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[Application]

This product is used for calibrating (2-point calibration) the master curve of the EXTEL ® HEMO AUTO, a special-purpose reagent for the fully automatic human fecal hemoglobin analyzer, HM-JACK.

[Procedure]

Calibrate the master curve by measuring the hemoglobin standard for fecal occult blood analysis (called “standard” for short). For details about the intervals at which the master curve should be calibrated consult the instruction leaflet for the EXTEL^® HEMO AUTO. For details about the operating procedure, refer to the instruction manual for the fully automatic human fecal hemoglobin analyzer HM-JACK.

1.  Reagent Preparation

Add exactly 1mL of distilled water to dissolve. After the solution has been stood for 30 to 45 minutes at room temperature, gently turn upside down to homogenize and start using. After dissolving, the solution remains stable for 1 week when stored at 2 - 8°.

2.  Procedure

(a(a) Enter the measurement menu of the fully automatic human fecal hemoglobin analyzer HM-JACK.

(b(b) Gently mix the prepared standard solution, introduce the necessary quantity into the sample cup and place in the specified position on the specimen table.

Note:  Once you have transferred the standard solution into the test cup do not return to the vial. If the standard quantity is not sufficient do not make any addition to make up the shortage. Prepare a new sample cup instead.

(c(c)   Place the reagent in the specified position.

(d(d) Press the START key of the HM-JACK. The entire process from sampling the specimen to the processing of the data after measurement is fully automated.

3.  Entering the Standard Concentration

When the Production (lot) number of the standard has changed enter the concentration by using the barcode of the standard concentration card.

[Warnings and Precautions]

1.   The standard contains ingredients of human origin and when tested for HB antigens, HIV and HCV antibodies gives a negative result. It is possible however that other infectious factors may be present. Be sure therefore to take the same precautions as you would do when handling patient samples by wearing gloves or other protection to prevent infection.

2.   This product contains sodium azide as an antiseptic (0.1% or less). On contact with lead, it reacts vehemently with formation of highly explosive metal azides. When you discard the reagent be sure therefore to dilute and wash with plenty of water.

3.   Do not mix standards of different lot numbers for use.

4.   Do not use standards that have exceeded their shelf life or standards that have been dissolved and stood for 1 week or longer even when stored at 2-8°C.

5.   All specimens, all standards and all containers and apparatuses, including the sample cups must be either treated by anyone of the following methods or discarded in accordance with the manual in force at the respective facility for the disposal of infectious medical wastes.

·    Sterilize under pressure at 121°C in an autoclave for 15 minutes or longer. However, do not autoclave wastes containing sodium hypochlorite solutions.

·    Immerse in a sodium hypochlorite solution (with an effective chlorine concentration of over 1000ppm) for 1 hour or longer.

·    Incinerate if wastes are combustible.

6.   Do not use the containers and accessories of this product for any other purpose.