Abaxis Piccolo User manual

Operator’s Manual

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

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

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

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

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

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-

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

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

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

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

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-

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

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

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

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

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

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

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

+ 46 hidden pages

Abaxis Piccolo User manual

Specifications and Main Features

Frequently Asked Questions

User Manual

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

Section 1: Piccolo Features and Components

2.3.2 Abnormal results: interpretation and further action 2-7

Section 3: The Menu Function

Section 4: The Recall Function

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

Section 5: Maintenance and Troubleshooting

Section 1: Piccolo Features and Components

1.1 Intended use

1.2 Universal precautions

1.3 Near-patient testing efficiency

1.4 Overview of the procedure

1.5 External features

1.5.1 Display and keypad

1.5.2 Disc drawer

1.5.3 Result card slot

1.5.4 Power supply

1.5.5 Computer ports

1.5.6 Symbols used in labeling

1.5.7 Physical and environmental specifications

1.6 Internal components

1.6.1 Optics

1.6.2 Microprocessors and memory

1.6.3 Software

1.7 Piccolo reagent discs

1.7.1 Disc structure and function

1.7.2 Disc storage and handling

1.8 Result cards

1.9 Intelligent QC (iQC™)

1.9.1 Instrument iQC™

1.9.2 Reagent iQC™

1.9.3 Performance iQC™

1.10 Setup and power supply

1.10.1 Shipping verification

1.10.2 Powering up

Step 1. Connect the power supply.

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

Step 3. Check the date and time.

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

Step 5. Perform control testing.

1.10.3 Powering down

1.11 Connecting to an external computer

1.12 Consumables and ancillaries

1.13 Customer service and technical support

2.1 Sample requirements

2.2 Testing procedure

2.2.1 Preparing the reagent disc

Step 1. Dispense the sample.

a. Fill the sample port.

b. Fill the sample chamber.

c. (Optional) Label the disc.

d. Carry the prepared disc to the analyzer.

2.2.2 Running a patient sample

Step 2. Open the drawer and insert the disc .

Step 3. Select the reference range set.