Patient Monitoring Reference Designs Overview
Patient Monitoring Reference Designs Overview
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Agenda
• TI in medical
• Market trend
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TI Semiconductors in every medical category
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Patient Monitoring Market Trend
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Patient Monitoring Basics
Arterial
volume
1 Heartbeat
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Patient Monitoring Basics
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ECG vs. PPG
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ECG Lead and ADC Channels Standards Electrodes Needed
IEC60601-2-51 – Diagnostics
1 Lead LA, RA
3 Lead LA, RA, LL
6 Leads LA, RA, LL
Number of ADC 12 Leads LA, RA, LL, V1-6
Number of Leads Leads Used
Channels
1 Lead I 1
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ECG characteristics
Frequency domain
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Challenges in measuring ECG
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Challenges in Optical Bio-Sensing
§ Ambient Light
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Medical Sector Page on TI web
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Medical Sensor Patches
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Multiparameter Patient Monitor
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Reference Design
Detailed Design
Considerations & Full
Applications Info Schematics
Comprehensive
Design Guides
Design Files
Bill
Of
Materials
TINA-TI
Boards Spice Simulation
Available for Comprehensive
Evaluation Test Results
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TIDA-01614
Multiparameter front-end for vital signs patient monitor reference design
Features Benefits
• System measures ECG, Heart Rate, SPO2, • Single IC does both ECG ,Respiration.
Respiration rate using ADS1292R and AFE4403 and • Pace Detection
Skin temperature using TMP117 • ECG with 3 electrodes
• Circuit enables three electrode operation including right • Three temperature sensors for temperature
leg drive with good CMRR measurement
• Pace detection circuit indicates presence of pacemaker
• Supports three 0.1 Celsius accurate sensors (TMP117)
to measure the skin temperature
• Enables data transfer over isolated UART interface
• Works with 3.7V Li ion rechargeable battery
• On board memory for data logging
Applications
• Multiparameter Patient Monitor
• Medical Sensor Patches
• Pulse Oximeter
• Electrocardiogram (ECG)
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Design Challenges TIDA-01614 Solves
Design Challenge 1: Design Challenge 2:
Integration of multiple modalities at optimum SNR Protection and isolation against ESD & defibrillation
levels and small form factor per IEC 60601-1-2
• Monitoring of ECG, Heart Rate, SPO2, • Using TVS0500 and series current limit
PTT, Respiration rate and Skin resistor. TVS0500 has lower clamping
temperature voltage to protect ADS1292R.
• Single Lead ECG with RLD (ADS1292R)
> Signal amplitude: 0.2mV~2mV (p-p);
> BW0.05 Hz to 2000 Hz
• Supports 3 LED and 3 Photodiodes with
ambient subtraction for SPO2 and Heart
Rate monitoring with AFE4403 • Isolated UART interface using an onboard
• Supports three 0.1 Celsius accurate MSP432P401, ISOW7842, TRS3232
sensors to measure the skin temperature
(TMP117)
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TIDA-01614: Multiparameter front-end reference design
ECG Analog Front End for vital signs patient monitor
Important Parameters:
• Input Bias Current
• Input Impedance
• Input Current Noise
• Input Voltage Noise
• Power Consumption
• DC/AC CMRR
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TIDA-01614 Test Setup and Test Results
Design Specs
Test Setup
GUI Display
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ADS1291/2
ADC specifications
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TIDA-010005/Software-Configurable Cardiac Pacemaker Detection Module Reference Design
Features Benefits
• Programmable Thresholds for detecting rise time, • Detection of various types of pacemaker pulse provides
amplitude, duration and polarity of pace pulse the user one stop solution
• Availability of measured parameters and conditioned • Modular approach compatible with other patient
pace signal on I2C Bus for further analysis and monitoring TI Designs such as TIDA-01614
processing • Compact form factor
• Interface with TI’s ADS129X series of ECG front end • A flag signal and onboard LED are the indication of
devices presence of ‘valid’ pace signal.
• Detection of negative pulse by handling polarity of pace
pulse by software command
Applications
• Multi-parameter Patient Monitor
• Medical Sensor Patches
• Electrocardiogram (ECG)
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Design Challenges TIDA-010005 Solves
Design Challenge: Low noise, highly integrated signal path for ECG with lead-off and pace detection:
to detect amplitude, rise time, width and polarity for diagnostics with different makes of Pacemaker
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Proposed Solution
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TIDA-010005 Technical Details
Negative Pace Signal Detection Negative Pace Pulse Detected by setting the
DACs Polarity Check (CH 6) Output High
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Test Pacemaker Detection with TIDA-010005 & TIDA-01614
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TIDA-01580 Wearable, Wireless, Multi-Parameter Patient Monitor
Reference Design
Features Benefits
• Simple Wearable Multi-Parameter Patient Monitor for Photo- • PPG supports 4 LEDs and 3 PDs with Digital Ambient subtraction to
plethysmography (PPG) and Electrocardiography (ECG) improve the SNR
• Provides Raw data to calculate heart-rate, Oxygen Concentration in Blood • AC and DC lead off detection helps in correct measurement of vital signs
(SpO2) and Pulse-transit Time (PTT) • Continuous Monitoring with lower operating power ensures battery life of
• Uses Single-chip Bio-sensing Front-End AFE4900 for Synchronized ECG & 30 days
PPG • Flexibility of ultra low power modes and integrated FIFO can keep MCU
• PPG (Optical heart-rate monitoring and SpO2) supports 4 LEDs and
into sleep to increase the battery operation time
3 PDs with Digital Ambient subtraction to improve the SNR
• ECG (LEAD I) signals
• Integrated ARM Cortex-M3 + 2.4GHz RF Transceiver (CC2640R2F)
supports wireless data transfer – BLE 4.2 and 5
• Operated from CR3032 (3V, 500mA Coin Cell Battery) with battery life of 30
days using highly efficient DC/DC converters
• Small form factor helps in easy adaptation to wearable applications
Target Applications
• Wireless Patient Monitor Pulse Oximeter
• Wearable Fitness & Activity Monitor ECG
• Device Datasheets:
‒ AFE4900 - CC2640R2F
‒ TPS61098 - TPS63036
‒ TPD1E10B06
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TIDA-01580 Medical Patches
This board is connected on
bottom of the main board
Side View
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Design Challenges TIDA-01580 Solves
Design Challenge #1:
Integration of multiple modalities at optimum SNR levels and small form factor
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Design Challenges TIDA-01580 Solves
Design Challenge # 3:
Extending battery life to multiple days to enable portability & wearability
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SHIP mode
• By definition: Ship mode electronically
disconnects the battery from the rest of the
system to minimize power drain while the
SHIP mode
product is idle. When the consumer turns the
product on for the first time, the battery connects
to the rest of the system and stays connected
until the system decides to put itself back into
ship mode.
Nurse’s Station /
Doctor’s Office
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Why TI SimpleLink™ for Multi-parameter patient monitor +
sensor patch?
Low Power Ease of use Secure Small size
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Invest once, reuse effortlessly
100% code reuse
Common software
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TIDA-010029
Wearable, 16-phase multi-sensor SpO2 and heart rate monitor (HRM) reference design with Bluetooth® 5
Features Benefits
• Provides raw data to calculate heart rate, SpO2, and other related • PPG supports 4 LEDs and 4 PDs with Automatic Ambient
parameters subtraction to improve the SNR
• Uses single-chip, bio-sensing, front-end AFE4420 device for PPG
• Continuous Monitoring with lower operating power ensures
measurement
battery life of 100 hours for continuous operation
• Enables signal acquisition of up to 16 phases and multi-
wavelength measurements with the flexible allocation of LEDs • Flexibility of ultra low power modes and integrated FIFO can
and photodiodes in each phase keep MCU into sleep to increase the battery operation time
• Integrated Arm® Cortex®-M3 and 2.4-GHz RF transceiver • Small form factor helps in easy adaptation to wearable
(CC2640R2F) supports wireless data transfer through Bluetooth® applications
low energy 4.2 and 5.0
Applications
• Pulse Oximeter
• Wearable Fitness and Activity Monitor
• Multiparameter Patient Monitor
• Medical Sensor Patches
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Design Challenges TIDA-010029 Solves
Design Challenge # 1:
Integration of multiple modalities at optimum SNR levels and small form factor
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Design Challenges TIDA-010029 Solves
Design Challenge # 2:
BLE connectivity that does not interfere with measurement accuracy
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TIDA-010029 board details
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TIDA-010043: Efficient, high-current, linear LED driver reference design for SpO2 and
other medical applications
Features Benefits
• Higher efficiency by providing headroom control to optimally
• Built-in self-calibration and look-up table for headroom
drive LED
• Diagnostics (LED open, LED short, LED disconnect) and
control
protection mechanism for fault by disconnecting the supply • Dynamic adjustment of the LED supply voltage, to achieve
using e-fuse optimal efficiency at the programmed current levels
• Wide operating input range from 1.8 V to 5.5 V to support all
battery type inputs
• Programmable range selection for LED current (from 100 mA
to 1.5 A)
• Compatible with AFE44xx series EVMs (tested with AFE4403
EVM) for driving LEDs
• Tested with MSP430G2553 LAUNCHPAD™ and two on-
board LEDs (green and red)
Target Applications
Pulse oximeter Multiparameter patient
monitor
Endoscope Surgical equipment
Tools & Resources
Device datasheets:
• TPS63802 TPS2595
• CSD13306W CSD13202Q2
• TMUX1119 TLV7021
• OPA333
OPA365
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Design Challenges TIDA-010043 solves
Design Challenge: Accurate SpO2 measurement across varying photodiode placements, wavelengths and body
physiologies through optimizing LED driving circuit and photo-diode signal chain at low power
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TIDA-010043 Technical Details – flowchart
These are number of steps for calibration
These are course and fine levels for setting
the PWM to set the LED supply voltage
(Each step in calibration has to go through
course and fine level adjustment)
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TIDA-010043 Technical Details – Calibration
No. of steps
15 for calibration
(before calibration) 11 12 13 14
10
4.7V 8 9
5 6 7
Software steps for 4
1 2 3
calibration (the
current through (after calibration)
LED will increase
by 100mA for
2.8V
each step)
Each calibration step has
course and fine levels for
setting the LED supply voltage
TPS63802 Vout
(LED Supply
Voltage)
FET_SAT signal
(used for sensing
if the LED current
is gone out of
linear region)
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TIDA-010043 Technical Details – block diagram
Calibration
loop
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TIDA-01624 Bluetooth-Enabled High Accuracy Skin Temperature
Measurement Flex PCB Patch
Features Benefits
• High Accuracy, Low Power Temperature Sensor • Low power consumption and long battery life
• BLE 4.2 and 5 enabled microcontroller • Extremely long shelf life (3+ Years)
• Thin-Film Flexible Battery Power, enabling entirely • Small, Flexible Form Factor
flexible design • Connects to Smart Device
• Integrated PCB antenna • Zero-Calibration to ±0.1°C Accuracy
• Temperature updates every second
Applications
• Medical Sensor Patches
• Multiparameter Patient Monitors
• Smart Patches
Skin
Tools & Resources Temperatur
e
• TIDA-01624 and/or Tools • Device Datasheets: TMP117
Folder ‒ TMP117 I2C
• Design Guide ‒ CC2640R2F
• Design Files: Schematics, BLE MCU
BOM, Gerbers, Software, etc. CC2640R2F
TMP117x
Ultra-High Accuracy Digital Temp Sensor with integrated non-volatile memory
Features Benefits
Accuracy Ultra-high Accuracy
• Meets ASTM E1112 & ISO medical standards:
Accuracy • 0.1°C acc. range 35.8°C to 42°C
TI Part Accuracy (°C) Full Range • No calibration needed; NIST Traceable
Integrated Non-volatile memory
TMP117M ±0.1oC @ (30oC to 45oC) ±0.2oC @ (0oC to 85oC) • Store configuration even after losing power
±0.1oC @ (-20oC to ±0.3oC @ (-55oC to • 64 Bits of general purpose scratch pad memory
TMP117 50oC) 150oC) Low Power Consumption
TMP117N ±0.2 C @ (-40 C to
o o ±0.3 C @ (-55oC to
o • 3.5uA Average Iq @ 1Hz; serial bus inactive
100oC) 150oC) • 150nA Shutdown Iq; serial bus inactive
Digital feature & I2C Interface:
• 16-bit Resolution (0.0078°C) • Programmable Temperature Alert & Offset value
• Minimum PSRR: 1LSB = 7.8 m°C/V • Soft Device Rest
Integrated EEPROM Smallest Package: 6 PIN, QFN & CSP
Applications
• Gas Meter • Wearables
• Medical • Instrumentation & Test
• Cold Chain • Thermocouple – Reference
TIDA-010040 / Alarm tone generator reference design
Features Benefits
• Provides a solution that can be used for producing auditory • Timing parameters are all adjustable via firmware
alarms described in the IEC60601-1-8 medical specification. • Minimal code-space used allows for low-cost MSP430
• Capable of outputting low, medium, and high priority alarms with • Booster pack design makes for easy setup
software-adjustable rise/fall time, pulse duration, pulse spacing,
and burst spacing
• Can output 8 different alarm melodies as described in the
IEC60601-1-8 spec.
Target Applications
• Coincidence Detector confirms if speaker is actually making • Multiparameter Patient Monitor Infusion Pump
correct sound • Dialysis Machine AED Surgery Equipment
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Key Design Challenge: Technical details
IEC60601-1-8 based medical alarm tone generation & coincidence detection
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TIDA-010040 – Coincidence Detection
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