Nova StatStrip Xpress ®

Glucose Hospital Meter

Instructions for Use Manual
 Table of Contents
Symbols.......................................................................................1
About This Manual.......................................................................2
Safety.......................................................................................3
Intended Use............................................................................6
Introduction..................................................................................9
CLIA Complexity......................................................................9
Clinical Utility..........................................................................14
The Sample............................................................................14
Interfering Substances...........................................................15
Operation Overview...............................................................16
Meter Sleep/Wakeup..............................................................17
Setup.........................................................................................19
Installing the Battery (Replacing)...........................................19
Set the Time...........................................................................21
Set Date Format.....................................................................24
Beeper On or Off....................................................................28
Testing: QC/Linearity/Proficiency/Blood Samples.....................30
When to Perform a QC Test...................................................30
StatStrip Glucose Control Solution .......................................31
 Table of Contents
Testing a Quality Control Solution..........................................33
Testing a Blood Sample.........................................................36
Testing a Linearity/Proficiency Solution.................................41
Reviewing Test Results..........................................................44
Deleting Stored Test Results..................................................45
Troubleshooting.........................................................................47
Battery Check........................................................................47
Error Codes............................................................................51
Appendix...................................................................................55
A.1 Specifications..................................................................56
A.2 Reference Values............................................................57
A.3 Glucose Methodology......................................................58
A.4 Quality Control Solution...................................................59
A.5 Chemistry Measurement.................................................59
A.6 Ordering Information........................................................60
A.7 Cleaning and Care...........................................................61
A.8 Results of CLIA Waiver Study..........................................63
Warranty....................................................................................75
 Symbols
The following are symbols that are used in this manual, on
insert sheets, and on the meter.
In vitro diagnostic medical
device Electronic Waste

EC REP Authorized Representative Catalog number

in the European Community

Product fulfills the requirements

Temperature limitation
of Directive 98/79 EC (IVDD)

Caution, consult accompanying

documents
Upper Limit of Temperature
Consult instructions for use

Biological risk Manufactured by

1
 About This Manual
This manual is for the Nova Biomedical StatStrip Xpress™
Glucose Hospital Meter.
Unit of Measure Information
The unit of measure of the StatStrip Xpress Glucose
Hospital Meter is factory set to the standards in the country
of use. The Meter either reports glucose results in mg/dL,
43404, or mmol/L, 44321, and can not be changed.
Separate Result screens and specifications are shown in the
Instructions for Use Manual for each unit of measure.
Throughout this manual:
NOTES provide important or helpful operating information.
CAUTIONS provide information that is important for instru-
ment protection.
WARNINGS provide information that is important for user
protection or about risk for inaccurate results.
2
 Safety
Personnel operating this meter must be proficient in the
operating and maintenance procedures of the meter. The
following safety procedures must be followed.
1. Read the safety and operating instructions before
operating the meter.
2. Retain the safety and operating instructions for
future reference.
3. Observe all warnings on the meter and in the
operating instructions.
4. Follow all operating and use instructions.
5. Place the meter away from heat sources.
6. The meter should be cleaned only as recommended
by the manufacturer.
7. The meter should be serviced by qualified service
personnel.
3
 Safety
Electrical Safety
1. Battery powered: 3-volt coin battery
Chemical and Biological Safety
1. Observe all precautionary information printed on the
original solution containers.
2. Operate the meter in the appropriate environment.
3. Dispose of all waste solutions according to standard
hospital procedures.
Disposal of Used Batteries for customers in Europe:
• This symbol on the battery label indicates that
the battery provided with the meter should not be
treated as household waste. To ensure the used
battery is treated properly, remove the used battery
from the meter and hand over the used battery to the

4
 Safety
applicable collection point for the recycling of electri-
cal and electronic equipment.
Disposal of Used Meters for customers in Europe:
• The meter may become infectious during the course
of use. Discard in accordance with local regulations
for biohazardous waste.
Environmental
• The operating temperature range for Meter operation: 59˚F
to 104˚F (15˚C to 40˚C)
• The relative humidity range for Meter operation: 10% to
90% non-condensing
• The maximum altitude for Meter operation: Up to
15,000 feet (4572 meters)

5
 Intended Use
Dimensions:
Height: 91.4mm (3.6in)
Width: 58.4mm (2.3in)
Depth: 22.9mm (0.9in)
Weight:
75 g (2.65 oz)

Intended Use
The Nova StatStrip Xpress Glucose Hospital Meter System
is intended for in vitro diagnostic use by health care profes-
sionals and for point-of-care usage in the quantitative deter-
mination of Glucose (Glu) in capillary, venous, and arterial
whole blood and neonatal capillary whole blood. It is not for
diagnosis of or screening for diabetes.

6
 Glucose Test Strip
LCD Display

mg/dL mmol/L

Left Arrow Button

Right Arrow Button

Mode Button
Result in mg/dL Result in mmol/L
Nova StatStrip Xpress Glucose Hospital Meter
7
 Glucose Beeper ON
Indicator
Blood or Control Glucose Test
Drop Indicator Result
Test Result
Low Battery mg/dL or mmol/L
Indicator Memory

AM or PM
Indicator
Date/Day Hour/Minute

Nova StatStrip Xpress Glucose Hospital Meter Screen

8
 Introduction
CLIA Complexity
This test is WAIVED for capillary, venous, and arterial whole
blood and neonatal capillary whole blood under the Clini-
cal Laboratory Improvements Amendments of 1988 (CLIA).
Laboratories with a Certificate of CLIA waiver can perform
this test in a waived setting and must follow the manufac-
turer’s instructions for performing the test. If a laboratory
modifies the test instructions, the test will no longer be
considered waived. (Refer to Appendix A.8, Results of CLIA
Waiver Study.)
This manual provides all necessary instructions for the
routine operation and maintenance of the Nova StatStrip
Xpress Glucose Hospital Meter. Please read this manual
carefully. It has been prepared to help you attain optimum
performance from your Meter.
9
 Introduction
WARNING: Healthcare professionals and others
using this system on multiple patients should be
aware that all products or objects that come into
contact with human blood should be handled as if ca-
pable of transmitting viral diseases, even after cleaning.
Precaution:
• Capillary blood glucose testing may not be appro-
priate for persons with decreased peripheral blood
flow, as it may not reflect the true physiological state.
Examples include, but are not limited to, severe hy-
potension, shock, hyperosmolar-hyperglycemia (with
or without ketosis) and severe dehydration.
This section introduces the meter and covers requirements,
tests performed, procedural limitations, clinical utility, and
sample handling.
10
 Introduction
• Prior to use, read the StatStrip Glucose Meter In-
structions for Use Manual.
• DO NOT reuse test strips. Strips are designed to be
disposed after a single use.
• Discard used test strips according to local regulations.
• Use only the Nova StatStrip Glucose Test Strips for
testing with the Nova StatStrip Glucose Meter.
• If test result is higher or lower than expected, run a
control solution test.
• Remove the test strip from the vial only when ready
to test.
• Do not use the test strip if the expiration date has
passed, for this may cause inaccurate results.
• Do not tamper with the test strip.

11
 Introduction
Additional Information for Healthcare Professionals
• The Nova StatStrip Glucose Test Strips are
calibrated against plasma.
• The Nova StatStrip Glucose Test Strips are used for
whole blood testing only.

12
 Introduction
The Nova StatStrip Xpress Glucose Hospital Meter is a
hand-held, battery-powered, in vitro diagnostic laboratory
instrument that works in conjunction with Nova Biomedical
glucose electrochemical test strips to measure glucose
in a whole blood sample, a Quality Control (QC) solution,
linearity, or proficiency solutions. The meter can store up to
400 patient and/or quality control test results. The user can
review all stored test results on screen. Functions and data
selection are accomplished by 3 push buttons. The meter
has a built-in beeper for audible alerts and prompts.

13
 Introduction
Clinical Utility
The Nova StatStrip Xpress Glucose Hospital Meter
System is intended for in vitro diagnostic use by
health care professionals and for Point-Of-Care
usage for the quantitative measurement of glucose
in capillary, venous, arterial, and neonate whole
blood. It is indicated for use in a clinical setting by
health care professionals as an aid to monitor the
effectiveness of diabetes control.

The Sample
• Capillary, venous, arterial, and neonate whole blood
• Plasma calibrated patient test results
• Sample size 1.2 µL
• Anticoagulants: sodium, lithium, and ammonium heparin
14
 Introduction
Interfering Substances
Glucose Interferences:
The Nova StatStrip Xpress Glucose Hospital Meter exhibits
no interference from the following substances up to the
following concentration levels:
Substances Conc Substances Conc
mg/dL(mmol/L) mg/dL(mmol/L)
Acetaminophen 10.0 (0.66) D(+) Maltose 240.0 (6.66)
Ascorbic Acid 10.0 (0.57) D(+) Maltotetraose 240.0 (3.6)
Bilirubin 15.0 (0.26) D(+) Maltotetriose 240.0 (4.76)
Cholesterol 500.0 (12.9) Methyl-Dopa 1.0 (0.042)
Creatinine 6.0 (0.53) Oxygen All Conc
Dopamine 10.0 (0.53) Salicylate 30.0 (1.87)
Ephedrine 0.9 (0.055) Tetracycline 30.0 (0.62)
D(+) Galactose 350.0 (19.4) Tolazamide 15.0 (0.48)
Hematocrit (RBC) 65% Tolbutamide 45.0 (1.67)
Ibuprofen 48.0 (2.33) Triglycerides 750.0 (8.78)
L-Dopa 100.0 (5.07) Uric Acid 20.0 (1.05)
15
 Introduction
Operation Overview
• To perform a test, the operator inserts a test strip
into the test strip port. Touch the end of the strip to a
drop of blood, QC solution, or linearity solution. The
results are obtained in 6 seconds.
• Prior to analysis, the operator may designate the test
sample as a quality control sample (level C1, C2, or C3).
• Test results are automatically stored into non-volatile
memory.
• The operator can recall and review all stored test
results.
• There are automatic electronic function checks to verify
proper meter operation.
• The meter stores up to 400 patient, quality control,
linearity, and proficiency test data.
16
 Introduction
• A coin-size battery provides power to operate the
meter. The battery provides sufficient power to
operate for approximately 600 tests. A low-battery
warning on the meter display alerts the operator to
change the battery. An auto sleep feature conserves
power when the meter is not in use.

Meter Sleep/Wakeup
The LCD display is turned off to conserve battery power
(sleep mode) after one minute of no activity. Keep-awake
activities includes:
• Pressing a button
• Inserting a test strip

17
 Introduction
If the meter goes into sleep mode, the following conditions
should be expected:
• If blanking occurs when a Patient Result screen is
displaying, the result is automatically saved.
• If the currently displayed screen is a Setup screen,
any unconfirmed input data or menu selection are
discarded prior to blanking.

Wakeup
To wake the meter, one of the following can be done:
• Press any button.
• Insert a strip.

18
 Setup
This section describes how to setup the Nova StatStrip
Xpress Glucose Hospital Meter. The operator can set the
meter for local time and date, have the beeper On or Off,
enable the sample counter, and set the date display format.

Installing the Battery (Replacing)

The meter is powered by a single 3V coin cell battery, 2450.
Install/Replace the battery as follows:
1. Remove the back battery cover on the meter.
2. Install the coin cell battery with
the + side facing up. (If replacing
the battery, remove the used bat-
tery and replace with a new one.)

19
 Setup
3. Replace the battery cover. All segments flash 3 times.
The software version and the default date and time will
appear for 3 seconds then the screen will go blank.
CAUTION: Upon installing the battery, the meter software
version is displayed for 3 seconds. Software versions
may be numeric (example 5.0); therefore, please exercise
caution to ensure the software version is not reported as a
glucose result.

20
 Setup
4. Go to setup to configure the meter.

Set the Time

1. Press the MODE button for longer than 3 seconds. The
meter if in Sleep Mode wakes up and enters the SETUP
Mode.

21
 Setup
2. Select the hour (flashing) format: either 12 Hr or 24 Hr. Press
the Right/Left Arrow buttons to toggle between the
2 time format options.
3. Press the MODE button to accept the Hour Format.
4. The meter displays the current time or the default time with
the hour digits flashing.
5. Press the Right/Left Arrow buttons to scroll from
1AM to 12PM (for 12 Hr Clock) or 0 to 23 (for 24 Hr Clock).
6. Press the MODE button to accept the displayed Hour
choice.
7. Next set the minutes (digits flashing). Press the Right/Left
Arrow buttons to scroll from 00 to 59 minutes.

22
 Setup

8. Press the MODE button to accept the displayed Min-

utes choice.

23
 Setup
Set Date Format
1. Next set the date format. The display is 1-31 2007 or
31.01.2007.
2. You can choose to have the date displayed as
DD.MM or MM-DD. Press the Right/Left Arrow
buttons to toggle between DD.MM or MM-DD.

3. Press the MODE button to accept the displayed

Date Format.
24
 Setup
4. The year should be flashing. Press the Right/Left
Arrow buttons to select the current year.

5. Press the MODE button to accept the displayed

Year.

25
 Setup
6. The month should be flashing. Press the Right/
Left Arrow buttons to scroll through the 12
months (1 to 12).

7. Press the MODE button to accept the displayed

Month.

26
 Setup
8. The day should be flashing. Press the Right/Left Ar-
row buttons to scroll through the days of the
month.

9. Press the MODE button to scroll the displayed

Day.

27
 Setup
Beeper On or Off
1. Press the Right/Left Arrow buttons to toggle
between Beeper ON or OFF (flashing).

2. Press the MODE button to accept the displayed

ON or OFF.

28
 Setup
End is displayed with the entered date and time. Press the
Mode button for 1.5 seconds to exit Setup or the meter will
time out in 1 minute.

29
 Testing: QC/Linearity/Proficiency/Blood Samples
This section describes how to run QC (Quality Control),
Linearity Solution, Proficiency Solution, and blood samples.

When to Perform a QC Test

The Nova StatStrip Xpress Glucose Hospital Meter includes
several quality control mechanisms that detect errors due to
system failures and operator performance. External controls
materials are available from Nova Biomedical for verifying
the integrity of the Nova StatStrip Xpress Glucose Hospital
Meter. These StatStrip Glucose Control Solutions consist of 3
levels of ready-to-use liquid controls. They are formulated at
clinically relevant levels. The controls can be used as part of a
laboratory quality control program. Run the controls according
to the procedure in Section 2.3 Quality Control Test.

30
 Testing a Quality Control Solution
StatStrip Glucose Control Solution
Read the StatStrip Glucose Control Solution pack-
age insert sheet for complete instructions, indications,
precautions, and limitations of the system.

Only the Nova StatStrip Glucose Control Solutions are rec-

ommended for use with the Nova StatStrip Xpress Glucose
Meter and the Nova StatStrip Glucose Test Strips. Ranges
for the Nova StatStrip Xpress Glucose Meter using other
commercially available glucose controls have not been
established and may give erroneous results. Run 2 differ-
ent levels of the StatStrip Glucose Control Solutions during
each 24 hours of testing prior to testing of patient speci-
mens and under the following circumstances:
31
 Testing a Quality Control Solution
• Each new operator
• Before using the StatStrip Meter for the first time
• If a patient test has been repeated and the blood
glucose results are still lower or higher than
expected
• If there are other indications that the system is not
working properly
• Whenever problems (storage, operator, instrument)
are identified or anytime there is a concern the
accuracy of the meter may have been affected by
rough handling (such as dropping the meter).
• As required by the institution’s quality control policy
or local regulatory requirements

32
 Testing a Quality Control Solution
Good Laboratory Practice principles suggest that external
controls must be run whenever the laboratory director has any
question about the test system integrity or operator technique.
This section describes how to run QC (Quality Control),
Linearity Solution, Proficiency Solution, and blood samples.
Testing a Quality Control Solution
1. Insert a test strip into the meter. Verify that all segments
of the screen display. If the display is incomplete, discon-
tinue use for diagnostic testing. Then
a flashing blood drop will display.
NOTE: If strip is removed before
the test starts or is not
used for over 2 minutes,
the screen will go blank.
33
 Testing a Quality Control Solution
2. Identify the sample as a Control; use the Left or
Right button to find the desired control level: C1, C2,
or C3.

3. Touch the end of the test strip to a drop of control

solution until the test strip fills and the meter beeps.
NOTE: A quick beep sounds when sufficient control
solution has been added to the test strip.

34
 Testing a Quality Control Solution
4. Glucose quality control test results are available on-
screen in 6 seconds.

Result Displayed Result

in mg/dL Displayed in
mmol/L

5. There is one long beep when the results are ready.

There are 3 short beeps if test results are outside the
measurement range of the test strip.

35
 Testing a Blood Sample
NOTE: Do not test patient samples until control solution
test results are within expected range.
1. Insert a test strip into the meter. Verify that all
segments of the screen display. If the display is
incomplete, discontinue use for diagnostic testing.
Then a flashing blood drop will display.

NOTE: If strip is re-

moved before the test
starts or is not used
for over 2 minutes,
the screen will go
blank.

36
 Testing a Blood Sample
2. Wash patient's hand with
water then dry thoroughly.
Alternatively, use alcohol
pads to clean area; dry
thoroughly after cleaning.

3. Holding hand down-

ward, massage finger
with thumb toward tip to
stimulate blood flow.

4. Use a lancet to puncture the finger.

37
 Testing a Blood Sample
5. Squeeze the finger to
form a drop of blood.

6. When the blood drop

appears, touch the end of
the test strip to the blood
drop until the test strip fills
and the meter beeps.

7. Glucose test results are

available on-screen in 6
seconds.

38
 Testing a Blood Sample

Result in mg/dL Result in mmol/L

8. There is one long beep when the results are ready.

There are 3 short beeps if test results are outside
the range of the test strip.

39
 Testing a Blood Sample
If result is LO (less than the measurement range) or
Hi (greater than the measurement range) repeat the
test.

HI in mg/dL LO in mmol/L

NOTE: Test results are automatically saved. If no activity

for 1 minute, the meter will time-out: screen goes blank.

40
 Testing a Linearity/Proficiency Solution
For CLIA Moderate Settings only: This section describes how to
perform Linearity tests with the StatStrip Xpress Glucose Hospital
Meter. There are 5 levels in the StatStrip Glucose Linearity kit.
Refer to the StatStrip Linearity Kit package insert
sheet for complete instructions, indications, precau-
tions, and limitations of the system.
1. Insert a test strip into the meter. Verify that all seg-
ments of the screen display. If the display is incom-
plete, discontinue use
for diagnostic testing.
Then a flashing blood
drop will display.

41
 Testing a Linearity/Proficiency Solution
2. Touch the end of the test strip to a drop of linearity
solution or proficiency solution until the test strip fills
and the meter beeps.
NOTE: LinearitylProficiency test results are stored in
memory as a blood sample.
NOTE: A quick beep sounds when sufficient linearity/
proficiency solution has been added to the test strip.

3. Linearity or proficiency test results are available on-

screen in 6 seconds.

42
 Testing a Linearity/Proficiency Solution

Result in mg/dL Result in mmol/L

4. There is one long beep when the results are ready.

There are 3 short beeps if test results are outside the
measurement range of the test strip.

43
 Reviewing Test Results
The meter is able to store up to 400 test results.
1. To review test results, press the Mode button once
for less than 3 seconds.
2. If there are no results in memory, the screen displays
- - - on the mem (memory) screen.
If there are tests saved, the most recent test is
displayed first.
3. Press the left arrow button to scroll backward thru
results. Press the right arrow button to scroll forward
thru results.
4. If you scroll past the first or last stored result, the
screen displays END.
5. After 400 test results, the new result will override the
oldest result in memory.

44
 Deleting Stored Test Results
You can delete all stored test and QC results. Proceed as
follows to delete all results:
1. Press the Mode button once to display the number
of stored test results.
2. Press the Right and Left arrow button simultaneously
for longer than 3 seconds.
3. The screen displays the number of samples in memory
with delete flashing at the bottom of the screen.

Number of
Delete Samples in
Memory

45
 Deleting Stored Test Results
4. When the Screen displays dELEtE (flashing), press
the left and right buttons simultaneously for greater
than 3 seconds. All results are deleted. The screen
will display OK and dELEtEd as shown below.
5. To exit without deleting results. press the MODE
button once.

46
 Troubleshooting
This section describes Battery status, Error Codes, and Ac-
tions for the Nova StatStrip Xpress Glucose Hospital Meter.

Battery Check
The battery provides sufficient power to operate for
approximately 600 tests. A battery low warning will alert the
user to replace the battery. Test results are stored in non-
volatile memory to prevent test result loss.

47
 Troubleshooting
How to view the battery status of the meter:
• Insert a test strip to the meter when it is turned off.
• All segments will display for 2 seconds.
• Battery is OK: a flashing blood drop appears at the
lower left corner of the screen.
Continue with testing as usual.

Flashing Blood
Drop

48
 Troubleshooting
• Battery is Low: a flashing blood drop and battery
icon appear at the lower left corner of the screen:
battery charge sufficient for up to 10 tests.
Continue with testing as usual. Battery icon remains
on the screen.

Battery Icon
Flashing Blood Drop

49
 Troubleshooting
• Battery is very Low: battery icon at the lower left
corner of the screen: battery charge insufficient for
testing.
Meter will not operate and battery icon disappears
when the test strip is removed. Replace the battery.

Battery Icon CAUTION: Attempts to perform

glucose testing with a low battery
could result in the software rebooting.
Upon rebooting, the software version
is displayed for 3 seconds. Software
versions may be numeric (example
5.0); therefore, please exercise
caution to ensure the software version
is not reported as a glucose result.
50
 Troubleshooting
Error Codes
There are 8 Error Codes to inform you of problems with the
meter. This section provides action procedures when these
Error Codes are displayed. The error code displays after the
test strip is inserted and the all segments screen displays for
2 seconds. If the beeper is enabled, there are also 3 quick
beeps. Then the Error Code is displayed on the screen.

E0 Software Error
A software error has been detected.
Action: Perform the test again. If you
get the same error again, remove and
reseat the battery. If the error continues,
call Nova Technical Support.

51
 Troubleshooting
E1 System Hardware Error
A system hardware error has been detected.
Action: Perform the test again. If
you get the same error, call
Nova Technical Support.

E2 Operating Temperature Error

The Meter temperature is outside of the range
for testing.
Action: Move the meter to an area where
the temperature is acceptable (59°-104°F
or 15°-40°C), allow meter to adjust to the
temperature. Repeat the test.

52
 Troubleshooting
E3 Used Strip Error
The test strip was previously used.
Action: Repeat the test with a new test
strip. If the error persists, perform the
test using an alternate test strip vial or
alternate method.

E4 Short Sample Error

An insufficient sample volume (Control or
blood) was drawn into the test strip.
Action: Repeat the test with a new test
strip. If the error persists, perform the
test using an alternate test strip vial or
alternate method.

53
 Troubleshooting
E5 Strip Not Recognized Error
The test strip is not recognized.
Action: Repeat the test with a new test
strip. If the error persists, perform the
test using an alternate test strip vial or
alternate method.

E8 Bad Strip Error

The test strip is defective or bad.
Action: Repeat the test with a new test
strip. If the error persists, perform the
test using an alternate test strip vial or
alternate method.

54
 Troubleshooting
E9 Bad Sample Error
A problem was detected with the sample.
Action: Repeat the test with a new test
strip. If the error persists, perform the
test using an alternate test strip vial or
alternate method.

Appendix

The Appendix includes solution and reagent specifications,

accuracy and precision, consumable list, reference informa-
tion, and warranty.

55
 Appendix
A.1 Specifications
Tests Measured Blood Glucose
(referred to Plasma Values)
Glucose Methodology Enzyme, Amperometric
Glucose Test Results mg/dL, mmol/L
Sample Type Whole blood
Glucose Test Range 10 to 600 mg/dL
0.6 to 33.3 mmol/L
Test Time 6 seconds
Test Strip Volumes 1.2 µL
Memory storage 400 Tests
Battery Life (nominal) 600 Tests
Battery Type 2450 3V coin cell
Data Cable Serial or USB

56
 Appendix
Operating Ranges:
Temperature 59° to 104°F (15° to 40°C)
Humidity 10% to 90% relative humidity
Altitude 15,000 ft (4572 meters)
Hematocrit 20% to 65%
Weight 2.65 oz (75 g)
Size 3.6x2.3x0.9 in(91.4x58.4x22.9 mm)
A.2 Reference Values
Each laboratory should establish and maintain its own reference
value. The value given here should be used only as a guide.
Fasting Glucose1 65 - 95 mg/dL (3.6 - 5.3 mmol/L)
1. Burtis, Carl A. and Ashwood, Edward R., ed. 1994. Tietz
Textbook of Clinical Chemistry. Philadelphia, PA: W. B.
Saunders Co.
57
 Appendix
A.3 Glucose Methodology
The glucose measurement is based on the following
methodology:

1. Glucose + Enzymes(oxidized form) –––>

Gluconic Acid + Enzymes(reduced form)

2. Enzymes(reduced form) + Ferricyanide ––>

Enzymes(oxidized form) + Ferrocyanide

-e-
3. Ferrocyanide ————— > Ferricyanide
Electrode
The current generated at the electrode is proportional to the
glucose concentration of the sample.

58
 Appendix
A.4 Quality Control Solution
QC Solutions Levels 1, 2, 3
Linearity Solutions Levels 1, 2, 3, 4, 5

A.5 Chemistry Measurement

The typical imprecision for glucose both for within-run and
day-to-day

Glucose Levels Glucose Levels CV%

(mg/dL) (mmol/L)
50 2.8 8%
150 8.3 6%
400 22.2 4%
600 33.3 4%

59
 Appendix
A.6 Ordering Information
Supplies and parts for the Nova StatStrip Xpress Glucose
Hospital Meter are available from Nova Biomedical.
DESCRIPTION........................................................
Instructions for Use Manual.................................... 43306
Quick Reference Guide........................................... 44398
StatStrip Xpress Glucose Meter (mg/dL)................ 43404
StatStrip Xpress Glucose Meter (mmol/L).............. 44321
StatStrip Glucose Test Strips (1800), 72 vials, 50 per vial.42214
Glucose Control Solution, Level 1........................... 41741
Glucose Control Solution, Level 2........................... 41742
Glucose Control Solution, Level 3........................... 41743
Linearity Solution, Levels 1-5.................................. 42173
Battery (DL2450)..................................................... 41221
60
 Appendix
A.7 Cleaning and Care
The meters should never be immersed in any cleaning
agent. Always apply the cleaning agent to a soft cloth to
wipe the meter surface. Once complete, immediately dry
thoroughly. When cleaning the meter, please follow the
guidelines listed below:
• Dilute Bleach. A 10% solution of household bleach
(Sodium Hypochlorite) may be used.
• 70% Isopropyl (rubbing) Alcohol may be used.
• Commercial surface decontamination preparations
that are approved for use by your facility can be
used. Apply to a small test area first to ensure
surface finish integrity.
• Avoid harsh solvents such as benzene and strong
acids.
61
 Appendix
CAUTION: DO NOT immerse the meter or hold the
meter under running water. DO NOT spray the meter with
a disinfectant solution.
CAUTION: Do Not attempt to open the meter to make any
repairs. Your warranty and all claims will be void! Only
Nova Biomedical authorized service personnel can repair
the meter. Call Nova Biomedical or an authorized dealer if
the meter needs to be repaired or checked.

62
Appendix
A.8 Results of CLIA Waiver Study
Clinical Site descriptions:
A clinical study was conducted at 4 sites located in 2
regions of the United States. Three sites in Florida (Site1:
Medical Surgical unit; Site2: Cardiac, Pediatric, Oncol-
ogy unit; and Site3: Progressive care unit), and Northeast
region (Site4: Nova Biomedical, Waltham, MA). There were
a total of 24 operators distributed as follows; site1 through
site 4 had 3, 4, 5, and 12 operators, respectively. The study
involved running 525 specimens (110 subjects; 196 ve-
nous; 15 spiked samples; 171 arterial; and 33 low capillary
samples) across over 15 days by untrained intended opera-
tors. In addition, 100 neonatal capillary samples (includ-
ing 3 spiked samples) were collected from the St. Louis
Children’s hospital, St. Louis, MO, and compared to Vitros
(Johnson & Johnson).
63
 Results of CLIA Waiver Study (continued)
The comparative methods used were Dade RxLfor venous
and arterial whole blood and Yellow Springs Instrument
(YSI) model 2300 STAT Plus for capillary whole blood. Dis-
carded whole blood samples ran by hospital personnel and
then immediately centrifuged by a health care professional
to obtain a plasma sample to be analyzed on a central labo-
ratory chemistry analyzer (Dade RxL).
The study was intended to demonstrate that after reading
only the test instructions, untrained intended operators were
able to easily perform glucose measurements with the Nova
StatStrip Xpress that were as accurate as those obtained by
trained operators using the comparative methods. The crite-
ria for success for accuracy required that at least 95% of the
results fall within the allowable total error (ATE) zone, defined
as ± 15 mg/dL of the comparative method for glucose levels
≤75 mg/dL and within ± 15% for glucose levels > 75 mg/dL.
64
 Results of CLIA Waiver Study (continued)
The results of the study for venous and arterial samples
were following:
Range of Total number Number of Percent of
Dade values of samples samples samples
(mg/dL) within of ATE within of ATE
17 to 97 169 169 100%
97.1 to 114 56 56 100%
114.1 to 622 142 138 97.2%
17 to 622 367 363 98.9%

The percentage of the arterial and venous samples over the

entire range that fall within the ATE zone was 98.9% (363/367)
with a lower one-sided 95% confidence bound of 97.6%. In the
study, none samples were in the LER zone (0% with an upper
bound of 95% confidence interval of 0.7%).
65
 Results of CLIA Waiver Study (continued)
The scatter plot of the study results for arterial and venous sam-
ples with ATE and LER zones is presented by the figure below:

66
 Results of CLIA Waiver Study (continued)
The descriptive statistics of the differences between Dade
glucose and Nova StatStrip results of arterial and venous
samples are presented by the table below:

Range of Average 2.5th percen- 97.5th percen-

Dade values Difference tile of relative tile of relative
(mg/dL) differences differences
17 to 75 -0.45 mg/dL -7.7 mg/dL 6.7 mg/dL
75.1 to 97 -0.1 % -11.5 % 11.38 %
97.1 to 114 0.95 % -10.55 % 9.65 %
114.1 to 622 -1.56% -14.52 % 10.87 %

67
 Results of CLIA Waiver Study (continued)
The results of the study for capillary samples were following:

Range of Total Number of Percent of

YSI values number of samples samples
(mg/dL) samples within of within of
ATE ATE
<75 32 32 100%
75 - 97 51 48 94.1%
97.1 to 114 48 47 97.9%
> 114 27 26 96.3%
Total 158 153 96.8%

68
 Results of CLIA Waiver Study (continued)
The percentage of the capillary samples over the entire
range that fall within the ATE zone was 96.8% (153/158)
with a lower one-sided 95% confidence bound of 93.6%.
In the study, no samples
were in the LER zone (0%
with an upper bound of
95% confidence interval
of 1.7%).

The scatter plot of the

study results for capillary
samples with ATE and
LER zones is presented
by the figure:

69
 Results of CLIA Waiver Study (continued)
The descriptive statistics of the differences between YSI
glucose and Nova StatStrip results of capillary samples are
presented by the table below:
Range of Average 2.5th 97.5th
Dade values Difference percentile percentile
(mg/dL) of relative of relative
differences differences
31 to 75 1.49 mg/dL -3 mg/dL* 5.8 mg/dL
75.1 to 97 1.36 % -15.77 % 13.81 %
97.1 to 114 1.55 % -10.9 % 11.89 %
114.1 to 585 -0.39% -14.53 %* 10.14 %

*Due to small sample size, the minimum was used.

70
 Results of CLIA Waiver Study (continued)
Please note that the upper one-sided 95% confidence
bound for capillary was 1.7% due to small sample size.

The results of the study for neonatal capillary samples were

following:
Range of Vi- Total Number of Percent of
tros values number of samples samples
(mg/dL) samples within of ATE within of ATE
<75 65 65 100%
75 - 97 24 24 100%
97.1 to 114 7 7 100%
> 114 4 4 100%
Total 100 100 100%

71
 Results of CLIA Waiver Study (continued)
The percentage of the neonatal capillary samples over
the entire range that fall within the ATE zone was 100%
(100/100) with a lower one-sided 95% confidence bound
(score method) of 97.4%. In the study, no samples were in
the LER zone (0% with an upper one-sided 95% confidence
bound of 2.6%).

72
 Results of CLIA Waiver Study (continued)
The scatter plot of
the study results for
neonatal capillary
samples with ATE
and LER zones is
presented by the
figure:

The descriptive
statistics of the dif-
ferences between Vitros (Johnson & Johnson) glucose and
Nova StatStrip results of neonatal capillary samples are
presented by the next table:
73
 Results of CLIA Waiver Study (continued)
Range of Average Dif- 2.5th percen- 97.5th percen-
Dade values ference tile of relative tile of relative
(mg/dL) differences differences
18 to 75 -3 mg/dL -12.75 mg/dL 5 mg/dL
75.1 to 97 -1.3 % -14.9 %* 9.1 %
97.1 to 114 -0.4 % -4.4 %* 6.1 %**
114.1 to 396 -1.1 % -3.6 %* 2.2 %**

* Due to small sample size, the minimum was used.

** Due to small sample size, the maximum was used.
Please note that the upper one-sided 95% confidence
bound for neonatal capillary samples was 2.6% due to small
sample size.
74
 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 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 of
damage caused by accident, neglect, misuse, altering the Nova equipment, un-
favorable 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 connec-
tion 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

75
 Warranty
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.
Contact Nova for specific information.
The following exceptions apply:
• Consumable items, including quality control solutions, are warranted to be
free of defects until the end of the expiration date or 90 days after the date
opened. Glucose Test Strips are warranted to be free of defects until the end
of the expiration date or 180 days after the date opened. The item must be
placed into service prior to the expiration date printed on the packaging.
• Freight is paid by the customer.
This warranty is invalid under the following conditions:
1. The date printed on the package label has been exceeded.
2. Non-Nova Biomedical reagents or controls are used, as follows: Nova Bio-
medical will not be responsible for any warranty on Nova StatStrip Xpress
Glucose Hospital Meter if 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.
76
 Warranty
THE FOREGOING OBLIGATIONS ARE IN LIEU OF ALL OTHER OBLIGA-
TIONS AND LIABILITIES INCLUDING NEGLIGENCE AND ALL WAR-
RANTIES, 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, INSTAL-
LATION OR OPERATION. NOVA BIOMEDICAL WILL IN NO EVENT BE
LIABLE FOR ANY SPECIAL OR CONSEQUENTIAL DAMAGES WHAT-
SOEVER, AND OUR LIABILITY UNDER NO CIRCUMSTANCES WILL
EXCEED THE CONTRACT PRICE FOR THE GOODS FOR WHICH THE
LIABILITY IS CLAIMED.

77
78
 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

For technical assistance outside the United States, call your local Nova subsidiary or authorized
distributor.

Nova Biomedical Canada, Ltd. Nova Biomedical UK Nova Biomedical GesmbH

17 - 2900 Argentia Road Innovation House Laxenburgerstrasse 33/6
Mississauga, Ontario L5N 7X9 Aston Lane South, Runcorn A-1100 Vienna
Canada Cheshire, WA7 3FY Austria
Tel: 1 800 263 5999 UK Tel: + 43 1 603 09700
1 905 567 7700 Tel: + 44 1928 704040

Nova Biomedical France Nova Biomedical GmbH Nova Biomedical KK

Parc Technopolis - Bât. Sigma Messenhauser Str. 42 B-3F Omori Bellport
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91940 Germany Tokyo 140-0013
France Tel: + 49 6074 8448 0 Japan
Tel: + 33 1 64 86 11 74 Tel: + (813) 5471-5461
Nova Biomedical Corporation Telephone: 1-800-458-5813
200 Prospect Street 1-781-894-0800
Waltham, MA 02454-9141 Fax: 1-781-893-6998
U.S.A. Web: www.novabiomedical.com

U.S. Patent Nos. 6,258,229; 6,837,976; and 6,942,770

CA 2,375,089; 2,375,092
Made in the USA by Nova Biomedical Corporation
StatStrip Xpress® is a registered trademark of Nova Biomedical.
Copyright 2012 Nova Biomedical Corporation

43306F 12.2012