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Acumen 7 User Guide

1. CA WT 63 Step 8 Final screen showing progress on scanning files When scanning is complete you can see that data in the chart formats T Scan files Desaturabon Analysis Respiratory Evert Analysis Leg Movement An tysis ACCE Analysis Snore Analysis Save Data Q CURATIVE ERASE CHIP DATA NEW TITLE NEEDED Step 1 Select Erase Chip data from File tab Note The device can store 49 records When the amount of records exceeds 49 new records will be saved over the oldest records Mew Record Ga Open Record Import Raw Data Ctri 1 Download CtrieD Close Ecan File File Utility ip Prt Cuire Print Preview Pring Setup 1 Di BackupiMy Documents User Manuals New Versionl12345112345 L112355112112 CAW 2 Ori Backup My Gocuments User Manuals Mew Version301008080002 201008080002 0847 3 Di Backupi My Documents Manuals Mew Versionlsaalaaa CAM 4 Di BackupiMy Gocuments User Mandals New Version 201008060001 201005060001 TAW amp BriBackupiMy Cocuments User Manuals Mew Versionl12345112345 Ext 64 Step 2 Click Erase Step 3 Check that you do want to erase the data Erase Whole Chip Data Erase Whole Chip Data Information 1 23 re you sure to erase whole chip data there is no way to get data back after erasing process is done ve Q CURATIVE SCANN
2. Mixed Apnea MSA Obstructive Hypopnea OH Central Hypopnea CH _ 49 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 4 SNORE EVENTS This is an example of a SNORE waveform graph been marked with an event SNE As there is only 1 type of SNORE event there is no need to use different colors so these events are displayed in Red as standard 78 CURATIVE To delete an event single click on the right mouse button and select Delete Event SNORE ai Ld il Lu eon Properties Barb POWER EVENTS This is an example the power waveform graph been marked with 32 21 03 04 15 event 100 As there is only 1 type of power 2 event there is no need to use different colors so these events are 19 CURATIVE displayed using blue To delete an event single click on Power 1 1 03 3 2 2 1 0 9 0 4 1 5 the right mouse button and select Delete Event 100 Delete Event Properties e e DESATURATION EVENTS 80 CURATIVE This is an example of a SpO2 100 waveform graph been marked with 3 Ee es 7 events Desaturation BodyF os Epoch 123 4 4 AT AT AT Length 40 0 s As there is only 1 type of oxygen 12 BodyPos Supine s Min 5 02 83 96 desaturation event there is no need to use different colors so these events a
3. R n CERCARE eee mad the driver Install this driver software anyway software Only install driver software obtained from your manufacturer s website or softwa disc Unsigned software from other sources may harm your computer or steal i information EEE EEE ETE PETTEE ET ETTE EET TETTE TETTE EET ET ETE ETE EEE ET EET PETE ETTE B amid sca ERR dn Please select t h e secon d item ess Install this driver software anyway 41 CURATIVE Step 7 If the driver aes v Update Driver Software Curative Medical Acumen 7 Windows has successfully updated your driver software software can b e S u ssfu ly Windows has finished installing the driver software for this device Curative Medical Acumen 7 installed gt windows will prompt that Windows has successfully updated your driver software 42 CURATIVE INSTALL USB DRIVER IS DRIVER SOFTWARE CANNOT BE SUCCESSFULLY INSTALLED Step 1 If i Step 2 Driver Softw _ Found New Hardware Unknown Device ice dri i 5 ver softy was n fully ir the driver Device Device driver software was not successfully installed Windows encountered a problem installing the driver software for your device Please consult with your device manufacturer for assistance getting this device installed software driver Unidentified Device Failed Windows found driver software for your de
4. 56 Q CURATIVE IMPORTING DATA FROM FILE LOCATION Step 1 Select Import Data from File Location from File tab File Option Window Help New Record pb Open Record 22 Import Raw Data from File Location Download Data from Device Erase Chip Data Close scan File File Management d Print Ei Print Preview Print Setup 1 Documents Acumen 7 Demo Datal5554446661555444666 CAW Ext Step 2 Browse to find a location where the data can be saved Click Next of 7 Import Raw Data from File Location Browse a E Records Information Save to Directo Documentsi cumen 7 Demo Data for Folder iL My Documents My Can puter S s Local Disk EH Local Disk Di r Local Disk E s Local Disk EE 1 Shared Documents Administrator s Documents My Network Places ERE IA Arman KEP rhae EE Disk information LA 8289 8 hours Prior Cancel 80 B Ne 4 4 b CURATIVE Step 3 Input patient information as directed in Create a New Patient T Import Raw Data from File Location Patient Information Name First Name D T ofBidh lg Last Name Female 1 171900 9 feigh Height Handedness
5. 79 70 88 60 55 99 94 ag 54 79 74 69 54 59 92 Time minutes 287 5 121 5 42 5 12 5 5 5 6 0 0 5 0 0 0 0 BMI 0 0 Height 0 0 in Weight 0 0 Ib Date 8111 2010 Stop Time 05 11 30 Percentage 60 1 25 4 8 9 2 6 1 4 1 3 0 1 0 0 0 0 2 2 3 Physician Technician Record Mui 123123 Scored By 5a02 Time s 02 Index F Hr 0 0 38 0 70 6 72 0 46 2 90 0 0 0 0 CURATIVE SAVING AND PRINTING REPORTS Reports can be saved and printed using Microsoft Word It is important when saving reports to ensure they are saved to a known location such as My Documents SLEEP DISORDER ANALYSIS The sleep disorder analysis plots allow you to look at related sleep data to help with the diagnosis of sleep disorders There are 3 Sleep Disorder Analysis plots e Respiration Event Analysis e Oxygen Saturation Analysis e Snoring Analysis VIEWING SLEEP DISORDER ANALYSIS PLOTS Step ie Sleep 1 9 0 0 USB 123123 Step 2 7 Sleep 1 9 0 0 USB 123123 Select View Reports Option Move Window Hep Choose view Reports Option Move Window Help TINT 17 mukitrend Plots 3CEHER mulifrend Plots TIE ERI ET CGU nae xs ead KST Disorder 22 Sleep Disorder Analyses Apnea Hypopnea Event Analysis the 3 Sleep D
6. gt Power Reports File Edi View Insert Format Reports Window Help NEM CURATIVE RESPIRATORY EVENT SUMMARY REPORT Step 3 The respiratory summary report View provides analysis on Name BMI 0 0 Physician Patient ID 123123 Height 0 0in Technician Respiratory Bex Male Weight 0 016 Record Nui 123123 The respiratory event trend Age 110 Date 8 11 2010 Scored By Event Start Time 22 00 00 Stop Time 06 11 30 plot respiratory event Total Record Time 491 5 Summary Breath Event Distributing Plot Report distributing plot body position on 2200 22 50 lul trend plot apnea hypopnea Em and the longest apnea time during sleep the average apnea P 01 55 03506 09 06 50 04 59 LER BIET number of apneas apnea index WEN ME 1 MO I HT MU time the total time and total iii and disorder index On So 030609 i E ui 5 AEG 2 452 1224 0 20 q00 Status The Longest Apnea Time Seconds 94 3 eum mam Fm m mum TR dann FIT um omm Ir 91 CURATIVE SPO2 SCORED SUMMARY REPORT Step 4 The SpO2 summary report View provides analysis on SpO2 The SaO2 Trends SaO2 Scored Distribution O2 distribution and Summary a SaO2 scorecard Report Name Patient ID Sex Age 123123 M le 110 Start Time 22 00 00 Total Recording Time 491 5 amp aO02 Trend Plot Hors 02 95 90 85 80
7. 0 00 x 0 00 om Let f Ib in C Right Comments 01 Prior Next gt Cancel Step 4 Browse to find the source file that holds the data you are importing Important imported file must be in Rawdat or DAT format 58 7T Import Raw Data from File Location Source file Destination fi DABackupWy Documents Acumen 7 Demo Data 10000112 Read lose CURATIVE Step 5 Step 6 Import Raw Data from File Location select the Once you Source file Documentsl cumen 7 Demo Data 0000112 data you have Destination fil 1Backupiy Documents acumen 7 Demo Datal0000112 9000 want to selected import and your data to click import click Open Read to import the data Read Close 2 Read Close e 59 CURATIVE DOWNLOADING DATA FROM THE DEVICE Step 1 T Sleep 1 9 0 0 USB 10001112 BE Option Window Help pp Open Record Download Open Recor r Import Raw Data from File Location 1 D evi ce Erase Chip Data Close from File __ PI i tab Le File Management Print Chr P Bi 8 Print Preview 2 Print Setup 1 D Backup My Documents cumen 7 Demo Datal5554446661555444666 CAW Step 2 The next screen will show the records from the Acumen 7 Select the record that you want to download 60 Record List 5
8. CURATIVE APPENDIX A TERM DEFINITION REPORT ANALYSIS CONTENT e Report content is between Light out and Light on SLEEP PARAMETERS e Light out the clock time of the first page of the stage e Light on the clock time of the last page of the stage RESPIRATORY PARAMETERS e Sum total of apneas the total number of obstructive OBS central CEN and mixed MIX apneas occurring during total sleep time TST e Subtotal of apneas the total number count of obstructive central and mixed apneas between Light out and Light on e Respiratory distress index RDI respiratory distress index is defined as apneas and hypopneas divided by the total sleep time events per hour and hypopneas count TST minutes x60 e Average sleep incubation period The first sleep phase from Light out e Average REM incubation period The first REM phase from the beginning of sleep e Number of REM phase there is only one REM phase in each phase of sleep including the total number of phases of sleep containing REM e Average all phases of sleep results to calculate the average value OXYGEN DESATURATION PARAMETERS e Based on the transducer parameters set for the user arterial SpO2 saturation degree is lower than the total sum ft count ACUMEN 7 report view program displays the following SpO2 saturation degree percentage lt 90 lt 80 lt 70 lt 60 lt 50 lt 40 and 30926 e The longest respiratory events and min c
9. Hp Disk drives Display adapters 4 j System Tools b Task Scheduler gt fd Event Viewer g Shared Folders gt Local Users and Groups gt Reliability and Performz Device Manager Storage gt Disk Management gt Services and Applications H Keyboards ce Monitors 9 09 Network adapters Processors m i System devices USB Root Hub USB Root Hub USB Root Hub USB Root Hub 2 9 USB Root Hub tli DVD CD ROM drives t 85 Human Interface Devices IDE ATA ATAPI controllers 2 7 Ports COM amp LPT 2 Mice and other pointing devices 8 ET Sound video and game controllers Storage controllers E Universal Serial Bus controllers y Intel R 828016 ICH7 Family USB Universal Host Controller 27C8 g Intel R 828016 ICH Family USB Universal Host Controller 27C9 g Intel R 828016 ICH7 Family USB Universal Host Controller 27CA Intel R 828016 ICH Family USB Universal Host Controller 27CB g Intel R 82801G ICH7 Family USB2 Enhanced Host Controller 27CC Device Manager More Actions 47 Acumen 7 Q CURATIVE Step 10 Open Control Panel Programs and features we can find Acumen7 USBbDriver Turn Windows features on or item in the list such as off Control Panel Home View installed updates the follow picture Uninstall or change a program To uninstall a pr
10. Position the sensor at a different site e g earlobe Ensure that the sensor is safely attached to the Acumen7 Check the sensor for any visible signs of deterioration Contact Customer Support Reduce patient motion Reposition the finger or insert a different finger and keep the sensor 23 CURATIVE SpO2 display being detected The finger was removed from the Sensor The 7 is not functioning CONNECTION PROBLEM USB CABLE Problem Possible Cause Unable to connect to device Used error USB cable Unknown device USB driver is not installed Communication error Please The cable and device loose check the device side and USB connection cable connection is good DOWNLOAD DATA USB CABLE Problem Possible Cause Communication error Please The cable and device loose check the device side and USB connection motionless for at least 10 seconds Position the sensor at a different site e g earlobe Reinsert the finger and keep the sensor motionless for at least 10 seconds Turn the unit off check all connections and retry Contact Acumen7 Customer Support Possible Solution Check the cable make sure that it is a USB cable Install the USB driver Please fix the connection between cable and device Possible Solution Please fix the connection between cable and device 24 CURATIVE cable connection is good Can not read device records Device connection error P
11. START UP To start the Acumen 7 software either select the shortcut on your desktop or if Acumen 7 does not have a shortcut on the desktop select Start menu Programs Curative Medical Acumen 7 MAIN TOOLBAR The main toolbar provides instant access to the most commonly used functions of the software Da amp 30650 25 lt lt 979 gt A New Record Show Video Time Periods Sleep stage Open Record View a Multi Trend Plot Navigation keys Jump to Event 49 CURATIVE Print Scan File Light on and Light off EVENT SCROLL BAR e t 4 1 The event scroll bar can be used to scroll from one event to the next You can scroll between apnea events hypopnea events and desaturation events STATUS BAR 8 ER Record Time 01 01 30 Epoch 124 The status bar at the bottom if the screen displays the recorded time and the period of time SETTING THE PERIOD LENGTH 30 60 2m 5m 10m There are 5 different time period lengths that you can view the data in 30 seconds 60 seconds 2minutes 5minutes and 10minutes You can adjust this on the toolbar LIGHT ON AND LIGHT OFF Q 9 The Light on and Light off function on the toolbar is used to indicate the time that the patient was asleep during the data collection By using Lights on and Lights off you can eliminate data that was collected when the patient was awake 50 CURATIVE CREATE A NEW RECORD step 1 BT Step 2 Select
12. User Manuals File tab vm stored ue records rie Print Print Preview Select a file Print Setup and click OK 1 Di Documents Lser Manuals New Version 123954 12345 _ 112355 1214444444441444444444 CAM 2 Dr BackuplMy Documents User Manuals New Version 12345 12345_L412355 20 1008090001 201008090001 CAW 3 Documents Liser Manuals New Versionl12345112345 1112355112112 CAW 3 Di Backup My DocumenbslUser Manuals New Version 20 1008060002201 000060002 C AW 5 D BackupiMy DocumentsjUser Manuals New Versionaaat aaa CAW amp O BackupiMy Documents User Manuals New Version 201008060001 201008060001 fi eg Directory D 1Backuplkly Documentsiser Manuals New Version 71 Q CURATIVE Step 3 If the file has not been scanned previously then you will asked whether you want to scan the file Question Do you want to Scan D Backup My Documents User Manuals New Versioniz010080600021201008060002 LIS006008001500600800 Step 4 If the file has already been scanned you will be reminded that it has You will then be asked whether you would like to scan the file again Scan List Question 12 CURATIVE Acumen 7 T Scan files Scan List process Ven E To pp peo arro EIN AE Main process 73 Q CURATIVE REVIEWING RECORDED DATA To review recorded data select the file that you wis
13. driver software compatible with the device and all driver software in the same category as the device Windows can t verify the publisher of this driver software Don t install this driver software You should check your manufacturer s website for updated driver software for your device aeu EUER AUI UENIT YT EE TE TT TVET sd TEST gt Install this driver software anyway Only install driver software obtained from your manufacturer s website or i disc Unsigned software from other sources may harm your computer or steal information 14422 4221221132 See details CURATIVE Step 8 If the driver software can be successfully installed windows will prompt that Windows has successfully updated your driver software software anyway 1 Update Driver Software Curative Medical Acumen 7 Windows has successfully updated your driver software Windows has finished installing the driver software for this device Curative Medical Acumen 7 46 CURATIVE Step 9 If the driver software has successfully installed you will find Curative Medical Acumen7 in Computer management Device Manager Universal Serial Bus controllers nammnputer NManadoement 1 E ga KING PC mi Computer
14. is used in such an environment IEC 60601 test Compliance Immunity test level level Electromagnetic environment guidance eve eve Electrostatic 6 kV contact 6 kV contact Floors should be wood concrete or ceramic tile If floor are covered with synthetic discharge ESD material the relative humidity should be at least 3096 The manufacturer needs to t8 kV air 8 KV air recommend the ESD precautionary procedures to user IEC 61000 4 2 Power frequency Power frequency magnetic fields should be same levels with characteristic of a 50Hz magnetic field typical location in a typical commercial or hospital environment IEC 61000 4 8 Guidance and manufacture s declaration electromagnetic immunity for EQUIPMENT and SYSTEMS that are not LIFE SUPPORTING The Acumen 7 Polysomnograph is intended for use in the electromagnetic environment specified below The customer or the user of Acumen 7 Polysomnograph should assure that it is used in such an environment Immunity test IEC 60601 test Electromagnetic environment guidance 27 CURATIVE Conducted RF IEC 61000 4 6 Radiated RF IEC 61000 4 3 3 Vrms 150 kHz to 80 MHz 3 V m 80 MHz to 2 5 GHz 1 Vrms 3 V m Portable and mobile RF communications equipment should be used no closer to any part of the Acumen 7 Polysomnograph including cables than the recommended separation distance calculated from the equation applicable to the freq
15. nd Erase Chip Data Print Erin m p Print Preview Print Setup 1 Dr Backup My DocumentsiUser Manuals New Versionl12345112345 L112355112112 2 Di BackuplMy DocumentsiUser Manuals New 10086600021201005060002 CAW 3 DiJBackup Mv DocumenksiLIser Manuals New Versionjaaal CAM 4 DrlBackupiMy DocumenksiUser Manuals New Versionttz 100806000 1120 1002060001 5 DrBackupiMy DacumentsiLlser Manuals New Version 1234511 2345 CAW Exit 67 Step 2 Select Files to delete or backup from File list or Database list You can browse different directories to find files T Backup Delete File List Database List Patient ID Date of Birth 2010 L Documents ts er Directory DiBackupiMy Dacumentsiliser Manuals New Version Browse Backup Delete Cancel CURATIVE PRINTING Step 1 For Reports omen Move window Heb Step 2 The Mew Record f u i D TEE a quick gj Open Record Print RAE MA ANANAS t Import Raw Data ian hA Ks asi JL Ts m ES pri nt selec SST zu review E heel M i VARA n Print Erase Chip Data can zoomed TUE Close in and out To view s File a n d b e the Print Prine Preview saved as a document PESE picture b efo re 1 Back
16. off DATA DOWNLOAD Connect the USB data cable or the RS232 cable to the appropriate PC port and Acumen7 port To enter the data download mode of the Acumen7 press the On Off button for 1 second until the green power light is switched on If the orange status light is also switched on the device is in data collection mode CURATIVE LED DISPLAY FUNCTION DESCRIPTION Function Switch Power off Press 2s Power on Press 1s Data collection mode Press 1s Recording data Power LED No display Display in green Display in green Display in green 20 Status LED No display No display Display in orange Flashing in orange when Pulse Oximeter is detected Display in orange when the Pulse Oximeter is not detected CURATIVE COMMON PROBLEMS ANALYSIS AND TROUBLESHOOTING AIRFLOW SIGNAL NASAL CANNULA Problem Possible Cause Unable to obtain a nasal The cannula is not properly cannula signal display on the positioned bar graph The cannula is not tightly connected to the main device The cannula is pinched kinked Consistent invalid or The cannula is not secure on the incomplete measurements head with ERR being displayed The patient is a restless sleeper and the nasal prongs are becoming displaced SNORING SIGNAL SNORE MICROPHONE IN RECORDER BOX Problem Possible Cause No snoring waveform Snore Microphone may fail Possible Solution Adjust the cannula so the nasal prongs rest just in
17. rate the average of the maximum and minimum values within each clip the average of maximal plus min 2 is taken to calculate this value the clip with the maximum or minimum value of zero is not counted Trend plot heart rate heart rate trend plot is based on the average of the maximum and minimum values within 30 seconds of each clip The clips with the minimum value of zero and clips with no data are not included Patient information the first part of the report consists of the patient information medical history and remarks These fields are generated with entered information during recording The demographic data of the patients should be entered in a consistent form because this information will be used to generate normalized results and intersect the patients statistical data Other fields are used to store the detailed information of the laboratory RESPIRATORY INFORMATION 98 CURATIVE e This part lists the summary information of respiratory events including apneas and hypopneas Apnea table lists the total number of apneas listed according to event types obstructive mixed and central apnea This table will be further classified according to body positions Rapid Eye Movement and Non Rapid Eye Movement If there is no body position information in the file or body position is not defined For example the sitting position this body position will be listed as unknown Hypopnea table will list the central and obstructive hypopneas
18. sensors are attached to the chest and abdomen belts The chest and abdomen belts should be adjusted so they transmit the data effectively If the belt is worn too loosely the signals received from the sensors may not be stung enough to transmit accurate data The Oximeter Probe can be clamped onto any finger Use adhesive tape to secure the probe to the finger as to avoid the patient subconsciously removing the probe The Nasal Cannula is placed onto the nose of the patient It uses pressure conduction mode to sense and respond to the pressure inside the nose and mouth Be careful not to let fluid enter into the cannula CURATIVE Note Before turning the device on all equipment must be connected properly and be worn by the patient USAGE OF 7 SLEEP DATA COLLECTION e Open the battery compartment and install two AA batteries e Ensure that all the sensors are connected properly e use the sleep data collection mode of the Acumen7 press the On Off button for 2 seconds until both the green power light and the orange status light turn on e The system will automatically detect readings of SpO2 from the pulse oximeter within 5 10 seconds When 5 2 readings are detected the orange status indicator light will flicker slowly with an interval time of 1 second e To switch the Acumen7 off when the device is not in use press the On Off button for 2 seconds until the status light and the power light are
19. 08 fo 50 8 ap 5 85 Q CURATIVE Body Position Plot This plot displays the body position of the patient during sleep The vertical axis shows the body postion of the patient e S supine position e L left recumbent position e P prone position T Body Position Plot e R right recumbent position L horizantal axis displays the length of time the patient has been asleep in hours 86 CURATIVE VIEWING DIFFERENT PERIODS OF THE DATA When viewing the Multi Trend plot or Single plots there is a black vertical index line on the left hand side that indicates the time period of data you are viewing on the plot The time period the plot shows depends on the time period you view the data in before viewing the plot For example if you view the data in 2 minute periods then the interval periods on the plot will be 2 minutes To move the index line you can use your mouse either using point and click or the scroll Alternatively you can use the arrow keys on your keyboard 87 Q CURATIVE VIEWING AND EDITING PATIENT DATA Step 1 Select Patient T Sleep 1 9 0 0 USB 201007190098 VE Reports Option Move Hep S ER MuliTrend Plots S Single Plots gt 1 K 01 Sleep Disorder Analyses Information from View tab Event Lists d ABDM Log Event List Patient Information 7 e CHTM Step 2 There are 5 tabs that are r
20. 4 FS 2000 10 47 I 15 2010 11 22 7 15 2010 3 13 PM M AS20010 23 26 98 5 2010 11301 B S z010 11 01 BESDID 12 x3 PM BAND 1503 lt 1203 SE B 5 2010 1413 PM 11719008 om 1 2 1900 amp Male 1 1 1900 8 Step 3 Record Lit alle Step 4 TENE ISH Choose the location 3i M 7 14 2010 5 08PM 201008090 7 15 2010 AM Download 7 15 2010 11 22 AM 201008060 i 2 15 2010 3 13 PM TITSI2010 3 26 to begin 872010170144 5 2010 1101 that you 4 8 5 2010 12 33 PM the data MIRO 12 33 PM want to download download the data to Fill in any cmn taste ee anses s 2226 Height wage Jena Teher ammet eme MISSIN 5 ETT information Click done 61 CURATIVE Step 5 Wait Eum da for data to download When the download has finished click OK OT TT TT 62 Step 6 Select the record and click Open File record Lizi teberil Downed progress and davmlead file list 7 14 2010 5 08 CURATIVE Step 7 Once the file is open you will be asked if you want to scan the file Select Yes and scan the file to process the data Liest k 2 you want bo Scan
21. 4 CURATIVE Acumen 7 User Guide CURATIVE Attention It is necessary to read the user manual carefully before first use the device Keep the manual in a safe place so that you can refer to it whenever necessary MANUFACTURER EU AGENCY Curative Medical Technology Inc Curative medical devices GmbH No 9 PeiYuan Road New District Suzhou 215163 P R China Blasewitzer Str 41 01307 Dresden Germany Telephone 86 0512 69217308 Phone 49 351 450 4500 Fax 86 0512 69217338 Fax 49 351 450 4511 E mail info curativemedical com CURATIVE CONTENTS SYMBOLS SYSTEM INTRODUCTION USAGE SCOPE OF APPLICATION CONTRAINDICATIONS CAUTIONS WARNINGS PRODUCT COMPONENTS AND DESCRIPTION PRODUCT COMPONENTS PRODUCT AND ACCESSORIES SPECIFICATION OF DEVICE SAFETY INSTRUCTIONS AND CLAIMS HOW TO USE SAFELY LIABILTY CLEANING AND MAINTENANCE CLEANING THE ACUMEN7 11 11 12 13 14 14 15 15 15 CURATIVE MAINTENANCE 15 DISPOSAL 16 QUALITY WARRANTY ERROR BOOKMARK NOT DEFINED SYSTEM INSTALLATION AND USAGE 17 SYSTEM CONNECTION 17 ACCESSORIES 18 CHEST AND ABDOMEN EFFORT SENSORS 18 OXIMETER PROBE 18 NASAL CANNULAR 18 USAGE OF ACUMEN7 19 SLEEP DATA COLLECTION 19 DATA DOWNLOAD 19 LED DISPLAY FUNCTION DESCRIPTION 20 COMMON PROBLEMS ANALYSIS AND TROUBLESHOOTING 21 AIRFLOW SIGNAL NASAL CANNULA 21 SNORING SIGNAL SNORE MICROPHONE IN RECORDER BOX 21 CHEST AND ABDOMEN EF
22. FORT SIGNAL CHEST AND ABDOMEN EFFORT SENSORS 22 SPO2 AND PULSE SIGNAL OXIMETER PROBE 22 CONNECTION PROBLEM USB CABLE 24 DOWNLOAD DATA USB CABLE 24 CURATIVE APPENDIX A TERM DEFINITION ERROR BOOKMARK NOT DEFINED APPENDIX B ELECTROMAGNETIC COMPATIBILITY INFORMATION 26 CURATIVE SYMBOLS CC A wd 0123 CE Marked indicating conformance to EC Directive No 93 42 EEC concerning medical devices Attention Consult accompanying documents Manufacturer Date of manufacture Serial Type BF Class Il number applied part Double insulated printed under the back cover The device DC Power accessories and the packaging have to be disposed correctly at the end of the usage Please follow Local Laws or Regulations for disposal CURATIVE SYSTEM INTRODUCTION USAGE e 1 15 designed to be used with a 32 bit Microsoft operating systems including Windows 2000 SP3 Windows 5 1 and above It is not compatible with 64 bit operating systems e The software has case management capabilities and can be used to store and analyze the information of more than one patient e The Acumen 7 can collect store and analyze 8 parameters of Polysomnographic data including Chest effort Abdomen effort Nasal airflow Snore SpO2 body position pulse rate and CPAP pressure When used with a Curative CPAP device SCOPE OF APPLICATION e The device can be used in the home or in medical
23. ING FILES Step 1 Reports Option Move Window teh Step 2 If New Record Select Scan m ones Chio file already File f Import Raw d BLUES S rom E scanne Sean List Download Data Ctrl D L File tab rare Crip pats you will be Close asked L W h et h e r 22 This file has already been scanned Rescanning the sil undo all changes made to the sleep stages and arfos events Do you want bo continue Print Print Preview you want to T Main process Print Setup 0 scan the file 1 DBackupiMy Documents User Manuals Versioni 12345112345 Liz385 12112 CAW 2 D BackuplMy Dacuments User Manuals New Versianiz010080600021201008060002 CAW a ga 3 D BackupiMy Documents User Manuals New Version saalaaa 4 BackuplMy Documents User Manuals New Ver son 20 100806000120 10358060001 CAW 5 DBackuplMy Documents User Manuals New Versioni 12345112345 CAW Se ct Ye S Ext or 65 Q GURATIVE Acumen 7 Step 3 T Scan files Scanning Scan List the file Sleep Stage Analysis Microarousal Analysis Desaturation Analysis Respiratory Event Analysis Leg Movement Analysis ACCE Analysis 66 CURATIVE FILE MANAGEMENT Step 1 Select T Sleep 1 9 0 0 USB Eile 3 New Record Ctr Open Record CHO management Import Raw Data from File tab pe
24. according to body positions Rapid Eye Movement and Non Rapid Eye Movement Respiratory distress index RDI table will list apnea and hypopnea indexes according to body positions and event types The overall respiratory distress index displays under the table DATA BACKUP DELETION e Managing the database is a necessary task After some time of database operation there tends to be some generated fragment which will cause the database become large and slow systemizing the database will remove all irrelevant data and make it simple and smooth 99 CURATIVE PSG Acumen User manual No OO version Curative Medical Technology Inc 100
25. and the hospital Hospital information De Qptiongiwindow Fields marked with must be completed The basic information of the information hospital is required for the report form Hospital Information iE Sync Time PF Sync Time can be found Option tab so that it can Mame of hospital Address shown on the cover of Telephone Other the report Save OK Cancel pre Step 3 To sync Sync time the time of the SN 20100714001 Device Version 1 004 device withthe Attention please connect the device to PC with USB computer clock 1010 22 cable synchronize the device time before you use Mar this device Make sure that the PC time is correct click Sync Time Save Farameter Data To save parameter data click Save Parameter Data 70 Q CURATIVE DATA PLAYBACK SCAN FILE FUNCTION The scan file function processes the raw sleep data and uses it to create waveform graphs that enable the user to easily analyze the Polysomnographic data It takes 2 to 5 minutes to scan an 8 hour file depending on the computer SCANNING FILES Step 1 Select pee E vemm Step 2 Now 7 Open File Open EN you have File list DataBase list Import Raw Data Ctrl I Rem PatientID Name Date of Birth Date of Re Filename access to the 201008060 111900 8 6 2000 D3BackupiMy Documents
26. as reorienting or relocating the Acumen 7 Polysomnograph B Over the frequency range 150 kHz to 80 MHz field strengths should be less than 1 V m stitched 29 GURATIVE Recommended separation distances between portable and mobile RF communications equipment and the EQUIPMENT or SYSTEM for EQUIPMENT or SYSTEM that are not LIFE SUPPORTING The Acumen 7 Polysomnograph is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the Acumen 7 Polysomnograph can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Acumen 7 Polysomnograph as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter Rated maximum output power of transmitter W 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz 30 CURATIVE 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 rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all s
27. eep Need to check base level setting The vertical axis shows the level of oxygen saturation in the blood The horizontal axis displays the length of time the patient has been asleep When the oxygen saturation level is below 9596 it is displayed in green Desaturation Hi Lo Plot This plot displays the High and Low points of the oxygen saturation level in the blood during sleep The vertical access shows the level of oxgen saturation in the blood The horizontal axis displays the length of time the patient 100 50 en 70 ED 50 T Oxygen Saturation Plot 22 08 Hors Desaturation Hi Lo Plot 22 08 23 08 00 00 08 01 08 v t gno qr tup wh 84 03 08 frg m I 0408 inar p 18 08 02 24 i apn Bee ta CURATIVE has been alseep Need explanation Desaturation Event Duration Plot This plot displays the duration of the oxygen desaturation events during sleep The vertical axis shows the length of the event in seconds and the horizantal axis displays the length of time the patient has been asleep in hours Snoring Waveform Plot This plot displays the frequency and decibel level of snoring events during sleep The vertical axis shows the decibal level of the snoring event and the horizantal axis displays the length of time the patient has been asleep in hours Desaturation Event Duration Plot 120 2208 23
28. equires completion Patient Information Department Information Medical History Contact Information Picture Fields which can be edited are displayed in white Fields that cannot be edited are displayed in grey 88 Patient information Medical History Picture Contact Information Department information First name john Last name white We Patient ID Date of Birth E i xb z 655888444 00 1900 01 01 vi 01 01 Female Weig m Heig Handedness po 0 cm Left 0 00 v Ib s 0 00 Gin C Right m OK Cancel Q CURATIVE REPORTS Reports can be generated using the Acumen 7 software to provide detailed analysis of a patients sleep data The reports that the Acumen 7 produces are e Respiratory Event Summary Report SpO2 Scored Summary Report 89 Q CURATIVE VIEWING REPORTS LOADING REPORTS Reports can be generated as a Microsoft Word documents Step 1 Select Reports Option Move Window Help Res piratory Current Reports event Repay Ever Summary 2 5 02 Scored Summary Renit K Report or SpO2 Scored Summary Repo rt Current Reports i from the 1 Respiratory Event Summary Report Reports tab 2 5802 Scored Summary Report Step 2 The reports will automatically open into a Microsoft Word document 90
29. ering with a blanket Position the sensor at a different site e g earlobe Allow the hand to rest comfortably without squeezing or pressing the sensor on a hard surface 22 CURATIVE detection Unable to obtain a green pulse displayed on the bar graph Frequent or steady pulse quality indication A dash appears in the The finger is cold The sensor is applied incorrectly There is possible interference from one of the following sources e arterial catheter e blood pressure cuff e electrosurgical procedure e infusion line The red LED is not illuminated in the finger insertion area There is excessive ambient light The Acumen7 is applied to a polished or artificial fingernail The red LED is not illuminated in the finger insertion area Patient motion is excessive A poor signal from the finger is Warm the patient s finger by rubbing or covering with a blanket Position the sensor at a different site e g earlobe Apply the sensor correctly Reduce or eliminate any interference Make sure that the sensor is not placed on the same position being used for other patient therapies or diagnostics e g blood pressure cuff Ensure that the sensor is securely attached to the Acumen7 Check the sensor for any visible signs of deterioration Contact Customer Support Shield the sensor from the light source Apply the sensor to a finger with no artificial or polished nails
30. ftware le Unidentified Device Searching Windows Update CURATIVE Step 3 If windows can not find the driver software for your device it will ask you to locate and install driver software manually Please select the second item Browse my computer for driver software advanced Found gt Unkemcwn Deoce Windows couldn t find driver software for your device Check for a solution Wide wall check to tec df there you can take fo get your decr Browse my computer for driver software advanced Leste aod stad drevet software Step 4 Click Browse button to locate the driver software on your computer find the Acumen7 software and click next 40 9 Exam 3 Found New Hardware Unknown Device Browse for driver software on your computer Search for driver software in this location C Acumen7USBDriver Browse s Include subfolders net Cancel 0 CURATIVE Acumen 7 Step 5 2 Windows Security Ex Step 6 Windows can t verify the publisher of this driver software Windows re WS y the publisher of this driver software windows will Installing driver software security will ask begin to Don t install this driver software You should check your manufacturer s website for updated driver software for ycur device you to install install the
31. gital converter A D 10Bit go Memory 64Mb Communication Ports USB RS232 AA 1 5VX2 DC 3V Power supply Classifications per IEC 60601 1 Battery Size Continuous Operating Time Battery Level Indication what does this mean Type of Protection 30 Hours Internally powered battery powered 40 CURATIVE Degree of Protection Type BF Applied Part Enclosure Degree of Ingress Protection IPXO Mode of Operation Continuous Operation Temperature 5 40 Relative humidity 1096 9096 non condensing Atmosphere pressure 700hPa 1060hPa Transport or storage Temperature 20 C 55 C Relative humidity 10 93 non condensing Atmosphere pressure 500hPa 1060hPa SAFETY INSTRUCTIONS AND CLAIMS HOW TO USE SAFELY e Before using the device read the safety instructions carefully to avoid possible dangers e The device must be used by you exclusively under the instructions of your physician e The device should only be used with CE marked parts provided or recommended by your authorized dealer e When your device doesn t work properly contact your dealer immediately e For electric safety read the following carefully Do not switch on the device if casing or cables are damaged In case of its failure contact your authorized dealer Do not open the device yourself Keep the device dry at all times Do not use the device in a damp room or a bathroom Do not place containers or glasses filled w
32. gital interfaces must comply with the respective IEC standards e g IEC 950 for data processing equipment and IEC 60601 1 for medical equipment All configurations shall comply with the current standard version for SYSTEMS IEC 601 1 1 If you have any doubt consult the technical service department or your local representative e Attention The sensor interfaces should be connected with correctly matched sensors e Attention The MIC Sensor interface should not be filled with anything PRODUCT AND ACCESSORIES Carefully unpack the Acumen7 and the accessories checking each item ageist the product component list If there are any defects or missing accessories please contact the suppliers or the manufacturer Recorder Box Chest and Abdomen Effort Sensor Belt USB Cable RS232 Cable CURATIVE SPECIFICATION OF DEVICE Body position whilst sleeping Oximeter The supine position The left recumbent position The right recumbent position Prone 70 to 100 Oxygen Saturation Range 96SpO2 Device Dimensions Material Weight Data and Data Communication Pulse Rate Range Accuracy SpO2 Saturation 96SpO2 20 to 255 pulses per minute 70 100 2 Accuracy Pulse Rate 3bpm Device Dimensions Height 4 94 125mm Width 2 75 70mm Height 0 94 24mm Recyclable ABS thermoplastic 150g without battery and sensors Data and Data Communication Analogue to Di
33. h to review in the open record function or select a recently opened file from the File tab If the file hasn t been scanned there will be no reports or trend plots To scan files refer to the previous section This is the view of a scanned file gt Sleep 1 9 0 0 USB File Wiew Reports Option Move Window Help xy patient 1 It displays the following channels e Chest Respiratory Effort e Abdomen Respiratory Effort e Air Flow und e Snore e Body Position e Battery Voltage SpO2 e Pulse Rate BodyPos SHORE Powery 100 70 120 40 R mg 22 00 00 RETO ae 14 CURATIVE EDITING EVENTS After the software has identified the sleep events the user is then able to access the properties of each event to mark the status of that event The event can be marked in 5 different ways 1 De No Validation so far No status Accepted Event is confirmed Doubtful Event is unconfirmed Manual Event can be edited manually Rejected Event is deleted ixi Event Fr p er fe b n Event Type Start Time 09 59 07 109 Duration z fie 2 Second Validation C Wo Validation so far C Accepted C Doubtful Manual C Rejected CURATIVE EDITING FLOW EVENTS A textbox will automatically pop up to display detailed information of these events MARKING AN EVENT When review
34. ife support e The device is not suitable for sporting activities e The device must be used under the instructions of doctor e The device must be used with CE marked parts or our supplied parts The use of other parts or materials may impact upon the safety of the device e Arechargeable Lithium Button Battery is used for the clock inside the device Danger of explosion and fire may occur if battery is replaced incorrectly Replace only with the same type of RTC battery Model TS621FE 3 0 V 3 mAh e Oximeter readings of the Acumen7 may be affected by the use of an electrosurgical unit ESU e Use only pulse oximeter sensors that are provided with the Acumen7 as these are manufactured to meet the accuracy specifications for the system Using other manufacturers sensors can result in improper pulse oximeter performance e use damaged sensors CURATIVE PRODUCT COMPONENTS AND DESCRIPTION PRODUCT COMPONENTS e 1 Recorder box e 1 Chest effort Sensor with Belt One Abdomen effort Sensor with Belt One Oximeter Probe e 1 Recorder Pouch e 1 7 software CD e 1 Nasal Cannula e 1 USB RS232 cable Note items with can be supplied by the manufacturer or purchased from other vendors that are CE marked e Attention The data transmission interface is only used for transmitting data in hospital and connects to RS232 or the USB of a PC e Attention Equipment connected to the analog or di
35. ing the recorded data using the Acumen7 software you can log sleep events and mark these on the waveform graphs The channels that can be marked are e Airflow e Snore e Power SpO2 All events across all channels can be marked by clicking on the beginning of the event on the waveform graph and dragging the mouse to the point where the event ends The details of each event can also be access by aa TEE single clicking the left mouse button Epoch 1 Length 8 8s The event shown here is an Obstructive Apnea BodyPos Left OSA event however all events marked across all channels will display the event information in this format when you single click the left mouse button 16 CURATIVE on the event AIRFLOW EVENTS Airflow events can be marked as Obstructive Apnea OSA Color Key Obstructive Apnea Central 5 Mixed Apnea MSA Obstructive Apnea Central Apnea Mixed Apnea Central Apnea Obstructive Hypopnea OH Obstructive Hypopnea Central Hypopnea CH Central Hypopnea Mixed Apnea Dn Delete Event Obstructive Hypopnea Properties Central Hypopnea Each type of airflow event uses a different color as shown in the color key 77 CURATIVE This is an example of the Airflow an IT Free waveform graph been marked with T MV S NE different events ll Obstrutveapneaos Central 5 SHORE
36. install 3 lt gt Storage controller 4 System devices Scan for hardware changes cj 8 Universal Serial Bu Properties Intel R 82801G_ 2708 Intel R 828016 ICH Family USB Universal Host Controller 27C9 9 Intel R 82801G ICH7 Family USB Universal Host Controller 27CA Intel R 82801G ICH7 Family USB Universal Host Controller 27CB Intel R 82801G ICH7 Family USB2 Enhanced Host Controller 27CC USB Root Hub USB Root Hub USB Root Hub USB Root Hub 44 Acumen 7 CURATIVE Step 4 Please select the second item Browse my computer for driver software advanced Step 6 Windows will start to install the software How do you want to search for driver software Search automatically for updated driver software Windows will search your computer and the Internet for the latest driver software for your device Browse my computer for driver software Locate and install driver software manually Installing driver software Step 5 Click Browse to locate the driver software on your computer Step 7 Windows security will ask if you want to install the driver software Select Install this driver 45 Acumen 7 Browse for driver software on your computer Search for driver software in this location C Acumen7USBDrived v Include subfolders gt Let me pick from a list of device drivers on my computer This list will show installed
37. isorder Analyses Apnea Hypopnea Event Analysis Analysis pm EE NE Analvsis Event Lists Saturation Analysis pi snoring Analysis y ps Log Event List ES CHTM Log Event List adis from View ETNE shown b Patient Information Patient Information a m 93 CURATIVE RESPIRATION EVENT ANALYSIS Respiration Event Analysis displays apnea length and apnea body position and also hypopnea length and body position This analysis helps to see if there is a correlation between the body position when asleep and the occurrence of apnea or hypopnea Respiration Event Analyse BE Apnea Leneath Apnea BodyPoz Hypopres Length OXYGEN SATURATION ANALYSIS Oxygen Saturation Analysis displays the frequency as a percentage the SpO2 levels over time and the Desaturation levels of oxygen as a percentage in the blood Spo Analyse ar A 94 CURATIVE SNORING ANALYSIS The Snoring Analysis plot displays the sound level dB of the snoring and the percentage of snoring that was at that sound level Snoring analysis also displays the percentage of snoring that was experienced in different sleeping positions 7 Snoring Plot Snore dB 20 22 24 5 28 30 32 34 36 38 40 42 44 46 48 50 52 54 56 58 62 64 EVENT LISTS There are two types of event list e Respiration Event List e Desaturation Event List 95 CURATIVE RESPIRATORY EVENTS The Res
38. ith liquid on the device or place the device near water e g bathtubs X X 9 14 CURATIVE o Take the batteries out of the device before cleaning LIABILTY The manufacturer shall not be held liable for any damages in case of e Tampering modifying adding expansion features or repair by persons who have not been authorized by the manufacturer e Using accessory or spare parts that are not recommended by us or not officially registered e Using the device in way that was not instructed in the manual CLEANING AND MAINTENANCE CLEANING THE ACUMEN7 e Clean the enclosure of the Acumen7 recording box with a soft cloth dampened with isopropyl alcohol Do not pour or spray any liquids onto the Acumen7 and do not allow any liquid to enter any openings of the device Allow the unit to dry thoroughly before reusing it e IMPORTANT Do not immerse the Acumen7 in liquid and do not use corrosive or abrasive cleaning agents on the Acumen7 e Clean the Acumen7 and the sensors separately e For instructions regarding the cleaning of the Pulse Oximeter sensor and the Nasal Cannula refer to the appropriate product guides MAINTENANCE e The advanced digital circuitry within the pulse oximeter of the Acumen7 requires no calibration or periodic maintenance e Field repair of the Acumen7 circuitry is not possible Do not attempt to open the Acumen 7 recorder box or repair the electronics Opening the case will damage the Acumen7 and void
39. ituations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 31 0 CURATIVE ACUMEN SOFIWARE CURATIVE COMPUTER SPECIFICATIONS Processor Memory Cache memory Hard disk Power supply Operation system Minimal configurations Pentium 4 1 6 GHz 256M 128K 5G 220x 1 10 Va c 50x 1 2 Hz 32 bit Windows 2000 Windows XP 33 Recommended configurations Pentium 4 2 0 GHz 512M 512K 80G 220x 1 10 Va c 50x 1 2 Hz Q CURATIVE SOFTWARE INSTALLATION PROCEDURE e Insert Acumen7 disk to your disk drive e The installation programs will automatically startup within 60 seconds If it doesn t startup the executable program Setup exe inside the installation catalogue on the disk can be operated to start installation Install the software as per the indication on the screen The software does not startup automatically Step 1 Double click the Setup exe file to run the installation program InstallShield Vizard Preparing to Install Acumen Setup it preparing the Wicard drach sc A setup process Checking Operating Syttem Veron Step 2 Click next to continue the installation 34 Acumen InstallShield Wizard Welcome to the Installshield Wizard for Acumen The iret Wizard vell instal Acumen on your computer To continue cick Next WARNING This program co
40. l be taken to the PHIM main screen of the Acumen 7 software The main screen is used to display data that has SHORE been downloaded from the Acumen 7 device or BadyFos imported from a file Poser 100 40 CURATIVE OPENING A RECORD Step 1 Select Step 2 Open File pen Window File list DataBase list Open Mew Record Select EE PatientD Date ofBirth Date of Re Filename Reco rd fro m Open Record t h e 11900 Bu zt m ET Hei Documentsillser Manuals Import Raw Data from File Location Ctrl 1 201008060 14900 7115 2010 D aBackupWy DocumentsiUser Manuals File tab DOR DRE CN temm record 1 4900 8 5 2010 DiBackupiMy DocumentslUser Manuals Erase Chip Data you Wa nt Close to open Scan File File ANagene nt ons Ctri P Ei Print Preview Print Setup 1 D 1BackupiMy Documents Acumen 7 Demo Datal5554446661555444666 CAW Directory DABackupiMy DocumentsiUser Manuals New Version Eu gi Ext 55 Q CURATIVE Step 3 Click OK to open Open File File list DataBase list record File name 201008060 11 1900 8 5 2010 Documents ser Manual 201008060 141900 7415 2010 DiBackupiMy Documents ser Manual aaa 1 1 1900 8 5 2010 D BackupiMy DocumentsWser Manual Directory DABackupiMy DocumentsiUser Manuals New Version Bi
41. lease connect to PC again with USB cable and click Refresh button to get records list 25 Q CURATIVE APPENDIX B ELECTROMAGNETIC COMPATIBILITY INFORMATION Guidance and manufacture s declaration electromagnetic emissions for all EQUIPMENT and SYSTEMS The Acumen 7 Polysomnograph is intended for use in the electromagnetic environment specified below The customer of the user of the Acumen 7 Polysomnograph should assure that it is used in such an environment Emission test Compliance Electromagnetic environment guidance RF emissions The Acumen 7 Polysomnograph uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic CISPR 11 equipment RF emission The Acumen 7 Polysomnographic is suitable for use in all establishments including domestic Class B establishments and those directly connected to the public low voltage power supply network CISPR 11 which supplies buildings for domestic purpose Harmonic emissions Not applicable IEC 61000 3 2 Voltage fluctuations flicker emissions Not applicable IEC 61000 3 3 26 GURATIVE Guidance and manufacture s declaration electromagnetic immunity for all EQUIPMENT and SYSTEMS The Acumen 7 Polysomnographic is intended for use in the electromagnetic environment specified below The customer or the user of Acumen 7 Polysomnographic should assure that it
42. ly affected by Electromagnetic fields exceeding the level of 1V m in the test conditions of EN 60601 1 2 The operation of high frequency diathermy equipment Defibrillators or short wave therapy equipment Radiation e g x ray CT Magnetic fields e g MRI Avoid using this device in an MRI environment or proximity to a high EMI emission source od Xy x e submerge the device in water e Do not place liquids on or near the device e use the device if you are wearing a nasal or full face mask for CPAP or bi level therapy This will affect the accuracy of the device e use the device if you are wearing a cannula for therapy This will affect the accuracy of the device e If any unexplained change in the performance of this device occurs if the device is dropped or mishandled if water is spilled into the enclosure or if the enclosure is broken discontinue use and contact our service center e If any part of the device is broken please stop using the device e Use only our supplied sensors and accessories Use of other accessories could cause the device to malfunction e The device must be repaired or checked by qualified personnel Do not open the device and change any part yourself e This equipment complies with International Standard EN 60601 1 2 2007 for electromagnetic compatibility for medical electrical equipment and or systems This standard is designed to provide reasonable protection agai
43. nd recycling instructions regarding the disposal or recycling of the device and its components including batteries Use only Size AA 1 5VX2 batteries If the Acumen7 is not used for 30 days remove batteries e Afunctional teater cannot be used to assess the accuracy of a pulse oximeter probe or a pulse oximeter monitor WARNINGS e This equipment can t be used as a monitor of apnea because it has no audible or visual apnea warning system e Skin irritation may occur as a result of the cannula or belt used by the patient e Discontinue using the device it if skin reddening or inflammation appears e The evaluation of the PSG Acumen7 electrical isolation must be conducted by a certified engineering or biomedical personnel who are qualified to make such an assessment e Patients with parasomnias or seizures may be at risk of injury that may occur due to movements during sleep CURATIVE e Institution specific policies and guidelines describing personnel responsibilities and appropriate responses should be developed e Do smoke while wearing the Nasal Cannula e Avoid exposure to sources of direct airflow such as fans during the operation of the device e allow the cables to become tangled coiled crossed or wrapped around the neck arms or legs This could result in strangulation e Donot operate the device in the presence of flammable substances such as anesthetics or cleaning agents e The device is not to be used for l
44. nst harmful interference in a typical medical installation However because of the proliferation of radio frequency transmitting equipment and other sources of electrical noise in healthcare and other 8 CURATIVE environments it is possible that high levels of such interference due to close proximity or strength of a source might disrupt the performance of this device e Cardiogreen and other intravascular dyes may affect the accuracy of SpO2 measurements e The oximeter sensor might not work in cold extremities due to reduced circulation Warm or rub the finger to increase circulation or reposition the sensor e Somenail polish colors or artificial nails can reduce light transmission and affect SpO2 accuracy e Before using any sensor read the User Directions carefully They contain the specific application duration for each sensor e Check the pulse oximeter sensor application site frequently to determine the positioning of the sensor the circulation and skin sensitivity of the patient A patient s sensitivity to sensors may vary due to medical status or skin condition e Acumen7should not be gas sterilized or autoclaved e The Acumen 7 uses size AA 1 5VX2 batteries The batteries should only be replaced by professionals instrument operators rather than the patient Replace the cover after changing the batteries e Batteries should be used and disposed of appropriately to avoid leaks or explosions e Follow local government guidance a
45. ogram select it from the list and then click Uninstall Change or Repair Organize Name CCleaner Ei Evernote v 4 Scrivener for Windows Beta Windows 7 USB DVD Download Tool ii VMware Workstation i calibre Acumen j9 Acumen USBDriver Acumen 7 adobe Photo Uploader for Facebook Adobe Flash Player 10 ActiveX SopCast 3 29 Adobe AIR Feedback Tool Publisher Piriform Evernote Corp Creative HQ Microsoft Corporation VMware Inc Kovid Goyal Curative Medical Curative Medical Curative Medical Technology Inc Adobe Systems Incorporated Adobe Systems Incorporated www sopcast com Adobe Systems Inc Installed On 29 10 2010 27 10 2010 27 10 2010 26 10 2010 26 10 2010 25 10 2010 15 10 2010 06 10 2010 30 09 2010 28 09 2010 27 09 2010 25 09 2010 19 09 2010 Version 3 00 4 0 0 2880 1 10 240 71 214247 0 7 24 5 0 152 1311 4 0 50917 0 1 0 0 10 1 85 3 329 2 0 3 13070 110 Microsoft Corporation 16 09 2010 MU Tarrant 43 MO PA T Currently installed programs 69 program installed Total size 10 2 GB 48 Q CURATIVE INTRODUCTION TO THE ACUMEN 7 SOFTWARE The Acumen 7 software is used to e Download data from the device e Analyse and display data across the 7 channels e Create plots to compare and diagnose sleep conditions e Produce Respiratory Event Summary and SpO2 Scored Summary Reports e Add any other functionalities
46. on Next to Name input the First Name Last Name next item of Patient ID Date of Birth Sex Male information 10001112 1 11 1950 C Female Weight Height Handedness Important 49 C Left Right A Patient ID Comments must be entered Step 4 Input Contact Information Select Next 52 New Record Contact Information Contact Information Tel Post de Mobile E mail Address Other Prior Next gt Cancel Q CURATIVE Step 5 Input correct data of department information Select Next 7 New Record Department Information Record Date 9 11 2010 Length Start 10 00 00 PM Stop Personnel Operator x Sleep Tech Department x physician Hospital File Documerr Prior Next Cancel 2 3 Step 6 Input correct data of medical history Click Finish button to collect Real time data 2772777 53 7 New Record Medical History Medical History Patient did Seizure Type Sleep Disorder Medication bs Medication Prior Finish Cancel Q CURATIVE Sleep 1 9 0 0 USB 10001112 Step 6 When the Soe te ror tae ws m 0 7 0 1015 30 60 mm kK amp 1 gt gt 5002 0 HRate BodvPos patient inofrmation has been completed you wil
47. orrelated SpO2 value occurring within 30 seconds after the respiratory events 97 GURATIVE Min SpO2 in PSG report displays min SpO2 and the duration of correlated respiratory events Min SpO2 Min SpO2 reading occurs during oxygen desaturation stage The average of electrocardiograms within 30 seconds ACUMEN 7 calculates the dynamic average of heart rates within the last 30 seconds The average heart rate is the reciprocal of the average of QRS wave within the last 30 seconds The average heart rate is the reciprocal of the average of wave within the QRS clip period of excessive noise is not calculated The maximum and minimum values of electrocardiogram the maximum and minimum heart rates calculated based on the average within 30 seconds in each QRS wave time The period of excessive noise is not included in calculation and the heart beat intervals in which the difference compared with the current average is more than 50 are also not included in calculation Tachycardia the average heart rate with continuous two or more than two QRS waves within 30 seconds exceed 100 beats minutes Bradycardia the average heart rate with continuous two or more than two QRS waves within 30 seconds is lower than 60 beats minutes SUMMARY REPORT The maximum and minimum heart rates these values are based on the maximal and minimum values within the whole recording clip Individual calculation is used for sleep clip and awaking clip Average heart
48. ot Multi Trend Plot 2 Single Plots between of Single Apnea Hyponea Event Desaturation Event Multi Trend Plots Duration Plot Duration Plot Plot or available Apnea Hyponea Event Type Snoring Waveform Plot tt Multi Trend Plot Plot 2 82 Oxygen Saturation Plot Desaturation Hi Lo Plot Body Position Plot CPAP Pressure Plot CURATIVE UNDERSTANDING THE DIFFERENT PLOTS AND WHAT THEY MEAN Apnea Hyponea Event Duration Plot This plot displays the frequency and length of apnea and hyponea events during sleep The vertical axis shows the length of the apnea or hyponea event in seconds and the horizantal axis displays the length of time the patient has been asleep in hours The different colours of the bars denote the type of apnea or hyponea event Apnea Hyponea Event Type Plot This plot displays the distribution of apnea or hyponea events during sleep The vertical axis shows the different types of apnea or hyponea and the horizontal axis disays the length of time the patient has been asleep Apnea Hypopnea Event Duration Plot 22 08 23068 Apnea Hypopnea Event Type Plot 22 08 23 08 08 01 08 02 08 PE MEE LT TM MAE T MEE M EL MEET 160 EE MI LLL ELEME Hours 1 2 3 5 83 05 08 OLE 0 34 EER CURATIVE Oxygen Saturation Plot This plot displays the oxygen saturation level in the blood during sl
49. p exe file with the mouse to run the installation program 37 CURATIVE Step 3 Click next to continue the installation Step 5 Click Finish to complete the installation Step 4 Wait for Setup has enough to start copying the program files you want to review or files to om liters Click Back sou aso vh iha Click Next to began COPY Acumen USBDriver Installshield Wizard li InstallShield Wizard Complete Setup has netaling Acumen USBDrver on your Compuler Bock Cancel 38 Acumen n corhgunng your neve oltre Q CURATIVE INSTALL USB DRIVER MANUALLY Step 1 Connect the device to the PC using the USB or RS262 cable When the computer finds the hardware the Found New Hardware window will pop up Select the first item Locate and install driver software recommended 2 Windows needs to install driver software for your Unknown Device Locate and install driver software recommended Windows mil guide you through the process of initalhng driver software for your Ask me again later Windows wall atk agen the next tme you plug in your device or log on Don t show this message again for this device Your device will not luncbon untd you install diver software Step 2 Windows will search driver software automatically 39 Installing device driver so
50. piration Event List displays each respiration event that has been marked and shows the data that is relevant to that event um Breathing Event List Ani xj It displays the page of all respiratory events start time 21 24 20 E Sta 5 p ae EE GEA Sons Supne di i a duration type sleep stage body position the max and min 48 21 25 15 10 9 HSA Stage 1 Supine 35 92 88 81 49 21 25 28 120 Stage 1 Supin 35 89 92 37 50 21 25 58 252 OSA Sanne 26 91 90 82 5 02 the max and min heart rate 51 21 26 34 235 OSA Stage 1 supine 96 96 93 30 52 21 27 12 242 Stage 1 Supine 99 92 91 80 53 21 27 49 264 OSA Stage 1 Supine 85 93 81 OXYGEN DESATURATION EVENTS The Desaturation Event List displays each respiration event that has been marked and shows the data that is relevant to that event SSdesaturation List ___ List It displays the page of all desaturation Supine i 1 7 21 24 28 270 Oxygen Stage 1 Supine 95 88 85 83 events start time duration type sleep 48 21 24 57 220 Oxygen Stage 1 Supine 94 89 85 81 m 48 212621 450 Oxygen Supine 45 86 97 82 stage body position the max and min SpO2 50 21 26 08 430 Stage 1 Supine 96 85 a9 80 52 21 26 53 31 0 Owgen Stage 1 Supine 98 103 80 1 53 21 27 26 37 0 Oxygen Stage 1 Supine 94 85 100 81 and the max and min heart rate 54 21 28 05 380 Oxygen Stage 1 Supine 96 83 103 23 E 96 Q
51. pyright law and international treaties CURATIVE Step 3 T Acusen Inata all amp hie ld Vizard select the Destination Folder Chck Nest to install to this folder or did Change to install to a folder installation Brest all Acumen to pathway am Acumen and click next Step 4 After rs Acunen inztall hield Vizard having setting si ae hela The waard ready to begn installation up the pathway click Install to continue installation of software 35 CURATIVE Step 5 wait rs Acusen Inzgtallshield Vizard for Installing Acumen The program you selected are being net sed installation to complete Sats Step 6 Click Finish to complete installation Now there will be a shortcut on the program menu column of the system anda shortcut icon on the desktop 36 if Acumen k IngtallShield Vizard Iris t alShiekd Wizard Completed Check Finish to exit the wizard Q CURATIVE INSTALL USB DRIVER AUTOMATICALLY Step 1 Insert Step 2 to metal Click Welcome to the InstallShield Wizard lor Acumen USBDrirver Acumen _USBOriver Setup 6 preparing the Installshield next to nom continue MATH Acumen7 disk to your disk peike bial the driver Copy the file Acumen7 _USBDriver EN rar to your PC n and extract it Double click the Setu
52. re displayed in yellow as standard To delete an event single click on T r i _ the right mouse button and select 3 Delete Event TO EE ess Delete Event Properties BodyPos 4 lt 4 4r lt P 120 40 81 Q CURATIVE VIEWING AND UNDERSTANDING TREND PLOTS VIEWING TREND PLOTS There are two different types of trend plots that can be viewed using the Acumen 7 software There are Multi trend plots and single trend plots VIEWING MULTI TREND PLOTS AND SINGLE PLOTS Step 1 To T Sleep 1 9 0 0 USB Step 2 To Sleep 1 9 0 0 USB File R ts Option M Window Hel view File Reports Option Move Window Help view Single 0 acre IINdow MuliTrend Plots MultiTrend 8 MultiTrend Plots Multi Trend Plot Plots TE Single Plots Apnea Hypopnea Event Duration Plot Plots mt Single Plots gt Multi Trend Plot 2 Sleep Disorder Analyses Apnea Hypopnea Event Type Plat Sleep Disorder Analyses F Select Event Lists Oxygen Saturation Plot i Desaturation Hi Lo Plot Select Event Lists gt Single eat Fi T i Patient Information Desaturation Event Duration Plot MultiTrend Log Event List Plots from Snoring Waveform Plot P Plots from patient Information View tab Body Position Plot EN Pressure Plot View tab i Choose from the list Multi Trend Pl
53. scc Ele Option Window Help Records Information Ke POE ane New Open Record Cirl 0 then select Save to Directo R d Import Raw Data from File Location Cir h DABackuplMy Do cumentst EPO Download Data from Device Ctrl D Jer from File Erase Chip Data would like to PN Disk Information tab Close store your 656 1 Scan File T NNI data Print Ctrl P amp s r Local Disk C Tek Paint Preview Attention ee H nt Setur Ew Local Disk F Prin a Ensure that Shared Documents m 1 D Backup My Documents Acumen 7 Demo Datal5554446661555444666 CAW Administrator s Documents k th ii amp My Network Places 1 D Backup My DacumentslAcumen 7 Demo Datal5554446661555444666 CAW you Know the El O9 ferm 1 SR ker location of the file You can also see the available disk space in this window and the amount of recording time available 51 CURATIVE Note the remaining time displayed on the above plot is based on the current hard disk partition If the remaining hard disk space is less than 500M it should be noted to collect spatial processing What does this mean Appropriate measures should be adopted for example changing the storage pathway backing up files and deleting useless files to clean the adequate hard disk space for usage in the next data acquisition Step 3 New Record Select Patient Informati
54. side the nostrils and re check the display Make sure the cannula is firmly attached to the main device by turning the connector in a clockwise direction Replace cannula Contact medical provider for replacement Ensure the clear slide is against the chin to secure the cannula Use small pieces of tape to secure the cannula prongs to the cheekbones DO NOT PLACE TAPE OVER THE MOUTH OR NOSTRILS Possible Solution Contact 7 Customer Support 21 CURATIVE CHEST AND ABDOMEN EFFORT SIGNAL CHEST AND ABDOMEN EFFORT SENSORS Problem The chest and abdomen waveforms are too small or is a line Possible Cause The chest and abdomen belts are too tight The chest and abdomen belts are too loose The chest and abdomen effort sensors have broken SPO2 AND PULSE SIGNAL OXIMETER PROBE Problem Unable to obtain a green pulse display on the bar graph Note In some occasions patient perfusion may be inadequate for pulse Possible Cause The patient pulse strength is low Circulation is reduced because of excess pressure on the sensor between the sensor and a hard surface after inserting finger Possible Solution Adjust the chest and abdominal belts Adjust the chest and abdominal belts Contact Acumen7 Customer Support Possible Solution Reposition the finger or insert a different finger and keep the sensor motionless for at least 10 seconds Warm the patient s finger by rubbing or cov
55. the warranty If the Acumen7 is not functioning properly see Troubleshooting CURATIVE e Inthe case of any product issues contact our service center Service of the Acumen7 should only conducted by persons authorized by our company e Proper use and maintenance of the Acumen7 will extend the working life of the equipment see safety and cleaning instructions e Before maintenance ensure that the device is disconnected from any power source e The Acumen7 equipment should be managed by a specially assigned person e The 7 and its accessories should be kept in dry storage environment to prevent the device from damp and corrosion The device should also be kept away from sources of strong electromagnetic fields that may cause interference e The Acumen7 has been accurately assembled by the manufacturer Curative Medical Technology and users should not disassemble or adjust the system randomly e When abnormal conditions occur or this system cannot operate normally please contact our company or local maintenance department DISPOSAL This device its accessories and its packaging have to be disposed correctly at the end of the usage Please follow Local Laws or Regulations for disposal CURATIVE SYSTEM INSTALLATION AND USAGE SYSTEM CONNECTION Chest Abdom USB 95232 CURATIVE ACCESSORIES CHEST AND ABDOMEN OXIMETER PROBE NASAL CANNULAR EFFORT SENSORS The chest and abdomen effort
56. uency of the transmitter Recommended separation distance TEE 1 80 MHz to 800 MHz 800 MHz to 2 5 GHz Where P is the maximum output power rating of the 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 a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol 28 GURATIVE 1 At 80 MHz 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 A Field strengths 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 Acumen 7 Polysomnograph is used exceeds the applicable RF compliance level above the Acumen 7 Polysomnograph should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such
57. units for clinical monitoring analysis and diagnosis of relevant physiological signals including the thoracic and diaphragmatic respiration nasal airflow snoring SpO2 and sleeping positions e The device is used in clinical sleep laboratories to assist in the diagnosis of sleep disorders by gathering storing and analyzing data across 7 parameters of physiological events during sleep e This equipment can only be used under the directions of a qualified sleep clinician CONTRAINDICATIONS There are no absolute contraindications to polysomnograph when indications are clearly established However risk benefit ratios should be assessed if medically unstable inpatients are to be transferred from the clinical setting to a sleep laboratory for overnight polysomnography Explosion Hazard Do not use the Acumen7 in an explosive atmosphere or in the presence of flammable anesthetics or gases CURATIVE CAUTIONS e The PSG Acumen7 analyses overnight sleep information acquired from the raw data of the recorder Any loss of raw data due to interferences caused by loss of power incorrect use of the sensors and device strong electromagnetic fields or human factors can all result in incorrect raw data and consequently incorrect analysis e Itis important that the device is corrected calibrated as a device that is not correctly calibrated will not provide accurate data e No SpO2 or pulse rate alarm is provided e Operation of the device may be adverse
58. up Documents ser Manuals New Versionl2345112345 L11235511211 2 CAW 2 DilBackup My Documents User Manuals New Versionlz010080600021201 008060002 CAW b efo re p ri nti n g 3 DA Documents User Manuals New 4 D BackupiMy Documents User Manuals New Version 201 0080600011201008060001 CAW p nti n E Sele ct 5 Dri BackupiMy Documentsjuser Manuals New Version 234512345 Print gi et Preview 68 GURATIVE Step 3 View of document zoomed out NUNAN t 120k ee PTT CERE MD il de do oy dk Y ode TOI6 I6 Xo X EOM M M oix x 372202 2D Z0 DI XP XD 31330 10 T 20 I 20 24 10 10 X1 X1 TE i pp 1 Li H 1 Step 4 Use the Print Setup to change printer or adjust any print settings 69 Print Setup Printer Name 192 1 58 0 249 erox WorkCentre 31 19 Properties Status Ready Type xerox WorkCentre 3119 Where 158001 Comment Paper Orientation Size Ad Portrait Source Auto Selection Landscape Network OK Cancel CURATIVE HOSPITAL INFORMATION AND TIME SYNCHRONIZATION Step 1 Hospital T Sleep 1 9 0 0 USB Step 2 Enter Information
59. vice but encountered an error while attempting to cannot be software Curative Medical Acumen 7 successfully was not installed The syster cannot find the file specified successfully windows installed WI p rom pt TEREN of your device you can visit its website and check the support that Windows encountered a problem installing the driver software for your device 43 Q CURATIVE Step 3 Open Computer Management by right clicking ion my computer on your desktop Right click Other devices right click Unknown device item and select Update Device software menu This section is not explained well and I cannot follow the instruction easily and some options are not available DUTET if a a PENT IPS xad rac n mie dk Computer Management Loca 4 System Tools gt Task Scheduler b Event Viewer gt Shared Folders b Local Users and Groups gt Reliability and Perf Device Manager 53 Storage iaf Disk Management gt B Services and Applications IGIBES amp 6 dl Computer Display adapters 3 gl DVD CD ROM drives 95 Human Interface Devices cy IDE ATA ATAPI controllers lt gt Keyboards 3 fA Mice and other pointing devices Monitors Network adapters E fp Other devices m 3 COM amp LPT Update Driver Software 0 Processors Disable Sound videosnd Un

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