Data Critical AVTS1010 AVTS1010 User Manual UserGuide

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EXHIBIT U – User Manual
FCC ID# NMEAVTS1010
DATA CRITICAL CORP.
AlarmView™
Users Guide Document
Precautionary Information
Caution
Instructions - For continued safe use of this equipment, it is necessary
that the listed instructions be followed. However, instructions listed in
this manual in no way supersede established medical procedures
concerning patient care.
Intended Use - The system is intended to monitor various patientmonitoring devices for alarm conditions, and responds by transmitting
message data that includes text information from the patient.
Confirmation - When the system sends out a page, there is NO
confirmation back that the intended pager has successfully received the
page.
Maintenance - Failure on the part of the hospital or institution to
maintain the equipment as outlined in this manual may cause pre-mature
equipment failure.
Installation - The AlarmView System has been installed by qualified
technicians. Modification of this installation may cause undue equipment
failure.
Electromagnetic Interference - The AlarmView System may cause
electromagnetic interference with devices operated in close proximity to
the transmitter (refer to Appendix C).
System Components - Do not spill liquids on any of the AlarmView™
System components.
Warnings
Patient Monitoring - The most reliable method of patient monitoring
combines close personal surveillance with correct operation of
monitoring equipment. Patient alarm conditions and notifications are
primary functions of the patient monitoring system. It is imperative that
the caregiver and/or monitoring floor technicians monitor patient alarm
conditions. The AlarmView System is not intended for use as the
primary source for the patient alarm notification.
Accidental Spills - In the event fluids are accidentally spilled in the
equipment, take the equipment out of service and check for damage.
Check operation after drying 24 hours later.
Antenna Placement - The transmitter unit with a transmitter antenna
may interfere with computer equipment with electronic switchboards
located close to the antenna. If the transmitter unit must be located
close to these types of equipment, a remote antenna should be used.
Change of Performance - If the system fails to page users reliably,
contact the hospital staff responsible for electromagnetic environment
and Data Critical Corp. immediately. (Data Critical Corp. 24 hour support
at 1-877-322-7828)
Electrical Shock - To reduce the risk of electrical shock, DO NOT
remove cover (or back). Refer servicing to qualified personnel.
Environment - Data Critical Corporation does not assume responsibility
for damage to the equipment caused by improperly vented cabinets,
improper or faulty power, or insufficient wall strength to support
equipment mounted on such walls.
Explosion Hazard - Do not use this equipment in the presence of
flammable anesthetics, skin cleaning agents, and disinfectants. Great
care must be exercised when the device is used in an oxygen-enriched
atmosphere. The atmosphere is considered to be oxygen enriched when
the room air contains more than 25% of oxygen or nitrous oxide.
Home Use - AlarmView™ System is not intended for home use.
Power - Convenience outlets and all others that may be used for the
patient must be on the hospital emergency circuit so that they are
energized at all times.
Site Surveys - Each institution is responsible for surveying existing
equipment and ensuring no conflict exists when considering the
introduction of additional radiating devices.
Transmission Bands - Each institution is responsible for maintaining
continued surveillance of transmission bands being used in the facility to
prevent co-occupation of bands and cross-band interference.
Indications for Use
This device is intended for use in real-time monitoring of routine patient
status and alarm events on medical devices. It serves as a parallel,
redundant mechanism to inform the clinical staff of patient events. It is
intended to be a secondary means of annunciating and displaying patient
alarm information to mobile healthcare providers.
AlarmView is limited to use by qualified medical professionals who have
been trained on the use of the device. It is intended for use in hospital
and hospital type environments and is not for home use.
AlarmView is intended to supplement and not to replace any part of the
current device monitoring procedures.
AlarmView is not considered in and of itself to be diagnostic without
skilled interpretation and does not replace physician’s care.
AlarmView is currently validated for use with the N-x9y and the N-3000
data protocols.
Please note that we have demonstrated compatibility with the data
protocols that Nellcor Puritan Bennett has defined, not the individual
monitors. However, for FDA reference, the chart below indicates all
models using the protocol. Data Critical is compatible with all the listed
monitors.
Protocol:
All Current Models:
N-x9y
N-3000
N-290, N-295
N-3000
For devices not listed in the above compatibility chart, a separation
distance of 5.5 feet between the AlarmView Transmitter and other
emitting devices should be observed.
For the devices listed on the above compatibility chart, the AlarmView
Transmitter may be placed in either of the configurations described
below:
•
•
The AlarmView transmitter can be located remotely from the
patient device (e.g. place the AlarmView Transmitter on the
wall instead of the patient monitoring equipment).
When placing the AlarmView Transmitter in close proximity
to the patient monitoring equipment, place it as shown in the
drawing below, using the velcro attachment provided:
Alarm Data
The alarm data that the AlarmView system echoes are listed in the
following chart.
Alarm
Nx9y
N3000
SPO2 Upper Limit
SPO2 Lower Limit
PR Upper Limit
PR Lower Limit
No Pulse Motion
No Pulse No Motion
Sensor Disconnect
HR Upper Limit
HR Lower Limit
Asystole
ECG Lead Off
ECG Cable Off
ECG Operations Error
ECG Noise
RR Upper Limit
RR Lower Limit
Apnea
Respiration Lead Off
Respiration Cable Off
Respiration Ops Error
Respiration Noise
Low Monitor Battery
It should be emphasized that this alarm data is passed to AlarmView via
simple text strings. No interpretation of this information is made.
Whatever the monitor passes AlarmView is what will be passed through
and transmitted to the nurse.
Also, these alarm modes are determined by the protocols we are
claiming compatibility with: N-x9y and N-3000.
Service and Technical Support
Direct all inquires to:
Data Critical Corporation
19820 North Creek Parkway
Suite 100
Bothell, WA 98011
For technical advice or information concerning any equipment in your
AlarmView™ System, contact Technical Support. Call, toll free at 1-877DCC-STAT (1-877-322-7828).
Copyright © 1998-1999 Data Critical Corp. All Rights Reserved.
Conventions of this Manual
Two items that may help you as you work through the AlarmView User’s
Guide are the special notes and cautions that appear throughout this
text. Individual icons identify these notes and cautions, and they alert
you to special information.
NOTE
The Caution icon alerts you to possible problems that
you may encounter as you work through the
AlarmView™ System programs. The possibility of
losing data, for example, is information that could be
mentioned in a caution.
The Note icon alerts you to tips or hints that may make
it easier for you to work within AlarmView System
programs. These might include data entry tips,
additional information about a window or field, or
recommended procedures.
NOTE: Due to continuing product innovation, specifications in this
manual are subject to change without notice.
Trademarks:
Nellcor Puritan Bennett™ are registered trademarks of Nellcor Puritan
Bennett, Inc.
Windows™ CE is a registered trademark of Microsoft Corporation.
AlarmView™ System is registered trademark of Data Critical
Corporation.
Introduction
AlarmView™ System Product Description
The AlarmView System is a secondary alarm notification system that
transmits alarm data from Primary Patient Monitoring Equipment (PME)
to pagers that are worn by caregivers.
•
The AlarmView Pager - The AlarmView Pager is an off the
shelf pager that is worn by caregivers responsible for
individual patient care.
•
The AlarmView Programmer - The AlarmView
Programmer is an off the shelf Personal Digital Assistant
(PDA) with Windows CE operating system and equipped
with AlarmView programming software. The PDA needs to
have an infrared (IR) port to communicate with the
transmitter.
§
The AlarmView Transmitter - The AlarmView Transmitter
is connected to the Patient Monitoring Equipment (PME)
(i.e., Nellcor Puritan Bennett Pulse Oximeter – NPB-290,
NPB-295, NPB-3000) with an AlarmView cable that is
connected to the PME’s serial port.
AlarmView System Diagram
AlarmView™ System
System Components
Transmitter
The transmitter is Data Critical Corporation’s proprietary RF transmitter
operating in the UHF band (450-466MHz). It has an a BNC connector
for the antenna needed for the RF transmissions, an IR port used for
setup, a button for power on/off and certain user initiated transmissions,
and an RJ-45 connector for connection with the Patient Monitoring
Equipment.

Pager
The pager is a 4 by 20 character text based, off the shelf pager operating
in the UHF band (450-466MHz), and able to receive POCSAG encoded
pages.

PDA (Personal Digital Assistant) Programmer
The PDA programmer is an off the shelf Personal Digital Assistant with
Windows CE operating system and equipped with AlarmView
programming software. The PDA programmer includes an IR port for
communications with the transmitter. At least one PDA running Windows
CE with AlarmView software is needed to be used for user programming
of the transmitters.

Monitoring Device Types
The AlarmView software is currently configured to be compatible with
Nellcor Puritan Bennett Pulse Oximeters N-290, N-295, or N-3000.

Getting Started
Before turning on the transmitter, ensure that the antenna is attached to
the transmitter. The antenna is attached to the transmitter via a BNC
connector found on the back of the transmitter (directly behind the LED).
The power cable is attached on the back of the transmitter to the far
right. The unit can now be turned on by pressing the button on the top of
the transmitter.

Survey Mode
The Survey Mode is a mode in which frequent periodic pages are sent
from the transmitter to the assigned pager(s). To begin the Survey
Mode, turn on the transmitter, as described above. The transmitter
should not be attached to any patient monitoring equipment as this point.
The LED on the front of the transmitter will be ORANGE to indicate that
the transmitter is attempting to establish communications with the patient
monitoring equipment. Press the button on the top of the transmitter,
and hold the button down for approximately 5 seconds. A numbered
“Survey Page” will be sent. Every 15 seconds, another “Survey Page”
will be sent. This will continue until one hundred pages have been sent.
To stop the survey mode before one hundred pages have been sent,
press the button on the top of the transmitter, and hold the button down
for approximately 5 seconds.
Pages sent during the Survey Mode will have a line of data, which will
indicate that the Survey Mode is in process.
Pages sent during the Survey Mode will contain the following data:
Bed Number
Transmission Number (in sequence)

Programming Mode
The Programming Mode is the mode in which the PDA is used to change
or view the current setup (i.e. the bed number and the pager cap codes)
of the transmitter. To program the transmitter, the transmitter must be
trying to establish communications with the patient monitoring equipment
(the LED is ORANGE), or have established communications with the
patient monitoring equipment (the LED is GREEN).
The Editor Program
Turn the PDA “ON”. The first screen of the PDA will appear and will
resemble the screen below.
Select the Windows Start menu button.
From the Windows Start menu, select the “AV System Manager”
program.
The AlarmView System Manager main screen will appear as shown
below.
Tap the About button for information about the System Manager
software.
Tap the OK Button to return from this dialog box.
Now tap the Editor Button on the Main Screen. The following warning
will appear.
Pressing the “No Button” will return the user to the AlarmView System
Manager main screen. Pressing the “Yes Button” will launch the
“AlarmView Editor” program. This is the program used to setup which
bed number and cap codes are present in the system. It can be
reconfigured when pagers are sent back to the factory, or new pagers
are obtained.
To configure the bed numbers available in the system, tap the Bed
Numbers 1 - 24 tab or the Bed Numbers 24 – 48 tab. The first tab lists
the first 24 bed numbers available to the system. The second tab lists
the last 24 bed numbers available to the system. It is not necessary to
fill in all 48 slots.
Below is the Bed Numbers 1 – 24 screen.
Below is the Bed Numbers 24 – 48 screen. Note that the “active” tab is
displayed in all caps.
Bed Numbers can be added and deleted from this list. Click on a bed
number to edit. Using the stylus, tap the backspace key on the keyboard
to delete the bed number to be edited (or highlight the entire bed number
as shown below), and using the numbers and letters on the key board,
type in the new bed number. Tap the “Save” button on completion, or
the “Exit” button to exit the Editor Program.
If the key board is not visible, tap the keyboard icon to display the
keyboard. If an additional bed number is desired, a bed number can be
added to any blank space on page one or two of the bed number listing.
Simply tap the cursor in the blank space and begin typing the new bed
number.
To edit the pager numbers, tap the “Pagers” tab on the upper right of the
screen. The “AlarmView Editor” Screen Pagers page will appear.
Pager Cap Codes can be added and deleted from this list. Click on a
cap code number to edit. Using the stylus, tap the backspace key on the
keyboard to delete the cap code number to be edited (or highlight the
entire cap code number), and using the numbers and letters on the key
board, type in the new cap code number. Tap the “Save” button on
completion, or the “Exit” button to exit the Editor Program.
If the key board is not visible, tap the keyboard icon to display the
keyboard. If an additional bed number is desired, a bed number can be
added to any blank space on page one or two of the bed number listing.
Simply tap the cursor in the blank space and begin typing the new bed
number.
Note that the global cap code value can not be changed by the user.
To restore values to the state they were in before editing began, tap the
Restore Button on any of the pages before pressing the Save Button.
Once the Save Button has been pressed, however, the original values
are not restored.
When the “Editor Program” is exited, the Main Screen is again displayed.
The Configuration Program
If the main PDA screen is displayed, tap Windows Start menu button.
From the Windows Start menu, select the “AV System Manager
program.
The AlarmView System Manager main screen will appear as shown
below.
To launch the Configuration Program, tap the Programming button. The
“Configuration Program” Main Screen will appear. This program is used
to change the transmitter’s setup of bed numbers, cap codes, alarm
severity, and reminder page interval. It also displays information that can
not be modified by the user. This information includes: monitor identifier
(N3000, N295, N290), transmitter number, hardware version, software
version, protocol version, authorize identification, paging frequency, and
paging baud rate. This program can be used at shift change, or
whenever there is a need to change/view the current transmitter
configuration.
To obtain the current configuration programmed into the transmitter, tap
the “Download Configuration Button”. When this button is tapped, the
PDA attempts to establish communications with the transmitter. If the IR
port could not be accessed, the following dialog box will be displayed.
Tap the OK button to close this dialog box and return to the
Configuration Program main screen.
If the IR port could be accessed, but communications could not be
established between the PDA and the transmitter, the following error
dialog box will be displayed:
When “OK” is tapped on this dialog box, the Configuration Program main
screen will be displayed with a status message informing the user of a
“Failed to Connect” status.
At this point, simply point the PDA at the transmitter, and tap the
“Download Configuration Button” again. While the transmitter is being
queried, the Configuration Program main screen will be displayed with a
status message informing the user of a “Loading Data” status. The PDA
will be in this state for less than 2 seconds.
When the transmitter has been successfully queried, the Configuration
program main screen will be displayed with a status message informing
the user of a “Transmitter Data Loaded” status.
At this point, if the displayed data is correct, no changes need be made,
and the user is done. Exit the Configuration Program by tapping the “X”
in the upper right corner of the screen.
If the data needs to be changed, the Patient Bed Number can be
selected by tapping on the bed number drop down list, and highlighting
the desired bed number.
A maximum of two pagers can be selected by clicking the radio button
next to the desired pager number.
To change/view alarm severity selection or reminder page intervals, tap
the Advanced Setup Button on the upper left of the screen. If no data
has been previously downloaded, the PDA will attempt to establish
communications with the transmitter. When the data is downloaded, the
following screen will appear.
Alarm Severity selections:
Send All Alarms indicates that all alarms will be sent to the pagers
regardless of the severity of the alarms.
Only Critical Alarms indicates that only critical (high prioirty and medium
priority) alarms will be sent to the pagers.
Reminder interval indicates the time interval at which reminders will be
sent after the original alarm has not been silenced.
Tap the OK button when all changes have been made.
To view transmitter data that can not be modified by the user, tap the
Current Configuration Button on the upper left of the screen. If no data
has been previously downloaded, the PDA will attempt to establish
communications with the transmitter. When the data is downloaded, the
following screen will appear.
Tap the “Program Transmitter” button to program the transmitter with the
newly selected values.
If no bed number was selected before the “Program” button was tapped,
the following error dialog box will appear.
If no cap code was selected before the “Program” button was tapped, the
following error dialog box will appear.
Exit both of the above dialog boxes by tapping the OK Button. After the
above error conditions are rectified, tap the “Program Transmitter” button
again. When this button is tapped, the PDA attempts to establish
communications with the transmitter.
If the IR port could not be accessed, the following dialog box will be
displayed.
Tap the OK button to close this dialog box and return to the
Configuration Program main screen.
If the IR port could be accessed, but communications could not be
established between the PDA and the transmitter, the following error
dialog box will be displayed:
When “OK” is tapped on this dialog box, the Configuration Program main
screen will be displayed with a status message informing the user of a
“Failed to Connect” status.
At this point, simply point the PDA at the transmitter, and tap the
“Program Transmitter Button” again. While the transmitter is being
queried, the Configuration Program main screen will be displayed with a
status message informing the user of a “Programming” status. The PDA
will be in this state for less than 2 seconds.
When the transmitter is successfully programmed, the Configuration
Program main screen will be displayed with a status message informing
the user of a “Programming Successful” status.
A “Programming Successful” page will also be sent to the newly selected
pagers, displaying the newly selected bed number.

Exit the “Configuration” program by tapping the “X” in the upper right
corner of the screen.
When the Configuration Program has been exited, the System Manager
Program main screen will be displayed as shown:
Exit this program by tapping the Exit Button in the upper left of the
screen.
Communicating With Patient
Monitoring Equipment
Turn on the transmitter, as described above. Attach the serial cable to
the RJ-45 port. Attach the other end of the cable to the patient
monitoring equipment. The transmitter will automatically detect the
monitor (assuming it is an N-3000, N-295, or N-290). Once
communications have been established with the patient monitoring
equipment, a page will be sent to the pager indicating this, and the LED
will turn GREEN.
The communications established page will have the following data:
Bed: xxxxx
Comms OK

From that point, all alarms at the patient monitoring equipment will be
sent to the pager(s), as assigned by the PDA (as described above).
Turn on the transmitter, as described above, and establish
communications with the patient monitoring equipment (the LED will be
transmitter (but, do not hold it down). A “Test Page” will be sent
indicating the current patient data (SPO2, and Pulse Rate). Note that
Test Page
Bed: xxxxx
SPO2: xxx

The transmitter can only be turned off if it is not communicating with the
patient monitoring equipment (i.e. the LED is RED). To turn off the
goes off.
Communications Not
Established
Turn on the transmitter, as described above. The transmitter should not
be attached to any patient monitoring equipment as this point. The LED
on the front of the transmitter will be ORANGE to indicate that the
transmitter is attempting to establish communications with the patient
monitoring equipment. After 10 seconds of no communications, a page
will be sent indicating that no communications have been established.
Bed: xxxx
Comm Fail
Retrying

Every 10 minutes after that, another page will be sent indicating that
communications have not been established. This will continue for one
hour. At this point, a page will be sent indicating that the transmitter is
turning off.
Bed: xxxx
Comm Fail
Tx Shut down

Low Battery Warnings
If the battery becomes too low for proper transmitter functioning, an
alarm will be sent indicating the low battery situation, and the transmitter
will be shut down.
Bed: xxxx
Low Tx Battery
Tx Shut down

Appendix A
Electromagnetic Interference
It is a known fact that electronic devices that emit radio frequencies may
interfere with the operation of other electronic devices. This has become
proliferation of intentional electronic radiators such as cellular phones,
paging systems, walkie-talkies, and wireless network LANs. The critical
are of special concern and incidents have been observed with apnea
monitors, wheel chairs, and ventilators.
to address this complicated issue through their respective working
groups. The ANSI C63.6 working group made up of industry and the
means to evaluate critical care medical devices for electromagnetic
interference problems by the clinical and biomedical staff using an ad
EMI fundamentals. A possible outline for management of potential EMI
sources and education of the hospital staff is as follows:
environment of their hospital and take actions on:
• managing (increasing) distance between sources of EMI and
susceptible devices
managing use of frequencies close to StatView™ System
•
•
EMI
lower power from internal EMI sources under hospital control
(paging systems)
labeling devices susceptible to EMI
•
•
•
•
educating staff (nurses and doctors) to be aware of, and to
recognize, potential EMI related problems
conducting technical remedial action to eliminate EMI, such
as shielding
sharing relevant EMI/EMC information with others, especially
in evaluation of new equipment purchases which may have
emissions
identifying critical areas where life-support devices are in use
and restricting the use of personal communicators (cellular
phones) in those critical care areas
Purchase critical care devices that comply with IEC 601-1-2 EMC
standards:
• the required level of EMI immunity is 3 volts per meter
• the interference level that a medical device can radiate
(emit) is 0.0014 volts per meter
The AlarmView™ System has a transmit power level of up to 1 watt peak
at a pre selected RF frequency between 450 MHz to 466 MHz
Protection Distance Estimate
Immunity of Medical Device
of
2 V/meter
1 watt
x ft
xm
x ft
xm
x ft
xm
Appendix B
Terms Glossary
BNC Connector:
A type of connector used with coaxial cables. The
basic BNC connector is a male type mounted at
each end of a cable. This connector has a center
pin connected to the center cable conductor and a
metal tube connected to the outer cable shield. A
rotating ring outside the tube locks the cable to
any female connector. This is the type of
connector that the antenna uses to connect to the
transmitter.
IR Port:
Infrared port. An IR Port is used by the PDA to
communicate with the transmitter.
PDA:
Personal Digital Assistant (Win CE Device)
POCSAG:
Post Office Code Standardization Advisory Group
– the protocol used for pager communications
RF Transmissions:
Radio Frequency transmissions
RJ-45 Connector:
Short for Registered Jack-45, an eight-wire
connector commonly used to connect computers.
Looks similar to the connectors used for
connecting telephone equipment, but they are
somewhat wider.
UHF Band:
Ultra High Frequency Bandwidth
Windows CE:
The operating system of the PDA

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