Laryngoscopes by Astralite Corp.

Service

Operating Instructions
For the LFRE (Laropharyngeal Fiberoptic Rigid Endoscope)
Revision 022703

GENERAL
This endoscope (periscope) is a precision diagnostic device for the safe examination, diagnosis and evaluation of physiological and pathological states of the larynx and pharynx. Convenient viewing is permitted of the:
1. Larynx, including the epiglottic folds, the true and false vocal cords, the anterior
commissure, aryepiglottic folds, arytenoids cartilage, and the pyriform fossae.
2. Velopharynx, including movements of posterior and lateral walls of the pharynx and posterior soft palate.
3. The fossae of Rosenmuller, revealing the torus and mouth of the Eustachian tube, the posterior nasal septum and Waldeyer’s Ring.

SAFETY
The endoscope design eliminates the hazard of heat in the posterior pharynx by utilizing a glass fiber bundle that projects ‘cold’ light through the distal end of the periscope and onto the desired field of view. Also, the danger of electrical current being transmitted to the patient is eliminated.

PATIENT COMFORT
Most patients with a minimal gag reflex can be examined without anesthesia. Topical Cetacaine or Americaine aerosol can be used on those patients with high gag reflexes.

CLEANING PROCEDURE
A. The proximal eyepiece and the objective lens should be cleaned routinely before and after each use with lens tissue or a swab dipped in alcohol.

B. The periscope can be sterilized with cold solutions.
a. DO NOT immerse more than 5” of the distal end of the scope.
b. Prolonged soaking should be avoided.
c. DO NOT boil or steam autoclave.
d. DO NOT use corrosive or petroleum distillate-solvent solutions.
e. DO NOT immerse eyepiece.
f. DO FOLLOW THE DETAILED INSTRUCTIONS below.

As stated in paragraph 4.1 of the ASTM F 1518 Standard Practice, “Because endoscopes are used to diagnose disease in immunocompetent and immunocompromised individuals, care must be taken to ensure that only endoscopes that are patient-ready are used for each examination.”. Although the content of this referenced ASTM article goes well beyond that necessary to render the Astralite LarynxScope suitable for reuse, reprocessing personnel should have read and should understand the underlying philosophy governing cleaning and sterilization of this type of equipment.

1. Reprocessing personnel should be suitably clothed and trained for reprocessing the LarynxScope.
2. The following supplies should be on hand so that reprocessing can take place with minimal effort and maximum efficiency:
2.1 A source of clean rinse water (treated city tap water is ok).
2.2 Detergent – Astralite recommends Advanced Sterilization Products’ ENZOL Enzymatic Detergent.
2.3 High-Level Disinfectant – Astralite recommends Advanced Sterilization Products’
Cidex OPA, or Cidex Activated Dialdehyde Solution. In those healthcare facilities where exposure to glutaraldehyde solutions may be a problem, the Cidex orthophthalaldehyde (“OPA”) solution is an effective alternative .
2.4 Suitable plastic containers for soaking the distal end of the LarynxScope. Astralite has determined that a common 20-oz drinking water container with screw cap is appropriate because the scope can be inserted into the bottle, distal end first, and can not be totally immersed since the right-angle fiberoptic attachment is too big to permit the scope to go through the neck opening.
2.5 Single-use towels for drying the LarynxScope. Astralite recommends Kimberly-Clark “Kimwipes” for the purpose, as they are absorbent and will not scratch optical surfaces.
2.6 Single-use soft-bristle brushes.
3. As soon as practical after use, rinse the distal end of the LarynxScope off in tepid tap water. There should be little or no visible organic debris on the optics tube. Place the scope into a container filled with ENZOL and allow it to soak approximately 5-minutes. If there is debris on the scope, use a soft-bristle brush to clean it. Remove, and rinse off excess solution in running tap water. There should be no visible organic debris; if there is, repeat this operation . Wipe the scope and allow it to dry in open air.
4. For high-level disinfection, prepare a solution of CIDEX according to the manufacturer’s instructions, and fill a container (2.4). Immerse the distal end of the LarynxScope and allow it to soak for 45-minutes. Wipe down the remainder of the scope with a gauze dipped in CIDEX solution (total immersion of the entire scope is not recommended, as there is a small risk of leakage through the eyepiece and fiberoptic junctions).
5. Rinse the scope in tepid tap water, wipe, and allow it to air-dry.
6. Follow the rinse with an alcohol-wipe to reduce the possibility of device contamination with water-borne micro-organisms. Protect the disinfected scope from contamination by suitably covering and storing it in a secure location.

OPERATION
1. Model LFRE-6. Fiberoptic periscope with Welch Allyn Adapter.
a. (Note that the W-A Adapter can be removed if the scope is to be used with any of the other available accessories.)
b. Attach any 3.8v W-A power handle to the scope (Adapter) by locking them together with a _-turn twist. First make certain there is a bulb in the Adapter.
c. Operate the W-A handle according to the manufacturer’s instructions (Make certain the batteries are charged first, if batteries are used). The distal end of the scope should illuminate when the handle rheostat is turned on.

2. Model LFRE-7. Fiberoptic periscope with 3.8v a.c. transformer.
a. Plug the 3.8v a.c. transformer to any 115v 50/60Hz convenience outlet.
b. Connect the power cord handle from the transformer to the periscope by pushing it onto the shaft. There is moderate resistance to both attaching and detaching the cord at the scope because a spring inside the handle ‘detents’ onto the shaft to keep the handle from slipping off during use. It is normal for the scope to rotate freely on the end of the handle.
c. When the in-line switch is turned ’on’, you should observe light from the distal end of the periscope. If not, make sure the bulb is screwed into the handle socket securely. See enclosed bulb replacement instructions before replacing it.

3. Model LFRE-8. Fiberoptic periscope with 6ft. cable and adjustable plug-in power supply.
a. Plug the adjustable power supply (cylindrical controller with adjustable rheostat at one end and grounded North American plug at other) into a grounded 115v convenience outlet. Turn the adjusting knob as low as possible.
b. Attach the pin connectors from the cable to the mating posts on the controller. Connect the power cord handle to the periscope connector. Comments of PROCEDURE paragraph 1-b apply here as well.
c. Turn the in-line switch ‘on’ to power the bulb. You should observe light from the end of the periscope as the controller knob is adjusted higher. If not, make sure the bulb is screwed into the handle socket securely. See enclosed bulb replacement instructions before replacing it.
4. When necessary, anesthetize the patient’s throat with Americaine or Cetacaine by spraying the uvula, glossopalatine folds, and the base of the tongue.
5. Examination can be accomplished in one of two positions:
a. Sitting, with the patient facing the examiner.
b. Lying supine with patient’s head extended at the end of the examining table.
In either case, using a square gauze, (and assuming the examiner is right-handed) the tongue is grasped with the thumb and index finger of the left hand, then the tongue is extended while the instrument is introduced with the other hand into the posterior pharynx.
6. Cephiad positioning of the objective lens, the posterior pharynx, nasopharynx, and Waldeyer’s Ring can be visualized.
7. Rotation of the instrument up to 90 degrees from either direction permits the visualization of the fossae of Rosenmuller and the Eustachian tube on that side.
8. Cauded positioning of the objective lens facilitates visual examination of the epiglottis, larynx, vocal cords, anterior commissure, aryepiglottic folds, arytenoids cartilage and the cyriform fossae.

When tested according to protocol of ISO 10993-IO:1995 (Intracutaneous Injection) on live animal subjects, a sample test article of the epoxy used to cement the glass optics into position at the distal end of the telescope exhibited “negligible or slight irritant” effects.