Summary of Contents for Hillrom Helion Main Unit R
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Instructions for use Helion Video Management System Read the instructions for use carefully prior to using the ENGLISH product and keep them safe for future reference. en-GB...
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Language ID: Version: Material number: 774259 Publication date: 2021-09-01 This document applies to the following units sold: Product designation Helion Main Unit R VR401111-1 Helion Main Unit VR401111-1ND Helion Main Unit RD VR401111-1D Helion Main Unit RSD VR401111-1DT Helion Main Unit RS...
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Helion VIDEOMED S.r.l. waives any liability for improper use of the system and/or for damage caused as a result of operations not covered by the technical documentation. 80028681_002_C – 774259 – 2021-09-01...
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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 the buyer’s personal use, without the manufacturer’s express written permission.
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Helion This page is intentionally left blank. 80028681_002_C – 774259 – 2021-09-01...
A H F I N K E O J E D J C J L K K A F K Helion Main Unit R A L C J N D F C L I K D L D D F J L N K...
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35010 Limena, Italy 2021-08-11 Made In Italy E464244 hillrom.co.uk INPUT: 100-240V~1.1-2.0A 50/60 Hz FUSES RATING: 2X 250VAC - T3.15A A L G O A O A I B K H I A L F N C J D K A H F I N K E O J E D I C I J P J N E K...
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35010 Limena, Italy 2021-08-11 Made In Italy E464244 hillrom.co.uk INPUT: 100-240V~0.2-0.48A 50/60 Hz FUSES RATING: 2X 250VAC - T1.6A A L G O A O A I B K H K A L F N C J D K A H F I N K E O J A D J D J L D O O F K...
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): Standard Description 21 CFR Part 820 Quality System Regulation 21 CFR Part 821 Medical Device Tracking Requirements 21 CFR Part 803, 806, 807...
System identification Legislation and rules applicable to European Union (EU) countries: Standard Description Regulation (EU) 2017/745 The 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 supplied by the manufacturer of medical devices EN ISO 13485:2016...
General preliminary information General preliminary information Recipients of the instructions for use The instructions for use of the Helion Video Management System are intended for operators trained and authorised to operate it. Operator training must be documented. The instructions for use contain topics referring to correct use of the system, so as to keep its functional and qualitative characteristics unchanged over time.
General preliminary information Personnel qualifications Consult the following table in order to establish personnel skills and qualifications: Qualification Description Operator Natural or legal person (for example, a doctor or a hospital) who owns and uses the Helion Video Management System. They must provide a safe system and adequately instruct the user in the intended and permitted use of the system.
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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 80028681_002_C – 774259 – 2021-09-01...
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 the insulation is damaged. DANGER ELECTRIC SHOCK FROM PRESENCE OF EXPOSED LIVE PARTS! It is also recommended to periodically check the integrity of the...
Safety information CAUTION COMPULSORY MEASUREMENT OF DISPERSAL CURRENTS It is necessary to measure leakage currents with 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 electronic components subject to Electromagnetic Compatibility regulations, which are affected by conducted and radiated...
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Safety information Guidance and manufacturer's declaration - Electromagnetic immunity The product is suitable for use in a specific electromagnetic environment. The customer and / or user of the product must ensure that it is used in an electromagnetic environment as described below: Immunity test IEC test level Compliance...
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 ...
Safety information Cleaning CAUTION Do not use any cleaning products. This paragraph describes how to clean the Helion system. Cleaning shall be performed on a regular basis (at least once a week) to ensure components remain intact and in good working order.
System description System description Intended use The Helion Video Management System is a medical video communication system used exclusively to display and manage existing audio-video sources, and to control an operating light within the specifications established by the manufacturer. The intended use requires the following: –...
System description Reasonably foreseeable misuse Cases of reasonably foreseeable misuse, which are strictly prohibited, are listed below: – using the system in areas at risk of explosion; – using the system near strong electromagnetic fields; – using the system in a different way to what is required in paragraph “Intended use”.
System description Obligations and prohibitions The VIDEOMED Helion system must only be used by medical and paramedical personnel with the requisite professional qualifications, who have read these instructions for use and have been adequately trained in the use of the system. The training is certified through participation in the training course entitled “training for healthcare personnel in the use of Helion”.
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 fibre 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...
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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...
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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 fibre 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...
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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 fibre 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...
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System description Rack unit - Technical Specs Dimensions 800 x 600 x 757 mm Colour 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...
System description Measurement and weight layout Main unit Dimensions 133 x 430 x 450 mm Unit weight 13.5 kg Rack dimensions (optional) Rack Dimensions (optional) Rack brackets (optional) Rack Brackets (optional) 80028681_002_C – 774259 – 2021-09-01...
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System description Conference unit Dimensions 44 x 430 x 450 mm Unit weight 8 kg Rack dimensions (optional) Rack Dimensions (optional) Rack brackets (optional) Rack Brackets (optional) 80028681_002_C – 774259 – 2021-09-01...
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System description 4K Unit Dimensions 44 x 430 x 450 mm Unit weight 5.5 kg Rack dimensions (optional) Rack Dimensions (optional) Rack brackets (optional) Rack Brackets (optional) 80028681_002_C – 774259 – 2021-09-01...
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System description 4K Plus unit Dimensions 44 x 430 x 450 mm Unit weight 5.5 kg Rack dimensions (optional) Rack Dimensions (optional) Rack brackets (optional) Rack Brackets (optional) 80028681_002_C – 774259 – 2021-09-01...
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System description Rack unit Dimensions 800 x 600 x 757 mm Unit weight 64 kg ADJUSTABLE FOOT HEIGHT Adjustable foot height 80028681_002_C – 774259 – 2021-09-01...
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 Main unit The following functions are available via the Main 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 theatre by sharing high resolution images and videos outside the room. The following connection ports can be found on the back of the unit.
System description 4.7.5 Control software The management software of the Helion Video Management System makes it possible to control and manage each functional unit. A lower selection bar (always visible) allows the software sections to be uniquely identified based on the function performed. The sections of the selection bar are described below: Function Description...
Operation Operation First system start The Helion Video Management System is delivered to the operator by authorised installation technical personnel from VIDEOMED S.r.l. System commissioning requires the operator to be adequately trained in the functional and visual controls, adjustments and calibration, cleaning and maintenance of the system, and also in the applicable user instructions.
Operation Connection to sources When a new video source is connected to the system, a dynamic Preview (frame) is displayed in the Source List, showing the name of the socket/line used. The Preview updates periodically as long as the signal remains active.
Operation System start-up/shutdown by remote button The Helion Video Management System allows units to be restarted via a remote on/off button installed inside the operating theatre (typically on a pendant panel or wall unit). Using this solution, the operator can manage the entire video management system without needing to access the Technical rack.
User Interface User Interface General description of the user interface The user interface is divided up 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, video conference, streaming and advanced modes “Privacy Mode”, “Do Not Disturb”...
User Interface Control touchscreen The control screen is a high-resolution touchscreen. The user interface buttons are activated by a brief touch of the finger, or by swiping. The control screen has its own setup menu to access the monitor settings: –...
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User Interface The main Video Routing screen is divided as follows: list of sources connected list of monitors enabled To send a video signal to a monitor, drag the relevant image from the Source List [A] available and drop it into one of the enabled monitors [B] by drag&drop.
User Interface 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. To display the Live Preview of one of the signals available in the Source list, proceed as follows: Step...
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User Interface The following icons are present in the Live Preview window: Icon Function Makes it possible to start/stop recording of the displayed signal. If the icon is grey, this indicates that the function is not active. To activate the function, it is necessary to select a patient from the list (refer to the paragraph “Selecting a patient in the list”).
User Interface 6.3.2 Quick Access - Recording It is possible to use a quick activation system directly from the Video Routing screen to start recording. A dedicated Recording screen is available to access advanced functions. A dedicated Recording function enables recording. In any case, it is possible to use an additional quick activation system from the Video Routing function.
User Interface 6.3.3 Quick Access - Streaming To activate streaming, proceed as follows: Step Image Press the icon of a Preview to start streaming the signal from one of the connected sources. When streaming is active, the button is in a white background in the icon of the selected source and is disabled in the Previews of the remaining...
User Interface 6.3.4 Ptz camera control If activated on a controllable camera signal, the Live Preview function will allow access to its movement controls. 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).
User Interface 6.3.4.3 Save camera setting (Preset) To save a specific video camera setting (Preset), proceed as follows: Step Image After the video camera has been adjusted to the desired position, press Enter the name to be assigned and press to confirm.
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. 80028681_002_C – 774259 – 2021-09-01...
User Interface 6.3.4.5 Enable camera setting (Preset) To activate a video camera Preset, proceed as follows: Step Image Press the desired Preset in the list. Press to confirm the Preset selection. “Recording” function The Recording function makes it possible to capture snapshots and record video from the signals connected to the system.
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User Interface The main Recording screen is divided as follows: source list view of the two recording channels list of screenshots 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 .
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, –...
User Interface Channel selection and recording will in no way affect the signals sent to the monitors via Video Routing. It is not possible to start recording if a reference patient is not present. 6.4.3 Recording To record from the Recording function, proceed as follows: Step Image Press the...
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 individual media item. A new window appears which, depending on the file selected (image or video), allows you to: Icon...
User Interface 6.4.5 Cutting video To cut 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 item. Press the icon. A cursor appears on the progress bar.
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User Interface Step Image Once the cutting points have been determined, extract the portion of the video by pressing A new video appears in the photo/video list for the same patient. 80028681_002_C – 774259 – 2021-09-01...
User Interface 6.4.6 Export images and videos Click on the icon to access the folder for storing images and videos for the selected patient. This step must be performed to close the patient file and export the files. A screen is displayed with all the captured images and videos. The following icons are available in the Export window: Icon Function...
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User Interface Step Image Press (on the right side of the screen) to send the files to the selected destinations. By pressing , the files are sent to the selected destinations and the patient's session is deleted. Activation of each of the export options shown above depends on settings that need to be authorised and guided by the hospital’s IT managers.
User Interface 6.4.7 Delete images and videos Click on the icon to access the folder for storing images and videos for 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 thumbnails.
User Interface “Video Conference” function The Video Conference function allows video conferencing in a two-way audio and video connection from the operating theatre to external rooms: – external participants located in other rooms or areas of the building are connected to the device via LAN connection, –...
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 Selecting the signals to be sent by video conference From the Source List, drag the source you wish to send via video conference in the Primary Channel (or Secondary Channel) box.
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 the icon to be shown inside it to remove the video signal from the video conference. The thus removed video signal will no longer be shared with video conference participants.
User Interface 6.5.3 Call recipient selection To select the call recipient, press the relevant icon (depending on the mode) on the right side of the screen. The icons are described below: Icon Description Image Enables selection of a name from the contact list. Enables selection of a name/address from those indicated in the calls sent/...
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 indicate the option to end the call.
User Interface 6.6.1 Patient data management Press the icon on the side menu to access patient data management. On the screen displayed, after pressing the icon, 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.
User Interface 6.6.1.1 Selecting a patient in the list To select a patient who is already in the list, proceed as follows: Step Image Select the patient. Press to confirm the selection. 80028681_002_C – 774259 – 2021-09-01...
User Interface 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 patient data entry window is displayed. Enter the data for the new patient. Fields marked with a * are mandatory.
User Interface 6.6.1.3 Entering an emergency patient If the conditions do not allow new patient data to be entered completely manually, using this option, it is possible to quickly create a name with a random ID called Emergency Patient. In terms of available functionalities and management, the Emergency Patient is similar to any patient entered manually or by calling up the Worklist.
User Interface 6.6.1.4 Searching for a patient in a list To search for a patient already in the list, proceed as follows: Step Image Enter their surname or ID in the specific field in the section on the right. 6.6.1.5 Patient master data modification To modify a patient’s master data, proceed as follows: Step...
User Interface 6.6.1.6 Accessing the worklist If the Helion Video Management System is configured to communicate with the centralised master data management system, the patient list for the date/room/surgeon can be called up using the button. To access the worklist, proceed as follows: Step Image Press the...
User Interface 6.6.2 Check-List In the side menu, press the icon to access the Check-List screens. The Check-List is only activated after a patient has been selected. In section [A], it is possible to manage the surgical procedure by following a sequence of questions and instructions, as defined by the World Health Organisation as default, regarding each stage of the surgical procedure.
User Interface 6.6.3 Preset Press the icon on the side menu to access the Preset screens. The Preset makes it possible to save room setting configurations. It will then be possible to recall the configurations by pressing the relevant icons. The main screen is divided as follows: Preset List 80028681_002_C –...
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).
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User Interface Step Image Select / deselect the settings to be included in the configuration by pressing the relevant icons among those listed. Press confirm. 80028681_002_C – 774259 – 2021-09-01...
User Interface 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 to make changes to the Preset. Save the changes by pressing Press the icon to automatically activate the Preset...
User Interface 6.6.4 Multiview Press the icon on the side menu to access the Multiview screen. The Multiview function makes it possible to combine multiple Inputs (up to a maximum of 4) in a single Output signal. The main screen is divided as follows: Source List Multiview 80028681_002_C –...
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.
User Interface 6.6.5 Audio control Press the icon on the side menu 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).
User Interface 6.6.5.1 Volume adjustment To adjust the volume of the microphones or line inputs, proceed as follows: Step Image Operate the volume bar of the microphones or line inputs based on the volume to be modified. Slide the bar to increase or decrease the volume of the microphones or line inputs.
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 the speaker volume. 80028681_002_C – 774259 – 2021-09-01...
User Interface 6.6.6 Surgical light management Press the icon on the side menu to access the management screen for the devices in the operating theatre. The main screen is divided into 2 sub-control areas respectively for the 2 operating lights installed in the operating theatre: Main Satellite The image shows the situation where the lamp control system...
User Interface In the image, you can see that the functions accessible from the touchscreen system are: – Light on/off; – Enable sync function (synchronisation of the 2 lights); – Adjust light brightness level; – Adjust light colour temperature; – Set focus (automatic function can also be activated)*; –...
User Interface “Lock with PIN” function The Helion Video Management System includes a Lock function for locking the touchscreen using a PIN. To lock the touchscreen, proceed as follows: Step Image Press to lock the screen. Enter the PIN code to unlock the touchscreen using the highlighted numeric keypad.
User Interface “Login” function The Helion Video Management System includes a Login/Logout function for managing user access. The Login function can be set as active by default at system startup or only following a Logout. The Login screen requires completion of 2 mandatory fields, Username and Password, in order to access the system.
Disposal instructions Disposal instructions Electrical equipment that is no longer in use must not be disposed of as normal communal waste. The substances and materials contained in them must be disposed of separately in an appropriate manner, so that they can be recycled for the production of new products.
Annex I - Getting started Annex I - Getting started Video Routing To send a video signal to a monitor, drag the relevant 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 in the relevant Monitor icon and updated periodically.
Annex I - Getting started 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 concerning the new patient (fields marked with a * are mandatory).
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