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3.1. IDENTIFYING SYSTEM COMPONENTS
3.2. I-PEN
®
OSMOLARITY SYSTEM
3.3. I-PEN
®
OSMOLARITY TEST SENSOR
The figures which follow illustrate the components of the I-PEN
®
System.
The I-PEN
®
is a portable hand held battery- operated unit that calculates and displays the osmolarity test
result. The unit includes a small display screen that shows the osmolarity test result.
Each Single-Use-Sensor is a single- use, individually packaged unit, designed to work in conjunction with
the I-PEN
®
. The Single-Use-Sensor does not contain chemicals or reagents.
Unit cover
Ready button
On/Off
switch
WARNING:
Do not use a Single-Use-Sensor that is physically damaged.
CAUTION:
Do not use the Single-Use-Sensors past the expiration date.
CAUTION:
Single-Use-Sensors are for single use only.
2.5. GENERAL SAFETY INSTRUCTIONS
3. DESCRIPTION OF COMPONENTS
WARNING:
Changes or modifications not expressly approved by I-MED Pharma Inc. can affect
the safety and effectiveness of the system and will void the system’s warranty.
WARNING:
Use only indoors, in a clean, dry environment.
WARNING:
Do not use a Single-Use-Sensor that is physically damaged.
WARNING:
The system contains no user-serviceable components.
WARNING:
Medical device regulations restrict the operation of the application to trained and
qualified personnel.
WARNING:
Do not test patients who have used eye drops within two hours prior to testing.
WARNING:
Do not test patients wearing makeup on eyelids.
WARNING:
Do not test patients within 10 minutes after removal of eye makeup.
WARNING:
Do not test patients after ocular surface staining.
WARNING:
Do not test patients after invasive ocular diagnostic testing.
WARNING:
Do not test patients within 10 minutes after a slit lamp examination.
WARNING:
Do not test a patient who has been crying.
CAUTION:
The information contained in this Manual is intended for the sole and exclusive use of
the Company’s customers. Any other unauthorized use of this Manual or any of the information
it contains is prohibited.
CAUTION:
Refer all service problems to a qualified I-MED Pharma Inc. representative only.
CAUTION:
Replace the device if the LCD is cracked, unreadable, has missing pixels, or is
otherwise damaged.
CAUTION:
Replace the device if a “beep” is not heard after turning it on.
CAUTION:
Check the operation of the device prior to use. Replace if damaged.
CAUTION:
Replace the device if the casing or battery cover is lost or damaged.
CAUTION:
Single-Use-Sensors are for single use only.
CAUTION:
Do not use the Single-Use-Sensors past the expiration date.
CAUTION:
The device is to be used within a clinical facility environment only.
CAUTION:
The device is for professional in vivo diagnostic use only.
LCD display
Battery
cover
I-PEN
®
User Guide
|
GENERAL SAFETY INSTRUCTIONS
I-PEN
®
User Guide
|
DESCRIPTION OF COMPONENTS