©2014 Welch Allyn, Inc.
MM 721356 Ver. C
1
Fiber
optic laryngoscope blade assemblies
Directions for use
Intended
About this
Warnings and
use
The
rigid laryngoscope is a device used to examine
placement of a tracheal
document
This directions for use applies to W elch Allyn reusable fiber optic laryngoscope blade
assemblies MacIntosh
6806X. Welch Allyn
Welch Allyn fiber optic laryngoscope handles 60813, 60814, 60815, 60713, and 60835.
cautions
WARNING: R
each use.
WARNING: The reprocessing procedure and the equipment and materials described
must be followed and conducted by persons trained and familiar
reprocessing.
WARNING: Consult cleaning and disinfecting agent manufacturer
proper preparation and use.
WARNING: Repeated
inspection procedures to assure damage has not occurred to the blade assembly.
WARNING: Only trained personnel shall use a laryngoscope for
WARNING: Do not reprocess laryngoscope blade assemblies used on
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
to patient injury. Any modification of this equipment voids the
WARNING: Personnel
appropriate personal protective equipment when handling
equipment.
WARNING:
eusable
Laryngoscope equipment is not suitable for use in intense
and visualize
tube.
REF:
6906X, English MacIntosh
reusable
fiber optic laryngoscop e blade assemblies may be used
fiber optic
reprocessing may
shall follow their facility policies and procedures and
laryngoscope blade
degrade
REF:
assemblies mu s t be reprocessed
elements of the device.
a patient’s airway
6921X, and Miller REF:
with
instructions
intubation.
product warranty.
potentially
medical device
for their
Follow
patients
equipment
contaminated
magnetic
with
can lead
wear
fields.
and
aid
with
after
CAUTION: Failure
CAUTION:
CAUTION:
glutaraldehyde
CAUTION:
Only use neutral pH
Only use neutral pH
disinfectants.
Do not use other cleaners or
to follow these instructions may cause damage to this device.
(6.0-8.0)
(6.0-8.0)
enzymatic type cleaners.
ortho-phthalahyde
disinfectants.
(OPA)
or
2
Directions for use
Welch Allyn fiberoptic laryngoscope
blade assemblies
Reprocessing
instructions
Reprocessing refers to procedures for cleaning and disinfection or sterilization of devices.
The fiber optic laryngoscope blade assemblies must be reprocessed prior to first use and
between each use using any of
• Cleaning
• Cleaning
• Cleaning
• Cleaning
• Cleaning
Welch Allyn has validated these instructions as being capable of preparing its laryngoscope
blade 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.
Cleaning instructions
Point of use: 1.
Preparation
decontamination:
Figure 1
the
following methods outlined in this
and cold solution high level
disinfection
and gravity autoclave sterilization
and pre-vacuum autoclave sterilization
and Steris® Amsco® V-PRO® low temperature sterilization
and
STERRAD® hydrogen peroxide gas plasma sterilization
Separate
blade assembly from handle and place the blade
assembly into suitable containment for
reprocessing. See Figure 1. Do not place the blade
assembly with sharp devices.
2. Prevent the blade assembly from drying per
practice (for example, use immersion, neutral pH
for
enzymatic
towel).
1. Disassemble the blade assembly per Figure 2.
pre-cleaner
or foam, or cover with a
2. Keep all blade components together to prevent loss.
3. Select a neutral pH en zymatic cleaner.
4.
Prepare
manufacturer
cleaning solution per cleaning
instructions.
Figure 2
document:
subsequent
solution
facility
moist