CereStim M96 - Blackrock Microsystems
Contents
1. CereStim M96 User Manual Blackrock Microsystems LLC 391 Chipeta Way Suite G Salt Lake City UT 84108 Tel 866 806 3692 www blackrockmicro com Blackrock Microsystems CereStim M96 User Manual Copyright 2012 Blackrock Micosystems LLC All rights reserved Copying or other reproduction of this document is prohibited without prior written consent of Blackrock Microsystems LLC Rev Draft 1 00 R Page 1 LB 0495 BLACKROCK ic STE Blackrock Microsystems CereStim M96 User Manual Table of Contents MN A EE E E T E AE E ATA E ET i Contraindications Warnings CAUTIONS cccccssecccsecccseccenecceececencesenecceeceeenecesenceeeneeeeeceeuecesenceseneeseneceseeceseueeseneeteneeeees i Regulatory COMPI IANCE ccsescccccsssseccccceesececcueessceesseseeeeesaaeseeeesseeeeeeeseaeseceesaaaeseceeseeaseceesauaeeceesseuseceesaeaseeeesuansecessagaeeeeses iii Electromagnetic Compatibility ccccccsssscccccssscccccseseeccccaeseceesaeeeceesseseeceesaeeseceesaessecesseensecesseensecessuauseeessaeaeeessugaeseeees iii SVS EST ei 9 1 ONS EEE EEE EE EE vil 1 System VEN Eee ie 1 TL PANE EEE ER EEE EE NN EE 1 1 2 Accessories NOt Included xc ccssatcnssassncacsdnnnawsgaaandwocasadevedureunaiacaasantsanesdantnanteeedadacious Error Bookmark not defined 2 ET U ES EE T E E E E A 2 AE SS eg ER EE EE nes 2 2 2 CereStim M96 Back PANG vicinsccsateusscasacetonrsssessacesdadacendtvatoasandansacbesundos Uedncenseuchecssd2. IEC 60950 for data processing equipment or IEC 60601 1 for electromedical equipment in order to reduce the risk of electrical shock All combinations of equipment must be in compliance with IEC 60601 1 1 systems requirements Anyone connecting additional equipment to the CereStim96 configures a medical system and therefore is responsible that the system complies with the requirements of the system standard IEC 60601 1 1 IEC 60950 approved Information Technology Equipment must be placed outside the patient environment The patient environment is defined as an area 1 5m 4 92 feet from the patient Rev 1 00 Re NE Page ii LB 0495 Blackrock Microsystems CereStim M96 User Manual e The following options are recommended if there is a need to remediate system leakage current e Redundant protective earth connection shall be made to either the medical device or the other equipment e The other equipment shall be powered from a medical grade IEC 60601 1 compliant separating transformer e Caution Federal law restricts this device to sale by or on the order of a physician Regulatory Compliance The CereStim M96 meets all requirements of the following regulatory standards as set by domestic and international regulatory agencies for Medical Electrical Equipment UL 60601 1 Medical Electrical Safety Standard USA CAN CSA C22 2 no 601 1 M90 Medical Electrical Safety Standard Canada CAN CSA C22 2 no 601 1 B 90 R2006 CAN CS
3. Unlock After entering the appropriate password click the Unlock button to gain Administrative Rights Lock After any settings are changed click the Lock button to store the changes and prevent other users from making adjustments to the settings Max Values Panel 2 Only users with Administrative Rights are able to make adjustments to the maximum allowable values for the Output Vmax Amplitude Phase Width Charge per Phase and Rev DRAFT 1 00 Re pe Page 12 LB 0495 Blackrock Microsystems CereStim M96 User Manual Frequency parameters When making changes to the Max Values administrative users must specify all max values in order for Stim Manager to accept the update Upon initial start up the default Max Values are as follows e Max Output Voltage 9 5V e Max Amplitude 215uA e Max Width 2000us e Max Charge per Phase 28 000pC e Max Frequency 100Hz Update New max values are stored by clicking the Update button This button is only available to users with administrative rights Read All users are able to read the existing Max Value settings by clicking the Read button regardless of administrative rights Change Password Panel 3 After unlocking Administrator Rights users can change an existing password to a new password by entering the old password into the Enter Old Password box entering the new password in the Enter New Password box and retyping the new password in the
4. and other connectors to minimize the likelihood of tripping or accidentally pulling on cables Damaged cables may result in failed ground connections Each component of the system must be plugged into a separate outlet i e CereStim M96 Stim Switch subcomponents of the data acquisition and any other accessory equipment Using a power strip may cause leakage currents to exceed acceptable limits Connecting equipment to and from the CereStim M96 may result in a summation of leakage currents that can lead to the patient receiving an electric shock It is highly recommended that automatic Microsoft updates be turned off on the PC connected to the CereStim M96 Updates that occur while the system is in use may interrupt stimulation and may not be compatible with the current version of the software It is highly recommended that active and normal scanning with Anti Virus Software be disabled on the PC connected to the CereStim M96 Anti Virus software scans may interrupt stimulation Do not connect to the internet while the system is in use Care should be used in selecting equipment for connection to the Monitor port as it could potentially transmit large voltage transients directly to the patient electrodes Devices connected to this port must be isolated from earth ground in compliance with IEC 60601 1 Risk of Electrical Shock Hazard Accessory equipment connected to the CereStim M96 must be certified according to the respective IEC standards i e
5. modified to balance the charge Electrode Array Panel 3 This panel allows the user to select the electrode channel for single stimulation Active and inactive channels are displayed in the Electrode Array Panel as follows Rev DRAFT 1 00 Re pe Page 7 LB 0495 Blackrock Microsystems CereStim M96 User Manual 1 2 Active Electrode Inactive Electrode Channel Channel Figure 3 7 Status of Manual Mode Electrode Channels Stimulation Panel 4 Single channel stimulation pulses are initiated by clicking the Stimulate button While stimulating the Status LED on the front panel of the CereStim M96 should light up indicating that stimulation is in progress Waveform List Panel 5 Single stimulation waveforms created in the Waveform Panel can be saved and stored in the Waveform List Panel Waveform stimulation parameters are stored in the Stimulation Waveforms Directory Directories are set in the Settings option of the Tools Menu Waveforms can be deleted from the list by selecting the waveform and clicking the amp button Log Panel 6 The Log Panel echoes commands sent from the Stim Manager Software to the CereStim M96 and provides the user with results from the Test Modules and Test Electrodes functions see sections 3 6 and 3 7 below Information stored in the Log Panel is written to the Report Window and can be saved ina TXT file format The Report Window is accessed from the Tools Menu 3 2 Stim Manager Program Mode
6. Program mode allows the user to create complex stimulation programs as well as repetitive cycles Set Stim Manager to Program Mode by selecting Program Ctrl P from the Tools Menu Stim Manager el xi File Mode Tools Help Program Sequence Program List Stimulation Waveforms Polarity Pulses Amp1 width Inter Amp 2 width 2 Freq Cerestim 96 Disconnected r Rev DRAFT 1 00 R LB 0495 BLAGK Page 8 Blackrock Microsystems CereStim M96 User Manual Program List Panel 1 The Program List Panel allows users to create and store stimulation sequences Modify Program amp This feature allows users to modify the parameters of already existing programs Add Program amp The Program Creator window is opened by selecting the Add Program button The Program Creator allows users to define a program sequence using a series of single stimulations groups and wait instructions 1 Stimulation Waveforms Program Sequence Polarity Pulses Amp1 Width1 Interphase Amp 2 Width 2 Frequency Stimulus Wait Instruction Group Definition v Waveform Begin Group Figure 3 9 Program Creator Stimulation Waveforms Panel A This panel allows users to add stimulation parameters to single configurations Up to 15 different stimulation configurations may be defined Parameter values are as follows Polarity Anodic or Cathodic Number of Pulses 1 255 bipha
7. be that of a typical commercial or hospital environment If the user of the CereStim M96 requires continued operation during power mains interruptions it is recommended that the CereStim M96 be powered from an uninterruptible power supply or a battery It may be necessary to position the CereStim M96 further from sources of power frequency magnetic fields or to install magnetic shielding The power frequency magnetic field should be measured in the intended installation location to assure that it is sufficiently low Guidance and Manufacturer s Declaration Electromagnetic Immunity The CereStim M96 is intended for use in the electromagnetic environment specified below The customer or the user of the CereStim M96 should assure that it is used in such an environment Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Rev 1 00 LB 0495 Page iv Blackrock Microsystems CereStim M96 User Manual Guidance and Manufacturer s Declaration Electromagnetic Immunity Portable and mobile RF communications equipment should be used no closer to any part of the CereStim M96 including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended Separation Distance Conducted RF 3V 3V d 1 2vP 150kHz to 80MHz IEC 61000 4 6 150kHz 80MHz 80 am 3V m Radiated RF 80 2500 MHz 3V m d 1 2VP 80MHz to 800MHz IE
8. either the Anodic or Cathodic phase of the biphasic pulse first The pulse figure in the Stim Manager Main Window indicates whether the pulse configuration is set to anodic first or cathodic first Number of Pulses 1 255 biphasic pulses are available for each Configuration ID Range of Interphase Delay 53 65 535 us Range of Amplitudes Phase I amp Phase Il 1 215 A Phase Width Phase I amp Phase Il 44 2 000 us Hz 8 100 Hz NOTE Stim Manager will only accept whole number values Clear Pulse parameters can be cleared from the Waveform Panel by selecting the button Save Pulse parameters can be saved fo the Waveform List Panel by selecting the button Once saved stimulation parameters can be recalled by selecting the waveform from the Waveform List Panel Pulse Figure This feature identifies each parameter of the stimulation pulse as the user moves the mouse over the corresponding parameter boxes The pulse figure also identifies whether the first phase of the selected stimulus from the Configuration ID Panel is anodic or cathodic ararnar u hr lr ut yr Cathodic First Anodic First Figure 3 6 Cathodic and Anodic Pulse Figures NOTE Stim Manager enforces balanced charge in the biphasic pulse configurations created by the user In the event that the user creates a pulse with an unbalanced charge the software will produce an error message notifying the user that the parameters of the biphasic pulse must be
9. evaluate the stimulation parameters The Test Electrodes function can be activated either from the Tools Menu of Stim Manager or by CTRL SHIFT E 3 8 Stim Manager File Menu Open Ctrl O Allows users to open previously saved configuration CFG files Save As Ctrl Shift S Allows users to save newly created configuration files Configuration files include all stimulation sequences added to the Program List Program Mode all single stimulation pulses added to Rev DRAFT 1 00 R LB 0495 BLACK Page 14 Blackrock Microsystems CereStim M96 User Manual the Waveform List Manual Mode and all information stored in the Log Window of the Report Report information is saved as a separate TXT file under the current date Import CMP File This feature has not been implemented in the current version of the CereStim M96 The import CMP file option is intended to provide users with the ability to import their own map files and is intended to be implemented in future revisions of the Stim Manager software Save Ctrl S Allows users to save any modifications to previously saved Configuration files Quit Exits Stim Manager 4 Device Care and Storage e Handle the CereStim M96 with care Do not drop or strike the device In the event that the device is dropped the CereStim M96 must be returned to Blackrock Microsystems for inspection and recalibration before the device can be used again See section 7 e Turn OFF the system
10. with any computer that has not been tested to the IEC 60950 standards e Only use the CereStim M96 with electrodes that are specifically designed for direct contact with brain tissue e The CereStim M96 must only be used by medically professionals and highly qualified personnel trained in the use of cortical stimulation This manual is to be used in support of device use by personnel who have received device training from Blackrock Microsystems e When in use the CereStim M96 must be attended at all times by medical professionals trained in cortical stimulation e The CereStim M96 should be cleaned by highly qualified personnel who are trained in techniques to prevent cross contamination and infection e Avoid trans thoracic stimulation e Do not change parameters while stimulation is in progress e The CereStim M96 stimulation parameters should only be used within the safe operating range of the specific electrode being used Rev 1 00 Page ii LB 0495 Be AGKRO Blackrock Microsystems CereStim M96 User Manual Use only the supplied CereStim M96 components i e External Power Supply Substitution of components not supplied by Blackrock Microsystems may affect system performance and patient Safety Disconnect the CereStim M96 Stimulation System before defibrillation The CereStim M96 is not defibrillator proof and should not be used concurrently with a defibrillator Do not use the CereStim M96 in the presence of flammable substanc
11. A C22 2 no 601 1 1 94 R1999 EN IEC 60601 1 Medical Electrical Safety of Medical Equipment International and Europe EN IEC 60601 1 2 Collateral Safety Standard for EMC Electromagnetic Compatibility The following tables document compliance levels and guidance from the IEC 60601 1 2 2007 Standard for the electromagnetic environment in which the CereStim M96 should be used Medical Electrical Equipment requires special precautions regarding EMC and should be installed and put into service according to the guidelines provided in the tables below Guidance and Manufacturer s Declaration Electromagnetic Emissions The CereStim M96 is intended for use in the electromagnetic environment specified below The customer or the user of the CereStim M96 should assure that it is used in such an environment The CereStim M96 uses RF energy only for its internal RF Emissions function Therefore its RF emissions are very low and CISPR 11 are not likely to cause any interference in nearby electronic equipment The CereStim M96 is suitable for use in all CISRP 11 establishments other than domestic establishments Harmonic and those directly connected to the public low voltage Emissions Not Applicable power supply network that supplies buildings used for IEC 61000 3 2 domestic purposes Voltage Fluctuations Not Applicable Rev 1 00 Page 111 LB 0495 Ba IGKROSK Blackrock Microsystems Flicker Emissions IEC 61000 3 3 CereSti
12. Antivirus and third party software and hardware Blackrock Microsystems manufactures hardware and software to be compatible with standard PC computers and operating software However Blackrock Microsystems assumes no responsibility for the use or reliability of its software or hardware with equipment that is not furnished by Blackrock Microsystems Microsoft Updates It is highly recommended that automatic Microsoft updates be deactivated on the PC prior to using the CereStim M96 Updates may interrupt stimulation while the system is in use and may not be compatible with the current version of the Stim Manager software 2 4 Hardware Setup The CereStim M96 and its subcomponents i e USB A B Cable and external power supply are all suitable for use within the patient environment However any IEC 60950 approved information technology equipment that is intended for use with the CereStim M96 System i e computer must be placed outside of the patient environment The patient environment is defined as an area 1 5 m 4 92 feet from the patient 2 4 1 CereStim M96 Connection to Electrodes For standard electrode connections connection to the CereStim M96 is as follows 2 4 1 1 Unpack all components of the CereStim M96 packaging 2 4 1 2 Turn on your IEC 60950 PC and load the Stim Manager Software included in packaging 2 4 1 3 Confirm that the CereStim M96 is turned off WARNING Always make sure that the CereStim M96 is turned o
13. C 61000 4 3 80 am d 2 3vP 800MHz to 2 5GHz Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol Modulation scheme can be 2 Hz or 1 kHz NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones Rev 1 00 Page vi Se Barackre Blackrock Microsystems CereStim M96 User Manual Guidance and Manufacturer s Declaration Electromagnetic Immunity 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 considered If the measured field strength in the location in which the CereStim M96 is used exceeds the applicable RF compliance level above the CereStim M96 should be observed to verify no
14. Confirm New Password box New passwords must not be more than 32 characters Change Password Click the Change Password button to apply changes to the password 3 5 Stim Manager Report The Stim Manager Report Window stores all information regarding stimulation sequences sent from the CereStim M96 during each session of Stim Manager R Stim Manager Report 2 X Researcher Pathology 2 20 2012 H Figure 3 12 Stim Manager Report Window Report Options 1 Open This option allows users to open and continue adding to previous report files Rev DRAFT 1 00 R LB 0495 BLACKI Page 13 Blackrock Microsystems CereStim M96 User Manual Save This option allows users to save information in the Report Window as a TXT file The files are saved in the Log File Directory as set in the Settings option of the Tools Menu Researcher Panel 2 This feature allows the user to record and save the name of the researcher conducting the test procedure Patient Panel 3 This panel allows the user to record and save identifying information for the patient including the patient s name and pathology as well as the date of the test procedure Comments Panel 3 This panel allows the user to record and save comments or observations noted during the test procedure Comments are stamped with the date and time the comment was added to the Log Window Log Window 4 This panel allows user to view all information regarding s
15. air or maintenance do not send any equipment back without a Return Merchandise Authorization Number An RMA number will be issued to you by a Blackrock representative If you need to obtain an RMA number you may contact a product support representative at 801 582 5533 or toll free at 866 806 3692 Once an RMA number has been issued it is important to safely pack the returned item for shipping back to Blackrock It is preferred that you save the original boxes and packing materials that your system arrived in for return shipment Please address the package as follows Blackrock Microsystems Inc ATTN RMA 391 Chipeta Way Suite G Salt Lake City UT 84108 USA Tel 801 582 5533 Rev DRAFT 1 00 R LB 0495 BLACK Page 16
16. ccccsscccccssseccessecccescccseneccseeseceseaecesseueeesseueceseueeeessuecessauseessaeeesseesessanseees 15 FERD TEPPE 16 Rev Draft 1 00 R Page 1 LB 0495 BLACKROCK Blackrock Microsystems CereStim M96 User Manual Indications for Use The CereStim M96 is intended for use in functional brain mapping procedures during treatment of patients with seizure disorder Contraindications Warnings and Cautions IEC60101 0102 Danger of Electrostatic Discharge ESD IEC 348 Consult instructions for use IS07000 0434 Attention consult accompanying documents E IEC606417 5335 Type BF Applied Part L IEC60417 5172 Class II Equipment EN 980 Combined Manufacturer Manufacturing Date Eg EN EN 980 Serial Number Warnings and Cautions e The CereStim M96 should not be used on any patient whom the physician surgeon considers at elevated risk of infection e The CereStim M96 should not be used in chronic applications The CereStim M96 is intended for acute lt 30 days operation only e Electrocautery should not be performed while the CereStim M96 is in use e The CereStim M96 should not be used if the device has been dropped Dropping the device may cause damage to internal components that affect system performance and patient safety A dropped device must be returned to Blackrock Microsystems for inspection and recalibration before it can be used again See Section 6 and 7 of the CereStim M96 User Manual e The CereStim M96 should not be used
17. ed from the Tools Menu 3 3 Stim Manager Settings The Settings Window is located in the Tools Menu of Stim Manager and allows the user to enable disable available current modules change the maximum output voltage of the CereStim M96 and modify the directories for the Configuration Log Program and Stimulation Waveform files The Stim Manager Settings 2 x Current Modules PRPEGERR PEPE EEEEE Directories Configuration Files C Documents Configuration Files Log Files C Documents Log Files Program Files C Documents Program Files Stimulation Waveforms C Documents Stimulation Waveforms a e lesan Figure 3 10 Stim Manager Settings Window Stim Manager Settings Window is shown in Figure 3 10 to the right Rev DRAFT 1 00 R BLACK LB 0495 Page 11 Blackrock Microsystems CereStim M96 User Manual Current Modules Panel 1 Once the CereStim M96 has been connected and recognized by the Stim Manager Software the available current modules will appear in the Current Modules Panel Unavailable current modules are identified by a greyed out number Active current modules can be disabled by clicking the number of the current module to be deactivated T Fr g Unavailable Enabled Disabled Output Voltage Panel 2 This feature is unavailable on the CereStim M96 Directories Panel 3 This panel allows users to modify the locations in which the Configuration Log Program a
18. edeesasiwbnndeadedacuatvahadesamaessatunbeweres 3 2 TN 4 2 3 1 System Configuration Disclaimers Jar 4 GT NR 4 2 4 1 CereStim M96 Connection to the Stim SwitCh rrrnnnnnrnnnnnrrnnnnnrrnnnnnrnnnnnnre Error Bookmark not defined 2 4 2 CereStim M96 Connection to Electrodes rrrrrurrnnnnrnnnnrrnnnrrnnnnrnnnnrnnnnrnnnnsrnnnnrnnnnennnnennnnsnnnnnnnnnnennnnsnnnnsennenee 4 3 Stim Manager NN Es capannone EENE EEES 6 SM NTE 6 3 2 Stim Manager Program Mode rrronnnnnnnnnrnnnnnnrnrnnnrrnnnnnrnnnnnsrnnnnnsennnnernnnnssrnnnnesnnnnnssnnnnssnnnnnesnnnnnsrnnnnssnnnnnesnnnnssennnneeee 8 33 SN MT SNE GS 11 3 4 Administrator Setting Sesser narr Ean E NEARNE EEA EE SEEEN EENEN EE EAE E 12 3 5 Stim Manager Report rrrnnnrnnnnrnnurnnnnnnnnrnnnnrnnnrnnnennnnrnnnennnsnnnnennnsnnnannnnsnnnsnnnsnnnnennnsnnnsnnnnennnsnnnsnnnnnnnnsnnnsnnnevnnnsnnneenn 13 TN 14 TENNE 14 36 NNN 14 3 9 Application Programming Interface APl rrrrrnnnnnnnnnnnnrrrnnnnnnnnnrnrvrnnnnnnnnnnrrrnnrnnnn Error Bookmark not defined 4 DEVICE Care and Storage sa diivccicectscscscsisenaveianacracniaiaeasidsterecessesrecrtsansnssisaateusastarswiseuavenddeasesvinenbeauadaurnexianeanenseuees 15 5 Tou ISSA OCD ae 4vvrvrvrvrvrvr4v4v4vrvrvrjrvr EET TTT 15 6 NTN eE E EEE semis am aviavie get wsesiousieusana vn eudueussausnueabeseuwertnecsneswesinwasweunueeseecss 15 7 Return VIEFENANGISE AULTNONIZATION sede savevasccpsenesenevevasestennesssiwavannssunseatuvenvernch Gees 16 List of Fi
19. eration of the CereStim M96 Current Modules using an oscilloscope or other monitoring device The pinout for this connector is shown in Figure 2 3 above Numbers 1 16 refer to the monitor line of the corresponding current module i e number 1 corresponds to module 1 WARNING Devices connected to this port must be isolated from earth ground in compliance with IEC 60601 1 Equipment that does not meet these criteria could potentially transmit large voltage transients directly to the patient electrodes Patient Ground 11 The patient ground should be connected to the Patient Ground connector The CereStim M96 System provides a minimum isolation of 2 5 kV between the patient and the mains power supply Rev DRAFT 1 00 R LB 0495 BLAGI Page 3 Blackrock Microsystems CereStim M96 User Manual 9 92 93 94 9596 97 98 99 100 1 82 BJ 84 85 86 87 88 89 90 2 3 Computer Setup HZ FSA Fo fo FT TB 9 BO i 61 67 63 64 6566 67 68 69 70 The CereStim M96 uses a USB connection to 5152 53 54 55 56 57 58 59 60 CereStim C96 4147 43 44 45 46 47 48 49 50 31 32 33 34 35 36 37 38 39 40 2122 23 24 25 26 27 28 29 30 1112 13141516 17 18 19 20 0102 03 04 05 06 07 08 09 10 communicate with the PC No specific drivers are required for installation Installation occurs automatically upon connecting the device to the PC The Stim Manager Software runs on Windows 7 USB A B Cable 2 3 1 System Configuration Disclaimers Figure 2 4 Computer Setup
20. es including flammable anesthetic agents Only connect CereStim M96 components to properly tested grounded and dedicated AC outlets to reduce the risk of electrical shock Do not use an adapter for ungrounded wall outlets Do not use damaged components i e cables external power supply Damaged components may compromise patient and or operator safety Do not connect the CereStim M96 to an outlet controlled by a wall switch Avoid strong static discharges from sources like televisions or computer monitors as they can damage the electrical parts of the system Keep the CereStim M96 away from liquids Contact with water shower spray or wet surfaces can lead to the patient receiving an electrical shock and compromise patient safety Do not unplug the power supply to the CereStim M96 while the system is in use Do not connect disconnect any cables to from the CereStim M96 while the system is in use Do not leave the CereStim M96 connected to the patient electrodes or Stim Switch when the system is not in use Do not change CereStim M96 Output Voltage values while connected to the patient Doing so may result in an electric shock to the patient and compromise patient safety When connecting the CereStim M96 to the Stim Switch or patient electrodes use caution to minimize the likelihood of Electrostatic Discharge ESD Ensure that the CereStim M96 is securely positioned on a flat surface during use Use caution when placing power cords cables
21. ff before connecting disconnecting any cables 2 4 1 4 Connect the external power supply to the CereStim M96 and plug it into a wall outlet 2 4 1 5 Connect the USB port on the Front Panel of the CereStim M96 to a USB port on the computer with the USB A B cable included in packaging 2 4 1 6 Connect one end of the electrode cables to the CereStim M96 cable connectors on the Back Panel of the CereStim M96 Connect the other end of the cables directly Rev DRAFT 1 00 R LB 0495 pl Page 4 Blackrock Microsystems 2 4 1 7 Rev DRAFT 1 00 LB 0495 CereStim M96 User Manual to the connectors on the patient electrodes Refer to Figure 2 4 for a pinout of the locking connector on the CereStim M96 Open the Stim Manager Software on your PC and turn on the CereStim M96 The Status bar in the lower right hand corner of the Stim Manager window should indicate that the CereStim M96 is connected Refer to Section 3 below for further instructions regarding the use of the Stim Manager Software Page 5 B BI c AGKRO 3 Blackrock Microsystems CereStim M96 User Manual 3 Stim Manager Software The parameters of the biphasic current pulses output by the stimulator can be altered in the Stim Manager Software and updated to the CereStim M96 via a USB A B cable The Stim Manager main window is shown in Figure 3 5 below 3 1 Stim Manager Manual Mode Stim Manager has two working modes Manual Mode and Program Mode Manual mode is the defau
22. from the CereStim M96 The TTL Trigger port is rated for inputs between 3V and 5V Emergency Off 8 The emergency stop jack is used to attach an emergency stop switch not included if emergency stop capabilities are required for your application When activated the emergency stop controller will shut off all power to the CereStim M96 unit The CereStim M96 is designed for use with Normally Closed NC Emergency Stop Switches 2 2 CereStim M96 Back Panel The CereStim M96 Back Panel interfaces the CereStim M96 either directly to electrodes or to a Blackrock Stim Switch system g 32 30 28 26 24 22 2018 g 1513119 75 3 1 9 2 4 3 g 3129 27 25 23 2119 17 16 141210 8 6 4 2 g 6 5 8 7 g 64 62 60 58 56 54 52 50 g 47 45 43 41 39 37 35 33 9 10 9 12 11 14 13 16 15 g 6361 59 57 55 5351 49 48 46 44 42 40 38 36 34 g G G G Ge g 96 94 92 90 88 86 84 82 g 79 77 75 73 71 69 67 65 9 g 9593 91 89 87 85 83 81 80 78 76 74 72 70 68 66 g Figure 2 3 CereStim M96 Back Panel CereStim M96 Cable Connectors 9 Connectors A C provide a connection between the CereStim M96 and the Electrodes Connector A corresponds with output channels 1 32 connector B with channels 33 64 and connector C with channels 65 96 The layout of the CereStim M96 Cable Connector is shown in Figure 2 3 above Electrode connection cables are supplied for standard ECOG electrode types Monitor 10 Connection to the monitor allows users to observe the op
23. gures Figure 1 1 Application OVerview cccccccsssccccsseccccsecccascecsenscecsaseeeseuseccsaueeecsuseceseuseeesaaececsuseceseueeecsaaeeessuseeeseeeeesaueeeseas 1 FeUe 2 2 Coresi MIE Front Panel Luvvasasrk okse Ganddal r EE und 2 Figure 2 3 CereStim M96 Back Panel ccccccssssccccssccccesecccsenecesaaeeecsseceeseneeesseeeeessueeesseueeessueeeseuscessasesseaesesseseessaasessees 3 PIG UE 2 4 COMMU Gl SCTU EEE ES SSE EE A 4 Figure 3 5 Stim Manager Main Window cccccccsssccccsssecccensccsauscccssuscccsensecesaueeeeseueeeeseuseessaeeeseaeessaseesaaesessauseessausessags 7 Figure 3 6 Cathodic and Anodic Pulse FIQures csssscccccsssseccccesecceesueneeeceseaaeeeccesseseecessaeuecesseeaeeeesseeuseeesssuaseeessuaeeeeeeas 8 Figure 3 7 Status of Manual Mode Electrode Channels cccccssssecccccessecceceeseccceseesecceseeeeccesseeseceesseeueeeesseaeeeeesaaeeeeeees 9 Figure 3 8 Stim Manager Program Mode Wind OW ccccsssccccssseccsenecccsecccseuecceseueeesaueecessuecesseuecessausesseaeeessauseessansessaes 9 PICU oae POP Ni COON EE TN ER ER 10 Figure 3 10 Stim Manager Settings Window scccccssseccceseccccenscccsenecesseuecessueceeseuseceseecessaeseessascessauseessaesesseesessaeeess 12 Figure 3 11 Administrator Settings Window cccccccssecccsssccccenscccssnscccseuseeseuseesseusecssaecesaaueessauscesseuseessaesesseeeessanseess 13 Figure 3 12 Stim Manager Report WiInNdOW
24. ition Panel D Groups allow the user to generate stimuli from different current modules at the same time There are four basic rules for groups e Agroup must have both begin and end instructions e Agroup can t have more stimuli than enabled current modules e An electrode can t be used more than once in the same group e Wait instructions cannot be used within a group Program Sequence Panel E This panel stores the stimulation sequence created by the addition of single stimulation configurations groups and wait instructions The order within the sequence can be modified by clicking and dragging commands up or down within the sequence Single items in the program sequence can be deleted by selecting the item then clicking amp All items within a program sequence can by deleted by clicking the amp button Program Sequence Options F These options allow the user to open modify and save Program Sequences Open Pre existing program sequences and stimulation configurations can be opened from the Program Files directory as defined in the Settings option of the Tools Menu Save As This allows users to save newly created Program Sequences and Stimulation Waveforms to the Program Files Directory Save Allows users to save modifications to a program sequence Delete Program amp Individual programs are deleted from the Program List Panel by clicking the Delete Program button Stimulation Waveforms Panel 2 This panel displays all s
25. lt for Stim Manage and is intended for single stimulation applications In this mode the user selects an electrode channel from the Electrode Array Panel 3 and creates a Pulse Configuration in the Waveform Panel 2 Stimulation scripts are not available in this mode R Stim Manager File Mode Tools Help Waveform List Waveform Electrode Array Polarity Cathodic First Number of Pulses Phase 1 Amplitude ua Phase 1 Width uSec Interphase Delay fp uSec Phase 2 Amplitude ua Phase 2 Width uSec Pulse Frequency pO Hz afl a m a gt ofa 9 of 0 xf fof 9 mf Stimulate Cerestim 96 Disconnected Figure 3 5 Stim Manager Main Window Status Bar 1 The status bar can be in one of two following states CereStim 96 Disconnected and CereStim 96 Connected The CereStim M96 must be powered on in order for the software to recognize the connection Once connected the CereStim M96 can be disconnected in one of two ways 1 powering off the stimulator and 2 selecting Disconnect Alt D from the Mode Menu The stimulator can be reconnected by selecting Connect Alt C from the Mode Menu Rev DRAFT 1 00 R LB 0495 BLAS P 6 crock Blackrock Microsystems CereStim M96 User Manual Waveform Panel 2 This panel allows the user to define single stimulation parameters The available features are as follows Polarity The user can set the stimulator to generate
26. m M96 User Manual Guidance and Manufacturer s Declaration Electromagnetic Immunity The CereStim M96 is intended for use in the electromagnetic environment specified below The customer or the user of the CereStim M96 should assure that it is used in such an environment Electromagnetic Environment Immunity Test IEC 60601 Test Level Compliance Level Electrostatic Discharge ESD IEC 61000 4 2 Electrical Fast Transient Burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power Frequency 50 60 Hz magnetic field IEC 61000 4 8 6kV Contact 8kV Air 2kV for power supply lines 2 kV for input output Lines 1kV line s to line s 2kV line s to earth lt 5 UT gt 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles lt 5 UT gt 95 dip in UT for 5 sec Not Applicable 2kV for power supply lines 2 kV for input output Lines Not Applicable Not Applicable Not Applicable Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Mains power quality should
27. nd Stimulation Waveforms are saved on the PC Locations are modified by clicking a and navigating to the desired directory Update Options 4 or Settings x Unlock Administrator Rights Apply This option saves any modifications made in the Directories panel Cancel This option closes Max Output Voltage the Stim Manager Settings Max Amplitude Window without saving any changes OK This option saves all Max Width Max Charge Per Phase changes before closing the Max Frequency sd Stim Manager Settings ee Window Change Password 3 4 Administrator Settings on The options in the Administrator Settings i Enter New Password allow the user to put limits on the maximum available values for the Confirm New Password stimulation configuration parameters All changes are password protected in order to prevent unauthorized users from modifying the maximum parameter values The Administrator Settings Window is shown in Figure 3 11 to the right Change Password Figure 3 11 Administrator Settings Window Unlock Administrator Rights Panel 1 Unlocking the Administrator Rights allows users to restrict the Output Vmax Amplitude Phase Width Charge per Phase and Frequency parameter values to a set of maximum values Upon initial start up the administrator password is set to cerestim96 After unlocking the administrator rights the user can change this password in the Change Password panel
28. parameter set by the user The interpulse delay requires a minimum of 43 us NOTE The interpulse delay is not a parameter made available to the user Values for the interpulse delay are calculated based on the pulse widths interphase delay and frequency of a stimulation pulse 6 Warranty Blackrock Microsystems LLC warrants that its products are free from defects in materials and manufacturing for a period of one year from the date of shipment Blackrock will at its option repair or replace any product that does not comply with this warranty This warranty is voided by 1 Any modification or attempted modification to the product done by anyone other than an authorized Blackrock employee 2 Any abuse negligent handling or misapplication of the product Rev DRAFT 1 00 Page 15 re Barackrosx Blackrock Microsystems CereStim M96 User Manual This constitutes the sole warranty made by Blackrock There are no other warranties expressed or implied which extend beyond those described herein or to anyone other than the original purchaser including the implied warranties of merchantability and fitness for a particular purpose In no event shall Blackrock Microsystems LLC be liable for any incidental or consequential damages or for the infringement of any patent rights or third party rights due to the use of its products 7 Return Merchandise Authorization In the unlikely event that your system needs to be returned to Blackrock for rep
29. power prior to cleaning the instrument Clean the outside of the CereStim M96 using a cloth dampened with water or alcohol when necessary Do not submerge the device in water or cleaning solutions Use a brush to dislodge any dirt on or around the connectors WARNING The CereStim M96 should be cleaned by highly qualified personnel who are trained in techniques to prevent cross contamination and infection e Keep the device away from liquids The CereStim M96 is not fluid resistant and can become damaged by fluid ingress e Store the CereStim M96 at 20 C to 50 C 10 to 100 relative humidity non condensing 5 Troubleshooting Stim Manager does not recognize the CereStim M96 am unable to send commands from Stim Manager to the CereStim M96 1 Make sure that your PC recognizes the CereStim M96 as an HID interface Right Click on My Computer in the Start up Menu and select Manage Select Device Manager expand the Human Interface Devices List and confirm that your USB device is recognized If the USB is not recognized the CereStim M96 may require a shorter USB cable 2 Check to make sure that all connections are secure 3 Ifthe problem persists contact Blackrock Microsystems support at support blackrockmicro com for additional troubleshooting or to initiate an RMA Stim Manager returns a frequency error when try to stimulate 1 Verify that the combination of the pulse widths and interphase delay do not exceed the frequency
30. rder to e Send the pulse configurations to the available current modules within the CereStim M96 unit e Check for correct syntax of the groups in the Stimulation Script e Assign a current module to each stimulus e Send the Stimulation Script to the CereStim M96 motherboard e Calculate the total elapsed time for the Stimulation Script recorded in the Log Window Timing measurements depend on the pulse configurations and internal hardware delays The internal hardware delays are as follows O O O 68 us delay between single stimulations 76 us delay between the end of a stimulus and the beginning of a group 68 us delay between the end of a group and the beginning of another stimulus 116 us delay between the end of a group and the beginning of another group Pause Clicking this button pauses the stimulation following completion of the current command in the program sequence This prevents the system from sending an unbalanced charge To resume stimulation from the same point in the program click the Play button Stop Clicking this button manually stops the stimulation Log Panel 7 The Log Panel echoes commands sent from the Stim Manager Software to the CereStim M96 and provides the user with results from the Test Modules and Test Electrodes functions see sections 3 6 and 3 7 below Information stored in the Log Panel is written to the Report Window and can be saved in a TXT file format The Report Window is access
31. rmal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the CereStim M96 P Over the frequency range 150 kHz to 80 MHz field strength should be less than 3 V m System Specifications Rev 1 00 Page vi LB 0495 Be ASKRO Blackrock Microsystems CereStim M96 User Manual Number of Output Channels a Train Duration 5 000us 34 442 850us 0 005 34 4 seconds 1 255 pulses train Pulse Duration 2 544us 69 535us 0 002544 0 069535 seconds Anodic Pulse Duration 44 2 000us phase Cathodic Pulse Duration 44 2 000us phase Adjustable in 1us increments Recommended Electrode lt 100 kQ Impedance PC Hardware Interface USB A B cable Compatibility PMP15M 13 Protek Power Supply AC Input 100 240Vac 0 5 0 3A 50 60Hz The system was only evaluated to 120V 60Hz DC Output 15V 1A MAX Normally Closed Switch with lt 100 on resistance recommended Manufacturer Assman Electronics AWH40G 0222 T R 10 pin dual row header 2 56mm pitch Manufacturer Samtec SSQ 110 01 G D 15 C to 60 C 10 to 85 R H non condensing 500 to 1060 hPA Environment External Power Supply Rev 1 00 Page vii LB 0495 Barackrock Blackrock Microsystems CereStim M96 User Manual 1 System Overview The CereStim M96 is a fully programmable neurostimulator with 96 output channels and the capability of producing up to 16 simultaneous stimuli The biphasic cu
32. rrent pulses generated by the CereStim M96 are intended to stimulate neurons in proximity to a set of implanted electrodes By interfacing the CereStim M96 with a switching system for stimulation and recording the CereStim M96 becomes a very flexible and powerful tool for analyzing neural signals The figure below shows an application overview of how the CereStim M96 fits into a switching system for stimulation and data acquisition applications CereStim M96 Neural Stimulation Electrodes USB A B Cable Figure 1 1 Application Overview 1 1 Packing List 1 CereStim M96 1 External Power Supply 1 USB A B Cable 1 Stim Manager Software CD ROM 1 CereStim M96 User Manual Rev DRAFT 1 00 R LB 0495 BLACKROCK Page I Blackrock Microsystems CereStim M96 User Manual 2 Hardware The CereStim M96 is a constant current neurostimulator that is capable of delivering up to 3 simultaneous current waveforms to 96 electrodes The number of simultaneous current waveforms can be upgraded to 16 2 1 CereStim M96 Front Panel The CereStim M96 Front Panel interfaces the PC with the CereStim M96 hardware CereStim M96 configuration is accomplished using the Stim Manager program described in Section 3 Figure 2 2 CereStim M96 Front Panel Power Supply Connector 1 The CereStim M96 is powered by a medical grade power supply that is included as part of the CereStim M96 packaging The green LED labelled Power will light
33. sic pulses are available for each Configuration Range of Interphase Delay 53 65 535 us Range of Amplitudes Phase I amp Phase Il 1 215 uA Phase Width Phase I amp Phase II 44 2 000 us Hz 8 200 Hz NOTE Stim Manager will only accept whole number values Add Waveform Pre existing stimulation waveforms can be added by selecting the amp button Remove Waveform Individual waveforms can be removed from the panel by selecting the amp button Rev DRAFT 1 00 Page 9 LB 0495 Barackrosk Blackrock Microsystems CereStim M96 User Manual Remove All All waveforms are removed by selecting the amp button Stimulus Panel B This panel allows the user to select an electrode channel 1 96 and assign it to an electrode configuration from the Stimulation Waveforms Panel By clicking Add the electrode channel and electrode configuration pairs are added to the Program Sequence Wait Instruction Panel C Wait instructions allow the user to introduce delays in milliseconds to the program sequence Delays can be added before or after any single stimulus or group By clicking Add the wait instruction is added to the Program Sequence NOTE An interpulse delay is executed at the end of each biphasic pulse depending on the frequency parameter set by the user This delay is not included in the wait instruction and should be added to the delay between pulses as a separate parameter from the wait instruction Group Defin
34. timulation pulses and sequences sent from the CereStim M96 during each session of Stim Manager This window also provides the user with results from the Test Modules and Test Electrodes functions 3 6 Test Modules The CereStim M96 has an auto check function called Test Modules 3 5 located in the Tools Menu of Stim Manager When the Test Modules button is selected the system sends a pulse to an internal 100 KQ resistor and measures the output voltage at five different points of the test pulse Figure 3 14 Figure 3 13 Test Pulse If the output voltages are in line with the parameters of the current pulse then the module is OK If not Stim manager provides the following message ERROR Possible voltage limitation Please check it This error indicates that Vmax may need to be adjusted The Test Modules function can be activated either from the Tools Menu of Stim Manager or by CTRL SHIFT M 3 7 Test Electrodes Test Electrodes Tools Menu of Stim Manager sends a stimulus to each of the enabled electrodes and measures the output voltages at five different points of the pulse same as Test Modules These values are provided in the Log Window of the Report Tab During this test the system also checks the second voltage point of the pulse to determine if it s close to the Output Vmax If it is then the message HIGH IMPEDANCE Possible voltage limitation appears and the user should adjust the Output Vmax value or re
35. timulation waveforms created in the Program Creator for the selected program Program Sequence Panel 3 This panel displays the sequence of single stimulations groups and wait instructions for the selected program Trigger Panel 4 This panel provides options for use of the CereStim M96 trigger feature When enabled this feature requires an input signal of 3 3V to 5V Disabled Trigger is non functional Rising Edge Stimulation is triggered to begin at the rising edge of the input signal Falling Edge Stimulation is triggered to begin at the falling edge of the input signal Rev DRAFT 1 00 R LB 0495 BLAGK Page 10 Blackrock Microsystems CereStim M96 User Manual Either Edge Stimulation is triggered to begin at both the rising and falling edges of the input signal Repetition Panel 5 This feature allows the user to repeat the Program Sequence a specified number of times or to run it as a continuous loop Without a defined number of repetitions the CereStim M96 defaults to a single pass of the Program Sequence In a continuous loop the CereStim M96 requires a manual stop in order to end stimulation Stimulate Panel 6 Provides options for starting pausing and stopping a stimulation sequence Play Stimulation is initiated by clicking the Play button A program must be selected and verified from the Program List Panel prior to the start of stimulation Verification of the stimulation sequence must be done in o
36. up when the external power supply is connected to the unit WARNING Do not use a third party power supply with CereStim M96 On Off Switch 2 Use the on off switch to turn on the CereStim M96 The green LED labelled On will illuminate when the unit is turned on LED Indicators 3 The green LEDs labelled On and Power illuminate when the CereStim M96 unit is turned on and powered through the external power supply The Status LED illuminates during activity on the USB port to indicate communication between the CereStim M96 and PC USB Port 4 The CereStim M96 is programmed through commands sent via a USB A B cable connected between the USB port on the CereStim M96 and a USB port on the PC The Status LED illuminates during activity on the USB port RS 232 Port 5 This feature has not been implemented in the current version of the CereStim M96 The RS 232 port is intended to provide hardware hardware communication in future firmware updates of the device Rev DRAFT 1 00 Re Page 2 LB 0495 Blackrock Microsystems CereStim M96 User Manual TTL Sync 6 The TTL Sync output signal is intended to be used as a method for synchronizing external data acquisition systems The TTL goes high 60 us before stimulating and goes low once the stimulation sequence is complete TTL Trigger 7 The TTL Trigger is intended to provide the user with a method for using external devices to trigger a stimulation pulse
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