PAINGONE 15229690 Istruzioni per l'uso

Read carefully before using

this device

Model No. KTR-2302

*pain relief is temporary

User Manual

EN

freedom from period pain

2

Table of Contents

The serious stuff

Indications for Use and Intended User 3

Who should NOT use Ellune – Contraindications 3

Warnings and Cautions 4

Contents of your Ellune pack 6

Device overview and diagrams 8

Everything you need to know about using Ellune

Before using for the first time 9

Device set-up 9

Positioning the electrodes 10

Applying the electrodes 10

Connecting the electrodes to Ellune 10

Using Ellune 10

Lock function 11

Connection error 11

Finishing a session 11

Taking care of your Ellune

Replacing the gel pads 12

Charging your Ellune 12

Cleaning and Maintenance 12

Frequently Asked Questions 13

Troubleshooting 14

Technical Details

Device Specification 15

Glossary of Graphic symbols 16

Safety and compliance standards 17

EMC & Electrical standards/requirements 17

Electromagnetic emissions tables 19

Device lifespan 22

Manufacturer and EC rep details 22

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The serious stuff

Indications for use

Ellune is a TENS device for the temporary relief of menstrual pain and

discomfort for primary dysmenorrhea, when the pain associated with

menstruation is not caused by any underlying gynaecological disorder

Intended user

Ellune should be used only by those aged 16 and above, that are still having

menstrual periods.

Who should NOT use Ellune?

CONTRAINDICATIONS

DO NOT USE:

eIf you have suspected or confirmed epilepsy or heart disease,

malignant tumour, serious cerebrovascular disease or other acute

disease, unless specialist medical authorisation has first

been obtained.

eIf you are fitted with a pacemaker or other active implanted electrical

device. Such use could cause electric shock, burns, electrical

interference, or death.

eIn case of epilepsy or suspicion of epilepsy because electro

stimulation could promote the occurrence of epileptic seizures.

eThis device is not intended for and should not be used by those who

are pregnant, in labour, or breastfeeding.

eEllune should not be used while fertility problems are being evaluated,

diagnosed, or treated.

eDo not use in areas with staples, implants or any metal parts in order

to avoid the risk of burns or pain.

eOn children or people with no ability to express their

own consciousness.

eIf you have been diagnosed with or have any reason to believe that you

may be suffering from, Deep Vein Thrombosis (“DVT”).

eIf suffering from haemorrhage after acute trauma or fractures, or if

recovering from surgery.

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ADVERSE REACTIONS

eUse of the device may cause irritation to the skin beneath

the electrodes.

eBurns beneath the electrodes have also been reported in

the literature.

eApplication of electrodes near the thorax may increase the risk of

cardiac fibrillation.

eAllergic reactions to the gel adhesive may be possible.

eLong-term stimulation of the same area may cause skin irritation.

WARNINGS

eDo not place electrodes over the neck because this could cause severe

muscle spasms resulting in closure of the airway, difficulty breathing,

or adverse effects on heart rhythm or blood pressure.

eDo not place electrodes across the chest because the introduction of

electrical current into the chest may cause rhythm disturbances to the

heart which could be lethal.

eDo not place electrodes over open wounds, rashes, or over swollen,

red, infected, or inflamed areas or skin eruptions (e.g., phlebitis,

thrombophlebitis, and varicose veins).

eDo not place electrodes over, or in proximity to, cancerous lesions.

eDo not place electrodes on the genitals.

eElectrodes should be applied only to normal, intact, clean and

healthy skin.

eIncorrect application of electrodes could result in discomfort or

burning of the skin.

eDo not share electrodes with other persons because of the risks of

adverse skin reactions and disease transmission.

eAs Ellune is a TENS device, it is intended for symptomatic treatment

and has no curative effect.

eElectronic devices (such as an ECG and others) may not operate

properly when TENS stimulation is in progress.

CAUTION:

eTurn Ellune off before applying or removing the electrodes.

eTENS is not recommended for patients with heart disease who have

not received a medical evaluation of possible adverse effects.

eTENS should not be used to alleviate an undiagnosed pain syndrome

until the etiology has been well established.

eEllune should not be used for ovulation pain (mid-cycle pain).

eEllune should not be used while fertility problems are being evaluated,

diagnosed, or treated.

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eEllune should not be used during pregnancy, labour or breastfeeding.

eBatteries are rechargeable; batteries should not be replaced by

unauthorised personnel.

eTo avoid cross-contamination, electrodes are intended to be used by

one person only.

eTo avoid potential contamination, use the electrodes only on intact skin

for no longer than 10 hours at a time.

eKeep Ellune dry. Do not expose the device to a wet environment and do

not use when bathing or showering.

CAUTIONS

eUse caution while using Ellune in tandem with any monitoring

equipment with body-worn electrode pads. Ellune may interfere with

the signals being monitored.

eStrong electromagnetic fields may affect the correct operation of

this device. If unusual phenomena are observed, move away from

electromagnetic fields.

eUse caution following recent surgical procedures. Electrical

stimulation may disrupt the healing process.

eSince the effects of stimulation of the brain are unknown, stimulation

electrodes should not be placed on opposite sides of the head.

eThe long-term effects of cutaneous electrodes for electrical

stimulation on the human body are unknown.

eKeep electrodes out of the reach of children.

eUse caution if electrodes are applied over areas of skin that lack

normal sensation.

eReplace self-adhesive electrodes if they no longer stick firmly to

the skin.

eDo not charge the device while using it.

eDo not operate the device when electrodes are not connected. Make

sure the device is off before removing or connecting the electrodes.

eUse caution, if operating machinery or driving, to ensure that electrical

stimulation or involuntary muscle contraction is not dangerous.

eDo not use this device while you sleep to avoid the risk of pain,

inflammation, or burns due to excessive intensity adjustment that you

would not be able to control for lack of alertness.

Do not place electrodes:

eOn broken skin.

eOn skin which does not have normal sensation. If the skin is numb, too

great a strength may be used in the Ellune and this could result in

skin inflammation.

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eOn the front of the neck. Doing so could cause the airway to close,

affecting breathing, or causing a sudden drop in blood pressure

(vasovagal response).

eOver the eyes. Doing so may affect eyesight or cause headaches.

eAcross the front of the head. The effect on patients who have had

strokes or seizures is unknown.

eOver, or in proximity to, cancerous lesions.

Do not:

eIgnore any allergic reaction to the electrodes. If skin irritation

develops, stop using the device.

eImmerse your device unit in water or place it close to excessive

heat – this may cause the device to cease operating correctly.

eAttempt to open up the device - there are no serviceable components

and there is a risk of electric shock.

eUse this device with electrodes other than those recommended by the

manufacturer – performance and safety may be compromised.

Contents of your Ellune pack

Silicone cover

This fits over your Ellune. Different

colours are available allowing you

to customise your device.

Charging cable

Lets you connect your Ellune to a

USB point to charge the battery

Ellune device

The main unit that lets you control

the therapy.

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2x electrode pads

These pads are placed on your skin,

at the point of pain, where they

deliver Ellune’s therapy. They are

connected by cable to the

Ellune unit.

Connecting cable

Connects the electrode pads to the

Ellune device.

Carry bag

Keep Ellune and its accessories in this bag

for protection and easy transport.

www.paingone.com

6x gel pads

These replaceable gel pads

help the electrode pads

adhere to your skin.

If any part is missing, or to purchase accessories for your

Ellune, contact your local distributor or visit

User manual

The manual you have in your hands right now!

Quick start guide

8

Device overview and diagrams

Device front view

Reverse view Electrode pads

Side view

Display screen

ePower On/Off button

eIncrease Intensity button

eDecrease Intensity button

eLock function button

eDisplay screen

eConnecting Cable

eElectrode Pad

eAttaching clip – Allows you to

attach Ellune to your waistband

eUSB-C Connection point

eBattery level

eConnection

error indicator

eLock function

indicator eIntensity level

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Everything you need to

know about using Ellune

Before using for the first time

We recommend charging your Ellune before using

for the first time. This will give your device the best

possible start and ensure it performs optimally.

1. Connect the charging cable to Ellune

2. Connect the cable to a USB charger

3. We recommend charging for 2 hours this first time.

All future charges take approximately 1 hour.

Device Set-up

1. Take the electrode pads.

2. Attach the first pad to the

connecting cable. The pads

connect via metal press studs.

Press until the connection snaps

firmly into place.

3. Repeat this action with the

second pad.

4. Take a gel pad. Remove a plastic

liner from one side of the pad (be

sure to retain liners for later)

5. Apply the gel pad to the reverse

(the black side) of on

electrode pad.

6. Repeat the above with the

second gel pad, applying it to the

second electrode pad.

connect

Scan the QR

code to watch a

‘how-to’ video

6

1

2

3

4

5

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Positioning the electrode pads

In the next step we will apply the pads

to the required area. You can apply them

on the abdomen or the lower back,

depending on where you have the

most pain.

Aim to position the pads on either side

of the painful area, at the same height,

and at a distance of 5-10cm apart from

each other.

Using Ellune

1. Press the power button to

activate Ellune.

2. Set the intensity to a level you

find comfortable. Use the “+”

button to increase the intensity.

You can tap it to increase by just

one level. Or hold the button

down to change levels rapidly.

If the intensity becomes too

strong, press the “-“ button to

reduce intensity.

3. The screen displays your

chosen intensity level. There

are 35 levels in total.

+

+++

Connecting the pads to Ellune

1. Now, take the connecting cable and connect this to your Ellune device.

Applying the electrode pads

1. Ensure that your desired area of application is clean and dry.

2. Remove the remaining plastic liners from the gel pads.

3. Apply the pads as required on the abdomen or lower back.

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Lock function

To avoid accidentally changing the intensity

or turning the device off during use, press the

‘lock’ button to activate lock mode. This will

disable all the other buttons. Simply press the

‘lock’ button once more to exit lock mode.

Connection error

If Ellune detects that there is a connection

error, it will pause therapy and display the connection

error symbol on the display screen.

To resolve a connection error, check that:

- The gel pads are applied firmly to your skin

- The connecting cable is correctly attached to the pads and Ellune device

Once connection is re-established, Ellune will automatically resume therapy

and return to the intensity level that was previously selected.

Over time, the connecting cable and/or electrode pads may deteriorate

from daily wear and tear. These parts can be replaced. Contact your local

distributor or visit www.paingone.com for replacements.

Finishing a session

1. To stop the Ellune therapy, simply press the power button.

2. Carefully remove the pads from your skin.

3. Place a plastic liner back over each gel pad. This will keep them in

optimum condition for their next use.

4. You can store Ellune and its accessories in the carry bag supplied.

4. Once you are comfortable, you can attach Ellune to your waistband

using the clip on the reverse of the device.

5. Let Ellune do it’s work while you get on with the things you love. The

device will run until you press the power button or the battery

is exhausted.

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Taking Care of Your Ellune

Replacing the gel pads

For optimum effectiveness and hygiene, we recommend using one set of

gel pads per menstrual cycle.

At the start of your menstrual cycle, remove and dispose of the used gel

pads and replace with brand new pads.

Ensure your device is switched off when changing the gel pads.

Charging your Ellune

When Ellune’s battery is getting low, the

device will beep and the battery symbol on the

display will flash. This indicates that it is time to

recharge your device.

Take the charging cable supplied. Connect this into your Ellune device, and

connect the other end to a USB charger.

The battery symbol on the screen will show that the device is charging .

Once fully charged, the battery symbol will display 4 solid bars.

Ellune is compatible with fast-chargers. It takes approximately 1 hour to

fully charge the battery.

Cleaning and maintenance

Switch off Ellune before cleaning. Use a disinfectant or anti-

microbiological wipe.

Wipe all external surfaces of the device control unit and all cables.

Care should be taken not to clean the cable connectors.

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EN

Frequently Asked Questions

How long can I use Ellune for?

Ellune can be used as long as you are experiencing period pain.

The electrode pads should be removed and the site of application adjusted

at least every 10 hours. Regularly changing the site of application will

reduce the risk of skin irritation.

What is the right intensity level for me?

The right intensity level is one that feels comfortable for you and where it

begins to match the intensity of your pain.

How does Ellune work?

Ellune works by sending high-frequency electrical signals that are both

continuous and mild to block out the pain signals being delivered to the

brain. This is sometimes known as the “gate” control effect because it

reduces transmission of pain. When these pain signals are halted, pain

is not felt by the reactive area and the patient gets relief. Electrotherapy

also helps activate the natural pain control response, releasing beta

endorphins that ease the pain felt by the patient.

Can I use Ellune in combination with medication?

Yes, you can use Ellune in combination with medication you may be taking

Where can I obtain replacement parts and accessories?

Visit www.paingone.com or contact your local distributor

Can I place one pad on my abdomen and one on my back?

The maximum distance apart the electrode pads can be placed is 10cm.

To apply Ellune to the abdomen and the back at the same time requires 2x

Ellune devices.

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Issue Suspected cause Suggested action

No stimulation

from pads

Low battery or

connection error.

Fully charge Ellune's battery.

Check that the connection cable

is properly connected to the

electrode pads and to your Ellune

device, and that the cable is not

damaged.

No stimulation

from electrode

pads. Screen

displays

Connection error.

The electrode

pads may have

come loose from

the skin. Or the

connecting cable

may have detached

or be damaged.

Firmly press the electrode pads

against your skin. Check that

the connection cable is properly

connected to the pads and to your

Ellune device. Replace cable if

there are signs of damage.

Stimulation

feels weak

Poor connection or

worn gel pads

Firmly press the electrode pads

against your skin. If this does not

improve stimulation, apply brand

new gel pads to the

electrode pads.

Device beeps Low battery.

The beep sound

indicates that

battery is running

out

Fully charge Ellune's battery

Nothing displayed

on screen

Exhausted battery Fully charge Ellune's battery

Gel does not

adhere to the skin

Gel pads have

become overused

Replace the gel pads

Stimulation is felt

more strongly

through one

electrode pad

Poor positioning of

electrode pads

Ensure the electrode pads are

positioned on either side of your

pain and at the same height on

your body

Buttons are

not responsive

Lock function may

be active

Press the lock button once to

reactivate the other buttons

Troubleshooting

15

EN

Technical Details

Device specification

Model No: KTR-2302

Output: 0-45V

Intensity: 35 levels

Frequency: 100Hz

Pulse width: 120µ

Weight: 44g

Dimensions: 75×50×19.8mm

Power consumption: About 0.2W

Power source: 3.7V DC 500mAh

Power supply: Type-C USB 5V/9V DC

Input Power: 1.5W

Battery life cycles: Under normal use, the battery life is ≥500 recharge

cycles, about 2-3 years of use (30 minutes per day).

a. Environment for operation

Temperature: +5°C~+40°C

Humidity: 0%~80%

Barometric pressure: 86kpa~106kpa

a. Environment for storage:

Temperature: -25°C~+55°C;

Humidity: 0-93%RH

Barometric pressure: 50kpa~106kpa

a. Environment for transport

Temperature: -25°C~+55°C;

Humidity: 0-93%RH

Barometric pressure: 50kpa~106kpa

16

Glossary of Graphic Symbols

Symbol Explanation

Production Batch

Product catalogue reference code

Manufacturer (Directive 93/42/EEC amended by

Directive 2007/47/EC)

DATE OF MANUFACTURE. This symbol shall be

accompanied by a date to indicate the date of

manufacture

Caution

Applied part of type BF

European Authorized Representative

Do not dispose in household waste. Separate

collection for waste electric and electronic

equipment (WEEE) is required

CE marking with the Registration Number of the

Notified Body. This denotes compliance with European

Directive 93/42/EEC concerning medical devices.

Level of protection against the insertion of solid

bodies of size/diameter ≥ 12 mm and liquids in

the presence of dripping water when tilted at 15°

compared with products.

Refer to instruction manual/ booklet

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Safety and compliance standards

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: 2012+A1:2016 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

EMC & electrical standards/requirements

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.

This 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 a magnetic resonance imaging system,

in operating rooms near active AF surgical equipment, electrophysiology

laboratories, armored rooms or areas where short wave therapy

equipment is used.

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eDo not use the system around strong electric fields, electromagnetic

fields (e.g. MRI scan room) and mobile wireless communication

devices. Using the device in an improper environment may cause

malfunction or damage.

eThe compliance with EMC and EMI regulation cannot be guaranteed by

the use of modified cables or those which do not comply with the same

standards under which the equipment was validated.

eThe system must not be used adjacent to or supported by other

equipment.

eThe recommendations of this manual must be followed.

eDo 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.

ePortable 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.

eTo 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.

The following tables provide information on compliance of the equipment

according to the standard EN 60601-1- 2:2015.

19

EN

Electromagnetic emissions table

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 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.

Harmonic

emissions

IEC 61000-3-2

Class A

Voltage

fluctuations/

flicker emissions

IEC 61000-3-3

Complies

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Table 2 compliance standards

Phenomenon Basic

Standard of

Immunity Test Level of

Electrostatic

discharge

IEC 61000-4-2 ±8 KV contact

±2 KV, ±4 KV,

±8 KV,±15KV air§

±8 KV contact

± 2 K V, ± 4 K V,

± 8 KV, ±15KV air

Radiated RF EM

fields1

IEC 61000-4-3 3V/m

80 MHz-2.7 GHz

80% AM at 1 KHz

3V/m

80 MHz-2.7 GHz

80% AM at 1 KHz

Proximity

fields from

RF wireless

communication

equipment

IEC 61000-4-3 See table See table

Electrical Fast/

Transients

bursts

IEC 61000-4-4 ±1 KV

100 KHz

repetition

frequency

±1 KV

100 KHz

repetition

frequency

Conducted

disturbances

induced by RF

fields.

IEC 61000-4-6 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

Rated power

frequency

magnetic fields

IEC 61000-4-8 30 A/m

50 Hz or 60 Hz

30 A/m

50 Hz or 60 Hz

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