Verification Of Cartridges Using 2 Levels Of Specified Controls; Procedure; Measured - Abbott i-STAT User Manual

Verification of Cartridges Using 2 Levels of Specified Controls
Cartridge Type
G, Crea, G3+, CG4+
CHEM8+, E3+, EC4+, 6+
EC8+, EG6+, EG7+, CG8+
ACTk, ACTc
PT/INR
cTnI
CK-MB
BNP
ß-hCG
n
Verify that the storage conditions listed above have been maintained.

Procedure

1. Turn the handheld on and press
2. Press 3 for Quality Tests.
3. Press for Control.
4. Press for i-STAT Cartridge.
5. Scan or enter Operator ID.
6. Enter the control lot number.
7. Enter the cartridge lot number.
8. Fill a cartridge with the control and close the cover.
9. Insert the cartridge into the cartridge port.
10. Enter chart page information if applicable.
11. View results on handheld's display.
12. Remove and discard cartridge when Cartridge Locked message disappears.
13. Press for Test Options on the results page and press
testing another level of control.
14
Control Type
TriControls
or
i-STAT controls
TriControls
i-STAT ACT controls
i-STAT PT/INR controls
i-STAT cTnI controls
i-STAT CK-MB controls
i-STAT BNP controls
i-STAT ß-hCG control
to access the Administration Menu.
MENU
for Next Level if

Measured

:
continued)
Test Units
pH
CO mmHg
2
kPa 0.67 – 17.33
TCO mmol/L (mEq/L)
2
(on the CHEM8+ cartridge only)
O mmHg
2
kPa
Ionized Calcium/iCa mmol/L
mg/dL
Urea Nitrogen/BUN mg/dL
Urea mmol/L
mg/dL
Hematocrit/Hct %PCV
Fraction
Celite ® Activated seconds
Clotting Time/
Celite ACT
The range from 80 - 1000 seconds has been verified through method comparison studies.
Kaolin Activated seconds
Clotting Time/
Kaolin ACT
The range from 77 - 1000 seconds has been verified through method comparison studies.
Prothrombin Time/PT INR
Performance characteristics have not been established for INRs above 6.0.
Troponin I / cTnI ng/mL (µg/L)
Performance characteristics have not been established for cTnI values above 35.00 ng/mL.
* Represents the 0 to 97.5% range of results.
** Represents the 0 to 99% range of results.
Creatinine Kinase MB/ ng/mL (µg/L)
CK-MB
***Represents the 0 to 95% range of results.
β-Type Natriuretic pg/mL (ng/L)
Peptide / BNP
# Represents the 0 to 95% range of results.
Total Beta-Human IU/L 5.0 – 2000.0
Chorionic Gonadotropin
/ß-hCG
Celite is a registered trademark of Celite Corporation, Santa Barbara, CA. for its diatomaceous earth products.
Reportable Reference Range
Range (arterial) (venous)
6.50 – 8.20 7.35 – 7.45 7.31 – 7.41
5 – 130 35 – 45 41 – 51
4.67 – 6.00 5.47 – 6.80
5-50 23 – 27 24 – 29
5 – 800 80 – 105
0.7 – 106.6 10.7 – 14.0
0.25 – 2.50 1.12 – 1.32 1.12 – 1.32
1.0 – 10.0 4.5 – 5.3 4.5 – 5.3
3 – 140 8 – 26 8 – 26
1 – 50 2.9 – 9.4 2.9 – 9.4
6 – 300 17 – 56 17 – 56
15 – 75 38 – 51 38 – 51
0.15 – 0.75 0.38 – 0.51 0.38 – 0.51
50 – 1000 74 – 125 (Prewarm) 74– 125 (Prewarm)
84 – 139 (Nonwarm) 84 – 139 (Nonwarm)
50 – 1000 74 – 137 (Prewarm) 74 – 137 (Prewarm)
82 – 152 (Nonwarm) 82 – 152 (Nonwarm)
0.9 – 8.0
0.00 – 50.0 0.00 – 0.03*
0.00 – 0.08**
0.0 – 150.0 0.0 – 3.5***
15 – 5000 <15 – 50#
<5.0
7