Medtronic 8040 Programming Guide
®
/C/TEMP/198676001C_view.pdf
INSYNC
Device Model 8040
Programmer Software Model 9980
Device Programming Guide
Caution: Federal law (USA) restricts this device to sale by or on
the order of a physician.
InSync® Model 8040 Device
Programming Guide
A Guide to using the
9790 series programmer
and 9980 software with
the InSync device
4
The following terms are trademarks of Medtronic.
InSync, marker Channel, and Medtronic
5
About This Programming Guide
Information about the InSync Model 8040 device is presented in
two separate guides: the InSync Model 8040 Device Programming
Guide (this guide) and the InSync Model 8040 Device Reference
Guide.
This programming guide provides instructions for using a 9790
series programmer with the InSync Model 8040 device. Sections
describe the applicable programming and follow-up functions
and present step-by-step procedures for using these functions.
Information is organized into the 9 chapters and one appendix:
Chapter 1 – Introductory information
Chapter 2 – General procedures
Chapter 3 – Starting and ending a patient session
Chapter 4 – Retrieving system data
Chapter 5 – Displaying and printing the patient’s ECG and EGM
Chapter 6 – Programming the device parameters
Chapter 7 – Determining and evaluating parameter settings
Chapter 8 – Using the diagnostic data recording function
Chapter 9 – Programmer setup options, such as setting the time
and date
Appendix A – Programmable parameters, values, and
programming restrictions
The InSync Model 8040 Device Reference Guide provides
information about the functions and operation of the device. The
reference guide is supplemental to the Product Information
Manual packaged with the InSync device.
InSync® Model 8040 Device Programming Guide iii
6
iv InSync® Model 8040 Device Programming Guide
7
Table of Contents
About This Programming Guide iii
1. Using the Programmer with an InSync Device
When to Use this Manual 1-2
Conventions Used in this Manual 1-3
General Warnings and Precautions 1-4
Display Screen Format and Interactive Features 1-7
A Guide to Using the Menu and Command Buttons 1-11
2. Procedures to Know Before You Begin
Using the Programming Head 2-2
Programming Emergency Parameters 2-5
Interrogating the InSync Device 2-6
Canceling Effects of the Programming Head Magnet 2-8
Printing Reports During a Patient Session 2-9
Automatic Printing with the Printer Trace Mode 2-12
Printing Reports After a Session Has Ended 2-13
Transferring Session Data to a Diskette 2-14
Using the HELP Options 2-17
3. Starting and Ending a Patient Session
Before You Begin 3-2
Turning the Programmer ON 3-3
Starting a Patient Session 3-4
Selecting the Desired Function 3-6
Ending a Patient Session 3-8
4. Retrieving System Data
Displaying Present Parameter Settings 4-2
Displaying a Status Summary 4-6
Displaying Battery and Lead Information 4-11
Displaying a Graph of Recorded Diagnostic Data 4-14
5. Displaying and Printing the Patient’s ECG and EGM
Printing the Patient’s ECG and EGM 5-2
Displaying the Patient’s ECG and EGM 5-5
InSync® Model 8040 Device Programming Guide v
8
Freezing the ECG Trace 5-11
Displaying a Marker Channel Diagram 5-15
6. Programming the Pacing Parameters
Programming Pacing Parameters 6-2
Programming Additional Parameters 6-12
7. Determining and Evaluating Parameter Settings
Measuring Stimulation Thresholds 7-2
Determining a Setting for Sensitivity 7-21
Determining Rate Response Parameter Settings 7-28
Programming Temporary Parameter Values 7-38
Measuring Rate and AV Interval 7-41
8. Collecting and Retrieving Diagnostic Data
About the Diagnostics Function 8-2
Types of Data You Can Record 8-4
Recording Data From a Non-Paced Chamber 8-17
Programmable Parameter Options 8-19
About the Setup Options 8-22
Programming the Device to Record Data 8-24
Displaying a Graph of the Recorded Data 8-29
Printing the Diagnostic Data 8-32
Clearing Recorded Data From the Device 8-33
9. Programmer Setup Options
Setting the Time and Date 9-2
Connecting an External Recorder or Monitor 9-4
Using the CALIBRATE Option 9-5
Improving the Detection of Pacing Artifacts 9-7
A. Appendix A - Parameter Values and Restrictions
Programmable Modes and Parameters A-2
Programming Requirements and Restrictions A-6
Temporary Modes and Parameters A-9
I. Index
vi InSync® Model 8040 Device Programming Guide
9
Using the Programmer
General Desciption
with an InSync Device 1
This chapter introduces you to using your 9790 series
programmer with the InSync device.
When to Use this Manual 1-2
Conventions Used in this
Manual 1-3
General Warnings and
Precautions 1-4
Display Screen Format and
Interactive Features 1-7
A Guide to Using the Menu and
Command Buttons 1-11
1
10
InSync® Model 8040 Device Programming Guide 1-1
When to Use this Manual
Installation of the 9980 software adds the InSync Model 8040
device to the programming and follow-up capabilities of your
9790 series programmer. Several manuals now cover the use of
your programmer, each covering a specific set of implantable
device models.
InSync Model 8040 device – If you select this device model, refer
to this manual for instructions on using the programmer.
Other device models – If you select a device model other than the
InSync Model 8040 device, refer to the appropriate programming
guide supplied with the software application for that device. The
front cover of each programming guide lists the device models
covered in that guide.
For detailed information on setting up the 9790 programmer, refer
to the instruction manual, Programmer Description and Setup,
supplied with the programmer.
1-2 InSync® Model 8040 Device Programming Guide
11
Conventions Used in this Manual
This manual uses the following text format conventions in the
instructions for using the programmer.
[INTERROGATE] Boldface small capitals within brackets denote
THRESHOLD TEST Boldface capitals without brackets denote a
1., 2., 3 Boldface numbers at the left column margin
➤ This symbol identifies a single instructional
■ This symbol is used as a bullet indicating
an on-screen button.
selectable screen option other than a button.
identify instructional steps.
statement.
itemized statements or paragraphs.
12
InSync® Model 8040 Device Programming Guide 1-3
General Warnings and Precautions
These warnings and precautions apply in general to using a 9790
series programmer.
Warnings
Using the Programmer
Programming should be done only after careful study of the
device technical manual and the applicable portions of this
manual and after careful determination of appropriate parameter
settings. Improper use of the programmer could result in
erroneous or inadvertent programming and improper operation
of the telemetry and measurement functions.
The 9790 series programmer must be used only for programming
Medtronic devices listed as applicable units for the software being
used. Direct stimulation via energy coupling may occur if the
programmer is used on other implanted devices. This
programmer is not compatible with programmable devices of
other manufacturers.
Implantable Defibrillator
Some patients may also require therapy from an implantable
defibrillator.
■
Only bipolar pacing should be used with these patients. In
some cases, pacing in the unipolar configuration may cause
the defibrillator to either deliver inappropriate therapy or to
withhold appropriate therapy.
■
Programming Lead Monitor with the optional polarity switch
is contraindicated for patients with an implanted defibrillator.
When an out-of-range lead is detected, the monitor
automatically reprograms selected leads to unipolar polarity.
Pacing in the unipolar configuration may either cause the
defibrillator to provoke inappropriate therapy or to withhold
appropriate therapy.
1-4 InSync® Model 8040 Device Programming Guide
13
■
Programming the Transtelephonic Monitor On is
contraindicated for patients with an implanted defibrillator.
When the monitor is programmed On, the pacing polarity is
temporarily set to unipolar when the magnet is applied over
the implanted device. Pacing in the unipolar configuration
may either cause the defibrillator to provoke inappropriate
therapy or to withhold appropriate therapy.
Precautions
High Rate Stimulation
Before and after the use of high-rate stimulation, the clinician
should interrogate the implanted device to determine the battery
status and elective replacement indicator (ERI) condition.
High-rate stimulation over several years, or with the battery
partially depleted, may trigger the ERI prematurely.
Loss of Programmer Power
If power to the programmer is unexpectedly lost, lifting the
programming head from over the patient’s device cancels any
temporary parameters or functions in effect and restores the
device to its permanently programmed state.
14
Unresponsive Screen
In the unlikely event the programmer display screen becomes
unresponsive or “locked,” turn the programmer off, wait
5 seconds, then turn the programmer on. Normal programmer
operation should resume. Following successful completion of the
self test, reselect the device model to continue with the
application.
Programming Head
Failure to correctly align the programming head over the InSync
device could result in failure of a programming transmission and
failure to receive telemetry. The programming head should not be
positioned over an implanted device during electrocautery or
InSync® Model 8040 Device Programming Guide 1-5
defibrillation procedures. Refer to “Using the Programming
Head” in Chapter 2 for specific information about using the
programming head.
1-6 InSync® Model 8040 Device Programming Guide
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Display Screen Format and Interactive Features
This section describes the appearance of the programmer display
screen and the scheme for selecting the various functions or tasks
you wish to accomplish during the patient session.
Display Screen Example
Below is an example of the screen format you will see when you
use the programmer with an InSync device.
Menu Buttons
Device ID
Screen Title
ECG Display
Function Display Area
16
Message Box
Command Buttons
Figure 1-1. Features of the Display Screen
The main elements of this screen format are as follows:
Menu Buttons – The menu buttons, which appear across the
top of each screen, provide direct access to the applicable
programmer functions.
Device ID – Displays the selected device family name and model
number.
InSync® Model 8040 Device Programming Guide 1-7
Screen Title – Title of the current screen generally appears in this
location.
ECG Display – This box continuously displays a low-resolution
trace of the patient’s ECG.
Function Display Area – This area of the screen changes
according to the selected function. It displays the data, buttons,
and options that apply to the selected function.
Message Box – The message box continuously displays
procedural prompts and status messages including warnings
and precautions, when appropriate. It is important to read the
information presented in the Message Box whenever you are operating
the programmer.
Command Buttons – Location of the [
MAGNET], [INTERROGATE], and [INTERROGATE ALL] buttons is
the same on all function screens where they apply. The
[
EMERGENCY] programming button appears in this location on all
function screens.
PROGRAM], [CANCEL
Interactive Screen Features
The display screen has interactive features that respond to
application of the touch pen, or stylus, are: 1) on-screen buttons
and 2) options that appear in boldface type. The following are
some examples of buttons and options.
Buttons appear as boldface words or symbols enclosed within a
black rectangular border. Buttons with labels ending in an ellipsis
(...) open a window of additional options.
Button Examples
1-8 InSync® Model 8040 Device Programming Guide
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Selectable options, which appear in boldface type, include device
model options, parameters, parameter values, and menu options.
Selectable options
appear in boldface
lettering.
Selecting a Button
➤ Without touching the screen, move the tip of the stylus to a
position directly over the button; then press the stylus
against the screen.
If the button is a “locking” button (one that remains selected), the
button label will change to reverse video to indicate that it is
selected.
If a procedure directs you to “press and hold” a button, you must
press the stylus against the button and continue to press for as
long as you want the related operation to continue.
18
Selecting an Option
➤ Without touching the screen, move the tip of the stylus to a
position directly over any part of the boldface option label
(may be a word or number); then press the stylus against the
screen.
InSync® Model 8040 Device Programming Guide 1-9
Audible Signals
Certain events in the operation of the programmer will result in an
audible signal of one or two tones, or “beeps.” These signals are
intended to alert the user to the success or failure of an action.
Single Beep = Success
■
A single beep following an Interrogate command indicates
that the interrogation was successful.
■
A single beep following a Program command indicates that
the programming was confirmed.
Two Beeps = Failure
■
Two beeps following an Interrogate command indicate that
the interrogation was not successful.
■
Two beeps following a Program command indicate that the
programming was not confirmed.
Two Low-Tone Beeps
Two low-tone beeps sound when the selected command cannot be
executed.
Single Short Beep
A short beep that coincides with pressing the
PROGRAM key on the programming head indicates that the
programmer acknowledges the keystroke. If the keystroke is
inappropriate, two low-tone beeps will sound.
1-10 InSync® Model 8040 Device Programming Guide
19
INTERROGATE or
A Guide to Using the Menu and
Command Buttons
Using the Menu Buttons
Except for [END SESSION] and [FREEZE], selecting a menu button
at the top of the screen displays a drop-down menu of related
function options. A check mark (✓) next to a displayed option (see
example below) indicates that option is currently selected.
Menu Buttons
Drop-down Menu
Note: To close the menu without making a selection, “click” the
stylus anywhere on the display screen outside the menu box.
Listed below is a description of the options accessible with each of
the menu buttons. Refer to the listed chapter for the procedure
associated with each option.
20
Retrieving Device System Data – See Chapter 4.
Selecting the [
■
Viewing a summary of interrogated data.
■
Viewing measured real-time values of battery and lead data.
■
Viewing a graph of accumulated diagnostic data.
DATA] menu button displays options for:
InSync® Model 8040 Device Programming Guide 1-11
Displaying the Patient’s ECG and EGM – See Chapter 5.
Selecting the [
TESTS/ECG] menu button displays an option for
viewing and adjusting the patient’s ECG and the EGM and
Marker Channel signals received from the implanted device via
telemetry. The ECG display includes an option for inhibiting the
output of the patient’s device.
Conducting Device System Tests – See Chapter 7.
Selecting the [
■
Measuring stimulation thresholds.
■
Determining a setting for device sensitivity.
■
Determining a setting for Activity Threshold and Rate
TESTS/ECG] menu button also displays options for:
Response.
■
Programming temporary parameter settings.
■
Measuring rate and AV interval.
■
Conducting electrophysiologic studies if 9886A or 9891A
software is installed. Instructions are covered in a supplement
supplied with the software.
Programming Parameter Settings – See Chapter 6.
Selecting the [
PARAMETERS] menu button displays options for:
■
Programming stimulating parameters and viewing present
settings.
■
Accessing additional parameter options including Extended
Telemetry, Transtelephonic Monitor, Serial Number, and
Status Reset.
Setting Up the Diagnostics Function – See Chapter 8.
Selecting the [
for programming the device to record the selected type of
diagnostic data.
Ending the Patient Session – See Chapter 3.
Selecting the [
session and return to the implantable device model selection
screen.
1-12 InSync® Model 8040 Device Programming Guide
21
PARAMETERS] menu button also displays an option
END SESSION] menu button lets you end the patient
Special Options – See Chapters 2 and 9.
Selecting the [
SPECIAL] menu button provides access to the
following options:
■
A Position Head Assist option related to using the
programming head (Chapter 2).
■
A Calibrate option that sends a Marker Channel or EGM
reference signal to an externally connected recorder or
monitor (Chapter 9).
Freezing the ECG Trace – See Chapter 5.
Selecting the [
FREEZE] menu button freezes a 10-second segment
of the patient’s ECG and provides the option for viewing a Marker
Channel diagram if the device is operating in a permanently
programmed triple chamber or VDD mode.
Printing Reports – See Chapter 2.
Selecting the [
PRINT] menu button displays options for printing
the various data reports generated during the patient session.
Viewing Help Information – See Chapter 2.
Selecting the [
HELP] menu button displays options for viewing
information about the currently displayed screen and other
subjects related to using the programmer.
22
Using the Command Buttons
Listed below is a description of each of the command buttons
located at the bottom of the display screen. Refer to the listed
chapter for the procedure associated with using a particular
command button.
InSync® Model 8040 Device Programming Guide 1-13
Programming Emergency Parameters – See Chapter 2.
Selecting the Emergency command overrides any function and
immediately programs the device to a fixed set of permanent
values that provide high output pacing in the VVI mode.
Canceling the Programming Head Magnet – See Chapter 2.
Selecting the Cancel Magnet command cancels the effect of the
programming head magnet and allows the device to operate in its
permanently programmed state while the programming head is
in position. For example, operation of a device permanently
programmed to the DDD mode will change from the DOO
magnet mode to the DDD mode when this command is executed.
Interrogating the Device – See Chapter 2.
Selecting the Interrogate command from a particular function
screen retrieves from the device the data related to that function.
Interrogating All Data – See Chapter 2.
The Interrogate All command retrieves all data (parameter,
battery/lead, and diagnostic) from the device. This button
appears only on the Pacing Parameters screen.
Returning to the Pacing Parameters Screen –
On screens other than the Pacing Parameters screen, this button
appears in place of [
INTERROGATE ALL]. Selecting this button
returns you directly to the Pacing Parameters screen.
Programming Command – (Covered in the procedures).
This command executes a temporary or permanent programming
transmission based on the procedure being conducted. This
button appears only when programming is allowed.
1-14 InSync® Model 8040 Device Programming Guide
23
Procedures to Know
General Desciption
Before You Begin 2
This chapter covers some procedures that you might
use at any point during a patient session. You should
be familiar with these procedures before you begin a
patient session.
Using the Programming
Head 2-2
Programming Emergency
Parameters 2-5
Interrogating the InSync
Device 2-6
Canceling Effects of the
Programming Head Magnet 2-8
Printing Reports During a Patient
Session 2-9
2
24
Automatic Printing with the
Printer Trace Mode 2-12
Printing Reports After a Session
Has Ended 2-13
Transferring Session Data to a
Diskette 2-14
Using the HELP Options 2-17
InSync® Model 8040 Device Programming Guide 2-1
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.
■
Always position the programming head prior to executing
any command that results in a programming or telemetry
interaction between the programmer and the device.
■
Improper positioning of the programming head could result
in the inability to program the device or to receive telemetry.
Positioning the Programming Head
Caution: Do not position the programming head over an
implanted device during electrocautery or defibrillation
procedures.
For an implanted device:
1. Position the programming head directly against the patient’s
skin with the face of the programming head parallel to the
device.
2. Position the programming head so that the amber light in the
light array on the head goes out and one or more green lights
come on.
3. Move the head to the position that lights the greatest number
of green lights. This is the optimum position.
2-2 InSync® Model 8040 Device Programming Guide
25
Light Array
Note: Device operation returns to its permanently programmed
settings about 2 seconds after you remove the programming head
from its position over the implanted device.
The programmer also has a programming head position indicator
light located near the upper left corner of the screen. This indicator
light goes out when a telemetry link with the device has been
established — or it may change from amber to green — see Using
the POSITION HEAD ASSIST Option below).
Using the POSITION HEAD ASSIST Option
The Position Head Assist function facilitates using the head
position light on the programmer to locate the optimum head
position over the patient’s device. This function is particularly
useful under conditions that adversely affect the communication
link between the programmer and device.
Assist enabled – The programming head position light on the
display panel changes from amber to green when the
programming head is properly positioned.
Assist disabled – The amber position light goes out when the
programming head is positioned.
26
The light array on the programming head operates the same with
or without the Assist function.
Note: When the Assist function is enabled (“Enhanced” option),
continuous interaction between the programmer and device can
cause extraneous artifacts to appear at 250 ms intervals on the
patient’s ECG trace. The programmer automatically filters these
artifacts so they do not appear. Although these artifacts can
obscure pacing artifacts or small details on the ECG trace, they
have no effect on the pacing operation of the device.
The default setting for the Assist function is Enhanced. That is, the
Assist function is already in effect when you start a patient
session. If this function results in extraneous artifacts on other
monitoring devices connected to the patient, you can turn the
Assist function off by selecting the “Normal” option (see next).
InSync® Model 8040 Device Programming Guide 2-3
Procedure for Selecting the Position Head Assist Setting
1. Select [SPECIAL] from the menu buttons at the top of the
screen.
2. Select
POSITION HEAD ASSIST from the options displayed.
3. From the window showing two buttons:
➤ Select [
➤ Or select [
ENHANCED] to enable the Assist function.
NORMAL] to disable the Assist function.
Using PROGRAM / INTERROGATE Keys
The PROGRAM and INTERROGATE keys on the programming head
have the same function as the [
buttons that appear on the display screen. Whenever the
instructions in this manual direct you to select the [
[
INTERROGATE] button on the screen, you can press the
corresponding key on the programming head instead, if it is more
convenient.
INTERROGATE Key
PROGRAM] and [INTERROGATE]
PROGRAM] or
PROGRAM Key
Figure 2-1. PROGRAM and INTERROGATE Keys on the
2-4 InSync® Model 8040 Device Programming Guide
27
Programming Head
Programming Emergency Parameters
The [
]
The Emergency programming command is a safety feature that
overrides all other functions and immediately programs the
device to preset emergency values intended to provide pacing
support under a variety of conditions. This programming cancels
any temporary function in effect and restores magnet mode
operation.
Emergency values are permanent settings that provide higherthan-normal energy output. It is not intended that the device be left at
these settings.
Note: Use of the Emergency command may not be appropriate for
patients who have an implanted defibrillator. Pacing in the
unipolar configuration may cause the defibrillator either to
deliver inappropriate therapy or to withhold appropriate therapy.
Tab le 2-1. Emergency Values
Pacing Mode
Rate
V. Refractory Period
V. Pulse Amplitude
V. Pulse Width
V. Sensitivity
V. Pace Polarity
V. Sense Polarity
Single Chamber Hysteresis
VVI
70 ppm
330 ms
7.5 V
1.5 ms
2.8 mV
Unipolar
Unipolar
Off
EMERGENCY
button appears in th e
lower left corner of all
function screens.
28
To program Emergency parameters:
1. Position the programming head over the device.
2. Select the [
EMERGENCY] button.
*
3. Hold the programming head steady until a confirmation
message appears. If programming is not confirmed, verify
that the programming head is properly positioned and then
reselect [
*
You can press the square red button on the left side of the display panel as an
alternative to the on-screen [EMERGENCY] button.
EMERGENCY].
InSync® Model 8040 Device Programming Guide 2-5
Interrogating the InSync Device
Before the programmer can display any information about the
status of the patient’s device system, you must interrogate the
device. The information you can retrieve by interrogating the
device falls into three categories:
1. Parameter settings
2. Real-time measurements of battery and lead data
3. Diagnostic data
As described below, you can retrieve this information all at once
or separately as it is needed.
The INTERROGATE ALL Function
The Interrogate All feature retrieves all three types of information
for use during the patient session. This feature may be most
helpful at the start of a patient session, but it can be used at
anytime during the session.
Note: The [
Pacing Parameters Screen.
INTERROGATE ALL] button is available only on the
To execute the Interrogate All command:
1. Select the Pacing Parameters screen.
Note: The Pacing Parameters screen is the first screen to
appear following model selection at the start of a patient
session.
2. Position the programming head over the device.
3. Select the [
programming head steady until success of the interrogation
is confirmed.
2-6 InSync® Model 8040 Device Programming Guide
29
INTERROGATE ALL] button. Continue to hold the
Auto Printout – An Interrogate All command automatically
initiates printing of the following data:
1) the present stimulating and diagnostic parameter settings,
2) a data summary report which includes an Event Summary, and
3) Battery/Lead status data.
Accumulated diagnostic data is not included in this printout.
Auto Save – Executing an Interrogate All command
automatically saves the present programmed parameter settings.
From a parameter programming screen, you can view the saved
values applicable to that screen (select the [
or you can recall the values to the screen as pending values for
programming (select the [
then select the [
SAVED VALUES] button).
SAVE/NOMINAL OPTIONS...] button,
SHOW SAVED] button)
The INTERROGATE Function
From most function screens, you can interrogate the device for the
data associated with that screen. Even when you have used the
Interrogate All feature, it may be necessary to perform additional
interrogations to update the programmer as you conduct the
patient session.
30
To execute the Interrogate command:
1. Position the programming head over the device.
2. Select the [
programming head steady until success of the interrogation
is confirmed.
INTERROGATE] button. Continue to hold the
InSync® Model 8040 Device Programming Guide 2-7
Canceling Effects of the Programming
Head Magnet
“Cancel Magnet” is a temporary programming command that
cancels the effect of the programming head magnet. It allows the
device to operate in its permanently programmed mode (such as
the DDD mode) while the programming head is held in position.
The [
CANCEL MAGNET] button appears near the lower right
corner of all function screens except the Battery/Lead screen
described in Chapter 4.
To execute the Cancel Magnet command:
1. While the programming head is positioned over the device,
select the [
2. Watch for the “Magnet cancelled” message.
CANCEL MAGNET] button.
Continue to hold the programming head in place for as long
as you want the magnet canceled. Lifting the programming
head terminates the Cancel Magnet function.
2-8 InSync® Model 8040 Device Programming Guide
31