Medtronic 9733883 Instructions for Use

Leica Microsystems Microscope Interface for
StealthStation
S8 Systems with Cranial Quick Reference Guide
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Contents
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Intended use
The Medtronic Navigation microscope bracket is an accessory to the StealthStation™ system. The microscope bracket interfaces with the Leica microscope and StealthStation
Indications for use
The StealthStation™ System is intended as an aid for precisely locating anatomical structures in either open or percutaneous surgical procedures. The StealthStation™ System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long bone, or vertebra can be identified relative to a CT- or MR­based model, fluoroscopy images, or digitized landmarks of the anatomy.
Contraindications
None.
Material composition
Material contained in product that can cause an allergic reaction: nickel
Additional materials of concern information such as REACH, CA Prop 65 or other product stewardship programs, go to www.medtronic.com/productstewardship.
to enable microscope tracking positions during surgical procedures.
Compatibility
The Medtronic Navigation microscope bracket is compatible with Medtronic StealthStation™ S8 image-guided surgery systems and Medtronic navigation instruments.
System level manuals
This device can be used with Medtronic image-guided surgery systems. See the StealthStation™ system level manuals and cranial procedure pocket guides for descriptions of patient groups, intended users, potential clinical benefits, side effects, and potential complications.
Qualified microscopes
When used with the StealthStation™ S8 system with StealthStation™ S8 Cranial software, the Medtronic Navigation microscope bracket is qualified with the following Leica microscopes:
Leica M720 OH5
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Leica M530 OH6
Leica M530 OHX
Leica ARveo Leica ARveo
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1: Microscope bracket (9733883)
Warnings
Warning: Inspect the microscope bracket for damage and cleanliness before use. If
visibly damaged or unclean, do not use the microscope with the StealthStation™ system. Do not attempt to repair it.
Warning: Use care when handling the microscope. Do not allow the microscope
bracket to collide with anything.
Warning: If microscope bracket is damaged during the procedure, abandon use of
the microscope with the StealthStation™ system.
Warning: Frequently confirm localization accuracy and system responsiveness
during navigation. If accuracy degrades, re-register the patient. Refer to the StealthStation™ cranial pocket guides for instructions on how to re-register the patient.
Warning: When navigating with the microscope, keep the crosshair in the same
ocular that was used to calibrate the microscope.
Warning: The device is designed for re-use and is supplied non-sterile.
Warning: Use caution and exercise care in order to prevent injury during use. See
the corresponding system level manuals and procedure pocket guides for further handling instructions.
Warning: To avoid potential exposure to blood-borne pathogens and chemicals, use
appropriate Personal Protective Equipment when handling, processing, or disposing of Medtronic devices.
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Precautions
Caution: Federal law (U.S.A.) restricts this device to sale by or on the order of a
physician.
Caution: Use of the cable with no compatibility label may cause some video
distortion with the Leica ARveo 8.
Caution: Refer to the StealthStation™ system level manual and system procedure
pocket guides for additional instructions, warnings, and cautions.
Setting up equipment
1. Connect the cables.
If you are using the Leica M720 OH5, M530 OH6, or Leica ARveo microscope models, follow these steps:
a. Connect the serial interface of the StealthStation
communication cable to the EXTERN CAN (external CAN) serial port 1 on the Leica control unit.
b. Connect the video connector of the StealthStation™ S8 system microscope
communication cable to the Video Input port 2 in the Leica control unit.
c. Connect the latching push-pull LEMO™ interface of the StealthStation™ S8
system microscope communication cable to the LED LEMO located in the Leica control unit.
d. Connect the orange latching push-pull LEMO™ connector on the other end
of the StealthStation™ S8 system communication cable to the orange Microscope port 4 on the side panel of the StealthStation
e. Connect the gray latching push-pull LEMO™ connector on the other end of
the StealthStation™ S8 system communication cable to the Instrument B port 5 on the side panel of the StealthStation
Note: Your StealthStation™ S8 cart may not have all of the ports shown in the figure.
S8 system microscope
cable 3
S8 system.
S8 system.
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2: Leica M720 OH5, M530 OH6,or Leica ARveo connections to the StealthStation™ S8 system
1 External CAN serial port in Leica control unit 2 Video Input port in Leica control unit 3 LEMO 4 Microscope port on StealthStation 5 Instrument B port on StealthStation
If you are using the Leica M530 OHX microscope model, follow these steps:
a. Connect the serial interface of the StealthStation™ S8 system microscope
communication cable to the CAN (external CAN) serial port 1 on the Leica control unit.
b. Connect the video connector of the StealthStation™ S8 system microscope
communication cable to the Video Input (XGA) port 2 in the Leica control unit.
c. Connect the latching push-pull LEMO™ interface of the StealthStation™ S8
system microscope communication cable to the LED LEMO located in the Leica control unit.
d. Connect the orange latching push-pull LEMO™ connector on the other end
of the StealthStation™ S8 system communication cable to the orange Microscope port 4 on the side panel of the StealthStation
e. Connect the gray latching push-pull LEMO™ connector on the other end of
the StealthStation™ S8 system communication cable to the Instrument B port 5 on the side panel of the StealthStation
Note: Your StealthStation™ S8 cart may not have all of the ports shown in the figure.
cable in Leica control unit
S8 system
S8 system
S8 system.
(IGS) port 3
S8 system.
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3: Leica M530 OHX connections to the StealthStation™ S8 system
1 CAN serial port in Leica control unit 2 Video Input (XGA) port in Leica control unit 3 LEMO 4 Microscope port on StealthStation 5 Instrument B port on StealthStation
If you are using the Leica ARveo 8 microscope model, follow these steps:
Note: If you have multiple Leica microscopes, only use the cable with the
compatibility label on the Leica ARveo 8.
a. Connect the DVI end on the VGA-DVI adapter to the IGS IN port on the
Leica control unit and connect the interface cable with the compatibility label to the VGA port on the VGA-DVI adapter 1.
b. Connect the serial interface of the StealthStation
communication cable to the IGS CAN serial port 2 on the Leica control unit.
c. Connect the latching push-pull LEMO™ interface of the StealthStation™ S8
system microscope communication cable to the LED LEMO located in the Leica control unit.
d. Connect the orange latching push-pull LEMO
of the StealthStation Microscope port 4 on the side panel of the StealthStation
e. Connect the gray latching push-pull LEMO
the StealthStation port 5 on the side panel of the StealthStation
Note: Your StealthStation the figure.
(IGS) port on the Leica control unit
S8 system
S8 system
S8 system communication cable to the orange
S8 system communication cable to the Instrument B
S8 cart may not have all of the ports shown in
S8 system microscope
cable 3
connector on the other end
S8 system.
connector on the other end of
S8 system.
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