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Important information!
The reprocessing instructions in accord-
ance with FDA Guidance "Reprocessing
Medical Devices in Health Care Settings -
Validation Methods and Labeling" have
been independently tested by the manu-
facturer for the preparation of the device
and its components for their reuse.
The person conducting the reprocessing
is responsible for ensuring that the
reprocessing is performed using equip-
ment, materials and personnel that attains
the desired results. This requires valida-
tion and routine monitoring of the reproc-
essing process. Any negative consequen-
ces resulting from deviation from these
instructions by the person conducting the
reprocessing are the responsibility of the
member of staff performing the reproc-
essing.
Frequent reprocessing has little effect on
the components of the device. The end of
the product life cycle is mainly influenced
by the amount of wear and tear or dam-
age resulting from its use.
The use of soiled, contaminated and
damaged components is at the sole
responsibility of the person performing the
reprocessing and the operator.
The validation of the reprocessing method was
performed based on the assumption that, in the
worst case scenario, a hygienic protective cover
could be damaged while it is being applied or
during use.
In accordance with IEC 80601-2-60, the applied
part of the SensorX is limited to a length of 80
mm, starting at the sensor edge, opposite from
the cable. For this reason, only the applied part
was considered during the validation of the
reprocessing method.
The reprocessing procedure was validated as fol-
lows:
– Pre-cleaning
– Lint-free disposable wipe
– Manual cleaning
– Monarch disinfection wipes
(Air Techniques)
– Manual disinfection
– Monarch disinfection wipes
(Air Techniques)
2121100020L29 2101V007
11.3
General information
Comply with all national directives, standards
❯
and specifications for the cleaning, disinfection
and sterilization of medical devices as well as
the specific specifications for dental practices
and clinics.
When selecting the cleaning and disinfectant
❯
agents to be used, the information provided
(see "11.5 Manual cleaning, disinfection and
drying") must be followed.
Comply with the concentrations, temperatures,
❯
residence times and post-rinsing specifications
issued by the manufacturer of the cleaning
agent and disinfectant.
Only use cleaning agents that are non-fixing
❯
and aldehyde-free and display material com-
patibility with the product.
Only use disinfectants that are aldehyde-free
❯
and display material compatibility with the
product.
Only use freshly-produced solutions.
❯
Only use distilled or de-ionized water with a low
❯
bacterial count (at least drinking water quality)
that is free from facultatively pathogenic micro-
organisms (e.g. Legionella bacteria).
Use clean, dry, oil- and particle-free com-
❯
pressed air.
11.4
Preparation at the operating
location
Wear hand protection.
Wear eye protection.
Use a mask.
Wear protective clothing.
Clean the hygienic protective cover (with inte-
❯
grated sensor) with a disinfection wipe.
Carefully pull off the hygienic protective cover
❯
and discard it.
Clean the device for 1 minute with a lint-free
❯
disposable wipe soaked in cold tap water until
no more dirt or contamination can be seen.
Usage
EN-
US
27
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