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9. RULES AND REGULATIONS

This equipment has been designed and manufactured to meet the following standards:

ABNT NBR IEC 60601-1:2010

Amendment 1:2016

Medical Electrical Equipment - Part 1: General requirements

for basic safety and essential performance.

ABNT NBR IEC 60601-1-2:2017

Medical Electrical Equipment, Part 1-2: General requirements

for basic safety and essential performance - Collateral

standard: Electromagnetic interference - Requirements

and tests.

ABNT NBR IEC 80601-1-60:2015

General requirements for basic safety and essential

performance of dental equipment

ABNT NBR 60601-1-6:2011

Electro-medical equipment - Part 1-6: General requirements

for basic safety and essential performance - Collateral

standard: Usability;

ABNT NBR IEC 62366:2016

Healthcare products - Application of usability engineering

to healthcare products;

IEC 60601-1-9:2014

Medical electrical equipment - Part 1-9: General

requirements for basic safety and essential performance

- Collateral standard: Requirements for environmentally

conscious design

IEC 62304:2006

Medical device software - Software lifecycle processes.

ISO 9680:2014

Operating lights

ISO 7494-1:2018

Dentistry – Dental units – Part 1: General requirements

and test methods

ISO 7494-2:2015

Dental units – Part 2: Air, water, suction and wastewater

Systems

ABNT NBR ISO 6875:2014

Dental patient chair

ISO 9687:2015

Graphical symbols for dental equipment

ISO 15223-1:2016

Graphic symbols for electrical equipment in medical

practice

EN 1041:2008+A1 2013

Information provided by the medical device manufacturer.

ABNT NBR ISO 10993-1:2013

Biological assessment of medical devices - Part 1:

Assessment and testing.

ABNT NBR ISO 14971:2009

Medical devices - Application of risk management to

medical devices.

ABNT NBR ISO 13485:2016

Quality management systems - Requirements for

regulatory purposes

Содержание Dental Light

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Страница 3: ...A SP 5062199650 ANVISA Registration No 10069210069 Document originally written in Portuguese Alliage S A Industrias Médico Odontológico Rodovia Abrão Assed Km 53 Zip Code 14097 500 Ribeirão Preto SP Brazil Phone 55 16 3512 1212 CINTERQUAL Soluções de Comércio Internacional Lda Rua Fran Pacheco No 220 2nd floor 2900 374 Setúbal Portugal 77000000693 Rev 03 November 20 ...

Страница 4: ...registered trademarks or service marks of their respective owners Alliage S A makes no claims regarding these trademarks The use of a term in this manual should not be considered to influence the validity of any registered mark registered trademark or service mark Copyright 2019 Alliage S A All rights reserved The performance characteristics provided in this manual are for reference only and shoul...

Страница 5: ... 6 SYSTEM REQUIREMENTS 20 3 6 1 Place of Installation 20 4 OPERATION 22 4 1 INITIAL PREPARATION 22 4 2 ACTIVATING THE LIGHT 22 4 3 MOVEMENT OF THE HEADSTOCK 24 5 CLEANING AND DISINFECTION 26 6 PROBLEMS DIAGNOSTIC 28 6 1 PROBLEMS SOLUTION 28 7 INSPECTION AND MAINTENANCE 30 7 1 PERIODIC INSPECTION 30 7 2 PREVENTIVE MAINTENANCE 30 7 3 CORRECTIVE MAINTENANCE 31 7 4 ALLIAGE AUTHORIZED SERVICE NETWORK 3...

Страница 6: ...6 11 ELECTROMAGNETIC COMPATIBILITY 45 11 1 GUIDANCE AND DECLARATION FOR ELECTROMAGNETIC EMISSIONS 45 11 2 GUIDELINES AND DECLARATION FOR ELECTROMAGNETIC IMMUNITY 46 ...

Страница 7: ...7 1 GERENAL INFORMATION Alliage S A Industrias Médico Odontológico Telephone 55 16 3512 1212 Rodovia Abrão Assed Km 53 Zip Code 14097 500 Ribeirão Preto SP Brazil ...

Страница 8: ...1 2 INDICATONS FOR USE The Dental Light is intended to assist in the treatment of the patient and in the performance of dental practices and is for dental use only 1 3 CONTRAINDICATION There are no known contraindications for this equipment 1 4 SYMBOLOGY The following symbols are used both throughout this manual and on the product Make sure you fully understand each symbol and follow the instructi...

Страница 9: ...rall warning Authorized representative in European Union Indicates that the equipment complies with Directives 2011 65 EU and 2015 863 EU on the Restriction on the use of certain hazardous substances in electrical and electronic equipment Model Catalog number Model number Serial number Manufacturer Manufacturing date ...

Страница 10: ...10 2 WARNINGS PRECAUTIONS AND RECOMMENDATIONS Alliage S A Industrias Médico Odontológico Telephone 55 16 3512 1212 Rodovia Abrão Assed Km 53 Zip Code 14097 500 Ribeirão Preto SP Brazil ...

Страница 11: ...ipment Safety symbols Located in risk areas and on its identification tag Installation instructions can be found in the service manual accessible only to authorized technicians The equipment must be transported and stored observing the following Handle carefully to avoid falls excessive vibrations and impacts The arrows on the packaging must be pointing upwards To handle the package as a single un...

Страница 12: ...r treatment The equipment must be operated only by qualified health professionals To operate the equipment operating personnel must Read and understand the user manual Be familiar with the basic structure and functions of this equipment Be familiar with the emergency situation protocols for this equipment Be able to recognize irregularities in the operation of the equipment and implement the appro...

Страница 13: ...ording to the instructions contained in this manual Do not unplug the cable or other connections unnecessarily Do not modify any part of the equipment If the equipment shows any abnormality check if the problem is included in any item listed in the Problem diagnosis topic of this user manual If it is not possible to solve the problem turn off the equipment and contact an Alliage Authorized Service...

Страница 14: ...n use To prevent environmental contamination the disposal of waste and consumables must follow the usual procedure for biomedical waste Biomedical waste encompasses non acute materials that may cause disease or suspicion of harboring pathogenic organisms that must be stored in a yellow bag properly labeled with a biohazard symbol stored in a puncture resistant watertight container until collection...

Страница 15: ...15 3 SYSTEM GENERAL DESCRIPTION Alliage S A Industrias Médico Odontológico Telephone 55 16 3512 1212 Rodovia Abrão Assed Km 53 Zip Code 14097 500 Ribeirão Preto SP Brazil ...

Страница 16: ...sign 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 Optical mirror protector in sturdy and transparent material protecting the mirror completely The LED is a light emitting diode that is a...

Страница 17: ... not have a degree of visual imperfection for reading or seeing and an average degree of recent memory impairment not being clearly able to perform the activities and functions of the product correctly in the profession The user needs to be a healthcare professional that has been qualified and trained to perform the activities functions frequently used in the application of the Dental Light and it...

Страница 18: ...T COMPONENTS 3 3 1 Light 01 Switch Shaft On Off 02 Multi sided glass mirror 03 Protective cover 04 Handles 05 LED Heatsink 06 Led lamp 07 Hinged arm 07 02 05 03 06 01 04 Optional items Subject to commercial availability ...

Страница 19: ... allows the fixation of the Light in offices with 38mm column Articulated arm double bench articulated arm Articulated arm with orbital movement Simple bench articulated arm Support for floor cei ling coupling allows the installation of the articulated arm Optional items Subject to commercial availability ...

Страница 20: ...lation In order to meet safety standards do not operate non medical equipment such as personal computers within the patient s area Outside the patient s area the presence of non medical equipment is acceptable provided that approved and certified computer equipment is used Computer equipment must be CE approved and must comply with CE 60950 1 2005 AMD1 2009 AMD2 2013 and low voltage 2014 35 EU and...

Страница 21: ...21 4 OPERATION Alliage S A Industrias Médico Odontológico Telephone 55 16 3512 1212 Rodovia Abrão Assed Km 53 Zip Code 14097 500 Ribeirão Preto SP Brazil ...

Страница 22: ...r single intensity on off 01 02 Coupled to the chair with a 3 keys paddle To start the reflector push button 02 through the dental chair s control paddle and keep pressing it to change luminosity luminosity will gradually change To turn it off Press button 02 once more 02 02 Coupled to the chair with a Joystick paddle 7 keys Press and release the key 02 to turn the dental light on or off To switch...

Страница 23: ... to the chair with a Joystick paddle 5 keys To start the reflector push button 03 through the dental chair s control paddle and keep pressing it to change luminosity luminosity will gradually change To turn it off Press button 03 once more 03 Coupled to the chair with a Chip Blower paddle Features a multifunctional key for activating the reflector To start the Reflector at maximum luminosity press...

Страница 24: ...on the headstock 70cm of the operative field 08 When handling the equipment take care with the parts that could pinch fingers The movement of the headstock is made through the knob 08 totally ergonomic designed to provide absolute isolation ...

Страница 25: ...25 5 CLEANING DISINFECTION AND STERILIZATION Alliage S A Industrias Médico Odontológico Telephone 55 16 3512 1212 Rodovia Abrão Assed Km 53 Zip Code 14097 500 Ribeirão Preto SP Brazil ...

Страница 26: ...ese solutions may compromise the equipment s paint The cleaning and disinfection process must be performed at each patient change When starting the process check for visible dirt such as blood or saliva For cleaning use a clean soft cloth moistened with mild soap and then dry with a clean soft cloth or paper towel For the disinfection process of the equipment use disinfectant detergent foam that h...

Страница 27: ...27 6 PROBLEMS DIAGNOSTIC Alliage S A Industrias Médico Odontológico Telephone 55 16 3512 1212 Rodovia Abrão Assed Km 53 Zip Code 14097 500 Ribeirão Preto SP Brazil ...

Страница 28: ...e problem and or contact your representative Unforeseen events Probable Cause Solutions The light does not turn on Lack of energy Fuse blown LED blown Wait for power to be restored Turn off the chair power and request the presence of a Te chnician Request the presence of a technician If problems persist contact the Alliage Service Department ...

Страница 29: ...29 7 INSPECTION AND MAINTENANCE Alliage S A Industrias Médico Odontológico Telephone 55 16 3512 1212 Rodovia Abrão Assed Km 53 Zip Code 14097 500 Ribeirão Preto SP Brazil ...

Страница 30: ...kept with the equipment In addition to the annual inspection in order to ensure a long durability and the good operation of your equipment it is important to carry out preventive maintenance for a maximum period of three 3 years Please contact the Alliage Service Department about our periodic review and preventive maintenance program All instructions for using the equipment as intended are provide...

Страница 31: ...ection and anchoring information No maintenance or services can be provided to the equipment or any of its parts during use with a patient The equipment contains parts under high voltage Risk of electric shock Turn off the main switch before servicing Moving parts can cut or crush The service manual is only available for Authorized Technical Assistance Alliage declares that the provision of circui...

Страница 32: ...as otherwise they will not be covered by the warranty If you need to request electrical diagrams and or specification of components that is not stated in the user s manual use the Alliage Customer Service to make the request Telephone 55 16 3512 1212 Address Rodovia Abrão Assed Km 53 Recreio Anhanguera Ribeirão Preto SP Brazil Zip Code 14097 500 ...

Страница 33: ...33 8 WARRANTY Alliage S A Industrias Médico Odontológico Telephone 55 16 3512 1212 Rodovia Abrão Assed Km 53 Zip Code 14097 500 Ribeirão Preto SP Brazil ...

Страница 34: ... twelve months counting from the date of the invoice issuance for the customer first owner until the date of installation This warranty applies to defects in parts raw materials and the manufacture of hardware products In the event of defects occurring and reported during the warranty period replacement parts and labor will be provided to replace items covered by the warranty THE MANUFACTURER IS N...

Страница 35: ...35 9 RULES AND REGULATIONS Alliage S A Industrias Médico Odontológico Telephone 55 16 3512 1212 Rodovia Abrão Assed Km 53 Zip Code 14097 500 Ribeirão Preto SP Brazil ...

Страница 36: ... to healthcare products IEC 60601 1 9 2014 Medical electrical equipment Part 1 9 General requirements for basic safety and essential performance Collateral standard Requirements for environmentally conscious design IEC 62304 2006 Medical device software Software lifecycle processes ISO 9680 2014 Operating lights ISO 7494 1 2018 Dentistry Dental units Part 1 General requirements and test methods IS...

Страница 37: ...37 10 TECHNICAL SPECIFICATIONS Alliage S A Industrias Médico Odontológico Telephone 55 16 3512 1212 Rodovia Abrão Assed Km 53 Zip Code 14097 500 Ribeirão Preto SP Brazil ...

Страница 38: ...Against Electric Shock Class I Protection Against Harmful Water Penetration IP00 Product not protected against harmful penetration of water and particulate material Degree of safety of application in the presence of a flammable anesthetic mixture with air oxygen or nitrous oxide Unsuitable equipment Operation mode Continuous operation Power supply voltage from the chair 24 Vcc Power consumption fr...

Страница 39: ...e 85 RH Atmospheric pressure range 700 hPa to 1060 hPa 525 mmHg to 795 mmHg Environmental conditions for transport and storage Room temperature range for operation 10ºC to 35ºC Operating relative humidity range non condensing 75 RH Atmospheric pressure range 700 hPa to 1060 hPa 525 mmHg to 795 mmHg Operating altitude 2000 m Environmental conditions for installation and operation 10 4 LIGHT BEAM PR...

Страница 40: ...40 10 5 DENTAL LIGHT DIMENSIONS Conventional Arm Coupled to the chair ...

Страница 41: ...41 Floor ...

Страница 42: ...42 Simple bench ...

Страница 43: ...43 Double bench ...

Страница 44: ...44 11 ELECTROMAGNETIC COMPATIBILITY Alliage S A Industrias Médico Odontológico Telephone 55 16 3512 1212 Rodovia Abrão Assed Km 53 Zip Code 14097 500 Ribeirão Preto SP Brazil ...

Страница 45: ...romagnetic Environments guidelines Emissions of RF CISPR 11 Group 1 The Dental Light uses RF energy only for its internal functions Therefore its RF emissions are very low and are unlikely to cause any interference in nearby electronic equipment Emissions of RF CISPR 11 Class A The Dental Light is suitable for use in all facilities except domestic ones and those directly connected to the public lo...

Страница 46: ...uency 1 kV 100 kHz repetition frequency Outbreak line line IEC 61000 4 5 0 5 kV 1 kV 0 5 kV 1 kV Outbreak line earth IEC 61000 4 5 0 5 kV 1 kV 2 kV 0 5 kV 1 kV 2 kV Conducted disturbances induced by RF fields IEC 61000 4 6 3 V 0 15 MHz 80 MHz 6V in ISM bands between 0 15 MHz and 80 MHz 80 AM to 1 kHz 3 V 0 15 MHz 80 MHz 6V in ISM bands between 0 15 MHz and 80 MHz 80 AM to 1 kHz Magnetic fields at ...

Страница 47: ...ance m Immunity assay le vel V m 385 380 390 TETRA 400 1 8 H z p u l s e modulation 1 8 0 3 27 450 430 470 GMRS 460 FRS 460 FM deviation of 5 kHz Sinusoidal 1kHz 2 0 3 28 710 704 787 LTE Band 13 17 217 Hz pulse modulation 0 2 0 3 9 745 7480 810 800 960 GSM 800 900 TETRA 800 IDEN 820 CDMA 850 LTE 5 Band 1 8 H z p u l s e modulation 2 0 3 28 870 930 1720 1700 1990 GSM 1800 CDMA 1900 GSM 1900 DECT LT...

Страница 48: ...eased emission or decreased electromagnetic immunity and result in improper operation Portable RF communication equipment including peripheral items such as antenna cables and external antennas should not be used within 30 cm away from any part of the equipment including cables specified by the manufacturer Otherwise performance degradation of this equipment may occur In order to maintain basic sa...

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