Rigid Laryngostroboscope , Models 9106 and 9708 Instructions for Use Rev D

© PENTAX of America, Inc. All rights reserved. The information in this publication may be changed at any time, without prior notice. While technical inaccuracies, typographical errors, and editorial omissions may occur, PENTAX of America, Inc. disclaims all direct, indirect or consequential damages that may result from such errors. PENTAX of America, Inc. will make every effort to correct the deficiencies in new editions and updates. Distributed by: PENTAX of America, Inc. 3 Paragon Drive Montvale, NJ 07645-1725 USA Tel: +1-201-571-2300 Toll Free: +1-800-431-5880 Fax: +1-201-391-4189 STERRAD® is a registered trademark of Advanced Sterilization Products. STERIS ® is a registered trademark of STERIS Corporation. All other trademarks are the property of their respective owners.

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Table of Contents 1

Introduction ... 5 1-1 Intended Use ...5 1-2 Warnings and Precautions ...6 1-3 Using this Manual...6

2

Specifications ... 7 2-1 Components...7 2-2 Appearance ...7 2-3 Specifications ...7 2-4 Environmental and Storage Conditions ...8 2-5 Prolonging the Life of the Rigid Laryngostroboscope ...8

3

Preparation and Use ... 9 3-1 Assembly ...9 3-2 Cleaning, High Level Disinfection, and Sterilization ...10 3-2-1 Cleaning ...10 3-2-2 High-Level Disinfection ...11 3-2-3 Sterilization ...12 3-3 Use ...13

4

Disposal ... 14

5

Warranty... 14

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Introduction

PENTAX Medical Rigid Laryngostroboscopes, Model 9106 (9106) and Model 9108 (9108), provide optimal viewing of the vocal folds with a maximum transmission of light. The fiberoptic light guide cable of the rigid Laryngostroboscope is permanently attached to the laryngostroboscope and runs continuously from the distal tip of the rigid Laryngostroboscope to the distal end of the cable. This design provides the user with bright, clear, and high-quality images. This instrument is intended to observe glottic action with the use of a stroboscopic light source.

1-1

Intended Use

PENTAX Medical Rigid Laryngostroboscope Models 9106 and 9108 are intended to observe glottic action with the use of a stroboscopic light source. The instruments are inserted perorally when indications consistent with the need for observation are observed. Never use these Laryngostroboscopes for any purpose other than that for which they have been designed.

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Warnings and Precautions Warning You should read and understand the instructions in this manual before you perform any procedures using the 9106 or 9108. Failure to do so may result in injury to the patient or damage to the instrument. Caution Failure to follow the enclosed maintenance instructions could render the 9106 or 9108 non-usable and void any effective warranty.

Warning and Caution messages appear throughout this manual in the following formats: Warning Warning messages describe potential conditions that could result in death or serious injury.

Caution Caution messages describe potential problems that might result in minor/moderate injury or property damage.

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Using this Manual

This manual uses the following conventions: Convention Note

Italics

Definition Important information about a subject or the use of the device. Failure to follow a note can result in configuration or installation issues. Reference to other sections in this manual or to other documents.

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Specifications

2-1

Components

The 9106 and 9108 include the following components:  Rigid Laryngostroboscope  PENTAX Medical Laryngeal Stroboscope Adaptor (Model 7175-4200)

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Appearance

Figure 1.

2-3

Rigid Laryngostroboscope

Specifications

9106 Specifications

9108 Specifications

Total Length

252 mm

Working Length

189 mm

Outer Diameter

9.5 mm

Actual Visual Field Angle

35 degree

Angled View

70 degree

Depth of Field

2 mm-40 mm

Integral Light Cable

Yes

Light Guide Length

1727 mm

Total Length

226 mm

Working Length

186 mm

Outer Diameter

6 mm

Actual Visual Field Angle

35 degree

Angled View

70 degree

Depth of Field

2 mm-40 mm

Integral Light Cable

Yes

Light Guide Length

1750 mm

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Environmental and Storage Conditions

The 9106 and 9108 require the following conditions: Operating Conditions:

 Temperature: 10ºC to 40ºC (50ºF to 104ºF)  Relative humidity: 20% to 80% (non-condensing)  Atmospheric pressure: 700mb to 1060mb (0.69atm to 1.05atm)

Storage/Transportation Conditions

 Temperature: –10ºC to 60ºC (14ºF to 140ºF)  Relative humidity: 20% to 80% (non-condensing)

 Atmosphere pressure: 700mb to 1060mb (0.69atm to 1.05atm)

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Prolonging the Life of the Rigid Laryngostroboscope

The 9106 and 9108 provide high-quality performance over many examinations. The following precautions are essential to guarantee their longevity:



Bend the fiberoptic cable as little as possible. Never kink the cable. Excessive bending of the light guide cable will result in the breakage of fiberoptic bundles. This condition will in turn diminish light transmission within the device.



If the quality of the images created by the rigid Laryngostroboscope significantly degrade as a consequence of broken fibers, the entire rigid Laryngostroboscope must be replaced. The light guide cable cannot be replaced.



Do not scratch the lenses of the rigid Laryngostroboscope.

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Preparation and Use

3-1

Assembly

The 9106 and 9108 Laryngostroboscopes are compatible with several light sources. To use without a camera: 1. Insert the cable into a light source and look through the eyepiece (an adaptor may be required). When using PENTAX Medical Laryngeal Stroboscope Model 9400, the adaptor provided with the rigid Laryngostroboscope (Part Number 7175-4200) should be used. 2. Use the brightness adjustment on the front panel of PENTAX Medical Laryngeal Stroboscope Model 9400 to control the amount of light delivered to the rigid Laryngostroboscope. To use with a C-mount camera and attachment lens (e.g., PENTAX Medical 3CCD HD Camera Model 9214HD and Lens Coupler Model 9118B):

Figure 2. 1. 2. 3.

Rigid Laryngostroboscope

Screw the attachment lens into the C-mount of the camera. Insert the rigid Laryngostroboscope eyecup into the lens coupler. Align the eyecup and adaptor, and lock them into place using the screw. Caution Loosen the screw of the lens coupler prior to removing it from the eyecup in order to avoid damage to the rigid Laryngostroboscope. Note To use the 9106 or 9108 with other light sources, adaptors may be required. Please contact your local representative for information.

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Cleaning, High Level Disinfection, and Sterilization Warning The 9106 and 9108 are provided in a non-sterilized condition. Do not use them until they have been cleaned, high-level disinfected or sterilized, as this could pose a risk of infection to the patient.

3-2-1 Cleaning Caution Meticulous and thorough cleaning of the device is required in order to achieve high-level disinfection or sterilization. Failure to properly clean the device will result in ineffective or incomplete high level disinfection or sterilization. Caution Do not immerse the rigid Laryngostroboscope longer than required in the high-level disinfectant solution. Excessive exposure of the laryngostroboscope to high-level disinfectant solution can result in damage to the device, including clouding of the lenses and loosening of adhesives. Note Avoid any harsh materials that can scratch or damage optical and outer surfaces of the device. Note Remove any detachable items or components prior to cleaning, high-level disinfection or sterilization. Note: Standard material and practices for cleaning these devices should be followed Note: Avoid any harsh materials that can scratch or damage optical and outer surfaces of the device.

After every use, this device should be thoroughly cleaned in order to completely remove all organic debris.

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2.

3. 4. 5.

Fully immerse the device in an enzymatic detergent (e.g. Prolystica 2x Concentrate or equivalent), prepared as recommended by the detergent manufacturer, for a minimum of two (2) minutes, then rinse continuously in lukewarm water for at least one (1) minute. After rinsing, place the device in a basin of enzymatic detergent prepared as recommended by the detergent manufacturer (e.g. Manu-Klenz, Prolystica 2x Concentrate or equivalent). Manually clean the device with a soft brush and cloth, concentrating especially on any crevices, seams, or other surface discontinuities. Rinse the device thoroughly with lukewarm running tap water for at least one (1) minute. Visually inspect the device for cleanliness. If any organic debris remains on the device after cleaning, repeat the cleaning process in its entirety until all visible debris has been completely removed.

3-2-2 High-Level Disinfection There are two options for high level disinfection:  Totally immerse the device in 2.4% Glutaraldehyde, prepared as recommended by the manufacturer, for the time period and at the temperature recommended by the disinfectant manufacturer. In the case of most 2.4% glutaraldehydes, the recommended immersion time to achieve high-level disinfection is 45 minutes, and the high-level disinfectant temperature is 25ºC.  Totally immerse the device in a CIDEX® OPA, prepared as recommended by the manufacturer, for 12 minutes at 20ºC.

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3-2-3 Sterilization Caution Do not steam sterilize these devices. Exposure to temperatures greater than 60˚C (140˚F) will damage the device and render it unusable. There are five options for sterilization:



Totally immerse the device in a 2.4% Glutaraldehyde solution for the time and at the temperature recommended by the manufacturer to achieve liquid chemical sterilization.



Sterilize via Ethylene Oxide (EtO) according to the following sterilization cycle parameters: o EtO concentration: 600  30 mg/L o Humidity: 70%  5% o Exposure: 240 minutes o Aeration: 12 hours at 55ºC  2ºC



This device is compatible with STERRAD® 100S when following the sterilizer manufacturer’s procedures and guidelines.



This device is compatible with STERIS ® SYSTEM 1E when following the sterilizer manufacturer’s procedures and guidelines.



This device is compatible with STERIS® V-PRO® when following the sterilizer manufacturer’s procedures and guidelines.

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Use Caution Thoroughly inspect the device before each use. Check the function of the device and visually inspect optics for moisture or contamination. Do not drop the device or subject it to sudden impact. Refer to section 5 Warranty for information regarding damage to the device. Caution Never insert the rigid Laryngostroboscope in any fluid at a temperature of 150º F (60º C) or greater.

Caution Hot beads can damage the rigid Laryngostroboscope and should not be used for anti-fogging.

Note The optimal working distance between the distal tip of the rigid laryngostroboscope and the object under direct visual observation is 5 to 50 mm. Note The angle of entry with these 70-degree rigid Laryngostroboscopes is markedly different from that of 90-degree rigid Laryngostroboscopes. While 90-degree devices point upward in the patient’s mouth, these 70-degree rigid Laryngostroboscopes angle downward to allow a closer view of the vocal fold. Warning Although complications resulting from use of a rigid Laryngostroboscope for viewing the larynx are extremely rare, the following potential complications can occur:  Laryngospasm  Blood pressure elevation during the procedure  Bleeding as a result of injury caused by improper endoscopic technique  Adverse reaction to an anaesthetic (if used to prevent gagging)

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To use the 9106 or 9108: Follow the cleaning and high level disinfection or sterilization procedures described in Section 3-2, Cleaning, High Level Disinfection, and Sterilization. To avoid lens fogging, dip the working end of the rigid Laryngostroboscope into a container of hot tap water for 10-20 seconds, and blot the working end with a soft tissue prior to insertion into patient’s mouth. (This procedure might need to be repeated during the patient procedure.)

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Disposal This product is a medical device. In accordance with European Directive 2002/96/EC on Waste Electrical and Electronic Equipment, this symbol indicates that the product must not be disposed of as unsorted waste, but should be collected separately. Contact your local PENTAX Medical distributor for correct disposal and recycling instructions. Proper disposal of this product will help ensure that the waste undergoes the necessary treatment, recovery, and recycling, thus preventing potential negative effects on the environment and human health that might otherwise arise due to inappropriate waste handling. Note: Follow local, state, and federal guidelines for the proper disposal of waste products.

5

Warranty

All devices are guaranteed against defective materials and workmanship for one (1) year. This is a sealed unit and all repairs must be made by factorytrained personnel only. Improperly treated, misused, mishandled or out-ofwarranty products will be repaired or replaced for a fee.

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