Medtronic 2090 Programming Guide

Programming guide

Software version 9.1 Model VSA02 (for 9790c) Model VSC02 (for Vitatron CareLink Programmer)

Caution: Federal Law (U.S.A.) restricts this device to sale or on the order of a physician (or properly licensed practitioner).

The following are trademarks of Vitatron B.V.:

Holding

Beat-to-Beat®Mode Switching, Sensor Blending®, Sensor Cross-Checking®, Clarity®,

Diamond

, Selection®, Ruby®,Topaz®, Jade®LegacyTMand Vita®.

1. Introduction 3

2. The screen layout 5

2.1 The Vitatron desktop 5

2.2 General screen layout 7

2.3 Menu options 9

2.4 Vitatron desktop tutorial 10

2.5 Scrolling 19

3. Follow-up 21

3.1 Start-up and Auto-Identify 21

3.1.1 Start-up 22

3.1.2 Selecting Auto-Identify 23

3.2 How to use the built-in ECG recorder 26

3.2.1. Using the ECG in the Vitatron desktop 26

3.2.2. Using the ECG during follow-up 27

3.3 How to program a parameter 34

3.3.1 Parameter programming 34

3.3.2 Parameter pertinency 36

3.3.3 Batch programming 37

3.3.4 Nominal programming 38

3.3.5 Additional programming for the Selection AFm 902 41

3.4 How to measure pacing thresholds 42

3.5 How to perform a sensing test 45

3.6 How to retrieve data 48

3.6.1 Status and Diagnostic Observations 49

3.6.2 Histograms 50

3.6.3 Holters 53

3.6.4 Mode Switching Trend 54

3.6.5 Selected Event Recording 55

3.7 How to set Diagnostic Features 57

3.7.1 Histograms or Holters 57

3.7.2 Mode Switching Trend 58

3.7.3 Selected Events 59

3.7.4 Additional Diagnostics for the Selection AFm 902 59

1Programming Guide

Table of contents

3.8 Results from Counters 66

3.9 Battery & lead data 67

3.10 How to print pacemaker data 68

3.11 How to save pacemaker data to diskette 70

3.12 How to enter patient data 71

3.13 How to temporarily program a parameter 76

3.14 How to set ECG markers 79

3.15 How to end a programming session 84

3.16 How to switch between Vitatron and

3.17 How to cancel/activate the programming

4. Programming reference 89

4.1 Programming the Clarity DDDR, Clarity SSIR,

4.2 Programming the Vita 2 DDDR and Vita 2 SSIR 101

4.3 Notes for Section 4.1 - 4.2 108

4.4 Programming the Selection AFm 902, Diamond,

4.5 Programming the Vita DDDR, Vita DDD

4.6 Notes for Section 4.4 - 4.5 151

Medtronic applications 86

head magnet 87

Diamond 3, Ruby 3, Topaz 3 and Jade 3 90

Diamond II,Ruby II, Topaz II and Jade II 134

and Vita VVIR 144

5. Appendices 177

5.1 Emergency operation 177

5.1.1 Emergency programming during follow-up 177

5.1.2 Emergency programming in the Vitatron desktop 178

5.1.3 Emergency settings 178

5.2 Adjusting programmer settings 181

5.2.1. Setting programmer preferences 181

5.2.2 Adjusting time and date 182

5.2.3 Checking software release numbers 183

5.2.4 Memory contents file 183

5.3 Display messages 184

5.3.1 Error message 185

5.3.2 Application messages 186

5.3.3 New or changed application messages 187

Programming Guide

1. Introduction

This manual describes Vitatron software models VSA02 version 9.1 (for the 9790c programmer) and VSC02 version 9.1 (for the Vitatron CareLink programmer). These support the following pacemakers*:

Clarity DDDR and Clarity SSIR Diamond, Diamond II and Diamond 3 Ruby II and Ruby 3 Topaz II and Topaz 3 Jade II and Jade 3 Vita DDDR and Vita 2 DDDR Vita DDD Vita VVIR and Vita 2 SSIR Selection AFm 902** Visa DR, Visa D, Visa SR and Visa S Legacy II D, Legacy DR and Legacy II DR Legacy II S and Legacy II SR Legacy D Legacy SR Atrial and Legacy SR Ventricular Legacy S Atrial and Legacy S Ventricular

*Note:

For programming details on Legacy and Visa pacemakers, refer to the applicable technical manual and programming guide.

**Caution: After the first interrogation with the 9.0 or 9.1 version of the Vitatron software VSA02 or VSC02, the Selection AFm 902 pacemaker is no longer compatible with VSA02 or VSC02 releases before 9.0.

For further technical data and programming details on the pacemakers listed above, refer to the relevant product information manual delivered with the pacemaker.

3Programming Guide

Introduction

Some application messages may differ from the messages described in the Product Information Manual that was delivered with the pacemaker. Please refer to section 5.3.3 for an overview of new and changed messages.

Note:

This Programming Guide describes how to use either a Medtronic/ Vitatron 9790c or Vitatron CareLink programmer (further referred to as the programmer) with Vitatron pacemakers. This is possible provided a programming head is connected and the appropriate software is installed. For technical information about the programmer itself, please refer to the documentation that was provided with it.

Programming Guide

2. The screen layout

In this section, the Vitatron desktop is discussed. This is the first screen that appears after start-up, provided Vitatron software was used during the last patient follow-up.

In addition, the general screen layout is explained and the menu options available during a follow-up or tutorial session are discussed. In some applications, the screens may look slightly different but they will have a structure similar to that described below.

2.1 The Vitatron desktop

After setting up the programmer and switching it on, the Vitatron logo appears briefly during start-up (provided that a Vitatron application was last used during the previous follow-up). This is followed by the Vitatron desktop, shown below:

The top line shows the Vitatron logo. The control panel (see section

2.2.) contains three icons: Select Model, Programmer and (if installed) Analyzer.

5Programming Guide

2.1 The Vitatron desktop

Under Programmer you can adjust the programmer preferences, change date and time in the programmer, retrieve software information or access memory contents files. See Appendix 5.2.

Pressing Select Model activates the Vitatron desktop and allows you to choose between tutorial sessions for dual chamber, single chamber or Selection series pacemakers or to launch other (future) applications. Note that Select Model is always active after start-up.

The bottom line normally contains two buttons: Auto-Identify and

Vitatron > Medtronic.

[Auto Identify] Pressing this button starts automatic recognition and interrogation of the pacemaker.

[Vitatron to Medtronic] Used to go from Vitatron to Medtronic applications.

If the Medtronic lead analysis software and hardware are installed on the programmer, the Vitatron desktop will contain the Analyzer icon. Clicking it will start the analyzer program. After ending the analyzer program the programmer will restart the Vitatron desktop. For more information about the analyzer please refer to the documentation provided with it.

6 Programming Guide

2.2 General screen layout

The Vitatron software screens have the following general layout:

2.2 General screen layout

Top line

ECG area

Control panel

Button line

Main window

Top line

The top line always shows the Vitatron logo and, if applicable, the name of the pacemaker being programmed or interrogated, as well as the programmed pacing mode.

Note:

When using a Vitatron CareLink programmer a 'task bar' is visible above the top line of the display. The functions included in this task bar are described in the Medtronic/Vitatron CareLink Programmer Reference Guide, which is provided with the programmer.

ECG area

In this area, the patient's ECG is displayed, provided the ECG leads are attached and the ECG function is switched on (see section 3.2.).

ECG control area

This area contains the Adjust button which you can use to change ECG settings (see section 3.2.).

Main window

This area shows all screens pertaining to the currently active application.

7Programming Guide

2.2 General screen layout

Control panel

In the control panel you will find icons that represent various submenus: Data, Parameters, Tests, Patient, Reports.

Button line

General push buttons, such as Emergency and End Session,are positioned in the button line at the bottom of the display.

Programming Guide

2.3 Menu options

During tutorial sessions or follow-ups you can select certain menu options. These are explained below.

Data

The Data menu enables you to retrieve the Status screen. Also, it provides Holter and Histogram selection and read-out options, as well as data from the Counters function and Battery and Lead Measurements.

Parameters

The Parameters menu allows permanent or temporary programming of parameters and functions.

Tests

In the Tests menu you can measure pacing thresholds, perform sens- ing tests and VA or QT interval tests, initiate Fast Learn procedure, start AOO Burst Pacing and turn ECG markers on or off, if applicable.

2.3 Menu options

Patient

The Patient menu is used to enter patient and pacing system data into the pacemaker.

Reports

With Reports you can make a printout of various items, such as status list and measurements. You can also save pacemaker data onto a

3.5 inch diskette.

Press the appropriate icon to access the desired menu.

9Programming Guide

2.4 Vitatron tutorial

2.4 Vitatron desktop tutorial

On completion of start-up, the Vitatron desktop is shown. From here you can activate tutorial sessions that allow you to familiarize yourself with programming procedures.

> To start a tutorial, select the desired model group from the list at the

top of the screen. Then select the desired pacemaker and press Demo in the Vitatron desktop.

A Clarity DDDR tutorial is explained below.

> Select Clarity DDDR and press the Demo button. The status screen is

displayed.

Programming Guide

2.4 Vitatron tutorial

Note:

The Status screen appears at the start of a follow-up. It can be recalled at a later stage of the programming session by pressing the Data icon and selecting Status. See section 3.6.1.

The Status screen shows the main parameters and their programmed values, measurement data, and results from counters if applicable. It is not possible to change values in this screen. To leave this screen, press the 'close' button (see below).

Close button

The top right corner of each menu contains a 'close' button. On pressing this button in the status screen, the window disappears and the programmer displays the main menu screen shown below.

11Programming Guide

2.4 Vitatron tutorial

Note:

To enter any other screen directly, without using the 'close' button, you can select the appropriate icon while the programmer is still displaying the current menu screen.

This way of going from one screen to another directly is possible in all menus. However, boxed values must first be programmed or cancelled. The main menu screen shows several icons in the control panel on the right, each representing a submenu with pacemaker programming and interrogation options.

During a follow-up, the Cancel Magnet/Activate Magnet button at the bottom of the screen switches the magnet mode off or on respectively. At the top of the screen you can check during the follow-up whether the magnet is active or inactive (see section 3.17).

> Now press the Parameters icon to open the Parameters Therapy menu.

12 Programming Guide

2.4 Vitatron tutorial

The programmer displays the programmed value of each parameter in a highlighted box to its right.

> Press the value box for ventricular amplitude.

The currently programmed parameter value is indicated by means of a boxed P to the right of that value.

> Select 2.5 V by pressing with the touch pen on the value 2.5.

The value selection window disappears and a dark border around the value box indicates that the value is pending.

13Programming Guide

2.4 Vitatron tutorial

Note:

If on opening the value selection window for a certain parameter you decide not to select a new value, press outside the value selection window to close it without changing anything.

Programming Night Rate Drop provides another example of a value selection window appearing on the display. The > symbol at the right of the value box indicates that on pressing this value box, a submenu appears on the display.

> Press the Night Rate Drop value box.

14 Programming Guide

2.4 Vitatron tutorial

> Press the left End Night value box.

> Press the upward-pointing arrow displayed on the right of the End

Night time to select an End Night time of 7.00. Then press the Night Rate Drop value box and press 10 in the list of options that is subsequently displayed.

> Press the OK button to return to the Parameters Therapy screen.

Pressing Cancel takes you back to the Parameters Therapy screen without selecting new values.

Now both Night Rate Drop and Ventricular Amplitude have pending values, as indicated by the dark border around the value box.

15Programming Guide

2.4 Vitatron tutorial

> You can program the pending values by pressing the Program button

(you can return to the currently programmed settings by pressing the Undo Pending button).

Upon pressing Program you will see the dark borders around the pend- ing values disappear, which means they have been permanently programmed. Refer to section 3.13 for information on temporary programming.

> To program the parameters to nominal values, press Nominals... first.

Selecting the first option, Standard Settings, programs the pacemaker to the delivery settings defined by Vitatron and mentioned in the applicable Product Information manual delivered with the pacemaker concerned.

The second option, Setting at Start of Session, resets all parameters changed so far to the values that were in effect at the start of this tutorial.

> Press Setting at Start of Session, then OK. The programmer shows all

parameter values boxed indicating that they are pending. For permanent programming of these settings, press the Program button.

This completes programming the tutorial pacemaker back to its settings at the start of the session.

16 Programming Guide

2.4 Vitatron tutorial

> Press the Reports icon. > Press the selection box for Print Selection. A list from which you can

select items for printing now appears.

> Select Status list and Histogram by selecting the appropriate boxes. > Press Print Preview.

Pressing Print Preview will show what the printout is going to look like. You can view text which does not fit on one window by scrolling through it. See section 2.5 for an explanation of the scrolling technique.

> Press OK to leave the Print Preview window.

17Programming Guide

2.4 Vitatron tutorial

> Now press Print to obtain a printout of the selected items. > Press the 'Close' button to leave the Reports menu. > To end the tutorial session, press the End tutorial button. This takes

you back to the Vitatron desktop.

Emergency

> If you suddenly need to program emergency settings, press the Emer-

gency button on the bottom left of the display. This button is always

active after a pacemaker has been interrogated.

If the programming head is not applied to the pacemaker correctly and the Emergency button is pressed, a message box appears. In a patient follow-up, emergency operation starts as soon as the programming head is correctly positioned over the pacemaker and communication is established.

> In this example, the message disappears after pressing Cancel.

Emergency programming can also be performed by pressing the red Emergency button left of the screen on the display panel. The emergency procedure that is started by pressing this button is the same as described for the on-screen emergency button. More information on the Emergency procedure is presented in Appendix 5.1.

Programming Guide

2.5 Scrolling

Text displayed by the programmer, e.g. histogram or Holter information or a print preview, may be too long to fit in one window. In this case, the programmer displays an activated scroll bar on the right of it. This enables you to scroll through the text. See below for an example of how to use the scrolling technique.

> Press the Reports icon in the main menu, select Print Selection and

then Status List and press Print Preview.

2.5 Scrolling

Scroll button

Scroll box

Scroll shaft

Scroll button

Along the right side of the Print Preview window, a dark grey vertical bar is displayed. This is called the scroll bar. It consists of four parts: the scroll shaft, the scroll box and two scroll buttons. The scroll box can move up and down through the scroll shaft. The scroll box indicates the relative position of the information displayed in the window. If the scroll box is positioned at the top of the scroll shaft, the first part of the available information is shown. If the scroll box is positioned at the bottom of the scroll shaft, the last part of the available information is shown.

Scroll bars may appear vertically, such as the one discussed above, or horizontally. In a horizontal scroll box, you can retrieve all available information by scrolling from left to right.

19Programming Guide

2.5 Scrolling

1. Press scroll buttons

2. Press scroll shaft

There are 3 ways to move the scroll box.

Move the scroll box down through the scroll shaft by pressing the lower scroll button once. Each time the scroll button is pressed, the information displayed moves up one line. Press the lower scroll button again to move up one more line. Repeat this until all information has been displayed.

You may press the upper scroll button to bring information shown earlier back into view.

Press inside the scroll shaft below or above the scroll box. This brings the next or previous screen page into view.

3. Drag the scroll box

Drag the scroll box. Position the tip of the touch pen on the scroll box and then move the pen in the desired direction without taking the pen tip off the screen.

The information displayed in the window moves in and out of view along with the scroll box. Press OK to leave the window.

Programming Guide

3. Follow-up

3.1 Start-up and auto-identify

In this chapter you will find information on how to program and interrogate a Vitatron pacemaker (see the beginning of this Programming Guide for the applicable models). A number of 'How to ...' sections cover the most frequent programmer actions as performed during a patient follow-up.

Figures provide examples of the programmer screen display during a Clarity DDDR follow-up. These screens may look slightly different in sessions with other pacemaker models but will have a similar structure.

21Programming Guide

3.1 Start-up

3.1.1 Start-up

Turn the programmer on using the ON/OFF switch. The Vitatron logo start-up screen appears briefly during start-up, provided Vitatron software has been installed and provided the last follow-up was carried out on a Vitatron pacemaker.

On completion of start-up, the Vitatron desktop is displayed.

If the programmer shows a Medtronic screen layout at start-up, this means that during the last patient follow-up a Medtronic implantable pulse generator was programmed or interrogated. Press the Medtronic to Vitatron switch to enter the Vitatron mode.

The model selection screen features various icons and buttons: Freeze,

Strips, Adjust, Select Model, Programmer, Analyzer(if installed) Start, Demo, Auto-Identify, and the Vitatron to Medtronic switch. For a description of

the Select Model, Programmer and Analyzer functions see chapter 2. For a description of the Freeze and Adjust functions see section 3.2.

Programming Guide

3.1.2 Selecting Auto-Identify

> Press the Auto-Identify button to start the automatic pacemaker recog-

nition procedure.

Note that this procedure does not start unless Auto-Identify is pressed.

If the programming head is not positioned correctly the programmer displays a warning message.

3.1 Start-up

> Position the programming head to continue the automatic model

selection procedure.

For information on correct positioning of the programming head, see the programmer manual. On pressing Cancel the programmer returns to the model selection screen.

Note:

The P (Program) button on the programming head serves as an alternative to the Program command that appears on the display screen. The I (Interrogate) button on the programming head corresponds to the Auto-Identify button on the screen. Both the Interrogate button and the on-screen Auto-Identify button can be used to start the automatic pacemaker recognition procedure.

For convenience, you may press the Interrogate or Program button on the programming head instead of selecting the corresponding option from the display.

23Programming Guide

3.1 Start-up

Program

Interrogate

Upon completion of the automatic pacemaker recognition procedure, the programmer displays the status window showing the main parameters of the recognized pacemaker. The pacemaker model is displayed at the top of the screen.

Note:

You cannot program parameters in this window. Press the Parameters icon to change parameter values and to select options. You may also press one of the other icons to perform any of the related programmer actions. Press the Print button to obtain a printout of the status window.

Programming Guide

3.1 Start-up

Auto identify unsuccessful

If the programmer recognizes the pacemaker as being a Vitatron model, but cannot interrogate or program it a message to this effect will appear. It could be that a software upgrade is needed. In such cases it is always recommended that you contact your Vitatron representative

If the pacemaker is a Medtronic model, you must press the Vitatron to Medtronic switch in the bottom right corner of the screen to enter Medtronic applications.

If during a patient follow-up the programming head is applied to a different pacemaker, the programmer will restart the automatic pacemaker recognition procedure.

25Programming Guide

3.2 How to use the built-in ECG recorder

This section contains information on using the built-in ECG recorder. For instructions on attaching the ECG cable and connecting the ECG leads please refer to the programmer manual.

3.2.1 Using the ECG in the Vitatron desktop

When you switch the programmer on and the Vitatron desktop appears the displayed ECG options and the ECG layout differ slightly from those that are presented once a pacemaker has been interrogated. Although the desktop options are not described extensively in this manual, the main difference is that in the Vitatron desktop it is possible to freeze and display the last 15 seconds of the displayed ECG and subsequently analyze it using on-screen calipers. The control buttons control the frozen ECG viewing window by letting you move each of the two vertical cursors appearing in the window to any desired position. The cursors thus act as calipers allowing you to measure the time interval between events. The caliper measurement is displayed in milliseconds in the upper-left corner of the window.

The ECG can be displayed in a minimised format, in which only one lead is displayed in the ECG window at the top of the screen. It can also be displayed in a full screen format, in which all three leads are displayed simultaneously. In the top right corner of the ECG window, a square push button is displayed to switch from one ECG format to the other.

Programming Guide

3.2 How to use the built-in ECG recorder

The ECG window is automatically opened in its minimized format when the programmer is switched on.

3.2.2 Using the ECG during follow-up

Once a pacemaker has been interrogated the ECG function can be switched OFF and ON in the Adjust ECG menu.

> To open this menu, press the Adjust button on the right of the screen.

As long as the Adjust ECG window is opened, the ECG is displayed in the full screen format.

27Programming Guide

3.2 How to use the built-in ECG recorder

The Adjust ECG menu also includes the following parameters:

Top line, Sweep speed, Filter, Amplitude, Artifact Display, Artifact Level and Artifact Lead.

Below is an explanation of how to adjust these settings:

Top line

You can select ECG lead I, II, or III. If the ECG is shown in the minimized format, the selected lead is the only one displayed. If the ECG is shown in the full screen format, the selected lead is displayed on top, and the other two leads are displayed below.

Sweep speed

The Sweep speed option controls the sweep speed of the on-screen ECG recorder, expressed in mm/s. Available values are 12.5, 25, 50, and 100 mm/s.

Filter

The Filter function controls the filtering of ECG signals by switching between two different band widths. Filter ON: bandwidth is 0.5 to 40 Hz Filter OFF: bandwidth is 0.005 to 100 Hz

With the Filter switched on, clarity of the displayed and printed ECG may be improved in the presence of interference.

Programming Guide

3.2 How to use the built-in ECG recorder

> To adjust the Filter setting, open the appropriate value box by pressing

it with the touch pen.

> Press ON.

The value selection window closes, which indicates that your selection has been accepted. Filter is now switched on. This change takes effect immediately.

> Press OK to close the Adjust ECG window. The ECG is displayed in the

format it was in before adjusting. The Filter setting can also be adjusted during ECG printing. The adjustment takes effect immediately. In a similar way you can adjust the other ECG settings described below.

Amplitude

The Amplitude option determines the size of all displayed ECG traces. Available values range from 0.05 mV/mm to 1.0 mV/mm. The amplitude setting selected for the ECG signal applies to the printed ECG trace as well.

Artifact Display

The programmer translates detected atrial or ventricular pacing pulses into artifacts which are represented as vertical spikes in the ECG window and on the ECG printout. These artifacts are also trans-

29Programming Guide

3.2 How to use the built-in ECG recorder

ferred to the analog output for viewing on an external ECG monitor or recorder. The Artifact Display function can be turned ON or OFF. Below it is explained how you can select an ECG lead for detection of pacing pulses and how you can set the sensitivity level.

Artifact Level

This option controls the ECG system's sensitivity regarding the detection of pacing pulses. In order to prevent interference signals being interpreted as pacing pulses or certain pacing pulses not being detected, you should select the appropriate Artifact Level.

The available ranges for the Vitatron CareLink and 9790c are: Vitatron CareLink - From 1 (very sensitive) to 5 (very insensitive). 9790c - From 1 (very sensitive) to 8 (very insensitive). Also available is an 'auto' setting in which the programmer automatically varies its Artifact Level between 5 and 8 to ensure optimal artifact display.

The required Artifact Level may vary due to the amount of electromagnetic interference (EMI) present at the follow-up site.

Programming Guide

3.2 How to use the built-in ECG recorder

Artifact Lead

This option determines which ECG lead is used to detect pacing pulses. During programming or interrogation of the pacemaker, communication signals may appears as artifacts on the ECG. Turn Artifact Display off or adjust Artifact level.

Print ECG

> To print the ECG by means of the built-in strip printer, press one of

the printer control buttons on the left of the programmer.

This will start printing of all three ECG traces at a speed of 12.5, 25 or 50 mm/s (the latter is only available in the Vitatron CareLink programmer).

The printing speed is indicated once, at the start of the printout. During printing, a new printing speed can be selected. This change takes effect immediately and is indicated on the printout by means of vertical dashed line. The new printing speed is printed as well.

ECG Markers are only shown if this function is switched on (see section 3.14).

> To stop printing, press the printer control button that represents the

selected printing speed, again.

31Programming Guide

3.2 How to use the built-in ECG recorder

If the printer is out of paper, the programmer displays a message saying so. Press Cancel to cancel printing or press OK after you have installed printer paper to continue printing.

ECG calibration

The calibration button is positioned next to the analog output on the right of the 9790c programmer and on the analog I/O box that is provided with the Vitatron CareLink programmer. Pressing the calibration button initiates two calibration signals, one for the ECG leads and one for the ECG Markers.

The calibration signal for the ECG leads consists of two pulses with an amplitude of 1 and 5 mV respectively. The calibration signal for the ECG Markers consists of 8 pulses referring to amplitude levels -4 to +4, each representing a different amplitude. These calibration signals appear on the printed and displayed ECG and Marker Channel and are transferred to the external ECG recorder if connected. You may use the signals to analyze the ECG and ECG Marker amplitudes by comparing those to the height of the applicable calibration signal.

Warning:

This programmer is designed for monitoring purposes only. It is not intended for independent diagnostic use. Only use the programmer with surface electrodes.

Programming Guide

3.2 How to use the built-in ECG recorder

Invalid ECG

If the ECG cannot be displayed on the screen fast enough, the data displayed becomes invalid. The programmer will indicate this problem with the following on-screen warning: 'ECG screen data has become

invalid. Press OK to restart proper ECG display.'

As long as this message appears on the programmer screen, ECG display is stopped and no new data is shown. Press OK to clear the current (invalid) ECG and start a new one.

33Programming Guide

3.3 How to program a parameter

This section explains how a parameter can be programmed to a new value. It deals with parameter programming, batch programming and nominal programming.

3.3.1 Parameter programming

> Press the Parameters icon.

In the Parameters therapy screen, parameters can be selected for programming.

> To select a parameter, e.g. ventricular amplitude, press the parameter

value box, i.e. the highlighted window next to the parameter.

Programming Guide

3.3 How to program a parameter

The currently programmed value, 3.8 V, is indicated by means of a boxed 'P' to the right of that value.

> Select a new value, e.g. 2.5 V.

The ventricular amplitude value box now appears boxed to indicate that 2.5 V is a pending value that can be programmed.

> To program the new parameter value, press the Program button in the

bottom right corner of the Parameters Therapy screen.

35Programming Guide

3.3 How to program a parameter

Programming will start immediately provided the programming head is applied to the pacemaker correctly. If this is not the case, the programmer will display a warning asking you to reposition the programming head. Programming can also be performed by pressing the P button on the programming head.

Program

Interrogate (Auto-Identity)

When the new parameter value has been programmed, the box around the pending value disappears.

Pressing Undo Pending instead of Program returns the pending parame- ters to their currently programmed values.

If you open a value selection window and you decide not to select a new value, you can press outside the window to close it. Pressing a different parameter value box also closes the one currently opened, and opens the corresponding parameter selection window.

Some parameter value windows display a > character on the right, indicating that pressing this window opens up a submenu with programmable parameters, e.g. the Night Rate Drop window.

3.3.2 Parameter pertinency

Only those parameter values that are applicable to the selected mode, e.g. atrial amplitude in the AAIR mode, are shown on the programmer display. This is called parameter pertinency.

Example

Suppose, with the pacemaker in the DDD mode, the atrial amplitude

Programming Guide

3.3 How to program a parameter

is to be reprogrammed from 3.8 V to 2.5 V. The new value is boxed to indicate that it is pending. If the mode is now changed to VVI, the boxed atrial value of 2.5 V is cleared. Pressing Program now results in permanent programming of both the VVI mode and the pending value for atrial amplitude, 2.5 V. If the pacemaker is subsequently reprogrammed to a dual chamber mode, the atrial pulse amplitude will be 2.5 V. You can simulate this example in a tutorial session. See section 1.5.

Warning:

If you select a new value for a certain parameter without yet programming it, this pending value disappears from the programmer screen after selecting a new mode to which the parameter concerned is not pertinent. However, it is still pending and will be permanently programmed after you press the Program button. To prevent this situation, press Undo Pending first, then select a new mode.

3.3.3 Batch programming

It is also possible to program several parameters (or features) in one programming action.

> In order to perform batch programming, select a new value for each

parameter/feature that you wish to program, one after the other. All changed (pending) parameter values appear boxed on the screen.

37Programming Guide

3.3 How to program a parameter

> Now press Program to enter the new values into the pacemaker per-

manently. The boxed values are unboxed, which indicates the corresponding parameter has been changed.

Pressing Undo Pending instead of Program returns all pending parame- ters to their currently programmed values.

3.3.4 Nominal programming

A special kind of batch programming is used to change all parameters, if applicable, to nominal settings. Nominal settings can be either the settings at the start of the session or the standard settings defined by Vitatron.

> For nominal programming, press the Nominals button on the bottom

left of the Parameters Therapy screen. Then choose between 'Standard Setting' and 'Setting at Start of Session' and press OK.

All parameters are boxed showing new values if applicable.

> Now press Program to change all parameters to nominal settings.

The pending values are now unboxed, indicating they have either been successfully programmed into the pacemaker. Pressing Undo Pending returns all pending parameters to their currently programmed values.

Programming Guide

3.3 How to program a parameter

Note:

If one or more parameters are still pending and you either press the 'close' button in the top right corner of the screen or try to open another screen, a warning appears asking you to either program or cancel the pending values. Press OK to continue.

Warning:

Pacemaker programming should be done only after careful study of the Product Information manual enclosed with the pacemaker and determination of the appropriate parameter settings. Improper use of the programmer could result in erroneous or inadvertent programming and improper operation of the telemetry and measurement functions.

Warning:

If power to the programmer is unexpectedly lost, lifting the programming head away from the patient's pacemaker cancels any temporary parameters or functions in effect and restores the pacemaker to its permanently programmed state. Loss of power during permanent programming of one parameter cancels the programming action. After the programmer is turned back on and the appropriate application is started, the programming action must be started again.

Warning:

If power is lost during permanent programming of batched parameters, all parameters that had already been reprogrammed before the power loss keep their new value. All other parameters, including the one being repro-

39Programming Guide

3.3 How to program a parameter

grammed at the moment that power is lost, keep the values they had before the batch programming action was started. After the programmer is turned back on and the appropriate application is started, the programming action must be performed again for those remaining parameters. If power is lost during a follow-up, the nominal values of Setting at Start of Session are lost too. After restarting the programmer, the data obtained through the initial interrogation procedure constitutes the new nominal values of Setting at Start of Session.

Programming Guide

3.3.5 Additional programming for the Selection AFm 902

How to program Ventricular Rate Stabilization

Press the Parameters icon in the Main Menu screen to open the Parameters Therapy screen.

3.3 How to program a parameter

Ventricular Rate Stabilization (V. Rate Stabil.) and the parameters maximum AFtherapy rate (Max Therapy) and AF deceleration are listed under the heading 'AF Therapy'. They can be programmed by pressing the appropriate value box in the Parameters Therapy screen.

Notes:

1. In the event of a power failure or interruption while parameter

programming is in progress, Ventricular Rate Stabilization will be programmed OFF.

2. If the mode is changed from DDD(R) or VVI(R) to any other mode

while Ventricular Rate Stabilization is ON, Ventricular Rate Stabilization will be programmed OFF.

41Programming Guide

3.4 How to measure pacing thresholds

> To perform an atrial or ventricular pacing threshold measurement,

press the Tests icon in the main menu screen.

> Select the Pacing Threshold option.

> Select one of the options shown on the left, e.g. A Amplitude and then

press the touch pen on Press and Hold and keep it pressed there to perform the measurement.

Programming Guide

3.4 How to measure pacing thresholds

The programming head must be applied to the pacemaker correctly and continuously. Note that measurements can be performed independent of the programmed mode. In a dual chamber model for instance, you can measure the pacing threshold for atrial amplitude while the pacemaker is programmed to a ventricular mode.

> Watch the ECG carefully, either on the programmer display or an ex-

ternal ECG monitor. On loss of capture, release the Press and Hold button to stop measuring.

The pacemaker returns to its permanently programmed settings.

Unless you release the Press and Hold button or remove the programming head, the programmer will continue to pace at decreasing atrial amplitudes in a step-down cycle until it reaches the minimum value. On completion of the measurement, the pacemaker returns to its programmed settings.

The threshold value is displayed under Results in the middle of the screen. At the bottom of the screen, in the Parameter Setting window, you can program the pacemaker to a new atrial amplitude duration based on the outcome of the test as you consider appropriate. Also, you can program new values for parameters such as atrial pulse duration or atrial pace polarity to perform the test again. See section 3.3 for general information on the programming of parameters.

If the Parameter Setting window contains boxed parameters, measuring pacing thresholds is not possible. Press Program or Undo Pending first, then start the measurement.

In the same way, you can perform a threshold test for ventricular amplitude, and atrial or ventricular pulse duration, if applicable. These parameters can also be programmed to a new value in the Parameter Setting window.

Print and Print Preview

Between measurements, you can press the Print Preview button to retrieve the measurement list. This list can be printed by touching the Print button.

43Programming Guide

3.4 How to measure pacing thresholds

See section 3.10 for further information on Print and Print Preview.

Note:

For the sake of pacing threshold measurements, you may have programmed new values for atrial or ventricular amplitude or pulse duration in the Parameter Setting window. Note that these are permanent parameter values. Determine whether they are appropriate for the patient. If necessary, program new values that provide an adequate safety margin.

> You can leave the Pacing Threshold window by pressing the 'close'

button in the top right corner or by clicking one of the other icons in the control panel on the right, which subsequently opens the corresponding menu.

Programming Guide

3.5 How to perform a sensing test

> To measure amplitudes, press the Tests icon in the main menu screen.

3.5 How to perform a sensing test

From the options displayed, select Sensing Test.

> Select one of the options displayed on the left, e.g. P-Wave Amplitude,

by pressing the appropriate selection box.

> Press Start to begin the sensing test.

The programming head must be applied to the pacemaker correctly and continuously.

45Programming Guide

3.5 How to perform a sensing test

Note that measurements can be performed independent of the programmed mode. In a dual chamber model for instance, you can test P-wave amplitude while the pacemaker is programmed to a ventricular mode. However, you can not change the atrial sensitivity and atrial polarity during the test.

> Prior to and during the test, you can adjust the pacing rate. Press the

rate value box and then press the appropriate up or down arrow.

For R-wave amplitude measurements the AV delay can also be adjusted prior to, but not during the test. Alternatively, the pacemaker can be temporarily reprogrammed to the VVI mode.

On completion of the test, the measured amplitude is displayed under Results. In the Permanent Setting window at the bottom of the screen, you can program atrial or ventricular sensitivity to new values that you consider appropriate on the basis of the test results. To stop the test before it is completed, press Stop. After the test is stopped, the temporary rate at which the test was performed remains visible. However, the pacemaker resumes normal operation at the programmed rate on completion of the test.

Note:

If the Permanent Setting window contains boxed values, measuring amplitudes is not possible. Press Program or Undo Pending first, then press Start to begin the test.

Print and Print Preview

Between measurements, you can press the Print Preview button to retrieve the measurement list. This list can be printed by pressing the Print button. See section 3.10 for further information.

Note:

For the sake of the sensing test, you may have programmed new sensitivity in the Parameter Setting window. Note that these are permanent parameter values. Determine whether they are appropriate for the patient. If necessary, program new values that provide an adequate safety margin.

Programming Guide

3.5 How to perform a sensing test

> You can leave the Sensing Test window by pressing the 'close' button

in the top right corner or by clicking one of the other icons in the control panel on the right, which subsequently opens the corresponding menu.

47Programming Guide

3.6 How to retrieve data

During interrogation of a pacemaker all counters, histograms and Holters can be read out. The contents of the counters and histograms are then cleared and the information is subsequently retained in the programmer memory until the programming session is ended. If you want to save information from histograms and counters it must be printed out before ending the programming session. The information will otherwise be lost.

> Press the Data icon to gain access to the status screen and to other

data, which may include Histograms, Holters, Mode Switching Trend, Selected Events, Set Diagnostics, Counters and Battery and Lead Measurements. An [i] following the listed feature indicates that it has already been read out during initial interrogation of the pacemaker.

Programming Guide

3.6.1 Status and diagnostic observations

> Select status to open the status screen.

3.6 How to retrieve data

This screen shows the main parameters and their programmed values. It is not possible to change values here. To change a value or option, press the Parameters icon in the control panel on the right (see section 3.3.1).

> Press the Print button to obtain a printout of the status list.

The status screen also contains a Diagnostic Observations window. This function is only active if the implantation date has been entered (see section 3.12).

> Select a message in the Diagnostic Observations window and press

'View Event'. The selected message is explained and suggestions are given on how you may optimize settings.

49Programming Guide

3.6 How to retrieve data

Warning:

'Diagnostic observations' can never replace expert judgement.

Notes:

1. To print the information shown on the screen return to the status

screen and press 'Print Event'.

2. Press the 'close' button to return to the status screen.

The Counters button in the bottom left corner enables you to retrieve the results from Counters (see section 3.8.).

3.6.2 Histograms

> To retrieve histograms, press the Data icon on the right of the screen.

A list of options is displayed, including the active histogram(s). In Clarity DDDR pacemakers, for example, the P-wave amplitude histogram and the atrial rate histogram are always active in atrial sensing modes. At the start of each session, all fixed histogram information collected since the last follow-up is automatically transmitted to the programmer during interrogation of the pacemaker. To retrieve it press the applicable option in the Data window

Programming Guide

> Select the P-wave amplitude histogram.

The programmer warns you if no information is available.

3.6 How to retrieve data

> Press the Print button to print the information shown on the screen.

Press the 'close' button in the top right corner to leave the P-wave amplitude histogram window.

In addition to the fixed histograms, one extra histogram can be programmed. For instructions on how to program a certain histogram, see 3.7.1. The pacemaker will have gathered data for the programmed histogram type since the last follow-up or since the histogram was last programmed.

> The histogram data can be displayed by pressing the applicable option

in the Data submenu.

51Programming Guide

3.6 How to retrieve data

The programmer warns you if no information is available.

> Press the Print button to print the information shown on the screen. If

the histogram has been reprogrammed and you want to read the histogram data, press Read. Press the 'close' button in the top right corner to leave the Histogram window.

During follow-up, a new type of histogram can be programmed. This new histogram will be listed in the Data submenu. If you had already retrieved the data for the previously programmed histogram from the pacemaker, this histogram will remain listed as an available option in the Data submenu. It is marked with [i] meaning that the data for that Histogram has been interrogated.The new programmed histogram type is listed without a symbol. However, if you are going to view data for the new histogram on the screen, note that all data gathered for the previously programmed histogram is deleted. The programmer displays a warning in this case.

First, press Print in the applicable histogram window to obtain a printout of all data gathered for the previously programmed histogram. Then press Read in the applicable Histogram window to retrieve data on the new type of histogram from the pacemaker. Press the Print button to obtain a printout of the data. Press the 'close' button in the top right corner to leave the Histogram window.

Programming Guide

If you open the Data submenu now, you will notice that the newly programmed histogram is marked with [i] meaning this is the interrogated histogram now present in the programmer memory. The previously programmed histogram type has disappeared from the list.

3.6.3 Holters

At the start of each session, all Holter information collected since the last follow-up is automatically transmitted to the programmer during interrogation of the pacemaker.

> To retrieve Holter information, press the Data icon in the main screen.

From the list of options, select the programmed Holter. The Holter information is now retrieved and displayed.

3.6 How to retrieve data

The programmer warns you if no information is available.

> Press Read to retrieve data for the programmed Holter. Press the Print

button to obtain a printout. Press the 'close' button in the top right corner to leave the Holter window.

53Programming Guide

3.6 How to retrieve data

During the session, a new type of Holter can be programmed. This new Holter will be listed in the Data submenu. If you had already retrieved the data for the previously programmed Holter from the pacemaker, this Holter remains listed in the Data submenu. It is marked [i], which means that the data has been retrieved from the pacemaker. The newly programmed Holter is listed without a symbol. However, if you are going to view data from the new Holter on the screen, Note that all data gathered for the previously programmed Holter type will be deleted. The programmer displays a warning in this case.

Press Print in the applicable Holter window first to print out the data gathered for the previously programmed Holter. Then press Read in the applicable Holter window to retrieve data on the new type of Holter from the pacemaker. Press the Print button to obtain all data on a paper printout. Press the 'close' button in the top right corner to leave the Holter window. If you open the Data submenu now, you will notice that the newly programmed Holter is marked with [i], which means that this is the interrogated Holter now present in the programmer memory. The previously programmed Holter has disappeared from the list.

3.6.4 Mode Switching Trend

> To retrieve information on the Mode Switching Trend, select this

option from the Data submenu (see section 3.6). The display shows you a diary (cause, duration and date) of long mode switches, number of short mode switches and percentage 'fast resynchronization'. A vertical scroll bar allows you to scroll through the diary. Press Read to update the information on selected events (events that may have occurred since the start of follow-up). Press Print to obtain a printout.

Programming Guide

3.6.5 Selected Event Recording

> To view Selected Events, select this option from the Data submenu

(see section 3.6). The display shows a 'Diary' containing the storage period and number of episodes of the selected events.

3.6 How to retrieve data

Press View Report to preview the selected episode (rate profile diagram or marker ECG diagram). A scroll bar allows you to scroll through the selected episode.

55Programming Guide

3.6 How to retrieve data

Press Read to add information that may have been collected since the pacemaker was last interrogated. Press Print Report to obtain a printout.

All collected events can be removed from the pacemaker and programmer memory by pressing the 'Clear Events' button. Use the 'close' button in the top right-hand corner to leave the window.

Note:

The markers used for marker ECG are the same as those used for the ECG event markers (see 3.14).

Programming Guide

3.7 How to set Diagnostic Features

> To set Diagnostic Features press the Data icon in the main menu and

then select 'Set Diagnostics'. A submenu showing the current settings for Histograms, Holters, Mode Switching Trend and Selected Event Recording is now shown.

3.7 How to set Diagnostic Features

3.7.1 Histograms or Holters

> To activate a certain histogram, e.g. 'PVC vs Time of Day', press the

relevant value box.

57Programming Guide

3.7 How to set Diagnostic Features

> Select 'PVC vs Time of Day' with the touch pen.

The histogram value box is now boxed to indicate a new pending value.

> Press Program to activate this histogram in the pacemaker.

You can program a new Holter by following the same procedure.

3.7.2 Mode Switching Trend

> To activate the Mode Switching Trend, press the relevant value box.

Programming Guide

> Select the desired setting and press Program to send the instruction to

the pacemaker.

3.7.3 Selected Events

> To set Selected Events, press the relevant value box.

3.7 How to set Diagnostic Features

Select the desired settings and press OK. Then press Program to send the instruction to the pacemaker.

3.7.4 Additional Diagnostics for the Selection AFm 902

How to program diagnostic parameters

To program additional diagnostic parameters for the Selection AFm 902, press the Data icon in the main menu screen first. The Data submenu is displayed.

59Programming Guide

3.7 How to set Diagnostic Features

Next, select Set Diagnostics from the Data submenu. This opens the Set Diagnostics menu. In this menu you can program histogram and Holter types, and atrial arrhythmia recording parameters.

How to program atrial arrhythmia recording parameters

Pressing the arrhythmia recording value box in the Set Diagnostics menu will open the atrial arrhythmia recording menu. In this menu the programmable parameters are listed.

Programming Guide

3.7 How to set Diagnostic Features

To program a parameter, for instance the detailed onset reports, press its value box and select the preferred setting. You can choose the total number of detailed onset reports that will be stored (horizontal axis), and how they will be divided into 'first' and 'last' reports (vertical axis). For example, selecting '2+6' means that a maximum number of 8 detailed onset reports will be stored, divided into the first 2 and the last 6.

After having selected the preferred setting, the atrial arrhythmia recording menu is revealed again. Select the other parameters in a similar way. When all atrial arrhythmia recording parameters have the preferred settings, click on OK. Now the Set Diagnostics menu reappears. Press Program if you want to program the new settings. Select Undo Pending to keep the currently programmed settings.

61Programming Guide

3.7 How to set Diagnostic Features

How to retrieve atrial arrhythmia recording data

To retrieve the atrial arrhythmia recording data select this option in the Data submenu. This starts the interrogation of the atrial arrhythmia recording data from the pacemaker. When the interrogation is completed, the data is displayed on the screen.

If the atrial arrhythmia recording data has been interrogated during the same session already, this is indicated with the symbol [i]. In that case, selecting arrhythmia recording in the Data submenu displays the data retrieved.

Programming Guide

3.7 How to set Diagnostic Features

The atrial arrhythmia recording data screen consists of three parts:

1. A Summary section listing the main atrial arrhythmia counter data.

2. A Reports section with print and print preview options. Check the

appropriate box if you want to include its data in the printout of the Reports section.

3. A Detailed Onset Reports section, also with print and print preview

options. The message 'No detailed onset reports available' appears when no arrhythmia episodes have been recorded.

Press Read All to:

- interrogate all atrial arrhythmia recording data including histograms, counters, arrhythmia diary, and detailed onset reports at once. This is also useful in case you want to save these data on a diskette. Note that the interrogation may take a while;

- update diagnostic data that was interrogated already. This will also load all available detailed onset reports into the programmer's memory.

Press Clear All to clear all atrial arrhythmia recording data. The interrogated data will remain available.

Note:

The Read All and Clear All buttons apply to all atrial arrhythmia recording data. Upon pressing either of these buttons, a warning is displayed, and you are asked to cancel or confirm your choice.

Counters, Histograms and Arrhythmia Diary

You can view the data stored in the counters, histograms and/or arrhythmia diary of the Reports section by checking the appropriate boxes and pressing Print Preview. The Print Preview window contains the data of the selected items, which you can view by scrolling through it from top to bottom. Press Print to obtain a printout of the selected items in the Reports section.

63Programming Guide

3.7 How to set Diagnostic Features

Detailed Onset Report

Select a detailed onset report of which you want to see more data. The dashed line indicates the separation between 'first' and 'last' recorded detailed onset reports. Press Print or Print Preview to start interrogation of the pacemaker. When the interrogation has been completed, the report concerned is marked with the symbol [i].

Pressing Print Preview opens the selected detailed onset report window.

The detailed onset report window consists of three sections that you can view on the screen by scrolling from left to right:

1. Episode information and the rate and PAC trend.

2. The rate profile diagram.

3. The marker ECG diagram.

Press the Print button to print the selected detailed onset report.

Note:

Make sure that the paper supply is sufficient before printing the detailed onset reports.

Programming Guide

3.7 How to set Diagnostic Features

Warning:

All atrial arrhythmia recording data is lost if:

• the pacemaker is reprogrammed to another mode;

• the pacemaker is programmed to standard settings;

• the battery status is 'depleted';

• atrial arrhythmia recording is turned OFF;

• any of the atrial arrhythmia recording parameters is

reprogrammed;

• the Clear All button is pressed and data clearing is confirmed with OK.

All atrial arrhythmia recording data stored in the pacemaker is lost if any of the above mentioned situations occur. However, all interrogated data will still be available until the follow-up is ended, or the Read All button is pressed. In all cases the programmer will display a warning before any data is cleared.

65Programming Guide

3.8 Results from counters

3.8 Results from Counters

> To retrieve results from Counters, press the Data icon in the main

menu screen and then select Counters.

This window displays information collected by the various counters and read out during interrogation of the pacemaker. The counters are divided into three groups, i.e. Events, Atrial Rates and Diagnostic Data. This information provides you with additional patient evaluation tools.

Programming Guide

3.9 Battery and lead data

> In order to retrieve data on battery and lead performance, press the

Data icon in the main menu screen and then select Battery & Lead Measurement.

3.9 Battery and lead data

In the Battery & Lead Measurement window the programmer lists all available data on atrial and ventricular output, if applicable. In addition, the battery status and lead impedance are given in the bottom left corner.

Battery and lead data are obtained during initial interrogation of the pacemaker, which takes place automatically at the start of a follow-up after completion of the automatic pacemaker recognition procedure.

> To repeat the lead measurement, press the Measure button in the top

right corner of the Battery and Lead Measurement window.

67Programming Guide

3.10 How to print pacemaker data

The programmer features a built-in strip printer and can also support an external full size printer. You can select the printer in the Programmer menu (see section 5.2.1). You can print various items, including Status list, Measurements and Holter/histogram data.

You can print all available items, or only items you have selected yourself. In addition, you can print a Pacer Memory Copy in the case of programming difficulties, if the pacemaker behavior cannot be interpreted, or if a pacemaker malfunction is suspected. This enables Vitatron specialists to evaluate the pacemaker status and assist you in the next patient follow-up.

> To print data, press the Reports icon in the main menu. > In the Reports menu you can select Print Options by checking the ap-

propriate box.

After pressing the selection box for Print Selection, a list from which you can select items for printing appears.

> Select the desired items by checking the appropriate boxes.

Programming Guide

3.10 How to print pacemaker data

Print Preview

> Select Print Preview to view all data selected for printing.

They are shown in the same format as they will be printed on paper after selecting Print.

Use the scroll box to view data that do not fit in one Print Preview window. See section 2.5 for an explanation of the scrolling technique.

> Press OK to leave the Print Preview window.

> To start printing, press the Print button on the right.

If the printer runs out of paper while processing a print job, it may not resume printing after you have replaced printer paper. In this case, initiate the same print job again to obtain a complete printout.

Note:

Printing of specific menu-related data can be done from within the applicable menu. For example, a measurements list can be printed by selecting Print in the Pacing Threshold menu.

69Programming Guide

3.11 How to save pacemaker data to diskette

To save follow-up data to a DOS-formatted diskette, first press the Reports icon in the Main Menu screen. Next, press the Save button in the Reports screen to save the data on the inserted diskette. The programmer automatically generates a file name with the date and time.

The saved file contains all data that has been interrogated during that session (programmed parameters, results of measurements, diagnostic data, patient information, etc.). Check the Data Submenu to determine which histograms and Holters have been interrogated. Data saved on diskette from the Selection AFm 902 can be accessed using the Vitatron AFdiscover user software.

Warning:

Make sure only virus-free diskettes are used!

Warning:

Remove the diskette from the disk drive before you turn the programmer OFF after the follow-up session(s). Do not switch the programmer ON when a diskette is inserted in the disk drive.

Warning:

Keep the programming head and any other (electro)magnetic devices away from your diskettes, because such devices may damage the data stored on the diskettes.

Programming Guide

3.12 How to enter patient data

To enter patient data and pacing system information into the pacemaker, press the Patient icon in the main menu.

3.12 How to enter patient data

Patient data

> To enter the patient's name (or code), press the patient value box.

71Programming Guide

3.12 How to enter patient data

You can now enter the patient's name or code, with a maximum of 12 characters, using the on-screen keyboard. When using the Vitatron CareLink programmer you can, if you wish, use the hardware keyboard supplied with the programmer. Please note however that only the characters visible on the screen are available on the external keyboard and that lower case letters will be automatically changed to upper case.

When using the on-screen keyboard:

> Press the appropriate characters in order to select them. Press the

space bar at the bottom for a space.

> Press the backspace key <- in order to delete the last entered charac-

ter (you can also delete characters by selecting them with a sliding movement of the touch pen and then pressing the backspace key).

> Confirm the patient's name or code by pressing the Enter button or

leave the keyboard window without programming a name or code by pressing the Cancel button.

A confirmed name or code is boxed in the Patient value box, indicating that it is pending.

> In order to enter the patient's date of birth, press the appropriate

value boxes. These are subsequently highlighted.

> Select a new date of birth by pressing the up or down arrows behind

Programming Guide

3.12 How to enter patient data

the value boxes.

Dates are given in the following format: YYYY-MM-DD.

> Follow the same procedure to enter the pacemaker implantation date.

New dates are boxed to indicate that they are pending values.

> To enter the indication for pacing, press the indication value box.

> Select the indication appropriate for the patient or select Unspecified.

The programmer boxes the selected indication to indicate it is pending.

> You can also enter additional patient information, e.g. regarding pace-

maker syndrome. Press the appropriate value box.

73Programming Guide

3.12 How to enter patient data

> Now choose between Yes, No or a dash. Press outside the value box to

close it. Follow the same procedure, if necessary, for Angina and VA Conduction.

All new values are boxed to indicate they are pending.

Pacing system information

The programmer automatically displays the pacemaker model name, model number and serial number in the Patient window (see under System). In this menu you can alter the pacemaker time, if necessary, by pressing the up or down arrows. Also, you can enter implantation date(s) for the atrial and/or ventricular lead, if applicable. New values are boxed to indicate they are pending.

Programming Guide

3.12 How to enter patient data

> Press Program to register these settings in the pacemaker.

The programmer will unbox all pending values to indicate they have been successfully programmed. Press Undo Pending to cancel entering patient or pacing system data.

> Press the 'close' button or an icon representing one of the other

menus to close the Patient menu.

75Programming Guide

3.13 How to temporarily program a parameter

Temporary programming can be initiated from the Parameters Therapy window.

> Press the Parameters icon.

> Press the Temp Param ... button at the bottom of the screen to enter

the Temporary Parameters menu.

Note that only those parameters are listed that are applicable to the pacemaker model and available for temporary programming.

Programming Guide

3.13 How to temporarily program a parameter

The Temporary Parameters menu lists the currently programmed values. Pending values in the Parameters Therapy window are not shown in the Temporary Programming parameter value box.

> Press one of the options displayed on the left, e.g. Lower Rate.

The programmer displays the selected parameter and its currently programmed value under Temporary Programming.

> Press the up or down arrows to select a new value.

> Press the Start button to program the Lower Rate value temporarily.

Provided there is a proper communication link between programmer and pacemaker, the pacemaker operates with the adjusted Lower Rate value until the Stop or the Close button is pressed. The temporary parameter value flashes on the display. It can be adjusted to a higher or lower value during temporary operation by pressing the up or down arrow.

> Pressing Stop ends temporary programming but the programmer

remains in the Temporary Programming menu.

On pressing Close temporary programming stops and the programmer returns to the Parameters Therapy screen.

77Programming Guide

3.13 How to temporarily program a parameter

Temporary programming is only possible if the programming head is positioned over the pacemaker correctly. In the case of programming head misalignment, a warning is displayed asking for it to be repositioned.

After the programming head has been positioned correctly, the abovementioned warning disappears.

For information on permanent programming, see section 3.3 of this Programming Guide.

Programming Guide

3.14 How to set ECG markers

The ECG recorder function includes a Marker Channel which shows event markers in the ECG window.

> To access the ECG Markers function, select the Tests icon in the main

menu screen.

3.14 How to set ECG markers

> Select ECG Markers.

The programmer displays an overview of available on-screen event markers and their corresponding printout symbols. Use the scroll box to view symbols that do not fit the Marker information window. See section 2.5 for an explanation of the scrolling technique.

79Programming Guide

3.14 How to set ECG markers

Below is an overview of all ECG marker symbols that can appear on the screen, and of the corresponding graphic symbols that can appear on the ECG printout.

Event ECG symbol Printout symbol

Atrial pace

Atrial sense

Ventricular pace

A P

A S

V P

Ventricular sense

Premature atrial contraction

Atrial tachycardia

Ventricular tachycardia

V S

P A C

T S

V S

T S

80 Programming Guide

3.14 How to set ECG markers

Event ECG symbol Printout symbol

Premature ventricular contraction

V C

T S

Atrial synchronization pace

T-wave sense

Retrograde P-wave

Wenckebach mode

Wenckebach block

A S P

R A S

W A S

W A B

A P

PVC -> Astim

VSP

End of ventricular refractory period

* A

A P

V S P

V R

V P

V R

81Programming Guide

3.14 How to set ECG markers

Start ECG markers

> To start the ECG Markers, press the Start button.

The programmer will now show event markers in the ECG window using the symbols displayed under Marker information. As long as the ECG Markers function is ON, no other programming actions can be performed.

Stop ECG markers

> To stop the ECG Markers, press the Stop button. > Press the 'close' button in the top right corner to leave the ECG mark-

ers menu.

Print ECG markers

> To print ECG markers using the built-in printer, start ECG markers and

then select the desired paper speed using the controls on left of the programmer.

The programmer now provides an ECG printout with two ECG traces at the top and the bottom of the printout and a simultaneous trace marked Marker Channel in the middle.

82 Programming Guide

3.14 How to set ECG markers

> To stop ECG marker printing, press the same printer control button

again.

Display ECG markers using an external ECG recorder

> Connect the external ECG recorder. > Start ECG markers as described above. Event markers are transferred

to the external recorder automatically.

ECG Marker calibration

The calibration button is positioned next to the analog output on the right of the 9790c programmer and on the analog I/O box that is provided with the Vitatron CareLink programmer. Pressing it initiates a calibration signal, which is transferred to an external ECG recorder, if connected.

See section 3.2 for further information on ECG and ECG Marker calibration.

83Programming Guide

3.15 How to end a programming session

This section describes how to end a patient follow-up.

> Press End Session.

An on-screen message warns you that ending the session will cancel any print job being processed and clear all interrogated data from the programmer memory.

> Confirm this action by pressing OK. > To continue with the current follow-up, press Cancel.

Programming Guide

3.15 How to end a programming session

In the Vitatron desktop, which is displayed after ending the session, you can start a new Vitatron patient follow-up or switch to a Medtronic application.

> Turn off the programmer with the ON/OFF switch (position O).

Note:

Applying the programming head to a Vitatron pacemaker listed in the introduction to this manual, without switching off the programmer or without pressing End Session to close the current patient follow-up, starts the automatic pacemaker recognition procedure for the next pacemaker. This does not apply to Legacy, Legacy II and Visa pacemakers.

85Programming Guide

3.16 How to switch between Vitatron and Medtronic applications

To switch between Vitatron and Medtronic applications, proceed as follows:

> When using a Vitatron application, end the follow-up by pressing the

End Session button.

> Press the Vitatron to Medtronic button to enter the Medtronic model

selection screen.

A similar button in Medtronic applications will bring you back to Vitatron software. If the programmer shows a Medtronic screen layout upon start-up, this means that the last follow-up was a Medtronic session. Press the Medtronic to Vitatron button to enter the Vitatron application. If the last follow-up was a Vitatron session, the programmer will show the Vitatron application after you turn it on.

Note:

To switch to a Medtronic application during programming or interrogation of a Vitatron pacemaker, move the programming head away from the body, press End Session first, press OK to confirm this action, and then press the Vitatron to Medtronic button.

86 Programming Guide

3.17 How to cancel/activate the programming head magnet

During a pacemaker follow-up, the magnet mode can be either ON or OFF. The current magnet mode is shown at the top of the screen. With magnet mode switched off, the magnet remains inactive throughout the follow-up except during programming or interrogation of the pacemaker. This allows you to leave the programming head over the implanted pacemaker without having to submit your patient to the magnet rate.

Magnet is OFF

If the programmer displays this text at the top of the screen, the magnet is inactive.

> To change the magnet mode to ON, press Activate Magnet at the

bottom of the screen.

The text on this button changes to 'Cancel Magnet' allowing you to switch the magnet off if necessary. The text 'Magnet is ON' at the top of the screen indicates the new setting of the magnet mode.

Note:

The magnet ON/OFF status is only updated after positioning the programmer head.

87Programming Guide

3.17 How to cancel/activate the programming head magnet

Magnet is ON

If the programmer displays this text at the top of the screen, the magnet is active.

> To change the magnet mode to OFF, press Cancel Magnet at the bottom

of the screen.

The text on this button changes to 'Activate Magnet' allowing you to switch the magnet back on if necessary, while the text 'Magnet is OFF' at the top of the screen indicates the new setting of the magnet mode.

Programming Guide

4. Programming reference

In this chapter you can find out whether a particular parameter or feature is applicable to the pacemaker model you wish to interrogate or program and, if it is, how you can access that parameter or feature on the programmer.

The information is presented in several sets of tables which display the availability of parameters and features, followed by notes with specific programming details of the applicable pacemaker models.

89Programming Guide

4.1 Programming the Clarity DDDR, Clarity SSIR, Diamond 3, Ruby 3, Topaz 3 and Jade 3

Section 4.1 contains tables which display the availability of parameters and features of the above mentioned pacemakers. The information presented in this section should be read as follows.

Clarity DDDR, Clarity SSIR, Diamond 3,

Ruby 3, Topaz 3 and Jade 3

Clarity SSIR - A

Clarity SSIR - V

Clarity DDDR

Diamond 3

Parameter, Feature or Counter How to access Notes

Atrial Amplitude

●● ● ● ● ● Parameters [Atrial Lead]

●● ● ● ● ● Tests > Pacing Threshold

●● ● ● ● ● Parameters > Temp Param...

Topaz 3 - Ventr.

Topaz 3 - Atrial

Ruby 3

Jade 3 - Ventr.

Jade 3 - Atrial

A B C D

The name of the parameter, feature or counter.

Indicates for which products the parameter, feature or counter

is applicable.

Indicates where to find the parameter, feature or counter.

e.g. Parameters [Atrial Lead]

= select the icon 'Parameters', then look into column 'Atrial Lead'.

e.g. Tests > Pacing Threshold

= select the icon 'Tests', then select 'Pacing Threshold'.

Refers to the notes in section 4.3 that follow the tables and which deal with

specific programming details.

See the following reference tables for product-related programming details.

Programming Guide

4.1 Programming the Clarity DDDR, Clarity SSIR, Diamond 3, Ruby 3, Topaz 3 and Jade 3

Jade 3 - Ventr.

Jade 3 - Atrial

Topaz 3 - Ventr.

Topaz 3 - Atrial

Ruby 3

Diamond 3

Clarity DDDR

Clarity SSIR Atrial

Clarity SSIR Ventr.

●●●●● ● Tests > Pacing Threshold

●●●●● ● Parameters > Temp Param...

●●● Tests > VA & QT Interval

●●●●● ● Data > Status

●●●●● ● Tests > Pacing Threshold

Clarity DDDR, Clarity SSIR, Diamond 3, Ruby 3, Topaz 3 and Jade 3

Parameter, Feature or Counter How to access notes

Atrial Amplitude ●●●●● ● Parameters [Atrial Lead] 4

Atrial Amplitude Threshold ●●●●● ● Tests > Pacing Threshold 5

Atrial Blanking ●●● Parameters [Timing] 6

Atrial Burst Rate ●●● Tests > AOO Burst 3

Atrial Energy ●●●●● ● Data > Battery & Lead Meas. 7

Atrial Lead (Impl. date) ●●●●● ● Patient [System]

Atrial Lead Impedance ●●●●● ● Data > Battery & Lead Meas. 8

Atrial Measured Amplitude ●●●●● ● Data > Battery & Lead Meas. 9

Atrial Output Current ●●●●● ● Data > Battery & Lead Meas. 10

Atrial Pace Polarity ●●●●● ● Parameters [Atrial Lead] 11

91Programming Guide

4.1 Programming the Clarity DDDR, Clarity SSIR, Diamond 3, Ruby 3, Topaz 3 and Jade 3

notes

Jade 3 - Ventr.

Jade 3 - Atrial

Topaz 3 - Ventr.

Topaz 3 - Atrial

Ruby 3

Diamond 3

Clarity DDDR

Clarity SSIR Atrial

Clarity SSIR Ventr.

●●●●● ● Tests > Pacing Threshold

●●●●● ● Parameters > Temp Param...

●●●●● ● Tests > Sensing Test

●● ●● ●●● ● Parameters > Temp Param...

Parameter, Feature or Counter How to access

Atrial Pulse Duration ●●●●● ● Parameters [Atrial Lead] 12

Atrial Pulse Duration Threshold ●●●●● ● Tests > Pacing Threshold 13

Atrial Rate < .... Path (counter) ●●● Data > Counters

Atrial Rate > .... Path (counter) ●●● Data > Counters

Atrial Rate > .... Phys (counter) ●●● Data > Counters

Atrial Sense Polarity ●●●●● ● Parameters [Atrial Lead] 14

Atrial Sensitivity ●●●●● ● Parameters [Atrial Lead] 15

Atrial Sync. Pace ●● ● Parameters [Patient Safety] 16

Acceleration (Act only) ●● ●● ●●● Parameters [Mode/Rate Resp.] > Sensors 1

Programming Guide

ACT Threshold (Act only) ●●●●●●● Parameters [Mode/Rate Resp.] > Sensors

Adaptive AV Delay ●●● Parameters [Timing] 2

Angina ●● ●● ●●●●● Patient [Patient]

4.1 Programming the Clarity DDDR, Clarity SSIR, Diamond 3, Ruby 3, Topaz 3 and Jade 3

Jade 3 - Ventr.

Jade 3 - Atrial

Topaz 3 - Ventr.

Topaz 3 - Atrial

Ruby 3

Diamond 3

Clarity DDDR

Clarity SSIR Atrial

Clarity SSIR Ventr.

●● ●● ●●●●● Data > Status

Parameter, Feature or Counter How to access notes

AOO Burst ●●● Tests > AOO Burst 3

AV Hysteresis ●●● Parameters [Timing] 17

AV Synchrony (% Counter) ●● ● Data > Counters

Battery (Status) ●● ●● ●●●●● Data > Battery & Lead Measurement

Battery Impedance when depleted ●● ●● ●●●●● Data > Battery & Lead Measurement

Birth date ●● ●● ●●●●● Patient [Patient]

Burst Mode ●● ● Tests > AOO Burst 3

Change Chamber ●● ●●●● Parameters [Chamber] 18

Conditional hysteresis ●● ●● Parameters [Rate] 19

Deceleration ●● ●● ●●● Parameters [Mode/Rate Resp.] > Sensors 20

Detection beats ● Parameters [Mode/Rate Resp.] > SR Drop

Detection OFF rate ● Parameters [Mode/Rate Resp.] > SR Drop

Detection hysteresis ● Parameters [Mode/Rate Resp.] > SR Drop

Diagnostic observations ●● ●● ●●●●● Data [Status > Diagnostic observations]

ECG Markers ●● ●● ●●●●● Tests > ECG Markers

93Programming Guide

4.1 Programming the Clarity DDDR, Clarity SSIR, Diamond 3, Ruby 3, Topaz 3 and Jade 3

Jade 3 - Ventr.

Jade 3 - Atrial

Topaz 3 - Ventr.

Topaz 3 - Atrial

Ruby 3

Diamond 3

Clarity DDDR

Clarity SSIR Atrial

Clarity SSIR Ventr.

●● ●● ●●●●● Parameters >Rate [Night Rate Drop)

●● ●● ●●●●● Tests > Fast Learn

●● ●● ●●●●● Parameters [Rate]

●● ●● ●●●●● Data > Set Diagnostics

●● ●● ●●●●● Parameters > Temp Param...

Parameter, Feature or Counter How to access notes

End Night

Fast Learn

Flywheel

Histogram (set)

Histogram (Read, view & print) ●● ●● ●●●●● Data > ...Histogram 23

Holter (set) ●●●● ●●●●● Data > Set Diagnostics 43

Holter (Read, view & print) ●● ●● ●●●●● Data > ...Holter 24

Hysteresis ●● ● ● Parameters >Rate 25

Implant (PM implant. date) ●● ●● ●●●●● Patient [Patient]

Indication ●● ●● ●●●●● Patient [Patient]

Intervention deceleration ● Parameters [Mode/Rate Resp.] > SR Drop

Intervention rate ● Parameters [Mode/Rate Resp.] > SR Drop

Lower Rate ●● ●● ●●●●● Parameters [Rate] 26

Programming Guide

Max. AV delay ●●● Parameters [Timing] 27

Max. Sensor Rate ●● Parameters [Rate] 28

4.1 Programming the Clarity DDDR, Clarity SSIR, Diamond 3, Ruby 3, Topaz 3 and Jade 3

Jade 3 - Ventr.

Jade 3 - Atrial

Topaz 3 - Ventr.

Topaz 3 - Atrial

Ruby 3

Diamond 3

Clarity DDDR

Clarity SSIR Atrial

Clarity SSIR Ventr.

●●● ● Tests > VA & QT Interval

●●● Tests > VA & QT Interval

●● ●● ●●●●● Patient [System]

Parameter, Feature or Counter How to access notes

Max. Tracking Rate ●● Parameters [Rate] 29

Mode ●●●●●●●●● Parameters [Mode/Rate Response] 30

Mode Switching ● Data > Set diagnostics 31

Mode Switching Trend (set) ●●● Parameters [Mode/Rate Response] 31

Mode Switching Trend ● Data > Mode Switching Trend

Mode Switching Sensitivity ● Parameters [Mode/Rate Response] 32

Night Rate Drop ●●●● ●●●●● Parameters [Rate] 33

Onset ●●●●● Parameters [Mode/Rate Resp.] > Sensors 34

P Wave Amplitude ●●●●● ● Tests > Sensing Test 35

P Wave Histogram ●● ● Data > P Wave Histogram

Pacemaker Time ●●●● ●●●●● Parameters [Rate] > Night Rate Drop 33

Path Atrial Rate (% counter) ●● ● Data > Counters

Patient code ●●●● ●●●●● Patient [Patient]

Perc. Atrium Paced ●●●●● ● Data > Counters

95Programming Guide

4.1 Programming the Clarity DDDR, Clarity SSIR, Diamond 3, Ruby 3, Topaz 3 and Jade 3

Jade 3 - Ventr.

Jade 3 - Atrial

Topaz 3 - Ventr.

Topaz 3 - Atrial

Ruby 3

Diamond 3

Clarity DDDR

Clarity SSIR Atrial

Clarity SSIR Ventr.

●●Tests > QT Interval

Parameter, Feature or Counter How to access notes

Perc. T-Waves Sensed ●●●●●● Data > Counters

Perc. Ventricle Paced ●●●●●● Data > Counters

Pacemaker syndrome ●●●● ●●●●● Patient

PVC -> A Stim ●●● Parameters [Patient Safety] 36

PVC events ●●● Data > Counters

PVC events/time ●●● Data > Counters

PVCs (%) ●●● Data > Counters

QT Interval ●●● Tests > VA & QT Interval 37

QT provoking ●● Parameters [Mode/Rate Resp.] > Sensors 38

Rate response ●● Parameters [Mode/Rate Resp.]

Recovery search ● Parameters [Mode/Rate Resp.] > SR Drop 39

R-Wave Amplitude ●●●●●● Tests > Sensing Test 40

Refractory period ●● ●● ●●●●● Parameters [Timing] 41

Resynchronised by ASP (% counter) ●●● Data > Counters

Programming Guide

Retr. Cond. Episodes (counter) ●●● Data > Counters

Retr. Cond. Events (counter) ●●● Data > Counters

4.1 Programming the Clarity DDDR, Clarity SSIR, Diamond 3, Ruby 3, Topaz 3 and Jade 3

Jade 3 - Ventr.

Jade 3 - Atrial

Topaz 3 - Ventr.

Topaz 3 - Atrial

Ruby 3

Diamond 3

Clarity DDDR

Clarity SSIR Atrial

Clarity SSIR Ventr.

●● ● Data > Status

●● ●● ●●● Parameters [Mode/Rate Response]

●● ●● ●●●●● Data > Set Diagnostics

●● ●● ●●●●● Parameters > Nominals

●● ●● ●●● Parameters [Mode/Rate Resp.>Sensors]

●● ●● ●●●●● Parameters > Nominals

●● ●● ●●●●● Parameters [Rate] > Night Rate Drop

●● ●● ●●●●● Data > Status

Parameters [Mode/Rate Resp.]> SR Drop]

●●●●● Parameters [Mode/Rate Resp.] > Sensors

Tests > VA & QT Interval

●●●

●●●●● Tests > Sensing Test

●●Tests > QT Interval

Parameter, Feature or Counter How to access notes

Retr. Conduction (% counter) ●●● Data > Counters

Save to diskette ●●●●●●●●● Reports > Save

Selected event recording (set) ●● ● Data > Set Diagnostics

Selected event recording

Sensors

Set Histogram

Set Holter

Setting at Start of Session

Slope

Standard Setting

Start Night

Status

Sudden rate drop intervention ●

T Wave Sensitivity

97Programming Guide

4.1 Programming the Clarity DDDR, Clarity SSIR, Diamond 3, Ruby 3, Topaz 3 and Jade 3

Jade 3 - Ventr.

Jade 3 - Atrial

Topaz 3 - Ventr.

Topaz 3 - Atrial

Ruby 3

Diamond 3

Clarity DDDR

Clarity SSIR Atrial

Clarity SSIR Ventr.

● Tests > VA & QT Interval

●●●●●● Tests > Pacing Threshold

●●●●●● Parameters > Temp Param..

Parameter, Feature or Counter How to access notes

T-Wave Amplitude ●●●● ● Tests > Sensing Test 49

Tachy Fallback Rate ●● Parameters [Rate] 50

Temporary inhibit (OOO mode) ●● ●● ●●●●● Parameters > Temp Param.. 51

Time since last follow up ●●●●●●●●● Data > Counters

Time since last session ●●●●●●●●● Data > Status

Upper Rate ●● ●●●●● Parameters [Rate] 52

Upper Rate Approach ●●●● ● Parameters [Mode/Rate Resp.] > Sensors 53

Ventricular Amplitude ●●●● ●● Parameters [Ventricular Lead] 55

Ventricular Amplitude Threshold ●●●●●● Tests > Pacing Threshold 56

Ventricular Back Up Rate ●●● Tests > AOO Burst

Ventricular Blanking ●●● Parameters [Timing] 57

Programming Guide

Ventricular Energy ●●●●●● Data > Battery & Lead Meas. 58

Ventricular lead (implant. date) ●●●●●● Patient [System]

Medtronic 2090 Programming Guide

Specifications and Main Features

Frequently Asked Questions

User Manual

Table of contents

1. Introduction

2. The screen layout

3. Follow-up

4. Programming reference