Fluke Biomedical INCU Incubator Analyzer - Manual (Page 18)

INCU
Operators Manual
1-6
AAMI/IEC Standards
The AAMI and IEC standards specify sound levels, CO
2
concentration, and
thermal characteristics for incubators. The standards are used by
manufacturers when designing and manufacturing incubators. INCU was
designed with consideration of the standards, and can perform testing to
satisfy many testing requirements.
Incubator Standards
Standard# Description
IEC 601-2-19 Infant Incubator Tester Safety Requirements
IEC 601-2-20 Safety Requirements for Transport Incubators
IEC 601-2-21 Infant Radiant Warmer Standard
ANSI/AAMI 1136-1997 Infant Incubators
INCU Applications
The following section provides information describing how INCU can be
used to perform testing in consideration of the standards.
1.
Temperature – Standard: During steady state condition, the
INCUBATOR TEMPERATURE shall not differ from the AVERAGE
INCUBATOR TEMPERATURE by more than 0.5
°C (1°C transportable)
during at least 1 hour at the control temperatures of 32°C and 36°C.
INCU: The user shall check the oscillation from min to max in steady
state.
2. Temperature - Standard: The AVERAGE TEMPERATURE in each
point A,B,C,D,E, shall not differ from the AVERAGE INCUBATOR
TEMPERATURE (test at a set T of 32
°C - 36°C) by more than ±0.8°C
( ±1.5°C transportable).
INCU: In any position of the tilted mattress, it shall not differ by more
than
± 1.0 ° C ( ± 2.0 ° C transportable). Calculate manually the difference
between the mean value at the center and the other sensors readings.
3. Temperature - Standard: The TEMPERATURE as measured by the
skin temperature sensor shall not differ from a reference sensor
temperature by more than 0.3
°C in steady temperature condition.
INCU: Check the difference between the value given by the T2 sensor
and the value displayed by the skin sensor when placed in close
proximity to the T2 sensor.
Note: For up-to-date standards, please visit AAMI.org or IEC.org .
Note: The following are examples of standards for description
proposed. Please reference the current application to determine
your testing protocol.