RhythmPad
GP
User Guide
Страница 1: ...RhythmPadGP User Guide...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 41: ...Cardiocity Limited RhythmPadGP User Guide Page 41 RhythmPadGP Manual doc 20 05 16 NOTES...
