ERBA ELite 3 User Manual

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Erba Lachema s.r.o., Karásek 2219/1d, 621 00 Brno, CZ

ELite 3

Hematology Analyzer

USER MANUAL

INS00066

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Content

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Table of Contents

1. INTRODUCTION .................................................................................................. 5

1.1. Intended Use ................................................................................................. 5

1.2. The Instrument .............................................................................................. 5

1.2.1. Patient Testing ....................................................................................... 6

1.2.2. Reagents ............................................................................................... 7

1.2.3. Technical Operation ............................................................................... 7

1.2.4. Calibration .............................................................................................. 7

1.3. Instrument features ....................................................................................... 8

1.4. Parts of the Analyzer ................................................................................... 11

1.5. The measurement process ......................................................................... 11

1.5.1. Control Panels ..................................................................................... 12

1.5.2. Display ................................................................................................. 12

1.5.3. Touch screen ....................................................................................... 12

1.6. Control Material ........................................................................................... 13

1.7. Accessories ................................................................................................. 13

1.8. Specifications .............................................................................................. 14

2. INSTALLATION ................................................................................................. 15

2.1. General information ..................................................................................... 15

2.2. Environmental factors ................................................................................. 15

2.2.1. Electrical requirements ........................................................................ 15

2.2.2. Space requirements ............................................................................. 16

2.2.3. Peripherals ........................................................................................... 16

2.2.4. Reagents and waste handling .............................................................. 17

2.2.5. Maintenance ........................................................................................ 17

2.2.6. Cleaning ............................................................................................... 17

2.2.7. General points ...................................................................................... 17

2.3. Unpacking and installation .......................................................................... 18

2.3.1. Turning the Instrument ON, MAIN Menu .............................................. 20

2.3.2. Turning the Instrument OFF ................................................................. 21

2.3.3. Preparing for shipment ......................................................................... 21

2.3.4. Handling in Emergency ........................................................................ 22

2.3.5. Warning labels on the analyzer ............................................................ 23

3. MENU SYSTEM ................................................................................................. 24

3.1. General Information .................................................................................... 24

3.1.1. Navigating in the Menu System ........................................................... 24

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3.1.2. Touch screen calibration ...................................................................... 24

3.1.3. Menu structure ..................................................................................... 25

4. OPERATING PRINCIPLES ............................................................................... 27

4.1. Impedance Method ..................................................................................... 27

4.2. Principle of HGB Measurement ................................................................... 27

4.3. Parameters ................................................................................................. 28

4.4. Absolute and Linearity Ranges of Parameters ............................................ 29

5. ROUTINE UTILIZATION and MEASUREMENT ............................................... 30

5.1. Sample handling ......................................................................................... 30

5.2. Sample analysis .......................................................................................... 33

5.2.1. Sample preparation .............................................................................. 33

5.2.2. Running a (new) sample ...................................................................... 33

5.2.3. Results ................................................................................................. 36

5.2.4. Warning flags ....................................................................................... 37

5.2.5. Parameter Limits (Normal ranges) ....................................................... 39

5.2.6. Blank Measurement ............................................................................. 39

5.2.7. Using Pre-diluted Mode ....................................................................... 40

6. DATABASE ....................................................................................................... 41

6.1. Database services....................................................................................... 42

6.2. The Filter / Select function .......................................................................... 43

6.3. Printing records ........................................................................................... 44

6.4. Manage records .......................................................................................... 45

7. MAINTENANCE ................................................................................................. 46

7.1. Cleaning ...................................................................................................... 46

7.2. Calibration ................................................................................................... 47

7.2.1. Calibration with factors ......................................................................... 48

7.2.2. Calibration by measurement ................................................................ 48

7.3. Quality control ............................................................................................. 50

7.3.1. References........................................................................................... 51

7.3.2. Measure ............................................................................................... 51

7.3.3. Diagram ............................................................................................... 51

7.3.4. Database ............................................................................................. 52

8. Diagnostics ....................................................................................................... 53

8.1.1. Device Information ............................................................................... 53

8.1.2. Self Test ............................................................................................... 53

8.2. Reagent status ............................................................................................ 54

8.2.1. How to empty waste container ............................................................. 55

8.2.2. Neutralization of Waste ........................................................................ 55

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9. Settings ............................................................................................................. 56

9.1. Printer settings ............................................................................................ 56

9.2. General settings .......................................................................................... 58

9.3. Measurement .............................................................................................. 58

9.3.1. Unit settings ......................................................................................... 59

9.3.2. Normal ranges ..................................................................................... 59

9.3.3. Profile ................................................................................................... 60

9.3.4. Settings ................................................................................................ 60

9.4. Date and Time ............................................................................................ 61

9.5. Multi user mode........................................................................................... 62

10. PRINTING .......................................................................................................... 65

10.1. Printouts ...................................................................................................... 65

11. Troubleshooting ............................................................................................... 67

11.1. Regular Troubleshooting Procedures .......................................................... 67

11.2. Weekly User Maintenance .......................................................................... 67

11.2.1. Cleaning needle washing head ............................................................ 67

12. Fluidic Schematics ........................................................................................... 68

13. Reagent consumption ..................................................................................... 69

14. Appendix A ....................................................................................................... 70

15. Contact .............................................................................................................. 71

16. Appendix- package inserts for reagents and cleaning solutions ................ 72

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1. INTRODUCTION

1.1. Intended Use

This hematology analyzer is a fully automated cell counter designed for in vitro diagnostic use, developed for small clinics and point-of-care lab offices.

1.2. The Instrument

ELite 3 is a fully automated, bench-top hematology cell counter. It implements the so-called Coulter-method for counting cells passing through a small

aperture, and measures the hemoglobin content of red blood cells. The analyzer features a color graphical LCD display module with touch screen, and

has a separate START button. The software allows sending results to an external printer (via USB port), or can have

an optional, 58 mm built-in thermal printer module.

Its internal memory is capable of storing 1000 records with full histograms, and individual patient data. QC measurements are also stored in separate database. The software operating the instrument is easy to upgrade using a USB pen-drive. The instrument allows connecting to a host computer for uploading records stored in the memory through a USB B (slave) port. Archiving and restoring of records to and from USB pen-drive is also possible.

NOTE

If the equipment is used in a manner different from which the manufacturer specified, the protection provided by the equipment may be impaired. Misuse of equipment or use other than its intended purpose will invalidate conditions of warranty. The accuracy and precision may also be impaired.

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1.2.1. Patient Testing

The analyzer can process 80 samples per hour in 3-part WBC differential mode. Samples can have individual sample data, and additional parameters.

You can print results to an external or to the optional built-in printer. The user can customize the report format.

The analyzer determines the following 20 hematology parameters, including 3-part WBC differential, from a 25 µl whole blood sample:

WBC total white blood cell count LYM lymphocytes count MON monocytes count GRA granulocytes count

LYM% lymphocytes percentage MON% monocyte percentage GRA% granulocytes percentage

HGB hemoglobin RBC red blood cell count HCT hematocrit MCV mean corpuscular volume MCH mean corpuscular hemoglobin MCHC mean corpuscular hemoglobin concentration RDWc v red cell distribution width* RDWsd red cell distribution width*

PLT platelet count PCT plateletcrit (trombocrit) MPV mean platelet volume PDWcv platelet distribution width* PDWsd red cell distribution width*

* RDW and PDW parameters have two forms of representation: CV and SD. Both parameters describe the distribution width, but from different aspects. User can select the units to use for displaying RDW and PDW parameters.

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1.2.2. Reagents

Use only reagents supplied by the manufacturer with the analyzer, otherwise accuracy cannot be guaranteed. All reagents are stabilized and micro-filtered. Reagents are environmental friendly, azide-free and do not contain harmful ingredients. Please refer to the MSDS associated with reagent. Store reagents between +15 and +30°C. Do not use reagent beyond the expiration date printed on the container label. Discard opened container after 120 days. Do not use reagent once frozen. These reagents are ready for use and can be applied straight from the container; no special reagent preparation is necessary. Leave the reagent at room temperature for at least 12 hours before using.

Cat. No. Product name Volume

HEM00004 Erba Diluent- Diff 20 l HEM00008 Erba Lyse- Diff 1 l HEM00001 Erba Cleaner 1 l

Additional cleaning solutions:

HEM00017 Erba Clenz 1 l HEM00016 Erba Hypoclean 1 l

For package insert for reagents and cleaning solutions please see Appendix

1.2.3. Technical Operation

As the cell counter is a fully automated instrument, operating it requires minimal training or technical support. Operator interaction is reduced to the following:

• Perform a Blank Measurement in case the instrument is not used for a specific time

• Enter sample and/or patient data

• Insert the sample to be analyzed into the sample holder

• Print results either one-by-one, or in groups by selecting records from the

database

• Perform simple weekly maintenance, as described later in this description (7.1.2.).

1.2.4. Calibration

EELLiittee 33

arrives to your laboratory factory-calibrated and ready to use. However, calibration needs updating whenever you find that the results have slightly changed, or a different or new control material is used. With each control material you receive for the instrument, you will find a control sheet listing the parameters the instrument should match. Perform these calibrations as explained in a later chapter (7.2).

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1.3. Instrument features

Figures 1 and 2 show front and rear view of the analyzer, with controls and

connectors.

Figure 1. Front view

Color LCD

touchscreen

START button

Built-in

thermal

printer

Sample holder

with

interchangeable

adapters

Front panel USB

socket

Status indicator

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Figure 2. Rear view

Instrument label

(S/N, manuf.data)

Reagent

connectors

Power switch

USB A

connectors

External grounding connector

USB B

connector

Built-in

thermal

printer

Reagent Lock

connector

Power source

connector

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To replace paper in the printer:

- open the paper lid (pull the lid upwards by the handle)

- remove central plastic roller of old paper roll

- unwind new paper roll, so that the “starting edge”

is coming from down under towards you

- gently drop the new roll into the holder of the printer, and hold the “starting edge” with your hand, and make sure it comes out on the front of the printer

- close the lid, making sure that the paper is captured between the lid and the front of the printer

The analyzer works with an external power supply. The power supply module has a so-called auto range input, allowing operation on 230V or 115V power system. The power supply unit complies CE and UL safety certifications.

The input socket is a standard power cable connection and the output is a DC jack.

CAUTION! Use only the provided power supply with the instrument:

“GlobeTek Electronics Corp.” Model ID: GT-81081-6012-T3

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1.4. Parts of the Analyzer

The hematology analyzer is composed of three main units:

Fluidic System: Performs sampling, diluting, mixing, and lysing

functions. Generates the regulated vacuum used for moving cells through the aperture during the counting process.

Data Processing System: Counts, measures and calculates blood cell

parameters, generates and stores numerical results and histograms.

Control Panel: Features an LCD display, touch screen, START

button, status LED, and USB port interfaces.

1.5. The measurement process

For the Schematics of the fluidics system, see Section 13.

Sample aspiration and dilution:

Stages of the blood testing process

25 µl of anti-coagulated (K3-EDTA) whole blood sample is aspirated into the

sampling needle, and mixed with 4 ml of diluent and stored in the chamber

(MIX dilution).

25 µl of the MIX dilution is aspirated into and stored in the needle during WBC

measurement and hemoglobin analysis

Lysing reagent is added to the mix dilution held in the WBC chamber for

WBC differential analysis. This amount of lysing reagent is patient type

dependent and the operator can change it.

After WBC counting, HGB reading and washing process, 4 ml of diluent is

added to the second dilution (using the 25 μl of mix dilution stored in the

needle).

This portion is analyzed for RBC count, PLT count and their parameters.

Another washing process prepares the unit for the next analysis.

Table 1.

Dilution rates used: Measurement times:

MIX dilution

1:160 WBC count 12 seconds

RBC dilution

1:32 000 HGB measurement 3 seconds

WBC dilution 1:196 (depends on lyse amount)

RBC/PLT count 12 seconds

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1.5.1. Control Panels

START button

Pressing and releasing the START button triggers an analysis cycle.

Status indicator

A two-color (red/green) LED (light emitting diode) is located above START button. Its actual color indicates the status of the analyzer.

LED color Analyzer status

•

Green

The analyzer is ready to measure sample. Analysis can be initiated by pressing START button.

∗

Red blinking

Blood sample can be removed when the LED blinks red 3 times and the instrument beeps 3 times.

•

Red

The analyzer is currently performing an analysis. No new measurement can be started.

•

Yellow

The analyzer is performing a maintenance process.

∗

Yellow blinking

The instrument is in stand-by and display light is off. Hit the screen to have SW wake up from stand-by.

1.5.2. Display

The display is 320 x 240 dots, high contrast backlit high-color graphic LCD module, with integrated touch screen.

1.5.3. Touch screen

The LCD screen has a touch-sensitive foil on the front surface. If the operator touches the LCD active area gently, the analyzer can recognize it and identify the position where the screen was pressed. By touching (slightly pressing) one small spot on the touch screen, the SW will activate the function/menu/key that the corresponding area represents.

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1.6. Control Material

The analyzer allows continuous monitoring of measurement performance with Erba Hematology Control (Low, Normal, High) - control blood. This must match the types

of samples usually run on the instrument. Specification for this material (assay values and allowed tolerances along with expiry date) is always packed with the approved control material.

1.7. Accessories

Below is a list of accessories shipped with your analyzer. This list can also be referred as the “EELLiittee 33 - pack”

EELLiittee 33

Hematology Analyzer User's Manual (this booklet) Reagent Tubing kit (with colored tubes)

Diluent tube (green) Lyse tube (yellow) Cleaner tube (blue)

Waste tube (red) Cleaning Tube Kit. Caps for reagent containers (matching connector colors). Waste Container (20 L). External power supply and power cable. Sample tube adapters. Optional: spare thermal roll-paper.

Reagent Tubing Kit: Cleaning Tube Kit:

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1.8. Specifications

Sample volume

25 μl of whole blood in normal 3-part or non-diff mode 50 μl of whole blood in pre-diluted mode

Chambers

2 counting chambers for diluting whole blood and counting

Reagent system

Isotonic Diluent, Lyse, Cleaner

Aperture diameter

70μm (RBC/PLT), 100μm (WBC)

Throughput

80 tests/hour

Characteristics Parameter:

Accuracy

Reproducibility

(CV)

Carry-over

sample to

sample

Test range Unit

WBC

3% 3% <1% 4.0-20.0 103/μl

RBC

<1% 4.0-15.0 106/μl

HCT

<1% 25.0-50.0 %

MCV

N/A 60-100 fl

HGB

<1% 9-16 g/dl

PLT

<3% or <20 200-900 103/μl

Sampling method

Open tube system with automatic sample rotor.

Sample types

Human (general), male, female, baby, toddler and child.

Clog prevention

High-voltage pulse on aperture in each analysis cycle, chemical cleaning and high pressure back-flush of the aperture using Cleaner reagent.

Cleaning procedure

High-voltage burst of the aperture, high-pressure back-flush, chemical cleaning of the aperture using Cleaner reagent.

Calibration

1- or more-measurement automatic and manual (factors) calibration of WBC, HGB, RBC, PLT, MCV (or HCT), RDW, and MPV.

User interface

Easy-to-use, menu driven user interface with touch-screen and separate START button, status LED

Languages available

English, Spanish, Portuguese, French, Russian, Indonesian, German, Italian, Czech

Data capacity

1000 results, with RBC, PLT, and WBC 3-part histogram

Host computer interface

USB B port

Data back-up method

USB mass storage device

Software upgrade method

via USB A port using USB mass storage device

Printer interface

USB with support for HP printers (DeskJet, LaserJet, PCL3, PS, LIDIL)

Built-in printer

Axiohm thermal printer module, 58 mm wide roll paper, full report with histograms

Display

320x240 -dots, high-contrast, backlit, color graphics LCD (liquid crystal display)

User interface

Full-LCD Touch-screen + separate START button, red/green state LED

External keyboard

USB keyboard via USB A port

Power requirement

12VDC, 5A, 60W max. operating power

Power supply unit

External, auto-ranging power unit for 100-120 or 200-240 VAC, 50–60Hz

Operating temperature

59–86 °F (15–30 °C). Optimal temperature is 77 °F (25 °C)

Dimensions (W x D x H)

12.6 x 10.2 x 14.4 in (320 x 260 x 365 mm)

Net weight

12 kg

Storage tempera

ture

3 – 35°C

Transport temperature

5 – 40°C

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2. INSTALLATION

2.1. General information

This chapter provides instructions for the installation of EELLiittee 33 hematology analyzer. The procedures described below must be followed correctly to ensure proper operation and service. Please carefully read and follow all instructions in this User’s Manual before operating the analyzer.

This hematology analyzer is a precision instrument: handle with care. Dropping or other improper handling of the instrument will disturb calibrated mechanic and electronic components and/or cause damage.

CAUTION: Always handle the instrument with care.

2.2. Environmental factors

Operate EELLiittee 33 within the ambient temperature range of 15 - 30°C and relative humidity of 45% - 85%. The optimum operating temperature is 25°C.

Avoid using the instrument in areas of extreme high or low temperatures or where it is exposed to direct sunlight. If kept at a temperature less than 10°C, the instrument should be allowed to sit for an hour at the correct room temperature before use.

Reagents should be stored at a temperature range of 18 - 30°C. Place the instrument in a well-ventilated location. Do not place it near potentially

interfering devices capable of emitting radio frequencies (e.g. radio or television receiver, radars, centrifuge, X-ray devices, fans, etc.).

Operation at an altitude over 3000 meters (9000 ft) is not recommended, because the throughput will be degraded.

Instrument is safe for transient voltages to INSTALLATION CATEGORY II and POLLUTION DEGREE 2.

Environmental and electrical characteristics provide accuracy and precision of the instrument and maintain a high level of operational safety for lab personnel.

2.2.1. Electrical requirements

EELLiittee 33

comes with an approved power cord, appropriate for your power system.

Proper use of the appropriate power cord assures adequate grounding of the system.

WARNING: Improper grounding of the analyzer bypasses important safety

features and may result in electrical hazard.

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2.2.2. Space requirements

It is important to install the instrument in a suitable location. A poor location can adversely affect its performance. Consider the following space requirements:

- Select a location near a power source and close to a suitable drain.

- Place the unit on a clean and level surface.

- Leave at least 0.5m (20in) space on both sides and above the instrument to

access pneumatics and (optional) built in printer. Provide a minimum of 0.2m (8in) between the rear panel and the wall to allow for heat dissipation and tube clearance.

- Install the reagents in a suitable place that will make your work easy. The best place is on the ground, below the supporting desk of the instrument. The pneumatic system is capable of aspirating reagents from containers being 1m (3ft) below the reagent inputs. Make sure the reagent tubes are not bent, broken, twisted or blocked in between the desk the instrument is on and the wall behind. Such circumstances can result in instrument operation failure.

- DO NOT PLACE the reagents above the instrument, as there can be a risk of falling and spilling.

WARNING: Install the unit on a table or workbench. If the unit was installed

without a supporting desktop under the unit, there is a possibility that the analyzer could accidentally fall.

2.2.3. Peripherals

Connect external peripherals only when both the instrument and the peripheral device are off. Possible peripherals are:

- external printer

- the printer must be recommended by authorized technician

- the printer must be approved and listed

- the printer must have a CE mark

- external keyboard

- the external keyboard must be approved

- the external keyboard must have a USB port or suitable adapter

- link to host computer via USB port

- serial link cable must be approved by technician

- USB B port (linking to host computer) requires a USB A-B cable and

USB driver software (contact service for availability)

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2.2.4. Reagents and waste handling

Handle reagents according to national or international regulations.

WARNING! Reagents may cause corrosion and skin irritation. If any of the

liquids leaked onto the cover of analyzer or the furniture, wipe it off immediately. In case of skin contact, rinse the liquid off with plenty of water.

Waste generated by the unit is biohazard material. Handling and disposal must happen according to regulations regarding reagent systems. See Section 7.3.2.

WARNING! Waste contains poisonous substances (because of chemical

content) and human origin substances meaning biohazard. These substances are representing potential danger to environment. For this reason, safe handling of the waste liquid is very important.

2.2.5. Maintenance

The user should check the following components weekly:

- bottom of washing head for salt build up – should be wiped off with a damp cloth or wiper

- tubing system – by opening the side door and look for any liquid leakage. If you experience leakage, contact authorized technician.

WARNING! The power supply unit and internal electronic boards must NOT be

opened or serviced by the user!

2.2.6. Cleaning

Clean the instrument and its power supply – in off state – on the outside only, using a damp cloth with a soft detergent. DO NOT let liquids get inside these units.

2.2.7. General points

The manufacturer guarantees work safety reliability and general characteristics under the following conditions only:

- services and repairs are performed by an authorized technician

- the electrical system of the laboratory follows national and/or international

regulations

- the system is operated according to instructions contained herein

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2.3. Unpacking and installation

1. Carefully remove the analyzer from the shipping carton. Inspect the

instrument for any visible signs of damage incurred during shipping. Would you find any damage, file a claim with the carrier or your distributor immediately. Check the accessories received against the packing list. Contact Service if anything is missing.

CAUTION! Prior to initial operation, allow the instrument to reach room

temperature (approx. 2 hours). Rapid temperature changes in an operating unit can lead to water condensation, which may damage electronic parts, and cause malfunction.

2. Place the instrument on a firm work surface in the designated work area,

near an appropriate AC electrical outlet. The power outlet connection MUST be grounded.

NOTE Before making connections: Make sure that all power is in “OFF”

state before connections (printer, external keyboard) are made. Carefully read all literature accompanying the instrument and its accessories. Pay particular attention to the operating procedures for the external printer.

3. Keyboard and external printer

Attach the keyboard cable to one of the USB A ports on the back of the instrument. Attach both ends of the printer cable to the appropriate ports on the printer and EELLiittee 33. Attach the AC adapter to the printer (if required) and plug it into an AC outlet.

4. Host Computer

The instrument has a built-in USB B port that allows connection to a host computer. You can export results, including histograms. USB B I/O settings are located in Settings menu.

For installation instructions for communication, please, contact Service.

5. Power supply

Connect the power supply to the instrument. Attach power cord outlet to the external power supply of EELLiittee 33 and plug the other end into a properly grounded AC outlet.

WARNING: Do not switch on the analyzer before connecting external power

supply to it and to the AC outlet, as well as before connecting an external printer or a keyboard to the analyzer.

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6. Reagent Containers

Place the reagent containers near the instrument, to an accessible location. Do not place the containers to a higher position than that of

EELLiittee 3

3, because would a tube come off its connector, the fluids spill out. Use the supplied connecting tubes and special bottle caps. Be sure that the color on each tube and cap match. You can, for example, place the reagent containers below the desk the analyzer is installed on, as the instrument has sufficient power to draw the liquids from a lower location.

All containers should be left open (do not block the small air vent hole on

the special container caps) in order to provide free airflow.

Figure 5. Reagent connections

WARNING! Reagents may cause corrosion and skin irritation. If any of liquids

leaked to cover of analyzer or the furniture, wipe it off immediately. In case of skin contact, rinse the liquid with plenty of water.

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2.3.1. Turning the Instrument ON, MAIN Menu

a. In case you use an external printer (for information, read manual

shipped with the printer) connect it and turn it on.

b. Turn the analyzer on using the power switch on the rear panel. The

‘ON’ position is marked by the ‘I’ symbol.

After turning on power, there will not be LCD activity for a few seconds, but the status LED goes on. During start-up, the following screen is displayed.

When SW is loaded, Main menu is displayed. Tap a touch-screen item to go activate the

menu element.

CAUTION! Wait 5 minutes before initiating any measuring process to allow

the instrument to reach the optimal working temperature.

In some cases, a priming cycle is necessary prior to sample introduction. The instrument will perform priming cycle automatically if additional liquid in the tubing system is required.

Run a priming cycle in case of:

• installation

• extended time out of use

• replacement of any component related to the Fluidic System

• replacement of reagents with instrument turned on

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2.3.2. Turning the Instrument OFF

DO NEVER turn off the analyzer by simply flipping the power switch on the rear panel. Doing so may result in erroneous operation during later use. It can be so, because the instrument uses diluent. This liquid is an isotonic saline solution containing salt. Would it not be washed out of special units of the instrument or would chambers not be filled with this solution may lead to dust condensation or salt build up. Therefore always follow the instructions below when switching the instrument off.

In Main menu, select SHUTDOWN. The following screen appears.

EXIT SHUT DOWN Select Shutdown.

The analyzer will perform the necessary steps to prevent failure to the pneumatic system, and then gives a tone indicating that it is safe to shut it off.

Turn off power using the rear power switch.

Turn off the instrument using the power switch on the rear panel. The ‘OFF’ position is marked by ‘O’ symbol.

2.3.3. Preparing for shipment

Use the second item in the Shutdown menu when the instrument is to be shipped or left unused for a longer time (more than 1 week). The instrument will ask you to use the cleaning tube kit and 100ml of distilled water.

Follow the instructions appearing on the display.

SHUTDOWN Preparing for shipment (2)

Remove tubing connectors, so the system can drain itself.

Leave the waste connector attached.

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Next, you should connect the cleaning tube kit to the reagent inputs, submerging the free end in a bottle containing at least 100 ml of distilled water.

Cleaning tube kit connected The analyzer will flush any remaining reagents from the system into the waste container.

As a next step, the analyzer asks you to

remove the cleaning tube kit. Leave Waste connected.

When finished, the analyzer prompts you to power off the system. Remove the

waste connector after shutting down.

2.3.4. Handling in Emergency

In case of emergency situation - like instrument catching on fire (short-circuit, etc.) - cut off power immediately by disconnecting mains power or DC input line, and use a fire-extinguisher if necessary.

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2.3.5. Warning labels on the analyzer

Label Meaning Explanation

Biohazard

Sample and waste are

potentially infectious

material

Corrosive

Reagents may cause

corrosion or skin irritation.

Warning General warning of injury.

Sharp

needle

warning

Sampling needle may

cause injury.

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3. MENU SYSTEM

3.1. General Information

This chapter contains information about the structure and usage of the software implemented menu structure.

This integrated software controls instrument operations including calculation and evaluation of measured data, displaying results and information screens, storage and recalling of data.

3.1.1. Navigating in the Menu System

The instrument uses a menu system to initiate actions and to access settings. Navigate in the menu system by simply touching the LCD at the item you want to

open/activate. From any submenu, the Home button will go back to Main menu, while Back moves one step back in the menu tree.

3.1.2. Touch screen calibration

In case you experience uncertainties during tapping the touch screen (you tap a specific location, still the required function key is not being activated) you will have to calibrate the touch panel.

Tap and gently hold any location on the touch screen. (Make sure not to press it hard, otherwise you can damage the screen.) After cca 10 seconds, a calibrating screen appears. Tap the reference points one after another. If you made an error, you will hear an error beep, and the process restarts.

If the calibration was successful, you will return to the original screen.

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3.1.3. Menu structure

Measure New

Re-run Blank Print Discard

Database Detail / Table view

Edit record Print Filter Trends Manage

Maintenance Cleaning Cleaning

Hard cleaning Drain chamber

Calibration Factors Measure History Pre-diluted Factors History

Quality control QC1 References QC2 Measure QC3 Diagram QC4 Database QC5 QC6

Diagnostics Device information Self test

Reagent status Volumes

Settings Printer Device

Format Header

General settings Measurement Units Normal ranges Profile Settings Result / Calibration

Date and time Set Date / Time Date Format

Exit Logout Add new user

Shut down Remove User Preparing for shipment Auto login set User Management Edit / View user

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When you have to enter data, an the on screen keyboard appears on the screen. It can be a numerical or alphanumeric keyboard, depending on the function.

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4. OPERATING PRINCIPLES

4.1. Impedance Method

The impedance method (a.k.a. Coulter-method) counts and sizes cells by detecting and measuring changes in electrical impedance when a particle in a conductive liquid passes through a small aperture.

Figure 7. Impedance method

Each cell passing through the aperture – there is a constant DC current flowing between the external and internal electrodes – causes some change in the impedance of the conductive blood cell suspension. These changes are recorded as increases in the voltage between the electrodes. The number of pulses is proportional to the number of particles. The intensity of each pulse is proportional to the volume of that particle. The volume distribution of the cells are displayed on diagrams: WBC, RBC, and PLT histograms.

4.2. Principle of HGB Measurement

The lysed sample dilution can be measured by a photometric method. The reagent lyses the red blood cells, which release hemoglobin. The chemical process forms a stable form of methemoglobin. This is measured by a photometer on the chamber.

All Erba Lachema branded reagents are cyanide free, and thus are environmentfriendly. However, some reagents from other manufacturers may contain cyanide. In that case, cyanide and any other chemical composition formed using cyanide is environmentally dangerous. Contact the reagent manufacturer for safety measures. The manufacturer (Erba Lachema s.r.o.) is not liable for any damage caused by using cyanide based reagents with any of its analyzers.

Blood cell suspension External electrode

Internal electrode Aperture

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4.3. Parameters

EELLiittee 33

measures and calculates 20 parameters, listed below. For each parameter we list the name, abbreviation and measurement unit in the first column. Short description for each parameter is in the second column.

White Blood Cells – WBC (cells/l, cells/µl)

Number of leukocytes WBC = WBC

cal

x counted WBC (cells/l, cells/µl)

Red Blood Cells – RBC (cells/l, cells/µl)

Number of erythrocytes RBC = RBC

cal

x counted RBC (cells/l, cells/µl)

Hemoglobin concentration - HGB

(g/dl, g/l, mmol/l)

Measured photometrically at 540 nm; in each cycle blank measurement is performed on diluent

HGB = HGB

cal

x (HGB

measured

– HGB

blank

)

Mean Corpuscular Volume - MCV (fl)

Average volume of individual erythrocytes derived from the RBC histogram.

Hematocrit – HCT

(percentage, absolute)

Calculated from the RBC and MCV values. HCT

percentage

= RBC x MCV x 100

HCT

absolute

= RBC x MCV

Mean Corpuscular Hemoglobin – MCH (pg, fmol)

Average hemoglobin content of erythrocytes, calculated from RBC and HGB values.

MCH = HGB / RBC

Mean Corpuscular Hemoglobin Concentration – MCHC

(g/dl, g/l, mmol/l)

Calculated from the HGB and HCT values. MCHC = HGB / HCT

absolute

Unit of measurement is displayed according to the one chosen for HGB result (g/dl, g/l or mmol/l)

Red Cell Distribution Width – RDW-SD (fl) Platelet Distribution Width – PDW-SD (fl) Red cell Distribution Width – RDW-CV (absolute) Platelet Distribution Width – PDW-CV (absolute)

The distribution width of the erythrocyte or platelet population derived from the histogram at 20% of peak

xDW-SD = RDW

cal

x (P2 - P1) (fl),

xDW-CV = RDW

cal

x 0.56 x (P2 - P1) / (P2 + P1)

by the factor of 0.56 CV is corrected to the 60% cut

Platelet – PLT (cells/l, cells/µl)

Number of thrombocytes (platelets) PLT = PLT

cal

x counted PLT (cells/l, cells/µl)

Mean Platelet Volume – MPV (fl)

Average volume of individual platelets derived from the PLT histogram

Thrombocrit – PCT (percentage, absolute)

Calculated from the PLT and MPV values PCT

percentage

= PLT x MPV x 100

PCT

absolute

= PLT x MPV

White blood cell 3-part differential:

LYM, LYM% : lymphocytes MON, MON% : monocytes and some

eosinophils GRA, GRA%: granulocytes

Absolute values counted in the channels determined by the three WBC discriminators:

Percentages calculated from the absolute WBC value.

GRA

LYM

1. 2.

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4.4. Absolute and Linearity Ranges of Parameters

The analyzer provides specified accuracy within its linearity range. Beyond this linearity range, the instrument can display results but accuracy is impaired.

If a value is over the maximum range of guaranteed linearity, the instrument cannot measure it and the result will be marked with an E (Error) flag.

To measure a sample, whose parameters exceed the maximum value indicated in the table below, pre-dilution is recommended. See section 5.2.7 of this manual.

Linearity ranges of primary parameters in normal measuring mode:

Parameter Linearity Ranges Maximum Unit

WBC

0...100 150 109 cells/liter

RBC

0...15 20 10

cells/liter

PLT

0...700 1000 109 cells/liter

HGB

0...250 400 g/l

HCT

0...100 - %

MCV

30...150 - fl

MPV

3...30 - fl

Table 2. Linearity ranges of parameters

Linearity ranges for 1:5 pre-dilution mode:

Parameter Linearity Ranges Maximum Unit

WBC

2…200 300 109 cells/liter

RBC

1…30 40 10

cells/liter

PLT

100…2000 3000 109 cells/liter

Table 3. Linearity ranges of Pre-dilution mode

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5. ROUTINE UTILIZATION and MEASUREMENT

5.1. Sample handling

Since some time will usually elapse between collection of samples and counting, it is necessary to preserve the sample with an anti-coagulant to prevent large groups of cells forming into clots or lumps of cell matter that will clog the cell counter. Choice of anti-coagulant is very important, as some anticoagulants will affect the shape and size of blood cells. In general K3-EDTA (liquid), preferably potassium based, is the only anti-coagulant recommended for use with electronic blood counters. Care must be taken when using homemade containers pre-dosed with EDTA. If the container is not filled with enough blood, the concentration of EDTA to blood may reach a level, which results in osmotic transfer from the RBCs which shrinks them. The concentration of EDTA to blood should not exceed 3 mg/ml. Generally, we suggest using pre-manufactured sample tubes containing the necessary amount of EDTA. Also, when taking blood, please make sure that requirements attached to sample tubes are met.

Important

! Make sure to fill sample tubes to at least 7-8 mm height with blood

otherwise correct sampling cannot be guaranteed! Observe marking on sample tube.

There is another possibility that can help the user to help the analyzer get a reliable sample from the tube: using the needle setting function. This is available in Measurement Local menu, and controls sampling height of the needle inside the sample tube. If you have a sample tube with a higher/lower bottom, you can control the sampling height adjusting this option. This can also help if sample level is too low within a sampling tube. Needle offset is displayed in the lower left corner of the measurement screen.

Attention! If you hurt yourself during analysis, biohazard substances can cause infection! Always take special care to sharp objects and always use rubber gloves!

To initiate analysis:

1. Invert the closed sample tube at least 8 times to achieve a homogenous sample. Do not shake the sample, because micro-bubbles can form inside which may cause erroneous sampling!

You have the possibility to use 3 different interchangeable adapters for different tube types. Tube types are shown in the next pictures:

• Vacutainer tube adapter for 3-5 ml sample tubes

• Micro adapter for micro-tainers

• Control adapter for 2 ml blood control vial

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Vacutainer with sample blood (cap removed)

Sample tube with 5 ml control blood

Figure 8. Tubes used in Vacutainer ® adapter

Below you can see 3 types of microtainer tubes used in micro adapter. These are only examples given by us, you can try to use other type of microtainers as well.

There must be at least 8 mm

sample level for safe

sampling

Be careful to place the tube with

the cap always in the position

shown above, otherwise the cap

can get stuck when the sample

holder turns.

Figure 9. Tubes used in micro adapter

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Adapter for 2 ml control blood

Figure 10. Vial used in control adapter

1. Remove the cap!! It is very important because the tip can not pierce the cap!

2. Position the sample tube in the sample rotor.

3. Press START key.

The sample rotor will turn the vial into the inside of the instrument and needle draws sample from the tube. The aspirating needle is retracted, while its outer surface is automatically rinsed with diluent by needle wash head. This insures the low carryover between samples. After a few seconds, the rotor turns out. Now you can remove the sample tube from the adapter.

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5.2. Sample analysis

5.2.1. Sample preparation

Use K3-EDTA anti-coagulated fresh whole blood as sample. Prior to sampling, mix the sample gently by inverting it at least 8 times. Do not shake as this could damage blood cells and create micro-bubbles that cause sampling error.

5.2.2. Running a (new) sample

MEASURE This is the screen where you can start

measurements. Exit will return to the Main menu

Press New to enter data for the sample. Software allows the user to enter information for every sample. If an external PC

keyboard (via USB) is used, connect it before turning the instrument on.

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There are two options to enter sample information:

• immediately before analysis

• in Database menu

To enter sample information prior to sample analysis, touch sample info field in the MEASURE screen. The following screen appears:

MEASURE New Sample ID

A screen appears

offering data entry for

the upcoming sample. Sample ID can be defined to identify the

sample

Type offers a list of profiles to select from Doctor will appear on the printout as well Cancel will return to the measurement

screen (above).

MEASURE New Patient ID

A screen appears

offering data entry for

the patient.

Cancel will return to the measurement screen.

MEASURE New Options

A screen appears where

offering data

entry for the upcoming sample. Settings remain as they are set for the

following samples as well. Cancel will return to the sample info

screen.

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Pre-diluted mode offers two options: Yes or No. If you set it to Yes, then the instruments expects a pre-diluted sample (with a ratio of 1:5 – 1 unit of sample and 5 units of isotonic saline solution – the total volume should be minimum 1ml) WBC only offers two options: Yes or No. If you set it to Yes, then the instrument will not measure and display RBC and PLT related parameters. You’ll receive a total WBC count with 3part results and HGB reading (WBC, LYM, MON, GRA, LYM%, MON%, GRA%, HGB)

Change lyse

Volume of lyse reagent added to MIX dilution controls performance of WBC 3-part differential. Default lyse setting for each sample type (Human, control, Child, etc.) are specified by SW. Default lyse quantity can be adjusted in Patient limits menu (Settings / Measurement Limits)

Select an increased (+0.1, +0.2ml) volume if the separation between lysed RBCs and WBC populations is poorly differentiated, resulting in increased WBC and LYM counts. Select a decreased (-0.1, -0.2ml) volume if the WBC histogram seems to be shrunk to the left, i.e. the different WBC populations are overlapped. This can inhibit proper separation of WBC populations.

MEASURE New Options / Lyse volume Change lyse These are the + or – options you can select from. See above description for information.

Sampling depth

The analyzer requires a minimum of 2ml of whole blood in the sampling tube. ELite 3 can however be adjusted for low volume samples. This becomes necessary when there is extremely low volume of sample in the tube. This option also allows using sampling tubes with an elevated bottom. In this case you have to set a higher sampling level to avoid the needle hitting the bottom of the tube.

MEASURE New Options / Sampling depth

Select the necessary option so that the instrument can take sample from the right location.

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When all parameters are set, press the START button to save your settings and start the measurement.

WARNING! Do not reach inside the instrument during operation,

as the needle can injure you!

5.2.3. Results

When analysis is complete, the following screen is displayed, including all measured and calculated parameters as well as the WBC, RBC, and PLT histograms. Results, histograms and other data will be stored automatically in the memory.

To look at histograms in detail, tap the arrows to see further details.

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5.2.4. Warning flags

Analyzer SW displays warning flags for each individual measurement to notify user about status of results. The following table summarizes warning flags and gives explanation of their possible cause and a few hints to overcome the problem.

Flag Meaning Recommended user action

No WBC 3-part differential

Possible lyse problem. May occur in pathological lymphocytosis.

HGB blank is high, or no HGB blank

Repeat the blank measurement. If HGB blank is not stable there are probably bubbles in the WBC chamber: Run a cleaning and try blank again. Close the side door if open during measurement.

WBC blank is high, or no WBC blank

Repeat the blank measurement, or run prime lyse and try blank again. Possible lyse contamination, or noise problem.

linearity range exceeded in WBC stage

The analyzer found that the cell count is higher than the linearity range of the analyzer. Make a pre-dilution, and run the same sample in pre-diluted mode

RBC cells found in sample during WBC stage

RBC cells were detected during the WBC measurement. Either the lyse reagent is not effective enough (volume should be increased) or the RBC’s in the sample are somewhat lyse resistive

WBC 3-part warning

Probably large PLTs or clumped PLTs are present in the sample. Usually caused by the nature of the sample. cat and goat samples tend to clump. Intensive, but careful mixing of the sample (e.g. Vortex) can help remove the clumps. If the rerun sample gives the same results, consider that WBC and NEU values seem higher because of the clumps. Lyse modification can’t solve the problem.

RBC-WBC limit warning

Typically insufficiently lysed RBC’s interfere with the start of the WBC histogram. Repeating the measurement with an increased lyse volume should provide better separation. If the repeated run reports very similar results then the MON and NEU results are VALID but the WBC and LYM results may be higher because of interfering RBCs.

WBC clogging

Aperture clogging. Perform cleaning and repeat the measurement. If it is a general problem, please contact your Service Personnel.

Low temperature reagents can cause it as well (mainly diluent), in this case you will have to wait until they reach room temperature.

Table 4. Summary of warning flags related to WBC/HGB

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Warning flags in lowercase refer to RBC or PLT problems.

Flag Meaning Recommended user action

linearity range exceeded in PLT/RBC stage

The analyzer found that the cell count is higher than the linearity range of the analyzer. Make a predilution, and run the same sample in pre-diluted mode

RBC peak error

Multiple or incorrect RBC peak(s) detected. Try to run the sample again.

PLT / RBC limit not correct

PLT and RBC cells could not be separated, or the histogram remained high in the PLT/RBC valley range.

RBC/PLT clogging

The same action as in case of the C warning flag.

PLT blank is high, or no PLT blank

Run cleaning and repeat the blank measurement. Diluent or system cleanliness problem. If it is stable high, replace the

diluent by opening a new tank.

RBC blank is high, or no RBC blank

Same action as in case of warning flag p.

Table 5. Summary of warning flags related to RBC/PLT

Measurement conditions: when the flags are related to clogging (c, C), probably hemolysing problems (E). Try to repeat the measurement.

The exclamation mark flag (!) near a parameter shows some doubt during the evaluation of that parameter.

The reasons can be: a high PLT blank (PLT value will be marked), a case of indefinite discriminator setting (default location is used for some reasons, related parameters will be marked), etc.

Another flagging method is evaluation against the normal ranges. If some of the parameters is out of range it gets a (-) flag if under the range, or gets (+) if over the range. (And the given parameter will be highlighted as well.) You can customize ranges for all kind of patients by setting the corresponding lower and upper ranges. If you set 0 for a range limit, it will be not verified.

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5.2.5. Parameter Limits (Normal ranges)

Limits define normal ranges. Outside this range, parameters will be flagged: – or +.

Settings Measurement Normal ranges The “Human” (profile) button brings up the

profile selection menu Prev and Next allow browsing among

parameters. Parameter order: WBC RBC HGB HCT

MCV MCH MCHC PLT PCT MPV PDWs PDWc RDWs RDWc LYM MID GRA LYM% MID% GRA%

You can modify normal range of parameters: left column is lower, right column is upper limit of normal range. Press Accept to accept changes, or Cancel to keep previous settings and return to the settings menu.

5.2.6. Blank Measurement

The system uses blank measurements to check cleanliness of the system and reagents. Run a Blank measurement:

• Daily once, before sample analysis

• After any reagent change (activated manually from MEASURE / MEASURE

BLANK menu).

• After the replacement of any hardware component that is closely related to the

measuring process (aspiration, dilution, counting, rinsing).

In MEASURE mode press the Blank button. If Blank measurement was not acceptable, press DISCARD to discard blank result or repeat Blank measurement until the results are acceptable. The analyzer is ready for sample analysis, and displays an empty sample measurement screen.

There are 3 regions for blank value handling:

1. Optimal – all results are within acceptable ranges.

2. Blank is high – ! flag displayed at relevant results.

3. Blank exceeds acceptability – no results displayed.

Parameter 1. No flag at parameter

2. ! flag at result 3. E (error) flag at result HGB 0-10 g/l 10 - 25 g/l > 25 g/l WBC 0 - 0.5 x103 cells/µl 0.5 - 1.0 x103 cells/µl > 1.0 x103 cells/µl

PLT 0 - 25 x103 cells/µl 25 - 50 x103 cells/µl > 50 x103 cells/µl

RBC 0 - 0.05 x106 cells/µl 0.05 - 0.5 x106 cells/µl

> 0.5 x106 cells/µl

Table 6. Blank measurement ranges

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Accepted blank values are essential for proper calibration. Perform calibration only if all blank values came in the first region (no flags or errors).

If analysis errors occur or blank measurement is too high, an E error flag appears along with the affected parameter and “---“ is displayed instead of results. In this situation, perform a cleaning (see Section 7.1.).

5.2.7. Using Pre-diluted Mode

Pre-diluted measurement mode allows to measure insufficient sample for normal mode, or if some parameter is out of the linearity range (WBC = 300 x 103 cells/µl).

Perform an external pre-dilution of the sample using clean isotonic saline solution, or diluent reagent. Dilute the sample to 1:5 ratio (1 part sample to 5 part diluent), using a clean sample vial. Mix it well.

To perform the analysis on a pre-diluted sample:

1. In Main menu select Measure

2. New

3. In Options, select Pre-diluted mode

4. Put pre-diluted sample into the sample adapter

5. Press START button. The analyzer will automatically calculate the results with the 1:5 pre-dilution factor.

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6. DATABASE

Patient results are stored in the memory in chronological order, and can be retrieved at any time. Data storing capacity is 1000 measurements, including the complete parameter list, histograms, flags, sample data, and date/time of measurements. If memory is full, newest (actual) record will overwrite oldest record.

Select Database to access records stored in the memory of the analyzer. The first screen that appears shows the most recent saved results.

DATABASE Left and right arrows access remaining, non-

visible parameter results, up and down arrows scroll among records individually.

Menu key opens up local menu for accessing further functions (see below).

Exit key returns to MAIN menu.

Each line starts with a checkbox and the Sample ID displayed. A filled checkbox indicates that a specific record is selected for further operations.

The bottom row of the screen shows the status line. This line provides information about the number of records stored in the database and the number of records selected.

As it can be seen on the screen, some buttons are not active (Print, Trends, Manage). They become active when at least one record is selected.

Detail will open up detailed data (parameters, histograms, flags) of the record at the top of the list.

Print will send the result to the selected printer (USB or internal) Filter offers tools to select records from the database. You can select based on

Sample ID, Patient ID, measurement time stamp, sample type. Trends offers a statistical tool to monitor variation of parameter values. It is an ideal

tool to track variation of parameters of a specific patient with time. Manage opens up a menu where data can be deleted, archived or transmitted to a

computer. Exit returns to the main menu.

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6.1. Database services

Detail will open up the parameter and histogram view of a record.

DATABASE Detail

Print sends the record to the printer. Edit opens up the dialog for data

manipulation of the record Back returns to the Main menu

DATABASE Detail Edit When looking at record from the database

view, some fields are not editable (Sample ID, sample type). These can only be set before running the sample. Patient ID tab allows entering further data.

DATABASE Detail PID This option allows editing patient

information. When you push the ACCEPT button, your changes will be saved.

The Sample ID tab returns to the Sample ID screen (above).

Patient ID can be 32 characters long and the name of the patient can hold 40 characters.

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DATABASE Detail Arrows Te database record view allows browsing in

the database, and you can also look at histograms and various diagnostic parameters of the sample.

The arrows in the sample data field (indicated with BLUE marks) allow browsing in the database. Tapping them brings up the next or the previous record in the database. The arrows marked with GREEN color allow looking at various panels of the result.

Diagnostic flags Parameter view WBC histogram RBC histogram

6.2. The Filter / Select function

DATABASE Filter Date allows defining the start and end dates

for the search. Sample ID and Patient ID can narrow the

search. If you enter “5” for sample id, then all records, whose Sample ID contains the expression (“5” in our case) will be selected (5, 15, 451, etc..)

Using Type you can further narrow the list of samples. With Records you can define to use All or already selected results for the search.

Clear will reset all fields. Select will return to the table view, and will fill the checkboxes of records matching

the criteria. Filter will also return to the table view, but only records matching the criteria will be shown. The status bar of the table view will show: “Filter on”.

NOTE There is an AND relation between the fields. If you fill in more than

one field, then you can narrow the search: e.g. measured between

2009/08/10 and 2009/09/20 AND having a sample ID “1221”

UP / DN

Histograms

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6.3. Printing records

DATABASE Print

If there is no record selected, then the software prints the actual (top / detail view) record.

If there is more than 1 record selected, then you will be able to choose between individual printing (Result by result), or

Table format format if external USB printer is set.

Using built-in printer only the result-by-result printing is available.

Abort, Cancel aborts the operation.

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6.4. Manage records

The Manage button becomes active if there is more than 1 record selected in the database. Pressing Manage brings up the following screen:

DATABASE Manage

Back aborts the operation and returns to the table view.

Deselect will clear the checkboxes of all selected records. Send will transmit record(s) to a connected computer. A progress bar shows the

status of the process. Delete will permanently delete selected record(s) from the database. You have to

confirm this operation. Backup will save selected record(s) to an external USB memory device. A progress

bar shows the status of the process.

NOTE Do not remove the USB memory device as long as its status LED

is blinking, because it can cause data loss on the memory device.

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7. MAINTENANCE

In the Maintenance menu you can initiate procedures, for cleaning, calibration or specific performance analysis.

Maintenance

Touch menu item of the desired function.

Home will return to the Main menu Back returns to the previous level.

7.1. Cleaning

Cleaning functions allow cleaning of fluidics to reduce blank value by removing contamination from tubing, chamber and valves.

Maintenance Cleaning

Press HOME to go to Main menu. Press BACK to go back to previous menu.

Cleaning starts a washing cycle using the system cleaner reagent connected to the analyzer. This action is recommended if clogging problems are experienced (C or Q error flag), or the blank is high. Hard cleaning initiates a process that uses a light solution of Erba Hypocleaner CC, and washes the sampling needle and related tubing with it. The instrument will ask for the cleaning solution in a sampling tube.

Drain chamber will empty the measurement chamber. You can use this option to manually add cleaning solution to the chamber when necessary (extreme contamination in the chamber).

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7.2. Calibration

The analyzer stability can be monitored with Erba Hematology Control - control blood. Performing QC determinations regularly verifies continued optimal performance.

It is recommended to do calibration in the following cases:

1. At analyzer installation, before beginning the analyses.

2. After replacing any component, related to the process of dilution or measurement.

3. When quality control measurements show any systematic error (bias) or they are outside predefined limits.

4. At regular time intervals (determined by the lab itself).

5. If you want to use the instrument in Pre-diluted mode (separate pre-diluted calibration factors are available).

Calibration can be performed in two ways:

1. User can enter calibration factors – without any calibration measurements – using the numerical keypad.

2. 1, 2, 3 or more measurements of control blood or calibrator, with known parameters. In this case, the instrument automatically calculates new factors using the following formula:

New factor =

Assigned value x Stored factor

Measured value(s) (or average of those)

CAUTION! New calibration will invalidate the previous factors.

Old values can be checked at Calibration History.

Maintenance Calibration

You can select the following functions: Factors: enter calibration coefficients manually Measure: define target values and start calibration measurements

History: display past calibration factors. Pre-diluted: calibration Factors and

History for pre-diluted measurements.

Press HOME to go to Main menu. Press BACK to go back to previous menu.

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7.2.1. Calibration with factors

Factor based calibration allows adjustment of primary parameters with a factor.

Maintenance Calibration / Factors

Press white data field to modify calibration factor. A numeric input screen will show up so that you can enter values.

All values must be in the 0

.8…1.2 range.

Press Accept to proceed with new settings, or Cancel to keep values unchanged.

7.2.2. Calibration by measurement

The analyzer can run calibrator, and perform calculation of factors automatically. User can decide the number of measurements to use for calibration.

Maintenance Calibration / Measurement

Prior to starting the calibration measurements, you have to define some basic parameters for the upcoming measurements.

As the next step, target values from the assay sheet of the calibrator or control must be entered before measurement.

Maintenance Calibration / Measurement

Prior to starting the calibration measurements, you have to define some basic parameters for the upcoming measurements.

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Target values for calibrated parameters can be set within the following ranges:

Parameter

Low limit

High limit

WBC 1.0 30.0

RBC 1.00 8.00

HGB g/l 30 300

MCV 50 120

RDW CV 10 50

PLT 30 800

MPV 5 15

PDW CV 5 50

HCT 0.1 0.6

PCT 0 2

Table 7. Calibration target ranges

When all parameters are set, press Accept key.

The display shows Calibration measurement at top.

Maintenance Calibration / Measurement

Insert the sample tube to the sample door and press the START button.

Exit will abort the operation.

Calibration runs are saved automatically. If you find that a result should not be used, use the Discard button to delete the measurement so that it is not used for calibration.

Maintenance Calibration / Measurement / Result

Result will display the average of each parameter of accepted measurements compared to the target value and the calibration factor calculated.

Accept saves new factors and aborts calibration Back will return to the calibration measurement screen so that you can measure more samples for calibration.

You can compare target and measured values, observe CV and see how the calibration factor would change. Maintenance

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Calibration / History

You can check the date and values of previous calibrations.

7.3. Quality control

Quality control feature allows tracing the operation and reliability of the analyzer in time. The best practice is to run a control sample every morning. You can also use multiple control material lots.

Maintenance Quality control

Select LOT to work on.

Press HOME to go to Main menu. Press BACK to go back to previous menu.

Maintenance Diagnostics / QC1

Press HOME to go to Main menu. Press BACK to go back to previous menu.

Control material is a defined and controlled quality prepared (almost artificial) blood product. It has conserved and treated blood cells inside which allows this material to be stable for a much longer time than normal blood would be. The “Measure” option will become active only if there are reference values entered for the actual QC Lot.

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7.3.1. References

To be able to run specific samples, and to see stability or variation of parameters, it is necessary to define a reference material for the software. This is going to be the basis for Quality Control. The idea is to enter these so-called expected or target values, and save everyday repeated runs of the same material in a separate database so that these values can be compared to the reference data. Reference values arrive with the control material. The manufacturer recommends using Erba Hematology Control with the analyzer. The assay value sheet contains all necessary parameters for the control material.

Maintenance Quality control / Reference

Use Prev and Next to browse among parameters.

Press Accept to save data. Press Cancel to discard changes and return

to the previous menu.

Enter the values as defined on the assay value sheet of the control material. In case you want to omit the trend analysis of a parameters, define 0 (zero) as target and range values.

7.3.2. Measure

This option puts you to the measurement screen and sets up the parameters for Control Blood measurement. Put the sample in the sample holder and press the START button. When analysis is complete, you will have to accept the results.

Maintenance Quality control / Measure

The software saves all results automatically to the selected QC lot database.

Press Discard to remove data from QC series.

Exit returns to the QC menu

7.3.3. Diagram

QC Diagram displays the trends of parameters with respect to time. The screen will show two parameters at a time.

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Maintenance Quality control / Diagram

Use Up and Down shaded arrows to browse among parameters on both sides.

Press Exit to return to the previous menu.

This mode allows comparing tendencies, trends of any two parameters.

7.3.4. Database

This option displays the contents of the QC database. You can browse in this view just like in the regular database view. Functions (selection, browsing, details, printing) are the same as well.

Maintenance Quality control / Database

Use Prev and Next to browse among parameters.

Exit returns to the QC menu.

Note: QC database is a filtered view of the normal database. The status bar shows the “Filter on” text.

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8. Diagnostics

Diagnostics menu allows access to system information and hardware check-up.

Maintenance Diagnostics

Press HOME to go to Main menu. Press BACK to go back to previous menu.

8.1.1. Device Information

Device information shows system hardware and software setup.

Maintenance Diagnostics / Device Information The various system parameters can be seen

on the screen.

Press EXIT to go back to the previous menu.

8.1.2. Self Test

Self test is a procedure to verify proper operation of essential components of the instrument. Self test should be performed:

• At installation.

• After replacing any component.

• After extended time out of use.

During self test, the analyzer checks system components, and displays the results. On the right side of the results screen, the SW displays if the tested parameter falls into the desired range:

• If yes, a sign is displayed at the end of the line, or

• if it is out of range: a sign appears.

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8.2. Reagent status

The screen shows reagent volumes in containers, as calculated by the instrument. With each measurement, the volumes are changing accordingly. When reagent volume in a container is running low, instrument will notify user, and ask for replacement.

MAINTENANCE REAGENT STATUS Bar graphs show reagent status. Reset will reset reagent level to its full value. If any of the reagents is replaced (Reset),

press Prime to aspirate liquid into the system Volume opens up the container volume setup

screen.

If Waste is high, it should be disposed of properly (see next section for instructions).

MAINTENANCE REAGENT STATUS Volume Set the volume of the containers used.

Values in ml. If volume of a reagent is set to 0 (zero), software will not keep track of consumption.

Accept saves your changes. Cancel discards changes and returns to reagent status screen

DIAGNOSTICS SELF TEST The analyzer lists and checks subsystems. When tests are finished, display shows a

summary of the results. Various system parameters can be seen on the screen.

Press START to run Self test again. Press BACK to go back to previous menu.

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8.2.1. How to empty waste container

Software counts volume of waste, and gives warning message when the waste tank is close to its maximum capacity.

Empty the waste tank when this warning message appears. See next Section for neutralization steps.

8.2.2. Neutralization of Waste

Waste contains human origin substances representing biohazard. These substances are representing potential danger to environment. For this reason, safe handling of the waste liquid is very important

Neutralization of biohazard waste:

•

Put 2 ml per liter of hypochlorite solution into the waste. Close the cap and shake the container.

•

After 1 hour you can dispose of the Waste liquid into the drain.

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9. Settings

Selecting Settings accesses various lists of options

9.1. Printer settings

Printer settings menu allows setting up parameters of report printing.

Settings

Press BACK to go back to MAIN menu.

Settings Printer settings

Settings Printer settings / Device

Printer: Selection between built-in or USB printer. If the printer is recognized, the screen will show the printer’s name.

Format: Selects printout quality. Press Accept to approve changes made. Press Cancel to go back to previous menu

keeping the old settings.

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Limits: Enable / Disable parameter limit (normal range) printing. Warnings: If Enabled, warning flags appear on the report as well. Histograms: Enable / Disable graph printing. Technical information: If Enabled, probe voltages (WBC,RBC), lyse volume, (ml)

and software/firmware version appear in the printout. Diagnostic flags: If Enabled the diagnostic flags appear on the report as well (except table format)

Settings Printer / Device / Mode

Fast modes save ink and provide faster printout. Only normal color and fast color printouts will give color printouts.

SETTINGS Printer settings / Format

Press Accept to approve changes made. Press Cancel to go back to previous menu

keeping the old settings.

Settings Printer settings / Header The data entered will be printed on the top of

each printed report.

Press Accept to approve changes made. Press Cancel to go back to previous menu

keeping the old settings.

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9.2. General settings

General settings control operation of the following functions.

Export format: The following settings are available (See Appendix A for details):

•

Simple text

•

Extended text

•

Advances text Press Accept to approve changes made. Press Cancel to go back to previous menu keeping the old settings.

9.3. Measurement

SETTINGS General Sound: If enabled the analyzer provide

audible guidance of usage. Language: Selects the language of the

analyzer

Press Accept to approve changes made. Press Exit to go back to previous menu.

This section groups measurement related options and settings.

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9.3.1. Unit settings

Unit settings menu allows to set up units of parameters displayed or printed.

Possible units for the parameters:

Parameter Available units

Count unit

cells/liter(cells/l) cells/μl(cells/μl)

HGB unit

grams/liter (g/l) grams/deciliter (g/dl) millimols/liter (mmol/l)

PCT, HCT unit

Percentage (%), absolute(ABS)

RDW, PDW mode

standard deviation (SD), coefficient of variation(CV)

9.3.2. Normal ranges

Limits define normal ranges. Outside this range, parameters will be flagged: – or +.

Settings Measurement Normal ranges The “Human” (profile) button brings up the

profile selection menu Prev and Next allow browsing among

parameters. Parameter order: WBC RBC HGB HCT

MCV MCH MCHC PLT PCT MPV PDWs PDWc RDWs RDWc LYM MON GRA LYM% MON% GRA%

Settings Measurement / Units

Press units to change them individually Press Accept to approve changes made. Press Cancel to go back to previous menu

keeping the old units.

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9.3.3. Profile

Settings Measurement Profile

The default lyse volume can be set for each profile.

9.3.4. Settings

Settings Measurement / Settings/Result Auto print will print the report automatically

when the results are displayed Auto send will automatically transmit

results if a PC is connected Barcode allows setting scanned data to be

entered as Sample ID or Patient ID

Accept saves changes made Cancel returns to previous menu discarding

changes made Settings Measurement / Settings/Calibration Mode allows choosing between HCT/PCT

or MCV/MPV based calibration

Accept saves changes made Cancel returns to previous menu discarding

changes made

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9.4. Date and Time

Date and time of each analysis is stored with the results. This menu allows setting the built-in clock and the format of the date displayed.

The analyzer has a built-in battery responsible for running the built-in clock when the unit is powered off. If the analyzer asks for date and time setting after power on, then this battery is having problems. To resolve the problem, contact Service.

Settings Date and time

Type in the date and time. Select formats for displaying the date.

Press Accept to save settings. Press Cancel to go back to previous menu

keeping the old values.

Type in the date and time. Press Accept to save settings.

Press Cancel to go back to previous menu keeping the old values.

Select formats for displaying the date. Press Accept to save settings.

Press Cancel to go back to previous menu keeping the old values.

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9.5. Multi user mode

The analyzer allows operation in a multi-user environment, where users can have different rights and access levels. This feature is accessed upon startup, and can of course be customized. The analyzer by deafult operates in a multi-user environment – however the user should not notice this functionality.

Users can be added (Add New User) or edited (Edit / View User). Adding a user allows filling in the below parameters. Password must be defined on “Advanced Info” tab. Monogram will be displayed on the login screen.

Use Remove User option to disable its access.

Exit

Logout will leave the unit on, and the login screen appears.

Multi user mode functionality can be enabled in the Exit menu by adding users in User Management.

Exit User Management

Auto Login Set will allow login-free starting of the analyzer.

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NOTE

User Admin cannot be deleted. Admin password cannot be changed. Admin password: 0000

User Type BASIC has limited access to the menu tree:

Measure New Options

Re-run Blank Print Discard

Database Detail / Table view

Edit record Print Filter Trends Manage

Maintenance Cleaning Cleaning

Hard cleaning Drain chamber

Calibration Factors Measure History Pre-diluted Factors History Quality control (forbidden)

Diagnostics Device information Self test Service

Reagent status

(Settings forbidden)

Exit Logout Add new user

Shut down Remove User Preparing for shipment Auto login set User Management Edit / View user

Exit User Management Auto Login Set

Auto Login Set will allow login-free starting of the analyzer. Select the user to be logged in automatically. With Auto Login Off selected, the instrument will prompt for a user and a password upon startup.

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Use Shutdown to stop the analyzer (power off)

Preparing for shipment will drain the unit so that it can be transported.

Touch Login name. Select name from list. Enter password.

Instrument will show database upon correct password entry.

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10. PRINTING

This chapter covers information on making printed reports on measured samples.

10.1. Printouts

When required, the following items can be sent to an external printer or to the built-in printer by selecting Print option.

* Database result(s) (table format) * Database (specified patient results with histograms) * QC result (Levey-Jennings chart) * QC result(s) (table format) * Calibration results * Last measured blank result * Last measured patient result (with histograms) * Last measured QC result * Device information and statistics * Self test result * Set parameters * Diagnostic flags (optional)

Thermal paper printout Printout on external printer

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Database Table Printout

QC graphical printout on built-in printer QC graphical printout on external printer

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11. Troubleshooting

11.1. Regular Troubleshooting Procedures

From Troubleshooting submenu, user can initiate maintenance procedures such as blank measurement, cleaning, priming, or draining chamber.

For details on Blank measurement, see Section 5.2.6.

11.2. Weekly User Maintenance

Perform weekly maintenance before turning on the power switch. The right side has a side door giving access to the fluidic system and the mechanical parts easily.

11.2.1. Cleaning needle washing head

Needle washing head cleans the outer surface of the aspirating needle with diluent. Any salt build-up on the lower surface may cause malfunction during operation. Use

a soft cloth or wiper dampened with water to clean this area. You can see the washing head indicated in the following figure:

Figure 12. Parts of measuring block

1. Exit Measure menu. Open the side door after the needle has stopped moving.

2. Gently rub the lower surface of the washing head with a damp cloth or wiper to

remove the salt build-up.

3. Close the side door.

Washing head

Measuring

chambers

Measuring

apertures

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12. Fluidic Schematics

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13. Reagent consumption

Function

Reagent consumption / function (ml)

Diluent Lyse Cleaner

Startup (init + wake up) 200 5 7 Shut down 37 0 6 Measure Blank 34 1 0 Measure Human 34 1 0 Measure Calibration 34 1 0 Measure QC 34 1 0 Prime Diluent 29 0 0 Prime Lyse 26 2 0 Prime Cleaner 31 0 2 Standby 13 0 0 Wake up 9 0 0 Clean 41 0 5 Hard clean 51 0 0 Selftest 16 0 0

Preparing for shipment: rinse 80 ml Hard clean: cleaning solution 0,7 ml

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14. Appendix A

To save in text format (tab separated values) use the Export function in Database menu. To process the results in Microsoft Excel import the text files into Excel worksheets.

Note: The text format files do not contain all the information available in binary format files.

The following 3 text file format is available:

HT means Horizontal Tabulator Character in the following descriptions:

A. Simple text

B. Extended text

C. Advanced text

- WBC ill. RBC histogram 256 pieces numbers between 0 and 255 separated by HT

character

- <WBC marker 1> WBC low marker

- <WBC marker 2> LYM-MON marker

- <WBC marker 3> MON-GRA marker

- <RBC marker 1> PLT-RBC marker

- The marker value is a number between 0..255 gives the index of the related value in the

WBC/RBC histogram data set.

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15. Contact

For customer and technical support: Manufacturer:

Erba Lachema s.r.o., Karásek 2219/1d, 621 00 Brno Czech Republic Tel: +420 517 077 111 e-mail: [email protected] Website : https://www.erbamannheim.com/en/product-support/

Contact your local technical support: (Print this page and write or paste contact

information for easy access)

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16. Appendix- package inserts for reagents and

cleaning solutions

Revision 3.0

Date of Revision 07/2017

HEMA/PI/14/17/B

Page 73

Erba Lachema s.r.o., Karásek 2219/1d, 621 00 Brno, CZ e-mail: [email protected], www.erbalachema.com

Erba Diluent-Diff

Diluent for automated analyzers

Name Cat. No. Package volume

Erba Diluent-Di󰀨

HEM00004 20 L

For in vitro diagnostic use only

INTENDED USE

Erba Diluent-Di󰀨 is a bu󰀨ered, stabilized and micro-ltered electrolyte solution for automated dilution of human blood samples, quantitative and qualitative determination of erythrocytes (RBC), leucocytes (WBC) and the leucocyte subpopulations, thrombocytes (PLT) and measurement of hemoglobin (HGB) concentration on hematology analyzers. Erba Diluent-Di󰀨 should be used with only Erba Lachema reagents. Erroneous results may be obtained if the reagent is applied with third party reagents. Please refer to the instrument’s User Manual for further information.

INGREDIENTS

Sodium chloride < 1.5 % Bu󰀨ers < 1.0 % Preservative < 0.5 % Stabilizers < 0.5 % in ion-free water

HANDLING PRECAUTIONS

- Erba Diluent-Di󰀨 is environmental friendly, azide-free reagent; does not contain harmful ingredients.

- Avoid contact with eyes, skin and clothing.

- In case of eye or skin contact ush eyes with copious amounts of water for several minutes or wash skin area with water.

- Keep the reagent container closed when not in use.

- Wear laboratory gloves when handling the reagent.

- All body uid samples should be considered potentially infectious materials. Treat all blood and other potentially infectious materials with appropriate precautions. Use gloves, masks and gowns if blood exposure is anticipated.

- Use Good Laboratory Practices (GLP) when handling the reagents.

SPECIMEN COLLECTION AND PREPARATION

Erba Diluent-Di󰀨 is intended for use with blood specimens collected by vein puncture in EDTA anticoagulant. Specimens for hematological analysis may be stored for up to 8 hours at (+15 to +30) ºC or up to 24 hours after collection when refrigerated (+2 to +8) ºC.

REAGENT PREPARATION

- This reagent is ready for use and can be applied straight from the container; no special reagent preparation is necessary.

- Leave the reagent at room temperature for at least 12 hours.

REAGENT REPLACEMENT

- Person installing the reagent must be a trained laboratory professional.

- Remove the inlet cap from the reagent container to be replaced. Connect the reagent inlet to the new reagent container.

- Be sure that the colour on each tube, reagent container label and connector in the back of the instrument match.

- Avoid any dust or microbial contamination of the tubing and reagents.

- Prime thoroughly the new reagent and measure backgrounds according to the instrument’s User Manual.

- When installing a new lot of reagent, recalibrate the instrument as specied in your User Manual.

REAGENT STORAGE, STABILITY AND DISPOSAL

- Store Erba Diluent-Di󰀨 diluent between +15 and +30°C.

- The shelf life of the Erba Diluent-Di󰀨 diluent is 36 months from date of manufacture, if stored at the prescribed temperature range.

- Do not use reagent beyond the expiration date printed on the container label.

- Discard opened container after 120 days.

- Do not use reagent once frozen.

- Dispose of waste product, unused product and contaminated packaging in compliance with local regulations.

IVD

Hematology reagents

HEMA/PI/10/17/B Date of revision: 25. 7. 2017

See Instruction for Use

Catalogue Number Lot Number

Expiry date

In vitro Diagnostics

Storage Temperature

Content

CONT

Manufacturer

REF

CE Mark Device comply with the Directive 98/79/EC

USED SYMBOLS

IVD

50003763

Page 74

Erba Lachema s.r.o., Karásek 2219/1d, 621 00 Brno, CZ e-mail: [email protected], www.erbalachema.com

Erba Lyse-Diff

Lysing reagent for automated analyzers

Name Cat. No. Package volume

Erba Lyse-Di󰀨 HEM00007 (opened) 1 L

Erba Lyse-Di󰀨 HEM00008 (closed) 1 L

For in vitro diagnostic use only

INTENDED USE

Erba Lyse-Di󰀨 lysing reagent is a stabilized and micro-ltered lysing agent for stromatolysis of erythtrocytes (RBC), for quantitative determination of leukocytes (WBC), leukocyte three-part di󰀨erentiation (LYM, MID, GRAN) and hemoglobin (HGB) concentration measurement in human blood on hematology analyzer. Erba Lyse-Di󰀨 lysing reagent should be used with only Erba Lachema reagents. Erroneous results may be obtained if the reagent is applied with third party reagents. Please refer to the instrument’s User Manual for further information.

INGREDIENTS

Surfactants < 3.5 % Bu󰀨ers < 1.0 % Preservative < 0.5 % Stabilizers < 0.5 % in ion-free water

HANDLING PRECAUTIONS

- Erba Lyse-Di󰀨 lysing reagent is environmental friendly, cyanide-free and azide-free reagent; does not contain harmful ingredients.

- Avoid contact with eyes, skin and clothing.

- In case of eye or skin contact ush eyes with copious amounts of water for several minutes or wash skin area with water.

- Keep the reagent container closed when not in use.

- Wear laboratory gloves when handling the reagent.

- Use Good Laboratory Practices (GLP) when handling the reagents.

SPECIMEN COLLECTION AND PREPARATION

- Erba Lyse-Di󰀨 lysing reagent is intended for use with blood specimens collected by vein puncture in EDTA anticoagulant. Specimens for hematological analysis may be stored for up to 8 hours at (+15 to +30) ºC or up to 24 hours after collection when refrigerated (+2 to +8) ºC.

REAGENT PREPARATION

- This reagent is ready for use and can be applied straight from the container; no special reagent preparation is necessary.

- Leave the reagent at room temperature for at least 12 hours.

REAGENT REPLACEMENT

- Person installing the reagent must be a trained laboratory professional.

- Remove the inlet cap from the reagent container to be replaced. Connect the reagent inlet to the new reagent container.

- Be sure that the colour on each tube, reagent container label and connector in the back of the instrument match.

- Avoid any dust or microbial contamination of the tubing and reagents. Do not pour and mix the remains of a reagent from a container into other one.

- Prime thoroughly the new reagent and measure backgrounds according to the instrument’s User Manual.

- When installing a new lot of reagent, recalibrate the instrument as specied in your User Manual.

REAGENT STORAGE, STABILITY AND DISPOSAL

- Store Erba Lyse-Di󰀨 lysing reagent between 15 and 30°C.

- The shelf life of the Erba Lyse-Di󰀪ysing agent is 48 months from date of manufacture, if stored at the prescribed temperature range.

- Do not use reagent beyond the expiration date printed on the container label.

- Discard opened container after 120 days.

- Do not use reagent once frozen.

- Dispose of waste product, unused product and contaminated packaging in compliance with local regulations.

IVD

Hematology reagents

Date of revision: 25. 7. 2017

See Instruction for Use

Catalogue Number Lot Number

Expiry date

In vitro Diagnostics

Storage Temperature

Content

CONT

Manufacturer

REF

CE Mark Device comply with the Directive 98/79/EC

USED SYMBOLS

IVD

50003764

50004171

HEMA/PI/09/17/B HEMA/PI/08/17/B

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Erba Lachema s.r.o., Karásek 2219/1d, 621 00 Brno, CZ e-mail: [email protected], www.erbalachema.com

Erba Cleaner

Cleaning solution for automated analyzers

Name Cat. No. Package volume

Erba Cleaner HEM00001

1 L

For in vitro diagnostic use only

INTENDED USE

Erba Cleaner is a stabilized and micro-ltered detergent solution for regular automated cleaning, rinsing and washing of hematology analyzers’ capillaries, tubing and chambers, removing blood component precipitates and lipoprotein deposits on Erba Lachema hematology analyzers. Erba Cleaner should be used with only Erba Lachema reagents. Erroneous results may be obtained if the reagent is applied with third party reagents. Please refer to the instrument’s User Manual for further information.

INGREDIENTS Detergents < 1.0 %

Bu󰀨ers < 1.0 %

Preservative < 0.5 % Stabilizers < 0.5 % in ion-free water

HANDLING PRECAUTIONS

- Erba Cleaner is environmental friendly, azide-free reagent; does not contain harmful ingredients.

- Avoid contact with eyes, skin and clothing.

- In case of eye or skin contact ush eyes with copious

amounts of water for several minutes or wash skin area with water.

- Keep the reagent container closed when not in use.

- Wear laboratory gloves when handling the reagent.

- All body uid samples should be considered potentially

infectious materials. Treat all blood and other potentially infectious materials with appropriate precautions. Use gloves, masks and gowns if blood exposure is anticipated.

- Use Good Laboratory Practices (GLP) when handling the reagents.

SPECIMEN COLLECTION AND PREPARATION Erba Cleaner reagent is intended for use with blood specimens collected by vein puncture in EDTA anticoagulant. Specimens for hematological analysis may be stored for up to 8 hours at (+15 to +30) ºC or up to 24 hours after collection when refrigerated (+2 to +8) ºC. Please refer to the instrument’s User Manual for further details.

REAGENT PREPARATION

- This reagent is ready for use and can be applied straight from the container; no special reagent preparation is necessary.

- Leave the reagent at room temperature for at least 12 hours.

REAGENT REPLACEMENT

- Person installing the reagent must be a trained laboratory professional.

- Remove the inlet cap from the reagent container to be replaced. Connect the reagent inlet to the new reagent container.

- Be sure that the colour on each tube, reagent container label and connector in the back of the instrument match.

- Avoid any dust or microbial contamination of the tubing and reagents.

- Prime thoroughly the new reagent and measure backgrounds according to the instrument’s User Manual.

- When installing a new lot of reagent, recalibrate the instru-

ment as specied in your User Manual.

REAGENT STORAGE, STABILITY AND DISPOSAL

- Store Erba Cleaner reagent between +15 and +30°C.

- The shelf life of the Erba Cleaner is 48 months from date of manufacture, if stored at the prescribed temperature range.

- Do not use reagent beyond the expiration date printed on the container label.

- Discard opened container after 120 days.

- Do not use reagent once frozen.

- Dispose of waste product, unused product and contaminated packaging in compliance with local regulations.

IVD

Hematology reagents

See Instruction for Use

Catalogue Number Lot Number

Expiry date

In vitro Diagnostics

Storage Temperature

Content

CONT

Manufacturer

REF

CE Mark Device comply with the Directive 98/79/EC

USED SYMBOLS

IVD

HEMA/PI/06/17/B Date of revision: 25. 7. 2017

50003767

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Erba Lachema s.r.o., Karásek 2219/1d, 621 00 Brno, CZ e-mail: [email protected], www.erbalachema.com

Erba Clenz

Enzymatic cleaner reagent for automated analyzers

Name Cat. No. Package volume

Erba Clenz HEM00017 1 L

For in vitro diagnostic use only

INTENDED USE

Erba Clenz enzymatic cleaner reagent is a stabilized and micro-ltered

proteolytic enzyme solution for regular automated cleaning, rinsing and washing of hematology analyzers capillaries, tubing and chambers, removing blood component precipitates and lipoprotein deposits on ELite hematology analyzers. Erba Clenz enzymatic cleaner reagent should be used only with Erba reagents. Erroneous results may be obtained if the reagent is applied with third party reagents. Please refer to the instrument User Manual for further information.

INGREDIENTS

Sodium chloride < 1.0% Proteolytic enzymes < 1.0% Preservative < 0.5% Stabilizers < 2.0% In ion-free water

HANDLING PRECAUTIONS

- Erba Clenz enzymatic cleaner is environmental friendly, azide-free reagent, does not contain harmful ingredients.

- Avoid contact with eye, skin and clothing.

- In case of eye or skin contact ush eyes with copious amounts of water

for several minutes or wash skin area with water.

- Keep the reagent container closed when not in use.

- Wear laboratory gloves when handling the reagent.

- All body uid samples should be considered potentially infectious materials.

Treat all blood and other potentially infectious materials with appropriate precautions. Use gloves, masks and gowns if blood exposure is anticipated.

- Use Good laboratory Practices (GPL) when handling the reagents.

SPECIMEN COLLECTION AND PREPARATION Erba Clenz reagent is intended for use with blood specimens collected by vein puncture in EDTA anticoagulant. Specimens for hematological analysis may be stored for up to 8 hours at 15-30°C or up to 24 hours after collection when refrigerated (2-8°C).

REAGENT PREPARATION

- This reagent is ready for use and can be applied straight from the container, no special reagent preparation is necessary.

- Leave the reagent at room temperature for at least 12 hours.

REAGENT REPLACEMENT

- Person installing the reagent must be a trained laboratory professional.

- Remove the inlet cap from the reagent container to be replaced. Connect the reagent inlet to the new reagent container.

- Be sure that the color on each tube, reagent container label and connector in the back of instrument match.

- Avoid any dust or microbial contamination of the tubing and reagents. Do not pour and mix the remains of a reagent from a container into other one.

- Prime thoroughly the new reagent and measure backgrounds according to the instrument User Manual.

- When installing a new lot of reagent, recalibrate the instrument as

specied in your User Manual.

IVD

See Instruction for Use

Catalogue Number Lot Number

Expiry date

In vitro Diagnostics

Storage Temperature

Content

CONT

Manufacturer

REF

CE Mark Device comply with the Directive 98/79/EC

USED SYMBOLS

IVD

Hematology reagents

REAGENT STORAGE, STABILITY AND DISPOSAL

Store Erba Clenz enzymatic cleaner reagent between 15 – 30°C. The shelf life of Erba Clenz is 24 months from the date of manufacture, if stored at the prescribed temperature range. Do not use reagent beyond the expiration date printed on the container label. Discard opened container after 120 days. Do not use reagent once frozen. Dispose of waste product, unused product and contaminated packaging in compliance with local regulations.

HEMA/PI/24/17/C Date of revision: 25.7. 2017

50004375

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Erba Lachema s.r.o., Karásek 2219/1d, 621 00 Brno, CZ e-mail: [email protected], www.erbalachema.com

Erba Hypoclean

Hypochlorite cleaning solution for automated analyzers

Name Cat. No. Package volume

Erba Hypoclean HEM00016 1 L

For in vitro diagnostic use only

INTENDED USE

Erba Hypoclean hypochlorite cleaning solution is a stabilized and micro-

-ltered hypochlorite solution for intensive oxidative cleaning, rinsing and washing of hematology analyzers capillaries, tubing and chambers, removing blood component precipitates and lipoprotein deposits on ELite hema-

tology analyzers. Erba Hypoclean hypochlorite cleaning solution should be used only with

Erba reagents. Erroneous results may be obtained if the reagent is applied with third party reagents. Please refer to the instrument User Manual for further information.

INGREDIENTS

Detergents < 1.0% Sodium hypochlorite < 1.0%

Sodium hydroxide < 0.5%

Stabilizers < 0.4%

In ion-free water

HANDLING PRECAUTIONS

Erba Hypoclean contains < 0.5% sodium hydroxide and < 1% sodium hypochlorite.

Warning

Hazard statement:

H315 Causes skin irritation. H319 Causes serious eye irritation. EUH031 Contact with acids liberates toxic gas.

Precautionary statement:

P280 Wear protective gloves/protective clothing/eye protection. P302+P352 IF ON SKIN: Wash with plenty of water. P305+P351+P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

- Avoid contact with eyes, skin and clothing.

- In case of eye contact ush eyes with plenty of water for several minutes and seek medical advice.

- In case of skin contact wash the skin area with water.

- If swallowed do NOT induce vomiting. Drink plenty of water and seek medical advice. Beware of aspiration if vomiting does occur.

- Keep the reagent container closed when not in use.

- Avoid any dust or microbial contamination of the reagents.

- Wear laboratory gloves when handling the reagent.

- Please refer to the MSDS associated with the reagent.

- Use Good Laboratory Practices (GLP) when handling the reagents.

SPECIMEN COLLECTION AND PREPARATION

Erba Hypoclean reagent is intended for use with blood specimens collected by vein puncture in EDTA anticoagulant. Specimens for hematological analysis may be stored for up to 8 hours at 15-30°C or up to 24 hours after collection when refrigerated (2-8°C).

IVD

Hematology reagents

REAGENT PREPARATION

- This reagent is ready to use and can be applied straight from the container, no special reagent preparation is necessary.

- Leave the reagent at room temperature for at least 12 hours.

REAGENT REPLACEMENT

- Person installing the reagent must be a trained laboratory professional.

- Remove the inlet cap from the reagent container to be replaced. Connect

the reagent inlet to the new reagent container.

- Be sure that the color on each tube, reagent container label and connector in the back of instrument match.

- Avoid any dust or microbial contamination of the tubing and reagents. Do not pour and mix the remains of a reagent from a container into other one.

- Prime thoroughly the new reagent and measure backgrounds according to the instrument User Manual.

- When installing a new lot of reagent, recalibrate the instrument as specied in your User Manual.

REAGENT STORAGE, STABILITY AND DISPOSAL

Store Erba Hypoclean hypochlorite cleaning reagent between 15 – 30°C. The shelf life of Erba Hypoclean is 24 months from the date of manufacture, if stored at the prescribed temperature range. Do not use reagent beyond the expiration date printed on the container label. Discard opened container after 120 days. Do not use reagent once frozen. Dispose of waste product, unused product and contaminated packaging in

compliance with local regulations.

HEMA/PI/25/17/C Date of revision: 25.7. 2017

See Instruction for Use

Catalogue Number Lot Number

Expiry date

In vitro Diagnostics

Storage Temperature

Content

CONT

Manufacturer

REF

CE Mark Device comply with the Directive 98/79/EC

USED SYMBOLS

IVD

50004376