Baaske e-medic Manual - 2. Patient Environment
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2. Patient environment
To protect your patients from electrical influences avoid simultaneous contact with the
patients and the computer housing.
a) e-medic Pro-Line M II Computer (Medical)
The Pro-Line M II is a so called „Medical PC“ and was developed and tested for use in the
vicinity of patients. It fulfils the requirements of the EN/IEC 60950 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.
b) e-medic Pro-Line II Computer
Pro-Line II model computers are only appropriate for use in the vicinity of patients in
conjunction with a medical isolating transformer. The output of the isolating transformer
should be at least 450VA. We recommend the use of the MED N isolating transformers
that can be sourced through your e-medic dealer. In this configuration a faultless function
is guaranteed. In the following table you can find an overview of recommended isolating
transformers.
Recommended isolating transformers for Pro-Line II
Output
Model name
600VA
MED N 600 VA
1000VA
MED N 1000 VA
2000VA
MED N 2000 VA
Electrical safety according to IEC / EN 60601-1
For the manufacture of a system consisting of computers of the Pro-Line (M) II series and
other electrical devices used in the medical field, the requirements of the valid version of
IEC / EN 60601-1 resp. EN 60601-1-1 are to be taken into account.
Furthermore, it is the responsibility of the system manufacturer to market the complete
system according to the medical product guidelines 93/42 EWG resp. 2007/47/EG and,
as the case may be, to bring it into operation in the framework of in-house production
according to §12 MPG. Because by definition a computer system without medical software
cannot be a medical product as defined by the guidelines of 93/42 EWG it is, therefore, a
new system made up of medical product and non-medical product.
Isolating transformer MED N 600 VA 230V