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1566g GB/2019-02
1
electronic GmbH & Co. KG • Heinrichstraße 3-4 • 12207 Berlin • Deutschland • [email protected]
1.2
Purpose
General application
SONOREX ultrasonic baths are intended for the sonication of aqueous
fl
uids. They work on the
basis of low-frequency ultrasound and can be used in versatile ways. Their main application is
gentle and intensive cleaning of objects of diverse shapes, types and sizes. Alternatively, chemical
processes can be favourably supported and accelerated in an ultrasonic bath, e.g. when preparing
or treating samples.
Sonication is always carried out in connection with a suitable preparation that is added to the bath
liquid. In order to use the device as intended, a basket or another inset beaker, into which objects
are placed during sonication, is also required. Only in this manner is the optimum diffusion of the
ultrasound guaranteed.
The ultrasonic bath is operated from the front. The operation is usually carried out on a table.
Ultrasound treatment of medical instruments
SONOREX ultrasonic baths are used to treat medical instruments:
a) during manual treatment
b) before machine treatment
c) after machine treatment
In this connection, they are to be used together with suitable, non-
fi
xative disinfection and/or
detergent preparations, in order to support or expedite their effect. Pursuant to section 2, para. 1
and section 3, paras. 1, 9 and 10 of the Medical Devices Act (MPG), the ultrasonic bath thus
becomes a medical device as an accessory to the preparations, and is to be treated as one.
This includes pre- and post-processing steps for the medical instruments, e.g. the observance
of KRINKO
/1
recommendations in "Hygiene requirements for the treatment of medical products"
and other applicable domestic regulations. Additional information in this respect can be found in
chapter 4.3.
1.3
CE conformity
SONOREX ultrasonic baths are declared as medical products
/2
and satisfy the CE marking criteria
for the European
- "Medical Device" directive
- "Low-voltage directive"
- "Electromagnetic compatibility" directive
- WEEE - Directive
in their currently valid versions.
A declaration of conformity can be requested from the manufacturer by providing the serial
number.
/1 In Germany: Empfehlung der Kommission für Krankenhaushygiene und Infektionsprävention (KRINKO) beim Robert Koch-Institut (RKI)
und des Bundesinstitutes für Arzneimittel und Medizinprodukte (BfArM); Bundesgesundheitsblatt - 2012•55:1244-1310.
/2 Exception: see "Technical data" overview
