TensCare MT9000 User manual

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Instruction Manual
for the
T.I.M.E. Multitherapist
Model MT9000
www.tenscare.co.uk

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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.

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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, post-
traumatic 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.).

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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.

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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.

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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.

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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
2pieces
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 2pulse 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

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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.

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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

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Synchronous (S)
ON TI ME OFF TIME
Alternate (A)
Delay (D)
Delay time

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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.

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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.