LABORIE PrimeSight UNITY UVP-9000 User manual

PrimeSight™UNITY
DIGITAL VIDEO PROCESSOR
User Manual
UVP-9000

© 2018, 2019, 2020 LABORIE. All rights reserved. Printed in the United States
of America.
The information contained 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.

The PrimeSight UNITY 9000 Video Processor User Manual i
This User Manual contains instructions on the proper use of the LABORIE PrimeSight™ UNITY 9000 Digital
Video Processor, which includes the following model:
• UVP-9000
This manual is intended for physicians and other medical personnel who will come in contact with the Video
Processor before, during, and after any patient procedures in which they are used. All users should read
and become familiar with this entire manual before use.
The manual contains the following information:
• The intended use of the Video Processor and peripheral equipment
• Descriptions of the Video Processor’s features and settings
• Instructions on installation, operation, and proper care and storage of the equipment
• Warning and Caution statements that must be observed to ensure patient and user safety while using
the equipment
The PrimeSight UNITY 9000 Digital Video Processor is designed to work with the LABORIE 5000 Series
Videoscopes. Thoroughly review the User Manual for the endoscope that 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 brief descriptions of the chapters in this manual. The chapter title is listed at
the top of all pages after the title page, so that you can quickly access the information you need.
Chapter 1, Symbols and Terms – This chapter shows and defines the symbols and labels that
appear on or are attached to the Video Processor and peripheral equipment. There is also a brief
list of the common terminology that is used in the manual.
Chapter 2, Important Information – This chapter describes the Video Processor’s intended use and
summarizes the critical warning and caution statements in the manual. This information is essential
to the safe operation of the Video Processor. LABORIE strongly recommends that this chapter be
read thoroughly and completely understood by all users before working with the processor.
HOW TO USE THIS MANUAL

The PrimeSight UNITY 9000 Video Processor User Manualii
How To Use This Manual
Chapter 3, Equipment Overview and Preparation – Introduces the PrimeSight UNITY 9000 Digital
Video Processor and compatible peripheral equipment. This chapter includes instructions on
the proper assembly of all equipment, instrument diagrams, identifies system components, and
defines their functions. The chapter also details a thorough inspection procedure to confirm that all
equipment is undamaged and working properly before it is used.
Chapter 4, User Interface – Describes the menus displayed by the Video Processor on its LCD
monitor. This chapter starts with the display layout, and further elaborates on all of the available
sub-menus and the settings and selections that can be made from these menus.
Chapter 5, Operation – Describes the Video Processor screen modes and image/video capture,
review, save, and printing options.
Chapter 6, Adjust the Image Quality – This chapter details the basic steps to adjust and optimize
the endoscopic image before using the Video Processor 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 during the operation of
the Video Processor, and suggests corrective actions that may assist in solving them.
Chapter 9, Warranty and Service – This chapter contains the terms of the LABORIE warranty on the
Video Processor, any restrictions that apply, and user actions that may void the warranty if taken.
This chapter also includes shipping instructions in case the Video Processor must be returned to
LABORIE for repair.
The Appendix details the unit’s technical specifications and electromagnetic compatibility
declarations.
ADDITIONAL INFORMATION
The information in this User Manual is subject to change without notice. If you have any questions
regarding any of the material contained in this manual, or wish to confirm that this is the most-
comprehensive information available for this product, please contact your local distributor or
LABORIE Customer Care.

The PrimeSight UNITY 9000 Video Processor User Manual iii
HOW TO USE THIS MANUAL ...................................................................................................................I
Organization of this Manual ..................................................................................................................i
Additional Information..........................................................................................................................ii
1.0 SYMBOLS AND TERMS...................................................................................................................1
1.1 Symbols Glossary........................................................................................................................1
1.2 Terms ...........................................................................................................................................3
2.0 IMPORTANT INFORMATION ..........................................................................................................4
2.1 Indications for Use ......................................................................................................................4
2.2 Intended Use...............................................................................................................................4
2.3 User Qualifications......................................................................................................................5
2.4 Maintenance and Repair ............................................................................................................5
2.5 Signal Words ...............................................................................................................................5
2.6 Safety Precautions ......................................................................................................................6
2.7 Before Use...................................................................................................................................6
2.8 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 Processor..................................................................17
3.11 Connect Peripheral Equipment...............................................................................................17
3.12 Cables........................................................................................................................................18
3.13 Connect an AC Power Cable...................................................................................................18
3.14 Inspect the Assembled System ...............................................................................................19
3.15 Turn On the Video Processor...................................................................................................19
TABLE OF CONTENTS

The PrimeSight UNITY 9000 Video Processor User Manualiv
Table of Contents
4.0 USER INTERFACE..........................................................................................................................20
4.1 Display Layout...........................................................................................................................20
4.2 Icon Functions...........................................................................................................................22
4.3 Main Controls............................................................................................................................26
5.0 OPERATION...................................................................................................................................39
5.1 System Start-Up ........................................................................................................................39
5.2 Screen Modes ...........................................................................................................................39
5.3 Videoscope Programmable Buttons.......................................................................................40
5.4 Printing Images .........................................................................................................................40
5.5 Backup Images and Data .........................................................................................................40
6.0 ADJUST THE IMAGE QUALITY.....................................................................................................41
6.1 White Balance ...........................................................................................................................41
6.2 Enhance Sub-Menu ..................................................................................................................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 Information..................................................................................................54
9.3 Shipping to LABORIE or Distributor .......................................................................................55
APPENDIX/SPECIFICATIONS.................................................................................................................56
A-1 Specifications ............................................................................................................................56
A-2 Electromagnetic Compatibility Declarations .........................................................................57
A-3 Software License Notifications ................................................................................................62

The PrimeSight UNITY 9000 Video Processor User Manual v
INDEX OF FIGURES
Figure 3-A: UVP-9000 Front View .......................................................................................................................... 11
Figure 3-B: UVP-9000 Rear Panel Left Side .......................................................................................................... 12
Figure 3-C: UVP-9000 Rear Panel Right Side........................................................................................................ 13
Figure 3-D: Flip-Up LCD Monitor on UVP-9000................................................................................................... 14
Figure 3-E: Videoscope Control Buttons.............................................................................................................. 15
Figure 3-F: Connect the Videoscope Cable to the Video Processor................................................................. 17
Figure 3-G: Rear Panel Cable Connections.......................................................................................................... 18
Figure 3-H: AC Power Cable Connectors............................................................................................................. 18
Figure 4-A: Main Display........................................................................................................................................ 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: Manage Users Tab............................................................................................................................... 35
Figure 4-L: Edit User Screen .................................................................................................................................. 35
Figure 4-M: Backup and Restore Tab.................................................................................................................... 36
Figure 4-N: Security Tab......................................................................................................................................... 37
Figure 4-O: Audit Logs........................................................................................................................................... 38
Figure 4-P: Help Screen ......................................................................................................................................... 38
Figure 5-A: Startup Screen..................................................................................................................................... 39
Figure 6-A: Enhance Window................................................................................................................................ 42
Figure 7-A: Fuse Replacement .............................................................................................................................. 48

The PrimeSight UNITY 9000 Video Processor User Manualvi
Table 3.3: The PrimeSight UNITY 9000 Video Processor Standard Set and Accessories ..................................10
Table 4.3.1: Patient Sub-Menu................................................................................................................................26
Table 4.3.2: Patient Directory Sub-Menu...............................................................................................................27
Table 4.3.5-A: Setup Sub-Menu..............................................................................................................................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 Communications Equipment ........................................................................................................61
INDEX OF TABLES

The PrimeSight UNITY 9000 Video Processor User Manual 1
1.1 SYMBOLS GLOSSARY
The symbols listed below can be found on the PrimeSight UNITY 9000 Video Processor and on
other components of the system.
Symbol Symbol Title
[Reference Number] Description of Symbol
Manufacturer
[5.1.1]1Indicates the medical device manufacturer
Alternating Current
[5032]2Denotes device uses alternating current
“OFF” (power)
[5008]2Power off the device
“ON” (power)
[5007]2Power on the device
Stand-by
[5009]2Put device into stand-by mode
Endoscope
[101]3Identifies the connection or control used for the endoscope
Equipotentially
[5021]2Denotes an equipotentially grounding terminal
Caution
[5.4.4]1
Indicates the need for the user to consult the instructions
for use for important cautionary information such as
warnings and precautions
TYPE BF APPLIED PART
[5333]2
Indicates device is Type BF Applied Part (a safety 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]1
Indicates the manufacturer’s catalogue number used to
identify this device
Serial Number
[5.1.7]1
Indicates the manufacturer’s serial number used to
identify a specific medical device
1.0 SYMBOLS AND TERMS
1. ISO 15223-1:2016 – Medical Devices – Symbols to be used with medical device labels, labelling, and information to be supplied – Part 1: General requirements
2. IEC 60417:2002 DB – Graphical symbols for use on equipment
3. IEC 60601-2-18 – Medical electrical equipment – Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
4. IEC 60601-1 – Medical electrical equipment – Part 1: General requirements for basic safety and essential performance

The PrimeSight UNITY 9000 Video Processor User Manual
1 - Symbols and Terms
2
SYMBOL SYMBOL TITLE
[REFERENCE NUMBER] DESCRIPTION OF SYMBOL
Authorized Representative in
the European Community
[5.1.2]1
Indicates the device’s Authorized representative within
the European Community
Temperature Limit
[5.3.7]1
Indicates the temperature limits to which the medical
device can be safely exposed
Humidity Limitation
[5.3.8]1
Indicates the range of humidity to which the medical
device can be safely exposed
Fragile, Handle with Care
[5.3.1]1
Indicates the medical device can be broken or damaged
by not handling carefully
Keep Dry
[5.3.4]1
Indicates the medical device needs to be protected
from moisture
This way up
[0623]5
Indicates the direction which the box should remain
oriented (stored or shipped) to avoid potential damage
to the device
Stacking limit by number
[2403]5
Indicates the devices shall not be vertically stacked
beyond the specified number (4) due to the nature of
the devices
CE Mark
Denotes this equipment has been designed, tested and
certified as essentially 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 hazards. Safety assessment only applies to
the UNITY 9000 Video Processor and videoscopes.
Conforms to AAMI STD ES60601-1:2005 +A1, IEC
60601-1-6:2010 Ed.3+A1, IEC 60601-2-18:2009
Ed.3.
Certified to CSA C22.2#60601-1:2014 Ed.3.
Waste Electrical and
Electronic Equipment
(WEEE)
Do not dispose of this device as household waste. This
product is designated for separate collection at an
appropriate collection facility in accordance to the WEEE
directive
Restriction of Hazardous
Substances (RoHS)
The presence of this symbol on the product or
packaging indicates that this device is RoHS compliant,
in accordance with the RoHS2 Directive
20%
85%
-20°C
60°C
1. ISO 15223-1:2016 – Medical Devices – Symbols to be used with medical device labels, labeling, and information to be supplied – Part 1: General requirements
5. ISO 7000:2014 – Graphical symbols for use on equipment – Registered symbols