AREA OF USE AND SAFETY
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SICAT JMT
⁺
Jaw Motion Analysis System
OBLIGATIONS OF THE USER
■ The general guidelines and/or national legislation, national regulations and technical regulations
pertaining to medical products are to be applied and fulfilled both with the start-up and during the
operation of the SICAT product appropriate to the stated purpose. In Germany, operators, those
responsible for such devices, and users are obliged to operate their devices in compliance with the
MPG (Medical Devices Act) regulations.
■ It is the obligation of the user:
– to comply with all the safety instructions stated in the operating instructions.
– to carry out all of the inspection and maintenance work regularly as specified in the operating
instructions.
– to only use fault free working equipment.
– to ensure that the device is functionally safe and in a proper state prior to every instance of use of
the device.
– to ensure all the provided operating instructions that form part of the measurement system, are
accessible to all users at all time, and to keep them near the measurement system.
– to protect oneself, the patients and third parties against dangers.
– to prevent a contamination occurring due to the product.
■ During use, it is necessary to comply with the legal regulations, especially:
– the current work safety regulations.
– the current accident prevention measures.
■ Responsibility is assumed to ensure the safety, reliability and effective performance of all
measurement systems and accessories delivered by SICAT, such that:
– assembly work, extensions, new settings, changes or repairs are carried out by SICAT or third
parties authorized by SICAT, trained technicians or by the personnel of authorized dealers. The
storage and transport should only be carried out in the original packaging, as provided by the
manufacturer.
– the product is operated in compliance with the operating instructions.
– the information technology components provided by the operator comply with the technical
requirements for hardware and software contained in these operating instructions, and that they
are installed and set up according to the applicable descriptions for these components.
– the place of installation corresponds with the specified environmental conditions for the
measurement system and the current installation regulations.
– only the software made available by SICAT, as well as the components and accessory parts listed
in these operating instructions are used with the system.
GENERAL SAFETY INFORMATION
■ The use and operation of the system and the evaluation of measurement data and its interpretation
should only be carried out by trained specialist personnel. The manufacturer assumes no liability for
damage to persons or property, or the loss of data that may occur due to the improper use of the
software, the device, or its accessory parts.
■ Patients and measurement data may only be copied, moved or deleted with the help of the database
function that is provided by the SICAT applications programs. In the case of the deliberate changing
of data without the database functions, the user alone bears the full risk.
■ All measurement and/or analysis results should always be interpreted by a trained specialist and
checked for their relevance in consideration of the clinical medical history of the patient and in the
context of the further diagnostic procedure. If invasive measures are taken, the measurement system
2.2.3
2.2.4
