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® S Y S T E M Operations Manual Addendum This addendum to the AxSYM System Operations Manual is being issued by Abbott Diagnostics Division to provide additional information applicable to the installation and use of the AxSYM System. This information should be used in conjunction with your AxSYM System Operations Manual. Read this information prior to using the AxSYM System. After reading this information, insert it in your Operations Manual. ©2003, Abbott Laboratories, Abbott Park, Illinois AxSYM is a registered trademark of Abbott Laboratories AxSYM® System Operations Manual Addendum 1 67888-101­July, 2003 Instrument Labeling Symbols Used on Instrument Labeling The symbols in the following table are used on the instrument's labeling: * Symbols are black with yellow background. Key to Symbols Used on Instrument Labeling REF List Number *Caution: Potential Biohazard IVD SN UNIT For In Vitro Diagnostic Use Serial Number Unit Consult Instructions for Use *Caution: Consult Instructions for Use AC Input Power LABEL VALUE Label Value Flammable Lot Number *Caution: Risk of Electric Shock Caution: Potential Biohazard *Class II Laser Product VALUE Value Store at < 24°C Store at 2-8°C Store at 15-30°C VERSION Version Disk Use by/Expiration Date Date of Manufacture Optical Standard System Software Upgrade Kit 2 AxSYM® System Operations Manual Addendum 67888-101­July, 2003 Key to Symbols Used on Instrument Labeling continued Probe Cleaning Solution REACTION VESSELS Reaction Vessels MATRIX CELLS Matrix Cells Solution 4 Line Diluent Tubing Decontamination Solution Solution 1 MUP Sample Cups Solution 3 Matrix Cell Wash ABBOTT LABORATORIES Abbott Park, IL 60064, USA Legal Manufacturer Authorized Representative If the following label is on the instrument, the instrument is CE marked to EMC Directives: · · 89/336/EEC Electromagnetic Compatibility Directive 73/23/EEC Low Voltage Directive AxSYM® System Operations Manual Addendum 3 67888-101­July, 2003 If the following label is on the instrument, the instrument is CE marked for IVD Directive 98/79/EC: Figure 1: Agency Approval The AxSYM System has been tested and found to comply with the following agency standards: · Underwriter's Laboratories: UL 3101-1 or UL 61010A-1 Electrical Equipment for Laboratory Use Part 1: General Requirements cUL: CSA c22.2 No. 1010 Safety requirements for electrical equipment for measurement, control, and laboratory use Part 1: General Requirements 21CFR Part 1040.10: Performance Standards for Light Emitting Products IEC 60825-1: Safety of Laser Products CE Marking In Vitro Diagnostic Directive 98/79/EC · · · Legal Manufacturer Authorized Representative Abbott Laboratories Abbott Park, IL 60064, USA Abbott Max-Planck-Ring 2 65205 Wiesbaden Germany +49-6122-580 4 AxSYM® System Operations Manual Addendum 67888-101­July, 2003 Supplemental Specifications to be added to Section 4: Performance Characteristics and Specifications · · · The noise l