Omron SoftTouch HV-F158-E User manual

Electronic Nerve Stimulator
SoftTouch (HV-F158-E)
• Instruction Manual
• Mode d’emploi
• Gebrauchsanweisung
• Manuale di istruzioni
• Manual de instrucciones
• Gebruiksaanwijzing
IM-HV-F158-E-03-06/2010
1647385-0D
EN
FR
DE
IT
ES
NL
HV-F158 manual.book Page 1 Monday, June 14, 2010 2:46 PM

2
■Thank you for purchasing this OMRON
Electronic Nerve Stimulator.
■In order to use the device safely, read this
manual carefully before first use.
■Keep this manual in a convenient place for
future reference.
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 mas-
sage 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.
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3
EN
CONTENTS
Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Massage recommendations . . . . . . . . . . . . . 3
1. Information on Low-Frequency Therapy . 4
1.1 What is Low Frequency? . . . . . . . . . . . . . . . . . . .4
1.2 Mechanism of low-frequency electrotherapy . . . .4
2. Package Contents . . . . . . . . . . . . . . . . . . . 5
3. Notes on safety. . . . . . . . . . . . . . . . . . . . . . 6
4. Name and function of each section . . . . . 9
5. How to insert battery . . . . . . . . . . . . . . . . 10
6. Usage. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
7. Cleaning and storage. . . . . . . . . . . . . . . . 15
8. Trouble-shooting . . . . . . . . . . . . . . . . . . . 16
9. Specifications . . . . . . . . . . . . . . . . . . . . . . 19
Features
I. 3 Massage Modes
Pre-programmed massage mode for Shoulder, Waist and
Sole
II. Intensity Mode
Choose from 5 intensity levels to suit your needs
III. Jumbo Electrode Pads
The electrode pads are made larger for a bigger area of
contact, improving massage effectiveness.
Massage recommendations
Time: 10-15 min/time/region
Frequency: 1-2 times/day
Intensity: At a comfortable level
HV-F158 manual.book Page 3 Monday, June 14, 2010 2:46 PM

1.Information on Low-Frequency Therapy
4
1.1 What is Low Frequency?
A treatment method effectively using the physiological
action
Although we do not notice it, our bodies generate very weak
electricity from various parts of the body including the brain,
heart, muscles, and nerves. This electricity is called bioelec-
tricity. The bioelectricity plays an essential role for the normal
functioning of our bodies. Our bodies sensitively react to elec-
tric stimulation applied from the outside and cause various
changes. The method to treat abnormality of bioelectricity,
which is manifested as stiffness or pain, by effectively using
the above mentioned action is called electrotherapy, of which
low-frequency therapy is typical.
1.2 Mechanism of low-frequency electrotherapy
Pumping action of muscles
Muscles contract and relax with the flow of the low-frequency
current. When the muscle relaxes, a large amount of blood
flows in, and when the muscle contracts, the blood contain-
ing wastes is pumped out. With repeated actions, the blood
flows smoother and the blood circulation is improved.
1. Information on Low-Frequency Therapy
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2.Package Contents
5
EN
2. Package Contents
■Main
unit ■Electrode cord
Power
Intensity
Shoulder
Waist
Sole
■Jumbo Pad (2 pcs)
■Batteries for trial use
(2 pcs AAA size (R03) battery)
■Electrode Holder
■Instruction Manual
HV-F158 manual.book Page 5 Monday, June 14, 2010 2:46 PM

3.Notes on safety
6
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:
3. 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 fol-
lowing medical devices:
(1)Internally transplanted electronic medical devices,
e.g. pacemakers
(2)Electronic life support equipment, such as respira-
tors
(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.
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3.Notes on safety
7
EN
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.
Do not use this unit simultaneously with other thera-
peutic device or in combination with ointments includ-
ing 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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3.Notes on safety
8
CAUTION
If the unit is not functioning properly or you feel dis-
comfort, 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 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 infec-
tion.
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.
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4.Name and function of each section
9
EN
4. Name and function of each section
Electrode Cord Jack
Mode indicator
The blinking-light indicates
the operation mode.
The blinking pattern of the
lights corresponds to the
selected intensity level.
Power button
When the button is pressed, low
frequency massage will start.
Mode selection button
With this button you can select your pre-
ferred massage area, together with the
specific massage program for that area.
Intensity setting button
Set according to your needs at 5 different
levels.
Press for higher intensity.
Press for lower intensity.
HV-F158 manual.book Page 9 Monday, June 14, 2010 2:46 PM

5.How to insert battery
10
Remove the battery cover on the back. Make sure the signs correspond when inserting
batteries.
Reinstall the battery cover.
5. How to insert battery
During battery replace-
ment, replace both batter-
ies with new ones.
Dispose the used batteries
according to the local regu-
lations.
HV-F158 manual.book Page 10 Monday, June 14, 2010 2:46 PM

6.Usage
11
EN
■How to connect the
cord?
• Do not bend or pull the end of
the cord.
• When pulling out the cord from
the device, hold the plug and
pull.
• Replace the cord when broken
or damaged.
Make sure the unit is
switched OFF.
Connect the electrode
cord to the electrode
pads.
Insert the cord plug to
the jack.
6. Usage
Electrode cord
1
Power
Cord plug
Cord plug
Jack
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6.Usage
12
Refer to these illustrations for
proper placement of the pads at
the indicated areas.
Attach the
Jumbo-pads to
the area you
want to massage
When you use
it for the first
time, remove
the transparent
film.
Do not bend or
fold the pads.
2
Shoulder
massage
Waist
massage
Sole
massage
HV-F158 manual.book Page 12 Monday, June 14, 2010 2:46 PM

6.Usage
13
EN
When the unit is powered on,
the intensity setting will be at
the lowest level. You can
adjust this to your personal
preference.
Switch the power
ON, and select
massage mode
3
Power
Mode
selection
Intensity
setting
Select
Shoulder
Mode
This program effectively
massages the shoulder.
●It also changes between
tapping and kneading.
●The speed changes auto-
matically.
The shoulder mode lamp will
light up
Select
Waist
Mode
This program effectively
massages the waist.
●It also changes between
kneading and pushing.
●The speed changes auto-
matically.
The waist mode lamp will light up
Select
Sole
Mode
This program effectively
massages the sole.
●Kneading massage pro-
gram is applied.
●The speed changes auto-
matically.
The sole mode lamp will light up
Your last selected program will be activated auto-
matically after you switch the power ON. Intensity should start from the lowest level.
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6.Usage
14
When the
mode selec-
tion button is
pressed, the
mode will
change every
time you press it.
Press the power
button to turn the
unit OFF
Shoulder
Sole
Waist
4
Massage termination
The massage will stop automatically after 15 minutes.
When the battery is weak, the intensity will drop. Replace with new batteries according to the instruc-
tions on how to change the battery.
Intensity adjustment The intensity is adjustable in 5 steps, indicated by a blinking light.
Press for higher intensity.
Press for lower intensity.
Weak
Strong
The blinking pattern of the
light corresponds to the
selected intensity level.
HV-F158 manual.book Page 14 Monday, June 14, 2010 2:46 PM

7.Cleaning and storage
15
EN
■Cleaning the unit
Clean with a lightly moistened cloth (or a cloth soaked in a
neutral cleaning solution) and wipe gently.
Do not use chemicals (like thinner, benzene).
Do not let water get into the internal area.
■Jumbo Pad
When the Jumbo-pad gets dirty, it may affect the skin. In such a case wipe it
gently with a wet cloth. The stickiness will recover temporarily. Do not use too
much water.
Replacement of the Jumbo pads depends on each individual, but generally
after approximately 30 uses.
In case the pads are damaged, replace with the same Jumbo pads or with
OMRON Long-Life pads (E plus).
■Packing up
■Storage
• Do not keep the Jumbo pads and the unit in areas sub-
ject to direct sunlight, high temperature, humid area,
near to fire, vibration, or shock.
• Do not keep at places that can be easily reached by children.
• When not in use for a long period, to avoid liquid discharge
from batteries, remove the batteries before storage.
7. Cleaning and storage When you are packing
up, pull the cord plug
from the jack.
Leave the Jumbo-pad
that has been used
connected as it is to
the cord and attach to
the electrode holder
(one on each side).
Wrap up the cord
around the pad.
HV-F158 manual.book Page 15 Monday, June 14, 2010 2:46 PM

8.Trouble-shooting
16
8. Trouble-shooting
Problem Cause Solution
The intensity
is not felt.
Very weak
intensity level
Are both Jumbo-pads
attached to the body?
Attach both to the body.
Have you removed the
transparent film from the
Jumbo-pad?
Remove the transpar-
ent film.
Are the Jumbo-pads
stacked together? Do not stack them together.
Is the cord properly con-
nected?
Push right into the jack.
Is the intensity setting get-
ting weak?
Press the up button.
Are the batteries weak? Replace battery.
Skin
becomes
reddish.
The skin is
itchy.
Is massage time too long? Use 10-15 min.
Are the 2 Jumbo-pads
attached properly to the
body?
Attach 2 of them prop-
erly.
Is the Jumbo-pad surface
clean, or dry?
Wipe gently with a
piece of wet cloth.
Is the Jumbo-pad surface
worn out?
Replace with new ones.
No power
source
Polarities of battery (+ and
-) aligned in wrong direc-
tion.
Insert batteries in cor-
rect alignment.
Power cut off
Power cut off
during use.
Are the batteries weak? Replace batteries.
Is the cord broken? Replace cord.
Every 15 min. it stops
automatically.
When the above measures are not effective, then contact the nearest
OMRON dealer for check-up or repair.
HV-F158 manual.book Page 16 Monday, June 14, 2010 2:46 PM

8.Trouble-shooting
17
EN
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 inter-
ferences as well as maximum levels of electromagnetic emis-
sions for medical devices.
This medical device manufactured by OMRON Healthcare con-
forms 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 men-
tioned in this instruction manual.
Documentation is also available at www.omron-healthcare.com.
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8.Trouble-shooting
18
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 sep-
arate 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 environmen-
tally 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.
HV-F158 manual.book Page 18 Monday, June 14, 2010 2:46 PM

9.Specifications
19
EN
Specification may change without prior notice.
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.
Accessories/replacement parts
OMRON Jumbo Electrode Pads (set of 2), order no.:
1098186-1
OMRON Long Life Electrode Pads (set of 2, incl. holder),
order no.: 4928818-7
Electrode cord, order no.: 1097937-9
9. Specifications
Product name: OMRON Electronic Nerve Stimulator
Model: SoftTouch (HV-F158-E)
Power source: DC3V (2 pcs AAA size battery)
Battery life: New batteries will last for approx. 3 months
(when used for 15 minutes day, Waist Mode,
max. intensity).
Note: Supplied batteries are for trial use. These
batteries can run out within 3 months.
Output frequency: Approx. 1~100Hz
Maximum Output Voltage: U ≤70 V (during 1 kΩload)
Maximum Output Current: I ≤6 mA (during 1 kΩload)
Power control: 5 steps.
Operating temperature range: +10°C~+40°C
Storage temperature range: –20°C~+60°C.
Weight: Approx. 60g (incl. battery)
Outer dimension: Width 55 x Height 95 x Depth 18mm
HV-F158 manual.book Page 19 Monday, June 14, 2010 2:46 PM

9.Specifications
20
= Type BF
= Warning: read the instruction 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 medi-
cal implants, e.g. heart pacemakers, artificial heart,
lung or other electronic life support systems.
Made in China
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
Production
facility
OMRON (DALIAN) CO., LTD.
Economic & Technical Development Zone Dalian
116600, CHINA
Subsidiary
OMRON HEALTHCARE UK LIMITED
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
EC REP
HV-F158 manual.book Page 20 Monday, June 14, 2010 2:46 PM