VitaScan LT - Vitacon US
Contents
1. Microcontroller The microcontroller is the master in the IVBM VUFE module controlling all functionality and safety It is also a communication interface between the Probe and the computer The microcontroller is a Slave with respect to the computer and will only communicate in response to a command from the computer Microcontroller states of operation Power up At normal power up a self test and initiation procedure will start The FPGA configuration will be cleared and configuration must be downloaded from the computer before ultrasound acquisition may start The transducer element positions will be initialized At power up with the push button pressed the module will enter PROGRAM mode waiting for firmware upgrade via the USB connection This is a maintenance function and should only be used by trained service personnel Idle In Idle state the module is waiting for a command from the computer or the pushbutton The current consumption is reduced to an absolute minimum Pre Scan In Pre Scan mode the module will move the transducer sweep motor continuously between the end positions and ultrasound data for one vector will be transmitted to the computer at each defined position The rotation motor is parked in the initial position This will give the computer the possibility to present a live image of the bladder making it possible to move the VitaScan LT to the correct position before making a Full Scan with volu2. 1 Accuracy referred to measurements on Vitacon Phantoms only User and Service Manual Page 6 VitaScan LT VITA CON Product Upgrades and Updates Vitacon may offer software upgrades and new features that may improve system performance User and Service Manual updates explaining the effects of upgrades and new features on system performance will accompany the upgrades About the Ultrasound System The VitaScan LT System includes USB Probe Laptop and a Medical Isolation transformer For electrical safety reasons you should always power the Laptop from a Medical Isolating device PC Device Driver UBM Application Block API Interface VitaScan LT System Number Features Specification 1 USB Scanner VitaScan LT ae Laptop Computer Dell XPS M1530 Model 9928L or equivalent Medical Isolation Transformer Tripp Lite IS250HG or equivalent if mains operated Software version 4 5 0 or higher VitaScan LT 5 USB Memory stick With Software amp Documentation About the System Software The VitaScan LT system contains software that controls its operation Vitacon will provide you with a USB Memory stick containing the software Typically new software provides new capabilities User and Service Manual Page 7 VitaScan LT VITA CON Electrical Safety This system meets EN60601 1 Class and Type BF isolated patient applied parts safety requirements This system complies with the applicable medical equipment
3. Locate the bladder Press and release the scan button and hold the Scanhead steady throughout the scan Note While scanning avoid making any changes in the position angle or pressure of the Scanhead Regular Inspections and Maintenance VitaScan LT is a Medical Electric Equipment and therefore needs special precautions regarding EMC VitaScan LT needs to be installed and put into service according to the EMC information provided in the accompanying documents Vitacon recommends that the VitaScan LT be certified by an authorized VitaScan LT Service Center once a year Certification service includes a comprehensive inspection and testing of the instrument to ensure accurate measurement performance For more information please contact your VitaScan LT Service Center Or your local VitaScan distributor Weekly Inspections Once a week you should inspect the Scanhead and cable for physical faults or cracks Cracks that allow the leakage or ingress of fluid may affect the safety and or the performance of the instrument Any apparent faults or cracks must be referred to your authorized VitaScan Service Center or your local VitaScan distributor Monthly Accuracy Check Caution In the event of changes in the performance of the instrument discontinue use and contact your authorized VitaScan LT Service Center or your local VitaScan LT distributor User and Service Manual Page 12 VitaScan LT VITA CON Each month or whenever a
4. We advise new operators to use the VitaScan LT on patients with moderately full bladders rather than initially attempting to locate nearly empty bladders A Caution The VitaScan LT should not be used on a patient with open skin or wounds in the suprapubic region The patient should not have a catheter in his her bladder This could affect the accuracy of the measurement User care with suprapubic pelvic surgery patients Scar tissue incisions sutures and staples affect ultrasound transmission and reflection Accuracy may be affected for patients with ascites or free floating fluid in the peritoneum Indications for Use This manual is directed toward the reader who is familiar with Ultrasound techniques Sonography training and clinical procedures are not included here This manual is not intended as training material for the principles of ultrasound anatomy scanning techniques or applications You should be familiar with all of these before attempting to read this manual or using the device Product Features Real time Ultrasound Bladder Scanner 3D ultrasound scanner amp PC running Windows XP Windows Vista Windows 7 OS USB ultrasound probe connection Bladder volume calculations in large digits Storage of ultrasound images tte Unpacking and Inspection There are no special unpacking instructions but be careful not to damage the instrument when unpacking it When unpacking the VitaScan LT to check for damage duri
5. from the FPGA The amplified analog receive signal is low pass filtered by a passive L C filter before it is fed to the A D converter The A D converter is clocked from the FPGA Resolution is 12 bits and sampling speed is 12 5MHz The parallel output data is fed to the FPGA for further digital processing Safety Mechanisms The following safety mechanisms are implemented in the IVBM VUFE module TX Voltage and Input voltage monitoring Software Watchdog The microcontroller is supervising the voltages in the main loop for maximum safety and a watchdog is supervising the microcontroller program execution In case of a SW HW error that causes abnormal program execution a HW reset condition will occur and the High Voltage will be disabled The HW has a measurement circuit allowing the microcontroller to measure the High Voltage and the Input voltage The microcontroller will disable the TX Voltage if the voltage is out of the pre defined range 10 of set value and an error will be sent to the computer User and Service Manual Page 31 VitaScan LT VITA CON If the Input voltage is reaches the minimum value 4 2V an error message will be sent to the computer If the input voltage is too low to drive the IVBM VUFE a HW reset condition will occur and the High Voltage will be disabled Vitacon will upon request make available other technical documentation which will assist qualified technical personnel to repair the equ
6. physiological effects However ultrasound should be used only by a medical professionals when clinically indicated using the lowest exposure times possible commensurate with clinical utility The ultrasonic output power of the VitaScan LT is not user adjustable and is limited to the minimum level necessary for effective performance Data on acoustic output levels can be found in the section titled Technical Specifications in this manual It is recommended that users read the Health Canada Guidelines for the Safe Use of Diagnostic Ultrasound before using this or any other diagnostic ultrasonic device http Awww hc sc gc ca ewh semt alt_formats hecs sesc pdf pubs radiation 01hecs secs255 01hecs secs255 eng pdf note this link may change over time Statement of Intended Use The VitaScan LT projects ultrasound energy through the lower abdomen of the patient to obtain an image of the bladder This image is used to determine bladder volume noninvasively Contraindications The VitaScan LT is not intended for fetal use or pregnant patients A Warning Exposure of low power diagnostic ultrasound has not been shown to produce adverse effects However medical professionals should use ultrasound only when clinically indicated User and Service Manual Page 4 VitaScan LT VITA CON A Warning There is the hazard of possible explosion if the VitaScan LT instrument is used in the presence of flammable anesthetics First Time Users
7. problems are observed Do not use the VitaScan LT if its head or cable is damaged Do not use the VitaScan LT if there is evidence of leakage of internal liquids Wash hands immediately in warm soapy water Consult the MSDS on Polypropylene Glycol for additional information precautions To avoid the risk of electrical shock do not use any VitaScan LT that has been immersed in liquid Safety and Performance Summary The VitaScan LT computes the volume of the urinary bladder based upon twenty four cross sectional ultrasound images or less For maximum accuracy be sure to hold the Scan head motionless while scanning The most accurate measurements are obtained when the patient rests quietly in the supine position Accuracy is compromised if the user does not obtain an optimal repeatable image Errors in usage tend to result in the underestimation of bladder volume except in cases where the Scan head is moved during scanning In this case the measurement may overestimate the patient s bladder volume The patient being scanned should not have a catheter in his her bladder This could create micro bubbles in the bladder which affect the accuracy of the measurement Do not use the VitaScan LT on patients with open skin or wounds in the suprapubic region User and Service Manual Page 9 VitaScan LT VITA CON Use care when scanning suprapubic and pelvic surgery patients Scar tissue surgical incisions sutures and stapl
8. requirements published in the European Norm Harmonized Standards Underwriters Laboratories UL and the Canadian Standards Association CSA For maximum safety observe the following warnings and cautions A Warning To avoid the risk of electrical shock or injury do not open the system enclosure All internal replacements must be made by a qualified technician To avoid the risk of injury do not operate the system in the presence of flammable gasses or anesthetics To avoid the risk of electrical shock use only properly grounded equipment Shock hazards exist if the power supply is not properly grounded Grounding reliability can only be achieved when equipment is connected to a receptacle marked Hospital Only or Hospital Grade or the equivalent The grounding wire must not be removed or defeated Run Laptop on battery internal electrical source whenever integrity of the external protective earth conductor arrangement is in doubt To avoid the risk of electrical shock before using the VitaScan LT inspect the housing and USB cable Do not use the VitaScan LT if these are damaged To avoid the risk of electrical shock always disconnect the USB Cable from the PC before cleaning the system To avoid the risk of electrical shock do not use any transducer that has been accidentally immersed in any liquid or has been immersed in any liquid for cleaning or any other purpose To avoid the risk of electrical shock do not t
9. CC ACVOIIS TOG TSC eE E sean ciedvecesiesaunderonneeaniesavunaerstuentounuentreneionss 5 Produc US er sree scence dene ede E E E E ey 5 Unpacking and INSPECTION ccccccessccccesececcesececceuscceceusececeeseceeseeeceessuecessenecesseneceesenseeessunecetsunsesseges 5 COMPO TIO FCS Ci IS e E toned oavesn ceoniuaeteneumeenteaneeets 6 MOPE ere setrcsesss oan Sane nee T E onus secon scietaeg E E oeesecon see hea cues anemia anon ees E aaeaneuts 6 Fenaa sy EEC 12 9 b gt eee eee orn re en eine ee eee oe ee eee ee ee 6 PROCGUCE Upgrades and Update S acs cece rsencceanansssacenecuct een ENERE EEPE AIEE EEE 7 About the Ultrasound Syste M ssr RE 7 POO UE TVS y En ONE a E E E 7 ECO a e E E E 8 EaU SAG SO E sean scoadeceoressaensonseeceeaesaaneesseeeeveenyeainauecaeseenceaasaeesoas 9 Safety alae COP ia CE SUID ANY aecpiasersosadisesciecrsereesartaven sic veto newioeaius wee Veatsnarisiasantetsiatwnenee ca duceun use oatueaont uence 9 PPO INS yn OOS see ss sets cviocteoa E E co ceuteaasieoee db sinreeeacustioouet sevensnre arenas 10 Applicable STANGAlGS AD DKOVAlSxisi dainsnicsscuscccnswsodaeiebagnaudannsataiaoonnsepatesenasicbageiiedvansatiieboassiaeainsedbadicbutecedens 10 PO DIVINE the Ultrasound GC lecersasdne oannenedesaxecceserneecevanwoeedeetvoseseeenceae 11 Measuring Bladder VolUMiE Sear ee meee er teen ens ere ne ran eee ee 12 Regular Inspections ANd Maintenance ccecccccesseccceesececcesccceeesececeesececeeecceseusecessuneceesuecesseeeeee
10. CON Introduction VitaScan LT USB Ultrasound Bladder Monitor Real time bladder scanning is a safe and easy non invasive method to measure bladder volume Bladder scanning measures ultrasonic reflections within a patients body and differentiates the urinary bladder from the surrounding tissues The VitaScan LT is a B mode ultrasonic instrument portable and battery operated intended for the non invasive measurement of urinary bladder volume A mechanical sector scanning transducer provides cross sectional images of the bladder from up to twenty four scan planes Based on these images the VitaScan LT automatically calculates the estimated bladder volume in milliliters and displays it on a screen VitaScan LT is applicable in many clinical areas to determine bladder volume time for bladder emptying and detection of post void residual volume PVR A real time image of the bladder during pre scan makes it easier to detect the bladder before scanning Important Information Notice To All Operators The VitaScan LT should be used only by individuals who have been trained and authorized by a physician or the institution providing patient care All operators should read this manual prior to using the VitaScan LT Failure to comply with these instructions may compromise the performance of the instrument and the safety of the patient Biological Safety To date exposure to pulsed diagnostic ultrasound has not been shown to produce adverse
11. V shows the maximum volume from multiple measurements ReScan please shows when measurements are incorrect Clear Restart button will clear the screen and measurements Use Clear Reset button before scanning another patient The result can be saved by pressing Save This will generate an exact image of what you see including patient information and the volume result The default name for a saved file is a timestamp which will have the form 20100108 094853 This means the scan was done on the Date 2010 Jan 08 Time 09 48 53 You may change this to another name if desired My Recent Gacum Desktop My Documents My Computer File name 20111103 103331 Save Save as type Al png jpg jpeg bmp tif th ico emt Cancel The result can also be printed by pressing print It will give you the option to select a printer and chose if you want to print the picture in a landscape or normal orientation User and Service Manual Page 23 VitaScan LT VITA CON To load an old scan press load and select the scan you want to see It will load the picture from the hard disk Open Fe 20111103 103331 jpeg My Recent Docum My Documents My Computer File name 20111103 103331 jpeg Open Files of type All prig jpa jpeg bmp tif tiff ico emt Cancel Help To exit the application press Exit and Yes Scanning on Vitacon Phantom Before sca
12. VitaScan LT VITA CON VitaScan LT USB Ultrasound Bladder Monitor User and Service Manual Version 4 5 2 Date 09 November 2012 The Information contained in this user and service manual is proprietary to Vitacon It is only used for convenience of our customers It may be changed in whole or in part without written notice Any service work performed by persons who are not authorized by Vitacon may void your warranty User and Service Manual Page 1 VitaScan LT Disclaimer VITACON Vitacon provides this publication as is without warranty of any kind either express or implied including but not limited to the implied warranties of merchantability or fitness for any particular purpose Further Vitacon reserves the right to revise this publication and to make changes from time to time to the content hereof without obligation to Vitacon or its local representatives to notify any person of such revision or changes Some jurisdictions do not allow disclaimers of expressed or implied warranties in certain transactions therefore this statement may not apply to you Limited Warranty Vitacon warrants that the VitaScan LT USB Ultrasound Bladder Monitor will substantially conform to published specifications and to the documentation provided that it is used for the purpose for which it was designed Vitacon will for a period of twelve 12 months from date of purchase replace or repair any defective device if the fault is due to a
13. ccuracy assessment is desired or in question the accuracy of the VitaScan LT should be tested using the following procedure Take a Pre void measurement of bladder volume Void or catheterize into a measuring beaker Take a post void measurement of bladder volume to check for post void residual PVR Subtract the post void measurement form the pre void measurement and compare to the voided volume The measure volume should be within a range of 20 20ml of the voided volume Take a measurement on a Vitacon Phantom The measure volume should be within a range of 10 of reading 20 ml 12 month Regular Inspection and Maintenance Vitacon recommends that the VitaScan LT to be certified by an authorized VitaScan LT service center once a year Certification includes comprehensive inspection and testing of the instruments to ensure accurate performance in clinical use Customers can maintain device certification via Internet by accessing the VitaScan online integrity and filed calibration services For more information contact your local dealer Care Cleaning and Disinfecting Clean the VitaScan LT with a soft cloth soaked in a mild liquid detergent solution Rinse with clean water and carefully dry with a clean soft cloth Dampen a soft cloth with 70 ethanol Wipe the probe with the dampened soft cloth and let the ethanol evaporate If the VitaScan LT needs to be disinfected dampen a soft cloth in any glutaraldehyde ba
14. d User Account set to No Warning when installing new software Please read Windows 7 User Manual Short instruction of User Account Setting Open Control Panel select User Accounts Select Change Settings Drag the selection bar down to No Warning eee Installation of the VitaScan LT application Open the folder to view the VitaScan_LT_Installer files on the USB Memory stick Run the VitaScan_LT_Installer exe file Press Next VitaScan LT Install Program EJ as Welcome to the VitaScan LT Install program This program allows you to install VitaScan LT on your hard drive tis strongly recommended that before proceeding you ensure that no other Windows programs are running lf you do not wish to install VitaScan LT click Exit now otherwise click Next to continue User and Service Manual Page 14 VitaScan LT VITA CON The Next button will get enabled when user chooses to accept the license agreement terms and conditions License Please read the license agreement below Please read the license agreement below and select Agree if you agree with its terms and conditions END USER LICENSE AGREEMENT a Copyright amp 2005 2010 by Vitacon AS E All rights reserved License By using the enclosed program and or installing the files from the original disks to your hard drive you are agreeing to become bound by the terms of this agreement If you do not a
15. dimensional scanning of the bladder and the electronics to obtain the ultrasound image needed to calculate the volume of urine in the bladder both pre and post void The VitaScan LT probe is attached to the computer via a USB connection which also provides the necessary power to the probe This document only covers the technical specification for the probe electronics IVBM VUFE Overview The drawing below shows an overview of the complete VitaScan LT bladder scanner system All modules are physically located inside the VitaScan LT User and Service Manual Page 28 VitaScan LT VITA CON Vitascan LT Probe Analog Frontend FPGA Signal processing Micro Push button controller Sweep Rotation Block diagram for VitaScan LT Probe Functional Description The IVBM VUFE is a single element ultrasound scanner with the electronic module and scanning mechanics designed to fit in a hand held scanner having the following main functionality USB communication interface for computer Ultrasound Pulse generator Ultrasound receiver and signal processing Motor control and positioning of the ultrasound transducer element The module is realized in analog and digital hardware FPGA configuration and microcontroller firmware The following are the main parts of the design tee ee Microcontroller FPGA PSU USB Motor driver Analogue Receiver and transmitter User and Service Manual Page 29 VitaScan LT VITA CON
16. ent as of December 2011 with respect to the VitaScan LT The contents of this manual should not be considered to be all inclusive or covering all contingencies The physician s at your institution directing the use of the VitaScan LT is responsible for keeping current with developments in the literature on bladder volume determination Please direct any questions or problems concerning bladder volume measurement the use of the instrument or interpretation of data to the responsible physician s User and Service Manual Page 27 VitaScan LT VITA CON Service The Information contained in this service manual is proprietary to the Vitacon It is supplied solely for the convenience of our customers It may be changed in whole or in part without the written notice This manual is not intended as support for any unauthorized servicing disassembly rebuilding modification or resale of VitaScan LT by unauthorized third parties Introduction This section contains the IVBM VUFE technical specification and architectural design description IVBM VUEFE is the electronic module in the VitaScan LT bladder volume scanner VitaScan LT is a 3 dimensional ultrasonic scanning device used to measure the bladder volume and quantity of urine remaining in the bladder safely and comfortably through a non invasive method The VitaScan LT probe consists of mechanics and electronics The VitaScan LT contains the mechanical components needed to execute the 3
17. es can affect ultrasound transmission and reflection A Warning There is the possible hazard of explosion if the VitaScan LT is used in the presence of flammable anesthetics Labeling Symbols CE CE mark Notified body no 3 Test Agency Certification Mark North America BF type Body Floating WEEE Waste Electrical and Electronic Equipment Warning consult accompanying documents Read the documentation A Ultrasound radiation rx Drip proof wi Nr ky gt Dx ON Applicable Standards Approvals The Vitascan LT Bladder Monitor conforms with the following standards CSA C22 2 NO 60601 1 08 Medical electrical equipment Part 1 General requirements for basic safety and essential performance IEC 60601 1 Medical Electrical Equipment Part 1 General requirements for safety 1988 A1 1991 11 A2 1995 CSA C22 2 NO 60601 1 2A 03 R2006 EN 60601 1 2 2001 A1 2006 Medical electrical equipment Part 1 2 General requirements for safety Collateral standard Electromagnetic compatibility Requirements and tests IEC 60601 2 37 Medical Electrical Equipment Part 2 37 Particular Requirements for the basic safety and essential performance of ultrasonic equipment Ed 2 0 2007 08 ISO 14971 2007 Medical devices Application of risk management to medical devices US FDA 510 k market approval K121689 User and Service Manual Page 10 VitaScan LT VITA CON Apply
18. gree to the terms of this agreement uninstall all software and return all materials in o lagree with the above terms and do not agree Press Next It is recommended to install in the default directory Directory Choose an installation folder and click Next to continue VitaScan LTs files will be installed in the following directory C Program Files VittaScanLT Disk space needed 4 hlb Available disk space 13077 Mb Click Next to continue User and Service Manual Page 15 VitaScan LT VITA CON Press Start Confirmation You are now ready to install VitaScan LT This program will install VitaScan LT into C Program Files VitaScanLtf Click Start to install VitaScan LT Press Next End Installation completed VitaScan LT has been successfully installed User and Service Manual Page 16 VitaScan LT VITA CON Finish the installation by pressing Exit Clickteam Install Creator Copyright 1999 2006 Clickteam http www clickteam com This install program has been created with the freeware version of Clickteam Install Creator a simple and powerful install maker Wisi our Web site and discover Clickteam Install Creator as well as our game and multimedia creation tools PS the product you have just installed has not been created by Clickteam please directly contaci its author or publisher for any question about it After a succes
19. ing By default on power up the gender will be Male and Pediatric and Obese setting will be set to OFF Press the Male button to change to Female setting Press the Pediatric button to select pediatric setting The max detection depth changes from 16 cm to 10 cm The bladdersize will increase in the image NOTE This may take a few seconds Press the Obese button to select obese setting The max depth changes from 16 cm to 23 cm The bladder can now be detected a further distance from the VitaScan LT probe NOTE This may take a few seconds Press Pre Scan this gives a real time image of the bladder on the display Use Pre Scan to locate the bladder and aim the VitaScan LT directly above the bladder Murti ASO Spi MU ssdt Girmi LAN WiisSear l Scan Clear Restart A 5 ccc ue oe n lt 8 Max V 0 mi When you have located the bladder as in the picture above press Scan to start scanning NOTE Do not move the VitaScan LT probe until scanning is 100 done The results will appear as shown below The left picture shows the horizontal scan and the right picture shows the vertical scan The lower cross hair picture shows the top view of the bladder in yellow Male Pediatric Obese Pre Scan Clear Restart Curr V 128 ml Max V 128 ml User and Service Manual Page 22 VitaScan LT VITA CON Curr V shows the volume from the current scan Max
20. ing the Ultrasound Gel Palpate the patient s symphysis pubis pubic bone and apply the Gel immediately superior to the patient s symphysis pubis as shown in images below Or apply the Gel around the dome of the Scanhead Smooth the gel out and remove any air bubbles which may block ultrasound transmission Using Ultrasound Gel Pad Sometimes it may be convenient to use ultrasound transmission Gel pad The Gel pad is an easy to use coupling medium To apply the ultrasound Gel Pad peel back the foil lid of the individual gel pad package exposing the gel pad User and Service Manual Page 11 VITACON VitaScan LT Measuring Bladder Volume Palpate the patient s symphysis pubis and place the Scanhead midline on the patient s abdomen approximately 4 cm 1 5 inches superior to the symphysis pubis as shown in images below a a gt Scanhead Scanhead Scanhead f in S Patient s Patient s Patient s Patient s feet head R feet Right Symphysis N Symphysis va Bladder ba Scanline Scanline View from the Patient s Right Side N Pubis gt Pubis Scanline ae Scanline View from the Patient s Right Side View from the Patient s Feet Aim the Scan head so the ultrasound is projected toward the expected location of the bladder For most patients this means aiming the tip of the Scanhead toward the patient s COCCYX Press and release the scan button located on the Scanhead
21. ipment Repair should be performed only by Vitacon authorized service organization Copyright 2012 by Vitacon All rights reserved User and Service Manual Page 32
22. mable voltage for the motors to be used USB The USB controller is an integral part of the microcontroller The IVBM VUFE USB will be the SLAVE and the computer will be MASTER Implementation of the USB firmware follows the USB 2 0 standard Motor driver The motor driver is designed for running Stepper motors and consists of three parts A HW part that will transform logical control signals into currents driving the motors ASW part in the microcontroller that will keep track of position of each motor and generate logical control signals to move the motors to correct positions dependent on operating mode A HW HAL sensor and magnet to be used as a reference to calibrate sweep motor position The motor driver is designed to support Full step Half step and Micro step modes but for maximum motor torque the Full Step mode is used The motor supply voltage is made HW programmable to support different step motors Analog Receiver and Transmitter The transmitter is a bipolar square wave pulse transmitter The voltage level is settable to tree levels by software configuration data control The waveform is controlled by a sequence generator in the FPGA The input signal from the transducer is attenuated by a t r switch during the pulse transmit period The t r switch is controlled by a sequencer in the FPGA The receiving signal is amplified by a TGC amplifier chain The gain control signal is set by an analog ramp signal controlled
23. manufacturing defect In no event will Vitacon or its local representatives be liable for direct indirect special incidental or consequential damages arising out of the use of or inability to use the VitaScan LT USB Ultrasound Bladder Monitor even if advised of the possibility of such damages Vitacon or its local representatives are not responsible for any costs loss of profits loss of data or claims by third parties due to use of or inability to use the VitaScan LT USB Ultrasound Bladder Monitor Neither Vitacon nor its local representatives will accept nor be bound by any other form of guarantee concerning the VitaScan LT USB Ultrasound Bladder Monitor other than this guarantee Some jurisdictions do not allow disclaimers of expressed or implied warranties in certain transactions therefore this statement may not apply to you Contacting Vitacon In Europe Vitacon AS Vegamot 8 N 7048 Trondheim Norway http www vitacon com E mail sales vitacon com In North America Vitacon Medical Inc or 5355 Parkwood Place Richmond BC V6V 2N1 Canada E mail na sales vitacon com Copyright 2012 All rights reserved PN 6100 500 Vitacon US 5563 Pioneer Creek Drive Maple Plane Minnesota 55359 USA E mail info vitacon us User and Service Manual Page 2 VitaScan LT VITA CON Tables of Contents Va hua fo 0 O E ar aeen ee ere A E E ce ee ee eer 4 PTD ONC AIIE HVT OI AUG setae eseatictecohee tet aa E E E 4 A
24. me calculation Full Scan In Full Scan mode the module will move the transducer sweep motor from one end position to the other transmitting ultrasound data for one vector to the computer at each defined position The rotation motor will then move one step and a new sweep will be performed When the rotation motor has moved a total of 180 degrees and the computer has received a number of vectors defining a set FPGA The FPGA Field Programmable Gate Array is responsible for all signal processing in the IVBM VUFE module The microcontroller configures the FPGA with Bitstream data and configuration data received by the computer The microcontroller initiates an Ultrasound capture sequence by a Trigger signal The FPGA will generate an ultrasound pulse according to the configuration data receive the echo and send data for the vector to the microcontroller after signal processing PSU The PSU power supply unit in the IVBM VUFE module get its input voltage from the USB connection The computer will provide all power needed by the IVBM VUFE module including motors and transducer that are driven from this module The power consumption must be lower than the maximum rating of power to be provided by the computers USB port User and Service Manual Page 30 VitaScan LT VITA CON The PSU will provide 4 different voltages 1 2V FPGA 3 3V Microcontroller 5 0V Analog receiver Motor driver logic Motor HW program
25. n Windows XP Windows Vista Windows 7 operating system PC Software Application Key Features Manage patient scan image data Displaying images of patient s scans along with calculated urine volume Printable Report for a patient data Compatibility with Windows XP Windows Vista Windows 7 Operating Systems Rich Graphical User Interface and easy navigation VitaScan LT is configured to work for No Of Sectors To Scan 6 12 or 24 eeeoeoeoe Application Features Pre Scan image Scanned images Includes patient information with scanned images User and Service Manual Page 20 VitaScan LT Run VitaScan LT application Make sure the VitaScan LT probe is inserted in the computer port Press the VitaScan LT Icon on your Desktop to start the application 8 AE iian T Usund Bidda unita S50 Sap St ULL AE Merili Male Pediatric ae w DESE Pra Scan JAVE Load Print Setup Exit Before scanning select Setup to insert User information PC serial number VitaScan LT information and language Number of scans for each measurement may be set to 6 12 or 24 12 scans is the default value VitaScan LT Ultrasound Bladder Monitor St Olay T Phantom English biii wih adi Dai ai iadi PP PPP a hia T User and Service Manual Page 21 VitaScan LT Pre Scan is the first step used to locate the bladder Before starting the Pre Scan select the correct Gender Pediatric and the Obese sett
26. ng shipment Inspect the shipping carton for damage If the shipping carton is damaged carefully continue unpacking the instrument and note any dents and scratches on the VitaScan LT Save the damaged shipping carton and packing material for the carrier s inspection and contact the respective carrier If there is any damage on the scanner equipment contact Vitacon lf there is no shipping damage continue removing the VitaScan LT from the shipping case Save the box and packing materials they will be needed when returning the VitaScan LT to Vitacon for recalibration or future service Verify that all items listed on the packing list have been received and are in good condition User and Service Manual Page 5 VitaScan LT VITA CON Note This box contains specifically designed foam inserts to ensure safe shipment of the VitaScan LT Save these for future shipment of the unit for service or calibration Content of the packaging VitaScan LT probe USB Memory stick with Application Software and User amp Service Manual VitaScan LT probe holder Installation guide in English Storage If the system is to be stored pack it in the original container and keep it in an environment free of corrosive material fluctuations in temperature and humidity and vibration and shock Storage Requirements Storage temperature from 30 C to 50 C Relative humidity of 20 to 90 30 C non condensing Atmospheric pressure fr
27. nning on a Phantom enable the Phantom box under Setup The Phantom box is disabled as a default setting l e the Phantom box will be turned off when Setup is selected or the VitaScan LT application is started VitaScan LT Ultrasound Bladder Monito z ot Olay 31110001 20100 English g aaa TTT T Fe User and Service Manual Page 24 VitaScan LT VITA CON Other settings Enter Password 1234 to open other settings VitaScan LT Ultrasound Bladder Monitor St Olay E Phantom English g O Disable PreScan Timeout C Enable Data Logging SPP PPP eye PP eee SEPP EPP PP ey Disable PreScan Timeout Disables the 2 min PreScan timeout Enable Data Logging Enables automatic data logging of measurements Data is stored with a timestamp in the folder c programfiles VitaScanLT INSTALL LOG SCAN This option is normally only used for investigation of problems associated with image data User and Service Manual Page 25 VitaScan LT VITA CON Application Troubleshooting Installation message Driver not found gt Uninstall driver Open Control Panel Select User Accounts Select Change Settings Drag the selection bar down to No Warning Restart the computer Re install the driver VVVVV WV Device should be configured before running the application gt Incase of Windows XP OS the USB driver needs to be configured before the applica
28. om 700 hPa to 1060 hPa As with most electronic equipment the unit should be operated in a dry area within normal temperature limits 10 C to 45 C 10 80 humidity Dispose electronic waste VitaScan LT complies with the WEEE Directive 2002 96 EC marking requirements The affixed label indicates that you must not discard this Medical Electric Equipment in domestic household waste Product category With reference to the equipment types in WEEE directive annex IA this product is classed as category 8 Medical Devices To return unwanted products contact Vitacon at the address mentioned at the front of this manual or your local VitaScan distributor Technical Specifications Volume range 0 1000 ml Accuracy 10 of reading 20 ml Frequency 2 35 MHz Acoustic Output MI max 0 26 Limit 1 9 Thermal Index TI lt 0 02 Scanning method Sector 180 degrees Rotation positions 6 12 or 24 rotating positions Sweep angle 110 degrees Max detection depth 100 160 or 230 mm Max probe temperature 35 C 22 C ambient temperature Dimension Lx W x H 14 x 4 5 x 6 6 cm 5 5 x 1 8 x 2 6 in Weight incl cable 0 38kg 0 84lb IP rating IPX1 Power Supplied by USB port Operating conditions 10 C to 25 C 10 80 relative humidity Storage temperature 30 C to 50 C PC requirements Windows XP Vista 7 OS PC Input method mouse keyboard and touchscreen
29. ouch Laptop Computer output connector like USB port and others and the patient at the same time Caution Although your system has been manufactured in compliance with existing EMC EMI requirements EN60601 1 2 use of the system in the presence of an electromagnetic field can cause degradation of the ultrasound image If this occurs often Vitacon Bladder Monitor suggests a review of the system environment Identify and remove the possible sources of the emissions or move your system Medical Electric Equipment can be affected by portable or mobile RF communication devices Turn OFF any portable or mobile RF device before operating your system Electrostatic discharge ESD or static shock is a naturally occurring phenomenon ESD is common in conditions of low humidity which can be caused by heating or air conditioning Static shock is a discharge of electrical energy from a charged body to a lesser or non charged body The degree of discharge can be significant enough to cause damage to a transducer or an ultrasound system The following precautions can help reduce ESD anti static spray on carpets anti static spray on linoleum and anti static mats Do not use the system if an error message appears on the display note the error code call Vitacon or your local representative turn off the system User and Service Manual Page 8 VitaScan LT VITA CON Equipment Safety To protect your ultrasound system scanner and accessorie
30. rized by Vitacon will repair or replace products which prove to be defective during the warranty period This warranty does not cover equipment sold as used This warranty does not apply if the product has been damaged by misuse or as the result or service or modification by anyone other than a service center authorized by Vitacon The instrument shall be used in accordance with the instructions contained in this manual Consumable items shall be used in conformance with VitaScan product specifications Consumable items are not covered under this warranty Warranty conditions may differ in some countries Contact your local distributor for warranty terms Warranty extensions are available For more information please talk to your local Vitacon representative or contact Vitacon using the contact information give in the manual Disclaimer of Additional Warranties There are no understandings agreements representations of warranties expressed or implied including warranties of merchantability or fitness for a particular purpose other than those set forth in the preceding warranty section The contents of this manual do not constitute a warranty Some states disallow certain limitations on applied warranties The purchaser user and patient should consult state law if there is a question regarding this disclaimer The information descriptions recommendations and safety notations in this manual are based upon Vitacon experience and judgm
31. s follows these precautions Caution Use a Medical Isolation Device to power the Laptop To avoid the risk of excessive heating or damage to the system use the system in a well ventilated environment Ifthe operating environmental temperature exceeds 25 C limit scans to 5 minutes and allow a 10 minute cooling period between scans Excessive bending or twisting of cables can cause a failure or intermittent operation Do not submerge the VitaScan LT in any solution follow the cleaning instructions To avoid damaging the power supply verify the power supply input is within the correct voltage range Do not short the battery terminals Always charge the Laptop battery before using the system to avoid the risk of the system turning off while in use Incorrect cleaning or disinfecting of any part of the system can cause permanent damage Do not use solvents such as thinner or benzene or abrasive cleaners on any part of the system Do not spill liquid on the system Do not use the system if it exhibits erratic or inconsistent behaviour Turn Off the power of the system and call Customer Service Representative Do not dispose of the battery in fire Immediately discontinue use of the battery if while using charging or storing the battery the battery emits an unusual smell feels hot changes colour or shape or appears abnormal in any other way Contact customer service representative if any of these
32. sed hospital disinfection solution Use appropriate hand protection to avoid skin reactions with the glutaraldehyde Wipe the instrument with the dampened cloth To remove all traces of disinfection solution wipe the VitaScan LT with a clean soft cloth dampened in sterile water or cleaning solution Carefully dry the VitaScan LT with a clean soft cloth before use A Warning Do not subject any part of the VitaScan LT to steam sterilization or ethylene oxide sterilization Do not immerse the instrument in any cleaning or disinfecting solution Do not use CidexPlus to disinfect the instrument CidexPlus may damage the plastic enclosure User and Service Manual Page 13 VitaScan LT VITA CON VitaScan LT Application Software Installation Before use on patient Read the User Manual which is on the USB Memory stick and follow user instruction for the scan procedure System Requirements Windows XP Windows Vista Windows 7 Operating System 32 or 64 bit The minimum recommended system configuration is 1GB RAM amp 1 3 GHz processor speed VitaScan LT USB Probe Firmware version 2 7 or higher Laptop Computer type Dell XPS M1530 Model 9928L or equivalent USB 2 0 port to source 500mA 5V Medical Isolation Device e g Tripp Lite IS150HG N A or Noratel IMEDe 150 Int l ee Note Installing VitaScan LT Application Software on Windows 7 Operating System requires operator logged in as Administrator an
33. sful installation a VitaScan LT icon will appear on your desktop USB driver Installation First time VitaScan LT installation requires installation of USB driver for the VitaScan LT Run SETUP EXE located on the USB Memory stick in folder Driver setup exe Press Next Note the version indicated in the window is the installer version not the USBIO version Welcome to the Usblo Driver Installer v1 4 0 0 Setup Wizard This wizard will guide you through the installation of UsbIo Driver Installer v 1 4 0 0 Itis recommended that you dose all other applications before starting Setup This will make it possible to update relevant system files without having to reboot your computer Click Next to continue User and Service Manual Page 17 VitaScan LT VITA CON Press Install Choose Install Location Choose the folder in which to install Usblo Driver Installer v1 4 0 0 Setup will install Usblo Driver Installer v 1 4 0 0 in the following folder To install in a different folder dick Browse and select another folder Click Install to start the installation qram Files Thesycon UsbIo Space required 406 0KB Space available 155 9GB Press Next Installation Complete Setup was completed successfully Output folder C Program Files Thesycon Usblo Copy to C Program Files Thesycon Usblo UsbIo_ 64 inf Copy to C Program Files Thesycon Usblo Usblo_x64 sys Preinstalling device drivers This may
34. take some time to complete Please wait einstallation was successful Click Next to continue Cancel User and Service Manual Page 18 VitaScan LT VITA CON Finish the installation by pressing Finish Completing the Usblo Driver Installer v1 4 0 0 Setup Wizard Please disconnect and reconnect the devices you want to install and tum them on Connect the VitaScan LT probe to the computer to start the driver Note if the PC has more than one USB port please connect the probe to each different USB port while you are logged in as an Administrator The USB driver will be automatically installed and the probe well recognized on whatever port it could be connected The driver installation will not occur automatically if you are not logged in as an Administrator The USB driver installation takes some time please wait for Windows to display a successful installation message for each USB port User and Service Manual Page 19 VitaScan LT VITA CON User Guide This section illustrates different features of the VitaScan LT PC Software application and guides the user through the application This application interacts with VitaScan LT Probe Vitascan LT for data acquisition The Application displays real time images to the user to locate bladder Once the scan is completed the user can save the scanned images with patient information Ultrasound Bladder Monitor Application Software is developed to work o
35. tas 12 care Cleaning and DIS WATS CU NG eerie E dou aare anes 13 VitaScan LT Application Software Installation cccccccsssccccsssecccesseccceesececeeeseceeeueceeeeneceeseusecetseneess 14 SYSTEM Requirements cccscccseecseccetcosecouscesscessceusceseceseceseceseceseceseceseetaeetseetaeetaeetaeetseeseeeseesseeees 14 Installation of the VitaScan LT application cccecccccsssecccesececeesecceeeesececeeseceseeuecceseusecessuaeceesenes 14 RSE IS DS aU UO Ul a r hetero A A EEEE EE E eee aaa A E eg O iets 17 SM accessor sce a oat ee pov oe wos E asa ayers es ge va A A sgh ease Su ease Segre dateeysnsaeeeecaaens 20 PC Software Application Key FEQUUIES srsiicsacisacncsndnccusunnnacusiadsaosdunonadeis vonedusinnaavacteboiiuerensincceeraatcoes 20 y Ne 9 67248 9 91h E s 1 8 0 gt eee ene er ne ee eC ne eee eee 20 Run Via ers aim elles 8 e bd 9 p eee senate etree renee te Rien crn ae ore eee ne ee ne eee 21 Scanning on Vitacon PHANTOM asdescsrccccscssceunvseincudssaececessarceceesaenseevacnntuntucedesninwedessdessenioeresentonecnanis 24 Oer SCIE e E assess 25 Application Troubleshooting siiccsssvidesseanccudsaenteeraiedeasecewedysnuswesesnseyoursacdsdancnedsadatbeuxeuatssveeneeaeieeceess 26 Warranty and Disclaimer INFOrMatiOn cccccsscccccsseccccensccccssececeesececeescceseusececsuneceseuneceeseusecetsensess 27 S ELAT o E EEE N A E EEE OEE A EETA E O E T 28 User and Service Manual Page 3 VitaScan LT VITA
36. tion start Application log file and Scan folder images are not getting generated in Windows Vista OS gt The log in user should have access rights to the application folders or should have administrator rights to the folders Scanbutton is deactivated gt Press Clear Restart button or reset the VitaScan LT by removing USB connection for a few seconds and insert again gt Turn off Power Saving Mode Set Power Plan of the computer to High Performance Incorrect detection of bladder Insufficient battery capacity connect to external safe power supply Turn OFF Power Saving Mode Set Power Plan to High Performance Turn OFF Wireless network connection on your computer settings Turn OFF Bluetooth connection on your computer settings Stop antivirus program on your computer settings if applicable VVVV V ReScan please gt Incorrect detection of bladder Apply more gel on the Scanhead abdomen and angle the Scanhead below the pubic bone Verify that the bladder is placed over the center of the Bladder User and Service Manual Page 26 VitaScan LT VITA CON Warranty and Disclaimer Information Warranty Vitacon warrants the VitaScan LT against defects in material and workmanship of one 1 year from the date of purchase from Vitacon This warranty is given only to the original purchaser of the VitaScan LT instrument Pursuant to this warranty a service center autho
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