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The Precision PCx Point-of-Care System's performance has been
evaluated in clinical studies at seven independent sites. In all the
studies, the Precision PCx Monitor was calibrated and used according
to the labeling.
Environmental Specifications
Product is intended for indoor use
Monitor Operating Temperature: 32°F to 115°F (0°C to 46°C)
Monitor Storage Temperature: -11°F to 115°F (-24°C to
46°C)
Altitude: Up to 2,195 meters
Monitor Humidity: From 10% to 90% within the
range of 32°F (0°C) to 115°F
(46°C)
Mains Supply Voltage Fluctuations: ±10%
Transient Over-Voltages: ±1.5V
Rated Pollution Degree: 2
Other Information
There are special symbols that appear on the Precision PCx Monitor,
Precision PCx and Precision PCx Plus Test Strips, and Docking Station.
The complete list of symbols and an explanation are listed below.
Please note: Some of the symbols listed below will not appear on your
Precision PCx Monitor and Docking Station due to differences in local
regulatory requirements.
Symbols:
Refers to Type B Equipment, Per EN60601-1.
The double arrow symbol indicates the connector to be used
for data transfer. The double arrow symbol also appears on
the front panel of the docking station, beneath the LED
display. If the LED is steady, this indicates that the monitor is
properly placed in the docking station. If the LED is flashing
this indicates that data transfer is in process (refer to Data
Upload, Section 9).
The CSA mark means that an evaluation of samples of
Equipment has been performed by CSA to determine
compliance with specific requirements (CSA, CS22.2
No. 601.1).