Application; In General; Ec - Declaration Of Conformity; Explanation Of Symbols And Accompanying Word(S) - Kulzer PALA Palajet Instrucciones De Uso

1

Application

1.1

In general

Palajet is a registered trademark of Kulzer GmbH, 63450 Hanau (Germany).
®
These operating instructions apply to:
Order no.
66020450
GB
1.2 EC – Declaration of Conformity
We, Kulzer GmbH, Leipziger Straße 2, 63450 Hanau (Germany),
- 2 -
hereby declare that the design, structure and version introduced
to the market of the unit described below correspond to the relevant
safety and health requirements of the EU Directive.
This declaration shall become invalid in the event of an alteration
made to the unit without our prior authorisation.
1.3

Explanation of symbols and accompanying word(s)

Symbols
Type Features
Palajet – Injection unit
Accompanying word(s)
WARNING
NOTE
Date
2017-07 / 66035914/11
Explanation
Identifies conditions or practises that present risk of injury to the patient
and or user.
Instructions on using the unit optimally.
Read the Operating instruction – method and instructions for use.
Device manufactured in conformity with European directives and guidelines
and is labed with CE mark.
Valid from Serial no.
2017-07-1000