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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.

Operating temperature:

0ºC to 40ºC (-32ºF to 104ºF).

Operating humidity:

0% to 95% RH, non-condensing.

Storage/transport altitude:

-304.8 to 10668m (-1000 to 35000 ft) MSL.

Storage/transport temperature: 0ºC to 50ºC (-32ºF to 122ºF).

Storage/transport humidity:

0% to 95% RH, non-condensing.

Video / Display

Input video format:

NTSC Composite, 75Ω, 1Vp-p.

Video output 1:

NTSC Composite, 75Ω, BNC.

Video output 2:

NTSC Y/C, 75Ω, 4-pin circular DIN.

Video output 3:

NTSC Composite, 75Ω, 4-pin VR glasses

connector.

Display type:

LCD 16.25 cm (6.4 in) TFT,

active matrix (960Hx 234V)

Light Source

Type:

Xenon Arc

Lamp:

BL35WXe

Power:

35W

MediaCaptureUSB

Storage media:

CompactFlash® Ultra II 15m/s or greater

Still image file format:

JPEG

Still image size:

640x480 pixels.

Video file format:

AVI (MJPEG codec)

Video size/fram rate:

640 x 480 pixels/15fps.

Compatible Camera Attachments

Needlescope:

922142 100 – 100mm

922180 10˚ 65mm

2.3 Safety Information

General requirements for the safe use of the device:

• It is important that you read, understand, and comply with all of the following

safety precautions, markings, labeling, and all accompanying literature.

• Failure to follow these precautions could result in injury to the patient or user,

or damage to the InnerVue

™

II unit.

Содержание innerVue II

Страница 1: ...Operation and Care Manual ...

Страница 2: ...uses only This manual describes the recommended procedures for preparing and operating the InnerVue II Diagnostic Scope System It does not describe how any medical procedure is to be performed on a patient with this instrument Read all instructions in this manual carefully before using the InnerVue II Diagnostic Scope System Carefully follow all safety instructions to prevent injury to the user or...

Страница 3: ... Information 3 0 Setup and Basic Usage 3 1 Setup 3 1 1 InnerVue II Diagnostic Scope System 3 1 2 Attaching a Camera System and Endoscope s 3 1 3 Attaching External Video Devices 3 1 4 Attaching Virtual Reality Glasses 3 1 5 Setting Up and Operating MediaCaptureUSB 3 2 Basic Usage 3 2 1 Setup for Each Procedure 3 2 2 Power Down Procedures 3 2 3 Single Use Endoscope Disposal 4 0 Cleaning and Mainten...

Страница 4: ...d Video Display with Multiple Outputs The high resolution 6 4 LCD monitor combines the performance of the Xenon Fiber Optic Light Source and High Resolution Camera System to deliver a brilliant high resolution video image for clear detail recognition and outstanding color reproduction Multiple Output options on the InnerVue II Diagnostic Scope System unit allow you to connect larger external video...

Страница 5: ...irective 93 42 EEC Federal law restricts this device to sale by or on order of a physician licensed by the law of the state in which he practices to use or order the use of this device 1 4 1 Electromagnetic Compatibility IEC 60601 1 2 Guidance and Manufacturer s Declaration Electromagnetic Emissions The InnerVue II Diagnostic Scope System is intended for use in electromagnetic environment specifie...

Страница 6: ... lines Mains power quality should be that of a typical commercial or hospital environment Voltage Dips short interrup tions and voltage variations on power supply in put lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 sec 100 dip for 0 5 cycles 60 dip for 5 cycles 30 dip for 25 cycles 100 dip for 5 second...

Страница 7: ...on distance in meters m Field strengths from fixed RF transmitters as determined by and electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At 80MHz and 800MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagne...

Страница 8: ...ivered to the end user in new condition in the original container the InnerVue 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 Biomet Sports Medicine and are determined by Biomet Sports Medicine...

Страница 9: ...RRANTIES BIOMET SPORTS MEDICINE HEREBY DISCLAIMS AND EXCLUDES ALL OTHER WARRANTIES EXPRESS OR IMPLIED INCLUDING BUT NOT LIMITED TO ANY AND OR ALL IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE BIOMET SPORTS MEDICINE HEREBY DISCLAIMS ANY REPRESENTATIONS OR WARRANTY THAT THIS PRODUCT OR ANY OF ITS PARTS IS COMPATIBLE WITH NON BIOMET SPORTS MEDICINE PRODUCTS OTHER THAN VIDE...

Страница 10: ... that will help you efficiently and effectively use your equipment Sections and sub sections are noted as follows Special and important information is called out using notes and warnings Notes usually pertain to a recommended protocol that will help extend the life of your equipment Warnings pertain to protocols that delineate appropriate actions which maintain a safe and healthy work environment ...

Страница 11: ...ICE TUV Nationally Recognized Testing Laboratory NRTL Mark Federal Communications Commission Mark Date of Manufacturing Attention Read Operat ing Manual for Warnings Cautions Precautions and Instructions for Use Caution High Voltage Caution Hot Not Protected Against the Ingress of Water 1 8 List of Symbols used in this manual and product labels Introduction ...

Страница 12: ...I Diagnostic Scope System Integrated Visualization System Base Unit Medical Grade Power Cord 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 www b...

Страница 13: ...ystem Features Microphone PS2 Keyboard Connection USB Connection Mode Delete Left Select Right Select Store Enter Power Indicator Power Button Speaker Ventilation Exhaust Integrated LCD Monitor CompactFlash Media Slot Camera Connector S Video Ventilation Exhaust VR Connector Composite Video Fuse Holder Power Connector KEYPAD ...

Страница 14: ...stem Handpiece Camera POD Camera Handpiece Camera Connector Scope Coupler Focus Knob Image Capture Button Scope Cannula Sliding Sleeve Scope Probe Cannula Luer Fitting Cannula Coupler Scope Handle Scope Fiber optic cable Specifications ...

Страница 15: ...deo output 1 NTSC Composite 75Ω BNC Video output 2 NTSC Y C 75Ω 4 pin circular DIN Video output 3 NTSC Composite 75Ω 4 pin VR glasses connector Display type LCD 16 25 cm 6 4 in TFT active matrix 960Hx 234V Light Source Type Xenon Arc Lamp BL35WXe Power 35W MediaCaptureUSB Storage media CompactFlash Ultra II 15m s or greater Still image file format JPEG Still image size 640x480 pixels Video file fo...

Страница 16: ...ries All damaged instruments shall be discarded immediately In the event of a loss of system function during a procedure no further visualization is necessary and the procedure is ended the physician shall remove the arthroscope and proceed with closure or further patient care as needed Further arthroscopic examination shall only be performed with a fully functional system for which a backup unit ...

Страница 17: ... cleaning the InnerVue II Diagnostic Scope System replacing fuses etc always perform the following Unplug the power cord Allow unit to cool for at least ten 10 minutes after turning off Do not allow spilling of liquids on the InnerVue II unit 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 o...

Страница 18: ...r the light receiving window of the endoscope They may become hot after long periods of use WARNING Do not touch the light receiving port of the handpiece upon disconnection The tip of the port may become hot after long periods of use WARNING DO NOT IMMERSE the camera handpiece in liquids of any kind personal injury or damage to the device may result To avoid electromagnetic interference Special p...

Страница 19: ...f in doubt consult your local representative or the technical service department Zusätzliche Geräte die an medizinische elektrische Geräte angeschlossen werden müssen nachweisbar ihren entsprechenden IEC oder ISO Normen entsprechen z B IEC 60950 für datenverarbeitende Geräte Weiterhin müssen alle Konfigurationen den normativen Anforderungen für medizinische Systeme entsprechen siehe IEC 60601 1 1 ...

Страница 20: ...he height and display angle 3 1 2 Attaching a Camera Handpiece and Arthroscope The InnerVue II camera handpieces attach via a combination fiberoptic electric connector This connector seats in the receptacle on the front of the unit See also 2 2 1 Front Before connecting a camera handpiece to the InnerVue II unit the camera or handpiece must be properly cleaned Note For best image quality and to en...

Страница 21: ... scope in place The proper technique must be utilized in order to preserve the sterile field through the drape that is attached to each endoscope Turn the power on The monitor will power up within about fifteen 15 seconds Hold the distal tip of the scope approximately 2 0cm from a surface with fine details such as your palm or surgical drape Turn the focus adjustment knob in either direction until...

Страница 22: ...tions plug the connecting cable s into the video output s on the rear of the InnerVue II Diagnostic System and the corresponding video input s of the external devices A BNC to RCA adapter is supplied with the InnerVue II Diagnostic Scope System for use with an RCA cable so that such connections can be made with an RCA cable as well as a BNC cable The adapter allows an RCA cable to be plugged into ...

Страница 23: ...ding connections The InnerVue II Diagnostic Scope Systemcan also be connected to a standard camcorder Consult your camcorder manual for the corresponding connections S Video Cable not included BNC to RCA Adapter included RCS Cable not included BNC Cable not included VCR or DVR Recorder Camcorder S Video Cable not included BNC to RCA Adapter included RCS Cable not included BNC Cable not included ...

Страница 24: ...ble to be activated from the sterile field via the camera connected to the system Your hand never has to leave the camera to capture what you need Note All functions that appear on the InnerVue II display are also mirrored on any external display 3 1 5 1 Modes The MediaCaptureUSB has three separate modes of operation 1 Still Capture Mode for capturing still images pictures 2 Video Capture Mode for...

Страница 25: ...ou 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 MediaCaptureUSB panel just under the InnerVue II display To move between the different modes in the above order press the Mode button under the InnerVue II display or press the F5 key on your keyboard ...

Страница 26: ...rivers that allow Windows 2000 and XP systems to use the InnerVue II system as a video source These drivers will also be available for other software on your system that is aware of such multimedia devices The BioVision ViCAM III Utilities ViCAM III AMCAP software also included with this installation provides a window on your main computer monitor that mirrors the InnerVue II display Note If you h...

Страница 27: ...InnerVue II display Note All of these fields are upper case only The cursor initially sits in the Name field Use your keyboard to enter a Name or edit the current Name 15 characters max Press the Tab key to move to the ID field and enter or edit an ID 10 characters max When you are finished entering this information press the Enter key on your keyboard to accept it and exit this mode 3 1 5 5 Captu...

Страница 28: ...e recording will last and the light above the Store Enter button will remain on for ten 10 seconds If you chose the No Recording Limit option the recording will last and the light above the Store Enter button will remain on until you press the Store Enter button again or up to the file size limit i e the amount of free space remaining on the card or 2 GB total Please refer to the Setup section for...

Страница 29: ...l through image captures while they are being displayed in full press the Select or Select buttons or the F7 or F8 keys respectively To return to the thumbnail gallery displaying four 4 images at a time press the Store Enter button F9 key again To delete the currently highlighted image press the Delete button or the F6 key The following menu will appear Remove Current Record deletes the currently ...

Страница 30: ...ption in greater detail Set Recording Time Limit This option pertains to Video Mode only Press the Select or Select buttons or the F7 or F8 keys respectively to highlight one of the following recording time limit options for video captures and then press the Store Enter button F9 key to select it and return to the Setup menu 10 Second Recording Limit this option provides up to ten 10 seconds of re...

Страница 31: ... F7 button to move to the Day of the Date and make the same adjustments Then do the same with the Year Hour and Minutes adjusting the Minutes will reset the Seconds to 00 When you are finished adjusting the Date and Time press the Done Store Enter F9 button to set them and return to the Setup menu Set Audio Setting This option allows you to add an audio tag to every image or video you capture Pres...

Страница 32: ...ss is complete you will return to the File System Manager screen To cancel this process press the Store Enter button F9 key You will return to the File System Manager screen OSD Overlay Position This option allows you to adjust the vertical positions of the Name ID and Date Time strings that are included with every image you capture Note The Name ID string appears at the top of the display The Dat...

Страница 33: ...n in Dual Mode Button pressing the handpiece button will store a still image if the button is held for two seconds the system will start recording video Pressing the button again stops recording Single Mode Button This mode allows audio to be recorded with still images If Audio Tag Recording is enabled To record a still image with audio press and hold the camera button for two seconds Recording Au...

Страница 34: ...rrect position for the line voltage in your area The switch has two positions 115V and 230V 115V is for U S use 230V is typically for use in Europe System Power Connector Setup and Basic Usage Connect the medical grade power cord to the InnerVue II unit Connect the other end of this cord to a power outlet that has also been approved for medical use ...

Страница 35: ...ower 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 and Patient ID information if available System Power Switch Setup and Basic Usage ...

Страница 36: ...on for Use 3 2 2 Power Down Procedures When you are finished using the InnerVue II system turn off the system in order to conserve lamp life Always disconnect the InnerVue II unit from its power source when performing any kind of maintenance e g cleaning replacing fuses etc 3 2 3 Single use endoscope disposal When disposing of the single use endoscope and endoscope accessories follow procedures fo...

Страница 37: ...t use or store disinfecting fluids above or on the InnerVue II Diagnostic Scope System 4 3 Lamp Life Monitoring and Replacement Each time you turn on the InnerVue II unit the monitor will display the number of hours of lamp life remaining Hours Remaining Display Format Display Interval 51 or more LAMP HOURS REMAINING 5 seconds 26 50 LAMP HOURS REMAINING 10 seconds 6 25 LAMP HOURS REMAINING 20 seco...

Страница 38: ... 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 3 Disengage the fuses as shown Replace with new fuses WARNING USE 3 15A 250V TYPE F FUSES ONLY 4 Place the fuse holder back in the unit Push firmly until it snaps into place Cleaning and Maintenance ...

Страница 39: ...p See 4 3 Lamp Replacement 3 Contact InnerVue II technical support and or service Make a note of the camera you are using If you have multiple camera attachments the support person may ask you to try another camera It may be necessary to send the camera you are using for service along with the InnerVue II unit C The image is blurry 1 If you are using a camera coupler rotate the focus ring to bring...

Страница 40: ...presentative in EC Distributed by 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 It is not to be redistributed duplicated or disclosed without the express written consent of Biomet For product information including indications contraindications warnin...

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