Table of Contents
Introduction....................................................................................................................................................1
Indications for Use.........................................................................................................................................1
Safety Warning.............................................................................................................................................. 2
Contraindications...........................................................................................................................................2
Warnings........................................................................................................................................................2
Precautions.....................................................................................................................................................2
Adverse Reactions......................................................................................................................................... 4
Environmental Condition for Transport and Storage.....................................................................................4
Symbols interpretation...................................................................................................................................5
Safety Test Standards.....................................................................................................................................5
Electromagnetic Compatibility and FCC Compliance statement................................................................ 6
Product Specifications................................................................................................................................. 12
Setup............................................................................................................................................................ 15
Operating Instruction................................................................................................................................... 16
Recommended practice................................................................................................................................17
Cleaning and Maintenance...........................................................................................................................18
Trouble Shooting......................................................................................................................................... 19
Recommended Use Positions.......................................................................................................................20
Contact Information.....................................................................................................................................21
Électrostimulateur (Appareil TENS)........................................................................................................... 22
Elektronischer Pulsstimulator (TENS Gerät)...............................................................................................27
Stimolatore Elettronico a Impulsi (Unità TENS).........................................................................................31
Estimulador eléctrico transcutáneo (Unidad de TENS)...............................................................................36
Contents of Different Language Versions
English......................................................................................................................................................1-21
French.....................................................................................................................................................22-36
German................................................................................................................................................... 27-30
Italian......................................................................................................................................................31-35
Spanish....................................................................................................................................................36-40
1
Introduction
Electronic Pulse Stimulator（TENS）delivers electric impulses to tired and sore muscles. These
different frequencies of impulses covering Transcutaneous Electrical Nerve Stimulation mimic the
action potential coming from the central nervous system to trigger contraction of the muscle. It may be
helpful in relieving aches and pains in various parts of the body such as the waist, shoulders, joints,
hands and feet.
Indications for Use
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.
2
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.,
3
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;
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;
(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 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
4
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 normal working, transport and storage
- Normal working ambient temperature: 5~40°C
- Normal working ambient humidity: 15%~90% RH
- Store and transport ambient temperature: -25 ~70°C
- Store and transport ambient humidity: 0%~90% RH
- Atmospheric pressure: 70~106kPa
5
Symbols interpretation
Safety Test Standards:
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 stimulators
IEC 60601-1-11:2010 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.
EN 980 Symbols for use in the labeling of medical devices
EN 1041 Information supplied by the manufacturer with medical devices
IEC/60601-1-6/ EN 60601-1-6 Medical electrical equipment – Part1-6: General requirements for
basic safety and essential performance – Collateral standard: Usability
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
Batch code
Date of manufacture
FDA
510(k)
FDA 510(k) cleared
Serial number
IP22
IP code of the device
6
IEC 60601-1-11/ EN 60601-1-11 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 home healthcare environment
IEC 62304/ EN 62304 Medical device software - Software life-cycle processes
IEC 62366/ EN 62366 Medical devices – Application of usability engineering to medical devices
ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk
management process
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
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 manufacture’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 use 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
Not applicable
(internal battery powered)
7
Guidance and manufacture’s declaration – electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below. The customer or the user of 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
Not applicable
(internal battery
powered)
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
Not applicable
(internal battery
powered)
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
Not applicable
(internal battery
powered)
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.
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Not applicable
(internal battery powered)
8
(30% dip in UT)
for 25 cycles
<5% UT
(>95% dip in UT)
for 5 sec
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.
Guidance and manufacture’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
3 Vrms
150 kHz to 80 MHz
3 Vrms
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
9
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,ashould 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
3 V/m
80 MHz to 2.5 GHz
3 V/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.
Recommended separation distances between
portable and mobile RF communications equipment and the device .
The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the
user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the device as recommended below, according to the maximum output power of the
communications equipment.
10
Rated maximum output power
of transmitter
(W)
Separation distance according to frequency of transmitter
(m)
150 KHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2.5 GHz
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended separation distance din metres (m) can be
estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for 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.
11
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.
12
Product Specifications
Accessories included in the package.
(1).Tens unit controller * 1pc
(2).Large gel pad*2pcs; palm shape gel pad*4pcs; small gel pads * 2pcs
(3).Output wire * 3pcs
(4).USB line *1pc
(5).Gel pad collector * 1pc
(6).Manual *1pc
(7).Collecting bag*1pc
Technical Information
Model/type
PL-029U
Weight
110g
Power supply
Powered by internal 3.7V li-ion
battery
Automatic shutoff
20 minutes
Waveform and
wave shape
Biphasic rectangular wave pulse
Degree of protection
against electric shock
Type BF applied part
Pulse duration
100us (Microseconds)
Type of protection
against electric shock
Internally powered
equipment
Pulse frequency
1-100Hz (Hz=vibration per
second)
Grade of waterproof
IP22
Output Voltage
Max. 50pp ±20%(at 500ohm load)
Product life
1 year
Treatment time
10.20,30,40,50,60minutes
Lifetime for electrode
Storage for 2 year
（no use）, Times
of reusable: 30 times
Output intensity
0 to 20 levels, adjustable
Mode of operation
Continuous
operation
Modes
18 auto modes
Software version
A0
Typical
operation time of
Battery
If to use both channels at level 20,
the battery can be used for
about180 minutes after fully
charged.
The time required for me
equipment to warm from
the minimum storage
temperature between uses
until it is ready for
30 minutes
13
intended use
Behaviour of me
equipment while
the rechargeable
internal electrical
power source is
charging:
The battery icon on the right
corner will flash during charging
and will be still with full capacity
after fully charged.
The time required for me
equipment to cool from
the maximum storage
temperature between uses
until it is ready for
intended use
15 minutes
Typical service
life of Battery
300 times of recharging
Adapter for charging
Please use output
DC5V and output
current 0.3-2.0A
adapter for charging
Note: Not intended to be sterilized.
Not for use in an OXYGEN RICH ENVIRONMENT
14
Programs
Program name
Time min.
Frequency (Hz)
Pulse Width (μs)
Mode 1
10,20,30,40,50,60
10-35
100
Mode 2
10,20,30,40,50,60
8.75-60
100
Mode 3
10,20,30,40,50,60
4-100
100
Mode 4
10,20,30,40,50,60
18-100
100
Mode 5
10,20,30,40,50,60
18-52.5
100
Mode 6
10,20,30,40,50,60
1-100
100
Mode 7
10,20,30,40,50,60
1-35
100
Mode 8
10,20,30,40,50,60
6.6-10
100
Mode 9
10,20,30,40,50,60
4-8
100
Mode 10
10,20,30,40,50,60
62.5
100
Mode 11
10,20,30,40,50,60
2
100
Mode 12
10,20,30,40,50,60
12.5-55.5
100
Mode 13
10,20,30,40,50,60
100
100
Mode 14
10,20,30,40,50,60
80
100
Mode 15
10,20,30,40,50,60
50
100
Mode 16
10,20,30,40,50,60
6
100
Mode 17
10,20,30,40,50,60
30
100
Mode 18
10,20,30,40,50,60
Combination of the above
100
15
Setup
Unpack the box of the product, take the product and accessories out, and snap the connect unit onto the
electrode pad.
ON/OFF/Screen lock
Intensity Increase
Countdown Timer
Battery Indicator
LCD Display
Intensity Decrease
Intensity Indication
A/B Channel
Output A Channel
USB Port
Output B Channel
Pause
Intensity Increase
Intensity Decrease
Cycle Function
Screen lock
16
Operating instruction
The following steps are used to guide the device operation.
Electronic Pulse Stimulator (TENS) needs to be charged for up to 8 hours before the first use.
Connect a pair of electrode pads to one connecting wire by snapping them on; the other end of the
connecting wire is connected to the left output of the device. Similarly, the other pair of electrode
pads is connected to the remaining connecting wire and the right output of the device.
Attach one pair or two pair of the electrode pads to the treatment area, such as shoulder and legs.
Press the ON/OFF button for 2 seconds to turn the unit on, the unit will automatically start at Mode
1 and Channel A.
Lightly touching the screen to change mode as your like, make sure not change the mode too fast.
Before changing intensity of mode, firstly you should know which channel you are at. Since the
intensity changing of channel A and channel B is separate. If icon A is flashing, you are can
change the intensity of channel A only. If icon B is flashing, you can change the intensity of
channel B only.
If you want to change from channel A from channel B, you can press the button A/B once or you
can just simply press A or B icon on the two sides of intensity bars at bottom of the screen to
change the channel.
When certain mode has been chosen, you can change the intensity of this mode. The icon A will be
flashing, you can change the intensity of channel A now. If you want to change the intensity of
channel B, press the button A/B once or you can just simply press A or B icon, then the icon B is
flashing, now you can change the intensity of channel B only.
There are two ways to change the intensity, you can touch the icon +on the screen OR pressing the
+button on the right side of uni to increase the intensity. By touching the icon- on the screen or
press the - button on the right side of the unit, you can decrease the intensity.
When pressing the SUSPEND button, the unit will pause and there is not output till you press the
button SUSPEND again. In SUSPEND status, the intensity, mode, timer etc are not adjustable. But
the screen lock function is available.
If you like certain mode and you want to keep using it, you can simply press the cycle
icon on top of the screen, then the current mode and intensity will keep on till you stop
the cycle function by pressing the cycle icon again. The default cycle countdown time is 20
minutes, the cycle function will make the countdown time repeat again and again. You can also
reset the countdown time by yourself.
If you enjoy certain mode and don’t want to make any change further, you can press the ON/OFF
button once slightly, the screen will be locked and the backlight is off in order to save more energy,
Or press the lock icon on the screen, the screen will be locked but the backlight is still on. In
locking status, the unit is till on with intensity output but all function icons are locked, you are not
17
able to change the mode, intensity etc. It will avoid screen touching by mistake. To unlock the
screen, you can press the ON/OFF once slightly or press the lock icon on the screen.
Pressing the countdown time on the screen, you can set the timer from 10 minutes to 60 minutes.
When power bar in the battery icon disappear, the unit is going to run out power, it should be
charged as soon.
When you turn on the unit, if the unit test no load, for example you didn’t connect the unit well
with body, you are not able to adjust the intensity.
Recommended practice:
Duration suggested for each skin area is 20 min and 2 times per day. Consult with your 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 20.
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.
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in altre lingue
- English: NURSAL PL-029U Operating instructions
- français: NURSAL PL-029U Mode d'emploi
- español: NURSAL PL-029U Instrucciones de operación
- Deutsch: NURSAL PL-029U Bedienungsanleitung
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PAINGONE 15229690 Istruzioni per l'uso
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Beurer S02961 Istruzioni per l'uso
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Compex Back Wrap for Pain Relief Manuale utente
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Compex FIT Manuale utente
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Philips PR3098/12 Manuale utente
-
Compex RUNNER Manuale utente
