I-MED I-PEN User Manual

FOR QUANTITATIVE MEASUREMENT

OF OSMOLARITY OF OCULAR TISSUES

Osmolarity System

USER MANUAL

osdcare.com

2 3

1. ABOUT THIS MANUAL 4

1.1. Warnings and Precautions 4

2. ESSENTIAL PRESCRIBING INFORMATION 5

2.1. Device Description 5

2.2. Intended Use 5

2.3. Indications 5

2.4. Contraindications 5

2.5. General Safety Instructions 6

3. DESCRIPTION OF COMPONENTS 7

3.1. Identifying System Components 7

3.2. I-PEN® Osmolarity System 7

3.3. I-PEN® Osmolarity Test Sensor 7

4. PERFORMING AN OSMOLARITY MEASUREMENT 8

4.1. Prepare the I-PEN® for Use 8

4.1.1. Insert the Battery 8

4.2. Remove the Single-Use-Sensor from Package 9

4.3. Insert the Single-Use-Sensor 9

4.4. Turn on the Device 10

4.5. Taking a Reading 10

4.5.1. Tips for Use 10

4.6. Eject the Single-Use-Sensor 11

5. EXPECTED RESULTS 11

5.1. Reference Tear Osmolarity Values 11

6. CLEANING AND MAINTENANCE 12

6.1. Cleaning 12

6.1.1. I-PEN® Device 12

6.1.2. Single-Use-Sensors 12

6.2. Maintenance 12

6.2.1. Troubleshooting 12

7. OPERATING AND STORAGE CONDITIONS 13

8. TECHNICAL SPECIFICATIONS 13

9. ELECTROMAGNETIC EMISSIONS 14

10. ELECTROMAGNETIC IMMUNITY 15

10.1. Recommended Separation Distances 17

10.1.1. Applicable Standards 17

11. LABELS AND SYMBOLS 18

11.1. Labels 18

11.2. Symbols 18

I-PEN® User Guide | TABLE OF CONTENTSI-PEN® User Guide

I-PEN

®

I-PEN® is a trademark of I-MED Pharma Inc. Other registered trademark
or trademarks are the property of their respective owners.

CONTACT INFORMATION

Customer satisfaction is an I-MED Pharma Inc. priority.
To help us in providing you with the best possible product and support,
please send us your comments and suggestions.

I-MED Pharma Inc.
1601 St-Regis Blvd.
Dollard-des-Ormeaux, QC
Canada H9B 3H7

Authorized Representative in the EU:

Medes Ltd.

5 Beaumont Gate, Shenley Hill, Radlett
Herts WD7 7AR United Kingdom

Tel.: [phone]
Fax: [phone]
E-mail: [e-mail]

www.medeseurope.com

Marking by the CE symbol indicates compliance of this device as a
Class 1 medical device with a measuring function, with the Medical
Device Directives 93/42/ EEC as amended by 2007/47/CE.

4 5

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 clarication.

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 lm (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 uid 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 simplies 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 lm 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

6 7

3.1. IDENTIFYING SYSTEM COMPONENTS

3.2. I-PEN® OSMOLARITY SYSTEM

3.3. I-PEN® OSMOLARITY TEST SENSOR

The gures 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 modications 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

qualied 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 qualied 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