Cardiocity RhythmPadGP User manual

RhythmPadGP
User Guide

Cardiocity Limited – RhythmPadGP – User Guide- Page 2
RhythmPadGP Manual.doc 20/05/ 6
Useful Cardiocity phone numbers:-
Cardiocity Limited
Sales and service* (+44) (0) 203 209039
Fax (+44) (0) 206 7 0364
Email [e-mail]
Website http://www.cardiocity.com
*Before contacting Cardiocity for service enquiry please ensure that you have the product
serial number and the Software version.
The latest version of this manual (in Microsoft Word or PDF format) and RhythmPad
Software can be downloaded from the website www.cardiocity.com
Cardiocity has a policy of continuous product and documentation improvement. As such
the detail within this manual may not match the operation of the product this manual
describes.
These instructions were put together with great care. If you should still find discrepancies
in these Instructions for Use, which do not agree with how the RhythmPadGP operates, we
would appreciate it if you would contact us know so that we can correct the discrepancies
as quickly as possible. The specifications and figures in this manual are subject to change
due to technical further developments. All trademarks named and shown are trademarks of
the respective proprietor and are recognised as being protected. Reprinting, translation
and duplication require written permission of Cardiocity Limited.
No Liability for Consequential Damages - Cardiocity Limited has a policy of continuous
product and documentation improvement. As such the detail within this manual may not
match the operation of the RhythmPadGP device. In no event shall Cardiocity Limited be
liable for any direct, indirect, special, incidental, or consequential damages or loss
whatsoever (including, without limitation, damages for loss of profits, business
interruption, or other pecuniary loss) arising out of the use or inability to use the
RhythmPadGP device even if Cardiocity Limited has been advised of the possibility of such
damages. Because some jurisdictions do not allow the exclusion or limitation of liability for
consequential or incidental damages, the above limitation may not apply to you.
This User Guide is subject to the change control procedures of Cardiocity Limited. Reprint
and revision history: Version . produced May 20 6 ©20 0-20 6 Cardiocity Limited
Reprint and revision history:
First version CC 0 May 20 4
Uploaded to web 2 May 20 4

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# Description Page Number
.0 RhythmPad User Manual 5
. About 5
.2 Certification 6
.3 Packaging 7
.4 Transport Conditions 7
.5 Device Compliance and Intended Use 7
.6 RhythmPadGP Intended Use & Frequently Used Function 7
.7 Manufacturer Address and Contact Details 7
.8 Warnings, Cautions, Instructions and Notes 7
.9 General 8
. 0 Warnings 8
. Device Description 0
. 2 Purpose 0
. 3 RhythmPad Data 0
. 4 Monitoring the Data 0
. 5 Environmental Notice 0
. 6 EMC
. 7 Labels on the Device 4
. 8 Commissioning 4
. 9 Packing Caution 4
.20 Read Instructions for use Caution 4
.2 Cleaning & Disinfection 4
.22 Cleaning Caution 4
.23 Function Check 4
.24 Malfunctions and their rectification 4
.25 Maintenance and Servicing 5
.26 Disposal 5
.27 Replacement Parts 5
.28 Technical Data 5
.29 Warranty 6
.30 Administration of Data 6
2. How to set up a RhythmPadGP system from out of the box. 7
2. Connecting the RhythmPadGP to a suitable computer system 7
2.2 Minimum specification of host computer 8
2.3 Installing the software 8
3. Operating the RhythmPadGP using default settings 2
3. What happens when the system detects an abnormal Heart Rhythm 22
3.2 How to undertake a 6 lead screening 29
3.3 Printing and Emailing Records 30
3.4 Status Lights and Indicators 3
4. Configuring the RhythmPad software system 32
4. Understanding the configuration system 32
4.2 Changing the Language 33
4.3 Changing the Clinic Name 34
4.4 Changing where the RhythmPadGP sends its ECG data 34
4.5 Changing the Capture Duration 35
4.6 Changing the Bradycardia Threshold 35
4.7 Changing the Tachycardia Threshold 35
4.8 Changing the Default Screen Timeout 35
4.9 Changing the Theme 35
4. 0 Enabling/Disabling the Instructional Video 35
4. Enabling/Disabling the Exit Button 36
4. 2 Enabling/Disabling the Amber Results option 36

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4. 3 Enabling/Disabling the Anonymous Patient Function 37
4. 4 Changing the Print and Email options 37
4. 5 Changing the Patient ID type option 37
4. 6 Enabling the GP Email List option 37
4. 7 Changing the Capture Mode variable 37
4. 8 Enabling/Disabling the user to skip the Support Video 37
4. 9 Enabling/Disabling the Autostart Countdown feature 38
4.20 Switching between Attended and Unattended mode 38
4.2 Enabling/Disabling the Language Selection mode 38
5.0 ECG data captured by the RhythmPadGP 39
5. Reviewing the captured data 39
5.2 Cloud Connectivity 39
5.3 Data Protection 40
6.0 Support 40

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.0 RhythmPadGP User Guide
. About
The RhythmPadGP is a limb lead analysis tool for quickly and effectively capturing
electrocardiogram (ECG/EKG) data from a subject. The product was designed to allow
simple screening for cardiac rhythm and the identification of cardiac arrhythmias
through hand placement.
The system is designed to capture the ECG/EKG from the limb leads only.
Based on Einthoven’s triangle
above, the system has been
designed to be extendable from
the one lead hand placement
(leadI) system to a three lead
(leads I-III) through the
attachment of a left leg electrode.
The system can then calculate
leads IV-VI (aVR, aVL, aVF).
In normal hand placement only, the
RhythmPadGP collects a leadI ECG/EKG
from the patients hands. This is effective
for any subject that is not isoelectric when
measuring the ECG/EKG from the hands.
We estimate that 5% of all people using
the system will exhibit isolectric properties
and thus the system will not produce a
reading when working from the leadI
hands alone.
For these 5% of subjects the system must be used in
6 lead mode. To operate in 6 lead mode, the system is
extended using the plug in third electrode. The third
electrode is plugged in via the PS2 socket on the rear
of the RhythmPadGP and Velcro attached to the
subject’s left leg.
The RhythmPadGP can thus operate in either single or
6 lead modes which allows all subjects to be screened
for cardiac rhythm in thirty seconds.
The RhythmPadGP outputs the data via USB to any suitably equipped personal
computer where the data can then be analysed and displayed on screen.
Using the RhythmPadGP allows for simple limb lead analysis of a subject’s cardiac
performance. It cannot and should not be used for ECG/EKG analysis where the
subjects’ cardiac muscle performance required analysis. It is not a substitute for a
full 2 lead ECG system.
The system was not designed to acquire the V -V6 chest leads, as such the
RhythmPadGP can only be used as a screening tool for cardiac rhythm establishment
and the identification of cardiac arrhythmias.

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.2 Certification
The RhythmPadGP is certified as a Class2A Medical Device under the Medical Devices
Directive 93/42/EEC Annex II, Excluding Section 4. The RhythmPad Third electrode is
classified as a Class device.
The RhythmPadGP was certified by SGS UK Limited.

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.3 Packaging
The standard packaging for a RhythmPadGP consists of a Clamshell type B-flute white
corrugated 50/B/ 50 box, containing the RhythmPadGP and a USB cable along with
the Instructions for Use.
.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 0 % to 00 %, including condensation;
– an atmospheric pressure range of 50 kPa to 06 kPa.
.5 Device Compliance and Intended Use
This product is compliant with COUNCIL DIRECTIVE 93/42/EEC of 4 June 993
concerning medical devices including revisions up to and including M5 Directive
2007/47/EC of the European Parliament and of the Council of 5 September 2007
CE Mark 0 20
.6 RhythmPadGP Intended Use & Frequently Used Function
The RhythmPadGP device from Cardiocity Limited, facilitates the frequently used
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 RhythmPadGP utilises novel active sensors to
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 RhythmPadGP is
powered from a 5 Volt DC USB port of a 6060 certified personal computer.
Cardiocity will provide circuit diagrams, component lists and descriptions to assist
service personnel in parts repair.
.7 Manufacturer Address and Contact Details
Cardiocity Limited. Lab 38, 9 St John's St, Colchester CO2 7NN, England, UK
Telephone [phone]
.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.

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The following samples show how warnings, cautions, instructions and notes appear in
this document. The text explains their intended use.
WARNING: Warnings are directions which, if they are not followed,
can cause fatal or serious injuries to a user, engineer, patient or any
other person or can lead to a mistreatment.
CAUTION: Cautions are directions which, if they are not followed, can
cause damage to the system described in this manual.
ADVICE: Refer to instruction manual/ booklet
.9 General
The RhythmPadGP should be used in accordance with the following warnings and
cautions.
The RhythmPad
GP
device may only be used by persons who can
guarantee that it will be used properly based on their training,
education, or knowledge. Observe Section “CLEANING AND
DISINFECTION” for avoiding infections and bacterial contamination.
Before each use, visually inspect the device, the USB cable and
accessories. If there is any external visible damage or the device fails to
power up with the charger connected and power supplied, the device
may no longer be used.
All parts of the RhythmPad
GP
device, including supplied accessories,
which come into contact with the subject during intended use, meet the
requirements of the applicable standards with regards to bio-
compatibility, only allow repair work to be done by the manufacturer or
other authorised personnel
. 0 Warnings
The operation of the RhythmPadGP should be undertaken in accordance with the
following:
The RhythmPad
GP
device when operating with third party software should
only be used in accordance with the instructions for that software. The device
should be placed on a stable surface in close proximity or carried securely by
the subject.
Where accessories are attached to the subject, these accessories should only
be attached to the subject in a manner in accordance with the accessories
specific instructions.
Always consult accompanying Software Instructions for use in conjunction
with this product
Not to be used for screening patients under the age of 0, seek advice from
accompanying third party software.
Always select the most appropriate Limb placement model for patient
Use 3rd Electrode to verify screenings when supplied
Refer to 3rd Electrode Instructions prior to attaching sensor
Ensure Accompanying Software communicates with this device before
screening
Clean with Isopropyl Alcohol Wipes only
Do not use other liquids to clean device
Do not drop this device or place excessive load upon the device
Do not extend cables beyond their natural length

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Ensure subject is not still connected to the 3rd electrode before they leave
screening session
Place hands on device as shown in this manual
Ensure subject cleans hands before use
Ensure hand prints are legible to user before use
Ensure subject understands how to use the device before screening
This product is designed to be used with subjects with stable hands and with
normal limb arrangements
Ensure subject is supervised at all times during screening
Use product on a flat surface
Use device for screening purposes only
Use device for the period of time specified in the accompanying software
Always confirm abnormal screenings with a 2lead ECG
Ensure device is connected to a suitable USB socket
No user serviceable parts inside
Do not use in an oxygen rich environment
Ensure subject is detached from system in case of defibrillation
Device is designed to emit heat under the right hand print, measured in
testing at 46 deg C under the RH indicia
Cardiocity accept no liability for the interpretation of ECG data derived from
this product
The RhythmPad
GP
and it’s 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 in this accompanying document. It should be observed that
portable and mobile RF Communications equipment can affect MEDICAL
EQUIPMENT!
The RhythmPad
GP
can sense 0.076 millivolt changes in electric potential,
however it should be remembered that the amplitude of LeadI ECG when
measured from a subject’s hands will vary from patient to patient.
The ability for third party software to detect a patient physiological signal will
vary from patient, and from software vendor to software vendor.
The functionality and ability of this Medical Electrical Equipment when
working with third party software algorithms may cause inconclusive results
when generating leadI ECG information from patients who display low LeadI
amplitude when measured from the hands. It is advised in such cases to
utilise the 3rd Electrode accessory to acquire leads I,II and III from the
patient.
This equipment is intended for use by healthcare professionals only. This
equipment may cause radio interference or may disrupt the operation of
nearby equipment. It may be necessary to take mitigation measures, such as
re-orienting or relocating the RhythmPadGP or shielding the location.
The use of Accessories and cables other than those specified, with the
exception of accessories and cables sold by Cardiocity Limited, as the
manufacturer of the Medical Electrical Equipment as replacement parts for
internal components, may result in increased emissions or decreased
immunity of the Medical Electrical Equipment.
The RhythmPad
GP
should not be used adjacent to or stacked with other
equipment and that if adjacent or stacked use is necessary, the RhythmPadGP
should be observed to verify normal operation in the configuration it is to be
used.
Accessories, RhythmPad
GP
USB Cable, part number RPGPUSB00 and 3rd
Electrode, part number RPGP3RDELEC are the only accessories that should
be used with the RhythmPadGP

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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
. Device Description
The RhythmPadGP 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
RhythmPadGP and provide analysis of the subjects cardiac rhythm, and dependent
upon the software used in conjunction with the RhythmPadGP, can diagnose certain
arrhythmias that may be identified and established through a leadI reading.
The full diagnostics ability of the RhythmPadGP 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 RhythmPadGP alone. The
RhythmPadGP 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 RhythmPadGP 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
. 2 Purpose
The RhythmPadGP 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
v .0 is only to be used by a trained operator who
comply with instructions for installation, operation, storage and cleaning
. 3 RhythmPad Data
The RhythmPadGP emits a USB data stream in a serial data format, which can be
deciphered using LibUSB, an open source USB library.
. 4 Monitoring the Data
This User Manual details Cardiocity’s RhythmPad suite of ECG analysis software.
. 5 Environmental Notice
The RhythmPadGP 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.