Description

Hb pro Hemoglobin Testing System

1. Ordering Information

Standard Hb pro Hemoglobin Testing System

Components: Hb pro Hemoglobin Meter, USB Cable, Lancing Device, User Manual, 4 pcs AAA Battery, Quick Guide

Hb pro Hemoglobin Testing System with Bluetooth

Components: Hb pro Hemoglobin Meter, USB Cable, Lancing Device, User Manual, 4 pcs AAA Battery, Quick Guide

Hb pro Hemoglobin Microcuvettes

Components: 4 Canisters of 50 Microcuvettes, 1 Product Insert

2. Manufacturer Information

Company Details

China Care Medical Equipment Co.,Ltd

Address:Room B101, Zhongbang Business Building, PuXing Road No. 87, Tianhe, Guangzhou, China

Website:www.chinacaremedical.com

3. Product Clinical Background

Basic Knowledge of Hemoglobin and Hematocrit

Hemoglobin(Hb)is the protein contained in red blood cells that is responsible for delivery of oxygen to the tissues. To ensure adequate tissue oxygenation,a sufficient hemoglobin level must be maintained.

Low hemoglobin levels may be a sign of different types of anemia, iron deficiency, cancer and other diseases, thalassemia, liver disease.

High hemoglobin levels may be a sign of lung disease, polycythemia vera, heart disease.

The hematocrit(HCT)measures the volume of red blood cells compared to the total blood volume.

Product Certification

CE, SGS approved, for testing hemoglobin in human whole blood.

4. Core Product Features

Hb pro Hemoglobin Meter Features

Large,easy-to-read display; Fast, reliable hemoglobin test result within 2 seconds; Powered by batteries or via type-C USB cable; Store up to 1000 results; High accuracy without codechip required.

Hb pro Hemoglobin Cuvettes Features

Need less amount of specimen as 8uL; Extended shelf life as 36 months whether unopened or opened; No toxic reagent or active ingredient; Storage temperature:0°C-50°C.

Hb pro Hemoglobin Control Solution Features

12 month unopened shelf life; Dropper tip botles provide efficient use; Storage temperature:2°C-30°C.

5. Clinical Evaluation Study

Test Sample & Reference Method

Sample:Venous whole blood specimens with EDTA-K2 anticoagulant, Capillary blood specimens

Reference Method: ICSH reference method (HiCN method)

Linear regression of meter reading(y)VS reference value(x)with whole blood specimens

Venous Blood:Slope=1.0031,Correlation coefficient r=0.9984

Capillary Blood:Slope=0.9924,Intercept=0.7327,Correlation coefficient r=0.9982

6. Detailed Technical Specifications

Parameter List

Methodology:Spectrophotometry

Test Item: Hemoglobin (HB), Calculated HCT

Test Time:<2 seconds

Measuring Range:HB:0-26 g/dL, 0-260 g/L or 0-16.1 mmol/L;HCT:0%-75%

Specimen Type:Capillary or venous whole blood

Specimen Volume:8 μ L

Accuracy Standard:Venous blood:y=1.0031x-0.2608 r=0.9984;0-10.0g/dL:SD≤0.2g/dL;>10.0g/dL:CV≤2%

Power Source:4 AAA (LR03)Batteries orAC adapter

Battery Life:≥360 hours or 2,700 tests

Result Unit:g/dL,g/L,mmol/L

Memory Capacity:Store up to 1000 test data; Standard version supports data export via Type-C cable, Bluetooth version realizes wireless data transmission.

Auto Power-off:8 minutes idle shutdown

Operating Ambient Temperature:2℃~40℃

Dimension:190×92×52mm

Net Weight:650g(excluding batteries)