Home

MINAmI_WP7_D77_GE_TID_PU_NEW

1. EEG MDS 001 Initial Conditions Equipment is set up as per Equipment Setup section Step Full Regr Task amp Expected Result Run the Send data request on the mobile application Verify The mobile phone starts to receive the data from the base Verify The mobile application displays an information note when data has been received and proceeds automatically to sending the data to the server Verify The data transfer begins and ends Repeat steps 40 to 42 Cancel the data sending to the server Verify The data is stored in the mobile phone to be sent at a later Pass Fail occasion ze Comments ej iss e Ce T cere E Peo cS CC a i z 129 aT P sit jj lt u ve inet E 434 Tester Date 132 133 Doc name MINAm WP7 D7 7v2 Date 13 11 2009 ID D7 7v2 Security Confidential Revision Final Page 56 60 Contract IST 034690 Deliverable report WPO7 D7 7v2 141 Doc name ID D7 7v2 pN MINAml Frontal EEG Logger J6 GE Healthcare Verification Protocol LI MINAMI e t 3 Test Case ID EEGLOG T72 06 o Description Visualize data Applicable for EEG data logger Requirements EEG MDS 002 EEG MDS 004 EEG MDS 005 EEG MDS 007 EEG MDS 008 Initial Conditions Equipment is set up as per Equipment Setup section Task amp Expected Result Start a web browser and open the URL for the med ical server application
2. Verify username and password are requested Verify Access is denied when using a random username and or password Enter valid username and password Verify Access is granted to the server Comments eee Tester Date SS MINAmL WP7 D7 7v2 Date 13 11 2009 Security Confidential Revision Final Page 57 60 Contract IST 034690 FM e Deliverable report WPO7 D7 7v2 XR gh MINAm I Frontal EEG Logger Q3 GE Healthcare verification Protocol i E i E 15 15 141 Test Case ID EEGLOG T72 07 u Description View messages and patient notification 7 Applicable for EEG data logger l E Requirements EEG MOB 002 EEG MOB 005 EEG MDS 003 EEG MDS 004 EEG MDS 006 EEG MDS 007 Initial Conditions Equipment is set up as per Equipment Setup section Step Full Regr Task amp Expected Result Eme 51 Access the server with a web browser software 52 Verify Notifications can be sent to patients in SMS format ee i Pa Send SMS notification to a mobile phone 54 E Varify The mobile phone receives the SMS and is able to visualize it F to the patient 144 Comments 143 _ 144 145 Kite Ul 6 X 09 147 Tester Date 7 145 Doc name MINAmL WP7 D7 7v2 Date 13 11 2009 ID D7 7v2 Security Confidential Revision Final Page 58 60 Contract IST 034690 Deliverable report WPO7 D7 7v2 M4 VARTA Data Sheet Type Number System
3. ui MINAmI Micro Nano integrated platform for transverse Ambient Intelligence applications FP6 Contract IST 034690 e 0 a MINRmI e a WP07 Demonstration validation amp exploitation Deliverable report Deliverable ID D7 7v2 m n na Deliverable Title ew amp Homecare demonstrator 2 Responsible partner GE TID Juha Virtanen GE l Miguel Angel Santiago Cabello TID SOHIIBULODS Eija Kaasinen VTT Hanna Lammi VTT PROPRIETARY RIGHTS STATEMENT This document contains information which is proprietary to the MINAMI Consortium Neither this document nor the information contained herein shall be used duplicated or communicated by any means to any third party in whole or in parts except with prior written consent of the MINAMI consortium s e0 MINAMI e Contract IST 034690 Deliverable report WPO7 D7 7 v2 Document Information MINAmlI WP7 D7 7v2 Document ID D7 7v2 V1 0 13 11 2009 Author GE TID Confidential Approvals COo T I Ws Technical Pascal ANCEY ST Fr Coordinator WP leader Miguel Angel Santiago Documents history Revision Date Modification Authors 08 05 2009 First draft 04 09 2009 Mobile phone application sections added Addition of GE contribution its installation guide V0 3 07 09 2009 and user manual and Evaluation results of the TID GE VTT sleep logger 15 09 2009 Addition of user evaluation from GE TID GE
4. u s Background 12 3 1 Purpose and Scope of the Test 13 3 2 Experience required 14 3 3 Test Items Equipment Needed 15 3 4 Estimated test time EPER 18 3 5 Reference Documents 17 3 6 Definitions T a 4 Preparing the Test Environment al 13 4 1 Equipment Setup 20 4 2 Test Instructions N DDD moooucoouQ Ba QoOCOO N H 5 Test Cases 22 5 Change history By Description of changes o o 13 Aug 2009 P La eseripton version i 14 Aug 2009 F Lapiniampi ML ctions suggested by Juha Virtanen l H14 Au 2008 J Virtanen Typographical corrections Bit a4 en Date 13 11 2009 Security Confidential Page 45 60 Doc name MINAmL WP7 D7 7v2 ID D7 7v2 Revision Final e Contract IST 034690 Deliverable report WP07 D7 7v2 a diam MINAml Frontal EEG Logger d GE Healthcare Verification Protocol 3 15 z 1 Test Information 1 1 Test type X Full Test Regression Test a 1 2 Test Equipment 1 2 1 Test Device write also serial ID numbers EEG logger l OO uo Logger Base eo i zo Power Supply Mert el _ Cc 3 t a 33 Mobile Phone VAS OSS 825 a 1 2 2 Test Software versions 3 Analyzesleep exe lo i x Logger2edf exe 2 5 s MINAmI T7 2 sisx pork x 1 3Test Personnel Jotak x Name dott eA U mh uw Das t 56 o Time h Sies H es A T
5. The user can send SMS to registered patients to inform about results and medical appointments Figure 33 Micro Nano integrated platform for transverse Ambient Intelligence applications Patient Carlile Megan Mobile number 0034626635651 Manage SMS 20 01 2009 13 50 08 Poor signal quality please repeat the measurement tonight Figure 33 SMS sent to patients Doc name MINAmL WP7 D7 7v2 Date 13 11 2009 ID D7 7v2 Security Confidential Revision Final Page 25 60 e Contract IST 034690 Deliverable report WP07 D7 7 v2 MINAm e Section 5 Test Report 5 1 Verification Document MINAmI Frontal EEG Logger Verification Protocol in Annex 1 includes test cases with test results for verifying the requirements as specified in the following documents D 12 Final demonstrator requirements D 13 Functional description of the final demonstrators D7 14 Test amp validation plan for the final set of demonstrators The requirements and respective test results are also summarized below Lithium battery test results can be found in D4 13 In summary the demonstrator has fulfilled the requirements set for it and has successfully passed the respective test cases Having met the technical goals the demonstrator has also achieved the main goal which was to develop a functional system for user evaluation EEG Logger Requirement TAG Description Status Comments EEG LOG 001 No user operated switches o
6. Nominal Voltage V Nominal Capacity C mAh Typical Capacity C mAh at B mA 1 00 V Weight approx g Dimensions mm Diameter d Height h T UL Recognition d Coding Temperature Ranges C Storage less than J0 days Discharge Charge Charging Method Normal Charging Accelerated Charging 20 C Fast Charging Trickle Charging Overcharge 20 C Charge Retention 4 at 20 C t o MINAMI e V 40H Rechargeable Ni MH Button 55604 Nickel Metal Hydrides KOH Electrolyte 1 2 40 43 1 7 min max 11 3 11 5 5 05 5 35 MH 13654 N Manufacturing 5 digit code 123 day 4 year 5 version min 4 20 0 ggg 4 m for 14 16 h 8 m for 7 8 h 20 mA for 3h Time controlled voltage control recommended 1 2 mA 4 mA continuous 8 mA upto 1 year 90 Capacity available after 1 month Storage at 20 C Internal Resistance Ohm 3 at charged cells 20 C DC 0 2 CA 2 CA IEC 61951 2 Impedance Ohm 0 42 at charged cells 20 C AC 1kHz IEC 61951 2 Typical Capacities mAh at 40 mA 0 90 V Max Discharge Current cont mA Life Expectancy typical IEC Cycle Trickle Charga Trickle Charge for fully discharged cells 20 C Capacities based on normal charging VARTA Microbattery GmbH Daimlerstrale 1 D 73478 Ellwangen Jegat Tel 49 7B61 821 0 Telefax 46 7961 021 553 Doc name MINAmL WP7 D7 7v2 ID D7 7
7. Placing the EEG Logger on Logger Base for data transmission Once Connect Phone LED starts blinking after about 15 20 minutes data is ready to be transmitted to medical server T7 2 MINAmlI application is available in the Applications folder on the mobile device s menu see Figure 13 Activate the MINAml mobile application by selecting the appropriate icon 4 3 Mobile device application Environmental needs 4 3 1 Sleep logger and Reader amp Charger prototype to test functionalities Bluetooth for communications A running HTTP web server for communications Internet connection through GRPS or Wi Fi access point Mobile device with signed MINAml T7 2 application installed Open T7 2 application T7 2 MINAmI application is available in the Applications folder on the mobile device s menu See Figure 13 x Applications t j e Office Screenshat JoikuSpot Y Share online MyNokia MINAmI TT 6 TL r Figure 13 Application T7 2 Doc name MINAmL WP7 D7 7v2 Date 13 11 2009 ID D7 7v2 Security Confidential Revision Final Page 15 60 e Contract IST 034690 i J Deliverable report WPO07 D7 7 v2 psc 4 3 2 Start the application When the user runs the MINAml T7 2 application a dialog is displayed to select the access point to be used in data transfer to server See Figure 14 i MINAMI 17 2 D Default access point O Easy WLAN Figure 14 A
8. They should not get scared after the first measurements but several successive measurements should be made 5 3 6 5 Development ideas Four test users pointed out that the logger should be smaller The smaller the better Two of them suggested that the logger could be thinner if the snap connectors on the electrodes were replaced with some other solution The users also suggested that the material of the logger could be more elastic e g a band In the final workshop these ideas were discussed and it was concluded that a band may however not be as good a solution as a separate device on the forehead Three test users proposed that on the logger base there could be a hollow where the logger would fit This would ensure the right positioning and also would prevent moving the logger accidentally One user also suggested that a separate LED indicating the logger positioned correctly would help 8 One of the test users 4 thought that the appearance of the logger will need attention Current appearance brings into one s mind horror movies it may feel frightening and it may give the impression that is conducts electronic current to the body The user may wonder how the logger will influence one s brain overnight The test user gave the following suggestions to be considered in designing the logger 1 The logger should not look too technical 2 The logger should not be transparent electronics should be hidden from sight d The col
9. Figure 9 Server response Section 4 User manual This section explains how the users patient healthcare provider shall use of the demonstrator system The system consist of the components illustrated in Figure 10 Logger Base Power supply EEG Logger Figure 10 EEG Logger system components 4 1 Sleep recording The EEG Logger You just received is normally in so called stand by mode red led blinks once in ten seconds The EEG Logger detects automatically that you attach it on your forehead and start the recording the led blinks once in a second If the light is not blinking place the EEG Logger on the Logger Base see Figure 12 for some 10 seconds O Wash your face with soap Do not use face cream O Attach three electrodes to the EEG Logger First snap an electrode to the EEG Logger or the cable only then remove the plastic shield from the adhesive Doc name MINAmI WP7 D7 7v2 Date 13 11 2009 ID D7 7v2 Security Confidential Revision Final Page 13 60 Contract IST 034690 sius Deliverable report WP07 D7 7 v2 INfimi e O O Attach the EEG Logger on the forehead The orange cable on low left The lower edges of the electrodes shall be about 1 2 cm above eyebrows The EEG Logger shall be horizontally centered See Figure 11 Ensure good contact by pressing the edges of the electrodes with fingertips Attach the third electrode on the tip of the cable on the temple on the eye line The red LED
10. tae oats RNC ratr mersit 1 mor ILOT MC esd Hor lecare 8 Le 218 B8 i35 ator Dr Howards Sylvia Patient data Name ER Surname Date of 12 02 1961 Age birth Sex Mobile number MINENKEE user MEE Password shifts Notes Figure 30 Patient personal data information In the same way the files received from each patient are available to the user Figure 31 and Figure 31 Micro Nano integrated platform for transverse Ambient Intelligence applications th monitoring amp Homecare demonstrator Patient Carlile Megan Mobile number 0034626635651 Manage files Text Parameter file Carlile Megan 06022009 1011 par Image Sleep graphic file Carlile Megan 06022009 1011 1 jpg ic fi i ic fi 06 02 2009 10 11 56 generated files Image Sleep graphic file Carlile Megan 06022009 1011 2 jpg 10 06 2009 15 42 56 generated files Text Parameter file Carlile Megan 10062009 1535 par Image Sleep graphic file Carlile Megan 10062009 1535 1 jpg Back Figure 31 Files related to a registered patient Doc name MINAm WP7 D7 7v2 Date 13 11 2009 ID D7 7v2 Security Confidential Revision Final Page 24 60 Contract IST 034690 iE e Deliverable report WP07 D7 7 v2 piss Micro Nano integrated platform for transverse Ambient Intelligence applications Patient Carlile Megan Mobile number 0034626635651 Image file Figure 32 Image related to patient data
11. 21 09 2009 Final version of the document TID GE 13 11 2009 Validation Pascal Ancey Doc name MINAmL WP7 D7 7v2 Date 13 11 2009 ID D7 7v2 Security Confidential Revision Final Page 2 60 o MNAmi e M md Contract IST 034690 Deliverable report WPO7 D7 7 v2 Section 1 Executive summary 1 1 Description of the deliverable content and purpose The main contents of this deliverable are the Installation Guide document and the User Manual document regarding the demonstrator created in Task 7 2 Health monitoring amp Homecare demonstrator for Phase Il The purpose of this deliverable is to help users to install and use the Sleep logger and Reader amp Charger prototype and the mobile application associated More specifically the Installation Guide section describes the steps needed to install and configure the Sleep logger and Reader amp Charger prototype and the Health monitoring amp Homecare mobile application On the other hand the User Manual section explains how the user should make use of the demonstrator Sleep logger and Reader amp Charger prototype and mobile application Therefore it describes the Sleep logger and Reader amp Charger prototype user interface and the mobile application user interface with the different options available to the user This document also contains a Test Report and a User Evaluation results related to Phase ll The Test Report specifies the test cases that have been tested In additio
12. 6 4 Name e Date IS TE J Time h 4 Name 3 a V Date 65 4 Time h 2 Doc name MINAmlI WP7 D7 7v2 Date 13 11 2009 ID D7 7v2 Security Confidential Revision Final Page 46 60 Contract IST 034690 xd e Deliverable report WPO7 D7 7v2 E MINAmI Frontal EEG Logger GE Healthcare Verification Protocol 4 15 2 2 Test Summary a 2 1 Results a4 Conclusion of the test PASS I FAIL 45 Identifiers of the observations recorded E an 43 s Total number of cases failed 51 pi Phe Se tae s Test Lead Approval AVU 6 260 hh E d 53 Date Signature i PETTEH LAP NC P 55 Doc name MINAm WP7 D7 72 Date 18 11 2009 ID D7 7v2 Security Confidential Revision Final Page 47 60 ID D7 7v2 Revision Final e e e Contract IST 034690 E a Deliverable report WP07 D7 7v2 id o are MINAm Frontal EEG Logger vig GE Healthcare Verification Protocol 9 15 s 3 Background amp 3 1 Purpose and Scope of the Test 57 This test will check that the Frontal EEG data logger fulfills the specifications of the 5n device defined in M1186205 s 3 2 Experience required eo Need to know how to use the EEG data logger and the HyperTerminal PC interface of E1 the logger base a 30 Test Items Equipment Needed 83 EEG data logger 84 Logger base 6E e Power supply Nordic power B6 e USB cable with mini USB connector for the logger base and a normal connector for B7 the PC Es Mobile
13. 60 Contract IST 034690 o MINAMI e Deliverable report WPO7 D7 7v2 E ru MINAmI Frontal EEG Logger 26 J GE Healthcare Verification Protocol 117 EEGLOG T72 04 Configuration of the mobile application EEG data logger EEG MOB 002 EEG MOB 006 Equipment is set up as per Equipment Setup section Test Case ID Description Applicable for Requirements Initial Conditions Task amp Expected Result Start the MINAm software on a mobile phone and turn on BlueTooth connectian p nd turn on BlueTooth Verify The phone detects the logger base and the BlueTooth pairing is successful Configure server settings in the mobile application Run the lest configuration request in ihe mobile application Verify The application sends the test configuration request and receives ACK confirmation from the server 118 Comments 122 E jal j X e t 1 3 Tester Date 124 Tz Doc name MINAmL WP7 D7 7v2 ID D7 7v2 Revision Final Security Date 13 11 2009 Confidential Page 55 60 e Contract IST 034690 dia Deliverable report WP07 D7 7v2 iNHmi e P ro MIN rmi Frontal EEG Logger ED GE Healthcare Verification Protocol P A 15 125 Test Case ID EEGLOG T72 05 Description Transfer data to server _ Applicable for EEG data logger Requirements EEG MOB 001 EEG MOB 002 EEG MOB 003 EEG MOB 004 EEG MOB 006
14. When selecting this option some setups regarding the web server are introduced here URL login password See Figure 24 Further information in 4 3 5 FS MINAMI T72 Configure server Figure 24 Server settings 4 3 3 3 Help This option gives information about the software version of the MINAmI T7 2 application 4 3 3 4 Exit Doc name MINAmI WP7 D7 7v2 Date 13 11 2009 ID D7 7v2 Security Confidential Revision Final Page 20 60 Contract IST 034690 di e Deliverable report WPO7 D7 7 v2 X scs If the user selects this option it has the same behaviour as the right soft key in the main view of the application the application is closed showing the Applications menu again of the mobile device 4 3 4 Exit In the bottom right part of the main view there is a soft key labelled Exit Clicking this key the application is closed asking for a confirmation See Figure 25 and showing the Applications menu again of the mobile device x o MINAMI T72 f Configured n Send data Sms Are you sure that you D want to quit the v application Figure 25 Exit confirmation 4 3 5 Options Server Configuration When selecting the soft key Options in Server Configuration view See Figure 24 the menu displays the following actions Change Test Configuration Help and Exit See Figure 26 Sa x f o MINAMI T7 2 E Configure server URL https minam1 fp6 t User user1 Test c
15. available The temple electrode was suggested to be smaller since now some hair was easily left under the electrode 2 The connecting point between the logger and the temple connectors wire was described robust 5 In the final product the joint was proposed to be somehow protected 5 One user 2 suggested that the temple connector could be wireless and he also proposed a device where all the electrodes would be a part of an integrated thing attached on the forehead Accordingly one user 3 suggested that the logger would not be attached on the forehead but somewhere else These comments highlight that that users may have not fully understood the measuring principle e g that the eye movement monitoring needs to be ear the eye It would be beneficial to describe these basic principles in the user guide The design of the logger was described harsh 3 As such the appearance may generate fears what the device is doing to one s brain during the night It is not obvious that the device is just measuring and not sending signals 4 However the users did understand the fact Doc name MINAmL WP7 D7 7v2 Date 13 11 2009 ID D7 7v2 Security Confidential Revision Final Page 34 60 s e0 MINAMI e Contract IST 034690 Deliverable report WPO7 D7 7 v2 that the sleep logger is still a proto and they commented that the ergonomic issues were clearly not yet considered Doc name MINAmL WP7 D7 7v2 Date
16. patient initiates data logging in the evening by attaching the Logger on his her forehead using adhesive electrodes For data readout from the logger memory in the morning the user puts the Logger on the Logger Base which automatically performs data readout and recharges the logger batteries The Mobile Phone is used to read the data from the base via Bluetooth and sending the data to Medical Server via 3G connection The Medical Server executes automatic analysis provides user interface for the physician and enables messaging with the patient s mobile phone The main content of this deliverable is the documentation needed for using the demonstrator system The Installation Guide describes the steps needed to install and configure the Health monitoring amp Homecare demonstrator system The User Manual section describes the basic flow of operation during a sleep study for the patient It also describes both the Logger Base user interfaces and the mobile application user interface with the different options available to the patient The User Manual also briefly describes for the physician the use of EEG Logger system and the Medical Server In addition the document consist test resutls In case of Health monitoring amp Homecare demonstrator there are three groups of tests Verification of the system againts test cases deved from requirements validation of the sleep analysis algorithm againts manual sleep stage scoring and finally user evaluatio
17. phone with Symbian S60 3 edition software equipped with the MINAmI Ba software 70 ECG electrodes CFM 00 5 50 n Computer equipped with analyzesleep exe loggerZedf exe HyperTerminal and a 73 web browser software Mozilla Firefox 3 0 or newer IEB or newer 5 3 4 Estimated test time 74 3 days 5 3 5 Reference Documents 78 M1186205 D7 12 Final demonstrator requirements Extract from the original T7 document including Sleep Quality Analysis T7 2 only x 3 6 Definitions 78 EEG Electroencephalography Bd TC Test Case Doc name MINAmI WP7 D7 7v2 Date 13 11 2009 Security Confidential Page 48 60 Contract IST 034690 i e Deliverable report WPO7 D7 7v2 X ns MINAm Frontal EEG Logger GE Healthcare Verification Protocol LLL 88 4 Preparing the Test Environment a 4 1 Equipment Setup 83 Connect the logger base to mains via the power supply Ba Check that the power LED is lit on the logger base B5 Check that the EEG logger is in standby mode i e the LED is blinking every ten EE seconds If not place the logger on the base for ten seconds and check again aw 4 2 Test Instructions 88 To connect the logger base to a PC with the USB cable the computer must have USB e serial drivers installed Doc name MINAmL WP7_D7 7v2 Date 13 11 2009 ID D7 7v2 Security Confidential Revision Final Page 49 60 Contract IST 034690 i e Deliverable report WPO7 D7 7v2 xs MINAml Fron
18. the temple with a wire and suggested that all the electrodes could be on a row on the forehead In the guidance it was not explained that the temple electrode was registering eye movement and thus necessary to be positioned on the temple It would be beneficial to inform users about the basic principles of the device e g in the guidance With one user 4 the electrodes caused itching and the user was wondering if the adhesive was commonly causing this kind of symptoms Two users suggested that better feedback of the progressing of the data transfer would be needed One of them 3 suggested graphical feedback with a small LCD unit on the box One of the other users 5 told that the LEDs were sufficient in following the transfer progress One user 2 suggested that the logger base could be battery operated Three users suggested that the mobile phone could be left away and the logger base could take care of transmitting the data to the server One of them 5 suggested that if the mobile phone is included the phone could provide some added value like showing the data on the screen Another user 2 also suggested that some feedback a graph how did sleep could be provided to the user right away In the final workshop it was emphasised that also history data is important especially in home use The user can then identify how his her habits affect the quality of sleep Two users suggested that the device could have both home versi
19. there was a common meeting with the test users and researchers at GE The users were informed about the study and the logger and how it should be used Each participant filled in a background questionnaire that studied expectations and motivations They also signed a research permission Also the test and interview schedule was agreed Each test user used the logger overnight In the next morning the user filed in a questionnaire about how s he slept and how the logger felt The user took the logger with him her to the working place where s he uploaded logged data to the logger phase Finally the user transferred the data from the logger base to a mobile phone that was part of the test equipment and used the MINAml application on the phone to send the data to the remote server to be analysed After carrying out the data transfer the user continued filling in the questionnaire concerning user acceptance of uploading The next day after the data transfer the user had an appointment with a sleep analysis expert who showed and explained to the user the results of the analysis The user got the sleep analysis with him her on paper The final interview was made by phone The focus of the interview was on user acceptance of the system The final interview was based on the test user feedback only for privacy reasons the evaluator did not have access to the recorded data or the sleep analysis VIT researchers analysed the evaluation results and produce
20. 13 11 2009 ID D7 7v2 Security Confidential Revision Final Page 35 60 e Contract IST 034690 T ow Deliverable report WP07 D7 7 v2 MINAMI e 5 3 6 2 Data transfer Data transfer was clearly the more challenging part of using the sleep logger Table 1 5 illustrates the feedback that the users gave with the questionnaire right after they had carried out the data transfer oeveral users highlighted the need for the accurate placement of the logger on the logger base The users wanted to be certain about the right location of the logger on the base station It was also brought out that an accidental push may move the logger and thus interrupt the transfer if the logger is not firmly placed A slot or a hole on the base station was suggested to help to place the logger correctly A separate green LED light was suggested to indicate that the logger is connected and starts to transfer data Figure 40 Placing the EEG logger on logger base for data transmission left and the labels on the base right The LEDs were seen helpful but not considered informative enough A small LCD display on the box was suggested to be useful to facilitate text information A progress bar on the logger base was also proposed Also the LED colours should be considered more carefully The red and orange LED colour gives the impression that something is wrong One user 1 was confused since in the written instructions there was an inaccuracy about pow
21. 5 2 Algorithm CFI OPIN GING Desueessucuserueseenidixsumissseueruususatras2cEuuwrsunuEEc guru rds osuauE Ese duse durius 28 5 3 User Evaluati OM et M 28 rcm M select 28 2 a2 igi 812 oe ey eee E eee eer eee ee eee ee eee 28 5 3 3 Technical setup of the demonstrator cece ce ceecceceeeeeeeeeeeeseeeeesaeeeeeseeeeeseeeeeas 29 534 ION DI OCGOU arses o teu a nse needa i EEEN 30 5 3 5 Results of the expert evaluation cccecccsseeccssecceeeeceseeceeseeceeeceeeenseeessaeeseaees 31 5 3 6 Results of the user evaluation seeseeeeseeeseeeseeeeneeneeennn nnn 32 S00 OMICS ONS exeseiimimi E Prodr d Iva su UE SUUM M dI M CN EID NM EE 43 Annex MINAml Frontal EEG Logger Verification Protocol 44 Doc name MINAmI WP7 D7 7v2 Date 13 11 2009 ID D7 7v2 Security Confidential Revision Final Page 5 60 o MNAmi e M md Contract IST 034690 Deliverable report WPO7 D7 7 v2 Section 2 Introduction Health monitoring amp Homecare demonstrator was developed to assess the feasibility of the concept of ultra light physiological data logger in sleep disorder studies In the basic form the patient uses the EEG Logger for collecting EEG and acceleration signal overnight and sends the data for automatic analysis using Logger Base and mobile phone The system enables repeated measurements and provides feedback between recording sessions The
22. 6 Measure the dimensions of the logger Pass Fail Height O mm length 90 _ mm width IO mm Expected values height less than 40 mm length less than 80 mm width less than 20 mm 27 Check the maximum number of recharging events of the logger i Pass Fail r batteries from their data sheet UCO times Expected result at least 100 Observe the logger base T f Ti Verify The base comprises a single entity including reader and Fail charger Verify The base has indicator LEDs for main functions and an error Fail LED Observe the sleep analyzer software on a PC Verify The software accepts input data file name as a parameter Rass Fail Pass Fail Verify The software writes the analysis results in multiple files l Doc name MINAmI_WP7_D7 7v2 Date 19 11 2009 ID D7 7v2 Security Confidential Revision Final Page 53 60 E Contract IST 034690 T ow Deliverable report WP07 D7 7v2 u MINAmlI Frontal EEG Logger GE Healthcare Verification Protocol 11 15 ahh Gel Steou Co h s Comments 27 Boco ao c does cel T 7 c coe Weft ste Macd goestef Cate d 113 feck 2 c fc ker res chen Ee ves sac e po 114 Ass UG BAL 115 Tester Date 023 hs laf ached AS o6 e c ae terat T iii see Noos not atte Jo perforo ce of slap seda Doc name MINAm WP7_D7 7v2 Date 13 11 2009 ID D7 7v2 Security Confidential Revision Final Page 54
23. 7 7v2 Date 13 11 2009 ID D7 7v2 Security Confidential Revision Final Page 31 60 s e0 MINAMI e Contract IST 034690 Deliverable report WPO7 D7 7 v2 If the transmission gets stuck exit the MINAml mobile application remove the Logger from the Base and reset the Base by plugging it off and on Then put the Logger back on the Base and start from 6 again ooftware changes were required to use the error LED only for actual errors not to indicate that the logger battery needed recharging during the data transfer The SMS acknowledgement message Night recording correctly received waiting for doctor analysis was suggested to be more specific It would be beneficial to check that the recording is technically valid long enough In that case it might be good to give feedback on the length as well e g Sleep data for 8 5 hours received waiting for doctor analysis The correct position of the logger on the top of the logger base was marked with a sticker to ease positioning the logger correctly 5 3 6 Results of the user evaluation 5 3 6 1 Sleep monitoring Ease of use of the sleep logger Usage of the sleep logger was described straightforward 3 easier than thought 5 and exciting 1 Generally setting up the sleep logger in the evening went smoothly and without bigger problems It was described quick 1 effortless 2 and plug and play 5 One user 3 pointed out that h
24. He was confused as he thought that the mobile phone is sending data not receiving Doc name MINAmL WP7 D7 7v2 Date 13 11 2009 ID D7 7v2 Security Confidential Revision Final Page 37 60 Contract IST 034690 Ps Deliverable report WPO7 D7 7 v2 Xo Three of the five users 2 4 5 were wondering why the mobile phone was needed The phone was described additional 4 unnecessary 5 and an intermediate grade 4 One user commented It felt pointless to transfer data several times 5 The sleep logger together with the logger base was seen adequate in the future Users had trust in data transfer None of the test users had concerns regarding the reliability of the transfer The sleep data as such was not felt confidential Most of the users were familiar with data transfer and had some experience This helped them to trust the transfer They felt that a third party would have no use of the data It is not money related data or a doctor s certificate 2 5 3 6 3 Sleep analysis The sleep analysis data consisting of graphs and the textual feedback shown in Figures 1 5 and 1 6 was explained privately to each test user by a sleep analysis expert The sleep analysis supported and opened up many users assumptions about their sleeping One user 3 was especially interested in the information about awakenings in small hours After hearing the sleep analysis he pieced together that the sleep is normally gettin
25. al interface that data transmission is interrupted when the logger is lifted and continued when the logger is put back on the base Check the content of the logger memory _ amp amp H ate A Expected result memory empty all P after 10 minutes orc m Pass Fail 1 Comments 108 A e U S a s 106 Tester Date Doc name MINAmL WP7 D7 7v2 Date 13 11 2009 ID D7 7v2 Security Confidential Revision Final Page 52 60 e e e Contract IST 034690 E Deliverable report WP07 D7 7v2 X dh o T MINAmI Frontal EEG Logger 1 G6 GE Healthcare Verification Protocol 10 15 l o 106 10 Test Case ID EEGLOG_T72_03 Desc ription Observational test of the system Applicable for EEG data logger Requirements EEG LOG 002 EEG LOG 003 EEG LOG 006 EEG LOG 009 EEG CHR 001 EEG CHR 002 EEG ANL 003 Initial Conditions Equipment is set up as per Equipment setup section Step Full Regr Task amp Expected Result Observe the material and surface structure of the logger Verify the material specification indicates that the material is smooth ass Fail to facilitate cleaning withstands disinfectants and is biocompatible Attach the logger to the forehead B T Verify no other parts than the electrode contacts are in contact with Pa amp s Fail the skin 235 Measure the weight of the logger Pass I Fail Weight 60 g Expected value less than 50g 2
26. blinking red LED of the logger did not disturb him or others sleeping in the same room Doc name MINAmL WP7 D7 7v2 Date 13 11 2009 ID D7 7v2 Security Confidential Revision Final Page 33 60 e Contract IST 034690 Deliverable report WP07 D7 7 v2 MINAm e Based on the users own estimation four of the five users had no difference in the amount of sleep during the test night compared to their normal night One user 4 normally sleeps 8 10 hours a night and during the test night she slept 6 8 hours Comfort of use Number of users no 1 2 3 4 5 6 7 1 totally disagree 7 totally agree Figure 39 The logger felt more comfortable than the users expected The sleep logger was described surprisingly comfortable 4 and more unnoticeable than thought 5 However the logger was also claimed to be big 1 heavy 1 and not comfortable 3 It was hoped that the device would be smaller lighter and more elastic It was commented that the logger should not be any bigger sideways not to disturb sleeping One user 4 suffered from itching on her forehead during the night because of the adhesives Nonetheless as she removed the adhesives in the morning the itching ended and did not bother her any more during the next day She suggested researching if there were diverse types of clues that would not cause itching Comment from the final workshop there are actually various alternatives
27. ccess Point Selection If there isn t any configured data logger the application starts a Bluetooth device discovery procedure x TS MINAMI T7 2 Configured Send data Searching i EEG logger s Figure 15 Searching data logger The user can cancel this procedure or select one of the found devices in this case the configuration with the selected data logger is established The status of the configuration Configured Not Configured is set in the upper part of the main view as follows Doc name MINAmI WP7 D7 7v2 ID D7 7v2 Revision Final Date 13 11 2009 Security Confidential Page 16 60 a Contract IST 034690 E Deliverable report WP07 D7 7 v2 ne 5 MINAMIT7 2 g configured D rT Send data d View messages Figure 16 MINAml T7 2 main window The main window displays two items Send data and View messages Following each item is described in detail 4 3 3 Options In the bottom left part of the main view there is a soft key labelled Options Clicking this key a menu is presented with the following actions See Figure 17 Select Configure Help and Exit x TS MINAMI T7 2 Configured D L Send data m View messages Configure Help Exit Figure 17 Options The user can interact with the application through this menu The user can select one action or cancel the menu showing the main view again Following each action is described in detail 4 3 3 1 Selec
28. d a draft evaluation report These results were presented to GE people in a workshop In addition to the project personnel two test users the medical supervisor of the evaluation and two clinicians participated in the workshop The workshop participants discussed the results and proposed development ideas 5 3 5 Results of the expert evaluation The expert evaluations revealed some issues in the user guide to be refined The evaluations also revealed some usability problems in the logger and logger base These problems were fixed before the user evaluations as described in the following In the user guide the meaning of the blinking and then continuously illuminated LED in the logger base under Connect phone was specified Blinking Connect Phone tells that data is ready to be transmitted to medical server for analysis Once the data has been transmitted the LED is illuminated continuously Equally a notice was added to emphasize that the logger should not be removed from the base when recharging was going on IMPORTANT Do not remove the logger from the base after the downloading to facilitate battery charging Each time you replace the logger on the base the downloading starts from the beginning During downloading the Charging led will be off and on by turns The continuous charging starts only after downloading has been completed We also added instructions in case the transmission gets stuck Doc name MINAmL WP7 D
29. dless since the red LED was still blinking in the morning one user 2 was uncertain if he could begin with the data transfer Evaluator comment This should be instructed in the user guide Sleep quality Number of users 1 2 3 4 5 6 7 1 totally disagree 7 totally agree Figure 38 The users felt that the logger did not disturb their sleep much As a whole the users slept well with the sleep logger However they did have some presuppositions of not falling easy to sleep with the logger and one user 4 described that she almost panicked before going to bed She was afraid that she may not easily fall asleep with the logger One user 3 said that at first it felt weird to go to sleep with a logger on the forehead Anyhow he slept well One user described forgot the existence of the logger in a few minutes 2 The users would be ready to use the sleep logger for several nights One user 5 stated l could imagine using the logger even for a week Four of the five users felt that the existence of the logger did not disturb or harm their sleeping One user 1 who according to her own experience did not sleep well estimated that 1096 of the restlessness of her sleep was due to the sleep logger and 9096 since she had a period of restless sleep going on One user 2 also mentioned that he had to adjust the pillow so that the logger did not press against his head One user 5 pointed out that the
30. e data transfer Number of users NO 1 2 3 4 5 6 7 1 totally disagree 7 totally agree Figure 41 User feedback of the data transfer Problems occurred mainly in the data transfer between the logger base and the mobile phone Almost all 4 5 test users told that data transfer was stuck One user 2 even had to call the technical support at GE to help and reset the system The user told that if technical support would not have been available he would not have known what to do In the following the users describe their expressions of data transfer The first data transfer did not succeed it got stuck waited about an hour 1 There was a real stuck situation with the phone 2 interrupted the data transfer and started again 3 It did not succeed on the first try 4 This was almost too easy since it was so automatic 5 Two users 1 4 mentioned that the acknowledgement message did not arrive One of them 1 transferred the data again because she did not know if the first try was successful Despite the problems in data transfer the users gave quite good grades to the ease of transferring the data This may be due to the good user guide with which most users could solve the problem There were several phases in data transfer This confused users For example one user 2 was confused about the indication Receiving data when starting the data transfer with the mobile phone
31. e set the temple electrode by mistake on the right side of his forehead This was firstly because he is right handed and instinctively put the electrode to the right side and secondly since one looks himself in the mirror as mirror image even if the photo in the instructions shows the electrode on the left side Evaluator comment this could be fixed if the correct position is marked with up down rather than left right ow Number of users no 1 2 3 4 5 6 7 1 totally disagree 7 totally agree Figure 37 Taking the logger into use was felt quite easy Doc name MINAmI WP7 D7 7v2 Date 13 11 2009 ID D7 7v2 Security Confidential Revision Final Page 32 60 e Contract IST 034690 Deliverable report WP07 D7 7 v2 MINAm e One user 4 mentioned that it took some time before the logger started collecting data She tried to press the electrodes against her forehead thinking that this would help to activate the contact She pointed out that it should be mentioned in the instructions that it takes a while before the LED starts blinking and the connection is actually activated Comment from final workshop The start up may take up to 10 minutes The user guide was updated with this information after the two first test users Detaching the logger in the morning was found easy and straightforward No problems occurred One user 5 described Detaching was easy since didn t have to switch off anything Regar
32. echnology 2009 The overall agreement between the four stage automatic scoring and manual scoring was 79 1 x 0 67 The values were at the level of typical inter scorer agreement Prediction probability value of Entropy was 0 89 The sensitivity and positive predictive values were 70 and 74 for wakefulness 59 and 86 for REM sleep 87 and 79 for light sleep and 86 and 81 for slow wave sleep respectively The performance of the sleep scoring algorithm was equivalent to similar developments reported in literature The key findings have also been published in a conference poster and abstract Wireless Forehead EEG Logger And Automatic Sleep Stage Scoring Virtanen J Sipponen S Lapinlampi P Paraschiv lonescu A Lamy J Salmi T Meril inen P SLEEP Volume 32 Abstract Supplement 2009 A378 5 3 User Evaluation 5 3 1 Introduction The sleep quality analysis demonstrator was evaluated in August 2009 with five test users The users were GE employees as this kind of a prototype medical device could not be put to consumer evaluations The objective of the evaluations was to get preliminary feedback on user acceptance of the concept as well as to test the technical functionality of the logger and the analysis software The user evaluation was organised in cooperation by GE and VTT GE took care of the technical setup and user support user guidance and sleep analysis VIT took care of designing the questionnaires interviewing the use
33. eeeeeeeee nennen nnn nnn nhan 7 3 2 Mobile device application Lees Lees eese reee eene nnne nnn 8 3 2 1 Option 1 Nokia PC Suite s install applications ssseeesseeeeesss ss 9 3 2 2 Option 2 Windows Explorer s Nokia Phone Browser 10 a29 Update ICO n NEN RE TEE 11 Su Moala ieS ssenassacubCcamdspEEr E DU DUM M DEI DEOR Pbi NEP 11 3 3 SONO coded dd ete MN NNNM NN ea ns dco NND ENFIN IR ena 11 3 3 1 EnvlronmentspecifiCallOliS ussesscexpetusindaxiadaxesUe PnsbbdadsE UU REL SERERE Kk PRr e Ux Dupa UU msbE lint des 12 3 3 2 Authentication and authorization ccccccceeccccseeeeeeeeeeeseeeeeseeeeeseeeeeeseeeeeseneeeeas 12 33 DENET VAAD Eme 12 i re dolo 4 Us rman al ssis E EAA EE 13 4 1 ifle POCO CNG EN EE TEE E E 13 4 2 Dala transmission TRE E EET DES 14 4 3 M bil device application Pc 15 ELM MERO CM Ele elei ETE EET 15 Lor Ole Ne DOIG ON EET 16 43 9 ODM ONS NR 17 SUME LU E 21 4 3 5 Options Server Configuration cccccceeccccesseeeeeeeeeeeeesseeeeeeseeeeeeesseeeeeeseeeeeeeeas 21 ASO BA ERR eS 22 T HE 07 0 t 22 AL WOO CMT 22 Qu PANCOTA sd Mad MM 23 Secldono JestHeDOL nens er ree ER EePEAR a a a RE SETS REESE raana aai 26 5 1 NOT AU OMA pe M 26
34. en a Windows Explorer On the left side it appears the personal computer s browser When selecting on the left side the Nokia Phone Browser directory on the right side of the explorer it appears the mobile phone s browser See Figure 6 Doc name MINAmL WP7 D7 7v2 Date 13 11 2009 ID D7 7v2 Security Confidential Revision Final Page 10 60 Contract IST 034690 ELE m Deliverable report WPO7 D7 7 v2 E d wo lt E m gt 2 P ie Ei Direcci n 4 Nokia Phone BrowserlNokia N95 8GB zm Carpetas x p AES 4 Ee Phone memory Memory Card E Contacts Messages B lt a gt hn C uu d m amp S m m cos ye Nokia N95 8GB a G a 3 m 5 a Nokia Phone Browser 4 Nokia N95 8GB See Phone memory C Memory Card E 9 Contacts E Messages bed Figure 6 Nokia Phone Browser a Step 3 Search the T7 2 MINAml application s sisx file placed in the personal computer and copy it into the Phone memory of the mobile phone a Step4 Browse into the Phone memory and select the Symbian application copied in the mobile device Make double click on it it ll ask for a confirmation say yes and the installation on the phone s memory will start See Figure 7 Mokia Application Installer Figure 7 Install confirmation 3 2 8 Update application If its necessary to update the application installed version just delete the application from the mobile device and follow again the steps specified ab
35. ering up the logger base One user 4 highlighted the importance of personal guidance before the test She told that it was easier to use the devices when one has seen the usage before Accordingly the importance of the precise written instructions was brought out in several answers It was mentioned that the stuck in the data transfer did not feel that bad since it was mentioned in the instructions that this may occur It was found necessary that also exceptional cases are described in the instructions I feel confident as know that this has happened before 4 All except one of the test users read the instructions One user 3 mentioned that he never reads instruction manuals So he did not read the instructions and carried out the data Doc name MINAmL WP7 D7 7v2 Date 13 11 2009 ID D7 7v2 Security Confidential Revision Final Page 36 60 e Contract IST 034690 Deliverable report WP07 D7 7 v2 uu transfer trusting on his memory He had to interrupt the data transfer because it stuck looping He did not know if this was due to his action or a technical problem Learnability of the system was seen high but the written instructions were seen very important role in the usage The routine of use was assumed to come after one night of use 1 B Transferring data from the logger to be analysed was easy E got the necessary feedback about the progressing of the data transfer Ol could influence enough th
36. eriods 1 h 32 min Number of DS periods 3 Number of unconstrained DS periods 14 Average DS period 26 2 min shortest DS period 19 0 min Longest DS period 33 0 min Average interval between DS periods lh 16 min Figure 43 The textual feedback of one of the pilot users sleep analysis No user was missing additional information It was mentioned that in the sleep analysis as such there is even too much data for an ordinary user Now the graphs look obscure 3 For ordinary users a simpler bar graph with data about time spent in bed duration of sleep accompanied with quality of sleep was seen adequate The users were ready to share the data with their doctor as well as with their family The data was compared to blood pressure data regarding privacy 4 But if there would have been something exceptional in the results would like it to remain more confidential 4 One user stated I wouldn t trust the data to a health nurse before a doctor has analysed the graphs 5 Thus it was highlighted that doctors knowledge is needed to interpret the graphs 5 3 6 4 Usefulness The users found the system generally useful When someone has sleeping problems the doctor can analyse if you do not sleep well or if you just assume so 1 Good to have data about sleep in black and white 1 Is useful in defining disorders but not useful for healthy people who feel that they sleep enough 4 The system was fo
37. g the user puts the Logger on the Logger Base which automatically performs data readout and recharges the logger batteries The Mobile Phone is used to read the data from the base via Bluetooth and sending the data to Medical Server via 3G connection The Medical Server executes automatic analysis provides user interface for the physician and enables messaging with the patient s mobile phone The user instructions applied in the test were substantially identical as those presented earlier in this document Logger Base Power supply e EEG Logger Figure 35 EEG Logger system components The logger in the photo is an updated version The logger that was used in the user evaluation is shown in Figure 36 Figure 36 Placing the EEG Logger for sleep recording 5 3 4 Evaluation procedure Doc name MINAmI WP7 D7 7v2 Date 13 11 2009 ID D7 7v2 Security Confidential Revision Final Page 30 60 Contract IST 034690 Ps Deliverable report WPO7 D7 7 v2 Xo Before the user evaluations two VTT researchers carried out pilot evaluation with the logger in July 2009 The aim was to pilot the user guide pilot the questionnaires and test the functionality of the system The pilot users used the logger overnight and downloaded and transferred the data in the morning They also filled in the questionnaires to test if the questions were feasible The user evaluation took place during August 2009 Before the actual test nights
38. g lighter towards morning Knowing this he is no more worried and can now fall asleep again without worrying Accordingly one user was familiar with theory of sleeping and he was interested in seeing his own sleep analysis He commented have read about sleep cycles The sleep analysis told me that there really are cycles in my sleep also 5 In general the participants saw the results reliable It was commented e g I have no reason to doubt the results 1 However some doubts occurred because the results and the users own experience of their sleep were not always similar For one user 2 it was surprising that the results showed that there was no deep sleep during the night I question the entropy deepness of my sleep Could it be that something is not right in the analysis in my case since felt that slept well He also commented Seeing from the sleep analysis that did not move much during the night gives me extra confirmation that indeed slept well Another user said My own impression was that slept restlessly However according to the analysis slept well 1 One user commented There were surprisingly many awakenings during the night The position indicated me when really was awake 4 Background information and experience on sleep related issued affected on trust I am familiar with entropy due to my work so have learned to have confidence on it 5 However some new features were found o
39. gger base measure data readout time Rass Fail 5 The readout time was 5 minutes Expected value less than 30 minutes Attach the logger on the forehead to start a recording Wait 10 minutes and detach the logger _ Wait 12 hours for the batteries to wear out Place the logger on the logger base to perform data transmission Check which indicator LEDs are lit in the logger base Oe V cheaGa ye Expected result Power charging Wait until the charging LED is turned off Verify Data transmission starts the 1 4 indicator LED is lit After the data transmission is completed connect the logger base to a computer via the USB interface and connect to the basa with a hyperterminal 14 Check the content of the logger memory FF A gt Expected result memory empty all fF 15 e Attach the logger on the forehead to start a recording 16 F Wait 10 minutes and detach the logger 17 j Place the logger on the logger base to start data transmission 18 ee i After 5 minutes of data transmission raise the logger 5 cm above the base for 10 seconds ee VEN Date 13 11 2009 Security Confidential Page 51 60 Doc name MINAmL WP7 D7 7v2 ID D7 7v2 Revision Final Contract IST 034690 P e Deliverable report WPO7 D7 7v2 xg oo MINAmI Frontal EEG Logger 1 56 GE Healthcare Verification Protocol 9 15 Verify using the hypertermin
40. he logger detects Doc name MINAmL WP7 D7 7v2 Date 13 11 2009 ID D7 7v2 Security Confidential Revision Final Page 7 60 Contract IST 034690 Ps Deliverable report WPO7 D7 7 v2 ico good data at the EEG leads and begins recording It will remain in this state until memory is full or low battery condition is detected or placed on the base station Transmitting This state is entered upon reception of a start data transmission command Logger remains in this state while the base issues commands Hibernate This state is entered upon detecting a battery low event Detection of inductive power will make the logger to enter the Charging state Power consumption is zero Table 1 T7 2 Logger state description When the EEG Logger is placed on Logger Base battery recharging takes place automatically In the end of the 8 h recharging period the Logger Base commands the EEG Logger to hibernate n order to take a hibernating logger back to stand by mode the operator shall place the EEG Logger on the Logger Base see Figure 12 for some 10 seconds Note After a prolonged storage time say weeks the EEG Logger shall be reloaded before overnight registration 3 2 Mobile device application The mobile device application associated to Health monitoring amp Homecare demonstrator runs on terminals with Symbian OS version S60 3 edition MINAmlI s mobile device applications are Symbian s 3 party external application
41. ical setup of the demonstrator GE Healthcare has developed a Sleep Quality Analysis system as one of the seven demonstrators of MINAml research project The system is intended for home monitoring of sleep disorders The tested device was composed of an EEG Logger a Logger Base for data readout and battery recharging and a mobile phone for data transmission The test device was used in home environment and no clinical decisions were made based on the test results Medical Server Data tramsmission amp storage User Interface Sleep Quality Analysis Data transmission User Interface Mobile phone EEG Logger amp Logger Base Data acquisition Capacitive data Tx Inductive recharging Physician s PC Web browser based connection to Medical Server Figure 34 A schematic diagram of the system under test In the basic form the user uses the EEG Logger for collecting EEG and acceleration signal overnight and sends the data for automatic analysis using Logger Base and mobile phone The system enables repeated measurements and provides feedback between recording sessions Doc name MINAmL WP7 D7 7v2 Date 13 11 2009 ID D7 7v2 Security Confidential Revision Final Page 29 60 e Contract IST 034690 i Deliverable report WPO07 D7 7 v2 iiis The user initiates data logging in the evening by attaching the Logger on his her forehead using adhesive electrodes For data readout from the logger memory in the mornin
42. ime 05 Aug 2009 00 48 01 24 02 00 02 36 03 12 03 48 04 24 05 00 05 36 06 12 06 48 07 24 08 00 08 36 Time s Figure 42 The sleep analysis graphs of one of the pilot users The upper graph shows sleep levels Awake REM Rapid Eye Movement LS light sleep DS deep sleep The middle graph is entropy The lowest graph shows the sleeping position Prone on the stomach Supine on the back RightS on the right side LeftS2on the left side Pilot2 UserEval 05 08 09 23 00 00 Time in bed TIB 8 h 20 min Sleep latency to first 60 seconds of sleep SOL 0h 10 min Wake time during sleep period WASO 0 h 37 min Total sleep time TST 7 h 33 min Sleep efficiency referred to time in bed SEI 91 Time in REM 0 h 33 min 7 Time in light sleep 5 h 35 min 74 Time in deep sleep 1 h 26 min 19 Number of sleep stage transitions 310 Number of sleep stage transitions per hour of sleep 39 0 Number of sleep stage transitions from DS to W 10 REM latency from sleep onset 4 h 34 min DS latency from sleep onset to DS 0 h 14 min Number of REM periods 3 Doc name MINAmI WP7 D7 7v2 Date 13 11 2009 ID D7 7v2 Revision Final Security Confidential Page 39 60 e Contract IST 034690 297 Deliverable report WP07 D7 7 v2 MINAm e Number of unconstrained REM periods 5 Average REM period 10 8 min Shortest REM period 4 5 min Longest REM period 18 0 min Average interval between REM p
43. ive you an overview of what your Nokia device can do in tandem with your PC http nds1 nokia com tutorials support global phones pc_suite english index html Doc name MINAmL WP7 D7 7v2 Date 13 11 2009 ID D7 7v2 Security Confidential Revision Final Page 8 60 Contract IST 034690 A e Deliverable report WPO7 D7 7 v2 X Ll T e Option 2 Windows Explorer s Nokia Phone Browser option 3 2 1 Option 1 Nokia PC Suite s install applications a Step 1 Plug the mobile device in the USB port of the personal computer In a few seconds a menu is visible in the mobile device then select that it s going to be used the PC ouite See Figure 2 x 11 17 Offline E Tu28 04 2009 0 am i al act a zy Search Internet and Mv content Select mode Data transfer Image print Media player Figure 2 Mobile phone s select mode a Step2 Open the Nokia PC Suite installed in the personal computer Then select the option Install applications See Figure 3 Nokia PC Suite File Web Settings Help ae Nokia N95 amp a e 3 dd a Q Y 5 s o Install applications ey Figure 3 Nokia PC Suite main window a Step 3 The Application Installer is shown on the left side of the window it appears the personal computer s browser and on the right side it appears the mobile phone s browser On the left side search and select the T7 2 MINAmI application s sisx file and on the right side select Pho
44. mi lt role ralename user gt zuser Usernames admin passwords admin roles manager gt lt user username romcat password tomcat roles administrator lt User username minami password minami roless minami lt User usernames userl passwords userl roles user gt lt tomcat users gt Figure 8 Tomcat users The T7 2 Health monitoring amp Homecare demonstrator Web Server application is configure to authenticate and authorize the role minami so minami it s the only user to have access to the 17 2 Web application 3 3 3 Server availability It must be performed the following test to ensure the server is working e Type in any PC s Web browser connected to Internet the following URL https minami fp6 tid es DemostratorT 72 data e It s atest server a certificate error is expected so pass around if possible e hen a pop up window will ask for a login password If its typed a wrong login password the pop up window will open again until it s typed the correct one e If the Web server is started up and the login password is correct the server must respond with a blank page See Figure 9 Doc name MINAmL WP7 D7 7v2 Date 13 11 2009 ID D7 7v2 Security Confidential Revision Final Page 12 60 e Contract IST 034690 i Deliverable report WPO7 D7 7 v2 x me Mozilla Firefox gt Gt 22 https fminamiz 8443 Demonstratarz data minamiz 8443 Gy
45. monstratorT 72 Login action This will open a secured connexion to the web interface Figure 28 The interface requires login and password Doc name MINAmL WP7 D7 7v2 Date 13 11 2009 ID D7 7v2 Security Confidential Revision Final Page 22 60 e Contract IST 034690 i Deliverable report WP07 D7 7 v2 MINA Micro Nano integrated platform for transverse Ambient Intelligence applications Medical Server Access Figure 28 Login action If login and password are right the user can access to registered patient information The options are select a patient to get further information register a new patient or update data Figure 29 Micro Nano integroted plotform for transverse Ambient Intelligence applications Health monitoring amp Homecare demonstrator Dr Howards Sylvia Patients filter z Mobile an AO O OO Ta TH N Search Patients associated Lonia Mobile g Number luser2 Carile Megan Doyle Johan enm luseri Silcox Sean E d Figure 29 Registered patient information 4 4 2 Patient data The user can update any personal data related to registered patients Figure 30 Doc name MINAmL WP7 D7 7v2 Date 13 11 2009 ID D7 7v2 Security Confidential Revision Final Page 23 60 Contract IST 034690 E o Deliverable report WP07 D7 7 v2 n Micro Nano integrated platform for transverse Ambient Intelligence applications irna nalth Falati aa maY P sta al gt
46. n validation resutls of the sleep scoring algorithm are presented This deliverable is structured as follows Section 2 Introduction brief introduction to the whole document Section 3 Installation Guide contains the steps needed to install the different components regarding the demonstrator Section 4 User Manual includes the instructions for the user about how to use the different demonstrator components Section 5 Test Report contains the different test cases that have been made to check demonstrator compliance and User Evaluation Doc name MINAmL WP7 D7 7v2 Date 13 11 2009 ID D7 7v2 Security Confidential Revision Final Page 3 60 o MINAmI e c md Contract IST 034690 Deliverable report WPO7 D7 7 v2 Acronym jSignification 1 101 JDK Java Development Kit Doc name MINAmI WP7 D7 7v2 Date 13 11 2009 ID D7 7v2 Security Confidential Revision Final Page 4 60 Contract IST 034690 dE LE Deliverable report WPO7 D7 7 v2 ai on Section 1 Executive SUMMANY acieatsecoeexec cud asc co ep dus med V oed ddr Deu oiis essen terscdesiteseneiaes 3 1 1 Description of the deliverable content and purpose 3 Section 2 INITODUCHON 6 Section 3 Installation guide sisscsivicctisirseredispieinvserceerenisterisaiiecisividetesininelestinesieiveievesiis 7 3 1 EEG Logger and Logger Base eere e
47. n of the complete demonstrator system Doc name MINAmL WP7 D7 7v2 Date 13 11 2009 ID D7 7v2 Security Confidential Revision Final Page 6 60 Contract IST 034690 Ps Deliverable report WPO7 D7 7 v2 T Section 3 Installation guide This section includes instructions for installing and configuring the EEG Logger Logger base Mobile application and the Medical server 3 1 EEG Logger and Logger Base The EEG Logger and the Logger Base include fixed firmware hence no configuration as such is needed The main configuration or maintenance activity for the physician or healthcare provider is to take care of the EEG Logger batteries The state diagram is shown in Figure 1 and a more detailed description of the states can be found in Table 1 inductive power stm Data logger states no inductive power Charging inductive power Hybemate command Initial inductive power inductive power EEG Lead on Memory full OG Adguirir Low Battery Low Battery Figure 1 State diagram of EEG Logger Standby The main idle mode when not operating In this state the data logger polls for EEG Lead On event every 10 seconds by analyzing valid data at the differential amplifier output Charging This state is entered when the logger detects that power source is inductive In this state the battery is recharging and the logger accepts commands from the Logger base by Capacitive coupling This state is entered when t
48. ne memory in order to install the Symbian application Doc name MINAmL WP7 D7 7v2 Date 13 11 2009 ID D7 7v2 Security Confidential Revision Final Page 9 60 e Contract IST 034690 ES Deliverable report WPO07 D7 7 v2 Jii there With the corresponding sisx file selected click on the install arrow in order to start the installation on the phone s memory See Figure 4 fH Nokia Application Installer Connected to Nokia N95 BGB File My Computer My Phone Help My Computer My Phone QQAAaLORE qa jo sis f Phone memory Name Application Name Size Type i The contents of the currently selected phone model cannot be DENM Symbian shown by this application s Symbian 4 Symbian 4 Symbian Symbian 4 Symbian 4 Symbian Application information Available space on Phone memory 61752 KB 9 Symbian Application Click here to install the application into the phone NOKIA Figure 4 Nokia Application Installer 3 2 2 Option 2 Windows Explorer s Nokia Phone Browser a Step 1 Plug the mobile device in the USB port of the personal computer In a few seconds a menu is visible in the mobile device then select that it s going to be used the PC ouite See Figure 5 x 1117 Offline Tu 28 04 2009 am j Search Internet and Mv content Select mode Data transfer Image print Media player Figure 5 Mobile phone s select mode oe a y amp Pn xp eg a Step2 Op
49. on and professional version The home version could include features that support self control and give immediate feedback after the night One user 3 suggested that the professional version could include supporting measures such as breath analyser to diagnose apnoea oxygen saturation A combination of SpO2 apnoea meter and sleep logger would be quite cool for a sleep laboratory In the final workshop it was discussed that heart rate measurements are also important part of the data and the existing logger could quite easily be modified so that it would also measure heart rate In the final workshop it was concluded that the consumer version could be based on PC or mobile phone software that could download the sleep data and send it to be analysed The results could then be monitored and stored on the personal computer or mobile phone It was emphasized that the analysis should be an external service software alone without a human interpreter is not a good solution The professional system should be an all in one solution a logger base with embedded data connections In that way the device could be loaned to the patients as a plug and measure unit In the final workshop the clinicians emphasized that the logger should be easy to keep clean It also turned out that the time scale in the analysis graph was an estimate the final logger should include a clock with exact time Doc name MINAmL WP7 D7 7v2 Date 13 11 2009 ID D7 7v2 Security C
50. on the top blinks once in a second to show that measurement is going on It may take up to 10 15 minutes for the measurement to start depending how long it takes for the electrode contact to stabilize Go to bed and sleep normally In the morning detach the EEG Logger The measurement will go on and the LED keeps blinking until 10 hours from the start of the recording even if the EEG Logger is detached Detach and dispose the electrodes Clean the adhesive residue from your forehead using a disposable fingernail polish remover pad Figure 11 Placing the EEG Logger for sleep recording Note The skin under the electrodes may be slightly reddish This will disappear in few hours 4 2 Data transmission Environmental needs Internet connection through GRPS or Wi Fi access point Mobile device with signed MINAml T7 2 application installed Procedure O Power up the Logger Base Power LED is illuminated continuously Charging LED blinks once in ten seconds Place the EEG Logger on the Logger Base precisely as in shown in Figure 12 lt does not matter if the LED in the EEG Logger is blinking or not Data readout from EEG Logger to Logger Base starts automatically and takes about 15 20 minutes Doc name MINAmL WP7 D7 7v2 Date 13 11 2009 ID D7 7v2 Security Confidential Revision Final Page 14 60 Contract IST 034690 a e Deliverable report WPO7 D7 7 v2 X T gm Figure 12
51. onfidential Revision Final Page 42 60 o MINAmi e c md Contract IST 034690 Deliverable report WPO7 D7 7 v2 5 3 7 Conclusions The main conclusion from the evaluation is that the concept is working all five test users as well as the two pilot users could wear the logger overnight and it did not disturb their sleep much Even it the users did not have specific sleep problems the information of sleep data was felt interesting For consumer use even less information could be enough and easier to understand for the users The simplified sleep analysis with just two levels of sleep deep and light seems to work However with the traditional classification with 4 sleep levels perhaps the users whose analysis included very little or not at all deep sleep might have got more thorough information In the current system the limit for deep and light sleep may require checking Both the test users and the GE representatives in the final workshop saw two parallel development paths a consumer device and a professional device For a consumer product the analysis could and should be simpler and include immediate feedback after the night Professional version might require more supporting measurements Consumer device could include the logger and a connector to read the data to PC or mobile phone The professional version could include the logger and a logger base with integrated mobile phone or other data connection facility In the con
52. onfiguration Help Back Figure 26 Options menu in Server Configuration window 4 3 5 1 Change When selecting this action the user can change the value of the selected item Doc name MINAmL WP7 D7 7v2 Date 13 11 2009 ID D7 7v2 Security Confidential Revision Final Page 21 60 KEE MINAmI e Contract IST 034690 Deliverable report WPO7 D7 7 v2 The URL that must be typed to configure the server is https minami fp6 tid es DemostratorT72 data The login password are case sensitive user1 user1 4 3 5 2 Test Configuration This server configuration must be tested in order to authenticate and authorize the user selecting this option The server response is displayed on screen as follows x TS MINAmIT 2 f Configure server 0 URL https minamti fpo ti user1 e MINAmI T7 2 TEST ACK Figure 27 Server response to Test Configuration 4 3 5 3 Help Not implemented 4 3 5 4 Back Selecting this option the application comes back to main view See Figure 16 4 3 6 Back Clicking the soft key labelled Back main view is activated 4 4 Server The Web server is hosted in a TID s test server and stores the MINAml T7 2 Web application The Web application receives in chunks the file stored in the mobile phone memory and stores it in the structure of the server 4 4 1 Login To access to the website the user can navigate to the following URL https minami fp6 tid es De
53. our of the logger can be selected to create a casual feeling 4 The guide book should also emphasize that the device will not harm your brain One user 3 had problems in positioning the logger on the forehead The right position should be indicated by an up marker not left right marker with which the mirror can confuse the user Some users were missing better feedback on the measurement starting and the logger being ready for data download In the guidance it should be explained that the measurement does Doc name MINAmL WP7 D7 7v2 Date 13 11 2009 ID D7 7v2 Security Confidential Revision Final Page 41 60 Contract IST 034690 Ps Deliverable report WPO7 D7 7 v2 Xo not start right away but the user has to wait for the measurement to start even 10 minutes Similarly it should be emphasised that data download can be started despite the blinking led on the logger These issues were corrected in the user guide after the two first test users In the final workshop it was discussed whether the led will be needed at all The device should be reliable enough so that the user can just put it on his her forehead and rely that the measuring starts However the usability experts from VI T emphasised that users would like to have feedback on ongoing measurements It was discussed also that it is important to get feedback that the logger battery is fully charged for the measurement One user 2 wondered why one of the electrodes was on
54. ove 3 2 4 Installation test Once the application is installed it s now available in the Applications folder on the mobile device s menu Click on MINAmlI T7 2 icon and if the first page of the application appears it means that the application was installed successfully 3 3 Server The installation of the Web server is out of project s scope in phase II It has been used a TID test environment and server Doc name MINAmL WP7 D7 7v2 Date 13 11 2009 ID D7 7v2 Security Confidential Revision Final Page 11 60 Contract IST 034690 dim Deliverable report WPO7 D7 7 v2 x jit 3 3 1 Environment specifications The host name is minami2 and it has the following characteristics Microsoft Windows XP Service Pack 2 Java 2 SE Development Kit JDK 6 Update 2 Web Server Apache Tomcat 6 0 14 Secure Protocol SSL Logging utility Apache log4j library T7 2 Web application deployed in the server 3 3 2 Authentication and authorization The mechanism used to authenticate and authorize users in the server is the lapache tomcat 6 0 14 conf itomcat users xml resource offers by the Web Server Apache Tomcat The user s roles are specified in that file in the following way See Figure 8 tomcat users xml Bloc de notas Fek Archivo Edici n Formato Ver Ayuda lt xml versdon 1 0 encodings utf 8 lt Tomcat users gt lt role rolename manager gt lt pole rolenames administrator gt lt pole ralename mina
55. pired certificate requires manual confirmation EEG MOB 005 Notification reception ox Medical Server and Sleep Analyzer Requirement TAG Description Status Comments ecounson wmenwememe o EEGMDS O02 _ Medcalsenersupose ox tGMDSom Patentrottetons ox tGWDSow Pwsanmetwe oxo emsoss Sevemcopodon OK FEEGMDS 005 Patentnotiatons OK tGWDSoy Userideniicaton OK tFGMDSo para proteston eseon x eeano Awyssapi mme OK ooo Test cases EEG MOB 004 Logger data transmission The test cases to be tested appear in the document in D7 14 Test amp Validation plan for the final set of demonstrators Testcase TAG Description Status Comments TC T72 01 Nightly logger recording OK fF TC T72 02 Logger reading amp recharging K To 172_03 Observational test ofthe system OK C204 Configure mobile application OK remos _ Transterdatatosener OK remos Vmmkedwa x 0 Doc name MINAmL WP7 D7 7v2 Date 13 11 2009 ID D7 7v2 Security Confidential Revision Final Page 27 60 Contract IST 034690 Paes Deliverable report WPO7 D7 7 v2 ed notification 5 2 Algorithm performance The developed EEG analysis algorithms and their validation have been described in a public document Automatic Sleep Scoring from Frontal Electroencephalogram Sipponen Sini Master s thesis Helsinki university of T
56. r controls OK fo EEG LOG 002 Disinfection between users ok EEG LOG 003 Sterile skin contact OK Batteries recharged automatically when necessary EEG LOG 005 One recording session shall last overnight Dimensions 40x90 l e mm required EEG LOG 006 M logger shall not disturb patient s 40x60 P Weight 60 g required 50g MM Readout 15 min EEG LOG 007 Data downloading time 30 min required Download time as EEG LOG 008 The data shall be time stamped Sr The non disposable logger shall be 0 fo economical to use Logger Base Requirement TAG Description Status Comments EEG RDR 001 No user operable controls in the data OK fo reader EEG RDR 002 Unambiguous pairing of reader and tag OK fe EEG LOG 004 Data readout without battery power EEG RDR 003 Data download shall initiate automatically OK EEG RDR 004 Data download shall terminate OK automatically Doc name MINAmL WP7 D7 7v2 Date 13 11 2009 ID D7 7v2 Security Confidential Revision Final Page 26 60 e Contract IST 034690 xdi Deliverable report WP07 D7 7 v2 iNHm e EEG CHR 001 CHR EEG CHR 001 Exremesimplictyofuse Exremesimplictyofuse of use EEG CHR 002 No user operable controls in the battery H charger Mobile application Requirement TAG Description Status Comments EEG MOB 001 Data transmission vehicle EEG MOB 002 User interface 0000 interface E start Message from ex
57. report WPO7 D7 7 v2 Xo would be the same as normally that is home 5 One user 4 saw the sleep logger as a device which could be loaned out from the health centre The participants were asked would if they would use the sleep logger if it would be available and if they would have the need to measure their sleep quality Four of five users would be ready to use the device One participant 3 said that he doesn t use a sphygmomanometer either so maybe he would not be interested in using the sleep logger The users were not asked about pricing but two users presented their estimates of an acceptable price for a device for home use as 100 150 5 and 200 300 8 Based on their experiences all the test users would recommend the sleep logger to their friends of relatives The logger would be recommended because it is easy 5 it causes no harm to the user and also because collecting the data does not hurt 4 However it was doubted if elderly people would cope with the data transfer 2 The sleep analysis was seen useful e g for people who often wake up during small hours The analysis would tell them that awakenings are normal during that time The participant who pointed this out 3 benefited from the analysis and he also thought that some people who might e g have sleep medication in vain would benefit from the sleep analysis The same user 3 however also pointed out People easily generate diseases for themselves
58. rs and analysing the results In addition VIT researchers acted as pilot users and carried out expert usability evaluation of the prototype 5 3 2 Participants The logger was evaluated with five voluntary users recruited from GE staff however not people involved in sleep quality research The users had personal interest towards the study Four of them had technical background Two of the five test users were women and three were men The participants ages varied between 33 and 57 years According to their own descriptions four of them usually sleep well and one never sleeps well Four of the five participants are interested in trying out novel technology whereas one is interested in technology only if the technology is of help The test users are presented in the Table 2 Doc name MINAmL WP7 D7 7v2 Date 13 11 2009 ID D7 7v2 Security Confidential Revision Final Page 28 60 e Contract IST 034690 xdi Deliverable report WPO7 D7 7 v2 Ced Participant Gender Ageyrs Sleeping habits Attitude towards technology Female Usually sleeps well Is interested in trying out novel technology e ox qme tpa technology of help ot pe Usually sleeps well Is interested in trying out novel technology Female 36 Usually sleeps well Is interested in trying out novel technology Male 33 Never sleeps well Is interested in trying out novel technology Table 2 Background information of the test users 5 3 3 Techn
59. s sis files that must be signed sisx files so the device can confirm its authenticity and it came from the intended developer and is not a virus of some sort Environmental needs e Desktop computer or laptop with USB port or Bluetooth connection e MINAml enabled mobile device Symbian OS version S60 3 edition e MINAml Health monitoring amp Homecare demonstrator 17 2 hereafter mobile application signed There are two options for installing the MINAml s mobile device application For both of them Nokia PC Suite software must be installed and configured e Option 1 Nokia PC Suite s install applications option Nokia provides free digital certificates to sign any application for each terminal To generate those certificates is needed the IMEI number of each device The IMEI number is usually printed on the compliance plate under the battery or in the mobile device s box It can also be get in most mobile devices typing the code 06 so it appears directly in the display When the product is finished the certificate must be bought to Nokia to sign the application with it so it can be distributed for every terminal In order to install the application the provider must supply a valid signed application for the mobile device that is going to be used Nokia PC Suite is a free software package for connecting your Nokia device to a compatible PC The following address offers a complete tutorial with animated demonstrations that can g
60. sumer version it would be important to give the results to the user right away or at least after a short analysis phase In the professional version the quick feedback to the user is not required because the results go to a professional to be analysed Doc name MINAmL WP7 D7 7v2 Date 13 11 2009 ID D7 7v2 Security Confidential Revision Final Page 43 60 Contract IST 034690 id e Deliverable report WPO7 D7 7v2 Rr acis Annex MINAmI Frontal EEG Logger Verification Protocol WEN GE Healthcare MINAml Frontal EEG Logger Verification Protocol Author Petteri Lapinlampi CONFIDENTIAL amp PRIVILEGED This document contains confidential and privileged trade secrets and other information of General Electric Company and as such may not be disclosed to others not employed by General Electric Company All rights reserved Date 13 11 2009 Security Confidential Page 44 60 Doc name MINAmL WP7 D7 7v2 ID D7 7v2 Revision Final So Contract IST 034690 MINAmI e Deliverable report WP07 D7 7v2 M CM MINAm Frontal EEG Logger Nc GE Healthcare Verification Protocol a 2 15 Table of contents 2 Change history s 1TrTestinformation 4 1 1 Test type 5 1 2 Test Equipment l amp 1 2 1 Test Device write also seriallD D numbers 7 1 2 2 Test Software nidi ih 8 1 3 Test Personnel i es a 2 Test Summary 0 2 1 Results
61. t When clicking Select option different actions take place according to the selected item e Send data In case of Send data the application verify if data from data logger is stored in mobile In other case it establishes a Bluetooth connection with the configured data logger If any data logger is configured it displays an information note to the user Doc name MINAmL WP7 D7 7v2 ID D7 7v2 Revision Final Date 13 11 2009 Security Confidential Page 17 60 e Contract IST 034690 T ow Deliverable report WP07 D7 7 v2 T m As soon as the Bluetooth connection is established the application receives data from data logger See Figure 18 Jm Configured Send data Sms Lis view messages Receiving Data 9 PEPR PF LP LP LP LP a LP Pg Figure 18 Receiving data from data logger When data reception ends the transfer data process starts See Figure 19 The server settings have to be configured and the access point selected See 4 3 5 x o2 MINAmITT 2 Es Configured A Send data en Un EE View messages Sending Data to 9 Doctor SMA MAMMA BABB A Figure 19 Sending data to server Action result is displayed on screen In case data logger was stored in mobile when clicking the Select option the user decides if he wants to send this stored data to server or remove old data and establishes a connection with data logger and receive new data See Fig
62. tal EEG Logger Qj GE Healthcare verification Protocol CE 7 15 5 lest Cases a Special Instructions az NONE Test Case ID EEGLO G T72 01 Description Nightly logger recording Applicable for EEG data logger Requirements EEG LOG 001 EEG LOG 005 Initial Conditions Equipment is set up as per Equipment Setup section Task amp Expected Result Attach the logger and the electrodes on the forehead of a test subject and wait 20 seconds Verify The led on the logger is blinking once per second Ll 3 Detacht the logger and measure the time until the logger LED stops blinking O h Fam Expected result at least 10 h s Comments 1 the sfout Ens C e T EE gr Mee V t S f sa Tester Date oy 100 Doc name MINAml WP7 D7 7v2 Date 13 11 2009 ID D7 7v2 Security Confidential Revision Final Page 50 60 ety Contract IST 034690 E oi Deliverable report WP07 D7 7v2 o T unm MIMAm Frontal EEG Logger s 26 GE Healthcare Verification Protocol 8 15 100 Test Case ID EEGLOG T72 02 Description Logger reading and recharging i Applicable for EEG data logger Requirements EEG LOG 004 EEG LOG 007 EEG LOG 008 EEG RDR 001 EEG RDR 002 EEG RDR 003 EEG RDR 004 Initial Conditions Test case EEGLOG T72 Olcompleted Step Full Regr Task amp Expected Result E C el E D 4 Place the logger on the lo
63. und useful if the analysis helps to find ways to make one s sleep better 2 The system was assumed to be targeted for people who have sleeping problems 2 One user also commented People are interested in themselves and about their health This logger responds this need and can be compared to sphygmomanometer in this sense 3 The development direction of the sleep logger was found twofold Firstly there could be a device for home use in the market People who want to measure their sleep or e g the relation of the quality of their bed related to quality of sleep would have the possibility to receive a simple sleep analysis It was ideated that already in the morning a small display attached to the logger would show a simple graph of the previous nights sleep 2 According to the direct information of ones sleep people could pay attention to their sleeping habits as well as to their lifestyle Secondly the device could be useful in clinical sleep research with people who have serious sleeping problems It would be much more comfortable to sleep at home than in a sleep laboratory 1 5 Also the costs when measuring sleep at home would be smaller compared to nights spent in a laboratory 5 In addition the reliability of the data was brought out since the environment during the research Doc name MINAmL WP7 D7 7v2 Date 13 11 2009 ID D7 7v2 Security Confidential Revision Final Page 40 60 Contract IST 034690 Ps Deliverable
64. ure 20 and Figure 21 Doc name MINAmI WP7 D7 7v2 Date 13 11 2009 ID D7 7v2 Security Confidential Revision Final Page 18 60 Contract IST 034690 2 Deliverable report WP07 D7 7 v2 x TS MINAmIT72 Configured i 1 Send data Sms View messages Data of Logger Base D found send data to doctor Figure 20 Data stored in mobile phone x TA MINAmI T7 2 l E peee Configured ih Send data sms aa View messages Do you prefer to D remove the data Mi Figure 21 Confirmation to remove data e View message This screen shows a list of historical messages that the server the physician sends to the patient See Figure 22 The left soft key Options presents a menu to select the marked message and read its content or Back to main view Figure 22 Sms view Doc name MINAmL WP7 D7 7v2 ID D7 7v2 Date 13 11 2009 Security Confidential Revision Final Page 19 60 Contract IST 034690 M e Deliverable report WPO7 D7 7 v2 xg 4 3 3 2 Configure If the user selects this option a sub menu is displayed See Figure 23 The options here correspond to Logger and Server x TS MINAmI T7 2 r Not Configured FII xd Send data Sms View messages Select Configure Help Server Exit Figure 23 Configure options e Logger When selecting this option a new procedure for searching data loggers starts See Figure 15 e Server
65. ut The appearance of REM in different parts of the night made me a little confused However know that making the analysis more accurate would need more from the device technically 5 Accordingly There were a lot of interruptions in my sleep analysis think that it is because sleep on my stomach and the contact with the electrodes may get disturbed 3 Sleeping position and entropy were seen the most interesting results The participants found as the most interesting result seeing some new and even surprising information about their sleep I trust the information about how deep my sleep was However found it strange that there were so many awakenings during the night 4 It is interesting to see the sleeping position thought sleep supine but the analysis tells me that slept also on both right and left sides 411 The analysis told that my sleep was better than myself thought 5 In the sleep analysis many users had interest especially in percentage and hourly presentation of their sleep It was also found useful to see own sleep analysis compared with an ideal analysis result a school book version Doc name MINAmL WP7 D7 7v2 Date 13 11 2009 ID D7 7v2 Security Confidential Revision Final Page 38 60 Contract IST 034690 Deliverable report WPO7 D7 7 v2 LS p Automatic scoring SISi Prone Supine RightS LeftS Unknown 23 00 e MINRmlI e Sleep case Pilot2 UserEval t
66. v2 Revision Final 23 ao 1000 Cycles up ta 6 years 20 C up to 3 years 45 C Subject to change without prior notice Date of lassus 04 05 18 Date 13 11 2009 Security Confidential Page 59 60 e Contract IST 034690 xi h Deliverable report WPO7 D7 7v2 XR SILICONES Evaluation of Biocompatibility for WACKER ELASTOSIL M 4641 A B Toxicological tests on WACKER ELASTOSIL M 4641 A B have not been carried out However irritation sensitization and cytotoxicity tests according to the ISO 10993 standard with different two component addition curing silicones of similar base materials have been performed and did not show any adverse effects Based on this analogy and the toxicological properties of the ingredients it is expected that ELASTOSIL M 4641 A B will not cause skin irritation sensitization or cytotoxic effects Provided that the material is appropriately cured postcured ELASTOSIL M 4641 A B is not expected to cause any adverse effects in humans at direct contact with skin Wackher Chemia AG E yv Burghausen May 09 2008 Dr C Burger GB 3 IMS Manager Product Stewardship 1 biocorgeatibilly M An 1 dac Doc name MINAm WP7 D7 7v2 Date 13 11 2009 ID D7 7v2 Revision Final Security Confidential Page 60 60

Download Pdf Manuals

Related Search

MINAmI_WP7_D77_GE_TID_PU_NEW

Contents

Download Pdf Manuals

Related Search

Related Contents