Page 1
©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
Page 2
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
Page 3
Directions for use
Manual cleaning
process:
Drying:
Maintenance,
Inspection and Testing
prior to disinfection or
sterilization:
After cleaning,
Figure 3
1. Laryngoscope
2. Fiber
3. Locking
blade
optic light carrier
screw
Welch Allyn fiberoptic laryngoscope
1. Immerse all components in a neutral pH enzymatic
cleaning solution as directed by
manufacturer’s
instructions.
2. While components are immersed in the cleaning
use a soft-bristled brush to clean all component surfaces
(the blade, retaining screw, and fiber optic light carrier)
until all visible contamination is
3. Thoroughly rinse all components in one of the
potable filtered water, softened water, or per cleaning
solution manufacturer instructions, or per
instructions to remove cleaning
After cleaning, dry all components with a clean cloth or
to air dry.
1. Inspect
each
component
area (per
deterioration. Also, inspect the following
deterioration:
•
hooks of laryngoscope blade
carrier (2)
•
light fiber of light carrier (2)
•
threads of blade
(1)
and screw (3)
WARNING: Discard any component that
evidence of damage or deterioration.
Contact Welch Allyn for component replacement.
2. Reassemble the blade assembly by reversing
illustrated in Figure 2.
3. Attach blade assembly to a clean and disinfected
handle in known working condition. Ensure
•
Blade assembly engages and locks onto handle.
•
Blade assembly deploys into its locked position on
handle AND the handle’s lamp
•
Verify that light output is satisfactory.
If the la mp fails to
light or output is low
replace the fibe r o p t i c l i g h t c a r r i e r
choose
either cold solution high level disinfection method (page 4)
or
one of four sterilization methods (page 4-5).
solution
removed.
solution.
Figure
(1)
and fiber optic
illuminates.
blade assemblies
solution,
following:
facility
3)
for
damage
areas
for
shows
steps
test
that:
, check or
.
3
allow
or
light
Page 4
4
Directions for use
Cold solution high level disinfection instructions
Preparation
decontamination:
Cold solution high level
disinfection:
for
1. Select a neutral pH ortho-phthalahyde
glutaraldehyde
2.
Prepare
manufacturer
disinfecting solutions per disinfectant
1. Disassemble the blade per Figure 2.
2. Immerse all components in disinfectant solution for the
time duration specified by the disinfectant manufacturer
to achieve high level
3. Thoroughly rinse all components in one of the
potable water, softened water, deionized water, or high
purity water (for example, RO or distilled water) or per
disinfectant solution manufacturer instructions, or per
facility
solution.
instructions to thoroughly remove disinfection
Drying: After cleaning, dry all components with a clean cloth or
to air dry.
Assembly: Reassemble the
Packaging:
Storage: Store
End of
reprocessing
in Figure 2.
Package
the clean and disinfected blade assembly per
practice for return to service.
packaged
device to remain clean, dry, and ready for service.
instructions for cold solution high level disinfection.
Sterilization instructions
After maintenance, inspection and testing, select one
Gravity autoclave
Packaging: Package
wrap labeled as appropriate for the steam autoclave exposure parameters
below;
Gravity
package
autoclave
the set-up and operation of autoclave equipment. Gravity autoclave settings are as
follows:
•
Temperature: 132 C (270 F)
•
Exposure time: 15
•
Minimum dry time: 30
Storage: Store per facility practice to allow the
clean, dry and ready for service.
packaging, sterilization, and storage methods:
sterilization
the blade assembly in an appropriately sized single pouch or in a
the blade assembly per facility practice in preparation for autoclave.
sterilization: Follow equipment manufacturer
minutes (wrapped)
minutes
Welch Allyn fiberoptic laryngoscope
(OPA)
disinfectant.
blade assemblies
or
solution
instructions.
disinfection.
following:
blade
assembly by reversing steps
illustrated
blade assembly per facility practice to
of the following four
outlined
and
facility procedures in
packaged
blade assembly to remain
allow
facility
allow
Page 5
Directions for use
Pre-vacuum autoclave
Packaging: Package
wrap labeled as
below;
package
Pre-vacuum
appropriate
the blade assembly per facility practice in preparation for autoclave.
autoclave sterilization: Follow equipment manufacturer and
sterilization
the blade assembly in an appropriately sized single pouch or in a
for the
pre-vacuum autoclave
procedures in the set-up and operation of autoclave equipment.
settings are as
•
Temperature: 132 C (270 F)
•
Exposure time: 4
•
Minimum dry time: 20
follows:
minutes (wrapped)
minutes
Storage: Store per facility practice to allow the
Welch Allyn fiberoptic laryngoscope
exposure parameters
packaged
blade assembly to remain
blade assemblies
facility
Pre-vacuum
outlined
autoclave
clean, dry and ready for service.
Steris® Amsco® V-PRO® low temperature
Packaging: Package
the blade assembly per facility practice in an appropriately sized
single pouch or in a wrap labeled as appropriate for the Steris
sterilization
®
Amsco® V-PRO
collection of low temperature sterilization eq uipment and exposure parameters.
Steris® Amsco® V-PRO® low temperature sterilization: Follow equipment manufacturer
and facility procedures in the set-up and operation of Steris
temperature sterilization equipment.
• V-PRO
• V-PRO 1 PLUS:
• V-PRO
1: Lumen cycle
Lumen cycle, non-Lumen cycle
maX: Lumen cycle, non-Lumen cycle, Flexible cycle
Storage: Store per facility practice to allow the
V-PRO® sterilization settings are as
packaged
®
Amsco® V-PRO® low
follows:
blade assembly to remain
clean, dry and ready for service.
STERRAD® hydrogen peroxide gas plasma
Packaging: Package
the blade assembly per facility practice in an appropriately sized
single pouch, tray or in a container labeled as appropriate for the
sterilization
STERRAD® hydrogen
peroxide gas plasma exposure parameters.
STERRAD® hydrogen peroxide gas plasma sterilization: Follow equipment manufacturer
and facility procedures in the set-up and operation of the
gas plasma sterilization equipment.
sterilization systems and cycles
• STERRAD
• STERRAD
• STERRAD
• STERRAD
100S:
100S: Long cycle (outside of US only)
NX:
100NX: Express,
are as
Standard
Standard,
Advanced cycles
Storage: Store per facility practice to allow the
STERRAD® hydrogen peroxide gas plasma
follows:
(short) cycle
Standard
cycles
packaged
STERRAD® hydrogen peroxide
blade assembly to remain
clean, dry and ready for service.
End of
reprocessing
instructions for sterilization.
5
®
Page 6
6
Directions for use
Welch Allyn fiberoptic laryngoscope
blade assemblies
Maintenance
Replace
the fiber optic light carrier
To replace the fiber optic light carrier:
1. Remove the locking screw by rotating counterclockwise with a standard
2. Pull light carrier away from base of laryngoscope and slide distal end of carrier out
3. Position new carrier and replace locking
4. Rotate locking screw clockwise until secure.
5. Verify lamp and blade engagement/operation using a known working test handle.
6. Reprocess repaired assembly as appropriate per these instructions.
Specifications
Electrical:
For use with ISO 7376-3 (green code) handles only
For information about electromagnetic compatibility (EMC) see Welch Allyn website:
http://www.welchallyn.com
Operating:
32
(0 C)
Approvals:
Conforms to ASTM F 1195 and
instructions
(REF:
blade. See Figure 2.
Figure 2
Storage/Transport:
104 F
(40 C)
F
The
CE
mark on this product indicates that it has been tested to and
with the provisions noted within the
Complies with EMC Framework of Australia
-4 F
(-20 C)
6906X, 6921X, and 6806X)
120 F
(49 C)
ISO-7376-3, IEC/EN
screw.
93/42/EEC
60601-1,
Medical Device
IEC/EN
60601-1-2
conforms
Directive.
screwdriver.
of
Warranty:
One year
Service Information:
For
Technical
Welch Allyn
Support or to obtain information about any Welch Allyn product,
Technical
Welch Allyn, Inc.
4341 State Street Road
Skaneateles Falls, NY 13153-0220 USA
www.welchallyn.com
Support: w
ww.welchallyn.com/support.
Authorized European Re presentative Add ress:
Regulatory Affairs Representative
Welch Allyn, Limited
Navan Business Park
Dublin Road
Navan, County Meath, Republic
contact
of Ireland
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