ENPULSE
E1DR00/20 Series
E2VDD00 Series
E2SR00 Series
Vision
Programmer Software Model 9991
TM
Pacemaker Programming Guide
Caution: Federal law (USA) restricts this device to sale by or on
the order of a physician or properly licensed practitioner.
EnPulse Pacemaker Programming
Guide
A guide to using the 9790/C and
2090 programmers with EnPulse
pacemakers
Refer to the EnPulse Pacemaker
Reference Guide for information on the
pacemakers.
The following are trademarks of Medtronic:
Capture Management, Checklist, Fast Path, EnPulse, Implant Detection, Key Parameter History, Marker
Channel, Medtronic, Medtronic Carelink, Rate Profile Optimization, Remote Assistant, Auto-PVARP,
Quick Look II, Search AV+, Sensing Assurance, Observations, Sinus Preference, and Vision.
How to use this guide
Information is contained in two guides
Product information about EnPulse software and pacemakers is
presented in two separate guides.
The Pacemaker Programming Guide (PPG) accompanies EnPulse
software and contains instructions on how to use the programmer and the
programming software.
The Pacemaker Reference Guide (PRG) provides detailed information on
EnPulse pacemakers.
About the Pacemaker Programming Guide
The Pacemaker Programming Guide presents the following information to
use the 9790/C and 2090 programmers.
■
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 use checklist to streamline a follow-up session.
■
How to view and print the patient’s ECG and EGM waveform traces.
■
How to configure the pacemaker 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.
■
How to run EP Studies.
How to use this guide
EnPulse Pacemaker Programming Guide v
How to use this guide
About the Pacemaker Reference Guide
The Pacemaker Reference Guide describes in detail, how the pacemaker
operates and specifies the capabilities of each model.
■
Describes 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 the pacemaker operation.
■
Contains troubleshooting information for electrical and hemodynamic
problems.
■
Specifies parameter and data collection capabilities, longevity
projections, and mechanical and electrical specifications.
■
Provides general warnings and cautions, potential interference
sources, and general indications for pacing.
■
Contains a glossary of terms.
vi EnPulse Pacemaker Programming Guide
Table of contents
Table of contents
How to use this guide v
1. Setting up the programmer
Operating differences between the 9790/C and 2090
programmers 1-2
The 2090 programmer system components 1-5
The 9790/C programmer system components 1-11
Connecting an external printer 1-15
Connecting peripheral devices 1-19
The display screen 1-23
2. Using the programmer
Setting programmer preferences 2-2
About the Checklist feature 2-7
Using Checklist 2-8
Creating a custom checklist 2-9
Connecting the programmer to skin electrodes 2-13
Positioning and using the programming head 2-14
Programming Emergency parameters 2-19
Recording an ECG strip 2-21
Using the On-line Help feature 2-24
3. Conducting a patient session
Programmer features 3-2
Automatically adapting parameters 3-2
Starting a patient session 3-4
Proceeding with session tasks 3-11
Interrogating the pacemaker 3-16
Taking a quick look at pacemaker operation 3-17
Viewing Battery and Lead Measurements 3-22
Checking the present parameter settings 3-25
Viewing and programming patient information stored in the
pacemaker 3-26
Recording an ECG Strip of magnet operation 3-27
Checking the patient’s Underlying Rhythm 3-30
Printing reports 3-33
Saving session data on a diskette 3-36
Ending a patient session 3-38
4. Viewing the patient’s ECG and EGM traces
Viewing the ECG and other rhythm waveforms 4-2
EnPulse Pacemaker Programming Guide vii
Table of contents
Adjusting and arranging the waveform traces 4-7
Freezing and analyzing a waveform strip 4-16
Recalling and viewing waveform strips 4-24
5. Collecting diagnostic data
About diagnostic data collection 5-2
Viewing the collected data 5-8
The automatically collected data displays 5-11
Clinician-selected detailed data displays 5-30
Programming data collection options 5-45
Clearing data from the pacemaker 5-47
6. Evaluating parameter settings
Measuring stimulation thresholds 6-2
Determining a sensitivity setting 6-22
Using temporary programming to evaluate parameter settings 6-30
7. Programming pacemaker parameters
Programming parameters 7-2
Saving/retrieving a set of parameter values 7-15
Retrieving Key Parameter History information 7-18
8. Rate Response setup
Using Exercise test to verify Rate Response 8-2
9. Using the EP Studies function
About the EP Studies function 9-2
Starting the EP Studies function 9-10
Setting up and executing a PES protocol 9-16
Setting up and executing a Burst protocol 9-21
Setting up and executing a VOO Burst 9-25
PES parameter definitions and values 9-27
Burst parameter definitions and values 9-30
A. Appendix: Parameter values and restrictions
Programmable modes and parameters A-2
Automatic and clinician-selectable diagnostics A-12
Programming restrictions A-17
B. Appendix: Implant information
Warnings B-2
Precautions B-5
Device operation B-11
Device information B-14
viii EnPulse Pacemaker Programming Guide
I. Index
Table of contents
EnPulse Pacemaker Programming Guide ix
Setting up the programmer
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 chapter briefly explains the components associated with
the 9790/C and 2090 programmers. This chapter also
includes information on connecting an external printer,
connecting peripheral devices, and using the display screen.
For more detailed information on setting up your
programmer, refer to your programmer manual.
1
Operating differences between the
9790/C and 2090 programmers 1-2
The 2090 programmer system
components 1-5
The 9790/C programmer system
components 1-11
Connecting an external printer 1-15
Connecting peripheral devices 1-19
The display screen 1-23
EnPulse Pacemaker Programming Guide 1-1
Setting up the programmer
Operating differences between the 9790/C and 2090 programmers
Operating differences between the 9790/C and 2090
programmers
Medtronic pacemakers (IPGs) can be programmed with either the
Model 9790/C programmer or Medtronic CareLink programmer
(Model 2090). There are operating differences between the Model 9790/C
and Model 2090 programmers.
The major operating differences between the Model 9790/C and the 2090
programmers include:
■
Display screen changes
■
Calibration button
■
Built-in keyboard
Display screen changes
■
A task bar has been added at the top of the screen on the
Model 2090 programmer. It includes two new indicators:
– Position Head Light Array
– Remote View icon
Refer to the Medtronic CareLink Programmer Reference Guide for
complete information on these features.
■
Additional waveform display. (This display screen change applies
only to Vision software applications.)
All screens display an additional waveform. For example, if a screen
displays two waveform on the Model 9790/C programmer, this screen
displays three waveforms on the Model 2090 programmer.
1-2 EnPulse Pacemaker Programming Guide
Operating differences between the 9790/C and 2090 programmers
Setting up the programmer
1
2
3
3
1 Task Bar with Position Head Light Array
2 Remote View icon
3 Live Rhythm Monitor window
Figure 1-1. Additional display screen features of the Model 2090
programmer
Select Model screen
For pacemaker applications, the [Nominals...] button is inactive for Vision
software.
Calibrate button
The Calibrate button1 is located on the Adjust button menu (when this
menu is available) on the Model 2090 programmer. To add a reference
signal to the waveform, place the touch pen on the Calibrate button (see
Figure 1-2).
1
1 The Calibrate button is located on the Adjust... menu.
Figure 1-2. Calibrate button
1
For Vision software applications.
EnPulse Pacemaker Programming Guide 1-3
Setting up the programmer
Operating differences between the 9790/C and 2090 programmers
Built-in keyboard operation
The Model 2090 programmer includes a built-in keyboard which is active
only when the on-screen keyboard is displayed.
Tap the touch pen outside the area of the keyboard to inactivate the
on-screen keyboard. When the soft keyboard is inactive, the hard
keyboard is also inactive.
1-4 EnPulse Pacemaker Programming Guide
The 2090 programmer system components
Setting up the programmer
The 2090 programmer system components
1
VVI
2
4
8
3
9
10
12
1 Display screen
2 Emergency
VVI button
3 Microphone jack
4 Headphone jack
7
15
6
11
5 Keyboard cover
6 Keyboard
7 Printer controls
8 Telephone cord
9 Printer paper
10 Programming head
11 Touch pen
12 Electrode leads
13 ECG Cable with Plug
Figure 1-3. Programmer components - front view
16
5
14
13
14 Reference guide
15 Disk drive,
Modem cover
16 Power cord
EnPulse Pacemaker Programming Guide 1-5
Setting up the programmer
The 2090 programmer system components
Note: Only accessories approved by the manufacturer should be used.
Display screen – The display can be positioned smoothly from closed to
nearly horizontal. Programming options are selected on the screen with
the touch pen.
Emergency VVI button – Used to deliver bradycardia VVI operation.
Microphone jack – Intended for future use.
Headphone jack – Intended for future use.
Keyboard cover – Slides forward to protect the keyboard.
Keyboard – Used to enter information.
Printer controls – Selects paper speeds of 12.5, 25, or 50 mm/s. Push a
button once to select printing speed. Push it again to stop printing. The
Paper Advance button allows the user to properly align the paper.
Telephone cord – Connects the programmer’s modem to a telephone
jack. The telephone cord must be 26 wire gauge, minimum.
Printer paper – Paper for the internal printer.
Programming head – Provides the communication link between the
programmer and the patient’s implantable device. The programming head
contains a strong permanent magnet, radio-frequency (RF) transmitter
and receiver, and light array. It must be held over the implantable device
during programming or interrogation.
Touch pen – Used to select options on the display screen.
Predetermined options are selected by applying the pen to the screen.
Electrode leads / ECG cable – Connects the programmer to skin
electrodes on the patient for ECG and measurement functions requiring
surface detection of cardiac and implantable device signals. Five colorcoded lead wires connect the cable to standard, disposable skin
electrodes applied to the patient.
Note: If you received a five-lead cable with a plug, the plug can be
removed for five-lead ECG applications.
Reference guide – The 2090 Programmer Reference Guide provides
information about setting up the programmer and between session
features.
1-6 EnPulse Pacemaker Programming Guide
The 2090 programmer system components
Setting up the programmer
Disk drive, Modem cover – Provides access to the disk drive, modem,
and parallel connector.
Power cord – Connects the programmer to an AC power outlet.
1 Programming head port (yellow marker)
2 Analog input/output port (green marker)
3 ECG cable port (black marker)
Figure 1-4. Front connectors (keyboard turned up)
Programming head port – Programming head connector. This
connector has a yellow marker.
Analog input/output port – Allows an external monitor or recorder to be
connected to the programmer. This connector has a green marker.
ECG cable port – Connects the ECG Cable to the programmer. This
connector has a black marker.
1
2
3
EnPulse Pacemaker Programming Guide 1-7
Setting up the programmer
The 2090 programmer system components
1
2
1 ON/OFF switch
2 Cooling fan
3
4
3 Expansion slot
4 Printer
Figure 1-5. Left view
ON/OFF switch – Controls power (AC) to the programmer. Once the
programmer is turned off, wait two seconds before turning it on again.
Cooling fan – Internal fan provides continuous airflow to prevent the
internal circuitry from overheating.
Expansion slot – Allows for additional features to be added, such as the
2290 analyzer that is available as an option.
Printer – Integral thermal printer with text and graphic output capabilities.
According to the selected function, the printer provides data reports, or it
prints out a continuous ECG with accompanying Marker Channel
telemetry, EGM, or both when available.
1-8 EnPulse Pacemaker Programming Guide
1
1 Disk drive, Modem cover
2 Infrared window
The 2090 programmer system components
Setting up the programmer
2
Figure 1-6. Right view
Disk drive, Modem cover – Provides access to the disk drive, modem,
and parallel connector.
w
Infrared window – Intended for future use.
2
1
1 Modem
2 Parallel connector
3 Floppy disk drive
3
Figure 1-7. Disk drive, Modem cover open
Modem – Intended for software updates and linking the programmer to a
consultant’s computer.
Warning: It is the responsibility of the user to ensure that the telecom
voltage does not exceed 125 V.
Parallel connector – Allows a printer or CD ROM drive to be connected
to the programmer.
EnPulse Pacemaker Programming Guide 1-9
Setting up the programmer
The 2090 programmer system components
Floppy disk drive – 3.5 inch formatted diskette that is IBM-compatible.
It can have a capacity of either 720 Kb (DS, DD) or 1.44 Mb (DS, HD).
#
2
3
1
1 USB port
2 VGA Output port
Figure 1-8. Back view (power cord door open)
USB port – Intended for future use.
VGA Output port – On some models of programmer the VGA port can
be used in porting the screen image of the programmer to an external
VGA monitor or for conversion of the output signal to NTSC/PAL format for
presentation on a television monitor. Please contact Medtronic Technical
Services at 1-800-328-2518 for technical guidance.
Caution: To protect against interference or surge/leak currents, the use
of a secondary VGA monitor that meets an applicable safety standard
such as UL 60950 or IEC 60950 is strongly recommended.
3 Power cord
Power cord – Cord connects the programmer to line (AC) power.
1-10 EnPulse Pacemaker Programming Guide
The 9790/C programmer system components
Setting up the programmer
The 9790/C programmer system components
1
2
3
4
5
1 Position head light
2 Emergency button
3 Deliver button
4 Printer controls
Figure 1-9. External components - front view
6
7
8
5 Display panel
6 Touch pen
7 ECG cable
8 Programming head
Programming head – Provides the communication link between the
programmer and the patient’s implantable device. The programming head
contains a strong permanent magnet, radio-frequency (RF) transmitter
and receiver, and Light Array. It must be held over the implantable device
during a program or interrogate operation.
EnPulse Pacemaker Programming Guide 1-11
Setting up the programmer
The 9790/C programmer system components
ECG cable – Connects the programmer to skin electrodes on the patient
for ECG and measurement functions requiring surface detection of
cardiac and implantable device signals. Five color-coded lead wires
connect the cable to standard, disposable skin electrodes applied to
the patient.
Touch pen – Used to select programming options on the display screen.
Options are selected by applying the pen to the screen.
Display panel – Flat panel display with nine adjustable positions ranging
from nearly horizontal (15°) to vertical (90°). Programming options are
selected on the screen with the touch pen.
Position head light – Dual color (amber/green) light works with the
programming head to indicate when a valid communication link to the
implantable device exists. An amber colored light indicates no link. When
the light goes off, or green, the programming head is positioned and can
transmit and receive data. Use of the programming head Light Array is
described on page 2-15.
Emergency button – Used to deliver bradycardia VVI operation, or with
the Deliver Button, to deliver a tachycardia therapy.
Deliver button – Used with the Emergency Button to deliver tachycardia
therapies, which include a defibrillation shock.
Printer controls – Select paper speeds of 12.5 or 25 mm/s. Push a
button once to select printing speed. Push it again to stop printing. The
Paper Advance button allows you to properly align the paper.
1
2
1 On/Off switch
2 Cooling fan
3 Printer
Figure 1-10. External components - left view
1-12 EnPulse Pacemaker Programming Guide
3
The 9790/C programmer system components
Setting up the programmer
Printer – Integral thermal printer with text and graphic output capabilities.
Depending upon the selected function, the printer provides data reports,
or it prints a continuous ECG with accompanying Marker Channel
telemetry or EGM.
On/Off (1/0) switch – Controls power (AC) to the programmer. Once the
programmer is turned off, five seconds should pass before turning it on
again.
Cooling fans – Internal fans provide continuous airflow to prevent the
internal circuitry from overheating. Air is taken in from the front and right
side and expelled out the left side.
1
2
1 Calibration button
2 Analog Output
3 PCMCIA access
4 Disk drive
Figure 1-11. External components - right view
Disk drive – Used to install the software that operates the programmer.
The disk drive accepts 3.5 inch diskettes. Once installed, software is
permanently stored on an internal hard disk drive. Also used for save-todisk and DMR-to-disk operations.
PCMCIA access – Personal Computer Memory Card International
Association compartment containing two ports for future use.
Analog Output – Provides four analog signals: ECG, Marker Channel
telemetry, EGM, and software application specific waveforms.
Calibration button – Used to calibrate the external device connected to
the Analog Output.
4
3
EnPulse Pacemaker Programming Guide 1-13
Setting up the programmer
The 9790/C programmer system components
1
3
2
1 Power cord
2 Input/Output ports
3 AC Power Input
Figure 1-12. External components - back view (power cord door removed)
AC Power Input – Receptacle for connecting the power cord.
Power cord – Cord connects the programmer to line power.
Input/Output ports: Keyboard, Parallel, Serial, and VGA – Currently,
the input/output ports are for Medtronic use only. When customer
applications for these ports are implemented, specific instructions will be
provided in the software manuals.
1-14 EnPulse Pacemaker Programming Guide
Connecting an external printer
Connecting a compatible printer to the programmer allows you to print full,
page-size reports of session data when available (see the reference guide
for the implanted device). This section describes how to connect a printer
to your programmer.
Setting up the programmer
Connecting an external printer
w
Warning: Peripheral equipment connected to the programmer must be
certified according to the applicable IEC standards (IEC 60950 for data
processing equipment and IEC 60601-1 for medical equipment). The
system formed by connecting peripheral equipment to the programmer
must comply with IEC 60601-1-1 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 60950 at least two meters
away from the patient. Contact the peripheral equipment manufacturer for
information about IEC certification.
Printers listed by this software are certified to IEC 60950 (based on
information provided by the manufacturers) except the Canon BJC-1000,
OKI Okipage 10ex, Samsung QwikLaser 6050, and the Xerox DocuPrint
P8ex. Only printers listed by this software may be connected to
the programmer.
Printer compatibility
The programmer supports a number of printers as indicated by the printer
options accessible on two software screens:
■
Session Preferences (see “To set up printing preferences” on
page 3-13)
■
Print Queue screen (see Figure 1-13)
Note: The print queue during a session lists print jobs for that session
only. See “Printing reports held in the Print Queue” on page 3-35 for more
information.
EnPulse Pacemaker Programming Guide 1-15
Setting up the programmer
Connecting an external printer
Available Reports
Print Queue
Printer field
Figure 1-13. Session Print Queue screen
If you are not conducting a patient session, select the Print Queue icon.
The printer that you connect to the programmer must be compatible with
one of the printer drivers listed. If your printer is not listed, refer to the
manual you received with your printer to see if it emulates (uses the same
“driver”) as one of those listed.
Materials you will need
To connect a printer to the programmer, you will need a Parallel Interface
printer cable. One end of the cable must fit the parallel interface port on
your printer. The other end of the cable must be a standard 25-pin male D
connector. To connect a printer to the 9790/C programmer, you will also
need a small Phillips screwdriver to open the parallel port access panel
on the back of the programmer.
Connecting the printer
Before connecting a printer to your programmer, you should exit the
patient session and turn the programmer off.
1-16 EnPulse Pacemaker Programming Guide
Setting up the programmer
Connecting an external printer
To connect a printer to your 2090 programmer
1
1 Parallel connector
Figure 1-14. Parallel connector
Procedure
1. Locate the Modem, Disk drive cover on the right side of the
programmer. Open the cover by pushing down on the small latch at
the top center of the panel.
2. Connect the printer cable to the parallel connector on the
programmer.
3. Connect the other end of the cable to the printer.
4. Connect the printer power cord to an outlet and turn the printer on.
Make sure that there is paper in the printer.
Note: Refer to the technical information provided with your printer
for information about connecting and operating the printer.
5. Turn the programmer on, and select the Print Queue icon.
Note: Be sure to select the correct printer driver from the options
listed when you select the Printer field on the Print Queue window.
You are now ready to use your programmer with the connected
printer.
EnPulse Pacemaker Programming Guide 1-17
Setting up the programmer
Connecting an external printer
To connect a printer to your 9790/C programmer
1. Locate the parallel port access panel on the back of the
programmer.
2. Remove the small Phillips head screw in the upper right corner of
the access panel.
3. Open the access panel by pushing downward on the small latch at
the top center of the panel.
4. Connect the printer cable to the parallel port on the programmer.
1
2
1 Parallel port
2 Printer cable
Figure 1-15. Connect the printer to the programmer
5. Connect the other end of the cable (if it is not already connected) to
the printer.
6. Connect the printer power cord to an appropriate power outlet, and
turn the printer on. Make sure that the printer has been loaded with
paper.
Note: Refer to the technical information provided with your printer for
information about connecting and operating the printer.
7. Turn the programmer on, and select the Print Queue icon.
1-18 EnPulse Pacemaker Programming Guide
From the Print Queue window, be sure to select the correct printer driver
from the options listed when you select the Printer field. You are now
ready to use your programmer with the connected printer. Refer to
“Printing reports” on page 3-33 for instructions on printing session
reports.
Connecting peripheral devices
An analog input/output connector allows the use of a peripheral isolated
medical grade recorder or monitor. A special adapter accessory (not
included with the programmer) is needed to use the input/output
connector. For a 9790/C series programmer, use a 9790AB analog
input/output cable, and for a 2090 programmer, use a 2090AB analog
input/output cable. Contact your Medtronic representative for more
information. The signals present at the output depend on the software
application but may include the following:
■
ECG
■
Marker Channel telemetry
■
EGM
■
Software specific waveforms
Setting up the programmer
Connecting peripheral devices
All electronic devices that are connected to the programmer must meet
the electrical safety requirements of IEC-60950.
EnPulse Pacemaker Programming Guide 1-19
Setting up the programmer
Connecting peripheral devices
Locating the peripheral device connector on a 2090 programmer
1
Connector type: BNC
Output signal: ± 1 Volt or ± 5mV
(switchable)
Signal Output Adaptor
A
B
C
D
E
2090AB
1
2
2
Adaptor output signals (after model selection):
A - Patient’s ECG (uppermost ECG on display)
B - Telemetered EGM (uppermost EGM on display)
Adaptor input signals (after model selection):
1 - Intended for future use
2 - Intended for future use
C - Telemetered EGM (other EGM if programmed)
D - Marker Channel Telemetry
E - Intended for future use
1 Analog Input/Output connector with green marker (under the keyboard)
2 Model 2090AB Analog Input/Output adaptor
Figure 1-16. Analog Input/Output connector
1-20 EnPulse Pacemaker Programming Guide
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