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Related Manuals for Lifelines R40
Summary of Contents for Lifelines R40
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Page 2: Version History
R40 EEG System User Manual Version History V1.0 (24 June 2014) • Initial release V1.1 (7 July 2014) V1.2 (31 July 2014) V1.3 (18 September 2014) V1.4 (29 September 2014) • Various amendments for IEC 60601-1 3 edition • Amended Appendix 5 compliance levels. - Page 3 R40 EEG System User Manual Lifelines Ltd, 7 Clarendon Court, Over Wallop, near Stockbridge, Hampshire SO20 8HU, UK Telephone +44 (0)1264 782226 www.LLines.com sales@LLines.com Incereb Ltd. 3015 Lake Drive Citywest Dublin D24 DKP4 Ireland 2797 Doc No: 1338 Part No:...
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Page 4: Disclaimers & Warranties
The information in this section is subject to change without notice. Except as stated below, Lifelines Ltd makes no warranty of any kind with regard to this material, including, but not limited to, the implied warranties of merchantability and fitness for a particular purpose. Lifelines shall not be liable for errors contained herein or for incidental or consequential damages in connection with the furnish- ing, performance or use of this material. -
Page 5: Software And Virus Protection
R40 EEG System User Manual Software and Virus Protection Lifelines takes all reasonable steps to ensure that its software is virus-free. In line with modern computing prac- tice, it is advisable that continual protection against viruses, Trojans, malware, adware etc. is provided on the PC used for installation and the surrounding systems. -
Page 6: Table Of Contents
R40 EEG System User Manual Contents Version History Disclaimers & Warranties Trademarks Responsibility of manufacturer Software and Virus Protection Contents Illustrations System Overview and Technical Description General description Cautions and Warnings Explanation of symbols The system and its parts Specifications and safety... - Page 7 R40 EEG System User Manual Appendix 4: PC Setup Appendix 5: Manufacturer’s Declaration EMC Compatibility...
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Page 8: Illustrations
R40 EEG System User Manual Illustrations Figure 1 Connecting the R-40 System Figure 2 Connecting the R-40 Amplifier (top face) Figure 3 Connecting the R-40 Amplifier (front face) Figure 4: Trackit Software ‘File’ Toolbar Figure 5: Trackit Software ‘Home’ Toolbar Figure 6: Trackit Software "Settings Toolbar... -
Page 9: System Overview And Technical Description
CAUTION: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the R40 EEG System, including cables specified by Lifelines Ltd. Otherwise, degradation of the performance of this equipment could result. - Page 10 R40 EEG System User Manual CAUTION: Do not touch simultaneously any accessible USB or other contacts on the PC or monitor and the pa- tient. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
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Page 11: Explanation Of Symbols
R40 EEG System User Manual 1.3 Explanation of symbols Type BF equipment Follow operating instructions Input/output connection Input connection Special recycling required, do not dispose of in landfill. When this equipment has reached the end of its useful life, it must be disposed of in an environmentally-friendly way. Waste electrical and electronic equipment (WEEE) requires special procedures for recycling or disposal. -
Page 12: The System And Its Parts
Patient Event Pushbutton part number 1353 Note: The Oximeter sensor is a consumable and is not supplied by Lifelines. Only use the ‘PureLight’ sensors specified by Nonin for use with their Oximeters. Note: If using the Photic Stimulator refer to the User Manual supplied with it. -
Page 13: Description Of The Components
Where EEG studies are conducted within the patient environment the leakage current must be controlled. The PC power supply supplied by Lifelines is a special medical-grade type (with appropriate safety standards), which limits the mains leakage current of the system. It is rated for 90V – 230V input voltage. -
Page 14: Replaceable Parts
1.7 Replaceable parts Lifelines Ltd. will make available on request circuit diagrams, component part lists, descriptions, calibration in- structions, or other information that will assist service personnel to repair those parts that are designated by Lifelines Ltd. as repairable by service personnel. -
Page 15: Installation And Maintenance
R40 EEG System User Manual 2 Installation and Maintenance WARNING: The following section must be read and understood before the equipment is switched on. Note: Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the Appendix. -
Page 16: Use With Other Equipment
Caution: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the R40, including cables specified by Lifelines Ltd. Otherwise, degradation of the performance of this equipment could result. -
Page 17: Maintenance And Cleaning
R40 EEG System User Manual Note: Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the Appendix. 2.6 Maintenance and cleaning The R-40 System requires no routine testing, calibration or maintenance procedures apart from occasional cleaning and checking for wear and damage to all parts including the accessories. -
Page 18: Connections And Usage
R40 EEG System User Manual 3 Connections and usage 3.1 Overview Mains power Medical grade PC power supply electrodes Optional Patient Photic All-in- Stimulator one PC and arm R-40 Amplifier Patient isolation ports zone Photic mounted on Arm R-40 Amplifier... -
Page 19: Connecting The R-40 System
The arm will mount on the cart and accommodates either the Photic or the R-40 on its bracket. The arm is also supplied with a desk-clamp which allows it to be mounted on any convenient flat surface. When the R40 EEG system is in operation, do not push the cart. Place the cart in the transportation position before moving it. -
Page 20: Figure 2 Connecting The R-40 Amplifier (Top Face)
R40 EEG System User Manual Figure 2 Connecting the R-40 Amplifier (top face) The USB Cable is plugged into the bottom housing of the R-40 Amplifier as shown above using the RJ45 plug and into any USB port on the PC. -
Page 21: Starting The System
R40 EEG System User Manual 3.3 Starting the system To start the system proceed as follows: • Plug the system into the mains supply. • Switch on the PC and wait for Windows to load. • Ensure R-40 Amplifier is connected. -
Page 22: Trackit Software - Setup And Recording Software
4 Trackit Software - setup and recording software 4.1 Overview The Trackit software is available on the included CD/USB disk or on the Lifelines FTP site. A readme file de- scribes installation. The Trackit Software version 2.8.0.0 (or later) supports the R40 EEG Amplifier. Check with your distributor or Lifelines if a newer version of software is available. -
Page 23: Trackit Control Panel
2: Software registration. 3: Trackit Software Version information 4: User manuals for various Trackit and Lifelines products. 4.2 Trackit Control Panel The Trackit Control Panel shows the status of the connected Trackit amplifier and provides quick access to the common functions (“Connect”, “Disconnect”, “Send Setup”... -
Page 24: Figure 8: Trackit Control Panel
Check that the R40 USB cable is connected properly. b. Select the “USB” checkbox. The name and serial number of the R40 will appear in the drop- down list. If multiple Trackit amplifiers are connected to the computer, this drop-down will list all the connected amplifier. - Page 25 These parameters are detailed below. Check Amplifier status The Control Panel can be used to check that the R40 is online and setup correctly. The “Trackit A” tab of the Control Panel gives you the following status information for the amplifier: Acquire –...
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Page 26: Defining Input Signals
4.3 Defining Input Signals Defining signals is usually done once only or very occasionally. The R40 Amplifier arrives with a default set of signals that should suffice for most applications, hence it may only necessary to add signal types for poly- graphic recordings (airflow, respiration etc.). -
Page 27: Setting Up The Inputs And Recording Channels
Setups are saved in a *.tsu file. If a new setup is being created, proceed as follows: 3 Under the “Amplifier Channels” tab, select the “R40/T4-68/T4-32” checkbox. This will update the channel list with the available channels on the Amplifier. -
Page 28: Figure 14: Setup Recording Dialog
R40 EEG System User Manual Figure 14: Setup Recording dialog The Lifelines’ EEG Amplifier range supports the following channels. (High Nonin Heart Pulse Trigger Light Sample Amplifier Poly Event level SaO2 Rate Wave input Sensor Counter T4-32 T4-64 • Non EEG channels include: Aux –... -
Page 29: Starting A Recording
R40 EEG System User Manual To calibrate a DC Poly input to reflect a required unit of scale for a given voltage input use the signal editor (see Section 4.3). Select the appropriate units, e.g. %, or mm Hg, and en- ter the Physical Signal Amplitude required to generate the Ampli- fier Input Voltage. -
Page 30: Figure 25: New Patient Dialog
R40 EEG System User Manual The following steps are the same for setting up an Ambulatory recording (stored on the SD card), PC recording (stored on the computer) or dual recording (PC and Ambulatory). 1. Click on “Patient Details” in the ‘Home’ Toolbar. -
Page 31: Recording Control Panel (Amplifier Recording)
R40 EEG System User Manual 5. The ”Open Setup” dialogue box will appear; select the Recording setup file (as described in Section 4.4) and click “Open”. To bypass this step and use the setup loaded on the Trackit Amplifier, close this dialog box by clicking the ‘X’... -
Page 32: Figure 19: Recording Control Panel
R40 EEG System User Manual Figure 19: Recording Control panel Default file names To make the recording file name the same as the patient name: 1 Choose ‘Options’ from the Settings toolbar. 2 Put a checkmark by “Default to Patient Name” option. -
Page 33: View Eeg Signal Traces
R40 EEG System User Manual Periodic: The Trackit Amplifier records for specified periods of time at a defined interval (e.g. for periods of 30 minutes, with a 45-minute interval): 1 Under Record Mode, choose Periodic. 2 Use the frequency and duration sliders to define the length of the recording period, and the interval between periods. -
Page 34: Calibration Check
R40 EEG System User Manual want the numeric value displayed under the label. This can be useful when for displaying units such as mmHg or degrees C. When a channel is under individual channel control the label is depicted in red. -
Page 35: Events
R40 EEG System User Manual Figure 23: Continuous Impedance Check 4.10 Events To view all recorded events in the recording online, click on the “Events List” icon in the Home toolbar. Events are displayed in the Event viewer (Figure 24) with a description and time. -
Page 36: Montage Editor
R40 EEG System User Manual 1 2 3 3 4 5 Key: 1 Opens the list of event types Icons 2-6 are not used. Figure 24: Event Viewer The event list allows the user not only to see when events took place, but to also view the data behind those events. -
Page 37: Reading An Eeg Recording
R40 EEG System User Manual To change an Active or Ref channel on the brain image; 1. Select the designed channel on the list (or add/ insert a new channel). 2. Click on the current Active or Ref signal on the brain (Active signal is coloured Red, Ref signal is coloured green), 3. -
Page 38: Advanced Settings
Trackit Defaults are checked. Defaults Tab 1 This menu item activates a control dialog that adjusts how the amplifier behaves during a recording. Most op- tions are not applicable to the R40. See Figure 26. -
Page 39: Figure 26: Defaults Tab 1
Idle Mode: Amplifier turns itself off after a defined period when connected to a PC. Record Mode: Not applicable on the R40 Trackit Address: sets the serial address of the amplifier. Not used on the R40. BU battery auto charge: enables fast-charging of the backup battery when the amplifier is connected to USB or USB power bank. -
Page 40: Figure 27: Defaults | Tab 2
(the current Setup remains). Note that the parameter above must also be checked to use this feature. • Disable auto-record after manual Trackit off. (Not supported on R40) When checked, this causes a poten- tial Auto-record situation to be cancelled whenever the amplifier is powered-off either from its own front- panel pushbutton or from the Host. - Page 41 Lifelines distributor. Note: The R40 does not support card formatting. The SD card should be formatted on a PC using the recom- mended SD card formatting software.
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Page 42: Appendix 1: Specifications
R40 EEG System User Manual Appendix 1: Specifications Note: Lifelines reserves the right to change product specifications at any time without notice. This is in-line with the company’s policy of continual product development. R-40 Amplifier Specifications EEG inputs Number of EEG channels... - Page 43 R40 EEG System User Manual Aux. high-level DC Inputs Number of Aux channels 2 (channels 39 and 40) ADC Resolution 24 bits Sampling 250 – 16000 Hz Input impedance 100 Kohms Gain 4 ±0.5% Max Input V 2.25Vpp diff Bandwidth (-3dB)
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Page 44: Lenovo Thinkcentre All-In-One Pc Specifications
EN55032/CISPR 32 and FCC Part 15 Class B EN55024/CISPR 24 EN61000-3-2 and EN61000-3-3 EN 62311 Input voltage 20VDC Power 90 W Size 385 x 539 x 251 mm Weight 6.8 kg Lifelines Photic Stimulator Refer to the Lifelines Photic Stimulator User Manual for specifications and operational details. -
Page 45: Appendix 2: Photic Stimulator And Hyperventilation
Appendix 2: Photic Stimulator and Hyperventilation Photic Stimulation An optional Lifelines Photic Stimulator is available which can be used with the R-40 to assess patient photosen- sitivity in EEG studies. For a detailed description of operation, connection and specifications please refer to the separate documentation “Lifelines Photic User Manual”. -
Page 46: Hyperventilation
R40 EEG System User Manual Hyperventilation A method of timing and marking a Hyperventilation and post-Hyperventilation activation sequence is provided. Figure 30 Hyperventilation Click on the Hyperventilation icon on the top toolbar to bring up the control window as shown below. -
Page 47: Appendix 3: Additional Events Information
R40 EEG System User Manual Appendix 3: Additional Events Information For the R-40 EEG system, events types are as shown below. • 56 Automatic events (hardware events, photic start/stop, video start/stop etc.) • 40 user-configurable events • Free-text events entered during acquisition Event List Event No. -
Page 48: Figure 32 User Events
R40 EEG System User Manual The user-configurable events are edited and setup before acquisition. These are automatically saved and re- stored by the program. For ease of entry during acquisition, 24 of these events are mapped to the keyboard F1- F8 keys, Shift F1 –... -
Page 49: Figure 34 Free-Text Event
R40 EEG System User Manual Figure 34 Free-text Event During playback, all the events are displayed for the file by clicking on the Events icon. Double-clicking on an event in the list jumps to that point in the recording. All the events are also displayed in their correct position in relation to the EEG along the bottom of the main window. -
Page 50: Figure 36 Options Tab 1
R40 EEG System User Manual Appendix 4: PC Setup Options | Tab 1 The Options panel Tab 1 contains general settings which are self-explanatory as shown below. Figure 36 Options Tab 1 Options | Tab 2 The second tab in Options is shown below. -
Page 51: Figure 38 Options Tab 3
R40 EEG System User Manual • Use File Length instead of EDF Length. This a playback feature and if ticked, the file length is used instead of the ‘Length’ parameter embedded in the BDF header. Due to the fact that the R-40’s memory card can be removed at any time, there can be a partial 1s data block at the end of the file and so the actual size may not be an exact multiple of 1s. - Page 52 30 cm (12 inches) to any part of the equipment, including cables specified by Lifelines Ltd. Otherwise, degradation of the performance of this equipment could result. WARNING: When in close proximity to the equipment, do not use mobile phones, transmitters, power...
- Page 53 R40 EEG System User Manual Guidance and Manufacturer’s Declaration Electromagnetic Emissions IEC 60601-1-2 / EN 60601-1-2 The R-40 is intended for use in the electromagnetic environment specified below. The customer or user of the R-40 should assure that it is used in such an environment.
- Page 54 The R40 EEG Amplifier does not contain magnetic components and is not susceptible to power frequency magnetic field interference. f The conditions of intended use justify lower immunity test levels. The hazards and risk analysis associated with these lower limits have...
- Page 55 If any electromagnetic interference is encountered, the patient and equipment should move to an area without interference. In any case, the electromagnetic interference does not pose any risks to the patient, as the R40 EEG amplifier is a non-invasive recording device that does not modify or interact with the patient.
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