I
NFRA
S
CAN Infrascanner Model 2000 Operator Manual
INFRASCAN, INC. VERSION 1 Page 8 of 41
1.0 System Information
1.1 Classification.
1.2 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 patients 18 years
old or greater with suspected traumatic supratentorial intracranial hematoma. The device is
indicated to assess patients for Computed Tomography (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.
1.3 Specifications.
1.3.1 Physical Specifications:
a. Dimensions with Disposable: 9.0H x 3.4W x 2.4D inch (23H x 8.5W x 6.1D cm).
b. Dimensions without the Disposable Fiber Optic Shield: 9.0H x 3.4W x 1.8D inch
(23H x 8.5W x 4.6D cm).
c. Weight of Infrascanner: 14oz (400g).
d. Number of detectors: 1.
e. Number of light sources: 1.
f. Light Source - Detector Separation: 4 cm.
1.3.2 Functional Specifications:
a. Power 4.8V, Rechargeable NiMH Battery pack (1AH) or 4 AA disposable
batteries.
b. Standby time 2 weeks.
c. Operating time on new fully charged batteries: >60 minutes.
1.3.3 Laser Diode Specifications:
a. Wavelength: 808nm (±3nm).
b. Maximum peak pulsed power: 100 milliwatt.
c. Safety: Class 1 Laser Product.
•
Equipment Function:
Detection of superficial supratentorial traumatic
intracranial hematomas
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Degree of protect against elec.
Shock:
Type BF applied part.
•
Supply connection:
Internal rechargeable or disposable battery
•
Cradle Power Adapter:
Medical Grade 5 VDC at >1 Amp
•
Mode of Operation:
Continuous with intermittent loading
•
Degree of mobility:
Handheld
•
Laser Classification:
Class 1 Laser Product
Summary of Contents for 2000
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