Alere Afinion ™ as100 Analyzer us
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- Bu səhifədəki naviqasiya:
- Notes
- Conformity to the European IVD directive
- TABLE OF CONTENTS Table of contents
| 1 Dear Customer, Congratulations on the purchase of your Alere Afinion™ AS100 Analyzer. Upon arrival of your Alere Afinion™ AS100 Analyzer we recommend that the serial number along with the software version be recorded in the table provided below. The additional rows in the table are to be utilized if a software upgrade is performed on your AS100 Analyzer. The recorded information will be of great value if and when a question is reported, or the desire to add a new Alere Afinion™ test to your Analyzer arises. Serial number (see label on the underside of the Analyzer or on the transport container) NOTE! The Analyzer must be turned off when the label on the underside is read.
Date Software version* Alere Afinion™ tests available Upon receipt 1. SW upgrade 2. SW upgrade 3. SW upgrade 4. SW upgrade 5. SW upgrade * See start-up menu when you power on the Analyzer (see “How to power on the Analyzer”, page 10). Notes
Technical Support Call 1.866.216.9505 2 Alere Afinion TM AS100 Analyzer System Intended use Alere Afinion™ AS100 Analyzer with Alere Afinion™ Data Connectivity Converter (ADCC) is a compact multi-assay analyzer for point-of-care testing, designed to analyze the Alere Afinion™ Test Cartridges. The ADCC is a small device for automatic transfer of data, including patient and control assay results, from the Alere Afinion™ Analyzer to a laboratory information system or another electronic journal system. Alere Afinion™ AS100 Analyzer System, consisting of Alere Afinion™ AS100 Analyzer with Alere Afinion™ Data Connectivity Converter (ADCC), Alere Afinion™ Test Cartridges and Alere Afinion™ Controls is for in vitro diagnostic use only. CLIA Statements Waived Alere Afinion™ tests Alere Afinion™ HbA1c is waived under the Clinical Laboratory Improvement Amendment of 1988 (CLIA`88). A CLIA Certificate of Waiver is needed to perform testing in a waived setting. If the laboratory does not have a Certificate of Waiver, the Application for Certification (Form CMS-116), can be obtained at https://www.cms.gov/cmsforms/downloads/cms116.pdf. The form should be mailed to the address of the local State Agency of the State in which the laboratory resides (https://www.cms.gov/CLIA/12_State_Agency_&_Regional_Office_CLIA_Contacts.asp). If the laboratory modifies the Alere Afinion™ test or Alere Afinion™ AS100 Analyzer system instructions, the test no longer meets the requirements for waived categorization. A modified test is considered to be highly complex and is subject to all applicable CLIA requirements.
The Alere Afinion™ AS100 Analyzer meets all provisions in the European directive 98/79/EC on In Vitro Diagnostic Medical Devices and is CE marked accordingly.
Alere Afinion™ AS100 Analyzer has been tested and found to be in conformity with IEC, UL, CAN/CSA-C22.2: 61010-1 (Safety requirements for electrical equipment for measurement, control, and laboratory use), IEC 61010-2-081:2001 + A1 and IEC 61010-2-101:2002 (Particular requirements for in vitro diagnostic (IVD) medical equipment).
Alere Afinion™ AS100 Analyzer has been tested and found to be in conformity with EN 61326-1:2006 (Electrical equipment for measurement, control, and laboratory use – EMC requirements) and EN 61326-2-6:2006 (In vitro diagnostic (IVD) medical equipment) and CFR 47 Telecommunications, Chapter I- FCC Part 15 – Radio Frequency Devices – Subpart B: unintentional radiators. Alere Technologies AS Kjelsåsveien 161 P.O. Box 6863 Rodeløkka NO-0504 Oslo, Norway www.alere.com ISO 9001 and ISO 13485 certified company
3 TABLE OF CONTENTS Table of contents INTRODUCTION About this User Manual 5 Examining the package contents 5 ANALYZER SYSTEM DESCRIPTION Description of the Alere Afinion™ AS100 Analyzer 6 Description of the Alere Afinion™ Test Cartridge 7 How the Alere Afinion™ AS100 Analyzer System works 8 Internal process control 8 8 The fail-safe mechanisms 8 External process control 8 Patients ID 8 Operator ID 8 Quality Control lockout 8 Calibration 8 GETTING STARTED Installing your Analyzer 9 Connecting power supply 9 Connecting additional equipment 9 How to power ON the Analyzer 10 How to power OFF the Analyzer 10 How to operate the Analyzer 11 CONFIGURATION Alere Afinion™ menus 12 Setting the configuration 13 Patient ID configuration 13 Patient ID enable/disable 13 Operator configuration 14 Operator ID enable/disable 14 Operator login expiration 14 14 Copy operator list 15 Choosing language 15 Setting date and time 15 Adjusting screen/beeper volume settings 16 QC lockout configuration 17 Select assay type 17 QC lockout 17 17 Control lot database 17 QUALITY CONTROL Why quality control testing? 18 Choosing control material 18 Handling and testing controls 18 Frequency of control testing 18 Table of contents continues on next page Yüklə 239,23 Kb. Dostları ilə paylaş:
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