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EndoProbe and ENT Probe Operator Manual
13103F-EN
EndoProbe Specifications
Probe models
Standard and specialty EndoProbe and ENT probe handpieces are
available.
Sterile condition
The probes are single-use devices that have been factory pre-sterilized
using Ethylene Oxide (EtO) gas and are shipped in double-pouched, sterile
bags, ready for clinical use.
Illuminating EndoProbe specifications
In accordance with ISO 15752, Section 6.2 the following information
specific to the illumination capability of this device is provided:
EndoIlluminator effective aperture
0.6 mm
EndoIlluminator numerical aperture
0.5
EndoIlluminator light guide materials
PMMA acrylic plastic polymer or fused silica
Illumination testing
In accordance with ISO 15752, Section 4.4.2 the following information
specific to the illumination capability of this device is provided:
Measurement of the aphakic weighted irradiance of an illuminating
EndoProbe may be made under sterile conditions by using the means
provided for this purpose by the manufacturer of your EndoIlluminator
light source together with the use of a means to temporarily grip the
EndoProbe during measurement. This may be accomplished by draping
the EndoProbe handpiece with a sterile sleeve or alternatively by gripping
the EndoProbe with a sterile clamp, forceps, or gloves during
measurement. Be careful not to compromise the sterile tip of the
EndoProbe during fixturing or measurement.
Summary of Contents for EndoProbe
Page 1: ...EndoProbe and OtoProbe Operator Manual IRIDEX 13103 EN Revision F...
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Page 43: ...37 Clinical Safety 13103F EN Sample of an ENT sterile pouch label...
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