Warranty; Administration Of Data - Cardiocity RhythmPadGP User Manual

static discharge etc. - Transportation damage due to improper packaging of returns -
Wear due to operation and usual wear. Cardiocity Limited is neither liable for
consequential losses caused by defects, as far as they were not intentional or
involved gross negligence, nor for minor physical injury to life or limb resulting from
negligence. If the warranty claim is rejected, Cardiocity Limited will assume no costs
for the transport between the customer and the manufacturer. The statutory
warranty rights are unaffected by this.

1.30 Administration of Data

The RhythmPad
intended by the manufacturer to be used, in combination, for human beings for the
specific purpose(s) of monitoring, and providing information for medical purposes by
means of collecting data derived from the human body. The data is sent via USB to a
third party computing device where it may be used by independent software
applications to provide a means of screening human beings for cardiac performance.
Any organisations receiving USB data from a RhythmPad
forward or manage the data, in either electronic or paper form, in accordance with
their national regulations regarding Electronic Patient Data and the Data Protection
Act.
1.31 Certificate of Conformity
PRODUCT IDENTIFICATION
Product Name: RhythmPad
MANUFACTURER
Cardiocity Limited, Lab 138, 9 St John's St, Colchester CO2 7NN, Essex, England.UK
Representative: Dr Chris Crockford
REGISTRATION INFORMATION
Notified Body: SGS United Kingdom Limited, 202B Worle Parkway, Weston-super-
Mare, BS22 6WA, UK
Notified Body Number: CE 0120
CE Certificate Number: GB13/90277
Date CE Marking First Applied: 1/1/14.
CONFORMITY ASSESSMENT
Device Classification: Class IIA Route to Compliance Annex II excluding section 4 Of
MDD, Rule 10 - 93/42/EEC Council Directive
Standards Applied: EN ISO 14971, EN ISO13485, EN 60601-1, IEEE 11073:10406,
EN 60601-1-2
Cardiocity Limited declares that the above mentioned products meet the provision of
the Council Directive 93/42/EEC for Medical Devices.
All supporting documentation is retained at the premises of the manufacturer.
COMPANY REPRESENTATIVE
Dr Chris Crockford
Director 10/04/14
RhythmPadGP Manual.doc 20/05/16
GP
system is a medical device. This apparatus and it's accessories are
DECLARATION OF CONFORMITY
GP
Model Number: RP-GPv1.0
Cardiocity Limited – RhythmPad
GP
GP
– User Guide- Page 16
are required to store,