Ziehm Imaging, Inc. QUANTUM, User Manual, Page: 15 / 220

Section 1.0
MAN 06–0017H
ZIEHM QUANTUM
User’s Manual Page 15 of 220
country;
•
The system is used in accordance with the User Manual.
The warranty becomes invalid when any repair, modification, or installation work is carried out
by unauthorized personnel. No consequential damages will be accepted either. The equipment
conforms to Class IIb according to the Council Directive 93/42/EEC. This User Manual has been
written and reviewed originally in German and translated.
1.8 USA REGULATORY RESPONSIBILITIES
1.8.1 SERVICE ENGINEERS/TECHNICIAN
Service Engineers/Technicians are responsible for installing, calibrating, and maintaining the C-
Arm system. In order to be qualified to perform the procedures described in the Service Manual,
Service Engineers must attend formal training provided by
Ziehm Imaging, Inc. (hereafter
referred to as the manufacturer).
1.8.2 SYSTEM USERS
System Users are responsible for reading and following each section of this manual that applies to
them. The user should not attempt any procedures in this manual that are described as a service
task. USERS shall contact manufacturer to perform service related tasks described in this manual.
1.9 CDRH REPORT
The CDRH Maintenance Manual contains or may refer to test procedures that the Center of
Disease and Radiological Health (CDRH) requires to be performed as the system is installed and
prior to customer acceptance. A list of the equipment required to conduct these tests is included.
Use only this equipment, or approved substitutes. This manual includes reference to forms for
recording required tests. Make copies of these forms and safeguard the original. As tests are
conducted, record the results onto a blank copy of the form. Keep the original, and send a copy to
the manufacturer at the following address:
Ziehm Imaging, Inc. ; 4181 Latham Street; Riverside,
CA 92501. If you have any questions concerning testing, call the manufacturer at: 951-781-2020,
and ask for the Service department.
Maintain original copies of completed forms for future
reference.
1.10 PROBLEMS
If System Users have an equipment-related problem, they must immediately stop using the
system and notify a Service Engineer. The system must not be operated until repairs have been
made and the proper functioning of the system is verified.
1.11 REGULATORY /NOTIFIED BODY
Ziehm Imaging, Inc. USA
1. The Food and Drug Administration (FDA) is our Regulatory Body.
1.12 RECORD KEEPING USA
Service Engineers are responsible for: