Monteris Medical Neuroblate User manual

Instructions
for Use

NeuroBlate® System Instructions for Use
80469 Rev D – Nov 16, 2018
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INSTRUCTIONS FOR USE
CAUTION – Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.
Carefully read all instructions prior to use. Observe all contraindications, warnings, and cautions
noted in these directions. Failure to do so may result in patient complications.
TABLE OF CONTENTS
TABLE OF CONTENTS.............................................................................................................................................. 2
1. SYSTEM DESCRIPTION................................................................................................................................... 6
1.1. NEUROBLATE®SYSTEM DESCRIPTION..................................................................................................................6
1.2. NEUROBLATE OPTIC LASER DELIVERY PROBE &PROBE DRIVER DESCRIPTIONS .........................................................11
1.2.1. Laser Delivery Probes (LDP) .................................................................................................................11
1.2.2. SideFire® Optic 3.3 Directional Laser Probe .........................................................................................13
1.2.3. FullFire® Optic Diffusing Tip Laser Probes............................................................................................14
1.2.4. Laser Delivery Probe Selection .............................................................................................................15
1.2.5. Advanced Probe Driver (APD) and Robotic Probe Driver (RPD) ...........................................................16
1.3. OPERATING MODES .......................................................................................................................................19
2. INDICATIONS FOR USE ................................................................................................................................ 20
3. CONTRAINDICATIONS................................................................................................................................. 21
4. WARNINGS, CAUTIONS, & SAFETY REQUIREMENTS.................................................................................... 22
4.1. IDENTIFICATION LABELS ..................................................................................................................................22
4.2. EQUIPMENT LABELS .......................................................................................................................................23
4.3. GENERAL WARNINGS .....................................................................................................................................25
4.3.1. Electronics Rack Warnings...................................................................................................................28
4.3.2. Advanced Probe Driver, Robotic Probe Driver and LDP Warnings .......................................................29
4.4. GENERAL CAUTIONS.......................................................................................................................................30
4.4.1. NeuroBlate® System.............................................................................................................................30
4.4.2. Laser Delivery Probes, Advanced Probe Driver and Robotic Probe Driver ...........................................32
4.5. GENERAL SAFETY REQUIREMENTS.....................................................................................................................32
4.6. LASER SAFETY ...............................................................................................................................................32
4.7. INSPECTION,CLEANING,DISINFECTION,STERILIZATION .........................................................................................33
4.8. OPERATING CONDITIONS ................................................................................................................................33
4.9. STORAGE CONDITIONS....................................................................................................................................33

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5. MRI CONDITIONAL STATUS......................................................................................................................... 34
5.1. MR IMAGE ARTIFACT ................................................................................................................................36
6. POTENTIAL HARMS OR HAZARDS ............................................................................................................... 38
7. NEUROBLATE® SYSTEM SETUP.................................................................................................................... 39
7.1. MRI PROTOCOLS AND DICOM IMAGE TRANSFER SETUP ......................................................................................39
7.2. CO2TANKS..................................................................................................................................................43
7.3. MRI SHIELD PENETRATION FOR NEUROBLATE CABLING ........................................................................................45
7.4. NEUROBLATE SYSTEM CONTROL WORKSTATION: ................................................................................................47
7.4.1. Software Boot Up and Launch Screen..................................................................................................48
7.5. NEUROBLATE SYSTEM M*VISION™SOFTWARE APPLICATION................................................................................49
7.5.1. Workflow Task Icons and Description..................................................................................................50
7.5.2. Main Menu Bar Options.......................................................................................................................51
7.5.3. Toolbar and System Status Description ...............................................................................................52
7.5.4. Hardware Interfaces ............................................................................................................................54
7.5.5. MR Thermal Data Transfer ..................................................................................................................54
7.5.6. Initiating Data Transfer Interface ........................................................................................................54
7.5.7. Thermal Monitoring Slice Planes .........................................................................................................55
8. NEUROBLATE® SYSTEM PROCEDURE WORKFLOW...................................................................................... 57
8.1. PROCEDURE PRE-PLANNING ............................................................................................................................57
8.1.1. M*Vision Software Start Screen ..........................................................................................................57
8.1.2. Load and Register Image Data within Plan Register Task ...................................................................58
8.1.3. Create Region of Interest (ROI) Volumes within the Plan Volumes Task .............................................61
8.1.4. Create Intended Trajectories within the Trajectory Task .....................................................................63
8.1.5. Saving a Plan........................................................................................................................................65
8.1.6. Opening a Saved Plan ..........................................................................................................................66
8.2. OPERATING ROOM:PRE-PROCEDURE PREPARATION ............................................................................................67
8.2.1. Sterile Probe Delivery Platform ............................................................................................................67
8.2.2. Anesthesia............................................................................................................................................67
8.2.3. Head Fixation.......................................................................................................................................67
8.2.4. Image-Guided Surgery (IGS) System Registration (Non-Sterile) ..........................................................67
8.2.5. Prepping and Sterile Draping for Trajectory Guidance Devices ...........................................................68
8.2.6. Image-Guided Surgery (IGS) Registration - Sterile ...............................................................................68
8.2.7. Laser Delivery Probe (LDP) Platform Attachment ................................................................................68
8.2.7.1. Skull-Mounted Trajectory Devices such as AXiiiS Stereotactic Miniframe ...........................................68
8.2.7.2. Skull Bone Anchor ................................................................................................................................68
8.2.8. Create a Pathway to the Intended Target ...........................................................................................69
8.2.9. Laser Delivery Probe (LDP) Depth Stop and Size Determination..........................................................70
8.2.9.1. AXiiiS Stereotactic Miniframe - Depth Stop and Size ...........................................................................70
8.2.9.2. Skull Bone Anchor such as Monteris Mini-Bolt - Depth Stop and Size..................................................71
8.3. PREP FOR TRANSFER TO MRI...........................................................................................................................74
8.4. INTERFACE PLATFORM (IP) ATTACHMENT/DETACHMENT–TABLE OR ATAMASTABILIZATION SYSTEM............................74
8.5. TRAJECTORY CONFIRMATION AND BEAM FIDUCIAL MARKER DETECTION ..................................................................85
8.5.1. Scan and Register Data in M*Vision using Plan Register Task ............................................................86
8.5.2. Create Region of Interest (ROI) Volumes within Plan Volumes Task....................................................86
8.5.3. Create Trajectories within Trajectories Task for AXiiiS ........................................................................87
8.5.4. Create Trajectories within Plan Trajectories Task – without AXiiiS......................................................87
8.5.5. Identify Ball Marker Selection within the Align Task ...........................................................................88

NeuroBlate® System Instructions for Use
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8.6. SELF-TEST,PROBE DRIVER ATTACHMENT AND LDP INSERTION...............................................................................90
8.6.1. Final Trajectory Adjustment in Insert...................................................................................................90
8.6.1.1. AXiiiS Workflow....................................................................................................................................90
8.6.1.2. Non-AXiiiS Workflow............................................................................................................................92
8.6.2. Probe Driver (APD and RPD) Attachment and Connections (if Applicable)..........................................93
8.6.3. Laser Delivery Probe (LDP) Size Selection and Insertion.......................................................................99
8.7. MRI CONFIRMATION OF LDP INSERTION .........................................................................................................110
8.8. THERMAL DELIVERY AND MONITORING IN TREAT WORKFLOW TASK......................................................................113
8.8.1. ENABLE THE MRI FOR REAL TIME TRANSFER.....................................................................................114
8.8.1. Position Thermal Monitoring Planes in M*Vision..............................................................................121
8.8.2. Thermal Sequence Prescription on the MRI .......................................................................................124
8.8.2.1. GE Thermal Sequence Prescription Procedure ...................................................................................125
8.8.2.2. Philips MRI Thermal Sequence Prescription Procedure......................................................................132
8.8.3. Initiate Thermal Monitoring in M*Vision...........................................................................................135
8.8.3.1. For Philips MRI Only (for all other MRI types skip to 8.8.3.2) ............................................................135
8.8.3.2. Initiate Thermal Monitoring for all Other MRI Types.........................................................................137
8.8.3.3. Initiate Delivery of Laser Energy to Tissue .........................................................................................142
9. ELECTRICAL RACK REQUIREMENTS AND TECHNICAL DATA ....................................................................... 150
10. TECHNICAL SUPPORT ................................................................................................................................ 155
11. CONTACT INFORMATION.......................................................................................................................... 156
11.1. DISTRIBUTOR/REP CONTACT: ........................................................................................................................156
11.2. MANUFACTURED BY: ...................................................................................................................................156
12. TIPS AND TROUBLESHOOTING.................................................................................................................. 157
Patent Notice under 35 U.S.C. §287(a): Monteris Medical products and associated processes are subject
to the United States patents and pending applications.
NeuroBlate, Monteris Medical, SideFire, FullFire, AXiiiS, AtamA, AutoLITT, Monteris Mini-Bolt, the M
Logo, the N Logo, the A Logo and M*Vision Pro are trademarks of Monteris Medical. © Copyright
Monteris Medical 2018. All rights reserved.

NeuroBlate® System Instructions for Use
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Anesthesia
AtamA
(Head Fixation Setup)
Draping / Sterile Field
AXiiiS Attachment
AXiiiS Trajectory
Alignment
Set Initial Probe Insertion
Depth
Load Image Data
Volume Definition
Trajectory Definition
Load Image Data and
Registration
AXiiiS (Fiducial Marker)
Detection
Set Maximum Probe
Depth (PDP)
System Self Test
Laser Foot Pedal
Check
Adv. Probe Driver (APD)
Attach and Check
Probe Attach, Check and
Insertion
MRI Scan for Probe
Placement
Load Image Data
Adjust
SW Rendered Probe to
Artifact
MRI Real Time Transfer
Setup
Begin Real Time
Measurements
Temperature Calculation
Setup (Ref Points)
Thermal Dose Monitoring
End Lasing
Move Patient from MRI
Bore
Remove Probe and APD
Close Patient
Move APD – Probe
Linear Travel
Move APD – Probe
Rotation
Remove AXiiiS
(Pre) Planning
Next Trajectory
Next Probe Movement - Linear
NeuroBlate
Procedure
Overview
Patient Placement in MRI
MRI Trajectory Confirm
(Wand)
Procedure Flowchart
Color Key
Manipulation of a Monteris Device
MRI Image Acquisition
Surgical Team Patient Management
Software Worflow Steps
Flowchart 1: NeuroBlate® System Procedure Overview
Delivery Platform
(AXiiiS) Attachment
and IGS Alignment
or
Stereotactic System
Alignment and Delivery
Platform (Bolt)
Attachment
AXiiiS
Workflow
Pre-Op or
in Parallel
Mini-Bolt
Workflow

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1. System Description
1.1. NEUROBLATE®SYSTEM DESCRIPTION
The Monteris NeuroBlate® System enables MRI-guided neurosurgical ablation. The NeuroBlate
System hardware and disposable accessories are outlined in Table 1.1.
Table 1.1: NeuroBlate System Product List
Component
Catalog
Number
Description
Other Information
NeuroBlate System
NB102
For use with Siemens, IMRIS, GE, or Philips MRI
Interface Platform
Resides behind the patient head during
MR thermal imaging to manage the
electronic connections for the Probe
Driver and Laser Delivery Probe as well
as the cooling connection.
MRI Conditional
(1.5T/3.0T)
System Electronics Rack
and Components
A rolling cabinet which resides in an
equipment area adjacent to the MRI
containing the system control
computers, electronic hardware, laser
light source and CO2cooling
components.
MR Unsafe
Control Workstation
containing M*Vision Pro
Software
A system workstation which resides in
the MRI control area and includes a
laser foot pedal, keyboard, mouse and
display for the graphic user interface
MR Unsafe
NeuroBlate Advanced
Probe Driver (APD)
NBD-01
Control device to manage linear
translation and rotational manipulation
of the Laser Probe during the NB
procedure. Attaches to the Interface
Platform and AXiiiS.
MRI Conditional
(1.5T/3.0T)
Sterile
Single Use Only
NeuroBlate Robotic Probe
Driver (RPD)
RPD-01
Lower profile Control device to manage
linear translation and rotational
manipulation of the Laser Probe during
the NB procedure. Attaches to the
Interface Platform and appropriate
bone anchors.
MRI Conditional
(1.5T/3.0T)
Sterile
Single Use Only

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Component
Catalog
Number
Description
Other Information
SideFire® Optic 3.3
Directional Laser Probe
#000 (133mm)
#00 (154mm)
#1 (175mm)
#2 (196mm)
#3 (217mm)
#4 (238mm)
#5 (259mm)
NBP-000-01
NBP-001-01
NBP-101-01
NBP-201-01
NBP-301-01
NBP-401-01
NBP-501-01
Gas-cooled, directional laser delivery
probe (LDP) used to deliver controlled
energy to the intended target zone.
The appropriate probe length is
determined by the M*Vision software.
3.3mm Outside Diameter
MRI Conditional
(1.5T/3.0T)
Sterile
Single Use Only
FullFire® Optic 3.3
Diffusing Tip Laser Probe
#000 (133mm)
#00 (154mm)
#1 (175mm)
#2 (196mm)
#3 (217mm)
#4 (238mm)
#5 (259mm)
DTP-000-01
DTP-001-01
DTP-101-01
DTP-201-01
DTP-301-01
DTP-401-01
DTP-501-01
Gas-cooled, diffusing laser delivery
probe (LDP) used to deliver thermal
energy in all directions from the probe
tip to the intended target zone.
The appropriate probe length is
determined by the M*Vision software.
3.3mm Outside Diameter
MRI Conditional
(1.5T/3.0T)
Sterile
Single Use Only
FullFire® Optic 2.2
Diffusing Tip Laser Probe
#000 (133mm)
#00 (154mm)
#1 (175mm)
#2 (196mm)
#3 (217mm)
#4 (238mm)
#5 (259mm)
FFS000-01
FFS002-01
FFS122-01
FFS222-01
FFS322-01
FFS422-01
FFS522-01
Smaller Diameter, Gas-cooled, diffusing
laser delivery probe (LDP) used to
deliver thermal energy in all directions
from the probe tip to the intended
target zone.
The appropriate probe length is
determined by the M*Vision software.
2.2mm Outside Diameter
MRI Conditional
(1.5T/3.0T)
Sterile
Single Use Only

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Monteris Medical also offers an array of optional disposable and reusable devices (Table 1.2)
which can be used for Laser Probe delivery and skull anchoring as well as head stabilization.
These devices are not required for the use of the NeuroBlate System, but have been validated
to work properly with the NeuroBlate System.
Table 1.2: Optional Products Validated for Use with the NeuroBlate System
Item
Catalog
Number
Description
Other Information
AXiiiS® Stereotactic
Miniframe
AX300-01
MRI Visible, Stereotactic Mini-Frame for
trajectory alignment, and guidance of
NeuroBlate Laser Delivery Probe.
MRI Conditional
(1.5T/3.0T)
Sterile
Single Use Only
Instrument Adapter
IA300-01
Set of three reducing tubes (1.9, 2.2,
and 2.6mm) designed to guide
neurosurgical devices (Example: a
biopsy needle) through the AXiiiS
Stereotactic Miniframe Directional
Interface.
MRI Safe
Sterile
Single Use Only
MRI Trajectory Wand
MW300-01
MRI visible, fluid-filled tube, which
when placed into the AXiiiS Stereotactic
Miniframe allows confirmation of AXiiiS
alignment to target along the intended
trajectory.
MRI Safe
Sterile
Single Use Only
Monteris® Mini-Bolt
CMB033
CMB022
The Monteris® Mini-Bolt assembly is
a disposable, rigid skull fixation
device designed to provide a stable
platform to deliver neurosurgical
devices or instruments.
MRI Conditional
(1.5T/3.0T)
Provided Non-Sterile
Single Use Only
AtamA® Stabilization
System
ATB002-XX
MR compatible head fixation device for
patient immobilization and transfer.
MRI Conditional
(1.5T/3.0T)

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The NeuroBlate System is compatible with only the following 1.5T or 3.0T MRI systems.
•Siemens - minimum software versions VB17, VB19, VD13, VE11
oSymphony (1.5T)
oAvanto (1.5T)
oTrio (3.0T)
oEspree (1.5T)
oVerio (3.0T)
oAera (1.5T)
oSkyra (3.0T)
•IMRIS NEURO II (1.5T) or NEURO III (3.0T) - Siemens MRI software versions listed above
•GE - minimum software version 12.X, 15.X to 26.X
oSigna HDx/HDxT (1.5T & 3.0T)
oOptima MR450/450W (1.5T)
oDiscovery MR750/750W (3.0T)
oSigna Artist (1.5T) software version 26.X - using 16-channel GE Flex Coil
•Philips – software version R3, R4, R5
oAchieva (1.5T & 3.0T)
oIngenia (1.5T and 3.0T)

NeuroBlate® System Instructions for Use
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Figures 1.1 and 1.2 below depict the set-up of NeuroBlate System within the MRI suite.
* Note, at the HCP request, the Electronics Rack can also be co-located in the MRI Control Room
Figure 1.1: Typical Layout of the NeuroBlate System within the MRI Suite
Figure 1.2: NeuroBlate Components in the MRI Environment
MRI Scan
Room
*MRI
Equipment
Room
MRI Control
Room
Interface
Platform
Electronics
Rack
Control
Workstation
Laser Delivery Probe inserted into
the Monteris Mini-Bolt
Probe Driver
Mounted on
Interface Platform
Head Stabilized
in AtamA
System