Intended use
Hemo
Point
®
H2
User Manual
8
2.
Intended use
The
Hemo
Point
®
H2
system is intended for the quantitative
determination of hemoglobin (Hgb) in whole blood of adults,
infants, and children in a professional point-of-care setting. It
consists of a dedicated photometer and individual, single-use
microcuvettes filled with reagents.
Using the microcuvette, a small amount of arterial, venous or
capillary blood is taken up by capillary action. The filled cuvette is
inserted into the
Hemo
Point
®
H2
photometer, the color produced by
the chemical reaction in the cuvette is measured, and the Hgb
value is displayed. The microcuvettes are intended to be used
only once and must be disposed after use as potentially infectious
waste, in accordance with the current regulations applicable to
your establishment.
The
Hemo
Point
®
H2
system is designed for use in medical
practices and in clinical laboratories to assist in medical
diagnostic investigations. In addition it can be used in emergency
and intensive care units and in medical facilities such as blood
banks. This test system has been approved for use in
laboratories with Waived status as defined in 452 CFR
493.15(c)(a).
EKF DIAGNOSTICS INC. DISCLAIMS ALL EXPRESS AND
IMPLIED WARRANTIES OF THE MERCHANTABILITY AND
FITNESS PERTAINING TO THIS PRODUCT WHICH ARE NOT
EXPRESSLY DETAILED IN THIS PACKAGING INFORMATION
OR A WRITTEN AGREEMENT BETWEEN THE BUYER AND
SELLER OF THIS PRODUCT.
EKF DIAGNOSTICS INC. MAINTAINS THAT THIS PRODUCT
CONFORMS TO THE INFORMATION CONTAINED IN THIS
INSERT. PURCHASER MUST DETERMINE THE SUITABILITY
OF THE PRODUCT FOR THEIR PARTICULAR USE. USE
ONLY IN ACCORDANCE WITH LABELING INSTRUCTIONS.
Summary of Contents for Stanbio HemoPoint H2
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