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.

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 A fully charged battery lasts up to 40 days / 10,000 tests of continuous use. The battery must be
charged when the last status bar is shown, at the latest when E07 is indicated on the display, see page 19,
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
- Displayed result: Hb only
- Bluetooth function: off
- Time & date: off
The actual result is displayed and transmitted at the time of measurement. It is replaced by the next
measurement without saving to the device memory.
The following additional functions can be activated and configured using EKF Link software for basic and
advanced settings (available features depending on software license). Please visit www.ekflink.com for
information on EKF Link software, or contact EKF Diagnostics or your local distributor.
Basic settings
Date & time:
The time format can be set as 24 hours or 12 hours with am/pm indicator.
The date format can be set to display the following formats:
YYYY-MM-DD
DD-MM-YYYY
MM-DD-YYYY
with the variables Y for year, M for month and D for day.
Note! The use of the device memory function requires the activation of the date and time function prior
to use.
CONSULT® HEMOGLOBIN TESTING SYSTEM USER MANUAL

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CONSULT® HEMOGLOBIN TESTING SYSTEM USER MANUAL
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®
Hemoglobin analyzer is full, the oldest results will be overwritten consecutively.
Unit setting:
The unit of measurement can be set to g/L, mmol/L or g/dL.
Values are kept in the memory using the unit set at time of measurement.
Bluetooth function:
The Bluetooth function can be activated or deactivated.
Advanced settings
Hematocrit:
Approximate hematocrit value. If this option is activated, the hematocrit value is calculated and displayed
for hemoglobin values between 12.0 and 18.0 g/dL.
If the hemoglobin is inside the normal range, an estimation of the hematocrit is obtained by multiplying
the measured hemoglobin concentration (expressed in g/dL) by factor 2.943. This calculation should not
be used outside the normal range of hemoglobin in humans, e.g. under 12.0 g/dL (7.44 mmol/L) and
above 18.0 g/dL (11.16 mmol/L). It should not be used in anemic conditions. The hematocrit is displayed
for information only and should not be used for clinical decisions.
6.3 DATA TRANSFER
The Consult®analyzer comes with a USB 2.0 bus.
For additional information on data transfer, please contact or visit www.ekflink.com for information on EKF
Link software.
6.4 CLEANING AND DISINFECTION
1. Pull the backside of the cuvette holder slightly towards you and lift up.
2. Using a swab, clean the cuvette holder with cold water or a mild detergent, followed by disinfectant.
Dry thoroughly.

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3. Reinsert the dry cuvette holder by pressing down until you feel a “click.”
4. Clean device with cold water or mild detergent, followed by disinfectant.
To disinfect the instrument, use conventional solvent-free surface disinfectants, disposable germicidal
surface wipes, or PDI Super Sani-Cloth®germicidal disposable wipes and follow labeling directions.
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
calibration prior to operation.
The Consult®Hemoglobin analyzer will perform an automatic self-check after each measurement. Passing
the self-check verifies the measurement performance and is indicated by a check mark. An error code
is displayed if the self-check fails and the analyzer will cease measuring, so there is no risk of an incorrect
result being displayed.
The Consult®Controls Solution is available to facilitate compliance with local, state and/or federal
regulations or accreditation requirements.
Run the controls as described on page 13. Control values must fall within the ranges stated on the vial labels
and insert. If controls are not in range, repeat with a new cuvette. If values are still out of range, contact
Technical Support at: 1-800-531-5535.
CONSULT® HEMOGLOBIN TESTING SYSTEM USER MANUAL

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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
of the battery, analyzer and power supply, follow the relevant regional or local waste disposal regulations.
For disposal of the control material, refer to the respective instructions for use.
6.7 SERVICE AND MAINTENANCE
The Consult®Hemoglobin analyzer does not require maintenance. For cleaning, see page 12.
If damaged, the cuvette holder, USB cable, adapter plug and the power supply can be replaced by the user.
Should the Consult®Hemoglobin analyzer fail to function as intended, try to solve the issue by using the
Troubleshooting Guide, see page 19.
Never open the analyzer or the power supply.
Any repairs which may be necessary must be carried out by the manufacturer or by authorized
personnel only.
For Technical Support, please contact:
Phone: [phone]
CONSULT® HEMOGLOBIN TESTING SYSTEM USER MANUAL
Consult®Control Solution

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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
hand is warm and relaxed. Use the middle or ring finger for sampling. Avoid fingers with rings on.
1.Disinfect and dry the puncture site.
2. Gently massage the finger towards the tip to increase blood flow. Avoid going past the first knuckle.
3. Make the incision on the upward-facing side of the fingertip, so that the blood drop sits on top of the
finger, to facilitate filling of the cuvette.
4. Apply light pressure towards the fingertip (but not past the first knuckle) until a blood drop appears.
Wipe away the first 3 drops and make sure there is a free blood flow before filling the cuvette with the
fourth drop.
5. Be sure to have a sufficient sized blood drop to fill the cuvette. Fill the cuvette completely by touching
the corner of the cuvette to the blood drop Do not refill the cuvette. If a cuvette cannot be filled in
one continuous process, or if the cuvette contains air bubbles, discard the cuvette and use a new one,
repeating steps 4 and 5.
6. Gently wipe off the excess blood on the outside of the cuvette with a gauze pad. Be sure to gently
wipe both sides. Do not wipe too close to the open end as this can draw blood out of the cuvette.
1 2 3
CONSULT® HEMOGLOBIN TESTING SYSTEM USER MANUAL

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REPEAT TESTING
Be careful to apply the procedure described in step 1-6 correctly when collecting capillary blood for
hemoglobin measurements.
The most common causes for erroneous results are the choice of an unsuitable size or type of lancet,
incorrect capillary sampling technique, restricted capillary blood flow, or the presence of tissue fluid in the
sample after pressing the fingertip too hard.
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
test can preferably be done using the same incision. Further drops following the 4th drop may be used for
testing as long as there is still a free flow of blood.
If the blood flow has decreased or stopped, another incision should be made for the confirming sample.
Repeat the procedure described in steps 1-6 and record all results from repeated sampling, including
relevant information about the reason for retesting.
7.2 VENOUS SAMPLING
If a venous sample cannot be run immediately, it may be refrigerated up to 72 hours. If the blood is
refrigerated, then the blood should be allowed to reach room temperature before testing. K2EDTA or lithium
heparin tubes may be used.
With gloved hands, take a Consult®Hemoglobin Cuvette out of the foil bag and close the bag.
1. Make sure the sample is at room temperature before testing. Mix the tube by gentle inversion at
least 8 times.
2. Place a drop of blood on to a hydrophobic surface (e.g. Parafilm) using a commercially available
transfer pipette or DIFF-SAFE®Blood Dispenser.
3. Fill the cuvette completely by touching the corner of the cuvette to the blood drop. Do not refill
5 6
4
CONSULT® HEMOGLOBIN TESTING SYSTEM USER MANUAL

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the cuvette. If a cuvette cannot be filled in one continuous process, or if the cuvette contains air
bubbles, discard the cuvette and use a new one, repeating steps 2 and 3.
4. Gently wipe off the excess blood on the outside of the cuvette with a gauze pad. Be sure to gently
wipe both sides. 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
Solution. If stored refrigerated, allow the control solution to reach room temperature first. With gloved
hands, take a Consult®Hemoglobin Cuvette out of the foil bag and close the bag. Mix the control solution
by gentle inversion 5 times immediately before sampling. Open the vial and discard the first drop.
2. Dispense a second drop of the control solution on to a hydrophobic surface (e.g. Parafilm). Fill the
cuvette completely by touching the corner of the cuvette to the drop. Do not refill the cuvette. If a cuvette
cannot be filled in one continuous process, or if the cuvette contains air bubbles, discard
the cuvette and use a new one with a new drop of control solution.
3. Gently wipe off the excess control solution on the outside of the cuvette with a gauze pad. Be sure
to gently wipe both sides. Do not wipe too close to the open end as this can draw control solution out of
the cuvette.
4. Wipe any excess material from the vial tip and cap with a clean tissue and recap the vial tightly,
immediately.
432
1
8X
321
CONSULT® HEMOGLOBIN TESTING SYSTEM USER MANUAL

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MEASURING
1. Insert the filled cuvette in the cuvette holder.
2. 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.
3. Dispose of the used cuvette in a container for potentially infectious waste. Record the test result
as soon as the checkmark is shown.
4. The result will remain on the display until replaced by the next measurement. To erase the latest
result, press down on the empty cuvette holder.
Use only completely filled cuvettes for measuring. A filled cuvette should be analyzed within 1 minute after
filling. A filled cuvette should be kept in a horizontal position until measurement.
If the Consult® Hemoglobin analyzer has been out of use for a couple of hours, an error code may appear
after the first measurement. Remove the filled cuvette, make a “blank” measurement by pressing down the
empty cuvette holder and then reinsert the filled cuvette for measurement.
CONSULT® HEMOGLOBIN TESTING SYSTEM USER MANUAL

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TROUBLESHOOTING GUIDE
Symptom
Unexpectedly hight /
low results
Error E01
Error E02
Error E03
Error E04
Error E05
Error E07
Error E08
Display blank, measuing
not possible
Possible Cause
Improper sample
Calibration lost
Sensor read error
Self-check failed
Light source too dark
Light source too bright
Battery too low to
perform measurments
Battery
completely discharged
Correction
Repeat the sampling. Make sure that the
sampling is done correctly. See pages
12 – 15 for more information.
Contact Technical Support at
1-800-531-5535.
Repeat measurement with the same cuvette.
If error persists, contact Technical Support at
1-800-531-5535.
E03 may be displayed if a filled cuvette is left
in the cuvette holder, or was removed too
slowly. In order to reset the self-check
function, press down on the empty cuvette
holder. The screen should display “---” and a
“ ”. If error persists, contact Technical
Support at 1-800-531-5535.
Remove cuvette from cuvette holder. Press
cuvette holder several times until the screen
reads “---” and a “ ” appears. If error
persists, contact Technical Support at
1-800-531-5535.
Remove cuvette from cuvette holder. Press
cuvette holder several times until the screen
reads “---” and a “ ” appears. If error
persists, contact Technical Support at
1-800-531-5535.
Recharge the battery.
To recharge the battery, connect with a power
outlet or computer and charge for a
minimum of 4 hours.If recharging fails,
contact Technical Support at 1-800-531-5535.
Measurement value
too high
Measurement value outside the
measuring range.
Hct -- % Hemoglobin value
below 12.0 or above
18.0 g/dL
None. See section 6.2 for more
information.
CONSULT® HEMOGLOBIN TESTING SYSTEM USER MANUAL

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CONSULT® HEMOGLOBIN TESTING SYSTEM USER MANUAL
EXPECTED VALUES 3  8
The unit of measure for the hemoglobin value is g/dL. The following hemoglobin values are
considered normal:
* Reference ranges are based on medically accepted published reference ranges (Dacie and Lewis, Practical
Haematology, Twelfth Edition, Elsevier Limited 2017). These ranges are for general guidance only. Each
laboratory should establish its own normal range.
PERFORMANCE CHARACTERISTICS
a) Within Run and Total Precision
Repeatability and overall reproducibility of three samples was tested over 20 days.
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.
Consult®Hemoglobin has not been evaluated for capillary samples with hemoglobin values below 8.5
g/dL as such samples are very rarely seen in the primary care setting. It is recommended that patients
showing a capillary hemoglobin of less than 8.5 g/dL are referred to a confirmatory laboratory test.
Population
Adult Male
Adult Female
Child/Adolescent
Infant
Age Range
> 22 years
>22 years
> 2 years to 21 years
1 month to 2 years
Potential Interferent
13.0 – 17.0 g/dL
12.0 – 15.0 g/dL
11.0 – 15.5 g/dL
9.4 – 16.5 g/dL
Sample
Level 1
Level 2
Level 3
Mean Hb
Concentration
7.99 g/dL
12.58 g/dL
15.82 g/dL
Within-Run
(SD, %CV)
(0.085, 1.06%)
(0.11, 0.88%)
(0.15, 0.92%)
Total
(SD, %CV)
(0.11, 1.38%)
(0.14, 1.09%)
(0.22, 1.41%)
Sample Type
EDTA
Capillary
N
344
363
Min
4.1g/dL
8.5g/dL
Max
24.5g/dL
20.1g/dL
Slope
0.9858
0.9903
Correlation
Coefficient (r)
0.986
0.963