NOVA BIOMEDICAL StatStrip Xpress-i Manual
Nova StatStrip Xpress®-i
Glucose and ß-Ketone Hospital Meter
Instructions for Use Manual
For Export Only
Table of Contents
Table of Contents
1
Symbols
The following are symbols that are used in this manual, on
insert sheets, and on the meter.
Invitro diagnostic medical
device
REP
EC
Authorized Representative
in the European Community
Product fullls the requirements
of Directive 98/79 EC (IVDD)
Caution, consult accompanying
documents
Consult instructions for use
Biological risk
Electronic Waste
Catalog number
Temperature limitation
Upper Limit of Temperature
Manufactured by
2
About This Manual
This manual is for the Nova Biomedical StatStrip Xpress-i
Glucose and ß-Ketone Hospital Meter.
Unit of Measure Disclaimer
The StatStrip Xpress-i Glucose and ß-Ketone Hospital
Meter is factory set to report glucose results in mg/dL or
mmol/L and ketone results in mmol/L.
Throughout this manual:
NOTESprovideimportantorhelpfuloperatinginformation.
CAUTIONSprovideinformationthatisimportantforinstru-
mentprotection.
WARNINGSprovideinformationthatisimportantforuser
protectionoraboutriskforinaccurateresults.
3
Safety
Personnel operating this meter must be procient 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 qualied service
personnel.
4
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
Safety
5
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: 5˚C
to 40˚C (41˚F to 104˚F)
• 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)
Safety
6
Nova StatStrip Xpress-i Glucose and ß-Ketone Hospital Meter
LCD Display
Left Arrow
Button
Mode Button
Right Arrow
Button
Test Strip
Results
mmol/L
Glucose Result Ketone Result
Results
mg/dL
7
Glucose
Low Battery
Indicator
Blood or Control
Drop Indicator
Test Result
mmol/L
Beeper ON
Indicator
Glucose Test
Result
AM or PM
Indicator
Date/Day Hour/Minute
Nova StatStrip Xpress-i Glucose and ß-Ketone Hospital Meter Screen
Memory
Ketone
8
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-i Glucose and ß-Ketone Hos-
pital Meter System is intended for invitro diagnostic use
by health care professionals and for point-of-care usage
in the quantitative measurement of Glucose (Glu) in fresh
capillary, venous, arterial, and neonate whole blood and the
quantitative determination of ß-Ketone (Ket) in fresh capil-
lary and venous whole blood samples. It is not for diagnosis
or screening for diabetes. It is intended for Export Only.
Intended Use
9
Introduction
This manual provides all necessary instructions for the
routine operation and maintenance of the Nova StatStrip
Xpress-i Glucose and ß-Ketone Hospital Meter. Please read
this manual carefully. It has been prepared to help you at-
tain optimum performance from your Meter.
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 capa-
ble of transmitting viral diseases, even after cleaning.
CAUTION:Capillarybloodglucosetestingmaynotbeap-
propriateforpersonswithdecreasedperipheralbloodow,asit
maynotreectthetruephysiologicalstate.Examplesinclude,
butarenotlimitedto,severehypotension,shock,hyperosmolar-
hyperglycemia(withorwithoutketosis)andseveredehydration.
10
This section introduces the meter and covers requirements,
tests performed, procedural limitations, clinical utility, and
sample handling.
The Nova StatStrip Xpress-i Glucose and ß-Ketone Hospital
Meter is a hand-held, battery-powered, invitro diagnostic
laboratory instrument that works in conjunction with Nova
Biomedical electrochemical test strips to measure glucose
and ketone in a whole blood sample, a Quality Control (QC)
solution, linearity, or prociency 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.
Introduction
11
Introduction
Clinical Utility
The measurement of glucose is used in the
monitoring of carbohydrate metabolism disturbances
including diabetes mellitus, and idiopathic
hypoglycemia, and of pancreatic islet cell carcinoma.
Ref. 1. Burtis, Carl A. and Ashwood, Edward R., ed.
1999. TietzTextbookofClinicalChemistry. Philadel-
phia, PA: W. B. Saunders Co.
The Sample
• Whole blood
• Plasma calibrated patient test results
• Sample size 1.2 µL
12
Interfering Substances
Glucose Interferences:
The Nova StatStrip Xpress-i Glucose and ß-Ketone Hospital
Meter exhibits no interference for glucose from the following
substances up to the following concentration levels:
Substances Conc
mg/dL(mmol/L)
Acetaminophen 10.0 (0.66)
Ascorbic Acid 10.0 (0.57)
Bilirubin 15.0 (0.26)
Cholesterol 500.0 (12.9)
Creatinine 6.0 (0.53)
Dopamine 10.0 (0.53)
Ephedrine 0.9 (0.055)
D(+) Galactose 350.0 (19.4)
Hematocrit (RBC) 65%
Ibuprofen 48.0 (2.33)
L-Dopa 100.0 (5.07)
Introduction
Substances Conc
mg/dL(mmol/L)
D(+) Maltose 240.0 (6.66)
D(+) Maltotetraose 240.0 (3.6)
D(+) Maltotetriose 240.0 (4.76)
Methyl-Dopa 1.0 (0.042)
Oxygen All Conc
Salicylate 30.0 (1.87)
Tetracycline 30.0 (0.62)
Tolazamide 15.0 (0.48)
Tolbutamide 45.0 (1.67)
Triglycerides 750.0 (8.78)
Uric Acid 20.0 (1.05)
13
Ketone Interferences:
The Nova StatStrip Xpress-i Glucose and ß-Ketone Hospital
Meter exhibits no interference for ß-Ketone from the
following substances up to the following concentration levels:
Substances Concentration
mg/dL(mmol/L)
Acetaminophen 20.0 (1.32)
Acetone 10 (1.72)
Aceteactate 10 (0.93)
Ascorbic Acid 20 (1.14)
Bilirubin 10 (0.18)
Captopril 10 (0.46)
Cholesterol 500 (12.9)
Creatinine 6 (0.53)
Dopamine 10 (0.53)
Ephedrine 0.9 (0.035)
Glucose 900 (50.0)
Introduction
Substances Concentration
mg/dL(mmol/L)
Ibuprofen 48 (2.33)
L-Dopa 10 (0.51)
Methyl-Dopa 1 (0.042)
N-Acetyl-L-Cysteine 10 (0.61)
Tetracycline 30 (0.62)
Tolazamide 15 (0.48)
Tolbutamide 45 (1.67)
Triglycerides 75 (0.88)
Salicylate 30 (1.87)
Uric Acid 20 (1.05)
14
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 for glucose and 10
seconds for ketone.
• 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.
Introduction
15
Introduction
• The meter stores up to 400 patient, quality control,
linearity, and prociency test data.
• A coin-size battery provides power to operate the
meter. The battery provides sufcient 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
16
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 unconrmed 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.
Introduction
Table of contents
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