Horizon Imager User’s Manual B-3
Specifications
Environment: Operating:
Altitude: 700 to 1060 hPa (0.7 to 1.05 atm)
Temperature: 15 to 30°C (59 to 86°F)
Ambient temperature
for maximum print
speed: 22.2°C (72°F)
Humidity: 10% to 80% noncondensing
Shipping and Storage:
Altitude: 500 to 1060 hPa (0.5 to 1.05 atm)
Temperature: -22.2 to 50.6°C (-8 to 123°F)
Humidity: 5% to 85% noncondensing
Intentional Horizon transmits radio frequency energy at 13.56 MHz using
Transmitters: ASK modulation. Maximum Effective Radiated Power: 200mW
Medical Compliance FDA cleared to market per 510(k) K021054 and K060440,
and Regulatory: Class II MDD CE, GMP/QSR, and Regulatory: ISO13485:
2003, Safety IEC/EN 60601-1 and EMC/EMI EN 55011(B) &
IEC 60601-1-2 Class B for Healthcare facilities
Laser Classification: Class I laser product according to IEC 60825-1 and
21 CFR 1040.10 and 1040.11.
FDA Classification: Class 2 equipment, Product Code LMC, Medical image
hardcopy device
IEC 60601-1 Class I equipment, type ordinary IXPO continuous with
Classification intermittent loading
CAUTION
Federal law restricts this device to be sold for use by or on the order of a
physician.
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