Bayer HealthCare MEDRAD 800 Module Operation & Installation Manual page 3

English
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MEDRAD Stellant Imaging System
Interface (ISI) 800 Module
Operation and Installation Manual
Operating specifications, options, accessories, and feature availability may
vary by country. Check with local product representative and country-specific
operating instructions.
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The MEDRAD Stellant Imaging System Interface (ISI) 800 Module has an
expected service life* of 7 years from the date of product installation when
operated according to the instructions provided with this device. These 7
years include suggested or mandatory actions of preventative maintenance
and repair activities, as well as required calibration(s) that are needed.
Required reading includes the instructions for use and other materials
provided with the device. This also includes any hardware and software
updates that may be required.
* Expected Service Life: The length of time that an individual unit, lot, or batch
of devices is expected to remain functional after it is placed into use.
Report any serious incident that has occurred in relation to this device to
Bayer (radiology.bayer.com/contact) and to your local European competent
authority (or, where applicable, to the appropriate regulatory authority of the
country in which the incident has occurred).
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A glossary of the symbols used on the MEDRAD Stellant Imaging System
Interface (ISI) 800 Module can be found in Section 1 of this manual.
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