Welch Allyn Standard laryngoscope blade assemblies User Manual

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Page 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

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

Page 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

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.

Prepare manufacturer

cleaning solution per cleaning

instructions.

solution

Figure 2

Page 3

Directions for use

Manual cleaning process:

1. Immerse all components in a neutral pH enzymatic cleaning solution as directed by manufacturer’s

2. While components are immersed in the cleaning

Welch Allyn st andard laryngoscope

solution

instructions.

blade assemblies

solution, use a soft-bristled brush to clean all component surfaces (the blade, retaining screw, and light carrier) until all

Drying:

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

removed.

solution.

following:

facility

to air dry.

Maintenance, Inspection and Testing prior to disinfection or sterilization:

1. Inspect

each

component

area (per deterioration. Also, inspect the following deterioration:

•

hooks of laryngoscope blade

Figure

(1)

and

for

damage

areas

for

light assembly

(2)

•

lamp (3)

•

threads of blade

WARNING: Discard any component that

(1)

and l oc k i n g screw (4)

shows

evidence of damage or deterioration.

Contact Welch Allyn for component replacement.

2. Reassemble the blade assembly by reversing

steps

illustrated in Figure 2.

3. Attach blade assembly to a clean and disinfected handle in known working condition. Verify

•

Blade assembly engages and locks onto handle.

•

Blade assembly deploys into its locked position on

handle AND lamp

•

Verify that light output is satisfactory.

If the la mp fails to replace the lamp

illuminates.

light or output is low

that:

test

, check or

After cleaning; choose either cold solution high level disinfection method (page 4) for any blade or one of the four sterilization methods (page 4-5) except REF 68470

Figure 3

allow

1. Laryngoscope

2. Light assembly

3. Lamp

4. Locking

blade

screw

Page 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

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

CAUTION:

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 blade assembly per facility practice in preparation for 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.

REF 68470 is not compatible with any sterilization process.

packaging, sterilization, and storage methods:

sterilization

the blade assembly in an appropriately sized single pouch or in a

sterilization: Follow equipment manufacturer

minutes (wrapped)

minutes

Welch Allyn standard laryngoscope

disinfectant.

(OPA)

blade assemblie

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 st andard 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 equipment 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

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.

Page 6

Directions for use

Welch Allyn standard laryngoscope

blade assemblie

Maintenance

instructions

Replace

the la m p a n d / o r light a s s em b l y

(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. Remove the locking screw by rotating counterclockwise with a standard

screwdriver.

2. Pull light assembly away from base of laryngoscope bl a d e and slide distal end out

3. To replace lamp: Rotate lamp counterclockwise until free and insert a new lamp and tighten.

4. Position new or re-lamped light assembly the reverse order of step 2.

5. Replace locking screw and rotate clockwise until secure.

6. Verify lamp and blade engagement/operation using a known working test handle.

7. Reprocess repaired assembly as appropriate per these instructions.

Figure 2

Specifications

Electrical: For use with ISO 7376-1 (black co de) s t andard type handles only

For information about electromagnetic compatibility (EMC) see Welch Allyn website: http://www.welchallyn.com

blade.

(0 C)

104 F (40 C)

Operating:

Storage/Transport:

-4 F (-20 C)

120 F (49 C)

Approvals: Conf or ms to A ST M F 965 and

The

mark on this product indicates that it has been tested to and

with the provisions noted within the Complies with EMC Framework of Australia

ISO-7376-1, IEC/EN

93/42/EEC

60601-1,

Medical Device

IEC/EN

60601-1-2

conforms

Directive.

Warranty:

Service Information:

For

Technical

Welch Allyn

One year

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