Andesfit Health ADF-B27A Kullanıcı Kılavuzu - Sayfa 18
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Performance Characteristics
Measurement Precision
Repeatability
Mean (mg/dL)
40.3
SD (mg/dL)
2.6
CV (%)
-
Intermediate precision
Mean (mg/dL)
SD (mg/dL)
CV (%)
System Accuracy
For glucose concentration < 100 mg/dL
Within±5 mg/dL
101/180(56.1%)
For glucose concentration ≥ 100 mg/dL
Within±5 mg/dL
195/420(46.4%)
For glucose concentrations between 40.6 mg/dL and 504 mg/dL
Within±15 mg/dL or ±15%(Within ±0.83mmol/L or ±15%)
Traceability of glucose monitoring system
The results of Blood Glucose Monitoring System were
compared to parallel results obtained on YSI-2300, which is
the manufacturer's standard measurement procedure.
User Performance
A study evaluating glucose values from fingertip, palm and
Forearm capillary blood samples obtained by 100 lay persons
showed the following results:
33
82.0
130
202
3.7
5.1
6.6
4.5
3.9
3.3
44.4
108.1
3.2
3.3
-
3.3
Within±10 mg/dL
Within±15 mg/dL
178/180(98.9%)
164/180(91.1%)
Within±10 mg/dL
Within±15 mg/dL
410/420(97.6%)
349/420(83.1%)
588/600(98.0%)
For glucose concentrations<5.55 mmol/L (<100 mg/dL)
Puncture site
±15mg/dL (±0.83mmol/L)
325
For glucose concentrations≥5.55mmol/L (≥100 mg/dL)
8.4
Puncture site
2.6
Within±15%
ELECTRIICAL AND SAFETY STANDARDS
342
This meter complies with CISPR 11: Class B (Radiated Only).
7.1
Emissions of the energy used are low and not likely to cause
2.0
interference in nearby electronic equipment. The meter has
been tested for immunity to Level 3 electrostatic discharge as
specified in IEC 61326.This meter complies with immunity to
radio frequency interference over the frequency range 80MHz
to 2.5GHz at 3V/m as specified in IEC 61326-1 or 61326-2.
The meter meets the requirements for immunity to electrical
interference at the frequency range and test level specified in
international standard ISO 15197.
CAUTION: Do not use the equipment where aerosol sprays
are being used, or when oxygen is being administered.
Symbol
Fingertip
96.3%
Fingertip
99.3%
SYMBOLS INFORMATION
Referent
Symbol
Use by
Consult instructions
for use
CAUTION
Keep away from
sunlight
Keep dry
Temperature limitation
Palm
Forearm
96.3%
96.3%
Palm
Forearm
98.6%
98.6%
Referent
Date of manufacture
Batch code
In vitro diagnostic
medical device
Catalogue number
Serial number
Control
611.427B0G-001
34