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).

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MediSense PCx manual Environmental Specifications, Symbols