Alcon OcuScan RxP User manual

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OcuScan® RxP

Measuring System

OPERATORʼS MANUAL

Manufacturer: EU Authorized Representative:

Alcon Laboratories, Inc. Alcon Laboratories (U.K.) Ltd. 6201 South Freeway Boundary Way, Hemel Hempstead Fort Worth, Texas 76134-2099 Hertfordshire, HP2 7UD England 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

2003-2005 Alcon, Inc.

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OcuScan

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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 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.

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 instru

ment 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.

ii 8065750127

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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

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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

iv 8065750127

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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

8065750127 v

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LIST OF FIGURES

FIGURE # NAME PAGE #

Figure 1-1 OcuScan® RxP Measuring System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1.1

Figure 1-2 Mounting Holes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1.4

Figure 1-3 Inserting the Compact Flash Card . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1.5

Figure 1-4 OcuScan® RxP Labels and Icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1.15

Figure 2-1 Front Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2.1

Figure 2-2 Rear Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.3

Figure 2-3 Side Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.4

Figure 2-4 Footswitch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.5

Figure 2-5 Biometry Probe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.7

Figure 2-6 Pachymetry Probe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.7

Figure 2-7 External Power Supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.8

Figure 2-8 Keyboards Displayed on the Touchscreen . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.9

Figure 3-1 Functional Flowchart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3.1

Figure 3-2 OcuScan® RxP Screensaver Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3.2

Figure 3-3 Menu Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3.3

Figure 3-4 System Setup Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3.4

Figure 3-5 Display Menu and Deﬁne Report Pop Up Windows . . . . . . . . . . . . . . . . . . . . .3.6

Figure 3-6 Full Report Printout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3.7

Figure 3-7 Patient Records Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3.9

Figure 3-8 Biometry Probe Check Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3.11

Figure 3-9 Pachymetry Probe Check Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3.12

Figure 3-10 The Biometry Presets Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3.13

Figure 3-11 Immersion Technique . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3.15

Figure 3-12 Lens Constants Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3.19

Figure 3-13 Lens Constant Update Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3.20

Figure 3-14 The Patient Frame . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3.22

Figure 3-15 The Patient Information Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3.23

Figure 3-16 The Clinical History Method Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3.25

Figure 3-17 The Biometry Scan Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3.27

Figure 3-18 Using the Eye Model . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3.28

Figure 3-19 Display of Eye Model Echogram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3.29

Figure 3-20 Biometry Scan Screen: Manual Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3.30

Figure 3-21 Edit Gates Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3.31

Figure 3-22 Biometry Details Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3.34

Figure 3-23 IOL Calculations Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3.35

Figure 3-24 Comparison Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3.38

Figure 3-25 Pachymetry Presets Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3.39

Figure 3-26 Pachymetry Screen Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3.41

Figure 3-27 Pachymetry Patient Information Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3.43

Figure 3-28 Pachymetry Single Point Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3.44

vi 8065750127

Page 7

OcuScan

RxP Measuring System

LIST OF FIGURES (continued)

FIGURE # NAME PAGE #

Figure 3-29 Pachymetry Map 1 or 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3.45

Figure 3-30 Pachymetry Lasik Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3.45

Figure 3-31 The Activesync* Partnership Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3.51

Figure 3-32 Accessing Patient Files Through a USB Connection . . . . . . . . . . . . . . . . . . .3.52

Figure 3-33 Accessing Patient Files Through a Network . . . . . . . . . . . . . . . . . . . . . . . . . .3.53

Figure 3-34 Saving Patient Files to the PC. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3.53

Figure 3-35 The Patient Viewer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3.54

Figure 3-36 Patient Viewer with Patient Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3.55

Figure 3-37 System Settings in the Patient Viewer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3.56

Figure 3-38 Biometry Data in the Patient Viewer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-57

Figure 3-39 Pachymetry Data in the Patient Viewer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3.58

Figure 4-1 Printer Paper Installation

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4.4

LIST OF TABLES

TABLE #

NAME PAGE #

Table 1-1 Electromagnetic Emissions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1.8

Table 1-2 Electromagnetic Immunity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1.8

Table 1-3 Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the

OcuScan® RxP Measuring System . . .1.10

Table 1-4 OcuScan® RxP System Speciﬁcations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1.14

Table 1-5 Lens Constant Conversion Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1.23

Table 4-1 Decontamination of Biometry and Pachymetry Probes . . . . . . . . . . . . . . . . . . .4.3

Table 5-1 Troubleshooting Chart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5.1

8065750127 vii

Page 8

PREFACE

OcuScan

RxP Measuring System

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

Page 9

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 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.

8065750127 1.1

Page 10

OcuScan

RxP Measuring System

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 8065750127

Page 11

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 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).

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.

8065750127 1.3

Page 12

OcuScan

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.

RxP Measuring System

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

Page 13

OcuScan

Ridge faces down when inserting card.

RxP Measuring System

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

ﬁgure.

8065750127 1.5

Page 14

OcuScan

RxP Measuring System

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!

•

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.

1.6 8065750127

Page 15

OcuScan

RxP Measuring System

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.

8065750127 1.7

Page 16

Table 1-1

Electromagnetic Emissions

OcuScan

RxP Measuring System

Emissions Test

RF emissions CISPR 11

Harmonic emissions IEC 61000-3-2

Voltage ﬂuctuations/ ﬂicker emissions IEC 61000-3-3

Immunity Test

Electrostatic discharge (ESD) IEC 61000-4-2

Compliance

Group 1

Class B

Class A

Complies

IEC 60601 Test Level

• +6 kV contact

• +8 kV air

Electromagnetic Environment-Guidance

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.

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.

Table 1-2

Electromagnetic Immunity

Compliance Level

• +6 kV contact

• +8 kV air

Electromagnetic Environment-Guidance

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

Surge IEC 601-4-5

Voltage dips, short interruptions, and voltage variations on power supply input lines IEC 61000-4-11

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

• +2 kV for power supply lines

• +1 kV for input/ output lines

• +1 kV differential mode

• +2 kV common mode

• <5% U in UT for 0.5 cycle)

• 40% U UT for 5 cycles)

(>95% dip

(60% dip in

• 70% (30% dip in U for 25 cycles)

• <5% (>95% dip in UT for 5 sec)

3 A/m

• +2 kV for power supply lines

• +1 kV for input/ output lines

• +1 kV differential mode

• +2 kV common mode

• <5% U

• 40% U

• 70% (30% dip in U

(>95% dip

in UT for 0.5 cycle)

(60% dip in

UT for 5 cycles)

for 25 cycles)

• <5% (>95% dip in UT for 5 sec)

3 A/m

Mains power quality should be that of a typical commercial or hospital environment.

Mains power quality should be that of a typical commercial or hospital environment. If the uses of the

OcuScan

RxP Measuring System requires continued operation during power mains interruptions, it is recommended that the

OcuScan

from an uninterruptible power supply or a battery.

RxP Measuring System be powered

Power frequency magnetic ﬁelds should be at levels characteristic of a typical location in a typical commercial or hospital environment.

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

Table 1-2 continued on the next page...

1.8 8065750127

Page 17

OcuScan

RxP Measuring System

...continued from previous page.

Table 1-2

Electromagnetic Immunity

Immunity Test

Conducted RF IEC 61000-4-6

Radiated RF IEC 6100-4-3

IEC 60601 Test Level

3 Vrms 150 kHz to 80 MHz

3 V/m 80 MHz to 2.5 GHz

Compliance Level

3 Vrms

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.

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

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

RxP Measuring System.

8065750127 1.9

Page 18

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 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

Rated maximum output

power of transmitter

(W)

0.01

0.1

100

Separation distance according to frequency of transmitter

150 kHz to 80 MHz

d = 1.2√P

0.12

0.38

1.2

3.8

OcuScan

80 MHz to 800 MHz

RxP Measuring System

(m)

d = 1.2√P

0.12

0.38

1.2

3.8

800 MHz to 2.5 GHz

d = 2.3√P

0.23

0.73

2.3

7.3

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

Page 19

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 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 1.11

Page 20

Safety Requirements

OcuScan

RxP Measuring System

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 I

X MI X

spta

10 MHz Biometry 0.12 0.21 20 MHz Pachymetry probe 0.51 0.13

X is the derated spatial-peak temporal-average intensity in mW/cm2 (milliwatts

spta

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/cm

• The spatial-peak temporal-average intensity does not exceed 100 mW/cm

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

Peak negative acoustic pressure (MPa) 0.69 0.54 Output beam intensity (mW/cm Spatial-peak temporal-average intensity (mW/cm

) 0.03 0.09

) 0.15 0.57

(10MHz) (20MHz)

1.12 8065750127

Page 21

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 Technical 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 systems 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 if this equipment is serviced by anyone other than Alcon-authorized service personnel. In particular, Alcon shall have no obligation to replace, repair or credit customerʼs 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 1.13

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OcuScan

Table 1-4

OCUSCAN® RxP SYSTEM SPECIFICATIONS

RxP Measuring System

CONSOLE DIMENSIONS

Height: 30.5 cm (12.0 inches) Width: 30.5 cm (12.0 inches) Depth: 27.9 cm (11.0 inches)

WEIGHT Packed Unpacked Console & Accessories 6.62 kg 4.85 kg (14.60 lbs) (10.70 lbs)

ENVIRONMENTAL REQUIREMENTS

Operating Storage

Temperature: 10° C to 35° C -10° C to 55° C 50° F to 95° F -18° F to 131° F

Altitude: -125 m to +2500 m -125 m to +6100 m

Humidity: 30% to 75% 10% to 95%

Noise Level: Sound pressure level does not exceed

44 dbA measured at one meter.

ELECTRICAL CHARACTERISTICS

The instrument automatically sets itself to operate with the

supplied voltage and frequency.

Input AC Voltage/Current: 100-120 V~/200-240 V~, 2A to power supply

Frequency: 50/60 Hz

Input DC Voltage/Current: 24 VDC ±2V with minimum of to console 3.3 A from an external power module.

Insulation Class: Class I, type BF Continuous operation.

SYSTEM PERFORMANCE

Internal Video Display: SVGA 800 x 600 External Video: SVGA

Biometry

Probe frequency: 10 MHz ±1 MHz Theoretical Accuracy: ±0.05 mm Clinical Accuracy: ±0.1 mm Axial Length Range: 15 - 39 mm Gain Range: Adjustable from 40 to 80 dB Memory: Biometry Measurements: 10 per eye Physician Settings: 5 IOL Slots per Setting: 10 (editable) Display: AL (10), average AL, Standard Deviation, Lens thickness, ACD, and Vitreous IOL Formulas: Holladay®, SRK II, SRK T, Binkhorst II, Hoffer Q, Haigis (optional)

Pachymetry

Probe frequency: 20 MHz ±2 MHz Resolution: ±1 µm Accuracy: ±5 µm Measurement Range: 100-350, 400-700, and 300-1100 µm Bias: Actual: Actual measurement Percentage: 0 to 300% Absolute: -999 to 999 µm Gain: Auto adjusting Memory: Single Point: 10 programmable points Map 1 or 2: 25 programmable points LASIK: 3 points in each of four phases Physician settings: 5 Display: 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

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OcuScan

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)

101010

RxP Measuring System

Figure 1-4. OcuScan® RxP LABELS AND ICONS - Shown here are the assorted labels and icons printed on the

console and components.

8065750127 1.15

Page 24

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 = 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 ≥ 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 corrected and the IOL power will change.

1.16 8065750127

Page 25

OcuScan

Rag2 –

AG2 



IOLam =

1336 (1.336R – 0.3333LC – 0.001Tam (16.032R – 4LC + LC x R))

(LC – CA) (1.336R – 0.3333CA

– 0.001Tam (16.032R – 4CA + CA x R))

Tam =

1336 (1.336R – 0.3333LC) – IOLam (LC – CA) (1.336R – 0.3333CA)

1.336 (16.032R – 4LC + LC x R) – 0.001IOLam (LC – CA) (16.032R – 4CA + CA x R)

RxP Measuring System

HOLLADAY VARIABLES :

L: Axial length in mm Lhol: Axial length 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 >13.5, then AG = 13.5 mm

ACDH = 0.56 + Rag -

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)

Formula which gives the refraction value depending on the desired IOLam: Tam = f (IOLam)

8065750127 1.17

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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 K)2 + (0.1 M (23.5 - A)2 (tan (0.1 (G - A)2)) - 0.99166 For Predicted ACD: If A< 18.5, then A = 18.5 If A> 31.0, then A = 31.0 If A< 23, then M = +1 and G = 28 If A>23, then M = -1 and G =23.5

1.18 8065750127

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OcuScan

RxP Measuring System

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 – 2.5 L – 0.9 K + C

C = Correction with respect to original SRK formula where C = 0

C values according to the measured axial length :

If L < 20 mm, then C = 3 If 20

< L < 21, then C = 2 If 21 < L < 22, then C = 1 If 22 < L < 24.5, then C = 0 If L > 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 > 14; Rf = 1 if P ≤ 14

IOL = f(Tam): I = P – (Tam x Rf) where Rf = 1.25 if P > 14; Rf = 1 if P ≤ 14

8065750127 1.19

Page 28

SRK-T FORMULAS :

IOLam =

1336 x (C6 - (0.001 x Tam x C8))

C4 x (C5 - (0.001 x Ta

m x C9))

Tam =

(1336 x C6) - (IOLam x C4 x C5)

(1.336 x C8) - (0.001 x IOLam x C4 x C9)

L = Measured Axial length (mm) Lcor = Corrected axial length (mm) Rcor = Corneal Radius of curvature (mm) K = Average K (D) crwdest = Computed corneal width (mm) ACDT = ACD-Constant from the A-Constant ACDest = Estimated postoperative ACD for patient

Retinal thickness: Rethick = 0.65696 – 0.02029 x L

OcuScan

RxP Measuring System

Lcor = L if L

< 24.2

Lcor = –3.446 + (1.716 x L) – (0.0237 x L2) if L > 24.2

Rcor = 337.5 / K

(with K in diopters)

crwdest = –5.41 + 0.58412 x Lcor + 0.098 x K

SqrootR1 = (Rcor)

– (crwdest)2 / 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 C2 = 0.3333 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 Rcor)

Tam = targeted or desired postoperative refraction (D)

1.20 8065750127

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OcuScan

Rag2 –

AG2 



RxP Measuring System

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 = 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 < -4, or when Aref > +4, user must input vertex distance) Rag = R, if r<7 mm, then Rag = 7 mm AG = 12.5 x (AL / 23.5), if AG > 13.5 mm, then AG = 13.5

ACD = 0.56 +ag -

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)) CQ1 = 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 = (1.336 x Alm x R) - (0.001336 x Aref x Alm x V x R) CQ = CQ3 - CQ2 SF = (((-BQ) - SQRT ((BQ2) - ( 4AQ x CQ)))/( 2 x AQ )) - ACD

8065750127 1.21

Page 30

HAIGIS FORMULAS (optional)

IOL Power for given refraction (DL):

OcuScan

RxP Measuring System

DL = n - n where: z = DC + R

(L-d) n/z - d 1 - RXd DL = refractive power of IOL

= refractive corneal power

RX = desired refraction n = 1.336 - refractive index of aequeous and vitreous nC = 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 (RX) for given IOL power:

R 1 + d

= q-DC where: q = n [n-DL(L-d)]

(q-DC) n (L-d) + d [n-DL(L-d)]

Optical ACD (d):

For AC ≠ 0: d = a0 + a1(AC) + a2(L) For AC = 0: d = [a0 + u(a1)] +[a2 +v (a1)] (L)

where: DC = nC - 1

AC = preoperative anterior chamber depth as measured by ultrasound L = preoperative axial length as measured by ultrasound u = -0.241 v = 0.139 a0, a1, and a2 are constants describing the implant IOL.

IOL Constants a0, a1, and a2: Standard a0 = 0.62467 (A) - 72.434; where A = A constant of the lens manufacturer a1 = 0.4 a2 = 0.1

Optimized In optimized mode, the constants a0, a1 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, a1 and a2. The Haigis Formula works best when optimized

constants are used.

OcuScan

RxP is shipped with Standard constants but user has the choice

to enter their optimized constants.

NOTE: “R” in Haigis Formula is calculated using K1 and K2. But if Kʼs are adjusted

(normally done for eyes undergone Refractive surgery) using K-Adjust then K-Haigis is calculated for Haigis IOL power calculation.

1.22 8065750127

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OcuScan

RxP Measuring System

A CONSTANT (D)

110.0

110.1 .36 -3.25

110.2

110.3

110.4

110.5

110.6 .65 -2.97

110.7

110.8

110.9

111.0

111.1 .94 -2.68

111.2

111.3

111.4 1.11

111.5

111.6 1.23 -2.40

111.7

111.8

111.9

112.0

112.1 1.52 -2.12

112.2

112.3

112.4

112.5

112.6 1.81 -1.84

112.7

112.8

112.9

113.0

113.1 2.11 -1.55

113.2

113.3

113.4

113.5

113.6 2.40 -1.27

113.7

113.8

113.9

114.0

114.1 2.69 -.98

114.2

114.3

114.4

114.5

114.6 2.98 -.70

114.7

114.8

114.9

Anterior Chamber

Depth (mm)

.30 -3.31

.41 -3.19

.47 -3.14

.53 -3.08

.59 -3.02

.70 -2.91

.76 -2.85

.82 -2.80

.88 -2.74

1.00 -2.63

1.06 -2.57

1.17 -2.46

1.29 -2.34

1.35 -2.29

1.40 -2.23

1.46 -2.17

1.58 -2.06

1.64 -2.00

1.70 -1.95

1.76 -1.89

1.87 -1.78

1.93 -1.72

1.99 -1.66

2.05 -1.61

2.16 -1.50

2.22 -1.44

2.28 -1.38

2.34 -1.32

2.46 -1.21

2.51 -1.16

2.57 -1.10

2.63 -1.04

2.75 -.93

2.81 -.87

2.86 -.82

2.92 -.76

3.04 -.64

3.10 -.59

3.16 -.53

Table 1-5

Lens Constant Conversion Table

Surgeon Factor

(mm)

-2.51

A CONSTANT (D)

115.0

115.1 3.27 -.42

115.2

115.3

115.4

115.5

115.6 3.56 -.14

115.7

115.8

115.9

116.0

116.1 3.86 .15

116.2

116.3

116.4

116.5

116.6 4.15 .43

116.7

116.8

116.9

117.0

117.1 4.44 .71

117.2

117.3

117.4

117.5

117.6 4.73 1.00

117.7

117.8

117.9

118.0

118.1 5.02 1.28

118.2

118.3

118.4

118.5

118.6 5.32 1.56

118.7

118.8

118.9

119.0

119.1 5.61 1.85

119.2

119.3

119.4

119.5

119.6 5.90 2.13

119.7

119.8

119.9

Anterior Chamber

Depth (mm)

Surgeon Factor

(mm)

3.21 -.48

3.33 -.36

3.39 -.31

3.45 -.25

3.51 -.19

3.62 -.08

3.68 -.02

3.74 .03

3.80 .09

3.91 .20

3.97 .26

4.03 .32

4.09 .37

4.21 .49

4.26 .54

4.32 .60

4.38 .66

4.50 .77

4.56 .83

4.62 .88

4.67 .94

4.79 1.05

4.85 1.11

4.91 1.17

4.96 1.22

5.08 1.34

5.14 1.39

5.20 1.45

5.26 1.51

5.37 1.62

5.43 1.68

5.49 1.73

5.55 1.79

5.66 1.90

5.72 1.96

5.78 2.02

5.84 2.07

5.96 2.19

6.02 2.24

6.07 2.30

(continued on next page...)

8065750127 1.23

Page 32

(...continued from previous page)

Table 1-5

Lens Constant Conversion Table

OcuScan

RxP Measuring System

A CONSTANT (D)

120.0 6.13 2.36

120.1 6.19 2.41

120.2 6.25 2.47

120.3 6.31 2.53

120.4 6.37 2.58

120.5 6.42 2.64

120.6 6.48 2.70

120.7 6.54 2.75

120.8 6.60 2.81

120.9 6.66 2.87

121.0 6.72 2.92

121.1 6.77 2.98

121.2 6.83 3.04

121.3 6.89 3.09

121.4 6.95 3.15

121.5 7.01 3.21

121.6 7.07 3.26

121.7 7.12 3.32

121.8 7.18 3.38

121.9 7.24 3.43

122.0 7.30 3.49

122.1 7.36 3.55

122.2 7.42 3.60

122.3 7.47 3.66

122.4 7.53 3.72

122.5 7.59 3.77

Anterior Chamber

Depth (mm)

Surgeon Factor

(mm)

A CONSTANT (D)

122.6 7.65 3.83

122.7 7.71 3.89

122.8 7.77 3.94

122.9 7.82 4.00

123.0 7.88 4.05

123.1 7.94 4.11

123.2 8.00 4.17

123.3 8.06 4.22

123.4 8.12 4.28

123.5 8.18 4.34

123.6 8.23 4.39

123.7 8.29 4.45

123.8 8.35 4.51

123.9 8.41 4.56

124.0 8.47 4.62

124.1 8.53 4.68

124.2 8.58 4.73

124.3 8.64 4.79

124.4 8.70 4.85

124.5 8.76 4.90

124.6 8.82 4.96

124.7 8.88 5.02

124.8 8.93 5.07

124.9 8.99 5.13

125.0 9.05 5.19

Anterior Chamber

Depth (mm)

Surgeon Factor

(mm)

Bibliographies:

1. John A. Retzlaff, Donald R. Sanders, and Manus Kraff, Lens Implant Power Calculation, 3rd Edition, Thorofare, NJ: SLACK Incorporated, 1980.

2. Kenneth J. Hoffer M.D., The Hoffer Q Formula: A comparison of Theoretic and Regression Formulas, 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 & Implant Registry 2002 , J Cataract Refract Surg. 2002; 28: 152-174.

LAST PAGE OF SECTION

1.24 8065750127

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OcuScan

Pachymetry Probe

LCD Touch Screen

and Display

Speaker

Compact Flash Card Slot

(shown with card installed)

Removeable Stylus

(inserted in holder)

Biometry Probe

Standby Switch

Internal Printer

(behind paper loading door)

RxP Measuring System

General Description

SECTION TWO

DESCRIPTION

The

OcuScan® RxP Measuring System is a diagnostic tool used by ophthalmic

surgeons for pre and post-operative diagnostic 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.

8065750127 2.1

Figure 2-1 FRONT PANEL - The front panel contains an LCD touch screen, a standby

switch, a speaker, and printer.

Page 34

OcuScan

RxP Measuring System

Front Panel Components (see Figure 2-1)

• 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 conﬁrmation 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.

2.2 8065750127

Page 35

OcuScan

24V

101010 BIO PACH

101010

BIO

PACH

24V

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

•

Power Input Connector

+24 VDC power enters the rear panel through an 8-pin din connector.

•

External SVGA Video Output Connector

The system provides a standard SVGA output connector for an optional monitor.

•

Footswitch Connector

The footswitch connects to this Mini Din connector.

•

Ethernet Connector

The Ethernet interface on the rear panel is used for network connection.

•

USB Connector

The USB bus connection is used to store and retrieve patient data to and from a

PC.

•

RS232 Connector

RS 232 serial communication connects the system to an external PC for service

use.

•

Biometry Probe Connector

Use this connector to plug in the Biometry probe.

•

Pachymetry Probe Connector

Use this connector to plug in the Pachymetry probe.

Figure 2-2 REAR PANEL - The rear panel contains a variety of connectors used to

connect power, handpieces, the footswitch, and accessories.

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OcuScan

Carrying Handle

Eye Model

Flash Card Slot

Flash Card

RxP Measuring System

Flash Card Slot

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.

Eye Model

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 contact 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.

2.4 8065750127

Figure 2-3 SIDE PANEL - The left side of the

contains the Flash Card slot. Compact Flash cards are memory devices that can be used to save patient data or upgrade the system software.

OcuScan

RxP Measuring System

Page 37

OcuScan

Footswitch

RxP Measuring System

Footswitch

The footswitch allows hands free initiation of the system control function.

Figure 2-4 FOOTSWITCH - The

OcuScan

RxP footswitch plugs into the rear panel.

Biometry Footswitch Functions

• 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.

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.

• 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.

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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 thickness 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 1st 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.

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OcuScan

Applicator

Straight Probe

Angled Probe

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 probes 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.

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.

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°).

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External Power Supply

Connector from power source plugs

into this end of power supply

DC voltage connector plugs into rear panel of the system

Connector from power source plugs

into this end of power supply

POWER SUPPLY (PCM80PS24) POWER SUPPLY (PMP130-14-S)

OcuScan

RxP Measuring System

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 Hz. These are autoranging 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.

Figure 2-7 EXTERNAL POWER SUPPLY - The

OcuScan

RxP Measuring System is

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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.

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RxP Measuring System

THIS PAGE INTENTIONALLY BLANK

LAST PAGE OF SECTION

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OcuScan

MAIN MENU

PROBE CHECK

Verify that each probe is functioning properly.

PACHYMETRY

(if option is ins talled)

Perform corneal thickness measurements.

Scan

Scans for 25 points, single point, or Lasik.

BIOMETRY

Perform axial length measurements.

Scan

Biometry

Settings

Three modes available: Manual, Auto, S-Auto

In the scan screen, tap the Settings button to customize the scanning parameters.

Pachymetry

Settings

In the scan screen, tap the Settings button to customize the scanning parameters.

Patient

Information

In the scan screen, tap the Patient button to enter patient data.

Details

A detailed table of ten measurements per eye is displayed.

IOL Calculations

IOL power options are displayed based on selected formulas.

Comparison

Compare IOL calculations with five formulas for three selected IOL's.

Formula Configure

Uses IOL Calculation Formula based on the size of the eye.

PATIENT

RECORDS

Manage patient data.

SYSTEM SETUP

Customize the system to meet your specific needs.

RxP Measuring System

INTRODUCTION

SECTION THREE

OPERATING INSTRUCTIONS

This section of the 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.

8065750127 3.1

Figure 3-1 FUNCTIONAL FLOWCHART - This ﬂowchart shows the sequential functions

of the

OcuScan

RxP Measuring System.

Page 44

OcuScan

RxP Measuring System

SYSTEM POWER-UP

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 bottomhalf 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 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.

System Reset

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.

Figure 3-2

3.2 8065750127

OCUSCAN

appears after the system has been inactive for ten minutes.

RxP SCREENSAVER DISPLAY - The screensaver display

Page 45

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.

Figure 3-3 MENU SCREEN - After the system transitions to the Menu screen the user

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.

can choose from the selections shown here (shown with Pachymetry option installed).

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OcuScan

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 program.

Default Operator:

This drop-down menu allows the user to select from five operators identified in the operator name field.

Operator Name:

The name of each operator is shown here. Tap the field to enter the name of the operator.

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.

Esc:

Exits the system setup without saving changes.

Service Menu:

Entrance to Service Mode-password required.

Video Mode:

Select LCD Only, or SVGA mode to connect to an external monitor.

Display Brightness:

Adjustable between 10 and 100.

Language:

Drop down menu allows the user to select from seven languages.

Date and Time:

Select the desired format, then enter the correct values.

Print/Save Button:

Tapping this button will print a copy of the System Setup screen.

RxP Measuring System

SYSTEM SETUP

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

3 Using the stylus, touch the Clinic box; a keyboard appears on the screen. Using

3.4 8065750127

System Setup.

Figure 3-4 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.

up to 20 characters, type the name of your facility, then press OK. The name of your facility appears in the Clinic box.

Page 47

OcuScan

RxP Measuring System

4 Select the Operator number from the drop down menu, then enter names 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.

5 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.

• MON/DD/YYYY - the month is shown alphabetically (JAN, FEB, etc.), the day and year numerically.

• DD/MON/YYYY - the day is shown numerically, the month alphabetically, and the year numerically.

• MM/DD/YYYY - the month, day, and year are shown numerically.

• DD/MM/YYYY - the day, month, and year are shown numerically.

6 In the Time ﬁeld, select the

Format you desire to have the time displayed in, then

select the current Hour, Minute, and Second.

7 In the

Language ﬁeld select the language you desire on the information screens.

8 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.

9 In the

Display Brightness ﬁeld adjust the optimum video brightness level for the

room environment.

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OcuScan

RxP Measuring System

The Records ﬁeld contains two buttons that set the action of the Print/Save button

that is displayed in most of the working screens. Pressing the top button toggles

The Print/Save

Button

through the following options:

Display menu - Displays the options window shown in Figure 3-5.

• Full Report and Save - Prints a full report (see Figure 3-6) and saves the data

• to the current patient's records (if a Compact Flash card is inserted).

•

Current Screen - Prints the current screen only. 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.

• 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.

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.

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1 24.17

2 24.18 3 24.17 4 24.17 5 24.17 6 24.17 7 24.17 8 24.17 9 24.17 10 24.17 AC: 3.94 L: 4.48 V: 15.75 SD: 0.00 Avg: 24.17

10/20/2005

Operator: Johnson

06:31 V1.12

Patient Name: JONES, PAT

ID: 143262645

Age: 52

Biometry Preset: Dr. Smith

Pachymetry Preset: Dr. Smith

Type: Phakic

AC: 1532 L: 1641 V: 1532

K1: 43.00

K2: 43.50

K: 43.25

K1: 43.00

K2: 43.50

K: 43.25

Avg AL: 24.17 SD: 0.00

AC: 3.89

White To White:

Technique: Immersion

Mode: AUTO

Gain: 64

TA: -0.5

IOL: MA30AC P

Formula: SRK-T

A: 118.40

OS/Left Eye

Emmetropia: 18.85

IOL Power Refraction

17.50

18.00

18.50

19.00

19.50

20.00

20.50

21.00

21.50

0.92

0.58

0.24

-0.10

-0.45

-0.80

-1.16

-1.52

-1.88

C1 C2 L1 L2 R

1mm 11mm 21mm 31mm 41mm

FROZEN

1st 2nd 3rd

IOL: MA60BM P

Formula: SRK-T

A: 118.90

Emmetropia: 19.40

IOL Power Refraction

18.00

18.50

19.00

19.50

20.00

20.50

21.00

21.50

22.00

0.93

0.60

0.27

-0.07

-0.41

-0.75

-1.10

-1.45

-1.80

IOL: MTA4U0 A

Formula: SRK-T

A: 115.30

Emmetropia: 15.92

IOL Power Refraction

14.50

15.00

15.50

16.00

16.50

17.00

17.50

18.00

18.50

1.11

0.73

0.34

-0.06

-0.46

-0.87

-1.28

-1.69

-2.11

MISSION HOSPITAL

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.

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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 minimum 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.

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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:

• Display patients currently saved to the Compact Flash card (if inserted).

• 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 selected, 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.

• Select - Loads the selected patient record, i.e., that patient becomes the current patient. Refer to "

Uploaded Patient Data

" for additional information.

• Esc - Exits the patient records screen without loading a patient.

• Delete - Deletes the selected records.

• 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

Figure 3-7 PATIENT RECORDS SCREEN Tapping the Patient Records button on the main menu displays this screen. The user can select, sort, remove patient records, or refresh the listing from here.

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 selected, then only ﬁles saved in Compact Flash format are displayed.

Patient Setup for Biometry and Pachymetry.

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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:

• System settings that were saved along with patient data will be loaded back into the system.

• All up-loaded settings as well as measurement data will be highlighted in yellow and will only be highlighted on screens that have data.

• All ﬁelds in the Patient Information screen except Patient ID can be modiﬁed.

• If a 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.

• After a patient upload, the user can only delete all the measurements for an eye and not individual ones.

• Date and time when the patient records were last saved are shown.

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OcuScan

RxP Measuring System

PROBE CHECK

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. Dip the 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).

Figure 3-8. BIOMETRY PROBE CHECK SCREEN - This screen is used to verify that

the biometry probe is functioning properly.

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RxP Measuring System

Pachymetry Probe Check

2. Tap the OK button to advance to the probe check.

3. Tap the Pachymetry button to select the pachymetry probe check. The pachymetry probe check screen appears as shown in Figure 3-9.

4. Select Auto mode (if system is not in Auto mode already) and the 300-1100 range for the eye model at back of system.

5. 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.

6. 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.

7. 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 Standard Deviation (SD).

Figure 3-9. PACHYMETRY PROBE CHECK SCREEN - This screen is used to verify

that the pachymetry probe is functioning properly.

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OcuScan

Presets:

Five presets are available to be configured as needed.

Phakic Eye Velocities:

Changes to the standard phakic eye velocities can be made here.

Settings:

Select desired setting from each drop down menu. Each selection is applied to the current preset.

Sequence:

This selection determines 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.

Lens Constants:

Displays the Lens Constants screen.

Keratometer Index:

Available in the Haigis formula option only.

Acquisition Speed:

Three speeds are available: Low, Medium, & High

Validation:

See Validation Menu below.

Name:

Enter Preset name.

Phakic IOL Defaults:

Selecting an entry and tapping Edit opens an edit window where values can be changed.

Age compensation:

Must be set ON to enable Age based velocity compensation for the natural lens.

Validation Menu:

Tapping the Validation Setup

button displays the menu on the

right. 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.

Audio Feedback:

A beep-based feedback signal that increases in speed as the quality of acquisition improves.

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.

1. From the Menu screen, tap the Biometry button to enter the Biometry scan screen.

2. Tap anywhere in the Settings frame. The Biometry Presets screen appears as shown below in Figure 3-10.

Figure 3-10 THE BIOMETRY PRESETS SCREEN This screen allows the user to conﬁgure ﬁve different presets to select from when preparing for a biometry scan.

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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.

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 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 perpendicularity.

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 patientʼs cornea.

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Immersion Shell

Biometry Probe

1.5 to 9.8 mm for auto-trigger

AC L

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.

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.

7. 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.

8. Tap the

Gain ﬁeld. A window opens that allows you to select a new default Gain setting for that preset. The allowable range is 40-80 dB with a system default of 64 dB.

9. 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.

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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

The greater the age of the patient, greater will be the thickness of the lens (greater

compressibility and density) and hence lower the ultrasound velocity1.

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 factory 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 < 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:

Alerts user that the K value is possibly too low. Default limit is set to 40 D but

• user can conﬁgure as appropriate. Alerts user that the K value is possibly too high. Default limit is set to 47 D.

•

Alerts user of larger Kavg variance between eyes. Default limit is set to 1 D.

Jack T. Holladay, MD, MSEE, Standardizing Constants For Ultrasonic Biometry, Keratometry And Intraocular Lens Power Calculations.

JCRS 1997; 23: 1356-1370

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Alerts user when the Corneal Diameter is possibly too low. Default limit is set to

• 11 mm. Alerts user when the Axial Length (AL) measured is possibly short. Default limit

• is set to 22 mm. Alerts user when the AL measured is possibly long. Default limit is set to 25 mm.

• 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. Alerts user of larger AL variance between the eyes. Default limit is set to

•

0.33 mm. Alerts user of variability in AL for the same eye. Default limit for SD is set to

•

0.10 mm. Alerts user of a large variance in IOL power between the eyes. Default limit

• is 1 D. 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. 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 values 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.

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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 displayed 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 A0, A1, 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 Constants 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)

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Lens Parameters:

Tap on a row of values to display the edit box.

Tapping on the Reset Button will restore the factory default IOL and its constants.

Columns A0, A1, and A2 apply to Haigis formula only and will be displayed only if the Haigis formula is installed.

RxP Measuring System

20. Tap the Lens Constant Update button. The Lens Constant Update screen appears

Lens Constant Update Screen

The Lens Constant Update Screen enables the user to customize the A, ACD, and SF

The Lens Update Screen displays the name of the lens for which the constants are

Figure 3-12. LENS CONSTANTS SCREEN - This screen allows the user to make changes

to the default values used for the lens constants.

as shown in Figure 3-13.

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.

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.

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Lens Data:

Tap on a row to display the Add data window.

Select lens

RxP Measuring System

Touching any row of the grid will open the Edit screen or Add screen depending upon

Parameter Range K1 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) ) < -4, or when (SPH + (CYL/2) ) > +4 , the system will

Figure 3-13. LENS CONSTANT UPDATE SCREEN - Lens constants can be updated

here based upon actual patient data.

whether the row has data to edit or it is a new entry. The following parameter ranges are allowed:

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.

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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 excluded 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.

• 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 (SF

+/- 2*SD). If any cases are excluded for this reason, "X" is displayed

avg

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, 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.

21. 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 (√) or No (X). NOTE: Currently unsaved

patient data will be lost if the new settings are saved.

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PATIENT SETUP FOR BIOMETRY

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.

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 was

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.

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New Patient:

Tap this button prior to

entering new patient

information.

Patient List:

Displays the Patient

List showing those

patients in the

currently selected

format; PC or

Compact Flash.

OD/Right EyeOS/Left Eye:

Adjustable parameters for each patient. The K Adjust button opens the K Correction screen where K values can be calculated.

Patient Info:

Tap inside each field to input patient data. A patient ID is required in order to save patient data.

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.

Return Button:

Return to the scan screen.

Print/Save Button:

Tapping this button activates the action selected in the system setup.

SAVE Button:

Tapping this button saves the

patient to the Compact Flash

card in the format selected in

the System Settings screen.

To IOLCALC:

Tap this button to go to

the IOL Calculation Screen

RxP Measuring System

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 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.

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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 have 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.

A1 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.

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Enter values by

tapping on the

associated field.

RxP Measuring System

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 to the current patient's condition.

9. Tap the K Adjust button. The Clinical History Method screen appears as shown in Figure 3-16.

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

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.

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10. Enter the appropriate values for each ﬁeld, then press the Update button to 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.

11. 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

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Patient Frame:

Contains Patient

data. Tap on

screen to open

the Patient

Information screen.

Echogram Window:

Displays an echogram

of the current scan.

Tapping on the window in

frozen state will switch to

the Edit Gates state.

Settings Frame:

Contains current settings. Tap on screen to open the Biometry Presets screen.

Readings:

1s t S ec tion

Captured axial length measurements.

2nd S ection

Anterior chamber, lens, and vitreous measurements for the selected axial length.

3rd S ection

Standard deviation and average axial length.

Menu:

Tap here to return to menu screen.

Previous/Next Screen Buttons:

Use these buttons to move through the screens.

Print/Save Button:

Tapping this button activates the action selected in the system setup.

OD/OS Button:

Tapping this button toggles between the OD and OS eye.

Gain:

Adjust gain from 40-80dB.

Mode:

Tap button to change mode. Available modes are Manual, Auto, and S-Auto.

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.

The Biometry scan shows the axial length measurements of the eye. The screen

The Biometry Screen starts in the

8065750127 3.27

Figure 3-17 THE BIOMETRY SCAN SCREEN - This screen displays the echogram along

contains ﬁelds that display Patient information, the current Settings, Gain adjustment, Mode selection, a graph 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.

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.

with measurement readings for each eye. Patient information and settings are displayed and can be changed by tapping on the frame containing the information.

Frozen state with the word Frozen being displayed

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Eye Model

Biometry Probe

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.

Figure 3-18 USING THE EYE MODEL - 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.

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A live axial length reading is displayed on the echogram during the running state.

RxP Measuring System

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:

• Adjust the gain.

• 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 halfsecond period, the system will return to the Running state without analyzing and saving the reading.

• Go to 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.

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 peaks 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.

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Deleted reading.

Reading(s) farthest from the Avg axial length are pink.

Average axial length of the ten readings.

Delete button- Deletes selected reading. Pressing and holding the button for more than 1 second will display the option to delete all readings.

Cornea1, Cornea2, Lens1, Lens2, and Retina gates are labeled on each saved echogram.

Tapping anywhere on the echogram window opens the Edit Gates screen.

Waveform changes color to match the selected reading.

The first reading clos e st to the Avg axial length is selected. Reading(s) closest to the Avg axial length are green.

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 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.

8. Select a reading from the Readings window by tapping on the reading. The

Editing the Gate Positions If not all required gates can be determined, then that particular reading will be

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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.

echogram for that reading is displayed in the echogram window.

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.

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Selects the next gate.

Accepts changes and returns to scan screen.

Discards changes and returns to scan screen.

Zooms in on the selected gate.

Moves selected gate left or right

- used for fine adjustments.

Reposition selected gate by touching screen at desired location - used for course adjustments.

Selected Gate

Position of edited gate

Axial length, AC, L, and V readings are automatically recalculated as the gate is moved.

SD and Avg values are recalculated as necessary.

Original position of gate

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.

10. Select a gate to reposition by tapping the Gate Select button. Tapping the button

11. Reposition the gate by touching the screen at the desired location. The gate

The echogram may change color depending upon its new relationship to the

• 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

12. Tap the Zoom button. This button enables the user to magnify the selected

Figure 3-21 EDIT GATES SCREEN - In this screen the selected gate can be repositioned

and the associated readings will be automatically recalculated.

again moves the selection to the next 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.

calculated average (Avg) of all the measurements.

because the waveforms were outside the normal software criteria.

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.

13. Press OK to accept the changes or Esc to cancel. The system returns to the normal

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scan screen in the Frozen state.

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Biometry Measurements in Automatic (Auto) Mode

14. Select Auto mode by tapping on the Mode button.

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RxP Measuring System

15. 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.

16. 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 are 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.

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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 additional review by the user to ensure validity.

Biometry Scans in Super-Automatic (S-Auto) Mode

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.

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Reading(s) closest

to the Avg axial

length are green.

Reading(s) farthest

from the Avg axial

length are pink.

Reading(s) taken using

the Force Freeze

function are blue and

use a smaller font.

Average axial length and Standard Deviation of the ten readings.

Tap the Delete button to delete the selected entry.

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 recalculate the Average reading and Standard Deviation for that eye. When the measurement is deleted, it is also eliminated from the Biometry Scan screen.

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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.

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AC and AL values brought forward are the average of the ten readings on scan screen. Values can be edited.

Drop-down menu to enter Target Ametropia. Range is -10 to +10.

Check box can be used to indicate which formula and IOL were used for a particular patient.

IOL and

Formula

selections.

ACD, A, or SF

displayed here.

IOL Power -

nine different

powers in 0.5D

increments.

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 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.

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 one 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.

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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.

21. 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). Nine 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.

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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. 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 patientʼs 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 24.50. 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.

24. 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 IOLʼs 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.

25. Tap the right arrow button to advance to the next screen.

26. 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).

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IOL selections from IOL Calculation screen.

IOL formulas and resulting calculations (Haigis formula is grayed-out if option is not installed).

Tapping the Formula Config button displays the Formula Configuration window shown below.

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 selected for the axial length range specified. The example below shows the Configured IOL Calculation screen for an axial length less than 20 mm.

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RxP Measuring System

Figure 3-24 COMPARISON SCREEN - This screen shows the calculated IOL power

using each of the ﬁve formulas for three different lenses that were 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.

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Preset Number:

Five presets are available to customize the parameters shown on this screen.

Mode:

Set the default scanning

mode to Manual, Auto,

or S-Auto.

Cornea Velocity:

Available range for

default velocity value

between 1000 and

2000.

Volume:

Set the default volume

level for each preset.

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.

Bias:

Select the bias type for each preset from actual, percentage, or absolute. Percentage and absolute values can be changed by tapping the Setup button. Actual is the actual measurement taken with no bias applied.

Audio Feedback:

A beeping-based

feedback signal that increases in speed as the probe approaches

perpendicularity.

Screen:

Set default pachymetry

screen to Single Point

(factory default), Map 1,

Map 2, or Lasik.

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.

Figure 3-25. PACHYMETRY PRESETS SCREEN - This screen allows the user to 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.

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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 measurement.

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.

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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.

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 Settings 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.

• Using the default map provided, tap on the position buttons that you want to disable. In this case the sequence will stay the same.

• 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.

Figure 3-26. PACHYMETRY SCREEN SETUP - This screen allows the user to conﬁgure

which positions will be active during acquisition.

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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. Press the Delete button to clear the current button positions.

10. 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.

11. Press OK to save the changes if desired.

12. Tap the Volume

drop-down menu and select the default volume level for this

preset.

13. 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.

14. 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 µm. The selection made here will be displayed as the default on the Pachymetry Scan screen.

15. 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 µm) values can be changed by tapping 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 µm Bias will display as 630 microns, and 20 µm Bias will display as 660 microns.

16. Enter the desired values for Flap Thickness

(range = 70 to 200 µm) and Residual Bed (range = 200 to 400 µm) by tapping inside the respective ﬁeld in the Lasik Targets frame.

17. Tap the OK button to return to the Pachymetry scan screen. When prompted to save the preset, tap Yes (√ ) or No (X).

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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.

• 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 patient.

• 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, postﬂap, 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

Setup for Biometry

earlier in this section. If Pachymetry was entered by tapping the

Patient

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.

Figure 3-27 PACHYMETRY PATIENT INFORMATION SCREEN - Patient information

for patients requiring pachymetry measurements only are entered in this screen.

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Position Buttons:

Valid readings shown on buttons; blinking button indicates the next position for a reading; pink button indicates reading out of range.

Patient Field:

Tap this field to enter the Patient Information screen.

RxP Measuring System

3. Tap the Single Point button to advance 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.

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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.

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Patient Frame:

Contains Patient

information. Tap in

frame to open the

Patient Information

screen.

Settings Frame:

Contains current settings. Tap on screen to open the Pachymetry Presets screen.

Position Buttons:

Valid readings shown

on buttons; blinking blank,

blue button indicates the

next position for a reading;

blinking 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.

Menu:

Tap here to return to menu screen.

Bias Mode:

Toggles between actual, absolute & percentage bias.

Thickness Range:

Toggles between 100 to 350, 400 to 700 and 300 to 1100.

Screen:

Tap the screen button to toggle thru Maps 1 and 2, Lasik, and Single Point.

Mode:

Tap button to change mode. Available modes are Manual, Auto, and S-Auto.

Readings:

Displays Last, Average, and Minimum readings.

Delete Button:

Deletes the current selection. Pressing the button for more than 1 second will display the option to delete all readings.

Print/Save Button:

Tapping this button activates the action selected in the system setup.

OD/OS Button:

Tapping this button toggles between OD and OS.

Values can be entered for Desired Ablation and Flap Diameter by tapping inside each field.

Position Buttons:

Valid readings shown on buttons; blinking button indicates the next position for a reading; pink button indicates reading out of range.

Procedure Phase:

Scans are organized according to the phase of the Lasik procedure.

Calculations:

Values are automatically calculated for each of the listed categories.

RxP Measuring System

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Figure 3-29 PACHYMETRY MAP 1 or 2 - Maps 1 and 2 can be conﬁgured with up to 25

locations for taking corneal thickness measurements.

Figure 3-30 PACHYMETRY LASIK SCREEN - The Lasik screen allows the user to

organize scans by the four main phases of Lasik surgery.

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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. Ensure that the Pachymetry probe is connected to the rear panel and the Mode button displays Manual.

8. Set the

Bias and Thickness Range buttons to the desired values.

The Bias button allows you to toggle between actual measurements, absolute bias (-999 to 999 µm), 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 µm, 400 to 700 µm, or 300 to 1100 µm.

9. 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.

10. Place the pachymetry probe on the patient's eye.

11. 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

In Auto Mode 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.

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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 taken 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. Herndonʼs table is a modiﬁed version of original conversion factors developed by Dr. N. Ehlers1.

Leon Herndon, MD, Rethinking Pachymetry and Intraocular Pressure, Durham, N.C. Review of Ophthalmology July 2002

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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 button 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

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)

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COPYING PATIENT DATA TO A PERSONAL COMPUTER

CAUTION

The patient data stored on any device other than the

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 calculations should be performed using the

OcuScan

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.

RxP is not validated

RxP system only.

Requirements for viewing data on a PC:

• 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.

• Create a folder on the PC for storing the patient ﬁles. Assign a relevant name to the folder such as “Patient Files.”

• 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 &

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 Microsoftʼs steps to Save it on your PC and then run the .exe ﬁle that

was downloaded.

5 Follow the screen prompts.

• 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.

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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.

2. 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.

3. 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 B USB cable.

1. 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

Wceusbsh.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.

2. 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.

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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 Measuring System.

Note: Older versions of ActiveSnyc require the USB cable to be disconnected and reconnected every time the PC is shut down.

RxP

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 any buttons.

On the PC,

set up a partnership - click "No" then the "Next" button (see Figure 3-31).

Figure 3-31 The ActiveSync Partnership Screen - This screen appears on the PC prior

ActiveSync will appear reporting the connection and ask if you want to

Click "No"

then "Next"

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).

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Click "Explore"

Double-Click "Storage Card"

Double-Click "My Computer"

Double-Click "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, 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.

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Figure 3-33 ACCESSING PATIENT FILES THROUGH A NETWORK - Internet Explorer

browser screen displaying the patient ﬁles 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).

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.

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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.

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.

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Figure 3-36 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 Español.

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 print by pressing the Print button at the bottom of each page.)

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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…”.

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Figure 3-38 BIOMETRY DATA IN THE PATIENT VIEWER – This screen shows the patientʼs

biometry data displayed on a PC using the Patient Viewer.

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11. Click on the Pachymetry tab to view the pachymetry patient data as shown in Figure 3-39.

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

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Alcon OcuScan RxP User manual

Specifications and Main Features

Frequently Asked Questions

User Manual