Important Safety Instructions
12
BA_Elmasteam_8_Vers.07.2016
© Elma Schmidbauer GmbH
2.4
Information when Utilising as a Medical Device
The products of the Elmasteam 8 med Series are intended for
cleaning hard to reach areas on medical instruments. This
cleaning is NOT a replacement for the subsequent cleaning,
disinfection or sterilisation in automated standard processes (e.g.
RDG or autoclave).
The device is particularly suitable for the cleaning of:
•
Joint areas of joint instruments
•
Fluted surfaces of e.g. forceps
•
Cleaning of melted fabric material on electro-surgical
instruments (e.g. bipolar forceps)
•
Cleaning of drills and cutters (drilling/milling heads with e.g.
residual tissue, bone meal)
•
Pre-cleaning of the lumen of hollow instruments.
The utilisation of Elmasteam has to be previously clarified with the
instrument manufacturer for temperature-sensitive instruments.
(Steam temperature
Chapter 3.4 Technical Data
)
The plastic-coated portion of the instrument must not be processed
with the device (risk of detachment) when pre-cleaning of
instruments made of composite material (e.g. steel-plastic in
bipolar forceps).
Steam cleaner for manual pre-cleaning or treatment of
instruments.
Only medical devices that are approved and reusable for
reprocessing must be cleaned (refer to the information from the
medical device manufacturer in accordance with EN ISO 17664).
The operation must only be performed by trained personnel and
not by children. Operating and equipment must be executed in
accordance with the conditions and the media defined in the
operating instructions. The service intervals as well as regional
regulations for inspecting the device must be adhered to.
Instruments must be disinfected in accordance with the
instructions from the instrument manufacturer prior to processing
and treating with the device e.g. as in disinfectant solution
according to the VAH list.
INFORMATION
Safety Precautions for the User!
The exact adherence to all safety regulations must be observed,
in particular the wearing of suitable protective clothing (jacket,
cap, heat resistant gloves, a mask and face shield (visor)).
Intended Use
Intended Use
Disinfect the
Instruments before
Cleaning
Safety Precautions
for the User
