User manual

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Just like any medical device, also the patient monitors and their utilization are subject
to valid legislation. STC (safety-technical check), which ensues from the Law No. 123/2000
Coll., particularly from Chapter 27 thereof, is one of the most frequent activities of a
biomedical technician in the healthcare facility. STCs stem from the necessity to check and
verify the parameters of the medical instrumentation throughout their clinical operation. This
concerns the devices in which there is a potential risk of damaging the patient’s health in case
of impaired function or measurement accuracy. Another requirement stems from the standard
ČSN EN 60601-1, which concerns electrical safety from the point of view of both the
attending staff and the patient. It is namely the check of the apparatus’ insulation status in
order to prevent the possible injury by electrical current. In the text below, the contents of the
above mentioned legislation will be described in greater detail.
Fig. 8.1: Overall view of the patient monitor, display showing the individual courses
with a possibility of their selection (today often a touch screen).
Law No. 123/2000 Coll. on medical devices and on changing some related laws.
Among other things, it determines the basic requirements on maintaining the medical devices
throughout their technical life.
The conditions for using medical devices are mentioned in Chapter 4. Medical devices
must meet the medical and technical parameters given by the manufacturer throughout their
life. The law in this respect forbids the use of the MD in case there is a reasonable suspicion
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