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

Cardiocity Limited – RhythmPadGP – User Guide- Page 3
RhythmPadGP Manual.doc 20/05/ 6
# 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

Cardiocity Limited – RhythmPadGP – User Guide- Page 4
RhythmPadGP Manual.doc 20/05/ 6
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

Cardiocity Limited – RhythmPadGP – User Guide- Page 5
RhythmPadGP Manual.doc 20/05/ 6
.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.

Cardiocity Limited – RhythmPadGP – User Guide- Page 6
RhythmPadGP Manual.doc 20/05/ 6
.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.

Cardiocity Limited – RhythmPadGP – User Guide- Page 7
RhythmPadGP Manual.doc 20/05/ 6
.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.

Cardiocity Limited – RhythmPadGP – User Guide- Page 8
RhythmPadGP Manual.doc 20/05/ 6
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

Cardiocity Limited – RhythmPadGP – User Guide- Page 9
RhythmPadGP Manual.doc 20/05/ 6
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

Cardiocity Limited – RhythmPadGP – User Guide- Page 0
RhythmPadGP Manual.doc 20/05/ 6
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.

Cardiocity Limited – RhythmPadGP – User Guide- Page
RhythmPadGP Manual.doc 20/05/ 6
. 6 EMC
Special Instructions & Notes regarding the RhythmPadGP & Electromagnetic
compatibility (EMC) testing to EN6060 - -2:2007.
The RhythmPadGP has been tested regarding its ability to operate in an environment
containing other electrical/electronic equipment (including other medical devices).
The purpose of this testing is to ensure the RhythmPadGP is not likely to adversely
affect the normal operation of other electrical/electronic equipment and that other
electrical/electronic equipment is not likely to adversely affect the normal operation
of the RhythmPadGP.
Despite the testing of the RhythmPadGP that has been undertaken, normal operation
of the RhythmPadGP can be affected by other electrical/electronic equipment and
portable and mobile RF communications equipment. As the RhythmPadGP is medical
equipment, special precautions are needed regarding EMC (electromagnetic
compatibility).
It is important that the RhythmPadGP is configured and installed/put into service, in
accordance with the instructions/guidance provided herein and is used only in the
configuration as supplied.
The RhythmPadGP has been tested (and should be used only with) the USB cable
supplied. If the RhythmPadGP is used with USB cables other than supplied, this may
result in increased emissions or decreased immunity of the RhythmPadGP in relation
to EMC performance. It should also be noted that the USB cable provided with the
RhythmPadGP should not be used with other equipment. To do so may result in
increased emissions or decreased immunity of the other equipment in relation to EMC
performance.
The RhythmPadGP should not be used adjacent to, or stacked with, other equipment.
If adjacent or stacked use with other equipment is necessary, the RhythmPadGP and
the other equipment should be observed/monitored, to verify normal operation in the
stacked/adjacent configuration in which it will be used.
For the purposes of EN6060 - -2, the RhythmPadGP does not have an essential
performance. The user should be aware that if the RhythmPadGP is subject to
electrical/electromagnetic interference in the form of conducted and radiated RF
fields (EMC phenomena detailed in the specifications EN6 000-4-6 and EN6 000-4-
3/EN6 000-4-8 respectively), incorrect operation of the RhythmPadGP may occur in
the form of noise being present on measured waveforms or the RhythmPadGP may
cease to respond (3rd party software stops responding and the RhythmPadGP LED is lit
solid green). To correct this condition, the RhythmPadGP should be moved away from
any suspected sources of interference (with the USB cable disconnected and re-
connected, should the RhythmPadGP have ceased responding).
The user should also be aware that if the RhythmPadGP is subject to electromagnetic
interference in the form of Electrostatic Discharges (EMC phenomenon detailed in the
specification EN6 000-4-2), incorrect operation of the RhythmPadGP may occur in the
form of noise being present on measured waveforms or the RhythmPadGP may cease
to respond (3rd party software stops responding and the RhythmPadGP LED is lit solid
green). To correct this condition, the RhythmPadGP should be moved away from any
suspected sources of interference (with the USB cable disconnected and re-
connected, should the RhythmPadGP cease responding). In addition, should the hand
sensors be directly subject to Electrostatic Discharges in excess of 2kV, this may
result in permanent damage to the sensors (which would require service/repair).

Cardiocity Limited – RhythmPadGP – User Guide- Page 2
RhythmPadGP Manual.doc 20/05/ 6
To reduce the risk of permanent damage to the sensors, the procedure in section 3.2
of this manual should be followed at all times (i.e. the subject should firstly touch the
silver grounding discs with each hand, before touching the sensors directly).
Guidance and manufacturer’s declaration – Electromagnetic Emissions
The RhythmPad
GP
is intended for use in the electromagnetic environment specified below. The customer or
the user of the RhythmPadGP should assure that it is used in such an environment.
Emission test Compliance Electromagnetic environment -
guidance
RF emissions
CISPR
Group The RhythmPad
GP
uses RF energy only
for its internal function. Therefore, its RF
emissions are very low and are not likely
to cause any interference in nearby
electronic equipment.
RF emissions
CISPR
Class B The RhythmPad
GP
is suitable for use in all
establishments, including domestic
establishments and those directly
connected to the public low-voltage
power supply network that supplies
buildings used for domestic purposes
Harmonic emissions
IEC6 000-3-2
Not applicable
Voltage fluctuations /
flicker emissions
IEC6 000-3-3
Not applicable
Guidance and manufacturer’s declaration – Electromagnetic Immunity
The RhythmPad
GP
is intended for use in the electromagnetic environment specified below.
The customer or the user of the RhythmPadGP should assure that it is used in such an environment.
Immunity test IEC 6060 test level Compliance level Electromagnetic
environment - guidance
Electrostatic
discharge (ESD)
IEC6 000-4-2
± 6 kV contact
± 8 kV air
± 6 kV contact*
± 8 kV air
*Permanent damage
can occur to the
sensors above a level
of 2kV. The subject
should touch the silver
grounding discs before
touching the sensors
directly – see section
3.2 of this manual.
Floors should be wood,
concrete or ceramic tile. If
floors are covered with
synthetic material, the
relative humidity should be at
least 30%. To reduce the risk
of permanently damaging the
sensors above 2kV, the
subject should touch the
silver grounding discs before
touching the sensors directly
– see section 3.2 of this
manual.
Electrical fast
transient / burst
IEC6 000-4-4
± 2 kV for power supply
lines
± kV for input /
output lines
Not applicable Mains power quality should be
that of a typical commercial
or hospital environment.
Surge
IEC6 000-4-5
± kV line(s) to line(s)
± 2 kV line(s) to earth
Not applicable Mains power quality should be
that of a typical commercial
or hospital environment.
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines
IEC6 000-4-
<5% UT (>95 % dip in
UT)
For 0.5 cycle
40% UT (60 % dip in UT)
for 5 cycles
70 % UT (30 % dip in
UT)
for 25 cycles
<5% UT (>95 % dip in
UT)
For 5 s
Not applicable Mains power quality should be
that of a typical commercial
or hospital environment. If
the user of the RhythmPadGP
requires continued operation
during power mains
interruptions, it is
recommended that the
RhythmPadGP be powered
from an uninterruptable
power supply or a battery.
Power frequency
(50Hz)
Magnetic field
IEC6 000-4-8
3 A/m 3 A/m If incorrect operation occurs,
it may be necessary to
position the RhythmPadGP
further away from any
suspected sources of power
frequency magnetic fields.
NOTE UT is the a.c. mains voltage prior to application of the test level.

Cardiocity Limited – RhythmPadGP – User Guide- Page 3
RhythmPadGP Manual.doc 20/05/ 6
Guidance and manufacturer’s declaration – Electromagnetic Immunity
The RhythmPad
GP
is intended for use in the electromagnetic environment specified below. The
customer or the user of the RhythmPadGP should assure that it is used in such an environment.
Immunity
test
IEC 6060
test level
Compliance
level
Electromagnetic environment - guidance
Conducted
RF
IEC6 000-
4-6
Radiated RF
IEC6 000-
4-3
3 Vrms
50 kHz to
80 MHz
3 V/m
80 MHz to
2.5 GHz
3 V
3 V/m
Portable and mobile RF communications equipment should
be used no closer to any part of the RhythmPadGP, including
cables, than the recommended separation distance
calculated from the equation applicable to the frequency of
the transmitter. Nevertheless, should incorrect operation
occur (in the form of interference present on waveforms), it
may be necessary to position the RhythmPadGP even further
away from suspected sources of electromagnetic fields.
Recommended separation distance (d)
d = .2√P
d = .2√P 80 MHz to 800 MHz
d = 2.3√P 800 MHz to 2.5 GHz
Where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation distance
in metres (m). Fields strengths from fixed RF transmitters,
as determined by an electromagnetic site survey, a should
be less than the compliance level in
each frequency range. b Interference
may occur in the vicinity of equipment
marked with the following symbol:
NOTE At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not
apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures,
objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which the
RhythmPadGP is used exceeds the applicable RF compliance level above, the RhythmPadGP should be
observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as re-orientating or relocating the RhythmPadGP.
b Over the frequency range 50 kHz to 80 MHz, field strengths should be less than 3 V/m.
Recommended separation distances between portable and mobile RF
communications equipment & RhythmPadGP
The RhythmPad
GP
is intended for use in an electromagnetic environment in which radiated RF disturbances
are controlled. The customer or the user of the RhythmPadGP can help prevent electromagnetic interference
by maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the RhythmPadGP as recommended below, according to the maximum output power of
the communications equipment.
Rated
maximum
output power
of transmitter
W
Separation distance according to frequency of transmitter (m)
50 KHz to 80 MHz
d = .2√P
80 MHz to 800 MHz
d = .2√P
800 MHz to 2.5
GHz
d = 2.3√P
0.0 0. 2 0. 2 0.23
0. 0.38 0.38 0.73
.2 .2 2.3
0 3.8 3.8 7.3
00 2 2 23.3
For transmitters rated at a maximum output power not listed above, the recommended separation distance
d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P
is the maximum output power rating of the transmitter in watts (W) according to the transmitter
manufacturer. NOTE At 80 MHz and 800 MHz, the separation distance for the higher frequency range
applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures objects and people.

Cardiocity Limited – RhythmPadGP – User Guide- Page 4
RhythmPadGP Manual.doc 20/05/ 6
. 7 Labels on the Device
The symbols on the type plate have the following meanings:
Read the Documentation Warning
European Conformity Type BF Applied Part
Keep Dry SN Serial Number
Dispose of in accordance with WEEE directive 2002/96/EC
Manufacturer details
. 8 Commissioning
Unpacking the device: Remove all components carefully from their packaging. Check
the components to make sure they are all complete (see Chapter .). Check all
components for damage. If components are missing or damaged, do not continue to
use the device. Contact your dealer or the manufacturer directly.
. 9 Packing Caution
Packaging material can pose a danger of suffocation. Keep it away from
children and dispose via the correct method.
.20 Read Instructions for use Caution
The user must consult manufacturer's instructions for use
.2 Cleaning & Disinfection
Only clean the RhythmPadGP device when it's USB cable is unplugged. Make sure that
no liquids can penetrate into the device. Wipe the housing with a soft, moist cloth.
For disinfection use ISOPROPYL alcohol cloth wipes
.22 Cleaning Caution
Never submerge the device in disinfectant or other liquid. The device may
become damaged if submerged in any liquid.
.23 Function Check
Every time the RhythmPadGP device is switched on it will perform a function check to
ensure everything is in order with its interfaces. This state of undertaking is relayed
to the user through a Solid Orange LED on the front face of the device. When
complete and communicating with appropriate third party software the system will
present a Solid Green LED to the user.
.24 Malfunctions and their rectification
Malfunction Cause of Error Rectification
The RhythmPad
GP
device
cannot be powered up
No power supplied via USB
socket
Check PC Power Supply
is on
The RhythmPad
GP
device
shows no LED light
The USB cable is not
plugged in
Check USB cable is
plugged into PC
The RhythmPad
GP
device
does not detect leadI
ECG
Patient has low amplitude
leadI ECG when measured
from their hands
Use 3rd Electrode
accessory to check leads
I-III

Cardiocity Limited – RhythmPadGP – User Guide- Page 5
RhythmPadGP Manual.doc 20/05/ 6
.25 Maintenance and Servicing
The RhythmPadGP contains no user serviceable parts, any maintenance of this device
must be carried out by the provider or manufacturer of the device.
.26 Disposal
The RhythmPadGP is an electronic medical device, it must be disposed of in
accordance with WEEE directive 2002/96/EC. Where applicable, equipment should be
decontaminated before disposal. When returning medical devices to the manufacturer
at end of life, or when transporting equipment, ensure that it is appropriately
packaged and secured.
.27 Replacement Parts
The RhythmPadGP has no replacement parts, it is sold as a complete unit. For
replacement please contact your provider or the manufacturer direct
.28 Technical Data
RhythmPad
GP
Feature Value
RhythmPad
GP
Dimensions in mm 35.2 x 80.6 x 44.8 mm
RhythmPad
GP
Weight 65 g
RhythmPad
GP
Temperature Range (User
Operation)
0 - 40 deg C
RhythmPad
GP
Air Pressure Range 700- 060hPa
RhythmPad
GP
Power Supply USB 5.0vDC supplied from 6060
compliant Personal Computer
Degree of protection against penetration
of water
No protection provided
Classification in accordance with
6060 .
Degree of protection against electric
shock
Class IIa device with Type BF applied
part
Methods of sterilisation or disinfection See section 3. 0 on Cleaning &
Disinfection
Where equipment is not suitable for use In Oxygen rich environments
Mode of operation Suitable for Continuous Operation
Pollution degree rating Pollution degree 2 (normal
atmosphere)
Data Transmission Up Stream Wired through USB 2.0 port
Electromagnetic compatibility (EMC) in
accordance with 6060 - -2 Noise
Suppression
-Immunity to Interference
RhythmPad
GP
conforms to the
requirements of IEC 6060 - -2 (EMC),
details for sensors may be found in the
user instructions or technical
specifications.
Variants No product Variants
Product Life The service life of the product is year
.29 Warranty
Cardiocity Limited guarantees that the product is free of defects if used as intended
for a time period of one year, starting from the date of purchase. The requirement for
warranty claims is the presentation of a receipt indicating the vendor and date of
purchase. Cardiocity Limited will extend no warranty in the following cases: - User
manual is not observed - Operating error - Improper use or treatment - Third Party
intervention in the device by non-authorised persons (e.g. for cleaning or repair
purposes) - Forces of nature, or circumstances beyond our control, such as lightning,

Cardiocity Limited – RhythmPadGP – User Guide- Page 6
RhythmPadGP Manual.doc 20/05/ 6
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.
.30 Administration of Data
The RhythmPadGP system is a medical device. This apparatus and it's accessories are
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 RhythmPadGP are required to store,
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.
.3 Certificate of Conformity
DECLARATION OF CONFORMITY
PRODUCT IDENTIFICATION
Product Name: RhythmPadGP Model Number: RP-GPv .0
MANUFACTURER
Cardiocity Limited, Lab 38, 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 0 20
CE Certificate Number: GB 3/90277
Date CE Marking First Applied: / / 4.
CONFORMITY ASSESSMENT
Device Classification: Class IIA Route to Compliance Annex II excluding section 4 Of
MDD, Rule 0 - 93/42/EEC Council Directive
Standards Applied: EN ISO 497 , EN ISO 3485, EN 6060 - , IEEE 073: 0406,
EN 6060 - -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 0/04/ 4

Cardiocity Limited – RhythmPadGP – User Guide- Page 7
RhythmPadGP Manual.doc 20/05/ 6
2. How to set up a RhythmPadGP system from out of the box.
The RhythmPadGP comes shipped in a sleeved cardboard packaging system
2. Connecting the RhythmPadGP to a suitable computer system
Remove the packaging sleeve and open the clam shell cardboard box to reveal the
RhythmPadGP.
Remove the RhythmPadGP and locate the USB cable and the Instructions for Use.
Identify if the RhythmPadGP was shipped with any removable computer media, such
as a CDROM, DVD or USB memory stick. If there is no removable media you will
need to download the software from www.cardiocity.com
Place the RhythmPadGP on a flat surface and connect the USB cable supplied to the
rear of the RhythmPadGP. The Micro USB end connects to the RhythmPadGP, whilst the

Cardiocity Limited – RhythmPadGP – User Guide- Page 8
RhythmPadGP Manual.doc 20/05/ 6
A size large USB male connects to the computer’s USB port.
2.2 Minimum specification of host computer
Cardiocity’s RhythmPad software suite is designed to operate on any Windows
Personal Computer or Tablet PC running Windows 7 or later.
It is an additional requirement that the system be equipped with Windows .NET
Framework 4.0 or later.
2.3 Installing the software
Having located the removable media or downloaded the RhythmPad software suite.
Launch the executable file choosing either the X86 or X64 installer dependent upon
your systems operating system. You will be presented with the installer window
below.
Accept the terms in the Licence agreement
The software then commences the installation process.

Cardiocity Limited – RhythmPadGP – User Guide- Page 9
RhythmPadGP Manual.doc 20/05/ 6
During this process Windows Security may ask if you want to install this device
software.
Select Install to allow the Cardiocity RhythmPad Software suite to be installed
Once past security the software setup process will prompt you to attach the
RhythmPadGP device, if you have not already.
At the end of the Software suite installation process the system will confirm that the
software has been installed and ask you to click on the Finish button to exit the setup
wizard.

Cardiocity Limited – RhythmPadGP – User Guide- Page 20
RhythmPadGP Manual.doc 20/05/ 6
The installation wizard should have placed an icon on your Windows desktop
Click on the Icon to Launch the Cardiocity RhythmPadGP software suite. Alternatively
using the Start icon to launch ALL PROGRAMS, if you look in the Cardiocity folder,
you will find a RhythmPadGP folder in which is located the same icon to launch the
software.