Verathon GLIDESCOPE BFlex Series Operation & Maintenance Manual
  1. Manuals
  2. Brands
  3. Verathon Manuals
  4. Diagnostic Equipment
  5. GLIDESCOPE BFlex Series
  6. Operation & maintenance manual

Verathon GLIDESCOPE BFlex Series Operation & Maintenance Manual

Single‑use bronchoscopes for glidescope core
Hide thumbs
Table of Contents

Advertisement

Quick Links

GLIDESCOPE BFLEX
SINGLE‑USE BRONCHOSCOPES FOR
GLIDESCOPE CORE
Operations & Maintenance Manual

Advertisement

Table of Contents
loading

Related Manuals for Verathon GLIDESCOPE BFlex Series

Summary of Contents for Verathon GLIDESCOPE BFlex Series

  • Page 1 GLIDESCOPE BFLEX SINGLE‑USE BRONCHOSCOPES FOR GLIDESCOPE CORE Operations & Maintenance Manual...
  • Page 2 0900-4939-ETEE REV-03...
  • Page 3 GLIDESCOPE BFLEX SINGLE‑USE BRONCHOSCOPES FOR GLIDESCOPE CORE Operations & Maintenance Manual Effective: January 24, 2020 Caution: Federal (United States) law restricts this device to sale by or on the order of a physician.
  • Page 4 International: +61 2 9431 2000 Tel / +61 2 9475 1201 Fax Copyright © 2020 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.

  • Page 5: Table Of Contents

    TABLE OF CONTENTS IMPORTANT INFORMATION ..........................1 Product Description ............................1 Kasutusotstarve ..............................1 Intended Patient Population ..........................1 Intended Use Environment and User Population ....................1 Essential Performance ............................1 Environments of Intended Use..........................2 Statement of Prescription ............................2 Notice to All Users ..............................2 Hoiatused ja ettevaatusabinõud ..........................2 INTRODUCTION ..............................9 Parts &...
  • Page 6 CLEANING ................................21 HOOLDUS JA OHUTUS ............................22 Korralised kontrollid ............................22 Seadme parandamine ............................22 Seadme kõrvaldamine ............................22 WARRANTY.................................23 PRODUCT SPECIFICATIONS ..........................25 Specifications, Standards, and Approvals ......................25 Component Specifications ..........................25 Electromagnetic Compatibility ...........................29 GLOSSARY ................................32 0900-4939-ETEE REV-03...

  • Page 7: Important Information

    IMPORTANT INFORMATION PRODUCT DESCRIPTION The GlideScope BFlex Single-Use bronchoscope system includes the following components: • Single-use bronchoscope • Reusable monitor • Reusable cable The GlideScope BFlex device is a single-use bronchoscope which, when connected to a video monitor through a reusable cable, is intended to provide real time viewing and recording for a wide range of airway procedures.

  • Page 8: Environments Of Intended Use

    Süsteemi loodud ja kasutatavad videosignaalid on mõeldud ainult seadme positsioneerimiseks. Ärge kasutage süsteemi mistahes patoloogia ainsa diagnostilise meetodina. HOIATUS Verathon ei ole analüüsinud süsteemi sobivust keskkondadega, kuhu on paigaldatud magnetresonantstomograafia seadmed. Seetõttu peab süsteemi omanik vältima seadme sattumist magnetresonantskeskkonda. 0900-4939-ETEE REV-03...
  • Page 9 HOIATUS Ärge kasutage seda süsteemi patsiendile väga tuleohtlike anesteetiliste gaaside manustamiseks. Selline kasutamine võib patsienti vigastada. HOIATUS Ärge kasutage seda süsteemi defibrillatsiooni ajal. HOIATUS Ärge kasutage ühekordselt kasutatava bronhoskoobi või tarvikute sisestamisel, paigutamisel või eemaldamisel liiga palju jõudu. HOIATUS Imemisel ärge ületage vaakumi rõhutaset 85 kPa (638 mmHg). Vaakumi suurema rõhutaseme korral võib imemise katkestamine olla raskendatud.
  • Page 10 Ärge kasutage, töödelge ega steriliseerige ühekordselt kasutatavaid komponente korduvalt. Korduval kasutamisel, töötlemisel või steriliseerimisel võib tekkida seadme saastumise oht. HOIATUS Ainult seoses kaabliga QuickConnect. Puhastustoodete saadavus on riigiti erinev ja Verathon ei suuda igal turul saadavaid tooteid katsetada. Küsige lisateavet Verathoni klienditeeninduselt. Vaadake kontaktteavet veebilehelt verathon.com/global-support.
  • Page 11 HOIATUS Ainult seoses kaabliga QuickConnect. Teavet soovitatavate töötlemislahuste käsitsemise ja kõrvaldamise kohta vaadake lahuse tootja juhistest. HOIATUSED: TOOTEOHUTUS HOIATUS See vahend ja seotud seadmed võivad hõlmata akusid või muid keskkonnaohtlikke materjale. Kui vahend või tarvikute kasutusiga on lõppenud, vt seadme kõrvaldamise jaotist. Käidelge kasutatud ühekordselt kasutatavaid komponente nakkusohtlike jäätmetena.
  • Page 12 Kaasaskantavaid raadiosideseadmeid (sh välisseadmeid, nt antennikaableid ja välisantenne) ei tohi kasutada kuni 30 cm (12 tolli) kaugusel ühekordselt kasutatava bronhoskoobisüsteemi GlideScope BFlex mistahes osast, k.a kaablitest, mille Verathon on määranud või mida Verathon pakub kasutamiseks selle süsteemiga. Kui seda kaugust ei hoita, võib süsteemi toimivus halveneda ja pildi kuvamine häiruda.
  • Page 13 ETTEVAATUSABINÕUD ETTEVAATUST Elektriliste meditsiiniseadmete kasutamisel on vaja elektromagnetilise ühilduvuse (EMC) tagamiseks rakendada erilisi ettevaatusabinõusid ning need seadmed tuleb paigaldada ja neid tuleb kasutada selles juhendis esitatud juhiste järgi. Vaadake lisateavet elektromagnetilise ühilduvuse jaotisest. Vältige süsteemi GlideScope kasutamist teiste seadmete kõrval või nendega virnastatuna. Kui külgnev või virnastatud kasutamine on vajalik, jälgige süsteemi, et kontrollida selle normaalset talitlust konfiguratsioonis, milles seda kasutatakse.
  • Page 14 ETTEVAATUST Enne endoskoopilise tarviku kasutamist veenduge, et see ühilduks bronhoskoobi töökanaliga. ETTEVAATUST Ärge kasutage süsteemi, kui see ei tööta korralikult või on mingil viisil kahjustatud. 0900-4939-ETEE REV-03...

  • Page 15: Introduction

    INTRODUCTION This manual discusses the following components of the GlideScope BFlex Single-Use Bronchoscope system: • GlideScope BFlex bronchoscope (single-use) • GlideScope Core QuickConnect Cable (reusable) Note: This manual covers the single‑use bronchoscope and the reusable cables. For information about using a video monitor, refer to that monitor's Operations &...

  • Page 16: Parts & Accessories

    PARTS & ACCESSORIES Table 1. System Components PARTS & ACCESSORIES GlideScope BFlex 3.8 Single-Use bronchoscope GlideScope BFlex 5.0 Single-Use bronchoscope GlideScope BFlex 5.8 Single-Use bronchoscope GlideScope Core QuickConnect Cable Introducer 0900-4939-ETEE REV-03...

  • Page 17: 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 2. Bronchoscope Component Descriptions FIGURE KEY COMPONENT...

  • Page 18: Setting Up

    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. ATTACH THE VIDEO CABLE TO THE MONITOR This procedure provides basic instruction on connecting video cables to a monitor.

  • Page 19: Attach The Bronchoscope To The Video Cable

    ATTACH THE BRONCHOSCOPE TO THE VIDEO CABLE The GlideScope 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 20: 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 21: Using The Device

    USING THE DEVICE Before use, set up the device according to the instructions in the previous chapter, and verify the setup by completing the procedure Perform a Functional Check on page 14. Please read the Hoiatused ja ettevaatusabinõud section before performing the following tasks. GlideScope BFlex Single-Use bronchoscopes are equipped with an anti-fog feature that reduces camera fogging during use.

  • Page 22: 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 23: Procedure 3. Insert Through A Tube Or Catheter (Optional)

    PROCEDURE 3. INSERT THROUGH A TUBE OR CATHETER (OPTIONAL) The bronchoscope can be inserted through a tube or catheter with a compatible inside diameter, as shown in the following table. Table 3. GlideScope BFlex Bronchoscope—Endotracheal Tube Compatibility TUBES AND CATHETERS BFLEX 3.8 BFLEX 5.0 BFLEX 5.8...

  • Page 24: Procedure 4. Insert And Flex The Bronchoscope

    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 4.

  • Page 25: Procedure 5. Introduce Liquids Or Accessories (Optional)

    PROCEDURE 5. INTRODUCE LIQUIDS OR ACCESSORIES (OPTIONAL) Please read the Hoiatused ja ettevaatusabinõud section before performing the following task. In addition to supplying suction, the working channel on the bronchoscope also provides a delivery channel for the following items: • Liquids such as sterile saline solution •...

  • Page 26: Procedure 6. Remove The Bronchoscope

    OptiOn 2. intRODUCinG nOn‑pOWERED EnDOSCOpiC ACCESSORiES 1. Move the positioning lever in order to return the distal tip as close to a straight position as possible. 2. If appropriate, position the accessory so that its distal end is collapsed as far as possible. 3.

  • Page 27: Cleaning

    For information about the cleaning, disinfection, and sterilization requirements for these components, refer to the GlideScope and GlideRite Products Reprocessing Manual, which is available at verathon.com/product-documentation. Operations & Maintenance Manual: Cleaning 0900-4939-ETEE REV-03...

  • Page 28: Hooldus Ja Ohutus

    SEADME PARANDAMINE Kaablid ei ole kasutajate hooldatavad. Verathon ei avalda ühtegi elektriskeemi, komponentide ja osade loendit, kirjeldust ega muud teavet, mida oleks vaja seadme ja selle tarvikute parandamiseks. Kõik hooldustööd peab tegema kvalifitseeritud tehnik. Kui teil on küsimusi, võtke ühendust Verathoni kohaliku esindaja või Verathoni klienditeenindusega.

  • Page 29: 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 30 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 31: Product Specifications

    PRODUCT SPECIFICATIONS SPECIFICATIONS, STANDARDS, AND APPROVALS Table 6. Specifications GENERAL SPECIFICATIONS Single-use bronchoscope IPX0 Ingress protection against water: QuickConnect Cable (all) IPX7 BFlex 3.8 Refer to the “use by” date Single-use Expected product life: BFlex 5.0 indicated by the symbol on bronchoscope the package label.
  • Page 32 BFLEX 3.8 (0570‑0380) Specification Value Length of flexible insertion tube from distal tip (A) 610 mm Outside diameter of flexible insertion tube (B) 3.8 mm Maximum outside diameter of flexible insertion tube and distal tip (C) 4.4 mm Minimum inside diameter of endotracheal tube 5.0 mm Minimum inside diameter of working channel (D) 1.2 mm...
  • Page 33 BFLEX 5.0 (0570‑0374) Specification Value Length of flexible insertion tube from distal tip (A) 610 mm Outside diameter of flexible insertion tube (B) 5.0 mm Maximum outside diameter of flexible insertion tube and distal tip (C) 5.5 mm Minimum inside diameter of endotracheal tube 6.0 mm Minimum inside diameter of working channel (D) 2.1 mm...
  • Page 34 BFLEX 5.8 (0570‑0381) Specification Value Length of flexible insertion tube from distal tip (A) 610 mm Outside diameter of flexible insertion tube (B) 5.8 mm Maximum outside diameter of flexible insertion tube and distal tip (C) 6.35 mm Minimum inside diameter of endotracheal tube 7.0 mm Minimum inside diameter of working channel (D) 3.0 mm...

  • Page 35: 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 36 ELECTROMAGNETIC IMMUNITY Table 9. 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 37 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 Parts & Accessories section on page 10 and Component Specifications section on page 25.

  • Page 38: 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 39 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...

This manual is also suitable for:

Glidescope bflex 3.8Glidescope bflex 5.0Glidescope bflex 5.8

Table of Contents