Gima GIMA 9 TENS User guide

Gima S.p.A. - Via Marconi, 1 - 20060 Gessate (MI) Italy
Italia: tel. [phone] - fax [phone]
Export: tel. [phone]/221/225 - fax [phone]
[e-mail] - [e-mail]

PROFESSIONAL MEDICAL PRODUCTS

www.gimaitaly.com

TENS 9 PROGRAMMI - 2 CANALI
TENS 9 PROGRAMMES - 2 CHANNELS
TENS 9 PROGRAMMES - 2 CANAUX
TENS 9 PROGRAMAS - 2 CANALES
TENS 9 PROGRAMAS - 2 CANAIS
TENS 9 PROGRAMME - 2 KANÄLE
TENS 9 PROGRAMÓW - 2 KANAŁY

ΠΡΟγΡάμμάτά TENS 9 - 2 κάνάλιά

Manuale d’uso - User manual - Manuel de l’utilisateur
Guía de Uso - Guia para utilização - Gebrauchsanweisung

Instrukcja obsługi - Οδηγίες χρήσης

ATTENZIONE: Gli operatori devono leggere
e capire completamente questo manuale
prima di utilizzare il prodotto.
ATTENTION: The operators must carefeully
read and completely understand the present
manual before using the product.
AVIS: Les opérateurs doivent lire et bien
comprendre ce manuel avant d’utiliser le produit.
ATENCIÓN: Los operadores tienen que leer
y entender completamente este manual antes
de utilizar el producto.
ATENÇÃO: Os operadores devem ler e entender
completamente este manual antes de usar o produto.
ACHTUNG: Die Bediener müssen vorher
dieses Handbuch gelesen und verstanden
haben, bevor sie das Produkt benutzen.

UWAGA: przed rozpoczęciem użytkowania wyrobu operatorzy muszą
przeczytać podręcznik i upewnić się, iż wszystko to, co jest w nim napisane
jest dla nich jasne i zrozumiałe.
ΠΡΟΣΟΧΗ: Οι χειριστές αυτού του προϊόντος πρέπει να διαβάσουν και να
καταλάβουν πλήρως τις οδηγίες του εγχειριδίου πριν από την χρήση του.

M-28342-I-GB-F-E-P-D-PL-GR-Rev.1.02.16

28342 / AD-2026

Andon Health Co., Ltd
No. 3 JinPing, YaAn Road, Nankai District, Tianjin 300190, China
Made in P.R.C.

Lotus Global Co., Ltd.
1 Four Seasons Terrace West Drayton,
Middlesex, London, UB7 9GG, United Kingdom

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INDEX

INTRODUCTION OF TENS ..................................................................... 17

1. Theory of therapy ............................................................................... 17

2. Why consider digital pain relief? ........................................................ 17

3. How does the Digital Pain Relief (TENS) work? ................................. 18

CONTENTS AND DISPLAY INDICATORS .............................................. 18

INTENDED USE ...................................................................................... 20

CONTRAINDICATION ............................................................................. 20

PRODUCT DESCRIPTION...................................................................... 20

SPECIFICATIONS ................................................................................... 21

NOTICE .................................................................................................. 21

SETUP AND OPERATING PROCEDURES ............................................. 22

1. Battery loading ................................................................................... 22

2. Attachment of electrode lead wires .................................................... 23

3. Operating instructions ........................................................................ 23

TROUBLESHOOTING ............................................................................ 24

MAINTENANCE ...................................................................................... 25

EXPLANATION OF SYMBOLS ON UNIT ................................................ 25

ELECTROMAGNETIC COMPATIBILITY INFORMATION ........................ 26

WARRANTY INFORMATION .................................................................. 29

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INTRODUCTION OF TENS

1. Theory of therapy

Transcutaneous electrical nerve stimulation (TENS) is a non-invasive
technique in which a low-voltage electrical current is delivered through wires
from a small power unit to electrodes located on the skin. Electrodes are
temporarily attached with paste in various patterns, depending on the
specic condition and treatment goals. TENS is often used to treat pain,
as an alternative or addition to pain medications. Therapy sessions may last
from minutes to hours. The use of electrical stimulus for pain relief was
popularized in the 19th century and became widespread in the 1960s
and 1970s using battery power.

Transcutaneous electrical nerve stimulation (TENS) was rst introduced into
current clinical practice following Melzack and Wall’s gate control theory
of pain in 1965. Davis (1993) and Lewith (1984) explain the gate control
theory of pain as follows. An area of the dorsal horn of the spinal cord,
known as the substantia gelatinosa, acts as a gate to nociceptive impulses.

It receives myelinated nerve bres (A bres), the largest being A bres,
and small non-myelinated nerve bres (C bres).
If pain impulses pass along A (nemyelinated) bres and C bres rather than
along A bres, the gate is opened, and the patient perceives pain. If A bre
transmission of impulses is greater, the gate may be closed.

There is also evidence that the TENS machine enhances the production of
the body’s own natural pain killing substances: endorphins and encephalins.
Human body produces endorphins and encephalins, which are opiate-like
substances to counter the pain. Low frequency stimulation causes
the release of the endorphins and encephalins.

2. Why consider digital pain relief?

Pain is a warning signal – we need these signals to tell us that something
may be wrong with our body. Without it, we may do not know that part
of our body might be damaged, thereby damaging them further. However,
once we have identied damage, pain serves little purpose. In the case
of chronic, regular pain it can signicantly interfere with daily activities
and the quality of life.

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3. How does the Digital Pain Relief (TENS) work?

Digital Pain Relief (TENS) works by passing harmless electrical signals into
the body from its pads. This relieves pain in two ways:

• Firstly, it blocks the body’s pain signals. These are normally transmitted

from the area of damage through the nerve bers to the brain, TENS
interrupts these pain signals.

• Secondly, TENS stimulates the body’s production of endorphins-its own

natural painkillers.

CONTENTS AND DISPLAY INDICATORS

18

1 Mainframe

3 Instruction book 4 Electrode Pads (two pairs) 5 wire( two)

2 Battery

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ON/OFF: Press the “ON/OFF” button to turn on/turn off the unit.
CH1+: Press the “CH1+”button to increase the CH1’s intensity
from 0 to 9.
CH1-: Press the “CH1-”button to decrease the CH1’s intensity
from 9 to 0.
CH2+: Press the “CH2+”button to increase the CH2’s intensity
from 0 to 9.
CH2-: Press the “CH2-”button to decrease the CH2’s intensity
from 9 to 0.
MODE Press the MODE button to changing-timer mode
or changing-mode mode .Then use “MODE+” or “MODE-” button
to adjust current mode. CH1’s mode will be adjusted when CH1
was selected, CH2’s mode will be adjusted when CH2 was
selected.

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INTENDED USE

AD-2026 is a dual channels TENS device which is effective in relieving pain.

Treatment effect

• Relieving lower-back pain

• Stimulate muscles

• Promoting blood circulation

• Eliminate tiredness

CONTRAINDICATION

The device is safe for all people, with the following exceptions
or the people who are receiving physiotherapy.
1 People with acute disease
2 Cancer patients
3 People with infectious skin wounds
4 People who are in menstrual period or expectant mother
5 People with heart disease
6 People with high fever
7 People with abnormal blood pressure
8 People who have no feeling about their skins or people with abnormal skins
9 People with abnormal feeling of their body except the above cases.

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PRODUCT DESCRIPTION

The AD-2026 is a battery operated pulse generator that sends electrical
impulses through electrodes to the body and reaches the underlying nerves
or muscle group. The device is provided with two controllable output
channels, each independent of each other. An electrode pair can be
connected to each output channel.
The electronics of the AD-2026 Digital create electrical impulses whose
Intensity, Pulse Width, Pulse Rate may be altered according to the program.
Press buttons are very easy to use and the panel cover prevents changes
in the setting.

The AD-2026 corresponds to the below standards:

IEC 60601-1:2005/EN 60601-1:2006/AC:2010 (Medical electrical equipment

-- Part 1: General requirements for basic safety and essential performance).
EN 60601-1-2:2007 (Medical electrical equipment - Part 1-2: General
requirements for basic safety and essential performance) - Collateral
standard: Electromagnetic compatibility - Requirements and tests.

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SPECIFICATIONS

1. Product name: TENS Device

2. Model: AD-2026

3. Number of treatment program: 9

4. Range of pulse frequency: 2-80Hz

5. Range of output voltage: 30V±20% (500)

6. Classication: Internally powered, Type BF applied part, IPX0,
No AP or APG,Continuous operation

7. Machine size: Approx.128mm × 56mm × 16mm

8. Weight: Approx.67.4g (exclude batteries)

9. Power source: batteries: 2 ×1.5V SIZE AAA

10. Environmental temperature for operation: 5°C~40°C

11. Environmental humidity for operation: ≤80%

12. Environmental temperature for storage and transport: -20°C~55°C

13. Environmental humidity for storage and transport: ≤95%

14. Environmental pressure: 80KPa~105KPa

15. Battery life: Approx.2 months with alkaline batteries and 30-min.
usage per day.

Note: These specications are subject to change without notice.

NOTICE

1. If you feel uncomfortable or abnormal of skin, please stop using.

Consult with doctors and follow doctor’s advice.

2. Please don’t use it in the bathroom or other place with high humidity.

3. Please don’t use it when driving or sleeping.

4. Do not make any sharp kinks in the connecting leads or electrodes.

5. Please don’t use it for other purposes except treatment.

6. Please do not throw battery into re.

7. Do not use the device if you are connected to, or in the vicinity of,

high-frequency surgical or industrial equipment. This may cause burn
injuries on the skin under the electrodes, as well as problems with
the stimulator.

8. Observe caution when using the device in the immediate vicinity

of cellular phones that are switched on.

9. Do not use the device in the direct vicinity of short-wave or microwave

equipment, since this may affect the output power of the stimulator.

10. This TENS Device is designed for adults and should never be used

on infants or young children. Consult your physician or other health care
professionals before use on older children.

11. The device might not meet its performance specications or cause safety

hazard if stored or used outside the specied temperature and humidity
ranges in specications.

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z

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12. Remove the batteries if the device will not be used for a month or more

to avoid damage of battery leakage.

13. Please do not use it at the heart, private parts or skin disease parts.

14. User who with implanted electronic equipment, such as pacemakers

and intracardiac debrillators has not got the doctor’s advice must
not use the device. Pregnant women should not use the device during
the rst trimester, and should always consult a doctor, midwife
or physiotherapist prior to use.

15. 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.

16. Operation in close proximity (e.g. 1 m) to a shortwave or microwave

therapy EQUIPMENT may produce instability in the STIMULATOR output.

17. Application of electrodes near the thorax may increase the risk of cardiac

brillation.

18. Please do not knock down, repair, and rebuild it privately.

19. Please do not use the electrode pads other than supplied by the

manufacturer, otherwise it may bring biocompatible hazard and might
result in measurement error.

20. Please do not share the electrode pads with other infective person

to avoid cross-infection.

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SETUP AND OPERATING PROCEDURES

1. Battery loading

a. Open battery cover at the back of the device.
b. Load two “AAA” size batteries. Please pay attention to polarity.
c. Close the battery cover.

Rechargeable batteries are not suitable for this device.

Remove the batteries if the monitor will not be used for

a month or more to avoid relevant damage of battery leakage.

Please do not mix use new and old batteries or different

type of batteries.

Please do not throw battery into re.
The device and the batteries, must be disposed of according

to local regulations at the end of their usage.

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2. Attachment of electrode lead wires

a. The wires provided with the AD-2026 insert into the jack sockets

located on top of the device. Holding the insulated portion of the
connector, push the plug end of the wire into one of the jacks;
one or two sets of wires may be used.

b. After connecting the wires to the stimulator, attach each wire to an

electrode.

Use care when you plug and unplug the wires. Jerking the wire

instead of holding the insulated connector body may cause wire
breakage.

c. Place the electrode on your body as directed by your physician.
Clean the wires by wiping with a damp cloth.

Coating them lightly with talcum powder will reduce tangling

and prolong life.

3. Operating instructions

a. Press the “ON/OFF” button, the device will be put on, the LCD light all

display for 1 second, then the device go into standby mode and wait
for your settings.

b. First, set the time of therapy. Press the MODE button to changing-timer

mode which is ‘clock’ sign in LCD. Then press the MODE+ button
to increase the therapy time or press the MODE- button to decrease
the therapy time.

The timer can be change from 1 minute to 30 minutes, defaulted time

is 15 minutes.
c. Second, select the mode of therapy. Press the MODE button to changing­ mode mode which is ‘hand’ sign in LCD, then like changing of timer, press

the MODE+ button or MODE- button to select an expected mode.

9 modes can be selected from 1 to 9 and return to mode 1.
d. As followed, set the intensity and the device start to treat.

Note: different person need different intensity, so you must increase

the intensity from 0 to 9 slowly and carefully, stop to increase when you

feel comfortable.
e. In treating, the ‘second’ sign in LCD ashes until the time of therapy

is exhausted.
f. After treatment, the device will be shut off automatically.
g. You should hold the plug when pulling it out. Please do not pull the wire.
h. Please use clear water to wash or use wet cloth (instead of facial tissue)

to gently wipe up the electrodes when cleaning them.
Do not use brush or ngernail to do it lest that the surface of the

electrodes should get scratched.

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TROUBLESHOOTING

PROBLEM POSSIBLE CAUSE SOLUTION

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You have no feeling
of stimulus.

Stimulus is weak.

The skin becomes red.

Are the batteries exhausted?

Are the batteries properly
loaded?

Is the wire properly
connected?

Have you turned off the tran­sparent protection lm over the
electrode pad?

Do the electrode pads
closely stick to the skin?

Are the electrode pads
overlapped?

Are the electrode pads dirty?

Is intensity too weak?

Are the electrode pads
position proper?

Is the therapeutic time too
long?

Are the electrode pads too dry?

Do the electrode pad closely
stick to the skin?

Replace the batteries.

Correctly load the batteries.

Firmly connect the wire.

Tear off the protection.

Closely stick the electrode pad to
the skin.

Separate the electrode pad
and stick them to the skin gain.

Please clean the electrode pad.

Turn the intensity regulation
dial to regulate it.

Change the position of the
electrode pad.

Control it within 10~15 minutes
a time.

Please gently wipe them up with
wet cloth and then use them again.

Please closely stick the
electrode pad to the skin.

Power sources cut off
in the therapeutic process.

Are the electrode pads dirty?

Are the surface of the
electrode pads scratched?

Have the electrode pads come
off the skin?

Are the wire disconnected?

Have the batteries been
exhausted?

Please clean the electrode pad.

Please replace them with new
electrode pad.

Turn off the power and stick the
electrode pad rmly to the skin.

Turn off the power and connect
the wire.

Please replace them with
new ones.

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MAINTENANCE

1. Do not drop this device subject it to strong impact.

2. Avoid high temperature and solarization. Do not immerse the device
in water as this will result in damage to it.

3. If this device is stored near freezing, allow it to acclimate to room
temperature before use.

4. Do not attempt to disassemble this device.

5. If you do not use the device for a long time, please remove the batteries.

6. If the device becomes dirty, please clear it with a soft dry cloth.
Do not use any abrasive or volatile cleaners.

7. No component can be maintained by user in the device.
The circuit diagrams, component part lists, descriptions, calibration
instructions, or other information which will assist the user’s appropriately
qualied technical personnel to repair those parts of equipment which
are designated repairably can be supplied by us.

8. In order to ensure that the electrodes adhere as long as possible,
they should be cleaned carefully with a damp, lint-free cloth.

9. After use, stick the electrodes onto the backing lm.

10. Electrode Pads is consumptive, so when the electrodes still
not adhere rmly, you must buy a new pair of electrode-pad.

EXPLANATION OF SYMBOLS ON UNIT

Symbol for “THE OPERATION GUIDE MUST BE READ”
(The sign background colour: blue. The sign graphical symbol: white)

Symbol for “WARNING”(The sign background colour: yellow)
Symbol for “TYPE BF APPLIED PARTS”
Symbol for “ENVIRONMENT PROTECTION

Waste electrical products should not be disposed of with household
waste. Please recycle where facilities exist. Check with your local Au­thority or retailer for recycling advice”.

Symbol for “KEEP AWAY FROM SUNLIGHT”
Symbol for “KEEP DRY”
Symbol for “MANUFACTURER”
Symbol for “COMPILES WITH MDD93/42/EEC REQUIREMENTS”

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Symbol for “DATE OF MANUFACTURE”

SN Symbol for “SERIAL NUMBER”

Symbol for “EUROPEAN REPRESENTATION”

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ELECTROMAGNETIC COMPATIBILITY
INFORMATION

Table 1
For all ME EQUIPMENT and ME SYSTEMS

Guidance and manufacture’s declaration - electromagnetic emissions

The AD-2026 is intended for use in the electromagnetic environment
specied below. The customer or the user of the AD-2026 should assure
that it is used in such an environment.

Emissions test

Compliance

Electromagnetic environment-guidance

26

RF emissions
CISPR 11

RF emissions CISPR 11

Harmonic emissions
IEC 61000-3-2

Voltage uctuations/icker
emissions IEC 61000-3-3

Group 1

Class B

Not applicable

Not applicable

The AD-2026 uses RF energy only for its
internal function. Therefore, its RF emissions
are very low and are not likely to cause any
interference in nearby electronic equipment.

The AD-2026 is suitable for use in all
establishments other than domestic and those
directly connected to the public low-voltage
power supply network that supplies buildings
used for domestic purposes.

Table 2
For all ME EQUIPMENT and ME SYSTEMS

Guidance and manufacturer’s declaration - electromagnetic immunity

The AD-2026 is intended for use in the electromagnetic environment
specied below. The customer or the user of the AD-2026 should assure
that it is used in such an environment.

IMMUNITY test

Electrostatic
discharge (ESD)
IEC 61000-4-2

Power frequency
(50/60 Hz)
magnetic eld
IEC 61000-4-8

IEC 60601
test level

± 6 kV contact
± 8 kV air

3 A/m

Compliance
level

± 6 kV contact
± 8 kV air

3 A/m

Electromagnetic
environment-guidance

Floors should be wood, concrete
or ceramic tile. If oors are covered
with synthetic material, the relative
humidity should be at least 30%.

Power frequency magnetic elds
should be at levels characteristic
of a typical location in a typical
commercial or hospital environment.

Note: UT is the a.c. mains voltage prior to application of the test level.

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Table 3
For ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING

Guidance and manufacturer’s declaration - electromagnetic immunity

The AD-2026 is intended for use in the electromagnetic environment
specied below. The customer or the user of the AD-2026 should assure
that it is used in such an environment.

IMMUNITY test

IEC 60601
test level

Compliance
level

Electromagnetic environment ­guidance

Radiated RF
IEC 61000-4-3

3 V/m 80 MHz
to 2.5 GHz

3 V/m

Portable and mobile RF
communications equipment should be
used no closer to any part of the
AD-2026, including cables, than
the recommended separation distance
calculated from the equation applicable
to the frequency of the transmitter.

Recommended separation
distance:

d = 1.2 √ P
d = 2.3 √ P

Where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter
manufacturer and d is the
recommended separation distance
in meters (m).
Field strengths from xed RF
transmitters, as determined by
an electromagnetic site survey,a
should be less than the compliance
level in each frequency range.
Interference may occur in the
vicinity of equipment marked
with the following symbol:

80 MHz to 800 MHz
800 MHz to 2,5 GHz

b

Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation

is affected by absorption and reection from structures, objects and people.
a. Field strengths from xed transmitters, such as base stations for radio (cellular/cordless)

telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV
broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to xed RF transmitters, an electromagnetic site survey should be considered.
If the measured eld strength in the location in which the AD-2026 is used exceeds the
applicable RF compliance level above, the AD-2026 should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary,
such as re-orienting or relocating the AD-2026.
b. Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than [V1] V/m.

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Table 4
For ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING

Recommended separation distances between portable
and mobile RF communications equipment and the AD-2026

The AD-2026 is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of the
AD-2026 can help prevent electromagnetic interference by maintaining
a minimum distance between portable and mobile RF communications
equipment (transmitters) and the AD-2026 as recommended below,
according to the maximum output power of the communications equipment.

Rated maximum
output power
of transmitter
W

0,01 0,12 0,12 0,23

0,1 0,38 0,38 0,73

1 1,2 1,2 2,3
10 3,8 3,8 7,3
100 12 12 23

For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in meters (m) can be determined using the equation applicable
to the frequency of the transmitter, where P is the maximum output power rating
of the transmitter in watts (W) according to the transmitter manufacturer.
Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range
applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation
is affected by absorption and reection from structures, objects and people.

Separation distance according to frequency of transmitter m

150 kHz to 80 MHz 800 MHz to 2,5 GHz

d = 1.2 √ P d = 2.3 √ Pd = 1.2 √ P

80 MHz to 800 MHz

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Disposal: The product must not be disposed of along with other
domestic waste. The users must dispose of this equipment by
bringing it to a specific recycling point for electric and electronic
equipment. For further information on recycling points contact
the local authorities, the local recycling center or the shop where
the product was purchased. If the equipment is not disposed
of correctly, fines or penalties may be applied in accordance
with the national legislation and regulations.

GIMA WARRANTY CONDITIONS

Congratulations for purchasing a GIMA product.This product meets high
qualitative standards both as regards the material and the production.
The warranty is valid for 12 months from the date of supply of GIMA.
During the period of validity of the warranty, GIMA will repair and/or replace
free of charge all the defected parts due to production reasons.
Labor costs and personnel traveling expenses and packaging not included.
All components subject to wear are not included in the warranty.
The repair or replacement performed during the warranty period shall
not extend the warranty. The warranty is void in the following cases: repairs
performed by unauthorized personnel or with non-original spare parts,
defects caused by negligence or incorrect use. GIMA cannot be held
responsible for malfunctioning on electronic devicesor software due to
outside agents such as: voltage changes, electro-magnetic elds, radio
interferences, etc.
The warranty is void if the above regulations are not observed and if the serial
code (if available) has been removed, cancelled or changed.
The defected products must be returned only to the dealer the product was
purchased from. Products sent to GIMA will be rejected.

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Functions

ANNEX A