Accu-Chek Inform II Competency Manual do Operador Página 2

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D. Alternate site capillary testing is unacceptable in a hospital setting. Due to the
potential for less vascular circulation in alternate sites, a 30 minute lag time may
occur in detecting hypoglycemia from alternate site capillary samples.
E. Patients who have peeled fresh fruit or handled other foods that contain glucose
may have falsely high glucose levels. Patients should wash their hands with
water and soap prior to having fingerstick glucose performed.
V. CALIBRATION VERIFICATION / LINEARITY
A. Linearity solution (L1 L6) and QC (L1 & L2) are performed on brand new,
replacement and Roche repaired meter by Clinical Labs POCT.
B. Linearity testing is performed to validate the reportable range. Level 1 to 6
linearity solutions are run in duplicate and results are plotted against reference
values. The ideal linearity would be a straight line.
VI. EQUIPMENT, REAGENTS, MATERIALS AND STORAGE
A. Accu-Chek Inform II Glucose Meter
B. Accu-Chek Inform II Meter base unit (docking and charging station)
C. Accu-Chek Inform II Test Strips (PMM# 1022), 50 strips per vial.
D. Accu-Chek Inform II Glucose Controls- High and Low control (PMM# 1026), each
bottle comes in 2.5mL volume.
E. Accu-Chek Inform II Linearity Kit, Level1 – Level 6 (PMM# 1023), each bottle
comes in 2.5mL volume.
F. Accu-Chek Inform II Carrying Case (call Roche Diagnostics Customer Service 1-
800-440-3638 for replacement of broken carrying case)
G. Safe T-Pro Lancets
H. Disposable Gloves
I. Alcohol Wipes
J. Gauze
K. Sani-Cloth Plus Germicidal Disposable Cloth (PMM# 60948) for cleaning meters,
base units, and base unit hubs.
L. Storage and Handling of Testing Materials and meters
1. Test Strip
a. Store the strips at room temperature 15-30°C (59 - 86°F).
b. Do not refrigerate or freeze. Strips stored at room temperature
remain stable, and once validated by performing Quality Control
testings, are good until the expiration date printed on the vial.
c. Do not use test strips beyond their expiration date.
d. Quality Control (QC) must be performed on all new vials of test
strips when first opened. The vial must be dated with
Month/Day/Year and initialed to indicate QC has been done.
e. Keep the test strips in the original container, immediately replacing
the vial cap after removing a test strip. Exposure to moisture may
cause the meter to give an error message or give an incorrect
result.
2. Code Key
Note: New test strip codes are uploaded into all meters by Clinical
Labs POCT when the new lot of strips is validated for use.
Each box of test strips contains a code key. Each code key belongs to a
single lot number and provides important information about the lot specific
properties of the test strip. The properties of the test strips are
downloaded (as a code file) from the code key using the code key reader
and sent to all meters. The code file is stored in the meter.
Rev 1, Ver 2, 9/9/2013
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