Renamic Quick Reference Guide June 2012

Active function

Patient name

Device name and serial number

Heart rate

Telemetry status in 6 stages (0 bars = 0% up to 5 bars = 100%) ECG monitor (values derived from real-time IEGM)

Button for setting the gain of the respective signal

Freeze function (ECG snapshot of the last 60 sec.)

Button for enlarging/reducing the ECG window

Settings for the ECG display Display area for status messages

Navigator with navigation buttons

Application window

Button for exiting the follow-up session. The start screen is displayed and all interrogated data and test results are stored.

Help function (accessible from any application window) Function buttons (depending on the current application window)

ECG window

Forward/back navigation

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16

Touch screen Device body USB ports ECG port Slot for expansion module Screen release button (right) Fixation for carrying strap (right) Pen holder PGH compartment lid release button Printer buttons Stylus in pen holder Safe program button Emergency shock button Carrying handle Fixation for carrying strap (left) Screen release button (left)

18 19 20 21 22 23 24 25 26 27 28 29 30 31

Paper tray for internal printer On/off button Power cord port and device fuse PGH port USB slot with Bluetooth USB adapter PGH cable and ECG cable Cable feedthrough for PGH cable On/off LED Programming head (PGH) PGH compartment lid Anti-slip stand Gripping tab Power cord in power cord storage compartment Power cord compartment lid

Navigation All parameters displayed in bold print can be selected. Other application windows are opened on selection.

Summary of the most important follow-up data.

Change the programmable parameters of the implanted device. Perform tests (e.g. threshold test). Display the signals recorded by the implanted device.

Open the patient data in the

[Parameters] application window. Open the list of recently recorded signals in the [Recordings] application window.

Open the corresponding test in the

[Tests] application window.

Display all interrogated implanted device statistics. Summary of the status of the implanted device. Print manager (list of all stored printing data). Adapt the basic settings for individual configuration.

Switching the device on and off The on/off button (19) is located on the back left side of the device. To switch on the device: • Press the on/off button (19) once to the pressure point. The on/off LED (25) on the front left side of the device lights up. To switch off the device: • Press the on/off button (19) once to the pressure point or • Shut down the device via the user interface. On/off button on the device

Button for switching off the device in the user interface.

Note: If the power supply to Renamic is interrupted, the device will require approximately 60 seconds to restart once the power supply is reconnected. If the power supply to Renamic is not interrupted and the device is switched off using the button on the screen or the on/off button on the device (19), then the device will require approximately 30 seconds to restart.

Freeze/Print Freeze function (ECG/IEGM recording) Renamic constantly stores the last 60 seconds of the real-time signals (IEGM, ECG and markers) displayed in the ECG window. The Freeze function can be used to pause the signal display in order to analyze events that have occurred within the last 60 seconds. Key below the ECG area to open the [Freeze] button.

Display of the IEGM amplitude (A, RV, LV) at the position of the left caliper (1) and the right caliper (2) Keys for precise placement of the caliper lines. The calipers can also be positioned on the ECG display itself (select, hold and drag).

(1)

(2)

Circle function to check constant distances between several events Button for printing the displayed recording section. The recording is simultaneously stored as a file in the follow-up data of the print and data manager tabs with the designation "Freeze". Button for saving as a file in the follow-up data of the print and data manager tabs with the designation "Freeze". Selection to print or store the entire length of 60 seconds, only the window contents, or the section between the caliper lines.

Printing during follow-up The [Print] button is available in every application window for immediate printing. All data interrogated and produced during follow-up are automatically stored and can be displayed in the Print manager tab at any time using the [More] button.

List of all stored follow-ups for the implanted device being interrogated.

The activated follow-up is highlighted in blue. The current follow-up session is selected by default.

List of available data for activated follow-up.

Keys for selecting the print profiles. The check boxes for available data are adapted to the respective profile.

Check box for selecting or deselecting the follow-up data to be printed.

Export Printing and exporting stored data Select the [Data manager] button on the start screen. All stored follow-up data can be viewed, printed, exported and sorted according to the displayed columns. Lines containing the same information in the sorted column are summarized. For example, if the follow-up data is sorted according to the "Patient" column, then all follow-up data for a single patient will be summarized. However, if the "Date" column is selected for sorting, then all follow-up data will be summarized for the same date but with various different patients.

Select a column header to sort and summarize the follow-up data. Edit the patient name selected with a check box. Use the arrows to expand or collapse the summarized follow-up data. Export the selected follow-up data in Adobe PDF format.

Data export settings. Export follow-up data that has been selected using the check boxes. Import follow-up data in BIOTRONIK backup format.

Data export settings Select the [Data manager] button on the start screen and then [Options] to configure the data export settings. Activate or deactivate the check boxes to set the format in which the follow-up data will be exported via the available interfaces (USB stick, Bluetooth adapter, serial RS 232 interface). Export to USB stick Select this function to transmit the export file in BIOTRONIK XML format and as a PDF document with each transmission.

Export to a device connected via a Bluetooth adapter (See Preferences for Bluetooth PIN)

Backup: Encrypted file format only for importing backup data on a BIOTRONIK Renamic or ICS 3000 programmer.

BIOTRONIK-XML: Open, freely available proprietary export format based on the XML standard. An XML file is created for each follow-up. Paceart-XML: Paceart compatible export format. An XML file is created for each follow-up.

When exporting to a USB stick, you can enter a destination directory for the data. The top level of the destination directory must be the "BIOTRONIK" directory. "USB stickBIOTRONIK..."

Preferences Adapting the settings Select the [Preferences] button in the navigator and then select the desired tab and enter your preferences.

[Follow-up] tab: Configures which measurements and tests are performed automatically during follow-up and how the results are output. [Tests] tab: Sets parameters affecting the test sequence during follow-up. [Print] tab: Configures a PCL compatible external printer that is connected via a USB or Bluetooth adapter, or sets up different printing profiles for printing the follow-up data. [System] tab: Sets the time, daylight saving time (DST) or winter time, date, language of the user interface and the help function. [Connectivity] tab: Sets up communication connections to other devices.

Settings for initial data export using the Bluetooth adapter The Bluetooth connection has to be established before Renamic can export data via the Bluetooth adapter. The Bluetooth search dialog box appears the first time an export is performed via the Bluetooth adapter. Once the search is finished, Renamic displays all devices available for connection. The first time an export is performed, the Renamic Bluetooth PIN must be entered into the PC that is to be connected via Bluetooth. The Bluetooth PIN for connecting the Renamic is: 1358. The Bluetooth connection only has to be configured once.

RF Telemetry Place Renamic in the ideal position for SafeSync RF telemetry Various factors can impair the quality of the SafeSync RF telemetry connection. The current connection quality (1) is displayed in the programmer’s status bar. This display can be used to determine the optimum position. In doing so, take the delay in the field strength display (1) into consideration.

1

(2)

(2) Preferred directions (2) for SafeSync RF telemetry

Proceed as follows if the connection quality is impaired: • Change the position of the programmer or its orientation to the implanted device by slightly rotating or moving it. When you do this, consider the delay in the field strength display (1) and observe the preferred direction for SafeSync RF telemetry (2). • Ensure that no objects or persons are located in the path between Renamic and the implanted device. • Position Renamic as far away as possible from other electrical devices. • Do not place the device to be implanted directly on metal surfaces, as the effectiveness of the antenna is significantly reduced in the vicinity of electrically conductive surfaces.

Placing paper in the printer tray

Push back the separator flap

Place the separator flap under top sheet

• Open the printer tray by applying slight pressure from above. • Do not pull the tray all the way out. • Removing the paper tray: Printers without release key: • Pull the tray all the way out. Printers with a release key: • Press down the key on the right side and pull the tray all the way out. • Push back the separator flap. • Pull back the top sheet of the ream of paper. • Insert the ream of paper into the tray from the top so that the wide marking on the ream of paper is on the left side. • Place the separator flap under the top sheet of paper. • Guide the top sheet over the separator flap and the rubber roller. • Push the tray into the device until it stops. If too much paper is in the tray and it is difficult to push into the device, remove some paper and repeat the steps. • The closure will lock automatically.

Note: This quick reference guide does not serve as a replacement for the proper technical manual of the device. Before using Renamic, please read the technical manual of the device including the safety warnings.

© BIOTRONIK SE & Co. KG All rights reserved. Specifications are subject to change without notice. 0123 0681 2010

12-X-30 Revision: D (2012-06-29)

BIOTRONIK SE & Co. KG Woermannkehre 1 12359 Berlin · Germany Tel. +49 (0) 68905-0 Fax +49 (0) 6852804 [email protected] www.biotronik.com