Stryker Sonopet 5450-800-278 Instrucciones De Uso página 3

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.
Audience
This manual is intended for in-service trainers, biomedical equipment
technicians, and central supply/sterile processing technicians.
Conventions
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.
Contact 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 Sonopet Sterilization and Assembly Tray is designed to
protect reusable medical devices during steam sterilization, storage and
transportation. The Sterilization and Assembly Tray must be wrapped in a
validated sterilization wrap prior to sterilization to maintain sterility or may also
be placed in a rigid container that does not require a validated wrap.
Contraindications
None.
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
The designated location for placement of the coiled
COIL CORD
HERE handpiece cord inside the tray.
DO NOT grasp the handpiece by hand to install or remove
the ultrasonic tip.
NOTE: Handpiece assembly instructions are displayed on the sterilization tray
lid. See the instructions for use supplied with the handpiece.
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Print Date: Feb 01, 2016 10:15:16 AM
0000033210, Rev. A Effective Date: Feb 1, 2016 9:04:17 AM
For Use With
The tray is intended for use with Stryker Sonopet Ultrasonic handpieces,
attachments, and accessories.
Description
The sterilization tray, otherwise known as a sterilization case, is designed
to hold medical instruments for sterilization, storage, transportation, aseptic
presentation of contents, and return of the contaminated items to the
decontamination area. The typical sterilization tray consists of a bottom or
base, a lid that is secured to the base by means of a latching mechanism,
and carrying handles. To permit sterilant penetration into the tray, there are
perforations in the base and lid. The tray may include an open basket(s) or
insert tray(s), placed inside, to hold the handpieces and accessories. The
sterilization tray must be completely enclosed in an validated sterilization wrap
to maintain sterility.
Safety Directives
WARNINGS:
• 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 use this equipment.
• Upon initial receipt and before each use, inspect each component for
damage. DO NOT use any equipment if damage is apparent or the
inspection criteria are not met. See the care instructions manual supplied
with the handpiece.
• 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.
Care Instructions
For general processing instructions, see the care instructions manual supplied
with the handpiece.
5450-800-700 Rev-A
www.stryker.com