6
7
10
11
Push the Ejector button and the Single-Use-Sensor
will be ejected.
You may now discard the
Single-Use-Sensor.
The LCD will display a test result.
See the next Section for a discussion of how to
interpret the measurement results.
4.6. EJECT THE SINGLE-USE-SENSOR
5. EXPECTED RESULTS
I-PEN
®
test results are displayed on the LCD in units of mOsms/L. No calculations are required. The
chart below shows some typical test results and their possible interpretation. All such interpretations are
subject to the review of the physician or other medical professional.
I-PEN
®
User Guide
|
PERFORMING AN OSMOLARITY MEASUREMENT
I-PEN
®
User Guide
|
EXPECTED RESULTS
1.
Do not immerse the tip of the Single-Use-Sensor in the lower tear meniscus.
2. If the reading on the LCD screen shows an “Error”, you may attempt another reading in the same eye by
pressing the Ready button.
4.5.1. TIPS FOR USE
4. Approach at a 30-45 degree angle from horizontal and gently lower the end of the Single-Use-
Sensor on to the conjunctiva on the inside of the lower eyelid.
5. When correctly placed, the tip of the Single-Use-Sensor should be depressing the surface slightly
so that both gold nodes are in good contact with the conjunctiva.
6. The I-PEN
®
will take make an audible beep after several seconds and display the reading
on the LCD screen.
4.5. TAKING A READING
1. Ask the patient to gently squeeze their eyelids shut
for 30-60 seconds prior to taking a reading.
2. Position the tip of the disposable Single-Use-Sensor
just above the lower eyelid with the LCD screen
facing upwards.
3. Turn on the I-PEN
®
as indicated in section 4.4
only
when you are ready to take the reading
by pushing
the on/off switch to the on position.
4.4. TURN ON THE DEVICE
Push the On/Off switch
6
. You should hear a
“beep” and the LCD display
7
should display
the “I-PEN Ready” message.
CAUTION:
Replace the device if a “beep” is not heard after turning it on.
NOTE:
In order to conserve battery life, the I-PEN
®
is programmed to enter Sleep Mode
automatically thirty seconds after it powers up. In doing so, this can invalidate the SUS and
a new SUS should be inserted.
CAUTION:
Do not use the unit if the Reader does not display “I-PEN Ready”.
DRY EYE SEVERITY SCALE
380
365
350
335
320
305
290
275
Normal
< 290
Marginal
290-310
Mild
310-330
Moderate
330-350
Severe
> 350
5.1. REFERENCE TEAR OSMOLARITY VALUES
Reading in mOsms/L
(Use result from eye with
highest reading)
Variance Between Right &
Left Eye
Interpretation
<290
Normal Patient
290-310
≤7
Normal Patient
290-310
≥8
Dry Eye Disease Patient
>310
Dry Eye Disease Patient