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Haag Streit Lenstar Eye Surgery Arizona

  Haag Streit LENSTAR®
Online Users Instruction Manual
 
IOL Power Calculations IOL Power Calculations
Optical Biometry Optical Biometry
Lens Constants IOL Master Lens Constants
Validation Guidelines
Haag Streit LENSTAR®
LENSTAR User Manual V.i2
Purpose of Use
Safety
Requirements
Program Functions Optical Biometry
Operation Optical Biometry
Abbreviations/Glossary
Troubleshooting
Zeiss IOLMaster® Zeiss IOLMaster
SIA Calculator
Disclaimer
Physician Downloads SIA Calculator
Links
References
Special Thanks
 

Haag Streit LENSTAR®.


Haag Streit Lenstar

Safety



EyeSuite Basic Module / Viewing Station

General

  • The appliance must only be used for the purpose described in this operating manual.
  • The software must only be installed by persons trained to do so.
  • The PC on which the EyeSuite software is installed must not contain or run any other software that might limit the functioning capabilities of EyeSuite.
  • Please keep this manual near the appliance at all times, in a place where it can be accessed easily by operating staff. Warranty claims will only be considered if the instructions in the operating manual have been followed as specified.
  • Only suitably-trained and experienced staff must operate the software (for the generation of measuring data and calculations, along with the manual entry, editing and deletion of data) and interpret results. All members of operating staff must be suitably-trained and familiar with the contents of the operating manual, with particular reference to the safety instructions contained in it.
  • Shut down the computer whenever the system is to be out of use for an extended period.

EyeSuite Biometry

General

  • Measurements can be carried out with dilated or undilated pupils. The A-scan (axial eye length, corneal thickness, anterior chamber depth, lens thickness), keratometry and white-to-white distance measurement are not influenced by dilatation status. Dilatation status does have a bearing on pupillometry.

Plausibility of Measurements

  • Users should check measurement readings for plausibility. This involves verifying the A-scan and the cursor, which is automatically adjusted with respect to signal peaks, whenever the LS 900 displays an abnormally-high standard deviation for axial eye length, corneal thickness, anterior chamber depth and/or lens thickness. The operator should also take into account the type (e.g. posterior subcapsular cataract) and density of the cataract when evaluating plausibility.
  • Measurement readings obtained from patients with a non-intact cornea (e.g. due to a corneal transplant, corneal opacity or corneal scarring) may possibly be inaccurate (this applies to keratometry in particular), and the user should check the data for plausibility.
  • We recommended the carrying-out of five measurements on each eye.
  • The user should ensure, before carrying out the measurement procedure, that the patient is not wearing contact lenses, as their presence is likely to give rise to incorrect measurement readings.
  • It may not be possible, under certain circumstances, to carry out measurements on persons with fixation problems.
  • Dense lenticular opacities may make it impossible to measure the axial eye length and lens thickness.
  • Pronounced opacities of the central cornea can likewise make it impossible to measure corneal thickness, anterior chamber depth, lens thickness or axial eye length.
  • Blood in the vitreous may make it impossible to measure the axial eye length.
  • Keratometry may be erroneous in eyes that underwent corneal refractive surgery because such eyes may significantly deviate from spherical surfaces.
  • The user should make a visual check, when carrying out the measurement procedure, to ensure that all light spots are present.
  • If the appliance repeatedly generates error messages, stop using it and contact customer service.
  • You are recommended always to examine both the patient's eyes. The user should subject the measurement readings to extra scrutiny if there is a notable difference between the right and left eye. The following are classed as notable differences:
    • More than 1 dpt with respect to central corneal refractive power -> 0.18 mm difference with respect to the corneal curvature radius
    • More than 0.3 mm with respect to axial eye length
    • More than 1 dpt with respect to emmetropic IOL refractive power
  • The user should check the A-scan when measuring anterior chamber depth in pseudophakic mode. If only one IOL signal is visible, it is not clear whether this signal relates to the front or back of the IOL. Uncertainty in this case can lead to the displayed reading for anterior chamber depth being inaccurate by the thickness of the IOL (approx. +/-1 mm).
  • An excessively tilted or decentered IOL may make it impossible to measure the anterior chamber depth and aqueous depth in pseudophakic eyes.
  • An intraocular pressure reading corrected on the basis of the measured corneal thickness does not in itself constitute a reliable diagnosis of glaucoma.
  • Ambient light has a bearing on pupil-diameter measurement readings. The user is responsible for ensuring the correct level of ambient light when carrying out pupillometry. The LS 900 cannot monitor ambient light, so do not use pupillometry as the decisive factor when considering keratorefractive surgery.
  • The white-to-white distance reading is merely an indirect measurement of the inner lateral dimensions of the anterior ocular section. It therefore provides only approximate indications of the actual inner lateral dimensions of the anterior ocular section and of the size of the implant used.

Statutory Requirements

  • CE designation certifies the conformity of the LS 900 biometer's software with European Directive 93/42 EEC (conformity module H). The software for the LS 900 makes it a class IIa device under the terms of this directive.
  • Haag-Streit can supply a copy of the European Declaration of Conformity for this product on request at any time.
  • The statutory accident-prevention regulations must be observed.

EyeSuite Imaging

General

See EyeSuite Basic Module


EyeSuite IOL

General

The measurements taken with the LENSTAR LS 900 are one central element of every IOL calculation. The other important part is the IOL constant used to calculate the power of an IOL to be implanted. Using LENSTAR, an optical non contact biometer, constants optimized for optical biometry should be used. Please contact the respective IOL Manufacturer to get information on optimized IOL constants for an individual set of lenses used. An alternative source for IOL constants optimized for optical Biometry is the home page of the "User Group for Laser Interference Biometry" (ULIB) of the University of Wuerzburg, Germany. Even though the constants published there have been optimized for a different optical biometer than the LENSTAR LS 900, recently published, peer reviewed studies [1, 2, 3] indicate that ULIB published data can be used to calculate IOL power in connection with the LENSTAR LS 900. To further improve the outcome of the IOL calculation, it is recommended that every surgeon creates personalized IOL constants based on pre-operative data generated with the LENSTAR LS 900 and data from a stable refraction analysis at least 3 month post-operative.

IOL Constants

It is recommended to use personalized IOL constants to achieve maximum prediction accuracy of the IOL calculation. Using personalized IOL constants minimizes the effects of individual surgical techniques, individual measurement- and surgical-equipment, ocular dimension and ethnic specialities of a patient population on the IOL calculation.

IOL constants derived using optical measurements

If there are optimized or even personalized IOL constants available from a different optical biometer than the LENSTAR LS 900, they may be used as well with the LENSTAR LS 900 to achieve clinically identical results [1,2,3]. Optimized constants for optical biometers can also be found on the web site of the "User Group for Laser Interference Biometry" (ULIB) of the University of Wuerzburg, Germany.

IOL constants derived using immersion ultrasound measurements

If there are optimized IOL constants available for immersion ultrasound, they may be used as a starting point for IOL Calculation with the LENSTAR LS 900. Still differences in IOL calculation may occur due to differences in the keratometry measurements of the LENSTAR LS 900 and the keratometer used in combination with the immersion ultrasound. A comprehensive manual how to convert existing ultrasound biometry optimized IOL constants to optical biometry optimized IOL constants can be found on the web site of the "User Group for Laser Interference Biometry" (ULIB) of the University of Wuerzburg, Germany. Still such converted data should only be used as a starting point to derive personalized constants.

IOL constants derived using contact ultrasound measurements

If there are optimized constants available for a contact ultrasound biometer in combination with a keratometer, respective IOL constants have to be converted into constants optimized for optical biometry. A comprehensive manual how to convert existing ultrasound biometry optimized IOL constants to optical biometry optimized IOL constants can be found on the web site of the "User Group for Laser Interference Biometry" (ULIB) of the University of Wuerzburg, Germany. Still such converted data should only be used as a starting point to derive personalized constants.

References

  • [1] P J Buckhurst, J S Wolffsohn, S Shah, S A Naroo, L N Davies, E J Berrow, "A new optical low coherence reflectometry device for ocular biometry in cataract patients", British Journal of Ophthalmology 2009;93:949-953
  • [2] M P Holzer, M Mamusa, G U Auffarth, "Accuracy of a new partial coherence interferometry analyser for biométrie measurements", British Journal of Ophthalmology 2009;93: 807-81
  • [3] K Rohrer, B E Frueh, R Wälti, I A Clemetson, C Tappeiner, D Goldblum, "Comparison and Evaluation of Ocular Biometry Using a New Noncontact Optical Low-Coherence Reflectometer", accepted for publication in Ophthalmology

EyeSuite Perimetry

General

  • The appliance must only be used for the purpose described in this instruction manual.
  • Note that condensation may form on the cold surfaces of the appliance if it is brought into the operating area from a colder place. If this occurs, leave the appliance to stand for an hour or two, and do not switch on until the temperature is equalized and the device has dried out.
  • All examination of patients, operation of the appliance and interpretation of the results obtained must be carried out by properly trained and qualified persons.
  • The appliance, which is installed on a height-adjustable support stand, is designed for medical use in a darkened room.
  • Please keep this instruction manual near the appliance at all times, in a place where it can be accessed easily by operating staff. Warranty claims will only be considered if the instructions in the manual have been followed as specified.
  • The doctor or medical professional operating the device must inform patients of the safety requirements that affect them, and ensure that these are followed.
  • Ensure that the appliance is only connected to a power supply that matches the specifications given on its type plate. Note that the ON/OFF switch DOES NOT shut off the mains power supply to the perimeter. Before carrying out cleaning or maintenance work of any kind, ensure that the appliance is unplugged from the mains power socket.
  • Do not use the appliance in explosion-hazard zones, and do not store volatile solvents (such as alcohol or benzene) or other flammable substances nearby.
  • Always remove the dust cover before switching on the power, as failure to do so may result in irreparable damage to the light sources.
  • In the same way, ensure that the appliance is switched off before covering it.
  • The removal of housing components and repairs must only be carried out by suitably-trained specialists who are qualified and authorised to do so. Attempts to carry out unauthorized repairs are likely to result in danger to operating staff and patients.
  • Use only original spares and accessories when carrying out repairs.

Ambient Conditions


Transport

Temperature -10°C to +55°C
Air pressure 700hPa to 1060hPa
Relative humidity 10% to 95%


Storage

Temperature -10C to +55°C
Air pressure 700hPa to 1060hPa
Relative humidity 10% to 95%


Usage

Temperature +15°C to +40°C
Air pressure 700hPa to 1060hPa
Relative humidity 20% to 75%


Mains Connection

  • Use only a type-approved, three-wire electric power supply lead. In order to lessen the risk of electric shock, this appliance must be properly grounded.
  • The plug, cable and ground connection to the power socket must be free of damage and in full working order.

Transporting Appliance

Keep the appliance in its original packaging when transporting over long distances. When moving over short distances, lift the device with both hands, holding it in the area around the lower cupola


Safety Requirements

  • The LENSTAR® appliance has been designed and manufactured in accordance with standards IEC / EN 60601-1, EN ISO 15004 and EN ISO 12866. Manufacture, testing, setup, maintenance and repair are carried out in conformity with the corresponding Swiss and international standards.
  • The appliance's CE designation shows the conformity of the OCTOPUS 900 with European Directives 93/42/EEC and 89/336/EEC, and conformity module A.
  • Haag-Streit can supply a copy of the corresponding European Declaration of Conformity on request at any time.
  • The statutory accident-prevention regulations must be observed.

Classification:

Norm IEC 60601-1 / EN 60601-1 The Perimeter OCTOPUS 900 conforms to equipment safety class I.
Application unit type B
Operating mode: Continuous operation
European Directive 93/42/EEC Class I


EMC

The LENSTAR® meets the electromagnetic compatibility requirements of IEC / EN 60601-1-2. The appliance is designed to keep the generation and emission of electromagnetic interference to a level that does not affect the normal operation of other items of equipment. The appliance is likewise designed to provide a certain level of resistance to outside sources of electromagnetic interference.


EyeSuite Tonometry

General

  • The permanent magnets for automatic detections OD/OS (available as an option) may be used only with the AT 900 D. Other measuring instruments, in particular mechanical tonometers, can be influenced by the magnetic field.
  • There is no absolute contraindication for the execution of the tonometry. Professional assessment and caution are appropriate.
WARNING: As far as possible, do not carry out an examination when eye infections or cornea injuries are present!

Warranty and Product Liability

  • This product left our factory in a perfect state of repair. If an incident should occur however, please contact your dealer.
  • The manufacturer supplies the appliance with a warranty. The warranty does not cover malfunctions or defects arising from incorrect use or external factors.
  • Any attempt to carry out unauthorized repairs will immediately void all warranty liability.
  • Personal injury may result if the PC on which the EyeSuite biometry software is installed contains or runs other software that is likely to limit the functioning capabilities of EyeSuite. The manufacturer will accept no liability whatsoever in such cases.
  • Continued use of a product that has been damaged by incorrect operation can lead to personal injury. The manufacturer will accept no liability whatsoever in such cases.
  • Failure to follow the instructions in this manual will void all warranty claims.
  • Before unpacking the product, check the outside of the packaging for signs of incorrect handling and possible damage. If you do detect such damage, please notify the carrier responsible for delivery, and unpack the appliance in the presence of a representative of the transport firm concerned. You should then make out a report detailing any damage detected. The report should be signed by you and the carrier's representative.

LENSTAR Help
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Haag Streit LENSTAR®

Optical Biometry

Intraocular Lens Power Calculations


East Valley Ophthalmology
5620 East Broadway Road
Mesa, Arizona 85206

Tel: +1-480-981-6111
FAX: +1-480-985-2426

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