4 Putting the sterilizer into service
Thermo Scientific
18
50112712_082007_GB
INFORMATION
The door locking mechanism is electro-mechanically locked as
delivered! Connect to mains to unlock and terminate transport
program.
INFORMATION
You may use a separate condensate collector if the room
climate is not adversely affected by the excess heat, hot
condensate or spent steam generated during sterilization. Do
not use the "tap water" connection as otherwise the collector
may overflow and cause water damage.
Especially in case of contaminated exhaust air, the water in the
collector as well as the collector itself may be infected with
germs. This factor is to be considered when disposing of the
collector content.
The steam sterilizer is marked with a type plate of the manufacturing company.
This type plate lists all the technical specifications required for classification of the
pressure vessel and steam boiler. A spare-parts store for this instrument is
maintained at the manufacturer's factory. Availability of parts is guaranteed for 10
years.
The VARIOKLAV Type 65 TC steam sterilizer has been marked with the four-digit
CE mark and the number of the Notified Body (TÜV), 0123, pursuant to Section
9 of the German Medical Devices Law. It has undergone conformity assessment
pursuant to the EU Guideline 93/42/EEC (Article 11, Annex II). The Declaration of
Conformity is based on a complete quality assurance system pursuant to DIN EN
ISO 9001 (1994).
The sterilizer has been manufactured according to the requirements of EN DIN 285
(02/97).
The steam sterilizer meets the general requirements of and has undergone testing
pursuant to DIN EN 60601 and the threshold limits for electromagnetic
compatibility (EMC) contained therein. This German standard is also a VDE
standard (VDE 0750).
VARIOKLAV Type 65 TC sterilizers are not machines
4)
pursuant to the EU
Machinery Directive 89/392/EEC (steam boilers, tanks and pressure vessels are
explicitly excluded).
The pressure equipment and steam boiler (double wall) comply with the new
Pressure Equipment Directive 97/23/EC.
The following operating documents are supplied with the delivery (as invoiced):
-
Declaration of Conformity for the sterilizer pursuant to the European Guideline
concerning Medical Devices 93/42/EEC
4)
Excerpt from the Council Directive ”Machinery” 89/392/EEC:
Article 1
(2) For the purposes of this directive, "machinery" means an assembly of linked parts or components, at
least one of which moves, with the appropriate actuators, control and power circuits, etc., joined
together for a specific application, in particular for the processing, treatment, moving or packaging of a
material. The term "machinery" also covers an assembly of machines which, in order to achieve the
same end, are arranged and controlled so that they function as an integral whole.
(3) The following are excluded from the scope of this Directive:
steam boilers, tanks, and pressure vessels.
