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USER

MANUAL

51331-006

Appendix 3: Manufacturer’s Declaration

EMC Compatibility

This section contains specific information regarding the device’s compliance with IEC 60601-1-2 and EN 60601-1-2.

The use of accessories, transducers and cables other than those specified, with the exception of

transducers and cables sold by the manufacturer of the equipment as replacement parts for internal

components, may result in increased emissions or decreased immunity of the equipment.

Medical electrical equipment needs special precautions regarding EMC and needs to be installed

and put into service according to the EMC information provided here.

The equipment or system should not be used adjacent to or stacked with other equipment and

that if adjacent or stacked 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 Photic Stimulator,

including cables specified by Lifelines Ltd. Otherwise, degradation of the performance of this

equipment could result.

Accessory name

Type

Length

Manufacturer

Photic USB Cable

Screened USB

Lifelines

Photic Trigger Output

Cable

Twin core

2.5 m

Lifelines

Appendix 3

Содержание 1240

Страница 1: ...USER MANUAL Imagine EEG Anywhere Stimulator ...

Страница 2: ...ywest Dublin D24 DKP4 Ireland No 51331 006 Part No 1240 Issue 2 0 CCN CCN126 Created Checked Approved Digitally signed by Geoff Salter Date 2020 04 22 10 44 48 01 00 Digitally signed by David Hulin DN cn David Hulin o Lifelines Ltd ou Development email david hulin llines com c GB Date 2020 06 15 14 25 49 01 00 Digitally signed by Geoff Salter Date 2020 06 15 14 30 36 01 00 ...

Страница 3: ...factured 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 representative The owner of this system has ...

Страница 4: ...e 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 failure Shippi...

Страница 5: ...alled 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 not...

Страница 6: ...ntal parameters for operation 12 2 3 Power supply connections 13 2 4 Use with other equipment 13 2 5 Interference 13 2 6 Maintenance and cleaning 14 2 7 Disposal of equipment 14 3 Connections for Photic Stimulator setup 15 3 1 Overview 15 3 2 Connecting the Photic Stimulator 16 3 3 Switching on 17 4 Photic Stimulator Setup Software 18 4 1 Installation 18 4 2 Overview 18 4 3 Manual Stimulation 20 4...

Страница 7: ...ulation 19 Figure 5 Photic connected and running Manual Stimulation 19 Figure 6 Sweep Stimulation 20 Figure 7 Sweep Stimulation setup 21 Figure 8 Complex Stimulation 22 Figure 10 Setup 1 23 Figure 11 Setup 2 25 Figure 11 Shutdown Procedure 26 Appendices Appendix 1 Photic Stimulator Specifications 27 Appendix 2 Connection Details 29 Appendix 3 Manufacturer s Declaration 31 ...

Страница 8: ...g testing Bystanders should be excluded from the treatment area Do not modify this equipment without the authorization of the manufacturer The use of accessories transducers and cables other than those specified with the exception of transducers and cables sold by the manufacturer of the equipment as replacement parts for internal components may result in increased emissions or decreased immunity ...

Страница 9: ...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 Follow all of your respective local laws and regulations for the proper disposal of such equipment Contact your local distributor for informatio...

Страница 10: ... Optional components Photic USB Splitter Cable 1243 Photic Ext Trig Cable Hirose connector 1242 Photic Pwr Ext Trig I P Cable D 26HD 1254 Photic Pwr Cntrl Ext Trig I P Cable D 26HD 1265 Photic Pwr Cntrl Ext Trig I O Cable D 26HD 1269 Photic D 26 BNC Adapter Cable 1260 Photic D 26 MiniDIN Adapter Cable 1270 Photic USB Trig Cable USB BNC 1261 Photic Trigger Output Cable Jack 1248 Photic Trigger Outp...

Страница 11: ...s Bursts IEC61000 4 5 Immunity Surges IEC61000 4 6 Immunity Conducted IEC61000 4 8 Immunity Power frequency fields IEC61000 4 11 Immunity Voltage dips interruptions IEC61000 3 2 Harmonic Emissions IEC61000 3 3 Voltage Fluctuations flicker Note Compliance is provided by the PC Classification Degree of protection against electrical shock No patient applied parts no accessible metalwork Type of prote...

Страница 12: ...and the luminous energy produced is not capable of creating a health hazard to the patient Note the Cautions at the beginning of this document Refer to Figure 1 for the system setup The Photic Stimulator is typically placed 30 cm in front of the patient s eyes The operator would normally stand in front of the patient in order to observe any physiological effects during the test Other persons are e...

Страница 13: ...he D 26HD trigger input to a standard BNC connector D 26HD MiniDIN Adapter This cable is used with the cable above to convert from the D 26HD trigger output to a MiniDIN connector Ext Trigger Input Cable Hirose HR212 10P 8P connector This cable allows the Photic to be supplied by 15V and triggered from the Viasys V32 system Ext Trigger Input Cable USB control USB and BNC connectors This cable allo...

Страница 14: ...ion to the requirements of IEC 60601 1 2 1 Checks for completeness and integrity 1 Remove the equipment from the packaging case s 2 Use the parts list to check that all ordered items 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 Photic Stimulator technical reference materials 4 Check ...

Страница 15: ...ed equipment The Photic Stimulator has no patient applied parts and so when used simultaneously with other patient connected equipment for example a cardiac pacemaker or other electrical stimulator it is unlikely that a safety hazard will arise However always consult the documentation supplied with the other patient connected equipment to ensure that all hazards warnings and cautions are considere...

Страница 16: ...fection of the equipment can be carried out by the use of QAC based disinfectants Wipes 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 Do not allow any liquid to enter the c...

Страница 17: ...lamp or suitable stand Trigger isolated output cable optional Photic Stimulator Ext trigger input USB cable optional Ext trigger input power Hirose cable optional USB power control D26 adapter D26 plug trig I O BNC trig input BNC trig input Hirose power and trig input MiniDin trig output USB power control To Trackit R40 Aux input Figure 1 Connecting the Photic Stimulator List of parts List of opti...

Страница 18: ...rameter is setup once over the USB interface and is then used thereafter at every switch on Refer to section 4 for details NOTE In V4 and later of the Photic firmware it is possible to setup an internal flash memory parameter to control the default intensity and duration including the PWM 12V case for external trigger inputs This parameter is setup once over the USB interface and is then used ther...

Страница 19: ...s a TTL type signal and is used to provide a synchronisation trigger output pulse to the PC 3 3 Switching on The Photic Stimulator has an on off switch located on its rear panel When off the flash output is stopped immediately The state of the switch is communicated back to the host PC if using a USB connection Connections for Photic Stimulator Setup ...

Страница 20: ...ses only and may not be exact representations of the actual product 4 1 Installation The USB drivers will be found on the installation CD Upon first connection of the Photic to the PC USB port 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 To install the main program follow the instructions in t...

Страница 21: ...hotic Off depending on the state of the On Off switch at the rear of the unit With no Photic connected or when no flash stimulation is in progress the Title Bar will display Photic Stimulator Stopped The status bar also shows the power source USB and the operating current in mA With a Photic connected and flash stimulation in progress the Title Bar displays Photic Stimulator Running as shown below...

Страница 22: ... and automatically adjusts the duration depending on the repeti tion rate At low frequencies the duration is lengthened and at high frequencies it is shortened according to the Duty Cycle set refer below for details If the Auto function is selected the Duration control is not accessible Single Flash Click on the button to produce a single flash Go Stop Click on the button to start stop the flash s...

Страница 23: ...the Reset button to start back at the beginning To set the parameters for the Sweep click on the Setup button Figure 7 Sweep Stimulation setup This allows the Start Frequency Stop Frequency and Dwell time to be set Click on the Set button to calculate the full sweep parameters and fill in the table The Flash Duration control will be available if Auto Duration has not been set as described above Cl...

Страница 24: ...a gap of defined length with no flash stimulation The list displays each step in the sequence with the current active step highlighted Select any step to start at or click on the Reset button to start back at the beginning Gaps are displayed as 0 Hz When the end of the Complex pattern is reached the program automatically reset back to the beginning To set the parameters for the Complex click on th...

Страница 25: ...finished setting up This will save the settings and revert to the control panel 4 6 Setup 1 Figure 10 Setup 1 The software version is displayed at the top The Always on top option sets whether the window is displayed always on top or not The minimise window op tion is of course operational in either mode Keyboard Shortcuts You can select which keyboard key will start and stop the Photic flashing N...

Страница 26: ...a linear relationship So if for example the duration is 8ms and using 1 USB port then the intensity is reduced as follows using a 10 8 multiplication factor y At 44Hz the maximum intensity is 6 y At 56Hz the maximum intensity is 5 This means that setting the duration to 6ms and using a single USB port the maximum intensity is maintained up to the maximum repetition rate Many host USB ports and pow...

Страница 27: ... extended status information to be displayed in the Status Bar Normally deselected Also here is the option to set the default flash intensity and duration when the unit is being triggered externally This is set once over the USB interface and stored inside the Photic unit s flash memory for use at every subsequent switch on Note that the duration parameter is over ridden in the PWM case as describ...

Страница 28: ...displayed to the left to confirm So for example to set Intensity 7 and Duration 10 the value to enter would be 112 10 122 NOTE This only works for Photic units fitted with firmware V3 or later The version is displayed at the top of the window NOTE For firmware V4 or later it is also possible to override the PWM input case when 12V is applied This is useful for situations where 12V is available not...

Страница 29: ...accuracy 2 5 Intensity control 7 steps linear control Flash duration control 1 10ms duration fixed or auto duty cycle 200ms max Internal accuracy 2 5 Power Input USB 5V 0 5A max 1 USB Port 5V 1A max 2 USB Ports 12V 15V 0 3A Connection to 3rd party EEG system Connections ports and controls I O Control RJ45 connector RJ45 Connector providing 1 USB data I O and power input 2 External power input 3 Ex...

Страница 30: ...0 4 6 Immunity Conducted IEC61000 4 8 Immunity Power frequency fields IEC61000 4 11 Immunity Voltage dips interruptions IEC61000 3 2 Harmonic Emissions IEC61000 3 3 Voltage Fluctuations flicker Note Compliance is provided by the PC Classification Degree of protection against electrical shock No patient applied parts no accessible metalwork Type of protection against electrical shock Note When unit...

Страница 31: ... recording The frequency and duration of the signal match that of the Photic stim Pin 7 USB DM signal Pin 8 USB DP signal Type 249 Touchproof Connector This connector provides an isolated signal suitable for connection to type BF equipment The signal is approximately 75mV in amplitude with a pulse width the same as the currently set flash duration It is normally connected to an Aux input on the Tr...

Страница 32: ...into MiniDIN output 6900 USB USB MiniDIN 1260 Photic D 26 BNC Adaptor Cable 2 5m Converts 1254 or 1265 or 1269 into BNC input 6892 USB USB USB or BNC 1248 Photic Keyhole Trig O P Cable 2 5m jack Provides a 75mV isolated tick mark for connection to Amp via 3 5mm jack plug 81000476 Jack 1251 Photic Keyhole Trig O P Cable 2 5m touchproof Provides a 75mV isolated tick mark for connection to Amp via to...

Страница 33: ...nd put into service according to the EMC information provided here The equipment or system should not be used adjacent to or stacked with other equipment and that if adjacent or stacked 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...

Страница 34: ...mmunity 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 15V Air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast Transients burst IEC 61000 4 4 Compliance is provided by the recommend...

Страница 35: ...nge applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption 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 accurac...

Страница 36: ...nt should move to an area without interference 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 transmitters rated at a maximum output power not listed above the recommended separa...

Страница 37: ...itional light output details in Specifications page 32 V1 7 20 July 2011 y Additional interface cables added sections 1 2 and 1 4 y Additional connector and cable details added in Appendix 2 y Clarification to Overview diagram in section 3 and section 3 2 y External trigger input amplitude and duration added to Specification V1 8 25 July 2012 y Various amendments for 60601 3rd edition V1 9 22 July...

Страница 38: ...Imagine EEG Anywhere Lifelines Ltd 7 Clarendon Court Over Wallop near Stockbridge Hampshire SO20 8HU UK Telephone 44 0 1264 782226 www LLines com sales LLines com Stimulator ...

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