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BIOMET innerVue II Operation And Care Manual

Diagnostic scope system
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Operation and Care Manual

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Summary of Contents for BIOMET innerVue II

  • Page 1 Operation and Care Manual...
  • Page 2 InnerVue II Diagnostic Scope System ™ IMPORTANT The InnerVue II Diagnostic Scope System is indicated to provide illumination ™ and visualization of anatomy in an interior cavity of the body through a natural or surgical opening. This device is indicated for diagnostic and operative arthroscopic and endoscopic procedures.

  • Page 3: Table Of Contents

    Operation and Care Manual Table of Contents Introduction The InnerVue II Diagnostic Scope System ™ Indications for Use Contraindications Regulatory Compliance 1.4.1 Electromagnetic Compatibility Chart Warranty Information How to Use This Manual Manual Conventions List of Symbols Product Specifications Contents Features and Specifications 2.2.1 InnerVue II Diagnostic Scope System Features...

  • Page 4: Introduction

    InnerVue II Diagnostic Scope System ™ Introduction Thank you for your purchase of the InnerVue II Diagnostic Scope System. This piece ™ of equipment is designed and built to give you the latest technology and the best performance. This manual will help you make the most of your equipment investment.

  • Page 5: Indications For Use

    Operation and Care Manual Introduction 1.2 Indications for Use The InnerVue II Diagnostic Scope System is indicated to be used by a trained ™ physician to provide illumination and visualization of an interior cavity of the body through a natural or surgical opening in diagnostic and operative arthroscopic and endoscopic procedures.
  • Page 6 InnerVue II Diagnostic Scope System ™ Introduction Guidance and Manufacturer’s Declaration—Electromagnetic Immunity The InnerVue II Diagnostic Scope System is intended for use in the electromagnetic environment speci- ™ fied below. The customer or the user of the InnerVue II Diagnostic Scope System should assure that it is ™...
  • Page 7 Operation and Care Manual Introduction Guidance and Manufacturer’s Declaration—Electromagnetic Immunity The InnerVue II Diagnostic Scope System is intended for use in the electromagnetic environment speci- ™ fied below. The customer or the user of the InnerVue II Diagnostic Scope System should assure that it is ™...

  • Page 8: Warranty Information

    II Diagnostic Scope System is warranted to be free from defects in ™ material or workmanship for one year from the date of shipment from Biomet Sports Medicine to the end user. Within the above listed time periods, parts that are returned, freight prepaid, to...
  • Page 9 The warranty period for replacement parts shall begin upon shipment of same, but shall in no event exceed the warranty period of the defective part. Biomet Sports Medicine shall have no liability or obligation for a product that has been...

  • Page 10: How To Use This Manual

    InnerVue II Diagnostic Scope System ™ Introduction 1.6 How to Use This Manual The intention of this document is to convey the proper and prescribed operation and care of the InnerVue II Diagnostic Scope System. ™ 1.7 Manual Conventions This manual adheres to a set of conventions to help you easily find the information you need and inform you of important information that will help you efficiently and effectively use your equipment.

  • Page 11: List Of Symbols

    Operation and Care Manual Introduction 1.8 List of Symbols (used in this manual and product labels) Type BF Hazard Warning. Applied Part Not Protected Against the Attention: Read Operat- Ingress of Water ing Manual for Warnings, Cautions, Precautions, and Instructions for Use. Caution—...
  • Page 12 Operation and Care Manual CF Card Reader Check to see that you have all of these components before proceeding. If any of these components are missing, contact Biomet Sports Medicine immediately using the contact information below: Biomet Sports Medicine 56 E. Bell Drive Warsaw, IN 46582 Phone: 800.348.9500...

  • Page 13: Product Specifications

    Operation and Care Manual Product Specifications 2.2 Features and Specifications 2.2.1 InnerVue II Diagnostic Scope System Features ™ CompactFlash Media Slot ® KEYPAD Integrated Mode LCD Monitor Delete Microphone Left Select PS2 Keyboard Right Select Connection Store/Enter USB Connection Power Indicator Power Button Speaker Ventilation...
  • Page 14 InnerVue II Diagnostic Scope System ™ Specifications Handpiece Camera POD Camera Handpiece Camera Connector Fiber-optic cable Focus Knob Scope Image Capture Coupler Button Scope Cannula Sliding Sleeve Coupler Luer Fitting/Cannula Scope Scope Probe/Cannula Scope Handle...

  • Page 15: Technical Specifications

    Operation and Care Manual Specifications 2.2.2 Technical Specifications Electrical Input voltage: 120/230VAC, 50/60Hz Input current: 3.0/1.5A maximum. Power connector: IEC 320 Classification: IEC60601-1 Class I, Type BF equipment Mode of operation: Continuous Fuse: 3.15A 250V Type F Environmental Operating altitude: -304.8 to 3657.6m(-1000 to 12000 ft) MSL.
  • Page 16 InnerVue II Diagnostic Scope System ™ Specifications • When used in the presence of other energized, endoscopically-used devices and accessories, such as Lasers and High Frequency Surgical equipment, the safety precautions for such equipment must also be followed. • Before each use, check the outer surface of the arthroscope and arthroscopic accessories to ensure there are no unintended rough surfaces, sharp edges, or protrusions that may cause a safety hazard to the patient or user;...
  • Page 17 • Do not immerse any of the components in liquids. • Do not operate in wet or damp conditions. • If any maintenance or repair is needed beyond superficial cleaning or replacing fuses, contact Biomet Sports Medicine or your authorized service representative. Always unplug the power cord if: •...
  • Page 18 InnerVue II Diagnostic Scope System ™ Specifications WARNING: Possible explosion if used in the presence of FLAMMABLE ANESTHETICS or other EXPLOSIVE GAS MIXTURES. WARNING: This device is not intended to be used in the presence of HIGH FREQUENCY SURGICAL EQUIPMENT. WARNING: This device is not intended to be used in the presence of LASER EQUIPMENT.
  • Page 19 Operation and Care Manual Specifications “Additional equipment connected to medical electrical equipment must comply with the respective IEC or ISO standards (e.g. IEC 60950 for data processing equipment). Furthermore, all configurations shall comply with the requirements for medical electrical systems (see IEC 60601-1-1 or clause 16 of the 3Ed. of IEC 60601-1, respectively). Anybody connecting additional equipment to medical electrical equipment configures a medical system and is therefore responsible that the system complies with the requirements for medical electrical systems.
  • Page 20 InnerVue II Diagnostic Scope System ™ Setup and Basic Usage The following section describes how to set up and use the InnerVue II Diagnostic ™ Scope System for surgical procedures. 3.1 Setup Proper initial setup is essential to provide you and your staff the best access to operational and visual performance while conducting procedures.

  • Page 21: Setup And Basic Usage

    Operation and Care Manual Setup and Basic Usage Pull Sliding Sleeve Drape (Sectioned for illustration purposes) Connect the scope to the camera by pulling the sliding sleeve and inserting the scope. Ensure that the light port is aligned with the bottom of the handpiece and the green dot on the back of the scope lines up with the coupler bump.

  • Page 22: Innervue Ii Diagnostic Scope System

    InnerVue II Diagnostic Scope System ™ Setup and Basic Usage In some cases, you may need a larger display than what it provided by the InnerVue II Integrated Video Display. For this reason, the InnerVue II unit has ™ ™ connections for multiple video outputs.
  • Page 23 Operation and Care Manual Setup and Basic Usage The InnerVue II Diagnostic Scope System can also be connected to a standard VCR or ™ DVR Recorder. Consult your VCR or DVR manual for the corresponding connections. BNC to RCA Adapter (included) S-Video Cable RCS Cable...

  • Page 24: Attaching Virtual Reality Glasses

    InnerVue II Diagnostic Scope System ™ Setup and Basic Usage 3.1.4 Attaching Virtual Reality Glasses 1. To attach the iWear VR glasses, simply take the connector on the end of the glasses and find the 4-pin connector on the back of the InnerVue II Diagnostic ™...
  • Page 25 Operation and Care Manual Setup and Basic Usage Note: If you have audio tag recording enabled, you can also include audio with any still or video images you capture. Refer to the Setup section for more information on audio tag recording. Note: The InnerVue II system will beep every time you press a button on the ™...
  • Page 26 InnerVue II Diagnostic Scope System ™ Setup and Basic Usage 3.1.5.2 Accessories & Attachments You can also connect different accessories to your InnerVue™ II Diagnostic Scope System: Note: Refer to Section 2.2.1 for the location of connectors. If you have audio tag recording enabled with your image captures, audio can be played back and heard from the InnerVue II unit’s speaker.
  • Page 27 Operation and Care Manual Setup and Basic Usage 3.1.5.4 Entering Name and ID Stamping If a Name & ID have already been entered for this card, they will appear on the InnerVue II display. ™ If you want to add or edit the Name & ID for this card, press the Esc key on your keyboard (you will need to attach a keyboard to the InnerVue II system, as ™...
  • Page 28 InnerVue II Diagnostic Scope System ™ Setup and Basic Usage 3.1.5.5a Still Capture Mode Activate the capture for about one (1) second. The light above the Store/Enter button will blink once and the system will beep. The image that appears on the InnerVue II display at the time you press this button is the image that will be ™...
  • Page 29 Operation and Care Manual Setup and Basic Usage 3.1.5.5c Reviewing Images To switch from capturing images to reviewing them, press the Mode button (or F5 key) until you are in Review Mode. A thumbnail gallery of the four (4) most recent images you captured will appear on the InnerVue II display with STILL, VIDEO, or ™...
  • Page 30 InnerVue II Diagnostic Scope System ™ Setup and Basic Usage 3.1.5.6 Setup To enter Setup Mode for the MediaCaptureUSB feature, hold down both the < Select and Select > buttons under the InnerVue II display (or press the F10 key ™...
  • Page 31 Operation and Care Manual Setup and Basic Usage Set Clock Time & Date The current setting for the Date (in MM-DD-YYYY format) and Time (in 24-hour HH:MM:SS format). Note also the following “additional buttons” displayed at the bottom of the The InnerVue II Diagnostic display (and the way they correspond to ™...
  • Page 32 Setup menu. Lamp Counter Notification This is a password-protected factory setting that can only be accessed by Biomet Sports Medicine authorized personnel. Press the Store/Enter button (F9 key) to exit and return to the Setup menu.

  • Page 33: Basic Usage

    Operation and Care Manual Setup and Basic Usage Video Playback Mode This option can help reduce the amount of “jitter” that occurs in some video-image captures. The following choices are available: Dual Field Video Playback Single Field Video Playback If you are experiencing “jitter” in your video-image while playing back video, simply switch to the other playback mode.

  • Page 34: Setup For Each Procedure

    InnerVue II Diagnostic Scope System ™ Setup and Basic Usage 3.2.1 Setup for Each Procedure Ensure that the voltage selector, located on the bottom of the unit, is in the correct position for the line voltage in your area. The switch has two positions: 115V and 230V.
  • Page 35 Operation and Care Manual Setup and Basic Usage System Power Switch Turn on the InnerVue II unit by pressing the Power button (just below ™ the Integrated Video Display). The lamp will start operating immediately. Approximately fifteen (15) seconds later, MediaCaptureUSB will display the time & date, “Still Capture Mode”...

  • Page 36: Power Down Procedures

    InnerVue II Diagnostic Scope System ™ Setup and Basic Usage Connect the combination connector to the matching connector on the front of the InnerVue™ II Diagnostic unit. Note: These instructions are for basic usage of the InnerVue™ II system. Refer to section 1.2 for the “Indication for Use”...

  • Page 37: Cleaning And Maintenance

    ™ EC Waste Electrical and Electronic Equipment (WEEE), or send the equipment to Biomet Sports Medicine for proper disposal free of charge. For the disposal of the single use endoscope, accessories, and procedure kit follow the procedures for the disposal of bio-hazardous materials.

  • Page 38: Fuse Replacement

    InnerVue II Diagnostic Scope System ™ Cleaning and Maintenance 4.5 Fuse Replacement 1. Unplug the InnerVue II power ™ cord from the wall outlet to ensure that no electrical power is present. 2. Use a standard screwdriver to pry the fuse holder free from the back of the unit as shown.

  • Page 39: Troubleshooting

    3. Ensure the scope and handpiece are properly aligned. 4. If your lamp is good or is newly replaced, and light output is now still low, the light fibers in the camera cable may be damaged. Please contact Biomet Sports Medicine for service.
  • Page 40 Authorized Representative in EC All trademarks herein are the property of Biomet, Inc. or its subsidiaries unless otherwise indicated. This material is intended for the sole use and benefit of the Biomet sales force and physicians. InnerVue II Diagnostic Scope System is manufactured by ™...

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