Directions for Use
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™ 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: [email protected] 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
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microTargeting™ STar™ Drive System Directions for Use
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
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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
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.
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microTargeting™ STar™ Drive System Directions for Use
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.
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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.
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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
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.
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. 1. 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.
: Maneuver the drape and as5. s and J sembly so that the two alignment pins and the center drive plate are entering the cutouts in the end of the drape.
2. 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.)
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microTargeting™ STar™ Drive System Directions for Use
Motor/Encoder Accessories: Sterile Draping (continued)
: Unfold the drape carefully as the cable 9. J is withdrawn. When the cable is out of the sterile envelope distance, the Jhand can hold both the cable and the drape. 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.
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.
8. 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.
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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
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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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.
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microTargeting™ STar™ Drive System Directions for Use
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
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.
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microTargeting™ STar™ Drive System Directions for Use
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).
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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.
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microTargeting™ STar™ Drive System Directions for Use
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 Power Assist with Display Assembly (motor) QQ Position Display Assembly (encoder) RR Power Assist Controller/Display Module SS Power supply TT Power Cord UU Remote Control WW Sterile Drapes Sleeves XX Storage Case
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
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 L011-1007pg 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
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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
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
Cat #
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
40mm 30mm 25mm 20mm 15mm 10mm At Target
Y
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 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
L011-1007pg 19&20 (Rev. C0, October 2010)
10 mm Macro Contact 1 mm