1.1
Purpose and scope
The purpose of these operating instructions is to provide information on the
ENBIO S and ENBIO PRO sterilizer. In particular, information concerning:
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Intended use
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Correct installation and settings
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Correct use and operation
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Safe and reliable operation
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Regular and proper maintenance and servicing
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Handling situations
1.2 Applicable legislation
The ENBIO S and ENBIO PRO sterilizers are designed and manufactured to meet the following requirements:
• EN 13060 standard "Small Steam Sterilizers" and related documents
• Directive 93/42 / EEC on medical devices
• Directive 2012/19 / EU on waste electrical and electronic equipment (WEEE)
• Law on Medical Devices
1.3. General description of the device
ENBIO S and ENBIO PRO are small steam sterilizers designed to sterilize medical devices with steam.
They have a hermetically sealed, heated chamber. The sterilized load is placed inside the chamber on a
special perforated tray. After closing the chamber, the user selects and starts the appropriate sterilization
program via a touch screen. Sterilization proper begins after the pre-vacuum phase. The steam generator
generates steam and introduces it into the chamber. This steam transfers its energy to the sterilized load.
Inside the chamber, the correct temperature and pressure, depending on the sterilization cycle selected,
are maintained for a specific period of time. After this time, the chamber is emptied of steam and the drying
cycle begins. When the sterilization process is complete, the device displays a summary information and
the result of the process to the user.
1.4. Purpose of the device
The ENBIO S and ENBIO PRO devices are small class B steam sterilizers in accordance with the EN 13060
standard; they are also classified as class IIb medical devices according to Annex IX of the Medical Devices
Directive 93/42 / EEC.
The devices are suitable for sterilizing loads for which steam sterilization is specified. The following medical
devices can be sterilized in the ENBIO S and ENBIO PRO: solid loads, small porous items, small porous
loads, full porous loads, simple hollow items, items with narrow clearance, multiple packages that can be
unpackaged or packaged (single- or multi-layer). The 134°C FAST process is dedicated exclusively to solid,
non-porous, simple instruments and dental instruments (e.g. scissors, handles, pliers, chisels, probes, etc.)
only unpackaged, non-textile.
The ENBIO S and ENBIO PRO devices can be used in primary health care practices, in dental practices,
and in treatment rooms. The sterilizers, which comply with the guidelines of the ISO 13060 standard, are
suitable for operation in the environment of other electrical medical devices.
The Enbio PRO sterilizer has a PRION program dedicated to one of the decontamination steps for items
suspected of having or may have come into contact with transmissible prion protein (e.g. Creutzfeldt-
Jakob disease, BSE, etc.). Detailed information and recommendations for infection control of transmissible
spongiform encephalopathies are provided in the document "WHO Infection Control Guidelines for
Transmissible Spongiform Encephalopathies - Report of a WHO consultation. (Geneva, Switzerland, 23-
26 March 1999)". It is the responsibility of the user of this device to follow these guidelines and any local/
national guidelines.
Non-medical use:
The ENBIO S and ENBIO PRO devices can also be used for non-medical applications, e.g. in beauty and
wellness salons, veterinary practices, cosmetic surgeries, tattoo studios, piercing studios and hairdressing
salons.
The devices are intended for professional use only by properly trained staff.
The ENBIO S and ENBIO PRO are not designed to sterilize liquids, pharmaceutical products,
biomedical waste or materials incompatible with steam sterilization. Processing such loads
may result in improper sterilization and/or damage to the autoclave and pose a risk to user/
patient safety.
1. Introduction
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