Aspect BIS VISTA, Руководство по эксплуатации

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SECTION 1 SAFETY PRECAUTIONS
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1-1
SECTION 1
1 SAFETY PRECAUTIONS
INTRODUCTION:
Caution:
Carefully read the BIS VISTA Monitoring System Operating Manual
entirely before using the monitor in a clinical setting.
WARNINGS, CAUTIONS, AND NOTES
The terms warning, caution, and note have specific meanings in this manual.
•
A WARNING advises against certain actions or situations that could result in
personal injury or death.
•
A CAUTION advises against actions or situations that could damage equipment,
produce inaccurate data, or invalidate a procedure, although personal injury is
unlikely.
•
A NOTE provides useful information regarding a function or procedure.
KEY TO SYMBOLS
A key to the symbols used on the BIS VISTA Monitoring System appears at the end of this
section.
1.1 Warnings
THE USE OF ACCESSORY EQUIPMENT NOT COMPLYING WITH THE
EQUIVALENT SAFETY REQUIREMENTS OF THIS EQUIPMENT MAY
LEAD TO A REDUCED LEVEL OF SAFETY OF THE RESULTING SYSTEM.
CONSIDERATION RELATING TO THE CHOICE SHALL INCLUDE:
•
USE OF THE ACCESSORY IN THE PATIENT VICINITY
•
EVIDENCE THAT THE SAFETY CERTIFICATION OF THE
ACCESSORY HAS BEEN PERFORMED IN ACCORDANCE TO THE
APPROPRIATE IEC 60601-1 AND/OR IEC 60601-2-26 HARMONIZED
NATIONAL STANDARD.
WHEN CONNECTING EXTERNAL EQUIPMENT (e.g., DATA CAPTURE
COMPUTER), THE SYSTEM LEAKAGE CURRENT MUST BE CHECKED
AND MUST BE LESS THAN THE IEC 60601-1 LIMIT.
EXPLOSION HAZARD: DO NOT USE THE BIS VISTA SYSTEM IN A
FLAMMABLE ATMOSPHERE OR WHERE CONCENTRATIONS OF
FLAMMABLE ANESTHETICS MAY OCCUR.
MONITOR IS NOT DESIGNED FOR USE IN MRI ENVIRONMENT.