Zeiss IOLMaster User Manual

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IOLMaster

with Advanced Technology

Software Version 5.4

Documentation set

Content

User manual IOLMaster with Advanced Technology Software Version 5.4

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Microsoft Software License Terms

[LT_XP_PRO_embedded_080807]

Installation of a Network Printer on the IOLMaster

[Network Printer on IOLMaster_180707]

Notes on and conditions of use for the remote maintenance tool

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Enclosure IOLMaster Quick Instructions Version 5.4

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IOLMaster

with Advanced Technology

Software Version 5.4

User manual

Knowledge of this user manual is required for operation of the device. You should therefore familiarise yourself with its contents and pay special attention to instructions concerning the safe operation of the device.

The specifications are subject to change; the manual is not covered by an update service.

document and commercial exploitation or communication of its contents are not permitted. Persons in contravention of this copyright are liable to pay compensation for damages. All rights reserved in the event of granting of patents or registration as a utility patent.

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Trademarks

All names of companies and products mentioned in this manual may be trademarks or registered trademarks. Third party products are cited for information purposes only and this does not represent approval or recommendation of these products.

Carl Zeiss Meditec AG accepts no liability for the performance or use of such products.

 Windows

 SRK

XP is a registered trademark of Microsoft Corporation, Inc.

is a trademark of CTI (Computational Technology Inc.).

 Nero is a registered trademark. Nero InCD is a trademark of Nero AG.

Other brand names, software and hardware names used in these operating instructions are subject to trademark or patent protection. The quoting of product names is for information purposes only and does not constitute a trademark misuse.

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Contents

Page

Trademarks ........................................................................................ 2

Contents............................................................................................. 3

Notes on the user manual ................................................................ 6

Symbols ...................................................................................... 6

Purpose of this documentation.................................................... 6

Accessibility of the user manual................................................... 6

Safety instructions ............................................................................ 7

Compliance with standards and regulations ................................ 7

Instructions for installation and use ............................................. 7

Safe operation ............................................................................ 9

Electrical safety .................................................................. 9

Light emission from the device........................................... 9

Requirements for operation ............................................... 9

Important when using the device..................................... 10

Disposal .................................................................................... 10

Disposal of the product within the EU ....................................... 10

Package contents...................................................................... 11

Warning and information labels on the device........................... 12

Customer’s safety obligations.................................................... 14

Description....................................................................................... 15

Intended use of the device ........................................................ 15

Functional description ............................................................... 15

Overall view .............................................................................. 17

Optional accessories.................................................................. 18

Power isolation transformer for external devices....................... 19

Setting up the device for use..................................................... 20

Installation....................................................................... 20

Electrical connection ........................................................ 21

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Contents

Operation .........................................................................................22

General notes on control........................................................... 22

Operation by touchpad and keyboard .......................................23

Screen layout ............................................................................24

Overview of buttons and shortcut keys...................................... 25

Menu overview .........................................................................28

Options menu ........................................................................... 29

Test eye ...........................................................................29

Lens database .................................................................. 29

Data store ........................................................................31

Setup............................................................................... 34

Network Broker configuration (optional) ..........................43

Preparing for measurements...................................................... 53

Switching the device on ................................................... 53

Patient Manager (New patient)......................................... 53

Adjusting the device to the patient................................... 58

Axial length measurement [ALM] with Advanced Technology ... 59

Axial length measurement [ALM]............................................... 61

Measurement of corneal curvature [KER] ................................... 66

Keratometer measurement............................................... 66

Measurement of anterior chamber depth [ACD] ........................ 69

Determination of "white-to-white" [WTW] (optional)................ 72

Measuring the other eye ...........................................................74

Printout of results...................................................................... 74

Generation of IOL options ......................................................... 75

Filling the IOL database .................................................... 75

IOL calculation .................................................................76

IOL calculation after corneal refractive surgery (optional) .. 79

Calculation of phakic implants (optional).......................... 83

4-in-1 calculation ............................................................. 84

Optimisation of lens constants................................................... 84

Selecting lens data ........................................................... 84

Loading existing data records ...........................................85

Entering new data records ...............................................86

Starting optimisation........................................................ 89

New patient ..............................................................................91

Working with the Patient manager................................... 91

Retrieving a reading from previous measurements............ 92

Deleting a patient/measurement ......................................93

Renaming a patient..........................................................94

Transmitting/exporting data (optional)....................................... 95

Exporting data to another system..................................... 95

Exporting data to a storage medium ................................96

Switching off the device ............................................................ 97

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Contents

Evaluation of ALM results.............................................................. 98

Signal curves of axial length measurements............................... 98

Valid signal curves ........................................................... 98

Recognition of misadjustments on the graph ................... 99

Measuring errors with pseudophakic eyes...................... 100

Zooming the graph display...................................................... 101

Post-run editing of axial length measurements ........................ 103

SNR categories............................................................... 103

Shifting the measuring cursor ........................................ 104

Interpretation of axial length measurements............................ 107

Signals from the inner limiting membrane (ILM) ............. 109

Signals from the choroid................................................ 110

Tips for keratometer measurement ............................................. 112

How to adjust the measuring marks........................................ 112

Measuring errors..................................................................... 113

Misadjustments ............................................................. 113

Other findings ............................................................... 115

Tips for anterior chamber depth measurement.......................... 118

How to adjust the device......................................................... 118

Measuring errors..................................................................... 120

Incorrect settings ........................................................... 120

Pathological findings...................................................... 124

Tips for WTW measurement (optional) ....................................... 126

How to adjust the device......................................................... 126

Troubleshooting...................................................................... 126

Servicing and maintenance .......................................................... 127

Remote maintenance (optional)............................................... 127

Operating the online remote maintenance module ........ 127

Checking the measurement functions ..................................... 128

Axial length measurement and keratometer................... 129

Anterior chamber depth measurements ......................... 129

Verifying WTW measurements (optional) ....................... 130

Printer troubleshooting ........................................................... 131

Care of the device................................................................... 132

Safety inspections ................................................................... 132

Technical specifications................................................................. 133

Manufacturer’s Declaration.......................................................... 138

Abbreviations/Glossary ................................................................ 139

Important for your safety:

Safety instructions.......................................................................

Servicing and maintenance...................................................... 127

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Notes on the user manual

Symbols

The following warning symbols refer to important safety information in this user manual. Whenever you see these symbols, read the accompanying notes carefully. They may warn against possible health risks or fatal injury. Observe all safety notes and information in this manual and on device labels:

Warning

Caution

Type B medical device conforming to DIN EN 60601-1

Caution

Note

Warning

Correct operation of the device is imperative for safe functioning. Please familiarise yourself thoroughly with the contents of this user manual before using the device!

Risk to the user or patient.

Risk of damage to the device.

Disconnect the device from the power supply before servicing.

Information and notes for a better understanding of the operating instructions.

Purpose of this documentation

The purpose of this user manual is to acquaint the user with the design, operation, setup, handling of the device together with the safety, cleaning and maintenance procedures for the system.

Accessibility of the user manual

Always keep this user manual and all accompanying documents in the immediate vicinity of the device. The user manual should be readily accessible at all times.

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Safety instructions

Compliance with standards and regulations

 This device is a Class IIa medical instrument as defined by the

European Medical Device Directive (MDD).

 This device complies with EC Medical Device Directive 93/42/EEC and

the national implementation of this directive in the form of the German Medical Products Act (MPA) (see page 138).

Instructions for installation and use

This device is a high-quality technical product. To ensure perfect and reliable operation, it must undergo a safety inspection once a year.

 The device may not be stored or operated in environmental conditions

other than those prescribed (see

Technical specifications on page 133).

Manufacturer’s Declaration,on

 Do not operate the device:

– in areas subject to explosion hazard – in the presence of inflammable anaesthetics or volatile solvents,

such as alcohol, benzene or similar

 Do not store or use this device in damp rooms. Do not expose the

device to water splashes, dripping water or sprayed water.

 Modifications and repairs, in particular those requiring the device to be

opened, may only be performed by service technicians employed or authorised by the manufacturer.

 The manufacturer accepts no liability for damage caused by

unauthorised access to the interior of the device. Such actions will render all warranty claims invalid.

 This device may only be used with accessories and software supplied

by Carl Zeiss Meditec. Mains-operated accessories must conform to IEC 60950-1 or 60601-1.

 The device may only be operated by instructed and trained personnel.

 In USA this device may only be purchased or ordered by physicians and

ophthalmologists.

 The user manual should always be kept at hand for reference.

 It is also important to comply with the instructions supplied with

accessories.

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Safety instructions

 Use only printers approved by Carl Zeiss Meditec.

– Use only the CD supplied by the printer manufacturer to install

the printer software.

– Prior to using older printers, consult http://support.microsoft.com/

to determine whether printer drivers compatible with the Windows

XP operating system are available and use these.

– Position the printer at least 1.5 m from the patient’s seat at the

device.

– The user should not simultaneously touch the patient and metal

parts of the printer.

– If a Protection Class II printer (without protective earth terminal) is

used, make sure that a power isolation transformer (see page

19)

is connected into the printer power supply cable.

– If a Protection Class I printer (with protective earth terminal) is

used, make sure that it is connected to its own stationary wall socket of the room’s electrical installation or that a power isolation transformer (see page

19) is connected into the printer

power line.

– The required isolation transformer can be obtained from our sales

organisation.

– The power isolation transformer may not be used for printers

whose wattage (power consumption) exceeds the permissible connected load of the power isolation transformer (e.g. laser printers). Such printers must always be positioned outside the range of the patient (1.5 m from the patient’s seat at the device).

– Protection Class II printers (without protective earth terminal)

whose wattage (power consumption) exceeds the permissible connected load of the power isolation transformer may not be used.

 Additional portable multiple sockets or extension cords may not to be

used.

 The electrical supply must conform to IEC 60364-7-710 guidelines. For

USA and Canada only: Single-phase 120 V AC connectors with NEMA 5-15P connector type.

 Do not use a cellular telephone and other devices not complying with

EMC Class B requirements, as its signals may cause the equipment to malfunction. The effect of radio signals on medical devices is dependent on various factors and therefore unpredictable. To avoid electromagnetic interference, the device must be installed and put into operation in accordance with the user manual and using the components supplied by Carl Zeiss Meditec.

 With the exception of compatible printer drivers, the installation of

other software on the system is not permitted! A software routine prevents external (3

party) software from being installed on the

system.

 The IOLMaster may only be connected to private networks which are

protected from public networks (Internet) by firewalls conforming to the latest technical standards!

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Safety instructions

Safe operation

Electrical safety

 The built-in power supply unit is short-circuit-proof and does not

contain any fuses which are accessible from the outside.

 Provided the device is properly used, no electrical hazards exist to

either patients or operators.

 The device may be opened only by persons authorised by the

manufacturer.

Light emission from the device

The limit values as specified for Class 1 laser devices to EN 60825-1 will be observed if the device is operated as intended.

Requirements for operation

Please take care that the following operational requirements are met when using the IOLMaster:

 Use the power cable supplied with the device. If the device is

mounted on an IT 3L instrument table, it will receive its power supply through the table.

 The power supply plug must be inserted into a power outlet that has

an intact protective conductor connection.

 All cables and plugs may be used only if they are in perfect working

condition. In particular, the spring action plug for device control (7,

Fig. 3) must remain plugged in and should not be pulled out.

 If the earth contact is impaired, or if electrical wiring is damaged, the

device must be taken out of service and measures taken to prevent inadvertent use. Following this, call Carl Zeiss Service.

 Do not cover/obstruct ventilation slots in the computer casing (right

and left)!

 If peripheral devices are connected (CRT monitor and/or PC are

possible) the user must ensure that safety requirements of DIN EN 60601-1-1 (medical electrical systems) are observed.

 A network isolator must be inserted for connection to an external

network (NET).

 If either of the error messages "laser fixation power too strong" or

"laser power too strong, measurement interrupted" appears, the device must be shut down. Following this, call Carl Zeiss Service.

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Safety instructions

Important when using the device

 Always enter the patient data (last and first name, date of birth) or

ID Number (depending on setting in Setup menu).

 Pull the power supply cable immediately if damage or unspecified

problems occur!

 Switch off the device as follows:

– Click on the – Confirm with

The program will automatically close; the readings for the last patient will be saved and the device will shut down automatically (lamp in the switch goes off).

Warning

Internal components are still under voltage while the switch lamp is lit, even after the device has been switched off at the power switch! Allpole disconnection of the device has not been achieved until the switch lamp goes off. The lamp must be off before the power supply is unplugged or the device switched off at the main room switch. Failure to observe these instructions may result in loss of data.

EXIT icon on the toolbar.

OK and switch the device off at the power switch.

 The device contains a computer. Please follow the instructions for the

Switching off the device on page 97.

Disposal

The device’s internal control computer contains electronic components and a lithium battery (type CR 2032). At the end of its useful life it must be properly disposed of in compliance with local regulations.

Disposal of the product within the EU

In accordance with applicable EU guidelines at the time at which the product was brought onto the market, the product specified on the consignment note is not to be disposed of via the domestic waste disposal system or communal waste disposal facilities.

For further information on disposal of this product, please contact your local dealer or the manufacturer or its legal successor company. Please read the latest internet information provided by the manufacturer.

Where the product or its components are resold, the seller must inform the buyer that the product must be disposed of in accordance with the currently applicable national regulations.

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Safety instructions

Package contents

The device is delivered completely assembled in foam material packaging. The enclosed accessory box contains the following components:

– Keyboard – Power cable – This user manual – Dust cover – Test eye in its own case – 2x CD/RW (formatted)

Save the original packaging for storing the device during extended periods of non-use or returning it to the manufacturer, or dispose of it properly.

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Safety instructions

Warning and information labels on the device

The device casing carries the following warning and information labels.

Fig. 1 Warning and information labels on the device

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Safety instructions

IOLMaster

000000-1322-734-01-DE-Vs02 MW IB

Carl Zeiss Meditec AG

07740 Jena, GERMANY

100…240 V

50/60 Hz

90 VA

IP20

REF 1322-734

SN XXXXXX

Type label

Manufacturer

Manufacturing date

Application parts type B as per IEC 60601

Identification plate IOLMaster

REF catalogue number/ part number SN serial number

Connection panel

000000-1322-734-04-DE-Vs02

Warning Disconnect the device from the power supply before servicing.

XX/XXXX

REF 1477-889

SN XXXXXX

Complies with 21 CFR Subchapter J

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Warning label Observe all safety notes and information in this manual

"Manufactured" label

Manufacturing date XX/XXXX = Month/Year e.g. 06/2007

Identification plate IOLMaster computer

REF catalogue number/ part number SN serial number

Complies with 21 CFR Subchapter J

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Safety instructions

Customer’s safety obligations

The user is responsible for ensuring that:

 the device is used in accordance with the instructions provided in this

manual.

 deviations from the target refraction are precluded by proper

handling of the device:

– Patient must fixate correctly – Device must be precisely focused for keratometry or anterior

chamber depth measurements.

– Biometry formulae must be properly used – Only adjusted IOL constants may be used

 the device is only used in a perfect operating condition without

functional impairment.

 the user manual and all accompanying documents are maintained in

good condition and kept on or in the immediate vicinity of the device.

 only sufficiently trained and authorised personnel is permitted to

operate, maintain and repair the device.

 all operating personnel receives regular instruction on all issues

concerning the device and its components, that such persons are familiar with the user manual and, in particular, the safety precautions

 none of the warning signs on the system are removed or rendered

illegible.

 the device is inspected daily according to

functions on page

 each day no more than 20 axial length measurements are taken on

each patient’s eye.

 a safety inspection is performed on the device each year (see

page

132), in order to guarantee its perfect operating condition.

128 before any patient measurements are taken.

Checking the measurement

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Description

Intended use of the device

The device is to be used only for the measurement of axial length, corneal radii, anterior chamber depth and optionally for the determination of "white-to-white" of the human eye, as well as for the calculation of the required intraocular lens. Responsibility for using the device other than as intended lies with the user. The device may only be used in combination with accessories delivered by Carl Zeiss Meditec (see Section Please consult Carl Zeiss Service regarding the use of other accessories.

Functional description

The IOLMaster is a combined biometry device for measurements on the human eye required for the preoperative computation of intraocular lens power.

It is capable of fast and precise consecutive measurement of the following eye parameters in one session: axial length, corneal curvature, anterior chamber depth and optionally "white-to-white". All measurements are non-contact, providing excellent patient comfort.

Optional accessories on page 18).

The axial length measurement is based on a patented interference optical method known as partial coherence interferometry (PCI). The displayed results of the axial length measurements are compatible with the ultrasonic immersion measurements of axial length via the use of an internal, statistically verified calculation algorithm. The familiar formulae for IOL calculation can thus be used.

However, the lens constants must be changed for use with the PCI method. Please consult the scientific literature on this subject.

The corneal curvature is determined by measuring the distance between reflected light images projected onto the cornea.

The anterior chamber depth is determined as the distance between the optical sections of the crystalline lens and the cornea produced by lateral slit illumination.

"White-to-white" is determined from the image of the iris. The individual measurement procedures are automated, so that the operator is only required to adjust the device to the patient’s eye and initiate the measurement. For this reason the complex biometry of the eye can be rapidly learnt with the IOLMaster, but should be practised with the greatest of care and attention to detail. Extensive integrated safety features (independent redundant hard and software safety features) ensure maximum safety for both the patient and operator when using the IOLMaster.

The control program for the computer in the device base runs under Windows. A backlit LCD serves to observe the patient’s eye and display

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Description

the readings. The device is controlled by the joystick and computer keyboard with integrated touchpad.

Based on the readings, the program can make suggestions for the choice of intraocular lens strengths. The latter are based on internationally accepted calculation formulae. The Haigis, HofferQ, Holladay, SRK software.

II and SRK®/T formulae are implemented in the

The Haigis-L formula may be used to calculate IOLs after LASIK/PRK/LASEK.

The refractive history or contact lens method may be used to correct the measured corneal radii/refraction following refractive corneal surgery.

Selected phakic implants may be calculated by the "calculation of phakic implants".

An IOL database is likewise implemented. Prior to calculation, the latter must be filled with data for the desired lens.

On the basis of postoperative refraction results, the lens constants entered into the calculation formulae may be optimised (personalised) for each individual user.

Literature on the formulae (in case of specific questions please contact Carl Zeiss Meditec):

• Haigis: http://www.augenklinik.uni-wuerzburg.de/uslab/ioltxt/haid.htm

• HofferQ: HOFFER KJ: The Hoffer Q formula: A comparison of theoretic and regression formulas. J Cataract Refract Surg, 19:700-712, 1993; ERRATA 20:677, 1994

• Holladay: HOLLADAY JT, PRAGER TC, CHANDLER TY, MUSGROVE KH, LEWIS JW, RUIZ RS: A three-part system for refining intraocular lens power calculations. J Cataract Refract Surg, 14:17-24, 1988

• SRKII: RETZLAFF J: A new intraocular lens calculation formula, Am Intra-Ocular Implant Soc J 6:148-152, 1980

• SRK/T: RETZLAFF J, SANDERS DR, KRAFF MC: Development of the SRK/T intraocular lens implant power calculation formula. J Cataract Refract Surg 16 (3):333-340, 1990

• Haigis L: HAIGIS W: Publication in preparation

• Correction of corneal radii/corneal refraction after corneal refractive surgery: HOLLADAY JT: IOL calculations following RK. Refract Corneal Surg 5(3):203, 1989 HOFFER KJ: Intraocular lens power calculation for eyes after refractive keratotomy. J Refract Surg 11:490:493, 1995

• Calculation of phakic implants: vd HEIJDE GL, FECHNER PU, WORST JGF: Optische Konsequenzen der Implantation einer negativen Intraokularlinse bei myopen Patienten. Klin MB1 Augenheilk 192:99-102, 1988 HOLLADAY JT: Refractive power calculations for intraocular lenses in the phakic eye. Am J Ophthalmol 116:63-66, 1993 HAIGIS W: Biometry in complicated situations, 9th Conv. of DGII 1995, Rochels et al (Hrsg.), Springer, 17-26, 1996

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Overall view

Description

Joystick with release button

for adjusting the measuring device horizontally (X, Y) and vertically (Z, by turning) Display

Patient eye alignment and display of results Red eye level marks

Patient eye level needed for optimum measurement Instrument lock knob

Connector panel (see also

Mouse connector (light green)

Keyboard connector (purple)

Keyboard (see also

Optional: Printer (not shown)

Fig. 2 View from doctor's side

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Fig. 9)

Fig. 10)

Description

DVD drive/CD-RW drive

for data storage and software installation Adjustment of headrest

Patient chin rest

Holding pins for paper pads

also used to mount alignment aid (test eye) Patient forehead rest

Aperture for semiconductor diode laser (MMLD)

Device control connector

Fig. 3 View from patient’s side

Optional accessories

 Instrument table IT 3L

 Holding bar for securing the IOLMaster on the instrument table

 Printer

 Keyboard support

 Narrow holding bracket for securing the IOLMaster on the keyboard

support

 Paper pads for patient chinrest

 Power isolation transformer for connection of external accessory units

 Network isolator

 Software option A plus

 Software option B

 Connecting cable for coupling with PC

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Description

Power isolation transformer for external devices

Warning

Always connect all peripheral devices, printers and monitors to the power isolation transformer. No components other than those prescribed for the system may be connected to the power isolation transformer or instrument table. Noncompliance represents a violation of the regulations for use of medical devices under DIN EN 60601-1-1. Likewise excepted are laser printers, as their rated supply voltage usually exceeds the permissible connected load of the power isolation transformer. Position the laser printer outside the patient’s range (1.5 m from the patient’s seat at the device). If the Carl Zeiss IT 3L instrument table is used, the power isolation transformer may be mounted to the underside of the tabletop. It may be secured elsewhere, but not placed on the floor.

Power cable connector with

fuses Power switch

Fig. 4 Power isolation trans-

former, input side

Warning

The IOLMaster should never be operated via the power isolation transformer!

The power isolation transformer is not a constituent part of the IOLMaster.

Instrument connector

Power junction connector

Fig. 5 Power isolation trans-

former, output side 230 V

Fig. 6 Power isolation trans-

former, output side 120 V

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Description

Setting up the device for use

The device must be set up and commissioned by authorised representatives of Carl Zeiss; the latter will also instruct the users on operation of the device.

In general, Carl Zeiss Service will perform the following operations.

Installation

 Remove and unpack box containing accessories.

 Carefully remove the device from the box (The device should not be

lifted or carried by the measuring head!).

 Removing shipping braces:

– Loosen device lock knob (4, – Basic setup: Turn joystick clockwise (one turn) to move the device

upward and pull out the red plate underneath the base axis (patient side).

– Remove red pads from the wheel housing of the device base.

Fig. 2)

Fig. 7 Mounting holding bracket

Secure device with holding bracket

The IOLMaster can be permanently secured with the aid of a holding bracket (3, Fig. 7) Holding brackets with two different widths are available:

– 7 mm holding bracket for securing to the instrument table – 5.5 mm holding bracket for securing to the keyboard support

Caution

The two holding brackets are mounted in the same way. Make sure you use the correct holding bracket. Do not lift or carry the device by the measuring head!

• Tilt the IOLMaster to one side so that it rests on the patient head support.

• Remove the three hexagon socket (Allen) screws (SW3) (1, Fig. 7). The screws may be very difficult to loosen.

Caution

Do not remove any other screws on the base plate! Damage may otherwise be caused to the device.

• Attach the holding bracket with adhesive strips (2, outwards.

• Secure the holding bracket with the three hexagon socket screws. Do not yet remove the protective film from the adhesive strips.

• Set the device upright and place it in the desired position.

• Now lift/tilt the device slightly and remove the protective film

Fig. 7).

(2,

• Bring the device carefully into the proposed position. The adhesive strips will hold immediately. The device can no longer be shifted once it has been brought into position!

Fig. 7) facing

000000-1322-734_GA_GB-US_120608

Description

Electrical connection

• Connect mouse and keyboard.

• Optional: Plug in and secure monitor (VGA) and interconnecting cable (NET/COM 1)!

• Connect power cable.

• Install printer as described in

Caution

Use only printers recommended by Carl Zeiss Meditec! Only one printer may be installed. De-install all surplus printer drivers using menu Setup - Printer. Prior to using older printers, please consult Carl Zeiss Meditec whether the printer is approved for use with the IOLMaster.

Power switch

Power supply plug (~)

Monitor port (VGA)

Mouse port (MOUSE)

Keyboard port (KEYB)

Fig. 8.

6 7 8 9

Printer port (LPT1) External PC port (COM 1) Network connector (NET) USB interface (USB)

Install printer according to

manufacturer’s user manual.

Do not connect it to the

IOLMaster yet!

Start IOLMaster and wait until

New patient is displayed.

Switch on printer and connect it

to IOLMaster (USB/LPT 1).

The Windows installation routine

will be displayed.

Select option "No, not at this

time" and confirm with NEXT.

Insert installation CD for printer

driver and wait for language

selection to appear in selection

window.

Select appropriate language and

confirm with NEXT.

Fig. 9 Connection panel

Warning

If connecting external devices, e.g. an external PC, to the connectors or an external monitor to the VGA connector, the operator must ensure to meet the safety requirements as per DIN EN 60601-1-1 (medical electrical systems)!

A network isolator must be inserted for connection to an external network (NET).

The IOLMaster may only be connected to private networks which are protected from public networks (Internet) by firewalls conforming to the latest technical standards!

When the device is turned on at the power switch, it will run through an internal test. Once this has been completed successfully, the device may be operated. Certain operating parameters are factory set and may be changed in the Setup menu (see page 34).

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If a dialog box for the installation

of additional printer software is

displayed, close this box without

installing another printer.

The windows installation routine

will confirm that installation of the selected printer is finished.

Exit with

Fig. 8 Installing the printer

FINISH.

Operation

General notes on control

The operating system of the device's control computer works in the background. For safety reasons, it is not accessible to the user.

Warning

All attempts to manipulate the operating system are strictly prohibited! In particular, deactivation of the Windows firewall is not permitted!

Windows operating conventions apply analogously to the user interface of the IOLMaster software. This relates to working with a mouse/touchpad, the use of icons, working with dialog boxes and menus, confirmation by double-click, etc.

Note

The system does not support all key combinations of Windows. The special Windows keys that exist on some keyboards are ineffective.

The software uses only a few forced processes. The user may switch freely between the individual modes. For rational working the user is urgently advised to observe the sequence of measurements described from page

In rare cases, Windows error messages may appear on the LC display. This might be the case, for instance, if the program running is affected (mostly by external disturbances).

Multiple safety mechanisms in the instrument’s hardware and software ensure that there is no risk of injury.

Caution

If warning messages appear frequently, the device should be taken out of service and labelled as such. Then call Carl Zeiss Service. The device does not support the submission of automatically generated problem reports to Microsoft!

The device may be operated by:

 using the icons (by cursor, touchpad) or

 keyboard or

 menus.

53 onwards.

Measurements are initiated by pressing the button on the joystick.

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Operation by touchpad and keyboard

Touchpad

Left button

Right button

Operation

Fig. 10 Touchpad control

 Move the cursor by touching the touchpad with your finger and

moving it as desired.

 Single and double clicks are possible by tapping a finger on the

touchpad or pressing the left button.

 To drag the cursor, hold the left mouse button depressed while

moving the finger across the touchpad.

 The right button is only functional for:

– resetting the zoom function (page

101)

– continuous positioning of the measuring cursor while dragging

(see page

Single click Selection of menu, textbox or entry.

Double click OK, confirmation of actions.

104)

Operation of Windows buttons or icons

In addition to program control via touchpad you may also activate certain menus by pressing individual keys or key combinations (see Menu overview on page 28 and Overview of buttons and shortcut keys on page 25 ff.).

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Operation

Screen layout

Menu bar

Display field for measurements of right eye

Display field for video images

Display field for measurements of left eye

Eye

Mode (additionally in ALM mode: number of measurements)

Last name

First name

Icons

System messages/progress bar

98 7 6 5

Fig. 11 Screen layout

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Operation

Overview of buttons and shortcut keys

Icon Key Function Explanations

<N>

<O>

<A>

<K>

<D>

<W>

<I>

<P>

Activates patient data entry screen.

Activates overview mode and light spots.

Activates axial length measurement mode.

Activates keratometer (corneal curvature measurement) mode.

Activates anterior chamber depth measurement mode.

Activates WTW determination (optional)

Activates IOL calculation.

Prints results obtained hitherto

For new patients, input of patient data is essential

Functions in all modes and for every measurement

WTW = white-to-white

Calculation already possible after measurement of one eye

Warning

If connecting external devices, e.g. an external PC, monitor or an external network, the operator must ensure the safety requirements are met as per DIN EN 60601-1-1 (medical electrical systems)!

<S>

<X>

<E>

Sends data Requirement: A suitable

computer must be connected to the serial interface or the IOLMaster must be connected to a network*

Transfers data to CDRW or USB flash drive

Requirement: CD-RW has been inserted into the drive or USB flash drive is connected to USB port.

Exits IOLMaster software and Windows and shuts down the device

Functions in all modes and for every measurement; in case of damage: pull out power supply plug immediately!

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Operation

Key functions without icons

Key Function Notes

Space bar

Joystick button

<DEL>

<M>

Cyclic change of modes: ALM, KER, ACD, WTW

Program continuation/

Activates measurement

Deletes the selected ALM or KER measurement from the list

Briefly inactivates "automatic" function

Restores the last measurement

Effective in ALM mode: prints the image of the selected graph; effective in WTW mode: prints the selected image of the eye.

ALM o KER o ACD o WTW …

In overview mode: change to ALM mode In ALM, KER, ACD and WTW mode

Only in ALM, KER and WTW mode with acknowledgment

Briefly interrupts adjustment aid automatic function in KER mode

Effective only in KER, ACD and WTW mode

ALM: one graph only

WTW: right and left eye

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Operation

Summary of result displays

Display Meaning Notes

axial length

3 measurement (22.55 mm) selected.

Displays measurement curve of this measurement.

SNR: 6.4

Unreliable value SNR displays YELLOW (SNR = signal-to-noise ratio)

Measuring error SNR display RED

Result has been manipulated.

SNR display and SNR (signal-to-noise ratio) beside signal curve

Measuring cursor is positioned above signal peak

"Borderline SNR" (uncertain value) appears above graph. Result should be examined by the user for validity.

"Error!" appears above axial length graph.

* remains displayed even if manipulation has been undone!

Values for the peak below the measuring cursor.

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Operation

Menu overview

Patient

New

Opens dialog box for entry of new patient; entry compulsory

Erase

Deletes patient data

Rename

Renames patient data

Query waiting room...

Export

Exports patient data to CD-RW

Send

Sends data via interface (serial, DICOM oder EMR)

Remark

Edits a comment

Prints measurement table

Print current graph

Prints the selected graph in ALM mode

Print current current WTW images

Prints the current images in WTW mode

Print previev

Displays print preview

Functions

Undo

Undoes last KER/VKT value

Recover

Recovers deleted ALM readings

Overview

Activates overview mode

Axial length measurement

Activates ALM mode

Corneal curvature measurement

Activates KER mode

Anterior chamber depth measurement

Activates ACD measurement

White-to-white determination

Activates WTW determination

IOL Calculation

ALM Settings

Accessible in ALM mode only

Phakic

Aphakic

Pseudophakic silicon

Pseudophakic memory

Pseudophakic PMMA

Pseudophakic acrylate

Silicon-filled eye

Silicon-filled eye, aphakic

silicon-filled eye, pseudophakic

Phakic IOL PMMA (0.2 mm)

Primary piggy-back silicon (SLM 2)

Primary piggy-back hydrophobic acrylate

Options

Test eye

Activates/deactivates measurement mode for test eye

Lens database

Enters and edits user and IOL data

Setup

Adjusts various settings

Date/time

Sets system clock

Program settings

Adjusts program/export/ network/view settings User management/ User manager

Regional settings

Windows routine

Printer

Opens system folder

SW option

Installs/de-installs software options

Update

Installs software update

Carl Zeiss Meditec Teleservice

Opens remote maintenance dialog box

Service

Only for service (password-protected)

Printer setup

Selects printer options

Logout

Logs current user off and opens login window

Exit

Exits application and Windows

About IOLMaster

Displays and prints information on program version

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Operation

Options menu

Test eye

The calibration of the device can be checked with this function (see Section

Lens database

Since the device may be used for the preparation of eye surgery by a number of surgeons, surgeon-specific records may be created. This is performed using the Lens database in the Options menu.

Checking the measurement functions on page 128).

• Click on box for entering surgeon-specific data will appear.

Fig. 13 Please enter password dialog box

Note

LENS DATABASE in the Options pull-down menu. The dialog

When the device is delivered, the Lens database only contains the administrator without any password specifications

Fig. 12 Options menu

Only the administrator is entitled to add or delete users and edit their databases.

Note

Individual users may edit their databases only if password protection has been set. If no password protection was set, the databases are accessible to all users!

If Change password is checked, the administrator may assign himself a password in this dialog box.

• Type in the password in the New password and Confirmation text boxes.

• Confirm your entry with

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OK.

Operation

• To create a new lens database the administrator must open his or her own database by selecting Administrator in the Name list box. A dialog box appears, in which new users may be added.

Fig. 14 Lens database - Administrator dialog box

• Type in the name of the new user.

• If several users share the device it is recommended specifying a password each, which must be repeated in the Confirmation text box.

• You can existing users, you can

• If you wish to delete user data from the database, click on the

ADD the new users you have thus entered. In the case of

SET any changes in the name or password.

ERASE

button after having selected the name in the left window.

• Click

OK to confirm your user entries. The new user is now registered

in the database.

• For the entry of lens data, refer to

Filling the IOL database (page 75 f.).

Note

Should a user forget his or her password, the administrator may assign a new password. To do this, the logged-on administrator must highlight the user in the left box and assign a new password with the

SET command button.

Caution

A forgotten administrator password can only be recovered by Carl Zeiss Service!

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Data store

Backup (creating a backup copy)

Operation

With the used for the optimisation of IOL constants together with the IOL data of all surgeons and corresponding lenses used for the calculation.

Warning

A compressed and password-protected file is created in the CD-RW. Do not attempt to read or manipulate this file using other programs!

The respective measurement readings are saved together with the patient’s personal data, regardless of the set deletion date.

The backup process also includes the tables used for IOL constant optimisation (assignment of surgeon/lens/patient/eye/post-operative data). Additionally, the IOL constants currently used for calculation will be saved for all surgeons.

BACKUP function, you can save to a CD-RW the patient data

Note

If you wish to export data to a CD-RW, you must insert a formatted CD-RW into the drive. The CD-RW must be formatted elsewhere (e.g. office PC) in UDF format. Only the Nero InCD is suitable for formatting in UDF format. Alternatively, use one of the formatted CD-RWs as supplied.

Note

In this way, all critical patient and IOL data can be saved together with the data required for lens optimization. Individual values of axial length, corneal curvature/refractive power, anterior chamber depth, WTW are not saved and may get lost, e.g. in the case of a hard disk fault.

Follow this procedure to create a backup copy:

• In the Lens Database activate Administrator.

• Click the

• Insert a UDF-formatted CD-RW into the drive.

• Confirm with

• It may be necessary to delete existing data on the CD-RW (conform with The data will now be copied to the CD-RW. A progress bar will show the status of the copying process.

• Finally, you will be informed that data backup was successful.

BACKUP command button to initiate the backup process.

OK.

YES). Answering with NO will abort the backup process.

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Operation

Restore

By using the RW to the IOLMaster. Follow this procedure to restore saved data:

• In the Lens Database activate Administrator.

• Click RESTORE.

•

Insert the CD-RW with the latest backup copy; confirm with OK.

• Confirm with YES that all surgeon data currently stored on the IOLMaster is to be copied, together with the respective IOL data and patient data available for optimising the IOL constants. Database data will now be copied from the CD-RW to the IOLMaster. A progress bar will show the status of the copying process.

• Finally, the program will inform you if the restore action was a success.

Note

After backed up data has been restored, the Lens Database will reflect the status at the time of backup. All newly registered patients since this time will be irretrievably lost!

Import

The Import function permits IOL data (name and respective IOL constants) to be transferred back to the IOLMaster from a database saved to CD-RW or USB flash drive (Version 1.1 or later). Imported data may be assigned to one or several surgeons. Prior to import, download the available IOL data from the Internet.

RESTORE function you can retransfer saved data from a CD-

Copy the IOL data to a storage medium

Note

Download IOL data using a PC connected to the Internet and a CD-(RW-) recorder or USB flash drive

Caution

Do not use a network-connected IOLMaster for the download!

• Log into www.meditec.zeiss.com/iolmaster.

• Select Optimized lens constants from More information.

• Follow the prompts now appearing on the screen.

• Save the file (do not select Open!) on the desired storage medium.

• Do not extract the ZIP file!

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Operation

Importing IOL data from the storage medium to the IOLMaster

• In the Lens Database activate Administrator.

• Click on the

• Insert the CD-RW or USB flash drive with the database to be imported and confirm with

IMPORT button.

OK.

Fig. 15 Import of lens constant data dialog box

• Choose the desired lenses; select several lenses with <CTRL> + cursor + click (selected lenses appear highlighted in blue).

• Choose the surgeon (one or more) with

<CTRL> + cursor + click

(selected surgeons appear highlighted in blue); if not already existent, the desired surgeons must be created beforehand.

• Accept with

>>. A progress bar will show the status of the copying

process. The selected lens data will be added to the selected surgeons.

• Close the dialog box with

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OK.

Fig. 16 Setup submenu

Operation

Setup

The Setup submenu contains the following entries:

 Date/Time

Opens the Windows routine for setting the system clock.

 Program settings/Program

– Language: IOLMaster dialogs in German, English or other

languages (change requires system restart).

– Display of visual acuity: Decimal or Snellen. Entry of visual acuity

in Patient data dialog box.

– Database: Storage time of datasets (5 ... 365 days). All figures

between 5 and 365 are possible. 365 days are set at the time of delivery. Data records can be identified or sorted by Name, first name, … or by ID Number.

Caution Please note that when switching from Name, first name… mode to ID Number all data records without an ID Number will not be listed

(entry of an ID is not essential). This also applies analogously to switching from ID Number to Name, first name… if a name was not previously entered.

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Operation

– Keratometer

Display: For displaying during IOL calculation, the specification may be as a Radius or Corneal K's or - Cylinder or + Cylinder. Refractive index: Entry of equivalent refractive index for

conversion of corneal radii to corneal K’s. Enter the refractive index implemented on your keratometer (refer to respective user manual).

– Adjustment aid Keratometer / Anterior chamber depth

Adjustment aid KER: If the

Keratometer, a traffic-light display will appear on measurement of the corneal curvature. When the optimum measurement position for the patient has been reached, the traffic light will change from red to yellow to green. If the upon pressing the joystick knob three measurements will be automatically and consecutively triggered after the best-possible setting for the patient has been made and the traffic light has changed to green. Adjustment aid ACD: If the anterior chamber depth (ACD), a traffic-light display will appear on measurement of the ACD. When the optimum measurement position for the patient has been reached, the traffic light will change from red to yellow to green. If the activated, upon pressing the joystick knob the measurement will be automatically triggered after the best-possible setting for the patient has been made and the traffic light has changed to green.

ADJUSTMENT AID is activated for the

AUTOMATIC KER is also activated,

ADJUSTMENT AID is activated for the

AUTOMATIC ACD is also

Fig. 17 Dialog box Program settings/Program - Keratometer and Keratometer/

Anterior chamber depth adjustment aid

– Printing of IOL calculation data

Choose whether you wish to have the calculated IOL data of both eyes printed on a single page or only one eye per page. In addition, in this field you may enter the name of the clinic to appear on the printout of the IOL calculation. Select

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EMMETROPY IOL if desired.

Operation

 Program settings/Export (requires Option A plus)

Select export settings. Under Identification select the patient identification categories, under Measurement Values the values to be exported, and under File output the corresponding output path. The file name can be freely selected. By convention, the file name may not contain the separators ": / \ ? * ". Data will be saved in (*.csv) text format (separator selectable) and may be read using other applications (e.g. MS Excel):

Fig. 18 Program settings/Export dialog box

 Program settings/Network

Warning

Configuration and changes to the network settings should only be carried out by an experienced network administrator.

– Network information

Here you will find all the key network information such as Computer Name, Working Group, IP and MAC address. Use the

CHANGE NETWORK SETTINGS BUTTON to configure the

IP address.

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Operation

– Serial Port:

Use the Serial Port to exchange data with another PC, or the practice administration system installed on it. Choose old, if the connected office management system only allows import of data of interface software versions 1.01 to 2.02 (patient data, measured values). Choose new (with IOL calc. table) (requires option A plus), if the connected office management system can import all offered data according to interface software version 3.0 and higher. COM speed provides a choice of standard transfer rates in Baud.

– DICOM (requires Option N):

Activate the option box under DICOM (Digital Imaging and Communications in Medicine) to exchange DICOM-standard data with the information system of your hospital. For example, with the help of the DICOM Modality Worklist you can automatically transfer jobs, including all relevant patient data, from the hospital's information system to the IOLMaster. You need to configure the Network Broker to be able to use this option. Access the Network Broker Configuration Tool by clicking

BROKER CONFIGURATION button.

the

Warning

Configuration and changes to the network settings should only be carried out by an experienced network administrator.

– EMR (requires Option N)

If you activate the option button EMR (Electronic Medical Record), you can exchange data with the EMR system of your clinic or practice. To do this, the IP address, the port of the EMR server, the Application Entity Title IOLMaster (free choice of device name for the IOLMaster, but must be unique within the network) and the Application Entity Title EMR (this name must correspond to the one given in the EMR system) must be entered in the relevant text boxes.

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Operation

 Program settings/View

Depending on how your EMR or DICOM system is configured, you can adjust the display of the patient measurements in the 2nd level of the patient tree (patient manager list in database field). Select Accession No. + Date if your system issues a process number. Select Requested ProcedureID + Date if your system uses the examination method-assigned IDs. Otherwise select the Date option.

 Program settings/User management

– System login

IOLMaster and the patient database can be protected by means of a password (acc. to HIPAA). For this purpose, activate the option Operator login with password. A password must contain at least one character.

Fig. 19 Program settings/User management dialog box

Note

The option together with password protection, should not be activated until further users (see below) have been registered and their passwords entered. If you change the Admin password, you are advised to note down the new password, e.g. in the device record book. The user administration system cannot be accessed without the Administrator password! If the password is lost, a number code will be displayed after three unsuccessful attempts. This number code will enable service personnel to reset the device.

OPERATOR LOGIN WITH PASSWORD and screen saver,

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Operation

As soon as you have confirmed the new program settings with OK, a login dialog will appear. From now on the IOLMaster can only be used by logging in with password. The default setting is user Admin with the password 0000 (4x zero) in the User manager. To change the password, select the option Change password, enter your user name and old password and confirm with

Fig. 20 Login dialog box

OK.

In addition, a screen saver with a freely adjustable interval can be activated. The screen saver appears if the IOLMaster has been inactive for longer than the set interval. This prevents unauthorised access to protected patient data.

PASSWORD PROTECTION option offers added protection. If this is

The activated, you will only be able to work with the IOLMaster and its database after logging on again with the password.

Fig. 21 Program settings/User management dialog box

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Operation

– User Manager

Click on the hand side of the User Management in the User Manager permits further users to be registered (with the password to be specified ( deleted (

USER MANAGER button. The dialog box on the left-

NEW button), their

CHANGE PASSWORD) or users to be

DELETE).

Fig. 22 Program settings/User management - User manager dialog box

Each user may be a member of one or more user groups. For this purpose, highlight the respective user. The user groups to which this user belongs are shown in the right-hand window Membership.

The user can be assigned to one of the following user groups by clicking on

ADD:

– The Administrator has unrestricted access rights to User

management, the Lens database (see page

29) and the Setup

menu.

– The Surgeon only has an access right to the respective tab in the

Lens database. This tab is created automatically when the user account is established in the User Manager.

– The Assistant has no right of access to the Lens database.

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Operation

All user groups may enter/rename patient data and perform measurements / calculate IOLs.

Users who are not members of any of the above user groups may work on the IOLMaster in the usual way, but they may not change any of the system settings.

To remove a user from a user group, highlight the name and click on

REMOVE.

Note

The rights of the Surgeon and Assistant user groups in the User Group Administration may be extended to include access to the IOLMaster Setup menu and the deletion of patient data.

 Regional settings

Opens the Windows routine for regional settings.

 Printer

Opens the Windows printer folder. This function is only needed for:

– showing the printer queue – displaying the properties of the installed printer. Here you will find

advice on operating and maintaining the printer

– removing a printer that is no longer required (see also page

21).

 SW option

Installing or de-installing a software option

 Update

To install a new software version from a CD:

– Insert an update CD into the drive. – Click on Update to start the software update installation routine. – Follow the instructions on the screen up to the restart prompt. – Remove update CD from the drive. If the IOLMaster reappears in

New patient mode after restarting, the installation of the software update has been completed.

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Operation

 Carl Ceiss Meditec Teleservice (requires Option T)

Used for remote maintenance of IOLMaster by Carl Zeiss Service (see section Remote maintenance (optional), page 127).

 Service

For servicing purposes and password-protected.

Warning

Unauthorised persons may under no circumstances use the service password. The safety warranty for the medical device will otherwise become invalid!

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Operation

Network Broker configuration (optional)

Note

The Network Broker configuration described on the following pages should only be performed by experienced network administrators.

Fig. 23 Network Broker Configuration Tool, start screen

x Start the Network Broker Configuration Tool by clicking on the

BROKER CONFIGURATION button in the Program setting/Network

menu (see page

37).

x Select the desired language for the configuration instructions and

click

CONTINUE.

Note

Click the obtain assistance at each configuration step. Use the

HELP button in all of the configuration tool windows to

CONTINUE

and BACK buttons to navigate between the individual configuration steps. Click dialog

CANCEL to cancel the configuration

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Operation

Fig. 24 Network Broker Configuration Tool, step 1

You can create a new configuration using the Network Broker Configuration Tool or edit an existing configuration. It is only possible to edit an existing configuration if such a configuration has already been created for the configuration tool to call up. When adapting an existing configuration a backup of the old configuration is automatically made, meaning that configuration can be cancelled at any time without loss of data.

• Once you have selected a task, click on

CONTINUE.

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Operation

Fig. 25 Network Broker Configuration Tool, step 2

• Select the IOLMaster from the list of devices.

• Activate the SOCKET COMMUNICATION option.

(The

FEP COMMUNICATION option is not permitted.)

• Click on

CONTINUE.

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Operation

Fig. 26 Network Broker Configuration Tool, step 3

• Enter the name of the device in the DICOM Application Entity Title field.

This is the name by which the Network Broker communicates with the DICOM Storage Provider and the DICOM Modality Worklist Provider.

Note

The name of the Network Broker must be registered with the provider of the DICOM service. To register a name contact the DICOM network administrator.

Note

If you use inadmissible characters when entering the name, it will be shown in red in the DICOM Application Entity Title box and an exclamation mark will appear to the left of input field.

• Click on

CONTINUE.

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Operation

Fig. 27 Network Broker Configuration Tool, step 4

• Enter the name of the DICOM Modality Worklist Provider in the Application Entity Title field. The address and port via which the provider is contacted must be entered in the Host/IP and Port fields respectively.

Note

To register a name contact the DICOM network administrator.

• A maximum timeout period for the provider can be entered in the Timeout field.

• The

• You can decide whether you wish to select single or multiple entries

• If you have selected the MULTI-SELECTION option, enter the maximum

•

CONNECTION TEST button allows you to check the connection to

the specified host.

MODALITY WORKLIST DIALOG check box allows you to determine

whether a dialog is displayed for the modality worklist.

in this dialog box.

number of selection possibilities in the Maximum box.

Then click on CONTINUE.

Note

By default, the maximum is set to "N". This means you can select the entire list.

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Operation

Fig. 28 Network Broker Configuration Tool, step 5

• Enter the name of the DICOM Storage Provider in the Application Entity Title field.

• The address and port via of the provider must be entered in the

Host/IP and Port fields respectively.

Note

To register a name contact the DICOM network administrator.

• A maximum timeout period for the provider can be entered in the Timeout field.

• The

• Use the SC Scaling Factor to specify whether the image output

• Then click on

CONNECTION TEST button allows you to check the connection to

the specified host.

should be scaled down (not for PDF). Activation of this option is not recommended for the IOLMaster.

CONTINUE.

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Operation

Fig. 29 Network Broker Configuration Tool, step 6

• Enter the name of the Network Broker in the CZM-XML environment in the CZM-XML Application Entity Title text box.

• Under Port enter the port number through which the Network Broker can be addressed for socket communication. The standard value 1042 can generally be used.

• Then click on

CONTINUE.

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Operation

Fig. 30 Network Broker Configuration Tool, step 7

• Enter the name of the IOLMaster in the CZM-XML environmanet in the CZM-XML Application Entity Title text box.

• Then click on

CONTINUE.

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Operation

Fig. 31 Network Broker Configuration Tool, step 8

• Define the "HotKey" button to activate the Storage dialog.

• Activate the check box if the Storage window appears only after pressing the "Hotkeys" and not after every storage request.

SHOW STORAGE DIALOG ONLY ON PRESSING "HOTKEY"

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Operation

Fig. 32 Network Broker Configuration Tool, step 9

• Select the language for the Network Broker application from the Network Broker language list.

• Then click on

• In this last step click on OK to save the configuration settings made

to the configuration file.

If the configuration has been correctly concluded, the Network Broker Configuration Tool will automatically end at this point.

CONTINUE.

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Operation

Preparing for measurements

Switching the device on

• Turn the device on at the power switch (1, Fig. 9). The device will start automatically and perform a self-test, after which the Patient manager screen will appear (

• After switching on the device will prompt a daily calibration check prior to patient measurements.

• After confirming with described on page

128.

Warning

Axial length [ALM], corneal curvature [KER], anterior chamber depth [ACD] and white-to-white [WTW] should never be measured through contact lenses as this produces incorrect results.

Fig. 33).

OK check the measurement functions as

Patient Manager (New patient)

The Patient manager manages all existing patient data and the admission of new patients (see Fig. 33; for working with existing patients see page 91). New patients can be entered manually in the patient manager or be imported from via the DICOM or EMR interface from the waiting room.

Search line

Enter patient details (mand.)

Enter refraction and visual acuity data (optional)

Remarks window (optional)

Database window

Fig. 33 New patient dialog box

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Operation

Patients who have been imported via the EMR or DICOM interface from the waiting room into the database are indicated by the "person on network" symbol in the database field. The person is shown in blue if measurements are already available. The colour is grey if no measurements exist yet.

Import of patient data via DICOM interface (optional)

For hospital operation, patient data in DICOM format can be imported directly from the DICOM modality worklist of the hospital network server.

To call up patient data from the waiting room via the DICOM interface, the

DICOM option must be activated in the menu Options Æ Setup Æ

Program settings/Network (see page

must be configured accordingly (see section Network Broker configuration on page

43 ff.).

36 f.) and the Network Broker

• Select Patient Æ Query waiting room… in the New Patient input window.

Fig. 34 Network Broker/Patient based query dialog box

The Network Broker input window opens.

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Operation

The number of patients shown can be limited using the four filter criteria Patient ID, Patient Name, Accession number and Requested Procedure ID on the Patient Based Query tab. When entering the search criteria you can use the character * as a wildcard parameter for any character. To separate the first and last name use the caret symbol ^. If you leave any box empty, no filter will be applied for this element. If you leave all four boxes empty the entire patient list will be shown.

Fig. 35 Network Broker/Broad query dialog box

On the left side of the Broad Query tab you can use the >Modality search box to search for patients for a specific device (modality). The options on the right can be used to restrict the query period. If you leave these boxes empty the entire patient list will be shown.

In both tabs, start the query by clicking

CANCEL. Use RESET FIELDS to reset all query boxes to their standard

values.

• Enter the desired search criteria in the appropriate boxes and start the query by clicking

• Select the patients to be imported from the patient list shown.

EXECUTE.

EXECUTE, or cancel by clicking

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Operation

Use the SELECT ALL button to select the entire patient list, INVERT

SELECTION

entries.

to invert the selection and CLEAR SELECTION to deselect

• Click

The patient data from the waiting room will now be imported into the local database of the device.

Import of patient data from a practice administration system (EMR system, optional)

Data of patients to be examined with the device can also be imported directly from the patient list in the practice management system.

To call up patient data from the waiting room via the EMR interface, the

EMR option must be activated in the menu Options Æ Setup Æ

Program settings/Network (see page

• Select Patient Æ Query waiting room… in the New Patient input

The patient data from the waiting room will now be imported into the local database of the device.

OK to confirm the import of the selected data.

36 f.) and correctly configured.

window.

Note

The patient list will be combined with the patient data to be imported in the office management system. No search criteria or queries are possible with the device software.

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Operation

Manual patient input

If you cannot import the data of a new patient from an existing information system via the DICOM or EMR interface, you must enter this patient's data manually.

Patients entered manually in the database are labelled in the patient manager list with a symbol showing a blue man on an index card.

To register a new patient manually, proceed as follows:

The personal data of patients not yet listed in the database (New patient) must be entered into the text boxes on the right-hand side of the

New patient dialog box via the keyboard. No special

characters other than "-", ".", " ’ ", "_" are permitted.

To move the text cursor to the next dialog box press the key or click the mouse.

Note

Depending on the program setting (see page either the last and first name (case-sensitive) and date of birth or an ID Number is mandatory. The date of birth will be accepted depending on the Windows setting; the year may also be entered as a four-digit number (yyyy)

- mandatory for patients over a hundred years old!

Note

It is recommended that the patient’s refraction data, if known, be entered in the respective boxes. Visual acuity data can only be entered in the data format set in Program settings (see page

Up to 255 characters may be entered in the Remark field (comments, diagnoses, etc.).

TAB or ENTER

34), the entry of

34).

The following special characters

are permitted for entering

patient data:

Minus

Dot

Apostrophe

Underline

Note

Refer to page

91 for working with the database field. In Program Settings you can set the number of days after which a data record is automatically deleted (5 to 365 days).

• To close, after entering the date of birth click on the press the

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ENTER key.

NEW button or

1 2

Operation

This will automatically activate the Overview [OVW] mode. The fixation light and light spots will be switched on. The patient will see a yellow fixation light in the centre and six light spots (reflex points in the patient’s pupil) will appear in the video image.

Circle of light spots for

focusing Cross hairs

Fig. 36 Video image with

correctly set device

• Press the

NEW PATIENT button to open the New Patient dialog box

in the measurement mode.

• Press the

EXIT icon in Patient Manager to quit the program and

Windows.

Adjusting the device to the patient

The two red ring marks (3, Fig. 2) on the side rails of the headrest are for rough vertical adjustment of the chin rest, (3, eyes should be level with these marks.

In Overview mode, align the device to the patient’s eye using the joystick (1,

Fig. 2) Turn the control knob for vertical adjustment. Tell the

patient to look steadily at the fixation point in the centre.

Adjust the device-to-patient distance until the 6 light spots (1, appear focused. If possible, the 6 light spots should be centred on the cross hairs and the edge of the pupil/iris structure should appear in focus.

The position of the device in relation to the patient’s eye thus found serves as a starting point for fine adjustments to be made in the respective measurement mode.

Fig. 3).The patient’s

Fig. 36)

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Operation

Axial length measurement [ALM] with Advanced Technology

The IOLMaster with Advanced Technology features superior signal processing in axial length measurement mode compared to the IOLMaster without this technology. In many cases this enables an overall evaluation of individual axial length measurements (composite signal), producing an axial length result without the need for manual evaluation as described on page determined where this would not have been possible from individual readings. The IOLMaster displays the single signal of the axial length measurement in red and it is marked with an S on the ordinate. The SNR (signal-noise ratio) is shown on the x-axis. In contrast, the composite signal is shown in blue and marked with a C on the ordinate. The increased SNR of the composite signal is likewise shown on the x-axis.

The SNR ranges

– "Measuring error" = red – "Uncertain value" / "Borderline value" = yellow – Value with good SNR = green

are signalised by a traffic light.

Axial lengths are measured with the IOLMaster with Advanced Technology in the customary manner, or as described on page

98. In some cases the axial length can even be

61.

Measuring Uncertain Value with error value good SNR

Take at least five individual measurements. The axial length measurement signal for the first four measurements is displayed as usual immediately after the measurement. From the fifth individual measurement, the composite signal is calculated in the background. After each individual measurement the axial length signal (red) is thus first of all briefly displayed for about 1 second. This is followed by the display of the composite signal (blue). In addition, insofar as it could be determined, the axial length measurement of the composite signal is displayed below the horizontal bar in the list of measurements.

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Operation

If no axial length reading could be determined after the first five individual measurements, additional measurements should be taken. With stronger lens opacities, it may be advisable to defocus the device. You may choose a reflection as large as the circle on the display. Also try measurements by height variation (turning the joystick) of the refocused reflection at the lower and/or upper edge of the circle on the display.

Warning

Ensure that the device permits no more than 20 measurements per eye and day.

Do not delete any single measurements, e.g. because they have a very low SNR or no axial length measurement could be determined from the single signal alone (SNR with "!" or "--"). Even a noisy signal may contain usable information on axial length that can be used for calculating the composite signal. The new technology of the IOLMaster Advanced Technology is based precisely on the evaluation and use of information from all single measuring signals. This eliminates the need for post-run editing of the single signals. They should only be consulted if the composite signal has multiple peaks. In this case post-run editing may be advisable, taking into account the single signals and axial length of the other eye.

The overall axial length measurement is post-run edited as described on

103 onwards.

page

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Axial length measurement [ALM]

Activate the ALM mode by:

Operation

• clicking on the

• pressing key A, or

ALM icon or

• pressing the button on the joystick in Overview mode [OVM].

Switching to ALM mode will automatically change the magnification ratio: a smaller section of the eye becomes visible with the reflection of the alignment light and a vertical line (1, Fig. 37).

• The patient should look at the red fixation point in the centre. A crosshair (3,

Fig. 37) with a circle in the middle will appear on the

display.

• Fine-align the device so that the reflection of the alignment light

Fig. 37) appears within the circle.

(2,

Warning

The patient should be asked if he or she sees the fixation point. If the patient fails to fixate properly, the visual axis will not be correctly recognised, which may result in measuring errors. Measurements should not be taken while a patient is wearing contact lenses, as this will result in measuring errors.

• Trigger the measurement by pressing the knob on the joystick.

Vertical line

Reflection of alignment

light Cross hairs

Fig. 37 View prior to axial

length measurement

The axial length of the single measuring signal will be shown in the respective display panel next to the video image. A red graph will be superimposed on the video image, similar to that familiar from ultrasonic devices. The signal-noise ration [SNR] will be displayed simultaneously as a value. This value is a gauge of the quality of measurement. Measurements with an SNR between 1.6 and 1.9 appear with an exclamation mark (!) after the reading and the message "Borderline value!" (uncertain value) will appear.

Readings in the series of measured values that deviate from the internally calculated composite value by more than 50 μm are shown in red and marked “multiple peaks”. If the SNR is below 1.6, no reliable axis length can be determined from the single measuring signal. In this case dashes "--" are shown.

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Operation

Note

"Borderline value!" does not necessarily mean that the reading is incorrect and must be rejected. It rather means that all axial length measurements for the eye should be checked for plausibility and consistency and compared with the reading, e.g. according to the usual ultrasonic biometry criteria. If the "uncertain" values are determined to concur with the other readings, the readings marked "Borderline value!" should also be accepted as valid axial lengths. Do not delete any single measurements, e.g. only because they have a very low SNR or no axial length measurement could be determined (SNR with "!" or "--"). Such signals can also contain usable information on axial length for use in the calculation of the composite signal.

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Operation

Note

The IOLMaster requires five measurements to be taken! The message measure again will thus appear. Only then will the composite signal be calculated and displayed as a blue measurement curve following the red individual measuring signal. If an axial length measurement can be determined from this composite signal, it will be transferred to the IOL calculation and an evaluation will be performed. Only the number of measurements is crucial here. To obtain consistent results we recommend checking the individual axial length measurements and carrying out further measurements if necessary.

With stronger lens opacities, it may be advisable to defocus the device. You may choose a reflection (2, display. If measurements are even now impossible, the device can be refocused and the reflection shifted to the bottom and/or top margin of the circle on the display by varying the vertical adjustment (turning joystick).

Fig. 37) as large as the circle on the

Note

Defocusing and shifting the reflection within the circle will have no effect on the result, because interferometric axial length measurement is completely independent of distance.

• For the next measurement of this eye, press the button in the joystick.

Warning

Up to 20 such measurements per eye may be taken on a single day. Avoid measurements of eyes with retinal detachment. In such cases, measuring errors cannot be precluded. As a rule, the axial length should be viewed together with the values for corneal refraction and overall refraction, and checked for plausibility. It is likewise helpful to compare the right and left eyes.

The composite signal is calculated after the fifth measurement. Initially, the individual signals are displayed in red. After a delay of about 1 second the composite signal is then displayed in blue. In addition, the axial length reading determined from this composite signal will appear. The composite signal will be re-calculated after each further individual measurement, and an axial length calculated therefrom. Should a reading deviate from another by more than 0.05 mm, it will be displayed in red and the message "Multiple peaks" will appear. This indicates that the individual measurements should be scrutinised and the composite signal may need to be post-run edited (see editing of axial length measurements, page

103 ff.).

Post-run

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Operation

Until an axial length can be determined from the composite signal, the word Evaluation! will be displayed below the horizontal line in the list of measurements. This warning will also be issued if a significant axial length could be determined from a single measurement, but this information is not contained in any further single measurement. If the warning "Multiple peaks" appears, certain axial lengths from the single measurements deviate from each other by more than 50 μm. In this case the axial length from the composite signal (blue) should be viewed with the axial lengths from the single measuring signals (red) in conjunction with the values for corneal refraction and checked for plausibility. It is also advisable to include the axial length of the other eye in the consideration. If no reading can be determined from the composite signal, no value will be transferred to the IOL calculation and database for constant optimisation. Until the fourth individual measurement has been taken, the last reading will be highlighted in blue. From the fifth individual measurement onwards, the composite signal is highlighted in blue. The blue highlighting can be moved through the table of individual readings with the aid of the cursor

buttons np. In this way the signal curves of the individual measurements can be displayed. Deleted individual measurements can be restored with Functions/Recover. The composite signal can be displayed by clicking on the composite reading.

"--" in the display field denotes readings with an SNR smaller than 1.6.

The following plausibility tests are performed with the axial length measurement (AL) from the composite signal:

AL < 22 mm (indication of short ocular axis) AL > 25 mm (indication of long ocular axis)

When both eyes have been measured, the difference in axial lengths between right and left is also checked. If the latter exceeds 0.3 mm, a message appears to check the readings once again.

If this warning appears, be sure to verify that no pathological changes have occurred in the eye. If necessary, the measurements must be repeated (provided the maximum of 20 measurements per eye and day has not already been reached). Only confirm the warning with are certain that the readings are plausible. Otherwise, determine what has caused the implausible readings. A reference to the displayed plausibility test message will be transferred to the comments box.

OK if you

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Operation

The number of measurements of the respective eye taken on this particular day is displayed in the Mode field of the status bar next to "ALM". If the count reaches 20 no further measurements of this eye can be taken on this day. The counter cannot be reset. Deleted readings (see above) do not affect the measurement counter!

Fig. 38 Video image after axial length measurement

ALM of non-phakic eyes

To measure non-phakic eyes, select the corresponding mode from the AL settings menu. This special AL mode is displayed in the video image field and will be active until you reset it via the menu. The device will also be reset to phakic mode if you change to the patient’s other eye or a new patient.

If the axis length of eyes with phakic implants not listed in the additional AL settings is to be measured, the following compensation values according to PD Dr Wolfgang Haigis of Würzburg University Clinic, Germany, should be used.

IOL centre

thickness

IOL material

Silicon 3 (SLM2)

PMMA

Acrysof

0.2 mm 0.5 mm 0.8 mm

-0.02 mm -0.04 mm -0.07 mm

-0.02 mm -0.06 mm -0.09 mm

-0.03 mm -0.08 mm -0.13 mm

Every implant, e.g. a phakic IOL, influences the measurement of axial length in PCI biometry. If a phakic implant is measured in a normal phakic mode, the result will be slightly elevated. The reading must be corrected, depending on the material used and the centre thickness.

Fig. 39 AL settings

Sample calculation for a phakic implant (Acrysof) with a centre thickness of 0.2 mm:

Measured value: 23.51 mm Compensation value: -0.03 mm Correct axial length:

23.51 + (-0.03) = 23.48 mm

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Operation

Warning

Two peaks may appear when measuring pseudophakic eyes and with certain intraocular lenses. The first peak is a side maximum of the IOL, while the second peak is produced by the retina. In this case, manual correction is necessary (see page 100). It is expedient to measure at a number of different points.

Warning

Use the psph (pseudophakic) button to calculate secondary piggy-back IOLs. For this purpose, the ACD should be measured by a method other than the IOLMaster and the readings thus obtained entered into the appropriate boxes.

Measurement of corneal curvature [KER]

Measuring errors with pseudophakic eyes on

Keratometer measurement

Activate the KER measurement mode by:

• clicking on the

• pressing the <

• Tell the patient to focus on the yellow light!

• Align the device so that the 6 peripheral measuring points are symmetrical to the crosshair and appear optimally focused. The central point is usually not focused and is not evaluated for keratometer measurement! The IOLMaster with Advanced Technology indicates the optimum measurement setting by means of a green traffic light.

Note

Ensure that all six peripheral points are visible and located in the field between the two auxiliary circles on the display. It is recommended that the patient blink his/her eye shortly before the measurement to produce a continuous tear film. This will improve the reflectivity of the cornea. The measuring points should be circular or ellipsoid. If the measuring points are irregular (i. e. corneal scar) measurement is not possible. Precise measurements are possible only if the six peripheral measuring points appear optimally focused on the display.

KER icon or K> key SPACE BAR> in ALM mode [ALM]

Fig. 40 Setting for keratometer

measurement

• Trigger the measurement by pressing the knob on the joystick.

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Operation

Depending on the setting under Program settings/Program (see

35), a traffic light will assist in finding the optimum measurement

page setting. When the optimum measurement position has been reached, the traffic light will change from red to yellow to green. In Automatic mode (Automatic activated), three consecutive measurements will be triggered automatically once the knob on the joystick has been pressed and the optimum measurement setting (green traffic light) has been reached and remains constant for all three measurements. The automatic measurement procedure will be interrupted if the optimum measurement setting (green light) wavers and is resumed when the optimum setting is reinstated.

Five internal individual measurements are taken for a single keratometer measurement within 0.5 seconds. Following this, the radii or corneal K’s (depending on program settings) of the two principal meridians will be displayed, together with the respective axial orientation and the astigmatic difference. In the case of a spherical cornea, only the radius or a corneal K will be displayed, but no axial orientation or astigmatic difference. A blue progress bar in the status bar will indicate the progress of computation.

The size and shape of measurement points will be verified by the software. If a measurement point is not correctly identified, a blue flashing dot will appear. In the printout this will be marked by an x. These readings should not be used and a new measurement should be taken as a precaution. Keratometer measurements may be repeated as often as desired; however, only the last three measurements will be displayed.

Note

The IOLMaster requires three measurements to be taken! The message measure again will thus appear. Only then will a mean value be passed on to the IOL calculation and an evaluation enabled. Only the number of measurements is crucial here.

Note

In some cases (keratoconus, keratoglobus, corneal lesions, etc.) it may not be possible to reach the green traffic light for optimum measurement setting. In such cases the traffic light display can be briefly deactivated, enabling a measurement to be taken even when the light is on yellow or red. To do this, press the The Automatic display will disappear. However, now pay attention to the correct setting, as described above. Press the key once again to reactivate automatic. Automatic will always be switched back on for a new patient.

<M> key.

<M>

Fig. 41 Measurement point not

identified

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Fig. 42 Three keratometer readings

Operation

To delete one of the three displayed readings, highlight it and press

DEL> or <CTRL> + <Z>. Then confirm with YES.

If the last three readings differ by more than 0.5 D (mean value of the spherical equivalent of the last three measurements) or if the tolerance of the mean radius of the last three readings of 0.08 to 0.1 mm is exceeded (dependent on n), the Evaluation! message will appear on the screen.

• In this case, check the tear film of the eye being examined, ask the patient to blink if necessary and repeat the measurements until the results are within the tolerances. The Evaluation! message will then disappear.

• Potential measuring errors (inaccurate measurements) must be deleted as necessary, since the readings obtained in the Evaluation! state will not be accepted for ACD measurement, IOL calculation and the database for optimisation of constants.

Warning

To obtain consistent results we recommend checking the individual keratometer measurements and carrying out further measurements if necessary.

The following plausibility tests will be made with the keratometer reading:

R > 8.4 mm > Indicates possibility of a very flat corneal

curvature

R < 7.2 mm > Indicates possibility of a very steep corneal

curvature

|R1 - R2| > 0.5 mm > Indicates high astigmatism

When both eyes have been measured, the difference in the keratometer readings between the right and left eye will be checked. If this exceeds

0.2 mm or 1 D, you will be prompted to check the readings once again.

If this warning appears, be sure to verify that no pathological changes have occurred in the eye. It may be necessary to repeat the measurements. Only confirm the warning with the readings are plausible. Otherwise, determine what has caused the implausible readings. A reference to the displayed plausibility test message will be transferred to the comments box.

OK if you are certain that

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Operation

Measurement of anterior chamber depth [ACD]

Warning

The anterior chamber depth may only be measured on phakic eyes! ACD measurements of pseudophakic eyes result in measuring errors and/or incorrect readings. The readings for pseudophakic eyes do not reflect the anterior chamber depth.

Note

The keratometer measurement must be performed before anterior chamber depth measurement!

Activate the ACD mode by:

• clicking on the

• pressing the

The lateral slit illumination will automatically be turned on. This illumination subjectively appears to be very bright to patients. Nevertheless, the patient should continue to concentrate on the yellow fixation light.

• Fine adjust the device, so that: – the fixation point is displayed in optimum focus in the rectangle

on the screen (only the fixation point should be within the rectangle, not the other image details),

– reflections do not cause interference to the image of the cornea,

otherwise the reading will be incorrect,

– the anterior crystalline lens is optimally visible!

As a rule, the image of the fixation point will lie between the images of the cornea and the crystalline lens. It should be close to (but not within) the optical section of the crystalline lens! For system reasons, the corneal image will be out of focus.

ACD icon or

<D> key or

<SPACE BAR> in KER mode [KER].

Fig. 43 Setting for anterior chamber depth

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Operation

Note

The alignment of the device, particularly in the case of small pupils, requires a certain amount of practice on the part of the operator and cooperativeness on the part of the patient. The alignment procedure is easier on a dilated pupil (see also anterior chamber depth measurement, page

• Trigger the measurement by pressing the knob on the joystick.

Note

Before starting, tell the patient to look steadily at the fixation light

- not into the slit projector, as the latter will flicker during the measurement! When an acoustic signal is heard - the slit will again illuminate steadily - the measurement has been completed and the ACD values will be calculated.

Note: Anterior chamber depth on the IOLMaster is understood as the distance between the anterior vertex of the cornea and the anterior vertex of the eye lens. Hence, the displayed distance includes the thickness of the cornea. Calculation of the anterior chamber depth requires the input of the corneal radius. If a valid keratometer measurement was performed prior to ACD measurement, the system will automatically use the measured radius for the calculation. If the corneal curvature could not be measured with the IOLMaster, a window will appear requesting you to type in the radius (if the cornea is astigmatic, the values of both principal meridians).

118 ff.).

Tips for

• Enter a value between 4.0 and 13.0 (mm) (use decimal point). Continue with If you have selected the display Refractive index, please enter a number between 26 and 80 (D). When entering the refractive power, make sure that the same keratometer refractive index is set on the IOLMaster as on the keratometer used for the measurement (see

35).

page

Depending on the setting selected under Program settings/Program, a traffic light display is provided as an aid for optimum measurement setting (see page been reached, the traffic light will change from red to yellow to green. Arrows will show how the joystick must be moved in order to reach the optimum measurement position. In Automatic mode the measurement is triggered by pressing the knob on the joystick (Automatic activated), as soon as the optimum measurement adjustment (green traffic light) has been achieved.

Note

By clicking on the the program window for ACD measurement you can play a video showing the steps required to set the optimum measurement position.

OK or the <ENTER> key.

35). When the optimum measurement position has

VIDEO HELP button in the upper right corner of

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Operation

Note

In some cases it is possible that the green traffic light display for an optimum measurement setting cannot be reached. In such cases the traffic light display can be briefly deactivated, enabling a measurement to be taken even when the light is on yellow or red. To do this, press the disappear. However, now pay attention to the correct setting, as described above. Press the Automatic. Automatic will always be switched back on for a new patient.

Unfavourable room illumination will be indicated by a sun symbol. If necessary, the slit lamp is additionally switched on and off (flashing). This shows that additional dark exposures will be taken in order to expand the evaluation possibilities. Direct and lateral light incidence to the front of the device or eye being examined should be avoided. The best results will be obtained when the examination room is slightly darkened.

<M> key. The Automatic display will

<M> key once again to reactivate

Five internal individual measurements are taken for a single anterior chamber depth measurement within 0.5 seconds. Subsequently the anterior chamber depth will be determined for each individual measurement. A blue progress bar in the status bar will indicate the progress of computation. Five ACD readings will be listed in the display field next to the video image, together with the calculated mean value.

If the setting is not optimum, the images of the anterior lens and/or cornea cannot be evaluated. In this case the message "Measuring error" and a reference to the lack of or not correctly recognised image details is displayed. In addition the image of the first measuring error is displayed.

SHOW SEQUENCE all five images are displayed in succession. Upon

With examining the error cause, the calculated median value can be accepted despite warnings by pressing

OK.

The anterior chamber depth measurement may be repeated as often as desired.

If additional measurements are taken of anterior chamber depth, the previous readings will be overwritten. To restore the last (just overwritten) readings, press shortcut keys

<CTR> + <Z> (UNDO function).

Note

This UNDO function itself is irrevocable!

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Operation

Determination of "white-to-white" [WTW] (optional)

Activate the WTW mode by:

• clicking on the

• pressing the

• The patient should look at the yellow fixation point in the centre.

• Align the device so that the six peripheral light spots are symmetrical to the cross hairs and the iris structures or the edge of the pupil appears optimally focused. The fixation point in the centre of the six light dots is usually not in the centre of the pupil or iris, because only in the rarest cases does the visual axis correspond to the optical axis of the eye.

Warning

The patient should be asked if he or she sees the fixation point. If the patient fails to fixate properly, the visual axis will not be correctly recognised, which may result in measuring errors.

• Trigger the measurement by pressing the knob on the joystick.

WTW icon, or <W> key <SPACE BAR> in ACD mode [ACD].

Fig. 44 WTW determination

Each time the joystick knob is pressed, an image of the eye is displayed, in which the detected iris edge is marked. After checking that the iris and fixation point have been correctly recognised, confirm with Only then will the data be valid and available for further processing.

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OK.

Operation

Warning

The validity of the WTW determination depends on this check of correct recognition of the iris edge. The WTW value is the horizontal diameter of the iris. In addition to the WTW value, the deviation of the visual axis from the centre of the iris (x, y) will also be displayed (

The values are stated in millimetres with reference to a Cartesian coordinate system, the zero point of which is assumed to be in the established centre of the iris or pupil. If the visual axis is above the iris or pupil centre, the Y value will be positive; if it is below, the value will be negative. X values to the left of the centre are negative; those to the right are positive.

Note

If the software has difficulty detecting the iris or fixation point, this may be due to inadequate room lighting. It is recommended that the front panel and examined eye be shielded from direct or lateral light. The best results will be obtained when the examination room is slightly darkened.

Fig. 44).

WTW measurement may be repeated as often as desired.

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Operation

Measuring the other eye

The system automatically registers which eye is being measured (OD or OS). All past readings of this patient are still stored and may be retrieved as necessary.

Measurements of the other eye must be performed analogously to the previous eye.

Note

After each change of side, the overview mode [OVW] is automatically activated for coarse alignment.

Printout of results

Once the measurements have been completed, the readings, composite signal and a diagram of iris, pupil and WTW can be printed out.

Caution

Consult the user manual supplied with the printer. Connect the printer as described in Setting up the device for use on page 21.

Note

The following print formats are supported (upright format only): A4 (210 x 297 mm), Letter (8.5" x 11.0"), B5 (182 x 257 mm).

The printout of the readings may be started from every measurement mode (ALM, KER, ACD, WTW). The printout will include all results obtained so far (also those of the other eye, if already available). It is advisable to start the printout only if all results of both eyes are available.

Note

Do not take any further measurements during the printing process.

Press the

PRINT icon or <P> key to start the printing process.

Note

In ALM mode the printout of the graph with the blue highlighted reading can be enlarged by pressing the display of the graph see page 101. In WTW mode the current reading can be printed out using

<CTRL> + <P>.

<CTRL> + <P>. For enlarging

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Operation

Generation of IOL options

Once all measurements have been taken (depending on the IOL calculation formula), options can be generated for intraocular lenses to be implanted.

Filling the IOL database

Before the system can calculate IOL options, the available lens types must be entered into the database.

•InOptions - Lens database open the Please enter password dialog box.

• Select the appropriate name and enter password as necessary. The database window for entering the specific lens data will open (for registering a new user see page

29).

Fig. 45 Please enter password

dialog box

Fig. 46 Database window for the input of lens data

• In the lines Name, A Const. Manufacturer and ACD Manu- facturer enter the respective data for the manufacturer, from catalogues or package inserts.

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Warning

If the ACD constant is not available, you may click the entering the A constant. All parameters will automatically be calculated from the A constant according to standard formulae. However, the manufacturer’s A constants are not optimal for optic biometry and may result in refractive deviations.

• Your IOL constants which have been optimised for various calculation formulae for optical biometry or your personally determined

constants must be entered/changed in the A Const. SRK

A Const. SRK

/T, a0, a1, a2, pACD and SF boxes.

Note

Only constants optimised for optical biometry should be used for calculating the suggested strength of the intraocular lens to be implanted with the IOL Master, not the manufacturer’s IOL constants (see also pages

84 and 107).

• If you use lenses graded in 0.25 D intervals (in future), activate the Power steps 1/4 D radio button.

• To add data to the database, click the

ADD button.

• To delete the data of the lens type selected in the Lens field, click the

ERASE button.

• By clicking the

SET button, existing lens data will be overwritten by

edited data.

• To enter the data of the next lens, overwrite the name of the lens. Exit the Lens database by clicking on

OK.

ADD button after

II,

IOL calculation

Start the calculation by:

• clicking on

The IOL calculation window appears in which the measured values of both eyes are automatically entered. Depending on the choice of corneal K’s/radii in the Program settings submenu (page 35), the keratometer readings are displayed in either Corneal K values (D) or Radii (mm).

IOL or pressing the <I> button.

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Fig. 47 IOL calculation window SRK®/T

• Click on the appropriate tab to select the desired formula. The Haigis, HofferQ, Holladay, SRK

II, and SRK®/T formulae are

implemented as standards.

• After refractive corneal surgery the Haigis-L or Prior refractive surgery tabs may be selected.

• Selected phakic implants may be calculated with the Phakic IOL tab.

• Select the eye surgeon’s name. This gives the surgeon access to lens types saved to his database.

• The measured values may be edited if desired.

Warning

Edited readings appear with an asterisk (*) in the printout of the lens calculation and the lens calculation is no longer based on the IOLMaster readings!

• Select an eye for which the IOL is to be calculated on the screen.

• Enter the desired target refraction. No entry means 0 D (plano).

• Select suitable lenses from the lens types shown.

• After you have entered the necessary data, click on the

IOL CALCULATION button. This will start IOL calculation of each lens

type selected. The calculation will be performed for every measured eye. However, only the data of the selected eye is displayed on the screen.

• To change the display, select the other eye under Surgical Eye. The lenses calculated for the other eye will now be displayed.

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Fig. 48 Calculated IOL data in IOL calculation window SRK®/T

In the columns below each specified lens you will find the calculated refractive powers and target refractions for those lenses. The middle line appearing in bold type indicates which refraction of the corresponding IOL comes closest to the desired target refraction.

Warning

The IOL calculation is valid only if the biometric measurement was correct, an appropriate IOL calculation formula was selected and the IOL constants were optimised for the specific application.

The data calculated for the IOL to be implanted can be printed out.

• For this purpose, click on the The IOL data of both eyes or of one eye and emmetropic IOL will be printed out either on a single page or on separate pages, depending on the option selected in the Program settings menu (page

• Click on

OK to finish IOL calculation.

PRINT button.

34).

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IOL calculation after corneal refractive surgery (optional)

Corneal refraction is an important quantitative factor in IOL calculation. Presently, it is impossible to exactly measure the corneal refraction that was subjected to corneal refractive surgery (e.g. by RK, PRK, LTK, Lasik or Lasek). For this reason, a different method of determining corneal refraction must be adopted for the IOL calculation. Three methods are available:

 Refractive history method

 Contact lens method

 Haigis L method, should the preLasik or corresponding contact lens

values not be available.

Prior to calculating an option for an intraocular lens, the corneal refraction must be determined.

Start the calculation by:

• clicking on

• selecting Prior Refractive Surgery tab.

Warning

This step is necessary only with corneas pretreated by refractive surgery. With untreated corneas, IOL calculation starts instantly upon selection of the biometric formula (see

Refractive history method

The following values must be known for the refractive history method:

 Preoperative corneal refraction (i.e. before corneal refractive surgery)

 Preoperative refraction

 Stable postoperative refraction

 Corneal vertex distance.

As the change in refraction was achieved by variation of the corneal refraction, the currently effective corneal refraction directly results from the difference between preoperative and postoperative refraction, corrected by the corneal vertex distance (vertex correction). The computational method is described in the technical literature. If the corresponding data of the patient is available, the refractive history method delivers the most accurate results.

IOL or pressing the <I> button.

IOL calculation on page 76).

For the calculation of the IOL, the corneal K’s selected by the examiner with

APPLY will be transferred to the IOL calculation table. The IOL

calculation can be started after selection of the biometric formula.

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Contact lens method

The contact lens method (contact lens overrefraction) attempts to determine the currently effective corneal refraction on the basis of two refraction measurements, once with and once without a hard "plane" contact lens.

The following parameters are needed:

 refraction with contact lens,

 refraction without contact lens,

 refractive power of the (plane or almost plane) hard contact lens -

refractive power of contact lens back surface and

 corneal vertex distance.

In the ideal case, the refractive power of the contact lens back surface is equal to the unknown corneal refraction. For this purpose, several hard plane contact lenses with refractions of the back surface between 30 and 45 D should be available. For the calculation of the corneal refraction, enter the appropriate patient data into the display mask. The values will now be calculated.

Fig. 49 IOL calculation window Prior Refractive Surgery

For the calculation of the IOL, the corneal K’s selected by the examiner

APPLY will be transferred to the IOL calculation table. The IOL

with calculation can be started after selection of the biometric formula.

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Warning

The calculated refractive power/radii values may not be edited in the IOL calculation window for the selected formula!

The corneal K’s transferred to the IOL calculation are marked in the printout of the lens calculation with (**) and the calculation method.

Haigis L method

In contrast to the above-described methods of determining corneal refraction, the Haigis formula allows for surgical changes to the cornea and permits the calculation of the IOL from the measured values AL, Corneal K’s and ACD.

The Haigis-L formula offers two alternatives for IOL calculation. The correct choice of alternative is important, otherwise the calculation will be incorrect.

If you wish to perform the calculations for eyes that were previously treated by myopic LASIK, myopic PRK or myopic LASEK, press the button prior to calculation.

Warning

The formula may only be used for eyes with myopic LASIK, myopic PRK and myopic LASEK. Lenses by hyperopic LASIK/LASEK/PRK or myopic/hyperopic RK should never be calculated. The corneal radii and axial lengths measured by the IOLMaster are required for the formula. The measured values cannot be edited here.

MYOP

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Fig. 50 IOL calculation window Haigis-L

If you wish to perform the calculations for eyes that were previously treated by hyperopic LASIK, hyperopic PRK or hyperopic LASEK, press

HYPEROP button prior to calculation.

the

Warning

The formula may only be used for eyes with hyperopic LASIK, hyperopic PRK and hyperopic LASEK. Lenses by myopic LASIK/LASEK/PRK or myopic/hyperopic RK should never be calculated. The corneal radii and axial lengths measured by the IOLMaster are required for the formula. The measured values cannot be edited here.

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Calculation of phakic implants (optional)

This program component enables the thickness of phakic implants (iridocorneal anterior and posterior chamber angle-supported lenses) to be calculated.

Only spherical lenses can be calculated. In addition to the anterior chamber depth and corneal radii (corneal refraction) measured with the IOLMaster, the refraction for the appropriate corneal vertex (CVD) and lens model must be entered.

The manufacturer’s IOL constants are used for calculating lens power.

Warning

Please observe the manufacturer’s recommendations for the phakic IOL employed with regard to choice of lens type and critical distance to the endothelium.

Fig. 51 Lens model

Fig. 52 Calculation of phakic implants

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4-in-1 calculation

To compare the results of four different calculation formulae, select one of the four selection boxes for the desired formula.

Select the results, press

IOL CALCULATION to display the results. To print out the page with

PRINT.

Optimisation of lens constants

Selecting lens data

The lens data available in the database may be optimised by the following procedure.

• In the Options menu, open Lens database. Select the respective eye surgeon and confirm your choice with

• Choose a lens. The input mask contains constants calculated from "A Constant Manufacturer" or previously optimised constants.

• Click on the

OPTIMIZE button. The dialog box for the selected lens

will appear and the lens constants can be seen in the (Fig. 53).

OK (Fig. 54).

BASIS column

Fig. 53 Lens data in dialog box for

selected lens

Fig. 54 Lens data in the Lens Database dialog box

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Loading existing data records

• Click on the LOAD button to load the data records of all patients available for optimisation.

Fig. 55 Assign data records dialog box

Special filter functions allow fast selection of patient data. The right column shows the list of all patients available for optimisation.

• Click on the desired patient data record in this list to select it.

• Select the eye to be used for the optimisation calculation. The fields below show the measurement data of the IOLMaster.

• If you wish the data of the other eye to be kept in the data table for further optimisation, activate keep other side in table in the check box.

• Click on the << button to load the selected data record in the left- hand table. These data records are intended for IOL optimisation.

• Transfer at least eleven data records into the left-hand table in this way.

• Click on the >> button to return the selected data record to the right-hand table if it is not to be used for optimisation, but should be kept for possible later use.

• Click on the the right or left.

• When all the desired data records have been loaded into the lefthand table, press

• Further patient records can be added to the left-hand list for subsequent additional optimisations.

ERASE button to irrevocably delete the data record to

OK to return to the optimisation box (Fig. 54).

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Note

The data contained in the database (right- and left-hand table) will not be deleted automatically and are thus available for later additional optimisations. A backup should be made at regular intervals by transferring data to an office management system or a printout.

Entering new data records

• To enter data records which do not exist on the IOLMaster result table, click on the

This will bring up an input mask for creating a new data record to be optimised. However, this data record may be used for optimisation only, not for IOL calculation. Nor does it appear in the patient database.

NEW button.

Fig. 56 Input new data record dialog box

Warning

Only data obtained from the IOLMaster may be entered in the fields for pre-operative data! When entering the refractive power, make sure that the same keratometer refractive index is set on the IOLMaster as on the keratometer used for the measurement (see page

The entry of data measured on ultrasound devices will yield incorrect results!

Warning

The data records of patients who have undergone refractive surgery of the cornea should be excluded from optimisation.

• Complete the entries in the input mask.

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Note

The entry of the Exam Date is mandatory! Entry of Opt. ACD data, Surgery Date and Post Op Date is optional.

Note

There should be a period of at least 8 weeks between the surgery and post-op dates. (This period, however, will not be checked!)

• If you wish to reject the entries made and return to the optimisation calculation, click on the

• To confirm the new data record and add it to the list of data records

to be used for optimisation, click on the record is shown in the Data records field. It is displayed in the list of data records.

Entering post-operative data

• Highlight the patient data record by clicking on it.

• In the Impl. IOL (D) box, enter the power of the implanted IOL.

• In the Post Op Ref. box, type in the post-operative refraction.

• The entry of Surgery Date and Post Op Date is optional. When entered, however, the data will be checked for plausibility.

CANCEL button.

OK button. The new data

Note

There should be a period of at least 8 weeks between the surgery and post-op dates. (This period, however, will not be checked!)

Fig. 57 Assign data records dialog box

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• Complete all selected patient data records in this way. The number of data records containing IOL and post-op ref data and the total number of loaded data records is specified in the Data records box.

The boxes beneath it show the number of data records in the specified axial length ranges.

Once all IOL and post-op data has been entered, the requirements for the optimisation calculation have been met.

 If a patient data record is highlighted in red, no IOL and/or post-op

ref data has been entered for this data record or a measured value (AL or KER) is missing!

 If a data record is highlighted in yellow, no ACD values exist as yet:

a0 (Haigis formula) will not be optimised with such data records!

 Patient data records appearing on a white background contain all

the data required for optimisation.

Note

Only the a0 can be optimised with the device software for the Haigis formula. For the optimisation of a0, a1 and a2 (more than 200 data records required) please send this clinical data to Carl Zeiss Meditec.

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Starting optimisation

• Start the optimisation calculation by clicking on the OPTIMIZE button. Depending on the number of data records to be processed, the computing process may take some seconds.

The optimised lens constants will now be displayed in the New column.

Note

Data records with an IOL power of 0 D will not be included in the optimisation process.

The optimisation calculation supplies lens constants for every patient’s data record as they should have been on the basis of the measured values and results of surgery. The mean value (sum of all lens constants divided by the number of patients) and standard deviation are then calculated. Lens constants which are more than double the standard deviation are not included in the optimisation.

Fig. 58 Optimised lens constants

If less than 11 data records exist for optimisation or data records are rejected (0 D), "---" will appear in the New column. In this case the optimisation has failed.

Repeat the optimisation process, in this case with a larger number of data records, or perform several optimisations for various groups of eyes (e.g. short, normal and long eyes). This procedure also ensures a higher degree of accuracy in IOL calculation.

The resulting mean value will be displayed as an optimised constant. To obtain optimum constants, patients with pre-, inter- or postoperative complications which could affect the refraction state should be excluded.

Note

The displayed a0 value does not take into account the data records highlighted in yellow!

• To reject the last optimisation run, click on optimised constants will not be saved to the lens data base, even if a new data record has been entered.

• Confirm the newly optimised lens constants by clicking on the button to the right of the Basis field. In this case, all optimised constants will be accepted. If you want to accept a special constant only (e. g. a0), click on the

<< button right of this constant.

CANCEL. In this case, the

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Fig. 59 New data record has been added

• Click on constants will only be saved to the lens database and for use in future IOL determination if they are confirmed with

• Click on

OK to return to the Lens Database. Optimised lens

OK.

OK to return to the IOLMaster main module.

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New patient

If you have completed measurements on one patient and wish to continue with another patient, click on

– the – the

The readings of the previous patient to the left and/or right will be stored and removed from the display. The patient manager appears and new patients can be entered or be imported from via the DICOM or EMR interface from the waiting room (optional).

After importing the new patient data and selecting a patient, or manually entering the new patient data, switch to Overview mode [OVM] by clicking

PATIENT MANAGER icon or <N> button.

Note

Data is available in the internal database for the period preset in under Program settings/Program (see page 34).

<ENTER> or NEW.

Note

The above order of measurements is only an example. You may also run the above-described measurements in a different order. The only requirement is that the keratometer measurement precedes the anterior chamber depth measurement.

Working with the Patient manager

The IOLMaster keeps an internal patient file. All data is stored here and can be retrieved (viewing, post-treatment, printing).

Note

The file is not designed for archiving patient and measurement data.

The database field is structured similar to Windows Explorer (see left side). A + sign at the branch indicates that the database already contains measurement results for this patient.

Fig. 33,

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The "person on index card" symbol in front of the patient signifies that this patient has only been registered locally on this PC. The "person on network" symbol means that this patient has been imported from a hospital information system. The person is shown in blue if measurements are already available. The colour is grey if no measurements exist yet (see also section on page 53). Measurements are indicated by a clock. Measurements already transferred to the hospital information system are additionally indicated by a red arrow.

• Click on + to display the treatment data for the last measurement(s). To close, click on the - sign.

The data records are sorted alphabetically by last name.

Use the Search textbox to quickly access a data record. Place the cursor in this box and type in the desired last name to list all relevant data records. The following letters of the name can also be entered; this ensures fast access to the desired data record.

Patient Manager (New patient)

On repeat visits, data can be instantly transferred to the input area by clicking on the patient’s name.

To take a new measurement, click the shortcut

<ALT> + < N>.

NEW button or use the keyboard

Retrieving a reading from previous measurements

The system permits the review of data records of previous sessions.

• Click on the + sign in front of the patient’s name.

• Use the cursor to mark the examination date being sought.

• To view the measured data, press the shortcut

<ALT> + <F> or double-click on it. The data record is now

ready for further editing. However, no new measurements can be taken.

• Automatic right/left detection is deactivated. To select a side, click the cursor on the appropriate display or press the

OPEN icon, use the keyboard

<R> or <L> key.

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Deleting a patient/measurement

• To delete a patient from the patient list, highlight the name and press

<DEL> or select Erase from the Patient menu.

• Confirm the delete action with YES.

Personal data and individual measurements for this patient will be irrevocably deleted in the Patient Manager. The numerical measurement data will still be available in the database for optimisation of lens constants.

Note

If you are working with the option Operator login with password, you may only delete patient data if you have the

appropriate rights (see

If a measurement date is highlighted, only the data for this examination date will be deleted. The patient name and other measurement data will be retained.

User Manager on page 40).

Note

In Options - Setup - Program settings you can set the number of days after which a data record is automatically deleted (5 to 365 days).

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Renaming a patient

To edit the last name, first name, date of birth or ID Number of a patient, follow this procedure:

• Highlight the patient’s name and press Rename in the Patient menu.

The patient data can be edited in the dialog box which now appears.

Once the renaming has been confirmed, patient data for all measurements will be changed. Measurement results cannot be renamed!

• Confirm the changes with

RENAME.

<CTRL> + <R> or select

Fig. 60 Rename record dialog box

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Zeiss IOLMaster User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual