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1. 111 4 5 4 DOWNLOADING THE TEST 112 4 6 REVIEWING THE TESTS 115 4 6 1 REVIEWING A TEST 115 4 6 2 FULL SCREEN MODE M IG 115 4 6 3 DOUBLE WAVEFORM WINDOW nM 115 4 6 4 PLAYING THE TEST re 116 4 6 5 SCROLLING THROUGH THE TEST 116 4 6 6 ADJUSTING TIME ON THE 6 116 534 740 MU2 REV 1 05 sjuojuo JO o qe L Table of Contents BitmedLab User s Manual SER NOTES vas RI DONE NR 121 4 6 8 ADJUSTING WAVEFORM RANGES 123 4 6 9 ADJUSTING WAVEFORM SIZES M 124 4 6 10 MODIFYING THE VIEWING ORDER OF THE WAVEFORM QiseisbIEPvIRRPNODONNDVIR ERN KR 125 4 6 11 NAMING THE WAVEFORMS 126 4 6 12 HIDING OR SHOWING SEPARATION BETWEEN WAVEFORMS RERUM SENE d RM M iiis 127 4 6 13 ADDING AND DELETING WAVEFORMS 127 4 6 14 DELETING 8 129 4 6 15 DELETING ALL THE 8 129 4 6 16 SETTING UP THE SENSOR ASSOCIATED TO EACH INPUT CHANEL ei or rr ee 129
2. 5ampling nates oo Low pede ftar 38 NE Colores personalizadas range Howe 2323 bk Display range Definir calorez percanalzados gt gt 75 Close Channel properties by clicking on Close 4 6 20 DISPLAYING THE WAVEFORM VALUES If you wish you can display the real values of the signals on the waveform at regular intervals 100 0 86 7 73 3 60 0 100 0 94 93 93 94 94 94 94 94 83 92 92 93 93 93 Ch10 Sa02 80 0 60 0 50 50 50 49 49 50 50 52 54 54 55 54 53 52 400 Pulse Click the right button of the channel over the waveform to be changed and select the Channel properties option in the contextual menu Enable the Show values on channel option 534 740 MU2 REV 1 05 BitmedLab User s Manual Wavafarm settings Input channel Sale Comments NN meted Sampling rale 10Hz Dizplav signal valuas over the via efam Input range volue 100 vue 0 Display range 100 Min welue 5 Click on Close to close Channel properties 4 6 21 NUMERICAL VALUES CURSOR The numerical value cursor is a vertical line that the user can scroll freely across the screen The status bar shows the value of the signal in the position and the channel that the cursor is on To HHHH Cursor 97 0 Go to the Analy
3. 468 452 0 4 4 9 4 03yV2 Hz 3 87 uV2Hz 3 71pV2 Hz 3 55yVHz 3 39yV2 Hz 3 230 V2 Hz 3 06 uVzHz 2 90pV2 Hz 274yVHz 258 2 42 2 26 2 2 2 10pV2 Hz 177 1 61 Vz Hz 1 45 2 2 1 29 6 Abd 1 13 2 2 0 97 uV2Hz 0 81yV Hz D 65pV2 Hz 0 48 D 32yV2 Hz 0 46 0 00 00 00 005 OOh39m09s O1h18m18s 01h57 m27s O2h36m36s O3h15m45s O3h54m54s O4h34m03s O5h13m12s 05852 215 0631 305 Time Choose Graph power frequency time in the See menu or use the button in the toolbar The program will ask for the channels to display in the graph Channel selection for the power frequency time view Available channels Selected channels Channel 9 EMG Chin Channel 8 EEG C3 01 Channel 10 EOG EDG Derivation EEG Channels 17 18 C4 0 Channel 11 UARS Channel 12 Thoracic effort sensor Channel 13 Abdominal effort sensc Channel 14 Flow thermocouple Channel 15 Flow transducer Channel 16 Customized sensor Ca Channel 17 EEG C4 Channel 18 EEG 02 Channel 19 EOG EOG D Channel 20 EOG EOG I m lt lt a LS lt Select the channels to apply the FFT in the power frequency time view After the FFT has been calculated the power frequency time graph will appear If the user places the cursor over any point of the graph and right clicks he will obtain the power for the chan
4. enue A 8281 User s Manual Software BitmedLab BitmedLab User s Manual How do you want to search for driver software gt Search automatically for updated driver software Windows will search your computer and the Internet for the latest driver software for your device unless you ve disabled this feature in your device installation gt Browse my computer for driver software i Locate and install driver software manually Use the Browse option to find the USB Drivers folder in the BitmedLab software CD Click on Next Browse for driver software on your computer Search for driver software in this location DAUSB Drivers 2 6 2 0_100330 driver 7 Include subfolders gt Let me pick from a list of device drivers on my computer This list will show installed driver software compatible with the device and all driver software in the same category as the device Windows will show a message indicating that the manufacturer of the driver software could not be verified Click on Install this driver software anyway 534 740 MU2 REV 1 05 BitmedLab User s Manual Windows can t verify the publisher of this driver software Dont install this driver software You should check your manufacturer s website for updated driver software for your device Install this driver software anyway Only install driver software obtained from your manufacturer s website or i disc Unsigned soft
5. 27 3 182 0 91 0 00pV2 Hz 00 005 01805 155 0210 305 0315 455 0421 005 0526 155 In the Graph properties window select the range of frequencies you wish to view and click on Accept to apply the changes 6 2 4 SHOWING THE GROUPED FREQUENCIES BY FREQUENCY BANDS Open the Viewing options window from the Analysis menu gt Viewing options Enable Power frequency time Enable See frequency bands 534 740 MU2 e REV 1 05 qe enue A 8281 User s Manual Software BitmedLab BitmedLab User s Manual Configurations Montage Test Traces Power frequency time Power frequency map Video Visualization settings C Show frequency bands Click on Accept to close the window and apply the changes 6 2 5 PRINTING THE POWER FREQUENCY TIME VIEW Go to File Print Choose the printer printer properties printing interval and number of copies Click on Accept to start printing 534 740 MU2 REV 1 05 BitmedLab User s Manual 7 BRAIN MAPPING The optional brain mapping module transforms electroencephalographic signals into information about brain activity and displays the power in each frequency spatially The functions describe throughout this chapter are only available if you have purchased the brain mapping license 7 1 POWER FREQUENCY MAP The power frequency map is the graphic rep
6. Events inserted manually show the mark M while events detected by automatic analysis show the mark A Toggle between the three views by using the E key or from Viewing options Open the Viewing options window from the Analysis menu Viewing options Enable the Waveforms tab 534 740 MU2 REV 1 05 BitmedLab User s Manual Choose the option you wish to use in Event mark descriptions Click on Accept to close the window and apply the changes 4 6 29 PRINTING BitmedLab allows the user to print the stage being viewed on the screen a selection of several epochs consecutive or not or the complete test Printing the on screen epoch the entire epoch or a selection of epochs Browse to the epoch you wish to print and go to File gt Print Choose the printed items to include in the dialog For example a header with user data and or logo can be added These options are saved each time printing is done Print settings Print options C Logo C User data Patient data L Traces Test and trace settings C Sleep stages and events Print range Screen Full test Selected epochs Choose the printing range and click on Accept Direct printing The epoch on the screen can be printed directly by simply clicking on Direct printing M in the Standard toolbar The epoch will be printed with the last settings used to print from File gt Print Choosing epochs for future printi
7. ca 42 215 km Ea Channel E 1 33 C Bipolar 2 5302 34 Reference Pz n EEG DC DCI EEGA B Pos DC2 EEG EEGE Click on Accept to see that a new channel has been created as a result of referencing one inlet channel to another C3 Pz Creating a derivation by selecting its two electrodes This alternative method for creating derivations allows the user to create new derivations easily and quickly Open the Viewing options window from Analysis Viewing options Enable the Montage tab Choose the waveform window where you wish to create the new derivation Enable the Bipolar box in the Channel panel On the right part of the window click on the first electrode of the 534 740 MU2 REV 1 05 BitmedLab User s Manual derivation Configurations Montage Traces Power frequency time Power frequency map Video indon use mo ea o na ac O Pulso 33 v Bipolar D EEG 2 Sa02 34 O EEG 3 B DC DC1 O EEG 4 Pos DC2 o EEG 5 EEG o EEG 7 Reference Avg ref Set reference e Delete all Settings Edit average reference Now choose the second electrode of the derivation
8. Customizable keys Eventtypes User data b Health center company Address ZIP code City Telephone E mail To select a logo click on the button of the Logotype field and choose your logo image The image must be stored in a file with BMP format 3 1 4 ENTERING THE SLEEP amp GO DATE AND TIME Before starting tests with your Sleep amp Go system we recommend entering the date and time of the device This information is used when programming tests to be performed in holter mode in which the device starts monitoring the patient on a specific date at a specific time The device date and time option can only be entered from BitmedLab software in Sleep amp Go systems equipped with the Bluetooth communication module In all the other systems the date and time must be entered by using the graphics screen of the device Refer to the device manual Go to the Polygraph menu Enter date time If more than one Screen amp Go Sleep amp Go is available choose one A window appears with the date and time of the PC Modify the date and time if necessary When you are ready click on Enter to apply the changes to your Sleep amp Go 534 740 MU2 REV 1 05 21e 3jogs enue A 5 281 User s Manual Software BitmedLab BitmedLab User s Manual 3 1 5 DELETING STUDIES FROM THE SLEEP amp GO MEMORY CARD Each time you perform a test whether in holter or real time mode a fil
9. Stage 3 3 The associated keys can be changed by going to Tools gt Options gt Custom keys You can also check the hoykeys in Annex 3 of this manual 4 6 24 EVENT TYPES BitmedLab defines a series of event types that the user can mark in the tests For user convenience BitmedLab limit the available event types according to the group of event types that are enabled at a given moment There are three groups of event types simple intermediate and advanced each of which enables certain types of events as seen in detail in the table below Simple Intermediate Advanced Central apnea Snoring Limb movement Regular breathing Undetermined breathing event Movement arousal Tachycardia Q Select a group of event types depending on the type of test to be performed For example the simple type may be enough for a screening test while the advanced type may be the proper option 534 740 MU2 REV 1 05 21e 3Jogs enue A 5 281 User s Manual Software BitmedLab BitmedLab User s Manual for a cardiorespiratory polygraph Only one group of event types can be enabled at the same time in the program In other words if the simple group of event types is enabled and a test is opened with tachycardias marked the latter will simply not appear However if the group is changed to advanced
10. these parameters are grouped in an channel configuration Each channel configuration has a name assigned by the user so it is easy to recognize During the performance of the test check that the sensor connected to each channel corresponds to the selected channel configuration The configurations are stored in the device memory card and a maximum of ten is allowed at the same time The extension of the configuration files is CFG The SleepLab software module can generate manage and store as many configurations as necessary Your device also has a default channelevice configuration that is used when the test is started manually from the device itself This configuration is labeled as Internal in the device If you have a Sleep amp Go with a Bluetooth communication module the device default configuration can be set from the BitmedLab software If not this option will be disabled and must be done from the device itself refer to the User s Manual of the device by choosing from the configurations found in the memory card Any of these configurations can be set as Internal from the device itself 3 3 1 CREATING MODIFYING AND DELETING CONFIGURATIONS In the main menu go to Polygraph Configurations 534 740 MU2 REV 1 05 BitmedLab User s Manual Configurations Configuration ammen Airflow prezure E nable this channe thermocouple able thir
11. Cancel Help Inputs this button is only available in certain card models those with several inputs for video signals A dialog appears for the user to select the input that the video source is connected to Video capture device a list of the devices installed in the system capable of capturing video Select the video capture card Audio device properties this shows a new dialog where the user can select the input line from which to perform audio capture camera Input line Input etc These options will vary depending on the sound card model or the video capture card if the latter has an option for capturing audio Propiedades Propiedades del mezclador de entrada de audio Mezcla de entrada principals Mezcla de entrada de linea de clavija F Agudos 1 Agudos Graves Graves T Habilitar Volumen Habilitar Volumen L nea de clavija 7 Mono Camera Input Y 534 740 MU2 REV 1 05 21e 3Jogs enue A 5 28 User s Manual Software BitmedLab BitmedLab User s Manual Audio capture device a list of the devices installed in the system capable of capturing audio Choose the device that you wish to use in the tests Sampling several audio recording features can be chosen in this block Recording in stereo or mono 8 or 16 bit coding the higher the bit coding the better the sound will be but this will
12. Click on Next Time period to be analyzed Use the start end marks for the automatic analysis Ignore periods at the begining end of the test Ignore the first 0 minutes of the test ignore the last 0 of the test C Perform the analysis between two notes Start End Endofthe test The following window shows the progress of the analysis When the analysis has been completed click on Next Analysis progress Analyzing the test and detecting events Snores PLM Desaturations Apneas hipopneas 486 Tachycardias bradycardias Detecting desaturations Back Finish Cancel Lastly the wizard will show a summary of the events that have been detected 534 740 MU2 REV 1 05 qe enue A 8281 User s Manual Software BitmedLab BitmedLab User s Manual Analysis summary Summary of the test analysis The automatic analysis found the following events Apneas 1 Hipopneas 10 1 obstructive apneass 0 central apneas 0 mixed apneas Desaturations 11 Limb movements 10 Tachycardias 0 Bradycardias 0 3 9 24 MODIFYING THE OPTIONS FOR AUTOMATIC ANALYSIS OF SLEEP EVENTS Go to the Analysis menu Options automatic analysis of events Ignore events in lights on period Apneas and hipopneas Minimum flow drop percentage apneas Minimum flow drop percentage hipo
13. Brand Names Bitmed is a registered trademark of Sibel S A Windows is a trademark of Microsoft Corporation 534 740 MU2 REV 1 05 PRODUCT IN COMPLIANCE WITH MEDICAL DEVICE DIRECTIVE 93 42 EEC CLASS 0197 Thank you for choosing this product The BitmedLab software is designed and manufactured with the best guarantees of quality Applications of BitmedLab software will open a world of possibilities in the sleep study If you have any possible improvement for this product we welcome your suggestions may be directed to Customer Service Department Revised Approved Date 2013 11 Date 2013 11 Technical Director Sales Director 534 740 MU2 REV 1 05 Table of Contents BitmedLab User s Manual TABLE OF CONTENTS 1 INTRODUCTION iia qa REA QE M RA DN AQUR IE QNOD RR AER e 1 1 WHAT IS BITMEDLAB SOFTWARE 11 Lu INTENDED USE MEUM 12 1 3 INDICATIONS FOR USE 12 1 4 SAFETY PRECAUTIONS AND RECOMMENDATIONS 13 1 5 PRODUCT DISPOSAL Fi RR AO RE RR Rain 14 2 INSTALLING THE SOFTWARE us 1 2 1 6 15 2 2 INSTALLING 15 2 3 INSTALLING THE USB DRIVER
14. The test will start playing exactly as it was acquired If you wish to double the playing speed click on the x2 button Increase the test playing speed If you wish to decrease the playing speed by half click on the 2 button Decrease the test playing speed You can stop playing the test at any time by clicking on the Pause playing test button 8 You can start playing the test from the same point where it was stopped by clicking again on the Start playing test To stop playing the test click on the Stop playing test button The difference between this button pause button is that when play is resumed it does so from the beginning of the epoch on the screen 4 6 5 SCROLLING THROUGH THE TEST Using the time bar The time bar allows the user to scroll through the test quickly Simply drag the scroll bar to move to another moment in the test Scrolling will take place in the window that is active at the time framed in yellow The current time and the total duration of the test is shown to the right of the scroll bar ohosm 534 740 MU2 e REV 1 05 BitmedLab User s Manual Using the keypad The following keys are used to scroll through the test Start moves to the beginning of the test End moves to the end of the test Page down goes to the next epoch Page up goes to the previous epoch Left arrow goes back a short time in the epoch Right arrow goes forward a short time in the epoch F
15. enue A 8281 User s Manual Software BitmedLab BitmedLab User s Manual Hiding showing the trends window The trend window displays a bar for each type of event The occurrence of each event is marked with a color rectangle on this bar The number of occurrences of each event type appears next to each bar These bars are normally used to get a general idea at a glance of the trend of events over a long epoch of the test or the complete test The trends window can be shown or hidden by clicking on the T button of the Viewing bar or by clicking on the See gt Trends menu Moving events Place the cursor over the event to be moved The cursor changes as shown in the illustration Click on the event and drag it while left clicking Release the left click when the event mark is in the desired position Changing event duration Place the cursor over the left or right end of the event The cursor changes as shown in the illustration Click and move the cursor to the left or right while maintaining the left click Release the left click when the event mark is in the desired position Changing event types Place the cursor over the event you wish to change and right click A menu will appear with all the event types defined in the 534 740 MU2 REV 1 05 BitmedLab User s Manual application Choose the type of event to assign to the event Obstructive 5 0 8 0 012 095 fA a
16. upper v cams Ed re A EE a2 16 201 02 1 Pulso 33 C Bipolar 2 Sa02 34 Reference Avg ref D 3 0 DCI Pos pca D 5 EEGI t8 Display the Reference list and choose the reference that you wish to use for the channel This can be any of the other reference electrodes or an averaged reference setting up an averaged reference is explained further along Configurations Montage Test Traces Power frequency time Power frequency map Video Recording window upper v Foil Feel u r 2 A e 0 15 63 rz ion 02 ecan _ 3 o 60 5402134 m o EGA m Pos 002 O EEG 5 O EEG O 7 Click on Set up reference The channel input in the list of visible 534 740 MU2 REV 1 05 qe enue A 5 98 User s Manual Software BitmedLab BitmedLab User s Manual channels changes Configurations Montage Test Traces Power frequency time Power frequency map Video Recording window upper v mj o mg ra re ra re 2 A
17. Central hypop Mixed Snore Flow lim Zoom to selection Copy selection Delete Export to new file Export ASCII Unselect The event mark will appear The mark can appear over one more waveforms depending on the property settings of the event type If the trends window is open a mark will also appear on the corresponding event type bar and the length will depend on the duration of the event Finally the number of event occurrences will increase by one 534 740 MU2 REV 1 05 21e 3Jogs enue A 5 281 User s Manual Software BitmedLab BitmedLab User s Manual 0n02m00s Marking events with the keypad Press the key associated with the event The program will insert a mark starting at the beginning of the epoch on the screen with a specific duration for this type of event Refer to the Customized keys tab of the Settings Tools Options window for the key associated to each type of event The hotkeys are also listed in Annex 3 in this manual Marking event with the mouse and the keypad Press on the key associated with the event that you wish to mark The cursor changes to an arrow with the sign Do not release the key and select the part of the test where you want to mark the event Release the key to mark the event There is another way to mark events with the keyboard and mouse Press the key next to the event you want to dial an
18. Configuration aman E Airflow prezure E nable thie channe enzo EJ Enable thit chanre SENED Thoracic hand E nable channe ENEE El Abdominal effort band Enable this chanre E Auraliery The program will request the folder and name with which to store the test offering a default name Click on Save to start the test Do not turn off the PC when performing a real time test Stop the real time test first 3 8 2 COMPLETING TEST ACQUISITION Click on the Finish test button The test acquisition will stop after a few seconds and the device will stop recording data in the memory card 3 8 3 SIGNAL TEST Entering and exiting the signal test mode while the test is being performed At any time during the performance of the test the user can use the Signal test button on the Test toolbar to momentarily stop recording the data from Sleep amp Go in the PC However the 534 740 MU2 REV 1 05 qe enue A 8281 User s Manual Software BitmedLab BitmedLab User s Manual biomedical signals will continue to be displayed on the screen Use this option for example to relocate a sensor that has moved or been placed incorrectly and to check changes in the sensor signal without any of it being stored in the test OhO00m05s SIGNAL TEST MODE NO DATA WILL BE SAVED 0 00 105 To cont
19. s configurations Device New scheduled test Transfer tests Database BitmedLab User s Manual Revision 534 740 02 Rev 1 05 All rights reserved This manual can be purchased from the Technical Assistance Service SIBEL S A Rossell 500 08026 Barcelona Spain National Sales Tel 93 436 00 08 e mail comercial sibelmed com International Sales Tel 34 93 436 00 07 E mail export sibelmed com Technical service Tel 34 93 433 54 50 E mail sat sibelmed com Fax 4 34 93 436 16 11 Website www sibelmed com SIBEL S A belongs to SIBELGROUP WARNING REGARDING THE COPYRIGHT No part of this publication can be reproduced transmitted transcribed stored on a back up system or translated to any language or computer language in any form or medium whether electronic mechanical optic chemical manual or any other means without the express written consent of SIBEL S A DISCLAIMER SIBEL S A is responsible for the safety reliability and operation of this appliance only if e The locale where the appliance is installed or used meets the requirements for IEC electrical installation as well as all other regulations that might pertain e The repairs revisions or modifications both within and without the warranty period are performed by MEDITEL Ingenier a M dica S L or SIBEL S A technical personnel e The product is used by qualified personnel and according to the recommendations made in this User s Manual
20. 0 52 yV2lHz 0 50 y V2lHz 0 49 pV Hz 0 47 0 45 0 43 pV Hz 0 44 0 0 0 8 O 32pVHz 0 3192 Hz 0 20j V2 Hz 0 27 VA Hz 0 25y V2 Hz 0 23 y VA Hz 0 2202 Hz 0 209 VA Hz 0 18yVzHz 0 16 0 13 2 0 11 2 0 09 0 07 0 05 2 0 0 0 02 yV2 Hz 0 00 jA2 Hz 250 Frequency Hz Press F1 for help 1 mm s 233 8 5 EEGLab Test 08D54D57 F6A5 4A68 BA20 m Archivo Edici n Equipo An lisis Herramientas Ventana Ayuda NUI YE M YR banda sp 8 Qi x 2 total 6h Customized montage v 7 wiliHz 35 50 Hz Y 5 Power 0800 0 OhO1mO0s Power p VA Hz 0 56 pVyHz O 54y tHz O 52p AtHz 0 50 2 0 49 paH 0 47 0 0 4 0 44 0 40 O 38p tHz 0 36 p tHz O 34p tHz O 32p AtHz 0 34 0 29 p AtHz 0 27 0 25 p tHz 0 23 p tHz 0 221 0 20 0 18 gt 0 16yV2 Hz 4 0 13 2 0 11 2 0 09 2 0 07 2 0 05 2 O 04p AtHz 0 02 p ArHz O 00pverHz Frequency Hz Press F1 for help 1 mm s 233 8 5 534 740 MU2 REV 1 05 BitmedLab User s Manual 7 2 CHANG
21. As a result the inlet description in the list of visible channels will change Configurations Montage Test Traces Power frequency time Power frequency Video Recording window m ogl Eogr es ec en v ae T1 Channel Oo 1 33 v Bipolar 2 5 02 34 Reference Avg ref v O 3 DC DC1 EG 4 Pos Set reference m 60 Pos DC2 Delete oO EEG 8 Edit average reference 534 740 MU2 e REV 1 05 qe enue A 8281 User s Manual Software BitmedLab BitmedLab User s Manual Click on Accept to see that a new channel has been created as a result of referencing one inlet channel to another Editing the averaged reference Go to the Analysis menu Viewing options Enable the Montage tab Click on Edit averaged ref A window will open from which to modify the averaged reference The electrodes that comprise the averaged reference appear with a green mark while those that are not used appear with a red mark Average reference 15 C Show weights Select the electrodes that comprise the averaged reference by clicking on them and changing the color of the mark from red to green If the Show weights option is enabled the name of each electrode will be replaced wi
22. First name Sumame Sex Female v Date of birth Year 1980 Month 1 Day 1 Address EM _ ue Province City Tiii ZIP code Telephone Cell phone Fax E mail Weight Height m 0 BMI 0 Insurance Insurance company policy Medical history Modifying an existing patient Have the database window open select the patient to edit from the patient list and click on the Edit patient button Edit the patient data in the Patient window click on Accept Deleting a patient Have the database window open select the patient to delete from the patient list and click on the Delete patient button be Confirm that you wish to delete a patient 4 2 2 ASSOCIATING DOCUMENTS TO A PATIENT The user can associate documents of any kind to a patient such as images text documents PDF files etc Have the database window open select the patient to associate to a file and click on the Associated documents button Click Associate file in the Associated files window 534 740 MU2 e REV 1 05 BitmedLab User s Manual Click on the Browse button in the Associate file window and choose the file that you wish to associate with the patient Select the document being linked to the patient Browse j Cancel The file appears listed in Associated files Linked documents Files C Docume
23. The Device identification wizard will start up If you have a Sleep amp Go system with a Bluetooth module mark the option Yes my device has Bluetooth communication If not select the option No my device does not have Bluetooth communication Click on Next 534 740 MU2 e REV 1 05 qe enue A 8281 User s Manual Software BitmedLab BitmedLab User s Manual Welcome to the device identification wizard The program will detect now your device to start working with it Please select if your device is equipped with the Bluetooth option 9 Yes my device is equipped with Bluetooth Bitmed Sleep amp Go model with Bluetooth module No my device is not equipped with Bluetooth Bitmed Screen amp Go model or Bitmed Sleep amp Go without Bluetooth module If you have a Sleep amp Go system with a Bluetooth module make sure that the Bluetooth module is running and select the Bluetooth communications port that the device is connected to you can find this in the Windows Control panel If not remove the memory card from the device and insert it in the PC card reader remember to switch off the device before removing the memory card Click on Next The device will be detected now by Bluetooth Check that the device is turned on and the Bluetooth connectivity is enabled Click on Next to start the detection Blutooth communications port 534 740 MU2 REV 1 05 B
24. e Import record 534 740 MU2 e REV 1 05 qe enue A 8281 User s Manual Software BitmedLab BitmedLab User s Manual Other important issues Printing documents In the case of storage of paper prints containing patient details it is required that these documents remain duly safeguarded in such a way that only duly authorized personnel have access to them Likewise in the case of a user deciding to dispose the printed documents it will be necessary to ensure their effective physical destruction in order to avoid unauthorized access to the data Exporting tests Once the test has been exported to a file the software user is responsible for the security of said file and its later deletion Data transmission The software permits the transmission of files with patient data via the internet If this functionality is used the user must configure their e mail server so that the data is encrypted before transmission and is therefore converted into unintelligible data for any unauthorized access 534 740 MU2 REV 1 05 BitmedLab User s Manual ANNEX 3 HOTKEYS Insert note Insert Increase amplitude of selected waveforms Up arrow Start pause playback Ctrl Espace Select all waveforms Ctrl Tab Increase time per epoch x2 Insert navigation anchor Ctrl M Move to the start of the test Home Move to the previous epoch Page up Move one second back Le
25. name_pat label with the real name of the patient so the report shows something similar to the 534 740 MU2 REV 1 05 BitmedLab User s Manual following Name Paul Garralda If on the contrary the template has Total recording time min the generated report will replace the TRT label with the total recording time Total recording time 182 min Any of the report templates supplied by default with the program can be opened in your usual text processor to verify its appearance Refer to the CD supplied with the software to familiarize yourself with the complete list of available labels to customize your reports Briefly the steps to create a report template are as follows Open a word processor such as WordPad or MS Word Create a new document or edit any of the report templates in the Templates folder Customize the report You can use tables format the text bold various fonts colors insert images etc The text entered will appear the same in the report while the labels with the Zname _ label format will be automatically replaced with a value calculated by the program When you have finishes save the file with the RTF extension in the Templates folder The new template will appear in the list of available templates for the generation of reports 534 740 MU2 REV 1 05 21e 3Jogs enue A 5951 User s Manual Software BitmedLab BitmedLab User s Manual 4
26. the tachycardias will be seen perfectly Take the following steps to change the group of event types Go to the Too s menu Options Choose the Event types tab Choose the group you wish to use from the list of Group of event types Click on Accept to apply the changes 4 6 25 MANUAL MARKING OF SLEEP EVENTS Marking events with the mouse Click on the point where you wish to start the event Drag the mouse to mark the duration of the event The duration of the current selection will appear in the status bar in seconds If you have clicked on an air flow or breathing effort waveform the desaturation associated with the selection and the signal variation will also be shown These data are useful for marking apneas and hypopneas Desat 6 Var 82 3 Sel 16 265 When the selection has been completed a contextual menu will appear with all the event types Choose the one you wish to mark 534 740 MU2 REV 1 05 BitmedLab User s Manual Obstr apnea Central apnea Mixed apnea Arousal Desaturation Movement Obstr Central hypop Mixed hypop Snore RERA Flow lim Mov aro Tachycardia Bradycardia PLM Bruxism Periodic brea Cheyne Stokes brea Undetermined resp event Zoom to selection Frequency spectrum Copy selection Delete Export to new file Export ASCII Unselect ry ng The event mark will appear The mark can appear over one or more wa
27. 13 08h 00m 11192 168 0 1441BitmedLab tests BSE1C318 895E 46DB These two functionalities make it easier for user to find work that is still pending Double click on any of the tests to open them 4 3 IMPORTING AND EXPORTING TESTS Importing tests Select the patient to whom you want to add the test and click the Import test button In the Import dialog box select the test file to be added using the Browse button and click on Import The test will be added to the patient 534 740 MU2 REV 1 05 BitmedLab User s Manual Import test Select the test be bo the dalabaze Exporting tests To export a test select it in the database and click the Export test button In the Save As dialog box select the name and path to the file where the file will be saved 4 4 PERFORMING THE TESTS IN REAL TIME A test in real time is a test that is performed while the device is connected to the computer so that the biomedical signals that are acquired are viewed in real time on the computer screen Do not turn off the PC when performing a real time test Stop the real time test first The tests are stored in the hard disk of the computer in a file with xgp extension However for security reasons the test is also stored in the internal memory of the device as long as there is enough available space Video synchronized with the biomedical signals ca
28. BitmedLab BitmedLab User s Manual to each channel Go to the Device menu Device manager In Device manager click on Set up the device for holter mode Device manager Available devices Device Number Comm Serial number Status Apnea 14 USB 8006112901 Connecter Make default device a A R d 8 d lt 1 available device s The Viewing options will appear as though you were going to perform a real time test or download the device memory If you have created a montage with the channels you wish to acquire and their frequencies you can use this Otherwise change the sampling frequencies of each channel as specified below Click on Accept when you are done The software will set up the device and it will be ready to record in holter mode 4 5 4 DOWNLOADING THE TEST Once the test has been completed see the detailed explanation on how to perform a test in holter mode in the device manual it must be downloaded to the PC for review Have the database window open and choose the corresponding patient in the list Click on Download memory The Viewing options dialog box will appear Enter the set up options of the test in this box sensors used during the test filters epoch duration etc These data can be customized each time a new test is started in holter mode but it is more convenient to save all the parameters under a default configurati
29. Display range waua 79 Lis Min waue 1 75 y Close You can enter the text regarding the position of the electrode in the Additional description text box by hand or click on the header icon which will open the Electrodes map 534 740 MU2 e REV 1 05 qerpounrg o1eA 3Jog Tenueyy 5 1281 User s Manual Software BitmedLab BitmedLab User s Manual Electrode map In the Electrodes map click on the electrode connected to the channel that is being set up and click on Accept The name of the electrode will be added automatically to the Additional description text box in Channel properties Click on Close to close Channel properties Verify that the name of the channel has been changed in the list of visible waveforms of the Montage tab and the name of the electrode that has been connected to the channel appears in its place Creating a derivation by establishing a channel reference Open the Viewing options window from the Analysis menu gt Viewing options Enable the Montage tab Select the waveform window of the channel that you want to establish a channel for In the list of visible waveforms choose the channel that you want to establish a reference for Remember that the chosen channel must be a reference channel 534 740 MU2 REV 1 05 BitmedLab User s Manual Configurations Montage Test Traces Power frequency time Power frequency map Video Recording window
30. Eogr Fa re ra ra e RARA Ct 14 122 26 ta es ee pal re d 2 02 24 29 02 Channel o ECG 1 33 m EEG saoz 30 Reference Avg rel 3 DC DC1 ecw 002 m EEG EGE EGN When all the desired channels have been added click on Accept to close the window and apply the changes 534 740 MU2 REV 1 05 BitmedLab User s Manual 4 6 14 DELETING WAVEFORMS Go to the Analysis menu gt Viewing options Enable the Montage tab Choose the top or bottom waveform window that you wish to set up from the Waveform window list Choose the visible waveforms that you wish to delete from the waveform list Click on Delete and the waveform will disappear from the list of visible channels Click on Accept to close the window and apply the changes 4 6 15 DELETING ALL THE WAVEFORMS Go to the Analysis menu gt Viewing options Enable the Montage tab Choose the top or bottom waveform window that you wish to set up from the Waveform window list Click on Delete all to delete all the waveforms at once Click on Accept to close the window and apply the changes 4 6 16 SETTING UP THE SENSOR ASSOCIATED TO EACH INPUT CHANNEL Before acquiring a new test or reviewing an existing test the software must know which sensors signals were connected to each of the input channels in the Bitmed recording device When
31. Manage memory configurations Make sure you have inserted the memory card in the PC card reader and click on Next Function selection What do you want to do Set the configuration used in manually started tests via Bluetooth The following window shows a list of device configurations in the memory card Remember that there can be no more than ten configurations in the memory card at the same time Any of these configurations can be deleted by clicking on the Delete button 534 740 MU2 REV 1 05 qe o1eA 3Jog enue A 7950 User s Manual Software BitmedLab BitmedLab User s Manual Configurations in the memory card Add pre Delete Any of the configurations defined in BitmedLab can also be added by clicking on the Add button In the new window choose one of the configurations in the list You can modify a setting in the list or create a new one by clicking on the Edit PC configurations button The graph shows the channels that will be acquired green or not red depending on the setting chosen You can also edit a configuration in situ activating or deactivating channels by clicking the appropriate button If you also want to save the changes as a new configuration click the Save button and the program will ask for a name for the configuration Click on Next Configurations Configuration selection Configurations available in the PC a
32. PERFORMANCE OF REAL TIME TESTS M a AER 162 5 2 MODIFYING THE CAPTURE PROPERTIES 164 9 0 REVIEWING THE TEST aBHAEEE S E REA 166 5 4 COMPRESSING THE VIDEO FILE AUTOMATICALLY AFTER COMPLETING THE TEST 167 5 5 COMPRESSING THE FILE AT ANY TIME 167 5 6 COMPRESSING A VIDEO FILE USING THE COMPRESORAV TOOL Pe ee rr P 168 5 7 CHANGING THE VIDEO FILE ASSOCIATED WITH A TEST ee ere ee ee ee eee rr ee eet rr ee eee 168 6 FREQUENTIAL ANALYSIS TOOLS T 170 6 1 FREQUENCY SPECTRUM GRAPH 170 6 1 1 DISPLAYING THE FREQUENCY SPECTRUM GRAPH 170 6 1 2 MODIFYING THE FREQUENCY SCALE 171 6 1 3 PRINTING THE FREQUENCY SPECTRUM GRAPH 172 6 1 4 EXPORTING FREQUENCY SPECTRUM DATA 172 6 2 THE POWER FREQUENCY TIME GRAPH 172 6 2 1 DISPLAYING THE POWER FREQUENCY TIME GRAPH MM M 172 6 2 2 MODIFYING THE COLOR SCALE 174 6 2 3 CHANGING THE FREQUENCY SCALE 174 6 2 4 SHOWING THE GROUPED FREQUENCIES BY FREQUENCY BANDS aai aani Ond inae c Cac o a a 175 6 2 5 PRINTING THE POWER FREQUENCY TIME VIEW 176 534 740 MU2 e REV 1 05 sjuojuo JO o qe L Table of Contents BitmedLab
33. SENEO El Thoracic efhort hand E nable chenre E Abdominal effort band Enable thie chanre E The following configurations are supplied by default with the software CSCR Screen amp Go basic model CSCRSPO Screen amp Go model with pulseoximetry option CSLPA Sleep amp Go A model CSLPB Sleep amp Go B model CSLPBEXG Sleep amp Go B model with ExG module In the Configurations window click the W button to add a new configuration Then select the polygraph model for which the configuration will be created Editing of channels to be acquired during the test will be enabled Select the ones to use and configure the sensors that will be connected to each of them You can also change the sampling rate of some of them However others have a fixed sampling rate and can not be changed Do not forget to enter up to 8 characters in the Name field When finished click the button to save the changes or the button to discard them Use the o button to delete the configuration selected in the Configurations list 534 740 MU2 REV 1 05 qe o1eA 3Jog enue A 5 280 User s Manual Software BitmedLab BitmedLab User s Manual Finally the button allows you to modify the configuration selected in the Configurations list Again use the buttons to confirm or discard changes The following characters are available for the c
34. all these have been set up the changes can be saved as a default configuration that can be used afterwards Go to Analysis menu Viewing options and enable the Montage tab Assuming that the channel is already in the list of visible channels 534 740 MU2 REV 1 05 qerpounrg 1105 enue A 7950 User s Manual Software BitmedLab BitmedLab User s Manual double click on it or select it and click on Properties The Channel properties window will open In the Signal type list select the sensor that has been connected to the corresponding channel of the device If the sensor you wish to connect to the device does not correspond to any of those that appear in the list of signal types contact Sibel S A for instructions on how to use it Channel settings Input channel Sensor Customized sensor Comments Flow theimocouple Color M Inverted signal values aver the channel Snorng microphone Low pass fille Snoring piezo Snoring ransducer EOG Sencitiviy Input range Max value Body position Body position BITMED Click on Close to close the window Click on Accept in the Viewing options window to apply the changes During the performance of the test check that the sensor connected to each channel corresponds to the selected channel configuration 4 6 17 CHANGING THE SOFTWARE FILTERS The low pass and high pass filters applied to each channel can be c
35. between two arterial points in this case between the place of acquisition of the ECG signal to the tip of the finger where the pulse oximeter is placed This is a calculated channel that displays 0 during performance of real time tests and that the program has to calculate once the test has finished Perform the test making sure to correctly place a pair of ECG electrodes the patient s ground electrode and the pulse oximeter Remember to acquire the ECG and pulse wave channels Once the test is finished go to Analysis Calculate PTT The program will calculate the PTT data and update the PTT waveform 534 740 MU2 REV 1 05 qerpounrg 1105 enue A 7950 User s Manual Software BitmedLab BitmedLab User s Manual To perform the calculation the program uses the ECG channel selected in the automatic analysis options Analysis Automatic analysis options If the PTT waveform is not visible on the screen it can be shown as any other waveform by going to Analysis Viewing options enabling Montage and clicking on the button In the report the program will show a series of data associated with the PTT such as the number and rate of increases decreases maximum and minimum values etc 3 9 28 PRINTING The SleepLab software module allows the user to print both the epoch being viewed on the screen and a selection of several epochs consecutive or not or the entire test Printing the on screen epo
36. finished click on Next gt 1 01 InstallShield Wizard Choose Destination Location Select folder where set Jp Install 7 10 to de pragramahBilmed EkmedLab 1 01 On the next screen choose the elements that you want to install 534 740 MU2 REV 1 05 qe enue A 8281 User s Manual Software BitmedLab BitmedLab User s Manual In BitmedLab Elements choose the modules that you want to install SleepLab and SleepLab Pro The functionalities of each of these modules is described in Section 1 1 The PDF printer allows you to print the reports generated by the program in PDF format while the XGPVIsion module allows you to acquire synchronized video assuming you have obtained the corresponding license Click on Next BiimedLab 1 01 InstallShield Wizard Select Features Select leaut val iretal Select the fembures pou to install and deselect the heobures pou mak wart bo abal Pro Ey Common features pe pe 31 BI MB of spere required onthe C drive 4625 Eh MB al space avalan onthe C dive install Sieli lt Back 1 gt EN Cancel The installation program will copy the selected files If you chose to install the PDF printer the PrimoPDF installation program will start up automaticall
37. in the test will be lost Confirm that you wish to continue The program will begin the analysis The events detected will be 534 740 MU2 e REV 1 05 qe o1eA 3Jog enue A 5 1281 User s Manual Software BitmedLab BitmedLab User s Manual marked on the waveforms and in the event bars of the trends window 4 6 27 MODIFYING THE OPTIONS FOR AUTOMATIC ANALYSIS OF SLEEP EVENTS Go to the Analysis menu Options automatic analysis of events Automatic sleep events analysis settings Common Ignore events in lights on period Ignore events in artifacts Ignore events in wakefulness and hipopneas Minimum flow drop percentage Minimum flow drop percentage hipopne Minimum duration apneas Minimum duration hipopneas Thermocouple airflow channel Pressure transducer airflow channel Pressure transducer airflow channel Use thoracoabdominal sum Delete apneas hipopneas coincidin Central apnea classification criteria Mixed apnea classification criteria Default settings Make the desired changes in the criteria for automatic analysis of events An explanation of each of these parameters is shown when you click on the parameter To return to the program default values click on Reset default parameters Click on Accept to apply the changes 4 6 28 WORKING WITH EVENTS Modifying the default duration for events inserted with the keypad Open the window Too
38. into account e Use in a health center Not intended for monitoring vital signals EKG signal can not be used for heart diagnosis purpose It s only intended for bradycardia and tachycardia detection during sleep analysis 1 3 INDICATIONS FOR USE The BitmedLab software has been designed for being used by a doctor or a technician trained in the acquisition of cardiorespiratory signals in the transmission and visualization of the data in the Personal Computer and in the analysis of the signals Therefore it is not recommended change the configuration of the device without understanding the principles of signal digitalizing Minimum age of patients is 5 years weighing over 15 kg and a minimum height of 70 cm The medical staff will instruct the patient for a correct test execution to avoid interferences in the measurement and to replace the sensors in case of movement It is therefore important that the patient can understand the instructions given by medical staff The intended environments of use are hospitals sleep centres and sleep clinics Tests may also be carried out at the patient s home with the exception of ExG signals EEG EMG EOG EKG In this case the patient is only authorized to start and stop the test and should be adequately instructed by the doctor on this respect 534 740 MU2 REV 1 05 BitmedLab User s Manual Using the BitmedLab software does not involve any monitoring or diagnosis of the
39. key and select the part of the test where you want to mark the event Release the key to mark the event 4 6 26 AUTOMATIC ANALYSIS OF SLEEP EVENTS The automatic analysis of the sleep events is only available if the corresponding license has been purchased 534 740 02 REV 1 05 BitmedLab User s Manual The results provided by the Automatic Analysis of Sleep Stages should not be used as the sole criterion for medical diagnosis or patient treatment The results must be supervised and reviewed by medical personnel with adequate training The program has an option that analyzes the test in order to detect and classify events apneas hypopneas desaturation PLM and limb movement snoring cardiac event tachycardias and bradycardias arousals and RERAs The automatic analysis of events deletes all events marked previously in the test Take the following steps to perform an automatic analysis of sleep event Go to Analysis Automatic analysis of events A window appears where you can select the type of events that you wish the program to detect Click on Accept when you have made the selection Automatic analysis Select the events you want to be detected in the automatic analysis amp pneas hipopneas C Desaturations Snores C Arousals CI RERAs C Spikes Cancel BitmedLab will warn you that all the events marked
40. necessary to download the test to the PC for review and to generate a report To do so remove the memory card from the Screen amp Go Sleep amp Go system and insert it into the PC card reader remember to switch off the device before removing the memory card The take the following steps in the BitmedLab software Click on Download tests in the home screen The download test wizard will start up Click on Next 534 740 MU2 e REV 1 05 BitmedLab User s Manual Welcome to the test download wizard Please insert the device s memory card in the card reader The program will list the tests available the memory card Choose the test you wish to download and click on Next If you wish to delete any of the tests from the card without downloading them to the computer choose the test and click on Delete The test chosen for downloading will be automatically deleted from the memory card when the process has concluded Test download wizard Step 2 4 Ea pui Selection of tests These are the tests stored in the memory card e 5 amp Select the ones to be downloaded START DATE TIME PATIENT 12 22 10 22 00 00 Delete Update If the test was started automatically the program will automatically associate the test with the patient selected during test programming If the test was started manually the patient associated with the test must be selec
41. of frequencies you wish to view and click on Accept to apply the changes 534 740 MU2 e REV 1 05 qe enue A 8281 User s Manual Software BitmedLab BitmedLab User s Manual 6 1 3 PRINTING THE FREQUENCY SPECTRUM GRAPH Make sure that the frequency spectrum graph is enables and go to File Print Choose the printer printer properties printing interval and number of copies Click on Accept to start printing 6 1 4 EXPORTING FREQUENCY SPECTRUM DATA The frequency spectrum data can be exported to a text file Right click on the frequency spectrum graph Choose Export as text in the contextual menu Enter a name in the Save as dialog for the file that will contain the exported data 6 2 THE POWER FREQUENCY TIME GRAPH 6 2 1 DISPLAYING THE POWER FREQUENCY TIME GRAPH For each channel selected the power frequency time graph shows the power contained in each frequency throughout the test This graphic display of the test allows the user to easily detect different events such as apneas or hypopneas spindles K complexes or REM stages and is therefore a tool that helps the user evaluate the test The range of frequencies analyzed goes from to 25 Hz although it can also be divided into characteristic frequency bands alpha beta delta theta 534 740 MU2 REV 1 05 BitmedLab User s Manual Frequency Hz 0100 0 1 00 Power 5 00yV Hz 4
42. over the wovchornm The value of tha signal amp deplayed avar tha wavetorm ac regular intar ale 3 9 20 NUMERICAL VALUES CURSOR The numerical value cursor is a vertical line that the user can scroll freely across the screen The status bar shows the value of the signal in the position and the channel that the cursor is on To display it Cursor 97 0 Go to the Analysis menu Viewing options Enable the Viewing tab and mark the box of the Display cursor option Click on Accept to apply the changes Once the bottom waveform window is visible it also displays a cursor that is synchronized with the cursor in the top window always marking the time instant of the top waveform window 534 740 MU2 REV 1 05 qe enue A 8281 User s Manual Software BitmedLab BitmedLab User s Manual 0832 005 0 32 305 Oh33m00s h33m3 s Oh30m00s 0834 005 Oh34m00s 58 60 61 5 55 5 55 50 6 60 57 57 62 58 58 86 58 51 54 60 52 58 67 59 50 56 65 53 51 53 98 98 96 95 97 96 93 96 94 94 92 96 95 93 94 95 94 93 94 95 94 95 95 93 92 94 95 93 91 95 8 02 dcha dcha dcha dcha dcha dcha dcha dcha dcha dcha dcha dcha dcha dcha dcha dcha dcha dcha dcha dcha dcha dcha dcha dcha dcha dcha dcha dcha dcha dcha 3 9 21 MONTAGES A montage stores all the settings of a test under a descriptive name This includes sensors filters gains colors descriptions on screen order epoch dura
43. patient 1 4 SAFETY PRECAUTIONS AND RECOMMENDATIONS The manufacturer is liable for the safety reliability and operation of the devices only if the following points are observed For correct system operation BitmedLab software should be used only with the devices listed in the section above Please read the user s manual of your system before using it Use the device according to the instructions included in the device manual Liability does not cover the effects derived from the use of the software or the device it is connected to The manufacturer or an Authorized Assistance Center performs modifications or repairs The system is used according to the instructions of use The computer monitor and accessories where the software is used meet the low voltage Directive particularly EN60950 standard and EMC Directive particularly 55022 EN61000 3 2 61000 3 3 and EN55024 standards Verify your operating system is properly installed and updated Verify that the hardware of your PC works properly To comply with Medical Devices Directive 93 42 EEC and for safety and reliability purposes ensure that the device and its software are used by personnel that are adequately trained in the intended use of the device 534 740 MU2 REV 1 05 21e 3Jogs enue A 5 281 User s Manual Software BitmedLab BitmedLab User s Manual The software BitmedLab runs on PC Ma
44. selecting the Waveform settings option in the menu In the Waveform settings change the Units property enter the new text and click on OK to apply changes Waveform settings Tick an any property bo change die value Channel sins Sensor saluton Comments Color amping rie 1 MW ew efoam thick ne es Low High pzzs Maximum value mes 100 Minimum value mn 0 Unt Show Wallies aver rz etgim Units sociated wih tha channel signal CPAP channel behaves in a particular way Two types of units can be selected hPa 20 Changing the units automatically updates the minimum and maximum values of the channel The CPAP channel units should also be changed n the polygraph as described in the User s manual 534 740 MU2 REV 1 05 qe 1105 Tenueyy 7950 User s Manual Software BitmedLab BitmedLab User s Manual Waveform settings Tick an property bo change the salue Sensor CRAP pressure Comments Color oou Semana rate Waveform thick ress E nauem Low pase High paz fiker Maximum vake mas 13 61260 13 612301 Minimum value mr 00000 n anam HPs Show valies over the wavelorm hPa Umts Units assiocished vath the channel signal 3 9 14 HIDING OR SHOWING SEPARATION BETWEEN WAVEFORMS Open the Viewing options window from the Analysis toolbar button or from Analysis m
45. the PgDn key to review all the epochs until the beginning of the next sleep stage and mark it The new mark will go from the 534 740 MU2 REV 1 05 21e 3jogs enue A 5 28 User s Manual Software BitmedLab BitmedLab User s Manual beginning of the current epoch to the end of the test OhOOmOOs Oh15m00s Oh3sOm00s Oh465m00s Lights S stages Repeat the point above until you reach the end of the test Second stage marking method In Tools gt Options enable the Genera tab make sure the Advance epoch when stage is entered is enabled Close the window Place the cursor at the beginning of the test Enter the stage corresponding to the first epoch To do so use the corresponding button in the sleep toolbar or the key associated with the stage The software will introduce a mark for that epoch and advance automatically to the second epoch mios Oh15m00s Oh30m00s 0946 05 Enter the sleep stage corresponding to epoch on the screen The software will automatically go to the next epoch 0100 mol Oh15m00s Oh30m00s 0145 00 Lights 5 stages Repeat the point above until you reach the end of the test Keys associated to each of the stages Each sleep stage has an associated default key to enable stage marking with the keypad The default keys are as follows Artifacts A Waking V REM R Stage 1 1 Stage 2 2 534 740 MU2 REV 1 05 BitmedLab User s Manual
46. the capture properties of the card brightness contrast saturation etc Select the input source and the input signal type camera video The available properties will depend on the model of the capture card in the system and some of the options mentioned may be in another menu Normally the values needed are Composite video and PAL system Video Source Settings E m Video Source Composite S Video C MXC m Standard NTSC PAL m Equipment Camera C WCR 50 r Picture Adjustment Brightness Contrast T 25 Saturation 25 T Hue 50 Default 534 740 MU2 REV 1 05 BitmedLab User s Manual Format this establishes the size of the capture window the format of the images to be recorded etc If you have a Winnov Videum 1000 Plus capture card we recommend using the Hardware compression format with a window size of 320x240 and selecting the desired compression quality If you do not have a Winnov Videum 1000 Plus card possible settings could be a similar window size but an image format of 24 bit RGB Flip Horizontal Vertical YUY2 Flip m Capture Dimensions Standard 320 x 240 C Custom Data Format Compression Format Black and White wii Hardware compression Compression Ratio Best Quality J Quality
47. the device memory This ensures that there is enough space in the internal memory of the device for the new test Before deleting the contents of the device memory make sure that all test that you are interested in keeping have been downloaded to the PC The deletion procedure will eliminate all the tests stored in the memory The user will not be able to choose which tests to delete and which tests not to delete Go to the Device menu Device manager In the Device manager click on Delete the device memory Device manager Available devices Device Number Comm Serial number Status Apnea 14 USB 8006112901 Connecter Make default device LI ij amp og Delete device memory 1 available device s Once the memory has been deleted the device must be switched off and on again for the new tests to be saved to the device memory 4 5 3 SETTING UP THE DEVICE Before starting the test in holter mode the device has to be prepared for the test This basically consists in setting up the sampling frequencies of the channels in the Bitmed eXea system If the user always performs the same type of test the device only needs to be set up once By default all the channels record at a sampling frequency of 100 Hz but this can be changed depending on the sensors connected 534 740 MU2 REV 1 05 qe o1eA 3Jog Tenuey 5 1280 User s Manual Software
48. the driver 534 740 MU2 REV 1 05 qe enue A 8281 User s Manual Software BitmedLab BitmedLab User s Manual 2 3 1 WINDOWS XP Connect the eXea system to a free USB port in the PC The New hardware found wizard will start up immediately Choose Not at this time and click on the Next button Found New Hardware Wizard Welcome to the Found New Hardware Wizard Windows will search for current and updated software by looking on your computer on the hardware installation CD or on the Windows Update Web site with your permission Read our privacy policy Can Windows connect to Windows Update to search for software Yes this time only Yes now and every time connect a device not this time Click Next to continue In the next screen choose the option Install from a list or specific location advanced and click on Next Found New Hardware Wizard This wizard helps you install software for exim Apnea If your hardware came with an installation CD lt 6 or floppy disk insert it now What do you want the wizard to do Install the software automatically Recommended Click Next to continue In the following window select Search for the best driver in these locations and Include this location in the search Choose the USB Drivers folder in the BitmedLab CD and click again on Next 534 40 MU2 REV 1 05 BitmedLab User s Manua
49. tree with the tests and documents associated with the selected patient The information is updated every time a different patient is selected Each test includes the start date and time duration and status of the test You can also associate any type of file to the patient under the Documents branch More information on how to do this can be found below 534 740 MU2 REV 1 05 qe o1eA 3Jog enue JA 6 1281 User s Manual Software BitmedLab BitmedLab User s Manual PATIENT H SURNAME BESH 236398 ban Elle LBS4783321 Ramirez Fh4b25EH wacap 3 6 1 ADDING MODIFYING AND DELETING PATIENTS Adding a patient to the database In the database window click on the New patient button Fill in the patient data in the Patient window and click on Ok 534 740 MU2 REV 1 05 BitmedLab User s Manual Patient First name Surname Sex Female Date of birth Year 1980 Month 1 Day 1 Address City Rind ZIP cede 7272 Telephone Cell phone Fax E mail Weight kg 0 Height 0 BMI 0 Insurance Insurance company policy Medical history Modifying patient data In the database window select the patient to edit from the patient list and click on the Edit patient button 27 Edit the patient data in the Patient edit window click on Ok Deleting a patient from the database In the database window select the patient to delet
50. 4 6 17 CHANGING THE SOFTWARE FILTERS 130 4 6 18 CREATING EEG EOG DERIVATIONS 130 4 6 19 CHANGING THE SIGNAL WAVEFORM COLOR 137 4 6 20 DISPLAYING THE WAVEFORM VALUES 138 4 6 21 NUMERICAL VALUES CURSOR 139 4 6 22 DEFAULT CONFIGURATIONS M 140 4 6 23 AUTOMATIC ANALYSIS OF SLEEP STAGES 144 4 6 24 EVENT 147 4 6 25 MANUAL MARKING OF SLEEP 44148 4 6 26 AUTOMATIC ANALYSIS OF SLEEP EVENTS 150 4 6 27 MODIFYING THE OPTIONS FOR AUTOMATIC ANALYSIS OF SLEEP EVENTS MNA 152 4 6 28 WORKING WITH EVENTS E 152 4 6 29 157 4 7 GENERATING REPORTS 158 4 7 1 GENERATING A REPORT 158 4 7 2 PRINTING A 159 534 740 MU2 e REV 1 05 BitmedLab User s Manual 4 7 3 SAVING A REPORT TT m n 159 4 7 4 CHOSING THE REPORT EDITOR ee 160 4 7 5 GENERATING AND MODIFYING REPORT TEMPLA errr Au IE rte er rrr 161 5 ACQUIRING DIGITAL VIDEO 162 5 1 ACQUIRING VIDEO DURING
51. 6 MANAGING PATIENTS AND TESTS THE DATABASE 49 3 6 1 ADDING MODIFYING AND DELETING PATIENTS 50 3 6 2 ASSOCIATING DOCUMENTS TO A PATIENT 51 3 6 3 SEARCHING IN THE DATABASE m 52 3 6 4 TESTS PENDING REVIEW OR 52 3 7 IMPORTING AND EXPORTING 53 3 8 PERFORMING TESTS IN REAL TIME ONLY Ri Icio REM 54 3 8 1 STARTING THE REAL TIME 6 54 3 8 2 COMPLETING TEST ACQUISITION 55 3 8 3 SIGNAL 6 55 3 9 REVIEWING THE TESTS E 3 9 1 USER INTERFACE ELEMENTS DURING TEST REVIEWS y 3 9 2 OPENING A TEST 58 3 9 3 FULL SCREEN 58 3 9 4 DOUBLE WAVEFORM WINDOW 59 3 9 5 PLAYING THE TEST 59 3 9 6 SCROLLING THROUGH THE TEST 60 3 9 7 ADJUSTING TIME ON THE 61 3 9 8 NOTES 63 3 9 9 ADJUSTING WAVEFORM 65 3 9 10 ADJUSTING WAVEFORM 512 5 67 534 740 MU2 e REV 1 05 sjuojuo JO o qe L Table of Contents BitmedLab User s Manual 3 9 11 MODIFYIN
52. 8281 User s Manual Software BitmedLab BitmedLab User s Manual Click on Accept to apply the changes 3 9 23 AUTOMATIC ANALYSIS OF SLEEP EVENTS or patient treatment The results must be supervised and The results provided by the Automatic Analysis of events should not be used as the sole criterion for medical diagnosis reviewed by medical personnel with adequate training Go to the Analysis menu Automatic analysis of events The Automatic analysis of events wizard will start up Choose the event types that you wish to detect automatically and click on Next Automatic sleep events analysis wizard Step 1 4 Events to be detected Select the events that will be detected Apneas hipopneas Desaturations cardias bradycardias In the next step of the wizard choose the part of the test that you wish to analyze If you wish to discard set times at the beginning and or end of the test mark the option Discard epochs at beginning and or end of the test and enter the number of minutes to discard in each case The test can also be analyzed between any two given marks see the Notes section for insertion of a note in the test by simply selecting the option Perform the analysis between two marks By default the program includes marks for Test start and Test end in order to analyze the entire test 534 740 MU2 e REV 1 05 BitmedLab User s Manual
53. 94 4 USING THE PROGRAM WITH THE EXEA SYSTEMS 96 4 1 BEFORE STARTING m 96 534 740 MU2 e REV 1 05 BitmedLab User s Manual 4 1 1 START THE PROGRAM er 96 4 1 2 REGISTERING THE IN THE 96 4 1 3 ENTERING USER 97 4 2 MANAGING PATIENTS AND TESTS THE DATABASE 98 4 2 1 ADDING MODIFYING AND DELETING PATIENTS 99 4 2 2 ASSOCIATING DOCUMENTS TO A PATIENT 100 4 2 3 SEARCHING IN THE DATABASE M 101 4 2 4 TESTS PENDING REVIEW OR 101 4 3 IMPORTING AND EXPORTING TESTS X 102 4 4 PERFORMING THE TESTS IN REAL TIME aaa dins 103 4 4 1 STARTING THE REAL TIME TEST 104 4 4 2 PAUSING AND RESUMING A 106 4 4 3 COMPLETING TEST 0161 107 4 4 4 MEASURING IMPEDANCES enne 107 4 4 5 SIGNAL 5 555 a Rau RE ERR ERR CER M 108 4 4 6 USING THE TIMER IN REAL TIME TESTS 109 4 5 PERFORMING TESTS IN HOLTER 119 4 5 1 CONSULTING DEVICE FREE TOTAL MEMORY 110 4 5 2 DELETING THE DEVICE MEMORY E 111 4 5 3 SETTING UP THE
54. A 5 281 User s Manual Software BitmedLab BitmedLab User s Manual 10011155 Audible 205 Entering a note There are two different ways to enter notes Select Enter note in the Analysis menu Press the Insert key on the keypad A box will appear for the user to enter the text of the note The user can also choose one of the predefined notes that appear If the test is being performed in real time the note will appear overwritten at the instant it is being acquired However if a test that has already been acquired is being viewed the note will appear overwritten at the instant corresponding to the center of the screen being viewed at that time Enter TS Tow Modifying a note Right click on the note to be modified Select Modify note in the contextual menu that appears This note Delete note The Enter note window will appear Modify the text and click on Accept to apply the changes Deleting a note Right click on the note to be deleted 534 740 MU2 REV 1 05 BitmedLab User s Manual Select Delete note in the contextual menu that appears his is 8 not Delete note Modify note Showing hiding notes Gotothe Analysis menu Viewing options orfrom the corresponding button of the side toolbar Enable the Waveforms tab Enable the See notes option to show the notes on the screen and disable the option to hide them Click on Accept to apply the changes M
55. Advanced edition EJ pressure thermo Thoeranc effort hdoninal effort LJ Fuke 02 L Fuse newe 534 740 MU2 REV 1 05 BitmedLab User s Manual Click on Finish when you are finished 3 4 PROGRAMMING AN AUTOMATIC TEST Take the following steps to set up your Screen amp Go Sleep amp Go in order to start an automatic test in holter mode at a specific date and time Click on New programmed test in the home screen The wizard for the new programmed test will start up Choose the device that you wish to program Select the polygraph to be programmed Device leep amp Go B model S N 3 Choose the patient associated with the test You can search for the patient by entering any of the patient s data in the Filter field If the patient is not in the database you can add the patient at this time by clicking on New patient Once the patient has been selected click on Next 534 740 MU2 REV 1 05 qe enue A 8281 User s Manual Software BitmedLab BitmedLab User s Manual Patient Select the patient on click on the New patient button PATIENT SURNAME NAME 651287 Gattlin Sam EL New patient Then enter test data including the start date and time of the study and its duration The device will complete the test automatically Click on Next Test data
56. Color MK Inverted Sampling rale 100 Ha 1 Digplay signal valuas over the wevefam Lacal carka Lnmpesrhber High paz LN Notch filer 50H Input range Max waus 7132 122 Display range 75 uv Click on Close when you are done 4 6 9 ADJUSTING WAVEFORM SIZES When the cursor passes over the separating lines of the waveforms it changes to two arrows This indicates the possibility of dragging the separation line to change the height of the waveform Pull 534 740 MU2 REV 1 05 BitmedLab User s Manual the line up or down while left clicking to change the height of the waveform to the minimum or maximum height This functionality can be enabled or disabled from the Allow changes to the waveform size option in the Viewing tab in the Viewing options window NJ F tr Th 4 6 10 MODIFYING THE VIEWING ORDER OF WAVEFORMS Gotothe Analysis menu Viewing options orfrom the corresponding button of the viewing toolbar Enable the Montage tab In the Waveform window list select the waveform window where the changes to the channel viewing order will be made top or bottom To change the order of a waveform click on the waveform and without releasing the left click drag it to the new position Release the left click EEG 1 EEG 5 When you have finished adjusting the order of the wavefor
57. EV 1 05 BitmedLab User s Manual The results provided by the Automatic Analysis of Sleep Stages should not be used as the sole criterion for medical diagnosis or patient treatment The results must be supervised and reviewed by medical personnel with adequate training Choose the Automatic stage analysis option in the Analysis menu The program will ask you to confirm deletion of all the stages currently marked It will then request the channels to be used for the analysis It will be necessary to have an EEG signal and two EOG signals available Click on Accept to start the analysis Selection of EEG and EOG channels Select the EEG channel and the two EOG channels that you want to use in the automatic stage analysis EEG channel Ch amp EEG C3 42 v EOG channel Ch4 EOGLOC ChS EOG ROC Manual marking of sleep stages BitmedLab has two different ways of marking sleep stages manually First stage marking method In Tools gt Options enable the Genera tab and make sure the Advance epoch when stage is entered is disabled Close the window Place the cursor at the beginning of the test Enter the stage corresponding to the first epoch To do so use the corresponding button in the s eep toolbar or the key associated with the stage The software will introduce a mark from the beginning of the test to the end onooffoos Oh15m00s Oh30m00s 0 45 00 lt Lights 5 stages Use
58. EXEA SYSTEMS 22 2 3 1 WINDOWS emer rer errr MA 20 2 3 2 WINDOWS VISTA WINDOWS 7 AND WINDOWS 8 24 2 4 INSTALLING THE BLUETOOTH MODULE SLEEP amp GO SYSTEMS HU 28 3 USING THE PROGAM WITH THE SCREEN amp GO AND SLEEP amp GO SYSTEMS m 29 3 1 FIRST 6 5 29 3 1 1 STARTING UP THE SLEEPLAB MODULE 29 3 1 2 REGISTERING THE SCREEN amp GO SLEEP amp GO IN THE SOFTWARE 3 1 3 ENTERING USER DATA nnne 32 3 1 4 ENTERING THE SLEEP amp GO DATE AND TIME 33 3 1 5 DELETING STUDIES FROM THE SLEEP amp GO MEMORY ef o ERR I 34 3 2 HOME SCREEN OF THE PROGRAM THE SLEEPLAB MODULE WORKFLOW CHART 34 3 3 TEST SETTINGS cccccccecccccccceseeseeeceeeeeceeeeseseeeeeeesees 36 3 3 1 CREATING MODIFYING AND DELETING 534 740 MU2 e REV 1 05 BitmedLab User s Manual CONFIGURATIONS O 36 3 3 2 SETTING THE DEVICE DEFAULT CONFIGURATION USING BLUETOOTH ONLY amp 38 3 3 3 MANAGING THE DEVICE CONFIGURATIONS IN THE MEMORY n 40 3 4 PROGRAMMING AN AUTOMATIC TEST HQ 43 3 5 DOWNLOADING THE COMPLETED 46 3
59. G THE VIEWING ORDER OF THE WAVEFORMS FEDES ELENA KK 67 3 9 12 NAMING THE WAVEFORMS enne 68 3 9 13 WAVEFORM UNIITS eene nnne 69 3 9 14 HIDING OR SHOWING SEPARATION BETWEEN WAVEFORMS erre 70 3 9 15 ADDING AND DELETING WAVEFORMS 70 3 9 16 CHANGING THE SOFTWARE FILTERS 72 3 9 17 CHANGING THE SIGNAL WAVEFORM COLOR 72 3 9 18 MODIFYING WAVEFORM 5 73 3 9 19 DISPLAYING THE VALUES OVER THE WAVEFORM 74 3 9 20 NUMERICAL VALUES CURSOR SEES 75 3 9 21 nnne nennt nn 76 3 9 22 TYPES OF EVENTS enne nnns 78 3 9 23 AUTOMATIC ANALYSIS OF SLEEP EVENTS 80 3 9 24 MODIFYING THE OPTIONS FOR AUTOMATIC ANALYSIS OF SLEEP EVENTS eene 82 3 9 25 MANUAL MARKING OF SLEEP 83 3 9 26 WORKING WITH EVENTS 85 3 9 27 CALCULATING THE 89 3 9 28 PRINTING 3 10 GENERATING 91 3 10 1 GENERATING A m 92 3 10 2 PRINTING A REPORT m M 93 3 10 3 SAVING A REPORT eene 93 3 10 4 CHOOSING THE REPORT 94 3 10 5 GENERATING AND MODIFYING REPORT VENUE ETETE
60. ING THE VISIBLE FREQUENCY IN THE MAP The frequency being viewed in the map is shown at the top left of the graph To change it double click on the desired frequency in the power frequency graph on the right The frequency can also be changed from Viewing options Go to Analysis gt Viewing options Enable Power frequency map In the default Frequency text box enter the frequency that you wish to see in the map Click on Accept to apply the changes 7 3 CHANGING THE POWER FREQUENCY MAP OPTIONS Open Viewing options from the Analysis menu Viewing options Enable Power frequency map Enable See frequency bands to group the frequencies in characteristic band alpha beta delta theta Enable See background image to show a brain image in the map headers Use See electrode sites to show or hide the names and position of the electrodes selected in the map view Click on Accept to close Viewing options and apply the changes 534 740 MU2 REV 1 05 qe o1eA 3Jog enue A 6 1281 User s Manual Software BitmedLab BitmedLab User s Manual View settings Configurations Montage Test Traces Power frequency time Power frequency map Video Visualization settings C Show frequency bands Show background image C Show electrode location Default frequency 5 0 Hz 534 740 MU2 e REV 1 05 BitmedLab User s Manual ANNEX 1 APPLICABLE STANDARDS
61. J aifios pressure sioa thermo E Thoraac effort effort LJ Puke rate poz Puke nieve Finally a summary of the default configuration for the device will 534 740 MU2 REV 1 05 qe o1eA 3Jog Tenuey 6 1281 User s Manual Software BitmedLab BitmedLab User s Manual be shown Make sure that Bluetooth communication is enabled in your device and click on Finish The following configuration will be set to be used with all new manual started tests Configuration SIMPLE P Airfiow pressure transd 50Hz Airflow thermocouple 10Hz Thoracic effort band 10Hz Abdominal effort band 10Hz Movement Auxiliary 50Hz Snoring 250Hz Body position 1Hz Activity 25Hz CPAP pressure 1Hz Oxygen saturation 1Hz Pulse rate 1Hz Pulse wave 75Hz Pulseoximetry quality 1Hz Event marker 1Hz Programming method Bluetooth 3 3 3 MANAGING THE DEVICE CONFIGURATIONS IN THE MEMORY CARD Click on Device configurations in the home screen Each device test setting is associated with a Sleep amp Go system by means of a specific serial number The first step in the wizard is to choose the device that you want to establish the configurations for Click on Next 534 740 MU2 REV 1 05 BitmedLab User s Manual Device Select the polygraph to be configured Device leep amp Go B model S N 3 In the following screen choose
62. Lab User s Manual Specify the hour and minute of the test to go to in the box that appears Go to instant fe Move to instant 2 hours 10 minutes Click on Accept for the program to automatically go to the indicated instant Using the browsing marks If there is a place in the test of special interest that you wish to refer to in the future a browsing mark can be inserted at that place from the Analysis menu gt Insert browsing mark or by pressing on the Ctrl M key combination The mark appears as an upside down red triangle on the time scale 0100 L OhOO To return to the same point again simply go again to Analysis gt Browse to browsing mark or press on the Ctrl N key combination 3 9 7 ADJUSTING TIME ON THE SCREEN The time scale at the top of the waveform window shows the test time and the size of the epoch The size of the epoch also appears on the status bar Adjust the time on the screen with keys and and icons veg Use the and keys to multiply or divide the size of the epoch by two This can also be done by using the toolbar icons T and M Specifying the number of seconds per epoch Open the Viewing options window from the Analysis menu gt Viewing options Enable the Viewing tab There are three text boxes under the Seconds per epoch tab to set the visible time range in each window top waveform window bottom waveform window trends window These adjustments can be
63. QUENCY SPECTRUM GRAPH The frequency spectrum graph shows the frequency contents of the selection in a given channel In the waveform window choose the part of the test from which you wish to obtain the frequency spectrum The contextual menu of the selection will appear Click on Frequency spectrum The program will ask for the channel for which to show the frequency spectrum Select the channel and click on Accept Selection of channel for FFT Select among the following visible channels the one from which you want to obtain its frequency spectrum M A new window will open with the frequency spectrum graph or the power spectral density The frequencies between 0 and 50 Hz will appear on the horizontal axis The power for each of the frequencies will appear on the vertical axis 534 740 MU2 REV 1 05 BitmedLab User s Manual 08D54D57 F 6A5 4A68 BA20 BCF6995EF4B2 XGP 2 Power spectral density C3 P3 1876 4 1689 1501 1313 Mz 1 126 0929 0 750 0 563 0375 phr 0188 0 000 j Mz 1 58 30Hz 4 SHz 90Hz 10 54 120Hz 13 5Hx 150Hz Frequency Hertzs 6 1 2 MODIFYING THE FREQUENCY SCALE Right click on any part of the graph and select Properties Export as text Settings In the Graph properties window select the range
64. Screen amp G Test 1002 Technician Susan Collins Date 21 02 2011 gv Start time 22 00 00 Ee Duration 8 hours 0 Choose the type of test to be performed You can modify one of the available device configurations or create a new one by clicking on the Edit PC configurations button The graph shows the channels that will be acquired green or not red depending on the setting chosen You can also edit a configuration in situ activating or deactivating channels by clicking the appropriate button If you also want to save the changes as a new configuration click the Save button and the program will ask for a name for the configuration 534 740 MU2 e REV 1 05 BitmedLab User s Manual Click on Next Hew scheduled test wizard t anfiguration Sele coon Configurations avalebks in the PC Scvancad edhon E pressure airos thermo E E effort Abdominal effort EJ Puke rate L Fuke weve If you have a Sleep amp Go system with a Bluetooth communication module the test can be programmed directly via Bluetooth Make sure that Sleep amp Go is switched on Bluetooth is enabled and choose option A via Bluetooth Click on Next If not remove the device memory card remember to switch off the device before removing the memory card insert it into the PC card reader and choose option A via the memory ca
65. TATUS PATIENT TEST START DATE TIME DURATION PATH Recorded Jones Adam 01 02 2011 13 52 13 0 h 00m 11192 168 0 1441BitmedLab tests BSE1C318 895E 46DB other hand Tests pending reports button is similar to the one above but in this case it lists the tests that have been 534 740 MU2 REV 1 05 BitmedLab User s Manual reviewed but for which a report has not yet been generated gt Pending tests to be reported total of 0 tests need to be reported STATUS PATIENT TEST START DATE TIME DURATION Reviewed Sanders Tom 10032 11 01 2011 12 00 42 08h 00m 11192 168 0 1441BitmedLab tests 773956CD D64B 478E Reviewed O Seal Sarah 10064 18 01 2011 16 59 57 05h 06m 1192 168 0 1441BitmedLab tests A39F72C7 203F 4C44 Reviewed Jones Adam 10035 01 02 2011 13 52 13 gt 08h 00m 11192 168 0 1441BitmedLab tests B8E1C318 895E 46DB CC These two functionalities make it easier for the user to find work that is still pending completion Double click on any of the tests to open them 3 7 IMPORTING AND EXPORTING TESTS Importing tests Select the patient to whom you want to add the test and right click the mouse on the Tests folder of the tree In the context menu select Import test Patient di 8 In the Import dialog box select the test file to be added using the Browse button and click on Import The test
66. THE REPORT EDITOR By default the report will appear in a window in SleepLab If you wish SleepLab can open the report automatically in MS Word which provides much better editing possibilities Take the following steps to change the report editor Go to the Tools menu gt Options Enable the Edit reports in MS Word in the General tab Click on Accept to close the window and save the changes 3 10 5 GENERATING AND MODIFYING REPORT TEMPLATES The program is provided with several different report templates designed for different types of tests However the user can generate new templates or customize the existing templates to adjust them to his needs The report templates are in the Templates folder of the BitmedLab software product line folder e g C Program Files Bitmed BitmedLab 1 0 Templates The report templates are in RTF format RTF is a universal file type for text formatting The WordPad program supplied with Windows or MS Word two common programs can work with this type of file Any of the templates saved in this folder can be used to generate a new report All that is required is to create a new template and save it in the Templates folder where it will be available for the generation of a new report The report templates are based on the use of a series of labels that are later interpreted by SleepLab to generate the reports For example if a line in the template is Name name pat the program will replace the
67. TheBitmedLab software has the CE Marking CE 0197 The CE mark is a statement that the BitmedLab software fulfills the guidelines established by the EU for medical devices The BitmedLab is manufactured by SIBEL and the software meets the following standards and regulations Recommendations National consensus document the apnea hypopnea syndrome SAHS Spanish Sleep Group GES September 2005 AASM Manual for the Scoring of Sleep and Associated Events 2007 European Directive 93 42 EEC e CE marking Class Software e EN 62304 2006 AC 2008 Medical device software Software life cycle processes Usability e EN 62366 2008 Medical Devices Application of usability engineering to medical devices Safety e EN 60601 1 2006 AC 2010 Electrical safety 3rd edition Pulse oximetry e ISO 80601 2 61 Special requirements for basic safety and essential operation characteristics of pulse oximeters for medical use 534 740 MU2 e REV 1 05 1105 Tenueyy 6 1280 User s Manual Software BitmedLab BitmedLab User s Manual Symbology EN ISO 15223 1 2012 Symbols to be used with medical device labels labelling and information to be supplied e Information supplied by the manufacturer EN 1041 2008 Information supplied by the manufacturer of medical devices System quality Manufactured according to SIBEL S A Quality Manual which is compliant wit
68. USING THE PROGRAM WITH THE EXEA SYSTEMS 4 1 BEFORE STARTING 4 1 1 START THE PROGRAM There are two ways to start the program On the Windows Desktop double click on the S eepLab Pro icon In the Windows Start menu click on A programs go to the BitmedLab folder and click on the S eepLab Pro icon 4 1 2 REGISTERING THE EXEA IN THE SOFTWARE Before starting to use the eXea it must be registered in the BitmedLab software This procedure is required only once and ensures that your program is aware of the characteristics of your computer and those of the optional modules you have purchased Go to the Device menu Device manager Device manager Available devices Device Number Comm Serial number Status Automatic detection Make default device si D available devicefs Close Make sure the eXea system is running and connected to the PC Click on Automatic detection The software will detect the connected device A window will open to enter the password provided with your copy of the BitmedLab software 534 740 MU2 REV 1 05 BitmedLab User s Manual Device registration The Following device was detected exim Apnea SN 8006112901 The device must be registered within the program prior to be used Please enter the code supplied with the product Code Verify that the device has been registered in the software and that you can now work with it Device
69. User s Manual 7 BRAIN MAPPING RR n al b Ra OR RO RR BRUM 177 7 1 POWER FREQUENCY 177 7 2 CHANGING THE VISIBLE FREQUENCY IN THE 179 7 3 CHANGING THE POWER FREQUENCY MAP OPTIONS M 179 ANNEX 1 APPLICABLE STANDARDS 181 ANNEX 2 COMPLIANCE WITH THE DATA PROTECTION ACT DIRECTIVE 95 46 EC T 183 ANNEX 3 HOTKEYS n NER RUM 189 ANNEX 4 BITMEDLAB 190 ANNEX 5 SYMBOLS PONE nm es ANNEX 6 MAINTENANCE M 194 534 740 MU2 e REV 1 05 BitmedLab User s Manual 1 INTRODUCTION BitmedLab software has been designed and manufactured according to the SIBEL S A Quality Manual This Manual complies with quality standards EN 13485 and ISO 9001 as well as with European Medical Device Directive 93 42 EEC According to this directive this device is Class IIa 1 1 WHAT IS BITMEDLAB SOFTWARE BitmedLab software is the interface between the sleep study systems Bitmed Screen amp Go Bitmed Sleep amp Go Bitmed eXea PSG and the user via a PC BitmedLab provides review and analysis of holter and real time tests performed by Bitmed produc
70. XP Windows Vista Windows 7 and Windows 8 with an NTFS file structure Windows 9x systems or FAT file structures are not valid The PC administrator must create a unique and personalized identification for each user and activate authorization verification The operating system saves the passwords in an unintelligible way Access control The Operating System must be configured to control the access to data i e permit or deny access to data Likewise the PC administrator must set up the user account lock in order to impede reiterated attempts for unauthorized access Consult the manual of the operating system in order to set up these system access 534 740 MU2 REV 1 05 enue A 8281 User s Manual Software BitmedLab BitmedLab User s Manual controls Access register Accesses to the different databases are stored in one access register file Back up copies back up and recovery The user must at least once a week make back up copies of all data in order to guarantee full recovery of data in the case of a computer system failure In the case of the BitmedLab software full recovery of all database data is guaranteed if all of the application folder is saved as well as the folder where the tests and reports are stored by default the BitmedLab tests folder in My documents The back up copy must be stored at all times in a different place from where the software is used Operat
71. al data It is also advisable to activate the security audit in order to register valid and erroneous accesses to the system Access configuration and control File permissions The following step is to set up the access levels to the files which form the databases in relation to the previous users The database root be found in the BITMEDLAB data directory Inside there is a register file log BITMEDLAB log One possible configuration is to provide full access to the lt BITMEDLAB_HOME gt data folder to all users at least to the application users In any case the owner must always have read and write permissions on his database The rest of the users may have no permissions on that database for example It must be taken into account that in this situation the users may only access their database from the application On the log file BITMEDALAB log level it would be advisable for the users to only have read access so that the application could register the accesses to the different databases Permissions can be applied from Windows Explorer itself Simply access the Properties of the folder or file you wish to change permissions and select the Security tab From this tab you can select both the users who may access and the permissions total control read modification write etc of each user File audit We recommend the activation of the log file audit in order to register on the security event vie
72. also increase the space occupied by the file in the hard disk You can also choose the capture sampling frequency 11 22 or 44 KHz The higher the frequency the larger the resulting file will be 5 3 REVIEWING THE TEST When the video recording of a test has been completed or a test with video is opened the video window will be on the top right of the main window of the program The window can be hidden by clicking on the X and shown again from See Video If the numerical data cursor is enabled you can verify whether the video window is displaying the frame that corresponds to the time instant on which the cursor is placed 534 740 MU2 REV 1 05 BitmedLab User s Manual If the cursor is not enabled the video window will display the frame corresponding to the left end of the waveform window or the position of the pointer if a selection is being performed on the test The video will play automatically when you enable the play test function at the selected speed If any part of the test is deleted the corresponding video will not be deleted so it will cease to be synchronized with the biomedical signals 5 4 COMPRESSING THE VIDEO FILE AUTOMATICALLY AFTER COMPLETING THE TEST We recommend compressing the video file to significantly reduce its size If you want the program to compress the video automatically once the test has been completed choose the Compress video after completing the test option in the Video
73. ange the number of thickness pixels and click on Accept to apply the changes 534 740 MU2 REV 1 05 qe enue A 8281 User s Manual Software BitmedLab BitmedLab User s Manual Waveform settings Tid any property bo change the value fl Channel Sensor Snaiung Comments Color amping mie eee thick ne ses Low pacs Filler High pass fikar value mes value mn 5000 Lini s Show values over the wevefoin thickness Thickness af the signal 3 9 19 DISPLAYING THE VALUES OVER THE WAVEFORM Signal values can be displayed on the waveforms at regular intervals 100 0 86 7 73 3 60 0 100 0 94 93 Ch10 02 80 0 50 0 A _ ____ 400 Ch8 Pulse In the waveform window right click on the waveform to be changed and select the Channel properties option Enable the Display values over the signal option and click on Accept to apply the changes 534 740 MU2 REV 1 05 BitmedLab User s Manual Waveform settings any property bo change the value fl Channel Senso saluton Comments Color amping rate 1 E nwet raw efan Dui fl Hia pass fiber value mes 100 Minimum value ran 0 Show values
74. ange to be reported Ignore the first 0 minutes of the test Ignore the last 0 minutes of the test Create the report between two notes art Start of the test End End of the test In the next step choose the report template to be used Any new template generated will be added automatically to this list The user can also choose that the report open directly in the software or in the MS Word text editor if it is installed in the system 534 740 MU2 e REV 1 05 BitmedLab User s Manual 9 Open the report in SleepLab C Open the report in MS Word To generate a report when the test is open on the screen Choose Report in the See menu You can also use the button The Report creation wizard will be launched Follow the steps indicated previously If the test is edited after generating the report the report will have to be generated again for the changes to appear 3 10 2 PRINTING A REPORT With the report open and activated on the screen go to File gt Print Choose the printer printer properties printing interval and number of copies Click on Accept to start printing 3 10 3 SAVING A REPORT Go to File Save In Save as enter the name of the report file choose a folder to save it in and click on Save 534 740 MU2 REV 1 05 qe o1eA 3Jog Tenuey 6 1281 User s Manual Software BitmedLab BitmedLab User s Manual 3 10 4 CHOOSING
75. anual the test is completed they are transferred to the computer for review More than one holter mode test can be performed consecutively Afterwards when the data are downloaded to the PC they can be separated into the several different tests that were actually performed Capture of digital video is not available in tests performed in holter mode 4 5 1 CONSULTING DEVICE FREE TOTAL MEMORY Go to the Device menu Device manager In Device manager click on Show device free memory so see how many hours of storage are still available in the internal memory of the device If more memory is needed make sure all tests already performed have been downloaded to the PC and delete the information remaining in the memory Device manager Available devices Device Number Comm Serial number Status exim Apnea 14 USB 8006112901 Connecter Make default device gt m A R og Close 1 available devicefs To consult the total number of hours that the device can record in holter mode click on Show device total memory Device manager Available devices Device Number Comm Serial number Status exim Apnea 14 USB 8006112901 Connecter Make default device SH d HS A 1 available device s 534 740 MU2 REV 1 05 BitmedLab User s Manual 4 5 2 DELETING THE DEVICE MEMORY Before starting a test in holter mode it is recommendable to delete the contents in
76. applied separately to the top 534 740 MU2 REV 1 05 qe IIEMYO 950 User s Manual Software BitmedLab BitmedLab User s Manual waveform window the bottom waveform window or the trends window However the time range in the top waveform window cannot be longer than that of the bottom waveform window and the time range of the bottom waveform window cannot be longer than that of the trends window EJ Seconde epoch windo al Bottom wavefanre window 200 30 Zooming in on part of the test Left click on any part of the waveform where you wish to start the enlargement Without releasing the left click drag the mouse to the end of the part that you wish to enlarge A contextual menu will appear Select the Zoom selection option A Obstr apnea Central apnea Mixed apnea Desaturation Obstr hypop Central hypop Mixed hypop Snore Flow lim Zoom to selection Copy selection Delete Export to new file Export ASCI Unselect BHEB 8 Undoing the zoom on an area of the test To undo the zoom on an area of the test right click on a waveform Select Undo zoom selection in the menu that appears x BE Undo zoom to selection Trace settings View settings 534 740 MU2 REV 1 05 BitmedLab User s Manual Modifying the time referenc
77. ation that is to be imported The default configuration will be added to the list Deleting default configurations Go to the Analysis menu Viewing options Enable Default configurations In the list of default configurations choose the one you wish to delete Click on Delete configuration 534 740 MU2 REV 1 05 qerpounrg o1eA3Jog Tenuey sos User s Manual Software BitmedLab BitmedLab User s Manual 4 6 23 AUTOMATIC ANALYSIS OF SLEEP STAGES The program displays the sleep stage information in two different ways with the hypnogram 2h mons dhil nons leh or by means of a bar where the sleep stages are distinguished by a color code Artifacts dark green Waking magenta Stage 1 blue Stage 2 light green Stage 3 yellow REM black 5 stages MEN Depending on the time setting of the trends window the hypnogram or the stage bar will display the stage corresponding to the current epoch the trends behind and ahead of the current epoch the sleep structure of the entire night etc The template of the polysomnography report also shows the compete hynogram of the entire night Performing an automatic analysis is the sleep stages The automatic analysis of the sleep stages is only available if the corresponding license has been purchased 534 740 MU2 R
78. ch the entire epoch or a selection of epochs Browse to the epoch you wish to print and go to File gt Print Choose the printed items to include in the dialog For example a header with user data and or logo can be added Print settings Print options 7 Logo User data Patient data Traces Test and trace settings Sleep stages and events J lt lt 4 Print range Screen Full test Selected epochs Choose the printing range and click on Accept Direct printing The epoch on the screen can be printed directly by simply clicking on Direct printing the Standard toolbar The epoch will be 534 740 MU2 REV 1 05 BitmedLab User s Manual printed with the last settings used to print from File Print Choosing epochs for future printing While reviewing the test a series of epochs can be selected to be printed at the same time Choose the epoch on the screen by clicking on Select for printing epoch is selected and distinguished from unselected epochs by a purple mark in the time scale area 4 Oh32m30 33 00 E yyy When you have finished choosing the epochs go to File gt Print and when the Printing options window appears choose Selected epochs in Printing range Preliminary printing view Go to File gt Preliminary presentation Choose the items you wish to include in the prelimi
79. channel separating bar option Click on Accept to apply the changes Bi 0 0 0 BI NUNC NS ANE 7 0 9 406 A 1 0 0 AL 84 pV o 0 o 40 Sexe 9833 Bess gt 822 o0 4 6 13 ADDING AND DELETING WAVEFORMS Adding waveforms Go to the Analysis menu Viewing options Enable the Montage tab Choose the top or bottom waveform window that you wish to set up from the Waveform window list the inlet channels of the device appear on the right of the window the channels available will depend on the type of device Click on the ones you wish to add to the list of channels 534 740 MU2 REV 1 05 qe enue A 8281 User s Manual Software BitmedLab BitmedLab User s Manual Configurations Montage Test Traces Power frequency time Power frequency map Video Recording window upper w 15 01 8 32 Eosl Eog 02 14 23 26 dod cu C3 P3 14 1 Rae mr r2 E ca 2 64 14 2 28 Pa re 24 29 o 02 Chanrel Tm CE Pulso 33 C Bipolar D EEG Sa02 34 Reference Avg rel 3 DC DC1 ece Configurations Montage Traces Power frequency time Power frequency map Video Recording window upper T3 16 18 T3 Eogl
80. d for the software to apply it automatically to all new tests The default configurations are managed from the Default configurations tab in Viewing options The default configuration applied to the test can also be changed from the montage bar Configurations Montage Test Traces Power frequency time Power frequency map Video CPAP titration Load configuration Polaraphy Polsomnography Save current configuration Delete configuration Set as default Import configuration Export configuration Saving a default configuration Once the test has been set up to your liking go to Analysis Viewing options Enable Default configurations Click on Save current configuration The program will request a name for the default configuration Enter the name and click on Accept If there is already a configuration with the same name the program will request confirmation to overwrite it 534 740 MU2 REV 1 05 qe o1eA 3Jos enue A 6 1280 User s Manual Software BitmedLab BitmedLab User s Manual Enter a name for this configuration Loading and Applying default configurations from Viewing options Go to the Analysis menu Viewing options Enable Default configurations In the list of available configurations choose the one you wish to apply Click on Read configuration Click on Accept to apply the changes Loading and applying default configurations from
81. d then click the mouse in the place where the event starts The program inserts a predetermined duration event Use the event marking toolbar Choose the type of event that you wish to mark Ae DJ Gs Q3 10 G3 Gd a elg The cursor changes to an arrow with the sign Unless you click again on the event type icon all the events that are marked will be of the same type 534 740 MU2 REV 1 05 BitmedLab User s Manual Do not release the left click and select the part of the test where you wish to mark the event Release the left click to mark the event 3 9 26 WORKING WITH EVENTS Modifying the default duration for events inserted with the keypad Open the window Tools gt Options gt Event types Choose the event type you wish to customize and click on Properties Enter the desired duration with all the occurrences of the event entered with the keypad in the text box Default duration of events entered with the keypad Click on Accept and close the Event types window Changing the color of the event marks Open the window Tools gt Options gt Event types Choose the event type you wish to customize and click on Properties Click on the Co or section and choose the desired color for the mark Properties of the event type Apnea abstr over Specific charriel Eharna w Group cf waveforms Default duration for keyboard heted events seconds C
82. deo capture A video viewing window will appear on the top right of the screen The video is acquired at the same time as the signal data Once video acquisition has started it can be paused and resumed at any time which will also pause and resume the test recording To do so click on Pause resume direct communication Remember 534 740 MU2 REV 1 05 21e 3Jogs enue A 5 28 User s Manual Software BitmedLab BitmedLab User s Manual that when the recording is paused you can move freely through the test acquired up to that time although the video will not synchronize with the time instant that is being viewed in the waveform window If on the other hand you stop the recording using Stop direct communication you will not be able to add any more data to the test but the video will synchronize with the time instant indicated by the waveform window 5 2 MODIFYING THE CAPTURE PROPERTIES The audio and video capture properties can be changed from the Video tab in Viewing options The capture properties can only be changed before starting the test Frames per second the number of video frames that will be captured per second Remember that a high rate per second will generate a much larger file which may reach several gigabytes in long tests For example a test with 9 hours of compressed video at a rate of 5 frames second occupies approximately 600 Megabytes Controls these are used to change
83. different views Reference of the time scale to the instant 00h 00m 00s the time 534 740 MU2 REV 1 05 BitmedLab User s Manual line begins at instant O Reference of the time scale to the time the test is performed the time line begins at the instant the test performance is started OhOO mods ohoo 05 T5 A1 11h38m55s 11h38mD0s E Changing these time baselines does not affect the test performance time data Go to Options menu Viewing options and enable the Waveforms tab In the Time references box choose Reference of the time scale to the instant 00h 00m 00s or Reference of the time scale to the time the test is performed depending on which you prefer Click on Accept to apply the changes 4 6 7 NOTES The user can enter notes throughout the test for important observations This option can be very useful during a real time test if the technician wishes to take down visual observations of the patient restless moves wakes up etc or to take down changes in CPAP application drug administration and so on ALI the notes will appear later in the test report along with the instant when they were entered The program enters a note automatically each time a real time or holter recording is performed A note is also inserted each time user events marker pulsing occurs These notes are shown on the time scale of the waveform window 534 740 MU2 REV 1 05 21e 3jogs enue
84. e JA 6 1280 User s Manual Software BitmedLab BitmedLab User s Manual click on Accept to apply the changes to the test 3 9 12 NAMING THE WAVEFORMS Changing the waveform name display from the Viewing options window Open the Viewing options window from the Viewing toolbar button or from Analysis menu Viewing options Enable the Viewing tab Four different waveform name displays are available in the Name section of the waveforms Detailed this includes the full name of the sensor and its description Brief this shows only the abbreviated name of the sensor or the name of the electrode if it is defined Off channel this is similar to the previous one but shows the name to the left of the channel and hides the scale No description this hides all the text on the waveforms When you are finished click on Accept to apply the changes to test 534 740 MU2 REV 1 05 BitmedLab User s Manual Using the keypad to change the display of the waveform names The waveform name display can also be changed by using the keypad Use the C key to scroll through the four display options 3 9 13 WAVEFORM UNITS Channels measure physical quantities such as pulse rate or oxygen saturation Units are shown in the name of each waveform You can change the units of waveforms in the following way Open the Waveform settings by right clicking the mouse on the channel to be changed and
85. e from the patient list and click on the Delete patient button Confirm that you wish to delete the patient and associated tests 3 6 2 ASSOCIATING DOCUMENTS TO A PATIENT Select the patient and right click on the Patient tree documents folder Select the Associate document option Click on the Browse button in the Associate file window and choose the file that you wish to associate with the patient 534 740 MU2 REV 1 05 qe enue A 8281 User s Manual Software BitmedLab BitmedLab User s Manual Link file Select the document being linked to the patient Click on Associate and confirm that the file has been associated with the patient You can open or delete the association by clicking on the document icon H Tests Cj Documents Ls radiography bmp 3 6 3 SEARCHING IN THE DATABASE Search text field can be used to filter the results shown depending on the text that is entered Filtering can be applied to multiple data of both patients and tests last name name patient number insurance company medical record test number doctor of reference test date etc 3 6 4 TESTS PENDING REVIEW OR REPORT The Tests pending review button displays a window with the list of all the tests that have been downloaded to the PC and have yet to be reviewed S Pending tests to be reviewed xX A total of 4 tests need to be reviewed S
86. e is generated in the Screen amp Go Sleep amp Go memory card This file stores all the biomedical data compiled by the device When the test is transferred to the PC these files are automatically deleted However you may want to delete the files from the memory card To do so insert the card in the card reader of your PC and delete the files with DAT extension from Windows explorer Be sure to switch off Screen amp Go Sleep amp Go before removing the memory card You can also delete all the test files using the BitmedLab software Click on the Delete memory option of the Polygraph menu Confirm deletion of all the tests stored in your Sleep amp Go memory card The memory card test deletion option is only available from BitmedLab software in Sleep amp Go systems equipped with the Bluetooth communication module Before deleting the contents of the memory card make sure that all test that you are interested in keeping have been downloaded to the PC The deletion procedure will eliminate all the tests stored in the memory card The user will not be able to choose which tests to delete and which tests not to delete 3 2 HOME SCREEN OF THE PROGRAM THE SLEEPLAB MODULE WORKFLOW CHART The BitmedLab software home screen has been designed to facilitate the workflow of the Sleep Disorders Unit as much as possible Only the most common tasks are shown and these can be accessed by the following buttons Device configuration
87. enabled at a given moment There are three groups of event types simple intermediate and advanced each of which enables certain types of events as seen in detail in the table below 534 740 MU2 REV 1 05 BitmedLab User s Manual Simple Intermediate Advanced Obstructive apnea Mixed apnea Hypopnea Desaturation Snoring EE EN OC BO Flow limitation Limb movement PLM Regular breathing Cheyne Stokes breathing o E EN E OBI Hee Undetermined breathing event Arousal Movement arousal RERA Tachycardia Bradycardia Oo EN EM o BE Bee O Bruxism Select a group of event types depending on the type of test to be performed For example the simp e group may be enough for a screening test while the advanced group may be the proper option for a cardiorespiratory polygraph Only one group of event types can be enabled at the same time in the program In other words if the simp e group of event types is enabled and a test is opened with tachycardias marked the latter will not appear However if the group is changed to advanced the tachycardias will be seen perfectly Take the following steps to change the group of event types Go to the Tools menu gt Options Choose the Event types tab Choose the group you wish to use from the list of Group of event types 534 740 MU2 e REV 1 05 qe enue A
88. enu gt Viewing options Open the Viewing tab and enable or disable the View separating bar between waveforms option Click on Accept to apply the changes Z NU N NJ TU LS VS 406 2343 1 703 0 4920 84 184 0 y 492 0 100 0 40 86 600 150 3 9 15 ADDING AND DELETING WAVEFORMS Adding waveforms Go to the Analysis menu Viewing options 534 740 MU2 REV 1 05 BitmedLab User s Manual Enable the Montage tab and select waveform view in the Waveform window list top or bottom that you wish to set up All the inlet channels to the device appear on the right side of the window Click on the ones you wish to add to the list of channels Viewing options 4 Montage Dispiay iden Lurrent montage Avnilatle channels Montage ut Aiow Shoring CRAP Wavelorm Thoiahic P Abcomnel themmacauale Thoracic eto band Thoracoabderrinal sum hdomia band nong Bady ___ 5212 Delele Puke tale When all the desired channels have been added click on Accept to close the window and apply the changes Deleting waveforms Go to the Analysis menu gt Viewing options Enable the Montage tab and select the view you wish to set up from the Waveform window list Choose the visible waveforms that you wish to delete from the wavef
89. er s Manual Start all the tests in signal test mode For any new real time recording to start automatically in the signal test mode take the following steps Go to the Tools menu gt Options In the Genera tab enable the option Start tests in signal test mode Click on Accept to apply the changes 4 4 6 USING THE TIMER IN REAL TIME TESTS The software has a timer that can be used to time the various events or parts of a test For example the user can control the time during which the patient should hyperventilate according to the protocol being used Whenthetimerislaunched a note reading CR START is automatically inserted in the test Likewise when the timer is stopped a note reading CR END is inserted CHRSTART 1 1 1 The timer appears on the right of the status bar and can only be used while recording is being acquired in real time 00 01 13 Starting Stopping the timer Press the SPACE key to start the timer count Press the SPACE key again to stop the timer The timer can be started and stopped as many times as you wish during the test 4 5 PERFORMING TESTS IN HOLTER MODE A test in holter mode is a test during which the Bitmed eXea system is not connected to the computer while the test is being performed The data are stored in the internal memory of the device and once 534 740 MU2 REV 1 05 qerpounrg o1eA 3Jog enue A 51981 User s Manual Software BitmedLab BitmedLab User s M
90. es The program has two ways to reference time in the various windows Reference of the time scale to the instant 00h 00m 00s the time line begins at instant O Reference of the time scale to the time the test is performed the time line begins at the time the test recording is started 0100 003 0100 303 120 05 19h34m00s 19h34m30s 120 0s Changing these time baselines does not affect the test performance time data Go to Analysis menu Viewing options and enable the Viewing tab Inthe Reference time section selectthe instant option 00h 00m 00s or the test performance time option depending on preferences Click on Accept to apply the changes 3 9 8 NOTES The user can enter notes throughout the test for important observations This option can be very useful during performance of the tests in real time to record visual observations regarding the if the patient is restless moves or wakes up etc or to record changes in the application of the CPAP drug administration etc the notes will appear afterwards in the test report alongside the instant when they were entered The program enters a note automatically each time a real time or holter recording is performed A note is also inserted each time user events marker pulsing occurs 534 740 MU2 REV 1 05 21e 3Jogs enue A 5 281 User s Manual Software BitmedLab BitmedLab User s Manual These notes are shown on the time
91. es Power frequency time Power frequency map Video Video properties 01 A Adquiie video Framer per second 1 0 Video capture device HIF Camera JPEG M PEG v Source m swe Audio properties C3 A Sampling Adquiie audio Audio device propetties Mono OB bits 11kHz 3 Stereo 16 bits 22kHz Audio capture device Realtek ACS Audio Fz CZA Save video Save the video file with the same name than Ihe recarding file Pz A O Ask me for the video He name before the recording slarts Preview review Preview Compression C Compiess the video fle when stop the recording j Enable Acquire video and select the name of the video capture card from the list of Video capture devices This list includes all the devices installed in the system capable of capturing video If you also wish to acquire audio enable Acquire audio As in the point above select the audio device from the corresponding list Enable the Ask me for the file name before starting recording option if you want the program to request a name for the file that will store the video at the beginning of the test recording If not the video file will have the same name as the recording but with the extension AVI and it will be saved in the same folder we recommend this option Use Preview to preview the video source currently selected in Previewing Click on Accept to start the test and vi
92. est To stop playing the test click on the Stop playing test button LI 534 740 MU2 REV 1 05 enue A 5 281 User s Manual Software BitmedLab BitmedLab User s Manual The difference between this button and the pause button is that when play is resumed it does so from the beginning of the epoch on the screen 3 9 6 SCROLLING THROUGH THE TEST Using the time bar The time bar allows the user to scroll through the test quickly Simply drag the scroll bar to move to another moment in the test Scrolling will take place in the window that is active at the time framed in yellow The current time and the total duration of the test is shown to the right of the scroll bar i18 wcwm ho Using the keypad The following keys are used to scroll through the test Start moves to the beginning of the test End moves to the end of the test Page down goes to the next epoch Page up goes to the previous epoch Left arrow goes back a short time in the epoch Right arrow goes forward a short time the epoch Forward half epoch Use the Forward half epoch button sdfsdf of the View toolbar or the Tab tabulator key to move forward half a epoch This option is useful for a clear view of events that occur at the limit between two consecutive epochs Using the Go to instant option Open the Analysis menu Go to instant 534 740 MU2 REV 1 05 Bitmed
93. eview test 25 4 6 2 FULL SCREEN MODE Use the full screen mode to maximize the available screen space to review the test The Windows task bar the title bar of the application and the toolbars will all disappear in this mode display them by going to the View menu Toolbars and coupling windows Go to View Full screen to enter the full screen mode To exit the full screen mode click the Close full screen floating button or go to the View menu gt Full screen 4 6 3 DOUBLE WAVEFORM WINDOW The waveform window can be divided into two parts during review The two waveform windows can be set up with different time scales In addition each waveform can be displayed or hidden in either of the windows Therefore for example in a sleep study the top window can be configured to view the fast channels and the bottom window to display the slow channels each with a different time range 534 740 MU2 REV 1 05 qe o1eA 3Jog enue A 7950 User s Manual Software BitmedLab BitmedLab User s Manual The time scale used in the top window is shown in violet over the time scale used in the bottom window 4 6 4 PLAYING THE TEST Any of the tests can be played automatically at different speeds Place the cursor at the beginning of the part of the test that you wish to play This can be at the very beginning or any other moment of the test Click on the Start playing test button on the play toolbar
94. ft arrow Move half an epoch forward Tab Change the way text of event marks is displayed E 534 740 MU2 REV 1 05 qe enue A Sosy User s Manual Software BitmedLab BitmedLab User s Manual ANNEX 4 BITMEDLAB SPECIFICATIONS Useful life Available data or graphs in the report Supported events events supported by the automatic analysis module are marked with Pulse rate SpO and body position summary graphs Sleep events summary graph Time in each body position Mean and maximum duration for each sleep event Apnea hypopnea index Indexes of all sleep events Indexes of sleep events by body position Pulse rate and SpO histograms PTT increases decreases mean minimum and maximum PTT values Hypnogram Sleep stages stats Apnea obstructive central and mixed Hypopnea Desaturation Limb movement Periodic limb movement PLM Snore Arousal Movement arousal Respiratory effort related arousal RERA Flow limitation Bruxism Periodic respiration Cheyne Stokes respiration Undetermined respiratory event Tachycardia Bradycardia 534 740 MU2 REV 1 05 BitmedLab User s Manual Operating MS Windows system XP Vista or 7 CPU Intel Pentium Dual core 4 AMD Athlon processor RAM memory 1024 Mb 2048 Mb Free HD space 100 Mb Several gigabytes are needed to acquire synchronized digital video USB 1 1 ports Screen a
95. ged and select the Channel properties option The Channel properties window will open There is a Color box with the current color of the signal waveform Click on the color box to 534 740 MU2 REV 1 05 BitmedLab User s Manual open the color selection dialog and choose the new color for the signal waveform Click on Accept when you are done Waveform Tid an any property bo change the value ettins mping rate Saf eee nies Inveit Low Filler Hia pass fikar value mes 000 Minimum value rmn 5000 Lini s Show values over the Dolor Color of tha signal maw efam 3 9 18 MODIFYING WAVEFORM THICKNESS The on screen waveform thickness can be modified for all the channels at the same time or only for one specific channel Modifying the thickness of all the waveforms Open the Viewing options window from the Analysis menu and verify that the Apply the same thickness to all the waveforms option is selected Modify the Waveform thickness option and click on Accept to apply the changes Modifying the thickness of a single waveform Verify that the Apply the same thickness to all the waveforms option is not selected in the Analysis window Viewing options Then open the properties of the waveform you wish to modify by right clicking on it and select the Channel properties option in the contextual menu Ch
96. h EN ISO 13485 2012 2012 and EN ISO 9001 2008 Risk Management EN ISO 14971 2012 The user should follow e Data protection Data Protection Law and Directive 95 46 EC 534 740 MU2 REV 1 05 BitmedLab User s Manual ANNEX 2 COMPLIANCE WITH THE DATA PROTECTION ACT DIRECTIVE 95 46 EC This section aims to facilitate the compliance of current legislation referring to data protection by the user with the use of this software Consult your local translation of the 95 46 EC directive A brief description of the fundamental points of the aforementioned legislation is given as well as what needs to be done with the BitmedLab Software and or the operating system in order to comply with the requirements described in the aforementioned law According to current legislation the software user is solely responsible for the storage and treatment of their patient data in accordance with the law Observance of the recommendations included in this section does not guarantee in any case the full adaptation of user activity to the standards relating to data protection Requirements which specifically affect the use of the BitmedLab Software Identification and Authentication The processes for user identification and authentication for use of the BitmedLab are performed by the PC s operating system Therefore only Windows Operating Systems allowing these processes in a secure way are valid i e Windows
97. hanged from Channel properties as seen in the previous section 4 6 18 CREATING EEG EOG DERIVATIONS To create an EEG or EOG derivation you will need two reference 534 740 MU2 e REV 1 05 BitmedLab User s Manual channels single pole Some devices such as Bitmed eXea PSG series 4 and 5 or Bitmed eXea Ultra have hardware reference channels In other cases you may want to convert differential channels bipolar into reference channels single pole by means of a bridge between channels refer to the user s manual of the device for more information on this procedure If so the hardware has to know that the channel has been converted to a reference channel Setting up a differential channel as a reference channel Go to the Analysis menu Viewing options Enable the Montage tab Assuming that the channel is already in the list of visible channels double click on it or select it and click on Properties The Channel properties window will open Choose the signal type EEG or EOG for the channel to display from the Signal type list Enable the option Reference Wavetorm settings lnpulchannet 3 2 Monopol Bipolar e EEG Commerits E Sampling rale 100 Hz C signal values over Lacal Low hter ISHz High pass File ow Netch iter Input range Max 7122 value 7123 Urita
98. he field header are the buttons used to add change or delete a patient or to show the patient s associated documents There is also a text box to browse through the database The area on the right is used to show the tests associated with the patient that has been selected The information is updated every time a different patient is selected Each test includes the start date and time duration and status of the test The buttons at the top are used to review tests generate new tests in real time or to download tests to the computer import export etc Lastly there is information concerning the test pending review or 534 740 MU2 e REV 1 05 BitmedLab User s Manual reporting as well as buttons to access these quickly Fatieres Test Fite bir ae Cy 7 X PATIENT SURNAME STATUS TEST START DATE TIME OURATI Path B54123698 Reynolds Reviewed POLOUI23 21 06 2010 23 00 00 OER 00m 4255741 Be CE547E9201 Ramirez FBAB258953 Welcop lt gt t D tels pending review T tests pending repart 4 2 1 ADDING MODIFYING AND DELETING PATIENTS Adding a new patient Have the database window open and click on the New patient button 5 Fill in the patient data in the Patient window and click on Accept 534 740 MU2 REV 1 05 qe enue A 8281 User s Manual Software BitmedLab BitmedLab User s Manual Patient
99. ile Output File Choose the video file to compress in Input file Choose the name for the compressed video file in Output file You can choose the same file if you wish Click on Compress to start compression 5 7 CHANGING THE VIDEO FILE ASSOCIATED WITH A TEST This option only appears once test acquisition has been completed and allows the user to associate a video file other than the original 534 740 MU2 REV 1 05 BitmedLab User s Manual one This is useful when the test file is moved from one folder to another or to another computer and the location of the video file does not coincide with the original Open Viewing options from Analysis gt Viewing options Enable the Video tab Click on Video file associated with the test to choose the video file you wish to associate with the test Click on Accept to apply the changes 534 740 MU2 e REV 1 05 qe enue A 8281 User s Manual Software BitmedLab BitmedLab User s Manual 6 FREQUENTIAL ANALYSIS TOOLS The optional frequential analysis module provides the user with two working tools based on Fourier Fast Transform FFT the frequency spectrum graph also known as spectral density and the power frequency time graph The functions describe throughout this chapter are only available if you have purchased the frequential analysis license 6 1 FREQUENCY SPECTRUM GRAPH 6 1 1 DISPLAYING THE FRE
100. ile choose a folder to save it in and click on Save 534 740 MU2 REV 1 05 qe enue A 8281 User s Manual Software BitmedLab BitmedLab User s Manual 4 7 4 CHOOSING THE REPORT EDITOR By default the report will appear in a window in BitmedLab If you wish BitmedLab can open the report automatically in MS Word which provides much better editing possibilities Take the following steps to change the report editor Go to the Tools menu gt Options Enable the Edit reports in MS Word in the General tab Click on Accept to close the window and save the changes 4 7 5 GENERATING AND MODIFYING REPORT TEMPLATES The program is provided with several different report templates designed for different types of tests However the user can generate new templates or customize the existing templates to adjust them to his needs The report templates are in the Templates folder of the BitmedLab folder e g C Program Files Bitmed BitmedLab 1 0 Templates The report templates are in RTF format RTF is a universal file type for text formatting The WordPad program supplied with Windows or MS Word two common programs can work with this type of file the templates saved in this folder will appear as templates that can be selected in the Se ect report type window that is required is to create a new template and save it in the Templates folder where it will be available to generate a new re
101. incide with the real situation 305 If you wish to toggle between seconds and mmy s Go to Tools gt Options Enable the General tab Choose the desired option in the list of Epoch units seconds or mm s Zooming in on part of the test Left click on any of the channels where you wish to start the enlargement Without releasing the left click drag the mouse to the end of the part that you wish to enlarge 534 740 MU2 e REV 1 05 qe enue A 8281 User s Manual Software BitmedLab BitmedLab User s Manual apnea Central apnea Mixed apnea Arousal Desaturation Movement Snore RERA Flow lim Mow ara Tachycardia Bradycardia Bruxism Periodic brea Cheyne Stokes brea Undetermined resp event Zoom En selection Frequency spectrum Copy selection Delete 0 71 71 Export to new File 81 92 94 55 Export Unselect h15m us 0630 05 A contextual menu will appear Select the Zoom selection option Undoing the zoom on an area of the test To undo the zoom on an area of the test right click on any of the waveforms Select Undo zoom selection in the menu that appears LN d A Li Li lh Undo zoom to selection Trace settings View settings Modifying the time references The software provides the user with two ways to show the time in the
102. ing System Configuration On a Windows operating system level XP Vista 7 or 8 and for NTFS partitions it is possible to restrict the access to the different databases using the security characteristics of the file system Generally speaking the control of access to databases is covered by the following points e Configuration of identification authentication Each user that accesses the system must have a unique username and password whether a local user or a network user connecting to a domain The passwords must be changed epochically with a freely selected frequency and whilst a series of passwords remain valid they will be stored in an unintelligible Way User definition can be carried out from the Users and Passwords icon on the Control Panel Using the Advanced Administration button on the Advanced Options tab you can access the Local and Group Users configuration From the Users branch new users can be created or existing properties modified The access level of users can be set up in user properties on the Users tab of the Users and Passwords icon We recommend that users are not given Administrator access level In any event the 534 740 MU2 REV 1 05 BitmedLab User s Manual Administrator is the person responsible for ensuring that users use their identification in the ways determined both technically and by documentation as well as making them aware of their obligations in relation to the treatment of person
103. inue the test from the point at which the signal test had begun click again on the same button Start all the tests in signal test mode For starting automatically all the new real time recordings in the signal test mode perform the following steps Go to the Tools menu Options In the General tab enable the option Start tests in signal test mode Click on Accept to apply the changes 534 740 MU2 REV 1 05 BitmedLab User s Manual 3 9 REVIEWING THE TESTS 3 9 1 USER INTERFACE ELEMENTS DURING TEST REVIEWS The following illustration shows the SleepLab software module during a test review deL File Edit View Polygraph Analysis Tools Window Help LE OLET FR 1 9 4 2 3 02 2 C3 02 9 gt Am um Ols wem Q wes 0804 00 001 20 Press F1 for help 30 0 s Menu bar Standard toolbar used to access the home screen save the test and printing Test toolbar communication functions with Sleep amp Go during performance of the real time tests View toolbar changes in the time per epoch viewing options report generation etc Play toolbar allows playing the test at different speeds 534 740 MU2 REV 1 05 qe enue A 8281 User s Manual Software BitmedLab BitmedLab User s Manual Analysis toolbar contains tools for sleep event analysis Time toolbar provides a scroll bar to browse through the te
104. is installed by default C Program Files Bitmed BitmedLab x x and from now BITMEDLAB gt This file is created first time that the application is executed and cannot be deactivated The system administrator is responsible for the maintenance of said file with regard to size and the preparation of a monthly report where the epochic reviews carried out are analyzed and any problems detected are reported should there be any The log file saves for each line e User e Time and date of access e Database accessed e Action carried out on the database e Type of access authorized or denied e File path of database accessed e Reference of the register accessed 534 740 MU2 REV 1 05 BitmedLab User s Manual The format of each of the lines is the following USER YYYYMMDD HH MM SS BASE ACTION ACCESS PATH REFERENCE The actions to be registered are divided into e Action on the actual database itself open close delete etc e Action on the registers stored on the database insert consult delete etc In any case the register or access control log file must be kept for a minimum epoch of two years Below all actions registered on the log file are listed e Open DB Close DB e Select DB e Create DB e Delete DB Modify the access password Consult record Consult all records e Add record e Update record e Delete record e Export record
105. ist or specific location and click on Next Found New Hardware Wizard This wizard helps you install software for USB Serial Port If your hardware came with an installation CD lt gt or floppy disk insert it now What do you want the wizard to do Install the software automatically Recommended Install from a list or specific location Advanced Click Next to continue In the following window select Search for the best driver in these locations and Include this location in the search Choose the USB Drivers folder in the BitmedLab CD and click again on Next 534 740 MU2 REV 1 05 BitmedLab User s Manual Found New Hardware Wizard Please choose your search and installation options Na Search for the best driver in these locations Use the check boxes below to limit or expand the default search which includes local paths and removable media The best driver found will be installed C Search removable media floppy CD ROM Include this location in the search 100330 driver J Don t search will choose the driver to install Choose this option to select the device driver from a list Windows does not guarantee that the driver you choose will be the best match for your hardware Windows will start installing the driver Click on Next in the window that appears Found New Hardware Wizard Please wait while the wizard installs the
106. itmedLab User s Manual The device will be detected now by means of the memory card Check that the memory card is inserted in the card reader Click on Next to start the detection A window will open to enter the password provided with your copy of the BitmedLab software product line Enter the password and click on Accept The following device was detected SN 1 The device must be registered within the program prior to be used Please enter the code supplied with the product Code The wizard will detect Screen amp Go Sleep amp Go and present the compiled information Click on Finish 534 740 MU2 REV 1 05 qe enue A 8281 User s Manual Software BitmedLab BitmedLab User s Manual Note that the device has been registered in the software The device is now ready to be used Available devices Device Number of Bluetooth Serial number Automatic detection Sleep amp Go model 1 YES 3 1 available device s 3 1 3 ENTERING USER DATA BitmedLab lets you enter user data and an image with your logo These will appear in the header of printed documents and in the report generated for each test Click on Configuration in the Tools menu Open the User data tab and fill in the fields with the user data 534 740 MU2 REV 1 05 BitmedLab User s Manual Settings 4 y Programm settings
107. k when the event mark is in the desired position 534 740 MU2 REV 1 05 BitmedLab User s Manual Changing event duration Place the cursor over the left or right end of the event The cursor changes as shown in the illustration Obstructive apnea 15 0 8 0 p 12 582 Click and move the cursor to the left or right while maintaining the left click Release the left click when the event mark is in the desired position Changing event types Place the cursor over the event you wish to change and right click A menu will appear with all the event types defined in the application Obstructive apnea 8 0 8 0 D 12 60s SSS Obstructive Apnea Central Apnea Mixed Arousal Desaturation Movement Obstructive Central Mixed Snore Spike External trigger RERA Remove event Choose the type of event to assign to the event 534 740 MU2 REV 1 05 enue A 8281 User s Manual Software BitmedLab BitmedLab User s Manual Deleting events with the mouse Press the Control key The cursor changes to an arrow with the sign Do not release the Contro key and click on the event to deleted Deleting events from the event mark Place the cursor over the event you wish to delete and right click Choose the Delete event option in the conte
108. ke sure you save the test or changes made before turning off the PC Do not turn off the PC when performing a real time test Stop the real time test first Check if software updates are available Although the CDs can bear temperatures over 70 C the information stored could be lost if exposed to high temperatures for a long period of time eg at 70 C the information is kept for 2 000 hours The CD should be stored at a temperature of 25 C which guarantees more than 1 000 000 hours The recommended minimum duration for sleep studies to be reliably evaluated is 6 hours The CD should be cleaned gently with a cloth moistened with mild hand soapy water and wiped dry avoiding scratches on the CD Keep the CD into its package when not in use None of the results provided by the Automatic Analyses contained in the BitmedLab software product line should be used as the sole criterion for medical diagnosis or patient treatment This information should not be considered complete nor is it to be trusted for the prescription of individual treatment The user must understand that the results of the Automatic Analyses generated by the BitmedLab software product line are not exhaustive and must always be supervised and verified by medical personnel with adequate training In no case shall Sibel S A be responsible for any losses damages or expenses derived from incorrect use of the device the software or the computer devices operating sys
109. l Found New Hardware Wizard Please choose your search and installation options Na Search for the best driver in these locations Use the check boxes below to limit or expand the default search which includes local paths and removable media The best driver found will be installed C Search removable media floppy CD ROM Include this location in the search DAUSB Drivers 2 6 2 0_100330 driver Don t search will choose the driver to install Choose this option to select the device driver from a list Windows does not guarantee that the driver you choose will be the best match for your hardware Windows will start installing the driver Click on Next in the window that appears Found New Hardware Wizard Please wait while the wizard installs the software e Bitmed Device Setting a system restore point and backing up old files in case your system needs to be restored in the future Once the driver installation is completed click on Close 534 740 MU2 REV 1 05 qe enue A 8281 User s Manual Software BitmedLab BitmedLab User s Manual Found New Hardware Wizard Completing the Found New Hardware Wizard The wizard has finished installing the software for Bitmed Device Click Finish to close the wizard Finish The system will then detect a new device called Bitmed Virtual Port Choose the Install option from a l
110. late will appear in the list of available templates for the generation of reports 534 740 MU2 REV 1 05 21e 3Jogs enue A 5 281 User s Manual Software BitmedLab BitmedLab User s Manual 5 ACQUIRING DIGITAL VIDEO XGPVision is an optional module that allows the user to acquire synchronized digital video and audio in sleep studies The audio and video are stored in a file different than that of the test file in the same folder and with the same name but with an AVI extension The video acquisition process is a demanding process for the computer so video compression during capture is minimum This generates large files these can occupy several gigabytes and they will need to be compressed after acquisition in order to be saved alongside the test Video compression used an MPEG4 standard compressor that significantly reduces the size of the file Audio compression uses a standard MP3 Compression significantly reduces the size of the file without affecting the quality XGPVision is completely integrated into BitmedLab and is very easy to use The functions described throughout this chapter are only available if you have purchased the XGPVision license 5 1 ACQUIRING VIDEO DURING PERFORMANCE OF REAL TIME TESTS Start recording a new test in real time When you are in Viewing options select Video 534 740 MU2 REV 1 05 BitmedLab User s Manual Configurations Montage Test Trac
111. lick on Accept to apply the changes Hiding showing the event marks on the waveforms 534 740 MU2 e REV 1 05 qe enue A 8281 User s Manual Software BitmedLab BitmedLab User s Manual The events are marked with a color rectangle over the signal waveform The mark also includes the event type the time instant of the start of the event and its duration These marks can be shown or hidden by the user Open the Viewing options window from the Analysis menu and enable the Waveforms tab To hide the marks disable the option Show event marks on waveform Enable the option again to show the marks Click on Accept to close Viewing options and apply the changes Hiding showing the trends window The trend window displays a bar for each type of event The occurrence of each event is marked with a color rectangle on this bar The number of occurrences of each event type appears on the left of each bar These bars are normally used to get a general idea at a glance of the trend of events over a long epoch of the test or the complete test The trends window can be shown or hidden by clicking on the button of the Viewing bar by clicking on See gt Trends menu Moving events Place the cursor over the event to be moved The cursor changes as shown in the illustration Obstructive apnea S 0 8 0 D 12 68z Click on the event and drag it while left clicking Release the left clic
112. ls Options Event types Choose the event type you wish to customize and click on Properties Enter the desired duration with all the occurrences of the event entered with the keypad in the text box Default duration of events entered with the keypad 534 740 MU2 REV 1 05 BitmedLab User s Manual Click on Accept Close the Event types window Changing the color of the event marks Open the window Tools Options Event types Choose the event type you wish to customize and click on Properties Click on the Co or section and choose the desired color for the mark Properties of the event type Apnea abstr over charnel Channel Diop pF wave omes Edta Default duration For inserted events LN acconds Click on Accept to apply the changes Hiding showing the event marks on the waveforms The events are marked with a color rectangle over the signal waveform The mark also includes the event type the time instant of the start of the event and its duration These marks can be shown or hidden by the user Open Viewing options from the Analysis menu Enable the Waveforms tab To hide the marks disable the option See event marks on waveform To show the marks enable the option See event marks on waveform Click on Accept to close Viewing options and apply the changes 534 740 MU2 REV 1 05
113. manager Available devices Device Number Comm Serial number Status Automatic detection exim Apnea 14 USB 8006112901 Delete Properties Make default device 1 available device s 4 1 3 ENTERING USER DATA BitmedLab lets you enter user data and a logo These will appear in the header of printed documents and of the report generated for each test Go to the 6 menu gt Options Open the User data tab and fill in the fields of the form 534 740 MU2 REV 1 05 qe enue A 8281 User s Manual Software BitmedLab BitmedLab User s Manual 4 E Programm settings Customizable keys Event types User data Health center company Address ZIP code City Telephone E mail To select a logo click on the key of the Logotype field and choose your logo image The image must have been stored in a file with BMP format 4 2 MANAGING PATIENTS AND TESTS THE DATABASE The BitmedLab database provides easy management of all your patients and tests It can be accessed by clicking on the Database button of the Standard toolbar The database window is divided into two highly differentiated areas On the left is the list of patients showing the name last name and number of the patient The list can be ordered by any of these fields by clicking on the field header Over t
114. me test recording If you have the license of the XGPVision optional software module and wish to capture digital video enable the Video tab This tab will not appear if the XGPVision module is not available 534 740 MU2 e REV 1 05 qe enue A 8281 User s Manual Software BitmedLab BitmedLab User s Manual Configurations Montage Test Traces Power frequency time Power frequency map Video Video properties amp dquiie video Framer per second 10 Video capture device IF Camera JPEG M PEG Format Inputs Audio properties Sampling Adquiie audio Audio device propeities C Mono OB bits 11kHz Stereo 16 kits 22kHz Audio capture device Realtek ACI Audio 44kHz Save videa 9 Save the video file with the same name than Ihe 1ecarding Ask me forthe video before th ding slart z O sk me for the video name berore the recording sarts Preview Compression C Compiess the video fle when I stop the recording Set up the video and audio acquisition options according to your preferences You can find more information on video and audio acquisition further along in this manual Click on Accept to close Viewing options The software will ask you to choose the name to save the test with Choose the folder and the name you wish to save the new test with and click on Save The device will start acquisition of the bi
115. mp Go Sleep amp Go 2 if a Bluetooth module and card reader are used 1 Screen 1024 x 768 1280 x 1024 or resolution higher Synchronized Free PCI digital video Xpress slot capture Desktop PCs Free Xpress Card slot Laptops User defined Unlimited in the software up to 10 configurations Screen amp Go at the same time in the device and Sleep amp Go configurations Scheduled tests Unlimited in the software up to 5 scheduled tests at the same time in the device User defined Unlimited montages Stores patients data tests and reports Customizable on 5 6 7 8 9 10 15 20 30 60 120 300 screen time seconds or user defined 534 740 MU2 REV 1 05 enue A 8281 User s Manual Software BitmedLab BitmedLab User s Manual Filters Low pass filter 3 5 10 15 25 35 45 70 100 Hz High pass filter 0 1 0 5 1 2 10 Hz Environmental Transportation and storage see NOTE at the conditions for the end of table CD ROM Temperature 250C to 709 Relative humidity lt 93 without condensation Other features Annotations on the test Customizable channel amplitudes Customizable thickness of waveforms Values over the waveforms Trends window Customizable reports Digital video capture Spectral analysis module Sleep events detection module Sleep stages detection module It is recommended to store the CD ROM at 259C At this temperat
116. ms click on Accept to apply the changes to the test 534 740 MU2 REV 1 05 qe o1eA 3Jog enue A 5 1280 User s Manual Software BitmedLab BitmedLab User s Manual 4 6 11 NAMING THE WAVEFORMS Changing the waveform name display from the Viewing options window Open the Viewing options window from the Viewing toolbar button or from Analysis menu Viewing options Enable the Waveforms tab Four different waveform name displays are available in the Waveform description list Detailed this includes the channel number long name of the associated sensor and its description Brief this shows only the abbreviated name of the sensor or the name of the electrode if it is defined Off channel this is similar to the previous one but shows the title to the left of the waveform and hides the scale No description this hides all the text on the waveforms When you are finished click on Accept to apply the changes to the test 534 740 MU2 e REV 1 05 BitmedLab User s Manual Using the keypad to change the waveform name displays The waveform name displays can also be changed by using the keypad Use the C key to scroll through the four display options 4 6 12 HIDING OR SHOWING SEPARATION BETWEEN WAVEFORMS Open the Viewing options window from the Viewing toolbar button or from Analysis menu Viewing options Enable the Waveforms tab Enable or disable the See
117. n also be captured to improve patient monitoring In this case it is generated in the same folder where the xgp file is stored in a file with avi extension and the same name as the test file Capturing digital video involves a large amount of free space in the hard disk which determined by the resolution and the number of frames used for capturing 534 740 MU2 REV 1 05 21e 3jogs enue A 5 281 User s Manual Software BitmedLab BitmedLab User s Manual We recommend having at least 20 Gb free to perform a long sleep test Capture of digital video is not available in tests performed in holter mode 4 4 1 STARTING THE REAL TIME TEST The test is started in the program once the electrodes and sensors have been placed on the patient Choose the patient to whom the test is associated with in the database window If the patient is not in the database yet enter the patient data first Click on New real time test Ue If there is more than one device you are requested to indicate which device is going to be used to perform the test The Viewing options dialog box appears Enter the test settings options the sensors that are going to be used the screen viewing order filters epoch durations etc Though these data can be customized each time a new test is started it is more convenient to save all the parameters under a default configuration that can be then loaded directly or used by defaul
118. n entering notes can be completely customized to user preferences This is done by editing the notes txt text file in the application folder default X Program files Bitmed BitmedLab x x Remember to enter one note per line 3 9 9 ADJUSTING WAVEFORM RANGES Adjusting ranges with keys and or the mouse The simplest way to quickly adjust the range of a waveform is to place the cursor over the waveform to be changed and press the 1 and keys to increase or decrease the amplitude If you want to modify the range of more than a waveform at once then left double click on the waveforms that you wish to change the range of The background of the waveform will change color hoe ANS 534 740 MU2 REV 1 05 qe 1105 Tenueyy 6 1280 User s Manual Software BitmedLab BitmedLab User s Manual Use the 1 and keys to increase or decrease the range of the selected waveforms unii TWh The amplitude of any channel may also be increased or decreased by clicking on it and then pressing the and keys while holding the left mouse button Adjusting waveform ranges accurately Right click on the waveform to be changed and select the Channel setings option The Channel settings window will open Change the maximum and minimum values The possible maximum and minimum values are specified in brackets Waveform settings Click an any property bo change the value fl Cha
119. n the device manager via Start Control panel Hardware 534 740 MU2 REV 1 05 BitmedLab User s Manual and sound Device manager In Device manager locate the entry that corresponds to your device and double click on it File Action View 6 2 W7 PC gt 4M Computer xc Disk drives gt Me Display adapters 24 DVD CD ROM drives gt eld Floppy disk drives b Floppy drive controllers gt cg ATA ATAPI controllers n Mice and other pointing devices gt Mi Monitors gt i Network adapters 4 Other devices i eXim Apnea gt Portable Devices gt Ports COM amp LPT D Processors gt E Sound video and game controllers gt lt gt Storage controllers gt System devices p Universal Serial Bus controllers Choose the Driver tab and click on the Update driver button Driver Provider Unknown Driver Date Not available Driver Version Not available Digital Signer Not digitally signed Driver Details To view details about the driver files To update the driver software for this device the device fails after updating the driver roll back to the previously installed driver Disables the selected device Uninstall To uninstall the driver Advanced Roll Back Driver Click on Search for driver software on your computer 534 740 MU2 REV 1 05 qe
120. nary view This window also provides the option of obtaining a preliminary view of the entire test only the epoch viewed on the screen or the epochs selected for printing The preliminary view can be used to print what is being viewed on the screen 3 10 GENERATING REPORTS Once the doctor has reviewed the test he can issue a complete report with all the test data including statistical information of the sleep events that have been detected The software includes a series of default templates that can be used to generate reports The user can customize these templates or create new ones as described below 534 740 MU2 REV 1 05 qe o1eA 3Jog Tenueyy 6 1280 User s Manual Software BitmedLab BitmedLab User s Manual 3 10 1 GENERATING A REPORT To generate a report from the database Choose the patient right click on the test from which to generate the report and choose Create report FT Potent Tests H H CB Renier best 6 Document radinaianhy ipa Export test Delete The report generation wizard will start up The user can choose the range of the test to take into account for the calculation of all the statistical data of the test The user can also discard a epoch at the beginning and or end of the test or perform calculations between two marks notes Choose what you wish to do and click on Next 241121146 Select the test r
121. nel frequency and time instant where the cursor is positioned 534 740 MU2 REV 1 05 qe enue A 8281 User s Manual Software BitmedLab BitmedLab User s Manual O3h43m48s 05 35 425 07 27 m36s O9h19m30s 11h11m24s 6 2 2 MODIFYING THE COLOR SCALE By default the program automatically adjust the color scale taking into account the highest power found However the color scale can be easily modified Right click on the color scale In the menu that appears select palette options H 5 0 14 19 Hz 3 3 43 Color palette settings 12 26 00 24 9 11 67 7272 In Color palette options select the maximum and minimum values for the graph scale Click on Accept to apply the changes Colour palette value 5 00 Min value 0 00 6 2 3 CHANGING THE FREQUENCY SCALE Right click on any part of the graph and select Properties 534 740 MU2 REV 1 05 BitmedLab User s Manual Test 08D54D57 F6A5 4A68 BA20 BCF6995EF4B2 XGP eXim Apnea 12 ch 8006112901 Frequency Hz 000 0 OhO1m00s Power PWH 20 00 2 2 18 08yVvz Hz 18 18 Vz Hz 17 270V Hz 16 36yV2 Hz 15 46yV7 Hz 14 55 pVHz 13 64 V4Hz 12 73 pV4Hz Export as text 1182 0v2z 10 94pV2 Hz 249 10 00 p V2tHz 9 09 yVvz Hz 7 27 6 36uVaHz 5 45yV2 Hz 4 55 yVz Hz
122. ng While reviewing the test a series of epochs can be selected to be printed at the same time 534 740 MU2 e REV 1 05 qe enue A 8281 User s Manual Software BitmedLab BitmedLab User s Manual Choose the epoch on the screen by clicking on Select for printing epoch is selected and distinguished from unselected epochs by a purple mark in the time reference area a NA When you have finished choosing the epochs go to File Print and when the Printing options window appears choose Selected epochs in the Printing range section Preliminary printing view Go to File Preliminary presentation Choose the items you wish to include in the preliminary view You can also choose this window if you wish to preview the complete test only the epoch being viewed on the screen or the epochs selected for printing The epoch being viewed on the screen can be printed from the preliminary presentation 4 7 GENERATING REPORTS 4 7 1 GENERATING A REPORT To generate a report from the database Choose the patient and the test for that you wish to generate the report for Click on See report In the window choose the report template to used new template generated will be added automatically to this list If a report has already been associated with the test it will open automatically otherwise a new report will be generated depending on the template tha
123. nnel Sensor nang Comments Color 506060 amping rate 25 Saf eee thick 2 invest ee efor Lov pacs Filler Hia pass fikar value mex 000 Minimum value rmn 5000 Lini s Show values over te Click on Close when you are done 534 740 MU2 REV 1 05 BitmedLab User s Manual 3 9 10 ADJUSTING WAVEFORM SIZES When the cursor passes over the separating lines of the waveforms it changes to two arrows This indicates the possibility of dragging the separation line to change the height of the waveform Pull the line up or down while left clicking to change the height of the waveform to the minimum or maximum height This functionality can be enabled or disabled from the Allow changes to the waveform size option in the Viewing tab in the Viewing options window on Th 3 9 11 MODIFYING THE VIEWING ORDER OF THE WAVEFORMS Open the Viewing options window from the Analysis toolbar button or from Analysis menu gt Viewing options Enable the Montage tab In the Waveform window list select the waveform window where the changes to the waveform viewing order will be made top or bottom To change the order of a channel click on the channel and without releasing the left click drag it to the new position Release the left click When you have finished adjusting the order of the waveforms 534 740 MU2 REV 1 05 IIEMYO enu
124. nts and Settings Mis dacumentostradiography jpg lt Link document Delete link Open document 4 2 3 SEARCHING IN THE DATABASE Use the Search field of the database window to filter the patients shown in the list For example you can search for a specific patient by entering the last names in the search field 4 2 4 TESTS PENDING REVIEW OR REPORT The Tests pending review button displays a window with the list of all the tests that have been downloaded to the PC and have yet to be reviewed 534 740 MU2 REV 1 05 qe enue A 8281 User s Manual Software BitmedLab BitmedLab User s Manual Pending tests to be reviewed 4 total of 1 tests need to be reviewed STATUS PATIENT TEST START DATE TIME DURATION PATH Recorded Jones Adam 01 02 2011 13 52 13 O8h 00m 44192 168 0 144 BitmedLab tests B8E1C318 895E 46DB On the other hand the Tests pending reports button is similar to the one above but in this case it lists the tests that have been reviewed but for which a report has not yet been generated Pending tests to be reported 4 total of 3 tests need to be reported STATUS PATIENT START DATE TIME DURATION PATH Reviewed Sanders Tom 11 01 2011 12 00 42 08h 00m 11192 168 0 1441BitmedLab tests 773956CD D64B 478E Reviewed O Seal Sarah 18 01 2011 16 59 57 05h 06m 11192 168 0 1441BitmedLab tests A39F72C7 203F 4C44 Reviewed Jones Adam 01 02 2011 13 52
125. odifying predefined notes The default text provided by the program when entering notes can be completely customized to user preferences This is done by editing the notes txt text file in the application folder default X Program files Bitmed BitmedLab x x Remember to enter one note per line 4 6 8 ADJUSTING WAVEFORM RANGES Adjusting ranges with keys or the mouse Left double click on the waveforms that you wish to change the range of The background of the channel will change color uv 74 Ju EC h Jd aN 1 Use the keys to increase or decrease the range of selected waveforms 534 740 MU2 REV 1 05 qe enue A 8281 User s Manual Software BitmedLab BitmedLab User s Manual 212 uv o hax h m P The amplitude of any channel may also increased or decreased by clicking on it and then pressing the and keys while holding the left mouse button Accurately adjust the amplitude of a channel sleep disorders Right click on the waveform to be changed and select the Channel properties option The Channel options window will open Change the values in the viewing range and enter the maximum and minimum values that you wish to see on screen for that channel Wavoform settings lnputchannet 24 Monopolal EEG Comments Foz
126. olbar A window will appear showing the impedance of each electrode according to the following color code Black the electrodes in the air and impedance is higher than 80 Very poor contact Red impedance between 22 and 80 Poor contact Yellow impedance between 6 5 and 22 Regular contact Green impedance under 6 5 Good contact 534 740 MU2 REV 1 05 qe 1105 Tenuey sos User s Manual Software BitmedLab BitmedLab User s Manual Impedance meter Place the electrodes again as needed and click on Continue when finished A note will be inserted in the test indicating the instant when impedances were measured RISUS Impedance measurement MOUs 4 4 5 SIGNAL TEST Entering and exiting the signal test mode while the test is being performed At any time during the performance of the test the user can use the Signal test button on the Test toolbar to momentarily stop recording the data from eXea in the PC However the biomedical signals will continue to be displayed on the screen Use this option for example to relocate a sensor that has moved or been placed incorrectly and to check changes in the sensor signal without any of it being stored in the test SIGNAL TEST MODE NO DATA WILL BE SAVED To continue the test from the point at which the signal test had begun click again on the same button 534 740 MU2 REV 1 05 BitmedLab Us
127. omedical signals and they will be displayed on the screen in real time The data will also be stored in the internal memory of the device 4 4 2 PAUSING AND RESUMING A TEST The test can be paused and resumed momentarily at any time Click on the 2 button or go to Communication Pause continue test Test acquisition will stop If a test with video capture is paused the video window will also pause therefore if you move through the test the video will not synchronize with the time instant being 534 740 MU2 REV 1 05 BitmedLab User s Manual viewed This feature is accessed by stopping the communication with End test However the user should take into account that once a test with video has been completed it cannot be continued To continue the test from the point at which it was paused click again on the same button or on the same menu option 4 4 3 COMPLETING TEST ACQUISITION Click on the button or go to Communication End test The test recording will stop after a few moments and the device will stop recording data in the memory card If a test that includes video capture finalizes the recording cannot be continued afterwards Once the test is completed the test can be reviewed and the video will synchronize fully with the time being viewed 4 4 4 MEASURING IMPEDANCES During real time test performance electrode impedance can be checked at any time Click on Measure impedances 2 in the test to
128. on that can be then loaded directly or established by default for all the new tests to be performed You can find more information on managing default configurations further 534 740 MU2 REV 1 05 BitmedLab User s Manual along in this manual To apply an existing configuration or settings other than the default settings to the test choose the them from the list and click on Read configuration Configurations Montage Test Traces Power frequency time Power frequency map Video eeg exim Apnea exim Pro EEG 1 exim Pro EEG 2 exim Pro EEG 3 exim Pro PSG Load configuration Save current configuration Delete configuration Set as default Import configuration Export configuration Enable the Test tab and click on Test data A dialog will open for the user to enter the test data These data appear in the report generated by the program and in the test epoch printouts Click on Accept when you are done 534 740 MU2 e REV 1 05 qe enue A 8281 User s Manual Software BitmedLab BitmedLab User s Manual Test data Patient data Case history 1621 345 First name Saint Surname Peter Sex Date of birth Year 19 78 Mont 2 Day ho Address City State Province ZIP code Thelephone Cell phone Fax E mail Weight kal Heigh
129. onfiguration name letters from A to Z and numbers from O to 9 3 3 2 SETTING THE DEVICE DEFAULT CONFIGURATION USING BLUETOOTH ONLY SLEEP amp GO Click on Device configurations in the home screen Each device configuration is associated with a Sleep amp Go system by means of a specific serial number The first step in the wizard is to choose the device that you want to establish the configurations for Click on Next Configurations Device Select the polygraph to be configured Device leep amp Go B model S N 3 In the next screen choose Set the manual start configuration Bluetooth and click on Next 534 740 MU2 REV 1 05 BitmedLab User s Manual Function selection What do you want to do Manage the configurations in the memory card Choose one of the configurations in the list You can modify a configuration in the list or create a new one by clicking on the Edit PC configurations button The graph shows the channels that will be acquired green or not red depending on the setting chosen You can also edit a configuration in situ activating or deactivating channels by clicking the appropriate button If you also want to Save the changes as a new configuration click the Save button and the program will ask for a name for the configuration Click on Next Configurations Configuration selection Configurations available in the PC 3 Advanced editinn E
130. orm list Click on Delete and the channel will disappear from the list of visible channels Click on Accept to close the window and apply the changes 534 740 MU2 REV 1 05 qe o1eA 3Jog Tenuey 6 1281 User s Manual Software BitmedLab BitmedLab User s Manual Deleting all the waveforms Go to the Analysis menu Viewing options Enable the Montage tab and select the view you wish to set up from the Waveform window list Click on Delete all to delete all the waveforms at once Click on Accept to close the window and apply the changes 3 9 16 CHANGING THE SOFTWARE FILTERS Right click on the waveform to be changed and select the Channel properties option Waveform settings Tid an any property bo change die value Channel 5606060 SW eieefem thick ness 2 invest ee efor Low pacs Filler 45 Hz High pes fitar 10 Hz value mex 50001 Minimum value mn 5000 4 Units Show values over the High pass Filler High peas liar applied ta the signa Choose the low pass and high pass filters you wish to use and click on Accept to apply the changes Remember that the filters that are available will depend on each channel 3 9 17 CHANGING THE SIGNAL WAVEFORM COLOR The waveforms for each type of sensor are given a different color by default but all these colors can be modified In the waveform window right click on the waveform to be chan
131. orward half epoch Use the Advance a half epoch 2 button on the Viewing toolbar to advance a half epoch This option is useful for a clear view of events that occur at the limit between two consecutive epochs Using the Go to instant option Open the Analysis menu Go to instant The user can specify the hour and minute of the test he wishes to go to in the box that appears Go to instant to instant 2 hous 10 minutes Click on Accept for the test to automatically go to the indicated instant Using the browsing marks If there is a place in the test of special interest that you wish to refer to in the future a browsing mark can be inserted at that place from the Analysis menu Insert browsing mark or by pressing on the Ctrl M key combination The mark is shown as an upside down red triangle on the time scale 534 740 MU2 REV 1 05 qe o1eA 3Jog Tenuey 6 1281 User s Manual Software BitmedLab BitmedLab User s Manual OOO ros OhOOm355 To return to the same point again simply go again to Analysis gt Browse to browsing mark or press on the Ctrl N key combination 4 6 6 ADJUSTING TIME ON THE SCREEN The time scale at the top of the waveform window shows the test time and the size of the epoch The size of the epoch also appears on the status bar Adjust the time on the screen with keys and and icons TA Use the and keys to multiply or divide the si
132. pne 7 Minimum duration apneas Minimum duration hipopneas Themocouple airflow channel Pressure transducer airflow channel Pressure transducer airflow channel Use thoracoabdominal sum Delete apneas hipopneas coincidin Central apnea classification criteria Mixed apnea classification Desaturations 02 desaturation threshold Make the desired changes in the criteria for automatic analysis of events An explanation of each of these parameters is shown when you click on the parameter To return to the program default values click on Reset default parameters Click on Accept to apply the changes 534 740 MU2 REV 1 05 BitmedLab User s Manual 3 9 25 MANUAL MARKING OF SLEEP EVENTS Marking events with the mouse Place the cursor over any of the waveforms and click on the place where you wish to start the event Drag the mouse to mark the duration of the event The selected duration will appear in the status bar If you have clicked on an air flow or breathing effort waveform the desaturation associated with the selection and the signal variation will also be shown These data are useful for marking apneas and hypopneas Desat 6 Var 82 3 Sel 16 265 When the selection has been completed a contextual menu will appear with all the event types Choose the one you wish to mark Obstr apnea Central apnea Mixed apnea Desaturation Obstr
133. pnea Central apnea Mixed apnea Arousal Desaturation Movement Obstr hypop Central hypop Mixed hypop Snore RERA Flow lir Mov Tachycardia Bradycardia PLM Bruxism Periodic brea Cheyne Stokes brea Undetermined resp event Zoom to selection Frequency spectrum Copy selection Delete Export to new file Export ASCII Unselect Deleting events with the mouse Press the Control key The cursor changes to an arrow with the sign Do not release the Contro key and click on the event to deleted Deleting events from the event mark Place the cursor over the event you wish to delete and right click Choose the Delete event option the contextual menu Deleting all the test events Choose the Delete all events option in the Analysis menu Confirm that you wish to delete all the test events 534 740 MU2 REV 1 05 qe enue A 8281 User s Manual Software BitmedLab BitmedLab User s Manual Changing the way the event marks appear on the screen The event marks on the channel waveforms can be viewed in different ways Detailed a text appears on the mark that includes the event type the initial instant and its duration Brief a text appears on the event mark only with the short name of the event type Zh No description no text appears The event type is distinguishable only by the color of the mark
134. port The report templates are based on the use of a series of labels that are later interpreted by the software to generate the reports For example if a line in the template is Name name_pat the program will replace the label with the real name of the patient so the report shows 534 740 MU2 REV 1 05 BitmedLab User s Manual Name Nuria Pino Torres If on the contrary the template has Total recording time min the generated report will replace the TRT label with the total recording time Total recording time 182 min Any of the report templates supplied by default with the program can be opened in your usual text processor to verify its appearance Refer to the CD supplied with the software to familiarize yourself with the complete list of available labels to customize your reports Briefly the steps to create a report template are as follows Open a word processor such as Windows Write or MS Word Create a new document or edit any of the report templates in the Templates folder Customize the report You can use tables text formatting bold various fonts colors insert images etc The text entered will appear the same the report while the labels with the Zname _ label format will be automatically replaced with a value calculated by the program When you have finishes save the file with the RTF extension in the Templates folder From now on the new temp
135. raphy Screening Import Delete Export Enter a name for the montage 534 740 MU2 REV 1 05 qe enue A 8281 User s Manual Software BitmedLab BitmedLab User s Manual Importing and exporting a montage BitmedLab allows the user to export any of the montages to a file so that it can be easily imported into another computer Go to the Analysis menu Viewing options Enable the Montage tab and click on the Manage montages button Choose the montage you wish to export from the list of available montages and click on Export A dialog will appear to choose the name of the file that will store the montage and the folder to save it in The montage will be saved in a file with extension xcp A montage can be imported in a similar manner Click on Import in the Manage montages window A dialog will appear to choose the xcp file corresponding to the montage that is to be imported The montage will be added to the list of available montages Deleting a montage Go to the Analysis menu Viewing options Enable the Montage tab and click on the Manage montages button Choose the montage you wish to delete from the list of available montages and click on Delete 3 9 22 TYPES OF EVENTS BitmedLab defines a series of event types that the user can use in the tests For user convenience BitmedLab limit the available event types according to the group of event types that are
136. rd Click on Next Programming method Select the programming method 534 740 MU2 e REV 1 05 qe enue A 8281 User s Manual Software BitmedLab BitmedLab User s Manual Finally a summary of the automatic test to be performed is shown Click on Finish New programmed test wizard Step 6 6 Summary Screen amp G The test will be scheduled with the following data lrest 1002 Patient Gattlin Sam Device 3 Reference doctor Dr Anderson Technician Susan Collins Date 21 2 2011 Duration 8 hours 0 minutes Configuration ALLSENSO Airflow pressure transd 50Hz Airflow thermocouple 10Hz Thoracic effort band 10Hz Abdominal effort band 10Hz Movement Auxiliary 50Hz Snoring 250Hz Body position 1Hz Activity 25Hz CPAP pressure 1Hz EKG EXG 1 100Hz EKG EXG 2 100Hz Movement EXG 3 100Hz If the test was programmed via the memory card wait until the program delivers a message indicating that programming has been completed successfully Remove the card from the card reader and place it n the device again Switch on the device and wait until the main screen appears the one with the manual start option The device will detect a new test and is now ready for use Now you can switch off the device 3 5 DOWNLOADING THE COMPLETED TEST Once a test has been obtained in holter mode whether started automatically or manually it is
137. resentation of brain mapping It consists of a zenital view of the patient s head showing the standard 10 20 electrodes and the power contained in each point for the chosen frequency by means of a color scale The right hand area shows a graph of the power contained in each frequency for each channel The data are calculated in 30 second epochs Use the time bar to update the power frequency map with the activity of a specific time instant Choose Power frequency map in the See menu or click on the button in the toolbar The program will request which electrodes to show in the map to calculate the FFT Channel selection for the power frequency map view Available channels Selected channels Select the channels to apply the FFT in the power frequency map After the FFT has been calculated the power frequency map will appear 534 740 MU2 REV 1 05 qe o1eA3Jog enue A 6 1280 User s Manual Software BitmedLab BitmedLab User s Manual 54D57 F6A5 4A68 BA20 BCF6995EF4B2 XGP m Archivo Edici n Ver Equipo Analisis Herramientas Ventana Ayuda A FI YE Ho TRE WOCHEN OE Biniak lg 1 8 Qi x 2 total 6h Customized montage 7 35 50 Hz Y 3 Power 0800 0 OhO1mO0s 7 6 Hz Power p V2 Hz 0 56 0 54pV2lHz
138. s this opens a wizard that allows the user to manage the device configurations used to perform the polygraph 534 740 MU2 REV 1 05 BitmedLab User s Manual or screening studies See Section 3 3 New scheduled test this opens a wizard that allows the user to program a test for a specific date and time See Section 3 4 Download tests this opens a wizard that allows the user to download tests from the Screen amp Go Sleep amp Go system to the PC It also allows subsequent review of tests See Section 3 5 Database open the patients and tests database Patients and their tests can be managed from the database new patients discontinued patients test reviews consultation of work pending etc See Section 3 6 Settings this accesses the general options of the program user data type of events custom keys general options etc The home screen can be accessed at any time by clicking on the icon of the toolbar SleepLab Main screen baks File View Polygraph Tools Window Help o BITMED Press F1 for help 534 740 MU2 REV 1 05 qe enue A 8281 User s Manual Software BitmedLab BitmedLab User s Manual 3 3 TEST SETTINGS Each polygraphy or screening test of the OSAS can be configured previously so the device recognizes which channels sensors are going to be acquired and the sampling frequencies that are going to be used
139. scale of the waveform window 1001155 Audible 205 Entering a note There are two different ways to enter notes Select Enter note in the Analysis menu Press the Insert key on the keypad A box will appear for the user to enter the text of the note The user can also choose one of the predefined notes that appear If the test is in real time the note will appear overwritten at the instant it is being acquired However if a test that has already been acquired is being viewed the note will appear overwritten at the instant corresponding to the center of the screen being viewed at that time Enter note Tow Modifying a note Right click on the note to be modified Select Modify note in the contextual menu that appears This note Delete note The Enter note window will appear Modify the text and click on Accept to apply the changes Deleting a note Right click on the note to be deleted 534 740 MU2 REV 1 05 BitmedLab User s Manual Select Delete note in the contextual menu that appears Delete note Modify note Showing hiding notes Go to the Analysis menu gt Viewing options or from the corresponding button of the Viewing toolbar Enable the Viewing tab Enable the Show notes option to show the notes on the screen and disable the option to hide them Click on Accept to apply the changes Modifying predefined notes The default text provided by the program whe
140. sis menu Viewing options Enable the Waveforms tab Mark the box that corresponds to the See numerical values cursor option 534 740 MU2 REV 1 05 qe enue A 8281 User s Manual Software BitmedLab BitmedLab User s Manual Click on Accept to apply the changes Once the bottom waveform window is visible it also displays a cursor that is synchronized with the cursor in the top window always so that it always marks the time instant of the top waveform window c g 4 6 22 DEFAULT CONFIGURATIONS A default configuration stores all the settings of a test under a descriptive name This includes Channel settings sensors filters gains colors descriptions order on the screen etc Screen settings epoch duration event mark viewing real time display mode event bar viewing channel sizes etc In general terms all the parameters that can be set from the Viewing options window are stored in the default configuration The default configurations are saved with a name and can then be loaded and applied to the test at any time whether on starting a real time test setting up the device for use in holter mode 534 740 MU2 REV 1 05 BitmedLab User s Manual downloading a test to the device memory or during review In addition if the same type of test is performed on a regular basis a default configuration can be establishe
141. software 7 Bitmed Virtual Port Setting a system restore point and backing up old files in case your system needs to be restored in the future Once the driver installation is completed click on Close 534 740 MU2 REV 1 05 qe enue A 8281 User s Manual Software BitmedLab BitmedLab User s Manual Found New Hardware Wizard Completing the Found New Hardware Wizard The wizard has finished installing the software for 7 Bitmed Virtual Port Click Finish to close the wizard Then access the Windows Control Panel from the Start menu gt Control panel Access the Performance and maintenance gt System option Click on the Device manager button in the Hardware tab Open the Universal serial bus USB drivers option and double click on Bitmed device The Bitmed device Properties window will open Choose the Advanced tab and disable the Load VCP option If the Load VCP option does not appear restart the PC and repeat this step Click on Accept and close all the windows that have been left open Disconnect the Bitmed eXea from the USB port and connect it again 2 3 2 WINDOWS VISTA WINDOWS 7 AND WINDOWS 8 Connect the eXea system to a free USB port in the PC Windows will attempt to install the device automatically 7 Installing device driver software gt X Click here for status However Windows will not install the device driver automatically Ope
142. st It can also be used to change the time per epoch and the and the montage used Waveform window this window displays the signals recorded by the Screen amp Go Sleep amp Go The screen can be customized in a variety of ways Trend window this window provides summarized information about sleep events and light status It provides a summary of the test at a glance Status bar this provides contextual information while the program is being used 3 9 2 OPENING A TEST Choose the patient to whom the test is associated or search for the patient using the Search text box Display the Test folder in the patient tree Locate the test to be reviewed and right click to pull down the contextual menu and choose the Review test option A Palier e Tes IDEEIGESEU ET Documents D redegrspos pg If the automatic analysis of test events has not been performed a wizard will start automatically to guide you through the analysis process If you do not wish to perform the automatic analysis cancel the wizard 3 9 3 FULL SCREEN MODE Use the full screen mode to maximize the available screen space to review the test The Windows task bar the title bar of the application and the toolbars will all disappear in this mode display them by going to the View menu gt Toolbars and docking windows 534 740 MU2 REV 1 05 BitmedLab User s Manual Go to View Full screen to enter the full screen mode To exi
143. t appear restart the PC and repeat this step Click on Accept and close all the windows that have been left open Disconnect the Bitmed eXea from the USB port and connect it again 2 4 INSTALLING THE BLUETOOTH MODULE SLEEP amp GO SYSTEMS If you have purchased a Bluetooth module with your Bitmed Sleep amp Go system follow the instructions in the manual of the module to install the module driver 534 740 MU2 REV 1 05 BitmedLab User s Manual 3 USING THE PROGAM WITH THE SCREEN amp GO AND SLEEP amp GO SYSTEMS 3 1 FIRST STEPS 3 1 1 STARTING UP THE SLEEPLAB MODULE There are two ways to start the SleepLab module Click on the SleepLab icon in the Windows Desktop In the Windows Start menu click the programs go to BitmedLab folder and click on the SleepLab icon 3 1 2 REGISTERING THE SCREEN amp GO SLEEP amp GO IN THE SOFTWARE Before starting to use your Screen amp Go Sleep amp Go system you must register it in the SleepLab software This procedure is required only once and ensures that your program recognizes the characteristics of your computer and those of the optional modules you have purchased Go to the Polygraph menu Device manager m Device manager Available devices Device Number of Bluetooth Serial number Automatic detection Delete Properties Make default device 0 available device s Ime Close Click on Automatic detection
144. t cmy 0 Insurance company Policy t Medical history Test data Test tt Start time date 2011 02 21 16 29 Reference doctor Performed by File name 8D8C61BF 25F0 4794 961 6 1 063B0427999 XGP Comments The transfer of memory data from the device to the computer will start The progress bar that appears on the screen indicates the percentage of the procedure completed When downloading is complete the program will indicate that the operation has finished If only one test has been performed the test will open directly for review If there is more than one test the program will display a window with the list of all the tests and their duration and will ask if the user wishes to separate the tests into different documents or keep them in a single document while annexing one recording after another 534 740 MU2 e REV 1 05 BitmedLab User s Manual The following tests were found in the device s memory 1 duration 00 hours 11 minutes 25 seconds 2 duration 00 hours 01 minutes 24 seconds If you want to divide the tests in different documents then click on the Divide button If you want to merge all of them in just one document then press Merge 4 6 REVIEWING THE TESTS 4 6 1 REVIEWING A TEST Have the database window open and choose the corresponding patient in the list Choose the test you wish to open and click R
145. t for all the new tests to be performed You can find more information on managing default configurations further along in this manual To apply an existing setting or a different setting than the default setting to the test choose it from the list and click on Read setting Enable the Test tab and click on Test data A dialog will open for the user to enter the test data Click on Accept when you are done The user can return at any time to edit the data contained in this window by accessing Viewing Options and Test 534 740 MU2 REV 1 05 BitmedLab User s Manual Test data Patient data Case history 1621345 First name Saint Surname Peter Sex ale Date of birth Year 1978 Mont 2 Address City State Province ZIP code Thelephone Cell phone Fax E mail Weight 0 Height cm 0 Insurance company Policy Medical history Test data Test Start time date 20 1 02 21 16 29 Reference doctor Performed by 8D8C61BF 25F0 4794 961 6 1 063B0427999 XGP Comments If you wish to check electrode impedances enable the Measure impedances before starting a new test box in the Test tab You can also enable the Measure impedances before continuing test acquisition option if you wish to check the impedances each time you pause and resu
146. t is selected Report selection Select the report that you want to generate Polygraphy report v 534 740 MU2 REV 1 05 BitmedLab User s Manual To generate a report when the test is open on the screen Choose Report in the See menu You can also use the button In the window choose the report template to be used Any new template generated will be added automatically to this list If a report has already been associated with the test it will open automatically otherwise a new report will be generated depending on the template that is selected For the calculation of the hypnogram and sleep statistics in a polysomnograph report to be made correctly the user must previously analyze the sleep stages in the test and mark the status of the lights off on Likewise for all event information to appear correctly the user must analyze it either manually or automatically If the stages are not defined the analysis module differentiates the wake sleep states according to the status of the lights If the test is edited after generating the report the report will have to be generated again for the changes to appear 4 7 2 PRINTING A REPORT With the report open and activated on the screen go to File gt Print Choose the printer printer properties printing interval and number of copies Click on Accept to start printing 4 7 3 SAVING A REPORT Go to File Save In Save as enter the name of the report f
147. t line systems Bitmed product line systems are delivered with all their accessories and with BitmedLab analysis software This manual describes the BitmedLab software Please read this manual carefully before using the BitmedLab software especially those sections marked with an exclamation mark BitmedLab software consists of two different modules that vary depending on the systems they support and the functionalities they offer SleepLab module to be used with the screening systems and Screen amp Go and Sleep amp Go polygraphs SleepLab Pro specialized module for the study of sleep disorders with the eXea system The two modules are distributed as the BitmedLab suite The manual covers aspects of the program that are common to all the modules as well as individual features of each module If you already have a Screen amp Go Sleep amp Go read chapters 1 2 3 and optionally chapters 5 and 6 On the other hand if you already have 534 740 MU2 REV 1 05 21e 3jogs enue A 5 28 User s Manual Software BitmedLab BitmedLab User s Manual an eXea system read chapters 1 2 4 and optionally chapters 5 6 and 7 1 2 INTENDED USE Acquisition storage display and analysis of biomedical sleep signals for diagnosis and control of sleep disorders Sleep Related Breathing Disorders Restless Leg Syndrome and Periodic Limb Movement Disorder Next conditions must be taken
148. t the full screen mode click on the Close full screen floating button or go to the View menu gt Full screen 3 9 4 DOUBLE WAVEFORM WINDOW The waveform window can be divided into two parts during review The two waveform windows can be set up with different time scales In addition each waveform can be displayed or hidden in either of the windows Therefore for example in a sleep study the top window can be configured to view the fast channels and the bottom window to display the slow channels each with a different time range The time scale used in the top window is shown in violet over the time scale used in the bottom window 3 9 5 PLAYING THE TEST Any of the tests that have already been performed can be played automatically at different speeds Place the cursor at the beginning of the part of the test that you wish to play This can be the very beginning or any other moment of the test Click on the Start playing test button on the play toolbar m The test will start playing exactly as it was acquired If you wish to double the playing speed click on the x2 button Increase the test playing speed If you wish to decrease the playing speed by half click on the 2 button Decrease the test playing speed E You can stop playing the test at any time by clicking the Pause playing test button You can start playing the test from the same point where it was stopped by clicking again on the Start playing t
149. tab of Viewing options Nonetheless the program will request confirmation before performing the procedure since the procedure is quite time consuming for long tests 5 5 COMPRESSING THE FILE AT ANY TIME Open the test that you wish to compress the video of Open the Viewing options window from Analysis Viewing options Enable the Video tab Start the video compressor by clicking on Compress video now The AV compression dialog will open where you can choose the file to compress the default file is the one associated with the active test and the name of the compressed file Click on Accept to start compression 534 740 MU2 REV 1 05 21e 3Jogs enue A 5 281 User s Manual Software BitmedLab BitmedLab User s Manual Compresion AV Input File CAPSG video sample Open Dutput File x 5 6 COMPRESSING A VIDEO FILE USING THE COMPRESORAV TOOL The BitmedLab software product line includes the installation of a tool called Compresor AV that can be used to compress video files without needing to start any of the software modules SleepLab SleepLab Pro In the Windows Start menu go to A programs gt BitmedLab and open Compresor AV lt gt COMPRESION AV Select the video file you want to compress under Input File Then select the name for the final compressed file under Output File and press Compress to start the process Input F
150. ted manually from all the patients in the database or a new patient created 534 740 MU2 REV 1 05 qe o1eA 3Jog enue A 7950 User s Manual Software BitmedLab BitmedLab User s Manual Patient Select the patient or click on the patient button PATIENT SURNAME 651287 Gattlin New patient The program will then download the test Wait until the process has finished When the message appears indicating that the transfer has been completed click on Next Progress Finished download Click on Next Once the test has been downloaded option appears to open it immediately for review In any event the test can be opened afterwards at any time from the database window Click on Finish 534 740 MU2 REV 1 05 BitmedLab User s Manual Analysis Screen amp G 3 6 MANAGING PATIENTS AND TESTS THE DATABASE The BitmedLab database provides easy management of all your patients and tests Access it by clicking on the Database button The database window is divided into two highly differentiated areas On the left is the list of patients showing the name last name and number of the patient The list can be ordered by any of these fields by clicking on the field header On the right of the patient list are the buttons used to add modify or delete a patient The area on the right is used to display a
151. tems or for flaws or accidents in other computer equipment 1 5 PRODUCT DISPOSAL The device support media is a CD The CD and the packaging can be disposed in the household trash but it is recommended to recycle the packaging No special consideration has to be taken when processing the CD media and packaging Note Korrvu packaging can be recycled with the film left in place 534 740 MU2 REV 1 05 BitmedLab User s Manual 2 INSTALLING THE SOFTWARE 2 1 REQUIREMENTS Required Recommended MS Windows Vista Operating system 7 or 8 Intel Pentium 4 Double core AMD Athlon processor Memory 1024Mb 2048Mb Several gigabytes Free space in to acquire hard disk synchronized digital video Processor Screen amp Go Sleep amp Go 2 if a Bluetooth module and card reader are USB Ports 1 1 used 1 Screen resolution 1024 x 768 1280 x 1024 or higher Free PCI Xpress slot Capture of PCs synchronized digital video Free Xpress Card slot Laptops 2 2 INSTALLING BITMEDLAB We recommend closing all the applications running in the system before starting the installation This reduces the possibility of conflicts between software affecting the installation Take the following steps to install the BitmedLab software product 534 740 MU2 REV 1 05 qe enue A 8281 User s Manual Software BitmedLab BitmedLab User s Manual line Make s
152. th its weight when the values of each electrode are averaged to generate the reference Electrode weights goes from 0 to 1 The default weight of all the electrodes is 1 534 740 MU2 REV 1 05 BitmedLab User s Manual Average reference Show weights If you wish to distribute the weight of the electrodes evenly click on Equalize To change electrode weights manually click on the electrode while the weights are being displayed and enter the new weight of the electrode in the Edit electrode weight window Electrode weight Weight 0 25 When you have finished editing the averaged reference click on Accept to close the window 4 6 19 CHANGING THE SIGNAL WAVEFORM COLOR Each type of sensor is given a different color by default but the colors of each of the waveforms can be easily modified Right click on the waveform to be changed and select the Channel properties option in the contextual menu The Channel properties window will open There is a Co or box with the current color setting of the signal waveform Click on the color box to open the color selection dialog and choose the new color for the signal waveform Click on Accept when you are done 534 740 MU2 e REV 1 05 1105 Tenueyy 6 1281 User s Manual Software BitmedLab BitmedLab User s Manual Waveform settings Inpubchanret 3 Sarra EEG Colones Lammerts ENI p gm
153. the Time toolbar If you wish to quickly change the default configuration applied to the test display the list of settings in the Time toolbar Choose the new configuration and these will be applied instantly dM ay Oh p Them Montaje personalizada Establishing default settings for new tests Go to the Analysis menu Viewing options Enable Default configurations In the list of available configurations choose the one you wish to establish as default Click on Establish as default The program will ask whether you wish to apply the configuration 534 740 MU2 REV 1 05 BitmedLab User s Manual to the active test Click on Accept to apply the changes Exporting and importing default configurations The program allows the user to export a configuration to a file so that they can be easily imported into another computer Go to the Analysis menu Viewing options Enable Default configurations In the list of available configurations choose the one you wish to export Click on Export configuration A dialog will appear to choose the name of the file that will store the default configuration and the folder to save it in The configuration will be saved in a file with extension xcp The procedure for importing a default configuration is similar Click on Import configurations in Default configuration A dialog will appear to choose the xcp file corresponding to the default configur
154. tion event mark viewing event bar viewing channel sizes etc In general terms all the parameters that can be set from the Viewing options window are stored in the montage The montages are stored with a name and can then be loaded and applied to the test at any time during review The montages are managed from the Montage tab of the Viewing options window The currently selected montage is shown in the Montage list as well as in the list of montages in the Time bar Choosing a montage The montage can be changed quickly from the waveform window by selecting it from the list in the Time bar Customs montase 2 CPAP titration F The montage can also be changed from the Montage tab of Viewing 534 740 MU2 REV 1 05 BitmedLab User s Manual options window Current montage Montage 17 CPAP titration Trace a Screening Customized montage Airflow thermocouple Once the test has been configured as desired go to Viewing options and enable the Montage tab Saving a montage Click on the Manage montages button 4 Montage Current montage Available channels Montage lt 17 Trace window Click on Save in the Manage montages window The program will request a name for the montage Enter the name and click on Accept If there is already a configuration with the same name the program will request confirmation to overwrite it CPAP titration Polyg
155. ure the manufacturers guarantee 1 000 000h At 70 C the life is reduced to 2 000 h See specifications of CD ROM for more information The screen resolution specifications are recommended for a comfortable use of the system while reviewing the studies Take into consideration the applicable regulations in terms of occupational safety 534 740 MU2 REV 1 05 BitmedLab User s Manual ANNEX 5 SYMBOLS MANUFACTURER MANUFACTURER S NAME AND ADDRESS MANUFACTURING DATE TEMPERATURE LIMITATION WARNING 534 740 MU2 REV 1 05 qe enue A 8281 User s Manual Software BitmedLab BitmedLab User s Manual ANNEX 6 MAINTENANCE The BitmedLab software does not require any specific maintenance except that for any computer program handling information Make a copy in a CDROM in case the original gets damaged e Make periodical backup copies of the Data Base test files and report files in order to be able to restore them if any loss of information occurs in the computer The software is improving continuously Therefore contact regu larly with the Technical Assistance Service at SIBEL S A to get the latest updates If any problem doubt or suggestion arises while using the product or if you require additional training please follow the next steps 1 Use the help windows available in the program 2 Use this User s Manual properly 3 Check that you ha
156. ure the system has the necessary administration rights to install the drivers and applications Click on Run in the Start menu of the Windows task bar The Run dialog box will appear Write X setup exe in the text box and click on Accept X is the DVD CD ROM unit or access path to the folder containing the installation file Click on Browse to locate the correct files in the hard disk or in the DVD CD ROM The installation program will immediately show the first panel of the installation wizard Click on Next gt to continue BiimedLab 1 01 InstallShield Wizard Welcome to lhe InstallShield Sa re nl for Em The val irstal BitmedLab 1 071 on continua click Mast The installation program can perform a complete program installation or customize the elements of the program to be installed Choose the option you prefer and click on Next 534 740 MU2 REV 1 05 1 01 InstallShield Wizard Setup Type Select 10 Fee T a setup Comalsta All eil be nstelied Ihe modules SIespl ab 5leenl 4b Pro and EEGLeb Select which ealbaan modules Sheepl ao Pre ar E EGLabl and program feat You wart installed The next panel of the wizard lets you change the folder where the program files will be copied If you want to change the default folder click on Change When you are
157. ve the latest version installed 4 Contact with the After Sales Service of SIBEL S A at You can also check the Known abnormalities report 534 741 MU2 available to the user from SIBEL S A SIBEL S A Rossell 500 08026 BARCELONA SPAIN SERVICIO POSTVENTA Tel 34 93 433 54 50 FAX 34 93 436 16 11 e mail sat sibelmed es 534 740 MU2 REV 1 05
158. veforms depending on the property settings of the event type If the trends window is open a mark will also appear on the corresponding event type bar and the length will depend on the duration of the event Finally the number of event occurrences will increase by one Obstructive apnea S 0 8 0 0 12 695 Lights A obs 1 A cen A mix Marking events with the keypad Press the key associated with the event The program will insert a mark starting at the beginning of the epoch on the screen with a specific duration for this type of event 534 740 MU2 REV 1 05 qe o1eA 3Jog Tenuey 7950 User s Manual Software BitmedLab BitmedLab User s Manual Refer to the Customized keys tab of the Settings Tools gt Options window for the key associated to each type of event You can also check the hoykeys in Annex 3 of this manual Marking event with the mouse and the keypad Press on the key associated with the event that you wish to mark The cursor changes to an arrow with the sign Do not release the key and select the part of the test where you want to mark the event Release the key to mark the event Use the event marking toolbar Choose the type of event that you wish to mark C3 3 0 2 3 3 3 The cursor changes to arrow with the sign Unless you click again on the event type icon all the events that are marked will be of the same type Do not release the
159. ware from other sources may harm your computer or steal information See details Once the device driver installation is completed click on Close Update Driver Software Bitmed Device Windows has successfully updated your driver software Windows has finished installing the driver software for this device Bitmed Device Close Windows will detect another new device but will not automatically install the driver of the device Open the device manager via the Start menu Control panel Hardware and sound Device manager In Device manager locate the Bitmed virtual port entry and double click on it Choose the Driver tab and click on the Update driver button Click on Search for driver software on your computer Use the Browse option to find the USB Drivers folder in the BitmedLab software CD Click on Next 534 740 MU2 REV 1 05 21e 3jogs enue A 5 281 User s Manual Software BitmedLab BitmedLab User s Manual Windows will show a message indicating that the publisher of the driver software could not be verified Click on Install this driver software anyway Once the device driver installation is completed click on Close In Device manager open the Universal serial bus USB drivers option and double click on Bitmed device The Bitmed device Properties window will open Choose the Advanced tab and disable the Load VCP option If the Load VCP option does no
160. wer the actions performed upon it To activate this option you must first enable the audit of the aforementioned file At this level you must specify the users according to the users which access the BITMEDLAB HOME gt data directory and types of access to be audited The log file audit can be activated from the Security tab of the file Properties Using the Advanced button you can access the Audit tab From here simply add the users and the type of 534 740 MU2 REV 1 05 enue A 8281 User s Manual Software BitmedLab BitmedLab User s Manual access to be audited It must be taken into account that if all actions on the log file are audited the security events viewer will have many entries and will complicate the monitoring of unauthorized accesses The next stop is to activate the audit of access to objects in the local security configuration To do so access the Administrative Tools icon from the Control Panel Once there you must select the Local Security Directive and the Local Directives branch from the directives You must then access Audit Access to Objects Both correct and erroneous accesses can be enabled Finally the folder where the test and report files are stored may also be audited usually My documents BitmedLab tests Access register description Access to the different databases is stored on the one log file BITMEDLAB log in the folder where the application
161. will be added to the patient Import test Select the test bo be ta the dalabaze ll 534 740 MU2 e REV 1 05 qe enue A 8281 User s Manual Software BitmedLab BitmedLab User s Manual Exporting tests To export a test select it in the database and click the right mouse button Select Export test in the menu Patient Teste Pod Documarte 09 radogaphp p Raten teat Craaba report Export best Delate In the Save As dialog box select the name and path to the file where the file will be saved 3 8 PERFORMING TESTS IN REAL TIME ONLY SLEEP amp GO You can perform store and monitor tests in real time directly in the PC with all the Bitmed Sleep amp Go systems including the Bluetooth module 3 8 1 STARTING THE REAL TIME TEST Place all the sensors and electrodes required for the test on the patient as described in the User s Manual of the device In the database window choose the patient to whom the test will be associated and click on the Start a new real time test with the Sleep amp Go button Patient Tests 12 01 2011 12 24 06 00h 00m Reviewed 8 Documents If more than on Sleep amp Go is available choose the one you wish to perform the test with 534 740 MU2 e REV 1 05 BitmedLab User s Manual The Configurations window will appear Choose the device configuration that you wish to use Configurations
162. xtual menu Deleting all the test events Choose the Delete all events option in the Analysis menu Confirm that you wish to delete all the test events Changing the way the event marks appear on the screen The event marks on the channel waveforms can be viewed in different ways Detailed a legend appears on the mark that includes the event type the initial instant and its duration Brief a legend appears on the event mark only with the short name of the event type and the duration Obs 50 No description no text appears The event type is distinguishable only by the color of the mark or the waveform on which it appears 534 740 MU2 REV 1 05 BitmedLab User s Manual Events inserted manually show the mark M while events detected by automatic analysis show the mark A Toggle between the three views by using the E key or from Viewing options Open Viewing options from Analysis Viewing options and enable Waveforms Choose the option you wish to use in Event mark descriptions Click on Accept to close the window and apply the changes 3 9 27 CALCULATING THE PTT The Sleep amp Go polygraph allows acquisition of the ECG signal using the optional ExG channel module and pulse wave optional in model A and serial in model B These two channels generate a third calculated channel the PTT Pulse Transit Time This channel shows the time it takes the pulse wave to travel
163. y Click on the Next button of all the screens until the installation of PrimoPDF has been completed If you chose the install XGPVision a window will appear indicating that the software is installing hardware that has not passed the Windows logo test Click on Continue 534 740 MU2 REV 1 05 BitmedLab User s Manual Hardware Installation d The software you are installing for this hardware Sound video and game controllers has not passed Windows Logo testing to verify its compatibility with Windows Tell me why this testing is important Continuing your installation of this software may impair or destabilize the correct operation of your system either immediately or in the future Microsoft strongly recommends that you stop this installation now and contact the hardware vendor for software that has passed Windows Logo testing STOP Installation If a message appears requesting confirmation to overwrite files click on No to all When the installation is complete click on Finish The BitmedLab software line of products is ready for use 1 01 InstallShield Wizard Shield wizard Complete The Install held has instabed a5 141 Check Finch fo eyil ngad installi 2 3 INSTALLING THE USB DRIVER EXEA SYSTEMS The first time the Bitmed eXea system is connected to the PC Windows detects the new device and requests the necessary files to install
164. ze of the epoch by two This can also be done by using the toolbar icons 4 and M Specifying the number of seconds per epoch Open the Viewing options window from the Analysis menu gt Viewing options Enable the Waveforms tab This tab has three text boxes that specify the visible time range in each window one for the top waveform window one for the bottom waveform window and one for the trends window For each of these there is an associated button See complete test in one screen to compress the entire test on a single screen These adjustments can be applied separately to the top waveform window the bottom waveform window or the trends window However the time range in the top waveform window cannot be longer than that of the bottom waveform window and the time range of the bottom waveform window cannot be longer than that of the trends window Visualization settings Horizontal scale top waveforms window Seconds per screen Show full test test on screen Horizontal scale bottom waveforms window Horizontal scale trend window Seconds per screen 3600 Show full test on screen 534 740 MU2 e REV 1 05 BitmedLab User s Manual Using the Time toolbar Specify the duration of the epochs in seconds or mm s from the first list on the left of the Time toolbar The values of this list will appear in seconds or mm s depending on the software settings The screen must be previously calibrated for the mm s scale to co

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