ITC AVOXimeter 4000 User manual

AVOXimeter®4000
Whole Blood Oximeter
Operator’s Manual

Manufacturing Company Location
International Technidyne Corp
8 Olsen Avenue, Edison, New Jersey USA
Phone: [phone]
Fax: [phone]
web site: www.itcmed.com
Copyright and Trademarks
Copyright© 2007 International Technidyne Corporation (ITC). All rights reserved. This material
may not be reproduced or copied, in whole or in part, without the written permission of ITC.
ITC and AVOXimeter are registered trademarks of International Technidyne Corporation in the
United States and other jurisdictions.
U.S. Patents. 5,430,542 and 6,262,798. Euro/UK Patent 0663070. Other patents pending.
Technical Support
Contact ITC Technical Support at [phone] or [phone], or by e-mail at
[e-mail].
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Table of Contents
1INTRODUCTION .......................................................................................................1
Intended Use of the ITC AVOXimeter 4000............................................................... 1
Summary and Explanation of the Test....................................................................... 1
Glossary of Abbreviation Equivalents ……………………………………………………2
Operating Precautions and Warnings ........................................................................ 3
Limitations.................................................................................................................. 4
2DESCRIPTION ..........................................................................................................5
Front Panel ................................................................................................................ 5
Keypad....................................................................................................................... 6
Menus ....................................................................................................................... 7
Test Cuvettes............................................................................................................. 8
Connections ............................................................................................................... 9
Automatic Standby and Shutdown............................................................................. 9
Instrument Lockouts................................................................................................... 9
Instrument Specifications......................................................................................... 10
Reportable Range........................................................................................ 10
Accuracy ...................................................................................................... 10
Precision ...................................................................................................... 10
Interference.................................................................................................. 11
Calibration................................................................................................................ 11
3GETTING STARTED...............................................................................................13
Unpacking and Inspection........................................................................................ 13
Materials Provided ....................................................................................... 13
Materials Required But Not Provided .......................................................... 13
Optional Materials........................................................................................ 14
Charging the Batteries ............................................................................................. 14
Setting Up the Instrument ........................................................................................ 15
Setting Display Backlighting ........................................................................ 15
Specifying Units for Total Hemoglobin (THb) .............................................. 15
Enabling or Disabling Display of [sO2], [O2Ct], and [O2Cap]...................... 16
Enabling or Disabling Suppression of Negative Values............................... 16
Changing the Date and Time....................................................................... 17
Setting the Standby Delay ........................................................................... 18
Specifying Entry of User ID and/or Patient ID.......................................................... 19
Specifying Mandatory Entry of an Authorized User ID................................. 19
Specifying Optional Entry of a User ID Whenever a Test is Run................. 26
Specifying Optional Entry of a Patient ID Whenever a Test is Run ............. 27
Specifying a Different Value for Hüfner’s Number ................................................... 28
Calibration................................................................................................................ 29
Cuvette Calibration Code............................................................................. 29
Re-Calibration.............................................................................................. 29
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4OP .....................................................319
Startup ..................................................................................................................... 31
Sa
Ru ........................................ 33
Running a Test on a Patient Sample ........................................................... 33
Using the Printer
Prin ing th esults................................................................. 35
Specifying Automatic Printing of Results ..................................................... 35
Changing the Serial Port Baud Rate and Parity .......................................... 35
Data Managemen .................................................................. 36
Revie ing st Sample................................................. 36
Locating, R ....................................... 37
Printi g a .................................................. 37
Aborting Printing of Results ......................................................................... 37
Quality Con ......................................................................................................... 38
Performing Optical Quality Control .............................................................. 38
Run ng L ......... 40
Entering Liquid Control Lot Numbers........................................................... 42
Ente g C .............................................................. 43
Shutdown ................................................................................................................. 44
Troubleshoo ng ....................................................................................................... 45
5MAINTENANCE ......................................................................................................49
Verification 49
Cleaning the Opti
Replacing the B ................................................................................... 55
6QUALITY CONTR .................................59
7WARRANTY............................................................................................................63
Certification, arranty and Service Warranty, and Service ..................................... 63
8SAFETY ST NDARD 65
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions .................... 66
Guidance an Ma y ................. 67
INDEX ......
ERATION..................................................... 29
mple Collection and Preparation ......................................................................... 32
Sample Collection........................................................................................ 32
Sample Preparation ..................................................................................... 32
nning a Test.................................................................
...................................................................................................... 35
e Current Test Rt
t.................................
and/or Printing the Law
eviewing, and/or Printing any Sample
ll Stored Datan ..............................
trol
ni iquid Controls .....................................................................
rin uvette Lot Numbers ......
ti
of Instrument Temperature....................................................................
cal Detector .................................................................................. 50
tterya ............
OL LOGS ..................................................
W
A S ...........................................................................................
d nufacturer’s Declaration – Electromagnetic Immunit
......................................................................................................69
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Important Labels and Symbols
Before using the ITC AVOXimeter 4000, it is essential that the contents of this Operator’s
Manual, any labels on the instrument or its packaging, and instructions accompanying ITC
AVOXimeter 4000 cuvettes are read and understood by the operator. These materials make
reference to additional symbols that are explained below:
Product Conforms to Directive 98/79, 27 October 1998 on In-Vitro Diagnostic
Medical Devices
Serial Number of Instrument
Lot Number of Cuvettes
ITC Catalogue Number of Devices
Do Not Reuse– Single Use Only
Upper and Lower Temperature Limitations (For Storage or Use)
For in vitro Diagnostic Use
Attention - Read Accompanying Documentation or Instructions
Consult Instructions for Use
Input Port for DC Power Cord from AC/DC Power Module - Polarity, VDC
and A Input
Serial Output Port for Data Transfer – RS232C
Temperature Probe Input
Name and Address of Manufacturer
Warning - Biohazard
Medical Equipment per Annex 1A, Item 8 Directive 2002/96/EC For Electronic
Equipment Waste – Contact ITC Technical Support @ 1-800-631-5945
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ITC AVOXimeter 4000 Operator’s Manual
1 Introduction
Int imeter 4000
The ITC
individual poi
(%0
heparin ([02Ct]), percent
saturation (S
calc
No sample p
into a disp 00
then illuminat le
at each of the d computes the results. In less than 10 seconds, the total
hemogl
methemo
front panel.
Data man d with the instrument. These capabilities include
stora
tagging
ended Use of the ITC AVOX
AVOXimeter 4000 is a battery-operated desktop whole blood oximeter that performs
nt-of-care measurements of total hemoglobin (tHb), oxyhemoglobin saturation
2Hb), carboxyhemoglobin (%COHb), and methemoglobin (%MetHb) on freshly-drawn or
- or EDTA-anticoagulated whole blood samples. Oxygen content
O2) and oxygen carrying capacity (O2Cap) of the blood sample are automatically
ulated from the %Hb02and THb measurements.
reparation is required, and analysis is quickly accomplished by injecting the sample
osable cuvette and inserting the cuvette into the instrument. The ITC AVOXimeter 40
es the sample with multiple wavelengths, records the optical density of the samp
wavelengths, an
obin concentration and the percentages of oxyhemoglobin, carboxyhemoglobin, and
globin in the sample are shown in appropriate units on the liquid-crystal display on the
agement capabilities are include
ge of up to 100 patient or QC results, designation of quality control levels and lot numbers,
of test results with date, time, Patient ID and/or Operator ID, and printing of results.
Summary
The ITC
disposable a whole blood sample into a cuvette, the
cuvette is in
results will
pressed, cle
The result ca as run, the Patient
ID, Operator ID, and othe
which h th
Up to th e
in the ITC A
numbers ca
authorized o
run.
The ITC AVOXimeter 4000 measures oxygenated hemoglobin (O2Hb), reduced hemoglobin
(HHb), methemoglobin (MetHb), and carboxyhemoglobin (COHb) directly, using novel optics and
multiple wavelengths. This reduces interference from dyshemoglobins and other interfering
substances such as fetal hemoglobin and bilirubin and minimizes the effects of hemolysis.
and Explanation of the Test
AVOXimeter 4000 measures whole blood tHb, %02Hb, %COHb, and %MetHb using
single-use cuvettes. The operator inserts
serted into the test chamber on the instrument, and the results are displayed. The
remain on the display after the cuvette is removed from the instrument until any key is
aring the screen.
n be automatically printed along with the time and date the test w
r information entered. The result is also saved in an internal database,
e capability to store up to 100 results.
liquid control lot numbers for each level of Liquid Quality Control (LQC) can be stored
VOXimeter 4000 and must be tagged to the stored or printed records. Cuvette lot
n also be tagged to the LQC records. The instruments can be configured so that only
perators can operate the system and that patient IDs can be entered for each test
as
re
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ITC AVOXimeter 4000 Operator’s Manual
The measured values are used to calculate total hemoglobin (tHb) and percent oxyhemoglobin
ample, using the fractional method described below:
tHb) + (COHb)
saturation [%02Hb] of the s
(tHb) = (O2Hb) + (HHb) + (Me
(O2Hb) x 100
%O2Hb = (tHb)
Oxygen content [O2Ct] of the sample is then calculated:
1.39 x tHb x % O2Hb
O2Ct = 100
where 1.39 is the amount of oxygen assumed to be carried by one gram of oxygenated
hemoglobin (Hϋfner’s Number). Depending on your facility protocols, the Hϋfner’s Number stored
in the ITC AVOXimeter 4000 can be set at any value in the range of 1.30 to 1.39 (see page 28).
Glossary of Abbreviation Equivalents
In some cases, the display screen of the ITC AVOXimeter 4000 does not show the most
commonly used format for a specific constituent’s abbreviation. Below is a glossary of
abbreviation equivalents to ensure that users fully understand each reading on the ITC
AVOXimeter 4000 display.
Constituent AVOXimeter 4000
Display Conventional Equivalent
Total Hemoglobin tHb tHb
Fractional O2 Saturation sO2SO2
Oxygen Content O2Ct O2CT
Carboxyhemoglobin COHb COHb
Methemoglobin MetHb MetHb
Oxyhemoglobin Saturation %O2Hb %O2Hb
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