FitLinxx IRB Alere AirLink for INRatio User Manual User s Guide V 1 2

FitLinxx Alere AirLink for INRatio User s Guide V 1 2

User's Guide, V 1.2

AlereAirLinkforINRatio2Fitlinxx
1TableofContents1. .................................................................................................................................................................Introduction ................................................................................................................................................12. .................................................................................................................................................................AlereAirLinkDescription...............................................................................................................................23. .................................................................................................................................................................InstallationInstruction.................................................................................................................................34. .................................................................................................................................................................PerformanceCharacteristicsandProductSpecification.................................................................................45. .................................................................................................................................................................Warranty .......................................................................................................................................................56. .................................................................................................................................................................Warnings........................................................................................................................................................67. .................................................................................................................................................................LabelSymbols ..............................................................................................................................................58. .................................................................................................................................................................Compliance...................................................................................................................................................69. .................................................................................................................................................................Indicators ....................................................................................................................................................610. ...............................................................................................................................................................Servicing......................................................................................................................................................511. ...............................................................................................................................................................Cleaning........................................................................................................................................................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WellPlug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 insert to the user. The plastic bag is placed in a pink bubble wrap bag Store at -20 ºC to 70 ºC ( -4 F to 158 F )
5 5. Warranty Limited One Year Warranty 6. Warnings Failure to comply with the operating manual when installing the Alere AirLink with the INRatio2 meter could lead to damaging the device plugs. Unplug the AC power adapter from the power outlet when you are not using it to power the INRatio2 meter Remove battery from the Alere Airlink Adapter if the unit is not in use for long periods of time 7. Label Symbols Attention:ConsultAccompanyingDocuments
68. Compliance Safety Statement • This device has been tested and found to comply with the requirements of IEC 60601 EMC Statement • This device complies with Part 15 FCC Rules. Operation is subject to the following conditions: (1) this device may not cause harmful interference and (2) this device must accept any interference received, including interference that may cause undesired operation. • This device complies with Industry Canada licence-exempt RSS standard(s). Operation is subject to the following two conditions: (1) This device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device. Conformément à la réglementation d'Industrie Canada, le présent émetteur radio peut fonctionner avec une antenne d'un type et d'un gain maximal (ou inférieur) approuvé pour l'émetteur par Industrie Canada • Le présent appareil est conforme aux CNR d'Industrie Canada applicables aux appareils radio exempts de licence. L'exploitation est autorisée aux deux conditions suivantes :
7(1) l'appareil ne doit pas produire de brouillage, et (2) l'utilisateur de l'appareil doit accepter tout brouillage radioélectrique subi, même si le brouillage est susceptible d'en compromettre d. WEEE Statement • The WEEE directive is intended to prevent waste consisting of electrical and electronic equipment from being introduced to the waste stream, and places the responsibility for disposal, and or recycling, of WEEE on its producer. The WEEE directive also defines 10 product categories for differentiating electrical and electronic equipment covered by it and the RoHS directive. As of the directive’s effective date of August 13, 2005, all our applicable products are labeled with the WEEE-approved recycle bin marking (see below) 9. Indicators LED Indicator The RED LED indicator provides a low battery alert to the user Audible Indicator The Buzzer provides an audio indication of a low battery alert to the user Note: The Alere AirLink Adapter battery is non-rechargeable. Please replace battery if the LED flashes and the Buzzer beeps. 10.Servicing • Follow the directions for battery replacement indicated in the installation instructions • Dispose the battery in compliance with local regulations
8 11. Cleaning Follow the steps to keep the device clean: Note: No maintenance is required other than routine cleaning Clean the outside of the device with a clean damp cloth. If necessary, a mild detergent or disinfectant ( such as a 5% bleach solution or 70% isopropyl alcohol) may be used.

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