ALL-IN-ONEOptical Biometry, Dual Scheimpflug Tomography and Placido Topography

GALILEI G6 Clinical Applications

Corneal incision planning

With high definition pachymetry, high order aberrations and total corneal astigmatism data, GALILEI offers a complete set for a precise planning and positioning of arcuate incisions for astigmatism correction in conjunc-tion with cataract surgery.2

High confidence premium IOL selection

The GALILEI G6 offers a link to the ray-tracing software packages PhacoOptics and Okulix. By taking into account the true physical properties of the eye and total corneal astigmatism, ray-tracing is the ideal tool for precise toric IOL planning.1

IOL selection for post-refractive cases

GALILEI G6 is the first device on the market to combine the actual refractive data of the anterior and posterior corneal surfaces with intraocular distances and axial length measurements. With this complete dataset an exact ray-tracing of the eye can be performed to achieve accurate IOL power calculation in post-LASIK and long or short eyes.

In addition, the incorporated Shammas no-history formula for post-refractive cases enables a reliable IOL prediction even if no clinical history is available.3

The GALILEI G6 Lens Professional also enables you to perform a complete topographic screening for refractive surgery:

Corneal Implant Planning

Planning and follow-up of Keratoplasty

Keratoconus Screening

GALILEI G6 Unique Technology

Placido Topography

• Highly accurate anterior curvature data• Precise detection of anterior surface irregularities

and tearfilm quality

Optical Biometry

• State-of-the-art biometry measuring axial and intraocular distances in one exam session

• Lens thickness and precise anterior and posterior corneal power maps for next generation IOL planning

Dual Scheimpflug Tomography

• Precise pachymetry and elevation data• 3D anterior chamber analysis• Ray-traced posterior corneal surface data to detect

bulging and asymmetry in early stages

GALILEI G6Clinical Benefits

Workflow efficiency

In one measurement session the GALILEI G6 Lens Professional acquires Placido topography, Scheimpflug tomography and optical biometry data for a com- prehensive refractive and cataract screening. Acquiring and storing all clinical data in one device improves clinical workflow efficiency, reduces maintenance costs and saves office space.4

User friendly interface

The new software of the GALILEI G6 offers an intuitive user interface with a live-view image of the eye for precise alignment of the exam and a 5 step measure-ment guidance for an improved workflow. The GALILEI G6 will also fully interface with your EMR system.

Most complete dataset

By providing high definition pachymetry as well as total corneal wavefront, curvature and astigmatism data of the anterior and posterior cornea, GALILEI G6 offers a comprehensive dataset to plan refractive and cataract applications.5 Combined with optical biometry and a series of IOL calculation methods (Olsen PhacoOptics, Okulix, Shammas no-history), GALILEI G6 helps identify-ing the most suitable IOL for every patient.

GALILEI PRODUCT FAMILYThe modular solution for your needs

Refractive Software Package

GA

LILEI G4

GA

LILEI G4

Advanced

GA

LILEI G6

Refractive Report • • •

Keratoconus Report • • •

IOL Power Report • • •

Total Corneal Wavefront Report • • •

Curvature Topography • • •

Elevation Topography • • •

Densitometry • • •

Eye Metrics Report • • •

Map Comparison Report • • •

Optional Software Licenses

GA

LILEI G4

GA

LILEI G4

Advanced

GA

LILEI G6

IOL Calculator* • •

Corneal inlay module • •

DICOM/EMR connection • •

Remote workstation • •

CSV export for clinical studies • •

Z-LASIK Report • •

Santhiago PTA ReportTM

PhacoOptics / Okulix Connector** × ×

Cataract Software Package

GA

LILEI G4

GA

LILEI G4

Advanced

GA

LILEI G6

Biometry Report (including CCT, ACD, LT, AL) × × •

IOL Calculator* • •

Advanced IOL Report × × •

Images Report × × •

• Standard software package To be purchased separately

× Not available for this device

*IOL Formulae: Shammas no-history (post-refractive), Haigis, Holladay I, Hoffer Q, SRK I, SRK/T II

**IOL Calculation Software: The GALILEI G6 connects to the third party ray-tracing software PhacoOptics (phacooptics.com) and Okulix (okulix.de).

Please note: The Santhiago PTA ReportTM and the Z-LASIK Report are not available for sale in the US.

GALILEI G6System Information

Measurement Ranges

Axial Length: 14–40 mm (default 14–35 mm)

Central Corneal Thickness: 250–800 μm

Anterior Chamber Depth: 1.5–6.5 mm

Lens Thickness: 0.5–6.5 mm

Keratometry: 25–75 D (4.5–13.5 mm)

White-to-White: 6–14 mm

Pupillometry: 0.5–10 mm

Technical Data

Placido disc: 20 rings

Measurement speed: 60 images in 1 second

Number of measurement points – Scheimpflug/Placido:

up to 100 000 measurement points

Displayed map coverage: max. 10 mm

In-vivo Repeatability

Parameter SD specified SD measured

Axial Length: 0.050 mm 0.015 mm

Central Corneal Thickness: 3.00 μm 1.13 μm

Anterior Chamber Depth: 0.050 mm 0.015 mm

Lens Thickness: 0.100 mm 0.035 mm

Simulated Keratometry (SimK): 0.25 D 0.05 D

Angle of flattest meridian: 10 ° 3 °

White-to-White: 0.050 mm 0.024 mm

Measurement unit characteristics

Measuring principle: Combination of optical A-Scan, Dual Scheimpflug slit images and placido and top view images

Observation illumination: NIR (near-infrared) LED 810 nm

Scheimpflug illumination: Blue LED (UV-free) 470 nm

Placido illumination: NIR (near-infrared) LED 750 nm

Biometry wavelength: 880 nm

Image acquisition: 3 high definition CCD cameras

Classification according to IEC 60601-1

Type of protection against electric shock:

Class 1

Degree of protection against electric shock:

Type B applied part

Degree of protection against damaging penetration of water:

IP20

Electrical conditions

Power requirement: 100–240 VAC, 50/60 Hz, 400 W

Fuses (110/230 V): 2 × T6, 3 AH, 250 VAC

Study DesignInternal study of 24 normal eyes in 12 subjects, age range 26–53 years (mean = 38 years).Repeatability as estimated by the mean standard deviation of consecutive measurements averaged over all subjects and eyes.

AbbreviationsMean Arithmetic mean of consecutive measurements SD specified Specified repeatability as defined by the mean standard deviationSD measured Measured repeatability as estimated by the mean standard deviationSimK Keratometry corneal curvature over central area of diameter

1–4 mm

Ziemer Ophthalmic Systems AGa Ziemer Group CompanyAllmendstrasse 11CH-2562 Port, SwitzerlandPhone +41 32 332 70 50marketing@ziemergroup.com

www.ziemergroup.comgalilei.ziemergroup.com

Ziemer USA, Inc.a Ziemer Group Company620 E. Third StreetAlton, Illinois 62002, USAPhone +1 618 462 9301usa@ziemergroup.com

© 2015 Ziemer Ophthalmic Systems AGActual product characteristics, specifications, and prices are subject to change.

Issue Date: 2015-08Document No. CM3912-200-0003-06REF 410.931.014

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Ziemer Ophthalmology (Deutschland) GmbHa Ziemer Group CompanyIm Hausgrün 15DE-79312 Emmendingen, GermanyPhone +49 7641 9333860 info-deutschland@ziemergroup.com

Disclaimer: The GALILEI G6 Lens Professional is pending FDA approval and is not available for sale in the US. For some other countries, avail-ability may be restricted due to local regulatory requirements. Please contact Ziemer for details.

References

1 Hoffmann PC, Wahl J, Hütz WW, Preußner PR (2013). "A Ray Tracing Approach to Calculate Toric Intraocular Lenses" 29 (6): 402-408.

2 Pajic B (2013). "Planning a Procedure with LRIs" Supplement to Cataract and Refractive Surgery Today Europe October: 18-19.

3 Shammas HJ, Shammas MC (2007). "No-history method of intraocular lens power calculation for cata-ract surgery after myopic laser in situ keratomileusis." Journal of Cataract and Refractive Surgery 33 (1): 31-36.

4 Fam HB (2013). "The Advantages of an All-in-One System." Supplement to Cataract and Refractive Surgery Today Europe October: 5.

5 Zhang L, Sy ME, Mai H, Yu F, Hamilton DR (2015). "Effect of posterior corneal astigmatism on refractive outcomes after toric intraocular lens implantation" Journal of Cataract and Refractive Surgery 41 (1): 84-89.