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TECHNICAL SPECIFICATIONS

Power supply

Ve: 90V~-240V~

   Vs: 5,0V. 1,2 A.

Frequency

50/60Hz.

Power

15VA

Light source

1 LED.

Active medium

Semiconductor Led (InGaN).

Wavelength

440nm - 460nm

Timer

90 seconds.

imer alarm

sound alarm with beep every 10
seconds and 4 beeps at the end
of the cycle.

Activation

Through the hand-piece button.

Light conductor

  Made out of special polymer, ro-

tational,  removable  and  reuse
sable.

Hand-piece body

ABS injected

Net weight

0.82 kg

Gross weight

  1.36 kg

Product classification:

In compliance with
NBR IEC 60601-1

Degree of protection
against electric shock:

B type

Electric shock protection
type:

Class two equipment.

Water leak protection

IPX 0

Application together with
anesthetic products that
could be inflammable in the
presence of air, oxygen or
nitrous oxide:

Not recommended

Warning:

  

The acrylic light conductor (pointer) is a material widely used in the dentist industry in partial and
complete prosthesis, orthodontic device, implants and many other applications that guarantees its
bio-compatibility with the mouth mucus.

Applied norms:

This product was tested and approved in compliance with the following standards:
EN 60601-1 (1990);
Amendment 1 EN 60601-1 (1992);
Amendment 2 EN 60601-1 (1995);
Amendment13 EN 60601-1 (1995);
EN 60601-1-2 (2001);

NBR IEC 601-1 (1994);
Emenda  1  NBR  IEC  601-1

(1994);

NBR IEC 601-1-2 (1997);
CISPR 11, edição 3.1 (1999);

IEC 61000-4-2 (1999);
IEC 61000-4-3 (1998);
IEC 61000-4-4 (1995);
IEC 61000-4-5 (1995);
IEC 61000-4-6 (1996);
IEC 61000-4-11 (1996);

This equipment was designed, manufactured and tested in compliance with the following standards:
NBR-IEC série 601-1 Equipamento Eletromédico - Parte 1: Prescrições gerais para segurança;
EN 980:2003 (Ed. 2)  - Graphical symbols for use in the labelling of medical devices;
ISO 14971 - Medical devices - application of risk management medical devices;
ISO 9687: 1993 -  Dental equipment - graphical symbols;
ISO 7494 - Norma dental units;
ISO 13485-2 - Quality systems - medical devices;
ISO 780 - Packaging - pictorial marking for handling goods;
ISO 11144 - Norma dental equipment - connections for suply and waste lines;

Summary of Contents for Optilight LD Max

Page 1: ......

Page 2: ...possible the multi functionality of this device Direct restoration procedures composite resins ionomers and adhesives Indirect restorations adhesive cementation of laminates inlays esthetic pins and metal free crowns Dental Bleaching activation of bleaching gel and polymerization of gingival barriers Compatible with 35 hydrogen peroxide based bleaching gels Attachment of braces and orthodontic acc...

Page 3: ...res Products manufactured in compliance with RDC 59 ANVISA Sanitary Surveillance NationalAgency which guarantees compliance with sanitary regulations concerning BPF Good Manufacturing Practices requested by Mercosul Sanitary authorities Note Use handpieces and accessories that comply with requirements of directive 93 42 EEC with CE mark IMPORTANT This equipment is exclusively for dental use It mus...

Page 4: ...ower Supply 02 Cable PP 2 20m 03 Optilight LD Max body 04 Pen 05 Ocular protector 06 Light conductor 07 Light conductor Whitening Tip 08 Display 09 On Off timer button 10 Time selection Whitening Tip 08 01 02 06 05 04 03 07 09 10 ...

Page 5: ...esis orthodontic device implants and many other applications that guarantees its bio compatibility with the mouth mucus Applied norms This product was tested and approved in compliance with the following standards EN 60601 1 1990 Amendment 1 EN 60601 1 1992 Amendment 2 EN 60601 1 1995 Amendment13 EN 60601 1 1995 EN 60601 1 2 2001 NBR IEC 601 1 1994 Emenda 1 NBR IEC 601 1 1994 NBR IEC 601 1 2 1997 ...

Page 6: ...peratures from 12ºC to 50ºC With maximum piling up of 13 units for storage Content of accessible and non accessible demarcations Special providence or particular conditions for installation Check the electric net it must be compatible with the specified one in the equipment Verify the general key of the equipment in the position 0 OBS These information also make part of the Manual of Installation ...

Page 7: ...or stored with care should not suffer drop and neither receive impact The packing must be stored and trans ported away from direct sun light exposure Temperature limit for the packing to be stored or transported Packing symbols TECHNICAL SPECIFICATIONS Product symbols Warning Consult the manual Landing in many parts of the equipment indicates the condition of being landed B type equipment Time sel...

Page 8: ...English 19 Dimensions mm TECHNICAL SPECIFICATIONS ...

Page 9: ...ght conductor tip 06 at least 2mm away from the restoration Keep the light conductor 06 always protected by an expendable PVC film which must be changed for every patient This procedure protects the light conductor from scratches and other residues Use the polymerization time recommended by the compound resin manufacturer and always perform restorations in incremental layers with a maximum thickne...

Page 10: ...LE AND OR REMOVABLE PARTS REPLACEMENT If stains fissures or scratchs where detected in the eyesight protection or in the light conductor replace damaged components Cleaning conductor The light conductor cleaning and the optical protector must be done using only neutral soap and cotton To the exterior of the pen use neutral soap or alcohol 70 vol Never use any other chemical based product than prev...

Page 11: ...pment Doubts and information GNATUS Call center 55 16 2102 5000 TROUBLESHOOTING FINAL CONSIDERATIONS ATTENTION Any other problem that could happen with its equipment should only be repaired by an authorized technician Gnatus The bad use negligence or maintenance not made by technician authorized by the maker will imply in the loss of the warranty Imprevisto Problem Probable Cause Solution Equipmen...

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