BioHarness 3 User Manual - Zephyr Technology Corporation
Contents
1. The device can be configured to transmit data by Bluetooth and or 802 15 4 anjd or log data to internal memory Powering on the device will initiate either or both modes BioHarness Module in Charge Configuration Cradle 3 4 1 Set Transmit Mode Using the Zephyr Config Tool 1 Open the Application 2 Click the Select Device button and use the pulldown to select the BioHarness Module identified by its serial number This list will automatically populate with the serial number of any device connected to the PC Device Selection BHTUOTD256 USB Page 24 of 46 Ph 1 443 569 3603 Fax 1 443 926 9402 Web www zephyanywhere com 9700 0079 Zephyr Technology 2012 2012 09 12 Zephyr technology BioHarness 3 0 User Manual 3 To activate transmitting modes go to the User Config tab of the ConfigTool and check the Bluetooth Enable and or ECHO Enable ECHO is the Zephyr proprietary name for the 802 15 4 transmitting mode E Log Enable W Bluetooth Enable Visual Feedback Enable i Button Enable When Wom W ECHO Enable Audio Enable i Team System Enable ECG Polarity Invert zu Format 3 4 2 Bluetooth 1 a adu tab in the LEE CH Tool allows the see to be configured Network ID BHT390618 s Set Nath Net Id Bluetooth detectable i Link Settings Link Timeout ms 30000 Lifesign Period ms 3000 Update MN TUTTI i 2 Network ID the label by which the device will be i2. Page 29 of 46 Ph 1 443 569 3603 Fax 1 443 926 9402 Web www zephyanywhere com 9700 0079 Zephyr Technology 2012 2012 09 12 Zephyr technology dBioHaress 3 0 User Manual 3 6 Fit BioHarness Module to Strap The BioHarness Module attaches to the chest strap by insertion into a custom receptacle A cutout on the top edge of the device allows for finger leverage to remove from the receptacle and a ridge in the receptacle and matching groove in the device itself prevent improper insertion Three metal rivets locate through the receptacle and form conductive paths to the ECG and breathing sensors These rivets make contact with alloy spring contacts on the rear of the BioHarness module Check the springs for contamination before attaching the module LN Page 30 of 46 Ph 1 443 569 3603 Fax 1 443 926 9402 Web www zephyanywhere com 9700 0079 Zephyr Technology 2012 2012 09 12 Zephyr technology BioHaress 3 0 User Manual 3 7 Fit Strap to Subject In order that the BioHarness Module may perform as it was designed the chest strap must be fitted in the correct location with an appropriate level of tension around the subject s torso 1 For optimum performance lightly moisten the sensor pad surfaces with water to aid conductivity Press the water into the pad if beading on the surface occurs 2 To adjust tension wear the strap with the
3. 7 3 1 SUR te et E 43 er OW c 43 FA COMP eT tm 44 FESW esM EEERRE 44 PO Lese E 45 Page 4 of 46 Ph 1 443 569 3603 Fax 1 443 926 9402 Web www zephyanywhere com 9700 0079 Zephyr Technology 2012 2012 09 12 Zephyr technology BioHarness 3 0 User Manual 1 General Information This documentation contains instructions for safe use and a technical description of the BioHarness 3 0 device Operators of the device should read this manual in its entirety prior to use The components referred to in this manual are Component Part Product Number 9800089 BioHarness Bluetooth Module Electronics sensor 9800 0189 BioHarness Bluetooth Firmware Version 1 3 12 0 OBAO 1 O BioHarness Chest Strap Sizes Small XS M Large M XL 9600 0189 9600 0190 BioHarness Shoulder straps optional one size adjustable 9600 0117 BioHarness Charge Cradle amp USB Cable single device 9600 0257 CLASSIFICATIONS EC38 Type Type 3 The BioHarness Module is internally powered when in patient monitoring mode IP55 rated against ingress should not be used for swimming or other water based activities Does not need to be sterilized as part of normal operations Will be used for non continuous operation Page 5 of 46 Ph 1 443 569 3603 Fax 1 443 926 9402 Web www zephyanywhere com 9700 0079 Zephyr Technology 2012 2012 09 12
4. pow activ E L cH Moderate activity walkjog lt 08 95 1 5 6 Accuracy greater of 100 uV or A United States Army Research Institute of Environmental Medicine Continued on next page Page 41 of 46 Ph 1 443 569 3603 Fax 1 443 926 9402 Web www zephyanywhere com 9700 0079 Zephyr Technology 2012 2012 09 12 Zephyr technology BioHarness 3 0 User Manual Paramterr JL Notes Values uo ECCE Mm ie uos Sampling frequency Ill 25 H2 Rane III S3 Nosignalresponsetime 15 S Step change response time LL 15 ee j Sampling frequency IB 1 o 8 o Rane J IL 10 O Stabilization Time T d 20 minutes Sampling Frequency 100 Bz Range any axis II ae 46 g Bandwidth Ill 50 Bz Sensitivity Le 12 mg VMU vector magnitude units 9 16 g Epoch II LI 1 S Bandwidth IL O06 9 HS Dynamic Range any axis IL 16 16 g Sensitivity 10 J 1 mg Noise Ill 72 mg Postue 4 J 24 0 0 000 0 00000000 Reporting frequency Il 1 Dynamic Range JI 10 80 Epoch LL LI Sensitivity 1 8 1 Recommended storage temperature 20 C Notes 7 Breathing Rate Accuracy for defined conditions based on USARIEM guidelines Accuracy Condition aver
5. then indicated activity level will reflect the motion of the vehicle rather than the subject Ph 1 443 569 3603 9700 0079 Page 36 of 46 Fax 1 443 926 9402 Web www zephyanywhere com Zephyr Technology 2012 2012 09 12 technology BioHarness3 User Manual 5 Maintenance amp Cleaning The BioHarness Module and Chest Strap contain no user serviceable parts Return the components to your distributor or the manufacturer in the event of failure or need for battery replacement 5 1 BioHarness Module e Visually inspect the device before use to check for signs of damage or contamination to the casing and spring contacts e Check that the spring contacts on the rear of the case have not been prised proud of the case surface which may cause them to catch on the USB charge configuration cradle when the device is inserted Clean with a damp cloth when needed Use mild detergent if necessary Avoid leaving in direct sunlight for long periods The device does not require calibration The BioHarness Module does not require sterilisation or disinfection for normal use Do not autoclave or use sterilising tablets 5 1 1 Battery Lifetime and Replacement The BioHarness Module is powered by an internal rechargeable Lithium Polymer cell Battery is not user replaceable Return to your distributor for replacement Only trained personnel should change a battery Expected battery charge cycles
6. to the subject and adjust for fit and comfort e Power on the device using the front button e Confirm operation using the LED indicators e Confirm data reception using suitable software Page 21 of 46 Ph 1 443 569 3603 Fax 1 443 926 9402 Web www zephyanywhere com 9700 0079 Zephyr Technology 2012 2012 09 12 Zephyr technology BioHarness 3 0 User Manual 3 2 Initial Inspection Before operation of the BioHarness and strap check the following BIOHARNESS MODULE Damage to casing e g cracks scuffing or distortion due to heat Severe physical impact to the device may compromise subsequent accelerometer performance Removal or peeling of labels Loose contact springs Shake the device and listen for any loose or detached internal components Grease or dust contamination of contact springs or USB contact pins Contamination may affect conductivity clean with water and a mild detergent Dry effectively BIOHARNESS CHEST STRAP Contamination of the strap by perspiration or external factors Perspiration buildup may show as faint salt deposits if the strap is not rinsed in water after heavy use Salt contamination on the conductive sensor surfaces may compromise performance of the system Full washing instructions are included in the Maintenance Section 5 1 Excessive scuffing or any tearing of the sensor surfaces Failed or loose stitching Page 22 of 46 Ph 1 443 569 3603 Fax 1 443 92
7. 0 User Manual 6 Accessories and Replacement Components The following are Zephyr replacement component and accessory parts BioHarness Bluetooth Developer Kit includes 3 chest straps BioHarness Bluetooth Module Electronics sensor BioHarness Chest Strap Small XS M BioHarness Shoulder straps optional one size adjustable 9600 0117 BioHarness Charge Cradle amp USB Cable for single device 9600 0257 Further component combinations such as BioHarness Module Strap additional units and 5 or 50 packs of chest straps are also available Consult a Distributor for more information BioHarness Chest Strap Large M XL 9600 0265 Page 39 of 46 Ph 1 443 569 3603 Fax 1 443 926 9402 Web www zephyanywhere com 9700 0079 Zephyr Technology 2012 2012 09 12 technology BioHarness 3 0 User Manual 7 Technical Specifications Unless otherwise stated Temperature 25 C Pressure 1 ATM 7 1 Electrical Power Supply Type Rechargeable Lithium Polymer No of cells 1 Nominal Voltage 3 7V Charge Source PC USB or USB wall charger 7 2 General amp Physiological Parameter CT Notes Values Min Ty Ma Accy Unit General J Logging capacity ll IL 500 X Doug Powrsuplyvllag USB 48 5 898 V Battery Life Radio transmitting 2 12 24 hs BatteryL
8. 443 569 3603 Fax 41 443 926 9402 Web www zephyanywhere com 9700 0079 Zephyr Technology 2012 2012 09 12 Zephyr technology BioHaress 3 0 User Manual 3 9 Transmitted Data Data output from the device is described fully in the General Comms Link Specification 1 Data output is in the form of a number of messages each of which can be enabled or disabled Details on how to do this are included in the above document For a full description of all transmitted parameters and data packet options refer to the BioHarness 3 0 Data sheet 3 10 Logged Data Logging modes can be configured using the Zephyr Configuration tool Available modes are e General data default General ECG General Accelerometer Summary data Summary Waveform When device memory is full older logs are overwritten automatically Alternatively all logs can be deleted using the Zephyr Configuration Tool For a full description of all logged parameters and log format options refer to the BioHarness 3 0 Data Sheet Page 34 of 46 Ph 1 443 569 3603 Fax 1 443 926 9402 Web www zephyanywhere com 9700 0079 Zephyr Technology 2012 2012 09 12 technology oBioHearness3 0 User Manual 4 Interpretation of Data The BioHarness Bluetooth device intended use is to provide contextual remote physiological information It should be used as an aid in the diagnostic process The device may indica
9. Ene sue n emissions were below P applicable limits Compliant Measured Voltage Fluctuations amp Flicker ETSI EN 301 489 1 Section 8 6 EN 61000 3 3 1995 emissions were below AC Mains Input Port applicable limits IMMUNITY RF Electromagnetic Field ETSI EN 301 miss Compliant Measured 80 1000 MHz ETSI EN 301 489 1 Section 9 2 EN 61000 4 3 2006 emissions were below amp 1400 2700MHz applicable limits Electrostatic Discharge ESD ETSI EN 301 489 1 Section 9 3 EN 61000 4 2 2001 emissions were below applicable limits Fast Transient Common Mode ETSI EN 301 489 1 Section 9 4 EN 61000 4 4 2004 emissions were below applicable limits Compliant Measured Radio Frequency Common Mode ETSI EN 301 489 1 Section 9 5 EN 61000 4 6 2005 emissions were below applicable limits Compliant Measured Transient amp surges in the ISO 7637 2 2004 12 24 Compliant Measured vehicular environment VDC i M applicable limits Compliant Measured Voltage dips amp interruptions ETSI EN 301 489 1 Section 9 7 EN 61000 4 11 2004 emissions were below applicable limits Compliant Measured Surges ETSI EN 301 489 1 Section 9 8 EN 61000 4 5 2006 emissions were below applicable limits DISPOSAL AT END OF LIFE The BioHarness Module charge cradle and chest strap contain no hazardous components All electrical components are lead free However where specific provision is made in a particular region for disposal and recycl
10. Max Repeaters defines the maximum number of Zephyr ECHO receiver units which can be used within a PSM system 5 The maximum number of repeater hops allowed within a PSM system 6 Beacon Interval factory configured 3 4 4 SetLogging Mode In the Zephyr Config Tool User Cfg tab 1 Setthe Logging Format from the list available Update Configuration General and ECG General and Accelerometer Summar 2 The Summary Logging formats are only available on BioHarness 3 0 versions Page 26 of 46 Ph 1 443 569 3603 Fax 1 443 926 9402 Web www zephyanywhere com 9700 0079 Zephyr Technology 2012 2012 09 12 technology BioHarness 3 0 User Manual 3 4 5 Subject ROG Thresholds The BioHarness module outputs a subject status indication which has the values e Green subject s physiological parameters are within thresholds as configured e Orange one or more of the subjects parameters have crossed the configured threshold values The subject s data should be monitored more closely e Hed one or more of the subjects parameters have exceeded threshold values for a sustained period configurable The subject s physiological parameters should be monitored closely and confirmation sought if there is an indication of stress fatigue or trauma ROG THRESHOLD AND ALERT STATE LOGIC Subject Status is determined by analyzing Heart Rate Breathing Rate and Ac
11. RW WOE IO GARG lO OPER Roc 11 22 IHESU III carps cats see E P 12 R NEM o illo de Oe e EE 12 2 2 20 Charging and Configuration Mode 13 DVS LOIN SO MID ONC E 15 2569 MEM S eui idi SS e EE 15 292 BIOHSIiess Ie SES E 16 2 3 3 BioHarness Charging and Configuration Cradle cccccccccccccseeeeeeceeeeeeeeeeeeeseeeeseaeeeeeeeesaaseeees 18 2 3 4 BioHarness Charge Configuration Lead 18 DOV elie eI EE 19 241 Bielooli FEST ADDBIICAUOE EE 19 242 el CONIO Reie tM 20 2 4 8 BioHarness Log Downloader nennen nennen nnn nnns nnn nnns nna nnns 20 EEG ucLIq09 21 ENER ee H 21 du ALIMAMA SO CCION EE 22 SONG aciei eric Y e e a 23 3 4 Check BioHarness Module Contouraton nennen nnne nnne nnn nnne nnn nnns 24 3 4 1 Set Transmit Mode 24 SF S E ee NRI kt M 25 2 no EE LN oe gO m 26 3 4 4 Set Logging MOC RR 26 3 4 5 Subject ROG Thresholds ccccccccssssececceesseeeecceeesececcceeueeeeecceausececsseausesecsseageeeeeseaggeeesessagseeees 27 3 4 6 ROG Threshold Default Values nnnm nnnnnn nnns nain nnns snas nns 28 E CONN SUIS 6 ellc REI dE 29 3 6 Fit BioHarness Mod
12. main attachment hook and tension slider adjuster initially at the front 3 The strap should be a snug fit so as not to move when the subject is active A tension loop is sewn at the rear of the strap When the subject has inhaled and the chest fully expanded the tension loop should be flush with the main strap it is shown un tensioned in the image 4 When size is adjusted rotate the strap so that the device is located under the subject s left armpit with Zephyr brand label at the front the brand label may not be exact centre 5 When correctly located a line through the centre of the device should be directly beneath the subject s arm pit or slightly 1 2 to the rear Page 31 of 46 Ph 1 443 569 3603 Fax 1 443 926 9402 Web www zephyanywhere com 9700 0079 Zephyr Technology 2012 2012 09 12 Zephyr technology JBioHaress 3 0 User Manual 3 8 Power On Off BioHarness Module e Power On the BioHarness Module by depressing the center front of the device The button has a tactile click to indicate switching Hold the button depressed until the all four LEDs flash e he device may be powered on before or after attachment to the strap However attaching the device while it is recording and or transmitting data produces an electrical noise spike as contact is made It may not be desirable for this noise spike to be present in any recorded data If this is the case
13. 00 00 00 00 00 00 9500 0084 Boot Part Number BT Access Point 2 00 00 00 00 00 00 BT Access Point 3 00 00 00 00 00 00 BT Access Point A 00 00 00 00 00 00 BT Access Point 5 00 00 00 00 00 00 9500 0085 App Part Number e d7ba a7 9e 82 Unit MAC Address BH BHT001026 Bluetooth Name i 00 00 00 00 00 00 22 2 2012 14 49 33 Date Time BT Access Point 6 BT Access Point 7 00 00 00 00 00 00 BT Access Point 8 00 00 00 00 00 00 Apple iOS Device 00 00 00 00 00 00 Named Bluetooth Devices to Call Call Friendly Name PIN Code Class ID BT Device 0 Set BT Dev 0 4 848V 100 Battery Status Delete Log File Switch Unit Off Reset to Factory Defaults Page 11 of 46 Ph 1 443 569 3603 Fax 1 443 926 9402 Web www zephyanywhere com 9700 0079 Zephyr Technology 2012 2012 09 12 technology Botisress 3 0 User Manual 2 2 System Overview The BioHarness Bluetooth operates in two modes 2 2 1 Monitoring Mode zb et wcrccxEx d Raab ap bc H wu noct 920 1 A at Ta 1 zc KE zuv oxzvo lt Jesu4oued IR FSB Wiel A oooor ooo Vu de PS 9 g g i g g 9 H t g e Saa g EN vro tans Sag Peer 5 TT es GREEN volts 3 778V 4 C Charge 29 3c Worn Con 005 s Co 0 BioHarness Module attached Physiological data sent by Data displayed on PC to chest strap with optional Bluetooth radio protocol or shoulder straps 802 15 4 protocol e Power Suppl
14. 012 09 12 Zephyr technology BioHarness 3 0 User Manual 2 4 Software Utilities The BioHarness Bluetooth product is normally supplied as a software developer s kit SDK Included the SDK along with the documentation described in Section 1 1 are a number of software utilities Their installation and operation is described in the BioHarness Bluetooth Developer Kit User Manual 3 2 4 1 Bluetooth Test Application HA Bluetooth BioHarness Test Application 9500 0091 V1C 2 1 0 1 Communications Configuration e E Accelerometer Packet Enable g True D Enable raw True m El Breathing Packet Rate 12 9bpm Activit 0 Enable True Amp Mag Pea 0 E E mie Facil Noise Vert Peak 0 Conf Vert Min 1 c Lat Peak 0 E Lat Min 0 sagt P eak 0 Enable breathing waveform data Sagt Min 0 packet transmission Battery amp RF Status Status i Posture 24 Skin Volts 3 778V ADCL 415 Device 4 Charge 29 ADC2 419 Est Core 37 3 worn Conf 100 ADC3 481 RSSI 10dB sys Conf 100 TX Power 3dBm Events Recieved Bluetooth Connect Manual Connect Disconnect Debug Output e Displays all summary physiological parameters Heart Rate Breathing Rate Temperature Posture Activity Level Subject Status as well as the battery level of the device Displays summary communication data as seen in the General Status window above Establishes a Bluetooth connection with the device Enables or dis
15. 6 9402 Web www zephyanywhere com 9700 0079 Zephyr Technology 2012 2012 09 12 Zephyr technology BioHarness 3 0 User Manual 3 3 Charge Battery BioHarness Module in Charge Configuration Cradle Orange LED flashes while device is charging Charge by placing the BioHarness Module in the charging cradle and connecting to a PC USB Port An orange amber LED will flash on the front of the device when charging The LED will stay illuminated when fully charged Charge times o 1hourto 9096 capacity o 3hrs to 10096 capacity e When in operation the orange LED will flash when battery level is greater than 30 of a full charge When constantly illuminated charge is less than 30 When the orange LED extinguishes charge is below 10 e Use only the wall charge unit supplied with the system to charge the device from a domestic power supply e Charging at high temperatures gt 45 C 113 F has risk of fire or explosion Page 23 of 46 Ph 1 443 569 3603 Fax 1 443 926 9402 Web www zephyanywhere com 9700 0079 Zephyr Technology 2012 2012 09 12 Zephyr technology mBioHaress 3 0 User Manual 3 4 Check BioHarness Module Configuration The BioHarness Module stores previous configurations To confirm or change a previous configuration connect the BioHarness module in its cradle to a PC hosting appropriate software such as the Zephyr Config Tool supplied with the SDK
16. Zephyr technology SBioHaress 3 0 User Manual 1 1 Documentation This device is supplied as a component of the Zephyr Bluetooth BioHarness Software Developer s Kit SDK The SDK contains this guide as well as additional documentation BioHarness BT Comms Link Specification 1 All messages needed to 9700 0110 communicate with the device by Bluetooth or direct serial USB connection All data packet descriptions meruere enum umet em 07 the device s internal memory ee imu e E Manual 3 supplied with the SDK BioHarness Bluetooth API Guide 4 Overview of Data Packet 9700 0027 structure and protocols for communicating with the device BioHarness 3 Data Sheet 5 opecifications of device 9700 0136 BioHarness Side Strap Data Sheet 6 opecifications of strap 9700 0024 BioHarness BT Android API User Guide 7 Android Application Programming 9700 0150 Interface Instructions BioHarness MATLAB Script File Description Instructions for converting csv 9700 0151 8 data file output for input to MATLAB 3 party analysis software Event Messaging System 9 Description of Msgs recorded in 6700 0157 Event Log This Guide and the documents above is included as a component of the BioHarness Bluetooth Developer s Kit They are intended to provide information to integrators who wish to incorporate the BioHarness Bluetooth into a physiological monitoring product These documents are not intended as end u
17. Zephyr technology BioHarness 3 0 User Manual technology BioHarness 3 0 User Manual For support or further information on this product contact Zephyr Technology 1 Annapolis St Suite 200 Annapolis MD 21401 USA Phone 1 443 569 3603 Fax 1 443 926 9402 Web www zephyranywhere com Email supportQzephyrtech zendesk com sales zephyranywhere com This document may be subject to change without notice 2012 06 26 Update hardware and firmware part nos Add 802 15 4 specifications 2012 07 03 Add new FCC ID update battery life label 2012 07 31 Update label intended use 2012 08 20 Correct erroneous IC ID 2012 09 12 Clarify Rear Label Page 2 of 46 Ph 1 443 569 3603 Fax 1 443 926 9402 Web www zephyanywhere com 9700 0079 Zephyr Technology 2012 2012 09 12 Zephyr technology BioHarness 3 0 User Manual Contents 1 GENERAL INFORMATION aaeanaannnnnnnnnnnnnnnnnnnnssnnnnrrrnnsssnnrrrrressrnnnrrrrrossnnrrrrrenssnnnrrrreonsnnnterreossrnnrtnrernsnnnrrnreennennnni 5 PPP ere CAIN SU el AON NIRE 6 1 2 Warning and Safety Notices ccccccccccseeeceeeceeeeeeeeeeeaeeeeeeeeeeaeeceeeeseeseeeeeseeeeeeeeesseaaeeeeesseaeeeeessaeeeesessneeeeeesas 7 13 aile KR c eee 9 1 4 COMM AIIGICATIONS Am 10 to Table of oy laneo EE 10 2 TECHNICAL aleet DEE 11
18. Zephyr Technology 2012 2012 09 12 Zephyr technology mBioHaress 3 0 User Manual 2 2 2 Charging and Configuration Mode CHARGING amp CONFIGURATION MODE BioHarness Module in Charge Configuration Cradle USB Charge Configuration Lead CHARGING MODE Power Supply the BioHarness module receives a PC USB input of 5V DC The BioHarness Module is located in a charging configuration cradle It cannot be fitted to a strap worn by a subject in this mode An orange LED on the front of the flashes when the device is charging The orange LED is constantly illuminated when the device is fully charged The device cannot be over charged Charging times 1 hour to 9096 capacity 3 hours to 10096 capacity Page 13 of 46 Ph 1 443 569 3603 Fax 1 443 926 9402 Web www zephyanywhere com 9700 0079 Zephyr Technology 2012 2012 09 12 Zephyr technology s ABioHaress 3 0 User Manual CONFIGURATION MODE Power Supply PC USB input 5V DC The BioHarness Module is located in a charging configuration cradle It cannot be fitted to a strap worn by a subject in this mode It is connected to a USB Port of a PC for configuration Configuration Parameters are o Transmit and or logging mode Bluetooth discoverability Device Network ID Bluetooth link configuration settings Internal Date Time reset o Disable button power off while worn by subject The device battery is also charged whi
19. ables the data packets being transmitted by the device Generates CSV files of streaming data when the application is closed see the Data Output section 3 10 for more information The utilities provided by Zephyr as part of the software developer s kit are intended for use by developers to confirm device performance They are not intended as end user utilities Developers who produce end user software for use with the Zephyr Bluetooth BioHarness are themselves responsible for any compliance requirements of any end user software they have created Page 19 of 46 Ph 1 443 569 3603 Fax 1 443 926 9402 Web www zephyanywhere com 9700 0079 Zephyr Technology 2012 2012 09 12 Zephyr technology BioHarness 3 0 User Manual 2 4 2 Zephyr Config Tool Ed Zephyr Config Tool v1 0 7 0 Device 5elech e Buetoolh Subject ifo BHT001026 USB Refresh Device List Log Enable Bluetooth Enable Visual Feedback Enable Read Only Data Button Enable When Wom 802 15 4 Enable Audio Enable v12 1 0 Boot Software Version Team System Enable ECG Polarity Invert v1 1 15 0 App Software Version Log Format BHTO01026 Serial Number 9800 0153v3a Hardware Part Number 29500 0034 Boot Part Number 5500 0085 App Part Number elld7ba a7 3e 82 Unit MAC Address BH BHTO01026 Bluetooth Name 22 2 2012 15 37 14 Date Time DIV 100 Battery Status Heads all software and hardware properties of the device Displays and configures Bluetooth conne
20. age every 15 Bpm seconds EC AEN NN RN emulator 3 Lowactivity static 02 95 5 3 95 D ivity 90 12 5 00 2 5 5 12 range 6 25 bpm 8 Min device transmitting Max device logging 9 Vector Magnitude Units 3 axis sampled at 125 Hz averaged to 1 second epoch 10 0 vertical 90 horizontal 180 inverted Subject anterior inclination is a positive value posterior is negative Medio lateral inclination does not affect sign of posture value Page 42 of 46 Ph 1 443 569 3603 Fax 1 443 926 9402 Web www zephyanywhere com 9700 0079 Zephyr Technology 2012 2012 09 12 Zephyr technology 7 3 RF 7 3 1 Bluetooth Compliance Supported Profile Discoverability Frequency Output Power Operating Range Sensitivity Antenna Type 7 3 2 802 15 4 Compliance Frequency Output Power Operating Range Sensitivity Max Data Rate Modulation Type opread Spectrum Ph 1 443 569 3603 9700 0079 BioHarness 3 0 User Manual Version 2 1 EDR Serial Port Configurable 2 4 to 2 835 GHz 10 dBm Up to 300ft 100m Up to 300yds with long range receiver antenna Dependent on Bluetooth receiver components 91 dBm Internal IEEE 802 15 4 2 405 2 480 GHz 100mW Up to 300 yds 275m 89 dBm 250 kbps OQPSK DSSS Page 43 of 46 Fax 1 443 926 9402 Zephyr Technology 2012 Web www zephyanywhere com 2012 09 12 Zephyr technolo
21. attach the device to strap before powering on e To power off the device depress and hold the control button until the LED stops flashing 3 8 1 Data Stabilisation Times Time to stable data output Device ON worn by subject 15 seconds Activity Level Red Orange Green Page 32 of 46 Ph 1 443 569 3603 Fax 1 443 926 9402 Web www zephyanywhere com 9700 0079 Zephyr Technology 2012 2012 09 12 Zephyr technology BioHarness 3 0 User Manual 3 8 2 Device LED Behaviour The BioHarness module can operate in three modes e Transmit data by Bluetooth Log data to internal memory no transmit e Both Transmit and log the same data simultaneously The device can be configured to these modes using the BT Config Tool DEVICE STATE WHEN WORN eoeoceoeoceoceo e9090900000000 OOODDDDD0000 Transmit Connected Error Disabled Tem OOOOO00000000 OOOOOOOOOOOO OOOOOOOOOOOO d Enabled Error Disabled Battery GOO90000900000 000000000000 XOOOOOOOOOOO00 3096 charge 30 charge 10 charge HR Detect eoeoeoeoeoeo eeco000000000 OCOOOOOOOOOOO HR Locked Strap worn HR not locked Not worn DEVICE STATE IN CRADLE Transmit eoeoeoceoceoeo eo00000000000 OOOOOOOOOOOO Connected Error Disabled Logging OOOOOOOOO0O000 OOOOOOOOOOO0O0 OOOOOOOOOOOO Downloading Error No records Finished Battery GO0000000000 000000000000 OOOOOOOOOOOO Charging Charged No power HR Detect QOOOOOOOOOOO Always off Page 33 of 46 Ph 1
22. atus Orange Status Orange No Alert for5 seconds Status Green A No Alert State for 5 seconds will reduce State from Red to Orange or Orange to Green 5 SEC ALERT STATE 55 SEC ALERT STATE n cdd TTT Oe GREEN ORANGE Oe cd 5 SEC NO ALERT STATE 5 SEC NO ALERT STATE The time intervals shown above are also configurable The values indicated are the default values Green 5 seconds Alert Orange gt Green to Orange Time Orange 55 seconds Alert Red gt Orange to Red Time 3 4 6 ROG Threshold Default Values Subject ROG thresholds can be configured and stored inside the device so that it can transmit an indication of ROG status as determined by the logic in the previous sections Information on configuring the device ROG thresholds is described for developers in 1 General Comms Link Specification Page 28 of 46 Ph 1 443 569 3603 Fax 1 443 926 9402 Web www zephyanywhere com 9700 0079 Zephyr Technology 2012 2012 09 12 technology BioHarness3 0 User Manual 3 5 Confirm Subject State Before fitting the chest strap to the subject confirm the following e Subject is not fitted with a heart pacemaker or automatic defibrillator e Subject has no pre existing skin irritation or trauma on the area where the strap will be located e Subject has not applied any lotion cream or oil to the skin area where the ECG sensors will be located HR Sensor locations Breathing Sensor location
23. battery should retain 8096 of new capacity after 300 charge cycles BATTERY MAINTENANCE TIPS e Store the device at 20 25 C to prolong battery life e Avoid storing in an uncharged state for prolonged periods e Atop up charge of the battery is recommended once a month if the device is not used regularly to maintain optimum battery condition Page 37 of 46 Ph 1 443 569 3603 Fax 1 443 926 9402 Web www zephyanywhere com 9700 0079 Zephyr Technology 2012 2012 09 12 Zephyr technology gBioHaress 3 0 User Manual 5 2 BioHarness Strap WASH INSTRUCTIONS O O O Detach the BioHarness module Rinse strap in fresh water after use to prevent salt buildup from perspiration Hand Wash or Machine wash on a Cold Delicate setting after 30 days of use Firmly attach the Velcro fastenings together and do not wash with other garments which may be damaged by these fastenings Use a washing pouch if possible Use soap or mild detergent but NOT sterilizing tablets Maximum recommended wash temperature 40 C 104 F Do Not spin or tumble dry Hang to dry out of direct sunlight Do not bleach Do not iron e Zephyr guarantees performance for a minimum of 80 machine washes of the chest strap Page 38 of 46 Ph 1 443 569 3603 Fax 1 443 926 9402 Web www zephyanywhere com 9700 0079 Zephyr Technology 2012 2012 09 12 Zephyr technology BioHarness 3
24. ch interference is suspected or experienced interfering systems should be removed from the vicinity Specific interference effects not resolved by this approach should be reported to Zephyr Technology Guidance and Manufacturer s Declaration Electromagnetic Emissions The BioHarness Bluetooth is intended for use in the electromagnetic environment specified below Electromagnetic Environment Guidance Test HF Emissions Class B The BioHarness Bluetooth is suitable for use in all establishments including CISPH 11 domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes A Bluetooth receiving device which captures data transmitted by the BioHarness 3 0 should not be located adjacent to or on top of any electrical or medical equipment which may cause interference to data transmission or reception Not intended for use on infants weighing less than 22lbs 10kg Page 7 of 46 Ph 1 443 569 3603 Fax 1 443 926 9402 Web www zephyanywhere com 9700 0079 Zephyr Technology 2012 2012 09 12 technology Biotarness 3 0 User Manual Manufacturer s Declaration Electromagnetic Immunit EMISSIONS Test Test Method Result Compliant Measured SE E Power Input Output ETSI EN 301 489 1 Section 8 4 EN 55022 2006 emissions were below applicable limits Compliant Measured Vibo ii Emissions AC ETSI EN 301 489 1 Section 8 5
25. ction parameters Displays and configures data transmit and or logging mode Sets device internal clock date and time 2 4 3 BioHarness Log Downloader This utility can be used to import log data which has been recorded on the BioHarness Module s internal memory when logging mode has been enabled This Application generates external csv files and or hed dat data files which can be interpreted using third party data analysis software Page 20 of 46 Ph 1 443 569 3603 Fax 1 443 926 9402 Web www zephyanywhere com 9700 0079 Zephyr Technology 2012 2012 09 12 Zephyr technology 9 BioHaress 3 0 User Manual 3 Operation 3 1 Overview The following tasks should be checked off before fitting the device to a subject Check the device internal battery is sufficiently charged Visually inspect BioHarness Module amp chest strap for signs of damage or wear Configure the device to transmit log mode or both Confirm that the subject ROG thresholds stored internally in the device are correct for the wearer Confirm the subject is not fitted with a heart pacemaker or defibrillator Confirm the chest strap is the correct size for comfortable fitting on the subject Actual Operation of the device consists of the following steps e Fit the device to the chest strap e Moisten the heart rate sensor pads with water to improve skin conductivity e Fit the chest strap and optional shoulders straps if used
26. dentified when scanned for Default is device serial number 3 Bluetooth detectable the device can be set to be non detectable if necessary Default is detectable 4 Link Timeout and Lifesign period settings Defaults are shown for use with Zephyr OmniSense software When both are set to no lifesign message need be sent and the device will never unilaterally time out the Bluetooth link 5 Other Bluetooth Devices to Call settings are for configuring the BioHarness to connect to auxiliary Bluetooth sensor for use in Zephyr PSM monitoring systems These will be set automatically for use when the device is used as a component of one of these systems Page 25 of 46 Ph 1 443 569 3603 Fax 1 443 926 9402 Web www zephyanywhere com 9700 0079 Zephyr Technology 2012 2012 09 12 technology 9 BioHarness 3 0 User Manual 3 4 3 802 15 4 ECHO ECHO is Zephyr s proprietary name for systems which are based on the 802 15 4 protocol 1 The Bluetooth tab in the Zephyr Cfg Tool allows the following to be configured Accelerometer Short Transceiver Address 59 RF Channel DA RF Power Level dB 19 Max Repeats 1 Beacon Interval ms 2400 Max Repeaters 4 Update ECHO Configuration system Factory configured Must be unique within a system 0 254 2 405 GHz 2 410 GHz Increment by 1 up to 25 Increment by 5 MHz 2 475 GHz 3 HF Power Level Factory configured at 19dB 4
27. evice Weight Strap Large Transmitter recorder Case Material Polycarbonate All dimensions in inches Page 45 of 46 Ph 1 443 569 3603 Fax 1 443 926 9402 Web www zephyanywhere com 9700 0079 Zephyr Technology 2012 2012 09 12 Zephyr technology BioHarness 3 0 User Manual BLANK PAGE Page 46 of 46 Ph 1 443 569 3603 Fax 1 443 926 9402 Web www zephyanywhere com 9700 0079 Zephyr Technology 2012 2012 09 12
28. gy BioHarness 3 0 User Manual 7 4 Compliance The BioHarness has been designed to conform to the following EC38 Type Type 3 RTTE Directive 1999 5 EC FCC ID VZ6 BH3 IC ID 7565B BH3 Contains Transmitter Module FCC ID T7V1315 IC ID 216Q 1315 X O C FCC Declaration NOTE THE MANUFACTURER IS NOT RESPONSIBLE FOR ANY RADIO OR TV INTERFERENCE CAUSED BY UNAUTHORIZED MODIFICATIONS TO THIS EQUIPMENT SUCH MODIFICATIONS COULD VOID THE USER S AUTHORITY TO OPERATE THE EQUIPMENT 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 Any computer used in conjunction with this device must be covered by a Declaration of Conformity or must be FCC certified in its own right 7 5 Environmental Operating Temperature 30 C 60 C Storage Temperature 40 C 85 C Charging Temperature 0 C 45 C ESD IEC 801 2KV IP Rating IP55 Page 44 of 46 Ph 1 443 569 3603 Fax 1 443 926 9402 Web www zephyanywhere com 9700 0079 Zephyr Technology 2012 2012 09 12 Zephyr technology mBioHaress 3 0 User Manual 7 6 Mechanical Dimensions Transmitter recorder 28 Diam x 7 mm 1 84 x 0 44 inches Charging Cradle 80w x 24d x 37h mm 2 5 x 1 6 x 1 1 inches Single d
29. ife Logging Z o 3 J 35 hs Charging Time ll 3 4 hs ee ERE el charges Charging Cycles A IL 30 J 1 Odes Digital resolution J 0 0 1 2 J LI bis Heart Rate ECG sensor sampling frequency 1 250 Ir Hz Rage DI 25 X 4 240 1 DEN Time tofirstlock At60b pm 15 25 s No Signal Response time 1 j60to0Obpm 10 s Input dynamic range ll 031 S 10 mV ECGAmplitude 6 025 15 mV Operating Modes Active device transmitting data logging if configured Standby device not transmitting but connectable logging if configured Notes 1 General Logging Gen ECG 140hrs Gen Acceleration 280hrs 2 Min Period after 180 charge cycles Max Period new battery 3 Software required for data download 4 After 300 deep discharge charge cycles the battery will retain a minimum of 80 of its original capacity Page 40 of 46 Ph 1 443 569 3603 Fax 1 443 926 9402 Web www zephyanywhere com 9700 0079 Zephyr Technology 2012 2012 09 12 Zephyr technology sBioHarness 3 0 User Manual 5 Heart Rate Accuracy for defined activity levels based on USARIEM guidelines Accuracy bpm Activity Level VMU oftime Max Deviation bpm KE EUM emulator ft L 4
30. ing of electrical goods Zephyr advises following local guidelines for conscientious disposal of equipment Zephyr Technology will undertake to dispose of any end of life components which are returned to their facility Zephyr Technology is registered in Europe under the WEEE recycling scheme Do not dispose of the device by fire Page 8 of 46 Ph 1 443 569 3603 Fax 1 443 926 9402 Web www zephyanywhere com 9700 0079 Zephyr Technology 2012 2012 09 12 Zephyr technology BioHaress 3 0 User Manual 1 3 Intended Use STATEMENT OF INTENDED USE The BioHarness 3 0 is a physiological monitoring telemetry device intended for monitoring of adults in the home workplace and alternate care settings The device consists of a chest strap and an electronics module that attaches to the strap The device stores and transmits vital sign data including ECG heart rate respiration rate body orientation and activity The BioHarness 3 0 provides a facility to detect and transmit single lead ECG signals to be received by Bluetooth USB qualified ECG instruments The BioHarness 3 0 collects and transmits measurements captured during both sedentary as well as rigorous activity for Heart Rate Posture and Activity Breathing rate values are accurately transmitted only during sedentary periods The BioHarness 3 0 is indicated for use as a general patient monitor to provide physiological information as part of an
31. le in this mode The LED on the front of the device illuminates flashing orange when in configuration mode O O O X All of these parameters are described in detail in the BioHarness BT Comms Link Specification 1 and BioHarness Bluetooth API Guide 4 documents Page 14 of 46 Ph 1 443 569 3603 Fax 1 443 926 9402 Web www zephyanywhere com 9700 0079 Zephyr Technology 2012 2012 09 12 Zephyr technology 2 3 System Components 2 3 1 BioHarness Module BioHarness 3 0 User Manual Blue Bluetooth indicator LED Orange battery indicator LED Hed HR detection status LED Green logging indicator LED ON OFF button wc REAR LABEL DETAIL 6 7 8 9 1 0 Ground spring contact Rear label location ECG signal spring contact USB charging configuration contacts Breathing signal spring contact ZEPHYR M N BIOHARNESS 3 FCC ID VZ6 BH3 IC ID 7565B BH3 Contains transmitter modules FCC ID T7V1315 E ZTAT CEFE IC ID 216Q 1315 AECG EC38 Type 3 Serial BH TA Powered by ZEPHYR Ph 1 443 569 3603 9700 0079 Page 15 of 46 Fax 1 443 926 9402 Zephyr Technology 2012 Web www zephyanywhere com 2012 09 12 Zephyr technology BioHarness 3 0 User Manual 2 3 2 BioHarness Chest Strap 1 Main fastener sleeve 7 Main fastener hook 2 Wash size and serial label 8 Internal breathing sensor location 3 Loop for optional shoulder strap 9 Conductive ECG sensor pad 4 Zephyr bra
32. module Indicates Declaration of Conformity to European health safety and environmental regulations Page 10 of 46 Ph 1 443 569 3603 Fax 1 443 926 9402 Web www zephyanywhere com 9700 0079 Zephyr Technology 2012 2012 09 12 technology BioHamess 3 0 User Manual 2 Technical Description 2 1 Model Identification The information in this document refers to Name Zephyr BioHarness 3 Model 9800 0189 Firmware Version 1 3 12 0 ZEPHYR M N BIOHARNESS 3 FCC ID VZ6 BH3 4 IC ID 7565B BH3 Contains transmitter modules FCC ID T7V1315 IC ID 216Q 1315 E Z747 AECG EC38 Type 3 Serial BH TAH C c FC Powered by ZEPHYR The Model number is marked on the identifying label on the rear of the device Firmware and hardware versions can be identified using the Zephyr Configuration Tool included in the BioHarness Software Developer s Kit E Zephyr Config Tool v1 0 7 0 IAN X Device Selection Bluetooth Poling Setup ROG Settings Subject Info User Config Time D Network ID BHT001026 Set Net Id Bluetooth detectable BHT001026 USB v Refresh Device List Read Only Data Link Settings Lis Boot Software Version Link Timeout ms 60000 Lifesign Period ms 3000 es defteg Bluetooth Devices to Cal Message NAK iWRAP Firmware Version MAC Address PIN Code BHT001026 Serial Number BioHamess Message NAK 9800 0153v3a Hardware Part Number BT Access Point 1
33. nd label 10 Conductive ECG sensor pad 5 BioHarness module receptacle and sensor contacts 6 Size adjustment slider buckle Page 16 of 46 Ph 1 443 569 3603 Fax 1 443 926 9402 Web www zephyanywhere com 9700 0079 Zephyr Technology 2012 2012 09 12 technology 9 BioHarness3 User Manual STRAP WASH LABEL DETAIL BioHarness Serial ZeFBH001019 SZ Tle ca 3019 Ensure velcro is fastened before washing Warm or cold wash iiis Size Medium and hang dry Do not tumble dry Yew RS STRAP SIZES Size To fit cm To fit Inches ZEN Small XS M 69 84 27 33 9600 0262 Large M XL 84 104 33 41 9600 0265 XLarge L XXL Up to 129 Up to 51 SHOULDER STRAP SIZE Size To fit cm To fit Inches ZEN Shoulder strap adjustable adjustable 9600 0117 Page 17 of 46 Ph 1 443 569 3603 Fax 1 443 926 9402 Web www zephyanywhere com 9700 0079 Zephyr Technology 2012 2012 09 12 Zephyr technology BioHarness 3 0 User Manual 2 3 3 BioHarness Charging and Configuration Cradle 1 USB Mini B socket 5V 2A input 2 USB Charge amp Configuration pins 2 3 4 BioHarness Charge Configuration Lead The charging configuring lead is a standard USB A plug to USB mini plug Zephyr Part No 0015 0003 Page 18 of 46 Ph 1 443 569 3603 Fax 1 443 926 9402 Web www zephyanywhere com 9700 0079 Zephyr Technology 2012 2
34. occupational welfare monitoring system for general research and performance measurement purposes or where prescribed by a healthcare professional T The device should not be connected to any external component other than the chest strap while it is being worn by the subject Page 9 of 46 Ph 1 443 569 3603 Fax 1 443 926 9402 Web www zephyanywhere com 9700 0079 Zephyr Technology 2012 2012 09 12 Zephyr technology mBioHaress 3 0 User Manual 1 4 Contraindications The device should not be worn by any subject with prior evidence of skin irritation at any point where the chest strap will contact the subject If a subject develops irritation or discomfort while the chest strap is being worn then use should be discontinued Users who have a surgically fitted heart pacemaker or automatic defibrillator should not use a BioHarness Not intended for use on infants weighing less than 22lbs 10kg 1 5 Table of Symbols Shall include explanation of all symbols marked on the device Rear label of BioHarness Module Indicates WEEE compliance all end of life BioHarness Modules should be returned to agent or distributor or recognised local channel for disposal Rear label of BioHarness Module Indicates C tick compliance for ECM standards for Australia and New Zealand Rear label of BioHarness Module Indicates FCC Part 15 compliance for radio emission regulation Rear label of BioHarness
35. ser documents Integrators must assume responsibility for documentation and software which is supplied to end users and operators of the physiological monitoring solution which incorporates the BioHarness Bluetooth system Integrators who incorporate the BioHarness Bluetooth into a proprietary physiological monitoring system assume responsibility for the validation and regulatory compliance of that system Page 6 of 46 Ph 1 443 569 3603 Fax 1 443 926 9402 Web www zephyanywhere com 9700 0079 Zephyr Technology 2012 2012 09 12 Zephyr technology BioHaress 3 0 User Manual 1 2 Warning and Safety Notices A The P symbol shown left indicates a warning Failure to heed the text included beside this symbol may compromise safe operation of the device The BioHarness is not specified for the following uses e As defibrillation proof For use in an oxygen rich environment As life supporting For use only in a shielded location For use with heart pacemakers For use with electrosurgical equipment T No modification of the BioHarness Module or chest strap is allowed ELECTROMAGNETIC COMPATIBILITY This device has been designed and tested to comply to the relevant electrical and electromagnetic interference standards for the countries it is available in This cannot completely eliminate the risk of interference with or from other radio transmitting or medical electrical equipment in close proximity If su
36. te that a subject parameter is outside an acceptable range of values Interpretation of such indication should be informed by one or more of the following e Knowledge of the subject s underlying physiological condition e g level of fitness abnormal blood pressure etc e Pre existing medical or physiological conditions e g fatigue dehydration infection trauma e Environmental Factors such as heat humidity etc or mechanical or motion factors which may affect activity data e Subject level of activity and any other circumstance which may lead to stress or fatigue such as fear lack of sleep etc Departure of heart rate breathing rate or activity level from an acceptable range of values may or may not cause the subject s Red Orange Green Status indication to alter This will depend on the values which have been assigned to the subject s ROG thresholds stored in the device These values may be occupational or activity dependent In addition the following factors may affect individual physiological parameter readings 4 1 Heart Rate Possible Cause Low Heart Rate Excessive noise caused by sensor skin relative movement and or poor conductivity between the skin surface and the sensor Adjustment of the chest strap tension for the correct fit and moistening of the sensor surfaces with water will address this issue in most cases High Heart Rate 4 2 Breathing Rate Possible Cause Low Breathing Rate Incorrect tension on
37. the chest strap may prevent adequate sensor response to chest expansion and contraction If the strap is too loose it may not respond the chest expansion if too tight it may not respond to chest contraction Individual subject breathing characteristics which are predominantly diaphragmatic as opposed to apical breathing High Breathing Rate Direct palpitation of the breathing sensor location from an external source which mimics the cyclical breathing action This may be due to the regular movement of any object which can apply direct external pressure to the sensor such as equipment components or webbing Page 35 of 46 Ph 1 443 569 3603 Fax 1 443 926 9402 Web www zephyanywhere com 9700 0079 Zephyr Technology 2012 2012 09 12 Zephyr technology 4 3 Skin Temperature Possible Cause A skin temperature channel in the general transmitted packet and log format exists in order to maintain reverse compatibility with earlier versions of Zephyr Minus 3276 8 C 4 4 Activity Level BioHarness 3 0 User Manual application software However the BioHarness 3 0 always returns an Invalid value of 3276 8 C for this parameter The BioHarness 3 does not support the okin Temperature channel Possible Cause Erroneous high activity level Internal accelerometers measure absolute movement of the device If a subject is inactive but in an environment which exerts forces on the device e g almost any mode of transport
38. tivity level values calculated over a 5 second rolling average Activity level is measured by an accelerometer within the BioHarness Device Parameters are determined to be LOW or HIGH according to the following thresholds IMACTIVE STATE ACTIVE STATE IMACTIVE STATE ACTIVE STATE HR Max HR Max F f D f D l A T i f D f A f Heart Rate Breathing Rate If any of the subject s parameter s above cross from the NORMAL Green zone to LOW or HIGH values Orange amber or Red then the subject s state may be raised from Normal to Alert according to the logic table following The default numerical values for the thresholds are set automatically and need not be changed for normal operation Page 27 of 46 Ph 1 443 569 3603 Fax 1 443 926 9402 Web www zephyanywhere com 9700 0079 Zephyr Technology 2012 2012 09 12 technology BioHarness 3 0 User Manual Any other states are Normal Each line in the table represents one permutation of parameters which generate an Alert state ROG Alert Logic Table Heart Rate Breathing Rate Activity Level NORMAL NORMAL NORMAL OW J 4 Aet NN LOW pert J HIGH pu NOT HIGH HIGH NOT HIGH The following logic is then applied Status Green Alert for 5 seconds Status Orange Status Orange Alert for 55 seconds otatus Red otatus Red No Alert for5 seconds St
39. ule to Gtranp 30 SN Mot lO OD E e EE 31 3 8 Power On Off BioHarness Module nannnnaannnnannnnnannnnannnnnnnnenannronnrrnnnnrronnrrennnrrrnnrrennrrrrenrrennnrronnrrennnrronnerene 32 3 8 1 Data Stabilisation TIMES wciccs sccescccssseracccsideaccescenidesescecaewaveracetsebescctdaanedetesdeacceetebacarted diei 32 9382 Device LED EE E Le DI Tm 33 Ss an a O a a a E e E i a ea 34 3 10 Esaa oND ite E E A EE E m 34 As INTERPRETATION OF deet 35 e RN En AE 35 4 2 Breathing Rate MEM 35 AsO ln BR ne D 36 4 4 Activity Level isiissiiiiisiitsinisniniiisinininiaisiniiiaiaindaiiadniiiniaiaiataid aiaia iadaiade dadaa aiadi iaidd naiha isinde iiinis ikaaindnsiiaiiinaiiaidi 36 5 MAINTENANCE eeh VT E 37 5 1 BioHarness Module E 37 5 1 1 Battery Lifetime and Replacement cccccecccccseeececeeeeeeeeeeeeeceeeeeeesaaeeesseaseeeseaueeesseeeeessenseseeeaes 37 B2 BIOBSImess ge a an ee utirstan Mic opu Renten M pet Ee rtani i PER EE 38 6 ACCESSORIES AND REPLACEMENT COMPONENTS sess na nnn nnn nnns nnn 39 to TECHNICAL SPECIFICATIONS E 40 Page 3 of 46 Ph 1 443 569 3603 Fax 1 443 926 9402 Web www zephyanywhere com 9700 0079 Zephyr Technology 2012 2012 09 12 Zephyr technology BioHarness 3 0 User Manual AM eds e TEER 40 7 2 General amp PNY SIOIOGICA ERNEUT 40 PON VMMT M 43
40. y the BioHarness module is powered only by an internal rechargeable lithium polymer cell e he BioHarness Module is secured in a receptacle attached to the chest strap and worn by the subject as shown shoulder straps are optional for additional security and do not affect the performance of the chest strap It is powered on and off by depressing the front of the device A series of flashing LEDs on the front of the device indicates its status It is powered by an internal battery Passive sensors in the strap detect heart ECG signals through conductive pads A pressure sensor pad in the strap on the subject s left hand side detects expansion of the rib cage due to breathing action A thermistor measures the device internal temperature e An internal 3 axis accelerometer in the BioHarness module measures subject activity level and orientation of the device subject standing supine prone inverted e All sensor data is processed within the BioHarness Module e An indication of subject physiological status Green Orange Red is calculated based on sensor input and subject threshold values stored within the device when it is configured e t sends physiological data wirelessly by Bluetooth or 802 15 4 to an appropriate receiving device with graphical interface e The device can transmit over Bluetooth and 802 15 4 frequencies simultaneously Page 12 of 46 Ph 1 443 569 3603 Fax 1 443 926 9402 Web www zephyanywhere com 9700 0079
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