Eurotrol AN01637A02 HemoTrol Duo Instruction Manual

AN01637A02 HemoTrol Duo
Instruction Manual

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Intended use

HemoTrol® Duo is an assayed quality control material for professional use to verify the performance characteristics of the HemoCue® Hb 301 and the HemoCue® Hb 801  System. HemoTrol® Duo is intended for the quantitative determination of hemoglobin.

Summary and Principle
HemoTrol® Duo is a quality control material containing a known hemoglobin concentration in three clinically relevant ranges.
When measured like a patient sample, the regular use of the quality control material can provide proof of the proper functioning of the HemoCue® Hb 301 and the HemoCue®  Hb 801 System. Quality control materials should be used in accordance with local, state, and/or federal regulations or accreditation requirements.

Contents
Purified stroma-free bovine hemolysate and stabilizers.

Warnings and precautions

1. For in vitro diagnostic use.

2. Only use when the quality control has a reddish color.

3. Do not freeze.

4. Only mix by hand.

5. Caution: HemoTrol®
   A duo contains material of bovine origin. Bovine-based materials do not carry Hepatitis B Surface Antigen (HbsAg), Hepatitis C Virus (HCV), and Human Immunodeficiency Virus (HIV-1/HIV-2). The product is free from transmissible spongiform encephalopathies (TSEs). However, no test method can offer complete assurance that products derived from the bovine source material are free from infectious agents and may transmit infectious agents.

6. Follow good laboratory practice while using the product.

7. Disposition of all waste material should be in accordance with the local guidelines.

Storage and Stability

For the shelf life at 2 to 8 °C (36 – 46 °F). see the expiration date on the vial label. After opening, the product is stable at 2 to 30 °C (36 – 86 °F) for 31 days when handled according to the procedure.

Procedure
For optimal performance the product should be treated as a patient sample and instructions for use of the HemoCue® Hb 301 or HemoCue® Hb 801 System should be followed.

1. Equilibrate the vial for 15 minutes to a temperature of 15 to 30 °C (59 – 86 °F).
2. Gently mix the sample by inverting the vial 8 – 10 times before sampling.
3. Hold the vial in an upright position and tap the cap to remove liquid from the dropper tip (Figure 1.).
4. Open the cap carefully without squeezing the vial (Figure 2.).
5. Discard the first drop of the quality control liquid.
6. Apply a drop on a hydrophobic surface and use it immediately for measurement as indicated in the analyzer user manual.
7. After sampling, remove any liquid from the cap with a clean tissue and recap properly.
8. Return to the indicated storage conditions after use. The entire procedure has to be repeated upon reuse of the quality control during the open-vial time period.

Procedure
For optimal performance the product should be treated as a patient sample and instructions for use of the HemoCue® Hb 301 or HemoCue® Hb 801 System should be followed.

1. Equilibrate the vial for 15 minutes to a temperature of 15 to 30 °C (59 – 86 °F).
2. Gently mix the sample by inverting the vial 8 – 10 times before sampling.
3. Hold the vial in an upright position and tap the cap to remove liquid from the dropper tip (Figure 1.).
4. Open the cap carefully without squeezing the vial (Figure 2.).
5. Discard the first drop of the quality control liquid.
6. Apply a drop on a hydrophobic surface and use it immediately for measurement as indicated in the analyzer user manual.
7. After sampling, remove any liquid from the cap with a clean tissue and recap properly.
8. Return to the indicated storage conditions after use. The entire procedure has to be repeated upon reuse of the quality control during the open-vial time period.

Expected values
For expected values see the batch code-specific table. The means and ranges were derived from replicate analyses on the HemoCue® Hb 301 and HemoCue® Hb 801 Systems and are specific for that batch code of the product.
For further information or technical assistance, please contact:

Manufacturer
Eurocontrol B.V.
Keplerlaan 20, 6716 BS Ede, the Netherlands
Phone: +31 318 695 777
E-mail: office@eurotrol.com
www.eurotrol.com
Any serious incident that has occurred in relation to the device shall be reported to the manufacturer and the competent authority of the member state where the user and/or the patient are established.

Revision history

Stability’ section in French, Portuguese and Spanish.

All trademarks are the property of their respective owners. © 2019, Eurotrol B.V.

| CE| | Manufacturer
---|---|---|---
| Date of manufacture| | Use-by-date
| Batch code| | Catalog number
| Temperature limit| | Consult instructions for use
| Caution| **IVD**| In vitro diagnostic medical device
**CONTROL**| Control| |

References

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