Anthos A3 Plus, Руководство по эксплуатации, Страница: 4 / 50

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A3 PLUS
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OPERATING INSTRUCTION
1. Safety guidelines
• These instructions explain how to correctly use the following dental units:
A3 PLUS CONTINENTAL, A3 PLUS INTERNATIONAL
Carefully read and become familiar with the content of this manual before using the equipment.
• These instructions describe all the versions of the operating units with the maximum possible accessories, therefore not all the paragraphs are
applicable to the unit you have purchased.
• No part of this manual is to be reproduced, stored in a retrieval system or transmitted in any form or by any means, i.e. electronic, mechanical,
photocopying, translation or otherwise, without the prior written permission of CEFLA s.c..
• The information, technical specifications and illustrations contained in this publication are not binding.
CEFLA s.c. reserves the right to make technical improvements and changes without modifying the instructions contained herein.
• The manufacturer has a company policy of continual development. Although every effort is made to keep technical documentation up-to-date at
all times some of the instructions, specifications and figures given in this manual may slightly differ from the purchased product. The manufacturer
reserves the right to make changes without prior notice.
• The original version of this manual is written in Italian.
• This equipment is equipped with a device that prevents liquid back up.
1.1. Symbol definition
List of symbols used in this document to denote certain conditions:
1) Type of protection against direct and indirect contact: Class I.
Type of protection against direct and indirect contact: Type B.
2) WARNING!
Failure to observe may result in equipment damage or injury to the
user and/or patient.
3) "Consult the instruction manual".
Means that it is advisable to consult the instruction manual before
using that part of the device.
4) NOTE:
Identifies information that is especially important for the user and/or
assistant.
5) Earth ground. Functional earth connection.
6) Alternating current.
7) Part sterilised in a steam autoclave up to 135° C.
8) ON / OFF button.
9) "Refer to the instruction manual".
Means that for reasons of safety you need to consult the instruction
manual before using the device.
10) Open (a part of the unit).
11) Closed (a part of the unit).
12) Equipment in accordance with essential requirements of directive EEC
93/42 and subsequent changes (Class IIa equipment).
13) Equipment in accordance with essential requirements of directive
EEC 93/42 and subsequent changes (Class I medical equipment for
ordinary use).
14) Waste disposal symbol in accordance with Directive 2012/19/EU.
15) “Warning biological hazard”.
It provides information about possible risks of contamination deriving
from contact with fluids, storage of infected biological waste.
16) Manufacturer.
17) Month and year of constructions.
18) Apparatus serial number.
19) DVGW mark (quality assurance kitemark regarding supply of drinking
water).
20) Product/equipment identification code.
21) Do not push.
22) Foot crushing hazard.
23) Device equivalent to Class 2 light source.
1.2. Intended use
• The dental units A3 PLUS are Medical Devices intended for dental treatment.
• The instrument board may hold up to 6 instruments .
• The assistant’s board can hold 2 suction tubes and 3 instruments.
• This equipment must be used only by adequately trained personnel (doctors and paramedics).
• The device is intended for non-continuous operation (see the operating times of the individual parts in the dedicated sections).
• The device is classified as pollution degree 2.
• Overvoltage class: II.
1.2.1. Classification
• MEDICAL DEVICES classification
Classification of the dental unit in accordance with the indications given in annex IX of directive 93/42/EEC and subsequent changes: Class IIa
• ELECTRICAL MEDICAL EQUIPMENT classification
Classification of the dental unit in accordance with standard EN 60601-1 for safety of medical equipment: Class I - Type B.
• Reference standards: the dental units of the A3 PLUS series are designed in compliance with IEC 60601-1 3rd Ed. - 2007, IEC 60601-1-6 3rd
Ed. - 2010, IEC 62366 1st Ed. - 2007, IEC 80601-2-60 1st Ed. - 2012, IEC 60601-1-2 3rd Ed., ISO 6875 3rd Ed. - 2011, ISO 7494-1 2nd Ed. -
2011 and EN 1717 (type AA and AB) standards as far as water mains safety devices are concerned.
• Classification of RADIO DEVICES AND COMMUNICATION TERMINALS (only when the WIRELESS foot control is present)
Equipment classification according to Directive 99/05/EC Art.12: Class I .