SOFTWARE VERSION 8.5 FAQs Capnostream 20p Bedside Capnography Monitor 2016 Software Version 8.5 Update Frequently Asked Questions and Answers 1. What items are affected as a part of this software update for Capnostream 20p monitors? The following items are affected on the Capnostream 20p monitor. Details on the visual are provided in the detail section of this document: a. Audio Alarm Volume OFF functionality b. USB File Size Download limits c. Alarm Storage and Trend availability d. Return to Home screen/operating mode functionality e. Unit for Pulse Rate now displayed f. Demo Mode indication on main screen added for better visualization g. Global Alarm Off icon display h. SpO 2 Signal Inadequacy icon i. Battery Status indication j. Upper and Lower Alarm Limits display added k. Improved, color-coded Integrated Pulmonary Index status visualization 2. Is Covidien recommending that I update all of my Capnostream 20p monitors? No. There is no need for you to proactively update your Capnostream 20p monitors. 3. How do I turn OFF the Audio Alarm Volume on the Capnostream 20p monitor? Please follow these steps to turn OFF the Audio Alarm Volume: SYSTEM-> SERVICE-> input service password-> INST DEFAULTS-> MONITOR. In the list of options on the screen, change the AUDIO ALARM VOLUME to AUDIO OFF. If you need additional assistance with this feature, please refer to the user manual, contact your sales representative, or contact Covidien Technical Service at 1-800-635-5267, option 1, then option 1, and option 1 again. IMPORTANT WARNING: Do not silence the audible alarms until you verify that the patient is being monitored by other means. 4. What was the ECRI device alert published January 26, 2015 on the Capnostream 20 and Capnostream 20p monitors? The ECRI device alert disclosed one reported customer complaint about an erroneous battery status indicator. The hospital reported that while preparing a patient for transport, the Capnostream monitor unexpectedly shut down after disconnection from AC power, despite the battery level indicator showing a fully charged battery prior to disconnection. 5. Was the ECRI device alert a safety issue? 1
No. This was a known software limitation of the Capnostream 20 and Capnostream 20p monitors. The devices are working as expected. 6. Does the Capnostream 20p bedside capnography monitor software update version 8.5 improve the design of the battery status indicator? Yes, the new software update will correctly display battery status on Capnostream 20p monitors. The battery status indicator will inform user of the presence/absence of a battery. Capnostream 20P monitor will display an "X" over the battery icon, when no battery is installed during monitor startup. NO BATTERY INSTALLED message will displayed in the Advisory Message area when no battery is installed The battery connect or disconnect must be done with the monitor turned off and disconnected from AC power for correct battery status indication. 7. How do I proactively upgrade my Capnostream 20p Bedside Capnography Monitors with the software version 8.5? If you would like to upgrade your Capnostream 20p monitors with software version 8.5 yourself, go to the web page www.medtronic.com/patientmonitoringsoftwareupgrades. From this web page, you can download 8.5 software to a Flash Memory Drive, and follow the instructions to install software version 8.5 on your Capnostream20p. Note that this software upgrade is intended only for Capnostream 20p monitors, not Capnostream 20 monitors. Detailed descriptions of the visual updates to the Capnostream 20p Bedside Capnography Monitor: a. Audio Alarm Volume OFF functionality To control audio alarm volume OFF or ON, the user is required to enter through the password restricted setup screen. When the audio alarm volume is set to OFF, the front panel silence key will deliver a wrong key beep when the key is pressed. b. USB file size splitting adjustment To accommodate fitting data into an Excel spreadsheet, downloaded files are split so that each file contains a maximum of 65,000 lines. File size splitting adjustment is applicable to all downloaded files except for binary files, which transfer real-time data directly to the USB (Full Continuous Transfer and Full Trend Transfer). c. Alarm Storage and Trend availability All alarms, including high (Urgent) and medium (Caution) priority are recorded and displayed. Caution alarms are represented in a yellow up/down arrow mark in the Tabular Trend screen. Caution alarms will be represented in yellow vertical lines in Graphical Trend screen. Present yellow cursor color is used in graphical trend, Tabular Trend, apnea and O 2 desat report screens. Cursor color will be changed to Light Lavender. d. Return to Home screen/soperating mode functionality All screens return to the Home screen/operating mode after time-out of one (1) minute. e. Unit for Pulse Rate is now displayed 2
Pulse Rate (PR) unit bpm is displayed continuously, similar to the etco 2 and SpO 2 units. Example: f. Addition of Demo Mode indicator Demo Mode text is now displayed in the main window, the text Demo Mode text flashes periodically. Example: g. Blinking of bell icon when Audio Alarm Volume is OFF During permanent alarm silence, the Audio Alarm Volume OFF icon (bell with solid cross) will blink every one (1) second. h. SpO 2 Signal Inadequacy icon display A Signal Inadequacy icon will be displayed when the SpO 2 signal is inadequate. 3
The new icon is displayed between the SpO 2 numeric value and the Nellcor SatSeconds label. Example: i. Battery Status indication During monitor start-up, a Battery Status indication update will correctly inform clinician about the presence or absence of a battery. The battery connect or disconnect must be done with the monitor turned off and disconnected from AC power for correct battery status indication. Capnostream 20p monitor will display a cross mark ("X") over the battery icon, when no battery is installed during monitor startup. The NO BATTERY INSTALLED message will display in the Advisory Message area if no battery is installed. Example: j. Alarm Limits Screen display 4
Upper and lower alarm limits for etco 2, SpO 2, and Integrated Pulmonary Index Algorithm (IPI) are now displayed. Example: k. Improved color-coded Integrated Pulmonary Index (IPI) status visualization: To provide a visual aid to the caregiver, the IPI value numeric on the screen is color coded, in traffic light colors, to reflects status: IPI values at and above the caution alarm limit display in green. Values below the caution alarm limit, but above or equal to the urgent alarm limit, display in yellow. Values below the urgent alarm limit display in red. The IPI number will flash, alternating between number color and background color. Example: COVIDIEN, COVIDIEN with logo and the Covidien logo are U.S. and internationally registered trademarks of Covidien AG. Other brands are trademarks of a Covidien company. 2016 Covidien. RE00017908C 5