Triage MeterPro User Manual rev A

User Manual

104 Pages

File Type: PDF

File Size: 23.1 MB

File Name: triage_meterpro_user_manual_rev_a_.pdf

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Page 1

Triage®

MeterPro User Manual

Triage

MeterPro User Manual Table of Contents Introduction

Operation

How to Use This Guide. . . . . . . . . . . . . . . . . . . . 2

Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Run Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

Description . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Purpose. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

Unpacking. . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

QC Device. . . . . . . . . . . . . . . . . . . . . . . . . 44

Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . 8

QC Sample. . . . . . . . . . . . . . . . . . . . . . . . 46

Test Device Specifications. . . . . . . . . . . . . . . 8

Patient Sample . . . . . . . . . . . . . . . . . . . . . 48

Warnings, Precautions and Limitations . . . . . . . 9

Misc. Test. . . . . . . . . . . . . . . . . . . . . . . . . 51 Recall Results. . . . . . . . . . . . . . . . . . . . . . . . . . 53

Installation

Last Record. . . . . . . . . . . . . . . . . . . . . . . . 53

Installation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Patient Results . . . . . . . . . . . . . . . . . . . . . 54

Set Parameters. . . . . . . . . . . . . . . . . . . . . . . . . 20

QC Results . . . . . . . . . . . . . . . . . . . . . . . . 61

List of Programmable Parameters . . . . . . . . 20

Reagent Lots–QC. . . . . . . . . . . . . . . 67

Supervisor Access . . . . . . . . . . . . . . . . . . . . 20

Archive Last Test. . . . . . . . . . . . . . . . 67

How to Set Parameters: Basic Instructions. . . . 21

Misc. Test Results. . . . . . . . . . . . . . . . . . . 68

Meter Settings. . . . . . . . . . . . . . . . . . . . . . . . 21

Print all Results. . . . . . . . . . . . . . . . . . . . . 74

Communication Settings. . . . . . . . . . . . . . . . 28

Delete Results. . . . . . . . . . . . . . . . . . . . . . . . . . 76

Clock. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Display Backlight. . . . . . . . . . . . . . . . . . . . . . . . 78

User ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

Alpha Numeric Mode . . . . . . . . . . . . . . . . . . . . 79

Ranges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 Test Settings. . . . . . . . . . . . . . . . . . . . . . . . . 36

Care & Maintenance

QC Parameters. . . . . . . . . . . . . . . . . . . . . . . 38

Total Quality Assurance . . . . . . . . . . . . . . . . . . 80

Bypass. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

Service and Maintenance Procedures . . . . . . . 85

Install CODE CHIP module. . . . . . . . . . . . . . . 40

Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . 88

™

Return and Disposal Procedure. . . . . . . . . . . . 91

Appendix Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93 Software Flowchart. . . . . . . . . . . . . . . . . . . . . . 95 Labeling Symbols. . . . . . . . . . . . . . . . . . . . . . . 96 Sample Log Sheets. . . . . . . . . . . . . . . . . . . . . . 97 Contact Alere . . . . . . . . . . . . . . . . . . . . . . . . . 100 Limited Warranty. . . . . . . . . . . . . . . . . . . . . . . 101

How to Use This Guide This manual contains: • Instructions for the operation and maintenance of the Alere Triage® MeterPro, and; • Basic instructions for testing samples

Note: To run specific tests, such as the Alere Triage® Cardiac Panel, you also will need detailed information contained in the product-specific package insert, included in the test kit.

The Alere Triage® MeterPro software has been designed to provide the user step by step instructions. The meter displays test results and menu options in the upper half of the meter screen. In smaller letters at the bottom of each screen, the meter displays instructions pertaining to the task being performed. 8:23AM 01•20•11

RUN TEST RECALL RESULTS INSTALL NEW CODE CHIP SELECT WITH v OR ^ AND PRESS ENTER PRESS EXIT TO EJECT DEVICE The display above is the Main Menu and appears after the meter has been turned on and completed an automatic self-test.

The Alere Triage MeterPro User Manual is divided into five sections. ®

Section 1 – Introduction: Provides an overview of Alere Triage® MeterPro. Section 2 – Installation: Guides the user through first time setup. Section 3 – Operation: Guides the user through running tests, recalling results and deleting results. Section 4 – Care & Maintenance: Total Quality Assurance, Warnings, Precautions and Limitations, Service and Maintenance, Warranty. Section 5 – Appendix: Troubleshooting, Sample Log Sheets, Index of Page Revisions, Certificate of Conformity, Software Flowchart, Glossary

Symbols

Meter Keys are indicated by

= Caution

= Up key

= Down key

= Important

= Left key

= Right key

= Note

= On/Off key

= Delete key

= Brightness key

= Shift key

= Symbol key (used with Shift key)

= Print key

= Paper Feed key

= Enter key

= Exit key

Screen commands and options are indicated by a Bolded Font.

Introduction Description

What is the Alere Triage MeterPro? ®

The Alere Triage® MeterPro is a portable fluorescence instrument used to measure the results of tests manufactured by Alere San Diego, Inc. The Alere Triage® MeterPro can be used in a laboratory or in a point-of-care setting. The Alere Triage® MeterPro uses a laser as a light source. Light from the laser hits a test device that has been inserted in the meter. This causes the fluorescent dye in the test device to give off energy. The more energy the fluorescent dye gives off, the stronger the signal.

Alere Triage® Test Devices. A test device holds the sample and also contains the reagents and other materials needed for the test.

Overview: Running a Test After a test sample (for example, blood) from a patient is added to the test device, the test device is inserted in the Alere Triage® MeterPro. The meter measures how much of the substance (a particular protein marker) is present, based on standards that have been preprogrammed into the meter. The patient identification, the User I.D. and the test results can be printed out on a paper tape.

In addition to testing samples from patients, the Alere Triage® MeterPro contains preprogrammed Quality Control (QC) functions that allow the person operating the meter to monitor quality control.

Unpacking The Alere Triage® MeterPro and the items that come with it are provided in a single box. Alere Triage® test devices are packaged separately and include instructions for running specific tests. If you have any questions, contact Alere (refer to the Contact Alere section). Contents: • Alere Triage® MeterPro • QC Device & CODE CHIPTM module (in the QC Device box) • AC / DC Power Converter • AA Batteries • Rolls of Printer Paper (additional rolls are supplied in each box of test devices) • Supervisor CODE CHIPTM module & CODE CHIPTM module Box

Printer paper located below QC Device Box

Note: The Alere Triage® MeterPro accepts test devices that are designed specifically for use with the Alere Triage® MeterPro. Please refer to product-specific package inserts included in each test kit for more information.

Parts of the Alere Triage® MeterPro Thermal Printer

LCD (liquid crystal display)

Printer cover

Backlight

Delete

Power button

Test device insertion port

Battery cover

Printer cover

Power supply port

Data port

CODE CHIP

module port

Power button

Used to turn the Alere Triage® MeterPro on and off.

Print Button

Used to print the test results or display screen.

Delete Button

Used to delete data.

Enter Button

Allows the operator to select menu items and acknowledge alarm conditions.

Exit button

Used to exit the displayed menu or eject the test device.

Keypad

Used to enter identification numbers, letters, and special symbols.

Arrow Buttons

Used to toggle through menu items.

Thermal Printer

Prints the test result on paper.

Data Port

Connection point for the (optional) Bar Code Scanner, allowing the operator to scan patient or user identification data instead of manually entering numbers or letters on the keypad. May also be used to connect to a data management system/LIS.

CODE CHIPTM module Port

Insertion point for CODE CHIPTM modules which contain lot / device specific data for use in providing test results.

Power Supply Port

Connection point for the supplied AC / DC Power Converter.

Printer Cover

The cover, which when pulled straight up, reveals the paper roll.

LCD Screen

The LCD (Liquid Crystal Display) Screen shows the menu of possible tests and tasks and prompts the operator to take the next step.

Specifications Physical Size

8.5” x 6.25 “x 2.75” (22.5 cm x 19 cm x 7 cm) D x W x H

Weight

1.5 pounds (0.7 kg) without batteries

Electrical

6v DC at 1 amp – supplied via 4 AA batteries or AC/DC Converter

Keypad

Numeric with special function keys (22 total)

Environmental Temperature

15°C – 30°C

Humidity

10% – 85%

Location

Dry, clean, flat horizontal surface away from direct sunlight

Optical Light Source

Laser Diode – <1 milliwatt

Detector

Silicone Photodiode

Memory Capacity 750 Patient Records

32 Reagent Lot CODE CHIPTM modules

200 QC Sample Results

200 QC Sample CODE CHIPTM modules

70 QC Device Results

4 QC Device CODE CHIPTM modules

250 Misc Test Results 600 User ID’s Miscellaneous RS-232 computer interface port Thermal Printer LCD screen display Options • External Bar Code Reader (rapid entry of User, Patient, Auxiliary or Misc Test ID’s). • Alere Triage Census® Data Management Software. • Alere Triage Census® Data Management Software with LIS Connectivity. Test Device Specifications Test device specific information is provided in the applicable product insert. The instrument analyzes immunoassay test devices manufactured by Alere San Diego, Inc.

Warnings, Precautions and Limitations • Operate the Alere Triage® MeterPro on a level, dry surface away from direct sunlight. • The QC Device is light-sensitive and should be stored in its black opaque case when not in use. • Do not move the Alere Triage® MeterPro while a test is in progress. • Ensure all sample fluids have absorbed into the test device prior to running the test to prevent internal contamination of the meter. • Use only the AC/DC power adapter provided with the Alere Triage® MeterPro. An identifying tag has been placed on the cord for quick identification. • Do not drop the Alere Triage® MeterPro. • Do not place objects on the Alere Triage® MeterPro. • Do not immerse the Alere Triage® MeterPro in water or any liquids.

(Intentionally blank)

Installation 1. Unpack Meter: a. Remove the meter from the box and protective plastic bag.

2. Power Meter On:

Batteries a.

Turn the meter over.

Remove battery cover.

Install 4 AA batteries, paying attention to battery orientation in the battery compartment.

d. Replace battery cover and turn meter right side up. e. Power the meter on by pressing the

key. Press the

key to run self-test.

When the test is completed, the meter display screen will come to rest at the main menu. 8:23AM 01•20•11 Low Power Indicator

Time and date

RUN TEST RECALL RESULTS INSTALL NEW CODE CHIP

Menu items

SELECT WITH v OR ^ AND PRESS ENTER PRESS EXIT TO EJECT DEVICE

User instructions

The Main Menu

AC Power Supply a.

Remove the power supply from the box.

Plug one end into an AC outlet.

Plug the opposite end into the round hole in the back of the meter.

Note: The Low Power Indicator monitors the active power source. To verify adequate battery power: • Navigate to the Main Menu • Remove the AC power supply • Press the EXIT key (the meter attempts to eject a device) • Observe the Main Menu on the meter’s display. Replace the batteries if the power icon is visible.

For more details about Installing Paper see the

Care & Maintenance section.

3. Install paper: a. Remove the printer cover by pulling up on the cover as indicated by the arrow on the back of the cover.

b. Tear or cut a clean, straight edge to feed into the printer. Do not cut paper at an Note: The printer contains a paper sensor and will feed the new paper roll only when paper with a clean straight line is pressed into the paper roller.

angle, as the printer must sense the edge of the paper along the feed path.

c. Position the paper such that the paper will feed from under the roll (as opposed to over the top of the roll, see picture).

d. Insert the paper edge under the paper roller (platen) until it firmly seats or resistance is felt. e. Press the

key twice, paper will feed through the printer and extend

out the meter. f. Place the roll of paper into the paper compartment. g. Replace the printer cover and continue operation.

4. Insert Supervisor Code Chip module: a. Remove the Supervisor CODE CHIP module Box from the meter box. TM

b. Remove the Supervisor CODE CHIPTM module from its box. c. Insert the Supervisor CODE CHIPTM module into the CODE CHIPTM module Port. The port is located on the left side of the meter, towards the bottom front corner. Note the orientation of the CODE CHIPTM module in the drawing below. d. Once the Supervisor CODE CHIPTM module is installed, verify that two additional menu items appear on the display screen.

8:23AM 01•20•11 Two additional menu options accessible when Supervisor CODE CHIPTM module is inserted.

RUN TEST RECALL RESULTS INSTALL NEW CODE CHIP SET PARAMETERS DELETE RESULTS SELECT WITH v OR ^ AND PRESS ENTER PRESS EXIT TO EJECT DEVICE The Supervisor’s Main Menu

CODE CHIPTM module

CODE CHIPTM module port

For more details about CODE CHIPTM modules see page 19.

For more details about Meter Settings see page 21.

5. To Change Meter Settings: a. Select Set Parameters using the

keys and press the

key.

b. Select Meter Settings using the

keys and press the

key.

c. Select ID Settings, Display Settings or Comm Settings using the

keys and press the

key.

d. Select the desired setting using the setting by using the

ID Settings Characters User ID Characters Pat. ID Characters Aux ID Characters Misc ID Aux. ID Enable/Disable

keys and change the value of the

keys.

Default

Options

Min 1

1-16

Max 16

1-16

Min 1

1-20

Max 20

1-20

Min 1

1-12

Max 12

1-12

Min 1

1-20

Max 20

1-20

Disabled

Disabled, Enabled

New Settings

For reference, record your settings in the space provided.

e. Press the

key to save changes to ID Settings.

Display Settings

Default

Options

New Settings

Language

English

English, French, Italian, German, Spanish, Portuguese, Greek, Danish, Swedish, Japanese

Print Mode

Automatic

Automatic, Manual

Auto Power-Off

2 hour

1/2 hour, 1 hour, 2 hour, 4 hour, None

Display Contrast

0-8 (8=heaviest contrast)

Printer Contrast

0-8 (8=heaviest contrast) For reference, record your settings in the space provided.

f. Press the

key to save changes to Display Settings.

COMM Settings

Default

Options

New Settings

Baud Rate

38400

9600, 38400

Pat. Result Approval

Disabled

Enabled, Disabled

LIS Enable/Disable

Disabled

Disabled, Enabled

Auto Upload

Disabled

Disabled, Enabled

LIS Password

g. Press the

key to save changes to Communication Settings.

h. Press the

key to save changes to Meter Settings.

For more details about Communications, including entry of an Alere provided, meter specific password, see page 28.

For more details about Clock Settings see page 31.

6. Change Clock: a. Select Set Parameters using the b. Select Clock using the

keys and press the keys and press the

c. Select the Hour : Minute area using the

key.

keys. Type in the correct time

using the number keys. d. Press the

key to move to AM or PM.

e. Select AM or PM using the f. Press the

keys.

key to move to Time Format.

g. Select AM/PM or 24 HR. using the

keys. If selecting 24 HR.,

the previously entered Hour : Minute will change to a 24-hour format and the AM or PM will disappear. h. Press the

key to move to the Date.

i. Type in the 6-digit date according to the Date Format below it. j. Press the

key to move to the Date Format.

k. Select MM-DD-YY, DD-MM-YY or YY-MM-DD using the

keys.

The previously entered Date changes as the Date Format changes. l. Press the

key to save changes.

Setting

Default

Options

Time Format

AM / PM

AM / PM; 24HR

Date Format

MM-DD-YY

MM-DD-YY, DD.MM.YY, YY-MM-DD

New Settings

7. Set User ID:

The Alere Triage® MeterPro normally requires a User ID to be entered prior to running a patient test, QC test, or Misc test, and prior to recalling patient results. Refer to page 32 for instructions. Alternately, this feature may be bypassed. See page 18.

8. Change Reference Ranges / Thresholds for Tests: a. Select Set Parameters using the b. Select Ranges using the

keys and press the keys and press the

c. Select the test panel type using the

For more details about Ranges Settings see page 35.

key.

Note: The lowest

keys.

d. Select the analyte and level using the

keys. Type in the new value for

the High or Low cutoff as appropriate. e. Press the

value of the Range or Threshold may be disabled for some test panels. Refer to the appropriate Product Insert for specific information.

key to save changes.

9. Change Test Settings: a. Select Set Parameters using the b. Select Test Settings using the

keys and press the keys and press the

c. Select the test panel type using the d. Select the analyte using the

key. key.

keys. keys.

e. Select the test setting (ACTIV, INACT, USR A, or USR I) using the f. Press the

10.

For more details about Test Settings see page 36.

keys.

key to save changes.

Note: The ability

Change QC Parameters:

a. Select Set Parameters using the

keys and press the

key.

b. Select QC Parameters using the

keys and press the

key.

c. Select the desired setting using the

keys and change

the value to the right of the setting by using the

keys.

Setting

Default

Options

QC Device Freq.

Daily

None, 8HR, Daily, Weekly, Monthly

QC Sample Freq.

Monthly

None, 8HR, Daily, Weekly, Monthly

Number of Controls

1 or 2

Num Quant Std Devs

2 or 3

d. Press the

to change test settings may be disabled for some tests in specific panels. Refer to the appropriate Product Insert for specific information.

New Settings

key to save changes to QC Parameters.

For more details about QC Parameters Settings see page 38.

For more details about Bypass Settings see page 39.

11.Change Bypass settings: a. Select Set Parameters using the b. Select Bypass using the

Note: If the bypass is ON, the user ID feature is disabled and anyone may run a test. If the bypass is OFF, the user ID feature is active and only authorized users may run a test. To Install User ID’s, see page 32.

keys and press the keys and press the

c. For User ID select On or Off using the d. Press the

key.

keys.

key to save changes to the Bypass setting.

12.Prior to commencing patient testing, remove the Supervisor CODE CHIP module from the meter, return it to the storage box and place TM

in a safe place for future use. The meter is now ready to run QC Tests in preparation for Patient Testing. QC Testing should be performed in the following manner: 1. Run QC Device (see page 44). 2. Run QC Sample for each lot of devices (see page 46). 3. If appropriate, run Calibration Verification Set as a Misc Test sample for each test panel type to be used. (Refer to the applicable Procedure Manual and Calibration Verification Set Package Insert for detailed instructions).

Location The Alere Triage® MeterPro should be placed on a dry, clean, flat, horizontal surface away from direct sunlight.

Power The Alere Triage® MeterPro requires 6-volts DC supplied by either AC or DC. The meter Note: The Alere Triage® MeterPro will automatically turn off if left unused for 2 hours, unless programmed otherwise by the supervisor. Optional settings allow automated turnoff after 1/2 hour, 1 hour, 2 hours, 4 hours or NONE.

will run approximately 100 tests on batteries. It is recommended to use batteries as a backup in the event of a power outage.

Caution: Use only the power supply provided with the meter, failure to do so may cause permanent damage to the meter.

Self-Test The Alere Triage® MeterPro checks the system to verify it is operating properly by running self-tests when powered on and prior to each test. • Power On – includes laser operation, internal standard range, battery power, and software verification. • Each Test – verifies the laser operation, internal standard range and battery power.

CODE CHIPTM modules Meter data is updated via a disposable CODE CHIPTM module. The CODE CHIPTM module contains microchip circuitry embedded into a plastic housing. When inserted into the meter CODE CHIPTM module port and activated, the information is transferred into the Alere Triage® MeterPro’s memory. A CODE CHIPTM module typically needs to be installed only once and remains in the meter memory. A CODE CHIPTM module does not need to remain in the meter while performing tests. There are five types of CODE CHIPTM modules which can be distinguished by shape or color.

Standard CODE CHIPTM module •

Reagent Test CODE CHIPTM module– included in each box of test devices; contains calibration, expiration date and other data about the device lot. (Color varies by test type.)

•

QC Sample CODE CHIPTM module – included in each box of QC Sample; contains expiration date and other data about the QC Sample lot including acceptable range. (White)

•

QC Device CODE CHIPTM module – included in the black QC Device box (comes with the Alere Triage® MeterPro); contains data about how the meter should read its matching QC Device. (Dark gray.)

•

Supervisor Access CODE CHIPTM module – included with each Alere Triage® MeterPro; contains code to activate Supervisor functions. (Light gray.)

Software Upgrade CODE CHIPTM module •

Software Upgrade CODE CHIPTM module – provided when Alere Triage® MeterPro software upgrades are available; contains new software for the meter.

Set Parameters Purpose The Set Parameters function allows the supervisor to select a number of settings. Access to these settings is controlled using the Supervisor CODE CHIPTM module.

List of Programmable Parameters A supervisor can set the following parameters:

Heading

Parameters

Meter Settings ID Settings

Number of Characters in User ID, Number of Characters in Patient ID, Number of Characters in Auxiliary ID, Enable or Disable Auxiliary ID, Number of Characters in Misc Test ID

Display Settings

Language, Printer Mode, Auto Power-Off, Display Contrast, Printer Contrast

Communications

Baud Rate, Enable or Disable LIS, Enable or Disable Auto Upload, Enable or Disable Patient Result Approval

Clock

Time, Date, and Display Format

User ID

Add New User ID, Update User ID, Delete User ID or User ID List

Ranges

Test Cutoffs

Test Settings

Block Analytes

QC Parameters

Minimum Frequency for QC Tests, Number of Controls, Number of Standard Deviations (Quantitative Tests)

Bypass

Disable User ID requirement

Supervisor Access A Supervisor CODE CHIPTM module is shipped with each meter. Installing the CODE CHIPTM module gives the supervisor access to the Set Parameters and Delete Results function. To insert the Supervisor CODE CHIPTM module into the Alere Triage® MeterPro, slide the chip labeled “SPR” into the meter’s CODE CHIPTM module port as shown in the picture.

CODE CHIP

module

CODE CHIP

module Port

How to Set Parameters: Basic Instructions

Note: To save

All instructions assume:

changes, press the ENTER key. To cancel changes, press the EXIT key. When either the ENTER or EXIT keys are pressed, the meter performs the appropriate function and returns to the previous menu.

• The meter is on. • The meter screen is displaying the main menu. • The Supervisor CODE CHIPTM module is installed. 1. Select Set Parameters using the 2. Press the

keys.

key.

3. You will see a list of programmable parameters.

METER SETTINGS CLOCK USER ID RANGES TEST SETTINGS QC PARAMETERS BYPASS SELECT WITH v OR ^ AND PRESS ENTER OR PRESS EXIT The Set Parameters Menu

4. Use the

keys to select the parameter you want to program:

Meter Settings, Clock, User ID, Ranges, Test Settings, QC Parameters, or Bypass. 5. Press the

key.

6. Follow the directions for setting the selected parameter (see the next section). Main Menu

Meter Settings This menu will allow you to set basic operational criteria for the meter: language, display contrast, maximum length of the user, patient, auxiliary and misc. ID’s, printer mode and automatic power off.

Set Parameters Meter Settings ID Settings

ID Settings Characters User ID This setting will set the minimum and maximum number of characters in the User ID. 1. From a list of programmable parameters, choose Instrument Settings using the 2. Press the 3. Use the 4. Press the

keys. key. keys to select ID Settings. key.

Main Menu Set Parameters Meter Settings ID Settings

keys to select the number to the right of Characters User ID

5. Use the

under the Min column. 6. Use the

keys to choose the smallest number of characters that will

appear in the User ID. The minimum number of characters possible is 1. 7. Use the

key to select the number to the right of Characters User ID under the

Max column. 8. Use the

keys to choose the largest number of characters that will appear

in the User ID. The maximum number of characters possible is 16. 9. Press the

key to save changes.

Characters Pat. ID This setting will set the minimum and maximum number of characters in the Patient ID. 1. From a list of programmable parameters, choose Instrument Settings using the 2. Press the 3. Use the 4. Press the 5. Use the

keys. key. keys to select ID Settings. key. keys to select the number to the right of Characters Pat. ID

under the Min column. 6. Use the

keys to choose the smallest number of characters that will

appear in the Patient ID. The minimum number of characters possible is 1. 7. Use the

key to select the number to the right of Characters Pat. ID under the

Max column. 8. Use the

keys to choose the largest number of characters that will appear

in the Patient ID. The maximum number of characters possible is 20. 9. Press the

key to save changes.

Characters Aux. ID

Main Menu

This setting will set the minimum and maximum number of characters in the Auxiliary ID.

Set Parameters

If the setting of Aux. ID Enable/Disable is Enabled, an Auxiliary ID is mandatory for each

Meter Settings

patient test.

ID Settings

1. From a list of programmable parameters, choose Meter Settings using the 2. Press the 3. Use the 4. Press the 5. Use the

keys. key. keys to select ID Settings. key. keys to select the number to the right of Characters Aux. ID

under the Min column. Note: The Auxiliary 6. Use the

keys to choose the smallest number of characters that will

appear in the Auxiliary ID. The minimum number of characters possible is 1. 7. Use the

key to select the number to the right of Characters Aux. ID under the

Max column. 8. Use the

keys to choose the largest number of characters that will appear

in the Auxiliary ID. The maximum number of characters possible is 12. 9. Press the key to save changes.

Aux. ID Enable/Disable This setting will turn on or turn off the Auxiliary ID function. The Auxiliary ID may be used for recording a test order number, physician ID or other specialized identifying information. 1. From a list of programmable parameters, choose Meter Settings using the 2. Press the 3. Use the 4. Press the

keys. key. keys to select ID Settings. key.

5. Use the

keys to select the word to the right of Aux. ID Enable/Disable.

6. Use the

keys to choose Disabled or Enabled. If Disabled is selected,

the Auxiliary ID prompt screens will never appear. If Enabled is selected, an Auxiliary ID is mandatory for each patient test. 7. Press the

key to save changes.

ID is shown only on the New Result display or printout. It is not visible in recalled results. Tracking may be managed through the optional software package, Alere Triage® Census Data Management.

Main Menu Set Parameters Meter Settings ID Settings

Characters Misc. ID This setting will set the minimum and maximum number of characters in the Misc. Test ID. 1. From a list of programmable parameters, choose Instrument Settings using the 2. Press the

keys. key. keys to select ID Settings.

3. Use the 4. Press the

key. keys to select the word to the right of Characters Misc. ID under

5. Use the the Min column. 6. Use the

keys to choose the smallest number of characters that will

appear in the Misc. Test ID. The minimum number of characters possible is 1. 7. Use the

key to select the number to the right of Characters Misc. ID under

the Max column. 8. Use the

keys to choose the largest number of characters that will appear

in the Misc. Test ID. The maximum number of characters possible is 20. 9. Press the

Main Menu Set Parameters Meter Settings Display Settings

key to save changes.

Display Settings Language This setting will determine which language the meter displays and prints. 1. From a list of programmable parameters, choose Meter Settings using the 2. Press the 3. Use the 4. Press the 5. Use the

keys. key. keys to select Display Settings. key. keys to highlight the name to the right of Language.

6. Use the keys to change the language of the Alere Triage® MeterPro’s screen and printouts. 7. Press the

key to save changes.

Print Mode

Main Menu

This setting will determine if the meter prints automatically or only when requested. 1. From a list of programmable parameters, choose Meter Settings using the 2. Press the

keys.

4. Press the

keys to select Display Settings. key.

5. Use the

keys to select highlight the word to the right of Print Mode.

6. Use the

keys to choose Automatic or Manual. If Automatic is selected,

the meter will immediately print out the results after each test (patient, QC, Misc. Test). If Manual is selected, the user must use the

button on the keypad to

print out results. 7. Press the

Meter Settings Display Settings

key.

3. Use the

Set Parameters

key to save changes.

Main Menu Set Parameters Meter Settings Display Settings

Auto Power – Off This setting will determine the length of time before an inactive meter will power off. 1. From a list of programmable parameters, choose Meter Settings using the 2. Press the 3. Use the 4. Press the

keys. key. keys to select Display Settings. key.

5. Use the

keys to select the value to the right of Auto Power-Off.

6. Use the

keys to choose the desired timer setting for the meter to power

itself off when not in use. The choices are: 1/2 hour, 1 hour, 2 hours, 4 hours or NONE. If NONE is selected, the meter must be manually shut off using the on/off key. Note: When powered only by batteries, select 1/2 hour to conserve battery life. Certain screens, when displayed, will not automatically power off. The New Results screen is an example.

7. Press the

key to save changes.

Display Contrast This setting will adjust the display contrast. 1. From a list of programmable parameters, choose Meter Settings using the 2. Press the 3. Use the 4. Press the

keys. key. keys to select Display Settings. key.

5. Use the

keys to select the number to the right of Contrast.

6. Use the

keys to change the contrast of the meter’s screen.

The range is from 0 – 8 (8 being the greatest contrast). 7. Press the

key to save changes.

(Intentionally blank)

Main Menu Set Parameters Meter Settings Display Settings

Printer Contrast This setting will adjust the printer contrast for meters with serial numbers 29901 or greater. 1. From a list of programmable parameters, choose Meter Settings using the 2. Press the

keys. key. keys to select Printer Contrast.

3. Use the 4. Press the

key.

5. Use the

keys to select the number to the right of Contrast.

6. Use the

keys to change the contrast of the meter’s screen.

The range is from 0 – 8 (8 being the greatest contrast). 7. Press the

key to save changes.

Communication Settings Main Menu

Prior to activating the LIS feature, obtain the meter’s serial number located underneath

Set Parameters

the meter and contact Alere (Refer to the Contact Alere section).

Meter Settings

The Alere™ Representative will provide you with a password that, when entered, will allow

Comm Settings

data to be transmitted.

Baud Rate 1. From a list of programmable parameters, choose Meter Settings using the 2. Press the 3. Use the 4. Press the

keys. key. keys to select Comm Settings. key.

5. Use the

keys to select Baud Rate.

6. Use the

keys to choose 9600 or 38400.

7. Press the

key.

Patient Result Approval

Main Menu

Some institutions may desire patient test results to be verified by the user before printing

Set Parameters

or sending to the LIS. Activation of this feature displays the result, then requires the user

Meter Settings

to accept or reject the result before the record is printed and saved. If the test is rejected,

Comm Settings

the meter will permanently flag it as rejected by the user.

1. From a list of programmable parameters, choose Meter Settings using the 2. Press the 3. Use the 4. Press the

keys. key. keys to select Comm Settings. key.

5. Use the

keys to select Pat. Result Approval.

6. Use the

keys to choose Disabled or Enabled.

7. Press the

key.

When enabled, after a patient result is available and displayed on the meter screen, the user must accept or reject the result before printing, uploading or performing any other meter functions. The meter prompts the user to Press 1 to Accept or 0 to Reject. Once the test has been accepted or rejected, the meter operates normally. If the test has been rejected, the display and printout will be flagged with Pat. Result Rejected or Results Rejected by User. Recalled results will display an R before the patient ID in the rejected record.

Main Menu Set Parameters Meter Settings Comm Settings

LIS Enable 1. From a list of programmable parameters, choose Meter Settings using the

keys.

2. Press the

key. keys to select Comm Settings

3. Use the 4. Press the

key.

5. Use the

keys to select LIS.

6. Use the

keys to choose Disabled or Enabled.

7. Press the

key.

8. If Disabled was selected, a screen showing LIS Disabled will appear. Press the

key.

9. If Enabled was selected, a screen showing Enter LIS Password will appear. Enter the password provided by the Alere™ Representative. Press the 10. Acknowledge the LIS Enabled message by pressing the

key.

Auto Upload (This feature is visible after the LIS has been enabled.) 1. From a list of programmable parameters, choose Meter Settings using the 2. Press the 3. Use the 4. Press the

keys. key. keys to select Comm Settings. key.

5. Use the

keys to select Auto Upload.

6. Use the

keys to choose Enabled or Disabled.

7. Press the

key.

Clock

Main Menu

The clock menu sets the time and date of the meter and the format for displaying both. If

Set Parameters

the meter has lost power, the time and date will blink on the Main Menu.

Clock

1. From the list of programmable parameters, choose Clock using the 2. Press the

keys.

key.

Note: If you have selected

3. Use the

keys to select the Hour : Minute area. Using the keypad, type in

the correct time. The numbers you type will appear from the right and move left as you continue to type. 4. Press the

key to move to AM or PM. If the 24 HR., format has been previously

selected, the AM or PM will not be visable and the Time Format will be highlighted. Procede to step 7 below. 5. Select AM or PM using the 6. Press the 7. Use the

keys.

key to move to Time Format. keys to select AM/PM or 24 HR. If selecting 24 HR.,

the previously entered Hour : Minute will change to a 24-hour format and the AM or PM will disappear. 8. Press the

key to move to the Date.

9. Using the keypad, type in the 6-digit date according to the Date Format below it. 10. Press the 11. Use the

key to move to the Date Format. keys to select MM-DD-YY, DD-MM-YY or YY-MM-DD.

The previously entered Date changes as the Date Format changes. 12. Press the

key to save changes.

AM/PM, AM or PM appears after the time, as appropriate.

Main Menu

User ID

Set Parameters

Up to 600 User ID’s with 1 – 16 characters digits may be programmed into the meter.

User ID

The User ID may alternately be entered using the external Bar Code Scanner (optional). An additional security feature of the User ID is the partial masking of the ID on displays and printouts. This prevents unauthorized individuals from detecting and using an existing User ID. When the Supervisor CODE CHIPTM module is installed in the meter, this feature is overridden and all User ID characters are displayed.

Note: User ID 9999999999 (10-9’s) is a default setting displayed when the User ID Bypass is on or when a test is run with the Supervisor CODE CHIP™ module installed.

New User ID 1. From the list of programmable parameters, choose User ID using the 2. Press the

keys. key.

3. Select New User ID using the 4. Press the

keys.

key.

5. Type in a User ID with a number of characters within Min Characters User ID and Note: If you type in a User ID that has already been assigned, the message on the screen states: USER ### ALREADY EXISTS. Press the ENTER key to go back and type in a different ID.

Max Characters User ID. To correct, press the

key to clear the entire ID, or

select the incorrect character by using the

keys. Then type in the

correct ID. 6. Press the

key.

7. On the next screen, use the

keys to select an expiration date to the

right of User ID Status: 6 months, 12 months, valid or expired. 8. Press the

key to save changes.

The Alere Triage® MeterPro recognizes leading 0’s as a unique character. Therefore, ‘4341’ will be recognized separately from ‘04341’. Using the barcode scanner or alpha mode (shift key) will allow the Alere Triage® MeterPro to accept alpha characters and the following symbols: # ( ) * - . /

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Alere

Fluorescence Systems

Triage MeterPro User Manual rev A