Lifelines neuro R40 User Manual Download Page 1

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USER MANUAL

EEG System

Summary of Contents for neuro R40

Page 1: ...USER MANUAL EEG System ...

Page 2: ...on Road Dun Laoghaire Dublin A96 F8W5 Ireland Doc No 51335 006 Part No 1338 Issue 2 1 CCN CCN0153 Created Checked Approved Digitally signed by Geoff Salter Date 2021 12 07 18 37 16 Z Digitally signed by David Hulin DN cn David Hulin o Lifelines Ltd ou Development email david hulin llines com c GB Date 2021 12 08 10 39 22 Z Digitally signed by Geoff Salter Date 2021 12 08 15 24 15 Z ...

Page 3: ... by or are available from Lifelines The owner of this system has the sole responsibility for any malfunction resulting from improper use or maintenance or repair done by anyone other than a qualified Lifelines representative and for any malfunctions caused by any parts that have been damaged or modified by anyone other than a qualified Lifelines Neuro representative The owner of this system has th...

Page 4: ... not recognise any other warranty either implied or in writing In addition services performed by someone other than Lifelines or its authorised agents or any technical modification or changes of products without Lifelines prior written consent may be cause for voiding this warranty Defective products or parts must be returned to Lifelines or its authorised agents along with an explanation of the f...

Page 5: ...stalled and put into service according to the EMC information provided in the Appendix Software and Virus Protection Lifelines takes all reasonable steps to ensure that its software is virus free In line with modern computing practice it is advisable that continual protection against viruses Trojans malware adware etc is provided on the PC used for installation and the surrounding systems Please n...

Page 6: ...nents 12 1 7 Replaceable parts 14 2 Installation and Maintenance 15 2 1 Checks for completeness and integrity 15 2 2 Environmental parameters for operation 15 2 3 Power supply connections 16 2 4 Use with other equipment 17 2 5 Interference 17 2 6 Maintenance and cleaning 18 2 7 Disposal of equipment 18 3 Connections and Usage 19 3 1 Overview 19 3 2 Connecting the R40 System 21 3 3 Starting the sys...

Page 7: ...control window 27 Figure 6 Hyperventilation 28 Figure 7 Hyperventilation control window 28 Figure 8 Bluetooth pairing 30 Figure 9 WiFi setup 31 Figure 10 Unsecure network error message 31 Figure 11 Bluetooth connection quality monitor 32 Appendices Appendix 1 R40 Amplifier Specifications 24 Appendix 2 Photic Stimulator and Hyperventilation 27 Appendix 3 Additional Events Information 29 Appendix 4 ...

Page 8: ...an Electrocap connector The R40 24 EEG Amplifier is a reduced channel variant of the R40 amplifier The R40 24 provides 24 referential channels and 4 polygraphic channels In all other respects the R40 24 amplifier is identical to the R40 The system includes a PC and monitor for control and storage powered by a medical grade power supply and an optional USB Photic Stimulator and arm The system is mo...

Page 9: ...Medical Device Directive 93 42 EEC in Europe or FDA cleared for use in USA The conductive part of electrodes and their connectors including the Neutral electrode should not contact other conductive parts including earth Lifelines does not supply the Nonin sensor Only use the PureLight sensors specified by Nonin to be used with their Oximeters The cart should be positioned in use so that disconnect...

Page 10: ...ose proximity to the R40 EEG System do not use mobile phones transmitters power transformers motors or other equipment that generates magnetic fields Refer to the Appendix for more information Before transportation the system should be put into its transportation position to reduce the risk of overbalancing disconnect mains supply cable lower work top to lowest position fully retract arms release ...

Page 11: ...ve 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 This includes batteries printed circuit boards electronic components wiring and other elements of electronic devices Follo...

Page 12: ...l and storage a video monitor a medical grade power supply and an optional USB Photic Stimulator and arm The system is mounted on a special wheeled cart which houses all components and allows convenient mobility The system uses a specific PC and medical grade power supply Refer section 3 1 for details The PC or laptop must only be powered using the medical grade mains power supply as supplied or a...

Page 13: ...1 M90 Canadian standard for medical electrical equipment general requirements IEC 60601 1 2 Standard for medical electrical equipment EMC requirements calling CISPR11 Conducted Emissions Group 1 Class B CISPR11 Radiated Emissions Group 1 Class B IEC61000 4 2 Electrostatic Discharges IEC61000 4 3 Immunity Radiated RF Field IEC61000 4 4 Immunity Transients Bursts IEC61000 4 5 Immunity Surges IEC6100...

Page 14: ...connector The Amplifier has built in type BF patient isolation and has a USB interface to the PC Optional wireless communication is available Bluetooth and WLAN WiFi The R40 24 EEG Amplifier is a reduced channel variant of the R40 amplifier The R40 24 provides 24 referential channels and 4 polygraphic channels In all other respects this amplifier is identical to the R40 Applied parts EEG Electrode...

Page 15: ...y 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 Only use the laptop and the medical grade power supply as supplied or authorised by Lifelines Do not use the standard laptop power supply The Setup and Recording Software The R40 Trackit setup software runs under Micro...

Page 16: ...en lid place the tool under the coin cell battery and without exerting any stress on the holder itself gently prise out the battery at the negative terminal end The battery should release from the battery holder 4 Remove the battery from the battery holder 5 Locate the replacement battery positive side up against the POSITIVE terminal of the battery holder 6 Gently push the battery at the negative...

Page 17: ...have been received 3 Assembly instructions for third party products will be found in their packing cases It is recommended that these instructions be filed with the R40 system technical reference materials 4 Check for signs of damage that may have occurred during transit or storage If any damage is found do not use the instrument contact your distributor 1 10 Environmental parameters for operation...

Page 18: ...Vac 0 7 A 230 Vac Output 20 Vdc 5 25 A The computer must only be connected to the medical grade laptop power supply supplied or authorised by Lifelines Do not use the standard computer power supply Only use the computer supplied or authorised by Lifelines 1 This equipment must only be connected to a supply mains with protective earth 2 Always use the power lead and connector supplied with the R40 ...

Page 19: ... via a medical grade power supply and any other equipment powered from another mains supply 1 13 Interference The R40 will continue to operate in the presence of radio frequency magnetic fields RF and the effects of electrostatic discharges ESD and other interference in accordance with the requirements of EN60601 1 2 However the R40 amplifier records signals of very low amplitude and these signals...

Page 20: ...are recommended in order to prevent the ingress of any liquid into the equipment Suitable products include Mikrozid Sensitive Wipes Schülke Mayr GmbH Microbac forte Paul Hartmann AG Distel Wipes Tristel Ltd Mikro Kill disinfectant wipes Medline Industries Inc Sani Cloth HB Germicidal Wipes PD International Inc For cleaning instructions for the computer refer to the manufacturer s documentation Do ...

Page 21: ...Patient Isolation Zone R40 Amplifier To USB Ports EEG Electrodes Patient All in one PC Optional Photic Stimulator and arm System Cart 1 R40 mounted on bracket or flexible arm 2 Lever for height adjustable cart worktop 3 All in one PC 4 VESA mount 5 Photic mounted on medirail and flexible arm Figure 1 Connecting the R40 System Connections and Usage 5 3 4 1 2 ...

Page 22: ...he laptop supplied or authorised by Lifelines The Cart Arm and Stand This allows all the system components to be conveniently located on a custom cart This cart has a height adjustable worktop large lockable wheels a medirail VESA display mount and an accessory tray NOTE The cart is supplied flat packed refer to the enclosed instructions for assembly details A single mains input cable to the cart ...

Page 23: ...ads fitted with DIN 42802 connectors Also on the front face of the Amplifier are the electrode impedance check set level pushbuttons Adjacent to each electrode is an LED indicating whether the impedance of the individual electrode is above the set level The Amplifier accepts standard 1 5 mm touchproof electrodes using DIN 42802 style connectors To ensure patient safety the electrodes used must be ...

Page 24: ...e Type BF isolated The conductive part of connectors and transducers should not contact other conductive parts including earth Always ensure that the transducer fitted is suitable for a connection of this type 2 3 Starting the system To start the system proceed as follows y Plug the PC into the mains supply y Switch on the PC and wait for Windows to load y Ensure R40 Amplifier is connected via the...

Page 25: ...D After connecting the Amplifier to the PC for the first time at the Windows prompt browse to the folder CD Drive USB Drivers From there Windows will find the correct drivers for the version of Windows being used The software has the following functions y Define signal types create labels to attach to inputs y Attach the desired signal type label to the recording input y Create a recording montage...

Page 26: ...t bias current 0 3 nA Front end Calibration 8mVpp 5 at 0 98Hz Impedance Check current 24nA 20 at 7 8Hz Polygraphy inputs Number of polygraphy inputs R40 8 bipolar touchproof inputs R40 24 4 bipolar touchproof inputs ADC Resolution 24 bits Sampling 250 16000 Hz Input impedance 20 Mohms Common mode rejection ratio 100dB 50 and 60 Hz Equivalent input noise 1 5µVpp 0 2µV rms Gain 12 0 5 AC 4 0 5 DC Ma...

Page 27: ...g Size 17cm x 11cm x 4cm Safety and EMC standards The system has been certified and complies with the following standards IEC 60601 1 and IEC 60601 2 26 International standard for medical electrical equipment general requirements and particular requirements for EEG systems ANSI AAMI ES 60601 1 AAMI Deviations from IEC 60601 1 USA CAN CSA 22 2 No 601 1 M90 Canadian standard for medical electrical e...

Page 28: ...with oxygen or nitrous oxide Not suitable Medical Grade Power Supply Specifications Input 90 264 VAC 47 63 Hz 1 4 A 115 Vac 0 7 A 230 Vac Output 20VDC 5 25A Power Rating 105W Dielectric Strength 5kV Earth Leakage Current 200uA Safety and Regulatory Approvals IEC EN60601 1 IEC EN60601 1 2 Size 147 x 75 x 39 mm Weight 1 5 kg Lenovo ThinkCentre All in One PC Specifications Safety and Regulatory Stand...

Page 29: ...d specifications please refer to the separate documentation Lifelines Photic User Manual and the Trackit Plus Software manual Figure 4 Photic Stimulation using Trackit Plus software Click on the Photic Stimulation icon in the top toolbar to bring up the Photic Stimulation control panel shown right This window allows single manual sweep and complex sequences of Photic stimulation to be produced Pho...

Page 30: ...ikewise HV Start will not work if Post HV is in progress This provides a digital timer which is used as follows y Click on HV Start to start the HV period and the timer starts running An HV Start event is recorded y Thereafter an HV event is automatically generated every 10 seconds y Click on Post HV Start to start the post HV period A Post HV Start event is recorded y Thereafter a Post HV event i...

Page 31: ...de Fixed Auto 10 Calibrate Mode Fixed Auto 11 Normal Mode Fixed Auto 12 Electrodes On Fixed Auto 13 Electrodes Off Fixed Auto 14 Patient Event Fixed Auto 15 External Event Fixed Auto 1 16 Awake User config 16x16 256 F1 17 Asleep User config F2 18 Eyes open User config F3 19 Eyes closed User config F4 20 Lights on User config F5 21 Lights off User config F6 22 Drowsy User config F7 23 User config F...

Page 32: ...s refer below Bluetooth is a device to computer wireless connection and will connect to any suitably certified Bluetooth host like a PC or laptop The connection process uses authentication and password protection The WiFi wireless LAN Module is a device to network wireless connection and will connect to a designated network via a Wireless Access Point WAP The connection process uses authentication...

Page 33: ...with its password as shown below Figure 9 WiFi setup If an attempt is made to connect to an unsecure network without a password this is prevented and an error displayed as shown below For maximum security it is recommended that only WPA2 access is allowed Figure 10 Unsecure network error message Appendix 4 ...

Page 34: ...e limit of the transmission range or when either antenna is adversely obscured or under the influence of interference It will be noticed that the wireless transmission will use its available bandwidth to try to catch up after a drop in signal quality and the indication can read more than 100 momentarily A reading therefore of less than 100 does not necessarily mean a permanent bad connection since...

Page 35: ...ult in interference issues FHSS devices and DSSS devices perceive each other as noise Both Bluetooth and WiFi technologies however use sophisticated error detection and error correction techniques to deliver correct data Additionally if a transmission cannot be decoded due to interference the transmission is resent This interference will of course increase as the number of coexistent devices in pr...

Page 36: ...ents of the wireless link and the fact that the R40 Interface Protocol is proprietary 4 The medical system uses mature industry standard hardware and protocols Bluetooth and WiFi This ensures that the system utilises all the benefits associated with these mature standards concerning the authentication data integrity and interference performance as discussed in this document 5 The radio modules are...

Page 37: ...EN 301 489 1 EN 301 489 17 EN 61000 6 2 y Health and safety EN 62479 EN 60950 1 IEC 60950 1 y Medical Electrical Equipment IEC 60601 1 2 y Bluetooth Qualification v4 0 WiFi Module Specifications y Type 2 4 GHz IEEE Std 802 11 b g Wireless LAN Module y Output power 12dBm max y Output frequency 2 412 to 2 462 GHz ISM band y Data rate 230kbps max y Protocols TCP UDP DHCP DNS ICMP ARP HTTP Client and ...

Page 38: ...than 30 cm 12 inches to any part of the Trackit R40 including cables specified by Lifelines Ltd Otherwise degradation of the performance of this equipment could result When in close proximity to the amplifier do not use mobile phones transmitters power transformers motors or other equipment that generates magnetic fields Refer to the Appendix for more information When using the amplifier in close ...

Page 39: ...the Recording setup have the same sample rate The R40 does not support multi sample rate An incorrect setup has been sent If an incompatible setup has been sent to the R40 the message unable to comply will indicate that If an incorrect setup has been sent the Trackit Control Panel will show Acquire Ready No The card is not formatted correctly If the card is not formatted with a correct 32 bit FAT ...

Page 40: ...d use is necessary the equipment or system should be observed to verify normal operation in the configuration in which it will be used 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...

Page 41: ... assure that it is used in such an environment Immunity Test EN 60601 1 2 Test Level Compliance Level Electromagnetic Environment Guidance Electrostatic discharges ESD IEC 61000 4 2 8 kV Contact 15kV Air 8 kV Contact 8kV Air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 While in use the patient should be sta...

Page 42: ...sorption and reflection from structures objects and people a Field strength from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be...

Page 43: ...ny risks to the patient as the R40 is a non invasive recording device that does not modify or interact with the patient Rated maximum output power of transmitter Separation distance according to frequency of transmitter W 150 kHz to 80 MHz d 1 17 P 80 MHz to 800 MHz d 1 17 P 800 MHz to 2 5 GHz d 2 33 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitter...

Page 44: ...d for use in USA to EEG electrode warning on page 8 y Amended Indications for Use statement on page 8 and deleted Intended Use y Added Compliance is provided by the recommended PC equipment to Electromagnetic Immunity tables in Appendix 5 y Changed EN references to IEC y Amended sampling rate and bandwidth specifications y Electromagnetic immunity compliance level amended on pages 39 40 V1 9 27th ...

Page 45: ...EEG Amplifier Lifelines Ltd 1 Tannery House Tannery Lane Woking Surrey GU23 7EF UK Telephone 44 0 1483 224 245 www lifelinesneuro com sales lifelinesneuro com ...

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