JKH Health PL-029K8B User manual

‐1‐
Manual of Electronic Pulse Stimulator
PL-029K8B
Operation Manual
PL-029K8B Edition V1.0

‐2‐
Table of Contents
Introduction......................................................................................................................................3
Indications for Use...........................................................................................................................3
Safety Warning................................................................................................................................ 4
Contraindications.............................................................................................................................4
Warnings..........................................................................................................................................4
Precautions.......................................................................................................................................4
Adverse Reactions........................................................................................................................... 5
Environmental Condition for Transport and Storage...................................................................... 5
Symbols interpretation.....................................................................................................................6
Safety Test Standards...................................................................................................................... 6
Electromagnetic Compatibility and FCC statement........................................................................ 6
Product Specifications................................................................................................................... 11
Setup.............................................................................................................................................. 13
Recommended Use Positions........................................................................................................ 13
Operating Instruction..................................................................................................................... 14
App Aplication...............................................................................................................................17
Cleaning and Maintenance............................................................................................................ 20
Disposals........................................................................................................................................20
Trouble Shooting........................................................................................................................... 21
Contact Information.......................................................................................................................22

-3-
Introduction
Electronic Pulse Stimulator delivers electric pulses generated to the user’s skin through the electrodes.
The portable and compact device has multiple modes of different pulse frequencies, covering
Transcutaneous Electrical Nerve Stimulation (TENS) and Powered Muscle Stimulation (PMS). It
includes operating elements of ON/OFF button, intensity increase/mode selection button, and intensity
decrease/timer selection button, and could be attached and detached to the electrode through the two
snap-on connectors.
Indications for Use
TENS
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist,
back, arm, and leg, due to strain from exercise or normal household and work activities.
It is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain
associated with arthritis.
PMS
To be used for the improvement of muscle tone and firmness, and for strengthening muscles in the
arms, abdomen, legs, and buttocks.
It is also intended to temporarily increase local blood circulation in the lower extremity.

-4-
Safety Warning
Contraindications
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.
Do not use this device on patients whose pain syndromes are undiagnosed.
Warnings
Do not apply stimulation over the patient’s neck because this could cause severe muscle spasms
resulting in closure of the airway, difficulty in breathing, or adverse effects on heart rhythm or blood
pressure.
Do not apply stimulation across the patient’s chest, because the introduction of electrical current into
the chest may cause rhythm disturbances to the patient’s heart, which could be lethal.
Do not apply stimulation over, or in proximity to, cancerous lesions.
Do not apply stimulation when the patient is in the bath or shower.
If you have one of the following conditions, please consult with your physician before purchasing or
using this device.
Acute disease, malignant tumor, infective disease, pregnant, heart disease, high fever, abnormal blood
pressure, lack of skin sensation or an abnormal skin condition, any condition requiring the active
supervision of a physician.
Precautions
Do not use this device while driving.
Do not use this device while sleeping.
Do not use this device in high humidity areas such as a bathroom.
Keep the device away from wet, high temperature and direct-sunlight place.
Keep this device out of reach of children.
Stop using this device at once if you feel pain, discomfort, dizziness or nausea and consult your
physician.
Do not attempt to move the electrode pads while the device is operating.
Do not use the device around the heart, on the head, mouth, pudendum or blemished skin areas.
Do not apply stimulation of this device in the following conditions:
(1) across the chest because the introduction of electrical current into the chest may cause rhythm
disturbances to the heart, which could be lethal;
(2) over painful areas. Please consult with your physician before using this device if you have painful
areas;
(3) over open wounds or rashes, or over swollen, red, infected, or inflamed areas or skin eruptions (e.g.,
phlebitis, thrombophlebitis, varicose veins). Apply stimulation only to normal, intact, clean, healthy
skin;
(4) in the presence of electronic monitoring equipment (e.g., cardiac monitors, ECG alarms). The
electronic Stimulator may not operate properly when the electrical stimulation device is in use;
(5) while operating machinery, or during any activity in which electrical stimulation can put you at risk
of injury;
(6) on children.
Be aware of the following.
(1) to consult with your physician before using this device. The simulation with the device may:
i. cause lethal rhythm disturbances to the heart in susceptible individuals, and,

-5-
ii. disrupt the healing process after a recent surgical procedure;
(2) that the device is not effective for pain of central origin, including headache;
(3) that the device is not a substitute for pain medications and other pain management therapies;
(4) that the device has no curative value;
(5) that the device is a symptomatic treatment and, as such, suppresses the sensation of pain that would
otherwise serve as a protective mechanism;
(6) that the long-term effects of electrical stimulation are unknown;
(7) that the user may experience skin irritation, burns or hypersensitivity due to the electrical
stimulation or electrical conductive medium (gel);
(8) if the user has suspected or diagnosed epilepsy, the user should follow precautions recommended by
his or her physician;
(9) to use caution if the user has a tendency to bleed internally, such as following an injury or fracture;
(10) use caution if stimulation is applied over the menstruating uterus;
(11) use caution if stimulation is applied over areas of skin that lack normal sensation;
(12) stop using the device if the device does not provide pain relief; and,
(13) use this device only with the leads, electrodes, and accessories that the manufacturer recommends.
(14) Do not share the use of the electrode pads with others.
(15) Do not use the device while it’s charging.
(16) The device contains the lithium battery. If overheating of the device occurred during the charging,
stop the charging or operation immediately and report to the distributor/seller.
(17) Dispose of the battery-containing device according to the local, state, or federal laws.
The long-term effects of electrical stimulation are unknown.
Since the effects of stimulation of the brain are unknown, stimulation should not be applied across the
head, and electrodes should not be placed on opposite sides of the head.
The safety of electrical stimulation during pregnancy has not been established.
Some patients may experience skin irritation or hypersensitivity due to the electrical stimulation or
electrical conductive medium (gel).
Patients with suspected or diagnosed heart disease should follow precautions recommended by their
physicians.
Patients with suspected or diagnosed epilepsy should follow precautions recommended by their
physicians.
Use caution if stimulation is applied over the menstruating or pregnant uterus.
Adverse Reactions
Patients may experience skin irritation and burns beneath the stimulation electrodes applied to the skin;
Patients may experience headache and other painful sensations during or following the application of
electrical stimulation near the eyes and to the head and face.
Patients should stop using the device and should consult with their physicians if they experience
adverse reactions from the device.
Environmental condition for transport and storage
Normal working ambient temperature: 10~40°C
Normal working ambient humidity: 30~80%
Store and transport ambient temperature: -10 ~50°C
Store and transport ambient humidity: 30~90%

-6-
Symbols interpretation
The Electronic Pulse Stimulator is compliant with:
Medical Devices Directive 93/42/EEC
IEC 60601-1:2005+A1:2012/EN 60601-1:2006 Medical electrical equipment - Part 1: General
requirements for basic safety and essential performance
IEC 60601-1-2:2007/EN 60601-1-2:2007 Medical electrical equipment - Part 1-2: General
requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and
tests
IEC 60601-2-10:2012/EN 60601-2-10:2000+A1:2001 Medical electrical equipment - Part 2-10:
Particular requirements for the safety of nerve and muscle simulators
Electromagnetic Compatibility and FCC Compliance Statement
(1) This product needs special precautions regarding electromagnetic compatibility (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 radio frequency (RF) communications equipment.
(2) 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.
(3) Caution: This unit has been thoroughly tested and inspected to assure proper performance and
Fragile, handle with care Type BF applied part
Keep the product in the dry
place
Away from water and rain.
CAUTION, Avoid injury.
Read and understand
owner’s manual before
operating this product.
This way up Manufacturer
Product package should be
recycled.
Symbol for "AUTHORISED
REPRESENTATIVE IN
THE EUROPEAN
COMMUNITY"
Unrecyclable
CE marking, Certificate
issued by SGS.
Date of manufacture FDA register
Serial number IP22 IP code of the device
Batch code

-7-
operation!
(4) 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
Guidance and manufacturer’s declaration – electromagnetic emission
The device is intended for use in the electromagnetic environment specified below. The customer
of the user of the device should assure that it is used in such an environment.
Emission test Compliance Electromagnetic environment – guidance
RF emissions
CISPR 11 Group 1
The device 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 device 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

-8-
Guidance and manufacturer’s declaration – electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below. The customer
or the user of the device 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
±1 kV for
input/output 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)
± 2 kV line(s) to
earth
±1 kV differential
mode
Mains power quality should be
that of a typical commercial or
hospital environment.
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
<5% UT
(>95% dip in UT)
for 0.5 cycle
40% UT
(60% dip in UT)
for 5 cycles
70% UT
(30% dip in UT)
for 25 cycles
<5% UT
(>95% dip in UT)
fo
r
5sec
<5% UT
(>95% dip in UT)
for 0.5 cycle
40% UT
(60% dip in UT)
for 5 cycles
70% UT
(30% dip in UT)
for 25 cycles
<5% UT
(>95% dip in UT)
fo
r
5sec
Mains power quality should be
that of a typical commercial or
hospital environment. If the
user of the device requires
continued operation during
power mains interruptions, it is
recommended that the device
be powered from an
uninterruptible power supply
or a battery.
Power frequency
(50Hz/60Hz)
magnetic field IEC
61000-4-8
3 A/m 3 A/m Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.
NOTE UTis the a.c. mains voltage prior to application of the test level.

-9-
Guidance and manufacturer’s declaration – electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below. The customer
or the user of the device 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
3V
rms
150 kHz to 80
MHz
3Vrms
Portable and mobile RF communications
equipment should be used no closer to any part
of the device, including cables, than the
recommended separation distance calculated
from the equation applicable to the frequency of
the transmitter.
Recommended separation distance
Where Pis the maximum output power rating of
the transmitter in watts (W) according to the
transmitter manufacturer and dis the
recommended separation distance in metres (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
3V/m
80 MHz to 2.5
GHz 3V/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.
a 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 device is used exceeds the applicable RF compliance level
above, the device should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as re-orienting or relocating the device.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

-10-
The subject device has been tested and found to comply with the limits for a Class B digital device,
pursuant to part 15 of the FCC rules. These limits are designed to provide reasonable protection against
harmful interference in a residential installation.
The product generates, uses, and can radiate radio frequency energy and, if not installed and used
accordance with the instructions, may cause harmful interference to radio communications.
However, there is no guarantee that the interference will not occur in a particular installation. If the
product does cause harmful interference to radio or television reception, which can be determined by
turning the product on or off, the user is encouraged to try to correct the interference by one or more of
the following measures:
a) Reorient or relocate the receiving antenna;
b) Increase the separation between the product and the receiver;
c) Consult the dealer or an experienced radio / TV technician for help.
d) Connect the equipment into an outlet on a circuit different from that to which the receiver is
connected.
Changes or modifications to this product not expressly approved by the party responsible for
compliance could void the user’s authority to operate the equipment.
RF warning statement:
The device has been evaluated to meet general RF exposure requirement. The device can be used in
portable exposure condition without restriction.

-11-
Product Specifications
Accessories included in the package.
(1).Accessories included in the package.
(2).Tens unit controller * 1pc
(3).Large, medium, small gel pads * 3pcs
(4).4*4 cm gel pads * 4pcs
(5).USB line *1pc
(6).Output wire * 1pc
(7).Storage bag * 1pc
Controller introduction
Technical Information
Device name Electronica pulse
stimulator
Dimensions 35*68*11.5mm
Model/type PL-029K8B Weight 19g
Power
supply
Powered by internal3.7V
li-ion battery
Automatic shutoff 30 minutes
Waveform
and wave
shape
Biphasic rectangular
wave pulse
Degree of protection
against electric shock
Type BF applied part
Pulse
duration
50-500us (Microseconds) Type of protection against
electric shock
Internally powered
equipment

-12-
Product Programs
Program name Time min. Frequency (Hz) Pulse Width (μs)
Mode 1 10,20,30,40,50,60,120,540 62.5，12.5-55.5，1.2，100，100，
20,160 100
Mode 2 10,20,30,40,50,60,120,540 62.5 100
Mode 3 10,20,30,40,50,60,120,540 12.5-55.5 100
Mode 4 10,20,30,40,50,60,120,540 1.2 100
Mode 5 10,20,30,40,50,60,120,540 100 100
Mode 6 10,20,30,40,50,60,120,540 100 100
Mode 7 10,20,30,40,50,60,120,540 20 100
Mode 8 10,20,30,40,50,60,120,540 160 100
Pulse
frequency
1-500 Hz (Hz=vibration
per second)
Grade of waterproof IP22
Output
Voltage
Max. 80Vpp ±20%(at
500ohm load) Product life 1 year
Treatment
time
10 min, 20 min, 30 min,
40 min, 50 min, 60 min,90
min, 120 min,540 min
Lifetime for electrode Storage for 1 year（no
use）, Times of reusable:
30 times
Output
intensity
0 to 100 levels, adjustable Mode of operation Continuous operation
Modes 8 auto modes and 1
manual mode
Software version A0
Note: Not intended to be sterilized.
Not for use in an OXYGEN RICH ENVIRONMENT

-13-
Setup
Unpack the box of the product, take the product and accessories out, and connect the electrode pad onto
the device. There are large, medium, and small size gel pads suitable for different body position. For
example, large size gel pad is suitable for back and waist, medium size gel pad for shoulder and neck,
the small size gel pad for joints. If you’d like to use the gel pad on a small and specific body position,
you can use the 4*4CM gel pads and you need to connect the gel pad with the controller by the output
wire with four snappers.
Recommended Use Positions

-14-
Operating instruction
The following steps are used to guide the device operation, and the details about each step are listed in
the following table.
1st Step – Check the battery power for the Electronic Pulse
Stimulator
Battery charging
The Electronic Pulse Stimulator comes with a built-in
rechargeable battery, and could be used as received. If the
control unit has a flashing LED light when turned on, it
means the battery is running out of power. Turn off and
charge the control unit with the enclosed USB cable. The
LED light is flashing during charging, and becomes solid
when the control unit is charged fully.
2nd Step - Install the electrode pad onto the Electronic
Pulse Stimulator
Electrode pad installment
The electrode pad has two snap-on male connectors, and
the Electronic Pulse Stimulator has two snap-on female
connectors on its back side. Snap the enclosed electrode
pad onto the Electronic Pulse Stimulator through the snap-
on connectors. This should be done prior to applying the
device onto the skin of treatment areas.
3rd Step - Put the electrode pad-installed Stimulator on the
stimulation-needed body area
Place the device on the body area
Place the pad-installed device onto the treatment areas
(such as shoulder and leg). Press down firmly and ensure a
full and firm contact with skin.
Note: Keep the skin clean before placing the pads
4th Step - Press the “ON/OFF” to turn on the power
Press the On/Off button to turn on the unit.
5th Step - Select one of the stimulation modes
Change the output stimulation modes by pressing the +
button for 3 seconds.
6th Step - Choose the stimulation time

-15-
Press the - button for 3 seconds to change the stimulation
time.
7th Step - Adjust the stimulation intensity
Intensity selection
Press and release the “+” button to increase the stimulation
intensity, and press and release the “-” button to decrease
the intensity.
Note: With the increase of intensity, you may experience
sensations like tingling, vibration, etc. Therefore, gradually
increase the intensity, and stop increasing when a
comfortable level is reached.
8th Step - Stay with the stimulation
Stay with the stimulation
Enjoy the stimulation provided by the device, after the
above mode, time, and intensity were set up.
9th Step - Press the “ON/OFF” to turn off the power after
done
When the timer is up, the device will turn off
automatically. The device could be also turned off by
pressing the On/Off button.
Note: When not in use, store the device and accessory in a
cool place, out of direct sunlight.
As shown in the above device operation, the biocompatible electrode, consisting of electrode gel,
carbon film, backing material, and snap-on connectors, is used with the device as the accessory. Please
see the following for the Use Directions, Removal, and Storage for the electrode.
Directions for Use
Clean skin thoroughly prior to each application of electrodes, which will not stic
k
well if any lotion,
make-up, or dirt is left on the body skin.
Turn the Electronic Pulse Stimulator off
b
efore applying the electrode to the
b
ody skin.
Install the pad included onto the back side of the Electronic Pulse Stimulator.
Apply the pad-installed device firmly to the skin.
To choose suitable size gel pad fo
r
different
b
ody position.
Removal and Storage
Turn the device off
b
efore removing the electrode from the
b
ody skin.

-16-
Lift at the edge of the electrode and peel.
When not in use, store the electrode in the re-sealable
b
ag in a cool place, out of direct sunlight an
d
dirty.
Recommended practice:
Duration suggeste
d
fo
r
each skin area is 20 min and 2 times per day. Consult with you
r
physician
for longer and more frequent uses.
Start from the lowest intensity and gradually adjust the intensity to a comfortable level at a scale
from 1 to 100.
Good skin care is important for a comfortable use of device. Be sure the treatment site is clean of
dirt and body lotion.
Keeping the electrode in the storage bag after use will extend its lifespan. The electrode is
disposable and should be replaced when it loses the adhesiveness. To purchase additional electrodes,
please contact the seller.

-17-
APP application
Download the APP.
(1). Make sure your smart phone is above Bluetooth 4.0 version. This APP can only be applied to the
phone with Bluetooth version above 4.0.
(2).When you search “TENS+EMS” in the App Store and Google Play, you will find the APP icon as
below, download it and install it to your phone.
If the optional accessory of the phone application interface was provided, the Quick Response (QR)
code would be included in the packaging. The user could directly use the remote and/or just scan the
code fo
r
automatic installation.
(3). After the App is installed, the icon will sho
w
on the phone.
Introduction of the APP
Application interface
Use the APP
(1).Manual has to be read before using the APP. Make sure you have understood all the warnings.
(2).Snap the gel pad on the controller and turn the TENS unit on before open the APP.
Icon on the Phone
Application Interface Indication
Timer icon to change the countdown timer
Icon to stop and exit the operation of the device
Icon for useful information, such as warnings
Intensity bar to increase and decrease the
intensity
Mode icon to select one of the modes displayed
on the LCD
Icon to pause and resume the operation of the
device

-18-
(3).Click the App icon to open the App, you will be reminded to open Bluetooth first.
Once the blue tooth is opened, the app will automatically connect to the TENS unit which has been
turned on. The Tens unit controller will make buzz after successfully connected with the APP.
Note: If the App did not connected automatically, please click the upper right corner to access the
BLUETOOTH section to scan the TENS unit for the connection. Click “Connect”as below.
(4). Slightly sliding the intensity
b
ar on the phone application interface coul
d
increase the
intensity of the Electronic Pulse Stimulator, and sliding the intensity
b
ar in the othe
r
direction coul
d
decrease the intensity. The corresponding intensity will display on the
App interface. An
d
the user will feel the stimulation on the treatment
b
ody area.
Remembe
r
always increase the intensity
b
ar very slightly.
(5).The initial mode is auto mode 1, if you’d like to change to other modes, press ,
there will be 8 modes for selection. Remember every time you change one mode to
another mode,the intensity will start from level 0, you have to increase the intensity for
the new selected mode. This design aims not to make people feel shocked when they
change to a new mode.
(6).If you are interested to try more modes, you can use the manual modes by setting
different frequencies, pulse widths, continuous and intervals, there will be more modes
to be created. You can find the one you like. Or you can consult your physician what is
the best setting for you.
(7).Click the SETTINGS in the upper ri
g
ht corne
r
of the main App
interface to view the relate
d
information, such as Warnin
g
s, Intende
d
Use,
and Bod
y
Area Applied, and chan
g
e the parameters, such as Timer, Auto
Mode, an
d
Manual Mode. B
y
clickin
g
the icon on the phone
application interface coul
d
pause the device; click it again to resume.

-19-
(8). The following information could be viewed when the user
clicks Warnings, Intended Use, and Body Area Applied,
respectively.
(9). The recorded pulse mode, Intensity, and Time could be viewed when the user click
“Data Record”.
(10). The Bluetooth page will display the TENS device connected to the App.
(11). When done, turn off the Electronic Pulse Stimulator and exit the phone
application interface, and put them away for the next use.
Note: In addition to using the App to control the TENS device, the device could be operated
independently and also control the App, as follows.
Press and release the +
b
utton to increase the intensity
Press and release the - button to decrease the intensity
Hold the + button to change the mode
Hold the - button to change the timer
Hol
d
b
oth the + and -
b
uttons to pause/resume the device.
Note: It is suggested to use the wireless control in an operating distance of 3 meters with the device. At
any distance and time, you could switch to operate the device itself independently to deal with any risks
and problems that may arise.

-20-
Cleaning and maintenance
Please use the moisturized cloth of water or neutral detergent to clean the device first, and then use the
dry cloth to wipe it again. The electrode pads coming with the device are disposable, and should be
replaced when their adhesiveness becomes worse. Contact the seller for replacements. Do not let the
sticky side of the pad touch anything, including the greasy finger tips.
Disposal
You will find these markings on batteries containing harmful substances: Pb= battery containing lead,
Cd= battery containing cadmium, Hg = battery containing mercury. Please dispose of the device in
accordance with the directive 2002 / 96 / EC–WEEE (Waste Electrical and Electronic Equipment). If
you have any queries, please refer to the local authorities responsible for waste disposal.
N
OTE: You will fin
d
these markings on
b
atteries containing
harmful substances: Pb=battery containing lead, C
d
=
b
attery. containing cadmium, Hg
=
b
attery containing mercury.
Disposal of battery
Spent
b
atteries do not
b
elong in the household waste. Dispose of the
b
attery according to the current
regulations. As a consumer, you are obligated
by
law to return spent
b
attery to the Recycle Bin.
Please dispose of the device in accordance with the directive 2002/96/EC – WEEE (Waste Electrical
and Electronic Equipment). If you have any queries, please refer to the local authorities responsible for
waste disposal.