Maquet HCU 40, Instructions For Use Manual

Page: 11 / 148

| HCU 40 | 2 Safety | 11 |
Instructions for Use | 1.0 | EN | 01
Copyright Maquet Cardiopulmonary GmbH
2 Safety
2.1 Intended Use
NOTE
Heat exchanger
Please observe the Instructions for Use for the employed heat exchangers with
regard to the indications, intended use, intended user, intended patient, intended
environment, and contraindications.
2.1.1 Indications
The intended purpose of the heater-cooler unit HCU 40 is cooling and warming a
patient and maintaining the patient temperature at the required level during
cardiovascular interventions. Temperature changes are effected by means of a
combined oxygenator with heat exchanger in the extracorporeal perfusion circuit.
The system comprises two separate water circuits with temperature regulation.
The first circuit is for connecting the oxygenator heat exchanger and/or the
warming/cooling blanket; the second circuit is intended for connecting the
cardioplegia heat exchanger. Heat exchange between the patient and the
cardioplegic fluid occurs by the temperature-regulated water flowing through the
heat exchanger and/or the warming/cooling blanket. The water temperature of the
patient water circuit and the cardioplegia water circuit can be regulated
independently of each other. The water temperature can be set between 1°C and
40.5°C.
External temperature sensors can be optionally combined with the HCU 40, and
can be used to operate the HCU 40 in gradient mode. The purpose of this mode
is to provide physiologically optimized warming and cooling of the patient.
2.1.2 Intended Use
The heater-cooler unit HCU 40 is intended for cooling or warming a patient
connected to the extracorporeal perfusion circuit and keeping the required patient
temperature constant. The temperature transfer occurs via a heat exchanger in
the patient perfusion circuit and/or cardioplegia water circuit and/or via a warming/
cooling blanket.
2.1.3 Intended User
The HCU 40 may only be operated by trained specialist medical staff.