Related Manuals for Verathon GLIDESCOPE BFLEX
Summary of Contents for Verathon GLIDESCOPE BFLEX
- Page 1 GLIDESCOPE BFLEX SINGLE‑USE BRONCHOSCOPES WITH GLIDESCOPE VIDEO MONITOR Operations & Maintenance Manual...
- Page 2 0900‑4868 REV‑08...
- Page 3 GLIDESCOPE BFLEX SINGLE‑USE BRONCHOSCOPES WITH GLIDESCOPE VIDEO MONITOR Operations & Maintenance Manual Effective: April 8, 2022 Caution: Federal (United States) law restricts this device to sale by or on the order of a physician.
- Page 4 0123 Copyright © 2022 by Verathon Inc. All rights reserved. No part of this manual may be copied or transmitted by any method without the express written consent of Verathon Inc. GlideScope, BFlex, Verathon, and the associated symbols are trademarks of Verathon Inc. All other brand and product names are trademarks or registered trademarks of their respective owners.
-
Page 5: Table Of Contents
TABLE OF CONTENTS IMPORTANT INFORMATION ..........................1 Product Description ............................1 Statement of Intended Use ..........................1 Intended Patient Population ..........................1 Intended Use Environment and User Population ....................1 Contraindications ..............................1 Essential Performance ............................1 Environments of Intended Use..........................2 Statement of Prescription ............................2 Notice to All Users ..............................2 Warnings &... - Page 6 USING THE DEVICE .............................29 Procedure 1. Prepare the GlideScope System ....................30 Procedure 2. Position the Handle and Controls ..................31 Procedure 3. Insert Through a Tube or Catheter (Optional) ...............32 Procedure 4. Insert and Flex the Bronchoscope ..................33 Procedure 5. Introduce Liquids or Accessories (Optional) ................34 Procedure 6.
-
Page 7: Important Information
Note: There is no guarantee that instruments selected solely using these instrument dimensions will be compatible in combination. INTENDED USE ENVIRONMENT AND USER POPULATION The GlideScope BFlex Single‑Use bronchoscope is intended for in‑hospital use by physicians trained in the use of endoscopic equipment. CONTRAINDICATIONS The GlideScope BFlex 2.8 Single‑Use Bronchoscope does not have a working channel and therefore cannot... -
Page 8: Environments Of Intended Use
ENVIRONMENTS OF INTENDED USE The GlideScope BFlex Single‑Use Bronchoscope system is intended to be used in professional healthcare environments such as hospitals. STATEMENT OF PRESCRIPTION Caution: Federal (United States) law restricts this device to sale by or on the order of a physician. - Page 9 WARNING Do not use this system during defibrillation. WARNING Do not use the power adapter in the presence of flammable anesthetics. WARNING Do not use this system to deliver highly flammable anaesthetic gases to the patient. Such use may result in patient injury. WARNING Do not use excessive force when inserting, positioning, or removing the single‑use bronchoscope or accessories.
- Page 10 WARNING QuickConnect Cable, Monitor, and Cart Only: Availability of cleaning products varies by country, and Verathon is unable to test products in every market. For more information, please contact Verathon Customer Care. For contact information, visit verathon.com/global‑support. 0900‑4868 REV‑08...
- Page 11 GlideScope and GlideRite Products Reprocessing Manual (part number 0900‑5032). Cleaning and disinfection methods listed are recommended by Verathon based on efficacy or compatibility with component materials. WARNING QuickConnect Cable, Monitor, and Cart Only: For information on the handling and disposing of recommended reprocessing solutions, please refer to the solution manufacturer’s instructions.
- Page 12 Monitor Only: The external monitor must be safety‑approved medical equipment. WARNING Use of accessories and cables other than those specified or provided by Verathon may cause this system to experience electromagnetic malfunctions, including increased emissions or decreased immunity. This may cause improper operation, procedure delays, or both.
- Page 13 CAUTIONS CAUTION Medical electrical equipment requires special precautions regarding electromagnetic compatibility (EMC) and must be installed and operated according to the instructions in this manual. For more information, see the Electromagnetic Compatibility section. Avoid using the GlideScope system adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, observe the system to verify normal operation in the configuration in which it will be used.
- Page 14 Do not store BFlex pouches in direct sunlight. CAUTION European Union only: If any serious incident occurs during use of this product, you must immediately notify both Verathon and the Competent Authority of the Member State where the incident occurred. 0900‑4868 REV‑08...
-
Page 15: Introduction
INTRODUCTION The GlideScope BFlex Single‑Use Bronchoscope system incorporates the following central components: • GlideScope BFlex bronchoscope (single‑use) • GlideScope Video Monitor QuickConnect Cable (reusable) • GlideScope Video Monitor (reusable) The system also includes the cables and adapters to power the monitor, and it may include optional system components that simplify use or provide convenience to the user. -
Page 16: System Parts & Accessories
SYSTEM PARTS & ACCESSORIES Table 1. Required System Components REQUIRED PARTS & ACCESSORIES GlideScope Video Monitor 0900‑4868 REV‑08... - Page 17 REQUIRED PARTS & ACCESSORIES GlideScope BFlex 2.8 Single‑Use bronchoscope GlideScope BFlex 3.8 Single‑Use bronchoscope GlideScope BFlex 5.0 Single‑Use bronchoscope GlideScope BFlex 5.8 Single‑Use bronchoscope GlideScope Video Monitor QuickConnect Cable Operations & Maintenance Manual: Introduction 0900‑4868 REV‑08...
- Page 18 REQUIRED PARTS & ACCESSORIES Introducer Video monitor 12V DC power adapter Power cable In‑service USB flash drive Note: Contains instructions for use. 0900‑4868 REV‑08...
-
Page 19: Language Settings
The video monitor software is available in a variety of languages. To change the language used on your system, you must install a new software version via a USB flash drive. For more information, contact Verathon Customer Care or your local representative. For contact information, see verathon.com/global‑support. -
Page 20: Bronchoscope Components
BRONCHOSCOPE COMPONENTS The GlideScope BFlex bronchoscope is a single‑use device that can be inserted either directly or through an endotracheal (ET) tube. The main components of the bronchoscope are shown in the following figure. Figure 2. Bronchoscope Components Table 3. -
Page 21: Video Monitor Buttons, Icons, & Connections
3‑second delay, press the Snapshot button to enter the User Settings screens. Battery Indicator: LED is: Green: Unit fully charged Red: Unit charging Flashing Red: Indicates a problem with the battery. Charge for 6 hours, and if still flashing, contact Verathon Customer Care. Operations & Maintenance Manual: Introduction 0900‑4868 REV‑08... - Page 22 Table 5. On‑Screen Icons ICON FUNCTION Battery Status: The remaining battery power is indicated by the Battery Status icon and the percentage above the icon. If the icon is red, the battery should be charged as soon as possible. (See Charge the Monitor Battery on page 22.) While the battery is being charged, a lightning bolt will be displayed alongside the...
- Page 23 ICON FUNCTION Hourglass: Please wait while the system prepares for the next action. Audio Recording is Active: Audio is being recorded on the video. Note: The default for audio recording is OFF. Audio recording on the video occurs only if the setting has been changed to ON in user settings. Back Arrow: Exit to previous screen.
-
Page 24: Setting Up
1. Verify that you have received the appropriate components for your system by referring to the packing list included with the system. 2. Inspect the components for damage. 3. If any of the components are missing or damaged, notify the carrier and Verathon Customer Care or your local representative. For contact information, visit verathon.com/global‑support. 0900‑4868 REV‑08... -
Page 25: Mount The System (Optional)
MOUNT THE SYSTEM (OPTIONAL) If you choose to mount the system, you may use either of the following configurations: • Mount it on a GlideScope premium cart or mobile stand (Figure 5 Figure 6). These solutions make it easy for you to move the system from one location to another. •... - Page 26 3. On the cart mount or the IV pole mount, ensure that the locking pin and quick‑release lever are in the unlocked (horizontal) position. Quick‑release lever in unlocked position Locking pin in unlocked position 4. While holding the quick‑release locking plate with the head of the mounting screw facing away from you and the larger of the two flanges to your left, Insert a positioning pin into the right‑hand hole on the locking plate as shown in the following image.
- Page 27 7. Ensure that the quick‑release lever is fully in the locked (down) position. This secures the monitor in place. Quick‑release lever in locked position 8. Adjust the locking pin to the locked (down) position. This secures the quick‑release lever in the locked position.
-
Page 28: Charge The Monitor Battery
CHARGE THE MONITOR BATTERY The GlideScope Video Monitor includes an internal lithium‑ion battery. Verathon recommends that you charge the battery fully prior to first use. Under normal operating conditions, a fully charged battery lasts approximately 90 minutes before it needs to be recharged. For optimal battery life, ensure that the battery is fully charged before you try to use the monitor in battery mode. -
Page 29: Attach The Cable & Bronchoscope
ATTACH THE CABLE & BRONCHOSCOPE The GlideScope Video Monitor QuickConnect Cable attaches the bronchoscope to the monitor, supplying power to the bronchoscope and transmitting video data from the camera to the monitor. It is recommended that you leave the sterile, single‑use bronchoscope in the packaging while connecting it, and that you do not remove the bronchoscope until you are ready to insert it. - Page 30 8. Align the white dot on the opposite end of the GlideScope Video Monitor QuickConnect Cable with the dot on the bronchoscope, and then insert the connector into the bronchoscope. Magnets in both components hold them in place during use. 9.
-
Page 31: Connect To An External Monitor (Optional)
Note: Image quality on the external monitor may vary according to the resolution of the external monitor. Note: To maintain electromagnetic interference (EMI) within certified limits, the GlideScope BFlex system must be used with the cables, components, and accessories specified or supplied by Verathon. For additional information, see the System Parts &... -
Page 32: Configure User Settings
CONFIGURE USER SETTINGS You may configure the following settings directly on the unit: • Date and Time • Audio Recording • Date and Time Format • Auto Recording • Key Click Sound • Auto External Video • Auto Power Off •... -
Page 33: Perform A Functional Check
PERFORM A FUNCTIONAL CHECK Before you use the device for the first time, perform the following functional check to ensure that the system is working properly. Please contact your Verathon Customer Care representative if your system does not function as described below. - Page 34 7. Press the Record button . Recording starts. 8. To stop recording, press the Record button again. 9. Wait until the Saving File icon has disappeared from the screen, and then remove the USB flash drive from the monitor. 10. On a computer, verify that the recorded video (.avi) file can be played. Note: If you are viewing the recorded file on a Windows operating system (OS), use an application such as one of the following:...
-
Page 35: Using The Device
Warnings & Cautions section before performing the following tasks. GlideScope BFlex Single‑Use bronchoscopes are equipped with an anti‑fog feature that reduces camera fogging during use. To optimize the feature fully, you must allow the bronchoscope to warm up for 30–120 seconds prior to use, depending on the ambient temperature and humidity of the clinical environment. -
Page 36: Procedure 1. Prepare The Glidescope System
PROCEDURE 1. PREPARE THE GLIDESCOPE SYSTEM In this procedure, you turn the system on and verify that it is functioning properly. 1. Ensure that each GlideScope system component has been properly cleaned. 2. Attach the GlideScope Video Monitor QuickConnect Cable and the bronchoscope to the monitor, according to the instructions in Attach the Cable &... -
Page 37: Procedure 2. Position The Handle And Controls
PROCEDURE 2. POSITION THE HANDLE AND CONTROLS With your supporting hand positioned as described in this procedure, you can regulate suction with your index finger and position the distal tip of the bronchoscope with your thumb. You can then use your other hand to introduce accessories or liquids through the working channel, to grasp and turn the insertion tube, or to provide additional support as appropriate. -
Page 38: Procedure 3. Insert Through A Tube Or Catheter (Optional)
INSERT THROUGH A TUBE OR CATHETER (OPTIONAL) IMPORTANT Verathon has tested compatibility with water based, silicone based, and petroleum based lubricants. The bronchoscope can be inserted through a tube or catheter with a compatible inside diameter, as shown in the following table. -
Page 39: Procedure 4. Insert And Flex The Bronchoscope
The bronchoscope can be inserted using any standard oral or nasal insertion technique, with or without the use of a separate ET tube. During use, its distal tip can flex through the ranges shown in the following table. Table 7. GlideScope BFlex Bronchoscope—Distal Tip Articulation SIZE RANGE OF MOVEMENT OF DISTAL TIP BFlex 2.8... -
Page 40: Procedure 5. Introduce Liquids Or Accessories (Optional)
The following table shows the maximum diameter of tools and accessories that can be used with each size of bronchoscope. Table 8. GlideScope BFlex Bronchoscope—Tool and Accessory Compatibility SIZE MAXIMUM ACCESSORY WIDTH BFlex 2.8 Not applicable. No working channel. - Page 41 3. Dispense the liquid into the working channel. Note: If suction is connected to the bronchoscope, do not apply suction while you are introducing the liquid. This causes the suction to withdraw the liquid from the bronchoscope. Conversely, to ensure full suction strength, retract the syringe or introducer while applying suction.
-
Page 42: Procedure 6. Use The Record & Snapshot Features (Optional)
PROCEDURE 6. USE THE RECORD & SNAPSHOT FEATURES (OPTIONAL) Please read the Warnings & Cautions section before performing the following task. The system is equipped with video and audio recording features and the ability to save a snapshot of the live display on the monitor. -
Page 43: Procedure 7. Remove The Bronchoscope
6. If you would like to review the recorded files on the video monitor, complete the steps in the procedure Use the Playback Feature (Optional). on page 38. If you would like to review the recorded files on a computer, insert the USB flash drive into the PC, and then view the .avi or .jpg files. -
Page 44: Procedure 8. Use The Playback Feature (Optional)
PROCEDURE 8. USE THE PLAYBACK FEATURE (OPTIONAL) Recorded videos and snapshots on a USB flash drive can be viewed on the GlideScope Video Monitor. Note: The monitor cannot play back videos or display snapshots while a recording is in process. 1. -
Page 45: Reprocessing
For information about the cleaning, disinfection, and sterilization requirements for these components, refer to the GlideScope and GlideRite Products Reprocessing Manual (part number 0900‑5032), which is available at verathon.com/product‑documentation. Operations & Maintenance Manual: Reprocessing 0900‑4868 REV‑08... -
Page 46: Maintenance & Safety
The battery is not user‑replaceable. In case of battery malfunction, do not attempt to replace the monitor battery. Any attempts to replace the battery by unauthorized service technicians may cause serious harm to the user and will void the warranty. Please contact your Verathon Customer Care representative for more information on battery replacement. -
Page 47: Device Repair
DEVICE REPAIR The system components are not user‑serviceable. Verathon does not make available any type of circuit diagrams, component parts lists, descriptions, or other information that would be required for repairing the device and related accessories. All service must be performed by a qualified technician. -
Page 48: Warranty
Verathon warrants the system against defects in material and workmanship. The limited warranty applies for one (1) year from the date of shipment from Verathon and applies only to the original purchaser of the system. The terms of this warranty are subject to the Terms and Conditions of Sale or any other contractual document between the parties. - Page 49 The information, descriptions, recommendations, and safety notations in this manual are based upon Verathon experience and judgment. The contents of this manual should not be considered to be all‑inclusive or to cover all contingencies.
-
Page 50: Product Specifications
PRODUCT SPECIFICATIONS COMPONENT SPECIFICATIONS Please read the Warnings & Cautions section. Table 9. GlideScope Video Monitor (0570‑0338) GENERAL SPECIFICATIONS Classification: Electrical Class II, Applied Part BF Range: 100–240 VAC, 50 and 60 Hz. Connect to a medical‑grade power supply (If Line voltage: the provided power cord has a third prong, it is used as a functional ground). - Page 51 Table 10. GlideScope Video Monitor QuickConnect Cable (0600‑0781) GENERAL SPECIFICATIONS Ingress protection: IPX7 OPERATING & STORAGE SPECIFICATIONS Operating Conditions Shipping & Storage Conditions Temperature: 10–40°C (50–104°F) ‑20–45°C (‑4–113°F) Relative humidity: 10–95% 10–95% Atmospheric pressure: 700–1060 hPa 440‑1060 hPa COMPONENT SPECIFICATIONS Length (A) 1931 mm Diameter (B)
- Page 52 Table 12. Mobile Stand (0800‑0410) OPERATING & STORAGE SPECIFICATIONS Operating Conditions Shipping & Storage Conditions Temperature: 10–40°C (50–104°F) ‑20–45°C (‑4–113°F) Relative humidity: 10–95% 10–95% Atmospheric pressure: 700–1060 hPa 440‑1060 hPa COMPONENT SPECIFICATIONS Wheelbase diameter (A) 61 cm B–C Minimum height (B) 76 cm Maximum height (C) 122 cm...
- Page 53 Table 14. BFlex 2.8 (0570‑0419) GENERAL SPECIFICATIONS Ingress protection: IPX0 Expected product life: Refer to the “use by” date indicated by the symbol on the package label. OPERATING & STORAGE SPECIFICATIONS Operating Conditions Shipping & Storage Conditions Temperature: 10–40°C (50–104°F) ‑20–45°C (‑4–113°F) Relative humidity: 10–95%...
- Page 54 Table 15. BFlex 3.8 (0570‑0380) GENERAL SPECIFICATIONS Ingress protection: IPX0 Expected product life: Refer to the “use by” date indicated by the symbol on the package label. OPERATING & STORAGE SPECIFICATIONS Operating Conditions Shipping & Storage Conditions Temperature: 10–40°C (50–104°F) ‑20–45°C (‑4–113°F) Relative humidity: 10–95%...
- Page 55 Table 16. BFlex 5.0 (0570‑0374) GENERAL SPECIFICATIONS Ingress protection: IPX0 Expected product life: Refer to the “use by” date indicated by the symbol on the package label. OPERATING & STORAGE SPECIFICATIONS Operating Conditions Shipping & Storage Conditions Temperature: 10–40°C (50–104°F) ‑20–45°C (‑4–113°F) Relative humidity: 10–95%...
- Page 56 Table 17. BFlex 5.8 (0570‑0381) GENERAL SPECIFICATIONS Ingress protection: IPX0 Expected product life: Refer to the “use by” date indicated by the symbol on the package label. OPERATING & STORAGE SPECIFICATIONS Operating Conditions Shipping & Storage Conditions Temperature: 10–40°C (50–104°F) ‑20–45°C (‑4–113°F) Relative humidity: 10–95%...
-
Page 57: Battery Specifications
BATTERY SPECIFICATIONS Table 18. Monitor Battery Specifications CONDITION DESCRIPTION Battery type Lithium‑ion Under normal operating conditions, a fully charged battery lasts Battery life approximately 90 minutes Charging time off line will take no more than 6 hours from an empty battery Charging time to a full charge Rated capacity 2150 mAh... -
Page 58: Electromagnetic Compatibility
ELECTROMAGNETIC COMPATIBILITY The GlideScope BFlex system is designed to be in compliance with IEC 60601‑1‑2, which contains electromagnetic compatibility (EMC) requirements for medical electrical equipment. The limits for emissions and immunity specified in this standard are designed to provide reasonable protection against harmful interference in a typical medical installation. - Page 59 ELECTROMAGNETIC IMMUNITY Table 20. Guidance and Manufacturer’s Declaration —Electromagnetic Immunity The system is intended for use in the electromagnetic environment specified below. The customer or the user of the system should ensure that it is used in such an environment. COMPLIANCE ELECTROMAGNETIC ENVIRONMENT IMMUNITY TESTS...
- Page 60 ACCESSORY CONFORMANCE TO STANDARDS To maintain electromagnetic interference (EMI) within certified limits, the system must be used with the cables, components, and accessories specified or supplied by Verathon. For additional information, see the System Parts & Accessories section on page 10 and Component Specifications section on page 44.
-
Page 61: 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 Directory at verathon.com/symbols. - Page 62 TERM DEFINITION Medical Device Directive Megahertz Milliliter Millimeter mmHg Millimeters of mercury MSDS Material Safety Data Sheet non‑powered accessory Endoscopic tool that does not require its own source of electrical power OSHA Occupational Safety and Health Administration (federal agency in U.S.) powered accessory Endoscopic tool that requires its own source of electrical power psia...