STarTM Drive Platform Adapter Kit

Directions For Use

L011-44 (Rev. B3, October 2013)

Disclaimer: FHC, Inc. does not accept liability for injury or damage to equipment that may result from misuse of the STarTM Drive Platform Adapter Kit or its components. Federal law (USA) restricts this device to sale, distribution, and use by, or on the order of, a physician. Copyright© 2001-2009 FHC, Inc. All rights reserved.

Hardware Usage and Assembly Instructions

Use and Sterilization

Warnings are indicated by the following symbol:

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

24 hour technical service: 1-800-326-2905 (US & Can) +1-207-666-8190

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

2. 6mm Target Offset Mounting Hub 66-MP-TH 11. Combination Bit* 66-WP-CD

3. Standard Mounting Hub 66-MP-MH 12. 3mm Entry Offset Mounting Hub 66-MP-EH

4. Microtray for small parts* 13. Center Positioner 70-DP-CS

5. Hex Wrench 66-WP-HW 14. Offset Positioner 70-DP-OS

6. SteriSuite Case 15. Screwdriver Tool Z1-52-06

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.

Prevacuum Steam Sterilization: Preconditioning Pulses: 3 Minimum Temperature, Wrapped: 132° C Full Cycle Time: 8 minutes Minimum Dry Time: 40 minutes

Method

Platform

Platform Adapter Kit

(pictured on back)

Protocol

EO

Sterrad™ Sterrad™ 100S full cycle

Steam

Steam

Prevacuum Steam Sterilization Preconditioning Pulses: 3 Minimum Temperature, Wrapped: 132° C Full Cycle Time: 12 minutes Minimum Dry Time: 30 minutes

Preconditioning Set Points: Temperature: 54° C Relative Humidity: 40% Vacuum Set Point: 1.5 psia Preconditioning Time: 60 min

Wrapped Sterilization Parameters: Temperature: 54° C Relative Humidity: 40% EO Concentration: 725 mg/L Gas Exposure Time- (full cycle SAL 10-6): 120 minutes Aeration Time: 12 hours Aeration Temperature: 55±4° C

Gravity Steam Sterilization (Flash): Minimum Temperature, Unwrapped: 132° C Full Cycle Time: 10 minutes Minimum Dry Time: none

Gravity Steam Sterilization Minimum Temperature, Wrapped: 132° C Full Cycle Time: 30 minutes Minimum Dry Time: 35 minutes

Prevacuum Steam Sterilization Preconditioning Pulses: 3 Minimum Temperature, Wrapped: 132° C Full Cycle Time: 4 minutes Minimum Dry Time: 40 minutes

6 3

Track Selection

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)