Medtronic 2290 Reference Guide

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MEDTRONIC CARELINK® 2290

Analyzer for Medtronic and Vitatron Devices

Analyzer Reference Manual

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

2290 Analyzer 0

Reference Guide 0

A guide for setting up and using the 2290 Analyzer.

The following list includes trademarks or registered trademarks of Medtronic in the United States and possibly in other countries. All other trademarks are the property of their respective owners.

Jewel, Marker Channel, Medtronic, Medtronic CareLink, Reveal, and Vitatron.

Explanation of symbols 7

About this guide 9

1 Analyzer quick reference 11

Typical values 12

Performing a lead analysis 13

2 Overview 15

Device description 16

Intended use 17

Contraindications 18

Warnings and precautions 18

3 Detailed device description 23

Analyzer overview 24

Changing the pacing mode 34

Pacing parameters 37

Emergency VVI pacing 41

Analog output of Analyzer signals 43

Non-programmable features 44

4 Conducting a basic Analyzer session 47

Preparing the Analyzer for use 48

Analyzing the lead 53

Printing reports 58

Ending the analyzer session 60

5 Using the concurrency feature 63

What is concurrency? 64

Concurrency Task Bar controls 66

How to tell if your device supports concurrency 67

When you can switch sessions using the task bar 67

Setting up for an implant 68

Pacing therapy 69

Printing with concurrency 71

Analyzer Reference Guide

Contents

Exporting lead measurements from the analyzer session to the device session 72

6 Using advanced features 79

Conduction tests 80

Pulse width/amplitude threshold test 82

Rapid atrial stimulation 84

7 Maintenance 87

Installing the Analyzer 88

Replacing the backup battery 89

Cleaning the Analyzer 90

Functional test, maintenance and safety checks 91

Service 93

Disposal of Analyzer 93

Special notice 93

Medtronic limited warranty 94

8 Analyzer specifications 95

Standards 96

Storage and operating environment 96

Measurement parameters 96

Pacing parameters 97

9 V backup battery 98

9 Accessories 99

Analyzer Reference Guide

Device description 100

Intended use 100

Warnings and precautions 101

Maintenance 102

Instructions for use 103

Special notice 105

Medtronic disclaimer of warranty 105

Index 107

Explanation of symbols

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

Explanation of symbols

Conformité Européenne (European Conformity). This symbol means that the device fully complies with European Directive AIMD 90/385/EEC and R&TTE 1999/5/EC.

For US audiences only

Serial number

Temperature limitation

Caution

Consult instructions for use

Type CF Applied Part

Reorder number

Lot number

Humidity limitation

Open here

Package contents

Cable

Product documentation

Positioning of cell

Analyzer Reference Guide

EC REP

Chapter

Explanation of symbols

Battery check

9V Battery

Accessories

On/Off

Direct current

The product complies with both Canadian and U.S. requirements for meeting UL safety standards.

Date of manufacture

Manufacturer/Date of manufacture

Authorized representative in the European Community

Analyzer Reference Guide

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.

About this guide

This guide provides information about the use and maintenance of the Medtronic 2290 Analyzer (referred to as the Analyzer).

This manual assumes that you are familiar with the use of the Medtronic 2090 programmer. For specific information about using the ECG or display, refer to the 2090 Programmer Reference Guide.

Hereinafter, all occurrences of the word “programmer” refer to the Medtronic 2090 series programmer.

About this guide

Analyzer Reference Guide

Analyzer quick reference1

Typical values 12

Performing a lead analysis 13

Chapter 1

Typical values

The following table shows typical measurements for implanted, non-steroid-eluting leads.

Table 1-1. Typical measurements

Test Atrium Ventricle

P/R waves > 2 mV > 5 mV

Slew rate > 0.5 V/s > 0.75 V/s

Impedance 300 – 800 Ω

Threshold – acute < 1.5 V < 1 V

Threshold – chronic 2 – 3 times the Acute values

Current < 4.5 mA < 3 mA

Use of high impedance leads can result in measurements greater than 800 Ω.

Analyzer Reference Guide

Analyzer quick reference

■

P-wave

■

R-wave

■

slew rate

Performing a lead analysis

Setup Page

Necessary equipment:

■

Medtronic 2090 programmer with the Analyzer, Medtronic Model 2290

■

ECG cable with leads and skin electrodes (see 2090 manual)

■

Medtronic Model 2292 Analyzer surgical cable, or Medtronic Model 5436 Analyzer patient cable, or Medtronic Model 5103 Analyzer adaptor and compatible cable(s), or Medtronic Model 5104 Analyzer adaptor and compatible cable(s)

2. Set up and turn on the 2090 programmer. page 48

3. Connect the patient to the programmer ECG input (see 2090 manual).

4. Select the Analyzer icon. page 48

Connections

1. Set the polarity (only applies when using the Model 5436 patient cable). page 51

2. Connect the surgical cable, patient cable, or adaptor and compatible cable(s) to the Analyzer.

3. The clinician connects the implanted lead to the cable. page 52

Lead analysis

1. Note the automatic beat-to-beat sensing values: page 53

page 17

page 52

2. Turn pacing ON for the lead that is to be analyzed, or select the desired Mode.

■

Adjust Lower Rate and Amplitude to ensure pacing.

page 34

3. Note the automatic Impedance measurement on the first pacing pulse. page 54

4. Select [Threshold...].

■

Determine the Amplitude Threshold.

page 55

5. Note the pacing current value automatically measured at threshold. page 55

6. Test for diaphragmatic stimulation using the [10 Volt Press and Hold] button. page 55

7. Save the threshold value. page 55

8. Save and print the measurement values for the lead(s). page 56

page 57

9. End the session. page 60

-1

Emergency pacing (VVI, 70 min

■

Select the [Emergency] button on the display screen.

(ppm), 10 V, 1.5 ms, 2.5 mV)

page 41

■

Press the red Emergency VVI hard key on the programmer.

Analyzer Reference Guide

page 41

Device description 16

Intended use 17

Contraindications 18

Warnings and precautions 18

Overview2

Chapter 2

Device description

The Analyzer is a microprocessor-based accessory that installs into the programmer (see Figure 2-1). The Analyzer is designed to analyze the electrical performance of a cardiac lead system, and uses the programmer as a control and display platform.

The Analyzer can be operated "concurrently" with the Programmer desktop. That is, you can switch to an analyzer session from the Select Model screen on the Programmer desktop, and you can toggle back and forth between an analyzer session and the Select Model screen using icons on the task bar.

Figure 2-1. The Analyzer installed in the programmer

Analyzer Reference Guide

1 Analyzer

Key features

Safety features

Intended use

The Analyzer has the following key features:

■

Automatic measurement of P- and R-wave amplitudes and slew rates

■

Automatic lead impedance measurement

■

Real-time display of atrial and ventricular EGM

■

Rapid atrial stimulation to 800 min-1 (ppm)

■

Advanced analysis features, including antegrade and retrograde conduction tests, and a pulse width versus amplitude threshold analysis

■

Measurement reports

The Analyzer has the following safety features:

■

Backup battery in the event of a power loss

■

Electrical isolation from the programmer

■

Emergency VVI pacing

Overview

Package contents

Intended use

■

one 2290 Analyzer

■

one Model 2292 Analyzer surgical cable

■

one 9 V battery

■

one screwdriver, if the Analyzer is supplied separately from the programmer.

■

Product literature

The Analyzer is intended for use by a clinician to analyze the pacing and sensing performance of the cardiac lead system during the implant of a cardiac arrhythmia management device, or during invasive troubleshooting of a cardiac lead system.

Analyzer Reference Guide

Chapter 2

Contraindications

There are no known contraindications to the use of a lead analysis device. The patient's age and medical condition, however, may dictate the pacing modes and lead analyses appropriate for the patient.

Warnings and precautions

Equipment modification – Do not modify this equipment.

Modifications may reduce device effectiveness and impact patient health.

Line-powered equipment – During lead implantation and testing, use only battery-powered equipment or line-powered equipment specifically designed for this purpose, to protect against fibrillation that may be caused by alternating currents. Line-powered equipment used in the vicinity of the patient must be properly grounded. Lead connector pins must be insulated from any leakage currents that may arise from line-powered equipment. An implanted lead forms a direct current path to the myocardium.

Analyzer Reference Guide

Electrosurgical units (cautery) – Do not use electrosurgical units within 15 cm (6 inches) of the cardiac lead system. Electrosurgical units can cause tachyarrhythmias by inducing current on the leads.

Rapid atrial stimulation – Be sure to have defibrillation equipment readily available during rapid atrial stimulation. Use of high rates in the atrium can result in high-rate conduction to the ventricle. Accidental high-rate stimulation of the ventricles may result in ventricular tachycardia or fibrillation.

Single complex monitor – Connect the patient to a separate ECG monitor in order to view a continuous ECG, if the single complex monitor is selected on the Analyzer. The single complex monitor replaces the continuous waveform monitor on the display screen, thereby eliminating indication of complete heart activity.

Overview

Warnings and precautions

Handling inserted leads – Do not touch the exposed metal of the connector end of the leads or the exposed metal of the cable clips when handling inserted leads. Do not allow the exposed metal of the connector end of the leads or the exposed metal of the cable clips to unintentionally contact electrically conductive or wet surfaces.

Connecting the cardiac lead system – Connect all surgical cables, patient cables and adaptors to the Analyzer before connecting the lead(s) to the surgical cable or patient cable.

DDD or VDD pacing mode – Do not operate the Analyzer in the DDD or VDD pacing mode when only the ventricular pacing lead is connected. Interference detected at the unconnected atrial input of the Analyzer can result in false sensing and can drive the ventricular pacing rate to the Upper Rate setting.

Threshold tests – Carefully consider the patient's medical condition before performing a threshold test. The following may occur during a threshold test.

■

Asystole may result due to loss of capture.

■

Pacing stimuli may be inadvertently delivered within the vulnerable period of the T-wave. This may be hazardous to patients with acute myocardial infarction or who are otherwise predisposed to arrhythmias.

Electromagnetic interference (EMI) – Avoid excessive levels of EMI, if possible. At high sensitivity settings and in the presence of excessive levels of interference, the Analyzer may inhibit completely or revert to asynchronous pacing operation, pacing at the Lower Rate. Sources of excessively strong EMI that can temporarily affect the operation of the Analyzer include the following equipment.

■

Electrosurgical equipment

■

Diathermy equipment

■

Some medical telemetry equipment, when operated within one meter (about three feet) of the Analyzer

■

Communication transmitters such as cellular phones and “walkie talkies”

Analyzer Reference Guide

Chapter 2

Warnings and precautions

Electromagnetic compatibility – Electrically-operated medical devices, such as the Medtronic Carelink 2090 with the Analyzer programming system, require special care (in terms of EMC) when being installed. Refer to the insert, Electromagnetic Compatibility Declaration, which is provided with the 2090 Programmer.

Changing polarity settings – Confirm the polarity capabilities of the cardiac lead system before changing polarity settings. Changing polarity settings could result in loss of pacing if the cardiac lead system is not set up to facilitate pacing in the polarity selected.

Temporary pacing – Do not use the Analyzer to provide external pacing in situations where the patient is left unattended. The Analyzer is a diagnostic device.

Prolonged power loss – Connect the patient to an external temporary pacemaker in the event of a prolonged power loss (more than five minutes).

High output and maximum sensitivity – The simultaneous use of high output (high amplitude and wide pulse width) and maximum sensitivity should be avoided. The combination of high output and maximum sensitivity may result in over-sensing intrinsic events, far-field sensing of intrinsic events, or sensing of paced events. The effects of the combination of high output and maximum sensitivity may include the following:

■

In the presence of large ventricular depolarization potentials or high output, use of high atrial sensitivity (low numerical settings) may allow ventricular potentials to inappropriately inhibit or trigger the atrial output.

■

High output and maximum sensitivity may result in opposite-chamber sensing of the pace output. Unipolar setting may be more likely to have over-sensing in the presence of high output and maximum sensitivity. The Analyzer contains a safety pacing feature to prevent inappropriate inhibition of ventricular pacing due to far-field sensing.

■

Use of high sensitivity in the ventricle may result in inappropriate inhibition of the ventricular output due to T-wave or myopotential sensing.

Analyzer Reference Guide

Overview

Warnings and precautions

Electrostatic discharge (ESD) – Discharge any static electricity from your person before touching the patient, the cable, the leads, or the Analyzer. The pacing lead(s) provides a low-impedance pathway to the heart.

Termination of pacing – Set the Analyzer to a demand mode (a mode that senses in the chamber in which it is pacing) before terminating pacing.Then gradually reduce the pacing rate below the patient’s intrinsic rate. Once a spontaneous rhythm is established, the Analyzer may be exited. Abrupt termination of pacing stimuli may result in intervals of asystole before an intrinsic rhythm is reestablished.

Backup battery – Do not replace the backup battery while the Analyzer is connected to the patient. When the Analyzer is removed from the programmer, the connector port on the backside of the Analyzer could provide a low-resistance path to the myocardium for ESD. Also, the backup battery connects to the circuitry which connects directly to the patient. The battery connector could, therefore, provide a low-resistance path to the myocardium for ESD or leakage currents.

If the Analyzer will be out of service for an extended period of time, remove backup battery to prevent any potential for battery leakage.

Defibrillation/cardioversion – Whenever possible, for the safety of the patient, disconnect the Analyzer from the lead cardiac system before defibrillating or cardioverting.

Also the Analyzer may be damaged by defibrillatory discharges when it is connected to an indwelling cardiac lead system.

■

The Analyzer recovers normal operation within two seconds in the ventricle and within six seconds in the atrium for the defibrillation test pulse defined in IEC 60601-2-31.

■

The Analyzer should be tested after being exposed to such charges.

Environmental precautions – Take precautions to avoid damage to the device, including (but not limited to) the examples in the following list. The Analyzer has been carefully designed and tested to ensure reliability during normal use. However, electronic devices are susceptible to many environmental stresses.

Analyzer Reference Guide

Chapter 2

Warnings and precautions

■

Do not drop the device or handle it in a way that might physically damage the device. The device may appear to work appropriately immediately after being dropped or mishandled, but operational damage may have occurred.

■

Avoid spilling fluid on the device. Even though the device was carefully designed to minimize leakage, fluid incursion may occur.

■

Discharge any charge collected on your body before touching the device. This device could be adversely affected by electrostatic discharge.

■

Remove battery when the Analyzer is stored for extended intervals.

■

Do not open the device. The device is constructed to minimize risk from environmental factors. Opening the device may make the device susceptible to environmental factors.

■

Always allow the temperature of the device to stabilize in the environment in which the device will be used before using the device. Rapid temperature changes can affect proper operation.

■

Prolonged storage or operation of the device in high humidity may affect proper operation.

■

Return the device to Medtronic for inspection and any needed repair if there is any concern that damage has occurred (see the addresses on the back cover).

Analyzer Reference Guide

Other environmental factors may impact proper performance of the device in the hospital setting. Use appropriate environmental health and safety practices to help prevent environmental damage to the device.

Detailed device description3

Analyzer overview 24

Changing the pacing mode 34

Pacing parameters 37

Emergency VVI pacing 41

Analog output of Analyzer signals 43

Non-programmable features 44

Chapter 3

Analyzer overview

The display screen

This section provides information about the components of the display screen (Figure 3-1).

Figure 3-1. Display screen and emergency hard key

1 Task bar

2Status bar

3 Live Rhythm Monitor window

4 Live Rhythm Monitor controls

5Tool palette

6 Task area

7 Command bar

8 Emergency VVI hard key

Analyzer Reference Guide

Detailed device description

Analyzer overview

Task bar - The task bar contains these icons/indicators:

Tab le 3-1. Task bar icons/indicators

Icon Name Function

Position head light array

Analyzer indicator/selector

Device icon Used to go to the Select Model screen or,

SessionSync icon Provides information about the connection

Turns green to indicate that the programming head has been placed over the device.

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.

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.

and data transfer status between the 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.

USB indicator Turns green to indicate USB flash drive is

Diskette indicator Turns green to indicate diskette drive is

available for saving reports and patient data. When USB indicator is green, diskette is not available. When inserting a USB device, you may experience a slight delay before device is available for use.

available for saving reports and patient data. When diskette indicator is green, USB is not available.

Status bar

This area displays the pacing mode and any status messages.

Analyzer Reference Guide

Chapter 3

Analyzer overview

Live rhythm monitor window

This area displays the rate/rate interval and waveform traces (see “Live rhythm monitor” on page 27).

Live rhythm monitor controls

Selecting one of these buttons controls what appears in the live rhythm monitor window. See “Live rhythm monitor” on page 27 for more information. These controls are:

[Freeze] button. This button takes a snapshot of the current wave form (strip), displays it in a lower window, and allows you to print it and/or save it to disk.

[Strips...] button. Once you have used the [Freeze] button to save a strip to disk, the [Strips] button lets you retrieve the saved strip.

[Adjust...] button. This button displays the Adjust window, which contains options that let you change the waveform display.

Emergency VVI hard key

Analyzer Reference Guide

The emergency hard key is the red button on the monitor hardware to the left of the display panel. This key overrides all other functions and provides immediate pacing at preset emergency settings. See “Emergency VVI pacing” on page 41.

Command bar

The Command bar includes:

The [Emergency] button, which overrides all other functions and provides immediate pacing at preset emergency settings. See “Emergency VVI pacing” on page 41 for more information.

The [End Session] button, which ends the current Analyzer session. See “Ending the analyzer session” on page 60 for more information.

Task area

The task area displays different screens according to the task or function you select. All tests, measurements and menus are displayed in this area.

Tool palette

These icons provide the means to move between the various screens of the Analyzer. An icon is highlighted when its function is active.

Tab le 3-2. Tool palette icons

Live rhythm monitor

The Analyzer live rhythm monitor can display either continuous waveforms or single EGM (electrogram) complexes.

Continuous waveform monitor

When the Lead Analysis screen is displayed, the continuous waveform monitor displays continuous waveforms. Marker Channel annotations identifying paced and sensed events are provided to assist with the interpretation of the Analyzer’s operation.

Icon Name Function

Lead Analysis Displays the Lead Analysis screen (see

page 32).

Advanced Displays a menu for selecting advanced

Analyzer features (see page 79).

Detailed device description

Analyzer overview

Specific tests may temporarily reconfigure the number or type of waveforms displayed. However, once the test is over, the display returns to the configuration in effect before selecting the test.

Analyzer Reference Guide

Chapter 3

Analyzer overview

How to manipulate continuous waveforms

1. Select the continuous waveform button (selected by default).

2. Use the waveform adjustment buttons to change the size and order of the waveforms, and to specify which two will be printed.

3. Select [Adjust] to display the Adjust window to make more precise waveform adjustments.

Analyzer Reference Guide

Detailed device description

Analyzer overview

The Adjust window

Options available for adjusting the waveform traces using the Adjust window are as follows:

Tab le 3-3. Adjust window functions

Name Function

Clipping Select this checkbox to truncate the tops and

bottoms of waveform traces at the default setting. A check mark indicates that the filter option is turned on.

ECG Filter Select this checkbox to turn the ECG filter on or off.

A checkmark indicates that the filter is turned on. The filter may improve the clarity of the ECG in the presence of interference.

Show Artifacts Select this checkbox to enable or disable the pacing

Sweep Speed This field lets you select a sweep speed for your

Normalize Select this button to equalize the trace spacing and

Calibrate Select this button to add a reference signal to the

artifact enhancement function. When this function is selected, line boundaries appear showing the beginning and end of each wave.

wave forms of 12.5, 25, 50, or 100 mm/sec.

adjust the size of each trace to the default setting.

trace of Marker Channel, ECG, and EGM telemetry. The Marker Channel signal shows the relative marker amplitudes; the EGM calibration signal acts as a voltage reference for the displayed EGM.

Analyzer Reference Guide

Chapter 3

Analyzer overview

Waveform adjustment buttons

A waveform adjustment button bar has been added to each waveform for greater flexibility in selecting waveform options. To select a button for a waveform, touch it with the stylus.

Table 3-4. Waveform adjustment buttons

Name Function

Increase size. Touch and release to increase the size of the waveform.

Normalize. Touch to refresh the waveform trace and restore it to its original default size.

Decrease size. Touch and release to decrease the size of the waveform.

Waveform source. Touch to display a popup menu that lets you select the waveform source. Use this button to rearrange the order of the waveforms.

Waveform print selection. Touch to enable the waveform for printing. Up to two waveforms can be enabled.

Analyzer Reference Guide

Single complex monitor

Display a single EGM complex to more closely analyze sensing performance or intracardiac activity.

Caution: Only one complex from one chamber is visible at any one time in this view.

Note: At high rates, not all complexes are shown.

How to manipulate a single complex

Annotations above the waveform show:

■

rate/rate interval

■

chamber being displayed and filter state

■

peak-to-peak amplitude (when filtering and pacing are off).

Detailed device description

Analyzer overview

1. Select the single complex monitor button.

Note: The button is grayed if it does not function on a screen.

2. To change between atrial and ventricular EGM views, select either [A. EGM] or [V. EGM].

3. To see a filtered view of a single complex, select [Filter]. Note: The R-Wave filter that is currently selected is used for views of single complexes when [Filter] is selected.

The Sensitivity setting is shown when [Filter] is selected to provide a graphical representation of the sensing margin. See “A. Sensitivity or V. Sensitivity” on page 39 for more information.

Analyzer Reference Guide

Chapter 3

Analyzer overview

Lead Analysis screen

This section describes the components of the Lead Analysis screen (Figure 3-2).

Figure 3-2. Lead analysis screen

1 Pacing controls

2 Filter

3Mode

4 Lead measurements

Pacing controls

The fields in this area (Figure 3-2) determine pacing parameters as follows.

■

Lower Rate shows/adjusts the current lower pacing rate setting.

■

A. Amplitude/V. Amplitude shows/adjusts the atrial and ventricular pacing amplitudes.

■

Selecting [Settings...] opens the Analyzer Settings window (Figure 3-4 on page 38). From this window, you can select and adjust additional pacing parameters, such as pulse width, upper rate, sensitivity, and A-V interval.

See “Pacing parameters” on page 37 for more information.

Analyzer Reference Guide

Detailed device description

Analyzer overview

Mode

This field (Figure 3-2) shows the current pacing mode. See “Changing the pacing mode” on page 34 for more information.

Filter

This field (Figure 3-2) shows the current filter for R-Wave measurements. See “Changing the R-Wave Filter” on page 36 for more information.

Lead measurements

The fields in this area (Figure 3-2) display the measurements and threshold for the attached atrial and/or ventricular lead(s). For each lead, the Analyzer displays information about the following.

■

P-Wave amplitude (for the atrial lead)

■

R-Wave amplitude (for the ventricular lead)

■

Slew rate

■

Impedance

■

Stimulation threshold

Pace/sense LEDs

Note: When the New R-Wave filter is selected at the time of the

R-Wave measurement, a caret (^) is displayed in the Filter field and the R-Wave mV value.

Figure 3-3. Pace/sense LEDs

The Analyzer has four LEDs, which indicate the pacing or sensing activity in each of the chambers. The LEDs are located on the Analyzer module and are color-coded as follows.

■

A green LED indicates that a pacing pulse is being delivered.

■

An amber LED indicates that an event is sensed.

Analyzer Reference Guide

Chapter 3

Changing the pacing mode

LED operation during a power loss

The Analyzer will switch to the backup battery in the event of a power loss. The LEDs will continue to indicate the pacing and sensing operation of the device.

If, during a power loss, the Analyzer detects that the battery is low, the atrial and ventricular Sense LEDs will both flash synchronously with either Pace LED.

Changing the pacing mode

The pacing mode may be changed on the Lead Analysis screen in one of two ways:

■

Pacing fields

by selecting the Pacing fields.

by selecting the Mode field.

Selecting a Pacing field causes the field to toggle between ON and OFF. The NBG

codes that correspond to the possible ON/OFF

Pacing field combinations are listed in Table 3-5.

Table 3-5. Pacing field selectable modes

Atrium Ventricle Pacing Mode

OFF OFF ODO (Inhibited)

OFF ON VVI

ON OFF AAI

ON ON DDD

Note: If the Pacing fields are disabled, see “Mode field” on page 35.

“NBG” stands for the “North American Society of Pacing and Electrophysiology (NASPE) and the British Pacing and Electrophysiology Group (BPEG) Generic”

Analyzer Reference Guide

Detailed device description

Changing the pacing mode

How to change the pacing mode using the Pacing fields

1. Select the Pacing field under A. Lead to turn pacing ON or OFF in that channel.

2. Select the Pacing field under V. Lead to turn pacing ON or OFF in that channel.

3. The Analyzer starts or stops pacing immediately in the channel set to ON or OFF, respectively.

4. The mode is displayed in the Mode field.

Mode field

The Mode field allows you to select pacing modes that cannot be achieved through changing the Pacing fields.

Note: The Pacing fields are disabled if VOO, AOO, DOO, or VDD is selected. To re-enable the Pacing fields, select the ODO, VVI, AAI, or DDD pacing mode using the Mode field.

How to change the pacing mode using the Mode field

1. Select the Mode field.

2. Select a pacing mode from the list.

3. The Analyzer immediately begins pacing in that mode.

4. The mode is displayed in the Mode field.

Analyzer Reference Guide

Chapter 3

Changing the pacing mode

Mode transition rules

Filter field

Setting conflicts – If, as a result of changing pacing modes, any

settings conflict (e.g., the Lower Rate is set higher than the Upper Rate) or settings that would result in unexpected behavior (e.g., 2:1 block) occur, a warning message is displayed. Follow the directions on the message.

Defined values – During mode transitions, all applicable values (e.g., pulse width, output amplitude, sensitivity, rate, and AV interval) in effect in the previous pacing mode are carried over to the new pacing mode.

Previously undefined values – Values not defined by the previous pacing mode will be set to default values in the new pacing mode.

The Filter field displays the current R-Wave filter and is used to switch between the Original and the New R-Wave filter.

Note: The R-Wave filter can not be changed when a ventricular pacing mode is selected.

Changing the R-Wave Filter

The Filter field allows you to change the selected R-Wave filter. The R-Wave filter can only be changed during a Lead Analysis session by using the Filter field to switch between the Original and New R-Wave filters.

Cautions:

■

Select the correct filter for R-Wave amplitude measurements. If the correct filter is not selected for R-Wave amplitude measurements, the Analyzer may measure the R-Wave amplitudes greater than or less than the implanted device.

■

A ventricular sense may occur when the R-Wave filter is changed during an Analyzer session.

Analyzer Reference Guide

Detailed device description

How to change the R-Wave filter using the Filter field

1. Click the Filter field to switch between the Original or New for the R-Wave filter selection.

2. The selected R-Wave filter is displayed in the Filter field.

3. The Analyzer immediately begins measuring the R-Wave amplitude with the selected R-Wave filter.

Pacing parameters

Lead Analysis screen

Pacing parameters

Lower Rate and Atrial and Ventricular Output Amplitudes can be selected and adjusted on the Lead Analysis screen.

Lower Rate

The Lower Rate defines the lowest rate at which pacing occurs during a mode’s basic operation. The default value is

70 min

-1

(ppm).

Note: Lower Rate values above or equal to the Upper Rate are not

selectable when pacing in the VDD or DDD mode. Increase the Upper Rate to increase the range of selectable Lower Rate values.

Atrial Amplitude and Ventricular Amplitude

These parameters specify the voltage at which a pacing pulse will be delivered to the corresponding chamber of the heart. The

default value is 5 V.

Analyzer Reference Guide

Chapter 3

Pacing parameters

Analyzer Settings window

The Analyzer Settings window (Figure 3-4), which is accessed by selecting [Settings...], allows adjustment of the following parameters.

Figure 3-4. Analyzer Settings window

AV Interval

AV (Atrial-Ventricular) Interval determines the time between the occurrence of an atrial event and the scheduled ventricular pacing pulse. The default values are listed in Table 3-6.

AV Interval is automatically adjusted based on the selected Lower and Upper Rates (Table 3-6).

Table 3-6. Default AV interval

Pacing Mode Lower Rate

DOO 30 - 120 150

min

-1

(ppm)

Upper Rate

-1

min

(ppm)

AV Interval ms

Analyzer Reference Guide

130 - 180 75

190 - 220 50

DDD, VDD 80 - 120 150

130 - 180 75

190 - 220 50

Note: If AV Interval is manually adjusted, the automatic adjustments described above are discontinued.

Detailed device description

Pacing parameters

Upper Rate

The Upper Rate is the maximum rate at which the ventricle may be paced in response to sensed atrial events in the DDD and VDD modes. The default value is 120 min

-1

(ppm).

Values below or equal to the Lower Rate value are not selectable when pacing in the VDD or DDD mode. Decrease the Lower Rate to increase the range of selectable Upper Rate values.

A. Polarity or V. Polarity

These parameters specify the polarity that the Analyzer is expecting the lead(s) to be when the Model 5436 patient cable is used. The default value is Bipolar for both A. Polarity and V. Polarity. Polarity selection is only available when using the Model 5436 patient cable. The Analyzer treats the leads that are connected to all other cables and adaptors as bipolar. Therefore, use an indifferent electrode when connecting unipolar leads to the Analyzer using the Model 2292 cable, Model 5103 adaptor or Model 5104 adaptor.

A. Pulse Width or V. Pulse Width

These parameters specify the duration of the pacing pulse. The

default value is 0.5 ms.

A. Sensitivity or V. Sensitivity

The Sensitivity settings specify the minimum amplitude of electrical activity to which the device is responsive. The default

values are 0.5 mV for the atrium and 2.5 mV for the ventricle.

A. (Atrial) Refractory

Refractory is the period following a paced or sensed event during which a sensed event does not restart the timing for the next scheduled pacing pulse. Refractory senses do cause the sense LEDs to light.

This parameter allows adjustment to the length of the refractory period of the atrial channel following a ventricular or atrial sensed or paced event. The default values are listed in Table 3-7.

A. Refractory is automatically adjusted based on the selected Lower and Upper Rates (Table 3-7).

Analyzer Reference Guide

Chapter 3

Pacing parameters

Table 3-7. Default atrial refractory

Pacing Mode

Lower Rate

-1

min

(ppm)

Upper Rate

-1

min

(ppm)

ARP

PVARPb ms

AAI 30 - 120 400

130 - 180 275

190 - 220 200

DDD, VDD 80 - 120 300

130 - 180 225

190 - 220 200

Atrial Refractory Periods (ARP) occur in the atrial channel after an atrial event.

Post-Ventricular Atrial Refractory Periods (PVARP) occur in the atrial channel after a ventricular event.

Note: If A. Refractory is manually adjusted, the automatic adjustments described above are discontinued.

Analyzer Reference Guide

Emergency VVI pacing

The Emergency command is a safety feature that overrides all other functions and immediately paces the ventricle at preset emergency values.

Emergency pacing can be exited by setting the device to preset VVI values or by manually adjusting each pacing parameter.

Parameters

Mode VVI VVI Rate 70 min Ventricular amplitude 10 V 5 V Pulse width 1.5ms 0.5ms Ventricular sensitivity 2.5mV 2.5mV

Detailed device description

Emergency VVI pacing

Emergency pacing Nominal VVI Pacing

-1

(ppm) 70 min-1 (ppm)

Polarity remains at the setting

in effect before initiation of emergency operation

remains at the setting in effect before initiation of emergency operation

Considerations

Emergency values are settings that provide higher-than-normal energy output. It is not intended that the Analyzer be left at these settings indefinitely.

How to initiate Emergency pacing

A. Press the red Emergency VVI

hard key on the left side of the programmer display panel.

B. Select the on-screen

[Emergency] button in the lower left corner of the screen.

Analyzer Reference Guide

Chapter 3

Emergency VVI pacing

How to discontinue Emergency pacing

Details about Emergency pacing

When emergency pacing is initiated, the following events occur.

■

Any test in progress is ended.

■

A window opens describing the emergency values in effect.

■

“Emergency Pacing is ON” is displayed in the status bar. This message remains until the amplitude, pulse width, sensitivity, pacing mode, or lower rate are adjusted from emergency values.

■

All fields are updated to show the emergency values.

A. Select [Return to VVI

Nominals] from the Emergency Pacing window.

-Or-

1. Select [Close] to remain in

emergency pacing.

2. Adjust individual parameters by selecting the corresponding fields on the Lead Analysis screen.

Analyzer Reference Guide

If the red Emergency hard key is pressed while the Analyzer session is being entered, the status bar at the top of the display will show that the Analyzer is pacing in VVI mode, but the settings on the task area may not show the correct values. Press the Emergency hard key again to synchronize the displayed values with device operation.

If the programmer displays an error message, a message will be printed on the strip chart recorder indicating that the Emergency hard key is available.

If Lower Rate, V. Amplitude, V. Sensitivity, or the pacing mode is adjusted while in Emergency pacing, the message “Permanent V Pulse Width is 1.5 ms.” is displayed in the status bar to remind you that the ventricular pulse width is 1.5 ms.

Detailed device description

Atrial Pace (AP)

Atrial Sense (AS)

Atrial Refractory Sense (AR)

Vent. Refractory Sense (VR)

Vent. Sense (VS)

Vent. Pace (VP)

5 mV

1 mV

Analog output of Analyzer signals

The Analyzer uses the analog output port on the programmer to send up to four channels of simultaneous analog signals to hospital equipment such as physiological monitors, recorders, and plotters.

Parameters

Analyzer analog output channel assignments

Channel A Patient’s ECG Channel D Marker Channel

Channel B Atrial EGM Channel E None at this time

Channel C Ventricular EGM

The Marker Channel calibration signal shows the relative marker amplitudes, which are not annotated with character codes on an external device.

How to output analog signals

1. Connect the 2090AB analog input/output cable to the analog output port on the

programmer. For further instruction, see the 2090 Programmer Reference Guide.

2. Connect the 2090AB to the appropriate hospital equipment. For further instruction, see the manual for the Model 2090AB analog input/output cable.

3. Calibrate the hospital equipment. For further instruction, see the manual for the 2090AB analog input/output cable.

The EGM calibration signal acts as a voltage reference for the displayed EGM.

Analyzer Reference Guide

Chapter 3

Non-programmable features

Power loss and loss of host communication

Caution: In the event of prolonged power loss, move the

patient to an external temporary pacemaker. The backup battery has limited capacity and is intended to provide short term support, only (5 minutes or less).

In the case of a power loss, or if the Analyzer loses the ability to communicate with the programmer, the following events occur.

■

The Analyzer discontinues any test in progress and resumes the pre-test values.

■

The Analyzer increases atrial and ventricular pacing outputs to 5 V and atrial and ventricular pulse widths to 0.5 ms. If, before a power loss, the output values were set greater than 5 V and pulse width was set greater than 0.5 ms, the outputs will remain unchanged.

Note: Verify all parameter settings after power is restored.

■

If the Analyzer is providing pacing at the time of a power loss, it continues to operate by using the 9 V backup battery. Pacing support is provided for as long as a pacing load is detected.

■

Use the LEDs on the Analyzer to verify pacing and sensing operation.

Analyzer Reference Guide

The Analyzer shuts itself off immediately after a power loss if it is operating in ODO mode.

The Analyzer shuts itself off after sixty lower rate intervals when the following occur after a power loss.

■

The Analyzer does not detect a pacing load.

■

The Analyzer does not deliver an output over sixty consecutive lower rate intervals.

Note: If, during power loss, the Analyzer detects that the battery is low, the atrial and ventricular Sense LEDs will both flash synchronously with either Pace LED. However, the device will operate at the parameters in operation before detection of the low battery for a minimum of 5 minutes before shutting itself off.

See page 89 for information about replacing the backup battery.

Pacing operation description

Single chamber modes

In the single chamber asynchronous modes (AOO and VOO), the Analyzer paces at the Lower Rate, regardless of intrinsic activity.

In the single chamber demand modes (AAI and VVI), the Analyzer inhibits the next scheduled pacing pulse when an intrinsic event is sensed outside the refractory period and before the next scheduled pacing pulse. If no intrinsic event is sensed before the next scheduled pacing pulse, a pacing pulse is delivered.

Dual chamber modes

In the AV sequential asynchronous mode (DOO), the Analyzer paces the atrium at the selected Lower Rate and paces the ventricle at the selected or automatic AV Interval, regardless of any intrinsic activity.

In the VDD mode, the Analyzer responds to rate increases in the atrium, and paces only in the ventricle. The Analyzer inhibits the ventricular pacing pulse if an intrinsic ventricular event is sensed before the scheduled pacing pulse is delivered. An Upper Rate is set to prevent the ventricle from being paced too fast.

Detailed device description

Non-programmable features

In the DDD mode, the Analyzer responds to rate increases in the atrium, and provides AV sequential pacing. If no atrial or ventricular intrinsic events are sensed, the Analyzer paces the atrium at the selected Lower Rate and paces the ventricle at the selected or automatic AV Interval. Intrinsic activity in the atrium and ventricle inhibits the delivery of pacing pulses and restarts timers. An Upper Rate is set to prevent the ventricle from being paced too fast.

In the ODO mode, the Analyzer senses intrinsic activity in both the atrium and ventricle. The Analyzer does not deliver pacing pulses.

Analyzer Reference Guide

Chapter 3

Non-programmable features

Safety pacing

The device is designed to ensure that pacing of the ventricle is not inhibited in the presence of ambient noise or muscle artifact.

If, after an atrial paced event, a ventricular sensed event is detected within 110 ms, the Analyzer will deliver a ventricular output pulse at one of the following intervals.

■

The Analyzer will deliver a ventricular output pulse at the end of the set AV interval if it is set to less than 110 ms.

■

The Analyzer will deliver a ventricular output pulse at the end of 110 ms if the AV interval is set to 110 ms or more.

PVC response

A PVC (premature ventricular contraction) is defined as a ventricular paced or sensed event followed by a ventricular sensed event, without an intervening atrial event.

When a PVC is detected, the Analyzer restarts the VA interval, the ventricular refractory period, the upper rate timer, and restarts and extends PVARP to 400 ms, if PVARP is less than 400 ms.

Analyzer Reference Guide

If the PVC is preceded by a refractory sensed atrial event, PVARP is not extended. Also, PVCs occurring during refractory (PVC-R) do not restart the VA interval.

A PVC annotation is displayed on the EGM, but PVC amplitudes are not displayed as a measured R-wave value.

Reversion

The Analyzer is designed to ensure that pacing cannot be continuously inhibited as a result of non-cardiac noise, such as electromagnetic interference and muscle stimulation. When refractory sensed events are continuously detected, the device reverts to asynchronous pacing at the lower rate.

For the DDD and VDD modes, reversion occurs in the presence of continuously sensed ventricular events, but is not provided for continuously sensed atrial events.

Conducting a basic Analyzer session4

Preparing the Analyzer for use 48

Analyzing the lead 53

Printing reports 58

Ending the analyzer session 60

Chapter 4

Preparing the Analyzer for use

This section provides the basic procedures for preparing to use the Analyzer to perform lead placement analysis.

How to start an Analyzer session

1. Power on the programmer.

2. Select the Analyzer icon on the Tool Palette of the Select Model screen.

- Or -

3. Select the Analyzer icon on the task bar. See “Task bar icons/indicators” on page 25.

Once the Analyzer has been selected, the indicator box to the left of the Analyzer icon on the task bar turns to green.

Details on starting the Analyzer session

After the Analyzer icon is selected, the following can occur:

– Self-test

– Analyzer update

– Select R-Wave filter

The Lead Analysis screen is displayed upon entering an Analyzer session.

The default pacing mode upon starting the Analyzer is ODO (the inhibited mode). To change the pacing mode, see “Changing the pacing mode” on page 34.

Analyzer Reference Guide

Analyzer update

You may be prompted to update the Analyzer after the Analyzer icon is selected. Press [Update Now] to accept the updates prior to your current Analyzer session, or press [Update Later] to skip the update. You will be prompted to update the Analyzer each time you begin an Analyzer session until the updates are installed.

Note: The update completes in approximately 5 minutes. Caution: Do not eject the Analyzer from the programmer or stop

the installation while the update is being installed. If the Analyzer is ejected from the programmer during the update installation, or the update is stopped prior to completion, the Analyzer may become unusable.

Details on selecting the R-Wave filter

You may be prompted to select a filter for R-Wave measurements prior to entering a lead analysis session. Select the appropriate R-Wave filter for the lead analysis. See “How to select the appropriate R-Wave Analyzer filter” on page 50.

Caution: Select the correct filter for R-Wave amplitude measurements. The Analyzer may measure the R-Wave amplitudes greater than or less than the implanted device if the correct filter is not selected for R-Wave amplitude measurements.

Conducting a basic Analyzer session

Preparing the Analyzer for use

Analyzer Reference Guide

1, 2

Chapter 4

Preparing the Analyzer for use

How to select the appropriate R-Wave Analyzer filter

1. Select Original to use the Original R-Wave filter.

-Or-

2. Select New to use the New R-Wave filter. Note: Select New for all Medtronic ICDs and some Medtronic pacemakers. To view a list of the Medtronic pacemakers that use the New R-Wave filter, select [i].

3. Select [OK].

The Lead Analysis screen is displayed after a short self-test sequence.

After the Analyzer is selected, the indicator box to the left of the Analyzer icon on the task bar turns to green.

How to select lead polarity (only applies when using the Model 5436)

Warning: Selecting the bipolar

polarity setting for a unipolar lead will result in loss of capture.

1. Select [Settings...] from the Lead Analysis screen.

The Analyzer Settings window appears.

2. Select the A. Polarity or V. Polarity field.

A menu appears.

3. Select Unipolar or Bipolar.

Analyzer Reference Guide

Details on lead polarity

The Polarity setting is displayed to the right of the chamber designation on the Lead Analysis screen. The default is Bipolar.

If the Polarity of a lead is changed in the middle of a session, all measurements displayed on the Lead Analysis screen are cleared for that lead.

Polarity selection is only available when using the Model 5436 patient cable. The Analyzer treats the leads that are connected to all other cables and adaptors as bipolar. Therefore, use an indifferent electrode when connecting unipolar leads to the Analyzer using the Model 2292 cable, Model 5103 adaptor or Model 5104 adaptor.

For information on connecting cardiac leads to the Model 2292, see the “Instructions for use” section in Chapter 9. For information on connecting cardiac leads to the Model 5103 or Model 5104, read the technical manual supplied with the cables that connect to these adaptors.

How to adjust pacing parameters

Conducting a basic Analyzer session

Preparing the Analyzer for use

1. Select the parameter from the Lead Analysis screen or the Analyzer Settings window.

A window appears, displaying that parameter’s possible values.

2. Select the desired value.

See “Pacing parameters” on page 37 for more information about pacing parameters.

Analyzer Reference Guide

Chapter 4

Preparing the Analyzer for use

How to connect the cable

1. Orient the cable plug so that the latch is facing upward.

2. Insert the cable plug into the receptacle on the Analyzer until it “clicks.”

3. Gently pull on the cable plug after inserting it to ensure that the connection is secure.

4. For instruction on connecting cables to the Model 5103 or Model 5104 Analyzer adaptor, refer to the literature supplied with that adaptor.

How to connect the cardiac lead system

■

For instruction on connecting the cardiac lead system to the Model 2292 Analyzer surgical cable, refer to page 102.

■

For instruction on connecting the cardiac lead system to the Model 5436 Analyzer patient cable, refer to the literature supplied with that cable.

■

For instruction on connecting the cardiac lead system to the cable connected to the Model 5103 or Model 5104, refer to the literature supplied with that cable.

Analyzer Reference Guide

Conducting a basic Analyzer session

Analyzing the lead

How to measure P- and R-wave amplitudes and slew rate

1. Ensure pacing is OFF in the chamber(s) to be measured.

2. To change between the Original or New R-Wave filters, click in the Filter field to switch between either filter. The updated R-wave amplitude measurement is displayed in the next pacing cycle. Note: The R-Wave filter can not be changed when a ventricular pacing mode is selected.

3. The Lead Analysis screen automatically displays the P-wave and R-wave amplitudes and Slew Rate for the connected lead(s).

Note: If measurements are not being displayed, adjust the A. or V. Sensitivity setting.

4. When Pacing is ON, the last values measured are displayed but not updated. Sensing measurements resume once Pacing is OFF.

Analyzing the lead

Analyzer Reference Guide

Chapter 4

Analyzing the lead

How to measure lead impedance

Details about measuring lead impedance

If no value is shown, intrinsic activity may be inhibiting pacing. Increase the Lower Rate to at least 10 min patient’s intrinsic rate.

The minimum output for the Impedance measurement is 5 V. If the pacing amplitude is set less than 5 V, the Analyzer increases it to 5 V for the measurement. If the pacing amplitude is set at or above 5 V, impedance is determined at the selected amplitude.

1. Increase the Lower Rate to 10 min

-1

(ppm) above the

patient’s intrinsic rate.

2. Select Pacing “ON” in either the A. Lead or V. Lead column. The Pacing value toggles between ON and OFF.

3. An Impedance measurement, based on the first output pulse, is displayed.

4. To update the impedance, select [Impedance] once, or select and hold [Impedance] for a beat-by-beat update.

-1

(ppm) above the

The pulse width is set to 1.0 ms for the Impedance measurement.

Analyzer Reference Guide

Conducting a basic Analyzer session

Analyzing the lead

How to determine stimulation thresholds

Caution: Monitor the

patient’s blood pressure and ECG throughout this procedure.

1. Make sure that Pacing for the lead is ON.

2. Select [Threshold...] for that lead from the Lead Analysis screen.

3. Make sure that the Lower Rate is 10 min above the patient’s intrinsic rate.

4. Use the buttons on the Amplitude Threshold window to determine the pacing threshold:

a. To change the test

amplitude in whole volt increments, select [1V], [2V], [3V], [4V], or [5V].

b. To increase the test

amplitude 1 V at a time (up to 10 V), select [>].

c. To gradually increase or decrease the test amplitude and find the precise

threshold, select [+0.1 V] or [–0.1 V].

The minimum amplitude at which capture is consistently maintained, is the threshold.

5. Perform a diaphragmatic stimulation test by selecting [10 Volt Press and Hold].

6. Save the threshold by selecting [Save as Threshold].

Note: The threshold value can be printed only if it is saved.

7. If you do not want to save the threshold, select [Close].

-1

(ppm)

Details about determining stimulation thresholds

The real-time pacing current appears on this window. Note: If the Pulse Width is set to less than 0.05 ms, there will be

no current measurement.

The Lower Rate can be adjusted from the Amplitude Threshold window by changing the value in the Lower Rate field.

Analyzer Reference Guide

Chapter 4

Analyzing the lead

How to save the lead measurements

1. Select [Save...] at the bottom

of either the A. Lead or V. Lead column on the Lead Analysis screen.

All measurements for the current lead position are displayed.

2. Specify the chamber you want to map the saved measures to by clicking in the Lead field and selecting Atrial, RV, or LV.

3. Select [Print] to print the measured values on the chart recorder.

4. Select [Save] to save the measurements and close the window.

5. Select [Discard] to close the window without saving the measurements.

Analyzer Reference Guide

Note: If the New R-Wave filter was selected for the amplitude measurement, the R-Wave value displays a caret (^) next to the R-Wave mV measurement, and ^New Filter is displayed in the lower left corner of the Save - Ventricular Lead Measures screen.

Conducting a basic Analyzer session

Analyzing the lead

How to print saved measurements and save them to USB or diskette

1. Select [View Saved...] from the

Lead Analysis screen.

The most recent measures are displayed at the bottom of the list. One saved measurement for each lead (RV, LV, A) can be selected at a time.

2. Print a Saved Measures report on the strip chart recorder.

a. Select up to three sets of

saved measures (one per lead - RV, LV, A).

b. Select [Print].

Note: The R-Wave mV value displays a caret (^) after the measurement to identify that the New filter was selected when the R-Wave measurement was taken.

3. Save a measure to a USB flash drive or diskette. a. Select up to three sets of saved measures (one per lead - RV, LV, A). b. Select the Patient field, type a patient identifier using the displayed keyboard,

and select [Enter].

c. Select [Save to Disk]. The Save to Disk - Insert Diskette screen appears. Make

sure a USB flash drive is attached, or diskette is inserted in the diskette drive, and select [Start]. The measure is saved to the USB flash drive or diskette.

Note: The diskette drive is functional only when a USB flash drive is not in use. Before using the diskette drive, ensure that a USB flash drive is not connected to the programmer. For further instruction, see the 2090 Programmer Reference Guide.

4. To return to the Lead Analysis screen, select [Close].

Details about viewing and printing saved measurements and saving them to diskette

The Saved Measures window shows all sensing and pacing measurements that have been saved since the start of the session.

Analyzer Reference Guide

Chapter 4

Printing reports

How to print reports

If [Save...] was not selected on the Lead Analysis screen after lead measurements were taken, the lead measurements will not appear in the Saved Measures window, even if the threshold was saved in the Amplitude Threshold window.

Measures are saved to diskette in XML format.

Warning: During the Save to Disk operation, the [Emergency]

button remains displayed and all emergency functions are available. If a disk error occurs during a save, however, there may be a delay in initiating the Emergency screens. Therefore, it is suggested that you not save to disk when a possibility exists that emergency functions might be needed immediately.

The strip chart recorder can provide the following reports during an Analyzer session.

Note: Printing will stop if you use the Programmer icon on the task bar to toggle to a programmer session before the printout of the analyzer session is finished.

Report How to print the report

Real-time Continuous Waveforms Select the desired paper speed button: [50 mm/sec],

[25 mm/sec] or [12 mm/sec], on the programmer at any time during the Analyzer session.

Saved Lead Measurements

1. Select [View Saved...] from the Lead Analysis

screen.

2. Select [Print] after selecting a line of values.

Up to 3 measurements at a time can be printed.

Single Complex EGM Strip Select [Print] from the Freeze or Strips... window.

Frozen Continuous Waveform Strip

Analyzer Reference Guide

Select [Print] from the Freeze or Strips... window, or from the Conduction Test Strip window.

Conducting a basic Analyzer session

Printing reports

Report How to print the report

Conduction Test Select [Print] from the Setup screen after a test has

been run. Note: This report can only be printed from the test screen

displayed immediately after [STOP and Restore] is pressed.

Pulse Width/Amplitude Threshold Select [Print] from the Results screen after a test has

been run. Note: This report can only be printed from the test screen

displayed immediately after [STOP and Restore] is pressed.

Analyzer Reference Guide

Chapter 4

Ending the analyzer session

How to end the Analyzer session

1. Select [End Session...] from

the Lead Analysis screen or from one of the Advanced feature setup screens. If the Analyzer is in a pacing mode, the displayed warning appears.

2. If you want to return to the Lead Analysis screen to end pacing:

a. Select [Cancel] to close the

End/Save Session window and return to the Analyzer session.

b. Set the Analyzer to an

appropriate mode that senses and paces.

c. Gradually reduce the Lower

Rate below the patient’s intrinsic rhythm.

d. Once a spontaneous rhythm

is established, discontinue pacing.

e. Select [End Session...]

again. The End Analyzer Session window appears without the pacing warning.

3. Select [End Now] to close the End Analyzer Session window and return to the

Analyzer session. (Again, if you want to return to the Analyzer session without ending, select [Cancel] to close the End Analyzer Session window and return to the Analyzer session.)

4. Disconnect the pacing leads from the Analyzer.

Note: All saved data is lost once [End Session] is selected.

Analyzer Reference Guide

Conducting a basic Analyzer session

Details about ending the Analyzer session

All pacing operations are discontinued once [End Now] is selected.

Note: To preserve the maximum life of the backup battery, end the Analyzer session before turning the programmer off. If the programmer is turned off without ending the session, the Analyzer runs for a short time using the backup battery (see “Power loss and loss of host communication” on page 44).

Ending the analyzer session

Analyzer Reference Guide

Using the concurrency feature5

What is concurrency? 64

Concurrency Task Bar controls 66

How to tell if your device supports concurrency 67

When you can switch sessions using the task bar 67

Setting up for an implant 68

Pacing therapy 69

Printing with concurrency 71

Exporting lead measurements from the analyzer session to the device session 72

Chapter 5

What is concurrency?

Concurrency allows you to have a device session and an analyzer session running at the same time, and quickly switch from one to the other without having to end or restart sessions.

For example, after starting both a device and an analyzer session, you can switch to the device session and perform patient pre-programming tasks. When the physician is ready for lead testing, you can quickly switch back to the analyzer session and take the lead measurements. Then you can save the analyzer lead measurements, export them to the Patient Information parameters in the device session, and switch to the device session to complete pre-programming tasks and program the device.

Independent operation of device and analyzer sessions with concurrency

When running concurrently, the analyzer and device sessions behave independently of one another, just as if they were running as stand-alone programs. Programming or changing analyzer parameters does not affect the device and vice versa. When you switch away from a session, that session is idle until you switch back to it.

Data from the analyzer and device sessions remain separated and are only displayed in the proper session. Markers and EGM data are not intermixed between the sessions. An exception is the ECG, which is a programmer input and is not obtained directly from either the device or the analyzer. Changes to the ECG gain in one session are carried over to the other session.

Note: It is important when using concurrency to maintain an awareness of whether the patient is connected to the analyzer or to the device in case you need to switch quickly to the proper session for pacing support.

Functionality available in the programmer desktop with concurrency

The programmer desktop consists of the functions associated with the Select Model screen, including the [Find Patient] button and the selections that can be accessed via the Tool Palette icons (Select Model, Print Queue, Programmer, and Analyzer).

Analyzer Reference Guide

Using the concurrency feature

What is concurrency?

If you have started the programmer desktop but have not yet started a device session, you can start an analyzer session and switch between it and the programmer desktop. However, once you have started an analyzer session, the following programmer desktop functions are not available:

■ Tool Palette icons: Select Model, Print Queue, Programmer,

and Analyzer

■ Installing new programmer software (and the other functions

accessible with the Programmer icon)

■ Switching to the Vitatron Model Selection screen

■ Freeze, Strips, and Adjust

To re-enable the desktop functionality, end the analyzer and device sessions. For information about ending the analyzer session, see “Ending the analyzer session” on page 60.

The Find Patient, Start, and model selection options are available whether or not you have started an analyzer session. From the programmer desktop, you can select [Find Patient] to start a device session.

Analyzer Reference Guide

Chapter 5

Concurrency Task Bar controls

Figure 5-1. The concurrency controls on the task bar

1 Analyzer icon

2 Device icon

The task bar contains the two concurrency controls: the Analyzer icon (1), and the Device icon (2). If your device supports concurrency, you can use these icons to switch between a device session and an analyzer session.

Table 5-1. Task bar icons/indicators

Icon Name Function

indicator box

Analyzer icon Used to start an analyzer session or,

if the device supports concurrency, to switch to an analyzer session from a device session. When an analyzer session is running, the indicator box turns green.

Device icon 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.

Analyzer Reference Guide

Using the concurrency feature

How to tell if your device supports concurrency

There are two ways to tell if your device supports concurrency:

■ If your device supports concurrency, the concurrency icons on

the task bar remain enabled after the device session has been started, and you can use them to switch between device and analyzer sessions. If your device does not support concurrency, these icons are disabled and are grayed out to indicate that you cannot use them to switch sessions:

Figure 5-2. Disabled concurrency icons

1 Disabled Analyzer icon

2 Disabled Device icon

■ If your device does not support concurrency, the following

message is displayed when you switch from an analyzer session to the Select Model screen and:

– select the [Find Patient] button

-or-

– manually select a device application from the list and then

select the [Start] button:

If your device does not support concurrency, you must end the analyzer session before you can start a device session.

When you can switch sessions using the task bar

The concurrency icons on the task bar are not selectable when:

■ you are in a screen that requires a user response ([OK],

[Close]). An example is the Analyzer Settings screen.

■ you have started a Start/Stop test.

Analyzer Reference Guide

Chapter 5

Setting up for an implant

To switch between sessions when a response screen or test is open, you must close the response screen or stop the test, and then switch to the appropriate session.

Setting up for an implant

This procedure explains how to start the device and analyzer sessions concurrently in preparation for performing a lead implant.

How to set up for an implant

■ the wait cursor or Please Wait window is displayed, indicating

that processing is in progress.

1. Prepare the 2090 Programmer for the implant procedure by connecting the ECG cables, the analyzer patient cable, and the analog outputs and/or video outputs.

Refer to the 2090 Reference Guide and the device reference guide for instructions. Refer to the about connecting the analyzer patient cable.

2290 Reference Guide for information

2. Turn on power to the 2090 Programmer.

3. Start a device session. If telemetry is established with the device, the programmer automatically starts the application, interrogates the device, and displays the Quick Look screen for the device.

Note: The indicator box to the left of the Device icon is filled in (green), indicating that a device session has been started:

Analyzer Reference Guide

4. Start the analyzer session by selecting the Analyzer icon.

Note: The indicator box on the analyzer icon is filled in (green), indicating that an analyzer session has been started:

Note: It takes about 15 seconds to start the analyzer session. However, it takes only a few seconds to switch to an analyzer session once it has been started.

The analyzer and device sessions are now running concurrently. Proceed with your implant steps as you normally would, keeping in mind that now you can quickly switch between analyzer tasks (such as performing a lead analysis), and device tasks (such as pre-programming the device).

Using the concurrency feature

Pacing therapy

The concurrency feature provides flexible options for delivering pacing therapy.

Background pacing with the analyzer

Concurrency allows you to use the analyzer as a background pacemaker while you are working in the device session. When pacing is on in the analyzer session, it will remain on in the background after you switch to the device session. If you want to deliver pacing therapy via the analyzer, you must first switch to the analyzer session. With concurrency, this takes only a few seconds.

How to perform background pacing with the analyzer

1. Switch to the analyzer session.

2. Check patient cable connections.

3. Select Pacing ON on the desired A or V channel, or select a pacing mode such as DDD. (For more information, refer to the 2290 Analyzer Reference Guide.)

4. Switch back to the device session and continue with device tasks such as preprogramming the device. The background pacing will continue through the analyzer while you perform tasks in the device session.

Note: To turn off or change the analyzer pacing parameters, first switch back to the analyzer session.

Pacing therapy

Emergency pacing through the analyzer

Emergency pacing can be delivered via the analyzer. If an emergency situation arises and the patient cable is connected to the implanted ventricle lead, emergency pacing can be initiated in the analyzer session. If you want to deliver emergency therapy via the analyzer, you must first switch to the analyzer session. With concurrency, this takes only a couple of seconds.

Analyzer Reference Guide

Chapter 5

Pacing therapy

How to perform emergency pacing through the analyzer

1. Be sure that the analyzer session is displayed. Switch to the analyzer session if necessary.

2. Select the Emergency VVI hard or soft key. (Refer to the 2090 Programmer Reference Guide for information about these keys.)

3. The words, Emergency pacing is on, appear on the status bar.

4. A message window appears, indicating that Emergency VVI pacing is being delivered through the analyzer.

5. Check the analyzer cable connections to ensure that the patient is receiving the emergency therapy.

Note: When pacing is on in the analyzer session, pacing remains on through the analyzer after you select [Close], and after you switch to the device session. To modify the analyzer pacing parameters after switching the device session, you must switch back to the analyzer session and change the parameters manually.

Analyzer Reference Guide

Using the concurrency feature

Printing with concurrency

How to perform emergency pacing through the device

1. Be sure that the device session is displayed.

2. Select Emergency using either the [Emergency] button on the screen or the red Emergency hard key.

Note: See the device reference guide for information about emergency therapies.

3. When the red Emergency hard key is used, a message window appears indicating that Emergency VVI pacing is being delivered through the device.

4. Check the device lead connections to ensure that the patient is receiving the emergency therapy.

Printing with concurrency

Full-size reports that are printing via the print queue in the device application will continue to print for as long as the device session is active. Reports that are printed to the strip chart recorder will be truncated at the time of a switch between analyzer and device sessions.

To prevent strip chart recorder reports from truncating, wait for the reports to finish before switching sessions. If a report truncates, you can reprint the report from the appropriate session when convenient.

Analyzer Reference Guide

Chapter 5

Exporting lead measurements from the analyzer session to the device session

When analyzer and device sessions are running concurrently, you can export the saved lead measurements from the analyzer session into the patient information parameters in the device session. You can then store the exported measurements into the device as viewable and printable records of the lead measurements as taken in the analyzer at implant.

This procedure assumes that you have started a device session, and then started an analyzer session by selecting the Analyzer icon on the task bar, and that you have taken lead measurements as explained in the 2290 Analyzer Reference Guide.

Analyzer Reference Guide

Using the concurrency feature

Exporting lead measurements from the analyzer session to the device session

How to save the lead measurements

1. Select [Save] at the bottom of the A. Lead or V. Lead column, depending on whether you are testing an atrial or ventricular lead.

The Save Lead Measures screen appears.

2. Select the Lead field. A drop-down list appears, allowing you to select the lead associated with the measurement set - Atrial, RV, or LV.

This selection will be used to map the analyzer session Lead Measurement Data to the Implant Data field on the Patient Information screen in the device session. Note: The R-Wave mV value displays a caret (^) after the measurement to identify that the New filter was selected when the R-Wave measurement was taken. ^New Filter is also displayed above the [Print] button.

3. Select [Save] to save the lead measurements.

Analyzer Reference Guide

Chapter 5

Exporting lead measurements from the analyzer session to the device session

How to export the saved lead measurements to the device

1. Select [View Saved]. The

Saved Measures screen appears.

2. Select saved measurements for export by tapping on them. You can select up to 1 measurement for each lead type. The [Export] button is enabled.

3. Select [Export]. The selected settings are exported to the Patient Information parameters in the device session. An asterisk (*) appears to the right of the exported item in the Lead column if that this item has recently been exported. *Recently exported is also displayed above the [ button. Note: The R-Wave mV value displays a caret (^) after the measurement to identify that the New filter was selected for R-Wave when the measurement was taken. ^New Filter is also displayed above the [

Save to disk...] button.

4. If necessary, export other saved measurements. When you are finished, select [Close].

Note: If the [Export] button is not available, make sure that you have started your device session and have selected the measurements to export.

Save to disk...]

Analyzer Reference Guide

Using the concurrency feature

Exporting lead measurements from the analyzer session to the device session

How to store exported lead measurements in the device

1. Switch to the device session by selecting the Device icon on the task bar. See “Task bar icons/indicators” on page 25).

2. Notice the Program pending Patient information message.

3. Select the Patient icon to the right, and then select Patient information from the menu. The Patient Information screen appears. Fields containing pending information (for information that is ready to be programmed to the device) are highlighted in blue.

Analyzer Reference Guide

Chapter 5

Exporting lead measurements from the analyzer session to the device session

4. Select the blue-highlighted Implant field. The Implant screen appears, listing the lead data that has been exported from the analyzer. The data is mapped to Atrial, RV or LV columns in accordance with your selections in the Lead field of the Save Lead measurements screen in the analyzer session. You can add or change data by selecting a field and typing information using the displayed keyboard. Note: The R-Wave mV value displays a caret (^) after the measurement to identify that the New filter was selected for R-Wave when the measurement was taken.

5. When the data displayed on the Implant window is correct, select [OK].

(Continued)

Analyzer Reference Guide

Using the concurrency feature

Exporting lead measurements from the analyzer session to the device session

6. If the information on the Patient Information screen is correct and complete, select the [PROGRAM] button. The patient information, including the lead measurements from the analyzer, is written into the patient information parameters of the device.

The message, Programming Successful, appears briefly at the top of the live Rhythm Waveform window. Because this message is part of the waveform sweep, it disappears when a new waveform cycle begins.

The patient information is available as analyzer implant information in the device for viewing and printing.

Analyzer Reference Guide

Using advanced features6

Conduction tests 80

Pulse width/amplitude threshold test 82

Rapid atrial stimulation 84

Chapter 6

Conduction tests

The following two types of conduction tests are available.

Retrograde conduction – Use this test to determine if paced ventricular activity is conducted back to the atrium. Test results are useful in selecting the appropriate post-ventricular atrial refractory period (PVARP) for the implanted device.

This test automatically sets pacing to the VVI mode.

Antegrade conduction – Use this test to analyze the AV conduction characteristics of the patient.

This test automatically sets pacing to the AAI mode.

How to perform a conduction test

1. Select the Advanced icon from the tool palette, then select Conduction Tests.

2. The default test is Retrograde conduction. To perform an Antegrade conduction test, select the Test Type field and select Antegrade.

3. If necessary, adjust the test output amplitude value.

4. Select [START Test].

5. Use the Test Rate increase/decrease buttons to check conduction at various rates.

6. To stop the test, select [STOP and Restore].

7. Select [Print] to print a conduction test report.

[Print] is displayed at the bottom of the screen after [STOP and Restore] is selected.

Analyzer Reference Guide

How to view and print conduction test strips

Using advanced features

Conduction tests

1. Select the Test Strip icon to view the last 10 seconds of the test.

Note: The [Save] button on the Test Strips window is not selectable because the strip is automatically saved to the Strips... window.

2. Select [Print] from the Test Strips window to print it now.

3. Select [Close] to return to the Conduction test setup window.

Details about conduction tests

If both the A. EGM and the V. EGM traces are not displayed in the live rhythm monitor window during other Analyzer functions, the live rhythm monitor window changes so that the A. EGM and the V. EGM traces are displayed, along with two ECG traces.

The Test Values go into effect when [START Test] is selected. Pacing is restored to the values shown as Present Values when [STOP and Restore] is selected.

VA intervals (Retrograde conduction) or AV intervals (Antegrade conduction) are annotated in the live rhythm monitor window.

The conduction test report can be printed only from the test screen displayed immediately after [STOP and Restore] is pressed. The report is not added to the saved measurements list of parameters. The report is not available after the test session is exited or a new test session is started.

Analyzer Reference Guide

Chapter 6

Pulse width/amplitude threshold test

Use the Pulse Width/Amplitude Threshold test to manually determine the amplitude threshold at various pulse widths or the pulse width threshold at various amplitudes.

Considerations

Caution: To avoid prolonged loss of capture, the following

procedures are recommended.

■ For Amplitude thresholds at various Pulse Widths, start at

a high Amplitude and decrease the Pulse Width to find the first threshold. Increase the Pulse Width before finding each subsequent Amplitude threshold.

■ For Pulse Width thresholds at various Amplitudes, start at

a wide Pulse Width and decrease the Amplitude to find the first threshold. Increase the Amplitude before finding each subsequent Pulse Width threshold.

How to setup a pulse width or amplitude threshold test

Analyzer Reference Guide

1. Select the Advanced icon from the tool palette. Then select Pulse Width/Amplitude Test from the Advanced features menu.

2. Select the desired Mode, Chamber, Lower Rate, Amplitude, Pulse Width, and AV Interval (dual-chamber modes only) by selecting the fields and selecting the desired values from the menus that are displayed.

3. Select [START Test].

Using advanced features

2a 2b

Pulse width/amplitude threshold test

How to perform a pulse width or amplitude threshold test

1. Select either the Chart or List View, depending on whether you prefer to view the data as a graph or list.

2. Adjust the Pulse Width or Amplitude to a particular value using the increase and decrease buttons.

a. Use the decrease button

to decrease the Pulse Width or Amplitude until loss of capture is observed on the live rhythm monitor.

b. Use the increase button

to increase the Pulse Width or Amplitude until capture is consistently maintained. This is the threshold.

3. Select [Plot Point] (in Chart View) or [Save Point] (in List View) to save the threshold.

4. Repeat steps 2 and 3 for as many pulse width or amplitude thresholds as desired.

5. Select [STOP and Restore] to end the test.

6. To delete a threshold, select the threshold from the list (in List View), and then

select [Delete].

7. Select [Print] to print a test report. [Print] is displayed after [STOP and Restore] is

selected.

8. Select [Return to Setup] to run another test.

Details about pulse width and amplitude threshold tests

The Test Values go into effect when [START Test] is selected. Pacing is restored to the values shown as Present Values when [STOP and Restore] is selected.

If a test was performed since the Pulse Width/Amplitude Threshold Test window was opened, the threshold points determined during the previous test are displayed.

Analyzer Reference Guide

Chapter 6

Rapid atrial stimulation

Considerations

Pressing and holding the increase or decrease button will result in rapid changes in the value. The value will not take effect until the button is released.

The results can be printed only from the test screen displayed immediately after [STOP and Restore] is pressed.

The Analyzer provides high rate atrial pacing (to 800 min-1 (ppm)) to overdrive and terminate atrial tachyarrhythmias.

Warnings:

■ Rapid stimulation is intended for use in the atrium only.

■ Use of high rates in the atrium could result in high-rate

conduction to the ventricle.

Note: The Analyzer provides backup VVI pacing, if necessary, during rapid atrial stimulation.

Analyzer Reference Guide

How to setup Rapid Atrial Stimulation

Using advanced features

Rapid atrial stimulation

1. Select the Advanced icon from the tool palette. Then select Rapid Atrial Stimulation from the Advanced features Menu.

2. Enable/disable ventricular pacing by selecting the Backup VVI Pacing field.

The Analyzer defaults backup ventricular pacing to ON if the present pacing mode provides ventricular pacing.

3. Adjust the delivery values for atrial amplitude, backup ventricular rate, and backup ventricular amplitude if necessary.

4. Select the atrial delivery rate by selecting the Delivery Rate field and selecting a value from the menu displayed.

How to deliver Rapid Atrial Stimulation

1. Select [START AOO

Delivery] to initiate rapid

atrial stimulation.

Note: [START AOO Delivery] is not a “press and hold” button. Select, then, release the button to initiate Rapid Atrial Stimulation.

2. If necessary, use the

increase/decrease buttons to change the rate by 10

-1

min

(ppm) during

delivery.

3. Select [STOP Delivery] to

end rapid atrial stimulation.

Analyzer Reference Guide

Maintenance7

Installing the Analyzer 88

Replacing the backup battery 89

Cleaning the Analyzer 90

Functional test, maintenance and safety checks 91

Service 93

Disposal of Analyzer 93

Special notice 93

Medtronic limited warranty 94

Chapter 7

Installing the Analyzer

How to install the Analyzer

If the Analyzer icon is displayed on the Select Model screen of the programmer, the Analyzer software is installed on the programmer. To use the Analyzer, follow the installation instructions below.

If the Analyzer icon is not displayed on the Select Model screen, the Analyzer software is not installed on the programmer. Contact your local Medtronic sales representative to receive the Analyzer software. Then follow the instructions below to use the Analyzer.

1. Loosen the screw that secures the Analyzer slot cover to the programmer

2. Remove the cover.

Analyzer Reference Guide

3. Orient the Analyzer module so that the screw is in the lower right-hand corner.

4. Slide the Analyzer module into the slot.

5. Press the Analyzer module gently until it is flush with the outside of the programmer.

6. Tighten the screw to secure the Analyzer module.

Replacing the backup battery

The Analyzer backup battery level is checked during the self-test that occurs when the Analyzer session is entered. Replace the backup battery if the Low Battery message appears.

Caution: Do not replace the backup battery while the Analyzer is connected to the patient. When the Analyzer is removed from the programmer, the connector port on the backside of the Analyzer could provide a low-resistance path to the myocardium for electrostatic discharge (ESD). Also, the backup battery connects to the circuitry which connects directly to the patient. The battery connector could, therefore, provide a low-resistance path to the myocardium for ESD or leakage currents.

Remove the battery when the Analyzer is stored for extended intervals.

At the end of its usefulness, dispose of the backup battery in accordance with local environmental requirements.

Maintenance

Replacing the backup battery

Analyzer Reference Guide

Chapter 7

Cleaning the Analyzer

How to replace the backup battery

1. Disconnect the patient from the Analyzer.

2. Remove the Analyzer from the programmer.

3. Use a small blunt object, such as the tip of a ballpoint pen, to press down on the pin holding the battery compartment closed.

4. While the pin is pressed down, slide the battery compartment cover off.

5. Replace the old battery with a new 9 V alkaline battery (Type 6LR61 or NEDA 1604A [Energizer 522 or equivalent]) to ensure maximum pacing longevity in the case of a power loss.

6. Slide the battery cover back on until it “clicks.”

7. Reinstall the Analyzer module and secure the screw.

Cleaning the Analyzer

Cautions:

■ Do not allow liquid to get into the Analyzer.

■ Do not immerse the Analyzer in any liquid or clean it with

aromatic or chlorinated hydrocarbons.

■ The Analyzer cannot be sterilized.

Clean the exterior surfaces of the Analyzer with a damp sponge or soft cloth moistened with water, mild detergent, or alcohol.

Analyzer Reference Guide

Functional test, maintenance and safety checks

Functional test at installation

Prior to putting the Analyzer into service for the first time, the device and its accessories should be visually inspected and tested for operability by a designated Medtronic person. Visual inspection requires examining the Analyzer case for mechanical damage, verifying that all connectors are properly fastened and checking for insulation damage to the accessory cables.

Since the Analyzer is a programmer accessory, verify operation by turning on the programmer and checking monitor functionality.

Maintenance

Medtronic recommends that the user should test the Analyzer for operability and also visually inspect the Analyzer and its accessories (e.g., cables) prior to each use as outlined in the section above.

Caution: If the Analyzer has mechanical damage or if any of the connectors are damaged, contact your Medtronic representative. If there is insulation damage to the accessory cables, please replace the part and dispose of it according to local regulations or return the part to Medtronic.

Maintenance

Safety checks

Safety checks require a functional test and electrical safety tests once every two years. It is not necessary that technical and safety inspections are performed by Medtronic personnel; however, technical and safety inspections of the programmer and its accessories must be performed by persons, who, based on their training, knowledge, and practical experience, are capable of adequately performing such inspections and who do not require instructions with regard to the technical and safety inspection.

Analyzer Reference Guide

Chapter 7

Functional test, maintenance and safety checks

Required electrical safety according to IEC 60601-1 clause 18 and 19:

Tests Requirement

Enclosure leakage current ≤ 0.1 mA

Patient leakage current ≤ 0.01 mA

Patient auxiliary current D.C. ≤ 0.01 mA

Patient auxiliary current A.C. ≤ 0.01 mA

Warning: If technical and safety inspection reveals a defect which could harm the patient, clinicians, or third parties, the device should not be used until it has been properly repaired. The operator must immediately notify Medtronic of these defects.

Practical measurements

■ Rate test

■ Rapid atrial pacing

■ Pulse width

■ AV interval

■ Output

■ Sensitivity

■ Slew rate

■ Lead impedance

■ Frequency response

■ Refractory periods

■ AC (50 or 60 Hz) interference rejection: 1.0 mV peak-to-peak

noise while sensing 1.0 mV, 40 ms sine-squared test pulses, with A. and/or V. Sensitivity set to 0.5 mV.

Caution: Do not open the Analyzer as this will void the warranty (see the limited warranty on page 94). This caution does not apply to opening the battery compartment.

Analyzer Reference Guide

Medtronic does not recommend field repair of the device. For service or repair contact your local Medtronic representative at the appropriate address or telephone number listed on the back cover.

Service

Maintenance

Service

Medtronic employs highly trained representatives and engineers located throughout the world to serve you and, upon request, to provide training to qualified hospital personnel in the use of Medtronic products. Medtronic also maintains a professional staff to provide technical consultation to product users. For medical consultation, Medtronic can often refer product users to outside medical consultants with appropriate expertise. For more information, contact your local Medtronic representative, or write or call Medtronic at the appropriate address or telephone number listed on the back cover.

The Analyzer, Medtronic 2290 has been carefully engineered, manufactured and quality tested to provide trouble-free service. Should service or repair be necessary, contact your local Medtronic representative at the appropriate address or telephone number listed on the back cover.

A serial number identifying each individual device is printed on the device. This serial number should be referenced in any correspondence regarding this device.

Disposal of Analyzer

Return the Analyzer to Medtronic for proper disposal.

Special notice

The Medtronic 2290 Analyzer is a microprocessor-based device intended to analyze the electrical performance of a cardiac lead system. The Analyzer operates in clinical environments that place limitations on the design and function of the device. These limitations unavoidably reduce the potential performance of the Analyzer despite the exercise of due care in design, component selection, manufacture and testing prior to sale. Performance may be affected by medical instrumentation, electrosurgical units, electromagnetic interference, and other environmental stresses noted in this manual. Consequently, no representation or warranty is made that cessation of function will not occur.

Analyzer Reference Guide

Chapter 7

Medtronic limited warranty

For complete warranty information, see the accompanying card enclosed in the package.

Analyzer Reference Guide

Analyzer specifications8

Standards 96

Storage and operating environment 96

Measurement parameters 96

Pacing parameters 97

9 V backup battery 98

Chapter 8

Standards

The Analyzer complies with the following standards.

EMC CISPR 11, Class A

EN 60601-1-2, including subsets EN 61000-4-2, -3,-4, -5

Patient safety

UL 2601-1, grounded construction, ordinary connection CSA 601.1, Class 1, Type CF EN 60601-1, Class 1, Type CF, ordinary equipment, no

sterilization, benign environment, continuous mode of operation, and applied part specifically designed for connection directly to the heart

Storage and operating environment

Storage temperature -40 °C (-40 °F) to 65.5 °C (150 °F)

Operating temperature 10 °C (50 °F) to 35 °C (95 °F)

Storage humidity 5 to 95 % at 35 °C (95 °F)

Operating humidity 8 to 80 %

Measurement parameters

Parameter Range Resolution Accuracy

P-Wave amplitude

R-Wave amplitudeb0.6–30 mV 0.1 mV The greater of

Analyzer Reference Guide

Impedance (A. and V.)

Slew rate

Pacing current 0.1–25 mA 0.1 mA The greater of

All measurements and accuracies assume a noise-free environment.

Amplitude measurement specifications are based on a 40 ms sine2 input signal.

Impedance range based on a 5 V output setting.

0.3–30 mV 0.1 mV The greater of ±0.2 mV or ±10 %

±0.2 mV or ±10 %

200–2499 Ω 2500–4000 Ω

2% of value 3 % of value

±10 % ±15 %

0.1–4.0 V/s 0.1 V/s The greater of ±0.2 V/s or ±10 %

±0.2 mA or ±10 %

Slew rate accuracies are defined over the range of 20 to 150 Hz input signals only, corresponding to input pulse widths of 6 to 50 ms.

Pacing parameters

Parameter Range Resolution Accuracy

Modes VOO, VVI, AOO,

Lower rate - AOO, AAI, VOO, VVI, DOO

DDD, VDD

Upper rate 80–220 min

Amplitudes (A. and V.) 0.1–10.0 V

Pulse width (A. and V.) 0.02–0.09 ms

AV interval (sensed) 20–350 ms 10.0 ms The greater of

AV interval (paced) 20–350 ms 10.0 ms ±2 ms

Rapid atrial stimulation 200–800 min

Atrial refractory 200–500 ms 25 ms +3/-25 ms

Ventricular refractory

Atrial sensitivity

Ventricular sensitivity

Polarity (A. and V.)

Analyzer specifications

Pacing parameters

AAI, DOO, DDD,

VDD, ODO

(ppm)

-1

30–95 min

100–220 min

(ppm)

30–95 min

-1

(ppm)

100–

210 min-1(ppm)

-1

(ppm)

0.1–1.5 ms

-1

(ppm)

250 ms – +3/-25 ms

0.25–0.75 mV

1.0–4.5 mV

5.0–9.0 mV 10–20 mV

0.5–0.75 mV

1.0–4.5 mV

5.0–9.0 mV 10–20 mV

unipolar/bipolar – –

––

-1

5min

(ppm)

10 min

-1

±2 %

(ppm)

-1

5min

(ppm)

10 min

-1

±2 %

(ppm)

10 min

-1

±2%

(ppm)

0.1 V

The greater of

0.1 V or ± 5%

0.01 ms

0.1 ms

The greater of

±2 ms or ±2 %

±5 ms or ±5 %

-1

10 min

±2 %

(ppm)

0.25 mV

0.5 mV

1.0 mV

The greater of

0.2 mV or ±5 %

5mV

0.25 mV

0.5 mV

1.0 mV

The greater of

0.2 mV or ±5 %

5mV

Analyzer Reference Guide

Chapter 8

9 V backup battery

Ventricular refractory periods are not programmable or user accessible

Sensitivity specifications are based on a 40 ms sine2 input signal.

Pacing Parameters (continued)

Parameter Range Resolution Accuracy

Atrial blanking

after atrial pace (PAAB)c, after atrial sense

(SAAB)

after ventricular pace

(PVAB)

after ventricular sense

(SVAB)

Ventricular blanking

after atrial pace (PAVB) after ventricular sense

(SVVB)

after ventricular pace

(PVVB)

Atrial and ventricular blanking intervals are non-programmable.

Blanking tolerances are based on a 1 ms sine2 input twice the minimum amplitude at which sensing occurs.

Atrial blanking is equal to the AV Interval in the VDD and DDD modes.

Atrial blanking intervals vary with the rate setting.

SAAB is reduced to 50 ms for atrial senses occurring inside PVARP.

Atrial blanking intervals are included to prevent the sensing of retrograde and far-field R-waves.

PVAB is reduced to 125 ms during the retrograde conduction test.

PVAB and SVAB cannot exceed PVARP and will be truncated for PVARP settings less than 220 ms.

a, b

c, d, e

d, f, g, h

VVI/VOO

DDD/VDD

f, h

a, b

160–300 ms

150–350 ms 200–220 ms

150 ms

40 ms

125 ms

200 ms

–

– –

–

+3/-25 ms

+3/-25 ms +3/-25 ms

+3/-25 ms

9 V backup battery

The expected fresh battery longevity is 50 minutes.

Analyzer Reference Guide

Device description 100

Intended use 100

Warnings and precautions 101

Maintenance 102

Instructions for use 103

Special notice 105

Medtronic disclaimer of warranty 105

Accessories9

100

Chapter 9

Device description

The Medtronic Model 2292 Analyzer surgical cable features four alligator clips for connecting to the connector end of implantable pacing leads. The alligator clips are color-coded in red (+) and black (-). The atrial alligator clips are indicated by the word “ATRIUM” on a blue band; the ventricular alligator clips are indicated by the word “VENTRICLE” on a white band. The cable is approximately 3.66 m (12 ft) in length (Figure 9-1).

The cable is reusable and supplied non-sterile. The cable must be sterilized before being used.

Figure 9-1. Medtronic Model 2292 Analyzer surgical cable

Intended use

Analyzer Reference Guide

The Model 2292 Analyzer surgical cable is intended to connect the Analyzer, Medtronic Model 2290 to implantable unipolar or bipolar pacing leads.

Medtronic 2290 Reference Guide

Specifications and Main Features

Frequently Asked Questions

User Manual

Contents

1 Analyzer quick reference 11

2 Overview 15

3 Detailed device description 23

4 Conducting a basic Analyzer session 47

5 Using the concurrency feature 63

6 Using advanced features 79

7 Maintenance 87

8 Analyzer specifications 95

9 Accessories 99

Index 107

Explanation of symbols

About this guide

Analyzer quick reference1

Typical values

Performing a lead analysis

Overview2

Device description

Key features

Safety features

Intended use

Package contents

Contraindications

Warnings and precautions

Detailed device description3

Analyzer overview

The display screen

Live rhythm monitor

Lead Analysis screen

Pace/sense LEDs

Changing the pacing mode

Pacing fields

Mode field

Mode transition rules

Filter field

Changing the R-Wave Filter

How to change the R-Wave filter using the Filter field

Pacing parameters

Lead Analysis screen

Analyzer Settings window

Emergency VVI pacing

Parameters

Considerations

Details about Emergency pacing

Analog output of Analyzer signals

Parameters

Non-programmable features

Power loss and loss of host communication

Pacing operation description

Conducting a basic Analyzer session4

Preparing the Analyzer for use

Details on starting the Analyzer session

Analyzer update

Details on selecting the R-Wave filter

How to select the appropriate R-Wave Analyzer filter

Details on lead polarity

Analyzing the lead

Details about measuring lead impedance

Details about determining stimulation thresholds

Details about viewing and printing saved measurements and saving them to diskette

Printing reports

Ending the analyzer session

Details about ending the Analyzer session

Using the concurrency feature5

What is concurrency?

Independent operation of device and analyzer sessions with concurrency

Functionality available in the programmer desktop with concurrency

Concurrency Task Bar controls

How to tell if your device supports concurrency

When you can switch sessions using the task bar

Setting up for an implant

How to set up for an implant

Pacing therapy

Background pacing with the analyzer

Emergency pacing through the analyzer

Printing with concurrency