Hidalgo EQ001 User Guide
EQUIVITAL™ EQ-01 VITAL SIGNS
MONITOR
HEALTH CARE PRACTIONER GUIDE
Draft: A Date: 28th April 2006
For Support or further information on this product contact:
Customer Support
Hidalgo Limited
Stable Block at The Grange
20 Market Street
Cambridge
CB4 5QG
United Kingdom
www.hidalgo.co.uk
Tel: +441954 233430
email: equivitalsupport@hidalgo.co.uk
Stable Block at The Grange, 20 Market Street, Swavesey, Cambridge, CB4 5QG
Tel: +44 (0) 1954 233430 Fax: +44 (0) 1954 233431
www.hidalgo.co.uk
HEALTH CARE PRACTIONER GUIDE
CONTENTS
Equivital Monitor Intended Use: ................................................................................................................ 6
Contraindications ................................................................................................................................... 7
Technical Description :............................................................................................................................... 8
System Overview..................................................................................................................................... 8
System Components ................................................................................................................................ 10
Hardware: .............................................................................................................................................. 10
Chest Belt ........................................................................................................................................... 10
The Sensor Electronics Module “SEM” .............................................................................................11
Battery Charger ................................................................................................................................. 12
Software : ............................................................................................................................................... 12
SEM Customisation Utility .................................................................................................................. 12
SEM Viewer ......................................................................................................................................... 13
System Integration Kit........................................................................................................................ 13
Sensor Overview ....................................................................................................................................... 14
Block Diagram ....................................................................................................................................... 14
ECG and Heart Rate Derivation.......................................................................................................... 15
Breathing Frequency ............................................................................................................................ 17
Skin Temperature ............................................................................................................................... 18
Body Position and Motion................................................................................................................. 19
Indications and Alerts............................................................................................................................... 20
ECG Indications..................................................................................................................................... 20
Respiration Effort Indications ............................................................................................................... 20
Combined Indication ....................................................................................................................... 21
Threshold Exception Condition: ....................................................................................................... 23
Single Alarm Exception Condition:.................................................................................................. 23
Multiple Alarm Exception Condition ............................................................................................... 24
Sensor Error Condition: ...................................................................................................................... 24
Sensor Self Check Okay:................................................................................................................... 25
Exception Cleared Condition: ......................................................................................................... 25
Confidence Derivation : ................................................................................................................... 26
VSDS Confidence Rate..................................................................................................................... 27
Secondary Confirmation: ................................................................................................................. 27
Connecting and Using the Sensor – Model Number EQ01-002/012 (Type 0 Low Power PAN
Interface) 29
Sensor Activation .................................................................................................................................. 29
Sensor Range......................................................................................................................................... 29
Protocol Overview ................................................................................................................................ 29
Sensor Diagnostics ................................................................................................................................ 30
Connecting to and Using the Sensor– Model Number EQ01-001....................................................... 31
(Type 1 Bluetooth™) ................................................................................................................................ 31
Bluetooth™ Connection Information ............................................................................................... 31
Sensor Data Security............................................................................................................................. 31
Application Protocol Overview ........................................................................................................... 31
Summary Disclosure .......................................................................................................................... 31
Full Disclosure ..................................................................................................................................... 32
Sensor Configuration Data ...................................................................................................................... 34
Indication Rate Limits and Time Thresholds........................................................................................ 34
Power On Defaults ............................................................................................................................ 36
Bluetooth Link Parameter ................................................................................................................. 37
Belt Construction....................................................................................................................................... 38
Accessories................................................................................................................................................ 39
Repair and Service ................................................................................................................................... 39
Technical Specifications .......................................................................................................................... 39
FCC Compliance and Advisory Notice (US Markets) .......................................................................... 42
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HEALTH CARE PRACTIONER GUIDE
Explanation of Symbols
Within this manual the following symbols are used to indicate warnings and precautions a user or
operator should take when using this device:
A warning is shown within a highlighted box and includes a symbol
Failure to follow the warning may comprise the safe operation of the device and can lead to a
risk of injury.
A precaution is noted in a highlighted text. Failure to follow a precaution may lead to a
reduction in performance of the device when in use.
Purpose of this guide
This guide is intended for use by trained Health Care Practitioners using the Equivital™
physiological monitoring device to monitor individuals vitals signs and who are familiar with
cardio respiratory monitoring terminology and practise.
It also provides information for system integrators who wish to use Equivital™ as element of a
broader healthcare monitoring system.
A separate user guide is available for use by patients and users of the device. Consult this
manual to find information on:
Warnings and Cautions a user/patient should know before wearing the device
•
How to fit the device to the body
•
• How to switch on the device
• How to change batteries and recharge the device
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HEALTH CARE PRACTIONER GUIDE
Before using Equivital™
Please observe the following warnings and precautions:
Warnings
• THE EQUIVITAL™ DEVICE MAY BE USED TO MONITOR INDIVIDUALS IN THE
WORKPLACE. WHEN USED IN THIS MANNER THE DEVICE MUST BE INTEGRATED INTO
THE OPERATING ORGANISATIONS SAFETY AND RISK MANAGEMENT PROCEDURES.
USERS SHOULD RECEIVE APPROPRIATE TRAINING FROM YOUR ORGANISATION
BEFORE USING THIS DEVICE
USE OF THE DEVICE DOES NOT JUSTIFY THE USER OR ORGANISATION TO TAKE
•
ADDITIONAL SAFETY RISKS OR TO REDUCE LEVEL OF CARE.
• THIS DEVICE DOES NOT AUTOMATICALLY CALL EMERGENCY SERVICE ASSISTANCE.
• THE DEPLOYING ORGANISATION IS RESPONSIBLE TO ENSURE THAT THESE WARNINGS
ARE UNDERSTOOD AND FOLLOWED.
• THE EQUIVITAL DEVICE SHOULD NOT BE USED FOR SURGICAL PROCEDURES, TO
PERFORM SYNCRONISED CARDIOVERSION OR INTRACARDIAC MONITORING, OR
WHEN PERFORMING EXTERNAL PACING.
• THE DEVICE SHOULD NOT BE APPLIED TO USERS WHO HAVE EXISTING SIGNS OF SKIN
IRRITATION AND DAMAGE AT THE SITES THE DEVICE IS LOCATED ON.
• USERS WHO EXPERIENCE IRRITATION AND RASHING SHOULD BE ADVISED TO
DISCONTINUE USE IMMEDIATELY.
THE DEVICE SHOULD NOT BE USED ON PATIENTS WITH IMPLANTED DEFIBRILLATORS
•
OR PACEMAKERS.
DO NOT ATTEMPT TO CONNECT ANY CABLES TO THE EQUIVITAL DEVICE WHEN
•
WORN ON BODY- THIS INCLUDES HIDALGO SUPPLIED BATTERY CHARGING DEVICE.
ALWAYS REMOVE THE DEVICE BEFORE CHARGING.
• USE ONLY THE HIDALGO PROVIDED BATTERY CHARGER AND BELT ASSEMBLIES WITH
THE DEVICE. THE SAFE USE OF THE DEVICE IS ONLY GUARANTEED WITH THESE
ACCESSORIES. A FULL LIST OF ACCESSORIES IS PROVIDED AT THE REAR OF THIS
DOCUMENT
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HEALTH CARE PRACTIONER GUIDE
Precautions
ADVISE THE USER NOT TO USE LOTIONS, OILS, PERFUMES, DEODORANT OR POWDER ON THE AREA
•
WHERE THE SENSOR BELT IS BEING APPLIED
• EACH TIME YOU ISSUE THE SENSOR INSPECT THE BELT AND CASE UNIT FOR SIGNS OF DAMAGE (TEARS/
CRACKS ETC). IF ANY DAMAGE IS IDENTIFIED DO NOT USE THE SENSOR UNTIL THE DAMAGED PART
HAS BEEN REPLACED
TO GET MAXIMUM PERFORMANCE FROM THE SYSTEM YOU SHOULD REPLACE THE BELT HARNESS AFTER
•
25 WASHES.
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HEALTH CARE PRACTIONER GUIDE
Equivital Monitor Intended Use:
The Equivital™ Vital Signs Physiological Monitor is a non-invasive ambulatory wireless
telemetry device intended to allow monitoring of a users vital signs physiology in
environment’s where access to traditional clinical care facilities may be limited or
impractical (for example in the workplace or outdoors) and justification exists for such
monitoring.
The device maybe used by persons operating in circumstances where an increased risk of
physical trauma exists due to the environment in which the user is placed. Typically, these
environments may be found within personnel working in the military, public safety and
hazardous plant workplaces.
The device may also be used as a general cardio respiratory monitor, in particular, where
the compact and ambulatory characteristics of the device are advantageous. In
addition, the device may also be used for the collection of ambulatory physiology for
general research purposes in application such as sports or human performance medicine
and research.
The device offers continuous monitoring of two views of the user’s heart electrical activity
(ECG) and respiratory breathing frequency inferred from thoracic cavity movement and
uses this data to derive a Heart and Breathing Effort Rate.
The sensor also provides additional information:
• Physiological waveforms.
an indication of the users activity level (none, low or high) derived from a
•
movement detection sensor.
body orientation.
•
• chest skin surface temperature.
• alternate secondary measurement of heart rate based on the detection of the
users R wave using a separate hardware processing function.
• alternate secondary measurement of respiration effort using thoracic impedance
pneumography.
• indications and alerts if physiology exceeds predefined boundaries.
The wireless data provided by the sensor may be viewed using a standalone PC based
viewing application, or integrated into a broader care monitoring application. In the later
application the system integrator is responsible for the end to end performance of the
system and appropriate regulatory compliance.
It use within occupational welfare monitoring is intended as an addition to the deploying
organisations established risk assement and welfare management procedures. The device
is not intended to replace the need for such assessments to have occurred and
appropriate procedures to be put in place.
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HEALTH CARE PRACTIONER GUIDE
Contraindications
The device is not intended to replace the need for appropriate medical supervision and
safe practise to be provided to users by an operating organisation.
The device is not intended for use by children less than 16 years or adults over 65 years.
The device is not intended for use as apnea monitor within a clinical context.
The device is not intended for surgical use or as part of life support systems within a clinical
context.
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HEALTH CARE PRACTIONER GUIDE
Technical Description :
System Overview
Personal
Area
Network
Telephone or
Mobile Data Wide
Area Network
Remote Monitoring Station
Figure 1 - Sensor Application Diagram
Figure 1 shows an application diagram for the Equivital sensor. The sensor is worn by a user and
records the user’s physiology in real time.
The Equivital sensor comprises of two main elements:
• A passive chest belt containing three conductive sensor electrodes and a expansion
strain gauge.
• A sensor electronics module (or “SEM”) which contains power, processing electronics
and a wireless transmitter.
The sensor transmits this data on its personal area network radio to a wireless receiving device.
The choice of radio technology used by the device is selectable at the point of manufacture
and currently the following options can be supplied:
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HEALTH CARE PRACTIONER GUIDE
• Type 0 radio interface – A low power packet radio interface designed for use in
applications within the United States Military.
Type 1 radio interface – Bluetooth™ Transceiver supporting the Bluetooth™ defined
•
Serial Port Profile (SPP).
The sensor can communicate with a wireless receiving device which may either record and
display the data locally (e.g. on a PC which contains an integral wireless transceiver) or may
relay the data over further wide area communications networks before it is displayed on a
remote monitoring station.
The wireless receiving device used is dependant on the type of radio interface ordered. For the
Type 0 interface, the sensor is designed to use a protocol suitable to send data to a US
Department of Defense developed receiver/data logger know as a Hub. The same interface is
also supported by the MiniMitter/Respironics Vitalsense monitor.
The Type 1 interface is designed to allow flexibility in choice of receiving device and hence uses
the open communications standard Bluetooth™ to provide the data communications path.
Hence the device may be used with any Bluetooth™ compliant receiver.
The system is provided with a Window s based viewing application “Equivital Viewer” which
enables the data from a sensor to be displayed and recorded. It is expected that some
deploying organisations will wish to develop specific applications which integrate the sensor into
a larger scale monitoring system (eg: including location and mapping functions).
• ORGANISATIONS INTEGRATING THE EQUIVITAL SENSOR INTO LARGER SCALE
SYSTEM APPLICATIONS ARE RESPONSIBLE FOR ENSURING AND VALIDATING THE
SAFETY, EFFICACY AND REGULATORY COMPLIANCE OF THE RESULTING SYSTEM
A system integrators toolkit is available which provides information on the wireless protocol and
a test application to assist development of such applications.
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HEALTH CARE PRACTIONER GUIDE
System Components
Hardware:
The following sections provide an overview of each of the main elements needed to use the
Equivital sensor:
Chest Belt
The chest belt comprises a horizontal band which goes around the users chest beneath the
pectorals. Within this band three fabric based silver coated electrodes are located which
connect to the body in order to capture ECG signals and also measure thoracic cavity
impedance changes from the user. In addition a strain gauge is also contained to measure the
expansion of the thoracic cavity, associated with breathing effort.
Figure 2 - VSDS Chest Belt
The horizontal strap is tensioned by a belt adjuster provided at the rear of the belt. Details on
how to fit the belt correctly are provided in the Equivital User Application Guide.
A elasticated shoulder strap is provided which acts to minimise the belt slipping down the torso
during exercise.
The chest belt contains a center piece which sits beneath the sternum and provides five snap
connectors which are used to connect the electronics module (“SEM”) to the belt.
The chest belt is available in a variety of sizes to match differing users – See for details
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HEALTH CARE PRACTIONER GUIDE
The materials selection used to make the belt is provided in Section tbd.
The Sensor Electronics Module “SEM”
The Sensor Electronics Module “SEM” device contains all of the processing electronics , software
and communications circuits needed to operate the sensor.
The SEM may be ordered from the factory in two power supply variants;
• 2 x AAA/LR03 primary (non rechargeable) cells
• Rechargeable Li-ION battery
Figure 3 - Sensor Electronics Module Front and Rear
The rear of the SEM unit provides the mating connectors needed to attach the device to the
chest belt. In addition, a battery door is also provided to allow batteries to be changed.
On the front of the unit is an external interface connector which normally has a protective bung
connected.
External
Interface
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HEALTH CARE PRACTIONER GUIDE
This interface is used to:
• Recharge the Li-ION Cell
• Customise the SEM with specific information
• Perform system maintenance functions (by the factory)
NOTE THE DEVICE WILL NOT FUNCTION IF THE BUNG IS NOT FITTED
Battery Charger
The battery charger is a medically approved recharging device and needs to be connected to
the SEM to recharge the SEM.
The battery charger will charge a flat battery in 2.5 hours.
USE ONLY PRIMARY NON-RECHARGABLE (LR03 AAA) ALKALINE CELLS.
•
RECHARGEABLE AAA CELLS SHOULD NOT BE USED.
• DO NOT ATTEMPT TO CONNECT ANY CABLES TO THE EQUIVITAL DEVICE WHEN
WORN ON BODY- THIS INCLUDES HIDALGO SUPPLIED BATTERY CHARGING DEVICE.
ALWAYS REMOVE THE DEVICE BEFORE CHARGING.
• USE ONLY THE HIDALGO PROVIDED BATTERY CHARGER AND BELT ASSEMBLIES WITH
THE DEVICE. THE SAFE USE OF THE DEVICE IS ONLY GUARANTEED WITH THESE
ACCESSORIES. A FULL LIST OF ACCESSORIES IS PROVIDED AT THE REAR OF THIS
DOCUMENT
Software :
SEM Customisation Utility
This is a Windows based application which allows health care professional to configure certain
thresholds and features within the Sensor Electronics Module.
Minimum system and operating system requirements are provided with distribution discs
containing this application.
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HEALTH CARE PRACTIONER GUIDE
SEM Viewer
The SEM Viewer is a Windows application which allows a remote user to display
Heart Rate
•
• Heart Rate Indications
• Respiration Effort Rate
• Skin Temperature
• Body Position
• Motion
• Sensor information and diagnostics
Figure 4 - SEM Viewer Application
System Integration Kit
For system integrators a special development kit is available which includes protocol interfacing
information and test applications to ease integration and application development. Contact
Hidalgo for further details.
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