General Notes; Classification And Intended Use - Dräger OR-PC 21 Manual

1. General notes

This manual provides you with an overview of the necessary steps for commissioning and opera-
ting the computer system. Please read them even if you are familiar with the operation of compu-
ter systems.
The term "device" is used below to refer to the OR-PC
GmbH for Dräger.

2. Classification and intended use

The device is designed for documentation purposes of data, such as patient-related information
inside and outside operating rooms, intensive care units and similar areas of use. It supports the
local software environment and can be part of the IT data network.
Based on IEC 60601-1:2020, Section 6, the following classification results:
6.2 Protection class I device
6.3 IP20
6.4 The device is not intended for sterilization.
6.5 Operation in an oxygen-enriched environment is not intended.
6.6 The device is suitable for continuous operation.
When connecting devices, it is not permitted to touch the patient and the contacts of connectors
of the signal input or output parts at the same time.
The device is
• a professional ME device as defined in IEC 60601-1-2:2014, para. 3.23,
• suitable for use within the patient environment,
• not suitable for use with direct contact to the patient,
• not intended for operation or maintenance by the patient,
• not approved for use in private households,
• not equipped with fireproof enclosure features according to IEC 60601-1:2020, para. 11.2,
• not explosion-proof, and
• may only be started up, operated or serviced by qualified personnel familiar with the equipment
and this manual.
No information is required on actions to avert dangerous conditions or situations for humans,
animals or the environment.
The connection of third-party devices is permitted under consideration of the restrictions, expla-
nations and case examples cited in
4
21 or OR-PC
®
Section 3.1.
24 manufactured by ACL
®