User manual

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measurement accuracy. Another requirement stems from the standard ČSN EN 60601-1,
which deals with electrical safety, both from the point of view of the attending staff, and of
the patient. It is namely an inspection of the device’s insulation state, in order to prevent
possible injury by the electrical current. The contents of the above mentioned legislation will
be described in greater detail in the text below.
Law No. 123/2000 Coll. on medical devices and on changing some related laws.
Among other things, it determines the basic requirements for maintaining medical devices
throughout their technical life.
Conditions for using the medical devices are stated in Chapter 4. Medical devices must
meet the technical parameters given by the manufacturer throughout the period of use. The
law in this respect forbids using the MD if there is a reasonable suspicion that the safety and
lives of users or third persons are endangered, or if their usable life determined by the
manufacturers or importers has expired.
According to Chapter 24, health care providers are obliged to adopt such measures in
medical devices with measuring functions that will guarantee sufficient accuracy and
reliability of measuring. The provider thus must guarantee meeting the conditions ensuing
from the Law on metrology No. 505/1990 Coll., as amended. In case of assigned gauges, this
means their verification within the statute of limitation, and in case of assigned gauges, it is
necessary to keep their calibration within the time limits recommended by the manufacturer.
Periodical safety-technical checks of medical devices are specified in Chapter 27. The
Ministry of Health may determine the types or classes of MD to be periodically checked by a
public notice. Here the term “periodical safety-technical check” appears, abbreviated to
PSTC. This chapter directly orders to maintain the safety of MD, in our case specifically the
electrical safety of the medical device, its function, i.e. the requirement for the medical device
to reach technical parameters set in the manufacturer’s technical specification. These two
requirements cannot be separated from each other.
Last but not least, specification of the maintenance and service of the medical devices
is described in Chapter 28.
Medical devices must be, in accordance with the manufacturer’s instructions,
professionally, repetitively, and demonstrably kept in such a state by treatment and regular
checks to guarantee their functioning and safety throughout their usable life. PSTC and
service may only be carried out by a person with professional training, experience, knowledge
of legal regulations and technical standards, and completed training.
Other standards regarding the safety of MD:
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