Installation, Inspection and Maintenance
4-5
Inspect whether the input and output ports are loose.
4.2.7 Regular safety inspection
The following safety inspections should be carried out by an experienced, well-trained
qualified person at least every 24 months:
z Inspect if the equipment and the accessories are damaged in mechanics and
functions.
z Inspect if the relevant safety labels are clear for identification.
z Ensure that all functions of the equipment meet their operation instructions.
z Inspect the patient leakage current according to the requirement of IEC 60601.
The leakage current shall not exceed the maximal limit. All data shall be recorded in the
system log. If the system does not work properly or pass any of the above tests, the
system shall be repaired.
4.2.8 Inspection on consumables
The items listed below are consumables. Please check regularly to replenish or replace
them in time.
Table 4-1 List of consumables and tips for replenish/replacement
Item When to replenish/replace
Ultrasound gel Running out
Control key Wobbled or swayed, noticeable
Dust cover Worn or torn
Probe Abnormal appearance of connector or cable
Note: No coupling gel is supplied with the system when it is delivered from the
factory. The user shall purchase the required coupling gel that complies
with regulations of the country where the system is installed. It is
recommended to use coupling gel conforming to ISO 10993 requirements.
4.2.9 Probe cleaning and sterilization
The probe should be cleaned and sterilized every time after it is in use.
Please follow the conditions below when cleaning and sterilizing the probe, otherwise the
probe may be damaged.
a) The probe should not be cleaned or sterilized with alcohol, cleanser containing
alcohol or other organic solvent (e.g. thinner);
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