E-Swin E-Eye User Manual Download Page 24

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Immunity test

IEC60601 Test Level

Compliance Level

Electromagnetic Environment - Guidance

Electrostatic Discharge 

(ESD)

IEC 61000-4-2

± 8 kV contact

± 15 kV air

± 8KV contact

± 15kV air

Floors should be wood, concrete or ceramic tile. If floors 

are covered with synthetic material, the relative humidity 

should be at least 30%.

Electrical fast transient 

/ burst

IEC 61000-4-4

± 2 kV 100 kHz

± 2 kV 100 kHz

Mains power quality should be that of a typical public low 

voltage power supply network.

Surge

IEC 61000-4-5

± 1 kV differential mode

± 2 kV common mode

± 1 kV differential mode

± 2 kV common mode

Mains power quality should be that of a typical public low 

voltage power supply network.

Voltage dips, short 

interruptions and voltage 

variations on power 

supply input lines

IEC 61000-4-11

0 % UT for 0.5 cycle at 

45,90,135,180,225,270,315°

0% Ut for 1 cycle at 0°

70% for 25/30 cycle at 0°

0% for 250/300 cycle, any 

angle

0 % UT for 0.5 cycle at 

0,45,90,135,180,225,270,315°

0% Ut for 1 cycle at 0°

70% for 25/30 cycle at 0°

0% for 250/300 cycle, any 

angle

Mains power quality should be that of a typical public 

low  voltage  power  supply  network.  If  the  user  of  the 

device requires continued operation during power mains 

interruption, it is recommended that device be powered 

from an uninterruptible power supply or a battery.

Power frequency 

(50/60Hz) magnetic field

IEC 61000-4-8

30 A/m

30 A/m

Power  frequency  magnetic  fields  should  be  at  levels 

characteristics of a typical location of a typical location 

connected to public low voltage power supply network.

Conducted RF

IEC 61000-4-6

Radiated RF

IEC 61000-4-3

3Vrms

150 kHz to 80MHz

6 V for ISM band

3V/m

80 MHz to 2.7 GHz

3Vrms

150 kHz to 80MHz

6 V in ISM bands between 150 

kHz to 80MHz

3V/m

80 MHz to 2.7 GHz

NOTE 1:

 UT is the ac mains voltage prior to application of the test level.

NOTE 2:

 At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 3:

  These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption an reflection from structures, objects 

and peoples.

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 exceed 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 reorienting or relocating the device.
Over the frequency range 150 kHz to 80 MHz, field strength should be less than 3 V/m.

TECHNICAL        CHARACTERISTICS

 GUIDANCE AND MANUFACTURER’S DECLARATION 

RADIO FREQUENCY EMISSIONS

The 

 is equipped with a radio-frency transmitter at 13.56 MHz in an ASK modulation, and at a power lower than 42 dB(µA/m)à 10m. 

ELECTROMAGNETIC EMISSIONS 

The device is intended for use in the electromagnetic environment specified below. The user should assure that it is used in such an envi

-

ronment.used in such an environment.

Emissions Test

Compliance

Electromagnetic Environment - Guidance

RF emissions

CISPR 11

Group 1

The device uses RF energy only for its internal function. Therefore, its radiated emissions are 

very low and are not likely to cause interference in nearby electronic equipment.

RF emissions - 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 uses for domestic purpose.

Harmonic emissions - IEC 61000-3-2

Class A

Voltage fluctuations / Flicker emissions - 

IEC 61000-3-3

Passed

ELECTROMAGNETIC IMMUNITY 

The device is intended for use in the electromagnetic environment specified below. The user of the device should assure that it is used in 

such an environment.

a

b

TO AVOID ELECTROMAGNETIC SUSCEPTIBILITY ISSUES ON 

 

AND ITS SURROUNDED DEVICES, USER 

SHALL FOLLOW THE FOLLOWING RULES FOR INSTALLATION

WARNING:

 Use of this equipment ad-

jacent to or stacked with other equip

-

ment should be avoided because it 

could result in improper operation. If 

such use is necessary, this equipment 

and the other equipment should be 

observed to verify that they are ope-

rating normally.

WARNING:

 Use of accessories, trans-

ducers and cables other than those 

specified or provided by the manufac

-

turer of this equipment could result in 

increased electromagnetic emissions 

or decreased electromagnetic immu-

nity of this equipment and result in 

improper operation.

WARNING:

 Portable RF communi-

cations equipment (including peri-

pherals such as antenna cables and 

external antennas) should be used no 

closer than 30 cm (12 inches) to any 

part of 

, including cables spe-

cified by the manufacturer. Otherwise, 

degradation of the performance of 

this equipment could result.

Summary of Contents for E-Eye

Page 1: ...User Manual...

Page 2: ...nging and is a practical example of this fact Your patients can now enjoy the benefits of a new treatment for meibomian blepharitis dry eye syn drome using state of the art pulsed light technology wit...

Page 3: ...ETC The manufacturer s guarantee for parts and labour will only be valid if your device is returned in its complete original packaging All items of original packaging in which your was delivered shou...

Page 4: ......

Page 5: ...onal user of must ensure that only persons who fulfil the criteria for use described in the present manual will receive treatment using Before using your the following information should be read caref...

Page 6: ...lement for less than two months On an injured burned or infected skin On skin lesions of unusual appearance which will require investigation On high risk areas blemishes birthmarks warts unhealed woun...

Page 7: ...nection Activation card slot Applicator holding Ventilation grid Visor to protect touchscreen Mobile head Release clips for the mobile head Mobile head Applicator zone Applicator zone Air vents Trigge...

Page 8: ...use of the device 13 Pause icon for the flash treatment session pressing this icon will place in pause mode In this mode no flash can be emitted from the applicator To exit this mode press the same i...

Page 9: ......

Page 10: ...plicator photo 3 Push the extractor into the mobile head to its full length photo 4 Apply pressure simultaneously to the 2 retaining lugs of the mobile head and remove the mobile head photo 5 Remove t...

Page 11: ...nce entered these codes will not be requested a second time Connect using the mains lead The internal test procedure of will commence and will last for a few seconds Upon the completion of this phase...

Page 12: ...n a generous layer minimum 1cm thick on the cheekbone and the tempo ral areas making sure that the gel does not get under the eye mask Locate your mask goggles and put them on If there are other perso...

Page 13: ......

Page 14: ...tivation card and its optic cartridge must be replaced when the number of flashes reaches zero STAGE 2 COOLING OF OPTICAL PARTS During the procedure for the replacement of the optic cartridge before s...

Page 15: ...tridges are not symmetrical so they must be inserted in the right sense and certainly not in the other Check that the cartridge is correctly engaged PRECAUTIONS throughout the procedure for the replac...

Page 16: ...the old activation card and insert the new card supplied with the optic cartridge in the slot provided for this purpose photo I Each activation card carries the same serial number as the optic cartrid...

Page 17: ...on icon 7 The C key can be used to correct the figure in each box SELECT LANGUAGE screen L Click on the flag which corresponds to the required language The Language change confirmed message will be d...

Page 18: ......

Page 19: ...o danger or entail the risk of irreparable damage to your device Once o p t i c cartridge is removed it should be handled by the plastic parts only above all the electrodes the tube or the reflector s...

Page 20: ...sothiazolinone 0 05 0 15 Deionized water Q S 100 For external use only Not to be used on broken burned or infected skin Keep out of reach of children The tool extractor is used for the separation of t...

Page 21: ...of your device Never apply the clean spray directly to the internal components of the applicator APPLICATOR BODY All plastic components of the applicator must be cleaned using a clean cloth which has...

Page 22: ...ols of the optical parts of the applicator to end SECU 03 SECU 04 SECU 05 SECU 07 SECU 09 Your device is blocked Contact our technical department by filling out the contact form on www esw vision com...

Page 23: ...pheric pressure 70 106 kPa MARQUAGE Reference to the treatment of meibomian blepharitis dry eye syndrome using device Unique serial number of your E SWIN Rue des C tes d Orval ZA de la Pr v t 78550 Ho...

Page 24: ...considered If the measured field strength in the location in which the device is used exceed the applicable RF compliance level above the device should be observed to verify normal operation If abnor...

Page 25: ...or the applicator as you may risk exposure to high voltages Never use cartridges and acces sories other than those designated and sold by E Swin SAS for use with ENVIRONMENTAL PROTECTION You must abi...

Page 26: ...ns described in this manual will invalidate the guarantee The company E Swin SAS will not accept liability for any accident arising from failure to observe the instructions contained in this manual or...

Page 27: ...0197 ZA de la Pr v t Rue des C tes d Orval 78550 Houdan FRANCE 01 30 46 37 61 www esw vision com M029GB000F08A rev F 2021 06 11...

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