Contraindications; Risks; Benefits; Package Contents - icare HOME TA022-088-3.1 Manual De Instrucciones

4
The Essential Performance of the Icare HOME (TA022) tonometer is to
measure the intraocular pressure (IOP) with specified accuracy (section 18)
and transfer the data (section 12).
5.

CONTRAINDICATIONS

You should not use the HOME tonometer if you:
1. Have an active ocular infection (for example, pink eye)
2. Had recent trauma to your eye
3. Have disabling arthritis or difficulty handling the Icare tonometer
4. Have a severe difficulty in opening your eyes including abnormal
contractions or twitches of the eyelid
5. Have involuntary, rapid and repetitive movement of the eyes
6.

RISKS

You may not be eligible for use of the HOME tonometer if you:
1. Have poor uncorrected near vision
2. Have only one working eye
3. Have poor or off-center visual fixation
4. Have poor hearing without an aid and/or communicate using sign
language
5. Use contact lens
6. Have dry eyes
7. Have Keratoconus (a corneal disorder)
8. Have a congenitally (from birth) small eye
9. Have an enlarged eye from childhood glaucoma
The safety and effectiveness of the Icare HOME tonometer has not been
evaluated for patients with:
1. High corneal astigmatism
2. History of prior invasive glaucoma surgery or corneal surgery including
corneal laser surgery (for example, LASIK)
3. Corneal scarring
4. Very thick or very thin corneas
5. Patients for whom there is already difficulty in obtaining clinical IOP
measurements (for example, due to eyelid squeezing or tremor)
7.

BENEFITS

You can take measurements of your eye pressure at various times during the
day and night with the Icare HOME tonometer. These measurements taken
outside your office visits may help your doctor better understand your eye
pressure, especially if you already have a glaucoma diagnosis.
8.

PACKAGE CONTENTS

The package contains:
• Icare HOME tonometer
• 10 sterilized single-use probes
• 2 batteries
• USB memory stick including the instruction manual
• USB cables
• Support position tags
• Warranty card
• Carrying case
• Wrist strap
• Spare probe base
9.

BEFORE YOU START

Find the main parts, buttons and indicator lights of the tonometer. The figures
are located at the beginning of this document.
FRONT PARTS (Figure 1)
1. Probe base incorporating indicator light
2. Eye recognition transmitter
3. Eye recognition sensor
4. Cheek support
5. Forehead support
Icare HOME Instruction Manual ENGLISH