SCI-ADS1298FE-MVK MAVRK Module
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MAVRK is no longer an active TI evaluation platform. Please contact TI application support if you need further information on TI products or support.
Board Status: Level Test
Purpose of this Wiki Page
This page explains the Signal Conditioning Interface (SCI) ADS1298 Modular and Versatile Reference Kit (MAVRK) module in detail. For more information on the MAVRK system, referring to the MAVRK Introduction page is good start. After reading this guide, a developer should understand the features of the SCI-ADS1298 MAVRK module.
EVM Overview
The SCI-ADS1298-MVK module allows a patient Electrocardiography| Electrocardiography (ECG) simulator to be interfaced to the Modular and Versatile Reference Kit (MAVRK) system. A complementary Analog Front End (AFE) module would be the AFE-ADS1298-MVK MAVRK Module, which highlights the ADS1298 24 bit, multi-channel data converter well suited for ECG applications.
EVM Description
The SCI-ADS1298FE-MVK is a Signal Conditioning (SCI) module providing an analog interface to its complementary AFE module (located in the AFE slot above it). This module gives external connections of the 16 single ended or 8 differential analog lines from the AFE module. Power for this AFE module is also provided by the SCI-ADS1298FE-MVK module. This allows the same AFE module to be used in a split rail or single rail system. The SCI-ADS1298FE-MVK also has pads providing for the addition of surge protection devices. The [AFE-ADS1298-MVK] is a typical complementary device to the SCI-ADS1298-MVK module.
Figure 1: SCI-ADS1298FE-MVK module
Features
- Provides +/- 2.5V DC to the power the complementary AFE Module slot (above it).
- Provides +/- 2.75V DC to the power the reference circuit on the complementary AFE Module slot.
- A keyed 16 pin dual row header allows interface an ECG Patient Simulator, like the Fluke, to the 16 analog channels on the complementary AFE slot.
- Pads available to add surge protectors.
Featured Applications
The SCI-ADS1298FE-MVK MAVRK Module can be used to demonstrate the following applications:
- [Electrocardiography (ECG) Medical Instrumentation]
- [Electromyography (EMG) Medical Instrumentation]
- [Electroencephalography (EEG) Medical Instrumentation]
- Patient monitoring; Holter, event, stress, and vital signs including ECG, AED, and telemedicine
- High-Precision, Simultaneous, Multi-channel Signal Acquisition Applications
Highlighted Products
The SCI-ADS1298FE-MVK MAVRK Module features the following devices:
- TPS62120 - 15V, 75mA, 96% efficiency Step-Down Converter
- TPS63700 - Adjustable, -15V Output Inverting DC/DC Converter in 3x3 QFN
- TPS7A3001 - Vin -3V to -36V, -200mA, Ultra-Low Noise, High PSRR, Low-Dropout Linear Regulator
- TPS7A4901 - Vin 3V to 36V, 150mA, Ultra-Low Noise, High PSRR, Low-Dropout Linear Regulator
Block Diagram
Figure 2. SCI-ADS1x9xFE-MVK Block Diagram
EVM Wiki
SCI-ADS1298FE-MVK Module wiki page
EVM Landing Page
SCI-ADS1298FE-MVK MAVRK Module tool folder
Hardware Description
Power Requirements
The SCI-ADS1298FE-MVK utilizes the AVDD_5.5V power rail to generate +/- 2.75V to power the AFE Reference Circuit and +/-2.5V to power the Data Converter in the AFE slot. Will not constrained by the hardware, it is expected that none of these rail pull more than 20ma.
Power Ripple Performance
The figure below is a snap shot of the Power Circuit for the SCI-ADS1298FE-MVK.
It is powered from the Motherboard's AVDD_5.5V power rail which is capable of delivering a total of 1.5A to 8 modules slots (AFE1-4 and SCI1-4).
Figure #. SCI-ADS1298FE-MVK Power Test Points
Test Point 1
Starting at the positive supply, Figure # shows the input from the motherboard to the TPS62120 which converts the 5.5V to 3.0V.
Figure #. SCI-ADS1298-MVK Input Voltage at the Positive Supply
Test Point 2
Figure # shows the output of the TPS62120.
Figure #. SCI-ADS1298FE-MVK Output Voltage at the Positive Switcher Supply
Test Point 3
Figure # shows the output voltage to the AFE Reference Circuit's positive supply of 2.75V.
Figure #. SCI-ADS1298FE-MVK AFE Reference Supply Voltage
Test Point 4
Figure # shows the output voltage to the AFE's positive supply of 2.5V.
Figure #. SCI-ADS1298FE-MVK AFE Supply Voltage
Test Point 5
For the negative supply, Figure # shows the input from the motherboard to the TPS63700 which converts the 5.5V to -3.0V.
Figure #. SCI-ADS1298-MVK Input Voltage at the Negative Supply
Test Point 6
Figure # shows the output of the TPS63700
Figure #. SCI-ADS1298-MVK
SCI-ADS1298FE-MVK Performance Test Data
MAVRK adds versatility to an Analog Signal chain by allowing different sensor or signal conditioning front ends to be utilized with an AFE module. To allow this versatility, a series of connectors is incorporated as shown in the figure below. The MAVRK team tests the performance of the AFE Module as well as the performance through the AFE to Motherboard and Motherboard to SCI connectors. This performance test does not incorporate the sensor or connections on the SCI Module but instead gives the user a view of the performance through the MAVRK Motherboard and the AFE to SCI Connectors.
Figure XX: AFE to SCI Analog Signal Path
Below is the test setup of the SCI-ADS1298FE-MVK MAVRK Module. The test incorporates shorting the analog inputs at the SCIX_CON_4 to ground of the SCI-ADS1298FE-MVK.
Download a PDF of the SCI-ADS1298FE-MVK Test Setup.
Getting Started: Configuring the EVM
The SCI-ADS1298FE-MVK module is supported by the MAVRK AppMonitor and AppSelect tools. For more information on these tools and how to install them, please refer to the How to get the MAVRK Software link below.
The preferred method of working with this EVM is through the use of the MAVRK PRO motherboard, the motherboard will provide the needed power and digital control for this EVM. The software demo utilizes MAVRK_AFE3 as the image in Figure 4 shows, however (with a small change in software) it is also possible to insert the SCI-ADS1298-MVK into any of the other 3 SCIslots are retain full functionally. Also in the picture is the AFE-ADS1298-MVK in MAVRK_AFE3 which provides Analog Channel Conversion for the signals coming from the SCI-ADS1298FE-MVK.
The power source in this demo shown in Figure 4 is the USB cable. It should be noted that when any board on the MAVRK board is installed or removed, all power sources should be moved first by pressing the Standby button.
Typical installation of the module is as follows:
1. Plug in the USB.
a. The Standby button should be blue, which effectively removes all power from the modules on the mother board.
2. Run the MAVRK App Select tool
3. Install all modules required for the demo
a. An MCU module to initialize the motherboard and the AFE-ADS1298-MVK
b. At least one AFE-ADS1298-MVK. It should be noted multiple AFE's can be installed.
c. At least one SCI module in the slot below the AFE module. The SCI-ADS1298-MVK is an example
d. The AFE-BREAKOUT-MVK module is not required, but can be installed to watch signals GPIO and SPI signals of the adjacent module.
3. Install the JTAG debugger if a C Compiler is used to download code into the MCU. Otherwise the QT tool will utilize the USB connection to download the code.
4. Press the Standby button to provide power to the modules.
Figure 4: ADS1298 Demo Setup in Standby Mode
EVM Connectors, Fuses, and Switches
The figure below shows the Analog Input Header for the SCI-ADS1298-MVK Module.
| Pin #
| Input Description
| SCI_X_ANLG_Channel Number
|
| 1 | Input Channel 2 | SCI Analog Channel 6 |
| 2 | Input Right Arm | SCI Analog Channel 3 |
| 3 | Input Channel 3 | SCI Analog Channel 8 |
| 4 | Input Left Arm | SCI Analog Channel 2 |
| 5 | Input Channel 4 | SCI Analog Channel 10 |
| 6 | Input Left Leg | SCI Analog Channel 4 |
| 7 | Input Channel 5 | SCI Analog Channel 12 |
| 8 | Input Channel 1 | SCI Analog Channel 14 |
| 9 | Input Channel 6 | SCI Analog Channel 0 |
| 10 | No Connect | No Connect |
| 11 | External Shield | SCI GPIO 1 |
| 12 | Input Right Leg | SCI GPIO 2 |
| 13 | No Connect | No Connect |
| 14 | No Connect | No Connect |
| 15 | No Connect | No Connect |
| 16 | Ground | Ground |
Figure XX: SCI-ADS1298-MVK Analog Input Header
The figure below shows the jumper that connects the External Shield Drive Amplifier to the Analog Input Header Pin 11.
Figure XX: SCI-ADS1298-MVK External Shield Drive Select
EVM Test Points
The SCI-ADS1298FE-MVK MAVRK module has two ground test points as shown in the figure below.
Figure XX: SCI-ADS1298FE-MVK Test Points
EVM LEDs
The SCI-ADS1298FE-MVK MAVRK Module has no LEDs populated.
Software Installation
MAVRK Software Minimum Requirements
- IAR Embedded Workbench software or TI Code Composer Studio software installed on PC
- USB Cable(A to Mini B) to power the MAVRK Pro motherboard
- Windows XP SP3 or Windows 7
How to get the MAVRK Software
This module is supported with the MAVRK AppSelect tool and the MAVRK AppMonitor tool
To download and install the MAVRK AppSelect and AppMonitor tools, refer to the Software Installation Guide.
Where do I find the MAVRK Qt Demo Application?
An application to visual packet information from the embedded system can be found in the mavrk_qt_tool software repository under the Released Version - QT Demo Application directory. Please see Software Installation Guide for instructions on cloning the QT Tool project.
If you desire to create your own Qt demonstration, please reference the following resources:
Where do I find the Demo and Test Code?
- MAVRK template files for this part are located here: mavrk_embedded\Modular_EVM_Libraries\Components
- MAVRK projects for this part are located here: \mavrk_embedded\Modular_EVM_Projects\
- Specific related projects for this part are: \mavrk_embedded\Modular_EVM_Projects\Component_Demo_Projects\ADS1298-MSP430F5438_Demo_Project
MAVRK ADS1298 Demo Application?
Demonstrating the ADS1298 MAVRK Module
Board Files
Bill of Materials (BOM)
Download a PDF of the bill of materials.
Layout (PDF)
[<pdf_link> Download a PDF] of additional board layers.
[[Image:<image_file>|border|300px|link=<image_link>]]
Schematics (PDF)
Download a PDF of all schematics.
Fabrication Drawings (PDF)
Download a PDF of the fabrication drawing.
Gerber Files
Download a ZIP of the Gerber files.
Cadence Schematic and Board Files
Download a ZIP of the Cadence schematic and board files.
MAVRK Links
I want more info on MAVRK
Visit the MAVRK wiki pages to get comprehensive information on MAVRK.
I have MAVRK Questions
Post your questions on the MAVRK Forum and get an answer from the MAVRK team.
(Recommended):
I want more Technical Info on MAVRK Hardware
Read through some of the hardware wiki pages below.
I want more Technical Info on MAVRK Software
Read through some of the software wiki pages below.
I want to get a MAVRK board
You can order a MAVRK Starter kit from the MAVRK Starter Kit tool folder page. To order other modules, search for them by name on TI's Web site to find their tool folder pages.
Important Notices
(NOTE: EDIT THIS SECTION AFTER THE BOARD MEETS FCC/IECS COMPLIANCE. FIX THE FCC AND ICES PDF LINKS AND CHANGE {{MAVRK Imporatant Notices}} to {{MAVRK Important Notices Complies FCC}}. Please hide this paragraph with < nowiki ></ nowiki > tags when you produce a guide from this template.)
ESD Precautions
The following guidelines should be followed in order to avoid ESD damage to the board components:
- Any person handling boards must be grounded either with a wrist strap or ESD protective footwear, used in conjunction with a conductive or static-dissipative floor or floor mat.
- The work surface where boards are placed for handing, processing, testing, etc., must be made of static-dissipative material and be grounded to ESD ground.
- All insulator materials either must be removed from the work area or they must be neutralized with an ionizer. Static-generating clothes should be covered with an ESD-protective smock.
- When boards are being stored, transferred between operations or workstations, or shipped, they must be maintained in a Faraday-shield container whose inside surface (touching the boards) is static dissipative.
Certifications
(Insert links to the PDFs of the FCC and ICES standard reports above the other certifications. The will look like the first two links below.)
FCC standard EMC test report for the <Insert Module Name> aboard the MAVRK Pro Motherboard
ICES standard EMC test report for the <Insert Module Name> aboard the MAVRK Pro Motherboard
Statement on Registration, Evaluation, Authorization of Chemicals (REACh)
Evaluation Board/Kit/Module (EVM) Additional Terms
Texas Instruments (TI) provides the enclosed Evaluation Board/Kit/Module (EVM) under the following conditions:
The user assumes all responsibility and liability for proper and safe handling of the goods. Further, the user indemnifies TI from all claims arising from the handling or use of the goods.
Should this evaluation board/kit not meet the specifications indicated in the User’s Guide, the board/ kit may be returned within 30 days from the date of delivery for a full refund. THE FOREGOING LIMITED WARRANTY IS THE EXCLUSIVE WARRANTY MADE BY SELLER TO BUYER AND IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED, IMPLIED, OR STATUTORY, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE. EXCEPT TO THE EXTENT OF THE INDEMNITY SET FORTH ABOVE, NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR ANY INDIRECT, SPECIAL, INCIDENTAL, OR CONSEQUENTIAL DAMAGES.
Please read the User's Guide and, specifically, the Warnings and Restrictions notice in the User's Guide prior to handling the product. This notice contains important safety information about temperatures and voltages. For additional information on TI's environmental and/or safety programs, please visit www.ti.com/esh or contact TI.
No license is granted under any patent right or other intellectual property right of TI covering or relating to any machine, process, or combination in which such TI products or services might be or are used. TI currently deals with a variety of customers for products, and therefore our arrangement with the user is not exclusive. TI assumes no liability for applications assistance, customer product design, software performance, or infringement of patents or services described herein.
Regulatory Compliance Information
As noted in the EVM User’s Guide and/or EVM itself, this EVM and/or accompanying hardware may or may not be subject to the Federal Communications Commission (FCC) and Industry Canada (IC) rules.
For EVMs not subject to the above rules, this evaluation board/kit/module is intended for use for ENGINEERING DEVELOPMENT, DEMONSTRATION OR EVALUATION PURPOSES ONLY and is not considered by TI to be a finished end product fit for general consumer use. It generates, uses, and can radiate radio frequency energy and has not been tested for compliance with the limits of computing devices pursuant to part 15 of FCC or ICES-003 rules, which are designed to provide reasonable protection against radio frequency interference. Operation of the equipment may cause interference with radio communications, in which case the user at his own expense will be required to take whatever measures may be required to correct this interference.
General Statement for EVMs including a radio
User Power/Frequency Use Obligations: This radio is intended for development/professional use only in legally allocated frequency and power limits. Any use of radio frequencies and/or power availability of this EVM and its development application(s) must comply with local laws governing radio spectrum allocation and power limits for this evaluation module. It is the user’s sole responsibility to only operate this radio in legally acceptable frequency space and within legally mandated power limitations. Any exceptions to this is strictly prohibited and unauthorized by Texas Instruments unless user has obtained appropriate experimental/development licenses from local regulatory authorities, which is responsibility of user including its acceptable authorization.
For EVMs annotated as FCC – FEDERAL COMMUNICATIONS COMMISSION Part 15 Compliant
Caution
This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment.
FCC Interference Statement for Class A EVM devices
This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his own expense.
FCC Interference Statement for Class B EVM devices
This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:
- Reorient or relocate the receiving antenna.
- Increase the separation between the equipment and receiver.
- Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
- Consult the dealer or an experienced radio/TV technician for help.
For EVMs annotated as IC – INDUSTRY CANADA Compliant
This Class A or B digital apparatus complies with Canadian ICES-003.
Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.
Concerning EVMs including radio transmitters
This device complies with Industry Canada licence-exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device.
Concerning EVMs including detachable antennas
Under Industry Canada regulations, this radio transmitter may only operate using an antenna of a type and maximum (or lesser) gain approved for the transmitter by Industry Canada. To reduce potential radio interference to other users, the antenna type and its gain should be so chosen that the equivalent isotropically radiated power (e.i.r.p.) is not more than that necessary for successful communication. This radio transmitter has been approved by Industry Canada to operate with the antenna types listed in the user guide with the maximum permissible gain and required antenna impedance for each antenna type indicated. Antenna types not included in this list, having a gain greater than the maximum gain indicated for that type, are strictly prohibited for use with this device.
~
Cet appareil numérique de la classe A ou B est conforme à la norme NMB-003 du Canada.
Les changements ou les modifications pas expressément approuvés par la partie responsable de la conformité ont pu vider l’autorité de l'utilisateur pour actionner l'équipement.
Concernant les EVMs avec appareils radio
Le présent appareil est conforme aux CNR d'Industrie Canada applicables aux appareils radio exempts de licence. L'exploitation est autorisée aux deux conditions suivantes : (1) l'appareil ne doit pas produire de brouillage, et (2) l'utilisateur de l'appareil doit accepter tout brouillage radioélectrique subi, même si le brouillage est susceptible d'en compromettre le fonctionnement.
Concernant les EVMs avec antennes détachables
Conformément à la réglementation d'Industrie Canada, le présent émetteur radio peut fonctionner avec une antenne d'un type et d'un gain maximal (ou inférieur) approuvé pour l'émetteur par Industrie Canada. Dans le but de réduire les risques de brouillage radioélectrique à l'intention des autres utilisateurs, il faut choisir le type d'antenne et son gain de sorte que la puissance isotrope rayonnée équivalente (p.i.r.e.) ne dépasse pas l'intensité nécessaire à l'établissement d'une communication satisfaisante.
Le présent émetteur radio a été approuvé par Industrie Canada pour fonctionner avec les types d'antenne énumérés dans le manuel d’usage et ayant un gain admissible maximal et l'impédance requise pour chaque type d'antenne. Les types d'antenne non inclus dans cette liste, ou dont le gain est supérieur au gain maximal indiqué, sont strictement interdits pour l'exploitation de l'émetteur.
Important Notice for Users of this Product in Japan
This development kit is NOT certified as Confirming to Technical Regulations of Radio Law of Japan! If you use this product in Japan, you are required by Radio Law of Japan to follow the instructions below with respect to this product:
- Use this product in a shielded room or any other test facility as defined in the notification #173 issued by Ministry of Internal Affairs and Communications on March 28, 2006, based on Sub-section 1.1 of Article 6 of the Ministry’s Rule for Enforcement of Radio Law of Japan,
- Use this product only after you obtained the license of Test Radio Station as provided in Radio Law of Japan with respect to this product, or
- Use of this product only after you obtained the Technical Regulations Conformity Certification as provided in Radio Law of Japan with respect to this product.
Also, please do not transfer this product, unless you give the same notice above to the transferee. Please note that if you could not follow the instructions above, you will be subject to penalties of Radio Law of Japan.
Texas Instruments Japan Limited (address) 24-1, Nishi-Shinjuku 6 chome, Shinjukku-ku, Tokyo, Japan
【ご使用にあたっての注意】
本開発キットは技術基準適合証明を受けておりません。
本製品のご使用に際しては、電波法遵守のため、以下のいずれかの措置を取っていただく必要がありますのでご注意ください。
(1)電波法施行規則第6条第1項第1号に基づく平成18年3月28日総務省告示第173号で定められた電波暗室等の試験設備でご使用いただく。
(2)実験局の免許を取得後ご使用いただく。
(3)技術基準適合証明を取得後ご使用いただく。
なお、本製品は、上記の「ご使用にあたっての注意」を譲渡先、移転先に通知しない限り、譲渡、移転できないものとします。
上記を遵守頂けない場合は、電波法の罰則が適用される可能性があることをご留意ください。
日本テキサス・インスツルメンツ株式会社
東京都新宿区西新宿6丁目24番1号
西新宿三井ビル
EVALUATION BOARD/KIT/MODULE (EVM) WARNINGS, RESTRICTIONS AND DISCLAIMERS
For Feasibility Evaluation Only, in Laboratory/Development Environments
Unless otherwise indicated, this EVM is not a finished electrical equipment and not intended for consumer use. It is intended solely for use for preliminary feasibility evaluation in laboratory/development environments by technically qualified electronics experts who are familiar with the dangers and application risks associated with handling electrical mechanical components, systems and subsystems. It should not be used as all or part of a finished end product.
Your Sole Responsibility and Risk
You acknowledge, represent and agree that:
- You have unique knowledge concerning Federal, State and local regulatory requirements (including but not limited to Food and Drug Administration regulations, if applicable) which relate to your products and which relate to your use (and/or that of your employees, affiliates, contractors or designees) of the EVM for evaluation, testing and other purposes.
- You have full and exclusive responsibility to assure the safety and compliance of your products with all such laws and other applicable regulatory requirements, and also to assure the safety of any activities to be conducted by you and/or your employees, affiliates, contractors or designees, using the EVM. Further, you are responsible to assure that any interfaces (electronic and/or mechanical) between the EVM and any human body are designed with suitable isolation and means to safely limit accessible leakage currents to minimize the risk of electrical shock hazard.
- You will employ reasonable safeguards to ensure that your use of the EVM will not result in any property damage, injury or death, even if the EVM should fail to perform as described or expected.
- You will take care of proper disposal and recycling of the EVM’s electronic components and packing materials.
Certain Instructions
It is important to operate this EVM within TI’s recommended specifications and environmental considerations per the user guidelines. Exceeding the specified EVM ratings (including but not limited to input and output voltage, current, power, and environmental ranges) may cause property damage, personal injury or death. If there are questions concerning these ratings please contact a TI field representative prior to connecting interface electronics including input power and intended loads. Any loads applied outside of the specified output range may result in unintended and/or inaccurate operation and/or possible permanent damage to the EVM and/or interface electronics. Please consult the EVM User's Guide prior to connecting any load to the EVM output. If there is uncertainty as to the load specification, please contact a TI field representative. During normal operation, some circuit components may have case temperatures greater than 60°C as long as the input and output are maintained at a normal ambient operating temperature. These components include but are not limited to linear regulators, switching transistors, pass transistors, and current sense resistors which can be identified using the EVM schematic located in the EVM User's Guide. When placing measurement probes near these devices during normal operation, please be aware that these devices may be very warm to the touch. As with all electronic evaluation tools, only qualified personnel knowledgeable in electronic measurement and diagnostics normally found in development environments should use these EVMs.
Agreement to Defend, Indemnify and Hold Harmless
You agree to defend, indemnify and hold TI, its licensors and their representatives harmless from and against any and all claims, damages, losses, expenses, costs and liabilities (collectively, "Claims") arising out of or in connection with any use of the EVM that is not in accordance with the terms of the agreement. This obligation shall apply whether Claims arise under law of tort or contract or any other legal theory, and even if the EVM fails to perform as described or expected.
Safety-Critical or Life-Critical Applications
If you intend to evaluate the components for possible use in safety critical applications (such as life support) where a failure of the TI product would reasonably be expected to cause severe personal injury or death, such as devices which are classified as FDA Class III or similar classification, then you must specifically notify TI of such intent and enter into a separate Assurance and Indemnity Agreement.
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