2.3. Indications 2.4. Contraindications 2.5. General Safety Instructions I-PEN ® is a trademark of I-MED Pharma Inc. Other registered trademark 3. DESCRIPTION OF COMPONENTS or trademarks are the property of their respective owners. 3.1. Identifying System Components 3.2. I-PEN Osmolarity System ®...
Such problems include device malfunctions, device failure, damage to the device tissue of the lower eyelid. or damage to other property. After several seconds of contact with the eyelid tissue, the I-PEN ® will display a quantitative tear A NOTE provides other important information.
® 3. DESCRIPTION OF COMPONENTS 2.5. GENERAL SAFETY INSTRUCTIONS WARNING: Changes or modifications not expressly approved by I-MED Pharma Inc. can affect 3.1. IDENTIFYING SYSTEM COMPONENTS the safety and effectiveness of the system and will void the system’s warranty. The figures which follow illustrate the components of the I-PEN System.
2. Grasping the bottom firmly with one hand , with the other hand tear in the direction of the pre-cut section to expose the end of the Single-Use-Sensor to be inserted into the I-PEN device . ® WARNING: Do not test patients within 10 minutes after removal of eye makeup.
See the next Section for a discussion of how to a new SUS should be inserted. interpret the measurement results. CAUTION: Do not use the unit if the Reader does not display “I-PEN Ready”. 4.5. TAKING A READING 5. EXPECTED RESULTS 1.
6.2. MAINTENANCE The I-PEN Osmolarity System is designed to work without direct service or preventive maintenance. ® If quality checks fail, contact I-PEN Customer Support. ® 8. TECHNICAL SPECIFICATIONS Battery should be replaced when “Low Bat” indication appears on the screen.
The I-PEN is intended for use in the electromagnetic environment specified below. The customer or the ® user of the I-PEN device should assure that it is used in such an environment. ® It must be installed and prepared for use as described in Section 4. Performing an Osmolarity •...
RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the I-PEN is used exceeds the applicable RF compliance level above, the I-PEN should be observed ®...
2 Zipori Street Tiberias 1424602 mm-yyyy Israel PRT-14-200 Rev. 01 11.2. SYMBOLS A number of internationally recognized symbols are found on the I-PEN unit. ® These relate to safety requirements and standards and are briefly reviewed below. Symbol Symbol meaning...
Page 11
I-MED Pharma Inc. 1601 St-Regis Blvd. Dollard-des-Ormeaux, QC Canada H9B 3H7 Tel: (514) 685-8118 Toll free: (800) 463-1008 Fax: (514) 685-8998 info@imedpharma.com SEE THE DIFFERENCE Product #IPUMEN 0718...