Intended Use - OCULUS Pentacam AXL Instruction Manual

5 Intended Use

5 Intended Use
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Attention
Federal law restricts this device to sale by or on the order of a physician.
The Pentacam® AXL is designed to take photos of the anterior segment of
the eye which includes the cornea, pupil, anterior chamber and lens of the
eye. To evaluate:
 corneal shape,
analyze condition of the lens (opaque crystalline lens),

 analyze the anterior chamber angle,
analyze anterior chamber depth,

analyze the volume of the anterior chamber,

analyze anterior or posterior cortical opacity,

analyze the location of cataracts (nuclear, sub capsular and or

cortical), using cross slit imaging with densitometry,
corneal thickness,

axial length,

white-to-white distance.
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The Pentacam® AXL also performs calculations to assist physicians in
determining the power of the intraocular lens for implantation.
Intended medical indication
The Pentacam® AXL is indicated as an aid to screen several eye diseases
e.g but not limited to:
Keratoconus classification and progression

 Early ectatic diseases
Quantification of optical corneal density

 Quantification of optical lens density
Close angle glaucoma

Planning support for IOLs.

The Pentacam® AXL may only be used for the purpose described in this
instruction manual.

Heed the safety instructions listed above.
Instruction Manual Pentacam® AXL (G/70100/EN 1121 Rev04)