EXHIBIT T – Service Manual FCC ID# NMEAVTS1010
AlarmView™ Service and Installation Manual DATA CRITICAL CORP.
AlarmView™ Service and Installation Manual 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 patient-monitoring devices for alarm conditions, and responds by transmitting message data that includes text information from the patient.
AlarmView™ Service and Installation Manual 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.
AlarmView™ Service and Installation Manual 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.
AlarmView™ Service and Installation Manual 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.
AlarmView™ Service and Installation Manual Purpose The technical publications staff of Data Critical Corporation. prepared this service manual for the AlarmView system. This manual is geared for qualified service representatives and technical personnel involved in maintaining and repairing the AlarmView system. This manual is geared toward trained biomedical engineers.
AlarmView™ Service and Installation Manual Service Information Service Requirements Follow the service requirements listed below. v Refer equipment servicing to Data Critical Corporation authorized service personnel only. v Any unauthorized attempt to repair equipment under warranty voids that warranty. v It is the user’s responsibility to report the need for service to Data Critical Corporation or to one of their authorized agents.
AlarmView™ Service and Installation Manual 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.
AlarmView™ Service and Installation Manual AlarmView System Diagram Page 9
AlarmView™ Service and Installation Manual AlarmView System Components AlarmView Transmitter The AlarmView transmitter is a device which interfaces to the PME and relays patient alarm information to clinician-worn receivers. The data relayed from the monitoring system includes patient bed number, alarm type, and parameter values (heart rate and SPO2 values).
AlarmView™ Service and Installation Manual Monitoring Device Types The AlarmView software is currently configured to be compatible with the following devices: Nellcor Puritan Bennett Pulse Oximeter N-290 Nellcor Puritan Bennett Pulse Oximeter N-295 Nellcor Puritan Bennett Pulse Oximeter N-3000 Controls, Indicators, and Symbols < > Installation Unpacking and Inspection Be sure to carefully unpack all components carefully. If any boxes appear damaged in any way, contact the carrier.
AlarmView™ Service and Installation Manual List of Components Please check that all of the following components are present: AlarmView Transmitter 7” Antenna Power Cable for Transmitter Battery for Transmitter AlarmView Programmer Programmer Charging Cradle Programmer Batteries AlarmView Pager Pager Batteries Serial Cable for Connection from AlarmView Transmitter to PME Setup Attach the antenna to the AlarmView transmitter. Power the AlarmView transmitter. Attach the monitor to the AlarmView transmitter.
AlarmView™ Service and Installation Manual Range Verification and Measurement Range verification is discussed in detail in the Quick Start section below. Basic Setup The AlarmView system come from the factory with certain preset defaults. Some of these values may be modified by the user. Factory Default Settings AlarmView Pager Notification Mode: Cap Code: Frequency: Display: Audible 0000009 464.
AlarmView™ Service and Installation Manual Adjustable Settings Some settings can be changed by the user. All settings that can be changed in the transmitter are described in detail below in the Quick Start section. To make changes to the other equipment, see the manufacturer’s documentation. AlarmView Pager Notification Mode: Cap Code: Frequency: Display: Audible 0000009 464.
AlarmView™ Service and Installation Manual Another possible error message pages would be a loss of communications with the PME: Comm Fail Retrying Comms If, after an hour, communications is not established, a shut down message will be sent Comm Fail Tx Shut Down The AlarmView Programmer will also post error messages encountered during communications with the transmitter.
AlarmView™ Service and Installation Manual If no bed number was selected before the “Program” button was tapped, the AlarmView Programmer will post the following message in an advisory dialog box. You must select or get a bed number. If no cap code was selected before the “Program” button was tapped, the AlarmView Programmer will post the following message in an advisory dialog box. You must select or get one or more pagers.
AlarmView™ Service and Installation Manual Suggested Corrective Actions Error Low Transmitter Battery Communication Failure Unable to access port IR port not pointed at transmitter/ Failed To Connect Must select a bed number Must select a cap code Programming Failed Corrective Action Plug in the transmitter to wall power to recharge the battery. Ensure that the transmitter is connected via the serial cable to the PME. Ensure that the PME is plugged in. Reboot the Programmer.
AlarmView™ Service and Installation Manual The report provides background information and basic EMI fundamentals.
AlarmView™ Service and Installation Manual 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 Peak Power of Transmitter 1 watt 1 watt Immunity of Medical Device 1 V/meter 2 V/meter 3 V/meter x ft xm x ft xm x ft xm Obtaining 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 e
AlarmView™ Service and Installation Manual Maintenance Service The AlarmView™ Pager Changing the battery The AlarmView™ Pager requires one AAA alkaline battery. • • • • • Use only 1.5 Volt AAA alkaline battery. Observe proper polarity when installing battery. Do not dispose of battery in fire. Do not attempt to recharge alkaline batteries. Remove battery from pager if the pager will not be used for 2 days or more.
AlarmView™ Service and Installation Manual Pager Maintenance • Visual Inspection Be sure to inspect the AlarmView™ Pager unit frequently. Check the case for cracks or other damage. • Cleaning Procedures To avoid damage to the device surfaces, do not use the following cleaning agents: organic solvents, acetone solution, alcohol-based cleaning agents, Betadine solution, a wax containing cleaning substance, or abrasive cleaning agents.
AlarmView™ Service and Installation Manual The AlarmView™ Programmer Changing the battery The AlarmView™ Programmer requires two AAA alkaline battery, and one CR2016 battery. • • • • Observe proper polarity when installing battery. Do not dispose of battery in fire. Do not attempt to recharge alkaline batteries. Remove battery from PDA if the PDA will not be used for 2 days or more.
AlarmView™ Service and Installation Manual PDA Maintenance • Visual Inspection Be sure to inspect the AlarmView™ PDA unit frequently. Check the case for cracks or other damage. • Cleaning Procedures To avoid damage to the device surfaces, do not use the following cleaning agents: organic solvents, acetone solution, alcohol-based cleaning agents, Betadine solution, a wax containing cleaning substance, or abrasive cleaning agents.
AlarmView™ Service and Installation Manual Overview AlarmView Transmitter v The transmitter operates at one of several frequencies. The frequency of the transmitter must match the frequency of the pagers installed on the system. The transmitter has a range of approximately 300 feet. This range is site-specific and influenced by factors such as antenna placement and building construction. AlarmView Pager The AlarmView pagers are small, battery-operated pagers that can be worn on a belt.
AlarmView™ Service and Installation Manual Installing the Equipment Pre-Installation Requirements Power Requirements One properly grounded duplex wall receptacle should be provided for each system. Additional receptacles may be required to accommodate peripheral equipment connected to the system. The wall receptacle must be installed in an approved junction box. Use only 3-prong, polarized, medical-grade wall receptacles to accept the 3-prong, polarized, medical-grade plug on the computer equipment.
AlarmView™ Service and Installation Manual v The grounding system must not carry current, such as grounded neutral, since the current flow produces potential differences along the ground path. These potential differences are a shock hazard source for equipment users and patients. v Do not use conduit as a ground conductor. Plastic (PVC) piping or fittings used in the conduit runs can break the electrical connection to ground, resulting in potential shock hazards.
AlarmView™ Service and Installation Manual v Power for all peripheral equipment is installed, tested, and ready for use. This includes testing for proper grounding of the power source. v All equipment, including all peripheral devices, must be unpacked and ready for installation. All required cables must be identified and prepared for installation. v Install the transmitter at the desired location. v Connect the transmitter to the power source. v Connect the antenna to the transmitter.
AlarmView™ Service and Installation Manual AlarmView Quick Start Configuring the System 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).
AlarmView™ Service and Installation Manual 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.
AlarmView™ Service and Installation Manual The AlarmView System Manager main screen will appear as shown below.
AlarmView™ Service and Installation Manual Tap the About button for information about the System Manager software. Tap the OK Button to return from this dialog box.
AlarmView™ Service and Installation Manual 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.
AlarmView™ Service and Installation Manual 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.
AlarmView™ Service and Installation Manual Below is the Bed Numbers 24 – 48 screen. Note that the “active” tab is displayed in all caps.
AlarmView™ Service and Installation Manual 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.
AlarmView™ Service and Installation Manual If the keyboard 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.
AlarmView™ Service and Installation Manual 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.
AlarmView™ Service and Installation Manual When the “Editor Program” is exited, the Main Screen is again displayed.
AlarmView™ Service and Installation Manual 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.
AlarmView™ Service and Installation Manual The AlarmView System Manager main screen will appear as shown below.
AlarmView™ Service and Installation Manual 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.
AlarmView™ Service and Installation Manual 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.
AlarmView™ Service and Installation Manual 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.
AlarmView™ Service and Installation Manual 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.
AlarmView™ Service and Installation Manual 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.
AlarmView™ Service and Installation Manual 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.
AlarmView™ Service and Installation Manual 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 priority 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.
AlarmView™ Service and Installation Manual 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.
AlarmView™ Service and Installation Manual 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.
AlarmView™ Service and Installation Manual 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.
AlarmView™ Service and Installation Manual 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.
AlarmView™ Service and Installation Manual 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.
AlarmView™ Service and Installation Manual 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.
AlarmView™ Service and Installation Manual Survey Pages The Survey Mode is a mode in which frequent periodic pages are sent from the transmitter to the assigned pager(s). This mode can be used to determine areas of coverage for the system. 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.
AlarmView™ Service and Installation Manual 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.
AlarmView™ Service and Installation Manual Test Pages Test pages can be used to verify proper communications with the patient monitor. Turn on the transmitter, as described above, and establish communications with the patient monitoring equipment (the LED will be GREEN). Once communications is established, press the button on the transmitter (but, do not hold it down). A “Test Page” will be sent indicating the current patient data (SPO2, and Pulse Rate).
AlarmView™ Service and Installation Manual Glossary BNC Connector: IR Port: PDA: POCSAG: RF Transmissions: RJ-45 Connector: UHF Band: Windows CE: 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.
