Use Restrictions - W&H Lara RIS-311 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.
Lara XL | Instructions for Use | RIS-311 ENG Rev02 | 01/06/2022 | © W&H Sterilization Srl
USER QUALIFICATION
The users who may operate the sterilizer are the following.
User
Competences
qualification
Head of the Legally responsible for:
the efficiency of the hygiene protocol in place
clinic/practice
n
the sterilization process
n
the operators' training and training documentation
n
the correct operation and maintenance of the equipment
n
Trained Regularly attend the training for operating and using the
n
operators sterilizer safely.
Use the sterilizer according to the Head of the
n
clinic/practice's instructions.
Introduction
9