OcuScan RxP Operator's Manual Rev F Nov 2005

OcuScan® RxP Measuring System

OcuScan® RxP Operator's Manual 8065750127 MANUAL REVISION RECORD DATE

REVISION

ECN NUMBER & REVISED PAGE NUMBERS

June 2003

A

ECN 20033093 - Initial release of operator's manual.

Dec. 2003

B

ECN 20033945 - Updated information for the Patient Viewer template 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.

Jan. 2004

C

ECN 20042012 - No changes to text; clerical change to assembly drawing.

Oct. 2004

D

ECN 20043577 - Update EMC statement. Changed pages include: i (title) - viii, 1.6 - 1.22, 7.1 - 7.2.

June 2005

E

ECN 20050660 - Updated manual with new information for instrument disposal (WEEE). Changes to pages i, ii, 1-10, 1-14, and 7-1.

Nov. 2005

F

ECN 20051333 - Updated manual with new information for software version 1.12. Changes 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.

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TABLE OF CONTENTS SECTION ONE - GENERAL INFORMATION PAGE # The OcuScan® RxP Measuring System...1.1 Quick Start...1.2 Installation Instructions...1.3 Installing Optional Software and Updating System Software...1.4 Notes, Cautions, and Warnings...1.6 EMC Statement...1.7 Universal Precautions...1.11 Underwriter's Laboratories...1.11 Accessory Equipment...1.11 Environmental Issues...1.11 User Information - Environmental Consideration...1.11 Safety Requirements...1.12 Product Service...1.13 Limited Warranty...1.13 IOL Calculation Formulas...1.16 SECTION TWO - DESCRIPTION General Description...2.1 Front Panel...2.1 Rear Panel...2.3 Flash Card Slot...2.4 Eye Model...2.4 Footswitch...2.5 Probes and Probe Holders...2.7 External Power Supply...2.8 Keyboards...2.9 SECTION THREE - OPERATING INSTRUCTIONS Introduction...3.1 System Power-Up...3.2 System Reset...3.2 The Menu Screen...3.3 Using the Touch Screen...3.3 System Setup...3.4 Patient Records Screen...3.9 Probe Check...3.11 BIOMETRY...3.13 Setting up the Biometry Presets...3.13 Settings...3.14 Phakic Eye Velocities...3.15 Acquisition Speed...3.16 Validation...3.16 Audio Feedback...3.17 Keratometer Index...3.17 Sequence...3.18 Pseudo and Phakic IOL Defaults...3.18 Lens Constants...3.18 Lens Constant Update Screen...3.19 8065750127

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SECTION THREE - OPERATING INSTRUCTIONS (continued)

PAGE #

Patient Setup for Biometry...3.22 OD/Right Eye and OS/Left Eye...3.24 K Values Before Refractive Surgery...3.25 Refractive Error Before Refractive Surgery...3.25 Refractive Error After Refractive Surgery...3.25 Adjusted K...3.25 Biometry Scans...3.27 Biometry Measurements in Manual Mode...3.28 Editing the Gate Positions...3.30 Biometry Measurements in Automatic (Auto) Mode...3.32 Biometry Scans in Super-Automatic (S-Auto) Mode...3.33 Biometry Details Screen...3.34 IOL Calculation Screen...3.35 Comparison Screen...3.36 Formula Configuration Screen...3.37 PACHYMETRY...3.39 Setting Up the Pachymetry Presets...3.39 Settings...3.40 The Single-Point Screen...3.41 Map 1/Map 2...3.41 The Lasik Screen...3.41 Pachymetry Scans...3.43 Pachymetry Patient Setup...3.43 Pachymetry Scans in Manual Mode...3.46 Pachymetry Scans in Auto Mode...3.46 Pachymetry Scans in S-Auto Mode...3.47 Pachymetry Scans using the Single Point Screen...3.47 Pachymetry Scans using the Map Screens...3.48 Pachymetry Scans using the Lasik Screen...3.48 COPYING PATIENT DATA TO A PERSONAL COMPUTER...3.49 Using a Compact Flash Card Reader to Transfer Patient Data...3.50 Transferring Patient Data to a PC through a USB Connection...3.50 Transferring Patient Data to a PC through an Ethernet Network Connection...3.52 Viewing Patient Data on a PC...3.54

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SECTION FOUR - CARE AND MAINTENANCE Maintenance...4.1 Storage...4.1 Cleaning the Console...4.1 Cleaning the Touch Screen...4.1 Taking Care of the Biometry and Pachymetry Probes...4.2 Installing Paper into the Printer...4.4 SECTION FIVE - TROUBLESHOOTING OcuScan® RxP Troubleshooting Instructions...5.1 SECTION SIX - ACCESSORIES AND PARTS OcuScan® RxP Accessories...6.1 OcuScan® RxP Optional Items...6.1 SECTION SEVEN - INDEX Alphabetical Listing of Topics...7.1

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LIST OF FIGURES FIGURE #

NAME

Figure 1-1 Figure 1-2 Figure 1-3 Figure 1-4

OcuScan® RxP Measuring System...1.1 Mounting Holes...1.4 Inserting the Compact Flash Card...1.5 OcuScan® RxP Labels and Icons...1.15

Figure 2-1 Figure 2-2 Figure 2-3 Figure 2-4 Figure 2-5 Figure 2-6 Figure 2-7 Figure 2-8

Front Panel...2.1 Rear Panel...2.3 Side Panel...2.4 Footswitch...2.5 Biometry Probe...2.7 Pachymetry Probe...2.7 External Power Supply...2.8 Keyboards Displayed on the Touchscreen...2.9

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

Functional Flowchart...3.1 OcuScan® RxP Screensaver Display...3.2 Menu Screen...3.3 System Setup Screen...3.4 Display Menu and Define Report Pop Up Windows...3.6 Full Report Printout...3.7 Patient Records Screen...3.9 Biometry Probe Check Screen...3.11 Pachymetry Probe Check Screen...3.12 The Biometry Presets Screen...3.13 Immersion Technique...3.15 Lens Constants Screen...3.19 Lens Constant Update Screen...3.20 The Patient Frame...3.22 The Patient Information Screen...3.23 The Clinical History Method Screen...3.25 The Biometry Scan Screen...3.27 Using the Eye Model...3.28 Display of Eye Model Echogram...3.29 Biometry Scan Screen: Manual Mode...3.30 Edit Gates Screen...3.31 Biometry Details Screen...3.34 IOL Calculations Screen...3.35 Comparison Screen...3.38 Pachymetry Presets Screen...3.39 Pachymetry Screen Setup...3.41 Pachymetry Patient Information Screen...3.43 Pachymetry Single Point Screen...3.44

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LIST OF FIGURES (continued) FIGURE #

NAME

PAGE #

Figure 3-29 Figure 3-30 Figure 3-31 Figure 3-32 Figure 3-33 Figure 3-34 Figure 3-35 Figure 3-36 Figure 3-37 Figure 3-38 Figure 3-39

Pachymetry Map 1 or 2...3.45 Pachymetry Lasik Screen...3.45 The Activesync* Partnership Screen...3.51 Accessing Patient Files Through a USB Connection...3.52 Accessing Patient Files Through a Network...3.53 Saving Patient Files to the PC...3.53 The Patient Viewer...3.54 Patient Viewer with Patient Data...3.55 System Settings in the Patient Viewer...3.56 Biometry Data in the Patient Viewer... 3-57 Pachymetry Data in the Patient Viewer...3.58

Figure 4-1

Printer Paper Installation...4.4

LIST OF TABLES TABLE #

NAME

Table 1-1 Table 1-2 Table 1-3 Table 1-4 Table 1-5 Table 4-1 Table 5-1

Electromagnetic Emissions...1.8 Electromagnetic Immunity...1.8 Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the OcuScan® RxP Measuring System . . .1.10 OcuScan® RxP System Specifications...1.14 Lens Constant Conversion Table...1.23 Decontamination of Biometry and Pachymetry Probes...4.3 Troubleshooting Chart...5.1

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PREFACE 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

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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 into 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 professional 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.

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QUICK START 1. INSTALL THE SYSTEM 1.1 Perform the installation instructions on the next page. NOTE: For detailed setup information, refer to Section Three: Operating Instructions. 2. SYSTEM SETUP 2.1 From the Menu screen, tap (or press) System Setup. 2.2 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. 2.3 Set the action of the Print/Save button using the Records selection. Tapping the button advances through the four selections as follows: Current Screen, Full Report, Full Report and Save, and Display Menu. 2.4 Enter the Date and Time. 2.5 Select a Language. 2.6 Select the Video Mode: LCD only or SVGA mode to connect an external monitor. 2.7 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. 2.8 Tap OK to return to the Menu screen. When prompted, tap the checkmark button to save the changes. 3. SETTING UP THE BIOMETRY PRESETS 3.1 From the Menu screen, tap the Biometry button. 3.2 Tap in the Settings frame to enter the Biometry Presets screen. 3.3 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. 3.4 Change the default Settings as necessary. 3.5 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. 3.6 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. 3.7 Enter your preferred lenses in the Lens Constant screen. 3.8 Tap OK to return to the Biometry Scan screen. When prompted, tap the checkmark button to save the changes. 4. ENTERING PATIENT DATA 4.1 Tap the Patient frame. 4.2 Tap the New Patient button. 4.3 Enter a Patient Name and ID. A patient ID is required to save patient data. 4.4 Select the desired Preset and Operator. These were setup in the previous steps. 4.5 Enter the patient data for each eye. 4.6 Tap the arrow button to return to the Biometry Scan 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. 1.2

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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

From the external power supply unit, plug the 24 VDC power input cable connector into the OcuScan® RxP rear panel (see Figure 2-2).

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.

3

Set the footswitch on the floor and plug its cable connector into the footswitch mini din connector on the OcuScan® RxP rear panel .

4

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.

5

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.

6

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).

7

Place the stylus into the holder on top of the console (see Figure 2-1).

8

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.

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Mounting Holes (4x)

51/2 in.

611/16 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 surface 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

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Ridge faces down when inserting card.

Figure 1-3 INSERTING THE COMPACT FLASH CARD - Insert the Compact Flash card as shown in this figure.

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NOTES, CAUTIONS, AND WARNINGS NOTES: • All data that has been entered or displayed on any screen must be verified 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 constants. 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! • • • •

1.6

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.

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EMC Statement 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: • • • •

Reorient or relocate the other device(s). Increase the distance between the equipment. 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 service 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.

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Table 1-1 Electromagnetic Emissions Emissions Test

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

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.

Voltage fluctuations/ flicker emissions IEC 61000-3-3

Complies

Table 1-2 Electromagnetic Immunity IEC 60601 Test Level

Compliance Level

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

• <5% UT (>95% dip in UT for 0.5 cycle)

• <5% UT (>95% dip in UT for 0.5 cycle)

• 40% UT (60% dip in UT for 5 cycles)

• 40% UT (60% dip in UT for 5 cycles)

• 70% (30% dip in UT for 25 cycles)

• 70% (30% dip in UT for 25 cycles)

Mains power quality should be that of a typical commercial or hospital environment. If the uses of the OcuScan® RxP Measuring System requires continued operation during power mains interruptions, it is recommended that the OcuScan® RxP Measuring System be powered from an uninterruptible power supply or a battery.

• <5% (>95% dip in UT for 5 sec)

• <5% (>95% dip in UT for 5 sec)

3 A/m

3 A/m

Immunity Test

Power frequency (50/60 Hz) magnetic field IEC 601000-4-8

Note: UT is the AC mains voltage prior to application of the test level.

1.8

Electromagnetic Environment-Guidance

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...

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...continued from previous page.

Immunity Test

Table 1-2 Electromagnetic Immunity

IEC 60601 Test Level

Compliance Level

Conducted RF IEC 61000-4-6

3 Vrms 150 kHz to 80 MHz

3 Vrms

Radiated RF IEC 6100-4-3

3 V/m 80 MHz to 2.5 GHz

3V/m

Electromagnetic Environment-Guidance 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 = 1.2√P 150 kHz to 80 MHz d = 1.2√P 80 MHz to 800 MHz d = 2.3√P 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 surveya, should be less than the compliance level in each frequency rangeb. Interference may occur in the vicinity of equipment marked with the following symbol.

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. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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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 maintaining 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 Rated maximum output power of transmitter (W)

Separation distance according to frequency of transmitter (m) 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz d = 1.2√P d = 1.2√P d = 2.3√P

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

100

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

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Universal Precautions Universal precautions shall be observed by all people who come in contact with the instrument and/or accessories to help prevent 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 The equipment that you have purchased requires the use of natural resources for 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 takeback 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. 8065750127

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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 Measurements Statistical analysis of Ultrasound Power Measurements per FDA 510(k) Diagnostic Ultrasound Guidance. Probe

Ispta X MI X

10 MHz Biometry 20 MHz Pachymetry probe

0.12 0.51

0.21 0.13

Ispta X is the derated spatial-peak temporal-average intensity in mW/cm2 (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: • • •

The peak-negative acoustic pressure does not exceed 1 MPa. The output beam intensity does not exceed 20 mW/cm2. The spatial-peak temporal-average intensity does not exceed 100 mW/cm2.

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 Peak negative acoustic pressure (MPa) Output beam intensity (mW/cm2) Spatial-peak temporal-average intensity (mW/cm2)

1.12

Biometry (10MHz) 0.69 0.03 0.15

Pachymetry (20MHz) 0.54 0.09 0.57

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