User's Manual
Table Of Contents
- Preface
- Chapter 1: System Description
- Chapter 2: System Interface
- Chapter 3: Preparing for a New Case
- Chapter 4: System Operation
- Chapter 5: System Settings
- Chapter 6: Review Case Data
- Chapter 7: Cleaning and Maintenance
- Chapter 8: Troubleshooting
- Appendix A: Technical Specifications
- SmartSponge® Flex System Dimensions
- Power Requirements
- Environmental Conditions
- SmartSponge Flex Sponges and Towels
- MRI Information
- EMC Considerations
- Guidance and Manufacturer’s Declaration – Emissions
- All Equipment and Systems
- Guidance and Manufacturer’s Declaration – Immunity
- All Equipment and Systems
- Guidance and Manufacturer’s Declaration – Emissions
- Equipment and Systems that are NOT Life-supporting
- Recommended Separation Distances between portable and mobile RF Communications equipment and the ClearCount SmartSponge Flex Model A04
- Equipment and Systems that are NOT Life-supporting
- Device Label
A-2 Appendix A: Technical Specifications
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Power Requirements
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Power Requirements
Environmental Conditions
SmartSponge Flex Sponges and Towels
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All SmartSponge Sponges and Towels are constructed of 100% cotton.
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ClearCount RFID tags are encapsulated in bio-compatible epoxy.
MRI Information
MR Conditional
Non-clinical testing demonstrated that the ClearCount RFID Tag is MR Conditional. A patient
with a ClearCount RFID tagged item can be scanned safely, immediately after placement under
the following conditions:
Static Magnetic Field
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Static magnetic field of 3-Tesla or less
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Maximum spatial gradient magnetic field of 720-Gauss/cm or less
MRI-Related Heating
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Maximum MR system reported whole-body-averaged specific absorption rate (SAR) of 3-W/kg for 15
minutes of scanning (i.e., per pulse sequence).
In non-clinical testing, the ClearCount RFID tag produced a temperature rise of less than or equal to 3.0
degrees C at a maximum MR system-reported whole body averaged specific absorption rate (SAR) of 3-W/kg
for 15-minutes of MR scanning in a 3-Tesla MR system using a transmit/receive body coil (Excite, Software
G3.0-052B, General Electric Healthcare, Milwaukee, WI).
Artifacts
MR image quality may be compromised if the area of interest is in the exact same area of relatively close to
the position of the ClearCount RFID tag. Therefore, optimization of MR imaging parameters to compensate
for the presence of this implant/device may be necessary.
Attention:
Contact ClearCount Medical Solutions for further information, as needed.
Power supply: 120 - 240 VAC, 50/60 Hz, 60 W
Power consumption: 0.65 Amps at 120 VAC
Outlet requirement: standard, single-phase, grounded three-prong outlet
Power cord length: 20 feet
Internal fuse rating: 3 Amp, fast acting on Neutral (N) and Line (L)
Operating Temperatures:
Ambient temperature: 50°F to 104°F (+10°C to +40°C)
Relative humidity 30 to 75%
Atmospheric pressure 700 to 1060 hPa
Transport and Storage Temperatures:
Ambient temperature: -40°F to 158°F (-40°C to +70°C)
Relative humidity: 10 to 95% noncondensing
Atmospheric pressure: 500 to 1060 hPa