Product Manual

Operator’s Manual V03

10.2 Safety Notices

This analyzer was designed and manufactured to comply with following international regulations, “Safety requirements for

electrical equipment for measurement, control and laboratory use” and left the factory in a safe condition. In order to keep

the instrument in a perfect and safe condition, it is up to the user to observe all instructions and warnings included in this

manual.

This product fulfils the requirements of Directive 98/79/EC on in vitro diagnostic

medical devices.

C US

Issued by Underwriters Laboratories Inc. (UL) for the USA and Canada.

The instrument must only be operated with the prescribed power supply unit (Class II protection).

The instrument is classified as Category II for overvoltage and Degree 2 for pollution according to IEC 664.

Opening covers or removing parts of the instrument, except where this can be achieved manually without the use of any

tools, may expose voltage-carrying components. Connectors can be live. Never try to maintain or repair an open instrument

which is carrying voltage.

If you suspect that the instrument can no longer be operated safely, turn it off and take steps to ensure that no one will

subse quently attempt to use it. Make sure that only trained members of staff operate the Urisys 1100

Urine Analyzer.

Any personal computer to which the analyzer is connected must meet the EN 60950, UL 60950 and CSA C22.2 No. 60950

requirements for data processing equipment.

If the instrument is to be taken out of operation entirely and disposed of, it must be disposed of in conformity with the

relevant legal regulations and in co-ordination with your local authority, if appropriate.

Please note that the instrument may potentially be infectious. It should therefore be decontaminated before disposal, e.g.

by cleaning the housing and the test strip tray with 70 % alcohol.

ATTENTION: The data and information contained in this manual are accurate at the time of printing.

Any substantial changes will be incorporated in the next edition. In case of conflict between this manual and information

given in package inserts, the package inserts shall take precedence.

10.3 Warranty

Roche Diagnostics warrants the Urisys 1100

Urine Analyzer against defects in material and workmanship (except for

consumable items) for a period of one year. Roche Diagnostics will replace the instrument provided written notice of

defect within 30 days of occurence, all parts which prove to be defective and subject to such warranty.

This warranty does not apply to an instrument not used according to instructions or damaged by accident, alteration,

misuse, tampering, and/or abuse.

THE FOREGOING WARRANTY SHALL BE IN LIEU OF ALL OTHER WARRANTIES, WHETHER EXPRESSED, IMPLIED OR

STATUTORY, INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A

PARTICULAR PURPOSE.

ROCHE DIAGNOSTICS SHALL HAVE NO FURTHER OBLIGATION OR LIABILITY WITH RESPECT TO THE INSTRUMENT

OR PARTS THEREOF OR ITS SALE, OPERATION, OR USE, AND ROCHE DIAGNOSTICS NEITHER ASSUMES NOR

AUTHORIZES THE ASSUMPTION OF ANY OBLIGATION OR LIABILITY IN CONNECTION WITH SAID INSTRUMENTS OR

PARTS THEREOF.

CUSTOMERS’ SOLE AND EXCLUSIVE REMEDY IN CONTRACT, TORT, OR UNDER ANY OTHER THEORY AGAINST

ROCHE DIAGNOSTICS, RESPECTING THE INSTRUMENT, PARTS THEREOF AND THE USE OF SAME SHALL BE THE

REPLACEMENT OR REPAIR OF THE INSTRUMENT AND ITS PARTS AS DESCRIBED ABOVE. IN NO CASE SHALL

ROCHE DIAGNOSTICS BE LIABLE FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES.