Medtronic 2290 Reference Guide
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.
Contents
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
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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.
7
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
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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.
9
About this guide
Analyzer Reference Guide
Analyzer quick reference1
Typical values 12
Performing a lead analysis 13
1
12
Chapter 1
Typical values
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
a
Use of high impedance leads can result in measurements greater than 800 Ω.
a
Analyzer Reference Guide
Analyzer quick reference
■
P-wave
■
R-wave
■
slew rate
Performing a lead analysis
Performing a lead analysis
Setup Page
Necessary equipment:
1.
■
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
page 52
13
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
OR
■
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
2
16
1
Chapter 2
Device description
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
17
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.
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Chapter 2
Contraindications
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.
19
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”
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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.
21
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
22
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
3
24
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3
4
5
6
7
8
1
Chapter 3
Analyzer overview
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.
25
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
26
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
27
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.
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1
2
3
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.
29
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
30
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
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