Accriva Diagnostic AVOXimeter 4000 User manual

Operator’s Manual

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Manufacturing Company Location
Accriva Diagnostics, Inc.
6260 Sequence Drive, San Diego, CA USA
Phone: [phone]
Fax: [phone]
web site: www.accriva.com
Copyright and Trademarks
Copyright© 2015 Accriva Diagnostics, Inc. All rights reserved. This material may not be
reproduced or copied, in whole or in part, without the written permission of Accriva.
Accriva and AVOXimeter are registered trademarks of Accriva Diagnostics, Inc. 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 Technical Support at [phone] or [phone], or by e-mail at
[e-mail].

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Table of Contents
1INTRODUCTION......................................................................................................6
Intended Use of the AVOXimeter 4000.....................................................................6
Summary and Explanation of the Test......................................................................6
Glossary of Abbreviation Equivalents ……………………………………………………7
Operating Precautions and Warnings.......................................................................8
Limitations................................................................................................................9
2DESCRIPTION.......................................................................................................10
Front Panel.............................................................................................................10
Keypad...................................................................................................................11
Menus ...................................................................................................................12
Test Cuvettes.........................................................................................................13
Connections...........................................................................................................14
Automatic Standby and Shutdown..........................................................................14
Instrument Specifications .......................................................................................15
Reportable Range......................................................................................15
Accuracy....................................................................................................15
Precision ....................................................................................................15
Interference................................................................................................16
Calibration..............................................................................................................16
3GETTING STARTED .............................................................................................17
Unpacking and Inspection......................................................................................17
Materials Provided......................................................................................17
Materials Required But Not Provided..........................................................17
Optional Materials ......................................................................................18
Charging the Batteries............................................................................................18
Setting Up the Instrument.......................................................................................19
Setting Display Backlighting .......................................................................19
Specifying Units for Total Hemoglobin (THb)..............................................19
Enabling or Disabling Display of [sO2], [O2Ct], and [O2Cap]........................20
Enabling or Disabling Suppression of Negative Values ..............................20
Changing the Date and Time......................................................................21
Setting the Standby Delay..........................................................................22
Specifying Entry of User ID and/or Patient ID.........................................................23
Specifying Mandatory Entry of an Authorized User ID................................23
Specifying Optional Entry of a User ID Whenever a Test is Run.................28
Specifying Optional Entry of a Patient ID Whenever a Test is Run.............29
Specifying a Different Value for Hüfner’s Number...................................................30
Calibration..............................................................................................................31
Cuvette Calibration Code ...........................................................................31
Re-Calibration............................................................................................31

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4OPERATION.......................................................................................................329
Startup ...................................................................................................................32
Sample Collection and Preparation.........................................................................33
Sample Collection.......................................................................................33
Sample Preparation....................................................................................33
Running a Test.......................................................................................................34
Running a Test on a Patient Sample ..........................................................34
Using the Printer.....................................................................................................36
Printing the Current Test Results................................................................36
Specifying Automatic Printing of Results.....................................................36
Changing the Serial Port Baud Rate and Parity..........................................36
Data Management..................................................................................................37
Reviewing and/or Printing the Last Sample ................................................37
Locating, Reviewing, and/or Printing any Sample.......................................38
Printing all Stored Data...............................................................................38
Aborting Printing of Results ........................................................................38
Quality Control........................................................................................................39
Performing Optical Quality Control..............................................................39
Running Liquid Controls..............................................................................41
Entering Liquid Control Lot Numbers..........................................................43
Entering Cuvette Lot Numbers....................................................................44
Shutdown ...............................................................................................................45
Troubleshooting......................................................................................................46
5MAINTENANCE....................................................................................................49
Verification of Instrument Temperature...................................................................49
Cleaning the Optical Detector.................................................................................50
Replacing the Battery .............................................................................................54
6QUALITY CONTROL LOGS................................................................................. 57
7WARRANTY .........................................................................................................60
Certification, Warranty and Service Warranty, and Service.....................................60
8SAFETY STANDARDS ......................................................................................... 62
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions....................63
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity..................64
INDEX .........................................................................................................65
32

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Important Labels and Symbols
Before using the AVOXimeter 4000, it is essential that the contents of this Operator’s Manual,
any labels on the instrument or its packaging, and instructions accompanying 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/EC, 27 October 1998 on In-Vitro Diagnostic
Medical Devices
Serial Number of Instrument
Lot Number of Cuvettes
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 Technical Support @ 1-800-579-2255

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1 Introduction
Intended Use of the AVOXimeter 4000
The AVOXimeter 4000 is a battery-operated desktop whole blood oximeter that performs
individual point-of-care measurements of total hemoglobin (tHb), oxyhemoglobin saturation
(%02Hb), carboxyhemoglobin (%COHb), and methemoglobin (%MetHb) on freshly-drawn or
heparin- or EDTA-anticoagulated whole blood samples. Oxygen content ([02Ct]), percent
saturation (SO2) and oxygen carrying capacity (O2Cap) of the blood sample are automatically
calculated from the %Hb02and tHb measurements.
No sample preparation is required, and analysis is quickly accomplished by injecting the sample
into a disposable cuvette and inserting the cuvette into the instrument. The AVOXimeter 4000
then illuminates the sample with multiple wavelengths, records the optical density of the sample
at each of the wavelengths, and computes the results. In less than 10 seconds, the total
hemoglobin concentration and the percentages of oxyhemoglobin, carboxyhemoglobin, and
methemoglobin in the sample are shown in appropriate units on the liquid-crystal display on the
front panel.
Data management capabilities are included with the instrument. These capabilities include
storage of up to 100 patient or QC results, designation of quality control levels and lot numbers,
tagging of test results with date, time, Patient ID and/or Operator ID, and printing of results.
In vitro diagnostic use, For Professional Use, Rx Only
Summary and Explanation of the Test
The AVOXimeter 4000 measures whole blood tHb, %02Hb, %COHb, and %MetHb using
disposable single-use cuvettes. The operator inserts a whole blood sample into a cuvette, the
cuvette is inserted into the test chamber on the instrument, and the results are displayed. The
results will remain on the display after the cuvette is removed from the instrument until any key is
pressed, clearing the screen.
The result can be automatically printed along with the time and date the test was run, the Patient
ID, Operator ID, and other information entered. The result is also saved in an internal database,
which has the capability to store up to 100 results.
Up to three liquid control lot numbers for each level of Liquid Quality Control (LQC) can be stored
in the AVOXimeter 4000 and must be tagged to the stored or printed records. Cuvette lot
numbers can also be tagged to the LQC records. The instruments can be configured so that only
authorized operators can operate the system and that patient IDs can be entered for each test
run.
The 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.

AVOXimeter 4000 Operator’s Manual
7
The measured values are used to calculate total hemoglobin (tHb) and percent oxyhemoglobin
saturation [%02Hb] of the sample, using the fractional method described below:
(tHb) = (O2Hb) + (HHb) + (MetHb) + (COHb)
%O2Hb =
(O2Hb) x 100
(tHb)
Oxygen content [O2Ct] of the sample is then calculated:
O2Ct =
1.39 x tHb x % O
2
Hb
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 AVOXimeter 4000 can be set at any value in the range of 1.30 to 1.39 (see page 30).
Glossary of Abbreviation Equivalents
In some cases, the display screen of the 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 AVOXimeter 4000 display.
Constituent
AVOXimeter 4000
Display
Conventional
Equivalent
Total Hemoglobin
tHb
tHb
Fractional O2 Saturation
sO2
SO2
Oxygen Content
O2Ct
O2Ct
Carboxyhemoglobin
COHb
COHb
Methemoglobin
MetHb
MetHb
Oxyhemoglobin Saturation
%O2Hb
%O2Hb

AVOXimeter 4000 Operator’s Manual
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Operating Precautions and Warnings
●For in vitro Diagnostic use.
●Do not allow blood, water, or other liquids to enter the instrument.
●The AVOXimeter 4000 instrument is designed for use only with AVOXimeter 4000
cuvettes.
●Do not re-use test cuvettes.
●Always keep cuvettes in sealed bag with desiccant, and replace desiccant if the
indicator dot on the desiccant pack indicates the presence of mositure.
●When filling cuvette, do not use excessive pressure on the syringe or cause the
vent patch to bulge outward by overfilling the cuvette.
●For proper calibration and calibration verification, use only the controls recommended
in this manual. Controls from other sources may yield erroneous results.
●The AVOXimeter 4000 instrument is designed to be used for testing in a stationary
position. DO NOT perform testing while carrying or holding the instrument.
●In order to charge the AVOXimeter 4000 instrument, the AC power cord should be
plugged into an electrical service outlet and the AC/DC power module while the DC
power cord from the AC/DC power module is plugged into the DC port in the back
of the instrument.
●DO NOT expose the AVOXimeter 4000 instrument to extreme temperature (above
35°C, 95°F). Such exposure could affect the performance of any type of electronic
instrumentation.
●DO NOT drop the AVOXimeter 4000 instrument, and do not use the results if the
instrument is dropped during a test.
●Only properly qualified personnel should attempt to open and perform work on the
AVOXimeter 4000 instrument as identified in this manual.
●DO NOT remove the AC/DC power module from the AVOXimeter 4000 instrument
by pulling on the cord.
The use of accessory equipment (e.g., printers, etc.) not identified in this manual either
in the patient vicinity, or that does not comply with either the equivalent safety
requirements of this equipment or IEC/EN 61010-1:2010 or IEC/EN 61010-2-101:2002,
may lead to a reduced level of safety with the resulting system.
Any items exposed to human blood, plasma or serum must be handled cautiously as a
biohazardous material in accordance with laboratory safety practices and federal and
local regulations. Federal, state and local laws and regulations require that hazardous
waste be disposed of in a specific manner. Waste material from the AVOXimeter 4000
which may be classified as biohazardous include used cuvettes. It is important that
steps be taken to dispose of these materials in accordance with the prevailing
regulations in your location.

AVOXimeter 4000 Operator’s Manual
9
Limitations
Do not disturb the instrument while a test is in progress.
As with all diagnostic tests, AVOXimeter 4000 test results should be scrutinized in light of a
specific patient’s condition and therapy. Any results exhibiting inconsistency with the patient’s
clinical status should be repeated or supplemented with additional test data.

AVOXimeter 4000 Operator’s Manual
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2 Description
The AVOXimeter 4000 (Figure 1) is a tabletop device for use at the bedside. It contains a test
chamber which performs all operations to measure the concentrations of reduced oxyhemoglobin
(HHb), oxyhemoglobin saturation (%02Hb), carboxyhemoglobin (COHb), and methemoglobin
(MetHb) of a whole blood sample after the operator inserts a test cuvette containing the sample
into the test chamber.
The concentration of total hemoglobin (tHb), the relative fractions of carboxyhemoglobin
(%COHb) and methemoglobin (%MetHb), and the oxygen content (02) of the blood sample are
then automatically calculated and reported.
Each AVOXimeter 4000 is calibrated at the factory. The AVOXimeter 4000 can be operated either
from its internal batteries or from the AC adapter. The batteries are charged whenever the AC
Adapter is connected.
Figure 1. AVOXimeter 4000 Oximeter
Front Panel
The front panel (Figure 2) contains the test chamber, a keypad with the key, action and
menu keys, number keys, and a display panel. Operator instructions are shown on the display
panel, and the operator enters commands and information using the keypad.
When the test is completed, the results are shown on the display panel and stored in system
memory for current or future printing.
The display panel is illuminated to enhance visibility in low light conditions. The illumination can
be adjusted (or turned off) to conserve power during battery operation.
Test Cuvette
Finger Grip
Display
Panel
Keypad
Test Cuvettes
Optical QC
Filters
Printer (Optional)
Test Chamber
Temperature
Probe