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User Guide - Frank`s Hospital Workshop

1. 82 7 1 TROUBLESHOOTING 82 8 ual Eae 83 8 1 BAPTBERY estet ud A 83 8 2 CHANGING THE BATTERY MODULES cccccccccccecccccccccceccucueccucccuucuuueuecueucuuuaueuaueecuueueuauenas 83 8 3 CHANGING THE THERMAL PAPER cccccecccccccccccccceccecuecccucueccueecuucueeuuuecuueuuuaueusuuecuueueuenenas 83 8 4 CLEANING amp DISINFECTION ccccccccccccccccccccccccucueveueucuuucuucuevcuuauuueueuaueucuueuuveueusuuceuueueusuenas 83 8 5 WEEKLY INSPECTION cccccccccccccceccecuccecccececcececeuectecenenuccecucuensceuecuusudeuesuususeuescesesteneunes 84 8 6 PE VICE REI RR NUR 85 8 7 ML EL M AM uc Miu LM AN a E La e 85 9 SPECIFICATIONS 2 86 9 1 SYMBOBDIRECTORY mentes munitis muni wed actu 86 9 2 ACOUSTIC OUTPUT FABEE ee tere ol e t e Pace oda Rte at toe e a bs 87 9 3 DEFINITIONS AND SYMBOLS 0 0 0 1 6 89 9 4 SPECIFICATION OF 0 0 94 10 ENVIRONMENTAL 65
2. 54 CUBEscan 5 5 8 Customizing Other Setup Options 1 Press SETUP option on the Top Screen 2 Move the position cursor using MUP option or DOWN MDOWN option to select the desired option 3 Press SELCT option The position cursor will move to the right of the selected item 4 Browse the options by using LEFT OUP option or ODOWN option Position Cursor In Setup Screen ERN Clinic Name MCUBETECH 5 Set Date Time 2007 10 10 15 00 Print Option gt Raw Image Flash Store On Setup Print Scan Result B Mode Auto Power 7 minutes Calibration Return Prescan Enable On Exit Context Menus ODOWN ENTER E Fig 19 Setup Item Option Screen 5 Select setup item option ENTER ENTER option Then the selection cursor moves to the left hand side of the Setup screen 55 CUBEscan 5 The following table lists the customizable setup options Setup Item Option Meaning Print only the Urine volume Raw Image Print the Urine volume and all 12 planar images and bladder contour Print Option Walls Print the Urine volume and the contours of the 12 All Planes Print the Urine volume and the images and bladder contours of all 12 planes To turn the flash store function To turn off the flash store function Contour Show bladder outlines without images in the Scan Boll Results Screen B Mode Show bladder outlines with images in the Scan
3. e Te ss OSAA 4220 m Other p at max 1 pow Information at max hi deq Pllmax cm LLL es OOG at max MI IpA 3 M Imax wen of Operating Frequency Control Conditions Notes a This index is not required for this operating mode see section 4 1 3 1 of NEMA Standard UD 3 87 CUBEscan 5 b This probe is not intended for transcranial or neonatal cephalic uses c This formulation for TIS is less than that for an alternate formulation in this mode No data are reported for this operating condition since the global maximum index value is not reported for the reason listed Acoustic Measurement Precision and Uncertainty All entries in the below table have been obtained at the same operating conditions that produce the maximum index value The measurement precision and uncertainty values are determined by repeated measurements Precision Uncertainty Parameter of standard deviation 95 m 88 CUBEscan 5 9 3 Definitions and symbols T1Sscan TIS non scan TIB TIC Aaprt Dr 3 Wo W 3 Z1 Ita 3 Z1 21 deq Z the Mechanical Index the Soft Tissue Thermal Index in an auto scanning mode the Soft Tissue Thermal Index in a non auto scanning mode the Bone Thermal Index the Cranial Thermal Index the area of the active ape
4. i I 41101001691 Plate guide 1 41101001701 Plate quide 2 Chart basket 4110100174 Leg module 4110100165 Leg 4110100166 Caster o T I gt o OOL 10mm Hexagon wrench it olt olt Bo o e s jm s prc Man Machined E Midi Technology Co Ltd 28 CUBEscan BioCon 500 BioCon 500 Rolling Cart Main body Holder EA Adapter Holder 1 Probe Holder Holder 1EA Part Number 4110100153 Part Number 4110100154 Part Number 4110100155 Part Number 4110100156 Basket Plate Module 1EA Chart basket 1EA Hub 1EA Leg Module 5EA Part Number 5110100168 Part Number 41404004744 Part Number 4110100161 Part Number 4110100165 4110100170 _ 4110100186 g Ha ho Ww Lower Column 1EA Upper Column 1EA Spring 1EA Lock Handle 1EA Part Number 4110100157 Part Number 4110100158 Part Number 4110100158 Part Number 4110100160 3mm Hexagon Wrench 1 bmm Hexagon Wrench TEA 7 4 mm Hexagon Wrench 1EA qum e Moo oure Mcubs Technelegy C Ltd 29 CUBEscan r BioCon 500 BioCon 500 Rolling C
5. 001 96 TOA 96 10 2 BATTERY LOE stet Ee es tana itenim sene aree 97 CIUES Tre 98 12 REFERENCES 2 bouis 99 VI CUBEscan 5 1 DEFINITIONS These definitions are used in this user guide WARNING CAUTION IMPORTANT Describes precautions necessary to prevent injury or loss of life Describes precautions necessary to protect the products Describes information that a user should know for safe and effective use of this system Tactile switch Context menu based on system state Screen CUBEscan 5 2 GENERAL INFORMATION 2 1 Indications for Use The BioCon 500 is a B mode pulsed echo ultrasound device The BioCon 500 is intended as a portable battery operated device 500 projects ultrasonic energy through the abdomen of the patient obtaining images of the bladder in order to calculate the urine volume non invasively The BioCon 500 is intended to be used only by qualified medical professionals Contraindications for the BioCon 500 are fetal use and use on pregnant patients 2 2 Contraindications Do not use the BioCon 500 on following cases a Fetal use or pregnant patients b Patients with ascites c Patients with open or damaged skin d Wounds in the suprapubic region 2 3 Prescrip
6. Results Screen To turn off auto power off Turn the system off if there is no input for 3 minutes Auto Power Turn the system off if there is no input for 5 minutes Turn the system off if there is no input for 7 minutes Turn the system off if there is no input for 10 minutes Turns on Pre Scan functionality Prescan Enable OFF Turns off Pre Scan functionality 56 CUBEscan 5 5 9 Calibrating the BioCon 500 Using the Calibration Kit 5 9 1 Preparing the calibration kit 1 Open the cap of the calibration kit and pour 0 9 saline solution up to the fill mark of the calibration kit 2 Close the cap 3 Align the probe scan button with the arrow mark on the calibration kit then insert the probe into the holder ensuring it is secure IMPORTANT Purge all air bubbles form the system You can also use distilled or DI water instead of the saline Purge the system of air bubbles in this case as well 5 9 2 Calibrating the BioCon 500 with the calibration kit 1 Connect the probe which is positioned into the probe holder of the calibration kit to the console 2 Turn on the console Screen Display in the BioCon 500 Date amp Time The Top Screen Battery Status 200810110 Press to go to setup menu PM 03 00 CubeScan Version X XX MCUBE TECHNOLOGY Setup Menu etup Value Setup Menu Go to Calibration setup using or P Clinic Name MCUBETECH Set Date Time 2007 10 10 15 00 DOWN
7. Print Option Raw Image Flash Store On Setup Print Scan Result Auto Power 7 minutes Calibration Prescan Enable On Exit Context Menus MDOWN SELCT E EXIT P 57 CUBEscan m 5 In Setup 9089 Setup Menu Setup Value Press key Clinic Name MCUBETECH Set Date Time 2007 10 10 15 00 Print Option Raw Image Flash Store On Setup Print Scan Result B Mode Hons Auto Power 7 minutes Options Calibration Return Prescan Enable On Exit Context Menus MDOWN MUP tT SELCT E EXIT P Setup Menu Position Cursor Select the Start setup value using LEFT or RIGHT In Setup Screen Clinic Name MCUBETECH Set Date Time 2007 10 10 15 00 Print Option Raw Image Flash Store On Setup Print Scan Result B Mode Fon Auto Power 7 minutes Options Calibration j Start Prescan Enable On Exit Context Menus MDOWN MUP f SELCT E EXIT P Calibration top screen Last Calibration Date RL To start calibration press ENTER Context Menus CSTART E Screen during calibration Last Calibration Date To stop the calibration process press Calibrating the BioCon 500 eee in the first path or second path In the third path and fourth path a user cannot interrupt the calibration Context Menus 58 CUBEscan 5 Last Calibration Date 2009 01 01 18 00 Calibrating the BioCon 500 1 The First Path Co
8. A female patient 4 Apply the ultrasound gel Apply the ultrasound gel on the patients abdomen above about 3 4cm above pubic symphysis 5 Aim toward bladder Put the ultrasound probe on gel applied to the patients abdomen and aim at the location the bladder is expected to be in 43 CUBEscan 5 IMPORTANT When you put the probe on the patient s abdomen be sure that the switch of the probe places on the right side of the patient IMPORTANT Conditions to degrade the accuracy of the measurement When a patient has had supra pubic or pelvic surgery A patient with catheter in his or her bladder A patient with scar sutures staples or incisions in his or her abdomen Air gap between probe head and the skin of the patient Use of the probe with unclean probe head Use care when scanning in above conditions 6 Locate the bladder with the Pre Scanning function Press switch to start Pre Scanning and start displaying the prescan image on the main display The position where the bladder image is largest and most centered is the optimal place to start the scan process 44 CUBEscan m 5 Real Time Ultrasound Image Fig 9 Pre Scan Screen IMPORTANT The Pre Scan is executed only when Prescan Enable in setup menu is ON When Prescan Enable is off a normal scan will be executed the button is pressed on Top Screen 7
9. After locating the optimal scanning location press the SCAN button to start the bladder scan The screen during normal bladder scanning is as follows 45 CUBEscan 5 Scanning Calculating Urine Volume Fig 10 During Scan Screen 8 Verify the scan results and rescan if needed After a normal scan results will be displayed on the main display as follows Areas 2 Battery Status Plane Number Horizontal Plane Out of Scan Sagital Plane Range Mark 2 Aiming 0 Information 210ml Current Current Ready to scan Scan Value Maximum Scan Value Context Menus in a Session SCAN S RESET PLANE 7 SAVE Fig 11 Scan Results Screen In the aiming information in the Scan Results Screen if the crossing of the aiming lines is not well centered on the bladder contour you must re aim and scan again Also verify the bladder image and the detected bladder contour are in line with each other If needed re aim and scan again 46 CUBEscan BioCon 500 How to re aim To the legs of the patient To tne right of the patient To the lett of the patient To the head of the patient Fig 12 Diagram for re aiming 47 CUBEscan 5 9 Review save and print scan results To review other planes press PLANE option on the Scan Results Screen To save the scan results press SAVE option on the Scan Results Screen To print the scan results press o
10. The Setup Screen will display as follows Position Cursor In Setup Screen Setup Menu Setup Value P Clinic MCUBETECH Set Date Time 2007 10 10 15 00 Print Option Raw Image Flash Store On Setup Print ien Scan Result B Mode Pis Auto Power 7 minutes Options Calibration Return Prescan Enable On Exit Context Menus MDOWN MUP 1 SELCT E EXIT P Fig 16 Setup Screen 2 With the selection cusor to the left of Clinic Name press JENTER SELCT option The Clinic Name Input Screen will be displayed as follows Clinic Name Input Window Title lt lt Input Clinic Name gt gt 225 Cursor Position Cursor In Screen Keyboard Screen Keyboard A C D E F G H I N Q R S T U V W X X Z 0 1 2 3 4 5 6 Backspace Space RCURS INPUT E EXIT P Fig 17 Clinic Name Input Screen Context Menus 52 CUBEscan m 5 These items displayed the Clinic Input Screen a Title Input Clinic Name gt gt b AClinic Name Input Window c ASoftware Keyboard d And Contextual Menu Options Within the software keyboard the bottom keys have special function Number Screen Keyboard Function 1 Backspace Delete one character Same function as backspace key on a computer s keyboard 2 opace Blank character 3 DONE Save the current clinic name shown in Clinic Name Input Window and return to Setup Screen 4 Delete all char
11. Tong Wook Kim Jeong Seok Seo Sang Kuk Yang Usefulness of a Sonographic Bladder Scan for Uroflowmetry and the Evaluation of the Anxiety Level Associated with Uroflowmetry The Korean Journal of Urology 2007 48 06 633 637 Chung B Lee T YangJH The Diagnostic Value of Portable Bladder Volume Measurement BVMS with Real Bladder Image in the Measurement of Bladder Volume According to the Different Angling of Transducer The Korean Journal of Urology 2006 47 06 1320 1326 Bodker B Lose G Postoperative urinary retention in gynecologic patients Int Urogenecol J Pelvic Floor Dsyfunct 2003 14 94 97 McNaughton Collins M Barry MJ Managing patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia Am J Med 2005 118 1331 9 100 CUBE scgan BioCon bOO Mcube Technology Co Ltd Room 803 Shinnae technotown 485 Sangbong Dong Chungnang Gu Seoul 131 220 Korea Tel 82 2 3421 7780 Fax 82 2 3421 7076 E mail mcube mcubetech co kr Web site www mcubetech co kr MUM BioCon 500 Rev 5 1
12. a qualified technician Inspect the transducer and cable prior to using the device Do not use if the transducer or cable is damaged Use the device within operating conditions specified in chapter 10 Environmental conditions Do not use the device with any defibrillator at the same time Use accessories only recommended by Mcube Technology Do not use if the transducer that has been immersed beyond the specified cleaning or disinfection level CUBEscan 5 WARNING The device should be used with ultrasonic gel either applied on the probe or patients abdomen Thus users should avoid using this device on patients with skin disease or injury Power Cord Make sure the power cord is the correct type for your area The equipment has a universal power adapter that allows operation at either 100 120V AC or at 200 240V AC without the need for user adjustment Always use a hospital grade power cord with the correct plug type The cord must be rated for 125VAC at 15A and be of type SJT or better Adapter The device complies to the above standards only when used with the power cord included Only use adapters supplied by Mcube Technology see chapter 9 4 Specification of adapter Computer connection When connecting the BioCon 500 to a computer the computer must be certified to EN IEC CSA UL 60950 or 60101 1 standard to maintain the device s compliance to EN IEC CSA UL 60601 1 1 standard Transmiss
13. completed the data will be displayed on the PC as follows 76 CUBEscan 5 Face Connected Uploaded rem Cubescan df Tod Wido eb x Coan flim Patient a gt lt F gp Scan Date Time 07 01 25 11 54 34 Measured Volume 305 E 6 Enter the patient information and save the contents using Save button cubeScanPC USB Connected Uploaded from CubeScan File Tools Window Setup Help Scan Aim Patient John Doe Save Patient ID 148199 Age 34 Sex M Scan Date Time 09 10 27 16 19 49 Measured Volume 290 ml Plane Number Area crr 7 Refer to Printing the Scan Data for printing IMPORTANT If the BioCon 500 is powered off without saving the scan data into the flash rom it will not be saved and will be lost Be sure to save the data that is intended to be uploaded to a PC 77 CUBEscan BioCon 500 6 7 2 Upload All Saved Scan Data This function is used to upload all the stored data in flash memory 1 2 3 4 5 6 7 Check the connection status between PC and the BioCon 500 in title bar Click File in a menu bar Click Upload All Saved Images CubeScan USB Connected mje setup Help Open Upload Upload All saved Images Delete All
14. of the Screen Keyboard under the position cursor except in case of bottom line of the Screen Keyboard 28 ENTER Change the selected Setup Item option to the option on the display and save the Setup Item option to the flash ROM And go to Setup Menu 29 30 ODOWN Show the next option downward for the current Setup Item Show the next option upward for the current Setup Item 5 5 7 0 5 22 Combined Switches Number Combined Function Active states Switches 1 ENTER Brightness Up Top Screen Scan Results Screen NO TI Z ENT TI ZU DOWNI Brightness Down Load Screen Scan Results Screen 3 ENTER LEFT Change Image Contrast Load Screen 42 CUBEscan m 5 5 3 Measuring Urine Volume 1 Charge Battery Charge the battery by connecting the AC Adapter to the AC main and to the console 2 Turn on the system Turn the system on by pressing and holding POWER switch for more than 1 second Then you can see the Top Screen as follows Date amp Time Battery Status 2008 10 10 PM 03 00 Software Version CubeScan Version X XX MCUBE TECHNOLOGY Clinic Name Sex Context Menus SCAN S P_ID J LOAD SETUP Fig 8 Top Screen 3 Select patient type Select patient type by pressing LEFT switch SEX option on Top Screen Each time a user presses the LEFT switch the patient type mark will be changed H a Amale patient
15. screws using a screwdriver Remove the battery cover IMPORTANT When removing the battery cover be careful to not bend the cover Pull out the battery using the strap on the battery Insert the new battery When inserting the top side of the battery the side having LED should be down facing the bottom of the unit and the strap on the battery should be be facing outwards battery cannot be properly installed if the orientation is incorrect avoid the risk of explosion only use batteries 22 CUBEscan 500 recommended by Mcube Technology CAUTION Never use excessive force to install the battery 4 2 Changing the Thermal Paper Open the printer cover as shown to the left Pull out the empty bobbin With the printer paper in one hand unroll a small length of the paper and insert into the unit as shown Close the printer cover after inserting the paper CAUTION Be sure to insert the paper the correct orientation To avoid damaging the system Only use thermal paper recommended by Mcube Technology Only print when the thermal paper is correctly loaded 23 CUBEscan BioCon 500 4 3 Charging the Battery Module of the BioCon 500 Connect an AC cord to a DC adapter The picture shows an adapter with the AC cord properly connected Connect the DC jack to the adapter terminal of the console he pricture shows a console with the pr
16. storage space for each session s scan data 67 CUBEscan r BioCon 500 6 3 2 Installing Software 1 Insert the software CD into the CD ROM drive 2 Double click CubeScanPC_Setup exe file in the root folder of the CD a Preparing setup dialog will be displayed as follows CubeScanPC InstallShield Wizard ug ES Preparing Setup Please wait while the Installshield Wizard prepares the setup InstaliShield b setup language click Next Choose Setup Language Select the language far the installation tram the choices below 68 CUBEscan r BioCon 500 C Initial screen for installation Click Next remm Welcome to the InstallShield Wizard for CubeScanPC The InstallShield Wizard will install CubeScanPC on your computer continue click Mest d Customer Information Dialog Please enter your name and company name Then click Next CubeScanPC InstallShield Wizard Customer Information Please enter your information Please enter your name and the name of the company For which vou work User Mame Stew Company Name Technos Instalishield CUBEscan r BioCon 500 e Ready to start Installation You are ready to start installation Click Install to continue Ready to Install the Program The wizard is ready to beg
17. 10 Buttons and their Contextual Menu Abbreviations The context menus in bottom line of the display is shown like this ENTER E ENTER is a context menu and E is the abbreviation for the button to press to activate the ENTER option Tactile switch Abbreviation in context menu S Ulo IEEE 2 2 A IGH NTE P i E m The membrane button on the probe has the same function as the SCAN button 60 CUBEscan 5 5 11 Summary of Each Screen and its Context Menus Following table summarizes each screen s contextual menus in the system Name em 1 Function otart Pre Scan or normal scan in a new session 2008 10 10 PM 03 00 Change the patient type MCUBE TECHNOLOGY Screen To review saved data goes to the Load Screen SETUP 1 To change the patient ID CubeScan Top Version X X goes to the Patient ID Input To setup system options goes SETUP to the Setup Screen During Scanning Scanning Calculating Urine Volume Activate the normal scan Pre Scan Screen Stop the Pre Scan and return to the Top Screen Start Pre Scan or normal scan in the current session Exit the current session and ocan return to the Top Screen Results PLANE Displays the next two plane Screen images SETUP Goes to the Setup Screen RESET PLANE
18. 2 5 3SEPHNGTBHEDATES 54 5 8 CUSTOMIZING OTHER SETUP 55 5 9 CALIBRATING THE BIOCON 500 USING THE CALIBRATION 4 57 5 10 BUTTONS AND THEIR CONTEXTUAL MENU 6 2 2 60 5 11 SUMMARY OF EACH SCREEN AND ITS CONTEXT 05 61 5 12 SUMMARY OF MENUS NOT SHOWN ON CONTEXT MENUS cccccccccccccccccccceccucuueccucueucueeues 65 6 THE OPTIONAL 66 6 1 5 inc oet avara ae 66 6 2 ML E D n moved EN 67 6 3 INSTALLING CUBESCANPC SOFTWARE ccccccceccceccccccccuceccucueccuuecuucueuauuceveueueueccuueuevanenas 67 6 4 UNINSTALLING 00 0 72 6 5 DEVICE DESCRIPTION i eer bei eave ER e isto ees 14 6 6 GETTING STARTED 14 6 7 USE OF THE SOFTWARE eie iet emt e bh onc et e ela une 76 6 8 SF TNC POU E O OANE O 81 7 TROUBLESHOOTING
19. A 2004b Health Canada Guidelines for the safe use of diagnostic ultrasound Cat H46 2 01 255E Ministry of Public Works and Government Services Canada 2001 IEC IEC 60601 1 Medical Electrical Equipment Part 1 General Requirements for Safety International Electrotechnical Commission 2004 UL 60601 1 Medical Electrical Equipment Part 1 General Requirements for Safety Underwriter Laboratories Inc 2003 CSA C22 2 601 1B 90 Medical Electrical Equipment Part 1 General Requirements for Safety Canadian Standards Association 2006 IEC IEC 60601 2 37 Medical electrical equipment Part 2 37 Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment International Electrotechnical Commission 2007 ISO ISO 10993 1 Biological Evaluation of Medical Devices Part 1 Evaluation and 99 CUBEscan 5 Testing 2003 FDA Guidance Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers 2008 FDA Guidance General Principles of Software Validation Final Guidance for Industry and FDA Staff 2002 IEC IEC 61157 Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment International Electrotechnical Commission 2007 MDD 93 42 EEC Medical Device Office for the Official Publications of the European Communities 2003 Woo Sung Hong Sun Young Ham
20. CUBEscan BioCon bOO User Guide M Man Machine amp Medicine cubed Mcube Technology Co Ltd CUBESCAN BioCon 500 Bladder Volume Measurement System User Guide CAUTION Federal Law restricts this device to sale by or on the order of a physician e Information in this User Guide may change at any time without notice Examples of ultrasound images in this User Guide are fictitious and do not in any way represent real patient data For up to date user information contact your local distributor or mcube mcubetech co kr Non Mcube Technology product names be trademarks or registered trademarks of their respective owners Manufactured by Mcube Technology Co Ltd Room 803 Shinnae Technotown 485 Sangbong Dong Chungnang Gu Seoul Korea 131 220 Tel 82 2 3421 7780 Fax 82 2 3421 7076 E mail mcube mcubetech co kr Table of Contents 1 etm 1 2 GENERAL 024 2 2 1 INDICATIONS FORSE sseodpem 2 22 CONTRAINDICATIONS ccccescscccescsecesscececsesecsesessssevsuesersstessssesseseussseeaueversssevretersesevereeenteees 2 DO ESAN ic sedate ter bacs a 2 lt QP a T Rr ee 3 25 SAFE HANDLING PROCEDURES FOR 14 26 WSER INTERFACE IGON DEEINITIONS G
21. Probe prior to disinfection oO Dampen a soft cloth with disinfected solution listed in the table below O Wipe the probe with a dampened cloth Air dry or towel dry with a soft clean cloth D Inspect the Probe and the cable for any damage such as cracks WARNING avoid electric shock disconnect the system from the AC mains and the battery CAUTION e Do not immerse the console or the probe Disinfectants Lists for the Probe disinfection Use any glutaraldehyde based disinfectant to disinfect the Probe Following table lists compatible disinfectants Disinfection Type Country of Origin Manufacturer oolutions Cidex 7 USA Johnson amp Johnson Metricide 14 USA Metrex Research Inc Metricide 28 USA Metrex Research Inc CAUTION e Do not use Cidex Plus or Metricide Plus 30 to disinfect the device Cidex Plus or Metricide Plus 30 will attack and damage the plastic enclosure This will be considered as abuse and will void the warranty 8 5 Weekly Inspection a Try to scan with the probe disconnected check if the NO SCANHEAD message is displayed on the main display b Thoroughly inspect the probe for cracks or leakage 84 CUBEscan 5 Inspect the probe cable for any damage d When scanning check for any abnormal noise emanating from the probe head 8 6 Device Repair Faults not described in section 7 Troubleshooting are intended to be serviced by a ce
22. SETUP 1 Saves the results of the SAVE Current session 61 CUBEscan 5 Load Screen Erase Confirm Screen Patient ID Input Screen Setup Screen 2007 10 10 13 00 255ml PID 1234567890 INO PAPER ERASE PLANE 2007 10 10 13 00 PID 1234567890 255ml To erase Press PRINT Key To cancel Press LEFT Key ERA SE un ci ic cR eee CANCEL ERASE P LCURS 0123456789 NDOWN LCURS NDOWN RCURS RCURS EXIT MDOWN gt Clinic Name MCUBETECH Set Date Time 2007 10 10 15 00 Print Option Raw Image Flash Store On Setup Print MUP Scan Result B Mode Auto Power 7 minutes Calibration Return Prescan Enable On Exit SELCT MDOWN SELCT E EXIT 62 Goes to the Erase Confirm Screen Displays the next two plane images Display next saved session Return to the Top Screen Print the current data Cancel the erasure Erase current saved session data Move the selection cursor to the left Increase the value above the cursor Decrease over the value above the cursor Move the selectrion cursor to the right Return to the Top Screen Move the selection cursor downward Move the selection cursor upward Select the current option for customization Return to the T
23. acters in Clinic Name Input Window 3 Edit the clinic name by using the displayed keyboard To move around the keyboard use LEFT UP Down RIGHT These switches are not specified in Contextual Menu Options IMPORTANT Pressing PRINTI EXIT option will cause the system to return to the Setup Screen without saving the name 4 After editing the clinic name press ENTER with selection cursor under the DONE option on the keyboard 53 CUBEscan 5 5 7 Setting the Date amp Time 1 Press SETUP option on the Top Screen 2 With the selection cursor to the left of Set Data Time press ENTER SELCT option The selection cursor in the Setup Screen will be moved to the right as shown below Position Cursor In Setup Screen Clinic Name MCUBETECH Cursor Set Date Time 200 Print Option Raw Image Flash Store On Setup Print Scan Result B Mode Auto Power 7 minutes Calibration Return Prescan Enable On Exit Context Menus LCURS NUP 7 NDOWN RCURS ENTER E Fig 18 Setup Date Time Screen 3 Changing the date and time is done through using the contextual options To move the cursor use LCURS option or RCURS option To change the numeric data above the cursor use NUP option and DOWNI NDOWN option 4 When done editing the date and time save the changes using JENTER ENTER option The position curser will return to the left of the screen
24. adjusted by selecting the Auto Power option in Setup Menu The device will not power on without a battery installed When measuring the urine volume of a patient ensure that the probe s button is on the right side of the patient When using the system on a medical cart ensure that the cart is placed on a flat and level surface The safe level of immersion for the probe is marked by the border between the cap of the probe and the body of the probe Do not immerse beyond the B portion of the probe illustrated in the figure to the left Only use the transducer which shipped with your unit The transducers are not interchangeable between units They are calibrated to a specific machine If changing the 12 CUBEscan m 500 probe associated with a machine it is necessary to calibrate the two prior to deployment 13 CUBEscan 5 2 5 Safe Handling Procedures for Transporter Quarantine Packages that are crushed punctured or torn open to reveal contents should not be placed into deployment Such packages should be isolated until the shipper has been contacted provides disposition instructions and if appropriate arranges to have the product inspected and repacked spoiled Product In the event that damage to packaging results in damage to the battery causing released electrolyte the spill should be contained and the shipper should be contacted for instructions 2 6 User Interface I
25. art Part C D Assembly Page 5 6 Title Assembly order UT ia a m O A Part All Assembly Page 8 Murad Meube Technology Co Ltd 30 CUBEscan r BioCon 500 BioCon 500 Rolling Cart Title Part 5 Legs Assemb MS 01 Part A ASSEMBLY Hub 1 1 Put a leg with caster into the Hub and then assemble the Hub by using wrench washer blot with a 5mm Hexagon wrench 2 Assemble the rest 4 legs in the same way af amp s 25mm bmm Hexagon Wrench e Machina M 31 CUBEscan BioCon 500 BioCon 500 Rolling Cart Title Fart B Basket Assembly 02 Part B ASSEMBLY Basket plate JEA 1 Put the Basket plate to Lower column from bottom side to top side as shown in the picture 2 Settle the Basket plate to Lower column by using Wrench washer blot 3 Unfasten the handle of Plate and fix into the hook of basket s upper side Wrench washer bolt 2 then fasten the handle of Plate M4 X 10mm If you don t need basket keep it separately Chart basket TEA Lowercolumn TEA GG GG 3mm Hexagon Wrench A Tap hole of the Lower column and circle of Basket plate should be aligned Maa Fahne A Bs Mul Technology Ca Ltd 32 CUBEscan BioCon 500 BioCon 500 Rolling Cart Title Part C Shelf holdr Asse
26. ate direct contact between the transducer output face and the patient Inclusive modes Make a note of the Inclusive Modes for this particular declaration which are not being declared separately 93 CUBEscan m 5 9 4 Specification of Components Item Features Power AC 100 240V 50 60Hz Model MW160 KA1641F52 16V DC 2 8A Adapter or GTM21097 5012 12V DC 4 17A Comply with UL 60601 1 Battery Pack Li18S Battery cell Li ion rechargeable 2P 2S Scan 4 hours 1 scan in every 15sec Battery Standby 6 hours Charging time Fully charging a completely discharged battery may take up to 10 hours sector scan 2 8MHz ultrasound frequency Ultrasound Probe B mode scan image scan angle 120 water resistance rated at IPX1 only probe Diameter 14mm Resonant frequency 2 8MHz Transducer Bandwidth minimum 40 at 6dB Penetration depth normal patient 18cm Thermal printer Built in 57mm width 5 6 STNLCD Display 320x240 pixels 16 gray levels Bladder volume range 0 999ml Range Accuracy 15 15ml 0 999ml External Interface USB 2 0 basic 94 CUBEscan m 5 Classification of Class equipment protection against Type BF equipment electric shock Main body Ordinary equipment Probe rated at IPX1 Water resistance Mode of operation Continuous operation Dimension 375 L x240 W x116 H
27. con Definitions Symbol Meaning Indicates a male patient LI eS Indicates a female patient W TIT Indicates a battery more than 75 charged TT Indicates a battery 50 75 charged Indicates a battery 25 50 charged Indicates the battery 1s near depletion or depleted J a 3 Indicates a battery 5 25 charged 14 CUBEscan 5 3 3 1 INTRODUCTION Product Description BioCon 500 is a portable ultrasound system intended to measure the volume of urine in a patient s bladder BioCon 500 transmits ultrasound signals into the abdomen of a patient and receives the echoed signals Using the echoed signals the system determines the bladder s outline and calculates the volume of the bladder based on the outline BioCon 500 has Pre Scan function which shows a live ultrasound image of a horizontal planar cross section of the bladder found by using the echoed signals The Pre Scan function helps in locating the bladder and improving accuracy user can print the results using a built in thermal printer immediately after measurements are taken Also using the optional CubeScanPC software one can upload saved data device s flash ROM to a computer for later review of the images oc Sy ncm 4 Fig 1 BioCon 500 System Front View 15 CUBEscan BioCon 500 16 CUBEscan 5 3 2 System Components 3 2 1 Packaging list Part nu
28. cube Technology certified service technicians SETTING UP The BioCon 500 function is only available to service engineers and technicians This User Guide covers the basics of installing CubeScanPC software and using the upload function between the BioCon 500 and a PC The following information is covered in this manual e Warning statements e Intended use e PC requirements Installation Operation Technical data 66 CUBEscan 5 6 2 Intended Use This CubeScanPC software is intended to allow scan image data to be uploaded to a PC from the BioCon 500 The uploaded scan data be reviewed maintained and filed on a PC Additionally it may be printed from a PC BioCon 500 The BioCon 500 is a B mode ultrasonic device that is intended for the measurement of residual urine volume The device automatically calculates the volume using ultrasound images from a three dimensional sector probe The BioCon 500 saves scan image data for up to 5 sessions 6 3 Installing CubeScanPC Software 6 3 1 PC Requirements Recommended PC requirements are as follows Operating system Windows e Processor Pentium 111 2 minimum Main memory 256MB minimum e Hard disk minimum 100MB free space e CD ROM minimum 10x Monitor Resolution minimum 1024 768 e Keyboard and Mouse USB port USB1 1 or USB 2 0 IMPORTANT There is an additional need of about 282KB of
29. d elevational lengths if different centimeters the derated pulse average intensity at the point of maximum reported MI Watts per square centimeter The Peak Rarefactional Acoustic Pressure is the maximum of the modulus of the negative instantaneous acoustic pressure expressed as a positive number mWicm2 The maximum value of the temporal average derived intensity in an acoustic field For systems in combined operating mode the time interval over which the temporal average is taken is sufficient to include any period during which scanning may not be taking place User selectable system settings which may include Application SV and Focal Length 90 CUBEscan 5 Wpbe 11 Wpb6 CL Prr Srr Output beam b dimensions Fawf This is the distance from the transducer output face to the point of maximum pulse pressure squared integral or max mean square acoustic pressure for continuous pressure for CW This is the 6dB pulse beam width in the beam axis X at the point of max pulse pressure squared integral or max mean square acoustic pressure for continuous pressure for CW If the beam widths in X and Y differ than less than 1096 there is no need to specify both For scanning modes the beam widths shall correspond to the central scan line only This is the 6dB pulse beam width in the elevational axis Y at the point of max pulse pressure squared integral or max mean square acoustic pr
30. dd or Remove Programs Currently installed programs Sort Change or FA CubeScanPc Size 0 48MB Remove Programs Click For support information Used rarely Last Used On 3 12 2007 gt To change this program or remove iE from your computer click Change or Remove Add Mew Programs Add Remove windows Components 72 CUBEscan r BioCon 500 5 To confirm click Yes CubeScanPc InstallShield Wizard 71 hy F Do you want to completely remove the selected application and all of its Features 6 Status dialog will be displayed as follows CubeScanPC InstallShield Wizard Setup Status CubeScanPC is configuring your new software installation C Program Files Mcube T echnology CubeScanPC CubeS can exe z p 7 e InstallShield 7 To finish click Finish CubeScanPC InstallShield Wizard Uninstall Complete InstallShield Wizard has finished uninstalling CubeS canPC InstallShield CUBEscan m 5 6 5 Device Description 6 5 1 Parts Lists Parts list included along with this software is as below e This User Guide 1 CD with CubeScanPC Software 1 USB cable 6 5 2 System Schematics CubeScan BioCon 500 IBM Compatible PC Fig 20 System Schematics 6 6 Getting Started Connecting to the BioCon 500 1 Connect the BioCon 500 with a USB cable to a PC wh
31. ed Enter the desired facility name 4 Click OK Handshake Mode does not have any effect on the operation of the CubeScanPC Software currently IMPORTANT Facility name used here is independent of the one in Device Configuration menu and is only used for printing purposes Facility name in Device Configuration is saved in the BioCon 500 and not impacted by this option 81 CUBEscan m 5 7 TROUBLESHOOTING 7 1 Troubleshooting Error message BATTERY LOW NO PAPER NO SCANHEAD ERROR IN CABLE CONNECTION Battery low Printer Error Connection Error Transducer circuit open Actions Use again after charging the battery IMPORTANT To lengthen the lifetime of the battery charge the battery when it is around 20 charged 1 Ensure the printer cover is closed If the cover is open close the cover and try printing again 2 Check if the thermal paper is empty If there is no paper insert a new roll of paper and try printing again 3 If the above steps do not successfully solve the problem contact an authorized Servicer Check if the connection between the probe and the console is secure If the above does not successfully solve the problem contact an authorized servicer Contact an authorized servicer 82 CUBEscan 5 8 8 1 Battery Care Do not overcharge the battery and avoid deep discharges To lengt
32. eese 14 S NARODU OTON 15 3 1 PRODUC DESCRIPTION 15 3 2 SYSTEM COMPONENTS a cececscececsecscesseccesectetsetesssstessesesssessssessseveseteseserssseeiseveneseeeses 17 3 3 NONA NO Na eo ture nostra 18 SET gt EA EEA EAA 22 4 1 INSTALLING OR REMOVING THE BATTERY scscesessscsesescecsctecsccessesevesesesesevsssevtsesevseseesesees 22 4 2 CHANGING THE THERMAL 23 4 3 CHARGING THE BATTERY MODULE OF THE BIOCON 500 M sese 24 4 4 CONNECTING THE PROBE TO THE SYSTEM cee ecccceccccecssecsessecevssesesecevssesesesesesevresensesenens 26 4 5 ROLLING CART ASSEMBLY uecesccccceccccsccescececcesececscessececeessesuscesussstauacesesstacasesesetavecereesesees 27 5 TO DS Sean Reduce EE V Ea Era s EAM E LE E 38 5 1 IN E PRORSUS RN HE 38 5 2 DEVICE CONTROLS AND CONTEXTUAL 8 222 0 40 53 es a base Ed rn 43 5 4 CHANGING THE 2200 eere ce e re c 49 J OADINGTHE SAVED DATA cro tese sd etw cua ru e ume iR 50 5 6 SETTING THE CLINIC 5
33. eparation distance calculated from the equation applicable to the frequency of the transmitter CUBEscan 5 Radiated RF 3 V m 3 V m Recommended separation distance IEC 61000 4 80 MHz to 80MHz to 3 2 5GH 2 5GH Z Z J 74 d Sawa 80 MHz to 800 MHz E1 d WP 800 MHz to 2 5 GHz E1 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 should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At 80MHz 800MHZz 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 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 10 CUBEscan 5 considered If the measured field strength in the locat
34. er Put the ultrasound probe on gel applied on the patient s abdomen and aim to bladder location expected Important Vvhen you put the probe on the patient s abdoment be sure ta that the SCAN switch of the probe places on the right side of the patient pubis bladder Locate the bladder by Pre Scan function Press SCAN switch ta start Pre Scan then user can see the Pre Scan Screen Important The Pre Scan is executed only when Prescan Enable in setup menu is OR Em Scan Result Screen The position the bladder image is the biggest will be the right position to start normal scan After locating the bladder position press SCAN switch to start normal scan erty the scan results and retry if needed Important hen Prescan Enable is off normal scan will be executed if a user press SCAN switch on Top Screen Save and or Print E gt lt Scan Results Screen Tel 82 2 3421 7780 Man Machine amp Medicine E mcubetemcubetech co kr Mcube Technology Co Ltd www mreuhetech co kr 38 CUBEscan BioCon 500 BioCon500 User quick Reference Horizontal Plane Number Plane Out of Scan Sagital Plane Range Mark Aiming information 210ml Current 2 55m Current Ready to scan Sean Value Maximum Scan Value Context Menus in a Session patient To the right of the patient the left of the patient P To the head
35. essing EXIT option after editing the patient ID 49 CUBEscan 5 5 5 Loading the Saved Data Press RIGHT P D menu on the Top Screen The Load Screen will be as follows Plane Number Aiming Information 2007 10 10 13 00 PID 1234567890 Urine INO PAPER Volume Context Menus ERASE PLANE J NEXT 1 PRINT P Error Message Fig 14 Load Screen The following information will be displayed on the Load Screen a Two plane images oO Areas for two planes images Measurement date amp time Patient ID Urine Volume Plane number gt 0 g Aiming information To review next saved data press NEXT option To browse other planes press PLANE option To print current loaded data press PRINT option To return to Top Screen press TOP option To erase current loaded data press ERASE option 50 CUBEscan m 5 The following is an Erase Confirm Screen In this screen to cancel press LEFT CANCEL option To confirm the deletion of the current data press JPRINT CFIRM option Plane Number Urine Volume 2007 10 10 13 00 CN PID 1234567890 255 Erase Confirm Aiming Notice Information To erase Press PRINT Key To cancel Press LEFT Key Context Menus CANCEL CFIRM P Fig 15 Erase Confirm Screen 51 CUBEscan 5 5 6 Setting the Clinic Name 1 Press SETUP option on the Top Screen
36. essure for continuous pressure for CW If the beam widths in X and Y differ than less than 1096 there is no need to specify both For scanning modes the beam widths shall correspond to the central scan line only Pulse Repetition Rate is the rate of successive pulses or tone bursts and applies to single element non scanning systems and automatic scanning systems Scan Repetition Rate is the rate of the same identical point of successive frames sectors or scans and applies to automatic scanning systems modes only Output beam dimensions are the dimensions of the ultrasound beam 6dB pulse beam width in a specified direction normal to the beam alignment axis and at the transducer output face In scanning modes these shall refer to the center scan line only The Arithmetic mean Acoustic Working Frequency is the arithmetic mean of the frequencies f1 and f2 at which the amplitude of the spectrum of the acoustic signal first becomes 3dB lower than the peak amplitude 91 CUBEscan 5 Acoustic Power up Fraction is the ratio of the peak rarefactional acoustic pressure when the system is in Power up mode to the maximum value of the peak rarefactional acoustic pressure for any system settings of a specified mode of operation This ratio is determined from measurements made at the position which yields the maximum pulse pressure squared integral or maximum mean square acoustic pressure for CW Air Acoust
37. ff PRINT button Depends on the system state 7 SCAN button Depends on the system state During pre scan and or scan operation the yellow lamp will turn off regardless of the charging state 19 CUBEscan BioCon 500 Fig4 Right side view of the console Terminal for USB connection with a 1 USB terminal computer 2 Probe terminal Connects a probe to a console Fig5 Left side view of the console Terminal for adapter connection to 1 Adapter terminal console Fig 6 Rear view of the console Handle Can be used to facilitate carrying 2 Battery cover Cover for the battery compartment 20 CUBEscan 5 3 3 2 Ultrasonic Probe Fig 7 Ultrasonic probe and cable No Item Function Remark Transmits and receives ultrasound 1 Probe cap signals 2 Cable Connects the probe to console Connects the ultrasonic cable to the 3 Connector console The same function as a SCAN button on 4 SCAN button the console 21 CUBEscan m 500 4 SETUP 4 1 Installing or Removing the Battery The battery is installed in a bay in the BioCon 500 When changing the battery or removing the battery for storage follow these instructions Power off Disconnect accessories WARNING e To 1 Turn the system off 2 Disconnect all connections from the console Loosen the two
38. hen the battery s lifetime use the system while the battery is between 25 75 The BioCon 500 does draw power from the battery even while powered off To avoid deep discharge disconnect the battery from the system if it will not be used for more than a week When storing the battery pre charging to about 759 is recommended 8 2 Changing the Battery Modules see 4 1 Installing or removing battery 8 3 Changing the Thermal Paper see 4 2 Changing the thermal paper 8 4 Cleaning amp Disinfection 8 4 1 Cleaning 1 Cleaning outer case housing of the system a Wipe the main body using soft cloth dampened with isopropyl alcohol or any other appropriate hospital cleaning solution Do not allow liquids to leak into the device while cleaning b Thoroughly dry the device with a clean soft cloth before re deployment 2 Cleaning the probe Cleaning the surface of the Probe a Disconnect the Probe from the system b Wipe the probe cap using a soft cloth dampened with isopropyl alcohol or an appropriate hospital cleaning agent c Then wipe with water dampened cloth d Dry with a soft clean cloth WARNING avoid electric shock disconnect the system from the AC mains and the battery 83 CUBEscan m 5 CAUTION Do not immerse the console or the probe Do not use harsh corrosive chemicals e g hydrochloric acid bleach 8 4 2 Disinfection 1 Disinfection of the Probe Q Clean the
39. ic Power up Fraction is the ratio of the peak rarefactional acoustic pressure when the system is in Initialization mode to the maximum value of the peak rarefactional acoustic pressure for any system settings of a specified mode of operation This ratio is determined from measurements made at the position which yields the maximum pulse pressure squared integral or maximum mean square acoustic pressure for CW Maximum power This is the Maximum Temporal Average power output For scanning modes this shall be the total power output of all the acoustic pulses lob mW cm Output Beam Intensity is the temporal average power output divided by the output beam area Power up mode With the probe connected cycle power on the system Write down the mode to which the system powers up Usually it is mode Initialization mode Write down N A where it denotes system settings do not change on new patient entry Acoustic output Write down YES if the system is supplied with an freeze output freeze facility ltt Transducer to Transducer output face distance is the distance along the beam alignment axis between the surface containing the active face of the transducer or elements and the transducer output face usually the lens thickness 92 CUBEscan BioCon SOO lts Transducer Standoff distance is the shortest distance between the transducer output face and the patient entry plane The term contact is used to conn
40. ile the BioCon 500 is powered off 2 Click START button of Windows 3 Click ALL PROGRAM 4 Click Mcube Technology 5 Click CubeScanPC The initial screen is shown below 74 CUBEscan r BioCon 500 ra File Setup Help 6 Turn the BioCon 500 on After powering on the program s title bar should be changed into as below USB Connected 2 EE File Setup Help WARNING there is no sign of connection after the BioCon 500 has been powered on for more 1 minute make sure that the connections are correct and secure and retry If there is still no message of connection the device may need servicing 7 The connection is established when the USB state is Connected CUBEscan BioCon 500 6 7 Use of the Software 6 7 1 Upload the Scan Data This function is used to transfer session scan data from the BioCon 500 1 Check the connection status between PC and the BioCon 500 in title bar It should read USB Connected 2 Click File in a menu bar 3 Click Upload CubeScan USB Connected 18122 setup Help Open Ctrl 0 Upload Upload All Saved Images Delete All saved Images Print setup ubebatavw blz20111125 cs CubeDatatt0hl 130196453 cs 061150195549 4 dmCubebatawtbl zb i cs Exit 4 During upload a status dialog will display the progress of the upload 5 When
41. ility The BioCon 500 has been tested and found to comply with the electromagnetic compatibility EMC limits for medical devices as set forth in IEC 60601 1 2 2001 These limits are designed to provide reasonable protection against harmful interference in a typical medical installation CAUTION To reduce the performance degradation of this device use medical devices that comply with IEC 60601 1 2 EMC Standards in the vicinity Do not use this device simultaneously with devices having high EMI levels e Electrostatic discharge ESD is a commonly occurring phenomenon especially when the humidity 15 low Electrostatic discharge can cause damage to the transducer or the system The following procedures can be useful in reducing the likelihood of ESD anti static spray on carpets anti static spray on linoleum and anti static mats 2 4 3 1 Manufacturer s declaration electromagnetic emissions The BioCon 500 is intended for use in the electromagnetic environment specified below The customer or the user of the BioCon 500 should assure that it is used in such an environment Immunity test Electromagnetic environment guidance RF Emissions Group 1 The BioCon 500 uses RF energy only for its CISPR 11 internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF Emissions Class A BioCon 500 is suitable for use all CISPR 11 establishments
42. in installation Click Install to begin the installation If pou wank to review or change any of pour installation settings click Back Click Cancel to exit the wizard f Setup status dialog will be displayed during installation as follows CubeScanPC InstallShield Wizard Setup Status CubeScanPe is configuring your new software installation Installing C 5Program FilessMcube TechnaelaggsCubes canFC Eubescan Chs dll 70 CUBEscan r BioCon 500 g Finish dialog Setup is successfully completed Click Finish CubeScanPc InstallShield Wizard InstallShield Wizard Complete The InstallShield wizard has successtullu installed CubeScanPC Click Finish ta exit the wizard InstallShield 71 CUBEscan BioCon 500 6 4 Uninstalling Software 1 Click on start in Windows 2 Click control panel 3 Click Add or Remove Programs in control panel Control Panel File Edit Wiew Favorites Toole Help Back a Search Folders Address gt Contral Panel Control Panel p i catego ry g Switch En Classic view E Printers Appearance and Themes Other See Also Hardware Windows Update muse n Network and g Help and Support Internet User Accounts Connections Date Time Language and Regional Options Add or Remore Programs 4 Click Remove for remove of CubeScanPC program A
43. into the hole of part B s upside Wrench washer bolt M4 X Mmm Wrench washer bolt Mi X 25mm 3mm Hexagon Wrench Tool M Check the direction after Part B assembling Hexagon Wrench Tool ge Marching Wadi e Meube Tech 60 OOOOH x Ex IT isa nology Ca Ltd 35 CUBEscan BioCon 500 BioCon 500 Rolling Cart Title Part All Assemhi ITEMS 06 Part All ASSEMBLY Upper column Assembly 1 Put the Upper column Assembly to Bottom Assembly hole properly aie Bottom Assembly 1E 2 Lock up using the lock handle ffyouassemble the Lock handle first Upper column Assembly might not be inserted Meuba Technology Ca Ltd 36 CUBEscan r BioCon 500 BioCon 500 Rolling Cart Title How to use the rolling Cart Handle Dimensions 0610 X 1167 Weight 11 5kg Mcube Technology Co Ltd Room 803 Sr arabes Techindtawr Shape ane ungnang Tel 82 2 3421 7780 E mail mcube mcubetech co kr Meabe Technology o Ltd 37 CUBEscan m BioCon 500 5 HOW TO USE 5 1 Quick Guide BioCon500 User quick Reference Power Buttan 1 m Turn On The System 2 Press Power Button More Than 1 Second Select Patient Type Function Button Scan Button Print Button Apply Ultrasound Gel Aim Toward Bladd
44. ion which the BioCon 500 is used exceeds the applicable RF compliance level above the BioCon 500should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the BioCon 500 b Over the frequency range 150kHz to 80MHZz field strengths should be less than V m 11 CUBEscan 5 244 Equipment Safety To prevent damage to the system and or accessories observe the following cautions CAUTION D gt lt gt 1 dirty transducer can degrade the accuracy of the system Clean the transducer with a soft cloth dampened in a mild soap or detergent Dropping a transducer or impact on a transducer can cause the system to malfunction or be inaccurate Do not drop or shock the transducer To avoid damaging the cable or transducer connector handle them with care Do not immerse the system or the transducer beyond the level in specified in 8 4 Cleaning amp Disinfection If the system is not likely to be used for more than a week charge the battery up to about a 75 charge level remove the battery module from the device and store it according to storage conditions of the battery This step will help maximize the lifetime of the battery See chapter 10 Environmental conditions The device has a setting to power down automatically if not used during a specified time period This setting may be
45. ion of data When transmitting data to or from a computer make sure that the BioCon 500 any accessories and the computer are at least 2 meters or 6 5 feet away from the patient CUBEscan 5 2 4 2 Battery Safety BioCon 500 uses a Lithium ion battery pack To ensure safe use of the battery observe the following warnings and cautions If there are any problems with the battery module immediately discontinue use of the battery and contact Mcube Technology or your local distributor WARNING The battery module has built in safety mechanisms Do not disassemble or tamper with the battery pack e Only use the charger that is supplied with the Unit Contact Mcube Technology or your local distributor for replacements Do not charge the battery outside of the recommended conditions as it may damage the battery resulting in possible leakage of the electrolyte or explosion see chapter 9 4 Specification of adapter Charge the batteries only when the ambient temperature is between 10 C 40 50 104 F in door use Do not short circuit the battery Short circuiting the battery may cause rapid heating resulting is possible explosion To avoid short circuiting do not let the battery come in contact with metal objects at any time especially when transporting Only use the manufacturer s recommended battery Do not connect the battery in reverse polarity Do not charge the battery in reverse
46. istance z and is equal to 4 YWJylu z where Ira z is the temporal average intensity as a function of z centimeters 89 CUBEscan m 5 fc Dim of Aaprt PD PRF Pr Pllmax deqg PI Imax FL lpa 3 MI max ISPTA System settings is the center frequency MHz For MI f is the center frequency associated with the transmit pattern giving rise to the maximum reported value of MI For for combined modes involving transmit patterns of unequal center frequency f is defined as the overall range of center frequencies of the respective transmit patterns the active aperture dimensions for the azimuthal and elevational planes centimeters the pulse duration microseconds associated with the transmit pattern giving rise to the reported value of MI the pulse repetition frequency associated with the transmit pattern giving rise to the reported value of MI Hz the peak rarefactional pressure at the point where the free field spatial peak pulse intensity integral is a maximum megapascals See Section 6 2 4 1 of the Output Display Standard entitled Measurement Methodology for Mechanical and Thermal Indices the equivalent beam diameter at the point where the free field spatial peak pulse intensity integral is a maximum centimeters See Section 6 2 5 1 of the Output Display Standard entitled Measurement Methodology for Mechanical and Thermal Indices the focal length or azimuthal an
47. mber Description 3110100037 2 8MHz 4110100719 Hospital grade NEMA 5 15 4110100069 Model MW160KA1641F52 4110100744 alert ower Supply Or Model GTM21097 5012 4110100718 Built in 57mm width 2 rolls 4110100714 Gel Ultrasound transmission gel 5110100009 User guide 3 2 2 Optional components Part number Description 3110100032 Optional Po upload sotware CO CubeScanPC setup CD 5110100028 PC upload software CD Optional 4110100018 Li18S 4110100070 USB A B cable 1 8M Optional 17 CUBEscan 5 3 3 Functions of Each Part Indicator amp PC Interface ct LCD Display Input Control 320x240 LCD Control Main Control Unit Printer Control E Analog Plane Step Transaction Motor Step Unit AD Angle Step Control Motor Thermal Printer Ref This connection is used with optional CubeScanPC software Fig 2 System Diagram excluding power supply 18 CUBEscan m BioCon 500 3 3 1 Console 9 p Pry Fig 3 Front of the console No Item Function Remark LCD Displays menus and information 2 Thermal printer Prints out the measured data Green lamp left Adapter connection status On Adapter connected 3 Indication lamp Off Adapter disconnected Yellow lamp right Charging status On Charging 4 c Depends on the system state amp arrow buttons 5 button Turns the system o
48. mbly ITEMS 03 Part ASSEMBLY Sa EEN 1 Fix the Adapter with Adapter holder the Main Body Holder Adaptor holder TEA When you are doing this operation you can only use the adapter which was Probe holder provided with the BioCon 500 Gal holder 4EA 2 Assemble the Probe holder and Gel holder Domtassonie roverso orehangeay 0000 M4 X Emm JX EN HEN ro e 3mm Hexagon Wrench 1 7 piace the Probe and Gel properly as ike picture Picture 02 v Fives Mcube Technology Ca Ltd 33 CUBEscan BioCon 500 BioCon 500 Rolling Cart Title Part D ITEMS 04 Part D ASSEMBLY Main Body holder asmi 1 Assemble the Upper column to the Main Body holder Assembly as a proper ii direction like posture m washerbolt 4EA pari doing this operation you should be careful about the assemble M X 8mm 3mm Hexagon Wrench IN Caution Aftar assembling if you lay down to right side Holders can be bent Man Mus Megha Technology Co Ltd 34 CUBEscan BioCon 500 BioCon 500 Rolling Cart Title Part E Bottom Assembly ITEMS 05 Part E ASSEMBLY B Lag Assembly TEA 1 Put the part B assembly to Part A assembly in the proper direction then fix the Basket Assembly TEA part B assembly by using B03 amp BOS bolts Spring TEA 2 Put the spring
49. mm Language English Accuracy According to the scanning instruction and scanning on a Mcube Technology tissue equivalent bladder phantom Battery operation time For a new battery module fully charged Tested on Mcube Technology s test conditions 95 CUBEscan 5 10 ENVIRONMENTAL CONDITIONS 10 4 BioCon 500 1 Operating conditions Condition Ambient temperature range Relative humidity Atmospheric pressure range 2 Storage conditions Condition Ambient temperature range Relative humidity Atmospheric pressure range Description 10 40 50 104 F 30 75 non condensing 700hPa 1060hPa Description 10 60 C 14 140 F 20 80 non condensing 600hPa 1060hPa CAUTION f you are not using this device more than a week please disconnect battery from the device Store the battery in accordance with the recommended conditions 96 CUBEscan m 5 10 2 Battery Module 1 Battery Storage Conditions Condition Description 10 30 C 50 86 F lt 1 Year Ambient temperature range 10 45 50 113 F lt 3 Month 10 60 50 140 F lt 1 Month Relative humidity 20 80 non condensing Atmospheric pressure range 600hPa 1060hPa CAUTION Prior to storing the battery charge it to about 75 97 CUBEscan 5 11 GLOSSARY B Mode A kind of ultra
50. mpleted 2 The Second Path Completed 3 The Third Path Calibration has failed ERROR First Path Not Enough Water EC1 CSTART E Context Menus Last Calibration Date 2009 01 01 18 00 Calibrating the BioCon 500 1 The First Path Completed 2 The Second Path Completed 3 The Third Path Completed 4 The Fourth Path Completed Calibration done sucessfully 2009 02 01 19 00 CSTART E Context Menus lf there are any errors during calibration the main display will show the message Calibration has failed ERROR First Path Not Enough Water EC1 In the error message First Path means the calibration steps when the system detected any error during calibration Not Enough Water means additive information about the error state This additive information is displayed for only EC1 error 1 means the error code during calibration The screen when the calibration is done successfully The date and time when the calibration is done successfully is displayed the bottom part of the LCD screen IMPORTANT The BioCon 500 returns to the top screen when the calibration process is terminated or stopped To leave the calibration screen press the down key only effective in the first and second path of the calibration process for more than 5 seconds or turn off the system by pressing the power key 59 CUBEscan m 5 5
51. n the Scan Results Screen PLANE option is not displayed on the context menus in bottom part of LCD IMPORTANT During one session a user may scan more than 1 time In this case the scan results with the largest urine volume will be saved and printed case there are multiple scans with the same urine volume the most recent will be saved and printed e f a user saves twice in same session the data that was previously saved will be overwritten Only one data set will be saved per each session e BioCon 500 can save up to 5 scans e Ifa user saves more than 5 scans the oldest scan will be overwritten with the newest scan data 10 Finish scan After finishing the scan wipe the ultrasound gel off the patient and the probe 48 CUBEscan m 5 5 4 Changing the Patient ID 1 Press ID menu on the Top Screen Then a user can see the Patient ID Input Screen as follows Patient ID 0123456789 Cursor Context Menus LCURS NUP 1 NDOWN RCURS EXIT P Fig 13 Patient ID Input Screen 2 Change the Patient ID To move the cursor press LEFT ECURS option or IRIGHT RCURS option To change the value at the selection point press NUP option or DOWN NDOWN option IMPORTANT The patient ID consists of 10 digits The patient ID is not saved in flash ROM so after restarting the system the patient ID will be reset to 0000000000 3 Go to Top screen by pr
52. n to currently displayed value IMPORTANT Upload Screen will be shown during upload the data to the computer There is no active menu in Upload Screen Start calibration Return to the Top Screen CUBEscan 5 Setup Calibrating Screen Setup Calibration Error Screen Setup Calibration Completion Screen Stop the calibration process A the calibration during step 1 and Last Calibration Date 2009 01 01 18 00 Calibrating the BioCon 500 1 The First Path Completed 2 Tne Second Path user stop step 2 Press and hold DOWN seconds to stop calibration for more than 5 STOP Retry the calibration process ast Calibration Date 2009 01 01 18 00 Calibrating the BioCon 500 1 The First Path Completed 2 The Second Path Completed 3 The Third Path Over Return to the Top Screen Calibration has failed ERROR First Path Not Enough Water EC1 CSTART E Retry the calibration process Last Calibration Date 2009 01 01 18 00 over Calibrating the BioCon 500 1 The First Path Completed 2 Tne Second Path Completed 3 The Third Path Completed 4 The Fourth Path Completed Return to the Top Screen Calibration done sucessfully 2009 02 01 19 00 CSTART E 64 CUBEscan 5 5 12 Summary of Menus not Sh
53. of the patient m oo eet Diagram For Re aiming ee Tel 82234217780 Mica den fueras ene mcube amp emcubetech co kr Ai Mcube Technology co Ltd www mcubetech co kr 39 CUBEscan m 5 5 2 Device Controls and Contextual Menus BioCon 500 has 8 buttons on the main console Only one of the buttons IPOWER has fixed functionality It is used for turning the system on or off The other 7 buttons navigate the contextual menus and have varying function Contextual Menus in the bottom part of the display consist of an option and a corresponding button For example SCAN S means that the option is SCAN and a tactile switch is SCAN Table below explains the context menus and system state Switch SCAN PRINT we ne pern Screen SCAN 5 LOAD SETUP P_ID E Setup EXIT MUP MDOWN SELCT Screen co oc ue unen Scan SCAN PRINT RESET SAVE SETUP PLANE Results PSCAN ocreen Pre Scan Screen Bm ooo Load RINT ERASE NEXT PLANE Screen Basse me nac Erase CFIRM CANCEL Confirm screen Clinic RCURS EXIT MLEFT MRIT MUP MDOWN INPUT Name Input Screen Patient ID EXIT NDOWN Input Screen Setup NUP mame ee Setup OUP ODOWN ENTER Other Option 40 CUBEscan m BioCon SOO Screen Upload Screen Context menus marked not di
54. op Screen CUBEscan 5 lt lt Input Clinic gt gt Clinic A B C D E F G H I J K L M Name N O P R S T U V W X Y Z Input 012 3 45 67 8 9 amp Screen Backspace Space DONE Clear RCURS INPUT E Clinic Name MCUBETECH Set Date Time p 2007 10 10 15 00 Print Option Raw Image Setup Flash Store On Setup Print Scan Result B Mode Date Time Auto Power 7 minutes Calibration Return Prescan Enable On Exit LCURS NDOWN RCURS ENTER E Clinic Name MCUBETECH Set Date Time 2007 10 10 15 00 Print Option Raw Image Other Flash Store On Setup Print Scan Result B Mode Options Auto Power 7 minutes Calibration Return Setu Prescan Enable On p Exit ODOWN ENTER E Upload System is in upload state Screen ast Calibration Date 2009 01 01 18 00 Setup Calibration Top Screen CSTART E 63 5 Move the selection cursor to the right Select the letter above the selection cursor Return to the Setup Screen Move the selection cursor to the left Increase the value above the cursor Decrease over the value above the cursor Move the cursor to the right Save the date and time Browse to the next option upward Browse to the next option downward Set the optio
55. oper connection to the DC jack Connect the AC plug to a grounded socket 24 CUBEscan 5 6 Check the color indicator on the console Green indicator Tells that the adapter connected and AC power is present The system is ready to charge and be operated Yellow indicator Denotes that the system is charging When the battery is fully charged the yellow indicator goes off Fully charging the battery may take up to 10 hours WARNING e Only use Adapters recommended by Technology To avoid electric shock only use sockets with a ground pin 25 CUBEscan BioCon 500 4 4 Connecting the Probe to the System 1 Find the white mark on the connector of the probe 2 Align the probe cable to the probe terminal with the white mark CD on the probe connector up After aligning push the probe cable straight in until there is a click sound To disconnect the probe from the console grasp the black plastic ring 2 on the probe connector and pull out 3 Check to make sure the connection is secure 26 CUBEscan BioCon 500 4 5 Rolling Cart Assembly BioCon 500 Rolling Cart Rolling Cart Assembly Manual z Man Marking d ETT Techaalogy Ca Ltd 27 CUBEscan r BioCon 500 BioCon 500 Rolling Cart Rolling Cart Part List inis PAGE HUMOR Main body holder 4110100153 se 411010041671 Plate
56. other than domestic and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes armoni emissions os BEEN CUBEscan 5 Voltage fluctuations Flicker emissions IEC 61000 3 3 2 4 3 2 Manufacturer s declaration electromagnetic immunity The BioCon 500 is intended for use in the electromagnetic environment specified below The customer or the user of the BioCon 500 should assure that it is used in such an environment Immunity test Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 IEC 60601 Test level 6kV Contact 8kV air 2kV for power supply lines 1kV for input output lines 1kV differential mode 2kV common mode Compliance level 6kV Contact 8kV air 2kV for power supply lines 1kV for input output lines 1kV differential mode 2kV common mode Electromagnetic environment Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment CUBEscan 5 Voltage dips lt 5 UT lt 5 UT Mains power quality should short gt 95 di
57. own on Context Menus There are menus which were not shown on context menus but have its function in that screen Following table summarizes those menus and their functions in each screen Print the results of the current scan Results Screen PRINT PRIN session Move the selection cursor to MLEFT LEFT the left Move the selection cursor to MRIT RIGHT Clinic Name Input Screen the right MUP Move the selection cursor up Move the selection cursor MDOWN DOWN down 65 CUBEscan 5 6 THE OPTIONAL SOFTWARE CubeScanPC 6 1 Skip this part if you do not or use the optional CubeScanPC software General Information Copyright 2007 Mcube Technology Co Ltd All rights reserved The contents of this manual are the property of Mcube Technology Co Ltd Any reproduction in whole or in part is strictly prohibited This manual correctly describes the software and its functions at the time of publishing of the CD ROM However as modifications may have been carried out since the production of this manual the device package may contain one or more addenda to the manual This manual including any such addenda must be read before using the software The following situations void any guarantee s and obligations of Mcube Technology The software is not used according to the enclosed manuals and other accompanying documentation The software is installed or modified by persons other than M
58. p in UT gt 95 dip in UT be that of a typical interruptions and for O 5cycle for 0 5cycle commercial or hospital voltage 40 UT 40 UT environment If the user of variations 60 dip in 60 dip in UT the BioCon 500 requires on power supply for 5 cycle for 5 cycle continued operation during input lines 70 UT 70 UT power mains interruptions IEC 61000 4 1 1 30 dip in 30 dip in it is recommended that the for 25 cycle for 25 cycle BioCon 500 ultrasound lt 5 UT lt 5 UT system be powered from an lt 95 dip in Ur lt 95 dip in Ur uninterruptible power supply for5s for5s or a battery Power frequency Power frequency magnetic 50 60 2 fields should be at levels magnetic field characteristic of a typical IEC 61000 4 8 location in a typical commercial or hospital environment NOTE UT is the a c mains voltage prior to application of the test level 2 4 3 3 Manufacturer s declaration electromagnetic immunity The BioCon 500 is intended for use in the electromagnetic environment specified below Users of the BioCon 500 should ensure that use occurs in such an environment Immunity test IEC 60601 Compliance Electromagnetic environment test level level Conducted 3 Vrms 3 Vrms Portable and mobile RF communications RF 150 kHz to 150 kHz to equipment should be used no closer to any IEC 61000 4 80MHz 80MHz part of the BioCon 500 including cables 6 than the recommended s
59. polarity as it may cause the battery to rapidly heat swell or even explode Do not use a battery pack when something appears abnormal Such unusual smell deformation discoloration etc If electrolyte leakage occurs do not touch the liquid If it should come into contact with the skin or eyes immediately seek help from a doctor e Ifthe battery does vent avoid any contact with the smoke Do not expose the battery to water moisture or any type of liquid Do not use or store the battery in temperatures above 60 CUBEscan 5 WARNING CAUTION IMPORTANT or next to any heat source Doing so can cause the battery pack to swell and explode Do not abuse the battery pack Doing so can cause damage to the battery resulting in a potentially unsafe situation When connecting the battery module to a console be careful about polarity Be sure to securely fasten the battery cover Long term storage If the system is not likely to be used for more than a week remove the battery module from the device and store it according to the recommended storage conditions See chapter 10 Environmental conditions To lengthen lifetime of the battery module it is recommended to charge up to 75 and to discharge to 20 If the battery pack lasts less than 5 minutes after a full charging replace the battery with a new one CUBEscan m 5 2 4 3 Electromagnetic compatib
60. rtified technician In the event a situation outside of those described in the section occurs contact an authorized servicer or Mcube Technology for servicing 8 Disposal The device and accessories may contain environmentally hazardous materials mineral oil lead battery pack etc When they have reached the end of its useful service life return them to the Mcube Technology or follow your local regulations for hazardous waste disposal 85 CUBEscan 5 9 SPECIFICATIONS 9 1 Symbol Directory Symbol 0120 te 05 NN REF SN Description Type BF patient applied part B body F floating applied part Attention see the User manual Direct current DC Alternating current AC Degrees of protection against the ingress of water CE marked in accordance with the Medical Device Directive UL classification mark for Canada and the U S Collect separately from other household waste see European Commission Directive 93 86 EEC Refer to local regulations for disposal Date of manufacture Reference number Serial number 86 CUBEscan 5 9 2 Acoustic Output Table Transducer Model 2 8MHz Transducer Operating Mode B mode lt 1 gt 1 Global Maximum Index Value 0 307 0 002 0 002 i gt Gn Ce LLL min of P z ha z W s z1 lta a 21 Associated Acoustic Parameter z at max 2 m
61. rture Square centimeters the derated peak rarefractional pressure associated with the transmit pattern giving rise to the value reported under MI megapascals For TIB and TIC time average acoustic power at the source in milliwatts Also see the definitions for Wo Wo1x1 that follow For TIS scan WS W 1 Worx For TIS non scan We Wa For scanning modes and or scanning components of combinational modes time average acoustic power at the source per cm in milliwatts This is the acoustic power emitted from the central 1 cm length the scan direction of the aperture corresponding to the scanned pulses Wo1x1 For non scanning modes and or non scanning components of combinational modes time average acoustic power at the source cm in milliwatts This is the acoustic power emitted from the central 1 of the active non scanned aperture through which the highest acoustic power is being transmitted the derated ultrasonic power at axial distance z milliwatts the derated spatial peak temporal average intensity at axial distance 24 milliwatts per square centimeter the axial distance corresponding to the location of max min W 2 2 x 1 cm where 2 zy centimeters 1 69 JAaprt centimeters For the axial distance at which p 3 is measured for TIB the axial distance at which TIB is a maximum i e Zsp Zp 3 centimeters the equivalent beam diameter as a function of axial d
62. saved Images Print Setup 1 d wCubebDatawtbizlliil2z5 cs DoW 061130195459 cs 3 dmCubebatawtbi 130185348 cs 4 domCubebatawthbl13ll Exit During upload a status dialog will display the progress of the upload When completed the data will be displayed on the PC as shown in the single upload case In the multiple upload case each session will have a dedicated window Enter the patient information and save the contents using Save button for each window open The BioCon 500 can store up to 5 scanning sessions Refer to Printing the Scan Data for printing 78 CUBEscan BioCon 500 6 7 3 Deleting All Saved Scan Data This function is used to delete all saved data in the BioCon 500 o 1 Check the connection status between PC and the BioCon 500 title bar 2 Click File in menu bar 3 Click Delete All Saved Images CubeScan USB Connected HEU setup Help Open Upload Upload All Saved Images Delete All Saved Images Print Setup 1d wi ubeDataw bl201111257 cs bim ubeDatawwb1130195453 cs 3 dmi ubeDatawwrb51130195348 cs 4 dmi ubeDatawwnb511301 72b27 cs Exit 4 Dialog box for confirmation is presented When you press Yes all stored data will be deleted IMPORTANT Functionality that deletes individual stored datum is not yet implemented 6 7 4 Contrast Brightness Control Modifies the contrast and brightne
63. sound imaging mode Displays the brightness information corresponding to the amplitude of the signal Console The main device with the LCD display Contextual The menu displayed in the bottom of LCD based on the system menu state Session The time a user starts to scan on Top Screen to right before returning to the Top Screen again Transducer Device that transforms one form of energy into another form of energy Ultrasound transducer transforms electric energy into acoustic energy and vice versa Transducer in this guide means ultrasound transducer 98 CUBEscan 5 12 References AIUM Medical Ultrasound Safety American Institute of Ultrasound in Medicine Laurel MD 1994 AIUM Acoustic Output Labeling Standard for Diagnostic Ultrasound Equipment A Standard for How Manufactures Should Specify Acoustic Output Data Revision 1 American Institute of Ultrasound in Medicine Laurel MD 2008 AIUM NEMA Standard For Real Time Display of Thermal and Mechanical Acoustic Output Indices On Diagnostic Ultrasound Equipment Revision 2 NEMA Standards Publication UD 3 2004 American Institute of Ultrasound in Medicine Laurel MD National Electrical Association Rosslyn VA 2004a AIUM NEMA Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision 3 NEMA Standards Publication UD 2 2004 American Institute of Ultrasound in Medicine Laurel MD National Electrical Association Rosslyn V
64. splayed in bottom of the display 5 21 Functions in each context menu Number Context Function 1 Initiate a bladder volume scan 2 PSCAN Pre Scan for positioning the bladder 3 Toggle between male and female 4 Load the saved data 5 Go to setup menu 6 P ID Go to patient ID input screen 7 EXIT Go to previous system state 8 MUP Move the position cursor upward circular 9 Move the position cursor downward circular 10 Select the item selected by position cursor 11 Print scan results or loaded data according to system state 12 Clear the data in a current session and go to Top Screen 13 Save the data of current session to flash ROM 14 Show next two planes images and related numeric data 15 STOP Stop pre scanning and go to previous system state 16 ERASE Go to Erase Confirm Screen for erasing current loaded data 17 Erase current loaded data from flash ROM 18 Go to Load Screen without erasing current loaded data 19 Move the position cursor in Screen Keyboard to the left 20 MRIT Move the position cursor in Screen Keyboard to the right 21 MUP Move the position cursor in Screen Keyboard to upwards 22 Move the position cursor in Screen Keyboard to downwards 23 Move the cursor to left 41 CUBEscan 500 24 RCURS Move the cursor to right 25 Increase the value in current cursor curcular 26 NDOWN Decrease the value in current cursor curcular 27 INPUT Input the current character
65. ss of the image 1 Click on Tools in the menu bar 2 Select Brightness Contrast 3 A dialog box will display allowing for the adjustment of the brightness and contrast Brightness Contrast Control Brightness Contrast Use the slider bars to adjust the brightness and contrast using either a mouse or the 5 arrow keys 79 CUBEscan 5 IMPORTANT Tools menu is only available if a data file is open 6 7 5 Changing Image Size This function is used to modify the size of displayed image Available sizes are 50 75 100 and 200 1 Click on Tools in the menu bar 2 Select Image Size 3 Click on the desired size IMPORTANT Images will always print at 100 This will not impact the print size 6 7 6 Printing the Scan Data This function is used to print scan data from a PC to a printer 1 Click on Eile in the menu bar 2 Select the desired printer 3 Click Print IMPORTANT You can preview the layout through the Print Preview the menu bar 80 CUBEscan m 5 6 8 Setting CubeScanPC This is used to change the CubeScanPC s software settings The only available function is to input the Facility Name 6 8 1 Facility Name 1 Click Setup in the menu bar 2 Select CubeScanPC Setup CubeScan Setup Facility Mame cube Technology w USB Communication Cancel Handshake Mode 3 CubeScanPC Setup Dialog is display
66. tion Statement Caution Federal Law restricts this device to sale by or on the order of a physician CUBEscan 5 2 44 Safety This guide covers components function maintenance storage and precautions needed to use this system All users must read and thoroughly understand this entire guide prior to using the BioCon 500 This section has information on safe use of the BioCon 500 Electrical Safety Battery Safety EMC Electromagnetic Compatibility Equipment Safety WARNING e Risk of explosion To avoid the risk of injury do not operate the device in the presence of flammable gasses or anesthetics The hazard of potential explosion exists 2 4 1 Electrical Safety This device meets IEC 60601 1 Class Type BF isolated patient applied parts safety requirements This device complies with the applicable medical equipment requirements published in the Canadian Standards Association CSA European Harmonized Standards and Underwriters Laboratories UL safety standards Please review and follow the following safety warnings WARNING The power supply should be properly grounded The power supply must be connected to an AC socket that is medical grade or equivalent grounding pin must not be removed or tampered with Do not use the device if the power cord is damaged Do not open the device s enclosures All servicing except battery and printer paper replacement must be made by

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