IfU TECOTHERM NEO TN300 EN - 01.doc
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Ref No. TN300 EN-01
NOTE
Information and Advice for operators
Users and Operators should intensively read the I f U to become familiar with all
instructions and technical details
To acquaint operators and users with instructions and measures to handle alarms and
situations under single fault conditions is important.
Operator is requested to become mentally familiar with the treatment equipment as a
physiological closed- loop control system PCLCS *) , see section
7.
Note
for operators and users
To be familiar with instructions and measures to
handle alarms and situations under single fault conditions is important.
Note
for operators and users
When placing the TECOTHERM NEO device
positions and motions of patient, operators and other personnel have to be taken into
consideration. Circumstances and situations near TECOTHERM NEO site before,
during and after treatment have to be considered.
Note
for operators Consider possible mechanical means for positioning, supporting or
erecting the patient during treatment. They may block or reduce fluid circulation
We recommend that operator should independently monitor patient temperatures
during treatment.
*)
PCLCS and Mental Model
To develop an imagination on cause and effect in TECOTHERM NEO treatment mode 1,
Section III, a realistic single fault condition scenario is assumed:
Rectal Temperature Sensor
is slipped out the patient’s rectum
.
The probe now detects a much lower temperature measuring ambient air temperature near the
neonate rectum. This temperature shown at the display screen strongly deviates from the BCT
33,5 °C (cause). To reduce the deviation TECOTHERM NEO is increasing the fluid / the
mattress temperature (effect): the Control Board responds with activation of warming to
increase the “ pretended BCT, appearently to low “.
After 5 minute period the device indicates temperature alarm. Display is showing confusing
temperature data: Low rectal temperature, normal skin temperature, high mattress
temperature. But a mentally prepared operator decide to immediately inspect and check the
position of the rectal probe.
