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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
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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
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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
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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
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AxSYM® System Operations Manual Addendum
67888-101July, 2003
Supplemental Specifications to be added to Section 4: Performance Characteristics and Specifications
· · · The noise level generated by the instrument during operation is less than 85 dBa. There are no special environmental specifications for storage or shipping. Floor loading requirements are shown in the following figure. Ensure that the floor where the instrument will be located is capable of supporting its weight.
NOTE: Additional transportation and delivery information is attached to the instrument's shipping crate.
180 lbs
210 lbs
Rated Floor Loading (includes 5% margin)
130 lbs Front of Instrument
205 lbs
Figure 1: AxSYM Floor Loading Requirements
Supplemental Safety Information to be Added to Section 7: Operational Precautions and Limitations Additional Electrical Hazard Information
The following information shall be added to and considered part of Section 7: Operational Precautions and Limitations in the ABBOTT AxSYM System Operations Manual. · · Use a properly grounded electrical outlet of correct voltage and current handling capability. CAUTION: Maintenance procedures may expose operators to moving parts that can potentially cause personal injury. Untrained operators should not perform these procedures.
AxSYM® System Operations Manual Addendum
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67888-101July, 2003
Additional Information to be Added to Section 9: Service and Maintenance
CAUTION: Maintenance procedures may expose operators to moving parts that can potentially cause personal injury. Untrained operators should not perform these procedures.
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AxSYM® System Operations Manual Addendum
67888-101July, 2003