Preparing the Product for Use
15
Fig. 9. DataMatrix barcode
Data Matrix is a two-dimensional matrix barcode, consisting of black and white “cells”
or modules of different brightness arranged in either a square or rectangular pattern.
The DataMatrix barcode is described in ISO/IEC 16022:2006 standard.
To decode the data on device, DataMatrix barcode can be read quickly by a barcode
reader or by the smartphone camera as a two-dimensional image.
2.
Preparing the Product for Use
2.1. Requirements to Personnel
The mounting and setting of the system should be carried out by the person
empowered by the manufacturer or technical personnel of the medical institution
where the system is to be used. Remember, that accurate mounting of the system
defines its safety and operation quality. Further, the important requirements
for the mounting and setting of the system will be marked by
bold and italic fonts
.
2.2. System Placement
Before mounting and setting the digital system, select a place for it taking into
consideration the power wiring and protective ground in the room and follow
the requirements and recommendations listed below.
Requirements concerning the room selection and placement of equipment:
·
The recommended distance from the electronic unit to the short-wave or microwave
therapeutic equipment is not less than 5 meters.
·
The patient environment (within 1.5 meters) should contain only
the electronic unit being the medical device with the required safety level.
The fact is that the safety level of the computer equipment is insufficient
for the use in the patient environment. Hence, a patient must not contact with
the metal parts of computer equipment cases and the personnel must
not touch simultaneously these parts and patient body. If the computer
equipment used in the system corresponds to EN 60601-1 or is connected via
the isolation transformer corresponding to EN 60601-1, and the isolation from
the computer network is provided via the special isolation device
corresponding to EN 60601-1, then it is not obligatory to fulfill this
requirement.