IfU TECOTHERM NEO TN300 EN - 01.doc
Page 7 of 76
Ref No. TN300 EN-01
4.
Short Description of the Equipment
The Hypothermia System TECOTHERM NEO is designed for controlled cold & heat
treatment procedures and application of specific cold and heat doses to neonate and
babies. The system applies cold and heat to total body, body parts and areas
depending on therapy target by means of mattresses and / or cool wraps NEO PAD.
One main application is hypothermia treatment of neonate affected with Hypoxic
Ischemic Encephalopathy.
Another application designed for controlled hypothermia treatment is Total Body
Treatment of Children up to body mass of 50 kg.
TECOTHERM NEO consists of a unique cold & heat generating device, applied parts
like mattresses and wrap, interconnecting hoses (tubing set), accessories. Applied
parts are connected to the device via hoses by self- sealing quick- disconnect
couplings.
The patient is provided with cold and heat according therapy target in a fully controlled
way by a circulating fluid. This physiologically safe water- based fluid is cooled or
warmed in the device and flows through the mattress or wrap continuously supplying
the patient with therapeutically prescribed doses.
Patient temperatures are measured with approved calibrated probes connected to the
TECOTHERM NEO device. Temperature data is permanently communicated to the
device Operational System.
Circulation of thermalizing fluid to provide cold and heat, accurately reaching set points
and operating at set point temperatures accurately with max. deviation of +/-0,3°C,
monitoring the treatment, and alarming when when exceeding or falling below
temperature limits are Essential Performances of TECOTHERM NEO.
TECOTHERM NEO is electronically divided into a
Operational System
and a
Controlling System.
Both sub systems are micro computer (µC) based. Both µC
communicate permanently to ensure safe and proper operation according to therapy
needs.
A comfortable user MENU will guide the operator to the treatment modes, advise how
to proceed the treatment and how to manage treatment details.
Menu language may be preselected using Main Menu: English, Deutsch, Espanol …. .