mectron Silverlight Скачать руководство пользователя страница 21

21

silverlight - manual of use and maintenance  

Guidance and manufacturer’s declaration - Electromagnetic immunity

The Silverlight is intended for use in the electromagnetic environment specified below.

 

The customer or the user of the Silverlight should assure that it is used in such an environment.

Immunity test

IEC 60601

test level

Compliance level

Electromagnetic envi-

ronment - 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
floors 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

±2 kV for power supply 
lines

±1 kV for input/output 
lines

Mains power qual

-

ity should be that of a 
typical
commercial or hospital 
environment.

Surge

IEC 61000-4-5

±1 kV differential mode
±2 kV common mode

±1 kV differential mode
±2 kV common mode

Mains power qual

-

ity should be that of a 
typical
commercial or hospital 
environment.

Voltage dips, short in

-

terruptions and voltage 
variations on power 
supply input lines

IEC 61000-4-11

<5 % U

T

 (>95 % dip in 

U

T

) for 0,5 cycle

40 % U

T

 (60 % dip in 

U

T

) for 5 cycle

70 % U

T

 (30 % dip in 

U

T

) for 25 cycle

<5 % U

T

 (>95 % dip in 

U

T

) for 5 s

<5 % U

T

 (>95 % dip in 

U

T

) for 0,5 cycle

40 % U

T

 (60 % dip in 

U

T

) for 5 cycle

70 % U

T

 (30 % dip in 

U

T

) for 25 cycle

<5 % U

T

 (>95 % dip in 

U

T

) for 5 s

Mains power qual

-

ity should be that of a 
typical commercial or 
hospital environment.

Power frequency 

(50/60 Hz) magnetic 
field

IEC 61000-4-8

3 A/m

3 A/m

Power frequency 

magnetic fields should 
be at levels character

-

istic of a typical location 

in a  

typical commercial or 
hospital environment.

NOTE: U

T

 is the a.c. mains voltage prior to application of the test level.

Содержание Silverlight

Страница 1: ...Manual of use and maintenance...

Страница 2: ...l 10 05 4 Battery failed signal 10 05 5 Battery problems 10 05 6 Safety requirements relating to the battery 10 06 0 Use 11 06 1 Connecting the accessories 11 06 2 Safety requirements during use 12 06...

Страница 3: ...dated to the date of publication indicated on the last page The manufacturer Mectron S p A is committed to continuous updating of products which may entail changes to components of the equipment If th...

Страница 4: ...Do not use this equipment on patients fitted with pace makers or any other implantable electronic devices This requirement applies equally to the operator DANGER Point the beam of light directly at t...

Страница 5: ...R Do not install the equipment anywhere there is a risk of explosions The equipment cannot function in places where there is an inflammable atmosphere anesthetic mixtures oxygen etc DANGER Do not use...

Страница 6: ...re ensures proper functioning and reliability of all components 03 0 Delivery 03 1 Delivery of the device The equipment contains electronic components that may be damaged by impacts even inside the pa...

Страница 7: ...verlight recharging unit Fig 3 Ref A B Silverlight handpiece with rechargeable lithium ion battery Fig 3 Ref B C Fiber optic Fig 3 Ref C D Optical protection Fig 3 Ref D E Power supply cable for the r...

Страница 8: ...GER Do not short circuit the electric contacts of the recharging unit with metal objects Fig 5 Ref B and do not touch them with your hands while the apparatus is switched on WARNING The apparatus is t...

Страница 9: ...aced on the recharging unit the green battery LED does not switch on This is normal Description of the acoustic signals of the handpiece Table 2 Function Push button control Acoustic signal FAST polym...

Страница 10: ...eck the battery continuously and maintain the optimum battery charging parameters The handpiece may therefore be placed back into the recharging unit at the end of each treatment and left there regard...

Страница 11: ...wer LED will light up 05 5 Battery problems To replace a failed battery contact GC America Inc Customer Service Do not attempt to open remove change replace or in any other way adjust the battery Thes...

Страница 12: ...circuit the battery terminals This could cause burns and fire 06 0 Use 06 1 Connecting the accessories DANGER Check the condition of the device before the treatment Before each treatment always make s...

Страница 13: ...t efficient this will reduce the intensity of the light being emitted considerably In such cases it should therefore be replaced 06 3 Instructions for use The silverlight can be used in two different...

Страница 14: ...the working luminous flux measured Green luminous flux suitable for effective treatment Red luminous flux insufficient WARNING If the working luminous flux is not sufficient do not proceed with the t...

Страница 15: ...fection disconnect the recharging unit from the main power supply DANGER The casing of the recharging unit is not protected against the entry of liquids DANGER Do not spray liquids directly onto its s...

Страница 16: ...ilization procedures dry heat radiation ethylene oxide gas low temperature plasma etc DANGER The handpiece and recharging unit must not be sterilized DANGER Infection control Sterilizable parts To avo...

Страница 17: ...he battery must be disposed of and treated as waste requiring separate collection This equipment must be disposed of and treated as waste requiring separate collection Dispose of unserviceable batteri...

Страница 18: ...is ON Battery failed Contact GC America Inc Customer Service See point 05 4 and 05 5 There is no beam of light when the push button of the Silverlight is pressed and an acoustic signal is heard two be...

Страница 19: ...ed in transparent quartz Sterilizable by steam autoclave Minimum sterilization parameters Three times pre vacuum cycle at 132 C for 4 minutes Drying time 10 minutes max temp 135 C max 500 cycles Expos...

Страница 20: ...environment Guidance RF emissions CISPR 11 Group 1 The Silverlight uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference i...

Страница 21: ...ins power qual ity should be that of a typical commercial or hospital environment Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power qual i...

Страница 22: ...gths from fixed RF transmit ters as determined by an electromagnetic site survey a should be less than the com pliance level in each frequency rangeb Interference may occur in the vicinity of equipmen...

Страница 23: ...er of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 5 GHz d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1...

Страница 24: ...her than GC America Inc authorized personnel The warranty is valid only if GC America Inc is notified within thirty 30 days following discovery of a defect For returning procedure make reference to th...

Страница 25: ...the equipment in its original packaging to ensure it is not damaged during shipment DANGER All the products must be cleaned and sterilized before returning GC America Inc will not accept and process p...

Страница 26: ...063 Fax 800 GCFAXME Caution US Federal Law restricts this device to sale by or on the order of a dentist silverlight V USA Rev 01del 02 18 2010 manufacturer Mectron S p A Via Loreto 15 A 16042 Carasco...

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