Emtec SonoTT Manuale utente

SonoTTTM Clamp-On Transducer

Operating Instructions

These operating instructions or any part thereof must not be reproduced, saved, processed, duplicated or

distributed without the written consent of em-tec GmbH.

Subject to Technical Changes

Owing to our policy of continuous product development, the illustrations and technical data contained in

this document may differ slightly from the current version of the device.

Legal Manufacturer

em-tec GmbH

Lerchenberg 20

86923 Finning

GERMANY

Phone: +49 8806 9236-0

Fax: +49 8806 9236-50

E-mail: em-tec-info@psgdover.com

Internet: www.em-tec.de

Table of Contents

English..................................................... 5

Deutsch..................................................... 26

SonoTTTM Clamp-On Transducer

Table of Contents

1 System Description............................................................................................................5

2 Description of the Measurement Principle..................................................................6

3 General Safety Information, Symbols and Units ...................................................... 7

3.1 Symbols Used in these Operating Instructions ...................................................7

3.2 Symbols on the SonoTTTM Clamp-On Transducer and on Packaging.............7

4 General Information Concerning these Operating Instructions.............................8

5 Intended Purpose, Restrictions and Limitations.......................................................8

5.1 Intended Purpose.........................................................................................................8

5.2 Contraindications......................................................................................................... 9

5.3 Usage Restrictions and Limitations........................................................................ 9

5.4 Liabilities and Responsibilities.............................................................................. 10

5.5 Notice Concerning Compulsory Registration..................................................... 10

5.6 Safety Instructions..................................................................................................... 10

5.7 Electromagnetic Compatibility .............................................................................. 10

5.8 Ultrasonic Safety Regarding Acoustic Output.....................................................11

5.9 Biocompatibility ..........................................................................................................11

5.10 Maintenance and Service..........................................................................................12

6 Installation, Use, and Disassembly of the

SonoTTTM Clamp-On Transducer....................................................................................13

6.1 General Safety Information .....................................................................................13

6.2 Connecting the SonoTTTM Clamp-On Transducer to the

SonoTTTM Ultrasonic FlowComputer.......................................................................13

6.3 Attaching the SonoTTTM Clamp-On Transducer to the Tube........................... 14

6.4 Use of the SonoTTTM Clamp-On Transducer.........................................................15

6.5 Disassembly and Storage of the SonoTTTM Clamp-On Transducer ............ 16

6.6 Cleaning and Disinfection of the SonoTTTM Clamp-On Transducer..............17

6.7 Changing the SonoTTTM Clamp-On Transducer .................................................17

7 Adjustment and Calibration of the SonoTTTM Clamp-On Transducer...................18

7.1 Adjustment................................................................................................................... 18

7.2 Calibration ................................................................................................................... 18

8 Troubleshooting ...............................................................................................................19

9 Environmental Protection and Disposal.....................................................................22

10 TechnicalSpecicationsoftheSonoTTTM Clamp-On Transducer.........................23

SonoTTTM Clamp-On Transducer

Page 4 D162-700 SonoTTTM Clamp-On Transducer - Operating Instructions V3.0 Copyright em-tec GmbH

1 System Description

The SonoTTTM Clamp-On Transducer, which is used in combination with, and powered by, the evaluation

device SonoTTTM Ultrasonic FlowComputer, measures the volumetric ow rate of uids based on the ultrasonic

transit time method. The SonoTTTM Clamp-On Transducer encloses exible tubes via a simple click-fastening

and operates non-invasively without physical contact to the medium, allowing it to meet even strict hygienic

requirements. In combination, the SonoTTTM Clamp-On Transducer and the SonoTTTM Ultrasonic FlowComputer

represent an independent system.

Established elds of application on extracorporeal tubing circuits for the SonoTTTM Clamp-On Transducer are,

for example:

• heart-lung machines (HLM)

• extracorporeal membrane oxygenation (ECMO)

• organ perfusion

• left and right ventricular bypasses

• cardiopulmonary support/bypasses

• venous extracorporeal support (e.g. for liver transplantation)

• shunts

ClassicationunderMDR(EUDirective2017/745)

The SonoTTTM Clamp-On Transducer is assigned to MDR Class I in accordance with Annex VIII, using Rule 13.

The SonoTTTM Clamp-On Transducer is an active device used to monitor the ow in extracorporeal tubing

circuits together with the SonoTTTM Ultrasonic FlowComputer. The Declaration of Conformity for the MDR is

based on this classication.

While a copy of the current version of the CE Declaration of Conformity, including RoHS and REACH, and

a copy of the CE certicate itself are not included in these operating instructions, they are available from

em-tec GmbH upon request.

Figure 1: SonoTTTM FlowMeasurement System

SonoTTTM Clamp-On Transducer

2 Description of the Measurement Principle

The SonoTTTM Clamp-On Transducer is based on an acoustic measurement principle and utilizes the transit

time method to determine the ow. A typical transit time ow measurement system incorporates two

piezo ceramics that act as both ultrasonic transmitter and receiver. The measurement system, consisting

of the SonoTTTM Ultrasonic FlowComputer and the SonoTTTM Clamp-On Transducer, operates by alternately

transmitting and receiving an ultrasonic pulse between the piezo ceramics and measuring the transit time

difference that it takes for the pulse to travel between them.

This method determines the transit time difference of ultrasonic signals through a measuring section

and is used to estimate volumetric ow rates. There are at least two piezo ceramics required in order to

send and receive ultrasonic pulses both with and against the ow direction. For a higher accuracy, the

SonoTTTM Clamp-On Transducers incorporate two pairs of piezo ceramics, i.e. four piezo ceramics in total,

which are arranged in an X-conguration around the tube containing the measured ow.

When sending ultrasonic signals through the measuring section, the transit time difference depends on the

ow direction of the medium:

• The ultrasonic sound signals that are sent along the ow direction and volume ow of the medium, i.e.

downstream, need less time to travel the measuring section

than

• the ultrasonic sound signals that are sent against the ow direction, i.e. upstream.

Consequently, the transit time difference is measured for every pulse. The difference between upstream and

downstream measurements is proportional to the volumetric ow rate of the liquid in the tube. Therefore,

by accurately measuring the difference between upstream and downstream transit time Tup and Tdown, it is

possible to estimate the ow velocity. Subsequently, the volumetric ow rate is computed from the inner cross

section area of the tube and the instrument coefcient.

Figure 2: Sensor Structure

SonoTTTM Clamp-On Transducer

Page 6 D162-700 SonoTTTM Clamp-On Transducer - Operating Instructions V3.0 Copyright em-tec GmbH

3 General Safety Information, Symbols and Units

3.1 Symbols Used in these Operating Instructions

Symbol Meaning

Warning! This safety symbol precedes critical information that must be strictly

observed in order to prevent injuries and fatal hazards. This warning symbol is the

most important safety symbol.

Caution! Important information regarding correct handling. Must be observed and

strictly adhered to. If this information is not observed, malfunction or damage of

the product and its surroundings may occur.

3.2 Symbols on the SonoTTTM Clamp-On Transducer and on Packaging

Symbol Meaning

Read these operating instructions carefully before use. Keep them in an easily

accessible location for future reference. Replacement copies of these operating

instructions are available from the manufacturer.

Do not dispose of this device together with domestic waste!

The device as a whole as well as any parts must be disposed of in accordance with

WEEE Directive and national legislation.

Manufacturer:

em-tec GmbH · Lerchenberg 20 · 86923 Finning · Germany

Date of manufacture

Serial number

Order number

Temperature limit during storage and transport.

Moisture limit during storage and transport.

Air pressure limit

Classication Applied Part: BF according to EN 60601-1

IP67 IP (=Ingress Protection) Classication

SonoTTTM Clamp-On Transducer

4 General Information Concerning these Operating Instructions

• Read these operating instructions carefully before starting up the system!

→This document is intended for the SonoTTTM Clamp-On Transducer and describes

the use of the SonoTTTM Clamp-On Transducer in combination with the

SonoTTTM Ultrasonic FlowComputer.

• The user (= the person who connects the SonoTTTM Clamp-On Transducer to

the tubing circuit and measurement system) is responsible for any risk if the

SonoTTTM Clamp-On Transducer is not connected correctly.

• Inspect your SonoTTTM Clamp-On Transducer for completeness and damage when unpacking

it for the rst time.

• The customer must ensure that the persons involved in the integration and use of the

SonoTTTM Clamp-On Transducer and the system it is part of are adequately qualied. In

addition, the information in these operating instructions must be followed.

• Do not drop the SonoTTTM 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

SonoTTTM 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 SonoTTTM 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 SonoTTTM Clamp-On Transducer (in combination with a SonoTTTM Ultrasonic FlowComputer) is indicated for

the bi-directional volumetric measurement of the liquid owing 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

SonoTTTM Ultrasonic FlowComputer such as:

• cardio-pulmonary bypass, hemodialysis, hemoltration, plasmapheresis

• ECMO (ExtraCorporeal Membrane Oxygenation) applications

• perfusion, infusion, transfusion

• several shunt-applications

Intended Users of the SonoTTTM Clamp-On Transducer

For reasons of patient safety, the device may only be used by qualied and trained medical professionals.

SonoTTTM Clamp-On Transducer

Page 8 D162-700 SonoTTTM Clamp-On Transducer - Operating Instructions V3.0 Copyright em-tec GmbH

Intended Patients of the SonoTTTM 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 SonoTTTM Clamp-On Transducer

The SonoTTTM Clamp-On Transducer is designed for the continuous operation in intensive care units, operating

rooms and similar medical environments.

ClinicalBenets

Additional information for the attenting physician on the ow 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 SonoTTTM Clamp-On Transducer and the SonoTTTM 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 veried 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 SonoTTTM 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).

SonoTTTM Clamp-On Transducer

5.4 Liabilities and Responsibilities

The user is responsible to use, check and maintain the SonoTTTM Clamp-On Transducer according to these

operating instructions.

em-tec GmbH is neither liable nor responsible for any consequences arising from the use of the

SonoTTTM Clamp-On Transducer that does not comply with the operating instructions or specications in this

document.

5.5 Notice Concerning Compulsory Registration

Any major incidents in any ways connected to the product must be immediately reported to the manufacturer

and the appropriate authority of the member state in which the user and/or patient reside in.

5.6 Safety Instructions

If the SonoTTTM Clamp-On Transducer is part of a medical application, the user has to observe the following

instructions:

• The measured values of the SonoTTTM Clamp-On Transducer, supplied through the corresponding evaluation

device (i.e. the SonoTTTM Ultrasonic FlowComputer) only display the current ow rate (e.g. of an oxygenator

or blood pump).

• These values are neither to be used for the evaluation of a patient’s status nor for the basis of medical

actions without the conrmation of another approved medical measurement procedure.

• Should the unit be used to control the liquid volume ow, the user has to analyze the risk of the application

and, if necessary, take additional actions independent from the system to minimize this risk.

5.7 Electromagnetic Compatibility

Medical electronic devices are subjected to special precautions in terms of the electromagnetic compatibility

(EMC). Because of this, the SonoTTTM Clamp-On Transducer and SonoTTTM Ultrasonic FlowComputer have to be

installed and operated according to the following EMC information.

The SonoTTTM Ultrasonic FlowComputer and the SonoTTTM Clamp-On Transducer fulll the requirements of

the

IEC 60601-1-2 4

ed.

. Compliance with these requirements can only be guaranteed if the device is used

according to the operating instructions.

This device fullls the requirements of Class A according to CISPR 11 and should not be operated in home

care, industrial areas, or environments with strong electromagnetic elds or disturbances.

Portable RF communications equipment (including peripherals such as antenna cables and external

antennas) should be used no closer than 30 cm (12 inches) to any part of the SonoTTTM Clamp-On Transducer

or SonoTTTM Ultrasonic FlowComputer including the cables. Otherwise, degradation of the measurement

performance and stability of this equipment could result.

If an electric cautery comes in contact with the device or the SonoTTTM Ultrasonic FlowComputer, it might

cause a dysfunction which can lead to incorrect measurement values or other problems. This includes use

of HF surgery at the patient or crossing of lines. Increased emission or decreased electromagnetic noise

immunity can affect the measurements.

SonoTTTM Clamp-On Transducer

Page 10 D162-700 SonoTTTM Clamp-On Transducer - Operating Instructions V3.0 Copyright em-tec GmbH

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