Medtronic 2090 Programming Guide
MEDTRONIC CARELINK®
PROGRAMMER
Model 2090 Programmer for Medtronic and Vitatron Devices
Programmer Reference Guide
Caution: Federal Law (USA) restricts this device to sale by or on
the order of a physician.
2090 Programmer 0
Reference Guide 0
A guide for setting up and using the 2090 Programmer.
The following are trademarks of Medtronic:
Jewel, Marker Channel, Medtronic, Medtronic CareLink, CareLink, Paceart, Reveal,
SessionSync, and Vitatron
The following are trademarks of Microsoft:
Internet Explorer, Microsoft, Microsoft Office, Windows, and Windows XP
All other trademarks are the property of their respective owners.
Contents
Explanation of packaging and product symbols 9
About this guide 10
Summary of enhancements 11
1 Introduction to the Programmer 13
Description and intended use 14
Warnings 14
Precautions 15
Security Features for the Windows XP Operating System 17
Software requirements 18
Programmer functions 18
System components 21
Display screen features 28
2 Setting up the Programmer 33
Basic setup 34
Connecting peripheral devices 40
3 Updating Programmer software using the Software Distribution
Network 41
The Software Distribution Network 42
Connecting to the SDN using a dial-up connection 42
Connecting to the SDN using a wired network connection 49
Connecting to the SDN using a wireless network connection 52
Obtaining technical manuals 54
4 Conducting a patient session 55
Preparing for a patient session 56
Initiating a patient session 66
Ending a patient session 70
Storing components 70
5 Managing reports and data 73
Reports 74
Session data 74
Saving to a PDF file 74
Programmer Reference Guide
6
Contents
Saving to diskette 75
Saving to USB 75
Vitatron Manual-Guided Reset 77
Using Automatic SessionSync 77
Using Manual SessionSync for supported devices 78
SessionSync error message descriptions 79
6 Using printers 81
Using external printers 82
Installing printer paper 86
Printer buttons 87
Tearing off a printout 88
Low paper supply 88
7 Setting desktop preferences 89
About the between sessions tool palette 90
Adjusting Programmer time and date 92
Selecting audible tones 93
Changing the language setting 94
Improving the detection of pacing artifacts 94
Checking the software version 95
Starting the demonstrations option 96
Viewing and updating Programmer location and
hardware information 96
Selecting other software 98
Removing other software applications 98
8 Optional Software Features 99
SessionSync 100
9 Servicing the Programmer 107
Programmer Reference Guide
Cleaning the system components 108
Sterilizing the programming head, ECG cable, and
lead wires 108
Replacing a PC card 109
Programmer specifications 110
Special notice 114
Medtronic limited warranty 115
Index 117
Contents
7
Programmer Reference Guide
Explanation of packaging and product symbols
Explanation of packaging and product symbols
Refer to the package label and product to see which symbols
apply to this product.
Caution
Consult instructions for use
The product complies with both Canadian and U.S.
requirements for meeting UL safety standards.
Type BF applied part
Serial number
Storage temperature limitation
9
Off
On
Wireless communication enabled
Do not dispose of this product in the unsorted
municipal waste stream. Dispose of this product
according to local regulations. See
http://recycling.medtronic.com for instructions on
proper disposal of this product.
RF transmitter
Caution: Strong magnet
Alternating current
Programmer Reference Guide
10
About this guide
Manufacturer
Reorder number
Humidity limitation
Package contents
Programmer, software installed
Product documentation
Accessories
For U.S. audiences only.
About this guide
This guide describes the features and functions of the
2090 Programmer.
Summary of enhancements
As new capabilities are introduced to the Programmer and content
is revised in this guide, an overview to the changes will be noted
in this section. The changes are organized according to the
product release.
9986 (BOSS) Release 2.2
■
A USB flash drive may be connected and used in place of the
diskette drive, for Save to Disk and Read from Disk operations.
■
Save to PDF File is added to the list of Full Size printers. This
allows data such as printable reports and frozen strips to be
saved to PDF files on USB flash drives or diskettes.
Programmer Reference Guide
Summary of enhancements
■
The ability to remove applications that have Uninstall Software
capability has been added.
■
Indicators have been added to the task bar, to provide
information about USB flash drive and diskette drive
availability.
9986 (BOSS) Release 2.1
Operating System Migration
■
Using the integrated Ethernet, the 2090 Programmer is able to
connect to the Software Distribution Network and the Paceart
data management system using an Ethernet connection.
Graphics and text were updated to reflect the integrated
Ethernet connection.
■
USB ports allow software installation via a flash drive and
allow a printer to be connected to the 2090 Programmer.
Graphics and text were updated to reflect the USB ports.
■
On some Programmer platforms, the parallel connector has
been removed from the side of the Programmer. Text and
graphics have been updated to reflect this change.
■
Updated the symbols section.
11
Programmer Reference Guide
12
Summary of enhancements
9986 (BOSS) Release 2.0
Operating System Migration
■
Updated security information to include security
considerations for Windows-based Programmer.
■
Removed chapter on Remote View functionality, and revised
screen images to remove Remote View toolbar icon.
■
Added information on expanded use of USB ports for printing
and software installation and updating.
9986 (BOSS) Release 1.5
■
Using the 2091WB Wireless PC card, the 2090 Programmer
is able to connect to the Software Distribution Network and the
Paceart data management system using a wireless network
connection. Graphics and text were updated to reflect the
2091WB Wireless card.
■
Using the Ethernet/modem PC card, the 2090 Programmer is
able to connect to the Software Distribution Network and the
Paceart data management system using an Ethernet or
modem connection. Graphics and text were updated to reflect
the 2091 Ethernet/modem card.
■
Updated the Symbols section to include the Waste of
Electrical and Electronic Equipment (WEEE) symbol advising
customers of how to properly dispose of the Programmer.
■
Added a chapter to describe how to configure, enable and
disable SessionSync.
■
Added a description of how to access the Software
Distribution Network using a wireless network connection.
■
Added a description of how to access the Software
Distribution Network using an Ethernet connection to local
area network (LAN).
Programmer Reference Guide
Introduction to the Programmer1
Description and intended use 14
Warnings 14
Precautions 15
Security Features for the Windows XP Operating System 17
Software requirements 18
Programmer functions 18
System components 21
Display screen features 28
1
14
Chapter 1
Description and intended use
Description and intended use
The Medtronic/Vitatron Programmer is a portable, line-powered
(AC) microprocessor based system with software to interrogate
and program Medtronic and Vitatron implantable devices. Other
features include:
■
Automated software updates using a dial-up or local area
network (LAN) connection, depending on the hardware
configuration. This allows the Programmer to program new
devices and to provide new features as they become available.
■
A large, bright screen that is adjustable for viewing when
sitting or standing.
■
Keyboard to make entering information easier.
■
Fast printing speed of 50 mm per second on recorder paper.
■
ECG recording and diagnostic data reporting. Refer to the
technical manuals supplied with the software and hardware
accessories for specific details.
Note: The Programmer is not suited for use in the presence of a
flammable anaesthetic mixture.
Warnings
These warnings apply in general to using the Programmer for
programming implantable device parameter settings. Refer to the
reference guides for the implantable device and the Programmer
software for more information related to specific implantable
device models.
Warning: Do not modify this equipment without authorization from
Medtronic.
Programmer Reference Guide
Introduction to the Programmer
Precautions
Implantable device programming should be done only after careful
study of the reference guide for the implantable device and after
careful determination of appropriate parameter values based on
the patient’s condition and pacing system used. The implantable
device reference guide contains a complete description of
implantable device operation and important information, such as
indications for use, contraindications, warnings, and precautions.
The instructions contained in this reference guide and the
reference guide supplied with the Programmer software are
limited to the mechanics of setting up the Programmer and
selecting the correct options for the desired programming function.
Improper use of the Programmer could result in erroneous or
inadvertent programming and improper operation of telemetry and
measurement functions.
The Programmer also functions as a digital measuring device
intended for measurement of the pulse rate, AV interval, and pulse
width of implantable device artifacts as detected by skin
electrodes. Medtronic and Vitatron make no claims or warranties
as to the effectiveness of the Programmer as a diagnostic tool to
the physician.
The Programmer must be used only for programming Medtronic or
Vitatron implantable devices listed as applicable units for the
software being used. Direct stimulation through energy coupling
may occur if the Programmer is used on other implanted devices.
The Programmer is not compatible with programmable devices of
other manufacturers.
15
Precautions
This device has been tested for compliance to FCC regulations.
Changes or modifications of any kind not expressly approved by
Medtronic Inc., or Vitatron could void the user’s authority to
operate this device.
Programmer Reference Guide
16
Chapter 1
Precautions
Environmental precautions
To ensure safe and effective operation, use the device with care to
avoid damage to the Programmer from environmental factors that
may impair its function. Care is exercised in design and
manufacturing to minimize damage to devices under normal use.
However, electronic devices are susceptible to many
environmental stresses including, but not limited to, the following
examples.
■
The unit should not be dropped or mishandled in such a
manner as to cause physical damage to the unit. This may
impair device function. Even if the unit works immediately after
being dropped, operational damage may have occurred that
may not be observed until some future time.
■
Fluid should not be spilled on the unit. Even though care is
exercised in design and manufacture of the unit to minimize
leakage, fluid incursion may occur, which could impair
functioning of the unit.
■
The Programmer may be affected by electrostatic discharge
(ESD). In an environment likely to cause ESD, such as a
carpeted floor, you should discharge any charge collected on
your body before touching the device.
■
Electrically-operated medical devices, such as the
Programmer require special care (in terms of EMC) when
being installed. Refer to the accompanying insert:
Electromagnetic Compatibility Declaration.
■
Do not open the device. The Programmer is constructed to
minimize risk from environmental factors. Opening the unit
may make the unit susceptible to environmental factors.
■
Rapid temperature changes may affect proper operation.
Always allow the temperature to stabilize in the environment in
which the device is used before using the device.
■
Prolonged storage or operation of the device in high humidity
may affect proper operation.
If there is any concern that damage has occurred, the unit should
be returned to Medtronic or Vitatron for inspection and any
needed repair.
Besides these listed examples, various other environmental
factors may impair proper performance of the unit in the hospital
setting. Always use good health management practices to prevent
environmental damage to the unit.
Programmer Reference Guide
Introduction to the Programmer
Security Features for the Windows XP Operating System
Security Features for the Windows XP Operating System
The base operating system software for the 2090 Programmer is
being upgraded to an operating system based on Microsoft
Windows XP.
Changing to a popular operating system such as Windows XP will
allow Medtronic to develop software solutions more rapidly, and
provide updates to our system and applications much more easily.
The popularity of Windows XP has made it a common target for
threats including network attacks and viruses. In addition, many of
the features on the 2090 Programmer rely on connecting to a
hospital or clinic network. The great benefit of features that rely on
network connections comes with a slight increase in the possible
vulnerability of the 2090 Programmer to network-originated
threats.
What Medtronic is doing to ensure security on the 2090 Programmer
Medtronic has gone to great lengths to help ensure the safety and
reliability of the 2090 Programmer. The 2090 Programmer is
configured as a special purpose device, with no general purpose
access. Because unnecessary software components such as
Internet Explorer and Microsoft Office are common targets of
malicious attacks, those components are not installed on the 2090
Programmer.
17
The operating system portion of the internal hard disk is
write-protected. Each time the 2090 Programmer is restarted, it
starts in a known good state. Unsupported hardware, including
unsupported PCMCIA cards or USB devices, are ignored by the
operating system and cannot be accessed from the Programmer.
For wireless security, Medtronic now also supports WPA-PSK
(TKIP) in addition to WEP (Wired Equivalent Privacy).
Medtronic continues to work with its partners to analyze emerging
threats and evaluate potential impact on the 2090 Programmer.
Programmer Reference Guide
18
Chapter 1
Software requirements
What hospitals and clinics can do to ensure the security of
2090 Programmers
The most important step hospitals and clinics can take to minimize
the chance of the 2090 Programmer’s security being
compromised is to have a secure network. This includes firewalls
and security policies to keep the network, and any devices
connected to it, safe and free from security threats originating from
outside the network. Some threats, such as denial-of-service
attacks, which cause a targeted system to continually respond to
bogus network requests, can only originate and affect systems at
the local level. For wireless network connections, Medtronic
strongly recommends using the WPA-PSK wireless protocol.
What to do if you suspect the 2090 Programmer has been compromised
If you believe the 2090 Programmer has been compromised by a
security threat, turn off the Programmer, and disconnect it from the
network or remove the network card, then restart the system.
Contact Medtronic Technical Support for further assistance.
Software requirements
The Programmer requires software from Medtronic and Vitatron to
operate. Once installed, the software remains on the Programmer
hard drive.
Medtronic and Vitatron periodically update the software to add
functions to the Programmer. See Chapter 3, “Updating
Programmer software using the Software Distribution Network” on
page 41.
Programmer functions
The following list summarizes some of the Programmer functions.
Specific functions depend on the implantable device model being
programmed or monitored and the software installed.
Programmer Reference Guide
Programming functions:
■
Permanent and temporary adjustment of parameter values.
■
Selection of nominal parameter values established by
Medtronic, Vitatron or by the user.
■
Emergency buttons for VVI pacing.
Telemetry functions:
■
Automatic detection of the device model, and automatic
application start-up, if the programming head is in proper
position when the Programmer is turned on.
■
Automatic confirmation of a programmed change.
■
Reporting of currently programmed parameter values in effect
and battery status of the implanted device.
■
Reporting of real-time measurements of implantable device
operating parameters such as battery voltage, output
energy, etc.
■
Display and printout of Marker Channel telemetry to simplify
EGM analysis.
■
Display and printout of an atrial and/or ventricular intracardiac
electrogram (EGM) taken from the electrodes of the
implantable device lead system.
Introduction to the Programmer
Programmer functions
19
ECG and other diagnostic functions:
■
ECG window on programming and telemetry data screens
provides a continuous view of the patient’s ECG.
■
Full-window ECG display including a freeze option and an
amplitude adjustment feature; ECG display includes Marker
Channel telemetry, EGM waveforms, or both when available.
■
Continuous multi-channel recording (ECG and Marker
Channel telemetry or ECG and EGM, for example).
■
Stimulation threshold test functions.
■
Direct measurement of pulse rate, AV interval, and
pulse width.
■
Temporary implantable device inhibition.
■
Printout of programmed and measured information for
permanent record.
Programmer Reference Guide
20
Chapter 1
Programmer functions
Software update function:
■
Automatic update and installation of application software via a
dial-up or network connection to the Medtronic Software
Distribution Network.
■
Updates available from the Software Distribution Network on a
24 hour/7 day per week basis.
■
Updates available from Medtronic personnel.
■
Clinical software applications that have Uninstall Software
capability may be removed using the Programmer Desktop.
Programmer Reference Guide
System components
Figure 1-1. Programmer components - front view
V
V
I
2
Introduction to the Programmer
System components
1
21
9
10
12
1Display screen
2 Emergency VVI
button
3 Microphone jack
4 Headphone jack
8
7
5 Keyboard cover
6 Keyboard
7 Printer controls
8 Telephone cord
(not supplied)
11
3
4
5
16
6
15
14
13
17
9 Printer paper
10 Programming
head (ordered
separately)
11 Touch pen
12 Electrode leads
13 ECG cable
with plug
14 Reference guide
15 Disk drive, PC
card cover
16 Power cord
17 Ethernet cable
(not supplied)
Programmer Reference Guide
22
Chapter 1
System components
Note: Only accessories approved by the manufacturer should
be used.
Display screen – 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 – Select 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 modem to a
telephone jack. The telephone cord must be 26 wire gauge
minimum. (Not supplied by Medtronic.)
Ethernet cable – Used to connect the Programmer to the clinic’s
network. The Ethernet cable must be Category 5 or better. (Not
supplied by Medtronic.)
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 a program or
interrogate operation. (Ordered separately; not supplied with
Programmer.)
Programmer Reference Guide
Introduction to the Programmer
System components
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 color-coded 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 – Programmer Reference Guide, provides
information about setting up the Programmer and between
session features.
Disk drive, PC card cover – Provides access to the disk drive
and the PC card. If applicable to your Programmer hardware, also
provides access to USB port(s) and either Integrated Ethernet or
parallel connector.
23
Power cord – Connects the Programmer to an AC power outlet.
Figure 1-2. Front connectors (keyboard turned up)
1 Programming head (yellow marker)
2 Analog Input/Output (green marker)
3 ECG cable (black or blue marker)
Programming head – The programming head connector has a
yellow marker.
3
1
2
Programmer Reference Guide
24
Chapter 1
System components
Analog Input/Output – Allows an external monitor or recorder to
be connected to the Programmer. This connector has a
green marker.
ECG cable – Connects the ECG cable to the Programmer. This
connector has a black or blue marker.
Figure 1-3. Left view
1
2
1 ON/OFF switch
2Cooling fan
3
4
3 Expansion slot
4Printer
ON/OFF switch – Controls power (AC) to the Programmer. Once
the Programmer is turned off, wait 2 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 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 can print out a continuous ECG with
accompanying Marker Channel telemetry, EGM, or both when
available.
Programmer Reference Guide
Figure 1-4. Right view
Introduction to the Programmer
System components
25
1
1 Disk drive, PC card cover
2 Infrared window
2
Disk drive, PC card cover – Provides access to the disk drive
and the PC card. If applicable to your Programmer hardware, also
provides access to USB port(s) and either Integrated Ethernet or
parallel connector.
Infrared window – Intended for future use.
Programmer Reference Guide
26
Chapter 1
System components
Figure 1-5. Disk drive, PC card cover open (two variations of
Programmer hardware are shown)
1 2
3
1PC card slot
2 Parallel connector
3 Disk drive
1
2
1PC card slot
2 Disk drive
3 Integrated Ethernet
4 USB port
4
3
PC card slot – There are different types of PC cards that can be
plugged into the PC card slot:
■
The Modem card.
■
The Combination Ethernet/Modem Network card, referred to
as the combo card.
■
The Wireless Ethernet card, referred to as the Wireless card.
These PC cards can be used to connect to the Software
Distribution Network, to transfer information using SessionSync
(provided it is supported by the device), and for connecting the
Programmer to a consultant’s computer.
Warning: When using a modem or combo card, it is the
responsibility of the user to ensure that the telecom voltage does
not exceed 125 V.
Programmer Reference Guide
Introduction to the Programmer
System components
Parallel connector – Allows a printer to be connected to the
Programmer.
Disk drive – Accommodates a 3.5 inch (90 mm) formatted
diskette that is IBM-compatible. It can have a capacity of either
720 Kb (DS, DD) or 1.44 Mb (DS, HD).
Integrated Ethernet – Allows the Programmer to connect to the
Software Distribution Network and the Paceart data management
system using an Ethernet connection.
Figure 1-6. Back view (power cord door open)
27
1
2
1 USB port(s)
2 VGA output port
3
3Power cord
USB port(s) – Allows installation of software, software updates,
and future device application installations. The USB port can also
be used to connect to a USB printer or a USB storage device.
VGA output port – Allows 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.
Power cord – Connects the Programmer to line (AC) power.
Programmer Reference Guide
28
Chapter 1
Display screen features
Display screen features
The Programmer display screen is an interactive device that
displays text and graphics. It is also a control panel that displays
buttons and menu options that you can select using the touch pen.
Features and conventions of the display screen
This section provides an overview of the features of the display
screen. For more information, refer to the reference guide for the
implanted device. Figure 1-7 shows the main elements of the
typical screen. Vitatron display screens may be different; see the
reference guide for the implanted device. If you see a
button, select it to display the Vitatron Select Model screen.
Figure 1-7. Main elements of a display screen example
1
2
3
4
5
1Task bar
2 Status bar
3 Live Rhythm Monitor window
4 Task area
Programmer Reference Guide
7
6
5 Command bar
6 Buttons
7 Tool palette
Introduction to the Programmer
Display screen features
Task bar
The task bar can contain these icons/indicators:
Tabl e 1 -1 . Task bar icons/indicators
Icon Name Function
Position head
light array
Turns green to indicate successful
communication between the programming
head and the device. The greater the
number of green bars on the array, the
better the communication. A minimum of
two green bars should be lit.
29
SessionSync icon Provides information about the connection
Analyzer
indicator/selector
Device
indicator/selector
and data transfer status between the 2090
Programmer and the data management
system. SessionSync is an optional
feature. If your device does not support
SessionSync, a red symbol will be
superimposed over the icon. Refer to the
topic “SessionSync” on page 100 for
detailed information.
Used to start an analyzer session or, if
your device supports concurrency, to
switch to an analyzer session from a
device session. When an analyzer session
is running, the indicator box turns green.
(For more information on the Analyzer,
see the 2290 Analyzer Reference Guide.)
Used to go to the Select Model screen on
the Programmer desktop or, if your device
supports concurrency, to switch to a
device session from an analyzer session.
When a device session is running, the
indicator box turns green.
Programmer Reference Guide
30
Chapter 1
Display screen features
Tab le 1- 1. Task bar icons/indicators
USB indicator Turns green to indicate USB storage
device is available for saving PDF reports
and patient data. When USB indicator is
green, diskette is not available. When
inserting a USB device, a slight delay
occurs before device is available for use.
Diskette indicator Turns green to indicate diskette drive is
available for saving PDF reports and
patient data. When diskette indicator is
green, USB is not available.
Status bar
Before selecting a model, the status bar has no information. For
specific information about the status bar, refer to the reference
guide for the implanted device. After model selection, the status
bar may include:
■
The present pacing mode.
■
Test condition status.
■
The device model.
1
1 Status bar
Live Rhythm Monitor window
This window is a partial view of the full-screen display of the ECG,
and contains a Status bar and a Waveform adjustment bar that lets
you make changes to the waveform display. 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
After model selection, Marker Channel and telemetered EGM
waveform traces may be available.
Programmer Reference Guide
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