Samsung LABGEOPA20 Users Manual

IVD

PA20

User Manual

Version 1.0

BCA-PA20

SAMSUNG ELECTRONICS CO., LTD.

129, Samsung-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, Korea

Distribution in USA : Nexus Dx, Inc., A Subsidiary of Samsung Electronics Co., Ltd., 6759 Mesa Ridge Road, San Diego, CA 92121 USA / Tel : 858-410-4600, Fax : 858-410-4700, www.nexus-dx.com

For proper use of the analyzer, please refer to the product manual.

The hardware/software mentioned in this user manual is protected by copyright law. Except for a copy of the User Manual for normal use, making a partial or whole copy of it without written permission by Samsung Electronics is strictly prohibited by copyright law. The content and specifications of this user manual are subject to change without prior notice.

Correct Disposal of This Product

(Waste Electrical & Electronic Equipment)

(Applicable in countries with separate collection systems)

This marking on the product, accessories or literature indicates that the product and its electronic accessories (e.g. charger, headset, USB cable) should not be disposed of with other household waste at the end of their working life. To prevent possible harm to the environment or human health from uncontrolled waste disposal, please separate these items from other types of waste and recycle them responsibly to promote the sustainable reuse of material resources. Household users should contact either the retailer where they purchased this product, or their local government office, for details of where and how they can take these items for environmentally safe recycling. Business users should contact their supplier and check the terms and conditions of the purchase contract. This product and its electronic accessories should not be mixed with other commercial wastes for disposal.

Table of Contents

1. Safety Warnings and Caution........................	7
User’s Manual and Labeled Symbols .................................	9
Cautions for system installation .......................................	11
Cautions for system move .................................................	12
Cautions before use ............................................................	12
Cautions during use............................................................	13
Precautions Before Testing ................................................	14
Preparing to Test Samples.........................................................................	14
Cautions for storage and maintenance after use..........	15
2. Introduction .................................................	17
Intended Use ........................................................................	18
Introduction .........................................................................	19
Operating Principle.............................................................	20
What’s in the box .................................................................	20
Box contents...................................................................................................	20
Sold separately..............................................................................................	21
Introduction of features.....................................................	22
Front (Right) ...................................................................................................	22
Front (Left) ......................................................................................................	23
Back ...................................................................................................................	24
3. Installation....................................................	25
Installation............................................................................	26
Replacing printer paper .....................................................	27

Samsung LABGEO PA20 Table of Contents

Disc.........................................................................................	29
Handling and Storage of the Disc ....................................	30
Adding the sample to the Disc..........................................	31
4. Analyzing......................................................	35
Analyzing ..............................................................................	36
Turning power on.........................................................................................	36
Preparing analysis ........................................................................................	40
Canceling analysis in progress ................................................................	43
Analysis completed ....................................................................................	45
Viewing analysis results .............................................................................	47
Viewing results.....................................................................	48
Viewing results of patient’s analysis ......................................................	50
Viewing QC results.......................................................................................	52
Searching results ..........................................................................................	54
Printing results ..............................................................................................	56
Transferring results ......................................................................................	61
Deleting results .............................................................................................	63
Quality control .....................................................................	65
Starting quality control ..............................................................................	65
Analyzer settings (General User Settings) ......................	69
Display settings ...................................................................	71
Calibration (touch screen calibration) ..................................................	72
LCD Brightness .............................................................................................	73
Screensaver settings....................................................................................	74
LCD Off settings ...........................................................................................	75
Volume settings ..................................................................	76
Analysis settings .................................................................	77
Unit settings ...................................................................................................	78
Change order.................................................................................................	80
Reference range settings ..........................................................................	82

Samsung LABGEO PA20 Table of Contents

QC material...........................................................................	84
Registering QC Material .............................................................................	84
Changing QC material ...............................................................................	89
Deleting QC material ..................................................................................	91
Print settings ........................................................................	93
Barcode settings .................................................................	95
Language settings ..............................................................	97
Self-test .................................................................................	99
Analyzer settings (Administrator Settings) ..................	103
Lock settings ......................................................................	105
Setting security levels for each function...........................................	105
Locking quality control ..........................................................................	107
Changing password .................................................................................	109
Network settings ...............................................................	112
Connecting to a network........................................................................	112
Setting network connections ..............................................................	114
Setting EMR/LIS..........................................................................................	116
Lock settings.......................................................................	117
Changing Date&time format ..........................................	119
System settings .................................................................	121
System Reset ..............................................................................................	123
USB Backup .................................................................................................	127
System updates .........................................................................................	129
Turning off power..............................................................	131
5. Using the LABGEO Data Manager.............	133
Introduction to the LABGEO Data Manager.................	134
Installation of the LABGEO Data Manager ...................	135

Samsung LABGEO PA20 Table of Contents

Running the LABGEO Data Manager .............................	139
Home screen.......................................................................	140
Registering a blood analyzer device ..................................................	141
Viewing analysis results ...................................................	147
Editing analysis results.....................................................	148
Selecting and editing multiple analysis results..............................	150
Printing analysis results ...................................................	151
Removing the LABGEO Data Manager..........................	153
6. Maintenance...............................................	155
Maintenance.......................................................................	156
Maintenance ...............................................................................................	156
Cleaning the exterior ...............................................................................	156
Cleaning the Disc Tray .............................................................................	157
Transportation and Storage...................................................................	157
7. Troubleshooting.........................................	159
Troubleshooting ................................................................	160
Check before requesting repair............................................................	160
Restoring factory settings ......................................................................	160
Error List ..............................................................................	161
8. Other Information......................................	165
Quaility control policy ......................................................	166
Westgard multi-rule technique ............................................................	166
System information...........................................................	167
Other information .............................................................	168
Product Service..................................................................	169
Index ....................................................................................	170

Safety Warnings and Caution

User’s Manual and Labeled Symbols .................................................	9
Cautions for system installation .......................................................	11
Cautions for system move .................................................................	12
Cautions before use ............................................................................	12
Cautions during use............................................................................	13
Precautions Before Testing ................................................................	14
Preparing to Test Samples.............................................................................................	14
Cautions for storage and maintenance after use..........................	15

Safety Warnings and Caution

Please follow the safety warnings and cautions in this manual for safe and appropriate use of the product.

Repairs and maintenance work not explained in this User Manual are to be performed by a designated Samsung service provider. Any attempt to repair the product by the user may result in injury. Do not use the product in an area with combustible gas or high levels of contamination for an extended period of time.

Malfunctions and damage caused by any other use than specified in the User Manual is excluded from the manufacturer’s warranty.

If the equipment is used in a manner not specified by the manufacturer, the protection provided by the equipment may be impaired.

Samsung LABGEO PA20 Safety Warnings and Caution

Ŷ User’s Manual and Labeled Symbols

Symbol Explanation

Biohazard. A sample as well as a used cartridge containing a sample are potentially hazardous. Handle with care.

Caution. In order to safely and properly use this product, safety precautions and cautions in this manual must be followed.

Consult instruction for use.

Temperature limitation/ Allowed Temperature Range Shows temperature limit for storage or transport

Fragile/Fragile contents; handle with care

Keep dry/Package should avoid wetting

This way up

Loading Unit/Avoid loading more than the marked number of units

In Vitro diagnostic device

Serial number

Manufacturer

USB port

Ethernet port

Samsung LABGEO PA20 Safety Warnings and Caution

Symbol Explanation

‘New’ waste The bar can be replaced by the date of manufacture

Catalog number

North American Safety Certification Mark

Alternating current

Power On

Power Off

Hot Surface

Risk of electronic shock

Stand-by switch

LASER CLASSIFICATION

This Clinical Chemistry and Immunology Analyzer is confirmed as the class 1 laser product in IEC60825-1:2007

-Wavelength: 808 nm

-Maximum output of laser radiation: Max. 1.5 W

Samsung LABGEO PA20 Safety Warnings and Caution

Ŷ Cautions for system installation

ŶKeep the analyzer at least 6 inches (15 cm) away from any wall to provide

adequate ventilation and prevent overheating.

ŶBe careful not to expose the analyzer to sources of vibration such as placing it near a centrifuge.

ŶDo not use the analyzer where liquids or chemicals are used or where gas may be produced. Insure that no liquids are spilled into the Unit if there is any spillage disconnect mains immediately and return to product for serving.

ŶThe analyzer must be used at an operating temperature of 10 - 32 °C (50 - 89 °F). The analyzer might be affected by:

t Condensing humidity and water

t Heat and extreme temperature variations t Electromagnetic radiation

t Movement of the analyzer during sample processing

ŶOnly use the cable provided with the analyzer.

ŶTo avoid risk of fire or electric shock, do not use a damaged power cable.

ŶAlways use the correct voltage supply. Incorrect voltage can cause damage to the analyzer or result in fire. Be sure that the electrical outlet is properly grounded.

ŶDo not attempt to disassemble, repair or modify the analyzer as damage could occur. Opening the unit will void the warranty. Contact Samsung Technical Support.

ŶDo not place any objects on the analyzer.

ŶDo not cover the rear ventilation panel. This may damage the internal parts, resulting in a fire or electric shock.

ŶDo not introduce foreign substances into the servicing hole.

ŶTurn on the power switch at the rear of the Analyzer. (Grounding Proper grounding is required when installing the system. Check the wall outlet ground (Earth) for proper grounding to the facilities electrical ground. If you are unsure of the outlet grounding, contact your facilities engineer to verify the proper outlet ground). Next, turn the power switch on the front of the Analyzer on and check that the program starts normally.

ŶDo not touch the power plug with wet hands. This may result in an electric shock.

Samsung LABGEO PA20 Safety Warnings and Caution

Ŷ Cautions for system move

ŶDropping the product while moving or carrying may cause damage to the

product.

ŶBe careful of impact when moving the product at all times.

ŶWhen moving the product by car, please use the original packaging material.

When moving the analyzer, first turn off the power and disconnect the power cable from the product.

Ŷ Cautions before use

ŶWhen the blood is not used immediately, be sure to store it appropriately to

prevent it from contamination.

ŶCheck for dust or other impurities on a regular basis.

ŶAlways install the product in a well-ventilated, clean, and dry area.

ŶKeep the product away from heat-emitting products (such as heaters). It may cause deformation of the product, fire, or adversely influence analysis results.

Samsung LABGEO PA20 Safety Warnings and Caution

Ŷ Cautions during use

ŶThis system is for professional use only. The user must be a physician, clinical

laboratory personnel, or healthcare professionals.

ŶAvoid external shock or vibration during analysis.

ŶDo not use expired discs.

ŶDo not open the tray while the disc is being analyzed. During the analysis, LED lamp or laser radiation may cause hazard due to improper operation.

ŶThe Analyzer contains UV/Visible LED Light source and laser. The users are not exposed to Optical radiation in normal conditions. Because it is blocked with analyzer cover cabinet. Do not open the tray during analysis. Do not look into the analyzer during analysis. Your vision will be damaged due to UV-lamp.

ŶPowder-free gloves must be worn when operating the product.

ŶDo not move the analyzer during operation.

ŶWhen inserting a disc into the tray, check the orientation of the disc. It must be inserted with the label side up. Consult test Instructions for Use.

ŶAlways use designated power cable. Do not unplug the device in the middle of an analysis.

ŶIf the product produces smoke or strange odors, discontinue use, unplug the power cord from the outlet, and contact your local distributor for service information.

ŶIf operation has been aborted due to abnormal circumstances such as a power outage during operation, discard the disc and start over with a new disc.

ŶDo not turn off the power during analysis. Press Cancel to abort a test if needed. Discard the disc and start over with a new disc.

ŶBe careful not to damage the barcode on the disc. If the barcode is damaged, the test will not perform accurately.

ŶDo not use the analyzer where liquids or chemicals are used or where gas may be produced.

ŶDo not allow liquid to spill into the analyzer. If there is any spillage, disconnect power immediately and contact your local distributor.

ŶIf you wish to stop the analysis in progress without turning the analyzer off , press the Cancel button and stop the analysis. After stopping an analysis in progress, throw away the cartridge and replace it with a new one.

ŶThe operating temperature of the analyzer is 10 - 32 °C (50 - 89 °F); the analyzer automatically maintains an internal temperature of 37°C. (The device shuts off automatically if it exceeds normal operating temperature.)

Samsung LABGEO PA20 Safety Warnings and Caution

Ŷ Precautions Before Testing

Preparing to Test Samples

1Prepare a disc, sample, and injecting tool (pipette) to be used for the test.

2Consult Test Instructions for Use.

3Use a pipette to inject the sample into the disc as described in the Test Instructions for Use.

Inlet

4Inject into the inlet shown in the figure above as described in the Test Instructions for Use.

Refer to the Test Instructions for Use for the correct sample volume to be injected into the disc.

Samsung LABGEO PA20 Safety Warnings and Caution

Ŷ Cautions for storage and maintenance after use

ŶDo not store the product in humid areas or areas influenced by

temperature, humidity or wind.

ŶStore the device on a flat surface and keep it away from vibration or impact.

ŶDo not store the product with chemicals or gas.

ŶOperating conditions and temperature: 10 - 32 °C (50 - 89 °F), Humidity: 0% - 80%

ŶStorage conditions and temperature: -10°C - +40°C , Humidity: 0% - 80%

ŶIf there is blood residue from a specimen or any contaminants in the disc tray and the interior or exterior of the analyzer, remove the contaminant using a soft cloth while wearing gloves.

Wet the cloth using 30% isopropyl alcohol when removing contaminants. Do not use highly corrosive agents such as benzene or acetone.

These agents may damage the analyzer.

ŶWhen moving or transporting the product, follow the conditions for using and storing the product specified in this manual. Follow all cautions when moving the product.

Ŷ A specimen may be contaminated with pathogens or viruses that cause infectious illnesses such as Hepatitis B. All specimens must be considered and handled as potential contaminants.

ŶUsed discs must be processed using Medical Waste Treatment Laws after use.

Samsung LABGEO PA20

Introduction

Intended Use ........................................................................................	18
Introduction .........................................................................................	19
Operating Principle.............................................................................	20
What’s in the box .................................................................................	20
Box contents ......................................................................................................................	20
Sold separately..................................................................................................................	21
Introduction of features.....................................................................	22
Front (Right) .......................................................................................................................	22
Front (Left) ..........................................................................................................................	23
Back.......................................................................................................................................	24

Introduction

Ŷ Intended Use

The Samsung LABGEOPA20 provides quantitative in-vitro measurements of clinical chemistry analytes and immunological reactions in lithium-heparinized whole blood, plasma, or serum in a clinical or point-of-care setting. It is designed to use a disposable reagent disc which contains reagents and buffers for a complete test. The Analyzer unit contains the Laser which is for controlling microfluidics. UV LED is light source is for detection chemical reaction.

For use in moderate complexity labs with whole blood, plasma or serum.

If the Samsung LABGEOPA20 is used in any way other than described in this manual, the analyzer may not operate as intended, may produce inaccurate or no results, and may pose a safety harzard.

Use only Samsung LABGEOPA20 reagent disc with the Samsung LABGEOPA20.

Samsung LABGEO PA20 Introduction

Ŷ Introduction

The Samsung LABGEOPA20 is a fully integrated photometric device that can perform both clinical chemistry analyses and immunoassays simultaneously. Innovative laser-actuated microvalves together with the centrifugal microfluidics makes the total process of plasma separation, metering, mixing, incubation, washing, and detection fully automatic.

A lithium-heparinized whole blood, plasma, or serum sample of 450uL is applied directly to a disposable reagent disc and the disc is inserted into the analyzer by an operator. Each reagent disc is self-contained clear plastic with diameter of 12 cm and thickness of 0.8 cm, which consists of different kinds of reagents and buffers.

The entire process is activated once the operator touches the “Run” button on the display. The ‘self-test’ function is initiated, whereby the main power, main motor, laser motor, temperature IC, photometer, laser, heater and barcode reader are checked. The ‘self-test’ function is conducted automatically before each test or control run. This built-in self testing function minimizes maintenance costs. After inserting a reagent disc into a tray, the analyzer automatically detects the disc type and identifies the clinical chemistry and immunoassay tests before performing the assays. The analysis is completed in about 12 to 25 minutes depending on the disc type.

The results are displayed on the LCD screen along with the reference ranges, can be printed out by an internal thermal printer, and can be transferred to a laboratory information system and electronic medical record systems (LIS/EMR) via an Ethernet and wireless LAN ports. Data storage is up to 5,000 patient results and 3,000 control results in the instrument.

The system provides user-friendly and easy interface for analysis that minimizes user manipulation. Handy compact design (246(W) x 375(D) x 289(H) mm3) allows maximized space utilization and the light weight (~ 9.2 kg) provides portability.

Compared to conventional blood analyses done in clinical laboratories, the analyzer system is suitable for point-of-care applications because it requires a smaller amount of blood takes less time, and does not require specially trained operators, or expensive instruments to run biochemical assays and immunoassays separately.

Samsung LABGEO PA20 Introduction

Ŷ Operating Principle

The analyzer is equipped with two optical detection modules. One is a photometer and the other is a fluorometer. The photometer can measure absorbance at 10 different wavelengths (340, 405, 450, 500, 550, 570, 600, 630, 660, and 700 nm) to accommodate various chemical and immunological reaction protocols. The measured absorbance is converted into the concentration of the analytes.

For endpoint reactions, the final absorbance is used for the calculation of the concentration of the analyte.For kinetic reactions, the absorbance change during a predetermined time is utilized for the calculation of the concentration instead of the final absorbance.

The fluorometer utilizes a time-resolved fluorescence method to support high-sensitivity immunoassay based on europium nanoparticle lables. A 365 nm LED is used as an excitation light source and a red-sensitive photomultiplier tube is used as a photodetector. The measured fluorescence intensity is converted into the concentration of the anlayte.

Ŷ What’s in the box

Box contents

	Power Cable
Analyzer Samsung	A 1.8m long cable used to supply power to
LABGEO PA20	the system. The effective voltage range is
BCA-PA20	between 100-240 VAC
	(50-60Hz).

Printer paper

USB Cable

Samsung LABGEO PA20 Introduction

User Manual

Software installation CD

Sold separately

Pipette

tips

Disc	Control Serum

Barcode scanner (optional)

t Please check the above contents of the box after purchase.

t If any of the contents are missing or damaged. Do not use the product and contact your retailer for a replacement.

Samsung LABGEO PA20 Introduction

Ŷ Introduction of features

Front (Right)

2 3 6

4
5	8
	8
	9

1.Main Unit

2.Printer

3.Printer feed button

4.7-inch Color TFT LCD Monitor

5.Tray

6.Power Button: Used to turn the analyzer on or off

7.USB Port: Used to update the software and to back up the analysis results in the USB memory

8.Servicing Hole: For qualified Samsung Technical Support personnel only

9.HOT SURFACE label

Samsung LABGEO PA20 Introduction

Front (Left)

1.Class 1 laser product label

2.Monitor tilting button

Samsung LABGEO PA20

Back

1	2
3

1.Power Switch: Used to turn the power to the analyzer on or off, turning off this switch completely cuts the power off.

2.Power Input: Connect the Power Cable here

3. USB Port : Used to update the software and to back up. The smaller port is provided for connecting to a computer

4.Ethernet Port : Used to connect to LAN or the Internet

5.Cooling Fan

6.Biological Hazard Warning

7.Displays basic information of the analyzer including product name, manufacturer, manufactured date and serial number

8.Motor Cover: To be removed for maintenance and only by authorized Samsung Technical Support personnel

9.Speaker

Installation

Installation............................................................................................	26
Replacing printer paper .....................................................................	27
Disc.........................................................................................................	29
Handling and Storage of the Disc ....................................................	30
Adding the sample to the Disc..........................................................	31

Installation

Ŷ Installation

1Carefully remove the analyzer from the packaging, and check for any damage that may have occurred during transport. If it is damaged, contact your courier or retailer immediately. Check and make sure that the contents of the box match the contents described in the User Manual. Contact your retailer if any component is missing.

2Place the analyzer on a level surface near an appropriate AC electrical outlet.

3Connect the power cable to the power input on the rear panel of the analyzer.

4Plug the power cable into the AC power outlet. The analyzer uses a switching-mode power supply (100 - 240 V).

5LAN and USB cables are used for PC software (LABGEO Data Manager) connections.

Samsung LABGEO PA20 Installation

Ŷ Replacing printer paper

1Open the paper lid (pull the lid upward by the handle).

2Remove the used roll.

3Unwind a new paper roll so that the leading edge comes out from the bottom, facing the user.

4Gently insert a new roll into the receptacle, and confirm that the paper comes out through the front of the printer while holding the leading edge.

Samsung LABGEO PA20 Installation

5Close the lid and confirm that the paper is positioned between the lid and the front of the printer.

Samsung LABGEO PA20 Installation

Ŷ Disc

The actual disc may differ from the images shown below.

1.Sample injection Hole

2.Reagent

3.Disc Barcode

4.Detection area (gray-colored zone)

Care must be taken to keep the detection area clear of fingerprints or other foreign substances.

Contamination of the detection area may affect the analysis results.

Samsung LABGEO PA20 Installation

Ŷ Handling and Storage of the Disc

Handle the discs carefully to avoid damaging them.

The disc is a high-technology integrated product but is vulnerable to impacts. Be careful not to bump the disc when transporting, handling or loading it. Do not use the disc if it has been dropped.

t Always use powder-free gloves when handling the product. t Store the disc LEVEL between 2 - 8 °C (36 - 46 °F).

t Use by the expiry date marked on the disc pouch or the package label. The analyzer detects and rejects a disc that has expired.

t Bring the disc in its unopened pouch to room temperature (18 - 25 °C or 64 - 77 °F) for at least 10 minutes before using it on the analyzer.

t The disc can be left at room temperate (18 - 25 °C or 64 - 77 °F) for a total of up to 12 hours if the pouch remains sealed. Do not use the disc if left at room temperature more than 12 hours.

t Do not expose the open disc to direct sunlight.

t Do not expose the disc to temperatures over 32 °C (89 °F).

t Do not use a disc if the pouch is cut or torn as the reagents inside may be damaged by moisture.

t Tear open the pouch at the notch located at the top edge. Once the pouch is opened, the disc must be used within approximately 10 minutes or discarded. It cannot be put back in the refrigerator for use at a later time.

t Be careful not to leave fingerprints or other contaminants in the detection areas of the disc.

t Keep the disc level at all times!

BIOHAZARD! Operator health and safety regulations require that Universal Precautions are to be observed whenever handling human blood samples or working with the Samsung LABGEOPA20. For additional information refer to OSHA 29 CFR Part 1910, Standard number 1910.1030 (Toxic and Hazardous Substances: Bloodborne Pathogens”). This can be found on the internet at http://www.osha.gov and going to “1910.1030.” Used discs contain human

blood. Care must be taken in handling used discs as the blood may have been infected by microbes that may cause infectious diseases such as hepatitis

B. The disc, once used, should be disposed of according to medical waste disposal rules.

For additional guidelines on handling and disposing of hazardous medical wastes, refer to “Clinical Laboratory Waste Management, Approved Guideline—Second Edition (GPS-A2) issued by the Clinical and Laboratory Standards Institute (previously known as NCCLS).

This can be found at http://clsi.org.

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