Operators Manual
68 Pages
Preview
Page 1
OPERATOR’S MANUAL
EMBLEM™ S-ICD REF 3877, 3300
Table of Contents INFORMATION FOR USE ... 1 Trademark Statement. . .. . ... . ... . ... . ... . ... . ... . ... . ... . ... . 1 Description and Use... . ... . ... . ... . ... . ... . ... . ... . ... . ... . 1 Intended Use .. . ... . ... . ... . ... . ... . ... . ... . ... . ... . ... . 1 Intended Audience. ... . ... . ... . ... . ... . ... . ... . ... . ... . ... . 1 Required Expertise and Knowledge .. . ... . ... . ... . ... . ... . ... . ... . 1 Medical Product Operator’s Ordinance ... . ... . ... . ... . ... . ... . ... . 2 List of Acronyms... . ... . ... . ... . ... . ... . ... . ... . ... . ... . 2 Contraindications... . ... . ... . ... . ... . ... . ... . ... . ... . ... . 2 Related Information... . ... . ... . ... . ... . ... . ... . ... . ... . ... . 2 Warnings. ... . ... . ... . ... . ... . ... . ... . ... . ... . ... . ... . 3 S-ICD Precautions . . ... . ... . ... . ... . ... . ... . ... . ... . ... . ... . 5 Adverse Effects . ... . ... . ... . ... . ... . ... . ... . ... . ... . ... . 7 USING THE S-ICD APPLICATION ... 8 S-ICD Application Setup Overview . . .. . ... . ... . ... . ... . ... . ... . ... . 8 Powering the Model 3300 Programmer. ... . ... . ... . ... . ... . ... . ... . 9 Powering the Programmer On and Off. . ... . ... . ... . ... . ... . ... . ... 10 Using the Programmer Touch Screen... . ... . ... . ... . ... . ... . ... 11 S-ICD Application Navigation. . ... . ... . ... . ... . ... . ... . ... . ... 11 S-ICD Application Screen Header . .. . ... . ... . ... . ... . ... . ... . ... 11 S-ICD Application Navigation Bar . .. . ... . ... . ... . ... . ... . ... . ... 11 Configuring the S-ICD Application . . .. . ... . ... . ... . ... . ... . ... . ... 12 Starting the Model 3300 Programmer... . ... . ... . ... . ... . ... . ... 12 Set the Language and Time Zone .. . ... . ... . ... . ... . ... . ... . ... 13 Enable Bluetooth® Communications . ... . ... . ... . ... . ... . ... . ... 14 Start the S-ICD Application . .. . ... . ... . ... . ... . ... . ... . ... . ... 15 Date and Time Format. . ... . ... . ... . ... . ... . ... . ... . ... . ... 17 Set Noise Filter Configuration . ... . ... . ... . ... . ... . ... . ... . ... 18 Printer Selection. . ... . ... . ... . ... . ... . ... . ... . ... . ... . ... 19 Model 3877 S-ICD Application Software Version... . ... . ... . ... . ... . ...20 Bluetooth® Data Export . ... . ... . ... . ... . ... . ... . ... . ... . ...20 Application Modes of Operation ... . ... . ... . ... . ... . ... . ... . ... 22 Online Behavior . . ... . ... . ... . ... . ... . ... . ... . ... . ... . ... 22 Offline Behavior . . ... . ... . ... . ... . ... . ... . ... . ... . ... . ... 22 Stored Patient Sessions. ... . ... . ... . ... . ... . ... . ... . ... . ... 22 Modes of Operation for the Pulse Generator . .. . ... . ... . ... . ... . ... . ... 23 Shelf Mode .. . ... . ... . ... . ... . ... . ... . ... . ... . ... . ... 23 Therapy On Mode ... . ... . ... . ... . ... . ... . ... . ... . ... . ... 23 Therapy Off Mode... . ... . ... . ... . ... . ... . ... . ... . ... . ... 23 MRI Protection Mode .. . ... . ... . ... . ... . ... . ... . ... . ... . ... 23
Connecting and Disconnecting from the S-ICD Pulse Generator . ... . ... . ... . .. 25 Scanning for Pulse Generators. .. . ... . ... . ... . ... . ... . ... . ... . .. 25 Connecting to a Pulse Generator . ... . ... . ... . ... . ... . ... . ... . ..26 Connecting to a Pulse Generator in Shelf Mode.. . ... . ... . ... . ... . ... . ..26 Connecting to an Implanted Pulse Generator . . .. . ... . ... . ... . ... . ... . ..26 Ending a Patient Session .. . ... . ... . ... . ... . ... . ... . ... . ... . ..26 Programming the Pulse Generator at Implant... . ... . ... . ... . ... . ... . ..28 Entering Electrode Information .. . ... . ... . ... . ... . ... . ... . ... . ..29 Creating the Patient Chart . . ... . ... . ... . ... . ... . ... . ... . ... . ..29 Automatic Setup . ... . ... . ... . ... . ... . ... . ... . ... . ... . ..30 Programming Therapy Parameters... . ... . ... . ... . ... . ... . ... . .. 33 Defibrillation Testing ... . ... . ... . ... . ... . ... . ... . ... . ... . .. 35 Performing a Follow-up... . ... . ... . ... . ... . ... . ... . ... . ... . ..38 Sensing Configuration and Automatic Setup... . ... . ... . ... . ... . ... . ..38 Viewing Pulse Generator Status . . ... . ... . ... . ... . ... . ... . ... . ..39 Viewing Stored Episodes .. . ... . ... . ... . ... . ... . ... . ... . ... . ..40 Printing Reports from the S-ICD Application. . ... . ... . ... . ... . ... . ... . ..42 Printing Reports. . ... . ... . ... . ... . ... . ... . ... . ... . ... . ..42 Summary Report . ... . ... . ... . ... . ... . ... . ... . ... . ... . ..43 Captured S-ECG Report . . .. . ... . ... . ... . ... . ... . ... . ... . ... . ..44 Episode Reports. . ... . ... . ... . ... . ... . ... . ... . ... . ... . ..45 Export Patient Data ... . ... . ... . ... . ... . ... . ... . ... . ... . ..45 S-ECG Features . . .. . ... . ... . ... . ... . ... . ... . ... . ... . ... . ..46 S-ECG Rhythm Strip Markers, Indicators, and Discontinuities . . ... . ... . ... . ..46 S-ECG Scale Settings . ... . ... . ... . ... . ... . ... . ... . ... . ... . .. 47 Capture and View S-ECG Strips .. . ... . ... . ... . ... . ... . ... . ... . ..48 View previously-captured S-ECGs. ... . ... . ... . ... . ... . ... . ... . ..49 Utilities Screen . . .. . ... . ... . ... . ... . ... . ... . ... . ... . ... . ..49 Acquire Reference S-ECG .. . ... . ... . ... . ... . ... . ... . ... . ... . ..50 Capture All Sense Vectors . . ... . ... . ... . ... . ... . ... . ... . ... . ..50 Beeper Control .. . ... . ... . ... . ... . ... . ... . ... . ... . ... . .. 51 Manual Setup. . .. . ... . ... . ... . ... . ... . ... . ... . ... . ... . .. 52 SMART Settings . . ... . ... . ... . ... . ... . ... . ... . ... . ... . ..54 AF Monitor. ... . ... . ... . ... . ... . ... . ... . ... . ... . ... . ..56 Additional S-ICD Application Features. . .. . ... . ... . ... . ... . ... . ... . ..56 Rescue Shock . . .. . ... . ... . ... . ... . ... . ... . ... . ... . ... . ..56 Manual Shock . .. . ... . ... . ... . ... . ... . ... . ... . ... . ... . ..58 S-ICD System Magnet Use . . ... . ... . ... . ... . ... . ... . ... . ... . ..58 MAINTENANCE, TROUBLESHOOTING, HANDLING, STANDARDS, AND SPECIFICATIONS ...59 WARRANTY INFORMATION ...59
INFORMATION FOR USE Trademark Statement The following are trademarks of Boston Scientific Corporation or its affiliates: AF Monitor, EMBLEM, ImageReady, LATITUDE, LATITUDE Consult, LATITUDE NXT, Quick Start, ZIP, ZOOM, Heart Connect, ALTRUA, INSIGNIA, and NEXUS. The Bluetooth® word mark and logos are registered trademarks owned byBluetooth SIG, Inc. and any use of such marks is under license. DisplayPort is a trademark of the Video Electronics Standards Association (VESA).
Description and Use The following Operator’s Manuals describe the LATITUDE Programming System for use with S-ICD pulse generators: 1.
LATITUDE™ Programming System Operator’s Manual (Model 3300)
2.
EMBLEM™ S-ICD Application Operator’s Manual (Model 3877)
These manuals are also available online at: www.bostonscientific-elabeling.com. The Model 3300 Programmer is the programming device of the LATITUDE Programming System, which is a portable cardiac rhythm management system designed to be used with specific Boston Scientific systems, i.e., implantable pulse generators (PGs), electrodes, and leads.
Intended Use The LATITUDE Programming System is intended for use in hospital and clinical environments to communicate with Boston Scientific implantable systems. The software in use controls all communication functions for the PG. For detailed software application instructions, refer to the associated product literature for the PG being interrogated.
Intended Audience This literature is intended for use by health care professionals trained or experienced in device implant and/or follow-up procedures.
Required Expertise and Knowledge Users must be thoroughly familiar with electrotherapy of the heart. Only qualified medical specialists having the special knowledge required for the proper use of the device are permitted to use it. Physician Supervision The LATITUDE Programming System may only be operated under the constant supervision of a physician. During a procedure, the patient must be continuously monitored by medical personnel with the aid of a surface ECG monitor.
1
Medical Product Operator’s Ordinance National regulations may require that the user, manufacturer or manufacturer representative perform and document safety checks of the device during installation. They may also require that the manufacturer or its representative provide training to users on the proper use of the device and its accessories. If you do not know the national regulations in your country, please contact your local Boston Scientific representative.
List of Acronyms The following list of acronyms is used throughout this manual. AC
Alternating current
MRI
Magnetic resonance imaging
AF
Atrial Fibrillation
NSR
Normal sinus rhythm
ATP
Anti-tachycardia pacing
RF
Radio Frequency
CRT
Cardiac resynchronization therapy
RFI
Radio Frequency Interference
CPR
Cardiopulmonary resuscitation
RFID
Radio Frequency Identification
ECG
Electrocardiogram
S-ECG
Subcutaneous electrocardiogram
EMI
Electromagnetic interference
S-ICD
Subcutaneous implantable cardioverter defibrillator
EOL
End of life
USB
Universal serial bus
ERI
Elective replacement indicator
VAC
Voltage alternating current
ESD
Electrostatic discharge
VF
Ventricular fibrillation
GUI
Graphic user interface
VT
Ventricular tachycardia
LCD
Liquid crystal display
Contraindications The LATITUDE Programming System is contraindicated for use with any PG other than a Boston Scientific PG. For contraindications for use related to the PG, refer to the associated product literature for the PG being interrogated. The Model 3877 S-ICD application is contraindicated for use with any programming system other than the Boston Scientific Model 3300 LATITUDE Programming System. Unipolar stimulation and impedance-based features are contraindicated for use with the SICD System.
Related Information Before using the S-ICD system, read and follow all instructions, warnings, and precautions provided in this manual, the LATITUDE Programming System Operator’s Manual (Model
2
3300), and in the manuals for the other system components, including the applicable SICD pulse generator, subcutaneous electrode, and electrode implant tools user’s manuals. This manual may contain reference information for pulse generator model numbers that are not currently approved for sale in all geographies. For a complete list of model numbers approved in your geography, consult with your local sales representative. Some model numbers may contain fewer features; for those devices, disregard descriptions of the unavailable features. Descriptions found within this manual apply to all device tiers unless otherwise noted. Refer to the ImageReady™ MR Conditional S-ICD System - MRI Technical Guide (hereafter referred to as the S-ICD MRI Technical Guide) for information about MRI scanning. This manual is also available online at www.bostonscientific-elabeling.com.
WARNINGS Additional warnings specific to the Model 3300 Programmer are described in the LATITUDE Programming System Operator’s Manual, Model 3300. Additional warnings specific to the S-ICD pulse generator are described in the S-ICD Physician Technical Manuals.
S-ICD System Warnings General •
Connector contacts.
! •
Physiological signals.
! •
Use of the Model 3300 Programmer adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
LATITUDE Programming System is MR unsafe.
!
1.
The Programmer is non-sterile and cannot be sterilized. Do not allow the device to enter a sterile zone in an implant environment.
LATITUDE Programming System location.
!
•
Operation of the LATITUDE Programming System with physiological signals that are lower than the minimum detectable amplitude may cause inaccurate results.
LATITUDE Programming System must remain outside sterile field.
! •
Do not simultaneously touch the patient and any accessible LATITUDE Programming System connector or exposed conductor.
The LATITUDE Programming System is MR Unsafe and must remain outside the MRI site Zone III (and higher) as defined by the American College of Radiology Guidance Document for Safe MR Practices1. Under no circumstances should the LATITUDE Programming System be brought into the MRI scanner room, the control room, or the MRI site Zone III or IV areas.
Kanal E, et al., American Journal of Roentgenology 188:1447-74, 2007.
3
•
Backup defibrillation protection.
!
•
Component compatibility.
!
•
Always have external defibrillation equipment and medical personnel skilled in CPR available during implant and follow up testing. If not terminated in a timely fashion, an induced ventricular tachyarrhythmia can result in the patient’s death.
All Boston Scientific S-ICD implantable components are designed for use with the Boston Scientific or Cameron Health S-ICD System only. Connection of any S-ICD System components to a non-compatible component has not been tested and could result in failure to deliver life-saving defibrillation therapy.
Pulse generator interaction.
!
Using multiple pulse generators could cause pulse generator interaction, resulting in patient injury or a lack of therapy delivery. Test each system individually and in combination to help prevent undesirable interactions. Refer to the appropriate S-ICD pulse generator manual for more information.
Clinical Considerations •
Myopotentials.
!
The S-ICD System may sense myopotentials which may result in over/under sensing.
Implantation •
High shocking electrode impedance.
! •
Upper extremity injury.
!
•
High shocking electrode impedance may reduce VT/VF conversion success.
During arrhythmia induction, the induction current and subsequent shock may result in forceful contraction of the pectoralis major muscle which can exert significant acute forces on the glenohumeral joint as well as on the clavicle. This, in conjunction with a tightly restrained arm, may result in injury to the clavicle, shoulder, and arm, including dislocation and fracture.
Avoid shock at implant.
!
Verify the device is in Shelf mode or Therapy Off to prevent the delivery of unwanted shocks to the patient or the person handling the device during the implant procedure.
Device Programming •
4
Sensing adjustment.
! •
Programming for supraventricular tachyarrhythmias (SVTs).
! •
Following any sensing parameter adjustment or any modification of the subcutaneous electrode, always verify appropriate sensing.
Determine if the device and programmed parameters are appropriate for patients with SVTs because SVTs can initiate unwanted device therapy.
Device software update.
!
During a device software update, tachycardia therapy is suspended. Always monitor the patient and have external defibrillation equipment available during interrogation.
Post-Implant •
Beeper volume after MRI.
!
•
Magnet Response with Deep Implant Placement (S-ICD only).
!
•
The Beeper may no longer be usable following an MRI scan. Coming in contact with the strong magnetic field of an MRI scanner may cause a permanent loss of the Beeper volume. This cannot be recovered, even after leaving the MR scan environment and exiting MRI Protection Mode. Before an MRI procedure is performed, a physician and patient should weigh the benefit of the MR procedure against the risk of losing the Beeper. It is strongly recommended that patients are followed on LATITUDE NXT (a remote patient management system) after an MRI scan if they are not already. Otherwise, an in-clinic follow-up schedule of every three months is strongly recommended to monitor device performance.
In patients with an S-ICD pulse generator deep implant placement (greater distance between the magnet and the pulse generator) magnet application may fail to elicit the magnet response. In this case the magnet cannot be used to inhibit therapy.
Magnet Response (S-ICD only).
!
Use caution when placing a magnet over the S-ICD pulse generator because it suspends arrhythmia detection and therapy response. Removing the magnet resumes arrhythmia detection and therapy response.
PRECAUTIONS Additional precautions specific to the Model 3300 Programmer are described in the LATITUDE Programming System Operator's Manual, Model 3300. Additional precautions specific to the S-ICD pulse generator are described in the S-ICD Physician Technical Manuals. •
Implantation •
Operating temperature. Allow the pulse generator to reach an operating temperature range of 25° C - 45° C (77° F - 113° F) before using telemetry
5
communication capabilities, programming, or implanting the pulse generator because temperature extremes may affect initial device function. • •
6
At implant, confirm communication with the PG. Confirm that the Programmer is in communication with the intended S-ICD pulse generator.
Device Programming •
Programming System. Use only the appropriate LATITUDE Programming System equipped with the appropriate software to program specific Boston Scientific PGs.
•
Programmer must remain outside the sterile field. The Programmer is nonsterile and cannot be sterilized. It must remain outside the sterile field.
•
Model 3203 S-ICD Telemetry Wand use. For S-ICD PG telemetry, use only the Model 3203 S-ICD Telemetry Wand with the LATITUDE Programming System.
•
Date and time accuracy. Inability to access a remote time server could lead to discrepancies in the Programmer time. As a backup, contact your Boston Scientific representative to have the time and date set manually.
•
Patient data (S-ICD). Data files for up to fifty (50) patients may be stored on the Programmer and appropriate precautions should be taken to secure the Programmer from unauthorized access. –
Delete all S-ICD patient data from the Programmer by selecting the Purge All Data button on the Stored Patient Sessions screen before shipping the Programmer or at any time when the Programmer leaves your direct control.
–
Only connect to known Bluetooth® devices to reduce the potential of transmitting patient data to inappropriate printers or devices.
•
Stylus use. If you want to use a stylus, ensure that it is a projected capacitance stylus. The use of any other object could damage the touchscreen.
•
USB devices. USB devices connected to the Programmer should be encrypted and controlled to limit the potential introduction of malware.
•
Software. Ensure that you have the latest software versions installed. Refer to the LATITUDE Programming System Operator’s Manual (Model 3300) for information about performing a software update. As a backup, your local Boston Scientific representative can provide software updates using a USB pen drive.
•
Wi-Fi. Wi-Fi connectivity is not permitted in Indonesia due to specific configuration requirements.
•
Magnet handling. Do not place a magnet on the Programmer.
•
Patients hear tones coming from their S-ICD device. Patients should be advised to contact their physician immediately whenever they hear tones coming from their S-ICD device.
•
Conversion testing. Successful VF or VT conversion during arrhythmia conversion testing is no assurance that conversion will occur post-operatively. Be aware that changes in the patient’s condition, drug regimen, and other factors may change the DFT, which may result in nonconversion of the arrhythmia postoperatively. Verify with a conversion test that the patient’s tachyarrhythmias can
be detected and terminated by the pulse generator system if the patient’s status has changed or parameters have been reprogrammed.
•
•
High shock impedance. A reported shock impedance value of greater than 110 ohms from a delivered shock could indicate sub-optimal system placement. Care should be taken to place both the pulse generator and electrode directly on the fascia without underlying adipose tissue. Adipose tissue can add significant impedance to the high voltage shock current pathway.
•
Low shock impedance. A reported shock impedance value of less than 25 ohms from a delivered shock could indicate a problem with the device. The delivered shock may have been compromised, and/or any future therapy from the device may be compromised. If a reported impedance value of less than 25 ohms is observed, correct functioning of the device should be verified.
•
Impact of Disable Beeper button. In the Programmer steps to program and test the Beeper, selecting No, Disable Beeper will disable beeping functionality for alert conditions, when a magnet is placed over the device, and when the SICD application connects to the device.
Environmental and Medical Therapy Hazards •
Electrocautery. Electrocautery may induce ventricular arrhythmias and/or fibrillation and may cause inappropriate shocks and inhibition of post-shock pacing and may produce unexpected behavior in the Programmer display or operation. If electrocautery is medically necessary, maintain a distance of at least 30 cm (12 in) between electrocautery equipment and the Programmer and its associated components. Similarly, maintain this distance between the Programmer and its associated components and the patient during these procedures.
•
Model 3203 S-ICD Telemetry Wand shipped non-sterile. The Model 3203 SICD Telemetry Wand is shipped non-sterile. Remove the wand from all packaging material before use. If the wand is to be used in a sterile field, it must be enclosed in a sterile intraoperative probe cover (Model 3320) during use. Refer to the LATITUDE™ Programming System Operator’s Manual (Model 3300) for cleaning information.
Adverse Effects The following are the possible adverse effects associated with programming the pulse generators described in this manual. •
Asystole
•
Atrial arrhythmia
•
Bradycardia
•
Tachycardia
•
Ventricular arrhythmia
Any serious incident that occurs in relation to this device should be reported to Boston Scientific and the relevant local regulatory authority.
7
USING THE S-ICD APPLICATION S-ICD Application Setup Overview This section describes the wand and power connections to the Model 3300 Programmer and basic navigation of the S-ICD Application.
1
2
3
4
5
6
7
8
[1] Power (on/off) button (light gray) [2-4] USB 2.0 ports (dark gray) [5] USB 3.0 port (blue) [6] Ethernet port (orange) [7] DisplayPort Out (red-orange) [8] DC power connection for Model 6689 power adapter (green)
Figure 1.
Left Side Panel of the Programmer
In Figure 1 Left Side Panel of the Programmer on page 8, callout 8 identifies the DC power connection, and callout 1 identifies the Programmer On/Off power button.
8
5 6 3
2
1
4
A/RV LV
[1] Model 6763 PSA Cable for LV (green) [2] Model 6763 PSA Cable for A/RV (light gray) [3] Model 3154/3153 ECG Cable (dark gray) [4] connection port for future use (brown) [5] Model 3203 S-ICD Telemetry Wand (black) [6] Model 6395 Telemetry Wand (blue)
Figure 2.
Right Side Panel of the Programmer
In Figure 2 Right Side Panel of the Programmer on page 9, callout 5 identifies the Model 3203 S-ICD Telemetry Wand connection.
Powering the Model 3300 Programmer The Model 3300 Programmer is primarily intended to be operated while connected to the AC-powered external power supply, but may also be operated on battery power provided that the internal battery is adequately charged. The Programmer is recharged whenever it is connected to the AC-powered external power supply. When not in use, it is recommended that the Programmer remain connected to the external power supply in order to maintain an adequate battery charge.
NOTE: Refer to the LATITUDE™ Programming System Operator’s Manual (Model 3300) for complete startup and battery charging information. NOTE: Current S-ICD session data may be lost if a 45 minute period of inactivity occurs and the Programmer is not connected to AC power. When the Programmer is powered On and the S-ICD Application is running, the battery status indicator displays in the upper right corner of the screen indicating the approximate charge status of the Programmer battery. See Figure 3 S-ICD Application start up screen with battery status icon on page 10. •
All four bars are illuminated (green) – The battery is 100% charged
•
Three bars are illuminated (green) – The battery is 75% charged
•
Two bars are illuminated (yellow) – The battery is 50% charged
•
One bar is illuminated (red) – The battery is 25% charged
The S-ICD Application displays the following alert screens and text as the Programmer battery power gets progressively lower.
9
•
Programmer Battery Caution Screen - “Programmer Battery ≤ 25% - Battery capacity is at xx%.2 It is recommended you find an AC Power source.”
•
Programmer Battery Warning Screen - ”Programmer Battery ≤ 10% - Battery capacity is at xx%. Plug the Programmer into AC Power immediately to ensure system functionality.”
•
Programmer Battery Critical Screen - “Programmer Battery ≤ 5% - Battery capacity is at xx%. Plug the Programmer into AC Power immediately to ensure system functionality. Programmer will automatically shut off within 60 seconds.”
1
[1] Battery Status (bars visible when on battery power).
Figure 3.
S-ICD Application start up screen with battery status icon
NOTE: The screen images in this manual are representative and may not exactly match your screens.
Powering the Programmer On and Off The Programmer’s power button is located on the left side of the Programmer (see Figure 1 Left Side Panel of the Programmer on page 8). Press the button and release it to power the Programmer On or Off.3
NOTE: To end the S-ICD application, select the Quit button from the S-ICD main application screen (Figure 3 S-ICD Application start up screen with battery status icon on page 10). This returns the user to the Programmer main menu Figure 4 Model 3300 Programmer Main Menu on page 13.
2. 3.
10
“xx” is replaced by the actual battery charge remaining percentage. End the S-ICD session before powering off the Programmer.
NOTE: The Model 3300 Programmer can operate on battery or AC power. Refer to the LATITUDE Programming System Operator’s Manual, Model 3300 for instructions on charging the battery and operating only on battery power.
Using the Programmer Touch Screen The Programmer is equipped with an LCD touch screen. All interaction with the programmer is conducted using the fingers to touch the appropriate areas on the screen. Scroll on-screen lists by sliding a finger up and down the list. An on-screen keyboard is presented whenever text entry is required.
NOTE: Use only fingers or a projected capacitance stylus on the Programmer touch screen.
S-ICD Application Navigation The application's graphical user interface (GUI) facilitates management and control of the S-ICD System. The Navigation Bar and on-screen icons at the top of the screen allow the user to navigate programming software screens. In addition, a continuous subcutaneous electrocardiogram (S-ECG) is displayed along the bottom of the screen during Online (active) communication with the pulse generator.
S-ICD Application Screen Header When the S-ICD Application is Offline (inactive communication), the screen header displays the Programmer battery status indicator. When viewing Offline Stored Sessions, the screen header displays: •
Patient name
•
Therapy On/Off
•
Programmer battery status indicator
When the S-ICD Application is Online (active communication), the screen header displays: •
Therapy On/Off
•
Patient name
•
Patient heart rate
•
Programmer battery and telemetry status indicator
•
Screen title
•
Rescue shock icon
S-ICD Application Navigation Bar The Navigation Bar is the primary method for navigating the Online application screens. The bar is located along the top edge of the application screen and chosen screens appear with their selection icon highlighted. The following table provides a list of the icons and their corresponding descriptions.
11
Table 1. Icon descriptions Icon
!
Shock
Description
User Application
S-ICD Application Main Menu Icon
Allows user to return to the main menu.
Battery & Telemetry Meter
Left side of the meter allows user to view the Programmer’s battery status. The right side of the meter allows viewing of telemetry signal strength
Capture S-ECG
Allows user to capture a live S-ECG.
Details
Opens a window containing detailed information.
Heart Rate Icon
Allows user to view current heart rate.
Rescue Shock Icon
Allows user to administer a rescue shock.
Option Selection Switch
Allows user to select one of two options, e.g. A or B.
Configuring the S-ICD Application Starting the Model 3300 Programmer Power on the Programmer to display the Main Menu.
12
1
2 [1] S-ICD Applications button [2] Utilities button
Figure 4. Model 3300 Programmer Main Menu
Set the Language and Time Zone Before starting the S-ICD Application, the language and time zone are set. These settings are persistent and do not need to be re-entered for subsequent S-ICD programming sessions or uses of the Model 3300 Programmer.
NOTE: The formats for the date (mm/dd/yyyy or dd/mm/yyyy) and the time (12 hour or 24 hour) are set in the S-ICD Application itself. See "Date and Time Format" on page 17. 1.
Set the Language a.
From the Model 3300 Programmer Main Menu, select the Utilities button in the lower left of the screen.
b.
Select the Setup tab.
c.
Select the language bar, then select the desired language. as illustrated in the following figure.
13
Figure 5.
2.
Utilities
Set the Time Zone a.
From the Model 3300 Programmer Main Menu, select the Utilities button in the lower left of the screen.
b.
Select the Date and Time tab.
c.
Select the time zone bar, then select the desired time zone as illustrated in the following figure.
Figure 6. Utilities - Setup time zone
Enable Bluetooth® Communications To use Bluetooth® communications for printing or exporting patient data, it must be enabled using the Utilities menu of the Model 3300 Programmer.
14
NOTE: Printers that are directly connected to the Programmer by a USB cable do not require Bluetooth® communications. NOTE: Exporting patient data using Bluetooth® requires that Bluetooth® communications be enabled. 1.
Select the Utilities tab from the main menu of the Programmer.
2.
From the Utilities menu, select the Bluetooth® tab and then select the Enable Bluetooth check box as illustrated in Figure 7 Utilities menu - Enable Bluetooth® check box selected on page 15.
1
[1] Enable Bluetooth® checkbox selection
Figure 7.
3.
Utilities menu - Enable Bluetooth® check box selected
The Programmer begins a scan of Bluetooth® enabled computers4 within range and lists them in the Unauthorized Computers Nearby column.
These steps enable Bluetooth® communications and allow you to configure a Bluetooth printer and export patient data from within the S-ICD Application. Refer to "Printer Selection" on page 19 to configure a Bluetooth® printer. Refer to "Bluetooth® Data Export" on page 20 to authorize a computer to receive exported patient data using Bluetooth®.
NOTE: Printers can be configured from either the Programmer Utilities tab or from the SICD Printer Setup screen.
Start the S-ICD Application 1.
With the Model 3203 Telemetry Wand connected and the Model 3300 Programmer powered on, select the S-ICD Applications button from the main menu. See Figure 4 Model 3300 Programmer Main Menu on page 13.
2.
When the S-ICD Applications panel displays, select the S-ICD Device Programmer Application icon.
4.
The 3300 Programmer only recognizes Bluetooth® enabled computers and printers.
15
3.
A start Application dialogue displays while the application loads, then the EMBLEM™ S-ICD System start-up screen displays.
NOTE: It can take approximately 30 seconds for the S-ICD Application to load. During this time, the screen displays the Start Application message and hourglass icon followed by a large text display of Boston Scientific. The following figure illustrates the startup sequence. 1
2
3
4
5
Figure 8.
S-ICD Application startup sequence
To configure the S-ICD Application settings: 1.
16
Select the Programmer Settings button on the EMBLEM S-ICD start-up screen (Figure 9 S-ICD programming application start-up screen on page 17) to display the Programmer Settings screen (Figure 10 S-ICD Programmer Settings screen on page 17).
Figure 9. S-ICD programming application start-up screen
Figure 10.
2.
S-ICD Programmer Settings screen
Select the corresponding line to access each setting. The settings that can be configured include: •
Date and Time format
•
Noise Filter Configuration
•
Printer Setup
Date and Time Format NOTE: Before setting the date and time formats, ensure that the Time Zone has been set for the Programmer. See "Set the Language and Time Zone" on page 13. To set the date and time format:
17