E4 Tens
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E4 Tens
E4 Tens Massager
Low-Frequency Electronic Pulse Massager
Instruction manual
Gebrauchsanweisung
Gebruiksaanwijzing
page 01
Seite 17
pagina 33
Mode d’emploi
Manuale de instructone
Manual de instrucciones
page 49
pagina 65
pagina 81
IM-HV-F128-E-03-06/2010
1628187-0F
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Table of contents
Page
1 Notes on safety
2 Overview
2.1 Control functions
3 How to obtain a correct treatment
3.1 Program
3.2 Settings
4 Preparation
4.1 Insert batteries
4.2 To use the massager for the first time
4.3 Attach Long Life pads
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.
2
3
4
5
5
6
6
6
7
8
Page
5 Operation
5.1 Treatment program
5.2 Setting
6 End of treatment and care
7 Storage
8 Troubleshooting and maintenance
8.1 Maintenance and spare parts
8.2 Replace batteries
9 Technical data
9
9
9
10
11
12
12
12
14
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.
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1. Notes on safety
• 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:
Examples of Icons
icon indicates prohibitions (must not
The
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.
2
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.
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.
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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.
2. Overview
A
B
E
F
H
C
D
G
A
B
C
D
Main unit
Electrode cord with safety plug
Red connector
White connector
E Long Life pads
F Long Life pads holder
G Battery compartment
H Soft fabric storage case
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2.1 Control functions
J
J3
J1
J4
J2
K
M
L
N
Q
P
S
R
T
U
V
W2
W
W1
W3
W4
4
J Display:
J1 Minutes to go during treatment,
J2 Blinking bar shows frequency,
J3 Indication Point,
J4 Indication Wide.
K Low frequency button: to select treatment for
stiff muscles.
L High frequency button: to select treatment for
acute pain.
M On/Off and Adjustment Dial Switch: to turn
on/off the power and to adjust the intensity.
N Display shows on/off, intensity 0 to 10.
P Part of the body button: to select region.
Q Indication Part of the body button (shoulder,
joint, arm, sole, leg, back).
R Massage button: to select favourite massage
method.
S Indication massage method (tap, knead, push
and rub).
T Hyper button: to select gradual increase of
intensity.
U Soft button: to select soft stimulation.
V Repeat button: to repeat favourite stimulation.
W Point/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.
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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
1
Program
Effect
Stiff muscles,
Different combinations of vibrations on a low
numbness
frequency to promote blood circulation. This program
2
Acute pain
High frequency vibrations relieve acute pain promptly
3
Stiff shoulders
Different vibrations promote blood circulation
is effective over a long period
and relieve fatigue
4
Acute elbow
High frequency vibrations relieve pain promptly
or knee pain
5
Arm fatigue
6
Swelling and
Different vibrations promote circulation of blood
foot fatigue
and body fluid in the feet
7
8
Different vibrations promote blood circulation
Swelling and
Different vibrations promote circulation of blood
calf fatigue
and body fluid in the limbs
Back pain or
Low frequency vibrations promote circulation of
lower back
blood and relieve pain (neuralgia)
stiffness
9
10
Various symptoms
11
Your favourite massage method (tap, knead, push
or rub) relieves stiffness, pain and fatigue
12
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4. Preparation
3.2 Settings
Several settings can be made to get your favourite
treatment. You can compose your favourite treatment at the beginning of the treatment program
and you can change it any time.
4.1 Insert batteries
OFF
Hyper mode and Soft mode
"Click"
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.
1 Turn the On/Off-switch OFF.
Treatment surface
The treatment can be applied on a specific point
or to a wider surface of the Long Life pads.
2 Remove the battery cover.
Intensity
1
1
10
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.
6
3 Insert two batteries in the battery compartment.
Caution ! Use two identical batteries!
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4 Put the battery cover on the battery
compartment.
2 Take the Long Life pads out of the sealed package.
4.2 To use the massager for the first time
OFF
"Click"
3 Connect the electrode cord to the Long Life pads.
4 Remove 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!
Caution ! Make sure the device is turned off and
that the batteries are inserted correctly!
1 Pinch the safety plug and connect it to the main
unit.
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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 both Long Life pads on the upper arm
where you feel pain.
• Attach the Long Life pads on both shoulders
with the backbone in the centre.
• 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 the Long Life pads on both sides of the
joint where you feel pain.
• Attach both Long Life pads on the lower back
with the backbone in the centre.
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5. Operation
5.2 Setting
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!
1
1
1
1
10
1 Select Hyper mode or Soft mode.
For selecting Hyper mode press 3 seconds
Hyper button.
10
Note: Turn Adjustment Dial-switch for intensity
(1-10) if required.
5.1 Treatment program
ON
1
1
1
"Click"
10
2 Select point pulse or wide pulse.
1 Turn On/0ff-switch to level 1.
1
1
1
10
1
3 Press repeat button to have previous treatment
program start over.
1
10
2 Select one of the twelve programs according to
your complaint.
Treatment program runs for 15 minutes.
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6. End of treatment and care
After 15 minutes the massager stops automatically.
OFF
3 Pinch the safety plug and remove it from the
main unit.
"Click"
1 Stop 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!
4 Disconnect the electrode cord from the Long
Life pads.
5 Wash the pads softly with your fingertips under
slow running water for about 3 seconds.
Caution ! Do not use hot water!
2 Remove the Long Life pads and place the pads
on the Long Life pads holder.
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6 Sufficiently dry the Long Life pads.
Caution ! Do not wipe the adhesive surfaces!
Caution ! Let the adhesive surfaces of the
Long Life pads air-dry!
Caution ! Adhesive surface sides up during
drying!
9 Use a soft, slightly moistened cloth to clean the
main unit.
Caution ! Do not wash and do not use petrol,
thinners or similar solvents!
7. Storage
7 Connect the electrode cord on the Long Life
pads and place the pads on the pad holder.
+60
-20
8 Wrap the electrode cord around the pad holder.
• Put the massager and the pad holder in the
soft storage case.
• Store the massager on a dry, closed place with
a temperature between -20º and 60ºC.
Caution ! Remove the batteries for a long time
storage (more than three months)!
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8. Troubleshooting & Maintenance
Problem
Device will not
turn on
Power turns off
too soon
Power turns off
while using massager
It is difficult to attach
Long Life pad to
the skin
Adhesive surface
of Long Life pad
is sticky
It is difficult to
feel stimulation
The skin turns
red or the skin
feels irritated
Cause
Batteries inserted in wrong
direction
Long Life pads not attached
correctly to the skin
Batteries weak/exhausted
Attach Long Life pads correctly to the skin
Treatment period of 15
minutes is over and power
turns off automatically
Electrode cord broken
Transparent film not peeled off
Long Life pad applied
immediately after washing
Adhesive surface of Long
Life pad damaged
Use of Long Life pad
during perspiring
Long Life pad washed too
long and/or too frequently
Long Life pads stored under
high temperature, high
humidity, direct sunshine
Long Life pads not attached
correctly to the skin
Long Life pads overlap each
other
Electrode cord not
connected correctly
Applied intensity too weak
Adhesive surface of Long
Life pads dirty or dry
Adhesive surface of Long
Life pads damaged
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.
12
Rectification
Insert batteries in correct direction
Fit two new identical 1.5V alkaline
batteries type AAA LR03
Restart treatment or turn off
the massager
Replace electrode cord
Peel off film on the adhesive
surface of Long Life pad
Sufficiently dry Long Life pad
Replace Long Life pad
Leave Long Life pad in
freezer for overnight
Attach Long Life pad firmly
to the skin
Reattach Long Life pads with no overlap
Connect electrode cord correctly
Increase the intensity by turning the dial switch
Wash adhesive surface of Long Life pads
softly with your fingertips for about 3 seconds
under slow running water
Replace Long Life pads
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 PC’s 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.
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.
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.
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9. Technical Data
Product Name
Model
Power supply
Battery life
OMRON E4 TENS massager
HV-F128-E
3 VDC (2 1.5V alkaline batteries type AAA LR03)
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 kΩ load)
Maximum Output Current
I ≤ 10 mA (during 1 kΩ load)
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
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.
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.
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.
24, Yamanouchi Yamanoshita-cho, Ukyo-ku, Kyoto, 615-0084 JAPAN
EU-representative
OMRON HEALTHCARE EUROPE B.V.
Kruisweg 577, 2132 NA Hoofddorp, THE NETHERLANDS
www.omron-healthcare.com
EC
REP
Production Facility
OMRON (DALIAN) CO., LTD.
Economic & Technical Development Zone Dalian 116600, CHINA
OMRON HEALTHCARE UK LIMITED
Opal Drive, Fox Milne Milton Keynes, MK15 0DG U.K.
Subsidiary
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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