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8. Periodic Inspection
8-1. Safety tests
The safety tests should be conducted at least once a year by a qualified technician. The test record should be
stored for future reference.
Remarks 1
Qualified technician: personnel for conducting safety tests of medical electrical equipment.
If the user requires an appropriate qualified technician, service personnel trained by us can conduct a test at
the user's expense. Contact one of our office written on the back cover.
Remarks 2
Make a copy of the Safety Inspection Data Sheet provided in the instruction manual of the ultrasound
diagnostic instrument. Use the sheet as a test record.
Procedure for periodic safety tests and judgment
(1) Test of patient leakage current from the patient connection to earth
Using the measuring instruments which usable to the requirement of IEC 60601-1 :2005, conduct the test
as shown in Fig. 15 of IEC 60601-1 :2005.
Soak the scanner tip in saline solution and measure the leakage current between the applied part and earth.
Do not soak scanners in saline solution beyond the "IPX7 range" provided in section 2-2.
(2) Test of patient leakage current caused by an external voltage on the patient connection of an F-type applied
part.
Using the measuring instruments which usable to the requirement of IEC 60601-1 :2005, conduct the test
as shown in Fig. 16 of IEC 60601-1 :2005.
Soak the scanner tip in saline solution and measure the leakage current between the applied part and earth.
Do not soak scanners in saline solution beyond the "IPX7 range" provided in section 2-2.
(1) Patient leakage current from the patient con-
nection to earth
DC
AC
(2) Patient leakage current caused by an
external voltage on the patient connection of
an F-type applied part
Warning
Perform a safety tests at least once a year and keep a record of the inspection results.
Failure to notice an abnormal condition while using the scanner can result in injury to the operator or
patient. If an inspection finds an abnormal condition in the scanner, immediately stop use and contact
one of our offices and/or distributor's offices listed on the back cover.
Item
Table. Standard Values for Periodic Safety tests
(Extract from IEC 60601-1 :2005)
-35-
Normal condition Single fault condition
10 µA or less
100 µA or less
500 µA or less
5000 µA or less
MN1-5933 Rev.5
50 µA or less
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