American Diagnostic Corporation (ADC) Satin Standard User Manual

ADC®SatinTMStandard,

Fiber Optic and Disposable

Laryngoscope Blades and Handles

Directions
for Use

Thank you for choosing an ADC® Satin™ Laryngoscope.

Device Description and Intended Use

A Laryngoscope is a two-part, hand held device consisting of a handle that contains batteries and a de­tachable blade. Laryngoscopes are designed to provide illumination within the larynx during the process
of performing intubations. This instruction book covers both standard, fiberoptic type and disposable
laryngoscopes. Fiberoptic Laryngoscopes are indicated by an F following the item number / Disposables
are indicated by a D following the item number.

Contraindications

The following are only relative contraindication to tracheal intubation:

1. Severe airway trauma or obstruction that does not permit safe passage of an endotracheal tube.
Emergency cricothyrotomy is indicated in such cases.

2. Cervical spine injury, in which the need for complete immobilization of the cervical spine makes en­dotracheal intubation difficult.

General Warnings

A warning statement in this manual identifies a condition or practice which, if not cor­rected or discontinued immediately could lead to patient injury, illness, or death.

WARNING: Federal law restricts this device to sale by or on the order of a physician or licensed healthcare
practitioner.

WARNING: ONLY TRAINED PERSONNEL SHOULD USE A LARYNGOSCOPE FOR INTUBATION
WARNING: ADC

®

recommends that spare lamps, batteries, and replacement parts always be available for emer­gency use.
WARNING: The sterilization guidelines included in this instruction booklet, provided by American Di­agnostic Corp. (ADC
must be performed to approved hospital protocol. ADC

®

), are intended as procedures compatible with specific materials. Sterilization

®

cannot guarantee that any of the recommended
methods will guarantee sterility. This must be validated by the hospital and/or sterilization equipment
manufacturer.
WARNING: Fiberoptic handles may be used with ALL fiberoptic blades (reusable or disposable) that
conform to the ISO 7376-1 and ISO 7376-3 standards. Standard handles may be used with any standard
blades that conform to the ISO 7376-1 and ISO 7376-2 standards. Standard and fiberoptic blades and handles
are NOT interchangeable.

Operation of all Laryngoscope Models

To Activate:Attach selected blade onto handle by hooking blade onto

handle rod as shown in Figure 1. Pull blade upward to open position to
automatically activate light. To turn off, push blade downward into off
position and disconnect from handle. (See Figure 1).

Compatibility/Standards

Figure 1

Standard ADC®Satin™ Laryngoscopes conform to current ASTM F965, ISO 7376-1, and ISO 7376-

2 standards. They are compatible with virtually all major brands of standard illumination hook on blades
and handles.

Fiber optic ADC

®

Satin™ Laryngoscopes and Disposable Laryngoscope blades conform to current
ASTM F1195, ISO 7376-1, and ISO 7376-3 standards. They are compatible with virtually all major
brands of fiber optic illumination hook on blades and handles. For easy visual identification, ALL Fiber
Optic models are clearly delineated by a green indicator on both handle and blade.

Cleaning, Disinfecting, and Sterilization Procedures

ADC®Satin™ Laryngoscope blades are crafted from rugged stainless steel. ADC®Disposable Fiberoptic
Laryngoscope blades are crafted from poly-carbonate, and are for single use only and should not be
cleaned or sterilized. Reusable handles are machined from chrome-plated brass or anodized aluminum.
To ensure maximum life and optimum performance, the following instructions should be strictly adhered
to. Disposable handles are made of ABS, and are for single use only and should not be cleaned or ster­ilized.

Cleaning Procedure (all reusable models):Almost immediately after use, Laryngoscope Blades
should be cleaned to prevent blood, saliva etc. residues from drying. On Conventional blades, the lamp
socket and wires are an integral part of the blade for cleaning and replacement.

WARNING: Ultrasonic cleaning is not recommended.

Disinfection/Sterilization Warnings for All Laryngoscope Blades
CAUTION:ADC

®

laryngoscope blades do not come sterilized. The Sterrad process is NOT to be used
with disposable fiberoptic blades or fiberoptic blades.
WARNING: Flash autoclaving and hot air sterilization are not recommended, these processes will dam­age the instrument. The repeated high temperature and changes in temperature caused by autoclaving
will shorten the life of all laryngoscope products.
WARNING: Do not immerse blades in Bleach, Betadine, or peroxide solutions. Doing so will severely
damage the instrument. Also, avoid metal to metal contact on non-disposable blades.

Disinfection/Sterilization Warnings for All Battery Handles:
CAUTION:Do not allow excess fluid to seep into electrical contact. Be sure that the top and bottom of

the battery handle are secure before use. Poor maintenance of this device or failure to follow the warnings
in this instruction booklet could result in device failure and/or patient injury.

Repair/Maintenance

Battery Replacement: (Reuseable Models)

1) Unscrew bottom portion of handle and remove batteries.

2) Alkaline batteries should be used with your handle for maximum performance
and are recommended for replacement. Ordinary carbon zinc batteries may also
be used.

3) Replace with appropriate size battery, taking care to insert positive end first. On
stubby handle, insert one battery with negative end against screw and insert second
battery with positive end in first (See Figure 2).

Lamp Replacement: (Standard Models)

For correct illumination, alignment, and assurance of watertight seal during immer-

Figure 2

sion/autoclave, we recommend using only ADC #4500-1 and #4501-1 replacement lamps for standard
blades.

1) To remove lamp on standard blades, grip lamp collar and rotate lamp counterclockwise until free.

2) Replace the lamp with a new ADC lamp.

3) Verify that lamp is sufficiently tightened before use.

CAUTION: Be sure lamp’s glass surface is clean and free from fingerprints after assembly. If necessary,
the glass may be cleaned with a soft cloth or cotton ball moistened in alcohol.

Lamp Replacement: (Fiberoptic Models) For correct illumination and alignment we recommend
using only ADC replacement lamp model #4532-1 (See Figure 3).

1) Prior to removal, allow lamp time to cool.

2) Unscrew the laryngoscope head from the barrel of the handle in a coun-
terclockwise direction. Cartridge (lamp holder) will remain in head (top por-
tion of handle).

3) Unscrew the cartridge from the head in a counterclockwise direction.

4) Unscrew the plastic shroud from the cartridge in a counterclockwise direction.

5) Unscrew the lamp in a counterclockwise direction.

6) Replace the ADC

®

lamp and tighten it sufficiently.

7) Replace the plastic shroud and screw the cartridge back onto the head.

Lam p
Hol der
Car tri dge
Ass emb ly

Figure 3

8) Screw the head back on the barrel of the handle.

CAUTION: Be sure lamp’s glass surface is clean and free from fingerprints after assembly. If necessary,
the glass may be cleaned with a soft cloth or cotton ball moistened in alcohol.

Fiber Optic Light Guide Replacement

1) Loosen the locking screw with a screwdriver. (Note: This screw is
NOT designed to be completely removed.
This prevents the screw from falling out while the laryngoscope is in
use. DO NOT attempt to remove this screw from the laryngoscope
blade.)

2) Pull out the green base of the fiberoptic bundle and slide out the
light guide (See Figure 4). (Note: The fiberoptic bundle is tightly fitted

Figure 4

and may be difficult to remove.)

3) Insert new fiberoptic bundle by reversing the above steps.

4) Tighten the locking screw, ensuring that the fiberoptic bundle is securely attached to the laryngoscope
blade.

Test Procedures

Laryngoscope blades and handles should always be tested after cleaning/disinfecting/sterilization, and
prior to use. To test, connect the laryngoscope blade to handle and push blade to ON position. If the unit
fails to light or flickers, check the lamp for a secure connection, batteries, and electrical contacts. Be sure
to have adequate supplies of replacement bulbs and batteries.

Caps on battery handle should be secure before use. If they are not, it could cause the blade
to move out of position. Laryngoscopes should be visually inspected for wear or aging prior to
use and after long storage periods. It is strongly recommended that back-up laryngoscopes are

kept on hand for emergency situations.

Basic Cleaning Procedure for Standard and Fiberoptic Blades

Prepare a Klenzyme®, Manu-klenz™, or equivalent cleaning solution as per manufacturer’s

instructions and soak for ten minutes. Rinse devices with lukewarm running tap water for

one minute to remove any residual detergent after cleaning. Dry with a clean, lint-free cloth.

Note: Always allow blades to completely dry before disinfection or use.

Basic Cleaning Procedures for Standard and Fiberoptic Handles

Prepare a Klenzyme®, Manu-klenz™, or equivalent cleaning solution as per manufacturer’s in-

structions. Remove both end caps from device and rinse with lukewarm tap water until all visible

contamination has been removed. Soak handle and end caps in the prepared solution for a mini-

mum of ten minutes, ensuring that all components are fully submerged. After the soak, the compo-

nents should be scrubbed with a soft bristled brush paying particular attention to hard to reach

areas. Rinse with cool running tap water to remove all residual detergent. Dry with a clean, lint free

cloth. Note: Always allow handles to completely dry before disinfection or use.

High Level Disinfection for Standard and Fiberoptic Blades

To achieve high level disinfection, a 2.4% glutaraldehyde solution (Cidex® or equivalent) must be

prepared at 77°F (25°C) to the manufacturer’s instructions. The blades should be fully immersed

in the disinfectant for a minimum of 45 minutes. No air bubbles should be visible on the immersed

blades during this soak time. The blades should then be removed from the disinfectant and im-

mersed in purified water to rinse off all disinfectant. Immersion should be for a minimum of one

minute and the process should be repeated two additional times using fresh purified water each

time. Once rinsing is complete, the blades should be thoroughly dried using a sterile, lint-free

cloth. Note: Always allow blades to completely dry before use.

High Level Disinfection for Disposable Fiberoptic Blades

Disposable fiberoptic laryngoscope blades are supplied non-sterile. They are designed for

single patient use only and are not disinfected after use. Gas sterilization by Ethylene oxide

following these guidelines. Temperature 55°C (±5°C) EO pressure - 180 mmHg (± 20

mmHg) Chamber pressure 210mmHg (±20mmHg).

High Level Disinfection for Standard and Fiberoptic Handles

To achieve high level disinfection, a 2.4% glutaraldehyde solution (Cidex® or equivalent) must be

prepared at 77°F (25°C) to the manufacturer’s instructions. The end caps of the handles must be

removed and both the end caps and handles should be fully immersed in the disinfectant for a

minimum of 45 minutes. No air bubbles should be visible on the immersed components during

this soak time. The components should then be removed from the disinfectant and immersed in

purified water to rinse off all disinfectant. Immersion should be for a minimum of one minute and

the process should be repeated two additional times using fresh purified water each time. Once

rinsing is complete, the components should be thoroughly dried using a sterile, lint-free cloth.

Note: Always allow components to completely dry before reassembling the handles, inserting bat-

teries, or using the devices.

Steam Sterilization for Standard and Fiberoptic Blades and Handles

Sterilizer Type: Prevacuum Sterilizer Type: Gravity
Preconditioning Pulses: 3 Minimum Temperature: 249.8°F
Minimum Temperature: 269.6°F (132°C) (121°C)
Full Cycle Time: 4 minutes Full Cycle Time: 30 minutes
Minimum Dry Time: 20 minutes Minimum Dry Time: 15 minutes

LIMITED WARRANTY

American Diagnostic Corporation (ADC®) warrants its products against defects in materials
and workmanship under normal use and service as follows:

1. Warranty service extends to the original retail purchaser only and commences with the
date of delivery.

2. Your Laryngoscope is warranted for one year from date of purchase (all parts).

What is Covered: Replacement of parts, and labor.
What is Not Covered: Transportation charges to and from ADC

®

. Damages caused by
abuse, misuse, accident, or negligence. Incidental, special, or consequential damages.
Some states do not allow the exclusion or limitation of incidental, special, or consequential
damages, so this limitation may not apply to you.
To Obtain Warranty Service: Send item(s) postage paid to ADC

®

, Attn: Repair Dept., 55 Com­merce Dr., Hauppauge, NY 11788. Please include your name and address, phone no., proof of pur­chase, and a brief note explaining the problem.
Implied Warranty: Any implied warranty shall be limited in duration to the terms of this warranty
and in no case beyond the original selling price (except where prohibited by law).
This warranty gives you specific legal rights and you may have other rights which vary from
state to state.

REPLACEMENT PARTS CHART

DESCRIPTIONS

Laryngoscope Standard Standard Fiberoptic Fiberoptic Fiberoptic SPU

Item Blade Replacement Lamp Blade Replacement Lamp Light Guide Blade

Mac 0 4070 4500 4070F N/A 4070FLP-00 N/A
Mac 1 4071 4500 4071F N/A 4071FLP-00 4071D-20
Mac 2 4072 4500 4072F N/A 4072FLP-00 4072D-20
Mac 3 4073 4501 4073F N/A 4073FLP-00 4073D-20
Mac 4 4074 4501 4074F N/A 4074FLP-00 4074D-20
Miller 00 4080-0 4500 N/A N/A N/A 4080-0D-20
Miller 0 4080 4500 4080F N/A 4080FLP-00 4080D-20
Miller 1 4081 4500 4081F N/A 4081FLP-00 4081D-20
Miller 2 4082 4501 4082F N/A 4082FLP-00 4082D-20
Miller 3 4083 4501 4083F N/A 4083FLP-00 4083D-20
Miller 4 4084 4501 4084F N/A 4084FLP-00 4084D-20
Wisconsin 0 4090 4500 N/A N/A N/A N/A
Wisconsin 1 4091 4500 N/A N/A N/A N/A

Wisconsin 1.5 40915 4500 N/A N/A N/A N/A
Wisconsin 2 4092 4501 N/A N/A N/A N/A
Wisconsin 3 4093 4501 N/A N/A N/A N/A
Wisconsin 4 4094 4501 N/A N/A N/A N/A

“C” Cell Handle 4065 N/A 4065F 4532 N/A 4065D-20

“AA” Cell Handle 4066 N/A 4066F 4532 N/A N/A

Stubby Handle 4067 N/A 4067F 4532 N/A N/A

STANDARD MODELS

FIBEROPTIC MODELS

SPU MODELS

ADC
55 Commerce Drive
Hauppauge, NY 11788
U.S.A.

ADC (UK) Ltd.
Unit 6, PO14 1TH
United Kingdom

IB p/n 9358-00 rev 10 english

Inspected in the U.S.A.

tel: [phone]

Made in China

fax: [phone]

www.adctoday.com

email: [e-mail]