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Specific performance characteristics
Table 1. Glucose 201 RT System ranges.
Measuring range
Displayed range
Whole
0.55–27.8 mmol/L
0–27.8 mmol/L
blood
(10–500 mg/dL)
(0–500 mg/dL)
system
Plasma
0.61–30.8 mmol/L
0–30.8 mmol/L
equvalent
(11–555 mg/dL)
(0–555 mg/dL)
system
If the results exceed the measuring range of the system "HHH" will be displayed.
If the patient assessment does not align with results from the HemoCue Glucose
201 RT System the test results should be verified against a reference method.
Table 2. Glucose 201 RT accuracy and bias, capillary and venous blood samples (results in whole
blood).
Sample
N
Min–Max
Regression
type
mg/dL
line
Venous
104
32.6–460.5
Y =
(vs. ID
1.06X – 3.55
GC-MS)
Capillary
102
13.1–476.0
Y =
(vs. YSI
1.00X + 2.15
2300
STAT
Plus)
Note: To convert values in mg/dL to mmol/L divide by 18.016
Table 3. Glucose 201 RT repeatability and within-laboratory precision (results for liquid control
material).
Limit of
Linear range
Detection (LoD)
Control
0.55 mmol/L
0–27.8 mmol/L
(10 mg/dL)
(0–500 mg/dL)
0.61 mmol/L
0–30.8 mmol/L
(11 mg/dL)
(0–555 mg/dL)
Note: To convert values in mg/dL to mmol/L divide by 18.01
Technical Specifications
Dimensions: 85 × 160 × 43 mm (3.35 × 6.3 × 1.69 inches)
Weight: 350 g (0.77 lbs) with batteries installed
Battery: 4 batteries type AA, 1.5 V Alkaline
Correlation
Glucose
Bias
Power adapter: CE marked. Type FW7333SM/12, FW7660M/12, FW8002.1/12
coefficient r
level
Only use power adapters recommended by HemoCue.
mg/dL
Analyzer electrical rating: 12 V
0.998
0–50
-4.5 mg/dL
Pollution degree: 2
51–120
2.2 mg/dL
121–200
2.9%
Overvoltage category: II
201–300
4.6%
Altitude: up to 2000 m above sea level
301–400
4.4%
The instrument is made for continuous mode
401–500
4.3%
0.997
0–120
1.3 mg/dL
Warranty
121–400
1.3%
The analyzer carries a 24-month warranty from the day of receipt. After the expi-
401–500
0.7%
ration date of the warranty, maintenance and repairs are offered at a fixed price.
For technical difficulties or repair contact your local distributor or HemoCue AB.
Any other use of the system than recommended by the manufacturer will void the
warranty.
50
Repeatability
N
Mean
SD
pooled
level
mg/dL
mg/dL
(mmol/L)
(mmol/L)
1
800
45.9 (2.5)
1.15 (0.064)
2
800
101.8 (5.7)
1.36 (0.075)
4
800
305.7 (17.0)
3.26 (0.180)
, 1 W
Within-laboratory precision
CV
SD
CV
pooled
%
mg/dL
%
(mmol/L)
2.5
1.28 (0.071)
2.8
1.3
1.62 (0.090)
1.6
1.1
3.72 (0.210)
1.2
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