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MobileCare™ Monitor Operator’s Manual

Appendix C

— Declarations

See

http://www.iec.ch

for the FCC and IEC standards.

Refer to the following tables for specific information regardi

ng this device’s

compliance with IEC 60601-1-2.

Electromagnetic Emissions

EMISSIONS TEST

COMPLIANCE

ELECTROMAGNETIC ENVIRONMENT

—GUIDANCE

This device is intended for use in the electromagnetic environment specified below. The customer and/or user of this device

should ensure that it is used in such an environment.

RF Emissions CISPR 11

Harmonic Emissions
IEC 61000-3-2

Voltage Fluctuations/Flicker
Emissions IEC 61000-3-3

Electromagnetic Immunity

IMMUNITY TEST

IEC 60601 TEST LEVEL

COMPLIANCE

LEVEL

ELECTROMAGNETIC

ENVIRONMENT

—

GUIDANCE

This device is intended for use in the electromagnetic environment specified below. The customer and/or user of this device

should ensure that it is used in such an environment.

Electrostatic Discharge (ESD)
IEC 61000-4-2

Electrical Fast Transient/Burst
IEC 61000-4-4

Surge IEC 61000-4-5

Voltage dips, short interruptions,
and voltage variations on power
supply input lines IEC 61000-4-
11

Power Frequency (50/60 Hz)
Magnetic Field IEC 61000-4-8

NOTE:

is the AC mains voltage before application of the test level.

Guidance and Manufacturer’s Declaration—Electromagnetic Immunity

IMMUNITY

TEST

IEC 60601 TEST

LEVEL

COMPLIANCE

LEVEL

ELECTROMAGNETIC ENVIRONMENT

—GUIDANCE

This device is intended for use in the electromagnetic environment specified below.

The customer and/or user of this device should ensure that it is used in such an environment.

Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than
the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Conducted RF

Содержание MobileCare

Страница 1: ...MobileCare Monitor System Operator s Manual AFrame Digital Inc 8000 Lee Highway Falls Church VA 22042 703 560 0512 Email service aframedigital com www aframedigital com ...

Страница 2: ......

Страница 3: ...Using myPHD Buttons 11 3 1 4 Checking for Out of range Status 12 3 1 5 Verifying the Battery Charge 12 3 1 6 Sending Emergency Alerts to Caregivers 13 3 1 7 Temporarily Disabling Alerts 14 3 1 8 Impact Sensing and Falls 16 3 1 9 Canceling Alerts 16 3 1 10 Interpreting Error Messages 18 3 2 Using the Charger 18 3 3 Using the CareStation Software 20 3 3 1 Logging into the CareStation Application 20 ...

Страница 4: ...4 3 Server Security 33 5 0 TroubleShooting 34 5 1 Troubleshooting myPHD and Battery 34 5 2 Troubleshooting PANDA 34 Appendix A Warranty 35 Appendix B Service 36 Appendix C Declarations 37 Appendix D Specifications 39 myPHD Specifications 39 PANDA X4 Gateway Specifications 41 ...

Страница 5: ...Cautions Inspect the device at least every 6 to 8 hours to ensure correct device alignment and skin integrity Patient sensitivity to the device may vary due to medical status or skin condition Factors that may degrade the performance or affect the accuracy of the measurement include the following excessive light such as sunlight or direct home lighting excessive motion moisture in the device impro...

Страница 6: ...remove or attempt to change the batteries in any manner This is only to be performed by an AFrame Digital authorized representative Follow local state and national governing ordinances and recycling instructions regarding disposal or recycling of the device and device components including batteries In compliance with the European Directive on Waste Electrical and Electronic Equipment WEEE 2002 96 ...

Страница 7: ...ystem may be affected if used in a strong electromagnetic field environment Do not use the system if any component is damaged Caution the residents against causing impacts to myPHD Intended or unintended impact of myPHD may trigger alerts Do not immerse the MobileCare Monitor or its components in water or any other liquid Do not use caustic or abrasive cleaning agents for the MobileCare Monitor or...

Страница 8: ...em works How to use the myPHD wristwatch to send alerts How to use the CareStation software to respond to alerts Use the following table to quickly find information in this manual To find out about Go to How the MobileCare Monitor System works 2 0 System Overview How to use myPHD and the CareStation software 3 0 Operating Procedures How to solve problems with the functioning of myPHD and PANDA 4 0...

Страница 9: ...ething important or useful Conventions used in this manual The following conventions are used in this manual This type of text Is used for Bold Button names Italics Emphasis Assumptions We assume that the MobileCare Monitor System is already installed by a qualified representative of AFrame and is running on your facility s network This guide is intended for the operators of the MobileCare Monitor...

Страница 10: ... round the clock basis For monitoring purposes residents wear a specially designed watch that is part of the MobileCare Monitor System The system sends designated alerts see Figure 1 1 from these residents to administrators and healthcare providers or caregivers of multi resident care facilities These alerts are designed to elicit a quick response from the caregivers see Figure 1 2 In addition car...

Страница 11: ...patient assessment and care It must be used in conjunction with other methods of assessing the health and wellness in individuals and symptoms The system is not intended to provide automated treatment decision nor is it to be used as a substitute for professional healthcare judgment All patient medical diagnosis and treatment are to be performed under the direct supervision and oversight of an app...

Страница 12: ...ises Caregivers are provided impact detection alerts The user interface between a monitored individual and the MobileCare Monitor System is a wireless personal help device myPHD or watch that is worn on an individual s wrist This watch is a non intrusive and form friendly portable alerting device that transmits data wirelessly to a gateway and server via a wireless mesh network The MobileCare Moni...

Страница 13: ...the facility The system uses the ZigBee see What is ZigBee below mesh network to allow individuals to be mobile within the network Data is transmitted between the watch and the XBee units through a message based protocol over a ZigBee mesh network The data is transferred between the PANDA X4 gateway and the server through a secure HTTP protocol The caregivers receive alerts via a secure Internet b...

Страница 14: ...4 specifications The devices using ZigBee form a mesh network where each device connects wirelessly to the next ZigBee uses very little power therefore is ideal for small networks Figure 2 2 Interconnection and dataflow between several MobileCare Monitor components 2 2 Overview of myPHD The myPHD allows the residents to be mobile while being monitored by the network The myPHD periodically transmit...

Страница 15: ...reStation Software for a pre set interval of time Figure 2 3 The myPHD with buttons Furthermore the myPHD contains Built in temperature sensor provides resident skin body and ambient air temperatures to help determine if the watch is being worn Impact sensor issues an alert when the myPHD receives an impact such as when a resident falls Battery charge level indicator displays the remaining battery...

Страница 16: ...gateway and forwards the messages alerts to the relevant myPHD PANDA Powered Automated Network Data Aggregator X4 Gateway Gateway between the Internet and the internal wireless mesh network Connects to the Internet via Ethernet Wi Fi or Broadband Sends the received messages from the XBee routers to the secure server Communicates wirelessly with the myPHDs and the central server allowing total free...

Страница 17: ...rver so caregivers can view and analyze the resident s information Provides actionable clinical data as well as specific reports to improve health care management Assists health care staff in providing individual personalized care Table 2 1 MobileCare Monitor System Component and Features The operators should use only AFrame Digital specified sensors and third party devices AFrame cannot guarantee...

Страница 18: ...tibility Standard The MobileCare Monitor System complies with International Standard EN 60601 1 2 2004 for electromagnetic compatibility EMC for medical electrical equipment or systems or both This standard is designed to provide reasonable protection against harmful interference in a typical medical installation ...

Страница 19: ...d by the end user These components such as the routers the gateway and the server must be installed by the representatives of AFrame Digital Inc who are trained in the proper installation techniques 3 1 Using myPHD This section explains how to Wear myPHD and use the various options Check for out of range status Send emergency alerts using myPHD Analyze the messages displayed by myPHD The myPHD is ...

Страница 20: ...nts or caregivers Only an authorized representative of AFrame Digital Inc will service the batteries Batteries must be recharged after several days under normal use conditions 3 1 3 Using myPHD Buttons MyPHD has two buttons Emergency button and Privacy button Figure 3 1 The myPHD with buttons Table 3 1 summarizes the use of these buttons Press Result Emergency button Send an emergency alert to the...

Страница 21: ...strative staff The signal strength indicator on the myPHD display will indicate if the resident is within range of the XBee wall routers Additionally if the resident is within the range myPHD will display the date and time When the resident moves out of the range of XBee wall routers the signal strength indicator will change Additionally a WATCH FAILED message will flash on the myPHD s display pan...

Страница 22: ...ON all the time The server constantly monitors the status of all these components and will raise an alert in the event of any failure 3 1 6 Sending Emergency Alerts to Caregivers When the residents or patients need the assistance of a caregiver they can send an emergency alert using myPHD Before sending an emergency alert the residents should ensure that they are within the range of an XBee wirele...

Страница 23: ...HD 5 Finally the caregiver who attends to the call will reset the display back to normal status See the section 3 1 7 Resetting myPHD to Normal State for more information on resetting the display 3 1 7 Temporarily Disabling Alerts The myPHD alerting device sends resident data location information and alerts using a wireless network Sometimes the residents may choose not to send any data to the ser...

Страница 24: ...sident presses the Privacy button before the pre defined setting time has elapsed the privacy duration will be reset and the countdown will start afresh In this way the resident can extend the privacy duration if desired 3 After the pre defined number of minutes has elapsed the device will switch back to normal status and once again start transmitting location and clinical data Countdown indicatin...

Страница 25: ...and automatically sends an alert to the caregiver The myPHD alerting device XBee wall routers and the PANDA unit are designed to be powered ON all the time The server constantly monitors the status of all these components and will raise an alert in the event of any failure 3 1 9 Canceling Alerts If the residents send emergency alerts by mistake they can cancel the alert before it reaches the careg...

Страница 26: ... on the display panel press the Privacy button 2 The emergency alert will be canceled and the EM MSG CANCLD message will be displayed on the display panel 3 The myPHD device will then switch back to normal mode Pushing the emergency button or falling will generate an alert message overriding the privacy feature ...

Страница 27: ...on while out of the signal range of the MobileCare Monitor System The resident must move inside the signal range of the MobileCare Monitor System PRIVCY Displayed when the resident has activated the privacy mode on the myPHD device PRV nn Displayed when the myPHD device is in privacy mode and is not sending any resident data nn is the number of minutes of privacy remaining The myPHD device will no...

Страница 28: ...aph below indicates the status of charging Figure 3 2 1 The charger LEDs The LEDs on the charger provides three possible status scenarios as stated in the following Table Rapidly Flashing Red Failure Blinking Green Charger is charging the myPHD Solid Green Charging Complete When the myPHD is placed on the charger the myPHD display confirms this event as CHARGE ...

Страница 29: ...reStation Software is an easy to use web browser based secure application for helping caregivers and administrative staff to respond to myPHD alerts In addition the operators can use the software to View the location of a resident on the pre installed facility map View and analyze data collected from the residents View specific reports to help improve management of the facility 3 3 1 Logging into ...

Страница 30: ...or will be able to see the main screen Resident Status screen of the CareStation application 3 3 2 Understanding the Resident Status Interface The Resident Status screen see Figure 3 3 is the main screen that is displayed to the operators after they login to the CareStation application The Resident Status screen shows the status such as alerts or Activity of Daily Listings ADL of all the residents...

Страница 31: ...nt Status present at the top of the screen The following table summarizes the available options Click this link to view the location of the residents on the Facility Map Click any of these links or pictures to view the details of that resident Click this link to view the Alert Summary screen for all residents These links show the last known location of the resident Click any of these links to view...

Страница 32: ...y Map Facility Map link at the top of the screen Open the Facility Map screen Alert Summary link at the top of the screen Open the Alert Summary screen Table 3 3 The available options This resident status screen displays a green icon for residents whose alerts have been responded to 3 3 3 Understanding the Resident Detail Interface To view the details of a resident the operator will click the name...

Страница 33: ...24 Figure 3 4 Details of a particular resident 3 3 4 Understanding the Alert Summary for a Particular Resident To view the alert details of a particular resident see Figure 3 5 the operator can click the Alerts Summary icon of that resident from the Resident Status screen ...

Страница 34: ...cators which are based on the status of the resident alert The following are the various alarm indicators Acknowledged Needs Help False Alarm Escalated 3 3 5 Understanding the Alert Summary for All Residents To view the alert details of residents see Figure 3 6 the operator can click the Alerts Summary link displayed at the top of the Resident Status screen ...

Страница 35: ...p is always integrated with the CareStation software To locate the resident graphically within the facility the operator clicks the Facility Map link displayed at the top of the Resident Status screen This screen displays the last known location of each resident see Figure 3 7 On the facility map the image border is red if an alert is pending and green if alerts are not pending ...

Страница 36: ...alerts received from a resident the operator clicks the particular Alert from the Resident Status screen see Figure 3 8 a The list of alerts from the resident is displayed in the Alert Summary screen The operator then clicks the alert that needs attention see Figure 3 8 b and must be acknowledged see Figure 3 8 c Figure 3 8 Responding to an alert In this screen the operators can perform any of the...

Страница 37: ...configures the MobileCare Monitor System to send the alerts to the operator s cell phone PDA personal digital assistant or web enabled phone such as iPhone Cellular Phone On a cellular phone with text messaging capability only text messages will appear When a resident presses the emergency alert button the system generates and sends a text message such as the following message to the operator s ce...

Страница 38: ... the alarm by selecting the False Alarm option Escalate the alarm to the next person for instance supervisor or next in command up in the line to assist After the operator clicks Acknowledge the Alert Acknowledged message will be displayed on the CareStation screen and on the myPHD Figure 3 10 The Alert Acknowledged message The time taken to respond is displayed in the Alert Summary for individual...

Страница 39: ...Clearing the Alerts Operators can clear the alerts from the Alert Summary screen by clicking the Needs Help icon see Figure 3 6 When clicked a web page will be displayed that is similar to the web page displayed on the iPhone see Figure 3 9 from where they can respond to the alert ...

Страница 40: ...s from joining the ZigBee network each device is authenticated using a special link key that is preconfigured on every device When a device attempts to join the network the PANDA uses this link key to distribute a network key which in turn is used to encrypt and decrypt traffic If the device does not have the correct link key it will not be allowed to join the network The AFrame System protects ag...

Страница 41: ... SSL authenticated and secured connection such that they are protected against disclosure When caregivers access the CareStation application on the server the server authenticates the user with a unique username and password Passwords are required to meet complexity requirements to ensure that they cannot be guessed This username and password travels over the SSL authenticated and secured connecti...

Страница 42: ...ted via public key authenticated Secure Shell SSH access and all administrative traffic is protected using strong encryption To ensure that the server is not left vulnerable to attack strict configuration and security patch management procedures are followed As an additional measure AFrame periodically performs security scanning to validate its security posture To protect against internal threats ...

Страница 43: ...rking of myPHD ensure that Battery is properly charged Unit is functioning Alert is generated when the Nurse call button is pressed Light indicators are working 5 2 Troubleshooting PANDA For the proper working of PANDA ensure that Power cord is plugged correctly Network activity light of the Ethernet port is blinking Power is ON ZigBee activity light is ON For assistance call 703 560 0512 or email...

Страница 44: ...es cost of delivery to and from AFRAME All repaired units shall be received by the purchaser at AFRAME s place of business For any MobileCare Monitor 2100 sent to AFRAME for warranty repair that is found to be within specification the purchaser agrees to pay 100 00 US Dollars to defray costs of handling and testing The MobileCare Monitor 2100 is a precision electronic instrument and must be repair...

Страница 45: ...evidence of opening the system service by non AFrame personnel tampering or any kind of misuse or abuse of the system shall void the warranty in its entirety For additional technical information contact AFrame s Customer Support department at AFrame Digital Inc 8000 Lee Highway Falls Church VA 22042 703 560 0512 Email service aframedigital com www aframedigital com The standard rates and charges i...

Страница 46: ...vironment specified below The customer and or user of this device should ensure that it is used in such an environment Electrostatic Discharge ESD IEC 61000 4 2 Electrical Fast Transient Burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power Frequency 50 60 Hz Magnetic Field IEC 61000 4 8 NOTE UT is the AC ma...

Страница 47: ...n from structures objects and people Recommended Separation Distances The following table details the recommended separation distances between portable and mobile RF communications equipment and this device This device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled Users of this device can help prevent electromagnetic interference by maintain...

Страница 48: ...ply Current Standby Mode IDDsbm Digital and Analog 1 2 A Operating Temperature TA 40 85 C Acceleration Output Signal Acceleration Output Format 10 Bit Resolution 2 s complement Sensitivity S2g g range 2g 246 256 266 LSB g S4g g range 4g 122 128 134 LSB g S8g g range 8g 61 64 67 LSB g Zero g Offsett Off TA 25 calibrated 60 60 Mg Zero g Offsett Off TA 25 over lifetime 150 150 Mg Zero g Offset Temper...

Страница 49: ...e measurement range TS 30 97 5 5 C Temperature Offset OffT Calibrated at 30 C 1 K Mechanical Characteristics Cross Axis Sensitivity S Relative contribution between 3 axes 2 Mechanical Shock Duration 100 s 10 000 G Duration 1 0ms 2 000 G Free fall onto hard surface 1 5 M ESD HBM at any pin 2 kV CDM 500 V Specifications are subject to change without notice Please contact AFrame Digital Inc for curre...

Страница 50: ...tware Manager Interfaces Serial ConnectPort X4 o 1 RS 232 DB 9M serial port o Throughput up to 230 Kbps o Full signal support for TXD RXD RTS CTS DTR DSR and DCD o Hardware and software flow control USB o ConnectPort X4 1 Powered USB Type A connector Host See www digi com products wireless usb peripherals for the list of supported USB devices Ethernet o 1 RJ 45 port o Standard IEEE 802 3 o Physica...

Страница 51: ...obile Certifications GSM UMTS PTCRB NAPRD 03 GCF CC R TTE EN 301 511 Power Requirements Power input o ConnectPort X4 6 30VDC o 12V DC power supply for 0 C to 60 C 32 F to 140 F with locking barrel connector included extended temperature power supply available separately Power consumption o ConnectPort X4 Idle 1 5 W Max 10 4 W Surge protection with included power supply 4 kV burst EFT per 4 4 2 kV ...

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