NURSAL PL-029U Istruzioni per l'uso

Marca: NURSAL

Modello: PL-029U

Tipo: Istruzioni per l'uso

Electronic Pulse Stimulator

(TENS Unit)

Operating Manual

PL-029U Edition V1.0

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

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.

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;

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

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

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

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)

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)

(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

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

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.

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

0.23

0.1

0.38

0.73

1.2

2.3

3.8

7.3

100

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.

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.

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

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

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

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

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

100

Mode 12

10,20,30,40,50,60

12.5-55.5

100

Mode 13

10,20,30,40,50,60

100

Mode 14

10,20,30,40,50,60

100

Mode 15

10,20,30,40,50,60

100

Mode 16

10,20,30,40,50,60

100

Mode 17

10,20,30,40,50,60

100

Mode 18

10,20,30,40,50,60

Combination of the above

100

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

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

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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NURSAL PL-029U Istruzioni per l'uso

Marca: NURSAL

Modello: PL-029U

Tipo: Istruzioni per l'uso

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