Operation Description

FCC ID: S9NMHBGW1

Operational Description

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FCCID_1733239

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 Applications • Heart rate detection • Elderly people home monitoring • One lead ECG recording and • Chronic cardiac disease monitoring transmission • Event monitoring • Physical activity estimation • Single lead holter • Breathing rate measurement • Body position detection 1/12

SPMHBGW1 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 2/12

SPMHBGW1 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. 3/12

SPMHBGW1 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. 4/12

SPMHBGW1 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. 5/12

SPMHBGW1 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. 6/12

SPMHBGW1 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 Monitoring mode Raw Data: Raw Data · ECG (128 or 256 Hz) o ECG (128 or 256 Hz) · 3-axis accelerometer Derived values (32Hz or 64Hz or 50 Hz) o Activity level · dZ bioimpedance (32 o Body position values Hz) o Breathing rate values · Z0 bioimpedance (32Hz) o Heart rate values Derived values: o Heart rate reliability · Heart rate values, o RR interval variability · Heart rate reliability, o Battery level · Breathing rate values, · Activity level, · RR interval variability, · Body position values, · Battery level 7/12

SPMHBGW1 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 8/12

SPMHBGW1 9/12

SPMHBGW1 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 10/12

SPMHBGW1 8 ECG EC38 signal snapshot 11/12

SPMHBGW1 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. 12/12

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Document Created: 2012-02-28 09:44:02
Document Modified: 2012-02-28 09:44:02
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