English
Intended use (Continued)
EN
•
For use in all clinical settings including coronary care units, operating, recovery and emergency departments, burn
units, and medical/surgical units
•
Adult and pediatric patients
•
Monitoring and controlling patient temperature
•
Temperature reduction in patients where clinically indicated, e.g. in hyperthermic patients
•
Mild therapeutic hypothermia for post cardiac arrest
•
Mild therapeutic hypothermia Neonatal hypoxic ischemic encephalopathy (HIE)
•
Mild therapeutic hypothermia post traumatic brain injury (TBI)
Intended users
•
Physicians
•
Advanced Practice Registered Nurses
•
Nurses
Expected service life
The Altrix controller has a five year expected service life under normal use, conditions, and with appropriate periodic
maintenance. See the maintenance manual for preventive maintenance and service information.
Contraindications
For core body temperature regulation:
•
Raynaud's Phenomenon (primary or secondary)
•
Application to lower extremities distal to aortic cross-clamping
For inducing mild hypothermia
Absolute
•
Hemorrhagic stroke
•
Cardiac arrest due to trauma
•
Glasgow Coma Scale (GCS) >=eight
•
Cardiac arrest due to drug overdose
•
Pre-existing hypothermia (<34.0° C; 93.2° F)
•
Uncontrolled active bleeding
•
Uncontrolled hemodynamically unstable arrhythmias
Relative
•
Thrombocytopenia (platelet count <50x109/L) or baseline coagulopathy
•
Severe refractory hypotension (mean arterial pressure <60mmHg) not corrected by fluid infusion, vasopressors or
invasive hemodynamic support
•
Prolonged cardiac arrest (>60 minutes)
•
Pregnancy
•
Terminal condition
•
Valid Do Not Resuscitate (DNR) directives
•
ROSC greater than six hours
1-8
Introduction
8001-109-005 REV B
www.stryker.com