AVOXimeter 4000 Operators and Service Manual Rev 9.06

Table of Contents Topic General Precautions Introduction to the AVOXimeter 4000 System Components Getting Started Keypad Overview Installation and Operation Software Features Sample Collection and Preparation Sample Analysis Sample Printouts Settings Computer key Settings Main Menu key Settings Calibration and Quality Control Optical QC Filters Liquid QC Proficiency Testing Maintenance Theory of Measurement Troubleshooting Specifications Appendix A: Printer Information Appendix B: Menu Flowcharts Appendix C: ASTM Output Warranty and Service Appendix D: Circuit Diagrams Index

Rev 9.06

Page 3 4 5 7 8 9 10 12 13 15 16 16 23 28 28 30 31 32 35 37 42 43 44 51 55 56 61



General Precautions

2

!

1.

Do not allow untrained or an unauthorized personnel to use this instrument.

2.

This instrument will give accurate readings only if the cuvettes are at room temperaure and the temperature probe is near the cuvettes.

3.

Do not attempt to use this instrument outside the recommended temperature range: 15°C - 30°C (59°F - 86°F). Do not place this instrument in air currents or thermally unstable surroundings. Do not warm the cuvettes in your hand.

4.

Do not allow blood, water, or other liquids to enter the instrument itself.

5.

Cuvettes are not sterile. Blood exposed to the cuvette should not be returned to the patient.

6.

Do not re-use the cuvettes; discard after each use.

7.

Always keep cuvettes in sealed bag with desiccant.

8.

When filling cuvette, do not use excessive pressure or cause the vent patch to bulge outward. Do not insert a cuvette if the vent patch protrudes; discard it.

9.

Do not leave a cuvette in the oximeter. Remove the cuvette as soon as the sample has been analyzed.

10.

For proper calibration, use only the hemoglobin controls recommended in this manual. Controls from other sources yield erroneous results.

11.

Use this instrument only with the AC adapter (battery charger) supplied by ITC.

12.

Do not use this instrument in the presence of flammable agents or anesthetics.

13.

Operator should take appropriate precautions when handling potentially infectious blood samples. 

Introduction The AVOXimeter 4000 is intended for professional use in settings in which rapid, accurate measurements are needed of the total hemoglobin concentration and the relative concentrations of oxy-, carboxy-, and methemoglobin. Direct analyte values are obtained in 10 seconds. In addition, oxygen content (O2Ct) is automatically calculated and available on the printout and data output. The AVOXimeter 4000 is a light-weight, portable instrument that is calibrated at the factory prior to shipment. Optical technology (patent pending) and disposable cuvettes enable the AVOXimeter 4000 to make its measurements six to ten times faster than standard co-oximeters and eliminate the extensive care associated with their use. No sample preparation is required. Analysis is quickly accomplished by injecting the whole blood 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 absorbance of the sample at each wavelength, and computes the results. In 10 seconds, the total hemoglobin concentration and the relative concentrations of oxy-, carboxy- and methemoglobin are shown in appropriate units on the liquidcrystal display on the front panel. The total hemoglobin concentration measured by the AVOXimeter 4000 includes oxy-, deoxy-, met- and carboxyhemoglobin: tHb = [O2Hb] + [HHb]+ [MetHb] + [COHb] Accordingly, the percentage of oxyhemoglobin reported by the AVOXimeter 4000 is

%O2Hb =

[O2Hb] x 100 [O2Hb] +[HHb]+ [MetHb] + [COHb]

The fractions of carboxy- and methemoglobin are defined in a similar manner. In the U.S., the AVOXimeter is classified as "moderately complex" under the CLIA

NOTE test categorization.



System Components The AVOXimeter 4000 system consists of the following components: • AVOXimeter 4000

• AC adapter

• Single-use cuvette (ordered separately) • Temperature probe • Optical QC filters

• Operator's Manual

(yellow and orange)

• Printer (optional)

AVOXimeter 4000 (front view) Includes AC adapter and Operator's Manual (not shown)

AVOXimeter 4000 (rear view) showing handle, serial port, AC adapter port, and temperature probe (connected).



System Components (cont'd)

Optical QC filters

Cuvettes

Optional printer



Getting Started Precautions

1. Use only the AC adapter (battery charger) supplied by ITC, PN 9692 (110 VAC) or PN 9671 (220 VAC). 2. The instrument should not be used in the presence of flammable agents. 3. For accurate readings, the cuvettes must be stored at room temperature (15-30°C) near the temperature probe connected to the instrument. Do not place the instrument in air currents or thermally unstable surroundings. 4. Do not allow blood or other liquids to enter the instrument itself. 5. Blood exposed to the cuvette should never be returned to the patient because the cuvettes are not sterile.

A

B

Front Panel (A) Slot for cuvette insertion.

1

2

3

Cancel

(B) Keypad for data entry.

4

5

6

Yes +

7

8

9

No -

.

0

k

Print

Main Menu

Computer

(C) Liquid-crystal display or LCD. Sample#1 tHb O2Hb COHb 17.0 39.7 56.6 g/dL % %

The display has four lines, each with 20 characters.

MetHb 1.1 %

Enter/On

C Data Entry

Sample analysis does not require use of the numeric keypad until after the sample analysis is complete and prior to display of the results. After the analysis is complete, the software allows Sample Identification through selection or entry of numeric values. 

Keypad Overview Data Entry (cont'd)

Keypad

Other keys on the keypad are utilized as follows:

A

Main Menu provides access to a series of menus or options to configure Calibration, specify Printing options, view Stored Data, or Power Down the AVOXimeter 4000.

B

Computer provides access to a series of menus or options to enable Data Management features and configure Device Settings.

C

Enter/On accepts selections. When the screen presents a menu, press the appropriate number key to make your selection followed by the Enter/On key to accept your selection and proceed to the next screen.

D

Backspace [f] erases the character immediately to the left of the cursor. This key should be used when changing an operator-entered numeric string of characters.

E

Print prints a hard copy of the results to the attached external printer.

F

No/- moves back one record or setting in select functions.

G

Yes/+ moves ahead one record or setting in select functions.

H

Cancel returns to the previous menu.

1

2

3

Cancel

H

4

5

6

Yes +

G

7

8

9

No -

F

.

0

�

Print

E

Main Menu

Computer

A

B

Enter/On

D C 

Installation and Operation Installation

1. Place the AVOXimeter 4000 on a stable surface away from drafts. 2. Plug the AC adapter (PN 9692 for 110 VAC, 60 Hz, or PN 9671 for 220 VAC, 50 Hz) into an appropriate electrical outlet . 3. Plug the external temperature probe into the designated socket on the rear panel (see page 5). Ensure that the plug is firmly seated. 4. Place the box of disposable cuvettes next to the instrument's temperature probe. Prior to use, the bag of cuvettes must be stored near the temperature probe for a minimum of one hour at ambient room temperature. 5. Refer to Appendix A for printer information.

Operation

1. Turn on the instrument by pressing the Enter/On key. 2. Upon power-up, the AVOXimeter 4000 executes a self-test to confirm the proper operation of its light sources. If the self-test fails, the AVOXimeter 4000 will assist you in diagnosing the problem. For additional help, consult the Troubleshooting section of this manual. 3. If the AVOXimeter 4000 passes the self-test, then the yellow and orange optical filters may be analyzed to verify that its calibration has not changed. Each optical filter should be analyzed, at a minimum, once each day the AVOXimeter 4000 is used to report patient results. 4. If the optical filter readings are all within the established ranges, then the system is ready to analyze patient samples (refer to page 13 for details). If any of the values are outside of the ranges, refer to the Troubleshooting section.

Powering Down

1. To turn the AVOXimeter 4000 off, press the Cancel and Main Menu keys simultaneously. 2. The AVOXimeter 4000 can also be turned off by pressing the Main Menu key and selecting the Turn Off option. 

Software Features The software in the AVOXimeter 4000 has been specifically designed to facilitate sample analysis yet provide optional features to assure result integrity for patient reporting and to facilitate regulatory compliance. All operating parameter settings are stored in non-volatile memory and are retained when the AVOXimeter 4000 is powered down.

Security

Enabling the Security feature requires entry of a valid numeric User ID before performing tests or accessing data in the AVOXimeter 4000. These numeric User IDs must be predefined by the QA User through the Data Management Menu, User ID option. Enabling the Security feature also provides the option to suppress printing of the User ID on the result printout. When the option to print the User ID is disabled, a labeled line on the printout provides space for writing in the User ID manually.

User ID

When Security is disabled, a User ID option allows entry of a nonvalidated numeric operator ID. This eliminates the need to enter a valid User ID before accessing functions on the AVOXimeter 4000 and satisfies regulatory requirements for recording the operator who performed the test. Because these IDs are not secure, using this mode for recording operator IDs automatically includes the User ID on the printout. Disabling the User ID completely bypasses the User ID entry option.

Sample Identification

The software requires the operator to distinguish between a patient and QC sample prior to result display. When Security is disabled, following completion of sample analysis, the AVOXimeter 4000 guides the operator through entry or selection of the following information about the sample just analyzed: A. Operator ID, if User ID is enabled. B. Sample type, either Patient or QC 1. If the sample type is patient, the patient ID, if enabled. 2. If the sample type is QC, the type of QC, either optical or liquid. a. If the QC type is optical, the Yellow or Orange filter b. If the QC type is liquid, the level, the material lot(s) predefined for the level, and verification of the predefined Cuvette Lot number or entry of the new Cuvette Lot number. 10

Software Features (cont'd)

Default Settings

The AVOXimeter 4000 is shipped from the factory with the following default settings:

User ID

Off

Security

Off

Patient ID

Off

Data Transfer

Off

Auto Print

Off

Printer Baud Rate

9600

Printer Parity

None

Standby Delay

30 min.

Backlight

MEDIUM

tHb units

g/dL

Hüfners Number

1.39

Please refer to the Settings section of this manual for additional options and instructions to modify the above settings or define values for data entry that cannot be established at the factory, such as Cuvette Lot number, QC Material Lot numbers, and Cuvette Cal Code.

11

Sample Collection and Preparation Sample Collection

To obtain accurate measurements, collect blood samples in a sodium or lithium heparinized plastic syringe. Collect and handle the specimens according to medically-accepted sterile techniques, including the use of universal precautions.

Collection Sources of error

1. When drawing blood samples with a syringe from a saline-filled catheter, withdraw the saline first and make sure that only whole blood is sampled. 2. Citrate is known to change the pH of the blood and cause errors in spectrophotometric measurements. Similarly, fluoride and oxalate should be avoided. 3. Excessive volumes of anticoagulant or saline may oxygenate the sample or cause dilution errors.

Sample Preparation

1. Roll the tightly sealed syringe between your palms to keep the red blood cells and plasma well mixed. Poorly mixed samples or those containing clots may cause inaccurate results. 2. When handling cuvettes, hold them only by their black caps. 3. To avoid warming the cuvette, do not pick it up until you are ready to fill it and analyze the sample. 4. Always fill cuvette prior to inserting it into the instrument.

Preparation Sources of error

1. Always store cuvettes in the sealed bag with a desiccant pouch or erroneous results may occur. Check the desiccant prior to using cuvettes to ensure that the color indicator has not changed from blue to pink. If the color indicator has changed, do not use cuvettes until a new desiccant pouch can be added to the bag. Prior to use, verify indicator is blue. 2. When filling a cuvette, do not use excessive pressure or cause the vent patch to bulge outward. If the vent patch protrudes, discard the cuvette. To avoid contaminating the optics, never insert a cuvette with a protruding vent patch into the instrument. 3. If the sample in the cuvette is poorly mixed or contains clots, then discard the cuvette to prevent erroneous results. 12

Sample Analysis 1. Confirm that the temperature probe is plugged firmly into its socket on the rear panel of the instrument. Press the Enter/On key to turn on the AVOXimeter 4000 and confirm that the self-test was successful. The instrument is ready to analyze samples when the display reads:

- - R E A D Y - - I n s e r t C u v e t t e Ready Screen C a l C o d e = 4 4 4 4 5 2. Verify that the Cal Code is correct for the cuvette bag in use. If not, refer to page 23. 3. Collect and prepare the heparinized blood sample as described on page 12 or prepare the control sample as described on the package insert for the control.

Hold cuvette by black cap Bubble here is OK

Light Path Vent patch

Side View (Do not let patch bulge)

13

Sample Analysis (cont'd)

4. Expel one drop of sample from syringe and connect sample-filled, plastic syringe to a new disposable cuvette. 5. Hold cuvette downward at 45° angle and inject sample into cuvette until sample reaches the vent patch at the opposite end. Leave the syringe attached to the cuvette. CAUTION!

Never force sample into cuvette. If cuvette does not fill easily, discard it and use another one. 6. Confirm that the light path at the widest portion of the sample chamber is free of debris or air bubbles. Ignore bubbles outside of the light path (see page 13). 7. Remove any blood on cuvette's exterior surfaces before inserting cuvette into the AVOXimeter 4000. Do not overpressure the cuvette or cause the vent patch to bulge outward. 8. Insert cuvette within 10 seconds of filling it.

CAUTION

Never inject blood or any other material into the instrument itself. 9. Observe the LCD display. At the screen prompt, remove the cuvette and select the sample type. 10. After the sample information is entered, the results will be displayed as follows:

S a m p l e # 1

NOTE

t H b 1 7 . 0

O 2 H b 3 9 . 7

C O H b 5 6 . 6

g / d L

%

%

M e t H b 1 . 1 %

11. After the results appear, the data will stay on the display until the Enter/On key is pressed. Data will be stored in non-volatile memory (100 samples) and may be recalled using the Stored Data menu. 12. To analyze the next sample, obtain a fresh cuvette from the bag next to the instrument, and repeat the previous eleven steps. 14

Sample Printouts Liquid QC with User ID On

Optical QC with User ID On

Optical QC with User ID Off

AVOXimeter 4000 Liquid QC Test S/N: 41017

AVOXimeter 4000 Optical QC Test S/N: 41017

AVOXimeter 4000 Optical QC Test S/N: 41017

Tested on 05/24/05 07:43

Tested on 05/24/05 07:43

Tested on 05/24/05 07:43

Test Number 390 975310 2 754191

tHb O2Hb COHb MetHb

14.1 94.5 2.3 1.0

O2Ct

18.6

Test Number 392

Test Number 393

User ID Control Level QC Lot Number Measured

Calculated

Cal. Code Cuvette Lot

User ID Optical Filter

975310 Orange

g/dL % % %

tHb O2Hb COHb MetHb

17.0 39.3 21.3 1.0

mL/dL

O2Ct

9.3

41878 103095

Measured

g/dL % % %

Calculated

mL/dL

Not Entered Yellow

tHb O2Hb COHb MetHb

8.0 95.2 1.6 0.7

O2Ct

10.5

Measured

g/dL % % %

Calculated

mL/dL

__________________________________ User ID

A-VOX Systems, Inc.

A-VOX Systems, Inc.

User ID Optical Filter

A-VOX Systems, Inc.

Liquid QC with User ID Off

Patient ID On & User ID On

Patient ID Off & User ID On

AVOXimeter 4000 Liquid QC Test S/N: 41017

AVOXimeter 4000 Patient Test S/N: 41017

AVOXimeter 4000 Patient Test S/N: 41017

Tested on 05/24/05 07:43

Printed on 05/27/05 09:03

Tested on 05/24/05 07:43

Test Number 391

Tested on 05/24/05 07:43

Test Number 395

User ID Control Level QC Lot Number tHb O2Hb COHb MetHb O2Ct

14.1 94.5 2.3 1.0 18.6

Not Entered 2 754191 Measured

Calculated

Cal. Code Cuvette Lot

g/dL % % %

A-VOX Systems, Inc.

User ID Patient ID

864201 357912468035

mL/dL

tHb O2Hb COHb MetHb

12.5 95.0 2.3 0.3

41878 103095

O2Ct

16.5

__________________________________ User ID

User ID Patient ID

Test Number 394

Measured

Calculated

Cal. Code

g/dL % % % mL/dL 41878

__________________________________ Patient Name A-VOX Systems, Inc.

975310 Not Entered

tHb O2Hb COHb MetHb

12.4 95.4 1.9 0.2

O2Ct

16.5

Measured

Calculated

Cal. Code

g/dL % % % mL/dL 41878

__________________________________ Patient Name __________________________________ Patient ID A-VOX Systems, Inc.

15

Settings The Computer and Main Menu keys activate the configuration and data access features of the AVOXimeter 4000. The following section describes the options available from these keys. For a quick reference, Appendix B contains a hierarchy of the configuration menu structure. Options under the Main Menu key begin on page 23.

Computer

When the Computer key is pressed, the following menu is displayed: 1. Data Management 2. Device Settings 3. Time,Date,Temp

Data Management

Selection of choice 1 from the Computer menu displays the Data Management menu options: 1.Data TransferON/OFF 2.User ID ON/OFF 3.Patient ID ON/OFF 4. QC Lot

Data Transfer

The purpose of this feature is to provide the option to send the AVOXimeter's data out the serial port using both the ASTM format and communication protocol. Selection of this option displays the current status (On or Off) and allows the operator to leave the status as currently displayed or select the alternate status.

ON

When ON, option ‘3. Transfer Data’ appears on the Stored Data menu. Selecting the Transfer Data option from the Stored Data menu, sends result records out the serial port via the attached RS232 cable, using the ASTM Standard Specification for Transferring Information Between Clinical Instruments and Computer Systems, E1394-91, as it applies to the specific data generated by the AVOXimeter 4000 and the ASTM Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems, E1381-91. 16

Computer Settings (cont'd) Data Transfer (Cont'd)

ON

Please refer to Appendix C for output format specific to data generated by the AVOXimeter 4000. The output contains a flag indicating that a record has been previously sent.

OFF

When OFF, option ‘3. Transfer Data’ no longer appears on the Stored Data menu and disables the ability to transfer results to another device such as a computer.

User ID

The purpose of this feature is to allow optional entry of the operator ID in either a secure or non-secure mode. Selection of this option displays the current status and allows the operator to leave the status as currently displayed or select the alternate status.

ON

When User ID is turned ON or the current ON status is acknowledged, the operator is presented with the Security ON/OFF menu. Please see the following section for a discussion of the Security options. When the User ID is ON and Security is OFF, the operator of the AVOXimeter is prompted for entry of the User ID at the completion of sample analysis, but prior to the results display. In this configuration, the AVOXimeter 4000 accepts either a validated or non-validated User ID or no User ID. Leaving the User ID blank displays ‘USR Not Ent.’ on the Stored Data result display. Leaving the User ID blank prints ‘User ID Not Entered’ on the result printout and provides a blank line for writing in the User ID manually.

OFF

When User ID is OFF, the operator is not given the option to enter User ID following the completion of sample analysis. A sample analyzed with User ID OFF displays ‘USR Not Ent.’ on the Stored Data result display, prints 'User ID Not Entered’ on the result printout, and provides a write-on capability at the bottom.

Security

The purpose of this feature is to require entry of a valid numeric User ID before allowing access to the AVOXimeter 4000 functions. Selection of this option displays the current status and allows the operator to leave the status as currently displayed or select the alternate status.

NOTE

Following five minutes of inactivity, the AVOXimeter 4000 automatically returns to the Enter User ID screen when Security is ON.

17

Computer Settings (cont'd) Security (Cont'd)

ON

When Security is turned ON or the current ON status is acknowledged, the following menu is displayed: 1. Review/Delete 2. Add User 3. Print User List 4. Print ID ON/OFF

Review/Delete

This option displays a list of secure User IDs. The numeric User ID for the QA User which never displays or prints is 123456. The literal ‘QAUSER’ prints or displays in place of 123456. Though the screen display includes the option to 'Delete This ID', the ID for the QA User cannot be deleted. An attempt to delete this ID results in an error message. Cancel or option ‘1. Return to PrevMenu’ returns to the previous menu. Option ‘2. Delete This ID’ presents a confirmation screen to confirm deletion of the ID unless it belongs to the QA User. Yes/+ displays the next secure numeric User ID. No/- displays the previous secure numeric User ID.

Add User

This option allows entry of a new numeric User ID from one to nine digits in length. If the User ID entered already exists, a message is displayed and the User ID is not added. If the User ID does not already exist, it is added to the list of secure User IDs.

NOTE

The AVOXimeter 4000 allows definition of 50 secure User IDs. An attempt to add more than 50 secure User IDs results in an error message.

Print User List

If an external printer is connected, this option prints a list of secured User IDs currently defined in the AVOXimeter 4000.

18

Computer Settings (cont'd)

Print ID

This feature determines if the secured User IDs print on the result printout. Selection of this option displays the current status and allows the operator to leave the status as currently displayed or select the alternate status.

ON

When ON, the secured User ID prints on the printout.

OFF

When OFF, and Security is ON, the secured User ID does not print on the printout, rather the printout includes User ID write-on capability at the bottom. When Security is turned OFF or the current OFF status is acknowledged, entry of a valid numeric User ID is no longer required to operate the AVOXimeter 4000. When Security is turned Off, User IDs will be printed on the result printout for both new and recalled tests.

Patient ID

ON

The purpose of this feature is to allow optional entry of the patient ID. Selection of this option displays the current status and allows the operator to leave the status as currently displayed or select the alternate status. When Patient ID is ON, the operator of the AVOXimeter is prompted to enter the Patient ID at the completion of sample analysis, but prior to the results display. In this configuration, the AVOXimeter 4000 accepts entry of a one to twelve digit numeric Patient ID. Leaving the Patient ID blank displays ‘Pt. ID: Not Entered’ on the Stored Data result display, prints ‘Patient ID Not Entered’ on the result printout and provides a write-on capability at the bottom.

OFF

When Patient ID is OFF, the operator is not given the option to enter Patient ID following the completion of sample analysis. A sample analyzed with Patient ID OFF displays ‘Pt. ID: Not Entered’ on the Stored Data result display, prints ‘Patient ID Not Entered’ on the result printout and provides a write-on capability at the bottom.

19

Computer Settings (cont'd) QC Lot

The purpose of this feature is to allow definition of the QC Lot Number(s) associated with Levels 1, 2, or 3 once they have been accepted for use within the organization. Following completion of sample analysis, but before result display, the operator is asked to identify the sample type. If the sample type is Liquid QC, the screen for Level selection appears, followed by the Lot Numbers predefined using this feature for the selected level. This feature allows for definition of three lot numbers per level. During sample identification, only those previously defined will appear for operator selection.

Select Level

Following selection of the QC Lot option, the following menu appears. Select Level: 1. Level 1 2. Level 2 3. Level 3

Select Lot

The lot numbers defined for the level selected are displayed. Select the Lot number to be changed or deleted. The QC Lot confirmation screen displays the Lot Number selected. Option 1. Cancel or OK to accept the Lot Number displayed. Option '2. Enter New Value' presents a Lot Number entry screen. Enter a new Lot Number from one to seven numeric digits in length or press Enter/On to delete the previous Lot Number. Entry of a new Lot Number requires confirmation. Deletion of a Lot Number automatically shifts the remaining Lot Numbers up one selection on the Select Lot screen. When specifying Lot Numbers, ignore leading letters and leading zeroes.

Device Settings

Selection of choice 2 from the Computer menu displays the following Device Settings menu: 1. LCD 2. Units 3. Standby Delay 20