DATREND Systems ES601-US, Operating Manual

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ES601-US OPERATING MANUAL
ES601pc-US Software/Chapter 8
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Page 156
8.6.17 Patient leads (all standards except IEC61010)
This test is enabled by checking the "Patient Leads" box, unless the safety standard is one of the "-BAT"
standards, in which case this test is always enabled. In this test, ES601-US measures the current that flows
out of the patient leads of the DUT through the human body load, when the parts are either connected to
ground, or they are connected to an isolated AC supply. This latter test is referred to as a lead isolation test
or "mains-on-applied-part" (MAP) test. Under the IEC60601 standard, the MAP voltage equals 110% of
the AC supply voltage to the DUT; for all other standards the MAP voltage is equal to the AC supply
voltage. For the "-BAT" standards, patient-patient leads must be isolated from ground (Type BF or Type
CF under AAMI-BAT and IEC601-BAT; or Type F under VDE-BAT or IEC353-BAT).
8.6.18 Patient Lead Groups (all standards except IEC61010)
A Group of patient leads consists of one to ten contiguous ECG or other patient leads. Also, Groups
encompass the patient leads in order, starting from patient lead 1 (AP1). For example, Group 1 may consist
of patient leads #1 to #3, Group 2 may consist of patient leads #4 to #5, and Group 3 may consist of
patient lead #6. In all but the AAMI Standard, Group 1 is always enabled and has at least 1 patient lead.
The patient lead editor is accessed by clicking on the patient leads tab. The patient leads tab will be
accessible only if Leakage Current is enabled and one of "Patient Leads" or "Lead-to-Lead Leakages" is
selected. After clicking the Patient Leads tab, a Group of leads can be enabled by either checking the Group
checkbox, or by entering a non-zero number of patient leads for that Group. The patient lead Names and
Status panel will display the patient leads that have been enabled. A name can be given to the patient lead
Group by editing the Name textbox.
A Patient Lead Group may be disabled after entering a non-zero number of patient leads for that Group.
The disabled Group will then separate the enabled Groups on the front panel connections to the analyzer.
The type of protection class can be changed by selecting either the B, BF or CF radio button. In the AAMI-
ES1 and AAMI-Battery Standards, Group 1 always has a protection class of "Isolated", which corresponds
to "Body-Floating"; and Group 2 always has a protection class of "Non-Isolated", which corresponds to
"Body".
Type B refers to "Body" or "Non-Isolated" protection class. That is, the patient leads are not electrically
isolated from ground. Type B parts have the least stringent safety requirements. ES601-US will measure
patient leakage current while all the Type B patient leads in the patient lead Group are shorted to ground.
Type BF refers to "Body-Floating" or "Isolated" protection class. That is, the patient leads are electrically
isolated from ground but are not intended for direct contact with cardiac tissue. ES601-US will measure
patient leakage current while all the patient leads in the Type BF patient lead Group are shorted to ground,
or alternatively to the isolated mains (AC supply).