microTargeting STar Drive Directions for Use Rev C0 Oct 2010

Page 2

2

microTargeting™ STar™ Drive System Directions for Use

Page 3

Contents

4

5

6

7

7-9

10-11

12-13

13-15

16

17-18

19

20

21-27

28-37

38-48

49

Warnings and Cautions, Symbols

Storage, Cleaning

Sterilization

Maintenance and Calibration

Pre-Use Assembly and Checkout

Motor/Encoder Accessories: Sterile Draping

Motor/Encoder Accessories: Mounting the Draped Assembly

Motor/Encoder Accessories: Controller/Display Module

Mounting the Drive on the Stereotactic System

Preparing the 40cm Lead for Implant

STar™ Drive System Components

Single, Array and Lead Components

Single Electrode Insertion Tube Set Procedure

Array Electrode Insertion Tube Set Procedure

Frame Adapters

Warranty and Service

Directions for Use of the STar™ Drive M/E and Manual version are similar. Illustrations herein show the M/E

version with accessories. Manual drive users should disregard the sleeved motor shown in pictures and any

instructions labeled with

.

L011-1007 Rev. C0, October 2010

3

Page 4

microTargeting™ STar™ Drive System,

Accessories and Stereotactic Adapters

Indications for use: The microTargeting™ STar™ Drive System is intended to be used with commercially available

stereotactic systems for neurosurgical procedures which require the accurate positioning of microelectrodes, stimulating

electrodes, or other instruments in the brain or nervous system.

Contraindications: Follow the general guidelines concerning the suitability of neurosurgery involving the insertion of electrodes,

instruments or devices.

Warnings

WARNING: If any error or erratic function is observed, discontinue use of the Drive System immediately and evaluate

the potential impact to patient safety before continuing its unmitigated use.

WARNING: Prior to use, the microTargeting™ STar™ Drive System should be completely assembled and correct operation verified to ensure that all components function properly. Improper set-up of equipment may lead to serious patient

injury.

WARNING: Always confirm the tightness of thumbknobs, especially those holding the frame adapter, before beginning

the procedure. The stereotactic adapter must be securely held in the frame mount so that the drive system cannot move

or rotate.

Cautions

CAUTION: The microTargeting™ STar™ Drive M/E System Motor and Encoder Accessories are specifically designed to be

used with the microTargeting™ STar™ Drive M/E. Use with other components or systems is not authorized and may result

in mechanical failure or injury.

CAUTION: Federal law restricts this device to sale by or on the order of a physician.

CAUTION: FHC’s regulatory clearance requires that microTargeting™ STar™ Drive Systems and components be serviced

and recalibrated every 100 uses or factory evaluated on an annual basis.

CAUTION: Do not use non-approved stereotactic system adapters, insertion tubes or other medical or electronic devices

with the microTargeting™ STar™ Drive System.

CAUTION: Handle the Drive and, when applicable, its Motor and Encoder Accessories with extreme care. These

components may be damaged if excessive force or incorrect handling occurs.

CAUTION: The Drive System and its associated insertion tubes are not MRI compatible.

CAUTION: When tightening the STar™ Array Locking Carrier screws that are difficult to reach by hand, use only the tool

provided. When tightening all other screws and thumbknobs, hand tighten only. Overtightening can cause damage to the

Drive System and adversely affect targeting.

Symbol Key

Warnings should be read carefully because if they are not heeded they could lead to situations which may result in

serious injury or death.

c

Rx Only

Zero

Hand Tighten Securely

Retract

Off/On

Remote Control

Assembly (Power Assist or Display)

Advance

o

4

Serial Communications Port

Type BF Equipment

(electrically isolated from patient)

Retract to Zero

s

Sterile

microTargeting™ STar™ Drive System Directions for Use

JNon-sterile

Page 5

Storage

Store the microTargeting™ STar™ Drive System and,

when applicable, the Motor/Encoder Accessories at

temperatures between –34°C (-29°F) and 57°C (135°F).

Do not exceed 135°F for long-term storage.

Cleaning

CAUTION: The cover is provided to protect the

opening of the STar™ Drive M/E when an accessory is

not attached. Failure to use the cover could allow debris

to enter the drive mechanism. The cover should be

removed during cleaning and sterilization to allow

proper drainage from this mechanism.

In the event any Motor or Encoder Assembly or Module

becomes contaminated or soiled it should be disconnected

from power sources and wiped clean with an isopropyl

alcohol dampened cloth, then dried. Do not immerse Motor

or Encoder in fluids or allow excessive moisture to remain.

* Refer to system diagram on pages 19-20 for the components identified with letters, listed below.

Method

Manual

Cleaning

STar™

SteriSuite

case

needed

(L)

Items Covered

Drive and its

Components

*

STar™ Drive M/E with

cover removed (J)

STar™ Drive (I)

Lead Holder (M)

Electrode

Depth Stops

(O, Y, X, SA, SB)

Measuring Fixture (N)

Frame Adapter

(S, T, U, V, YY, ZZ)

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, stereotactic adapter, 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.

Verification Probe (A)

Insertion Tubes

and Spacer Tubes

(AA, BB, CC, KK, LL,

SAA, SBB, SCC, SDD)

Automated

Cleaning

Drive and its

Components

ONLY

STar™

SteriSuite

case

needed

STar™ Drive M/E with

cover removed (J)

(L)

*

STar™ Drive (I)

1. Immediately following use, thoroughly rinse each tube and other components separately

under tap water. Repeatedly insert the Stylet or Spacer Tube cleaning tool in and out of

the tube under running tap water to dislodge any debris or coagulated fluid.

2. Soak all components in wash solution, then repeat step one (as above) then rinse in

distilled water.

3. Insertion Tubes, Spacer Tubes, and Stylets MUST be steam sterilized as separate items

(not assembled).

Ecolab Inc.

detergent

Ecolab GmbH

detergent

(2.5 ml/l or 1/4 oz/gal)

(2.5 ml/l or 1/4 oz/gal)

Cold Tap Water

(16°C maximum)

N/A

N/A

2:00

Hot Tap Water

(43°C minimum)

Asepti Wash

Plus

Sekusept AR

Wash 1

2:00

65.5°C

(Set Point)

Asepti Wash

Plus

Sekusept AR

Rinse 1

2:00

Heated Water

(66.0°C)

N/A

N/A

Pure Water

Rinse

0:10

Heated

(66.0°C)

Asepti Rinse

Sekusept FNZ or

Sekumatic Multiclean

Dry Phase

7:00

115°C

N/A

N/A

Recirculation

Time (min)

Water

Temperature

Pre-Wash 1

2:00

Enzyme Wash

Phase

Lead Holder (M)

Electrode

Depth Stops

(O, Y, X, SA, SB)

Measuring Fixture (N)

Frame Adapter

(S, T, U, V, YY, ZZ)

Verification Probe (A)

L011-1007 Rev. C0, October 2010

5

Page 6

Sterilization

WARNING: None of the Drive Accessories should be sterilized; use the sterile draping system as described

on pages 10-11.

WARNING: The use of unvalidated sterilization protocols could result in damage to components and affect

their functioning or performance.

Method

Steam

Steam

Container

STar™

Drive

Tubes

3

3

Protocol

Prevacuum (Wrapped)

Gravity (Wrapped)

preconditioning pulses: 3

minimum temperature: 132°C (270°F)

full cycle time: 12 min

minimum dry time: 30 min

minimum temperature: 132°C (270°F)

full cycle time: 30 min

minimum dry time: 35 min

Prevacuum (Wrapped)

Gravity (Unwrapped)

preconditioning pulses: 3

minimum temperature: 132°C (270°F)

full cycle time: 4 min

minimum dry time: 20 min

minimum temperature: 132°C (270°F)

full cycle time: 10 min

Following sterilization, before reassembling the Drive System, use a cloth dampened with sterile distilled water to wipe off

surfaces to prevent residue build up. The system should be examined after each sterilization cycle for damage and function.

6

microTargeting™ STar™ Drive System Directions for Use

Page 7

Maintenance and Calibration of the Drive

All components of the Drive should be thoroughly cleaned, then rinsed with distilled water following each use. None of the

system’s moving parts require lubrication. Do not oil or lubricate.

Before each use, thoroughly examine the microTargeting™ STar™ Drive System for function, cleanliness, and

calibration. Any noticeable change in accuracy, in ease of movement, or any buildup of residues, looseness, damage,

or difficulty of fitting components will require return to the manufacturer for refurbishing and recalibration.

Pre-Use Assembly and Checkout

STar™ Drive M/E

1. Confirm there are no contaminants or debris

on the Drive. Turn both knobs separately,

confirm that the Drive screw rotates and that

the electrode platform moves. Confirm that

there are no stiff spots, skipping, free play or

backlash present when turning the knob.

Confirm that the knob(s) turn easily without

excessive resistance.

WARNING: If any error or erratic function

is observed, discontinue use of the Drive

immediately and evaluate the potential

impact to patient safety before continuing

its unmitigated use.

WARNING: While often snug, all tubes used

with the microTargeting™ STar™ Drive

System have been designed to be inserted

and removed by hand or by using the STar™

Extraction Tool. (see below) Any other tool

should be used only as a last resort and

indicates system repair may be necessary.

WARNING: Do not use the STar™ Insertion

Tube Extractor with any other tube than the

STar™ Array Insertion Tube.

L011-1007 Rev. C0, October 2010

STar™ Drive

2. Confirm all thumbknobs are present.

7

Page 8

Pre-Use Assembly and Checkout (continued)

4. Inspect the Insertion Tubes.

3. If using the 40cm lead, test mount the

Lead Holder on the carriage, confirm

there are no stripped threads or

looseness.

8

WARNING: As the most critical component

of a procedure, delicate Insertion Tubes

should always be carefully inspected

before use because damage to them can

cause targeting errors and impact patient

safety. Handle Insertion Tubes and Spacer

Tubes carefully to prevent bending.

WARNING: Check to be certain that tubes

are straight; with the collar over the edge,

roll the Insertion Tube over a flat surface or

in the Measuring Fixture slot.

microTargeting™ STar™ Drive System Directions for Use

Page 9

Pre-Use Assembly and Checkout (continued)

6. Install the Verification Probe onto the positioning

platform; tighten the locking screw. When the

stereotactic system and the Drive are set up

correctly, the tip of the Verification Probe will be

exactly at the predicted target. If the stereotactic

system used has a phantom, confirm the targeting

coordinates at this step. If not, proceed.

WARNING: The verification probe should

never enter the brain.

5. Secure the Stereotactic Adapter to the

Drive. (See pages 38-46 for appropriate

type.)

7. Remove the Verification Probe.

L011-1007 Rev. C0, October 2010

9

Page 10

Motor/Encoder Accessories: Sterile Draping

Draping the Assembly can be accomplished by one person, but is facilitated if an assistant is present. The oneperson method will require a sterile gloved hand ( s )

for the drape. The other hand will be a non-sterile hand

(J

) after handling the module. Most will find that the

module hand should be the least favored hand. A practice

draping should be done before first surgical use.

1.

3.

J: Holding the non-sterile assembly with the

pins pointing away from you, and the coiled cable in

the same hand, slide it into the drape, being careful

not to touch the outside of the drape.

4.

s : Push the drape over the Jhand

so the assembly and cable are all the way at the

end of the sleeve. Note that the draping process

results in the alignment and motor drive pins, which

are non-sterile, protruding from the sterile drape.

J(or prior to putting on sterile gown and

gloves): Remove the protective storage cap from

the Coupling Unit. To remove any debris, wipe the

alignment and center drive pins with an isopropyl

alcohol dampened, lint free cloth or wipe. Coil the

assembly’s cable and place it on a flat surface so

that it can be picked up with its cable in one hand.

WARNING: After draping the accessories, do not

touch the mounting or drive-plate pins against

any sterile field elements. These pins should

only be allowed to contact the top of the STar™

Drive M/E, and will be inaccessible when fully

assembled.

5.

2.

10

and J

: Maneuver the drape and assembly so that the two alignment pins and the center

drive plate are entering the cutouts in the end of the

drape.

s

s : Remove the drape from its sterile packaging and expand the opening to allow entry of a

hand. Do not pull any of the folds out at this time.

(If one person, remove the included elastic bands

from their tape holder and place on a sterile surface.)

microTargeting™ STar™ Drive System Directions for Use

Page 11

Motor/Encoder Accessories: Sterile Draping (continued)

9.

6.

s and J: Push the pins and

the center drive plate through the cutouts

and smooth the stretchable end of the

drape over the assembly.

7. Take the elastic bands and stretch them over the

assembly, using at least two wraps. Be careful to

smooth any wrinkles from the mating flat surface

of the assembly as this is done. Do not touch the

pins or drive plate. Ensure the wraps are above

the flanges on the assembly to prevent slipping.

8.

J: Unfold the drape carefully as the cable

is withdrawn. When the cable is out of the sterile

envelope distance, the Jhand can hold

both the cable and the drape.

10.

s : Using the tape that the elastic bands

came in, pull in the folds of the drape tightly

above the assembly and tape neatly. If no assistant is helping, this can be done after changing

the non-sterile glove.

11.

J: The assembly cable can be plugged

into its receptacle, or

s

: The whole draped apparatus set aside

on a sterile surface awaiting the surgery. In this

case, it is best to leave the cable inside the drape

and to not unfold the drape more than necessary

until it is needed.

s : Hold the drape with the assembly inside

while Jhand pulls the cable from the drape.

Be careful not to touch the pins protruding from the

end of the drape.

L011-1007 Rev. C0, October 2010

11

Page 12

Motor/Encoder Accessories: Mounting the Draped Assembly

1. Remove the protection cover of the Drive.

4. When the pins are felt to engage, gently

push the Assembly all the way down to the

top cover of the Drive. Make sure no folds

of the sterile drape are caught between

surfaces.

2. Pick up the assembly and insert the two long

alignment pins slightly into the holes in the top

cover. There is no incorrect way to align the pins.

Do not force the assembly any further at this time.

3. Push down lightly on the Assembly while turning

the Drive advancement knob slowly.

Since the center drive plate of the Encoder Assembly, if used, turns so easily it may be necessary to pull it away from the turning plate in the

Drive slightly and push down lightly several times

before alignment occurs. Do not attempt to force

engagement as damage to the mechanism can

occur.

12

WARNING: Always confirm the Encoder

or Motor Assembly seats squarely on the

Drive. A misalignment may result in a stall.

(See page 15.)

CAUTION: Never turn the manual advancement knob on the microTargeting™ STar™

Drive M/E while a motor is engaged. This

can damage both the motor and the Drive.

CAUTION: Pre-use check should include

retracting or advancing the Drive Motor

using the handheld remote. Confirm that

the knob can be turned to its clockwise

(advance) and counterclockwise (retract)

limits and when released returns to the

center position. No movement of the Drive

should occur when the remote control

knob is in the center resting position. If

there are any abnormalities, perform the

calibration procedure. (See page 15.)

microTargeting™ STar™ Drive System Directions for Use

Page 13

Motor/Encoder Accessories:

Controller/Display Module

WARNING: Position connecting cables and

leads where they will not be inadvertently

pulled or tangled.

WARNING: Do not operate the controller unit

in the presence of flammable anesthetics.

WARNING: Do not connect simultaneously an

Encoder Assembly and a Remote Control into

the microTargeting™ Controller or this will

result in display errors.

5. Tighten the Assembly locking knobs securely

and test the Assembly for secure attachment

and operation.

CAUTION: The accessory components

should be inspected visually prior to each

use for physical damage, frayed or kinked

cables or damaged connectors.

1. It is assumed at this point that either the Encoder or

Motor Assembly is draped and attached to the Drive.

● Ensure the power supply’s line cord is plugged

into a power outlet.

● Connect the Assembly to the Module by inserting

its connector into the corresponding socket on the

front panel labeled with the following symbol.

● If using the Motor Assembly, connect the Remote

Control to the Module front panel mating connector

labeled with the following symbol.

● Connect the power supply to the Module (back

panel).

CAUTION: Alternative power supplies and

sources are not authorized for use with this

equipment and may cause malfunction or injury.

L011-1007 Rev. C0, October 2010

13

Page 14

Motor/Encoder Accessories: Display/Controller Module (continued)

2. Activate the ON/OFF switch in the back panel of the

Module.

CAUTION: If the Retract to Zero button on the Remote Control is inadvertently pressed for at least

5 seconds before the next step, the Module will go

into its Remote calibration mode. The calibration

procedure described on page 15 must be followed

before the Remote will function normally.

● For the Encoder Assembly, advance or retract the

Drive using the advancement knob.

● For the Motor Assembly, turning the Remote Control knob clockwise advances the Drive towards

the target, turning the knob counterclockwise

retracts the Drive away from the target location.

The further the knob is turned, the faster the Drive

will advance or retract. Full clockwise position will

advance the Drive at the highest possible speed,

full counterclockwise position will retract the Drive

at highest possible speed.

● If there is any movement of the Drive when the

Remote Control knob is in the center (resting) position, follow the calibration procedure on page 15.

WARNING: Be careful when moving the Drive

above the zero mark or below 50mm prior to

pressing the zero button. It is possible to move

the Drive into its physical limits. Carefully observe travel direction when using the Remote

Control before the Drive is zeroed. After the

Drive is zeroed, the Controller will not allow

movement beyond the Drive limits of 0.00 and

50.0mm.

CAUTION: Never turn the manual advancement

knob on the microTargeting™ STar™ Drive M/E

while a motor is engaged. This can damage

both the motor and the Drive.

3. If a Motor is used, set the Drive to zero by using

the remote control. If an Encoder is used, turn the

advancement knob to zero. Press the zero button,

labeled , (front panel on the Module) to set the LED

display to 00000μm.

WARNING: Always confirm that the microTargeting™ STar™ Drive M/E is set at 0mm when

zeroing the microTargeting™ Controller. (As

a safety feature, the Display Unit cannot be

re-zeroed without powering off the Module.)

Not doing so will cause the Drive limit to be

incorrect and also will cause the Controller

Display to be out of sync with the drive position as read on the drive scale.

CAUTION: Do not zero the Display Unit until

prompted. Failure to do so will result in display errors.

4. When the Drive is advanced, the position report on

the LED will be updated and will show either the

real distance traveled from the zero position, or the

distance from the target location depending on the

distance mode. Distance is shown in microns or

millimeters, depending on the operator’s preference. The arrow symbol in front of the position

number indicates direction of travel or will point to

the position readout at rest.

WARNING: In the event of any Drive Accessory failure, erratic function or motor stall,

remove it and proceed using the microTargeting™ STar™ Drive M/E manually.

WARNING: During the procedure, periodically compare the physical scale depth reading with Controller reading to ensure proper

operation. If the two scales differ by more

than 25 microns, discontinue use of the

Display Unit and proceed manually.

WARNING: The microTargeting™ Controller

has been factory set to enforce a software

drive limit of 50mm which corresponds with

the maximum travel of the microTargeting™

STar™ Drive M/E. This limit may be changed

through the serial interface of the microTargeting™ Controller. However, setting

the limit beyond 50mm could result in drive

travel beyond the range of the Drive.

14

microTargeting™ STar™ Drive System Directions for Use

Page 15

Motor/Encoder Accessories: Display/Controller Module (continued)

Remote Control Calibration (If needed)

With the motor assembly and remote control connected

and the power on, press on the Retract to Zero button on

the Remote Control for at least 5 seconds to enter the calibration menu. The display will show “REMOTE CALIBRATION...ADVANCE”.

Turn the knob in the fully clockwise position then while

holding the knob in the full clockwise position, press and

release the retract to zero button. The display will show

“RETRACT”.

Turn the knob all the way counterclockwise and hold it

while pressing the Retract to Zero button.

This calibration procedure may need to be repeated

several times.

Check again for correct function, and if any errors are

noted the units should be returned to FHC for service.

microTargeting™ Controller Stall

Detection

In the event of a stall, make certain there is no physical

obstruction.

A stall algorithm has been provided so that if a stall is

detected during Drive movement, the word “STALL” will

appear on the display, and the Drive will stop moving

for approximately 5 seconds to alert the operator that

a stall has occurred. Then the position number will be

redisplayed and the Drive will continue moving at the

speed controlled by the remote.

The number displayed should be checked against the

Drive’s physical scale. A small discrepancy of less than

25 microns is not a cause for concern.

Discrepancies of over 25 microns or frequent stall warnings indicate repair is necessary. In order to complete

the procedure, disconnect accessories and proceed

using the manual advancement knob.

FHC should be contacted for service or repair.

L011-1007 Rev. C0, October 2010

15

Page 16

Mounting the Drive on the Stereotactic System

Mount the assembled system onto the stereotactic

system and secure it as shown on pages 38-46.

Make sure the securing screws are tight to prevent

movement or rotation. Confirm that the Drive mounts

securely on the frame mount.

WARNING: Always confirm the tightness

of thumbknobs, especially those holding

the frame adapter, before beginning the

procedure. The stereotactic adapter must

be securely held in the frame mount so

that the STar™ Drive System cannot move

or rotate.

WARNING: The Motor/Encoder should be

attached to the Drive before it is mounted

on the stereotactic system to avoid

exposing the assembly mounting

pins to the patient sterile field.

16

microTargeting™ STar™ Drive System Directions for Use

Page 17

A - Measuring Fixture

B - Depth Stop Adapter (1.8mm)

C - Lead Holder

Lead (not shown)

A

B

Note: Preparation should be done

in a sterile area.

C

3. Place the Depth Stop Adapter (1.8mm)

loosely on the lead.

1. Attach the Lead Holder to the Measuring

Fixture.

4. Insert the lead and Depth Stop Adapter

(1.8mm) into the Lead Holder.

2. Secure the Lead Holder to the Measuring

Fixture.

L011-1007 Rev. C0, October 2010

5. Secure the Depth Stop Adapter (1.8mm).

17

Page 18

Preparing the Lead for Implant (continued)

6. Position the lead contact area at the end

of the Measuring Fixture.

9. Remove the Lead Holder and lead with

preattached Depth Stop Adapter (1.8mm)

from the Measuring Fixture.

7. Tighten the lead.

WARNING: Do not over tighten this

screw as it may damage the lead.

10. Remove the Depth Stop Adapter (1.8mm)

from the Lead Holder, and set aside in a

sterile area for later use.

8. Loosen the Lead Holder.

18

microTargeting™ STar™ Drive System Directions for Use

Page 19

microTargeting™ STar™ Drive System - Stereotactic frame configuration

A Verification Probe,

66-IT-VP

B Positioning platform

C Electrode carrier locking screw

D Drive advancement knob (upper)

E Drive advancement knob (lower), M/E version only

F Stereotactic positioner locking knob

G Lower Guide (for 70-ZD-ME only) 70-LG-01

H Lower guide locking knob, M/E version only

70-ZD-MA

I STar Drive manual

J STar Drive Motor/Encoder

70-ZD-ME

66-CN-BR

K Cleaning brushes

67-00-7

L STar Steri Suite

70-CN-DB (includes M,O)

M Lead Adapter

N Lead measurement fixture

70-AC-MT

66-AC-DS(1.8)

O 1.8 mm Depth Stop Adapter

P Protection Cover, M/E version only

Q Accessory locking knobs, M/E version only

Ordering information FHC - Medtronic

I

STar Drive Manual

70-ZD-MA

STar™ Offset Frame Adapter

for Radionics CRW ™

ZZ

T

D

O

PP

QQ

RR

SS

TT

UU

WW

XX

O

Spare knobs

M

STar™ Frame

Adapter for

Radionics CRW ™

Drive Motor and Encoder Accessories

J STar Drive Motor/Encoder

70-ZD-ME

STar™ Frame Adapter

for Leksell

Stereotactic System

M

Power Assist with Display Assembly (motor)

Position Display Assembly (encoder)

Power Assist Controller/Display Module

Power supply

Power Cord

Remote Control

Sterile Drapes Sleeves

Storage Case

66-DA-ME

66-DA-EN-02

66-EL-MS

66-EL-RM

66-DA-SD

66-DA-SC

Spare

knobs

Encoder Option - Ordering information

P

with Lower Arm Bushing

S

Q

B

C

66-DS-PD

66-DA-SD

includes QQ, RR, SS, TT, XX

Sterile pack/20 WW

FC1007

FC1004

includes QQ, RR, SS, TT, XX

Sterile pack/20 WW

WW

XX

H

TT

POWER ASSIST

MODULE

E

REMOTE

CONTROL

ZERO

Targeting Controller

TM

F

RR

340

330

320

310

300

290

280 270

260

250

U

360 350

V

STar™ Offset Frame

Adapter for Leksell

Stereotactic System

370

STar™ Frame Adapter STar™ Frame Adapter

Leibinger RM™

for Leibinger ZD™

L

N

A

QQ

SS

YY

TT

K

POWER ASSIST

MODULE

REMOTE

CONTROL

ZERO

Targeting Controller

TM

RR

SS

microTargeting™ STar™ Drive System ordering information:

ST-DS-MA includes I, A, K, L, N

ST-DS-ME includes J, A, K, L, N

70-FA-LX

70-FA-RD

70-FA-RM

70-FA-ZD

70-FA-LX-01

70-FA-RD-01

70-FA-SF

Targeting

Remote Control

TM

PP

WW

G

Optional Equipment

G Lower Guide (for use with 70-ZD-ME only), 70-LG-01

See reverse for Insertion Tube and microelectrode Sets:

Single and Array

UU

L011-1007\pg 19&20 (Rev. C0, October 2010)

Frame Adapters - one needed but not included - Ordering Information

S STar™ Frame Adapter for Leksell Stereotactic System w/ lower arm bushing,

T STar™ Frame Adapter for Radionics CRW™

U STar™ Frame Adapter Leibinger RM™

V STar™ Frame Adapter for Leibinger ZD™

YY STar™ Offset Frame Adapter for Leksell Stereotactic System

ZZ STar™ Offset Frame Adapter for Radionics CRW ™

STar™ microTargeting Platform Adapter Kit (not shown)

XX

Motor Option - Ordering information

66-DS-PA

66-DA-SD

includes PP, RR, SS, TT, UU, XX

Sterile pack/20 WW

FC1008

FC1004

includes PP, RR, SS, TT, XX

Sterile pack/20 WW

19

Page 20

Single Electrode frame configuration

66-IT-01 Non Sterile

Ordering information

70-AC-01

Non Sterile STar Single Electrode

Carriers includes 2ea Y

66-IT-01

Non Sterile Single Electrode

Insertion Tube Set includes AA,

BB, CC, DD - Standard tube ends at

40 mm above target. See table with

additional lengths

66-IT-01P Sterile Single Electrode Insertion

Tubes includes AA, BB, CC (pk 5)

40 mm above target

FC1011

Non Sterile Single Electrode Insertion

tube Kit includes X, Y, AA, BB, CC, DD

FC1002

Non Sterile single mT electrode (pk 5)

34680

Sterile single mT electrode (pk 5)

AA

BB

CC

DD

70-IT-AR Non Sterile

AA

BB

CC

DD

70-AC-01

Y

Cat #

Y

Distance to Target (mm)

66-IT-01

66-IT-09

66-IT-13

66-IT-05

66-IT-07

66-IT-14

66-IT-08

Shielded Single Electrode Carrier

STar Single Electrode Carrier

Single mT electrode Medtronic # 34680

FHC # mTDWBP(BP)(BP7)

Insertion Tube (66-IT-01 shown)

Stylet

Spacer Tube

Spacer Cleaning Rod

40cm Lead Implant

Ordering information

70-IT-AR

Non Sterile STar™ Array Electrode Insertion Tube

Set includes 6ea SAA, 6ea SBB, 6ea SCC,

2 ea SDD, 1ea LL, 1ea KK

70-IT-ARP Sterile STar™ Array Electrode Insertion Tube (pk 5)

includes 5ea SAA, 5ea SBB and 5ea SCC

FC1019

Sterile lead Insertion tube (pk 5) includes

5ea KK, 5ea LL

70-CN-ET Sterile STar™ Array Insertion Tube Extractor (pk 5)

includes 5ea SDD

70-AC-AR STar™ Array Locking Carrier

includes 1ea SA (w/ 2 spare screws), 1ea SB

FC1003

Non Sterile Array mT Electrode (pk 5)

22670

Sterile Array mT Electrode (pk 5)

SDD

40mm

30mm

25mm

20mm

15mm

10mm

At Target

TOP

VIEW

BACK

O

SEE

SA

70-AC-AR

1

2

5

SB

4

3

FRONT

MA Drive shown with STar™ Frame Adapter for

Leksell Stereotactic System S

Drive at Zero

Drive at Target

SIDE

VIEW

SAA

SBB

M

SA

SB

SAA

SBB

SCC

SDD

SEE

KK

LL

MM

STar™ Array Locking Carrier w/ 2 extra screws

STar™ Array Hex Wrench

STar™ Array Insertion Guide Tube

STar™ Array Electrode Insertion Tube

STar™ Array Electrode Insertion Tube Stylet

STar™ Array Insertion Tube Extractor

Array Electrode pin positions in slots

Array Lead Insertion Tube

Array Lead Insertion Tube Stylet

Array microelectrode Medtronic # 22670

FHC # mTDWBP(AR)(AR2)

M/E Drive shown with STar™ Frame Adapter

for Leksell Stereotactic System S

SCC

LL

Z

X

KK

LL

SAA

SBB

SCC

Drive at Target

Drive at Zero

KK

Y

MM

BB

AA

CC

.2 .1 0 .9 .8

.2 .1 0 .9 .8

.2 .1 0 .9 .8

.2 .1 0 .9 .8

0

5

10

15

20

25

30

35

40

45

50

0

5

10

15

20

25

30

35

40

45

50

0

5

10

15

20

25

30

35

40

45

50

0

5

10

15

20

25

30

35

40

45

50

Ø 1.83 mm

375 mm

Ø 1.60/1.83 mm

Ø 0.77 mm

Ø 1.60/1.83 mm

N

Ø 0.55 mm

.2

Ø 0.99/

1.5 mm

0

.9 .8

S

Ø 0.60/0.90 mm

STar™ Frame Adapter

for Leksell

Stereotactic System

262.5 mm

S

.1

.2

.1

0

.9 .8

262.5 mm

X

Y

Z

STar™ Array Electrode frame configuration

Ordering information

FHC - Medtronic

with Lower Arm Bushing

S

Macro Contact

1 mm

188.5 mm

188.5 mm

28 mm

A

40 mm

10 mm

28 mm

Drive at Zero

10 mm

Drive at Zero

40 mm

30 mm

Drive at Target

Target

Target

20

(Dimensions may vary for other adapters)

30 mm

Target

Drive at Target

Target

L011-1007\pg 19&20 (Rev. C0, October 2010)

10 mm

Macro Contact

1 mm

Page 21

Single Electrode Insertion Tube Set Procedure

Position the Insertion Tube

WARNING: The Insertion Tube will enter the

brain at this stage.

WARNING: Never move the Insertion Tube in

the brain without a Stylet or electrode inside.

WARNING: When there is an Insertion Tube

in the brain, every effort should be made to

minimize lateral forces to the microTargeting™

STar™ Drive System as it can translate into

significant lateral movements of the tube in

the brain.

1. Adjust the Drive to zero; use the remote

control if a motor is attached, otherwise

turn the knob.

Directions for Use of the STar™ Drive M/E and

Manual version are similar. Illustrations herein

show the M/E version with accessories. Manual

drive users should disregard the sleeved motor

shown in pictures and any instructions labeled

with

.

2. Insert the Insertion Tube and Stylet in the

desired track.

2a. The Insertion Tube and Stylet are

inserted.

L011-1007 Rev. C0, October 2010

21

19

Page 22

Position the Microelectrode

5. Insert the Electrode Carrier, making sure

the holes align with the bushing holes.

3. Remove the Stylet.

6. Secure the Electrode Carrier.

15mm

4. Insert the Spacer Tube.

7. Retract the microelectrode 15mm.

4a. The Insertion Tube and Spacer Tube are

inserted.

20

22

microTargeting™ STar™ Drive System Directions for Use

Page 23

Establish Electrical Connections

and Begin Microelectrode Recording

WARNING: Improper cable connections

may cause erroneous results including

unintended stimulation through metal

contacts in the brain.

8. Insert the microelectrode in the Carrier

and the Spacer Tube until the microelectrode stop comes flush to the

Carrier.

10. Establish electrical connections and

advance the Drive. Use the remote control

if a motor is attached, otherwise turn the

knob.

9. Secure the microelectrode in the Carrier;

push the microelectrode down.

CAUTION: Do not over tighten this screw

as it may damage the microelectrode.

11. Begin recording.

12. Confirm the anatomical areas.

L011-1007 Rev. C0, October 2010

23

21

Page 24

Removing Electrodes

13. Remove electrical connections and

loosen the Carrier Locking Screw.

14. Remove the microelectrode and the

Carrier.

22

24

15. Remove the Spacer Tube.

16. Additional tracks are available and

require the Insertion Tube to be

removed, and steps 1-15 repeated.

microTargeting™ STar™ Drive System Directions for Use

Page 25

Begin the 40cm Lead Implant

19. The lead is inserted into the tube.

17. Attach the Lead Holder to the Drive

positioning platform.

20. Confirm the lead location. Use the remote

control if a motor is used, otherwise turn

the knob.

WARNING: Observe the exposed

segment of the lead while

advancing the Drive and ensure it

advances into the Insertion Tube

without binding or bending.

18. Insert the preset lead into the tube and

secure the Depth Stop Adapter (1.8mm)

in the Lead Holder.

L011-1007 Rev. C0, October 2010

25

23