Alcon OcuScan RxP User manual

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.

OcuScan

RxP Measuring System

OcuScan® RxP Operator's Manual

8065750127

MANUAL REVISION RECORD

DATE REVISION ECN NUMBER & REVISED PAGE NUMBERS

June 2003 A ECN 20033093 - Initial release of operator's manual.

Dec. 2003 B ECN 20033945 - Updated information for the Patient Viewer 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

OcuScan

RxP Measuring System

TABLE OF CONTENTS

SECTION ONE - GENERAL INFORMATION PAGE #

The OcuScan® RxP Measuring System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1.1

Quick Start . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1.2

Installation Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1.3

Installing Optional Software and Updating System Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1.4

Notes, Cautions, and Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1.6

EMC Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1.7

Universal Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1.11

Underwriter's Laboratories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1.11

Accessory Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1.11

Environmental Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1.11

User Information - Environmental Consideration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1.11

Safety Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1.12

Product Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1.13

Limited Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1.13

IOL Calculation Formulas . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1.16

SECTION TWO - DESCRIPTION

General Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.1

Front Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.1

Rear Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.3

Flash Card Slot . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.4

Eye Model . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.4

Footswitch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.5

Probes and Probe Holders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.7

External Power Supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.8

Keyboards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.9

SECTION THREE - OPERATING INSTRUCTIONS

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3.1

System Power-Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3.2

System Reset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3.2

The Menu Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3.3

Using the Touch Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3.3

System Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3.4

Patient Records Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3.9

Probe Check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3.11

BIOMETRY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3.13

Setting up the Biometry Presets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3.13

Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3.14

Phakic Eye Velocities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3.15

Acquisition Speed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3.16

Validation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3.16

Audio Feedback . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3.17

Keratometer Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3.17

Sequence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3.18

Pseudo and Phakic IOL Defaults . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3.18

Lens Constants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3.18

Lens Constant Update Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3.19

8065750127 iii

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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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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.

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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

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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.

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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.

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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)

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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

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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

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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)

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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

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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.

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