This document is posted to help you gain knowledge. Please leave a comment to let me know what you think about it! Share it to your friends and learn new things together.
Intended Use The microTargeting™ Platform is intended for use with the STar™ Drive.
The microTargeting™ Platform is used in conjunction with the STar™ Drive System and does not change its Indications For Use: The STar™ Drive System is intended to be used for neurosurgical procedures which require the accurate positioning of microelectrodes, stimulation electrodes, or other instruments in the brain or nervous system.
Compatibility The microTargeting™ Platform is to be used with the STar™ Drive and the WayPoint™ Anchor Locator Systems. Use with non-compatible components or systems is not authorized and may result in mechanical failure or injury.
Sterilization Adapter and drive components are to be wiped thoroughly with disinfectant, scrubbed, and wiped clean with a distilled water cloth before sterilization is performed. Do not allow excessive moisture to remain on the devices.
The microTargeting™ Platform is shipped non-sterile and must be sterilized before use. Invert the Platform on its hub surface with the legs pointing up during sterilization.
Users should be aware that the effects of unvalidated sterilization protocols could result in damage to the components and affect their functioning or performance. The microTargeting™ Platform is not validated for use with alternative sterilization protocols, and FHC does not recommend or endorse their use. Users with questions regarding this safety issue should contact FHC’s Technical Service Department at 1-207-666-8190.
www.fh-co.com
FHC Europe (TERMOBIT PROD srl) 42A Barbu Vacarescu Str, 3rd Fl Bucharest 020281, Sector 2 Romania
FHC, Inc. 1201 Main Street Bowdoin, ME 04287 USA Fax: +1-207-666-8292 www.fh-co.com
FHC Latin America Carrera 43 A # 1sur 31 Ed. BBVA oficina 401 Medellín-Colombia
The Target Offset Hub creates a new trajectory with target area orthogonally offset 6mm from the original at the Microelectrode tip depth when the physical Drive reads 30mm. For Platforms with T<>30, the offset of 0.69mm per 10mm of Drive travel may be used to determine position at target depth.
3.5 3.0
2.12 2.0
1.41 1.0 .71
3.5
3.0
2.12 2.0
1.41 1.0 .71
3.5
3.0
2.1
2
2.0
1
.41
1
.0
.71
3.5
3.0
2.1
2
2.0
1
.41
1
.0
.71
Offsetting Chart
The Entry Offset Hub creates a new trajectory which is orthogonally offset 3mm from original at approximate entry depth, and coincides with the original at the microelectrode tip depth when the physical Drive reads 30mm. For Platforms with T<>30, the offset of 0.34mm per 10mm of Drive travel may be used to determine position at target depth.
Pure
Water
Rinse
Ecolab Inc.
detergent
(2.5 ml/l or 1/4 oz/gal)
Inventory
6
15
1
12 7
2 3
8 16
4
11 10 9
5
14 13 18 17
* Contents of microtray: Combination Bit / 66-WP-CD, Array Carrier / 70-AC-AR, spare Platform hardware ** Purchased separately, see STar Drive DFU L011-1007 for more information.
Note that the indexing rings will not be needed if the surgeon has chosen an integrated ring platform model.
Manual Cleaning
Items Covered Protocol
1. Prepare the detergent according to manufacturer’s recommendations:
Asepti Wash Plus liquid (2.5 ml per liter or 1/4 oz per gal), using warm
tap water.
2. Separate the Drive, positioners, hubs, rings, and Lead Holder and
immerse them in the wash solution for a minimum of 5 minutes.
Actuate the devices during the soak.
3. Using a clean soft cloth that has been soaked in the detergent, wipe the
tray, and its insert, to remove any visible soil. Use a soft bristle brush
and syringe to reach hard-to-clean areas.
4. Place the Drive and its components back in the tray.
5. Prepare the detergent in a sonication unit according to manufacturer’s
recommendations: Asepti Wash Plus liquid (2.5 ml per liter or 1/4 oz
per gal).
6. Immerse the tray in the sonication unit and sonicate for a minimum
of 10 minutes.
7. Rinse all components with running reverse osmosis/de-ionized water
to remove any residual detergent.
8. Dry components using a clean soft cloth.
9. Visually inspect to ensure all visible soil is removed.
STar™
SteriSuite
case
needed
(6)
Drive and adapter kit *
Indexing Rings (1)
Mounting Hubs
(2, 3, 12)
Wrenches (5, 9)
Measuring Fixture (7)
Tools (8, 15)
Manual Handle (10)
Combination Bit (11)
Positioners (13,14)
Verification Probe (16)
STar™ Drive M/E with
cover removed
OR STar™ Drive (17)
Lead Holder (18)
Refer to page 6 for the components identified with numbers, listed below. *
Automated Cleaning - Use tray with disassembled components (page 6)
Items Covered Protocol
Phase Recirculation
Time (min)
Water
Temperature
Ecolab Inc.
detergent
(2.5 ml/l or 1/4 oz/gal)
Pre-
Wash 1
Enzyme
Wash
Wash 1
Rinse 1
Dry
Phase
2:00
2:00
2:00
2:00
0:10
7:00
Cold Tap Water
(16°C max)
Hot Tap Water
(43°C min)
65.5°C
(Set Point)
Heated Water
(66.0°C)
Heated
(66.0°C)
115°C
N/A
N/A
N/A N/A
N/A
N/A
Asepti Wash Plus
Asepti Wash Plus
Asepti Rinse
Sekusept AR
Sekusept AR
Sekusept FNZ or
Sekumatic Multiclean
2 7
1. Indexing Ring (two provided) 66-MP-IR 10. Manual Handle 66-MP-DH
7. Lead measurement fixture 66-AC-MT-01 16. Verification Probe SUB19-11
8. Entry Marking Tool 66-MP-EM 17. STar Drive** 70-ZD-ME
9. Standoff Wrench 66-WP-SW 18. Lead Holder** 70-CN-DB
STar™
SteriSuite
case
needed
(6)
Drive and adapter kit *
Indexing Rings (1)
Mounting Hubs
(2, 3, 12)
Wrenches (5, 9)
Measuring Fixture (7)
Tools (8, 15)
Manual Handle (10)
Combination Bit (11)
Positioners (13,14)
Verification Probe (16)
STar™ Drive M/E with
cover removed
OR STar™ Drive (17)
Lead Holder (18)
Platform:
1. Insert two thumbscrews into each indexing ring. Any 2 of the 4 screw holes on the indexing ring may be used, as long as the two holes are 90 degrees apart. Ensure that the thumb-screws go completely through the indexing ring, but that they do not protrude into the hub area. Be careful of cross threading the tapped screw holes. If the platform does not have integrated rings, attach an indexing ring to each platform opening.
2. Attach the center hub to the indexing ring. Tighten the indexing ring screws by hand.
3. Ensure that the hub is completely seated in the indexing ring. The hub should not rock or move. The hub will sit approximately 1/8” above the top surface of the indexing ring (slightly higher if using the offset hubs.)
Patient:
1. Position the patient using a non-invasive restraint system and drape the sterile field.
2. Expose and inspect anchors for looseness and anchor sites for infection. The surgeon’s judgment determines if anchors are secure and safe to continue.
Surgical Preparation
Equipment Setup
1. Attach the platform to the anchors. Use the entry marker tool to mark the skin. Remove the platform then expose the skull.
2. Re-attach the platform. Use the entry marker tool to mark the skull. Remove the platform then drill the burr hole.
3. Re-attach the platform once appropriate additional components have been attached. See relevant component instruction manuals for additional information.
4. Once the procedure is complete, remove all components from the platform. Ensure that indexing ring screws are removed before the platform is discarded. If difficulty is encountered when removing the platform, insert a second thumbscrew into the hub 180 degrees from the first. Pulling straight up on both screws simultaneously should allow the hub to disengage from the platform easily.
3mm Offset Positioner in the ‘G’ position, indicated by the dark blue dots in the figure below.
3mm Offset Positioner in the ‘B’ position, indicated by the magenta dots in the figure below.
Offsets beyond the 10mm range of the Positioner may be reached with the Target Offset Hub.
Center positioner (9 distinct tracks): Center track on target. Four parallel tracks with 2mm offset, ‘+’ configuration, using positions A,C,E and G. Four parallel tracks with 2mm offset, ‘x’ configuration, using positions B,D,F and H. Examples:
Center Positioner, ‘+’ configuration, using any of positions ACE or G, indi-cated by the black dots in the figure below.
Center Positioner, ‘X’ con-figuration, using any of positions BDF or H, indi-cated by the red dots in the figure below.
3mm offset positioner (40 distinct tracks): Five parallel tracks with 2mm offset, center track offset 3mm from origin, in eight configurations using positions A-H. Examples:
CCBB AA
206.74mm
A
M
N
O
Drive at Zero
30 mmTarget Drive at Target
Target
AA Insertion Tube BB Stylet CC Spacer Tube for tungsten microelectrodesDD Spacer Tube for Pt/Ir microelectrodesEE Tungsten microelectrodes Spacer cleaning Rod FF Pt/Ir microelectrodes Spacer cleaning Rod
GG Array Electrode CarrierHH Shielded Array ClampII Non shielded Array ClampMM Non Sterile Single tungsten mT electrode 44930RNN Single Electrode pin position in slot
(Dimensions may vary for other Platform models)
Single Electrode Platform configuration
MA Drive shown with 120mm model mT platform
319mm
40CM Lead Implant
Drive at Zero Drive at Target
Macro -Contact1 mm
120
mm
Ø 0.55 mm
Ø 0.99/1.5 mm
10 mm
27 mm
10 mm
AA
CCBB
EE
66-IT-03
20
.2
05101520253035404550
.90 .8.1
05101520253035404550
.90 .8.1.2
DD
GG
HH
II
BACK
FRONT
1
234
5
HH
II
NN 66-AC-ARTOPVIEW
SIDEVIEW
FF
27 mm
DD
Ø 1.60/1.83 mm
MM MM
LL
SBBSCC
26 mm
10 mm
TargetTarget
SA STar Array Locking Carrier w/ 2 extra screwsSB STar Array Hex WrenchSC STar Array Wire ToolSAA STar Array Platform Insertion Guide TubeSBB STar Array Platform Electrode Insertion Tube SCC STar Array Platform Electrode Insertion Tube StyletSDD STar Array Insertion Tube ExtractorSEE Array Platform Electrode pin positions in slotsKK Array Platform Lead Insertion Tube LL Array Platform Lead Insertion Tube StyletMM Array Platform microelectrode # 44970R
L012
-mT
Plat
form
-DIM
CHA
RT S
TAR
DRIV
E PL
ATFO
RM
-082
012
STar Array Electrode Platform configuration
M/E Drive shown with 120 mm model Platform
26 mm
Ø 0.55 mm
Ø 1.60/1.83 mm
Ø 0.60/0.90 mm
Macro -Contact1 mm
KK
206.
74 m
m
Ø 1.83 mm
SAA
Drive at Zero
30 mm
Drive at Target
.2
Drive at Zero Drive at Target
120
mm
05101520253035404550
.90 .8.1
05101520253035404550
.90 .8.1.2
0.2 .1 .9 .80.2 .1 .9 .8
24 mm
A Verification Probe M Lead Holder 70-CN-DBN Measuring Fixture 70-AC-MT-01O Depth Stop Adapter (1.8 mm) 66-AC-DS(1.8)
Ordering information66-AC-AR Non Sterile Array Carrier and Clamp Includes GG, HH, II66-IT-03P Sterile Single Insertion Tube Set Includes AA, BB, CC66-IT-03 Non Sterile Single Insertion Tube Set Includes AA, BB, CC, DD, EE, FF44970R Sterile Tungsten Platform mT Electrode (pk 5)44975Z Sterile Tungsten Platform mT Electrode D.ZAP (pk 5)44975L Sterile Tungsten Platform mT Elec. D.ZAP Leadpoint (pk 5)mTDPBN(BP)(MP1) Non Sterile Pt/Ir Platform Single mT Electrode (pk 6)
SBBSCC
KKLL
2ea SDD
Non Sterile70-IT-04
SAA
BACK TOPVIEW
SIDEVIEW
SA
SB
70-AC-AR4
FRONT
1
2
3
5
SEE
3 ea SC
Ordering information70-IT-AR5P Sterile STar Array Electrode Insertion Tube (pk 5) includes 5ea SAA, 5ea SBB, 5ea SCC66-IT-AR4P Sterile Lead Insertion Tube (pk 5) includes 5ea KK, 5ea LL70-CN-ET Sterile STar™ Array Insertion Tube Extractor (pk 5) includes 5 ea SDD70-IT-04 Non Sterile STar Array Electrode Insertion Tube Set for mT Platform includes 6ea SAA, 6ea SBB, 6ea SCC, 1ea LL, 1ea KK, 2 ea SDD70-AC-AR STar Array Locking Carrier includes 1ea SA (w 2 spare screws), 1ea SB, 3ea SC44970R Sterile Array Tungsten Platform mT Electrode (pk 5)44975Z Sterile Array Tungsten Platform mT Electrode D.ZAP (pk 5)44975L Sterile Array Tungsten Platform mT Electrode D.ZAP Leadpoint (pk 5)