Hillrom Helion Instructions For Use Manual
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Hillrom Helion Instructions For Use Manual

Video management system
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Instructions for use
Helion
Video Management System
Read the instructions for use carefully before using the
ENGLISH
product and keep them safe for future reference.
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  • Page 1 Instructions for use Helion Video Management System Read the instructions for use carefully before using the ENGLISH product and keep them safe for future reference. en-US...
  • Page 2 This page is intentionally blank.
  • Page 3 VR401111-1TND Helion Main Unit AR VR401111-2 Helion Main Unit ARD VR401111-2D Helion Main Unit ARSD VR401111-2DT Helion Main Unit ARS VR401111-2T Helion Main Unit SSD R VR401111-3 Helion 4K VR401112 Helion 4K Plus VR401113 Helion Conference CM401326 Helion Rack (115V)
  • Page 4 Helion VIDEOMED S.r.l. declines any liability for improper use of the system and/or for damage caused as a result of operations not covered by the technical documentation. 80028000_030_C – 773607 – 2021-09-01...
  • Page 5 Helion PREFACE All rights reserved. No part of this publication may be copied, distributed, translated into other languages or transmitted by any electronic or mechanical means, including photocopying, recording or any other storage and retrieval system, for other purposes that are not exclusively personal use by the buyer, without the express written permission of the Manufacturer.
  • Page 6 Helion This page is intentionally blank. 80028000_030_C – 773607 – 2021-09-01...

  • Page 7: Table Of Contents

    Contents Contents System identification ............9 Identification plates .
  • Page 8 Contents 6.3.4.5 Enable camera setting (Preset) ..........51 “Recording”...

  • Page 9: System Identification

    System identification Identification plates The Helion Video Management System units are fitted with identification plates. Each plate contains the identification details of the unit to be quoted in case of need to VIDEOMED S.r.l. The plates present are shown below:...
  • Page 10 A H F I N K E O J E D I D P P J H E F K Helion Main Unit SSD R A K H L N D F D K I O I C N N O D L E K...
  • Page 11 A H F I N K E O J E D I D M K A A J F K Helion 4K Plus A L A I N D F D L P O O N C B O M L F K...

  • Page 12: Reference Standards

    System identification Reference standards VIDEOMED S.r.l. declares that the Helion Video Management System complies with the specific standards of the medical sector. Legislation and rules applicable to the United States of America (USA) countries: Standard Description 21 CFR Part 820...

  • Page 13: Warranty

    System identification Legislation and rules applicable to European Union (EU) countries: Standard Description Regulation (EU) 2017/745 Regulation on medical devices amending Directive 93/42/EEC will enter into force on 26 May 2021 93/42/EEC Medical Devices Directive (MDD) and f.m. 2007/47/EC EN 1041:2008 Information provided by the manufacturer of medical devices EN ISO 13485:2016 Management systems for the quality of medical devices...

  • Page 14: General Preliminary Information

    General preliminary information General preliminary information Recipients of the instructions for use The instructions for use of Helion Video Management System are intended for operators trained and authorized to handle it. Operator training must be documented. The instructions for use contain the topics that refer to a correct use of the system, in order to maintain its functional and qualitative characteristics unchanged over time.

  • Page 15: Personnel Qualifications

    User Person suitably trained or who, thanks to their professional qualification, is authorized to operate and use the Helion Video Management System in the activities required. They are responsible for the correct and safe operation of the system and ensures that it is used solely for the intended purpose.
  • Page 16 AMD 1 (2012), CAN/CSA-C22.2 No. 60601-1 (2014) Consult instructions for use (IFU). A copy of the IFU is available on this website. A printed copy of the IFU can be ordered from Hillrom for delivery within 7 calendar days. hillrom.co.uk 80028000_030_C – 773607 – 2021-09-01...

  • Page 17: Safety Information

    Safety information Safety information General safety warnings The Helion Video Management System must be used by suitably trained personnel. DANGER ELECTRIC SHOCK FROM DAMAGED MAINS POWER CABLE! Check the mains power cable before connecting it and do not use it if it has been crushed or if the insulation is damaged.

  • Page 18: Electromagnetic Compatibility

    MEASUREMENT OF DISPERSAL CURRENTS! It is necessary to measure the leakage currents with the circuits downstream of the Helion system open. Otherwise, the leakage currents of these circuits will be added to those of the Helion system. Electromagnetic compatibility The Helion Video Management System supplied contains...
  • Page 19 Safety information Guidance and manufacturer's declaration - Electromagnetic immunity The product is suitable for use in a specific electromagnetic environment. The customer and / or the user of the product must ensure that it is used in an electromagnetic environment as described below: IMMUNITY test IEC test level Compliance...

  • Page 20: Useful Life Of The System

    Safety information Guidance and manufacturer's declaration - Range and frequency level: RF wireless communication equipment Test frequency Modulation Minimum IMMUNITY Applied IMMUNITY (MHz) level (V / m) level (V / m) ** Pulse modulation: 18 Hz  * FM + 5 Hz deviation: 1 kHz sine ...

  • Page 21: Cleaning

    Do not use any cleaning products. This paragraph indicates how to perform the cleaning on the Helion system. Cleaning shall be performed on a regular basis (at least once a week) to ensure the components remain in good working order and intact.

  • Page 22: System Description

    System description System description Intended use The Helion Video Management System is a medical video- communication system used exclusively for displaying and managing already existing audio-video sources, and to control an operating light within the specifications established by the manufacturer.

  • Page 23: Use Associated With Other Medical Devices

    If a medical device is installed at a later date, installation must be carried out as specified in IEC standard 60601-1. Environmental conditions for the operation and storage of Helion must be met, see “Technical data” paragraph. Obligations and prohibitions...

  • Page 24: Personnel Prohibitions

    System description 4.4.1 Personnel prohibitions In particular the personnel must not: – use the system improperly, i.e. for uses other than those indicated in paragraph “Intended use”; – replace or modify system components without the permission of the Manufacturer; – use the system as a support point even if not operational (resulting in the risk of falling and/or damaging the system itself);...

  • Page 25: Technical Data

    System description Technical data MAIN UNIT - Technical Specs Video Inputs 18 (14 DVI, 2 3G-SDI, 2 CVBS) Monitor Outputs 10 DVI over CAT6/7 or optic fiber Supported Resolutions Standard video PAL (720 x 576) HDTV (1280 x 720) Full HDTV (1920 x 1080p) PC resolution (1024 x 768, 1280 x 1024, 1600 x 1200, 1920 x 1200) UHD / 4K option with 4K unit Dimensions...
  • Page 26 System description CONFERENCE UNIT - Technical Specs Standard Video H.263, H.263+, H.263++, H.264, H.264 High Profile, H.264 SVC. Encoding up to 1920 x 1080p 60fps Video Inputs 2 Inputs: – 2 x HD video in (1080p60/720p60) Dimensions 44 x 430 x 450 mm Power Supply 100-240 V 50-60Hz AC Video Outputs...
  • Page 27 System description 4K UNIT - Technical Specs Video Inputs 5 HDMI Ports Video Outputs 5 HDMI Ports Supported Resolutions Up to 4096 x 2160 at 60Hz Transmission To Optic Fiber Cabling Monitor Additional Ports 5 x DVI over CAT 6/7 output scaled to FullHD 1080 5 x DVI over CAT 6/7 pass-through input (FullHD 1080) Dimensions 44 x 430 x 450 mm...
  • Page 28 System description 4K PLUS UNIT - Technical Specs Video Inputs 2 HDMI Ports 2 Display Port Video Outputs 2 HDMI Ports 2 Display Port Supported Resolutions Up to 4096 x 2160 at 60Hz Transmission To Optic Fiber cabling Monitor Additional Ports 4 x DVI over CAT6/7 output scaled to FullHD 1080 4 x DVI over CAT6/7 pass-through input (FullHD 1080) Dimensions...
  • Page 29 System description RACK UNIT - Technical Specs Dimensions 800 x 600 x 757 mm Color RAL 7016 puckered Environmental Operating temperature: +10/+40 °C conditions Operating relative humidity range: 30% to 75% Operating atmospheric pressure range: 70.0 kPa to 106.0 kPa Storage temperature: -40/+70 °C Storage relative humidity range: 10% to 100% including condensation...

  • Page 30: Measurement And Weight Layout

    System description Measurement and weight layout MAIN UNIT Dimensions 133 x 430 x 450 mm Unit Weight 13.5 kg Rack Dimensions (optional) Rack Brackets (optional) 80028000_030_C – 773607 – 2021-09-01...
  • Page 31 System description CONFERENCE UNIT Dimensions 44 x 430 x 450 mm Unit Weight 8 kg Rack Dimensions (optional) Rack Brackets (optional) 80028000_030_C – 773607 – 2021-09-01...
  • Page 32 System description 4K UNIT Dimensions 44 x 430 x 450 mm Unit Weight 5.5 kg Rack Dimensions (optional) Rack Brackets (optional) 80028000_030_C – 773607 – 2021-09-01...
  • Page 33 System description 4K PLUS UNIT Dimensions 44 x 430 x 450 mm Unit Weight 5.5 kg Rack Dimensions (optional) Rack Brackets (optional) 80028000_030_C – 773607 – 2021-09-01...
  • Page 34 System description RACK UNIT Dimensions 800 x 600 x 757 mm Unit Weight 64 kg ADJUSTABLE FOOT HEIGHT 80028000_030_C – 773607 – 2021-09-01...

  • Page 35: System Components

    System description System components The Helion Video Management System has a modular structure composed of 3 operating units that can be used simultaneously. The only unit that can operate independently is the Main unit. MAIN UNIT CONFERENCE UNIT 4K UNIT or 4K PLUS UNIT 4.7.1...

  • Page 36: Conference Unit

    System description 4.7.2 Conference unit The Conference unit is equipped with Full HD video conference technology that allows the exchange of information in video conference with the operating room by sharing high resolution images and videos outside the room. The following connection ports are located on the back of the unit. The connection cables are supplied VIDEOMED S.r.l.

  • Page 37: Control Software

    VIDEO CONFERENCE function. This function allows two-way audio/ video communication. The Helion Video Management System also assures control and management of the main devices installed in the operating room: – PTZ Roomcam; – surgical lights with surgical video camera.

  • Page 38: Operation

    Operation Operation First system start The Helion Video Management System is delivered to the operator by the authorized installer technical personnel from VIDEOMED S.r.l. System commissioning requires for the operator to be adequately trained on the functional and visual controls, on the adjustments and calibration, on cleaning and maintenance of the system, and lastly on the applicable user instructions.

  • Page 39: Connection To The Sources

    Operation Connection to the sources When a new video source is connected to the system, its dynamic Preview (frame) is displayed in Source List, showing the name of the socket/line used. The Preview updates periodically as long as the signal remains active.

  • Page 40: System Start-Up/Shutdown With Remote Button

    Operation System start-up/shutdown with remote button The Helion Video Management System allows the units to be restarted via a remote on/off button installed inside the operating room (typically on a pendant panel or wall unit). Thanks to this solution, the operator can manage the entire video management system without having to access the Technical rack.

  • Page 41: User Interface

    User Interface User Interface General description of the user interface The user interface is divided as follows: Element Description STATUS BAR It contains important information such as the patient's name and the number of recorded media related to them. Information such as the date, time and a dashboard showing the status of the recording, the video conference, the streaming and the advanced modes “Privacy Mode”, “Do Not Disturb”...

  • Page 42: Control Touchscreen

    User Interface Control touchscreen The control screen is a high-resolution touchscreen. The user interface buttons are activated with a brief touch of the finger, or by swiping. The control screen has its own setup menu from which the monitor settings can be accessed: –...

  • Page 43: Video Routing" Function

    User Interface “Video Routing” function The Video Routing function allows you to manage images from the various sources present in the operating room, such as: – endoscope, – surgical video camera, – roomcam. These video signals can be routed to any monitor in the operating room.

  • Page 44: Live Preview

    User Interface To remove the signal from a monitor, select it from the Monitor List and press 6.3.1 Live Preview With the Live Preview function it is possible to enlarge or reduce the preview of the video signal of each connected source. If the preview is enlarged, it will only appear momentarily on the screen.
  • Page 45 User Interface The following icons are present in the Live Preview window: Icon Function Enables to start/stop recording of the displayed signal. If the icon is gray, it indicates that the function is not active. To activate the function it is required to select a patient from the list (refer to paragraph “Selecting a patient present in the list”).

  • Page 46: Quick Access - Recording

    User Interface 6.3.2 Quick Access - Recording To start the recording it is possible to use a quick activation system directly from the Video Routing screen. There is a dedicated Recording screen to access the advanced functions. There is a dedicated Recording function to perform the recording. In any case, it is possible to use an additional quick activation system from the Video Routing function.

  • Page 47: Quick Access - Streaming

    User Interface 6.3.3 Quick Access - Streaming To activate the streaming session, proceed as follows: Step Image Press the box of a Preview to start streaming the signal from one of the connected sources. When streaming is active, the button is in white background in the box of the selected source and is disabled in the Previews of the remaining...

  • Page 48: Roomcam Zoom Adjustment

    User Interface 6.3.4.1 Roomcam zoom adjustment To adjust the zoom of the Roomcam, proceed as follows: Step Image to adjust the zoom to obtain the desired image (view). 6.3.4.2 Roomcam movement adjustment To adjust the movement of the Roomcam, proceed as follows: Step Image Use the arrows...

  • Page 49: Save Camera Setting (Preset)

    User Interface 6.3.4.3 Save camera setting (Preset) To save a specific video camera setting (Preset), proceed as follows: Step Image After adjusting the video camera to the desired position, press Enter the name to be assigned and press to confirm. The new Preset with the name assigned will appear on the list on the side.

  • Page 50: Delete Camera Setting (Preset)

    User Interface 6.3.4.4 Delete camera setting (Preset) To delete a video camera setting from the Preset list, proceed as follows: Step Image Press Press and hold the button until it is deleted. 80028000_030_C – 773607 – 2021-09-01...

  • Page 51: Enable Camera Setting (Preset)

    User Interface 6.3.4.5 Enable camera setting (Preset) To activate a video camera Preset, proceed as follows: Step Image Press on the desired Preset in the list. Press to confirm the Preset selection. “Recording” function The Recording function enables to capture snapshots and record video from the signals connected to the system.
  • Page 52 User Interface The main Recording screen is divided as follows: source list view of the two recording channels list of snapshots and videos stored The user may view and reproduce any material stored during the surgical activity (images and video) at any time by pressing the icon .

  • Page 53: Image Data Post-Processing

    User Interface 6.4.1 Image data post-processing By using locally stored data it is possible to: – create video sequences from screenshots saved during the operation (MATS - Movie Around The Snap), – create still images generated from previously recorded video, –...

  • Page 54: Recording

    User Interface It is not possible to start recording if a reference patient is not present. 6.4.3 Recording To perform the recording from the Recording function, proceed as follows: Step Image Press the box of a Recording Channel to start recording a signal.

  • Page 55: Snapshot And Video Playback

    User Interface 6.4.4 Snapshot and video playback To play snapshots and videos, proceed as follows: Step Image Press to view all images and videos related to the selected patient. Press the icon to enlarge the single media. A new window appears which, depending on the file selected (image or video), allows you to: Icon...

  • Page 56: Crop Video

    User Interface 6.4.5 Crop video To cut the videos, proceed as follows: Step Image Press to view all images and videos related to the selected patient. Press the icon to enlarge the single element. Press the icon. A cursor appears on the progress bar.
  • Page 57 User Interface Step Image Once the cutting points are determined, extract the portion of the video by pressing A new video appears in the photo/video list of the same patient. 80028000_030_C – 773607 – 2021-09-01...

  • Page 58: Export Images And Videos

    User Interface 6.4.6 Export images and videos Click on the icon to access the folder for storing images and videos of the selected patient. This operation must be performed to close the patient file and export the files. A screen with all the captured images and videos is displayed. The following icons are present in the Export window: Icon Function...
  • Page 59 User Interface Step Image Press (on the right side of the screen) to send the files to the selected destinations. By pressing files are sent to the selected destinations and the patient's session will be deleted. The activation of each of the export options shown above depends on settings that must be authorized and guided by the IT managers of the hospital.

  • Page 60: Delete Images And Videos

    User Interface 6.4.7 Delete images and videos Click on the icon to access the folder for storing images and videos of the selected patient. To delete images and videos, proceed as follows: Step Image Select the videos or images you wish to delete by clicking directly on their thumbnail.

  • Page 61: Video Conference" Function

    User Interface “Video Conference” function The Video Conference function allows video conferencing in two- way audio and video connection from the operating room to external rooms: – external participants located in other rooms or areas of the building are connected to the device via LAN connection, –...

  • Page 62: Select The Signals To Be Sent By Video Conference

    User Interface The main Video Conference screen is divided as follows: source list view of the two video conference channels When the video conference is active, the dashboard receiver icon turns green 6.5.1 Select the signals to be sent by video conference From the Source List, drag the source you wish to send in video conference in the Primary Channel (or Secondary Channel) box.

  • Page 63: Removing The Signals To Be Sent By Video Conference

    User Interface 6.5.2 Removing the signals to be sent by video conference Press one of the boxes related to the primary and/or secondary video conference channel and then to the icon which will be shown inside it to remove the video signal from the video conference.

  • Page 64: Call Recipient Selection

    User Interface 6.5.3 Call recipient selection To select the recipient of the call, press the relative icon (depending on the mode) on the right side of the screen. The icons are described below: Icon Description Image Enables to select a name from the contact list.

  • Page 65: Call Start

    User Interface 6.5.4 Call start Once the call recipient has been selected, the call can be started. To start the call, proceed as follows: Step Image Press the green call button The call button turns red and indicates the option to end the call.

  • Page 66: Patient Data Management

    User Interface 6.6.1 Patient data management On the side menu, press the icon to access patient data management. On the screen displayed, when the icon is pressed, the list of patients [A], already entered and divided between those imported by the Worklist (if present), and those previously manually selected or inserted, is displayed.

  • Page 67: Entering A New Patient

    User Interface Step Image Press to confirm the selection. 6.6.1.2 Entering a new patient To enter a new patient, proceed as follows: Step Image Select the icon on the right of the screen. The window for filling in patient data is displayed. Enter the data for the new patient.

  • Page 68: Entering An Emergency Patient

    User Interface Step Image Once the mandatory data have been filled in, it is possible to save the new patient by pressing or cancel the insertion with 6.6.1.3 Entering an emergency patient If the conditions do not allow new patient data to be filled in completely manually, through this option it is possible to quickly create a name with random ID called Emergency Patient.

  • Page 69: Searching For A Patient Present In A List

    User Interface 6.6.1.4 Searching for a patient present in a list To search for a patient already in the list, proceed as follows: Step Image Enter the surname or ID in the specific field in the right section. 6.6.1.5 Patient master data modification To modify a patient’s master data , proceed as follows: Step Image...

  • Page 70: Accessing The Worklist

    User Interface 6.6.1.6 Accessing the worklist If the Helion Video Management System is configured to dialogue with the centralized master data management system, the patient list relative to the date/room/surgeon can be called up by using button. To access the worklist, proceed as follows:...

  • Page 71: Check-List

    User Interface 6.6.2 Check-List On the side menu, press the icon to access the Check-List screens. The Check-List only activates after selecting a patient. In the section [A] it is possible to manage the operative procedure by following a sequence of questions and instructions, defined by the World Health Organization as default, concerning each stage of the surgical procedure.

  • Page 72: Preset

    User Interface 6.6.3 Preset On the side menu, press the icon to access the Preset screens. The Preset enable to save room settings configurations. It will then be possible to recall the configurations by pressing the relative icons. The main screen is divided as follows: Preset List 80028000_030_C –...

  • Page 73: Preset Setting

    User Interface 6.6.3.1 Preset setting To set a new Preset, proceed as follows: Step Image Set the desired room layout (Routing Video, Recording Channel, Conference Channel, Setting Audio, Operating Light Setting). Press the button The configuration window opens. Enter the name to be assigned to the new Preset and add a description in the appropriate field below (optional).

  • Page 74: Enabling Preset

    User Interface Step Image Press confirm. 6.6.3.2 Enabling Preset To activate a Preset in the list, proceed as follows: Step Image Select the desired Preset from the Preset List. The configuration window opens. Apply the Preset by pressing Press perform changes to the Preset. Save the changes by pressing Press the icon to automatically activate the Preset...

  • Page 75: Multiview

    User Interface 6.6.4 Multiview On the side menu, press the icon to access the Multiview screen. The Multiview function enables to combine multiple Inputs (up to a maximum of 4) into a single Output signal. The main screen is divided as follows: Source List Multiview 80028000_030_C –...

  • Page 76: Multiview Setting

    User Interface 6.6.4.1 Multiview setting To set the Multiview, proceed as follows: Step Image Select the desired layout from those indicated: Icon Function Picture and Picture Quadview Picture Over Picture Picture In Picture Drag the images (one at a time) from the Source List and drop them into the corresponding boxes.

  • Page 77: Audio Control

    User Interface 6.6.5 Audio control On the side menu, press the icon to access the Audio Control screen. In the Audio Control section it is possible to set the volume levels of the inputs (microphones) and outputs (speakers in the room).

  • Page 78: Volume Adjustment

    User Interface 6.6.5.1 Volume adjustment To adjust the volume of the microphones or line inputs, proceed as follows: Step Image Operate on the volume bar of the microphones or line inputs according to the volume to be modified. Press along the bar to increase or decrease the volume of the microphones or line inputs.

  • Page 79: Disabling Microphones And Audio

    User Interface 6.6.5.2 Disabling microphones and audio To disable the microphones or line inputs, proceed as follows: Step Image Press to disable the microphone. Press to turn off speaker volume. 80028000_030_C – 773607 – 2021-09-01...

  • Page 80: Management Of Surgical Lights

    Satellite The image shows the case where the lamp control system cannot be reached. Helion Video Management System assures the option of controlling the Trumpf Medical surgical operating lights, thanks to reproduction of the light control console through the graphic interface.

  • Page 81: Environmental Control Panel Management

    The control panel management screen can be used only if Operamed devices are present in the operating room. The Helion Video Management System of VIDEOMED S.r.l. enables only Operamed control panels to be associated. 80028000_030_C – 773607 – 2021-09-01...

  • Page 82: Lock With Pin" Function

    User Interface “Lock with PIN” function Helion Video Management System includes a Lock function to lock the touchscreen by using a PIN. To lock the touchscreen, proceed as follows: Step Image Press to lock the screen. Enter the PIN code to unlock the touch screen, using the highlighted numeric keypad.

  • Page 83: Login" Function

    Login screen requires 2 mandatory fields to fill in, Username and Password, in order to access the system. Once the correct credentials have been entered, the system will show the initial Helion graphical interface (Video Routing interface). Press the icon to Logout and be redirected to the credentials screen.

  • Page 84: Disposal Instructions

    Disposal instructions Disposal instructions Electrical equipment that is no longer in use must not be disposed of as normal urban waste. The substances and materials contained in them must be disposed of separately in an appropriate way, so that they can be recycled for the production of new products. VIDEOMED S.r.l.

  • Page 85: Annex I - Short Manual

    Annex I - Short manual Annex I - Short manual Video Routing To send a video signal to a monitor, drag the relative image from the list of available sources and drop it in one of the enabled monitors. The Preview of the video signal sent will be displayed inside the relative Monitor icon and updated periodically.

  • Page 86: Patient Data

    Annex I - Short manual Patient data The list of previously created patients is displayed on the main screen. To insert a new patient, select one of the options in the right section: Manual insertion Enter the data relating to the new patient (the fields marked with * are mandatory).
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