Tens Twin Stim Plus Instruction Manual

FOR THE

INSTRUCTION MANUAL

INSTRUCTION MANUAL

Twin Stim Plus

R

FDA 510K

DIGITAL TENS/EMS

Distributed by:

V1.0

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INDEX

1. General Description .............................................. 2

2. Introduction ........................................................... 2

3. Cautions................................................................. 4

4. Warnings ................................................................ 6

5. Contraindications.................................................. 6

6. Adverse Reactions ................................................ 6

7. Construction.......................................................... 7

8. Technical Specifications ....................................... 9

9. Replaceable Parts ................................................. 13

10 Accessories .......................................................... 13

11. Graphic Symbols ................................................... 14

12. Operating Instructions ......................................... 14

13. Parameter Controls.............................................. 15

14. Attachment of Electrode Lead Wires .................. 18

15. Lead Wire Maintenance ........................................ 18

16. Electrode Options ................................................. 19

17. Electrode Placement............................................. 19

18. Tips for Skin Care ................................................. 20

19. Application of Reusable self

adhesive electrodes ............................................. 20

20. Adjusting the Controls ......................................... 22

21. Battery Information............................................... 30

22. Maintenance, Transportation, and

Storage of the Device ........................................... 31

23. Safety-Technical Controls .................................... 32

24. Malfunctions.......................................................... 32

25. Conformity to Safety Standards .......................... 33

26. Warranty................................................................. 33

Chapter Contents Page

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HOW TENS WORKS

There is nothing “magic” about Transcutaneous Electrical Nerve
Stimulation (TENS). TENS is intended to be used to relieve pain. The
TENS unit sends comfortable impulses through the skin that stimulate
the nerve (or nerves) in the treatment area. In many cases, this
stimulation will greatly reduce or eliminate the pain sensation the
patient feels. Pain relief varies by individual patient, mode selected
for therapy, and the type of pain. In many patients, the reduction or
elimination of pain lasts longer than the actual period of stimulation
(sometimes as much as three to four times longer). In others, pain is
only modified while stimulation actually occurs. You may discuss
this with your physician or therapist.

EXPLANATION OF EMS

Electrical Muscle Stimulation 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, originally invented
by John Faraday in 1831. Through the square wave pattern it is able
to work directly on muscle motor neurons. The Twin Stim® has low
frequency and this in conjunction with the square wave pattern
allows 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 improving muscle tone and blood circulation.

HOW EMS WORKS

1. Relaxation of muscle spasms

2. Prevention or retardation of disuse atrophy

3. Increasing local blood circulation

4. Muscle re-education

5. Immediate post-surgical stimulation of calf muscles to prevent

venous thrombosis

6. Maintaining or increasing range of motion

The EMS units send comfortable impulses through the skin that
stimulate the nerves in the treatment area. When the muscle receives
this signal it contracts as if the brain has sent the signal itself. As the

Chapter 1: GENERAL DESCRIPTION

The Twin Stim® Plus Digital TENS/EMS is a battery operated pulse
generator that sends electrical impulses electrodes to the body and
reach the nerves and underlying muscle group. This unit is a
combination stimulator of TENS and EMS which can be used for
muscle stimulation and pain relief. The device is provided with two
controllable output channels, each independent of each other. An
electrode pair can be connected to each output channel. The intensity
controls are protected by a cap to avoid accidental touch. The settings
are controlled by press buttons.

Chapter 2 : INTRODUCTION

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 is a non-invasive, drug­free 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 most
patients it is effective in reducing or eliminating the pain, allowing for
a return to normal activity.

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8. 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.

9. Turn the TENS off before applying or removing electrodes.

10.Isolated cases of skin irritation may occur at the site of electrode

placement following long term application. If this occurs,
discontinue use and consult your physician.

11. If TENS therapy becomes ineffective or unpleasant, stimulation

should be discontinued until its use is re-evaluated by a physician

12.Keep this device out of the reach of children.

13.The device has no AP/APG protection.

Do not use it in the presence of explosive atmosphere and
flammable mixture.

EMS

1. Federal law (USA) restricts this device to sale by or on the order

of a physician

2. Safety of powered muscle stimulators for use during pregnancy

has not been established.

3. Caution should be used for patients with suspected or diagnosed

heart problems.

4. Caution should be used for patients with suspected or diagnosed

epilepsy.

5. Caution should be used 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; and
d. Over areas of the skin which lack normal sensation.

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, or alternate electrode placement.

7. Electrode placement and stimulation settings should be based on
the guidance of the prescribing practitioner.

8. Powered muscle stimulators should be kept out of the reach of
children.

9. Powered muscle stimulators should be used only with the leads
and electrodes recommended for use by the manufacturer.

signal strength increases, the muscle flexes as in physical exercise.
Then when the pulse ceases, the muscle relaxes and the cycle
starts over again, (Stimulation, Contraction and Relaxation.) Powered
muscle stimulators should only be used under medical supervision
for adjunctive therapy for the treatment of medical diseases and
conditions.

IMPORTANT SAFETY INFORMATION

Read instruction manual before operation. Be sure to comply with all
“CAUTIONS” and “WARNINGS” in the manual. Failure to follow
instructions can cause harm to user or device.

Chapter 3 : CAUTIONS

TENS

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

2. Do not use this device for undiagnosed pain syndromes until
consulting a physician.

3. Patients with an implanted electronic device, such as a cardiac
pacemaker, implanted defibrillator, or any other metallic or electronic
device should not undergo TENS treatment without first consulting
a doctor.

4. Patients with heart disease, epilepsy, cancer or any other health
condition should not undergo TENS treatment without first
consulting a physician.

5. 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.

6. 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.

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

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Chapter 7 : CONSTRUCTION

FRONT

(1)LEAD CONNECTOR
(2)PANEL COVER
(3)LIQUID CRYSTAL DISPLAY
(4)INTENSITY INCREASE CONTROL
(5)INTENSITY DECREASE CONTROL
(6)MODE CONTROL
(7)SET CONTROL
(8)INCREMENT CONTROL
(9)DECREMENT CONTROL
(10)LED

10.Portable powered muscle stimulators should not be used while
driving, operating machinery, or during any activity in which
involuntary muscle contractions may put the user at undue risk of
injury.

Chapter 4 : WARNINGS

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

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

3. 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.

4. Stimulation should not be applied transthoracically in that the
introduction of electrical current into the heart may cause cardiac
arrhythmias.

5. Stimulation should not be applied transcerebrally.

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

7. Stimulation should not be applied over, or in proximity to, cancerous
lesions.

Chapter 5: CONTRAINDICATION

Electrical stimulators should not be used on patients with cardiac
demand pacemakers.

Chapter 6: ADVERSE REACTIONS

Skin irritation and burns beneath the electrodes have been reported
with the use of electrical stimulators. If irritation occurs, discontinue
use and consult your physician.

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Chapter 8 : TECHNICAL SPECIFICATIONS

The technical specification details of Twin Stim® Plus are as follows:

MECHANISM TECHNICAL DESCRIPTION
01 Channel Four, isolated between channels
02 Pulse Amplitude Adjustable, 0-100 mA peak into 500 ohm

load each channel.
03 Wave Form Asymmetrical Bi-Phasic Square Pulse
04 Voltage 0 to 50V (Load: 500 ohm)
05 Power source Four AA batteries
06 Size 13.8cm(L) x 7.8cm(W) x 2.8cm(H)
07 Weight 425 grams with battery.
08 Pulse Rate Adjustable, from 2 to 150 Hz, 1 Hz/step
09 Pulse Width Adjustable, from 50 to 300 microseconds,

10 µs/step
10 On Time Adjustable, 2~90 seconds , 1 Sec./ step
11 Off Time Adjustable, 0~90 seconds , 1 Sec./ step
12 Ramp Time Adjustable, 1~8 seconds, 1 Sec./ step, The

“On” time will increase and decrease in the

setting value.
13 Mode Five TENS Modes: B(Burst), N(Normal),M

(Modulation),SD1( Strength Duration), SD2

Three EMS Modes:C(Constant) S

(Synchronous), A(Alternate)
14 Burst Mode Burst rate: Adjustable, 0.5 ~ 5Hz

Pulse width adjustable, 50~300µs

Frequency fixed = 100 Hz
15 Normal Mode The pulse rate and pulse width are

adjustable. It generates continuous

stimulation based on the setting value.
16 Modulation Mode Modulation mode is a combination of pulse

rate and pulse width modulation. The pulse

BACK

BACK

(11) BATTERY CASE
(12) BELT CLIP

SIDE

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