Topcon ALADDIN User Manual

ALADDIN - User manual Rev. 23 of 08/07/2016

ALADDIN

User manual

0123

Product cod. 1240211 ALADDIN HW2.0 Rev. 23 - 2016

ALADDIN - User manual Rev. 23 of 08/07/2016

Caution: Federal law restricts this device to sale by or on the order of an optometrist, optician, or an

ophthalmologist.

Thank you for choosing this product.

Please read the information in this manual carefully. You must be familiar with its contents in order to work with the device.

The manufacturer has a policy of continuous improvement of its products, so it is possible that some instructions, specifications and pictures in this manual may differ slightly from the product you purchased. The manufacturer also reserves the right to make any changes to this manual without notice.

The original text of this manual is in English.

SW v.: 1.5.x

Manufacturer

VISIA imaging S.r.l. Via Martiri della Libertà 95/e 52027 San Giovanni Valdarno (AR) Italy

Distributor

Topcon Europe Medical B.V. Essebaan 11 2908 LJ Capelle a/d IJssel The Netherlands www.topcon.eu medical@topcon.eu

ALADDIN - User manual Rev. 23 of 08/07/2016

Contents

1 Intended Use ............................................................................................................................................. 7

1.1 Description of functionalities ............................................................................................................ 7

1.2 Users .................................................................................................................................................. 9

1.3 Positioning the patient .................................................................................................................... 10

1.4 Places of use .................................................................................................................................... 10

1.5 Contraindications ............................................................................................................................ 10

2 Accessibility and scope of the manual .................................................................................................... 11

3 Introduction ............................................................................................................................................ 12

3.1 Main characteristics ........................................................................................................................ 12

4 Precautions ............................................................................................................................................. 13

4.1 EMC table ........................................................................................................................................ 14

5 Symbols ................................................................................................................................................... 16

5.1 Labeling on the device ..................................................................................................................... 17

6 Safety instructions .................................................................................................................................. 18

6.1 General ............................................................................................................................................ 18

6.2 Electrical safety ................................................................................................................................ 19

6.3 LED emission safety ......................................................................................................................... 19

6.4 Installation with external devices or IT Network............................................................................. 19

6.5 Transport and packaging ................................................................................................................. 20

6.6 Cleaning ........................................................................................................................................... 20

6.7 Package contents ............................................................................................................................. 20

6.8 Checking the measurements ........................................................................................................... 20

6.9 Cybersecurity ................................................................................................................................... 21

7 Product warranty and reliability ............................................................................................................. 22

8 Legal provisions ...................................................................................................................................... 22

9 Components ............................................................................................................................................ 23

9.1 Main Body ........................................................................................................................................ 23

9.2 Other components .......................................................................................................................... 24

10 Installation /uninstallation of the system ............................................................................................... 25

10.1 Installing the system ........................................................................................................................ 25

10.2 Uninstalling the system ................................................................................................................... 28

11 ALADDIN accessories and equipment ..................................................................................................... 31

11.1 Standard equipment ........................................................................................................................ 31

ALADDIN - User manual Rev. 23 of 08/07/2016

12 Setting up the instrument ....................................................................................................................... 32

12.1 Connection modes ........................................................................................................................... 32

13 OPERATING INSTRUCTIONS .................................................................................................................... 33

13.1 General description of functionalities ............................................................................................. 33

13.1.1 General instructions ................................................................................................................ 34

13.2 Checking the calibration .................................................................................................................. 34

13.3 Patient entry/selection .................................................................................................................... 38

13.3.1 Creating a new patient ............................................................................................................ 39

Entering special characters ................................................................................................................ 39

Selecting crystalline and vitreous body type ...................................................................................... 39

13.3.2 Selecting or modifying a patient .............................................................................................. 43

Open an examination or acquire data for the selected patient ......................................................... 43

Delete or edit the selected patient .................................................................................................... 43

Insert the Post-Op (after surgery) refraction data ............................................................................. 44

13.3.3 Selecting a patient from Server ............................................................................................... 45

Start an exam from the Waiting Room .............................................................................................. 47

13.4 Acquisition environment: general instructions ............................................................................... 48

13.4.1 Description of the Acquisition screen...................................................................................... 50

Description of results ......................................................................................................................... 50

Errors in Measurements ..................................................................................................................... 51

Biometry ............................................................................................................................................. 52

Pupillometry ....................................................................................................................................... 53

13.5 Full biometry acquisition (K-AL-ACD) .............................................................................................. 53

13.5.1 Acquisition procedure ............................................................................................................. 54

13.5.2 Further adjustments for the anterior chamber depth ............................................................ 56

13.6 Acquisition of axial length measurements (AL) ............................................................................... 56

13.7 Acquisition of the anterior chamber measurement (ACD) ............................................................. 57

13.8 Keratometry acquisition (KER) ......................................................................................................... 59

13.9 Acquisition of the dynamic, photopic, mesopic pupillometry........................................................ 61

13.10 Report printing ............................................................................................................................ 63

13.10.1 Available Printers ................................................................................................................. 64

13.10.2 Custom Reports ................................................................................................................... 65

13.11 Data Exportation .......................................................................................................................... 66

13.12 IOL CALCULATION ........................................................................................................................ 68

13.12.1 Data ..................................................................................................................................... 69

13.12.2 Spherical IOL calculation ...................................................................................................... 71

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13.12.3 Toric IOL calculation ............................................................................................................ 73

13.12.4 Post Refractive IOL calculation ............................................................................................ 76

13.13 MEASUREMENTS ......................................................................................................................... 79

13.13.1 TOPOGRAPHIC MAP (KER) ................................................................................................... 79

Topographic map indices ............................................................................................................... 80

Keratometry ................................................................................................................................... 80

Keratorefractive indices ................................................................................................................. 80

Keratoconus ................................................................................................................................... 81

Pupil ............................................................................................................................................... 82

Profile ............................................................................................................................................. 84

13.13.2 Zernike ................................................................................................................................. 85

13.13.3 AXIAL LENGTH (AL) .............................................................................................................. 88

13.13.4 ANTERIOR CHAMBER DEPTH (ACD) ..................................................................................... 89

13.13.5 PUPILLOMETRY (PUP) .......................................................................................................... 89

Display............................................................................................................................................ 90

Sequences ...................................................................................................................................... 90

Dynamic ......................................................................................................................................... 90

Photopic, Mesopic ......................................................................................................................... 91

Functions........................................................................................................................................ 91

Graphs ............................................................................................................................................ 91

13.13.6 WHITE TO WHITE ................................................................................................................. 94

13.14 EXAMINATION DATA SAVING ...................................................................................................... 97

13.15 SETTINGS...................................................................................................................................... 98

13.15.1 General ................................................................................................................................ 99

13.15.2 Measurements ..................................................................................................................... 99

Scales ............................................................................................................................................. 99

Topography Map Color scale ....................................................................................................... 102

Map Option .................................................................................................................................. 103

Pupillometry ................................................................................................................................ 103

13.15.3 Surgeons ............................................................................................................................ 104

13.15.4 IOL ...................................................................................................................................... 105

General ........................................................................................................................................ 105

Preset ........................................................................................................................................... 106

IOL list .......................................................................................................................................... 108

13.15.5 Connectivity ....................................................................................................................... 115

Network folder configuration ...................................................................................................... 115

XML Export ................................................................................................................................... 116

IMAGEnet i-base software ........................................................................................................... 116

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IMAGEnet 6 Server software ....................................................................................................... 117

Export to External Software settings ........................................................................................... 117

DICOM .......................................................................................................................................... 119

13.15.6 Admin ................................................................................................................................ 121

Report .......................................................................................................................................... 121

Remote Assistance ....................................................................................................................... 122

Updating the integrated software ............................................................................................... 123

Backup & Restore ........................................................................................................................ 128

Closing the software .................................................................................................................... 132

14 Operating voltage and fuse change ...................................................................................................... 133

14.1 Changing the operating voltage .................................................................................................... 133

14.2 Changing the fuse .......................................................................................................................... 134

15 Technical specifications ........................................................................................................................ 135

15.1 General .......................................................................................................................................... 135

15.2 Electrical data ................................................................................................................................ 135

15.3 Optical radiation ............................................................................................................................ 136

15.4 Performance Testing ..................................................................................................................... 137

15.5 Information on measurements ..................................................................................................... 139

15.6 Environmental conditions ............................................................................................................. 139

15.7 Mechanical Specifications ............................................................................................................. 140

15.8 Other Specifications: Onboard PC component specifications ....................................................... 140

16 Declaration of conformity ..................................................................................................................... 141

17 Appendix: Installing an external printer .............................................................................................. 142

17.1 Getting drivers and transferring them to ALADDIN ...................................................................... 142

17.2 Disabling the Write Filter ............................................................................................................... 142

17.3 Installing a local printer (USB) ....................................................................................................... 143

17.4 Installing a network printer (LAN) ................................................................................................. 146

17.5 Re-Enabling the Write Filter .......................................................................................................... 147

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1 Intended Use

ALADDIN is intended for biometric determination of the following ocular measurements: axial length, corneal radius, corneal cylinder axis, anterior chamber depth, white-to-white (WTW) and pupil diameter of the human eye. ALADDIN also measures corneal topography.

For patients who are candidates for intraocular lens (IOL) implantation, ALADDIN also aids in the calculation of the appropriate IOL power and type to be implanted.

ALADDIN is intended for use by physicians and eye-care professionals and may only be used under the supervision of a physician.

1.1 Description of functionalities

Aladdin is a combined device for the measurement of various parameters used in the application of intraocular lenses.

The instrument can work in two different modes:

1. Consecutive acquisition of all the measurements available on the eye

2. Individual acquisitions for each type of measurement

Aladdin includes six types of measurement in a single instrument.

 Axial length(AL)  Corneal topography  Keratometry(KER)  Corneal diameter (white-to-white)  Pupillometry  Anterior chamber depth (ACD)

Axial length is the distance between the cornea and the inner limiting membrane. It is measured with a lowcoherence interferometry system with a super luminescent diode. The measuring range goes from 15 mm to 38 mm

Keratometry is used to measure the corneal curvature. It is based on the reflection of the Placido disk on the eye at a controlled working distance for high measuring precision.

Aladdin allows the user to acquire the corneal topography of the eye. The “Corneal Map” is obtained from the reflection of 24 rings of the Placido disk at a distance of 80 millimetres from the patient's eye. The position

of the device in relation to the patient’s eye serves as the starting point to make adjustments in the respective

measurement modes. With the acquisition of the corneal topography, the Corneal Diameter can be determined. The Corneal Diameter is also known as "white- to- white" distance.

The pupillometry is performed with LEDs of different wavelengths. In particular, the instrument uses infrared LEDs to dilate the pupil and white LEDs to reproduce photopic light conditions and to contract the pupil (dynamic pupillometry).

ACD (anterior chamber depth) is the distance between the anterior surface of the crystalline (anterior capsule) and the outermost stratum of the cornea (epithelium), measured along the optical axis where the latter is biggest. This measurement is performed using the reflection principle of a slit light projected onto the anterior surfaces of the eye.

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Caution should be practised when using the device’s ACD measurement for any given intraocular lens

calculation because of the high variability of this measurement.

The ACD measurement is the distance between corneal epithelium and the crystalline lens surface.

Aladdin has an onboard PC with the dedicated software that provides all the functionalities described.

The information obtained from the measurements can be used for various applications, for example: Cataract operations, IOL calculation, IOL toric calculation and post lasik calculation. The intraocular lens power suggestion is made using scientifically recognised formulae: Holladay 1, Haigis, Hoffer Q, SRK / T, SRK II, Camellin-Calossi, Shammas No history.

The Haigis, HofferQ, Holladay, SRK® II and SRK®/T formulae are implemented in the software. Please refer to the following literature references on the formulae (in case of specific questions please contact Visia Imaging):

• 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

• Reply: Errata in printed Hoffer Q formula. Journal of Cataract & Refractive Surgery, Volume 33,

Issue 1, Pages 2-3, January 2007, Authors:Kenneth J. Hoffer, MD

• 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

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

Relations between ultrasound and optical biometer calculation constants:

• RETZLAFF J, SANDERS DR, KRAFF MC (1990): Lens Implant Power Calculation - A manual for

ophthalmologists & biometrists, 3rd edition, Slack Inc, Thorofare NJ, USA

• HAIGIS W, LEGE B, MILLER N, SCHNEIDER B: Comparison of immersion ultrasound biometry and

partial coherence interferometry for IOL calculation according to Haigis, Graefes Arch Clin Exp Ophthalmology (2000) 238:765-773

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• HOLLADAY, JT: International intraocular lens implant registry 2003. J Cataract Refract Surg (2003)

29:176-197

• HAIGIS W: Relations between optimized IOL constants. Symposium on Cataract, IOL and

Refractive Surgery of the American Society of Cataract and Refractive Surgery (ASCRS), Philadelphia, PA, USA, June 1-5, 2002, Abstracts, p.112, 2002

Intraocular lens power calculation AFTER corneal refractive surgery:

• Camellin-Calossi: M. Camellin, MD; A. Calossi, Optom “A new formula for intraocular lens power

calculation after refractive Corneal Surgery”, Journal of Refractive Surgery, vol. 22 Feb. 2006.

This formula is for use in patients who have had prior refractive surgery. Each such patient is

unique and results may vary widely. You should interpret all IOL power recommendations with caution.

• Shammas No-history: SHAMMAS H.J., SHAMMAS M.C: “No-history method of intraocular lens

power calculation for cataract surgery after myopic laser in situ keratomileusis”, J Cataract Refract Surg 2007; 33:31–36 Q 2007 ASCRS and ESCRS.

• Shammas No-history: SHAMMAS H.J., SHAMMAS M.C., GARABET A., KIM J.H., SHAMMAS A. ,

LABREE L.: Correcting the Corneal Power Measurements for Intraocular Lens Power Calculations After Myopic Laser In Situ Keratomileusis” - American Journal of Ophthalmology (Impact Factor:

4.02). 10/2003; 136(3):426-32.

• Shammas No-history: SHAMMAS H.J., SHAMMAS M.C., HILL W.E.: Intraocular lens power

calculation in eyes with previous hyperopic laser in situ keratomileusis” - J Cataract Refract Surg 2013; 39:739–744 Q 2013 ASCRS and ESCRS.

Toric IOL calculation:

 HB Fam, KL Lim: Meridional analysis for calculating the expected spherocylindrical refraction in

eyes with toric intraocular lenses. Journal of Cataract & Refractive Surgery, 2007 - Elsevier

 N Alpins: Astigmatism analysis by the Alpins method. Journal of Cataract & Refractive Surgery,

2001 - Elsevier

 G Savini, KJ Hoffer, M Carbonelli, P Ducoli: Influence of axial length and corneal power on

the astigmatic power of toric intraocular lenses - Journal of Cataract & …, 2013 - Elsevier

 JT Holladay, TV Cravy, DD Koch: Calculating the surgically induced refractive change following

ocular surgery. - Journal of Cataract & Refractive Surgery, 1992 – Elsevier

 Abulafia A, Koch DD, Wang L, Hill WE, Assia EI, Franchina M, Barrett GD: New regression formula

for toric intraocular lens calculation. – Journal of Cataract & Refractive Surgery, 2016 - Elsevier

1.2 Users

Users: medical staff, opticians, ophthalmologists.

For surgery and intraocular lens implantation, the device can only be used under medical supervision. For the other applications, the device must be used by qualified personnel.

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1.3 Positioning the patient

The patient must be positioned in such a way that the distance from the device to the eye is 80 mm. A steady head position and the correct device-to -patient distance is promoted by resting the patient’s head well against the chin rest and forehead band.

A correct alignment with the patient’s pupils can be visually checked by the operator referring to the two

lines on the forehead supports.

Figure 1

It is necessary to tell the patient to look steadily at the fixation point in the center of the Placido disk.

The position of the device in relation to the patient’s eye thus found is a starting point for fine measurement

adjustments. The patient does not use the controls. The patient may be an elderly person, an invalid, or a child. In any case the device is to be controlled by the aforementioned specialized personnel.

1.4 Places of use

The intended places of use are: health care centers, doctors' surgeries, operating theatres.

1.5 Contraindications

Patient could have a dazzle effect, after the exam, dues to the device lights, but it disappears in few minutes.

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2 Accessibility and scope of the manual

Keep these instructions in a safe place close to the device. The manual must be at hand at all times. For best use of the instrument, read the instructions carefully.

The purpose of this manual is to inform the user as to all the device's functions, settings, safety, installation, maintenance, cleaning and storage instructions.

ALADDIN - User manual Rev. 23 of 08/07/2016

3 Introduction

3.1 Main characteristics

ALADDIN is a multifunction medical device used for the detection of various biometric parameters, particularly useful for the calculation of spherical, toric or personalized intraocular lenses. It records a wide range of parameters, which are acquired by using different techniques.

Optical Biometry: by means of the low-coherence optical interferometry method, ALADDIN executes axial length measurements (between 15 and 38mm).

Anterior chamber depth: slit light projection - by projecting a slit of certain characteristics onto the eye, you can determine the length of the optical axis of the anterior chamber, a very important measurement for the calculation of IOL.

Topography: the device acquires a topographic map of the patient of approximately 6,200 points using a 24ring Placido disk to show the description of the corneal surface. This measurement also provides a Keratometry at 3mm, 5mm and 7mm 7mm (or at 2,4,6 mm depending on the settings) with the respective corneal astigmatism.

Pupillometry: for an accurate calculation of intraocular lenses, the instrument has a set of LEDs onboard that allows a measurement of Photopic, Mesopic and Dynamic pupillometry.

White-to-White: as a result of the corneal topography and by means of an internal software algorithm, a white-to-white value can be obtained, i.e. the corneal diameter recorded at the limbus.

The software can give suggestions for the choice of intraocular lens based on several different formulae.

Similarly, a database of intraocular lenses is also implemented. Before the calculation is made, the data for the desired lens must be entered.

ALADDIN also covers all the basic functions of corneal topography for recording some keratorefractive parameters.

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4 Precautions

This electronic instrument is a precision tool. Make sure to use it and keep it in a suitable place, at a normal temperature, humidity and atmospheric pressure out of direct sunlight.

 To ensure proper functioning, install the instrument in a vibration-free location.  Connect all cables correctly before use.  Use the recommended network voltage.  When the instrument is not in use, turn off the power supply and protect it from the sun and from

dust.

 To obtain accurate and reliable measurements, keep the measuring cone clean and free of dust.

This product conforms to the EMC standard (IEC 60601-1-2 3rd Edition).

- ELECTRICAL MEDICAL DEVICES require special EMC precautions and must be installed and activated

in accordance with the EMC instructions provided in the accompanying documentation.

- Portable RF communication instruments may interfere with medical devices.

- Use of accessories and cables other than those supplied with the instrument, except cables sold by

the equipment manufacturer as spare parts, may lead to an increase in emissions and reduce the device's or system's immunity.

- The eventual cables connected to USB and LAN ports must be less than 3 meters length.

- The device must not be used in contact with other devices.

If use of the device in contact with other instruments is unavoidable, check that the device works properly in the required configuration.

Caution should be practised when using the device’s ACD measurement for any given intraocular lens

calculation because of the high variability of this measurement.

The ACD measurement is the distance between corneal epithelium and the crystalline lens surface.

The FDA labelling for some IOLs contain sizing based upon white-to-white measurements derived from studies in which this measurement is done with callipers. It is unknown whether the white-to-white measurement from this device yields results systematically biased compared to those from calliper measurements. Thus, sizing based upon white-to-white measurements from this device may not be consistent with those based upon measurements with callipers.

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4.1 EMC table

Emission issues

ALADDIN is intended for use in the electromagnetic environment specified below. The customer or user must ensure that it is used only in such an environment.

Emission test

Compliance

Electromagnetic environment - guide

RF emissions CISPR 11

Group 1

ALADDIN uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in neighbouring electronic devices.

RF emissions CISPR 11

Class B

ALADDIN is suitable for use in all residential buildings and those directly linked to a low-voltage supply network that supplies residential buildings.

Harmonic Emissions IEC 61000-3-2

Class A Compliant

The device can be used in all buildings, including residential buildings and those connected to the low-voltage mains network that supplies residential buildings.

Emissions of voltage fluctuations/flicker IEC 61000-3-3

Compliant

Immunity issues

ALADDIN is intended for use in the electromagnetic environment specified below. The customer or user must ensure that it is used only in such an environment.

Immunity issues

Test level EN 60601-1-2

Compliance level

Electromagnetic environment - guide

Electrostatic discharge (ESD) EN 61000-4-2

 6kV on contact  8kV in air

The floors must be wood, cement or ceramic. If the floors are covered with synthetic material, relative humidity must be at least 30%.

Transients/fast electric Trains EN 61000-4-4

2kV power supply lines

2kV power

supply lines

The power supply should be typical of a commercial environment or hospital.

Surge EN 61000-4-5

1kV differential mode 2kV common mode

The power supply should be typical of a commercial environment or hospital.

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

< 5% U

(>95% dip in UT) for 0.5 cycle

40% U

(60% dip in UT) for 5 cycles

70% U

(30% dip in UT) for 25 cycles

< 5% U

(>95% dip in UT) for 5 seconds

< 5% U

(>95% dip in UT) for 0.5 cycle

40% U

(60% dip in UT) for 5 cycles

70% U

(30% dip in UT) for 25 cycles

< 5% U

(>95% dip in UT) for 5 seconds

The power supply should be typical of a commercial environment or hospital. If the user requires the device to operate continuously even during a power cut, we recommend powering the device with an uninterruptable power supply (UPS) or a battery.

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Immunity aspects at RF

The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device must ensure that it is used only in such an environment.

Portable and mobile RF communication devices must be used no closer to any part of the device, including the cables, than the recommended separation distance, calculated from the equation applicable to the frequency of the transmitter.

Immunity test

Test level EN 60601-1-2

Compliance level

Electromagnetic environment – guide

Recommended separation distance (where P is the maximum output power rating of the transmitter in Watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m)).

Conducted RF EN 61000-4-6

3 Vrms from 150kHz to 80MHz

d = 1.2 P from 150kHz to 80MHz

Radiated RF EN 61000-4-3

3 V/m from 80MHz to

2.5GHz

3 V/m from 80MHz to

2.5GHz

d = 1.2 P from 80 MHz to 800 MHz d = 2.3 P from 800 MHz to 2.5 GHz

Field strengths from fixed RF transmitters, as determined in an electromagnetic site survey, should be less than the compliance level in each frequency range. Interference may occur in the vicinity of equipment marked with the following symbol:

Recommended separation distance between portable and mobile radio communication devices and

the ALADDIN device

ALADDIN is intended for use in an electromagnetic environment in which radiated RF disturbances are under control. The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between mobile and portable RF communication devices (transmitters) and the ALADDIN device as recommended below, according to the maximum output power of the radio communication devices.

Maximum nominal output power of the transmitter (W)

Separation distance according to the frequency of the transmitter (m)

150kHz to 80MHz

d = 1.2 P

80MHz to 800MHz

d = 1.2 P

800MHz to 2GHz

d = 2.3 P

0.01

0.12

0.23

0.1

0.38

0.73

1.2

2.3

3.8

7.3

100

For transmitters with maximum output powers not listed above, the recommended separation distance d in meters (m) can be calculated using the equation applicable to the frequency of the transmitter, where P is the nominal maximum output power of the transmitter in Watts (W) according to the transmitter manufacturer.

Note: (1) At 80 MHz and 800 MHz the separation distance of the higher frequency range applies. (2) These guidelines may not be applicable in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

Power frequency magnetic field EN 61000-4-8

3 A/m

Power frequency magnetic fields must have levels characteristic of a typical commercial or hospital environment.

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5 Symbols

Symbols

IEC

publications

Description

IEC 60417-

5840

CLASS I DEVICE ACCORDING TO EN 60601-1 APPLIED PART TYPE B

PRODUCT COMPLIANT WITH DIRECTIVE 93/42/EC

Type A

EN ISO

19980

CORNEAL TOPOGRAPHY ACCORDING TO ISO 19980:2005

IEC 60417-

5032

ALTERNATING CURRENT

ISO 7010-

W001

GENERAL WARNING

EN ISO

15223-1

REFERENCE OR MODEL NUMBER

ISO 7010-

M002

FOLLOW THE INSTRUCTIONS FOR USE

EN ISO

15223-1

MANUFACTURER

Group 1

EN ISO

15004-2

PRODUCT CLASSIFIABLE AS GROUP 1 IN ACCORDANCE WITH EN ISO 15004-2

EN 62471

PRODUCT CLASSIFIABLE AS EXEMPT GROUP IN ACCORDANCE WITH EN 62471

EN ISO

15223-1

TEMPERATURE LIMITATION

Indicate the temperature limits to which the medical device can be safely exposed.

EN ISO

15223-1

HUMIDITY LIMITATION

Indicate the range of humidity to which the medical device can be safely exposed.

EN ISO

15223-1

ATHMOSPHERIC PRESSURE LIMITATION

Indicate the range of atmospheric pressure to which the medical device can be safely exposed.

EXEMPT GROUP

EN62471

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EN ISO

15223-1

KEEP DRY

Indicates a medical device that needs to be protected from moisture.

HANDLE WITH CARE

ISO 780

THIS WAY UP

Indicates correct upright position of the transport package.

This symbol is solely applicable for EC member countries.

To avoid potential negative consequences for the environment and possibly human health, this instrument should be disposed of (i) for EU member countries – in accordance with WEEE (Directive on Waste Electrical and Electronic Equipment) or (ii) for all other countries, in accordance with local disposal and recycling laws.

5.1 Labeling on the device

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6 Safety instructions

6.1 General

 ALADDIN should be used only for its intended purposes as detailed in this manual.  It must be installed by qualified personnel.  The device must be used in the environmental conditions as specified in this document.  The least favorable environment is defined as the maximum values of temperature for the unit to be

operating in, while the unit is consuming the maximum current. The environmental value is stated as +40°C. The maximum current absorption occurs during full biometry acquisition.

 The maximum temperature of applied parts (chinrest and headrest) can exceed 41°C when the device is

used at environmental temperature close to 40°C. The device temperature doesn’t exceed 48°C anyway.

Considering the examination duration, the patient condition and the parts that are in contact with the patient, there aren’t any known contraindications about to the contact with the device.

 If the device has just been delivered or has been subjected to thermal shock, wait at least one

hour before making measurements on patients.

 Keep this manual at hand close to the device at all times.  The physician or device user must inform the patient of the pertinent safety instructions and

ensure that they are adhered to.

 Connect the device to the supply mains using one of the cables supplied with the device  Position the unit so that it is not difficult to disconnect the plug for connection to the supply main.  Perform all the control functions (detailed in the relative section in this document) before carrying

out measurements on patients. In addition, if software interface shows an “Initializing error” warning, don’t go on with measurements. Also “Low repeatability of measure” warning originates a wrong IOL

calculation.

 Only personnel with the appropriate training and experience may use the device and interpret the

results.

 Turn off the device if it is not going to be used for a long period of time.  If external forces act on the device (e.g. if it is knocked or dropped), it must be thoroughly checked

before proceeding to examine patients. To do this, refer to the relative section in this manual. If necessary, send the device in for repair.

 Use only original ALADDIN accessories and spare parts specific for this device.  Remove all the covering (dust sheet) from the device before turning it on.  Do not use the device close to highly inflammable materials or in areas with an explosion hazard.

 Unauthorized installation of software in the device is forbidden.  After the examination, the patient may be slightly dazed. It is recommended to advise the patient

to wait a few minutes before driving or performing actions that require perfect vision.

 When operating the chinrest up/down switch, be careful not to pinch the patient’s hand. The

patient may be injured.

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6.2 Electrical safety

 To avoid risk of electric shock, this device must be connected to supply mains with protective

earth.

 ALADDIN has an on-board power supply unit installed. For connection to the mains, use only the

manufacturer-approved cables provided with the device.

 Before performing maintenance on the device, turn it off and disconnect the power cable.  Do not touch the LAB/USB ports contacts and the patient at the same time.

6.3 LED emission safety

The light emitted from this instrument is not potentially hazardous.

ALADDIN has a series of LEDs of various types and powers installed. All the characteristics are detailed in the Technical Specifications section in this manual. The LED groups comply with the emission limits for the Group 1 instruments of the standard UNI EN ISO 15004-2.

All sources are classifiable as EXEMPT GROUP according to EN 62471.

6.4 Installation with external devices or IT Network

ALADDIN complies with the CE marking requirements.

 Before connecting an external device, such as a computer, printer, monitor, keyboard, mouse or

other devices, make sure that they comply with the EN 60950-1 standard and have the CE marking.

 When ALADDIN is installed in rooms for medical use, the PC and the connected printer must be powered

by means of an IEC 60601-1 compliant insulating transformer.

 If ALADDIN is installed in rooms for medical use without a computer, it is not necessary to use an

insulating transformer.

 Do not use mobile phones or other devices not compliant with the requirements of class B EMC close to

ALADDIN.

 Every external device that has to be connected to ALADDIN must have a connection cable (USB or

LAN) with a maximum length of 3 m.

The purpose of ALADDIN connection to an IT network is report printing and remote technical assistance.  The ALADDIN USB port must be connected to printer with USB or LAN interface. Ask Topcon technical

assistance for printer driver installation.

 The ALADDIN can be connected to a Local Area Network (LAN) through the LAN connector. The network

must have Ethernet protocol (IEEE 802.3). Ask Topcon technical assistance and the system administrator for ALADDIN and network settings.

 The purpose of ALADDIN connection is saving PDF report on an external network folder or technical

service intervention on the machine.

 Connection of ALADDIN to a computer network that includes other equipment could result in previously

unidentified RISKS; identify, analyze, and control such RISKS (refer to IEC 60601-1:2005).

 Subsequent changes to a computer network could introduce new RISKS and require new analysis.

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 Changes to the computer network include:

 Changes in computer or data network configuration  Connection of additional items to computer network  Disconnecting items from computer network  Update of equipment connected to computer network  Upgrade of equipment connected to computer network  The term computer network used here corresponds to the term network/data coupling in IEC 60601-

1:2005.

6.5 Transport and packaging

 The device must be transported and stored in its original packaging.  For the storage and transport conditions, refer to the relative section in this document.  Carefully keep the original packaging in order to use it if you need to transport the device.  To move the device for short distances (without packaging) and to insert it in and remove it from the

original packaging, grip the device with both hands, one on the front headrest arch and the other in the recess on the rear of the device (where the locking system is).

 Completely unscrew the two transportation locks and the semi-lock (Figure 10) before use.

 Lower the instrument to its minimum height using the joystick, then lock ALADDIN using the

instrument semi-lock and the two “instrument locking devices” for transportation (Figure 10).

6.6 Cleaning

 Regularly clean dust off the device using a soft cloth. For more persistent superficial dirt, use a soft cloth

dampened with water or alcohol at maximum 70%.

 Be careful not to get the device wet and clean it only as indicated to prevent damaging it. Never

use solvents or other abrasive agents.

 The device comes with a dust cover to be used to protect it. Cover ALADDIN if it is not going to be used

for a long period of time.

 Before turning on the device, remove the cover. Never put the cover on when the device is on.

6.7 Package contents

 Power cable  Manual  Dust cover  Accessory for the calibration check

NB: keep the original packaging for storage or transport of the device.

6.8 Checking the measurements

 The calibration must be checked when the device has been transported from one place to another

and when it has suffered an impact or thermal shocks.

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 Check the measurements every day when turning on the device using the instrument provided.  The user of the device must check that the measurements provided by the device are plausible.  It is advisable to visually check all the light sources before examining patients to make sure that they

come on properly.

 If the device frequently emits error signals, turn it off and contact technical support to have the device

checked.

 In patients with blue eyes, acquisition of pupillometry in mesopic lighting conditions can be

difficult to accomplish. In this case, we suggest acquiring the mesopic data through dynamic pupillometry.

 Contact lenses must not be worn by the patient during data acquisition.

6.9 Cybersecurity

 When performing the installation of a new unit the user MUST set his own credentials to prevent

unauthorized physical access to the device.

 Make sure the USB devices you intend to connect to the instrument are secured against

malware/viruses.

 Patient data on USB devices can become corrupted when inserting into computers for backup or

transfer.

 The use of antivirus software on computers is recommended and it is responsibility of the user.  To protect data exported to USB from unauthorized access, use dedicated USB data for storage.  Installation of any unapproved software, including drivers, could degrade the performances of the

instrument and may void the instrument warranty.

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7 Product warranty and reliability

 The product warranty is valid only if all the instructions detailed in this document are followed.  The product warranty is forfeited in the event of loss or damage due to improper or incorrect use of

the device.

 The product warranty is valid only if it is equipped with its original accessories.  If the device is opened by unauthorized personnel, the manufacturer is relieved of all

responsibility and the warranty shall become null and void.

 N.B.: Modifications or repairs to the product, especially where they require opening the device, may

only be carried out by technical personnel authorized by the manufacturer.

8 Legal provisions

93/42/EEC – 2007/47/EC:  Class IIA medical device EN 60601-1:  Class I type B EN 60601-1-2:  EMC EN 15004-2:  Group 1 EN 62471:  All the sources are “EXEMPT GROUP” UNI EN ISO 19980  Type A

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9 Components

9.1 Main Body

Figure 2

Figure 3

LCD display with touchscreen

Joystick with acquisition button

Semi-lock

Instrument locking devices for transportation

Placido disk

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Figure 4

9.2 Other components

Figure 5

NB: The parts in contact with the patient (applied parts) are the forehead rest in Teflon and the chin rest in acrylonitrile butadiene styrene resin (ABS)

ON/OFF button

Forehead rest

Chin rest

Locking pins for chin rest papers

Wheel for adjusting the rest position

USB ports (2)

Power connector

(with fuse carrier)

LAN port

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10 Installation /uninstallation of the system

ALADDIN is packed for shipping in a double cardboard box on a dedicated pallet with specially shaped cardboard parts inside to guarantee instrument safety during shipment.

Two special warning labels are applied on the outside of the cardboard box. Please check them as

described below before accepting the instrument consignment, or accept it only with reserve.

If the circle on the label shown below is white, it means that the instrument has been handled without tipping. If it is red, the instrument may have been damaged during shipping.

If the white rectangle on the label shown above is red in the middle, it means that the instrument may have been damaged by shock during transport.

Keep the original packaging for future use. The system must always be moved/shipped in its original

packaging, which is specifically designed for damage protection.

10.1 Installing the system

Before installing the system, read the “Safety Instructions” in this manual.

Figure 6 shows the complete packaging of the instrument. Cut the extensible film and the packing straps. Open the external box, and remove the wood panel as shown in Figure 7.

Figure 6

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Figure 7

Remove the manual and the accessories from the dedicated spaces between the two pieces of cardboard (see Figure 8).

Figure 8

The accessories are:

 “Topcon” box:

o calibration checking device o chin rest paper o chin rest pins o touchscreen pen o silicon cloth

 Power cable  “Topcon” ALADDIN dust cover  ALADDIN user manual

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Open the internal box and remove the specially shaped cardboard that holds the instrument. The instrument can now be taken out of the package. The steps are illustrated in Figure 9.

Figure 9

Be careful when taking ALADDIN HW3.0 out of the box gripping it by the chin rest arch and the base

beside the joystick.

Remove the Nylon cover.

Place the instrument on a flat surface.

Completely unscrew the two transportation locks and the semi-lock (Figure 10).

Connect the power cable provided. The instrument is now ready for use.

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Figure 10

10.2 Uninstalling the system

Take the original packaging.

Set the instrument to the minimum height using the joystick. Lock the device using the instrument semi-lock and the two “instrument locking devices” for transportation (Figure 10).

Figure 11

Place the Nylon cover over the instrument and insert it in the box, as shown in Figure 11. Follow the sequence of steps shown in Figure 12.

Semi-lock

Instrument locking devices for transportation

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Figure 12

Put the accessories in the dedicated spaces. Position the wood panel with the shock absorbers in the lower part. Close the external box with strong packing tape or use extensible film and packing straps.

+ 117 hidden pages

Topcon ALADDIN User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual