Stryker Flyte 0408-600-000, Instructions For Use Manual

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EN 0408-600-705 Rev-AB
2 www.stryker.com
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, surgical technologists, and biomedical
equipment technicians.
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.
If additional information, especially safety information, or in-service training is
required, contact your Stryker sales representative or call Stryker customer
service.
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.
Trademarks not the property of Stryker Corporation are the property of their
respective owners.
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.B.
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 — S1663F
CODE DEFINITION
S Code of Manufacturer, Stryker
166 European Norm Standard - Personal Eye Protection Specification
3 Liquid Droplets
F Mechanical Strength, Low Energy Impact
Indications For Use
The Stryker Flyte Helmets are surgical devices that pull in and circulate fresh air
throughout the helmet to aid user comfort.
Contraindications
None known.
Limitations of Use
WARNINGS:
• The surgical helmet is not intended to be used as a respiratory protection
device.
• The materials contained within this device are not known allergens. However, if
an allergic reaction occurs, contact a physician.
For Use With
Rechargeable Flyte Power Pack and the Flyte Power Cord. See
Accessories
section.
Description
In addition to pulling in and circulating fresh air throughout the surgical helmet,
each helmet has microphone and speaker capability. Stryker-approved dictation
recorders, MP3 players or other compatible communication devices may be
connected to the helmet via a communication cord.
User/Patient Safety
WARNINGS:
• Before using any component, or any component compatible with this
equipment, read and understand the instructions. Pay special attention to
WARNING information. Become familiar with the components prior to use.
• Only trained and experienced healthcare professionals should use this
equipment.
• Upon initial receipt and before each use, operate the equipment and inspect
each component for damage. DO NOT use any equipment if damage is
apparent or the inspection criteria are not met. See the
Inspection and Testing
section for inspection criteria.
• 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.
• DO NOT use this equipment in areas in which flammable anesthetics or
flammable agents are mixed with air, oxygen or nitrous oxide.
• Take special precautions regarding electromagnetic compatibility (EMC) when
using medical electrical equipment like the Flyte helmet. Install and place the
helmet into service according to the EMC information in this manual. Portable
and mobile radio frequency (RF) equipment, such as wireless phones, can
affect the function of the helmet. See the
Specifications section.
• DO NOT stack or place equipment adjacent to the product. If such a
configuration is necessary, observe the configuration to ensure that
electromagnetic interference does not degrade performance.
• DO NOT use the product in a magnetic resonance imaging (MRI) environment.
Using the product in an MRI environment could affect the function of the
system.
Accessories
This section describes components that may be ordered to replace original
equipment that is damaged, worn, or must be replaced. This section may also
contain optional components used with the surgical helmet.
WARNINGS:
• Use only Stryker-approved components and accessories, including earphones
and dictation equipment, unless otherwise specified.
• Using other electronic components and accessories may result in increased
electromagnetic emissions or decreased electromagnetic immunity of the
equipment.
• DO NOT modify any component or accessory, unless otherwise specified.
• DO NOT reuse, reprocess, or repackage a single use device. A single use
device is intended for a 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 serious risk
of contamination and may compromise the structural integrity of the single use
device resulting in operational failure. Critical product information may be lost
if the single use device is re-packaged. Failure to comply may lead to infection
or cross-infection and result in patient and/or health care staff injury.
The following Stryker-approved accessories are sold separately:
DESCRIPTION REF
Flyte Lithium-Ion Extended Life Power Pack 0408-660-000
Flyte Comfort Pads – A set of five disposable pads are
installed in the inner helmet to provide additional comfort;
eight sets per case 0408-210-000
Flyte Helmet Power Cord 0408-600-300
Flyte Helmet Dictation Power Cord – When using a Stryker-
approved device such as a dictation recorder or MP3 player,
replace the power cord with a dictation power cord. 0408-605-300
SONY Earphone-Right 0400-615-600
SONY Earphone-Left 0400-615-610
PANASONIC Earphone-Right 0400-615-620
PANASONIC Earphone-Left 0400-615-630
NOTE: For a complete list of accessories, contact your Stryker sales
representative or call Stryker customer service. Outside the US, contact your
nearest Stryker subsidiary.