Omron E4 Tens User manual

Instruction manual page 01
Gebrauchsanweisung Seite 17
Gebruiksaanwijzing pagina 33
Mode dʼemploi page 49
Manuale de instructone pagina 65
Manual de instrucciones pagina 81
E4 Tens
E4 Tens Massager
Low-Frequency Electronic Pulse Massager
IM-HV-F128-E-04-10/2011
1628187-0G
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1
E4 English
INTENDED USE
Medical Purpose
This Electronic Nerve Stimulator is intended to
be used as a massager to relieve (muscle) pain,
stiffness and fatigue. The massaging effect is
achieved by electronic stimulation of the nerves
through electrode pads placed on the skin.
Various massage regions and treatment
programs can be selected.
Suitable Users
Please read “Notes on safety” before using the
unit. (This unit should not be used by people
prohibited from doing so in “Notes on safety”.)
Environment
This unit is intended for home use only.
Effectiveness
Massager: relieve of (muscle) pain, stiffness and
fatigue
Precautions for use
Please read “Notes on safety” before using the
unit.
Table of contents Page
1 Notes on safety 2
2 Overview 3
2.1 Control functions 4
3 How to obtain a correct treatment 5
3.1 Program 5
3.2 Settings 6
4 Preparation 6
4.1 Insert batteries 6
4.2 To use the massager for the first time 7
4.3 Attach Long Life pads 8
Page
5 Operation 9
5.1 Treatment program 9
5.2 Setting 9
6 End of treatment 10
7 Maintenance and Storage 10
7.1 When it is difficult to attach the pads 10
7.2 How to clean and store 11
8 Troubleshooting & Maintenance 12
8.1 Maintenance and spare parts 12
8.2 Replace batteries 12
9 Technical Data 14
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• The icons and warning signs are indicated here
for your safety and correct usage of the product
as well as to prevent injuries and/or damage to
properties.
• The icons and meanings are as follows:
1. Notes on safety
Examples of Icons
The icon indicates prohibitions (must not
do).
Matters involving certain prohibitions are
indicated by text or pictures in or near .
The icon to the left means “Prohibitions to
Disassemble”.
The icon indicates something that is
compulsory (must be observed).
Matters involving certain compulsory actions
are indicated by text or pictures in or near .
The icon to the left refers to “General
compulsory action”.
DANGER
This unit must not be used in
combination with the following medical
devices:
(1) Internally transplanted electronic
medical devices, e.g. pacemakers
(2) Electronic life support equipment,
such as respirators
(3) Electronic medical devices attached to
the body, such as electrocardiographs
Using this unit with other electronic
medical devices may cause erroneous
operation of those devices.
WARNING
Persons with the following conditions
must consult the doctor before using this
unit:
1) acute disease
2) malignant tumor
3) infectious disease
4) pregnancy
5) cardiac dysfunction
6) high fever
7) abnormal blood pressure
8) skin sensory disorders or skin
problems
9) receiving medical treatment, especially
those feeling discomfort
May cause an accident or ill health.
Do not use this unit near the heart, above
the neck, on the head, around the mouth
or on diseased skin.
May cause an accident or ill health.
- Application of electrodes near the thorax
may increase the risk of cardiac fibrillation.
CAUTION
If the unit is not functioning properly or
you feel discomfort, immediately stop
using the unit.
If you feel any problems with your body or
skin, consult the doctor and follow his/her
instructions.
If you want to move the Electrode Pad
to another region or your body during
treatment, be sure to turn off the power.
If not, you may receive a strong electrical
shock.
Do not try to attach the Pads to any
other person during the treatment.
You may receive strong electrical shock.
Do not start treatment while wearing an
electronic device.
The settings and timings of the device may
be affected.
Do not use this unit on infants or people
not capable of expressing their
intentions.
May cause an accident or ill health.
Do not use this unit in places with high
humidity such as bathrooms or while
taking a bath or shower.
You will receive a strong electrical shock.
Do not use this unit simultaneously with
other therapeutic device or in
combination with ointments including
spraytype ointments.
May cause discomfort or ill health.
- Simultaneous connection of a PATIENT to
a h.f. surgical EQUIPMENT may result in
burns at the site of the STIMULATOR
electrodes and possible damage to the
STIMULATOR.
- Operation in close proximity (e.g. 1 m) to a
shortwave or microwave therapy
EQUIPMENT may produce instability in
the STIMULATOR output.
Do not use this unit for purposes other
than treatment indicated in this manual.
May lead to accident, problems, or failure of
the unit.
Do not insert the electrode cord plug
into any place other than the electrode
cord jack of the main unit.
May cause an electric shock or accident.
Do not disassemble or remodel this unit.
May cause fire, trouble, or accident.
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2. Overview
AMain unit
BElectrode cord with safety plug
CRed connector
DWhite connector
ELong Life pads
FLong Life pads holder
GBattery compartment
HSoft fabric storage case
A
E
C
F
H
B
D
G
Do not use this unit while sleeping.
The main unit may develop trouble, or the
pad may move to an unexpected region
and cause ill health.
Do not use this unit while driving.
Receiving sudden strong stimulation may
lead to traffic accident or trouble.
Do not leave the Electrode Pad attached
to the skin after treatment.
Prolonged attachment may cause skin
irritation or infection.
Be careful not to allow any metal object,
such as a belt buckle or necklace to
come into contact with the Electrode
Pad during treatment.
You may receive a strong electrical shock.
Do not use cellular phones or other
electronic devices near this unit.
Do not use this unit to treat one region
for a long time (more than 30 minutes).
The muscles of the region under treatment
may be exhausted and may cause poor
physical condition.
Put the Long Life pads only on skin or
on the Long Life pads holder to avoid
damage of the adhesive surfaces of the
pads.
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JDisplay:
J1 Minutes to go during treatment,
J2 Blinking bar shows frequency,
J3 Indication Point,
J4 Indication Wide.
KLow frequency button: to select treatment for
stiff muscles.
LHigh frequency button: to select treatment for
acute pain.
MOn/Off and Adjustment Dial Switch: to turn
on/off the power and to adjust the intensity.
NDisplay shows on/off, intensity 0 to 10.
PPart of the body button: to select region.
QIndication Part of the body button (shoulder,
joint, arm, sole, leg, back).
RMassage button: to select favourite massage
method.
SIndication massage method (tap, knead, push
and rub).
THyper button: to select gradual increase of
intensity.
USoft button: to select soft stimulation.
VRepeat button: to repeat favourite stimulation.
WPoint/Wide:
W1 Left (red) Long Life pad,
W2 Pulse is applied on one point,
W3 Right (white) Long Life pad,
W4 Pulse is applied on a wider surface.
J
J3
J4
M
N
P
R
U
V
W
W3
J1
J2
K
L
Q
S
T
W2
W1
W4
2.1 Control functions
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3. How to obtain a correctt treatment
Medical Purpose
This Electronic Nerve Stimulator is intended to be used as a massager to relieve (muscle) pain, stiffness
and fatigue. The massaging effect is achieved by electronic stimulation of the nerves through electrode
pads placed on the skin. Various massage regions and treatment programs can be selected.
3.1 Program
To obtain a correct treatment you have available twelve treatment programs (see table below).
A treatment program runs during 15 minutes.
Complaint Program Effect
1Stiff muscles, Different combinations of vibrations on a low
numbness frequency to promote blood circulation. This program
is effective over a long period
2Acute pain High frequency vibrations relieve acute pain promptly
3Stiff shoulders Different vibrations promote blood circulation
and relieve fatigue
4Acute elbow High frequency vibrations relieve pain promptly
or knee pain
5Arm fatigue Different vibrations promote blood circulation
6Swelling and Different vibrations promote circulation of blood
foot fatigue and body fluid in the feet
7Swelling and Different vibrations promote circulation of blood
calf fatigue and body fluid in the limbs
8Back pain or Low frequency vibrations promote circulation of
lower back blood and relieve pain (neuralgia)
stiffness
9
10
Various symptoms Your favourite massage method (tap, knead, push
11 or rub) relieves stiffness, pain and fatigue
12
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4. Preparation3.2 Settings
Several settings can be made to get your favourite
treatment. You can compose your favourite treat-
ment at the beginning of the treatment program
and you can change it any time.
Hyper mode and Soft mode
You can select either Hyper mode or Soft mode.
Hyper mode increases gradual stimulation during
treatment and relieves stiffness effectively. Soft
mode stimulates without giving the feeling of
irritation and relieves stiffness comfortably.
Treatment surface
The treatment can be applied on a specific point
or to a wider surface of the Long Life pads.
Intensity
The intensity level of the massage is adjustable
with a dial switch.
Repeat
You can repeat your favourite stimulation. If the
repeat button is activated the device will repeat the
last part of the selected treatment program. The
device will continue with the treatment program if
the repeat button is deactivated.
4.1 Insert batteries
1Turn the On/Off-switch OFF.
2Remove the battery cover.
3Insert two batteries in the battery compartment.
Caution! Use two identical batteries!
1
10
1
OFF
"Click"
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4Put the battery cover on the battery
compartment.
4.2 To use the massager for the first time
Caution! Make sure the device is turned off and
that the batteries are inserted correctly!
1Pinch the safety plug and connect it to the main
unit.
2Take the Long Life pads out of the sealed package.
3Connect the electrode cord to the Long Life pads.
4Remove the film from the Long Life pads and
attach the pads directly onto your skin.
Caution! Do not damage the adhesive
surfaces of the Long Life pads!
OFF
"Click"
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4.3 Attach Long Life pads
Caution! Always use clean Long Life pads!
Caution! Do not fold the Long Life pads!
Caution! Avoid the Long Life pads touching any
metal object, such as belt buckle or necklace!
• Attach the Long Life pads on both shoulders
with the backbone in the centre.
• Attach the Long Life pads on both sides of the
joint where you feel pain.
• Attach both Long Life pads on the upper arm
where you feel pain.
• Attach one Long Life pad to the sole of the foot
that feels cold and the other one on the calf.
Caution! Do not simultaneously attach the
Long Life pads on the soles of both feet!
• Attach both Long Life pads on the calf where
you feel pain.
• Attach both Long Life pads on the lower back
with the backbone in the centre.
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Caution! Make sure that the components are
connected well and the Long Life pads are fixed
on the part of the body you wish to treat!
Caution! Do not pull on the electrode cord
during treatment!
Note: Turn Adjustment Dial-switch for intensity
(1-10) if required.
5.1 Treatment program
1Turn On/0ff-switch to level 1.
2Select one of the twelve programs according to
your complaint.
5.2 Setting
1Select Hyper mode or Soft mode.
For selecting Hyper mode press 3 seconds
Hyper button.
2Select point pulse or wide pulse.
3Press repeat button to have previous treatment
program start over.
Treatment program runs for 15 minutes.
5. Operation
1
10
1
ON
"Click"
1
1
1
10
1
1
10
1
1
10
1
1
10
1
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6. End of treatment
After 15 minutes the massager stops automatically.
1Stop program if required.
Caution! Stop treatment when you want to
change the treatment program!
Caution! Stop treatment when you want to move
a Long Life pad!
Caution! Stop treatment when you feel
discomfort with your body or skin!
Caution! Stop treatment when the massager is
not functioning properly or you feel discomfort!
2Remove the Long Life pads and place the pads
on the Long Life pads holder.
3Pinch the safety plug and remove it from the
main unit.
4Disconnect the electrode cord from the Long
Life pads.
7.1 When it is difficult to attach the pads
1Turn off the power, then remove the Electrode
Cord fromthe Pad.
2Wash the Pad softly with your fingertips under
slow running cold water for several seconds.
OFF
"Click"
7. Maintenance and Storage
Wash the Pads when the adhesive surface
becomes dirty and the Pads are difficult to
attach.
- Wash the Pads after every thirty uses. Pads can
be washed approximately ten times.
- Pads are consumables. Purchase the optional
Pads when the adhesive surface is damaged.
(Refer to page 14.)
* The life of Pads may vary by the frequency of
wash, skin condition, and storage state.
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3Sufficiently dry the Pads and let the adhesive
surface airdry.
* Do not wipe the adhesive surface with a
tissue paper or a cloth. If a tissue paper
isadhered to the adhesive surface by
accident, do not try to peel it off. Instead,
moisten the tissue paper with a small
amount of water, and then it will come off
easily.
4Lightly attach the Pad to the Electrode Holder
for storage.
7.2 How to clean and store
How to clean the Unit
• Keep the unit clean all the time.
• Be sure to turn off the Power and remove the
Electrode Cord from the Main Unit when
cleaning the unit.
• Wipe off stains on the Main Unit with a soft
cloth.
• If the unit is heavily stained, wipe it with a cloth
moistened with water or detergent. Wipe off the
unit with a dry cloth.
* Be careful so that no water should get into
the Main Unit.
Notes on care and storage
• Do not use benzine, thinner, or gasoline to
clean the unit.
• Do not store the unit under high temperature,
high humidity, and direct sunshine, or where
there is a lot of dust and/or corrosive gas.
• Keep the unit out of reach of children.
• If you are not going to use the unit for more
than three months, store the unit after removing
the batteries.
* If you do not observe the above-mentioned
notes or correct use of the unit, OMRON
cannot take responsibility on quality of the
unit.
• Put the massager and the pad holder in the
soft storage case.
• Store the massager on a dry, closed place with
a temperature between -20°C and 60°C.
Caution! Remove the batteries for a long time
storage (more than three months)!
-20
+60
• Do not use hot water, detergent, or chemicals such
as thinner or benzine.
• Do not scratch the adhesive surface with your nail
or a brush.
• Do not wash the Pads too long or too frequently.
• Do not store the Pads under high temperature, high
humidity, and direct sunshine.
* The adhesive surface may be damaged and the
Pads may last shorter.
* If the adhesive surface becomes sticky or the Pad
peels off, leave the Pad in the refrigerator (do not
freeze) overnight. The adhesion may be restored.
General advice from OMRON on the handling of Pads
Thinner
Gasoline
ELECTRONIC NERVE STIMULATOR
ELECTRONIC NERVE STIMULATOR
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Problem Cause Rectification
Device will not Batteries inserted in wrong Insert batteries in correct direction
turn on direction
Power turns off Long Life pads not attached Attach Long Life pads correctly to the skin
too soon correctly to the skin
Power turns off Batteries weak/exhausted Fit two new identical 1.5V alkaline
while using massager batteries type AAA LR03
Treatment period of 15 Restart treatment or turn off
minutes is over and power the massager
turns off automatically
Electrode cord broken Replace electrode cord
It is difficult to attach Transparent film not peeled off Peel off film on the adhesive
Long Life pad to surface of Long Life pad
the skin Long Life pad applied Sufficiently dry Long Life pad
immediately after washing
Adhesive surface of Long Replace Long Life pad
Life pad damaged
Adhesive surface Use of Long Life pad
of Long Life pad during perspiring
is sticky Long Life pad washed too Leave Long Life pad in
long and/or too frequently freezer for overnight
Long Life pads stored under
high temperature, high
humidity, direct sunshine
It is difficult to Long Life pads not attached Attach Long Life pad firmly
feel stimulation correctly to the skin to the skin
Long Life pads overlap each Reattach Long Life pads with no overlap
other
Electrode cord not Connect electrode cord correctly
connected correctly
Applied intensity too weak Increase the intensity by turning the dial switch
The skin turns Adhesive surface of Long Wash adhesive surface of Long Life pads
red or the skin Life pads dirty or dry softly with your fingertips for about 3 seconds
feels irritated under slow running water
Adhesive surface of Long Replace Long Life pads
Life pads damaged
8. Troubleshooting & Maintenance
8.1 Maintenance and spare parts
• Do not carry out repairs of any kind yourself. If
a defect occurs consult the customer service or
authorised dealer of Omron.
8.2 Replace batteries
• Remove the batteries from the battery
compartment and insert two new identical
batteries.
Attention! Disposal of used batteries should be
carried out in accordance with the national
regulations for the disposal of batteries.
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Important information regarding Electro
Magnetic Compatibility (EMC)
With the increased number of electronic devices
such as PCʼs and mobile (cellular) telephones,
medical devices in use may be susceptible to
electromagnetic interference from other devices.
Electromagnetic interference may result in
incorrect operation of the medical device and
create a potentially unsafe situation.
Medical devices should also not interfere with
other devices.
In order to regulate the requirements for EMC
(Electro Magnetic Compatibility) with the aim to
prevent unsafe product situations, the
EN60601-1-2:2007 standard has been
implemented. This standard defines the levels of
immunity to electromagnetic interferences as well
as maximum levels of electromagnetic emissions
for medical devices.
This medical device manufactured by OMRON
Healthcare conforms to this EN60601-1-2:2007
standard for both immunity and emissions.
Nevertheless, special precautions need to be
observed:
Do not use mobile (cellular) telephones and other
devices, which generate strong electrical or
electromagnetic fields, near the medical device.
This may result in incorrect operation of the unit
and create a potentially unsafe situation.
Recommendation is to keep a minimum distance
of 7 m. Verify correct operation of the device in
case the distance is shorter.
Further documentation in accordance with
EN60601-1-2:2007 is available at OMRON
Healthcare Europe at the address mentioned in
this instruction manual.
Documentation is also available at
www.omron-healthcare.com.
Correct Disposal of This Product
(Waste Electrical & Electronic Equipment)
This marking shown on the product or
its literature, indicates that it should not
be disposed of, with other household
wastes at the end of its working life. To
prevent possible harm to the
environment or human health from
uncontrolled waste disposal, please separate this
from other types of wastes and recycle it
responsibly to promote the sustainable reuse of
material resources.
Household users should contact either the retailer
where they purchased this product, or their local
government office, for details of where and how
they can take this item for environmentally safe
recycling.
Business users should contact their supplier and
check the terms and conditions of the purchase
contract. This product should not be mixed with
other commercial wastes for disposal.
This product does not contain any hazardous
substances.
Disposal of used batteries should be carried out in
accordance with the national regulations for the
disposal of batteries.
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Product Name OMRON E4 TENS massager
Model HV-F128-E
Power supply 3 VDC (2 1.5V alkaline batteries type AAA LR03)
Battery life Approx. 3 months: when used 15 minutes a day continuously
Approx. 2 months: when used 15 minutes a day continuously
under Hyper mode
Frequency generation Approx. 1 to 1200 Hz
Power consumption Approx. 85 mA
Maximum Output Voltage U ≤90 V (during 1 kΩload)
Maximum Output Current I ≤10 mA (during 1 kΩload)
Operating temperature and humidity 10°C to 40°C, 30 to 85% RH
Storage temperature and humidity -20°C to 60°C, 10 to 95% RH
Main unit dimensions 60 (W) x 199 (H) x 21 (D) mm
Weight Approx. 155 g (including batteries)
Package Contents Electrode cord
Set of Long Life pads
Batteries for monitor (2 identical 1.5V alkaline batteries type AAA LR03)
Long Life pad holder
Soft fabric case
Instruction manual
9. Technical Data
Disposal of this product and used batteries
should be carried out in accordance with
the national regulations for the disposal of
electronic products.
This product should not be used by persons
with medical implants, e.g. heart
pacemakers, artificial heart, lung or other
electronic life support systems.
Specifications may be changed without prior notice.
Available accessories / replacement parts:
1. Electrode Pads (Long Life Pads) with holder order no. 4928818-7
2. Electrode Cord (with safety plug) order no. 3027801-6
3. Electrode Pad Holder order no. 1614950-5
Type BF
Read the instructions in this manual
carefully.
This device fulfils the provisions of the EC directive 93/42/EEC (Medical Device Directive).
This OMRON product is produced under the strict quality system of OMRON HEALTHCARE Co., Ltd., Japan.
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Manufacturer OMRON HEALTHCARE Co., Ltd.
53, Kunotsubo, Terado-cho, Muko, Kyoto,
617-0002 JAPAN
EU-representative OMRON HEALTHCARE EUROPE B.V.
Scorpius 33, 2132 LR Hoofddorp, THE NETHERLANDS
www.omron-healthcare.com
Production facility OMRON (DALIAN) CO., LTD.
Dalian, CHINA
Subsidiary
OMRON HEALTHCARE UK LTD.
Opal Drive, Fox Milne, Milton Keynes, MK15 0DG, U.K.
OMRON MEDIZINTECHNIK
HANDELSGESELLSCHAFT mbH
John-Deere-Str. 81a, 68163 Mannheim, GERMANY
www.omron-medizintechnik.de
OMRON SANTÉ FRANCE SAS
14, rue de Lisbonne, 93561 Rosny-sous-Bois Cedex, FRANCE
Made in China

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