Patient Environment; E-Medic™ Computer; Electrical Safety According To En / Iec 60601-1 - Baaske Medical e-medic Silence XT-M Handbuch

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2. Patient environment

To protect your patients from electrical influences avoid simultaneous contact with
the patients and the computer housing. The e-medic™ 60601-1 is a so called „Medical
Computer" and was developed and tested for use in the vicinity of patients. It fulfils
the requirements of the EN / IEC 62368-1 and EN / IEC 60601-1-2 standards and the
power supply fulfils the requirements of EN / IEC 60601-1 standard with respect to
the electrical limit values.
The e-medic™ office Computer is only suitable in conjunction with a medical
isolating transformer for the patient environment. The output power of the
isolation transformer should be at least 150 VA.

Electrical safety according to EN / IEC 60601-1

For the manufacture of a system consisting of computers of the e-medic™ compu-
ter series and other electrical devices used in the medical field, the requirements of
the valid version of EN / IEC 60601-1 resp. EN / IEC 60601-1-2 are to be taken into
account.
Furthermore, the system manufacturer is responsible to market the complete system
according to the Regulation (EU) 2017/745 (MDR) on medical devices and, as the
case may be, to bring it into operation in the framework of in-house production.
Because a computer system without medical software cannot be a medical product
as defined by the guidelines of Regulation (EU) 2017/745 on medical devices it is,
therefore, a new system made up of medical product and non-medical product.
The e-medic™ computer was certified according to EN / IEC 60601-1-2 and the power
supply meets the requirements according to EN / IEC 60601-1.
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