EXHIBIT DD – Revised Service Manual FCC ID# NMEAVTS1010
Data Critical Corp.
AlarmView™ is a trademark of Data Critical Corp. Nellcor Puritan Bennett Inc. is a wholly owned subsidiary of Mallinckrodt Inc. Nellcor™ is a trademark of Mallinckrodt Inc. Microsoft® and Windows® CE are registered trademarks of Microsoft Corporation. Compac® and Aero® are registered trademarks of Compaq Computer Corporation. All other trademarks and registered trademarks are the property of their respective owners. © 2000 Data Critical Corp. All rights reserved.
AlarmView™ Wireless Data Network System Administrator’s Manual Table of Contents USING THIS MANUAL................................................................................ 1 Procedures ........................................................................................ 1 Cautions ............................................................................................ 1 Notes.................................................................................................
Operating Transmitter On Battery Power.......................................... 22 SECTION 4: PROGRAMMING ................................................................... 23 Using Programmer........................................................................... 23 Changing System Parameters ......................................................... 24 Changing System Password......................................................... 25 Changing Individual Transmitter Assignments.......................
AlarmView™ System User’s Guide Using this Manual Procedures As you work through this manual, steps to perform are numbered in sequence if there is more than one step in the procedure (single steps will be marked with a bullet). For example: 1. Turn monitor off or disconnect cable from transmitter. 2. Press On/Off button on transmitter. Cautions Cautions alert you to actions or conditions necessary for the safe use of the equipment to prevent damage or malfunction.
AlarmView™ System User’s Guide For Basic Operations This manual contains information on AlarmView system specifications, system configuration, programming, testing, maintenance, and troubleshooting. Only qualified personnel should service the AlarmView System. You should also review the AlarmView™ Wireless Data Networking System User’s Guide carefully to gain a complete understanding of AlarmView System daily operations not covered in this manual.
AlarmView™ System User’s Guide Safety Information System Warnings ! Warnings alert you to potential serious outcomes (including death, injury, or adverse events) to the patient or user. v Patient Monitoring – The most reliable method of patient monitoring combines close personal surveillance with correct operation of monitoring equipment. v Secondary Patient Monitoring System – The bedside monitor and central station make up the patient monitoring system.
AlarmView™ System User’s Guide closer than 20 cm to a person’s body or head will void the user’s FCC authority to operate the equipment. v Transmitter Placement – Do not place transmitter in any position where it might fall on and potentially harm patient. Do not lift transmitter or connected monitor by interface cable or power cord, as they may become disconnected and cause transmitter and/or monitor to fall on and potentially harm patient.
AlarmView™ System User’s Guide v IEC Standards – Verify proper operation and compliance with IEC standards of all instruments before clinical use. Connecting additional equipment to the signal port of the monitor constitutes configuring a medical system.
AlarmView™ System User’s Guide Section 1: AlarmView™ System Overview Introduction The AlarmView System is a complete, secondary patient monitoring system. AlarmView notifies caregivers of patient events using a wireless network that supplements the primary notification system. AlarmView is installed in care units where Nellcor NPB-290, NPB-295, N395, and N-3000 pulse oximetry monitors are used.
AlarmView™ System User’s Guide displays immediate information about the patient and type of alarm. If an alarm continues unattended, a Reminder Page is sent to all pagers in the unit. ! Pager coverage is limited and designed to cover a care unit. Operating range from transmitter to pager is approximately 150 feet with no intervening structures (walls, columns, doors, floors, etc.). Coverage is not long range.
AlarmView™ System User’s Guide § Transmitter Power Supply (1 per transmitter, to 24) § Hospital-grade AC Power Cord (1 per transmitter, to 24) § Handheld Programmer (1) § Rechargeable AAA Battery Pack for Programmer (1) § Programmer Docking Station (1) § AC Adapter Cord for Programmer Docking Station (1) § Pager with Holder (up to 12) § AlarmView System User’s Guide § AlarmView System Administrator’s Manual (this manual) System Features Transmitter The AlarmView Transmitter interfaces wit
AlarmView™ System User’s Guide {Insert graphic of top panel (Figure 1-2)} Transmitter Top View On/Off button is also used to initiate Test Pages, and to select All Pagers from the transmitter. Front Panel {Insert graphic of front panel (Figure 1-3)} Transmitter Front View AC Indicator is Off when not connected to AC power. Green when connected to AC power (battery is also charging). Transmitting Indicator is Off when transmitter is not attempting to transmit.
AlarmView™ System User’s Guide Transmitter Rear View Monitor Input and Power Input ports. Bottom Panel Warning This symbol warns user to read the instructions before using the transmitter. Type B This symbol indicates that transmitter is not defibrillator-proof. Programmer The AlarmView Programmer is a handheld computing device (PDA) that is used to setup and change the configuration of the AlarmView transmitter.
AlarmView™ System User’s Guide Pager The AlarmView Pager is worn by caregivers assigned to monitor patients. It is intended as an additional means of receiving patient alarm information. Within seconds of detecting an alarm identified by the oximetry monitor, the transmitter sends an Initial Alarm Page to its assigned pager(s) only. Each transmitter can be programmed to send the Initial Alarm Page to one pager, two pagers, or all pagers.
AlarmView™ System User’s Guide Alarm Pages ! The pager must be turned on to receive pages. Do not turn the pager off at any time when being used for alarm notification. Doing so may result in failure to receive notice of a patient alarm. Alarm pages are prioritized for four (4) event levels (4=immediate, 3=high, 2=medium, 1=low). The transmitter will send alarm pages to the pager in a format similar to the following example.
AlarmView™ System User’s Guide Section 2: System Specifications Each hospital or healthcare facility can use up to 6 sets of AlarmView Systems, with 24 transmitters each, each set operating on its own channel.
AlarmView™ System User’s Guide Programmer Parameter Operating System Batteries (main) Rechargeable Battery Life Batteries (backup) Battery Operation Temperature Range (normal operation) Number of Beds Number of Transmitters Number of Pagers Setting Microsoft® Windows® CE 1 AAA NiMH (nickel metal-hydride) rechargeable battery pack 300 to 500 charge/discharge cycles 1 3V coin battery included Program up to 24 transmitters, 3 times a day for 1 week 23ºF to 112ºF (0ºC to 40ºC) Maximum 48 Maximum 24 Maximum 12
AlarmView™ System User’s Guide Altitude (normal operation) Water Resistance FCC Compliant 0 ft to 10,000 ft (0 m to 3,048 m) IEC 529 Class IPXI FCC Part 15 Electromagnetic Interference (EMI) AlarmView transmitter has been tested and found to comply with the limits for medical devices to the IEC 601-1-2:1993, EN 60601-1-2:1994, and Medical Device Directive 93/42/EEC. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation.
AlarmView™ System User’s Guide 6. Increase distance between interfering equipment and this equipment. 7. Manage use of frequencies close to AlarmView System frequencies. 8. Remove devices that are highly susceptible to EMI. 9. Lower power from internal sources within facility control (such as paging systems). 10. Label devices susceptible to EMI. 11. Educate clinical staff to recognize potential EMI-related problems. 12. Eliminate or reduce EMI with technical solutions (such as shielding). 13.
AlarmView™ System User’s Guide Section 3: Installation Setting Up Transmitter Before first use of a transmitter or transmitters in a care unit, perform a Transmitter Range Test (Per Section 5: Testing & Periodic Maintenance, “Transmitter Range Test: Survey Paging”). This will establish limits of unit coverage. Connect Antenna 1. Connect antenna to antenna connector on top of transmitter. For best transmission, antenna must be pointing up.
AlarmView™ System User’s Guide {Insert photo of power supply and AC power cord} Power Supply with Hospital-grade AC Power Cord ! Although transmitter can operate on its internal backup battery for a short period of time (up to 45 minutes under normal operation), always use AC power when possible. Do not connect transmitter to an electrical outlet controlled by a wall switch. If power is accidentally turned off, transmitter will run on backup battery.
AlarmView™ System User’s Guide ! A monitor that is not connected to AC power will not communicate with the transmitter – monitor data port is disabled when not connected to AC power – so the AlarmView System will not transmit in case of a monitor power failure. The only exception is the Nellcor N-395 monitor, which will continue to communicate with the transmitter while operating on battery power.
AlarmView™ System User’s Guide 2. Press On/Off button on top of transmitter. Indicators will flash on and off while transmitter performs a Power-On Self Test (POST) to check its function.
AlarmView™ System User’s Guide programming will be lost, and data will need to be reprogrammed into transmitter. 3. Mode LED is solid green when transmitter has established communication with monitor. Tx LED will flash green, and transmitter will send a Comm OK Page to assigned pager(s) to confirm communication between transmitter and monitor.
AlarmView™ System User’s Guide send Communication Failure pages to assigned pagers at periodic intervals for up to one hour. Operating Transmitter On Battery Power The transmitter has an internal, rechargeable backup battery. It can operate on battery power for approximately 45 minutes (under normal operation) if it becomes disconnected from AC power. The battery will automatically recharge when connected to AC power.
AlarmView™ System User’s Guide Section 4: Programming Using Programmer For basic operations of the AlarmView Programmer – including On/Off, adjusting contrast, backlight, setting date/time, and recharging or replacing main and backup batteries – refer to Appendix B: Basic Programmer Functions in the AlarmView System User’s Guide. ! Recharge the main battery pack often.
AlarmView™ System User’s Guide Tap Exit button {insert exit button} (< in upper left corner of screen) to return to SysMgr Main Screen from submenus. Tap Scroll buttons {insert scroll buttons} to move left and right to make tabs visible in submenus. Tap Down Arrow to reveal pull-down menu choices. Changing System Parameters AlarmView System parameters are set and transmitters are configured during to your specific site during initial system installation.
AlarmView™ System User’s Guide Changing System Password 1. Turn on programmer. Programmer will display SysMgr software main screen. {Insert SysMgr screen with start button noted (Figure 6-2)} Start Button 2. Tap Start button and tap AlarmView Install Program to select. Password screen with be displayed. {Insert password screen (Figure 6-3)} Password Screen 3. Tap Keyboard button to reveal Change Password button. {Insert change password screen (Figure 6-15)} Change Password Screen 4.
AlarmView™ System User’s Guide Changing Individual Transmitter Assignments Transmitter assignments will change as transmitters and monitors are moved to different beds, as transmitters are moved to different monitors in the care unit, as pagers are changed, and as caregivers are assigned to different patients. To view and change configuration of a transmitter, first retrieve the current parameters from the transmitter. Retrieving Transmitter Data To check current transmitter values: 1.
AlarmView™ System User’s Guide Aligning Infrared Ports ! ! The programmer must be within 4 feet (1.2 meters) of the transmitter and the infrared ports must be aimed directly at each other. 5. When retrieval of transmitter data is successful, programmer will display “Transmitter Data Loaded” status message and values will be displayed in data fields.
AlarmView™ System User’s Guide Changing Pager Assignments One, two, or all pagers can be assigned to each transmitter. To change alarm destination and pagers assigned to a transmitter: 1. From Alarms screen, tap button for Assigned Pager or All Pagers. 2. Tap Pagers tab to move to pager selection screen. {insert pager selection screenshot (Figure 6-6)} Pager Selection Screen 3. Tap Down Arrow in First Pager field and tap to select cap code for desired pager. 4.
AlarmView™ System User’s Guide 3. Press and hold transmitter On/Off button until an All Pagers confirmation message is received at pagers (approximately 5 seconds). Bed: 1234 Programming OK All Pagers Programming New Data into Transmitter Bed number and pager assignment changes made in the previous steps should now be programmed into the transmitter. ! ! Once data has been retrieved for a transmitter, it is easiest to change all values for that transmitter before sending changes back to transmitter. 1.
AlarmView™ System User’s Guide Changing Survey Page Configuration Prior to first use in a care unit, the effective range and coverage area of each transmitter should be tested by conducting a paging survey to ensure that the transmitter and pagers are performing as needed. The programmer can be used to set the time between pages and the total number of pages to be sent for performing survey paging (the default in 100 pages, sent every 15 seconds). To set interval between pages and total number of pages: 1.
AlarmView™ System User’s Guide 7. Wait for receipt of a “Programming OK” status message, then tap Exit button to return to SysMgr. The complete Survey Paging procedure is detailed in Section 5: Testing and Periodic Maintenance, “Transmitter Range Test,” in this manual. Changing Global System Parameters An AlarmView System is defined by a common transmission frequency and a pager Global Cap Code.
AlarmView™ System User’s Guide 5. Tap CHECK to retrieve current system configuration parameters. 6. a. To change sending frequency, tap Down Arrow in the MHz field. Sending frequency is frequency transmitted from transmitter to pager. b. To change baud rate, tap Down Arrow in the bps field. This programs transmitter baud rate to match pager receiving baud rate. c. To change Global Cap Code, tap All Pagers and use keyboard to type in new Global Cap Code. 7.
AlarmView™ System User’s Guide 4. Tap to select desired time interval from pull-down menu. 5. Aim programmer infrared port directly at infrared port on front of transmitter and tap SEND to program configuration changes into transmitter. A “Programming OK” message will be sent to pager(s) assigned to transmitter. 6. Repeat programming for every transmitter in system. 7. Tap Exit button to return to SysMgr.
AlarmView™ System User’s Guide Earth Leakage Current This test is in compliance with UL 2601-1 (earth leakage current). The applied voltage is 120 volts, 60 Hz for UL 2601-1 and CSA 601.1. Make all measurements with power switch in both the On and Off positions. 1. Connect transmitter power supply AC plug to electrical analyzer as recommended by analyzer operating instructions. 2. Connect transmitter power supply DC plug to transmitter DC input connector. 3.
AlarmView™ System User’s Guide Communications Page Each time a transmitter is turned on, or re-establishes communication with a monitor after having lost communication, the transmitter will automatically send a communications page (Comm OK Page) to all pager(s) assigned to the transmitter. After setting up transmitter (connecting it to power and to a monitor), to send a Comm OK Page test: 1. Check monitor to ensure it is on and functioning properly. 2. Press On/Off button on top of transmitter.
AlarmView™ System User’s Guide Test Page You should test the AlarmView System setup by conducting a Test Page when any changes affecting the system have occurred. To perform a Test Page, the transmitter must be on and communicating with the monitor. To send a test page: 1. Press On/Off button to turn transmitter on. Check to ensure that transmitter is communicating with monitor (both AC Indicator and Communications Indicator on transmitter are Green). 2. Turn on pager(s) assigned to transmitter. 3.
AlarmView™ System User’s Guide Transmitter Range Test (Survey Paging) Survey paging is used to determine the range and area of coverage of your system. An Transmitter Range Test (survey paging) will be performed at the time of initial system installation. Survey Paging should be conducted prior to first use of a transmitter added to a system, or when a transmitter has been moved to a new care unit.
AlarmView™ System User’s Guide range button}. Programmer will display “Survey Command Sent” status message and survey paging will begin. 4. Turn on pager(s) assigned to transmitter. Qualified personnel should be ready to walk the dimensions of the care unit. If you use more than one pager, keep them at least 4’ apart to avoid interference. 5. To start survey paging, aim programmer infrared port directly at port on front of transmitter and tap SVY button (in upper left corner of screen).
AlarmView™ System User’s Guide Turn on all transmitters, and ensure they are not communicating with monitors. When the transmitter you are testing sends a survey page, the other transmitters’ Mode LEDs should flash Amber. This should be seen at regular intervals as the survey page continues. If no dead spots are discovered and the transmitters can detect each other, the transmitter range test is complete. Contact Data Critical Corp. if dead spots present a problem in functioning of care unit.
AlarmView™ System User’s Guide To replace pager batteries, refer to Appendix A: Basic Pager Functions in AlarmView System User’s Guide. Cleaning Procedures When necessary, clean only the outer casing of the transmitter with a soft cloth, damp with a non-abrasive, commercial cleaner or 70% alcohol solution in water. Lightly wipe surfaces of transmitter. Use a clean cloth designed for lenses to clean the pager and programmer screens. Use a damp cloth to dust their casings, and wipe dry immediately.
AlarmView™ System User’s Guide Do not remove transmitter cover – there are no serviceable items inside. If any item or component of AlarmView System requires repair or service, contact Data Critical Corp.
AlarmView™ System User’s Guide Section 6: Troubleshooting Error Messages For common system problems, an AlarmView transmitter may send error messages to the pager(s) assigned to it. Below is a table of System Error Pages, along with probable causes, and recommended corrective actions.
AlarmView™ System User’s Guide reestablish communication. AC power. Comm Failure/Shutting Down Transmitter has not been able to communicate with the monitor for about an hour and is shutting down. Communications between transmitter and monitor have failed. Monitor is turned off or operating on battery power and transmitter is still on. Check monitor performance. Check serial cable and cable connections between transmitter and monitor. Reconnect or replace cable as required. Connect monitor to AC power.
AlarmView™ System User’s Guide Please be sure the transmitter is turned on, the IR port is pointed directly at the transmitter, at a distance less than 4 ft. (1.2 m) and try again. Programmer infrared port not aligned with transmitter infrared port. Re-align ports and try again. Transmitter turned off. Recharge programmer batteries. Programmer batteries are low. Transmitter defective. Programming Failed Programmer was unable to send programming changes to transmitter. Programmer defective.
AlarmView™ System User’s Guide If you are unable to resolve system problems using the above guides, contact Data Critical Corp. Technical Support for assistance. Getting System Information When speaking to a Data Critical Corp. representative, it may be necessary to access transmitter system information to troubleshoot problems. To obtain this information: 1. Turn on Programmer. 2. From SysMgr tap Start Button and tap Install Program. Install program password screen will be displayed. 3.
AlarmView™ System User’s Guide When speaking to a Data Critical Corp. representative, it may be necessary to refer to your programmer software version to troubleshoot problems. To obtain this information: 1. Turn on programmer. 2. Tap About button (About button reads AlarmView Wireless Data Notification System at the top of screen). The About screen will display. {Insert SysMgr screenshot with about button identified} About Button 3.
AlarmView™ System User’s Guide 3b Transmitter serial Cable, with 7-pin adapter for Nellcor N-3000 AlarmView Pager AlarmView Programmer Transmitter Power Supply and Hospital-grade AC power cord AlarmView System User’s Guide AlarmView Administrator’s Manual 4 5 6 7 8 {Insert diagram of spare parts with corresponding numbers} AlarmView System Replacement Parts Technical Support For technical advice, service, or information concerning any equipment in your AlarmView™ System, call Data Critical Corp.
AlarmView™ System User’s Guide Appendix A: Default Settings
AlarmView™ System User’s Guide Transmitter Parameter Global Cap Code Alarm Severity Reminder Interval Survey Page Interval Survey Page Duration Paging Baud Rate Paging Frequencies Bed Number Setting 0000021 Send All Alarms 60 seconds 15 seconds 100 pages 512 bps Parameter Global Cap Code Display Notification Mode Frequencies Setting 0000021 4 Lines Audible On Back Label of Pager Pager {insert part #} Appendix A-1
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