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
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QTECH™ PROGRAMMER: COMPLIANCE STATEMENTS
Federal Communications Commission (FCC) US
This transmitter is authorized by rule under the Medical Device Radiocommunication Service (in part
95 of the FCC Rules) and must not cause harmful interference to stations operating in the 400.150 -
406.00 MHz band in the Meteorological Aids (i.e., transmitters and receivers used to communicate
weather data), the Meteorological Satellite, or the Earth Exploration Satellite Services and must accept
interference that may be caused by such stations, including interference that may cause undesired
operation. This transmitter shall be used only in accordance with the FCC Rules governing the Medical
Device Radiocommunication Service. Analog and digital voice communications are prohibited.
Although this transmitter has been approved by the Federal Communications Commission, there is no
guarantee that it will not receive interference or that any particular transmission from this transmitter
will be free from interference.
The Bluetooth® module contained within the Model 3200 programmer complies with Title 47, Part 15 of
the FCC rules. Operation is subject to the following two conditions:
• This device may not cause harmful interference, and
• This device must accept any interference received, including interference that may cause
undesired operation.
FCC ID SDYCHI2020
Contains: FCC ID ESCCRM70514
CAUTION: Changes or modications not expressly approved by Cameron Health / Boston Scientic
could void the user’s authority to operate the equipment.
Essential Performance
In order for the Model 3200 Programmer to meet its intended use, it must interrogate and maintain a
communications link with a supported pulse generator as well as being able to appropriately detect
touch screen button presses. Therefore those functions that pertain to communications with the
implanted cardioverter debrillator and detection of touch screen presses are considered essential
performance.
COMPLIANCE STATEMENTS