Product information about the InSync III device and use of the
9790 series programmer is presented in two separate guides:
■
The InSync® III Model 8042 Device Programming Guide provides
instructions on how to use the programmer and the 9981
software with the InSync III device model.
■
The InSync® III Model 8042 Device Reference Guide is a
supplementary guide that provides detailed information
about the InSync III device model.
Note: A small technical manual, which contains information
about implantation, is also supplied with each InSync III device.
About this Guide
How to Use This Guide
This programming guide provides the following information.
■
How to setup and configure the programmer and access
on-line help.
■
How to start a patient session, use the various follow-up
features during the session, and properly end the session.
■
How to view and print the patient’s ECG and EGM waveform
traces.
■
How to configure the device to collect diagnostic data and
how to retrieve and view this information.
■
How to measure stimulation thresholds and sensing levels.
■
How to program parameter values and verify rate response
parameters settings.
InSync® III Model 8042 Device Programming Guideiii
How to Use This Guide
About the Device Reference Guide
The reference guide provides the following information, which
includes operation of the various InSync III device functions.
■
The pacing modes, rate response options, special therapy
features, telemetry types, and data collection options. In some
cases, guidelines are given on how to configure device
operation.
■
Parameter and data collection capabilities, longevity
projections, and mechanical and electrical specifications.
■
Troubleshooting information for electrical and hemodynamic
problems.
■
General warning and cautions and potential interference
sources.
ivInSync® III Model 8042 Device Programming Guide
Table of Contents
1. Programmer Basics
Tab l e o f Co n te nt s
How to Use This Guideiii
Information is Contained in Two Guidesiii
About this Guideiii
About the Device Reference Guide iv
Setting Up the 9790 Programmer 1-2
Programmer Setup Check List 1-2
Connecting an External Monitor/Recorder1-4
Connecting the Programmer to Skin Electrodes 1-6
Positioning and Using the Programming Head 1-7
When to Position the Programming Head1-7
Effect of the Programming Head on Operation of the
Implanted Device1-9
Observing Magnet Mode Operation1-10
Alternative PROGRAM and INTERROGATE Buttons1-
10
Automatic Interrogation at the
Start of a Session1-11
About the Display Screen 1-12
Features and Conventions of the Display Screen 1-12
Using the On-Screen Keyboard 1-17
Audible Tones 1-19
Programming Emergency Parameters1-20
Recording an ECG Strip1-21
About the ECG Recording 1-22
Using the On-line Help Feature1-24
Entering the Help System1-25
Using the Links in Help1-26
Exiting the Help System1-27
Searching for Information in Help1-27
2. Conducting a Patient Session
Important Reminders About Software Features for the InSync
III Device 2-2
InSync® III Model 8042 Device Programming Guidev
Tab le o f Con te nt s
Features of the Programmer Software2-2
Automated Monitoring and Collection of Patient
Diagnostic Data2-3
Starting a Patient Session2-4
The Starting Point of a Patient Session 2-4
The Tool Palette Between Sessions 2-5
About Automatic Interrogation2-6
Initial Interrogation Report2-7
Procedure for Starting a Patient Session2-7
Proceeding with Session Tasks 2-10
The First Task Screen 2-10
Selecting Another Task or Function 2-10
Consider Using Checklist2-10
Verifying or Changing Session Preferences 2-12
Interrogating the Implanted Device 2-15
Taking a Quick Look at Device Operation2-16
The Quick Look Screen 2-16
Viewing Data on the Quick Look Screen2-17
Viewing Battery and Lead Measurements2-20
Battery and Lead Measurements Screen2-20
Device Battery and Lead Measurements 2-21
Updating the Displayed Data2-22
Checking the Present Parameter Settings 2-23
The Therapy Parameters Screen2-23
Viewing Patient Information Stored in the Device 2-24
Recording an ECG Strip of Magnet Operation2-25
The Magnet Test Setup Screen 2-25
Procedure for Conducting a Magnet Test 2-26
Collecting an ECG Strip 2-27
About the Collected ECG Strips2-27
Checking the Patient’s Underlying Rhythm 2-28
The Underlying Rhythm Test Screen2-28
Procedure for Checking the Patient’s Underlying
Rhythm2-29
Collected ECG Strips 2-30
Printing Reports2-31
Using the Print Button2-31
viInSync® III Model 8042 Device Programming Guide
Tab l e o f Co n te nt s
Printing From the Available Reports Window 2-32
Printing Reports Held in the Print Queue2-33
Ending a Patient Session 2-34
Saving a Session on Diskette 2-35
Options for Clearing Device Data 2-37
3. Streamlining Follow-up with Checklist
About the Checklist Feature3-2
Using Checklist3-3
Creating a Custom Checklist 3-4
Selecting the Create/Edit Window3-4
Choosing a Source for Copying 3-5
Building the Custom Checklist3-6
Saving the Custom Checklist 3-7
4. Viewing the Patient’s ECG and EGM Traces
Viewing the ECG and Other Rhythm Waveforms4-2
Expanding the Live Rhythm Monitor Window 4-3
About the Waveform Traces4-4
Adjusting and Configuring the Display4-7
Adjusting Waveform Size 4-9
Selecting a Trace Source 4-9
Color Coding the Waveform Traces4-11
Selecting a Different Sweep Speed4-11
Programming a Different Telemetry Mode 4-12
Selecting the ECG Filter4-13
Enabling Artifact Enhancement4-14
Arranging the Waveforms4-14
Freezing and Analyzing a Waveform Strip 4-16
Using the On-Screen Calipers 4-17
Adjusting the Frozen Traces 4-18
Saving a Frozen Waveform Strip 4-19
Printing the Frozen Strip4-19
Recalling and Viewing Waveform Strips4-20
5. Collecting Diagnostic Data
Automatic Diagnostic Data Collection 5-2
Types of Data Displays5-2
InSync® III Model 8042 Device Programming Guidevii
Tab le o f Con te nt s
Important Points About Using Diagnostic
Data Collection5-3
Viewing the Collected Data 5-6
Viewing Procedure 5-6
Viewing Tools 5-8
About the Diagnostic Data Displays5-9
Heart Rate Histogram5-9
AV Conduction Histogram5-12
High Rate Episodes5-13
Ventricular Rate Histogram During Atrial High Rate 5-18
Ventricular Sensing Episodes 5-20
Chronic Lead Trends 5-22
Atrial High Rate Trend5-23
Night Heart Rate Trend5-24
Heart Rate Variability (HRV) Trend 5-26
Patient Activity Trend5-28
Programming Data Collection Options 5-30
Programming Procedure 5-30
Setting Up Histograms5-31
Setting Up High Rate Episodes5-31
Setting Up Ventricular Sensing Episodes 5-35
Clearing Data From the Device5-36
About the Clear Data Window5-36
6. Evaluating Parameter Settings
Measuring Stimulation Thresholds6-2
The Threshold Test Setup Screen 6-2
Setting Up a Threshold Measurement Test 6-3
Executing a Strength-Duration Threshold Test 6-6
Executing an Auto Decrement (Amplitude or Pulse Width)
Threshold Test6-13
Conducting a Manual Threshold Test 6-15
Determining a Sensitivity Setting6-18
The Sensing Test Setup Screen 6-18
Checking the Patient’s Intrinsic Rate 6-19
Executing an Automatic Sensing Test 6-19
Automatic Sensing Test Results 6-22
viiiInSync® III Model 8042 Device Programming Guide
Tab l e o f Co n te nt s
Executing a Manual Sensing Test6-23
Using Temporary Programming to Evaluate
Parameter Settings6-26
The Te mpo r ary Te st Se tup S c reen6-2 6
Procedure for Conducting a
Temp o rar y Test6-2 7
Programming a High Temporary Pacing Rate 6-29
7. Programming Device Parameters
Programming Parameters 7-2
Selecting the Therapy Parameters Screen 7-2
Programming, Printing, and Clearing Parameter
Va lu es7- 3
Parameter Restrictions7-4
How to Program Parameters 7-6
How to Program Subordinate Parameters 7-8
Resetting an ERI or Electrical Reset7-11
Saving/Retrieving a Set of Parameter Values7-14
Saving a Set of Parameter Values7-15
Retrieving a Saved or Nominal Set of Parameter Values7-
16
8. Rate Response Setup
Using Exercise Test to Verify Rate Response 8-2
Overview of the Exercise Test 8-2
Selecting the Exercise Test 8-3
Starting the Exercise Test8-3
Evaluating the Results of the Exercise Test8-5
Adjusting Rate Response8-6
9. Using the EP Studies Function
About the EP Studies Function9-2
Intended Use 9-2
General Warning 9-2
Precautions and Considerations 9-2
Protocol Options9-5
Using Ventricular (VOO) Backup Pacing9-7
Starting the EP Studies Function9-8
InSync® III Model 8042 Device Programming Guideix
Tab le o f Con te nt s
Pacing Mode Restrictions 9-8
Device Operating-Status Restrictions 9-8
Positioning the Programming Head9-8
Start-up Procedure 9-9
Before You Proceed 9-11
Setting Up and Executing a PES Protocol 9-13
Setting Up a PES Protocol 9-13
Executing the PES Protocol9-16
Setting Up and Executing a Burst Protocol 9-17
Setting Up a Burst Protocol 9-17
Executing the Burst Protocol9-19
Setting Up and Executing a VOO Burst9-20
PES Parameter Definitions and Values9-22
PES Parameter Definitions 9-22
PES Parameter Values 9-24
Burst Parameter Definitions and Values 9-25
Burst Parameter Definitions 9-25
Burst Parameter Values9-26
10. Miscellaneous Setup Options - Programmer and Device
Selecting System Operating Preferences10-2
Adjusting Programmer Time and Date10-4
Improving the Detection of Pacing Artifacts10-5
Checking the Software Version 10-6
Starting the Demonstrations Option 10-7
Programming Patient Data into Device Memory10-8
Connecting an External Printer 10-10
Printer Compatibility10-10
Materials You Will Need 10-12
Connecting the Printer10-13
A. Appendix: Parameter Values and Restrictions
Programmable Modes and ParametersA-2
Automatic Diagnostic Setup ParametersA-8
Programming RestrictionsA-10
I. Index
xInSync® III Model 8042 Device Programming Guide
Programmer Basics
This chapter provides an overview of setting up the
programmer and covers information you should be
familiar with before you begin a patient session.
This information includes such things as using the
programming head and stylus, programming
Emergency parameters, and recording an ECG strip.
Sections include an introduction to features of the
display screen and use of the on-line Help system.
1
1
Setting Up the 9790
Programmer 1-2
For more detailed information on setting up your
programmer, refer to Programmer Description and Setup,
a guide supplied with your 9790 series programmer.
InSync® III Model 8042 Device Programming Guide1-1
Connecting the Programmer to
Skin Electrodes1-6
Positioning and Using the
Programming Head 1-7
About the Display Screen 1-12
Programming Emergency
Parameters1-20
Recording an ECG Strip 1-21
Using the On-line Help
Feature1-24
Programmer Basics
Setting Up the 9790 Programmer
Setting Up the 9790 Programmer
The following topics summarize the basic steps for setting up
your 9790 series programmer. For more complete information on
setting up your programmer, refer to the guide, Programmer Description and Setup, supplied with your programmer.
Programmer Setup Check List
Verify that the components illustrated below are properly
connected to the programmer.
Selector Pen
(Stylus)
disconnect the stylus.
1-2InSync® III Model 8042 Device Programming Guide
Note: Do not
ECG Cable
Programming Head
Figure 1-1. The Programmer
Setting Up the 9790 Programmer
Figure 1-2. Power Cord
Programmer Basics
Figure 1-3. Programming Head
Figure 1-4. ECG Cable
InSync® III Model 8042 Device Programming Guide1-3
Programmer Basics
Setting Up the 9790 Programmer
Connecting an External Monitor/Recorder
To connect an external monitor or recorder to your programmer,
you need the optional adaptor shown below. Connect the adaptor
to the analog output port on the right side of the programmer.
w
Warning: Peripheral equipment connected to the 9790
programmer must be certified according to the applicable IEC
standards (IEC 950 for data processing equipment and IEC 601-1
for medical equipment). The system formed by connecting
peripheral equipment to the 9790 programmer must comply with
IEC 601-1-1 for medical electrical systems. It is the responsibility
of the person who connects the peripheral equipment to comply
with IEC standards. It is the responsibility of the user to keep
peripheral equipment that is certified to IEC 950 at least two
meters away from the patient. Contact the peripheral equipment
manufacturer for information about IEC certification.
Calibrate Button
Connecting Optional Adaptor to the Analog
Output Port on the Programmer.
Connector Type: BNC
Output Signal: ± 1Volt or ± 5 mV (switchable)
Signal Output Adaptor
A
± 1V± 5mV
Adaptor Output Signals
(after model selection):
A - Patient’s ECG
B - Telemetered EGM
C - Telemetered EGM
D - Marker Channel Telemetry
BCD
Figure 1-5. Connecting the Optional External Adaptor
1-4InSync® III Model 8042 Device Programming Guide
Programmer Basics
Setting Up the 9790 Programmer
Using the Calibrate Button
Selecting the Calibrate button located next to the analog output
port adds a reference signal (as shown in Figure 1-6 and
Figure 1-7) to the trace of Marker Channel and EGM telemetry.
The Marker Channel signal shows the relative marker amplitudes,
which are not annotated with character codes on an external
device. The EGM calibration signal acts as a voltage reference for
the displayed EGM.
Atrial Pace (AP)
Atrial Sense (AS)
Atrial Refractory Sense (AR)
Vent. Refractory Sense (VR)
Vent. Sense (VS)
or Biventricular Pace (BV)
Vent. Pace (VP)
Figure 1-6. Marker Channel Signals
5 mV
1 mV
Figure 1-7. EGM Calibration Signals
InSync® III Model 8042 Device Programming Guide1-5
Programmer Basics
Connecting the Programmer to Skin Electrodes
Connecting the Programmer to Skin Electrodes
At the start of a patient session, the programmer must be
connected to skin electrodes on the patient. The ECG display and
measurement functions will not operate without detection of the
surface ECG signal.
Use an electrode lead to connect each skin electrode to the
appropriate port on the ECG cable. Typical electrode placement is
shown below. Use standard procedures for attaching disposable
skin electrodes to the patient.
RA (R)
RL (N)
Figure 1-8. Connecting the Programmer to Skin Electrodes
Refer to the guide, Programmer Description and Setup, supplied
with your 9790 programmer for more details on this procedure.
LA (L)
C (C)
LL (F)
( ) = IEC Coding
1-6InSync® III Model 8042 Device Programming Guide
Programmer Basics
Positioning and Using the Programming Head
Positioning and Using the Programming Head
In many of the procedures described in the following chapters,
you will be directed to position the programming head over the
patient’s implanted device.
When to Position the Programming Head
You must position the programming head over the patient’s
implanted device whenever a procedure initiates communication
between the programmer and the implanted device. Examples
are:
■
At the start of a patient session when you select the
[
Auto-Identify]or[Start]button. The programmer
automatically initiates an interrogation that takes a number of
seconds to complete.
■
Prior to executing any command that results in a telemetry or
programming transmission.
■
To view or record Marker Channel or EGM telemetry.
Caution: Do not position the programming head over an
implanted device during electrocautery or defibrillation
procedures.
InSync® III Model 8042 Device Programming Guide1-7
Programmer Basics
Positioning and Using the Programming Head
How to Position the Programming Head
♦
The programming head must be properly positioned as described
below. An incorrectly positioned programming head can result in
the failure of a transmitted command and the loss of telemetry.
1. Hold the programming head directly against the patient’s
skin with the face of the programming head parallel to the
implanted device.
Figure 1-9. Positioning the Programming Head
2. Position the programming head so that the amber light in
the light array goes out and one or more of the green lights
come on. Move the head a little in each direction to find the
position that lights the greatest number of green lights. This
is the optimum position.
Light Array
Figure 1-10. Light Array Indicator
1-8InSync® III Model 8042 Device Programming Guide
Green
Amber/Green
Programmer Basics
Positioning and Using the Programming Head
Effect of the Programming Head on
Operation of the Implanted Device
If model selection and application (software) loading are
complete, positioning the programming head over an implanted
InSync III device does not put the device in the magnet mode of
operation, as is the case with previous device models. The
programmer automatically sends a Cancel Magnet command to
the implanted device, which causes it to continue to operate as
programmed.
An exception to this operation can occur if the programming head
does not establish a telemetry link with the implanted device
(because of strong electrical interference or because the
programming head is improperly positioned). In such cases,
positioning the programming head would result in magnet mode
operation until a telemetry link is established. You can easily
verify the present pacing mode by observing the Status Line at the
top of the screen.
The present pacing mode
shows in the status bar at
the top of the screen.
Operation of the implanted device returns to its programmed
state about 2 seconds after you remove the programming head
from its position over the device.
InSync® III Model 8042 Device Programming Guide1-9
Programmer Basics
Positioning and Using the Programming Head
Observing Magnet Mode Operation
To observe Magnet mode operation during a patient session, you
must conduct the Magnet test described in Chapter 2. Initiating
the Magnet test results in a Threshold Margin Test (TMT) and
causes the implanted device to operate in the Magnet mode.
Note: Between patient sessions before you select the device
model, positioning the programming head over the implanted
device will result in magnet mode operation.
Alternative PROGRAM and
INTERROGATE Buttons
To initiate the Program and Interrogate commands, you have the
option to use the on-screen [
the Program [
head.
Program] and[Interrogate] buttons or
P] and Interrogate [I] buttons on the programming
Light Array
[Interrogate] Button
Figure 1-11. Alternative Program and Interrogate
Programming Head Buttons
Note: The [P] or [I]button on the programming head is active only
when its counterpart is displayed as an active button on the
display screen.
1-10InSync® III Model 8042 Device Programming Guide
[Program] Button
Programmer Basics
Positioning and Using the Programming Head
Automatic Interrogation at the
Start of a Session
At the start of a session when you select [Start] or [Auto Identify],
the programmer automatically interrogates the patient’s
implanted device. For this process, you must position the
programming head and hold it steady in place until the
interrogation is complete.
At the bottom center of the screen, an indicator shows the progress
of the interrogation. Because this interrogation retrieves
parameter information and a portion of the diagnostic data stored
in the implanted device, the process may take about one minute.
InSync® III Model 8042 Device Programming Guide1-11
Programmer Basics
About the Display Screen
About the Display Screen
The programmer display screen is an interactive device that not
only displays information in the form of both text and graphics,
but functions as a control panel by displaying buttons and menu
options that you can select using the stylus.
Features and Conventions of the
Display Screen
This section describes the features and conventions of the display
screen. The Therapy Parameters screen below shows the main
elements of the typical screen.
Status Bar
Live Rhythm
Monitor Window
Task area
Command Bar
Active FieldButtonTool Palette
Figure 1-12. Main Elements of a Display Screen Example
1-12InSync® III Model 8042 Device Programming Guide
Status Bar
Programmer Basics
About the Display Screen
The Status Bar
The status bar at the top of the screen shows:
■
The present pacing mode.
■
When any one of a number of test conditions is occurring.
■
The device model.
The Live Rhythm Monitor Window
This window is a partial view of the full-screen display of ECG,
Marker Channel, and telemetered EGM waveform traces. You can
expand this window to its full size by selecting the small square
button in the upper-right corner of the window or by selecting the
[
Adjust...] button.
Live Rhythm
Monitor Window
■
Heart rate and rate interval show if the programming head is
positioned over the implanted device.
■
Annotations above the waveform trace show the point of
programmed parameter changes.
The wavefor m trace or t races t hat show i n this win dow depen d on
the selected task screen and how traces have been arranged in the
full-screen view. Refer to “Viewing the ECG and Other Rhythm
Waveforms” on page 4-2 for information about the live rhythm
monitor.
InSync® III Model 8042 Device Programming Guide1-13
Programmer Basics
About the Display Screen
The Command Bar
The bar at the bottom of the screen always shows the command
buttons for programming “emergency” parameters settings,
interrogating the implanted device, and ending the patient
session.
For complete information on these functions, see “Programming
Emergency Parameters” on page 1-20, “Interrogating the
Implanted Device” on page 2-15, and “Ending a Patient Session”
on page 2-34.
The Task Area
The portion of screen between the live rhythm monitor window at
the top and the command bar at the bottom changes according to
the task or function you select. The example in Figure 1-12 shows
the Therapy Parameters screen for programming device
parameter settings. This task area would appear much different if
you selected, for example, the Threshold Test Setup screen.
Active Fields
Unshaded areas, or boxes, appearing in the task area are “active
fields” that respond to the stylus.
Active fields show as
unshaded areas on
1-14InSync® III Model 8042 Device Programming Guide
the screen.
Selecting a value, word, name, or phrase that appears in an active
field opens a menu or window of alternative options for whatever
is represented in that field.
Selecting an active field
opens a menu or window
of alternative options, or
in some cases, an
on-screen keyboard.
Programmer Basics
About the Display Screen
For example, touching the mode value “DDD” in the Mode field
with the tip of the stylus opens a window of mode options.
Selecting any one of these options replaces the original DDD value
with the selected one, which becomes a “pending” value.
Selecting some fields (those with terms ending in an ellipsis, such
as “Rate Response...”) open a window displaying additional
fields. Some fields that require entry of information, such as
patient data, open an on-screen keyboard. How to use this
keyboard is described later in this section.
Buttons having a less
distinct shaded label
are not presently active.
Buttons
Buttons like those shown below let you operate the programmer
using the stylus. You can “press” a button by touching it with the
tip of the stylus.
Buttons may directly execute a command, such as the [
button, or they may open a window that prompts another action.
Usually such buttons have a label ending with an ellipsis, such as
the [
Save...] or [Get...] buttons shown above.
InSync® III Model 8042 Device Programming Guide1-15
Program]
Programmer Basics
About the Display Screen
Buttons
Icons
A procedure may instruct you to “press and hold” a button. In
such cases you should touch the tip of the stylus to the button and
continue to maintain pressure against the button until it is time to
“release” the button.
The Tool Palette
The collection of buttons and icons along the edge of the screen is
referred to as the “tool palette.” These are the controls you will use
to choose the task or function screen you want displayed. Once
you have started a patient session, the tool palette is always
displayed, making it quick and easy to move to the desired task or
function.
Each of the icons acts like a button. To select an icon, touch the icon
with the stylus. The “<” symbol adjacent to three of the icons
indicates that selecting one of these icons opens a menu of related
options. The icons without the < symbol directly open a task
screen.
Refer to Table 2-2 on page 2-11 for a brief explanation of the
purpose of each button and icon in the tool palette.
Note: If the programmer is operating in the Demo mode, the
Session icon is replaced with the Demo icon.
1-16InSync® III Model 8042 Device Programming Guide
Programmer Basics
About the Display Screen
Using the On-Screen Keyboard
Certain fields on the screen allow you to enter data, such as the
patient’s name or chart number. Selecting such a field
automatically displays the on-screen keyboard shown below. By
touching the letter or character buttons with the stylus, you can
use this display feature like an actual keyboard.
Text Entry Window
Space Bar
Figure 1-13. Keyboard Screen
Cursor
Position Keys
The function of the on-screen keyboard buttons are very similar to
the keys on a computer keyboard or typewriter (see “Keyboard
Buttons” on page 1-18).
InSync® III Model 8042 Device Programming Guide1-17
Programmer Basics
About the Display Screen
Tab le 1-1. Keyboard Buttons
Button or FeatureFunction
Text Entry Window
(See Figure 1-13)
Shows the text as you enter it using the
keyboard. You can enter only as many
characters as can fit in the selected field.
Clears all characters from the text entry
window.
Closes the Keyboard screen without changing
the selected field.
Deletes the character to the left of the cursor in
the text entry window.
Not intended for use.
Locks all characters into upper case until the
[Caps] key is selected again. While the [Caps]
key is down, the [Shift] and [Shift Lock] keys
operate as described below except that
characters will shift to lower case.
Shifts all of the characters into upper case and
replaces the top row of numbers with
commonly used symbols. This shift cancels
automatically after you select a character or
symbol.
Locks all of the characters into upper case and
replaces the top row of numbers with
commonly used symbols. Press this key again
to return to number keys and lower case.
Shifts the keyboard to a limited set of
characters. Selecting a character or symbol
cancels [Alt] key.
Space Bar
(See Figure 1-13)
Inserts a blank space.
Moves the cursor one space to the left or the
right.
Closes the Keyboard screen and enters the text
in the text entry window into the selected field.
1-18InSync® III Model 8042 Device Programming Guide
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