Bowa LOTUS Serie Instrucciones De Uso página 12

(134 – 137 ºC) for a minimum of 3 and a maximum of 4 minutes with a 5 minute
drying cycle (if national standards dictate autoclaving up to 18 minutes, this is
possible but not preferable.)
STORAGE
• Store sterile packaged instruments in a manner that provides protection from
dust, moisture, insects, vermin, and extremes in temperature and humidity.
RETURN
• Before returning the LOTUS system or any individual components to the manu-
facturer, please ensure that washing and sterilization have been carried out. All
equipment must undergo a valid cycle. A certification of decontamination must
accompany the system or any individual components on their return.
The instructions provided above have been validated by the manufacturer as being
CAPABLE of preparing a medical device for re-use. It remains the responsibility
of the processor to ensure that the processing is performed using equipment,
materials and personnel in the processing facility to achieve the desired result. This
requires validation and routine monitoring of the process. Likewise, any deviation
by the processor from the instructions provided should be properly evaluated for
effectiveness and potential adverse consequences.
7 OPERATION, STORAGE AND TRANSPORT
Operating conditions: Temperature: +10 to +50 °C; Relative humidity: 0 – 100 %,
non-condensing; Air pressure: 810 – 1060 hPa.
Store the Transducers in a clean, dry place in accordance with the storage condi-
tions. Storage conditions: Temperature: -20 to +50 °C; Relative humidity: 0 – 100 %,
non-condensing; Air pressure: 500 – 1060 hPa.
Protect the Transducers from exposure to direct sunlight during storage. It is recom-
mended to keep the Transducer in the original packaging until use.
8 DISPOSAL
The medical device or its components, packaging material and accessories must be
disposed of in accordance with any applicable country-specific regulations and laws.
SYMBOL DESIGNATION
A device marked with this symbol must be put into the separate was-
te collection for electrical and electronic devices. Disposal is carried
out free of charge by the manufacturer within the European Union.
9 SYMBOLS GLOSSARY
Catalogue Number
Quantity
Serial Number
Consult instructions for use
Manufactured By
12
Date of manufacture
Keep dry
Keep out of direct sunlight
Caution: Federal (USA) law
restricts this device to sale
by or on the order of a
physician