1-8 Cardiolab® II Plus Amplifier Manual 2002938-002E
Introduction
Type CF equipment is specifically designed for applications where a
conductive connection to the heart is directly established.
Type CF Equipment
Type CF equipment that is defibrillator proof.
Isolated (floating) applied part suitable for intentional external and
internal application to the patient including direct cardiac application.
“Paddles” outside the box indicate the applied part is defibrillator proof.
[Medical Standard Definition:] F-type applied part (floating/isolated)
complying with the specified requirements of IEC 60601-1/UL 2601-1/
CSA 601.1. Medical Standards to provide a higher degree of protection
against electric shock than that provided by BF applied parts.
Equipotentiality
A nonessential electrical connection which may be used to connect the
chassis to other equipment to achieve the same potential.
Classifications
The CardioLab II Plus Amplifier is classified, according to IEC-60601-1,
as:
Type of protection against electrical shock I
Degree of protection against electrical
shock
CF—ECG, BP, CIM, Auxiliary Inputs
Degree of protection against harmful
ingress of water
Ordinary
Degree of safety of application in the
presence of a flammable anesthetic
mixture with air or with oxygen or nitrous
oxide
Not suitable
Method(s) of sterilization or disinfection
recommended by the manufacturer
Not Applicable
Mode of operation Continuous operation
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