Siemens Drager medical Carina, Instructions For Use Manual, Page: 14 / 144

Intended Use
14
Instructions for Use Carina SW 3.n
Intended Use
Carina – long-term ventilator for ventilator-depend-
ent patients or ventilator-assisted patients.
– For treatment of sub-acute care patients in hos-
pital or medical rooms.
– For invasive ventilation or non-invasive ventila-
tion.
– For patients with a tidal volume of at least
100 mL.
– For use by qualified medical personnel.
Sub-acute care definition*
Sub-acute care is comprehensive, inpatient care
for patients who:
– Have had an acute event resulting from injury,
illness or exacerbation of a desease process;
– Have a determined course of treatment;
– Though stable, require diagnostics or invasive
procedures, but not intensive procedures
requiring an acute level of care.
The severity of the patient’s condition requires:
– Active physician direction with frequent on-site
visits;
– Professional nurse care;
– Complex medical and/or rehabilitative care.
Typically sub-acute care is designed to return
patients to the community or transition them to a
lower level of care.
WARNING
Not intended for acute inpatient care of non-
stabilized patients who require ventilation
with comprehensive continuous monitoring
according to IEC 60601-2-12 or EN 794-1.
* References:
National Association of Subacute and Post Acute Care
(NASPAC)
The American Health Care Association (AHCA)
The Joint Commission on Accreditation of Healthcare
Organizations (JCAHO)
FDA Consumer magazine September-October 1999