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This manual provides the information necessary to operate the I-PEN
®
system in a safe and efficient
manner. Please read and thoroughly understand this manual before operating the system. If any part of
this manual is not clear, contact customer support for clarification.
Three types of special messages appear in this User Manual:
A
WARNING
indicates the possibility of injury, death or other serious adverse reactions
associated with the use or misuse of the device.
A
CAUTION
indicates the possibility of a problem with the device associated with its use
or misuse. Such problems include device malfunctions, device failure, damage to the device
or damage to other property.
A
NOTE
provides other important information.
1.1. WARNINGS AND PRECAUTIONS
1. ABOUT THIS MANUAL
2.1. DEVICE DESCRIPTION
2. ESSENTIAL PRESCRIBING INFORMATION
The I-PEN
®
Osmolarity System is a diagnostic testing device for the quantitative measurement of
osmolarity (concentration of dissolved, active particles in solution) of ocular tissues in normal and Dry
Eye Disease patients. The I-PEN
®
is for professional in vivo diagnostic use only.
When either the quantity or quality of secreted tears is compromised (known as aqueous deficient or
evaporative Dry Eye Disease), increased rates of evaporation lead to a concentrated tear film (increased
osmolarity) that places stress on the corneal epithelium and conjunctiva.
The I-PEN
®
Osmolarity Single-Use-Sensor, in conjunction with the I-PEN
®
Osmolarity System, provides
a quick and simple method for determining tear osmolarity using impedance measurements of the
saline concentration of the extracellular fluid contained in the eyelid tissue. To perform a test, attach a
new Single-Use-Sensor onto the System Reader and touch the tip of the Single-Use-Sensor to the inner
tissue of the lower eyelid.
After several seconds of contact with the eyelid tissue, the I-PEN
®
will display a quantitative tear
osmolarity test result on the liquid crystal display (LCD). The I-PEN
®
Osmolarity System simplifies the
osmolarity determination process by eliminating the need to transfer tear fluid samples and reducing
the risk of evaporation.
The I-PEN
®
Osmolarity Test utilizes an impedance measurement to provide an assessment of osmolarity
of the conjunctival tissues surrounding the eye.
2.2. INTENDED USE
The I-PEN
®
Osmolarity System is a device for the quantitative measurement of osmolarity
(concentration of dissolved, active particles in tissue immersed in solution) of human tears in normal
and Dry Eye Disease patients.
The I-PEN
®
Osmolarity System should be used only by a trained clinician or under the supervision of
a trained clinician.
2.3. INDICATIONS
The I-PEN
®
Osmolarity Device is indicated for use in the diagnosis of certain ocular surface disorders
which affect the osmolarity of the tear film on the surface of the eye.
2.4. CONTRAINDICATIONS
There are no contraindications known at this time.
I-PEN
®
User Guide
|
ABOUT THIS MANUAL
I-PEN
®
User Guide
|
ESSENTIAL PRESCRIBING INFORMATION