ECGC-70-002, Rev. 8, February 05, 2019
4
Copyright Declaration
Copyright
©
2012 Cardiac Designs, Inc.
All rights reserved.
iPhone, iPad, iPod, iOS and the Apple logo are either registered trademarks or
trademarks of Apple Corporation in the United States and/or other countries.
Cardiac Designs, Inc., Cardiac Designs logo, and ECG Check and ECG Web Center
are
trademarks or registered trademarks of Cardiac Designs, Inc.
All other brand names and product names used in this document are trade names,
service marks, trademarks, or registered trademarks of their respective owners.
The information and screens provided in this manual are subject to change without
notice.
Cardiac Designs, Inc. SHALL NOT BE LIABLE FOR TECHNICAL OR EDITORIAL ERRORS OR
OMISSIONS CONTAINED HEREIN; NOR FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES
RESULTING FROM THE FURNISHING, PERFORMANCE, OR USE OF THIS MATERIAL.
Authorized Representatives:
USA
Cardiac Designs, Inc.
695 Minnesota Street
San Francisco, CA 94107
Tel: 844-324-2432
EU
Medes, Ltd.
5 Beaumont Gate, Shenley Hill,
Radlett, Hertfordshire, WD7 7AR
England, UK
Declaration of Conformity
Conformance to Standards
–
non-clinical testing demonstrated conformance to
voluntary safety IEC 60601-1, and IEC 60601-1-2-2007 Class B.
Type CF Applied Part. Complies with Part 15C of FCC Rules for Class B Digital Devices.
Cardiac Design, Inc.
’
s Quality System conforms to 21 CFR 820 and ISO 13485:2016
