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Icare HOME tonometer Instruction manual for health care professionals
Icare HOME tonometer Instruction manual for health care professionals
2. INDICATIONS FOR USE
The Icare HOME tonometer is a prescription device intended as an adjunct to the
routine clinical monitoring of intraocular pressure (IOP) of adult patients.
3. CONTRAINDICATIONS
Patients with any of the following conditions should not be prescribed the HOME
tonometer:
1)
Active ocular infection including infectious conjunctivitis
2)
Recent ocular trauma including corneal laceration or corneal/scleral
perforation
3)
Inability to demonstrate proficiency with Icare Home tonometer after
training and failure to complete certification procedures. Patients for whom
initial agreement between GAT and HOME measurements in the clinic is
poor should not be prescribed the Icare HOME device for home use.
4)
Disabling arthritis or limited motor coordination affecting self-handling of
the Icare tonometer
5)
Blepharospasm
6)
Nystagmus
4. WARNING
Patients with the following conditions are generally not eligible for use of the HOME
tonometer as they have the potential to introduce unsafe conditions during use or
to impair measurement acquisition:
1)
Uncorrected near visual acuity of 20/200 or worse
2)
Only one functional eye
3)
Poor or eccentric fixation
4)
Hearing impairment to the extent that the individual cannot hear and
converse with others without an assistive aid and/or sign language
5)
Contact lens use
6)
Dry eyes
7)
Keratoconus
8)
Microphthalmos
9)
Buphthalmos
Cataract extraction within last 2 months
10)
5. PRECAUTION
The safety and effectiveness of the Icare HOME tonometer has not been evaluated for
patients with:
1) High corneal astigmatism >3d
2) History of prior incisional glaucoma surgery or corneal surgery including corneal
laser surgery
3) Corneal scarring
4) Central corneal thickness greater than 0.60mm or less than 0.50mm
5) Known history of difficulty in obtaining Goldmann IOP measurements or any
factors that might contribute to inaccurate Goldmann IOP measurements (e.g. lid
squeezing or tremor)
ENGLISH
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