IfU TECOTHERM NEO TN300 EN - 01.doc
Page 17 of 76
Ref No. TN300 EN-01
Treatment and operation modes of TECOTHERM NEO
TECOTHERM NEO is designed as a physiological closed- loop control system PCLCS ,
see this section
.
Three treatment and operation modes of TECOTHERM NEO
1 Programmable Complete Treatment Mode (Servo controlled mode)
2 Servo Control Mode (constant rectal temperature)
3 Constant Mattress Temperature Mode
Note: The operator can permanently follow the Rectal Temperature on the display
screen, see section 7.3.
Treatment Mode 1
Programmable Complete Treatment Mode (Servo controlled mode)
(automatic mode, treatment protocol)
System is designed for inducing hypothermia in a patient by total body cooling. Details
for inititial operation see section 8.
Note
This mode is limited to temperatures and
profiles stated in the TOBY Study protocol
(see reference) for inducing hypothermia in neonate
suffering from Hypoxic Ischemic Encephalopathy
Rectal temperatures can be selected and set within a range
32°C to 38°C
.
Temperature is accurately adjusted and finely tuned.
Necessary TECOTHERM NEO system equipment to run treatment is
TECOTHERM NEO device
Mattress for total body cooling, filled, protecting foil interlayer
Rectal Temperature Probe, Skin temperature probe
Themally shielded hoses to connect mattress to the device.
All equipment parts should be checked and prepared to start treatment, see section 8
of this IfU. Patient – neonate – should be placed onto the mattress/ cool wrap.
Rectal probe should be inserted and secured.
To start treatment you have to follow and observe the instructions of the MENU.
Operation Mode 1 has five (5) treatment sections/ phases.
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