Icare tonometer ONE manual
English
3
www.icaretonometer.com
WARNING!
Health care professionals must inform patients not to modify or discontinue their treatment plan without receiving instructions from the health care
professional.
WARNING!
Do not change your medication or dosage without consulting your doctor.
WARNING!
IOP accuracy and repeatability are unknown for patients with corneal astigmatism > 3.00 D of astigmatism, irregular astigmatism and keratoconus.
WARNING!
Patients with hearing loss may not detect signals that indicating correct measurements.
WARNING!
Patients with physical challenges may experience difficulty in using the hand-held tonometer.
WARNING!
No modification of this equipment is allowed
CAUTION!
Before using the tonometer read this manual carefully. Keep it for future use. It contains important information on using and servicing the
tonometer.
CAUTION!
Federal (US) law restricts this device to sale by or on the order of a physician or properly licensed practitioner.
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.
Use the tonometer only for measuring intraocular pressure. Any other use is improper and the manufacturer cannot be held liable
for any damage arising from improper use, or for the consequences thereof.
Never open the casing of the tonometer, except for the battery compartment or to change the probe base.
Never use the tonometer in wet or damp conditions nor allow the tonometer to get wet.
The probe base, battery compartment cover, screws, collar and probes are so small that a child could swallow them. Keep the
tonometer out of the reach of children.
Do not use the device near inflammable substances, including flammable anesthetic agents.
Certain microbiological agents (for example, bacteria) can be transmitted from the forehead, eye or cheek support. To avoid this,
the forehead and cheek support and eye piece must be cleaned for each new patient with disinfectant, for example an alcohol
solution.
The tonometer conforms to EMC requirements (IEC 60601-1-2), but interference may occur in it if used near (<1m) a device (such as
a cellular phone) causing high-intensity electromagnetic emissions. 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 the device is not to be used for a long time, remove its batteries, as they may leak. Removing the batteries restores the device to
normal measurement mode.
For every patient to be measured take a new probe to avoid cross contamination of bacteria or viruses and infection of the eye
Use probes taken only from original intact packaging. Sterility of the probe cannot be guaranteed once the seal is compromised.
The tonometer probes are labeled single-use only. Re-sterilization or re-use of the probe can result in incorrect measurement or
damage to the probe head.
Be sure to dispose of the single-use probes properly (for example, in a container for disposable needles). Probes may become
contaminated with micro-organisms after one-time use.
Do not connect the USB cable during measurements. When connected it is impossible to perform measurement.
Do not change the batteries or probe base when the USB-cable is connected.
Batteries, packaging materials and probe bases must be disposed of according to local regulations. Use only original probes (see
Figure 5) and accessories.
INDICATIONS FOR USE
Icare ONE tonometer (TA02) is indicated for the monitoring of intraocular pressure (IOP) of the human eye. It is intended to be used by health care
professionals and by patients under supervision and control of the health care professional. Patient use is by prescription only.