Icare HOME2 - Restrictions of Use; Contraindications

9
5 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)
• have significant glaucomatous central field loss
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.