Lyla | Instructions for Use | RIN-210 ENG Rev02 | 15/09/2022 | © W&H Sterilization Srl
9
Introduction
COPYRIGHT NOTICE
Copyright ©, W&H Sterilization Srl
All rights reserved in all countries.
All drawings, images and texts contained in this manual are the
property of the manufacturer. Even partial duplication of drawings,
images or text is prohibited.
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.
PROVIDED FEATURES
See "Sterilization cycles" on page 96 for the full list of key program
features, including sterilization time, temperature and recommended
load type.
USER QUALIFICATION
The users who may operate the sterilizer are the following.
User
qualification
Competences
Head of the
clinic/practice
Legally responsible for:
n
the efficiency of the hygiene protocol in place
n
the sterilization process
n
the operators' training and training documentation
n
the correct operation and maintenance of the equipment
Trained
operators
n
Regularly attend the training for operating and using the
sterilizer safely.
n
Use the sterilizer according to the Head of the
clinic/practice's instructions.
