American Diagnostic Corporation Satin Manual

ADC®SatinTM Standard,
Fiber Optic and Disposable
Lar ngoscope Blades and Handles
Directions
for Use
®

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Thank you for choosing an
ADC®Satin™ aryngoscope.
Device Description and Intended Use
A laryngoscope is a two-part, hand-held device consisting of a handle that contains bat-
teries and a detachable blade. aryngoscopes are designed to provide illumination
within the larynx during the process of performing intubations. This instruction book cov-
ers standard, fiberoptic, and disposable laryngoscopes. Fiberoptic laryngoscopes are in-
dicated by an “F” following the item number.
Disposables are indicated by a “D” following the item number.
Contr indic tions
The following are only relative contraindication to tracheal intubation:
1. Severe airway trauma or obstruction that does not permit safe passage of an endotra-
cheal 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 w rning st tement in this m nu l identifies condition or pr ctice
which, if not corrected or discontinued immedi tely, could le d to p tient
injury, illness, or de th.
WARNING: Federal law restricts this device to sale by or on the order of a physician or li-
censed healthcare practitioner.
WARNING: ON Y TRAINED PERSONNE SHOU D USE A ARYNGOSCOPE FOR
INTUBATION.
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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 are intended as
procedures compatible with specific materials. Sterilization must be performed to approved
hospital protocol. ADC®cannot guarantee that any of the recommended methods will guar-
antee sterility. This must be validated by the hospital and/or sterilization equipment manu-
facturer.
WARNING: Fiberoptic handles may be used with A fiberoptic blades (reusable or dis-
posable) that conform to the ISO 7376 standards. Standard handles may be used with any
standard blades that conform to the ISO 7376 standards. Standard and fiberoptic blades and
handles are NOT interchangeable.
peration of all Laryngoscope Models
To Activ te: Attach selected blade onto handle by hooking
blade onto handle rod as shown in Figure 1. Pull blade up-
ward to open position to automatically activate light.
To turn off, push blade downward into off position and dis-
connect from handle. (See Figure 1).
Compatibility/Standards
Standard ADC®Satin™aryngoscopes conform to current ISO 7376 standards. They are
compatible with virtually all major brands of standard illumination hook-on blades and
handles.
Fiberoptic ADC®Satin™aryngoscopes and Disposable aryngoscope blades conform
to current ISO 7376 standards. They are compatible with virtually all major brands of
fiberoptic illumination hook-on blades and handles. For easy visual identification, A
fiberoptic models are clearly delineated by a green indicator on both handle and blade.
Off Position
Handle Rod
Pull Blade Up
Into On
Position
OnPosition
Figure 1
Off Position
Handle Rod
Pull Blade Up Into
On Position
On Position

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Cleaning, Disinfecting, and Sterilization Procedures
ADC®Satin™ aryngoscope blades are crafted from rugged stainless steel. ADC®Dispos-
able Fiberoptic aryngoscope 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.
See the sections on the reverse panel for specific cleaning, disinfection, and
sterilization procedures for your laryngoscope type.
Cle ning Procedure for All Reus ble Models: Almost immediately after use,
laryngoscope blades should be cleaned to prevent blood, saliva, etc. residues from dry-
ing. 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/Steriliz tion W rnings for All L ryngoscope Bl des
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, as 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-dis-
posable blades.
Disinfection/Steriliz tion W rnings for All B ttery H ndles:
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. NOTE: Remove lamp cartridge, bulb, and batteries before disinfecting/steril-
izing.

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B sic Cle ning Procedure for St nd rd nd Fiberoptic Bl des:
Prepare a Klenzyme®, Manu-klenz™, or equivalent cleaning solution as per manufac-
turer’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.
B sic Cle ning Procedures for St nd rd nd Fiberoptic H ndles:
Prepare a Klenzyme®, Manu-klenz™, or equivalent cleaning solution as per manufacturer’s in-
structions. Remove both end caps, lamp cartridge and bulb, and batteries 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 minimum of ten minutes, ensuring that all compo-
nents are fully submerged. After the soak, the components 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. amp cartridge and bulb can be wiped
with a cloth dampened with 70% isopropyl alcohol. DO NOT A OW SO UTION TO ENTER
INTO THE CARTRIDGE. The lamp cartridge and bulb CANNOT be SOAKED OR AUTO-
C AVED.
High-Level Disinfection for St nd rd nd Fiberoptic Bl des:
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 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 blades should be
thoroughly dried using a sterile, lint-free cloth. Note: Always allow blades to completely dry
before use.
High-Level Disinfection for Dispos ble Fiberoptic Bl des:
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).