For Research Use Only For Research Use Only

For Research Use Only For Research Use Only
Pin Type
Output
Output
Output
Output
Output
Power
Symbol
AOUT1
AOUT2
AOUT3
AOUT4
AOUT5
AGND_MST
7
Input
STIM TRIG
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
Input
Input
Power
Input
Input
Input
Input
Input
Input
Input
Input
Input
Output
Output
Output
Output
Output
Output
AUXDIN1
AUXDIN2
DGND
DIN0
DIN1
DIN2
DIN3
DIN4
DIN5
DIN6
DIN7
STROBEIN1
AOUT6
AOUT7
AOUT8
AOUT9
AOUT10
RECON
26
Output
STIMON
Output
STIMSYNC
Power
Input
Input
Input
Input
Input
Input
Input
Input
Input
DGND
DIN8
DIN9
DIN10
DIN11
DIN12
DIN13
DIN14
DIN15
STROBEIN2
27
28
29
30
31
32
33
34
35
36
37
Description
Earth Referenced Analog Output from Channel 1
Earth Referenced Analog Output from Channel 2
Earth Referenced Analog Output from Channel 3
Earth Referenced Analog Output from Channel 4
Earth Referenced Analog Output from Channel 5
Analog Ground for Channels AOUT1-AOUT5 (Master LP+)
External Stimulus Trigger (TTL level). User must be in Stim Mode to trigger
stimulation. Triggers on rising edge of pulse.
Auxiliary Digital input (TTL level) connected to Channel 1 of the Master LP+
Auxiliary Digital input (TTL level) connected to Channel 6 of the Sub-unit LP+
Digital Ground
Digital Input (TTL level) connected to Master channel 1
Digital Input (TTL level) connected to Master channel 1
Digital Input (TTL level) connected to Master channel 1
Digital Input (TTL level) connected to Master channel 1
Digital Input (TTL level) connected to Master channel 1
Digital Input (TTL level) connected to Master channel 1
Digital Input (TTL level) connected to Master channel 1
Digital Input (TTL level) connected to Master channel 1
Active low strobe input connected to Channel 1 and DIN0-DIN7
Earth Referenced Analog Output from Channel 6
Earth Referenced Analog Output from Channel 7
Earth Referenced Analog Output from Channel 8
Earth Referenced Analog Output from Channel 9
Earth Referenced Analog Output from Channel 10
Signal marking a record all event across all channels
Active low signal, stays low while stimulation is in process on any channel. Signal pulled high when idle.
Active low signal, marks the onset of each pulse in a stimulation train. The signal
remains low for a fixed duration of 130us.
Digital Ground
Digital Input (TTL level) connected to Sub-unit channel 6
Digital Input (TTL level) connected to Sub-unit channel 6
Digital Input (TTL level) connected to Sub-unit channel 6
Digital Input (TTL level) connected to Sub-unit channel 6
Digital Input (TTL level) connected to Sub-unit channel 6
Digital Input (TTL level) connected to Sub-unit channel 6
Digital Input (TTL level) connected to Sub-unit channel 6
Digital Input (TTL level) connected to Sub-unit channel 6
Active low strobe input connected to Channel 6 and DIN8-DIN15
DB37 connections on the ten-channel breakout box. See text for more details.
4
L011-57-01 (Rev A2, Jan. 2013)
www.fh-co.com
L011-57-01 (Rev. A2, January 2013)
The dual Guideline 4000 LP+TM system permits users to
combine two single LP+ units into one larger system, which
can support up to ten recording channels and four analog
input channels. This configuration requires the MT-LPP-BOX2
ten-channel breakout box, which transmits important
synchronization signals between the two systems to enable precise timing and control of the two individual
systems. The ten-channel breakout box also provides easy access to analog and digital input/output
connections on the dual LP+ system.
The implementation of the dual LP+ system requires the conversion of one standard LP+ system into a subunit LP+ system, which can only be used in the dual configuration. The master LP+
can be used as a stand-alone LP+ or as part of the dual configuration without requiring
reconfiguration.
Reference the microTargeting Guideline 4000 LP+ TM Directions for Use (L011-57, included with LP+
shipment) for proper use instructions, including important safety precautions and warnings.
Symbol Key
Ordering Information
MT-LPP: Guideline 4000 LP+ TM neuromodulation targeting system
MT-LPP-SUB: Upgrade kit for Guideline 4000 LP+TM to
sub-unit for dual LP+ system
For Research Use Only
Pin #
1
2
3
4
5
6
For Research Use Only
Pinout of DB37 connections on the ten-channel breakout box.
Directions for Use
for Dual Guideline 4000 LP+™
Digital ground
Master
system
Analog ground
MT-LPP-BOX2: Ten-channel breakout box for dual LP+ system
MT-LPP-CART: Cart for use with Guideline 4000 LP+TM
MT-LPP-CART-AC: Accessory cart brackets for use with dual LP+
system
Sub-unit
system
Breakout Box
Analog Output
WARNING: The dual LP+ system is not CE marked or FDA cleared as a medical device. Only use
the system on human patients if appropriate hospital and regulatory clearances are in place.
WARNING: Only use the dual LP+ system with the recommended FHC cart, or a suitable
replacement, with locking wheels and a stable, level surface to safely secure both systems.
WARNING: Only use FHC-recommended equipment, cables, and equipment accessories with the
dual LP+ system.
WARNING: Always perform the pre-use checkout procedure (see LP+ Directions for Use) on both
systems prior to use in a surgical case.
WARNING: Discontinue use of the Guideline 4000 LP+TM should any erratic function or damage
become evident.
WARNING: The Guideline 4000 LP+ TM dual system must be operated by a person who has been
trained by an FHC authorized representative and has read and understood the Guideline 4000 LP+ TM
directions for use (DFU).
WARNING: The Guideline 4000 LP+ TM dual system can be configured to allow externally initiated
stimulation. Always monitor patient response when using this feature to ensure safety.
WARNING: Restrict each Guideline 4000 LP+ TM to a single hemisphere. Never record
from both hemispheres using a single LP+ while both units are in use.
CAUTION: Keep the BNC protective covers in place on all unused BNC connections
on the LP+ and breakout box.
FHC, Inc.
1201 Main Street
Bowdoin, ME 04287
Fax: +1-207-666-8292
www.fh-co.com
24 hour technical service:
1-800-326-2905 (US & Can)
+1-207-666-8190
Email: fhcinc@fh-co.com
FHC Europe
(TERMOBIT PROD srl)
42A Barbu Vacarescu Str, 3rd Fl
Bucharest 020281 Sector 2
Romania
FHC Latin America
Carrera 43 A # 1sur 31
Ed. BBVA oficina 401
Medellín-Colombia
1. Assemble the dual Guideline 4000 LP+ TM system as shown.
a. Be sure to connect the master LP+ system to the master side of the breakout box, and the sub-unit LP+ system to
the sub-unit side of the breakout box – see decals on the breakout box and LP+.
b. The dual system must be used with the breakout box for the systems to be able to communicate with each other.
c. The sub-unit LP+ may only be used with the master LP+. The master LP+ may be used without the sub-unit LP+
for five-channel operation.
d. The ten-channel LP+ includes a split audio cable that enables both systems to be used with one pair of speakers.
This cable will direct sound from the master unit (channels 1-5) to the left speaker, and will direct sound from the
sub-unit (channels 6-10) to the right speaker.
e. The ten-channel system includes two stimulation remote controls. Stimulation on channels 1-5 is controlled with
the remote control attached to the master unit, and stimulation on channels 6-10 is controlled with the remote
control attached to the sub-unit.
2. Power up the dual LP+ system.
3. Perform the pre-use checkout procedure for both LP+ systems.
4. Load a user profile and enter patient information.
5. Perform microelectrode recording.
a. Analog outputs can be configured in the LP+ software to transmit raw (line noise filter only), processed (digital
filters and line noise filter), or enhanced audio (see LP+ help files for more detail) output.
b. Auxiliary digital inputs (AUXDIN1 and AUXDIN2) are linked to channels 1 and 6, respectively. In order to record
digital events on AUXDIN1, a recording must be in process on channel 1, and to record on AUXDIN2, a recording
must be in process on channel 6.
c. Digital inputs (DIN0-DIN15) can be used to capture two 8-bit digital words.
i.
By default, a timestamp is sent to the PC any time the digital input state changes on any of the pins, along
with the new state of each bit. In this configuration, STROBEIN1 and STROBEIN2 are non-functional.
ii.
The LP+ can be reconfigured so that digital input states/timestamps are captured only when the strobe
inputs are sent a logic low signal. Use STROBEIN1 for DIN0-DIN7, and STROBEIN2 for DIN8-DIN15.
Contact FHC to change this configuration.
iii. DIN0-DIN7 are linked to channel 1, and DIN8-DIN15 are linked to channel 6. To capture the information
on the DIN ports, a recording must be initiated on channel 1 for DIN0-DIN7 and on channel 6 for DIN8DIN15.
e. When a “Record All” event is initiated, the RECON pin will transition to a high logic state and stay high for the
duration of the recording.
f.
STIMON and STIMSYNC can be used to record stimulation onset/offset timing information. When stimulation is in
progress:
i.
STIMON will transition to a logic low at the initiation of stimulation on any channel and remain low for the
duration of stimulation. STIMON will remain high otherwise.
ii.
STIMSYNC will transition low to mark the onset of a stimulation pulse, and remain low for a fixed duration
of 130us. STIMSYNC remains high when not stimulating.
a. The dual LP+ system can be configured to allow externally triggered stimulation to occur. For safety reasons, the
system is shipped with this functionality disabled. Contact FHC to activate this feature.
i.
The STIM TRIG input can be used to trigger stimulation events with a TTL input pulse. Stimulation is
triggered on the rising edge of the input pulse.
ii.
The stimulation dialog box must be open to trigger stimulation.
iv. In triggered mode (default), stimulation will continue until a second TTL pulse is sent to the STIM TRIG
input. Stimulation will terminate on the falling edge of the second pulse. If the Fixed Duration or Train
Cycles boxes are checked, stimulation will continue for the duration/number of cycles indicated, regardless
of ensuing termination pulses. In this case, stimulation may be stopped by pressing the orange button on
the stimulation remote control.
iii. In gated mode, stimulation will continue as long as the STIM TRIG input is held high. However, if either of
the Fixed Duration or Train Cycles boxes are checked, stimulation will continue for the duration/number of
cycles indicated, even if the STIM TRIG input is returned to a logic low. In this case, stimulation may be
stopped by pressing the orange button on the stimulation remote control.
6. Identify the implantation site.
7. Save patient data.
8. Shut down the dual Guideline 4000 LP+TM system.
L011-57-01 (Rev A2, Jan. 2013)
www.fh-co.com
2
System Components
1. Notebook computer
2. microTargetingTM (mT) Controller
module
3. mT Controller remote control
4. mT Controller motor or encoder
15
assembly
5. Inline serial–to-USB converters
6. Stimulation remote control
(channels 1-5)
7. Speakers
8. Split audio cable for dual LP+
9. microTargetingTM (mT) Controller
14
module
10. mT Controller remote control
11. mT Controller motor or encoder
assembly
12. Stimulation remote control
13
(channels 6-10)
13. Ten-channel breakout box for dual
LP+ system
14. mT electrode cable for LP+ (sold
separately as 66-EL-LP)
15. USB cables
1
2
3
4
5
6
7
8
9
For Research Use Only
Reference the Guideline 4000 LP+ TM Directions for Use and Guideline 4000 LP+TM help files for more detail on usage of
the system.
For Research Use Only
Abbreviated Procedure
10
11
12
BNC Connection
Description
1-10
Earth Referenced Analog Output from Channel 1-10, ±1.5 V AC-coupled.
AUXDIN1
Auxiliary Digital input (TTL level) connected to Channel 1 of the Master LP+
AUXDIN2
Auxiliary Digital input (TTL level) connected to Channel 6 of the Sub-unit LP+
RECON
Digital output signal (TTL level) marking a “Record All” event (includes all active channels)
STIMSYNC
STIMON
STIM TRIG
Active low output signal (TTL level), marks the onset of each pulse in a stimulation train. The signal
remains low for a fixed duration of 130us.
Active low output signal (TTL level), stays low while stimulation is in process on any channel. Signal
pulled high when idle.
External stimulus trigger input (TTL level). User must be in Stim Mode to trigger stimulation.
Stimulation triggers on rising edge of pulse and triggers a stimulation event according to current
parameters set in software.
BNC connections on the ten-channel breakout box.
3
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