iNFLA QUICK PRO

USER MANUAL

Document No.: 02-184-0005

Revision No.: 1

Date: 19/10/2023
ESR Analyser User Manual

Instrument Name: ESR Analyser

Instrument Manufacturer: STRUmed Solutions Pvt Ltd

Plot No. 44, Ichhapore GIDC Industrial

Estate, Bhatpore, Off Hazira Road,
Behind Tata Motors, Surat, Gujarat
- 394510

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ESR Analyser User Manual

Table of Contents
1. Symbols and Meaning .................................................................................................................................................. 4
2. Intended Use .................................................................................................................................................................... 5
3. Improper Use ................................................................................................................................................................... 5
4. Introduction....................................................................................................................................................................... 5
4.1.Working Principle .................................................................................................................................................. 5
5. Device Installation .......................................................................................................................................................... 5
5.1. Storage and Transport ...................................................................................................................................... 5
5.2. Unpacking and Inspection ................................................................................................................................. 5
5.3. Positioning of the Device ................................................................................................................................... 6
5.4. Device Layout ......................................................................................................................................................... 7
6. System Description ....................................................................................................................................................... 8
6.1. The Analyser unit .................................................................................................................................................. 8
6.2. Optical reading assembly .................................................................................................................................. 8
6.3. Display ....................................................................................................................................................................... 8
6.4. Power supply .......................................................................................................................................................... 8
6.5. Internal Thermal Printer .................................................................................................................................. 8
6.6. Barcode Scanner (optional) ............................................................................................................................. 8
6.7. Test tubes (optional) ........................................................................................................................................... 8
7. Operating Procedure .................................................................................................................................................... 9
7.1. Device Initialisation & User Interface ........................................................................................................... 9
7.2. Wi-Fi status indicator.......................................................................................................................................... 9
7.3 Auto Print Option…..…………………………………………………………………………….……………………………………………….9
7.4. Barcode scanner (BCS) status indicator ................................................................................................ 10
7.5. Preparation of Blood Sample ....................................................................................................................... 10
7.6. Running the Test................................................................................................................................................ 11
7.7. Set-up Menu ........................................................................................................................................................ 15
7.8. Switching off ........................................................................................................................................................ 18
8. Technical specifications: ........................................................................................................................................... 19
8.1. Basic parameters ............................................................................................................................................. 19
8.2. Normal operating conditions........................................................................................................................ 19
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ESR Analyser User Manual
8.3. Storage condition .............................................................................................................................................. 19
8.4. The main functions ........................................................................................................................................... 20
9. Biological risks and safety prompts..................................................................................................................... 20
10. Troubleshooting Instructions .............................................................................................................................. 21
11. Maintenance and Repair....................................................................................................................................... 21
12. Disposal and Recycling .......................................................................................................................................... 21
13. Appendix ....................................................................................................................................................................... 22
13.1. Physiology of Erythrocyte Sedimentation Rate .................................................................................. 22

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ESR Analyser User Manual

1. Symbols and Meaning

In Vitro Diagnostic Devices

Note: Please read carefully/ Warning

Power Switch

USB Port

DC Inlet

DC Power

AC Power

Manufacturing Address

Manufacturing Date

Unit Serial Number

Fragile, Handle with care

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ESR Analyser User Manual
2. Intended Use
ESR Analyser is an automated in-vitro diagnostic device (IVD) intended to give erythrocyte
sedimentation rate (ESR) of blood samples. The device is to be used in diagnostic labs in clinics,
nursing homes and hospitals. This device shall not be connected to any patient.

3. Improper Use
Any attempts or uses with a purpose different from the intended use shall be considered as
improper use of the device.

4. Introduction
ESR analyser is an automated device developed to measure the Erythrocyte Sedimentation Rate
of blood samples. The device can measure 20 samples simultaneously. The ESR analyser provides
ESR value in 20 minutes which is equivalent to 1-hour Westergren method with an optional
temperature compensation, within a certain accuracy range. Thus, the device has a throughput of
60 blood samples in 1 hour.

4.1. Working Principle

The ESR Analyser is an automated measurement system to analyse the blood ESR value. The
principle used is based on optical photometry, in which an optical scanner assembly scans the
tubes vertically and detects the level of sedimentation continuously for 20 minutes thereby
evaluating the effective height of cell column. Based on the sedimentation occurred, ESR Analyser
displays the ESR value in mm/hour by standard Westergren method. The ESR value can be
displayed with or without temperature correction (using Manley’s Nomogram).

5. Device Installation
The user should be very careful with the installation and handling of the device. If the device is being
used for the first time, please follow the instructions below.

5.1. Storage and Transport

For the storage of the device, the conditions specified in section 8.3 must be followed.

The device should be stored in a clean, dust-free, and liquid-free place. Since it is a precision device,
utmost care should be given while transporting the device.

5.2. Unpacking and Inspection

Carefully check the package of the ESR machine for any damages and shortage. Open the package
and inspect the contents against the packing list, to ensure/confirm that all parts and accessories
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ESR Analyser User Manual
are present as per the list. A trained person is expected to perform the unpacking and inspection
of the ESR machine.

The following are the contents of the packing list,

ESR analyser - 1 no

Barcode Scanner (optional) - 1 no

Power Adapter - 1 no

Quick Reference Guide - 1 no

Allen Key - 1 no

If any of the parts/accessories are found to be missed or damaged, please contact the
seller/dealer.

5.3. Positioning of the Device

The device is expected to be installed in an analysis laboratory. The device-

(a) should be kept in a dust free environment, away from liquids and harmful gases.

(b) should be placed on a levelled surface, not beside any vibrating equipment such as
centrifuge, as ESR measurement is very sensitive to vibrations and shocks which produce
erroneous results.

(c) sudden change in temperature, pressure and humidity should be avoided as it may alter
the device parameters.

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ESR Analyser User Manual
5.4. Device Layout

Well

Display

Printer

Figure.1. Front panel view

USB Ports

Power
Socket

Power
Button

Figure.2. Rear panel view

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ESR Analyser User Manual

6. System Description
6.1. The Analyser unit
The ESR analyser is an automatic device exclusively designed for the measurement of erythrocyte
sedimentation rate. The device can simultaneously scan 20 test samples, giving a throughput of
60 samples/hour. The microcontroller-based device processes the sensor data and provides the
sedimentation value as ESR.

6.2. Optical reading assembly

The ESR analyser has an optical reading plate which uses the principle of photometry using infrared
light. This scans the tubes vertically with the help of 20 emitter-detector pairs. As soon as the tube
is inserted into one of the wells, the device detects the tube and starts the analysis. The reading
plate detects the blood sedimentation level continuously in several sweeps for 20 minutes. Based
on the rate of sedimentation occurred, the ESR value in mm/hour by Westergren method is
computed and displayed. If the temperature correction option is selected, the value will be
corrected to 18 degrees Celsius, using Manley’s Nomogram.

6.3. Display
The device uses a 3.5-inch TFT colour display with resistive touch screen and illuminated from the
back. Information such as patient Id, date, time, ESR value and test status are displayed on the
screen.

6.4. Power supply

The device is provided with a BIS certified AC-DC power adapter of 12V, 3A. The input power supply
is 150-240V, 50-60Hz.

6.6. Barcode Scanner (optional)

The device has the provision to connect a USB barcode scanner through one of the USB ports
provided for reading the patient Id from the test tubes. The patient ID can also be entered manually
by the user.

6.7. Test tubes (optional)

The test tubes for analysis of blood ESR are provided with the ESR Analyser device. The tubes
contain the anticoagulant K2 EDTA (3.6mg). For the test, tubes have to be placed vertically up in
the wells. The tubes are kept undisturbed till the test is completed and result is displayed on the
screen.

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ESR Analyser User Manual

7. Operating Procedure
7.1. Device Initialisation & User Interface
Please pay attention to the following instructions while you install the device:

• Please check whether the power cable is connected to the socket or not, to ensure the
power supply to the device.

• Place the device vertically on the surface to ensure that the tubes are vertical when they
are inserted into the wells.

• When the device is turned on, a message showing ‘Initialisation in progress...’ would appear
on the boot-up screen. Initialisation takes approximately 100 seconds.

• After the above message, the following home screen would appear on the display of the
device.

• The home screen has all the important indications like 20 wells (serial numbered) with well
status on the circle. Other indicators such as date, time, Wi-Fi connectivity status, barcode
scanner status, report storage button and set-up control button.

• Date and time are displayed on the top right corner of the home screen.

7.2. Wi-Fi status indicator

• Wi-Fi status indicator shows different colours indicating various status of the connection: -

Green colour image indicates Connected while Black colour image indicates Disconnected.

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ESR Analyser User Manual
7.3. Auto Print option
• In Auto mode, the printer automatically prints out the result after the test is completed for
any of the well. Select the Auto mode through the Set-up menu

7.4. Barcode scanner (BCS) status indicator

• BCS status indicator shows different colours indicating various status of BCS: -

Green colour image indicates Connected while red colour image indicates Disconnected.

7.5. Preparation of Blood Sample

• Patient’s venous blood is drawn into an ESR tube provided with the ESR Analyser device.
Tubes containing the anticoagulant K2 EDTA of 3.6 mg and blood has to be mixed.

Anticoagulant other than K2 EDTA, shall not be used for blood analysis.

• Fill the blood sample in the tube according to the tube markings (as shown in below figures).
Figure A shows the correct filling of blood in the test tube, B shows blood filling more than
required, C shows blood filling less than required and D shows air bubbles formed in the
tube.

A B C D

Blood Volume should not be lower than 1.5 ml.

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ESR Analyser User Manual
There should not be any formation of bubbles in the blood sample. After filling the tube, thoroughly
mix the blood sample with anticoagulant through 8 to 10 continuous tube inversions. After the
mixing, place the test tube in any well on the device and start the test.

7.6. Running the Test

There are many ways to start the test:

• Just place the test tube on any well in the device. It may take a few seconds for the test
to start. When the test tube is detected, touch the corresponding well circle (user can
touch well circle any time during the test) to enter the Patient ID in the entry screen, as
shown below.

12345678901

25

• Or, for entering manually, touch any well circle to open the entry screen. Enter the
patient ID on the space provided on the entry screen. Exit the entry screen and place
the test tube in the corresponding well.

• Patient ID can also be entered using BCS. For this, scan the barcode on the test tube
using BCS. A message will appear on the BCS indicator. Touch a well circle to
open the entry screen. Verify the patient ID and exit. Then place the test tube in the
corresponding well.

Patient ID cannot be edited after the test is completed.

• Well circle status indicators:

27

Well Selected Test in Progress Test Completed Test aborted

(value inside shows (Error)

ESR value in mm/hr)

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ESR Analyser User Manual

• Test completed/ aborted status stays till the test tube is removed.

• After the test is completed, touch the corresponding well circle to open an updated
entry screen (with test details), as shown below.

• Touch the printer icon in the above screen to print the test results.

• Touch the Data Transfer icon in the above screen to transfer the data to
Host.

• The test tube should be discarded properly after the test completion.

• In case of any errors, the error message is shown in the screen as shown below.

12345678901

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ESR Analyser User Manual

• Possible error messages:

➢ When the test tube is removed before the test completion,

“Error: Tube removed”

➢ When the blood level in the test tube is below the bottom marker,

“Error: Level low”

➢ When the blood level in the test tube is below the bottom marker,

“Error: Level high”

➢ When test duration exceeds the selected duration,

“Error: Time exceeded”

• Review results Icon: This is to store the patient information. The device has the capability to store
1024 patient information which can be reviewed and printed at any time.

• Touch the review results icon in the home screen to access the stored
test results.

• The results can be searched either by Date or Patient ID or both.

• Enter Date/ Patient ID/ both and touch the filter icon on the screen to get
the filtered test results, as shown below.

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ESR Analyser User Manual

• Touch any row in the stored results to view and print the required test results.

7.7. Set-up Menu

• Set-up menu icon is pressed to enable and change various settings on the device. Once Set-
up icon is touched, the following page 1/4 would appear: -

1/4
1/4
1/4

• Enable the ‘Auto-print’ option to print the test results automatically after the test.

• Enable the ‘Result at 18°C’ option for temperature correction (based on Manley’s
Nomogram) of the result. (At 18°C) would not appear in the result if it is not enabled in the
Set-up menu.

• Set the ‘Test duration’ to either 20 minutes.

• Enable the ‘Auto Data Transfer’ option for transferring the data automatically after the test
is completed. (This option requires Wi-Fi connectivity and Host Details, refer Wi-Fi & Host
Connection)

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ESR Analyser User Manual
Any change is affected only on new tests, not on the current tests.

• Set-up page 2/4 is for clearing patient memory and custom settings (set to factory default).

2/4

Data once deleted cannot be retrieved.

3/4
3/4

• Set-up page 3/4 is for Wi-Fi & Host Connection.

• Use the drop-down menu to select the network, after selecting the network touch on the
password entry line and an alphanumeric keypad shall appear enter password and touch
enter.

• Once the device is connected to the selected Wi-Fi network, an indication may appear as
shown below.

3/4

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ESR Analyser User Manual

• The same screen shall have Host Details, Touch enter button which will change the
screen as shown below:

• This screen requires to enter details of Host/Server, IP address and Port Number of
Host/Server shall be known and Host/Server shall be connected on same network.

• After entering details touch the enter button to confirm. The host details shall remain
saved until any changes are made.

• Set-up page 4/4 is for factory use.

• List of factory default settings:

➢ Auto print : OFF

➢ Result at 18°C : OFF

• Factory settings can be accessed only by authorised company personnel.

7.8. Switching off

• Press the power switch to turn off the device.

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ESR Analyser User Manual

8. Technical specifications:
8.1. Basic parameters
1. Loading capacity: 20 samples simultaneously

2. Throughput: 60 samples/ hour

3. Loading pattern: Random

4. Test duration: 20 minutes

5. Measuring range: 0 – 140 mm/hour

6. Temperature compensation range: 15 – 35 degree C

7. Display: 3.5-inch TFT colour resistive touch screen RPi display

8. Dimensions: 210 x 215 x 175 mm

9. Gross Weight: 3.6 Kg

10. Risk Class (as per MDR, 2017): Class A

8.2. Normal operating conditions

1. Environment temperature - 15°C - 35°C

2. Relative humidity - 35% - 80%

3. Altitude – 2000 metres

4. Input power – 12 V DC 3A max

5. AC – DC adapter - 150 – 240 V AC, 50 - 60Hz

8.3. Storage condition

1. Environment temperature - 15°C - 35°C

2. Relative humidity - 5% - 80%

3. Altitude – 2000 metres

8.4. The main functions

1. The sample could be inserted and detected at any time.

2. The device has the provision for temperature compensation, which if selected, shall correct
the final ESR value to 18-degree temperature Celsius.

3. It auto-prints the test result and patient details.

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ESR Analyser User Manual
4. The device generates audio and visual indications for tests status.

5. The device has the capability to store up to 1024 patient reports including patient ID,
date, time and ESR value.

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ESR Analyser User Manual

9. Biological risks and safety prompts

The ESR Analyser is an in-vitro diagnostic (IVD) medical device which measures the erythrocyte
sedimentation rate of blood. Please follow the warnings listed below before using the equipment.

1. Please wear protective clothing and protective gloves to avoid contact with the bio-
hazardous materials involved.

2. Please avoid contact with the following substances during handling and operating the
equipment: patient blood sample, used test tube, used blood sample, liquid waste which are
considered to be pollutants.

3. Utmost care should be taken while handling the samples, there may be a risk of causing
infections. If the blood sample overflows the tube, a fungicide can be used to wipe it off.

4. If the user comes in contact with any such harmful elements, immediately get medications
and clean it properly.

5. Please wear rubber gloves while handling the test tubes and liquid wastes.

6. The device should be handled only by professionally trained medical staff and the operation
should be done in strict accordance with the operating manual.

7. If smoke or any unusual sound is heard, immediately shut off the equipment power and
contact your dealer.

8. This equipment has no contraindications, and it does not produce any toxic or harmful
gases.

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ESR Analyser User Manual

10. Troubleshooting Instructions

Fault Cause Measure

No display after power on Power failure/ loose Check the power adapter
connection connection to plug the unit.
If green light (on the rear panel)
does not glow, call service engineer

Device not detecting tube Wrong placement of tube Remove and place the tube
properly

Display error Electromagnetic interferences Shutdown, remove the

interference source, wait for few
seconds, reboot the device

Printer could not print Printer out of thermal paper Replace the thermal paper

Printer not responding Printer connectivity issue Inspect the connectivity of printer

Barcode scanner not BCS connectivity issue Inspect the connectivity of barcode
responding scanner

11. Maintenance and Repair

The design of the product has been done in a way to reduce the complexity involved and to
maintain easily. Special attention to be given while cleaning the device, since it has sensitive
parts like infrared sensors inside the device.

Please ensure not to use liquids while cleaning the top reading plate. Liquids entering the device
may damage the parts and will impair the functions.

Contact the company for any repair of the device.

12. Disposal and Recycling

At the end of working life of the device, please ensure that the device is disposed as per the local
regulations.

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ESR Analyser User Manual

13. Appendix
13.1. Physiology of Erythrocyte Sedimentation Rate
Erythrocyte sedimentation rate (ESR) is a non-specific laboratory screening test. The principle
behind ESR measurement can be defined as ‘when an anticoagulated blood is allowed to stand
vertically, RBCs in the whole blood descend in a standardised tube in a period of 1 hour’. It is a
measure of inflammation and is determined by the interaction between factors that promote (e.g.,
fibrinogen) and resist (negative charge of RBCs that repel each other) sedimentation of the blood.
Sedimentation occurs in three stages:1) Rouleaux formation 2) Sedimentation (sinking of rouleaux
at a constant speed), 3) Packaging (slowing down of sedimentation thus packaging of cells starts).
The practical measurement follows detecting the length of fall of meniscus of the RBC column
(measured from plasma meniscus) in a unit time.

Reference Interval:

Child: 2-15 mm in 1 hour

Adult:

Male: 17-50 years: 1-10 mm in 1 hour

>50 years: 2-14 mm in 1 hour

Female: 17-50 years: 3-12 mm in 1 hour

>50 years: 5-20 mm in 1 hour

The ESR test is performed according to the International Committee for Standardization in
Haematology (ICSH). There are two basic methods to perform ESR manually which are the
Westergren and Wintrobe methods. ICSH has made Westergren method as the standard and
reliable method for performing ESR measurement manually.

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