User Manual
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IOLMaster 700
Documentation set
Copyright ©2018, Carl Zeiss Meditec AG, Jena Trademarks Microsoft Windows® is a registered trademark of Microsoft Corporation, Inc. SRK® is a trademark of Computational Technology, Inc. Hoffer ® is a registered trademark of Dr. Kenneth Hoffer. All other trademarks mentioned in this document are the property of their respective owners.
Content
User manual IOLMaster 700 [000000-1932-169-GA-GB-070218]
1
Appendix IOLMaster 700 – License activation [000000-1932-169-KurzGA01-GB-020118]
000000-1932-169-Inhalt0-GB-070218
IOLMaster 700
Instructions for use
Copyright © 2018, Carl Zeiss Meditec AG, Jena Trademarks Microsoft Windows® is a registered trademark of Microsoft Corporation, Inc. SRK® is a trademark of Computational Technology, Inc. Hoffer ® is a registered trademark of Dr. Kenneth Hoffer. All other trademarks mentioned in this document are the property of their respective owners.
Instructions for use IOLMaster 700
Table of contents
Table of contents 1
Notes on Instructions for Use... 7
1.1
Product name ... 7
1.2
Scope of application ... 7
1.3
Purpose and storage of the documentation ... 7
1.4
Questions and comments ... 7
1.5 1.5.1 1.5.2
Conventions in this document ... 7 Conventions in all text areas... 7 Conventions in a course of action... 8
1.6
Applicable documents ... 8
2
Safety notes ... 9
2.1
Intended user profile ... 9
2.1.1 2.1.2 2.1.3
Technicians or personnel performing measurements with the IOLMaster 700... 9 Physician’s assistants, nurses or other personnel performing data processing ... 9 Evaluation of measurement data ... 10
2.2 2.2.1 2.2.2
Intended field of application... 10 Intended use ... 10 Instructions and precautions to avoid measuring errors ... 10
2.3 2.3.1
Responsibilities and duties of the operator ... 11 Notification to manufacturers and authorities... 13
2.4
Responsibilities and duties of the operator ... 13
2.5
Risks due to optical radiation ... 15
2.6
Software installation ... 15
2.7
Network connection ... 16
2.8
Maintenance measures... 16
2.9
Product-specific risks... 17
3
Description of the device... 19
3.1
Package check list ... 19
3.2
Device marking... 20
3.3 3.3.1 3.3.2 3.3.3 3.3.4 3.3.5
Structure of the device ... 22 View from physician’s side... 22 View from patient’s side... 23 Connector panel of IOLMaster 700... 24 Connector panels of the touch screen monitors... 25 Operator interface composite cable... 26
3.4
Functional description ... 27
4
Installation ... 29
4.1
Installation safety ... 29
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Table of contents
Instructions for use IOLMaster 700
4.2
Prepare for installation... 30
4.3
Connect the device ... 30
4.4
Installing the stray light protective cover for the Reference Image Option... 32
5
Daily startup... 33
5.1
Switch the device on ... 33
6
Before every use... 35
6.1
Preparation safety ... 35
6.2 6.2.1 6.2.2 6.2.3 6.2.4 6.2.5
Calibration test ... 35 Calibration test - start window ... 36 Calibration test – step 1... 37 Calibration test – step 2... 40 Calibration test – step 3... 41 Results of the calibration test ... 42
7
Operation ... 45
7.1
Operation safety... 45
7.2
IOL database ... 47
7.3
Backup data ... 47
7.4
Exporting raw data... 47
7.5
Switching off the device ... 48
8
Software description ... 49
8.1 8.1.1 8.1.2
General operating instructions ... 49 Touch screen operation ... 49 Operation using the optional USB keyboard and mouse ... 50
8.2 8.2.1 8.2.2
Patient... 50 Patient / Measurements... 51 Patient / Patient details... 54
8.3
Advanced search ... 57
8.4
Advanced MWL search ... 58
8.5 8.5.1 8.5.2
Measure ... 60 Take measurements ... 60 Quality check... 68
8.6
Analyze... 75
8.7
IOL calculation... 82
8.8 8.8.1 8.8.2 8.8.3 8.8.4 8.8.5
Application guidelines ... 88 Notes on OCD measurement (CCT, ACD, LT, AL) ... 88 Notes on keratometry ... 90 Notes on white-to-white measurement ... 94 Notes on fixation check scan ... 95 Notes on images for the reference image ... 96
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Instructions for use IOLMaster 700
Table of contents
8.8.6 8.8.7 8.8.8
Notes on IOL calculation ... 99 Information on printouts ... 113 Export reference image for ZEISS Cataract Suite markerless ... 124
8.9 8.9.1 8.9.2 8.9.3 8.9.4 8.9.5 8.9.6 8.9.7 8.9.8
Settings ... 126 Menu bar ... 126 System information ... 127 General settings ... 130 Advanced settings ... 135 Network... 154 Maintenance ... 160 User management ... 166 Licenses... 170
9
Cleaning and disinfection ... 173
9.1
Safety when cleaning and disinfecting the device ... 173
9.2
Cleaning ... 173
9.3
Disinfection ... 174
10
Maintenance ... 175
10.1
Testing electrical safety ... 175
10.2
Replacing the fuses... 176
10.3
Remote maintenance (optional)... 177
11
Troubleshooting... 179
11.1 11.1.1 11.1.2 11.1.3
Errors (no messages)... 179 Problems with the electric system... 179 Monitor problems ... 179 Problems with the flexible optical measuring head ... 180
11.2
Service information ... 180
12
Technical specifications... 181
12.1
Essential performance ... 181
12.2 12.2.1 12.2.2 12.2.3 12.2.4 12.2.5
Compliance... 181 Guidelines with which the device is compliant ... 181 The device fulfils the requirements of the following standards... 181 Device classification... 181 Classification of the device in accordance with IEC 60825-1:2007 ... 181 RoHS Conformity... 182
12.3
Electrical specifications... 182
12.4
Dimensions and weights... 182
12.5
Measurement ranges and standard deviation of repeatability on the human eye ... 182
12.6
Comparability of IOLMaster 700 with IOLMaster 500 for calculation of IOL powers... 183
12.7
Optical data... 185
12.8
Ambient conditions ... 186
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Table of contents
Instructions for use IOLMaster 700
12.9 12.9.1 12.9.2
Electromagnetic compatibility ... 186 Ambient conditions for intended use... 187 Restrictions on essential performance... 187
13
Optional accessories... 191
13.1
Instrument table ... 191
13.2
Mouse and keyboard ... 191
13.3 13.3.1 13.3.2
Connecting a printer to IOLMaster 700 ... 192 Peer-to-peer connection of printer with IOLMaster 700... 192 Connection of printer via an existing network ... 192
13.4
Network isolator ... 193
14
Disposal ... 195
14.1
Disposal of the device... 195
15
References ... 197 Glossary ... 199 Index ... 201
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000000-1932-169-GA-GB-070218
Instructions for use IOLMaster 700
1 Notes on Instructions for Use 1.1 Product name
1 Notes on Instructions for Use 1.1 Product name IOLMaster 700 is referred to as "device" in these instructions for use.
1.2 Scope of application The present instructions for use apply to IOLMaster 700 with the following marking: • Reference number: 1932-169
1.3 Purpose and storage of the documentation These Instructions for Use explain the safety features, functions and performance parameters of the device. They contain instructions on the safe use of the device and identify measures for its care and maintenance. Correct operation of the device is imperative for its safe and successful function. u
Read these Instructions for Use before setting up and using the device the first time.
u
Keep the Instructions for Use accessible for all users at all times.
u
Pass the Instructions for Use to future owners of the device.
1.4 Questions and comments u
If you have any questions or comments concerning these Instructions for Use or the device itself, please contact ZEISS Service.
You can find the ZEISS contact partner for your country on the following website: www.zeiss.com/med
1.5 Conventions in this document Certain types of information are specially marked in this document for better recognition.
1.5.1 Conventions in all text areas • This is a list. – This is a second level list. This is a cross-reference: Questions and comments [} 7]. This is bold type. This is software code or program text.
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1 Notes on Instructions for Use 1.6 Applicable documents
Instructions for use IOLMaster 700
Names of software dialogs, fields or menus, and software messages are marked by quotation marks: • "View" menu. • "Do you want to save the settings?" The steps in menu and file paths are separated by slashes: • "File / Save as" • "My documents / Documents" Keys, buttons, knobs, levers and other operating controls are marked by square brackets: • [START] key • [Next] button
1.5.2 Conventions in a course of action
WARNING!
This is warning information about hazards that can cause death or severe injuries if not avoided. The warning message names the possible consequences. u
CAUTION!
This is a measure with which hazards can be prevented.
This is warning information about hazards that can cause injuries if not avoided. The warning message names the possible consequences. u
NOTE
This is a measure with which hazards can be prevented.
This is warning information about hazards that can cause property damages if not avoided. The warning message names the possible consequences. u
This is a measure with which hazards can be prevented.
þ This is a requirement that must be met before the start of a sequence of actions. 1. This is a command. 2. CAUTION! This is a warning message about hazards that can occur during a single action. This is a command. ð This is the result of a sequence of actions.
1.6 Applicable documents Documents Instructions for use of components and accessories
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Instructions for use IOLMaster 700
2 Safety notes 2.1 Intended user profile
2 Safety notes 2.1 Intended user profile This device may only be installed, operated, used and maintained by persons who have been properly trained or who have the required knowledge and experience to do so. Please also adhere to the national qualification guidelines applicable in your country. Persons who operate the device must have a basic knowledge of ophthalmic examination and diagnosis methods. It is recommended that the operator of the IOLMaster 700 has the following skills:
2.1.1 Technicians or personnel performing measurements with the IOLMaster 700 • Performs medical (eye) history and screening procedures • Provides patient instructions during measurement procedures • Observes acoustic and optical warning signals and displays on medical devices • Familiar with the use of computers and computer interfaces (USB, Ethernet, VGA) • Familiar with the Microsoft Windows operating system and applications based on it • Performs cleaning and calibration procedures on medical devices
2.1.2 Physician’s assistants, nurses or other personnel performing data processing In addition to the skills required for performing measurements, the user should have knowledge of pathological factors that influence measurement quality, in particular: • Cataract-related light scattering of optical media • Corneal opacity-related light scattering of optical media • Optimization of device settings, to minimize pathological factors that influence measurement quality • Handling of standard measurement protocols and measurement results in optics/optometry such as refraction values (sphere, cylinder, axis), ophthalmometer values (corneal radii), eye length, anterior chamber depth, WTW, corneal thickness and lens thickness. • Evaluation of the quality of readings with the aid of information provided in the instructions for use
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2 Safety notes 2.2 Intended field of application
Instructions for use IOLMaster 700
2.1.3 Evaluation of measurement data Evaluation of measurement data should be performed by physicians (e.g. ophthalmologist, cataract surgeon, refractive surgeon) using the instructions provided in these instructions for use. Users should not rely solely on measurements made using the IOLMaster 700 in making decisions regarding the calculation and implantation of intraocular lenses or other therapeutic procedures, but should rely on their own expertise and judgment.
2.2 Intended field of application This device may only be set up, operated and used for the specified purpose and according to national regulations, consistent with the applicable industry standards and occupational safety and accident prevention regulations.
2.2.1 Intended use The device is to be used only for the visualization and measurement of eye structures such as axial length, anterior chamber, eye lens, retina, pupil and for the determination of corneal curvature and thickness, white-to-white distance (WTW) of the human eye and calculation of the required intraocular lens. The Option Reference Image may only be used in conjunction with the IOLMaster 700 to capture images in which sclera vessels in the vicinity of the limbus are discernible in combination with the superposition of principal meridian of corneal curvature measurement.
2.2.2 Instructions and precautions to avoid measuring errors • Measurement should never be performed through contact lenses as this produces incorrect results. Intraocular lenses should not be calculated on the basis of such measurements. • The wearing of rigid or soft contact lenses may have an effect on the surface geometry of the cornea and thus the optical state of the eye. For measurements conducted on wearers of soft lenses using IOLMaster 700, a rest period of at least two weeks should thus be observed from the time the contact lens is removed to the time of measurement. For wearers of rigid lenses, the time from removal of the lens to the time of measurement should be at least three weeks. • Avoid the use of eye drops prior to measurement, as they may lead to incorrect results, in particular in the measurement of corneal curvature.
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Instructions for use IOLMaster 700
2 Safety notes 2.3 Responsibilities and duties of the operator
• Do not perform any contact measurements or examinations in which the eye is touched. They may result in incorrect readings, particularly for axial length and corneal curvature measurements. Contact measurements or examinations should only be performed after the patient has been measured with the IOLMaster 700. • Patients who are unable to sit upright in front of the device or patients with forehead or chin injuries which prevent the head from being supported on the forehead / chin rest, should not be examined with the device. • Poor measurement result quality can be expected in the following categories of patient: – The patient is unable to steadily fixate the fixation lights with the eye under examination (e.g. in the case of nystagmus, extremely poor visual acuity, lack of concentration, tremor or shortness of breath). – The patient is unable to follow the instructions of the user. – Patients with deficient specular reflection of the cornea for keratometry measurements (e.g. distortion of the tear film, scarring or caustic burn of the cornea). – Patients with complete or partial coverage of the cornea, caused by palpebral fissure which is closed or too small. • In patients with morphological changes of the retinal anatomy in the region of the fovea (e.g. retinal detachment, edema, staphyloma), the axial length measurement result may be erroneous and thus is not usable or only of limited use for IOL calculation. • In the case of low transparency of the optical media of the eye (e.g. corneal opacities, dense cataract, opacity of the posterior capsule, hemorrhage in the vitreous body) it may be difficult to measure biometric parameters of the cornea, anterior chamber, lens or axial length. • Axis and refractive power values of the IOLMaster 700 may not be used for patients with irregular corneal astigmatism, in particular for toric IOLs. • Correct detection of boundary layers in the B-scan should be checked with particular care when measuring very long eyes, eyes with dense cataracts, pseudophakic or aphakic eyes, eyes with any kind of pathology. Despite various plausibility checks, measuring errors cannot be excluded in individual cases.
2.3 Responsibilities and duties of the operator Operating personnel The device may only be operated by instructed and trained personnel.
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2 Safety notes 2.3 Responsibilities and duties of the operator
Instructions for use IOLMaster 700
u
Ensure that the operating personnel have been trained and instructed.
u
Ensure that the operating personnel have read and understood the instructions for use.
u
The instructions for use should be readily accessible to the operating personnel at all times.
u
To facilitate access for the entire operating personnel: If necessary, request further copies of the instructions for use from ZEISS.
u
Define the required skills for handling the device and provide information on who is authorized for which activities.
u
Define rules for reporting errors and damage, and provide information on this (see Notification to manufacturers and authorities).
u
Regularly check compliance with the national laws and regulations concerning accident prevention and occupational health.
Safety inspections u
To prevent any reduction in device safety due to aging and wear: Have regular safety inspections performed which are set in accordance with the applicable national regulations for this device.
Safety inspections may be carried out only by the manufacturer or persons authorized by the manufacturer. u
Keep within the prescribed deadlines.
u
Perform the inspections to the prescribed extent.
The following safety inspections and checks should be performed as a minimum for the device: • Check the presence of the instructions for use • Visual inspection of the device and its accessories for damage, as well as legibility of markings and labels • Leakage current test • PE conductor check • Check the ventilation slits of the device. They should be covered or obstructed. • Functional check of all switches, buttons, connectors and control lamps on the device • Performing a calibration test Service life The development, production and maintenance of this device, together with associated risks, are based on an expected service life of eight years, assuming that the device is operated and maintained as prescribed by the manufacturer.
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Instructions for use IOLMaster 700
2 Safety notes 2.4 Responsibilities and duties of the operator
Maintenance and inspection u
To ensure safe operation of the device and to reach the expected service life: Observe the maintenance and inspection intervals that are specified in these instructions for use.
Changes to the product Modifications to the product or failure to follow the manufacturer’s instructions may substantially reduce the expected service life and significantly increase the risks associated with the use of this device and are thus not permitted. Accessories and additional equipment u
If you want to connect accessories or additional equipment to the device: Contact ZEISS [} 7].
Additional equipment connected to medical electrical equipment must comply with the corresponding IEC or ISO standards (e.g. IEC 60950 for data processing equipment). Furthermore all configurations must comply with the normative requirements for medical systems (see IEC 60601-1-1 or section 16 of the 3rd edition of IEC 60601-1). If you connect additional devices to medical electrical systems, you are a system configurer and are thus responsible for ensuring that the system complies with the normative requirements for systems. Local laws take precedence over the abovementioned normative requirements.
2.3.1 Notification to manufacturers and authorities If an incident occurs in connection with this medical device affecting the operator or another person, the operator (or person responsible) must report this incidence to the manufacturer or seller of the medical product. In the European Union, the operator must report this incident to the responsible authorities in the applicable country.
2.4 Responsibilities and duties of the operator Electrical safety
000000-1932-169-GA-GB-070218
u
Switch the device off every time before disconnecting it from the power supply or if you are not going to use the device for any length of time. Also disconnect the device from the power supply before cleaning surfaces or accessories.
u
Insert the power plug only into a power outlet that has a functioning protective earth connection.
u
Use only cables and plugs which are in perfect working condition.
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2 Safety notes 2.4 Responsibilities and duties of the operator
Instructions for use IOLMaster 700
u
Connect the device only to a power supply that corresponds to the values specified on the rating plate.
u
Do not use multiple sockets.
u
Do not use extension cables.
u
Do not touch the device when your body is charged electrostatically and the unit is not grounded.
u
Observe the instructions regarding electromagnetic compatibility (EMC).
u
Set the device up so that the power cable can be disconnected from the power supply quickly and without any supplementary means.
u
Connect the device using the power cable intended for use with the device. If the device is mounted on the instrument table, it will be powered through this table.
u
Perform the electrical installation in conformance to IEC 60364-7-710 or the applicable national regulations. This includes the integration of a ground fault circuit interrupter (GFCI).
u
Do not touch the patient and the connections of the device simultaneously.
Live parts are accessible inside the device. If you remove the housing, you are exposed to the risk of an electric shock. u
Never open the device!
Ambient conditions u
Make sure that the installation requirements and the operation of the device meet the following requirements:
• Low vibration • Clean environment • Avoid extreme mechanical loads u
Do not operate or store the supplied devices in environmental conditions other than those prescribed.
u
Operate the device only on a table with an even table top to allow for ventilation at the bottom of the device. Make sure that no papers or other objects have been placed under the device.
u
Do not operate the supplied devices when powered by electricity,
• on easily inflammable materials, • in explosion risk areas (e.g. combustible mixture of anesthetic, cleaning or disinfecting agents with air, oxygen or nitrous oxide). u
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Do not store or use this device in damp areas. Do not expose the device to water splashes, dripping or sprayed water.
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Instructions for use IOLMaster 700
2 Safety notes 2.5 Risks due to optical radiation
u
Ensure that no liquids can enter the device.
Decommissioning u
If one of the following events should occur, disconnect the cable from the power supply, label the instrument clearly as being out of service and report the problem to the ZEISS service:
• Defective sensor for right / left detection (right / left labeling may be incorrect) • Electric shocks • Penetration of substances • Frequently occurring error messages • Faults that cannot be remedied based on the information provided in these instructions for use Symbols and labels u
Observe the symbols and labels attached to the device.
Transport u
Transport the unit over long distances (e.g. move, return for repair, etc.) only in original packaging or special return packaging.
u
Contact your dealer or ZEISS Service.
u
To lift the device, use only the recessed grips provided at the bottom of the head rest and at the base of the device. Never lift the device by the measuring head or by the head rest itself.
2.5 Risks due to optical radiation The light emitted from this instrument is potentially hazardous. The longer the duration of exposure, the greater the risk of ocular damage. Exposure to light from this instrument when operated at maximum intensity will exceed the safety guideline after 27 min. As the respective light source (illumination of the reference image) is only switched on for 0.5 seconds during measurement, this corresponds to more than 3,000 measurements of the same eye. u
Do not extend the length of use of the device for the eye examinations unnecessarily.
u
The number of measurements will not be limited by the device. Note that the total measuring length is limited to 30,000 s per eye per day.
2.6 Software installation u
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Install only software authorized by Carl Zeiss Meditec in this device.
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2 Safety notes 2.7 Network connection
Instructions for use IOLMaster 700
u
Activate the user administration (administrator rights required) in order to prevent access to the device and readings by unauthorized persons.
u
Assign the appropriate access rights to the persons authorized to use the device.
u
Note that a forgotten administrator password can only be recovered by ZEISS Service!
u
Ensure that the assigned passwords are protected from unauthorized access. Unauthorized persons may under no circumstances use the service password. This will invalidate the safety warranty for the medical device IOLMaster 700.
2.7 Network connection The IOLMaster 700 can be included into an Ethernet network to perform the following applications: • Print • DICOM export or import • PDF file export to a shared network drive Use a network Isolator (cut-off voltage of at least 4 kV) when connecting the device to a LAN and connect the device only to private networks which are protected from public networks (the internet) by a firewall which meets the latest technical requirements. Connecting the unit to an IT network that includes other devices could lead to unforeseen risks for patients, users and third parties. The responsible organization should determine, analyze, evaluate and manage these risks by taking appropriate measures. (IEC 80001-1:2010 includes instructions on addressing these risks.) Similarly, subsequent changes to the IT network can lead to new risks and therefore require additional analysis: • Changes to the IT-network configuration • Connection of additional elements to the IT network • Removal of elements from the IT network - update or upgrade of devices that are connected to the IT network u
The configuration and network settings should only be changed by a network administrator with experience.
2.8 Maintenance measures Maintenance procedures (maintenance and repairs) which are not specified in these instructions fro use may only be carried out by persons authorized by Carl Zeiss Meditec and solely according to the service instructions issued by Carl Zeiss Meditec. For planning and implementing these maintenance and care procedures please contact ZEISS service or your local dealer.
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Instructions for use IOLMaster 700
2 Safety notes 2.9 Product-specific risks
2.9 Product-specific risks Responsibility of the operator Users should not rely solely on measurements made using the IOLMaster 700 in making decisions regarding the calculation and implantation of intraocular lenses or other therapeutic procedures, but should rely on their own expertise and judgment. Maintain stable fixation. Unstable fixation can lead to measuring errors and the calculation of incorrect IOL refractive powers. Check the correct position of all measurement marks. In case of incorrect positioning, there is a risk of measuring errors. This can lead to the calculation of incorrect IOL refractive powers. When editing values, the user is responsible for the correctness and precision of the values, especially when entering keratometry values manually. The IOL calculation is valid only if the biometric measurement was correct, an appropriate IOL calculation formula was selected and the IOL constants were optimized for the specific application in advance. Using IOL constants Subject to the lens type, the constants must be defined and entered prior to using the IOLMaster. Your IOLMaster does not have its own constants; they are physician-specific and contingent on individual circumstances. In particular the diagnostic and surgical methods may result in differing corrective factors for calculation. The constants should thus be subjected to regular review and refinement. Special remarks on phakic or piggy-back IOLs or pseudophakic eyes When measuring phakic IOLs and piggy-back IOLs, the measurement of anterior chamber depth and lens thickness will be inaccurate and may not be used for IOL calculation. When measuring pseudophakic eyes, the measurement of anterior chamber depth and lens thickness may be inaccurate depending on the intraocular lens - especially in case of PMMA-IOL. The measurement marks should be checked very carefully to ensure correct positioning. Artifacts in OCT scans Occasionally, the following artifacts may be visible in the crosssectional images (OCT measurement):
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