Abbott 100-7008 Rev M Piccolo Operators Manual2 Pompe volumetirc Alaris VP Plus Guarrils Modele: 9003TIG03-G Mode d'emploi

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Piccolo® Point-of-Care Chemistry Analyzer

Operator’s Manual

For in vitro diagnostic use

Abaxis, Inc.

3240 Whipple Road

Union City, California, USA

94587

800-822-2947

Customer Service and Technical Support

PN 100-7075 Rev. D Assembly

PN 100-7008 Rev. M Text

June 2004

Piccolo Operator’s Manual

Section 1: Piccolo Features and Components

1.1 Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

1.2 Universal precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

1.3 Near-patient testing efficiency . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

1.4 Overview of the procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

1.5 External features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2

1.5.1 Display and keypad . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-2

1.5.2 Disc drawer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-2

1.5.3 Result card slot . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3

1.5.4 Power supply. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3

1.5.5 Computer ports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3

1.5.6 Symbols used in labeling . . . . . . . . . . . . . . . . . . . . . . . . 1-3

1.5.7 Physical and environmental specifications. . . . . . . . . 1-4

1.6 Internal components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4

1.6.1 Optics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-4

1.6.2 Microprocessors and memory . . . . . . . . . . . . . . . . . . . 1-4

1.6.3 Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5

1.7 Piccolo reagent discs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5

1.7.1 Disc structure and function . . . . . . . . . . . . . . . . . . . . . . 1-5

1.7.2 Disc storage and handling. . . . . . . . . . . . . . . . . . . . . . .1-6

1.8 Result cards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7

1.9 Intelligent QC (iQC™) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7

1.9.1 Instrument iQC™ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8

1.9.2 Reagent iQC™. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8

1.9.3 Performance iQC™. . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-8

1.10 Setup and power supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9

1.10.1 Shipping verification . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9

1.10.2 Powering up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-9

1.10.3 Powering down. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10

1.11 Connecting to an external computer . . . . . . . . . . . . . . . . . . . . . 1-11

1.12 Bar Code Scanner Option/Requirements. . . . . . . . . . . . . . . . . 1-11

1.12.1 Communication Interface. . . . . . . . . . . . . . . . . . . . . . .1-11

1.12.2 Communication Parameters . . . . . . . . . . . . . . . . . . . .1-11

1.12.3 Barcode Formats . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-11

1.13 Consumables and ancillaries . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11

1.14 Customer service and technical support. . . . . . . . . . . . . . . . . . 1-11

Section 2: Testing Procedure and

Interpretation of Results

2.1 Sample requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1

2.2 Testing procedure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1

2.2.1 Preparing the reagent disc . . . . . . . . . . . . . . . . . . . . . . .2-2

2.2.2 Running a patient sample . . . . . . . . . . . . . . . . . . . . . . .2-3

2.2.3 Canceling an analysis in progress. . . . . . . . . . . . . . . . .2-5

2.3 Interpreting patient results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6

2.3.1 Reading the result card. . . . . . . . . . . . . . . . . . . . . . . . . .2-6

2.3.2 Abnormal results: interpretation and further action .2-7

2.4 Running controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8

2.5 Limitations of the procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11

Section 3: The Menu Functions

3.1 Accessing a particular special function. . . . . . . . . . . . . . . . . . . 3-2

3.2 Viewing analyzer identification . . . . . . . . . . . . . . . . . . . . . . . . . 3-3

3.3 Changing the date and time . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4

3.4 Selecting the date format. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6

3.5 Selecting the time format. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7

3.6 Customizing reference ranges . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8

3.7 Printing reference ranges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10

3.8 Transmitting reference ranges . . . . . . . . . . . . . . . . . . . . . . . . . . 3-12

3.9 Selecting a language. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13

3.10 Selecting units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-14

3.11 Selecting the data format. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-15

Section 4: The Recall Function

4.1 Viewing or printing patient records . . . . . . . . . . . . . . . . . . . . . 4-1

4.2 Viewing or printing control records . . . . . . . . . . . . . . . . . . . . . 4-4

4.3 Viewing or printing error records . . . . . . . . . . . . . . . . . . . . . . . 4-7

4.4 Transmitting patient records . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8

4.5 Transmitting control records . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11

4.6 Transmitting error records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-14

Section 5: Maintenance and Troubleshooting

5.1 Routine maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1

5.1.1 Cleaning the exterior . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1

5.1.2 Cleaning the printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1

5.1.3 Cleaning the air filter . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2

5.2 Clearing a paper jam . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3

5.3 Installing a software card . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4

5.4 Reinitializing the analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5

5.5 Returning the analyzer to Abaxis for service . . . . . . . . . . . . . . 5-5

5.6 Error messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6

Piccolo Operator’s Manual

Section 1: Piccolo Features and Components

1.1 Intended use

The Piccolo® Point-of-Care Chemistry Analyzer provides quantitative in vitro determinations of clinical chemistry analytes in heparinized whole blood, heparinized plasma, or serum.

1.2 Universal precautions

Operator health and safety require that universal precautions be observed at all times while handling human blood samples or working with the Piccolo

Point-of-Care Chemistry Analyzer in any way. The complete text of the document “OSHA 29 CFR Part 1910, Occupational Exposure to Bloodborne Pathogens” can be found on the Internet at www.osha-slc.gov/Preamble/Blood_toc_by_sect.html.

1.3 Near-patient testing efficiency

This near-patient portable clinical chemistry system provides the clinician with routine multi-chemistry profiles and electrolytes for panels of blood tests within minutes. Less than 2 minutes of hands-on time is required to perform the test. The Piccolo

Point-of-Care Chemistry Analyzer eliminates the need to transport samples to a central laboratory, and reduces such problems as misplaced samples, inaccurate labeling and transcription, improper icing and bagging, and sample degradation. Important criteria for test efficiency include ease of use, along with minimal handling and processing steps. The Piccolo provides automation, easy operation, and reliable results to operators of almost any skill level.

1.4 Overview of the procedure

The Piccolo® system consists of the Piccolo® Pointof-Care Chemistry Analyzer, single-use disposable reagent discs, and result cards printed by the analyzer or transmitted to a data manager. External and internal features of the analyzer are described and illustrated below.

The operator begins the Piccolo ducing 100 µL of whole blood, plasma, or serum sample into a self-contained reagent disc and loading the disc into the analyzer. No sample preparation is required. The operator then enters patient, operator, and physician ID numbers using the keypad and display screen. The analyzer performs the remainder of the testing protocol automatically in less than 13 minutes. The used reagent disc is removed and the analyzer is ready for the next sample.

procedure by intro-

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4.5 3.7-5.8

5.4-8.2

12* 60-1

244 125-27

0.3-1.3

>180

l/L

8.6-11.8

♦♦♦ 200-1200

7-25

<10

0.1-0.6

3.3 2.5-4.4

10-1

20-150

000

000000827

04/05/96

T D R

6054

000

103195-2-1

PICCOLO

1:35

Piccolo Features and Components 1-1

Piccolo Operator’s Manual

The chemical reactions carried out by this analyzer are designed to produce a reaction that absorbs light at known wavelengths. Analyte concentration is calculated from light absorbance data. Results can be printed on result cards for purposes of assessment and for inclusion in the patient’s medical chart. Results are stored in the analyzer memory, and can be transmitted to an external computer.

1.5 External features

The Piccolo® Point-of-Care Chemistry Analyzer is a lightweight portable instrument that allows patient

Display

Keypad

testing at the point of care. Its small footprint allows convenient placement of the analyzer in a near-

Drawer

patient environment. The top surface has a 4-line display screen and keypad, and a recessed carrying handle. A sliding drawer and a slot for inserting result cards into the internal printer are on the front surface. The back surface includes connections for AC and DC power supply, as well as RS232 ports.

Result Card Slot

1.5.1 Display and keypad

The keypad and 4-line display screen facilitate interactive communication between the analyzer and the operator. The display indicates the status of the analyzer, and presents procedural instructions and error messages. It also reflects information input via the keyboard so it can be verified or corrected.

The operator inputs data through the 10 numeric keys, 6 function keys, and 2 arrow keys. Refer to the figure at the right for the keyboard layout. The specific uses of these keys are described in Sections 2, 3, and 4.

The

POWER key is used to power the analyzer up or

POWER

OPEN

78 9

down and to cancel a run in progress. Refer to 2.2.3. The

OPEN/CLOSE key operates the sliding drawer

where the reagent disc sits. This key is referred to in the text as either the containing a reagent disc initiates an analysis. Two of the function keys,

RECALL, provide access to special functions described in detail in Sections 3 and 4.

OPEN or CLOSE key as appropriate in context. Closing a drawer

MENU and

RECALL

EXIT

ENTER

1.5.2 Disc drawer

The disc drawer slides in and out to transport the reagent disc into the analyzer and hold it in place during the analysis. Keep the analyzer drawer closed when not loading or unloading a reagent disc. Always use the tion of the drawer. Do not push on the drawer to close it. This may damage the instrument.

1-2 Piccolo Features and Components

OPEN/CLOSE key to change the posi-

Piccolo Operator’s Manual

1.5.3 Result card slot

The result card slot, on the front surface of the analyzer below the disc drawer, provides access into the internal thermal printer. Refer to 1.6, 2.2.2, and Section 4 for information about printing result cards.

1.5.4 Power supply

The analyzer runs on AC or DC power, providing portability in point-of-care testing environments.

Recessed handle

AC Power supply cord

Two power supply components are included. The DC power supply plugs into the socket on the lower left back of the analyzer. An AC power cord connects the DC power adaptor to a grounded electrical outlet. A “universal” DC-to-AC power convertor is also available, as well as an accessory

RS232

computer

ports

Power supply

DC Power supply cord

that can plug into a vehicle’s lighter socket, allowing a 12-volt battery to be used as the power source.

1.5.5 Computer ports

Two RS232 ports support 2-way communication between the analyzer and external devices. Port 1 [labeled RS232(1)] is used for connecting the analyzer to a computer to transmit results. Port 2 is used for connecting an optional bar code scanner. Refer to

1.11 for information on linking the analyzer to an external computer.

1.5.6 Symbols used in labeling

The following symbols are found on the label on the bottom panel or above the connections on the back panel.

Symbol Explanation

Direct current

Caution (refer to accompanying documents)

Serial ports



Piccolo Features and Components 1-3

Piccolo Operator’s Manual

1.5.7 Physical and environmental specifications

Height: 24.2 cm 9.5 inches Width: 15.3 cm 6 inches Depth: 29.2 cm 11.5 inches Weight of the analyzer: 6.8 kg 15 pounds Weight of the power adapter: 0.6 kg 1.3 pounds Mode of operation: Continuous Protection against ingress of fluids: Ordinary equipment (IPXO) Ambient operating temperature: 15–32°C 59–90°F Humidity: 0–95%, non-condensing Reaction temperature: 37°C 98.6°F

Power requirements: 240–100 volts AC 50–60 Hz

or 12–15 volts DC

Thermal protection rating: 70°C 178°F

1.6 Internal components

Inside the analyzer is a variable speed motor to spin the disc, a spectrophotometer to measure analyte concentrations, two microprocessors to control testing and analytical functions, system software on a PCMCA card, and a thermal line printer for imprinting result cards. A heating system maintains the temperature of the disc at 37°C while reactions are in progress.

1.6.1 Optics

The measurement optics consist of a discrete wavelength spectrophotometer with a xenon lamp as a light source.

1.6.2 Microprocessors and memory

The architecture of the instrument consists of two microprocessors: a real-time controller that monitors and controls all the measurements; and an I/O (input/output) controller for memory management, calculations, and data storage. The two processors cross-check each other’s performance continuously, which allows a very high level of confidence in the working of the instrument, and consequently of the results and the integrity of the data.

The analyzer stores 70 patient results, 70 control results, and system quality control data. All data stored in memory can be accessed via the Recall function. Refer to Section 4.

1-4 Piccolo Features and Components

Piccolo Operator’s Manual

1.6.3 Software

The analyzer software comprises two matched programs. One program controls the measurement engine itself, i.e., it schedules the flashing of the light source and collects the light intensity data for different cuvettes at different times during the reaction; and it collects all the information generated in the analytical part of the instrument. The second program processes that information and reports analyte concentration. It also stores data related to each run (time, date, user ID, patient results, and control data).

Software upgrades are distributed to registered users on a PCMCA card and installed on site. Refer to 5.3 for instructions on installing a software card.

1.7 Piccolo reagent discs

1.7.1 Disc structure and function

In the Piccolo® system, all chemistry reactions are performed inside clear plastic reagent discs, 8 cm in diameter and 2 cm in depth, specially designed to perform all the steps required to convert a few drops of whole blood, plasma, or serum into a panel of test results. Each disc contains all the components and reagents needed to perform one or more tests on a single sample.

A total of 30 cuvettes are located around the periphery: 4 system cuvettes contain QC reagent beads for instrument and chemistry quality control (refer to 1.9); a minimum and a maximum absorbance cuvette are employed in calibrating the spectrophotometer; a specially designed cuvette detects whether sufficient sample volume was applied; one cuvette verifies that a sufficient aliquot of diluted sample was delivered to the reaction cuvettes; an empty cuvette captures excess fluids. The remaining 21 cuvettes contain test-specific lyophilized reagent beads.

The bar code ring attached to the top of the reagent disc contains calibration data specific for the chemistries in the disc. It also contains the disc identification code, lot number, and expiration date. The analyzer automatically checks the code and rejects an expired disc. The bar code ring also protects the optical surfaces of the cuvette from fingerprints and other debris, and helps minimize contamination of the analyzer by capturing small drops of blood that may be on the disc surface.

The sample port, demarcated by an arrow pointing to a circle molded onto the upper surface of the disc, provides access to the sample chamber. When sufficient sample has been loaded into the sample chamber, the sample fill line forms between two arrows molded on the disc surface.

Bar Code Ring

Cuvettes

Sample Port

Diluent Container

Sample Fill Line

Piccolo Features and Components 1-5

Piccolo Operator’s Manual

A sample diluent is sealed in a container inside the center of the disc. At the beginning of the reaction cycle, the analyzer opens the container and releases the diluent.

The analyzer separates a 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. Then centrifugal and capillary forces deliver the diluted sample to the cuvettes, where it dissolves the reagent beads and initiates the chemical reactions. Reaction products in the cuvettes are measured photometrically.

1.7.2 Disc storage and handling

• Store all reagent discs as described on their respective labels. When stored as described as described on their respective labels, all reagents in the disc are stable until the expiration date printed on the foil pouch and encoded on the bar code ring. The analyzer will reject an expired disc.

• A disc 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 aborts.

• Do not expose discs, in or out of the 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 may 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. A disc must be used within 20 minutes of opening the pouch. Once the pouch is opened, do not place the disc back in the refrigerator for use at a later time.

• Discs are fragile. Handle with care. Do not tap the disc on the table or work bench to empty the sample port. Do not use a disc that has been dropped.

• Keep discs clean. Handle them only at the edges to avoid smudges on the optical surfaces. Use a lint-free tissue to remove blood from the disc surface.

• Write the patient identification number on the disc surface in the space indicated in the figure to the right (optional). 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.

• The used disc can be replaced in the pouch for disposal.

• 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.

Write Patient ID

Here

1-6 Piccolo Features and Components

1.8 Result cards

Piccolo Operator’s Manual

Result cards are durable paper strips, about 7.5 inches long by

2.5 inches wide, designed for use with the Piccolo Chemistry Analyzer, on which test results and other information can be printed after testing is complete. Result cards are also used for printing the QC report and the troubleshooting report to assist in the interpretation of error codes. Additional copies of the result card can be printed at any time for any analysis held in memory. Refer to 2.2.2 and Section 4 for information about printing result cards, QC report cards, and troubleshooting reports. Refer to 1.13 for ordering information.

The result card has an adhesive backing so it can be placed into the patient’s file. The operator should follow the institution’s procedures for disposition of the result card.

Point-of-Care

1.9 Intelligent QC (iQC™)

The Piccolo® Point-of-Care Chemistry Analyzer includes design and user interface features that perform comprehensive system-wide quality control checks during each run. These features, collectively called “intelligent QC” (iQC™), ensure that operators at a wide range of skill levels can achieve accurate and reliable results. Two types of QC reagent beads (instrument and chemistry) are included in each disc. Refer to 1.7.1 for information about disc structure. When these methods confirm that all parameters are within expected ranges, INSTRU QC:OK CHEM QC:OK is printed on the result card. Otherwise, no result card is printed and an error message is displayed. Error messages indicate analyzer or disc malfunctions, and explain why results may not be available. Whenever an error message is displayed, refer to 5.6 for troubleshooting procedures.

System and chemistry QC data from each patient sample are stored in the analyzer memory with the sample results. System and chemistry QC data from each control run are stored with control results, separately from sample results. Standard information storage and retrieval techniques are employed to ensure the integrity of the data. All QC data stored in memory can be called up for review at any time. Refer to Section 4 for complete information and detailed instructions.

iQC™ greatly reduces the requirement for routine control testing. Refer to 2.4 for recommendations and procedure for control testing. Operators requiring assistance setting up control testing procedures should contact Abaxis Technical Support at 800-822-2947.

Piccolo Features and Components 1-7

Piccolo Operator’s Manual

1.9.1 Instrument iQC™

The analyzer hardware is subjected to a self-test at power-up. The self-test ensures that all optics, the flash lamp, and the circuit board components are functioning properly, and also verifies the memory functions. If any component does not meet specification, an error message is displayed. The disc motor, flash lamp, temperature, and optics are monitored continuously throughout each analysis. The spectrophotometer is automatically recalibrated at the beginning of each analysis.

Simultaneously with each analysis, advanced optical sensing and electronic systems monitor reactions involving instrument QC reagent beads to verify the functioning of the analyzer and the disc

1.9.2 Reagent iQC™

Reactions involving chemistry QC reagent beads reveal and quantify any degradation of the test-specific reagents in the disc due to suboptimal storage conditions. The value reported is the actual absorbance as a percent of the expected absorbance. The value must exceed a defined minimum for the reagents to meet performance standards. Otherwise, the run is aborted and an error message is displayed.

A lot-specific cutoff value for chemistry QC absorbance is used to separate the various tests on the disc into two groups, based on different sensitivity to heat exposure. If the chemistry QC value falls below this cutoff level but above the defined minimum, the results from the less heat-sensitive tests are expected to meet performance standards. The results of these tests are printed. The results of the more heat-sensitive tests may show some degradation and are suppressed. (This cutoff level is not printed on the quality control report.)

1.9.3 Performance iQC™

Disc checks performed during the analysis include: checking the barcode for current dating and for the presence of all required calibration factors; confirming that sample volume is sufficient; confirming the presence of all reagent beads and that all reagent beads have dissolved in diluted sample; verifying diluent and sample mixing; and monitoring fluid movement throughout the disc for proper sequence and timing of the reactions.

The iQC system monitors the performance of the reactions. For rate chemistries, the analyzer confirms that the reactions are linear; that the absorbances from which the rates are calculated, as well as the rates themselves, are within defined ranges; and whether the substrate has been depleted. In endpoint chemistries, the analyzer verifies that all measurements are within the dynamic range of the photometer and that the reaction has reached completion, ie, there are no changes in absorbance as a function of time.

The analyzer measure the levels of hemolysis, lipemia, and icterus. If there was interference with the analyte, information about the interference is printed on the result card. Refer to 2.3 for additional information.

1-8 Piccolo Features and Components

Piccolo Operator’s Manual

1.10 Setup and power supply

1.10.1 Shipping verification

Remove the analyzer from the shipping carton and place it on a level surface. Check the components you received against the following list.

• Piccolo

• Piccolo® Operator's Manual

• DC power adapter and connector cord

•AC power cord

• warranty card

Note: Fill out the warranty card and mail it to Abaxis within 10 days of system installation to start the warranty period. You will be put on the Abaxis customer list to receive any information pertaining to your analyzer and ancillary products, including product updates.

1.10.2 Powering up

• Use only the power supply components provided with the analyzer. Using other power supply components will damage the instrument and void the warranty.

• Connect the analyzer only to a grounded electrical outlet.

• To prevent power surges or drain, do not plug the analyzer into the same circuit as a centrifuge or any other high-current device. Alternatively, use an ancillary surge protector or uninterruptable power supply (UPS).

Point-of-Care Chemistry Analyzer

• Place the analyzer on a level surface free of vibration and sudden jolts, and where the ambient temperature is 15−32°C (59−90°F). Do not place it near a sunny window or other heat source.

• There should be at least 6 inches clearance behind the analyzer for access to the power connection and RS232 ports.

• Place the analyzer where airborne matter such as dust, lint, and hair is limited; ie, do not place it near a fan or where air circulation is high.

Step 1. Connect the power supply.

Refer to the figure at the right. Plug the DC adapter into the socket on the back of the analyzer. Connect the AC power cord to the DC adapter. Plug the AC power cord into a grounded electrical outlet. The self-test message will appear on the display. The self-test is described in 1.9.1. If the display is blank, check all power supply connections.

Performing self-test

Piccolo Features and Components 1-9

Piccolo Operator’s Manual

Step 2. Allow the analyzer to warm to operating temperature.

Depending on the ambient temperature, warming may take more time than the selftest.

⇒ The analyzer is in standby mode, i.e., ready to run a disc, when the display reads:

Open drawer to run a disc.

Step 3. Check the date and time.

Check the analyzer date and time to ensure they are correct. Refer to 3.3 to change the date and time.

Step 4. Link the analyzer to an external computer. (Optional)

Refer to 1.11.

Step 5. Perform control testing.

Perform one or more runs using recommended controls before running patient samples to confirm that the analyzer is functioning to specification. Refer to 2.4 for control run procedures.

1.10.3 Powering down

The power should remain on unless you are moving the analyzer to a new location. Always power down using the The

POWER key does not power down the analyzer when there is a reagent disc in the

drawer.

This message appears when the shutdown procedure and return the analyzer to standby mode.

Turn analyzer OFF? Press POWER/OFF to turn off, or EXIT to continue operation.

Press

POWER again to initiate system shutdown. The analyzer turns off when the sys-

tem shutdown is complete.

Performing system shutdown.

POWER key rather than by unplugging the analyzer.

POWER key is pressed. Press EXIT to cancel the system

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1.11 Connecting to an external computer

A facility may want to connect the analyzer to an external computer for any or all of the following reasons: to incorporate testing data into patient records; to provide records for regulatory compliance; or to connect with automated billing systems. By default, the analyzer does not transmit data, but it can be configured to transmit data in simple ASCII text, or in ASTM E 1394-97. Contact Abaxis for detailed information on connecting the analyzer to a computer.

1.12 Bar Code Scanner Option/Requirements

For ease of entry of patient identification, the Piccolo Point-of-Care Blood Analyzer can be used with any Bar Code Scanner that meets the following requirements:

1.12.1 Communication Interface

The communication interface must be a serial connection using a female 9-pin D-SUB connector. The TX (transmit) should be on pin 2, and the RX (receive) should be on pin 3.

1.12.2 Communication Parameters

Data is received at 9600 Baud, No Parity, 8 Bits, and 1 Stop Bit (9600,N,8,1).

1.12.3 Barcode Formats

The scanner should auto discriminate at a minimum Code 39 and Code 128 symbologies. There can be no preamble in the output data. The postamble in the output data shall have CR (Carriage Return [0x0D]), LF (Line Feed [0x0A]) and NULL [0x00]).

1.13 Consumables and ancillaries

Contact Abaxis or your authorized distributor to order reagent discs, result cards, controls, and sample collection equipment and supplies.

1.14 Customer service and technical support

Call Abaxis Customer Service and Technical Support at 800-822-2947 with questions regarding the operation the Piccolo

Point-of-Care Chemistry Analyzer.

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Section 2: Testing Procedure and

Interpretation of Results

2.1 Sample requirements

• The Piccolo® Point-of-Care Chemistry Analyzer accepts heparinized whole blood, heparinized plasma, or serum samples.

• Lithium heparin is the only anticoagulant recommended for use with the Piccolo® Point-of-Care Chemistry Analyzer.

• For use of the CLIA ‘88 Waived Lipid Panel Disc, the only sample that may be used is lithium heparinized whole blood.

• 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.

• If not analyzed immediately, plasma or serum (separated) may be stored at room temperature for no longer than 5 hours after centrifugation. If storage for more than 5 hours is required, the sample should be refrigerated in the stoppered tube at 2–8°C (36–46°F) for no longer than 48 hours; or stored at −10°C for up to 5 weeks in a freezer without a self-defrost cycle. Under these conditions, there will be no clinically important changes in most analyte concentrations.

• For accurate interpretation of results, the sample should be collected from a patient who has fasted for at least 12 hours (to avoid lipemic samples).

• Operator health and safety require that Universal Precautions be observed at all times while handling human blood samples or working with the Piccolo® Pointof-Care Chemistry Analyzer in any way. The complete text of the document “OSHA 29 CFR Part 1910, Occupational Exposure to Bloodborne Pathogens” can be found on the Internet at www.osha-slc.gov/Preamble/Blood_toc_by_sect.html.

2.2 Testing procedure

• Wear powder-free gloves while handling reagent discs or operating the analyzer. Powder may disrupt the optical components.

• If necessary, power up the analyzer before beginning the procedure. The power-up procedure is described in 1.10.2.

• Ensure that the ambient temperature is 15–32°C (59–90°F).

• The analyzer is in standby mode, i.e., ready to run a disc, when the display reads:

Open drawer to run a disc.

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2.2.1 Preparing the reagent disc

• Refer to 1.7 for complete information about Piccolo® reagent discs, including handling instructions. Please become thoroughly familiar with this information before beginning the procedure.

• Refer to 2.1 for sample handling and storage requirements.

• The analysis must begin immediately (no more than 10 minutes) after dispensing the sample into the reagent disc.

Step 1. Dispense the sample.

Use a micropipette (one is included with the Piccolo) or other transfer device to dispense approximately 100 µL of sample into the disc via the sample port.

Write Patient ID

Here

a. Fill the sample port.

Expel air bubbles from the tip of the micropipette. Place the micropipette in the sample port and tilt it until it is perpendicular to the disc

90 µL

surface. Push down on the plunger with a slow, continuous motion. Take care not to overfill the sample chamber. A

> 90 µL < 120 µL

100 µL sample will fill the sample chamber and form a line between the two arrows molded on the disc. More than 120 µL of sample will over-

<90 µL

fill the chamber, and less than 90 µL will underfill. Discard the pipette tip into a biohazard

> 120 µL

container.

b. Fill the sample chamber.

Tilt the disc to 45° with the sample port above the fill line, so that the entire sample flows into the sample chamber. Clean the reagent disc. Use a lint-free tissue to remove any sample spilled on the outside of the disc, taking care that the tissue does not withdraw any sample from the sample port. Dispose of the tissue in a biohazard container.

c. Carry the prepared disc to the analyzer.

Hold the disc by its edges in a flat position.

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2.2.2 Running a patient sample

• The analyzer must be in standby mode to begin the procedure.

• Use the numeric and arrow keys to enter patient, operator, and physician IDs while the analysis is proceeding. The → key inserts a dash; the ← key deletes the character to the left.

• The reference range set and patient, operator, and physician IDs must be entered before results can be calculated. If you wait until the run is complete before entering these numbers, the analyzer will require an additional one minute to calculate the results.

• If an error message is displayed at any time during the run, refer to 5.6 for troubleshooting procedures associated with the specific error code.

Step 2. Open the drawer and insert the disc.

Press

OPEN. The following messages are displayed

sequentially:

Opening drawer...

Close drawer to start analysis.

Place the disc in the drawer. Press

Closing drawer...

CLOSE. The display reads:

The analysis begins when the drawer closes.

Step 3. Select the reference range set.

By default, the reference range set for the previous sample is displayed. The reference range set for the current sample must be selected for correct interpretation of results. Use the numeric keys to select the correct reference range set. Press when the correct number appears to the right of Select.

Select:1 MALE 1- Male 3- Special 2- Female 4- Control ENTER to accept.

ENTER

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Step 4. Enter the patient ID.

A patient ID (up to 14 characters) must be entered to continue. Press

Input Patient #: _

_ _ _ _ _ _ _ _ _ _ _ _ _

ENTER when finished.

Step 5. Enter the operator ID.

Enter the operator ID for the current sample, up to 14 characters. Press

Input Operator #:

_ _ _ _ _ _ _ _ _ _ _ _ _

ENTER when finished.

Step 6. Enter the physician ID.

Enter the physician ID for the current sample, up to 14 characters. Press

Input DR #:

_ _ _ _ _ _ _ _ _ _ _ _ _

ENTER.

ENTER when finished.

Step 7. Automatic sample processing.

The analyzer processes the sample and calculates results in less than 13 minutes with no further operator input. During the run, the analyzer displays the following message, including time remaining to complete the analysis (XX:XX) and patient ID.

Results ready in XX:XX for patient #: XXXXXXXXXXXXXX

Sample processing is complete when the analyzer beeps and displays these messages sequentially:

Analysis complete. Open drawer or insert card to print results.

Insert card to print results.

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Step 8. Print results.

To end the procedure without printing results, press

If a Run Cancelled error message is displayed, refer to 5.6 for an explanation and further instructions.

Place the result card in the result card slot. Remove the card when directed to do so on the display. These messages appear sequentially:

Printing results...

Remove card.

Opening drawer...

EXIT and continue to step 9.

Remove disc and close drawer.

If the results card shows one or more rows of diamonds (♦♦♦) in place of analyte concentration, this indicates suppressed results. Refer to 2.3.2 B. In this situation, insert a second results card when prompted.

Step 9. Return the analyzer to standby mode.

Remove the reagent disc from the drawer and dispose of it, following your lab’s biohazard procedures. Press

CLOSE to return the analyzer to standby mode.

2.2.3 Canceling an analysis in progress

Press POWER to cancel an analysis in progress. The display requests verification that the analysis should be canceled:

Cancel analysis? POWER/OFF to cancel run, or EXIT to continue analysis.

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Press

POWER again to cancel the analysis. These messages appear sequentially:

Analysis canceled.

Opening drawer...

Remove disc and close drawer.

Remove the reagent disc from the drawer. Press

CLOSE to return the analyzer to

standby mode.

For the run cancellation to take effect, the operator must press

POWER before the ana-

lyzer has calculated the results. If the cancellation procedure is initiated after the analyzer has calculated the results, the cancellation will not take effect. The results are stored in memory and can be printed. The Analysis complete message appears. Continue from step 8, above.

Analysis complete. Open drawer or insert card to print results.

2.3 Interpreting patient results

Results are stored in internal memory, and, if the analyzer is connected to an external computer, automatically transmitted. Results can be printed on a result card. Refer to

2.2.2, Step 8. An adhesive backing allows the result card to be placed in the patient’s chart and become part of their permanent medical record. Refer to 1.8 for basic infor- mation about the result card. Follow your lab or facility’s procedure for transferring the card to the patient’s chart.

2.3.1 Reading the result card

The result card heading includes:

• test date and time

• reference range set

• patient, operator, and physician IDs; or control level

• reagent disc type and lot number

• analyzer serial number.

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The test results section of the card is printed in four columns:

•analyte

• analyte concentration

• units of measurement

• reference range in specified units.

An asterisk (*) printed to the right of the analyte concentration indicates results out- side the reference range.

A greater than (>) or less than (<) symbol printed to the left of the value in the analyte concentration column indicates results outside the dynamic range of the assay. Refer to 2.3.2 A., below.

is printed when the analyte concentration is lower than would normally be

expected (diluted sample).

A row of diamonds (♦♦♦) printed in place of analyte concentration indicates sup- pressed results. Refer to 2.3.2 B. below.

HEM, LIP, or ICT is printed in place of the analyte concentration when results are affected by interference from hemolysis, lipemia, or icterus. When a result is affected by hemolysis and either or both of the other interferents, HEM is printed. When a result is affected by both lipemia and icterus, LIP is printed. Examine the sample indices printed at the bottom of the card to determine if more than one interferent is affecting results. Refer to 2.3.2 C. below for further instructions.

INST QC: OK and CHEM QC: OK printed near the bottom of the result card when iQC testing indicates that all instrument, disc, and chemistry parameters meet specifications.

Sample indices for hemolysis, lipemia, and icterus are printed at the bottom of the card. The sample is rated for these interferents on the following scale:

0 clear 1+ slight 2+ moderate 3+ gross

2.3.2 Abnormal results: interpretation and further action

A. Results outside the dynamic range

Refer to the disc package insert for information about the dynamic range of any assay included in the disc. When the sample concentration falls below or exceeds the dynamic range of the assay, the analyzer cannot calculate the concentration. The numeric value that appears in the analyte concentration column is the upper or lower limit of the dynamic range of the assay, preceded by > or < , respectively. For example, the dynamic range of glucose is 10–700 mG/DL; a sample concentration of glucose below this range would be printed as <10 mG/DL; a sample concentration of glucose above this range would be printed as >700 mG/DL.

Results outside the dynamic range should be reported as below or above the value indicated.

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B. Suppressed results (♦♦♦)

A result may be suppressed when any of the internal QC steps detect an abnormal condition.

If a chemistry result (analyte) should be suppressed (♦♦♦), the analyzer prompts the operator to insert a print card to obtain the troubleshooting report. Hemolytic (HEM), lipemic (LIP), and icteric (ICT) are not considered chemistry suppressions.

Collect a new sample and rerun the test. If results for the second sample are suppressed, call Abaxis Technical Support at 800-822-2947 for further assistance.

C. Interferents

When the sample is hemolytic, collect a new sample and rerun the test. Abaxis recommends that the new sample be separated into serum or plasma so that the degree of hemolysis can be verified. If the new sample is hemolytic, use an alternative testing method or send the sample to a reference laboratory.

Samples with hematocrit in excess of 60% packed red cell volume may be reported on the result card as HEM. Follow the instructions above for retesting hemolyzed samples.

Lipemia may be due to diet. The patient should be instructed to fast for at least 10 to 12 hours before another sample is collected. For grossly lipemic samples from fasting patients or for icteric samples, use an alternative testing method or send a sample to another laboratory.

2.4 Running controls

Abaxis recommends control testing as follows:

• at least every 30 days

• whenever laboratory conditions have changed significantly

• when training or retraining of personnel is indicated

• when test results do not match patient symptoms or clinical findings

Good laboratory practices include the recording of the QC data according to the laboratory’s established written procedures. A permanent record of control results should be retained.

Samples and controls are run identically by the analyzer. However, using the Run Controls option in the Menu function stores control results separately from patient results in the analyzer memory. Control results can be printed on a result card immediately after the conclusion of the control run, or whenever the control run results are recalled. Refer to Section 4 for the use of the cally transmitted to a linked computer.

Handle the control as described in the control package insert. For assistance in interpreting control results, call Abaxis Technical Support at 800-822-2947.

RECALL key. Control results are automati-

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Piccolo Operator’s Manual

Step 1. Prepare the reagent disc.

Use a micropipette (provided with the Piccolo) or other transfer device to dispense approximately 100 µL of control into the sample port. Refer to 2.2.1 for detailed instructions on preparing the reagent disc.

Step 2. Press

OPEN.

The drawer opens and the following messages are displayed sequentially:

Opening drawer...

Close drawer to start analysis.

Insert the disc. Press

Closing drawer...

Step 3. Select Control, then press

Use the numeric keys to select Control. Press

Select:1 MALE 1- Male 3- Special 2- Female 4- Control ENTER to accept.

CLOSE. This message appears briefly:

ENTER.

Step 4. Choose the correct control level.

By default, the display shows the control level for the previous control run. Use the numeric keys to choose the correct control level for the current run. Press

ENTER.

Control Selection CONTROL LEVEL I 1-9 keys to change, ENTER to accept.

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Step 5. Enter the operator ID.

Enter the operator ID for the current control run, up to 14 characters. Press

Input Operator #: _

_ _ _ _ _ _ _ _ _ _ _ _ _

ENTER when finished.

Step 6. Enter the physician ID.

Enter the physician ID for the current run, up to 14 characters. Press

Input DR #:

_ _ _ _ _ _ _ _ _ _ _ _ _

ENTER when finished.

Step 7. Automatic control processing.

The analyzer displays the control level and time remaining for completing the analysis.

ENTER.

Results ready in XX:XX for control: LEVEL XXXX

When the analysis is complete, the analyzer beeps and displays these messages sequentially:

Analysis complete. Open drawer or insert card to print results.

Insert card to print results.

Step 8. Print control results.

If you choose not to print the results immediately following the control run, press

EXIT and continue with step 9.

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To print results immediately following the control run, insert a result card into the slot. This message is displayed while results are printing:

Printing results...

Remove the result card when directed to do so on the display. After the result card is removed, the drawer opens automatically. Proceed to step 9.

Remove card.

Step 9. Return the analyzer to standby mode.

Remove the reagent disc from the drawer and dispose of it according to your lab’s standard procedures. Press

CLOSE. The analyzer returns to standby mode.

2.5 Limitations of the procedure

• Refer to 5.6 when error messages are displayed.

• Samples with hematocrit in excess of 60% packed red cell volume may be reported on the result card as HEM. Refer to 2.3.2 C. for instructions.

• The analyzer suppresses results when the precision is significantly affected by hemolysis, lipemia, or icterus. Refer to 2.3.2 C.

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Section 3: The Menu Functions

Several special functions programmed into the Piccolo® Point-of-Care Chemistry Analyzer are accessed through the standby mode, i.e., when no analysis is in progress and the drawer is closed. From within any of these menus and functions, press Press

EXIT repeatedly to return to standby mode.

MENU key. The Menu functions are available from

EXIT to return to the previous display.

Function Description To access, press...

View analyzer ID View the analyzer serial number

MENU 3.2

and software version

Change date and time

Select date format Choose month/day/year or

Select time format Choose 12-hour or 24-hour clock

Customize reference ranges

Print reference ranges

Transmit reference ranges

Set the date and time

day/month/year

Set reference ranges for the specific patient population

Print the reference ranges in a specified set

Transmit all stored reference ranges to a linked computer

MENU two times,

then

ENTER

MENU two times,

then

ENTER, then

MENU two times,

then

ENTER, then

MENU two times

MENU three times,

then

ENTER

MENU three times,

then

ENTER, then

MENU three times,

then

ENTER, then

MENU two times

Refer to...

3.3

3.4

3.5

3.6

3.7

3.8

Select language Select 1 of 5 languages

Select units Choose international units (SI) or

units commonly used in the United States

Select data format Select the format used for serial

data output

MENU four times 3.9

MENU four times,

then

ENTER, then

MENU four times,

then

ENTER, then

MENU two times

3.10

3.11

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Piccolo Operator’s Manual

3.1 Accessing a particular special function

The Menu functions can be used only when the analyzer is in standby mode (the message Open a drawer to run a disc appears in the display). To access the menus or functions needed, press

Step 1. Begin from the standby mode display.

Open drawer to run a disc.

MENU and ENTER as shown in this section.

Step 2. Press

Press ENTER to view analyzer ID, MENU for next option EXIT to leave.

Step 3. Press

Press ENTER for date & time menus, MENU for next option EXIT to leave.

Step 4. Press

Press ENTER for reference range menu MENU for next option EXIT to leave.

Step 5. Press

Press ENTER for analyzer setup menu MENU for next option EXIT to leave.

MENU.

MENU a second time.

MENU a third time.

MENU a fourth time.

Step 6. Press

MENU again to return to the first display.

Press ENTER to view analyzer ID, MENU for next option EXIT to leave.

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Piccolo Operator’s Manual

Step 7. Press

EXIT to return to standby mode.

Open drawer to run a disc.

3.2 Viewing analyzer identification

Use this Menu function to verify the serial number of the analyzer and the version number of its installed software.

Step 1. Access the View Analyzer ID function.

From standby mode, press

Press ENTER to view analyzer ID, MENU for next option EXIT to leave.

Step 2. Display the serial number and software version.

Press

ENTER.

Serial #: XXXXXXXXXX Software Version: X.XXX Press ENTER.

MENU.

Step 3. Press

EXIT to return to the View Analyzer ID function, or press EXIT twice to

return to standby mode.

NOTE: The software version also appears on-screen while the analyzer is starting up.

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Piccolo Operator’s Manual

3.3 Changing the date and time

The date and time are checked during the set up procedure. Refer to 1.10.2, Step 3. Adjust as needed.

NOTE: If needed, change the date or time format before changing the date or time. Refer to 3.4 and 3.5.

Step 1. Access the Date & Time menu.

From standby mode, press

Press ENTER for date & time menus, MENU for next option EXIT to leave.

Step 2. Access the Change Date & Time function.

Press

ENTER.

Press ENTER to change date & time, MENU for next option EXIT to leave.

MENU twice

Step 3. Display the date or time in the current format.

Press

ENTER.

Select:2 Time xx/xx/xx xx:xx XM 1-Date 2-Time ENTER to accept.

Step 4. Select the date.

Press 1, then

ENTER.

Date: xx/xx/xx 0-9 keys to change,

←, → to move cursor,

ENTER to accept.

Step 5. Change the date.

Use ← → and the numeric keys to enter the correct date. Press

Select:2 Time xx/xx/xx xx:xx XM 1- Date 2-Time ENTER to accept.

ENTER to accept.

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Step 6. Select the time.

Press

ENTER.

Time: xx:xx:xx XM 0-9 keys to change,

←, → to move cursor,

ENTER to accept.

Step 7. Change the time.

Use ← → and the numeric keys to enter the correct time. If the 12-hour clock option is active, press 1 or 2 to select not appear on the screen. Refer to 3.4.)

Time: xx:xx:xx XM 1 for AM, 2 for PM,

←, → to move cursor,

ENTER to accept.

Step 8. Verify the date and time settings.

ENTER. If the date or time entered is valid, the following is displayed. (To make

Press more changes, press 1 or 2, then

AM or PM. (If the 24-hour clock is active, this option will

ENTER, and repeat the above from Step 4 or Step 6.)

Select:2 Time xx/xx/xx xx:xx XM 1- Date 2-Time ENTER to accept.

If an invalid date (such as 14 for the month) or time (30 for hours) was entered, one of the following messages appears:

Entry for date was invalid. Enter date value again. Press EXIT.

If needed, press

Step 9. Press

EXIT once to return to the Change Date & Time function, twice to

EXIT, return to Step 4 or Step 6, then correct the date or time.

Entry for time was invalid. Enter time value again. Press EXIT.

return to the Date & Time menu, or three times to return to standby mode.

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3.4 Selecting the date format

Two options are available: month/day/year, and day/month/year.

Step 1. Access the Date & Time menu.

Press

MENU twice.

Press ENTER for date & time menus, MENU for next option EXIT to leave.

Step 2. Access the Select Date Format function.

Press

ENTER, then MENU.

Press ENTER to select date format, MENU for next option EXIT to leave.

Step 3. Choose the date format.

Press

ENTER to display the current date format. Press 1 or 2 to change the format.

Select:1 MM/DD/YY 1-MM/DD/YY 05/16/04 2-DD/MM/YY 16/05/04 ENTER to accept.

Press

ENTER to accept the format and return to the Select Date Format function (shown

in Step 2).

Step 4. Press

EXIT once to return to the Date & Time menu, or twice to return to

standby mode.

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3.5 Selecting the time format

Two options are available: 12-hour clock and 24-hour clock.

Step 1. Access the Date & Time menu.

From standby mode, press

Press ENTER for date & time menus, MENU for next option EXIT to leave.

Step 2. Access the Select Time Format function.

Press

ENTER, then press MENU twice.

Press ENTER to select time format, MENU for next option EXIT to leave.

Step 3. Choose the time format.

Press

ENTER to display the current time format. Press 1 or 2 to change the format.

MENU twice

Select:1 XX HOUR 1-12 hour 04:19 PM 2-24 hour 16:19 ENTER to accept.

Press

ENTER to accept the format and return to the Select Time Format function

(shown in Step 2).

Step 4. Press

EXIT once to return to the Date & Time menu, or twice to return to

standby mode.

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3.6 Customizing reference ranges

Change the analyzer’s reference ranges to match the specific reference ranges for the patient population.

NOTE: Change reference ranges in common units or in SI units, not both. The analyzer automatically converts units.

NOTE: If the lower and upper ranges are both 0 for a specific method, the reference ranges will not print for that method.

Step 1. Access the Reference Range menu.

From standby mode, press

Press ENTER for reference range menu MENU for next option EXIT to leave.

Step 2. Access the Edit Reference Ranges function.

Press

ENTER.

MENU three times.

Press ENTER to edit reference ranges, MENU for next option EXIT to leave.

Step 3. Select the method (analyte).

Press

ENTER to display the current method. Use ← → to choose a different method.

Press

ENTER to accept.

Select Method: XXXX

Press

←, → to scan,

ENTER to accept.

Step 4. Select the reference range set.

Use the numeric keys to select a set. Press

Select:1 MALE 1-Male 3-Special 2-Female 4-Control ENTER to accept.

ENTER to accept.

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Piccolo Operator’s Manual

Step 5. Special and Control reference ranges only: select the range.

Use the numeric keys to select the reference range. Press

ENTER.

Special Selection SPECIAL XX 1-9 keys to change, ENTER to accept.

Control Selection CONTROL LEVEL XX 1-9 keys to change, ENTER to accept.

Step 6. Change the reference range values.

The current method (analyte) and its reference range set and values are displayed. Use ← → and the numeric keys to change the range values.

<method> <gender> <range> <unit> 0-9 keys to change, ENTER to accept.

Step 7. Verify reference range settings.

Make sure the settings are correct. Press

ENTER to accept. If the range values are valid,

the following is displayed.

Select Method: XXXX

Press

←, → to scan,

ENTER to accept.

If an invalid value was entered, the following is displayed. Press

EXIT. The reference

range changes are discarded. Repeat Step 6 with valid data.

Reference range entry not valid.

Press EXIT.

Step 8. Change the reference ranges for other methods (analytes).

Repeat Step 3 through Step 7 as needed.

Step 9. Print and the verify reference ranges.

Verify the reference ranges by printing them on a result card: from the screen shown below, press

EXIT, then MENU to bring up the Print Reference Ranges function (refer to

3.7).

Select Method: XXXX

Press

←, → to scan,

ENTER to accept.

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Piccolo Operator’s Manual

NOTE: The date and time shown on the card refer to when the card was printed, not when the reference ranges were changed. To record the date the ranges were changed, write it on the card.

Step 10.Press

EXIT once to return to the Print Reference Ranges function, twice to

return to the Reference Range menu, or three times to return to standby mode.

3.7 Printing reference ranges

Print the reference ranges for a specific reference range set.

NOTE: To print reference ranges, lower and upper ranges must be greater than 0.

NOTE: The date and time shown on the card refer to when the card was printed, not when the reference ranges were changed. To record the date the ranges were changed, write it on the card.

Step 1. Access the Reference Range menu.

From standby mode, press

Press ENTER for reference range menu MENU for next option EXIT to leave.

Step 2. Access the Print Reference Ranges function.

Press

ENTER, then MENU.

Press ENTER to print reference ranges, MENU for next option EXIT to leave.

MENU three times.

Step 3. Select the reference range set to print.

Press

ENTER. Use the numeric keys to select the reference range set. Press ENTER.

Select:1 MALE 1-Male 3-Special 2-Female 4-Control ENTER to accept.

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Step 4. Special and Control reference ranges only: select the range.

Use the numeric keys to select the reference range. Press

ENTER.

Special Selection SPECIAL XX 1-9 keys to change, ENTER to accept.

Control Selection CONTROL LEVEL XX 1-9 keys to change, ENTER to accept.

Step 5. Print the reference range set.

Make sure the correct reference range set is displayed. Insert a result card. Follow the instructions on the display.

Insert card to print XXXXXXXXXXXXXXX reference ranges or EXIT to quit.

Printing ranges...

Remove card.

Step 6. Print additional reference ranges.

After the card is removed, the following display is shown. Repeat Step 3 through Step 5 as needed.

Select:1 MALE 1-Male 3-Special 2-Female 4-Control ENTER to accept.

Step 7. Press

EXIT once to return to the Print Reference Ranges function, twice to

return to the Reference Range menu, or three times to return to standby mode.

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3.8 Transmitting reference ranges

The reference ranges stored in the analyzer memory can be transmitted to a linked computer. Refer to 1.11 for instructions for linking to an external computer.

NOTE: The date and time recorded are when the transmission was made, not when the reference ranges were changed.

Step 1. Access the Reference Range menu.

From standby mode, press

Press ENTER for reference range menu MENU for next option EXIT to leave.

Step 2. Access the Transmit Reference Ranges function.

Press

ENTER, then press MENU twice.

ENTER to transmit reference ranges, MENU for next option EXIT to leave.

MENU three times.

Step 3. Select the reference range set to transmit.

Press

ENTER. Use the numeric keys to select the reference range set. Press ENTER.

Select:1 MALE 1-Male 3-Special 2-Female 4-Control ENTER to accept.

Step 4. Special and Control reference ranges only: select the range.

Use the numeric keys to select the reference range.

Special Selection SPECIAL XX 1-9 keys to change, ENTER to accept.

Control Selection CONTROL LEVEL XX 1-9 keys to change, ENTER to accept.

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Step 5. Transmit the reference range set.

Press

ENTER. During the transmission, the following is displayed.

Transmitting ranges to computer.

Step 6. Transmit additional reference ranges

After the transmission, the following display is shown. Repeat Step 3 through Step 5 as needed.

Select:1 MALE 1-Male 3-Special 2-Female 4-Control ENTER to accept.

Step 7. Press

EXIT once to return to the Transmit Reference Ranges function, twice

to return to the Reference Range menu, or three times to return to standby mode.

3.9 Selecting a language

Five languages are available: English, French, German, Spanish, and Italian.

Step 1. Access the Analyzer Setup menu.

From standby mode, press

Press ENTER for analyzer setup menu MENU for next option EXIT to leave.

Step 2. Access the Select Language function.

Press

ENTER.

Press ENTER to Select language, MENU for next option EXIT to leave.

MENU four times.

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Step 3. Accept or change the current language.

Press

ENTER to display the current language. Use ← → to select another language.

Press

ENTER to accept.

Select language ENGLISH

←, → to change,

ENTER to accept.

Sprache wählen DEUTSCH

←, → -ändern

ENTER - bestätigen

Selez. Lingua ITALIANO

Select. langue FRANCAIS

←, → pour modifier,

ENTER pour valider.

Selec. Idioma ESPANOL

←, → para cambiar,

ENTER para aceptar

←, → modificare,

ENTER per accettare

Step 4. Press

EXIT once to return to the Analyzer Setup menu, or twice to return to

standby mode.

3.10 Selecting units

Two options are available for reporting results: common units (e.g., mg/dL) or SI units (e.g., mmol / L).

Step 1. Access the Analyzer Setup menu.

From standby mode, press

MENU four times.

Press ENTER for analyzer setup menu MENU for next option EXIT to leave.

Step 2. Access the Select Units function.

Press

ENTER, then MENU.

Press ENTER to select units, MENU for next option EXIT to leave.

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Step 3. Accept or change the current option.

Press

ENTER to display the current units. Press ← → to change the units. Press ENTER to

accept.

Common Units

←, → to change,

ENTER to accept.

Step 4. Press

EXIT once to return to the Analyzer Setup menu, or twice to return to

SI (Int’l) units

←, → to change

ENTER to accept.

standby mode.

3.11 Selecting the data format

Three options are available for the format used to transmit data: ASTM E 1394-97, ASCII text dump, or none.

Step 1. Access the Analyzer Setup menu.

From standby mode, press

Press ENTER for analyzer setup menu MENU for next option EXIT to leave.

Step 2. Access the Set Data Format function.

Press

ENTER, then press MENU twice.

MENU four times.

Press ENTER to set data format, MENU for next option EXIT to leave.

Step 3. Accept or change the current option.

Press

ENTER to display the current data format. Press ← → to change the format. Press

ENTER to accept.

Serial Data Output NONE ←, → to change, ENTER to accept.

Step 4. Press

EXIT once to return to the Analyzer Setup menu, or twice to return to

Serial Data Output ASTM E 1394-97

←, → to change, ENTER to accept.

Serial Data Output

ASCII Text Dump ←, → to change, ENTER to accept.

standby mode.

NOTE: The transmit portions of the

RECALL menus and reference range transmission are

available only when ASCII Text Dump is selected.

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Section 4: The Recall Function

The RECALL key allows access to patient results, control results, and system QC data stored in the analyzer memory. The analyzer memory stores the results for the last 70 patient samples and the last 70 control samples, in reverse chronological order. (Refer to 1.9 for information about system QC data.) Results or system QC for a specified sample or control that remains in memory can be recalled using run-specific parameters, or by viewing the entries in chronological order.

Note that results stored on an external computer must be accessed through the computer.

The Recall menus and functions are available from standby mode, i.e., when no analysis is in progress and the drawer is closed. They cannot be accessed from the Menu functions. From within any of these menus and functions, press previous display. Press

EXIT repeatedly to return to standby mode

• Use the numeric and arrow keys to enter patient, operator, and physician IDs. The → key functions as a dash; the ← key functions as a backspace (delete key).

•The message No results in memory may be displayed if the analyzer mem- ory has been cleared during servicing. If it appears at any other time, refer to 5.6 for troubleshooting procedures under the error code number.

EXIT to return to the

4.1 Viewing or printing patient records

Use the following procedure to view or print selected patient result records, quality control records, or error flag records.

Step 1. Access the Recall Results menu.

From standby mode, press

Press ENTER to Recall Results MENU for next option EXIT to leave.

Step 2. Access the Recall Patient Results function.

Press

ENTER.

Recall patient results

←, → to change,

ENTER to accept.

RECALL.

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Step 3. Select the type of records to view.

Use the ← → keys to select patient result records, iQC records, or flag records.

Recall patient results ←, → to change, ENTER to accept.

Press

ENTER to accept. One of the following appears, depending on the selection

Recall:1 Single 1-Single result card 2-All patients ENTER to accept.

Recall patient iQC ←, → to change, ENTER to accept.

Recall:1 Single 1-Single iQC card 2-All patient iQC ENTER to accept.

Recall patient flags ←, → to change, ENTER to accept.

Recall:1 Single 1-Single flag card 2-All patient flags ENTER to accept.

Step 4. Choose a specific patient result record, iQC record, or flag record.

Press 1,

ENTER.

Select:1 Print 1-Print result card 2-Transmit patient ENTER to accept.

Select:1 Print 1-Print iQC card 2-Transmit patient ENTER to accept.

Select:1 Print 1-Print flag card 2-Transmit patient ENTER to accept.

Step 5. Accept the print option.

Press 1,

ENTER. By default, the patient ID, date, and time of the most recent record are

displayed.

Pt # XXXXXXXXXXXXXX xx/xx/xx xx:xxXM

to view results,

←, →

ENTER to print.

Pt # XXXXXXXXXXXXXX xx/xx/xx xx:xxXM

to view iQC,

←, →

ENTER to print.

Pt # XXXXXXXXXXXXXX xx/xx/xx xx:xxXM

to view flags,

←, →

ENTER to print.

NOTE: If the analyzer has no records in memory, one of the following appears instead. Press

ENTER to return to Step 1.

No patient results found.

Press ENTER.

No patient iQC found.

Press ENTER.

No patient flags found.

Press ENTER.

Step 6. View or search for patient records.

Patient records can be viewed sequentially, or located by patient ID.

• To view records sequentially:

Use ←→ to view the records. The records are stored in reverse chronological order, so ← shows older records, and → shows newer records. The analyzer beeps twice when there are no more records to view.

Find the record to be printed, then proceed with Step 7, below. To exit without printing, press

EXIT.

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• To search for records by patient ID:

Press

RECALL.

Search for patient # _

_ _ _ _ _ _ _ _ _ _ _ _ _

ENTER to search.

Use the numeric keys to enter the patient ID. Use ← to erase displayed characters, and → to enter a dash (–). Press

If any records have a matching patient ID, the analyzer displays the patient ID number, date, and time of the most recent matching result, along with the number of the record displayed (nnn, below), and the total number of records found (ttt). Use ←→ to find the record of interest.

Pt.# XXXXXXXXXXXXXX xx/xx/xx xx:xxXm

nnn of ttt, view, ENTER to print.

←, → to

ENTER to search.

If no matching records are found, the following is displayed.

Pt.# XXXXXXXXXXXXXX not found.

Press ENTER.

If this occurs, press

ENTER, make sure the patient ID is correct (or choose another

ID), and search again.

Step 7. Print the patient record.

Press

ENTER, and follow the displayed instructions. (If a computer is connected to the

analyzer, record data are automatically transmitted to the computer. Refer to 1.11.)

Insert card to print results.

Printing results...

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Remove card.

Step 8. Print additional records.

To print additional records, return to Step 6 on page 4-2.

Step 9. Return to standby mode.

Press

EXIT repeatedly until “Open drawer to run a disc” is displayed.

4.2 Viewing or printing control records

Use the following procedure to view or print selected control result records, iQC records, or flag records.

Step 1. Access the Recall Controls menu.

From standby mode, press

RECALL, MENU.

Press ENTER to Recall Controls MENU for next option EXIT to leave.

Step 2. Access the Recall Control Results function.

Press

ENTER.

Recall control results

←, → to change,

ENTER to accept.

Step 3. Select the type of records to view.

Use the ← → keys to select control result records, iQC records, or flag records.

Recall control results ←, → to change, ENTER to accept.

Press

ENTER to accept. One of the following appears, depending on the selection

Recall:1 Single 1-Single result card 2-All controls ENTER to accept.

Recall control iQC ←, → to change, ENTER to accept.

Recall:1 Single 1-Single iQC card 2-All control iQC ENTER to accept.

Recall control flags ←, → to change, ENTER to accept.

Recall:1 Single 1-Single flag card 2-All control flags ENTER to accept.

Step 4. Choose to print a single control result record, iQC record, or flag record.

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Press 1,

ENTER.

Select:1 Print 1-Print result card 2-Transmit control ENTER to accept.

Select:1 Print 1-Print iQC card 2-Transmit control ENTER to accept.

Select:1 Print 1-Print flag card 2-Transmit control ENTER to accept.

Step 5. Accept the print option.

Press 1,

ENTER. By default, the control level, date, and time of the most recent record

are displayed.

Control level XX xx/xx/xx xx:xxXM

to view results,

←, →

ENTER to print.

Control level XX xx/xx/xx xx:xxXM

to view iQC,

←, →

ENTER to print.

Control level XX xx/xx/xx xx:xxXM

to view flags,

←, →

ENTER to print.

NOTE: If the analyzer has no records in memory, one of the following appears instead. Press

ENTER to return to Step 1.

No control results found.

Press ENTER.

No control iQC found.

Press ENTER.

No control flags found.

Press ENTER.

Step 6. View or search for control records.

Control records can be viewed sequentially, or located by date.

• To view records sequentially:

Find the record to be printed, then proceed with Step 7. To exit without printing, press

EXIT.

• To search for records by date:

Press

RECALL.

Search for control results on xx/xx/xx Edit date, ENTER to search.

Use the numeric keys to enter the date. Use ← to erase displayed characters, and → to enter a dash (–). Press

ENTER to search.

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Piccolo Operator’s Manual

If any records have a matching date, the analyzer displays the control level, date, and time of the most recent matching record, along with the number of the record displayed (nnn, below), and the total number of records found (ttt). Use ←→ to find the record of interest.

Control level XX xx/xx/xx xx:xxXm

nnn of ttt, view, ENTER to print.

If no matching records are found, the following is displayed.

No control results found on xx/xx/xx

Press ENTER.

←, → to

If this occurs, press

ENTER, make sure the date is correct (or choose another date),

and search again.

Step 7. Print the control record.

Press

ENTER, and follow the displayed instructions. (If a computer is connected to the

analyzer, the records is automatically transmitted to the computer. Refer to 1.11.)

Insert card to print results.

Printing results...

Remove card.

Step 8. Print additional records.

To print additional records, return to Step 6 on page 4-5.

Step 9. Return to standby mode.

Press

EXIT repeatedly until “Open drawer to run a disc” is displayed.

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Piccolo Operator’s Manual

4.3 Viewing or printing error records

Use the following procedure to print errors record.

Step 1. Access the Recall Errors function.

From standby mode, press

Press ENTER to Recall Errors MENU for next option EXIT to leave.

Step 2. Recall a single error record.

Press

ENTER.

Recall:1 Single 1-Single error card 2-All errors ENTER to accept.

Step 3. Choose to print a single error.

Press 1,

ENTER.

RECALL, then press MENU twice.

Select:1 Print 1-Print error card 2-Transmit errors ENTER to accept.

Step 4. Accept the print option.

Press 1,

ENTER. By default, the error level, date, and time of the most recent record are

displayed.

Pt. # LEVEL XX xx/xx/xx xx:xxXM

←, →

to view results,

ENTER to print.

NOTE: If the analyzer has no records in memory, the following appears instead. Press to return to Step 1.

No error results found.

Press ENTER.

Step 5. View the error records.

ENTER

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Use the ←→ keys to view the records. The records are stored in reverse chronological order, so ← shows older records, and → shows newer records. The analyzer beeps twice when there are no more records to view.

Find the record to be printed, then proceed with Step 6. To exit without printing, press

EXIT.

Step 6. Print the error record.

Press

ENTER, and follow the displayed instructions. (If a computer is connected to the

analyzer, the record is automatically transmitted to the computer. Refer to 1.11.)

Insert card to print results.

Printing results...

Remove card.

Step 7. Print additional records.

To print additional records, return to Step 5, above.

Step 8. Return to standby mode.

Press

EXIT repeatedly until “Open drawer to run a disc” is displayed.

4.4 Transmitting patient records

Use the following procedure to transmit patient result records, quality control records, or error flag records to a connected computer.

NOTE: Transmitting all records is recommended before reinitializing the analyzer’s software, or before returning the analyzer to Abaxis for service.

Step 1. Access the Recall Results menu.

From standby mode, press

Press ENTER to Recall Results MENU for next option EXIT to leave.

RECALL.

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Piccolo Operator’s Manual

Step 2. Access the Recall Patient Records function.

Press

ENTER.

Recall patient results

←, → to change,

ENTER to accept.

Step 3. Select the type of patient records to transmit.

Use the ← → keys to select patient result records, iQC records, or flag records.

Recall patient results ←, → to change, ENTER to accept.

Press

ENTER to accept. One of the following appears, depending on the selection

Recall:1 Single 1-Single result card 2-All patients ENTER to accept.

Recall patient iQC ←, → to change, ENTER to accept.

Recall:1 Single 1-Single iQC card 2-All patient iQC ENTER to accept.

Recall patient flags ←, → to change, ENTER to accept.

Recall:1 Single 1-Single flag card 2-All patient flags ENTER to accept.

Step 4. To transmit a single patient record:

NOTE: To transmit all patient records, go to Step 5 on page 4-10.

a. Press 1,

b. Press 2,

ENTER.

Select:1 Print 1-Print result card 2-Transmit patient ENTER to accept.

Select:1 Print 1-Print iQC card 2-Transmit patient ENTER to accept.

Select:1 Print 1-Print flag card 2-Transmit patient ENTER to accept.

ENTER. By default, the patient ID, date, and time of the most recent record

are displayed.

Pt # XXXXXXXXXXXXXX xx/xx/xx xx:xxXM

to view results,

←, →

ENTER to transmit.

Pt # XXXXXXXXXXXXXX xx/xx/xx xx:xxXM

to view iQC,

←, →

ENTER to transmit.

Pt # XXXXXXXXXXXXXX xx/xx/xx xx:xxXM

←, →

ENTER to transmit.

to view flags,

NOTE: If the analyzer has no results in memory, one of the following appears instead. Press

ENTER to return to Step 1.

No patient results found.

Press ENTER.

No patient iQC found.

Press ENTER.

No patient flags found.

Press ENTER.

c. View the records sequentially, or search for a particular record by patient ID.

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Piccolo Operator’s Manual

• To view records sequentially:

Find the record to be transmitted, then proceed with Step 6. To exit without transmitting, press

• To search for records by patient ID:

Press

RECALL.

Search for patient # _

_ _ _ _ _ _ _ _ _ _ _ _ _

ENTER to search.

Use the numeric keys to enter the patient ID. Use ← to erase displayed characters, and → to enter a dash (–). Press

EXIT.

ENTER to search.

Pt.# XXXXXXXXXXXXXX xx/xx/xx xx:xxXm nnn of ttt, ENTER to transmit.

←, → view

If no matching records are found, the following is displayed.

Pt.# XXXXXXXXXXXXXX not found.

Press ENTER.

If this occurs, press

ENTER, make sure the patient ID is correct, and search again.

d. Go to Step 6, below.

Step 5. To transmit all patient records:

a. Press 2,

ENTER.

Transmit all patient results ENTER to transmit EXIT to leave.

Transmit all patient iQC ENTER to transmit EXIT to leave.

Transmit all patient flags ENTER to transmit EXIT to leave.

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Step 6. Transmit the record or records.

Press

ENTER. One of the following appears while the record is being transmitted.

Transferring data to computer.

Transmitting results...

Step 7. Transmit additional records.

To transmit additional records, return to Step 4 on page 4-9.

Step 8. Return to standby mode.

Press

EXIT repeatedly until “Open drawer to run a disc” is displayed.

4.5 Transmitting control records

Use the following procedure to transmit control results records, iQC records, or flag records to a connected computer.

NOTE: Transmitting all records is recommended before reinitializing the analyzer’s software, or before returning the analyzer to Abaxis for service.

Step 1. Access the Recall Controls menu.

From standby mode, press

Press ENTER to Recall Controls MENU for next option EXIT to leave.

RECALL, MENU.

Step 2. Access the Recall Control Results function.

Press

ENTER.

Recall control results

←, → to change,

ENTER to accept.

Step 3. Select the type of control records to transmit.

Use the ← → keys to select control result records, iQC records, or flag records.

Recall control results ←, → to change, ENTER to accept.

Recall control iQC ←, → to change, ENTER to accept.

Recall control flags ←, → to change, ENTER to accept.

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Piccolo Operator’s Manual

Press

ENTER to accept. One of the following appears, depending on the selection

Recall:1 Single 1-Single result card 2-All controls ENTER to accept.

Recall:1 Single 1-Single iQC card 2-All control iQC ENTER to accept.

Recall:1 Single 1-Single flag card 2-All control flags ENTER to accept.

Step 4. To transmit a single control record:

NOTE: To transmit all control records, go to Step 5 on page 4-13.

a. Press 1,

b. Press 2,

ENTER.

Select:1 Print 1-Print result card 2-Transmit control ENTER to accept.

Select:1 Print 1-Print iQC card 2-Transmit control ENTER to accept.

Select:1 Print 1-Print flag card 2-Transmit control ENTER to accept.

ENTER. By default, the control level, date, and time of the most recent

record are displayed.

Control level XX xx/xx/xx xx:xxXM

←, →

to view results,

ENTER to transmit.

Control level XX xx/xx/xx xx:xxXM

←, →

to view iQC,

ENTER to transmit.

Control level XX xx/xx/xx xx:xxXM

←, →

to view flags,

ENTER to transmit.

NOTE: If the analyzer has no records in memory, one of the following appears instead. Press

ENTER to return to Step 1.

No patient results found.

Press ENTER.

No patient iQC found.

Press ENTER.

No patient flags found.

Press ENTER.

c. View the records sequentially, or search for a particular record by date.

• To view records sequentially:

Find the record to be transmitted, then proceed with Step 6. To exit without transmitting, press

EXIT.

• To search for records by date:

Press

RECALL.

Search for control results on xx/xx/xx Edit date, ENTER to search.

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Piccolo Operator’s Manual

Use the numeric keys to enter the date. Use ← to erase displayed characters, and → to enter a dash (–). Press

If any records have a matching date, the analyzer displays the control level, date, and time of the most recent matching result, along with the number of the record displayed (nnn, below), and the total number of records found (ttt). Use ←→ to find the particular record of interest.

Control level XX

xx/xx/xx xx:xxXm nnn of ttt, ENTER to transmit.

←, → view

If no matching records are found, the following is displayed.

No control results found on xx/xx/xx

Press ENTER.

ENTER to search.

If this occurs, press

ENTER, make sure the date is correct (or enter another date),

and search again.

d. Go to Step 6, below.

Step 5. To transmit all control records:

a. Press 2,

ENTER.

Transmit all control results ENTER to transmit EXIT to leave.

Transmit all control iQC ENTER to transmit EXIT to leave.

Transmit all control flags ENTER to transmit EXIT to leave.

Step 6. Transmit the record or records.

Press

ENTER. One of the following appears while the record is being transmitted.

Transferring data to computer.

Transmitting results...

Step 7. Transmit additional records.

To transmit additional records, return to Step 4 on page 4-12.

Step 8. Return to standby mode.

Press

EXIT repeatedly until “Open drawer to run a disc” is displayed.

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4.6 Transmitting error records

Use the following procedure to transmit error records to a connected computer.

NOTE: Transmitting all records is recommended before reinitializing the analyzer’s software, or before returning the analyzer to Abaxis for service.

Step 1. Access the Recall Errors function.

From standby mode, press

Press ENTER to Recall Errors MENU for next option EXIT to leave.

Step 2. Recall the error records.

Press

ENTER.

Recall:1 Single 1-Single error card 2-All errors ENTER to accept.

RECALL, then press MENU twice.

Step 3. To transmit a single error record:

NOTE: To transmit all error records, go to Step 4 on page 4-16.

a. Press 1,

b. Press 2,

ENTER.

Select:1 Print 1-Print error card 2-Transmit errors ENTER to accept.

ENTER. By default, the error level, date, and time of the most recent record

are displayed.

Pt.# LEVEL XX xx/xx/xx xx:xxXM

←, → to view results,

ENTER to transmit.

NOTE: If the analyzer has no records in memory, the following appears instead. Press to return to Step 1.

No error results found.

Press ENTER.

ENTER

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c. View the records sequentially, or search for a particular record by date.

• To view records sequentially:

Use the ←→ keys to view the records. The records are stored in reverse chrono- logical order, so ← shows older records, and → shows newer records. The analyzer beeps twice when there are no more records to view.

Find the record to be transmitted, then proceed with Step 5 on page 4-16. To exit without transmitting, press

• To search for records by date:

Press

RECALL.

Search for errors results on xx/xx/xx Edit date, ENTER to search.

Use the numeric keys to enter the date. Use ← to erase displayed characters, and → to enter a dash (–). Press

EXIT.

ENTER to search.

If any records have a matching date, the analyzer displays the error level, date, and time of the most recent matching result, along with the number of the record displayed (nnn, below), and the total number of records found (ttt). Use ←→ to find the particular record of interest.

Pt.# LEVEL XX xx/xx/xx xx:xxXm nnn of ttt, ENTER to transmit.

←, → view

If no matching records are found, the following is displayed.

No error results found on xx/xx/xx

Press ENTER.

If this occurs, press

ENTER, make sure the date is correct (or enter another date),

and search again.

d. Go to Step 5, below.

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Piccolo Operator’s Manual

Step 4. To transmit all error records:

Press 2,

Step 5. Transmit the record or records.

Press

ENTER.

Transmit all errors ENTER to transmit EXIT to leave.

ENTER. One of the following appears while the data is being transmitted.

Transferring errors to computer.

Transmitting results...

Step 6. Transmit additional records.

To transmit additional records, return to Step 3 on page 4-14.

Step 7. Return to standby mode.

Press

EXIT repeatedly until “Open drawer to run a disc” is displayed.

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Section 5: Maintenance and Troubleshooting

5.1 Routine maintenance

The Piccolo® Point-of-Care Chemistry Analyzer requires no scheduled servicing. Maintenance of the analyzer is limited to:

• cleaning the exterior weekly, or as needed

• cleaning the printer and results card slot every 3 months

• cleaning the air filter every 6 months

Biohazard: The interior of the analyzer should be considered contaminated after the first sample or control has been run.

5.1.1 Cleaning the exterior

Clean the outside surface of the analyzer at least every week and immediately after sample, reagent, or other material has been spilled on it. Clean the analyzer with a soft cloth dampened with a mild detergent or cleaning solution, or a 10% bleach solution (1 part bleach to 9 parts water), or a 30% isopropyl alcohol solution. Do not spray or pour detergents or other solution directly onto the analyzer. Wipe the entire surface of the analyzer, including the keypad. Observe Universal Precautions when cleaning spills.

5.1.2 Cleaning the printer

The printer should be cleaned at least once every 3 months to avoid paper jams and printer malfunctions. Dust, debris, hair, or objects may become deposited in the result card slot during the course of operation. If more than one attempt is required to feed a card into the slot, the printer may require cleaning.

Procedure: Expel a steady stream of compressed air directly into the results card slot, sweeping from right to left, pausing momentarily, then sweeping back to the right. It is important to direct a stream of air into the left side of the slot to clear any debris from the print sensor.

If the problem persists, a more thorough cleaning may be required. Access the printer follow the instructions for clearing a paper jam; then expel compressed air directly into the printer. For further assistance, call Abaxis Technical Support at 800-822-2947.

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5.1.3 Cleaning the air filter

The air filter should be cleaned at least once every 6 months. Check the air filter more frequently if the analyzer is in a dusty environment. To clean the air filter:

Step 1. Remove the filter.

Power down the analyzer and unplug the power cord from the back panel. Remove the back panel by removing the two Phillips screws at the top of the panel. Grasp the black mesh filter in the circular opening and pull the filter free.

Step 2. Wash the filter.

Use warm soapy water. Dry the filter thoroughly before replacing it in the analyzer.

Step 3. Replace the filter.

Tuck the sides in behind the edges of the circular opening. Replace the rear panel.

Step 4. Power up the analyzer.

Reconnect the analyzer to the power supply and plug it in. The analyzer returns to standby mode.

If the analyzer reports an error, repeat the installation procedure. If the error persists, call Abaxis Technical Support at 800-822-2947.

5-2 Maintenance and Troubleshooting

Piccolo Operator’s Manual

WER

OPEN

RECALL

EXIT

ENTER

5.2 Clearing a paper jam

If a results card becomes jammed in the printer, you can open the analyzer front panel and remove the card.

Step 1. Access the printer.

Open the disc drawer. Power down the analyzer and unplug the power cord from the back panel. Open the front panel by placing your thumbs at points A and B shown in the figure below. Grasp slot C on both sides of the front panel with your fingers and pull the panel toward you. (The panel is hinged at the bottom.) The printer is visible when the front panel is open.

P O

E C

N U

E X

L O

IT P E

T E

201 9009

Step 2. Remove the jammed card.

Lift the printer-head lever located on the right side of the printer, as shown in the figure above. Carefully remove the jammed result card. Push the printer-head lever back down to its normal position. Press the front panel firmly into the closed position.

Step 3. Power up the analyzer.

Reconnect the analyzer to the power supply and plug it in. The analyzer returns to standby mode.

Maintenance and Troubleshooting 5-3

Piccolo Operator’s Manual

5.3 Installing a software card

From time to time, Abaxis will provide software cards to update and add functionality to the analyzer. To install a software card:

Step 1. Remove the existing software card.

Power down the analyzer and unplug the power cord from the back panel. Remove the back panel by removing the two Phillips screws at the top of the panel. Remove the software card retaining bracket by removing the Phillips screw. Take care to avoid losing this very small screw. To eject the card, push the black button at the top of the access slot. Refer to the figures below.

Step 2. Insert the new software card.

Insert the new card with the printed label facing toward the center of the analyzer. Refer to the figure to the right. Push the card in firmly until it clicks into place. Replace the retaining bracket and back panel.

Step 3. Automatic reprogramming.

Power up the analyzer. It performs the self-test and reprogramming in about 10 minutes. Additional time may be required for the analyzer to reach operating temperature. The procedure is complete when the analyzer returns to standby mode.

If the analyzer reports an error, repeat the installation procedure, verifying that the new card is seated properly. If the error persists, call Abaxis Technical Support at 800-822-2947.

5-4 Maintenance and Troubleshooting

Piccolo Operator’s Manual

5.4 Reinitializing the analyzer

Reinitializing the analyzer may become necessary if the memory becomes corrupted. A Code 28 error message is a warning that the memory has become corrupted and must be reinitialized.

The reinitializing process clears all results from memory and deletes all customized reference ranges. After receiving a Code 28 message, check the status of the patient

and control results in memory following the procedures in 4.1 and 4.2. If results remain in memory, and the analyzer is linked to an external computer, follow the instructions to transmit all patient records, control records, and system QC data (see

4.4 and 4.5), respectively, to the external computer before reinitializing the software. If results remain in memory, and the analyzer is not linked to an external computer, print all records (patient, control, and system QC results) that you wish to retain, following the procedures in Section 4. Follow the procedure in 3.7 or 3.8 to print or transmit reference ranges.

Reinitializing restores all defaults. Refer to Section 3 for procedures for changing the date and time, selecting units, and customizing reference ranges.

Step 1. Access the Reset function.

From standby mode, press 0.

RESET Internal Clock CLEARING memory ENTER to accept

Step 2. Verify intention to reset.

Press

ENTER. The display reads:

Are you sure you want to reset? ENTER for yes EXIT for no

Step 3. Begin reinitialization.

Press

ENTER again. During the reinitialization process, the display reads:

Resetting clock ... Clearing Memory ...

5.5 Returning the analyzer to Abaxis for service

If the procedures in Maintenance and Troubleshooting fail to resolve a problem with the operation of the analyzer, call Abaxis Technical Support at 800-822-2947. Authorization from Technical Support is required before returning an analyzer for repairs.

Maintenance and Troubleshooting 5-5

Piccolo Operator’s Manual

5.6 Error messages

The following list of warnings and error messages is in order by error code number. Some error codes include an internal error code number displayed flush left on the 4th line of the display. Record this internal error code number before pressing calling Abaxis Technical Support at 800-822-2947. The number helps Technical Support to diagnose the problem. All error messages generate a cancellation report in addition to the error code. Insert a result card to print the report before pressing Have any error codes and the report, if applicable, at hand when calling Abaxis Technical Support.

EXIT or

EXIT.

Error Message Explanation and Solution

Code 10

Run canceled: Barcode error. Repeat run with new disc. xxxx See Code 10

Code 11

Ambient temperature outside operational range of analyzer. See Code 11

The disc bar code is unreadable because of scratches, spills, or other problems; or an outdated version of the software is installed on the analyzer.

Record the internal error code (xxxx). Press to acknowledge the message and open the drawer. Remove and discard the disc. Prepare a new disc using the sample or control and proceed with testing.

If this error message appears again during testing of the second disc, record the second internal error code. Insert a result card to print a troubleshooting report. When printing is complete, press

EXIT. Remove and discard the disc. Call

Abaxis Technical Support at 800-822-2947 with both internal error codes and the troubleshooting report at hand.

The ambient temperature is outside the analyzer operating range (15-32°C; 59-90°F).

Press

EXIT to acknowledge the message. Adjust

the room temperature, or power down the analyzer and move it to a warmer or cooler environment.

EXIT

5-6 Maintenance and Troubleshooting

Piccolo Operator’s Manual

Error Message Explanation and Solution

Code 12

Run canceled. Analyzer temperature outside operating range. See Code 12

Code 13

Run canceled. Disc out of date. Repeat run with new disc. See Code 13.

The analyzer temperature is too high or too low to run the disc.

Insert a result card to print the cancellation report. Press and open the drawer. Remove and discard the disc.

Temperature too low: If you are running the first disc after powering up, allow the analyzer more warm-up time. If the ambient temperature is below 15°C (59°F), adjust the room temperature or move the analyzer to a warmer environment. Use a new disc to run the sample or control.

Temperature too high: If the analyzer has run several discs, open the drawer and allow it to cool down for about 15 minutes. Use a new disc to run the sample or control.

The disc expiration date has passed.

Insert a result card to print the cancellation report. Press and open the drawer. Remove and discard the disc. Verify that the analyzer is using the correct date. Refer to 3.2. Use a within-date disc to run the sample or control.

EXIT to acknowledge the message

Maintenance and Troubleshooting 5-7

Piccolo Operator’s Manual

Error Message Explanation and Solution

Code 14

Run canceled. Repeat run with new disc.

xxxx See Code 14

Code 15

Run canceled. Insufficient sample. Repeat run with new disc. See Code 15

The problem may be with the sample, the disc, or the analyzer hardware or software.

Record the internal error code (xxxx). Insert a result card to print the cancellation report. Press

EXIT to acknowledge the message and open the

drawer. Remove and discard the disc. Use a new disc to run the sample or control. There may be a brief delay (10-15 seconds) before testing begins.

If this error message appears again during testing of the second disc, record the second internal error code. Insert a result card to print the cancellationreport. Press sage and open the drawer. Remove and discard the disc. Call Abaxis Technical Support at 800-822-2947 with both internal error codes and the troubleshooting report at hand.

The run has been canceled due to one of the following:

•Insufficient sample or control is in the disc.

•The whole blood sample has clotted.

•A used disc has been left in the analyzer.

Insert a result card to print the cancellation report. Press and open the drawer. Check the disc for insufficient or coagulated sample. Discard the disc. Use a new disc to run the sample or control.

EXIT to acknowledge the mes-

EXIT to acknowledge the message

5-8 Maintenance and Troubleshooting

Piccolo Operator’s Manual

Error Message Explanation and Solution

Code 21

Analyzer overheated. Refer to manual. See Code 21

Code 22

Faulty software card. Refer to manual for card replacement. xxxx See Code 22

This message may be displayed at the end of a run. The results of that run are not affected and may be reported. However, unless the analyzer is allowed to cool down, the next run may be aborted.

Insert a result card to print the cancellation report. Press and open the drawer. Remove and discard the disc. Leave the drawer open and allow the analyzer to cool down for about 15 minutes. If necessary, adjust the room temperature to 32°C (90°F) or less, or move the analyzer to a cooler environment.

This message may be displayed after powering up the analyzer. The software card may not be seated properly or may be faulty.

Record the internal error code (xxxx). Insert a result card to print the cancellation report. Press

EXIT to acknowledge the message. The analyzer

automatically shuts down. Refer to 5.3 for the procedure to reinstall the software card. If the problem persists, call Abaxis Technical Support at 800-822-2947.

EXIT to acknowledge the message

Code 24

Paper jammed in printer. Refer to manual to clear. See Code 24

Maintenance and Troubleshooting 5-9

Refer to 5.2 for instructions on clearing a paper jam.

Piccolo Operator’s Manual

Error Message Explanation and Solution

Code 25

Drawer malfunction. Refer to manual to clear. See Code 25

Code 26

Analyzer failure. Remove from service. xxxx See Code 26

The drawer motor has shut down because the drawer cannot completely close or open.

Drawer does not close: Press edge the message. Inspect the disc to see if the bar code ring has separated from the disc. If no separation is visible, reposition the disc and press close. If separation is visible, prepare a new disc and load it.

Drawer does not open: Call Abaxis Technical Support at 800-822-2947.

The analyzer has been exposed to very cold temperatures or there is a problem with the analyzer hardware that cannot be corrected by resetting the analyzer (powering down and up).Record the internal error code (xxxx). Press edge the message. Power down the analyzer and allow it to sit for 15-30 minutes at an ambient temperature of 15-32°C (59-90°F). Power up the analyzer and allow adequate warm-up time before running a disc.

If the analyzer has not been exposed to cold temperatures, there may be a hardware problem. Record the internal error code (xxxx). Press to acknowledge the message and shut down the analyzer. Call Abaxis Technical Support at 800-822-2947.

EXIT to acknowl-

EXIT

5-10 Maintenance and Troubleshooting

Error Message

Piccolo Operator’s Manual

Code 27

Run canceled. Disc rubbing. Repeat run with new disc. xxxx See Code 27

Code 28

Internal clock error corrected. Check analyzer time and date! See Code 28

Code 31

No results found in memory. Run a disc before printing. See Code 31.

The disc is not spinning properly or is rubbing against the walls of the drawer.

Record the internal error code (xxxx). Insert a result card to print the cancellation report. Press

EXIT to acknowledge the message and open the

drawer. Remove and discard the disc. Use a new disc to run the sample or control.

If this error appears again during testing of the second disc, record the second internal error code. Call Abaxis Technical Support at 800-822-2947 with both internal error codes at hand.

The memory may have become corrupted and may require reinitialization. Press acknowledge the message. Refer to 5.4.

This message appears only before the first use of the analyzer or if the memory was cleared when the analyzer was serviced.

Press

EXIT to acknowledge the message. Run a

sample or control before printing or recalling results.

EXIT to

Code 33

Reference ranges are corrupt. Ranges will be reset to factory values! See Code 33

Maintenance and Troubleshooting 5-11

There is a problem with the customized reference ranges stored in memory. All the ranges have been reset to the default value. Press acknowledge the message. Refer to 3.6 for directions on customizing reference ranges.

EXIT to

Piccolo Operator’s Manual

Error Message Explanation and Solution

Code 34

Memory error. All results and settings cleared from memory. See Code 34.

Code 35

Improper date set in analyzer. Correct date and repeat run. See Code 35

Code 36

Wrong disc type used (not Piccolo). Repeat run with new disc. See Code 36

A memory error has been automatically corrected. All patient and control results stored in the analyzer have been lost. Menu functions have been restored to their default settings. Results cannot be restored.

Press

EXIT to acknowledge the message. Refer to

Section 3 for instructions on resetting date, time and units, if necessary.

The internal clock is set to a date that is earlier than the manufacture date of the reagent disc.

Press

EXIT to acknowledge the message and open

the drawer. Remove and discard the disc. Refer to 3.2 for instructions on resetting the date. Use a new disc to run the sample or control.

The wrong disc type is being used (VetScan rotor in stead of Piccolo disc), or the analyzer has the wrong software installed.

Use a Piccolo disc and repeat the run. If the problem persists, call Abaxis Technical Support at 800-822-2947.

Code 37

Run canceled. Sample Quality Check Serum See Code 37

5-12 Maintenance and Troubleshooting

Unacceptably low transmission occurred at the wavelengths used to check for endogenous substances (HEM, LIP, ICT).

Insert a result card to print the cancellation report. If the sample distributed properly on the disc (beads dissolved), then the sample is likely hemolized (HEM). If the sample contains whole blood, separate the red blood cells out, and check whether the serum sample is hemolized (HEM), lipemic (LIP), or icteric (ICT).

Abbott 100-7008 Rev M Piccolo Operators Manual2 Pompe volumetirc Alaris VP Plus Guarrils Modele: 9003TIG03-G Mode d'emploi

Specifications and Main Features

Frequently Asked Questions

User Manual

Table of Contents

Section 1: Piccolo Features and Components

1.1 Intended use

1.2 Universal precautions

1.3 Near-patient testing efficiency

1.4 Overview of the procedure

1.5 External features

1.5.1 Display and keypad

1.5.2 Disc drawer

1.5.3 Result card slot

1.5.4 Power supply

1.5.5 Computer ports

1.5.6 Symbols used in labeling

1.5.7 Physical and environmental specifications

1.6 Internal components

1.6.1 Optics

1.6.2 Microprocessors and memory

1.6.3 Software

1.7 Piccolo reagent discs

1.7.1 Disc structure and function

1.7.2 Disc storage and handling

1.8 Result cards

1.9 Intelligent QC (iQC™)

1.9.1 Instrument iQC™

1.9.2 Reagent iQC™

1.9.3 Performance iQC™

1.10 Setup and power supply

1.10.1 Shipping verification

1.10.2 Powering up

1.10.3 Powering down

1.11 Connecting to an external computer

1.12 Bar Code Scanner Option/Requirements

1.12.1 Communication Interface

1.12.2 Communication Parameters

1.12.3 Barcode Formats

1.13 Consumables and ancillaries

1.14 Customer service and technical support

2.1 Sample requirements

2.2 Testing procedure

2.2.1 Preparing the reagent disc

2.2.2 Running a patient sample

2.2.3 Canceling an analysis in progress

2.3 Interpreting patient results

2.3.1 Reading the result card

2.3.2 Abnormal results: interpretation and further action

A. Results outside the dynamic range

C. Interferents

2.4 Running controls

2.5 Limitations of the procedure

Section 3: The Menu Functions

3.1 Accessing a particular special function

3.2 Viewing analyzer identification

3.3 Changing the date and time

3.4 Selecting the date format

3.5 Selecting the time format

3.6 Customizing reference ranges

3.7 Printing reference ranges

3.8 Transmitting reference ranges

3.9 Selecting a language

3.10 Selecting units

3.11 Selecting the data format

Section 4: The Recall Function

4.1 Viewing or printing patient records

4.2 Viewing or printing control records

4.3 Viewing or printing error records

4.4 Transmitting patient records

4.5 Transmitting control records

4.6 Transmitting error records

Section 5: Maintenance and Troubleshooting

5.1 Routine maintenance

5.1.1 Cleaning the exterior

5.1.2 Cleaning the printer

5.1.3 Cleaning the air filter

5.2 Clearing a paper jam

5.3 Installing a software card

5.4 Reinitializing the analyzer