HeartStart MRx Instructions for Use Addendum

Transcription

1 HeartStart MRx Instructions for Use Addendum For software Version 9.xx M3535A/M3536A HeartStart MRx

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3 Notice About This Edition Printed in the USA Publication number: The information in this document applies to the M3535A and M3536A HeartStart MRx. This information is subject to change without notice. Philips shall not be liable for errors contained herein or for incidental or consequential damages in connection with the furnishing, performance, or use of this material. Edition Print Date 1 July, 2007 Copyright Copyright 2007 Koninklijke Philips Electronics N.V. All rights are reserved. Permission is granted to copy and distribute this document for your organization s internal educational use. Reproduction and/or distribution outside your organization in whole or in part is prohibited without the prior written consent of the copyright holder. Rosetta-Lt, Rosetta-Rx and CAREpoint are trademarks of General Devices. Bluetooth wireless technology is a registered trademark of Bluetooth SIG, Inc. Steris Coverage Plus NPD is a registered trademark of Steris Corp. Q-CPR is a trademark of Laerdal Medical. CidexPlus is a registered trademark of Advanced Sterilization Products. Nellcor is a registered trademark of Nellcor Puritan Bennett, Inc. TransPac IV is a registered trademark of ICU Medical, Inc. TruWave is a registered trademark of Edwards Lifescience Corp. DTX Plus is a trademark of Becton, Dickinson & Co. Other trademarks and trade names are those of their respective owners. Use of supplies or accessories other than those recommended by Philips may compromise product performance. THIS PRODUCT IS NOT INTENDED FOR HOME USE. IN THE U.S., FEDERAL LAW RESTRICTS THIS DEVICE TO SALE ON OR BY THE ORDER OF A PHYSICIAN. Medical Device Directive The HeartStart MRx complies with the requirements of the Medical Device Directive 93/42/EEC and carries the 0123 mark accordingly. Manufacturer Philips Medical Systems 3000 Minuteman Road Andover, MA USA Authorized EU-representative Philips Medizin Systeme Böblingen GmbH Hewlett Packard Str Böblingen Germany For the Declaration of Conformity Statement, please see the Philips Medical web site at incenter.medical.philips.com/pmspublic. Scroll over the Quality and Regulatory Tab located in the upper left corner of the window. Click to select Regulatory by Modality. Then click to select Defibrillators and select the entry for Declaration of Conformity (DoC). Canada EMC:ICES-001 U.S. FCC and Industry Canada Radio Compliance: Contains FCC ID: PQC-WMTS-MODULE Operation of this equipment requires the prior coordination with a frequency coordinator designated by the FCC for the Wireless Medical Telemetry Service. This device complies with Part 15 of the FCC rules and RSS-210 of Industry Canada. Operation is subject to the following conditions: This device may not cause harmful interference. This device must accept any interference received, including interference that may cause undesired operation. Any changes or modifications to this equipment not expressly approved by Philips Medical Systems may cause harmful radio frequency interference and void your authority to operate this equipment. Warning Radio frequency (RF) interference coming from devices other than the HeartStart MRx may degrade the performance of the MRx. Electromagnetic compatibility with surrounding devices should be assessed prior to using the monitor/defibrillator. iii

4 This addendum to the Instructions for Use contain the following conventions: WARNING Warning statements describe conditions or actions that can result in personal injury or loss of life. CAUTION Caution statements describe conditions or actions that can result in damage to the equipment or loss of data. Notes contain additional information on usage. TEXT represents messages that appear on the display [Softkey] represents softkey labels that appear on the display above or below the button to which they correspond. Function keys: Menu Select button - Pressing the Menu Select button brings up the current menu or confirms a menu selection. Navigation buttons - The Navigation buttons display the current menu just as the Menu Select button does. Additionally, within any menu or list, these buttons move to the next or previous item on the list. They also increase or decrease numbers or values in a sequence. Images of the HeartStart MRx display and menus appearing in this document are for illustration purposes only. Menu choices on your device are driven by the options you have and selections you make in Configuration Mode. iv

5 1Table of Contents Introduction Lead Acute MI Warning Statements... 2 Configuring Acute MI Statements... 2 Generating the Acute MI message... 3 Transmitting Data... 4 Preparing for Transmission Lead Transmission, Rosetta-Lt... 7 Connecting the Devices... 8 Transmitting Data in Data Management Mode... 9 Transmitting Data in 12-Lead Mode Tracking Data Transmission Transmission Errors Cancelling a Transmission Queuing Transmissions Finding Transmission Results Copy and Print Printing Copying Latching Alarms Pacer Output Yellow Alarm External Paddles Cleaning Event Summary Modification Environmental Specifications Bluetooth Specifications Configuration Modifications Parameter Block Numerics Supplies and Accessories v

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7 Introduction Thank you for choosing the HeartStart MRx monitor/defibrillator. Software Version 9.xx extends the HeartStart MRx s monitoring, resuscitation and data management functionality. This document is an addendum to the HeartStart MRx Instructions for Use. It explains how to use the new features of the HeartStart MRx running software Version 9.xx including: 12-Lead Simplified Acute MI Statements. If configured On, a simple ACUTE MI warning statement appears on the 12-Lead Report screen to quickly catch your attention that the 12-Lead Algorithm has detected an acute MI. See 12-Lead Acute MI Warning Statements on page 2. The Rosetta-Lt transmission device. Two-way radio is added to the suite of HeartStart MRx transmission options (available in the United States only). You can transmit 12-Lead Reports to a healthcare facility using the Rosetta-Lt. See 12-Lead Transmission, Rosetta-Lt on page 7. Event Summary, Bluetooth wireless data transmission. You can transmit an Event Summary via Bluetooth to an external computer. See Transmitting Data in Data Management Mode on page 9. Q-CPR configuration. You can configure Q-CPR to be On or Off at startup. See Configuration Modifications on page 18. Parameter Block Numbers. Noninvasive blood pressure numerics in Parameter Block 1 are larger when temperature numerics are not displayed. Invasive pressure numerics in Parameter Block 2 are larger when EtCO 2 numerics are not displayed. See Parameter Block Numerics on page 19. Copy and Print individual 12-Lead Reports from Data Management Mode. You can copy and print individual 12-Lead Reports from Data Management Mode. See Copy and Print on page 14. Latching Alarms Modification. A modification to latching alarms, introduced with Version 8.xx software. For more information, see Latching Alarms on page 16. With this addendum, the HeartStart MRx Instructions for Use, labeled for use with software version 7, can also be used with devices running version 8.xx or 9.xx software. Keep this addendum with your HeartStart MRx Instructions for Use. 1

8 12-Lead Acute MI Warning Statements 12-Lead Acute MI Warning Statements To aid in quickly identifying an acute myocardial infarction, the HeartStart MRx displays a simple ACUTE MI warning statement on the 12-Lead Report screen when the Philips 12-Lead Algorithm detects an acute MI. See Figure 1. The 12-Lead Algorithm uses measurements and patient information (age, gender, paced status) to generate interpretive statements describing the patient s cardiac rhythm and waveform morphology. Figure 1 Acute MI Indication Aug :19:00 55 years Male HR 60 SINUS RHYTHM PR 168 CONSIDER RIGHT ATRIAL ABNORMALITY QRSD 74 INFERIOR INJURY, PROBABLE EARY ACUTE INFARCT QT 360 ANT-SEPT INJURY, PROBABLE EARLY ACUTE INFARCT QTc 360 LATERAL LEADS ARE ALSO INVOLVED --Axis-- P 52 QRS 45 T 41 -ABNORMAL ECG- Unconfirmed diagnosis >>>> ACUTE MI <<<< Start NBP Exit 12-Lead New 12-Lead Print MENU The simplified ACUTE MI warning statement also appears on the 12-Lead Report printed by the HeartStart MRx. It does not appear on 12-Lead Reports transmitted to a healthcare facility. For more information about 12-Lead ECG and the 12-Lead Report see the 12-Lead ECG chapter in the HeartStart MRx Instructions for Use. For a list of interpretive statements and their acceptance criteria, see Acute MI Warning Statements on page 3. Configuring Acute MI Statements You can enable/disable acute MI statement display and printing in Configuration Mode s 12-Lead Configuration Screen. See Table 1 for the added configuration option. For a complete list of HeartStart MRx configurable parameters and how to access Configuration Mode, see the Configuration chapter of the HeartStart MRx Instructions for Use. Table 1 Acute MI Statement Configuration Parameter Description Setting Choices (Default in bold) Acute MI Indication Defines whether the ACUTE MI simplified statement appears on the 12-Lead display and is printed on the 12-Lead Report. Yes, No 2

9 12-Lead Acute MI Warning Statements Generating the Acute MI message Table 2 lists the 24 interpretive statements that generate an ACUTE MI message. Table 2 Acute MI Warning Statements Description Criteria PROBABLE ANTEROLATERAL INFARCT, ACUTE ST >0.15 mv, Q >30 ms, V2-V5 ANTEROLATERAL INFARCT, ACUTE Q >35 ms, ST >0.20 mv, V2-V6 ANTEROLATERAL INJURY, EARLY ACUTE INFARCT ST >0.15 mv, I avl V2-V6 PROBABLE ANTEROSEPTAL INFARCT, ACUTE Q >30 ms, ST>0.15 mv, V1-V3 ANT-SEPT INJURY, PROBABLE EARLY ACUTE INFARCT ST >0.40 mv V1-V3 ANTERIOR INFARCT, ACUTE Q >30 ms, ST >0.25 mv, V1-V4 ANTERIOR INFARCT, ACUTE ST >0.25 mv, T neg, V1-V5 ANTERIOR INJURY, EARLY ACUTE INFARCT ST >0.35 mv in V1-V5 ANTEROSEPTAL INFARCT, ACUTE Q >30 ms, ST >0.25 mv, V1-V3 EXTENSIVE ANTERIOR INFARCT, ACUTE Q >35 ms, ST >0.15 mv, V1-V6 PROBABLE INFERIOR INFARCT, ACUTE Q>25 ms, ST>0.10 mv, II III avf INFERIOR INFARCT, POSSIBLY ACUTE Q >35 ms, ST >0.10 mv, II III avf INFERIOR INFARCT, ACUTE Q>35 ms, ST>0.07 mv, T neg, II-aVF INFERIOR INJURY, PROBABLE EARLY ACUTE INFARCT ST>0.15 mv, II III avf INFEROPOSTERIOR INFARCT, ACUTE ST >.10 II III avf, <-.05 V1-V4 PROBABLE LATERAL INFARCT, ACUTE Q >25 ms, ST>0.10 mv, I avl V5 V6 LATERAL INFARCT, ACUTE ST >.20 mv, Q >35 ms, I avl V5 V6 LATERAL INJURY, PROBABLE EARLY ACUTE INFARCT ST >0.10 mv, I avl V5 V6 ST ELEVATION, PROBABLE ANTERIOR INJURY ST >0.25 mv in V1-V5 ST ELEVATION, PROBABLE ANTEROLATERAL INJURY ST >0.15 mv, I avl V2-V6 ST ELEVATION, PROBABLE INFERIOR INJURY inf ST>0.1 mv, lat ST<-0.05 mv ST ELEVATION, PROBABLE LATERAL INJURY ST >0.08 mv, I avl V5 V6 POSTERIOR INFARCT, ACUTE prominent R T, ST <-.05 V1-V4 PROBABLE POSTERIOR INFARCT, ACUTE prominent R T, ST <-.05 V1-V3 3

10 Transmitting Data Transmitting Data Software version 9.xx extends the HeartStart MRx s suite of data transmission options. See Transmission Use Cases on page 6 for examples. You can configure up to 20 Bluetooth transmission devices. In addition to the transmission options listed in the HeartStart MRx Instructions for Use, you can: Transmit a 12-Lead Report via the Rosetta-Lt - The HeartStart MRx uses the Rosetta-Lt with a cable plugged into the RS-232 port to transmit a 12-Lead Report from the 12-Lead screen (during clinical use) or Data Management Mode (after clinical use) to the Rosetta-Lt for your eventual transmission to a healthcare facility. See Figure 2 and 12-Lead Transmission, Rosetta-Lt on page 7. Figure 2 Transmission via the Rosetta-Lt University Hospital Children's Hospital PLACE MIC ON PAD POWER START STOP Tx/Rx Rosetta - Lt Data Translator GENERA DEVICES HeartStart MRx Rosetta-Lt 2-Way Radio Radio Tower Receiving device at a healthcare facility Transmit an Event Summary to an external computer - The HeartStart MRx uses Bluetooth wireless technology to transmit an Event Summary from Data Management Mode to a nearby personal computer/laptop/tablet/mobile device after clinical use. See Figure 3 and Transmitting Data in Data Management Mode on page 9. Transmit a 12-Lead Report to an external computer - The HeartStart MRx uses Bluetooth wireless technology to transmit a 12-Lead Report from the 12-Lead screen (during clinical use) or Data Management Mode (after clinical use) to a nearby Bluetooth-enabled personal computer/laptop/ tablet/mobile device. See Figure 3, Transmitting Data in Data Management Mode on page 9 and Transmitting Data in 12-Lead Mode on page 10. Figure 3 Transmitting to an External Computer HeartStart MRx Personal Computer/ Laptop/ Tablet/ Mobile Device 4

11 Transmitting Data Preparing for Transmission Before transmitting data, the HeartStart MRx needs to be set up properly and, if you are using Bluetooth wireless technology, the wireless devices need to be set up. See the 12-Lead ECG Transmission chapter in the HeartStart Instructions for Use for more information on configuring sites and adding Bluetooth devices. CAUTION The process for adding a Bluetooth device for a telephone transmission (documented in the Instructions for Use) differs slightly than adding a Bluetooth device for the Event Summary, Bluetooth option. You will not be prompted to select a profile when adding a Bluetooth device as part of the Event Summary, Bluetooth option. After completing the transmission test, return to this document for instructions on how to transmit data. The HeartStart MRx is capable of communicating via Bluetooth with nearby devices such as computers, laptops, tablets and mobile devices. Each of these devices has a unique set of features and configuration options. In order to ensure reliable transmissions, familiarize yourself with the Bluetooth configuration choices of each. Some choices (either default or chosen by the user) could prevent receipt of data from the HeartStart MRx. For example, it is recommended that you disable features such as Start discovery every 10 minutes. Enabling this option could interfere with transmissions from the HeartStart MRx. The process for setting up a Bluetooth wireless transmission device in Version 9.xx software may have one additional step. After the pairing process is complete, you are prompted to select a Bluetooth Service. Highlight File Transfer or Dial-Up Networking and press the Menu Select button. If you are unsure of which service to select, contact your Philips installation manager for more information. 5

12 Transmitting Data I want to transmit: Table 3 An Event Summary to an external computer wirelessly 1. A 12-Lead ECG using the RS-232 port, a cell phone and the Internet to a destination point. 2 A 12-Lead ECG using Bluetooth wireless technology via a cell phone, land line modem or other cellular broadband gateway to the Internet. A 12-Lead ECG using a 2-way radio and the Rosetta-Lt to a CAREpoint or Rosetta-Rx device at a healthcare facility 3. A 12-Lead ECG using electronic PCR software in my portable computer 4. Transmission Use Cases The HeartStart MRx uses: Bluetooth wireless technology to transmit data to a Bluetoothenabled computer. The RS-232 port to transmit data through a cell phone to a selected destination. Dial Up Networking (DUN) and a Bluetooth wireless card to transmit a 12- Lead ECG through a cell phone, land line modem or other gateway to a destination point. An RS-232 cable 5 to connect the HeartStart MRx to the Rosetta-Lt, which then transmits to a destination point. Bluetooth File Transfer and a Bluetooth wireless card to transmit the 12-Lead ECG to the PC. What transmission options does my HeartStart MRx need to make it work? The Event Summary Bluetooth option (B10) OR product upgrades (Event Summary, Bluetooth) and (Internal Bluetooth Card). The 12-Lead Transmission - RS-232 and Bluetooth option (B07) OR product upgrades M3802 (12-Lead BT/RS-232 Transmit) and (Internal Bluetooth Card). The 12-Lead Transmission - Bluetooth wireless technology option (B06) OR product upgrades M3801 (12-Lead BT Transmit) and (Internal Bluetooth Card). The 12-Lead Transmission, Rosetta-Lt interface option (B11) OR product upgrade (12-Lead transmission, Rosetta- Lt Interface). The Event Summary Bluetooth option (B10) AND one of the 12-Lead Transmission options (Serial, Bluetooth or Rosetta-Lt) installed. Where do I find instructions? See Transmitting Data in Data Management Mode on page 9. See the 12-Lead Transmission chapter in the HeartStart MRx Instructions for Use. See Transmitting Data in Data Management Mode on page 9 and/or Transmitting Data in 12-Lead Mode on page 10. See 12-Lead Transmission, Rosetta-Lt on page 7. See Transmitting Data in Data Management Mode on page 9 and/or Transmitting Data in 12-Lead Mode on page 10. : Combining various options allows you the flexibility of multiple transmission avenues. Functionality remains the same with added options. All options work together, however the Rosetta-Lt option can t be used at the same time as the RS-232 port option or the IntelliVue Networking backpack. All three use the same physical connection to the HeartStart MRx. 1 Windows-based personal computer/laptop/tablet/mobile device with a Bluetooth stack installed that supports File Transfer Profile Server. See Bluetooth Specifications on page 17 for more information. 2 There are a limited number of carriers and cellphones which support this feature. Consult your Philips Sales Representative for more information. 3 Available in the U.S. only. 4 Patient Care Report (PCR) software must be able to deliver the file to the healthcare facility. The destination site set at the HeartStart MRx is contained in the file information transmitted. If you use a Philips product to deliver the file to the healthcare facility, it reads the destination site from the file sent. For more information on the set-up of your epcr software, see the software s Instructions for Use. 5 Cable provided by General Devices. For more information concerning the setup and configuration of transmission devices and the HeartStart MRx, see the latest version of the Philips 12-Lead Transmission Implementation Guide and the HeartStart MRx Instructions for Use. 6

13 Transmitting Data 12-Lead Transmission, Rosetta-Lt With Version 9.xx software, the HeartStart MRx enables you to transmit a 12-Lead Report to a Rosetta-Lt for two-way radio transmission to a healthcare facility running CAREpoint or Rosetta-Rx. WARNING Do not connect the HeartStart MRx to the Rosetta-Lt when the Rosetta-Lt is connected to a telephone line. This combination is prohibited. Before connecting the Rosetta-Lt to a telephone line, disconnect it from the HeartStart MRx. The 12-Lead Report sent to the Rosetta-Lt includes: Patient identification information Device identification information Event ID number Waveform data Optional information in the 12-Lead Report includes: Measurements. The 12-Lead Report can also contain numerics for vital signs (SpO 2, EtCO 2, AwRR, Pulse, Temp, Invasive Pressure, NBP) if available. The vitals sent with the report are the values recorded at the beginning of the 12-Lead acquisition. If a vital numeric is unavailable or its source is off, then the vital numeric is not included in the report. NBP numerics are valid for 60 minutes. If no measurement has been taken in the last 60 minutes, NBP numerics are considered unavailable. NBP numerics include the measurement time. Statements Rhythm strips CAUTION The HeartStart MRx sends the above data to the Rosetta-Lt. Information displayed on the 12-Lead Report produced by the Rosetta-Lt is determined by Rosetta-Lt software. A 12-Lead Report sent to the Rosetta-Lt will overwrite any 12-Lead Report which currently exists on the Rosetta-Lt. It is your responsibility to forward the 12-Lead Report from the Rosetta-Lt to its destination. See the Rosetta-Lt User s Guide for more information. If your HeartStart MRx is transmitting a 12-Lead Report via means other than the Rosetta-Lt, the Rosetta-Lt option is disabled in the Send to menu until the transmission is complete. 7

14 Transmitting Data Connecting the Devices To connect the Rosetta-Lt to the HeartStart MRx, insert the Rosetta-Lt cable into the HeartStart MRx s RS-232 Serial port and tighten the screws. See Figure 4. Figure 4 Attaching the Rosetta-Lt to the HeartStart MRx PLACEMICON PAD START STOP POWER Tx/Rx Rosetta-Lt Data Translator GENERAL DEVICES For questions about the Rosetta-Lt and connector cable or to purchase a connector cable/additional items, contact General Devices. See the Rosetta-Lt Data Translator User s Manual for more information. See Transmitting Data in Data Management Mode on page 9 and Transmitting Data in 12-Lead Mode on page 10 for details on how to send 12-Lead Reports using the HeartStart MRx and the Rosetta-Lt. 8

15 Transmitting Data Transmitting Data in Data Management Mode The HeartStart MRx Event Summary, Bluetooth option uses Bluetooth wireless technology to send an Event Summary (complete or partial) or a 12-Lead Report to a receiving Bluetooth device from Data Management Mode. The Rosetta-Lt transmission device uses two-way radio to transmit 12-Lead Reports from Data Management Mode. Transmitted Event Summaries include all stored waves, trending data, 12-Lead Reports and event files, including vital signs such as heart rate, pulse, SpO 2, EtCO 2, AwRR, NBP, invasive pressure and temperature numerics. If your HeartStart MRx has the Audio and/or Q-CPR Data options, you can include these parts of the Event Summary. Event Summaries can only be transferred to devices that support the Bluetooth File Transfer Profile Server. To transmit an Event Summary or 12-Lead Report from the HeartStart MRx s internal memory to a receiving device, perform the following: 1 After you have finished monitoring the patient and removed them from the HeartStart MRx, place the device into Data Management Mode. The display reads Data Management - Internal Memory across the top. 2 Using the [Prev Item] and [Next Item] softkeys, highlight the Event Summary you want to transmit (or the Event Summary which contains the 12-Lead Report you want to transmit) and press the Menu Select button. 3 Highlight Send and press the Menu Select button. 4 Highlight the type of data you want to transmit (see Figure 5) and press the Menu Select button. Send All Event Data Exclude Audio & Q-CPR 1-25 Apr : Apr :30 Exit Figure 5 Send Functions Highlight All Event Data to send an entire event, including 12-Lead Reports. Text in this menu line varies depending upon the HeartStart MRx options installed: Exclude Audio & Q-CPR is displayed if your device has the Audio Recording, Q- CPR Data and Event Summary, Bluetooth options. Exclude Audio is displayed if your device has the Audio Recording and Event Summary, Bluetooth options and does not have the Q-CPR Data option. Exclude Q-CPR is displayed if your device has the Q-CPR Data and Event Summary, Bluetooth options and does not have the Audio Recording option. Highlight the specific data to exclude it from the Event Summary transmission. If you only want to transmit a specific 12-Lead Report, highlight it to transmit. Highlight Exit to exit the Send menu without transmitting any data. 5 Depending upon which option you selected in Step 4, you are presented with different menus. If you selected a 12-Lead Report: 1 Select a destination for the 12-Lead Report from the Send To menu. Highlight the destination and press the Menu Select button. If your device is configured with just one transmission device or you selected the Rosetta-Lt, transmission begins. 2 If your device has more than one configured transmission device, highlight the transmission device you want to use and press the Menu Select button. Transmission begins. See Figure 6. If you are using the Rosetta-Lt option to transmit 12-Lead Reports, see 12-Lead Transmission, Rosetta-Lt on page 7 for more information. 9

16 Transmitting Data Figure 6 Send All Events Data Exclude Audio & Q-CPR 1-25 Apr : Apr :30 Exit Steps to Sending 12-Leads Send To Rosetta St. Mary's ED St. Joseph s Cath Lab Dr. Smith Dr. Jones EMS Station Fax Number Exit Transmission Devices 1st Configured Device 2nd Configured Device nth Configured Device 20th Configured Device If you selected an Event Summary: If your device is configured with just one transmission device, transmission begins. If your device has more than one configured transmission device, highlight the option you want to use and press the Menu Select button. Transmission begins. See Figure 7. Figure 7 Event Summary Transmission Transmission Devices 1st Configured Device 2nd Configured Device 3rd Configured Device 4th Configured Device If you press the Exit Data Management softkey while a transmission is ongoing, you need to confirm your selection. Selecting Yes exits Data Management, cancels your current transmission and any queued transmissions. Selecting No continues the current transmission. If you print an event in Clinical Mode and switch to Data Management Mode, the printing must be complete before the event can be copied or sent. Failure to do so results in either a Cannot copy this event while printing or a Cannot send this event while printing message. If you get either message, wait for the printing to finish or cancel the printing before proceeding. Transmitting Data in 12-Lead Mode You can transmit a 12-Lead Report while monitoring a patient in 12-Lead Mode. To send the current 12-Lead Report: 1 From the 12-Lead Report screen, press the Menu Select button. 2 Select Send and press the Menu Select button. 3 Select the destination of the 12-Lead from the Send To menu and press the Menu Select button. 4 If your device is configured with just one option to transmit the 12-Lead Report or you selected the Rosetta-Lt, transmission begins when you press the Menu Select button. If your device has more than one configured transmission device, highlight the device you want to use and press the Menu Select button. Transmission begins. See Figure 6. S The HeartStart MRx transmits data from internal memory only. Data contained on the external data card only is not transmittable. If you are using the Rosetta-Lt option to transmit 12-Lead Reports, see 12-Lead Transmission, Rosetta-Lt on page 7 for more information. 10

17 Transmitting Data Tracking Data Transmission After initiating a data transmission from the HeartStart MRx, you can track transmission progress on the device display. For events, the event ID along with the date and time of the event data being sent are displayed while for 12-Lead Reports, the date and time of the report are displayed. The phase progress (Connecting to Device and Sending) is also shown. If the HeartStart MRx is in the process of sending data, a percentage complete is also displayed. See Figure 8. Figure 8 Transmission Progress Screen 25 Jan :52 Sending, 40 % complete Once transmission is complete, a brief Confirming. Stand by... message appears on the display followed by a Disconnecting message. Then the transmission progress message is removed. If a 12-Lead transmission occurs during a patient incident, an event indicating the time of transmission is logged into the current Event Summary. If you exit the Data Management screen or leave a clinical mode causing a reboot of the device during transmission, the transmission is aborted. Changing between clinical views (AED, Monitoring, Pacing, Manual Defibrillation) does not terminate a transmission. Transmission Errors If there is an error in transmission, a message is displayed on the HeartStart MRx screen, accompanied by an audio beep. Press the Menu Select button to acknowledge the error. See Figure 9. The error is logged into the Device Status Log. See Table 4 for new possible transmission errors. See the HeartStart MRx Instructions for Use Troubleshooting chapter for a full list of transmission errors. Figure 9 Transmission Failure Mark Event 10 Feb :20 Jones, Samuel Adult Non-Paced 02:42 HR Temp C Pulse bpm NBP mmhg q120 bpm SYS : II Transmission Failed Connection Failed 120/80 (95) Pleth SpO2 % 100 EtCO2 mmhg AwRR rpm PACING ON BATTERIES Demand Mode 70 ppm 50 ma Start NBP Resume Pacing Pacer Rate Pacer Output Acknowledge 11

18 Transmitting Data Table 4 Transmission Errors Message on HeartStart MRx screen Reason Possible solution No transmission device detected The HeartStart MRx failed If using the Rosetta-Lt: to connect to the selected transmission device. Check cables and connections. Replace Rosetta-Lt battery. If using Bluetooth: Move the HeartStart MRx closer to the external computer and re-transmit. Transmission Failed If using the Rosetta-Lt: The 12-Lead Report was not Check cables and connections. transmitted to the Rosetta- Lt. Replace Rosetta-Lt battery. Transmission Failed If using the Rosetta-Lt: Timeout The transfer did not Check cables and connections. complete within the 1-minute timeout period. Replace Rosetta-Lt battery. Transmission Failed. Connection Failed. Transmission Failed. Connection Interrupted. Cancelling a Transmission A Bluetooth Card malfunction occurred. An error occurred during transmission of one of the files. Receiving device is full. User settings in the Bluetooth device do not allow transmission To cancel a transmission in progress, perform the following: 1 From either 12-Lead Mode or Data Management Mode, press the Menu Select button. 2 Highlight Cancel Transmission and press the Menu Select button. Retry transmission. Check permissions on FTP device configurations. permissions must allow for reading and writing. Reset receiving device and retransmit. Check available space on receiving device. Set Bluetooth device to allow all operations for the HeartStart MRx and retransmit. 3 Confirm the Cancel Transmission action. Highlight Yes and press the Menu Select button to cancel; highlight No and press the Menu Select button to continue the transmission. After confirming a transmission cancellation, the HeartStart MRx displays a Disconnecting message until the cancel process is completed. Some disconnections may occur so quickly that the Disconnecting message may not be visible. 12

19 Transmitting Data Queuing Transmissions With Version 9.xx software you can queue more than one HeartStart MRx 12-Lead Report or Event Summary for transmission using the same transmission device (except the Rosetta-Lt). 12-Lead Reports can be queued to the same or different locations. If you are using the Rosetta-Lt you must complete the transmission from the HeartStart MRx to the Rosetta-Lt AND from the Rosetta-Lt to its communication device before beginning another transmission. Failure to do so results in overwriting the first transmission to the Rosetta-Lt with the second transmission. To queue another transmission while a transmission is in progress, follow the same steps you used to send the first transmission except you are not asked to select a transmission device. Your data is sent following completion of the transmission in progress. When you attempt to queue a transmission, items listed in the Send Menu which are incompatible with the current connection are unavailable and grayed out. To transmit using different transmission devices, you must complete the first transmission before initiating the next one. When a transmission fails or you cancel a transmission, any queued transmissions are cancelled and no events are logged. Finding Transmission Results When data is transmitted from the HeartStart MRx via Bluetooth File Transfer to a receiving device, it is placed in the default folder (typically located at: My Documents/Bluetooth Exchange Folder) set-up during Bluetooth configuration of the receiving device. The HeartStart MRx creates a philipsmrx folder and, depending on the data sent, a sub-folder: 12-Leads or events. The events folder contains all event data sent, including any 12-Leads sent as part of the event. Independently sent 12- Leads are contained in the 12-Leads folder. Event Summaries and 12-Lead Reports could contain information which could be considered Patient Healthcare Information (PHI) or patient identifiable data. This information can be printed or transferred from the HeartStart MRx. Please handle in accordance with HIPAA or your local patient privacy requirements. 13

20 Copy and Print Copy and Print With Version 9.xx software, you can copy and print individual 12-Lead Reports (along with Event Summaries and trending data) from Data Management Mode. Printing To print in Data Management Mode, perform the following: 1 While in Data Management Mode, use the [Prev] and [Next] softkeys to highlight the Event Summary which contains the data you want to print and press the Menu Select button. 2 Highlight Print and press the Menu Select button. 3 Select the data option listed that you want to print (see Figure 10) and press the Menu Select button to print. Figure 10 Printing in Data Management Mode Print Event Summary Trends 1-25 Apr : Apr :30 Exit Highlight Event Summary to print the selected Event Summary. Highlight Trends to bring up the Trends Interval screen and print the current Trends Report. Highlight the specific 12-Lead Report you want to print. Highlight Exit to exit the Print menu. 14

21 Copy and Print Copying To copy to the external data card in Data Management Mode, perform the following: 1 While in Data Management Mode, use the [Prev] and [Next] softkeys to highlight the Event Summary which contains the data you want to copy and press the Menu Select button. 2 Highlight Copy and press the Menu Select button. 3 Select the data option listed that you want to copy (see Figure 11) and press the Menu Select button to copy to the external data card. Figure 11 Copying in Data Management Mode Copy All Event Data 1-25 Apr : Apr :30 Exit Highlight All Event Data to copy the selected Event Summary. Highlight the specific 12-Lead Report listed to copy the selected 12-Lead Report. Highlight Exit to exit the Copy menu. If you print an event in Clinical Mode and switch to Data Management Mode, the printing must be complete before the event can be copied or sent. Failure to do so results in either a Cannot copy this event while printing or a Cannot send this event while printing message. If you get either message, wait for the printing to finish or cancel the printing before proceeding. 15

22 Latching Alarms Latching Alarms In software versions 8.xx and 9.xx, the following red alarms are latching alarms: Desat Apnea ABP, ART, Ao, PAP, P1 or P2 Disconnect The HeartStart MRx Instructions for Use labeled for use with software version 7 (identified on the book s back cover) lists these three alarms as non-latching. See Chapter 8, Pulse Oximetry - SpO 2 Alarms for Desat references; Chapter 10, Monitoring Carbon Dioxide - EtCO 2 and AwRR Alarms for Apnea references; and Chapter 11, Invasive Pressure - Alarms for Disconnect references. Latching alarms remain present regardless if the alarm condition continues to exist or not. A latching alarm is not removed until it is either acknowledged or a higher priority alarm condition for the same measurement occurs. To determine the software version running on your HeartStart MRx: 1 Turn the HeartStart MRx on and press the Menu Select button. 2 Select Other and press the Menu Select button. 3 Select Print Device Info and press the Menu Select button. The device software version will appear on the printout. If your healthcare facility has a mixed fleet of HeartStart MRx devices, please consider a method of identifying the HeartStart MRx devices with software version <7.00 code - non-latching red alarms for Desat, Apnea and ABP, ART, Ao, PAP, P1 or P2 Disconnect. Pacer Output Yellow Alarm When providing noninvasive pacing with the HeartStart MRx, if the pacer output drops below the selected setting by 20 percent or 10mA (whichever is greater), a Pacer Output Low yellow alarm is displayed on the top line of the Pacer Status block. The alarm will remain on the display until pacing is stopped, the condition clears or the therapy knob is moved off the Pacer position. A Pacer Output Low entry is logged in the Event Summary. 16

23 External Paddles Cleaning External Paddles Cleaning If external non-sterilizable paddles were used during defibrillation, make sure you thoroughly clean the paddles and paddle tray after each patient event and before performing an Operational Check or Weekly Shock Test. Verify that there is no debris or residue (including all conductive material) on the electrode surfaces of the paddles and paddle tray. External non-sterilizable paddles may be cleaned with a soft cloth moistened with: Mild soap and water. 3.4% gluteraldehyde solution such as CidexPlus Sodium hypochlorite (chlorine bleach) (3% solution in water). Quaternary ammonium compounds (21% quaternary ammonium content, such as Steris Coverage Plus NPD ), (.5 oz. per gallon water - one part Coverage Plus NPD to 255 parts water). Isopropyl alcohol (70% solution in water). CAUTION The paddles may not be ultrasonically cleaned or immersed. Also, they can t be autoclaved or ETO sterilized. Event Summary Modification With version 9.xx software, a snapshot of vital signs for heart rate, SpO 2, EtCO 2, AwRR, pulse, temperature and invasive pressure are logged to the Event Summary each five minutes after the parameter is turned on. NBP measurements are logged every time a measurement is taken. These values are independent of the values stored in the Trends table. Environmental Specifications Safety: The HeartStart M3535A and HeartStart M3536A meet UL , CSA C22.2 No , EN and standards. Recycling: This product consists of devices that may contain mercury, which must be recycled or disposed of in accordance with local, state or federal laws. (Within this system, the backlight lamps in the monitor display contain mercury.) Bluetooth Specifications The HeartStart MRx supports File Transfer Profile Server 1.1 and was tested with the following Bluetooth stacks: Toshiba , IVT (Product)/ (stack) and Widcomm For other Bluetooth stacks, review your user documentation to see if File Transfer Profile Server 1.1 is supported. If not, it is recommended that you install drivers that support File Transfer Profile Server

24 Configuration Modifications Configuration Modifications Table 5 contains a documentation modification for the upper limit of Pacing Output in Configuration Mode, found in the Manual Therapy Settings Configuration listing. The upper limit in Clinical Mode remains 175mA. Table 5 Manual Therapy Settings Parameter Description Setting Choices Pacing Output Upon entering the selected Pacer Mode (Demand or Fixed), defines the default current setting at which paced pulses are delivered , 30 (ma) adjusted in increments of 5 Table 6 contains a new configuration option for Q-CPR. It is found in the Q-CPR Settings listing in Configuration Mode. Table 6 Q-CPR Setting Parameter Description Setting Choices Q-CPR In devices with the Q-CPR option, this setting defines whether Q-CPR is configured to be off or on. On, Off WARNING For a complete list of HeartStart MRx configurable parameters and how to access Configuration Mode, see the Configuration Chapter in the HeartStart MRx Instructions for Use. The HeartStart MRx should never be connected to a patient while performing configuration activities. 18

25 Parameter Block Numerics Parameter Block Numerics With Version 9.xx software, noninvasive blood pressure numerics in Parameter Block 1 adjust in size based on the presence of temperature numerics. Invasive pressure numerics in Parameter Block 2 adjust in size based on the presence of EtCO 2 numerics. See Figure 12. Figure 12 Parameter Block Numerics Parameter Block 1 with temperature, pulse and NBP HR bpm o Temp C Pulse bpm NBP mmhg Manual SYS 11: /69 (86) 90 Parameter Block 1 with pulse and NBP HR bpm Pulse bpm NBP mmhg Manual 119/69 (93) 14:45 SYS Parameter Block 2 with invasive pressure and EtCO 2 Parameter Block 2 with invasive pressure and no EtCO 2 ABP 119/79 (95) mmhg PAP mmhg Sp02 % EtCO2 mmhg AwRR rpm SYS /10 (15) DIA ABP mmhg PAP mmhg Sp02 % SYS DIA /79 (95) 16 25/10 (15)

26 Supplies and Accessories Supplies and Accessories The HeartStart MRx has added supplies and accessories which can be used with your device. See Table 7. Table 7 Additional Supplies and Accessories 12-Lead ECG Cable Set M1663A 10-Lead ECG Patient Trunk Cable, 12-pin ECG Input Connector (for 5-Lead and 12-Lead use) 3-Lead ECG Cable Set M1669A M1671A M1672A M1673A M1674A M1675A M1678A 3-Lead Trunk Cable 3-Lead ICU Grabber (AAMI) 3-Lead ICU Grabber (IEC) 3-Lead ICU Snaps (AAMI) 3-Lead ICU Snaps (IEC) 3-Lead OR Grabber (AAMI) 3-Lead OR Grabber (IEC) 5-Lead ECG Cable Set M1668A M1968A M1971A M1644A M1645A M1973A M1974A M1976A M1978A M1979A M1984A M1602A M1604A 5-Lead Trunk Cable 5-Lead ICU Grabber (AAMI) 5-Lead ICU Grabber (IEC) 5-Lead ICU Snaps (AAMI) 5-Lead ICU Snaps (IEC) 5-Lead OR Grabber (AAMI) 5-Lead OR Grabber (IEC) 5-Lead Chest ICU Grabber (AAMI) 5-Lead Chest ICU Grabber (IEC) 5-Lead Chest OR Grabber (AAMI) 5-Lead Chest OR Grabber (IEC) 5-Lead Chest ICU Snaps (AAMI) 5-Lead Chest ICU Snaps (IEC) Bluetooth transmission Internal Bluetooth Card ECG Electrodes M4612A M4613A Solid Gel ECG Electrodes, 5 electrodes/pack (60 packs/case) Solid Gel ECG Electrodes, 30 electrodes/pack (10 packs/case) 20

27 Supplies and Accessories SpO 2 Sensors and Cables M1191T Reusable Adult Finger Sensor (Nellcor 9-pin D-sub connector) M1192T Reusable Pediatric Sensor (Nellcor 9-pin D-sub connector) M1196A Reusable Clip Adult Sensor M1196T Reusable Clip Adult Sensor (Nellcor 9-pin D-sub connector) Note: The M1903B and M1904B SpO 2 sensors are no longer on the approved supplies list for the HeartStart MRx. Their adapter (M1943A) has also been removed from the approved supplies list. Invasive Pressure Transducers* TransPac IV TruWave PX212 DTX Plus DT-4812 Disposable transducer Disposable transducer Disposable transducer * - Contact the individual manufacturers for purchasing and service information. For a complete list of HeartStart MRx supplies and accessories see the HeartStart MRx Instructions for Use. WARNING Use only supplies and accessories approved for use with your HeartStart MRx. Use of non-approved supplies and accessories could affect performance and results. WARNING Use single-use supplies and accessories only once. To order supplies and accessories: In the USA, call (pads, electrodes, cables, paper, etc.). Outside the USA, contact your local Philips Medical Systems Sales Office, your authorized Philips Medical Systems Dealer or Distributor, or visit our website at: and follow the Supplies link. 21

28 Edition 1 Philips Medical Systems Printed in the U.S.A. July 2007 * * *1*