TAU STERIL s.n.c
Via Gorizia, 6/a
Fino Mornasco ( CO )
Instructions for Use
TAU CLAVE 3000 Fractionated Vacuum
Data: 30.03.15
Pag. 3 di 14
Rev. 3
N° 1
3
This document may not be reproduced in partial form without the authorization of TAU STERIL.
1
Warnings
Tau Clave 3000 Fractionated Vacuum is an Autoclave. Carefully clean the sterilization chamber and the instruments to
sterilize. USE ONLY DEMINERALIZED WATER.
2
Introduction:
2.1
Normative References
The autoclave Tau Clave 3000 Fractionated Vacuum is conforming to the essential requirements of the Directives of the
Council: Medical devices 93/42/CEE and S.M.I., class II b it is conforming besides to the national norms that are translated in
the harmonized norms:
EN 13060 ( Class S )
EN 61010-1
EN 61010-2-040
EN 61326 – 1
IEC 62304
EN 60601-1-6
IEC 62366
UNI CEI EN ISO 14971
The autoclave Tau 3000 Fractionated Vacuum complies with RoHS 2011/65 / EU of the European Parliament and of the
Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment.
2.2
Expected use of materials to sterilize
The equipment is used to sterilize surgical instruments in the medical-paramedical sector. The materials to be sterilized must
withstand
operating temperatures ranging from 105°C to 134°C.
Do not load toxic materials into the autoclave
.
TAU STERIL shall not assume any responsibility in this respect.
2.3
Manufacturer’s Responsibility
The equipment is manufactured in compliance with European regulations.
The use of this equipment is restricted to the functions for which it was originally designed and manufactured.
The user shall
be responsible in case of any possible risks and dangers caused by an improper use of the autoclave.
The product warranty is of twelve months starting from the date of purchase.
