Alpinion Medical Systems X-CUBE 70 User manual

DIAGNOSTIC ULTRASOUND SYSTEM
X-CUBE 70
Quick Guide
Rev. 0 (ENG)
D/N: 70003656

i-2 X-CUBE 70 Quick Guide
Proprietary Informaon and Soware License
Proprietary Informaon and Soware License
This document and the informaon contained in it is proprietary and condenal informaon
of ALPINION MEDICAL SYSTEMS (hereinaer called Alpinion) and may not be reproduced,
copied in whole or in part, adapted, modied, disclosed to others, or disseminated without the
prior wrien consent of Alpinion. This document is intended to be used either by customers,
and is licensed to them as part of their Alpinion equipment purchase. Use of this document by
unauthorized persons is strictly prohibited.
Alpinion provides this document without warranty of any kind, implied or expressed, including,
but not limited to, the implied warranes of merchantability and tness for a parcular
purpose.
Alpinion has taken care to ensure the accuracy of this document. However, Alpinion assumes
no liability for errors or omissions and reserves the right to make changes without further
noce to any products herein to improve reliability, funcon, or design. Alpinion may make
improvements or changes in the products or programs described in this document at any me.
Unauthorized copying of this document, in addion to infringing copyright, might reduce the
ability of Alpinion to provide accurate and current informaon to users.

i-3
Original Documentaon
Original Documentaon
The original document was wrien in English and published in PDF File.
The English version of the user documentaon is intended for the countries of the European
Union, North or South America, Asia as well as other worldwide countries where the products
are sales and used. In addion, the English version of the user documentaon is designed so
that the majority of people who are familiar with English can read and correctly understand
the instrucons.
The user documentaon is translated into other languages so that most people who are
familiar with languages other than English can read the instrucons and understand them
correctly. The translated user documentaon is intended for users who speak the language of
the country where they sell and use the product.
Please note that the authoritave source of informaon is the English version. If there is any
conict between the translated versions and the English, the laer takes precedence.

i-4 X-CUBE 70 Quick Guide
Precauons For Use
Precauons For Use
Be sure to read this manual and fully understand the operaon of the product and the relevant
safety informaon before using the product.
•Keep this manual near the product and refer to it when using the product.
•The contents and specicaons described in this manual may be changed without noce.
•All important safety informaon in the "4. Safety" should be read and thoroughly
understood before operang the unit.
•Be sure to read and fully understand the safety precauons idened by the following ag
words and icons which precede the precauonary statement.
WARNING
WARNING indicates that a specic hazard is known to exist which through
inappropriate condions or acons may cause severe or fetal personal injury or
substanal property damage.
CAUTION
CAUTION indicates that a potenal hazard may exist which through inappropriate
condions or acons will or can cause minor poersonal injury or property damage
such as loss of paent or system data.
NOTE
NOTE indicates precauons or recommendaons that will help you operate the
product more eecvely.
•This product is intended for use by, or by the order of, and under the supervision of a
licensed physician qualied to direct the use of the device.
•This product is intended for ultrasound diagnosis and cannot be used in your PC
environment. We are not responsible for any problems that occur in such situaons.

i-5
Regulatory Requirements
Classicaons
•Type of protecon against electrical shock: Class I
•Degree of protecon against electrical shock (Paent connecon): Type BF equipment
•Degree of protecon against harmful ingress of water: Ordinary equipment and all of
applied parts (IPX7, IPX8) except ECG meet ingress protecon level according to IEC 60529.
•Degree of safety of applicaon in the presence of a ammable anesthec material with
air or with oxygen or nitrous oxide: Equipment not suitable for use in the presence of a
ammable anesthec mixture with air or with oxygen or nitrous oxide.
•Mode of operaon: Connuous operaon
Electromechanical safety standards met
•MDD 93/42/EEC
•EN ISO 10993-1:2009 (ISO 10993-1:2009)
•EN ISO 10993-10:2013 (ISO 10993-10:2010)
•EN ISO 10993-5:2009 (ISO 10993-5:2009)
•EN ISO 13485:2016 (ISO 13485:2016)
•EN ISO 14155:2011+AC:2011 (ISO 14155:2011)
•EN ISO 14971:2012 (ISO 14971:2007)
•EN ISO 15223-1:2016 (ISO 15223-1:2016)
•EN 1041:2008+A1:2013
•EN 55011:2016+A1:2017 (CISPR 11:2015/AMD1:2016)
•EN 55032:2015 (CISPR 32:2015)
•EN 60601-1:2006+A1:2013 (IEC 60601-1:2005/AMD1:2012)
•EN 60601-1-2:2015 (IEC 60601-1-2:2014)
•EN 60601-1-6:2010+A1:2015 (IEC 60601-1-6:2010/AMD1:2013)
•EN 60601-2-37:2008+A11:2011+A1:2015 (IEC 60601-2-37:2007/AMD1:2015)
•EN 61000-3-2:2014 (IEC 61000-3-2:2018)
•EN 61000-3-3:2013 (IEC 61000-3-3:2013)
•EN 61000-4-11:2004 (IEC 61000-4-11:2004)
•EN 61000-4-2:2009 (IEC 61000-4-2:2008)
•EN 61000-4-3:2006+A1:2008+A2:2010 (IEC 61000-4-3:2006/AMD2:2010)
•EN 61000-4-4:2012 (IEC 61000-4-4:2012)