Abbott i-STAT 1 System Manual

Art: 714377-00K Rev. Date: 31-Jan-12 15-7
RNA
®
MEDICAL HEMATOCRIT CALIBRATION VERIFICATION CONTROLS
Intended Use
RNA Medical Hematocrit Calibration Verification Control is a quality control
material used for verifying the calibration and linearity of hematocrit sensors in
i-STAT cartridges.
Product Description
Hematocrit Calibration Verification Controls are provided in five (5) levels for
verifying the accuracy of hematocrit measurements throughout the reportable
range. The controls are packaged in sealed glass ampules, each containing 1.7 mL
of solution. Ampules are packaged in kits containing four (4) ampules of each level.
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 Calibration Verification Control is stable until the
expiration date stated on the ampule when stored at temperatures of 2-25 ºC. Do
not freeze or expose ampules to temperatures greater than 30 ºC.
If stored refrigerated, the calibration verification 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
1. Beginning with Level 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 (a Snapper is included for this
purpose) to protect fingers from cuts.
3. Fill and seal a cartridge and insert immediately into the analyzer.
i. Note: The CalVer option from the Quality Tests menu must
be used on the i-STAT 1 Analyzer for RNA Medical Hematocrit
Calibration Verification Control.
4. Record the results on the Data Collection and Linearity Worksheet
provided.
5. Test Levels 2, 3, 4, and 5 in the same manner. Record all values on the
worksheet.
i. Note: this product is a buffered aqueous solution containing
electrolytes and non-conductive ingredients. The only value
assigned to this fluid is for hematocrit. All other cartridge analyte
results obtained with this control material should be ignored.
Always ensure that the lot number and software revision on the value
assignment sheet matches the lot number of the vial in use and the software
revision in the analyzer.
Target values are specific to the i-STAT System. Results may differ if used with
other methods.

Abbott i-STAT 1 Specifications

General

Brand	Abbott
Model	i-STAT 1
Category	Measuring Instruments
Language	English