IntraSense TM Series 1-French Wire-Connected Pressure Sensor Standard IntraSense TM Families FEATURES Miniature size: 750 µm 220 µm 75 µm Fits within 1-French catheter products Typical stability <1 mmhg/hour drift in 37 C saline Encapsulated trifilar connection for ease of integration Meets AAMI specification guidelines RoHS and REACH Compliant Biocompatible materials Option for light shielding DESCRIPTION The IntraSense TM series pressure sensors are designed to fit into a 1-French hypo tube or to be mounted to a housing. The pre-attached, encapsulated wire simplifies the connection for the end user. Additional gel or encapsulation is not required after the sensor is mounted. This absolute die delivers accurate and stable pressure for acute procedures in the clinically useful range of -300 mmhg to +300mmHg. Wider pressure ranges are available for specialized applications. This device delivers high stability in both air and 37 C saline. The proximal end of the trifilar is terminated in 2cm stripped bare copper wires. Customized length of wire and die shapes are available for specialized applications. This device is intended for single use. Medical Applications ENDOVASCULAR UROLOGY NEUROLOGY OTHER Invasive blood pressure Endourology Intracranial pressure monitors Labor and childbirth Central arterial line Urinalysis Spinal pressure Guided biopsies Swan-Ganz catheters Animal monitoring Trauma response Page 1
Absolute Maximum Ratings All parameters are specified at VSUPPLY = 2.5 V supply voltage at 37 o C in air, unless otherwise noted. No. Characteristic Symbol Minimum Typical Maximum Units 1 Excitation Voltage (a,b) air V DD -0.2-3.0 V 2 Excitation Voltage (a,b) liquid V DD -0.2-1.0 V 3 Operating Temperature T OP 0 - +105 C 4 Manufacturing / Assembly Temperature (c) T AS 0 - +180 C 5 Storage Temperature T STG 0 - +105 C 6 ESD Rating ESD TBD kv HBM 7 Proof Pressure P PROOF 1300 mmhg 8 Burst Pressure P BURST 4000 mmhg Notes: a. Half bridge shall be driven with supply voltage applied to the Vdd pad. b. For best performance in liquid, a maximum supply voltage of 1.0V or 300 µamps is recommended. At higher voltages in 37 C saline, reduction in device lifetime has been observed. c. The device, Insulations of wire, and epoxy are rated up to 180 C Operating Characteristics - Specifications All parameters are specified at 37 o C, unless otherwise noted. No. Characteristic Symbol Minimum Typical Maximum Units 9 Full Scale Span (d,e) V SPAN 4 mv/v 10 Pressure Sensitivity, SMI-1A (d,e) S V 6 µv/v/mmhg 11 Pressure Sensitivity, SMI-1B (d,e) S V 5 µv/v/mmhg 12 Zero Pressure Offset (d) V OFFSET 7 mv/v 13 Offset at Ambient Pressure (d,f) V CLINICAL 12 mv/v 14 Input Resistance (d) R BRIDGE 2615 3350 3615 Ω 15 Clinical Pressure Nonlinearity (d,f) NL -0.04 %FS 16 Output Stability (g) STB < + 1 mmhg shift in zero offset per hour 17 Temperature Coefficient of Zero Offset (d,h) TCZ (c) -0.1 %FS/ C 18 Temperature Coefficient of Span (d,h) TCS (c) -0.22 %FS/ C 19 Temperature Coefficient of Resistance (d,h) TCR (c) 0.12 %Rb/ C 20 Pressure Hysteresis (d,e) P HYST < 0.5 %FS 21 Temperature Hysteresis (c, g) T HYST < 0.2 %FS Notes: d. Measurements made by connecting the half-bridge sensor to two additional 0ppm TCR 2731 Ohm resistors to form a complete Wheatstone bridge. See Full Bridge diagram on p. 4. e. Calculated from 460mmHg absolute to 1060mmHg absolute (-300mmHg to +300mmHg gauge). f. Determined at 760mmHg absolute g. Determined during immersion in 37 C saline, 1.0V supply. h. Determined in the temperature range 0 C to 50 C Page 2
IntraSense TM Diagrams and Dimensions Unique die ID 220 + 0.01 750 + 0.025 775 + 10 Encapsulation Sensor Thickness = 75 + 12 Encapsulation thickness TBD All dimensions are in microns. SMI-1A Standard SMI-1B Light-Shielded Wire Bond Pad Description Wire Color Wire Name Pad Function Green V DD V SUPPLY Yellow R Center Sig+ Red R Edge Sig- Page 3
Standard IntraSense TM Half-Bridge Constant Current Mode: Current level should be chosen for patient safety, signal-to-noise and lifetime requirements. Recommended currents < 300 ua for maximum lifetime in liquid. (Blue portions of circuit supplied by customer.) Refer to AAMI-ES1 for patient safety limits. Constant Voltage Mode: Voltage level should be chosen for patient safety, signal-to-noise and lifetime requirements. Recommended voltage between Vdd and Sig+/Sig- are < 1.0V for maximum lifetime in liquid (Blue portions of circuit supplied by customer). Refer to AAMI- ES1 for patient safety limits. Full-Bridge IntraSense TM Connected to SMI Test Board In this configuration, a constant voltage is maintained between Vdd and Gnd and the voltage drop from Sig+ to Sig- is proportional to pressure. Bridge can be driven in constant current or constant voltage mode; for maximum lifetime, maintain currents < 300uA or voltage < 1.0V. Pin Connection Purpose 1 (Marked with 1 ) Sig- Signal Low 2 Power Ground 3 Power Supply Voltage 4 Sig+ Signal High Pin order will be reversed if connections are made to the opposite side of the board Page 4
Guide to Die Attach Pressuresensitive membrane Top Bare sensor (for reference) Top Wire-attached device Bottom Back of the sensor Apply die attach / adhesive on the backside of the die in this region to avoid unwanted stress on membrane. Silastic Medical Adhesive Type A from Dow Corning or Dymax 1128 A- M Gel are both low-stress, biocompatible die-attach materials. Page 5
Ordering Information Order Code Standard SMI-1A-48-XXX-AAUU SMI-1A-48-XXX-ABUU SMI-1B-48-XXX-AAUU SMI-1B-48-XXX-ABUU Design Feature XXX is the wire length in cm. Available wire length range from 050 cm to 300 cm 1A = standard, 1B = light shielded For calibrated, temperature compensated devices, please refer to the IntraSense TM Calibrated datasheet at For custom features, contact SMI Sales at (408) 577-0100 or sales@si-micro.com Part Number Legend SMI - 1A - 48-180 - AAUU Silicon Microstructures IntraSense TM Sensor Family Revision A Standard Revision B Light-Shielded A.W.G. Wire Gauge Trifilar Length (cm) Epoxy Type Proximal End Configuration A = Bare IntraSense TM B = Sample Board Calibration Code (UU = uncalibrated) Shipping method is as yet unspecified. CAUTION: This pressure transducer is not protected against defibrillation discharges. It must be used only with monitors labeled as having an isolated defibrillator-protected patient connection. IntraSense TM has not been qualified as an implantable device. It is designed for single use. Page 6
Warranty and Disclaimer Silicon Microstructures Warranty and Disclaimer: Silicon Microstructures, Inc. reserves the right to make changes without further notice to any products herein and to amend the contents of this data sheet at any time and at its sole discretion. Information in this document is provided solely to enable software and system implementers to use Silicon Microstructures, Inc. products and/or services. No express or implied copyright licenses are granted hereunder to design or fabricate any siliconbased microstructures based on the information in this document. Silicon Microstructures, Inc. makes no warranty, representation, or guarantee regarding the suitability of its products for any particular purpose, nor does Silicon Microstructures, Inc. assume any liability arising out of the application or use of any product or silicon-based microstructure, and specifically disclaims any and all liability, including without limitation consequential or incidental damages. Typical parameters which may be provided in Silicon Microstructure s data sheets and/or specifications can and do vary in different applications and actual performance may vary over time. All operating parameters, including Typicals, must be validated for each customer application by customer s technical experts. Silicon Microstructures, Inc. does not convey any license under its patent rights nor the rights of others. Silicon Microstructures, Inc. makes no representation that the circuits are free of patent infringement. Silicon Microstructures, Inc. products are not designed, intended, or authorized for use as components in systems intended for surgical implant into the body, or other applications intended to support or sustain life, or for any other application in which the failure of the Silicon Microstructures, Inc. product could create a situation where personal injury or death may occur. Should Buyer purchase or use Silicon Microstructures, Inc. products for any such unintended or unauthorized application, Buyer shall indemnify and hold Silicon Microstructures, Inc. and its officers, employees, subsidiaries, affiliates, and distributors harmless against all claims, costs, damages, and expenses, and reasonable attorney fees arising out of, directly or indirectly, any claim of personal injury or death associated with such unintended or unauthorized use, even if such claim alleges that Silicon Microstructures, Inc. was negligent regarding the design or manufacture of the part. Silicon Microstructures, Inc. warrants goods of its manufacture as being free of defective materials and faulty workmanship. Silicon Microstructures, Inc. standard product warranty applies unless agreed to otherwise by Silicon Microstructures, Inc. in writing; please refer to your order acknowledgement or contact Silicon Microstructures, Inc. directly for specific warranty details. If warranted goods are returned to Silicon Microstructures, Inc. during the period of coverage, Silicon Microstructures, Inc. will repair or replace, at its option, without charge those items it finds defective. The foregoing is buyer s sole remedy and is in lieu of all warranties, expressed or implied, including those of merchantability and fitness for a particular purpose. In no event shall Silicon Microstructures, Inc. be liable for consequential, special, or indirect damages. While Silicon Microstructures, Inc. provides application assistance personally, through its literature and the Silicon Microstructures, Inc. website, it is up to the customer to determine the suitability of the product for its specific application. The information supplied by Silicon Microstructures, Inc. is believed to be accurate and reliable as of this printing. However, Silicon Microstructures, Inc. assumes no responsibility for its use. Silicon Microstructures, Inc. assumes no responsibility for any inaccuracies and/or errors in this publication and reserves the right to make changes without further notice to any products or specifications herein Silicon Microstructures, Inc.TM and the Silicon Microstructures, Inc. logo are trademarks of Silicon Microstructures, Inc. All other service or product names are the property of their respective owners. Silicon Microstructures, Inc. 2001-2018. All rights reserved. Page 7