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UNEEG™ Home Data Manager

User Manual For Medical Professional And Patient | English |

7

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).

1. INTRODUCTION

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Summary of Contents for UNEEG

Page 1: ...UNEEG HOME DATA MANAGER User Manual for Medical Professional and Patient ...

Page 2: ......

Page 3: ... of a computer and a USB stick Figure A The Data Manager system connects to the 24 7 EEG SubQ hereafter named SubQ device Please refer to the specific instructions for use supplied with the SubQ device The data stored on the SubQ device are downloaded using the Data Manager system which saves the data on a USB stick for easy sharing with your medical professional FIGURE A ...

Page 4: ...r 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 Only use the supplied USB stick with the supplied computer For medical professionals It is recommended to have an anti virus program installed on computers used to access USB sticks with patient data ...

Page 5: ...2 Attach The Power Adaptor 11 3 3 Turn On Computer 12 3 4 Connect The SubQ Device 13 3 5 Attach USB Stick 14 3 6 Transfer Data And Charge Your SubQ Device 15 3 7 Data Transferred 16 3 8 Change SubQ Device 18 3 9 Sending Data To Your Medical Professional 20 3 10 Returning The Data Manager System 22 4 HOW TO USE MEDICAL PROFESSIONALS GUIDE 23 4 1 First Patient Visit 23 4 2 Schedule Next Patient Visi...

Page 6: ...For Medical Professional And Patient 5 MAINTENANCE 25 5 1 Handling 25 5 2 Cleaning 25 5 3 Disposal 25 5 4 Malfunctioning Devices 26 5 5 Product Life Time 26 5 6 Travelling 26 6 TROUBLESHOOTING 27 7 TECHNICAL DESCRIPTION 29 8 SYMBOLS AND MARKINGS 31 ...

Page 7: ...r User Manual For Medical Professional And Patient English 7 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 1 INTRODUCTION ...

Page 8: ...mputer to be placed in a regular wall socket is supplied with the Data Manager system USB sticks The Data Manager system is supplied with two USB sticks During use one must be plugged into the computer One USB stick has the capacity to store EEG data for up to 3 months The Data Manager System has an interface for connecting the 24 7 EEG SubQ FIGURE B SubQ device The SubQ device is worn to record E...

Page 9: ...UNEEG Home Data Manager User Manual For Medical Professional And Patient English 9 1 2 5 4 3 FIGURE B 2 1 3 4 5 Warning Only connect the supplied parts to the computer ...

Page 10: ...OME 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 Place the computer on the surface and open the lid 3 HOW TO USE PATIENT GUIDE ...

Page 11: ...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 4 Let the power adaptor stay connected to the computer as the computer needs power supply during the entire period to function ...

Page 12: ...e power button for 2 seconds FIGURE D 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 After 1 hour on battery the computer will go in sleep mode If the power cable is plugged in the computer will not go in sleep mode ...

Page 13: ...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 2 Attach the SubQ device ...

Page 14: ...tach the USB stick The computer will automatically start transfer of data from the SubQ device FIGURE G If the USB stick is already mounted the Data Manager system will proceed to next step and start to transfer data 2 Keep the USB stick connected to the computer until you send the data to your doctor as agreed See section 3 9 Do not remove the USB stick on a daily basis ...

Page 15: ...onents 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 A progress bar will indicate when data is transferred 3 6TRANSFER DATA AND CHARGE YOUR SUBQ DEVICE ...

Page 16: ...ppears 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 2 Leave the SubQ device connected to the computer to allow it to charge 3 When fully charged the green light on the SubQ device stops flashing and lights solid green ...

Page 17: ...ou can find the lights and sounds associated with charging and low battery levels in the Instructions for use for the SubQ device The SubQ device should be charged whenever it is not in use The battery life when fully charged is minimum 24 hours Note If the SubQ device is not fully charged at least every 30 days the internal clock might become incorrect Note The SubQ device will turn off while cha...

Page 18: ...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 1 Remove the SubQ device from the computer 2 Prepare that SubQ device for wearing by attaching an adhesive pad to the disc 3 Remove the SubQ device you are wearing 4 Connect that SubQ device to the computer ...

Page 19: ... 6 5 Wear the prepared SubQ device as instructed in the SubQ device 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 Using the same SubQ device for several days can lead to low battery level ...

Page 20: ...SIONAL 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 2 Find the second USB stick supplied with the Data Manager system 3 Prepare an envelope to send the USB stick to your medical professional ...

Page 21: ...eed 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 Note When you visit your medical professional the USB stick you sent will be given back to you Do not replace the USB stick currently in use when you ...

Page 22: ...onal The computer the SubQ devices and the USB stick all contain data When you return the Data Manager system make sure that the medical professional receives One computer with power adaptor Two USB sticks You may already have mailed one of the USB sticks to your medical professional One or more SubQ devices with wall adaptor and USB cable Please return the Data Manager System components in their ...

Page 23: ...Press in the software on the computer to set the language 2 Consider handing out pre addressed padded envelopes which the patient can use to send the USB stick with data 3 Fill out the address you would like to receive the USB stick at 4 HOW TO USE MEDICAL PROFESSIONALS GUIDE Note In order to comply with GDPR rules Do not insert the patient name on the envelope as it will contain health data 4 2 S...

Page 24: ...SB stick to return to patient at next patient visit Note Please note that files are named with the implant ID Note Please note that files from more patients can be transferred to the same destination folder Note Make sure to delete data on the USB stick before returning it to the patient 4 4 PATIENT VISIT Remember to hand over the USB stick to the patient to ensure continued logging 1 Instruct the...

Page 25: ...s See environmental conditions in 7 TECHNICAL DESCRIPTION 5 2CLEANING For the computer and the USB stick normal conditions for home use electronics apply For the SubQ device please refer to the specific user manual 5 3 DISPOSAL The SubQ device and all electronic accessories must be disposed according to the EU directive 2012 19 EU WEEE It is advised that the medical professional return the Data Ma...

Page 26: ...onsible medical professional 5 5PRODUCT LIFE TIME The Data Manager system is designed to be used for 6 months During the product life time the Data Manager system does not need service or calibration 5 6TRAVELLING In addition to ensuring that you have an appropriate adapter voltage converter when it is needed to power the Data Manager System there are no special precautions to take ...

Page 27: ...ange the USB stick and contact your medical professional See section 3 9 Other error Disconnect the SubQ device and contact your medical professional The computer informs that hard drive is full The storage capacity of the computer is full Contact your medical professional The computer informs that USB stick is full No more free storage space on the USB stick Replace USB stick with another UNEEG m...

Page 28: ...uter and turn on the computer See section 3 2 and 3 3 You may need to resume the data transfer from the SubQ device See section 3 6 The computer has been turned off Turn the computer back on by pressing and holding the power button See section 3 3 The computer screen informs to connect USB stick No UNEEG USB stick is connected Connect the supplied UNEEG USB stick to the computer or contact your me...

Page 29: ...ter 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 Environmental Conditions The following are the allowed environmental conditions for the Data Manager system and accessories Relative Humidity 8 to 80 Temperature 5 C to 35 C ...

Page 30: ...with installed UNEEG Home Data Manager Software The software will start automatically when the computer is turned on The computer will charge the SubQ device when connected Power adaptor A power adaptor is supplied with the Data Manager system The power adaptor will charge and power the computer UNEEG USB stick USB stick USB stick formatted to be recognised by the UNEEG Home Data Manager software ...

Page 31: ...al 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 Not for general waste Warning Messages with this heading indicate serious adverse reactions potential safety hazards and inadequate performance of device Consult instructions for use Temperature limits Humidity limits ...

Page 32: ...Nymøllevej 6 3540 Lynge Denmark www uneeg com 2020 UNEEG medical 0344 2019 2020 09 Rev IFU 10007 3 ...

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