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Summary of Contents for Stereotaxis Niobe PM3.1
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EXHIBIT G Stereotaxis Installation Checklists...
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PM3.2 Conversion to PM3.1 4320 Forest Park Avenue, Suite 100 St. Louis, MO 63108 1-866-646-2346 1-314-678-6100 Manual P.N.: 985-006001 www.stereotaxis.com Revision: Effective Date: 03 June 2008 WARNING: This is a revision controlled document. Verify revision is correct prior to use.
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03/14/06 05-970 Update for -22 Niobe software release; C. Hayen 07/24/06 06-379 Update per Field Service markups; J. Thebeau Add PM3.2 to PM3.1 conversion steps Update X-ray Simulator compatibility table C. Hayen 03 June 2008 08-193 Stereotaxis, Inc. Page ii...
860-003000-15 → -17 V 2.5 Build 0 860-004466-5 Up to V 3.16 * It is required that all versions of X-ray Simulator older than the ones stated above be updated to the latest released version. Stereotaxis, Inc. Page 4 of 43...
Sign, date, and print your name in the appropriate spaces on signoff forms. • Check the appropriate boxes for this site in the table below. System Configuration ® NIOBE (If NO skip section 5) ® CARDIODRIVE (If NO skip section 6) Stereotaxis, Inc. Page 5 of 43...
4. Replace/upgrade all existing system documents with the system documents included in the system conversion kit. 5. Replace existing system nameplate labeling on cabinet and pods with nameplates included in system conversion kit. 6. Perform verification tests in section 4, 5, and 6. Stereotaxis, Inc. Page 6 of 43...
(Green) illuminated (Red) Emergency Stop System/Positioner (E-Stop). Press to power on/off halt all mechanical motion. Figure 1 – System Control / Remote Stop** (001-005000-1 and 001-006000-1 configuration shown) Stereotaxis, Inc. Page 9 of 43...
Effective Date: 03 June 2008 Figure 2 – Table Side Controller with Graphics (PM3.2 Version: 001-006000-1)** ** NOTE: E-Stop Button and/or E-Stop Light are not present on 001-005100-1 and 001-006100-1 configurations of Power Box or Table Side Controller. Stereotaxis, Inc. Page 10 of 43...
Verify that while the Positioner is moving the green indicator for the location the Positioner has been requested to move to blinks during the move. • Verify that the total time to move to Navigate position does not exceed 60 seconds. Stereotaxis, Inc. Page 11 of 43...
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Verify that the total time to move from Navigate to Stowed does not exceed 30 seconds. • Verify that the first 20 of movement, on Pivot axis, towards stowed does not exceed 15 seconds. Stereotaxis, Inc. Page 12 of 43...
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Navigate LAO is displayed on the control room and procedure room monitors. • Verify that while the Positioner is moving the green indicator for the location the Positioner has been requested to move to blinks during the move. Stereotaxis, Inc. Page 13 of 43...
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• Now simultaneously hold the Image Transfer and the appropriate Movement button to initiate the interlock override condition and verify that the system will begin to move with the Stow position button pressed. Stereotaxis, Inc. Page 14 of 43...
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Pivoting. • Verify that you observed the following icon when you release the motion button prior to the requested position being achieved. Stereotaxis, Inc. Page 15 of 43...
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Verify that the Retracted Icon is displayed if the tableside controller motion button is released prior to the movement being completed when Tilting. • Verify that you observed the following icon when you release the motion button prior to the requested position being achieved. Stereotaxis, Inc. Page 16 of 43...
With the system operational remove the Category 5 cable from connector J2 on the Control cabinet. Verify that the system reports a Missing Information icon. ® Verify that the Niobe System reports a loss of communication with the Stereotaxis, Inc. Page 17 of 43...
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Control cabinet. Remove the connectors one at a time to verify that either connector will result in lost connectivity. Verify that the system displays the red “Cannot Communicate with the Magnet Positioners” message. Stereotaxis, Inc. Page 18 of 43...
• Repeat for the following tip orientations: Anterior Tip Orientation Posterior Tip Orientation Left Lateral Tip Orientation Right Lateral Tip Orientation • Verify that the catheter tip orients in the expected direction. Stereotaxis, Inc. Page 19 of 43...
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Verify that the Preset list of Cardinal Vectors can be accessed and applied. • Verify that the preset list dialog box appears on the Navigant monitor. • Select each preset vector and apply the field • Verify that the vector is applied. Stereotaxis, Inc. Page 20 of 43...
Move magnets to the stowed position ® Turn Niobe Verify X-ray C-arm now moves at normal/full speed. Verify an X-ray fluoro image can be obtained. Hardware E-stop Interconnectivity. ® Turn Niobe back on Stereotaxis, Inc. Page 21 of 43...
Attempt Niobe motorized movement and verify that this is not possible • Move the Allura L-arm to the head-end locked position in working position 2 • Attempt Niobe motorized movement and verify that this is possible Stereotaxis, Inc. Page 22 of 43...
• Repeat at Navigate RAO and LAO positions. • Repeat for the other Positioner. • Verify that the no interference was detected on MP1. • Verify that the no interference was detected on MP2. Stereotaxis, Inc. Page 23 of 43...
Verify that none of the measured magnetic field strengths exceeded 0.5 milliTesla* (5.0 Gauss). Record the final result below: PASS _____ FAIL _____ Test Performed by: Signature: __________________________________Date: ___________ Print Name: ______________________________________ The units displayed on a THM-7025 are milliTesla Stereotaxis, Inc. Page 24 of 43...
E-stop button on the Allura TSO in the Control room. • Verify that the red light labeled “E Stop Active” behind the left hand front door of the Control cabinet illuminates and all motion of the MPs is inhibited. Stereotaxis, Inc. Page 25 of 43...
Emergency Stop power on when is activated when illuminated (Green) illuminated (Red) Emergency Stop System/Positioner (E-Stop). Press to power on/off halt all mechanical motion. Figure 3 System Control / Remote Stop (Siemens PM3.1 Version) Stereotaxis, Inc. Page 26 of 43...
While the Positioner is in the Stowed position press and hold Navigate position button: on the tableside controller until the Positioner reaches the Navigate position. • Verify that the Navigate Position indicator: is displayed on the control room and Stereotaxis, Inc. Page 27 of 43...
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• Verify that the total time to move from Navigate to Stowed does not exceed 30 seconds. • Verify that the first 20 of movement towards stowed does not exceed 15 seconds. Stereotaxis, Inc. Page 28 of 43...
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• Verify that while the Positioner is moving the green indicator for the location the Positioner has been requested to move to blinks during the move. Stereotaxis, Inc. Page 29 of 43...
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• Verify that the total time to move from Retracted to Stowed does not exceed 30 seconds. • Verify that the first 20 of movement towards Stowed does not exceed 15 seconds. Stereotaxis, Inc. Page 30 of 43...
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Verify that the system between locations Icon is displayed if the tableside controller motion button is released prior to the movement being completed. • Verify that you observed the following icon when you release the motion button prior to the requested position being achieved. Stereotaxis, Inc. Page 31 of 43...
39 , or use the X-ray simulator to send a files, between transferring the first image and the second image. Verify that the Images Invalid Icon is displayed, which is a large yellow “X”. Stereotaxis, Inc. Page 32 of 43...
Click the apply field button on the display and observe the catheter tip. Verify that the catheter tip is now in Cranial tip orientation and the Applied Field icon is displayed. • Verify that you observed the appropriate overlay information of Stereotaxis, Inc. Page 33 of 43...
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Verify that the Preset list of Cardinal Vectors can be accessed and applied. • Verify that the preset list dialog box appears on the Navigant monitor. • Select each preset vector and apply the field • Verify that the vector is applied. Stereotaxis, Inc. Page 34 of 43...
® Turn Niobe back on Press the Niobe® procedure room E-stop (on the tableside ® controller) IN. Verify both Niobe and X-ray recognize the E-stop condition. Pull the E-stop back out. Stereotaxis, Inc. Page 35 of 43...
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Using the hand crank, move Niobe MP1 out of stowed and verify that Allura UI displays “To continue please stow Niobe”. Move MP1 back to stowed. Repeat procedure for MP2 Stereotaxis, Inc. Page 36 of 43...
“ping 192.168.168.2”, followed by a carriage return. • Verify that the ping command completes successfully by noting that the number of packets sent is equal to the number of packets received, and that no packets were lost. Stereotaxis, Inc. Page 37 of 43...
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Verify free overrides, (Manufacturing to verify overrides only if NWS version is 2.0.7 or less.) Verify Navigant system is set up with a significant number of overrides. (Field Service to verify all NWS versions) Stereotaxis, Inc. Page 38 of 43...
Verify the joystick and the +/- controls do not function on ® both the tableside and control room Cardiodrive User Interface. • ® Raise the tableside Cardiodrive User Interface E-stop and verify that both power on and E-stop indicator lights for the Stereotaxis, Inc. Page 40 of 43...
Installation Completed in Accordance with HDW-037 Cardiodrive Installation, Operation and Service Manual ® I hereby certify that the Cardiodrive System is installed and functioning within published specifications: Sign Name: ___________________________ Date: ________________ Print Name: ___________________________ Company : ___________________________ Stereotaxis, Inc. Page 41 of 43...
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Niobe Installation Manual ® Calibrations Completed in Accordance with HDW-0114 or -0138 Niobe Magnet Positioners Alignment and Calibration. ® The Calibration Results/Checklist per HDW-0114 or -0138 Niobe Magnet Positioners Alignment and Calibration is included? Stereotaxis, Inc. Page 42 of 43...
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This section to be completed when the Artis or Allura has been installed and we can verify joint functionality ® I hereby certify that the Niobe Magnetic Navigation System is installed and functioning within published specifications: Stereotaxis Sign-off Sign Name: ______________________ Date: _______________ Print Name:...
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EffectiveDate:07/24/2012 Vdrive & Vdrive Duo Installation Test and Verification Procedure 4320 Forest Park Avenue Suite 100 St. Louis, MO 63108 1-866-646-2346 1-314-678-6100 WWW.Stereotaxis.com WARNING: This is a revision controlled document. Verify revision is correct prior to use Stereotaxis, Inc. Confidential...
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2. SCOPE: • This procedure applies to verifying the proper installation of the Vdrive and Vdrive Duo for Stereotaxis Inc service personnel. 3. APPLICABLE DOCUMENTS: • 001-002307-1 BOM, Vdrive System •...
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NWS S/W Version:_________________ Niobe S/W Version:_________________ Vdrive or System Serial Number:_________________ Vdrive Duo RMS Control Box Serial #______________ (Select One) Serial Number:_______________________ OBUI Software Part#:___________________ WARNING: This is a revision controlled document. Verify revision is correct prior to use Stereotaxis, Inc. Confidential...
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Manual document number HDW-0210 sections 7, 7.1 and 7.2 • Complete installation of the Vdrive Controller as detailed in the Installation Manual document HDW0210 ____ section 8. WARNING: This is a revision controlled document. Verify revision is correct prior to use Stereotaxis, Inc. Confidential...
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• Power indicator lights on Vdrive control box are on (Illuminated): • AC Power (This is not as bright as the DC ____ insdicator light) ____ DC Power ____ Niobe Status WARNING: This is a revision controlled document. Verify revision is correct prior to use Stereotaxis, Inc. Confidential...
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• For a Vdrive Duo system, attach the Handle Clamp assy ____ to Drive Unit “B.” Please Wait-Checking Disposable Validity appears on screen. WARNING: This is a revision controlled document. Verify revision is correct prior to use Stereotaxis, Inc. Confidential...
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____ • Navigate Control. Allows function of the mouse controller in Control Room. ____ • The following screen should now be displayed. ____ WARNING: This is a revision controlled document. Verify revision is correct prior to use Stereotaxis, Inc. Confidential...
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• Navigate Control. Allows function of the mouse controller in Control Room. ____ • The following screen should now be displayed. ____ 11. Vdrive Movement from Control Room Contoller WARNING: This is a revision controlled document. Verify revision is correct prior to use Stereotaxis, Inc. Confidential...
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• Tilt or Push Knob Right, Drive Moves Forward ____ (Deflects Catheter). • Tilt or Push Knob Left, Drive Moves Back (Un-Deflect ____ Catheter). Test Description Pass/Fail Initials WARNING: This is a revision controlled document. Verify revision is correct prior to use Stereotaxis, Inc. Confidential...
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• Push the “+” Button, Moves the Blue Drive Counter Clockwise (Lasso Loop Larger). ____ • Push the “–“button, Moves Blue Drive Counter ____ Clockwise (Lasso Loop Smaller). WARNING: This is a revision controlled document. Verify revision is correct prior to use Stereotaxis, Inc. Confidential...
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• Push or Tilt Knob Back. Indicator on Display moves. ____ • Push or Tilt Knob Left. Indicator on Display Moves. ____ • Push or Tilt Knob right. Indicator on Display Moves. WARNING: This is a revision controlled document. Verify revision is correct prior to use Stereotaxis, Inc. Confidential...
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• Activate (Push down) the E-Stop Switch on the Vdrive Control Box. The Red E-Stop indicator Light should be Illuminated. ____ • The E-Stop is Active is displayed on the OBUI. ____ WARNING: This is a revision controlled document. Verify revision is correct prior to use Stereotaxis, Inc. Confidential...
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• The Red E-Stop Light on the Niobe On/off box is ____ illuminated. • The V-Drive E-Stop Icon on Navigant is displayed. ____ Test Description Pass/Fail Initials WARNING: This is a revision controlled document. Verify revision is correct prior to use Stereotaxis, Inc. Confidential...
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• Pull out (De-Activate) the E-Stop on the Niobe On/off box. The Red E-Stop Light is Not Illuminated. ____ Test Description Pass/Fail Initials WARNING: This is a revision controlled document. Verify revision is correct prior to use Stereotaxis, Inc. Confidential...
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The E-Stop Active is Not Displayed on the OBUI. • The Red E-Stop Light on the Vdrive Control Box is Not ____ Illuminated. WARNING: This is a revision controlled document. Verify revision is correct prior to use Stereotaxis, Inc. Confidential...
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Control Box. The Red E-Stop indicator Light is Illuminated. ____ • The E-Stop is Active is displayed on the OBUI Tableside Controller. ____ WARNING: This is a revision controlled document. Verify revision is correct prior to use Stereotaxis, Inc. Confidential...
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The E-Stop Active is No Longer Displayed on the ____ OBUI Tableside Controller. • The following screen is displayed on the OBUI Tableside Controller: ____ WARNING: This is a revision controlled document. Verify revision is correct prior to use Stereotaxis, Inc. Confidential...
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Print Name: _________________________ Return a copy of the completed sections of this document along with all attachments to Manager of Field/Tech Support. Stereotaxis Management Sign off: Sign Name:_____________________________ Date: __________________ Print Name:_____________________________ WARNING: This is a revision controlled document. Verify revision is correct prior to use Stereotaxis, Inc.
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Updates A. Miller 11-585 10-Nov-2011 Update to include Vdrive Duo B. Kidd Add additional site information. 12-073 07/24/2012 Edit for Clarity A. Miller WARNING: This is a revision controlled document. Verify revision is correct prior to use Stereotaxis, Inc. Confidential...
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Verification and Testing 4320 Forest Park Avenue, Suite 100 St. Louis, MO 63108 1-866-646-2346 1-314-678-6100 Manual P.N.: 985-007011 www.stereotaxis.com Revision: Revision Date: 08/07/2012 “WARNING: This is a revision controlled document. Verify revision is correct prior to use.” Stereotaxis, Inc Confidential...
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Revision: Verification and Testing Page 2 of 19 Effective Date: 08/07/2012 REVISION HISTORY Description Author Date ECO# Initial release K. Eversman 08/07/2012 12-286 “WARNING: This is a revision controlled document. Verify revision is correct prior to use.” Stereotaxis, Inc Confidential...
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TABLE 1 - ELECTRICAL POWER WITH A NEUTRAL WIRE PRESENT ............ 6 TABLE 2 - ELECTRICAL POWER WITHOUT A NEUTRAL WIRE PRESENT ..........6 TABLE 3 - CONNECTION CROSS REFERENCE ..................18 “WARNING: This is a revision controlled document. Verify revision is correct prior to use.” Stereotaxis, Inc Confidential...
• Record software version numbers in the boxes provided. • Sign, date, and print your name in the appropriate spaces on signoff forms. “WARNING: This is a revision controlled document. Verify revision is correct prior to use.” Stereotaxis, Inc Confidential...
(if present) before making a determination that system voltage is present or not (Corner grounded Delta will measure as zero volts from 1 phase to ground). “WARNING: This is a revision controlled document. Verify revision is correct prior to use.” Stereotaxis, Inc Confidential...
L1 – L2 = 230VAC Tolerances Met? Tolerances Met? Yes / No Yes / No Table 2 - ELECTRICAL POWER WITHOUT A NEUTRAL WIRE PRESENT “WARNING: This is a revision controlled document. Verify revision is correct prior to use.” Stereotaxis, Inc Confidential...
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Effective Date: 08/07/2012 Disconnect power from the panel Replace panel cover. Measurements Performed by: Signature:___________________________________ Date:____________ Print Name:__________________________________ Company Name: ______________________________ “WARNING: This is a revision controlled document. Verify revision is correct prior to use.” Stereotaxis, Inc Confidential...
W623 from Control Room (Ground Cable) Disconnect all external systems from the Odyssey Quad Procedure Room Hub. Disconnect associated TPI-J1 from all external systems. “WARNING: This is a revision controlled document. Verify revision is correct prior to use.” Stereotaxis, Inc Confidential...
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When finished measuring, reconnect the Protective Earth ground wire to the ground bus bar (E1) located inside the Odyssey Cabinet. Record the Insulation Resistance test results on the Electrical Safety Verification Summary. “WARNING: This is a revision controlled document. Verify revision is correct prior to use.” Stereotaxis, Inc Confidential...
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Verify any other Monitor that will be connected to the Odyssey Quad system has been disconnected at this time (Video, Ground and Power). “WARNING: This is a revision controlled document. Verify revision is correct prior to use.” Stereotaxis, Inc Confidential...
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Perform the following steps to make the measurement: Ensure the jumper plug is installed in the back of the HYAMP III model 3130. “WARNING: This is a revision controlled document. Verify revision is correct prior to use.” Stereotaxis, Inc Confidential...
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Connect the P/N 05002D-37 Cable Assembly High Current Return to one end of the external test wire to be used to connect the HYAMP III to the Stereotaxis equipment. Connect the P/N 05002D-24 Cable Assembly High Current to the other end of the external test wire to be used to connect the HYAMP III to the Stereotaxis equipment.
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Record the Ground Bond test results on the Electrical Safety Verification Summary. On the HYAMP III Model 3130 press the red pushbutton labeled “RESET”. “WARNING: This is a revision controlled document. Verify revision is correct prior to use.” Stereotaxis, Inc Confidential...
Earth Resistance Electrical Safety Testing Performed by: Signature: _________________________________ Date: ___________________________________ Print Name: ________________________________ Company Name: __________________________ Test Summary: Pass: _______________ Fail: _______________ “WARNING: This is a revision controlled document. Verify revision is correct prior to use.” Stereotaxis, Inc Confidential...
S/W and above and Std Labs). _______________________________________________ • Verify these software versions are the latest released versions. If not, provide explanation here: _____ _______________________________________________ “WARNING: This is a revision controlled document. Verify revision is correct prior to use.” Stereotaxis, Inc Confidential...
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Verify the Odyssey power light is illuminated and the main Odyssey screen is displayed on all applicable monitors after the Odyssey system boots up. “WARNING: This is a revision controlled document. Verify revision is correct prior to use.” Stereotaxis, Inc Confidential...
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Verify the Remote Service "Home" screen appears and the correct ______ hospital and lab name are shown at the top of the screen as shown in this example: “WARNING: This is a revision controlled document. Verify revision is correct prior to use.” Stereotaxis, Inc Confidential...
Workstation Installation Manual Signature: Date: Print Name: _________________________________ Company Name: _____________________________ Return a copy of the completed sections of this document along with all attachments to Manager of Field/Tech Support Stereotaxis Management Sign off Sign Name: ______________________________ Date: _____________________ Print Name: ______________________________ “WARNING: This is a revision controlled document.
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Verification and Testing 4320 Forest Park Avenue, Suite 100 St. Louis, MO 63108 1-866-646-2346 1-314-678-6100 Manual P.N.: 985-007842 www.stereotaxis.com Revision: Revision Date: 21 May 2012 “WARNING: This is a revision controlled document. Verify revision is correct prior to use.” Stereotaxis, Inc Confidential...
Odyssey Cinema Studio Telepresence Verification (If Available) ..........6 3.4. Odyssey Cinema Studio Broadcast Verification ................7 3.5. Odyssey Cinema Studio System Verification Checklist ..............8 Installation Complete Checklist ......................9 “WARNING: This is a revision controlled document. Verify revision is correct prior to use.” Stereotaxis, Inc Confidential...
Pass/Fail column. Record software version numbers in the boxes provided. Sign, date, and print your name in the appropriate spaces on signoff forms. “WARNING: This is a revision controlled document. Verify revision is correct prior to use.” Stereotaxis, Inc Confidential...
Verify Odyssey Studio hardware labeling. Verify the Odyssey Cinema Studio labels (197-006504-1 thru -5) are affixed to: • Front of the Studio Computer _____ • IPV XP-100 • Each Monitor “WARNING: This is a revision controlled document. Verify revision is correct prior to use.” Stereotaxis, Inc Confidential...
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_______________________________________________ Verify Odyssey Cinema Studio System labeling. Verify the Odyssey branding is displayed: • Desktop Background _____ • User Icon • Link Toolbar “WARNING: This is a revision controlled document. Verify revision is correct prior to use.” Stereotaxis, Inc Confidential...
Studio. • Confirm that the audio from the Telepresence system can be heard through the Studio headset and speakers. _____ “WARNING: This is a revision controlled document. Verify revision is correct prior to use.” Stereotaxis, Inc Confidential...
Pass/Fail Initials As a preliminary step, contact the manager of the Broadcast Calendar at Stereotaxis and ensure that no other broadcast is _____ in progress. (The equipment at the Colo can only be connected to one customer at a time.) Using Studio, play a sample video clip using Windows Media Player.
I hereby certify that the Odyssey Cinema Studio System is installed and functioning within published specifications: Signature: _______________________________ Date: ____________________ Print Name: _______________________________ Company Name: ______________________________ “WARNING: This is a revision controlled document. Verify revision is correct prior to use.” Stereotaxis, Inc Confidential...
Signature: Date: Print Name: Company Name: Return a copy of the completed sections of this document along with all attachments to Manager of Field/Tech Support Stereotaxis Management Sign off Sign Name: ____________________________ Date: _________________ Print Name: ____________________________ “WARNING: This is a revision controlled document. Verify revision is correct prior to use.”...
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