Icare Icare HOME TA022, Инструкция по эксплуатации

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Icare HOME Icare HOME
3. The HCP loads the probe:
• Unwraps the probe.
• Removes the lid of the probe container.
• Drops the probe into the probe base without touching the probe by
holding the probe container.
• Presses the measurement (play) button briefly (1 second) to activate
the probe.
4. Explain and show illustrations for how to position the tonometer (use a
separate illustration sheet from the labeling for this):
• Sit or stand in front of a mirror and hold the tonometer sideways in
front of your face.
• Align probe tip with center of cornea and rotate the tonometer until
probe tip points straight at cornea.
• Make sure probe base light is green. If probe base light is red, make
sure you are facing straight ahead (i.e. head held at a 90° angle) and
tilt tonometer until probe base light turns green.
• The probe base light does not turn red in response to horizontal
deviations as illustrated in the figure on the right. For this reason make
sure the probe is centered in sight to ensure the probe contacts the
center of cornea during measurement even if the probe base light is
green. If the probe is not centered in your sight, repeat steps 5 and 6.
This is very important because the tonometer with the probe must not
be tilted more than 10 degrees away from the center of the cornea
and without visualizing the probe base light it is difficult to judge the
horizontal angle of the device.
5. Explain how to take the measurement:
• Explain that the Measure light will flash when the tonometer is ready
to measure.
• Explain that the user must take six individual measurements for the
IOP result and that the results are stored in the tonometer.
• Explain to the patient that the measurement button must be
depressed to obtain the sequence of 6 measurements until a long
beep is heard and the green “Done” light is illuminated on the back
panel. The probe base light turns off at the same time.
STEP 2 – Demonstrate measurements from your (HCP’s) own eye
1. Position the tonometer on your (HCP) own eye as instructed above.
2. Ask the patient to observe and learn.
STEP 3 – Supervised patient use of the icare home
1. Load a new probe and carefully, without touching the patient’s eye, choose the eye
and set the distance between the tip of the probe and the center of the cornea for
the patient at 4-8mm (5/32-5/16”) by turning knobs to adjust forehead and cheek
support positioning as needed. Write the settings down on a support position tag for
the patient.
2. Ask the patient to position the tonometer on the chosen eye and take some self-
measurements as instructed and demonstrated.
3. Observe and, if necessary, correct the position while the patient positions the
tonometer, say to the patient that this is the correct position and ask the patient to
try again.
4. Repeat 1-3 for up to 10 times until the patient shows consistent device positioning.
If the patient cannot consistently measure after this point the patient will be
considered to be unable to measure the IOP using the HOME device.
STEP 4 – Self-measurement by the patient
1. Load a new probe and ask the patient to measure his/her IOP three times with
the same Icare HOME tonometer.
2. Observe if the positioning is correct. Do not supervise or interact.
STEP 5 – Measurement of patient’s IOP by HCP
3. The HCP measures the IOP of the patient once with the GAT tonometer.
STEP 6 – Certification
Connect device to computer and view the readings in the Icare LINK software.
The patient passes the training and is certified for self-use if the following conditions
are met:
a. The first of the three HOME readings taken by the patient and the GAT
result measured by the HCP differ by 5 mmHg or less.
b. The range (max-min) of the three readings taken by the patient is 7 mmHg
or less.
c. The positioning of the tonometer was correct during self-use as
determined by the HCP.
Patient ID: Date (dd mm yy):
CERTIFICATION 0 = Pass; 1 = Fail EYE 0 = Right; 1 = Left, 2 = Both
Icare HOME tonometer Instruction manual for health care professionals Icare HOME tonometer Instruction manual for health care professionals English English