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3 

1   INTRODUCTION 

4

 

1.1

 

R

ELEVANCE OF THIS 

M

ANUAL

 

4

 

1.2

 

M

ANUAL CONSERVATION

 

4

 

1.3

 

W

ARNINGS

 

4

 

2

 

SYMBOLS 

6

 

3

 

GENERAL INFORMATION 

7

 

3.1

 

I

NDICATION OF USE

 

7

 

3.2

 

A

CTION MECHANISM

 

7

 

3.3

 

E

XPECTED PERFORMANCES

 

7

 

4

 

PRODUCT DESCRIPTION 

8

 

4.1

 

D

ESCRIPTION OF THE 

D

EVICE AND ACCESSORIES

 

8

 

4.2

 

G

ENERAL

 

8

 

4.3

 

O

PERATING INSTRUCTIONS

 

9

 

5

 

DEVICE USE 

11

 

5.1

 

D

EVICE REGISTRATION AND DAY AND TIME SETTING

 

11

 

5.2

 

S

ERVICE 

A

REA

 

11

 

5.2.1

 

T

REATMENTS RECHARGE

 

12

 

5.2.2

 

C

OUNTERS

 

12

 

5.3

 

T

HERAPEUTIC USE OF THE 

D

EVICE

 

12

 

5.4

 

D

ISTANCE 

S

ENSOR

 

14

 

5.5

 

O

PERATIONS TO BE ACCOMPLISHED AFTER 

D

EVICE

’

S USE

 

14

 

6

 

LABELS 

15

 

7

 

WARNINGS/ERROR MESSAGES/MALFUNCTIONS 

16

 

8

 

DEVICE MANAGEMENT 

17

 

7.1

   

C

ORRECT USE

 

17

 

7.2

   

D

EVICE CONSERVATION

 

17

 

7.3

   

P

ACKAGING AND SHIPPING

 

17

 

7.4

   

D

ISPOSAL

 

17

 

9

 

TECHNICAL DATASHEET 

18

 

10

 

ELECTROMAGNETIC COMPATIBILITY 

19

 

11

 

GLOSSARY 

23

 

12

 

GUARANTEE 

24

 

MANUFACTURER COMMUNICATION FORM 

25

 

 
 
 
 
 
 

Содержание Emoled

Страница 1: ...uded in this Manual before using Read carefully the instructions included in this Manual before using Read carefully the instructions included in this Manual before using Read carefully the instructio...

Страница 2: ...2 Document 8300010001_UM_rev 3 31 01 19 Emoled srl Registered office Via della Cernaia 5 50129 Firenze Headquarters Via di Rimaggio 141 int 25 500019 Sesto Fiorentino www emoled com...

Страница 3: ...5 1 DEVICE REGISTRATION AND DAY AND TIME SETTING 11 5 2 SERVICE AREA 11 5 2 1 TREATMENTS RECHARGE 12 5 2 2 COUNTERS 12 5 3 THERAPEUTIC USE OF THE DEVICE 12 5 4 DISTANCE SENSOR 14 5 5 OPERATIONS TO BE...

Страница 4: ...al in an environment protected from humidity and heat This document is exclusive property of EMOLED Srl It is forbidden any copy or reproduction even partial of its contents 1 3 Warnings ATTENTION THE...

Страница 5: ...lace device in its case if possible and contact assistance www myemoled com contacts IN CASE OF TOUCH SCREEN DAMAGE OR NOT WORKING Do not use the Device Proceed with a maintenance intervention request...

Страница 6: ...umeric code identifies the Device Serial Number ISO 7000 2497 symbol shows the date of manufacturing of the Device ISO 7000 3082 symbol identify the manufacturer of the Device according to EU directiv...

Страница 7: ...necessary during the wound s healing process Through the activation of the Flavins the Blue Light stimulates the production of ROS reactive oxygen species signal transducers that induce activities to...

Страница 8: ...B port Supplied Accessories are the charger shown in Fig 20 the screen for visual comfort to be placed on the Optical Head before starting application see Fig 6 UV filtering glasses 4 2 General The De...

Страница 9: ...l comfort 2 Clean the Device with sterile gauze soaked in ethylic alcohol at 50 3 Place the accessory screen on the Optical Head near to the front frame as shown in Fig 6 4 Set the Optical Head in the...

Страница 10: ...e sanitary personnel if not described in the present manual are to be considered as use errors or improper use 3 4 Functions of the ON OFF Button The ON FF button see Fig 2 has different functions swi...

Страница 11: ...creen appears the Device s preset identifying serial number that is also visible on the label placed at the bottom of the body see section 5 Go on pressing OK 4 Disclaimer automatically on the desplay...

Страница 12: ...y in combination with the devices they have been create for 5 2 2 Counters Once got to the service area and pressed the counters button appear a series of data that are useful in case of remote assist...

Страница 13: ...leted message 5 At the end of the treatment the Device goes back to Home screen Here below are represented in detail the indicators and the information present on display in the Assistant to applicati...

Страница 14: ...d even if the applications aren t ended and on the display appears the Home screen 5 5 Operations to be accomplished after Device s use After use it is necessary to perform the following operations fo...

Страница 15: ...f device and accessories labelling FIGURE 20 Labels on the Device FIGURE 21 Labels on accessories RISK GROUP 3 CEI EN 62471 2010 WARNING UV emission Do not stare into beam Electrical parameters Charge...

Страница 16: ...es not turn on None Check the battery charge Connect the Device to the main power and check the charge level If the problem remains contact the assistance The Device does not recharge None Check the c...

Страница 17: ...cal Head do not put the Device or part of it in fluids or liquids do not point the light in the eyes 7 2 Device conservation For a correct conservation of the Device and the preservation of its charac...

Страница 18: ...NDWIDTH 400 430 nm POWER DENSITY IRRADIANCE 120 mW cm2 IRRADIATED AREA 20 cm2 ENERGY DENSITY FLUENCE 7 2 j cm2 TREATMENT DISTANCE 3 5 cm distance sensor inside POWER OUTPUT 2 3 W max emission variatio...

Страница 19: ...pose means of protection like reorient the device or to shield the environment Harmonic emissions IEC 61000 3 2 Class A Voltage fluctuations flicker emissions IEC 61000 3 3 Conforms Table 2 Guidance a...

Страница 20: ...or 5 cycles 70 UT 30 dip in UT For 25 cycles 5 UT 25 dip in UT For 5 s The amount of the network tens should be that of a typical commercial or hospital environment If the user of the EmoLED device re...

Страница 21: ...ce calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 2 sqrt P d 0 35 sqrt P 80 MHz to 800 MHz d 0 70 sqrt P 800 MHz to 2 5 GHz Where P is...

Страница 22: ...transmitter m Rated maximum output power of transmitter W 150 KHz to 80 MHz d 1 2 sqrt P 80 MHz to 800 MHz d 1 2 sqrt P 800 MHz to 2 5 GHz d 2 3 sqrt P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2...

Страница 23: ...tions needed for the cell to survive Photoacceptor a particular category of sensitive and light reactive proteins located in different cell types The effect of stimulation with light of these proteins...

Страница 24: ...s and safety controls executed by technician different from expert personnel qualified trained and authorized by the Manufacturer Direct or indirect damages or accidents to people animals or objects d...

Страница 25: ...________________________________ _______________________________________________________________________________________ _______________________________________________________________________________...

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