Summary of Contents for McKesson Consult
- Page 1 Consult Hemoglobin ® Testing System onsult Hemoglobin ® USER MANUAL sting System SER MANUAL...
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Page 3: Table Of Contents
CONSULT HEMOGLOBIN TESTING SYSTEM USER MANUAL ® TABLE OF CONTENTS Intended Use ..............................4 Principles of the Procedure ..........................4 The Consult Hemoglobin Testing System ..................... 5 ® Consult Hemoglobin Analyzer ......................5 ® Consult Hemoglobin Cuvettes ......................6 ®... -
Page 4: Intended Use
K2EDTA or lithium heparin tubes in point-of-care settings and in non-anticoagulated capillary whole blood and venous whole blood drawn in K2-EDTA tubes in blood bank settings. The Consult Hemoglobin Testing System ®... -
Page 5: The Consult ® Hemoglobin Testing System
CONSULT HEMOGLOBIN TESTING SYSTEM USER MANUAL ® A comprehensive list of consumables, spare parts and accessories for the Consult Hemoglobin ® analyzer can be found on pages 23 and 24. THE CONSULT HEMOGLOBIN TESTING SYSTEM ® CONSULT HEMOGLOBIN ANALYZER ®... -
Page 6: Consult ® Hemoglobin Cuvettes
Consult Control Solutions are produced to three concentrations that correspond to three known levels ® of human hemoglobin. Refer to the product label and package insert of the Consult Control Solution for ® further information on storage and expiration date. -
Page 7: Important Safety Instructions And Notes On Radio Interference
Always handle blood as potentially infectious. Use gloves and avoid direct skin or mucous membrane contact with donated blood, blood specimens, blood from transfer pipettes, DIFF- SAFE blood dispensers, blood from filled cuvettes or blood on the cuvette holder / Consult ® ®... - Page 8 Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. • Consult the dealer. CAUTION Changes or modifications not expressly approved by the manufacturer could void the user’s authority to operate the equipment.
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Page 9: Installation And Operation
CONSULT HEMOGLOBIN TESTING SYSTEM USER MANUAL ® INSTALLATION AND OPERATION Only healthcare professionals may use the Consult Hemoglobin analyzer. ® Please read this entire manual before using the analyzer for the first time. Follow the instructions carefully when performing the test as not doing so may result in inaccurate test results. -
Page 10: Charging
HEMOGLOBIN TESTING SYSTEM USER MANUAL ® 6.1 CHARGING The Consult Hemoglobin analyzer has a built-in rechargeable battery. The battery can be recharged by ® connecting to a power supply or to a computer via a USB cable. A USB cable and a power supply for charging the battery are supplied. -
Page 11: Configuration Of Analyzer
Troubleshooting Guide (section 9). ∙ After 9 months, the battery must be fully charged, whether or not the instrument has been in use. 6.2 CONFIGURATION OF ANALYZER The Consult Hemoglobin analyzer is delivered with the following default configuration: ® - Unit of measurement: g/dL... -
Page 12: Data Transfer
Memory: Up to 4,000 results with date and time can be stored in the memory of the analyzer. Results from the memory can be transferred to a PC using the EKF Link software. When the memory of the Consult ®... -
Page 13: Quality Control
Do not spray the instrument when cleaning, as this will damage the instrument! Only use wipes lightly dampened in water/detergent/disinfectant for cleaning and disinfection. 6.5 QUALITY CONTROL The Consult Hemoglobin Testing System is delivered factory-calibrated and requires no additional ®... -
Page 14: Disposal
CONSULT HEMOGLOBIN TESTING SYSTEM USER MANUAL ® 6.6 DISPOSAL Used Cuvettes Dispose of used cuvettes in a container for potentially infectious waste. Consult local environmental authorities for adequate disposal. Consult Analyzer ® The lithium-ion battery in the Consult Hemoglobin analyzer, has to be disposed of separately. For disposal ®... -
Page 15: Specimen Collection And Preparation For Analysis
SPECIMEN COLLECTION AND PREPARATION FOR ANALYSIS Capillary blood or venous whole blood containing K2EDTA or lithium heparin anticoagulant may be used. 7.1 CAPILLARY SAMPLING With gloved hands, take a Consult Hemoglobin Cuvette out of the foil bag and close the bag. Make sure the ®... -
Page 16: Venous
These factors commonly affect the result. Confirmation of an unexpected or unacceptable result can exclude sampling mistakes as the cause. As the Consult Hemoglobin testing method is very fast, this confirmatory ®... -
Page 17: Control Sampling
Do not wipe too close to the open end as this can draw blood out of the cuvette. 7.3 CONTROL SAMPLING 1. The Consult Hemoglobin Testing System can be verified by use of Consult Hemoglobin Control ®... - Page 18 MEASURING Insert the filled cuvette in the cuvette holder. Press down gently until you feel a “click” and hold in position until the result appears on the screen. Pull the cuvette out of the Consult Hemoglobin quickly. ® Dispose of the used cuvette in a container for potentially infectious waste. Record the test result as soon as the checkmark is shown.
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Page 19: Troubleshooting Guide
CONSULT HEMOGLOBIN TESTING SYSTEM USER MANUAL ® TROUBLESHOOTING GUIDE Symptom Possible Cause Correction Repeat the sampling. Make sure that the Unexpectedly hight / Improper sample sampling is done correctly. See pages low results 12 – 15 for more information. Contact Technical Support at... -
Page 20: Expected Values
15.82 g/dL (0.15, 0.92%) (0.22, 1.41%) Level 3 b) Accuracy The results of the comparison studies between the Consult Hemoglobin and the predicate device are ® summarized in the following table. The study was performed across four external sites. Correlation... -
Page 21: Technical Specifications
CONSULT HEMOGLOBIN TESTING SYSTEM USER MANUAL ® TECHNICAL SPECIFICATIONS 10 to 42 °C (50 to 107 °F) Operating temperature 20 to 85 % rH, non-condensing Operating humidity 5 to 95 % rH, non-condensing Storage Humidity 3000 m (with power supply) 4000 m (without power supply) -
Page 22: Limitations
22 mg/dL Sickle Cell Disease state Ammonium Ferric Citrate 30 mg/dL For further limitations of the procedure, see the Consult Cuvettes package insert. ® REFERENCES NCCLS/CLSI document H15-A3, Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood; Approved Standard-Third Edition... -
Page 23: Consumables
Tietz N, ed. Clinical Guide To Laboratory Tests, WB Saunders, 1983: 258-259. Other: Consult Hemoglobin Cuvettes package insert ® Consult Control Solution package Insert ® The following consumables, spare parts and accessories may be used with the Consult Hemoglobin ® Analyzer. CONSUMABLES Consult Hemoglobin Cuvettes (1x100 pcs) MFR # 900-100MCK ®... -
Page 24: Symbols Used
Serial Number In-vitro-Diagnostic Medical Device Reference Number Dispose of the instrument in compliance with local regulations for the disposal of electronic equipment. Do not put in domestic waste! Consult Instructions for Use Caution Manufacturer Direct current Class II equipment Bluetooth® symbol...
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