ST Microelectronics S R L MHBGW1 Bodyguardian Control Unit User Manual Body Gateway

ST Microelectronics S.R.L. Bodyguardian Control Unit Body Gateway

Contents

Product literature

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SPMHBGW1
Body Gateway Electronic patch
Data brief 1.1
Features
Single Lead AFE for ECG with self calibration
circuitry
Bio-impedance
STM32F M3 Cortex ARM cortex
BT radio class 2: STLC 2584
Digital 3 axis Accelerometer: LIS 331 DLH
External parallel NAND FLASH 2Gbit
Battery Level sensing
Rechargeable battery LiPo 380 mAh
3 LEDs
Mechanical ON/OFF button
Functions
• Heart rate detection
• One lead ECG recording and
transmission
• Physical activity estimation
• Breathing rate measurement
• Body position detection
Applications
• Elderly people home monitoring
• Chronic cardiac disease monitoring
• Event monitoring
• Single lead holter
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Contents
1 Body Gateway device description ..................................................................................................................... 3
2 Body Gateway device architecture .................................................................................................................... 4
2.1 Hardware: ................................................................................................................................................... 4
2.2 Embedded SW Framework: ........................................................................................................................ 4
3 Embedded SW Framework ............................................................................................................................... 5
3.1 Connectivity: ............................................................................................................................................... 5
3.2 Embedded Data Aggregator........................................................................................................................ 5
3.2.1 ECG: extraction of .............................................................................................................................. 5
3.2.2 Bio-impedance: extraction of .............................................................................................................. 5
3.2.3 Accelerometer: extraction of ............................................................................................................... 5
4 Operating modes: ............................................................................................................................................. 6
5 Physiological parameters & personalization features ........................................................................................ 7
5.1 Parameters: ................................................................................................................................................ 7
5.2 Personalization: .......................................................................................................................................... 7
6 Body Gateway mechanical dimension .............................................................................................................. 8
6.1 Body Gateway device ................................................................................................................................. 8
7 Power consumption......................................................................................................................................... 10
7.1 Usage model example 1: streaming mode ................................................................................................ 10
7.2 Usage model example 2: monitoring mode ............................................................................................... 10
8 ECG EC38 signal snapshot ............................................................................................................................ 11
9 Regulatory Compliance ................................................................................................................................... 12
Safety and EMI Approval, ................................................................................................................................... 12
10 Revision history ......................................................................................................................................... 12
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RoHS compliance
ST modules are RoHS compliant and comply with ECOPACK® norms.
1 Body Gateway device description
The Body Gateway (BGW) Devices is a wearable electronic, battery operated device that is worn on the
chest for the acquisition, recording and transmission of physiological parameters to external devices which
can analyze or forward the data to additional storage elements or system.
The BGW device is also capable to record symptomatic and asymptomatic events and is indicated for
ambulatory monitoring of non lethal cardiac arrhythmias.
Additionally, resident in the Body Gateway device is a heart rate, respiration rate and activity level
calculation algorithm, which allows the system to manage information messages from/to the Server
according to specific settings defined by the physicians/operators.
The device is a part of a Multi-parameter Analysis System, Body Gateway System (BGW system) and
communicates via a BT radio link with the external device. Specification of BGW System is beyond the
scope of this document.
At its heart is a 32-bit ARM Cortex microcontroller with 768 kByte Flash, chosen for its flexible architecture
and low power processing capability. Bluetooth radio was selected for connectivity because its availability in
most commercial mobile phones ensures proper coverage and patient access.
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2 Body Gateway device architecture
2.1
Hardware:
The hardware architecture for the BGW device is shown here below.
2.2 Embedded SW Framework:
The embedded SW Frameworks includes a RT OS, board support package, proprietary data aggregation
algorithms, embedded memory management system, a BT stack and proprietary data exchange protocol.
This SW is modular and provides an application interface to allow integration in customer specific
environment including the possibility to plug in proprietary algorithms for physiological data elaboration.
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3 Embedded SW Framework
3.1 Connectivity:
Bluetooth Radio class 2
BT supported profiles: SPP
Point to point link to a PC or to any BT enabled device, supporting SPP service, both as a
client and as a server
Proprietary data exchange protocol on top of SPP designed to optimize power
consumption minimizing packets overhead.
3.2 Embedded Data Aggregator
3.2.1 ECG: extraction of
· Heart rate
· RR peak variability
· Heart Rate variability
· Electrode detachment alert
3.2.2 Bio-impedance: extraction of
· Breathing rate
3.2.3 Accelerometer: extraction of
· Activity level index
· Body posture
Baselines and thresholds are programmable for 3.2.1., 3.2.2., 3.2.3. with hysteresis to avoid false
alerts.
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4 Operating modes:
Platform can operate in 4 modes:
a) Power down mode : BGW device is completely switched off
b) Idle mode: the BGW device is visible and connectable to the remote unit through the BT link
c) Streaming Mode: is when the Body Gateway is powered ON and sampling the data as specified in
the Configuration Settings, sending them directly to the External Device with periodicity specified by
the last configuration commands received from the External Device.
d) Monitoring mode: is when the Body Gateway is powered ON, gathering and storing in the internal
memory data at the frequency specified in the Configuration Settings, and sending the data as
requested by the Associated Device.
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5 Physiological parameters & personalization features
5.1 Parameters:
Heart rate
Heart rate reliability
RR interval variability
Breathing rate
Activity level
Body position
Other available data:
ECG raw
Z0 bio impedance
Electrode reliability
Battery level
5.2 Personalization:
Available data and parameters depends on the selected operative mode
Streaming mode
Raw Data:
· ECG (128 or 256 Hz)
· 3-axis accelerometer
(32Hz or 64Hz or 50 Hz)
· dZ bioimpedance (32
Hz)
· Z0 bioimpedance (32Hz)
Derived values:
· Heart rate values,
· Heart rate reliability,
· Breathing rate values,
· Activity level,
· RR interval variability,
· Body position values,
· Battery level
Monitoring mode
Raw Data
o ECG (128 or 256 Hz)
Derived values
o Activity level
o Body position values
o Breathing rate values
o Heart rate values
o Heart rate reliability
o RR interval variability
o Battery level
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Signals and Parameters
Streaming Mode
Monitoring mode
ECG raw
128/256 Hz
128/256 Hz
Heart Rate
1 each 10-15-30-60 secs
1 each 10-15-30-60 secs
Heart Rate Reliability
1 each 10 secs
1 each 10 secs
R-R Variability
1 each 10 secs
1 each 10 secs
XYZ raw
50.0 Hz
-
Activity level
1 each 5-10-15-30-60 secs
1 each 5-10-15-30-60 secs
BIOIMP-Z0 raw
32 Hz
-
BIOIMP-DZ raw
32 Hz
-
Breathing Rate
1 each 15-30-60 secs
1 each 15-30-60 secs
Battery Level
1 each 10-15-30-60 secs
1 each 10-15-30-60 secs
6 Body Gateway mechanical dimension
6.1 Body Gateway device
BGW device is water resistant IPx4
Mechanical dimension:
• Weight: 35g
• Size: 59 x 50 x 16.4mm
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7 Power consumption
7.1 Usage model example 1: streaming mode
Continuous data acquisition, processing and real time transmission (ECG raw signal, Bio-impedance
signal, accelerometer data raw signal, HR, BR, Activity level, RR variability, HR reliability and battery
level)
Using a 3.7V 380 mAh rechargeable battery, battery will last in 16Hours
7.2 Usage model example 2: monitoring mode
Continuous data acquisition, processing and storage (ECG raw signal, Bio-impedance signal, HR, BR,
Activity level, RR variability, HR reliability and battery level), wireless uploading of all physiological
parameters plus 5 minutes ECG and bio-impedance raw data per hour
Using a 3.7V 380 mAh rechargeable battery, battery will last in 40 hours
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8 ECG EC38 signal snapshot
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9 Regulatory Compliance
FCC
FCC ID: S9NMHBGW1
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.
CE
Safety and EMI Approval,
Compliance with
IEC 60601-1
IEC 60601-1-1
IEC 60601-1-2
IEC 60601-1-4
IEC 60601-1-6
IEC 60601-2-47
IEC 60601-2-49
IEC 60529
EC38
EC57
UL 60601-1
CAN/CSA C22.2
10 Revision history
Date
Revision
Description of changes
10/07/2011
1.0
First issue.
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