Roche cobas Urisys 1100 User Manual

Roche Diagnostics
Urisys 1100® · ≥5.7 · Operator's Manual · 9.0
8 1. Introduction
Combur10Test
®
UX test strips are marketed in Canada as
Chemstrip 10 A test strips.
Approvals
The Urisys 1100
®
system meets the requirements laid
down in:
Regulation (EU) 2017/746 of the European Parliament and
of the Council of 5 April 2017 on in vitro diagnostic
medical devices and repealing Directive 98/79/EC and
Commission Decision 2010/227/EU.
Compliance with the applicable regulation and
directive(s) is provided by means of the Declaration of
Conformity.
!
Incident reporting
r Inform your Roche representative and your local
competent authority about any serious incidents
which may occur when using this product.
Using the Urisys 1100
®
system eliminates factors known
to affect visual evaluation of urine test strips, such as:
• Variable lighting conditions at the workplace
• People’s individual skill at matching colors and their
limits of concentration
• Different reaction times for the test strips
• Clerical errors
• Strong color of the urine sample
Restriction of hazardous substances
The Urisys 1100
®
system (serial# 09652551
and higher) meets the requirements laid
down in: Directive 2011/65/EU of the
European Parliament and of the Council of 8
June 2011 on the restriction of the use of
certain hazardous substances in electrical
and electronic equipment.
BIOHAZARD:
Treat all samples of human origin as being
potentially infectious. Always observe good
laboratory practice.

Roche cobas Urisys 1100 Specifications

General

Brand	Roche
Model	cobas Urisys 1100
Category	Measuring Instruments
Language	English