Steris Vision1 Operator's Manual

Steris Vision1 Operator's Manual

Imaging console and display system
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11026124
en
Revision E
Vision1™
Imaging Console and Display System
Operator Manual

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Summary of Contents for Steris Vision1

  • Page 1 Vision1™ Imaging Console and Display System Operator Manual 11026124 Revision E...
  • Page 2 © 2024 STERIS. All rights reserved. Published: 2024-6-26 11026124_E Vision1™ Operator Manual...
  • Page 3 Prior to using the Console, read this Operation Manual and become familiar with the features and controls in order to ensure safe use of the Console. Also review the Instructions for Use for your chosen STERIS video imaging scope to ensure safe use of the Imaging System.
  • Page 4: Intended Use

    Product Description The Vision1 Imaging Console and Display System may also be referred to as the Console in this manual and any other documentation related to the STERIS video imaging scope system. Likewise, the STERIS video imaging scope and the STERIS digital scope imaging system may also be referred to as the Scope and the System, respectively, in this manual and any other documentation related to the System.
  • Page 5: Clinical Information

    System. This includes, but is not limited to, the use of system accessories and irrigation/contrast media. The User is required to read this Operations Manual Instructions for Use in its entirety, as well as the STERIS video imaging scope Instructions for Use. Only use the Console and Scope as intended.
  • Page 6 11026124_E Vision1™ Operator Manual...
  • Page 7: Table Of Contents

    There is no image on display in Live View ..............32 6.18 Video does not record when Scope button is engaged properly......32 6.19 View does not zoom when Scope handle button is engaged properly..... 33 EMC Tables ............................34 11026124_E Operator Manual Vision1™...
  • Page 8: Safety Precautions

    • ONLY USE THE CONSOLE WITH A STERIS VIDEO SCOPE. See Product Description • The Vision1 Imaging Console and Display System may also be referred to as the Console in this manual and any other documentation related to the STERIS video imaging system. Likewise, the STERIS video imaging scope and the STERIS digital scope imaging system may also be referred to as the Scope and the System, respectively, in this manual and any other documentation related to the System.
  • Page 9: General Warnings

    Do not use this device in an MR environment. Use of this device in an MR environment could lead to harm (e.g., tissue damage). In all cases, refer to the specifications in this manual and applicable STERIS video scope instructions for use to ensure proper Console performance. Use of the Console outside of the specifications listed in the System Operations Manual Instructions for Use will void the Console warranty and may cause permanent damage to the Console.
  • Page 10: Symbols

    1.3 Symbols The following symbols are used on the Vision1 Imaging Console and Display System labelling and in this Operation Manual Instruction. Unless otherwise indicated symbols are compliant with ISO 15223-1 as indicated by reference number above each symbol.
  • Page 11 Indicates the need Instructions for for the user to consult instructions for use 5.4.4 Warning/Caution Consult instructions for use for cautionary information Waste Stream Do not dispose of Disposal Status electronic products in the general waste stream. 11026124_E Operator Manual Vision1™...
  • Page 12 Indicates that this device poses unacceptable risks to the patient, medical staff or ASTM F2503- other persons within the MR Standard environment. Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment 7.4.9.1 11026124_E Vision1™ Operator Manual...
  • Page 13: Product Description

    Between -20° C (-4° F) and 60° C (140° F) RELATIVE HUMIDITY Between 15% and 90% EXTERNAL POWER 110 V - 230V ~ 50 - 60 Hz SUPPLY MOUNTING PATTERN VESA 100 X 100 mm POWER REQUIREMENTS 12V DC, 5 A 11026124_E Operator Manual Vision1™...
  • Page 14 RESOLUTION: 1920(H) x 1080(V) pixels, 30Hz RESPONSE TIME:20 msec Max INPUT INTERFACE: HDMI port COMPLIANCE IEC 60601-1-2:2014+A1:2020 CISPR 11:2015 +A1:2016 IEC 61000-4-2:2008 IEC 60601-4-3:2010 IEC 61000-4-3:2010 IEC 61000-4-4:2012 IEC 61000-4-5:2005 IEC 61000-4-6:2013 IEC 61000-4-8:2009 IEC 61000-4-11:2004 IEC 61000-3-2:2014 IEC 61000-3-3:2013 11026124_E Vision1™ Operator Manual...
  • Page 15: Device Components

    NUMBER DESCRIPTION FUNCTION Frame Support for LCD Panel Touchscreen with Displays user interface and Antiglare video from STERIS devices USB Ports Allows connection of proprietary USB devices Scope Connector Port to allow connection to STERIS devices Power Button Capacitive touch button to...
  • Page 16 Section 5.2, Console Maintenance VESA Mount Allows unit to be mounted to 100 x 100 mm VESA. Inputs/outputs Power connector, USB Type B (Printer), HDMI IN/OUT IO Cover Protective cover Cable Secures cables from rear of Console. Management 11026124_E Vision1™ Operator Manual...
  • Page 17: Accessories

    HDMI IN USB Type B HDMI OUT Power Fuse (not user serviceable) 2.3 Accessories The following accessories are compatible for use with the Vision1 Imaging Console and Display System: Table 2-5. Compatible Accessories Name Description USB Drive Vision1 Proprietary 256 Bit...
  • Page 18: Installation

    Mounting the Console This section provides an overview of methods to mount the Console in the desired place of operation. Before installation, inspect Console. If there is damage to Console or accessories, do not install. Contact STERIS Customer Service See Service.
  • Page 19: System Setup

    User interface will navigate to Initial Screen. See INITIAL SET UPAfter INITIAL SET UP, a live image will be available within seconds once a scope is plugged in. If Console cannot be turned on, reference Section 6.1, Troubleshooting 11026124_E Operator Manual Vision1™...
  • Page 20: Red Light

    10 receiving power. minutes of inactivity. Tap the screen to wake. NOTE: If the Console screen backlight is off, wake the unit before connecting STERIS Video Imaging Scope. 11026124_E Vision1™ Operator Manual...
  • Page 21: Initial Setup

    3. Tap “SET DATE” field set current DATE. 4. Tap “SET TIME” field and set current TIME. 5. Press OK. 6. User will be navigated to screen instructing to plug in Scope to start procedure. Figure 3-5. Plug in Scope 11026124_E Operator Manual Vision1™...
  • Page 22: How To Connect

    4. If the plug cannot be easily inserted into the port, check for damage on both the plug and connection port. 5. Once the Scope is successfully connected, live video stream will be displayed on the Console live view screen. 11026124_E Vision1™ Operator Manual...
  • Page 23 CONNECTING HDMI INPUT/OUTPUT The Vision1 Console acts as a primary display, by showing live video from compatible STERIS Video Imaging Scopes. The system is also capable of acting as a display panel from other imaging sources utilizing the HDMI input. When there is no HDMI plugged in, system indicates no input detected.
  • Page 24 3 — Installation Figure 3-8. HDMI detected. 1. HDMI IN allows the Vision1 Console to connect to an external HDMI signal and display the input from said HDMI source. 2. Connect HDMI cable to the video out port on the HDMI signal source or external monitor.
  • Page 25: Connecting Usb Storage Devices

    Figure 3-9. USB Port Location The display unit has two USB type A ports that are located on the right side of the Console. STERIS Imaging Console only supports the use of a STERIS proprietary Encrypted drive (See Section 2.3, Accessories ensure protection of patient data.
  • Page 26: Operation

    Section 3.2, System Setup 3. User interface will prompt to insert a Scope to start procedure. 4. Connect the Scope to the Console as described in Section 3.3, How to Connect. USER INTERFACE Figure 4-1. LIVE VIEW 11026124_E Vision1™ Operator Manual...
  • Page 27 VIEW VIDEO HELP. Provides contact information. HDMI CONNECTIVITY – Located in SETTINGS. When compatible HDMI input is inserted, the Console will display the image from external source. SERVICE MODE. Intended to be used by STERIS personnel only. 11026124_E Operator Manual Vision1™...
  • Page 28 Shows user if encrypted drive is connected to system HELP Provides user contact information and basic troubleshooting guide HDMI INPUT User can toggle to HDMI in by tapping the icon. To return to Console view, tap screen SERVICE MODE Intended for STERIS personnel. 11026124_E Vision1™ Operator Manual...
  • Page 29 User can modify date and time (12 hour and 24 hour format) and display or hide from LIVE VIEW. DISPLAY User can modify brightness of the display. Default BRIGHTNESS setting 70%. VOLUME User can adjust volume of speaker. Default setting 50%. LANGUAGE Indicates language selected. 11026124_E Operator Manual Vision1™...
  • Page 30: Procedural Functions

    OPTIONAL- PRINTING AN IMAGE TAKING A PHOTO NOTE: Connect STERIS encrypted USB drive (See Section 2.3, Accessories) to the Console via the USB connection port to save image files. The USB drive can be connected at the beginning of or during the procedure.
  • Page 31 NOTE: The printer and required connection cable are optional accessories and are not included with the System. Follow manufacturer’s instructions for use regarding printer installation. 1. Connect STERIS supported printer (See Section 2.3, Accessories) via the USB Type B port.
  • Page 32: Maintenance

    The Console features a touchscreen display panel specially coated for anti-reflective properties 11026124_E Vision1™ Operator Manual...
  • Page 33 4. After wiping the display panel, inspect all surfaces and features of the display panel and ports to assess visual cleanliness. If any soil or contamination is detected, repeat cleaning steps until device is visually clean. 5. Use a dry, clean, soft cloth to remove any remaining moisture. 11026124_E Operator Manual Vision1™...
  • Page 34: Troubleshooting

    2. Reset the system by holding power button for 8 seconds. The screen will restart with booting process. 3. If step 1 and 2 fail, disconnect power for 10 seconds, then plug in and start system. 11026124_E Vision1™ Operator Manual...
  • Page 35: Console Does Not Power On

    Additional Information Has Scope been plugged in correctly? 1. Disconnect and reconnect Scope. 2. Reset the system by pressing and holding power button for approximately 8 seconds. 3. Replace with new Scope. 4. Contact Customer service 11026124_E Operator Manual Vision1™...
  • Page 36: Console Does Not Wake From Sleep Mode

    6.8 Display settings do not change when adjusted. Condition Display settings (brightness, volume, date/time) do not change when adjusted. General Troubleshooting Additional Information Reset the system 1. Press and hold power button for 8 seconds to reset the system 11026124_E Vision1™ Operator Manual...
  • Page 37: Image Does Not Capture When Scope Button Is Engaged Properly

    2. Make sure the secondary display is on and input is selected to the right input. 3. Check for physical damage to HDMI cable 4. Turn on external display. 5. Replace HDMI cable. 6. Confirm specification of external monitor compatibility. 7. Contact Customer Service. 11026124_E Operator Manual Vision1™...
  • Page 38: Live Image Too Bright Or Dark

    6.15 Scope LED illumination does not change when adjusted from the live view screen. Condition Scope LED illumination does not change when adjusted from the live view screen. General Troubleshooting Additional Information Exit live view 1. Reset the system by holding power button for ~ 8 seconds 11026124_E Vision1™ Operator Manual...
  • Page 39: No Audible Sound

    3. If no video runtime is seen or no audible sound heard, restart the system by pressing and holding the power button for 8 second or unplug the console. 4. If this does not resolve issue Contact Customer Service. 11026124_E Operator Manual Vision1™...
  • Page 40: View Does Not Zoom When Scope Handle Button Is Engaged Properly

    View does not zoom when Scope handle button is engaged properly. NOTE: The Vision1 console is featured by a log system which records certain events from the system for troubleshooting purposes. This log file is accessible under the Service Menu.
  • Page 41: Emc Tables

    EN/IEC 61000- hospital environment. Surge 0.5, 1.0 and 2.0 Pass Mains power quality should be that of a typical commercial or EN/IEC 61000- kV Line to Line hospital 0.5, 1.0 and 2.0 environment. kV Line to Earth 11026124_E Operator Manual Vision1™...
  • Page 42 Field strengths from fixed transmitters, as determined by an electromagnetic site survey, should be less than the compliance levels (V1 and E1). Interference may occur in the vicinity of equipment containing a transmitter. 11026124_E Vision1™ Operator Manual...
  • Page 43 Separation (m) Power (watts) 150 kHz to 80 MHz to 800 MHz 800 MHz to 2.7 MHz D=(3.5/V1) D=(3.5/E1)(√P) (√P) D=(7/E1)(√P) 0.01 0.1166 0.1166 0.2333 0.3689 0.3689 0.7378 1.1666 1.1666 2.3333 3.6893 3.6893 7.3786 11.6666 11.6666 23.3333 11026124_E Operator Manual Vision1™...

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