DOCUMENT NO. 920012 REV 2 EFFECTIVE 03-14-18 INFRASCAN CONFIDENTIAL PAGE 7 OF 35
including intraventricular hemorrhage. The performance of the Infrascanner has not
been established for the detection of posterior fossa hemorrhage.
•
The performance of the Infrascanner in detecting subarachnoid hemorrhage alone or
with other types of hemorrhage has not been established.
•
Because Infrascanner result is based on the difference in infrared light absorption on
homologous left and right regions of the skull:
o
The Infrascanner result may be negative in the presence of bilateral hematomas of
similar size and location.
o
The Infrascanner may only detect the larger of bilateral hematomas in a similar
location.
o
The performance of Infrascanner may be affected by the presence of blood within or
under the scalp and by the presence of scalp edema.
o
The performance of Infrascanner may be affected by increased skull thickness.
o
The Infrascanner cannot detect chronic (non-acute) hematomas.
•
Do not re-use the Disposable Fiber Optic Shield on another patient. The Disposable
Shield is for single patient use only. When the Disposable Shield contacts the patient, it
is capable of transferring infectious agents.
•
The Infrascanner should not be used on patients for whom the use of an unsterilized
device might pose a risk of infection.
INTENDED USE/INDICATIONS
The Infrascanner is indicated for the detection of traumatic supratentorial hematomas of
greater than 3.5 mL in volume that are less than 2.5 cm from the brain surface, as an
adjunctive device to the clinical evaluation in the acute hospital setting of adult and
pediatric patients with suspected traumatic supratentorial intracranial hematoma. The
device is indicated to assess patients for CT scans but should not serve as a substitute for
these scans. The Infrascanner is indicated for use by Physicians, or under the direction of
a physician, who has been trained in the use of the device.
