2
1. General notes
This manual provides an overview of the necessary steps for commissioning and operating the
computer. Read it even if you are familiar with the operation of computer systems.
We will use the term “unit” to designate the OR-PC
®
xx model manufactured by ACL GmbH, where
xx describes the display size between 15 to 55 inches.
2. Classification and intended use
The unit is designed for documenting data such as patient information inside and outside of
operating theaters, intensive-care wards and similar areas of application. It supports the local
software environment and may be part of the IT network.
Following section 6 of IEC 60601-1 the unit is classified as:
6.2 protective class I,
6.4 not intended for sterilization,
6.5 not intended for operation in an environment with enriched oxygen (>25% @ 110kPa),
6.6 suited for continuous operation.
6.3 No IP classification acc. to IEC 60529 has been specified for your configuration. An IP54 up
grade is available upon request and would, if applicable, include an IP-marking on the
housing.
The front part of your unit is protected according to IP65.
It’s not allowed to simultaneously touch the patient and the interfaces.
The unit can be used within the patient environment.
This unit is not intended to be used in direct contact with the patient.
The unit is neither intended to be operated nor maintained by the patient.
Because the exact medical functionality is not defined yet IEC 60601-1-11 has not been considered
for this unit yet. However, integration into a system for use in private households is not impossib-
le. Details can be found in section 3.3.
The unit is not categorized as AP or APG equipment acc. Annex G of IEC 60601-1.
Only qualified personnel, which is familiar with the unit and its manual, may install, operate and
maintain the unit.
Third-party devices may be connected in consideration of the restrictions in section 3.1.
To Next Page
Loading...
Need help?
General