NOVA BIOMEDICAL Stat Profile PRIME Manuale utente
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 Prole® PRIME™ CCS Instructions for Use Manual
can be ordered from Nova Biomedical Order Services.
Write or call:
Nova Biomedical Corporation Telephone:1-800-458-5813
200 Prospect Street FAX: 1-781-893-6998
Waltham, MA 02454-9141 (in the U.S.A.)
U.S.A. +1-781-899-0417
(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 Prole is a registered Trademark of Nova Biomedical
Corporation.
Stat Prole 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: 1-781-894-0585
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: 1-800-263-5999
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 Prociency 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 Prociency 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
10
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 Specications.......................................................... A-1
A.1.1 Analytical Specicity......................................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
Indice
Altri manuali NOVA BIOMEDICAL Strumento di misura
NOVA BIOMEDICAL
NOVA BIOMEDICAL STATSTRIP Manuale utente
NOVA BIOMEDICAL
NOVA BIOMEDICAL Lactate Plus Manuale
NOVA BIOMEDICAL
NOVA BIOMEDICAL MAX PRO CREATININE eGFR Manuale
NOVA BIOMEDICAL
NOVA BIOMEDICAL Nova StatSensor Xpress-i Manuale
NOVA BIOMEDICAL
NOVA BIOMEDICAL Max Creat eGFR Manuale utente
NOVA BIOMEDICAL
NOVA BIOMEDICAL StatStrip Xpress Manuale
