Gnatus Persus L User manual

2

PRESENTATION OF MANUAL

OWNER’S MANUAL INSTRUCTIONS FOR USE

Technical Name: Dental Light
Trade Name: Persus L Dental Light
Brand: GNATUS

Manufacturer/ Distribuitor:

GNATUS - EQUIPAMENTOS MÉDICO-ODONTOLÓGICOS LTDA.
Rod. Abrão Assed , Km 53+450m - Cx. Postal 782 CEP 14097-500
Ribeirão Preto - S.P. - Brasil
Fone [phone] - Fax [phone]
C.N.P.J. 48.015.119/0001-64 - Insc. Est. 582.329.957.115
www.gnatus.com.br - [e-mail]
Technical Duties: Gilberto Henrique Canesin Nomelini
CREA-SP: 0600891412

Registration ANVISA nº: 10229030063

ATTENTION

For greater safety:

Read and understand all the instructions contained in these

instructions for use before installing or operating this equipment.

Note: These instructions for use must be read by all the operators

of this equipment.

3

INDEX

PRESENTATION OF MANUAL ........................................................................02

IDENTIFICATION OF EQUIPMENT .................................................................04

- Indication of Equipment ................................................................................04

- Equipment Description ...................................................................................04

MODULES, ACCESSORIES, OPTIONS AND MATERIALS OF CONSUMPTION .....05

TECHNICAL SPECIFICATIONS .......................................................................07

- General ........................................................................................................07

- Standards applied .........................................................................................07

- Dimensions ..................................................................................................08

- Packing symbols ...........................................................................................12

- Product symbols ...........................................................................................12

- Content of accessible and non-accessible demarcations .....................................12

- Electromagnetic emissions ..............................................................................13

INSTALLATION OF EQUIPMENT ....................................................................16

OPERATION OF EQUIPMENT .........................................................................16

PRECAUTIONS, RESTRICTIONS AND WARNINGS ..........................................18

- Transportation, storage and operation ..............................................................18

- Sensitiveness to environmental conditions foreseeable in normal situations of use .18

- Precautions and warnings “during the installation” of equipment ..........................18

- Recommendations for preserving the equipment. ...............................................18

- Precautions and warnings “during the use” of equipment ....................................19

- Precautions and warnings “after” the use of equipment ......................................19

- Precautions and warnings during the “cleaning and disinfection” of equipment .......19

- Precautions in case of alteration in the functioning of equipment ..........................19

- Precautions to be adopted against foreseeable or uncommon risks,

related to the deactivation and abandoning of equipment ......................................20

CORRECTIVE AND PREVENTIVE MAINTENANCE AND PRESERVATION............20

- Additional procedures for reuse .......................................................................20

- Cleaning ......................................................................................................20

- Disinfection ..................................................................................................21

- Replacing the Reector’s lamp .........................................................................21

- Replacing the fuses .......................................................................................22

- Preventive Maintenance .................................................................................22

- Corrective Maintenance ..................................................................................22

UNFORESEEN EVENTS – SOLUTION OF PROBLEMS ........................................23

WARRANTY OF EQUIPMENT ..........................................................................23

FINAL CONSIDERATIONS ..............................................................................23

4

IDENTIFICATION OF EQUIPMENT

Dear Customer

Congratulations. You have made a good choice when you decided to buy a GNATUS
QUALITY product comparable to the best products available in the World. This manual is a
general presentation of your product and it will give you important details to help you to
solve possible problems.

Please, read it and keep this with you.

Indication of Equipment

This equipment is for dental use use only. It must be operated and utilized by specialized

professional (certied professional, according to the legislation of the country) and following

the instructions of the manual.

The operation of the equipment required, for the professional, the utilization of correct
instruments and it should to be in perfect conditions of the use, and to protect the professional,
the patients and others, in the eventual danger situation.

Equipment Description

Focal dental reector with multi intensity light ranging from 8.000 to 25.000 Lux.

Hinged arm with horizontal and vertical movements with a stroke limit jamb, sustained
by a set of springs that allow a smoother and accurate movement.

Handle-shaped bilateral knobs, embedded to the head. With an appropriate design for
placing sterilized protectors avoiding the risk of cross contamination.

Multi-sided glass mirror with multi-coating treatment generates several white and cold

light sources. Do not provoke shadows caused by the surgeon dentist’s hands or head

interposition.

Sturdy and easy to remove hollow optical mirror protector, making the lamp replacement
easier.

Trigging through the chair’s control paddle*, optimizing biosafety or through a switch
shaft* embedded to the reector’s head (depending on the coupling).

Flat high gloss epoxy painting polymerized in an oven at 250°C; with corrosion and
cleaning material resistant phosphate treatment. Ice colored as standard, compatible with
every environment.

In order to ensure a safety working of you unit, only use the assembly setup (Chair,

Equipment, water unit and reector) supplied by Gnatus Authorized Resale / Technical

Assistance.

ISO 9001 and ISO 13485 quality systems, assuring that the products are produced
within standard procedures.

Products manufactured in compliance with the resolution RDC 16/13 – Brazil Health
Surveillance Agency - ANVISA.

* Optional item

5

MODULES, ACCESSORIES, OPTIONS AND MATERIALS OF
CONSUMPTION

07

02

05

The content on this page is informative; the equipment can be different from
those illustrated. Therefore, when purchasing the product check the technical
compatibility between equipment, coupling and accessories.

* Optional item

04

09

01 06

01 - Switch Shaft On/Off

*

02 - Multi-sided glass mirror
03 - Protective cover
04 - Handles
05 - Bulb protector
06 - Bulb
07 - Hinged arm

03

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MODULES, ACCESSORIES, OPTIONS AND MATERIALS OF
CONSUMPTION

01

*Supports for coupling

to the chair

(Allows the installation of the

hinged arm)

04

02

*Support for coupling

oor/ceiling

(Allows the installation of the

hinged arm)

03

*Hinged arm

05

*Double stand hinged arm

The use of the options must be checked at the time of buying.
Therefore, when buying the product, check the technical
compatibility between the equipment, coupling and
accessories.

The use of any part, accessory or material non-specied
or provided Within these use instructions is of the user’s

entire responsibility.

The coupling supports may vary according the purchased
model of chair.

*Orbital movement (Allows many angles within the
operatory eld illumination).

* Optional item

*Simple stand

hinged arm

06

*Bush Kit

(Allows the xation of the reector

in the ofce with 38mm columns)

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TECHNICAL SPECIFICATIONS

General

Classification of Equipment as per ANVISA:

Class I
Classification of Equipment as per standard IEC 60601-1:
Protection against Electric Shock - Type B and Class I Equipment (IEC 60601-1)

Protection against harmful water penetration:

IPX 0

Mode of Operation:

Continuous operation

Installation options:

Chair, stand, oor and ceiling

Tension / frequency:

12V~: Reector coupled to the dental chair
127/220V~ 50/60Hz: Reector coupled to the oor, stand and ceiling

Power consumption:

55VA

Luminosity:

8.000 a 25.000 LUX ±20%

Lamp:

H3 12V 55W

Fuses:

5A

Distance between the headstock and the operative field:

70cm

Net weight / Gross:

headstock: 1,0kg / 1,5Kg

Packing dimensions:
23 x 32 x 45 cm

Standards applied:

NBR 60601-1:1997 - Equipamento Eletromédico- Parte 1: Prescrições gerais para segurança;
NBR ISO 14971:2004- Medical devices - application of risk management medical devices;
NBR ISO 9687: 2005 - Dental equipment - graphical symbols;
EN ISO 13485-2003 - Quality systems - medical devices;
IEC 60601-1-2:2007 - Compatibilidade Eletromagnética;
NBR ISO 9680:2001 - Aparelho de iluminação bucal

8

TECHNICAL SPECIFICATIONS

Dimensions (mm)

(Standard arm)