Warnings And Cautions - Depuy Synthes VIPER Gebrauchsanweisung

inspected and sterilized prior to surgical use. These
instructions are provided to assist health care personnel in
the development of effective procedures for the processing
of non-sterile implants and reprocessing of reusable devices.
It is the responsibility of the facility to ensure that processing
is performed using the equipment, materials and competent
personnel at a designated processing area.
These instructions are provided for heat-resistant, critical
medical devices, unless otherwise noted on specific product
inserts. Product specific inserts are given priority over these
instructions. This can include heat-sensitive devices and
certain power (air- or electric-driven) tool designs that are
provided with specific cleaning and sterilization instructions.
Consult the product specific instructions for processing in
these cases.
DePuy Synthes Instruments do not have an indefinite
functional life. All reusable instruments are subjected to
repeated stresses related to surgical use, routine cleaning,
and sterilization processes. Instruments should be carefully
inspected before each use to ensure that they are functional.
Scratches, dents or other damage can result in instrument
breakage or tissue injury.
DePuy Synthes provides sterile and non-sterile
implants. These instructions do not apply to single-
use devices. Sterile, single use implants must not
be reused or reprocessed. Sterile implants are labelled as
single use and have not been validated for processing. Non-
sterile implants must be processed prior to use in accordance
with these processing instructions. They must be discarded
following patient use.
Manufacturer Contact
For local contact information, visit www.depuysynthes.com or
contact your local sales representative.
SYMBOLS

Warnings and Cautions

These instructions are provided for the processing of
heat-resistant, immersible, critical medical devices, unless
otherwise noted on specific product inserts. Product specific
inserts are given priority over these instructions. This can
include heat-sensitive devices and certain power (air- or
electric-driven) tool designs that are provided with specific
cleaning and sterilization instructions. Consult the product
specific instructions for processing in these cases.
The instructions provided are given as guidance for medical
device processing and have been validated by the manufac-
turer. It is the responsibility of the healthcare facility to ensure
that processing is performed using the required equipment,
materials and personnel at a defined processing area. This
will include the handling of devices during transportation,
processing and storage prior to surgical use.
Those using these instructions should be qualified personnel
with documented training and competency in accordance with
local procedures, guidelines, and standards.
Surgically used instruments can be considered biohazard
and facilities should ensure that transport and handling
procedures comply with local regulations and guidelines.
Sterile, single use implants must not be reused or
reprocessed. Sterile implants are labelled as single use and
have not been validated for reprocessing.
Non-sterile implants must be processed prior to use in
accordance with these processing instructions. They must be
discarded following patient use.
Reusable, non-sterile surgical instruments are required to be
cleaned, inspected and sterilized prior to surgical use.
Care should be taken in the handling and cleaning of sharp
devices.
All devices must be thoroughly cleaned and inspected prior
to sterilization. Long, narrow lumens, blind holes, moving
and intricate parts require particular attention during cleaning
and inspection. During cleaning, only use detergents that
are labelled for use on medical devices and in accordance
with the manufacturer's instructions. Cleaning agents with
a used dilution pH of within 7 – 9 are recommended. Highly
alkaline conditions (pH>10) can damage components /
devices, in particular aluminum materials. Do not use saline,
environmental disinfection (including chlorine solutions)
or surgical antiseptics (such as iodine- or chlorhexidine-
containing products). Do not use a cleaning aid that can
damage the surface of instruments such as steel wool,
abrasive cleaners or wire brushes.
Instruments should be carefully inspected before each use
to ensure that they are functional. Scratches, dents or other
damage can result in instrument breakage or tissue injury.
Instruments must be cleaned separately from instrument trays
and cases. Instrument trays and cases are designed as an
organizational tool in preparation for sterilization, storage and
surgical use. Non-sterile implant sets may be processed in
their trays provided
Automated equipment, including washer-disinfectors and
steam sterilizers must be installed, maintained and operated
in accordance with manufacturer's instructions.
Do not exceed 140°C (284°F) during reprocessing steps.
For patients with, or suspected with, Creutzfeldt-Jakob
disease (CJD), variant CJD or other transmissible
spongiform encephalopathy (TSE) and related infections,
it is recommended to treat the patient using single-use
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