Ziehm Imaging, Inc. QUANTUM, Руководство пользователя, Страница: 188 / 220

Section 12.0
MAN 06–0017H
ZIEHM QUANTUM
User’s Manual Page 188 of 220
12.7 LASER ALIGNMENT
Laser Class 11 < 1mW Standards:
IEC 60825-1:2001
FDA 21CFR1040
Max. power output
of continuous laser radiation, measured at the laser
beam apertures <1 mW
Wavelength of the radiation 635 nm
12.8 DOSE AKR AND CUMULATIVE AIR KERMA MEASUREMENT
Technical data of Dose measurement
Accuracy The displayed AKR and cumulative air Kerma shall
not deviate from the actual values by more than ±35
percent
Compliance Compliance shall be determined with an irradiation time
greater than 3 seconds.
Measuring range AKR 6mGy/min to max
Measuring range Cumulative 100mGy to max
12.8.1. Calibration of calculated dose measurement 21CFR 1020.33 (k) (4) (ii)
The Equipment Owner is responsible for ensuring that only persons who are trained and qualified
are allowed to service and make adjustments.
The Equipment Owner is responsible for ensuring that the x-ray system complies with the
applicable sections of CFR 21 1020.30 (h) (6) (i), Compliance must be periodically verified by
subjecting the system to various test procedures defined by the Center for Disease and
Radiological Health (CDRH) including the calculated dose measurement system
If the system fails to operate correctly, or fails to respond to system controls as outlined in this
manual, notify the local, authorized
Ziehm Imaging, Inc. dealer representative.
Only authorized personnel are allowed to assemble and/or repair the medical equipment described
in this manual. Authorized personnel are persons who have attended an appropriate training
course provided by the manufacturer.
Calibration of the generator or the dose measurement system shall only be performed by trained
and authorized personnel. Calibration procedures are part of the technical documentation and are
not outlined in this manual.
12.8.2. AKR / CUMULATIVE DOSE DISPLAY CALCULATION
The ZIEHM QUANTUM calculates the dose values based on the kV, mA as well as time of the
radiation exposure. The display automatically changes between live display of Air Kerma
(AKR) or the Cumulated Air Kerma values ( AKR x Fluoroscopy Time ) automatically sets the