©2014 Welch Allyn, Inc.
MM 721358 Ver. C
1
Standard
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 standard l aryn goscope blade
assemblies MacIntosh
6804X and REF 68470. Welch Allyn
used
with
Welch Allyn standard laryngoscope handles 60200, 60300, 60400, 60305, and 60710.
cautions
WARNING: R
each use.
WARNING: The reprocessing procedure and the equipment and materials described must
be followed and cond ucted by persons trained and familiar
reprocessing.
WARNING: Consult cleaning and disinfecting agent manufacturer
proper preparation and use.
WARNING: Repeated
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
patient injury. Any modification of this equipment voids the
WARNING: Personnel
personal protective equipment when handling
WARNING:
WARNING: Lamps if left illuminated, could generate sufficient heat to cause burns.
CAUTION: Only use lamps specified. Failure
or poor performance of this device.
eusable
Laryngoscope equipment is not suitable for use in intense
and visualize
tube.
REF:
6904X, English MacIntosh
reusable sta n d a r d
fiber optic
reprocessing may
shall follow their facility policies and procedures and
laryngoscope blade
degrade
potentially
to follow these instructions may cause damage
REF:
laryngoscope blade assemblies may be
assemblies mu s t be reprocessed
elements of the device.
a patient’s airway
6924X, and Miller REF:
with
medical device
instructions
intubation.
patients
equipment
product warranty.
contaminated
equipment.
magnetic
for their
Follow
wear
and
aid
after
inspection
with
can lead to
appropriate
fields.
CAUTION:
CAUTION:
disinfectants.
CAUTION:
CAUTION:
CAUTION:
Only use neutral pH
Only use neutral pH
Do not use other cleaners or
Do not remove lamp during reprocessing. Damage to device could occur.
REF 68470 is not compatible with any sterilization process.
(6.0-8.0)
(6.0-8.0)
enzymatic type cleaners.
ortho-phthalahyde
disinfectants.
(OPA)
or glutaraldehyde
2
Directions for use
Welch Allyn standard laryngoscope
blade assemblie
Reprocessing
instructions
Reprocessing refers to procedures for cleaning and disinfection or sterilization of devices.
The standard 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
CAUTION:
Point of use: 1.
Preparation
decontamination:
Figure 1
the
following methods outlined in this
and cold solution high level
disinfection
document:
and gravity autoclave sterilization
and pre-vacuum autoclave sterilization
and Steris® Amsco® V-PRO® low temperature sterilization
and
STERRAD® hydrogen peroxide gas plasma sterilization
Do not remove lamp during reprocessing. Damage to device could occur.
Separate
assembly into suitable containment for
blade assembly from handle and place the blade
subsequent
reprocessing. See Figure 1. Do not place the blade
assembly with sharp devices.
2. Prevent the blade assembly from drying per
facility
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
moist
2. Keep all blade components together to prevent loss.
3. Select a neutral pH enzymatic cleaner.
4.
Prepare
manufacturer
cleaning solution per cleaning
instructions.
solution
Figure 2