NOVA BIOMEDICAL Stat Profile PRIME User manual

Stat Profile® PRIME™
CCS Analyzer
Instructions for
Use Manual
52920

Nova Prime Quick Start Guide
Confirm the analyzer is
Ready for analysis.
Displays Ready, desired
test menu shows no Orange
Icons.
Login if necessary. Press the Login icon then enter or
scan your User ID and Password.
Select the Sample Container and the Panel.
Prepare the sample for analysis then press to
extend the sample probe.
Position the sample over the
sample probe then press
Aspirate to aspirate the
sample.
Enter any additional patient or sample information needed
while the analysis is completed.
Review results.
2
1
3
4
6
7
5

Nova Biomedical SymBol directory
In vitro diagnostic medical device
Product fulfills the requirements of Directive
98/79 EC (IVDD)
Caution, consult accompanying documents
Consult instructions for use
Biological risk
Catalog number
Manufactured by
Control
Level
Batch code
Serial Number
Temperature limitation
Upper Limit of Temperature
Use by (last day of the month)
Electronic Waste
Authorized Representative
in the European Community
Laser Radiation - Do Not
Stare Into Beam
Class II/IEC 825 Laser
Product
Wavelength: 655 nm
LEVEL
REP
EC Nova Biomedical UK
LASER RADIATION
DO NOT STARE INTO BEAM
CLASS 2 LASER PRODUCT
WAVELENGTH: 650 nm
MAX. OUTPUT: 1.2 mW
EN 60825-1: 2002
SN
YYYY - MM
1

Preface
i
Stat Profile® PRIME™ CCS Instructions for Use Manual
Ordering Information
The Stat Prole® PRIME™ CCS Instructions for Use Manual
can be ordered from Nova Biomedical Order Services.
Write or call:
Nova Biomedical Corporation Telephone:[phone]
200 Prospect Street FAX: [phone]
Waltham, MA 02454-9141 (in the U.S.A.)
U.S.A. [phone]
(outside the U.S.A.)
Web: www.novabiomedical.com
REP
EC
Authorized Representative
Nova Biomedical UK Telephone:+ 44 1928 704040
Innovation House Fax:+ 44 1928 796792
Aston Lane South, Runcorn
Cheshire, WA7 3FY, UK
Trademark and Patents
Stat Prole is a registered Trademark of Nova Biomedical
Corporation.
Stat Prole Prime is a Trademark of Nova Biomedical
Corporation.
Copyright
Printed in the U.S.A. Copyright 2013, Nova Biomedical
Corporation, Waltham, MA 02454-9141

Prime CCS Instructions for Use Manual
Preface
ii
Technical Assistance
For technical assistance inside the United States, call Nova
Biomedical Technical Services at:
U.S.A.: 1-800-545-NOVA 1-781-894-0800 or
FAX: [phone]
For technical assistance outside the United States, call your
local Nova subsidiary or authorized distributor.
Nova Biomedical Canada Ltd.
17 - 2900 Argentia Road
Mississauga, Ontario L5N 7X9
Canada
Tel: [phone]
1 905 567 7700
Nova Biomedical France
Parc Technopolis - Bât. Sigma
3 avenue du Canada 1er étage
Les Ulis courtaboeuf
91940
France
Tel: + 33 1 64 86 11 74
Nova Biomedical UK
Innovation House
Aston Lane South, Runcorn
Cheshire, WA7 3FY
UK
Tel: + 44 1928 704040
Nova Biomedical GmbH
Messenhauser Str. 42
Roedermark
Urberach 63322
Germany
Tel: + 49 6074 8448 0
Nova Biomedical KK
B-3F Omori Bellport
26 Minami Oi 6-chome
Shinagawa-ku
Tokyo 140-0013
Japan
Tel: + (813) 5471-5461

Table of Contents
toc-1
52920A1 2013-09
1 Introduction 1-1
1.1 About This Manual...................................................1-1
1.2 Safety.......................................................................1-1
1.3 Installation and Use .................................................1-4
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................................. 1-8
1.6.2 Acceptable Anticoagulants ............................ 1-9
2 Getting Started 2-1
2.1 Power Up Procedure ...............................................2-3
2.2 The Home Screen: Ready ......................................2-4
2.2.1 Header Bar.................................................... 2-4
2.2.2 Selection Area ............................................... 2-5
2.2.3 Menu Bar....................................................... 2-6
2.3 Automatic Calibrations.............................................2-7
2.3.1 Manual Calibrations ...................................... 2-8
3 Sample Analysis 3-1
3.1 Analyzing Patient Samples ......................................3-1
3.1.1 Analyzing Syringe Samples .......................... 3-1
3.1.2 Utilizing the Luer Station .............................. 3-3
3.1.3 Analyzing Sample: Blood Collection Tube .... 3-6
3.1.4 Analyzing Sample: Capillary Tube ................ 3-8
3.2 The Sample Results Display..................................3-10
3.3 Analyzing QC and Prociency Samples ...............3-12
3.2.1 Analyzing Internal QC Samples .................. 3-12
3.2.2 Analyzing External QC Samples ................. 3-14
3.2.3 Analyzing Prociency Samples................... 3-15
4 Consumable Replacements 4-1
4.1 Scheduled Replacements........................................4-1
4.2 Calibrator Cartridge & Control Cartridge Changing .4-2
4.2.1 Change Calibrator Cartridge ......................... 4-3
4.2.2 Change Control Cartridge ............................. 4-4
4.3 Change Sensor Card ...............................................4-4

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Prime CCS Instructions for Use Manual
toc-2
5 Periodic Replacements 5-1
5.1 Pump Tubing Replacement .....................................5-1
5.2 Probe Replacement .................................................5-3
5.2 Reference Sensor Replacement..............................5-5
5.3 Printer Paper Replacement .....................................5-7
5.4 Safety Sample Port Replacement............................5-8
6 Troubleshooting 6-1
6.1 Troubleshooting Procedures....................................6-1
6.2 Error Log..................................................................6-2
6.3 Operator Flow Test ..................................................6-2
6.3.1 Flushing the Reference Sensor..................... 6-2
6.3.1 Flushing the Sensor Cartridge ...................... 6-3
6.3.1 Flushing the Sample Probe........................... 6-4
A Appendix A-1
A.1 Specications.......................................................... A-1
A.1.1 Analytical Specicity......................................A-3
A.2 Analytical Performance Studies.............................. A-5
A.3 Calibrator Cartridge .............................................. A-22
A.3.1 Traceability Calibrators, Controls, Standards. A-22
A.4 Reference Values ................................................. A-23
A.5 Ordering Information............................................. A-25
A.6 Warranty ............................................................... A-26
B Principles of Measurement B-1
B.1 Measured Values .................................................... B-1
B.1.1 Na+, K+, Cl-, and iCa.....................................B-1
B.1.3 Partial Pressure of PCO2..............................B-3
B.1.4 Partial Pressure of PO2.................................B-4
B.1.5 Hematocrit.....................................................B-4
B.1.6 Glucose.........................................................B-5
B.1.7 Lactate ..........................................................B-5
B.2 Calculated Values ................................................... B-6
B.2.1 Temperature Correction for Measured Values .B-6
B.2.2 Calculated Parameters..................................B-7

1-1
1. Intro.
1 Introduction
1 Introduction
This manual provides all necessary instructions for the routine
operation and upkeep of all Stat Prole Prime CCS Analyzer.
Please read this manual carefully. It has been prepared to
help you attain optimum performance from your Analyzer.
WARNING: Blood samples and blood products are
potential sources of infectious agents. Handle
all blood products and ow path components
(waste-line, capillary adapter, probe, sensor
card, etc.) with care. Gloves and protective
clothing are recommended. When performing
maintenance and troubleshooting procedures,
also use protective eyewear.
This section introduces the Prime CCSAnalyzer and covers
requirements, tests performed, procedural limitations, clinical
utility, and sample handling.
1.1 About This Manual
This manual is for the Stat Prole Prime CCS 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
Personnel operating this analyzer must be procient in the
operating and replacement procedures of the analyzer. The
following safety procedures must be followed.

1-2
Prime CCS Instructions for Use Manual
General Safety
1. Read the safety and operating instructions before
operating the analyzer.
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. Use only with a cart or stand that is recommended
by the manufacturer.
The analyzer and cart combination should be
used with care. Quick stops, excessive force, and
uneven surfaces may cause the analyzer and cart
combination to overturn.
7. Place the analyzer so that its location or position
does not interfere with its proper ventilation.
8. Place the analyzer away from heat sources.
9. Connect the analyzer to a power supply only of
the type described in the operating instructions or
marked on the analyzer.
10. Do not defeat the safety purpose of the polarized
or grounding type plug.
11. 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.
12. The analyzer should be cleaned only as
recommended by the manufacturer.
13. Take care not to let objects or liquids fall into the
analyzer.
14. The analyzer should be serviced by qualied service
personnel.
15. Do not attempt to service the analyzer beyond that
described in the operating instructions. All other
servicing should be referred to qualied service
personnel.

1-3
1. Intro.
1 Introduction
Electrical Safety
1. To reduce the risk of electric shock, do not remove
the cover.
2. There are no user serviceable parts inside the
analyzer.
3. Servicing must be done by qualified service
personnel.
4. Toreducetheriskofreorelectricshock,donot
expose the analyzer to water.
5. Use Nova Part Number 52413 external power supply
to power up the analyzer.
6. Ensure that the wall outlet receptacle is properly
wired and earth grounded.
7. DO NOT use a 3-to-2 wire plug adapter.
8. DO NOT use a 2-wire extension cord or a 2-wire
multiple-outlet power strip.
Federal Communications Commission (FCC) Notice
This device complies with Part 15 of the FCC Rules:
Operation is subject to the following conditions:
1. This device many not cause harmful interference, and
2. This device must accept any interference received,
Including interference that may cause undesired
operation
Changes and Modications not expressly approved by
Nova Biomedical Corporation can void your authority to
operate this equipment under Federal Communications
Commissions rules.
Radio Standards Specications (RSS) Notice
This device complies with Industry Canada licence-exempt
RSS standard(s).
Operation is subject to the following 2 conditions:
1. This device may not cause interference, and
2. This device must accept any interference, including
interference that may cause undesired operation
of the device.
Le présent appareil est conforme aux CNR d'Industrie
Canada applicables aux appareils radio exempts de licence.
L'exploitation est autorisée aux deux conditions suivantes :
1. l'appareil ne doit pas produire de brouillage, et
2. l'utilisateur de l'appareil doit accepter tout brouillage
radioélectrique subi, même si le brouillage est
susceptible d'en compromettre le fonctionnement.

1-4
Prime CCS Instructions for Use Manual
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. Wear appropriate laboratory attire, e.g., safety
glasses, gloves, lab coat, and breathing apparatus,
when working with hazardous materials.
5. Dispose of all waste solutions according to standard
hospital procedures.
1.3 Installation and Use
This section covers the installation requirements and
assembly procedures for the Stat Prole Prime CCS Analyzer.
Prior to use of the analyzer, operators should be familiar with
Chapter 2 Operation and Chapter 3 Operating Procedures.
NOTE: Under the Warranty, a Nova service representative
will install this equipment for you.
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 - 270 VAC
• Operating Frequency: 47 - 63 Hz
• Power Consumption: Less than 100 Watts
Ambient Operating Temperature:
• 15°C to 30°C (59°F to 86°F)
Operate at Humidity:
• 20 to 85% without condensation

1-5
1. Intro.
1 Introduction
Operate at Altitude:
• up to 12,000 feet/3650 meters
Dimensions:
Height: 15.4 in (39.1 cm)
Width: 12.0 in (30.5 cm)
Depth: 14.4 in (36.2 cm)
Weight:
17.5 lb (8.164 kg) without reagent pack
23 lb (10.45 kg) with full reagent pack
Lifting the Analyzer:
1. One person is needed to lift the analyzer.
CAUTION: Never use the door (open or closed) to assist
you in lifting the analyzer. The door cannot
support the weight of 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 at surface.
1.5 Intended Use, Tests Performed, and Clinical Utility
Intended Use
The Stat Prole Prime CCS Analyzer System is intended
for in vitro diagnostic use by health care professionals in
clinical laboratory settings for the quantitative determination
of pH, PCO2, PO2, Hct, Na+, K+, Cl-, iCa, Glu (Glucose), and
Lac (Lactate) in heparinized whole blood. It is not intended
for Point of Care use.
Measured Parameters
Stat Prole Prime CCS Analyzer: pH, PCO2, PO2, Hct,
Na+, K+, Cl-, iCa, Glu (Glucose), and Lac (Lactate)
Glucose and Lactate are optional.

1-6
Prime CCS Instructions for Use Manual
Calculated Parameters
From the directly measured results, the calculated results
are shown in Table 1-1 for each analyzer in the Stat Prole
Prime CCS.
Table 1-1. Calculated Parameters
Calculated Parameters
pH, PCO2, PO2(corrected to patient temperature)
Bicarbonate level (HCO3-)
Total Carbon Dioxide (TCO2)
Base Excess of the blood (BE-b)
Base Excess of extracellular uid (BE-ecf)
Standard Bicarbonate Concentration (SBC)
Total Carbon Dioxide (TCO2)
Oxygen Content (O2Ct)
Oxygen Capacity (O2Cap)
Alveolar Oxygen (A)
Arterial Alveolar Oxygen Tension Gradient (AaDO2)
Arterial Alveolar Oxygen Tension Ratio (a/A)
Respiratory Index (RI)
P50
PO2/FIO2ratio
Oxygen Saturation (SO2%)
Hemoglobin (Hbc)
Anion Gap
Normalized Calcium, nCa

1-7
1. Intro.
1 Introduction
Clinical Utility1The following list includes the clinical utility
information for each of the analytes measured on the Stat
Prole Prime CCS Analyzer.
PCO2,Whole blood measurement of blood gases is used
in the diagnosis and treatment of life-threatening
acid-base disturbances in critically ill patients with
numerous metabolic and pulmonary diseases.
Na+Sodium measurement is used in the diagnosis and
treatment of aldosteronism, diabetes insipidus,
adrenal hypertension, Addison’s disease,
dehydration, or diseases involving electrolyte
imbalance.
K+Potassium Measurement is used to monitor
electrolyte balance in the diagnosis and treatment
of disease conditions characterized by low or high
potassium levels.
Cl-Chloride measurement is used in the diagnosis and
treatment of electrolyte and metabolic disorders
such as cystic brosis and diabetic acidosis.
iCa Ionized Calcium measurement is used in the
diagnosis and treatment of hypertension, renal
disease, and vitamin D related disorders. Also
useful in the diagnosis and treatment of patients
with increased total protein and/or albumin levels,
as in dehydration.
Glu Glucose measurement is used in the diagnosis and
treatment of carbohydrate metabolism disturbances
including diabetes mellitus, neonatal hypoglycemia,
and idiopathic hypoglycemia, and of pancreatic islet
cell carcinoma.
Lac Lactate (lactic acid) measurement is used to evaluate
the acid-base status of patients suspected of having
lactic acidosis.
Ref. 1. Burtis, Carl A. Ashwood, Edward R., Burns, David R., 2011.
Tietz Textbook of Clinical Chemistry and Molecular Diagnostics.
5th ed, Philadelphia, PA: W. B. Saunders Co.
PO2,
pH

1-8
Prime CCS Instructions for Use Manual
1.6 The Sample
Sodium or lithium heparin whole blood samples from
syringes, open tubes, small cups, and capillary tubes can be
used on the Stat Prole Prime CCS Analyzer. The minimum
sample size for analysis is 100 µL.
1.6.1 Handling Requirements
Correct sample handling is critical to ensure that the blood gas
values obtained accurately reect the in vivo state. Ensure
that all samples have been obtained and stored following
consistent, clinically accepted protocols. It is particularly
important to ensure that samples are well mixed before
introduction into the analyzer. Nova Biomedical recommends
that you analyze the sample within 15 minutes for blood
gases. Storing samples on ice is not recommended. Using
iced samples may elevate the PO2result.1
1. Clinical and Laboratory Standards Institute (CLSI),
(March 4) 2009, Blood Gas and pH Analysis and
Related Measurements; Approved Guideline—
Second Edition (C46-A2).

1-9
1. Intro.
1 Introduction
1.6.2 Acceptable Anticoagulants
• Sodium and lithium heparins are the acceptable
anticoagulants for use with the analyzer.
• EDTA, citrate, oxalate, and sodium uoride ARE
NOT acceptable for use.
• Depending on the amount of heparin used in the
collection syringe and whether it is lled to capacity
with blood, heparin concentrations of 20 I.U. per mL
to over 100 I.U. per mL may result.
• Excess sodium heparin may elevate sodium results.
• Liquid or dry heparin when present in excess may
cause errors. Ensure blood collection devices are
lled per manufacturer instructions.
• Our experience suggests that lyophilized lithium
heparin giving a nal concentration in blood of not
more than 20 I.U. per mL is acceptable.
CAUTION: Stat Prole Prime CCS Analyzer users
should take careful note of these considerations
when establishing reference intervals and
interpreting results.

1-10
Prime CCS Instructions for Use Manual