STILLE imagiQ2, User Manual, Page: 2 / 28

Copyright © 2015 STILLE AB. All rights reserved.
The contents of this manual are the property of STILLE AB. Any reproduction in whole or in part is strictly prohi-
bited. Trade marks: True Free Float™, ISO ROLL™ and imagiQ2™ are trademarks owned by Stille AB.
At the time of printing, this manual correctly described the device and its functions. However, as modifications
may have been carried out since the production of this manual, the system package may contain one or more
amendments to the manual. This manual including any such amendments must be thoroughly read, before using
the device.
The English version of the User Manual and Service Manual is the original instructions. Manuals in other langu-
ages are a translation of the original instructions.
The following imagiQ2™ models are covered by this manual: 530-1700 imagiQ2 EU 230V, 530-1701 imagiQ2
GB 230V, 530-1702 imagiQ2 JP100V, 530-1703 imagiQ2 US 120V.
The imagiQ2 operating table is CE marked in conformity with the essential requirements, according to annex I,
and classified, according to annex IX, as Class I (rule 12) of the Medical Device Directive 93/42/EEC.
We declare the compliance of the medical device concerned with the Swedish Medical Devices Act (1993:584)
and the regulation LVFS 2003:11 of the Medical Products Agency. Hereby, the medical device complies with the
requirements of the Medical Device Directive 93/42/EEC, the amending Directive 2007/47/EC and the appli-
cable harmonized standards as well as the RoHS directive 2011/65/EU and the WEEE directive 2012/19/EU.
The device does also comply with the International standards, IEC 60601-1, IEC/EN 60601-2-46, UL 60601-
1. CAN/CSA C22.2 No 601.1-M90. Any modification to the device, not authorized by us, will invalidate this
declaration.
The original signed CE declaration of conformity is a separate document can be obtained upon request.
Classifications
CE Medicla device classification: Class 1
GMDN code: 36606
FDA Regulation Status: Class 1 Exempt 878.4960 (GDC)
FDA List No.: E130044
Warranty terms for imagiQ2™ vascular imaging table:
To be able to benefit the full warranty terms of the Stille imagiQ2, the installation report that comes enclosed
( http://www.stille.se/iq2registration/ ) with the documetation must be filled in at installation and returned to
QA@STILLE.SE
Information regarding Stille Warranty Provisions can be found on Stilles website, http://www.stille.se.
If you do not find the installation report please do contact QA@STILLE.SE for a copy.
It is recommended that all repairs and modifications are carry out by authorized personnel.
Manufacturer:
Stille AB
Ekbacken 11
SE-644 30, Torshälla
Sweden