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Cardiocity RhythmPadGP User Manual

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User Guide

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Summary of Contents for Cardiocity RhythmPadGP

  • Page 1 RhythmPad User Guide...
  • Page 2 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 1.1 produced May 2016 ©2010-2016 Cardiocity Limited...

  • Page 3: Table Of Contents

    Cardiocity Limited – RhythmPad – User Guide- Page 3 Description Page Number RhythmPad User Manual About Certification Packaging Transport Conditions Device Compliance and Intended Use RhythmPad Intended Use & Frequently Used Function Manufacturer Address and Contact Details Warnings, Cautions, Instructions and Notes General 1.10...
  • Page 4 Cardiocity Limited – RhythmPad – User Guide- Page 4 4.13 Enabling/Disabling the Anonymous Patient Function 4.14 Changing the Print and Email options 4.15 Changing the Patient ID type option 4.16 Enabling the GP Email List option 4.17 Changing the Capture Mode variable 4.18...

  • Page 5: Cardiocity Limited - Rhythmpad

    Cardiocity Limited – RhythmPad – User Guide- Page 5 RhythmPad User Guide About The RhythmPad 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.

  • Page 6: Certification

    Cardiocity Limited – RhythmPad – User Guide- Page 6 Certification The RhythmPad 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 Class1 device.

  • Page 7: Packaging

    • 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.

  • Page 8: General

    Cardiocity Limited – RhythmPad – User Guide- Page 8 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.
  • Page 9 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 and it’s accessories are MEDICAL ELECTRICAL EQUIPMENT.

  • Page 10: Device Description

    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 and accessories are MEDICAL ELECTRICAL EQUIPMENT.

  • Page 11: Emc

    Cardiocity Limited – RhythmPad – User Guide- Page 11 1.16 EMC Special Instructions & Notes regarding the RhythmPad & Electromagnetic compatibility (EMC) testing to EN60601-1-2:2007. The RhythmPad has been tested regarding its ability to operate in an environment containing other electrical/electronic equipment (including other medical devices).
  • Page 12 Cardiocity Limited – RhythmPad – User Guide- Page 12 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).
  • Page 13 Cardiocity Limited – RhythmPad – User Guide- Page 13 Guidance and manufacturer’s declaration – Electromagnetic Immunity The RhythmPad is intended for use in the electromagnetic environment specified below. The customer or the user of the RhythmPad should assure that it is used in such an environment.

  • Page 14: Labels On The Device

    Cardiocity Limited – RhythmPad – User Guide- Page 14 1.17 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 Serial Number Dispose of in accordance with WEEE directive 2002/96/EC Manufacturer details 1.18 Commissioning...

  • Page 15: Maintenance And Servicing

    The service life of the product is 1 year 1.29 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.

  • Page 16: Warranty

    – User Guide- Page 16 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.

  • Page 17: How To Set Up A Rhythmpad

    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 RhythmPad on a flat surface and connect the USB cable supplied to the rear of the RhythmPad .

  • Page 18: Minimum Specification Of Host Computer

    A size large USB male connects to the computer’s USB port. 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.
  • Page 19 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 RhythmPad device, if you have not already.
  • Page 20 Click on the Icon to Launch the Cardiocity RhythmPad software suite. Alternatively using the Start icon to launch ALL PROGRAMS, if you look in the Cardiocity folder, you will find a RhythmPad folder in which is located the same icon to launch the software.

  • Page 21: Operating The Rhythmpad Gp Using Default Settings

    To start a screening, simply click on the icon on the desktop, or launch the program from the start menu -> All programs -> Cardiocity. It is important at this stage to ensure that the user is grounded to the system. This is done in the unlikely event that the user is carrying an electrical static charge.

  • Page 22: What Happens When The System Detects An Abnormal Heart Rhythm

    Cardiocity Limited – RhythmPad – User Guide- Page 22 This language selection is only visible in the default settings and can be removed by editing the config file. See section 4. The system now prompts you to start by clicking with a mouse, or touching the screen if using a touch screen display, on the large Touch here to start button.
  • Page 23 Cardiocity Limited – RhythmPad – User Guide- Page 23 A screen now asks the user to use alcohol gel to clean their hands A screen now checks to see if the user is registered with the medical practice/surgery The user now enters their date of birth.
  • Page 24 Cardiocity Limited – RhythmPad – User Guide- Page 24 The user is now asked to enter two initials for identification purposes. A back button is provided if the user wishes to return to the previous screen. The user is then asked to select their sex. A back button is provided if the user wishes to return to the previous screen.
  • Page 25 Cardiocity Limited – RhythmPad – User Guide- Page 25 The instructional video is then displayed to the user with an avatar showing the user how to place their hands on the RhythmPad . If the user has selected that they are male then the avatar will be male.
  • Page 26 Cardiocity Limited – RhythmPad – User Guide- Page 26 Normal Method 1. The RhythmPad has been designed to acquire a leadI ECG from a subject's hand placement over the sensor pads. The prime positioning of the subjects hands over the sensors is via the...
  • Page 27 Cardiocity Limited – RhythmPad – User Guide- Page 27 The screening then commences and the first notification screen is then displayed. After ten seconds the second notification screen is then displayed. After 20 seconds the third and final notification screen is displayed.
  • Page 28 Cardiocity Limited – RhythmPad – User Guide- Page 28 When the thirty seconds are complete then a holding screen is displayed as the results are being analysed and the printouts being prepared. This can take some time dependent upon the performance of the system.

  • Page 29: How To Undertake A 6 Lead Screening

    If the system is operating in unattended mode, then no ECG trace is given, but wherever possible a reassurance to the user is given along with their Heart rate. Cardiocity accept no liability for the interpretation of the data by the user. As a company we recommend always confirming any cardiac abnormality with a full 12 lead ECG system.

  • Page 30: Printing And Emailing Records

    Cardiocity Limited – RhythmPad – User Guide- Page 30 If the user now presses the 6 Lead key a 6 lead reading will be undertaken with the output displayed after the capture as follows: Printing and Emailing Records The RhythmPad Software suite will present the user with options to Print or Email if PrintAndEmailOption is set to Optional in the configuration file.

  • Page 31: Status Lights And Indicators

    Internet. Status Lights and Indicators The LED on the front of the RhythmPadGP is a Bi-Colour indicator of the RhythmPad 's system status. The LED is located in the centre of the "o" of the red "Cardiocity"...

  • Page 32: Configuring The Rhythmpad Software System

    To ensure and maintain quality Cardiocity Limited only release one version of software which can be configured by the user to operate in a wide range of settings. To customise the RhythmPad system to the user’s requirements a configuration file is used.

  • Page 33: Changing The Language

    Cardiocity Limited – RhythmPad – User Guide- Page 33 Once the user has the config file open then each of the attributes of the RhythmPad system may be edited. If for example the user wishes to set the Bradycardia Threshold (the heart rate...

  • Page 34: Changing The Clinic Name

    CloudEmailAddress is the email address of where to send the report. The default for this variable is set to ecg@cardiocity.com but should be changed to the operators email address or the email address where the operator wants all reports to be sent to.

  • Page 35: Changing The Capture Duration

    > 4.10 Enabling/Disabling the Instructional Video ShowInstructionalVideo variable controls whether Cardiocity’s default video is played to show the user how to place their hands on the RhythmPad . There are two acceptable states for this variable to be in true and false. When true the video is played, when false it is skipped.

  • Page 36: Enabling/Disabling The Exit Button

    Cardiocity Limited – RhythmPad – User Guide- Page 36 The instructional video showing the user how to place their hands on the RhythmPad 4.11 Enabling/Disabling the Exit Button ShowExitButton variable controls whether the system presents a red exit X box in the top right hand corner of the application.

  • Page 37: Enabling/Disabling The Anonymous Patient Function

    Cardiocity Limited – RhythmPad – User Guide- Page 37 4.13 Enabling/Disabling the Anonymous Patient Function For the AnonymousPatient variable allows the user to set the system into anonymous mode. When this variable is set to true, print-outs and emails will not show an ID (either patient initials or hospital ID).

  • Page 38: Enabling/Disabling The Autostart Countdown Feature

    Cardiocity Limited – RhythmPad – User Guide- Page 38 4.19 Enabling/Disabling the Autostart Countdown feature UseAutostartCountdown variable can be set into two modes: true where the capture will be preceded by a countdown, continuing to the capture without user input and false where there will be no countdown screen before the capture time.

  • Page 39: Ecg Data Captured By The Rhythmpad

    Cloud Connectivity The RhythmPad software suite is designed to upload all readings to the Cardiocity cloud which is hosted on Microsoft Azure cloud. Microsoft Azure is a cloud computing platform and infrastructure created by Microsoft for building, deploying, and managing applications and services through a global network of Microsoft-managed data centres.

  • Page 40: Data Protection

    The only data that is sent to the cloud is the subjects’ initials, sex and date of birth. From this data, Cardiocity as an organisation cannot identify the subject, only the clinic where the subject is registered, if they are registered at all may be able to identify the subject from this data set.
  • Page 41 Cardiocity Limited – RhythmPad – User Guide- Page 41 NOTES: RhythmPadGP Manual.doc 20/05/16...

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