Instrument B-Hemoglobin (Whole blood Hemoglobin)

Data management model

Classic model

Model: Classic and Data Management

Size: 61/4x81/4x31/2 in/2 lb.

Data Transfer Capability: Data Management Model stores approximately 1000 results. Connects to PC or LIS via RS232 port.

Specifications

• Measuring range: 0-25.6 g/dL (above 25.6 g/dL, error code 999 or HHH)
• Linearity of the system: 0-23.5 g/dL ± .5 g/dL or 7% whichever is greater
• Within-run imprecision: CV% =1.2 (range 14.0-16.0 g/dL)
• Between-day imprecision: CV% = 1.7 (range 14.3-15.1 g/dL)
• Precision: CV% = 1.5
• Accuracy: ± 1.5% compared with ICSH method

Test Menu: Hemoglobin (Single Analyte)

CPT codes: 85018 (may require QW qualifier)

Test Methodology: Dual beam absorbance photometry, azide methemoglobin calibrated with ICSH.

Units in which test result is reported: USA= g/dL (can be set to mmol/L or G/L)

Sample Volume: 10 ul

Time to result: Less than 45 seconds

CLIA Classification:   Waived

Other: The HemoCue^® B-Hemoglobin Analyzer offers a quick, simple and reliable quantitative blood Hemoglobin that offers the performance of a large hematology analyzer in a easy to use format. The dual wavelength photometer corrects the Hemoglobin value for lipemia and leukocytosis. Any blood source (capillary, venous, and arterial) can be used. Transfusion decisions, EPO doses and anemia screenings can be appropriately performed immediately.

The unbreakable cuvette collects the right amount of sample and mixes the sample with the reagents. The cuvette is placed into the hand-held Analyzer, and results appear on the display screen in less than a minute.

Instrument B-Glucose (Whole blood Glucose)

Data management model

Classic model

Model: Classic and Data Management

Size: 61/4x81/4x31/2 in/2 lb.

Data Transfer Capability: Data Management Model stores approximately 1000 results. Connects to PC or LIS via RS232 port.

Specifications

• Measuring range: 0-400 mg/dl, results > 400 mg/dl will display error code (HHH or out of range)
• Linearity of the system:0-400 mg/dl
• Precision:CV% = 3.5%
• Accuracy:Neonatal: Corr. coef. = 0.970-0.980

Adults: Corr. Coef. = 0.985-0.996

Test Menu: Whole blood glucose (single analyte)

CPT codes:

• 82947: Quantitative Glucose determination
• 82950: Glucose post dose (includes glucose) direct measurement
• 82951: GTT, direct measurement, 3 specimens (includes glucose)
• 82952: GTT, direct measurement, each additional beyond 3 specimens (includes glucose)

The CPT code may require a QW qualifier

Test Methodology: Dual beam absorbance photometry using glucose dehydrogenase.

Units in which test result is reported: USA: mg/dl (can be set to mmol/l)

Sample Volume: 5 ul

Time to result: 40 to 240 seconds (concentration dependent)

CLIA Classification:  Waived

Other: The HemoCue^® B-Glucose provides the analytical performance of a large reference laboratory instrument with the operator simplicity of a "home-use" product. The design consists of a dual-wavelength photometer and a glucose dehydrogenase reaction. This combination eliminates the effects of known interferences, including no hematocrit limitations. Also, any sample source (capillary, venous, arterial, even neonatal) can be used.

The operation is virtually technique independent. Simply place the cuvette to the blood sample. The cuvette quickly and automatically aspirates the correct amount of sample and mixes the sample with the enclosed reagents. The cuvette is placed into the cuvette holder, results appear on the LCD Screen.

Other relevant information on HemoCue^® Testing Systems:

Both testing systems are now available in a Data Management version. The Data Management system allows for customizing programmable parameters, storage of patient and QC values, as well as QC lockout capabilities. The data management analyzers can then transfer data to a PC, Network or LIS via an RS232 Port. To help POCT Managers control near patient testing, HemoCue has enhanced the Hemoglobin and Glucose Data Management Testing Systems by developing analyzer and software upgrades. The Analyzer is now more user friendly with improved tracking capabilities and increased operator lockout functions. Expanded analyzer functions include bar coding, linearity, proficiency testing and more control levels. Software upgrades offer improved tracking and expanded reporting capabilities. The software is now faster and more user friendly.