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Section 12.0
MAN 06–0017H
ZIEHM QUANTUM
User’s Manual Page 181 of 220
12.0 TECHNICAL DATA
This chapter presents technical information for the ZIEHM QUANTUM C-Arm, and includes
heating and cooling charts and dose display.
Ziehm Imaging, Inc. reserves the right to make changes in specifications at anytime without
prior notification.
Technical data Ziehm Vision (U.S.A.)
12.1 SAFETY CLASSIFICATION
12.1.1 STATEMENT OF COMPLIANCE IEC STANDARDS:
•
IEC 601-1:
•
IEC 601-2-7:
•
IEC601-2-8:
•
IEC 601-2-32:
The ZIEHM QUANTUM is classified as Class I, continuous-use, type B equipment.
12.1.2 FDA PRODUCT CLASSIFICATION NAME / CODE:
•
Complies with FDA/CDRH radiation performance standards, 21 CFR Subchapter J, as of
the date of manufacture.
•
System, X-Ray, Fluoroscopic, Image Intensifier,
•
Product Code: JAA
•
Regulation number: 892.1650
WARNING:
The ZIEHM QUANTUM is not suitable for use in a flammable atmosphere .
WARNING:
Rapid changes to temperature can damage system components. DO NOT operate system
until equipment has reached a safe operating room temperature. Severe damage may
occur! Failure to observe this warning will result in loss of warranty and sever damage
to the device. Several hours may be required for system to reach safe temperatures.
NOTE:
Environmental limits for system.
Transport: -10
0
–60
0
C, Humidity 10% - 95% non condensing, Pressure: 500 – 1060mbar
Operational: +10 – 35
0
C Humidity 35% - 75% non condensing
12.2 TECHNICAL SPECIFICATION
Table -Technical data of the ZIEHM QUANTUM U.S.A.)