General Requirements For A System; Preventive Maintenance Procedures; Cleaning - Philips M1013A IntelliVue G1 Service Manual

4 Testing and Maintenance

General Requirements for a System

After installation or subsequent modification, a system must comply with the requirements of the
system standard IEC/EN 60601-1-1 or IEC 60601-1 edition 3 clause 16. Compliance is checked by
inspection, testing or analysis, as specified in the IEC/EN 60601-1-1 or in this book.
Medical electrical equipment must comply with the requirements of the general standard IEC/EN
60601-1, its relevant particular standards and specific national deviations. Non-medical electrical
equipment shall comply with IEC safety standards that are relevant to that equipment.
Relevant standards for some non-medical electrical equipment may have limits for equipment leakage
currents higher than required by the standard IEC/EN 60601-1-1 or IEC 60601-1 edition 3 clause 16.
These higher limits are acceptable only outside the patient environment. It is essential to reduce
equipment leakage currents to values specified in IEC/EN 60601-1 when non-medical electrical
equipment is to be used within the patient environment.

Preventive Maintenance Procedures

Failure to implement a satisfactory maintenance schedule by the individual, hospital or institution
WARNING
responsible for the operation of this equipment may cause equipment failure and possible health
hazards.
The following sections describe the Preventive Maintenance tasks (PMs) required to keep the gas
analyzer in good working order. PMs are performed to a timetable before problems arise as a means to
reduce failures.
Take precautions when dealing with potentially contaminated parts, such as tubing and other
CAUTION
components of the patient circuit. Wear gloves, mask and gown while handling components that come
into contact with the patient's exhalant gas or fluids.
Here is a list of the PM tasks required to ensure satisfactory operation of the gas analyzer within its
specified limits and how often they must be performed.
• Check the fan filter for occlusions every 6 months.
• Check the fan in the gas analyzer for proper operation every 6 months.
• Check the gas analyzer's accuracy at least once every 12 months, or whenever the validity of the
readings is in doubt.
• Replace the PM parts every 12 months.
Check electrical safety (ground impedance and enclosure leakage current test) at least every 12 months
or every time the device is removed and reinstalled.

Cleaning

The user should be encouraged to periodically clean the exterior casing of the gas analyzer. The outside
of the gas sample tubing should be cleaned before connecting to the next patient.
52
Preventive Maintenance Procedures