Indications For Use; Contraindications; Warning - Icare Home Instruction Manual

Icare HOME tonometer Instruction manual for health care professionals

WARNING!

Use of this equipment adjacent to or stacked with other equipment should be
avoided because it could result in improper operation. If such use is necessary,
this equipment and the other equipment should be observed to verify that they are
operating normally.
PRECAUTION!
• When you have opened the package, check for any external damage or faults,
particularly for damage to the case. If you suspect that there is something wrong
with the tonometer, contact the dealer who sold the tonometer to you.
• Use the tonometer only for measuring intraocular pressure. Any other use
is improper and the manufacturer is not liable for any damage arising from
improper use, or for the consequences of such use.
• Never open the casing of the tonometer, except for the battery compartment.
• Never allow the tonometer to get wet.
• Do not use the tonometer near flammable substances, including flammable
anesthetic agents.
• Certain microbiological agents (for example, bacteria) can be transmitted from
the forehead or cheek support. To prevent this, clean the forehead and cheek
support for each new patient with disinfectant. See the chapter 'Cleaning and
disinfection'.
• The tonometer conforms to EMC requirements (IEC 60601-1-2), but interference
may occur within the tonometer if used near (<1m) a device causing high
intensity electromagnetic emissions, such as a cellular phone. Although the
tonometer's own electromagnetic emissions are well below the levels permitted
by the relevant standards, they may cause interference in other, nearby devices,
for example sensitive sensors.
• If you do not use the tonometer for a long time, remove the batteries, as they
may leak.
• Be sure to dispose of the single-use probes properly (for example, in a bin for
metal waste).
• Batteries, packaging materials and probe bases must be disposed of according
to local regulations.
• Make sure you use batteries with built-in PTC protection, for example Energizer
Lithium Photo 123 3V CR123A.
• Do not cover the eye recognition transmitters or sensor during the
measurement, for example with your fingers. Keep your hand, hair etc. and
objects such as pillows away from the temple side of your eye, as they produce
an infrared reflection that causes an error.
• The tonometer turns off automatically after 3 minutes if you do not use it.
• Update the tonometer's time to your local time. It is done automatically by
performing the steps 1 and 2 under section 11. Reading the measurement data.
2.

INDICATIONS FOR USE

The Icare HOME tonometer is a prescription device intended for monitoring of
intraocular pressure (IOP) of the human eye. It is indicated for use by patients
or their caregivers under supervision of an eye care professional.
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. Disabling arthritis or limited motor coordination affecting self-handling
of the Icare tonometer
4. Blepharospasm
5. 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
2