Fluke Biomedical INCU Incubator Analyzer User Manual
Page 19
Incubator Analyzer
AAMI/IEC Standards
1-7
4.
Temperature - Standard:
The INCUBATOR shall be provided with an
indicator of the internal temperature. The mean value of the reading of
this device shall not differ from the average incubator temperature
measured by a standard thermometer by more than
±0.8°C (±1°C
transportable), less the standard thermometer
error. The standard
thermometer shall be accurate within
±0.05°C.
INCU: Check the difference between the value of the mean value at the
center and the one displayed by the indicator.
5.
Temperature - Standard:
Working as an air-controlled INCUBATOR,
the average INCUBATOR TEMPERATURE shall not differ from the
control temperature by more than
±1.5°C (±2°C transportable).
INCU: Check the difference between the value of the mean value at the
center and the set value.
6.
Temperature - Standard:
The warm-up time of the equipment shall not
differ by more than 20% from the warm-up time specified in the
instructions for use.
INCU: Check the difference between the time stated by the manufacturer
and the time to raise the temperature by 11 C, starting at the
environmental conditions with a setting temperature 12°C above the
ambient.
7.
Temperature - Standard:
After adjusting the temperature from 30
°C to
34
°C or Transit 32°C to 36°C, the overshoot in the incubator temperature
shall not exceed 2
°C.
INCU: Calculate the overshoot manually.
8.
Standard:
Any indicated value of relative humidity shall have an
accuracy of
±10% (±15% transportable) of the actual measured value.
INCU: Read the value and compare it with the set value.
9.
Sound Pressure - Standard:
In normal use, the sound level within the
baby compartment shall not exceed 60 dB except as specified in 102.2.
INCU: Read the value and compare it with the threshold.
10.
Sound Pressure - Standard:
When any incubator alarm is sounding,
the sound level within the baby compartment shall not exceed 80 dB.
INCU: Activate an alarm, read the value, and compare it with the
threshold.
11.
Sound Pressure - Standard:
Audible alarms shall have a sound level of
at least 80 dB at a distance of 3 m perpendicular to the front of the
control unit.
INCU: Activate an alarm, move the INCU
outside, read the value, and
compare it with the threshold.