Zoom USB External Manual do Utilizador descarregar pdf (Página 3)

May 15, 2013 002-1362, Rev. D, US Page 3 of 3

Frequently Asked Questions

Does printing to an external printer meet electrical safety standards?

Boston Scientific Instructions for Use include the following precaution regarding optional external equipment (e.g.,

printers):

PRECAUTION: Although any optional external equipment connected to the programmer meets leakage-current

requirements for commercial products, it may not meet the more stringent leakage requirements for medical products.

Consequently, the external printing equipment must be kept outside the patient environment (at least 1.5 m [4.9 feet]

away from the patient). (Operator’s Manual ZOOM LATITUDE PRM 357435-094 EN).

Additionally, equipment connected to the external connections must comply with applicable standards (e.g., IEC/EN

60950-1 for data processing equipment and IEC/EN 60601-1 for medical equipment).

WARNING: The use of any cables or accessories with the programmer other than those specified by Boston Scientific

in the Instructions for Use (IFU) may result in increased emissions or decreased immunity of the programmer. Anyone

connecting such cables or accessories to the programmer may be configuring a medical system and is responsible to

ensure that the system complies with the requirements of IEC/EN 60601-1, Clause 16 for medical electrical systems

If you require further assistance, contact Boston Scientific Technical Services.

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