Operating Manual WD 425E
Rev. 1.1, LS Page 4 of 34 78563_E rev 1.1.doc
!IMPORTANT NOTICE!
Be sure to carefully read and understand this manual prior to commissioning the automat.
Limitations of Application
The manufacturer does not assume any responsibility for damages resulting from improper application of
the machine, such as operating errors, unintended application or operation by untrained personnel as well
as failure to follow instructions found in this manual. Modifications of the automat, especially technical
modifications by unauthorized personnel – without written consent by the manufacturer - will result in total
loss of all warranty claims. Product liability will be annulled.
The cleaning automat is designed exclusively for the range of applications listed in the user manual, i.e.
reusable medical products.
Operation of this machine is designed only for indoor operation such as laboratories and hospitals. Appli-
cation for textile materials may result in damage to the machine. The operation must be handled by prop-
erly instructed and trained personnel.
!CAUTION!
Cleaning and disinfection performance
A cleaning assignment is assured only if
• a validation of the program parameters such as dosing and appropriate assignment of media has
been completed by qualified personnel,
• the wash arms are permitted to freely rotate,
• wash good racks have been properly loaded,
• the position of loading rack docking devices match those of the machine,
• original load racks of the respective machine are used (no foreign products),
• coarse sieves and wash arms are all in place and are regularly cleaned,
• scheduled maintenance operations are correctly carried out by technical personnel.
Special note: clean filters and dosing pumps must be regularly serviced and checked.
Validation
The top goal of process validation in the realm of the statute for medicinal products is to assure a high de-
gree of safety in processing medicinal products, thus protecting the health of the patient and the machine
operator. The initial validation always consists of these elements: acceptance procedures, functions and
performance assessment.
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