Use Restrictions - W&H Lexa PLUS Instructions For Use Manual

The information contained in this document is subject to change
without prior notice.

Use restrictions

INTENDED USE
For Medical Device in accordance with Regulation EU 2017/745:
The small steam sterilizers are intended for the sterilization of
invasive and non-invasive medical devices. The devices are
intended for professional use by trained people only.
For other purposes out of the scope of Regulation EU 2017/745:
The small steam sterilizers are intended for the sterilization of
devices other than invasive and non-invasive medical ones. The
small steam sterilizers are intended for the sterilization in veterinary
practices. They are also intended to be used for materials and
equipment which are likely to come into contact with blood or body
fluids, e.g. implements used by beauty therapists, tattooists, body
piercers and hairdressers.
The devices are intended for professional use by trained people
only.
For North American market:
Lexa PLUS is a dynamic-air-removal (pre-vacuum) table-top steam
sterilizer intended for use by a healthcare provider to sterilize
medical products by means of pressurized steam. It is suitable for
the sterilization of medical and dental instruments that are validated
Lexa PLUS | Instructions for Use | RIS-311 ENG Rev03 | 29/08/2022 | © W&H Sterilization Srl
to be sterilized by steam.
The Lexa PLUS has not been designed to sterilize liquid loads,
biomedical waste or materials not compatible with steam
sterilization. The processing of such loads may result in incomplete
sterilization and/or damage to the autoclave.
Introduction
9