EN
Intended Patients of the SonoTT
TM
Clamp-On Transducer
The product is intended for the following patient population:
•
patients who are undergoing a surgery, supervised by medically trained personnel.
•
patients who are connected to an extracorporeal circulation system such as an ECMO device.
•
patients who are treated within an hospital environment, e.g. an intensive care unit or operating room.
The product is not intended for the direct use on patients and should not come into direct contact with
them. In situations where skin contact cannot be ruled out or avoided, a pad, e.g. a gauze, should be placed
between the skin and the sensor.
A malfunction of the device is causing no additional health risk to the patient.
Intended Environment of the SonoTT
TM
Clamp-On Transducer
The SonoTT
TM
Clamp-On Transducer is designed for the continuous operation in intensive care units, operating
rooms and similar medical environments.
Clinical Benefits
Additional information for the attenting physician on the flow behavior of liquids in a patient-bound tubing
system.
The expected lifetime of the device is ten years.
5.2 Contraindications
This device and the accessories have been built and sold exclusively for the intended purpose mentioned
above.
The SonoTT
TM
Clamp-On Transducer and the SonoTT
TM
Ultrasonic FlowComputer are explicitly
not intended
–
to allow direct diagnosis or monitoring of vital physiological processes.
–
for the monitoring of vital physiological parameters, where the variation could result in immediate
danger to the patient, for instance variations in cardiac performance, respiration, activity of the central
nervous system.
–
as sole base for decisions regarding therapeutic methods. The values issued by this device have to
always be verified with other methods before any decisions regarding treatment are made.
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.
5.3 Usage Restrictions and Limitations
The SonoTT
TM
Clamp-On Transducer is explicitly
not intended
–
for the use outside of medical environments.
–
for the use inside means of medical transport (e.g. ambulance car or helicopter).
SonoTT
TM
Clamp-On Transducer
Copyright em-tec GmbH
D162-700 SonoTT
TM
Clamp-On Transducer - Operating Instructions V3.0
Page 9
Summary of Contents for SonoTT
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