14.4 Appendix D: Safety information
The Urilyzer 100 was designed and manufactured to comply with the following
international regulations, and left the factory in a safe condition. To keep the
analyzer in a safe condition, you must observe all instructions and warnings
included in this manual.
The instrument complies with the protection requirements of EN 61010 1:2001,
EN 61010 2 101:2002 and EN 61326 1:2006, EN 61326 2 6:2006.
The instrument is certified as meeting the EMC requirements and safety specifi-
cations of the In Vitro Diagnostic Directive (98/79/EC). Per IEC 61326-2-6 it is the
user’s responsibility to ensure that a compatible electromagnetic environment
for this instrument is provided and maintained in order that the device will per-
form as intended. Do not use this device in close proximity to sources of strong
electromagnetic radiation (e.g. unshielded intentional RF sources), as these may
interfere with the proper operation. The electromagnetic environment should be
evaluated prior to operation of device.
This equipment has been designed and tested to CISPR 11 Class A. In a domes-
tic environment it may cause radio interference, in which case, you may need to
take measures to mitigate the interference.
The analyzer must be operated only with the prescribed power supply unit (Class
II protection).
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, too. 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 subsequently attempt to use it. Make sure
that only trained members of staff operate the Urilyzer 100 analyzer.
Any personal computer to which the analyzer is connected must meet the EN
60950, UL 60950/CSA C22.2 No. 60950 requirements for data processing equip-
ment.
Only connect the intended external devices with safety low voltages to the
corresponding interfaces (serial, PS2, USB, Ethernet) to avoid the risk of electrical
shock or the risk of damaging the devices or the analyzer.
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 coordina-
tion with your local authority, if appropriate.
Please note that the instrument may potentially be infectious. Equipment must
be decontaminated before repair, maintenance, or removal from the laboratory.
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.
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