14
7
Measured
(continued)
:
Reportable
Reference Range
Test
Units
Range
(arterial)
(venous)
pH
6.50 – 8.20
7.35 – 7.45
7.31 – 7.41
P
CO
2
mmHg
5 – 130
35 – 45
41 – 51
kPa
0.67 – 17.33
4.67 – 6.00
5.47 – 6.80
TCO
2
mmol/L (mEq/L)
5-50
23 – 27
24 – 29
(on the CHEM8+ cartridge only)
P
O
2
mmHg
5 – 800
80 – 105
kPa
0.7 – 106.6
10.7 – 14.0
Ionized Calcium/iCa
mmol/L
0.25 – 2.50
1.12 – 1.32
1.12 – 1.32
mg/dL
1.0 – 10.0
4.5 – 5.3
4.5 – 5.3
Urea Nitrogen/BUN
mg/dL
3 – 140
8 – 26
8 – 26
Urea
mmol/L
1 – 50
2.9 – 9.4
2.9 – 9.4
mg/dL
6 – 300
17 – 56
17 – 56
Hematocrit/Hct
%PCV
15 – 75
38 – 51
38 – 51
Fraction
0.15 – 0.75
0.38 – 0.51
0.38 – 0.51
Celite
®
Activated
seconds
50 – 1000
74 – 125 (Prewarm)
74– 125 (Prewarm)
Clotting Time/
84 – 139 (Nonwarm)
84 – 139 (Nonwarm)
Celite
ACT
The range from 80 - 1000 seconds has been verified through method comparison studies.
Kaolin Activated
seconds
50 – 1000
74 – 137 (Prewarm)
74 – 137 (Prewarm)
Clotting Time/
82 – 152 (Nonwarm)
82 – 152 (Nonwarm)
Kaolin
ACT
The range from 77 - 1000 seconds has been verified through method comparison studies.
Prothrombin Time/PT
INR
0.9 – 8.0
Performance characteristics have not been established for INRs above 6.0.
Troponin I / cTnI
ng/mL (µg/L)
0.00 – 50.0
0.00 – 0.03*
0.00 – 0.08**
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)
0.0 – 150.0
0.0 – 3.5***
CK-MB
***Represents the 0 to 95% range of results.
β
-Type Natriuretic
pg/mL (ng/L)
15 – 5000
<15 – 50#
Peptide / BNP
# Represents the 0 to 95% range of results.
Total Beta-Human
IU/L
5.0 – 2000.0
<5.0
Chorionic Gonadotropin
/ß-hCG
Celite is a registered trademark of Celite Corporation, Santa Barbara, CA. for its diatomaceous earth products.
Procedure
1. Turn the handheld on and press to access the Administration Menu.
2. Press 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 for Next Level if
testing another level of control.
3
1
1
1
1
MENU
Verification of Cartridges Using 2 Levels of Specified Controls
Cartridge Type Control Type
G, Crea, G3+, CG4+
TriControls
or
i-STAT controls
CHEM8+, E3+, EC4+, 6+
TriControls
EC8+, EG6+, EG7+, CG8+
ACTk, ACTc
i-STAT ACT controls
PT/INR
i-STAT PT/INR controls
cTnI
i-STAT cTnI controls
CK-MB
i-STAT CK-MB controls
BNP
i-STAT BNP controls
ß-hCG
i-STAT ß-hCG control
n
Verify that the storage conditions listed above have been maintained.
