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
71
QTECH™ PROGRAMMER: COMPLIANCE STATEMENTS
EMI/RFI
This equipment has been tested and found to comply with the applicable limits for medical devices, IEC
60601-1-2:2007 or Active Implantable Medical Device Directive 90/385/EEC.
Although this testing shows the device to provide reasonable protection against harmful interference
in a typical medical installation, there is no guarantee that interference will not occur in a particular
installation. If the device does cause harmful interference the user is encouraged to try and correct the
interference by the following measures:
• Reorient or relocate the device
• Increase the separation between the devices
• Connect the equipment to an outlet on a dierent circuit
• Contact your Cameron Health/Boston Scientic representative or customer service.