Packaging; Transport Conditions; Device Compliance And Intended Use; Rhythmpad Intended Use & Frequently Used Function - Cardiocity RhythmPadGP User Manual

1.3

Packaging

The standard packaging for a RhythmPad
corrugated 150/B/150 box, containing the RhythmPad
the Instructions for Use.
1.4

Transport Conditions

Environmental conditions for transport and storage of the unit as packed in the case
are as shown.
– an ambient temperature range of - 40 °C to + 70 °C;
– a relative humidity range of 10 % to 100 %, including condensation;
– an atmospheric pressure range of 50 kPa to 106 kPa.
1.5

Device Compliance and Intended Use

This product is compliant with COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993
concerning medical devices
2007/47/EC of the European Parliament and of the Council of 5 September 2007
GP
1.6 RhythmPad Intended Use & Frequently Used Function
The RhythmPad
function of the collection and communication of a patient's ECG leadI heart rhythm,
from the patient's hands, via a USB formatted data stream to a receiving device that
may for example, be a personal computer. Upon the receiving device, third party
software may decode the data stream and render an ECG waveform representative of
the patients leadI cardiac output. The RhythmPad
pick up the patients leadI ECG from their hands. Third party software is available that
utilises accredited algorithms that can analyse and decode the ECG waveform and
offer the clinician a judgement on the patient's cardiac output. The RhythmPad
powered from a 5 Volt DC USB port of a 60601 certified personal computer.
Cardiocity will provide circuit diagrams, component lists and descriptions to assist
service personnel in parts repair.
1.7

Manufacturer Address and Contact Details

Cardiocity Limited. Lab138, 9 St John's St, Colchester CO2 7NN, England, UK
Telephone +44(0)1206209039
1.8

Warnings, Cautions, Instructions and Notes

Read this user manual carefully, It is a component of the device and must be
available at all times:
• Only use the device for the described purpose.
• Read the user manual of the analysis software used with the RhythmPadGP ECG
acquisition platform.
• Observe the following for your own safety, as well as the safety of others.
RhythmPadGP Manual.doc 20/05/16
including revisions up to and including M5 Directive
CE Mark
GP
device from Cardiocity Limited, facilitates the frequently used
Cardiocity Limited – RhythmPad
GP
consists of a Clamshell type B-flute white
GP
and a USB cable along with
0120
GP
utilises novel active sensors to
GP
– User Guide- Page 7
GP
is