em-tec SonoTT, Operating Instructions Manual

Page: 8 / 52

EN
4 General Information Concerning these Operating Instructions
• Read these operating instructions carefully before starting up the system!
→ This document is intended for the SonoTT
TM
Clamp-On Transducer and describes
the use of the SonoTT
TM
Clamp-On Transducer in combination with the
SonoTT
TM
Ultrasonic FlowComputer.
• The user (= the person who connects the SonoTT
TM
Clamp-On Transducer to
the tubing circuit and measurement system) is responsible for any risk if the
SonoTT
TM
Clamp-On Transducer is not connected correctly.
• Inspect your SonoTT
TM
Clamp-On Transducer for completeness and damage when unpacking
it for the first time.
• The customer must ensure that the persons involved in the integration and use of the
SonoTT
TM
Clamp-On Transducer and the system it is part of are adequately qualified. In
addition, the information in these operating instructions must be followed.
• Do not drop the SonoTT
TM
Clamp-On Transducer. It might break or become damaged, which
could impair the measurement.
These instructions contain important information concerning the safe and correct handling of the
SonoTT
TM
Clamp-On Transducer. Read these operating instructions carefully before using the product and 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
Clamp-On Transducer 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.
5 Intended Purpose, Restrictions and Limitations
5.1 Intended Purpose
The SonoTT
TM
Clamp-On Transducer (in combination with a SonoTT
TM
Ultrasonic FlowComputer) is indicated for
the bi-directional volumetric measurement of the liquid flowing through tubing systems. The measurement
principle is the ultrasound transit-time method.
The medical use of the device is appropriate for extracorporeal applications together with the
SonoTT
TM
Ultrasonic FlowComputer such as:
• cardio-pulmonary bypass, hemodialysis, hemofiltration, plasmapheresis
• ECMO (ExtraCorporeal Membrane Oxygenation) applications
• perfusion, infusion, transfusion
• several shunt-applications
Intended Users of the SonoTT
TM
Clamp-On Transducer
For reasons of patient safety, the device may only be used by qualified and trained medical professionals.
SonoTT
TM
Clamp-On Transducer
Page 8 D162-700 SonoTT
TM
Clamp-On Transducer - Operating Instructions V3.0 Copyright em-tec GmbH