Stryker Steri-Shield Flyte Manual De Instrucciones página 2

EN
Introduction
This instructions for use manual is the most
comprehensive source of information for the safe
and effective use of your product. This manual may
be used by in-service trainers, physicians, nurses,
and surgical technologists. Keep and consult this
reference manual during the life of the product.
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, especially safety
information, or in-service training, contact your
Stryker sales representative or call Stryker customer
service. Outside the US, contact your nearest Stryker
subsidiary.
NOTE: The user and/or patient should report
any serious product-related incident to both the
manufacturer and the Competent Authority of the
European Member State where the user and/or patient
is established.
Compliance Statements
The CE marking affixed to the equipment indicates
compliance with the following European Community
Regulations:
• Medical Device Regulation (EU) 2017/745
• Regulation (EU) 2016/425 - Personal Protective
Equipment (PPE)
This PPE has been EC-type examined by the
following notified body:
BSI Group The Netherlands B.V.
John M. Keynesplein 9
1066 EP Amsterdam, The Netherlands
BSI 2797
The lenses were developed and tested in accordance
with the requirements of BS EN 166: 2002.
Marking Definitions
EN166 S1F3
CODE DEFINITION
EN166 European Norm - Personal Eye Protection
Specification
S Code of Manufacturer, Stryker
1 Optical Class
F Mechanical Strength, Low Energy Impact
3 Protection against droplets and splashes
of liquids
Indications for Use
The Stryker Flyte Hoods are components of the
Stryker Personal Protection System and are intended
to protect the patient, healthcare personnel and
operating room personnel against contamination,
exposure of infectious bodily fluids, and the transfer
of microorganism and particulate material. The Flyte
Hoods are sterile, single use only.
2
Contraindications
None known.
Limitations of Use
WARNINGS:
• This personal protection system is not intended to
be used as a respiratory protection system.
• The lenses of this system provide limited
protection to the face from flying particles or the
splash of hazardous liquids. If these lenses are
worn over ophthalmic spectacles, impacts may be
transmitted. The lenses are not shatterproof.
• The hoods are not intended for use against
oily particulate such as paint mist, oil mist or
detergents.
• Avoid contact with open flame. The hood fabric
is not intended to be exposed to open flame and
may burn.
• The hoods are not intended for use in
atmospheres immediately dangerous to life or
health.
• The materials contained within this system are not
known allergens. However, if an allergic reaction
occurs, contact a physician.
For Use With
Flyte Hoods are components of the Stryker Flyte
System and are intended to be worn over any Stryker
Flyte Helmet.
DESCRIPTION
Flyte Helmet
Flyte Helmet with Fiber Optic
Headlight
Flyte Helmet with Battery
Powered Headlight
User/Patient Safety
WARNINGS:
• Only trained and experienced healthcare
professionals should use this equipment.
• Before using any system component, or any
component compatible with this system, read
and understand the instructions. Pay particular
attention to WARNING information. Become
familiar with the system components prior to use.
• The healthcare professional performing any
procedure is responsible for determining the
appropriateness of this equipment and the
specific technique used for each patient. Stryker,
as a manufacturer, does not recommend surgical
procedure or technique.
• Upon initial receipt and before use, visually
inspect the package for damage to confirm the
integrity of the sterile barrier. Do not use the
product if damage is apparent, the sterile barrier
is compromised, or the package is unintentionally
opened. If contamination is suspected, discard
the contaminated hood and use a new hood.
• Use only Stryker-approved components and
accessories, unless otherwise specified. DO NOT
modify any component or accessory.
• DO NOT use in the presence of flammable
anesthesia gases.
• DO NOT reuse, reprocess, or repackage this
device. This device is intended for a single use
only. DO NOT clean or re-sterilize this device.
Cleaning or re-sterilization may significantly affect
the filtration efficiency and result in tears in the
garment or other loss of mechanical integrity.
Failure to comply may lead to infection or cross-
infection and result in patient and/or healthcare
staff injury.
Description
The hoods with Peel Away lenses feature a three-
layer protective lens system. When the outer two
lenses become soiled, they can be peeled away to
reveal another sterile lens surface.
Symbol 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
REF
0408-600-000
0408-635-000
0408-645-000
TOP
Instructions
To Don the Hood (figures 1 to 6)
• ALWAYS wear the helmet and hood or toga as
a total system to obtain the required personal
protection.
• Before and during use, ALWAYS inspect the
equipment for rips, tears, cuts, or holes. ALWAYS
make sure seams and closing systems are secure
and function properly. Scratched or damaged
lenses should be replaced. DO NOT use the
equipment if damage is apparent.
• Per hospital protocol, ALWAYS use proper sterile
technique, especially when positioning the user's
arms to permit donning without contamination.
• DO NOT contaminate the exterior surface of the
hood during the removal of the user's face mask.
• ALWAYS follow current hospital protocol governing
the safe removal, handling, and disposal of
potential biohazard waste.
0408-800-740 Rev-AA
DEFINITION
General warning sign
Do not re-use
Lens Slot - Helmet Hook
Lens Magnet - Helmet
Magnet
This system DOES NOT
provide respiratory protection.
Top of product within wrap
WARNINGS:
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