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OTI Scan 3000 User Manual

1. 4 TIME DEPTH The values shown generally give the best results As the sliders are moved the red curve displays the effects of the changes Time Gain Compensation TGC corrects the image for the natural attenuation of ultrasound in tissue Less sound reaches deep tissues and the echoes are correspondingly weaker This is seen on the screen as a fainter echo even when the tissue has in fact the same reflectivity as one nearer the probe The TGC system compensates by applying more gain to late echoes than early ones ideally it matches the extra attenuation exactly The gain levels for the anterior and posterior sections of the scan are set by adjusting the zone boundaries and the gain in each zone for the best view of each tissue The initial and final gain values are set with Low Gain amp High Gain the position and width of the transition between them are set using Transition Begin amp Transition End The settings will be memorized The sketch shows a typical TGC curve with the sliders linked to the corresponding parts of the curve 59 UMN 000002 Rev 2 du I OOO IOLs and Formulas Implant Details X polen IOL Implant IOL Formula B amp LChauvin Opsia Manufacturer EUROCRYSTAL gt B amp LiChirondolaba c HOLLADAY gt B amp LiDomilens 350 gt B amp L Storz SRK T gt Baus
2. 3 Focal Length 13mm 4 Operating mode Pulsed 5 PRF 3072Hz 6 Active diameter 7mm 7 Active surface 154mm 8 Axial resolution 0 0219 or 0 0153mm 9 Scan depth 15mm 10 UMN 000002 Rev 2 I OOO Acquisition i Vertic ii iii f Accuracy al resolution 1020 points Horizontal resolution 256 lines Linear resolution up to 14 6um Measurement accuracy depends on the probe frequency and the technique employed Maximum accuracy equals the axial resolution assuming no errors in technique IOL powers are displayed in increments of 25D with refractive errors estimated to 01D For SRK Il a 2mm error in axial length yields a 5D error in calculated refraction for other formulas a 5D error corresponds to a 15 error in the axial length UMN 000002 Rev 2 11 du I OOO 5 ALARA Section and Emissions Probe Material PZT Nominal Center Frequency 13 MHz Pulse repetition frequency Hz Type A scan Energy emitted in bursts Measurement must be repeated for new burst Ultrasonic Intensities in tissue Ispra 0 0285mW cm Isppa 6 76W cm Mechanical Index 0 13 Ultrasonic power 2 75uW At measured transducer focus 0 5 centimeters from probe tip The energy will always be attenuated by the tissue between the transducer and the focus when used as recommended The values presented here are the values at the focal point the point of maximum intensity
3. 1 336116 032R 4L L 0 00LIOLam L 16 032R 4A Ac x R 91 UMN 000002 Rev 2 9 HOFFER Q VARIABLES P Implant POWER D R Refractive error at corneal plane D Rx Desired ametropia Refractive error at spectacle D K Average Keratometry D CD Corrected Chamber Depth mm ACD Anterior chamber depth from the personalized IOL User file AL Axial Length mm CORRECTED CHAMBER DEPTH If AL lt 23 M 1 and G 28 If AL gt 23 M 1 and G 23 5 If AL gt 31 AL 31 If AL lt 18 5 AL 18 5 CD ACD 0 3 AL 23 5 tan 0 1M 23 5 x tan 0 1 G AL 0 99166 EMMETROPIA POWER R Rx 1 0 012Rx 1336 AL CD 0 05 1 336 1 336 R CD 0 05 1000 FORMULA GIVING THE REFRACTION RX VERSUS THE DESIRED IMPLANT IOLAM vs lOLam 1 336 E 1 336 CD 0 05 1336 AL 0 05 IOLam 1000 R Rx R 1 0 012R 92 UMN 000002 Rev 2 du I OOO SPECIAL CONSIDERATIONS FOR UNUSUAL CASES by H John Shammas M D Clinical Professor of Ophthalmology U S C School of Medicine Los Angeles CA Concurrent Astigmatic Keratectomy Subtract 0 25D from the pre op Ks for every diopter of the astigmatism to be corrected After Refractive Keratectomy Refractive History Method Subtract the change at the corneal plane induced by the refractive surgery from the average corneal powe
4. 03006 B Snap 141 MB Jun 10 21 Retinal Tear Vitreous Hem 03007 47 Collar button Choroidal 03009 B 50 Current Patient Choroidal Melanoma 03011 B 16 MB Cone button New CHOR MET 03016 35 MB BILAT RB 03020 B 81 MB Dislocated lens 03025 B snap 15 MB 5 Delete PVD Case 03026 B Snap 16 MB AScan Rectus Muscle Insertion 0001 HF Snap 41 MB Intraocular Commodative Lens 0004 HF Snap 75 MB Intraocular Lens HF 005 HF Snap 29MB Clipboard Clear Ciliary Body Tumor HF0013 HF Snap 66 MB IRIS Cysts HF0036 HF Snap 60 MB Pigment dispersion Syndrome HF0041 HF Before after Snap 56 MB 140 GB free is is a collar button shaped choroidal Last Name collar butto RF with solid low to medium internal reflectivity and requla First N r internal structure qst Name choroidal Melanoma Pathology le Sex Male C Female Birthdate un 07 2005 Update Shutdown screen open the different file management dialogs To view the patient s files click on the File tab or on Open Patient information and the case notes can be updated at any time by typing the new data in the appropriate field and clicking Update 71 UMN 000002 Rev 2 000 Click New to open the dialog for creating a new patient folder The first three lines are required information A Patient ID is automatically generated when the dialog is opened
5. Clipboard gt on Description General Controls Print Display F1 Save Generate Report F2 Copy to Clipboard F3 Snapshot F4 Change Velocity High Myopia Edit Shutdown tos record scan click on Live and placing the probe the eye Gain can be adjusted by turning the knob on the console or moving the Gain cursor with the mouse or footswitch The scan data is recorded in memory in a continuous loop 10 seconds long The moving cursor on the frame bar shows which frame is being recorded To freeze press the left footswitch or click the mouse The recording can be played back using the controls below the Frame bar Particular frames are selected using the Left and Right buttons or dragging the cursor along the bar To make a measurement click on each calliper and drag it to the required location The Description and General Controls are the same as in other modes Print sends the displayed curve to the printer Generate creates a report and Save stores the data in the patient s folder 61 UMN 000002 Rev 2 I OOO Change Velocity Change Velocity To ensure accurate length measurements the tissue velocity must be set to an appropriate value for the eye being examined Where there has been a m 2 vitrectomy with silicone oil replacement or the measurement range includes other structures where the velocit
6. du I OOO Selecting storage locations Several functions offer the choice of selecting or changing the location where a file will be stored They will all open the same Windows dialog boxes which are used to scroll through the file system open folders and create new folders M Folders are marked by a folder icon data files Save in 2 Desktop ce usually marked with the icon of the program that Documents created them 3 Computer Network Places Ultrasound Click Save to save the file in the location listed in the Shortcut to pc ubm Save In box Dave as type Files Cancel File name The Export Folders tab holds dialogs for changing the patient data folder and the file types used to export data Patients Files Reports Biometry Diagnostic Ascan B Scan UBM Utilities User Preferences Archive Export Folder Default image export type Current Folder Patient Log Lo Default movie export type Your current database folder is Version Information Default report export type C Documents and Catinns TTE ra stam IteazniineiE hri Change 64 UMN 000002 Rev 2 du I OOO User Preferences Version Information Archive ExportFolder GUI Yersiors Patient Log Version Information DLL version Build Date 4 Scan Console Serial Murmber Patients Files Reports Biometry Diagnostic
7. The OTI Scan 3000 software runs on Windows and uses the features of the Windows interface to direct the operation of the system and maintain patient records permitting a user friendly environment for clinical applications 2 System Components Depending on the configuration of the system the OTI Scan 3000 system consists of the B Scan ultrasound unit which contains the UBM B Scan ultrasonic pulsar receiver and scan converter and or an A Scan ultrasound unit which contains the A Scan ultrasonic pulsar receiver and scan converter The system may include a focussed B scan probe operating at 10MHz focussed biometry probe operating at 13 MHz diagnostic A scan and or focussed 35 or 50MHz high frequency UBM probes 3 Application To make a measurement the operator first displays the acquisition screen and follows the instructions for its various controls The probe is applied to the patient s eye directly or using an immersion cup For biometry there are two modes of operation automatic and manual In automatic mode the system identifies the critical structures in the eye and makes the measurements In manual operation the operator must freeze an image and then select the points for the measurements There are optional settings for particular cases such as dense cataracts or silicone filled eyes 7 UMN 000002 Rev 2 I OOO Specifications Dimensions b Power Supply C a Console 1 195 mm I x 116 mm d x 44 mm
8. ACD 3 3357 n1 1 336 n2 0 3333 LO AL Rethick 0 97971 x AL 0 65696 1 LO ACDE S2 1 Kd n2 x ACDE 3 n1 x Kd n2 LO S4 12x83 LOxKd 55 12 52 ACDE xKd 1336x 3 IOLxS1x 2 1 336 S4 0 001JOLx 51 55 1336 83 0 001 REFt x 54 REF X 1 33684 0001 REFt x 55 IOL FOR TGT UMN 000002 Rev 2 88 du I OOO S R K 1l EMMETROPIC POWER P A 2 5AL 0 9K C C Correction to the first S R K formula where C20 If AL lt 20 then If 20 lt AL lt 21 then If 21 lt AL lt 22 then If 22 lt AL lt 24 5 then If AL gt 24 5 then 11 AMETROPIC POWERS with P Emmetropic power Desired implant power Rt Target Refraction Rf Refraction factor Refraction Vs 1 Rt P I Rf where Rf 1 25 Rf 1 Implant Vs Rt P RtxRf where Rf 1 25 Rf 1 89 C 3 C 2 C 1 C 0 0 5 if P gt 14 if P x14 if P 14 if P x 14 UMN 000002 Rev 2 9 BINKHORST II VARIABLES LB AXIAL LENGTH CORRECTED FOR BINKHORST Lb LA 0 1984 mm ACD B ANTERIOR CHAMBER CORRECTED FOR POSTERIOR CHAMBER LENSES If Lb lt 26 then ACD b ACD x LA 23 45 If Lb gt 26 then ACD b ACD x 26 23 45 or ACD b 1 1087 x ACD R Cornea curvature in mm 337 5 K K in Diopters Ref Target Refraction Lb Corrected Axial length AC POST OPERATIVE ANTERIOR CHAMBER AC ACD for Anterior Chamber IOLs AC ACD b for Posterior C
9. B Scan UBM Utilities User Preferences Archive 1 27 f a 2005194120 65022 The Version Info tab gives the current software version and provides the serial number of the console Patient Log For Patient Lag Patient Log 050607 log Export Folder Patient Log 10 27 25 Retinal Tear Vitreous Hem Version Information 10 44 24 Retinal Tear Vitreous Hem Je to file 11 13 19 Retinal Tear Vitreous Hem e to file 11 13 20 Retinal Tear Vitreous Hem e to file 11 13 21 Retinal Tear Vitreous Hem e to file 11 13 45 Retinal Tear Vitreous Hem e to file 11 13 46 Retinal Tear Vitreous Hem ta file 11 13 28 Retinal Tear Vitreous Hem e to file 11 35 30 Retinal Tear Vitreous Hem 65 03007 created report 03007 added snapshot tiff 03007 added snapshot tifEt 03007 added snapshot tiff 03007 added snapshot tiff 03007 added snapshot 1 03007 added snapshot tiff 03007 added snapshot tiftf 03007 created report imag imag imag imag imag imag imag Print The Patient Log lists the examinations performed each day for the last week If required the list be printed UMN 000002 Rev 2 9 Chapter 4 Reports Patients Files Reports Biometry Diagnostic Ascan B Scan UBM Utilities Edit Size Stade Fonts Alignment Description Scan Report is can Report Patient Hame Retinal Tear Vitreous Hem Patient ID 03007
10. Date 21 2003 Description DEMO Jun 10 27 Current Patient Retinal Tear Witren ro BScan Print Preview Print Insert from Clipboard Insert All Ophthalmic Technologies Inc Shutdown When the user clicks Generate Report in any mode a properly formatted report will be created and the Report module will be opened to edit and print it The basic report is automatically saved to the patient s folder Text can be added at any point in the document by clicking and typing existing text is changed by selecting it and typing the new text Clicking Save will save the changes to the file New creates a blank generic report Delete erases the current report Export saves the report as a PDF file in the export folder See Page 68 and Print sends it to the printer The basic editing functions are shown on the next page The Insert buttons insert the selected image or the entire contents of the clipboard into the current report Three sample reports are included at the end of the section In the B scan report a second image was copied from the Clipboard 66 UMN 000002 Rev 2 N Edit Size Style Undo addition Redo Copy Paste Select All Clear Arial Black Comic Sans MS Courier New Default Dialog DialegInput Estrangelo Edessa Franklin Gothic Medium Gautam Georgia Impact Kartika Latha Lucida Bright
11. Machines MUST BE TURNED OFF before disconnecting probes Warning Avoid splashing liquids onto probe connectors end of the cable which is connected to the machine UMN 000002 Rev 2 I OOO PREPARATION OF DECONTAMINATION AGENTS mm DECONTAMINATION PREDISINFECTION AGENTS Proteolytic enzyme based agents 2 possibilities 1 0 5 ALKAZYME solution in water 20g packet Prepare according to manufacturers instructions The Alkazyme solution can be used for 8 days if kept in a sealed flask The solution can also be made up in a 4 L recipient using distilled water and fill up the soaking tray from there OR 2 0 596 ANIOZYME solution in water 25g packet Prepare according to manufacturers instructions The Aniozyme solution lasts 1 day in a sealed flask B DISINFECTION AGENT 1 596 ALKACIDE solution in water Prepare according to manufacturers instructions The Alkacide solution will keep for 8 days in a sealed flask Fill soaking tray 500ml when disinfection is necessary Wait 10 minutes after the last RENEWING CONTENTS OF SOAKING TRAYS For frequent use the contents of the trays should be replaced at the beginning of the C morning and at the beginning of the afternoon decontamination before emptying out the Alkazyme or Aniozyme solutions UMN 000002 Rev 2 30 1 2 3 4 I OOO Standard Protocol Immerse the probe and the cable except for the connector in a solut
12. It is not possible to vary the output energy of the transducer However to minimize exposure measurements should be kept as short as possible If more accuracy is desired the intensity the body at any transducer point may be calculated according to the formula recommended by the FDA lyexp 0 069fz where is the estimated in situ intensity Iw is the measured intensity in water at the focus of the transducer indicated in the above chart f is the ultrasonic frequency in megahertz and z is the distance from the face of the probe to the transducer focus in centimeters which is the point of measurement For this device f 12 and z 500 This formula was also used to calculate the derated values shown above 12 UMN 000002 Rev 2 du I OOO Transducer parameters show considerable variation from transducer to transducer The measured and calculated values shown above were those for an actual transducer whose values deviated slightly from the values in the specification given and whose values are likely to be different from the transducer with your system However the values in the specification should give results that are accurate enough for any practical purpose since the intensities are very low One should always minimize exposure by limiting the ultrasonic transmission to as short periods as possible Velocity of sound used by system values for different eyes Silicone Oil 907 13 UMN 000002
13. PARTICULARLY CREUTZFELD JACOB DISEASE WHEN USING OPHTHALMIC ULTRASOUND PROBES PREAMBLE The standard protocol must be used to ensure satisfactory decontamination predisinfection and disinfection of the probe after use The risky patient protocol must be used to ensure satisfactory decontamination predisinfection and disinfection of the probe after use on a patient where there is a risk of transmission of Creutzfeld Jacob disease OPERATOR S CLOTHING Single use overall Disposable gloves sterile for disinfection Glasses and anti projection masks EQUIPMENT Soft silk brush surgical nail brush 3x 500 ml stainless steel or plastic autoclavable soaking trays Single use hand cloths e g Kimwipes 9 Demineralized or distilled water PRODUCTS Cleaning pre disinfectant Aniosyme 9 P L A Company ANIOS or pre disinfectant Alkazyme alcalin Company ALKAPHARM The products must be diluted at 0 596 with warm water 25 C 30 C from the tap or distilled water The contents of the tray must be changed every day Disinfectant type Alkacide Company ALKAPHARM The product must be diluted at 596 with distilled water The solution must be changed every day 6Chlorometric degree solution of sodium hypochloride at 20 C The contents of the tray must be changed after each use Demineralized or distilled water REMINDERS Disconnect the probes from the machines
14. Rev 2 we A P 14 N robe Table 5 3 Acoustic Output Reporting Table for Track 1 Non Auto scanning Mode Transducer Model 2020 1368 Operating Mode A Mode Application s Ophthalmic Ispra3 Isppa3 W cm Acoustic Output 0 0285 Z5 cm Beam pum om pom c pow wm w 8 6 amp S Associated Acoustic Parameters ew D Ep T Operating Control Conditions UMN 000002 Rev 2 du I OOO 10 MHz Transducer Acoustic Output Reporting Table for Track 1 Autoscanning Mode Transducer Model 10MHz S N 208027 Operating B Moade Mode Application Ophthalmic Acoustic 5 Qutput mW iem Miem 5 ce c ra Global Maximum Value MPa 0 482 Associated Acoustic Parameter dimensions 3840 Operating Contro e 384 lines per scan Conditions a 15 UMN 000002 Rev 2 du I OOO 20 MHz Transducer Acoustic Output Reporting Table for Track 1 Autoscanning Mode Transducer Model 20 MHz B Mode Operating B Mode S N 22600 Mode Application Ophthalmic Acoustic 5 5 Output mV icm Wem Global Maximum Value MPa 0 517 Assaciated Acoustic 14 0 Parameter 17 Beam
15. and all the corresponding Files Clicking Delete will delete the selected patient 77 UMN 000002 Rev 2 I OOO 1 Files When a Patient folder is opened a list of the files saved for that patient is displayed Patients Files Reports Biometry Diagnostic Ascan B Scan UBM Utilities Description B Scan Capture File T 12 Snapshot Jul 16 2003 10 23 T 6 Snapshot Jul 16 2003 L 3 Snapshot Jul 16 2003 Current Patient B Scan Capture i Jul 15 2003 Diabetic Tractional DEMO B Scan Capture File Jul 16 2003 B Scan Capture File Jul 16 2003 ri B Scan Capture File Jul 15 2003 real Delete l AScan BScan PY y r Clipboard Shutdown View Copy To Clipboard F3 When an image file has been selected in a Patient Folder a preview window opens with basic information and controls The image can be reviewed to ensure the correct file is selected See Page 81 for more information on the Snapshot controls 78 UMN 000002 Rev 2 M I OOO The controls beside the list will open export preview or delete the selected file When the clipboard is view enabled Copy to Clipboard will copy the current frame Export Confirm x Copy To Clipboard F3 69 Are you sure you want to delete this File to the clipboard for use in a report Selecting Delete will open the confirmatio
16. clicking on a scan will switch to selected table entry view with the selected scan displayed that window EO teas ae n 1 J a 4 UMN 000002 Rev 2 27 I OOO 9 Once a sufficient number of good scans have been acquired the patient data must be entered If the axial length is already known it can be entered directly K1 K2 42 87 43 21 Target Aiaia AXL is the axial length of the best scan or the average of the acquired scans 0 0 10 Select the correct IOL and formula for the patient IOL IOL Implant 09 PHARMACIABOSC AlconAcrysof HOFFER Q c oe ae AMODLS2 HOFFER Q AMODLS2 HOLLADAY AMAACG1 Clicking the Edit button opens the Implants amp Formulas window where IOL constants and formula IOL combinations are set up See Page 59 11 Click on Generate Report to create and open the report for editing see page 65 This button will not be active until all required information is entered If both eyes have been scanned data must be entered for both even if a calculation is only required for the second eye 58 UMN 000002 Rev 2 x 5 Edit TGC This button opens the TGC editor Edit Low Gain High Gain 270 Transition Begin 411 48 i Transition End mm Sa a 45 40
17. dimensions useci Hz 3840 Az cm Ele cm 50 degree scan angle Operating 10 Hz scan rate Contro 384 lines per scan 16 UMN 000002 Rev 2 I OOO 35 MHz Transducer Acoustic Output Reporting Table for Track 1 Autoscanning Mode 35 MHz B Mode SN 35 00894 Ophthalmic Transducer Model Application Acoustic Output Global Maximum Value Wa Associated Acoustic Parameter Seam dimensions Y 5 cm 18 degree scan angle Operating Control Conditions 17 om S Hz scan rate 384 lines per scan Operating B Mode Mode IsPTA3 ISPPA3 Wom mV cn m Dn JR E e ca 5 19 4 1 00 0 0350 UMN 000002 Rev 2 mm m z I OOO 50 MHz Transducer Acoustic Output Reporting Table for Track 1 Autoscanning Mode Operating B Mode B Mode IsPPA3 Transducer Model Penpheral lsPTA3 Miem rnW cm Application Acoustic Qutput Global Maximum Value Associated Acoustic Parameter Seam YE dimensions PD sec 0 0410 Operating Control Conditions UMN 000002 Rev 2 18 N STANDARD SYMBOLS Attention consult accompanying documents Dangerous voltage Symbol type B equipment Accessible conductive parts are connected to earth Classe 1 9 Equipotential point UMN 000002 Rev 2 19 I O00 DESC
18. function is not available the corresponding control is greyed out and doesn t respond This panel in the upper right corner of each screen shows the current patient the date and time and the current assignment of the footswitch pedals In this case pressing the left pedal saves the current Jun 10 26 Current Patient scan and pressing the right pedal will start a new Retinal Tear Vitreo scan E clicking on them will have the same effect as pressing the pedal does l Save Live ow CHE 1 m E r LP 33 UMN 000002 Rev 2 The General Controls panel contains functions that are to multiple scanning and viewing modules General Controls 4 Print Screen sends the current scan to the printer providing quick output where a full report is not desired Print Display F1 Generate Report copies the current view to the Report module where observations comments and diagnostic evaluation can be added Generate Report F2 n Additional images can be inserted from the clipboard when is enabled Copy to Clipboard F3 Copy to Clipboard and Snapshot options are available The measurement mode and scan mode lists will offer the options that snapshot F4 are available in the current scanning module Vector 15508 1550 mis Zoom zooms the image 4x Color Display generates a false colour image Retina zoom Col
19. h 2 Weight 0 6 kg Console 1 Medical Grade Power Supply Input Voltage range 100 240V AC 2 3 Output Voltage 12V DC 4 Frequency 50 60Hz 5 AC power consumption 18VA 0 120V 6 DC power consumption 13W Operating conditions 1 Operating 19 degrees to 35 degrees C 32 to 95 F i Temperature 2 Storage 40 to 65 C 40 to 149 F ii Relative humidity 1 Operating 10 to 90 non condensing 2 Storage 5 to 95 non condensing UMN 000002 Rev 2 d Probes I OOO i Biometry 1 Reference US PRO A 2 Frequency 13MHz 3 Focal Length 23mm 4 Operating mode Pulsed 5 PRF 10Hz 6 Active diameter 3 5mm 7 Active surface 9 6mm2 8 Axial resolution 0 12mm 9 Minimum distance measured 12mm 10 Maximum distance measured 37mm 11 Acquisition i Horizontal resolution 1020 points ii Vertical resolution 256 points Linear resolution 0 052mm B Scan 1 Reference US PRO 10 2 Frequency 10MHz 3 Focal Length 23mm 4 Operating mode Pulsed 5 PRF 3840 Hz UMN 000002 Rev 2 I OOO 6 Active diameter 7mm 7 Active surface 154mm2 8 Axial resolution 0 15 Hi Res B Scan 1 Reference US PRO 20 lii 2 Frequency 20MHz 3 Focal Length mm 4 Operating mode Pulsed 5 PRF 3840Hz 6 Active diameter 7mm 7 Active surface 154mm2 8 Axial resolution 0 09mm iv High Frequency 1 Reference US PRO 35 US PRO 50 2 Frequency 35 or
20. it should be replaced with the ID normally used in the practice gt Please enter patient information E xj Please enter patient information Patient ID Last Name First Name Pathology Ref Physician Birthdate Refraction Pathology Ref Physician Sex Birthdate Refraction 57828 os Notes Male Female 00 dd J 05 OD Last Exam Add Patient Pathology Age related macular degeneration Angioid streaks Pathology can be entered Branch retinal artery occlusion directly in the field or a standard description selected from the drop down list Branch retinal vein occlusion Bullous retinal detachment Central retinal artery occlusion Central retinal vein occulusion Central serous chorioretinopathy UMN 000002 Rev 2 I OOO x Referring Physician The name of the referring physician can be selected from the drop down list New names must be added through the Add Physician dialog which is opened by clicking Add Edit opens the same dialog to edit the e mail entry MMM dd yyyy Ref Physician Sex Harold Cooper Birthdate 05 OD Refraction Add Physician The physician name and e mail address are entered Once entered the name cannot be edited The e mail address can be used to automatically e mail reports to the physician Add Physician Doctor
21. s Name Cancel OK Doctor s Email UMN 000002 Rev 2 73 m 2 F OOO Search for Patient The first characters of the Patient ID or last name are entered in the search field ID searches are case sensitive strings must be entered as they appear in the patient record Clicking Search will list the patients matching the search parameter in the Results box results can be sorted by clicking on the column headers Clicking on a patient then Select will open the patient entry If the patient isn t found clicking New will open the New Patient dialog so that a new entry can be created Search for Patient Search by Pathology Search by Last Exam Date Search By File Type Search Reports Search New Search by Patient ID Search by Patient Last Name Results ILIB2 0945 see To find patient s file click Search to open the Search dialog Enter the search parameter in the correct box and click Search to search the patient list It is possible to search for a particular patient for all patients with a particular pathology for patients seen in a particular range of dates for a particular type of saved file or for all patients with a given text saved in their exam results UMN 000002 Rev 2 74 I OOO Search By Pathology Search for Patient Search by Pathology Search by Last Exam Date Search By File Type Search Reports Search by Pathology x sear
22. select the correct value for the connected probe The probes must be used with an immersion cup DANGER CONTACT BETWEEN THE MOVING TRANSDUCER AND THE EYE CAN CAUSE SEVERE INJURY THE USER MUST TAKE EVERY PRECAUTION TO PREVENT THE TRANSDUCER TOUCHING THE EYE 42 UMN 000002 Rev 2 Ne 2 I OOO To start E a scan place the immersion cup on the eye and fill with sterile saline Click on to start the transducer moving Place the probe in the cup and move it towards the eye until the cornea appears at the bottom of the image Proceed with the examination The UBM module shows the image with a simultaneous A scan profile Start recording by clicking Live or pressing the right footswitch end by pressing the right footswitch or pressing Stop The recording can be played back using the controls below the Frame Counter bar 41 gt Particular frames are selected using the Left and Right buttons or dragging the cursor along the bar A specific section of the recording can be selected for playback by placing the green Start and red Stop markers inside the Frame bar These are the frames that will be saved to the patient s folder if this option is available Loop Play Half Speed Image Adjustment Cont Gain These sliders control the contrast and brightness of the image They are set by clicking and dragging them with the mouse or by pressing the knob on the cons
23. space unexpectedly if 2003 07 08 Image of DEMO 4 snap archiving is not kept up to Zo S07 SA Tmarre nf Demo zl 2 date user can select the 17 file s ready to be archived Total size is 1 10 MB period that files can be left unused before being marked for archiving Shutdown after archiving 20 The normal medium for archives is CD R but any external drive recognized by Windows may be used Optimize Database Files Refresh Drive List can be used to locate a drive that is not recognized automatically and add it to the list of Archive drives The user determines how long files may be left unused by selecting the period from the Archive files pick list If more than one drive is available for archiving a similar list can be opened beside Archive Drive The system can be left to complete the archive operation and shut itself off if the Shutdown box is checked Note the files to be archived must fit on one disk for the operation to complete When all the options are selected click on Archive to start the process 85 UMN 000002 Rev 2 du I OOO Chapter 6 Background Theory and Formulas 1 AXIAL LENGTH MEASUREMENTS Steps for Accurate Biometry IOL Power Calculations BIOMETRY AXIAL LENGTH MEASUREMENTS 86 Scan Capture Capture at least 6 10 measurements scans review each of the captured images Select only the scans with a good echo pattern and delete the rest At least 3
24. these values are averaged between different IOL manufacturers Small variations of IOL tissue velocity between different manufacturers will not effect the reading substantially If the user is not sure what kind of IOL was implanted an observation of the retinal echo distance may help C PL R Good scan markers placed at the peak of each echo Poor scan off axis scan AL echo too low retina echo too low front of the base line retinal marker off retina not perpendicular to to the right If either the AL or Retinal echo is too low it is an indication that the probe is off the visual axis The axial length may be either too short or too long Note The first marker Cornea will be to the right of the initial peak which is the front of the transducer The tip of the probe will be to the right of this 87 UMN 000002 Rev 2 N IOL Formulas VARIABLES USED Variables in any formula AL Axial length K Averaged dioptric power of the cornea K1 K2 2 R Corneal curvature in mm 337 5 K K in Dioptres ACD Post Operative Anterior Chamber Depth S R K T Retinal thickness Rethick 2 0 65696 0 02029 x AL Lc AL except if AL gt 24 2 Lc 3 446 1 716 x AL 0 0237 x AL 337 5 R 337 5 1 5 40948 0 58412 xLc 0 098 x Rc R C1 7 4 If lt O then 0 2 ACD 0 62467 x A 68 74709 where A SRK Constant ACDE C2
25. third party on its products including but not limited to operating system upgrades and device drivers When software not supplied by OPTOS interferes with the operation of the system the product will be returned to its original condition at the user s expense OPTOS may occasionally furnish to users software not directly related to the functioning of its products Such software is supplied as is without warranty of any kind and the availability of support for such software is at OPTOS sole discretion 3 UMN 000002 Rev 2 du I OOO Standards and Regulations e FDA Approved K092837 e This device is a Class lla medical device as defined by the European Medical Device Directive MDD e The device complies with the EC Medical Device Directive 93 42 EEC Warnings and Cautions Warning Switching cold instrument near 0 Celsius will permanently damage it Let the instrument reach a normal room temperature for half a day to allow the internal elements to warm up and to avoid any thermal shock hazards when switched on The cover will quickly reach room temperature but not the internal circuitry Warning Unit is approved for operation only with the included power supply Warning Disconnect AC POWER before cleaning the case Warning Data will be saved under the same patient name until another has been selected Warning The transducers are fragile Dropping or striking any probe can cause it
26. to malfunction handle all probes with care If a probe should be dropped inspect it carefully for chips and cracks and make a test scan on a known object Warning This device is not intended for foetal use Caution The console must not be disconnected from the computer while the system is running Caution The probe must be connected or disconnected only when the unit is switched OFF 4 UMN 000002 Rev 2 du I OOO Warning Never autoclave a transducer or expose it to high heat Caution Follow the instructions included in this manual for disinfecting the transducer after each use Caution Applying excessive pressure to the probe will cause discomfort for the patient and distort the eye resulting in incorrect measurements Caution Choosing the wrong vitreous material will create serious errors in the axial length and calculation result in Biometry mode 5 UMN 000002 Rev 2 9 Introduction This User s Manual describes the OTI Scan 3000 B and UBM system hardware and software This page is a brief outline of the entire system The functions described will not be available on every system the selection depends on the system configuration The software uses a tabbed interface the user can select any of the primary functional modules at any time by clicking on the tab for that function at the top of the screen When there are several major components in a function these are presented as tabs below the pri
27. 4 good scans with an Axial Length standard deviation 5 of 0 1 or lower should be saved and used for IOL calculations The variation of the axial length from the highest to the lowest of the scans should be not more than 0 1 0 2mm The software also indicates the anterior chamber depth standard deviation SD This information indicates to the user the degree of variation in the anterior chamber depth AC measurements Large variations in AC measurements indicate compression of the cornea and or off axis positioning of the probe Selecting the Best Scans review each scan verify the position of the 4 markers Each marker should be placed at the top of the echo Observe the Retinal echo it should be sharp 90 degree from the baseline with minimum amplitude height of 70 of the corneal echo The Anterior Lens and Posterior Lens echoes should also have a height of at least 7096 of the corneal echo Note in cases of dense cataract the posterior lens echo will be lower than the Anterior Lens echo due absorption of sound by the opaque lens Pay attention to the Anterior Chamber Depth ACD The operator should save the measurements with longest ACD These are usually the measurements where there was minimum corneal compression An off axis probe position may also produce a longer ACD however in this case the retinal echo will be of poor quality Dense Cataracts In a dense cataract additional low echoes might appear between th
28. Consumed During a Field Service Visit B A and UBM Ophthalmic Ultrasound User Manual U S Federal Law requires that this device be used only by or under the supervision of a physician optos 621 W 20 Street Hialeah FL 33010 Phone 508 787 1400 Toll Free 888 268 6756 UMN 000002 Rev 2 F OOO Regulatory Notices U S Federal Law requires that this device be used only by or under the supervision of a physician This device has been found to operate within the limits for a Class A digital device and is not intended for use in a residential environment This is a Class Ila medical device Electrical Safety Class Manufacturer Optos Hialeah 621 W 207 Street Hialeah FL 33010 USA Toll Free 888 268 6756 Direct Line 508 787 1400 International Fax 508 486 9310 Worldwide Corporate Office Optos Plc Queensferry House Carnegie Campus Enterprise Way Dunfermline Scotland UK KY11 8GR Tel 44 0 1383 843300 Fax 44 0 1383 843333 Optos North America Headquarters Optos North America 67 Forest Street Marlborough MA 01752 USA Call Toll free US amp Canada 1 800 854 3039 Outside of the US 1 508 787 1400 UMN 000002 Rev 2 du I OOO Warranty Information OPTOS warrants its products are free of defects of labor and material for two years for electronics 1 year for probes Associated computer systems carry a 1 year manufacturer s war
29. Description Image of DEMO Os Reset Snapshot Export Snapshot Wy TW Clicking on A B Cor D creates a pointer that 2000 can be positioned by clicking and dragging on a joe the arrowhead or letter E oe Print Snapshot Generate Report F2 Copy To Clipboard F3 UMN 000002 Rev 2 83 gt 2 I OOO Reset Snapshot OS Gain 82 dB Dyn 85 dB Export Snapshot Print Snapshot Generate Report F2 Copy To Clipboard F3 Reset Snapshot a Export Snapshot The Caliper functions in the MO same aS majaca the calipers in B scan a co This image was zoomed before Print Snapshot Generate Report 2 Copy To Clipboard F3 Description mage of DEMO 05 2 06 mim 84 UMN 000002 Rev 2 du I OOO 5 Archiving Data Archiving Data must be archived to ensure that it is not lost in the event of a system failure Archive files not touched for 2 Months Removin g nfreq ue ntly viewed files from the disk will also improve performance Archive Drive Insert blank CD before archiving D a Retresh Drive List BES and free space B mode movies can be very large and Se ra eee the user can run out of disk You can archive old files or an external hard drive Archivable Files HFOOOS 031031 150034 snap 2003 07 08 Image of ACCOM LIGHT snap 2003 09 08 Image of DEMO 3
30. IOL D REF D IOL D REF D 7 50 1 72 10 50 2 08 8 00 1 34 11 00 1 58 8 50 0 96 11 50 1 08 9 00 0 57 12 00 0 58 9 50 0 18 12 50 0 08 10 00 0 22 13 00 0 42 10 50 0 62 13 50 0 92 11 00 1 03 14 00 1 42 11 50 1 44 14 50 1 92 Comments 69 UMN 000002 Rev 2 S 5 OTI Scan Report Patient Date of Image Description Intraocular Lens Patient ID HF0005 Jun 7 2005 OS Axial Length 26 59 mm Average 27 11 StdDev 0 27 Target Ametropia 0 K1 43 2 0 K2 42 9 D Contact Phakic Vac 1532 00 VI 1641 00 Vv 1532 00 AP961L Allergan loptex IPP601350 EUROCRYSTAL Formula SRK T Formula SRK II 114 5 A 118 3 IOL D REF D IOL D REF D 7 50 1 72 10 50 2 08 8 00 1 34 11 00 1 58 8 50 0 96 11 50 1 08 9 00 0 57 12 00 0 58 9 50 0 18 12 50 0 08 10 00 0 22 13 00 0 42 10 50 0 62 13 50 0 92 11 00 1 03 14 00 1 42 11 50 1 44 14 50 1 92 Comments 70 UMN 000002 Rev 2 LIT 2 I OOO Chapter 5 Operation Advanced Functions 1 Patient Management The software will start showing the Patient List with functions for the management of patient files To select a patient click on the name to highlight it The buttons on the left side of the Patients Files Reports Biometry Diagnostic Ascan B Scan UBM Utilities Search Patient Name Patient ID Pathology Disk Used Vitreous Hemorrhage 03001 B 27 MB
31. Lucida Console Lucida Sans Lucida Sans Typewriter Lucida Sans Unicode Mangal Marlett Microsoft Sans Serif Monospaced My Boli Palatino Linotype Raavi SansSerif Serif Shruti Sylfaen Symbol Tahoma Clicking on any of the five tabs above the report window opens editing controls identical to those found in any basic text editor The user has complete control over the appearance of the report Style Fonts Bold Set font size Italic Underline Subscript Superscript Set the style of the text Set text alignment XL Alignment JustiFied Times New Roman Choose the font 3 d Lert Trebuchet 5 Tunga Verdana Vvrinda Webdings Wingdings 67 enter Right UMN 000002 Rev 2 Report Patient Name Retinal Tear Vitreous Hem Patient ID 03007 Date May 21 2003 Description DEMO Comments hemorrhage not clearly visible in all views 68 UMN 000002 Rev 2 F OOO OTI Scan Report Patient Name Intraocular Lens Patient ID HF0005 Date of Image Jun 7 2005 Description Lon amp 4 33 LU Z2 vit 21 94 70 59 NN Fg resa Hanen OS Axial Length 26 59 mm Average 27 11 StdDev 0 27 Target Ametropia 0 K1 43 2 0 K2 42 9 D Contact Phakic Vac 1532 00 VI 1641 00 Vv 1532 00 AP961L Allergan loptex IPP601350 EUROCRYSTAL Formula SRK T Formula SRK II A 114 5 A 118 3
32. RIPTION and CONNECTIONS A Front Panel A Scan B Rear Panel A Scan Power In 20 Multi function control OPHTHALMIC TECHNOLOGIES INC Toronto Canada 3E5 416 631 9123 USB port UMN 000002 Rev 2 I O00 Fan C Front Panel B Scan B or UBM Probe 1 97 I Thenon Bsa D Rear Panel B Scan Power In 21 1394 Firewire 1394 Firewire UMN 000002 Rev 2 E Probes and Accessories 10MHz amp 20MHz B Probe A Biometry Probe 22 UMN 000002 Rev 2 I O00 35 and 50 MHz UBM Probes The transducer is removable for storage and cleaning Do not store the probe with the transducer attached Power Supply MODEL M 10 zu Ps NGANG TP AUSGANG 1206 UMN 000002 Rev 2 23 B Probe Cable Probe Holder 24 UMN 000002 Rev 2 FOOO A Scan Footswitch 25 UMN 000002 Rev 2 I OOO mm Chapter 2 Set up and Maintenance 1 Setup A INSTALLATION a Place 5 and computer a flat surface Position the system to ensure that the operator will be comfortable during use b Before connecting consoles ensure that software is properly installed See 5 3000 Software Installation Instructions Connect power supply to OTl Scan and AC power Connect computer to instructions Connect Firewire ca
33. Results box results can be sorted by clicking on the column headers Clicking on a patient then Select will open the patient dd Patient Pathology First UMN 000002 Rev 2 m 2 I OOO Search by File Type Search by File Type finds all patients with particular files in their folders Clicking Search will list the patients matching the search parameter in the Results Box Results can be sorted by clicking on the column headers Clicking on a patient then Select will open the patient entry Search for Patient Search by Pathology Search by Last Exam Date Search By File Type Search Reports Search By File Type A Scan Capture File A Scan Biometry File Scan Biometry Movie UBM Capture File Movie B Scan Capture File Search Reports Any text string in a saved report can be entered in the search field Searches in this section are not case sensitive Clicking Search will list the patients matching the search parameter in the Results box results can be sorted by clicking on the column headers Clicking on a patient then Select will open the patient entry Search for Patient Search by Pathology Search by Last Exam Date Search By File Search Reports Search Case Insensitive Search Reports last Results UMN 000002 Rev 2 76 X if the user clicks Yes in the confirmation dialog e Are vou sure vou want bo delete this patient
34. aces and retina If the eye is unusually small or large the zones can be changed by dragging the ends to the left or right 55 UMN 000002 Rev 2 we I OOO 8 When the scans are acquired they must be reviewed to ensure that they are of good quality Clicking on the length in the Axial Length window selects the scan and displays it in the Axial Length Table Display window Axial Length 23 89 24 11 2302 23 76 23 91 23 31 23 85 Add Remove Use Average AVG 0 00 STDDEV 0 00 If Use Avg is checked the average length will be used in the calculation The average length and standard deviation are shown at the bottom of the panel Clicking on Remove will delete the scan Add includes the scan shown in the Recording View window If more scans are needed click on Live to start scanning and acquire more lt Recording view Selected table entry view gt The measurement on a scan shown in this window can be edited in the same way as in Recording View The entry in the Axial Length table is updated automatically 56 UMN 000002 Rev 2 I OOO x Recording view Selected table entry view gt L 48 Vit 17 95 AXL 27 52 Con Phakic When a cursor is being placed the scan 15 automatically zoomed to that part of the curve This allows accurate placement of the cursor on the scan AC 2 08 Miniature views of all the stored scans a displayed in a 3x3 Double table
35. ach segment Chord measure is a special biometry mode intended for certain types of ocular implant vector 1550 m z Vector 1550 This is the default measurement mode The cursor is the green and red line running through the image Clicking and dragging its upper end changes the horizontal position of the cursor Clicking and dragging the lower end changes the angle The profile is displayed in the window below the image linear measurements assuming an average tissue velocity of 1550m s are made by dragging the vertical gates to the proper points on the profile The red section of the Profile cursor covers the interval being measured M M AN M A U WAN Y AW Ww UMN 000002 Rev 2 46 I OOO Calipers Clicking on H W measure replaces the Profile cursor with a pair of linear cursors that allow linear measurements of the image using a tissue velocity of 1550m s The cursors are placed by clicking on each end and dragging it to the required point They will move independently and there is no fixed relation between them The profile window is frozen in this mode For this image Color Display has been checked creating a false color rendering of the image using a fixed color table Angle Measure To measure the angle between two surfaces such as the anterior chamber angle shown above check the Angle Measure box The apex of the angle and the end points of th
36. be properly capture good scans and verify proper positioning of the gates 50 Patients Files Reports Biometry Diagnostic B Scan Utilities Lo Biometry _2nd Eye Biometry 2D Dynamic Recording Live Next Good Gain EE LE 1 Scan Type Lens Type Contact Phakic immers Aphakic PMMA Vitreous Natural Acrylic Silicone 980 C Silicone C Silicone 1040 Dense Cataract Description Save 0S IOL IOL Formula IOL Implant Live Display Calibrate mE Axial Length 26 94 2 Jun 12 31 26 74 Current Patient un Mone Selected 25 58 25 38 Report Live 27 55 28 93 27 08 Add Use Average K2 D Axial Lenath Table Display Multi view General Controls Print Display F1 Copy to Clipboard F3 Snapshot F4 High Myopia Edit Shutdown UMN 000002 Rev 2 Sp 000 Calibration The system should be calibrated at regular intervals Click Lalibrate X 8 83 Calibration Successful 8 93 8 93 8 93 8 83 Average 8 83 8 93 8 93 Standard Dewation ans 0 00 8 83 883 Block Length 91 To calibrate the system place the probe the rear of the calibration block and click on Calibrate The system will measure the block ten times and compare the average leng
37. ble to 5 and computer e Connect all probes f Switch on the 5 then switch on the computer accordance with manufacturer s g Install and connect printer in VENTILATION Like other electronic equipment the OTl Scan 3000 produces heat which must be exhausted for correct system operation Keep the unit away from walls to allow air circulation and never cover the unit even partially with protective cover files etc during use It is particularly easy for laptop computers to overheat when used in confined spaces B In C The OTI Scan 3000 is designed to use standard printers the printer must be Windows PRINTERS compatible Print speed and quality will depend on the printer chosen An inkjet printer will provide better image quality laser printers are faster and more economical to operate general the printer is not supplied OPTOS can only offer limited assistance with the Printer Installation installation of printers All printers should be installed according to the directions in the user s manual supplied with selection of printers may be pre installed on the OTI Scan 3000 the printer using the correct Windows drivers Drivers and driver installers for a limited UMN 000002 Rev 2 26 I OOO Maintenance Clean the case with a damp cloth Use appropriate products to clean the computer mm Cleaning keyboard and monitor Cables may be cleaned with a soft cloth and alcohol T
38. ch Search by Pathology Age related macular degeneration Angioid streaks Branch retinal artery occlusion Branch retinal vein occlusion T JBullous retinal detachment Central retinal artery occlusion Central serous chorioretinopathy retinal vein occulusion Search by Last Exam Date Search by Last Exam Date Midiy dd Results Patient ID 79 Last Patient Pathology Search by Notes Results First Name SearchforPatient Search by Pathology Search by Last Exam Date Search By File Type Search Reports Patient Pathology Search for Patient Search by Pathology Search by Last Exam Date Search By File Type Search Reports entry Between 25 2007 E and 25 2007 E Search Midiy Last Exam in the Pathology Text field or Notes field can be searched by entering the string in the search appropriate box Pathologies can also be selected from the drop down list Clicking Search wil list the patients matching the search parameter in the Results box results can be sorted by clicking on the column headers Clicking on a patient then Select will open the patient entry Search by Last Exam Date finds patients last seen in a particular period by entering the start and end dates in either of the indicated formats Clicking Search will list the patients matching the search parameter in the
39. ch amp Lamb Type Post C Ant gt Corneal gt Dr Schmidt 18 3 EUROCRYSTAL Surgeon Factor 1 39 ACD 514 AD 453 AX Add Update Remove xl IL Implant IOL Formula APSBTL Allergandoptex SEK T PF01350 ELIROCRYSTAL SRE I 01 350 EUROCRYSTAL HOFFER 2 Readings in mm Diopter Interval for Reports 025 05 Add Remove 60 software includes a list of available 1015 with data provided by the manufacturers To select an IOL double click on the manufacturer s name to open a list of IOL models and highlight the selected lens To alter the default IOL selections or add one not in the list simply enter the manufacturer model type Anterior Posterior chamber the constants obtained from the manufacturer then click on Update for an existing lens or Add for a new lens Remove deletes a selected IOL from the list Specific combinations of formulas and IOLs are created by selecting each from the individual lists then clicking Add A combination is deleted by selecting it from the Implant Formula list then clicking Remove UMN 000002 Rev 2 E e I OOO 4 Diagnostic A Scan Click the Diagnostic A Scan tab to enter A Scan mode Patients Files Reports Biometry Diagnostic Ascan B Scan UBM Utilities Live Display 2D Dynamic Recording Jun 3 54 PM Current Patient AScan BScan
40. connectors are kept dry Rinse the probe and cable with de mineralized or distilled water Immerse the probe and the cable except for the connector in the ALKACIDE solution for 15 minutes Rinse the end of the probe with de mineralized or distilled water Keep the connectors dry Dry with a sterile compress or a single use dry wipe if the rinsing water was sterile Reminder The contents of the trays should be allowed to stand 10 minutes after disinfection is complete before replacement 32 UMN 000002 Rev 2 du I OOO Chapter 3 Operation Basic Functions The operation of the OTI Scan 3000 revolves around the computer and monitor All functions are controlled through the screen and the computer and all results are displayed on the monitor screen The system includes a holder and calibration block for the probes At the start of an examination the operator sees the Patient List which allows selection of examination mode or access to patient files The scan being taken appears on the acquisition screen The scan can be frozen or unfrozen on this screen by using the mouse or foot switch Buttons on the screen permit storage of the scan freezing printing and measurements Moving markers to various anatomical points makes measurements The distances between these markers are then indicated on the screen In biometry the measurement may also be taken automatically by choosing automatic freeze on the Acquisition screen When a
41. e sides are placed by clicking on them and dragging to the correct location The sides can be any convenient length but for the greatest accuracy they should be as long as possible With the lever effect of a long arm it is easier to make small changes in the included angle The measurement is displayed below the apex UMN 000002 Rev 2 9 Biometry The Biometry module is intended distance to provide accurate measurements in the anterior particularly along the segment optical axis The components are recognized automatically and the correct tissue velocities for each component are used 1641m s for the cornea and lens and 1532m s for the aqueous To make a measurement Vector mode to place the cursor on the axis then click on the measurement mode list and select Biometry The system will identify the anterior and posterior surfaces of the cornea and lens and display the gates on the curve The gates can be moved by clicking on them and dragging them to the desired use location Cornea 0 57 mm ACD 3 40 mm Lens 4 01 mm all i hun UMN 000002 Rev 2 47 48 I OOO Chord Measure Chord Measure determines the chord length from the center of the corneal face to the sclera at a level marking 1 3 of the thickness of the lens Making a measurement requires an image that clearly shows the cornea the anterior and posterior lens and the sclera Position the Prof
42. e Anterior Lens and the Posterior Lens echoes Some reverberations of the Anterior and or posterior Lens echoes might be present in the vitreous when the cataract is very dense especially when higher Gain is needed in order to capture the retinal echo Note make sure that the markers are positioned on the principal Anterior and Posterior lens echoes and not on the repetitions in order to avoid error in measurements In a very dense cataract the user may need to increase the gain setting in order to achieve good retinal echo This is due to the higher absorption of sound in the dense lens Silicone Oil filled eye In the case a of silicone oil filled eye the tissue velocity must be corrected UMN 000002 Rev 2 du I OOO If oil was placed in the vitreous and the posterior capsule is intact replace the Vitreous Tissue velocity 1532 m sec with 980 m s in the User Screen in the Biometry X Mode If the lens was also removed you must replace the lens tissue velocity of 1641 m s with the velocity in silicone oil 980 m sec If the Anterior chamber is also filled with oil the correct velocity must be typed in place of 1532 m s which is the tissue velocity in the Aqueous Pseudo phakic eyes when measuring eyes that have previously undergone cataract surgery the tissue velocity must be corrected for the implanted IOL The tissue velocity for PMMA IOL is 2718 m s for Acrylic IOL is 2120 m s and for Silicon IOL its 1049 m s Please note that
43. e echoes than early ones ideally it matches the extra attenuation exactly The degree of correction is set using the TGC slider The system will automatically set the end of the first zone at the surface of the retina 55 dG F2 dB 39 UMN 000002 Rev 2 E I OOO Measure B Scan and UBM Zoom and Color 40 Vector 1550 m z Calipers Vector 1550 m s Selecting Calipers replaces the Vector cursor with a pair of linear cursors that allow linear measurements of the image The cursors are placed by clicking on each end and dragging it to the required point They will move independently and there is no fixed relation between them In this mode the Profile window is frozen Zoom Color Clicking on Color creates a false color rendering of the image In B mode the color table is fixed Clicking on Zoom displays of the original image magnified 2 1 The original image is shown in the lower part of the screen with a box outlining the magnified area Clicking and dragging inside the box will slide it over the image to select the area to be magnified UMN 000002 Rev 2 I OOO Select Probe Position Scan Orientation Description Retinal Tear OTran Long O Axial TAS O Tran J Long ig n Mele Ui n ie 0 D 1 41 The Description field accepts a brief descri
44. ev 2 I OOO du 3 Snapshots Snapshots are the only files that are edited directly in the Files view Jun 10 53 AM Patients Files Reports Biometry Diagnostic Ascan B Scan UBM Utilities Description TI Eye Snapshot Che Jun 2005 Report File Jun 7 2005 B Scan Capture File May 21 2003 May 21 2003 Current Patient Retinal Tear Witren 126 all AScan ce of DEMO B Scan Report DEMO B Scan Capture File Delete Description Image of DEMO os Reset Snapshot Print Snapshot Generate Report F2 Shutdown Copy To Clipboard F3 Once a snapshot has been marked up it can be exported as an image file printed used to generate a report or copied to the clipboard for inclusion in another report The mark up information will not be saved automatically Click on Save As New to save the changes to a new file Clicking on Reset Snapshot clears the changes UMN 000002 Rev 2 62 F OOO Description Image of DEMO Os To enlarge TU mage click gh n king bo ion of inte es YA on n e anc click raw dr ing the mouse C She cursor on wil outl ine an at bg eng rage 5 the area selected but scaling the image too much will not give a usable enlargement Reset Snapshot Export Snapshot Save As Hew ajo PEDE Print Snapshot Generate Report F2 Clipboard
45. hamber It also provides a better ratio between the AL and PL echoes and the retinal echo Psuedophakic Lens Measurement x Technique Velocity m s Central Thickness Central thickness Fixed correction factor Correction factor OK Three options are offered for correcting for velocity variations in pseudo phakic patients Ultrasound Central Thickness and correction factor Ultrasound sets the tissue velocity for the lens to the correct value for the material and makes the measurement by identifying peaks as in a normal eye To use Central Thickness the user enters the thickness of the lens as supplied by the manufacturer in the dialog and this value is used to calculate the axial length If a fixed correction factor in diopters is entered the correction will be applied to the calculated refraction 53 UMN 000002 Rev 2 I OOO If the patient is a high myope checking High Myopia will modify system presets and the scan evaluation to improve ease of capture 4 High Myopia 5 Select the desired scan technique Scan Type 69 immers rn __ Vitreous 6 If the patient has had a total vitrectomy with silicone oil replacement select the correct option in Natural Silicone 980 Viscosity 1000cp the Vitreous box This sets sound velocity in the vitreous to the proper value for the oil used Viscosity 5000cp Silicone 1040 Cau
46. hamber IOLs FORMULA GIVING THE IMPLANT VALUE VERSUS THE DESIRED REFRACTION REF IOL Vs Ref if Ref ZO IOL lOLem emmetropia 1336 1 336R 0 33331 0 001 Ref 16 032R ALb Lb x L AC 1 336R 0 3333AC 0 001 Ref 16 032R 4AC ACx R 1336 1 336R 0 3333Lb 0 001 Ref 16 032R 4Lb Lb R FORMULA GIVING THE REFRACTION VERSUS THE DESIRED IMPLANT IOLAM Ref Vs IOL 1 336 16 032R AL Lx R 0 00L 0L Lb AC 16 032R 4AC AC x R 90 UMN 000002 Rev 2 9 HOLLADAY VARIABLES R Cornea curvature in mm 337 5 K K in Diopters Rer Target Refraction L4 AXIAL LENGTH CORRECTED FOR HOLLADAY L AL 0 200 mm SF SURGEON FACTOR SPECIFIC FOR HOLLADAY FORMULA SF A x 0 5663 65 60 where A is the SRK Constant ACH ANTERIOR CHAMBER CORRECTED FOR HOLLADAY Rag R except that if R lt 7mm then Rag 7 mm AG 12 5 23 45 AL except that if AG gt 13 5 then AG 13 5 mm ACD 0 56 Rag Rag 14 Ach ACD SF FORMULA GIVING THE IMPLANT VALUE VERSUS THE DESIRED REFRACTION OR AMETROPIA REF lOLam Vs Ref if Rc zO lOLam lOLem emmetropia IOLam a 13361 3366 0 33331 0 001 R q 16 032R 4L L x R L Aa 1 336R 0 3333 0 001 R 16 032R AA Ac x R FORMULA GIVING THE REFRACTION VERSUS THE DESIRED IMPLANT lOLam Rer Vs lOLam 1336 1 336R 0 33L IOLam L Ac 11 3368 0 3333A
47. he probe holder should be washed with warm water and a mild detergent to prevent build up of gel Probe handle and transducer The user must use the following procedures to clean the transducer and probe end daily Material Distilled water Soft facial tissue Photographic lens cleaning paper Procedure Keep the transducer and probe connected rinse the transducer and probe end Wet a piece of soft facial tissue absorb water remaining on the transducer surface and thoroughly with distilled water probe end by without rubbing Inspect carefully for salt build up on surfaces If there are any salt crystals wet lens cleaning paper with distilled water and then very lightly wipe clean any salt build up on the transducer surface If there is salt built up around the connector remove the transducer from the probe and use lens cleaning paper remove the build up Then reconnect the transducer and hand tighten Rinse the transducer and probe top end with distilled water Leave the transducer and probe to air dry UMN 000002 Rev 2 27 28 I OOO Note This maintenance procedure is not intended for disinfection of the transducer and probe Disinfection must still be performed between patient exams following the procedures outlined below Daily cleaning of the transducer and probe must be done at the end of the working day when no further exams are expected If an emergency examination must be performed outside normal wo
48. ile cursor to trace the axis of the cornea and lens This should give a profile similar to the one to the left If any of the peaks are low use another image Click on Chord Measure to display the cursors Ensure that the marker is correctly positioned on the anterior surface of the lens Drag the ends of the upper horizontal line to place it on the outer edges and parallel to the iris The ends of the lower line are placed on the sclera Verify that the upper and lower ends of the red vertical segment are on the anterior face of the cornea and the posterior face of the lens The chord lengths are displayed beside the chords UMN 000002 Rev 2 9 Description Retinal Tear Oos oo Description The Description field accepts a brief description of the pathology and identifies the eye that was scanned This information will be attached to the file when Save Movie is clicked Axial Tran E Long Scan Probe Orientation Markers are provided for longitudinal transverse and axial views Indicate the probe position by selecting the view then clicking on the correct location to show the probe orientation J Long UMN 000002 Rev 2 49 I OOO 3 Biometry Before starting a scan transducers must be cleaned and disinfected See Pages 26 31 The system should be calibrated regularly See Page 50 NOTE It is the operator s responsibility to place the pro
49. ion of either ALKAZYME or ANIOZYME for 5 to 15 minutes depending on the perceived level of risk Clean the probe and the cable in the chosen solution for 1 minute using the brush Rinse the probe and the cable in de mineralized or distilled water Do not wet the connectors Dip the probe and the cable in the Alkacide solution for 5 to 20 minutes depending on the estimated level of risk Do not wet the connectors Rinse the probe and cable with de mineralized or distilled water Keep the connectors dry 5 Dry with sterile compress or a single use dry wipe if the rinsing water was sterile 6 The probe is ready for use 7 UMN 000002 Rev 2 31 du I OOO Protocol for High Risk Patients Reminder Disconnect the probes from the machines Machines must be turned off first Avoid any contact between liquids and the electrical connectors at the ends of the probes Decontamination Pre disinfection Immerse the probe and the cable except for the connector in a solution of either ALKAZYME or ANIOZYME for 5 to 15 minutes depending on the perceived level of risk Clean the probe and the cable in the chosen solution for 1 minute using the brush Do not splash the connectors Rinse the probe and the cable in de mineralized or distilled water Do not wet the connectors Immerse the probe and the cable except for the connector in a 6 chlorometric degree solution of sodium hypochloride for 60 min at 20 C ensuring the
50. n dialog HUE HS Selecting Export will open oo E ECT ER the dialog for selecting a My Documents destination for the exported file Any volume mounted a Network Places by the Windows file system jultrasaund 5 5 to pc ubm may be used Once the desired location is highlighted clicking Save File name will copy the file Save as type Files Cancel 79 UMN 000002 Rev 2 80 N 2 The Clipboard Clipboard Clear The clipboard is used to store individual B scan frames A scan curves and images recovered from Snapshot files for inclusion in a report The data can come from alternative views of the Same patient for a longitudinal study or to gather all available data on a complex case or from different patients for lateral studies Images are saved the clipboard by clicking Copy to Clipboard when the button is visible Clear will erase the contents of the clipboard An image is selected by clicking on it Double clicking will open the annotation editor UMN 000002 Rev 2 I OOO Image Editor Reset Snapshot 9 50 mm 1 ff Cancel OK 81 The clipboard image editor can be used to insert markers in an image before it is included in a report Four pointers can be placed and arbitrary outlines drawn The image can also be zoomed 2X UMN 000002 R
51. ncipal tab bar The opening screen is generally the Patient Data screen The operator is not required to identify the patient before starting the examination this can be done at any time during the exam and if no patient has been selected when Save is clicked the operator is automatically taken into the database to select the appropriate patient record or create a new one Warning the same patient will be used for all saves until another has been selected The patient information screen has been organised to display full information and a list of saved examinations for the selected patient summary information about the images is displayed including any notes on probe orientation that were recorded at the time the image was captured and saved When an exam is selected a simplified view is presented so that the user can review it It is possible to copy and delete saved examinations one at a time The printing system has been designed to use the default printer and provide access to the control functions available from the printer drivers Curves are printed in black on white reducing ink consumption 6 UMN 000002 Rev 2 du I OOO Chapter 1 Characteristics 1 Description The OTI Scan 3000 modular ultrasound system is an ultrasonic diagnostic system intended to be used for ophthalmic applications Scans can be made in Immersion Mode or by placing the probe directly on the eye UBM scans require the use of an immersion cup
52. ole to select the slider and rotating the knob The highlighted slider is currently being controlled These controls must be adjusted to obtain the best image while scanning while they have the same visual effects a frozen image it is important to remember that they are acting on stored data If the data is not captured when the image is made the detail cannot be created later by adjusting these controls 1 When Show focus is checked lines are projected on the image indicating the focal zone of the transducer This is the area where the image resolution is best As far as possible the structure of interest should be kept in this zone 73 48 Show focus 43 UMN 000002 Rev 2 I OOO Zoom 44 Clicking on Zoom displays of the original image magnified 2 1 The original image is shown in the lower part of the screen with a box outlining the magnified area Clicking and dragging inside the box will slide it over the image to select the area to be magnified UMN 000002 Rev 2 N N Measurements There are five measurement modes in the HF Vector 155 m z module Vector 1550 15 cross vector measurement Calipers gives two simultaneous linear measurements on the image Angle measure intended for measuring the anterior chamber angle displays the angle defined by the cursors Biometry measures distance along the optic axis using the correct sound velocity for e
53. ols am Vector 1550 m s 21 Retina zi Shutdown Zoom Color Display The B scan module shows the image with a simultaneous A scan profile Start recording by clicking Live or pressing the right footswitch Live end by pressing the right footswitch or pressing Stop The recording be played back using the controls below the Frame Counter bar Particular frames are selected using the Left and Right buttons or dragging the cursor along the bar A specific section of the recording Loop Play can be selected for playback by placing the green Start and red Stop markers inside the Frame bar These are the frames that will be saved to the patient s folder if this option is available The slider on the bar indicates the position of the current frame in the recording and can be used to move through the sequence by clicking and dragging 2D Dynamic Recording Half Speed The A Scan Vector Profile cursor is the green and red line running through the B Scan image The Vector Profile displays the intensity of the echoes in the image as a classic A Scan curve Clicking and dragging its left end changes the e vertical position of the cursor Clicking and dragging the right end changes the angle 8 The profile is displayed in the window below the image linear measurements are made by dragging the vertical cursors to the appropriate points on the profile The red section of the Profile cursor show
54. or Display S Select eve ERBEN xl Many functions require information about the eye that was scanned If this has not been entered starting these operations will open a dialog requesting cos Left Pedal C Right Pedal that the eye be specified This can be done by clicking on the button or pressing the corresponding footswitch pedal Which eye was scanned Cu 34 UMN 000002 Rev 2 Sp 000 Footswitches A Scan Footswitch B Scan and UBM Footswitch 35 For all B and UBM systems the USB footswitch shown to the left is supplied The left and right pedals have the functions displayed on the footswitch icon The centre pedal acts like clicking OK in a dialogue box or it moves the focus between any of the 4 slider controls that are visible Gain Contrast TGC and the Frame Counter See Page 38 UMN 000002 Rev 2 9 1 B Scan Before starting a scan transducers must be cleaned and disinfected See Pages 26 31 Patients Files Reports Biometry Diagnostic B Scan Utilities 2D Dynamic Recording ms Probe 20 2 50 d z Jun7 10 26 AM ge 7 TGC Dyn Gain Current Patient 41 BAI Retinal Tear vitreo Loop Play 28 t Half Speed Clipboard Description Tran C Long Axial lt 1 0 8508 8298 General Contr
55. ption of the pathology and identifies the eye that was scanned This information will be attached to the file when Save Movie is clicked Position Marks Indicate the probe position by selecting the view then clicking on the correct location to show the probe orientation provided for Markers transverse longitudinal and axial Views UMN 000002 Rev 2 du I OOO 2 High Frequency B Scan UBM Before starting a scan transducers must be cleaned and disinfected See Pages 26 31 To enter the UBM module click on the UBM tab Aside from the probe selection and measurement functions it is identical in operation to the B scan module Patients Files Reports Biometry Diagnostic Ascan B Scan UBM Utilities 2D Dynamic Recording Probe HF35MHz Jun 8 10 30 Current Patient Pigment dispersion mm Loop Play Half Speed 27 166 Show Focus Description General Controls m Before Print Display F1 save Moyie os C Generate Report F2 C Tran Long Axial _ Copy to Cipbosra ra to Leto T3 a 2 pe Snapshot F4 LI Vector 1550 m s Zoom Shutdown Color Display Scans be made using the 35 or 5OMHz transducer the system offers an image sector of 18 as well as the standard 34 with twice the frame rate for the narrower sector Click on Probe to
56. r measured before the Keratectomy Contact Lens Method Adjustment Method subtract 0 25D from the Ks for every diopter of myopia corrected PIGGYBACK IMPLANTS fracti __ Error Refractive Error 0 03 138 3 A 138 3 A 0 5 fracti Error Refractive Error 0 04 138 3 A 138 3 A 0 5 93 UMN 000002 Rev 2
57. ranty extended warranties are optionally available The following items are not covered e Physical damage to the unit or probes due to misuse or shock Damage or data loss due to power failures or fluctuations The use of a line interactive UPS is recommended to avoid these types of failures e 1055 or corruption of data or software due to user error or the installation or use of any third party hardware or software e Damage to transducers caused by autoclaving or exposure to excessive heat e Repairs not covered by warranty will be invoiced on the basis of parts and labour At OPTOS discretion the damaged component may be exchanged at a flat rate Networking OPTOS does not provide support for the operation of its products in a network environment Connection to and operation on any network is entirely the responsibility of the user Where installation or use of any network hardware or software interferes with the normal operation of the OPTOS product that product must be returned to normal operation at the user s expense When the connection of an OPTOS product to or installation of OPTOS supplied software on a network interferes with the operation of the network the product must be removed from the network alternatively the problem may be resolved by the user in cooperation with the network owner at their expense Third Party Software OPTOS does not provide support for the use or installation of any software obtained from a
58. rking hours the probe and transducer must be disinfected and completely cleaned immediately afterwards Disinfection The probe must be cleaned and disinfected between patients to prevent the transmission of infections It is the user s responsibility to ensure that the relevant standards are maintained and that the products and procedures are effective and appropriate for ophthalmic applications The following information is provided for the guidance of users and specific products are mentioned for illustration only OPTOS does not endorse the use of these or any other product Products must be used in accordance with the manufacturer s instructions FOR U S A ONLY How to prevent patient to patient transfer of infection The probe must be cleaned between two patients to prevent patient to patient transfer of infection The probe may be cleaned using Cidex liquid disinfectant usually found in hospitals Other FDA cleared disinfectants may also be used Probes and cables can be immersed up to the connector Do not immerse the connectors Do not autoclave the probe or the cable After cleaning rinse the end of the probe thoroughly with clean water to remove all traces of the liquid used Follow the instructions on the label of the disinfectants The surfaces should then be dried with a lint free cloth UMN 000002 Rev 2 29 I OOO FOR EUROPE PRECAUTIONS TO BE TAKEN TO AVOID THE SPREAD OF INFECTIOUS DISEASES
59. s the interval being measured 36 UMN 000002 Rev 2 I OOO Change Velocity Change Velocity To ensure accurate length measurements the tissue velocity must be set to an appropriate value for the eye being examined Where there has been a m 2 vitrectomy with silicone oil replacement or the measurement range includes other structures where the velocity differs from the normal 1532m s the correct value can be entered by clicking Change Velocity and entering the new value in the dialog box In complex cases it may be necessary to make the measurement in segments entering a value for each segment In this situation the Clipboard can be used to store each segment for inclusion in the report Caution The velocity will be set at the new value until it is changed again or the program terminates 537 0 m Enter the new vitreous speed Cancel DH 37 UMN 000002 Rev 2 I OOO Select Probe Frequency Probe 20MHZ 504 Transducer frequency and sweep angle are selected from the Probe list 20 50 d The probe be applied directly the eye or used with an immersion To start scan place gel on the probe and place the probe on the eye or place the cup on the eye and fill with sterile saline and click on to start the transducer moving Place the probe in the cup and move it towards the eye until the cornea appears at the bottom of the image Caution Appl
60. th with the stored value If the calibration succeeds the window will display Calibrated and may be closed If the calibration fails contact OPTOS immediately The blue rectangle beside the Calibrate button will turn green when the system is properly calibrated or red if calibration fails Note The test block will expand and contract with changes in ambient temperature If the unit is operated outside the specified temperature range calibration may fail 51 UMN 000002 Rev 2 I OOO A Scan Examination 1 In A mode pressing the right footswitch will Start Stop a scan Pressing the left pedal will create a Report 2 Enter the Description and select the eye l Jmm 3 Click the corresponding tab to scan the other eye o mcum 32 UMN 000002 Rev 2 9 Select the lens IOL type the eye ens type Default 72 Aphakic C PMMA Acrylic z 2 Silicone Dense Cataract If there are problems obtaining adequate scans because of a very mature cataract click on Dense Cataract NOTE Dense mode offers a compromise between Log Amplification and Linear Amplification It provides higher echoes from main structures in the eye such as Anterior Lens AL and Posterior Lens PL as well as Retinal echoes while lower echoes are suppressed In Biometry it offers easier acquisition and display for patients with dense cataract and or a shallow anterior c
61. tion Choosing the wrong vitreous material will create serious errors in the axial length and calculation result UMN 000002 Rev 2 54 du I OOO 7 Place the probe on the cornea or in the immersion cup When Live is clicked or the left footswitch pressed the system will start recording scans keeping the best 9 that have been recorded The height of the scan is adjusted using the Gain slider or with the knob on the console Caution Applying excessive pressure to the probe will cause discomfort for the patient and distort the eye resulting in incorrect measurements Live eee oa dm Gain e 1 00 The system records the data during scanning For manual evaluation and capture of scans this recording can be played back using the standard controls Start Stop Left Right Beginning and End frame also be found dragging the cursor on the Frame Bar Next Capture will move to the next scan that the software identifies as acceptable Recording view Selected table entry view gt The axial length is displayed for each scan with its three components the anterior chamber lens and vitreous The measurement cursors are positioned on the scan by clicking on them and dragging to the desired point Click on Add see next page to add the scan to the list The yellow and blue horizontal bars on the scale show the zones that are searched for the lens surf
62. y differs from the normal 1532m s the correct value can be entered by clicking Change Velocity and entering the new value in the dialog box In complex cases it may be necessary to make the measurement in segments entering a value for each segment In this situation the Clipboard can be used to store each segment for inclusion in the report Caution The velocity will be set at the new value until it is changed again or the program terminates 537 0 Enter the new vitreous speed Cancel 62 UMN 000002 Rev 2 du I OOO 5 Utilities The Utilities module contains a number of functions that are opened by clicking their tabs Lane or Default Report Header Confirm Image Store ExportFolder r OJf 5can Report Ask for clipboard comments Patient Lo 55 pis 3 09 PM Version Information Advanced User Current Patient cr attic prova test Suppress Print Dialog Expand Print Margins Edit Clipboard Default Report Footer Ophthalmic Technologies Inc A amp Scan Diopter Interval far Reports 05 Readings in mm Manual Freezing Edit Language Preference Engish r Snund Disable Sound Shutdown The Preferences page has controls for editing the header and footer of the report pages and controlling the display of various features in the software 63 UMN 000002 Rev 2
63. ying excessive pressure to the probe will cause discomfort for the patient and distort the eye Live Select Scanning Zone Depth Orbit mode The normal scan depth is 37mm from the face of Retina zl the probe Selecting Orbit improves visualization of deep structures the field of view is then 8 45mm Retina Obi 38 UMN 000002 Rev 2 du I OOO Image Adjustments These three sliders control the TGC brightness and contrast of TGC Dyn the image When the image is live they are set either by clicking and dragging the slider with the mouse or turning the control knob on the console The highlighted slider is currently being controlled by the knob it may be changed either by clicking with the mouse or by pressing amp releasing the knob These controls must be adjusted to obtain the best image while scanning while they have the same visual effects on a frozen image it is important to remember that they are acting on stored data If the data is not captured when the image is made the detail cannot be created later by adjusting these controls Time Gain Compensation TGC corrects the image for the natural attenuation of ultrasound in tissue Less sound reaches deep tissues and the echoes are correspondingly weaker This is seen on the screen as a fainter echo even when the tissue has in fact the same reflectivity as one nearer the probe The TGC system compensates by applying more gain to lat

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