DOC-00322-ENA.doc Page 2 of 29 ! Wescor, Inc
Table of Contents
1 INTRODUCTION .............................................................................................................................................................................3
2 SYMBOLS USED (8.2) ..................................................................................................................................................................... 5
S
YMBOLS USED ON INSTRUMENTS AND REAGENTS: .................................................................................................................................5
3 HAZARDS (8.3)................................................................................................................................................................................. 7
A. RISK AND SAFETY PHRASES.............................................................................................................................................................7
4 INTENDED PURPOSE (8.5) ......................................................................................................................................................... 11
5 IDENTIFICATION / LOT / EXPIRATION DATES (8.6) ......................................................................................................... 11
6 DETAILS FROM LABELS (8.7A AND 8.4A) ............................................................................................................................. 11
A. MANUFACTURER NAME AND ADDRESS (8.7A AND 8.4A)...............................................................................................................11
B. AUTHORIZED REPRESENTATIVE NAME AND ADDRESS (8.7A AND 8.4A)........................................................................................11
C. IDENTIFICATION OF THE DEVICE, ACCESSORY, OR SUPPLY ITEM (8.7A AND 8.4B) ........................................................................ 12
D. IN VITRO DIAGNOSTIC USE (8.7A AND 8.4G) .................................................................................................................................13
E. STORAGE AND HANDLING CONDITIONS (8.7A AND 8.4H) .............................................................................................................. 13
F. OPERATING INSTRUCTION (8.7A AND 8.4J) ....................................................................................................................................14
G. APPROPRIATE WARNINGS AND PRECAUTIONS (8.7A AND 8.4J) .....................................................................................................16
H. COMPOSITION OF CRITICAL CHEMICALS IN REAGENT PRODUCTS (8.7B)....................................................................................... 17
I. STORAGE CONDITIONS AND SHELF LIFE (8.7C) ............................................................................................................................. 18
J. PERFORMANCE OF DEVICE (8.7D) .................................................................................................................................................. 18
K. SPECIAL EQUIPMENT REQUIRED (8.7E)..........................................................................................................................................20
L. TYPE OF SPECIMEN TO BE USED (8.7F)........................................................................................................................................... 20
M. PROCEDURE FOR USE (8.7G) .......................................................................................................................................................... 21
N. INTERNAL QUALITY CONTROL (8.7K)............................................................................................................................................ 21
O. PERFORMANCE VERIFICATION, MAINTENANCE, AND SAFE WASTE DISPOSAL (8.7N) ...................................................................21
P. TROUBLESHOOTING .......................................................................................................................................................................25
Q. SETUP AND PRE-USE PROCEDURES (8.7O)...................................................................................................................................... 26
R. PROCESS FOR CLEANING, DECONTAMINATION (8.7Q) ...................................................................................................................28
S. ENVIRONMENTAL SPECIFICATIONS AND PRECAUTIONS (8.7R) ......................................................................................................29
T. DISPOSAL OF DEVICE (8.7S)...........................................................................................................................................................29
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