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
72
QTECH™ PROGRAMMER: DECLARATIONS TABLES
Table 4: Declaration Electromagnetic Immunity Part 1
Table 3: Declaration Electromagnetic Emission
The Q-TECH Model 3200 programmer is intended for use in the electromagnetic environment specied below. The customer or the user of the Q-TECH
Model 3200 should assure that it is used in such an environment.
Emissions Test Compliance Electromagnetic Environment Guidance
RF Emissions CISPR 11 Group 1 The Q-TECH Model 3200 programmer uses RF energy only for its internal
function. Therefore, its RF emissions are very low and are not likely to cause
any interference in nearby electronic equipment.
RF Emissions CISPR 11 Class A The Q-TECH Model 3200 programmer is suitable for use in all establishments
other than domestic and those directly connected to the public low-voltage
power supply network that supplies buildings used for domestic purposes.
Harmonic Emissions IEC 61000-3-2 Class A
Voltage Fluctuations/Flicker Emissions IEC 61000-3-3 Complies
The Q-TECH Model 3200 programmer is intended for use in the electromagnetic environment specied below. The customer or the user of the Q-TECH Model 3200
should assure that it is used in such an environment.
Immunity Test IEC 60601
Test Level
Compliance Level Electromagnetic Environment
Guidance
Electrostatic Discharge
(ESD)
IEC 61000-4-2
± 6 kV contact
± 8 kV air
± 6 kV contact
± 8 kV air
Floors should be wood, concrete, or
ceramic tile. If oors are covered
with synthetic material, then the
relative humidity should be at least
30%.
Electrical Fast
Transient/Burst
IEC 61000-4-4
± 2 kV for power supply lines
± 1 kV for input/output lines
± 2 kV for power supply lines
± 1 kV for input/output lines
Mains power quality should be that
of a typical commercial or hospital
environment.
Surge
IEC 61000-4-5
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
Mains power quality should be that of a
typical commercial or hospital environment.
Voltage Dips, Short
interruptions, and voltage
variations on power
supply input lines
IEC 61000-4-11
<5% U
T
(>95% dip in U
T
) for 0.5 cycles
40% U
T
(60% dip in U
T
) for 5 cycles
70% U
T
30% dip in U
T
) or 25 cycles
<5% U
T
(>95% dip in U
T
) for 5 sec
<5% U
T
(>95% dip in U
T
) for 0.5 cycles
40% U
T
(60% dip in U
T
) for 5 cycles
70% U
T
(30% dip in U
T
) for 25 cycles
<5% U
T
(>95% dip in U
T
) for 5 sec
Mains power quality should be that of a
typical commercial or hospital environment.
If the user of the Q-TECH Model 3200
programmer requires continued operation
during power mains interruptions, it is
recommended that the Q-TECH Model
3200 programmer be powered from an
uninterruptible power supply or a battery.
Power Frequency (50/60
Hz) Magnetic Fields
IEC 61000-4-8
3 A/m 3 A/m Power frequency magnetic elds should
be at levels characteristic of a typical
location in a typical commercial or hospital
environment.
NOTE: U
T
is the a.c. mains voltage prior to application of the test level.