Summary of Contents for MyDiagnostick 1001R
- Page 1 MyDiagnostick 1001R - Device Manual UI0003-001 FINAL Revision 1 MyDiagnostick 1001R Device Manual Page 1 of 10...
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Page 2: Table Of Contents
MyDiagnostick 1001R - Device Manual UI0003-001 FINAL Revision 1 Table of Contents INTRODUCTION ................3 Intended use ........................3 Software ......................... 3 Regulatory information ....................3 Warnings ........................3 PACKAGING ..................4 Packaging symbols ......................4 DEVICE DESCRIPTION ..............5 Device label symbols ...................... -
Page 3: Introduction
FINAL Revision 1 1 Introduction Intended use The MyDiagnostick 1001R assists qualified medical personnel in diagnosing Atrial Fibrillation (AF). Software Use the appropriate MyDiagnostick software to configure and interrogate the device. Software is available from the MyDiagnostick website (www.mydiagnostick.com). Regulatory information... -
Page 4: Packaging
MyDiagnostick 1001R - Device Manual UI0003-001 FINAL Revision 1 2 Packaging Packaging symbols Symbol Explanation The device is compliant with European Union regulations regarding medical devices (NB 0344). Read the manual before operating the device. The packaging can and should be recycled. -
Page 5: Device Description
The product has to be recycled as an electrical appliance. Water splashing from any direction has no harmful effect (EN 60529). Visible signals The MyDiagnostick 1001R has 7 LEDs (Light Emitting Diode) to indicate device status, ECG (elec- trocardiogram) recording progress and AF (Atrial Fibrillation) detection status. Explanation Power (yellow) This LED is ON continuously during ECG recording. -
Page 6: Audible Signals
The MyDiagnostick 1001R has metal handles at both ends that serve as electrodes for ECG recor- ding. Computer interface The MyDiagnostick 1001R has a USB connecter (type Mini B) at one end to connect the device to a computer. Page 6 of 10... -
Page 7: Information For Health Care Professionals
ON. Preparing the device for first use Before making the first recording with the device, the user should use the device with the appropriate MyDiagnostick software to ensure that the device clock is set correctly. Page 7 of 10... -
Page 8: Information For Patients
(1 short beep) and start recording. The yellow LEDs show the progress of the recording. 3. Wait until the MyDiagnostick signals the end of the recording (2 short beeps). Either the green LED or the red LED will light to indicate the detection result. -
Page 9: Maintenance, Service And Warranty
The user should charge the device batteries regularly. 6.1.2 Service The MyDiagnostick 1001R does not contain any serviceable parts and cannot be opened. The expected battery life at intensive use is estimated at 5 to 10 years. 6.1.3 Limited warranty The warranty period is 2 years. -
Page 10: Technical Specifications
MyDiagnostick 1001R - Device Manual UI0003-001 FINAL Revision 1 7 Technical Specifications Mechanical Length 260 mm Diameter 22 mm Weight 180 g Electrical Batteries 2x NiMH 1.2V 2000 mAh rechargeable (not replaceable) Charge time (from depleted state) max. 10 hours Battery longevity min.
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