7
10
Transmitting Results
1. Place handheld in Downloader or Downloader/Recharger.
2. Do not move handheld until Communication in Progress message
disappears.
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.
3. Press for Quality Tests.
MENU
3
Reportable and Reference Range
(continued)
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 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.
ß-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.
