesions, diseased skin, open
wounds, rashes, swollen, red, infected or inflamed areas or skin eruptions such
as phlebitis, thrombophlebitis and varicose veins.
• DO NOT place the pad over your neck because this could cause severe muscle
spasms resulting in closure of your airway, difficulty in breathing, or adverse
effects on heart rhythm or blood pressure.
• DO NOT place the pad on or near the head, mouth, face, heart or genitals.
• DO NOT use this device when bathing, showering, sleeping, during exercise, in
high humidity or rainy weather or if sweating.
• 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 on infants, toddlers, children, pregnant women, persons
incapable of expressing their thoughts or on persons unable to operate the
device by themselves.
• DO NOT use this device while using another TENS device.
• DO NOT apply stimulation in the presence of electric monitoring equipment
such as cardiac monitors and ECG alarms because the equipment may not
operate properly when the device is in use.
• NEVER bend or fold the pad.
• If you have any serious illness, consult with your physician before using this
device.
• Apply the pad ONLY to normal, intact, clean, healthy skin of adult patients.
• 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.
• For Hospitals and Clinics: Simultaneous connection of a patient to high
frequency surgical equipment and this device may result in burns at the site of
the stimulator electrodes and possible damage to the stimulator.

5
Important Safety Information
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.
CAUTION
• TENS is not effective for pain of central origin, including headache.
• TENS is not a substitute for pain medications and 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.
• Effectiveness is highly dependent upon patient selection by a practitioner
qualified in the management of pain patients.
• DO NOT use this device to treat 1 region for extended periods of time. The long-
term effects of electrical stimulation are unknown.
• If you experience any skin irritation or redness after a session, DO NOT continue
stimulation in that area of the skin.
• 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.
• DO NOT place the charger within 6 inches (approx. 15 cm) of any person who is
using a pacemaker or implantable cardioverter defibrillator (ICD). The charger
emits electromagnetic fields, which may affect pacemakers or ICDs.
Battery Handling and Usage
• To prevent the risk of overheating, fire or explosion:
- DO NOT puncture, crush, disassemble or modify the device.
- DO NOT throw the device into a fire.
- DO NOT recharge, use, or leave the device in high temperature locations near a
fire or in direct sunlight.
• The 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.

6
Important Safety Information
• 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 after 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 Focus packaging and
accessories recommended by the manufacturer. (Refer to sub-section 1.1 and
section 6)
• DO NOT apply the pad with wet hands, and DO NOT apply the pad if it is wet.
• The pad is for Single Patient Use Only. NEVER share the pad with another
person.
• DO NOT leave the pad placed on the skin after treatment.
• DO NOT overlap the adhesive surfaces of the pad or put them on top of each
other.
• DO NOT apply any lotion, cream or ointment to the pad.
• NEVER attempt to modify the device.
• The pad should not touch any metal object.
• To avoid damage to the adhesive surface of the pad, ONLY put the pad on the
skin or the plastic pad holder.
• ALWAYS place the clean pad in accordance with the illustrations provided (Refer
to sub-section 3.1).
• If the device is not functioning properly or you feel discomfort, immediately
stop using the device.
• Clean and dry affected area so it is free of all lotions, oils and sweat.
• Clean or change the pad when it loses adhesion.
• DO NOT put any metal objects such as a coin or clip on the charger.
• DO NOT use the device when the band is damaged or the hook and loop
fasteners lose cohesion.
• When using the device, make sure that the hook and loop fastener does not
touch your clothing.
• While using this device, make sure that no mobile device or any other electrical
devices that emit electromagnetic fields is within 12 inches (30 cm). This may
result in poor performance of the device.

7
Important Safety Information
• DO NOT fasten the band too tight.
• DO NOT use this device if the adhesive surface of the pad is damaged.
• Ensure that this device has acclimated to room temperature before using.
Using this device after an extreme temperature change could lead to 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 section 7.
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.

8
The OMRON Focus is a wearable, wireless TENS device that provides relief of
chronic, acute* and arthritic pain. 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 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.
Recommended Session Time
30 minutes per session is recommended.
2 sessions per day at maximum is recommended.
* Acute pain refers to sore or achy muscles due to strain from exercise or normal household
and work activities
How the Device Works

9
1.1 Contents
1. Know Your Device
Device Knee Band M/ Knee Band L
PM710-M: Knee Band M
PM710-L: Knee Band L
Soft Case Knee Pad
AC Adapter
HHP-AM01
Pad Holder
Refer to sub-section 4.2 for instructions on
how to use.
Charger
HV-WCHAA-Z
Instruction Manual
Quick Start Guide

10
B
C
DE
F
A
Front
Back
ABattery indicator Lights or flashes according to the battery status.
Refer to sub-section 1.2.2.
BIntensity level
indicators
Lights or flashes according to the intensity level or
situation. Refer to sub-section 1.2.1.
C[Intensity] button
Set the intensity level according to your needs.
Press [+] to increase intensity level.
Press [-] to decrease intensity level.
D[Power] button Press once to turn the device on. Press again to
turn the device off.
EConnection port Used for attaching the pad as well as securing the
device to the battery charger.
F[Pad release]
button Press to remove the pad from the device.
1.2 Part Names and Functions on the Device

11
1.2 Part Names and Functions on the Device
1.2.1 Intensity Level Indicators
Indication Description
All indicators: off
The power is off.
All indicators: flash
On standby.
Press [+] button to start your therapy.
1st, 3rd, 5th indicators:
flash
An error has occurred. Contact customer service.
Refer to section 9.
Refer to sub-section 3.2 for the description of intensity level indicators during
treatment.

12
1.2.2 Battery Indicator
Indication Description
Flashes orange
Battery is close to low. Charge the battery.
Lights orange, then the
device turns off
Battery is depleted. Charge the battery
immediately.
Flashes orange every 2
seconds
The battery is being charged. When it is fully
charged, the indicator will go off.
1.2 Part Names and Functions on the Device

13
Before using the device, inspect to ensure that:
1. The pad is not damaged.
2. The device is intact.
3. The AC adapter is not broken or damaged.
• If you are using the device for the first time or the device has not been used for
more than 3 months, charge the battery to full.
• Once fully charged, the battery will last for approximately 10 uses (1 use: 30
minutes). Once the battery has been depleted, it takes about 8 hours to charge.
• Temperature while battery is charging should be +41 to +95 °F (+5 to +35 °C).
If the device and pad are connected:
Remove the device from the pad before
charging the battery.
While pressing the pad release button, lift the
device.
Pad releas
e
button
1Insert the AC adapter plug into the
AC adapter jack on the charger.
Charger
2. Preparation
2.1 Charging

14
2Plug the AC adapter into an electrical outlet.
Electrical outlet
Note
• Only use the AC adapter and charger provided with this device for charging.
• Make sure not to place this device in a location where it is difficult to plug
and unplug the AC adapter.
3Set the device on the charger to
initiate charging.
While charging the battery, the battery
indicator on the right flashes orange.
When the battery is fully charged, the battery
indicator will go off.
Battery
indicator
4Once the battery is fully charged, unplug the AC adapter and
remove the device from the charger.
Battery Life
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 7 for recommended temperature during battery
charging.
2.1 Charging

15
2.2 Attaching the Device
For first time use, remove the pad from the plastic
bag and attach it to the device. Do not remove the
plastic film on the back of the pad yet.
Note:
• To avoid damage, take care not to bend or damage
metal connectors. Metal connector
1Put the connector of
the pad through the
band port.
Connector
Pad
Band port
2Hook one side of the
device onto the band.
3Attach the connector
to the connection port
and push the device
until it clicks.
4The pad and band are
now attached to the
device.
Make sure the connection
port is attached firmly to
the connector.

16
3. Using the Device
3.1 Attaching the Band Below Your Knee
1Remove the protective
sheet from the loop
fastener.
2Remove the plastic films
from the pad.
For first time use, remove and
discard the plastic film from the
back of the pad.
3Sit on a chair and bend your knee 90°.

17
4Align the device as shown in the following illustration.
Place the band on your bare skin directly.
Face the side with the indicator lights upward.
Make sure the device is on the inside of your knee.
If you attach the device on the left knee, align the mark “L” indicated on the
band with the center of your knee.
If you attach the device on the right knee, align the mark “R” indicated on
the band with the center of your knee.
Make sure the band is below the back of your knee for maximum comfort.
Left Knee Placement Right Knee Placement
located on the
center of your knee
located on the
center of your knee
Make sure the
band is below the
back of your knee
for maximum
comfort.
3.1 Attaching the Band Below Your Knee

18
5Wrap the band below your knee, then attach the hook and loop
fastener so that the band does not slip.
Left Knee Placement Right Knee Placement
Make sure the band is placed below your knee as shown in the
following illustration. The device should be on the inside of your knee.
This device stimulates the area preventing the knee pain, NOT the area you
have pain. The stimulation prevents transmission of the pain and relieves it.
Left Knee Placement Right Knee Placement
3.1 Attaching the Band Below Your Knee

19
• DO NOT use this device during vigorous exercise such as playing sports or
climbing.
• DO NOT use this device in areas other than below the knee.
• Apply the pad ONLY to normal, intact, clean, healthy skin of adult patients.
• NEVER bend or fold the pad.
NEVER APPLY THE PADS TO THESE BODY AREAS:
• On or near the head, mouth or face.
• On your neck because this could cause severe muscle spasms resulting in
closure of the airway, difficulty in breathing, or adverse effects on heart rhythm
or blood pressure.
• Near the heart or genitals area.
• On 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.
For optimal therapy,
• DO NOT overlap the adhesive surfaces of the pad or put them on top of each
other.
• DO NOT apply any lotion, cream or ointment to the pad.
• Clean and dry affected area so it is free of all lotions, oils and sweat.
• The pad is for Single Patient Use Only. NEVER share the pad with another person.
Note:
• Check to make sure that the pad is not peeling off during treatment sessions.
• DO NOT use the pad after expiration date.
• DO NOT touch the adhesive surface of the pad with your fingers.
• If the pad accidentally sticks to clothing, slightly moisten the pad from the
opposite side of the clothing and then, peel it off. DO NOT forcibly peel the pad
off of the clothing.
• Clean or change the pad when it loses adhesion.
3.1 Attaching the Band Below Your Knee
WARNING
CAUTION