Icare HOME2, Инструкция по эксплуатации

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2 Intended use
The iCare HOME2 tonometer is a prescription device intended as an adjunct
to the routine clinical monitoring of intraocular pressure (IOP) of adult
patients.
3 Clinical benefits
With the iCare HOME2 tonometer, you can measure your eye pressure at
various times during the day and night. These measurements taken outside
your clinic visits may help your doctor better understand your eye pressure.
High-peak and mean eye pressure as well as large eye pressure fluctuations
are risk factors for glaucoma progression (1, 2). There may be eye pressure
peaks and fluctuations outside of office hours and those would remain
undetected without home eye pressure monitoring (3,4,5). Diurnal eye
pressure data helps in treatment decisions, for example, when evaluating the
success of a pressure-lowering procedure or the effect of topical medication
(6,7).
This eye pressure measurement tool is an adjunct to the standard of care
and does not replace the conventional methods used to diagnose and
manage patients, nor should it alter the follow-up schedule otherwise
indicated for a particular patient.
4 Essential performance
The essential performance of the iCare HOME2 tonometer is to measure
intraocular pressure with specified accuracy, to display the measurement
result or error conditions, and to transfer the data into the iCare software
system.
If the essential performance of the tonometer is lost or degraded due
to electromagnetic disturbances, the tonometer continuously displays
error messages during the measurement and asks you to repeat the
measurement. See chapter “17.12 Electromagnetic declaration” for
instructions on proper electromagnetic environment.
1) Asrani et al., “Large diurnal fluctuations in
intraocular pressure are an independent risk factor in
patients with glaucoma.” J. Glaucoma 2000;9(2):134-
142.
2) Cvenkel et al., “Self-monitoring of intraocular
pressure using iCare HOME tonometry in clinical
practice.” Clin Ophthalmol 13, 841-847 2019 May 10.
3) Barkana et al., “Clinical utility of Intraocular
pressure monitoring outside of normal office hours
in patients with glaucoma.” Arch. Ophthalmol.
2006;124(6):793-797.
4) Nakakura et al., “Relation between office
intraocular pressure and 24-hour intraocular
pressure in patients with primary open-angle
glaucoma treated with a combination of topical
antiglaucoma eye drops.” J Glaucoma 2007
Mar;16(2):201-4. 5) Hughes E et al., “24-hour monitoring of
intraocular pressure in glaucoma management: A
retrospective review.” J Glaucoma 2003:12(3):232-236.
6) Awadalla et al., “Using Icare HOME tonometry
for follow-up of patients with open-angle glaucoma
before and after selective laser trabeculoplasty.”
Clinical & experimental ophthalmology vol. 48,3
(2020): 328-333.
7) Astakhov et al., “The role of self-dependent
tonometry in improving diagnostics and treatment of
patients with open angle glaucoma.” Ophthalmology
Journal. 2019;12(2):41-46.