1. Product Introduction
2. Product Intended use
3. Contraindication and Adverse
Reaction
4. Primary Structure of Product
The Transcutaneous Electrical Nerve Stimulators is a portable and battery
powered multifunctional device.
The Transcutaneous Electrical Nerve Stimulators (model: KTR-2610)
offering Transcutaneous Electronic Nerve Stimulator (TENS), Electronic
Muscle Stimulator (EMS) and FITNESS. It has 50 operation modes, which
can give certain electrical pulse through electrode pads placed on the skin
to help users to enjoy body stimulation.
The electronic stimulatory module has the operating elements of ON/OFF
Key, Display screen, Mode Selection key and Intensity Modification keys.
The LCD display screen can show selected mode and program, output
intensity, stimulate frequency, and time remaining of an application mode.
The device is equipped with accessories of electrode pads, electrode wires,
and batteries. The electrode wire is used to connect the patches to the main
unit.
The electrode pads are complying with the biocompatibility standards ISO
10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization), are
interchangeable.
3.1 Contraindication
a) The long-term effects of chronic electrical stimulation to the human body
are not known.
b) Patients with cardiac pacemaker are disabled!
c) Patients with suspected or confirmed have epilepsy, heart disease,
pregnancy or
menstruating women are prohibited.
d) Treatment parts have the haemorrhage after acute trauma or fractures,
disabling wound healing stage after the operation.
e) Treatment is not sensitive to heat or electrical stimulation of the skin
patients disabled.
f) Disturbance of consciousness or disabled children.
g) Treatment of swelling, skin infection or with skin disease, phlebitis
patients disabled.
h) With wet skin after shower, sweating and disabled when you go to sleep.
i) Driving traffic tools or disable during movement.
j) Metal allergies are disabled.
The Transcutaneous Electrical Nerve Stimulators mainly consists
of main unit, electrode patches and electrode wires. The primary structure
of main unit as shown below:
3.2 Adverse Reaction
1) You may experience skin irritation and burns beneath the stimulation
electrodes applied to your skin;
2) You may experience headache and other painful sensations during or
following the application of electrical stimulation near your eyes and to your
head and face;
You should stop using the device and should consult with your physician if
you experience adverse reactions from the device.
TENS (Mode 1~20)
To be used for temporary relief of pain associated with sore and aching
muscles in the shoulder, waist, back, back of the neck, arm, leg, and foot
due to strain from exercise or normal household work activities by applying
current to stimulate nerve.
EMS (Mode 21~40)
It is intended for relaxation of muscle spasm, prevention or retardation of
disuse atrophy, increase local blood circulation, and muscle re-education.
FITNESS (Mode 41~50)
Improvement of abdominal tone, strengthening of the abdominal muscle
development of firmer abdomen.
01
02
03
