(6) Stability
1) Temperature Stability
Variation of measurement (Activation % for AT III) at 15°C (C
15
) or 35°C (C
35
) from that at 25°C (C
25
) lies
within the following ranges, when this formula is used.
C15 (or C35) - C25
x 100
C25
8
PT, APTT (second) ± 8% or less
Fbg, TTO, HpT (second) ± 10% or less
AT III (%) ± 10% or less
D-Dimmer (µg/L) ± 10% or less
2) Stability within-a-day
Variation of measurement (Activation % for AT III) at the time of 2, 4 and 8 hours from that at 30 minutes
after the power is turned on (initial value) lies within the following ranges. The ambient temperature at the
time of measurement should be within the specified range. Temperature variation must be within 5°C.
( Measurement after 2, 4 or 8 hours ) - ( Measurement at 30 minutes )
x 100
( Measurement at 30 minutes )
PT, APTT (second) ± 8% or less
Fbg, TTO, HpT (second) ± 10% or less
AT III (%) ± 10% or less
D-Dimmer (µg/L) ± 10% or less
3) Long-term Stability (daily variation)
Variations in measurement values (Activation % for AT III) during the continuous 10 days lie within the
following ranges. The ambient temperature at the time of measurement should be within the specified
range. Temperature variation must be within 5°C.
( Measurement after second day ) - ( Mean Measurement )
x 100
( Mean Measurement )
PT, APTT (second) ± 8% or less
Fbg, TTO, HpT (second) ± 10% or less
AT III (%) ± 10% or less
D-Dimmer (µg/L) ± 10% or less
4) Stability against Power Source Variation
Variation of measurement (Activation % for AT III) lies within the following ranges when the rated voltage
changes at ±10%.
( Measurement at +10% or -10% ) - ( Measurement at rated voltage )
x 100
( Measurement at rated voltage )
PT, APTT (second) ± 8% or less
Fbg, TTO, HpT (second) ± 10% or less
AT III (%) ± 10% or less
D-Dimmer (µg/L) ± 10% or less
CA-500 Series S/M 1-6 Revised December 2001
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