Abaxis Piccolo User manual

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Page 1

Operator’s Manual

Page 2

Piccolo® Point-of-Care Che mi stry An al yze r

Operator’s Manual

For in vitro diagnostic use

Abaxis, Inc. 3240 Whipp le Road Union City, California, USA 94587

800-827-2947 Customer Service and Technical Support

PN 100-7008 Rev. G

March 13, 2001

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Piccolo Operator’s Manual

Table of Contents

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

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

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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 . . . . . . . . . . . . . . . . . . . . . . . . . . .2-10

Section 3: The Menu Function

3.1 Run controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-1

3.2 Change the date and time . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-2

3.3 Select date format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-4

3.4 Select time format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-4

3.5 Select Units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-5

3.6 Customize reference ranges . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-6

3.7 Print reference ranges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-8

3.8 Transmit reference ranges . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-9

3.9 View analyzer identification . . . . . . . . . . . . . . . . . . . . . . . . . . .3-10

Section 4: The Recall Function

4.1 Scanning patient results in chronological order . . . . . . . . . . .4-1

4.2 Recalling results by specifying patient ID . . . . . . . . . . . . . . . .4-3

4.3 Scanning control results in chronological order . . . . . . . . . . .4-5

4.4 Recalling a specific control result . . . . . . . . . . . . . . . . . . . . . . .4-6

4.5 Scanning system QC data associated with patient results

in chronological order . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-8

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4.6 Recalling System QC data associated with patient results

by specifying patient ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-10

4.7 Scanning system QC data associated with control results in chronological order 4-12

4.8 Recalling system QC data associated with

a specific control result . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-13

4.9 Transmitting results to an external computer . . . . . . . . . . . . .4-16

4.10 Transmitting system QC to an external computer . . . . . . . . .4-17

4.11 No results in memory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-18

4.12 No system QC in memory . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-18

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

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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. Test systems must produce reliable results when used by operators with a wide range of skill levels. An important criterion is ease of use, and automated systems with minimal handling and processing steps, like the Piccolo® Point-of-Care Chemistry Analyzer, are easy to operate and are widely used in near-patient environments.

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 . External and internal features of the analyzer are described and illustrated below.

The operator begins the Piccolo procedure by introducing whole blood, plasma, or serum sample into a self-contained reagent disc and loading the d isc into the analyzer. No premeasuring or sample preparation steps are required. The operator then enters patient, operator, and physician

numbers using

the keypad and display screen. The analyzer performs the remainder of the testing protocol auto-

HEM

GLOB

LIP

ICT

K+

GLU

CRE

-5

CHOL

-8

CA++ LIP

-5

G/DL

BUN

-1

G/DL

TBIL HEM

MM0l/L

AMY

MG/DL

-1

MG/DL

♦

-2

♦

ALP

♦

MG/DL

ALB

-0

MG/DL

LIP

-1

MG/DL

SERIAL#

-1

MG/DL

OPER

U/L

DISC

-4

GENERAL

U/L

LOT #:

U/L

TIENT

G/DL

PATIENT

CHEMISTRY

DR #:

TYPE:

-2

MALE

Piccolo Features and Components 1-1

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Piccolo Operator’s Manual

matically in about 12 minutes. The used reagent disc is removed and the analyzer is ready for the next sample.

The chemical reaction s carried o ut by this an alyzer a re designed t o pr oduce 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 testing at the point of care. Its small footprint allows convenient placement of the analyzer in a near-

Display

Keypad

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 has DC power supply and 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 m essages. It also reflects info rmation input via the keyboard so it can be verified or corrected.

The operator inputs data through the 10 numeric

POWER

OPEN

789

keys, 6 function keys, and 2 arrow keys. Refer to th efigure at the right for the keyboard layout. The specific uses of these keys are described in

Sections 2, 3

and 4. The

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

POWER

OPEN/CLOSE

key is used to power the analyzer up or

2.2.3

key operates the sliding drawer

where the reagent disc sits. This key is referred to in the text as either the

OPEN

key as appropr i ate in context. Closing a drawer

containing a reagent disc initiates an analysis. Two of the function keys,

RECALL

, provide access to special functions described in detail in

Sections 3

RECALL

and

and 4.

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

OPEN/CLOSE

1-2 Piccolo Features and Components

key to change the posi-

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Piccolo Operator’s Manual

tion of the drawer.

instrument.

Do not push on the drawer to close it. This may damage the

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 DC power, providing portability in point-of-care testing environments.

Recessed handle

AC Power supply cord

Two power supply components are included. A

DC adapter

plugs into the socket on the lower left back of the analyzer, allowing the use of a 12-volt battery as the power source. An

AC power cord

connects the power adaptor to a grounded electrical outlet.

RS232

computer

ports

Power adaptor

DC Power supply cord

1.5.5 Computer ports

Two RS232 ports support 2-way communication between the analyzer and external devices. Only port 1 [labeled RS232(1)] should be used at this time. Port 2 is reserved for future use. Refer to computer.

1.11

for information on linking the analyz er to a n externa l

1.5.6 Symbols used in labeling

The following symb ols 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

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Piccolo Operator’s Manual

1.5.7 Physical and environmental specifications

Height: 24.2 cm 9.5 inches Wi dth: 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-co ndensing Reaction temperature: 37°C 98.6°F

Power requirements: 250–90 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 anal yte co ncentrat ions, two mi cr opr oce ssor s to contr o l test ing an d analyt ical 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 instrumen t, and consequently of the results and the integrity of the data.

The analyzer stores 150 patient results, 75 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

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Piccolo Operator’s Manual

1.6.3 Software

The analyzer software comprises two matched programs. One program controls the measurement engine itself, ie, it schedules the flashing of the light source and collects the light intensity data for different cuvettes at different times during the rea ction; 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

Software upgrades are distributed to registered users on a PCMCA card and installed on site. Refer to

5.3

for instructions on installing a softwa re card.

, patient results, and control data).

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 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.

bar code ring

The cific for the chemistries in the disc. It also contains the disc identification code, lot number, and expiration date. The analyzer automat ica lly checks the code and rejects an expired disc. The bar code ring also protects the optical surfaces of the cuvette fr om fingerprints and ot her debris, and helps minimize conta mination of the analyzer by capturing small drops of blood that may be on the disc surface.

sample port,

The surface of the disc, provides access to the has been loaded into the sample chamber, the arrows molded on the disc surface.

cuvettes

are located around

Bar Code Ring

Cuvettes

Sample Port

Diluent Container

Sample Fill Line

attached to the top of the reagent disc contains calibration data spe-

demarcated by an arrow pointing to a circle molded onto the upper

sample chamber

sample fill line

. When sufficient sample

forms between two

Piccolo Features and Components 1-5

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Piccolo Operator’s Manual

A sample

diluent

is sealed in a container inside the center of the disc. At the begin-

ning 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 measur ed q uantities of sam ple 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 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 no t expose discs, in or out of the foil pouches, to direct sunlight or to tempera-

tures 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 adversely affect 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

Write Patient ID

Here

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.

1-6 Piccolo Features and Components

Page 13

Piccolo Operator’s Manual

04/05/96

1:35

PATIENT

TYPE: MALE

PATIENT

103195-2-1

GENERAL CHEMISTRY

DISC LOT #:

6054 A

OPER #:

000 DR #: 000

SERIAL #: 000000827

ALB 3.3 2.5-4.4 G/DL ALP L I P

20-150 U/L

ALT

<10

10-118

U/L

AMY

♦♦♦ 200-1200 U/L

TBIL HEM

0.1-0.6

MG/DL

BUN

>180

7-25

MG/DL

CA++ LIP

8.6-11.8

MG/DL

CHOL

24 4 125-270

MG/DL

CRE I C T

0.3-1.3

MG/DL

GLU

112* 60-110

MG/DL

K+

4. 5 3.7-5.8

MM0l/L

6. 3 5.4-8.2 G/DL

GLOB

3. 0 2.3-5.2 G/DL

QC OK HEM

3+ , LIP 3+ , ICT 1+

PICCOLO

1.8 Result cards

Result cards are durable paper strips, about 6 inches long by 2.5 inches wide, designed for use with the Piccolo

Point-of-Care 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

cards, QC report cards, and troubleshooting reports. Refer to

and

Section 4

for information about printing result

1.12

for ordering information. The result card has an adhesive backing so it can be placed into the

patient’s file. The operator should follo w the institution’s procedures for disposition of the result card.

1.9 Intelligent QC (iQC™)

The Piccolo® Point-of-Care Chemistry Analyzer includes design an d user interf ace features that perform compr ehensive sy stem-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 accu rate and reliable results. Two types of QC reagent beads (instrument and chemistry) are included in each disc. Refer to 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.

1.7.1

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 inst ructions.

iQC™ greatly reduces the requirement for routine control testing. Refer to ommendations and procedure for control testing. Operators requiring assistance setting up control testing procedures should contact Abaxis Technical Support.

Piccolo Features and Components 1-7

2.4

for rec-

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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 a na lysis.

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 differen t 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 th e 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 tha t 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

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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

• 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 custom er 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 instru ment and void the warranty.

Point-of-Care Chemistry Analyzer

Operator's Manual

• Connect the analyzer only to a

• To pr event 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 uninterruptible power supply (UPS).

• 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 ana lyzer 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

sage will appear on the display. The self-test is described in check all power supply connections.

electrical outlet. The self-test mes-

1.9.1

. If the display is blank,

grounded

electrical outlet.

Performing self-test

Piccolo Features and Components 1-9

Page 16

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, ie, 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 ar e corr ect. Ref er to date and time.

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

Refer to

1.11

Step 5. Perform control testing.

Per form one or more runs using recommended controls before running patient samples to confirm that the analyzer is functioning to specification. Refer to run procedures.

3.2

to change the

2.4

for control

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

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

POWER

drawer. This message appears when the

shutdown procedure and return the analyzer to standby mode.

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

Press

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

POWER

tem shutdown is complete.

Performing system shutdown.

key rather than by unplugging the analyzer.

POWER

key is pressed. Press

POWER

to cancel the system

EXIT

1-10 Piccolo Features and Components

Page 17

Piccolo Operator’s Manual

1.11 Connecting to an external computer

An institution may wish 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 sys tems. The instrument provides two RS232 ports for connection to external devices. Data from the analyzer are exported to the external computer as text files (*.txt). Contact Abaxis for technical support.

1.12 Consumables and ancillaries

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

1.13 Customer service and technical support

Call Abaxis Customer Service and Technical Support at 800-822-2947 with questions

regarding operation of and problems with the Piccolo Analyzer.

Point-of-Care Chemistry

Piccolo Features and Components 1-11

Page 18

Page 19

Piccolo Operator’s Manual

Section 2: Testing Procedure and

Interpretation of Results

2.1 Sample requirements

• The Piccolo® Point-of-Care Chemistry Analyzer accepts heparinized whole blood,

heparinized pla s ma, or serum samples.

• Lithium heparin is the only anticoagulant recommended for use with the Piccolo

Point-of-Care Chemistry Analyzer.

• A sample size of 90–120µL is required.

• Whole blo od 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 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 analy te concentrations.

• For accurate interpretation of glucose results, the sample should be collected f rom

a patient who has fasted for at least 12 hours.

• Operator health and safety require that Universal Precautions be observed at all

times while handling hum an 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 befor e beginning the procedure. Th e power-up

procedure is described in

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

The analyzer is in standby mode, ie, ready to run a disc, when the display reads

•

Open drawer to run a disc

1.10.2

Testing Procedure and Interpretation of Results 2-1

Page 20

Piccolo Operator’s Manual

Write Patient ID

Here

90 µL

> 90 µL < 120 µL

<90 µL

> 120 µL

2.2.1 Preparing the reagent disc

• Refer to dling instructions. Please become thoroughly familiar with this information before beginning the procedure.

1.7

for complete information about Piccolo ® reagent discs, in clud ing han-

• 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 or other transfer device to dispense approximately 100 µL of sample into the disc via the sample port.

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 surface. Push down on the plunger with a slow, continuous motion. Take care not to overfill the sample chamber. A 90 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 overfill the chamber. Discard the pipette tip into a biohazard 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-fr ee tis sue 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. (Optional) Label the disc.

Write the patient

on the disc surface in the space indicated in the figure above.

Do not write anywhere else on the disc or on the bar code ring.

d. Carry the prepared disc to the analyzer.

Hold the disc by its edges in a flat position.

2-2 Testing Procedure and Interpretation of Results

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Piccolo Operator’s Manual

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

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

s 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 displa yed at any time during the run, refer to

5.6

for trouble-

shooting procedures associated with the specific error code.

Step 2. Open the drawer and insert the disc .

Press

. The following messages are displayed sequen-

OPEN

tially:

Opening drawer...

Close drawer to start analysis.

s while

Place the disc in the drawer. Press

Closing drawer...

. 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 enter when the

correct number appears to the right of

Select Set:_ X 1- Male 2- Female 3- Special ENTER to accept.

Select Set

Testing Procedure and Interpretation of Results 2-3

Page 22

Piccolo Operator’s Manual

Step 4. Enter the patient

A patient

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

Input Patient #: _ _ _ _ _ _ _ _ ENTER when finished.

Step 5. Enter the operator

By default, the operator

for the previous sample is displayed. Enter the operator ID

for the current sample, up to 3 characters. Press

Input Operator #: XXX ENTER when finished.

Step 6. Enter the physician

By default, the physician

for the current sample, up to 3 characters. Press

Input DR #: XXX ENTER when finished.

for the previous sample is displayed. Enter the physician

ENTER

Step 7. Automatic sample processing.

The analyzer processes the sample and calculates results in less tha n 15 minutes with no further operator input. During the run, the analyzer displays the following mes-

sage, including time remaining to complete the analysis (

Results ready in XX:XX for patient #: XXXXXXXXXXXXXX

XX:XX

) and patient ID.

Sample processing is complete when the analyzer beeps and disp lays the message:

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

Step 8. Print results.

To end the procedure without printing results, press If a Run Cancelled error message is displayed, refer to

ther instructions.

and continue to step 9.

OPEN

5.6

for an exp l anation and fur-

2-4 Testing Procedure and Interpretation of Results

Page 23

Piccolo Operator’s Manual

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...

Remove disc and close drawer.

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

to return the analyzer to standby mode.

2.2.3 Canceling an analysis in progress

Press the analysis should be canceled:

Press

to cancel an analysis in progress. The display requests verification that

POWER

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

again to cancel the analysis. These messages appear sequentially:

POWER

Analysis canceled.

Opening drawer...

Testing Procedure and Interpretation of Results 2-5

Page 24

Piccolo Operator’s Manual

Remove disc and close drawer.

Remove the reagent disc from the drawer. Press

to retu r n the analyzer to

standby mode. For the run cancellation to take effect, the operator must press

before the ana-

POWER

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 st ep 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 tr ansmitted. 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 mation about the result card. Follow your lab or institution’s procedure for transferring the card to the patient’s chart.

2.3.1 Reading the result card

result card heading

The

• test date and time

• reference range set

• pat ient, operator, and physician

• reagent disc type and lot number

• analyzer serial number.

test results section

The

• analyte

• ana lyte concentration

• reference range in specified units. An asterisk (*) printed to the right of the analyte concentration in dica tes

side the reference range

includes:

s; or control level

of the card is printed in three columns:

1.8

for basic infor-

results out-

A greater than (>) or less than (<) symbol printed to the left of the value in the analyte concentration column indicates Refer to

A row of diamonds (

pressed results

2.3.2 A.

, below.

♦♦♦

. Refer to

) printed in place of analyte concentration indicates

2.3.2 B.

results outside the dynamic range

below.

of the assay.

sup-

2-6 Testing Procedure and Interpretation of Results

Page 25

Piccolo Operator’s Manual

HEM, LIP

affected by by hemolysis and either or both of the other interferents, result is affected by both lipemia and icterus, indices printed at the bottom of the card to determine if more than one interferent is

affecting results. Refer to

INST QC: OK and CHEM QC: OK

when iQC testing indicates that all ins trume nt, d isc, and chemistry parameters meet specifications.

Sample indices for hemolysis, lipemia, and icterus

card. The sample is rated for these interferents on the following scale:

clear

slight

moderate

gross

ICT

, or

interference from hemolysis, lipemia, or icterus

is printed in place of the analyte concentration when results are

LIP

is printed. Examine the sample

2.3.2 C.

below for further instructions.

printed near the bottom of the result card

are printed at the bottom of the

. When a result is affected

HEM

is printed. When a

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 cose above this range wou ld be printed as

<10 mG/DL

>700 mG/DL

; a sample concentration of glu-

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

B. Suppressed results

A result may be suppressed (ie, not held in memory and not able to be printed) when any of the internal QC steps detect an abnormal condition.

Collect a new sample and rerun the test . If results f or the second sample are suppressed, call Abaxis Technical Support for further assistance.

(

♦♦♦

)

C. Interferents

The limits for physical interferents are given in the Piccolo reagent disc package insert.

Testing Procedure and Interpretation of Results 2-7

Page 26

Piccolo Operator’s Manual

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 th e degree of hemolysis can be verified. If the new sample is hemolytic, use an alternati ve 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 sam-

ples. 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 the sample to a reference labora tory.

2.4 Running controls

Abaxis recommends control testing as follows:

• at least every 30 days

• whe never laboratory conditions have changed significantly

• when training or retraining of personnel is ind i c ated

• when test results do not match patient symptoms or clinical findings Good laboratory practices include the recording of the QC data according to the labo-

ratory’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

RECALL

key. Control results are automati-

cally transmitted to a linked computer. Handle the control as described in the control package insert. Call Abaxis Technical

support for assistance in interpreting control results.

Step 1. Prepare the reagent disc.

Use a micropipette 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. Activate the Run Controls function.

Press

one time. Press

Press ENTER to run controls, MENU for next option EXIT to leave.

ENTER

2-8 Testing Procedure and Interpretation of Results

Page 27

Piccolo Operator’s Manual

Step 3. 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

Select level: xxx 1- I3-III 2- II ENTER to accept.

ENTER

Step 4. Enter the operator

By default, the display shows the operator operator

for the current control run, up to 3 characters. Press

Input Operator #: XXX ENTER when finished.

Step 5. Enter the physician

By default, the display shows the ph ysician physician

for the current run, up to 3 characters. Press

Input DR #: XXX ENTER when finished.

for the previous control run. Enter the

ENTER

for the previous control run. Enter the

ENTER

Step 6. Insert the prepared disc.

Following step 5, the drawer opens and the following messages are displayed sequentially:

Opening drawer...

Close drawer to start analysis. Control Level xxx

Insert the disc. Press close. This message appears briefly:

Closing drawer

Testing Procedure and Interpretation of Results 2-9

Page 28

Piccolo Operator’s Manual

Step 7. Automatic control processing.

The analyzer displays the control level and time remaining to compl e te the analysis.

Results ready in XX:XX for control: Level XXX

When the analysis is complete, the analyz er beeps and displays the message:

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

Step 8. Print control results.

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

and continue with step 9.

OPEN

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

. 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 t he result card as

HEM

. Refer to

2.3.2 C.

• The ana lyzer suppresses results when the precision is signif icantly affected by

hemolysis, lipemia, or icterus. Refer to

2.3.2 C.

for instructions.

2-10 Testing Procedure and Interpretation of Results

Page 29

Piccolo Operator’s Manual

Section 3: The Menu Function

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

twice to return to standby mode.

EXIT

key. You can access the Menu function from

to return to the previous display. Press

EXIT

Function

Run controls Run controls 1 time Change date and time Set the date and time 2 times Select date format Choose month/day/year or

day/month/year Select time format Choose 12-hour or 24-hour clock 4 times Select units Choose international units ( SI) or units

commonly used in the United States Customize reference

ranges

Print reference ranges Print the reference ranges in a specified

Transmit reference ranges

Vi ew analyz er

Escape from function

Change ref erence ranges from defaults

to ranges specific to the patient popula-

tion

reference range set

Transmit all the reference ranges stored

in memory to a linked computer

Vi ew the analyzer serial number and

software version

EXIT

Description

Press

3 times

5 times

6 times

7 times

8 times

9 times

Refer to

2.4

3.2

3.3

3.4

3.5

3.6

3.7

3.8

3.9

3.1 Run controls

Refer to stores control results in memory separate from the sample results, so you can use the Recall function to search specifically for control results. In all other respects, controls and samples are run identically by the analyzer.

The Menu Function 3-1

2.4

for the complete procedu re for running controls. This Menu function

Page 30

Piccolo Operator’s Manual

3.2 Change the date and time

The date and time are checked during the set up procedure. Refer to

1.10

. Change the

date or time format, if necessary, before changing the actual date or time. Refer to

3.4

and

Step 1. Press

twice to reach the Change Date and Time function:

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

Step 2. Display the date or time in the active format.

Press

. Use the numeric keys 1 or 2 to choose date or time. Press

ENTER

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

ENTER

Step 3. Change the date.

← →

Use

and the numeric keys to enter the correct date. Press

to return to the

ENTER

screen in step 2.

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

to move cursor,

← →

ENTER to accept.

3.3

Step 4. Change the time.

← →

Use

If the 12-hour clock option is active, use or

and the numeric keys to enter the correct time. Press

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

to move cursor,

← →

ENTER to accept.

← →

and the numeric keys 1 or 2 to select

. Press

. (If the 24-hour clock is active, this option will not appear on the

ENTER

screen.)

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

to move cursor,

← →

ENTER to accept.

3-2 The Menu Function

Page 31

Piccolo Operator’s Manual

If an invalid date (eg, 14 for the month) or time (eg, 30 for hours) has been entered, an invalid entry message appears:

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

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

Press

to return to the screen shown in Step 3. or Step 4 ., wher e you can corr ect the

EXIT

date or time.

Step 5. Verify date and time settings.

When the date or time you entered is valid, the following scr een is displayed. To make more changes, press either 1 or 2 and

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

. Repeat Step 3. or Step 4.

ENTER

Step 6. Return to standby mode.

EXIT

twice.

Press

The Menu Function 3-3

Page 32

Piccolo Operator’s Manual

3.3 Select date format

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

Step 1. Press

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

3 times to reach the Select Date Format function:

Step 2. Choose the date format.

Press

to display the active date format. To select the alternative format, press 1

ENTER

or 2 . The format you chose will be displayed. Press

Select:1 MM/DD/YY 1- MM/DD/YY 07/16/95 2- DD/MM/YY 16/07/95 ENTER to accept.

Step 3. Return to standby mode.

EXIT

Press

3.4 Select time format

Options are a 12-hour clock and a 24-hour clock.

Step 1. Press

4 times to reach the Select Time Format function:

ENTER

to accept.

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

Step 2. Choose the time format.

Press or 2. The format you chose will be displayed. Press

to display the active time format. To select the alternative format, press 1

ENTER

to accept.

ENTER

Select: xx hour 1- 12 hour 02:25 PM 2- 24 hour 14:25 ENTER to accept

Step 3. Return to standby mode.

Press

EXIT

twice

3-4 The Menu Function

Page 33

Piccolo Operator’s Manual

3.5 Select units

Options are common (eg, mg/dL) or SI (eg, mmol/L) units for reporting results.

Step 1. Press

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

5 times to reach the Select Units function.

Step 2. Accept or change the active option.

Press alternative option. Press

. The display indicates which option is active. Press

ENTER

Common Units

to change

← →

ENTER to accept.

SI (Int’l) units

to change

← →

ENTER to accept.

Step 3. Return to standby mode.

Press

EXIT

← →

to select the

The Menu Function 3-5

Page 34

Piccolo Operator’s Manual

3.6 Customize reference ranges

Change the default or existing reference ranges stor ed in the an alyzer to match the re ference ranges specific to the patient population.

NOTE: Change reference ranges in either c ommon units or SI units, not both. The analyz er automatically converts units.

Step 1. Press

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

6 times to reach the Change Reference Ranges function:

Step 2. Select the method (analyte).

Press

ENTER

. Use

← →

to choose a method (analyte) other than the one shown on the

display.

Select Method: xxxxxxxxxxxxx

Press ENTER to accept.

← →

to scan,

Step 3. Select the reference range set.

Use the numeric keys. Press

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

ENTER

The method (analyte) and its current reference range set and values are displayed.

Method Gender Range Units 0-9 keys to change,ENTER to accept.

Step 4. Change the reference range set or values.

← →

Use

and the numeric keys. Press

to accept the changes. The analyzer

ENTER

returns to the screen displayed in Step 2.

Select Method: xxxxxxxxxxxxx

← →

to scan,

Press ENTER to accept.

3-6 The Menu Function

Page 35

Piccolo Operator’s Manual

Step 5. Correct errors.

If an invalid value has been entered, the following screen is displayed. Press current reference range values will be restored. Repeat step 4 with valid data.

Reference range entry not valid. Press EXIT.

Step 6. Change the reference ranges for other methods (analytes).

Repeat steps 2-4.

Step 7. Print reference ranges.

Ve rify reference ranges by printing them on a result card. From the screen in Step 4., press

EXIT, MENU

to bring up the Print Reference Ranges menu option. (Refer to

The date and tim e shown on the card are the date and time the card was printed, not the date and time the refer enc e ranges wer e chan ged. To record the date you changed th e ranges, write it on the card.

Step 8. Return to standby mode.

Press

EXIT

twice.

EXIT

. The

3.7

The Menu Function 3-7

Page 36

Piccolo Operator’s Manual

3.7 Print reference ranges

Print the reference ranges for a specific reference range set.

The date and time shown on the card are the date and time the card was printed, not the date and time the reference ranges were changed. To record the date you changed the ranges, write the information on the card.

Step 1. Press

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

7 times to reach the Print Reference Ranges function:

Step 2. Select the reference range set to be printed.

Press

. Use the numeric keys. Press

ENTER

Select Set : ZZZZZ 1- Male 2- Female 3- Special ENTER to accept.

ENTER

again

Step 3. Print.

Verify that the reference range set of interest is displayed. Inser t a result card. Follow the instructions on the display:

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

Printing ranges. Remove card

Step 4. Print additional reference ranges.

After the card is removed, the display returns to the screen in step 2. Repeat steps 2 and 3.

Step 5. Return to standby mode.

Press

EXIT

twice.

3-8 The Menu Function

Page 37

Piccolo Operator’s Manual

3.8 Transmit reference ranges

The reference ranges stored in the analyzer memory can be transmitted to a linked computer.

reference ranges were changed.

computer.

The date and time recorded are those of the transmission, not the date and time the

Refer to

1.11

for instructions for linking to an external

Step 1. Press

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

8 times to reach the Transmit Reference Ranges function:

Step 2. Select the reference range set to transmit.

Press

. Use the numeric keys. Press

ENTER

Select Set: ZZZZZ 1- Male 2- Female 3- Special ENTER to accept.

ENTER

again

During the transmission , th e display reads:

Transmitting ranges to computer.

Step 3. Transmit additonal reference ranges

After transmission is complete, the display returns to the first screen in step 2. Repeat step 2.

Step 4. Return to standby mode.

Press

EXIT

twice.

The Menu Function 3-9

Page 38

Piccolo Operator’s Manual

3.9 View analyzer identification

Step 1. Press

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

9 times to reach the View Analyzer ID function:

Step 2. Display the serial number and software version.

Press

ENTER

Serial #:xxxxxxxxxxSoftware version:X.XXXPress ENTER.

Step 3. Return to standby mode.

Press

EXIT

twice.

3-10 The Menu Function

Page 39

Section 4: The Recall Function

Piccolo Operator’s Manual

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 150 patient samples and the last 75 control samples, in reverse chronological order. (Refer

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 scanning the entries in chronological order.

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

The Recall function can be accessed whenever the analyzer is in standby mode. It cannot be accessed from the Menu functions. Press

at any time while in the Recall

EXIT

function to return to the previous display.

• Use the numeric and arrow keys to enter patient, operator, and physician

The → key functions as a dash; the ← key functions as a backspace (delete key).

•The message

No results in memory

may be displayed after the analyzer

memory has been cleared during servicing. If it is displayed at any other time, refer to code number is displayed, refer to

5.6

for troubleshooting procedur es under the error code number. If no err or

4.11

4.12

4.1 Scanning patient results in chronological order

Step 1. Access the Recall function.

From standby mode, press

RECALL

. The display reads:

Recall: 1 Results 1-Results 2-System QC ENTER to accept.

Step 2. Access Results.

Press 1,

. The display reads:

ENTER

Recall: 1 Patient 1-Patient Results 2-Control Results ENTER to accept.

The Recall Function 4-1

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Piccolo Operator’s Manual

Step 3. Choose the results set of interest.

Press 1,

Step 4. Accept the print option.

Press 1, played.

Step 5. Scan patient results.

← →

Use nological order. The analyzer beeps twice when you have reached either end of the list. To exit without printing results, press

for patient results. The display reads:

ENTER

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

. By default, the patient ID, date, and time of the most recent run are dis-

ENTER

Pt # XXXXXXXXXXXX xx/xx/xx xx:xx

to view results,

← →

ENTER to print.

to view the results in sequence. Patient results are retrieved in reverse chro-

three times to return to standby mode.

EXIT

Step 6. Print patient results.

When the result of interest is displayed, press

. (Data are automatically transmit-

ENTER

ted to a linked computer.)#The following messages are displayed sequentially:

Insert card to print results.

Printing results...

Remove card.

Step 7. Scan more patient results.

When the card is removed, the display returns to the screen in step 4. Repeat steps 5 and 6.

Step 8. Return to standby mode.

Press

three times.

EXIT

4-2 The Recall Function

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Piccolo Operator’s Manual

4.2 Recalling results by specifying patient ID

Step 1. Access the Recall function.

From standby mode, press

Recall: 1 Results 1-Results 2-System QC ENTER to accept.

RECALL

Step 2. Access Results.

Press 1,

. The display reads:

ENTER

Recall: 1 Patient 1-Patient Results 2-Control Results ENTER to accept.

Step 3. Choose the results set of interest.

Press 1 and

for patient results. The display reads:

ENTER

. The display reads:

Select: 1 Print Print result card Transmit result ENTER to accept

Step 4. Accept the Print option.

Press 1,

. By default, the patient ID, date, and time of the most recent run are dis-

ENTER

played.

Pt # XXXXXXXXXXXX xx/xx/xx xx:xx

to view results,

← →

ENTER to print.

Step 5. Specify the patient

Press

RECALL

. Key in the patient ID. Press

memory for the specified patient

Search for patient # XXXXXXXXXXXXXX

ENTER to search.

. The analyzer retrieves all results in

ENTER

The Recall Function 4-3

Page 42

Piccolo Operator’s Manual

a. If no

Press step 5 using a different patient ID; or press

b. If

The total number of matches (runs) found for the specified patient by ical order . For example, “ and the most recent of these is selected. Use patient

matches

ENTER

one or more matches

ttt

. Individual matches, represented by

. To exit without printing results for any run in this set, press

are found for the specified patient

Pt # XXXXXXXXXXXXXX not found Press ENTER.

, the display reads:

to return to the screen in step 4. V erify that the patient ID is corre ct. Repeat

three times to return to standby mode.

EXIT

are found, the display reads:

Pt # XXXXXXXXXXXX xx/xx/xx xx:xx

nnn of ttt, ENTER to print.

to view

← →

1 of 3

nnn,

are numbered in reverse chronolog-

” means three matches were found for this patient

← →

to scan other matches for this

is represented

EXIT

to the screen in step 4. Repeat step 5 using a different patient ID; or press times to return to standby mode.

to return

three

EXIT

Step 6. Print patient results.

When the result of interest is displayed, press

. (The data are automatically

ENTER

transmitted to a linked computer.)#The following messages are displayed sequentially:

Insert card to print results.

Printing results...

Remove card.

Step 7. Retrieve results for a different patient

When the card is removed, the display returns to the screen in step 4. Repeat steps 5–6.

4-4 The Recall Function

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Piccolo Operator’s Manual

Step 8. Return to standby mode.

Press

three times.

EXIT

4.3 Scanning control results in chronological order

Step 1. Access the Recall function.

From standby mode, press

Recall: 1 Results 1-Results 2-System QC ENTER to accept.

Step 2. Access Results.

Press 1,

ENTER

Recall: 1 Patient 1-Patient Results 2-Control Results ENTER to accept.

RECALL

. The display reads:

Step 3. Choose the results set of interest.

Press 2,

for control results. The display reads:

ENTER

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

Step 4. Accept the Print option.

Press 1,

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

ENTER

run are displayed.

Control level: XXX xx/xx/xx xx:xx

to view results,

←,→

ENTER to print.

Step 5. Scan control results.

← →

Use

to view the results of other con trol runs. Control run data are retrieved in

← → ← →

reverse chronological order. The analyzer beeps twice when you have reached either end of the list. To exit without printing control r esults, press

three times to return

EXIT

to standby mode.

The Recall Function 4-5

Page 44

Piccolo Operator’s Manual

Step 6. Print control results.

When the control run of interest is displayed, pr ess sages are displayed sequentially:

Insert card to print results.

Printing results...

Remove card.

Step 7. Scan more control results.

When the card is removed, the analyzer r eturns to the dis play in step 4. Repeat steps 5 and 6.

to print. The following mes-

ENTER

Step 8. Return to standby mode.

Press

three times.

EXIT

4.4 Recalling a specific control result

Step 1. Access the Recall function.

From standby mode, press

Recall: 1 Results 1-Results 2-System QC ENTER to accept.

Step 2. Access Results.

Press 1,

. The display reads:

ENTER

Recall: 1 Patient 1-Patient Results 2-Control Results ENTER to accept.

RECALL

. The display reads:

4-6 The Recall Function

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Piccolo Operator’s Manual

Step 3. Choose the results set of interest.

Press 2,

Step 4. Accept the Print option.

Press

ENTER

are displayed.

Step 5. Specify the control run.

Press

RECALL

retrieves all control results in memory for the specified date.

for control results. The display reads:

ENTER

Select: 1 Print Print result card Transmit result ENTER to accept

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

Control level:XXX xx/xx/xx xx:xx

to view results,

←,→

ENTER to print.

. Key in the date of the control run of interest. Press

. The analyze r

ENTER

Search for control results on xx/xx/xx ENTER to print.

no matches

a. If

Press

ENTER

in another date or use

are found for the specified date, the display reads:

No control results found on xx/xx/xx Press ENTER.

to return to the screen in step 4. V erify that the date entered is correct. Key

← →

return to standby mode.

one or more matches

b. If

Control Level: XXX xx/xx/xx xx:xx

nnn of ttt,← ENTER to print.

to scan other control results; or press

are found, the display reads:

to view

→

three times to

EXIT

The Recall Function 4-7

Page 46

Piccolo Operator’s Manual

In the mes sage above, specified date. Individual matches are represented by

ttt

represents the total number of control runs found for the

nnn

. For example, “

1 of 3

means data on three control runs were found for this date, and the first of these is selected. Use run in this set, press

← →

to scan the other matches. To exit without printing results for any

and enter another date, or press

EXIT

three times to return to

EXIT

standby mode.

Step 6. Print control results.

When the result of interest is displayed, press

. The following messages are dis-

ENTER

played sequentially.

Insert card to print results.

Printing results...

Remove card.

”

Step 7. Retrieve more control results .

When the card is removed, the display returns to the screen in step 4. Repeat steps 5 and 6.

Step 8. Return to standby mode.

Press

three times.

EXIT

4.5 Scanning system QC data associated with patient results in chronological order

Step 1. Access the Recall function.

From standby mode, press

Recall: _XXXXXXX 1-Results 2-System QC ENTER to accept.

RECALL

. The display reads:

4-8 The Recall Function

Page 47

Step 2. Access System QC.

Press 2,

ENTER

Recall: _XXXXXXXX 1-Patient Set 2-Control Set ENTER to accept.

Step 3. Choose the results set of interest.

Press 1,

for patient set. The display reads:

ENTER

Select: 1 Print 1-Print System QC 2-Transmit System QC ENTER to accept

Step 4. Accept the Print System QC option.

Press

. By default, the patient ID, date, and time of the most recent run ar e displayed.

ENTER

Pt # XXXXXXXXXXXX xx/xx/xx xx:xx

to view results,

← →

ENTER to print.

Piccolo Operator’s Manual

Step 5. Scan patient results.

← →

Use either end of the list. To exit without printing results, press

to view patient results in chronological order. The analyzer beeps twice at

← → ← →

three times to return

EXIT

to standby mode.

Step 6. Print System QC results.

When the result of interest is displayed, press

. (System QC data associated with

ENTER

that result are automatically transmitted to a linked computer.) The following messages are displayed sequentially:

Insert card to print results.

Printing results...

The Recall Function 4-9

Page 48

Piccolo Operator’s Manual

Remove card.

Step 7. Scan more patient results.

When the card is removed, the display returns to the screen in step 4. Repeat steps 5 and 6.

Step 8. Return to standby mode.

Press

three times.

EXIT

4.6 Recalling system QC data associated with patient results by specifying patient

Step 1. Access the Recall function.

From standby mode, press

RECALL

. The display reads:

Recall: _XXXXXXX 1-Results 2-System QC ENTER to accept.

Step 2. Access system QC.

Press 2,

ENTER

Recall: _XXXXXXXX 1-Patient Set 2-Control Set ENTER to accept.

Step 3. Choose the results set of interest.

Press 1,

for patient set. The display reads:

ENTER

Select: 1 Print 1-Print System QC 2-Transmit System QC ENTER to accept

Step 4. Accept the Print System QC option.

Press

. By default, the patient ID, date, and time of the most recent run ar e displayed.

ENTER

Pt # XXXXXXXXXXXX xx/xx/xx xx:xx

to view results,

← →

ENTER to print.

4-10 The Recall Function

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Piccolo Operator’s Manual

Step 5. Specify the patient

Press

RECALL

. Enter the patientID. Press

memory for the specified patient

Search for patient # XXXXXXXXXXXXXX ENTER to search.

no matches

a. If

Press

ENTER

specify a different patient

were found for the specified patient

Pt # XXXXXXXXXXXX not found Press ENTER.

to return to the screen in step 4. Verify that the patient ID is correct. To

, repeat step 5. Press

mode.

one or more matches

b. If

Pt # XXXXXXXXXXXX xx/xx/xx xx:xx

nnn of ttt, ENTER to print.

are found, the display reads:

to view

← →

. The analyzer retrieves all results in

ENTER

, the display reads:

three times to return to standby

EXIT

The total number of matches found for the specified patient Individual matches, represented by order. For example, “

1 of 3

and the most recent of these is selected. Use without printing results for any run in this set, press step 4; or press

three times to return to standby mode.

EXIT

nnn,

are numbered in reverse chronological

” means three matches were found for this patient ID,

← →

to scan the other matches. To exit

to return to the screen in

EXIT

Step 6. Print system QC data.

When the run of interest is selected, press

. The following messages are dis-

ENTER

played sequentially:

Insert card to print results.

Printing results...

is represented by

ttt

The Recall Function 4-11

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Piccolo Operator’s Manual

Remove card.

Step 7. Retrieve results for a different patient

When the card is removed, the display returns to the screen in step 4. Repeat steps 5–6.

Step 8. Return to standby mode.

Press

three times.

EXIT

4.7 Scanning system QC data associated with control results in chronological order

Step 1. Access the Recall function.

From standby mode, press

Recall: _XXXXXXX 1-Results 2-System QC ENTER to accept.

Step 2. Access System QC.

Press 2,

. The display reads:

ENTER

Recall: _XXXXXXXX 1-Patient Set 2-Control Set ENTER to accept.

RECALL

. The display reads:

Step 3. Choose the results set of interest.

Press 2,

for control results. The display reads:

ENTER

Select: 1 Print 1-Print System QC 2-Transmit System QC ENTER to accept

Step 4. Accept the Print System QC option.

Press

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

ENTER

are displayed.

Control level: XXX xx/xx/xx xx:xx

to view results,

←,→

ENTER to print.

4-12 The Recall Function

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Piccolo Operator’s Manual

Step 5. Scan system QC results.

← →

Use lyzer beeps twice at either end of the list. T o exit without printing control results, press

EXIT

Step 6. Print System QC results.

When the control result of interest is displayed, press are displayed sequentially:

to view the results of control runs in reverse chronological order. The ana-

← → ← →

three times to return to standby mode.

. The following messages

ENTER

Insert card to print results.

Printing results...

Remove card.

Step 7. Scan other control results.

When the card is removed, the display returns to the screen in step 4. Repeat steps 5 and 6.

Step 8. Return to standby mode.

Press

three times.

EXIT

4.8 Recalling system QC data associated with a specific control result

Step 1. Access the Recall function.

From standby mode, press

Recall: _ XXXXXXX 1-Results 2-System QC ENTER to accept.

RECALL

. The display reads:

The Recall Function 4-13

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Piccolo Operator’s Manual

Step 2. Access System QC.

Press 2,

Step 3. Choose the results set of interest.

Press 2,

Step 4. Accept the Print System QC option.

Press

ENTER

most recent control run.

ENTER

Recall: _ XXXXXXX 1-Patient Set 2-Control Set ENTER to accept.

for control results. The display reads:

ENTER

Select: 1 Print 1-Print System QC 2-Transmit System QC ENTER to accept

. By default, the control level, date, and time displayed are those for the

Control level: XXX xx/xx/xx xx:xx

to view QC,

←,→

ENTER to print.

Step 5. Specify the control run.

Press

RECALL

. Key in the date of the control run. Press

. The analyzer retrieves all

ENTER

control results in memory for the specified date.

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

no matches

a. If

Press

ENTER

are found with the requested date, the display reads:

No control results found on xx/xx/xx Press ENTER.

to return to the screen in step 4. Verify that the date specified is correct. Use ← → to scan other control results. To exit without printing any system QC data, press

three times to return to standby mode.

EXIT

4-14 The Recall Function

Page 53

one or more matches

b. If

Control Level:XXX xx/xx/xx xx:xx

nnn of ttt,← ENTER to print.

are found, the display reads:

to view

→

Piccolo Operator’s Manual

In the message above, specified date. Individual runs are represented by

ttt

represents the total number of control runs found for the

nnn

. For example, “

1 of 3

”

means data on three control runs were found for this date, and the first of these is selected. Use

run in this set, press

← →

to scan the other matches. To exit without printing results for any

to return to the screen in step 4; or press

EXIT

three times to

EXIT

return to standby mode.

Step 6. Print system QC data.

When the run of interest is selected. The following mes sages are displayed sequentially:

Insert card to print results.

Printing results...

Remove card.

Step 7. Retrieve more control results .

When the card is removed, the display returns to the screen in step 4. Repeat steps 5 and 6.

Step 8. Return to standby mode.

Press

three times.

EXIT

The Recall Function 4-15

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Piccolo Operator’s Manual

4.9 Transmitting results to an external computer

If the analyzer is connected to an external computer, the results are automatically transmitted when the result card is printed. Follow this procedure when you wish to transmit all patient or control results currently stored in the analyzer memory to the computer eg, before reinitializing the software or before returning the analyzer to Abaxis for service. Refer to

Step 1. Access the Recall function.

From standby mode, press

Recall: _XXXXXXX 1-Results 2-System QC ENTER to accept.

Step 2. Access the Transmit Results function.

Press 9,

even though this is not shown as an option on the display

Recall: 9 All Rslts 1-Results 2-System QC ENTER to accept.

5.4

for information on reinitializing th e sof tware.

RECALL

. The display reads:

. Press

ENTER

Step 3. Choose results category.

Press 1,

to transmit all patient results or 2,

ENTER

to transmit all control results

ENTER

in memory. Up to two minutes may be required for all the results to be transmitted.

Recall: _XXXXXXXXXX 1-Patient Result 2-Control Result ENTER to accept.

During the transmission , th e display reads:

Transmitting results...

When transmission is complete, the display returns to the screen in step 1.

Step 4. Return to standby mode.

Press

three times.

EXIT

4-16 The Recall Function

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Piccolo Operator’s Manual

4.10 Transmitting system QC data to an external computer

Step 1. Access the Recall function.

From standby mode, press RECALL. The display reads:

Recall: _XXXXXXX 1-Results 2-System QC ENTER to accept.

Step 2. Access the Transmit System QC function.

Press 6,

Step 3. Choose the set to transmit.

Press 1, trol system QC data in memory. Up to two minutes may be required for all the results to be transmitted.

even though this is not shown as an option on the display

Recall: 6 All QC 1-Results 2-System QC ENTER to accept.

to transmit all patient system QC data, or 2,

ENTER

. Press

ENTER

to transmit all con-

ENTER

Recall: _ XXXXXXX 1-Patient Set 2-Control Set ENTER to accept.

During the transmission , th e display reads:

Transmitting results...

When transmission is complete, the display reads:

Recall: _ XXXXX 1-Patient Results 2-Control Results ENTER to accept.

Step 4. Return to standby mode.

Press

three times.

EXIT

The Recall Function 4-17

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4.11 No results in memory

The message

No results found in memory

may be displayed if the analyzer’s

memory has been cleared during servicing.

Step 1. Return to the Recall screen.

Press

. Verify that both patient results and control results are missing from the

ENTER

analyzer memory.

Recall: _XXXXXXXX 1-Patient Results 2-Control Results ENTER to accept.

Step 2. Return to standby mode.

Press

three times.

EXIT

4.12 No system QC in memory

In step 3 of the procedure in

4.5, 4.6, 4.7

informing you that there are no patient or control system QC data currently available in the analyzer memory. Press

to return to the Recall screen.

ENTER

Ve rify that both patient and control system QC data are missing from the analyzer memory.

Recall: _XXXXXXXX 1-Patient Results 2-Control Results ENTER to accept.

, or

4.8

, the analyzer may display a message

Step 3. Return to standby mode.

Press

three times.

EXIT

4-18 The Recall Function

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Piccolo Operator’s Manual

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 lim ited 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 w ith 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:

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. Contact Abaxis Technical Support for further assistance.

Expel a steady stream of compressed air directly into the results card slot ,

Maintenance and Troubleshooting 5-1

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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 an alyzer.

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. Th e analyzer returns to standby mode.

If the analyzer reports an error, repeat the installation procedure. If the error persists, call Abaxis Technical Support.

5-2 Maintenance and Troubleshooting

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Piccolo Operator’s Manual

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 yo ur fingers a nd pull the panel toward you. (The panel is hinged at the bottom.) The prin ter is visible when the front panel is open.

POPO

WER

E R

RECALL

E C

L L

N U

EXIT

OPEN

N C

L O

ENTER

N T

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 r emove the jammed r esult car d. 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. Th e analyzer returns to standby mode.

Maintenance and Troubleshooting 5-3

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Piccolo Operator’s Manual

Figure 5-1

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. T a ke car e 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 Tech nical Support.

5-4 Maintenance and Troubleshooting

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5.4 Reinitializing the analyzer

Reinitializing the analyz er m ay become necessary if the software becomes corrupted. A Code 28 error message is a warning that the software has b ecome corrupted and must be reinitialized.

The reinitializing process clears all results from memory and deletes all customized reference ranges.

and control results in memory following the procedures in remain in memory, and the analyzer is linked to an external computer, follow the instructions to transmit all patient and control results ( 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 customized reference ranges.

After receiving a Code 28 message, check the status of the patient

Section 4

. Follow the procedure in

3.7

and/or

4.1

4.9

) and system QC data (

4.3

and

3.8

. If results

to print or transmit

4.10

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

. The display reads:

ENTER

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

Step 3. Begin reinitialization.

Press

again. During the reinitialization process, the displa y reads:

ENTER

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. Authorization from Technical Support is required before returning an analyzer for repairs.

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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. The number helps Technical Support to diagnose the problem. Some error messages generate a troubleshooting report in addition to the error code. Print the troubleshooting report befor e pre ssing and the troubleshooting report, if applicable, at hand when calling Abaxis Technica l Support.

. Have any error codes

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 ( to acknowledge the message and open the d rawer. 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 te st ing of the second disc, record the second internal error code. Insert a result card to print a troubleshooting report. When printing is complete, press Remove and discard the disc. Call Abaxis Technical Support 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 room temperature, or power down the analyzer and move it to a warmer or cooler environment.

to acknowledge the message. Adjust the

EXIT

xxxx

). Press

EXIT

5-6 Maintenance and Troubleshooting

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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.

Press 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 temperatur e 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 dis c to ru n the sample or control.

The disc expiration date has passed. Press

the drawer. Remove and discard the disc. Verify that the analyzer is using the correct date. Refer to

3.2

control.

to acknowledge the message and open

EXIT

to acknowledge the message and open

EXIT

. Use a within-date disc to run the sample or

Code 14

Run canceled. Repeat run with new disc.

xxxx See Code 14

Maintenance and Troubleshooting 5-7

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

Record the internal error code ( to acknowledge the message and open the d rawer. 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 te st ing of the second disc, record the second internal error code. Insert a result card to print a troubleshooting report. Press open the drawer. Remove and discard the disc. Call Abaxis Technical Support with both internal error codes and the troubleshooting report at hand.

to acknowledge the message and

EXIT

xxxx

). Press

EXIT

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Piccolo Operator’s Manual

Error Message Explanation and Solution

Code 15

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

Code 21

Analyzer overheated. Refer to manual. See Code 21

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. Press

the drawer. Check the disc for insufficient or coagulated sample. Discard the disc. Use a new disc to run the sample or cont rol .

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.

Press the drawer. Remove and discard the disc. Leave the drawer open and allow the analyzer to cool down for about 15 minu tes. If ne cessary, adjust the room temperature to 32°C (90°F) or less, or move the analyzer to a cooler environment.

to acknowledge the message and open

EXIT

to acknowledge the message and open

EXIT

Code 22

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

Code 24

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

5-8 Maintenance and Troubleshooting

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 ( to acknowledge the message. The analyzer automatically shuts down. Refer to dure to reinstall the software card. If the problem persists, call Abaxis Technical Support.

Refer to jam.

5.2

for instructions on clearing a paper

xxxx

). Press

5.3

for the proce-

EXIT

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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:

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:

port.

The analyzer has been exposed to very cold temperatures or there is a problem with the analyzer hardware that cannot be corrected by r esetting the analyzer (powering down and up).Record the

internal error code ( 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 ( to acknowledge the message and shut down the analyzer. Call Abaxis Technical Support.

Press

Call Abaxis T echnical Sup-

xxxx

). Press

to acknowledge

EXIT

to acknowl-

EXIT

xxxx

). Press

EXIT

Code 27

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

Maintenance and Troubleshooting 5-9

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

Record the internal error code ( to acknowledge the message and open the d rawer. 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 with both internal error codes at hand.

xxxx

). Press

EXIT

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Piccolo Operator’s Manual

Error Message Explanation and Solution

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.

Code 33

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

Code 34

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

The software may have become corrupted and may require reinitialization. Press edge 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 sample or control before printing or recalling results.

There is a problem with the customized reference ranges stored in memory. All the ranges have been reset to the default value.#Press edge the message. Refer to customizing reference ranges.

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. Physician, operator, and patient Results cannot be restored.

to acknowledge the message. Run a

EXIT

3.6

for directions on

numbers have been erased.

to acknowl-

EXIT

to acknowl-

EXIT

Press

Section 3

and units, if necessary.

Code 35

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

5-10 Maintenance and Troubleshooting

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

Press the drawer. Remove and discard the disc. Refer to

3.2

new disc to run the sample or control.

to acknowledge the message. Refer to

EXIT

for instructions on resetting date, time

to acknowledge the message and open

EXIT

for instructions on resetting the date. Use a

Page 67

3240 Whipple Road Union City, CA 94587 Tel: 800-822-2947 Fax: 510-441-6150 Email: VetScanDxS@Abaxis.com www.abaxis.com