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Operations & Maintenance Manual: Reprocessing

0900‑4868 REV‑08

REPROCESSING

Some of the components in this manual may require cleaning, low‑level disinfection, high‑level
disinfection, or sterilization between uses or under specific circumstances. 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

.

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Summary of Contents for BFlex

Page 1: ...GLIDESCOPE BFLEX SINGLE USE BRONCHOSCOPES WITH GLIDESCOPE VIDEO MONITOR Operations Maintenance Manual ...

Page 2: ...0900 4868 REV 08 ...

Page 3: ... 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: ...5 Australia Within Australia 1800 613 603 Tel 1800 657 970 Fax International 61 2 9431 2000 Tel 61 2 9475 1201 Fax 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...

Page 5: ...nce 1 Environments of Intended Use 2 Statement of Prescription 2 Notice to All Users 2 Warnings Cautions 2 INTRODUCTION 9 System Parts Accessories 10 Language Settings 13 Bronchoscope Components 14 Video Monitor Buttons Icons Connections 15 SETTING UP 18 Perform Initial Inspection 18 Mount the System Optional 19 Charge the Monitor Battery 22 Attach the Cable Bronchoscope 23 Connect to an External ...

Page 6: ...uids or Accessories Optional 34 Procedure 6 Use the Record Snapshot Features Optional 36 Procedure 7 Remove the Bronchoscope 37 Procedure 8 Use the Playback Feature Optional 38 REPROCESSING 39 MAINTENANCE SAFETY 40 Periodic Inspections 40 GlideScope Video Monitor Battery 40 System Software 40 Device Repair 41 Device Disposal 41 WARRANTY 42 PRODUCT SPECIFICATIONS 44 Component Specifications 44 Batt...

Page 7: ...iatric use 6 months to 6 years It has been verified and validated for the following endotracheal tube ETT and endoscope accessory EA sizes MODEL MINIMUM ETT INSIDE DIAMETER EA MINIMUM WORKING CHANNEL WIDTH BFlex 2 8 4 0 mm BFlex 3 8 5 0 mm 1 2 mm BFlex 5 0 6 0 mm 2 1 mm BFlex 5 8 7 0 mm 3 0 mm Note There is no guarantee that instruments selected solely using these instrument dimensions will be com...

Page 8: ...cate that use or misuse of the device may cause a problem such as a malfunction failure or damage to the product WARNINGS USE Before every use ensure that the instrument is operating correctly and has no sign of damage Do not use this product if the device appears damaged Refer servicing to qualified personnel Always ensure that alternative airway management methods and equipment are readily avail...

Page 9: ... damage to or detachment of the distal tip WARNING When using suction limit the vacuum level to 85 kPa 638 mmHg or less Higher vacuum levels may make it difficult to cut off suction if required WARNING Do not use active endoscopic components such as laser probes or electrosurgical devices with this system Such use may result in injury to the patient or damage to the system WARNING Do not introduce...

Page 10: ...display carefully while advancing or withdrawing the bronchoscope flexing the distal tip or applying suction Failure to do so may result in injury to the patient WARNING Before discarding a bronchoscope ensure that no parts of the camera distal tip or insertion tube are missing WARNING WARNINGS CLEANING Do not reuse reprocess or resterilize single use components Reuse reprocessing or resterilizati...

Page 11: ...environmentally hazardous materials When the instrument or accessories have reached the end of their useful service life see the section Device Disposal Dispose of used single use components as infectious waste WARNING Two areas of the bronchoscope tip that contact the patient can exceed 41 C 106 F as part of normal operation The first area is the light emitting area surrounding the camera in the ...

Page 12: ...USB drives powered by another external source WARNING 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 WARNI...

Page 13: ...of interference Reorient or relocate this device or other devices Increase the separation between devices Power off and on the monitor if the image quality is not optimal after removal of the interference Connect the device to an outlet on a circuit different than the other device s Eliminate or reduce EMI with technical solutions such as shielding Purchase medical devices that comply with IEC 606...

Page 14: ...re it is compatible with the working channel of the bronchoscope CAUTION Do not use the system if it is not functioning properly or if it is damaged in any way CAUTION 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 ...

Page 15: ...ntral 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 Figure 1 GlideScope BFlex Single Use System ...

Page 16: ...10 0900 4868 REV 08 SYSTEM PARTS ACCESSORIES Table 1 Required System Components REQUIRED PARTS ACCESSORIES GlideScope Video Monitor ...

Page 17: ...REV 08 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 ...

Page 18: ...12 0900 4868 REV 08 REQUIRED PARTS ACCESSORIES Introducer Video monitor 12V DC power adapter Power cable In service USB flash drive Note Contains instructions for use ...

Page 19: ...basket Note For use with mobile stand HDMI to DVI cable IV pole mounting kit 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 suppo...

Page 20: ...ositioning marks Includes marks at 50 mm intervals to assist in scope placement within the airway 5 Articulating distal tip 6 Suction port Accommodates tubing with an inside diameter between 6 0 and 7 0 mm inclusively 7 Suction button 8 Control lever Positions articulating distal tip 9 Accessory port Enables introduction of accessories or liquids 10 Tube retainer Enables mounting of endotracheal E...

Page 21: ...ds to reset the system Record Press to start and stop recording directly to a USB flash drive that has been inserted in the USB port When you are recording the red LED indicator to the right of the button will be lit and the Recording icon will be shown on the screen The playback menu is not available during recording Note To record video a USB flash drive must be inserted into the monitor USB por...

Page 22: ...SB flash drive has been used When the USB flash drive is full recording stops Incompatible USB Drive The USB flash drive that is plugged into the monitor is not suitable for recording videos This normally occurs when using an encrypted USB flash drive or when using an older inexpensive model that is not capable of the speed necessary to save video in real time USB Flash Drive Not Found A USB flash...

Page 23: ...ng a paused video file Note This option is not available while audio recording is active Pause Pause the video playback Snapshot On the playback menu this icon indicates that a file is a snapshot Video On the playback menu this icon indicates that a file is a video Figure 4 GlideScope Video Monitor Back Panel Video out port Connect the HDMI to DVI cable from the external monitor Video cable port A...

Page 24: ...cable 5 Connect to an External Monitor Optional Connect the monitor to an external display source such as a larger monitor screen by using the HDMI to DVI cable 6 Configure User Settings Enter data customized to your clinic and configure settings such as the date and time 7 Perform a Functional Check Before you use the device for the first time perform a functional check to ensure that the system ...

Page 25: ...om one location to another Mount it on an IV pole Figure 7 Figure 5 GlideScope Premium Cart Figure 6 Mobile Stand Figure 7 IV Pole Mount IV pole mount ATTACH THE MONITOR TO THE CART OR IV POLE 1 If you are using the GlideScope premium cart or mobile stand assemble it according to the instructions included with the component 2 If you are using an IV pole mount place the mounting bracket on the IV p...

Page 26: ...ay 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 5 Using the orientation shown in the following images screw the quick release locking plate to the back panel of the monitor Quick release locking plate 6 Seat the locking plate of the monitor on the quick release mount When properly situ...

Page 27: ...is secures the quick release lever in the locked position Locking pin in locked position ADJUST THE MONITOR ANGLE Before you start using the video monitor adjust the angle of the monitor for optimal viewing The ideal angle minimizes glare and maximizes visibility 9 Turn the angle adjustment knob counterclockwise Angle adjustment knob 10 Tilt the monitor to the desired angle 11 Turn the angle adjus...

Page 28: ...tween 0 35 C 32 95 F The percentage above the Battery Status icon indicates the remaining battery charge Figure 8 Battery Status Icons 19 battery life or less remaining Battery must be charged 20 to 50 battery life remaining 51 to 82 battery life remaining Battery is 83 to fully charged The lightning bolt indicates that the battery is charging 1 Connect the video monitor 12V DC power adapter to th...

Page 29: ...sure that the bronchoscope remains as clean as possible 1 Ensure that the video monitor is turned off 2 Align the arrow on the GlideScope Video Monitor QuickConnect Cable and the arrow on the video cable port 3 Insert the cable connector into the port You will hear a click when the cable is successfully connected 4 Remove the bronchoscope and the introducer from their packets 5 Detach the protecti...

Page 30: ...e during use 9 To disconnect the GlideScope Video Monitor QuickConnect Cable from the monitor rotate the connector ring in the direction of the release arrow and then remove the connector from the port Connector ring 10 To disconnect a bronchoscope from the GlideScope Video Monitor QuickConnect Cable hold the cable connector in one hand and the handle of the bronchoscope in the other and then pull...

Page 31: ...ystem Parts Accessories section on page 10 and the Component Specifications section on page 44 The use of accessories or cables other than those specified or supplied may result in increased emissions or decreased immunity of the system 1 Ensure that the video monitor is turned off 2 On the back of the monitor remove the HDMI cap from the video out port 3 Connect the HDMI end of the cable to the v...

Page 32: ... Power Cycle 370 1 If a USB flash drive is inserted into the monitor remove it 2 Press the Power button The monitor turns on 3 Press and hold the Tutorial button and while continuing to hold it press the Snapshot button within the first 3 seconds The User Settings screen appears on the monitor The configurable user settings are displayed in yellow and the selected setting is highlighted in red 4 C...

Page 33: ...approximately 6 hours 2 Attach a GlideScope Video Monitor QuickConnect Cable and a bronchoscope to the monitor according to the instructions in Attach the Cable Bronchoscope on page 23 3 Press the Power button The monitor turns on 4 Look at the monitor screen and verify that the image displayed is being received from the bronchoscope RECOMMENDED CHECKS 5 On the back of the monitor remove the USB p...

Page 34: ...ing system OS use an application such as one of the following Windows Media Player included with the operating system VLC free at http www videolan org vlc index html If you are viewing the recorded video file on Mac OS use an application such as one of the following MPlayerX free in the App Store VLC free at http www videolan org vlc index html If you are viewing the recorded video file on iOS us...

Page 35: ...low the bronchoscope to warm up for 30 120 seconds prior to use depending on the ambient temperature and humidity of the clinical environment Full warmup is not necessary to use the device if desired you may begin the insertion procedure immediately Using the GlideScope BFlex system consists of the following Prepare the GlideScope System Position the Handle and Controls Insert Through a Tube or Ca...

Page 36: ... The video monitor turns on Note If the GlideScope Video Monitor locks up becomes unresponsive for any reason or does not show an image from the bronchoscope press and hold the Power button for 10 seconds to reboot the system 5 Ensure that the battery is sufficiently charged If necessary connect the monitor directly to power 6 On the monitor screen verify that the image displayed is from the bronc...

Page 37: ...nd turn the insertion tube or to provide additional support as appropriate If you need to do several of these things at once you may need a second person to assist 1 Empty the hand you will use to support and operate the bronchoscope 2 Using that hand grasp the handle in the center 3 Place the positioning lever under your thumb 4 Place the suction button under your index finger Press the button as...

Page 38: ... neutral position 2 Lubricate the scope tube or catheter and then slowly insert the distal tip of the bronchoscope into the internal channel of the tube or catheter If you encounter resistance while inserting the bronchoscope pull the scope back slightly ensure your thumb is not on the positioning lever and then continue inserting the bronchoscope You may choose to apply additional lubrication to ...

Page 39: ...zation stage of manufacturing As you perform the insertion use the following steps to direct the distal tip of the bronchoscope Note If necessary the bronchoscope can be wiped gently with sterile gauze 1 Using your thumb move the positioning lever to flex the distal tip as needed The tip flexes with the lever as shown in the figures to the right 2 As you carefully advance and flex the distal tip r...

Page 40: ...e 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 BFlex 3 8 1 0 mm BFlex 5 0 2 0 mm BFlex 5 8 2 6 mm Use the following steps to introduce liquids or accessories through the working channel...

Page 41: ...IC 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 Insert the distal end of the accessory into the working channel 4 Slide the accessory through the working channel until its end emerges from the distal tip of the bronchoscope as sh...

Page 42: ...hen insert a USB flash drive into the port Note If you do not insert a USB flash drive the video recording audio recording and snapshot features will not be available USB port 2 Ensure that the USB flash drive is detected by checking if the USB Flash Drive icon on the bottom of the screen is displayed 3 If you want to record the intubation press the Record button Video recording starts and is save...

Page 43: ...e Procedure 7 REMOVE THE BRONCHOSCOPE If you intend to insert the bronchoscope into the same patient more than once prepare a sterile resting area for it Keep the bronchoscope in this area when it is not in use 1 When possible retract any accessories into the working channel in order to avoid interference with the distal tip during removal 2 Return the positioning lever as close to center as possi...

Page 44: ...vi 20131101_132217 jpg 20130411_143605 avi 20140110_203355 avi 20140114_203419 avi 20140114_205213 jpg Tutorial 4 Navigate the menu as follows Press the Snapshot button to move up the list of playback files Press the External Video button to move down the list of playback files 5 When you have selected the item that you want to play press the Tutorial button Playback starts 6 When the file is bein...

Page 45: ... disinfection high level disinfection or sterilization between uses or under specific circumstances 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 ...

Page 46: ...tery Specifications on page 51 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 SYSTEM SOFTWARE Vera...

Page 47: ...ormed by a qualified technician If you have any questions contact your local Verathon representative or Verathon Customer Care Please read the Warnings Cautions section DEVICE DISPOSAL The system and related accessories may contain batteries and other environmentally hazardous materials When the instrument has reached the end of its useful service life it must be disposed of in accordance with WEE...

Page 48: ...is warranted to be free from defects in material and workmanship under normal use and services Verathon s warranty does not cover defects or problems caused by the buyer s acts or failure to act the acts of others or events beyond Verathon s reasonable control The buyer shall be solely responsible for any problem failure malfunction defect claim damage liability or safety issue arising out of the ...

Page 49: ...our local representative DISCLAIMER OF ADDITIONAL WARRANTIES There are no understandings agreements representations of warranties expressed or implied including warranties of merchantability or fitness for a particular purpose other than those set forth in this chapter and the Terms and Conditions of Sale The contents of this manual do not constitute a warranty Some states disallow certain limitat...

Page 50: ...e provided power cord has a third prong it is used as a functional ground DC power supply 12 V DC 3 33 A max Ingress protection IP54 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 Screen type and resolution TFT Color V...

Page 51: ... F Relative humidity 10 95 10 95 Atmospheric pressure 700 1060 hPa 440 1060 hPa COMPONENT SPECIFICATIONS Length A 1931 mm A B Diameter B 6 8 mm Table 11 Premium Cart 0800 0537 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 SPECIFICAT...

Page 52: ...hPa COMPONENT SPECIFICATIONS Wheelbase diameter A 61 cm A B C Minimum height B 76 cm Maximum height C 122 cm Table 13 IV Pole Mount 0810 0200 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 Arm length A 27 cm A B C Widt...

Page 53: ...0 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 of flexible insertion tube from distal tip A 610 mm Outside diameter of flexible insertion tube B 2 8 mm Maximum outside diameter of flexible insertion tube and distal tip C 3 3 mm Minimum inside diameter of endotracheal tube 4 0 mm Depth of field D 5 50 mm D...

Page 54: ...f flexible insertion tube and distal tip C 4 4 mm Minimum inside diameter of endotracheal tube 5 0 mm Average Inside diameter of working channel D 1 2 mm Minimum inside diameter of working channel D 1 2 mm Maximum accessory width 1 0 mm Length of working channel 696 mm Volume of working channel 0 98 cc 0 98 mL Depth of field E 5 50 mm Direction of view relative to center line of distal tip 0 Field...

Page 55: ...Maximum outside diameter of flexible insertion tube and distal tip C 5 5 mm Minimum inside diameter of endotracheal tube 6 0 mm Average Inside diameter of working channel D 2 2 mm Minimum inside diameter of working channel D 2 1 mm Maximum accessory width 2 0 mm Length of working channel 696 mm Volume of working channel 2 77 cc 2 77 mL Depth of field E 5 50 mm Direction of view relative to center ...

Page 56: ...f flexible insertion tube and distal tip C 6 35 mm Minimum inside diameter of endotracheal tube 7 0 mm Average Inside diameter of working channel D 3 0 mm Minimum inside diameter of working channel D 3 0 mm Maximum accessory width 2 6 mm Length of working channel 696 mm Volume of working channel 5 2 cc 5 2 mL Depth of field E 5 50 mm Direction of view relative to center line of distal tip 0 Field ...

Page 57: ...m ion Battery life Under normal operating conditions a fully charged battery lasts approximately 90 minutes Charging time Charging time off line will take no more than 6 hours from an empty battery to a full charge Rated capacity 2150 mAh Nominal voltage 7 2 V Max charging voltage 8 4 V Nominal weight 90 g 0 2 lbs Width 23 mm 0 9 in Length 391 mm 5 4 in Thickness 23 mm 0 9 in ...

Page 58: ...deScope BFlex system see Essential Performance on page 1 ELECTROMAGNETIC EMISSIONS Table 19 Guidance and Manufacturer s Declaration Electromagnetic Emissions 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 EMISSIONS TEST COMPLIANCE ELECTROMAGNETIC ENVIRONMENT GUIDANCE RF em...

Page 59: ...lity should be that of a typical hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 0 UT 0 5 Cycle At 0 45 90 135 180 225 270 and 315 0 UT 1 cycle and 70 UT 25 30 cycles Single Phase at 0 In compliance Mains power quality should be that of a typical hospital environment If the user of the system requires continued operation durin...

Page 60: ...t apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 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 secti...

Page 61: ...adio Interference cm Centimeter CSA Canadian Standards Association DL Direct laryngoscopy DLT Double Lumen tube EMI Electromagnetic interference ESD Electrostatic discharge Essential performance The system performance necessary to achieve freedom from unacceptable risk ET Tube Endotracheal tube F Fahrenheit g Gram GHz Gigahertz HDMI High definition multimedia interface hPa Hectopascal Hz Hertz IEC...

Page 62: ...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 Pounds per square inch absolute RF Radio frequency RH Relative humidity RoHS Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment SDS Sodium dodecyl sulphate V Volt Vrms Voltage root mean squa...

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