RESmart Sleep Care Pulse Oximetry Airflow User Manual PDF
Contents
1. 19 SleepCare M Sleep Screener User Manual V1 1 iba PolvLogic Sleep Analysis Software for SleepCare BECScreener52 a File F View Vv Trend Auto Analysis Respiration Event R Windows W Help H eH RS MIR MR Be a re B 9 4 DK ab 240 oasa A Page 74 ca E Time 00 36 53 i Begin at 2010 0 A End at 01 42 23 3 Record length 0 A Sal 93 ioe 5902 lian ooh a E i A Max 8602 99 20 fag Mean Sa02 978 kl p c Q lt 4 Apnea 00 00 00 IV Longest Apnea D Y Longest hypopnea E3 Apnea index 3 E3 Hypopnea index EZA 36 A Respiration rate 15 E A Snore number 11 Total snore 200 Res Rate Snore index 118 E A Heart rate 65 7 Max HR 86 iv Min HR 50 ESS Mean HR 65 A Body position A Sleep stage S aa 00 00 00 01 00 00 Br Des Figure 2 5 Trend chart The basic functions on the page are Parameter browse 2 Parameter deletion 3 Event location 4 Print Analysis All the operations may complete through the menu choosing Regarding the commonly used operation besides the provided menu operation they may also be done by clicking on the toolbar buttons I Parametet browse AEN the record parameter according to the different time resolution of the tendency change Clicking The two buttons in the toolbar may enlarge and reduce the time axis for glances over the two buttons may make the cursor move forward and backward The2. 2 Navigating the icons via Shift button and select the intended function by pressing OK button 3 Setup allows changing some of the recording parameters see Figure 1 7 For example user 7 SleepCare Sleep Screener User Manual V1 1 can choose whether or not to save the flow data the snore data and whether or not to need an auto save or auto stop Several different lengths of time are available in the auto save menu for uset s satisfaction Thus the patient can preset it when he she is awake needing no further operation before falling asleep This device also has an auto stop function with a set of different periods of time after which the device may be triggered turn off by sensor removal That is to say it can stop recording when the sensors are dropped intentionally or by accident after the set time Users can also set an appropriate time for the Backlight using the Display s setup The Date Setup allows users to enter the date and time of recording see figure 1 8 While the cursor is at each settable item press Shift to decrease the value and OK to increase it Press and hold Shift to move the cursor to its left position and when the cursor reaches the left side it restarts from the right side of the other line OK button has a similar function but with its moving direction towards right Record When this icon is selected the device enters the recording page 5 Archives This icon offers information on the rec
3. 4 Fit the loop round the patient s ears and then back around the neck avoiding pulling it over the head SleepCare Sleep Screener User Manual V1 1 Figure 1 3 Illustration of Wearing the Cannula Move the slide towards the uset s chin until the cannula feels secure under the nose Fit the farther end of the cannula into the tubing end of the oral and nasal airflow unit and insert its data cable into the Flow COM left port at the main device bottom where the recorded data could be downloaded by a computer Put the oximeter data cable plug into the SpO2 right socket at the device bottom Insert the index finger into the pulse oximeter sensor Take note that the finger must reach the end of the sensor Figure 1 4 Illustration of Wearing the Pulse Oximeter Sensor 9 Wear the SleepCare main device around uset s wrist just like wearing a watch Adjust it for a comfortable position and fasten the belt to make it fixed To the oral and nasal airflow unit Figure 1 5 Illustration of Wearing the Main Device SleepCare Sleep Screener User Manual V1 1 Note The SleepCare device is watch style intended for screening sleep disordered breathing for adult patients only Recording Hoe Figure 1 6 Main Device Figurel 7 Setup Figure 1 8 Date Setup 1 Start the device by pressing and holding OK button the four icons Record Setup Archives and Tools are showing in the display screen
4. SleepCare Sleep Screener User Manual C 0123 SleepCare W Sleep Screener User Manual V1 1 Table of Contents IE idi ae ed iena foot i ab ja So poplu Ca data E 2 yy Airs COs and Contra A ONG eesi nne E logos ai jo 2 D E E TA 2 11611 ors ete A E E A E teed ten ceed Meee easier diet 2 COn 11 11011 rrr errr 2 EG A etre renter Kenn ater rum A AA ene ne een ene eee eee eee 3 Oh sik 108 amp Gros aus ciel a rere rere Terry Tete Tee E Tere eter ever rer ese A E E E rere rere 3 l 200 S A 4 nieepOite ID Pl a e E E OE 4 10186 11 E E A E E E E A E E T E 5 D a E e Sa 5 a a E a e A E A E E A ena E A A T 7 BE a DA A ey ere E 9 lim ora 1 tora U eee EE eT aap m mre ty nnn we eeT ANER 9 Conditions That May Affect The Sleep Gate 1486 9 DO ICS aca E A E N E E E E S 10 S O JO AP 10 O a OE A O E A A A A O A ated erence 11 Do e 11 B ne page ted nines ets E ce 12 LGM Ga GG err eT e TT Treen S a Teter Tre rr
5. Demo Data ID 002 Age 38 Sex Male Phone Address Date 2010 09 16 Time 00 22 00 End at 02 33 00 Duration 02 11 00 AHI 1 9 93 00 00 10 Occur at 00 31 15 SaO2 94 Apnea Sum Duration 00 00 33 of Total Sleep Time 0 41 Hypopnea Sum Duration 00 00 10 of Total Sleep Time 0 12 Apnea amp Hypopnea Longest Apnea 00 00 12 Occur at 00 48 10 5802 Longest Hvpopnea Apnea Sum 3 Hvpopnea Sum Apnea Index Hvpopnea Index 0 5 Snore Index 33 5 Legend Total 51660 Time Hypopnea Apnea Figure 2 10 Diagnosis Result Print Preview and Output When the waveform is in need of printing the waveform page should be activated to display Press button or click on preview from the File menu under this page to preview the present waveforms 27 SleepCare M Sleep Screener User Manual V1 1 File EMOEersezeritz DAT Mame Ds Date 2010 05 03 00 28 52 00 24 37 00 24 42 ASC Hospite Folysommogrepk Peport Fege of i Figure 2 11 Print and Preview of the Raw Data Waveform In other pages pressing R button or clicking on preview from the File menu may generate a window for preview options Select the intended report and press button the preview of report will be shown on the screen Eeport Selection I able Graphi Wile e Eiu Dame B laau nje 92000 Carding ltd Pressure Pule or IENI Figure 2 12 Print and Preview of the Report 28 SleepCare W Sleep Screener User Manua
6. System Contents 1 User manual 1 SleepCare main device 1 USB data cable 1 Pulse oximeter sensor 1 Oral and nasal airflow unit optional 1 Cannula optional 1 CD USB data cable User manual Main device Pia Pulse oximeter Oral and nasal airflow at i bo sensor unit optional eS ke i Cannula optional Figure 1 1 System Contents The belt on the main device is in accordance with the ISO 10993 1 ISO 10993 5 ISO10993 10 The finger sheath and cannula are CE marking approved indicating compliance to the Medical Device Directive 93 42 EEC Several accessories are available for using the SleepCare To ensure that the patient experiences a safe and effective use adopt only BMC accessories SleepCare W Sleep Screener User Manual V1 1 Svmbols These symbols are used on the SleepCare devices A Type B Applied part A Attention Consult Accompanying Documents IPX1 IPXI Drip Proof Vertical SN Serial Number of the product tual Manufacturer Authorised Reprisentative in the European Community C 0123 European CE Declaration of Conformity SleepCare Display Recording time 02 05 26 CPAP 0 0 Pulse waveform CPAP pressure Respiratory waveform Snore waveform Sp0 Pulse rate Figure 1 2 SleepCare Display e SpO2 Display Display the value in percent of oxygen saturation Pulse Rate Display Display the pulse rate in bea
7. the data can be transmitted to a computer for further analysis Besides SleepCare allows the analyzed data to be manually edited to remove the recording mistakes b Run the software and choose the File from the main menu select New to enter the communication interface Select USB port and click Connect Sleep Screener Online serial Port 0 USB C 0001 0002 o CONS COM4 COMS 0006 CONT COMS Figure 2 1 Sleep Screener Online c If connection succeeds the Connect button will be grayed And other originally grayed unavailable buttons will be available now After online with the computer see connection of SleepCare and computer SleepCare will automatically enter the communication status P P P y After the success of online click Replay button in Sleep Screener Online dialog box and the replay dialog box pops up Figure 2 2 16 SleepCare Sleep Screener User Manual V1 1 File Name Directory 0D SleepCare Data File Name BlpCare Data Type w Diagnosis Treatment Cancel C Figure 2 2 SleepCare Playback d The first content is data filename The second is data type Having the above two contents set up click OK and the pop up dialog box of patient information Figure 2 3 is then shown on the display screen Patient Information Patient Information ID Name Age Sex M f F Height cm Weight kg SBP DBP 0 Zi
8. Dips Short Interruptions and Voltage Variations on Power Supply Input Lines IEC 61000 4 11 Power Frequency 50 60 Power frequency magnetic fields Hz Magnetic Field should be at levels characteristic of a IEC 61000 4 8 typical location in a typical home or hospital environment Guidance and Manufacturer s Declaration Electromagnetic Immunity This Device is intended for use in the electromagnetic environment specified below The user of the Device should assure that it is used in such an environment Immunity Compliance Electromagnetic Environment Guidance Test Level Portable and mobile RF communications equipment should be used no closer to any part of the Device including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended Separation Distance Conducted 3 Vrms RF 150 kHz IEC to 80 61000 4 6 MHz d 12VP 80 MHz to 800 MHz Radiated 3V m d 23VP 800 MHz to 2 5 GHz RF IEC where P is the maximum output power rating of the 61000 4 3 transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range gt Interference may occur in the vicinity of equipment P marked with the following
9. Pulse Rate to see whether the pulse oximeter sensor is in good position for operation Conditions That May Affect The SleepCare Use e Environmental Fluctuating or flickering light may affect measurements Use of the SleepCare outside stated temperature and humidity specifications may affect measurements Contraindications Warnings and Cautions e Motion Excessive or rapid movement may affect measurements e Sensor Position Sensor position is critical for accurate SpO measurements All emitted sensor light must pass through the finger before reaching the detector Do not allow positioning such that some or all of the emitted light can by pass the finger as this will result in inaccurate SpO values While on the finger do not press the SleepCare against any surface and do not squeeze or hold the SleepCare The external spring provides the correct pressure on the finger additional pressure may affect measurements SleepCare W Sleep Screener User Manual Nail Polish V1 1 Fingernail polish may reduce light transmission which may affect SpO2 values In addition the following factors may degrade performance an arterial catheter moisture in the SleepCare a blood pressure cuff a finger outside the 0 3 1 0 size range an electrosurgical procedure venous pulsations an infusion line anemia or a low hemoglobin count cardiovascular dyes the SleepCare not at heart level Troubleshooting S
10. assure that it is used in such an environment RF Radiated Emissions Group 1 This Device uses RF energy only for its internal CISPR 11 Class B function Therefore its RF radiated emissions are very low and are not likely to cause any interference in nearby electronic equipment RF Conducted Emissions This Device is a battery operated device therefore these test CISPR 11 requirements are not applicable Harmonic Emissions IEC 61000 3 2 Voltage Fluctuations Flicker Emissions IEC 61000 3 3 Guidance and Manufacturer s Declaration Electromagnetic Immunity This Device is intended for use in the electromagnetic environment specified below The user of the Device should assure that it is used in such an environment Immunity Test Compliance Electromagnetic Environment Level Guidance Electrostatic Discharge 6kV 6kV Floors should be wood concrete or ESD Contact Contact ceramic tile If floors are covered IEC 61000 4 2 8 kV Air 8 kV Air with synthetic material the relative humidity should be at least 30 Electrical Fast This Device is a battery operated device and has no Transient Burst patient coupled cables nor I O cables which are longer than 3 IEC 61000 4 4 meters in leneth therefore this test requirement is not applicable Surge This Device is a battery operated device therefore these test IEC 61000 4 5 requirements are not applicable 12 SleepCare W Sleep Screener User Manual V1 1 Voltage
11. product To exercise the rights under this warranty contact the local authorized dealers or 29 SleepCare Sleep Screener User Manual V1 1 MANUFACTURER BMC MEDICAL CO LTD 5 F North No 2 Building No 9 Shixing Street Shijingshan District Beijing 100041 P R China Tel 86 10 51663880 Fax 86 10 51663880 Ext 810 EU AUTHORISED REPRESENTATIVE Shanghai International Trading Corp GmbH Hamburg Fiffestrasse 80 20537 Hamburg Germany Tel 0049 40 2513175 Fax 0049 40 255726 30
12. rer 12 Polylzovic Sleep Analysis Sottware or SleepGare Meuriad eni E aA S aa 15 SRE ta 15 S a EN E i e A A E TA 15 S IY A 15 Daa Re l EE E EEA A AEE EEE T E E ee ree 15 SE O E o a A a 16 Connection of SleepCare and C Qi pute tics iessicsssoszasdadarsaacosaseneiaiepsancewacnesiabeazasiens 16 Dar Tan 6X0 reer ee et eee eer er een Ce eee ee aT 16 Br A a 18 l 19 Open and Close the Data b a ene nnn rer rere ern eres emer ete ere rere ete 19 Display of Recorded Data and Analysis Res tisssscsesesssnsesvanicceivstiosesvarscasstatsnenseanseas 19 PPB yy ete caso sce sn A amcor E A A E A 27 E del i cal eee eee ert Terre tert Creer Trent CPrrerr creer eCrnrerr caterer E 29 o ee en ee ee ee re 29 ila be lal olosaammere rere Teer Ty mere metre Crm TT Necrrr ere ey vr erere rr rere erremrr Trerrs rererrr rrr ety 29 MAS 111 encase en nse A de set A E A 29 SleepCare W Sleep Screener User Manual V1 1 Device Warnings Cautions and Contraindications Warnings A warning indicates the possibility of injury to user or the operator of this device This manual serves as a reference Read and understand the entire manual before using the device Discontinue use if skin reddening or inflammation appears Do not smoke while wearing the BMC SleepCare Do not use USB data cable for communication to PC while the device is recording Only the USB data cable offered by BMC can be used for SleepCare communication to PC otherwise i
13. Auto Analysis If the respiration event or the snore is to be analyzed for a second time click or K Snore analysis in the toolbar ik PolyLogic Sleep Analysis Software for SleepCare BMCScreener52 aaa Z File E View V Trend Auto Analysis Respiration Event R Windows W Help H DF HRS we OOOOH OOH OOO Q gt H fios on Ae Lo25455 00000 Page 350 jil Trena Raw Data b Kespiration Event ep Report APH Length 3 48 s 02 53 55 02 54 25 WP 5 02 55 25 02 55 55 e Figure 2 7 Respiration Event Edit 25 SleepCare Sleep Screener User Manual V1 1 iba PolvLogic Sleep Analysis Software for SleepCare BECScreeners21 TA Z Fie E View V Trend Auto Analysis Respiration Event R Windows W Help H L D om Gl amp 1 6 160 G 6 8 B OC A e s 1 H man Page 479 jil Trena Raw Data Respiration Event Report 9491 91 95 95 97 96 94 94 93 93 83 93 93 93 64 94 95 95 95 95 94 95 94 93 93 894 94 95 95 93 93 90 69 90 90 20 01 92 22 02 9 93 94 93 93 93 No 17 HYP 40 5 No 18 HYP 13 5 03 57 07 04 01 07 TG a 0 04 52 08 04 50 13 04 48 13 04 47 47 04 06 59 04 06 46 03 59 31 03 52 49 03 16 21 03 15 57 lt C Parameter mt RES Event tz Desaturation Ready Figure 2 8 Respiration Event Analysis Form All analysis results are produced into concise reports after statistical analysis If the data
14. a management interface The screen shows the saved data and its related information in the hard disk Figure 2 4 The desired data can be easily found out by different orders in this page b First of all find out the route and catalog of the sleep data by using the Browse button Then all the files are listed with the information such as file name patient name serial number recording date record length person on duty and data version etc Click on the appropriate classification column according to which the files are ranged to alter the files order c In the lower right of the page are the function keys such as Open Backup Delete and Cancel Click the file name to select the file and then press the appropriate function key to achieve data playback data backup and data deletion d Selecting the cancel button in the lower right of the page can return to the main window of the SleepCare system Select Data File Demo Data 002 2010 09 16 02 11 00 Demo Data 001 2010 09 13 00 16 15 Backup Delete Cancel Figure 2 4 Select Data File Dialog Box 18 SleepCare W Sleep Screener User Manual V1 1 Data Plavback Under the sleep data management page select the sleep data file system will enter the data playback interface If the data have not been analyzed yet the prompt of auto analysis will be shown on the screen After opening the data file system will enter the data playback window There are the trend
15. adjust the time back and forth as to when the waveform shall be displayed with five seconds as a pace The two buttons 4 are used for page turning with each page length depending on the present speed of papet s walking For example if the current displaying waveform walks at 1 minute page it shows the waveform of either previous or next one minute upon each clicking on the icons TT The bar is a time vernier which could be dragged back and forth or clicked on to show a waveform in varying time ranges Moving the mouse cursor to the left or right edges of the waveform where the cursor changes to an arrow can make the waveform walking at the speed of 2 seconds page automatically The display contents can be located in accordance with the markings made by the editor or the various events in the analysis Refer to the event browse function and marking function in the following parts for details G Event browse a Breathing event All the breathing events are lined out with a series of colorful blocks in the graph with the serial number the type and the length of each one annotated nearby These breathing events are categorized into HYP and OSA which means hypopnea and obstructive sleep apnea respectively H He And a previous event or next event can be easily located by clicking the buttons b Snore The symbol X indicates a snore In this operation evaluations can be made to the sensitivity of sno
16. attery power Degree of Protection Type B Applied Part Degree of Protection Against Ingress of Water IPXI Mode of Operation Continuous Cleaning Caution e Never use abrasive agents alcohol chlorine containing substances acetone or other solvents to clean the recorder e Do not immerse the recorder the oral and nasal airflow unit or the pulse oximeter sensor in fluids and ensure that no fluids penetrate into the products e Do not attempt to disinfect or sterilize the recorder since this could cause unseen damage to the inside of the unit e The cannula is nonreusable dispose of it in accordance with local regulations 1 Turn off the SleepCare 2 Detach the oral and nasal airflow unit and the pressure cannula 3 Detach the pulse oximeter sensor from the SleepCare main device 4 Clean the following parts with a damp cloth and a mild liquid soap oral and nasal airflow unit pulse oximeter housing and pulse oximeter cable 5 Leave the cleaned parts to dry Disinfection Between patient uses the SleepCare should be surface disinfected in accordance with established clinical practice 11 SleepCare W Sleep Screener User Manual V1 1 Disposal Dispose of the device in accordance with local regulations EMC Requirements Guidance and Manufacturer s Declaration Electromagnetic Emissions This Device is intended for use in the electromagnetic environment specified below The user of the Device should
17. below according to the maximum output power of the communications equipment Rated Maximum Output Power of Separation Distance According to Frequency of Transmitter Watts Transmitter meters 150 kHz to 80 80 MHz to 800 800 MHz to 2 5 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power of the transmitter manufacturer Note 1 At 80 MHz and 800 MHz the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 14 SleepCare W Sleep Screener User Manual V1 1 PolvLogic Sleep Analysis Software for SleepCare System requirements for running the software 1 hardware requirements CPU2P3 1 0G memory2512M display resolution 71024768 hard disk 80G 2 software platform Windows XP Windows 7 Vista Setup Setup of the Software a Run the SETUP EXE of SleepCare in the installation CD and enter the setup page b Click Next to make the software auto install c Click Finish to quit when the installation is done Double click the new shortcut on desktop to launch the software Setup of Driver a Double click the USBXpressInstaller exe in the USB driver folder b Cl
18. button may open or close the display assistant window which is able to show each kind of parameter value at the present time where the cursor is Clicks with a mouse throughout the trend chart can drive the cursor to anywhere in it At the lower part of the trend chart lays a slide scale which can be dragged left and right to change the cursor position 20 SleepCare W Sleep Screener User Manual V1 1 The main part of the window shows the data analysis result trend chart The items in a top down order by default is the saturation of blood oxygen trend chart the apnea event length trend chart the respiratory rate trend chart the number of snoring trend chart and the heart rate trend chatt The horizontal axis stands for the elapsing of time with the time value marked above the horizontal axis 2 Parameter deletion Parameters that can be deleted in the trend chart include blood oxygen heart rate and respiratory rate Using the S Hi RS E in the toolbar may delete the invalid parameters If a certain part of the parameters during a period of time is to be deleted left click the mouse and drag it to select the intended part in the chart click the corresponding item from Trend of the menu bar It can also be done via the BWS BE BR Ej icons in the toolbar If only some points in the chart are to be deleted stay the cursor at the exact point and click the W HK RER K Ei button directly to erase them B Event locat
19. chart the waveform the diagnosis result the analysis report and other pages Open and Close the Data File a Multiple data files can be opened simultaneously in the main window of the SleepCare system For the method to open the data files please see the data file management patt b Opening a file may be failed if the file is being used c Select the intended file name in the Window menu to open the file d Clicking XI in the toolbar or select Close in the File option in the menu may close the current window of data file Display of Recorded Data and Analysis Result The data recording analysis result and statistical result are shown in 5 pages The order is the trend the raw data the respiration event the diagnosis result and the report The report includes the concise report the apnea analysis the SpO2 analysis and if the CPAP pressure is allowed it is also included The first chart displayed in the interface after the file is opened is the trend chart ill Ian and kaw Data E Respiration Event go Diagnosis Ep Report 2 2 other pages can be shown via b clicking the corresponding tabs above Trend Chart The trend chart demonstrates all the recorded parameters and analysis results during the entire recording time By demonstrating multiple parameters one may observe the different physiology parameters in the same period of time conveniently and may study the relationship between them easily
20. e saving thus can be relocated quickly upon later reopening Respiration Event This page has listed all respiration events and their correlations with the statistical data by form The respiration event list may sort according to different statistical items with just clicking on the corresponding statistical tags And the list will be shown in the intended manner Clicking on the list or using the fL kev on keyboard may choose any event in the respiration event list Click the corresponding button from the Respiration Event drop down menu to change the type of an event The displaying order of the list of events is not changed at the moment Above the respiration event list is the corresponding waveforms where all the respiration events are characterized by blocks of different color Right click on the event block select the corresponding option to revise or delete an event When the mouse arrow becomes draggable at the beginning or end of an event block drag it back and forth to shorten or lengthen the time of the respiration event Also a respiration event can be inserted by dragging a rectangular block in the waveform The list of respiration events below will make a change to be ordered by serial numbers accordingly Change the displaying page to a previous ot next one ot magnify and minify the time axis of O H il waveform by using the toolbar 24 SleepCare Sleep Screener User Manual V1 1 Respiration
21. ick Next in the prompt dialogue boxes the driver will be installed automatically This may take several minutes to finish c Click Finish when the setup is done d The dialogue box prompting found new hardware wizard comes when the USB data cable connected to a computer for the first time Click Next and wait for the installation finished Click Finish when it is done Note The found new hardware wizard comes only for the first time of a USB data cable connection The software can be directly used afterwards Data Reception Data reception is to transmit the recorded data to computer Software will analyze the data and then the operator can edit the results of the analysis to generate analysis reports Data receiving process is expressed as the following steps 15 SleepCare Sleep Screener User Manual V1 1 Start Software Firstly double click shortcut of the software icon on the desktop the system will enter the SleepCare system main window Connection of SleepCare and Computer In the power off status of the SleepCare connect one end of the USB data cable to the computer USB port and the other end to the SleepCare Flow COM socket and then turn on the SleepCare Enter Tools and choose Transfer Data USB Go on with operations of PolyLogic Sleep Analysis Software for SleepCare on the computer to make the connection Data Transmission a After recording
22. if no action is taken in this page SleepCare W Sleep Screener User Manual V1 1 Note While recording the OLED colorful display will be off after a set time since the last keystroke and it can be activated again by another hit on the Rey 8 Follow the direction of the 4 step to enter the recording page then press and hold OK button to start recording The timer in the up left corner begins to run Keep the device on and go to sleep 9 Press and hold both Shift and OK buttons at the same time to quit record process 10 Press and hold OK button to turn off the device Note Please put the batteries out of the device when the SleepCare is not in use for a long time Disassembly 1 Lower the slide from under the patient s chin and take off the cannula Take off the pulse oximeter sensor Unplug the data cables from the SleepCare main device Put the cannula off the oral and nasal airflow unit 3 Remove the batteries and discard according to local regulations Keep the SleepCare main device and the accessories appropriately under the instructions of medical provider Important Steps for Use It is of essential importance to have the OLED display screen checked to ensure an effective and correct recording before sleeping The red line indicating respiratory waveform must be fluctuating with the breathing rhythm while the yellow line which stands for the pulse fluctuation should also vary thereupon Check the SpO and PR
23. ion Click on the chart to make the cursor stay anywhere it is wanted to be Also clicking on the p gt icon in the parameter page of assistant window can bring the viewer to the very moment when this event took place For example clicking the EJ Min SalZ 93 item is able to point the cursor to the moment of the lowest value of oxygen saturation 4 Print Use La to print or print preview the charts or reports The printing function also goes well in other pages Analysis If the data analysis work has not been done when file is opened or some parameters are not correctly analyzed a second analysis is necessary after an adjustment to the data Select the corresponding options to perform the respiratory analysis and or snoring analysis The toolbar has provided three commonly used analysis shortcuts The buttons Br L call the respiration event analysis process and the snoring analyzing process respectively Also the analysis function works in other pages 21 SleepCare Sleep Screener User Manual V1 1 Raw Data This page can show all the recorded signals both in waveform and in numeric value By different walk speeds of paper this system can display in the current time scope all the recorded features in this page such as the recorded waveforms the record parameters as well as the corresponding analysis results and events ibd PolyLogic Sleep Analysis Software for SleepCare BMCScreener52 Beles Z Fi
24. l V1 1 Similarly selecting button in the toolbar or Print from File menu will show up the window for preview options The print work will be done after selecting the intended reports and i 0 setup S pressing the to change the printer settings Exit Program To back to Windows desktop just click File in the menu and click Exit or XI at the top tight corner Service Technical Support For technical support and before returning any equipment call BMC MEDICAL CO LTD at 86 10 51663880 Limited Warranty BMC MEDICAL CO LTD warrants that the SleepCare shall be free from defects of workmanship and materials and will perform in accordance with the product specifications for a period of one 1 year for main unit and three 3 months for all accessories from the date of sale by BMC MEDICAL CO LTD to the dealer During the warranty period BMC MEDICAL CO LTD will correct any defects in material or workmanship to conform to specifications free of charge BMC MEDICAL CO LTD reserves the right to replace the SleepCare with a comparable unit Shipping costs are the responsibility of the purchaser This warranty does not cover damage caused by accident misuse abuse alteration and other defects not related to material or workmanship BMC MEDICAL CO LTD disclaims all liability for economic loss loss of profits overhead or consequential damages which may be claimed to arise from any sale or use of this
25. le E View V Trend Auto Analysis Respiration Event R Windows W Help H jis gl x OSERSE MK HR ORA 00 e e el O 0 O Q lt A H fios 7 gt R Re Page 350 66 64 66 66 66 65 65 64 63 63 62 69 TI 68 69 64 64 64 64 64 68 65 63 63 96 96 96 96 96 96 96 96 96 96 96 96 96 97 96 96 96 96 96 96 96 96 96 g Sall2 ne VV VAV WV MAMMA Snore TAK 02 53 52 02 54 22 02 54 52 02 55 22 02 55 52 Ready HUM Figure 2 6 Waveform Display The following operations may be carried out in this page Print Modify display setup Modify paper speed Modify time display Event browse Event edit Mark function 1 Print File E Select in the menu or in the toolbar to print the analysis report 2 Modify display setup Move the cursor to a certain waveform and right click with mouse to access the pop up menu select the correct item to change the gain and color of the waveform 8 Modify paper speed This function is aimed at conveniently observing the waveforms of different types 22 SleepCare W Sleep Screener User Manual V1 1 H Apos i The tool in the toolbar can zoom in and zoom out the time scale to change the speed at which paper walks The range is from 8s page to 480 s page 4 Modify time display This page provides many kinds of methods for the operator to locate any period of time conveniently to observe the waveform and its parameters The two buttons are used to slightly
26. leepCare will not activate The red line keeps straight The cannula is not properly without fluctuation positioned or is not connected to the main device or is pinched Adjust the cannula and make sure it is connected firmly to the main device or contact the medical provider or BMC for a change The yellow line does not move The pulse oximeter sensor may Adjust the pulse oximeter sensor not in the correct position Specifications Oxygen Saturation Range U to 100 Pulse Rate Range 40 240 bpm Oral and Nasal 10 minute 40 minute Airflow Rate Range Wavelengths a Red 660 nanometers 3mw nominal b Infrared 905 nanometers 3mw nominal Accuracy a o SpO Accuracy 70 to 100 3 b Rate Accuracy the larger of 3 and Ibpm Resolution a SpOo 1 b Pulse Rate 1bpm Temperature a operating 10 5 C 40 C SleepCare W Sleep Screener User Manual V1 1 b storage Transpottation 20 0 55 C 8 Humidity a Operating 30 to 80 non condensing b storage transportation lt 93 non condensing 9 Atmosphere Pressure a Operating S60hPa 1060hPa b Storage 500hPa 1060hPa 10 Power Requirements 2 AAA Batteries of 1 5 VDC 11 Batteries Life approximately 16 hours of continuous operation 12 Dimensions 62mm X 57mmxX 21mm 13 Weight 70g main device without batteries 14 Max recording period for one measurement 10hours 15 Classifications per IEC 60601 1 Type of Protection Internally Powered on b
27. orded data The device allows 59 hours of accumulated recording time of full data But only the latest 8 pieces of data files can be seen through the OLED interface Enter Archives in the main menu and press OK the on line instant test scores ate summarized to the user instantly with acceptable accuracy and much convenience see figure 1 9 This is just a concise report Detail data can be reviewed by the PolyLogic sleep analysis software on a computer 6 Tools This icon offers methods of data transfer In addition to the traditional data transferring with USB communication port SleepCare gives users another choice of transferring data by blue tooth which 16 available depending on the customization The data entries can be viewed when entering the data transferring page please refer to PolyLogic Sleep Analysis Software for SleepCare in this manual for details Press and hold both shift and OK buttons to quit this data entry page About shows device information such as the version available memory battery power and the current time see figure 1 10 Press any key to quit SS bet pe og pe ee sok A LETE faael ration Summary Total Tine 00 01 17 APH ua i walid Tiwe 00 00 4 APH Tiea 00 00 00 Bin Spi 81 PHT H Bay Spig ST HF ca lead a Sn p Gran opLE ie OO0 0 0 Ver 1 13 02 00 Battery Pover E 12 07 2010 1 Figure 1 10 About 7 The device automatically turns off in one minute
28. p Code ddress Phone Watch Date 2009 m 2 w 25 o Current Time 14 45 53 Being at 04 H a M Figure 2 3 Patient Information Input e Recording start time is set by system at the beginning of the recording time which is confirmed by the internal clock If the SleepCare clock is not correct modify it in the above login screen The recording end time defaults to 12 hours after the record start In fact in the process of data transmission the system can automatically identify the actual end time of record SleepCare will automatically stop after data transmission is finished So need not to change the recording end time in normal situation f Enter patient information one by one g When the login information input is finished select OK Then computer begin to receive the recorded data When data transfer is finished the system returns to communications dialog 17 SleepCare Sleep Screener User Manual V1 1 box At this time select disconnect or return in the dialog box SleepCare will then automatically exit from the communications status h If another device is intended to connect to the computer repeat the process of data reception If no data transmit is needed click back button in the communication to return to the main menu Data File Management a In the main window of SleepCare system choose Open in File of menu bar the system will enter the sleep dat
29. recording has contained the CPAP pressure a CPAP pressure report is also included iba PolyLogic Sleep Analysis Software for SleepCare BECScreener52 9 File F View v Trend Auto Analysis Respiration Event R Windows W Help H D saaemxiBjaoM 60616 KO D gt H ps Jon R Ea 03 59 07 Page 479 jil Trena Raw Data E Respiration Event e Report Sa 91 91 95 95 97 96 94 94 93 93 93 93 9393 94 94 95 95 95 95 94 95 94 93 93 94 94 95 95 93 93 90 89 90 90 90 91 92 92 92 93 93 94 93 93 93 No 17 HYP 40 No 15 HYP 13 5 03 57 07 04 01 07 IT 8 3056 04 52 08 04 50 13 04 48 13 04 47 47 04 06 59 04 06 46 03 59 31 03 52 49 03 16 21 03 15 57 lt if Parameter r4 RES Event ti Desaturation Ready Figure 2 9 Analysis Report 26 SleepCare M Sleep Screener User Manual V1 1 Diagnosis Result The conditions and results of examination can be reached by selecting the corresponding items in the drop down menu Both English and Chinese can be inputted in the suggestion field All the above reports can be printed out PolyLogic Sleep Analysis Software for SleepCare 06002 IE File F View v Trend Auto Analysis Respiration Event R Windows W Help H D aw RG gi Be SS Ke B Br B B Be 10 Oe Sle gt A H 1305 R re Cozzo Page 1 a E arte JE ein ra S mee JE oe La SleepCare Report BMI 25 9 File Demo2 DAT Height 171 Weight 76 Name
30. ring threshold and it can be adjusted by modifying the threshold of snoring identification and therefore changing the number of snores 6 Event edit The type and length of breathing events can be revised and every event can be inserted or deleted in this page For changing the breathing event type or deleting any event right click on the event and select the corresponding item to continue 23 SleepCare W Sleep Screener User Manual V1 1 For changing the leneth of a breathing event firstly point the mouse cursor to the beginning or the end of the block of event when the mouse arrow changes into a draggable state Then drag the left or right edges to change the time of beginning and end For event insertion left click mouse and drag it to form rectangular block on the waveform when a menu pops up demonstrating the length of this block Select a corresponding event type to generate such an event Marking function When the operator feels particularly interested in any recorded part and intends to relocate it on his next opening of the file he may use this marking function attaching different marks to different areas of interests Three symbols A B and C are provided in this function And the texts A B or C are shown at the bottom of waveform The A WA Ae B 8 Be C C in the toolbar is used to make a mark or search for the previous or next mark These markings can be kept while fil
31. symbol 13 SleepCare W Sleep Screener User Manual V1 1 Note 1 At 80 MHz and 800 MHz the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Field strength from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the Device is used exceeds the applicable RF compliance level above the Device should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the Device Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Recommended Separation Distance Between Portable and Mobile RF Communication Equipment and the Device The Device is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled The user of the Device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communication equipment transmitters and the Device as recommended
32. t may cause danger to the operator or the patient Do not use the SleepCare device in situation where alarms are required The SleepCarelM device has no audible alarms Cautions A caution indicates the possibility of damage to the device This device is to be sold by or on the order of a physician Avoid exposure to sources of direct airflow such as fans during recording Avoid using this device in an MRI environment or in close proximity to a high EMI emission source Do not attempt to take the main device apart No user serviceable parts are inside Do not immerse the main device in water If any unexplained changes are noticed in the performance of this device if the device is dropped or mishandled if water is spilled into the enclosure or if the enclosure is broken discontinue use and contact BMC Contraindications Depending on the skin condition or general state of health the patient may experience sensitivity to the wrist belt or the self adhesive finger sensor Discontinue use if a reaction to the skin contact materials happens SleepCare W Sleep Screener User Manual V1 1 Intended Use The SleepCare device is indicated for the screening of sleep disordered breathing It records the following data patient respiratory oral and nasal airflow snoring blood oxygen saturation pulse rate and CPAP pressure The device uses these recordings to generate a report for screening or for further clinical investigation
33. ts per minute Note 1 The sampling rate of the SpO2 signal is about 30Hz and the update rate of the frame is 1H2 So even there SleepCare W Sleep Screener User Manual V1 1 are some filtering methods to process the SpO2 data it will not delay for a relative long time to the displaying data 2 The waveform of the pulse is normalized so that the software can adjust the amplitude of the displayed waveform However the SleepCare does not store the waveform data just keeps waveform updating to give the implication of the detector in working state Recording Time Show the length of recording time e CPAP Pressure Display the direct component of airflow pressure Pulse Waveform The yellow line depicting the artery pulse feature Snore Waveform The green line indicating the occurrence of a snore e Respiratory Waveform The red line reflecting user s respiration fluctuation Instructions for Use Fitting 1 Remove the SleepCare main device oral and nasal airflow unit pulse oximeter sensor and the two batteries from the package 2 Open the battery door at the left side of the device Insert two new AAA batteries following the polarity markings indicated on the battery door Carefully position the battery door and gently get it into place 3 Fit the oral and nasal pressure cannula so that the two small open tubes point towards patient s nostrils while the third open tube pointing towards his her mouth
Download Pdf Manuals
Related Search