LABORIE PrimeSight UNITY UVP-9000, User Manual

Page 1: ...PrimeSight UNITY DIGITAL VIDEO PROCESSOR User Manual UVP 9000 ...

Page 2: ...ned herein is the exclusive and confidential property of LABORIE No part of this manual may be disclosed or reproduced in whole or in part without permission from LABORIE NOTE Federal USA law restricts this device to sale by or on the order of a physician or other appropriately licensed medical professional ...

Page 3: ...t will be used in conjunction with the Video Processor If you are a first time user LABORIE strongly recommends that you read this manual from beginning to end and become intimately familiar with the Video Processor and its use If you are an experienced user select specific chapters and or sections that pertain to the features that you are using ORGANIZATION OF THIS MANUAL Following is a list and ...

Page 4: ...in a procedure Chapter 7 Maintenance and Storage Describes steps to take in order to clean and disinfect the Video Processor after a procedure is performed There are also instructions on fuse replacement and proper storage environments to employ when the Video Processor is not going to be used for a prolonged period of time Chapter 8 Troubleshooting Describes possible problems that could arise dur...

Page 5: ... 8 During Use 7 3 0 EQUIPMENT OVERVIEW AND PREPARATION 8 3 1 The PrimeSight UNITY 9000 Video Processor 8 3 2 Model and Features 8 3 3 Inspect the Standard Set 10 3 4 UVP 9000 Front Panel and Functions 11 3 5 UVP 9000 Rear Panel and Functions 12 3 6 LCD Monitor 14 3 7 Compatible Videoscopes and Cameras 15 3 8 Accessories 16 3 9 Select an Installation Site 16 3 10 Connect the Videoscope to the Video...

Page 6: ...enu 42 7 0 MAINTENANCE AND STORAGE 45 7 1 After Use 45 7 2 Routine Periodic Inspection 46 7 3 Surface Cleaning and Disinfection 46 7 4 Maintenance and Repair 47 7 5 Replacing the Fuses 48 7 6 Storage 49 7 7 Disposal 49 8 0 TROUBLESHOOTING 50 8 1 Image Issues 50 8 2 UVP 9000 Error Messages 53 8 3 Endoscope Issues 53 9 0 WARRANTY AND SERVICE 54 9 1 Warranty Information 54 9 2 LABORIE Service Informa...

Page 7: ...ay 20 Figure 4 B Monitor Display On Screen Messages and Indicators During Imaging 21 Figure 4 C Patient Day List 26 Figure 4 D Patient Directory Screen 27 Figure 4 E Patient Information Entry Screen 28 Figure 4 F User Login Input Pop up 30 Figure 4 G Archive Screen for Current Patient 31 Figure 4 H Video Review Screen 32 Figure 4 I Main Setup Menu 33 Figure 4 J User Configuration Tab 34 Figure 4 K...

Page 8: ...u 34 Table 4 3 5 B Backup and Restore Functions 36 Table 4 3 5 C Security Functions 37 Table 6 2 Enhance Pop up Menu 42 Table A 2 1 Electromagnetic Emissions Declaration 57 Table A 2 2 Electromagnetic Immunity Declaration 58 Table A 2 3 Electromagnetic Immunity Declaration 59 Table A 2 4 Recommended Separation Distances 60 Table A 2 5 Test Specifications for Enclosure Port Immunity to RF Wireless ...

Page 9: ...afety degree specified by IEC 6061 1 for protection against electrical shock Consult Instructions for Use 5 4 3 1 Indicates the need for the user to consult the instructions for use prior to operating the device Follow instructions for use Table D 2 Symbol 10 4 Instructs users of Medical Electrical equipment to follow the instructions for important device safety information Catalogue Number 5 1 6 ...

Page 10: ...ally compliant with all applicable European Union EU regulations and recommendations For Prescription Only Indicates this device is restricted to sale by or on the order of a physician 5013356 MEE Medical Electrical Equipment Mark The presence of this safety mark shows that the device is Medical Electrical Equipment which has been evaluated with respect to electrical shock fire and mechanical haza...

Page 11: ... are used throughout this User Manual Processor Video Processor Equipment or Unit refers to the PrimeSight UNITY 9000 Video Processor System or Endoscopic System refers to a Video Processor with an endoscope connected to it UNITY 9000 refers in a general manner to the UVP 9000 Digital Video Processor model ...

Page 12: ...E MODEL NUMBER ENDOSCOPY SYSTEM INDICATION Cystoscope CST 5000 CST 5000i For the display and management of video and images during endoscopic examination of the lower urinary tract including the bladder Trans nasal esophagoscope TNE 5000 For the display and management of video and images during endoscopic examination of the larynx esophagus and gastro esophageal junction Bronchoscope BRS 5100 For ...

Page 13: ...sed in a procedure The Processor may only be serviced or repaired at an authorized LABORIE facility In addition to thoroughly inspecting the Processor before each procedure periodic inspections should be performed to determine if there is wear or damage that requires attention Refer to Chapter 7 Maintenance and Storage for procedures on maintaining the PrimeSight UNITY 9000 Video Processor Refer t...

Page 14: ...in fire or explosion In areas where it could become wet or exposed to conditions such as high temperature humidity direct sunlight dust salt etc In areas where it could be subjected to impacts or vibrations In areas where the processor s air intake vent is obstructed or blocked Do not allow the power cord to become twisted crushed or pulled taut This could cause the cord to become damaged Only pos...

Page 15: ...rds To prevent electrical shock the endoscope and or any other ancillary device s connected to the unit should never be applied directly to the heart If the operation of any component of the endoscopic system fails during the procedure or if the endoscopic image is lost or compromised place the endoscope s distal bending section in the neutral position and slowly withdraw it from the patient Conti...

Page 16: ... from the on screen keyboard and icons Functions can either be set before procedures or changed during them Pre programming specific Processor functions into the Control Buttons of a connected endoscope enables users to capture and print images or activate other functions without disrupting procedures 3 2 MODEL AND FEATURES The UVP 9000 model is equipped with an integrated 19 inch display folds do...

Page 17: ...rage for patient data and image video capture and management Additional USB ports for external keyboard USB storage backup and printers Freeze function with live picture in picture window Processor functions that are operable from Videoscope control buttons Touchscreen icon controls External Internal keyboard Dual foot pedal optional Automatic exposure control for shutter speed and illumination On...

Page 18: ...ard with Trackpad USB 14513 PrimeSight UNITY 9000 Series User Manual this document Optional items and accessories not shipped with Video Processor 07 5033 Fuses 4A DPU Series Replacement 07 5010 DCH 5000 NTSC Digital Camera Head includes Camera Head Lens and Coupler 07 9013 Dual Foot Pedal USB interface 2 0m cable 07 5022 Cable USB A to USB B Printer 2 0m 07 9016 Cable Digital Display DisplayPort ...

Page 19: ... Figure 3 A shows the front view of the PrimeSight UNITY UVP 9000 Video Processor This section describes the functions of the buttons and switches on the front panel Figure 3 A UVP 9000 Front View 1 Videoscope Connector For connecting the Videoscope Cable 2 Standby Switch Press to turn the Video Processor on or off standby mode 2 1 ...

Page 20: ...ibed in this section Figures 3 B and 3 C show the rear panel of the PrimeSight UNITY 9000 Video Processor Figure 3 B UVP 9000 Rear Panel Left Side LAN For connecting to an Ethernet local area network Identification Tag Identifies LABORIE contact information the unit s catalog number and unique serial number and compliance symbols Remote 1 and Remote 2 Feature not supported ...

Page 21: ...SB devices USB connections may be used to connect to external keyboard USB printer foot pedal external storage such as USB memory stick or hard drive or to power analog speakers with USB power connector Optional USB Type A B cable is available Cat 07 5022 Equipotential Stud Safety grounding connection for medical facilities requiring equipotential grounding of electrical instruments AC Power Power...

Page 22: ...or displays the endoscopic image on the Processor s integrated flip up LCD monitor see Figure 3 D Figure 3 D Flip Up LCD Monitor on UVP 9000 The monitor screen displays information in designated areas These include Endoscopic Image Date and Time Patient Information Touchscreen icons for controlling the system On Screen Note Function Pop up Messages ...

Page 23: ...re 3 E Programming the buttons is done using the User Configuration Tab in the Setup Menu covered in Chapter 4 User Interface Figure 3 E Videoscope Control Buttons The available functions that can be programmed to these control buttons are Disabled not assigned Image Capture Video Capture Print Brightness Sharpness Orientation Zoom Text On Off Freeze Auto White Balance Exposure Mode NOTE In order ...

Page 24: ...s any defects Continued use of such a unit may impair its long term operability and could cause patient and or operator injury To prevent electric shock connect the power cords of any non medical grade peripheral equipment through medical isolation transformers Confirm that all other devices used in conjunction with the PrimeSight UNITY 9000 Video Processor are compatible with the Video Processor ...

Page 25: ...ideo Processor with the orientation arrow facing up The connector which will be used is signified by the endoscope symbol located to the right as shown in Figure 3 F Gently push the cable plug into the Video Processor s front panel connector until it stops This is designed to be a very snug fit Figure 3 F Connect the Videoscope Cable to the Video Processor 3 11 CONNECT PERIPHERAL EQUIPMENT The UNI...

Page 26: ...roduct contact your local LABORIE distributor Figure 3 H AC Power Cable Connectors Make sure that the main power switch to the unit is off before connecting the power cable To connect the power cable to the PrimeSight UNITY 9000 Video Processor Connect the supplied power cable into the three prong inlet on the rear panel of the PrimeSight UNITY 9000 Video Processor Plug the other end into an AC wa...

Page 27: ...operly including all switches indicators etc 3 15 TURN ON THE VIDEO PROCESSOR After the system has been fully assembled and all connections made as described above power on the PrimeSight UNITY 9000 Video Processor by setting the main power switch on the rear of the unit to ON and then pressing the Standby Switch on the front panel The blue indicator in the Standby Switch will blink indicating tha...

Page 28: ...tem control icons Right Side Icon Panel Shortcut and function icons Image Window Procedural video images or saved still images or videos occupy the center of the screen Pop up screens are also displayed in the Image Window area Programmable Button Display Below the User icon the assigned functions for programmable endoscope buttons and foot pedals are displayed Figure 4 A Main Display ...

Page 29: ...ayed in the Message Area in the lower right corner of the image area Figure 4 B These messages could include White balance in process White balance OK White balance failed Image captured Start video capture Stop video capture Printing image Figure 4 B Monitor Display On Screen Messages and Indicators During Imaging ...

Page 30: ...ns will display in one of three different states Function Not Available Medium Blue on Light Blue Background Function is Available White on Light Blue Background Function is Selected Dark blue on White Background MAIN SYSTEM CONTROLS USER Displays User window PATIENT Displays Patient window SCOPE OFF Turns off scope Scope may be disconnected when the system indicates that scope is powered off If s...

Page 31: ...m the white target After white balance is finished displays message White Balance OK if successful or White Balance Failed IMAGE CAPTURE Saves current frame of live image or video playback to disk or sends image to EMR system if EMR option is configured VIDEO CAPTURE Starts capturing live image to disk Video recording is limited to a maximum duration of 10 minutes after which recording will automa...

Page 32: ... then wraps around back to Zoom of 1 0 ORIENT Inverts the image Press again to restore to normal orientation BRIGHTNESS Adjusts Brightness setting in increments of 10 After maximum brightness is reached 100 wraps around to minimum setting 0 EXPOSURE Cycles through exposure modes of Auto Peak and Average SHARPNESS Cycles through Sharpness settings Low Medium High TEXT OFF Removes display of all on ...

Page 33: ...ctive image video from among selected images videos FAST Only available when viewing a video clip When video is playing increases video playback speed each tap doubles the playback speed x1 x2 and x4 then wraps around to x1 When paused steps single frame forward if held down then continuously steps one frame forward until released PREVIOUS Move to previous image video for the patient Previous imag...

Page 34: ...tory branching from the main Patient screen are listed and described in this section Figure 4 C Patient Day List Patient Day List The Video Processor s Patient Day List sub menu options are described in Table 4 3 1 below FUNCTION OPTIONS Start Procedure End Procedure Selects the highlighted patient from the Day List for a new procedure or ends the procedure for the current patient and clears the i...

Page 35: ...lected patient to the Day List Create Patient Opens the Create Patient screen to input a new patient automatically added to the archive Edit Patient Opens the patient entry screen to allow editing of the selected patient information Archives Opens the Archives screen to view saved images and video clips for the selected patient Refresh Updates the Patient Directory to display any newly added patie...

Page 36: ... information in the fields provided Patient ID Gender and DOB are mandatory fields for which information must be entered Patient ID Enter up to 15 alphanumeric characters as a unique identifier for the patient NOTE Be careful when entering the patient ID this cannot be changed in Edit Patient mode after it is created for the patient Patient ID is a mandatory field First Name Enter up to 20 alpha c...

Page 37: ...ftware where Gender and DOB were not required fields if DOB was not entered it will be assigned a default value of January 1 1900 and if Gender was not specified it will be assigned a default value of Other These default values may be corrected using the Edit Patient screen Patient Data Management The Edit Patient function opens the patient detail screen to edit the current patient information The...

Page 38: ...ure to maintain secure access to the system when not in use Figure 4 F User Login Input Pop up For details regarding configuring the system for a user consult the User Configuration section under the Setup icon section For details regarding the creation and maintenance of user accounts on the system consult the Manage Users section under the Setup icon section 4 3 3 Scope Off The third screen icon...

Page 39: ...bnail for either review or exporting to external storage Buttons a Review Selected display the still image or video clip that is selected If a video clip is selected playback will immediately start Figure 4 H If multiple images have been selected then they are shown side by side for two images and a 3 x 2 format if from 3 to 6 images were selected Selecting any one of the previews in this subset m...

Page 40: ...The PrimeSight UNITY 9000 Video Processor User Manual 4 User Interface 32 Video Review Screen Figure 4 H Video Review Screen ...

Page 41: ...ed in user The remaining four tabs are accessible only to users with system administrator privileges After changing a setting on the Setup screen press the SAVE button to store the changes before switching to another tab or exiting the Setup screen Setup Tab The Setup tab allows the user to configure among other options the display of on screen text and notes select the language for the user inter...

Page 42: ...inter Select default printer from the drop down list of supported printers Still Image Format Select the format for saving of still images JPEG or TIFF format File Export Format Select format for exporting image and video files in native or DICOM format On Screen Keyboard Enable disable use of the on screen keyboard Set Date Time Modify date time setting or enable automatic time setting if connect...

Page 43: ...Manual 35 4 User Interface Manage Users Tab The Manage Users tab Figure 4 K allows a system administrator to create new user accounts edit existing user accounts Figure 4 L and deactivate users Figure 4 K Manage Users Tab Figure 4 L Edit User Screen ...

Page 44: ...y selects on which day of the week to run the backup Backup Start Time Time of day to run backup Archive Records Remove files older than specified interval Patient Export Location Select network directory location or external device for exporting captured patient images or video from Archive Backup Now Start a backup immediately Restore Database Restore the database of all patients and users from ...

Page 45: ...testing for passwords on off Minimum Password Length Select minimum number of characters for password Require Non Alphanumeric Require password to contain a non alphanumeric character such as or Require a Number Require password to contain a number Require an Uppercase Require password to contain an uppercase character Password Expiration Select interval for expiration of a password and require a ...

Page 46: ...xport the selected daily log file for cybersecurity auditing Figure 4 O Audit Logs 4 3 6 Help Screen The sixth and final screen icon is Help The Help screen will display a listing of available help topics and video clips available on the system Figure 4 P Select the desired topic and then press Review Selected Figure 4 P Help Screen ...

Page 47: ...p of the live endoscopic image various elements can appear On Screen Display OSD Notes Status Messages etc Frozen Image When the user freezes an image by default the frozen snapshot image will be shown in the main image windows and an inset view in the upper right will continue to show the live video image Archiving mode will display in the main image window once a stored image video file is retri...

Page 48: ...inter which is non medical grade in order to prevent the risk of electric shock 5 5 BACKUP IMAGES AND DATA Patient folders with still images and video recordings saved in internal storage may be archived to a USB storage device connected to the UNITY 9000 or a network folder location on the local area network It is strongly recommended to routinely backup patient data to an external USB storage de...

Page 49: ... operating the system for the first time If lighting conditions change If a different Videoscope is used If colors seem to differ from true colors To White Balance Point the distal end of the endoscope at a white object such as a white cloth or sheet of paper Hold the endoscope tip approximately one inch 3cm from the white target and keep it steady during the White Balance procedure Note Make sure...

Page 50: ... 6 A are described in Table 6 2 FUNCTION OPTIONS Brightness Adjust the image brightness level 0 through 100 Color Intensity Adjust color intensity range 0 to 100 Zoom Zoom in on the image up to twice the original size select from 1 0 through 2 0 zoom range 1 0X to 2 0X in steps of 0 1 System can show or hide zoom level indication when zoom is at level 1 no indication is shown regardless of setting...

Page 51: ...es in steps of 0 1 at any time during use By default when the Zoom level is at a value other than 1 0 the screen will display the Zoom level When the Zoom level is higher than 1 0 the magnified image may be panned using the panning controls at the edges of the screen 6 2 4 Exposure Mode This function allows the user to change the basis on which the automatic exposure is adjusted It represents the ...

Page 52: ...eld or to orient the view of the anatomy The two orientation selections are Normal Flipped 6 2 7 Enhance Window Buttons The Enhance window has three buttons to control the saving or restoration of settings BUTTON FUNCTION Reset to Factory Reset the current user s Enhance settings to the factory default values Reset to User Reset the current user s Enhance settings to the last saved settings and ov...

Page 53: ...e equipment damage Do not attempt to open or modify the Video Processor Doing so can present a risk of shock to the user or patient The Video Processor may only be serviced at authorized LABORIE facilities When the procedure is complete the endoscopic system must be disconnected and its components reprocessed Since the Video Processor normally does not come in contact with patients and due to its ...

Page 54: ...rted or moved between locations 7 3 SURFACE CLEANING AND DISINFECTION Failure to properly clean the surface of the Video Processor may impair effective surface disinfection Do not allow liquids or excessive moisture to get on or into the Video Processor This could cause equipment damage Do not use cleaning disinfecting agents that are not permitted for use with plastics such as ammonia acetone or ...

Page 55: ... Video Processor with a surface disinfectant that is compatible with electronic equipment Do not allow fluids to get into electrical connectors Allow the Video Processor to remain exposed to the disinfectant for the period of time recommended by the disinfectant manufacturer Carefully wipe the Video Processor with 70 isopropyl alcohol then wipe all outside surfaces of Video Processor with soft dry...

Page 56: ...hat the main power switch on the rear panel is in the OFF position 2 Disconnect the power cord from the processor 3 The Fuse Module is located in the center of the power entry module 4 Extract the fuse module using a screwdriver 5 Replace only with identical type fuses Type T4AH Slow Blow High Breaking Capacity 4A 250V 6 Remove the two old fuses and insert two new fuses into the appropriate clips ...

Page 57: ...hould never be stored in the presence of flammable or explosive gases or chemicals This equipment should never be stored or transported in an inclined position nor should it be subjected to impact or vibration Cords accessories etc should be wiped clean and neatly stored This equipment should be maintained in a clean condition during storage to be ready for subsequent use Do not stack or place ite...

Page 58: ...ues related to image problems you may also have to refer to the Troubleshooting Chapter in the User Manual of the endoscope that is connected to the Video Processor 8 1 IMAGE ISSUES PROBLEM POSSIBLE CAUSE SUGGESTED ACTION No Image Processor power is not on Turn rear Processor power switch on Check power cord connection and fuses or connect the Processor to a different wall outlet External monitor ...

Page 59: ...ue There may be a problem with the connection from the processor to the integrated LCD monitor Return the Processor to LABORIE for repair Image colors are not accurate Settings on the external LCD monitor are not correct including Brightness and Contrast Reset the external LCD monitor settings back to the factory default settings Endoscope has not been properly white balanced Perform another Auto ...

Page 60: ...ssible Cables running from the Processor to monitor are damaged or improperly connected Inspect cables to ensure they are not damaged and are properly connected Cable may need to be replaced or use an alternate video output from Processor Endoscope is damaged Send the endoscope and Processor to LABORIE for repair Patient debris or other material on the Objective Lens Clean the Distal Tip with an a...

Page 61: ...not connected properly to the Processor Reinsert the endoscope plug into the Processor Turn off processor and re start Scope sensor or electronics may be damaged Return the endoscope to LABORIE for repair Buttons are not responding Endoscope button is stuck Check the buttons they should move freely Endoscope plug is not completely inserted into the Processor Reconnect endoscope to the Processor En...

Page 62: ...f the invoice All non warranty repairs will be warranted to be free from defects in materials and workmanship for a period of ninety 90 days from the date of the invoice Upon receipt of the PrimeSight UNITY 9000 Video Processor for repair LABORIE will evaluate the equipment and make the final decision as to the warranty status The above warranties are in lieu of all other warranties either express...

Page 63: ...nated in accordance with OSHA standards 29 CFR 1910 1030 Observe the following precautions before shipping the Video Processor The Video Processor or any other LABORIE equipment must be shipped in the original box with the original protective foam caps to prevent damage during shipment If the original packaging is not available at the time of shipping contact your regional distributor or LABORIE C...

Page 64: ... IEC 60601 1 2012 Edition 3 1 EN 60601 1 2006 A1 2013 A12 2014 CSA CAN CSA C22 2 No 60601 1 14 Medical Electrical Equipment Part 1 General Requirements for Basic Safety and Essential Performance including National Differences for Canada IEC 60601 1 2 2014 IEC 60601 1 6 2010 Third Edition A1 2013 IEC 60601 2 18 2009 Degree of Protection Against Electric Shock Type BF Body Floating Equipment Class C...

Page 65: ...user of the System should assure that it is always used in such environments Emissions Test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The System uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class A The System is suitable for ...

Page 66: ...utput lines Main power quality should be that of a standard commercial or hospital environment Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Main power quality should be that of a standard commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 95 dip UT for 0 5 cycle...

Page 67: ...mended separation distance in meters m Field strengths from fixed RF transmitter as determined by an electromagnetic Sight surveya 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 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situatio...

Page 68: ...ransmitter P W Separation distance according to frequency of transmitter d m 150 KHz to 80 MHz d 3 5 V1 P 80 MHz to 800 MHz d 3 5 E1 P 800 MHz to 2 5 GHz d 7 E1 P 0 01 d 0 12 d 0 12 d 0 23 1 d 0 37 d 0 37 d 0 74 1 d 1 17 d 1 17 d 2 33 10 d 3 69 d 3 69 d 7 38 100 d 11 67 d 11 67 d 23 33 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters...

Page 69: ...45 780 704 787 LTE Band 13 17 Pulse modulationb 217 Hz 0 2 0 3 9 810 870 930 800 960 GSM 800 900 TETRA 800 iDEN 820 CDMA 850 LTE Band 5 Pulse modulationb 18 Hz 2 0 3 28 1 720 1 845 1 970 1 700 1 990 GSM 1800 CDMA 1900 GSM 1900 DECT LTE Band 1 3 4 25 UMTS Pulse modulationb 217 Hz 2 0 3 28 2 450 2 400 2 570 Bluetooth WLAN 802 11 b g n RFID 2450 LTE Band 7 Pulse modulationb 217 Hz 2 0 3 28 5 240 5 50...

Page 70: ...cense Json Net Newtonsoft Open source under MIT license NLog Nlog project org Kim Christensen Julian Verdurman Open source BSD 3 Clause license Reactive Extensions Net Foundation and Contributors Creative Commons Attribution 3 0 License FFmpeg www ffmpeg org licensed under the GNU Lesser General Public License LGPL version 2 1 or later FreeRTOS TCP www freertos org Open source under MIT license ...

Page 71: ......

Page 72: ... NY 10962 USA www laborie com For additional product information or questions pertaining to sales and service please contact the local distributor or the manufacturer www laborie com 2018 2019 2020 LABORIE EndoSheath is a registered trademark and PrimeSight is a trademark of LABORIE 05 20 14513 EN Rev D 04620 ...