CARELINK ENCORE™ 29901 Programmer for Medtronic and Vitatron Devices Reference Manual
CARELINK ENCORE™ 29901 Reference Manual A guide for setting up and using the CareLink Encore 29901 Programmer.
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Medtronic CARELINK ENCORE™ 29901 Contents 1 Introduction to the programmer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 1.1 CE mark of conformity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 1.2 Explanation of packaging and product symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 1.3 About this guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Medtronic 3.8 3.9 3.10 3.11 3.12 3.13 CARELINK ENCORE™ 29901 Check the software version . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Select other software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Remove other software applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Improve the detection of pacing artifacts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Medtronic 7.5 7.6 7.7 7.8 8 8.1 8.2 8.3 8.4 8.5 CARELINK ENCORE™ 29901 Use Manual SessionSync for supported devices . . . . . . . . . . . . . . . . . . . . . . . . SessionSync error message descriptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . View SessionSync Status screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Update SessionSync status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Medtronic CARELINK ENCORE™ 29901 1 Introduction to the programmer 1.1 CE mark of conformity CE Mark Models Applies to all Medtronic hardware and software (including 29901 and desktop software SW028). Applies to all Vitatron software (including desktop software VSH02). Applies to Bluetooth only. 1.2 Explanation of packaging and product symbols Refer to the package label and product to see which symbols apply to this product.
Medtronic CARELINK ENCORE™ 29901 ACMA (Australian Communications and Media Authority) and the New Zealand Ministry of Economic Development Radio Spectrum Management standards for radio communications products symbol for Australia and New Zealand. MIC (Ministry of Internal Affairs and Communications) symbol for Japan ICASA (Independent Communications Authority of South Africa) mark for South Africa. Use only with specified power supply.
Medtronic CARELINK ENCORE™ 29901 USB port DC input ExpressCard Battery VGA monitor Manufacturer Date of manufacture Authorized representative in the European community Reorder number Serial number Lot number Humidity limitation Package contents Programmer, software installed 10 Reference Manual
Medtronic CARELINK ENCORE™ 29901 Power cord Product documentation Accessories Programmer Stylus / tether Programming head Power supply Power cord Battery China RoHS This product contains lead (Pb). Do not dispose of this product in the unsorted municipal waste stream. Dispose of this product according to local regulations. See http://recycling.Medtronic.com for instructions on proper disposal of this product.
Medtronic CARELINK ENCORE™ 29901 Do not wrap cord behind head Do not wrap cord around head 1.3 About this guide This guide describes the features and functions of the CareLink Encore 29901 Programmer (referred to as the “programmer”). Note: Screen images in this guide are for reference only. The content and presentation may vary depending on user selections, desktop, and device being interrogated. 1.
Medtronic CARELINK ENCORE™ 29901 1.5 Intended use The programmer is intended to be used to interrogate and program Medtronic and Vitatron implantable devices. 1.6 Contraindications There are no known contraindications to the use of the 29901 Programmer; the 29901 Programmer does not provide therapy. 1.7 Warnings These warnings apply in general to using the programmer for programming implantable device parameter settings.
Medtronic CARELINK ENCORE™ 29901 medical electrical systems (see IEC 60601-1-1 or clause 16 of the 3rd edition of IEC 60601-1, respectively). Anyone connecting additional equipment to medical electrical equipment configures a medical system and is therefore responsible that the system complies with the requirements for medical electrical systems. Local laws take priority over the above mentioned requirements. If in doubt, consult your local Medtronic representative or the technical service department.
Medtronic CARELINK ENCORE™ 29901 Internal electrodes – Do not connect the programmer to wires or electrodes internal to the body. The programmer is designed to be medically safe only when attached to surface electrodes. Internal RTC battery replacement – The real-time clock (RTC) battery, located inside the programmer on a circuit board, is not replaceable by the user. The battery needs replacement if the time-of-day clock cannot keep time. Return the programmer to Medtronic for replacement.
Medtronic CARELINK ENCORE™ 29901 Use of wireless devices – The programmer incorporates radio-frequency (RF) communications components which may affect other devices and equipment in the medical environment. The use of wireless devices in the medical environment must be evaluated and authorized by the responsible organization. RF interference may affect device performance. 1.8 Precautions Care in handling ECG cable wire – Do not pull on the insulated cable wire to disconnect the cable.
Medtronic CARELINK ENCORE™ 29901 Programmer and power cord positioning – Position the programmer and power cord so that the power cord can be easily accessed and disconnected. If it is necessary to remove the programmer from the AC mains, the power cord is the power disconnect at the mains outlet. Connection or disconnection of programming head – Do not connect or disconnect the programming head while the programmer power is on.
Medtronic ● ● ● ● CARELINK ENCORE™ 29901 Electrically-operated medical devices, such as the programmer require special care (in terms of electromagnetic compatibility) when being installed. Refer to the accompanying insert: Electromagnetic Compatibility Declaration. Do not open the device. The programmer is constructed to minimize risk from environmental factors. Opening the unit may make the unit susceptible to environmental factors and may expose the patient or user to hazardous voltage or current.
Medtronic CARELINK ENCORE™ 29901 1.10 Regulatory compliance 1.10.1 US Federal Communications Commission (FCC) See label on bottom of programmer for specific ID number for your programmer. 1.10.1.1 The following provision applies to the low frequency communications system in the device: This device complies with Part 15 of the FCC Rules.
Medtronic CARELINK ENCORE™ 29901 1.11.2 Telemetry functions: ● ● ● ● Automatic detection of the device model, and automatic application start-up, if the programming head is in proper position when the programmer is turned on. Automatic confirmation of a programmed change. Reporting of currently programmed parameter values in effect, battery status of the implanted device, saved implantable system information, and patient status information.
Medtronic CARELINK ENCORE™ 29901 1.12 Security features of the programmer Good security practices are needed to protect patient data and the integrity of any network-connected product. The programmer incorporates features that facilitate management of security. These features work in conjunction with the security practices of hospitals and clinics to provide safe and secure operation of the programmer and protect the attached network. 1.12.
Medtronic CARELINK ENCORE™ 29901 1.12.3 What to do if you suspect the programmer has been compromised If you believe that the programmer has been compromised by a security threat, turn off the programmer, disconnect it from the network, then restart the system. Discontinue use of the programmer if it does not behave as expected. Contact your Medtronic or Vitatron representative for further assistance. 1.13 Software requirements The programmer requires software from Medtronic and Vitatron to operate.
Medtronic CARELINK ENCORE™ 29901 1.15 Obtain technical manuals Medtronic technical manuals, including the manual you are reading, are available in a number of different formats from the Medtronic eManuals website listed on the back cover of this manual. The website offers real-time access to the latest version of manuals 24 hours per day, seven days per week. Manuals can be viewed online, downloaded for viewing or printing, or ordered from the website. All manuals are available online in English.
Medtronic CARELINK ENCORE™ 29901 2 Set up the programmer 2.1 System components Figure 1. Programmer components - front view 1 2 3 4 5 6 Programming head Button panel Stylus and Tether Product documentation Ethernet cable (not supplied) Display screen 7 8 9 10 11 Battery Power cord Power supply Electrode leads (not supplied) ECG cable with plug (not supplied) Warning: Use only the specified, Medtronic-supplied power cord, power supply, and components.
Medtronic CARELINK ENCORE™ 29901 Display screen – Display can be positioned horizontally, vertically, or at an angle. Programming options are selected on the screen with the stylus. Stylus – Used to select options on the display screen. Predetermined options are selected by applying the stylus to the screen. Ethernet cable – Used to connect the programmer to the clinic’s network. The Ethernet cable must be Category 5 or better. (Not supplied by Medtronic.
Medtronic CARELINK ENCORE™ 29901 Figure 3. Left view 1 USB ports 2 VGA output port 3 Integrated Ethernet 4 Power input USB port(s) – Allows installation of software, software updates, and future device application installations. The USB port can also be used to connect to a USB printer or a USB flash drive. VGA output port – Allows porting the screen image of the programmer to an external VGA monitor or for conversion of the output signal to NTSC/PAL format for presentation on a television monitor.
Medtronic CARELINK ENCORE™ 29901 Figure 4. Back view (doors open) 1 Programming head connector 2 ECG cable connector 2.2 Programmer button panel Figure 5.
Medtronic CARELINK ENCORE™ 29901 Table 1. Buttons and indicators on the programmer button panel Button or indicator Name Electronic Strip Chart (eStrip) button Function Used to insert a highlight into the recorded Electronic Strip Chart (eStrip) waveform data. Emergency VVI button Provides immediate access for emergency VVI pacing during a session. RFID button Not used. Bluetooth button Used to enable or disable Bluetooth power. For information about programmer Bluetooth capability, see Section 2.
Medtronic ● Turn on the programmer ● Position the programmer ● Connect the ECG cable ● Troubleshoot potential interference CARELINK ENCORE™ 29901 2.3.1 Attach and store the stylus Figure 6 shows how to attach and store the stylus. Figure 6. Attach and store the stylus 1 Attach one end of the tether to the stylus and the other end to the programmer. 2 Store the stylus in the handle of the programmer by inserting it into the hollow end of the handle, tip first.
Medtronic CARELINK ENCORE™ 29901 2.3.2 Connect the programming head 1. Open the door on the left rear of the programmer. 2. Line up the black arrows on the programming head cable and the programming head connector. 3. Plug the cable into the programming head connector with the yellow marker. 4. Close the door, making sure the cable passes through the notch on the bottom of the door. Warning: Do not connect or disconnect the programming head while the programmer power is on.
Medtronic CARELINK ENCORE™ 29901 2.3.3 Install the battery 1. Open the battery door on the lower right side of the programmer by pressing forward on the battery door recess and flipping the door to the left. 2. Slide the battery in until you hear it click into position. The battery is kept in position by a hook located on the bottom of the opening. 3. Close the battery door.
Medtronic CARELINK ENCORE™ 29901 2.3.4 Connect the power supply 1. Open the power input cover on the lower left side of the programmer. 2. Plug the power supply into the programmer. 3. Plug the power cord into the power supply. 4. Position the programmer and power cord so that the power cord can be easily accessed and disconnected. 5. Plug the power cord into the AC power outlet (AC mains).
Medtronic CARELINK ENCORE™ 29901 2.3.5 Turn on the programmer 1. Locate the Power button on the front right corner of the programmer button panel. 2. Press and release the Power button. 2.3.6 Position the programmer The programmer can be positioned horizontally or at an angle. 1. To position the programmer at an angle, pull out the stand on the rear of the programmer. 2. Place it at a comfortable viewing angle.
Medtronic CARELINK ENCORE™ 29901 Caution: Do not place fingers in the hinge area when opening or closing the stand. A painful pinch may result. 2.3.7 Connect the ECG cable 1. Open the right rear door. 2. Line up the ECG cable with the arrow next to the ECG connector. 3. Plug the cable into the connector. 4. Close the door, making sure that the cable passes through the notch on the lower left side. Notes: ● Improper insertion of the ECG cable plug may damage the connector pins.
Medtronic CARELINK ENCORE™ 29901 2.3.8 Troubleshoot potential interference To address possible harmful interference between the programmer and other devices, you are encouraged to take one or more of the following measures to address the situation: ● Reorient or relocate the devices. ● Increase the separation between the devices. ● Connect the equipment to an outlet on a different circuit. ● Consult Medtronic or Vitatron for help. 2.4 Charge the battery 2.4.
Medtronic CARELINK ENCORE™ 29901 Table 2. Indicator color and indication Indicator Battery Status indicator is solid amber Battery Status indicator is flashing amber Battery Charge indicator is solid green Battery Charge indicator is flashing green Indication The programmer is running on battery power, battery power is 20% or less than the full charge, and the programmer should plugged into AC power to be recharged.
Medtronic CARELINK ENCORE™ 29901 By holding the button for more than 5 seconds until the lights start to flash, the indicator lights display the indication of how the charge capacity has degraded with respect to the original design capacity after an amount of time or number of charge cycles. Figure 8. 80-100% of the original/new charge capacity Figure 9. 60-79% of the original/new charge capacity Figure 10.
Medtronic CARELINK ENCORE™ 29901 All printers listed by this software are certified to IEC 60950-1, UL 60950-1 or equivalent. Only printers listed by this software may be connected to the programmer. 2.5.1 Printer compatibility The programmer is compatible with many printers. A list of compatible printers can be accessed from the Print Queue screen. Note: When programming a Vitatron device, refer to the applicable Vitatron reference guide for information about printing. 2.5.
Medtronic CARELINK ENCORE™ 29901 2.5.4.1 Connect to a printer with a USB cable 1. To connect to a printer with a USB cable, locate a USB port. There are two USB ports located on the left front side of the programmer. 2. Open the input cover on the upper left side of the programmer. 3. Connect the printer cable to a USB port on the programmer. 4. Connect the other end of the cable to the printer. Connect the printer power cord to an outlet and turn on the printer. Make sure that the printer has paper. 5.
Medtronic CARELINK ENCORE™ 29901 2.5.4.2 Connect to a printer with Bluetooth (Bluetooth enabled programmers only) 1. To connect to a printer with Bluetooth, turn on the programmer and turn the Bluetooth radio on for the programmer by pressing the Bluetooth button on the programmer button panel. Note: Your programmer may or may not have Bluetooth capability. If the Bluetooth button does not illuminate when pressed, your programmer is not enabled for Bluetooth printing. 2.
Medtronic CARELINK ENCORE™ 29901 The programmer will automatically identify which method is needed to pair with a specific printer. a. To pair using a PIN, enter the PIN code found on the printer or in the printer manual. The PIN can be between 1 and 16 characters. When you tap the PIN text field the on-screen keyboard is displayed. Enter the PIN with the on-screen keyboard in the Pair Bluetooth Printer window. After the PIN has been entered, press [OK]. b.
Medtronic CARELINK ENCORE™ 29901 3 Configure the programmer 3.1 Display screen features The programmer display screen is a touch-sensitive interface that displays text and graphics. It is also a control panel that displays buttons and menu options that you can select. 3.1.1 Features and conventions of the display screen This section provides an overview of the features of the display screen. For more information, see the reference guide for the implanted device.
Medtronic CARELINK ENCORE™ 29901 Vitatron display screens may be different. For more information, see the reference guide for the implanted device. If you see a Medtronic/Vitatron switch button, press it to display the Vitatron Select Model screen. 3.1.1.1 Task bar The task bar can contain these icons/indicators: Table 3. Task bar icons/indicators Icon Name Telemetry strength SessionSync Function Turns green to indicate successful communication between the programming head and the device.
Medtronic CARELINK ENCORE™ 29901 Table 3. Task bar icons/indicators (continued) Icon Name Electronic Strip Chart (eStrip) selector Function Used to go to the Electronic Strip Chart (eStrip) recorder screen. Device Application selector Used to go to the Select Model screen on the programmer desktop. During a patient session, the indicator box turns blue to indicate that the programmer is on a device application screen. 3.1.1.2 Status bar Before selecting a model, the status bar has no information.
Medtronic CARELINK ENCORE™ 29901 3.1.1.6 Buttons Buttons allow you to operate the programmer. You can “press” a button by touching it with the tip of the stylus or your finger. Buttons may directly execute a command, such as [Freeze], or they may open a window that prompts another action. Buttons that open a window usually have a label ending with an ellipsis, such as [Strips…] or [Adjust…]. A procedure may instruct you to “press and hold” a button.
Medtronic CARELINK ENCORE™ 29901 Table 4. Between Patient Sessions tool palette (continued) Tool Selecting the tool (button or icon)… Displays the screen for selecting a model and starting a patient session. Displays a queue of print requests from previous sessions as well as frozen waveform reports requested between sessions. Refer to the reference guide for the implanted device to determine if these features are available. Displays the programmer setup options.
Medtronic CARELINK ENCORE™ 29901 3.4 Use the on-screen keyboard The on-screen keyboard is used for entering text into an editable field. When you tap in an editable field, the on-screen keyboard displays. When you tap outside the editable field, the on-screen keyboard stops displaying. For fields that have frequently re-used names, terms or medical terminology, a selectable library displays when the field is selected. The library provides you with the ability to add or reuse words when entering text. 3.
Medtronic CARELINK ENCORE™ 29901 Figure 12. Programmer Profile screen 3.6 Adjust programmer time and date If the time or date displayed and printed by the programmer is incorrect, use the following procedure to enter the correct settings. For Vitatron devices, see the applicable reference guide. 3.6.1 Set the time and date 1. Press the Programmer icon then Time and Date. 2.
Medtronic CARELINK ENCORE™ 29901 Figure 13. Programmer Time and Date screen Note: Time must be entered based on a 24-hour clock, with 00:00 being midnight, and 12:00 being noon. 3.7 Select audible tones Certain events in the operation of the programmer result in an audible signal. The following tones alert you to the success or failure of an action. ● ● A two-tone beep (low-to-high) indicates confirmation of an Interrogate or a Program command.
Medtronic CARELINK ENCORE™ 29901 Figure 14. Audio Preferences screen 3.8 Check the software version This section describes how to determine the version of software that is loaded on the programmer. If you need to know what version of software is currently loaded on the programmer for any of the device models, use the following procedure. For Vitatron devices, see the applicable reference guide. 3.8.1 To check the software version number 1. Select Programmer, and then select Software. 2.
Medtronic CARELINK ENCORE™ 29901 Figure 15. Software on This Programmer screen Note: If the model that you require is not displayed, the software to support that model is not currently loaded on the programmer. Contact your Medtronic or Vitatron representative. 3.9 Select other software In addition to the standard application software, there are some programmers that have other applications installed. These applications may include supplemental software or software used in clinical studies for research.
Medtronic CARELINK ENCORE™ 29901 1. Press the Programmer icon, and then select Software. 2. Press [Uninstall Software…]. 3. When the programmer displays the list of removable software, select the application to be removed, and then press [Uninstall]. 4. Select the check box next to the acknowledgment statement, and then press [Continue]. 5. The software is removed, and the programmer reboots. 6. Verify that the software has been removed. 3.
Medtronic CARELINK ENCORE™ 29901 3.12.1 Access demonstrations 1. Press the Programmer icon, and then select Demonstrations. 2. From the Demonstration Model Selection screen, select the desired View option to list the available demonstration programs. 3. Select the desired demonstration program and press [Start] followed by [Continue]. 3.13 Configure network using the Network Configuration window 3.13.1 About the Network Configuration window Figure 16.
Medtronic CARELINK ENCORE™ 29901 3.13.2 Configure network connection 1. Press the Network Configuration icon on the task bar. The programmer displays the Network Configuration window. 2. Select the radio button for SDN or SessionSync. Note: If you selected SessionSync, you also need to enter the SessionSync Gateway Address. The field is visible only after selecting SessionSync. 3. Enter the Clinic Name. 4. Enter the Network Name (SSID).
Medtronic CARELINK ENCORE™ 29901 Use the Test Network Connection feature if your programmer is having difficulty connecting to your clinic’s network. Contact Medtronic Technical Support if you need assistance in interpreting results. 3.13.5 Save network connection test results to media 1. Connect a USB flash drive to the programmer. 2. Press [Save To Media]. Note: This button is available only if the Test Network Connection tests have been run. The programmer displays the Save to Media dialog. 3.
Medtronic CARELINK ENCORE™ 29901 4 Update programmer software using the Software Distribution Network 4.1 The Software Distribution Network Programmer software can be updated by Medtronic customers or Medtronic personnel by accessing the Medtronic Software Distribution Network (SDN) and downloading the software. The SDN uses a world-wide network to connect to servers in the United States. These servers are able to download software to many programmers simultaneously through secure connections.
Medtronic CARELINK ENCORE™ 29901 4.2.1 Connect the Ethernet cable 1. Open the input cover on the lower left side of the programmer. 2. Connect the Ethernet cable to the Integrated Ethernet connection. 3. Connect the opposite end of the Ethernet cable to a network jack.
Medtronic CARELINK ENCORE™ 29901 4.2.2 How to connect to the SDN using a wired network connection 1. Press the Programmer icon, and then select Software. The programmer displays the Software on This Programmer screen and lists the software already installed on the programmer. For each model, the screen displays the software version. Note: The SDN cannot be accessed from Vitatron screens. Change to the Medtronic Select Model screen. 2. Press [Install from Medtronic…]. 3.
Medtronic CARELINK ENCORE™ 29901 4. The programmer displays the Scheduled Software Update screen. Choose to either start the download at a particular time by selecting a time from the Scheduled Update Time pull-down menu, or begin the download as soon as possible by pressing [Start]. 5. The Scheduled Software Update window displays a countdown window showing how much time remains until the download begins.
Medtronic CARELINK ENCORE™ 29901 6. The programmer displays a list of software that will download and install. Note: Individual software cannot be selected or rejected. You may press [Stop] at anytime and resume the download at a future time. 7. When the download is complete, the programmer disconnects from the SDN, automatically reboots, and displays a screen listing the software that was downloaded. 8. To obtain technical manuals for the new software, see Section 1.15. 9. Press the Select Model icon.
Medtronic CARELINK ENCORE™ 29901 4.3 Connect to the SDN using a wireless network connection Note: Before you begin, make sure that the wireless connection is correctly configured. For more information, see Section 3.13. 4.3.1 How to connect to the SDN using a wireless network connection 1. Press the Programmer icon, and then select Software. The programmer displays the Software on This Programmer screen and lists the software already installed on the programmer.
Medtronic CARELINK ENCORE™ 29901 4. The programmer displays the Scheduled Software Update screen. Press [Configure]. 5. On the Scheduled Software Update screen, either choose to start the download at a particular time by selecting a time from the pull-down menu, or begin the download as soon as possible by pressing [Start]. The programmer shuts down and displays a window telling you to please wait. 6.
Medtronic CARELINK ENCORE™ 29901 7. The programmer displays a list of software that will download and install. Note: Individual software cannot be selected or rejected. You may press [Stop] at anytime and resume the download at a future time. 8. When the download is complete, the programmer disconnects from the SDN, automatically reboots, and displays a screen listing the software that was downloaded. 9. To obtain technical manuals for the new software, see Section 1.15. 10. Press the Select Model icon.
Medtronic CARELINK ENCORE™ 29901 5 Conduct a patient session 5.1 Prepare for a patient session Familiarize yourself with the information in this section before beginning a patient session. 5.1.1 Connect the programmer to skin electrodes At the start of each patient session, ECG cable leads must be connected to the patient to detect cardiac and pulse artifact signals.
Medtronic CARELINK ENCORE™ 29901 5.1.3 Connect the ECG cable 1. As shown, attach a color-coded lead wire to each of the four electrodes. Match a color to each electrode as in Table 5. Note: The chest lead is not used. The middle cable port of the ECG cable is sealed off with the chest ECG plug. 2. Connect each lead wire to the ECG cable as in Table 6. Match each lead connector to the proper cable port. Table 5.
Medtronic CARELINK ENCORE™ 29901 Note: Occasionally, mutual interference occurs between the programmer skin electrode signals and signals from an external ECG recorder or monitor attached directly to the patient. This interference may cause erratic operation of the programmer functions that depend on surface signal detection. If interference occurs, temporarily disconnect the leads from the attached ECG recorder or monitor. This interference does not affect the programming functions of the programmer. 5.
Medtronic CARELINK ENCORE™ 29901 5.1.5 Select an option on the screen Figure 18. Position the stylus 1. Move the tip of the stylus to a position directly over the desired option. If the desired option is a displayed key or button, position the stylus tip within the rectangular outline. If the desired option is a name or number, such as a parameter or parameter value, position the stylus directly over the letters or numbers forming the option. 2. Touch the stylus to the screen to select an option. 5.1.
Medtronic CARELINK ENCORE™ 29901 During a patient session, properly position the programming head over the implanted device before any of the following actions: ● ● ● Selection of any command that initiates a programming transmission. The programming head must be held in position until completion of the transmission, which usually is indicated by a confirmation message. Selection of any command that initiates data transmission from the implantable device.
Medtronic CARELINK ENCORE™ 29901 Figure 19. Position the programming head 1 Light array 2 Green 3 Amber/green 4 Antenna Correct placement of the programming head is indicated in two places: the position head array in the top left corner of the screen and the array of seven lights on the programming head (see Figure 19). Programming and Interrogation are not recommended when fewer than three green lights are lit. Note: The number of lights used on the light array may vary for some devices.
Medtronic CARELINK ENCORE™ 29901 Notes: ● ● ● If the programmer is operated in an environment in which the ambient temperature is 35 °C, the programming head may reach a temperature of 42 °C. The programming head array shows the signal strength of the communication link. Medtronic recommends moving the programming head to maximize the number of green lights. All lights may not illuminate for all models. For more information, see the reference guide for the implanted device.
Medtronic CARELINK ENCORE™ 29901 3. Is the battery installed and charged? 4. If you are charging the battery or are using AC power instead of the battery, does the power supply cord connect the programmer to a hospital-grade outlet? 5. Has the appropriate software been installed? Refer to Section 3.8 for a description of how to verify the software version. 6. Are the programmer ECG cable leads connected to electrodes on the patient as described in Section 5.1.
Medtronic CARELINK ENCORE™ 29901 When the Find Patient screen is displayed, you may begin a patient session. Place the programming head over the patient’s device and hold it steady. For most devices, the programmer identifies the device model and automatically starts up the proper software application. If a device cannot be automatically identified, the programmer displays a message at the top of the Find Patient screen.
Medtronic CARELINK ENCORE™ 29901 5.2.2.2 Select Model screen A patient session may also begin from the Select Model screen. The Select Model screen appears after one of the following actions: ● Shortly after the programmer has been turned on ● After you end a patient session If the Select Model screen is not displayed, use the stylus to press the Select Model icon. If the Select Model icon is not displayed, a patient session is in progress. You must end that session before starting a new session.
Medtronic CARELINK ENCORE™ 29901 When a device is manually selected from the list of devices, the programmer starts up the application that corresponds to your selection, not the device that is under the programming head. The Find Patient screen is displayed briefly as the programmer starts up the proper software application. If the software application has not been installed, the programmer displays a message indicating that the software must be installed before proceeding.
Medtronic CARELINK ENCORE™ 29901 5.3.1 eStrip recorder screen features Figure 20. eStrip recorder screen 1 2 3 4 Real-time waveform viewer–shows real-time waveforms. Holter view selector–shows overview of waveforms. List view selector–shows available strips. Expanded view–shows expanded view of a segment of a waveform. 5.3.2 eStrip recorder screen icons/selectors The eStrip recorder screen contains these icons/selectors: Table 7.
Medtronic CARELINK ENCORE™ 29901 Table 7. Icons/selectors on the eStrip recorder screen (continued) Icon Name Undo Function Erase the most recent caliper or markup. Redo Replaces the most recently erased caliper or markup. Print Opens the print screen. Add highlight Add highlight to previously unhighlighted waveform. Remove highlight Removes existing highlight from a waveform. Strip preferences Opens preferences screen. Chart speed adjust Previous highlight Presents chart speed choices.
Medtronic CARELINK ENCORE™ 29901 5.3.4 Change the length of a strip 1. Select a strip. 2. Press and hold the border of the strip. 3. Drag the border of the strip to make it longer or shorter. 5.3.5 Measure intervals using calipers 1. Select a strip. 2. Press the Caliper icon. 3. Press the arrow icon on the bottom right corner of the strip to walk the calipers. 4. To save caliper measurement to strip, press the tack icon. 5.3.6 Change the name of a strip 1.
Medtronic CARELINK ENCORE™ 29901 5.4 Emergency VVI button The red emergency VVI button on the programmer button panel provides immediate access for emergency VVI pacing during a patient session. Pressing the red emergency VVI button displays the emergency screen options and delivers VVI pacing. Figure 21. Programmer button panel 1 Red emergency VVI button Specific parameter values for emergency VVI pacing are determined by each device application.
Medtronic CARELINK ENCORE™ 29901 5.5 End a patient session When you want to end a patient session, you may save data to a supported storage device or end the session without saving. Refer to the reference guide for the implanted device for specific information on saving device data. 5.6 Store components Figure 22 shows the proper way to store components. Figure 22. Store components 1 Store the stylus in the handle of the programmer. 2 Store the programming head in the left rear door.
Medtronic CARELINK ENCORE™ 29901 6 Manage session data and reports 6.1 Session data Patient session data may be saved to a USB flash drive. 6.2 Reports Depending on the implanted device model, various types of reports can be created. Refer to the reference guide for the implanted device for specific information on report types and contents. During an active session, reports may be printed, or saved as PDF files on a USB flash drive.
Medtronic CARELINK ENCORE™ 29901 6.4 Save to USB Many device applications support the use of USB flash drives for saving and loading session data. Note: Device applications and reference manuals may still use the terms “disk” or “diskette” in the context of saving and retrieving device data. When a USB flash drive is connected to the programmer and available for use as described below, the terms disk or diskette should be interpreted as applying to the USB flash drive, rather than the diskette. 6.4.
Medtronic CARELINK ENCORE™ 29901 Notes: ● ● ● While a Save to Media action is in progress, the progress indicator and the message “Saving…” display. The progress indicator displays the completion percentage. Before removing the USB flash drive, wait a few seconds after the progress indicator shows 100%. After a report is saved as a PDF file, the message “PDF report(s) saved to media” is displayed for about 5 seconds. Wait a few seconds after the message goes away before removing the USB flash drive.
Medtronic CARELINK ENCORE™ 29901 6.6 View reports on the programmer using PDF Viewer The PDF Viewer allows you to view and print PDF reports previously saved on a USB flash drive. 1. Connect a USB flash drive with saved PDF reports. 2. Select the PDF Viewer in the taskbar. The list of the available PDF files on the USB flash drive is displayed in the left panel. 3. Click the file name to open a preview of the PDF.
Medtronic CARELINK ENCORE™ 29901 PDF reports print properly at a resolution of 300 dpi or greater. 6.8 Manage patient data privacy You can immediately remove from the programmer all Protected Health Information (PHI).
Medtronic CARELINK ENCORE™ 29901 2. Press [Delete Protected Health Information]. The programmer displays the dialog box as shown in Figure 25. Figure 25. Delete Protected Health Information confirmation dialog box 3. Press [Delete] to continue. One of the following events may occur: The programmer displays an “In progress…” dialog box as shown in Figure 26. Deletion may last several minutes, depending on the amount of data to delete. Figure 26.
Medtronic CARELINK ENCORE™ 29901 If there are reports currently printing, the programmer displays a message directing you to wait until printing is complete, as shown in Figure 28. Press [Close]. Figure 28. Printing in progress dialog box 4. If pressing [Delete] in Step 3 resulted in protected health information deletion, the programmer displays a message stating that deletion was successful, as shown in Figure 29. Press [Close]. Figure 29.
Medtronic CARELINK ENCORE™ 29901 6.9 Set the interval for report deletion For patient data security, the programmer permanently deletes reports automatically from the Medtronic desktop print queue at the time when the programmer is powered up. You can control how long reports are retained in the print queue before automatic deletion. 6.9.1 Select a report deletion interval 1. Press the Programmer icon, and then select Preferences. 2. From the Preferences screen, select Delete Reports.
Medtronic CARELINK ENCORE™ 29901 6.9.2 Delete a report immediately To delete a report immediately, directly access it from the print queue and press [Delete].
Medtronic CARELINK ENCORE™ 29901 7 SessionSync (Optional) 7.1 About SessionSync SessionSync is an optionally installed feature that provides network connectivity between the programmer and the Medtronic Paceart data management system. Using your clinic’s network, the programmer can send downloaded device data through SessionSync to the data management system.
Medtronic CARELINK ENCORE™ 29901 7.3 SessionSync Status icon The SessionSync status icon provides information on the network connection between the programmer and the data management system. Figure 33. The task bar with the SessionSync Status icon 1 The SessionSync Status icon If SessionSync is not installed on the programmer, the icon is not visible in the task bar. Figure 34.
Medtronic CARELINK ENCORE™ 29901 Table 8.
Medtronic CARELINK ENCORE™ 29901 3. The SessionSync - Saving Session Data On Programmer window is opened. For some devices, an interrogation is automatically started. The SessionSync - Saving Session Data On Programmer window shows the progress of the save. The programmer side of the SessionSync Status icon turns blue after the data has been saved on the programmer hard disk. If the subsequent transfer is successful, the data management system side of the SessionSync Status icon turns blue. 7.
Medtronic CARELINK ENCORE™ 29901 Table 9. SessionSync error messages (continued) Error Message Interrogate - Unsuccessful Unable to Save Session Data What it means The programmer cannot interrogate the device. You must reposition the programming head. Do one of the following: Press [Retry] or [Continue] after repositioning the programming head. Press [Cancel] to close the window. The session data cannot be saved on the programmer hard disk.
Medtronic CARELINK ENCORE™ 29901 1. Press the Programmer icon, and then select SessionSync Status. 2. Press [Update Status]. Note: SessionSync status does not dynamically update when the window is open. To update, press [Update Status].
Medtronic CARELINK ENCORE™ 29901 8 Service the programmer 8.1 Clean the system components The exterior surfaces of the programmer and its accessories may be cleaned with a sponge or soft cloth moistened with water, mild detergent, hydrogen peroxide, or alcohol. Thoroughly clean the surfaces of the programmer wires; the bottom surface of the programming head; and the wire connecting the programming head to the programmer.
Medtronic CARELINK ENCORE™ 29901 8.2.1 Ethylene oxide Note: The programming head or ECG cable and lead wires must be completely dry before being ethylene-oxide sterilized. 1. Wrap the programming head or ECG cable and lead wires in packaging permeable to ethylene oxide. 2. Medtronic recommends normal gas concentration of 725 mg/L ethylene oxide followed by a minimum of 12 hours of aeration. The worst case cycle will consist of no more than 3 hours exposure to EO. 3. Do not exceed 55 °C, 50% RH. 4.
Medtronic CARELINK ENCORE™ 29901 8.3 Programmer specifications Table 10. Programmer specifications Standards (The programmer complies with the following:) Radio frequency wireless specifications and applicable standards EMC EN / IEC 60601-1-2 EN 301 489 EN 302 195 EN 55022 Class B/CISPR 22 EN 55024 Class B/CISPR 24 Radio FCC CFR 47 P.
Medtronic CARELINK ENCORE™ 29901 Table 10. Programmer specifications (continued) IEC 60529 Degrees of Protection Provided by Enclosures (IP Code) - AMD 7643: July 1993; AMD 10931: August 2000 Ingress IP21 (with the programmer turned off, and with both of the back doors, the battery door, all connector ports, the ExpressCard slot, and the input covers closed) Physical dimension and weight Height 35.5 cm Width 35.5 cm Depth 10.2 cm Weight 4.
Medtronic CARELINK ENCORE™ 29901 8.3.1 Functional test, maintenance, and safety checks 8.3.1.1 Functional test at installation Before putting the programmer into service for the first time, the device and its accessories should be visually inspected and tested for operability by a designated Medtronic person.
Medtronic CARELINK ENCORE™ 29901 8.3.2 Disposal of the programmer Return the programmer to Medtronic or Vitatron for proper disposal. 8.4 Special notice The CareLink Encore 29901 Programmer (the “programmer”) is designed to program the adjustable parameters of the Medtronic or Vitatron programmable implantable devices included in the applications of the software used with the programmer. Refer to the appropriate reference guides for a list of the implantable device models applicable to the software.
Medtronic CARELINK ENCORE™ 29901 A End-user license agreement A.1 End-user license agreement (EULA) terms You have acquired a device (“DEVICE”) that includes software licensed by Medtronic from an affiliate of Microsoft Corporation (“MS”). Those installed software products of MS origin, as well as associated media, printed materials, and “online” or electronic documentation (“SOFTWARE”) are protected by international intellectual property laws and treaties.
Medtronic CARELINK ENCORE™ 29901 NOT FAULT TOLERANT – THE SOFTWARE IS NOT FAULT TOLERANT. MEDTRONIC HAS INDEPENDENTLY DETERMINED HOW TO USE THE SOFTWARE IN THE DEVICE, AND MS HAS RELIED UPON MEDTRONIC TO CONDUCT SUFFICIENT TESTING TO DETERMINE THAT THE SOFTWARE IS SUITABLE FOR SUCH USE. NO WARRANTIES FOR THE SOFTWARE – THE SOFTWARE is provided “AS IS” and with all faults. THE ENTIRE RISK AS TO SATISFACTORY QUALITY, PERFORMANCE, ACCURACY, AND EFFORT (INCLUDING LACK OF NEGLIGENCE) IS WITH YOU.
Medtronic CARELINK ENCORE™ 29901 technologies to you. MS, Microsoft Corporation and their affiliates may disclose this information to others, but not in a form that personally identifies you. Internet Gaming/Update Features – If the SOFTWARE provides, and you choose to utilize, the Internet gaming or update features within the SOFTWARE, it is necessary to use certain computer system, hardware, and software information to implement the features.
Medtronic CARELINK ENCORE™ 29901 will be licensed by such entity under the same terms and conditions of this EULA, except that (i) MS, Microsoft Corporation or their subsidiaries providing the Supplemental Components will be the licensor with respect to such Supplemental Components in lieu of Medtronic for the purposes of the EULA, and (ii) TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, THE SUPPLEMENTAL COMPONENTS AND ANY (IF ANY) SUPPORT SERVICES RELATED TO THE SUPPLEMENTAL COMPONENTS ARE PROVIDED AS
Medtronic CARELINK ENCORE™ 29901 Regulations, as well as end-user, end-use and destination restrictions issued by U.S. and other governments. For additional information see http://www.microsoft.com/exporting/.
Medtronic CARELINK ENCORE™ 29901 Index A AC power input . . . . . . . . Adjust button . . . . . . . . . . [Adjust…] button . . . . . . . Adobe settings . . . . . . . . AHA coding electrodes . . . . . . . . annotations Marker Channel . . . . . parameter programming artifact detection . . . . . . . Auto Identify . . . . . . . . . . see also Find Patient B . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 45 45 83 . .
Medtronic CARELINK ENCORE™ 29901 I icons AC power indicator . . . . . . . . . . . . . . . . battery indicator . . . . . . . . . . . . . . . . . . battery power indicator . . . . . . . . . . . . . . Bluetooth configuration . . . . . . . . . . . . . device application indicator/selector . . . . . . Electronic Strip Chart (eStrip) indicator/selector inactive . . . . . . . . . . . . . . . . . . . . . . . network configuration . . . . . . . . . . . . . . . PDF Viewer . . . . . . . . . . . . . . . . . . . .
Medtronic reports deleting . . . . . . . saving to PDF . . . saving to USB . . . viewing . . . . . . . RFID button . . . . . . . RTTE Directive device conformance CARELINK ENCORE™ 29901 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87 80 81 82 28 . . . . . . . . . . . . . . . . . . 18 S screen Find Patient . . . . . . . . Select Model . . .
Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN 55432 USA www.medtronic.com +1 763 514 4000 Authorized Representative in the European Community Medtronic B.V.
