Hitachi Aloka Medical ASU-1003, Instruction Manual, Page: 39 / 44

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MN1-5008 Rev. 7
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, Aloka trained service personnel can conduct a test at
the user’s expense. Contact one of our offices and/or distributor's offices listed 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 insertion portion and handle 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 insertion portion and handle 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.
Item Normal condition Single fault condition
(1) Patient leakage current from the patient
connection to earth
DC
AC
10 µA or less
100 µA or less
50 µA or less
500 µA or less
(2) Patient leakage current caused by an
external voltage on the patient connection
of an F-type applied part
5000 µA or less
Table. Standard Values for Periodic Safety tests
(Extract from IEC 60601-1:2005)
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.