Kentro KTR-101 User manual

CE Technical file of Neck Electronic Muscle Stimulator
—— Instructions for Use
File No.: KTR-TCF-02-02-01-01
Revision: A/2
2862 Effective Date: 2023.03.28
1
Product Manual
Neck Electronic Muscle Stimulator
Model：KTR-101
Document Reference No：KTR-JS-101-11-01-A
Version: A/3
@Thank you for choosing and using this product, and please read this manual completely!
Shenzhen Kentro Medical Electronics Co., Ltd
Date: 2023-03-28 Version: A/2

CE Technical file of Neck Electronic Muscle Stimulator
—— Instructions for Use
File No.: KTR-TCF-02-02-01-01
Revision: A/2
2862 Effective Date: 2023.03.28
2
Contents
1. Product Introduction ..................................................................................................................................3
2. Product Intended use..................................................................................................................................3
3. Indication ...................................................................................................................................................3
4. Contraindication.........................................................................................................................................3
5. Warnings....................................................................................................................................................4
6. Precautions.................................................................................................................................................5
7. Adverse......................................................................................................................................................6
8. Primary Structure of Product .....................................................................................................................6
9. Product Main Features...............................................................................................................................7
10. Product Requirements and Major Parametric Description.....................................................................8
10.1 Product Power Requirement ..............................................................................................................8
10.2 Product Main Technical Parametric description ................................................................................8
10.3 Product Environmental Requirement.................................................................................................9
11. Method of application............................................................................................................................9
11.1 Power supply operation......................................................................................................................9
11.2 Functional operation.........................................................................................................................10
11.3 The use of rechargeable batteries.....................................................................................................12
11.4 The use of button battery to remote control .....................................................................................12
12. Safety Precautions................................................................................................................................13
13. Product maintenance............................................................................................................................16
14. EMC Declaration.................................................................................................................................18
15. Product Scrapping Disposal.................................................................................................................22
16. Accessories and Parts...........................................................................................................................22
17. The Paraphrase of Graphic Symbol .....................................................................................................22
18. Executive Standards.............................................................................................................................24
19. Attention ..............................................................................................................................................24
20. Contact Information.............................................................................................................................24

CE Technical file of Neck Electronic Muscle Stimulator
—— Instructions for Use
File No.: KTR-TCF-02-02-01-01
Revision: A/2
2862 Effective Date: 2023.03.28
3
1. Product Introduction
The design of KTR-101 Neck Electronic Muscle Stimulator is mainly based on the principle of
nourishing qi and blood according to traditional Chinese medicine. It helps to promote blood circulation to
remove meridian obstruction, dissipate wound, relieve pain and other types of muscle discomfort. It adopts
the summarized long-term clinical practice experience as well as combines with modern electronic science
and technology, developing a new generation of high-tech products neck prevention. The streamlined ring
design is accord with body neck physiological curvature. The device also adopts LF electrotherapy,
electro-heat equipment and vibromassage of resynchronization therapy to generate an efficient composite
energy field and through human body’s deep tissues and marrows. In the whole treatment process, its
physiological positional always maintain the correct posture , providing a scientific way to the treatment of
cervical vertebra disease. It will make the user enjoy multifunction system treatment at home with relaxation,
efficiency and pleasure.
2. Product Intended use
Promote neck blood circulation and relieve pain. Contact with skins of neck.Use Time :15-30min.
3. Indication
Neck electronic muscle stimulator is suitable for acute and chronic neck pain caused by poor neck blood
circulation.EMS is mainly to promote blood circulation; TENS is mainly to relieve pain.
4. Contraindication
1) Patients wired with cardiac pacemaker are prohibited to use!
2) Patients with haemorrhage after acute trauma or fractures or disabling wound after operation and those
at healing stage after the operation should not use.
3) It is contraindicated for those who has a skin perceptual disturbance or cannot feel the heat.
4) Neither the patients who has the symptom of consciousness disturbance onor children should not use it.
5) It is prohibited to use when bathing, sweating and sleeping.
6) The patient with cerebral hemorrhage which is in an unsteady phase should not use. The person who has

CE Technical file of Neck Electronic Muscle Stimulator
—— Instructions for Use
File No.: KTR-TCF-02-02-01-01
Revision: A/2
2862 Effective Date: 2023.03.28
4
sequela must be used under the supervision of doctors.
7) It is forbidden for those who has purulent inflammation, acute blood poisoning and continuous
hyperpyrexia.
8) It is forbidden for those who has acute cardiovascular and cerebrovascular diseases to use.
9) Those who has medical electronic equipment implanted in their bodies, such as cardiac pacemaker,
implanted defibrillator, or other implanted metallic or electronic devices. Such could cause electric shock,
burns, electrical interference, or even death.
10) Do not use on the open wounds, rashes, swollen, red, infected or inflamed areas or skin eruptions (e. g.,
phlebitis, thrombophlebitis, varicose veins); On top of, or in proximity to, cancerous lesions.
11) People with metal allergies are forbidden to use.
5. Warnings
1) The therapeutic apparatus cannot be used with the HF apparatus to avoid burns or damaged apparatus
2) If the patient himself uses the therapeutic apparatus and HF apparatus at the same time, the part of
massage plate may be cause burns on apparatus, it may also damage the apparatus; If use the apparatus near
(1 meter) the short wave or microwave therapeutic apparatus, the output of apparatus may be instability.
3) Do not modify this equipment without authorization of the manufacturer.
4) When need replacing the lithium batteries, please contact aftersales staff designated and authorized by
the manufacturer directly, its accessories shall not be replaceable.
5) Product battery replacement should be replaced by professional maintenance staff, otherwise it will
produce risk.
6) Shall not make personnel can no longer take care of themselves, infant, or not sensitive person use.
7) Simultaneous connection of a patient to a high frequency surgical ME equipment may result in burns at
the site of the stimulator electrodes and possible damage to the stimulator.
8) Operation in close proximity (e.g. 1 m) to a shortwave or microwave therapy ME equipment may
produce instability in the stimulator output.
9) Application of electrodes near the thorax may increase the risk of cardiac fibrillation.
10) Advice that stimulation should not be applied across or through the head, such as directly on the scalp,
eyes, covering the mouth, on the front of the neck, (especially the carotid sinus).
11) It should be shut down then using again when the apparatus is moved or changed the therapeutic parts in
the using process, otherwise there will be a strong stimulation.
12) It is not permitted to give children or people who were no ability to express consciousness to use.
13) If you feel unwell because of using the product, please stop using it immediately to the doctor consult.
14) Please pull up the power plugs when you are done or do not use the product.
15) Do not used in conjunction with other medical electronic devices, such as cardiac pacemaker, artificial
heart and lung and other medical electronic devices with fuels life, electrocardiograph and other medical
electronic devices, otherwise it will lead to danger.
16) Do not use the product in the place where is high heat, inflammable, electromagnetic radiation and

CE Technical file of Neck Electronic Muscle Stimulator
—— Instructions for Use
File No.: KTR-TCF-02-02-01-01
Revision: A/2
2862 Effective Date: 2023.03.28
5
humid.
17) Do not disassemble, repair and transform the therapeutic apparatus, otherwise cause failure or get an
electric shock accident.
18) The therapeutic apparatus should be placed in the position which is easy to move the plugs to use, it is
easy to move the plugs in emergency circumstances.
19) The long-term effects of chronic electrical stimulation are unknown, please do not use longer than 30
minutes every time.
20) Stimulation should not be applied over the carotid sinus nerves, particularly in patients with a known
sensitivity to the carotid sinus reflex.
21) Stimulation should not be applied transthoracically in that the introduction of electrical current into the
heart may cause cardiac arrhythmias.
22) Stimulation should not be applied transcerebrally.
23) Stimulation should not be applied over swollen, infected, or inflamed areas or skin eruptions, e.g.,
phlebitis, thrombophlebitis, varicose veins, etc.
24) Stimulation should not be applied over, or in proximity to, cancerous lesions.
6. Precautions
1) Safety of stimulators for use during pregnancy has not been established.
2) Caution should be used for patients with suspected or diagnosed heart problems.
3) Caution should be used for patients with suspected or diagnosed epilepsy.
4) Caution should be used in the presence of the following:
5) When there is a tendency to hemorrhage following acute trauma or fracture;
6) Following recent surgical procedures when muscle contraction may disrupt the healing process;
7) Over the menstruating or pregnant uterus; and
8) Over areas of the skin which lack normal sensation.
9) 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.
10) Electrode placement and stimulation settings should be based on the guidance of the prescribing
practitioner.
11) The device should be kept out of the reach of children.
12) The devcie should be used only with the leads and remote control recommended for use by the
manufacturer.
13) Don’t use while driving, operating machinery, or during any activity in which involuntary muscle
contractions may put the user at undue risk of injury.
14) The maximum temperature of heating is 43℃, single use time :15-30min , do not use it for a long time
to avoid burning the skin.
15) If you feel uncomfortable during use, please turn off the power immediately.

CE Technical file of Neck Electronic Muscle Stimulator
—— Instructions for Use
File No.: KTR-TCF-02-02-01-01
Revision: A/2
2862 Effective Date: 2023.03.28
6
7. Adverse
Be caution that research and statistics show that the use of stimulator might lead the skin beneath the
electrodes to irritation and burn.
8. Primary Structure of Product
The neck electronic muscle stimulator mainly consists of host, electro-heat equipment, and wired hand
controller/remote control and power adapter. The major structure and components are shown as below:
Remote control
Power adapter

CE Technical file of Neck Electronic Muscle Stimulator
—— Instructions for Use
File No.: KTR-TCF-02-02-01-01
Revision: A/2
2862 Effective Date: 2023.03.28
7
Host
9. Product Main Features
The product is designed on the basis of ergonomics which is in line with the neck curve and of
aesthetics and science.
The LF electric pulse, magnetic effect, far IR pyretic moxibustion, vibrating massage and annular
traction all comprise a resynchronization therapy to generate an efficient composite energy field;
It adopts the latest 3D intelligent mounting technology, and according to your neck curve adjust
electrode easily, so that using is more comfortable;

CE Technical file of Neck Electronic Muscle Stimulator
—— Instructions for Use
File No.: KTR-TCF-02-02-01-01
Revision: A/2
2862 Effective Date: 2023.03.28
8
There are two automatic combinational massage modes and four manual massage modes to be fit for
wider range of people, and it can be selected according to different needs.
It contains a number of built-in healthy magnets, which aims to form a magnetic therapy to body
acupoints. The principle lies in adjusting a balance of yin and yang (stated in traditional Chinese
medicine) and improving human body’s microcirculation;
It contains a LED indicator light displayer for simple clarified operation, which is a humanized design.
10. Product Requirements and Major Parametric Description
10.1 Product Power Requirement
a) Host power supply: 100-240VAC, 50/60Hz 0.2Aof frequency converted to DC6V 800mA
Internal electric source: 3.7V DC.1450mAh
Power supply of remote control: CR2032 3VDC of Button battery
b) Device safety classes: class II type BF
c) Power adapter specification
Input: 100-240VAC, 50/60Hz 0.2A of frequency
Output: DC6V 800mA
Manufacturer: Chousen International (Shenzhen) Co., Ltd
d) Lithium battery specification
Nominal capacity: 1450mAh
Nominal voltage: 3.7VDC
Size: 8.6X33X43mm
Weight: about 25g
10.2 Product Main Technical Parametric description
a) Impulse frequency: 1Hz~400Hz.
b) Pulse width: 20μs~200μs.
c) Impulse waveform: square wave
d) Pulse duration: ≤3 seconds
e) The product output has no the DC component.
f) The individual pulsing electric quantity when in the maximum output amplitude: >7μC.
g) The maximum output energy of individual pulse: ≤300mJ.
h) The effective value of maximum output amplitude: ≤25V（50mA）.
i) In the open measurement, the output voltage peak: ≤500V.
j) Influence of output end open circuit and short circuit: it is able to support the influence of output end
open and short circuit, and its performance will not be allowed to weaken.

CE Technical file of Neck Electronic Muscle Stimulator
—— Instructions for Use
File No.: KTR-TCF-02-02-01-01
Revision: A/2
2862 Effective Date: 2023.03.28
9
k) Adjustment of output amplitude: continuous and balanced, the minimum output is not more than 2% of
maximum output.
l) Rated load impedance: 500Ω, ±10% franchise.
m) The timer of therapeutic equipment: 15 minutes, ±10% franchise.
n) Thermal therapy temperature: it should be in the range of 38℃～48℃. (under the 23℃±2 ℃
environment)
o) Safety classification: internal electric source class and type BF equipment
p) Boundary dimension: Host (length 174mm * width 144mm * height 60.5mm)
Controller (length 88mm * width 40.5mm * height 19.5mm)
q) Product software version No.:A/0
r) Service life: 3 years
10.3 Product Environmental Requirement
a) Normal work environmental requirements:
Environment temperature: +5℃-+40℃; Environment humidity: 15%-93%RH; Atmospheric
environment conditions: 700hPa-1060hPa.
b) Storage environment requirements:
Environment temperature: -25℃-+55℃; Environment humidity: 0-93%RH;Atmospheric environment
conditions: 700hPa-1060hPa.
c) Transport environment requirements:
Environment temperature: -10℃-40℃; Environment humidity: 15%-93%RH;
Atmospheric environment conditions: 700hPa-1060hPa.
11. Method of application
11.1 Power supply operation
1) Adapter to power supply
Insert the output end of power adapter (switched-mode power supply) into the hole below the average of
therapeutic equipment, and next insert the plug foot of the output end of power adapter into the AC
power outlet.
2) The built-in rechargeable battery

CE Technical file of Neck Electronic Muscle Stimulator
—— Instructions for Use
File No.: KTR-TCF-02-02-01-01
Revision: A/2
2862 Effective Date: 2023.03.28
10
The built-in rechargeable battery can be powered without the external power supply.
3) The installation of battery
The remote control uses the CR2032 Button battery, the positive pole upwards when is installed.
11.2 Functional operation
1）User should towel the cervical part and conductive plate with water, then press therapeutic apparatus close
to the neck. If there is perspiration in the cervical part, it should be cleaned.
2）Use the remote control and press the ― ‖ button to turn on the machine. The buzzer of host machine
can make a ―Beep‖sound, then the power indicator light goes on. After that, the working routine gets
started and the LCD backlight of remote control goes on, which is equipped with a following set for
entering the automatic mode, that is:
A. hi-heat;
B. global functional vibromassage;
C. the first gear of vibromassage strength;
D. time for 15 minutes.
If you want to stop using the device, you can press ― ‖ button to shut it down.
When remote control is being operated, its infrared launch window should correspond with an infrared
launch window of therapeutic apparatus. The apparatus will make a ―Beep‖sound when it receives an
infrared signal successfully.
3）The use of the button ― ∧‖、―∨‖ of remote control
― ∧‖button as an option to Up select; ―∨‖ button as an option to Down select
4）The use of the button ―＜‖、―＞‖ of remote control
―＜‖ can adjust the figure of selected item smaller;
―＞‖can adjust the figure of selected item more.
5）Mode switch
Select the term by ― ∧‖、―∨‖ buttons, press ―＜‖、―＞‖ button to switch the following six
modes:

CE Technical file of Neck Electronic Muscle Stimulator
—— Instructions for Use
File No.: KTR-TCF-02-02-01-01
Revision: A/2
2862 Effective Date: 2023.03.28
11
①automatic mode: vibration + heating, heating + pulse, heating + pulse, heating, vibration, electric
pulse auto-cycle running;
②vibration + heating;
③heating + pulse;
④heating;
⑤vibration;
⑥electric pulse.
6）Intensity adjustment
Select the item― ‖ by ― ∧‖、―∨‖button. Press the ―＜‖、―＞‖button to switch the intensity of
electric pulse or vibration. There are 16 gears intensity of electric pulse, 3 gears of vibration.
7) Heating mode switch
Select the ― ‖ item by the ― ∧‖、―∨‖ button. Press the ―＜‖、―＞‖button to switch the heating
mode, there is hi-heat (H), med-heat (L) and no heating (O).
8）Electric pulse mode switch
Select the item by the ―∧‖、―∨‖ button. Press the ―＜‖、―＞‖ button switch the electric pulse
mode, and there are six modes as follows:
Electric pulse mode 1: as the auto-cycle mode, cyclical scart, massage, malaxation mode;
Electric pulse mode 2: as the auto-cycle mode, cyclical massage, scart, thump mode;
Note: Electric pulse mode 1 and mode 2 are circulation the follow four modes waveform.
Electric pulse mode 3: as the scart mode, Frequency 150-400 Hz, pulse width 20-120μS;
Electric pulse mode 4: as the massage mode, Frequency 70-120 Hz, pulse width 20-120μS;
Electric pulse mode 5: as the malaxation mode, Frequency 20-70 Hz, pulse width20-120μS;
Electric pulse mode 6: as the thump mode, Frequency1-20 Hz, pulse width80-200μS.
9）Vibration mode switch
Select the item, press the ―＜‖、―＞‖ button switch the vibration mode, and there are six modes,
respectively as follows:
Vibration mode 1: as the auto-cycle mode, cyclical frequent vibration, rub slightly, thump, shiatsu and
rolling mode;
Vibration mode 2: as the frequent vibration mode;
Vibration mode 3: as the rub slightly mode;
Vibration mode 4: as the thump mode;
Vibration mode 5: as the shiatsu mode;
Vibration mode 6: as the rolling mode.

CE Technical file of Neck Electronic Muscle Stimulator
—— Instructions for Use
File No.: KTR-TCF-02-02-01-01
Revision: A/2
2862 Effective Date: 2023.03.28
12
10）The adjustment of timing
Select the item by ―∧‖ and ―∨‖ button. Press the ―＜‖ and ―＞button to switch the timing,
the adjustable range is 5 to 30 minutes, it can increase or decrease 5 minutes each pressing.
Precautions
（1）It is suggested that using the therapeutic apparatus 2 times a day, vibration and electric pulse
10~15minutes every time, heating 15~30 minutes every time.
11.3 The use of rechargeable batteries
1) In the course of using the therapeutic apparatus, it shows the electric quantity of internal lithium battery
is not enough when you heard ―DI‖buzzing 3times in row, you can charge the battery using adapter and
turn the toggle switch to ―charge‖position, then the green indicator of the power supply is flashing;
after the battery is charging fully, the green indictor is normal on. The charging time is about 3~4 hours.
2) It can be used about one week (30 minutes a day) after fully charged.
3) Under a normal using condition, the rechargeable batteries life ≥500 times charge and discharge, can use
about 3 years (30 minutes a day).
4) When the rechargeable batteries are not used for a long time, it will reduce the service life of
rechargeable batteries, it is suggested that at least have a full charging every month.
5) The discarding method of the post-batteries should be deal with according to the urban environmental
protection.
11.4 The use of button battery to remote control
1) The remote control adopts the ―CR2032‖ button battery that can be used for about 60 days (by the
standard of using it 30 minutes a day).
2) When pressing the button, the brightness of LCE backlight of remote control is distinct weakening or
can only remote close to the host infrared launch window, showing the electric quantity of battery is not
enough and please replace the new battery.
3) If the product is not used for a long time, please take out the battery, otherwise it may cause the battery
leakage and cause the machine error.
4) Do not use the outside of the specified battery.
5) Do not misplace the positive and negative pole of battery, the positive pole up, and the negative pole
down.
6) Do not use this battery under the environment which more than 45℃, otherwise it will affect the
performance and life of the battery.
7) The discarding method of the post-batteries should be deal with according to the urban environmental
protection.

CE Technical file of Neck Electronic Muscle Stimulator
—— Instructions for Use
File No.: KTR-TCF-02-02-01-01
Revision: A/2
2862 Effective Date: 2023.03.28
13
12. Safety Precautions
■The manual said that the purpose of warning sign and legend is safe and proper using the product by yours,
and prevents the harm to you and others.
■The warning sign and legend as well as their meaning is as follows:
Warning sigh
Meaning
Contraindication
It shows that it will appear the dangerous of casualties or serious injury in the error
use.
Warning
It shows that it will appear the possibility of casualties or serious injury in the
error use.
Precautions
It shows that it will appear the possibility of personal injury or damaged goods in
the error use.
Warning
1) The therapeutic apparatus cannot be used with the HF apparatus to avoid burns
or damaged apparatus
2) If the patient himself uses the therapeutic apparatus and HF apparatus at the
same time, the part of massage plate may be cause burns on apparatus, it may
also damage the apparatus; If use the apparatus near (1 meter) the short wave or
microwave therapeutic apparatus, the output of apparatus may be instability.
3) Do not modify this equipment without authorization of the manufacturer.
4) When need replacing the lithium batteries, please contact aftersales staff
designated and authorized by the manufacturer directly, its accessories shall not
be replaceable.
5) Product battery replacement should be replaced by professional maintenance
staff, otherwise it will produce risk.
6) Shall not make personnel can no longer take care of themselves, infant, or not
sensitive person use.
7) Simultaneous connection of a patient to a high frequency surgical ME
equipment may result in burns at the site of the stimulator electrodes and
possible damage to the stimulator.
8) Operation in close proximity (e.g. 1 m) to a shortwave or microwave therapy
ME equipment may produce instability in the stimulator output.
9) Application of electrodes near the thorax may increase the risk of cardiac

CE Technical file of Neck Electronic Muscle Stimulator
—— Instructions for Use
File No.: KTR-TCF-02-02-01-01
Revision: A/2
2862 Effective Date: 2023.03.28
14
fibrillation.
10) Advice that stimulation should not be applied across or through the head, such
as directly on the scalp, eyes, covering the mouth, on the front of the neck,
(especially the carotid sinus).
11) It should be shut down then using again when the apparatus is moved or
changed the therapeutic parts in the using process, otherwise there will be a
strong stimulation.
12) It is not permitted to give children or people who were no ability to express
consciousness to use.
13) If you feel unwell because of using the product, please stop using it
immediately to the doctor consult.
14) Please pull up the power plugs when you are done or do not use the product.
15) Do not used in conjunction with other medical electronic devices, such as
cardiac pacemaker, artificial heart and lung and other medical electronic
devices with fuels life, electrocardiograph and other medical electronic devices,
otherwise it will lead to danger.
16) Do not use the product in the place where is high heat, inflammable,
electromagnetic radiation and humid.
17) Do not disassemble, repair and transform the therapeutic apparatus, otherwise
cause failure or get an electric shock accident.
18) The therapeutic apparatus should be placed in the position which is easy to
move the plugs to use, it is easy to move the plugs in emergency circumstances.
19) The long-term effects of chronic electrical stimulation are unknown, please do
not use longer than 30 minutes every time.
20) Stimulation should not be applied over the carotid sinus nerves, particularly in
patients with a known sensitivity to the carotid sinus reflex.
21) Stimulation should not be applied transthoracically in that the introduction of
electrical current into the heart may cause cardiac arrhythmias.
22) Stimulation should not be applied transcerebrally.
23) Stimulation should not be applied over swollen, infected, or inflamed areas or
skin eruptions, e.g., phlebitis, thrombophlebitis, varicose veins, etc.
24) Stimulation should not be applied over, or in proximity to, cancerous lesions.
Contraindication
1) Patients wired with cardiac pacemaker are prohibited to use!
2) Patients with haemorrhage after acute trauma or fractures or disabling wound

CE Technical file of Neck Electronic Muscle Stimulator
—— Instructions for Use
File No.: KTR-TCF-02-02-01-01
Revision: A/2
2862 Effective Date: 2023.03.28
15
after operation and those at healing stage after the operation should not use.
3) It is contraindicated for those who has a skin perceptual disturbance or cannot
feel the heat.
4) Neither the patients who has the symptom of consciousness disturbance onor
children should not use it.
5) It is prohibited to use when bathing, sweating and sleeping.
6) The patient with cerebral hemorrhage which is in an unsteady phase should not
use. The person who has sequela must be used under the supervision of doctors.
7) It is forbidden for those who has purulent inflammation, acute blood poisoning
and continuous hyperpyrexia.
8) It is forbidden for those who has acute cardiovascular and cerebrovascular
diseases to use.
9) Those who has medical electronic equipment implanted in their bodies, such as
cardiac pacemaker, implanted defibrillator, or other implanted metallic or
electronic devices. Such could cause electric shock, burns, electrical
interference, or even death.
10) Do not use on the open wounds, rashes, swollen, red, infected or inflamed areas
or skin eruptions (e. g., phlebitis, thrombophlebitis, varicose veins); On top of,
or in proximity to, cancerous lesions.
11) People with metal allergies are forbidden to use.
Precautions

CE Technical file of Neck Electronic Muscle Stimulator
—— Instructions for Use
File No.: KTR-TCF-02-02-01-01
Revision: A/2
2862 Effective Date: 2023.03.28
16
1) Safety of stimulators for use during pregnancy has not been established.
2) Caution should be used for patients with suspected or diagnosed heart
problems.
3) Caution should be used for patients with suspected or diagnosed epilepsy.
4) Caution should be used in the presence of the following:
5) When there is a tendency to hemorrhage following acute trauma or fracture;
6) Following recent surgical procedures when muscle contraction may disrupt the
healing process;
7) Over the menstruating or pregnant uterus; and
8) Over areas of the skin which lack normal sensation.
9) 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.
10) Electrode placement and stimulation settings should be based on the guidance
of the prescribing practitioner.
11) The device should be kept out of the reach of children.
12) The devcie should be used only with the leads and remote control
recommended for use by the manufacturer.
13) Don’t use while driving, operating machinery, or during any activity in which
involuntary muscle contractions may put the user at undue risk of injury.
14) The maximum temperature of heating is 43℃, single use time :15-30min , do
not use it for a long time to avoid burning the skin.
15) If you feel uncomfortable during use, please turn off the power immediately.
Adverse
Be caution that research and statistics show that the use of stimulator might
lead the skin beneath the electrodes to irritation and burn.
13. Product maintenance
1) Before opening the power switch, please check the power supply and power plugs whether is in the
normal working condition, each connecting parts whether is connected in good;

CE Technical file of Neck Electronic Muscle Stimulator
—— Instructions for Use
File No.: KTR-TCF-02-02-01-01
Revision: A/2
2862 Effective Date: 2023.03.28
17
2) If this apparatus there is no evidence in the charging status, you should check whether there is a power
supply, the power plugs are plugged in good, host toggle switch is in the ―charging‖position;
3) If the apparatus runs normally, show disorderly and button invalidly after charging. To turn it off after a
few seconds and then opening, if still not normal, check the voltage whether is more than or less than
the specified value;
4) If the remote control displays normally, but the host cannot run, please check the infrared launch
window to remote control whether is corresponding with infrared launch window to therapeutic
apparatus when operating the remote control, the apparatus will have a ―DI‖hint while the apparatus
receives infrared signal successfully;
5) If all operation of the apparatus is normal but without output (the user without feelings) after charging.
Please check the apparatus’ electrode whether direct contacted with cervical skin, the contacting parts
whether has hair, clothes and so on;
6) While cleaning, shutdown first, let the power line stay away from the electric supply socket. You can
wipe by using soft cloth or towel with a little water and after dry.
7) After each use, please clean conducting plate, you can wipe by using soft cloth or towel with a little
water and after dry, when conducting plate is particularly dirt, you can wipe by using soft cloth with a
little medicinal alcohol (alcohol concentration as 75%).
8) The apparatus should be placed in the place which is dry, ventilated and good insulation use.
9) When the apparatus is moved, must be handled with care, avoiding the shake.
10) The apparatus should be checked the power plugs, to check whether the output is good, if has abnormal
conditions, you should pay attention to it and service it in time.
11) The apparatus’ shell board should be pay attention to protection, avoiding the abrasion.
12) The non-professional cannot disassemble the host to avoid getting an electric shock or damaging the
apparatus, an accident can happen because of it, all at your peril.
13) The product has a free warranty for one year and provided by the dealer, and there is a compensable
maintenance for the goods which expired for the warranty period
14) Common faulted elimination:
Fault phenomenon
The items need to be affirmed
Handling method
The apparatus cannot boot
①the host toggle switch whether is
in ―ON‖ position
Confirm whether the host toggle
switch whether is in the ―ON‖
position
②the electric quantity of inner
battery whether is not enough
If the electric quantity is not
enough please use the external
power source
③the power line whether has been
connected
Check the power line whether
connected to the host;

CE Technical file of Neck Electronic Muscle Stimulator
—— Instructions for Use
File No.: KTR-TCF-02-02-01-01
Revision: A/2
2862 Effective Date: 2023.03.28
18
④the power supply whether is
normal
Check the power plugs supply
whether is normal
⑤when operated the remote
control, the infrared launch
window to remote control whether
is corresponding with the infrared
launch window to therapeutic
apparatus
The infrared launch window to
remote control is corresponding
with the infrared launch window
to therapeutic apparatus
Cannot charging or without
charging display
①whether the adapter has
connected good
Check the power line whether
connected to the host
②the host toggle switch whether
is in ―charge‖ position
Confirm the host toggle switch
whether is in ―Charge‖ position
Display normally, but
without response or feeling
①the apparatus’ electrode whether
direct contacted to cervical skin
Check the apparatus’ electrode
whether direct contacted to
cervical skin
②the parts contacted with
electrode whether has hair, clothes
and so on
Check the parts contacted with
electrode whether has hair,
clothes and so on
14. EMC Declaration
1. This product needs special precautions regarding EMC and needs to be installed and put into
service according to the EMC information provided, and this unit can be affected by portable and
mobile RF communications equipment.
2. Caution: This unit has been thoroughly tested and inspected to assure proper performance and
operation!
3. Caution: this machine should not be used adjacent to or stacked with other equipment and that if
adjacent or stacked use is necessary, this machine should be observed to verify normal operation in
the configuration in which it will be used.
Warning The use of ACCESSORIES, transducers and cables other than those specified, with the
exception of transducers and cables sold by the MANUFACTURER of the KENTRO Neck Electronic

CE Technical file of Neck Electronic Muscle Stimulator
—— Instructions for Use
File No.: KTR-TCF-02-02-01-01
Revision: A/2
2862 Effective Date: 2023.03.28
19
Muscle Stimulator as replacement parts for internal components, may result in increased EMISSIONS or
decreased IMMUNITY of the Neck Electronic Muscle Stimulator.
Table 1
Guidance and manufacturer’s declaration – electromagnetic emissions
The MODEL KTR-101 is compliance for each EMISSIONS test specified by the standard, e.g.
EMISSIONS class and group.
Emissions
Compliance
Electromagnetic environment-- guidance
RF emissions
CISPR 11
Group 1
The MODEL KTR-101 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 emissions
CISPR 11
Class B
The MODEL KTR-101 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

CE Technical file of Neck Electronic Muscle Stimulator
—— Instructions for Use
File No.: KTR-TCF-02-02-01-01
Revision: A/2
2862 Effective Date: 2023.03.28
20
Table 2
Guidance and manufacturer’s declaration – electromagnetic immunity
The MODEL KTR-101 is compliance for each IMMUNITY test specified by the standard, e.g. IMMUNITY
test level.
Immunity test
IEC 60601-1-2
test level
Compliance level
Electrostatic
discharge (ESD)
IEC 61000-4-2
±8 kV contact
±2 kV, ±4 kV, ±8 kV, ±15 kV air
±8 kV contact
±2 kV, ±4 kV, ±8 kV, ±15 kV air
Radiated RF EM fields
IEC 61000-4-3
10V/m
80MHz-2.7GHz
80% AM at 1kHz
10V/m
80MHz-2.7GHz
80% AM at 1kHz
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV
100 kHz repetition frequency
±2 kV
100 kHz repetition frequency
Surge
IEC 61000-4-5
±0.5 kV, ±1 kV line-to-line;
±0.5 kV, ±1 kV and ±2 kV
line-to-ground;
±0.5 kV, ±1 kV line-to-line;
±0.5 kV, ±1 kV, and ±2 kV
line-to-ground;
Conducted disturbances
induced by RF fields
IEC 61000-4-6
3V
0.15MHz-80MHz
6V in ISM and amateur radio bands
between 0.15MHz and 80MHz
80% AM at 1kHz
3V
0.15MHz-80MHz
6V in ISM and amateur radio bands
between 0.15MHz and 80MHz
80% AM at 1kHz
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
0% UT: 0.5 cycle a)
At 0o, 45o, 90o, 135o, 180o, 225o, 270o,
and 315o.
0% UT: 0.5 cycle a)
At 0o, 45o, 90o, 135o, 180o, 225o, 270o,
and 315o.
0% UT: 1 cycle
70% UT: 25/30 cyclesb)
Single phase: at 0o
0% UT: 1 cycle
70% UT: 25/30 cyclesb)
Single phase: at 0o
0% UT: 250/300 cyclesb)
0% UT: 250/300 cyclesb)
Power frequency
(50/60 Hz)
magnetic field
30 A/m
50 Hz or 60 Hz
30 A/m
50 Hz or 60 Hz