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System—Environmental
U.S. Gov't. Classification—
Ingress Protection
U.S. Gov't. Classification—
Console and Power Supply
Classification—
Handpiece
Environmental conditions
for transportation
and storage
Relative humidity range
Atmospheric pressure range
Environmental conditions
for operation
Caution: System installation shall be in accordance with the requirements of IEC 60601-1-1, The
Standard for Safety Requirements of Medical Electrical Systems.
Patients should only be connected to applied parts of equipment complying with IEC 60601-1. Other
equipment used in the system should comply with relevant IEC or ISO Standards.
Computer Requirements
Minimum System Requirements (*)
Operating
Microsoft® Windows®
2000-PRO or XP-PRO
System
800 MHz (*)
Processor
1.3 GHz if a laptop computer is used (*)
128 MB
Memory
10 GB
Hard Disk
1024x768 at 32 bit true color
Display Setting
Video memory
8 MB
SVGA with 0.25mm/0.26mm dot pitch
Monitor
FireWire or i.LINK
Ports
(IEEE-1394a standard)
Microsoft DirectX 9.0b or higher required
Drivers
(*) Note: "Minimum Requirements" are necessary to obtain a good live video stream in a window a
quarter-of -screen big, while the "Recommended Requirements" are necessary to obtain a fluent
live video stream without any "jittering" effect in full-screen mode.
Note: Processor Speed Requirements are higher if a laptop PC is being used. For the best
performance with laptops, please make sure that the PC power supply is connected when the
FWT
Concept IV
is streaming video.
FWT
AcuCam Concept IV
IPXO
Medical Grade
Cabled camera head,
Medical Grade Type
BF
-25˚C — 70˚C
10% — 100%
500 hPa — 1060 hPa
+10˚C — 40˚C
13
System—Conformance
Evaluated to meet the Requirements of the
Medical Device Directive (MDD)
as a Class 1 Device, UL-C 2601-1 and IEC60601-1.
Immunity testing was performed according to
IEC 60601-1-2, Electromagnetic Compatibility
Suitable for
Yes
continuous operation
FDA/21 CFR 820
Class 1
Recommended System Requirements
Microsoft® Windows®
XP-PRO
1.3 GHz or higher
1.8+ GHz if a laptop computer is used
256 MB
20+ GB
1024x768+ at 32 bit true color
32+ MB
SVGA with 0.25mm/0.26mm dot pitch
FireWire or i.LINK
(IEEE-1394a standard)
Microsoft DirectX 9.0b or higher required
Operation Manual and Installation Guide
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