Erythrocyte Sedimentation Rate Analyzer

OPERATOR MANUAL
Cat. No. 112-01017
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Dear miniiSED™ Customer,

ALCOR Scientific would like to welcome you into the world of fast, efficient and accurate
erythrocyte sedimentation rate (ESR) results. With our welcome, we have provided you a
packet of information to get you started. We hope this information will make using the miniiSED
even easier. Please find enclosed:

Warranty Card
The instrument is backed by a One (1) Year Warranty. To assure coverage, you must activate
your Warranty by filling out the warranty card included with your instrument and mailing it back
to ALCOR. The serial number label is located on the rear panel of the analyzer. Please see
the last page of the Operator Manual for more information and instructions.

ALCOR Scientific offers Technical Support Monday through Friday 8:30am-5:00pm EST
(excluding all US Federal Holidays) to help service you in the quickest way possible. The
Technical Support Team can be reached by any of the following:

Toll Free: (800) 495.5270 (USA Only) Fax: +1 (401) 737.4519

+1 (401) 737.3774

Mail: ALCOR Scientific Inc. Email: [email protected]

20 Thurber Blvd
Smithfield, RI 02917 USA

Please do not hesitate to contact ALCOR or your authorized ALCOR distributor if you have any
questions regarding any of the information found in this manual.

We thank you for selecting ALCOR products and look forward to serving your laboratory!

Best Regards,
ALCOR Scientific Support Team

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SYMBOL REFERENCE
The following is a list of symbols and their meaning used on the instrument, consumables and accessory
labeling.

Symbol Meaning

Instrument satisfies requirements of European directive on in vitro diagnostic medical devices

(IVDD 98/79/EC)

Date of manufacture

Manufacturer

Serial Number

In Vitro Diagnostic Medical Device

Product/Reference number

Fuse Rating (located on serial number label, replace with same value and type)

AC Single Phase Alternating Current

Consult instructions- refer operator to the instruction manual for additional information

Temperature limitation –Indicates storage requirements range

WEEE: Disposal of Waste Electrical and Electronic Equipment

Biological Hazard: Universal precautions should be followed

Caution: Moving Parts

Caution: Sharp Needle

Warning: Consult operator manual and observe safety warnings

Caution: May Cause Electrical Shock

Caution: Object is heavy. Use care and/or assistance in lifting

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Notes, Precautions, Warnings and Biological Warnings

The Operator’s Manual includes information and warnings. These need to be observed by the operator in
order to ensure safe operation of the instrument. There are four types of messages: Notes, Caution,
Warnings and Biological Warnings.

Notes

NOTE: Highlights important facts, gives helpful information and tips and clarifies
procedures.

Cautions

CAUTION: Important information on the proper operation of the instrument. This

information is crucial in preventing instrument damage and maintain the system.

CAUTION: Electrical caution! Unplug before handling.

Warnings

WARNING: Identifies potentially hazardous situations that could result in serious

injury to laboratory personnel.

Biological Warnings

WARNING: Universal precautions should be followed. Always wear gloves to prevent

exposure to pathogens.

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Precautions and Safety Information

Please pay close attention to the instructions, notes and symbols as well as the standard
laboratory practices outlined by your facility and local regulatory agencies.

Always keep a distance of at least 4 inches (10 cm) between the rear of the instrument
and the wall to allow for proper ventilation.

Do not use power frequencies or voltage other than those specified in this document.
Connection to an inappropriate power source may cause injury or fire.

Do not disassemble or modify the instrument. Doing so may cause injury and /or
instrument malfunction and void the warranty.

Place the instrument on a stable and level surface free of vibration. Failure to do so may
cause injury or malfunction of the unit.

CAUTION: To reduce the risk of electrical shock, do not remove any panel or open
housing unless under the direction of qualified personnel.

Do not block any ventilation openings.

Do not place instrument in water.

Do not drop or throw the instrument.

Operate the instrument on a dry, level surface.

Do not move the instrument while specimens are processing.

Plug the instrument into a grounded power source.

Tubes must be tightly capped prior to loading them on to the miniiSED

WARNING: For continued protection against risk of fire and hazard, replace only with
the same type and rating fuse.

WARNING: The instrument’s main power switch is used as the main disconnect device.

WARNING: Observe Universal Precautions. Discard contaminated materials according

to applicable regulations.

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TABLE OF CONTENTS
Notes, Precautions, Warnings and Biological Warnings ............................................iv
Precautions and Safety Information ............................................................................. v
1. Intended Use ......................................................................................................... 1
2. Methodology ......................................................................................................... 1
2.1.History ....................................................................................................................... 1
2.2.Comparison With Existing Methods............................................................................ 2
2.3.Method Limitations ..................................................................................................... 2
3. Principle of Procedure ......................................................................................... 3
4. General Information ............................................................................................. 3
4.1. For In Vitro Diagnostic Use Only ................................................................................ 3
4.2.Sample Requirements................................................................................................ 3
4.3.Tube Requirements ................................................................................................... 4
5. Instrument Overview ............................................................................................ 4
5.1.Consumables ............................................................................................................. 4
5.2.Parts Identification ..................................................................................................... 5
5.3.Continuous Operation Mode ...................................................................................... 5
6. Unpacking and Installation .................................................................................. 6
7. User Interface ..................................................................................................... 10
8. Calibration........................................................................................................... 17
9. Results ................................................................................................................ 18
9.1.Expected Values .......................................................................................................18
9.2.Performance .............................................................................................................18
10. Smart Cards ........................................................................................................ 18
10.1. Smart Card Menu ...............................................................................................19
11. Routine Maintenance ......................................................................................... 20
11.1. Replacing/Emptying the Waste Bottle .................................................................20
11.2. Replacing miniiWASH Bottle...............................................................................21
12. Safety Precautions ............................................................................................. 21
12.1. General Considerations ......................................................................................21
12.2. Biological Waste .................................................................................................22
13. Preventative Maintenance ................................................................................. 22
14. Technical Support .............................................................................................. 23
15. Technical Specifications ................................................................................... 24
16. Warranty Information ......................................................................................... 25

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1. Intended Use

The miniiSED Erythrocyte Sedimentation Rate analyzer, is an automated sedimentation rate analyzer which
reports sedimentation rate in mm/hr. It is a non-specific, quantitative result. Testing is done using
EDTA/whole blood samples, obtained by venipuncture or capillary blood collection. The instrument can be
used in laboratories authorized to perform test classified as Moderately Complex under CLIA categorization
by order of a physician to aid in assessing the general health status of a patient.

2. Methodology
2.1. History
The discoverer of Erythrocyte Sedimentation Rate (ESR) in 1897 was a Polish physician, Edmund
Faustyn Biernacki 1 (1866–1911). The most important conclusions from his observations were as
follows: the blood sedimentation rate is different in different individuals; blood with small amounts of
blood cells sediments faster; blood sedimentation rate depends on the level of plasma fibrinogen; in
febrile diseases (rheumatic fever included) with high levels of plasma fibrinogen the ESR is increased;
and in defibrinated blood the sedimentation process is slower. The findings presented by Biernacki
clearly showed the clinical significance of ESR.

In 1921, Swedish internist Alf Vilhelm Albertsson Westergren (1891–1968), presented a similar
description of the phenomenon of ESR 2 as those given by Biernacki and Swedish hematologist,
Robert Sanno Fåhraeus (1888–1968) 3. Westergren applied a blood sampling method to the ESR test
using sodium citrate as anticoagulant. Westergren also defined standards for the ESR test and to
which nearly all other automated ESR analyzers are referenced today. 4, 5

The miniiSED analyzer uses advanced Rheology Technology to measure the “earliest and most
critical phase” of the Erythrocyte Sedimentation, which is called rouleaux formation. The rouleaux
formation is the critical phase of ESR and the one that ultimately determines the rate at which the red
cells will settle in the Westergren tube.

The technical innovation of the miniiSED analyzers consists of “directly” measuring the aggregation
of the red blood cells, whereas the traditional ESR methods “indirectly” measure the aggregation of
the red blood cells by recording the length at which the red cells settle in a Westergren tube.

After measuring the aggregation directly, the miniiSED analyzer produces ESR results in mm/hr.
Utilizing EDTA blood from the primary tube, results are reported within seconds.

1 Biernacki E. Die spontane Blutsedimentirung als eine wissenschaftliche praktisch-klinische untersuchungsmethode. Dtsch Med
Wschr 1897; 23: 769–72.

2 Westergren A. Studies of the suspension stability of the blood in pulmonary tuberculosis. Acta Med Scand 1921; 54: 247–82.

3 Fåhraeus R. Über die Ursachen der verminderten Suspensionsstabilität der Blutkörperchen während der Schwangerschaft. Biochem
Z 1918; 89:355–64.
4 International Council for Standardization in Haematology (Expert Panel on Blood Rheology): ICSH recommendations for
measurement of erythrocyte sedimentation rate. J Clin Pathol 1993; 46:198-208.

5 Thomas RD, Westengard JC, Hay KL, et al: Calibration and validation for erythrocyte sedimentation tests. Arch Pathol Lab Med
1993; 117:719-72.

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2.2. Comparison With Existing Methods

Current ESR testing methods include manual, standing capillary tube type devices and automated
systems utilizing proprietary blood collection vials. These methods typically have test times of 20 to
60 minutes, may require open container blood transfer and minimum blood volumes of greater than
1ml, which may result in extra blood drawing.

The miniiSED erythrocyte sedimentation rate analyzer is designed to sample directly from the primary
(lavender top) 13 x 75mm, EDTA blood collection tube, automatically withdrawing a test sample of
100µL volume and can produce a result in as little as 20 seconds, with appropriate prior
homogenization. The instrument’s micro-flow cell allows capture of the critical kinetics of red blood
cells aggregation in a highly controlled testing environment. This system eliminates handling and the
associated factors that can contribute to result variability. The miniiSED reports results which have
been correlated with the Westergren method.

2.3. Method Limitations6

The erythrocyte sedimentation rate is a transient phenomenon confined to fresh blood. It is not a
hematic matrix component at the corpuscular or molecular level. The procedures used to determine
the ESR cannot be calibrated since they are susceptible to a variety of factors, e.g. temperature,
hematocrit, erythrocyte mean corpuscular volume, plasma viscosity, etc. For this reason, it is possible
to observe instrument performance deviations, compared to other procedures, when the above
variables are not considered. Erythrocyte sedimentation remains a confusing, partly understood
phenomenon and, clinically, is a nonspecific reaction. It is highly recommended to perform other tests
together with ESR since a normal ESR value is not enough to exclude that the patient is not affected
by a pathology.

Sample mixing is performed at the beginning of the analysis with the purpose of homogenizing the
sample. An inefficient homogenization can affect the results given by the instrument.

Interferences that may increase ESR values:

• Increased levels of Fibrinogen and gamma globulins.
• Technical factors such as mechanical vibrations and elevated room temperature.

Interferences that may decrease ESR values:

• Abnormally shaped RBC (sickle cells, spherocytosis).
• Technical factors: low room temperature, delay in test performance, clotted blood
sample, excess anticoagulant, or bubbles in tube.
• Specimen quality such as blood to anticoagulation ratio, age of specimen and fill volume.

NOTE: ESR is a nonspecific reaction. It is highly recommended to perform other tests together with
ESR, since an ESR value is not enough to exclude that the patient is not affected by a pathology or
to diagnose a pathology.

6 CLSI. Procedures for the Erythrocyte Sedimentation Rate Test; Approved Standard-Fifth Edition. CLSI document H02-A5.
Wayne, PA: Clinical and Laboratory Standards Institute; 2011.

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3. Principle of Procedure7
The ESR is a simple non-specific screening test that indirectly measures the presence of inflammation in
the body. It reflects the tendency of red blood cells to settle more rapidly in the face of some disease states,
usually because of increases in plasma fibrinogen, immunoglobulins, and other acute-phase reaction
proteins. Changes in red cell shape or numbers may also affect the ESR.
When anticoagulated whole blood is allowed to stand in a narrow vertical tube for a period of time, the
RBCs – under the influence of gravity - settle out from the plasma. The rate at which they settle is
measured as the number of millimeters of clear plasma present at the top of the column after one hour
(mm/hr). The RBCs sediment because their density is greater than that of plasma; this is particularly so,
when there is an alteration in the distribution of charges on the surface of the RBC (which normally keeps
them separate from each other) resulting in their coming together to form large aggregates known as
rouleaux. Rouleaux formation is determined largely by increased levels of plasma fibrinogen and globulins,
and so the ESR reflects mainly changes in the plasma proteins that accompany acute and chronic
infections, some tumors and degenerative diseases. In such situations, the ESR values are much greater
than 20mm/hr. Note that the ESR denotes merely the presence of tissue damage or disease, but not its
severity; it may be used to follow the progress of the diseased state or monitor the effectiveness of
treatment.

4. General Information
Read this manual carefully prior to operating the instrument.

This document is the operator’s manual for the instrument. It is intended to explain the instrument
operation in detail and can be used as a basis for training new operators. It is an information guide
and troubleshooting reference. Retain this manual for future use.

4.1. For In Vitro Diagnostic Use Only

4.2. Sample Requirements

Sample volume for testing is 100μL whole blood (500μL dead volume)

Sample volume for pediatric testing is 100 μL whole blood (400 μL dead volume)

Sample must be whole blood collected in K3-EDTA or K2 EDTA anti-coagulant tube

Sample should not be clotted or hemolyzed (DO NOT mix vigorously!)

Sample should be tested within 4 hours from venipuncture or within 24 hours if refrigerated

Sample must be brought to room temperature for at least fifteen (15) minutes (if refrigerated)

NOTE: The instrument requires no additional or special sample preparation. As with all anti-
coagulant collection tubes, the sample should be well mixed after collection to help avoid
clotting or other aggregates that may alter ESR test results.

7 McGill University, The McGill Physiology Virtual Laboratory, 2000.

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4.3. Tube Requirements

1.2.1 Any standard 13x75mm EDTA tube anti-coagulant (lavender top)

with pierceable cap; and
1.2.2 BD Microtainer® MAP Tube or Greiner Bio-One MiniCollect®
pediatric tubes

WARNING: Do not use if the tube stopper is missing!

Use only tightly capped samples!

5. Instrument Overview
The rate at which red blood cells aggregate in whole blood has a direct effect on the resulting sedimentation
rate. Sedimentation rate is therefore an indirect representation of the rate of aggregation. The miniiSED
erythrocyte sedimentation analyzer uses photometrical rheology to directly measure the aggregation of red
blood cells. Once the sample is automatically processed and in position, a sensitive optical detector in the
miniiSED follows the progress of aggregation over time. This produces a signal that is a direct
representation of the aggregation. The magnitude of time-dependent change is correlated to the
Westergren method.

5.1. Consumables
Consumables can be purchased by calling ALCOR Customer Service Department or your local
authorized ALCOR distributor.

Item Description Reorder Part #

Test Cards can be purchased by

Preloaded smart card for miniiSED, calling ALCOR Customer Service
Test Card
available with tests in various quantities Department or your local
authorized ALCOR distributor.

miniiWASH™ Fluid 250 mL bottle with screw cap, pre-filled

112-12-003
(4 pack) with instrument miniiWASH (4 pack)

miniiWASTE™ 300 mL plastic waste bottle with screw

112-12-004
(4 pack) cap, (4 pack)

NOTE: Only use consumables that are within their expiration date.

NOTE: Use of any other product could affect the performance of the instrument and void the
warranty.

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5.2. Parts Identification

1 1 Touch Screen
2

2 Sample Loading Port

3 Smart Card Reader

4 Ethernet Connection Port

3
5 USB Connection Ports (2)

6 On/Off Switch

7 Power Connection Port (24VDC, 2A)

8 miniiWASH Connection Port

9 miniiWASTE Connection Port

4

5
6
8
7
9

5.3. Continuous Operation Mode

It is always recommended that the instrument remain on and ready for use. Should the instrument
need to be powered off for any reason, the On/Off Switch on the back of the instrument shall be used.

NOTE: The instrument is programmed to perform self-cleaning after being idle for fifteen
(15) minutes following the last sample tested. The process takes approximately one (1)
minute and utilizes approximately 2.5mL of miniiWASH for each wash cycle. Once
completed, testing can resume as normal.

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6. Unpacking and Installation

CAUTION: The instrument weighs approximately 10 lbs. Use safe lifting techniques and
proper techniques when handling heavy objects. If necessary, obtain assistance to safely
lift the instrument.

CAUTION: If using a utility knife, extend the blade to appropriate length to avoid cutting
internal any components

6.1. Unpacking the instrument

Inspect the shipping container for any obvious signs of mishandling or shipping damage. If damage is
found, retain all package materials and immediately file a claim with your shipping carrier.

6.1.1. Position the box upright and open the top flaps
(Fig. 1)

Fig. 1

6.1.2. Remove the Power Supply and set aside (Fig. 2)

6.1.3. Remove the miniiWASH and miniiWASTE

Bottles and Bottle Tray and set aside (Fig. 2)

Fig. 2

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6.1.4. Rotate the box on its side (Fig.3)

6.1.5. Slowly slide the instrument and surrounding foam

out of the box using the brown tube found between
the foam panels (Fig.3)

6.1.6. Remove the Accessory Bag and set aside (Fig.3)

Fig. 3
6.1.7. Remove the foam panels from the sides of the
instrument (Fig.4)

6.1.8. Place the instrument on a secure, flat surface

6.1.9. Remove the instrument from the protective bag

d
c

6.1.10. Save the box and foam pieces for future use e f
b a
Fig. 4

6.2. Contents of box

Refer to Fig. 4 above

a. miniiSED analyzer (1)

b. Power supply (1)
c. Accessory bag (1), containing:
- Power cord (1)
- miniiWASH connection tube (blue) and miniiWASH Bottle Cap (1 each)
- miniiWASTE connection tubes (red) and miniiWASTE Bottle Cap (1 each)
- Warranty and Quick Start Guide (1 each)
d. Bottle tray (1)
e. Pre-filled miniiWASH bottle (1)
f. Empty miniiWASTE bottle (1)

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6.3. Bottle connections

6.3.1. Attach the Bottle Tray to the back of the
miniiSED

6.3.2. Connecting the miniiWASTE Bottle (Fig. 5, 6):

6.3.2.1. Connect the plain end of the

miniiWASTE connection tube (has red
connector at other end) to the red
miniiWASTE Connection Port on the
back of the miniiSED.

6.3.2.2. Connect the other end of the

miniiWASTE connection tube to the
miniiWASTE bottle by replacing the
plain cap with the miniiWASTE Bottle
Cap supplied. Fig. 5

6.3.3. Connecting the miniiWASH Bottle (Fig. 5, 6):

6.3.3.1. Connect the plain end of the

miniiWASH connection tube (has
white connector at the other end) to
the blue miniiWASH Connection Port
on the back of the miniiSED.

6.3.3.2. Connect the other end of the

miniiWASH connection tube to the
miniiWASH bottle by replacing the
plain cap with the miniiWASH Bottle
Cap supplied.

6.3.4. Place both connected bottles into the Bottle Fig. 6

Tray (Fig. 5).

6.4. Power connection

6.4.1. Precautions and warnings

CAUTION: Operate the instrument on a dry, level surface.

CAUTION: Always keep a distance of at least four (4) inches (10 cm)
between the rear of the instrument and the wall to allow for proper ventilation.

CAUTION: Place the instrument on a stable and level surface free of vibration.
Failure to do so may cause injury or malfunction of the unit.

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6.4.2. Connecting the power supply

6.4.2.1. Connect the Power Cord to the Power

Supply (Fig. 7).

6.4.2.2. Connect the Power Supply to the Power

Connection Port located on the back of
the miniiSED.

6.4.2.3. Place the instrument in its permanent

operating location (indoor use only) and
plug the Power Cord into a standard wall
outlet.

6.4.2.4. To power the unit on, press the On/Off

switch located on the back of the
instrument.
Fig. 7

6.4.3. Powering on
6.4.3.1. To power the unit on, press the On/Off switch located on the back of the instrument (Fig. 7)

6.4.3.2. Once the power button has been pressed the instrument will produce an audible beep, after
which the instrument is non-functional while the operating system boots up. This boot-up
process takes about 10-15 seconds.

6.5. Ethernet Connection

The analyzer is equipped with an RJ-45 Ethernet connector for Factory use.

6.6. USB Connection

The analyzer is equipped with two USB 2.0 interface connectors to facilitate the export of test results
or to connect an optional USB printer. Please call ALCOR Customer Service Department or your local
authorized ALCOR distributor for more information.

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7. User Interface

7.1. Initial set up

7.1.1. Selecting the language and date/time format
The miniiSED will recognize when it is being powered up for the first time and will guide the
user through the initial set up process of selecting a language (Fig.8) and the date/format
(Figs. 9,10). Once set up is complete the analyzer is ready for basic operation (Fig.11).

Fig. 8 Fig. 9 Fig. 10

Fig. 11

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7.2. Basic Operation

7.2.1. Running samples
Test credits are required for operation. The instrument is loaded with a predetermined
quantity of credits for initial set up and use, however additional credits in the form of ‘test
cards’ must be purchased. For information on loading additional test credits, please refer
to the section: Smart Cards.

7.2.1.1. Insert the closed, primary tube,

with the barcode facing down, into
the loading port of the analyzer,
as indicated (Fig. 12)

Fig. 12

7.2.1.2. Select ‘Confirm’ on the touch

screen to confirm that the sample
has been adequately mixed prior to
insertion (Fig. 13)

NOTE: If the sample was not properly mixed,

remove the tube from the analyzer for external
mixing prior to testing.

Fig. 13

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7.2.1.3. Once sample mixing has been

confirmed, the tube is moved into
the analyzer and the testing
process begins (Fig. 14)

Fig. 14

7.2.2. When testing is complete, the tube is returned to

the loading port for retrieval and the test result is
displayed on the touch screen (Fig. 15).

7.2.3. The instrument will return to the home screen

once the tube has been removed.

Fig. 15

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7.3. Touch Screen Menus

The instrument is touch screen controlled and all functions can be done by selecting or inputting
data on the following screens:

The Main Menu screen (Fig. 17) is From the Main Menu screen (Fig. 17)
accessed by touching this symbol in the navigation to the Result Log,
upper left-hand corner found on many of Maintenance and Settings menus can
the menu screens, see Fig 16, below: occur:

Fig. 16
Fig. 17

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7.3.1. Result Log Menu

The Result Log sub-menu is organized starting with the most recent test results shown first. Fig.18,
displayed icons, listed left to right, top to bottom are:

1) Back to main menu

2) Search – Selecting this will allow search by
either date, name, patient number, etc.
3) Recent – Is the default page view and orders
the result chronologically, with most recent first.
4) The “Papers” icon in upper right corner is for
exporting the last 7 days of records, either by
printing or electronically via USB (Fig. 18).
5) The blue “24” represents an individual test
result of a patient record.
6) The white “24” represents a Test Controls
result value/record.
7) The 8-digit number is the test or sample
number (bar code, manually entered or auto-
assigned).
8) The circle with arrows pointed out is an
“Expand” command, providing a more detailed
look at that test record. Fig. 18

Records can be exported 7 days at a time as shown in Figure 18 or individually as shown in Figure
19. In Either case, once the “Papers” icon is selected, it will bring up the Export Selection screen
(Fig. 20):

9) The destination of the files to be

Exported can then be selected
(Fig. 20).

10) Touch the Continue button to

complete the Export function.

Fig. 19 Fig. 20

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7.3.2. Maintenance Menu

The Maintenance sub-menu provides a “dashboard” for the user related functions for the miniiSED.
The circular icons with the green check mark indicate that the listed category is within preset limits.
When a miniiSED category is approaching a preset limit, the circular icon will turn yellow indicating
attention is needed soon. Should the category limit be exceeded, the icon will turn red and require
action to be taken. In Figure 21, displayed icons, top to bottom are:

1) In the “Cleaning Fluid” and “Waste Container”

categories, selecting the “Replace” button will
reset the counters (Fig. 21).
2) In the “Quick Clean” category, selecting the
“Run” button will start the cleaning process.
3) The “Test Credits” category displays the
remaining Test Credits. When a new Test
Credit Card is available, insertion of the Test
Credit Card will guide the user through the Test
Credit transfer process.

Fig. 21

7.3.3. Settings Menu

The Settings sub-menu (Fig. 22) provides the user access to functions to customize the operation
of the miniiSED for their laboratory environment. Using the guided Setup process when the
instrument is first turned on will preconfigure some of the typical settings at the time of device
installation. There are two categories of settings: General and Advanced. The General Settings
selection is accessible to the user via the Admin PIN, when activated. Otherwise it is not password
protected. Any User can view the Advanced Settings level but changes to these parameters is only
allowed once the Advanced level PIN is entered.

Fig. 22

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7.3.4. General Settings Menu

The General Settings sub-menu (Fig. 23) provides the user access to functions to customize the
operation of the miniiSED for their laboratory environment. Using the guided Setup process will
preconfigure some of the typical settings at the time of device installation. Protection of the General
Settings can be disabled by selecting the Access option.

Fig. 23

7.3.5. Advanced Settings Menu

The Advanced Settings sub-menu provides the user “Read-only” status of various operational
sensors and device settings (Figs. 24, 25, and 26). The Advanced Settings level is only accessible
to Alcor Technicians.

Fig. 24 Fig. 25 Fig. 26

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7.4. Patient Identification

Barcoded Tubes: Patient samples are read and identified by the instrument’s internal barcode
reader automatically as they are loaded into the instrument. All common laboratory barcodes are
supported, including Code 39, UPC and Code 93 formats. Note barcode location range:

Instances when patient identification cannot be read by the internal barcode reader or there is no
barcode present the miniiSED will provide the user an option to enter the patient data manually or
to run the test without entering additional data. If the latter option is selected the miniiSED will
assign a unique number to the test sample.

8. Calibration
miniiSED instruments are factory calibrated utilizing samples which are compared with results from a
unique Reference Instrument. The Reference Instrument is correlated with the reference Westergren
method. The instrument range is from 1 to 130mm/hr. During normal operation, parameters affecting
calibration are constantly monitored and, if not within expected limits, a warning is given, and further
testing prevented.

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9. Results
9.1. Expected Values
The reference values found in the table below are averages found in men, women, children and
newborns. An increase in these values can be a sign of multiple different health issues that
should be diagnosed by a physician or qualified individual.

Sedimentation Rate Reference Value (mm/hr)8

Men under 50 years old < 15
Men over 50 years old < 20
Women under 50 years old < 20
Women over 50 years old < 30
Newborn to Puberty 3-13
Newborn 0-2

The ranges provided are for reference only. All laboratories should follow their laboratory’s
protocol for verifying their own reference ranges.

9.2. Performance
Correlation:
227 samples have been tested on miniiSED and compared with results obtained from the
Westergren method. The comparisons demonstrate equivalence to the Westergren method.
See recommended miniiSED Correlation Protocol (1017-07-001) for detailed instructions.
• Sample result range 0 to 130 mm/hr
• N=227
• Slope=1.0625
• Intercept=-0.2500
• R=0.923

** These values do not indicate the expected performance of your miniiSED correlation

Repeatability/Stability:
See miniiSED Precision Test Protocol (1017-07-003) for detailed instructions.

Carry-over:
See miniiSED Inter-Sample Carry Over Test Protocol (1017-07-002) for detailed instructions.

10. Smart Cards

In order to process and analyze samples, tests, known as ‘credits’, must be downloaded onto
the instrument from a smart card preloaded with tests of various quantities.

8 Wheeler M, Thomas, MD, Chairman, Department of Pathology and Immunology, Baylor College of Medicine, February 15, 2012:
emedicine.medscape.com/article/2085201-overview.

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10.1. Smart Card Menu

The Home screen (Fig. 27) and the Maintenance sub-menu (Fig. 28) provide the user with the
number of Test Credits available. To add additional credits to the instrument the user must insert a
Test Credit card (Smart Card).

Fig. 27 Fig. 28

Once a Test Credit card (Fig. 29) is inserted, the next screen will show: the number of credits
currently on the instrument, the serial number of the inserted Test Credit card and the number of
credits on the Test Credit card (Fig. 30). If the user taps the “Confirm” bubble, all of the available
credits will be transferred to the instrument. The total number of credits is then displayed and the
user is instructed to discard the the Test Credit card (Fig. 31).

Fig. 29 Fig. 30 Fig. 31

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11. Routine Maintenance

11.1. Replacing/Emptying the Waste Bottle

WARNING: Wear Personal Protective Equipment (PPE) such as protective gloves

and safety glasses during this operation.

NOTE: A washing cycle should be run prior to replacing the waste bottle.

WARNING: Dispose liquid waste container contents in a manner consistent with local
regulations and laboratory procedures.

1. Locate the waste bottle at the rear of the instrument

2. Disconnect the LUER connector from the waste bottle screw

cap

3. Remove the waste bottle from the back of the instrument and
dispose according to your laboratory biologic waste protocol

4. Replace the waste bottle and firmly reconnect the LUER

connector on the plastic screw cap

5. Press Waste Container Empty reset button in the Maintenance sub-menu to reset
(Fig. 32).

Fig. 32

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11.2. Replacing miniiWASH Bottle

1. The miniiWASH bottle is located at the rear of the instrument

2. Disconnect the LUER connector from the miniiWASH bottle

screw cap

3. Remove the empty miniiWASH bottle, unscrew the cap and replace
it with a new miniiWASH bottle

4. Place the new miniiWASH bottle at the rear of the instrument and
firmly reconnect the LUER connector on the plastic screw
cap

5. Press Cleaning Fluid Replace reset button in the Maintenance sub-menu to reset (Fig. 33).

Fig. 33

12. Safety Precautions

12.1. General Considerations

WARNING: It is recommended that blood samples be handled wearing gloves and

that all other appropriate precautions be taken when dealing with potentially
infectious biological material.

CAUTION: The instrument should be disconnected from power supply before

performing any cleaning, maintenance, or exposing internal electrical components
and circuits.

NOTE: If used in a manner not specified by the manufacturer, the protection

provided by the equipment may be impaired and damage or injury could result.

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12.2. Biological Waste

Biological hazards can be found in all human and animal body fluids and/or tissues. While using
the instrument, it is suggested that your laboratory’s Good Laboratory Practices are followed.
Please refer to, and follow, all local regulations, department safety guidelines, and bio- safety
policies for disposal of bio-hazardous waste.

WARNING: Dispose blood tubes into a biohazard container.

WARNING: Dispose sharps into a biohazard sharps container.

WARNING: All other biohazardous waste should be deposited into a biohazard bag.

WARNING: Biohazard bags will be placed into a Medical Waste Management bin for
pick up.

WARNING: Dispose liquid waste container contents in a manner consistent with local
regulations and laboratory procedures.

13. Preventative Maintenance

It is always recommended that the instrument be kept free from dusty and particulate environments
for best performance.

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14. Technical Support

If you experience any problems while operating the instrument, please contact ALCOR Scientific Inc.,
or your local authorized ALCOR Scientific Distributor. ALCOR Scientific offers Technical Support
Monday through Friday 8:30am-5:00pm EST (excluding all USA Federal Holidays). They can be
reached by any of the following:

Toll Free: (800) 495.5270 (USA Only) Fax: +1 (401) 737.4519

International: +1 (401) 737.3774

Mail: ALCOR Scientific Inc. Email: [email protected]

20 Thurber Blvd
Smithfield, RI 02917
USA

WARNING: In the event that the instrument must be returned for service,
REMOVE ALL FLUID CONTAINERS BEFORE SHIPPING.

CAUTION: Remove any liquid waste or on-board

` sample tubes and decontaminate
before returning for service.

Any instrument containing accumulated blood must be cleaned prior to shipment to the
manufacturer. This decontamination is required by Federal Law (Title 48 and 49 of the Federal
Regulations) in accordance with the Environmental Protected Agency’s Regulations for Biohazard
Waste Management.

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15. Technical Specifications

Name of Device miniiSED™

Automated analyzer for the determination of erythrocyte

Type of Device
sedimentation rate of human whole blood
Principle of Measure Photometric Rheoscope

Sample Requirements 100μL whole blood (500μL dead volume)

Analytical Range 1-130mm/hr

Displayed; first result available 20 seconds once processing
Results
is started
Ethernet Port For manufacturing connection

Barcode Internal

Printer Accessory

Operating Environment 10˚- 30˚ C, Indoor Use, Pollution Degree - 2

Storage/Transport
-20˚ to 60˚ C
Environment
Humidity 15% to 85% (non-condensing)

Power Supply Transformer: 100-240 VAC, 50/60Hz; Device: 24VDC, 2A

Power Consumption 60W

Frequency 50/60 Hz

Over Voltage Category Category II

36 x 19 x 24 cm
Dimensions (L x W x H)
14 x 7.5 x 9.5 in
4.5 kgs
Weight
10.0 lbs.
Operational Altitude 4000 Meters

Storage Altitude 4000 Meters

Restrictions For Professional Use Only

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16. Warranty Information

Manufacturer’s Warranty

ALCOR Scientific Inc., warrants that this product is free from defects in materials and workmanship for
a period of One (1) Year from the date of original purchase (except as noted below). During the stated
one (1) year period, ALCOR Scientific shall, at its sole discretion, repair or replace at no charge to the
original end use purchaser or person receiving the product, any product found to be defective due to
material or workmanship. In the case of replacement, a new or reconditioned product may be provided
at ALCOR’s option. This warranty is limited to the repair or replacement due to defects in parts or
workmanship and shall not include any maintenance and repairs or replacement of parts due to normal
wear and tear. Parts required which were not defective shall be replaced at additional costs, and
ALCOR Scientific shall not be required to make any repairs or replace any parts which are necessitated
by abuse, accident, alteration, misuse, neglect, maintenance by other than ALCOR Scientific, an
authorized ALCOR service agent, or failure to operate the instrument in accordance with instructions.
Further, ALCOR Scientific extends no warranty for malfunction or damage to its products resulting from
improper or unreasonable use or maintenance; failure to follow operating instructions; connections to
improper voltage supply; unauthorized alteration or modification of original condition; damages caused
by inadequate packing or shipping procedures; loss of, damage to or corruption of stored data; and any
damage due to use of operating supplies other than those manufactured or recommended by ALCOR
Scientific. ALCOR Scientific reserves the right to make changes in design or software of this instrument
without obligation to incorporate such changes into previously manufactured instruments.

Disclaimer of Warranties
THIS WARRANTY IS EXPRESSLY MADE IN LIEU OF ANY AND ALL OTHER WARRANTIES
EXPRESS OR IMPLIED INCLUDING THE WARRANTIES OF MERCHANTABILITY AND FITNESS
FOR USE.

This warranty is void if the label bearing the serial number has been removed or defaced.

Limitations of Liability
In no event shall ALCOR Scientific be liable for indirect, special or consequential damages, even if
ALCOR Scientific has been advised of the possibility of such damages. Any transport costs and risks
are not covered by this warranty. In the event the instrument shall be returned to ALCOR Scientific for
servicing, replacement or for other reasons, it must be shipped and received in original packaging.
Otherwise, additional charges may be incurred. Proof of purchase from an authorized ALCOR
distributor and proof of delivery may be required.

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ALCOR Scientific Inc.

20 Thurber Boulevard
Smithfield, RI 02917 USA
(T) + 1 401 737-3774
WWW.ALCORSCIENTIFIC.COM