O9DIRBAlere AirLink for INRatio

Alere AirLink for INRatio2 Fitlinxx 1 Table of Contents 1..................................................................................................................................................................I ntroduction ................................................................................................................................................1 2..................................................................................................................................................................A lere AirLink Description...............................................................................................................................2 3..................................................................................................................................................................I nstallation Instruction.................................................................................................................................3 4..................................................................................................................................................................P erformance Characteristics and Product Specification.................................................................................4 5..................................................................................................................................................................W arranty .......................................................................................................................................................5 6..................................................................................................................................................................W arnings........................................................................................................................................................6 7..................................................................................................................................................................L abel Symbols ..............................................................................................................................................5 8..................................................................................................................................................................C ompliance...................................................................................................................................................6 9..................................................................................................................................................................I ndicators ....................................................................................................................................................6 10................................................................................................................................................................S ervicing ......................................................................................................................................................5 11................................................................................................................................................................C leaning........................................................................................................................................................6 1. Introduction Before You Begin Before using the Alere AirLink device with the Alere INRatio2 meter, read this entire User Guide. Intended Use The Alere AirLink module is designed for use with the home monitoring device the Alere INRatio2 meter. Its main function is to transfer readings from the INRatio2 meter to a server for continuous monitoring of patients with anticoagulation therapy. 2 2. Alere AirLink Description The Alere AirLink is a wireless device that transmits and receives radio frequency signals at very low power with main features as shown in Figure 1. 1. The Alere Airlink is powered by a 3 V Lithium Coin Battery. The battery is placed inside the top plastic cover of the Alere AirLink and secured by a slide in slide out door. 2. The Alere AirLink has two connector plugs to plug into the INRatio2 meter. A serial plug and a power plug. The power plug passes through the Alere AlirLink to the INRatio2 meter; it doesn’t supply the AirLink with any power. The serial plug is powered by the Lithium Coin Battery and doesn’t withdraw any power from the INRatio2 meter. 4. The INRatio2 AC adapter plugs into the DC power jack connector of the Alere Airlink and passes power to the INRatio2 meter through the power plug. Figure 1 Alere AirLink Adapter Battery Serial Plug Power Plug Power Jack 3 3. Installation Instructions 1. Insert the Lithium Coin Battery into the Battery well, and then slide the battery cover in. Figure 2 Figure 2 2. Connect the Alere AirLink to the INRatio2 meter. While inserting the connectors plugs into the INRatio2 meter make sure they go in evenly at the same time. Figure 3 Figure 3 Battery Cover Battery Well Plug in this Direction INRatio2 Meter 4 3. The Alere AirLink should start transmitting and receiving data from the INRatio2 meter and/or any nearby access point. 4. Performance Characteristics and Product Specification Power Rating Single 3V CR2032 lithium ion battery Supply: Input: 100 – 240 VAC Output: 7.5 VDC Use for INRatio Only Operating Conditions ( Environmental Conditions) Temperature: 50-95ºF(10-35ºC) Humidity: 15 – 93 %(without condensation) Atmospheric Pressure: 700 hPa – 1060 hPa Memory Stores up to 120 readings Data Ports RS232 Wireless Data Transfer up to 70 ft Size 7.242 H x 4.227 W x 0.848 D cm Weight 0.1 lb ( 46 g ) with Lithium Coin Battery Packaging The Alere AirLink is inside a plastic bag together with instructions inser…

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Date: 10/20/2011 Federal Communications Commission Office of Engineering and Technology 7435 Oakland Mills Road Colombia, MD 21046 Subject: Confidentiality Request for FCC ID: O9DIRB Dear Sir, We Filtlinxx, Inc respectfully request all the documents submitted with this application for certification under FCC ID: O9DIRB be withheld from public disclosure. This request is made Pursuant to FCC 47 CRF 0.457(d) and 0.459 and IC RSP-100, Section 10, Fitlinxx requests that the entire subject FCC/IC application be held confidential. Type of Confidentiality Requested Exhibit Short Term Permanent Block Diagrams Short Term Permanent Internal Photos Short Term Permanent Operation Description/Theory of Operation Short Term Permanent Schematics Short Term Permanent User’s Manual

TUV Rheinland 336 Initiative Dr., Rochester, NY 14624 FCC ID: O9DIRB Tel: (585) 426-5555, Fax: (585) 568-8338 IC ID: 4068A-IRB Report Number: FORMTEXT |31152711.001 Airlink.pdf Page 1 of 2 EUT: Alere Airlink for INRatio 2 Model: 55119 33_EME/I 01/29/2001 External Photos EUT Name: Alere Airlink for INRatio 2 EUT Model: 55119 FCC ID: O9DIRB , IC ID: 4068A-IRB FCC Title 47, Part 15, SubpartC, RSS-210 Issue 8 Prepared for: John MacLean Fitlinxx 3 Enterprise Dr. Shelton, CT 06848 Tel: 978-357-8086 Fax: 508-357-7990 Prepared by: TUV Rheinland of North America 336 Initiative Dr Rochester, NY 14624 Tel: (585) 426-5555 Fax: (585) 568-8338 http://www.tuv.com/ Report/Issue Date: 7 November 2011 Report Number: 31152711.001 Airlink.pdf TUV Rheinland 336 Initiative Dr., Rochester, NY 14624 FCC ID: O9DIRB Tel: (585) 426-5555, Fax: (585) 568-8338 IC ID: 4068A-IRB Report Number: FORMTEXT |31152711.001 Airlink.pdf Page 2 of 2 EUT: Alere Airlink for INRatio 2 Model: 55119 33_EME/I 01/29/2001 External Photos: Figure 1: External View Figure 2: External View - bottom

Alere AirLink Device Label_US_R410/14/11 PN: 28353 Rev. A 2011/10 IC: 4068A-IRB FCC ID: O9DIRB55119 Manufactured for: Alere San Diego, Inc. San Diego, CA 92121 www.alere.com Made in China AirLink for INRatio ® 2 CR 2032, 3V

Label Location – FCC ID O9DIRB IC 4068A-IRB

TUV Rheinland 336 Initiative Dr., Rochester, NY 14624 FCC ID: O9DIRB Tel: (585) 426-5555, Fax: (585) 568-8338 IC ID: 4068A-IRB Report Number: 31152711.001 Airlink.pdf Page 1 of 2 EUT: Alere Airlink for INRatio 2 Model: 55119 33_EME/I 01/29/2001 Internal Photos EUT Name: Alere Airlink for INRatio 2 EUT Model: 55119 FCC ID: O9DIRB , IC ID: 4068A-IRB FCC Title 47, Part 15, SubpartC, RSS-210 Issue 8 Prepared for: John MacLean Fitlinxx 3 Enterprise Dr. Shelton, CT 06848 Tel: 978-357-8086 Fax: 508-357-7990 Prepared by: TUV Rheinland of North America 336 Initiative Dr Rochester, NY 14624 Tel: (585) 426-5555 Fax: (585) 568-8338 http://www.tuv.com/ Report/Issue Date: 7 November 2011 Report Number: 31152711.001 Airlink.pdf TUV Rheinland 336 Initiative Dr., Rochester, NY 14624 FCC ID: O9DIRB Tel: (585) 426-5555, Fax: (585) 568-8338 IC ID: 4068A-IRB Report Number: 31152711.001 Airlink.pdf Page 2 of 2 EUT: Alere Airlink for INRatio 2 Model: 55119 33_EME/I 01/29/2001 Internal Photos: Figure 1: Internal View Antenna Figure 2: Internal View – Back of cover

FCCID: O9DIRB IC: 4068A-IRB Report No.: 31152711.001 Airlink.doc Page 1 of 32 The test results contained in this report refer exclusively to the product(s) presented for testing. No liability may be assumed for models or products not referred to herein. This test report may not be published or duplicated in part without permission of the testing body. This test report by itself does not constitute authorization for the use of any TUV Rheinland test mark. The report must not be used by the client to claim product certification, approval, or endorsement by NVLAP, NIST, or any agency of the Federal Government. TUV Rheinland of North America, Inc., 762 Park Avenue, Youngsville, NC 27596-9470, Tel: 919-554-3668, Fax: 919-554-3542 QF09B040 Revision 0 Electromagnetic Compatibility Test Report Prepared in accordance with FCC Part 15C, RSS-210 Issue 8 and ANSI C63.10 On Alere Airlink for INRatio2 55119 Fitlinxx 3 Enterprise Dr Shelton, CT 06848 Prepared by: TUV Rheinland of North America, Inc. FCCID: O9DIRB IC: 4068A-IRB Report No.: 31152711.001 Airlink.doc Page 3 of 32 The test results contained in this report refer exclusively to the product(s) presented for testing. No liability may be assumed for models or products not referred to herein. This test report may not be published or duplicated in part without permission of the testing body. This test report by itself does not constitute authorization for the use of any TUV Rheinland test mark. The report must not be used by the client to claim product certification, approval, or endorsement by NVLAP, NIST, or any agency of the Federal Government. TUV Rheinland of North America, Inc., 762 Park Avenue, Youngsville, NC 27596-9470, Tel: 919-554-3668, Fax: 919-554-3542 QF09B040 Revision 0 Identification: Alere Airlink for INRatio2 Serial No.: NFFJ-00256-00166 Test item: 55119 Date Test Completed: 10/18/2011 Testing location: TUV Rheinland of North America 336 Initiative Drive Rochester, NY 14624-6217 U.S.A. Tel: (585) 426-5555 Fax: 585-568-8338 Test specification: Emissions: RSS-210 Issue 8Radiated Emissions Std FCC Parts 15.249(d), 15.209, 15.215(c) and RSS-210 A2.9, RSS-GEN 7.2.1, Conducted Emissions Std FCC Part 15.249 and RSS-210 Annex 2.9, Immunity: FCC Part 15, Subpart C, FCC Parts 15.249(a), 15.249(c), RSS-210 A2.9(a), FCC Part 15.109(a) and RSS-210 2.2 and 2.3, Test Result: The above product was found to be Compliant to the above test standard(s) tested by: Randall Masline reviewed by: Cecil Gittens 2 November 2011 Date Name Signature 2 November 2011 Date Name Signature Other Aspects: None Abbreviations: OK, Pass, Compliant, Complies = passed Fail, Not Compliant, Does Not Comply = failed N/A = not applicable Industry Canada BSMI US5253 NVLAP CODE 200313-0 3466C-1 SL2-IN-E-050R FCCID: O9DIRB IC: 4068A-IRB Report No.: 31152711.001 Airlink.doc Page 4 of 32 The test results contained in this report refer exclusively to the product(s) presented for testing. No liability may be assumed for models or products not referred to herein. This test report may not be published or duplicated in part without permission of the testing body. This test report by itself does not constitute authorization for the use of any TUV Rheinland test mark. The report must not be used by the client to claim product certification, approval, or endorsement by NVLAP, NIST, or any agency of the Federal Government. TUV Rheinland of North America, Inc., 762 Park Avenue, Youngsville, NC 27596-9470, Tel: 919-554-3668, Fax: 919-554-3542 QF09B040 Revision 0 TABLE OF CONTENTS 1 GENERAL INFORMATION ......................................................................................................................... 5 1.1 SCOPE......................................................................................................................................................... 5 1.2 PURPOSE..................................................................................................................................................... 5 1.3 SUMMARY OF TEST RESULTS..................................................................................................................... 6 2 LABORATORY INFORMATION ................................................................................................................ 7 2.1 ACCREDITATIONS & ENDORSEMENTS........................................................................................................ 7 2.2 MEASUREMENT UNCERTAINTY EMISSIONS............................................................................................... 8 2.3 CALIBRATION TRACEABILITY.................................................................................................................... 8 2.4 MEASUREMENT EQUIPMENT USED............................................................................................................ 9 3 PRODUCT INFORMATION ....................................................................................................................... 10 3.1 EQUIPMENT MODIFICATIONS................................................................................................................... 10 3.2 TEST PLAN................................................................................................................................................ 10 4 RADIATED EMISSIONS IN TRANSMIT MODE .................................................................................... 11 4.1 RADIATED EMISSIONS - FCC PARTS 15.249, RSS-210 A2.9(A) ............................................................... 11 4.2 BAND EDGE REQUIREMENTS - FCC PART 15.249(D), RSS-210 2.2 ......................................................... 20 4.1 CONDUCTED EMISSIONS ON AC MAINS – FCC 207(A) AND RSS-GEN 7.2.4.......................................... 23 4.2 99% POWER BANDWIDTH – RSS-210 A1.1.3........................................................................................... 24 4.3 EXTREME VOLTAGE REQUIREMENTS - FCC PART 15.249(B)(2) ..…

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TUV Rheinland 336 Initiative Dr., Rochester, NY 14624 FCC ID: O9DIRB Tel: (585) 426-5555, Fax: (585) 568-8338 IC ID: 4068A-IRB Report Number: 31152711.001 Airlink.pdf Page 1 of 3 EUT: Alere Airlink for INRatio 2 Model: 55119 33_EME/I 01/29/2001 Test Setup Photos EUT Name: Alere Airlink for INRatio 2 EUT Model: 55119 FCC ID: O9DIRB , IC ID: 4068A-IRB FCC Title 47, Part 15, SubpartC, RSS-210 Issue 8 Prepared for: John MacLean Fitlinxx 3 Enterprise Dr. Shelton, CT 06848 Tel: 978-357-8086 Fax: 508-357-7990 Prepared by: TUV Rheinland of North America 336 Initiative Dr Rochester, NY 14624 Tel: (585) 426-5555 Fax: (585) 568-8338 http://www.tuv.com/ Report/Issue Date: 7 November 2011 Report Number: 31152711.001 Airlink.pdf TUV Rheinland 336 Initiative Dr., Rochester, NY 14624 FCC ID: O9DIRB Tel: (585) 426-5555, Fax: (585) 568-8338 IC ID: 4068A-IRB Report Number: 31152711.001 Airlink.pdf Page 2 of 3 EUT: Alere Airlink for INRatio 2 Model: 55119 33_EME/I 01/29/2001 Test Setup Photos: Figure 1: Figure 2: TUV Rheinland 336 Initiative Dr., Rochester, NY 14624 FCC ID: O9DIRB Tel: (585) 426-5555, Fax: (585) 568-8338 IC ID: 4068A-IRB Report Number: 31152711.001 Airlink.pdf Page 3 of 3 EUT: Alere Airlink for INRatio 2 Model: 55119 33_EME/I 01/29/2001 Figure 3: Figure 4: