Safety Guidelines; Symbol Defi Nition; Intended Use; Classifi Cation - CASTELLINI SKEMA 6 CART Instructions De Service

1. Safety guidelines

• These instructions describe how to use the
Carefully read and become familiar with the content of this manual before using the equipment.
• All versions of the SKEMA 6 fully loaded dental units are described herein therefore not all the paragraphs may pertain to the equipment 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 CASTELLINI S.p.A.
• The information, technical specifi cations and illustrations contained in this publication are not binding.
CASTELLINI S.p.A 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, specifi cations and fi gures 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 defi nition
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) OPERATING INSTRUCTIONS:
This symbol indicates that the user should read and become familiar
with the content of the User's manual before attempting to use the
relative part of the equipment.
4) NOTE:
Identifi es information that is especially important for the user and/or
assistant.
5) Earth ground. Functional earth connection.
6) Alternating current.
7) Part sterilized in autoclave.
8) Equipment on.
9) Equipment off.
10) On (a part of the apparatus).
11) Off (a part of the apparatus).
12) Equipment in accordance with essential requirements of directive EEC
93/42 and subsequent changes (Class II equipment).
13) Equipment in accordance with essential requirements of directive EEC
93/42 and subsequent changes .
14) Symbol indicating separate collection for electrical and electronic
equipment in compliance with Directives 2002/95/ EC, 2002/96/ EC e
2003/108/ EC.
15) "Warning biological hazard".
It provides information about possible risks of contamination deriving
from contact with fl uids, 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 identifi cation code.

1.2. Intended use

• The SKEMA line 6, SKEMA 6 and SKEMA 6 CP model operatory units are medical devices intended for dental treatment.
• The instrument board may hold up to 6 instruments.
• The assistant's board may be equipped with 2 suction tubes and 3 instruments.
• This equipment must be used only by adequately trained personnel (doctors and paramedics).
• Equipment designed for continuous operation with intermittent loads (see the times for the individual parts in the dedicated sections).
1.2.1. Classifi cation
• MEDICAL DEVICES classifi cation
Classifi cation of the dental unit in accordance with the indications given in annex IX of directive 93/42 and subsequent changes/EEC: Class IIa.
• ELECTRICAL MEDICAL EQUIPMENT classifi cation
Classifi cation of the dental unit in accordance with standard EN 60601-1 for safety of medical equipment: Class I - Type B.
• Reference standards
SKEMA 6 series operatory units are designed and constructed in compliance with CEI EN 60601-1, CEI EN 60601-1-2, ISO 7494, ISO 6875 and
EN 1717 (type AA and AB) standards as far as the water mains safety devices are concerned.
• Classifi cation of RADIO DEVICES AND COMMUNICATION TERMINALS (only when the WIRELESS foot control is present)
Equipment classifi cation according to Directive 99/05/EC Art.12: Class I.
86 86 86 GB EN
SKEMA 6
- OPERATING INSTRUCTION
SKEMA 6 series dental units correctly.
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