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©2014 Welch Allyn, Inc.
MM 721462 Ver. C
Fiber optic laryngoscope handles
Directions for use
Intended use
The fiber optic laryngoscope handle is an accessory used with compatible rigid fiber optic laryngoscope blades which are used to examine and visualize a patient’s airway and aid placement of a tracheal tube.
About this document
This directions for use apply to Welch Allyn reusable fiber optic laryngoscope handles: 60813, 60814, 60815. Welch Allyn reusable fiber optic laryngoscope handles may be used with Welch Allyn fiber optic laryngoscope blades MacIntosh REF: 6906X, English MacIntosh REF: 6921X, and Miller REF: 6806X.
Warnings and cautions
WARNING: Reusable fiber optic laryngoscope handles must be reprocessed after each use.
WARNING: The reprocessing procedure and the equipment and materials described must be followed and conducted by persons trained and familiar with medical device reprocessing.
WARNING: Consult cleaning and disinfecting agent manufacturer instructions for their proper preparation and use.
WARNING: Repeated reprocessing may degrade elements of the handle. Follow inspection procedures to assure damage has not occurred to the handle.
WARNING: High level disinfection and/or sterilization are not achieved by these methods.
WARNING: Lamps, if left illuminated, could generate sufficient heat to cause burns
WARNING: Discard any component that shows evidence of damage or deterioration.
WARNING: Do not modify this equipment. Any modification of this equipment may lead to patient injury. Any modification of this equipment voids the product warranty.
WARNING: Personnel shall follow their facility policies and procedures and wear appropriate personal protective equipment when handling potentially contaminated equipment.
WARNING: Laryngoscope equipment is not suitable for use in intense magnetic fields
CAUTION: Only use lamp specified. Failure to follow these instructions may cause damage or poor performance of the handle.
CAUTION: If the device will be unused for several months or longer, remove the batteries prior to storing the device.
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Directions for use |
Welch Allyn fiber optic laryngoscope handles |
Reprocessing instructions
These reprocessing instructions refer to procedures for cleaning and intermediate level disinfection. Fiber optic laryngoscope handles must be reprocessed prior to first use and between each use using the following method as outlined in this document:
•Cleaning and intermediate level disinfection
Welch Allyn has validated the above instruction as being capable of preparing these laryngoscope handles for re-use. The user must ensure that the reprocessing as actually performed by the user's personnel, with the user's equipment and materials, achieves the desired result. This may require validation and routine monitoring of the user's actual process
NOTE: The main handle and bottom cap components are compatible with the disinfection solution and autoclave methods identified which are provided for facilities who wish to perform either method after cleaning and intermediate level disinfection.
Cleaning and intermediate level disinfection instructions
Point of use: |
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Separate blade assembly from handle and place handle |
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into suitable containment for subsequent reprocessing |
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(per figure 1). Do not place handle with sharp devices. |
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2. |
Prevent the handle from drying (i.e. wrap/cover in moist |
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germicidal wipe). |
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Preparation for |
1. |
Select an appropriate quaternary ammonium |
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decontamination: |
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isopropanol based germicidal cleaner labeled suitable |
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for use on healthcare equipment and capable |
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intermediate level disinfection. Reference EPA- |
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registered disinfectants: |
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http://www.epa.gov/oppad001/chemregindex.htm |
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Outside of the U.S., please consult applicable |
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regulatory body for equivalent quaternary ammonium |
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isopropanol germicidal cleaner. |
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2. |
Remove batteries and lamp cartridge (per figure 2). |
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Directions for use |
Welch Allyn fiber optic laryngoscope handles |
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Cleaning and |
1. Follow the germicidal wipe manufacturer’s instructions |
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intermediate level |
to clean all exposed surfaces of the main handle, end |
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disinfection: |
cap, and lamp cartridge. |
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2. If necessary, brush with a dry, soft-bristled brush and |
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re-wipe to loosen/remove excessive visible soil. |
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3. After all visible soil is removed, re-wipe to wet all |
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surfaces and allow adequate contact time for |
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disinfection as directed by the germicidal wipe |
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manufacturer. |
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CAUTION: Only use quaternary ammonium |
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isopropanol based germicidal wipes. |
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Drying: |
Allow components to air dry. |
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Maintenance, |
1. Inspect each component area (per figure 3) for damage or |
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Inspection and Testing |
deterioration. |
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WARNING: Discard any component that shows |
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evidence of damage or deterioration. |
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Contact Welch Allyn for component replacement. |
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2. Reassemble handle (per figure 4) with new or |
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batteries in known good condition. |
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3 . Attach handle to a clean and disinfected test blade |
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assembly in known working condition. Verify that: |
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• Blade assembly engages and locks onto handle. |
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• Blade assembly deploys into its locked position on |
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handle AND lamp illuminates. |
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• Light output is satisfactory. |
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If the lamp fails to light or output is low, check or |
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replace the lamp and/or batteries. |
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Storage |
Store handle per facility practice to allow device to remain |
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clean, dry, and ready for service. |
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End of reprocessing instructions for intermediate level disinfection.
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