Introduction; Purpose; Applicable Legal Acts; Purpose Of The Device - ENBIO S Mode D'emploi

1. INTRODUCTION

1.1 Purpose

The purpose of this user manual is to provide information about the ENBIO
steriliser and ensure:
• proper installation and setup,
• optimum use,
• safe and reliable operation,
• regular and correct maintenance and servicing in accordance with re-
quirements.

1.2 Applicable legal acts

The ENBIO S / ENBIO PRO meet the following legal requirements:
• The sterilisers have been designed and manufactured in accordance with
the EN 13060 standard.
• The sterilisers meet the essential requirements of Directive 93/42/EEC and
the Medical Products act and have the status of medical product.
• DIRECTIVE 2012/19/EU OF THE EUROPEAN PARLIAMENT AND OF THE
COUNCIL of 4 July 2012 on waste electrical and electronic equipment
(WEEE)

1.3 Purpose of the device

The ENBIO S / ENBIO PRO is a small class B and S steam sterilisers according
to standard EN 13060, classified as a class IIb medical product according
to annex IX to Directive 93/42/EEC on medical products, and the Regula-
tion of the Minister of Health dated 5 November 2010 on classification of
medical products.
According to the classification under standard 13060, the ENBIO device
can sterilise the following medical products: solid charges, small porous
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objects, small porous charges, full porous charges, simple recessed items,
items with a narrow gap, multiple use packs that may be non-packaged or
packaged (in one or more layers). The 134 FAST process is dedicated
to solid, non-porous, simple instruments and dental tools (eg scis-
sors, handles, pliers, chisels, probes, etc.) exclusively unpacked, not
textile. ENBIO S / ENBIO PRO can be used in primary healthcare practices,
dentistic practices, and in operating rooms.
The steriliser is suitable for use in the vicinity of other powered medical
products.
The ENBIO S / ENBIO PRO may not be used to sterilise liquids, biomedical
waste or pharmaceutical products. The device is intended for professional
use by properly trained staff only.
Extra-medical applications:
The ENBIO S / ENBIO PRO can also be used for extra-medical applications,
such as beautician and biological regeneration studios, and in veterinary
practices, tattoo artist and piercing studios, hair stylist salons.
The ENBIO device may not be used to sterilise liquids, biomedical
waste or pharmaceutical products.
The device is intended for professional use by properly trained staff only.

1.4 Symbols used on the device

This symbol is located on the front of the device, on the up-
per part of the drawer front. It is recommended to maintain
caution due to high temperature within and around the
operating chamber.