Piccolo Xpress Operators Manual Rev E Oct 2020

The Information in the manual is relevant for analyzer part numbers 1100-1001 and 1100-1001R. Analyzers 1100-1001 and 1100-1001R report to catalog numbers 1100-0000, 1100-0000E, 1100-0000R and 1100-0000ER.

Table of Contents Section 1: General Information... 1.1 Intended Use... 1.2 Universal Precautions... 1.3 Introduction... 1.4 Technical Support... 1.5 Symbols Used in Labeling...

1-1 1-2 1-2 1-3 1-4 1-4

Section 2: Setup and Description... 2-1 2.1 Unpacking... 2-2 2.2 Physical & Environmental Specifications... 2-3 2.3 Setup... 2-3 2.4 Piccolo Xpress System Description... 2-5 2.5 Touchscreen and Front Panel... 2-6 2.6 Reagent Discs... 2-7 2.7 Installing a Printer Paper Roll... 2-9 2.8 Ancillary Products... 2-10 2.9 Optional Accessories... 2-10 Section 3: Testing and Results... 3-1 3.1 Sample Requirements... 3-2 3.2 Preparing the Reagent Disc... 3-4 3.3 Running a Patient Sample... 3-6 3.4 Canceling Analysis... 3-11 3.5 Results... 3-11 3.6 Testing Procedure Summary... 3-16 Section 4: Configuring the Analyzer... 4-1 4.1 Using the Settings Screen... 4-2 4.2 Customizing Reference Ranges... 4-2 4.3 Printing and Archiving Reference Ranges... 4-11 4.4 Retrieving Reference Ranges... 4-12 4.5 Transmitting Reference Ranges... 4-13 4.6 Viewing Analyzer Information... 4-15 4.7 Changing Date and Time... 4-15 4.8 Selecting the Language... 4-16 4.9 Selecting Units... 4-17 4.10 Setting Sound Volumes... 4-21 4.11 Adjusting the Display... 4-22 4.12 Printer Settings... 4-24 4.13 Setting Communication Protocol... 4-28 4.14 Using Optional Data Functions... 4-29 4.15 Running Controls... 4-31 4.16 Security Settings... 4-34

Table of Contents

TOC-1

Section 5: Recalling Results... 5.1 Troubleshooting Flags... 5.2 Recalling Results from the Last Disc Run... 5.3 Searching for Results... 5.4 Browsing Results... 5.5 Transmitting All Results...

5-1 5-2 5-2 5-3 5-8 5-9

Section 6: Calibration and Quality Control... 6.1 Calibration... 6.2 Quality Control Features... 6.3 Running External Controls...

6-1 6-1 6-1 6-2

Section 7: Troubleshooting... 7.1 Error Messages... 7.2 Electrostatic Discharge... 7.3 Technical Support... 7.4 Disc Cancellations... 7.5 Instrument and Result Messages... 7.6 Reinitializing the Analyzer...

7-1 7-1 7-1 7-1 7-2 7-2 7-4

Section 8: Operating Principles... 8-1 8.1 Principles of Procedure... 8-1 8.2 Principles of Operation... 8-2 Section 9: Maintenance and Service... 9.1 Cleaning the Analyzer... 9.2 Cleaning Spills... 9.3 Cleaning the Air Filter... 9.4 Updating the Analyzer Software... 9.5 Returning the Analyzer to Abaxis for Service...

9-1 9-1 9-2 9-2 9-3 9-4

Section 10: Connecting a Computer/Printer... 10-1 10.1 Connecting an External Printer... 10-2 10.2 Connecting a Computer... 10-2 10.3 Transmission Specifications... 10-2 10.4 Installing the Abaxis Driver... 10-3 10.5 Capturing Results with HyperTerminal... 10-9 Index...

Table of Contents

I-1

TOC-2

Section 1

General Information This section provides an overview of the Piccolo Xpress chemistry analyzer.

1.1 Intended Use... 1-2 1.2 Universal Precautions... 1-2 1.3 Introduction... 1-3 1.4 Technical Support... 1-4 1.5 Symbols Used in Labeling... 1-4

General Information

1-1

1.1

Intended Use

The Piccolo Xpress chemistry analyzer provides quantitative in-vitro determinations of clinical chemistry analytes in lithium-heparinized whole blood, heparinized plasma, or serum. CAUTION:

Note:

1.2

If the Piccolo Xpress chemistry analyzer is used in any way other than described in this manual, the analyzer may not operate as intended, may produce inaccurate or no results, and may pose a safety hazard.

Use only Piccolo reagent discs with the Piccolo Xpress chemistry analyzer.

Universal Precautions

Operator health and safety regulations require that Universal Precautions be observed at all times while handling human blood samples or working with the Piccolo Xpress chemistry analyzer in any way. For details, see OSHA 29 CFR Part 1910 (“Occupational Safety and Health Standards”), Standard Number 1910.1030 (“Toxic and Hazardous Substances: Bloodborne Pathogens”), which can be found by visiting http://www.osha.gov and searching for “1910.1030”. For further guidelines on handling and disposing of hazardous laboratory wastes, refer to Clinical Laboratory Waste Management; Approved Guideline - Second Edition (GP5-A2), from the Clinical and Laboratory Standards Institute (formerly NCCLS). This can be found at http://www.clsi.org.

General Information

1-2

1.3

Introduction

The Piccolo Xpress chemistry system is compact and easy to transport. The system consists of a portable analyzer and single-use disposable reagent discs. The analyzer contains the following features and components: ◼

a variable-speed motor to spin the reagent disc

◼

a photometer to measure analyte concentrations

◼

two microprocessors to control testing and analytical functions

◼

a thermal line printer to print out results

◼

a WVGA color touchscreen for communicating with the analyzer

◼

optional data functions for more detailed analysis information

Each reagent disc is self-contained clear plastic, 8 cm in diameter and 2 cm thick, and containing an aqueous diluent in its center and dry reagent beads in cuvettes around its edge. All blood separation and sample diluent mixing is performed within the disc itself. To perform an analysis, the operator needs only to collect a blood sample (lithium-heparinized whole blood or plasma, serum), place the sample in the reagent disc, put the disc into the analyzer drawer on the front of the analyzer, and input patient information. When analysis is finished, the results print automatically. Results are printed on thermal paper with adhesive backing for inclusion within the patient's medical record. One Ethernet port and five USB ports are provided so data can be sent to an external printer, computer, memory stick, or laboratory information systems/electronic medical record systems (LIS/ EMR). The entire analysis requires ~100 µL of sample and is capable of providing results in about 12 minutes. Note:

This manual includes a number of analyzer screens and computer screen captures. The analyzer screens are illustrations only, not exact duplications. All screens represent typical use and installations, and may differ in some minor details from the screens on your system.

General Information

1-3

1.4

Technical Support

Abaxis Technical Support personnel are trained to answer questions regarding the operation of the Piccolo Xpress chemistry analyzer. For technical support, call or contact:

1.5

◼

USA: 1-800-822-2947 USA: [email protected]

◼

Europe: [email protected]

Symbols Used in Labeling

The following symbols are found on the back of the analyzer, on the Piccolo Xpress label and above the connectors.

Symbol

Explanation

Direct current

!

Caution Refer to any accompanying documents.

Biohazard In accordance with good laboratory practice, all material from human sources should be considered potentially infectious, and handled with the same precautions used with patient specimens. See “Universal Precautions” on page 1-2.

USB connection

Network connection

General Information

1-4

Section 2

Setup and Description This section describes how to unpack the Piccolo Xpress analyzer, and how to set it up in a suitable environment. This section also introduces the analyzer’s front panel and touchscreen user interface.

2.1 Unpacking... 2-2 2.2 Physical & Environmental Specifications... 2-3 2.3 Setup... 2-3 2.4 Piccolo Xpress System Description... 2-5 2.5 Touchscreen and Front Panel... 2-6 2.6 Reagent Discs... 2-7 2.7 Installing a Printer Paper Roll... 2-9 2.8 Ancillary Products... 2-10 2.9 Optional Accessories... 2-10

Setup and Description

2-1

2.1

Unpacking

1.

Remove the Piccolo Xpress chemistry analyzer from its shipping carton.

2.

Place the analyzer on a level surface that is free of hair, dust, and other contaminants. Do not place the analyzer near a sunny window or any other heat source.

3.

Check the components received with the Piccolo Xpress against the following figure to make sure everything required to set up the analyzer is included. Printer and cover

Touchscreen

Disc drawer Power cord and power adapter Power button

Note:

4.

The shipping carton also includes these items, not shown above: a USB cable, Abaxis Driver CD, Piccolo Xpress Operator's Manual (this manual), warranty card, and Startup kit. After setup, complete the warranty card and mail it to Abaxis within 10 days to start the warranty period. Customers are placed on the customer mailing list to receive any information pertaining to the Piccolo Xpress and ancillary products, such as software upgrades.

Setup and Description

2-2

2.2

Physical & Environmental Specifications Dimensions

Weight Mode of operation Protection against fluid ingress Altitude Ambient operating temperature Humidity Reaction temperature Thermal protection rating Power requirements

Main supply voltage Transient overvoltages Pollution

2.3 1.

Height: Width: Depth:

32.5 cm (12.80 inches) 14.9 cm (5.87 inches) 21.0 cm (8.27 inches)

Analyzer: Power adapter:

5.3 kg (11.6 pounds) 1.0 kg (2.3 pounds)

Continuous Ordinary equipment (IPXO) 2000 m (6562 ft) 15–32 ºC (59–90 ºF), indoor use 8–80% relative humidity noncondensing 37 ºC (98.6 ºF) 70 ºC (158 ºF) 100–240 volts AC, 50–60 Hz or 16 volts DC, 5.0 A Main unit: 1.1–0.45 amps, 16 volts DC, 5.0 A Fluctuations not to exceed ± 10% of the nominal voltage Installation Category II in accordance with UL 61010A-1 second edition Annex J Degree 2 in accordance with IEC 664

Setup Set up the Piccolo Xpress on a surface that is as follows: ❑ Level ❑ Free of vibration and sudden jolts ❑ Free of hair, dust, and other contaminants ❑ Located in an ambient operating temperature of 15–32 ºC (59–90 ºF) ❑ Away from sunny windows and all other potential heat sources ❑ At least six inches from any wall to provide adequate ventilation and access to the

power connection and USB ports

Setup and Description

2-3

2.

Plug the power jack into the analyzer, then plug the detachable power supply cord into the power adapter and into a grounded electrical outlet.

CAUTION:

3.

To prevent power surges or drain, do not plug the analyzer into the same circuit as a centrifuge or any other high-current device. Abaxis also recommends using a suitable surge protector.

Press the Power button to turn on the analyzer. The display then shows the following:

Note:

4.

If the display is blank (shows no message), remove the plug from the power adapter, then re-insert the plug and press firmly to make sure it seats correctly. After passing the self test and reaching operating temperature, the analyzer is ready to run the first reagent disc, and displays Analyze. See “Quality Control Features” on page 6-1 for details about the analyzer self test. The analyzer may require additional time to reach operating temperature.

5.

Check the analyzer date and time to ensure they are correct. See “Changing Date and Time” on page 4-15 for directions.

6.

The analyzer can be connected to an external computer or printer to transmit or print patient and control results. See “Connecting a Computer/Printer” on page 10-1 for instructions.

Setup and Description

2-4

7.

2.4

Reference ranges are preset when the analyzer is shipped from the factory. The range values can be changed using the Customizing Reference Range feature described in “Customizing Reference Ranges” on page 4-2.

Piccolo Xpress System Description

The Piccolo Xpress chemistry system consists of a portable analyzer and disposable single-use reagent discs. Each reagent disc contains all the reagents needed to perform a panel of tests on a single sample. Be sure to become familiar with the system before running samples. The Piccolo Xpress analyzer uses centrifugal and capillary forces to process heparinized whole blood samples and distribute diluted plasma to the reaction chambers (cuvettes) in the reagent disc. Serum and heparinized plasma samples are processed in a similar manner. The analyzer optically measures the chemical reactions and calculates analyte concentrations from these measurements and from encoded calibration data contained on the bar code ring on the reagent disc. Results are stored in memory, and can be printed using the built-in thermal printer or downloaded to an external personal computer for data management. The touchscreen display provides easy communication with the analyzer. The touchscreen shows procedural instructions, indicates the status of the analyzer, and presents any error messages. For details, see “Touchscreen and Front Panel” on page 2-6. The reagent disc drawer slides out from the front of the analyzer, and transports the reagent disc (see “Reagent Discs” on page 2-7) into the analyzer and automatically positions it for analysis. The analyzer prints results on adhesive-backed thermal paper tape, through its internal printer. An external power adapter and two power supply cords are provided: one connects the power adapter to the back of the analyzer, and the other connects the adapter to a surge protector designed for use with a computer. The analyzer also has several USB connectors: use the top USB connector for connecting to an external computer (see “Connecting a Computer/Printer” on page 10-1 for details). The analyzer is easy to carry using the recessed handle incorporated into the top of the unit.

Setup and Description

2-5

2.5

Touchscreen and Front Panel

You'll use the analyzer's touchscreen display to operate the analyzer. ◼

Use the on-screen keyboard and numerical keypad to input patient information.

◼

To enter accented letters, select and hold the letter key in the on-screen keyboard, then select the accented version from the choices that appear.

◼

The left and right arrow touchscreen keys move the display cursor forward or backward to change a number on the display. The right arrow key (  ) functions as a dash (–) when entering a patient identification number. The left arrow key (  ) functions as a backspace.

◼

Use the up (  ) and down (  ) arrow keys to scroll through a displayed list of items, or to increase or decrease a displayed value.

◼

Operating functions are available through various icons on the touchscreen, as well as specific keys that appear on the touchscreen according to the actions performed.

◼

Select Back on the touchscreen to cancel a choice and return to the previous screen, or to move backward through a series of screens.

Turn the analyzer's power on and off by pressing the Power button on the front of the instrument. Note:

The Power button works only when the disc drawer is closed and contains no reagent disc.

Power button

To open or close the disc drawer, select Analyze or Close on the touchscreen. Closing a drawer containing a reagent disc initiates an analysis.

Results for previously analyzed samples can be accessed using the Recall function. See “Recalling Results” on page 5-1 for instructions. Setup and Description

2-6

2.5.1

Information Icons

A number of the analyzer’s touchscreen displays include an information icon get additional information about the procedure you're performing. For example, in the screen that appears when you load a disc, pressing outlining the basic analysis procedure:

that you can select to

displays these screens

Select Next and Back to move through the information screens, and Exit to close them.

2.6

Reagent Discs

2.6.1

Disc Structure and Function

All chemistry reactions in the Piccolo Xpress system are performed inside clear plastic reagent discs, 8 cm in diameter and 2 cm thick, specially designed to convert a few drops of whole blood, plasma, or serum into a panel of test results. Each disc contains all components and reagents needed to perform one or more tests on a single sample. A total of 30 cuvettes are located around the periphery: ◼

◼

◼

bar code ring

four system cuvettes contain QC reagent beads for instrument and chemistry quality control

cuvettes sample port

minimum and maximum absorbance cuvettes are used for calibration a specially designed cuvette detects whether sample volume was sufficient

diluent container sample fill line

◼

a cuvette verifies that sufficient diluted sample was delivered to the reaction cuvettes

◼

an empty cuvette captures excess fluids

◼

21 cuvettes contain test-specific lyophilized reagent beads Setup and Description

2-7

The bar code ring attached to the top of the reagent disc contains calibration data for the specific chemistries in the disc. It also contains the disc identification code, lot number, and expiration date. The analyzer automatically checks the code and rejects any expired disc. The bar code ring also protects the optical surfaces of the cuvette from fingerprints and debris, and helps minimize contamination of the analyzer by capturing small drops of blood that may be on the disc surface. The sample port, marked by an arrow pointing to a molded circle on the disc's upper surface, provides access to the sample chamber. When sufficient sample has been loaded into the sample chamber, the sample fill line forms between two molded arrows on the disc surface. A sample diluent is sealed in a container inside the center of the disc. At the beginning of the reaction cycle, the analyzer opens this container and releases the diluent. The analyzer separates a lithium-heparinized whole blood sample by centrifugation inside the disc. Plasma and serum samples are unaffected. Precisely measured quantities of sample and diluent are delivered to the mixing chamber. Centrifugal and capillary forces then deliver the diluted sample to the cuvettes, where it dissolves the reagent beads and initiates the chemical reactions. Reaction products in the cuvettes are then measured photometrically.

2.6.2

Disc Storage and Handling

CAUTION:

Discs are fragile - always handle with care. Do not tap discs on the table or work bench to empty the sample port. Do not use a disk that has been dropped. Inspect every reagent disc for damage before use. Never use a damaged disc.

Note:

◼

Store each reagent disc as described on its label. This keeps the disc's reagents stable until the expiration date printed on the disc's foil pouch and encoded in its bar code ring. The analyzer automatically rejects any expired disc.

◼

Discs can be used directly from the refrigerator (stored at 2–8 °C) without warming.

◼

A disc can remain in its sealed pouch at room temperature for a cumulative period of 48 hours. Longer time at room temperature can cause suppression of chemistries and disc cancellations.

◼

Do not expose discs in or out of their foil pouches to direct sunlight or to temperatures above 32 °C (90 °F).

◼

Inspect the unopened foil pouch for tears and punctures. A torn or damaged pouch can allow moisture to reach the disc and reduce reagent performance.

◼

Open the disc pouch at the notch on the top right edge of the package. You must use the disc within 20 minutes of opening its pouch.

Setup and Description

2-8

◼

Once the pouch is opened, do not place the disc back in the refrigerator for later use.

◼

Keep discs clean. Handle them only by their edges to avoid smudges on the optical surfaces. Use a lint-free tissue to remove any spilled blood from disc surfaces.

◼

Optional: Write the patient identification number on the disc surface in the space shown at right. Do not write anywhere else on the disc, or on the bar code ring.

◼

Hold reagent discs flat after introducing the sample or control to avoid spillage.

Write patient ID here

WARNING: BIOHAZARD: USED REAGENT DISCS CONTAIN BODY FLUIDS. FOLLOW GOOD LABORATORY WORKING PRACTICES. HANDLE ALL USED DISCS AS IF THEY ARE CONTAMINATED WITH HEPATITIS OR OTHER INFECTIOUS DISEASES. CHECK WITH THE APPROPRIATE STATE AGENCY REGARDING DISPOSAL REGULATIONS. FOR MORE INFORMATION, SEE “UNIVERSAL PRECAUTIONS” ON PAGE 1-2.

2.7

Installing a Printer Paper Roll

1.

Open the printer cover. If the printer contains a roll of paper, remove it.

2.

Remove the wrapper from the new paper roll, then unroll several inches of printer paper.

3.

Put the paper roll into the printer so that the paper unrolls from the bottom of the roll and out towards the front of the analyzer, as shown.

4.

Make sure several inches of paper extend out of the printer slot.

5.

Press the cover closed until it locks into place.

6.

Pull gently on the end of the paper until it is taut.

Setup and Description

2-9

2.8

Ancillary Products

To order consumables or supplies such as reagent discs, pipettes, tips, printer paper, or control samples, contact your authorized distributor, or contact Abaxis Customer Service. Operational Materials

2.9

Catalog Number

Pipette tips, disposable, pack of 96

Abaxis #500-9007

Mini pipette, 100 ml, gray

Abaxis #500-9006

Internal printer paper rolls, box of 6

Abaxis #1100-4410

Fan filter, covered

Abaxis #1987-0009

Optional Accessories

These items can be attached to the analyzer using its USB ports: ◼

USB keyboard

◼

External printers: contact Abaxis Technical Support for specific models

◼

Barcode scanners: contact Abaxis Technical Support for specific models

Setup and Description

2-10

Section 3

Testing and Results This section provides general introductory information about the Piccolo Xpress analyzer, reagent discs, test procedures, and test results.

3.1 Sample Requirements... 3-2 3.2 Preparing the Reagent Disc... 3-4 3.3 Running a Patient Sample... 3-6 3.4 Canceling Analysis... 3-11 3.5 Results... 3-11 3.6 Testing Procedure Summary... 3-16

Testing and Results

3-1

3.1

Sample Requirements ◼

The Piccolo Xpress chemistry analyzer accepts lithium-heparinized whole blood, plasma, or serum samples.

◼

Lithium heparin is the only anticoagulant recommended for use with the Piccolo Xpress.

Note:

When collecting the sample in lithium heparin collection tubes, fill the tube at least halfway so the anticoagulant does not become too concentrated in the sample. ◼

If using CLIA '88 Waived reagent discs: only lithium-heparinized whole blood can be used as a sample.

◼

If performing a Basic Metabolic Panel Plus: only lithium-heparinized plasma or serum can be used as a sample. Heparinized whole blood cannot be used.

◼

A sample size of 90–120 µL is required.

◼

Whole blood must be analyzed within 60 minutes of collection, or separated into plasma or serum.

◼

To prevent hemolysis, do not refrigerate or shake whole blood.

◼

Plasma or serum can be stored at room temperature for no longer than 5 hours after centrifugation. If storage for more than 5 hours is required, refrigerate the sample in the stoppered tube at 2-8 °C (36-46 °F) for no longer than 48 hours, or store it at -10 °C for up to 5 weeks in a freezer with no self-defrost cycle. Under these conditions, there will be no clinically important changes in most analyte concentrations.

◼

For accurate interpretation of glucose and lipid results, the patient should fast for at least 12 hours before the sample is collected.

WARNING: OPERATOR HEALTH AND SAFETY REGULATIONS REQUIRE THAT UNIVERSAL PRECAUTIONS BE OBSERVED AT ALL TIMES WHILE HANDLING HUMAN BLOOD SAMPLES OR WORKING WITH THE PICCOLO XPRESS CHEMISTRY ANALYZER IN ANY WAY.

FOR DETAILS, PLEASE REFER TO OSHA 29 CFR PART 1910 (“OCCUPATIONAL SAFETY AND HEALTH STANDARDS”), STANDARD NUMBER 1910.1030 (“TOXIC AND HAZARDOUS SUBSTANCES: BLOODBORNE PATHOGENS”), WHICH CAN BE FOUND BY GOING TO HTTP://WWW.OSHA.GOV AND SEARCHING FOR “1910.1030”. WARNING: OPERATORS MUST ALSO BE AWARE OF STATE AND LOCAL OSHA BIOHAZARD REGULATIONS THAT MAY SPECIFY REQUIREMENTS IN ADDITION TO THE FEDERAL REGULATIONS, AND MUST ALSO ENSURE COMPLIANCE PROCEDURES ARE IN PLACE.

Testing and Results

3-2