TOPCON
ALADDIN User Manual Rev 13 Feb 2013
User Manual
98 Pages
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Page 1
ALADDIN - User manual
Rev. 13 of 20/02/2013
ALADDIN User manual 0476
Rev. 13 - 2013
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ALADDIN - User manual
Rev. 13 of 20/02/2013
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.
Manufacturer
Distributor
VISIA imaging S.r.l. Via C. E. Gadda, 15 52027 San Giovanni Valdarno (AR) Italy
Topcon Europe Medical B.V. Essebaan 11 2908 LJ Capelle a/d IJssel The Netherlands www.topcon.eu [email protected]
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Contents 1
Intended Use... 7 1.1
Description of functionalities ... 7
1.2
Users... 8
1.3
Interaction with the patient... 8
1.4
Places of use... 8
2
Accessibility and scope of the manual ... 9
3
Introduction... 10 3.1
4
Main characteristics ... 10
Precautions ... 11 4.1
5
EMC table... 11
Symbols ... 14 5.1
6
Labelling on the device... 15
Safety instructions ... 16 6.1
General ... 16
6.2
Electrical safety... 16
6.3
LED emission safety... 16
6.4
Installation with external devices ... 17
6.5
Transport and packaging ... 17
6.6
Cleaning ... 17
6.7
Package contents ... 17
6.8
Checking the measurements... 18
7
Product warranty and reliability ... 18
8
Legal provisions ... 19
9
Components... 20 9.1
Main Body... 20
9.2
Other components ... 21
10
Installation /uninstallation of the system ... 22
10.1
Installing the system ... 23
10.2
Uninstalling the system ... 26
11
ALADDIN accessories and equipment... 29
11.1 12
Setting up the instrument ... 30
12.1 13
Standard equipment ... 29
Connection modes ... 30
OPERATING INSTRUCTIONS ... 31 3
ALADDIN - User manual 13.1
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General description of functionalities... 31
13.1.1
General instructions... 31
13.2
Checking the calibration... 32
13.3
Patient entry/selection... 34
13.3.1
Creating a new patient... 34
13.3.1.1
13.3.2
Entering s pecial characters: ...34
Selecting or modifying a patient ... 36
13.3.2.1
Open an examination or acquire data for the se lected patie nt ...36
13.3.2.2
Delete or edit the selected pa tient ...36
13.3.2.3
Insert the Post-Op (after s urgery) refraction data ...37
13.4
Acquisition environment: general instructions ... 38
13.4.1
Description of the Acquisition screen... 40
13.4.1.1
Errors in Measurements ...41
13.4.1.2
Biometry ...42
13.4.1.3
Pupillometry ...42
13.5
Full biometry acquisition (AL-ACD-K) ... 43
13.5.1
Acquisition procedure... 43
13.5.2
Manual acquisition of the anterior chamber... 44
13.6
Acquisition of axial length measurements (AL)... 45
13.7
Acquisition of the anterior chamber measurement (ACD)... 46
13.8
Keratometry acquisition (KER) ... 48
13.9
Acquisition of the dynamic, photopic, mesopic pupillometry ... 49
13.10
Report printing... 51
13.11
IOL CALCULATION... 52
13.11.1
Data ... 52
13.11.2
IOL CALCULATION ... 54
13.11.3
Toric IOL calculation... 56
13.11.4
Post Refractive IOL calculation... 58
13.12
MEASUREMENTS... 61
13.12.1
TOPOGRAPHIC MAP (KER) ... 61
13.12.1.1
Topographic map indices...62
13.12.1.2
Keratometry ...62
13.12.1.3
Keratorefractive indices ...62
13.12.1.4
Keratoconus ...63
13.12.1.5
Pupil...64
13.12.1.6
Profile ...64
13.12.2
Zernike ... 66 4
ALADDIN - User manual 13.12.3
AXIAL LENGTH (AL)... 68
13.12.4
ANTERIOR CHAMBER DEPTH (ACD) ... 69
13.12.5
PUPILLOMETRY (PUP)... 70
13.12.5.1
Display...70
13.12.5.2
Sequences ...70
13.12.5.3
Dynamic...71
13.12.5.4
Photopic, Mesopic ...71
13.12.5.5
Functions ...71
13.12.5.6
Graphs ...71
13.13
14
SETTINGS ... 75
13.13.1
General ... 75
13.13.2
Measurements ... 76
13.13.2.1
Scales ...76
13.13.2.2
Printer ...77
13.13.2.3
Pupillometry ...77
13.13.3
Surgeons ... 78
13.13.4
IOL ... 79
13.13.4.1
Disclaimer ...79
13.13.4.2
Preset...79
13.13.4.3
IOL list ...80
13.13.5
Report... 82
13.13.6
Admin ... 83
13.13.6.1
Updating the integra ted software ...84
13.13.6.2
Backup ...84
13.13.6.3
Restore ...84
13.13.6.4
Closing the software ...84
Operating voltage and fuse change... 85
14.1
14.2 15
Rev. 13 of 20/02/2013
Changing the operating voltage ... 85 14.1.1.1
Step 1...85
14.1.1.2
Step 2...85
14.1.1.3
Step 3...85
14.1.1.4
Step 4...86
14.1.1.5
Step 5...86
14.1.1.6
Step 6...86
Changing the fuse ... 87
Technical specifications... 88
15.1
General ... 88
15.2
Electrical data ... 88
15.3
Optical radiation... 89 5
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15.4
Information on measurements ... 90
15.5
Environmental conditions... 91
15.6
Mechanical Specifications... 91
15.7
Other Specifications:... 91
16
Declaration of conformity ... 92
17
Appendix: Installing an external printer... 93
17.1
Getting drivers and transferring them to ALADDIN... 93
17.2
Disable the Write Filter... 93
17.3
Installing a local printer (USB) ... 94
17.4
Installing a network printer (LAN) ... 97
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1 Intended Use “ALADDIN is intended for the biometric determination of ocular measurements for axial length (AL), corneal topography and keratometry (corneal radius and keratometric indices), corneal diameter (white-towhite), pupillometry (pupil size and deviation from the centre) and anterior chamber depth (ACD). For patients requiring an intraocular lens (IOL) implant, the device also supports physicians in the performance of calculations to determine the appropriate IOL power and type of implant. ALADDIN is intended for use by physicians and eye-care professionals and may only be used under the supervision of a physician. Use for any purposes other than those intended is the user's responsibility.
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 five types of measurement in a single instrument. • Axial length • Corneal topography and keratometry • Corneal diameter (white-to-white) • Pupillometry • Anterior chamber depth Axial length is the distance between the corneal apex and the fovea. It is measured with a low-coherence interferometry system with a super luminescent diode. The measuring range is from 15 mm up to over 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 around 80 millimetres from the patient's eye. With the acquisition of the corneal topography it is possible to determine the Corneal Diameter, also called "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 7
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latter is biggest. This measurement is performed using the reflection principle of a slit light projected onto the anterior surfaces of the eye. 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 ...
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.
1.3 Interaction with the patient The patient does not actuate the controls, is positioned with his/her chin on the chin rest and forehead on the forehead rest and is asked to keep still and to look with one eye at the fixation point. The patient may be elderly, disabled or a child, but the device is to be controlled by the aforementioned specialised personnel.
1.4 Places of use The intended places of use are: health care centres, doctors' surgeries, operating theatres.
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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.
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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 personalised intraocular lenses. It records a range of parameters acquired using different techniques. Optical Biometry: by means of the low-coherence optical interferometry method, ALADDIN executes highly accurate axial length measurements (between 1 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 using the latest methods. Topography: it is the only instrument (of all optical interferometric biometers) that allows the user to acquire a topographic map of the patient of approximately 6,200 points using a 24-ring Placido disk. This provides high accuracy and detail in the description of the corneal surface. This measurement also provides a kerometry at 3mm, 5mm and 7mm (with the respective corneal astigmatism). Pupillometry: to guarantee a further accuracy factor in the calculation of intraocular lenses, the instrument has a set of LEDs onboard that allows you to measure the Photopic, Mesopic and Dynamic pupillometry. White-to-White: as a result of the corneal topography, you can then, by means of an internal software algorithm, obtain a precise white-to-white value, i.e. the corneal diameter recorded at the limbus. On the basis of the measurements made, the instrument can propose a choice of intraocular lens power. This is based on internationally recognised formulae: Holladay 1, Haigis, Hoffer Q, SRK / T, SRK II, CamellinCalossi 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 topographies for recording the most important keratorefractive parameters.
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4 Precautions This electronic instrument is a precision tool. Make sure you use it and keep it in a suitable place, at a normal temperature, humidity and atmospheric pressure out of direct sunlight. • • • • •
To ensure that it works properly, install the instrument in a vibration-free location. Correctly connect all cables 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 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.
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
Emissions of voltage fluctuations/flicker IEC 61000-3-3
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.
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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
± 6kV on contact ± 8kV in air
Floors must be in wood, concrete or ceramic. If floors are covered with synthetic material, the relative humidity must be at least 30%
±2kV power supply
±2kV power
lines
supply lines
Transients/fast electric trains EN 61000-4-4
±1kV differential Surge EN 61000-4-5
Voltage dips, short interruptions and voltage variations on power supply input lines EN 61000-4-11
mode ±2kV common mode
±1kV differential mode ±2kV common mode
< 5% UT (>95% dip in UT) for 0.5 cycle
< 5% UT (>95% dip in UT) for 0.5 cycle
40% UT (60% dip in UT) for 5 cycles
40% UT (60% dip in UT) for 5 cycles
70% UT (30% dip in UT) for 25 cycles
70% UT (30% dip in UT) for 25 cycles
< 5% UT (>95% dip in UT) for 5 seconds
< 5% UT (>95% dip in UT) for 5 seconds
Power frequency magnetic fieldEN 61000-4- 3 A/m 8
Mains power quality must be that of a typical commercial or hospital environment.
Mains power quality must be that of a typical commercial or hospital environment.
Mains power quality must be that of a typical commercial or hospital environment. If the user requires the device to work continually even during a power cut, we recommend powering the device with an uninterruptable power supply (UPS) or a battery.
Power frequency magnetic fields must have levels characteristic of a typical commercial or hospital environment.
3 A/m
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RF 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 test
Test level EN 60601-1-2
Compliance level
Electromagnetic environment - guide
Conducted RF EN 61000-4-6
3 Veff 150kHz to 80MHz
3 Veff 150kHz to 80MHz
Portable and mobile RF communication devices must be used no closer to any part of the ALADDIN device, including the cables, than the recommended separation distance, calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance
Radiated RF EN 61000-4-3
3 Veff 80MHz to 2.5GHz
3 Veff 80MHz to 2.5GHz
d = 1.2 ⋅√P from 150kHz to 80MHz d = 1.2 ⋅√P from 80 MHz to 800 MHz d = 2.3 ⋅√P from 800 MHz to 2.5 GHz where P is the nominal maximum output power of the transmitter in Watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m).
Field strengths from fixed RF transmitters, as determined in an electromagnetic survey of the site, 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
80MHz to 800MHz
800MHz to 2GHz
d = 1.2 ⋅√P
d = 1.2 ⋅√P
d = 2.3 ⋅√P
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters with maximum output powers not listed above, the recommended separation distance d in metres (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.
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5 Symbols Symbols
IEC publications
IEC 60417-5840
Description
CLASS II DEVICE ACCORDING TO EN 60601-1 APPLIED PART TYPE B
WARNING: PART CONNECTED TO HIGH VOLTAGE (220-230V / 110-120V)
PRODUCT COMPLIANT WITH DIRECTIVE 93/42/EC
CORNEAL TOPOGRAPHY ACCORDING TO ISO 19980:2005
Type A
IEC 60417-5032
ALTERNATING CURRENT
EN ISO 15223-1
WARNING
EN ISO 15223-1
REFERENCE OR MODEL NUMBER
EN 60601-1
SEE USER MANUAL
EN ISO 15223-1
MANUFACTURER
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CLASS 1M LED PRODUCT
EN 60825-1
CLASS 1M PRODUCT ACCORDING TO EN 60825-1
EXEMPT GROUP EN62471
EN 62471
PRODUCT CLASSIFIABLE AS EXEMPT GROUP IN ACCORDANCE WITH EN 62471
LASER RAY HAZARD SIGNAL
This symbol is applicable to EU member states only. In order to prevent potential negative effects on the environment and on human health, this instrument must be disposed of (i) for EU member states, in accordance with WEEE provisions (Directive on waste materials including electrical and electronic devices), or (ii) for all other countries, in accordance with local recycling provisions and laws.
5.1 Labelling 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.
•
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.
•
Perform all the control functions (detailed in the relative section in this document) before carrying out measurements on patients.
•
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. It is advisable to use the device in an unlit environment, especially when measuring the anterior chamber depth.
• • •
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. 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 risk.
• •
Unauthorised installation of software in the device is not permitted. After the examination the patient may be slightly dazzled. It is recommended to advise the patient to wait a few minutes before driving or doing anything that requires perfect vision.
6.2 Electrical safety • •
ALADDIN has an onboard 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.
6.3 LED emission safety 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 device falls within class 1M according to EN 60825-1. All sources are classifiable as EXEMPT GROUP according to EN 62471. 16
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6.4 Installation with external devices 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.
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 5) 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 5).
6.6 Cleaning •
Regularly clean dust off the device using a soft cloth. For more persistent superficial dirt, use a soft cloth wetted 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
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NB: keep the original packaging for storage or transport of the device.
6.8 Checking the measurements •
It is absolutely essential to check calibration when the device has been transported from one place to another and when it has suffered an impact or thermal shocks.
•
It is recommended to 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. Before making measurements on patients, you need to know whether they are wearing contact lenses. If they are, some measurements might be incorrect. It is advisable to visually check all the light sources before examining patients to make sure that they come on properly.
•
7
•
If the device frequently emits error signals, turn it off and contact technical support to have the device checked.
•
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.
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 unauthorised 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 authorised by the manufacturer.
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Legal provisions
93/42/EEC – 2007/47/EC: EN 60601-1: EN 60601-1-2: EN 60825-1: EN 62471: UNI EN ISO 19980
Class IIA medical device Class I type B EMC Laser class 1M All the sources are “EXEMPT GROUP” Type A
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9 Components 9.1 Main Body
Placido disk
LCD display with touchscreen
Joystick with acquisition button
Semi-lock ON/OFF button Power connector (with fuse carrier) USB ports (2) LAN port Instrument locking devices for transportation
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