NOVA BIOMEDICAL Nova StatSensor Xpress-i Manual

Nova StatSensor® Xpress-i™
Creatinine Hospital Meter
Instructions for Use Manual
For Export Only

Table of Contents






























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Table of Contents

1
Symbols
The following are symbols that are used in this manual, on
insert sheets, and on the meter.
 Invitro diagnostic medical
device
REP
EC
 Authorized Representative
in the European Community
Product fullls the requirements
of Directive 98/79 EC (IVDD)
Caution, consult accompanying
documents
Consult instructions for use
Biological risk
Electronic Waste
Catalog number
90
Discard 90 days after opening
Temperature limitation
Upper Limit of Temperature
Manufactured by

2
About This Manual
This manual is for the Nova Biomedical StatSensor®
Xpress-i™ Creatinine Meter.
Unit of Measure Information
The unit of measure of the Nova StatSensor Xpress-i
Creatinine Meter is factory set to the standards in the
country of use. The Meter either reports creatinine results in
mg/dL or µmol/L and can not be changed. Separate Result
screens and specications 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.

3
Safety
Personnel operating this meter must be procient 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.

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

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: 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)
Safety

6
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 StatSensor Xpress-i Creatinine Meter System
is intended for invitro diagnostic use by health care pro-
fessionals and for point-of-care usage in the quantitative
determination of Creatinine (Creat ) in capillary, venous,
and arterial whole blood. Creatinine measurements are
used in the diagnosis and treatment of renal diseases and
in monitoring renal dialysis. Not for use in neonates.
Intended Use

7
Nova StatSensor Xpress-i Creatinine Meter
Left Arrow Button
Mode Button
Right Arrow Button
Creatinine Test Strip
mg/dL µmol/L
Result in mg/dL Result in µmol/L
Strip Ejector Button

8
Creatinine
Low Battery
Indicator
Blood or Control
Drop Indicator
Test Result
mg/dL or µmol/L
Beeper ON
Indicator
Creatinine Test
Result
AM or PM
Indicator
Date/Day Hour/Minute
Nova StatSensor Xpress-i Creatinine Meter Screen
Memory

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.
This section introduces the meter and covers requirements,
tests performed, procedural limitations, clinical utility, and
sample handling.
• Prior to use, read the StatSensor Xpress-i Creatinine
Meter Instructions for Use Manual.
• DO NOT reuse test strips. Strips are designed to be
disposed after a single use.

10
• Discard used test strips according to local regulations.
• Use only the Nova StatSensor-i Creatinine Test Strips
for testing with the Nova StatSensor Xpress-i Creati-
nine 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
Additional Information for Healthcare Professionals
• The Nova StatSensor-i Creatinine Test Strips are
calibrated against plasma.
• The Nova StatSensor-i Creatinine Test Strips are
used for whole blood testing only.
Introduction

12
The Nova StatSensor Xpress-i Creatinine Meter is a
hand-held, battery-powered, invitro diagnostic laboratory
instrument that works in conjunction with Nova Biomedical
creatinine electrochemical test strips to measure creatinine
in a whole blood sample, a Quality Control (QC) solution,
linearity, or prociency 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

13
Clinical Utility
The StatSensor Xpress-iCreatinine Meter is
intended for invitro diagnostic use by health care
professionals and for Point-Of-Care usage for the
quantitative measurement of creatinine in capillary,
venous, and arterial whole blood. Creatinine
measurements are used in the diagnosis and
treatment of renal diseases and in monitoring renal
dialysis. Not for use in neonates.
The Sample
• Capillary, venous, and arterial whole blood
• Plasma calibrated patient test results
• Sample size 1.2 µL
• Anticoagulants: sodium, lithium, and ammonium heparin

14
Interfering Substances
Creatinine Interferences:
The Nova StatSensor Xpress-i Creatinine Meter exhibits
no interference from the following substances up to the
following concentration levels:
Substances Conc
mg/dL(mmol/L)
Acetaminophen 10.0 (0.66)
Ascorbic Acid 3.5 (0.20)
Bilirubin 15.0 (0.26)
Cholesterol 1000.0 (25.8)
Creatine 4.0 (0.35)
Dopamine 10.0 (0.53)
Glucose 500.0 (27.8)
Hematocrit (RBC) 30%-60%
Heparin 120 units/dL
L-Dopa 300.0 (15.21)
Substances Conc
mg/dL(mmol/L)
D(+) Maltose Mono 100.0
Oxygen All Conc
Salicylate 30.0 (1.87)
Triglycerides 1000.0 (8.78)
Uric Acid 20.0 (11.4)
Introduction

15
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 30 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 prociency test data.
Introduction

16
• A coin-size battery provides power to operate the
meter. The battery provides sufcient 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