Therapeutix sm9128 Product Manual

Before operation, please read this user’s manual carefully, and be clear
about the instructions!

Contents:

Page

I.Foreword …………………………………………………………3
II.User manual …………………………………………………… 4

1. Warnings …………………………………………………………4

2. Precautions ………………………………………………………4

3. Contraindication …………………………………………………6

4. Adverse Reactions …………………………………………………6

5. Indications for Use ………………………………………………7

6. Description of the Device …………………………………………7

6.1 General Description of the Device …………………………7

6.2 Specifications and Essential performance …………………8

6.3 Features ………………………………………………………9

6.4 Mode Description …………………………………………9

7. Direction for Use ………………………………………………13

7.1 General Operation Guidance ………………………………13

7.2 Electrode Guidelines ………………………………… …14

7.3 Regular TENS Application Principles ……………………15

7.4 Regular TENS Application Methods ………………………16

7.5 Regular PMS Application Principles ……………………18

7.6 Regular PMS Application Methods ………………………18

8. Battery …………………………………………………………20

9. Readjustments, alterations and repairs …………………………21

10. Cleaning and maintenance ………………………………… 21

11. Storage…………………………………………………………22

12. Technical checks ………………………………………………22

13. Troubleshooting ………………………………………………24

14. Disposal of the Unit …………………………………………25

15. Warranty period ………………………………………………25

16. Electromagnetic Compatibility ………………………………25

17. Date……………………………………………………………30
III.Labels on the device ……………………………………………31

I. Foreword

Before operation, please read this user’s manual carefully, and be clear about the
instructions.

Two key points for operations:

1) Locate the exact location of the pain: Apply the pads (electrodes) to the muscle area
where you are experiencing pain, stiffness or soreness.

2) Intensity: The intensity should be gradually increased until you reach the highest
setting before it becomes uncomfortable.

Structure and Accessories:

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Accessories =>

Self-adhesive electrodes [510(k) cleared]

Battery charger

800mm (30.5 “) lo ng USB cable

1500m m (59”) lon g Electrode cable

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Included in this package:

* 1 controller * 2 pairs of electrodes [510(k) cleared]
* 2 output electrode cables * 1 USB cable
* 1 charger * 1 User’s manual
* 1 plastic holder

II. User manual

1. Warnings

1) The long-term effects of chronic electrical stimulation are unknown.

2) Do not use stimulation over the main arteries around your neck.

3) Do not use stimulation over the neck or mouth. Severe spasm of muscles may
occur and the contractions may be strong enough to close the airway or cause
difficulty in breathing.

4) Do not apply stimulation directly to the heart area across the chest or on the chest.

5) Do not use stimulation on your head or across your head.

6) Do not use stimulation over swollen, infected, or inflamed areas or skin eruptions,
e.g., phlebitis, thrombophlebitis,varicose veins.

7) Do not use stimulation over, or in proximity to, cancerous lesions.

8) Do not use stimulation when charging the device.

2. Precautions

1) Do not use the muscle stimulator during pregnancy.

2) Do not use if you have heart problems.

3) Do not use if you have epilepsy.

4) Do not use the device in the presence of the following:
a. When there is a tendency to hemorrhage following acute trauma or fracture;
b. Following recent surgical procedures when muscle contraction may disrupt the
healing process;
c. Over the menstruating or pregnant uterus;
d. Over areas of the skin which lack normal sensation.

5) Do not use the products near the heart, it may cause fast or irregular heartbeat.

6) Some patients may experience skin irritation or hypersensitivity due to the
electrical stimulation or electrical conductive medium. The irritation can usually be
reduced by using an alternate conductive medium (like gel), or alternate electrode
placement.

7) Therapeutix TENS&PMS must be kept out of the reach of children.

8) Therapeutix TENS&PMS should be used only with the leads and electrodes
recommended for use by the manufacturer.

9) Never apply the pads to your skin with the power on, which will result in sudden
shock. If, during application, you want to move the pads to another body part, please
shut down the device first, and then move the pads to the place that you want to
stimulate.

10) Never use this product near the following devices: pacemakers or any other
embedded electronic medical devices, heart-lung machine and any other life keeping
electronic medical devices, electrocardiograph and any other medical screening and
monitoring devices. Simultaneous use of the Therapeutix TENS&PMS and any of the
above devices will cause malfunction and can be very dangerous to the users.

11) Two pads should be used together as a pair. Always peel off the protective film on
the pads before use. To avoid an electrical short, do not connect two pads to each
other.

12) Do not apply pads to the same spot for over 60 minutes at a time.

13) Do not use the Therapeutix TENS&PMS while driving, operating machinery, or
during any activity in which involuntary muscle contractions may put the user at
undue risk of injury.

14) Do not use the product in bathroom or a moist environment. Do not use while
bathing.

15) Do not use the product in the condition of air mixed with flammable gases.

16) Never use this product in concurrence with high frequency surgical equipment; it
may result in burns at the site of the stimulator electrodes and possible damage to the
control unit.

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17) Never use this product near a microwave oven, or other high frequency
equipment.

18) Never use this product while it is being charged.

19) Do not operate the product in close proximity (e.g. 1m/3ft)) to shortwave
therapy equipment, it may produce instability in stimulator output.

3. Contraindication

1) Do not use this device on patients who have a cardiac pacemaker, implanted
defibrillator, or other implanted metallic or electronic device, because this may
cause electric shock, burns, electrical interference, or death.

2) Do not use this device on patients whose pain syndromes are undiagnosed.

3) Do not use this device during pregnancy.

4) Do not use this device on babies or infants who cannot express themselves.

4. Adverse Reactions

1) Patients may experience skin irritation and burns beneath the stimulation
electrodes applied to the skin;

2) Patients may experience headache and other painful sensations during or
following the application of electrical stimulation.

3) Patients should stop using the device and should consult with their physicians if
they experience adverse reactions from the device.

5. Indications for Use
TENS:

To be used for temporary relief of pain associated with sore and aching muscles in
the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg)
due to strain from exercise or normal household work activities. Choose Mode 1, 3,
4, 5, 6.

PMS:

It is intended to be used to stimulate healthy muscles in order to improve and

facilitate muscle performance. Choose Mode 1, 2, 3, 6.

6. Description of the Device

6.1 General Description of the Device

Therapeutix TENS & PMS is a portable and DC 3.7V battery powered multifunction
device, offering both Transcutaneous Electrical Nerve Stimulation (TENS) and
Powered Muscle Stimulation (PMS) qualities in one device.
Therapeutix TENS & PMS has 6 operation modes, which can give certain electrical
pulses through electrode adhesive pads to the suggested area of the body where the
electrodes are placed.
The electronic stimulatory module has the operating elements of an ON/OFF Switch,
Display screen, Mode Selection key, Intensity Modification keys, Timing key, Pause
key, Output socket, and USB port for battery charging.
The display screen can show battery power, selected mode, current intensity, time
remaining of an application mode, and indication of a pause (Page 10, No. 10).
The device is equipped with accessories of electrode pads, electrode cables, a battery
charger, and one USB cable. The electrode cables are used to connect the pads to the
device; the USB cable is used to connect the charger and the built-in lithium battery.
All accessories, including USB cables, electrode pads, electrode cables, chargers can
only be changed or replaced by a qualified person.
The electrodes are interchangeable. The application area of electrode pads must be
larger than the smaller electrode pads. The electrode pads are provided by GMDASZ
Manufacturing Co., Ltd. with 510(k) cleared Number K092546.

6.2 Specifications and Essential performance:

(Essential performance: The values of pulse duration, amplitudes, and repetition
frequencies do not deviate by more than ±30% when measured with an error not
exceeding ±10% into a load resistance (500Ω) within the range specified by the
manufacturer.)

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- Power supply: DC 3.7V

- Output voltage: 42V@500Ω

- Output current: 84mA@500Ω

- Consumed current: 40mA

- Pulse width: 100μS

- Frequency: 1~110Hz

- Smallest are of electrode pad: 4cm2

- Timer: 10~60 minutes

- Strength level adjustment: 20 grades

- Charger: Input: 100-240V 50/60Hz 0.18A Max; Output: DC5V 250mA; Class
II, not applied part, not suitable for use in the presence of a flammable gases,
with oxygen or nitrous oxide, or for continuous operation..

6.3 Features

* A large, easy to read LCD display
* Adjustable timer
* 6 Modes
* Rechargeable lithium battery

6.4 Mode Description

We suggested that you initially experiment using each of the 6 modes. The mode that
gives you the most desirable sensations and comfort is the most appropriate one to use
for your current condition.

1) Intensity should be set at a level where you will feel some muscular vibration and
involuntary muscle movements.
It should be set to give a comfortable feeling and should not be painful.

2) Timing of application should be at least 10 to 20 minutes.

3) Frequency of the application should be at least one to three times per day.

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Mode 3 1) Timing: 10~60 minutes

2) Pulse train frequency:

1.17Hz

3) Pulse width: 100μS

4) On time: 0.7ms

5) Off time: 849.3ms

6) Duty cycle: 850ms

The device outputs 2 groups of symmetrical pulse at intervals of 0.85 seconds. The
pulse width is 100μS fixed.

Mode 4 1) Timing: 10~60 minutes

2) Pulse train frequency:

5.813Hz

3) Pulse width: 100μS

4) On time: 3.02s

5) Off time: 1.1s

6) Duty cycle: 4.12s

The device outputs 2 groups of symmetrical pulse at intervals of 0.172s.
The pulse width is 100μS fixed. The whole waveform works for 3.02s and stops for

1.1s. The device repeats this cycle all the time.

Modes

Parameters

Graphical Description

Mode 1

1) Timing: 10~60 minutes

2) Frequency: 68Hz

3) Pulse width: 100μ S

4) On time: 3s

5) Off time: 1.56s

6) Duty cycle: 4.56s

The amplitude for the wh ole pulse takes 2.64 seconds from zero to maximum and
stays on for 0.36 seconds; then the device stops for 1.56 seconds. The device repeats
this cycle all the time. The output frequency is 68Hz and the pulse width is 100μS.

Mode 2

1) Timing: 10~60 minutes

2) Frequency: 12.5~55.5Hz

3) Pulse width: 100μ S

4) On time: 20.S

5) Off time: 1s

6) Duty cycle: 21s

The output amplitude and pulse widt h (100μS) are fix ed; the frequenc y changes
among 12.5Hz to 55.5Hz; and there are 64 periods (on 220ms, off 100ms), then the
device stops for 1 second. The device repeats this cycle all the time.

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7. Direction for Use

7.1 General Operation Guidance

1) The Therapeutix TENS & PMS unit needs to be charged for up to 10 hours before
the first use.

2) Connect the electrode cables to the output sockets at the bottom of the unit.

3) Connect the pads to the cables by snapping them on.

4) Use a damp towel to wipe the skin where you intend to put the pads, so as to
remove any body oil, cosmetic or dirt. Remove the protective film and place the pads
on the area making sure that both pads are on the skin and not overlapping.
Warning: To avoid an electrical short, never put two electrode pads together.

5) Turn on the unit by sliding the On/Off switch from Off to On.
Warning: Do not move pads or touch them with your hands during use, it may cause
strong stimulation.

6) When you have turned on the unit, the LCD display will automatically show Mode

1. The “T” (Timer) will automatically choose the time duration of 20 minutes.

7) To change the modes, press the M (Mode) button. Once you have selected a mode,
gradually increase the intensity by pressing the + button, and to decrease the intensity
by pressing the – button. The chosen power output depends on your comfort level. At
the precondition of acceptance, the intensity should be chosen as high as possible for
the best effect but still feel comfortable.

8) To set the time of use, press the T button. The auto time set is 20 minutes. Each
press of the T button increases the time by 10 minutes. After the time runs out the
device turns off automatically, and it can be restarted if treatment is needed to be
continued.

9) Sit back and enjoy the deep soothing sensations!
Notes: The Therapeutix TENS & PMS unit is very safe, the output intensity increases
only by pushing the + key. Even if the intensity is increased to the maximum, it is
within the safe range, but may feel uncomfortable. When the user switches the mode,
the intensity will automatically go down to the minimum for safety reasons.

10) Press the Pause key (“►II” button) to lock the LCD display, the “MODE” display

Mode 5

1) Timing: 10~60 minutes

2) Frequency: 108.2 Hz

3) Pulse width : 100μS

4) On time: 3.03s

5) Off time: 1.3s

6) Duty cycle: 4.33s

The output frequency (108Hz), amplitude and pulse width (100μS) are fixed, on for

3.03 seconds and off for 1.3seconds. The device repeats this cycle all the time.

Mode 6

1) Timing: 10~60 minutes

2) Frequency: 59Hz

3) Pulse width : 100μS

4) Build-up ph ase: 0.52s

5) Working time: 0.84s

6) Run-down phase: 0.52s

7) Pause phas e: 1s

8) Duty cycle: 10.4s

The output frequency (59Hz) and pulse width (100μS) do not change; the amplitude
for the whole pulse takes 0.52s from zero to m aximum and st ays for 0.84s; then it
takes 0.52s from maximum to a half.
Then the device repeats 3 times of the following: the amplitude for th e whole pulse
takes 0.52s from a half to maximum and lasts for 0.84s; then it takes 0. 52s from
maximum to a half.
Then the amplitud e fo r th e who le pulse takes 0.52s from a half to maxim um and
lasts for 0.84s; then it takes 0.52s from maximum to 0, and stops for 1s.
The device repeats the above cycle all the time.

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will blink.The device will not work no matter what key you press on the control
panel,it is locked.To unlock press the Pause key again.

11) If you need to turn off the device during stimulation, slide the On/Off switch to

“OFF”.

12) Before storing the TENS & PMS use the protective film to cover the electrode
pads.
Notes:

① Never connects this product with a common headphone.
② Please do not touch the USB port when using the device. The USB port is only

used to connect the charger, do not connect other devices.
③ The charger supplied by the manufacturer must in compliance with IEC/EN
60601-1, the use of unauthorized chargers can impair the safety.
④ The battery needs to be charged for up to 10 hours before the first use.

7.2 Electrode guidelines

1) Use only the electrodes supplied by the manufacturer; other electrodes may
present a risk of unsuitable electrical characteristics with your stimulator.

2) Do not use the electrodes on different people, otherwise, skin reaction or cross
contamination may occur.

3) Always turn power off before removing or repositioning the electrodes.

4) Wash skin thoroughly, and then dry it before applying the electrodes.

5) Apply the whole surface of the electrodes firmly to the skin. Do not use electrodes
that do not stick properly to the skin or only partially stick to the skin.

6) In case of skin redness under the electrodes after a stimulation session, do not start
a new session in the same place if skin redness is still evident.

7.3 Regular TENS Application principles

1) Find the exact pain point or the area where the muscles ache most. For best
relief of pain, place the electrode pair from one channel on either side of the pain.
(See Figure 1: Twin mode) or you may place one electrode on the painful site and

the other near the site of pain.

2) Intensity: The intensity can be gradually increased up to the point when it
becomes uncomfortable. Always stay below that point of discomfort.

3) Recommended application duration and Mode selection:

When starting out, choose Mode 1 at a low Intensity level for 10 minutes up

to 3 times a day. You may increase the intensity and time after you have
become familiar with the device and the feel for the stimulation. Stay with
Mode 1 for a few days before trying any of the other Modes and intensity
settings. Remember, the modes to be used for pain relief are Modes 1, 2,3, 4, 5
and 6.

It is difficult to recommend a particular mode for a specific type of pain and it

is usually determined by the user’s feel of relief.

However, if you do not feel any relief of pain after having tried different

modes and intensities it is recommended that you consult with your physician.

4) If the stimulation sensation becomes weaker or disappears, you may increase
the intensity by pressing the up key (+) to a point when the stimulation becomes
uncomfortable, but if the sensation does become uncomfortable, press the down
key (-) to decrease the intensity. Always stay under the point of discomfort!

5) If you experience an adverse reaction (skin irritation/redness/burns /other
painful sensation), or if you feel unusual discomfort, stop using the device
immediately.

6) There are two ways to place the pads, in twin or opposed modes.

Fix the two pads from one channel on either side of the pain area, or one
electrode on the painful site and the other near the site of pain, but on the same
side of body. If you want to use both channels at the same time, make sure that
the second pair of electrodes is also fixed near the side of pain on the same side
of the body (right under or over the first pair)

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Figure 1: Twin mode (this is the correct mode)

Fixing the two or four pads respectively on the opposite sides of the
body is not recommended and provides little benefit.

Figure 2: Opposed mode (Not recommended)

7.4 Regular TENS Application Methods

Use the device for temporary relief of pain associated with sore and aching muscles
in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities
(leg) due to strain from exercise or normal household work activities.
Users can choose Mode 1, 2, 3, 4, 5 or 6 for temporary relief of pain.
* Many people experience immediate relief from muscle pain, while others require
several days of regular use to feel the benefits. The results vary and will depend
upon your underlying conditions and how often you use the device.
If your pain does not improve, you can try to increase the intensity and time or
change the mode.

Note:
The charts below are merely a suggestion for where to place the electrodes, what
Mode to choose and how long to stimulate, but only after the user has gone
through the starting procedure (above) and is familiar with the device.

● Pain in Neck

Figure 3:

Mode 1 (A) for 10-20 minutes, and Mode 3 for 10-20
minutes; twice or 3 times a day.
* Keep the neck warm and avoid sleeping on a high
pillow.

● Pain in shoulders

Mode 4 (B & C) for 10-20 minutes, and Mode 5 for
10-20 minutes; twice or 3 times a day.
* Find the pain area and apply the electrodes at the
anterior and posterior (inner & outer) shoulders.
* Keep the area warm. Avoid sudden movements with
the aching shoulders, gentle movements are advisable
in the initial stage and full motions at a later stage.

● Pain in Back

Mode 1 for 10-20 minutes, and Mode 5 or 6 for 10-20
minutes; twice or 3 times a day.
* Apply the electrodes to the pain area.
* Avoid working in the same position in the initial
phase and change the position at times.

● Pain in Waist

Figure 4:

Mode 3 or 6 to stimulate (A) for 10-20 minutes,
Mode 1 to stimulate (B and C) for 10-20 minutes;
twice or 3 times a day.

● Pain in Joints and limbs

Figure 5:

Mode 1 for 10-20 minutes, and Mode 4 for 10-20
minutes; twice or 3 times a day.

Figure 6:

Mode 3 for 10-20 minutes, and Mode 4 for 10-20
minutes; twice or 3 times a day.

Figure 7:

Mode 1 for 20 minutes and Mode 3 for 20 minutes;
twice or 3 times a day.

Figure 8:

Mode 4 for 10-20 minutes, and Mode 6 for 10-20
minutes; twice or 3 times a day.
* Do not use this device directly on the pain area or
area of injury.

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7.5 Regular PMS Application principles

1) Identify the targeted muscle which needs to be stimulated. In order to improve
or facilitate muscle performance, place the two electrodes from one channel on
opposite ends of the muscle or close to the belly of the muscle. (See Figure 9)
If you like to work with both channels at the same time you may place the second
electrode pair near the first pair or onto another muscle to be stimulated like the
biceps on the opposite arm in Fig 9 below.

2) Intensity: The intensity can be gradually increased up to the point when it
becomes uncomfortable. Always stay below that point of discomfort.

3) Recommended application duration and Mode selection:
The modes to be used for improving the muscle performance are Modes 1, 2, 3
and 6.
Mode 1: exercise preparation
Mode 2: Build endurance
Mode 6: muscle strengthening
Mode 3: Active recovery

7.6 Regular PMS Application Methods

This function is intended to stimulate healthy muscles including abdomen
muscles in order to improve or facilitate muscle performance.
You can use the electrode adhesive pads on almost every muscle and joint area on

your body. Please note that this device is intended to stimulate healthy muscles
in order to improve or facilitate muscle performance. It is not intended as
therapy for any medical condition.
Users can choose Mode 1, 2, 3 or 6 to stimulate the following points to quickly
facilitate muscle performance. In order to better improve the muscle
performance, you may increase the intensity gradually to a level which is still
comfortable and does not cause pain or discomfort. Furthermore, you should
use the Therapeutix TENS & PMS regularly to maintain the benefit you may
have gained during exercise.

Note:
The charts below are merely a suggestion for how to place the electrodes,
what Mode to choose and how long to stimulate, only after the user has gone
through the starting procedure (above) and is familiar with the device.

Targeted

muscle

Figure 9:

● Abdomen

Mode 1 for 10-20 minutes, Mode 2 for 10-20
minutes, and Mode 6 for 10-20 minutes; twice or
3 times a day.
* Persistent and consistent use can help to
improve the abdomen muscles.

● Waist

Mode 1 for 10-20 minutes, Mode 3 for 10-20
minutes, and Mode 6 for 10-20 minutes; twice or
3 times a day.
The device exercises the muscles in the waist
* It is advisable to do some waist exercise after
the application.

● Shoulders and Back

Mode 1 for 10-20 minutes, and Mode 2 or 3 for
10-20 minutes; twice or 3 times a day.
Apply the electrodes to the points shown to
exercise these shoulder muscles

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● Buttocks

Mode 1 for 10-20 minutes, and Mode 6 for 10­20 minutes; twice or 3 times a day.
Apply the device to the points shown to exercise
the muscles.

● Legs

Mode 1 for 10-20 minutes, Mode 2 for 10-20
minutes, and Mode 3 for 10-20 minutes; twice or
3 times a day.
The device can stimulate areas of the legs and
thighs so as to improve the muscles.

8. Battery

8.1 Battery information

Capacity: 110mAh
Voltage: DC 3.7V
Restriction: 4.2V

8.2 Charging the Battery

1) The Lithium battery can be recharged through both AC adaptor and computer
USB input.

2) Turn off the unit.

3) Connect the unit and the charger with USB extension cord. Plug charger into
any power outlet, a green light shows that it is charging. The charging process
will last approximately 1 hour. When charging is finished, the LCD will show a
full battery cell.

4) The battery should be charged for 10 hours or so before first use. We have

done this for you!

Notes: Only charge the unit when battery is completely drained the first 2
times. Unplug the charger from power outlet when charging is complete. When
stimulation intensity decreases, it indicates that the device needs charging.
Recharge it and then continue to use the device. Do not use the device while
charging.

9. Readjustments, alterations and repairs

1) Do not disassemble, repair or modify the device without authorization, you
will void any warranty on the product.

2) The manufacturer is only responsible for the safety and performance of
Therapeutix TENS & PMS when readjustments, alterations and repairs are
carried out by authorized individuals and when the Therapeutix TENS & PMS
is used in accordance with the user instructions.

3) Qualified technicians who are familiar with the technical features of the
device have been provided with circuit diagrams, PCB drawings, component
lists and setting instructions by the manufacturer.

10. Cleaning and maintenance

A. For the control unit:

1) To keep the controller clean, use a soft and dry cloth for dust or a soft damp
cloth for any dirt and smudges. Do not use any cleaning solutions to clean the
controller and its pads.

2) Do not use or store the device where there are magnetic fields or electric
waves (near TV set or speakers).

3) Do not place the devices in areas of high temperature, high humidity, or
under direct sunlight.

4) Keep the device out of reach of children.

5) All worn accessories should be disposed of according to your local
regulations.

B. For electrode pads:

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* Refer to the user manual of the pads manufacturer (510K092546), or
reference to the following suggestions:

1) Unplug the output cord from the output jack of the controller after each
use. Cover both pads with the protective film before storage. Never fold the
electrode pads.

2) Between uses, store the electrodes in the reusable bag in a shady place.
Stockroom temperature: +5°C~+27°C (41-80°F) and humidity of 30%~80%.
No need to sterilize.

3) Never apply the pads to any other surface other than your skin. If the pads
become soiled or dirty, the adhesive power may decrease. In this case,
moisten the surface of the pads with water and wipe away the dirty portion.
This will allow a temporary restoration of the adhesive power. However, too
much water will result in loss of the adhesive power.

4) The life of the electrodes varies depending on skin conditions, storage,
amount of use, type of stimulation, and stimulation site. Electrode life may be
extended by carefully following this Instruction for Use. The expired
electrodes are to be recycled and do not harm environment.

Warning: The electrodes are intended for single patient use only!

11. Storage

Caution: Do not store in a damp area. Dampness may affect the device and
cause rust.

- Normal working ambient temperature: 5°C~40°C (40-104°F)

- Normal working ambient humidity: ≤80%RH

- Store and transport ambient temperature: -20°C~55°C (4° -131° F)

- Store and transport ambient humidity: ≤93%RH

12. Technical checks

Technical checks on the device should be performed every 24 months.
These include:

1. Checking to see whether the user instructions and the medical device book are
included in the accompanying documentation.

2. Checking the equipment for completeness.

3. Visual check:

- for mechanical damage

- for damage to all cables and connections

4. Functional safety

- Checking the output signals with a load resistance of 500Ω real (current and
voltage)

- Checking the frequency

- Checking the pulse width.
These technical checks may only be performed by individuals with appropriate
training. The results must be noted in the medical device book along with the date
and name of the person carrying out the check.

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13. Troubleshooting

14. Disposal of the Unit

To dispose of the unit, its accessories and packing materials, take appropriate
actions in accordance with the rules and regulations in force in your area to
prevent adverse ecological effects.

15. Warranty period

We offer a lifetime warranty from the date of purchase on Therapeutix
TENS Unit Electronic Massagers. This warranty does not cover cables and
electrodes.

16. Electromagnetic Compatibility

Important information regarding Electro Magnetic Compatibility (EMC)
With the increased number of electronic devices such as PC and mobile
(cellular) telephones, radio transceivers, mobile radio transmitters,
radio-controlled toys, and so on, Medical devices in use may be susceptible to
electromagnetic interference from other device. Electromagnetic interference
may result in incorrect operation of the medical devices and create a
potentially unsafe situation. Medical devices should also not interfere with
other devices.

In order to regulate the requirements for EMC (Electro Magnetic
Compatibility) with the aim to prevent unsafe product situations, the
EN60601-1-2 standard has been implemented. This standard defines the levels
of immunity to electromagnetic interference as well as maximum levels of
electromagnetic emissions for medical devices.

This unit has been thoroughly tested and inspected to assure proper
performance and operation! This product needs special
precautions regarding EMC and needs to be installed and put into service
according to the EMC information provided,
the following tables recommend minimum separation distances between
portable and mobile RF communications equipment and the TENS unit.

Problems

Possible causes

Try this solution

No.

One pad feels stronger than the
other.

This is normal. Different areas of your
body will react differently.

Nothing needs to be done. Make sure the
pads are sticky and are making good
contact.

1 The intensity is not felt.
Very weak intensity level.

Pads are not attached to the body firmly.

Attach both pads firmly to the skin.

The transparent films are still stuck to
the pads.

Peel off film on the adhesive surface of
pads.

The pads stacked together or overlap.

Do not stack pads together or overlap
pads.

The cord is not properly connected to the
unit.

Connect cord correctly into the jack.
The intensity setting is getting weak.

Increase the intensity level.

The battery capacity is low.

Charge the battery.

2 The skin turns red or the skin
feels irritated.

The adhesive surface of pads is dirty or
dry.

Wash adhesive surface of pads softly
with your fingertips for about 3 seconds
under slow running water.

The therapy time is too long or the
intensity is set too high.

Reduce the application time or reduce
the intensity.

The electrode pad surface is worn out.

Replace electrode pad.

3 No power source; no display in
LCD.

The battery capacity is depleted.

Charge the battery.

4 Power cut off during use.
The battery is weak.

Charge the battery.

The cord is broken.

Replace the cord.

5 It is difficult to attach the pad
to the skin.

Have you removed the transparent film
from the pad?

Peel off film on the adhesive surface of
pads.

Was the pad applied immediately after
washing?

Dry the pad.

Is the adhesive surface of the pad
damaged?

Replace the pad.

6 Adhesive surface of pad is not
sticky.

Are you using pad when perspiring?

Use when not perspiring, in a cool room.

Were the pads stored under high
temperature, high humidity, or direct
sunshine?

Replace the pad.

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Caution:

* The use of accessories and cables other than those specified by Therapeutix,

with the exception of cables sold by Therapeutix as replacement parts for
internal components, may result in increased emission or decreased immunity
of the device.
* Do not use a mobile phone or other devices that emit electromagnetic fields,
near the unit. This may result in incorrect operation of the unit.
* This device should not be used adjacent to or stacked with other equipment
and that if adjacent or stacked use is necessary, this device should be observed
to verify normal operation in the configuration in which it will be used.
* Refer to further guidance below regarding the EMC environment in which
the device should be used.
There is no guarantee that interference will not occur in a particular
installation. Radiated or conducted electromagnetic signals can cause:

1) As to devices:

• Deviation of the values of pulse duration, amplitudes, and repetition
frequencies, may impair the unit’s essential performance. The device has

passed EMC highest interference level test, and the parameters do not deviate
the essential performance requirement.

• The device displays abnormally in LCD.

2) As to patients:

• The sensitivity of stimulation may be weaker or stronger, but it does not
produce safety issues.

• It cannot achieve expected effect.
If this equipment is found to cause or respond to interference, attempt to
correct the problem by one or more of the following measures:

• If feeling too weak or too strong stimulation, adjust the strength level to an
acceptable level.

• If the device display is abnormal, power off and restart the device and check
whether it shows properly.

• Re-orient or re-locate the affected device.

• Increase the separation between the unit and the affected device.

• Power the equipment from a source other than that of the affected device.

• Consult the service representative for further suggestions.

1) Guidance and manufacture’s declaration – electromagnetic emission

The Therapeutix TENS & PMS is intended for use in the electromagnetic
environment specified below. The customer of the user of the Therapeutix
TENS & PMS should assure that it is used in such an environment.

Emission test

Compliance Electromagnetic environment – guidance

RF emissions CISPR 11

Group 1

The Therapeutix TENS & PMS 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.

RF emission CISPR 11

Class B

The Therapeutix TENS & PMS is suitable for use in
all establishments, including domestic establishments
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

Class A

Voltage fluctuations / flicker
emissions IEC 61000-3-3

Complies

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29

2) Guidance and manufacture’s declaration – electromagnetic immunity 3) Guidance and manufacture’s declaration – electromagnetic immunity

The Therapeutix TENS & PMS is intended for use in the electromagnetic environment specified below. The customer or the user of
Therapeutix TENS & PMS should assure that it is used in such an environment.

Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment - guidance

Conducted RF
IEC 61000-4-6

3 V

rms

150 kHz to 80 MHz

3 Vrms

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

Recommended separation distance

d 1.167 P
d 1.167 P 80 MHz to 800 MHz
d 2.333 P 800 MHz to 2.5 GHz

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 site survey,a should be less than the
compliance level in each frequency range.

b

Interference may occur in the vicinity of equipment marked

with the following symbol:

Radiated RF
IEC 61000-4-3

3 V/m

80 MHz-2.5 GHz

3 V/m

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
reflection from structures, objects and people.

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, an electromagnetic site survey should be considered. If the
measured field strength in the location in which the Therapeutix TENS & PMS is used exceeds the applicable RF compliance
level above, the Therapeutix TENS & PMS should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as reorienting or relocating the Therapeutix TENS & PMS. Over the
frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

The Therapeutix TENS & PMS is intended for use in the electromagnetic environment
specified below. The customer or the user of Therapeutix TENS & PMS should assure
that it is used in such an environment.

Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment - guidance

Electrostatic discharge
(ESD)
IEC 61000-4-2

±6 kV contact
±8 kV air

±6 kV contact
±8 kV air

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

Electrical fast
transient/burst
IEC 61000-4-4

±2 kV for power
supply lines

±2kV for power
supply lines

Mains power quality should be that of a typical
commercial or hospital environment.

Surge
IEC 61000-4-5

± 1 kV line(s) to line(s)

±1 kV differential mode

Mains power quality should be that of a typical
commercial or hospital environment.

Voltage dips, short

<5% UT

<5% UT

interruptions and

(>95% dip in UT)

(>95% dip in UT)

voltage variations on
power supply input lines
IEC 61000-4-11

for 0.5 cycle

40% UT
(60% dip in UT)
for 5 cycles

for 0.5 cycle

40% UT
(60% dip in UT)
for 5 cycles

Mains power quality should be that of a typical
commercial or hospital environment. If the user
of the Therapeutix TENS & PMS requires
continued operation during power mains
interruptions, it is recommended that the

70% UT
(30% dip in UT)

70% UT
(30% dip in UT)

Therapeutix TENS & PMS be powered from an
uninterruptible power supply or a battery.

for 25 cycles

for 25 cycles

<5% UT

<5% UT

(>95% dip in UT)

(>95% dip in UT)

for 5 sec

for 5 sec

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

3A/m

3A/m

Power frequency magnetic fields 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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31

4) Recommended separation distances between portable and mobile RF
communications equipment and the Therapeutix TENS & PMS

III. Labels on the device

Notes:

17. Date

Issue date of the manual: 12-25-2014

Production date: 12-30-2014

Batch: xxx-xxx

Therapeutix

Model:SM9128
lnput:DC 3.7V
Weight:38.6g
Size:86x43.2x10.6MM

The Therapeutix TENS & PMS is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
The customer or the user of the Therapeutix TENS & PMS can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment (transmitters) and the Therapeutix TENS & PMS 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 80 MHz

d 1.167 P

80 MHz to 800 MHz

d 1.167 P

800 MHz to 2.5 GHz

d 2.333 P

0.01

0.117

0.117

0.233

0.1

0.369

0.369

0.738

1

1.167

1.167

2.333

10

3.689

3.689

7.379

100

11.667

11.667

23.333

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can
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.

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

reflection from structures, objects and people.

Symbol

Meaning

Class II equipment

Type BF applied part

Operating instructions

Manufacturer