Computer Requirements; Electrical Requirements; Compliance To Standards - GENDEX DenOptix QST Manual Del Usuario Y De Servicio

4.4

Computer requirements

CPU Speed
Operating system
RAM
Hard Drive
USB port
Monitor
Video Display Adapter 4 MB RAM, 800 x 600 display,
Keyboard, Mouse
Backup Device
Printer
1 To be evaluated based on the number of images taken, and the image file size used by the imaging software.
4.5

Electrical requirements

Voltage
Power
Power Cord
4.6

Compliance to standards

The DenOptix QST System conforms to the following standards:
Standard
UL 60601-1
21 CFR Chapter I
Subchapter J
MDD 93/42/ECC
CAN/CSA-C22.2
No. 601.1
IEC 60601-1
IEC 60601-1-2
IEC 60825-1
ISO 13485
ISO 14971
User and Service Manual
Minimum Computer Requirements
800 MHz
Microsoft® Windows® 2000 /XP Pro
SP2
128 MB
6 GB
USB 2.0
S-VGA with 0.25mm/0.26mm
dot pitch
true color
Standard
Highly recommended
Recommended (see appendix C)
100-240 V AC 50/60 Hz power supply auto-senses the input voltage.
110 watts maximum
Standard line cord provided (Medical Grade for 115V)
Title
Medical Electrical Equipment, Part 1: General requirements for safety
Performance Standard for Light-Emitting Products
European Medical Device Directive (CE Mark)
Medical Electrical Equipment, Part 1: General requirements for safety
Medical Electrical Equipment, Part 1: General requirements for safety
Medical Electrical Equipment, Part 1: General requirements for
safety- Collateral standard; Electromagnetic Compatibility
Safety of Laser Products
Medical devices- Quality management systems
Risk Analysis
21
Gendex DenOptix® QST
Recommended
Pentium 4 2.4 GHz
Microsoft® Windows® XP Pro
SP2
256+ MB
40+ GB 1
USB 2.0
S-VGA with 0.25mm/0.26mm
dot pitch
8+ MB RAM, 1024x768
true color
Standard
Doc # M010-004WWE July 2005