Medirol EXTERO P113, User Manual

Page: 5 / 20

5
ES Conformity Declaration
According § 13 sec. 2 law no.22/1997 about technical requirements for products and according
government regulation no. 336/2004 by which is stated technical requirements at medical means.
Producer:
MEDIROL s.r.o., Na Strži 126/4, 140 00 Praha 4, Czech Republic, VAT no.: CZ64506592
Manufacturing plant:
MEDIROL s.r.o., Dolní Dubňany 58, 671 73 Tulešice, Czech Republic
Product´s name and type:
EXTERO P113
Description:
Medical mean for transport of recumbent patient into and outside of ambulance car.
Registered in class:
Non-invasive I
Statement
Meet basic requirements, in common use in accordance with user manual is safe, effective, and
appropriate for providing health care. Producer accepted precautions by which ensure conformity of
all medical means with the technical documentation and the basic requirements of the Government,
which apply to it.
To proof the conformity was used following documentation:
•
Technological regulation P113
•
Government regulation no. 336/2004
•
ČSN EN 1865, 1789
•
Protocol no. 120460-09-TAC about test according regulation ČSN EN 1789 issued by TÜV SÜD
Auto CZ s.r.o. 12.6.2009 in Prague
In Prague, 6. 9. 2011
Ing. Diana Rysková
Managing Director and CEO