DATREND Systems vPad-Mini, Руководство по эксплуатации

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vPad-Mini OPERATORS MANUAL
4.4 Testing Applied Parts
Many medical devices have applied parts consisting of one or more leads used to connect to the patient and
acquire a signal for a given parameter or function such as ECG. Applied parts are designated as:
a) Type B if they are applied to an external body part (does not break the skin or enter the body
cavity) and include a ground/protective earth connection to make the measurement;
b) Type BF if the measurement function is similar to a Type B but is powered by an
isolated/floating power supply (no direct ground connection); and,
c) Type CF if the measurement function has one or more lead that is intended to make direct
contact with the heart. In many case, the manufacturer will include leads of measurement functions
that require breaking the skin or entering the body cavity as a designated CF type applied part in
their specification.
The IEC61010 standard is for laboratory devices which are not intended to come in contact with a patient.
This type of device does not have applied parts.
The IEC 62353 standard calls for all leads of each Applied Part (by function) to be connected together and
each Applied Part then subjected to a Mains on Applied Part test. This is repeated for each Applied Part
function for each Applied Part Type. The test limits as identified in Table 2 of the standard are applied.
In addition to the test as described above for IEC 62353, the AU/NZ 3551 standard calls for Applied Part
to Ground tests for ALL leads (of all functions) of an individual Applied Part Type (B, BF or CF). If the
test of ALL leads fails, each function of that Applied Part must then be tested individually. The limits for
ALL leads of all functions are identical to the limits for ALL leads of EACH function.
When an Applied Part to Ground test (AU/NZ 3551) is encountered, the user will be prompted to connect
the leads according to the requirements of the standard.
Figure 59
Operation/Chapter 4
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