INTRODUCTION & OPERATOR WARNINGS
INTRODUCTION
The AS300 is a Storage Cabinet for Thermolabile Endoscopes.
The AS300 is a system used to store the thermolabile flexible endoscopes, enabling them to be maintained in
aseptic conditions for several days following the last phase of the disinfection protocol applicable to this type
of equipment.
The AS300 storage unit is designed and manufactured in accordance with the European and national Directives
and standards in force; in particular in accordance with the essential safety requirements stipulated by the
provisions of Directive 2006/42/EC (Directive on machines), Directive 2014/35/EU (Directive on low voltages),
Directive 2014/30/EU (Directive on electromagnetic compatibility), Directive 93/42/EC and its amendments
relating to medical devices. The AS300 aseptic storage cabinet conforms to all the applicable requirements of
the European standard EN16442.
Endoscopes must not be stored in the AS300 unit for longer than 7 days.
The list of endoscopes suitable for storage in the AS300 unit is provided by the manufacturer in appendix A to
this user manual. Any endoscope not included on this list must first be validated by the manufacturer of the
cabinet.
The device has been designed for professional use only. It must only be used by authorized and trained
persons.
GOOD PRACTICES
Special attention must be given to the measures implemented to prevent the risk of handborne contamination.
To obtain the required performance level, it is assumed that the endoscopes have been reprocessed to a
satisfactory level of asepsis prior to storage; this is achieved by observation of the hygiene rules and the various
treatment stages for the endoscopes. During set-up of your AS300, you should pay special attention to the
following:
• Appropriate hand hygiene when inserting and removing the endoscopes in and from the AS300: use of
sterile gloves or alcohol gel;
• Immediate transfer of the endoscope following treatment in the reprocessor wherever possible;
• Transfer of the endoscope from the AS300 to the place of use so as not to compromise the asepsis of
the endoscope: using the tray, previously cleaned and disinfected, or a sterile surgical sheet.
• The installation area must be clean and well kept.
OPERATOR AND PATIENT SAFETY
The AS300 must be handled by skilled personnel who have been specially trained to use this device and strictly
for its use.
The user must take care not to trap his/her hands when closing the door of the storage compartment.
Do not remove the fixed parts or panels unless to carry out maintenance work. Such operations must be
performed by qualified personnel, under safety conditions prescribed by the standards in place.
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