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 CONTENTS
I-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.: +423 663 169205
Fax: +44 1923 859 810
E-mail: [email protected]
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.