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MM 721358 Ver. C

Standard

laryngoscope blade assemblies

Directions for use

Intended

use

The

rigid laryngoscope is a device used to examine

and visualize

a patient’s airway

and

aid

placement of a tracheal

tube.

About this

document

This directions for use applies to Welch Allyn reusable standard laryngoscope blade

assemblies MacIntosh

REF:

6904X, English MacIntosh

REF:

6924X, and Miller REF:

6804X and REF 68470. Welch Allyn

reusable standard

laryngoscope blade assemblies may be

used

with

Welch Allyn standard laryngoscope handles 60200, 60300, 60400, 60305, and 60710.

Warnings and

cautions

WARNING: R

eusable

fiber optic

laryngoscope blade

assemblies 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 device.

inspection

procedures to assure damage has not occurred to the blade assembly.

WARNING: Only trained personnel shall use a laryngoscope for

intubation.

WARNING: Do not reprocess laryngoscope blade assemblies used on

patients

with

Creutzfeldt-Jakob disease. These instruments should be discarded.

WARNING: Discard any component that shows evidence of damage or deterioration.

WARNING: Do not modify this equipment. Any modification of this

equipment

can 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.

WARNING: Lamps if left illuminated, could generate sufficient heat to cause burns.

CAUTION: Only use lamps specified. Failure

to follow these instructions may cause damage

or poor performance of this device.

CAUTION:

Only use neutral pH

(6.0-8.0)

enzymatic type cleaners.

CAUTION:

Only use neutral pH

(6.0-8.0)

ortho-phthalahyde

(OPA)

or glutaraldehyde

disinfectants.

CAUTION:

Do not use other cleaners or

disinfectants.

CAUTION:

Do not remove lamp during reprocessing. Damage to device could occur.

CAUTION:

REF 68470 is not compatible with any sterilization process.

Summary of content (6 pages)

PAGE 1
©2014 Welch Allyn, Inc. MM 721358 Ver. C Standard laryngoscope blade assemblies Directions for use Intended use The rigid laryngoscope is a device used to examine and visualize a patient’s airway and aid placement of a tracheal tube. About this document This directions for use applies to Welch Allyn reusable standard laryngoscope blade assemblies MacIntosh REF: 6904X, English MacIntosh REF: 6924X, and Miller REF: 6804X and REF 68470.
PAGE 2
Directions for use Welch Allyn standard laryngoscope blade assemblies Reprocessing instructions Reprocessing refers to procedures for cleaning and disinfection or sterilization of devices.
PAGE 3
Directions for use Welch Allyn standard laryngoscope blade assemblies Manual cleaning process: 3 1. Immerse all components in a neutral pH enzymatic cleaning solution as directed by solution manufacturer’s instructions. 2. While components are immersed in the cleaning solution, use a soft-bristled brush to clean all component surfaces (the blade, retaining screw, and light carrier) until all visible contamination is removed. 3.
PAGE 4
Directions for use Welch Allyn standard laryngoscope blade assemblies Cold solution high level disinfection instructions Preparation for decontamination: 1. Select a neutral pH ortho-phthalahyde (OPA) or glutaraldehyde disinfectant. 2. Prepare disinfecting solutions per disinfectant solution manufacturer instructions. Cold solution high level disinfection: 1. Disassemble the blade per Figure 2. 2.
PAGE 5
Directions for use Welch Allyn standard laryngoscope blade assemblies 5 Pre-vacuum autoclave sterilization Packaging: Package the blade assembly in an appropriately sized single pouch or in a wrap labeled as appropriate for the pre-vacuum autoclave exposure parameters outlined below; package the blade assembly per facility practice in preparation for autoclave. Pre-vacuum autoclave sterilization: Follow equipment manufacturer and facility procedures in the set-up and operation of autoclave equipment.
PAGE 6
Directions for use Welch Allyn standard laryngoscope blade assemblies Maintenance instructions Replace the lamp and/or light assembly (REF: 6904X, 6924X, and 6804X) CAUTION: Use only lamps specified to ensure proper performance. Use lamp REF 04700 for: 69041, 2, 69241, 2, 68045, 0, 1, and 68470 blade/light assemblies Use lamp REF 04800 for: 69043, 4, 69243, 4, and 68042, 3, 4 blade/light assemblies 1. 2. 3. 4. 5. 6. 7. Remove the locking screw by rotating counterclockwise with a standard screwdriver.