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Classification and Intended Use
The unit is designed for displaying data such as patient information inside and outside of operating theaters, intensi-
ve-care wards and similar areas of application. It is intended to assist a signal source device without a display or as its
alternative display.
Following Section 6 of DIN EN 60601-1:2013 the unit is classified as below:
6.2
protective class I unit
6.3
see IP label on your unit, depending on your model IP20 or IP31
An optional IP54 upgrade is available on request for all models.
6.4
This unit is not intended for sterilization.
6.5
It is not intended for operating in an environment with enriched oxygen.
6.6
This unit is suited for permanent operation.
Third-party equipment may be connected in consideration of the restrictions in section 3.1.
The unit is considered as professional ME-Equip according to DIN EN 60601-1-2:2016, paragraph 3.23.
It not is allowed to simultaneously touch the patient and pins of signal input/output components when connecting the
unit to other devices.
The unit can be used within the patient environment.
This unit is not suited to be used in direct contact with the patient.
The patient is not supposed to operate or maintain the unit.
Furthermore, it is not allowed to use this unit in private households.
The unit is not protected against explosions.
Only instructed expert personnel may install, operate and maintain the unit.
There is no information required for activities that should avert damage to humans, animals or environment.
Summary of Contents for OR-MD Series
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