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© Nous Imaging, Inc. 

   FIRMM

®

 Installation Guide - Siemens 

          Page 41 

320-00201-DO-05 

Revision 12       

   Released: 02/2022 

 

Title 

Definition 

Standard, 

Reference 

Number 

 

Manufacturer 

Indicates the medical device 

manufacturer, as defined in 

EU Directives 90/385/EEC, 

93/42/EEC, and 98/79/EC 

ISO 15223-1, 

5.1.1 

 

Signifies waste from 

electrical and 

electronic 

equipment 

Dispose of this equipment 

according to local regulations 

for electrical and electronic 

waste disposal 

WEEE 

Directive 

2012/19/EU 

 

 

Authorized 

Representative in 

the European 

Community

 

The name and address of the 

authorized representative in 

the European Community, 

adjacent to the symbol. 

ISO 15223-1-

5.1.2

 

 

Medical Device

 

Indicates the item is a medical 

device. 

ISO15223-

1:2021, 

Clause 5.7.7 

 

EU Certification 

Mark 

Indicates that the medical 

device can be sold on the 

European market  

MDD 

93/42/EEC 

Annex I 

Section 13, 

MDD 

93/42/EEC 

Article 17

 

 

13

 

Technical Support 

We want you to be happy with the FIRMM device. Please contact us with any questions or concerns, 

or if you encounter a serious incident, by email at: 

[email protected]

 or call: +1-844-NOUSIMG (+1-

844-668-7464). In addition, if you encounter a serious incident, please contact the competent 

authority in your country. 
 

 

Содержание FIRMM

Страница 1: ...FIRMM Installation Guide Siemens MAGNETOM Scanners CMC Medical Devices Drugs S L C Horacio Lengo n18 C P 29006 Málaga Spain ...

Страница 2: ...Installation Guide Siemens Page 2 320 00201 DO 05 Revision 12 Released 02 2022 Manufactured for Nous Imaging Inc 393 N Euclid Ave Suite 310 St Louis MO 63108 Customer Support 1 844 NOUSIMG 1 844 668 7464 Email support firmm io ...

Страница 3: ...Tablet Computer 20 9 1 Switch McAfee Embedded Control Software to Update Mode 21 9 2 Move Files from Siemens USB Key to Host Computer 25 9 3 Leave Update Mode 29 9 4 Always Send Mode of Installation 29 9 4 1 Enable Automatic Siemens Transfer 29 9 4 2 Windows Start Menu Shortcuts for Always Send Mode 30 9 4 3 Enable Always Send Mode at MRI Scanner Startup 32 9 5 Manual Transfer Mode of Installation...

Страница 4: ...al Support 1 844 NOUSIMG 1 844 668 7464 support firmm io For instructions on how to use the FIRMM system please see the FIRMM User Manual 2 Safety Considerations The following section contains the safety considerations associated with FIRMM use The user needs to become familiar with the following information in order to use FIRMM safely and effectively 2 1 Definitions WARNING WARNING Indicates a h...

Страница 5: ...creased electromagnetic immunity of this equipment and result in improper operation WARNING 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 FIRMM system including cables specified by the manufacturer Otherwise degradation of the performance of this equipment could result CAUTION...

Страница 6: ...P contact Nous Imaging technical support at 1 844 NOUSIMG 1 844 668 7464 for additional guidance before proceeding with the installation 4 Overview FIRMM is provided with the following hardware FIRMM Tablet Computer and Software USB drive containing Siemens Scanner Scripts has a S label on it Additional USB drive pre installed in dock port with a DO NOT REMOVE label on it FIRMM Desktop Cradle Powe...

Страница 7: ... DT 313 MD Tablet manual This switch is provided for convenience in the event that no open network jack is available Note you will need your Siemens local service password to complete the installation The general process for setting up FIRMM include A Setting up the FIRMM Desktop Cradle B Setting up the FIRMM Tablet Computer C Activating your FIRMM License if necessary D Interfacing the FIRMM syst...

Страница 8: ...operating normally WARNING Use of accessories transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation WARNING Portable RF communications equipment including peripherals such as antenna cables and external antennas s...

Страница 9: ...he power supply brick Insert the barrel plug connector into the rear of the FIRMM Desktop Cradle as shown below Insert the AC connector into a power outlet 100 240 V AC Note if your Siemens MRI scanner and Siemens MRI host computer is provided with uninterruptible backup AC Power it is important that the FIRMM tablet be connected to an uninterruptible backup AC source as well ...

Страница 10: ...ive already inserted in the lower USB port It is labeled not shown below with a small sticker that says DO NOT REMOVE It is only to be removed if advised by Nous Imaging service Note This USB drive maintains a copy of the routine FIRMM software monitoring that can be used to assist you if detailed analysis of your system operation becomes necessary No protected health information is stored on the ...

Страница 11: ...e protective plastic sleeve and the protective plastic screen shipping protector Remove the small rubber cradle connection plug on the bottom edge of the FIRMM Tablet Computer as shown below With the Desktop Cradle facing forward insert the FIRMM Tablet Computer as shown below taking care to align the connector and the guidance pins Note The FIRMM Tablet Computer is intended to be left in its Desk...

Страница 12: ...Installation Guide Siemens Page 12 320 00201 DO 05 Revision 12 Released 02 2022 Insert the right angle CAT 6 Ethernet Cable or other into the network interface jack on the upper right hand edge of the Tablet Computer as shown ...

Страница 13: ...eft edge of the FIRMM Tablet Computer displays Power Battery status see blue arrow in photo below The LED should be blinking blue indicating the internal battery is charging Turn on the FIRMM system by pushing and then quickly releasing the Power Button on the lower right hand edge of the FIRMM Tablet Computer ...

Страница 14: ...14 320 00201 DO 05 Revision 12 Released 02 2022 The power button location from your DT313T MD Medical Tablet Basic Operations Guide is shown below The FIRMM system will power up with the display shown below indicating it is awaiting data from the MRI scanner ...

Страница 15: ...r at the time you renew a subscription for the FIRMM application Your updated licenses are available by contacting FIRMM Technical Support at 1 844 668 7464 or emailing support firmm io The new license key may be loaded directly into the FIRMM software as follows From the Home or Settings tabs on FIRMM select the information icon the yellow i in the upper righthand corner to bring up the software ...

Страница 16: ...onnection point from the FIRMM Tablet Computer to the Siemens Host PC internal network The provided 5 port Ethernet switch will be inserted between the MARS in the equipment room and the MRI Host Computer in the control room Note It is important to shut down the Siemens MRI Host Computer and scanner using the System End Session and the MRI System Wall Interface prior to removing the original netwo...

Страница 17: ...t is now safe to turn off your computer 3 Press the blue System Off button on the MRI System Wall Interface to power off the scanner and the MRI Host Computer Note Your FIRMM network switch should be plugged directly into an always on wall outlet and not into a power strip or another AC source that might be inadvertently switched off If the network switch is powered off this will interrupt communi...

Страница 18: ...mputer internal network port and inserted into the provided 5 port Ethernet switch This cable leads to the Siemens Measurement and Reconstruction Subsystem MARS in the equipment room The provided straight ethernet cable is inserted between the provided 5 port Ethernet switch and the Siemens internal network connection on the MRI host computer The provided right angle Ethernet cable is inserted bet...

Страница 19: ...elow showing where the connection from the Siemens internal network is removed and replaced with a connection to the provided 5 port switch Two examples are shown below After connecting the MRI Host Computer MARS and FIRMM tablet to the network switch power the MRI Host Computer and scanner back on by pressing the blue System On button on the MRI System Wall Interface ...

Страница 20: ...ens MRI Scanner to the FIRMM Tablet Computer if ever required Note that under normal circumstances users will not need these shortcuts 2 Manually initiate image transfer for each patient For manual FIRMM activation and deactivation with each new patient registration Windows Start Menu shortcuts are provided to initiate and stop the transfers from the Siemens MRI Scanner to the FIRMM Tablet Compute...

Страница 21: ...o the Siemens host computer as an advanced user 9 1 Switch McAfee Embedded Control Software to Update Mode For Siemens MRI systems starting with software versions VE11C VB19A and VB20P the Siemens host uses McAfee Embedded Control Solidifier security software It is necessary to switch this Embedded Control software into UPDATE mode before installing the FIRMM Scanner Scripts and to return it to no...

Страница 22: ... Nous Imaging Inc FIRMM Installation Guide Siemens Page 22 320 00201 DO 05 Revision 12 Released 02 2022 Step B From the Local Service interface select Utilities ...

Страница 23: ... Nous Imaging Inc FIRMM Installation Guide Siemens Page 23 320 00201 DO 05 Revision 12 Released 02 2022 Step C From the Utilities interface select Escape to OS ...

Страница 24: ...s Page 24 320 00201 DO 05 Revision 12 Released 02 2022 Step D In the command menu select the NT Command Interpreter enter MREmbeddedControlGUI and click Go Select Enter Update Mode as shown below Select OK on the acknowledgement dialog if one appears ...

Страница 25: ...ted during the installation it is very important to re enable the Embedded Control software The Embedded Control software is an important part of your Siemens MRI scanner computer cybersecurity 9 2 Move Files from Siemens USB Key to Host Computer Insert the USB Key labeled S in one of the USB ports on the Siemens MRI Host Computer front panel Create a directory T FIRMM ...

Страница 26: ...e 26 320 00201 DO 05 Revision 12 Released 02 2022 On the MRI Host Computer open a file explorer from the Windows Start Menu by pressing Ctrl Esc and selecting the Computer option As shown below navigate to the T drive and right click to create a New Folder ...

Страница 27: ... Nous Imaging Inc FIRMM Installation Guide Siemens Page 27 320 00201 DO 05 Revision 12 Released 02 2022 Be certain to change the name of the folder to FIRMM ...

Страница 28: ...M Scanner Scripts files should be visible in the T FIRMM folder as shown below Some of these files will be used in the steps below Remove the Siemens USB key from the Siemens MRI host computer Note Users should remove the Siemens USB key from the Siemens MRI host computer when the files have been transferred correctly to the Siemens MRI host computer disk as described in the installation manual Le...

Страница 29: ... If you wish to not enable always send but set up shortcuts to initiate image transfer for each new patient go to step 9 5 9 4 Always Send Mode of Installation 9 4 1 Enable Automatic Siemens Transfer In the File Explorer in the T FIRMM folder right click on FIRMM_activate_always send bat and choose Open Note there are several batch files and it is important to pay careful attention to open FIRMM_a...

Страница 30: ...ts are provided for manual FIRMM activation and deactivation to initiate and stop the transfers from the Siemens MRI Scanner to the FIRMM Tablet Computer in case it is ever required Note Users will not need these shortcuts under normal circumstances On the Siemens MRI Host Computer open a file explorer from the Windows Start Menu by pressing Ctrl Esc and selecting Computer ...

Страница 31: ...ays send utility to create the shortcut in the Windows Start Menu If you encounter difficulty with dragging the shortcuts to the Windows Start Menu you can move them to the appropriate folder using the file explorer as described below On a Windows 7 system the FIRMM start always send and FIRMM stop always send shortcuts should be dragged manually to the folder AppData Microsoft Internet Explorer Q...

Страница 32: ...en the Windows Start Menu again and verify the FIRMM always send start and stop scripts are now displayed in the Windows Start Menu 9 4 3 Enable Always Send Mode at MRI Scanner Startup Copy the Z_FIRMM_always send_startup_shortcut from the T FIRMM directory to the Windows startup folder Right click and open the Windows Startup folder highlighted in the screenshot below ...

Страница 33: ...eleased 02 2022 The below screenshot shows the path to the folder if you need to navigate to the location using the Windows file explorer For reference the Z_FIRMM_always send_startup_shortcut should be placed in C Users meduser AppData Roaming Microsoft Windows Start Menu Programs Startup ...

Страница 34: ...enu shortcuts to manually initiate and manually stop the transfers from the Siemens MRI Scanner to the FIRMM Tablet Computer for each new patient registration These are generally not used but provide an alternative method to the always send mode of image transfer if it becomes necessary as mentioned in the beginning of Section 9 Note If always send is disabled at your site the shortcuts mentioned ...

Страница 35: ...ted with other research applications which use the real time image transfer mechanism please contact Nous Imaging technical support at 1 844 NOUSIMG 1 844 668 7464 for additional guidance before proceeding with the installation On the Siemens MRI Host Computer open a file explorer from the Windows Start Menu by pressing Ctrl escape and selecting Computer ...

Страница 36: ...e patient utility to create the shortcut in the Windows Start Menu If you encounter difficulty with dragging the shortcuts to the start menu you can move them to the appropriate folder using the file explorer tools as described below On a Windows 7 system the FIRMM start one patient and FIRMM stop one patient shortcuts should be dragged manually to the folder AppData Microsoft Internet Explorer Qu...

Страница 37: ...ot use the start and stop shortcuts and will rely on the normal operation in which the scanner automatically sends all its data to FIRMM These controls are provided in the event some unexpected circumstance arises and the operator wants to force FIRMM to start manually Once the operator uses the manual mode they must continue to operate FIRMM manually until the Siemens MRI scanner is rebooted and ...

Страница 38: ...confirm that it is connected as seen below Press any key to dismiss the window 3 To stop from the Start Menu right click on the FIRMM stop one patient icon or FIRMM stop always send if always send is enabled and select Open The Siemens MRI host computer will confirm via a command prompt window that sending has been disabled as seen below Press any key to dismiss the window ...

Страница 39: ...g The rear of the FIRMM Desktop Cradle provides an HDMI video output for the optionally licensed biofeedback display The interface to your in bore Audio Visual system depends on your specific third party system The FIRMM unit provides an HDMI to HDMI cable For reference the FIRMM patient feedback option has been tested with the following display modes Aspect Ratio Video Graphic Array Type Resoluti...

Страница 40: ...tified ISO 15223 1 5 1 7 Catalog model number Indicates the manufacturer s catalog number so that the medical device can be identified ISO 15223 1 5 1 6 Refer to instruction manual booklet Indicates the user must read the instructions for use ISO 7010 M002 MR Unsafe To identify an item which poses unacceptable risks to the patient medical staff or other persons within the MR environment IEC 62570 ...

Страница 41: ...he European Community The name and address of the authorized representative in the European Community adjacent to the symbol ISO 15223 1 5 1 2 Medical Device Indicates the item is a medical device ISO15223 1 2021 Clause 5 7 7 EU Certification Mark Indicates that the medical device can be sold on the European market MDD 93 42 EEC Annex I Section 13 MDD 93 42 EEC Article 17 13 Technical Support We w...

Страница 42: ...ost Computer press Ctrl Esc to open the start menu 4 From the start menu right click FIRMM start always send or FIRMM start one patient and select Open 5 On the FIRMM tablet select the Settings tab Set the motion threshold to 0 1mm 6 Initiate the BOLD fMRI sequence 7 On the FIRMM tablet select the fMRI tab and monitor the scan FIRMM Test Scan successfully completed FIRMM is working correctly Take ...

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