Verathon RIGID STYLET User guide

Page 1
GLIDERITE
RIGID STYLET
Operations & Maintenance Manual
Page 2
0900-4686 REV-02
Page 3
GLIDERITE
RIGID STYLET
Operations & Maintenance Manual
Effective: June 4, 2020
Caution: Federal (United States) law restricts this
device to sale by or on the order of a physician.
0900-4686 REV-02
Page 4
To obtain additional information regarding your GlideScope system or GlideRite Rigid Stylet,
please contact Verathon Customer Careor visit verathon.com/global-support.
Verathon Inc.
20001 North Creek Parkway
Bothell, WA 98011 U.S.A.
Tel: +1 800 331 2313 (US and Canada only)
Tel: +1 425 867 1348
Fax: +1 425 883 2896
verathon.com
Verathon Medical (Europe) B.V.
Willem Fenengastraat 13
1096 BL Amsterdam
The Netherlands
Tel: +31 (0) 20 210 30 91
Fax : +31 (0) 20 210 30 92
Verathon Medical (Canada) ULC
Verathon Medical (Australia) Pty Limited
Within Australia: 1800 613 603 Tel / 1800 657 970 Fax
International: +61 2 9431 2000 Tel / +61 2 9475 1201 Fax
Copyright © 2020 by Verathon Inc. All rights reserved.
2227 Douglas Road
Burnaby, BC V5C 5A9
Canada
Tel: +1 604 439 3009
Fax: +1 604 439 3039
Unit 9, 39 Herbert Street
St Leonards NSW 2065
Australia
GlideScope, the GlideScope symbol, GlideRite, Verathon, and the Verathon Torch symbol are trademarks of Verathon Inc. All other brand and product names are trademarks or registered trademarks of their respective owners.
Not all Verathon Inc. products shown or described in this manual are available for commercial sale in all countries.
Information in this manual may change at any time without notice. For the most up-to-date information, see the documentation available at verathon.com/product-documentation
0900-4686 REV-02
Page 5
TABLE OF CONTENTS
IMPORTANT INFORMATION ................................................................................................................................. 1
Product Description ............................................................................................................................................1
Statement of Intended Use ..................................................................................................................................1
Statement of Prescription ....................................................................................................................................1
Notice to All Users ..............................................................................................................................................1
Warnings ............................................................................................................................................................ 2
INTRODUCTION ....................................................................................................................................................4
USING THE STYLET ...............................................................................................................................................5
Procedure 1. Use the GlideRite Rigid Stylet .................................................................................................5
REPROCESSING ...................................................................................................................................................... 6
PRODUCT SPECIFICATIONS ................................................................................................................................... 7
Specifications ......................................................................................................................................................7
Dimensions .........................................................................................................................................................7
GLOSSARY .............................................................................................................................................................8
Operations & Maintenance Manual: Table of Contents
i
0900-4686 REV-02
Page 6
Page 7

IMPORTANT INFORMATION

PRODUCT DESCRIPTION

The GlideRite Rigid Stylet was designed to help enable the placement of an endotracheal tube (also known as an ETT or ET tube). The rigidity of this reusable stylet helps the user manipulate the tube as desired for intubation. The stylet is for use in 6.0mm and larger endotracheal tubes.

STATEMENT OF INTENDED USE

To provide support for an endotracheal tube during intubation.

STATEMENT OF PRESCRIPTION

Caution: Federal (United States) law restricts this device to sale by or on the order of a physician.

NOTICE TO ALL USERS

Verathon recommends that all users read this manual before using the GlideRite Rigid Stylet. Failure to do so may result in injury to the patient, may compromise the performance of the stylet, and may void the warranty. Verathon recommends that new users:
• Obtain instruction from a qualified individual
• Practice using the stylet on a mannequin before clinical use
• Acquire clinical training experience on patients without airway abnormalities
Operations & Maintenance Manual: Important Information
1
0900-4686 REV-02
Page 8

WARNINGS

Warnings indicate that injury, death, or other serious adverse reactions may result from use or misuse of the device. Please heed the following warnings.
WARNING
WARNING
WARNING
Do not allow the stylet to advance past the vocal cords; the ventilation tube should be advanced off the stylet and into the airway. The stylet must not advance into the glottis under any circumstances.
During use, the stylet should not protrude beyond the end of the endotracheal tube.
Do not use the product if it appears damaged. Inspect the product before each use.
WARNING
This product is not shipped in sterile condition. Clean it, and apply either high-level disinfection or sterilization, before its first use. Failure to do so increases the risk of infection.
WARNING
The stylet is considered a semi-critical device that may come into contact with the airway. It must be thoroughly cleaned and undergo high-level disinfection or sterilization after eachuse.
WARNING
Because the product may be contaminated with human blood or body fluids capable of transmitting pathogens, all cleaning facilities must be in compliance with (U.S.) OSHA Standard 29CFR1910.1030 “Bloodborne Pathogens” or an equivalent standard.
WARNING
This product may only be cleaned, disinfected, or sterilized by using the approved processes provided in the GlideScope and GlideRite Products Reprocessing Manual (part number 0900-5032). Cleaning, disinfection, and sterilization methods listed are recommended by Verathon based on efficacy or compatibility with component materials.
2
0900-4686 REV-02
Page 9
WARNING
To reduce the risk of cytotoxic residual when cleaning with Metrex CaviCide, thoroughly rinse the component as instructed in the GlideScope and GlideRite Products Reprocessing Manual (part number 0900-5032).
WARNING
Verathon has conducted no analysis to establish the compatibility of this product with environments where magnetic resonance imaging (MRI) equipment is installed. Because of this, the owner of this product must exclude it from any magnetic resonance (MR) environment.
Operations & Maintenance Manual: Important Information
3
0900-4686 REV-02
Page 10

INTRODUCTION

The GlideRite Rigid Stylet is specifically designed to work with GlideScope video laryngoscopes. The angle of the GlideRite Rigid Stylet complements the unique angle of the GlideScope instrument to help facilitate quick placement of an endotracheal tube and to help reduce patient trauma.
Figure 1. GlideRite Rigid Stylet and GlideScope Titanium Reusable Video Laryngoscope
FE AT URES
• Provides maneuverability for placement of an endotracheal tube
• Constructed of durable, reusable stainless steel
• Easy to high-level disinfect or sterilize in an autoclave
• Designed for use with endotracheal tubes 6.0mm and larger
• Convenient and cost-effective
• Easy to use, learn, and teach
4
0900-4686 REV-02
Page 11

USING THE STYLET

PRocEdURE 1. USE THE GLIdERITE RIGId STYLET

Do not bend or attempt to reshape the stylet. The shape of the stylet is designed to complement the curve of GlideScope video laryngoscopes.
1. Ensure the stylet has been high-level disinfected or sterilized. For more information, refer to the GlideScope and GlideRite Products Reprocessing Manual, which is available at
verathon.com/product-documentation.
2. Inspect the stylet for damage. If there is any damage, discard it and contact Verathon Customer Care or your local representative to order a new stylet.
3. Load the endotracheal tube onto the stylet. Ensure that the distal end of the stylet does not extend beyond the distal end of the ET tube.
4. Insert the ET tube behind or immediately adjacent to the GlideScope video laryngoscope.
5. Position the ET tube at the opening of the vocal cords. Do not advance the stylet past the vocal cords.
6. When the ET tube is engaged in the glottic opening, extract the stylet 5cm (2in) by pushing up on the thumb tab of the stylet. This partial removal of the stylet from the ET tube softens the tip, allowing the tube to pass through the vocal cords.
5cm (2in)
7. Position the ET tube as per standard practice.
8. Remove the stylet from the ET tube.
9. Optionally, to prevent contaminants from drying onto the surface of the stylet, apply a pre-cleaner. Bodily contaminants tend to become securely attached to solid surfaces when dried, making removal difficult.
Operations & Maintenance Manual: Using the Stylet
5
0900-4686 REV-02
Page 12

REPROCESSING

The GlideRite Rigid Stylet is a reusable device that requires cleaning and either high-level disinfection or sterilization prior to first use and between uses. For information about the cleaning, disinfection, and sterilization requirements for this component, refer to the GlideScope and GlideRite Products Reprocessing Manual, which is available at verathon.com/product-documentation.
6
0900-4686 REV-02
Page 13

PRODUCT SPECIFICATIONS

SPECIFICATIONS

Table 1. GlideRite Rigid Stylet Specifications
GENERAL SPECIFICATIONS
Expected product life: 100cycles
Temperature: 10–40°C (50 –10 4°F)
Operating conditions:
Shipping and storage conditions:

DIMENSIONS

Table 2. GlideRite Rigid Stylet Dimensions
Relative humidity: 10–95%
Atmospheric pressure: 700–1060 hPa
Temperature: -20– 45°C (-4–113°F)
Relative humidity: 10–95%
Atmospheric pressure: 440 –1060 hPa
GLIDERITE RIGID STYLET (0803‑0009)
Specification Value
Handle width (A) 16 mm (0.6 in)
Handle length (B) 84 mm (3.3 in)
Stylet rod length (C) 266 mm (10.5 in)
Distal tip diameter (D) 5 mm (0.2 in)
A
B
C
Operations & Maintenance Manual: Product Specifications
D
7
0900-4686 REV-02
Page 14

GLOSSARY

The following table provides definitions for specialized terms used in this manual or on the product itself. For a full list of caution, warning, and informational symbols used on this and other Verathon products, please refer to the Verathon Symbol Glossary at verathon.com/symbols.
TERM DEFINITION
AER Automated endoscope reprocessor
C Celsius
CFR Code of Federal Regulations (U.S.)
cm Centimeter
CSA Canadian Standards Association
ETT Endotracheal tube
F Fahrenheit
hPa Hectopascal
in Inch
L Liter
mL Milliliter
mm Millimeter
OSHA Occupational Safety and Health Administration (federal agency in U.S.)
Purewater
Water that is suitable for high-level disinfection according to local regulations and your medical facility
8
0900-4686 REV-02
Page 15
Page 16
Loading...