Blackrock Research Assemblies

Transcription

Instruction for Use (IFU)
Electrophysiology, Simplified.
Blackrock Microsystems, LLC
630 Komas Drive · Suite 200
Salt Lake City · UT 84108
T: (801) 582-5533
www.blackrockmicro.com
[email protected]
LB-0514 2.00 Blackrock Research Assemblies IFU
© 2014 Blackrock Microsystems™, LLC
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1. Introduction
The Blackrock Research Assemblies are all powered by the Utah Array. Blackrock Research Assemblies are siliconbased, multi-electrode arrays that can be implanted in both in-vivo and in-vitro research applications. The main
purpose of the Blackrock Research Assemblies is to record/stimulate neural bio-potential activity in a specified
subject area of research. Unlike depth electrodes, which penetrate deep into the brain, Blackrock Research
Assemblies penetrate only the outer surface of the brain and are capable of detecting single unit and multi-unit
neuronal activities, as well as local field potentials. Some applications of the Blackrock Research Assemblies
include use in the peripheral nervous system, cardiovascular, digestive, respiratory, immune/lymphatic, urinary,
and muscular systems.
The different types of assemblies powered by Blackrock Research Assemblies are:
Name
CerePort
ICS-96
Omnetics
Dimensions
16.5mm (height)
19mm (diameter base)
11mm (diameter body)
18mm (height)
7mm (base length)
37mm (base width)
9mm (height)
7mm (base length)
13mm (base width)
Testing Type
Chronic
Acute
Chronic
Examples of Blackrock Research Assemblies types are shown in Section 4 “How to Interpret the Datasheet Sent
with Your Array Assembly” below.
2. Cautions
•
•
DO NOT let any instruments touch the electrodes as they can break easily. The Blackrock Research
Assemblies are delicate structures and can be damaged if not handled gently.
DO NOT perform Scanning Electron Microscope (SEM) imaging on samples prior to implantation as this will
alter and possibly degrade the array assembly causing the device to malfunction.
DO NOT user any sterilization techniques that are not recommended by Blackrock Microsystems. Some
sterilization methods can damage or degrade the array performance. Please refer to Section 5 for
sterilization recommendations.
DO NOT handle the electrode array directly with fingers.
•
DO NOT ultrasonically clean the electrode array. This will damage the array.
•
•
3. Unpacking
3.01
Unpacking of the Array Assembly
To unpack the array assembly, remove the screws securing the connector to the box. See Figure 1 for
mounting screws location. Carefully spread the foam to release the array and the connecting wires, and
remove the unit from the box. Make sure the array and wires (wire bundle, Reference and Ground)
come free and do not catch on the packing foam (Figure 2).
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Reference/
Ground Wires
Figure 1 Removing Screws
3.02
Wire
Bundle
Figure 2 Removing Array and Wire Bundle
Unpacking Procedure for Non-wire-bonded Array in Agarose
The unwire-bonded arrays are embedded in agarose during shipping to minimize damage to the array.
See Figure 3.
Figure 3: Arrays embedded in agarose
Cleaning Procedures:
(a) Remove the tape wrapped around the plastic Petri dish cover.
(b) Remove the lid and the plastic wrap.
(c) Using a scalpel cut the agarose around the array and remove the agarose piece with the array still
embedded in it (Figures 4 and 5).
Figure 4: Agarose cut out
Figure 5: Array in agarose
(d) Place the array in a glass Petri dish, filled with distilled water. Warm the distilled water to about 50°C60°C for 30-45 minutes or until all the agarose dissolves in the water (Figure 6).
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Array
Glass Petri Dish
Agarose Block
Distilled
Water
Hotplate
Figure 6: Dissolving agarose
(e) Remove the array with a pair of fine tip tweezers and place it in another glass petri dish filled with
fresh distilled water. Soak the array for about 30 minutes. Rinse it with fresh distilled water.
(f) Remove the array from the dish and let it air dry at room temperature in a Petri dish. You may wick
away excess rinse water with a soft KimWipe or filter paper by touching it gently to the side of the
electrode array (Figure 7). DO NOT TOUCH THE ELECTRODES!
Figure 7 Wick away excess water with KimWipe
(g) Under a microscope, check for foreign material on the array. If necessary, remove the debris with a
soft artist’s brush or use a syringe to gently squirt distilled water or isopropyl alcohol solution (ACS
grade, 99.5%) into the array.
(h) If necessary repeat step (f) to dry the array.
Please Note:
•
DO NOT handle the electrode array directly with fingers.
•
DO NOT ultrasonically clean the electrode array. This will damage the array.
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4. How To Interpret The Datasheet Sent With Your Array Assembly
The following are examples of Blackrock Research Assemblies types and Impedance tables.
Please contact our support team at [email protected] if you have custom connectors, custom
mappings or different headstages.
Note: Impedance readings were taken at room temperature and the impedance values are in kΩ. The temperature
of the conductive testing medium (such as saline) will change the impedance values measured. The recommended
testing solution is saline pH 7.0–7.2 warmed to 37°C. Only use equipment from Blackrock Microsystems for
measuring the impedances. Any devices that outputs current higher than 10nA may damage the electrodes.
4.01
CerePort™ Array Assembly
PEDESTAL TOP VIEW
ELECTRODE NUMBER LAYOUT ON LGA
LGA
Bonding pad view
of the Utah Array
GROUND
Pedestal
96
95
G2
88
87
78
86
77
68
67
58
57
48
47
38
37
28
27
18
17
wi re bundl e
8
Electrode number on view from pad side
9
19
29
39
49
59
69
79
1
10
20
30
40
50
60
70
80
89
2
11
21
31
41
51
61
71
81
90
3
12
22
32
42
52
62
72
82
91
4
13
23
33
43
53
63
73
83
92
5
14
24
34
44
54
64
74
84
93
6
15
25
35
45
55
65
75
85
94
94
85
76
66
56
46
36
26
16
7
93
84
75
65
55
45
35
25
15
6
7
16
26
36
46
56
66
76
86
95
92
83
74
64
54
44
34
24
14
5
8
17
27
37
47
57
67
77
87
96
18
28
38
48
58
68
78
88
91
82
73
63
53
43
33
23
13
4
90
81
72
62
52
42
32
22
12
3
wire bundle
119 194 165 184 239 215 392 419
88 167 436 390 391 330 326 427 397 269
89
ELECTRODE
PADS
80
71
61
51
41
31
21
11
2
79
70
60
50
40
30
20
10
1
69
59
49
39
29
19
9
R2
R1
120 242 298 324 334 283 280 309 329 350
143 193 158 213 425 219 274 366 278 210
G1
wire bundle 155 175 183 169 239 211 290 442 317 275
REFERENCE
150 205 238 241 442 266 309 470 286 173
117 170 191 169 346 212 365 452 306 171
GROUND
124 622 628 245 429 339 226 302 216 161
114 175 136 1111 355 352 190 193 174 136
99 101 138 286 247 168 149 155
Electrode Impedance viewing from pad side
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CerePort ™ Array Assembly (Cont.)
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4.02
ICS-96 Array Assembly
IDC pin numbers ICS-96 Array assembly TOP VIEW
Reference wire
Array pad
side view
corresponding electrode
numbers
Wire Bundle
02
02
01
01
04
04
03
03
06
06
05
05
08
08
07
07
10
10
09
09
12
12
11
11
14
14
13
13
16
16
15
15
18
18
17
17
20
20
19
19
22
22
21
21
24
24
23
23
26
26
25
25
28
28
27
27
30
30
29
29
32
32
31
31
34
G
R2
33
36
bs
G
35
C
02
34
33
01
04
36
35
03
06
38
37
05
08
40
39
07
10
42
41
09
12
44
43
11
14
46
45
13
16
48
47
15
18
50
49
17
20
52
51
19
22
54
53
21
24
56
55
23
26
58
57
25
28
60
59
27
30
62
61
29
32
64
63
31
34 36
G bs
G G
33 35
B
02 04 06 08 10 12 14 16 18 20 22 24 26 28 30 32 34 36
66 68 70 72 74 76 78 80 82 84 86 88 90 92 94 96 G bs
R1 G
01 03 05 07 09 11 13 15 17 19 21 23 25 27 29 31 33 35
A
65 67 69 71 73 75 77 79 81 83 85 87 89 91 93 95
Ground
wire
Reference wire
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4.03
Omnetics Array Assembly
Omnetics array assembly comes in 6 different configurations: 1x16, 2x16, 3x16, 1x32, 2x32, and 3x32.
Below are couple examples of these assemblies.
4.03.1
Omnetics Array Assembly 1x16
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4.03.2
Omnetics Array Assembly 1x32
Omnetics Array Assembly 1x32 TOP VIEW
Reference
Ground 1
Ground
Wire bundle
Array pad
view
Reference 2
40
20
39
19
38
18
37
17
36
35
34
33
32
31
30
29
28
27
26
25
24
23
22
21
16
15
14
13
12
11
10
9
8
7
6
5
4
3
2
1
Ground 2
Ground
Reference
Connector pin number
4.03.3
Reference 1
wire to electrode
Reference and ground wires on Omnetics Array Assembly Board (Viewing From Pad Side)
Figures below show reference and ground wires layout on Omnetics assembly boards (figures 8 and 9).
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Figure 8: Reference and ground wires layout on 16 channels Omnetics connector board
Figure 9: Reference and ground wires layout on 32 channels Omnetics connector board
4.03.4
Omnetics Board Orientation
When connecting the Omnetics connector assembly, please check for the orientation of the assembly
connector (figure 10).
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Figure 10: Omnetics Array Assembly
5. Sterilization
5.01
Blackrock recommends ETO sterilization according to the protocol below (Table 1). Do not use other
methods of sterilization, as these may damage the integrity of the array. Contact Blackrock Support
([email protected]) with additional questions.
Table 1: ETO Processing Parameters
Preconditioning
Temperature:
Relative Humidity:
Time:
Set Point
110°F
65%
24Hrs 0Min
125°F
Minimum
105°F
45%
24Hrs 0Min
115°F
Maximum
120°F
75%
72Hrs 0Min
135°F
Evacuate To:
Humidity Pressure Rise:
N2 Inject To:
Evacuate To:
5.8 inHgA
inHgA
25.3 inHgA
5.8 inHgA
5.3 inHgA
inHgA
24.8 inHgA
5.3 inHgA
6.3 inHgA
inHgA
25.8inHgA
6.3 inHgA
Pressure Rise:
Dwell Time:
Maintain Pressure At:
1.4 inHgA
30 Min
7.2 inHgA
0.9 inHgA
29 Min
6.7 inHgA
1.9 inHgA
35 Min
7.7 inHgA
Gas Pressure-Inject To:
Temperature:
Time:
At:
Evacuate To:
Vacuum Hold Time:
Inject To:
Evacuate To:
Vacuum Hold Time:
Number of Cycles
Inject To:
17.9 inHgA
125°F
4hrs 0min
17.9 inHgA
7.8 inHgA
1Hrs 00Min
24.8 inHgA
5.8 inHgA
30Min
0 (1 total)
24.8 inHgA
17.4 inHgA
120°F
3hrs 59min
17.4 inHgA
7.3 inHgA
0Hrs 59Min
24.3 inHgA
5.3 inHgA
29 Min
18.4 inHgA
130°F
4hrs 40min
18.4 inHgA
9.3 inHgA
1Hrs 4Min
25.3inHgA
7.3 inHgA
34 Min
24.3 inHgA
25.3inHgA
Process Temperature
Vacuum A
Approx. Rate: 0.7”/min
Nitrogen Dilution
Humidification
Humidity Dwell
Gas A
Gas Dwell
Maintain Pressure: Yes
Sterilant / Inert: Sterilant
After Vacuum
Gas Wash A
Inject Type: Inert
Gas Wash B
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Inject Type: Inert
Evacuate To:
Number of Cycles
5.8 inHgA
2 (3 total)
5.3 inHgA
6.3 inHgA
Release To:
Temperature:
Time:
24.8 inHgA
110°F
36 Hrs
inHgA
100°F
36 Hrs
inHgA
135°F
N/A
Release
Approx. Rate: 0.7" / Min
Heated Aeration
6. Cleaning and Storage for Arrays Used in Acute Preparations
6.01
Remove the array from the subject and immediately place it in clean distilled water until it will be cleaned.
6.02
Secure the connector on a lab stand. Immerse the electrode array and wire bundle in warm (30-35ºC)
distilled water or enzymatic cleaner for 15 to 60 minutes. Figure 12 shows one way to suspend the
electrode array in a beaker of cleaning solution with a heating and stirring plate for SLOW stirring.
Connector
Distilled
Water
Stirrer
Hotplate
Figure 12: Cleaning array assembly in distilled water
6.03
Under a microscope, check for debris stuck in the array. If necessary, remove the debris with a small soft
artist’s brush or use a syringe to gently squirt cleaning solution into the array.
6.04
Rinse with distilled water. When using detergent cleaning solution (such as Enzyme/distilled water
mixture), soak the array in warm (30-35ºC) distilled water for an additional 30 minutes and rinse again.
6.05
Let the array air dry at room temperature. You may wick away excess rinse water with soft KimWipe or
filter paper by touched gently to the side of the electrode array (Figure 13).
Figure 13: Wick away excess water with KimWipe
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6.06
If possible test the assembly impedance in solution (such as saline pH 7.0–7.2) at 37°C. Impedance values
are typically in the range of:
a.
100 KΩ – 800 KΩ for Pt tip array
b.
1 KΩ – 80 KΩ for SIROF tip array
7. Warranty
Blackrock Microsystems, Inc. warrants that its products are free from defects in materials and manufacturing for
a period of one year from the date of shipment. Blackrock will, at its option, repair or replace any product that
does not comply with this warranty. This warranty is voided by:
1.
Any modification or attempted modification to the product done by anyone other than an authorized
Blackrock’s employee.
2.
Any abuse, negligent handling or misapplication of the product.
This constitutes the sole warranty made by Blackrock, Inc. There are no other warranties, expressed or implied,
which extend beyond those described herein or to anyone other than the original purchaser, including the
implied warranties of merchantability and fitness for a particular purpose. In no event shall Blackrock
Microsystems, Inc. be liable for any incidental or consequential damages, or for the infringement of any patent
rights or third party rights due to the use of its products.
8. Return Merchandise Authorization (RMA)
In the unlikely event that your Array Assembly needs to be returned to Blackrock Microsystems for repair,
inspection or replacement. Please do not return any assembly back without a Return Merchandise Authorization
Number. An RMA number can be obtained by contacting a Blackrock Microsystems support representative at
(801) 839-1062 or toll free at (866) 806-3692. You can e-mail Blackrock’s Support at [email protected]
to request an RMA number.
Once an RMA number has been issued, it is important to safely pack the returned item for shipping to Blackrock. It
is preferred that you save the original boxes and packing materials that your system arrived in for return shipment.
Please address the package as follows:
Blackrock Microsystems, Inc.
ATTN: RMA#
630 Komas Drive, Suite 200
Salt Lake City, UT 84108 USA
Tel: (801) 582-5533
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Blackrock Research Assemblies

Transcription

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