User's Manual
Table Of Contents
- general description
- Description
- Indications for Use
- Intended Use
- Contraindications
- Programmer Warnings and Cautions
- General
- Electrostatic Discharge (ESD)
- S-ICD System Warnings and Cautions
- General
- Use of Other Medical Therapies/Diagnostic Procedures
- Electromagnetic Interference (EMI) Outside the Hospital Environment
- S-ICD System Clinical Investigation
- Potential Adverse Events
- Setup of the Q-TECH Programmer
- Packaging
- Programmer Controls and Connections
- Charging the Programmer
- Using the Q-TECH Programmer
- Turning the Programmer On
- Changing the Programmer Volume Level
- Placing the Programmer in Suspend Mode
- Turning the Programmer Off
- Using the Programmer Touch Screen
- Using the Wand
- Navigation
- Screen Header
- Navigation Bar
- Restarting the Programmer
- Configuring the Q-TECH Programmer
- Configuring Programmer Settings
- Date and Time Format
- Time Zone
- Language Preference
- Printer Selection
- Programmer Software Version
- Modes of Operation for the Q-TECH Programmer
- Online Behavior
- Offline Behavior
- Modes of Operation for the SQ-RX Device
- Shelf Mode
- Therapy On Mode
- Therapy Off Mode
- Connecting and Disconnecting from the SQ-RX Device
- Scanning For SQ-RX Devices
- Connecting to the SQ-RX Device
- Connecting to an SQ-RX Device in Shelf Mode:
- Ending a Patient Session
- Programming the SQ-RX Device at Implant
- Entering Electrode Information
- Creating the Patient Chart
- Automatic Setup
- Programming Therapy Parameters
- Defibrillation Testing
- Performing an SQ-RX Follow-up
- Sensing Configuration and Automatic Setup
- Viewing SQ-RX Device Status
- Viewing Stored Episodes
- Printing Reports from the Programmer
- Printing Reports
- Summary Report
- Captured S-ECG Report
- Episodes Report
- S-ECG Features
- S-ECG Rhythm Strip Markers
- S-ECG Scale Settings
- Capture and View S-ECG Strips
- Utilities Menu
- Acquire Reference S-ECG
- Capture All Sense Vectors
- Beeper Control
- Manual Setup
- Smart Charge
- Additional Programmer Functions
- Rescue Shock
- Manual shock
- S-ICD System Magnet Model 4520
- Charging the Programmer
- Cleaning the Programmer
- Service
- Maintenance Check
- Safety Measurements
- Programmer End of Life
- Inability to Print
- No Printer Available
- Touch Screen Inactive while Connected to AC Power
- Loss of Communication with Printer
- Inability to Communicate With the SQ-RX Device
- Federal Communications Commission (FCC) US
- Essential Performance
- EMI/RFI
- Declarations tables
- Table 3: Declaration Electromagnetic Emission
- Table 4: Declaration Electromagnetic Immunity Part 1
- Table 5: Declaration Electromagnetic Immunity Part 2
- Table 6: Recommended Separation Distances
- Table 7: EMI/RFI Information: Programmer–to–pulse generator
- Table 8: EMI/RFI Information: Programmer–to–printer (Bluetooth®)
- Specifications
- Table 9: Product Guidelines
- Table 10: Specifications
- Table 11: Nominal Specifications
- Definition of package label symbols
- Table 12: Packaging Symbols: Q-TECH Programmer
- Table 13: Packaging Symbols: Q-TECH Programmer Wand
- Warranty
- Limited Warranty
13
QTECH™ PROGRAMMER: OPERATION
When telemetry loss occurs, the display screen will turn yellow and a message will appear with the
text “Communication Loss” to alert the user. Reposition the wand to establish communication. The
programmer will display a screen informing the user if the SQ-RX device is found and programming
can continue.
Note: If communication cannot be reestablished, the session should be ended
and restarted by scanning for the SQ-RX device.
Navigation
The programmer’s graphic 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 SQ-RX
device.
Screen Header
When the programmer is Oine (inactive communication), the screen header displays the Battery
Status Indicator.
When viewing Oine Stored Sessions, the screen header displays:
• Patient name
• Therapy On/O
• Battery status indicator
When the programmer is online (active communication), the screen header displays:
• Therapy On/O
• Patient name
• Patient heart rate
• Programmer Battery and Telemetry status indicator
• Screen title
• Rescue shock icon