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- Frank`s Hospital Workshop

1. 115 0 3 21 48 115 1 3 27 42 115 2 3 33 36 115 3 3 39 31 115 4 3 45 25 115 5 3 51 19 115 6 3 56 14 115 7 3 62 08 115 8 3 68 02 115 9 3 74 03 116 0 3 80 09 116 1 3 86 15 116 2 3 91 20 116 3 3 97 26 116 4 4 03 32 116 5 4 09 37 116 6 4 15 43 116 7 4 21 49 116 8 4 26 54 116 9 4 32 60 117 0 4 38 66 117 1 4 44 11 117 2 4 50 AT 117 3 4 56 83 117 4 4 62 88 117 5 4 67 94 117 6 4 73 1 00 117 7 4 79 1 05 117 8 4 85 1 11 117 9 4 91 1 17 118 0 4 96 1 22 118 1 5 02 1 28 118 2 5 08 1 34 118 3 5 14 1 39 118 4 5 20 1 45 118 5 5 26 1 51 118 6 5 32 1 56 118 7 5 37 1 62 118 8 5 43 1 68 118 9 5 49 1 73 119 0 5 55 1 79 119 1 5 61 1 85 119 2 5 66 1 90 119 3 5 72 1 96 119 4 5 78 2 02 119 5 5 84 2 07 119 6 5 90 2 13 119 7 5 96 2 19 119 8 6 02 2 24 119 9 6 07 2 30 continued on next page 1 23 OcuScan RxP Measuring System Table 1 5 Lens Constant Conversion Table continued from previous page Anterior Chamber Surgeon Factor A CONSTANT D pissed A CONSTANT D Depth mm 120 0 6 13 122 6 7 65 3 83 120 1 6 19 241 122 7 7 71 3 89 120 2 6 25 122 8 7 77 3 94 120 3 6 31 2 53 122 9 7 82 4 00 120 4 6 37 123 0 7 88 4 05 120 5 6 42 2 64 123 1 7 94 4 11 12
2. Packaging Not applicable Sterilization Not applicable Whenever the system is not in service it should be covered with its dust cover The dust cover Storage protects the console and monitor from airborne particles and also offers protection against accidental spills ADDITIONAL INFORMATION Start with a commercial Combine this E To obtain 100 ml of E With this E a solution of sodium amount of sodium sodium hypochlorite amount of A hypochlorite such as hypochlorite distilled water solution ppm ppm available chlorine solution available chlorine Dilution Guide 5 50 000 ppm 40 ml 1 2 5 dilution 60 ml 296 20 000 ppm 596 50 000 ppm 10 ml 1 10 dilution 90 ml 0 5 5 000 ppm 296 20 000 ppm Undiluted n a 296 20 000 ppm 296 20 000 ppm 25 ml 1 4 dilution 75 ml 0 5 5 000 ppm 196 10 000 ppm 50 ml 1 2 dilution 50 ml 0 5 5 000 ppm Manufacturer Contact By phone Contact Technical Services in the USA at 800 832 7827 or contact the local Alcon representative By mail Alcon Technical Services 15800 Alton Parkway Irvine CA 92618 USA Note Each probe is identified by a serial number which should be given to the Alcon representative when discussing the probe This provides traceability 8065750127 4 3 OcuScan RxP Measuring System Installing Paper into the Printer 4 4 NOTE When the paper nears the end of the roll a red stripe will appear on one edge Whe
3. Interference may occur in the vicinity of equipment marked with the following symbol o Note 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To access the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the equipment or system is used exceeds the applicable RF compliance level above the equipment or system should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the OcuScan RxP Measuring System 8065750127 Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m 1 9 OcuScan RxP Measuring System The OcuScan RxP Measuring System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the OcuScan RxP Measuring System can help prevent electromagnetic interference by ma
4. f My Computer File Edit View Favorites Tools Help Back KAsearch Folders Address B My Computer ges m m x a E ii ae Alcon My Documents NETWORK Program Files My Computer storage Cari po G a Temp Windows Control Panel Docfile26857 fe EJ EJ EJ EJ E Docfile28101 Docfile28683 Docfile29665 Docfile30320 mdmlogi OcuScan RxP Measuring System Double Click My Computer Mobile Device File Edit View Favorites Tools Help Back amp Q Search Ly Folder Address B Mobile Device CDU 8 Meee Alcon C Alcon VB App Mobile Device App f 47 i My Computer far ae Microsoft My Documents Pocket Word Ghistory US DE X x Double Click Patient Files Storage Card File Edit View Favorites Tools Help Back search Gy Fob Address ers History C Storage Card Patient Files Storage Card Patient Files Figure 3 32 Accessing Patient Files through a USB Connection This sequence of screens shows how to copy patient files to the PC Transferring Patient Data to a PC through an Ethernet Network Connection 1 Working with your network administrator connect the OcuScan RxP Measuring System to the local network through the ethernet port on the rear panel The device is configured as a DHCP client by default
5. oooooooooo o 3 6 Pull Report Printout rociar 3 7 Patient Records Screen src ana RH e CE es 3 9 Biometry Probe Check Sefesi persona dx ES EXER E EX a x Rai 3 11 Pachymetry Probe Check Sere osse parara radar di 3 12 The Biometry Presets Screens sre aaa 3 13 Immersion Technique 22309 rra reta dio mdr ia 3 15 Lens Constants Screen coso nara cd ia ates 3 19 Lens Constant Update Serenata PC E SUC 3 20 The Patient Frame vri eeu nera a 3 22 Whe Patient Information Screen uq 244 6 ceren REA race RC an 3 23 The Clinical History Method Screen ve asic decease dauwd ete REY 3 25 Th Biometry Scan 36feell eri v piov E EE E ES YO a S 3 27 sine the Eye Model oras neta rd 3 28 Display of Eye Model Echogram 2222 enhn ERE E YR Ry 3 29 Biometry Sean Screen Manual Mode 2 5005 ek y e RARE Y 3 30 Edit Gates SCIEN vo so ses RS ERA PERPE NEG e Bare AV qp DX am ded ddr 3 31 Biometry Details Screen crap 3 34 TOL Calculations Screen 2 Le Se Au A IRR RE ER RP ER RE E EE 3 45 Comparison SGIeOH ovde ue 2T PER VERE CREER abe eee EE I EHE RE Yn 3 38 Paehynmietry Presets SCIEN Wee sidt ie Gin en ed Rare E Ye VAS RE 3 39 Pachymetry Screen SEO oie 3 41 Pachymetry Patient Information Screen correrse radar RR RE 3 43 Pachymetry Single Point Screen is 2e lt ass0 cd ee eaued ER EE ad YT 3 44 8065750127 OcuScan RxP Measuring System FIGURE Figure 3 29 Figure 3 30 Figure 3 31 Figure 3 32 Figure 3 33 Figure 3 34 Figure 3 35 Figure 3 36 Fi
6. K 43 25 OS Left Eye Avg AL 24 17 AC 3 89 V 1532 1 24 17 24 18 24 17 24 17 24 17 24 17 24 17 24 17 24 17 24 17 3 94 4 48 15 75 SD 0 00 _ 24 17 rist IOL MA60BM Formula SRK T A 118 90 Emmetropia 19 40 IOL Power Refraction r 2nd A IOL Formula Emmetropia IOL Power MA30AC SRK T 118 40 18 85 Refraction r3rd IOL MTA4U0 Formula A 115 30 Emmetropia IOL Power SRK T 15 92 Refraction 3 7 OcuScan RxP Measuring System 11 Tap the drop down menu in the Save Patient Format field and select the default format for saving patient data Compact Flash or PC Format NOTE The format selected in the System Setup screen determines what files appear in the Patient Records screen For example if PC Format is selected then only those files saved in PC Format are displayed If Compact Flash format is selected then only files saved in Compact Flash format are displayed Compact Flash Binary The Compact Flash format should be used when saving patient data for backup purposes Files in this format cannot be viewed on a PC The advantage of this format is that it maximizes the number of patient files that can be saved to a Compact Flash card For example a patient file containing biometry and pachymetry data for both eyes will have a file size of approximately 70 KB Therefore a 128 MB Compact Flash card can hold a mini
7. the Biometry are Manual Auto Adjust gain Tap here to return Presets screen and S Auto from 40 800B to menu screen BIOMETRY SCAN Patient Frame Settings Contains Patient Preset Preseti data Tap on Operator Operator 1 screen to open Type Phakic Technique Immersion the Patient A A K1 D K UM L MA Mode Information screen Ko D 1555 1666 1555 Readings AUTO 1st Section Echogram Window P Displays an echogram of the current scan Tapping on the window in frozen state will switch to the Edit Gates state 8065750127 Captured axial length measurements 2nd Section Anterior chamber lens and vitreous measurements for the selected axial length 3rd Section Standard deviation and average axial length OD OS Button Tapping this button Print Save Button toggles between the Tapping this button OD and OS eye activates the action selected in the System setup Previous Next Screen Buttons Use these buttons to move through the screens Figure 3 17 THE BIOMETRY SCAN SCREEN This screen displays the echogram along with measurement readings for each eye Patient information and settings are displayed and can be changed by tapping on the frame containing the information The Biometry scan shows the axial length measurements of the eye The screen contains fields that display Patient information the current Settings Gain adjustment Mode selection a grap
8. 8065750127 OcuScan RxP Measuring System SECTION SIX ACCESSORIES AND PARTS Following is a list of Alcon approved accessories and replacement parts for the OcuScan RxP Measuring System Use of non approved accessories is not recommended For more information or for an updated list please contact your local Alcon representative or Phone Write 800 862 5266 or 817 293 0450 Alcon Inc ask for Customer Service 6201 South Freeway Fort Worth TX 73134 2099 ITEM CATALOG NUMBER OeuScan RxP Measuring S YM ad 8065741076 OcuScan RxP Accessories included with system Footswitch Assembly P MT 8065741075 cji M M EnS SKTE S 8065750130 Printer Paper 8065750128 Operators Ma o laa 8065750127 Power SPD idad 8065750728 OTUs hae 8065750213 USB Diver Patient Viewer CD edi 8065750398 OcuScan RxP Optional Items A eled Pachymetry Proberen onpi a E EE acechan 8065750122 Straight Pachymetry Proba sisi iia i 8065741077 Biometry Probe with Apolinar 8065741073 Biometry Probe without Applicator seco sdesdaccsacedetastnedddedsdisanddbeisedecoaseederavtenssints 8065750123 Compact Flash with Pachymetry ssionsrocamscoriacie tiendo aaa iaa 8065750222 Compact Flash Patient IS8oflls actora iii 8065750125 Compact Flash with Haigis Formula 2 sscissssasscsssnncensecsaasnbaconnnctadbcanssnaecmssviae 8065750124 Power Cord United States and Canada only v cesscesi
9. ne 1 L d n z d Rd R D refractive power of IOL D refractive corneal power R desired refraction n 1 336 refractive index of aequeous and vitreous n 1 3315 fictitious refractive index of cornea d 12 mm vertex distance between cornea and spectacles R average corneal radius L axial length measured by ultrasound d optical ACD Refraction R for given IOL power R q D where q n n D L d 1 d q D n L d d n D L d Optical ACD d For AC 0 d a0 al AC a2 L For AC 20 d a0 u al a2 v al L AC preoperative anterior chamber depth as measured by ultrasound L preoperative axial length as measured by ultrasound u 0 241 y 0 139 a0 al and a2 are constants describing the implant IOL IOL Constants aO al and a2 Standard a0 0 62467 A 72 434 where A A constant of the lens manufacturer al 0 4 a2 0 1 Optimized In optimized mode the constants a0 al and a2 are obtained by a separate optimization process For each patient the actual postop refraction is used to calculate the corresponding optical ACD For all patients these values are then correlated with the preop ultrasound measurements of the acoustical ACD and the axial length L Double linear regression analysis yields the constants a0 al and a2 The Haigis Formula works best when optimized constants are used OcuScan RxP is shipped with Standard constants but
10. 1 Type Phakic 1 K1 Immersion K2 56 K Adj 53 11 Age 50 Preset 1 Operator 1 Technique Immersion Gain Wto W 10 00 SEA E After Refractive Before Refractive Surgery Surgery Sphere Kt Cylinder K2 Vertex Avg K Before Refractive Surgery Sphere Cylinder Vertex After Refractive Surgery Sphere Cylinder Vertex Reading Velacity Thickness 20 66 20 64 20 54 20 63 20 54 20 64 20 64 20 64 20 64 20 64 AL AC 1532 3 44 3 44 3 44 3 42 3 42 L v 1639 1639 Reading Velocity Thickness AL AC 1632 3 44 3 42 3 42 3 44 L v 1638 1638 343 0 01 13 46 0 01 335 0 01 344 0 03 1345 0 02 377 0 02 Reading 6 TargetAmetropia 0 1stlOL SNBOTX Formula HOFFER Q ACD 5 20 Emmetropia 26 69 2ndlOL SABOD3 Formula HOFFER G ACD 5 02 Emmetropia 26 19 Emmetropia 26 69 Target Ametropia 0 3rd IOL MNBDAC Formula HOFFER Q ACD 5 20 1stlOL SNB TX ACD 5 20 Emmetropia 19 57 Formula HOFFER Q 2ndlOL SABOD3 Formula HOFFER Q ACD 5 02 Emmetropia 19 17 3rd IOL MNBOAC Formula HOFFER Q ACD 5 20 Emmetropia 19 57 IOL Power Retraction 25 50 0 82 26 00 0 48 26 50 0 13 27 00 0 22 27 50 0 57 28 00 0 92 28 50 1 28 29 00 1 65 29 50 2 02 IOL Power Refraction 25 00 0 83 25 50 0 48 26 00 0 14 26 50 0 22 27 00 0 58 27 50 0 94 28 00 1 30 28
11. 10 programmable points to console 3 3 A from an external power Map 1 or 2 25 programmable points module LASIK 3 points in each of four phases Physician settings 5 Insulation Class Class I type BF amp Display Continuous operation Single Point Min Avg SD Adjusted IOP Map 1 or 2 Last Average and Minimum readings LASIK Minimum reading Flap achieved Potential Ablation Ablated Potential Enhancement 1 14 8065750127 OcuScan RxP Measuring System gt EB N Le tO e pare e par o gt lt TYPE BF EQUIPMENT providing both the attributes of basic insulation and floated isolation Dangerous Voltage Used for U S Approval to Indicate Caution To reduce the risk of electric shock do not remove cover or back Refer servicing to qualified service personnel Attention consult ACCOMPANYING DOCUMENTS Alternating current Direct current Footswitch connection SVGA color video Protective ground Equipotential ground connection Ethernet Connection USB Connection RS232 Serial Connection Use appropriate take back system See Environmental Considerations in this manual e FORT WORTH TX 76134 2099 MADE IN USA DANGER RISK OF EXPLOSION IF USED IN THE po PRESENCE OF FLAMMABLE ANESTHETICS CAUTION GROUNDING RELIABILITY CAN ONLY BE ACHIEVE CONNECTED TO AN EQUIVALENT MARKED m HOSPITAL GRADE SR 100 120V 200 240V 2 04 C y 50 60 Hz REV MEDICALJELECTRI
12. Electrostatic discharge ESD IEC 61000 4 2 6 kV contact 8 kV air 6 kV contact 8 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast transient burst IEC 61000 4 4 2 kV for power supply lines 1 kV for input output lines 2 kV for power supply lines 1 kV for input output lines Mains power quality should be that of a typical commercial or hospital environment Surge IEC 601 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 lt 5 U gt 95 dip in U for 0 5 cycle 40 U 60 dip in U for 5 cycles 70 30 dip in U for 25 cycles lt 5 gt 95 dip in U for 5 sec lt 5 U gt 95 dip in U for 0 5 cycle 40 U 60 dip in U for 5 cycles 70 30 dip in U for 25 cycles lt 5 gt 95 dip in U for 5 sec Mains power quality should be that of a typical commercial or hospital environment If the uses of the OcuScar RxP Measuring System requires continued operation during power mains interruptions it is recommended that the OcuScar RxP Measuring System be powered from an uninterrup
13. The first time a new system is powered up it is important to configure it with your local information date time etc To fill in the System Setup data follow the instructions below 1 With the external power supply plugged into a power plug 110 120 220 240 VAC and its 24 VDC cable plugged into the OcuScan RxP rear panel the system will automatically turn on For systems using power supply PMP130 14 S press the toggle switch on the power supply to turn the system on The Power Up screen appears and an LED illuminates in the middle of the standby switch button to indicate that power is turned ON After the OcuScan RxP Measuring System performs a quick system self test the Menu screen appears on the display monitor see Figure 3 3 2 From the Menu screen select System Setup Clinic Tapping the clinic field displays a keyboard that allows a clinic name to be entered Used in Full Report printout and on PC Patient Viewer pagg program Clinic Default Operator D Date and Time Select the desired format then enter the correct values Language L Drop down menu allows the user to select from seven languages Display Brightness Adjustable between 10 and 100 Figure 3 4 Display Brightness Default Operator This drop down menu allows the user to select from five operators identified in the operator name field SYSTEM SETUP Sagt Jude Hospital ANC ETT ate Time MM DD YYYY y Format Form
14. is 15 to 15 D or corresponding value in mm Vertex range is 0 to 30 mm Adjusted K The Adjusted K is automatically calculated after the last value has been entered and then the Update button becomes active Pressing the Update button will enter the adjusted K value instead of the Avg K value on the main patient information screen 3 26 OcuScan RxP Measuring System 10 Enter the appropriate values for each field then press the Update button to 11 transfer the adjusted K value to the patient information screen Pressing the Esc button returns the system to the patient information screen without changing the Avg K value to Adj K Once you have returned to the Patient Information screen tap the Save button to save the changes made to the patient information Tap the Return arrow to return to the Biometry Scan screen 8065750127 OcuScan RxP Measuring System BIOMETRY SCANS This section will take you through the process of performing axial length measurements in Manual Automatic Auto and Super Auto S Auto modes NOTE It is recommended to measure both eyes to compare the measurements and avoid errors 1 From the Menu screen tap the Biometry button and the system will enter the Biometry Scan screen Figure 3 17 shows a typical screen with callouts describing each section Settings Frame Contains current Mode settings Tap on Tap button to change Screen to open mode Available modes Gain Menu
15. therefore it will automatically request an IP address from a DHCP server on the network Note If connecting to a static network please contact Technical Support for help on reconfiguring the OcuScan RxP 2 Launch a browser program such as Internet Explorer on a PC connected to the same network 3 Access the OcuScan RxP Measuring System by using the device name in the Address line of the browser as follows http NGO patientfiles see Figure 3 33 NOTE If the device name was changed from NGO default use the newly configured name 3 52 8065750127 OcuScan RxP Measuring System GO patientis Microsoft Internet Explorer provided by Alcon Laboratories Inc Be L yew Fortes Tools te Hus DAA Quee reme eem y Y C actress 8 eco ivaooocnrtest yer NGO patientfiles Jr ME To Parent Dire 5 12 03 5 12 03 5 15 09 5 23 09 5 31 03 yl 2 00 AM 100 AN 100 AM 00 AM 100 AN 2 Op Bua Figure 3 33 ACCESSING PATIENT FILES THROUGH A NETWORK Internet Explorer browser screen displaying the patientfiles on the OcuScan RxP Measuring System 4 Right click on the patient file s to transfer and select Save Target As Select the Patient files folder that was created see Figure 3 34 3x Save in Y Patient Files Y emet a PatientViewer xls History Desktop or aN My Computer e My Network Pa File name 1234 04 Save as type an Fil
16. 50 1 67 29 00 2 05 IOL Power Refraction 25 50 0 82 26 00 0 48 26 50 0 13 27 00 0 22 27 50 0 57 28 00 0 92 28 50 1 28 29 00 1 65 29 50 2 02 IOL Power Refraction 25 50 0 82 26 00 0 48 26 50 0 13 27 00 0 22 27 50 0 57 28 00 0 92 28 50 1 28 29 00 1 65 29 50 2 02 IOL Power Refraction 18 00 0 74 18 50 0 42 19 00 0 11 19 50 0 21 20 00 0 53 20 50 0 86 21 00 118 21 50 1 52 22 00 1 86 22 50 IOL Power Refraction 18 50 0 66 19 00 0 35 19 50 0 04 20 00 0 27 20 50 0 59 21 00 0 91 21 50 1 23 22 00 1 56 1 89 1 Figure 3 38 8065750127 BIOMETRY DATAIN THE PATIENT VIEWER This screen showsthe patient s biometry data displayed on a PC using the Patient Viewer 3 57 OcuScan RxP Measuring System 11 Click on the Pachymetry tab to view the pachymetry patient data as shown in Figure 3 39 PatientFiles Biometry Pachymetry System Settings Patient Name Wells Sam Patient ID 07 26 03 OD Right Eye OS Left Eye White to White 10 00 Preset 1 White to White 10 00 Preset 1 Corneal Velocity 1641 Operator 1 Corneal Velocity 1641 Operator 1 R B M B n R B M B 845 645 645 645 645 Min 644 642 646 644 645 644 Min 642 47 48 49 D Aya ON 6 7 5 m n Avg 644 645 645 646 644 644 SD 1 26 844 646 645 645 645 SD 126 Herndon Herndon Measured IOP 32 52 Adjusted IOP 25 52 Measured
17. B USB cable 1 2 Install the USB driver 1 1 Place the CD ROM provided with the OcuScan RxP Measuring System into the CD drive on the PC 1 2 Copy the following files to a location on the PC Wceusbsh inf and Weceusbsh sys 1 3 Start up the OcuScan RxP Measuring System and allow it to boot up 1 4 Connect a USB cable between the PC and the OcuScan RxP Measuring System 1 5 When prompted at the Add New Hardware screen follow the prompt and locate the driver Wceusbsh inf in the location it was copied to in step 1 2 Follow the directions displayed on the screen Install the Microsoft ActiveSync application This application can be downloaded via the internet at http www microsoft com mobile pocketpc downloads Select on the latest version of ActiveSync from Microsoft Downloads After downloading follow the installation instructions Windows is a Reg TM of Microsoft Corporation ActiveSync is a Reg TM of Microsoft Corporation 3 50 8065750127 OcuScan RxP Measuring System 3 Connecting to the PC 3 1 Power up OcuScan RxP Measuring System and allow it to boot up 3 2 After boot up connect the USB cable from the PC to OcuScan RxP Measuring System Note Older versions of ActiveSnyc require the USB cable to be disconnected and reconnected every time the PC is shut down On the OcuScan RxP Measuring System a dialog box will appear reporting that it is trying to connect to the host Do not click on
18. CA 1 336R 0 3333CA an 1 336 16 032R 4LC LC x R 0 001IOLam LC CA 16 032R 4CA CA x R 8065750127 147 OcuScan RxP Measuring System HOFFER Q FORMULAS P IOL power in Diopters A Axial length in mm R Refractive error at corneal plane Rx Refractive error at spectacle K K Average in Diopters C ACD Anterior Chamber Depth in mm pACD personalized ACD in lens constants Constants Refractive index of cornea 1 336 Retinal thickness factor 0 Vertex distance glasses 12 mm Hoffer Formula IOL Power R Rx 1 0 012 Rx P 1336 A C 0 05 1 336 1 336 K R C 0 05 1000 Hoffer Formula Refractive Error R 1 336 1 336 1336 A C 0 05 P C 0 05 1000 K Hoffer Q Formula Predicted ACD ACD pACD 0 3 A 23 5 tan KY 0 1 M 23 5 A tan 0 1 G A 0 99166 For Predicted ACD If A lt 18 5 then A 18 5 If A 31 0 then A 2 31 0 If Ax 23 then M 1 and G 28 If A223 then M 1 and G 223 5 8065750127 OcuScan RxP Measuring System 8065750127 SRK II FORMULAS P Emmetropic power I Desired IOL power Rf Refraction factor L Measured axial length mm K Averaged Keratometry D A SRK and SRK II A Constant Emmetropic power P A 2 5L 0 9K C C Correction with respect to original SRK formula w
19. Dip the biometry probe into water and place it on the eye model as shown with the probe positioned perpendicular to the base of the system 3 28 8065750127 OcuScan RxP Measuring System 8065750127 5 Press and release the footswitch The system is now in the Running state with the eye model echogram displayed in the graph window In the Running state the axial length is displayed in the upper right corner of the echogram and is continuously updated based on the current axial length of the echogram The following actions can be taken in this state e Adjust the gain e Analyze and save the current reading by pressing and releasing the footswitch within a half second period If the footswitch is not released within the half second period the system will return to the Running state without analyzing and saving the reading Goto the Frozen state by tapping the graph window 6 Adjust the position of the probe and gain until an echogram similar to that shown in Figure 3 19 is displayed then press and release the footswitch A live axial length reading is displayed on the echogram during the running state Figure 3 19 DISPLAY OF EYE MODEL ECHOGRAM Shown here is the echogram during the Running state in Manual mode Pressing and releasing the footswitch will analyze and save the echogram The system records the readings in Black Green on Pink color only if the acquired echogram meets software criteria for peak
20. Figure 3 5 DISPLAY MENU AND DEFINE REPORT POP UP WINDOWS Choosing Display Menu from the Records selections allows instant access to the Print pop up window when the Print Save button is pressed The Define Report window allows you to select the specific data to be printed 3 6 8065750127 OcuScan RxP Measuring System Figure 3 6 FULL REPORT PRINTOUT The Full Report depends upon measurements taken and K values entered Data must be present in order for a report to be printed If measurements were taken then the printout will contain most of the Scan screen information The Calculation Screen is printed if K values were entered Pachymetry screens are printed if pachymetry measurements were taken for the same patient This figure shows a printout of the Full Report for a patient who had measurements taken for the left eye only K values were entered so the IOL Calculation screen was also printed showing the various selections of IOL s and formulas used 8065750127 10 20 2005 06 31 Biometry Preset Pachymetry Preset Type Phakic K1 43 00 K2 43 50 K 43 25 White To White V1 12 MISSION HOSPITAL Patient Name Operator Age 52 JONES PAT ID 143262645 Dr 5m Dr 5m OS Left Eye AC 1532 Technique Immersion Mode AUTO Gain 64 Johnson ith ith L 1641 C C2 L1 1L2 FROZEN 00 JX O0_a0m0nN K1 43 00 K2 43 50
21. Number eseeeeennnnennnnnnnn 3 9 Compact Flash e nne 3 8 3 9 Immersion CENE 3 15 Compact Flash Patient Records 6 1 Immersion Mod CREE 5 2 Compact Flash Card cocos 1 5 2 1 3 23 Installation emen nennen nennen nennen nennen 1 3 Compact Flash Card Reader e 3 50 Installing Optional Software esse 1 4 Compact Flash With Haigis Formula cess 6 1 Installing Paper O ANE Ntc bgR SURE ER NDS 4 4 Compact Flash With Pachymetry rinine 6 1 Internal PRIN acia 2 2 Comparison Screen n 3 36 IOL se es 3 36 CONTAC MEET 3 14 IOL Calculation Formulas accionar 1 16 Copying Patient Data To A Personal Computer 3 49 IOL Calculation Screen sene 3 35 Corneal Thickness cee ens 1 4 IOI POW GM osa iria 5 2 Cornea Velocity es 3 40 IOP es 1 1 3 47 OP Adj sttrieht tons pat sd 3 47 D Bruce 3 5 K Decontamination ece eene 4 3 K Adjust o 3 24 Default Operator Wee DA MIR 3 5 KIANA PR 3 24 Define Report entree 3 6 Keratometer Index 3 17 Diagnostic Ultrasound DNNN 1 4 Keyboards AA A ca E 2 9 Dimensions essent tenens 114 KReadings sseeennn 3 35 Display Brightness O E A E TEE 3 5 KVallec ositos 3 36 DUST CIO eet ent Sie lia 6 1 8065750127 TA L Labelsiand ICOM icc iria 1 15 Language e MA 3 5 ECC eT crc 3 43 CEA A 3 41 A pL 3 34 Lens Const
22. Power vs Refraction for each combination Nine different IOL power calculations that would result in closest refraction around the target ametropia are displayed The user can then make a choice of IOL power that would be appropriate for the patient AC and AL values brought forward are the average of the ten readings on scan screen Values can be edited Patient Settings Name Pat Jones ac ECON EN Preset Dr Smith ID 143262645 K1 43 50 AVG K 42 75 Operator Johnson Type Phakic A 42 00 Target Ametropia Drop down menu IOL and 1st 2nd 3rd to pal Target Formula 4 SAGOAT 4 SAGOAT LASASIAT Ametropia Range selections Formula SRK T Formula HAIGIS m Formula HOLLADAY v is 10 to 10 A 118 40 A0 1 53 A1 0 40 A2 0 10 SF 1 45 ACD A or SF Emmetropia 21 05 Emmetropia 22 98 Emmetropia 21 18 displayed here IOL Power Refraction IOL Power Refraction IOL Power Refraction 8065750127 IOL Power nine different powers in 0 5D increments 21 50 22 00 Check box can be used to indicate which formula and IOL were used for a particular patient Figure 3 23 IOL CALCULATIONS SCREEN This screen is used by the operator to perform IOL power calculations If K readings were not entered in the Patient Information screen they must be entered here in order for the system to perform the IOL calculations For some formulas an ACD value may also be required Requirement for calculations to take place is a minimum of on
23. Preset PROBE CHECK Operator Operator 1 Technique Contact AC E 1532 1641 1532 FROZEN IN ll IN I m ij A lal Ma 31mm Figure 3 8 BIOMETRY PROBE CHECK SCREEN This screen is used to verify that the biometry probe is functioning properly 3 11 3 12 OcuScan RxP Measuring System Pachymetry Probe Check T From the Main Menu tap the Probe Check button The following message appears By entering any of the following options all patient data will be erased If you have a current patient with unsaved data tap the Esc button to go back and save the data then return to the probe check Tap the OK button to advance to the probe check Tap the Pachymetry button to select the pachymetry probe check The pachymetry probe check screen appears as shown in Figure 3 9 Select Auto mode if system is not in Auto mode already and the 300 1100 range for the eye model at back of system Place a thin layer of water on top of the eye model then position the pachymetry probe perpendicular to the top surface of the eye model Press the footswitch and wait for the system to take all the configured readings for one eye Note The probe must be perpendicular to the eye model in order for the system to detect a valid reading Verify that the system takes a measurement for each scan and all readings are relatively close to each other NOTE A slight tilt of the probe may cause a larger Standar
24. Rcor _ 1336 x C6 0 001 x Tam x C8 C4 x C5 0 001 x Tam x C9 IOLam Tam targeted or desired postoperative refraction D 1336 x C6 IOLam x C4 x C5 Tam 1 336 x C8 0 001 x IOLam x C4 x C9 8065750127 OcuScan RxP Measuring System 8065750127 HOLLADAY REVERSE SOLUTION OF SURGEON FACTOR I Power of IOL Diopters K Average K Reading Diopters K1 K2 2 R Average Corneal Radius mm 337 5 K SPH z Sphere Diopters CYL Cylinder Diopters Aref Actual postoperative spheroequivalent refraction SPH CYL 2 Alm modified axial length mm AL 0 200 V vertex distance mm Default Value 12 mm when Aref lt 4 or when Aref gt 4 user must input vertex distance Rag R if r lt 7 mm then Rag 7 mm AG 12 5 x AL 23 5 if AG gt 13 5 mm then AG 13 5 Rao AG ACD 0 56 ag VS8 A AQ 0 3333 0 001 x Aref 0 3333 x V R BQ 0 001 x Aref x 0 333 x Alm x V R x Alm 1 336 x V 0 333 x Alm 1 336 x R CQI 0 001 x Aref x V x 1 336 x R 0 3333 x Alm Alm x R CQ2 1336 1 336 x R 0 333 x Alm CQ1 I CQ3 z 1 336 x Alm x R 0 001336 x Aref x Alm x V x R CQ CQ3 CQ2 SF CBQ SORT BQ 4AQ x CQ 2 x AQ ACD OcuScan RxP Measuring System HAIGIS FORMULAS optional IOL Power for given refraction D D n n where z D R where D
25. Rmi cemere RE dires 3 34 FOOLS Wicho sa yankee ce consssseosiars 5 2 np T ITE 3 24 X Footswitch Assembly 6 1 Axial Lengths eines rea inerti 1 1 3 34 3 36 Footswitch Connector ssssssseeeeeee 2 3 Forced Freeze Capture sse 3 33 B Formula Configuration Screen sess 3 37 Blan arboladas 3 42 3 46 Front Panel inenen ae 2 1 BIO MVision abel 1 1 2 5 Frozen State sse nennen 3 27 Biometry Details Screen sssseeeess 3 34 Biometry Measurements In Manual Mode 3 28 G Biometry PA a 3 13 CAM Ala aa 3 14 Biometry Probe Check ceeeRRHnn ene 3 11 ELM ELM 2 5 Biometry Probe Connector emi 2 3 General Description ee 2 1 Biometry Probe Without Applicator 6 1 Biometry Probe With Applicator sees 6 1 o H Biometry A E 3 27 Haigis Formulas deci ea 1 22 Biometry Scans In Super automatic S auto Mode 3 33 Herndon c ar ene cum AM teni 3 47 Biometry Scan Screen 3 27 Hoffer Q Formulas iren nennen entren enne nenne 1 17 Holladay Reverse Solution Of Surgeon Factor 1 21 C Holladay Variable Sinimi 1 17 Cautions And Matninigs siria 16 HUM coco etes ctii eden 1 14 Cleaning The Console sess 4 1 Cleaning The Touch Screen ssssssssssss 4 1 mE I np E 3 4 Identification
26. The user can also move through the measurements by pressing and releasing the footswitch Once a measurement is selected holding the footswitch for 3 seconds will delete that measurement When a measurement is deleted the system will go into Running Saving state to acquire a new measurement The above process can be repeated to delete and retake additional measurements one at a time e Manual Mode To obtain a measurement press and release the footswitch to activate the ultrasound Place the probe on the eye and when the desired waveform is displayed press and release the footswitch to save the measurement The operator can repeat this procedure nine more times at which time gates are automatically placed on the echograph and the measurement is displayed in the reading box 8065750127 2 5 2 6 OcuScan RxP Measuring System Pachymetry Footswitch Functions Automatic Mode In automatic mode a thickness measurement is initiated by pressing a position button on the Pachymetry scan screen or by pressing and releasing the footswitch The position button will start blinking indicating that the system is ready to take a measurement In Map 1 or 2 hold the Pachymetry probe perpendicular to the cornea at the position that corresponds to the position button The system will take a reading then move to the next location and start blinking indicating that it is ready for the probe to be placed at that location After the system acquires the thick
27. cia 2 8 6 1 Power Input Module eeeeenee 2 3 Power SU pply e enun bn aE 2 8 6 1 Bilas Serene ERUIT 4 4 Printer Paper tiers aia ted Ente XM dE URS 6 1 Prllitolil ut n to c a in Refer irs 5 1 Probes ccccoocococccocononononononononccnnnononononononnnnrnnnanononononanons 2 7 4 2 Probe Check iiri eee seat 2 4 3 11 Probe Holdets ritiene cs 2 2 2 7 Pseudo And Phakic IOL Defaults sssse 3 18 R Fear Panel n eH ie pi enu ERR DIE 2 3 Refractive Error sisien oirnn ii asirai 3 25 Replacement PariS ooocccccnncccnnncccnnonenccnanennanencnnnnnnnrrnne 6 1 SAA 2 3 A eret ee rtr tenet 3 28 OcuScan RxP Measuring System S OU usina s 3 14 3 27 3 40 Safety Requirements sssrinin senses 1 12 SCKECMSAV Cl cs sci Eam SEE Era 3 2 Sellos tii cesare getan reed ideato me 3 4 Sequence segete tnde trei et ikea a te Rn ed 3 18 SOIVICO 4 1 Service Manual sse 6 1 Service Menu ssssesssseeeenenenen nennen 3 8 A ce Tees eisceniei eire eee EN 3 14 3 40 Settings Frame oed id 3 28 SOllp stretto eI eer 3 4 Single Point Screen ssseeeeeee 3 41 Single POINT m 3 43 hcic Ere 2 2 SPCCIICAUOMS E EET 1 14 SRK II Formulas eene 1 19 SHKI Formulas eicere unter ete he pe 1 20 Standard Deviation e t ee oe tends 3 34 Standby Switch eet tet er erre ined 2 2 6S 0 0 E EE 4 2 Straight Pachymetry Prob
28. components which must not undergo rough use or handling this can destroy or alter the operation of the probe 4 2 8065750127 OcuScar RxP Measuring System Table 4 1 Decontamination of Biometry and Pachymetry Probes WARNINGS 1 Do not use this product when corneal integrity is compromised by infection or trauma 2 The probes are fragile components which must be handled carefully to ensure proper operation 3 The probes should be cleaned immediately after use Do not use abrasive cleaners on the tips 4 The probes must be thoroughly rinsed after disinfection to protect the eye from residual solution Limitations on Reprocessing End of life is normally determined by wear and damage due to use INSTRUCTIONS Point of Use Before use Rinse the probe tip thoroughly with distilled water and dry with a soft clean cloth After use Clean and disinfect probe Replace the probe in its holder located on the side of the display with the probe tip pointing up Preparation for Decontamination Disassembly not required Cleaning Automated Not applicable Cleaning Manual Wipe the entire probe and cable with a cloth moistened with alcohol Only the tip of the biometry probe up to 15mm from the distal end and the clear conically shaped tip at the distal end of the pachymetry probe can be immersed Disinfection To inactivate Conventional Infectious Agents such as bacteria and fungi Immers
29. in the System Setup screen For example If PC Format is selected then only those files saved in PC Formatare displayed If Compact Flash formatis selected then only files saved in Compact Flash format are displayed 8065750127 3 9 3 10 OcuScan RxP Measuring System Uploaded Patient Data Uploaded patient data is data that was previously saved to the Compact Flash card then uploaded back into the system for viewing Uploaded patient data has the following characteristics e System settings that were saved along with patient data will be loaded back into the system e All up loaded settings as well as measurement data will be highlighted in yellow and will only be highlighted on screens that have data e All fields in the Patient Information screen except Patient ID can be modified e Ifa setting is changed a pop up message is displayed warning the user that the current patient measurements will be deleted If the new setting is accepted by tapping the checkmark the software will reload the current system settings last setting selected before upload make the requested setting change and restore the original default color NOTE System settings are changed in the Biometry and Pachymetry Presets screens e After a patient upload the user can only delete all the measurements for an eye and not individual ones e Date and time when the patient records were last saved are shown 8065750127 OcuScan RxP Measuring Sys
30. manual is written to help you learn to operate the OcuScan RxP Measuring System The operating instructions are written with the assumption that you have no previous experience with the OcuScan RxP Measuring System and start at system power up then continue on through System Setup Biometry Presets Patient Information and finally Biometry Scans If the optional Pachymetry software is installed instructions are also given for pachymetry setup and scanning The following flowchart shows the structure of the OcuScan RxP software and gives you an overall view of how to navigate in the system NOTE Pachymetry is an optional item that must be ordered in addition to the standard Biometry function See Section Six Accessories and Parts for information on ordering the Pachymetry option BIOMETRY Biometry PACHYMETRY Perform axial length Settings if option is installed measurements In the scan screen tap Perform corneal the Settings button to thickness measurements customize the scanning parameters Scan Patient Three modes available Information 2 lt gt Manual Auto S Auto In the scan screen tap the Patient button to enter patient data Scan Details Pachymetry Scans for 25 points A detailed table of ten A single point or Lasik measurements per eye in aoe ip is displayed ee the Settings button to 1 customize the scanning parameters IOL Calculations IOL power options are displayed based on selected f
31. mode or sleep mode and the screen will go blank Standby mode can also be entered by pressing the Standby switch on the front panel Systems with REF number 685 0000 502 can be reset by holding the Stand by switch for 7 seconds or longer then releasing it These actions will restart the system as in the power up cycle Alcon NGO Version 1 02 000 Figure 3 2 OCUSCAN RxP SCREENSAVER DISPLAY The screensaver display appears after the system has been inactive for ten minutes 8065750127 OcuScan RxP Measuring System The Menu Screen From the Menu screen the user may go directly to the Biometry screen or optional Pachymetry screen if installed Alternatively the user may elect to view the System Setup screen Patient Records or the Probe Check screen Menu Biometry gt Pachymetry a bc System Setup Lm Probe Check ON Figure 3 3 MENU SCREEN After the system transitions to the Menu screen the user can choose from the selections shown here shown with Pachymetry option installed Using the Touch Screen The OcuScan RxP Measuring System uses a touch screen user interface with the system The stylus provided with the system is the recommended tool to use when touching the screen to make selections A holder is located at the top of the system to conveniently store the stylus Selections are made by lightly tapping the stylus on the screen 8065750127 3 3 SYSTEM SETUP OcuScan RxP Measuring System
32. on in the Settings screen see Setting up the Biometry Presets NOTE A Patient ID is required to save patient data since it is used as the filename when saved to the Compact Flash card 7 Select the desired presets and operator from the respective drop down menus 8065750127 3 23 3 24 OcuScan RxP Measuring System OD Right Eye and OS Left Eye The following parameters are available in the OD Right Eye and OS Left Eye frames Type The selections here are Phakic Aphakic Pseudo Phakic and Phakic IOL Pseudo Phakic has several subtypes that include Pseudo Acrylic Pseudo PMMA and Pseudo Custom1 3 The Phakic IOL selection is used for biometry examinations of patients with IOL implants Phakic IOL contains several subtypes as follows Phakic Acrylic Phakic PMMA and Phakic Custom4 6 The Pseudo Custom and Phakic Custom selections give the user the ability to enter his commonly used lens such as silicone etc The custom parameters must be entered for the lens velocity and center thickness AC L V The velocity in meter sec that the ultrasound passes through the Anterior Chamber AC Lens L and Vitreous V The lens field is not displayed in Aphakic In the Psuedo Phakic L and Phakic IOL P types there is an additional field to input the lens center thickness Velocity defaults are provided from the Settings screen but it is possible to change the velocity in the patient screen For example the patient may hav
33. returns to scan screen Figure 3 21 EDIT GATES SCREEN In this screen the selected gate can be repositioned and the associated readings will be automatically recalculated 10 Select a gate to reposition by tapping the Gate Select button Tapping the button 11 12 13 again moves the selection to the next gate Reposition the gate by touching the screen at the desired location The gate instantly moves to the new position and the system displays a vertical line showing the new position of the selected gate as shown in Figure 3 21 Fine adjustments are made using the Gate arrow buttons The echogram may change color depending upon its new relationship to the calculated average Avg of all the measurements Green indicates a measurement that is closest to the average Pink indicates a measurement that is farthest from the average Black indicates a measurement in between Green and Pink Blue indicates a measurement that was acquired using the force freeze function because the waveforms were outside the normal software criteria Tap the Zoom button This button enables the user to magnify the selected gate area which is particularly useful when using the arrow buttons for fine adjustments Tap the Zoom button again to return to the normal view Press OK to accept the changes or Esc to cancel The system returns to the normal scan screen in the Frozen state 3 31 OcuScan RxP Measuring System Biometry Measure
34. selected on the IOL Calculations screen The Configured IOL Calculation screen is available to show calculations using a specified formula for different axial length ranges 8065750127 OcuScan RxP Measuring System PACHYMETRY SETTING UP THE PACHYMETRY PRESETS The system allows the user to set default measurement parameters for up to five preset screens 1 From the Menu screen tap the Pachymetry button to enter the Pachymetry Scan screen 2 Tap the Settings frame The Pachymetry Presets screen appears as shown in Figure 3 25 Mode Set the default scanning mode to Manual Auto or S Auto Cornea Velocity Available range for default velocity value between 1000 and 2000 Screen Set default pachymetry screen to Single Point factory default Map 1 Map 2 or Lasik Volume Bias rcm 5 Set the default volume level for each preset Audio Feedback A beeping based feedback signal that increases in speed as the probe approaches perpendicularity Figure 3 25 Settings Audio Feedback Preset Number Five presets are available to customize the parameters shown on this screen PACHYMETRY PRESETS Mode Cornea Velocity 164 1 Screen Screen Setup Thickness Range 400 To 700 Lasik Targets Flap Thickness um Residual Bed um Eo a Select the bias type for each preset from actual percentage or absolute Volume Percentage and absolute values can be ch
35. than 3 seconds the selected reading will be erased and the system will go into running state to reacquire the deleted reading The previous steps can be repeated to delete and re take additional readings Selecting a reading from the readings window will display the associated echogram and its AC L and V components The individual gates may be edited by tapping on the echogram window to enter the Edit Gates state 10 12 2005 21 29 1 12 BIOMETRY SCAN pa o Semus Deleted reading Name Preset Preseti 5 ID Operator Operator 1 Type Phakic Technique Contact 7 E Reading s farthest K1 D e m b Mode t from the Avg axial AUTO 2 length are pink FROZEN 7 The first reading z x closest to the Avg axial length is selected Reading s closest to the Avg axial length are green Average axial length of the ten readings Waveform changes f color to match the Delete button Deletes selected reading Pressing and selected reading holding the button for more than 1 second will display the option to delete all readings Figure 3 20 BIOMETRY SCAN SCREEN MANUAL MODE After analyzing and saving ten echograms the system automatically selects the scan that is closest to the average axial length 8 Select a reading from the Readings window by tapping on the reading The echogram for that reading is displayed in the echogram window Editing the Gate Positions If not all required
36. to the current patient s condition 9 Tapthe K Adjust button The Clinical History Method screen appears as shown in Figure 3 16 CLINICAL HISTORY METHOD Refractive error numbers must 1 K values BEFORE refractive surgery retain their corresponding signs 4 for hyperopic and for myopic and S84 1 00 D software will correct the numbers Avg K 42 00 D for vertex distance Enter values by re 43 00 E tapping on the associated field 2 Refractive error BEFORE refractive surgery Suc co y Cylinder EE 13 00 fan 3 Refractive error AFTER refractive surgery Note Do not use current refractive error as the patient may have a myopic shift due to the presence of a cataract Sphere D EN 1 30 DE 4813 00 fii Adjusted K 4405 D Update Figure 3 16 THE CLINICAL HISTORY METHOD SCREEN This is the preferred method for adjusting the K values for patients who have had refractive surgery and have accurate prior records containing the required data K values BEFORE refractive surgery The acceptable range for K1 is 28 D 12 05 mm to 62 D 5 45 mm while K2 is 28 D 12 05 mm to 68 D 4 96 mm Refractive error BEFORE refractive surgery Range for Sphere is 15 to 15 D or corresponding value in mm Range for Cylinder is 15 to 15 D or corresponding value in mm Vertex range is 0 to 30 mm Refractive error AFTER refractive surgery Range for Sphere is 15 to 15 D or corresponding value in mm Range for Cylinder
37. 0 6 6 48 123 2 8 00 4 17 120 7 6 54 2 75 123 3 8 06 4 22 120 8 6 60 123 4 8 12 4 28 120 9 6 66 2 87 123 5 8 18 4 34 121 0 6 72 123 6 8 23 4 39 121 1 6 77 2 98 123 7 8 29 4 45 121 2 6 83 123 8 8 35 4 51 121 3 6 89 3 09 123 9 8 41 4 56 121 4 6 95 124 0 8 47 4 62 121 5 7 01 3 21 124 1 8 53 4 68 121 6 7 07 124 2 8 58 4 73 1217 7 12 3 32 124 3 8 64 4 79 121 8 7 18 124 4 8 70 4 85 121 9 7 24 3 43 124 5 8 76 4 90 122 0 7 30 124 6 8 82 4 96 122 1 7 36 3 55 124 7 8 88 5 02 122 2 7 42 124 8 8 93 5 07 122 3 7 47 3 66 124 9 8 99 5 13 122 4 7 53 3 72 125 0 9 05 5 19 122 5 7 59 3 77 Bibliographies 1 John A Retzlaff Donald R Sanders and Manus Kraff Lens Implant Power Calculation 3rd Edi tion Thorofare NJ SLACK Incorporated 1980 2 Kenneth J Hoffer M D The Hoffer Q Formula A comparison of Theoretic and Regression For mulas J Cataract Refract Surg Vol 19 November 1993 3 Jack T Holladay MD MSEE Standardizing Constants for Ultrasonic Biometry Keratometry and Intraocular Lens Power Calculations J Cataract Refract Surg Vol 23 November 1997 4 Jack T Holladay MD MSEE International Intraocular Lens amp Implant Registry 2002 J Cataract Refract Surg 2002 28 152 174 LAST PAGE OF SECTION 1 24 8065750127 OcuScan RxP Measuring System SECTION TWO DESCRIPTION General Description The OcuScan RxP Measuring System is a diagnostic tool used by ophthalmic surgeons for pre and post operative d
38. 50 The default formulas are Hoffer Q for the first range Holladay for the 2nd and SRK T for 3rd but the user must accept these formulas or select different ones for those ranges before it is activated Enter the desired range and select the desired formula for each axial length section then tap OK to go to the Configured IOL Calculation screen The Configured IOL Calculation screen is displayed as shown in Figure 3 24 with a chart for each of the IOL s selected in the IOL calculation screen see Figure 3 23 The formula used to calculate the charts is listed above along with the basic patient information NOTES After entering the Configured IOL Calculation screen the system will now use it as the default comparison screen for the current preset To return to the default Comparison screen tap the Formula Config button then tap the X button in the upper right corner of the dialog box When formula configure is activated it will replace the Comparison screen in the define report window Tap the right arrow button to advance to the next screen At the Patient Information screen save the patient data by tapping on the Save button If you selected Display Menu in the System Setup screen for the action of the Print Save button you can also tap the Records button then tap Save refer to page 3 6 for detailed information on the Print Save button 3 38 Figure 3 24 05 17 2002 0 COMPARISON Patient Patient Jones Pat Type P
39. 65750127 v FIGURE Figure 1 1 Figure 1 2 Figure 1 3 Figure 1 4 Figure 2 1 Figure 2 2 Figure 2 3 Figure 2 4 Figure 2 5 Figure 2 6 Figure 2 7 Figure 2 8 Figure 3 1 Figure 3 2 Figure 3 3 Figure 3 4 Figure 3 5 Figure 3 6 Figure 3 7 Figure 3 8 Figure 3 9 Figure 3 10 Figure 3 11 Figure 3 12 Figure 3 13 Figure 3 14 Figure 3 15 Figure 3 16 Figure 3 17 Figure 3 18 Figure 3 19 Figure 3 20 Figure 3 21 Figure 3 22 Figure 3 23 Figure 3 24 Figure 3 25 Figure 3 26 Figure 3 27 Figure 3 28 vi OcuScan RxP Measuring System LIST OF FIGURES NAME PAGE OcuScan RxP Measuring System 2c sch des ER AUR HEX SOEUR Ra Ue 1 1 Mounting Hole cess pex edet ES EXE A A E 1 4 Inserting the Compact Flash Card 22er p RUE RE RE RR 1 5 OcuScan RxP Labels and Icons osorno 1 15 Front Patel rcscrercserenerorenama na Tenani tape EE ARE EAE d REA RN 2 1 Rear Panel 25 oa eger cesses aaa e paia E Eaa E aa a Eaque 2 3 Jua JP aan vi ia 2 4 POOISWICH PP M 2 5 Biometry Probe rsi aeeai coe hare ce bee ees SENA A RR 2 7 Paeliymelrv Probe 25 esses here toD CPP e ap ESO QE PRO RS RES 2 7 Eternal Power SUDDLIY Toa 2 8 Keyboards Displayed on the Touchscreen 22 22 ek RR Ren 2 9 Functional Flowchart cese udo RR dd ds 3 1 Ocuscun RxP Screensaver Display ese capa 3 2 Men Scre n ai onang taks ied ior A Uo da des es 33 System Setup Screen sesiydi reer A AA EXT EEA seats 3 4 Display Menu and Define Report Pop Up WindowWS
40. 750127 OcuScan RxP Measuring System 8065750127 e Alerts user when the Corneal Diameter is possibly too low Default limit is set to 11 mm e Alerts user when the Axial Length AL measured is possibly short Default limit is set to 22 mm e Alerts user when the AL measured is possibly long Default limit is set to 25 mm e Alerts user to the possibility of staphyloma when it detects a long eye that either has poor retina peak standard deviation SD is too large or there is wide variance between the AL of the eyes Default limit for AL is 26 mm for SD is 0 10 mm and 0 33 mm for variance User is advised to perform B Scan Biometry to confirm e Alerts user of larger AL variance between the eyes Default limit is set to 0 33 mm e Alerts user of variability in AL for the same eye Default limit for SD is set to 0 10 mm e Alerts user of a large variance in IOL power between the eyes Default limit is 1 D e Alerts user the possibility of probe not being perpendicular to the eye while some of the measurements were being taken User may want to retake some of the measurements where some of the peaks are not of similar amplitude e Alerts user of possibility of waveform saturation in some of the measurements User may want to reduce the Gain and retake the measurements that appear questionable 13 While Validation is ON tap the Validation Setup button to open the Validation menu Select the desired options and change any of the valu
41. ACE This manual is your guide to the OcuScan RxP Measuring System and considers all options available to the user therefore when reading this manual you only need to pay attention to those options which apply to your specific unit Please read the entire manual carefully before operating the instrument Warnings cautions and notes contained in this manual are important and must be followed A WARNING statement is written to protect individuals from bodily injury A caution statement with the CAUTION heading centered above the text is written to protect the instrument from damage If you have questions or want additional information please contact your local Alcon representative or the Alcon Technical Services Department at Alcon Laboratories Inc 15800 Alton Parkway Irvine California 92618 3818 949 753 1393 FAX 949 753 6614 CAUTION U S Federal Law restricts this device to sale by or on the order of a physician LAST PAGE OF SECTION viii 8065750127 OcuScan RxP Measuring System SECTION ONE GENERAL INFORMATION The OcuScan RxP Measuring System The OcuScan RxP Measuring System is an ophthalmic ultrasound system designed to enhance patient care by providing high quality eye measurements in an easy to use format The system is used for A scan Biometry and Pachymetry applications Biometry consists of measuring the axial length of the eye By applying axial length AL and keratometry K readings i
42. CAL EQUIPMENT CLASSIFIED 95KJ AN R UL 2601 1 CAN CSA C22 2 NO 601 1 685 1029 001 REV PSSS Figure 1 4 OcuScan RxP LABELS AND ICONS Shown here are the assorted labels and icons printed on the console and components 8065750127 OcuScan RxP Measuring System IOL CALCULATION FORMULAS Description of common variables AL Axial length measured K Average diopter power of the cornea K1 K2 2 R Curvature of the cornea in mm 337 5 K in diopters ACD Post operative anterior chamber depth is the value entered in the IOL file The value is supplied by the IOL manufacturer and is used by the BINKHORST II formula except where correction is made to ACD KERATOMETRY On axis 0 K1 28 D to 62 D in diopters On axis 0 K2 28 D to 68 D in diopters On axis 90 K2 2 5 mm to 13 mm radius of curvature in mm K K1 K2 2 K in diopters K 337 5 Kmm Refraction index used 1 3375 BIOMETRY AL Axial length 17 to 40 mm L Axial length BINKHORST II VARIABLES LB2 Axial length corrected for Binkhorst II LB2 AL 0 1984 mm ACDbnk Corrected anterior chamber depth only for the posterior chamber IOL If LB2 26 then ACDbnk ACD LB2 23 45 If LB2 gt 26 then ACDbnk ACD 26 23 45 i e ACDbnk 1 1087 x ACD NOTE When the IOL TYP type is labeled anterior the ACD value does not require correction When the IOL TYP type is labeled posterior the ACD value is correcte
43. IOP 12 00 Adjusted IOP 5 00 I1 pea 645 feu ea 645 4 e 545 EN 645 845 gt o ES Desired Ablation 82 00 Flap Diameter 100 00 Flap Thinkness 160 Target Residual Bed 300 Desired Ablation 50 00 Flap Diameter 130 00 Flap Thinkness 160 Target Residual Bed 300 Flap Achieved Potential Ablation Flap Achieved Potential Ablation c Hn sg B z Pre Op 848 645 645 845 Pre Op 646 845 644 PostFlap 644 643 644 643 1 2 343 PostFlap 644 644 643 PostArblation 644 644 645 644 Si PostArblation 646 512 643 PostOp 848 643 646 643 PostOp 645 644 644 1 2 3 Potential Enhancement Potential Enhancement w E w A p Figure 3 39 PACHYMETRY DATA IN THE PATIENT VIEWER This screen shows the patient pachymetry data displayed on a PC using the Patient Viewer LAST PAGE OF SECTION 3 58 8065750127 OcuScar RxP Measuring System SECTION FOUR CARE AND MAINTENANCE Maintenance Operator maintenance service of the OcuScan RxP Measuring System is limited to that outlined in the OPERATING INSTRUCTIONS and TROUBLESHOOTING sections A problem that persists following setup and troubleshooting should be referred to your local authorized Alcon service representative Alcon s Field Service Representatives are trained and experienced with the OcuScan RxP M
44. L_ IOLPwr SF Exd Lens Data Tap on a row to display the Add data window Average SEM compute Update Clear Lim OK EDIT Row Number 1 LSR K2 AL SPH CYL IOL D 7 ND REM BEL Figure 3 13 LENS CONSTANT UPDATE SCREEN Lens constants can be updated here based upon actual patient data Touching any row of the grid will open the Edit screen or Add screen depending upon whether the row has data to edit or it is a new entry The following parameter ranges are allowed Parameter Range KI 28 D 12 05 mm to 62 D 5 45 mm K2 28 D 12 05 mm to 68 D 4 96 mm AL 15 to 39 mm SPH 15 to 15 D CYL 15 to 15 D V 0 to 30 mm IOL 50 to 50 D When SPH CYL 2 lt 4 or when SPH CYL 2 44 the system will require entry of the V Vertex Distance parameter or verification of the default value of V 12 mm For each line of IOL implant data that does not require entry of the V parameter one SF value is automatically calculated To use the default value of Vertex V 12 mm press the Enter key If a new value is desired delete the default by pressing the Backspace key and typing in the new number 3 20 8065750127 OcuScan RxP Measuring System 8065750127 As data is entered for each case its SF value is calculated and displayed in the SF column If SF is less than or equal to 3 10 or more than or equal to 5 10 it is considered as NULL indicated by the N in the EXCL column and is ex
45. Manufacturer Alcon Laboratories Inc 6201 South Freeway Fort Worth Texas 76134 2099 U S A Produced By Alcon Laboratories Inc 15800 Alton Parkway Irvine California 92618 3818 U S A Telephone 949 753 1393 800 832 7827 FAX 949 753 6614 8065750127 F ASSEMBLY 905 6850 001 E TEXT ONLY OcuScan RxP Measuring System OPERATOR S MANUAL EU Authorized Representative Alcon Laboratories U K Ltd Boundary Way Hemel Hempstead Hertfordshire HP2 7UD England CC Directive 93 42 EEC O 2003 2005 Alcon Inc DATE June 2003 Dec 2003 Jan 2004 Oct 2004 June 2005 Nov 2005 REVISION A B OcuScan RxP Measuring System OcuScan RxP Operator s Manual 8065750127 MANUAL REVISION RECORD ECN NUMBER amp REVISED PAGE NUMBERS ECN 20033093 Initial release of operator s manual ECN 20033945 Updated information for the Patient Viewer tem plate along with other miscellaneous changes Changed pages include i title iii vi 1 2 1 4 1 8 2 4 3 1 3 2 3 38 3 39 3 42 3 48 4 1 5 2 6 1 ECN 20042012 No changes to text clerical change to assembly drawing ECN 20043577 Update EMC statement Changed pages include 1 title viii 1 6 1 22 7 1 7 2 ECN 20050660 Updated manual with new information for instru ment disposal WEEE Changes to pages i ii 1 10 1 14 and 7 1 ECN 20051333 Updated manual with new information for software version 1 12 Chan
46. aca ace ep ii car aree a pe ae Roca tire eet ied d na 2 4 e A o E E E ef sed EE 2 5 Probes and Probe Holdets 2 o cede RR a RU echa aha oce oaov ace Phe n 2 7 External Power SUPPORT quie a V d 2 8 Ke bra MEE Em 2 9 SECTION THREE OPERATING INSTRUCTIONS IO UCI is a A PUTET 3 1 System PONE E A SAR E ae 3 2 E E ate ee a 3 2 de Menu Screen essere S28 gaat Secs loe medie tps dotada Mae betae eed ins 3 3 Usines the Touch e AAA O E oe Oe ae aa 3 3 Syse Sepine A O Peer eer eee 3 4 Patient Records crea 3 9 Probe Check iorri cosa e Pee NE II RU imde Motum b eI ERE 3 11 BIOMETRY cor ore a ein es A E A A ENE ee 3 13 Setting up the Biometry Presets ius Ra knee oemi rpg ORG eae nt RC p a Ok bee oe ees 3 15 plc 3 14 Phakic Eye Velocities an apg A OA E han 2 15 Pa e AA c Fed cain ves E e aed PRAE ee 3 16 A O 3 16 Audio Feedback 3 17 Keratometer Index 3 17 SEU ea ra E an nn lr a To We Se Gea ea Ge 3 18 Pseudo and Phakic IOL Defaults 0 0 0 0 eee eens 3 18 Lens Constants 2 0 0 0 ee eee eee rs 3 18 Lens Constant Update SOPORE s quc eae ata WR Reg a p RC cq cab Gah ApS WE di Dag Ras 3 19 8065750127 iii OcuScan RxP Measuring System SECTION THREE OPERATING INSTRUCTIONS continued PAGE Patient Setup TOF BIOHIGEEY uud et pei pesca deen ied tne taped oe ede gi ci boi pa ie 322 OD Right Bye and OS Lel Ey ss cua duck pd tu asa pi Gg a ae OR ua ere 3 24 K Values Befo
47. aitt icono dolia 3 18 Lens Constant Conversion oooooocccccooocccooccnnnoonccnananononnos 1 23 Lens Constant Update Screen ssssssss 3 19 M E 4 1 Manual MOd8 ooocccccccccccnccnoconccnncnncnnnnccnonnconnnona 2 5 3 14 3 40 Map 1 And 2 iia aa 3 41 3 43 Menu Screen EN 3 3 N New P llent ipie etm idea 3 22 O OD RIGNtEYO irlandes creada 3 24 Operating Instructions eseeeeennnee 3 1 Operators Manual sese 6 1 Optional Ilems roter eainiie 6 1 OS Left Eye nivei ata 3 24 P Pachyrmelry iii 1 1 2 1 3 39 5 2 Pachymetry Patient Setup 3 43 Pachymetry Presets cocinan 3 39 Pachymetry Probe Check sse 3 12 Pachymetry Probe Connector ssesseeees 2 8 P chymelry Scans mural 3 43 Pachymetry Scans In Auto Mode sssss 3 46 Pachymetry Scans In Manual Mode 3 46 Pachymetry Scans In S auto Mode 3 47 Patient Data iii naaa 3 49 nxor LEE 3 23 Patient Information Screen ssssssssss 3 22 Patient Nama ceci aeter e esee bera Deed eds 3 22 Patient Records Screen ssssssssssssssss 3 9 Patient SCD EUR 3 22 Patient Viewer ooooconnonococccnnonococcnncnnononcnnnnncnna na ncnncnnnnn nos 3 49 PO Formate e 3 8 3 9 Phakic Eye Velocities eseeeseeeeess 3 15 A e E 6 1 i em 3 2 Power Cold ect erem
48. an RxP rear panel Plug the biometry probe cable into the BIOMETRY connector on the rear panel then place the probe in the probe holder on the right side of the console with the probe tip pointing upwards Plug the pachymetry probe cable into the PACHYMETRY connector then place the probe in the probe holder on the left side of the console with the probe tip pointing upwards Verify that a paper roll is installed in the printer compartment on the front of the console If not install a new paper roll as detailed in Section Four Care and Maintenance If a Patient Records Compact Flash card has been purchased with the system insert it into the slot on the left side of the console with the insert arrow facing up and pointing towards the slot see Figure 1 3 Place the stylus into the holder on top of the console see Figure 2 1 If you have power supply model PMP130 14 S turn the system ON by pressing the switch on the external power supply to the ON position If you have power supply model PCM 80PS24 the power will turn on when the power cord is plugged into the wall outlet The LED on this model indicates that the power is on OcuScan RxP Measuring System Mounting Holes 4x 51 2 in 61 16 in Figure 1 2 MOUNTING HOLES The system can be mounted to a cart or table using the threaded mounting holes shown in this illustration Use screws with a M5 x 0 8 thread and the appropriate length to extend through the surfa
49. ance to Map 1 4 Tap the Map 1 button to advance to Map 2 Map 2 is the same as Map 1 except that the scan locations may be configured differently 5 Tap the Map 2 button to advance to the Lasik screen The Lasik screen appears as shown in Figure 3 30 It is customized to meet the needs of Lasik surgery with readings arranged for Pre Op Post Flap Post Ablation and Post Op 6 Tap the Lasik button to return to the Single Point screen 03 11 2005 14 33 PACHYMETRY SCAN Patient Field Ranent Settings dc First Name Preset Preset1 Tap this field to NS dotem EUM Single Point Actual enter the Patient 1D Cornea Velocity 1641 Information screen WIW AUTO 400 To 700 OD Right Eye Position Buttons 2 3 4 Valid readings shown on buttons blinking 5 e m m button indicates the sss Jesi Jesi next position for a reading pink button 9 10 Min indicates reading Avg out of range SD Measured IOP A Formula Measured IOP Herndon Adjusted IOP Adjusted IOP E AM Figure 3 28 PACHYMETRY SINGLE POINT SCREEN The Single Point screen allows the user to record multiple scans of a single point on the cornea 8065750127 OcuScan RxP Measuring System Patient Frame Contains Patient information Tap in frame to open the Patient Information Screen Position Buttons Valid readings shown on buttons blinking blank blue button indicates the next position for a reading blink
50. and these will be retained under the current Preset Consult with the IOL manufacturer if you are in doubt concerning which constant to use in your IOL selection 2 Return to the Biometry Scan screen by tapping OK at each screen When OK is pressed at the Biometry Presets screen you will be prompted to save the new settings for that preset tap Yes V or No X NOTE Currently unsaved patient data will be lost if the new settings are saved OcuScan RxP Measuring System PATIENT SETUP FOR BIOMETRY 3 22 Patient information for both Biometry and Pachymetry is entered on the same screen for both procedures if Pachymetry is performed in conjunction with Biometry user enters via Biometry selection If user selected Pachymetry from the Menu screen then a different Patient screen with only Pachymetry related information is displayed see Pachymetry section 1 From the Menu screen tap either the Biometry or Pachymetry button to enter the respective scan screen 2 Tap the Patient frame as shown in Figure 3 14 to enter the Patient Information screen Tap the Patient frame to enter the Patient Information screen peral Technique Immersion y Mode DN Acs I v 1555 1666 1555 AUTO 1 2 3 4 5 6 7 8 s 1 t Figure 3 14 THE PATIENT FRAME Tapping this frame in the Biometry screen opens the patient information screen The Patient Information Screen appears as shown in Figure 3 15 If a patient wa
51. anged by tapping the Setup button Actual is the actual measurement taken with no bias applied Preset Name A descriptive name can be given to each preset Screen Setup Selects the active screen positions for Single Point Map 1 and Map 2 Thickness Range Select the default range from either 100 350 400 700 or 300 1100 Lasik Targets Enter the target values to be displayed on the Lasik Screen PACHYMETRY PRESETS SCREEN This screen allows the userto configure five different presets 3 Tap the Preset down arrow to display the drop down menu Five presets are available and each can be selected by tapping on the number 4 Tap the Name field If desired enter a name for the preset using the keyboard displayed on the screen Confirm the name by tapping OK 8065750127 3 39 OcuScan RxP Measuring System Settings The Settings frame contains selections to set the defaults for Mode Cornea Velocity Screen layout Volume Thickness Range Bias and Lasik Targets Although the Mode Bias and Screen can be changed on the Pachymetry Scan screen the other settings will default to the selection made in this screen and cannot be changed on the scan screen 5 Tap the Mode drop down menu down arrow and select the desired mode The Mode setting has three options Manual Auto or S Auto Super Auto The factory default mode is Auto Manual In this mode the user presses the footswitch to take a measuremen
52. any buttons On the PC ActiveSync will appear reporting the connection and ask if you want to set up a partnership click No then the Next button see Figure 3 31 New Partnership xj Set Up a Partnership Before you can synchronize information between your mobile device and this computer you must set up a partnership between them Would you like to set up a partnership C Yes Set up a partnership so that can synchronize information between my device and this computer ONG e Click No don t want to synchronize information Set up my device as a guest so that can copy or move information between my device and this computer then Next Cancel Help Figure 3 31 The ActiveSync Partnership Screen This screen appears on the PC prior to synchronization with the OcuScan RxP Measuring System 4 In the ActiveSync window click the Explore button locate the Patient data files and copy them to the Patient Files folder on the PC Figure 3 32 shows the sequence of screens you will go through to complete this step 5 Select the required patient files csv then drag and drop them from the storage card to the folder created on the PC Patient Files 8065750127 3 51 Click Explore E 2101 x 43 Microsoft ActiveSync Ele View Tools Help e o g Sync Details Explore Options Stop Guest Connected Information Type Status Double Click Storage Card
53. are automatically activated although Mode and Gain can be manually changed on the Scan screen 5 Tap the Mode drop down menu down arrow and select the desired mode The Mode setting has three options Manual Auto or S Auto Super Auto The factory default is set as Auto Manual In this mode the user unfreezes the system by pressing and releasing the footswitch positions the probe on the eye and looks for a good waveform When a desired waveform is seen the footswitch is pressed and released to save the measurement Software criteria requires a minimum of cornea and retina peak detection to save the reading under Force Freeze condition Force Freeze measurements are shown in smaller font and blue color Auto In this mode press and hold the footswitch align the probe to get the best waveform and release the footswitch If the software criteria for range and amplitude of peaks is met then the system will automatically obtain ten readings If there is difficulty in obtaining a measurement the user can override the software criteria by initiating a force save by pressing and releasing the footswitch within a half second Force Freeze measurements are shown in smaller font and blue color The user should review the peaks and gate locations to decide to retain or delete the Force Freeze measurements S Auto Super Auto mode is similar to Auto mode except that it automatically adjusts the gain and software criteria looks for beam perp
54. at Hour Minute Second anguage Video Mode 80 F Video Mode Service Menu Select LCD Only Entrance to Service or SVGA mode Mode password required to connect to an external monitor mo Operator Name The name of each operator is shown here Tap the field to enter the name of the operator Records Display Menu m Printer Paper Save Patient Format OK 7 a Ga er Esc Exits the system setup without saving changes Records These buttons determine the action of the Print Save button Printer Paper Use these buttons to load printer paper or move it forward or reverse Save Patient Format Selection allows saving patient data in Compact Flash or PC Format Only the selected format will be displayed on Patient Records OK Tapping this button saves changes made to system setup Print Save Button Tapping this button will print a copy of the System Setup screen SYSTEM SETUP SCREEN The System Setup screen enables the user to configure the system as needed This screen is also used to load paper in the internal printer 3 Using the stylus touch the Clinic box a keyboard appears on the screen Using up to 20 characters type the name of your facility then press OK The name of 3 4 your facility appears in the Clinic box 8065750127 OcuScan RxP Measuring System 8065750127 Select the Operator number from the drop down menu then enter nam
55. ata and K values have been entered for the eye Improper footswitch function in Manual or Auto mode Improper connection Check that the footswitch connector is properly plugged into the back panel The system goes through unnecessary screens while sequencing via Next arrow key Settings screen is not configured Configure the Sequence of screens that you normally use in the Settings screen Not able to reposition the gates System not in Gate Edit mode or improper technique in moving gates In frozen mode touch the screen enter Gate Edit mode and tap on Gate Select key until the desired gate is selected In Pachymetry the system does not take measurements Pachymetry probe not properly connected Insert the Pachymetry probe connector Pachymetry measurement in Map or Single point is incorrect Incorrect Bias selection Select proper Bias for either or absolute Bias The Actual selection will display the actual reading with no bias applied System not responding or displays error messages System failure Power system down then power back up On systems 685 0000 502 and above see REF number on label press and hold the standby switch for 7 seconds then release to reset reboot the system If problem persists do not use the system Contact your local Alcon representative Table 5 1 TROUBLESHOOTING CHART continued from previous page 5 2 LAST PAGE OF SECTION
56. ation and Flap Diameter by tapping inside each field PACHYMETRY SCAN Settings 03 11 2005 14 37 Patient First Name Last Name ID WIW Desired Ablation o um Flap Diameter mm 1 2 Preset Preset1 Operator Operator 1 Cornea Velocity 1641 Position Buttons Valid readings shown on buttons blinking button indicates the next position for a reading pink button indicates reading Readings out of range m AUTO Lasik Screen 400 To 700 160 300 Flap Thickness Residual Bed Flap Potential Achieved Ablation Ablated Potential Enhancement Calculations Values are automatically calculated for each of the listed categories Prop I essere LL T Poso Procedure OW d Scans are organized according to the phase of the Lasik procedure Bo Figure 3 30 EN PACHYMETRY LASIK SCREEN The Lasik screen allows the user to organize scans by the four main phases of Lasik surgery 8065750127 3 45 OcuScan RxP Measuring System Pachymetry Scans in Manual Mode In Manual mode the user presses the footswitch to save each measurement The current position blinks indicating the location where the measurement will be saved 7 8 10 11 Ensure that the Pachymetry probe is connected to the rear panel and the Mode button displays Manual Set the Bias and Thickness Range buttons to the desired values The Bias button al
57. behind paper loading door Figure 2 1 FRONT PANEL The front panel contains an LCD touch screen a standby switch a speaker and printer 8065750127 24 OcuScan RxP Measuring System Front Panel Components see Figure 2 1 2 2 LCD Touch Screen and Display User interface to the system is via the built in LCD touch screen Waveforms patient data and functional control keys are shown on the display Standby Switch with LED With power connected there are three modes the unit can be in normal mode screen saver mode and standby mode While in normal mode if the footswitch or touch screen is not activated for 10 minutes the system will go into screen saver mode floating icon If it is still not activated for another 15 minutes then it will go into standby mode blank screen While system is in screen saver mode or normal mode pressing the standby switch sets the system to standby mode While in standby mode pressing the standby switch returns the system to normal mode without going through the boot up sequence While in screen saver mode tapping the touch screen or footswitch returns the system to normal mode On systems 685 0000 502 and above see REF number on label pressing and holding the standby switch for 7 seconds then releasing will reset reboot the system Speaker Used to signal the acquisition of readings A beep is emitted each time a reading is stored In Pachymetry S Auto mode a voice confir
58. ce of the table or cart INSTALLING OPTIONAL SOFTWARE AND UPGRADING SYSTEM SOFTWARE Optional software is available for the OcuScan RxP Measuring System and can be ordered by following the directions in Section Six Accessories and Parts The optional software and system software upgrades are delivered on a Compact Flash card and are installed as follows 1 Insert Compact Flash card containing new software into the slot on the side of the system as shown in Figure 1 3 2 For systems with REF number 685 0000 501 see label behind display panel turn the system power OFF then back ON For systems with REF number 685 0000 502 and above reset the system by pressing and holding the standby switch for 7 seconds The software is automatically installed When upgrading the system software a status bar is displayed showing the progress of the upgrade installation NOTE The Compact Flash card containing the optional software will only work for one upgrade and the same card can be used for storing patient data thereafter It is recommended to re label the card if using it for patient data 1 4 8065750127 OcuScan RxP Measuring System Ridge faces down when inserting card Figure 1 3 INSERTING THE COMPACT FLASH CARD Insert the Compact Flash card as shown in this figure 8065750127 1 5 OcuScan RxP Measuring System NOTES CAUTIONS AND WARNINGS NOTES All data that has been entered or displayed on any screen must be verif
59. cluded from the calculation of the average SF After the data entry the system calculates the following information if the Compute button is pressed Average Value AVR and Standard Deviation of the Mean SEM for each parameter K1 K2 AL SPH CYL and IOL AVR of Surgeon Factor column e New calculated constants A and ACD corresponding with calculated SF value These are displayed below the current constants for the selected lens and the Identifier I U C is changed to C Calculated Number of cases used for calculations as well as the number of exclusions and SEM Note As AVR is calculated the system excludes the cases in which SF is outside the maximum and minimum ranges as determined by the formula SFavg 2 SD If any cases are excluded for this reason X is displayed in the EXCL column The Update button updates lens information for the selected lens in the current Preset only and the lens will be labeled as C for Calculated The Clear button clears data from the Average and SEM rows The OK button returns the system to the Lens Constants screen NOTES Do not select the Compute option unless you have actually entered and verified the appropriate values into the LENS UPDATE screen Before Updating compare the current constants to the calculated constants to ensure that you want to replace the current constants with the calculated ones Pressing the Update button will store the new calculated constants
60. creens 24s cred RYE e 3 47 Pachymetry Scans using the Map Screens ccs sexe end A 3 48 Pachymeiry Scans using the Lasik Screen ic 22e e uu eae an eae geh LATIO e Upon SOR Se 3 48 COPYING PATIENT DATA TO A PERSONAL COMPUTER 0 cece cece renee 3 49 Using a Compact Flash Card Reader to Transfer Patient Data 00 00 000 3 50 Transferring Patient Data to a PC through a USB Connection 0 0 00 eee eee 3 50 Transferring Patient Data to a PC through an Ethernet Network Connection 3 52 Viewing Patient Data ol a PG oiu anas coe UR RATE ted E UR dps ees tar dit d 3 54 8065750127 OcuScan RxP Measuring System SECTION FOUR CARE AND MAINTENANCE Maintenance aca snaps ecg C A eR ERR ACRIOR RC RU ER RA SE AGG aOR OE UC AGRUM RA A IA ARA AR 4 eue M Pr rcc Spans ttnig S e 4 1 Cleaning the Consolen since nate wr eed sce oa eke oie Lucr eh lu ace eka kee eee eas 4 1 Cleaning the Touch Sereen at o Sea pao A Se agin Be Ra h 4 1 Taking Care of the Biometry and Pachymetry Probes cercania e 4 2 installing Paper into e PEEL o oie a fer d 4 4 SECTION FIVE TROUBLESHOOTING OcuScan RxP Troubleshooting Instructions uas ceracees Ges does Wea saad 408 A 5 1 SECTION SIX ACCESSORIES AND PARTS Oc sScan RXP ACCESSES sediento ews 6 1 O cuScan RXP Opti nal HEMS 14 RAR Aad AOR oon McRae AAA RA A 6 1 SECTION SEVEN INDEX Alphabetical Listing ar TOPICS Cta e reor aw A A AAA dell 80
61. ct a new default Gain setting for that preset The allowable range is 40 80 dB with a system default of 64 dB Tap the Target Ametropia drop down box The default for target ametropia is 0 00 The other selections are 0 5 1 0 and Other If Other is selected the acceptable range is 10 to 10 OcuScan RxP Measuring System Phakic Eye Velocities The Phakic Eye Velocities frame allows you to change the ultrasound velocities for the Anterior Chamber AC Lens L and Vitreous V 10 Tap the Age Compensation button to toggle it ON or OFF If Age compensation is enabled the software automatically compensates the velocity of the natural lens based on the age entry of the patient Patient age is entered on the Patient Information screen Age Compensation provides the appropriate ultrasound velocity for the crystalline lens based on age of the patient Velocity V is inversely proportional to the square root of the Density d and the Compressibility c of the medium Compressibility is the fractional decrease in volume when pressure is applied to the medium V 1 dc The greater the age of the patient greater will be the thickness of the lens greater compressibility and density and hence lower the ultrasound velocity 11 To change the AC L or V velocity tap inside the field and enter the new velocity in the dialog box Tap OK to accept the new value The acceptable velocity ranges are as follows AC 1400 2000 with fa
62. ct cornea anterior of lens posterior of lens and retina with a triangular shape simulating the sclera Refer to Section Three Probe Check for a detailed description on how to perform a probe check Carrying Handle J Eye Model Y Flash Card Slot Flash Card Figure 2 3 SIDE PANEL The left side of the OcuScan RxP Measuring System contains the Flash Card slot Compact Flash cards are memory devices that can be used to save patient data or upgrade the system software 8065750127 OcuScan RxP Measuring System Footswitch The footswitch allows hands free initiation of the system control function Footswitch es Figure 2 4 FOOTSWITCH The OcuScan RxP footswitch plugs into the rear panel Biometry Footswitch Functions e Automatic Mode To obtain biometry measurements in automatic mode press and hold the footswitch while aligning the probe on the eye until the desired waveform or trace is obtained It may be necessary to adjust the gain to obtain an acceptable waveform At this point hold the probe steady and release the footswitch to obtain ten automatic measurements If the measurement is not locking possibly due to one of the signal amplitudes not meeting the required criteria pressing and releasing the footswitch within 0 5 seconds will Force Freeze the measurement After ten readings are obtained the gates are automatically placed on the echograph and the measurement is displayed in the reading box
63. ctory default at 1532 m s L 900 2750 with factory default at 1641 m s V 300 3000 with factory default at 1532 m s Acquisition Speed The Acquisition Speed setting has three selections Low Medium and High that determine how fast measurements are acquired 12 Tap the Acquisition drop down menu and select the desire speed Validation Tapping the Validation Setup button displays the Validation Menu shown in Figure 3 10 The user can activate any of the 12 validation points which will display a message if validation is turned ON and the selected criteria is met The measurement in question should be repeated and possibly a second person should confirm it For example If the first validation point for K lt 40 is selected then a pop up asking you to confirm the entry will be displayed if a K value less than 40 is entered To change the criteria for a validation point simply tap in the field then use the on screen keyboard to enter the new value Following is a list of 12 validation points e Alerts user that the K value is possibly too low Default limit is set to 40 D but user can configure as appropriate e Alerts user that the K value is possibly too high Default limit is set to 47 D e Alerts user of larger Kavg variance between eyes Default limit is set to 1 D 1 Jack T Holladay MD MSEE Standardizing Constants For Ultrasonic Biometry Keratometry And Intraocular Lens Power Calculations JCRS 1997 23 1356 1370 3 16 8065
64. d Deviation SD Probe Check Settings Preset Probe Check Operator Operator 1 Cornea Velocity 1641 AUTO 300 To 1100 OD Right Eye 2 3 4 1 _ 5 6 7 8 Ee 9 10 Min 638 Avg 638 SD 1 00 Figure 3 9 PACHYMETRY PROBE CHECK SCREEN This screen is used to verify that the pachymetry probe is functioning properly 8065750127 OcuScan RxP Measuring System BIOMETRY SETTING UP THE BIOMETRY PRESETS The system allows up to five different preset configurations enabling the user to quickly select a particular setup for a patient based on eye type or surgeon preferences The following steps show how to change and save a preset Settings Select desired setting from each drop down menu Each selection is applied to the current preset Sequence From the Menu screen tap the Biometry button to enter the Biometry scan screen Tap anywhere in the Settings frame The Biometry Presets screen appears as shown below in Figure 3 10 Phakic Eye Velocities Changes to the standard phakic eye velocities can Presets y be made here Five presets are available N to be configured as needed ame E Enter Preset name BIOMETRY PRESETS Age compensation Must be set ON to eet CON Name gt CTI Gun Brake EVE EIS 2 enable Age based ettings akic Eye Velocities m s velocity compensation eao El Age Compensation OFF for the natural lens CAC immersion y 8 52 BEN GG BE GC Acquisit
65. d and the IOL power will change 8065750127 OcuScan RxP Measuring System HOLLADAY VARIABLES L Axiallength in mm Lhol Axiallength corrected for HOLLADAY Lhol L 0 200 mm SF Surgeon Factor proper for HOLLADAY formula SF 0 5663 x A 65 60 where A SRK Constant This calculation per default is proposed when parameters are entered in IOL files If the operator modifies SF it is this new coefficient which will be used CAhol Anterior chamber corrected for HOLLADAY Rag R except if R 7 mm then Rag 7 mm AG 12 5 23 45 L i e AG 0 533 x L except if AG 213 5 then AG 13 5 mm ACDH 0 56 Rag Rag AS 4 CAhol ACDH SF Common formulas for BINKHORST II and HOLLADAY R Curvature of the cornea in mm 337 5 K with K in diopters LC Axial length corrected CA Post operative anterior chamber IOLam IOL power for ametropia For BINKHORST LC LB2 CA ACD for anterior chamber or ACDbnk for posterior chamber For HOLLADAY LC Lhol CA CAhol Formula which gives the IOL value depending on the desired target ametropia or refraction Tam IOLam f Tam if Tam 0 then IOLam IOLem emmetropic 1336 1 336R 0 3333LC 0 001Tam 16 032R 4LC LC x R TOL ait A A LC CA 1 336R 0 3333CA 0 001Tam 16 032R 4CA CA x R Formula which gives the refraction value depending on the desired IOLam Tam f IOLam 1336 1 336R 0 3333LC IOLam LC
66. ditional review by the user to ensure validity Biometry Scans in Super Automatic S Auto Mode 8065750127 S Auto mode is similar to Auto mode except that it automatically adjusts the Gain to get the peaks high enough for auto lock and at the same time prevents saturation It also checks that the probe is positioned perpendicular to the eye In S Auto mode live axial length is not displayed and measurements cannot be captured using the force freeze feature In addition S Auto works only for phakic eyes If there are problems acquiring measurements in S Auto mode then the user should try auto or manual modes OcuScan RxP Measuring System Biometry Details Screen 17 Press the Next button right arrow on the Biometry Scan screen to advance to the next screen selected in the Settings sequence see Setting up the Biometry Presets After acquiring eye scans The Biometry Details screen in Figure 3 22 shows detailed measurement data for all 10 readings of the right and the left eye The data consists of Axial Length Anterior Chamber Lens and Vitreous The Average reading and Standard Deviation for each of the above sections is also displayed If the data does not exist for one of the eyes then the data for that eye remains blank The user may delete unwanted measurements while in the Detail screen Tapping an entry will select measurements in that row Pressing the Delete key deletes the entry and the system will automatically reca
67. e sese 6 1 UM 2 2 3 3 6 1 System Power up essen 3 2 System Reset sss enne 3 2 T Target Ametropia oooonccccnnncconnocncnonnccrnnnnnnnnnccnnnnns 3 14 3 36 Regole 3 14 Temperatura ode 1 14 Thickness RanQl occcccoccnconcccnnccnononcnnconcnancnncancnnnns 3 42 3 46 Mime anida 3 5 TOUGH Screen eee rere ta ne ni ces 21 33 Troubleshooting Instructions seeren 5 1 U Underwriter s Laboratories eeeeeeee 1 11 Universal Precautions eeeeeeeeeeeee 1 11 Upgrading System Software sss 1 4 Uploaded Patient Data see 3 10 USB Connection essen 3 50 USB Connector usos 2 3 USB Driver patient Viewer CD sse 6 1 V NaldalO hausa ders Lene tee Eis Udo tcu LER 3 16 VGA Video Output Connector seeeess 2 3 Video Mode sssssssssssseseeseneene nennen 3 5 Mice ada aid eiii 3 34 W Ene ii R 1 6 Warnane TEE 1 18 jm ceded 1 14 White To White oooooccccccncococcccccconononcnnncnannncncnonnnnoncnnnnnnns 3 25 Z ZOOM BUWOM pirmas t 3 31 LAST PAGE OF SECTION 7 2 8065750127
68. e according to the EMC information provided in Tables 1 1 through 1 3 Portable and mobile RF communications equipment can affect this medical electrical equipment Use of accessories and cables other than those provided may result in increased emissions or decreased immunity of the system The OcuScan RxP Measuring System is intended for use in the electromagnetic environment specified in Tables 1 1 and 1 2 The customer or the user of the OcuScan RxP Measuring System should assure that it is used in such an environment Emissions Test Table 1 1 OcuScan RxP Measuring System Electromagnetic Emissions Compliance Electromagnetic Environment Guidance RF emissions CISPR 11 Group 1 The OcuScan RxP Measuring System uses RF energy only for its internal function Therefore RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class B Harmonic emissions IEC 61000 3 2 Class A Voltage fluctuations flicker emissions IEC 61000 3 3 Immunity Test Complies Table 1 2 The OcuScan RxP Measuring System is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Electromagnetic Immunity IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance
69. e exe file that was downloaded 5 Follow the screen prompts e Copy the PatientViewer exe and ZedGraph dll file from the OcuScan RxP CD ROM to the PC preferably in the folder where the patient files are stored 8065750127 3 49 OcuScan RxP Measuring System There are three ways of transferring patient data to a personal computer PC Using a Compact Flash card reader connected to the PC Connecting the OcuScan RxP Measuring System directly to a PC through the USB port Connecting the OcuScan RxP Measuring System to a local network through the ethernet port Using a Compact Flash Card Reader to Transfer Patient Data 1 Connect a Compact Flash card reader to your PC If your computer is not already equipped with the card reader you may purchase one at a computer store Since most of these readers use a USB connection your PC must be equipped with a USB port Remove the Compact Flash card from the OcuScan RxP Measuring System and insert it into the card reader connected to the PC The Compact Flash card should automatically mount and be accessible through My Computer or Windows Explorer Copy the patient files from the Compact Flash card to the folder Patient Files you created on the PC hard drive Patient files are assigned names from the patient ID numbers entered on the OcuScan RxP Transferring Patient Data to a PC through a USB Connection Hardware Requirements available USB port on PC and an A to
70. e Silicon oil in the Vitreous If the velocity is changed for this patient it will return to the default value when a new patient is entered K1 and K2 Keratometry values are displayed in diopters The acceptable range for K1 is 28 D 12 05 mm to 62 D 5 45 mm while K2 is 28 D 12 05 mm to 68 D 4 96 mm Avg K The average K reading is displayed in diopters and is automatically recalculated if K1 or K2 changes Al and A2 Meridian values are displayed in degrees The acceptable range is 0 360 degrees NOTE Enter flat K and A in K1 and A1 entry fields and steep K and A in K2 and A2 entry fields respectively K Adjust for Post Op Rx Myope only Tapping the K Adjust button opens a dialog box that enables the user to calculate an adjusted K value based on the patient s clinical history This K adjustment may be necessary for patients who have had Refractive surgery and are now undergoing a Biometry examination If Haigis option is installed then KHaigis will be also displayed along with K Adjust KHaigis is used for Haigis power calculation 8065750127 OcuScan RxP Measuring System 8065750127 White To White This measurement can be made using a commercially available cornea gauge The acceptable range is 9 0 mm to 15 0 mm If this measurement is entered in the Patient screen it will be saved along with rest of the patient information for reference 8 Select the appropriate setting and values for each eye according
71. e shown in pink Measurements in between are shown in black It is recommended to review the peaks and if necessary edit the gates as explained previously in steps 9 through 13 As the gates are adjusted in the Edit Gates mode the readings may change color A single reading can be deleted by touching the reading to select it then pressing the Delete trash button for less than one second All readings can be deleted by pressing the Delete button for one second A deleted reading can be refilled by scanning the patient s eye again The Running state can be brought into Frozen state by tapping on the echogram window The Running state can be re entered by pressing and releasing the footswitch 8065750127 OcuScan RxP Measuring System Forced Freeze Capture If it is difficult to take Auto readings the user can force the capture by pressing and releasing the footswitch within a half second period This capture will take place if the system is able to identify at least the cornea and retina peaks and readings will be displayed in smaller fonts and blue color If all peaks were detected but some have less than normal amplitude then the measurements will be displayed If one of the peaks was not found or if peaks were outside the normal software range then the system will display 0 00 in blue color and gates at default locations until the user manually adjusts the gate locations The measurements with smaller fonts and blue color require ad
72. e the distal tip of the probe in a 0 5 solution of sodium hypochlorite 5 000 ppm available chlorine reference the Dilution Guide below for 5 minutes as follows o Pachymetry Probe immerse the clear conically shaped tip at distal end o Biometry Probe immerse distal end up to 15mm Immediately after immersion remove excess hypochlorite solution with a clean cloth and rinse the probe tip thoroughly with flowing distilled water to ensure residual solution has been removed Dry with a soft clean cloth To inactivate Unconventional Infectious Agents such as prions believed to cause Transmissible Spongiform Encephalopathy TSE the World Health Organization WHO recommends Immerse the distal tip of the probe in a 2 solution of sodium hypochlorite 20 000 ppm available chlorine reference the Dilution Guide below for 60 minutes as follows o Pachymetry Probe immerse the clear conically shaped tip at distal end o Biometry Probe immerse distal end up to 15mm Immediately after immersion remove excess hypochlorite solution with a clean cloth rinse the probe tip thoroughly with flowing distilled water to ensure residual solution has been removed Dry with a soft clean cloth Reference WHO CDS CSR APH 2000 3 WHO Infection Control Guidelines for TSEs Drying Use a soft clean cloth to dry probe Maintenance Inspection amp Testing Inspect probe tip to ensure it is visibly clean and dry
73. e trace reading or average AL entry on the IOL Calculations screen The AL and AC average values are brought forward from the scan screen The user may also manually enter the AC and AL values along with K1 and K2 to perform IOL power calculations 3 35 OcuScan RxP Measuring System Initially the screen will show factory defaults for lens and formula in each of the three columns As new selections are made they will be retained until it is changed again 19 In the IOL Calculation screen enter or change measurement information as necessary for AC AL K1 K2 and AVG K Tapping inside each field will open a window that allows new entries NOTE Changing the AC and AL entries will result in the current unsaved patient data being overwritten and all measurements for the eye being deleted 20 Tap the Target Ametropia drop down menu and select a value within the range of 10 to 10 The default for target ametropia is 0 00 The user has the choice to type in his own value for any particular patient but for the next selected patient it will default back to the configuration selected in the Settings screen 2 Select the desired IOL and formula combinations from the options available in the associated drop down menus The ACD A or SF for the selected IOL is displayed Using the K value and Axial Length value the system software calculates and displays lens power and refraction based on formula lens selection and target ametropia N
74. easurements Statistical analysis of Ultrasound Power Measurements per FDA 510 k Diagnostic Ultrasound Guidance Probe Ly X MIX 10 MHz Biometry O 0221 20 MHz Pachymetry probe G I DS Lu is the derated spatial peak temporal average intensity in mW cm milliwatts per square centimeter MI is the Mechanical Index X stands for upper output parameter statistical limits 2 IEC 1157 Acoustic Output Declaration Exemption The OcuScan RxP Measuring System meets the three exemption conditions specified by IEC 1157 as follows e The peak negative acoustic pressure does not exceed 1 MPa e The output beam intensity does not exceed 20 mW cm e The spatial peak temporal average intensity does not exceed 100 mW cn The averages of the measurements conducted per IEC 1157 of several samples of the 10 MHz Biometry and 20 MHz Pachymetry probes were as follows Probe Biometry Pachymetry 10MHz 20MHz Peak negative acoustic pressure MPa 0 69 0 54 Output beam intensity mW cm 0 03 0 09 Spatial peak temporal average intensity mW cm 0 15 0 57 8065750127 OcuScan RxP Measuring System PRODUCT SERVICE For product service please contact Alcon s Technical Services Department at the number provided below Operators experiencing problems with the system should refer to the Operating Instructions and Troubleshooting sections of this manual A problem which persists should be referred to the Alcon Techn
75. easuring System to provide the highest quality of workmanship possible For warranty information and or service arrangements contact your local Alcon representative CAUTION Do not clean console and accessories with solvents or abrasives irreparable damage will result Cleaning solutions should be applied to the towel rather than the surface of the console or touch screen to avoid fluid ingress Storage Whenever system is not in service it should be covered with its dust cover The dust cover protects the console and monitor from airborne particles and also offers protection against accidental spills Cleaning the Console To clean the console first turn system power OFF and disconnect the power cord from the power source The console may be cleaned with a soft non abrasive cloth towel and a solution of mild soap and water Apply the solution to the towel rather than the console Cleaning the Touch Screen The touch screen may be cleaned with a soft non abrasive cloth towel and any commercially available window cleaner Apply the cleaner to the towel rather than the touch screen 8065750127 4 1 OcuScan RxP Measuring System Taking Care of the Biometry and Pachymetry Probes Follow the guidelines in Table 4 1 to ensure proper care and disinfection of the probes WARNING Do not use this product on eyes when corneal integrity is compromised by infection or trauma CAUTION The Biometry and Pachymetry probes are fragile
76. ed then only files saved in Compact Flash format are displayed The following actions are available by tapping the associated buttons on the patient records screen e Select Loads the selected patient record i e that patient becomes the current patient Refer to Uploaded Patient Data for additional information e Esc Exits the patient records screen without loading a patient Delete Deletes the selected records e Refresh Updates the Patient table This action is required when a different Flash card is inserted Ident Sorts the records by identification number Last Name Sorts the records by last name First Name Sorts the records by first name NOTE When patient data is retrieved from storage it displays only the patient data and measurements IOL power calculations will depend on current selection of IOL s formulas and Target ametropia To select a patient tap the desired patient entry with the stylus and it will be highlighted To add new patients refer to Patient Setup for Biometry and Pachymetry Figure 3 7 PATIENT RECORDS SCREEN Tappingthe Patient Records button onthe Ident J Last Name First Name main menu displays this screen The user 12345 Doe Jane B can select sort remove patient records 5023951563 Jones um 674169538 Thompson or refresh the listing from here TA a The Patient Records screen only displays patient records saved in the currently selected Patient Format
77. endicularity 6 Tap the Technique drop down menu and select the desired technique Immersion or Contact The default mode is Contact Contact In the Contact technique readings are obtained by placing the biometry probe directly on the patient s cornea 8065750127 OcuScan RxP Measuring System Immersion In the Immersion technique an immersion shell containing the probe is placed on the patient s eye and filled with solution between the probe and the cornea see Figure 3 11 Since the probe is not touching the cornea there is an offset on the display between the peak from the probe tip and the peak from the cornea 1 5 to 9 8 mm for auto trigger Immersion E Dan Emm n A Biometry Probe Figure 3 11 IMMERSION TECHNIQUE The probe tip must be located between 1 5 to 9 8 mm from the cornea in order for the system to automatically lock NOTE In Biometry Immersion mode the probe tip must be between 1 5 mm and 9 8 mm distant from the cornea in order for the system to automatically lock and freeze In Immersion mode the software criteria looks for C1 anterior cornea and C2 posterior cornea All other criteria for amplitude threshold and peak locations are the same as for the contact modes Tap the Volume drop down menu and select the volume of audible feedback The selections are OFF LOW MEDIUM and HIGH The system default is low Tap the Gain field A window opens that allows you to sele
78. ent Name and ID A patient ID is required to save patient data Select the desired Preset and Operator These were setup in the previous steps Enter the patient data for each eye Tap the arrow button to return to the Biometry Scan 1 2 8065750127 OcuScan RxP Measuring System INSTALLATION INSTRUCTIONS The OcuScan RxP Measuring System is shipped in damage resistant cardboard crates The components must be removed from the crates set on a secure work surface and assembled as described below Be sure to make cable connections exactly as instructed NOTE Four threaded holes are provided on the bottom side of the console to attach the system to a cart or table if desired Refer to Figure 1 2 for layout and dimensions of the hole pattern 1 8065750127 From the external power supply unit plug the 24 VDC power input cable connector into the OcuScan RxP rear panel see Figure 2 2 From the external power supply unit plug the power cord into a 110 120 VAC or 200 240 VAC power source The power supply is self adjusting and will adapt automatically to either power source NOTE The power cord used to connect the power supply to the wall outlet is shipped with systems for use in the U S A and Canada only For other countries a power cord with appropriate ratings and national safety agency approval must be used Set the footswitch on the floor and plug its cable connector into the footswitch mini din connector on the OcuSc
79. es as necessary Tap Save to save the changes for that Preset or Esc to exit without saving 14 Tap the Validation ON OFF button to toggle the selection for the desired state ON or OFF Audio Feedback When Audio Feedback is on the system emits a beeping sound that increases in speed as the quality of the echogram during acquisition improves Quality of acquisition will improve as all the peaks needed to obtain the axial length increase in amplitude but at the same time are not saturated Optimum signal condition would result when probe is held perpendicular to the eye with appropriate gain level that does not saturate Tapping this button toggles Audio Feedback ON or OFF Keratometer Index This entry is used to accommodate the various keratometers that may be used in acquiring the patient s K values The acceptable range is 1 3315 to 1 3380 The keratometer index should be listed in the keratometer s user manual To change the value tap on the screen to display the edit window This keratometer index entry will only be used for Haigis formula displayed only when Haigis option is installed All other formulas expect K values to originate from 1 3375 and therefore the index is fixed at 1 3375 for those formulas 3 18 OcuScan RxP Measuring System Sequence The Sequence section allows you to set the sequence of screens that are displayed when advancing through the biometry screens The selections that are enabled blue will be dis
80. es for up to five operators To enter a name touch the text box next to Default Operator and a keyboard appears on the screen Using up to 20 characters type the name then press OK Press the Default Operator arrow until the desired number 1 to 5 is reached In the Date field select the Format you desire to have the date displayed in from the following list then select the current Day Month and Year e MON DD YYYY the month is shown alphabetically JAN FEB etc the day and year numerically e DD MON YYYY the day is shown numerically the month alphabetically and the year numerically e MM DD YYYY the month day and year are shown numerically e DD MMY YYYY the day month and year are shown numerically In the Time field select the Format you desire to have the time displayed in then select the current Hour Minute and Second In the Language field select the language you desire on the information screens The Video Mode field contains two selections in the drop down menu LCD Only or SVGA Use the SVGA selection to enable the output to an external video monitor in addition to the LCD If an external SVGA monitor is not used it is recommended to select LCD only mode In the Display Brightness field adjust the optimum video brightness level for the room environment 3 5 OcuScan RxP Measuring System Z The Records field contains two buttons that set the action of the Print Save button that is displayed in
81. es y Cancel Figure 3 34 SAVING PATIENT FILES TO THE PC 5 Select All Files from the Save as type pull down menu and change the patient file extension from htm to csv in the File name box 8065750127 3 53 OcuScan RxP Measuring System Viewing Patient Data on a PC Patient data files that are saved in the PC Format and copied to a PC can be viewed using the Patient viewer template 1 Open the Patient Viewer by double clicking the PatientViewer exe file The patient viewer will appear as shown in Figure 3 35 10 Alcon Patient Files l l System Settings Patient Name Patient ID Clinic Operator Preset Browse First Name Date Time Figure 3 35 THE PATIENT VIEWER This illustration shows the opening screen of the Patient Viewer 2 Click on the browse button and navigate to the location where the folder containing all patient files saved in PC format 3 Click on the folder and select the OK button 4 The patient data files are now displayed in the middle of the screen as shown in Figure 3 36 Each file shows the patient ID Last Name First Name and the Date Time the file was last modified 3 54 8065750127 OcuScan RxP Measuring System Patient Files Biometry Pachymetry Patient Name Clinic Browse Figure 3 36 Wells Sam JAPatient Files ID 04 23 05 10 24 05 System Settings Last Name Menezes D
82. essassacesciseasceuereelasteatiiens ULTRAB 054 service Manual T 8065750242 8065750127 6 1 6 2 THIS PAGE INTENTIONALLY BLANK LAST PAGE OF SECTION OcuScan RxP Measuring System 8065750127 OcuScan RxP Measuring System SECTION SEVEN INDEX A E POS COM ec reiecit E 1 1 Editing The Gate Positions 3 30 AG WE occupe INS 3 24 Edit Gates Screen sess 3 31 ACCOSSOLIBS iraran o oto etel see eee retenue 6 1 Electrical Characteristics sesseeeeesss 1 14 Accessory Equipment rennen 1 11 Electromagnetic Emissions eeee 1 8 Acoustic Output Declaration Exemption 1 12 Electromagnetic Immunity sseeen 1 8 Acoustic Output Measurements sees 1 12 EMC Statement uma 1 7 Acquisition Speed etre ted ie 3 16 Environmental Issues ee 1 11 Adjusted I oie ete oh ipods 3 25 Environmental Requirements eeeeess 1 14 Age Compensation 3 16 Ethernet Connector ssssseeeeen 2 3 Angled Pachymetry Probe eeeee 6 1 Ethernet Network Connection sessss 3 52 Anterior Chamber o irri see tree ro sep restent 3 34 Eye Models eom erro id 2 4 AMO caa eet drin 3 14 3 27 3 40 Automatic Mode ssssssssseneeeeneens 2 5 F Auto Modesa a i aE 5 1 Flash Card Slot 2 4 Average Reading
83. gates can be determined then that particular reading will be displayed as 0 00 until the user edits the gates manually This is accomplished in the Edit Gates state When each gate is moved the system automatically recalculates the AL Axial Length AC Anterior Chamber L Lens and V Vitreous for this scan The SD Standard Deviation and Avg Average values are also recalculated as the new AL is compared to the other nine readings 8065750127 OcuScan RxP Measuring System 9 Tap on the echogram window to enter the Edit Gates state The system displays the Edit Gates screen as shown in Figure 3 21 In Gate Edit mode no gate is selected until the Gate Select button is pressed Tapping the Gate select button selects the default gate lt Settings Name Preset Preseti ID Operator Operator 1 51 4 Type Phakic Technique Contact y K1 AC Le V Mode Original position of gate am Tea dam CERE ar Reposition selected gate by touching screen at desired location used for course adjustments 8065750127 est Axial length FROZEN AC L and V readings are automatically recalculated as the gate is moved SD and Avg values are recalculated GATE as necessary GATE p SELECT neta Accepts changes and returns to scan screen Selects the next gate Moves selected 3 gate left or right Zooms inon used for fine the selected Discards changes adjustments gate and
84. ges made to over 90 of manual Registered in the U S Patent and Trademark Office Windows is a Reg TM of Microsoft Corporation ActiveSync is a Reg TM of Microsoft Corporation 8065750127 OcuScan RxP Measuring System TABLE OF CONTENTS SECTION ONE GENERAL INFORMATION PAGE The OcuScan EXP Measuring System idad 1 1 UIC Start onset red rt ad DIM PI CUN ad aA E tod p Installation Instr cti ns our e ta REX ex 9 REN G4 ee ad E E EU 1 3 Installing Optional Software and Updating System Software 0 0 0 0 cee eee ee oo 1 4 Notes Cautions and Warnings veas x ep PR e AI Rr a 1 6 EMC Statement ette rta ere bI Edu a lt a ias 1 7 Universal Precautions sue dye A wes Pela SI bale a ete eua Poe E 1 11 Underwriters Laboratories c eus dado EIU P Iud eS sd ee 1 11 Accessory Equipment uus qr PE RACE rp oy er EEA WR E EE PEE dk CE de Ras 1 11 Environmental isSu s 2 5 a ad dt id 1 11 User Information Environmental Consideration nases oaase eneee eee o 1 11 SIA a o AAA nn rg VES 1 12 Product SETVICES iia A a Rd gs 1 13 Pi A nare a e a O Cane ip dr tapas 1 13 TOL Calculation Formulas nina ERE P RV A REM EY EY gs 1 16 SECTION TWO DESCRIPTION General DeSSCHDUOD eos err ii hee ER pi db iuc R E ERE UMP e 2 1 SN PS Un Baha ese a eeaunenans aubiere qui tenet 2 1 Rear Panels ue euo ec EPOR nee auch a aes acuti deba ia 2 3 IEEE Oz 25 OU o PCPCT 2 4 Eye Model e cardi
85. gure 3 37 Figure 3 38 Figure 3 39 Figure 4 1 TABLE Table 1 1 Table 1 2 Table 1 3 Table 1 4 Table 1 5 Table 4 1 Table 5 1 8065750127 LIST OF FIGURES continued NAME PAGE Pachymetry Map Lore erosiones 3 45 Pachymetry Lasik SCIGgl escasa rd de 3 45 TheActivesyne Partnership crepas ion 3 51 Accessing Patient Files Through a USB Connection 3 52 Accessing Patient Files Through a Network o oooooooomomo o 3 53 Saving Patient Files to the PC ese sous a RES RR REA REN RES 3 53 The Patient VIEWER cosa eet RR FECE R RET RA 3 54 Patient Viewer with Patient Data i2 sese ek EE CERRAR 3 55 System Settings in the Patient VIBWBE osse rr eg E sn RX CAR 3 56 Biometry Data in the Patient Viewer 0 cece eee eee ee 3 57 Pachymetry Data in the Patient VIeWer e usc eer tirada 3 58 Printer Paper Installation 1i uoa srt radar 4 4 LIST OF TABLES NAME PAGE Electromagnetic Emissions tc Ae a RE CC 1 8 Electromasnetie MIDI a a ANA 1 8 Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the OcuScan RxP Measuring System 1 10 OcuScan RxP System Specifications s iussus Races e e RC Ren RR Rn 1 14 Lens Constant Conversi n Table vs cia pre tiU V axem SR Rp 1 25 Decontamination of Biometry and Pachymetry Probes 4 3 Troubleshooting Chart 1 ugiousdores xo O nee eae Rt e 5 1 vii OcuScan RxP Measuring System PREF
86. h of the current scan and the readings Tapping anywhere inside the various frames and windows on this screen allows you to change settings and data related to that frame The Biometry Screen starts in the Frozen state with the word Frozen being displayed in the Graph window The system does not emit ultrasound in the Frozen state During the Frozen state the gain can be changed measurements reviewed and gates edited 3 27 OcuScan RxP Measuring System The user can transition to the Running state by pressing and releasing the footswitch During the Running state ultrasound is emitted continuously and the corresponding echogram is shown on the screen Biometry Measurements in Manual Mode In this mode the user unfreezes the system positions the probe on the eye and looks for a good waveform echogram When a desired waveform is displayed the footswitch is depressed to save the measurement Software criteria requires a minimum of cornea and retina peak detection to save the reading 2 In the Settings frame ensure that the Contact technique is selected If not tap the Settings frame and select Contact mode For further information on technique refer to Setting up the Biometry Presets 3 Select Manual mode by tapping the Mode button until Manual appears on the button 4 Dip the biometry probe into water and place it on the eye model as shown in Figure 3 18 Biometry a Probe Figure 3 18 USING THE EYE MODEL
87. hakic ID 3225644897 Target Ametropia 0 50 1st 2nd i o MA60BM P MA60BM A 118 90 118 90 ACD 5 20 5 20 SF 1 45 1 45 EMMETROPIA COMPARISON CHART BINKHORST II HAIGIS HOFFER Q HOLLADAY SRK I SRK T BINKHORST II HAIGIS HOFFER Q HOLLADAY SRK4I SRK T IOL selections from IOL Calculation screen Avg K 42 75 Avg AL 23 60 3rd MASOBM P 118 90 Tapping the Formula Config button displays the Formula Configuration window shown below IOL formulas and resulting calculations Haigis formula is grayed out if option is not installed This window gives the user the option of replacing the default comparison chart with a set of three IOL calculation charts all calculated using the formula Axial Length lt 20 00 Formula Configuration Formula BINKHORST I1 E4 selected for the axial length 20 00 825 07 range specified The example below shows the Configured z IOL Calculation screen for an axial length less than 20 mm Fe CONFIGURED IOL CALCULATION Patient Name Type Phakic iD Target Ametropla 0 00 BINKHORST II ist 2nd 101 SA60D3 IOL SA60D3 ACD 6 02 ACD 5 02 Emmetropla IOL Power Emmetropia IOL Power Refraction Refraction RI IOL SA60D3 ACD 6 02 Emmetropia IOL Power Refraction OcuScan RxP Measuring System COMPARISON SCREEN This screen shows the calculated IOL power using each of the five formulas for three different lenses that were
88. he ox Figure 3 10 THE BIOMETRY PRESETS SCREEN This screen allows the user to configure five Tapping the Validation Setup validation pop up right The user can activate any mk CE Esc of the 12 validation points which Ladle 47 00 will display a message if JM Ditrerence in average K between the eyes is gt 1 00 validation is turned ON and the Wi White to White Corneal Diameter is 11 00 selected criteria is met M Ais LET AL is gt and poor retinal spike or 80 is gt EJ or AL ditterence between eyes gt jo 33 Wl AL ditterence between eyes gt osa L SEE 00 IOL power between the eyes gt joo robe not perpendicular Wi saturated wavetorms different presets to select from when preparing for ese Save a biometry scan 8065750127 3 13 3 14 OcuScan RxP Measuring System 3 Tapthe Preset down arrow to display the drop down menu Five presets are available and each can be selected by tapping on the number 4 Tap the Name field If desired enter a name for the preset using the keyboard displayed on the screen Confirm the name by tapping OK Settings The Settings frame contains selections to set the defaults for Mode Technique Volume Gain and Target Ametropia The user can also select Audio Feedback Age Compensation Velocities for phakic eye Acquisition Speed and Validation When a new patient is initiated in the patient screen the defaults from the selected Setting
89. here C 0 C values according to the measured axial length If L 20 mm then C 3 If 20 L 21 then C 2 2 If 21 L 22 thenC 1 If 22 lt L lt 24 5 then C 0 If L gt 24 5 mm then C 0 5 Ametropia values with P Emmetropia power I Desired IOL power Rf Refraction factor Tam Target Ametropia Refraction f I Tam P I Rf where Rf 1 25 if P gt 14 Rf 1if P lt 14 IOL f Tam I P Tam x Rf where Rf 1 25 if P gt 14 Rf 1 if P lt 14 OcuScan RxP Measuring System SRK T FORMULAS L Measured Axial length mm Lcor Corrected axial length mm Rcor Corneal Radius of curvature mm K Average K D crwdest 2 Computed corneal width mm ACDT ACD Constant from the A Constant ACDest Estimated postoperative ACD for patient Retinal thickness Rethick 2 0 65696 0 02029 x L Lcor Lif L lt 24 2 Lcor 3 446 1 716 x L 0 0237 x L2 if L gt 24 2 Recor 337 5 K with K in diopters crwdest 5 41 0 58412 x Lcor 0 098 x K SqrootR1 Rcor crwdest 4 if SqrootR1 0 then SqrootR1 0 Hest Rcor SqrootR1 ACDT 0 62467 x A 68 747 where A SRK Constant ACDest Hest ACDT 3 336 na 1 336 2 20 3333 C3 L rethick 0 97971 x L 0 65696 C4 C3 ACDest C5 na x Rcor C2 x ACDest C6 na x Rcor C2 x C3 C8 12 x C6 C3 x Rcor V 12 vertex distance lens cornea C9 12 x C5 ACDest x
90. his button prior to Drusus d Kb PATIENT INFORMATION entering new patient information new pateni New Patient Patient Name Fara Biometry Preset Iddvb ss lt i Patient ID i ee 24 Pachymetry Preset Patient List Patient List Displays the Patient p i cite Operator 1 F List eat OD Right Eye OS Left Eye currently selected vee E format PC or Compact Flash Z15232 CEN 191532 OD Right Eye panci Flat Meridian Flat K1 YB Flat Meridian OS Left Eye AL Adjustable parameters Steep K2 Steep Meridian Steep K2 YB Steep Meridian for each patient The pombe D l AE K Adjust button opens MAN OMA E K Adjust For Post Op Rx Myope only K Adjust For Post Op Rx Myope only calculated white To White EI mm white To White az mm Save To lOLCALC SAVE Button T Print Save Button o IOLCALC i Tapping this button saves the Tap this button to go to Tapping this button eek L u ee T the IOL Calculation Screen o oo screen i i selected in the the System Settings screen system setup Figure 3 15 THE PATIENT INFORMATION SCREEN New patients can be entered here or current patient information changed 5 Enter the last name of the patient by tapping the appropriate letters on the keyboard displayed on the screen then tap OK to accept the name 6 Repeat steps 4 and 5 for the first name the Patient ID and Age fields If the Age field is grayed out Age Compensation is turned off and can be turned
91. his screen allows the user to configure which positions will be active during acquisition 8065750127 3 41 3 42 OcuScan RxP Measuring System Individual buttons may be deleted set inactive from an existing map When a button is deleted the remaining buttons are reordered so that the numbers show the new scanning sequence 9 10 LL 12 IS 14 15 16 Me Press the Delete button to clear the current button positions Select the buttons that you want available during acquisition in the desired sequence As each button is selected a number appears indicating it is active and its order in the scanning sequence Press OK to save the changes if desired Tap the Volume drop down menu and select the default volume level for this preset Tap the Audio Feedback button to toggle the feature ON or OFF Audio Feedback is a beep based feedback signal that increases in speed as the probe approaches perpendicularity Tap the Thickness Range button to set the default range The three choices are 100 to 350 400 to 700 or 300 to 1100 in um The selection made here will be displayed as the default on the Pachymetry Scan screen Tap the Bias drop down menu and select the default bias type for this preset There are three options available actual no bias applied percentage and absolute Percentage range 0 to 300 and absolute bias range 999 to 999 um values can be changed by tapping
92. iagnostic examinations addressing cataract and refractive surgery needs The standard system consists of a main console a footswitch an external power supply and a biometry probe Optional pachymetry software can be installed along with a pachymetry probe that will enable the system to be used for taking corneal thickness measurements An optional compact flash card is used to save patient records The standard viewing display touch screen is an 800 x 600 SVGA LCD Also available to the user is an external SVGA output port that can be used to connect an external SVGA monitor A built in thermal text printer is used to provide hard copies of screens and reports An external power supply provides power for the console operation Front Panel The 800 x 600 SVGA LCD with touch screen is on the console front panel see Figure 2 1 Beneath the LCD display is an internal thermal printer compartment To the left of the printer is the speaker and to the right is the standby switch with an LED that indicates standby mode when OFF Probe holders are located on each side of the front panel NOTE It is recommended to place probes in the holders in the position shown in Figure 2 1 The probe tips should be pointing up 4 Removeable Stylus inserted in holder Pachymetry Probe Biometry Probe Be LCD Touch Screen and Display Speaker Standby Switch Compact Flash Card Slot shown with card installed Internal Printer
93. ical Services Department or your local authorized service representative For optimum performance it is the user s responsibility to schedule preventive maintenance service on the system and its accessories one time each year Alcon s Field Service Engineers are trained and equipped to provide the highest quality of workmanship Safety performance should be verified by the user e g qualified service personnel at least twice a year Ground resistance leakage current and dielectric withstand voltage must be checked to appropriate national standard To avoid unnecessary shipping please contact your Alcon Technical Services Department prior to return of any system or accessories If return of the equipment is deemed necessary a Return Material Authorization will be issued with appropriate shipping instructions Alcon Laboratories Inc Technical Services Department 15800 Alton Parkway Irvine California 92618 3818 949 753 1393 or 800 832 7827 LIMITED WARRANTY Alcon will repair or replace at its option any system or accompanying accessories found to be defective in material and or workmanship for a period of one 1 year from the date of initial installation This warranty applies to the original purchaser of the system when said system is properly installed maintained and operated in accordance with published instructions Alcon shall not be obligated to provide services under this warranty for damage to or destruction of syste
94. ied by the operator for correctness and completeness before progressing from one screen to another It is recommended to perform a probe check prior to starting a biometry session A probe check should also be done when a new probe is used On systems 685 0000 502 and above see REF number on label pressing and holding the standby switch for 7 seconds then releasing will reset reboot the system CAUTIONS This device is intended for healthcare professionals who are trained in A scans IOL power calculations and or pachymetry measurements Do not clean console and accessories with solvents or abrasives irreparable damage will result Biometry and Pachymetry probes are fragile components which must not undergo rough use or handling this can destroy or alter operation of the probe Avoid touching touch screen with gel or sterile prism solution To ensure compliance with IEC 601 1 1 requirements for medical electrical systems do not use power strips portable multiple socket outlets to power the OcuScan RxP system Using the system with a hospital grade power cord and proper hospital grade grounded electrical outlet assures electrical safety In accordance with ALARA principles the energy delivered to the eye should be as low as is reasonably achievable If the identification of the IOL or its constants is changed be sure to update the A Constant S Factor and ACD Consult the IOL manufacturer if you have questions regarding IOL consta
95. ight 30 5 cm 12 0 inches Width 30 5 cm 12 0 inches Internal Video Display SVGA 800 x 600 Depth 27 9 cm 11 0 inches External Video SVGA WEIGHT Packed Unpacked Biometry Console amp Accessories 6 62 kg 4 85 kg Probe frequency 10 MHz 1 MHz 14 60 Ibs 10 70 lbs Theoretical Accuracy 0 05 mm Clinical Accuracy 20 1 mm ENVIRONMENTAL REQUIREMENTS Axial Length Range 15 39 mm Operating Storage Gain Range Adjustable from 40 to 80 dB Memory Biometry Measurements 10 per eye Temperature 10 C to 35 C 10 C to 55 C Physician Settings 5 50 F to 95 F 18 F to 131 F IOL Slots per Setting 10 editable Display AL 10 average AL Altitude 125 m to 2500 m 125 m to 6100 m Standard Deviation Lens thickness ACD and Vitreous Humidity 30 to 75 10 to 95 IOL Formulas Holladay SRK II SRK T Binkhorst II Hoffer Q Noise Level Sound pressure level does not exceed Haigis optional 44 dbA measured at one meter Pachymetry Probe frequency 20 MHz x2 MHz ELECTRICAL CHARACTERISTICS Resolution 1 um The instrument automatically sets itself to operate with the Accuracy 5 um supplied voltage and frequency Measurement Range 100 350 400 700 and 300 1100 um Bias Input AC Voltage Current 100 120 V 200 240 V 2A Actual Actual measurement to power supply Percentage 0 to 300 Absolute 999 to 999 um Frequency 50 60 Hz Gain Auto adjusting Memory Input DC Voltage Current 24 VDC 2V with minimum of Single Point
96. ine IOL powers are displayed in 0 5D steps that would result in the closest refraction around the target ametropia Comparison Screen 22 Tap the Next Screen button right arrow on the IOL Calculation screen to advance to the next screen selected in the Settings sequence The Comparison screen shown in Figure 3 24 allows the user to compare the IOL power calculations with five different formulas for the three IOL s which were selected on the IOL Calculation screen The user can select OD right or OS left eye If data does not exist for the eye selected then the IOL calculations will be blank IOL power calculations are displayed for both the emmetropia and ametropia 3 36 8065750127 OcuScan RxP Measuring System Formula Configuration Screen The Comparison screen can be replaced by a Formula Configured IOL Calculation screen where the formula is selected based on length of the eye In this screen the user selects the eye length ranges and the preferred formula for each range 23 24 25 26 8065750127 Tap the Formula Config button The Formula Configuration window is displayed giving the user the option of replacing the default Comparison chart with a set of three IOL calculation charts These three charts are all calculated using the formula selected for the range that the patient s axial length is within The fields for axial length are variable within the range of 15 39 mm The default AL values are 22 00 and 24
97. ing green button indicates reading is within selected thickness range solid green button indicates reading is in selected thickness range and has been recorded solid pink button indicates reading is out of selected thickness range Figure 3 29 Settings Frame Contains current settings Tap on Screen to open the Pachymetry Presets screen 03 11 2005 14 35 Patient First Name Last Name ID OD OS Button Tapping this button toggles between OD and OS Mode Screen Tap the screen Tap button to change button to toggle mode Available modes thru Maps Menu are Manual Auto Lasik and S Auto 1 and 2 Lasik Tap here to return and Single to menu screen Point PACHYMETRY SCAN Settings Preset Preseti Operator Operator 1 Cornea Velocity 1641 Delete Button Deletes the current selection Pressing the button for more than 1 second will display the option to delete all readings Map 1 AUTO 400 To 700 Menu Bias Mode Toggles between actual absolute amp percentage bias Actual Thickness Range Toggles between 100 to 350 400 to 700 and 300 to 1100 Readings Displays Last Average and Minimum readings Print Save Button Tapping this button activates the action selected in the System setup PACHYMETRY MAP 1 or 2 Maps 1 and 2 can be configured with up to 25 locations for taking corneal thickness measurements Values can be entered for Desired Abl
98. intaining a minimum distance between portable and mobile RF communications equipment transmitters and the OcuScan RxP Measuring System as recommended in Table 1 3 according to the maximum output power of the communications equipment Table 1 3 Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the OcuScan RxP Measuring System Separation distance according to frequency of transmitter Rated maximum output m power of transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz w d 1 2VP d 1 2VP d 2 3VP 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 12 12 23 Note 1 For transmitter rates at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Note 2 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies Note 3 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 1 10 8065750127 OcuScan RxP Measuring System Universal Precautions Universal precautions shall be observed by all people who come in contact with the instrument and or accessories to help preven
99. ion Speed Volume meo O O Three speeds are available Low Medium amp High Gain Acquisition Speed Low yl 9 This selection determin idation ES idation s selection dete es TAGE ATTE ORIS oo El Validation ON Setup Validation RC See Validation Menu EDI O 3375 below Haigis only the sequence of screens used during the Biometry procedure Once the sequence is selected the user can move through the procedure using the arrow keys Pseudo IOL Defaults Selecting an entry and tapping Edit opens an edit window where values can be changed IOL EDIT Audio Feedback Sequence Keratometer Index Details Calculation Comparison Pachymetry Available in the Haigis formula option only Pseudo IOL Defaults Phakic IOL Defaults a Phakic IOL Defaults Material Velocity Thicknes Material Velocity Thicknesq 1 DICIT aan Io O ZEE 71 77 NEED Selecting an entry and Acrylic 2120 b Acrylic 2120 t Edit PMMA j PMMA apping s IL Opens an edit window where Custom1 E Custom4 Custom2 l E Customs values can be changed Custom3 5 Custom6 Lens Constants Lens Constants Audio Feedback Displays the Lens A beep based feedback signal that Constants screen increases in speed as the quality of acquisition improves nuc Velocity peo Validation Menu Validation Menu Selecting one or more of the following options will enable a Thickness po button displays the menu on t
100. its production This equipment may also contain hazardous substances which could have potential effect on the environment and human health if disposed of improperly In order to avoid the entry of any such substances into our environment and to promote natural resource conservation we encourage you to use the appropriate take back systems Such take back systems reuse or recycle many of the materials in your end of life equipment in a beneficial way Please contact your local Alcon office for assistance in take back options through Alcon or other providers The crossed bin symbol located on this equipment reminds you to use take back systems while also emphasizing the requirement to collect waste equipment separately and not dispose of it as unsorted municipal waste If you need more information on the collection reuse or recycle systems available to you please contact your local or regional waste administration or contact your local Alcon office for more information OcuScan RxP Measuring System Safety Requirements The OcuScan RxP Measuring System complies with the following safety agency standards for medical instruments IEC 601 1 IEC 601 1 1 IEC 601 1 2 IEC 601 1 4 UL 2601 The system meets all essential requirements of Medical Device Directives 93 42 EEC The system complies with FDA acoustic power measurement limits IEC 60601 2 37 and meets the Acoustic Output Declaration Exemption for IEC 1157 1 Acoustic Output M
101. ken for that scan If the footswitch is pressed within the 4 seconds the blinking moves to the previous location without becoming pink This selection cycle goes in reverse order through the readings After all configured up to 10 readings are taken for the selected eye you can switch to the other eye by tapping OD Right Eye or OS Left Eye or pressing and holding the footswitch for 5 seconds To begin the measurement press and release the footswitch or tap the scan 1 and it will blink indicating it is ready IOP IOP Adjustment is displayed only when the selection is Actual The user enters measured IOP and based on the average CCT value the system will calculate and display Adjusted IOP The formula used for CCT based adjustment is based on a conversion table developed by Dr Leon Herndon MD and assistant professor at Duke University Medical Center Dr Herndon s table is a modified version of original conversion factors developed by Dr N Ehlers 1 Leon Herndon MD Rethinking Pachymetry and Intraocular Pressure Durham N C Review of Ophthalmology July 2002 8065750127 3 47 OcuScan RxP Measuring System Pachymetry Scans using the Map Screens The Map Screen shown in Figure 3 29 enables the user to take measurements in up to 25 programmable locations positioned in the general topography of the eye Note Only one of these screens can be used for a particular patient Begin taking measurements by tapping a position butt
102. lculate the Average reading and Standard Deviation for that eye When the measurement is deleted it is also eliminated from the Biometry Scan screen BIOMETRY DETAILS Settings Preset Preseti Operator Operator 1 Technique Contact OD Right Eye OS Left Eye Type Phakic Type Phakic Reading s taken using Average K Average K AL mm AC mm L mm Y mm AL mm AC mm L mm Y mm a a a a A AAA the Force Freeze function are blue and use a smaller font Reading s farthest from the Avg axial 3 66 18 07 length are pink Sr y umi Reading s closest to the Avg axial length are green Average axial length N Tap the Delete button and Standard Deviation to delete the selected of the ten readings entry Figure 3 22 BIOMETRY DETAILS SCREEN This screen shows an overview of up to ten scans each for the right and the left eye The detail data consists of Axial Length Anterior Chamber Lens and Vitreous along with the Average reading and Standard Deviation for each of the sections 3 34 8065750127 OcuScan RxP Measuring System IOL Calculation Screen 18 Press the Next button right arrow on the Biometry Details screen to advance to the next screen selected in the Settings sequence The IOL Calculation screen shown in Figure 3 23 can be used by the operator to perform IOL power calculations using three different user selectable IOL Formula combinations The system calculates and displays IOL
103. lows you to toggle between actual measurements absolute bias 999 to 999 um and percentage bias 0 300 The values used for absolute and percentage bias are entered in the Settings screen The Thickness Range determines the range that a reading must fall within to be valid The three thickness ranges to select from 100 to 350 um 400 to 700 um or 300 to 1100 um Tap any scan on the Single Point screen The position starts blinking When the system receives a measurement within the range shown on the Thickness Range button the position turns green and the measurement is displayed but will remain blinking until the footswitch is pressed and released to capture the measurement If the measurement is outside the selected thickness range the position will turn pink Place the pachymetry probe on the patient s eye When a valid measurement is displayed on the blinking position button press and release the footswitch to capture the measurement The measurement is displayed on the scan button which will turn light green if the measurement is within the selected thickness range or pink if the measurement is out of the thickness range The next position button in the sequence will start blinking as it waits for another measurement If a measurement must be retaken in a position tap the button and it will delete the old measurement then a new measurement may be taken to replace it Pachymetry Scans in Auto Mode 3 46 In Auto M
104. mation of the acquired measurement value is provided Audio feedback mode provides the user with feedback of signal integrity Internal Printer The current screen or a full report of the patient data can be printed on the internal printer Probe Holders The console contains probe holders on both sides of the viewing screen to hold Pachymetry probe on one side and Biometry probe with or without sleeve on the other side Stylus Above the touch screen is a hole used to store the plastic stylus Either the stylus or your finger can be used to select a function or to enter data CAUTION Do not use a sharp object in place of the stylus as it may damage the touch screen 8065750127 OcuScan RxP Measuring System Rear Panel The rear panel contains the power input connector and connectors to interface with system accessories see Figure 2 2 Labels on the rear panel identify each of the components and also warn the operator of possible dangers Rear Panel Components e Power Input Connector 24 VDC power enters the rear panel through an 8 pin din connector 24V e External SVGA Video Output Connector The system provides a standard SVGA output connector for an optional monitor e Footswitch Connector The footswitch connects to this Mini Din connector Ethernet Connector The Ethernet interface on the rear panel is used for network connection gt c USB Connector The USB bus connection is used to store and ret
105. ments in Automatic Auto Mode 14 15 16 3 32 Select Auto mode by tapping on the Mode button Press the footswitch and place the Biometry probe on the patient s eye A continuously updating axial length reading is displayed in the upper right corner of the echogram based on the current axial length For best readings ensure that both the waveform and the axial length number are black as these measurements will automatically save Blue values must be saved using the force freeze feature by quickly pressing and releasing the footswitch Adjust the Gain and align the probe to obtain clear and equal amplitudes of C1 and C2 peaks in immersion mode along with L1 L2 and a vertical shaped retina peak then release the footswitch In Contact mode look for L1 L2 and vertical retina peaks then release the footswitch The system will take ten measurements if it can lock on the C1 C2 L1 L2 and R peaks In contact mode C1 is fixed The echogram auto lock algorithm is based on amplitude and location of the peaks and should function adequately for most eyes In some cases where the amplitude of the peaks are not high enough or the peaks are not located within the software range the system may not auto lock In these cases the user may have to use the Forced Freeze Capture option or select Manual mode to obtain measurements The measurements closest to the average are shown in the color green and those farthest away from the average ar
106. most of the working screens Pressing the top button toggles The Print Save through the following options Button e Display menu Displays the options window shown in Figure 3 5 e Full Report and Save Prints a full report see Figure 3 6 and saves the data to the current patient s records 1f a Compact Flash card is inserted e Current Screen Prints the current screen only e Full Report Prints a full report for the current patient 10 Press and release the top button in the Records field to cycle through the options Stop on Full Report or Full Report and Save When Full Report or Full Report and Save have been selected the Define Report button becomes active Pressing the button opens a window that allows the user to select which items shown in Figure 3 5 will be printed each time the print button is pressed When saving a file that has already been saved the system will provide the following options Overwrite the existing files overwrites patient s file with new data created since the last save e Save as new file Saves data in a new file and adds an extension number to the name For example file named 007 will be saved as 007 1 Esc returns to the previous screen without saving data Print Full Report Define Report DEFINE REPORT lt Biometry Scan IOL Calculation Comparison lt Current Screen Save Biometry Details Pachymetry Scan EES Esc Print
107. ms covered where such damage or destruction is a result of or caused by fire or explosion of any origin riot civil commotion aircraft war or any Act of God including but not limited to lightning windstorm hail flood or an earthquake This warranty does not cover damage resulting from service repair or other alteration by any person other than an Alcon authorized service person and any warranties provided by Alcon with respect to this equipment shall become void and of no further force and effect 1f this equipment is serviced by anyone other than Alcon authorized service personnel In particular Alcon shall have no obligation to replace repair or credit customer s account for the cost of the equipment which has been subject to service or other alteration by persons other than Alcon authorized service personnel THE EXPRESS WARRANTY ABOVE IS THE SOLE WARRANTY OBLIGATION OF ALCON AND THE REMEDY PROVIDED ABOVE IS IN LIEU OF ANY AND ALL OTHER REMEDIES THERE ARE NO OTHER AGREEMENTS GUARANTEES OR WARRANTIES ORAL OR WRITTEN EXPRESS OR IMPLIED INCLUDING WITHOUT LIMITATION WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE ALCON SHALL HAVE NO LIABILITY WHATSOEVER FOR ANY INCIDENTAL OR CONSEQUENTIAL DAMAGES ARISING OUT OF ANY DEFECT IMPROPER USE OR UNAUTHORIZED SERVICE OR REPAIR 8065750127 OcuScan RxP Measuring System Table 1 4 OCUSCAN RxP SYSTEM SPECIFICATIONS CONSOLE DIMENSIONS SYSTEM PERFORMANCE He
108. ms that may occur with the system Table 5 1 contains three columns of information The first column labeled Condition Or Error Message lists the observed problem The Possible Cause column lists the possible reasons for the observed problem The last column labeled Correction suggests how to correct the problem If after performing the recommended corrective action the system continues to malfunction contact your local Alcon service representative CONDITION OR ERROR MESSAGE System does not turn ON and front panel LED does not illuminate when power switch actuated POSSIBLE CAUSE Power not reaching OcuScan RxP system CORRECTION Check that power cord is properly connected to power source wall outlet and the console rear panel Check that the Power on switch on the power supply is ON Screen is blank and LED is OFF System is in standby state Press the Standby button When print is initiated system advances paper but there is no printout Improper orientation of the printer paper Load the paper with the proper orientation as shown in Figure 4 1 Scans contain a lot of noise or strange waveforms Probe connector not seated properly in the rear panel connector Ensure probe is properly connected to rear panel No A scan when system is in running mode and probe is placed on eye model or eye Improper connection or system configuration Confirm that the Biometry probe is properl
109. mum of 1800 patient files saved in this format PC Format Excel This format allows you to view the patient data on a Personal Computer PC using a Patient Viewer template that is included on the CD provided with the system The file size is about twice the size of the Compact Flash file therefore only half as many patients can be stored on the Compact Flash card in this format as compared to the Compact Flash binary format For additional information refer to Copying Patient Data to a Personal Computer 12 Press OK to accept the changes and return to the Menu screen Pressing the Esc key exits the System Setup screen without implementing any changes and returns to the Menu screen NOTE The Service Menu is intended for use by service personnel only therefore a password is required to enter that area 8065750127 OcuScan RxP Measuring System PATIENT RECORDS SCREEN The Patient Records screen shown in Figure 3 7 allows the user to manage and select patient data It is used to e Display patients currently saved to the Compact Flash card if inserted e Sort the patients by identification number last name or first name Remove a patient from the database NOTE The Patient Records screen only displays patient records saved in the currently selected Patient Format in the System Setup screen For example if PC Format is selected then only those files saved in PC Format are displayed If Compact Flash format is select
110. n the red stripe appears tear off the paper then press Reverse in the System Setup screen to back the paper out of the printer Install a new roll as described in the following steps I From the Menu screen tap System Setup On the right side of the screen there are three buttons that control the printer paper movement Load Forward and Reverse Place paper roll into the system in the position shown above Ensure that the paper has a straight cut before loading A straight edge perpendicular to the outside edge of the roll is critical to proper loading Open the printer door located on the front of the console and insert the roll of paper in the orientation shown in Figure 4 1 Insert the paper into the opening under the black roller Insert paper into gap underneath black roller then press the Load Press the Load button The paper will automatically load and should button run smooth and straight through the black roller If not press reverse to remove the paper then attempt to load again zoo Press the Load button again and tear off the excess paper Figure 4 1 PRINTER PAPER INSTALLATION This illustration shows the proper orientation for installing the printer paper LAST PAGE OF SECTION 8065750127 OcuScan RxP Measuring System SECTION FIVE TROUBLESHOOTING OcuScan RxP Troubleshooting Instructions This section of the manual is designed to help identify and correct proble
111. ness readings for several positions pressing the footswitch deletes the previous position s value The position button will start blinking indicating that it is ready to acquire new data for that position In Single Point quickly pressing and releasing the footswitch will step back through the measurements A selected measurement starts blinking and turns pink if the user does not press the footswitch again within 3 seconds Pink readings are deleted and new measurements can be taken If the user has pressed the footswitch within 1 second then the blinking would move to the previous location without turning the current location to pink After all the configured readings have been taken for one eye OD pressing and holding the footswitch 5 seconds selects the other eye OS When the system has switched to the other eye pressing and releasing the footswitch will cause the position to start blinking indicating that the system is ready to take the measurement Manual Mode In Manual mode the position button starts blinking by pressing the footswitch Holding the probe perpendicular on the corneal position displays the current thickness Pressing the footswitch locks the reading for that position and advances to the next position 8065750127 OcuScan RxP Measuring System Probes and Probe Holders The OcuScan RxP Measuring System comes with probe holder cradles on each side of the viewing screen where the Biometry and Pachymetry probe
112. nt by pressing the Print button at the bottom of each page 8065750127 OcuScan RxP Measuring System Aleon Patient Files Biometry Pachymetry System Settings Language Define Print English O Biometry O Francais Pachymetry Deutsch O Italiano Japanese O Print Portugues O Espa ol Figure 3 37 SYSTEM SETTINGS IN THE PATIENT VIEWER This screen shows the systems settings displayed on a PC using the Patient Viewer 7 Click on the Biometry tab to view the biometry patient data as shown in Figure 3 38 8 Click on the any of the ten measurements in the display window to display the waveform of that measurement 9 Zoom in to a specific area of the patient waveform by left clicking on the waveform and dragging over the area to zoom in on then release the mouse To un zoom right click on the waveform and select Undo all Zoom Pan 10 Save an individual waveform to a file for further observation by right clicking on the waveform and select Save Image As 8065750127 OcuScan RxP Measuring System Patient Files Biometry Pachymetry System Settings Patient Name Doe Joe OD Right Eye Type Phakic K1 45 00 K2 50 00 KAvg 47 5 Wto WW 10 00 Before Refractive T K1 K2 Before Refractive Surgery Sphere Cylinder Vertex Preset Operator Technique Gain Patient ID 07 26 04 OS Left Eye
113. nto various IOL calculation formulas the system calculates the power of the intraocular lens to be implanted in the patient s eye Figure 1 1 OcuScan RxP Measuring System Pachymetry consists of measuring corneal thickness at one or several points on the cornea It is often performed during a Biometry examination and prior to refractive surgery such as Lasik or PRK Corneal thickness measurements may aid in determining the risk of developing Glaucoma and the evaluation of intraocular pressure IOP Please take a few minutes to familiarize yourself with the OcuScan RxP Measuring System by scanning patients with previously known diagnoses and measurements Experiment with various clinical situations until you feel comfortable with your new system Various enhancements have been made in both Contact and Immersion modes therefore if you are using customized constants derived on a system other than the OcuScan RxP Measuring System it is recommended to derive new customized constants using the OcuScan RxP Measuring System This operator s manual is designed to provide the necessary information for setting up and learning to operate the system and to provide a reference source for the various menus and selections The most effective use of diagnostic ultrasound requires a complete understanding of the functional aspects of the instrument and the clinical significance of ultrasound traces Users of ultrasonic equipment should study professi
114. nts It is very important to verify that the correct default velocities and thicknesses are displayed prior to measuring Axial lengths and corneal thickness Prior to initiating the COMPUTE function in the LENS CONSTANT UPDATE screen verify the data entered is correct WARNINGS The Alcon Laboratories ultrasound probes and equipment are NOT designed or intended for fetal use Not suitable for use in the presence of flammable anesthetic oxygen or nitrous oxide Do not use this product on eyes when corneal integrity is compromised by infection or trauma Do not use the system if it displays error messages or acts erratically 8065750127 OcuScan RxP Measuring System EMC Statement 8065750127 It is important to install and use the equipment in accordance with the instructions in order to prevent harmful interference with other devices in the vicinity If this equipment causes harmful interference to other devices determined by turning the equipment off and on the user is encouraged to try to correct the interference by one or more of the following measures e Reorient or relocate the other device s e Increase the distance between the equipment e Connect this equipment into an outlet on a circuit different from that to which the other device s is connected Consult the manufacturer or your Alcon field service engineer for help CAUTION The OcuScan RxP Measuring System needs to be installed and put into servic
115. ode the system automatically captures a reading when a valid measurement is detected 12 Tap the Mode button to switch to Auto mode 13 Tap any position button on the screen The position starts blinking 8065750127 OcuScan RxP Measuring System 14 Place the probe on the patient s cornea The system automatically captures a reading when a valid measurement is detected then advances to the next position and blinks Pachymetry Scans in S Auto Mode Super Auto mode is the same as Auto mode except that a minimum of three valid readings are taken and the smallest measurement is recorded The smallest measurement indicates that the probe is perpendicular to the cornea If the sound setting is enabled a voice confirmation of the reading is announced For Maps 1 and 2 the user can go back and retake the previous reading by pressing the footswitch Pachymetry Scans using the Single Point Screen In Single Point screen the eye selected is highlighted either OD or OS After all the configured measurements are taken for an eye you can select a point and delete as needed Pressing the footswitch and releasing in less than 1 second will make the last reading blink In Auto repeatedly pressing the footswitch will scroll through each scan causing each one to blink If the footswitch is not pressed within 4 seconds to move to the previous location then it turns pink indicating that the reading was deleted and a new reading must be ta
116. on on the screen The Manual Auto and S Auto modes function the same as in Single Point mode In all modes the next position can be set manually by tapping the next position on the screen Pachymetry Scans using the Lasik Screen 3 48 To begin capturing measurements in the Lasik Screen Figure 3 30 the user selects one of the four Lasik phases then selects a position in that row Once scanning begins the system keeps scanning until three valid measurements have been taken The system records the smallest minimum of the three measurements The Manual Auto and S Auto modes function the same as in Maps 1 and 2 Values for Desired Ablation and Flap Diameter can be entered for reference by tapping in the associated field The five columns to the right of the readings are used as follows Min minimum reading for each phase Flap Achieved Pre Op Minimum Post Flap Minimum Potential Ablation Post Flap Minimum Target Residual Bed Ablated Post Flap Minimum Post Ablation Minimum Potential Enhancement Post Op Minimum Flap Achieved Target Residual Bed 8065750127 OcuScan RxP Measuring System COPYING PATIENT DATA TO A PERSONAL COMPUTER CAUTION The patient data stored on any device other than the OcuScan RxP is not validated by Alcon therefore it can be used for reference only The data stored on other devices such as a PC should never be used for diagnosis or calculation of IOL power IOL calc
117. onal literature and obtain approved medical training in the interpretation of ultrasound traces and in obtaining accurate measurements of the eye s axial length and corneal thickness Professional literature should also be used to decide on the appropriate IOL power calculation formula for a particular patient 8065750127 14 OcuScan RxP Measuring System QUICK START 1 INSTALL THE SYSTEM 1 1 NOTE For detailed setup information refer to Section Three Operating Instructions 2 SYSTEM SETUP 2 1 2 2 2 3 2 4 2 5 2 6 2 7 2 8 3 SETTING UP THE BIOMETRY PRESETS E NI 3 2 33 3 4 3 3 3 6 3 7 3 8 4 ENTERING PATIENT DATA 4 1 4 2 4 3 4 4 4 5 4 6 5 The OcuScan RxP Measurement System is now ready to perform biometry examinations and calculate the IOL power NOTE Be sure to save the data after the exam The Save button is available on the Patient Information screen or by pressing the Print Save button if it is programmed to Display Menu Perform the installation instructions on the next page From the Menu screen tap or press System Setup Input the Clinic and Operator names Tapping on a field will display a keyboard that allows you to input the textual information There are five operator s selections that can be named as desired Set the action of the Print Save button using the Records selection Tapping the button advances through the four selections as follows Current Sc
118. onstants screen without saving the changes or the Trash button to delete an entry All the three constants A ACD and SF must be entered when a new IOL is added or modified Refer to Table 1 5 for IOL constants The Reset button allows the user to reset the selected row to the factory default IOL and its constants NOTE If the Haigis option is installed then A0 A1 and A2 will also be reset When any of the IOL s in the Lens Constant screen are edited the designation in the I U C column changes from I Initial to U User Change When constants are calculated using postoperative data in the Lens Constant Update screen it changes to C Calculated 8065750127 OcuScan RxP Measuring System Lens Parameters Tap on a row of values to display the edit box MN60D3 8065750127 10 12 2005 21 23 V112 BIOMETRY PRESETS LENS CONSTANTS Preset 1 Name Preset1 o IBI 0 Company Type A SN60WF v 5 37 1 62 SN60D3 5 02 1 28 5 14 1 39 SN60AT 520 145 MN60AC 520 145 MA60AC 520 145 SA60AT 520 145 MA60MA 549 1 73 MTA4U0 295 0 31 ooh I ud Esla as Eo La 10 Bera Ese HI SA60D3 5 02 1 28 Lens Constant Update OK Esc Columns AO A1 and A2 Row Number s apply to Haigis formula only and will be displayed only if the Haigis formula is installed iot Company Type ACD E SF ZELLE arcos posteos N as A0 Al A2 0 EINEN IHNEN ILIO Hm Hh Tapping on the Reset Button will rest
119. ore the factory default IOL and its constants Figure 3 12 LENS CONSTANTS SCREEN This screen allows the user to make changes to the default values used for the lens constants 20 Tap the Lens Constant Update button The Lens Constant Update screen appears as shown in Figure 3 13 Lens Constant Update Screen The Lens Constant Update Screen enables the user to customize the A ACD and SF constants using the patient s preoperative and postoperative data for any of the ten stored lenses on the selected Doctor Settings Screen The A constant is used in the SRK T and SRK II formulas SF is used in the Holladay formula and ACD is used in the Binkhorst II and Hoffer Q formulas Although the system will compute the constants based on a single patient case a minimum of twenty patient cases should be used in order to achieve higher statistical significance in the prediction of new constants The system will accept up to fifty patient cases NOTE Use pre op data for K1 K2 and AL and post op data for SPH and CYL The Lens Update Screen displays the name of the lens for which the constants are being changed along with its constants To select a lens tap the drop down menu beside the lens name then tap on the desired lens 3 19 OcuScan RxP Measuring System a LENS CONSTANT UPDATE Lens Select lens Constants Tvne A ACD sr uc mme Current P 118 9 5 49 1 73 1 Number of Exclusions Calculated SEN Lens Data K2 AL CY
120. ormulas 4 Comparison Compare IOL calculations with five formulas for three selected IOL s Figure 3 1 8065750127 Formula Configure Uses IOL Calculation Formula based on the size of the eye of the OcuScan RxP Measuring System PATIENT RECORDS Manage patient data SYSTEM SETUP Customize the system to meet your specific needs PROBE CHECK Verify that each probe is functioning properly FUNCTIONAL FLOWCHART This flowchart shows the sequential functions 3 1 OcuScan RxP Measuring System SYSTEM POWER UP System Reset 3 2 When power is applied to the system a power up screen appears containing the OcuScan RxP logo During the power up state the system performs self tests for about three seconds If any of the self tests fail a message appears on the bottom half of the screen to notify the user If the self test failure is a prompt the user can continue after acknowledgment by pressing the OK key If it is a system failure the user cannot transition out of the screen After successfully completing the self tests the Menu screen appears It is not necessary to turn the system OFF A Screensaver mode is activated after the screen and footswitch have been inactive for ten minutes Figure 3 2 shows the screensaver display Tapping the screen will deactivate the screensaver If the system is inactive for another 15 minutes after entering screensaver mode the system enters the standby
121. played when the Next screen Arrow button is pressed When all the selected screens have been displayed the system loops back to the 1st screen The Patient Information and Scan screens are always enabled 15 Select or deselect each screen as desired in the Sequence frame Pseudo and Phakic IOL Defaults By selecting a material in the Pseudo or Phakic IOL Defaults list you can modify the name velocity and thickness of the selected material 16 Select the material to be changed in the Pseudo or Phakic IOL Defaults list then tap the Edit button 17 Tap inside the field to be changed enter the new value and tap OK to accept the change Lens Constants The Lens Constants screen shown in Figure 3 12 provides the user with the choice of ten IOL s for each setting The IOL s shown here will be a selection in the IOL Calculation screen see Figure 3 23 for calculating IOL power Each entry can be edited to match the user s preferred IOL values The AO Al and A2 entries are used in the optional Haigis formula only and will not be displayed if the Haigis option is not installed The factory defaults used for A Constant is from the lens manufacturer s specifications 18 Tap the Lens Constants button The Lens Constants screen appears as shown in Figure 3 12 19 Tap one of the rows in the Lens Constants table The row number appears and fields for all entries can be edited Press OK to confirm the new values Esc to return to the Lens C
122. re Refractive Surgery sso dap a s do aa Tp Pg A gd Apa pe a 3 25 Refractive Error Before Refractive Surgery usua oaa e aaa A 3 25 Refractive Error After Refractive Surgery acu oui Ra OUR PR RU ie AR I de Ro NC 3 25 Adjusted K gargs ear ae E EE 3 25 Biometry SCAMS us sasa cai A E ose ed he E A AA Rd da 3 27 Biometry Measurements in Manual Mode ac os oad EE a doe etes m CR UR aci s se 3 28 Editing the Gate Positions ca amp Ghia gwen Ro COE RUN EXTR Dui RCUAR ee AR apace A Caw PCR Rd 3 30 Biometry Measurements in Automatic Auto Mode 0 2 2 eee eee eee 3 32 Biometry Scans in Super Automatic S Auto Mode 2 0 eee ee eee eee 3 33 Biometry Details Sereen eas anus Sua Dore AAA 3 34 OL Calcul apod Sere Gere iia a cd an at ee Pe ERR ROC OE SR n prs Pu t cis ua oe el Ee ee 3 35 COMPA a Sea howe GaGa a a Vp ieri MR did 3 36 Formula Configuration SEPBEL arcada e ti Ree do 35 37 PACHYMETRY ctu ues s Cora ep yen clie p EA AAA AAA E CUR IAN TOS 3 39 Setting Up the Pachymetry Presets cocer gae boue Seb aco Pw RR A RS ede n RR erg a RC 3 39 SNES DNE ERR a E rrr 3 40 la o RA O 3 41 Map Map ta ERA AER A E eee 3 41 The Lasik SICA a AAA AAA AAA 3 41 Pachymetry SAI a AR A AA Ada 3 43 Pachymetry Patient Setup cdi 3 43 Pachymetry scans an Manual Mode relaves 3 46 Pachymetry Scans m Auto Mode escana c Rt e ARCU RR Oe RR RE 3 46 Pachymetry Scans qn S Auto MODE scs lt nace 44 04 ae yer o 8 3 47 Pachymetry Scans using the Single Point S
123. reen Full Report Full Report and Save and Display Menu Enter the Date and Time Select a Language Select the Video Mode LCD only or SVGA mode to connect an external monitor Select a Save Patient Format Use PC Format if you plan to export patient data to a Personal Computer otherwise use Compact Flash format to conserve space on the optional Compact Flash card Tap OK to return to the Menu screen When prompted tap the checkmark button to save the changes From the Menu screen tap the Biometry button Tap in the Settings frame to enter the Biometry Presets screen Enter a name for each of the five available Presets as desired Change to a different preset by tapping on the Preset drop down menu then tap on a different Preset number Change the default Settings as necessary Select the screens in the Secquence box that will be displayed during the procedure The Sequence determines which screen will be displayed next when tapping the Next arrow button When the end of the sequence is reached the system loops back to the beginning If necessary edit the Pseudo or Phakic IOL Defaults to your desired values First select a Material then tap the Edit button Enter the desired changes in the IOL Edit box Enter your preferred lenses in the Lens Constant screen Tap OK to return to the Biometry Scan screen When prompted tap the checkmark button to save the changes Tap the Patient frame Tap the New Patient button Enter a Pati
124. rieve patient data to and from a e PC e RS232 Connector RS 232 serial communication connects the system to an external PC for service use U Biometry Probe Connector Use this connector to plug in the Biometry probe C3 Pachymetry Probe Connector PACH Use this connector to plug in the Pachymetry probe OOOO Ou DE a diis cedo I 9 gau gt 101010 PACH Figure 2 2 REAR PANEL The rear panel contains a variety of connectors used to connect power handpieces the footswitch and accessories 8065750127 2 3 OcuScan RxP Measuring System Flash Card Slot Eye Model 2 4 The side panel contains a flash card slot where a Compact Flash card can be inserted for storing patient data or upgrading the system software see Figure 2 3 The OcuScan RxP Measuring System is a computerized machine that operates under software control If and when software upgrades are required the new program can be installed into the system through the use of a Compact Flash card For instructions on installing software upgrades refer to Installing Optional Software and Upgrading System Software in Section One of this manual In the base of the console behind the touch screen is a contact type eye model used for the probe check see Figure 2 3 A probe check determines system functionality and tests probe strength by measuring the Eye Model axial length The eye model is designed to display traces to simulate peaks for conta
125. s already displayed on the Biometry Scan screen the same information will appear on this screen The current information can be changed or new patients can be entered by tapping the New Patient button which will prompt you to save the current patient if one was displayed then clear all the fields for the new data Previously saved patients can be selected from the patient list by tapping the Patient List button When the New Patient button is pressed to enter a new patient all settings that were changed for the previous patient is returned to the default value Settings that were changed such as the Gain in the Biometry Scan screen are also returned to the default value 3 Tap the New Patient button NOTE Always start a new patient by first activating new patient key Do not manually erase the old patient data and enter new patient 4 Tap the Patient Name field The large field is for the last name 20 character maximum while the smaller field is for the first name 3 character maximum A keyboard appears see Figure 2 8 and a dialogue box that allows you to accept or cancel the name entered 8065750127 OcuScan RxP Measuring System Presets Select the Presets for each patient here The Operator is setup in the System Setup screen The presets are setup in their respective preset screens Patient Info Tap inside each field to input patient data A patient ID is required in order to save New Patient patient data Tap t
126. s are placed when they are not being used The holder for the Biometry probe is on the right side of the monitor while the Pachymetry probe the holder is on the left Three methods of using the Biometry probe can be employed see Figure 2 5 It can be held with or without its applicator for contact scans it can be removed from its applicator for immersion scans or it can be removed from its applicator and placed in a slit lamp adapter E u Applicator Figure 2 5 BIOMETRY PROBE Three methods of using the biometry probe are employed in biometry In the upper illustration the probe is inserted into its spring loaded applicator This applicator applies a consistent light pressure to the cornea for scanning In the lower illustration the probe is removed from its applicator and can be placed in a slit lamp adaptor or used in an immersion shell Straight Probe Angled Probe Figure 2 6 PACHYMETRY PROBE The optional Pachymetry probe fits comfortably into the operator s hand for effortless corneal thickness measurements Two models are available straight and angled 45 8065750127 2 7 OcuScan RxP Measuring System External Power Supply The OcuScan RxP Measuring System is powered by one of the two external universal power supplies shown in Figure 2 7 These supplies provide a DC voltage of 24 V and a minimum of 3 3 A to the console They require a steady state input voltage in the range of 100 120 200 240 VAC 2 A at 50 60 H
127. s in the form of amplitude and ranges If the echograms do not meet the normal software criteria but are still within the axial length range of 15 39 mm the readings are displayed in smaller fonts and blue color The readings with smaller fonts and blue color require in depth review by the user to ensure validity If all peaks were found within the range but some of the amplitudes were lower than normal then the resultant axial length measurement is displayed in smaller fonts and blue color If all peaks were not found or if peaks were outside the range then the readings will be displayed as 0 00 and gates will be placed in the default position If the user reviews the peaks and moves the gates to appropriate locations then the 0 00 will be replaced with the axial length measured Corneal Cornea2 Lens1 Lens2 and Retina gates are labeled on each saved echogram Tapping anywhere on the echogram window opens the Edit Gates screen 3 30 OcuScan RxP Measuring System 7 Continue analyzing and saving echograms until all ten positions in the Readings window have data When all ten positions are full the system automatically returns to the Frozen state and the screen shown in Figure 3 20 appears After all 10 readings are taken the user may review the individual readings using the footswitch By pressing and releasing the footswitch quickly the user can scroll through the readings If the footswitch is held for more
128. t e Lasik This screen allows the user to acquire and save data in a format showing measurements in the four main phases of the Lasik procedure preoperative post flap post ablation and postoperative 1 From the Menu screen tap the Pachymetry button One of the four pachymetry screens appears depending upon the default selection in the Pachymetry Presets The factory default is Single Point as shown in Figure 3 28 Pachymetry Patient Setup If Pachymetry is performed in conjunction with Biometry user entered by selecting Biometry from Main menu then Patient information for both Biometry and Pachymetry is entered on the same screen for both procedures as described in Patient Setup for Biometry earlier in this section If Pachymetry was entered by tapping the Pachymetry button on the Menu screen then patient data is entered as described in step 2 2 Tap the Patient field see Figure 3 28 to enter the Patient Information screen as shown in Figure 3 27 Enter the desired information then press OK to return to the Pachymetry scan screen PATIENT INFORMATION New Patient Patient Name AAA Operator 1 7 Patient List Patient ID Pachymetry Preset Preset 7 o a Figure 3 27 PACHYMETRY PATIENT INFORMATION SCREEN Patient information for patients requiring pachymetry measurements only are entered in this screen 8065750127 3 43 3 44 OcuScan RxP Measuring System 3 Tap the Single Point button to adv
129. t Then the next position lights up and the current measurement from the probe is displayed The user must press the footswitch to freeze the measurement and advance to the next position Auto In Auto mode the position to be measured starts blinking When a valid reading has been taken the system beeps if audio is enabled the readings are shown on the position button and the next position starts blinking If the footswitch is pressed the position backs up and erases the last measured value S Auto Super Auto mode is similar to Auto mode except that a minimum of three valid readings are taken and the shortest reading is displayed Each reading is accompanied by voice confirmation of the measurement In all modes the user can set the next position manually by pressing a position on the screen 6 Tap the Cornea Velocity field input the new value and press OK to accept the change The acceptable range is between 1000 2000 m s with a factory default of 1641 m s 7 Tap the Screen drop down menu and select the default screen that will appear when entering Pachymetry mode There are four selections available Single Point Map 1 Map 2 and Lasik 3 40 8065750127 OcuScan RxP Measuring System The Single Point Screen In this screen a sequence of up to ten numbered positions is displayed allowing the user to take repeated measurements of a single point on the cornea The number of points is set by the user in the Pachymetry Set
130. t their exposure to blood borne pathogens and or other potentially infectious materials In any circumstance wherein the exact status of blood or body fluids tissues encountered are unknown it shall be uniformly considered potentially infectious and handled in accordance with OSHA guidelines Underwriter s Laboratories The OcuScan RxP Measuring System is classified by Underwriter s Laboratories Inc with respect to Electric Shock Fire Mechanical and other specified hazards only in accordance with UL 2601 1 and CAN CSA C22 2 No 601 1 Accessory Equipment Accessory equipment connected to or used with this equipment must be certified according to the respective IEC standard e g IEC 950 for data processing equipment and IEC 601 1 1 for medical equipment Furthermore all configurations shall comply with the system standard IEC 601 1 1 Anyone connecting additional equipment or otherwise causes a different system configuration than provided by Alcon is responsible for continued compliance to the requirements of the system standard IEC 601 1 1 If in doubt consult Alcon Technical Services at 949 753 1393 or contact your local Alcon representative Environmental Issues Follow local governing ordinances and recycling plans regarding disposal or recycling of device components and packaging User Information Environmental Considerations 8065750127 The equipment that you have purchased requires the use of natural resources for
131. tem PROBE CHECK 8065750127 A probe check determines system functionality For biometry the probe check tests probe functionality by measuring the Eye Model axial length The eye model is designed to display traces to simulate peaks for contact cornea anterior of lens posterior of lens and retina with a triangular shape simulating the sclera Biometry Probe Check 1 From the Main Menu tap the Probe Check button The following message appears By entering any of the following options all patient data will be erased If you have a current patient with unsaved data tap the Esc button to go back and save the data then return to the probe check 2 Tap the OK button to advance to the probe check 3 Tap the Biometry button to select the biometry probe check The biometry probe check screen appears as shown in Figure 3 8 4 Verify that Technique is Contact If not tap the Settings field and select Contact mode to measure the eye model located at the back of the system 5 Dipthe tip of the biometry probe in water then place it on the eye model located at the rear of the system Note Other eye models may give results different from those stated here 6 Select Auto mode 7 Press the footswitch and wait for the system to take 10 readings 8 Verify that the echogram has four strong echos representing the cornea C1 front of the lens L1 back of the lens L2 and the retina R 10 27 2005 14 08 V112 Probe Check Settings
132. the setup button and entering the desired value Biasing corneal thickness means either subtracting or adding a number from the actual thickness of the cornea This function is normally used by refractive surgeons prior to surgery to visualize post op corneal thickness and to plan for the surgery As an example for a 640 micron corneal thickness 10 Bias will display as 64 microns 10 ym Bias will display as 630 microns and 20 jm Bias will display as 660 microns Enter the desired values for Flap Thickness range 70 to 200 wm and Residual Bed range 200 to 400 um by tapping inside the respective field in the Lasik Targets frame Tap the OK button to return to the Pachymetry scan screen When prompted to save the preset tap Yes V or No X 8065750127 OcuScan RxP Measuring System PACHYMETRY SCANS The Pachymetry Map screens allow the user to acquire corneal thickness measurements on either eye There are four different types of screens available to perform measurements and save data in the format needed for each specific patient The available screens are Single Point This screen is intended to allow repeated measurements of a single point on the cornea and save them as a sequence of up to ten numbered positions on the screen per eye e Maps 1 and 2 Each screen has up to 25 programmable locations positioned in the general topography of the eye Note Only one of these screens can be used for a particular patien
133. tible power supply or a battery Power frequency 50 60 Hz magnetic field IEC 601000 4 8 3 A m 3 A m Note U is the AC mains voltage prior to application of the test level 1 8 Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Table 1 2 continued on the next page 8065750127 OcuScan RxP Measuring System continued from previous page Immunity Test Table 1 2 Electromagnetic Immunity IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance Conducted RF IEC 61000 4 6 Radiated RF IEC 6100 4 3 3 Vrms 150 kHz to 80 MHz 3 V m 80 MHz to 2 5 GHz 3 Vrms Portable and mobile RF communications equipment should be used no closer to any part of the OcuScan RxP Measuring System including cables than the recommended separation distance calculated from the equation applicable to the frequency to the transmitter Recommended separation distance d 2 1 2VP 150 kHz to 80 MHz d 1 2VP 80 MHz to 800 MHz d 2 3VP 800 MHz to 2 5 GHz where P is the maximum output power rating to the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strength from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range
134. tings screen Map 1 Map 2 Selecting Map 1 or 2 activates the Screen Setup button which when pressed will display the Screen Setup for the selected Map see Figure 3 26 In the Screen Setup you can select which of the 25 available positions will be displayed on the Pachymetry Scan screen for each preset Tapping on a position toggles it between selected or unselected When selected a number appears indicating the position is active and its order in the scanning sequence Pressing the delete button will clear all positions to the unselected state There are two ways to configure the Maps e Using the default map provided tap on the position buttons that you want to disable In this case the sequence will stay the same e Delete all the buttons by pressing the delete button Then touch each button that you want to activate in the sequence that you want to take the measurements The Lasik Screen The Lasik Screen is designed to acquire data during the four main phases of a Lasik procedure Preoperative Post Flap Post Ablation and Post Op 8 Select Map 1 then tap the Screen Setup button The Screen Setup appears as shown in Figure 3 26 Tap a position to toggle between selected and unselected Selected positions display a number indicating the position is active and its order in the scanning sequence Delete Button Tapping this button clears all positions to the unselected state Figure 3 26 PACHYMETRY SCREEN SETUP T
135. ulations should be performed using the OcuScan RxP system only Patient data can be copied to a personal computer PC for backing up and viewing using the Patient Viewer The Patient Viewer is a template that is named PatientViewer exe It is contained on the CD ROM that is shipped with the system Requirements for viewing data on a PC e Original files on the OcuScan RxP must be saved in the PC format In System Setup screen confirm that PC Format is selected in the Save Patient Format field PC System running on Windows 98 ME 2000 or XP NOTE Older versions of Windows may require a service pack upgrade e Create a folder on the PC for storing the patient files Assign a relevant name to the folder such as Patient Files e Microsoft Net Framework must be installed in the PC prior to running the Patient Viewer The Patient Viewer will NOT function properly without this update This program may be downloaded via the internet at http msdn microsoft com netframework downloads 1 While in the download screen Left Click on SDKs Redistributables amp Service Packs from the choices presented in the center of the screen 2 Next Left Click on the latest version of the Net Framework i e NET Framework Version 2 0 Redistributable Package x86 displayed on the screen 3 Then Left Click on the Download button located on the top right hand side of the screen 4 Follow Microsoft s steps to Save it on your PC and then run th
136. user has the choice to enter their optimized constants NOTE R in Haigis Formula is calculated using K1 and K2 But if K s are adjusted normally done for eyes undergone Refractive surgery using K Adjust then K Haigis is calculated for Haigis IOL power calculation 8065750127 OcuScan RxP Measuring System Lens Constant Conversion Table Anterior Chamber Surgeon Factor 30 110 0 3 31 110 1 36 3 25 110 2 41 3 19 110 3 AT 3 14 110 4 53 3 08 110 5 59 3 02 110 6 65 2 97 110 7 10 2 91 110 8 16 2 85 110 9 82 2 80 111 0 88 2 74 111 1 94 2 68 111 2 1 00 2 63 111 3 1 06 2 57 111 4 1 11 2 51 111 5 1 17 2 46 111 6 1 23 2 40 111 7 1 29 2 34 111 8 1 35 2 29 111 9 1 40 2 23 112 0 1 46 2 17 112 1 1 52 2 12 112 2 1 58 2 06 112 3 1 64 2 00 112 4 1 70 1 95 112 5 1 76 1 89 112 6 1 81 1 84 112 7 1 87 1 78 112 8 1 93 1 72 112 9 1 99 1 66 113 0 2 05 1 61 113 1 2 11 1 55 113 2 2 16 1 50 113 3 2 22 1 44 113 4 2 28 1 38 113 5 2 34 1 32 113 6 2 40 1 27 113 7 2 46 1 21 113 8 2 51 1 16 113 9 2 57 1 10 114 0 2 63 1 04 114 1 2 69 98 114 2 2 75 93 114 3 2 81 87 114 4 2 86 82 114 5 2 92 76 114 6 2 98 70 114 7 3 04 64 114 8 3 10 59 114 9 3 16 53 8065750127 Table 1 5 Anterior Chamber Surgeon Factor
137. y Doe Kerry Ford Santos Santos Patient 1D 07 26 03 Operator 1 First Name Rob Kim Date Time 10 24 2005 6 12 27 PM 5 15 2005 6 14 58 PM 10 24 2005 6 12 25 PM 7 26 2005 6 12 36 PM 8 6 2005 6 13 46 PM 10 24 2005 6 09 34 PM 10 24 2005 6 09 48 PM Print Age Preset 1 PATIENT VIEWER WITH PATIENT DATA This screen shows the opening screen of the Patient Viewer after loading patient data NOTE The type of sorting used to organize the patient files depends upon whether the PC uses an NTFS or FAT file system An NTFS system sorts alphanumerically while FAT sorts in the order the files are saved To determine which file system is used on your PC hard drive right click on the drive icon then select Properties The file system type is displayed under the General tab 5 Click on the Patient ID number you want displayed then click the Import Button 6 Click on the System Settings tab near the top of the window to view the language selection and to define the print options for the biometry and pachymetry screens as shown in Figure 3 37 The settings for language selection and print are saved until changed again The Language box allows the user to choose from English Francais Deutsch Italiano Japanese Protugues and Espa ol The Define Print box allows the user to choose to print Biometry Pachymetry or both After the selection has been made click on the Print button The user may also pri
138. y plugged into the rear panel connector If probe is being placed on the eye model then make sure that the tip of the probe was dipped in water Check system configuration Eye type selection Technique Mode Gain Use Contact technique for eye model at the back of the system and low Gain Cannot get measurements in Auto Mode Scan peaks do not meet software criteria Continued on next page Confirm the probe alignment with the eye must be perpendicular and all peaks have sufficient amplitude If some peaks do not have sufficient amplitude then use Forced Freeze Capture or Manual mode Table 5 1 TROUBLESHOOTING CHART This table contains three columns of information The first column labeled Condition or Error Message lists the problem or error message observed The Possible Cause column lists the possible reasons for the problem observed The last column labeled Correction suggests what you can do to correct the problem 8065750127 5 1 CONDITION OR ERROR MESSAGE Cannot obtain measurements in Immersion mode POSSIBLE CAUSE Improper position of probe OcuScan RxP Measuring System CORRECTION Make sure probe tip is 1 5 to 9 8 mm from cornea Align probe to be perpendicular so cornea peaks are clearly displayed and retina peak is going straight up before releasing the footswitch Not able to calculate IOL power Necessary data not entered into system Confirm that Axial Length d
139. z These are auto ranging power supplies that automatically adjust to any voltage within the range NOTE The power cord used to connect the power supply to the wall outlet is shipped with systems for use in the U S A and Canada only For other countries a power cord with appropriate ratings and national safety agency approval must be used Connector from power source plugs Connector from power source plugs into this end of power supply gt into this end of power supply DC voltage connector plugs into rear panel of the system DC voltage connector plugs into rear panel of the system POWER SUPPLY PCM80PS24 POWER SUPPLY PMP130 14 S Figure 2 7 EXTERNAL POWER SUPPLY The OcuScan RxP Measuring System is powered by an external power supply 2 8 8065750127 OcuScan RxP Measuring System KEYBOARDS When entering data into the various data fields the system will display a keyboard on the touch screen as shown in Figure 2 8 The first keyboard shown is the default with lowercase letters The following keyboards are displayed when the circled keys are tapped on the touchscreen Figure 2 8 KEYBOARDS DISPLAYED ON THE TOUCHSCREEN Four keyboards are available to enter patient data 8065750127 2 9 2 10 THIS PAGE INTENTIONALLY BLANK LAST PAGE OF SECTION OcuScan RxP Measuring System 8065750127 OcuScan RxP Measuring System SECTION THREE OPERATING INSTRUCTIONS INTRODUCTION This section of the

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