Diamond Diagnostics Hct Level A Instrucciones De Uso

Manufacturer and Product Information
Diamond Diagnostics, 333 Fiske Street, Holliston, MA.
For Technical Assistance call:
Diamond Diagnostics Technical Services at 1-508-429-0450
Introduction and Intended Use:
Summary And Principle:
Reagents:
Containing:
For In Vitro diagnostic use only
Storage and Handling:
Instructions for Use
Instructions for Use
1. Before use, hold the ampule by its tip and shake it vigorously for 10 seconds.
2. Tap the liquid back into the base of the ampule
3. Open the ampule by snapping off the tip at the score. Use gauze, tissue, gloves, or an appropriate ampule opener to protect fingers from
cuts.
4. Sample the contents of the ampule according to the recommended technique provided by the analyzer manufacturer.
For optimal results, use a single sample containing at least 0.5 mL.
• Direct Aspiration- Sample the control directly from the ampule.
• Syringe Transfer- Aspirate contents of the ampule into a syringe fitted with a blunt needle (if available). Expel any air bubbles by
discarding a portion of the control into a tissue. Carefully detach the needle, and sample in the QC mode according to the recommended
technique provided by the analyzer manufacturer. For optimal results, use a 3-5 mL syringe (maximum) and a 20 gauge needle
(minimum).
5. Record the results according to the quality assurance program established for your laboratory.
Limitations
Expected Analyzer Performance:
The values in the Expected Values Chart are based on multiple determinations performed on randomly selected samples
from each lot. Diamond Diagnostics controls are measured side by side with OEM controls to ensure product performance.
Expected Values: Instrument
Hematocrit
Range
Limitations: If the instrument fails calibration or controls do not measure within acceptable range when Diamond Diagnostics products are
used, Diamond Diagnostics suggests the following:
1. Verify that the internal calibrators used to standardize the instrument are correct for the instrument, have adequate
expiration, and do not contain visually evident contamination.
2. Follow the procedures delineated within the Operator's Manual listed under Troubleshooting.
3. Ensure that all appropriate Maintenance Procedures, as listed in the Operator's Manual, have been performed.
4. If problems still exist, contact Diamond Diagnostics' Technical Service Department.
The names of various manufacturers, their instruments, and their products referred to herein may be protected by trademark or other law, and are used herein solely for purpose
of reference. Diamond Diagnostics expressly disclaims any affiliation with them or sponsorship by them.
Hct is an assayed bi-level quality control material intended for monitoring the measurement of hematocrit on analyzers as
shown in the Expected Value Charts.
There are two levels of Hct, each provided in 2.0 mL ampules. The two levels allow verification of analyzer performance
in the low and mid clinical ranges.
This product is intended to serve as a functional equivalent to pre existing material distributed by the Original Equipment
Manufacturers (OEMs).
Hct Level A, CD-570405D
Hct Level A, CD-570405D are aqueous bicarbonate solutions with other salts and preservatives.
Store Hct B at 18 to 25°C. Refer to the label on each ampule and on the box for the expiration date.
348
25.3%
23.8% - 26.8%
ECO# 6195 SOP05-1230F Revision 02 Effective Date: 10/23/12 Page 1 of 10
Hct Level A
CD-570405D: Lot R0J140
Rapidpoint 400
24.3 %
22.8 – 25.8%