EN
•
Read these operating instructions carefully before starting up the system!
This document is intended for the SonoTT
TM
Ultrasonic FlowComputer. It describes the use
of the SonoTT
TM
Ultrasonic FlowComputer.
•
The operator (=the person using the SonoTT
TM
Ultrasonic FlowComputer) is responsible
for any risk if the SonoTT
TM
Ultrasonic FlowComputer is not used according to its intended
purpose or if these operating instructions are not abided by.
•
Inspect your device and its accessories for completeness and damage when unpacking it for
the first time.
•
The customer must ensure that the persons involved in using the SonoTT
TM
Ultrasonic
FlowComputer are adequately certified. In addition, the information in these operating
instructions must be followed.
These instructions contain important information concerning the safe handling of the
SonoTT
TM
Ultrasonic FlowComputer and its accessories. Keep them in an easily accessible location. Familiarize
yourself with all warning and safety information and observe them. It is the responsibility of the operator to
ensure that the SonoTT
TM
Ultrasonic FlowComputer is used, inspected and maintained in accordance with the
operating instructions. This also applies for all subsequent revisions or instructions from the manufacturer. The
manufacturer reserves the right to modify technical data without prior notice.
Upon request, em-tec GmbH will provide additional information in regard to the installation and integration
of the SonoTT
TM
Ultrasonic FlowComputer into your application.
1
Intended Purpose, Restrictions, and Limitations
1.1
Intended Purpose
The SonoTT
TM
Ultrasonic FlowComputer is indicated for the bi-directional volumetric measurement of
the liquid flowing through tubing systems (in combination with a SonoTT
TM
Clamp-On Transducer). The
measurement principle is the ultrasound transit-time method.
The medical use of the device is appropriate to procedures such as the following:
•
extracorporeal application with SonoTT
TM
Clamp-On Transducer:
–
cardio-pulmonary bypass, membrane-oxygenation, haemodialysis, haemofiltration, plasmapheresis
–
perfusion, infusion, transfusion
–
several shunt-applications
The SonoTT
TM
Ultrasonic FlowComputer is designed for the continuous operation in intensive care units and
operating rooms. For the patient’s safety, the device must be operated by qualified clinical users only.
An adequate set-up procedure prior to the application should be implemented in the medical facility to
ensure that the flow meter and the connected SonoTT
TM
Clamp-On Transducer and/or the blood pressure
transducers are installed correctly and function as intended. The alarm and measurement settings, including
the zeroing of flow must, of course, be correct as well. The user information provided for the accessories
indicated above have to be followed as well if they are relevant and applicable.
SonoTT
TM
Ultrasonic FlowComputer
Page 52
D108-702 SonoTT
TM
Ultrasonic FlowComputer - Operating Instructions V4.0
Copyright em-tec GmbH