Chapter 3 Safety
1 General Safety Guidelines
This chapter provides information about safety precautions and procedures. It is important for
you to read and understand the contents of this chapter so the correct precautions and
procedures are followed. This manual should be kept near the scanner desktop for easy access.
United States Federal Regulation 21CFR 801.109
CAUTION
Federal law restricts this device to sale by or on the order of a physician.
•
This product was designed and manufactured to ensure maximum safety of operation. It
should be operated and maintained in strict compliance with the safety precautions,
warnings and operating instructions contained herein, and in any other documentation
specific to the product.
•
The system has been designed to meet all the safety requirements applicable to medical
equipment. However, anyone attempting to operate the system must be fully aware of
potential safety hazards.
•
The manufacturer or vendor of the equipment makes no representation, however, that the
act of reading this manual renders the reader qualified to operate, test or calibrate the
system.
•
The owner should make certain that only properly trained, fully qualified personnel are
authorized to operate the equipment. A list of authorized operators should be maintained.
•
This manual should be kept at hand, studied carefully and reviewed periodically by the
authorized operators.
•
Unauthorized personnel should not be allowed access to the system.
•
Do not leave the patient unobserved at any time.
•
Become familiar with the functional hardware so that you can recognize serious problems.
Do not use the system if it appears damaged or fails. Wait for qualified personnel to correct
the problem.
•
Abbreviations used in the operator manuals can be found in this manual.
•
If the product does not operate properly or if it fails to respond to the controls as described in
this manual, the operator should:
○
First ensure the safety of the patient.
○
Next ensure the protection of the equipment.
○
Evacuate the area as quickly as possible in any potentially unsafe situation.
○
Follow the safety precautions and procedures as specified in this manual.
Revolution CT User Manual
Direction 5480385-1EN, Revision 1
Chapter 3 Safety 45
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