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Introduction and Safety
1.3. Manufacturer's Responsibilities
GE HUALUN Medical Systems, Co. Ltd. certifies each system and X-Ray source assembly. After-sale
operating practices and safety are the responsibility of the owner/operator.
1.3.1. X-Ray Equipment Certification
GE HUALUN Medical Systems, Co. Ltd. certifies that when assembled according to manufacturer's
instructions, the X-Ray equipment complies with applicable international standards.
1.3.2. After-sale Operating and Safety Practices
GE HUALUN Medical Systems, Co. Ltd. assumes no responsibility or liability for personal injury or damage
resulting from misuse of its systems.
1.3.3. Essential Performance
In order to meet its intended use and comply with regulatory standards, the system provides the following
essential performances:
1.
Patient/Image database integrity;
2.
Acceptable fluoroscopic image quality;
3.
Display & Indication of Last Image Hold (LIH) following termination of X-ray exposure;
4.
Maintain X-ray tube voltage accuracy within 10%;
5.
Ensure increment/decrement between two settings is within 50% to 150% of indicated change;
6.
Maintain X-ray tube current accuracy within 20%;
7.
Maintain current time product at +/- (10% + 0.2mAs);
8.
The coefficient of variation of MEASURED VALUES of AIR KERMA is not greater than 0.05 for any
combination of LOADING FACTORS;
9.
Linearity of AIR KERMA in RADIOGRAPHY is not greater than 0.2;
10. Automatic Brightness Stabilization (ABS) function implementing the Automatic Exposure Rate Control
feature;
11. Provide radiation dose structured report (RDSR) as per IEC/PAS 61910-1:2007.
1.4. Communication Center Telephone
Numbers
If the system does not operate properly or fails to respond to the controls as described in your operator's
manual, call GE HUALUN Medical Systems, Co. Ltd. to request service. The communication center's
telephone and Fax numbers are listed below:
GE HUALUN MEDICAL SYSTEMS CO. Ltd.
No 1 Yong Chang North Road
Beijing Economic-Technological Development Zone
Beijing CHINA.
P.O.: 100176
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