14-8
Art: 714376-00M
Rev. Date: 31-Jan-12
Ranges
The ranges displayed represent the maximum deviation expected when controls
and cartridges are performing properly.
Should results outside the ranges be obtained, refer to the Troubleshooting
section that follows the Procedure for Testing Controls.
Target Values are specific to the i-STAT System. Results obtained from these
aqueous controls with other methods may differ due to sample matrix effects.
RNA
®
MEDICAL HEMATOCRIT CONTROL
Intended Use
RNA Medical Hematocrit Control is a quality control material used for verifying
the performance of hematocrit sensors in i-STAT cartridges.
Product Description
Hematocrit controls are provided in three (3) levels for monitoring cartridge
performance at different points within the clinical range. The controls are
packaged in sealed glass ampules, each containing 1.7 mL of solution. Ampules
are packaged ten (10) per box.
Active Ingredients
This product is a buffered aqueous solution containing electrolytes and non-
conductive ingredients. This control contains no red blood cells, and no human
or biological material.
Storage
RNA Medical Hematocrit Control is stable until the expiration date stated on
the ampule when stored at temperatures of 2-25 °C. Do not freeze or expose
ampules to temperatures greater than 30 ºC.
If stored refrigerated, the control material should be equilibrated to room
temperature for at least four (4) hours prior to testing.
The product may turn slightly yellow in color over its shelf life if stored at
room temperature. This coloration is normal and does not affect product
performance.
Directions For Use
For each lot of i-STAT cartridges received, use a representational number of
cartridges to analyze multiple levels of RNA Medical Hematocrit controls.
1. Gently invert the ampule to mix the solution. Tap the ampule to
restore the liquid to the bottom of the ampule.
2. Open the ampule by snapping off the tip at the neck. Use gauze,
tissue, gloves, or an appropriate ampule opener to protect fingers
from cuts.
3. Fill and seal a cartridge and insert immediately into the analyzer.
i. Note: The Control option from the Quality Tests menu must
be used on the i-STAT 1 Analyzer for RNA Medical Hematocrit
Control.
4. Compare the i-STAT System Hematocrit result to the value
assignment sheet value. If the result is within the expected range,
use the cartridges as needed.
i. If the results are outside of the expected range, consult page 14-19
of this section for troubleshooting recommendations.
Summary of Contents for i-STAT 1
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Page 627: ...PROCEDURE MANUAL FOR THE i STAT SYSTEM 6 REV DATE 16 Oct 12 ART 714446 00L ...
Page 628: ...PROCEDURE MANUAL FOR THE i STAT SYSTEM 7 REV DATE 16 Oct 12 ART 714446 00L ...
Page 629: ...PROCEDURE MANUAL FOR THE i STAT SYSTEM 8 REV DATE 16 Oct 12 ART 714446 00L ...
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