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4
4
Testing and Maintenance
Introduction
This chapter provides a checklist of the testing and maintenance procedures to ensure the performance
and safety of the IntelliVue G1/G5.
These tests must be performed only by qualified personnel certified by the responsible organization.
Qualifications required are: training on the subject, knowledge, experience and acquaintance with the
relevant technologies, standards and local regulations. The personnel assessing safety must be able to
recognize possible consequences and risks arising from non-conforming equipment.
All recurring safety and performance assurance tests must be performed under equal environmental
conditions to be comparable.
Preventive Maintenance refers specifically to the series of tests required to make sure the measurement
results are accurate. The accuracy and performance procedures are designed to be completed as
specified in the following sections or when readings are in question.
For detailed instructions on the maintenance and cleaning of the G1/G5 and its accessories, see Care
and Cleaning and Maintenance and Troubleshooting in the G1/G5 Instructions for Use.
Terminology and Definitions
The following terms and definitions are used throughout this chapter and taken from the international
standards IEC 60601-1, IEC 60601-1-1 and IEC 62353.
•
Medical System:
a medical electrical system is a combination of at least one medical electrical device
and other electrical equipment, interconnected by functional connection or use of a multiple
portable socket-outlet.
•
Patient Environment:
any area in which intentional or unintentional contact can occur between the
patient and parts of the medical system or between the patient and other persons who have had
contact with parts of the medical system. The patient environment is defined anywhere within 1.5m
(5 feet) of the perimeter of the patient's bed and 2.5m (8.2 feet) from the floor.
•
Separation Device/Transformer:
a component or arrangement of components with input parts and
output parts that, for safety reasons, prevent a transfer of unwanted voltage or current between parts
of a medical system.
•
Multiple Portable Socket-Outlet:
a combination of two or more socket-outlets intended to be
connected to or integrated with flexible cables or cords, which can easily be moved from one place to
another while connected to the power mains.
