microtargeting_star_drive_directions_for_use_rev_c0.pdf
Page 1
™
microTargeting
i
microTargeting™
STar™ Drive System
Directions for Use
Including:
Motor/Encoder Assemblies
Controller/Display Module
Stereotactic Adapters
L011-1007
(Rev. C0, October 2010)
“Innovation through collaboration”
FHC, Inc.
1201 Main Street
Bowdoin, ME 04287
Fax +1-207-666-8292
Email: fhcinc@fh-co.com
L011-1007 Rev. www.fh-co.com
C0, October 2010
24 hour technical service:
1-800-326-2905 (US & Can)
+1-207-666-8190
FHC Europe
(TERMOBIT PROD srl)
129 Barbu Vacarescu Str,
Sector 2
Bucharest 020272
Romania
1
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
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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
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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
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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
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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
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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
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
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