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Cardiocity RhythmPadGP, User Manual, Page: 27 / 41

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Cardiocity RhythmPadGP User Manual Download Page 27

 Cardiocity Limited – RhythmPad

GP

 – User Guide- Page 27

 

 

 

 

RhythmPadGP Manual.doc 20/05/16 

 

 

 
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. 
 

Summary of Contents for RhythmPadGP

Page 1: ...RhythmPadGP User Guide...

Page 2: ...e 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...

Page 3: ...nt Parts 15 1 28 Technical Data 15 1 29 Warranty 16 1 30 Administration of Data 16 2 How to set up a RhythmPadGP system from out of the box 17 2 1 Connecting the RhythmPadGP to a suitable computer sys...

Page 4: ...he GP Email List option 37 4 17 Changing the Capture Mode variable 37 4 18 Enabling Disabling the user to skip the Support Video 37 4 19 Enabling Disabling the Autostart Countdown feature 38 4 20 Swit...

Page 5: ...tem 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...

Page 6: ...20 05 16 1 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 classif...

Page 7: ...om 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 r...

Page 8: ...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 othe...

Page 9: ...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 f...

Page 10: ...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...

Page 11: ...hythmPadGP 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 monito...

Page 12: ...Electrostatic discharge ESD IEC61000 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...

Page 13: ...nes 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 transmitte...

Page 14: ...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 1 22 Cleaning Caution Never...

Page 15: ...cation in accordance with 60601 1 Degree of protection against electric shock Class IIa device with Type BF applied part Methods of sterilisation or disinfection See section 3 10 on Cleaning Disinfect...

Page 16: ...f 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 accordan...

Page 17: ...n 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 compute...

Page 18: ...nning 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 downloade...

Page 19: ...t 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...

Page 20: ...hould 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 Car...

Page 21: ...ounded to the system This is done in the unlikely event that the user is carrying an electrical static charge To discharge any excess charge we ask that the user place their thumbs on the silver groun...

Page 22: ...ed 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: ...ide Page 23 RhythmPadGP Manual doc 20 05 16 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 Th...

Page 24: ...wo 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 w...

Page 25: ...is provided such that the user may place their hands on the RhythmPadGP in time before the screening takes place The operator of the device should not touch accessible parts of the USB connector or a...

Page 26: ...p of the sensing squares located in the middle of the circular pads Alternate Method 3 If the subject suffers from Essential Tremor or other physiological conditions that prevents the hands being laid...

Page 27: ...RhythmPadGP Manual doc 20 05 16 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...

Page 28: ...pared This can take some time dependent upon the performance of the system If the system is set to attended mode in the configuration then the ECG trace will be shown If you click on the Zoom in butto...

Page 29: ...t Rhythm When the RhythmPadGP system discovers an abnormal Heart Rhythm the system will respond by not displaying a green tick but a red question mark or if the ShowAmberResults config option is set t...

Page 30: ...output displayed after the capture as follows 3 3 Printing and Emailing Records The RhythmPad Software suite will present the user with options to Print or Email if the PrintAndEmailOption is set to O...

Page 31: ...pecified in the configuration file as soon as the system is connected to the Internet 3 4 Status Lights and Indicators The LED on the front of the RhythmPadGP is a Bi Colour indicator of the RhythmPad...

Page 32: ...at C Program Files Cardiocity RhythmPad GP If the user double clicks on this file it will normally open in a browser window and display its contents which typically look like xml version 1 0 encoding...

Page 33: ...4 2 Changing the Language This is the default language that the kiosk will operate in and the language that will displayed predominantly upon the screen at start up It is important to understand that...

Page 34: ...urgery name such that when the user operates the software they will see a screen as below during their user experience Changing the ClinicName allows for the User interface to be tailored to your orga...

Page 35: ...n a subject is in a state of Bradycardia The default setting for TachycardiaThreshold is 100 but this variable can be set to a value between 60 and 200 4 8 Changing the Default Screen Timeout DefaultS...

Page 36: ...removal of the exit button is recommended for people operating unattended systems to prevent the user switching off the system The system displaying the Exit Button in the top right hand corner 4 12...

Page 37: ...sion Initials The patient initials input screen will be shown instead during a session 4 16 Enabling the GP Email List option UseGPEmailList is a feature that when the system is being used in a surger...

Page 38: ...clinical staff present The two options for this variable are true where the sessions will follow the attended flow This includes results screens with ECG traces and options for emailing and printing...

Page 39: ...RhythmPadGP system an immediate view of all of the captures recorded The PNG images of all of the captures can be found at C Users ComputerName MyDocuments Cardiocity RhythmPadGP Captures PrintOutput...

Page 40: ...personal data is explicitly recognised also in Article 8 of the Charter of Fundamental Rights of the European Union Under the heading Protection of personal data Article 8 stipulates Everyone has the...

Page 41: ...Cardiocity Limited RhythmPadGP User Guide Page 41 RhythmPadGP Manual doc 20 05 16 NOTES...

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