AVOXimeter 4000 Operators Manual May 2015

Manufacturing Company Location Accriva Diagnostics, Inc. 6260 Sequence Drive, San Diego, CA USA Phone: 1-858-263-2300 Fax: 1-858-314-6700 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 (800) 579-2255 or (858) 263-2502, or by e-mail at [email protected].

ii

Table of Contents 1

INTRODUCTION ...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

2

DESCRIPTION...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

3

GETTING 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

iii

4

OPERATION ... 329 32 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

5

MAINTENANCE ... 49 Verification of Instrument Temperature ...49 Cleaning the Optical Detector ...50 Replacing the Battery ...54

6

QUALITY CONTROL LOGS ... 57

7

WARRANTY ... 60 Certification, Warranty and Service Warranty, and Service ...60

8

SAFETY STANDARDS ... 62 Guidance and Manufacturer’s Declaration – Electromagnetic Emissions ...63 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity...64

INDEX

iv

... 65

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

v

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 %Hb02 and 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.

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AVOXimeter 4000 Operator’s Manual

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

=

(O2Hb) + (HHb) + (MetHb) + (COHb) (O2Hb) x 100 (tHb)

Oxygen content [O2Ct] of the sample is then calculated: O2Ct

=

1.39 x tHb x % O2Hb 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 Total Hemoglobin Fractional O2 Saturation Oxygen Content Carboxyhemoglobin Methemoglobin Oxyhemoglobin Saturation

AVOXimeter 4000 Display tHb sO2 O2Ct COHb MetHb %O2Hb

Conventional Equivalent tHb SO2 O2Ct COHb MetHb %O2Hb

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AVOXimeter 4000 Operator’s Manual

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.

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AVOXimeter 4000 Operator’s Manual

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.

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AVOXimeter 4000 Operator’s Manual

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. Test Chamber Printer (Optional) Display Panel

Temperature Probe

Keypad

Finger Grip

Optical QC Filters

Test Cuvette Test Cuvettes

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.

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AVOXimeter 4000 Operator’s Manual

Test Chamber

Number Keys (White)

Action Keys (Grey)

Enter/On Key (Red)

Display Panel

Menu Keys (Grey)

Figure 2. Front Panel

Keypad The routine analysis of blood samples does not require the use of menus or the numeric keypad. However, these enable the user to take advantage of many useful features. The purpose of each key is summarized below: Key

Purpose Switch the instrument on. Select a command. Display a menu of commands for calibration, printing, stored data, and shutdown. Display a menu of commands for entering hemodynamic variables, entering device settings, entering the time and date, viewing battery status and temperature, and managing data. Print the results that are displayed. and

Respond to questions that are displayed. Backspace over a numerical entry (such as a QC lot number) so that it can be corrected. Return to the previous menu.

to

Enter characters for Operator IDs or Patient IDs. Enter a character for selection of a command.

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AVOXimeter 4000 Operator’s Manual

Menus The principal menus, their commands, and the procedure to access each menu are summarized below: Note:

Press the

Menu

Main Menu

Commands

Access Press the key when a test is not running or another menu is not active.

Calibration Submenu

Press followed by main menu is displayed.

while the

Printer Mode Submenu

Press followed by main menu is displayed.

while the

Stored Data Submenu

Press followed by main menu is displayed.

while the

Data Menu

12

button at any time to return to the previous menu.

Press the key when a test is not running or another menu is not active.

Data Management Submenu

Press followed by data menu is displayed.

while the

Device Settings Submenu (Page 1)

Press followed by data menu is displayed.

while the

Device Settings Submenu (Page 2)

Press followed by while Page 1 of the device settings menu is displayed.

Time, Date, and Temperature Submenu

Press followed by data menu is displayed.

while the

AVOXimeter 4000 Operator’s Manual

Test Cuvettes Tests are performed with single-use disposable test cuvettes (Figure 3). Each test cuvette contains a finger grip, filling port, optical window, and a vent patch.

Filling Port Finger Grip Optical Window

Light Path Vent Patch

Figure 3. Test Cuvette A whole blood sample is inserted into a test cuvette by connecting a small syringe containing the whole blood sample to the filling port and then gently pressing the syringe plunger to dispense approximately 50 µL of whole blood into the test cuvette. Air escapes from the vent patch at the end of the test cuvette while the whole blood sample is being inserted. The test cuvette (with the syringe still attached) is then inserted into the test chamber of the instrument (see page 33 for details). Note:

Be sure to handle the cuvette either by the edges or by the finger grip. Refer to the package insert accompanying the test cuvettes for storage and handling instructions.

●

Remove any blood or debris from the exterior of the test cuvette before inserting it into the test chamber.

●

After filling the cuvette with blood, inspect the vent patches to ensure they are not bulging out. If a vent patch protrudes, discard the cuvette. Do not insert a cuvette with a protruding vent patch into the test chamber.

BIOHAZARD WARNING: 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.

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AVOXimeter 4000 Operator’s Manual

BIOHAZARD WARNING: 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.

Connections Connections to the power supply and an optional printer (or a computer) are made at the rear of the instrument (Figure 4). Use only the power supply provided with the instrument. Serial Number Label

Carrying Handle

AC Adapter Connector Printer or Computer Connector

Temperature Sensor Connector

Figure 4. Rear Panel Components

Automatic Standby and Shutdown The AVOXimeter 4000 enters a low-power standby mode after the instrument has been idle for a specified period of time (the standby delay). The instrument is factory preset for a standby delay time of 60 minutes, but a time of 10 to 180 minutes can be specified (see page 22). To resume normal operation when the instrument is in standby, press and hold down any key for one second. Note:

The AVOXimeter 4000 also enters standby if the battery charge becomes critically low.

The AVOXimeter 4000 shuts down after it has been in standby for 4 hours.

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AVOXimeter 4000 Operator’s Manual

Instrument Specifications Size Weight Operating Temperature Battery Type Operating Time On Battery

20.3 cm (8.0 in) x 25.4 cm (10.0 in) x 9.5 cm (3.8 in) 1.8 kg (4 lbs) Room temperature (15°C to 30°C, 59°F to 86°F) Nickel Cadmium (NiCad) Approximately 8 hours (constant run) or 10 complete test cycles per charge. Tests may also be run while the AVOXimeter 4000 is plugged into the AC/DC power module.

Anticipated Battery Life

Approximately 500 charge / discharge cycles

Power Supply/Chargers

Input: 100 / 240 VAC, 50 / 60 Hz Output: 12 VDC, 800 mA

Serial Data Port Sample Type Sample Volume Analysis Time Analysis Wavelengths

RS232C Whole blood 50 µL 7 to 10 seconds per sample 5

Reportable Range tHb

4 to 25 g/dL

%O2Hb

0 to 100%

%COHb

0 to 75%

%MetHb

0 to 85%

[O2]

0 to 35 mL O2/dL

Accuracy tHb (>10 g/dL)

±0.45 g/dL

tHb (<10 g/dL)

±0.35 g/dL

%O2Hb

±1.6%

%COHb

±2%

%MetHb

±1.5%

Precision tHb

0.3 g/dL

%O2Hb

0.8 % O2Hb

%COHb

1 % COHb

%MetHb

0.7 % MetHb

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AVOXimeter 4000 Operator’s Manual

Interferences tHb

%O2Hb

%COHb

%MetHb

Bilirubin (11 mg/dL)

None

None

< 1%

< 1%

Hemolysis

None

None

< 1%

< 1%

Fetal Hemoglobin (tHb = 13.5 g/dL, HbF = 100%

< 0.45 g/dL

< 1%

< 0.6% per %HbF

< 1%

Indocyanine Green Dye (<10 mg/L)

< 0.45 g/dL

< 1%

< 1%

< 1%

Methemoglobin (tHb = 16 g/dL, MetHb <10%, 7.1 < pH < 7.8)

< 0.2 g/dL

< 1%

Calibration The AVOXimeter 4000 is factory-calibrated and employs highly stable state-of-the-art light sources. Should recalibration be required please contact a Technical Support representative. Proper calibration also requires entry of the correct cuvette pathlength by the user (see page 30) and use of a customary value for Hüfner’s number (see page 30). CAUTION: If quality control results are not acceptable, erroneous results are encountered, or error messages are displayed, the most likely cause may be contamination of the optical detector by blood or debris, which cannot be resolved by re-calibration. Consult the Troubleshooting section for additional information.

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AVOXimeter 4000 Operator’s Manual

3 Getting Started Unpacking and Inspection Note:

Inspect each component for damage when unpacking. If damage is observed, contact your shipping representative immediately. 1.

Remove any protective packaging that may be present around the instrument.

2.

Examine the packaging material to be sure that the AC Adapter, temperature probe, connecting cables, or other components have been removed. The materials that are provided are listed below. Note:

Do not discard the packaging material. It should be preserved for future use, in the event that it is necessary to re-pack the instrument for shipping or transport.

Materials Provided

Note:

Item

Quantity

AVOXimeter 4000 Instrument

1

Power Supply

1

Temperature Probe

1

Operator’s Manual

1

Quality Control Filters

2

An AC power cord is supplied only for the 110VAC version of the US/Canada/Japan instrument. For all others, the customer must obtain a 3 conductor AC power cord that is compatible with an IEC 320 connection at the power supply AC inlet and any other local requirements.

Materials Required But Not Provided Item

Quantity

AVOXimeter 4000 Cuvettes

As Needed

Liquid Controls (Manufactured by RNA) See page 41 for additional information

As Needed

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AVOXimeter 4000 Operator’s Manual

Optional Materials Item

Quantity

Dymo Printer • 110 V • 220 V

1

Printer Paper

As Needed

Charging the Batteries Charge the batteries before the system is used for the first time. 1.

Plug the AC Adapter into an electrical service outlet.

2.

Connect the AC Adapter cord to the power connector on the rear of the instrument.

3.

Allow the battery to charge for at least eight hours. Note:

4.

The AC Adapter can remain connected all the time.

To ensure adequate charge, leave the instrument connected to the AC Adapter for a minimum of eight hours. This eliminates the risk of the instrument powering down during a test.

Fully charged batteries will allow the AVOXimeter 4000 to analyze blood samples continuously for up to 8 hours when the display is set at medium brightness. Battery power can be conserved by: ● ●

Note:

Reducing (or turning off) display backlighting (see page 19). Reducing the standby delay (see page 22). The batteries can suffer from a “memory effect” if they are charged before being completely discharged. For optimal battery performance, discharge completely when possible before charging them. The message “Battery Critical – Connect Charger” will be displayed when the battery is completely discharged.

The message “Battery Critical – Connect Charger” is displayed and the instrument reverts to the standby mode if the battery power is insufficient to complete the test. The AC Adapter must be used for additional tests until the battery is recharged. Checking the Battery:

18

1.

Display the “Time, Date, and Temperature” menu (a submenu of 12).

2.

Press

followed by

to display the battery status:

, see page

AVOXimeter 4000 Operator’s Manual

3.

Press

4.

Press

to display the time, date, and battery menu again. to return to the previous menu, if desired.

Setting Up the Instrument The user can specify the display brightness, specify the units that are used for reporting total hemoglobin (tHb), change the date and time, and specify the length of time that the instrument is idle before it enters the standby mode.

Setting Display Backlighting Lighting of the display can be reduced to conserve battery power or increased to improve visibility. , see page 12).

1.

Display the “Device Settings” menu (a submenu of

2.

followed by Press backlighting:

3.

Select the backlighting level (or turn it off) by pressing the corresponding number key followed by . The backlighting changes accordingly.

4.

Press

to display the screen for changing the LCD

to display the “Device Settings” menu again.

Specifying Units for Total Hemoglobin (tHb) Measured values of total hemoglobin can be expressed in units of mmol/L or gm/dL. 1.

Display the “Device Settings” menu (a submenu of

2.

followed by Press hemoglobin:

3.

Press followed by to change the units, or press followed by when the desired units are displayed. The “Device Settings” menu is again displayed.

4.

Press

, see page 12).

to display the screen for changing the units for total

to return to the previous menu, if desired.

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AVOXimeter 4000 Operator’s Manual

Enabling or Disabling Display of SO2, O2Ct, and O2Cap Display of calculated oxygen content (O2Ct), percent saturation (SO2) and oxygen carrying capacity (O2Cap) of the blood sample can be enabled or disabled. Oxygen content (O2Ct), percent saturation (SO2), and oxygen carrying capacity (O2Cap) are automatically calculated for each test.

Note:

When display of these values is enabled, these values are displayed on the second page (of three pages) when results are reviewed in the ‘stored data’ menu (see page 37), and they are included in printed test results. Only measured values of tHb, %HbO2, %COHb, and %MetHb are displayed on the instrument display panel after a test is run, regardless of whether display of calculated oxygen content (O2Ct), percent saturation (SO2), and oxygen carrying capacity (O2Cap) of the blood sample is enabled. ).

1.

Display the second page of the “Device Settings” menu (a submenu of

2.

followed by to display the screen for enabling or disabling display Press of calculated (O2Ct), (SO2), and (O2Cap) for each test:

3.

Select the appropriate option by pressing the corresponding number key followed by . A corresponding confirmation prompt is displayed.

4.

Press

to return to the previous menu, if desired.

Enabling or Disabling Suppression of Negative Values Users can choose to display or suppress negative values. Negative values may occur because in some cases, due to instrument precision ranges, a very low Met- or Carboxyhemoglobin value may read as a negative value. Users can choose to suppress negative values, and have them read as ‘0’.

Note:

1.

Display the second page of the “Device Settings” menu (a submenu of page 12).

2.

followed by Press of negative values:

3.

Select the appropriate option by pressing the corresponding number key followed

to display the screen for enabling or disabling display

by . A corresponding confirmation prompt is displayed. Press to the previous menu, if desired.

20

, see

to return