EN
1.2 Usage Restrictions and Limitations
This device and the accessories have been built and sold exclusively for the intended purposes mentioned
above.
The measured values serve for monitoring purposes only. They are explicitly not intended for the control of
performance of medical devices or vital physiological parameters, the variation of which would lead to an
immediate hazard for the patient.
For the control or monitoring of such vital physiological parameters, it is essential to use other medical
methods for diagnosis, such as ultrasound techniques or perfusion measurements.
It is the operator’s responsibility to use the device as described in the operating instructions and in any of its
following revisions. The use of clinical procedures and techniques lies in the physician’s area of responsibility.
•
A zero flow adjustment must be carried out before each measurement to avoid
possible offsets from the measured values. The sensor must be clamped in the correct
installation position at the location intended for it. The tube must be filled with liquid
but the liquid must not move. Ensure that no air bubbles are in the tube during the zero
flow adjustment. Allow sufficient time for the system to adapt to ambient conditions.
Only then is the system ready for measurement.
•
If the SonoTT
TM
Ultrasonic FlowComputer is not used as intended, the user may be
exposed to risks that were not taken into account during its development.
•
Decisions regarding therapeutic methods must not be solely based on the measured
flow data.
The values issued by this device have to always be verified with other methods before
any decisions regarding treatment are made.
1.3 Liabilities and Responsibilities
The manufacturer is only responsible for safety, reliability and usability of the device if:
•
the device is used according to the operating instructions.
•
the electrical installation in the room of use complies with the requirements of the
IEC 60364-7-710 1
st
ed.
or equivalent national or international standards.
•
installation, enhancements, new settings, changes or repairs and maintenance are made by personnel
authorized and trained by the manufacturer.
The user is responsible to use, check and maintain the SonoTT
TM
Ultrasonic FlowComputer and the SonoTT
TM
Clamp-On Transducer according to these operating instructions.
Consequently, em-tec GmbH is neither liable nor responsible for any consequences arising from the use
of the SonoTT
TM
Ultrasonic FlowComputer and SonoTT
TM
Clamp-On Transducer that do not comply with the
operating instructions or specifications in this manual.
SonoTT
TM
Ultrasonic FlowComputer
Copyright em-tec GmbH
D108-702 SonoTT
TM
Ultrasonic FlowComputer - Operating Instructions V4.0
•
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