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Table of Contents
Summary of Contents for EEG UNEEG
- Page 1 UNEEG™ HOME DATA MANAGER User Manual for Medical Professional and Patient...
- Page 3 UNEEG™ Home Data Manager PRODUCT OVERVIEW FIGURE A The UNEEG™ Home Data the specific instructions for Manager (hereafter named use supplied with the SubQ Data Manager system) device. consists of a computer and a (Figure A). USB stick The data stored on the SubQ...
- Page 4 UNEEG™ Home Data Manager WARNINGS AND PRECAUTIONS WARNINGS • Only supplied accessories may be connected to the Data Manager system. • The USB cable supplied with SubQ device may only be used with Data Manager system and SubQ device. PRECAUTIONS When using the Data Manager system, take note of the following: •...
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Page 5: Table Of Contents
UNEEG™ Home Data Manager CONTENTS 1. INTRODUCTION......7 Intended Use ......7 2. - Page 6 UNEEG™ Home Data Manager 5. MAINTENANCE ......25 Handling ......25 5.2 Cleaning .
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Page 7: Introduction
UNEEG™ Home Data Manager 1. INTRODUCTION 1.1 INTENDED USE The intended use of the UNEEG™ Home Data Manager is transfer of EEG data from UNEEG SubQ device to portable storage media (USB stick). User Manual For Medical Professional And Patient | English |... -
Page 8: Data Manager System Description
EEG data for up to 3 months. The Data Manager System has an interface for connecting the 24/7 EEG™ SubQ (FIGURE The SubQ device is worn to record EEG SubQ device data from the implant. The USB cable connects the SubQ device to the computer. - Page 9 UNEEG™ Home Data Manager FIGURE B Warning • Only connect the supplied parts to the computer. User Manual For Medical Professional And Patient | English |...
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Page 10: How To Use: Patient Guide
UNEEG™ Home Data Manager 3. HOW TO USE: PATIENT GUIDE 3.1 PLACEMENT AT HOME 1. Find a suitable level surface that can accommodate the computer and one SubQ device. Choose a spot close to a free power socket, as the Data Manager system will need power during the entire use period to function properly. -
Page 11: Attach The Power Adaptor
UNEEG™ Home Data Manager 3.2 ATTACH THE POWER ADAPTOR FIGURE C 1. The computer must always remain connected to the keyboard as shown in FIGURE C (laptop mode). 2. Attach the power adaptor in the wall socket. 3. Plug the power cable into the computer. -
Page 12: Turn On Computer
UNEEG™ Home Data Manager 3.3 TURN ON COMPUTER FIGURE D 1. Press and hold the power button for 2 seconds (FIGURE 2. Wait for the Data Manager system to start up. Note: The computer has the following battery saving modes when screen is not activated: After 5 minutes the screen will turn of. -
Page 13: Connect The Subq Device
UNEEG™ Home Data Manager 3.4 CONNECT THE SUBQ DEVICE FIGURE E The computer prompts for connection to the SubQ device. 1. Use the USB cable supplied with SubQ device and connect it to the computer. If the USB cable is connected to the wall adapter you will need to disconnect the USB cable from the wall adaptor before connecting to the computer. -
Page 14: Attach Usb Stick
UNEEG™ Home Data Manager 3.5 ATTACH USB STICK FIGURE F The computer prompts for connection to the USB stick. 1. Attach the USB stick. The computer will automatically start (FIGURE G). If the USB transfer of data from the SubQ device stick is already mounted the Data Manager system will proceed to next step and start to transfer data. -
Page 15: Transfer Data And Charge Your Subq Device
UNEEG™ Home Data Manager 3.6 TRANSFER DATA AND CHARGE YOUR SUBQ DEVICE FIGURE G When all components are connected to the Data Manager system, data is downloaded to the computer. The computer automatically processes the data and stores it on the USB stick to be reviewed later by your medical professional. -
Page 16: Data Transferred
UNEEG™ Home Data Manager 3.7 DATA TRANSFERRED FIGURE H When the data is successfully transferred, the progress bar disappears and a message to leave the SubQ device plugged in until fully charged is shown. 1. Check on screen, that the data was successfully transferred. In case of an error follow the instruction displayed on the screen. - Page 17 UNEEG™ Home Data Manager It is now safe to remove the SubQ device. You are advised to leave it plugged in until you need to wear the SubQ device. You can find the lights and sounds associated with charging and low battery levels in the Instructions for use for the SubQ device.
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Page 18: Change Subq Device
UNEEG™ Home Data Manager 3.8 CHANGE SUBQ DEVICE FIGURE I If more than one SubQ device is in use, it is advised to set a daily routine for changing SubQ devices and connect the just worn SubQ device to the computer for charging and download of data. - Page 19 Instructions for use. Note: The SubQ device has a battery life of minimum 24 hours when fully charged and the capacity to store EEG data for up to 1 month. Note: Be careful not to mix up the SubQ devices when changing.
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Page 20: Sending Data To Your Medical Professional
UNEEG™ Home Data Manager 3.9 SENDING DATA TO YOUR MEDICAL PROFESSIONAL FIGURE J After a period of time agreed with your medical professional, you can send the recorded data to your medical professional. 1. Make sure that data transfer is not in progress. - Page 21 6. Mail the envelope containing the USB stick as agreed with your medical professional. The medical professional can then review your EEG before your next visit. Note: Be careful not to mix up the USB sticks, as sending an empty USB stick will cause a delay in the medical professional receiving your data.
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Page 22: Returning The Data Manager System
UNEEG™ Home Data Manager 3.10 RETURNING THE DATA MANAGER SYSTEM FIGURE K When it is time to stop using the Data Manager system, you must return it to your medical professional. The computer, the SubQ devices and the USB stick all contain data. -
Page 23: How To Use: Medical Professionals Guide
UNEEG™ Home Data Manager 4. HOW TO USE: MEDICAL PROFESSIONALS GUIDE *Note: In order to comply with 4.1 FIRST PATIENT VISIT GDPR rules; Do not insert the 1. Hand over the Data Manager system to the patient name on the envelope as it will contain health data. -
Page 24: Accessing Patient Data
UNEEG™ Home Data Manager 4.3 ACCESSING PATIENT DATA 4.4 PATIENT VISIT When you receive the USB Remember to hand over the stick, the data is preprocessed USB stick to the patient, to to EDF+ files with a unique ensure continued logging. -
Page 25: Maintenance
UNEEG™ Home Data Manager 5. MAINTENANCE The Data Manager system is 5.3 DISPOSAL a valuable part of optimising The SubQ device and all you treatment and should be electronic accessories must be treated with care. This section disposed according to the EU contains information on how directive 2012/19/EU (WEEE). -
Page 26: Malfunctioning Devices
UNEEG™ Home Data Manager 5.4 MALFUNCTIONING 5.5 PRODUCT LIFE TIME The Data Manager system DEVICES If the Data Manager system is designed to be used for 6 seems to be malfunctioning, months. contact your responsible medical professional. During the product life time,... -
Page 27: Troubleshooting
UNEEG™ Home Data Manager 6. TROUBLESHOOTING See Table 1 for information on how to react in different situations. Table 1: Troubleshooting Problem Possible cause Possible solution SubQ device is Reconnect the SubQ device. disconnected. See section 3.4. Reconnect the USB stick See section 0. - Page 28 See section 3.3. No UNEEG USB stick Connect the supplied is connected. UNEEG USB stick to the computer or contact your medical professional. The computer screen informs to connect Invalid USB stick not...
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Page 29: Technical Description
Power Source Only use the supplied charger to charge the computer. Modification No modification of the equipment is allowed. Only the UNEEG Home Data Manager application can run on the computer. Repairs The SubQ device contains no replaceable or repairable parts. - Page 30 Power adaptor system. The power adaptor will charge and power the computer. UNEEG™ USB stick USB stick formatted to be recognised by the UNEEG™ USB stick Home Data Manager software. | English | User Manual For Medical Professional And Patient...
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Page 31: Symbols And Markings
UNEEG™ Home Data Manager 8. SYMBOLS AND MARKINGS Manufacturer Date of manufacture Use-by date Batch number Catalogue number Serial number CE marking: Declaration that the product meets all the safety, health, and environmental protection requirements for CE marking and can be sold throughout the EEA. - Page 32 Nymøllevej 6 3540 Lynge Denmark www.uneeg.com 0344 2019 © 2020 UNEEG™ medical 2020/09 Rev. IFU-10007-3...