Medtronic 2090 Programming Guide

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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, Paceart, Reveal, SessionSync,

and Vitatron

The following are trademarks of Microsoft: Internet Explorer, Microsoft, Microsoft Office, Windows, and Windows XP

Explanation of packaging and product symbols 7

About this guide 8

Summary of enhancements 8

1 Introduction to the Programmer 11

Description and intended use 12

Warnings 12

Precautions 13

Security Features for the Windows XP Operating System 15

Software requirements 16

Programmer functions 16

System components 19

Display screen features 26

2 Setting up the programmer 31

Basic setup 32

Connecting peripheral devices 38

3 Updating programmer software using the Software Distribution

Network 39

The Software Distribution Network 40

Connecting to the SDN using a dial-up connection 40

Connecting to the SDN using a wired network connection 47

Connecting to the SDN using a wireless network connection 50

Obtaining technical manuals 52

4 Conducting a patient session 53

Preparing for a patient session 54

Initiating a patient session 64

Ending a patient session 68

Storing components 68

5 Using printers 71

Using external printers 72

Installing printer paper 76

Printer buttons 77

Programmer Reference Guide

Contents

Tearing off a printout 78

Low paper supply 78

6 Setting desktop preferences 79

About the between sessions tool palette 80

Adjusting programmer time and date 82

Selecting audible tones 83

Changing the language setting 84

Improving the detection of pacing artifacts 84

Checking the software version 85

Starting the demonstrations option 86

Viewing and updating programmer location and hardware information 86

Selecting other software 88

7 Optional Software Features 89

SessionSync 90

8 Servicing the Programmer 97

Cleaning the system components 98

Sterilizing the programming head, ECG cable, and lead wires 98

Replacing a PC card 99

Programmer specifications 100

Special notice 104

Medtronic limited warranty 105

Programmer Reference Guide

Explanation of packaging and product symbols

Refer to the package label and product to see which symbols apply to this product.

0123

Conformité Européenne (European Conformity). This symbol means that the device fully complies with

0123

0344

European Directive AIMD 90/385/EEC (NB 0123) and R&TTE Directive 1999/5/EC.

The use of this device might be subject to individual country licensing regimes in Europe.

Conformité Européenne (European Conformity). This symbol means that the device fully complies with European Directive AIMD 90/385/EEC (NB 0123).

Conformité Européenne (European Conformity). This symbol means that the device fully complies with European Directive AIMD 90/385/EEC (NB 0344).

Caution: Consult accompanying documents

Consult instructions for use

System meets the applicable Canadian [C22.2-60601.1-M90 (R2001)] and US (UL 60601-1:2003) electrical safety standard requirements.

Type BF equipment

Serial number

Temperature limitation

Programmer Reference Guide

About this guide

Off

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.

Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.

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 2.1 Operating System Migration

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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.

Programmer Reference Guide

Summary of enhancements

■

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.

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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.

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Updated the symbols section.

9986 (BOSS) Release 2.0 Operating System Migration

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Updated security information to include security considerations for Windows-based programmer.

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Removed chapter on Remote View functionality, and revised screen images to remove Remote View toolbar icon.

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Added information on expanded use of USB ports for printing and software installation and updating.

9986 (BOSS) Release 1.5

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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.

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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.

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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.

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Added a chapter to describe how to configure, enable and disable SessionSync.

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Added a description of how to access the Software Distribution Network using a wireless network connection.

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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 12

Warnings 12

Precautions 13

Security Features for the Windows XP Operating System 15

Software requirements 16

Programmer functions 16

System components 19

Display screen features 26

Chapter 1

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:

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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.

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A large, bright screen that is adjustable for viewing when sitting or standing.

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Keyboard to make entering information easier.

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Fast printing speed of 50 mm per second on recorder paper.

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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.

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.

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

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.

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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.

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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.

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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.

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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.

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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.

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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.

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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

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 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 a Class III medical device, so it is configured as a special purpose device, with no general purpose access. Unnecessary operating system components such as Internet Explorer, or desktop tools such as Microsoft Office, which are common targets of malicious attacks, have been removed from the operating system installed on the 2090 Programmer.

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

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’s 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 39.

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:

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Permanent and temporary adjustment of parameter values.

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Selection of nominal parameter values established by Medtronic, Vitatron or by the user.

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Emergency buttons for VVI pacing.

Telemetry functions:

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Automatic detection of the device model and application start-up occurs if the programming head is in proper position when the programmer is turned on.

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Automatic confirmation of a programmed change.

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Reporting of currently programmed parameter values in effect and battery status of the implanted device.

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Reporting of real-time measurements of implantable device operating parameters such as battery voltage, output energy, etc.

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Display and printout of Marker Channel telemetry to simplify EGM analysis.

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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

ECG and other diagnostic functions:

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ECG window on programming and telemetry data screens provides a continuous view of the patient’s ECG.

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Full-window ECG display includes a freeze option and an amplitude adjustment feature. The full-width ECG display includes Marker Channel telemetry, EGM waveforms, or both when available.

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Continuous multi-channel recording (ECG and Marker Channel telemetry or ECG and EGM, for example).

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Stimulation threshold test functions.

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Direct measurement of pulse rate, AV interval, and pulse width.

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Temporary implantable device inhibition.

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Printout of programmed and measured information for permanent record.

Programmer Reference Guide

Chapter 1

Programmer functions

Software update function:

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Automatic update and installation of application software via a dial-up or network connection to the Medtronic Software Distribution Network.

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Updates are available from the Software Distribution Network on a 24 hour/7 day per week basis.

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Software updates continue to be available on CD-ROM from Medtronic or Vitatron personnel.

Programmer Reference Guide

System components

Figure 1-1. Programmer components - front view

Introduction to the Programmer

System components

1Display screen

2 Emergency VVI

button

3 Microphone jack

4 Headphone jack

5 Keyboard cover

6 Keyboard

7 Printer controls

8 Telephone cord

(not supplied)

9 Printer paper

10 Programming

head

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

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’s 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.

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.

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.

Programmer Reference Guide

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 – Connect the ECG cable to the programmer. This connector has a black or blue marker.

Figure 1-3. Left view

1 ON/OFF switch

2Cooling fan

3 Expansion slot

4Printer

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 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

1 Disk drive, PC card cover

2 Infrared window

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

Chapter 1

System components

Figure 1-5. Disk drive, PC card cover open (two variations of programmer hardware are shown)

1 2

1PC card slot

2 Parallel connector

3 Disk drive

1PC card slot

2 USB port

3 Disk drive

4 Integrated Ethernet

PC card slot – There are different types of PC cards that can be

plugged into the PC card slot:

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The Modem card.

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The Combination Ethernet/Modem Network card, referred to as the combo card.

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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 or CD-ROM drive to be connected to the programmer.

Disk drive – Accommodates a 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).

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)

1 USB port(s)

2 VGA output port

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.

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

Chapter 1

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. The Select Model screen below 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

1Task bar

2 Status bar

3 Live Rhythm Monitor window

4 Task area

Programmer Reference Guide

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.

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 90 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

Chapter 1

Display screen features

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:

■

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

The present pacing mode.

Test condition status.

The device model.

[Adjust...].

After model selection, Marker Channel and telemetered EGM waveform traces may be available.

Refer to the appropriate reference guide for the implanted device for more information about the Live Rhythm Monitor. Refer to the

2290 Analyzer

on the Waveform Adjustment bar.

Programmer Reference Guide

Reference Guide for information about the controls

1 Waveform Adjustment bar

Introduction to the Programmer

Display screen features

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.

Command bar

The bar at the bottom of the screen shows the command buttons for automatically launching the proper software application and displaying the Vitatron Select Model screen. For information on what command buttons are available after selecting a model, see the reference guide for the implanted device.

Buttons

Buttons like those shown below let you operate the programmer using the touch pen. You can “press” a button by touching it with the tip of the touch pen.

1 Inactive button (indicated by a lighter color)

Buttons may directly execute a command, such as

[Freeze], or

they may open a window that prompts another action. Usually such buttons have a label ending with an ellipsis, such as

[Strips...] or [Adjust...] which are shown above.

A procedure may instruct you to “press and hold” a button. Press the tip of the touch pen to the button and maintain pressure until it is time to “release” the button.

When a button is inactive, it appears a lighter color and does not execute a command when you press it with the touch pen.

Programmer Reference Guide

Chapter 1

Display screen features

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. For more information see “About the between sessions tool palette” on page 80. For information about the session tool palette refer to the reference guide for the implanted device.

Programmer Reference Guide

Setting up the programmer2

Basic setup 32

Connecting peripheral devices 38

Chapter 2

Basic setup

Before setting up the programmer, select a sturdy location for it without blocking the air vents on the right and left sides. The programmer uses a power cord, so the location must be near an AC outlet.

This section describes:

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Positioning the display

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Connecting the ECG cable

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Connecting the programming head

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Connecting the power cord

■

Connecting the telephone line

■

Connecting the Ethernet cable

■

Turning on the programmer

Programmer Reference Guide

Positioning the display

Setting up the programmer

Basic setup

1. Press inward on the two buttons on each end of the handle.

2. Lift up the display

3. Place it at a comfortable viewing angle.

Connecting the ECG cable

1. Slide the keyboard cover all the way back. Press the latch and flip up the keyboard.

2. Line up the arrow on the ECG cable with the red dot on the ECG connector.

3. Plug the cable into the connector with the black or blue marker on the right.

4. Flip down the keyboard, making sure the cable passes through the notch on the right or left side.

Programmer Reference Guide

Chapter 2

Basic setup

Note: The Medtronic Model 2090 EC/ECL ECG cable is designed for use with five lead wires. However, some physicians prefer to use only four lead wires. If four lead wires are used, insert the chest ECG plug into the middle cable port of the ECG cable.

Device description

The ECG cable and lead wires connect five skin electrodes to the programmer.

Intended use

The ECG cable and lead wires connect the programmer to skin electrodes for ECG and measurement functions requiring surface detection of cardiac and implantable device signals.

Warnings and precautions

Device integrity – Upon opening the package, if the ECG cable

appears damaged, do not use it. Contact your local Medtronic or Vitatron representative.

Connecting the ECG cable – Improper insertion of the cable plug may damage the connector pins.

Disconnecting the ECG cable – Do not pull on the insulated cable wire to disconnect the cable. Tension on the insulated cable wire may result in damage to the cable.

Storage temperatures – Do not expose the ECG cable to storage temperatures above 70 °C (158 °F) or below -40 °C (-40 °F).

Maintenance and cleaning information

See page 98 for cleaning instructions.

Programmer Reference Guide

Connecting the programming head

Connecting the power cord

Setting up the programmer

Basic setup

1. Slide the keyboard cover all the way back. Press the latch and flip up the keyboard.

2. Line up the red dots on the programming head cable and the programming head connector.

3. Plug the cable into the programming head connector with the yellow marker on the left.

4. Flip down the keyboard, making sure the cable passes through the notch on the right or left side.

1. Open the back cover by pressing on both latches.

2. Plug the power cord into the programmer.

3. Plug the power cord into AC power outlet. The programmer automatically adjusts to the available line power.

4. Make sure the power cord passes through the notch on the left side and close the cover.

Programmer Reference Guide

Chapter 2

Basic setup

Connecting the telephone line

1. Locate the disk drive/PC card

cover on the right side of the programmer and flip down the cover.

2. Connect the telephone line to

the RJ-11 connector on the modem card or combo card. (The combo card is shown.)

3. Connect the opposite end of the

telephone line to an analog telephone jack.

4. If you replaced the card, you will

need to reboot the programmer before using it.

Connecting the Ethernet cable (as applicable to your hardware)

1. Locate the disk drive/PC card

cover on the right side of the programmer and flip down the cover.

2. Connect the Ethernet cable to the

Integrated Ethernet connection.

3. Alternatively, the Ethernet cable

can be connected to the RJ-45 connector on the combo card instead of using the integrated Ethernet connection, or if the integrated Ethernet connection is not available.

4. Connect the opposite end of the

Ethernet cable to a network jack.

Programmer Reference Guide

Turning on the programmer

Note: The programmer will not operate without the appropriate software installed. Should the programmer not operate, check the version of software that is loaded on the programmer, and update it if necessary. See the topic “Checking the software version” on page 85, for more detailed instructions.

Setting up the programmer

Basic setup

1. Locate the ON/OFF switch on the left side of the programmer.

2. Press inward on the top of the ON/OFF switch.

Note: The first time the programmer is turned on following one of these changes, the start-up will take two minutes:

■

When a new keyboard language is installed

■

When the keyboard is removed (the programmer has been previously turned ON with a keyboard)

■

When a keyboard has been added (the programmer has been previously turned ON without a keyboard)

■

When the PC card has been removed (the programmer has been previously turned ON with a PC card)

■

When a PC card has been added (the programmer has been previously turned ON without a PC card)

Programmer Reference Guide

Chapter 2

Connecting peripheral devices

An analog input/output connector under the keyboard 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. Contact your Medtronic or Vitatron 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

All electronic devices that are connected to the programmer must meet the electrical safety requirements of IEC-60950.

Locating the peripheral device connector

Programmer Reference Guide

1 Analog Input/Output connector with green marker (under

the keyboard)

Updating programmer software using

the Software Distribution Network

The Software Distribution Network 40

Connecting to the SDN using a dial-up connection 40

Connecting to the SDN using a wired network connection 47

Connecting to the SDN using a wireless network connection 50

Obtaining technical manuals 52

Chapter 3

The Software Distribution Network

Programmer software can be updated by Medtronic customers or Medtronic personnel by accessing the Medtronic Software Distribution Network (SDN) and downloading the software. The SDN uses a world-wide private network to connect to servers in the United States. These servers are able to download software to many programmers simultaneously though secure connections.

The SDN is available 24 hours per day, 7 days per week and always contains the most current software. For this reason it is recommended that you download the software from the SDN rather than from the CD-ROM or flash drive.

You can connect to the SDN using a network connection (wired or wireless) or a dial-up connection. It is recommended that you use a network connection whenever possible, since software downloads are significantly faster using a network connection than using a dial-up connection.

Note: It is recommended that the SDN be checked on a regular basis. This will reduce the size of the download and the time it takes to receive the software.

Note: If the download was interrupted, the download will resume the next time the programmer attempts to access the SDN.

Note: Do not perform software updates using the SDN during an electrosurgical procedure.

Connecting to the SDN using a dial-up connection

You can connect to the SDN using the programmer’s combo card or modem card, and a connection to an analog phone line. In most cases the modem connection to the SDN can be made using a local telephone number. There is an 800 number provided, however, it should only be used if a local number is not available.

Before you begin, make sure that the telephone line is correctly connected to the combo or modem card see “Connecting the telephone line” on page 36.

Programmer Reference Guide

Updating programmer software using the Software Distribution Network

Connecting to the SDN using a dial-up connection

How to connect to the SDN using dial-up

1. Tap the Programmer icon.

Note: The SDN cannot be accessed from Vitatron screens. Change to the Medtronic Select Model screen.

2. Select Software from the

menu. The programmer displays the

Software on This Programmer screen and lists the software already installed on the programmer. For each model, the screen displays the software version.

3. Select [Install from

Medtronic...].

4. Press [Accept] if you agree to

the terms of the installation agreement. The download will begin.

Press [Cancel] if you do not agree to the terms. The download process will be cancelled and the programmer will redisplay the Software on This Programmer screen.

(Continued)

Programmer Reference Guide

Chapter 3

Connecting to the SDN using a dial-up connection

5. If the programmer has the combo card installed, the Scheduled Software Update window appears showing the LAN connection by default.

Press [Configure] to choose Dial-up Connection.

Then, select the radio button next to Dial-up Connection.

The Scheduled Software Update window redisplays, now showing Dial-up Connection. Press [Start] to continue.

6. If the programmer has the modem card installed, the programmer automatically displays the Update Software screen.

7. Review the Update Software screen.

To select a different clinic location, click on the down arrow.

If your clinic location is not listed, refer to “Editing Locations” on page 43 for instructions on how to edit, create, or remove a location.

8. Enter a dialing prefix, if one is needed.

9. Click [Start] to begin the software download.

10. While the programmer is connecting to Medtronic, the screen will temporarily go blank.

(Continued)

Programmer Reference Guide

Updating programmer software using the Software Distribution Network

Connecting to the SDN using a dial-up connection

11. The programmer reboots, dials the SDN and then displays a list of software that will be downloaded and installed.

Note: Individual software cannot be selected or rejected.

You may press [Stop] at anytime and resume the download at a future time.

When the download is complete, the programmer disconnects from the SDN. Then it automatically reboots and displays a screen listing the software that was downloaded.

12. To obtain technical manuals for the new software see Obtaining technical manuals 52.

13. Click the Select Model icon. The programmer is then

available for patient use.

14. The first time the newly downloaded software is accessed, some additional installation steps may be completed but these are automatic and no user intervention is required.

Editing Locations

Part of the dial-up software download process involves confirming the programmer location on the Update Software screen. If the clinic location does not appear in the clinic location pull-down menu or if information about an existing location needs to be changed, choose the <Edit Locations> selection from the pull-down menu.

Programmer Reference Guide

Chapter 3

Connecting to the SDN using a dial-up connection

The following procedures describe how to create a new location, make changes to an existing location, or remove a location from the programmer.

To create, edit or remove a location, you must be on the Update Software screen. Note that the Update Software screen appears as one of a series of screens that are accessible only during the software update process.

Programmer Reference Guide

Updating programmer software using the Software Distribution Network

How to create a new location

Connecting to the SDN using a dial-up connection

1. Using the clinic pull-down menu, select Edit Locations. When the Edit Locations screen appears, click on [New].

2. When the new dialog window opens enter the name of the location.

3. Using the pull-down menus, identify the location by selecting the Country, Region, and Nearest City.

4. Using the pull-down menu for Number to dial, select the number that will be dialed to access the SDN.

5. In the Dialing Prefix field, enter the digits of a dialing prefix, if a prefix is required to access an outside line.

6. To set this location as the default location on the Update Software screen, click on Set as default location.

7. Click on [OK] to save this location information.

8. When the Update Software screen is redisplayed, select the clinic and click on [Start] to begin the download process or click on [Cancel] to exit from the download operation.

Programmer Reference Guide

Chapter 3

Connecting to the SDN using a dial-up connection

How to change location information

1. On the Edit Location screen use

the pull-down menu to select an existing location. Then, beginning with the Nearest City, use the pull-down menu to select a different city if it needs to be changed.

2. To select a different SDN

access number, use the pull-down menu opposite the Number to dial field. The list of SDN access numbers shown is based on the Nearest City selected.

3. In the Dialing Prefix field, enter

the digits of a dialing prefix, if a prefix is required to access an outside line.

4. To set the currently displayed

location as the default location on the Update Software screen, click on Set as default location.

5. Click on [OK] to save this

location information.

6. When the Update Software

screen is redisplayed, select the clinic and click on [Start] to begin the download process or click on [Cancel] to exit from the download operation.

Removing a location

Programmer Reference Guide

1. On the Edit Location screen use the pull-down menu to select the name of the clinic you wish to remove from the programmer.

2. Click on [Remove].

3. Click on [Yes] to confirm the deletion.

4. On the Edit Location screen, select the clinic to be used from the pull-down menu, then click on [OK].

5. When the Update Software screen is redisplayed, click on [Start] to begin the download process or click on [Cancel] to exit from the download operation.

Updating programmer software using the Software Distribution Network

Connecting to the SDN using a wired network connection

You can connect to the SDN using the combo card or Integrated Ethernet, and your clinic’s network. By connecting through your network, software download time can be significantly reduced.

Before you begin, make sure the Ethernet cable is correctly connected to the combo card or Integrated Ethernet (see “Connecting the Ethernet cable (as applicable to your hardware)” on page 36).

Programmer Reference Guide

Chapter 3

Connecting to the SDN using a wired network connection

How to connect to the SDN using a network connection

1. Tap the Programmer icon. Note: The SDN cannot be

accessed from Vitatron screens. Change to the Medtronic Select Model screen.

2. Select Software from the menu.

The programmer displays the Software on This Programmer screen and lists the software already installed on the programmer. For each model, the screen displays the software version.

3. Select [Install from Medtronic...].

Press [Accept] if you agree to the terms of the installation agreement. The download will begin.

or Press [Cancel] if you do not

agree to the terms. The download process will be cancelled and the programmer will redisplay the Software on This Programmer screen.

(Continued)

Programmer Reference Guide

Updating programmer software using the Software Distribution Network

Connecting to the SDN using a wired network connection

4. The programmer displays the Scheduled Software Update screen.

Either choose to start the download at a particular time by selecting a time from the Scheduled Update Time pull-down menu, or begin the download as soon as possible by pressing [Start].

5. The Scheduled Software Update window displays a countdown window showing how much time remains until the countdown begins. Press [Start Now] to override the countdown or press [Cancel] to interrupt the countdown and the download request and return to the Software on This Programmer screen.

6. The programmer displays a list of software that will be downloaded and installed.

Note: Individual software cannot be selected or rejected.

You may press [Stop] at anytime and resume the download at a future time.

7. When the download is complete, the programmer disconnects from the SDN, automatically reboots, and displays a screen listing the software that was downloaded.

8. To obtain technical manuals for the new software, see “Obtaining technical manuals” on page 52.

9. Click on the Select Model icon. The programmer is then available for patient use.

Note: The first time the newly downloaded software is accessed, some additional installation steps may be completed but these are automatic and no user intervention is required.

Programmer Reference Guide

Chapter 3

Connecting to the SDN using a wireless network connection

You can connect to the SDN using your clinic’s wireless network.

Before you begin, make sure the wireless connection is correctly configured see “Configuring the SessionSync wireless network connection” on page 92.

How to connect to the SDN using a wireless network connection

1. Tap the Programmer icon. Note: The SDN cannot be

accessed from Vitatron screens. Change to the Medtronic Select Model screen.

2. Select Software from the menu.

The programmer displays the Software on This Programmer screen and lists the software already installed on the programmer. For each model, the screen displays the software version.

3. Select [Install from Medtronic...].Press [Accept] if you agree to the terms of the installation agreement. The download will begin.

Press [Cancel] if you do not agree to the terms. The download process will be cancelled and the programmer will redisplay the Software on This Programmer screen.

(Continued)

Programmer Reference Guide

Updating programmer software using the Software Distribution Network

Connecting to the SDN using a wireless network connection

4. The programmer displays the Scheduled Software Update screen.

Either choose to start the download at a particular time by selecting a time from the pull-down menu, or begin the download as soon as possible by pressing [Start].

6. The programmer displays a list of software that will be downloaded and installed.

Note: Individual software cannot be selected or rejected.

You may press [Stop] at anytime and resume the download at a future time.

7. When the download is complete, the programmer disconnects from the SDN, automatically reboots, and displays a screen listing the software that was downloaded.

8. To obtain technical manuals for the new software see “Obtaining technical manuals” on page 52.

9. Click on the Select Model icon. The programmer is then available for patient use.

Note: The first time the newly downloaded software is accessed, some additional installation steps may be completed but these are automatic and no user intervention is required.

Programmer Reference Guide

Chapter 3

Obtaining technical manuals

Medtronic technical manuals, including the one you are reading, are available in a number of different formats from the Medtronic eManuals website at www.medtronic.com/manuals. The website offers real-time access to the latest version of manuals 24 hours per day, seven days per week. Manuals can be viewed online, downloaded and then viewed or printed on a local printer, or ordered from the website.

All manuals are available online in English. Most manuals are also available in additional languages in online, CD-ROM, or a paper format. New manuals are added to this site regularly. If you do not find the manual you want, please contact your Medtronic representative.

Medtronic will ship your order for CD-ROMs or printed versions of manuals from our facility within 24 hours. Your order should reach you within three business days. If you need a copy before the shipment arrives, download the manual and print it, or contact your Medtronic representative.

Accessing the eManuals website

1. Point your browser to the following URL: www.medtronic.com/manuals

2. Those accessing the website from the United States will just need to click on [OK]. Anyone outside of the US will need to indicate they are outside of the US and select a language preference.

3. To see lists of CRDM manuals, click on the desired category on the left of the screen. You can also search for manuals using a product name or model number.

Programmer Reference Guide

Conducting a patient session4

Preparing for a patient session 54

Initiating a patient session 64

Ending a patient session 68

Storing components 68

Chapter 4

Preparing for a patient session

Familiarize yourself with the following information before beginning a patient session:

■

Connecting the programmer to skin electrodes

■

Using the touch pen

■

Using the keyboard

■

Positioning the programming head

■

Emergency VVI button

Connecting the programmer to skin electrodes

At the start of each patient session, ECG cable leads must be connected to the patient to detect cardiac and pulse artifact signals.

Note: The quality of disposable skin electrodes used with the programmer is important to the performance of the programmer signal sensing functions. Chemical reactions occur at the electrode/paste interface and produce small DC voltages that can block the ECG signal. Using high quality silver/silver chloride (Ag/AgCl) electrodes can minimize this problem. Electrodes should be fresh and from the same box. The patient’s skin should be prepared according to the directions provided with the electrodes.

Protocols covering attachment of leads to disposable skin electrodes may vary. Leads may be attached to the electrodes either before or after the electrodes are applied to the patient. The order of the procedure given below is arbitrary.

Programmer Reference Guide

Warning: Do not connect the programmer to wires or electrodes internal to the body. The programmer is designed to be medically safe only when attached to surface electrodes.

Attaching electrodes

Conducting a patient session

Preparing for a patient session

1. Attach five standard, disposable electrodes to the patient in the positions shown.

Programmer Reference Guide

Chapter 4

Preparing for a patient session

Connecting the ECG cable

1. As shown, attach a color-coded lead wire to each of the five electrodes. Match a color to each electrode as in Ta bl e 4 -1 .

R N C F L

Note: Connecting the chest lead is

optional. If the chest lead is not used, insert the chest ECG plug into the middle cable port of the ECG cable.

RA RL V LL LA

Tab le 4- 1. Electrode lead wire color coding

AHA Coding

Black Yellow to left arm

Red Green to left leg

Brown White to left chest area

Green Black to right leg

2. Connect each lead wire to the ECG cable as in Table 4-2. Match each lead connector to the proper cable port.

IEC Coding

Body Area

White Red to right arm

chest ECG plug into the middle cable port of the ECG cable.

Tab le 4- 2. ECG cable color coding

AHA Coding IEC Coding

Black to LA Yellow to L

Red to LL Green to F

Brown to V

Green to RL Black to N

White to RA Red to R

Programmer Reference Guide

American Hospital Association

International Electrotechnical Commission

Connecting the chest lead is optional. If the chest lead is not used, insert the

Labeled C on some cables

White to C

Note: Occasionally, mutual interference occurs between the programmer skin electrode signals and signals from an external ECG recorder or monitor attached directly to the patient. This interference may cause erratic operation of the programmer functions that depend on surface signal detection. If interference occurs, the leads from the attached ECG recorder or monitor should be temporarily disconnected. This interference does not affect the programming functions of the programmer.

Using the touch pen

The touch pen is used to select programming functions provided by the software. Proper use of the pen is described below in Figure 4-1 and in “Selecting an option on the screen” on page 58.

Figure 4-1. Using the touch pen

Conducting a patient session

Preparing for a patient session

Programmer Reference Guide

Chapter 4

Preparing for a patient session

Selecting an option on the screen

1. Move the tip of the pen to a position directly over the desired option

While positioning the pen, do not press it against the screen. Hold the pen perpendicular to the screen. The pen tip should be close to the screen.

If the desired option is a displayed key or “button”, position the pen tip within the rectangular outline.

If the desired option is a name or number, such as a parameter or parameter value, position the pen directly over the letters or numbers forming the option

2. Touch the pen to the screen to select an option.

Programmer Reference Guide

Using the keyboard

Conducting a patient session

Preparing for a patient session

Certain fields on the screen allow you to enter data, such as the patient’s name or chart number. The programmer has a compact computer keyboard for entering data.

Figure 4-2. Programmer keyboard

Positioning the programming head

At some point during most applications of the programmer, the programming head must be positioned over the implantable device. Positioning the programming head is required for any interaction between the programmer and the implantable device.

When to position the programming head

Caution: Do not position the programming head over an

implanted device during electrocautery or external defibrillation procedures.

During a patient session, properly position the programming head over the implanted device before any of the following actions:

■

Selection of any command that initiates a programming transmission. The programming head must be held in position until completion of the transmission, which is usually indicated by a confirmation message.

Programmer Reference Guide

Chapter 4

Preparing for a patient session

■

For any temporarily programmed state or function or for reception of continuous data such as Marker Channel telemetry or EGM waveforms, the programming head must be held in place over the implantable device for the duration of the function or until termination is desired. Lifting the programming head cancels a temporary program and terminates continuous telemetry. The implantable device reverts to permanently programmed values.

Determining the correct position

For an implantable device, the programming head should be held directly against the patient’s skin. The face of the programming head must be parallel to and typically within 2 inches of the implantable device. Optimum position of the programming head may not be directly centered over the implantable device.

Selection of any command that initiates data transmission from the implantable device. The programming head should be held steady until data reception is complete, which is usually indicated by a confirmation message.

Selection of a measurement function that requires the implantable device to be operating asynchronously as a result of the programming head magnet.

Figure 4-3. Positioning the programming head

Correct placement of the programming head is indicated in two places: the position head array in the top left corner of the screen and the array of seven lights on the programming head (see Figure 4-3).

Programmer Reference Guide

Light Array

Green

Amber/Green

Conducting a patient session

Preparing for a patient session

Programming and Interrogation are not recommended when less than two green lights are on.

Programming and interrogating the implanted device

1. Select the appropriate software parameters according to the reference guide.

2. Position the programming head near the implantable device.

Programming and Interrogation can begin when the position head array turns green.

Note: For Medtronic devices, the position head array shows the signal strength of the communication link. Moving the programming head to maximize the number of green lights is recommended. All lights may not illuminate for all models (see the reference guide for the implanted device).

Note: Vitatron and Reveal Plus devices may turn one light in the position head array to green when the programming head is in the correct position rather than indicating the signal strength.

Note: Misalignment of the programming head could result in failure of a programming transmission and/or failure to receive data from the implantable device.

Using the P and I buttons

The P button and I button on the programming head (Figure 4-4) correspond to commands that appear on the display screen of the programmer. Refer to the appropriate reference manual to determine which commands the buttons correspond to. For convenience, you may press the P button or the I button on the programming head in place of selecting the corresponding option from the display.

Programmer Reference Guide

Chapter 4

Preparing for a patient session

Figure 4-4. P and I buttons

The programming head magnet

A strong magnet in the programming head actuates a sensor in the implantable device, which makes the implantable device receptive to programming (refer to the reference guide for the implanted device for more information about the effects of a magnet).

Be aware that the programming head may attract metal instruments or be attracted to metal surfaces. The magnet is susceptible to partial demagnetization when it is subjected to opposing magnetic fields - that is, forcing the programming head against another magnet.

P Button

I Button

The programming head should be kept away from any device or material that will be damaged by the magnetic field, including computer diskettes. The programming head should be stored as shown in Figure 4-6 on page 69 when not in use.

Emergency VVI button

The red Emergency VVI button on the display panel provides immediate access for emergency VVI pacing (Figure 4-5). (Specific parameter values are determined by each application.)

■

Programmer Reference Guide

For all Medtronic pacemaker applications, the Emergency VVI button is active when the [Emergency] button is displayed on screen.

For some ICD applications, the Emergency VVI button is active at all times. When pressed, this button delivers VVI pacing and displays the emergency screen options.

Conducting a patient session

Preparing for a patient session

Note: The Emergency VVI button is also implemented in the software and appears on the display. It functions similarly to the button on the panel.

Warning: The red Emergency VVI button is disabled for the following devices: PCD, Jewel PCD, Micro Jewel II, MicroJewel, Jewel CD, Jewel Plus, Model 7202 Jewel CD, Models 7218 and 7211, Model 7201 CD, and Jewel AF. Use the touch pen to select the on screen [Emergency] button.

Delivering emergency bradycardia pacing

To initiate emergency pacing, correctly position the programming head over the implanted device and press the red Emergency VVI button. A message confirms programming, and emergency VVI operation begins.

Delivering emergency tachyarrhythmia therapy:

To deliver therapy, press the red Emergency VVI button to display the emergency screen on the programmer and select the on-screen [Deliver] button with the touch pen.

For specific applications, refer to the appropriate device Reference Guide, System Reference Guide, or Clinician Manual for complete instructions regarding the use of the Delivery button

Figure 4-5. Emergency button

VVI

Emergency VVI

Button (Red)

Programmer Reference Guide

Chapter 4

Initiating a patient session

A patient session involves the application of the various programmer functions to such procedures as programming implantable device parameters, analyzing or assessing implantable device operation, troubleshooting, and routine follow-up. The instructions for using each programmer function are covered in the reference guide for the implanted device.

Note: Before proceeding, ensure that all preparations covered in Chapter 2, “Setting up the programmer” on page 31 and “Preparing for a patient session” on page 54 have been completed.

Programmer checklist

1. Is the programmer set up according to the procedures in

2. Are the ECG cable, touch pen, and programming head connected

3. Does the power cord connect the programmer to an AC power

4. Has the appropriate software been installed? Refer to Chapter 6

5. Are the programmer ECG cable leads connected to electrodes on

Specific information related to each implantable device model or family of models is included in the reference guide for the device.

Chapter 2?

to the programmer?

outlet?

for a description of how to verify the software version and refer to Chapter 3 to update software, if necessary.

the patient as described in “Connecting the programmer to skin electrodes” on page 54?

Refer to the reference guide for the implanted device before beginning a patient session.

Model identification

Because the programmer collects and stores data on a session-by-session basis, it is important to correctly start and end each session.

Programmer Reference Guide

Conducting a patient session

Initiating a patient session

The programmer supports both a Medtronic and Vitatron desktop. Whichever desktop is in use when the programmer is powered down, that same desktop will appear when the programmer is powered on. To switch from the Vitatron desktop to the Medtronic desktop and vice versa, select the Vitatron/Medtronic switch button that appears on the bottom of the screen.

There are two ways to begin a patient session:

■

Prior to turning on the programmer, position the programming head over the patient’s device. When you turn on the programmer, the programmer will attempt to interrogate the device. Depending on the device, either the software application will be launched automatically or a message will appear with further instructions.

■

After turning on the programmer, position the programming head over the patient’s device. During the first five minutes, the Medtronic desktop will display the Find Patient screen. Afterward, it displays the Select Model screen. The Vitatron desktop displays the Select Model screen immediately. A patient session can begin at either the Find Patient screen or the Select Model screen. Follow the instructions that follow, based on the screen that is displayed.

Find Patient screen

When the programmer is first turned on, the Medtronic desktop displays the Find Patient screen. After about five minutes, the Find Patient screen is replaced by the Select Model screen.

When the Find Patient screen is displayed you may begin a patient session.

Programmer Reference Guide

Chapter 4

Initiating a patient session

Place programming head over the patient’s device and hold it steady. For most devices, the programmer will identify the device model and automatically start up the proper software application. If a device cannot be automatically identified, the programmer displays a message at the top of the Find Patient screen. The message will provide further instructions:

■

Select cancel and manually select the software application from the Select Model screen.

■

Select cancel and then select the Vitatron/Medtronic switch button to go to the Vitatron desktop, or

■

Indicate that the software application that is needed has not been installed. You will need to install the software before proceeding. Refer to Chapter 3 for software installation instructions.

Select Model screen

A patient session may also begin from the Select Model screen. The Select Model screen appears:

Programmer Reference Guide

■

Shortly after the programmer has been turned on.

■

After you end a patient session.

Conducting a patient session

Initiating a patient session

If the Select Model screen is not displayed, use the touch pen to select the Select Model icon. If the Select Model icon is not displayed, a patient session is in progress. You must end that session before starting a new one.

If you are between patient sessions, you can access other screens by using the icons and buttons described in Chapter 6.

If the device is a Vitatron device and it is not listed on the Select Model screen, refer to the Vitatron Software Programming Guide.

If the Select Model screen does not look like this example and you see a button, select the Vitatron/Medtronic switch button to display this screen.

Position the programming head over the patient’s device and hold it steady. Select [Find Patient] shown on the Medtronic desktop or manually select the device from the displayed list of devices and select [Start].

When a device is manually selected from the list of devices, the programmer starts up the application that corresponds to your selection, not the device that is under the programming head. The Find Patient screen quickly displays as the programmer starts up the proper software application.

Programmer Reference Guide

Chapter 4

Ending a patient session

If the software application has not been installed, the programmer displays a message and you will need to install the software before proceeding. Refer to Chapter 3 for software installation instructions.

Note: If your device does not support concurrency, you must exit the Analyzer before you can start a device session. That is, if you use the task bar to switch from the Analyzer to the Select Model screen and then select [Find Patient], the programmer will display the following message:

This application is not able to run concurrently with the Analyzer. Please exit the Analyzer and try again.

The programmer may automatically interrogate the patient’s implanted device to retrieve most of the data that might be needed during the session. To take advantage of this automatic interrogation, you must position the programming head over the implanted device and continue to hold it in place until the interrogation is complete.

Refer to the reference guide for the implanted device for more information about determining the model.

Ending a patient session

When you want to end a patient session there are three options. You may save data to a disk, save to SessionSync, or end the session without saving.

Please refer to the reference guide for the implanted device for specific information on saving device data.

Storing components

The following diagrams show the proper way to store components (Figure 4-6).

Programmer Reference Guide

Figure 4-6. Storing components

Conducting a patient session

Storing components

Programmer Reference Guide

Using external printers 72

Installing printer paper 76

Printer buttons 77

Tearing off a printout 78

Low paper supply 78

Using printers5

Chapter 5

Using external printers

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.

All printers listed by this software are certified to IEC 60950, UL 60950 or equivalent. Only printers listed by this software may be connected to the programmer. It is the responsibility of the user to keep the printer at least two meters away from the patient.

Printer compatibility

The programmer is compatible with many printers. A list of compatible printers can be accessed from the Print Queue screen.

Note: When programming a Vitatron device, refer to the applicable Vitatron reference guide for information about the print queue.

To view a list of supported printers

Some devices only support the internal programmer printer and the print queue window shown below cannot be displayed. Refer to the applicable device reference guide.

For those devices that support an external printer, refer to the following procedure.

Programmer Reference Guide

1. If you are conducting a patient session, select

Reports then Print Queue.

If you are not conducting a patient session, select the Print Queue icon.

2. On the Print Queue screen, select the

Printer field to open the list of supported printers.

Materials you will need

To connect a printer to the 2090 programmer, you will need a USB printer cable or a Parallel Interface printer cable. For a USB printer cable, one end must be a USB Type A connector. The other end of the cable must fit the USB port on your printer. For a Parallel Interface printer, 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.

Connecting the printer

Prior to connecting a printer to your 2090 programmer, you should exit the patient session and turn the programmer off.

Using printers

Using external printers

Programmer Reference Guide

Chapter 5

Using external printers

To connect the printer to your 2090 programmer (method you use depends on your programmer hardware)

The following steps apply to programmers with hardware that supports both parallel and USB printing.

1. To connect a printer, locate the correct port.

■

For USB cable printers, use a USB port located in the power cord compartment of the programmer.

■

For Parallel Interface printers, the Parallel Interface port is located under the disk drive/PC card 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 USB port or parallel connector on the programmer.

3. Connect the other end of the cable to the printer. Connect the printer power cord to an outlet and turn the printer on. Make sure that the printer has paper.

Note: Refer to the technical information provided with your printer for information about connecting and operating the printer.

4. 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.

Programmer Reference Guide

Using printers

Using external printers

The following steps apply to programmers with hardware that supports USB printing only.

1. To connect a printer, locate the correct port. There is one USB port located under the disk drive/PC card cover and two ports located under the power cord door on the back of the programmer.

2. Connect the printer cable to a USB port on the side or back of the programmer.

3. Connect the other end of the cable to the printer. Connect the printer power cord to an outlet and turn the printer on. Make sure that the printer has paper.

Note: Refer to the technical information provided with your printer for information about connecting and operating the printer.

4. 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.

Programmer Reference Guide

Chapter 5

Installing printer paper

How to load printer paper

The internal printer requires a special thermal paper supplied in flat packs. You may obtain this paper directly from Medtronic or Vitatron. One package of printer paper contains six individual packs of paper. Each pack contains approximately 200 perforated sheets.

1. Press the latch on the top of the tray on the left side of the programmer. Slide the tray out. Flip the paper holder over the end of the tray and remove any remaining paper.

Note: The tray may be taken out of the programmer to make removing any remaining paper easier. Press down on the lever on the side of the tray towards the front of the programmer.

2. Remove the wrapping from a new flat pack of printer paper, dispose of the cardboard and unfold the top sheet.

Note: The shiny side of each sheet of paper with two black squares should be facing up as the paper is loaded into the tray. The black squares must be positioned toward the front of the programmer

3. Slide the paper pack toward the back of the tray. Flip the paper holder over the paper pack.

4. Fold the top sheet of paper over the paper holder. Slide the tray back into position.

Programmer Reference Guide

Printer buttons

Using printers

Printer buttons

The four buttons shown below control certain printer functions.

Figure 5-1. Printer buttons

1 50 mm/s

2 25 mm/s

3 12.5 mm/s

4 Paper Advance

50, 25, or 12.5 mm/s. – Three buttons allow for selection of a desired paper speed for ECG, Marker Channel telemetry, and EGM recording. Pressing a button selects the printer speed and turns on the indicator light. Pressing a lit button stops the printout. The selected paper speed is printed once along the top edge of the chart recording. Paper speed for text printing is not affected by these buttons.

Paper Advance – Pressing Paper Advance advances the printer paper to its next perforation for tearing off.

Programmer Reference Guide

Chapter 5

Tearing off a printout

When you wish to tear off a printout, separate the paper strip at a perforation. To tear the printout off at the printer, press Paper Advance. This action advances the paper to the next perforation. Grasp the printout an inch or two from the printer and pull.

Figure 5-2. Tearing off printouts

Low paper supply

As the paper supply nears its end, a red stripe will appear along the edge of the paper. At this point, a new paper pack should be installed as previously described in this chapter. When the paper supply runs out, the printer stops operating.

Note: The thermal paper used in this programmer is intended for immediate use. As the quality of thermal paper diminishes over time, the image fades. Medtronic and Vitatron recommend that you make photocopies for your files.

Programmer Reference Guide

Setting desktop preferences6

About the between sessions tool palette 80

Adjusting programmer time and date 82

Selecting audible tones 83

Changing the language setting 84

Improving the detection of pacing artifacts 84

Checking the software version 85

Starting the demonstrations option 86

Viewing and updating programmer location and hardware information 86

Selecting other software 88

Chapter 6

About the between sessions tool palette

The between sessions tool palette is on the Select Model screen.The Select Model screen appears before you select a model, when you turn the programmer on, and when you end a patient session.

The tools that are available between sessions are described in Ta bl e 6 - 1.

Note: When programming a Vitatron device, refer to the applicable reference guide for information about the tool palette.

Programmer Reference Guide

Setting desktop preferences

About the between sessions tool palette

Tabl e 6 -1 . Between Patient Sessions tool palette

Tool palette Tool Selecting the tool (button or icon)…

Freezes a segment of the live rhythm display. Note: A frozen strip can be viewed and printed (but not

saved) between patient sessions. Markers and EGM traces are not present between patient sessions.

Accesses the rhythm strips saved during a patient session. Note: No saved strips are available between patient sessions.

Opens a window of options for adjusting the live rhythm display.

Note: Additional adjustment options are present during a patient session.

Displays the screen for selecting a model and starting a patient session.

Displays a queue of print requests from previous sessions as well as frozen waveform reports requested between sessions. Refer to the reference guide for the implanted device to determine if these features are available.

Displays the programmer setup options.

Preferences Time and Date Artifact Detection Software Demonstrations Programmer Profile Other Software

Selects the Analyzer for analyzing the electrical performance of a cardiac lead system (requires optional hardware - see the 2290 Analyzer Reference Guide.)

Note: When some functions are active on the display, selecting a tool button or icon will have no effect. Closing the active window restores operation of the tool palette.

Programmer Reference Guide

Chapter 6

Adjusting programmer time and date

If the time or date displayed and printed by the programmer is incorrect, use the following procedure to enter the correct settings. For Vitatron devices, see the applicable reference guide.

Setting the time and date

1. Select Programmer then Time and Date.

2. From the Programmer Time and Date screen, select the or button to increase or decrease the value for the unit of time you want to change. Press and release the button for single unit changes or press and hold the button to effect greater changes.

3. When all fields show the correct time and date, press [Apply]. Select another tool palette icon to close the Programmer Time and Date window.

Programmer Reference Guide

Note: Time must be entered on the basis of a 24-hour clock, with 00:00 being midnight and 12:00 being noon.

Selecting audible tones

Certain events in the operation of the programmer result in an audible signal. The following tones alert the user to the success or failure of an action.

■

A two-tone beep (low-to-high) indicates confirmation of an Interrogate or a Program command.

■

A double low-tone beep indicates that an Interrogate, Program, or Emergency command was not confirmed. It can also indicate that the selected command cannot be executed.

Note: For some devices, the tones may not be turned off. See the reference guide for the implanted device. For Vitatron devices, see the applicable reference guide.

Turning tones on or off

Setting desktop preferences

Selecting audible tones

1. Select Programmer then Preferences.

2. From the Preferences screen, select [Audio ON] or [Audio OFF] as desired.

Programmer Reference Guide

Chapter 6

Changing the language setting

The software is translated into several languages. Use the following procedure to determine which languages are available. For Vitatron devices, see the applicable reference guide.

Choosing a language

1. Select Programmer then Preferences.

2. From the Preferences screen, select the Language field to display the options.

Improving the detection of pacing artifacts

The Artifact Detection function allows one to improve the detection of pacing artifacts when interference causes either false artifacts or no artifacts to appear on the patient’s ECG. Pacing artifacts are displayed on the patient’s ECG when the artifact detection option (Show Artifacts) has been enabled.

See the reference guide for the implanted device to determine if this feature is applicable.

Enabling artifact detection

1. Select Programmer then Artifact Detection.

2. Select the filter on option.

For information on using the Artifact Detection function, see the reference guide for the implanted device.

Programmer Reference Guide

Checking the software version

This section describes how to determine the version of software that is loaded on the programmer.

If you need to know what version of software is currently loaded on the programmer for any of the device models, use the following procedure.

For Vitatron devices, see the applicable reference guide.

To check the software version number

Setting desktop preferences

Checking the software version

1. Select Programmer then Software.

2. For each device model with software loaded on the programmer, the screen displays the software version number next to the model number.

Note: If the model that interests you is not displayed, the software to support that model is not currently loaded on the programmer. Refer to “The Software Distribution Network” on page 40 for instructions.

Programmer Reference Guide

Chapter 6

Starting the demonstrations option

The demonstrations option allows you to run a demonstration program on the programmer. Refer to the demonstration instructions that accompany the program diskette for specific operating procedures.

For Vitatron devices, see the applicable reference guide.

Accessing demonstrations

1. Select Programmer then Demonstrations.

2. Insert the demonstration diskette into the disk drive.

3. From the Demonstration Model Selection screen, select the desired View option to list the available demonstration programs.

4. Select the desired demonstration program and press [Start] followed by [Continue].

Viewing and updating programmer location and hardware information

Information about the location of the programmer and its hardware is on the Programmer Profile screens.

The Programmer Profile location screen has the following information:

■

Clinic’s name, address, phone number, contact person, and customer account number

■

Service representative’s name, phone number, fax number, and E-mail address

The Programmer Profile hardware screen has the model number for the Analyzer, and model and serial numbers for the programmer and the programming head.

Information on the screen may be updated by selecting the appropriate field and then using the keyboard.

Programmer Reference Guide

Viewing and updating programmer location and hardware information

Accessing Programmer Profile screens

1. Select Programmer then Programmer Profile. Location information appears by default.

2. To view hardware information, select Hardware Information.

Verifying Programmer Profile information

Each programmer has a profile screen that contains identifying information about the installed hardware, the programmer’s location and contact information for the Medtronic or Vitatron service representative.

Typically, the profile is completed when the programmer is first installed and then updated only when necessary. Although it is not required to check the profile prior to each software download, it is a good practice to periodically verify that the information on the Programmer Profile screen is complete and accurate before connecting to the SDN.

Setting desktop preferences

1. Tap the Programmer icon and then select Programmer Profile.

2. Complete the location information or verify that the information shown is correct.

Programmer Reference Guide

Chapter 6

Selecting other software

In addition to the standard application software, there are some programmers that have special applications installed. These special applications are considered research software and are used in conjunction with clinical studies. If you have this research software installed, you may access the software, using the following procedure.

1. Select Programmer then Other Software.

2. When the programmer displays the list of available software, select the application and press Start.

Programmer Reference Guide

SessionSync 90

Optional Software Features7

Chapter 7

SessionSync

SessionSync is an optionally installed feature that provides network connectivity between the 2090 programmer and the Medtronic Paceart data management system. Using your clinic’s network, the programmer can send downloaded device data through SessionSync to the data management system.

The SessionSync status icon and the SessionSync status screen provide information on the connection status of the programmer to the data management system.

You must configure the programmer’s network settings to allow for this data transfer.

This section describes:

■

Configuring the SessionSync network connection

■

Configuring the SessionSync wireless network connection

■

Enabling and disabling SessionSync

■

Viewing SessionSync Status

■

States of the SessionSync Status icon

Programmer Reference Guide

Optional Software Features

Configuring the SessionSync wired network connection

See “Connecting the Ethernet cable (as applicable to your hardware)” on page 36 for instructions on connecting the programmer to the network.

1. Select Programmer > SessionSync Network Configuration...

2. Enter the Clinic Name.

3. Enter the IP address or hostname of the SessionSync Gateway.

Note: If you do not have your SessionSync Gateway address, contact your clinic’s technical support or Medtronic Paceart technical support at 1-800-PACEART.

4. Select [OK].

SessionSync

Programmer Reference Guide

Chapter 7

SessionSync

Configuring the SessionSync wireless network connection

Make sure your Wireless card is properly installed before you begin. Medtronic strongly recommends using the WPA-PSK wireless protocol, as shown in the Network Authentication field.

1. Select Programmer >

SessionSync Network Configuration...

2. Enter the Clinic Name.

3. Enter the IP address or

hostname of the SessionSync Gateway.

Note: If you do not have your SessionSync Gateway address, contact your clinic’s technical support or Medtronic Paceart technical support at 1-800-PACEART.

4. Enter the Network Name.

Enter and confirm your Network Key. Note: If you do not know your Network Name or Network Key, contact your clinic’s technical support.

5. Select [OK].

Programmer Reference Guide

Enabling and disabling SessionSync

Viewing SessionSync Status

Optional Software Features

SessionSync

1. Select Programmer > Preferences.

2. Select SessionSync from the Index menu.

3. Select [Enabled] to enable SessionSync or Select [Disabled] to disable SessionSync.

Note: The SessionSync icon will be grayed out when the feature is disabled. SessionSync functions are not available within a patient session unless you have enabled this feature prior to starting a patient session.

The SessionSync Status screen displays information on the data files being transferred to the data management system using SessionSync. Each message includes the date, time, and event information for the associated SessionSync event.

Note: SessionSync data transfer may be delayed during an electrosurgical procedure.

Programmer Reference Guide

Chapter 7

SessionSync

How to view SessionSync status

Note: SessionSync status does not dynamically update when the

window is open. To update select the [Update Status] button.

1. Select Programmer >

SessionSync Status.

2. Select [Update Status].

SessionSync Status icon

The SessionSync status icon provides information on the network connection between the 2090 programmer and the data management system.

Figure 7-1. The task bar with the SessionSync Status icon

1 The SessionSync Status icon

If SessionSync is not installed on the programmer, the icon will not be visible in the task bar.

Programmer Reference Guide

Figure 7-2. Parts of the SessionSync Status icon

Optional Software Features

SessionSync

1 The programmer status

2 The connection status between the programmer and the data management system

3 The data management system status

The sections of the SessionSync Status icon will change colors to indicate data ready for transfer, a valid connection between the programmer and the data management system, and successful data transfer to the data management system.

Note: When the whole icon is grayed out, SessionSync has been disabled under the programmer preferences.

Tabl e 7 -1 . SessionSync Status icon states

Part of SessionSync Status Icon

Programmer Gray No session data files are in

Color What the color indicates

the Transfer Queue. The transfer queue is the list of session data files that have been saved to the programmer’s hard disk but are waiting for transfer.

Blue Session data files exist in the

Connection Not

visible

Green Valid connection exists

Red circle with a line through it

Transfer Queue

No valid connection exists between the programmer and the data management system

between the programmer and the data management system

Device application in use does not support SessionSync

Programmer Reference Guide

Chapter 7

SessionSync

Tab le 7- 1. SessionSync Status icon states

Part of SessionSync Status Icon

Data Management System Gray No session data has been

Color What the color indicates

transferred to the data management system

Blue All session data has been

successfully transferred to the data management system

Programmer Reference Guide

Servicing the Programmer8

Cleaning the system components 98

Sterilizing the programming head, ECG cable, and lead wires 98

Replacing a PC card 99

Programmer specifications 100

Special notice 104

Medtronic limited warranty 105

Chapter 8

Cleaning the system components

The exterior surfaces of the programmer and its accessories may be cleaned with a damp sponge or soft cloth moistened with water, mild detergent, or alcohol. Care must be taken to prevent liquid from entering the programmer and programming head.

Do not immerse the programmer or any accessories in any liquid or clean them with aromatic or chlorinated hydrocarbons.

With the exception of the programming head and ECG leads and cable, the programmer and its accessories cannot be sterilized.

Sterilizing the programming head, ECG cable, and lead wires

Caution: Do not autoclave the programming head or ECG

cable and lead wires.

Ethylene-oxide

Note: The programming head or ECG cable and lead wires must

be completely dry before being ethylene-oxide sterilized.

Biological indicators should be used to ensure that proper sterilization standards have been met. A previously validated sterilization cycle should be used.

Due to the variability in sterilization systems, precise sterilization instructions cannot be provided. Contact the manufacturer of your sterilization system for more information regarding procedures.

Programmer Reference Guide

1. Wrap the programming head or ECG cable and lead wires in packaging permeable to ethylene oxide.

2. Medtronic recommends that exposure to ethylene oxide is not to exceed 3 hours and is followed by a minimum of 12 hours of aeration.

3. Do not exceed 55

°C (131 °F).

Servicing the Programmer

Replacing a PC card

Gas plasma (programming head only STERRAD 100S gas plasma system)

1. Place the programming head in packing material appropriate for gas plasma sterilization.

2. Sterilize by procedures validated for effectiveness using suitable biological controls.

a. Do not exceed 55 °C (131 °F). b. Do not use an H c. Do not expose the programming head to a sterilizer cycle longer

than 72 minutes.

d. Do not resterilize more than five programming heads in one load

or combine them with other surgical instruments or devices in the same load.

Visually inspect the cable and connections of the programming head after sterilizing. Do not use the programming head if it appears damaged. Damage includes, but is not limited to deterioration of the cable insulation (brittleness, cracking, thinning, or bare spots). Do not use the programming head if the conductive wires are exposed.

concentration below 1 mg/L.

2O2

Replacing a PC card

Contact your Medtronic or Vitatron representative if you need to replace a PC card in the programmer.

Note: It is not necessary to perform a safety check when a PC card is inserted or replaced in the programmer.

Procedure for replacing a PC card

1. Turn off the programmer.

2. Open the disk drive/PC card cover. See Figure 1-5 for the location.

3. Remove the existing PC card.

4. Insert the new PC card. If you are installing the wireless card, insert it into the top slot.

5. Turn on the programmer.

Programmer Reference Guide

100

Chapter 8

Programmer specifications

Tab le 8- 1. 2090 Programmer specifications

Standards (The programmer complies with the following:)

EMC Patient Safety

Voltage

Frequency Power

Resolution

Paper Type Waveform Recording

Speeds

Input Impedance at DC ECG Range of

Linear Operation ECG Total Signal Error Pacing Pulse Width

EN 60601-1-2 UL/CUL 60601-1, Class I, Type BF ordinary

EN 60601-1, Class I, Type BF, continuous operation

Power requirement

100 to 125 VAC nominal or 200 to 240 VAC nominal

50/60 Hz nominal 400 watts

Printer

600 dots/25 mm horizontally for waveform traces at print speeds through 25 mm/sec., 400 dots/25 mm at 50 mm/sec.; 200 dots/25 mm vertically

110 mm wide, Thermal, Medtronic No. 6092

12.5, 25 or 50 mm/s

ECG specifications

>2.5 Me

- 5 mV to + 5 mV

< 10% > 100 µs to 2 ms

Ω at 10 Hz

Height

Width Depth Weight

Operating Storage

Programmer Reference Guide

Physical dimension and weight

12.7 cm (5 in) screen down, 48.2 cm (19 in) screen up

40.6 cm (16 in)

55.8 cm (22 in)

11.3 kg (25 lbs), including modem

Temperature limits

9.4 °C to 35 °C (48.9 °F to 95 °F)

- 22 °C to 60 °C (- 7.6 °F to 140 °F)

Medtronic 2090 Programming Guide

Specifications and Main Features

Frequently Asked Questions

User Manual

Contents

1 Introduction to the Programmer 11

2 Setting up the programmer 31

4 Conducting a patient session 53

5 Using printers 71

6 Setting desktop preferences 79

7 Optional Software Features 89

8 Servicing the Programmer 97

Introduction to the Programmer1

Setting up the programmer2

Conducting a patient session4

Using printers5

Setting desktop preferences6

Optional Software Features7

Servicing the Programmer8