Kentro KTR-2610 User manual

Thanks for choosing this product, please read this User Manual carefully before use!
Please properly keep this warranty as it will be used in
after-sales repair and maintenance after purchasing. Its
service details are as follows:
1. Thanks for your purchase. Please read carefully this
manual and fill in the following form before use.
2. Under normal use, this product enjoys 1-year free repair
and maintenance upon presentation of this warranty. All
human failures occur within the warranty period will be
maintained by us free of charge, but the costs for parts
and components and transport will be undertaken by the
purchaser. However, man-made damages, such as
water
enters inside the product, product drops on the ground or
violation opera
tion, are not covered by this warranty.
3. Product maintenance beyond the warranty period will be
conducted by us free of charge, but the costs for parts
and components and transport will be undertaken by the
purchaser.
Quality Guarantee
KTR-2610
Common
name
Model
Purchaser
Telephone
Address
Date of
purchase
Agent
KTR-2610
User Manual
KTR-JS-2610-11-01-A
L130 x W120mm
80G书写纸/骑马钉
深圳市健得龙医疗电子有限公司
编制
审核
批准
产品名称
说明书
KTR-2610
2020.09.10
2020.09.10
A/1
骑马钉
单色印刷
产品型号
日期
日期
日期
文件编号
要 求
版 本
尺 寸
材 质
颜 色
产品名称
经皮神经刺激器
Transcutaneous Electrical
Nerve Stimulators
Transcutaneous Electrical
Nerve Stimulators

Content
01
1. Product Introduction. ............. ..02
2. Product Intended use.....
.... ..02
3. Contraindication.
....... ... . 03
4. Primary Structure of Product...
......... 03
5. Product Main Features.
.. .. ... .... 04
6.
Product Requirements
and Major Parametric Description
................... 04
7. Method of application
. .. ........ 06
8. Safety Precautions
........... 07
9. Product maintenance
............ 10
10. Product Scrap Processing.
............ 11
11. Accessories and Parts
........... 11
12. The Paraphrase of Graphic Symbol
.......... 11
13. Executive Standards
........... 13
Appendix EMC Declaration
......................... 13

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

5. Product Main Features
6 Product Requirements and
Major Parametric Description
6.2 Product Main Technical Parametric description
a)Impulse frequency:
TENS:(20-100)Hz, EMS:(1-15)Hz, FITNESS:(2-16)Hz.
b)Pulse width:
TENS: 120μs, EMS: 200μs, FITNESS: 200μs.
c)Impulse waveform: square wave
d)The individual pulsing electric quantity when in the maximum output
amplitude: >7μC.
e)The maximum output energy of individual pulse: ≤300mJ.
f)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.
g)Adjustment of output amplitude: 0-16 levels.
h)The timer of therapeutic equipment: 15 minutes, 30 minutes, 45 minutes,
±10% franchise.
i)Safety classification: internal electric source class and type BF equipment
j)Boundary dimension:
Main unit: 122mm * 55mm * 15.7mm;
Electrode Pads: 3 kinds
EPAD-D01: 70×52mm EPAD-D02: 50×50mm EPAD-D03: 50×50mm
k)Service life: the shelf life of subject device is 2 years; the use life of the
small Electrode Pad is 80 times and shelf life is 2 years
6.3 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℃-+70℃;
Environment humidity: 0-93%RH; Atmospheric
Environment conditions: 700hPa-1060hPa.
c)Transport environment requirements:
Environment temperature: -25℃-+70℃;
Environment humidity: 0-93%RH; Atmospheric
Environment conditions: 700hPa-1060hPa.
Note: It needs at least 30 minutes for device to return to normal operating
temperature from the minimum/maximum storage temperature.
■The design is on the basis of ergonomics and is beautiful science,
compact easy to carry;
■The LF electric pulse come into being an efficient composite energy field;
■Multi-function and multi-site remission,
■There are alternative functional modules, adjustable treatment time, and
adjustable intensity;
■There is LCD display;
04 05
6.1 Product Power Requirement
a) Power source: 3.7V/250mAh lithium battery
b) Device safety classes: class II type BF
Fig 1. Primary structure of main unit

7 Method of application
8 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:
7.1 Power supply operation
1)Charging of lithium battery by connecting to the device through the
adapter.
2)Connect the components
According to Fig 1, connect the main unit and electrode pads with the
electrode wires.
3)Turn on/off
Press the “on/off” key can turn on the main unit, the power light is lightened,
the working routine is started and the LCD backlight of remote control is
lightened.
Press the “On/Off” button again, the machine shut down and the screen is off.
7.2 Functional operation
1）Attach the electrode pads to the stimulate parts, if there is a perspiration
in your body, it must be clean to use.
2）Press the “on/off” key can turn on the main unit. The device would be
default mode of TENS, there are 20 fixed programs.
3）The use of the key “ ∧”、“∨” of program selection:
“ ∧”key as an option to Up select; “∨” key as an option to Down select
4）The use of the key “+”, “-” of intensity adjustment for channel 1 and
channel 2.
Each channel has 0-16 levels.
“+” can enhance intensity;
“-” can decrease intensity.
5）Mode switch
Short press “F” key to switch three major modes of TENS, EMS, and
FITNESS;
6）The adjustment of timing
Long press “F” key for 1.5 seconds to set up the stimulation time of 15
minute, 30 minute, and 45 minute;
It shows that it will appear the possibility of
casualties or serious injury in the error use.
It shows that it will appear the possibility of
personal injury or damaged goods in the error use.
Warning
attention
Warning
Sigh Meaning
It shows that it will appear the dangerous of
casualties or serious injury in the error use.
using
contraindication
06 07
7) There are 20 fixed programs for TENS, 20 fixed programs for EMS and
10 fixed programs for FITNESS.
8) The output frequency of the product is displayed on the LCD.
7.3 The use of battery
1)The device powered by the lithium battery, which can rechargeable
through the adapter.
2)When pressing the key, the brightness of LCD is distinct weakening or the
stimulation intensity changes is very slightly when press the key of intensity
adjustment, showing the electric quantity of battery is not enough and
please charging in time.
3)If it is not used for one month or long term, please fully charge it first.
4)Do not use the device under the environment which more than 45℃,
otherwise it will affect the performance and life of the battery.
5)The discarding method of the post-batteries should be deal with according
to the urban environmental protection.

using contraindication
⑴It is contraindicated for use by those who has a skin perceptual
disturbance or is not sensitive about the heat.
⑵It is prohibited to use when bathing, sweating and sleeping.
⑶The patient with cerebral hemorrhage: It should be disabled in
unsteady phase; the person who has sequela must be used under
supervision of doctors.
⑷It is contraindicated for use by those who has purulent
inflammation, acute blood poisoning and continuous hyperpyrexia.
⑸It is contraindicated for use by those who has acute
cardiovascular and cerebrovascular diseases.
Please stop using it immediately to the doctor to consult when
unwell felt or skin complaint in the process of use.
aftersales staff designated and authorized by the manufacturer
directly, its accessories shall not be replaceable.
-- Product battery replacement should be replaced by
professional maintenance staff, otherwise it will produce risk.
--Shall not make personnel can no longer take care of
themselves,nfant, or not sensitive person use.
-- Simultaneous connection of a patient to a high frequency
surgical ME equipment may result in burns at the site of the
stimulator electrode pads and possible damage to the stimulator.
-- Operation in close proximity (e.g. 1 m) to a shortwave or
microwave therapy ME equipment may produce instability in the
stimulator output.
--Application of electrode pads near the thorax may increase the
risk of cardiac fibrillation.
--Advice that stimulation should not be applied across or through
the head, directly on the eyes, covering the mouth, on the front of
the neck, (especially the carotid sinus), or from electrode pads
placed on the chest and the upper back or crossing over the heart.
--Prevent inhalation or accidental swallowing of small parts
(including 3*AAA LR03 battery).
-- Prevent sharp parts from damaging the product.
-- Do not use accessories not specified by the manufacturer.
Please do not use in the parts which is nearest heart, head, eyes,
front neck (especially the carotid artery), lower back, oral cavity or
pudendum, skin disease.
precautions
Pregnant women and women’s menstrual period, person with
sensitive skin, heart disease, abnormal blood pressure, malignant
tumors, cerebrovascular patients , patients with acute disease or
other person treated by doctor must consult a doctor rear can use
this product.
08 09
-- The therapeutic apparatus cannot be used with the HF
apparatus to avoid burns or damaged apparatus
-- 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.
-- It will increase a danger of heart fibrillation by using electrode
pads close to the chest.
-- Do not modify this equipment without authorization of the
manufacturer
--When need replacing the lithium batteries, please contact
attention
⑴It 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.
⑵It is not permitted to give children or people who were no ability
to express consciousness to use.
⑶If you feel unwell because of using the product, please stop
using it immediately to the doctor consult.
⑷Please pull up the power plugs when you are done or do not
use the product.
⑸Do 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.

9 Product maintenance
The therapeutic equipment belongs to medical device, if the complete
machine is already aging and is not able to use, the process mode
according to the local legislation carry through scrap processing.
10 Product Scrap Processing
Main unit 1 pcs Charging Cable 1 pcs
Electrode pads 2 pcs Electrode wire 2 pcs
Manual 1 pcs
NOTE: There are 3 kinds of electrode pads in the below table. The electrode
pads here are for customers to choose.
11 Accessories and Parts
12 The Paraphrase of
Graphic Symbol
7)When the apparatus is moved, must be handled with care, avoiding the
shake.
8)The apparatus should be checked the batteries condition, to check
whether the output is good, if has abnormal conditions, you should pay
attention to it and service it in time.
9)The apparatus’ shell board should be pay attention to protection, avoiding
the abrasion.
10)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.
10 11
⑹Do not use the product in the place where is direct sunlight,
high heat, inflammable, electromagnetic radiation and humid.
⑺Do not disassemble, repair and transform the therapeutic
apparatus, otherwise cause failure or get an electric shock
accident.
⑻The 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.
⑼Check the equipment before each use to avoid the exposed
wires caused by accidental damages or other reasons.
⑽Dust may affect the performance of the unit, please use a dry
soft cloth to clean the device as needed.
Please check whether the electrode is loose before each use,
otherwise it may have adverse effects on performance or cause
other problems.
1)Before turn on the main unit, please check whether the battery is charged;
2)If the apparatus runs normally, show key invalidly after press. To turn it off
after a few seconds and then opening, if still not normal, check whether it is
broken for the apparatus;
3)If all operation of the apparatus are normal but without output (the user
without feelings) after turn it on. Please check whether the electrode pads is
directly contacted with skin, the contacting parts whether has hair, clothes
and so on;
4)While cleaning, shutdown first, let the electrode wires stay away from the
electric supply socket. You can wipe by using soft cloth or towel with a little
water and after dry.
5)After each use, please clean electrode pads, you can wipe by using soft
cloth or towel with a little water and after dry, when conducting electrode
pads are particularly dirt, you can wipe by using soft cloth with a little
medicinal alcohol (alcohol concentration as 75%).
6)The apparatus should be placed in the place which is dry, ventilated and
good insulation use.
Model
EPAD
-D01
EPAD
-D02
EPAD
-D03
Drawing Size
Effective area of
single piece (cm2)
Material
70×52mm
50×50mm
50×50mm
Hydrogel
Hydrogel
Hydrogel
33cm2
25cm2
25cm2

The product conforms to the following standards and laws:
1、IEC 60601-1:2005+A1：2012 Medical electrical equipment-Part 1:
General requirements for basic safety and essential performance
2、IEC 60601-1-11：2015 Medical Electrical Equipment - Part 1-11:
General Requirements For Basic Safety And Essential Performance -
Collateral Standard: Requirements For Medical Electrical Equipment And
Medical Electrical Systems Used In The Home Healthcare Environment
3、IEC 60601-2-10：2013 Medical electrical equipment - Part 2-10:
Particular requirements for the safety of nerve and muscle stimulators
4、IEC 60601-1-2:2014 Medical Electrical Equipment - Part 1-2: General
Requirements For Basic Safety And Essential Performance - Collateral
Standard: Electromagnetic Disturbances - Requirements And Tests
The equipment is intended for use in the electromagnetic environment
specified below. The customer or the user of the EQUIPMENT should
assure that it is used in such an environment.
The Transcutaneous Electrical Nerve Stimulators is suitable for
use in a professional health care environment, not including areas where
there are sensitive equipment or sources of intense electromagnetic
disturbances, such as the RF shielded room of an imaging system magnetic
resonance imaging, in operating rooms near active AF surgical equipment,
electrophysiology laboratories, armored rooms or areas where short wave
therapy equipment is used.
●Do not use the system around strong electric filed, electromagnetic filed
(e.g. MRI scan room) and mobile wireless communication devices. Using
the device in an improper environment may cause malfunction or damage.
●The compliance with EMC and EMI regulation cannot be guaranteed by
the use of modified cables or those which does not comply with the same
standards under what the equipment was validated.
13 Executive Standards
Appendix EMC Declaration
Graphic symbol Paraphrase
Product batch number tag
Product serial number tag
Manufacturer
This product only for indoor use
It means prohibition (the thing was not
permitted to do)
It means enforcement (the thing must be
observed)
Keep out of the sun
Contact its local authorities to determine the
proper method of disposal of potentially bio
hazardous parts and accessories.
Keep away from rain
IP22
CE label and noticed body code
This symbol is used to direct the user to refer to
documentation for additional information
regarding the system use or description.
The dustproofing and waterproofing grade, that
is, to prevent the solid object is greater than
12mm to invade, the inclination of 15 degrees
can prevent dripping invasion still not cause
harmful effects.
0413
Production date
Precautions
EU representative
Warning against danger
Applied part of type BF
Class II equipment
12 13

The following tables provide information on compliance
of the equipment according to the standard
EN 60601-1- 2:2015.
Table 1 Compliance class
Emissions
Test
Compliance Electromagnetic Environment and
Guidance
RF emissions
CISPR 11 Group 1
The equipment 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
Harmonic
emissions
IEC 61000-3-2
Class A
Voltage
fluctuations/
flicker
emissions
IEC 61000-3-3
Complies
The equipment 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.
●The system must not be used adjacent or supported by other equipment.
The recommendations of this manual must be followed.
●Do not use accessories, transducers, internal parts of components and
other cables other than those previously specified by the manufacturer. This
may result in increased emission or decreased electromagnetic immunity
and result in improper operation.
●Portable RF communications equipment (including peripherals such as
antenna cables and external antennas) should by used no closer than 30cm
to any part of the ultrasound system, including cables specified by the
manufacturer. Otherwise, degradation of the performance of this equipment
could result.
●To maintain basic safety in relation to electromagnetic disturbances during
the expected service life, always use the system in the specified
electromagnetic environment and follow the maintenance recommendation
described in this manual.
14 15
Table 2- Compliance standards
Phenomenon Basic
Standard of Immunity Test Level of
±8 KV contact
±2 KV, ±4 KV,
±8 KV,±15KV air
±8 KV contact
± 2 K V, ± 4 K V,
± 8 KV, ±15KV air
3V/m
80 MHz-2.7 GHz
80% AM at 1 KHz
3V/m
80 MHz-2.7 GHz
80% AM at 1 KHz
See table See table
±1 KV
100 KHz repetition
frequency
±1 KV
100 KHz repetition
frequency
Electrostatic
discharge
IEC 61000-4-2
Radiated RF
EM fields1
IEC 61000-4-3
Proximity
fields from RF
wireless
communication
equipment
IEC 61000-4-3
Electrical
Fast/Transients
bursts
IEC 61000-4-4
3V
0.15 MHz-80 MHz
6 Vm in ISM bands
between 0 .15 MHz
and 80 MHz
80% AM at 1KHz
3V
0.15 MHz-80 MHz
6 Vm in ISM bands
between 0.15 MHz
and 80 MHz
80% AM at 1KHz
Conducted
disturbances
induced by RF
fields.
IEC 61000-4-6
30 A/m
50 Hz or 60 Hz
30 A/m
50 Hz or 60 Hz
Rated power
frequency
magnetic fields
IEC 61000-4-8

16
Table 3- Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipments
Test Frequency (MHz)
Band (MHz)
Service
Modulation
Maximum Power (W)
Distance (m)
Immunity Test Level (V/m)
385 380-390 TETRA 400 Pulse
modulation 18 Hz
1.8 0.3 27
450 710 745 780 810 870 930
430-470 704-787 800-960
GSM 800/900, TETRA 800 , iDEN 820, CDMA 850, LTE 5 Band
Pulse modulation 18 Hz
LTE 13, 17 Band GMRS 460, FRS 460
FM ±5 KHz deviation 1KHz sine Pulse modulation 217 Hz
2 2
0.3 0.30.2 0.3 0.3
28 28
9
1720 1845 1970
1700- 1990
GSM 1800 , CDMA 1900, GSM 1900, DECT,LTE 1, 3, 4 , 25 Band, UMTS
Pulse modulation 217 Hz
228
2450 2400-
2570
Bluetooth, WLAN 802.1 1 b/g/n, RFID 2450, LTE 7 Band
P u l s e modulation 217 Hz
2 0.3
0.3
28
5240 5500 5785
5100- 5800 WLAN
802.11 a/n
P u l s e modulation 217 Hz
0.2 9
0413
WellKang Ltd (www.CE-marking.eu)
Enterprise Hub, NW Business Complex,1 Beraghmore Road,
Derry, BT48 8SE, Northern Ireland
EC REP
Shenzhen Kentro Medical Electronics Co.,Ltd
2nd Floor, No. 11, Shanzhuang Road, Xikeng Village,
Yuanshan Street, Longgang District, Shenzhen City,
Guangdong Province, China
[Tel]: [phone], [Fax]: [phone]