Intended Use; Clinical Benefits; Essential Performance; Restrictions Of Use - Icare HOME2 Instruction Manual

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Intended use

The iCare HOME2 tonometer is a device intended for monitoring of
intraocular pressure (IOP) of the human eye. It is indicated for use by
patients or their caregivers.
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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.
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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.
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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.
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Restrictions of use

WARNING! The tonometer is intended for personal use only. Measuring other people,
animals, or objects is forbidden.
WARNING! Do not use the tonometer in the restricted environments defined in chapter
"5.2 Environmental restrictions" of this manual.
PRECAUTION! Use the tonometer only for measuring intraocular pressure. Any other use
is improper. The manufacturer is not liable for any damage arising from improper use,
or for the consequences of such use.
PRECAUTION! Do not use the tonometer near inflammable substances, including
inflammable anesthetic agents.
5.1

Contraindications

You should not use the iCare HOME2 tonometer if you:
• have an active ocular infection (for example, pink eye or infectious
conjunctivitis)
• have had a recent trauma to your eye including corneal laceration or
corneal or scleral perforation
• have disabling arthritis or difficulty handling the tonometer
• have severe difficulty with opening your eyes, including abnormal
contractions or twitches of the eyelid (blepharospasm)
• have involuntary, rapid, and repetitive movement of the eyes (nystagmus)
You may not be eligible for use of the iCare HOME2 tonometer if you:
• have poor uncorrected near vision of 20/200 or worse
• have only one working eye
• have poor or off-center visual fixation
• have poor hearing without an aid or communicate using sign language
• use contact lenses
• have dry eyes
• have keratoconus (a corneal disorder)
• have a congenitally (from birth) small eye (microphthalmos)
• have an enlarged eye from childhood glaucoma (buphthalmos)
The safety and effectiveness of the iCare HOME2 tonometer has not
been evaluated for patients with:
• high corneal astigmatism (>3d)
• history of prior invasive glaucoma surgery or corneal surgery including
corneal laser surgery (for example, LASIK)
• corneal scarring
• very thick or very thin corneas (central corneal thickness greater than
600 µm or less than 500 µm)
• whom it is already difficult to obtain clinical intraocular measurements
(for example, due to eyelid squeezing or tremor)
• cataract extraction within the last 2 months
5.2

Environmental restrictions

The iCare HOME2 tonometer should not be used in medical vehicles or
similar environments where the vibration or noise levels are so high that the
user cannot hear error signals.
See chapter "17.12 Electromagnetic declaration" for the correct
electromagnetic use environment.
NOTE! When not in use, keep the tonometer in the carrying case to protect it from dirt and
direct sunlight that might cause damage to the tonometer.
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