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Renfert
1.4
CE mark
This unit fulfils CE marking requirements in line with EU (EC/EEC) directives. Details are stated in the
EU declaration of conformity that can be obtained from the manufacturer.
Technical changes to the unit must be approved by the manufacturer. The unit is no longer CE com-
pliant if opened by an unauthorised person.
2
Proper use
The unit is used exclusively to treat objects and materials submerged in cleaning fluid with ultrasound.
The cleaning effect is produced by the purely physical action of the ultrasound generated by the unit.
The cleaning power can be boosted by adding suitable cleaning agents [} 9] and by increasing the
temperature and duration of the bath. The unit is also authorised for use in typical laboratory applica-
tions, such as the preparation of samples by degassing, emulsifying or dispersing fluids and solutions.
The unit is classified as a class I medical device in line with the EU Medical Device Regulation and is
designed exclusively for use in commercial environments. Only original accessories manufactured for
the unit are permitted to be used.
The following objects are considered to be appropriate cleaning goods as long as the object in ques-
tion is approved for cleaning in an ultrasonic bath. The list is not exhaustive:
• Medical and surgical microinstruments/instruments.
• Other medical devices.
• Dental instruments and dental laboratory materials.
• Podiatry instruments.
• Instruments from the tattooing and piercing sector.
• Laboratory tools such as flasks, filters and plastic objects.
• Spectacles and objects used in timepiece and jewellery production.
• Industrial products and industrial objects.
Using the unit in any other way is considered improper use.
The operator is responsible for assessing the cleaning results.
2.1
Cleaning medical devices
The unit is used to clean and pre-clean medical devices. The following conditions must be fulfilled:
• The medical device is approved for ultrasonic cleaning and reprocessing (see information from the
medical device manufacturer in line with EN ISO 17664).
• The medical device is only reused if downstream cleaning and preparation procedures ensure that
it is properly cleaned, disinfected and sterilised.
• In cases of doubt, information on using and cleaning the device that is stipulated in the associated
manual must be given precedence.
Pre-cleaning medical products does not replace subsequent cleaning, disinfection
IMPORTANT
or sterilisation using automated standard processes, e.g. washer-disinfectors or
autoclaves.
2.2
Misuse
Misuse refers to any use of the unit that deviates from proper use. Misuse has the following con-
sequences:
• Any misuse at own risk.
Easyclean MD
2 Proper use
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