Warnings And Cautions - Depuy Synthes EXPEDIUM SFX Handbuch

packaging, using aseptic technique, only after the correct size
has been determined.
PRECAUTION: Do not use implants if the condition of the
package and/or labeling indicates a chance that the devices
may not be sterile.
Implants supplied sterilized from the manufacturer must not
be re-sterilized.
Non-sterile Implants
Instructions for Processing
Medical Devices
Non-sterile Implants, and Reusable Instruments,
Instrument Trays and Cases
Introduction
DePuy Synthes non-sterile implants and reusable instruments
are critical medical devices. These devices must be cleaned,
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. Sterile, single use implants must not be
reprocessed or reused. Non-sterile implants must
be sterilized prior to use in accordance with these processing
instructions. They may be subjected to reprocessing in
accordance with these processing instructions, but must be
discarded following direct patient contact or use.
Manufacturer Contact
For local contact information, visit www.depuysynthes.com or
contact your local sales representative.

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 reprocessed or
reused. 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 may be
subjected to reprocessing in accordance with these processing
instructions, but they must be discarded following direct
patient contact or 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, such
as aluminium 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.
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