4
1
Installation Declaration
1.1
PMZ10ES Installation Declaration
within the meaning of the Machinery Directive 2006/42/EC, Annex II, 1.B for incomplete machines
Manufacturer:
Phoenix Mecano Komponenten AG
Hofwisenstrasse 6
CH-8260 Stein am Rhein
confirms that the product named therein
Product designation:
PMZ10
Type designation:
PMZ10
Trade name:
PMZ10
Function:
Electromotive extension and retraction of the pushrod for creation of
linear motion
meets the requirements for an
incomplete machine
according to the Machinery Directive
2006/42/EC.
The following essential requirements of the Machinery Directive 2006/42/EC according to Annex I have been applied and fulfilled:
1.1.5.; 1.3.2.; 1.3.3.; 1.3.4.; 1.3.7.; 1.5.1.; 4.1.2.1.; 4.1.2.3.
It is also declared herewith that the special technical documentation according to Annex VII Part B has been compiled.
It is expressly stated that the
incomplete machine
complies with all applicable provisions of the following EC guidelines:
2011/65/EU
Directive 2011/65/EU of the European Parliament and the Council dd. 8 June 2011 on the restriction of the
use of certain hazardous substances in electrical and electronic equipment
IEC 60601-1-2:2014
Medical Electrical Equipment
– Part 1-2: General requirements for basic safety and
Essential performance
– Collateral standard: Electromagnetic disturbances – Requirements and
test (IEC 60601-1-2:2014); German version EN 60601-1-2:2015
Phoenix Mecano Komponenten AG undertakes to submit technical documentation for the incomplete machine upon substantiated request
of the national competent bodies in electronic format.
A person established within the Community and authorised to draw up the relevant technical documentation:
Timo Fluck
Phoenix Mecano Komponenten AG
Hofwisenstrasse 6
CH-8260 Stein am Rhein
Setting into operation is forbidden until it is established that the machine, into which this incomplete machine
is installed, complies with the provisions of the EC Directive 2006/42/EC.
It must comply with the CE guidelines prior to marketing, including with regard to documentation.
Stein am Rhein / 18.06.2019
Timo Fluck
_______________________
__________________
Technical supervision
Mechanical components
(place/date)
(signature)
(identification of the signatory)
