59883

Self-Test
Self-Test

NovaSelf-Test

Self-Test

Self-Test
®

Analyzer

Instructions for
Use Manual
 ®
Quick Start Guide: Lipids and HbA1c
1 The 2 cartridges: 2 Allegro with
Brown is for HbA1c, and Home Screen.
Yellow is for Lipids. The 2 cartridge
bays are at
the bottom.
The printer is
on top of the
analyzer.
LED indicators are below
the Home screen
Solid green LED means
NOTE: For this Quick ready to load a cartridge.
Start Guide, the Blinking green means the
HbA1c Cartridge sample is being analyzed.
will be used. Red means not available.

3 Verify the analyzer is 4 Use the on-screen

ready to run a sample keyboard and barcode
analysis (status LED is scanner to enter any
steady green).Scan the required pre-analysis
cartridge by pressing the information. Press √ when
barcode button on the done.
home screen. The Insert Cartridge
screen will display and
the cartridge bay door will
open.

5 Open the HbA1c test 6 Wash and dry hands

cartridge and remove thoroughly with a paper
the Capillary. towel.
Select a finger stick site.
Use an alcohol pad that
does not contain glycerol
to cleanse the site and
allow to air dry.
 ®
Quick Start Guide: Lipids and HbA1c
7 Use a safety lancet to 8 Insert the end of the
puncture the finger. Capillary into the
Squeeze the finger to form center of the specimen.
a blood drop. Wipe away Draw specimen up
the first blood drop using into the Capillary until
a plain, clean, gauze pad completely filled to
containing no glycerol. the fill line. Verify that
Squeeze the finger again no air bubbles are
to form a second drop of observed.
blood.

9 Insert the Capillary back 10 Place the test cartridge

into the HbA1c Test into the open bay within
Cartridge. 2 minutes of sample
collection. Press down
with finger as shown until
the cartridge clicks into
place.
 ®
Quick Start Guide: Lipids and HbA1c
11 Press the Enter icon 12 The Test Results screen is
on the Insert displayed with the time till
Cartridge screen. The Test completion shown in the
Cartridge goes into the header bar.
analyzer; the door closes; The status LED will blink
and analysis starts. The green during sample
Status LED flashes green. analysis.
Sample results will be
displayed on the Test
Results screen as they
become available. If the
test result is questionable
or if clinical signs and
symptoms appear
inconsistent with the test
result, analyze control
solutions and retest the
specimen.

Press Home to return to

13 After the analysis is 14 the Home screen.
completed the cartridge
bay will open and the
used test cartridge may
be removed for disposal
into an appropriate
biohazard container.
Press the release
button down and lift the
cartridge up and out of
the bay as shown.
 ®
Quick Start Guide: UACR
1 The White cartridge 2 Allegro with
is for Urine Albumin Home Screen.
Creatine Ratio (UACR). The 2 cartridge
bays are at
the bottom.
The printer is
on top of the
analyzer.
LED indicators are below
the Home screen
Solid green LED means
ready to load a cartridge.
Blinking green means the
sample is being analyzed.
Red means not available.

3 Verify the analyzer is 4 Use the on-screen

ready to run a sample keyboard and barcode
analysis (status LED is scanner to enter any
steady green).Scan the required pre-analysis
cartridge by pressing the information. Press √ when
barcode button on the done.
home screen. The Insert Cartridge
screen will display and
the cartridge bay door will
open.

5 Verify that the urine 6 Remove

specimen is properly the capillary
mixed in the collection adapter from
container. the Cartridge.
 ®
Quick Start Guide: UACR
Insert capillary adaptor
7 Insert the end of the 8 into the UACR Test
Capillary into the urine
specimen. Draw specimen Cartridge.
up into the Capillary until
completely filled to the
fill line. Verify that no air
bubbles are observed.

9 Place the test cartridge 10 Press the Enter icon

into the open bay within on the Insert
5 minutes of sample Cartridge screen. The Test
collection. Press down Cartridge goes into the
with finger as shown until analyzer; the door closes;
the cartridge clicks into and analysis starts. The
place. Status LED flashes green.
 ®
Quick Start Guide: UACR
11 The Test Results screen 12 After the analysis is
is displayed with the time completed the cartridge
till completion shown in bay will open and the
the header bar. used test cartridge may
The status LED will blink be removed for disposal
green during sample into an appropriate
analysis. biohazard container.
Sample results will be Press the release
displayed on the Test button down and lift the
Results screen as they cartridge up and out of
become available. If the the bay as shown.
test result is questionable
or if clinical signs and
symptoms appear
inconsistent with the test
result, analyze control
solutions and retest the
specimen.

Press Home to return to

13 the Home screen.
NOVA BIOMEDICAL SYMBOL DIRECTORY

In vitro diagnostic medical device Batch code

Product fulfills the requirements of Directive

98/79 EC (IVDD) SN Serial Number

Caution, consult accompanying documents Temperature limitation

Consult instructions for use Use by (last day of the month)

YYYY - MM

Biological risk Electronic Waste

Authorized
EC REP Nova RepresentativeUK
Biomedical
Catalog number in the European Community

LASER RADIATION
Laser Radiation - Do Not
Stare Into Beam
DO NOT STARE INTO BEAM
CLASS 2 LASER PRODUCT
WAVELENGTH: 650 nm
MAX. OUTPUT: 1.2 mW
EN 60825-1: 2002

Manufactured by Class II/IEC 825 Laser

Product
Wavelength: 655 nm

Control
Self-Test Self-Test
Self-Test

LEVEL
Self-Test

Level Self-Test

Self-Test

Corrosive
Hazard

1
 Preface

Nova ®
Instructions for Use Manual
Ordering Information
The Nova Allegro® Instructions for Use Manual can be
ordered from Nova Biomedical Order Services. Write or call:
Nova Biomedical Corporation Telephone:1-800-822-0911
200 Prospect Street FAX: 1-800-316-1178
Waltham, MA 02454-9141 (in the U.S.A.)
U.S.A. FAX: 1-781-891-9718
(outside the U.S.A.)
Web: www.novabiomedical.com
The Allegro is manufactured in the USA by Nova Biomedical
Corporation.

EC REP Authorized Representative

Nova Biomedical UK Telephone:+ 44 1928 704040
Innovation House Fax:+ 44 1928 796792
Aston Lane South, Runcorn
Cheshire, WA7 3FY, UK

Trademark
Nova Biomedical is a Registered Trademark of Nova
Biomedical Corporation.
Allegro is a Registered Trademark of Nova Biomedical
Corporation.

Copyright
Printed in the U.S.A. Copyright 2018, Nova Biomedical
Corporation, Waltham, MA 02454-9141

i
 ®
Instructions for Use Manual Preface
Technical Assistance

For technical assistance outside the United States, call your

local Nova subsidiary or authorized distributor.

Nova Biomedical Canada Ltd. Nova Biomedical

17 - 2900 Argentia Road Deutschland GmbH
Mississauga, Ontario L5N 7X9 Hessenring 13
Canada Gebäudeteil G
Tel: 1-800-263-5999 64546 Mörfelden-Walldorf
1 905 567 7700 Germany
Fax: 1 905-567-5496 Tel: + 49 6105 450512

Nova Biomedical France Nova Biomedical Italia srl

Parc Technopolis - Bât. Sigma Via Como 19
3 avenue du Canada 1er étage 20020 Lainte Milano
Les Ulis courtaboeuf Italia
91940 Tel: +39 02 87070041
France
Tel: + 33 1 64 86 11 74 Nova Biomedical Brasil
Fax: + 33 1 64 46 24 03 Rua Massena, 107
Bairro: Jardim Canadá
Nova Biomedical UK Nova Lima – MG
Innovation House CEP: 34007-746
Aston Lane South, Runcorn Brasil
Cheshire, WA7 3FY Tel: +55 31 3360-2500
UK E-Mail:
Tel: + 44 1928 704040 [email protected]
Fax: + 44 01928 796792
Nova Biomedical KK
Nova Biomedical Iberia Mita43MT Bldg-7F
Av. Corts Catalanes 9-11 13-16 Mita 3-chome
08173 Sant Cugat Minato-ku
Barcelona Tokyo 108-0073
Spain Japan
Tel: +813-5418-4676
Fax: +813-5418-4676

ii
 Table of Contents

Contents
1 Introduction 1-1
1.1 About This Manual....................................................1-1
1.2 Safety.......................................................................1-1
1.3 Installation and Use..................................................1-3
1.4 Requirements...........................................................1-4
1.5 Intended Use, Tests Performed, and Clinical Utility..1-5
1.6 The Sample....................................................1-8
1.6.1 Handling Requirements..................................1-9

2 Getting Started 2-1

2.1 Power Up Procedure................................................2-2
2.2 Cartridge Bay Status LED........................................2-2
2.3 Screen Header.........................................................2-3
2.4 Command Buttons....................................................2-3

3 Sample Analysis 3-1

3.1 Analyzing HbA1c Sample.........................................3-1
3.1.1 HbA1c Test Result Reporting..........................3-6
3.2 Analyzing Samples for Lipids...................................3-7
3.2.1 Lipid Test Result Reporting...........................3-12
3.3 UACR Sample Analysis..........................................3-13
3.3.1 UACR Test Result Reporting.........................3-17
3.4 Analyzing a Second Test Cartridge........................3-18
3.5 The Test Results Display........................................3-19
3.6 Quality Control........................................................3-21
3.6.1 Analyzing a Quality Control Solution............3-22

59883B 2018-08 toc-1

 ®
Instructions for Use Manual
4 Reviewing Patient and QC (Data Professional Healthcare
Settings Only) 4-1
4.1 Recalling Patient (Data Professional Healthcare
Settings Only)...........................................................4-1
4.1.1 Patient Trends (Professional Healthcare
Settings Only).................................................4-4
4.2 Recalling QC Data (Professional Healthcare Settings
Only).........................................................................4-6
4.2.1 QC Data Options (Professional Healthcare
Settings Only).................................................4-8
4.3 Other Data (Professional Healthcare Settings Only).4-11
4.4 Data Management..................................................4-11
4.4.1 Exporting Samples (Professional Healthcare
Settings Only)...............................................4-12
4.4.2 Archive Samples (Professional Healthcare
Settings Only)...............................................4-13
4.4.3 Export QC (Professional Healthcare Settings
Only).............................................................4-15
4.4.4 Archive QC (Professional Healthcare Settings
Only).............................................................4-16

5 Settings (Professional Healthcare Settings Only) 5-1

5.1 QC/Linearity (Professional Healthcare Settings Only). 5-1
5.1.1 Change Lot (Professional Healthcare Settings
Only)...............................................................5-2
5.1.2 QC Lockout (Professional Healthcare Settings
Only)...............................................................5-3
5.1.3 QC Intervals (Professional Healthcare Settings
Only)...............................................................5-4
5.2 Analyzer Settings (Professional Healthcare Settings
Only).........................................................................5-6
5.2.1 Date and Time (Professional Healthcare
Settings Only).................................................5-6

toc2
 1 Introduction
5.2.2 Analyzer ID (Professional Healthcare Settings
Only)...............................................................5-8

1. Intro.
5.2.3 Printer Setup (Professional Healthcare Settings
Only)...............................................................5-8
5.3 Results Settings (Professional Healthcare Settings
Only).........................................................................5-9
5.4 Sample Fields (Professional Healthcare Settings
Only).......................................................................5-11
5.5 Operators (Professional Healthcare Settings Only)... 5-13
5.6 Service (Professional Healthcare Settings Only)....5-16
5.6.1 Touch Screen (Professional Healthcare Settings
Only).............................................................5-16
5.6.2 Error Log (Professional Healthcare Settings
Only).............................................................5-17
5.6.3 Update Software (Professional Healthcare
Settings Only)...............................................5-18
5.6.4 Left Door, Right Door Professional Healthcare
Settings Only................................................5-18
5.6.5 Device, Calibration Data, Diagnostic
(Professional Healthcare Settings Only).......5-19
5.7 Version Data (Professional Healthcare Settings Only)... 5-19

6 Troubleshooting 6-1
6.1 Codes.......................................................................6-2

A Appendix A-1
A.1 Specifications.......................................................... A-1
A.2 Traceability of Calibrators, Controls, Standards
(Professional Healthcare Settings Only).................. A-4
A.3 Reference Values (Professional Healthcare Settings
Only)........................................................................ A-5
A.4 Ordering Information................................................ A-6
A-5 Warranty.................................................................. A-7

toc3
 ®
Instructions for Use Manual

toc-2
 1 Introduction

1 Introduction

1. Intro.
This manual provides all necessary instructions for the routine
operation and upkeep of the Nova Allegro Analyzer. Please
read this manual carefully. It has been prepared to help you
attain optimum performance from your Analyzer.
WARNING: The Nova Allegro Test Cartridges contain
small parts. Keep the Test Cartridges out of
reach of children and pets.
WARNING: Blood samples and body fluids are
potential sources of infectious agents. Handle
all blood products and body fluids with care.

NOTE: Please note that Sections 4, 5, A.2, and A.3 are for
professional healthcare settings only.
This section introduces the Allegro Analyzer and covers
requirements, tests performed, procedural limitations, clinical
utility, and sample handling.

1.1 About This Manual

This manual is for the Allegro Analyzer.
Throughout this manual, NOTE: indicates especially important
information, CAUTION: indicates information that is critical to
avoid instrument damage or incorrect results, and WARNING:
indicates possible hazard to the operator.

1.2 Safety
End users must be proficient in the operating and replacement
procedures of the analyzer. The following safety procedures
must be followed.

General Safety
1. Read the safety and operating instructions before
operating the analyzer.

1-1
®
Instructions for Use Manual
2. Retain the safety and operating instructions for future
reference.
3. Observe all warnings on the analyzer and in the
operating instructions.
4. Follow all operating and use instructions.
5. Do not use the analyzer near water, for example
near a sink, etc.
6. Place the analyzer so that its location or position
does not interfere with its proper ventilation.
7. Place the analyzer away from heat sources.
8. Connect the analyzer to a power supply only of
the type described in the operating instructions or
marked on the analyzer.
9. Do not defeat the safety purpose of the polarized
or grounding type plug.
10. Route power cords so that they are not likely to
be walked on or pinched by items placed upon or
against them, paying particular attention to cords at
plugs, power sockets, and at the point where they
exit from the analyzer.
11. The analyzer should be cleaned only as recommended
by the manufacturer.
12. Take care not to let objects or liquids fall into the
analyzer.
13. Do not attempt to service the analyzer beyond that
described in the operating instructions. All other
servicing should be referred to qualified service
personnel.
 1 Introduction
Electrical Safety
1. To reduce the risk of electric shock, do not remove

1. Intro.
the cover.
2. To reduce the risk of fire or electric shock, do not
expose the analyzer to water.
3. Use Nova Part Number 52894 external power supply
to power up the analyzer.
4. Ensure that the wall outlet receptacle is properly
wired and earth grounded.
5. DO NOT use a 3-to-2 wire plug adapter.
6. DO NOT use a 2-wire extension cord or a 2-wire
multiple-outlet power strip.

Chemical and Biological Safety

1. Observe all precautionary information printed on
the original solution containers.
2. Operate the analyzer in the appropriate environment.
3. Take all necessary precautions when using
pathologic or toxic materials to prevent the generation
of aerosols.
4. Dispose of all biological waste into an appropriate
biohazard container.

1.3 Installation and Use

Prior to use of the analyzer, operators should be familiar with
Chapter 2 Getting Started and Chapter 3 Sample Analysis.

1-3
 ®
Instructions for Use Manual
1.4 Requirements
Working Area Requirements (Environmental):
Keep the working area around the system free of dirt,
corrosive fumes, vibration, and excessive temperature
changes.

Electrical Requirements:
• Operating Voltage Range: 90 - 264 VAC
• Operating Frequency: 50 - 60 Hz
• Power Consumption: Less than 100 Watts

Ambient Operating Temperature:

• 15°C to 32°C (59°F to 89.6°F)

Operate at Humidity:
• 20 to 85% without condensation

Operate at Altitude:
• up to 12,000 feet/3650 meters

Dimensions:
Height: 14.0 in (35.6 cm)
Width: 8.0 in (20.32 cm)
Depth: 15.0 in (38.1 cm)

Weight:
20.0 lb (9.1 kg)

Lifting the Analyzer:

1. One person is needed to lift the analyzer.

2. From the front of the analyzer, place your hands
under each side of the analyzer.
3. Lift the analyzer. Remember to bend your knees
and lift with your legs and not your back.
4. Place the analyzer onto a clean and flat surface.

1-4
 1 Introduction
1.5 Intended Use, Tests Performed, and Clinical Utility

1. Intro.
Intended Use
The Nova Allegro System is intended for in vitro diagnostic
use for the quantitative determination of the percent of
Hemoglobin A1c (HbA1c), Total Cholesterol, High Density
Lipoprotein (HDL) Cholesterol, and Triglycerides in capillary
whole blood obtained from the fingertip. It is also intended
for quantitative determination of Albumin and Creatinine in
urine. It is intended for use for self-testing and healthcare
professionals in clinical settings as an aid to monitor the
effectiveness of diabetes and lipid control. This system
should not be used to alter physician directed treatment
by changing any medication schedule or dosage unless
specifically instructed by a healthcare professional.

Measured Parameters
Allegro Analyzer:
HbA1c Test Cartridge
• HbA1c
UACR Test Cartridge
• Albumin
• Creatinine
Lipids Test Cartridge
• Total Cholesterol
• HDL Cholesterol
• Triglycerides

Calculated Parameters
HbA1c Test Cartridge
• eAG (Estimated Average Glucose)
UACR Test Cartridge
• UACR (Urine Albumin/Creatinine Ratio)
Lipids Test Cartridge
• LDL Cholesterol
• non-HDL Cholesterol
• TC/HDL Ratio

1-5
 ®
Instructions for Use Manual
Clinical Utility1The following list includes the clinical utility
information for each of the analytes measured on the Allegro
Analyzer.

Lipids Lipids1,2,3 are a group of fats and fat-like substances

that are important constituents of cells and sources
of energy. A lipid profile measures the level of specific
lipids in the blood.
Two important lipids, cholesterol and triglycerides,
are transported in the blood by lipoprotein
particles. Each particle contains a combination of
protein, cholesterol, triglyceride, and phospholipid
molecules. The particles measured with a lipid
profile are classified by their density into high-density
lipoproteins (HDL), low-density lipoproteins (LDL),
and very low-density lipoproteins (VLDL).
Monitoring and maintaining healthy levels of these
lipids is important in staying healthy. While the
body produces the cholesterol needed to function
properly, the source for some cholesterol is the diet.
Eating too much of foods that are high in saturated
fats and trans unsaturated fats (trans fats) or having
an inherited predisposition can result in a high level
of cholesterol in the blood. The extra cholesterol
may be deposited in plaques on the walls of blood
vessels. Plaques can narrow or eventually block
the opening of blood vessels, leading to hardening
of the arteries (atherosclerosis) and increasing the
risk of numerous health problems, including heart
disease and stroke. A high level of triglycerides
in the blood is also associated with an increased
risk of developing cardiovascular disease (CVD),
although the reason for this is not well understood.

1-6
 1 Introduction
A lipid profile typically includes:
• Total cholesterol

1. Intro.
• High-density lipoprotein cholesterol (HDL-C) — often
called "good cholesterol" because it removes excess
cholesterol and carries it to the liver for removal.
• Low-density lipoprotein cholesterol (LDL-C) — often
called "bad cholesterol" because it deposits excess
cholesterol in walls of blood vessels, which can
contribute to atherosclerosis.
• Triglycerides

UACR The (UACR4,5,6) urine albumin test or albumin/

creatinine ratio (ACR) is used to screen people
with chronic conditions, such as diabetes and high
blood pressure (hypertension) that put them at an
increased risk of developing kidney disease. Studies
have shown that identifying individuals in the very
early stages of kidney disease helps people and
healthcare providers adjust treatment. Controlling
diabetes and hypertension by maintaining tight
glycemic control and reducing blood pressure delay
or prevent the progression of kidney disease.
Albumin is a protein that is present in high
concentrations in the blood. Virtually no albumin is
present in the urine when the kidneys are functioning
properly. However, albumin may be detected in the
urine even in the early stages of kidney disease.
Creatinine, a byproduct of muscle metabolism,
is normally released into the urine at a constant
rate and its level in the urine is an indication of the
urine concentration. This property of creatinine
allows its measurement to be used to correct for
urine concentration in a random urine sample.
The American Diabetes Association has stated a
preference for the ACR for screening for albuminuria
indicating early kidney disease.

1-7
 ®
Instructions for Use Manual
HbA1c The HbA1c7 level may be useful in differentiating
between patients with and without diabetes, even in
the presence of stress-induced hyperglycemia, and
may be an ideal tool for case finding in the hospitalized
patient. Similar to previously published studies on
random hyperglycemia in hospitalized patients, it
appears that a sizable proportion of patients with
random hyperglycemia will turn out to have diabetes
upon further testing, indicating a preexistent disease
state rather than a stress response. Also, given the
often unrecognized diagnosis of diabetes in patients
with inpatient hyperglycemia and the increased
mortality independently associated with inpatient
hyperglycemia, the HbA1c level may provide a
more specific cue to the provider.
Ref.
1. National Cholesterol Education Program (NCEP). Third report of the
expert panel on detection, evaluation, and treatment of high blood
cholesterol in adults (Adult Treatment Panel III). NIH Pub. No. 02-5215.
National Heart, Lung, and Blood Institute; 2005. 284 p. Available from:
http://www.nhlbi.nih. gov/guidelines/cholesterol/atp3full.pdf.
2. Reiner Z, Catapano A. L, et al. ESC/EAS Guidelines for the management
of dyslipidaemias. European Heart Journal 2011 (32):1769-1818.
4. Ellis, D., et al.: Choice of Urine Sample Predictive of Microalbuminuria
in Patients with Insulin-Dependent Diabetes Mellitus. Am. J. Kidney
Diseases. 13:321 - 328; 1989.
5. Ginsberg, J.M., et al.: Use of Single Voided Urine Samples to Estimate
Quantitative Proteinuria. N. Eng. J. Med. 309:1543-1546; 1983.
6. Watts, G.F., et al.L The Use of Random Urine Samples to Screen for
Microalbumuria in the Diabetic Clinic. Practical Diabetes. 3:86-88; 1986.
7. Lenzi S et al., The Clinical Usefulness og Glycated Hemoglobin in
Monitoring Diabetes Mellitus: A long-Term Study. Clin Chem 1987;
33:55-56.

1.6 The Sample

HbA1c, Lipids Test Cartridge
• Capillary whole blood (finger stick)
• Sample size: HbA1c - 1.5 µL,
• Sample size: Lipids - 5 µL

UACR Test Cartridge

• Urine (preservative free) - 25 µL

1-8
 1 Introduction
1.6.1 Handling Requirements

1. Intro.
Capillary Whole Blood
Blood samples should be collected from a finger stick.

Urine
Careful attention to urine sample handling is critical to ensure
that accurate results are obtained. Urine specimens should
be collected in a clean, sterile container with a non-spill,
anti-evaporation lid.
To ensure the accuracy of the urine measurements, it is
essential that urine be analyzed within 2 hours of collection
or refrigerated at temperatures between 2 and 8˚C for
extended periods to prevent the growth of micro-organisms.

1-9
 ®
Instructions for Use Manual

1-10
 2 Getting Started

2 Getting Started
The Allegro Analyzer is pictured below.

2. Started

7
5

3
4

Figure 2.1. Allegro Analyzer

1. Touch-screen Display
2. Printer
3. Left Cartridge Bay Door
4. Right Cartridge Bay Door
5. Left Cartridge Bay Status LED
6. Right Cartridge Bay Status LED
7. Barcode Scanner

2-1
 ®
Instructions for Use Manual
2.1 Power Up Procedure
When the analyzer is powered on, it displays the Allegro
boot screen. During this time, an internal Power On Self-Test
(POST) is run. If an error should occur during the POST
it is shown on the touch screen display. Once the POST
has completed the analyzer goes through a brief Startup
sequence then displays the Home screen.

Figure 2.2. Home Screen

2.2 Cartridge Bay Status LED

A Status LED is located above each of the 2 available test
cartridge bays and indicates the status of each bay.
• A steady Green LED indicates the bay is empty and
ready for use.
• A flashing Green LED indicates the bay is in use.
• A steady Red LED indicates the analysis is complete
and the test cartridge can be removed from the bay.

2-2
 2 Getting Started
2.3 Screen Header
The Screen Header at the top of the touch screen display
shows the page name of the menu the analyzer currently is
in when not running an analysis. During a sample analysis
the header displays the next step to begin the analysis then
the time to completion once the analysis has started.

2. Started
2.4 Command Buttons
The Command Buttons are shown at the bottom of the display.
The individual buttons displayed will vary with the screen being
displayed. Buttons shown with a dark Blue background are
active, those with a Grey background are inactive.

This is the Settings (Menu) Button. Press

this button to bring up the main Menu
screen. From this screen the Operator
can set up QC/Linearity, Results
Settings, Operators, Analyzer Settings,
Sample Fields, and Service.

This is the Data button. Pressing this

button displays the Recall Data screen.
From this screen you can Search By
Identifier, display QC/Linearity Data,
display Data Management screen,
Patient List screen, or Other Data
screen.

This is the Door button. When grey it

is not active.

This is the Barcode scan button. The

Allegro uses a barcode to identify the
test cartridge, QC material and patient.

2-3
 ®
Instructions for Use Manual
This is the Home button to bring the
analyzer back to the Home screen.

This is the Up/Down button to scroll

from one data screen to the next if
there are more than one screen.

This is the Print button to print the

results.

This is the Back button to go back to

the Previous screen.

This is the Cancel button to delete any

input.

This is the Accept button to apply all

inputs.

This is the Cancel Analysis button.

This is the Enter Start Analysis button

to close door and start the analysis.

2-4
 3 Sample Analysis
3 Sample Analysis
WARNING: The analyzer utilizes a barcode scanner
containing a class 2 laser product. Do not
stare into the beam.
The Allegro Analyzer is able to measure whole blood samples
for HbA1c with the HbA1c test cartridge; Total Cholesterol, HDL
Cholesterol ,and Triglycerides with the Lipids test cartridge; and
Urine samples for Albumin and Creatinine with the UACR test
cartridge. External Quality Control material is also analyzed with the

3. Analysis
test cartridges to verify the analyzer is performing to specifications.
• The left cartridge bay can be used for either Lipids
or UACR test cartridges;
• The right cartridge bay can be used for either HbA1c
or UACR test cartridges.
For improved system efficiency, when using a UACR test
cartridge with either Lipids or HbA1c test cartridge always
start the Lipids or HbA1c analysis first and the UACR
analysis second.

3.1 HbA1c Sample Analysis

HbA1c is measured from whole blood samples using the
Allegro HbA1c test cartridge. A single-use, disposable safety
lancet is needed to puncture the finger for capillary samples.

CAUTION:
• Do not use the test cartridge if the pouch, test
cartridge, desiccant pack or capillary are damaged.
• Do not heat the cartridge.
• Do not contaminate the optical window at the
front of the test cartridge.
• Sample analysis should be started no later than 2
minutes after the test cartridge capillary is filled.
• Do not use a test cartridge that has been
dropped after the capillary has been filled and
inserted into the test cartridge.
• In professional healthcare settings, care
should be used when entering patient ID's
manually as incorrect entry could lead to
improper treatment.

3-1
 ®
Instructions for Use Manual
• Verify the capillary is filled to the designated
line to avoid overfilling or under-filling.

1. Verify the analyzer is ready to run a sample analysis

(status LED is steady green).

2. Scan the
HbA1c test
cartridge by pressing the Scan
button on the Home screen.

Figure 3.1. Scan the Cartridge Barcode

3. Use the on-screen keyboard and barcode scanner

to enter any required pre-analysis information. Press
√ when done.

Figure 3.2. Enter Patient ID Screen

4. The Insert Cartridge screen will display and the

cartridge bay door will open.

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 3 Sample Analysis

Figure 3.3. Insert Cartridge Screen for HbA1c

3. Analysis
5. Open the HbA1c test cartridge and remove the
Capillary.
Remove
Capillary

Figure 3.4. Remove the Capillary from the HbA1c Cartridge

6. Wash and dry hands thoroughly with a paper towel.

7. Select a finger stick site.
8. Use an alcohol pad that does not contain glycerol
to cleanse the site and allow to air dry.
9. Use a safety lancet to puncture the finger. Squeeze
the finger to form a blood drop. Wipe away the first
blood drop using a plain, clean, gauze pad containing
no glycerol. Squeeze the finger again to form a
second drop of blood.

Figure 3.5. Safety Lancet to Puncture the Finger

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Instructions for Use Manual
10. Insert the end of the Capillary into the center of the
specimen. Draw specimen up into the Capillary
until completely filled to the fill line. Verify that no
air bubbles are observed.

Figure 3.6. Wick Blood into Capillary to the Fill Line

11. Insert the Capillary back into the HbA1c Test

Cartridge.

Figure 3.7. Insert Capillary into the HbA1c Cartridge

12. Place the test cartridge into the open bay within 2
minutes of sample collection. Press down with
finger as shown until the cartridge clicks into place.

3-4
 3 Sample Analysis

Figure 3.8. Place Cartridge into Sample Bay

3. Analysis
13. Press the Enter icon on the Insert Cartridge
screen. The Test Cartridge goes into the analyzer;
the door closes; and analysis starts. The Status LED
flashes green.

14. The Test Results screen is displayed with the time

till completion shown in the header bar. The status
LED will blink green during sample analysis.

15. Sample results will be displayed on the Test Results

screen as they become available. If the test result
is questionable or if clinical signs and symptoms
appear inconsistent with the test result, analyze
control solutions and retest the specimen.

Figure 3.9. Test Results Screen for HbA1c

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Instructions for Use Manual
16. After the analysis is completed the cartridge bay will
open and the used test cartridge may be removed
for disposal into an appropriate biohazard container.
Press the release
button down and lift
the cartridge up and
out of the bay as
shown.

Figure 3.10. Press the Release Button

17. Press Home to return to the Home screen.

3.1.1 HbA1c Test Result Reporting

The Nova Allegro HbA1c Test Cartridge measures the total
glycated hemoglobin and the total hemoglobin concentration.
The ratio between them is proportional to the % HbA1c of
the sample. The Analyzer calculates the ratio.

• The test result is displayed as % HbA1c.

• The measurement range is 4.0-14.0% HbA1c.
• The HbA1c results are displayed in 0.1% intervals.

If a test result is below the Allegro's measurement range, 3

down arrows (↓↓↓) are displayed.
If a test result is above the Allegro's measurement range 3
up arrows (↑↑↑) are displayed.
If results outside the Allegro HbA1c measurement range
are required, analyze the sample using another method.

Estimated Average Glucose: eAG

An average glucose value derived from and based upon
the HbA1c value.
Like the HbA1c, the eAG provides an estimate of blood
glucose levels during the 2 to 3 months preceding the test.
It is used to help understand how HbA1c levels translate into
daily capillary blood glucose values. An HbA1c of 7%, for
example, translates into an eAG of 154 mg/dL; an HbA1c of
9% suggests that the average blood glucose in the past few
months was 212 mg/dL. Because the eAG value matches
3-6
 3 Sample Analysis
the units that end users and patients see when they test their
own glycemic levels, it may be more readily understandable
and a better tool for communicating how to control blood
sugar levels than the HbA1c.

3.2 Analyzing Samples for Lipids

Cholesterol, HDL Cholesterol and Triglyceride levels are
measured from whole blood samples using the Allegro
Lipids test cartridge. A single-use, disposable safety lancet
is needed to puncture the finger for capillary samples.

3. Analysis
CAUTION:
• Do not use the test cartridge if the pouch,
test cartridge, desiccant pack or capillary are
damaged.
• Do not heat the cartridge.
• Do not contaminate the optical window at the
front of the test cartridge.
• Sample analysis should be started no later than 2
minutes after the test cartridge capillary is filled.
• Do not use a test cartridge that has been
dropped after the capillary has been filled and
inserted into the test cartridge.
• In professional healthcare settings, care should
be used when entering patient ID's manually as
incorrect entry could lead to improper treatment.
• Verify the capillary is filled to the designated
line to avoid overfilling or under-filling.

1. Verify the analyzer is ready to run a sample analysis

(status LED is steady green).

2. Scan the
Lipids test
cartridge by pressing the
Scan button on the Home
screen.

Figure 3.11. Scan the Cartridge Barcode

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Instructions for Use Manual
3. Use the on-screen keyboard and barcode scanner
to enter any required pre-analysis information. Press
√ when done.

Figure 3.12. Enter Patient ID Screen

4. The Insert Cartridge screen will display and the

cartridge bay door will open.

Figure 3.13. Insert Cartridge Screen for Lipids

5. Open the Lipids test cartridge Remove

and remove the Capillary. Capillary

Figure 3.14. Remove Capillary

3-8
 3 Sample Analysis
6. Wash and then dry the patients’ hands thoroughly
with a paper towel.
7. Select a finger stick site. Use an alcohol pad that
does not contain glycerol to cleanse the site and
allow to air dry.
8. Use a single-use, disposable safety lancet to puncture
the finger then squeeze the finger to form a blood
drop. Wipe away the first blood drop using a plain,
clean, gauze pad containing no glycerol. Squeeze
the finger again to form a second blood drop.

3. Analysis
Figure 3.15. Safety Lancet to Puncture the Finger

9. Insert the end of the Capillary into the center of the

specimen. Draw specimen up into the Capillary
until completely filled to the fill line. Verify that no
air bubbles are observed.

Figure 3.16 Wick Blood into Capillary to the Fill Line

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Instructions for Use Manual
10. Insert the Capillary back into the Lipid Test Cartridge.

Insert
Capillary

Figure 3.16. Figure 3.17 Insert Capillary into the Lipid Cartridge

11. Place the test cartridge into the open bay within 2
minutes of sample collection. Press down with
finger as shown until the cartridge clicks into place.

Figure 3.17. Place Lipid Cartridge into Sample Bay

12. Press the Enter icon on the Insert Cartridge

screen. The Test Cartridge goes into the analyzer;
the door closes; and analysis starts. The light flashes
green.

13. The Test Results screen is displayed with the time

till completion shown in the header bar. The status
LED will blink green during sample analysis.

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 3 Sample Analysis
14. Sample results will be displayed on the Test Results
screen as they become available. If the test result
is questionable or if clinical signs and symptoms
appear inconsistent with the test result, analyze
control solutions and retest the specimen.

3. Analysis
Figure 3.18. Test Results Screen for Lipids

15. After the analysis is completed the cartridge bay will

open and the used test cartridge may be removed
for disposal into an appropriate biohazard container.
Press the release
button down and lift
the cartridge up and
out of the bay as
shown.

Figure 3.19. Press the Release Button

16. Press Home to return to the Home screen.

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Instructions for Use Manual
3.2.1 Lipid Test Result Reporting
The Nova Allegro Lipid Test Cartridge measures Total
Cholesterol, HDL Cholesterol and Triglycerides.

The measurement range:

Total Cholesterol is 90-500 mg/dL (2.33-12.93 mmol/L).
HDL Cholesterol is 20-100 mg/dL (0.52-2.5 mmol/L).
Triglycerides is 50-600 mg/dL (0.57-6.78 mmol/L).

If a test result is below the Allegro's measurement range, 3

down arrows (↓↓↓) are displayed.
If a test result is above the Allegro's measurement range,
3 up arrows (↑↑↑ ) are displayed.
If results outside the Allegro Lipids measurement range are
required, analyze the sample using another method.

Calculated Tests
• LDL Cholesterol
• Non-HDL Cholesterol
• Total Cholesterol/HDL Ratio

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 3 Sample Analysis
3.3 UACR Sample Analysis
Albumin and Creatinine levels are measured from fresh urine
samples using the Allegro UACR test cartridge.

CAUTION:
• Diluted samples cannot be analyzed with the
Allegro UACR test cartridge.
• Do not use the test cartridge if the pouch,
cartridge or capillary are damaged.
• Do not heat the cartridge.

3. Analysis
• Do not contaminate the optical window at the
front of the test cartridge.
• Sample analysis should be started no later
than 5 minutes after the test cartridge capillary
is filled.
• Do not use a test cartridge that has been
dropped after the capillary has been filled and
inserted into the test cartridge.
• In professional healthcare settings, care
should be used when entering patient ID's
manually as incorrect entry could lead to
improper treatment.
• Verify the capillary is filled to the designated
line to avoid overfilling or under-filling.

1. Verify the analyzer is ready to run a sample analysis

(status LED is steady green).

2. Scan the
UACR test
cartridge by pressing the Scan
button on the Home screen.

Figure 3.20. Scan the Cartridge Barcode

3. Use the on-screen keyboard and barcode scanner

to enter any required pre-analysis information. Press
√ when done.
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Instructions for Use Manual

Figure 3.21. Enter Patient ID Screen

4. The Insert Cartridge screen will display and the

cartridge bay door will open.

Figure 3.22. Insert Cartridge Screen for UACR

5. Open the UACR test cartridge and remove the

Capillary.

Remove
Capillary

Figure 3.23. Remove the Capillary from the UACR Cartridge

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 3 Sample Analysis
6. Verify that the urine specimen is properly mixed in
the collection container.
7. Insert the end of the Capillary into the urine specimen.
Draw specimen up into the Capillary until completely
filled to the fill line. Verify that no air bubbles are
observed.

3. Analysis
Figure 3.24. Draw Urine Sample into the Capillary

8. Insert Capillary back into the UACR Test Cartridge.

9. Place the test cartridge into the open bay within 5

minutes of sample collection. Press down with
finger as shown until the cartridge clicks into place.

Figure 3.25. Place Cartridge into Sample Bay

10. Press the Enter icon on the Insert Cartridge

screen. The Test Cartridge goes into the analyzer;
the door closes; and the analysis starts. The light
flashes green

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Instructions for Use Manual
11. The Test Results screen is displayed with the time
till completion shown in the header bar. The status
LED will blink green during sample analysis.

12. Sample results will be displayed on the Test Results

screen as they become available. If the test result
is questionable or if clinical signs and symptoms
appear inconsistent with the test result, analyze
control solutions and retest the specimen.

Figure 3.26. Test Results Screen for UACR

13. After the analysis is completed the cartridge bay will

open and the used test cartridge may be removed
for disposal into an appropriate biohazard container.
Press the release button down and lift the cartridge
up and out of the bay as shown.

Figure 3.27. Press the Release Button

14. Press Home to return to the Home screen.

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 3 Sample Analysis
3.3.1 UACR Test Result Reporting
The Nova Allegro UACR Test Cartridge measures albumin
and creatinine in urine samples. From these results the
analyzer calculates the UACR ratio.

• The measurement range for albumin is 5-300 mg/L

(0.5-30.0 mg/dL).
• The measurement range for creatinine 15-500 mg/
dL (1.3- 44.2 mmol/L).

3. Analysis
If a test result is below the Allegro's measurement range, 3
down arrows (↓↓↓) are displayed.
If a test result is above the Allegro's measurement range,
3 up arrows (↑↑↑) are displayed.
If results outside the Allegro UACR measurement range
are required, analyze the sample using another method.

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Instructions for Use Manual
3.4 Analyzing a Second Test Cartridge
The Allegro analyzer contains 2 analysis bays and is able
to analyze 2 different test cartridges for the same patient
at the same time. The left bay is used for the Lipids test
cartridge; the right bay is used for the HbA1c test cartridge.
UACR test cartridges can be analyzed in either the left or
the right bay. For improved analyzer efficiency when 2 test
cartridges are to be analyzed, start the HbA1c or Lipids
analysis first and the UACR analysis second.

To analyze
1. Follow the steps outlined in section 3.1 or 3.2 to
initiate an HbA1c or Lipids test cartridge analysis.
2. Once the first test cartridge analysis
has begun press the scan button
to scan the second test cartridge.
3. Verify the sample is from the same patient as the
one identified for the first test cartridge and press
Yes to continue. Press No to return to the test results
page.

Figure 3.28. Verify Patient Screen

4. Follow the steps outlined in Section 3.3 to initiate a

UACR Test Cartridge analysis.
5. Test results from both test cartridges are displayed
on the Test Results page.
6. Press Home to return to the Home screen.

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 3 Sample Analysis
3.5 The Test Results Display
Once the sample analysis is complete results for the
measured and calculated tests are shown on the display.
Each test is shown with its measured value, the unit of
measure, a color bar graph for flags and the date and time
of the analysis.

Normal Result

3. Analysis
High Result

Low Result

Critical High

Critical Low

Outside
Measurement
Range

The colored bar graph provides a visual indication of the

relative sample concentration. Green indicates the sample
result is within the normal reference range for that test,
Orange indicates the result is outside the normal reference
range but does not exceed the critical alert range. Red
indicates the result exceeds the critical alert range. All red
indicates the result is outside of the assay's measurement
range.

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Instructions for Use Manual
Test results above the assay's measurement range are
printed as ↑↑↑.

Test results below the assay's measurement range are

printed as ↓↓↓.

If an error occurred during the analysis and a result could

not be displayed, the value is left blank and the Flags icon
is replaced with indicating an error occurred.

If the test results do not fit on one page use the buttons

to scroll through the test results.

Press the button to access the Sample Information

screen to enter additional information for the current sample
analysis.

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 3 Sample Analysis
3.6 Quality Control
Quality Control (QC) solutions are used to monitor the
performance of the analyzer and the test cartridges used
with it. The expected range for the Nova Allegro Control
Solutions was determined at Nova Biomedical by using
multiple runs of each level of control on multiple instruments.
The expected range indicates the maximum deviations from
the average value that may be expected under differing
conditions for instruments operating within specifications.
Refer to Expected Ranges Table.

3. Analysis
Controls should be analyzed:
• With each new shipment of Nova Allegro Test
Cartridges
• With each new lot of Nova Allegro Test Cartridges
• At least every 30 days
• When training new operators in the correct use
of the Nova Allegro Test Cartridges (Professional
healthcare settings only)
• Anytime an unexpected test result is obtained
If local and/or federal regulations require more frequent
testing of control materials, then testing should be performed
in compliance with these regulations.

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Instructions for Use Manual
3.6.1 Analyzing a Quality Control Solution
Before analyzing Quality Control Solution, read the
Instructions for Use for the control solution.
To analyze a Quality Control solution:
1. First, scan the barcode on the
quality control solution’s label.

2. Next, scan the test cartridge barcode label. The door

opens to accept the cartridge.

Figure 3.29. Scan the Cartridge Barcode

2. Remove capillary adapter from the Test Cartridge.

Remove
Capillary

Figure 3.30. Remove Capillary Adaptor

3. Remove the control vial from the refrigerator package

and mix by gentle inversion. Do not shake. Do not
mix mechanically.
4. Use the control solution immediately or return to
2-8°C (36 to 46°F).
5. Place a droplet of control solution onto the supplied
Control Solution Prep Sheet.
6. Touch the end of the Capillary to the droplet on the
Prep Sheet, ensuring it is drawn up into the Capillary
and completely filled.

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 3 Sample Analysis
7. The control vial should remain stored at 2-8°C at all
times. If additional sampling is necessary, the time
outside of 2-8°C storage should be minimized.
8. Insert the Capillary adaptor back into the Test
Cartridge.

3. Analysis
Figure 3.31. Capillary Adaptor into Cartridge

9. Place the Test Cartridge into the cartridge carrier

within 2 minutes for HbA1c and Lipids and within
5 minutes for UACR. Press down with finger as
shown until clicks into place.

Figure 3.32. Place Cartridge into Sample Bay

10. Press the Enter icon on the analysis. The

cartridge goes into the analyzer; the door closes;
and analysis starts.

11. The Test Results screen is displayed with the time

till completion shown in the header bar. The status
LED will blink green during sample analysis.

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 ®
Instructions for Use Manual
12. Control Solution results will be displayed on the Test
Results screen as they become available.

Figure 3.33. QC Results Screen for HbA1c Shown

13. To remove the used test cartridge after the analysis

has completed, press the open door icon.
Then press the button down and
pull out the cartridge as shown
and dispose it in an appropriate
biohazard container.

Figure 3.34. Press down as Shown Above To Release the Cartridge

14. Press Home to return to the Home screen.

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 4 Reviewing Patient and QC Data

4 Reviewing Patient and QC Data

(Professional Healthcare Settings Only)
Patient and Quality Control data are stored on the analyzer
and can be recalled to review at any time. If needed, recalled
results can be viewed, reprinted, or retransmitted. To access
stored data, press the Data button.

4.1 Recalling Patient Data (Professional Healthcare Settings Only)

Patient data can be recalled by entering the patient identifier
(Patient ID, MRN Number, or Patient Name) used by the
analyzer or by choosing the patient from the Patient List.

4. Data
Figure 4.1. Recall Data Menu Screen

4-1
 ®
Instructions for Use Manual
To recall patient data using Search By Identifier:

1. Press the Search By Identifier button.

2. Enter the Patient ID, MRN Number, or Patient Name.
Then press the √ button.

Figure 4.2. Search Patient ID Screen

To recall patient data using the Patient List button:

1. Press the Patient List button.

2. Use the Up/Down buttons to scroll through all entered
patient identifiers.
3. Select the Patient to view.

Figure 4.3. Patient List Screen

4-2
 4 Reviewing Patient and QC Data
All test results for the selected patient are displayed on the
Patient Data screen.
• Press Home to return to the Home Screen.
• Press Up or Down to scroll through all of the patient’s
test results. The most recent result is at the top of
the list.
• Press Trend to display a graph of all the patient’s
test results.
• Press Data to return to the Recall Data screen.

4. Data
Figure 4.4. Patient Data Screen

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 ®
Instructions for Use Manual
4.1.1 Patient Trends (Professional Healthcare Settings Only)

The Patient Trend screen displays a graphical representation

of the patient’s historical test results.
• Press Home to return to the Home Screen.
• Press In to zoom in on the results if more detail
is needed. Press Out to zoom out if less detail is
needed.

Figure 4.5. Patient Trend HbA1c Screen

Press Options to modify the graph.

• Press Plot Low to enter the value for the low range
displayed on the graph.
• Press Plot High to enter the value for the high range
displayed on the graph.
• Press Print to print the graph on the thermal printer.
• Press Print All to print a graph of each test that has
results for the patient.
• Press X to cancel any changes and return to the
Patient Trend screen
• Press √ to save any changes and return to the Patient
Trend screen.

4-4
 4 Reviewing Patient and QC Data

Figure 4.6. Patient Trend Options Screen

To display the Patient Trend for a different test

• Press the test name button.
• Press the test name of the desired test to display

4. Data
the trend for that test.

Figure 4.7. Test Name Selection

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 ®
Instructions for Use Manual
4.2 Recalling QC Data (Professional Healthcare Settings Only)

To recall QC data press the QC/Linearity Data button.

Figure 4.8. Recall Data Screen

Select the QC lot number from the displayed list.

• Use the Up / Down buttons if active to scroll through
additional QC lots.

Figure 4.9. Select Lot/Meter Screen

4-6
 4 Reviewing Patient and QC Data
QC Data for the selected lot is displayed with the most
recent result on top.
• If active, use the Up / Down buttons to scroll through
additional results.
• Press Options for QC Data Options.

4. Data
Figure 4.10. QC Data Result Screen

To view a specific QC result, select that result from the QC

Data list.
• Press Options to display the QC Result options
screen.

Figure 4.11. QC Result Screen

4-7
 ®
Instructions for Use Manual

Figure 4.12. QC Results Options Screen

• Press Print to print the QC result

• Press Delete to delete the QC result
• Press Transmit to transmit the QC result to your lab
manager software.
• Press Statistics to display the statistics for the
selected QC lot.
• Press Levey Jennings to display the Levey Jennings
graph for the selected QC lot.

4.2.1 QC Data Options (Professional Healthcare Settings Only)

The QC Data Options screen provides 2 ways to view QC

data.
• Press Statistics to view QC Statistics for the selected
lot of QC
• Press Levey Jennings to view a Levey Jennings
graph for the selected lot of QC.

4-8
 4 Reviewing Patient and QC Data

Figure 4.13. QC Data Options Screen

QC Statistics are displayed showing the QC test name,

the Mean, the Standard Deviation (SD), the Coefficient of
Variation (CV%), and the Number (n) of results.

4. Data
• Statistics are calculated using all QC results from
the selected lot.
• Press Print to print the statistics.

Figure 4.14. QC Statistics Screen

• To display statistics for a specific date range, select

the Date Range button then enter the date range of
interest.

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Instructions for Use Manual

Figure 4.15. Statistics Date Range Screen

The Levey Jennings graph is a pictorial representation of

QC recovery over the last 30 days with the most recent
result on the right-hand side.
• Use the Left / Right buttons if active to scroll through
additional results.

Figure 4.16. Levey Jennigs Graph (Screen)

• Press the Options button to display the Levey

Jennings Options screen.
• Press Plot Low to change the lowest value displayed
on the chart.
• Press Plot High to change the highest value displayed
on the chart.
• Press Print to print a copy of the displayed Levy
Jennings chart.

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 4 Reviewing Patient and QC Data
4.3 Other Data (Professional Healthcare Settings Only)
Other Data contains Patient result data with no sample
identifier.

4. Data
Figure 4.17. Recall Data Screen

4.4 Data Management (Professional Healthcare Settings Only)

The Data Management screen has multiple functions: all
require a compatible USB drive be connected to the back
of the analyzer. If no USB drive is connected or cannot be
recognized, the buttons will be inactive (grey). If an existing
Setup or Operators list is not found on a connected USB
drive the Import button will be remain inactive.

Figure 4.18. Recall Data Screen

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Instructions for Use Manual

Figure 4.19. Data Management Screen

The analyzers setup configuration, all the choices that were

made in the Settings menu, can be exported to a USB drive
connected to the analyzer for backup purposes. If needed,
these settings can be imported back into the analyzer or
into another analyzer.
If the analyzer is configured to use Operators to identify
individual users, the list of operators can be exported to a
USB drive connected to the analyzer for backup purposes.
If needed, the list can be imported back into the analyzer
or into another analyzer.

4.4.1 Exporting Samples (Professional Healthcare Settings Only)

Patient samples can be exported to a compatible USB drive
as a comma separated values (.csv) file that can be opened
with any spreadsheet application.
NOTE: Exported samples are not deleted from the
analyzer.
To export patient samples
• Press Export Samples.
• From the Patient List, select the Patient to export.
• The analyzer automatically uses a date range that
includes all data for the selected patient. If a specific
date range is required, use the From Date / To Date
buttons to specify the date range.
4-12
 4 Reviewing Patient and QC Data
• Press Export to copy the selected data to a USB
drive.

Figure 4.20. Patient List Screen

4. Data

Figure 4.21. Export Samples Screen

4.4.2 Archive Samples (Professional Healthcare Settings Only)

Patient samples can be archived to a compatible USB drive
as a comma separated values (.csv) file that can be opened
with any spreadsheet application.

NOTE: Archived samples are deleted from the analyzer

and cannot be restored.

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 ®
Instructions for Use Manual
To Archive patient samples
• Press Archive Samples.
• From the Patient List, select the Patient to archive.
• The analyzer automatically uses a date range that
includes all data for the selected patient.
• Press Archive to copy the selected data to a USB
drive and permanently delete it from the analyzer.

Figure 4.22. Patient List Screen

Figure 4.23. Archive Samples Screen

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 4 Reviewing Patient and QC Data
4.4.3 Export QC (Professional Healthcare Settings Only)
QC data can be exported to a compatible USB drive as a
comma separated values (.csv) file that can be opened with
any spreadsheet application.
NOTE: Exported QC samples are not deleted from the
analyzer.
To export QC data,
• Press Export QC.
• From the QC Lot List, select the QC Lot to export.
• The analyzer automatically uses a date range that
includes all data for the selected lot. If a specific
date range is required, use the From Date / To Date
buttons to specify the date range.
• Press Export to copy the selected data to a USB
drive.

4. Data

Figure 4.24. Select Lot/Meter Screen and Export QC Screen

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Instructions for Use Manual
4.4.4 Archive QC (Professional Healthcare Settings Only)
QC data can be archived to a compatible USB drive as a
comma separated values (.csv) file that can be opened with
any spreadsheet application.
NOTE: Archived QC data is deleted from the analyzer and
cannot be restored.
To Archive QC data
• Press Archive QC.
• From the QC Lot List, select the QC lot to archive.
• The analyzer automatically uses a date range that
includes all data for the selected lot.
• Press Archive to copy the selected data to a USB
drive and permanently delete it from the analyzer.

Figure 4.25. Select Lot/Meter Screen and Archive QC Screen

4-16
 5 Settings

5 Settings (Professional Healthcare Settings Only)

The Settings Menu provides a means of configuring the
analyzer to meet the requirements of each location where it is
used. From the Settings Menu, Quality Control settings, Test
Result settings, Analyzer settings, and user defined Sample
Field settings can be configured. An Operators list can be
created and maintained and the Service menu accessed.

5. Settings
Figure 5.1. Menu Screen

5.1 QC/Linearity (Professional Healthcare Settings Only)

Quality Control (QC) solutions are used to monitor the
performance of the analyzer and the test cartridges used
with it. Each QC solution that will be used with the analyzer
must first be set up for use.

To setup a new QC lot, the operator must first scan the 2-D
barcode located on the package insert sheet. This barcode
contains the lot number, expiration date, and expected range
of each test in the solution. When the barcode is scanned
this information is read into the analyzer’s memory and the
lot is enabled for use. If the lot has already been setup, the
operator will be notified the lot already exists and will be
asked if they want to overwrite the existing settings.

5-1
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Instructions for Use Manual
With each new lot of QC:

1. Locate the 2-D barcode on the upper left corner of

the QC package insert sheet.
2. From the analyzer’s Home screen, press Scan to
scan the barcode and download the QC lot number,
expiration date, and expected ranges to the analyzer
memory.

5.1.1 Change Lot (Professional Healthcare Settings Only)

Once a lot of QC has been scanned into the analyzer, the
manufacturer expected ranges can be adjusted if necessary.

1. From the Settings Menu, press the QC/Linearity

button.
2. Press the Change Lot button.
3. Select the Lot number of the control to be edited.

Figure 5.2. QC/Linearity Screen to Select Lot/Meter Screen

5-2
 5 Settings
4. Select the Test to be edited then enter the High Limit
and Low Limit for that control.

Figure 5.3. QC Settings

5.1.2 QC Lockout (Professional Healthcare Settings Only)

QC Lockout prevents the analyzer from using a test cartridge
(HbA1c, Lipids, or UACR) if QC results for that cartridge

5. Settings
fall outside their expected ranges or, if a scheduled QC
has not been run.
To enable QC Lockout, toggle the QC Lockout button to
Enabled.

Figure 5.4. QC Linearity Screen

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Instructions for Use Manual
5.1.3 QC Intervals (Professional Healthcare Settings Only)
QC Intervals can be set up to ensure QC is run as scheduled
up to 3 times per day. If a scheduled QC is not run before
the designated time, the test cartridge will become locked
out until the QC is run.

To configure QC Intervals
1. From the QC/Linearity screen, press the QC Intervals
button.

Figure 5.5. QC Intervals Screen

2. Select the Test cartridge name from the drop down

list.
3. Select the QC Level from the drop down list.
4. Select Time 1 and enter the first time QC should be
run that day.
5. Time 2 and Time 3 can be utilized if the QC solution
is expected to be run more than once per day.
6. The analyzer will display an Alert Notification to
remind the operator that QC is required. An Alert
Notification can be set to display 15, 30, 45, or 60
minutes before the scheduled time to help insure
the analyzer is always ready to use.

5-4
 5 Settings

Figure 5.6. Home Screen: Attention QC Required

7. If a test cartridge for a QC Locked test is scanned

on the analyzer, a QC Locked pop-up window
is displayed. Depending on the analyzer’s
configuration, an authorized operator may bypass
the lockout and continue with testing. Otherwise,
the cartridge type will remain unavailable until the
QC has been run and passed.

5. Settings

Figure 5.7. Home Screen: QC Locked

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Instructions for Use Manual
5.2 Analyzer Settings (Professional Healthcare Settings Only)
The Analyzer Settings provides a means of configuring many
of the analyzer’s general settings including Date and Time,
display language, and computer interface.

Figure 5.8. Analyzer Settings Screen

5.2.1 Date and Time (Professional Healthcare Settings Only)

To update the analyzer’s date and time

1. Press Set Date/Time.

Figure 5.9. Date/time Screen

5-6
 5 Settings
2. Select the desired Date Format from the drop down
list: MM DD YYYY, DD MM YYYY, or YYYY MM DD.
3. Select the Date Separator to use from the drop down list.
4. Select the Time Format: 12 Hr. or 24 Hr.
5. Press the Date/Time button on the Analyzer Settings
screen.
6. Use the Year, Month, Day, Hour, and Minute buttons
to enter the correct date and time. Select AM/PM if
the 12 Hour time format is selected.

5. Settings
Figure 5.10. Set Date/Time Screen
7. Press Back to return to the Date/Time screen.
8. To set Daylight Savings, press the Daylight Savings
button.
9. Enter the start and end dates then set Daylight
Savings to Enabled.

Figure 5.11. Daylight Savings Screen

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Instructions for Use Manual
5.2.2 Analyzer ID (Professional Healthcare Settings Only)
The Analyzer ID button identifies the analyzer being used
on all patient and QC samples and reports. The analyzer ID
may consist of an alphanumeric name of no more than 12
characters. To enter an Analyzer ID, first press the Analyzer
ID button then use the on-screen keyboard to enter an ID.

5.2.3 Printer Setup (Professional Healthcare Settings Only)

The Printer Settings provide a means of setting the printing
mode to 1 of 3 settings.

Figure 5.12. Printer Settings Screen

• Manual – the user must recall test results, select the

Options button, then press Print to print a result.
• Automatic – test results are printed automatically at
the conclusion of each sample analysis.
• Query – At the conclusion of the sample analysis,
the operator is asked if they would like to print a
report.
• The printout can be customized with 2 alphanumeric
print headers.
Select Header 1 or Header 2 and use the on-
screen keyboard to enter the desired text: up to 25
characters.

5-8
 5 Settings
• If Reference and Alert ranges are not required on
the results printout, toggle the Print Ranges button
to No. If ranges are required, toggle to Yes.

5.3 Results Settings (Professional Healthcare Settings Only)

The Results Settings provide a way to select the unit of
measure for each test result and to define the normal and
critical range of that test. If the analyzer will be utilizing
slope and offset corrections, the slope and offset values
are entered here.

5. Settings
Figure 5.13. Menu Screen

From the Menu screen, press Results Settings to display

the Results Settings screen.

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Instructions for Use Manual

Figure 5.14. Results Settings Screen With Test Pulldown

1. Select the Test button then select the test name

from the displayed list you wish to configure.
2. Select the Units button then select the desired Unit
of Measure from the list.

Reference ranges are the normal low and normal high values
for the selected test. Test results that fall within these ranges
are displayed on the test results screen with a green icon.
Test results that fall outside this range will be displayed on
the test results screen with an Orange icon to indicate the
result is abnormal.
The Alert range is the critical range for the selected test.
Test results that fall outside the Alert range are displayed on
the test results screen with a red icon to indicate the result
is in a critical range.

To set the Reference and Alert Ranges

1. Select the button for the value to be entered:
Reference Low, Reference High, Alert Low, and/or
Alert High.
2. Once selected, use the on screen keyboard to enter
your laboratory’s Reference and Alert ranges.

5-10
 5 Settings

Figure 5.15. Results Settings Screen

Slope and Offset may be used to correlate the analyzer’s

results to those from a reference analyzer if there is a
significant difference between them. If you are unfamiliar
with the use of slope and offset corrections, please contact
Nova Biomedical Technical Support or your local Nova
distributor for assistance.

5. Settings
5.4 Sample Fields (Professional Healthcare Settings Only)
If needed, the Sample Fields provide a way to identify
each patient and allow the creation of up to 7 additional
information fields.

Figure 5.16. Sample Fields Screen

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Instructions for Use Manual
1. Press the Patient Identifier button and select the
patient identifier to be used on the analyzer (Patient
ID, MRN, or Name) from the list.
2. Choose if the selected Patient Identifier must be
entered after the test cartridge is scanned (After
Scan), before the analysis is complete (Before
Complete), or not required (No).

Figure 5.17. Configure Fields Screen

Up to 7 user defined fields can be enabled. To configure

an additional field:
1. Select the Field to configure: Field 1 through Field
7 button.
2. From the Configure Fields screen, select Title and
use the on-screen keyboard to enter an alphanumeric
field name: up to 25 characters long.
3. Select Type and choose the Type of field: Alphanumeric,
Date, or Time from the drop down list.
4. To enable the field, press the Enabled button and
toggle to Yes.
5. To make the field required before a result can be
printed or transmitted, press the Required button
and toggle to Yes.

5-12
 5 Settings

Figure 5.18. Configure Fields: Title, Type, Enabled, Required

5.5 Operators (Professional Healthcare Settings Only)

The analyzer can be configured to allow only users that
have been set up as an Operator to use the analyzer. This
prevents unauthorized staff from using the analyzer and
identifies which operator is using the analyzer.

When Operators are enabled, the analyzer cannot be used

5. Settings
for a sample analysis until an operator logs in. A closed
lock icon is displayed on the Home screen to indicate the
analyzer state.

Figure 5.19. Home Screens: Locked and Unlocked

To log into the analyzer

1. Press the Lock icon.

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Instructions for Use Manual
2. If prompted, enter your Operator ID.
3. If prompted, enter your Password.

Once an operator is logged into the analyzer the Lock icon

is shown as open, and the Operator ID of the logged in
operator is displayed.

To log out of the analyzer

1. Press the open Lock icon.

log out icon

Figure 5.20. Enter Password

2. Press the log out icon in the lower left corner of the
screen.

Figure 5.21. Operator Settings Screen

5-14
 5 Settings
To configure Operators
1. From the Settings Menu, press the Operators button.
2. Press Setup Password and enter a new password if
needed. All users are required to enter this password
in order to access the Settings menu.
3. Press the Login Required button and select what the
operator must enter when logging into the analyzer:
ID and Password or Password Only.
NOTE: If None is selected, operator passwords are
disabled and any existing operators will be deleted.
4. Press the Operator button and use the onscreen
keyboard to enter an alphanumeric operator identifier
of up to 18 characters
5. Press the Password button and use the onscreen
keyboard to enter an alphanumeric password of up
to 15 characters.
6. Press the Privilege Level button to select a privilege
level for that Operator.
• Level 1 operators are able to bypass QC lockout
if needed.

5. Settings
• Level 2 operators are not able to bypass QC
lockout.
7. Press Add to add a new operator.
8. Existing operators can be deleted from the operator
list if no longer applicable. Enter the Operator ID to
be deleted then Press Delete to remove that operator
from the list.

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Instructions for Use Manual
5.6 Service (Professional Healthcare Settings Only)
The Service Menu provides the operator with useful tools
and information about the analyzer. Some functions are
protected by a daily password and are for use by Technical
Support or Service personnel.

Figure 5.22. Service Menu Screen

5.6.1 Touch Screen (Professional Healthcare Settings Only)

The analyzer utilizes a touch screen for most data entry
purposes and if it is not calibrated correctly the user may
have difficulty selecting the desired input. To calibrate the
touch screen:

1. Press the Touch Screen button to display the

calibration screen.
2. Follow the instructions on the screen and press √
when done.

5-16
 5 Settings

Figure 5.23. Calibration Screen

5.6.2 Error Log (Professional Healthcare Settings Only)

The Error Log displays a list of errors that have occurred
on the analyzer and may be useful if there is a need to
troubleshoot a problem. Errors are displayed showing the
Date and Time of the event, a description of the error and

5. Settings
if the error occurred in the left or right analytical bay. For
additional detail on an error refer to the troubleshooting
section of this manual.

Figure 5.24. Error log Screen

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Instructions for Use Manual
5.6.3 Update Software (Professional Healthcare Settings Only)
Software updates are installed using the Update Software
button. The new software must first be copied to a compatible
USB drive and the drive installed in the analyzer’s USB
connector located on the back of the analyzer.

If the USB drive or the software are not recognized a

message to Install a USB Flash Drive containing the new
software is displayed.

If the USB drive and the new software are recognized you
will be prompted to press Continue to update the software.
Once the software has finished installing the analyzer will
restart and the USB drive can be removed.

Figure 5.25. Software Update Screen

5.6.4 Left Door, Right Door (Professional Healthcare Settings Only)

The Left Door and Right Door buttons open (if closed) or
close (if open) the indicated cartridge bay door.

5-18
 5 Settings

Figure 5.26. Service Menu Screen

5.6.5 Device, Calibration Data, Diagnostics

(Professional Healthcare Settings Only)
The Device, Calibration Data and Diagnostics buttons are
for use by Technical Support and Service personnel and
are not expected to be used by an operator unless it is at
their direction.

5. Settings
5.7 Version Data (Professional Healthcare Settings Only)
The Version Data button displays the currently installed
version of the Host, Right Bay Module and Left Bay Module
software.

Figure 5.27. Service Menu Screen

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Instructions for Use Manual

5-20
 6 Troubleshooting

6 Troubleshooting
If a system problem is detected an error code may be
displayed on the screen and recorded in the error log. This
section lists the errors and messages, what they mean and
corrective actions.

FOR TECHNICAL ASSISTANCE:

Contact the local Nova Biomedical Sales Office or

Authorized Nova Allegro Distributor

WARNING: Body fluids are potential sources of

infectious agents. Handle all blood products
and body fluids with care. Gloves and
protective clothing are recommended.

6. TrShoot.

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 ®
Instructions for Use Manual
6.1 Codes

Error Code Description / Corrective Action

xxx Software The analyzer software runs continuously
when the analyzer is powered on. In
(xxx will be the event a software error is detected
reported as an a numeric software code is displayed
actual number.) and logged in the error log. If a software
error occurs:
1. Unplug the analyzer for 30 seconds
then power it back on.
2. If the problem reoccurs please contact
Technical Support.
xxx Hardware The analyzer monitors all internal
electronic and electro-mechanical
(xxx will be assemblies during operation. If a
reported as an problem is detected a numeric hardware
actual number.) code is displayed and logged in the error
log. If a hardware error occurs:
1. Unplug the analyzer for 30 seconds
then power it back on.
2. If the problem reoccurs please contact
Technical Support.
Door Failure A cartridge bay door was not able to
completely open or close.
1. Confirm there are no objects interfering
with door operation.
2. If the problem reoccurs please contact
Technical Support.

6-2
 6 Troubleshooting

Temperature The analyzer temperature was out of

operational limits when an analysis was
attempted.
1. If the analyzer has been turned off allow
additional time for the internal heating
circuit to warm up.
2. Check that there is sufficient ventilation
around the analyzer.
3. Unplug the analyzer for 30 seconds
then power it back on.
4. If the problem continues please contact
Technical Support.
Tip Present An internal Test Cartridge pipette tip was
detected when not expected.
1. Repeat the test using a new test
cartridge.
2. If the problem reoccurs please contact
Technical Support.
Tip Not Present An internal Test Cartridge pipette tip was
not detected when expected.
1. Repeat the test using a new test
cartridge.
2. If the problem reoccurs please contact
Technical Support.
6. TrShoot.
Capillary Holder An internal Test Cartridge capillary
Present holder was detected when not expected.
1. Repeat the test using a new test
cartridge.
2. If the problem reoccurs please contact
Technical Support.
Capillary Holder An internal Test Cartridge capillary
Not Present holder was not detected when expected.
1. Repeat the test using a new test
cartridge.
2. If the problem reoccurs please contact
Technical Support.

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Instructions for Use Manual
Cover Present An internal Test Cartridge cover was
detected when not expected.
1. Repeat the test using a new test
cartridge.
2. If the problem reoccurs please contact
Technical Support.
Cover Not An internal Test Cartridge cover was not
Present detected when expected.
1. Repeat the test using a new test
cartridge.
2. If the problem reoccurs please contact
Technical Support.
HbA1c Bad A problem with the HbA1c test cartridge
Cartridge was detected.
1. Repeat the test using a new test
cartridge.
2. If the problem reoccurs please contact
Technical Support.
HbA1c Bad A problem with the sample in the HbA1c
Sample test cartridge was detected.
1. Repeat the test using a new test
cartridge.
2. If the problem reoccurs please contact
Technical Support.
U.Alb Bad A problem with the UACR test cartridge
Cartridge was detected.
1. Repeat the test using a new test
cartridge.
2. If the problem reoccurs please contact
Technical Support.
U.Alb Bad A problem with the sample in the UACR
Sample test cartridge was detected.
1. Repeat the test using a new test
cartridge.
2. If the problem reoccurs please contact
Technical Support.

6-4
 6 Troubleshooting

Lipid Bad A problem with the Lipids test cartridge

Cartridge was detected.
1. Repeat the test using a new test
cartridge.
2. If the problem reoccurs please contact
Technical Support.
HDL Bad A problem with the Lipids test cartridge
Cartridge was detected.
3. Repeat the test using a new test
cartridge.
4. If the problem reoccurs please contact
Technical Support.
HDL Read A problem with the sample in the Lipids
test cartridge was detected.
1. Repeat the test using a new test
cartridge.
2. If the problem reoccurs please contact
Technical Support.
TC Bad Cartridge A problem with the Lipids test cartridge
was detected.
1. Repeat the test using a new test
cartridge.
2. If the problem reoccurs please contact
Technical Support.
6. TrShoot.
TC Read A problem with the sample in the Lipids
test cartridge was detected.
1. Repeat the test using a new test
cartridge.
2. If the problem reoccurs please contact
Technical Support.

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 ®
Instructions for Use Manual

Hct Range During the analysis, sample readings

detected a Hematocrit concentration
outside the acceptable range.
1. Repeat the test using a new test
cartridge.
2. If the error occurs only on one patient
the sample may need to be tested on
an alternate method.
3. If the problem continues please contact
Technical Support.
Sample Type During the analysis sample readings
were not consistent with the expected
sample type.
1. Repeat the test using a new test
cartridge.
2. If the error occurs only on one patient
the sample may need to be tested on
an alternate method.
3. If the problem continues please contact
Technical Support.
↑↑↑ The sample result is above the analytical
measurement range.
1. Repeat the test using a new test
cartridge.
2. If the error occurs only on one patient
the sample may need to be tested on
an alternate method.
3. If the problem continues please contact
Technical Support.
↓↓↓ The sample result is below the analytical
measurement range.
1. Repeat the test using a new test
cartridge.
2. If the error occurs only on one patient
the sample may need to be tested on
an alternate method.
3. If the problem continues please contact
Technical Support.

6-6
 Appendix A

A. Appendix
Appendix A includes analyzer specifications, performance
data, solutions and reagents, consumable lists, reference
information, and warranty for the Nova Allegro Analyzer.

A.1 Specifications
Measurement Range:

HbA1c
Operating Range 4.0 - 14.0 %
Sample Type Whole Blood Capillary Finger
Stick
Sample Volume 1.5 µL
Analysis Time <6.5 Minutes
Within Run Imprecision <4%
Day-to-Day Imprecision <5%

Urine Albumin Creatinine Ratio

Operating Range 5 -300 mg/L
Albumin 0.5-30 mg/dL
Operating Range 1.3 - 44.2 mmol/L
Creatinine 15 - 500 mg/dL
Sample Type Urine
Sample Volume 25 µL
Appendix A

Analysis Time <7 Minutes

Within Run Imprecision <6% Albumin
Day-to-Day Imprecision <6% Albumin
Within Run Imprecision <5% Creatinine
Day-to-Day Imprecision <5.5% Creatinine

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 ®
Instructions for Use Manual
Lipid Operating Range
Total Cholesterol 90 - 500 mg/dL
2.33 - 12.93 mmol/L
HDL Cholesterol 20 - 100 mg/dL
0.52 - 2.59 mmol/L
Triglycerides 50 - 600 mg/dL
0.57 - 6.78 mmol/L
LDL Cholesterol Calculated
Non-HDL Cholesterol Calculated
Cholesterol/HDL Ratio Calculated
Sample Type Whole Blood Capillary Finger
Stick
Sample Volume 5 µL
Analysis Time <10 Minutes
Within Run Imprecision <4%
Total Cholesterol
Within Run Imprecision CV%<4% or SD <5.0
HDL Cholesterol whichever is greater
Within Run Imprecision <5%
Triglycerides
Day-to-Day Imprecision <5%
Total Cholesterol
Day-to-Day Imprecision CV%<6% or SD <5.0
HDL Cholesterol whichever is greater
Day-to-Day Imprecision <7.5%
Triglycerides

A-2
 Appendix A
Dimensions:
Width: 20.32 cm (8 in)
Height: 35.6 cm (14 in)
Depth: 38.1 cm (15 in)
Weight: 10.43 kg (23 lb)
Power: 90 - 264 VAC, 50/60 Hz
Interfaces: ASTM Protocol, via serial RS323
TCP/IP, POCT1-A2,HL7
Printer: Built-in thermal
Methodology:
HbA1c: Particle Enhanced Immuno-
Agglutination Assay
T Cholesterol: Immunoenzyme Colorimetric Assay
HDL Cholesterol: Immunoenzyme Colorimetric Assay
Triglycerides: Immunoenzyme Colorimetric Assay
Albumin: Immunocolorimetric Assay
Creatinine: Colorimetric Assay

A.2 Traceability of Calibrators, Controls, and Standards

(Professional Healthcare Settings Only)
Traceability:
The Nova Allegro HbA1c assay has successfully completed
the NGSP certificate program and is traceable to the Diabetes
Control and Complications Trial Reference method.

Nova Allegro HbA1c: The standard used for Nova Allegro

HbA1c Test Cartridge is traceable to the CDC Designated
Comparison Method (DCM), reference method used is Tosoh
G8 (Tosoh Bioscience, San Francisco, CA).
Appendix A

Nova Allegro UACR (Urine Albumin, Creatinine): The

microalbumin or albumin standards used for Nova Allegro
UACR Test Cartridge are traceable to European Reference
Material ERM DA 470K. The creatinine standards used for
Nova’s products are traceable to NIST SRM 914a Reference.

Nova Allegro Lipids (HDL, Total Cholesterol, and

Triglycerides): The HDL standards used for Nova Allegro

A-3
 ®
Instructions for Use Manual
Lipids Test Cartridge are traceable to the CDC Designated
Comparison Method (DCM) reference method of the CRMLN
National Cholesterol Education Program accuracy base.
The Cholesterol standards used for Nova’s products are
traceable to the National Reference System for Cholesterol
CDC Abel Kendall method. They are also traceable to
NIST Standard Reference Material 911. The Triglyceride
standards are traceable to the American Chemical Society
(ACS) glycerol anhydrous chemical.

Limit of Blank (LoB), Limit of Detection (LoD), and Limit

of Quantitation (LoQ) Data:

UACR only
Stdev
Claimed
Units LOB LOD LOQ for
Range
LOQ
Albumin (mg/L) 1.2 1.729 1.3 0.3227 5 - 300

Creatinine (mg/dL) 0.0 0.925 2.3 0.5625 15 - 500

A-4
 Appendix A
A.3 Reference Values (Professional Healthcare Settings Only)
Each laboratory should establish and maintain its own
reference values. The values given here should be used
only as a guide.
______________________________________________________

Table A.1 Reference Values

Test Value (Normal)

HbA1c1 Normal (no diabetes): Less than 5.7%
Pre-diabetes: 5.7% to 6.4%
Diabetes: 6.5% or higher
Total Cholesterol <200 mg/dL
LDL <100 mg/dL
HDL >40 mg/dL (Males); >50 mg/dL (Females)
Triglycerides <150 mg/dL
Urine Albumin <20 mg/L (Spot Urine Collection)
Urine Creatinine N/A
UACR <30

______________________________________________________

References:
1. Crocker J. et al. Implementation of point-of-care testing in an
ambulatory practice of an academic medical center. Am J Clin
Pathol. 2014. 142:640-646.
Appendix A

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Instructions for Use Manual
A.4 Ordering Information

Nova Allegro Analyzer supplies and parts are available from

authorized Nova Allegro suppliers.

DESCRIPTION..........................................................................Part #
Allegro HbA1c Control Solution, L1,1 vial (0.5 mL).. 60159
Allegro HbA1c Control Solution, L2,1 vial (0.5 mL).. 60162
Allegro Lipid Control Solution, L1,1 Bottle (3 mL).... 60160
Allegro Lipid Control Solution, L2,1 Bottle (3 mL).... 60163
Allegro UACR Control Solution, L1,1 Bottle (3 mL)......60161
Allegro UACR Control Solution, L2,1 Bottle (3 mL)..... 60164
Allegro HbA1c Test Cartridge, 20 per pack.............. 59911
Allegro Lipids Test Cartridge, 20 per pack............... 59912
Allegro UACR Test Cartridge, 20 per pack.............. 59913
Allegro HbA1c Spare Capillary Packet.................... 59002
Allegro UACR Spare Capillary Packet..................... 59003
Allegro Lipids Spare Capillary Packet...................... 59007
Thermal Paper......................................................... 49200

A-6
 Appendix A
A.5 Warranty
Subject to the exclusions and upon the conditions specified below, Nova
Biomedical or the authorized Nova Biomedical distributor warrants that
he will correct free of all charges including labor, either by repair, or at
his election, by replacement, any part of an instrument which fails within
one (1) year after delivery to the customer because of defective material
or workmanship. This warranty does not include normal wear from use
and excludes: (A) Service or parts required for repair to damage caused
by accident, neglect, misuse, altering the Nova equipment, unfavorable
environmental conditions, electric current fluctuations, work performed
by any party other than an authorized Nova representative or any force
of nature; (B) Work which, in the sole and exclusive opinion of Nova,
is impractical to perform because of location, alterations in the Nova
equipment or connection of the Nova equipment to any other device; (C)
Specification changes; (D) Service required to parts in the system contacted
or otherwise affected by expendables or reagents not manufactured by Nova
which cause shortened life, erratic behavior, damage or poor analytical
performance; (E) Service required because of problems, which, in the sole
and exclusive opinion of Nova, have been caused by any unauthorized
third party; or (F) Instrument refurbishing for cosmetic purposes. All parts
replaced under the original warranty will be warranted only until the end of the original
instrument warranty. All requests for warranty replacement must be received by Nova
or their authorized distributor within thirty (30) days after the component failure. Nova
Biomedical reserves the right to change, alter, modify or improve any of its
instruments without any obligation to make corresponding changes to any
instrument previously sold or shipped. All service will be rendered during
Nova’s principal hours of operation. All requests for service outside Nova’s
principal hours of operation will be rendered at the prevailing weekend/
holiday rates after receipt of an authorized purchase order. Contact Nova
for specific information.
The above warranties are invalid if:
1. The date printed on the package label has been exceeded.
2. Non-Nova Biomedical reagents or controls are used, as follows:
Nova Biomedical will not be responsible for any warranties
on parts if these parts are used in conjunction with and are
adversely affected by reagents, controls, or other material not
manufactured by Nova but which contact or affect such parts.
Reagent formulations not manufactured by Nova Biomedical
may contain acids, concentrated salt solutions, and artificial
preservatives that have been shown to cause problems such
as shortened sensor/electrode life, sensor/electrode drift, erratic
Appendix A

analytical results, and inaccurate instrument performance.

THE FOREGOING OBLIGATIONS ARE IN LIEU OF ALL OTHER
OBLIGATIONS AND LIABILITIES INCLUDING NEGLIGENCE AND ALL
WARRANTIES, OF MERCHANTABILITY OR OTHERWISE, EXPRESSED
OR IMPLIED IN FACT BY LAW AND STATE OUR ENTIRE AND EXCLUSIVE
LIABILITY AND BUYER’S EXCLUSIVE REMEDY FOR ANY CLAIM
OF DAMAGES IN CONNECTION WITH THE SALE OR FURNISHING
OF GOODS OR PARTS, THEIR DESIGN, SUITABILITY FOR USE,
INSTALLATION OR OPERATION. NOVA BIOMEDICAL WILL IN NO
EVENT BE LIABLE FOR ANY SPECIAL OR CONSEQUENTIAL DAMAGES
WHATSOEVER, AND OUR LIABILITY UNDER NO CIRCUMSTANCES
WILL EXCEED THE CONTRACT PRICE FOR THE GOODS FOR WHICH
THE LIABILITY IS CLAIMED.

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A-8