McKesson Consult User manual

Consult®Hemoglobin
Testing System
USER MANUAL
Consult®Hemoglobin
Testing System
USER MANUAL

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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
Control Material ............................................................................................................................................. 6
Important Safety Instructions and Notes on Radio Interference................................................................7-8
Installation and Operation .............................................................................................................................. 9
Charging ................................................................................................................................................ 10
Configuration of Analyzer...................................................................................................................... 11
Data Transfer......................................................................................................................................... 12
Cleaning and Disinfection ..................................................................................................................... 12
Quality Control ...................................................................................................................................... 13
Disposal ................................................................................................................................................. 14
Service and Maintenance ...................................................................................................................... 14
Specimen Collection and Preparation for Analysis...................................................................................... 15
Capillary .................................................................................................................................................. 15
Venous ..................................................................................................................................................... 16
Control Sampling .................................................................................................................................... 17
Troubleshooting Guide.................................................................................................................................. 19
Expected Values............................................................................................................................................ 20
Performance Characteristics ....................................................................................................................... 20
Technical Specifications ............................................................................................................................... 21
Limitations .................................................................................................................................................... 22
References .................................................................................................................................................... 23
Consumables ................................................................................................................................................ 23
Spare Parts and Accessories........................................................................................................................ 24
Symbols Used ............................................................................................................................................... 24

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INTENDED USE
The Consult®Hemoglobin Testing System is intended for the in vitro quantitative measurement of total
hemoglobin in non-anticoagulated capillary whole blood and venous whole blood drawn in 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
consists of the Consult®Hemoglobin analyzer and specifically designed disposable cuvettes, the Consult®
Cuvettes. The Consult®Hemoglobin analyzer is only to be used with Consult®Hemoglobin Cuvettes.
• Caution: Federal law restricts this device for sale by or on the order of a physician or
other licensed practitioner (Rx only).
• CLIA Complexity for whole blood: Waived
Laboratories with a Certificate of Waiver must follow the manufacturer’s instructions for performing the test
or the test will no longer be considered CLIA waived.
PRINCIPLES OF THE PROCEDURE
Based on a photometric principle, the Consult®Hemoglobin Testing System utilizes a broad-spectrum,
multi-chromatic sensor with compensation for turbidity and scattering which measures the absorbance
of whole blood over a wide spectral range. The light path length through the cuvette cavity, in combination
with the Consult® Hemoglobin analyzer, determines the exactness of the hemoglobin measurement. The
cuvettes do not contain any reagent. The hemoglobin concentration is calculated from the measured
absorbency at multiple wavelengths.
The system is factory calibrated (and requires no further calibration) against the hemiglobincyanide (HiCN)
method, the international reference method for the determination of hemoglobin concentration in blood as
described in NCLLS H15-A3and ICSH standard 1995.1,2
CONSULT® HEMOGLOBIN TESTING SYSTEM USER MANUAL

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CONSULT® HEMOGLOBIN TESTING SYSTEM USER MANUAL
THE CONSULT®HEMOGLOBIN TESTING SYSTEM
CONSULT®HEMOGLOBIN ANALYZER
Upon delivery, open the carton on a stable surface, remove the instrument and the accessories, and check
that all the components are included and undamaged.
The Consult®Hemoglobin analyzer can be stored at 0 to 50 °C (32 to 122 °F). Temperatures of -30 to 70 °C
(-22 to 158 °F) are temporarily permitted during transport (24 hours max.).
The operating temperature of the instrument is 10 to 42 °C (50 to 107 °F). Allow the analyzer to reach
ambient temperature before use.
1. Consult®2. User Manual 3. Power Supply, Adapter Plug and
USB Cable
Consult®Hemoglobin
Testing System
USER MANUAL
Hemoglobin analyzer
A comprehensive list of consumables, spare parts and accessories for the Consult®Hemoglobin
analyzer can be found on pages 23 and 24.

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CONSULT® HEMOGLOBIN TESTING SYSTEM USER MANUAL
CONSULT®HEMOGLOBIN CUVETTES
Cuvettes are ready for use upon removal from the package. A sample volume of 10 µL is required to ensure
proper filling of the Consult®Hemoglobin Cuvette. The cuvette serves as sample collector and measuring
cuvette at the same time. The blood sample is drawn into the cavity by capillary force.
Refer to the product label and package insert of the Consult®Hemoglobin Cuvettes for information on
storage and expiry. Unused cuvettes should be stored in their original bag.
CONTROL MATERIAL
Consult®Control Solutions are available to facilitate compliance with local, state and/or federal regulations
or accreditation requirements.
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.
Hemoglobin Cuvettes Cuvettes in foil bag
Contents: 3 vials per package
900-501MCK
900-502MCK
900-503MCK
3 x Consult®Control Solution Low
3 x Consult®Control Solution Normal
3 x Consult®Control Solution High
Package configurations of Consult® Control Solutions

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CONSULT® HEMOGLOBIN TESTING SYSTEM USER MANUAL
IMPORTANT SAFETY INSTRUCTIONS AND NOTES ON RADIO INTERFERENCE
Consult®Hemoglobin Analyzer
• Only use the analyzer for the purpose described in the intended use.
• Avoid strong mechanical shocks to the analyzer.
• Do not expose the analyzer to liquids.
• After storage or transport, allow the analyzer to acclimatize to operating temperature
of 10 to 42 °C (50 to 107 °F) to prevent condensation damage.
• Do not place the Consult®Hemoglobin analyzer in direct sunlight or near a
heat source.
• Do not place the Consult®Hemoglobin analyzer in, or next to, wet areas such as
sinks or wash basins.
• Do not insert anything other than the USB cable into the socket in the back of
the analyzer.
Power Supply
• Only use the power supply provided with the instrument.
• Do not place the power supply near heat sources or expose it to direct sunlight.
• Do not use the power supply if its cable has a visible kink in it or becomes damaged.
Blood
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®
Hemoglobin analyzer. Dispose of contaminated items in proper hazardous waste containers.
• Do not expose the power supply to liquids.

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CONSULT® HEMOGLOBIN TESTING SYSTEM USER MANUAL
FCC STATEMENT
This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions:
(1) This device may not cause harmful interference, and (2) this device must accept any interference
received, including interference that may cause undesired operation.
NOTES ON RADIO INTERFERENCE
This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant
to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful
interference in a residential installation. This equipment generates, uses and can radiate radio frequency
energy and, if not installed and used in accordance with the instructions, may cause harmful interference
to radio communications. However, there is no guarantee that interference will not occur in a particular
installation. If this equipment does cause harmful interference to radio or television reception, which can be
determined by turning the equipment off and on, the user is encouraged to try to correct the interference by
one or more of the following measures:
• Reorient or relocate the receiving antenna.
• Increase the separation between the equipment and receiver.
• 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.
RF EXPOSURE INFO
The equipment complies with FCC RF exposure limits set forth for an uncontrolled environment.
Radio equipment
Bluetooth®Low Energy
Frequency Bands
2.402-2.480 GHz
Radio Frequency Power
<1 mW

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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.
The Consult®Hemoglobin analyzer comes ready for use. No installation procedure is necessary. The display
is always ON. The analyzer does not have an ON/OFF switch. When not in use, the analyzer remains in a low
power mode. The Consult®Hemoglobin analyzer may be used as a hand-held device
* VISIBLE INFORMATION DEPENDS ON ANALYZER CONFIGURATION AND STATUS OF OPERATION, SEE
SECTION 6.2
OVERVIEW OF THE CONSULT HEMOGLOBIN ANALYZER DISPLAY
Hemoglobin value
Hematocrit
(calculated)
Cuvette symbol
Time and date
Unit of measure:
g/L, g/dl or mmol/L
QC reminder
Checkmark
Shows valid reading and
passed self-check
Bluetooth symbol
(visible when activated)
USB symbol shows
USB connection status
Visible: Connected to host
Blinking: Data transfer
Battery symbol shows
battery charge status
Blinking: Battery low Flash Symbol
Visible:
Connected to
Power

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CONSULT® 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.
Charging by power supply:
1. Connect the USB cable to the analyzer.
2. Check that the adapter plug is connected to the power supply.
3. Connect the USB cable to the power supply and plug the power supply into a power outlet.
Charging by computer:
1. Connect the USB cable to the analyzer.
2. Connect the USB cable to the USB port of a computer.
 The battery symbol in the display shows the current charging state.
 The flash symbol indicates that the instrument is connected to power. Leaving the instrument connected
to a power source when the battery is fully charged will neither overcharge the battery nor decrease its
lifespan.