Cardiocity Limited – RhythmPad
GP
– User Guide- Page 10
RhythmPadGP Manual.doc 20/05/16
Ensure regular inspections of the USB cable and RhythmPad
GP
device housing
checking for insulation and or cable damage.
No modifications of this equipment is allowed
1.11 Device Description
The RhythmPad
GP
is an A4 sized polycarbonate hand placement ECG monitoring
platform. The product contains active electrode sensors which provides a new way for
acquiring leadI ECG data from a subject's hands. The device is designed to be used
with third party software which can receive the USB formatted data from the
RhythmPad
GP
and provide analysis of the subjects cardiac rhythm, and dependent
upon the software used in conjunction with the RhythmPad
GP
, can diagnose certain
arrhythmias that may be identified and established through a leadI reading.
The full diagnostics ability of the RhythmPad
GP
when used in conjunction with the
third part analysis software is restricted to the diagnostics ability of the third party
algorithm. No diagnostics capabilities are provided by the RhythmPad
GP
alone. The
RhythmPad
GP
can be expanded from a one lead to a six lead ECG acquisition tool,
when used with the 3rd electrode accessory. This six lead data can be sent to the
same third party algorithms for analysis thus providing a higher fidelity screening
system.
The RhythmPad
GP
is a medical device that is:
•
categorized as a Class IIa device
•
Class 2 Electric Shock Protection
•
externally powered
•
a Type BF Applied Part
•
a device with an IP rating of type IPX0
•
not suitable for use in an Oxygen rich environment
•
designed for Continuous Use
•
a self calibrating active electrode device
1.12 Purpose
The RhythmPad
GP
is a hand placement leadI ECG sensing system that outputs a USB
stream of ECG formatted data such that third party analysis algorithms and other
software products may receive and apply analysis to.
The RhythmPad
GP
v1.0 is only to be used by a trained operator who
comply with instructions for installation, operation, storage and cleaning
1.13 RhythmPad Data
The RhythmPad
GP
emits a USB data stream in a serial data format, which can be
deciphered using LibUSB, an open source USB library.
1.14 Monitoring the Data
This User Manual details Cardiocity’s RhythmPad suite of ECG analysis software.
1.15 Environmental Notice
The RhythmPad
GP
and accessories are
MEDICAL ELECTRICAL EQUIPMENT
. Medical
Electrical Equipment needs special precautions regarding EMC and needs to be
installed and put into service according to the EMC information provided below. It
should be observed that portable and mobile RF Communications equipment can
affect MEDICAL EQUIPMENT.