Safety Directives; Indications For Use - Stryker 6102-450-000 Manual Del Usuario

EN
Introduction
This instructions for use manual contains information intended to
ensure the safe, effective and compliant use of your product. Keep
and consult this reference manual during the life of the product.
This manual is intended for in-service trainers, biomedical equipment
technicians, and central supply/sterile processing technicians.
The following conventions are used in this manual:
▪ A WARNING highlights a safety-related issue. ALWAYS comply
with this information to prevent patient and/or healthcare staff
injury.
▪ A CAUTION highlights a product reliability issue. ALWAYS comply
with this information to prevent product damage.
▪ A NOTE supplements and/or clarifies procedural information.
For additional information, including safety information, in-service
training, or current literature, contact your Stryker sales representative
or call Stryker customer service. Outside the US, contact your
nearest Stryker subsidiary.

Indications For Use

The Stryker Sterilization Case is designed to contain an insert tray
and protect reusable medical devices during steam sterilization,
storage and transportation. The Sterilization Case must be wrapped in
a validated sterilization wrap prior to sterilization to maintain sterility.
The Stryker Insert Tray is designed to provide a convenient holder
for reusable medical devices during automated washing and steam
sterilization. This Insert Tray may also be placed in a rigid container
that does not require a validated wrap.
Contraindications
None known.
Definitions
The symbols located on the equipment and/or labeling are defined
in this section or in the Symbol Definition Chart. See the Symbol
Definition Chart supplied with the equipment.
SYMBOL DEFINITION
General warning sign
2
For Use With
The tray is intended for use with Stryker System 6 handpieces and
attachments. The tray will accommodate a variety of handpiece and
attachment combinations.

Safety Directives

WARNINGS:
▪ Upon initial receipt and before each use, inspect each component
for damage. DO NOT use any equipment if damage is apparent.
▪ Before using this equipment, or any component compatible with
this equipment, read and understand the instructions for use. Pay
particular attention to safety information. Become familiar with the
equipment before use.
▪ Only individuals trained and experienced in the processing of
reusable medical devices should process this equipment.
▪ DO NOT reuse, reprocess, or repackage a device that is intended
for single use only.
- A single use device may not withstand chemical, chemical
vapor, or high temperature sterilization reprocessing.
- Design features may make cleaning difficult.
- Reuse may create a contamination risk and compromise
structural integrity resulting in operational failure or
fragmentation during use.
- Critical product information may be lost during repackaging.
Failure to comply may lead to infection or cross infection and
result in patient and/or healthcare staff injury.
6102-450-701 Rev-F
www.stryker.com