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Table 5. Recommended separation distances between portable and mobile RF communications equipment
and the Visual-ICE Cryoablation System
Recommended separation distances between portable and mobile RF communications equipment and
the Visual-ICE Cryoablation System
The Visual-ICE Cryoablation System is intended for use in an electromagnetic environment in which radiated
RF disturbances are controlled� The customer or the user of the Visual-ICE Cryoablation System can help
prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the Visual-ICE Cryoablation System as recommended below,
according to the maximum output power of the communications equipment�
Rated maximum output
power of transmitter
Watts (W)
0�01
0�1
1
10
100
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be
estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer�
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies�
NOTE 2: These guidelines may not apply in all situations� Electromagnetic propagation is affected by absorption and reflection from
structures, objects and people�
HOW SUPPLIED
Device Details
The Visual-ICE Cryoablation System is supplied non-sterile and is intended for multiple use� Boston Scientific accessory
products required to perform the cryoablation procedure are supplied separately�
Do not use if package is damaged or unintentionally opened before use�
Do not use if labeling is incomplete or illegible�
Handling and Storage
Operating Conditions
• Temperature: 10 °C to 40 °C
• Relative Humidity: 30 % to 75 %
Storage Conditions
• Temperature: -15 °C to 50 °C
• Relative Humidity: 10 % to 90 %
Transportation Conditions
When shipping the Visual-ICE Cryoablation System, use the original shipping container to prevent damage from
occurring during transport� If the original shipping container is not available, the customer takes responsibility to
ensure proper transport conditions are satisfied or contacts Boston Scientific Technical Assistance Center to obtain the
appropriate shipping container�
CAUTION: Do not set food, drinks, or other objects on top of the System� Doing so may damage the system�
Black (K) ∆E ≤5.0
Separation distance according to frequency of transmitter Meters (m)
150 kHz to 80 MHz
0�117
0�369
1�167
3�689
11�667
22
80 MHz to 800 MHz
0�117
0�369
1�167
3�689
11�667
800 MHz to 2.5 GHz
0�233
0�738
2�333
7�379
23�333
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