4
BEFORE USE
Please read these Operating Instructions carefully as they
explain all the most important details and procedures. Please
pay special attention to the safety precautions.
Always keep these Instructions close at hand.
These Instructions are only applicable to the equipment
they were delivered with.
To prevent injury to persons or damage to property, please
observe the corresponding directives and symbols.
This instruction follows the recommendations of RKI Robert
Koch Institut, Germany.
Translations in this manual are based on the English version.
Thus the English text will be referred to in case of discrepancy.
CLEANING AND DISINFECTION FOR DEVICES AND HANDPIECE CORDS
The following instructions have been validated for all reusable products
1
of EMS dental devices. It remains the responsibility
of the processor to ensure that the processing, as actually performed using the equipment, materials and personnel in the
processing facility, achieves the desired result. This requires validation and/or validation and routine monitoring of the process.
Likewise any deviation by the processor from the instructions provided should be properly evaluated for effectiveness and
potential adverse effects.
AIRFLOW
®
and
PIEZON
®
devices
Handy
PIEZON
®
Kit on
your unit
CLEAN AND DISINFECT
Use a cleaning and disinfecting wipe (less than 35%
alcohol) that complies with the standards applicable in
the country.
Follow carefully the instructions provided by the
wipes manufacturer.
DO NOT use CaviWipes™ or Advantaclear wipes. It
damages EMS products.
INTRODUCTION
EMS recommends compliance with cleaning, disinfection,
packaging for sterilization and sterilization procedures
according to ISO 17664.
Always report adverse events related to device
reprocessing directly to EMS.
Products must be cleaned, disinfected and, if applicable,
sterilized prior to rst use. Do not reprocess the products over
the authorized number of sterilization cycles. To replace, refer
to the “Service life” section of these Instructions.
Concentrations and contact times specied by the
manufacturer of the cleaning and disinfection agent must be
observed.
Remember that sterilization mustn't be achieved unless
assembly components are cleaned and disinfected rst.
If parts of these instructions are not clear or seem to be
inadequate, do not hesitate to contact/inform EMS.
Users shall also observe any legal requirements applicable in their country as well as the hygiene regulations in effect
at the hospital or clinic.
This applies especially with regard to additional requirements for the inactivation of prions.
SERVICE LIFE
The products have been designed for a large number of
sterilization cycles. The materials used in their manufacture
were selected accordingly. However, with every renewed
preparation for use, thermal and chemical stresses will result
in ageing of the products.
Always replace products that present signs of wear or
early degradation, regardless of the number of sterilization
cycles left unused.
DO NOT expose the products to temperature exceeding
138°C.
EMS handpieces must not be lubricated or otherwise
exposed to oil whether directly or indirectly.
Lifetime : see product's Instructions for Use.
SYMBOLS
Caution / Danger - Risk of property damage or injury Refer to instruction manual
Please note - Useful additional information and hints Sterilizable at up to 135°C in the autoclave
Prohibited Suitable for thermal disinfection
Wear personal protective equipment
Required time - Abbreviations used: min (minute) ;
s (second)
1 Hereinafter referred to as "products".
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