TensCare MT9000 Instruction Manual

1

Instruction Manual

for the

T.I.M.E. Multitherapist

Model MT9000

www.tenscare.co.uk

2

This manual is valid for the MT9000 Combo TENS/EMS/IF/MIC Stimulator

This user manual is published by Shenzhen Dongdixin Technology Co.. Ltd
Shenzhen Dongdixin Technology Co., Ltd does not guarantee its contents and reserves
the right to improve and amend it at any time without prior notice. Amendments may
however be published in new editions of this manual.

All Rights Reserved. Rev. V1.1 02010

Declaration of conformity:

Shenzhen Dongdixin Technology Co., Ltd declares that the device complies with
following normative documents:
IEC6060I-1, IEC6060I-1-2, IEC60601-2-10, IEC60601 -1 -4, ISO10993-5, ISO10993-10,
ISO10993-1

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TABLE OF CONTENTS

I. SAFETY INFORMATION 4

1.1 General description

1.2 Medical background

1.3 Indications for use
1 .4 Contraindications

1.5 Warnings, Cautions, Adverse Reactions

2. PRESENTATION 11

2.1 Front and Rear panel

2.2 LCD display

3. SPECIFICATION 13

3.1 Accessories

3.2 Technical information

3.3 The waveforms of the stimulation programs

4. INSTRUCTION FOR USE I9

4.1 Battery

4.2 Connect electrodes to lead wires

4.3 Connect lead wires to device

4.4 Electrode

4.5 Turn ON

4.6 Select the Therapeutic Mode

4.7 Steps to set a new program

4.8 Adjust Channel Intensity

4.9 Safety Lock Feature

4.10 Stop the treatment

4.11 Turn OFF

4.12 Low battery indicator

5. PROGRAM 29

6. CLEANING AND CARE 30

6.1 Tips for skin care

6.2 Cleaning the device

6.3 Electrodes

6.4 Cleaning the patient leads

6.5 Maintenance

7. TROUBLESHOOTING 33

8. STORAGE 34

9. DISPOSAL 34

10.ELECTROMAGNETICCOMPATIBILITY(EMC)TABLES 35

11. NORMALIZED SYMBOLS 37

12. WARRANTY 38

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1. SAFETY INFORMATON

1.1 General
MT9000 Combo is a portable electrotherapy device featuring four therapeutic modes:

Transcutaneous Electrical Nerve Stimulation (TENS),Electrical Muscle
Stimulation(EMS),lnterferential(lF), and Microcurrent(MIC) which are used for pain relief
and electrical muscle stimulation. The stimulator sends gentle electrical current to
underlying nerves and muscle group via electrodes applied on the skin. The parameters

of device are controlled by the “press” buttons, Its intensity level is adjustable according

to the needs of patients.

1.2 Medical background

EXPLANATION OF PAIN

Pain is a warning system and the body’s method of telling us that something is wrong.
Pain is important; without it abnormal conditions may go undetected, causing damage
or injury to vital parts of our bodies. Even though pain is a necessary warning signal of
trauma or malfunction in the body, nature may have gone too far in its design.
Aside from its value in diagnosis, long -lasting persistent pain serves no useful purpose.
Pain does not begin until coded message travels to the brain where it is decoded,
analyzed, and then reacted to. The pain message travels from the injured area along
the small nerves leading to the spinal cord, Here the message is switched to different
nerves that travel up the spinal cord to the brain. The pain message is then interpreted,
referred back and the pain is felt.

EXPLANATION OF TENS

Transcutaneous Electrical Nerve Stimulation (TENS) is a noninvasive, drug free method
of controlling pain. TENS uses tiny electrical impulses sent through the skin to nerves to
modify your pain perception. TENS does not cure any physiological problem; it only
helps control the pain. TENS does not work for everyone; however, in must patients it is
effective in reducing or eliminating the pain, allowing for a return to normal activity.

5

EXPLANATION OF EMS

Electrical Muscle Stimulation 1EMS) is an internationally accepted and proven way of
treating muscular injuries. It works by sending electronic pulses to the muscle needing
treatment; this causes the muscle to exercise passively. It is a product derived from the
square waveform(ladder-shaped).Through the square wave pattern it is able to work
directly on muscle motor neurons. This device has low frequency and this in conjunction
with the square wave pattern alIows direct work on muscle groupings. This is being
widely used in hospitals and sports clinics for the treatment of muscular injuries and for
the re-education of paralyzed muscles, to prevent atrophy in affected muscles and
improvinq muscle tone and blood circulation.

EXPLANATION OF IF

Interferential Stimulation (IF) is an anti-inflammatory based treatment modality.
Interferential stimulation is characterized by two alternating-current sine waves or
square waves of differing frequencies that “work” together to produce an interferential
current that is also known as a beat pulse or alternating modulation frequency. One of
the two currents is usually held at 4000 Hz, and the other can beheld constant or varied
over a range of 4001 to 4, 100 Hz. Because of the frequency, the interferential wave
meets low impedance when crossing the skin to enter deep into soft tissues. The
interferential currents reportedly can stimulate sensory, motor, and pain fibers. These
large impulse fibers interfere with the transmission of pain messages at the spinal cord
level. This deep tissue penetration stimulates parasympathetic nerve fibers by
increased blood flow and edema reduction. It utilizes the low electric current to stimulate
muscle nerves to achieve the symptomatic relief of chronic intractable pain, post­traumatic pain, and post-surgical pain.

EXPLANATION OF MICROCURRENT
Microcurrent stimulation is a type of therapy in which very low current is sent into the
cells of the body.
Microcurrent is a very faint current that is so small it is measured in millionths of an amp
(Microamps). Human cells generate a current that is in the microamp range which is
why you can’t feel it-the current is so low it doesn’t stimulate the sensory nerves.

Microcurrent is a physiological electric modality that increases ATP (energy) production
in the cells of your body. This dramatically increases the tissues healing rate. The
immediate response to the correct microcurrent frequency suggests that other
mechanisms are involved as well. The exact effects or changes in the tissue are
unmistakable: scars will often suddenly soften, trigger points often became less painful
within minutes when the “correct” frequency is applied. In many situations the changes
seem to be long lasting and in many cases permanent.

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1.3 Indications for use

MT9000 ComboTENS/EMS/IF/MIC Stimulator may be used for the following conditions:

1) Symptomatic relief of chronic intractable pain

2) Post traumatic pain

3) post surgical pain

4) Relaxation of muscle spasm.

5) Increase of blood flow circulation
B) Prevention or retardation of disuse atrophy

7) Muscle re-education

8) Maintaining or increasing range of motion.

9) Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
IMPORTANT SAFETY INFORMATNION

Read instruction manual before operation. Be sure to comply with all
“Contraindications”, Warnings”, “Cautions” and “Adverse reactions” in the manual.
Failure to follow instructions can cause harm to user or device.

1.4 Contraindications

I) The device should not be used for symptomatic local pain relief unless etiology is
established or unless a pain syndrome has been diagnosed.

2) This device should not be used when cancerous lesions are present in the treatment
area.

3) Stimulation should not be applied over swollen, infected, inflamed areas or skin
eruptions (e.g. phlebitis, thrombophlebitis, varicose veins, etc.).

7

4) Electrodes must not be applied to sites that might cause current/stimulation to flow
through the carotid sinus region (anterior neck) or transcerebrally (through the head).

5) Do not use this device if the patient has a demand-type cardiac pacemaker or any
imnplanted defibrillator,

6) This device should not be used over poorly innervated areas.

7) Epilepsy

8) Serious arterial circulatory problems in the lower limbs

9) Abdominal or inguinal hernia

10) Do not use this device if you have heart disease without consulting your physician.

1.5. Warnings,Cautions, and Adverse Reactions
WARNINGS:

1) This device should he used only under the continued supervision of a licensed

physician.

2) The long-term effects of chronic electrical stimulation are unknown. Electrical
stimulation devices do not have any curative value.

3) TENS is a symptomatic treatment and, as such, suppresses the sensation of pain,
which would otherwise serve as a protective mechanism.

4) Safety has not been established for the use of therapeutic electrical stimulation
during pregnancy. Do not use during pregnancy unless directed by your physician.

5) Electrical stimulation is not effective for pain of central origin.

6) Electronic monitoring equipment (such as ECG monitors) may not operate properly
when electrical stimulation is in use.

7) Stimulation should not be applied over the carotid sinus nerves, particularly in
patients with a known sensitivity to the carotid sinus reflex.

8) Stimulation should not be applied over the neck or mouth: Severe spasm of the
laryngeal and pharyngeal muscles may occur and the contractions may be strong
enough to close the airway or cause difficulty in breathing.

9) Stimulation should not be applied transthoracically . The introduction of electrical
current into the heart may cause cardiac arrhythmias.

8

10) Stimulation should not take place while the user is connected to high- frequency
surgical equipment. It may cause burn injuries in the skin under the electrodes, as well
as problems with the stimulator.

11) Do not use the stimulator in the vicinity of shortwave or microwave therapy
equipment, since this may affect the output power of the stimulator.

12) Never use in environments with high humidity such as in the bathroom or when
having a bath or shower.

13) Caution should be used in applying electrical stimulation to patients suspected of
having heart disease. Further clinical data is needed to show there are no adverse
results,

14) Never use near the heart. Stimulation electrodes should never be placed anywhere
on the front of the thorax (marked by ribs and breastbone), but above all not on the two
large pectoral muscles. Here it may increase the risk of ventricular fibrillation and lead to
cardiac arrest.

15) Electrodes should not be placed over the eyes, in the mouth, near the genitals or
internally.

16) Never use on areas of the skin which lack normal sensation

17) Apply the electrodes to clean, dry, and unbroken skin only.
I8) Keep electrodes separate during treatment, electrodes in contact with each other
could result in improper stimulation or skin inflammation.

19) Keep the stimulator out of reach of children.

20) Consult your doctor if you are in any doubt whatsoever.
CAUTIONS:

1) In the USA, Federal law restricts this device to sale by or on the order of a physician.

2) For single patient use only.

3) Be aware of the contraindications.

4) This stimulator not intended for unattended, personal use by patients who are
noncompliant or emotionally disturbed, or have dementia or low IQ.

5) Read, understand, and observe the warnings, cautions and operating instructions.
Know the limitations and hazards associated with using any device. Observe the
precautionary and operational decals placed on the unit. Always follow the operating
instructions prescribed by your healthcare practitioner.

9

6) The indications for use are listed above. Use for any other purpose may be
dangerous.

7) Do not use this device for undiagnosed pain syndromes until you have consulted a
physician.

8) Patients with an implanted electronic device, such as a cardiac pacemaker,
implanted defibrillator, or any other metallic or electronic device should not use this
device without first consulting a doctor.

9) Stimulation delivered by this device may be sufficient to cause electrocution.
Electrical current of this magnitude must not flow through the thorax or across the chest
because it may cause a cardiac arrhythmia.

10) Do not place electrodes on the front of the throat as spasm of the Laryngeal and
Pharyngeal muscle may occur. Stimulation over the carotid sinus (neck region) may
close the airways, make breathing difficult, and may have adverse effects on the heart
rhythm or blood pressure.

11) Do not place electrodes on your head or at any sites that may cause the electrical
current to flow transcerebrally (through the head).

12) Patients with heart disease, epilepsy, cancer or any other health condition should
not use this device without first consulting a physician.

13) Some patients may experience skin irritation or hypersensitivity due to the electrical
stimulation or silicone rubber. If a rash develops or pain persists, discontinue use and
consult a doctor.

14) Electrode placement and stimulation settings should be based on the guidance of
prescribing practitioner.
IS) Effectiveness is highly dependent upon patient selection by a person qualified in the
management of pain afflicted patients.

16) Isolated cases of skin irritation may occur at the site of the electrode placement
following long-term application. If this occurs, discontinue use and consult your
physician.

17) The electrodes are only to be placed on healthy skin. Avoid skin irritation by
ensuring that good contact is achieved between electrodes and skin.

18) If the stimulation levels are uncomfortable or become uncomfortable, reduce the
stimulation Intensity to a comfortable level and contact your physician if problems
persist.

10

19) This device should not be used while driving, operating machinery, close to water,
or during any activity in which involuntary muscle contractions may put the user at
undue risk of injury.

20) Never use the device in rooms where aerosols (sprays) are used or pure oxygen is
being administered.

21) Do not use it near any highly flammable substances, gases or explosives.

22) Do not use this device at the same time as other equipment which sends electrical
pulses to your body.

23) Do not confuse the electrode cables end contacts with your headphones or other
devices, and do not connect the electrodes to other devices.

24) Do not use sharp objects such as pencil point or ballpoint pen to operate the buttons
on the control panel.

25) Inspect leads and associated connectors before each use.

26) Turn the device off before applying or removing electrodes.

27) Electrical stimulators should be used only with the leads and electrodes
recommended for use by the manufacturer

28) This device has no AP/APG protection. Do not use it in the presence of explosive
atmosphere end flammable mixture.

Adverse Reactions:

1) Skin irritation from the electrode gel is a potential adverse reaction. If skin irritation
occurs, discontinue use and consult your physician.

2) If the stimulation levels are uncomfortable, reduce the stimulation Intensity to a
comfortable level and contact your physician if problems persist.

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2. PRESENTATION

2.1 Front and Rear panel

1) Output socket: Electric signal is output after connection of the cable and
adhesive electrodes. Channel 1.

2) Output socket: Electric signal is output after connection of the cable and
adhesive electrodes. Channel 2.

3) [] Increases the output intensity of Channel 1.

In Setting state, adjusts the Program and the waveform parameters.

4) [▼] decreases the output intensity of Channel 1.

In Setting state, adjusts the Program and the waveform parameters.
Unlocks the keypad.

5) [ M ]. Therapeutic mode selection
Stop the treatment.
Exit setting mode to return to the user interface.

6) LCD display: Shows the operating state of the device.

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7) [] Increases the output intensity of Channel 2.
In Setting state, adjusts the Program and the waveform parameters.

8) [▼] decreases the output intensity of Channel 1.
In Setting state, adjusts the Program and the waveform parameters.
Unlocks the keypad.

9) Parameter Selection [S]: press the button to enter setting state: you can
select the difference parameters in conjunction with [] and [].
Press [M] to leave Setting state.

10) Press [ ] button to turn on the device,
Press [ ]: button and hold for approx.3 seconds to turn off the device.

11) Belt Clip

12) The battery compartment cover for opening

13) Adapter Receptacle

2.2 LCD display

1) Display therapeutic Mode

2) Display therapeutic Program for TENS and EMS

3) Display therapeutic Program for IF and MIC
or
Display the cycle time for TENS, IF and MIC Mode in setting state.

4) Timer symbol

5) EMS ramp up and ramp down time

5) Pulse Width indicator

7) Channel 1 label

8) Channel 1 output intensity
Also displays waveform pulse width or EMS contraction (working) time in setting state.

9) EMS contraction (working) time indicator

10) Keypad LOCK indicator

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11) Pulse Rate indicator

12) Channel 2 output intensity.
Also displays pulse rate or EMS relaxation time in setting state.

13) Channel 2 indicator

14) EMS relaxation time indicator

15) Display treatment time or EMS ramp up and ramp down time

16) Low-battery indicator

3. SPECIFICATION

3.1 Accessories

No

DESCRIPTION

Qty

I

Electrical stimulator device

I piece

2

Electrodes Leads

2 pieces

3

1.5”x1 .5”Adhesive Electrodes

4 pieces

4

9V Alkaline battery, type 6LR61

I piece

5

Instruction Manual

I piece

6

Carrying case

I piece

3.2 Technical information

Channels

Dual, isolated between channels

Power supply

9.0V DC Alkaline LR61 battery
Adaptor output:9.0 Vdc, 800mA (optional)

Operating
conditions

5C to 40C (41 F to 104F ) with a relative humidity of
30%- 75%,atmospheric pressure from 700 to 1060 Hpa

Storage
conditions

-10C to 5OC (14F to 122F) with a relative humidity of
10%-90%,atmospheric pressure from 700 to 1060 Hpa

Dimensions

4.5x2.55x0.9 inches (L*W*H)

Weight

0.28 lbs (With battery)

Tolerance

There may be a 5% tolerance of all setting and 10% tolerance of
output of intensity.

Timer

Adjustable, from 1 to 60 minutes or continuous.
Adjustable by 1 minute each step.
Automatic treatment time countdown.

Electrode
Detection
Function

The amplitude level will be reset to 0mA when the amplitude level is
12mA or greater and an open circuit is detected on either channel.

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Technical specifications for Transcutaneous Electrical Nerve Stimulator (TENS)
mode

Technical specifications for Electrical Muscle Stimulator (EMS) mode

Waveform

Mono-phase square pulse wave

Pulse amplitude

Adjustable, 0-105mA peak at 1000 ohm Load each channel.
1 mA/Step.

Pulse Width

Adjustable, from 50 to 300µS, 10µS/step

Pulse Rate

Adjustable,, from 1 to 150Hz, 1 Hz/step

contraction time

Adjustable,1-30 seconds , 1 Sec. / step

Relaxation
(OFF) time

Adjustable. 0—60 seconds , 1 Sec./ step

Ramp time

Adjustable. 1-6 seconds, 1 Sec. / step, The “On” time will increase
and decrease with the setting value.

Synchronous (S)

Stimulation of both channels occurs synchronously. The “ON’ time
includes “Contraction”, ‘Ramp Up” and “Ramp Down” time,
ON TIME =Contraction+ Ramp up+ Ramp down

Alternate (A)

The Stimulation of CH2 will occur after the 1st working of CH1 is
completed. OFF time should = or > ON time
ON TlME=Contraction + Ramp up + Ramp down.
OFF TIME>ON TIME

Delay {D)

The Stimulation of the CH2 will occur after the 1st working of CH1 is
started + Delay Time. Delay time is adjustable from 1 to 10 Sec.
ON TlME=Contraction + Ramp up + Ramp down

Waveform

Mono-phase square pulse wave

Pulse amplitude

Adjustable, 0-105mA peak at 1000 ohm Load each channel.
1 mA/Step.

Pulse Width

Adjustable, from 50 to 300uS, 10uS/step

Pulse Rate

Adjustable,, from 1 to 150Hz, 1 Hz/step

Burst (B)

Burst rate: Adjustable, 0.5-5Hz, 0.1 Hz/step
Pulse width adjustable, 50-300µS
Frequency fixed = 100 Hz

Normal (N]

The pulse rate and pulse width are adjustable.
Generates continuous stimulation based on the setting value.

Pulse Width
Modulation (M)

The pulse width is automatically adjusted in a cycle time
The pulse width is decreased from its original setting to 60% in its
set cycle time, and then increased from 60% to its original setting in
next set cycle time. In this program, pulse rate (1 to 150Hz), pulse
width (50 to 300µS) and cycle time (5 to 30sec) are fully adjustable.

Pulse Rate
Modulation(M1)

The pulse rate is automatically varied in a cycle time. The pulse rate
is decreased from its original setting to 60% in setcycle time, and
then increased from 60% to its original setting in next cycle time. In
this program, pulse rate (1 to 150Hz), pulse width (50 to 300µS)
and cycle time (5 to 30sec) are fully adjustable.

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Technical specifications for Interferential (IF) mode

Waveform

Bi-phase square pulse

Pulse
amplitude

Adjustable, 0—70mA peak to peak at 1000 Ω Load each channel,
1 mA/Step

Pulse Rate

Channel I — Fundamental frequency: 4000 Hz fixed
Channel 2-- Selectable frequency: 4001 to 4150 Hz
Interference frequency: 1 to 150Hz

Phase
Width

125 uS

P1

The pulse rate of the CH1I is fixed at 4000Hz; CH2 pulse rate is increased
from 4001 Hz to 4010 Hz in a cycle time, and then decreased from
4010Hz to 4001Hz in next set cycle time. In this program CH2 interference
frequency is varied from 1 Hz to 10Hz, cycle time (5 to 30 sec) is fully
adjustable. CH 2 pulse rate =4000Hz+ Interference frequency

P2

The pulse rate of the CH1 is fixed at 4001 Hz, CH2 pulse rate is increased
from 4001Hz to 4150Hz in a cycle time, and then decreased from 4150Hz
to 4001 Hz in next set cycle time. In this program, CH2 interference
frequency is varied from 1 Hz to 150Hz, cycle time (5 to 30 Sec) is fully
adjustable. CH 2 pulse rate = 4000Hz + Interference frequency

P3

The pulse rate of the CH1 is fixed at 4000Hz; CH2 pulse rate is increased
from 4050Hz to 4150Hz in a cycle time and then decreased from 4100Hz
to 4000Hz in next set cycle time. In this program, CH2 interference
frequency is varied from 80Hz to 150Hz, cycle time (5 to 30 sec) is fully
adjustable, CH 2 pulse rate=4000Hz+ Interference frequency

P4

The pulse rate of the CH1 is fixed at 4000Hz; CH2 pulse rate is
automatically varied in a cycle time. Interference frequency is increased
from its original setting to 60% in set cycle time, and then decreased from
60% to its original setting in next set cycle time

16

Technical specifications for Microcurrent (MIC) mode

Waveform

Mono-phase square pulse wave

Pulse amplitude

Adjustable, 0.00-0.70mA peak at 1000 Ohm load each channel.

0.01 mA/Step

Pulse Width
(PW.)

Adjustable, from 2 to 200 ms, 1 ms/step
P.W.< 1/2xP R.

Pulse Rate
(P R)

Adjustable, from 1 to I50 Hz, I Hz/step
PR<1/2xPW.

Constant(P1)

Constant stimulation based on setting value. Only pulse width, pulse
rate and timer are adjustable in this program. ‘Constant’ is equal to
the ‘Normal” mode of a TENS therapeutic mode.

Pulse Width
Modulation (P2)

The pulse width is automatically varied in a cycle time
The pulse width is decreased from its original setting to 60% in set
cycle time, and then increased from 60% to its original setting in next
set cycle time. In this program, pulse rate (1 to150Hz), pulse width (2
to 200ms) and cycle time (5 to 30 sec) are fully adjustable.

Pulse Rate
Modulation (P3)

The pulse rate is automatically varied in a cycle time. The pulse rate
is decreased from its original setting to 60% in set cycle time, and
then increased from 60% to its original setting in the next set cycle
time. In this program, puIse rate (1 to 150Hz), pulse width (2 to
200ms) and cycle time (3 to 30 sec) are fully adjustable.

17

3.3 Waveforms of the stimulation programs
Burst (B)

Burst Frequency 7 pulses per burst

Normal (N)

Pulse Width Modulation

cycle time

Pulse Rate Modulation

cycle time

18

Synchronous (S)

ON TI ME OFF TIME

Alternate (A)

Delay (D)

Delay time

19

Interferential

Microcurrent (Constant)

4. INSTRUCTIONS FOR USE

4.1 Battery

4.1.1 Check/Replace the battery

When the battery needs to be changed:.

1) Slide the battery compartment cover and open.

2) Pull up the battery following the direction of the
arrow shown above

3) Insert the 9V battery into the battery compartment

4) Make sure you are installing the battery correctly.
Be sure to match the positive and negative ends of
the battery to the marking in the battery compartment

5) Press and pull down following the direction of the arrow shown above

6) Replace the battery compartment cover and press to close.

4.1.2 Disposal of battery
Spent batteries do not belong in the household waste.
Dispose of the battery according to the current federal, state and local
regulations. As a consumer, you are obligated by law to return spent
batteries.

20

Caution:

1) Battery may be fatal if swallowed. Therefore, keep the battery and the product
out of the range of children. If a battery was swallowed, consult a physician
immediately.

2) If a battery has leaked, avoid contact with skin, eyes and mucus membranes,
Rinse the affected spots with lots of clear water immediately and contact a
physician right away.

3) Battery may not be charged, dismantled, thrown into fire or short-circuited.

4) Protect battery from excess heat; Take the batteries out of the product if they
are spent or in case you no longer use the article. This prevents damage caused
by leaking battery.

5) Always replace with the same type battery.

4.2 Connect electrodes to lead wires

Insert the lead wire connector into electrode connector (standard 2mm female
connection). Make sure that no bare metal of the pins is left exposed.

Caution:
Always use electrodes that meet local safety standard:
CE mark: with IEC/EN6060I-1, ISO10993-1/-5/-10 and lEC/EN60601-1-2
FDA: 510(K) certified.

4.3 Connect lead wires to device

1) Ensure that the device is completely turned OFF.

2) The wires provided with the system insert into the jack sockets located on top of the
device.

3) Holding the insulated portion of the connector, push the plug end of the wire into one
of the jacks (see drawing). One or two sets of wires may be used.

21

4) This device has two output sockets
controlled by Channel 1 and Channel 2 at the
top of the unit. For IF you must use both
channels. For other modes, you may choose to
use one channel with one pair of lead wires, or
both channels with two pairs of lead wires.
Using both channels gives the user the
advantage of stimulating two different areas at

the same time.

Caution

Do not insert the plug of the patient lead wire into any AC power supply socket.

4.4 Electrodes

4.4.1 Electrode options

The electrodes are disposable and should be routinely replaced when they start to lose
their adhesive nature. If your electrodes stop sticking properly, order replacement
electrodes. To maintain optimal stimulation and to prevent skin irritation, follow the
application procedures outlined in the electrode packing,

4.2 Place electrodes on skin
Apply electrodes to the exact site indicated by your physician or therapist. Before
applying electrodes be sure the skin surface is thoroughly cleaned and dried. Make sure
the electrodes are pressed firmly to the skin and that there is good contact between the
skin and the electrodes.

22

Caution:

1) Wash, degrease, and dry the skin before applying the self-adhesive electrodes.

2) Do not turn on the device when the self-adhesive electrodes are not positioned
on the body.

3) Never remove the self-adhesive electrodes from the skin while the device is
still turned on.

4) Do not use electrodes smaller than 4cmx4cm

4.4.3 Electrode placement

The positioning of electrodes can be one of the most important parameters in achieving
success with therapy. It is important that the physician tries various styles of electrode
pIacement to find which method best fits the needs of the individual patient.
Every patient responds to electrical stimulation differently and their needs may vary
from the conventional settings suggested here. If the initial results are not positive,
speak to your physician about alternative stimulation settings and/or electrode
placements. Once an acceptable placement has been achieved, mark down the
electrode sites and the settings, so the patient can easily continue treatment at home.

4.5 Turn on

Before using the device tor the first time you are strongly advised to take
careful note of the counter-indications and safety measures detailed at
the beginning of this manual (safety information).

In order to turn on the device, keep the [ ] button pressed down until the operation
page appears on the screen.

23

4.6 Select the Therapeutic Mode
There are 4 therapeutic modes available —TENS, IF, MIC, and EMS
The therapeutic mode can be selected by pressing the [M] control.

Caution:

Consult your physician for your suitable therapeutic mode.

4.7 Steps to Set a New Program

4.7.1 TENS Setting

Press the [S] button to enter the setting state.
Pressing the [S] button repeatedly cycles through the available options
The settings can he adjusted according to the following steps:

1) Set the Therapeutic Program
There are 4 programs in TENS therapeutic mode available -Burst (B), Normal
(N), Pulse Width Modulation (M), and Pulse Rate Modulation (M1). The
therapeutic program can be selected by pressing the [▲] and [▼] buttons. When
you select a program, the box around the symbol for that program will flash

2) Set Cycle Time (Optional)
Cycle time is adjustable from 5 to 30 seconds. Only Modulation programs (M and
M1) have this parameter setting. Press [S] button cycle to enter this menu, and
then press the [▲] and [▼] buttons to adjusting the setting.

3) Set Timer
Press [S] button cycle to enter this setting. The treatment time is adjustable from
1 to 60 minutes or Continuous. Press [▲] or [▼] buttons.
To select Continuous, when the display shows 60 minutes press [▲] button.
Stimulation output will be shut off when time is up.

24

4) Set Pulse Width
Pulse Width is adjustable from 50 uS to 300 uS.
Press [S] button cycle to enter this menu, then press [▲] or [▼] buttons to adjust
the setting.

5) Set Pulse Rate

Pulse rate is adjustable from 1 Hz to 150 Hz (0.5 Hz to 5Hz for Burst).
Press [S] button cycle to enter this menu, and then press [▲] or [▼] button to
adjust the setting.

4.7.2 EMS Setting
Press the [S] button to enter the setting state. Pressing the [S] button repeatedly cycles
through the available options.
The settings can be adjusted according to the following steps

1) Set the Therapeutic Program
There are 3 programs in EMS therapeutic mode available -Delay, Synchronous
and Alternate.
The program can be selected by pressing the [▲] and [▼] buttons. When you
select a program, the box around the symbol for that program will flash.

2) Set Timer
Press [S] button cycle to enter this setting. The treatment time is adjustable from
1 to 60 minutes or Continuous. Press [▲] or [▼] button to adjust setting. To
select Continuous, when the display shows 60 minutes press [▲] button.
Stimulation output will be shut off when time is up.

3) Set Pulse Width
The pulse width determines the length of time each electrical pulse is applied
through the skin, which affects the strength and sensation of the stimulation.
Press [S] button cycle to enter this setting. The pulse width is adjustable from 50
to 300 uS.
Press [▲] or [▼] buttons to adjust the setting.

25

4) Set Pulse Rate
The pulse rate determines how many electrical impulses are applied through
the skin each second. Press [S] button cycle to enter this menu. By pressing the
[▲] and [▼] buttons to adjusting the setting. The pulse rate is adjustable from
1Hz to 150 Hz.

5) Set DelayTime (Optional)
Delay time is adjustable from 1 to 10 seconds. Only the Delay therapeutic
program has this parameter setting. Press [S] button cycle to enter this menu,
and then press [▲] and [▼] buttons to adjusting the setting.

6) Set Ramp Time
The ramp time controls the time that the output current takes to increase from 0
to the set level, and from the set value back to to 0. When the ramp time is set,
each contraction may be ramped up and down so that the signals come on and
off gradually and smoothly. The ramp time is adjustable from 1 to 6 seconds.

7) Set Contract Time
The Contract Time controls the time of stimulation. The contraction time can be
adjusted. Press [S] button cycle to enter this menu, and then press the [▲] and
[▼] button to adjusting the setting. Stimulation from both channels is cycled on
and of by the contraction and relaxation settings. The range is adjustable from 1
to 30 seconds.

8)

Caution:

Contract time does not include the ramp up and ramp down time,

ON time = Ramp up + Contract time + Ramp down.

26

9) Set Relaxation (OFF) time
The OFF Time controls the duration of the relaxation interval. The relaxation
time can be adjusted. Press [S] button cycle to enter this menu, and then press
the [▲] and [▼] buttons to adjust the setting. Both channels’ stimulation is
cycled on and off by the contraction and relaxation settings. The range is
adjustable from 0 to 60 seconds.
In Alternate program, the OFF Time should equal, or be more than, the ON
Time. (OFF TIME>ON TIME)

4.7.3 IF Setting
Press the [S] button to enter the setting state. Pressing the [S] button repeatedly cycles
through the available options.
The settings can be adjusted according to the following steps:

1) Set the Therapeutic Proqram
There are 4 programs in IF therapeutic mode available.

The therapeutic program can be selected by pressing the [▲] and [▼] button.

The mode you selected will show up on the top of liquid crystal display.

2) Set Timer
Press [S] button cycle to enter this setting. The treatment time is adjustable
from 1 to 60 minutes or Continue. Press [▲] or [▼] control to adjust setting. To

select Continuous, when the display shows 60 minutes press [▲] button.

Stimulation output will be shut off when time is up.

3) Set Interference frequency (optional)
Channel 1 has 4000 Hz fixed Fundamental Frequency.

Channel 2 has selectable frequency from 4001 to 4150 Hz:
Interference frequency is adjustable from 1 Hz to 150Hz.
Only “P4” has this parameter setting.
Press [S] button cycle to enter this menu, and then press the [▲] and [▼]

button to adjusting the setting.

27

4) Set Cycle Time

Cycle time is adjustable from 5 to 30 seconds.
Press [S] button cycle to enter this menu, and then press the [▲] and [▼]

button to adjusting the setting.

4.7.4. MICROCURRENT Setting

Press the [S] button cycle to enter the setting state. The settings can be adjusted
according to the following steps:

1) Set the Therapeutic Program
There are 3 programs in MIC therapeutic program available
—Constant, Pulse Width Modulation, and Pulse Rate Modulation.
The therapeutic program can be selected by pressing the [▲] and [▼] button.
The mode you selected will show up on the top of liquid crystal display.

2) Set Timer
Press [S] button cycle to enter this setting. The treatment time is adjustable
from 1 to 60 minutes or Continuous. Press [▲] or [▼] button control to adjust
setting. You can set the timer to “Continuous” mode by pressing the [▲] control
when it shows 60 minutes. Its output will be shut off when time is up.

3) Set Pulse Width
Pulse Width is adjustable from 2ms to 200ms. Press “S” button cycle to enter
this menu, then press [▲] or [▼] button to adjust the setting.

4) Set Pulse Rate
Pulse rate is adjustable from 1 Hz to 150Hz. Press [S] button cycle to enter this
menu, and then press [▲] or [▼] button to adjust the setting.

28

5) Set Cycle Time (Optional)
Cycle time is adjustable from 5 to 30 seconds. Only modulation mode has this
parameter setting. Press [S] button cycle to enter this menu and then press [▲]
or [▼] button to adjust the setting.

4.8 Adjusting Channel Intensity

Press the intensity control [▲] or [▼] button to control the intensity output. Slowly press
the intensity button control until you reach the setting recommended by your physician

or therapist. Repeat for the other channel, if both channels are to be used.

Caution:

1) If the stimulation levels are uncomfortable or become uncomfortable, reduce
the stimulation intensity to a comfortable level and contact your medical
practitioner if problems persist.

2) In TENS, EMS and IF therapeutic mode, if the electrodes are not placed firmly
on skin or the device has not been connected to the electrodes, when the output
intensity is set to more than 12mA, the intensity will automatically reset to zero.

4.9 Safety Lock Feature

The Safety Lock Feature automatically activates after there is no operation in the panel
for 30 seconds by locking out the ability to press the buttons. This is a safety feature to
prevent accidental changes to your settings and to prevent accidental increases to the
intensity levels. To unlock the panel, press either one of the [▼] buttons.

4.10 Stop the treatment
When you have activated the treatment timer, you can press the [M] button or the [▼]
button to stop the treatment.

Caution:
If the control panel is locked, you must press one of the [▼] buttons to unlock,
and then press the [M] button or the [▼] button to stop the treatment.

4.11 Turn OFF

Press [ ] button and hold for approx 3 seconds to turn OFF the device.

29

Note:

1) If there is no operation in the panel for 3 minutes in the waiting state, the
device will be turned off automatically.

2) In shutdown state, hold down the Channel 2 [▼] first and then press [ ] at the
same time to restore factory parameter settings.

4.12 Low Battery Indicator

When the low power indicator flashes, the device will be turned off automatically. The
battery should be replaced with a new one as soon as possible. However, the unit may
continue lo operate for a few more hours depends on the setting intensity level
.

5. PROGRAM

Mode

Program

Modulation
Method

Frequency

Pulse
Width

Treat time

TENS

B

Burst

05-5Hz

50-300 uS

1-60 min, cont

N

Continuous

1-150Hz

50-300uS

1-60 min, cont

M

Pulse width
modulation

1-150Hz

50-300us

1-60 min, cont

M1

Frequency
modulation

1-150Hz

50-300us

1-60 min, cont

EMS
S

Synchronous
mode

1-150Hz

50-300us

1-60 min, cont

A

Asynchronous
mode

I – I50 Hz

50-300us

1-60 min, cont

D

Delay mode

1-1 50Hz

50-300us

1-60 min, cont

IF

P1

Frequency
modulation

4kHz
4001 -4010Hz

I 25uS

1-60 min, cont

P2

Frequency
modulation

4kHz
4001--5150Hz

I 25uS

1-60 min, cont

P3

Frequency
modulation

4kHz
4080- 4150Hz

I 25uS

1-60 min, cont

P4

Frequency
modulation

4kHz
4001 -4150Hz

I 25uS

1-60 min, cont

MIC
P1

Continuous

1-150Hz

2-200mS

1-60 min, cont

P2

Frequency
modulation

1-150Hz

2-200 mS

1-60 min, cont

P3

Frequency
modulation

1-150Hz

2-200 mS

1-60 min, cont

30

6. CLEANING AND CARE

6.1 Tips for skin care

To avoid skin irritation, especially if you have sensitive skin, follow these suggestions:
I) Wash the area of skin where you will be placing the electrodes, using mild soap and

water before applying electrodes and after taking them oft. Be sure to rinse soap off
thoroughly and dry skin well.

2) Excess hair may he clipped with scissors; do not shave stimulation area.

3) Wipe the area with the skin preparation your clinician has recommended. Let this dry.
Apply electrodes as directed.

4) Many skin problems arise from the “puling stress’ from adhesive patches that are
excessively stretched across the skin during application. To prevent this, apply
electrodes from centre outward; avoid stretching over the skin.

5) To minimize “pulling stress”, tape extra lengths of lead wires to the skin in a loop to
prevent tugging on electrodes,

6) When removing electrodes, always remove by pulling in the direction of hair growth.

7) It may be helpful to rub skin lotion on eleclrode placement area when not wearing
electrodes.

8) Never apply electrodes over irritated or broken skin.

6.2 Cleaning the device

1) Remove the battery from the device every time you clean it.

2) Clean the device after use with a soft, slightly moistened cloth. In case of more
extreme soiling you can also moisten the cloth with mild soapy water.

3) Do not use any chemical cleaners or abrasive agents for cleaning.

31

6.3 electrodes

Reusable.Selt-adherina Electrodes

To use these electrodes:

l) Attach the electrode to the lead wire.

2) Remove the protective backing from the electrode surface. Do not throw away the
protective backing because it is reused after the treatment session has been completed.

3) Place the tacky surface to the prescribed skin area by pressing the electrode firmly
against the skin.

To removeyour electrodes
I) Lift the corner of the electrode and gently remove it from the skin.

2) Apply the protective backing to the tacky side of the electrode.

3) Place the electrode on the side of the protective backing that is labeled with the word
on.

4) Store the electrodes in the resealable pouch or a plastic bag.

Caution:

1) Do not pull on the electrode wire. Doing so may damage the wire and electrode.

2) Do not apply to broken skin.

3) The electrodes should be discarded when they are no longer adhering.

4) The electrodes are intended for single patient use only.

5) If irritation occurs, discontinue use and consult your clinician.

6) Read the instructions for use of self-adhesive electrodes before application.

7) Always use electrodes which meet CE requirements: IEC/EN60601-1, IS010993­1-5-10 and lEC/EN6O601-1-2, or are legally marketed in the US under 510(K)
procedure.

Connector for inserting
Lead Wire pin

Adhesive pad

32

6.4 Cleaning the patient Lead Wires
Clean the lead wires by wiping them with a damp cloth. Coating them lightly with talcum
powder will reduce tangles and prolong the life.

6.5 Maintenance
I) Maintenance and all repairs should only be carried out by an authorized agency. The
manufacturer will not be held responsible for the results of maintenance or repairs by
unauthorized persons.

2) The user must not attempt any repairs to the device or any of its accessories. Please
contact the retailer for repair.
3 Opening of the equipment by unauthorized agencies is not allowed and will terminate
any claim to warranty.

4) Check the unit before each use for signs of wear and / or damage. Replace worn
items as required.

33

7. TROUBLESHOOTING
If your device does not seem to be operating correctly, refer to the chart below to
determine what may be wrong. Should none of these measures correct the problem, the
device should be serviced.

Problem

Possible Cause

Solution

Display fails to
light up

Battery contact failure

1 Try fresh batteries.
2 Ensure batteries are inserted correctly.
Check the following:
Contacts:

-All contacts are in place -

• All contacts are not broken.

Stimulation weak

Electrodes

1. Dried out or
damaged

2. Incorrect
placement

Lead wires

1. Worn or damaged

Replace and re-connect

Replace

Stimulation is
uncomfortable.

Intensity is too high
Electrodes are too close
together

Damaged or worn
electrodes or lead wires

Electrode active area
size is too small

Decrease intensity.
Reposition the electrodes.

Replace
Replace electrodes with ones

that have an active area no less than
16cm2 (4cm*4cm).

Intermittent
output

Lead wires

Intended feature of
program in use

1. Verify connection is secure. Insert
firmly.

2. Turn down the intensity. Rotate
lead wires in socket 90 degrees.
If still intermittent replace lead
wire.

3. If still intermittent after replacing
lead wire, a component may have
failed- Call the repair department

Some programs will seem intermittent.
This is expected-Refer to the Program
Option controls in the Operation
section for a description of the program
option.

Stimulation is
ineffective.

Improper electrode and
applicator placement
Unknown

Reposition electrode and applicator
Contact clinician

34

8. STORAGE
I) For a prolonged pause in treatment, store the device in a dry room and protect it
against heat, sunshine and moisture.

2) Store the device in a cool, well-ventilated place

3) Never place any heavy objects on the device.

9. DISPOSAL
Used, fully discharged, batteries must be disposed of in a specially labeled collection
container, at toxic waste collection points or through an electrical retailer. You are under
legal obligation to dispose of batteries correctly.
Please dispose of the device in accordance with the legal obligation.

35

10. ELECTROMAGNETIC COMPATIBILITY (EMC) TABLES

Guidance and manufacturers declaration - electromagnetic emissions

The device is intended for use in the electromagnetic environment specified below. The
customer or the user should assure that it is used in such an environment

Emissions testl

Compliance

Electromagnetic environment- guidance

RF emissions
CISPR11

Group 1

The device 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

RFemissions
CISPR11

Class B

The device 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.

Harmonic
emissions
IEC 61000-3-2

Not applicable

Voltage
fluctuations/
flicker emissions
IEC 61000-3-3

Not applicable
Guidance and manufacturers declaration — electromagnetic immunity

The device is intended for use in the electromagnetic environment specified below. The
customer or the user should assure that it is used in such an environment

Immunity
lent

IEC 60601
Test level

Compliance
level

Electromagnetic
environment:-guidance

Electrostatic
discharge
(ESD)
IEC
61000-4-2

+- 6kV contact
+- 8 kV air

+- 6kV contact
+- 8 kV air

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

36

Guidance and manufacturers declaration. Electromagnetic immunity

The device is intended for use in the electromagnetic environment specified below. The
customer or the user should assure that it is used in such an environment

Immunity
test

lEC 60501
Test level

Compliance level

Electromagnetic environment­guidance

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

Conducted
RF IEC
61000-4-6

3 Vrms
150kHz to
80MHz

3 Vrms

d= 1.2P

Radiated
RF IEC
61000-4-3

3Vrms
80 MHz to

2.5gHz

d= 1.2P 80MHz to 800MHz
d= 2.3P 800MHz t0 2.5GHz

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 fixed RF transmitters,
as determined by an
electromagnetic survey should be
less than the compliance level in
each frequency range. Interference
may occur in the vicinity
of equipment marked
with the following symbol

NOTE I At 80MHz ends 800 MHz, the higher frequency range applies.
N OTE2 These guidelines may not apply in all situations. Electromagnetic propagation
is affected by absorption and reflection from structures, objects and people.

1. Field strengths from fixed 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 fixed RF transmitters, and
electromagnetic site survey should be considered. If the measured field strength in
the location in which the device is used exceeds the applicable RF compliance level
above, the device should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as re­orienting or relocating the device.

2. Over the frequency range 150kHz to 80MHz, field strengths should be less than [v]
V/m

37

Recommended separation distances between portable and mobile RF communications
equipment and the device

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

Rated maximum output power of
transmitter W

Separation distance according to frequency of
transmitter m

150 kHz to
80MHz
d=1.2P

80MHz to
800MHz
d=1.2P

800 MHz to

2.5GHz

d=2.3P

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 in meters (m), scan be estimated 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.

NOTE1 : At 80MHz 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 reflection from structures, objects and people.

38

11. NORMALIZED SYMBOLS

12. WARRANTY

Please contact your dealer or the device centre in case of a claim under the warranty. If
you have to send in the unit, enclose a copy of your receipt and state what the defect is.

The following warranty terms apply:

1) The warranty period for the device is one year from date of purchase. In case of a
warranty claim, the date of purchase has to be proven by means of the sales receipt or
invoice.

2) Repairs under warranty do not extend the warranty period either for the device or for
the replacement parts.

3) The following is excluded under the warranty:
 All damage which has arisen due to improper treatment, e.g. nonobservance of

the user instruction.

 All damage which is due to repairs or tampering by the customer or unauthorised

third parties.

 Damage which has arisen during transport from the manufacturer to the

customer or during transport to the service centre.

 Accessories, which are subject to normal wear and tear.

4) Liability for direct or indirect consequential losses caused by the unit is excluded

even if the damage to the unit is accepted as a warranty claim.

Batch code…100601

Serial number …0100001

Attention. Read the operating instructions

Electrical devices are recyclable material and should not be disposed of
with household waste after their useful life. Help us to protect the
environment and save resources and take this device to the appropriate
collection points. Please contact the organization which is responsible for
waste disposal in your area if you have any questions.

Medical Device standard definition:Type BF Applied Part

39

40

Made for TensCare Ltd
9 Blenheim Road
Epsom
Surrey KT19 9BE, UK
[phone]
www.tenscare.co.uk
[e-mail]

Manufacturer:
Name:Shenzhen Dongdixln Technology Co.,LTD.
Add:,XiliBaimang Xushang industrial estate No.3 Bldg
Nanshan dlstrlct Shenzhen,CHINA 518108
Tel:[phone]
Fax:[phone]

Pub no I-MT9000-UK
Revision 2
Feb 2013