AFrame Digital WG2 MobileCare Monitor User Manual Operator s Manual AFrame MCM

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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
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Do Not Distribute or Copy
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MobileCare™ Monitor Operator’s Manual
Table of Contents
Table of Contents......................................................................................................... i
Warnings and Contraindications ................................................................................. ii
Contraindications..................................................................................................... ii
Warnings ................................................................................................................. ii
Cautions ................................................................................................................. iii
Precautions while using MobileCare™ Monitor.......................................................... iv
About this manual ....................................................................................................... v
Audience ................................................................................................................. v
What you will find in this manual ............................................................................. v
Symbols used in this manual.................................................................................. vi
Conventions used in this manual ........................................................................... vi
Assumptions ........................................................................................................... vi
1.0 Introduction ...........................................................................................................1
2.0 System Overview ..................................................................................................3
2.1 How the MobileCare™ Monitor System Works .................................................4
2.2 Overview of myPHD™ ......................................................................................5
2.3 Compliance to Electromagnetic Compatibility Standard ...................................6
3.0 Operating Procedures ...........................................................................................7
3.1 Using myPHD™ ................................................................................................7
3.1.1 Wearing myPHD™ .....................................................................................7
3.1.2 MyPHD™ Batteries.....................................................................................8
3.1.3 Using myPHD™ Buttons ............................................................................8
3.1.4 Checking for Out-of-range Status ...............................................................9
3.1.5 Verifying the Battery Charge.....................................................................10
3.1.6 Sending Emergency Alerts to Caregivers .................................................10
3.1.7 Using the Privacy Button to Temporarily Disable Alerts ...........................12
3.1.8 Impact Sensing and Falls .........................................................................14
3.1.9 Canceling Alerts........................................................................................14
3.1.10 Interpreting Display Messages ...............................................................15
3.2 Using the Charger........................................................................................16
3.3 Using the CareStation™ Software ..................................................................17
4.0 Security ...........................................................................................................18
5.0 Troubleshooting...............................................................................................19
5.1 Troubleshooting myPHD™ and Battery ..........................................................19
5.2 Troubleshooting PANDA .................................................................................19
Appendix A — Warranty ...........................................................................................20
Appendix B — Service ..............................................................................................21
Appendix C — Declarations ......................................................................................22
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MobileCare™ Monitor Operator’s Manual
Warnings and Contraindications
Contraindications
•
•
•
Do not use the device in a Magnetic Resonance Imaging (MRI) environment.
Do not use this device in an explosive atmosphere or in the presence of flammable
anesthetics or gases.
This device is not defibrillation proof per IEC 60601-1:1990 clause 17h.
Warnings
•
•
•
•
Use within its designated range.
This device is intended only as an adjunct in patient assessment. It must be used in
conjunction with other methods of assessing clinical signs and symptoms.
This device should not be used adjacent to or stacked with other equipment. If adjacent
or stacked use cannot be avoided the device should be observed carefully to verify
normal operation.
Need for Spectrum Management: The MobileCare™ Monitor (MCM) system operates in
the 2.4GHz Industrial, Scientific and Medical (ISM) band of radio frequencies. In the
United States, this band is regulated by the FCC as unlicensed radio spectrum. Users of
this spectrum are no guaranteed interference free communications. Note that an RF site
survey must be performed by AFrame Digital Inc., or an authorized agent to ensure
proper operation of the MCM system at a particular location. Certain 2.4GHz devices
such as cordless phones, video transmitters, and some wireless computers are known to
cause unacceptable interference when operating on the same channel as the MCM
system. Users must minimize use of other RF devices in proximity to the MCM system
to ensure proper functioning.
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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
- improperly applied device
Do not sterilize, autoclave, or immerse this device in liquid.
Do not use caustic or abrasive cleaning agents or any cleaning products containing
ammonium chloride.
This equipment complies with IEC 60601-1-2:2004 for electromagnetic compatibility for
medical electrical equipment and/or systems. This standard is designed to provide
reasonable protection against harmful interference in a typical medical installation.
However, because of the proliferation of radio-frequency transmitting equipment and
other sources of electrical noise in health care and other environments, it is possible that
high levels of such interference due to close proximity or the strength of a source might
disrupt the performance of this device. Medical electrical equipment needs special
precautions regarding EMC, and all equipment must be installed and put into service
according to the EMC information specified in this manual.
Portable and mobile RF communications equipment can affect medical electrical
equipment.
Batteries may leak or explode if used or disposed of improperly. Do not 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/EC, do not dispose of this product as unsorted municipal waste. This
device contains WEEE materials. Please contact your distributor regarding take-back or
recycling of the device.
iii
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Precautions while using MobileCare™ Monitor
Read this manual carefully before using the MobileCare™ Monitor System or its associated
components. Follow these precautions:
• Do not use the MobileCare™ Monitor System as a substitute for usual and
customary resident supervision. The MobileCare™ Monitor System is intended to
assist caregivers in providing proper care to individuals.
• Discontinue use of myPHD™ if the patient demonstrates any allergic reaction or
other intolerance to the device.
• General operation of the MobileCare™ Monitor System 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 its
components.
• Do not remove any covers or open any of the components of the MobileCare™
Monitor System. There are no operator serviceable parts within the MobileCare™
Monitor System.
• Follow local governing ordinances and recycling instructions regarding disposal or
recycling of the MobileCare™ Monitor and its components, including batteries.
• Batteries may leak or explode if used or disposed of improperly.
iv
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MobileCare™ Monitor Operator’s Manual
About this manual
Audience
The MobileCare™ Monitor Operator’s Manual is intended for the operators of
MobileCare™ Monitor and its components, that is, the residents, caregivers, nurses,
and administrative staff of the care giving facility.
What you will find in this manual
This manual describes —
• How the MobileCare™ Monitor System 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
The security of the MobileCare™
Monitor System
4.0 Security
How to solve problems with the
functioning of myPHD™ and PANDA
5.0 Troubleshooting
The warranty details, service facilities,
and declarations of the MobileCare™
Monitor System
Appendices
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MobileCare™ Monitor Operator’s Manual
Symbols used in this manual
The following symbols have been used in this manual:
WARNING: Warnings alert you about instructions or procedures
that could be hazardous, if not followed properly.
NOTE: Notes point out something 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
System, that is, the caregivers, nurses, and administrative staff of the care
giving facility.
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MobileCare™ Monitor Operator’s Manual
1.0 Introduction
The MobileCareTM Monitor System is a wireless based health and alert monitoring
system to support residents and caregivers in long term facilities and outpatient
home settings. The system has been designed primarily to monitor residents who
require a greater level of assistance on a 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, caregivers can track the location of
the residents within the premises of the healthcare facility.
Figure 1.1 Sending alerts to the healthcare professionals via the MobileCare™ Monitor System
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Figure 1.2 Healthcare professionals acknowledge the alerts via the MobileCare™ Monitor System
The MobileCare™ Monitor System is intended only as an adjunct in
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 appropriate
healthcare professional.
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2.0 System Overview
The MobileCare™ Monitor System helps healthcare professionals and caregivers to
provide wireless monitoring services for independent and ambulatory residents in
long term care facilities and outpatient home settings. The MobileCare™ Monitor
System is capable of monitoring residents on a continuous basis (24x7). The system
is primarily designed to monitor alerts from these individuals and transmit this data to
servers for storage and processing. The main applications of the MobileCare™
Monitor System are:
• Residents can send emergency and assistance needed alerts to
caregivers.
• Caregivers can keep track of the location of the residents within the
premises.
• 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™ Monitor System consists of the following components (see Figure
2.1):
• Personal Help Device or myPHD™ (also called watch)
• Wireless Network Secure Server
• CareStation™ Software
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Figure 2.1 Different components of the MobileCare™ Monitor System
2.1 How the MobileCare™ Monitor System Works
The myPHDs™ interacts with the wireless network. The wireless network
isstrategically located inside the individual rooms as well as at other locations of the
facility.
The system uses a mesh network to allow individuals to be mobile within the
network. The caregivers receive alerts via a secure Internet browser, cell phones,
PDAs, or other web-enabled phones such as the iPhone. The system can also send
healthcare related information to administrators and other healthcare providers for
analyzing and archiving purposes.
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2.2 Overview of myPHD™
The myPHD™ allows the residents to be mobile while being monitored by the
network. The myPHD™ periodically transmits the location of the resident within the
facility and data to the CareStation™ software. It has two buttons:
o Emergency button – During an emergency, the resident presses this button
to issue an emergency alert to the caregiver’s station.
o Privacy button – The residents use this button to stop sending data to the
CareStation™ Software for a pre-set interval of time.
Figure 2.3 The myPHD™ with buttons.
The myPHD™ also contains:
•
Built-in temperature sensor – provides resident skin (body) temperature 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 charge.
•
Alert indicator – displays to confirm Emergency Button press.
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MobileCare™ Monitor Operator’s Manual
Ensure that the myPHD™ is positioned properly on the monitored
individual’s wrist.
2.3 Compliance to Electromagnetic Compatibility Standard
The MobileCare™ Monitor System complies with International Standard EN 606011-2:2004 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.
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MobileCare™ Monitor Operator’s Manual
3.0 Operating Procedures
This chapter provides instructions on how to wear and operate the myPHD™,
interpret the messages displayed in the panel, and trigger and send emergency
alerts. This chapter explains the features of the CareStation™ Software and the
procedure to respond to alerts, detect the location of residents, and view the
historical data of the residents.
MyPHD™ is the only component of the MobileCareTM Monitor System operated by
the residents. Before using myPHDs™, the operator must ensure the proper
installation of all components of the MobileCare™ Monitor System.
The components of the MobileCare™ Monitor System should not be installed by
the operator. 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 the key component of the MobileCare™ Monitor System to be
worn and operated by the residents or patients. Hence, the operators must
ensure that they thoroughly understand the operating procedures of myPHD™.
3.1.1 Wearing myPHD™
The myPHD™ alerting device resembles a watch and should be worn like a
wristwatch. The watch should be worn continuously. The myPHD™ has built-in
sensors that determine if the device is being worn. The server constantly monitors
these details and raises an alert if a resident removes the myPHD™ from his/her
wrist.
The myPHD™ alerting device should not be exposed to water.
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3.1.2 MyPHD™ Batteries
The batteries in myPHD™ should not be installed or changed by the residents 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 Usage of myPHD™ buttons
Press
Result
Emergency button
Send an emergency alert to the caregiver and
administrative staff. Alert can be cancelled at anytime,
see 3.1.9.
Privacy button
Temporarily stop myPHD™ from sending data to the
AFrame CareStation™ Software. Alert can be
cancelled at anytime, see 3.1.9.
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3.1.4 Checking for Out-of-range Status
The myPHDs™ function properly only when they are within the range of the wireless
routers. If the resident moves out of range of the routers, the myPHD™ will display a
FAILED message and the myPHD™ will be unable to send information and alerts to
the caregiver or administrative staff.
The signal strength indicator on the
myPHD™ display will indicate if the
resident is within range of the wall
routers.
Additionally, if the resident is within
the range, myPHD™ will display the
date and time accurately.
When the resident moves out of the
range of wall routers, the signal
strength indicator will change.
Additionally, a WATCH FAILED
message will flash on the
myPHD™’s display panel.
Normal
Operation
signal –
indicates the
myPHD™ is
within range
of the wall
routers.
Out of Range
signal –
indicates the
myPHD™ is
out of the
range of the
wall routers.
NOTE: Time is set by the MobileCare™
Monitor System automatically when the
watch is in range of the mesh network.
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3.1.5 Verifying the Battery Charge
The charge indicator on the display panel of the myPHD™ will show the remaining
charge of the batteries.
Indicates the
battery
charge level
The above illustration shows the power indicator for an empty battery. In this
scenario, the operator should recharge the myPHD™ using provided charger. If it
still does not function, call the support line of AFrame Digital, Inc.
The myPHD™ alerting device, 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.
3.1.6 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 wireless wall router. See 3.1.4 Checking for Out-of-range Status for
more information.
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The resident should follow these instructions:
1. Press the Emergency button on the
myPHD™.
2. The date, time, and battery indicator
will disappear from the screen, and
the alert indicator flashes.
Alert
Indicator
3. When the alert is transmitted
successfully, the MSG SENT
message will be displayed in the
display panel of the myPHD™.
4. When the administrative staff or
caregiver acknowledges the alert
message, the HELP COMING
message will be displayed in the
display panel of the myPHD™.
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5. Finally, the caregiver who attends to
the call will reset the display back
to normal status from the
CareStation.
See the section 3.3 for more
information on the CareStation
application. and resetting myPHD™
to Normal State.
Pushing the emergency button will generate an alert message overriding the
privacy feature.
3.1.7 Using the Privacy Button to Temporarily Disable 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 server or alerts to the caregiver. In such cases, the residents can
temporarily disable the myPHD™ from sending data for a pre-determined number of
minutes.
1. To temporarily disable the
myPHD™ device from sending data,
press the Privacy button.
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2. On the myPHD™ display panel:
•
•
•
•
The PRV message is displayed
The signal indicator changes to
indicate no signal
The ring around the clock
changes
The device counts down from a
pre-defined number of minutes
If the resident 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.
Countdown
that
indicates 29
minutes of
privacy
period
remaining.
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 data.
The privacy feature can be canceled by pressing the privacy button a second
time. Pressing it a third time restarts the privacy timer.
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3.1.8 Impact Sensing and Falls
The myPHD can be used in a falls reduction program to sense impacts as an
indication of falls. When a resident wearing the watch falls, myPHD detects the
impact and automatically sends an alert to the caregiver with location of the resident
based on proximity information from the mesh network.
The myPHD alerting device, 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 caregiver. Also, if they drop myPHD™ by mistake, they can cancel the
emergency alert before it reaches the caregiver.
You can cancel the alert only before the MSG SENT message is displayed on
the display panel.
1. Before the MSG SENT message
appears on the display panel, press
the Privacy button.
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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 will generate an alert message overriding the
privacy feature.
3.1.10 Interpreting Display Messages
Message Displayed
on myPHD™
Meaning and Actions to be taken
EM MSG CANCLD
Displayed when the resident cancels the emergency
alert before it was sent to the caregiver.
HELP COMING
Displayed when the caregiver acknowledges the
alert.
MSG SENT
Displayed when the alert message has been sent to
the caregiver. The resident must wait for
acknowledgment from the caregiver.
FAILED
Displayed when the resident moves away from the
range of the MobileCare™ Monitor System. In such
situations, instruct the residents to move within the
range.
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Message Displayed
on myPHD™
Meaning and Actions to be taken
NO FNC
Displayed when the resident presses the Privacy
button 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.
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 not send any data to the
server for the indicated number of minutes. If the
resident wants to extend the privacy period for some
more time, he/she should press the Privacy button
again.
PRV nn
WATCH FAILED
Displayed when the alert is not sent or if the
caregiver does not acknowledge the alert. Wait till
the administrative staff rectifies the error.
Table 3.2 Messages displayed in myPHD™
3.2 Using the Charger
For charging the myPHD™ battery, place the myPHD™ watch on the charger as
shown in the following photograph.
Figure 3.2.0: The myPHD™ is placed on the charger.
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The LED on the charger (see the photograph 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.
Solid Green
Blinking Green
Rapidly Flashing Red
Charging Complete
Charger is charging the
myPHD™
Failure
When the myPHD™ is placed on the charger, the myPHD™ display confirms this
event as “CHARGE.”
When the myPHD™ shows “CHARGE”, it enters in to a low power sleep
mode and disables its connection with the network.
3.3 CareStation™ Software
The CareStation™ 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.
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4.0 Security
The AFrame System incorporates best-practice security controls designed to protect
against both anticipated and unanticipated security threats.
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5.0 Troubleshooting
This section describes the troubleshooting procedure for both myPHD™ and
PANDA.
5.1 Troubleshooting myPHD™ and Battery
For the proper working of myPHD™, ensure that:
• Battery is properly charged.
• Unit is functioning.
• Alert is generated when the Emergency 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.
• Network activity light is ON.
• Internet access is functioning properly.
• Check for interference from other RF devices, such as cordless phones,
defective microwaves ovens, wireless security cameras, or other
interfering devices.
For further assistance call (703) 560-0512 or email to support@aframedigital.com.
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Appendix A — Warranty
AFRAME DIGITAL, INCORPORATED (AFRAME) warrants to the purchaser, for a one year period
TM
from the date of initial purchase or service subscription each MobileCare Monitor 2100
(MobileCare™ Monitor 2100). AFRAME shall repair or replace any MobileCare™ Monitor 2100 found
to be defective in accordance with this warranty, free of charge, for which AFRAME has been notified
by the purchaser by serial number that there is a defect, provided said notification occurs within the
applicable warranty period. This warranty shall be the sole and exclusive remedy by the purchaser
hereunder for any MobileCare™ Monitor 2100 delivered to the purchaser which is found to be
defective in any manner whether such remedies be in contract, tort, or by law. This warranty excludes
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 repaired by knowledgeable and specifically trained AFRAME personnel only.
Accordingly, any sign or evidence of opening the MobileCare™ Monitor 2100 or any of its
components, field service by non-AFRAME personnel, tampering, or any kind of misuse or abuse of
the MobileCare™ Monitor 2100, shall void the warranty in its entirety.
DISCLAIMER/EXCLUSIVITY OF WARRANTY:
THE EXPRESS WARRANTY SET FORTH IN THIS MANUAL IS EXLCUSIVE AND NO OTHER
WARRANTY OF ANY KIND WHETHER STATUTORY, WRITTEN, ORAL, OR IMPLIED INCLUDING
WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE OR SETTING SHALL APPLY.
The standard rates and charges in effect will be levied on all non-warranty work.
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MobileCare™ Monitor Operator’s Manual
Appendix B — Service
The MobileCareTM Monitor and its components are precision electronic instruments
and must be repaired only by trained AFrame representatives. Any sign or 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 in effect will be levied on all non-warranty work.
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MobileCare™ Monitor Operator’s Manual
Appendix C — Declarations
See http://www.iec.ch for the FCC and IEC standards.
Federal Communications Commission (FCC) Notice
This device and its battery charger 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.
The device and its charger are also compliant with international safety and
compliance standards for medical devices IEC 60601-1-2. Refer to the following
tables for specific information regarding this device’s compliance with IEC 60601-12.
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
Group 2
RF Emissions CISPR 11
Class B
Harmonic Emissions
IEC 61000-3-2
Yes
Voltage Fluctuations/Flicker
Emissions IEC 61000-3-3
Yes
This device must emit electromagnetic energy in order to perform its
intended function. Nearby electronic equipment may be affected.
This device is suitable for use in all establishments, including domestic
and those directly connected to the public low-voltage power supply
network that supplies buildings used for domestic purposes.
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
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood,
concrete, or ceramic tile.
If floors are covered with
synthetic material,
relative humidity should
be at least 30%.
Electrical Fast Transient/Burst
IEC 61000-4-4
±2 kV for power supply lines
±1 kV for input/output lines
±2 kV for power supply lines
±1 kV for input/output lines
Mains power quality
should be that of a
typical commercial or
hospital environment or
better.
Surge IEC 61000-4-5
±1 kV differential mode
±2 kV common mode
±1 kV differential mode
±2 kV common mode
Mains power quality
should be that of a
typical commercial or
hospital environment or
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MobileCare™ Monitor Operator’s Manual
IMMUNITY TEST
IEC 60601 TEST LEVEL
COMPLIANCE LEVEL
ELECTROMAGNETIC
ENVIRONMENT—
GUIDANCE
better.
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
±5% VT (>95% dip in VT) for 0.5
cycle
±40% VT (60% dip in VT) for 5
cycles
±70% VT (30% dip in VT) for 25
cycles
<5% VT (>95% dip in VT) for 5
sec.
3 A/m
±5% VT (>95% dip in VT) for
0.5 cycle
±40% VT (60% dip in VT) for 5
cycles
±70% VT (30% dip in VT) for
25 cycles
<5% VT (>95% dip in VT) for 5
sec.
Mains power quality
should be that of a
typical commercial or
hospital environment or
better.
Power frequency
magnetic fields should
be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment or better
3 A/m
NOTE: UT 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
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 14MHz
3V/m
30 MHz to 1.0 GHz
3 Vrms
150 kHz to
14MHz
Recommended Separation Distance
d = 1.17 √P
80 MHz to 800 MHz
d = 1.2 √P
800 MHz to 2.5 GHz
d = 2.3 √P
[3] V/m
where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation distance
in meters (m).
Field strengths from fixed RF transmitters, as determined by
an electromagnetic site survey , should be less than the
compliance level in each frequency range.
Interference may occur in the vicinity of equipment marked
with the following symbol:
a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios,
amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the
electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the
measured field strength in the location in which the device is used exceeds the applicable RF compliance level above, the
device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as reorienting or relocating the device.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [3] V/m.
NOTES:
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MobileCare™ Monitor Operator’s Manual
IMMUNITY
TEST
•
•
IEC 60601 TEST
LEVEL
COMPLIANCE
LEVEL
ELECTROMAGNETIC ENVIRONMENT—GUIDANCE
At 80 MHz and 800 MHz, the higher frequency range applies.
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects, and people.
Need for Spectrum Management:
The MCM system operates in the 2.4GHz Industrial, Scientific and Medical (!SM)
band of radio frequencies. In the United States, this band is regulated by the FCC
as unlicensed radio spectrum. Users of this spectrum are no guaranteed
interference free communications. Note that an RF site survey must be performed
by AFrame Digital Inc., or an authorized agent to ensure proper operation of the
MCM system at a particular location. Certain 2.4GHz devices such as cordless
phones, video transmitters, and some wireless computers are known to cause
unacceptable interference when operating on the same channel as the MCM
system. Users must minimize use of other RF devices in proximity to the MCM
system to ensure proper functioning.
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 maintaining a minimum distance between portable and mobile RF
communication equipment (transmitters) and the device as recommended below, according to maximum output power of the
communications equipment.
Separation Distance According to Frequency of Transmitter
Rated Maximum Output Power of Transmitter
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2.5 GHz
d = 1.2 √P
d = 1.2√P
d = 2.3√P
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can
be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of
the transmitter in watts (W) according to the transmitter manufacturer.
NOTES:
•
At 80 MHz and 800 MHz, the higher frequency range applies.
•
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects, and people.
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