Operation Manual

08/ 2012 47 / 58

BENNING ST 750 A
and the protective contact of the mains plug or appliance plug or the protective conductor connec-
tion point of the device respectively
Electrical appliance
Device (test sample) the condition of which shall be tested with regard to electrical safety
19.2 Technical Terms according to DIN VDE 0751-1
Accessible conductive part
Any part of a medical electrical device (except for the applied part) which can be touched by the
patient or by the operator touching the patient or which might come into contact with the patient
Device leakage current
Currentowingfrommainssupplyunitstoearthviaaccessibleconductivepartsofthehousingand
via applied parts
Functional connection
Any type of connection (electrical or other) including those used for transmission of signals and/or
electric power and/or substances
Inspection
All measures taken to determine and evaluate the actual condition of the device
Medical electrical device
Electrical device which is equipped with an applied part, which serves to transfer energy to or
from the patient or which indicates such an energy transfer to or from the patient and for which the
following shall apply:
a) The device is provided with not more than one connection to a certain power supply network and
b) is intended for the following use by its manufacturer:
1) diagnosis, treatment or monitoring of a patient or
2) compensation or palliation of a disease, injury or disability
Medical electrical system
Combinationofindividualdevicesasdenedbythemanufactureramongwhichatleastonemust
be a medical electrical device and which are connected by means of a functional connection or by
using a multiple socket
Patient environment
Any kind of environment where a connection can be established intentionally or unintentionally,
namely between patients and parts of a medical electrical device or system or between a patient or
other perons touching parts of the medical electrical device or system
Patient leakage current
Currentowingfromthepatientconnectionsviathepatienttoearthorwhichiscausedbyanunin-
tendedexternalvoltageatthepatientandowsfromthepatientviathepatientconnectionsofan
applied part of type F to earth
Commissioning
Initial use of a medical electrical device or system after being installed at the responsible organi-
zation
Responsible organization
Entity responsible for the use and maintenance of a medical electrical device or system (can also
be a person)
Maintenance
Any kind of measures taken to preserve the condition of a medical electrical device or system in
compliance with the manufacturer's requirements
Applied parts
As an introduction, the different types of applied parts will be described in the following. According to
IEC 60601-1, an applied part is a part of the device which for its intended use
- necessarily comes into physical (bodily) contact with the patient so that the device can fulfil its
function or
- can be brought in contact with the patient or
- needs to be touched by the patient.
An insulated (unearthed) applied part of type F is described as:
anappliedpartwhichisisolatedfromotherpartsofthedeviceinsuchawaythatthecurrentowing
is not higher than the patient leakage current admissible for the first fault, if an unintended voltage
from an external source is connected to the patient and thus is applied between the applied part
and earth.
Applied parts of type F are either applied parts of type BF or applied parts of type CF.
Note:FordevicesofprotectionclassI,thisappliedpartisconnectedtoearthwhichcanbeveried
by measurement with an ohmmeter.
Applied part of type B:
This is an applied part which provides protection against electric shock in compliance with the re-
quirementsdenedinIEC601-1,especiallyconsideringtheadmissibleleakagecurrent,andwhich
is marked as follows:
- type B: earthed applied part or
- typeB:appliedpartprotectedbyadebrillator
Applied parts of type B are not intended for being applied directly to the heart.
Applied part of type BF:
ThisisanappliedpartoftypeFwhichprovidesamoresignicantprotectionagainstelectricshock
thanappliedpartsoftypeBincompliancewiththerequirementsdenedinIEC601-1andwhich
is marked as follows:
type BF: applied part isolated from earth or
typeBF:appliedpartprotectedbyadebrillator
Applied parts of type BF are not intended for being applied directly to the heart.
Applied part of type CF:
ThisisanappliedpartoftypeFwhichprovidesamoresignicantprotectionagainstelectricshock
thanappliedpartsoftypeBFincompliancewiththerequirementsdenedinIEC601-1andwhich
is marked as follows: