The Precision Xceed Pro Point of Care System’s performance has been evaluated in clinical studies at three independent
sites. In all the studies, the Precision Xceed Pro Monitor was calibrated and used according to the labeling.
Precision PCx Plus Test Strips
The following information regarding Precision PCx Plus Blood Glucose Test Strips can be found in the test strip
instructions for use:
Strip Temperature Ranges for Testing •
Storage and Handling •
Quality Control•
Limitations of the Procedure•
Performance Characteristics•
Precision Xceed Pro Monitor
Dimensions:
Length: 19.7 cm (7.7 in)
Width: 7.5 cm (2.96 in)
Thickness: 5.33 cm (2.1 in)
Weight: 256 grams (9 ounces)
Power Source:
Two standard alkaline AA batteries or nickel-metal hydride (NiMH) rechargeable batteries (not supplied by Abbott
Diabetes Care). Battery performance is a function of how often the monitor is used and the duration time that testing
is conducted.
Alkaline Battery: (2) cells 1.5 Volts, 2.8 Amp Hours typical capacity
Rechargeable NiMH batteries (2) cells 1.2 Volts, 1.1 Amp Hours minimum capacity
(not supplied by Abbott Diabetes Care.)
Memory:
Patient Test Results: 2,500
Control Test Results: 1,000
Operator IDs: 6,000
Test Strip Lots: 18 Glucose
Proficiency Test Results: 20
Glucose Linearity Test Results: 20 Results (1 panel, 5 levels, 4 replicates per level)
Patient IDs: 6,000 patient records (name, gender, date of birth)
Environmental Specifications:
Product is intended for indoor use only.
Monitor Operating Temperature: 59 °F to 104 °F (15 °C to 40 °C)
Monitor Storage Temperature: -4 °F to 122 °F (-20 °C to 50 °C)
Altitude: Up to 7,200 feet (2,195 meters)
Humidity:
From 10% to 90% noncondensing
Mains Supply Voltage
Fluctuations: ±10%
Transient Over-Voltages: ±1.5KV Rated
Rated Pollution Degree: 2
Specifications
12-1
Chapter 12: Specifications/LimitationsQuestions? Refer to Page 10-9 For Technical Support Instructions.
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