Abbott i-STAT 1 Benutzerhandbuch - Seite 7

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Abbott i-STAT 1 Benutzerhandbuch

Storage Conditions and Preparation for Use

Cartridges
n
Store at temperatures between 2 and 8 °C (35-46 °F). Do not use after expiration
date on cartridge pouch and box.
n
Equilibrate a single cartridge for 5 minutes or a box of cartridges for 1 hour at room
temperature before opening pouches.
n
Store cartridges at room temperature for the timeframe indicated on the cartridge box.
Mark the cartridge box or cartridge pouches with the room temperature expiration date.
Do not expose to temperatures above 30 °C (86 °F). Do not return cartridges to the
refrigerator after room temperature equilibration.
n
Use cartridge immediately after opening pouch. If the pouch has been punctured,
the cartridge should not be used.
Analyzer
n
Storage/Transport temperature: -10 to 46 °C (14-115 °F).
n
The handheld's operating temperature range is 16 to 30 °C (61-86 °F).
n
Store handhelds near the testing location or in an area close to the temperature of
the testing area. Do not store handhelds near equipment that gives off heat or in
direct sunlight.

Quality Assurance

Handheld
Electronic Simulator
Perform an electronic check on each handheld in use once a day with either the internal or
external Electronic Simulator or as needed for regulatory compliance. The internal simulator
check is initiated, every 24 hours or according to a customized schedule, when a cartridge is
inserted into the cartridge port. If the internal simulator result is PASS, the cartridge test
proceeds and the simulator results are stored. If FAIL is displayed for the internal simulator,
reinsert the cartridge or use an external simulator. The external simulator check is performed
as follows:
1.
Turn the handheld on.
2.
Press
to access the Administration Menu.
MENU
3.
Press
3
for Quality Tests.
10
Reportable and Reference Range
Measured
:
(continued)
Test
Units
pH
CO
mmHg
2
kPa
TCO
mmol/L (mEq/L)
2
(on 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.
ß-Type Natriuretic
pg/mL (ng/L)
Peptide / BNP
# Represents the 0 to 95% range of results
Total Beta-Human
IU/L
Chorionic Gonadotropin
/ß-hCG
Celite is a registered trademark of Celite Corporation, Santa Barbara, CA. for its diatomaceous earth products.
(continued)
Reportable
Reference Range
Range
(arterial)
6.50 – 8.20
7.35 – 7.45
5 – 130
35 – 45
0.67 – 17.33
4.67 – 6.00
5-50
23 – 27
5 – 800
80 – 105
0.7 – 106.6
10.7 – 14.0
0.25 – 2.50
1.12 – 1.32
1.0 – 10.0
4.5 – 5.3
3 – 140
8 – 26
1 – 50
2.9 – 9.4
6 – 300
17 – 56
15 – 75
38 – 51
0.15 – 0.75
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
0.0 – 150.0
15 – 5000
5.0 – 2000.0
(venous)
7.31 – 7.41
41 – 51
5.47 – 6.80
24 – 29
1.12 – 1.32
4.5 – 5.3
8 – 26
2.9 – 9.4
17 – 56
38 – 51
0.38 – 0.51
0.00 – 0.03*
0.00 – 0.08**
0.0 – 3.5***
<15 – 50#
<5.0
7