mectron Silverlight Manual Of Use And Maintenance Download Page 16

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silverlight - manual of use and maintenance  

 DANGER: Do not short-circuit the electric contacts of the handpiece with metal objects or 

liquids.

 DANGER: The handpiece should not be sterilized.

Proceed as follows after each treatment:

Remove the fiber optic and optical protection from the handpiece.

Clean and disinfect the surface of the handpiece using a cloth moistened with a solution of mild 
detergent/disinfectant having a neutral pH (pH = 7). Follow carefully the instructions provided by the 
manufacturer of the disinfectant solution. 

 

Allow the disinfectant solution to air dry on the handpice before placing  it back in the recharging unit. 

 

Above all, make sure that the electric contacts are completely dry.

NOTE:

 Water-based disinfectants with a neutral pH are strongly recommended. Some alcohol-based 

disinfectant solutions may be harmful and cause damage to plastic materials.

07.3  Sterilization procedure

 

WARNING: Carry out sterilization only in a steam autoclave.

Do not use any other sterilization 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 avoid infection caused by bacteria or viruses, always clean the following components after each 
treatment:
1.  Fiber optic;
2.  Optical protection.
Sterilization of the above components have been validated by independent laboratory, using a 

 

pre-vacuum steam autoclaving.
Recommend  minimum sterilization parameters that provide a 10

-6

 Sterility Assurance Level (SAL):

Three times pre-vacuum cycle 

Minimum sterilization temperature: 132°C (interval 0 °C; + 3 °C)

Sterilization  time: 4 minute

Drying Time: 10 min

Do not exceed 135°C

07.4  Cleaning, disinfection and sterilization of the optical fiber

 

WARNING: Do not use sharp-edged objects to clean the fiber optic.

Carry out the following operations:
1.  Eliminate any residues of polymerized composites from the surface of the fiber optic with alcohol.
2.  Disinfect the surface using a cloth moistened with a solution of mild detergent/disinfectant having a 

neutral pH (pH = 7).

3.  Dry.

4.  Seal the fiber optic in a disposable bag on its own.
5.  Autoclave sterilize the fiber optic.

Summary of Contents for Silverlight

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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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