Related Manuals for baxter Helion
Summary of Contents for baxter Helion
- Page 1 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-AU...
- Page 2 This page is intentionally left blank.
- Page 3 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 80028686_051_F – 774296 – 2024-05-28...
- Page 4 Helion Optional sales items for the Helion video management system. Not all products are available in all countries. Product designation Helion Rack (115V) AC500920K Helion Rack (230V) AC500920K-2 Helion Rack (115V) - Permanent Install. AC500920K-3 Auxiliary Rack (115V) - Plug&Play Install.
- 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 any purpose other than the buyer’s personal use, without the express written permission of the manufacturer.
- Page 6 Helion This page is intentionally left blank. 80028686_051_F – 774296 – 2024-05-28...
-
Page 7: Table Of Contents
Combination with other Baxter products ........ - Page 8 Contents ‘Video Routing’ function ............40 5.3.1 Live Preview .
-
Page 9: General Preliminary Information
General preliminary information General preliminary information Operator’s responsibility The instructions for use of the Helion Video Management System are intended for operators trained and authorised in its operation. The management of the medical site is responsible for training staff in the use of the medical device. -
Page 10: Personnel Qualifications
User A suitably trained person who, thanks to their professional qualification, is authorised to operate and use the Helion Video Management System for as required. They are responsible for correct and safe operation of the system and for ensuring that it is used solely for the intended purpose. - Page 11 General preliminary information Symbol Description Symbol used to indicate the date of manufacture. Symbol used to identify the manufacturer’s name. Crossed-out bin: this product must not be disposed of as communal mixed waste, collect separately. Symbol used to indicate the Videomed S.r.l. material number. Symbol used to indicate the serial number.
-
Page 12: Product Certification
General preliminary information Product certification The Helion Video Management System is a Class I medical device according to Regulation 2017/745/EU on medical devices, and is compliant with the version of the regulation currently in force at the time of sale of the product. Videomed S.r.l. declares that... -
Page 13: Safety Information
DANGER ELECTRIC SHOCK FROM INCORRECT POWER CONNECTION PROCEDURE! The Helion system must be powered and earthed from the same electrical panel that powers the operating theatre. All equipment connected to the Helion system must also be powered and earthed from the same electrical panel that powers the operating theatre. -
Page 14: Security Considerations
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. CAUTION It is absolutely forbidden to remove the device labels and/or replace them with other labels. - Page 15 Updates and patches: – Updates and patches should be installed by a trained service technician authorised by Baxter following the installation directions. – Do not initiate an update during product usage. – It is recommended not to install any service packs or updates related to the operating system that are not required for the product to operate.
-
Page 16: Privacy Considerations
Privacy features in the product: The Product has features that help protect patient data. – Local storage: Data is only temporarily stored on the Helion system, which is hosted on-premises at the customer’s facility and is then transferred to the customer’s system and servers. - Page 17 Safety information – User authentication: To ensure that only authorised users can access patient data, it is necessary to enable user authentication for the product. The Authentication Application is designed to authenticate authorised users only by requiring them to prove their identity through a secure web application. The system also maintains a record of user activity and permissions to ensure compliance with regulations and policies.
-
Page 18: Useful Life Of The System
• Apply liquid to the cleaning cloth. NOTICE Risk of material damage Do not clean the Helion unit’s rear connector panel, or any of its connectors or buttons. This may cause damage to the connectors, buttons, and internal electronics. • Call Baxter service. -
Page 19: Cleaning Agents
Safety information 2.5.1 Cleaning agents When selecting the cleaning agents, ensure that they do not contain any of the following components: – organic, mineral, and oxidising acids; – bases; – organic solvents (e.g., ether, ketones, benzines); – halogens (chlorine, iodine, bromine); –... -
Page 20: System Description
– In the offices of physicians in private practice and other operating theatre-like environments, when the video conference function is used. – Note: If Helion is placed on a boom shelf, maintain a distance of 1.5 m or more to the surgical area during surgery. Normal use –... -
Page 21: Contraindications
System description – Information is exchanged by video conference with the operating theatre by sharing high resolution images and videos with the world outside the room. – The MD is regularly maintained by qualified service technicians in accordance with the defined maintenance intervals. –... -
Page 22: Use In Combination With Other Devices
(in combination with Trulight) 3.10.2 Combination with products of other manufacturers The Helion Video Management System can be used in combination with devices from other manufacturers. Only install devices in the patient environment that have been approved in accordance with standard IEC 60601-1. -
Page 23: Obligations And Prohibitions
System description It is also possible to use a medical FHD Touch screen Monitor that is not included in the catalogue. Please contact Technical Customer Service (www.hillrom.com) for compatibility information. 3.11 Obligations and prohibitions The management of the medical site is responsible for training staff on the use of the medical device. - Page 24 System description Main unit – Technical Specs Environmental Operating temperature: +10/+40°C conditions Operating relative humidity range: 30% to 75% Operating atmospheric pressure range: 54.0 kPa to 106.0 kPa Storage temperature: -40/+70°C Storage relative humidity range: 10% to 100%, including condensation Storage atmospheric pressure range: 50.0 kPa to 106.0 kPa Max.
- Page 25 System description Conference Unit – Technical Specs Protection Short circuit protection Overload protection Overcurrent protection Overvoltage protection Insulation voltage Input / output 4,000 V AC Input / FG 1500 V AC Environmental Operating temperature: +10/+40°C conditions Operating relative humidity range: 30% to 75% Operating atmospheric pressure range: 54.0 kPa to 106.0 kPa Storage temperature: -40/+70°C Storage relative humidity range: 10% to 100%, including...
- Page 26 System description 4K Unit – Technical Specs Environmental Operating temperature: +10/+40°C conditions Operating relative humidity range: 30% to 75% Operating atmospheric pressure range: 54.0 kPa to 106.0 kPa Storage temperature: -40/+70°C Storage relative humidity range: 10% to 100%, including condensation Storage atmospheric pressure range: 50.0 kPa to 106.0 kPa Max.
- Page 27 System description Rack Unit (optional) – 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...
-
Page 28: Measurement And Weight Layout
System description 3.13 Measurement and weight layout Main Unit Dimensions 133 x 430 x 450 mm Unit weight 13.5 kg Rack dimensions (optional) Rack brackets (optional) 80028686_051_F – 774296 – 2024-05-28... - Page 29 System description Conference Unit Dimensions 44 x 430 x 450 mm Unit weight 8 kg Rack dimensions (optional) Rack brackets (optional) 80028686_051_F – 774296 – 2024-05-28...
- Page 30 System description 4K Unit Dimensions 44 x 430 x 450 mm Unit weight 5.5 kg Rack dimensions (optional) Rack brackets (optional) 80028686_051_F – 774296 – 2024-05-28...
- Page 31 System description 4K Plus Unit Dimensions 44 x 430 x 450 mm Unit weight 5.5 kg Rack dimensions (optional) Rack brackets (optional) 80028686_051_F – 774296 – 2024-05-28...
- Page 32 System description Rack Unit Dimensions 800 x 600 x 757 mm Unit weight 64 kg Adjustable foot height 80028686_051_F – 774296 – 2024-05-28...
-
Page 33: System Components
System description 3.14 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. 4K Unit or 4K Plus Unit... -
Page 34: Conference Unit
Connection cables are supplied by Videomed S.r.l. 3.14.5 Control software The user interface of the Helion Video Management System allows each functional unit to be controlled and managed. A lower selection bar (always visible) allows the sections of the software to be uniquely identified based on the function performed. - Page 35 VIDEO CONFERENCE function. This function enables two-way audio/ video communication. The Helion Video Management System also ensures control and management of the main devices installed in the operating theatre: – PTZ Roomcam; – surgical lights with surgical video camera.
-
Page 36: Operation
Delivery of the Helion Video Management System is validated by a document signed by the operator. Once the system has been commissioned, the instructions included in this manual are binding for the user. -
Page 37: Connection To Sources
– CVBS (Composite) The technical drawing shows an example of the connection plates installed on the pendant panels. In case of Helion Video over IP configuration, Neutrik universal port connectors will be supplied and installed to connect video sources to Helion. -
Page 38: System Startup/Shutdown With Remote Button
Operation System startup/shutdown with 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. -
Page 39: User Interface
User interface User interface General description of the user interface The user interface is divided up as follows: Element Description STATUS BAR Contains important information such as the patient’s name and the number of recorded media related to them. Information such as the date and time and a dashboard showing the status of the recording, video conference, streaming and advanced modes ‘Privacy Mode’, ‘Do Not Disturb’... -
Page 40: Control Touch Screen
User interface Control touch screen The control screen is a high-resolution touch screen. 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: –... - Page 41 User interface 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] using drag&drop. The Preview of the video signal sent will be displayed in the relative monitor icon and updated periodically.
-
Page 42: Live Preview
User interface 5.3.1 Live Preview The Live Preview function can be used to enlarge or reduce the preview of the video signal of each connected source. To display the Live Preview of one of the signals available in the Source list, proceed as follows: Step Image Press the... - Page 43 User interface The following icons are present in the Live Preview window: Icon Function Starts/stops recording of the displayed signal. If the icon is greyed out, this indicates that the function is not active. To activate the function, select a patient from the list (refer to paragraph ‘Selecting a patient from the list’).
-
Page 44: Quick Access - Recording
User interface 5.3.2 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. -
Page 45: Quick Access - Streaming
User interface 5.3.3 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 appears with a white background in the Preview box of the selected source, and is disabled for the remaining... -
Page 46: Ptz Camera Control
User interface 5.3.4 PTZ camera control If activated on a controllable camera signal, the Live Preview function will allow access to its movement controls. 5.3.4.1 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). -
Page 47: Saving A Camera Setting (Preset)
User interface 5.3.4.3 Saving a 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 Give it a name and press confirm. The new named Preset will appear on the list on the side. -
Page 48: Deleting A Camera Setting (Preset)
User interface 5.3.4.4 Deleting a 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. 5.3.4.5 Enabling a camera setting (Preset) To activate a video camera Preset, proceed as follows: Step Image Press the desired Preset in the... -
Page 49: Recording' Function
User interface Step Image Press to confirm the Preset selection. ‘Recording’ function The Recording function enables capture snapshots and video recording from the signals connected to the system. This enables users to save images and videos to the system and then edit them. -
Page 50: Image Data Post-Processing
User interface The user may view and reproduce any material stored during the surgical activity (images and video) at any time by pressing the icon . In this way, a list will appear on the screen containing all previews of stored files, which can then be reproduced and processed using the functions described in the paragraph ‘Snapshot and video playback’. - Page 51 User interface Icon Function Starts/stops recording of the displayed signal. If the icon is greyed out, this indicates that the function is not active. To activate the function, select a patient from the list (refer to paragraph ‘Selecting a patient from the list’).
-
Page 52: Recording
User interface 5.4.3 Recording To record from the Recording function, proceed as follows: Step Image Press the icon of a Recording Channel to start recording a signal. When recording is in progress, the button is red in the selected Recording Channel. icon is also present in the upper part of the screen and also remains visible when... -
Page 53: Snapshot And Video Playback
User interface 5.4.4 Snapshot and video playback To play snapshots and videos, proceed as follows: Step Image Press and then simply press if the printing function is not enabled) to view all images and videos related to the selected patient. Press the icon to enlarge the selected media item. -
Page 54: Cutting Video
User interface 5.4.5 Cutting video To cut videos, proceed as follows: Step Image Press and then simply press if the printing function is not enabled) to view all images and videos related to the selected patient. Press the icon to enlarge the selected media item. -
Page 55: Export Images And Videos
User interface Step Image Once the cutting points are determined, extract the cropped video by pressing A new video appears in the photo/video list for the same patient. 5.4.6 Export images and videos Press and then (or simply press if the printing function is not enabled) to access the folder for exporting images and videos of the selected patient. - Page 56 User interface To export, proceed as follows: Step Image Select the export destination. This must be done in order for the images or videos to be exported. Press (on the right side of the screen) to send the files to the selected destinations. Pressing sends the files to the selected...
-
Page 57: Delete Images And Videos
User interface 5.4.7 Delete images and videos Press and then (or simply press if the printing function is not enabled) 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... -
Page 58: Printing Function
User interface 5.4.8 Printing function The Printing function enables users to print images of the selected patient directly from the Helion UI. Click on icon and then on icon to access the printing section. A screen with all the captured images is displayed, where you can select those you wish to print and the layout to be used. - Page 59 The web user experience may vary according to the browser used. This function is available only after the selected printer(s) has/have been installed and configured on Helion by qualified service personnel. 80028686_051_F – 774296 – 2024-05-28...
-
Page 60: Video Conference' Function
User interface ‘Video Conference’ function The Video Conference function enables 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; –... -
Page 61: Selecting The Signals To Be Sent By Video Conference
User interface source list; view of the two video conference channels. When the video conference is active, the dashboard receiver icon turns green 5.5.1 Selecting the signals to be sent by video conference From the Source List, drag the source you wish to send via video conference into the Primary Channel (or Secondary Channel) box. -
Page 62: Call Recipient Selection
User interface 5.5.3 Call recipient selection To select the call recipient, press the respective icon (depending on the mode) on the right side of the screen. The icons are described below: Icon Description Image Select a name from the contact list. Select a name/address from the calls sent/ received log. -
Page 63: Call Start
5.5.5 Call H.323/SIP recipient The following instructions outline the steps required to: – access the Helion system address book; – call into a H.323/SIP meeting via the Helion system. Step Image On a PC with Helion network access, open a modern web... -
Page 64: On Air Lamp
Note: You can mark a contact as a ‘Favourite’ to make it appear at the top of the list, in alphabetical order. Click Log into the Helion System user interface. Navigate to the Video Conference tab and review the saved contacts in the address... -
Page 65: Patient Data Management
Access the Audio setup screens. Access the management screen of the operating lights in the operating theatre. This function can only be used if the associated Baxter devices are present. Access the control screen of the lights in the operating theatre. -
Page 66: Selecting A Patient From The List
User interface 5.7.1.1 Selecting a patient from 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. 80028686_051_F – 774296 – 2024-05-28... -
Page 67: Entering A New Patient
User interface 5.7.1.2 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. -
Page 68: Entering An Emergency Patient
User interface 5.7.1.3 Entering an emergency patient If the conditions do not allow new patient data to be entered completely manually, this option can be used to quickly create a patient with the name Emergency Patient plus a random ID. In terms of available functionalities and management, emergency patients are similar to any patient entered manually or by calling up the Worklist. -
Page 69: Searching For A Patient From A List
Patients created as ‘Emergency Patient’ can be displayed only by applying the Emergency Patient Only filter: Step Image Select the icon at the top of the screen. Helion will then only display the list of emergency patients. 80028686_051_F – 774296 – 2024-05-28... -
Page 70: Modifying Patient Master Data
User interface 5.7.1.5 Modifying patient master data To modify a patient’s master data, proceed as follows: Step Image Search for and select the desired patient. Press to change the selected patient’s master data. This option is not available for patients in the Worklist section. 5.7.1.6 Deleting a patient To delete a patient’s master data, proceed as follows:... -
Page 71: Accessing The Worklist
5.7.1.7 Accessing the worklist If the Helion Video Management System is configured to connect to a centralised master data management system, the list of patients related to a given date/room/surgeon can be retrieved using the button. -
Page 72: Surgical Checklist
User interface 5.7.2 Surgical Checklist Press the icon on the side menu to access the Surgical Checklist screens. The Surgical Checklist is only activated after a patient has been selected. In section [A], you can go through the surgical procedure by following a sequence of questions and instructions on each stage of the procedure. -
Page 73: Preset
User interface 5.7.3 Preset Press the icon on the side menu to access the Preset screens. Presets are used to save room settings configurations. With Presets, you can recall the configurations by pressing the related icons. The main screen is divided as follows: Preset List 80028686_051_F –... -
Page 74: Setting Presets
User interface 5.7.3.1 Setting Presets 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 a name for the new Preset and add a description in the appropriate field below (optional). -
Page 75: Enabling Presets
User interface Step Image Press confirm. 5.7.3.2 Enabling Presets 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. -
Page 76: Multiview
User interface 5.7.4 Multiview Press the icon on the side menu to access the Multiview screen. The Multiview function combines multiple Inputs (up to a maximum of 4) into a single Output signal. The main screen is divided as follows: Source List Multiview 80028686_051_F –... -
Page 77: Multiview Setting
User interface 5.7.4.1 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 (up to 4 different Picture in Picture layouts) Drag the images (one at a time) from the Source List and drop them into the corresponding... -
Page 78: Audio Control
User interface 5.7.5 Audio control Press the icon on the side menu to access the Audio Control screen. In the Audio Control section, you can set the volume levels of the microphones and auxiliary lines. The ‘Microphones’ settings will affect the audio level recorded or sent to a remote location via Streaming or Video Conference (please note that Ambient Microphone only works for Video Conference). -
Page 79: Volume Adjustment
User interface 5.7.5.1 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. -
Page 80: Disabling Microphones And Audio
User interface 5.7.5.2 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. 80028686_051_F – 774296 – 2024-05-28... -
Page 81: Surgical Light Management
The screen below shows a case where the surgical lights control system cannot be reached. The Helion Video Management System provides the option of controlling the Baxter surgical operating lights (see chapter 3.10.1), using a reproduction of the light control console via the graphical interface. -
Page 82: Environmental Control Panel Management
The control panel management screen can only be used if there are Operamed devices in the operating theatre. The Helion Video Management System from Videomed S.r.l. only enables the association of Operamed control panels. 80028686_051_F – 774296 – 2024-05-28... -
Page 83: Lock With Pin' Function
User interface ‘Lock with PIN’ function The Helion Video Management System includes a Lock function for locking the touch screen using a PIN. To lock the touch screen, proceed as follows: Step Image Press to lock the screen. Enter the PIN code to unlock... -
Page 84: Login' Function
The Login screen requires the completion of 2 mandatory fields, Username and Password, in order to access the system. Once the correct credentials have been entered, the system will show the initial Helion graphical user interface (Video Routing interface). Press the icon to log out and be redirected to the credentials screen. -
Page 85: Electromagnetic Compatibility
The Helion product is a Class A electromedical device according to IEC 60601-1-2 (CISPR 11), which 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. - Page 86 Electromagnetic compatibility IMMUNITY test IEC test level Compliance Electromagnetic environment – guidance level Fast electrical ± 2 kV for power IEC 60601-1-2 The quality of the mains power supply should transients (burst) lines be typical for a commercial or hospital Test level environment.
-
Page 87: Disposal Instructions
Disposal instructions Test frequency Modulation Minimum IMMUNITY Applied IMMUNITY level (KHz) level (A / m) (A / m) 134.2 Pulse modulation: 2.1 kHz 13560 Pulse modulation: 50 kHz Disposal instructions Electrical equipment that is no longer in use must not be disposed of as normal communal waste. -
Page 88: Annex I - Getting Started
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 into one of the enabled monitors. The Preview of the video signal sent will be displayed in the relevant Monitor icon and updated periodically. - Page 89 Annex I – Getting started Selecting the signals to be recorded Drag the desired source into the Recording Channel box to enable basic recording functions: Recording start / stop Instant capture Press and then (or simply press if the printing function is not enabled) to close the patient record and export the files.
- Page 90 Annex I – Getting started This page is intentionally left blank. 80028686_051_F – 774296 – 2024-05-28...
- Page 91 This page is intentionally left blank.
- Page 92 80028686_051_F – 774296 – 2024-05-28...
Need help?
Do you have a question about the Helion and is the answer not in the manual?
Questions and answers