Aquafilter
E9_Next_Ing_rev03 – 10/10/2018
6
E9 NEXT
CHAPTER 2
2.1
REFERENCE STANDARDS
Steam sterilizer E9 NEXT.
The saturated steam sterilizer complies with the essential requirements of Council Directives:
Medical devices 93/42/EEC of 14/06/93 and 2007/47/EC, class IIb -
0051
It also complies with the national standards in their harmonized versions:
EN 13060
EN 61010-2-040
EN 61326
Boiler
The boiler complies with the following standards:
EN 13445
It also complies with the essential requirements of Council Directives:
Pressure vessels 2014/68/UE del 15/05/2014 - Category II–D1 -
0497
2.2
STAFF REQUIREMENTS
The staff authorized to use and service the equipment must possess the following requirements:
- sufficient general culture to understand the contents of this manual;
- knowledge of the unit and its place of installation;
- knowledge of health, accident prevention, and technical regulations.
The main figures who operate and service the unit are shown below.
The
OPERATOR
is the person who physically uses the unit for the purpose for which it has been designed.
The
RESPONSIBLE AUTHORITY
is the person or group responsible for the use and routine maintenance of
the unit and for operator training.
The responsible authority is legally responsible for the installation, operation and use of the unit.
2.3
USING AND STORING THE MANUAL
This manual refers to the following series and models of appliance:
Series
Model
E9 NEXT
E9 NEXT 18L
E9 NEXT 24L
This manual is an integral part of the product and must be kept near the unit for quick and easy consultation.
The purpose of this manual is to give instructions on:
- correct installation;
- the safe and efficient use of the unit;
- routine maintenance.
The unit must be used according to the procedures contained in the manual and only for the purpose for
which it was designed. The occupational health and safety directives in force in the Country of destination of
the unit must be known and applied in the place of use.
The manual must be kept in a safe place, easily accessible to all personnel; it must also be handled with
care. It is forbidden to remove, rewrite, or modify the contents of this manual in any way.
The drawings and any other documents delivered with the unit may not be divulged to third parties in that
Euronda S.p.A. is the sole owner and reserves all rights to them.
Reproduction of the text and illustrations, in full or in part, is strictly forbidden.