Medtronic 8042B Reference Guide

INSYNC®III
Device Model 8042
Vision
Programmer Software Model 9981
Device Programming Guide
Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician (or properly licensed practitioner).
InSync® III Model 8042 Device Programming Guide
A guide to using the 9790 Series Programmer with the InSync III Model 8042 device
Refer to the InSync III Model 8042 Device Reference Guide for more information.
The following terms are trademarks of Medtronic. Auto-PVARP, InSync Significant Events, and Vision
, Marker Channel, Medtronic, Medtronic.Vision, Quick Look,
Medtronic, Inc. 2000
All Rights Reserved

How to Use This Guide

Information is Contained in Two Guides

Product information about the InSync III device and use of the 9790 series programmer is presented in two separate guides:
The InSync® III Model 8042 Device Programming Guide provides instructions on how to use the programmer and the 9981 software with the InSync III device model.
The InSync® III Model 8042 Device Reference Guide is a supplementary guide that provides detailed information about the InSync III device model.
Note: A small technical manual, which contains information about implantation, is also supplied with each InSync III device.

About this Guide

How to Use This Guide
This programming guide provides the following information.
How to setup and configure the programmer and access on-line help.
How to start a patient session, use the various follow-up features during the session, and properly end the session.
How to view and print the patient’s ECG and EGM waveform traces.
How to configure the device to collect diagnostic data and how to retrieve and view this information.
How to measure stimulation thresholds and sensing levels.
How to program parameter values and verify rate response parameters settings.
InSync® III Model 8042 Device Programming Guide iii
How to Use This Guide

About the Device Reference Guide

The reference guide provides the following information, which includes operation of the various InSync III device functions.
The pacing modes, rate response options, special therapy features, telemetry types, and data collection options. In some cases, guidelines are given on how to configure device operation.
Parameter and data collection capabilities, longevity projections, and mechanical and electrical specifications.
Troubleshooting information for electrical and hemodynamic problems.
General warning and cautions and potential interference sources.
iv InSync® III Model 8042 Device Programming Guide

Table of Contents

1. Programmer Basics
Tab l e o f Co n te nt s
How to Use This Guide iii
Information is Contained in Two Guides iii About this Guide iii About the Device Reference Guide iv
Setting Up the 9790 Programmer 1-2
Programmer Setup Check List 1-2
Connecting an External Monitor/Recorder 1-4 Connecting the Programmer to Skin Electrodes 1-6 Positioning and Using the Programming Head 1-7
When to Position the Programming Head 1-7
Effect of the Programming Head on Operation of the
Implanted Device 1-9
Observing Magnet Mode Operation 1-10
Alternative PROGRAM and INTERROGATE Buttons 1-
10
Automatic Interrogation at the
Start of a Session 1-11 About the Display Screen 1-12
Features and Conventions of the Display Screen 1-12
Using the On-Screen Keyboard 1-17
Audible Tones 1-19 Programming Emergency Parameters 1-20 Recording an ECG Strip 1-21
About the ECG Recording 1-22 Using the On-line Help Feature 1-24
Entering the Help System 1-25
Using the Links in Help 1-26
Exiting the Help System 1-27
Searching for Information in Help 1-27
2. Conducting a Patient Session
Important Reminders About Software Features for the InSync III Device 2-2
InSync® III Model 8042 Device Programming Guide v
Tab le o f Con te nt s
Features of the Programmer Software 2-2 Automated Monitoring and Collection of Patient
Diagnostic Data 2-3
Starting a Patient Session 2-4
The Starting Point of a Patient Session 2-4 The Tool Palette Between Sessions 2-5 About Automatic Interrogation 2-6 Initial Interrogation Report 2-7 Procedure for Starting a Patient Session 2-7
Proceeding with Session Tasks 2-10
The First Task Screen 2-10 Selecting Another Task or Function 2-10 Consider Using Checklist 2-10
Verifying or Changing Session Preferences 2-12 Interrogating the Implanted Device 2-15 Taking a Quick Look at Device Operation 2-16
The Quick Look Screen 2-16
Viewing Data on the Quick Look Screen 2-17 Viewing Battery and Lead Measurements 2-20
Battery and Lead Measurements Screen 2-20
Device Battery and Lead Measurements 2-21
Updating the Displayed Data 2-22 Checking the Present Parameter Settings 2-23
The Therapy Parameters Screen 2-23 Viewing Patient Information Stored in the Device 2-24 Recording an ECG Strip of Magnet Operation 2-25
The Magnet Test Setup Screen 2-25
Procedure for Conducting a Magnet Test 2-26
Collecting an ECG Strip 2-27
About the Collected ECG Strips 2-27 Checking the Patient’s Underlying Rhythm 2-28
The Underlying Rhythm Test Screen 2-28
Procedure for Checking the Patient’s Underlying
Rhythm 2-29
Collected ECG Strips 2-30 Printing Reports 2-31
Using the Print Button 2-31
vi InSync® III Model 8042 Device Programming Guide
Tab l e o f Co n te nt s
Printing From the Available Reports Window 2-32 Printing Reports Held in the Print Queue 2-33
Ending a Patient Session 2-34
Saving a Session on Diskette 2-35 Options for Clearing Device Data 2-37
3. Streamlining Follow-up with Checklist
About the Checklist Feature 3-2 Using Checklist 3-3 Creating a Custom Checklist 3-4
Selecting the Create/Edit Window 3-4 Choosing a Source for Copying 3-5 Building the Custom Checklist 3-6 Saving the Custom Checklist 3-7
4. Viewing the Patient’s ECG and EGM Traces
Viewing the ECG and Other Rhythm Waveforms 4-2
Expanding the Live Rhythm Monitor Window 4-3 About the Waveform Traces 4-4
Adjusting and Configuring the Display 4-7
Adjusting Waveform Size 4-9 Selecting a Trace Source 4-9 Color Coding the Waveform Traces 4-11 Selecting a Different Sweep Speed 4-11 Programming a Different Telemetry Mode 4-12 Selecting the ECG Filter 4-13 Enabling Artifact Enhancement 4-14 Arranging the Waveforms 4-14
Freezing and Analyzing a Waveform Strip 4-16
Using the On-Screen Calipers 4-17 Adjusting the Frozen Traces 4-18 Saving a Frozen Waveform Strip 4-19 Printing the Frozen Strip 4-19
Recalling and Viewing Waveform Strips 4-20
5. Collecting Diagnostic Data
Automatic Diagnostic Data Collection 5-2
Types of Data Displays 5-2
InSync® III Model 8042 Device Programming Guide vii
Tab le o f Con te nt s
Important Points About Using Diagnostic
Data Collection 5-3 Viewing the Collected Data 5-6
Viewing Procedure 5-6
Viewing Tools 5-8 About the Diagnostic Data Displays 5-9
Heart Rate Histogram 5-9
AV Conduction Histogram 5-12
High Rate Episodes 5-13
Ventricular Rate Histogram During Atrial High Rate 5-18
Ventricular Sensing Episodes 5-20
Chronic Lead Trends 5-22
Atrial High Rate Trend 5-23
Night Heart Rate Trend 5-24
Heart Rate Variability (HRV) Trend 5-26
Patient Activity Trend 5-28 Programming Data Collection Options 5-30
Programming Procedure 5-30
Setting Up Histograms 5-31
Setting Up High Rate Episodes 5-31
Setting Up Ventricular Sensing Episodes 5-35 Clearing Data From the Device 5-36
About the Clear Data Window 5-36
6. Evaluating Parameter Settings
Measuring Stimulation Thresholds 6-2
The Threshold Test Setup Screen 6-2
Setting Up a Threshold Measurement Test 6-3
Executing a Strength-Duration Threshold Test 6-6
Executing an Auto Decrement (Amplitude or Pulse Width)
Threshold Test 6-13
Conducting a Manual Threshold Test 6-15 Determining a Sensitivity Setting 6-18
The Sensing Test Setup Screen 6-18
Checking the Patient’s Intrinsic Rate 6-19
Executing an Automatic Sensing Test 6-19
Automatic Sensing Test Results 6-22
viii InSync® III Model 8042 Device Programming Guide
Tab l e o f Co n te nt s
Executing a Manual Sensing Test 6-23
Using Temporary Programming to Evaluate Parameter Settings 6-26
The Te mpo r ary Te st Se tup S c reen 6-2 6 Procedure for Conducting a
Temp o rar y Test 6-2 7 Programming a High Temporary Pacing Rate 6-29
7. Programming Device Parameters
Programming Parameters 7-2
Selecting the Therapy Parameters Screen 7-2 Programming, Printing, and Clearing Parameter
Va lu es 7- 3 Parameter Restrictions 7-4 How to Program Parameters 7-6 How to Program Subordinate Parameters 7-8 Resetting an ERI or Electrical Reset 7-11
Saving/Retrieving a Set of Parameter Values 7-14
Saving a Set of Parameter Values 7-15 Retrieving a Saved or Nominal Set of Parameter Values 7-
16
8. Rate Response Setup
Using Exercise Test to Verify Rate Response 8-2
Overview of the Exercise Test 8-2 Selecting the Exercise Test 8-3 Starting the Exercise Test 8-3 Evaluating the Results of the Exercise Test 8-5 Adjusting Rate Response 8-6
9. Using the EP Studies Function
About the EP Studies Function 9-2
Intended Use 9-2 General Warning 9-2 Precautions and Considerations 9-2 Protocol Options 9-5 Using Ventricular (VOO) Backup Pacing 9-7
Starting the EP Studies Function 9-8
InSync® III Model 8042 Device Programming Guide ix
Tab le o f Con te nt s
Pacing Mode Restrictions 9-8
Device Operating-Status Restrictions 9-8
Positioning the Programming Head 9-8
Start-up Procedure 9-9
Before You Proceed 9-11 Setting Up and Executing a PES Protocol 9-13
Setting Up a PES Protocol 9-13
Executing the PES Protocol 9-16 Setting Up and Executing a Burst Protocol 9-17
Setting Up a Burst Protocol 9-17
Executing the Burst Protocol 9-19
Setting Up and Executing a VOO Burst 9-20 PES Parameter Definitions and Values 9-22
PES Parameter Definitions 9-22
PES Parameter Values 9-24 Burst Parameter Definitions and Values 9-25
Burst Parameter Definitions 9-25
Burst Parameter Values 9-26
10. Miscellaneous Setup Options - Programmer and Device
Selecting System Operating Preferences 10-2 Adjusting Programmer Time and Date 10-4 Improving the Detection of Pacing Artifacts 10-5 Checking the Software Version 10-6 Starting the Demonstrations Option 10-7 Programming Patient Data into Device Memory 10-8 Connecting an External Printer 10-10
Printer Compatibility 10-10
Materials You Will Need 10-12
Connecting the Printer 10-13
A. Appendix: Parameter Values and Restrictions
Programmable Modes and Parameters A-2 Automatic Diagnostic Setup Parameters A-8 Programming Restrictions A-10
I. Index
x InSync® III Model 8042 Device Programming Guide
Programmer Basics
This chapter provides an overview of setting up the programmer and covers information you should be familiar with before you begin a patient session.
This information includes such things as using the programming head and stylus, programming Emergency parameters, and recording an ECG strip. Sections include an introduction to features of the display screen and use of the on-line Help system.
1
1
Setting Up the 9790 Programmer 1-2
For more detailed information on setting up your programmer, refer to Programmer Description and Setup, a guide supplied with your 9790 series programmer.
InSync® III Model 8042 Device Programming Guide 1-1
Connecting the Programmer to Skin Electrodes 1-6
Positioning and Using the Programming Head 1-7
About the Display Screen 1-12
Programming Emergency Parameters 1-20
Recording an ECG Strip 1-21
Using the On-line Help Feature 1-24
Programmer Basics

Setting Up the 9790 Programmer

Setting Up the 9790 Programmer
The following topics summarize the basic steps for setting up your 9790 series programmer. For more complete information on setting up your programmer, refer to the guide, Programmer Description and Setup, supplied with your programmer.

Programmer Setup Check List

Verify that the components illustrated below are properly connected to the programmer.
Selector Pen
(Stylus)
disconnect the stylus.
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Note: Do not
ECG Cable
Programming Head
Figure 1-1. The Programmer
Setting Up the 9790 Programmer
Figure 1-2. Power Cord
Programmer Basics
Figure 1-3. Programming Head
Figure 1-4. ECG Cable
InSync® III Model 8042 Device Programming Guide 1-3
Programmer Basics
Setting Up the 9790 Programmer

Connecting an External Monitor/Recorder

To connect an external monitor or recorder to your programmer, you need the optional adaptor shown below. Connect the adaptor to the analog output port on the right side of the programmer.
w
Warning: Peripheral equipment connected to the 9790 programmer must be certified according to the applicable IEC standards (IEC 950 for data processing equipment and IEC 601-1 for medical equipment). The system formed by connecting peripheral equipment to the 9790 programmer must comply with IEC 601-1-1 for medical electrical systems. It is the responsibility of the person who connects the peripheral equipment to comply with IEC standards. It is the responsibility of the user to keep peripheral equipment that is certified to IEC 950 at least two meters away from the patient. Contact the peripheral equipment manufacturer for information about IEC certification.
Calibrate Button
Connecting Optional Adaptor to the Analog
Output Port on the Programmer.
Connector Type: BNC
Output Signal: ± 1Volt or ± 5 mV (switchable)
Signal Output Adaptor
A
± 1V ± 5mV
Adaptor Output Signals (after model selection):
A - Patient’s ECG B - Telemetered EGM C - Telemetered EGM D - Marker Channel Telemetry
BCD
Figure 1-5. Connecting the Optional External Adaptor
1-4 InSync® III Model 8042 Device Programming Guide
Programmer Basics
Setting Up the 9790 Programmer
Using the Calibrate Button
Selecting the Calibrate button located next to the analog output port adds a reference signal (as shown in Figure 1-6 and Figure 1-7) to the trace of Marker Channel and EGM telemetry.
The Marker Channel signal shows the relative marker amplitudes, which are not annotated with character codes on an external device. The EGM calibration signal acts as a voltage reference for the displayed EGM.
Atrial Pace (AP)
Atrial Sense (AS)
Atrial Refractory Sense (AR)
Vent. Refractory Sense (VR)
Vent. Sense (VS)
or Biventricular Pace (BV)
Vent. Pace (VP)
Figure 1-6. Marker Channel Signals
5 mV
1 mV
Figure 1-7. EGM Calibration Signals
InSync® III Model 8042 Device Programming Guide 1-5
Programmer Basics

Connecting the Programmer to Skin Electrodes

Connecting the Programmer to Skin Electrodes
At the start of a patient session, the programmer must be connected to skin electrodes on the patient. The ECG display and measurement functions will not operate without detection of the surface ECG signal.
Use an electrode lead to connect each skin electrode to the appropriate port on the ECG cable. Typical electrode placement is shown below. Use standard procedures for attaching disposable skin electrodes to the patient.
RA (R)
RL (N)
Figure 1-8. Connecting the Programmer to Skin Electrodes
Refer to the guide, Programmer Description and Setup, supplied with your 9790 programmer for more details on this procedure.
LA (L)
C (C)
LL (F)
( ) = IEC Coding
1-6 InSync® III Model 8042 Device Programming Guide
Programmer Basics

Positioning and Using the Programming Head

Positioning and Using the Programming Head
In many of the procedures described in the following chapters, you will be directed to position the programming head over the patient’s implanted device.

When to Position the Programming Head

You must position the programming head over the patient’s implanted device whenever a procedure initiates communication between the programmer and the implanted device. Examples are:
At the start of a patient session when you select the [
Auto-Identify] or [Start] button. The programmer
automatically initiates an interrogation that takes a number of seconds to complete.
Prior to executing any command that results in a telemetry or programming transmission.
To view or record Marker Channel or EGM telemetry.
Caution: Do not position the programming head over an implanted device during electrocautery or defibrillation procedures.
InSync® III Model 8042 Device Programming Guide 1-7
Programmer Basics
Positioning and Using the Programming Head
How to Position the Programming Head
The programming head must be properly positioned as described below. An incorrectly positioned programming head can result in the failure of a transmitted command and the loss of telemetry.
1. Hold the programming head directly against the patient’s
skin with the face of the programming head parallel to the implanted device.
Figure 1-9. Positioning the Programming Head
2. Position the programming head so that the amber light in
the light array goes out and one or more of the green lights come on. Move the head a little in each direction to find the position that lights the greatest number of green lights. This is the optimum position.
Light Array
Figure 1-10. Light Array Indicator
1-8 InSync® III Model 8042 Device Programming Guide
Green
Amber/Green
Programmer Basics
Positioning and Using the Programming Head

Effect of the Programming Head on Operation of the Implanted Device

If model selection and application (software) loading are complete, positioning the programming head over an implanted InSync III device does not put the device in the magnet mode of operation, as is the case with previous device models. The programmer automatically sends a Cancel Magnet command to the implanted device, which causes it to continue to operate as programmed.
An exception to this operation can occur if the programming head does not establish a telemetry link with the implanted device (because of strong electrical interference or because the programming head is improperly positioned). In such cases, positioning the programming head would result in magnet mode operation until a telemetry link is established. You can easily verify the present pacing mode by observing the Status Line at the top of the screen.
The present pacing mode shows in the status bar at
the top of the screen.
Operation of the implanted device returns to its programmed state about 2 seconds after you remove the programming head from its position over the device.
InSync® III Model 8042 Device Programming Guide 1-9
Programmer Basics
Positioning and Using the Programming Head

Observing Magnet Mode Operation

To observe Magnet mode operation during a patient session, you must conduct the Magnet test described in Chapter 2. Initiating the Magnet test results in a Threshold Margin Test (TMT) and causes the implanted device to operate in the Magnet mode.
Note: Between patient sessions before you select the device model, positioning the programming head over the implanted device will result in magnet mode operation.
Alternative PROGRAM and
INTERROGATE Buttons
To initiate the Program and Interrogate commands, you have the option to use the on-screen [ the Program [ head.
Program] and [Interrogate] buttons or
P] and Interrogate [I] buttons on the programming
Light Array
[Interrogate] Button
Figure 1-11. Alternative Program and Interrogate
Programming Head Buttons
Note: The [P] or [I] button on the programming head is active only when its counterpart is displayed as an active button on the display screen.
1-10 InSync® III Model 8042 Device Programming Guide
[Program] Button
Programmer Basics
Positioning and Using the Programming Head

Automatic Interrogation at the Start of a Session

At the start of a session when you select [Start] or [Auto Identify], the programmer automatically interrogates the patient’s implanted device. For this process, you must position the programming head and hold it steady in place until the interrogation is complete.
At the bottom center of the screen, an indicator shows the progress of the interrogation. Because this interrogation retrieves parameter information and a portion of the diagnostic data stored in the implanted device, the process may take about one minute.
InSync® III Model 8042 Device Programming Guide 1-11
Programmer Basics

About the Display Screen

About the Display Screen
The programmer display screen is an interactive device that not only displays information in the form of both text and graphics, but functions as a control panel by displaying buttons and menu options that you can select using the stylus.
Features and Conventions of the Display Screen
This section describes the features and conventions of the display screen. The Therapy Parameters screen below shows the main elements of the typical screen.
Status Bar
Live Rhythm
Monitor Window
Task area
Command Bar
Active Field Button Tool Palette
Figure 1-12. Main Elements of a Display Screen Example
1-12 InSync® III Model 8042 Device Programming Guide
Status Bar
Programmer Basics
About the Display Screen
The Status Bar
The status bar at the top of the screen shows:
The present pacing mode.
When any one of a number of test conditions is occurring.
The device model.
The Live Rhythm Monitor Window
This window is a partial view of the full-screen display of ECG, Marker Channel, and telemetered EGM waveform traces. You can expand this window to its full size by selecting the small square button in the upper-right corner of the window or by selecting the [
Adjust...] button.
Live Rhythm
Monitor Window
Heart rate and rate interval show if the programming head is positioned over the implanted device.
Annotations above the waveform trace show the point of programmed parameter changes.
The wavefor m trace or t races t hat show i n this win dow depen d on the selected task screen and how traces have been arranged in the full-screen view. Refer to “Viewing the ECG and Other Rhythm Waveforms” on page 4-2 for information about the live rhythm monitor.
InSync® III Model 8042 Device Programming Guide 1-13
Programmer Basics
About the Display Screen
The Command Bar
The bar at the bottom of the screen always shows the command buttons for programming “emergency” parameters settings, interrogating the implanted device, and ending the patient session.
For complete information on these functions, see “Programming Emergency Parameters” on page 1-20, “Interrogating the Implanted Device” on page 2-15, and “Ending a Patient Session” on page 2-34.
The Task Area
The portion of screen between the live rhythm monitor window at the top and the command bar at the bottom changes according to the task or function you select. The example in Figure 1-12 shows the Therapy Parameters screen for programming device parameter settings. This task area would appear much different if you selected, for example, the Threshold Test Setup screen.
Active Fields
Unshaded areas, or boxes, appearing in the task area are “active fields” that respond to the stylus.
Active fields show as
unshaded areas on
1-14 InSync® III Model 8042 Device Programming Guide
the screen.
Selecting a value, word, name, or phrase that appears in an active field opens a menu or window of alternative options for whatever is represented in that field.
Selecting an active field
opens a menu or window
of alternative options, or
in some cases, an
on-screen keyboard.
Programmer Basics
About the Display Screen
For example, touching the mode value “DDD” in the Mode field with the tip of the stylus opens a window of mode options. Selecting any one of these options replaces the original DDD value with the selected one, which becomes a “pending” value.
Selecting some fields (those with terms ending in an ellipsis, such as “Rate Response...”) open a window displaying additional fields. Some fields that require entry of information, such as patient data, open an on-screen keyboard. How to use this keyboard is described later in this section.
Buttons having a less
distinct shaded label
are not presently active.
Buttons
Buttons like those shown below let you operate the programmer using the stylus. You can “press” a button by touching it with the tip of the stylus.
Buttons may directly execute a command, such as the [ button, or they may open a window that prompts another action. Usually such buttons have a label ending with an ellipsis, such as the [
Save...] or [Get...] buttons shown above.
InSync® III Model 8042 Device Programming Guide 1-15
Program]
Programmer Basics
About the Display Screen
Buttons
Icons
A procedure may instruct you to “press and hold” a button. In such cases you should touch the tip of the stylus to the button and continue to maintain pressure against the button until it is time to “release” the button.
The Tool Palette
The collection of buttons and icons along the edge of the screen is referred to as the “tool palette.” These are the controls you will use to choose the task or function screen you want displayed. Once you have started a patient session, the tool palette is always displayed, making it quick and easy to move to the desired task or function.
Each of the icons acts like a button. To select an icon, touch the icon with the stylus. The “<” symbol adjacent to three of the icons indicates that selecting one of these icons opens a menu of related options. The icons without the < symbol directly open a task screen.
Refer to Table 2-2 on page 2-11 for a brief explanation of the purpose of each button and icon in the tool palette.
Note: If the programmer is operating in the Demo mode, the Session icon is replaced with the Demo icon.
1-16 InSync® III Model 8042 Device Programming Guide
Programmer Basics
About the Display Screen

Using the On-Screen Keyboard

Certain fields on the screen allow you to enter data, such as the patient’s name or chart number. Selecting such a field automatically displays the on-screen keyboard shown below. By touching the letter or character buttons with the stylus, you can use this display feature like an actual keyboard.
Text Entry Window
Space Bar
Figure 1-13. Keyboard Screen
Cursor
Position Keys
The function of the on-screen keyboard buttons are very similar to the keys on a computer keyboard or typewriter (see “Keyboard Buttons” on page 1-18).
InSync® III Model 8042 Device Programming Guide 1-17
Programmer Basics
About the Display Screen
Tab le 1-1. Keyboard Buttons
Button or Feature Function
Text Entry Window
(See Figure 1-13)
Shows the text as you enter it using the keyboard. You can enter only as many characters as can fit in the selected field.
Clears all characters from the text entry window.
Closes the Keyboard screen without changing the selected field.
Deletes the character to the left of the cursor in the text entry window.
Not intended for use.
Locks all characters into upper case until the [Caps] key is selected again. While the [Caps] key is down, the [Shift] and [Shift Lock] keys operate as described below except that characters will shift to lower case.
Shifts all of the characters into upper case and replaces the top row of numbers with commonly used symbols. This shift cancels automatically after you select a character or symbol.
Locks all of the characters into upper case and replaces the top row of numbers with commonly used symbols. Press this key again to return to number keys and lower case.
Shifts the keyboard to a limited set of characters. Selecting a character or symbol cancels [Alt] key.
Space Bar
(See Figure 1-13)
Inserts a blank space.
Moves the cursor one space to the left or the right.
Closes the Keyboard screen and enters the text in the text entry window into the selected field.
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