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Siemens ADVIA 2120 Operator'S Manual Download Page 342

Regulatory Information 

9-1 

 

Regulatory Information  

METHODS INTRODUCTION ...................................................................................... 4

 

O

VERVIEW

..................................................................................................................... 4

 

S

TATEMENT OF 

C

ONTENT

............................................................................................... 4

 

S

AMPLE 

C

OLLECTION AND 

P

REPARATION

...................................................................... 4

 

C

ALIBRATOR AND 

C

ONTROL 

P

RODUCTS

........................................................................ 5

 

A

NCILLARY 

R

EAGENTS

.................................................................................................. 8

 

O

PERATION

.................................................................................................................... 8

 

C

ALCULATION OF 

R

ESULTS

............................................................................................ 9

 

I

NTERPRETATION OF 

R

ESULTS

........................................................................................ 9

 

W

ASTE 

D

ISPOSAL 

R

EQUIREMENTS

............................................................................... 10

 

W

ASTE 

A

NALYSIS

........................................................................................................ 10

 

S

YSTEM 

M

ETHOD 

I

NFORMATION

.................................................................................. 13

 

S

YSTEM 

M

ETHOD 

I

NFORMATION

:

 

I

NTENDED 

U

SE

........................................................ 14

 

S

YSTEM 

M

ETHOD 

I

NFORMATION

:

 

P

RINCIPLES OF THE 

P

ROCEDURE

.............................. 14

 

S

YSTEM 

M

ETHOD 

I

NFORMATION

:

 

R

EAGENTS

............................................................... 14

 

S

YSTEM 

M

ETHOD 

I

NFORMATION

:

 

S

TORAGE AND 

S

TABILITY

....................................... 15

 

S

YSTEM 

M

ETHOD 

I

NFORMATION

:

 

S

AMPLE 

H

ANDLING

................................................. 15

 

S

YSTEM 

M

ETHOD 

I

NFORMATION

:

 

M

ATERIALS 

R

EQUIRED BUT NOT 

P

ROVIDED

............ 15

 

S

YSTEM 

M

ETHOD 

I

NFORMATION

:

 

P

ROCEDURE

............................................................ 15

 

S

YSTEM 

M

ETHOD 

I

NFORMATION

:

 

Q

UALITY 

C

ONTROL

................................................. 15

 

S

YSTEM 

M

ETHOD 

I

NFORMATION

:

 

G

AIN 

A

DJUSTMENT

................................................. 15

 

S

YSTEM 

M

ETHOD 

I

NFORMATION

:

 

C

ALIBRATION

.......................................................... 16

 

S

YSTEM 

M

ETHOD 

I

NFORMATION

:

 

R

ESULTS

................................................................. 16

 

S

YSTEM 

M

ETHOD 

I

NFORMATION

:

 

L

IMITATIONS OF THE 

P

ROCEDURE

........................... 16

 

S

YSTEM 

M

ETHOD 

I

NFORMATION

:

 

E

XPECTED 

V

ALUES

................................................. 17

 

S

YSTEM 

M

ETHOD 

I

NFORMATION

:

 

P

ERFORMANCE 

C

HARACTERISTICS

.......................... 17

 

CLSI DOCUMENT M29-A3 AND SIEMENS METHOD TOPICS CROSS 
REFERENCE................................................................................................................. 18

 

CBC METHOD.............................................................................................................. 21

 

I

NTENDED 

U

SE

............................................................................................................. 21

 

P

RINCIPLES OF THE 

P

ROCEDURE

................................................................................... 22

 

H

EMOGLOBIN 

C

ONCENTRATION

................................................................................... 22

 

R

EAGENTS

.................................................................................................................... 23

 

S

TORAGE AND 

S

TABILITY

............................................................................................. 26

 

G

AIN 

A

DJUSTMENT

...................................................................................................... 26

 

C

ALIBRATION

............................................................................................................... 26

 

S

AMPLE 

H

ANDLING

...................................................................................................... 27

 

M

ATERIALS 

R

EQUIRED BUT NOT 

P

ROVIDED

................................................................. 28

 

P

ROCEDURE

.................................................................................................................. 28

 

Q

UALITY 

C

ONTROL

...................................................................................................... 28

 

R

ESULTS

....................................................................................................................... 28

 

L

IMITATIONS OF THE 

P

ROCEDURE

................................................................................ 29

 

E

XPECTED 

V

ALUES

...................................................................................................... 29

 

P

ERFORMANCE 

C

HARACTERISTICS

:

 

I

MPRECISION

........................................................ 30

 

P

ERFORMANCE 

C

HARACTERISTICS

:

 

C

ORRELATION 

D

ATA

............................................ 30

 

P

ERFORMANCE 

C

HARACTERISTICS

:

 

C

ARRYOVER

......................................................... 31

 

P

ERFORMANCE 

C

HARACTERISTICS

:

 

A

NALYTICAL 

R

ANGE

............................................ 32

 

Summary of Contents for ADVIA 2120

Page 1: ...ADVIA 2120 2120i Hematology Systems Operator s Guide 067D0157 01 Rev 201 0 ...

Page 2: ...f Loctite Corporation Lysol is a trademark of National Laboratories Microsoft Windows NT and Windows are trademarks of Microsoft Corporation Monoject is a product of Sherwood Medical Monovette is a trademark of Sarstedt Incorporated Nokia is a trademark of Nokia Corporation Tapval is a trademark of Aquisel S L Teflon is a trademark of E I DuPont de Nemours Vacuette is a trademark of C A Greiner Sö...

Page 3: ...3 CLEANING THE SHEAR VALVE AND ASPIRATION PATHWAYS IN THE UFC 4 7 CLEANING THE SHEAR VALVE 4 7 INSPECTING AND CLEANING THE SYRINGE PLUNGERS 4 10 REPLACING THE SAMPLER NEEDLES 4 12 REPLACING THE SHEATH FILTERS 4 15 REPLACING THE 50 OR 1000 µL SYRINGE PLUNGERS 4 16 CLEANING THE AIR CIRCULATION FILTER 4 19 INSPECT THE PEROX CAP VENT HOLE FOR BUILDUP 4 20 CLEANING THE AUTOSAMPLER ASPIRATE ASSEMBLY 4 2...

Page 4: ...RDERING A SLIDE MANUALLY 10 12 STAINING MANUALLY SMEARED SLIDES 10 12 RESETTING THE AUTOSLIDE MODULE 10 13 STOPPING THE AUTOSLIDE MODULE FAST STOP 10 13 RUNNING THE DAILY SHUTDOWN MANUALLY 10 13 DISCONNECTING AN AUTOSLIDE 90 CONFIGURATION 10 14 AUTOSLIDE METHODS 10 18 PERIODIC MAINTENANCE 10 32 ERROR MESSAGES AND SUGGESTED ACTIONS 10 42 AUTOSLIDE SPECIFICATIONS 10 47 LEGAL INFORMATION A 1 LIMITED ...

Page 5: ...PAD 12 TOUCHSCREEN 13 MANUAL BARCODE READER 13 WASTE REMOVAL SYSTEM 14 HOW THE ADVIA 2120 2120I HEMATOLOGY SYSTEM WORKS 15 HOW THE ADVIA 2120 2120I SOFTWARE WORKS 16 STATUS LINES 16 MENUS 17 TABS 18 LEFT SIDE BUTTONS 18 MAIN DISPLAY AREA 18 BOTTOM BUTTONS 18 HELP BUTTON 18 SHORTCUT KEYS 18 WIZARDS 18 PRINTING THE SCREEN 19 RESULTS 20 SPECIFICATIONS 21 AUTOSAMPLER 21 DATA MANAGEMENT 21 PARAMETERS 2...

Page 6: ...iagnostic instrument with a throughput of 120 samples per hour CBC diff The analyzer uses whole blood samples to provide the following types of results Complete blood counts CBC CBC plus white cell differential counts CBC diff Reticulocyte absolute percent and indices counts retic CBC diff plus retic CBC diff retic CBC retic ...

Page 7: ...utions except SHEATH RINSE The waste system is a subcomponent of the analyzer 1 Autosampler 2 Manual open tube sampler 3 Manual closed tube sampler 4 Unifluidics technology 5 Perox optical assembly 6 RBC optical assembly 7 Hgb colorimeter assembly 8 Sample sheath and diaphragm pumps 9 Reagents sheath wash and rinse 10 Vacuum and pressure regulator knobs 11 Touchpad 12 Manual barcode reader 13 Wast...

Page 8: ...n VACUTAINER 0 6 10 x 64 Venoject 0 6 11 x 65 Sarstedt Monovette 2 7 1 0 11 x 74 Tapval 4 1 1 11 x 78 screw cap 4 1 2 11 x 83 Sarstedt Monovette 4 1 0 11 x 91 Sarstedt Monovette 5 1 0 12 x 75 6 Greiner Vacuette 2 4 1 0 12 x 80 screw cap 1 1 12 x 80 7 Exetainer 3 1 0 13 x 100 Becton Dickinson HEMOGARD 7 0 8 13 x 100 Greiner Vacuette 6 13 x 74 Monoject 5 0 6 13 x 74 Complexon 5 0 8 13 x 75 Becton Di...

Page 9: ...tification and the type of test requested is entered by the manual barcode reader or from the Manual Sample ID tab before starting sample aspiration Unified Fluids Circuit UFC The UFC assembly uses Unifluidics technology The UFC block is made up of eight acrylic plates Machined within these plates are the pathways for the fluids and air flow valves and four reaction chambers The perox reaction cha...

Page 10: ...tion for direct cytometry side view of the UFC 1 3 2 Reaction chambers The reaction chambers are machined pockets in the UFC assembly where the sample and reagents are mixed and the cytochemical reaction takes place There are five reaction chambers 1 Hgb Reaction Chamber Not Visible 2 Baso Reaction Chamber 3 RBC Reaction Chamber 4 Retic Reaction Chamber 5 Perox Reaction Chamber 1 2 3 4 5 The perox...

Page 11: ...ell by cell measurement of light scatter and absorption The hemoglobin colorimeter assembly 2 takes voltage readings that correspond to the amount of transmitted light that passes through the reaction chamber The system uses the readings to derive the hemoglobin concentration The laser optical assembly 3 uses a laser diode light source This optical assembly is shared by the RBC Plt retic and baso ...

Page 12: ...nverts the optical scatter and absorption signals from each white blood cell into two signal currents for each of the two channels scatter and absorption Preamplifiers convert these optical signals into signal voltages Laser Optical Assembly A D A N G E R W33 W32 B C A Illuminator Assembly B Flowcell Location C Detection Assembly The laser optical assembly consists of the illuminator flowcell and ...

Page 13: ...igh Angle Scatter Detector Hemoglobin Colorimeter Assembly B A C A Lamp Assembly B Hgb Reaction Chamber C UFC Assembly The hemoglobin colorimeter assembly straddles the UFC block C at the top The colorimeter contains a light source A set at 3 5 Vdc and a 565 nm or 546 nm interference filter according to the HGB method selected The hemoglobin reaction chamber B is built into the UFC assembly Hemogl...

Page 14: ... to a digital form by the Hgb Interface Board and sent to the analyzer CPU to calculate the optical density and derive the Hgb concentration Sample Sheath and Diaphragm Pumps 2 1 3 4 The perox sample 1 and sheath 2 pumps are located on the left side of the analyzer The RBC baso retic sample 3 and sheath 4 pumps are located on the right side of the analyzer The diaphragm pumps for sheath rinse and ...

Page 15: ...pumps 5 push the sheath 6 through the sheath filters 7 directly into the flowcells The sheath pumps 8 pull the PEROX SHEATH or SHEATH RINSE and the reacted sample stream 9 through the flowcells for analysis The analyzed sample and sheath are sent to waste 10 and the lines flowcells and reaction chambers are washed and rinsed V15 V8 V5 V6 V7 V16 V17 V18 DP1 V26 V24 V25 3 8 1 7 4 5 6 10 10 9 2 2 2 2...

Page 16: ...cytochemical reagents are located on the analyzer and except for the SHEATH RINSE and DEFOAMER they are monitored on a cycle by cycle basis The SHEATH RINSE is in a CUBITAINER placed on the floor Vacuum and Pressure Regulator Knobs 20 In Hg Vacuum Regulator Knob 40 PSI Pressure Regulator Knob 5 PSI Pressure Regulator Knob 20 PSI Pressure Regulator Knob Touchpad Start Stop Sampler Eject Rack Rack i...

Page 17: ...or you to perform your daily tasks directly at the monitor without using the keyboard On the touchscreen monitor you can do the following Use your finger with or without gloves to select all window controls including function buttons and operations in the online Help Move a window by holding your finger on the title bar of the window drag the window to the new location NOTE The touchscreen may not...

Page 18: ...and alone container which has to be emptied manually or part of the automatic waste removal system When the fluid level in either of the containers reaches the maximum level line approximately 8 liters an error message appears on the Status line on the personal computer monitor The analyzer will not aspirate any more samples until the waste container is emptied ...

Page 19: ...shear valve rotates it shears or divides the sample into aliquots for the different types of tests 24 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 BASO RETIC RBC HGB PEROX 5 4 V74 V2 V72 V73 V47 V1 Rinse Trapped in Lines Lines that are Dry Lines with Sample Line with Vacuum Conductivity Detector Rinse Source Probe Vacuum Source The reagents and sample segments are delivered to their...

Page 20: ...iewed and edited How the ADVIA 2120 2120i Software Works The ADVIA 2120 2120i system software is a special purpose program that runs on the Windows NT operating system You can navigate through the software and operate the system using the mouse 1 Status lines 2 Menus 3 Tabs 4 Left side buttons 5 Main display area 6 Bottom buttons 7 Help button 8 Shortcut keys Status lines There are two status line...

Page 21: ...click the item for which you want help Second Status Line Left Side Current system state for example Ready to Run Right Side System messages and icons that indicate the message severity Information accompanies a message that provides information only No operator action is necessary Warning alerts you to a condition that requires some action Failure alerts you to a serious problem that requires you...

Page 22: ...opening the one you want Some windows however do not close automatically and require that you click an Exit button before you change to a new one Bottom buttons These buttons activate commands or manipulate the contents of the window Help button When you need detailed Help that provides step by step instructions for operating the ADVIA 120 click the Info button To get brief What s This Help click ...

Page 23: ... IMPORTANT You can print any screen by pressing the Print Screen key However pressing the Print Screen key when there is no printer attached to the system can cause the system to malfunction Make certain that there is a printer attached before you attempt to print the screen ...

Page 24: ...ampler the selectivity will always revert back to the default setting The system alerts you to questionable results and potential system conditions in three ways Sample system flags are codes displayed in the Review Edit tab and the Run Screen These codes are associated with a specific test parameter marked by an asterisk Isolated instances of flags are usually sample related However multiple occu...

Page 25: ...s up to 14 digits Automatic label code discrimination Codabar Interleave 2 of 5 with and without check digit Code 39 Code 128 EAN and JAN 8 and 13 Data Management Database storage capacity of 10 000 records including graphics Review and edit capability User defined windows User defined reports User defined ranges based on age and sex for Normal Rerun Panic and Delta Check criteria Bi directional a...

Page 26: ...O HYPER RBC Fragments RBC Ghosts NRBC Platelet Clumps Large Platelets Blasts Limitations Smear review by a competent morphologist is necessary to ensure detection of significant blood cell abnormalities Each laboratory is responsible for developing it s own protocols for determining which samples require smear review and or manual differential blood cell counts based on automated cell count result...

Page 27: ...o 1 for all parameters Personal Computer Specifications minimum Processor Intel Celeron 2 2 GHz with 512K Cache 400MHz Front Side Bus Processor Hyper Threading Disabled Hard Drive 40GB 7 200 rpm IDE Hard Drive Parallel ATA DiamondMax Plus 8 40GB ATA 133 HDD CD RW 48x CD RW Read Write Drive NEC CD R RW Drive Model NR 9300A Removable storage 3 5 1 44Mb floppy Drive Samsung SFD 321J ADNR Network Card...

Page 28: ...be configurable to meet limitations below BIOS Limitations Power management Suspend Mode S3 AC Power Recovery Off Low Power Mode Disabled Remote Wake Up Off Chassis Small Desktop External Diskette Bays 1 x 3 5 Floppy Bay 1 x 5 25 Floppy Bay Internal Drive Bays 1 108 x 390 x 431mm Power supply 210W Model HP U2106F3 Rev H01 Physical Specifications Electrical Power Requirements Voltage selectable for...

Page 29: ...nts Weight Height Width Depth 191 9 kg 85 cm 141 cm 68 cm 422 5 lbs 33 4 in 55 5 in 26 8 in Weight Height Width Depth 161 9 kg 85 cm 81 cm 68 cm 357 5 lbs 33 4 in 31 9 in 26 8 in Personal Computer CPU Monitor Weight 10 6 cm 4 2 in 7 0 kg 15 43 lbs Height 38 9 cm 15 3 in Extended in Landscape 54 6 cm 21 50 in Compressed in Portrait 38 0 cm 14 96 in Width 38 9 cm 15 3 in 37 6 cm 14 8 in Depth 9 9 kg...

Page 30: ...1 26 Welcome to the ADVIA 2120 2120i Hematology System ...

Page 31: ...tem On Off 2 1 Turning the System On Off OVERVIEW 2 TURNING THE SYSTEM ON 2 TURNING THE SYSTEM OFF 4 TURNING THE SYSTEM OFF IN AN EMERGENCY 4 TURNING THE SYSTEM OFF ROUTINELY 4 EXITING THE ADVIA 2120 2120I SOFTWARE 4 ...

Page 32: ...elect Ctrl Alt and Delete at the same time to log on to Windows c Enter the operator name and password in the Logon Information box select OK d Once you have logged on to Windows using an operator name and password the computer automatically starts the ADVIA 2120 2120i software NOTE If you log on using a supervisor name and password the system opens the ADVIA 2120 2120i Shell 3 Turn on the analyze...

Page 33: ...t 60 seconds and then restart it If the error recurs call your Service Representative c The system automatically opens the Startup tab Review the status of the Startup process IMPORTANT In cases when the analyzer is turned off and restarted too quickly the compressor may not start up causing the system initialization to fail This is due to residual vacuum in the waste container The operator must m...

Page 34: ... in an emergency it is unable to drain some lines as it would normally As a result when you restart the system you should perform a System Wash using the Hydraulic Functions tab on the Utilities menu before running samples Turning the system off Routinely 1 At the Routine Operations menu select Log On Off 2 Select Shut Down ADVIA Wait 1 2 minutes while the software shuts down 3 Set the computer po...

Page 35: ...E 4 CHECKING THE REAGENTS 4 OBTAINING THE BACKGROUND COUNTS 4 PROCESSING THE SAMPLES 5 CREATING THE WORKORDERS 5 LISTING THE PENDING WORKORDERS 6 RUNNING THE SAMPLES 6 VIEWING THE SAMPLE RUN 8 VALIDATING THE RESULTS 9 ENDING EACH SHIFT 10 WASHING THE SYSTEM 10 PERFORMING THE END OF DAY PROCEDURE 10 LOGGING OFF 11 ...

Page 36: ...dling and disposal laws and regulations in your area All analyzer waste is stored in an 11 liter waste container When the fluid level in the container reaches the Maximum Level line approximately 8 liters an error message appears on the monitor and an audible alarm is sounded The system will not aspirate any more samples until the waste container is emptied Manual Waste Removal CAUTION Make sure a...

Page 37: ... and damage the system IMPORTANT In order to empty the automatic waste removal system the analyzer must be on and must not be in Standby mode 1 Make sure that the analyzer is not sampling 2 If a message requesting a rinse or a wash appears select Cancel 3 Disconnect the level sensor switch connector 1 by selecting its button CAUTION To prevent sample aspiration while the automatic waste removal sy...

Page 38: ...y 1 Visually check the fluid level in the small overflow bottle 1 located to the right of the RBC sample and sheath pumps If it has any liquid in it empty the bottle 2 Snap the bottle 1 out of the clip then remove the bottle cap 2 You can allow the lines 3 with the cap to hang loosely 1 3 2 3 Empty the contents of the bottle in accordance with proper laboratory practices and environmental regulati...

Page 39: ... from field to field 4 Select tests 5 Select OK to confirm the entries 6 The Access dialog box appears for the next workorder Creating Workorders by Patient 1 At the Access menu select Pat 2 In the Pat box enter the patient number then select Enter or select OK If there is more than one workorder for this patient they are listed 3 Select Create to make a new workorder for this patient 4 Enter samp...

Page 40: ...isplay to view the list or select Print to print it Running the Samples Control Recommendations Run controls in accordance with your laboratory protocol Run multilevel controls at the beginning of each shift Siemens recommends the use of ADVIA TESTpoint Hematology Controls Low Normal and High and ADVIA TESTpoint Reticulocyte Control Low and High Run controls alone or at the start of the patient wo...

Page 41: ...Patient samples sample ID label 3 Scan the tube label or enter the sample information in the Manual Sample ID tab IMPORTANT Make sure the correct sample ID appears on the status line before aspirating a sample using either the manual open tube sampler or the manual closed tube sampler Waiting displays on the status line while the system searches for a matching workorder Make sure the correct sampl...

Page 42: ...he sample a Position tube so that the sampler probe is immersed into the well mixed sample b Immerse the sampler probe only deep enough approximately 0 25 in to ensure aspiration c Press the aspirate plate The sampling light flashes during aspiration d When the sampling light stops flashing remove the tube 5 Evaluate control results or validate patient results when available Viewing the Sample Run...

Page 43: ...n using the same sample ID The letter R displays in D box Exchange swaps information in C RES and PREV RUN boxes The letter X displays in D box Accept indicates result approved by operator The letter A displays in D box Delete erases the result The letter D displays in D box Dil Sample repeats test with specified dilution using a different sample ID When result is available select Dil Cons Diluted...

Page 44: ...operation now appear 4 Select the SID RESET check box to perform a SID RESET 5 If desired select the Q C Close Out check box to transfer the daily QC file into the Cumulative QC file Use the list box to select close out for all controls or a specific control 6 If desired select the MOV AVG Close Out check box to obtain a cumulative data point from moving average control statistics with a date earl...

Page 45: ...grams Format one or more disks with the label PRG Dictionaries Format one disk with the label DICT Cumulative Quality Control Format one disk no label is necessary Database Four formatted disks are required for 2000 All Complete sample records The database disks do not need to be labeled The system will automatically label the disk s during the backup procedure When several disks are required the ...

Page 46: ...3 12 Daily Routine ...

Page 47: ...HE SHEAR VALVE FACES 9 CLEANING THE SHEAR VALVE STEP 3 PUTTING THE SHEAR VALVE BACK TOGETHER 9 CLEANING THE SHEAR VALVE STEP 4 CHECKING ANALYZER PERFORMANCE 10 INSPECTING AND CLEANING THE SYRINGE PLUNGERS PN 067 506 01 AND PN 067 506 02 10 REPLACING THE SAMPLER NEEDLES 13 REPLACING THE SHEATH FILTERS 15 REPLACING THE 50 OR 1000 µL SYRINGE PLUNGERS PN 067 506 01 AND 067 506 02 16 CLEANING THE AIR C...

Page 48: ...rform an RBC baso retic flowcell wash Clean shear valve and aspiration pathways in the UFC Inspect the centering collars Clean if necessary Turn off the system Clean the shear valve After 16 000 samples or every two months Inspect the syringes and plungers PN 067 B506 01 and PN 067 B506 02 Clean if necessary Replace the 50 μL syringe plungers PN 067 B506 01 Inspect the Perox cap vent hole for buil...

Page 49: ...ft 3 100 Samples 1 system wash at the end of the shift Example 2 Laboratory workload of 300 samples day Shift 1 175 Samples 3 system washes at the end of the shift Shift 2 75 Samples 1 system wash at the end of the shift Shift 3 50 Samples 1 system wash at the end of the shift Example 3 Laboratory workload of 350 samples day Shift 1 350 Samples 3 system washes at the end of the shift IMPORTANT Eac...

Page 50: ... Cotton swab Household bleach Paper towels Stylet or thin wire Syringe Tubing 0 020 inch ID Time 10 minutes per centering collar Analyzer mode Off WARNING The analyzer must be off otherwise personal injury from the needle may occur To clean the centering collar WARNING To avoid personal injury and exposure to a potential biohazard you must cover the needle with the red needle cover immediately aft...

Page 51: ... carefully replace the collar over the needle On the autosampler centering collar be sure to turn the spring loaded knob back to its original position 9 On the autosampler reposition the autosampler aspirator assembly Make sure that it drops firmly in place over the guide pins then reconnect the sample line to the base of the centering collar CAUTION After repositioning the aspirator assembly fing...

Page 52: ...ring loaded knob 3 turn it a turn then remove the centering collar 4 by pulling it up and out NOTE If the centering collar is locked into place squirt a little warm DI water over the collar to loosen it 5 Place the red needle cover over the needle 6 Remove the three tubes from the collar To remove the centering collar from the manual closed tube sampler 1 Tilt the front cover down 2 Pull the cente...

Page 53: ... V72 to open Make sure that V73 is closed 9 Repeat steps 4 and 5 10 Select V74 and V72 to close and select V73 to open 11 Repeat steps 4 and 5 12 Close valves V1 V47 and V73 Exit the Exerciser by selecting the Analyzer Status tab Cleaning the Shear Valve Materials required Beaker Household bleach Paper towels Squirt bottle Ultrasonic bath if available Time Cleaning 15 minutes Checkout 15 minutes A...

Page 54: ...ation on user protection and it can be used as reference material for instructions on laboratory safety To clean the shear valve 1 Take the shear valve apart 2 Clean the shear valve 3 Reassemble the shear valve 4 Check the analyzer Cleaning the Shear Valve Step 1 Taking the Shear Valve Faces Apart IMPORTANT Place paper towels directly under the shear valve to prevent fluid from dripping down into ...

Page 55: ...use the shear face removal tool PN 067 1083 01 found in the spare parts kit Gently wedge the sharp edge of the tool between the two faces then remove the front shear face Cleaning the Shear Valve Step 2 Cleaning the Shear Valve Faces 1 Place the front shear face in a beaker with household bleach If the laboratory is equipped with an ultrasonic bath follow the instructions provided by the manufactu...

Page 56: ...alve Step 4 Checking Analyzer Performance Check analyzer performance by Checking saline backgrounds Running a whole blood primer Running controls If controls do not recover calibrate affected channel Inspecting and Cleaning the Syringe Plungers PN 067 506 01 and PN 067 506 02 Inspect the tip of the plunger during a saline prime The normal wear of the plunger tip sheath 1 1000 μL syringe and sample...

Page 57: ...tory Workers from Infectious Disease Transmitted by Blood Body Fluids and Tissue 2d edition Approved Guideline 1997 Document M29 A National Committee for Clinical Laboratory Standards NCCLS This document contains complete information on user protection and it can be used as reference material for instructions on laboratory safety To clean the syringes and plungers 1 Remove the syringe a Turn the t...

Page 58: ...all debris is removed from the grooves 3 Thoroughly rinse the syringe barrel with water 4 Slide the cleaned plunger into the syringe Use a little saline solution if necessary Reseat the small plastic bushing into the syringe barrel then replace the syringe a Insert the bushing end of the syringe into the slot at the bottom of the carriage b Make sure that the input port on the RBC Baso Retic chann...

Page 59: ...human or animal body fluids should be handled before and after cleaning as if capable of transmitting infectious diseases Wear facial protection gloves and protective clothing The operator should follow the recommendations to prevent the transmission of infectious agents in health care settings as recommended for potentially infectious specimens in Protection of Laboratory Workers from Infectious ...

Page 60: ...reful not to cross thread the needle 1 CAUTION Do not use any other tools to secure the needle Overtightening can affect needle performance c Remove the red cover from the needle and save it for use during the next needle installation 7 Reconnect all the tubes except the sample line on the autosampler to the centering collar Analyser Autoslide centering centering collar collar V43 V44 V45 MCTS V46...

Page 61: ...wo sheath filters located on either side of the analyzer The perox sheath filter is in a green housing on the left side and the RBC baso sheath filter is in a clear housing on the right side of the instrument Time 10 minutes Materials required Perox sheath filter PN 518 3148 05 RBC baso sheath filter PN 518 3148 06 paper towels Analyzer mode Ready to Run Location of the perox 1 and the RBC baso 2 ...

Page 62: ...d 6 Still holding the filter by the center of the body connect the reagent line to the barbed fitting of the input port 7 Insert the sheath filter into the mounting clip with the input end of the filter facing up 8 Prime the reagent lines five times CAUTION Do not use a syringe to prime the filter It may cause damage to the filter 9 Look at the level of the liquid in the sheath filter If the filte...

Page 63: ...NCCLS This document contains complete information on user protection and it can be used as reference material for instructions on laboratory safety To replace the syringe plunger 1 Turn the thumb wheel 1 counterclockwise until the plunger is lowered about 0 5 inch 1 27 cm 2 Disconnect the tubing from the top fittings then disconnect the input 2 and output 3 fittings from the syringe head 3 Remove ...

Page 64: ...ip c On the 50 µL syringe replace the small plastic bushing into the syringe d Replace the metal bushing onto the plunger stem with the narrow collar of the bushing 5 toward the plunger 6 e Push the metal bushing up against the syringe then tighten the set screws 4 f Remove the pin gauge from the input port a 6 5 7 Reinstall the sample syringe a With the metal bushing end first insert the syringe ...

Page 65: ...urface or by vacuuming 3 Flush the filter with a strong stream of water first on one surface then on the other surface Location of the air filter 1 4 If the filter remains dirty swish it around in a container filled with warm water and mild detergent 5 Rinse the filter with clean water then allow it to air dry Replace the filter by sliding it back into its frame Inspect the Perox Cap Vent Hole for...

Page 66: ...ious agents in health care settings as recommended for potentially infectious specimens in Protection of Laboratory Workers from Infectious Disease Transmitted by Blood Body Fluids and Tissue 2nd edition Approved Guideline 1997 Document M29 A National Committee for Clinical Laboratory Standards NCCLS This document contains complete information on user protection and it can be used as reference mat...

Page 67: ...the centering collar and the assembly 7 Allow to stand for 5 minutes then wipe the assembly dry with paper towels and cotton swabs Repeat if necessary 8 Reposition the assembly Make sure that it drops firmly into place then reconnect the sample line CAUTION After repositioning the aspirator assembly finger tighten the thumb screws being careful that they are not cross threaded Overtightening of th...

Page 68: ...BERS 21 BACKFLUSHING THE RBC BASO RETIC FLOWCELL AND SHUTTLE AND REACTION CHAMBERS 23 REPAIR AND REPLACEMENT 25 REPLACING THE CLOT FILTERS 25 REPLACING THE DIAPHRAGM PUMPS 26 REPLACING THE DRAIN FILTERS 27 REPLACING A PEROX CHECK VALVE 29 REPLACING THE FRONT SHEAR FACE OR THE SHEAR VALVE ROTOR 29 REPLACING THE FUSES 31 REPLACING THE HEMOGLOBIN COLORIMETER LAMP 33 REPLACING THE HYDRAULIC VALVES 34 ...

Page 69: ...djust the Hgb baseline value 1 At the Procedures menu select the Adjust Lamp Temp tab 2 Select Hgb Baseline 3 Pop out the small white plug on the colorimeter to access the potentiometer adjustment screw on the Hgb Power Supply Preamp PCB Potentiometer 1 on the Hgb Power Supply Preamp Board 4 Select Start Cycle As the analyzer is checking the baseline value use a small screwdriver to turn the adjus...

Page 70: ...and using a sharp scalpel or a single edged razor blade cleanly cut the probe to the appropriate length Be very careful to make the cut straight without burrs Do not cut the probe on an angle 3 Replace the probe and check the length Adjusting the Pneumatic Regulators 1 To gain access to the knobs snap open the white panel on the right side of the analyzer Using a Phillips head screwdriver remove t...

Page 71: ...ox Lamp Alignment 3 Select Start Cycle 4 Monitor the Current A D Reading field 5 Loosen the two securing screws 1 Do not loosen the four corner screws 4 6 Perform the following procedure even if the initial maximum lamp value is greater than 1 96 Use the side alignment screw moves the lamp in a horizontal direction 2 and the top alignment screw moves the lamp in a vertical direction 3 to peak the ...

Page 72: ...t Light Intensity Check the gains for the Perox channel Reprogramming the Manual Barcode Reader 1 Locate the Codabar Settings in the Opticon User s Manual 2 Scan the Start Z7 barcode with the wand The barcode reader should be emitting a constant beeping sound which is an indication that it is in the programming mode 3 Scan the Do not transmit Start Stop F0 barcode You should hear a single high pit...

Page 73: ...e 2nd edition Approved Guideline 1997 Document M29 A National Committee for Clinical Laboratory Standards NCCLS This document contains complete information on user protection and it can be used as reference material for instructions on laboratory safety To backflush the drain filters 1 Turn the analyzer off 2 Prepare a 10 household bleach solution 3 Unscrew the fittings from each end of the drain ...

Page 74: ...gh the filters properly Make sure that the lines do not interfere with the autosampler aspirator motion Cleaning the Perox Chamber BIOHAZARD All products or objects that come in contact with human or animal body fluids should be handled before and after cleaning as if capable of transmitting infectious diseases Wear facial protection gloves and protective clothing The operator should follow the re...

Page 75: ...e back wall using a circular up and outward motion 3 Using a 2 mm disposable pipette fill the chamber 1 3 full with EZ KLEEN 4 Using the pipette agitate the liquid in the chamber then let it soak for one minute 5 Agitate the liquid again Then using the pipette remove all the liquid from the chamber 6 Check if there are any black particles in the liquid If yes repeat steps 3 through 6 until the EZ ...

Page 76: ...leach and water 5 At the Exerciser select V45 to open the valve 6 Aspirate 10 mL of the bleach followed by 10 mL of deionized water 7 At the Exerciser select V45 to close the valve 8 Replace the tubing on the centering collar nipple and exit the Exerciser window Cleaning the Vent Lines Vacuum Shuttle Chambers and Reaction Chambers Materials required Beaker Deionized water EZ KLEEN for cleaning per...

Page 77: ...t Select the appropriate valves The appropriate valves are Baso chamber open V13 Perox vacuum shuttle chamber open V18 and V17 Retic chamber open V65 RBC chamber open V10 RBC baso retic vacuum shuttle chamber open V22 and V21 Hemoglobin chamber open V36 4 Allow alternate segments of household bleach solution and air to run through the line and the chamber until they are clean 5 Immerse the free en...

Page 78: ... the Flowcells on the Analyzer This method of cleaning the flowcells bypasses the shear valve and the UFC pathways Materials required Beaker Household bleach Time 10 minutes Analyzer mode Ready to Run BIOHAZARD All products or objects that come in contact with human or animal body fluids should be handled before and after cleaning as if capable of transmitting infectious diseases Wear facial prote...

Page 79: ...t V23 and V27 If you are cleaning the perox flowcell select V25 and V24 3 Allow alternate segments of air and bleach solution to be pulled through the sample line 4 Put water into a beaker and flush the line clean by allowing water to be pulled through the line 5 Replace the sample line and close all valves 6 To clean the sheath or shuttle lines follow the same procedure When cleaning the sheath l...

Page 80: ...event the transmission of infectious agents in health care settings as recommended for potentially infectious specimens in Protection of Laboratory Workers from Infectious Disease Transmitted by Blood Body Fluids and Tissue 2nd edition Approved Guideline 1997 Document M29 A National Committee for Clinical Laboratory Standards NCCLS This document contains complete information on user protection and...

Page 81: ...is in the Standby mode 2 Open the optics cover The perox flowcell is on the left Perox flowcell 1 RBC flowcell 2 3 Disconnect the shuttle line 1 the sample stream input line 2 and the sheath stream input line 3 from the CFM Allow these lines to hang freely 1 SHEATH NIPPLE 2 SAMPLE NIPPLE 3 SHUTTLE NIPPLE 4 Locate hydraulic valve 24 Unscrew the threaded fitting from the top right side of the valve ...

Page 82: ...e red threaded fitting located at the top of the flowcell then gently lift the flowcell out of the optics assembly CAUTION To avoid getting fingerprints on the glass windows of the flowcell always hold the flowcell by the metal slides Cleaning the Flowcells off the Analyzer Step 1 Removing the RBC BASO Retic Flowcell Before you begin the cleaning of the RBC baso retic flowcell read all laser safet...

Page 83: ...tion from a shiny surface All field service procedures must be followed precisely Only Siemens trained field service personnel should perform procedures related to laser assemblies For more safety information and laser specifications refer to Safety Information Protecting yourself from lasers 1 Make sure that the analyzer is in the Standby mode 2 Open the optics cover The RBC flowcell is on the le...

Page 84: ...hydraulic valve 23 Unscrew the threaded fitting from the top left hand side of the valve 5 Loosen the captive flowcell release screw then remove the flowcell Flowcell 1 flowcell release screw 2 6 Hold the flowcell by the red threaded fitting when lifting the flowcell out of the optics assembly ...

Page 85: ...n vise 1 and a 1 64 inch 0 4 mm diameter drill bit 2 are supplied in the Flowcell Cleaning Kit Open the pin vise insert the drill bit approximately 1 4 inch 6 4 mm into the vise jaws then tighten the pin vise 2 Insert the drill bit into the sheath nipple 3 Using a twisting motion carefully push the drill bit through the sheath nipple If a clog is encountered proceed slowly while continuing to twis...

Page 86: ...lowcell and out the open nipple 5 Switch one end of the knotted tubing to the cleaned nipple 6 Disconnect the syringe and the adapter and draw 10 mL of the appropriate fluid into the syringe Flush the flowcell with the fluid now exiting through the second nipple 7 Repeat the flushing for the third nipple 8 Repeat steps 2 through 7 using water to rinse out the flowcell and the CFM 9 Disconnect the ...

Page 87: ...yzer Step 6 Replacing the Flowcell 1 Hold the flowcell by its red threaded fitting and place it gently into the optics assembly 2 Perox optical assembly Tighten the release knob to lock the flowcell into position RBC baso retic optical assembly Place the flowcell onto the guide pins Make sure that the flowcell is on both guide pins The flowcell will be at a 4 angle Tighten the flowcell release scr...

Page 88: ...the flowcell connections for leaks 4 Check the focus and alignment of the flowcell 5 Check the gains 6 Run a whole blood primer then run controls to verify analyzer performance 7 If the control results are acceptable to the laboratory no additional action is required and normal operation can be resumed Backflushing the Perox Flowcell and Shuttle and Reaction Chambers Materials required Flowcell cl...

Page 89: ...t V24 This is the white fitting at V24 3 3 Fill the cleaning syringe 4 EZ KLEEN and attach it to the white fitting Refill the syringe EZ KLEEN as needed during the following steps 4 Disconnect the sample tubing 5 from the top of the sample syringe 6 and place the sample tubing into a beaker to catch fluid as you backflush the flowcell 5 Gently push the plunger on the cleaning syringe to flush the ...

Page 90: ...BC baso retic Flowcell and Shuttle and Reaction Chambers Materials required Flowcell cleaning kit PN 113 B711 01 EZ KLEENBeaker Deionized water Analyzer mode Ready to Run BIOHAZARD All products or objects that come in contact with human or animal body fluids should be handled before and after cleaning as if capable of transmitting infectious diseases Wear facial protection gloves and protective cl...

Page 91: ...ch the sample tubing 5 to the top of the sample syringe 6 7 Refill the syringe with bleach solution 8 At the Valves window of the Exerciser tab open V9 and then push the syringe to fill RBC chamber 7 with 25 bleach then open V10 to drain Close V9 and V10 Repeat with deionized water 9 Refill the syringe with bleach solution 10 In the Valves window of the Exerciser tab open V12 and then push the syr...

Page 92: ... V23 3 21 Select the Analyzer Status tab to exit the Exerciser 22 Open the Hydraulic Functions tab and then perform one System Wash cycle 23 Run controls to verify system performance Repair and Replacement Replacing the Clot Filters Materials required Lens tissue Replacement clot filter PN 113 3719 01 Time Replacement 5 minutes Checkout 5 minutes Analyzer mode Standby 1 Unscrew the fitting and tub...

Page 93: ...ect the filter adapter fitting and check for dust or debris in the fitting and in the port If air bubbles still persist call Siemens technical support Replacing the Diaphragm Pumps Time Replacement 5 minutes Checkout 15 minutes Materials required 1 DP1 PEROX SHEATH 2 DP2 SHEATH RINSE 3 DP3 SHEATH RINSE 4 DP4 WASH PN 067 B294 04 5 DP5 SHEATH RINSE PN 067 B294 01 Analyzer mode Off REMOVE BOTTLES TO ...

Page 94: ...ion use the backflush procedure Time 10 minutes Analyzer mode Off WARNING The analyzer must be off otherwise personal injury from the needle may occur BIOHAZARD All products or objects that come in contact with human or animal body fluids should be handled before and after cleaning as if capable of transmitting infectious diseases Wear facial protection gloves and protective clothing The operator ...

Page 95: ...ampler modes Check to ensure that there are no leaks and that fluid passes through the filters properly Make sure that the lines do not interfere with autosampler aspirator motion DIRECTION OF FLOW TO COUPLER PLATE TO CENTERING COLLAR OR MANUAL SAMPLER FITTING PN 518 0695 03 FITTING PN 518 0695 13 ...

Page 96: ...nd edition Approved Guideline 1997 Document M29 A National Committee for Clinical Laboratory Standards NCCLS This document contains complete information on user protection and it can be used as reference material for instructions on laboratory safety 1 Remove the old check valve from the Perox line 2 Install the check valve into the line with the direction of flow toward the reagent pump and away ...

Page 97: ...by Blood Body Fluids and Tissue 2nd edition Approved Guideline 1997 Document M29 A National Committee for Clinical Laboratory Standards NCCLS This document contains complete information on user protection and it can be used as reference material for instructions on laboratory safety To remove and replace the front shear valve face or the shear valve rotor In the maintenance procedure Cleaning the ...

Page 98: ...V PN625 0073 02 F2 AC Input L2 3 AB 15 00A T 250V PN625 0073 03 8 00A T 250V PN625 0073 02 F3 Computer Monitor at J24 and J25 20mm 6 30A T 250V PN 625 0127 11 3 15A T 250V PN 625 0127 10 F4 Power Supply PS1 5V 20mm 0 50A T 250V PN625 0127 09 0 25A T 250V PN 625 0127 07 F5 Power Supply PS4 5V Perox Lamp and 15V 20mm 2 00 A T 250V PN 625 0127 04 1 00A T 250V PN 625 0144 03 F6 Power Supply PS2 24V 20...

Page 99: ... mm fuses F3 through F7 1 Loosen the fuse holder by turning it counterclockwise 2 Pull out the fuse holder then remove the faulty fuse 3 Insert the new fuse slide the fuse holder in and tighten it by turning it clockwise 4 Plug in the power cord and set the power switch to I on To replace main fuses F1 and F2 NOTE Both fuses must be replaced 1 With a screwdriver loosen the fuse cap by turning it c...

Page 100: ...e cannot be adjusted to between 3 0 and 4 1 volts If indicated during troubleshooting When to adjust the baseline value After replacing the lamp If the baseline value is 4 2 volts If indicated during troubleshooting WARNING Avoid burns Allow enough time for the hemoglobin lamp to cool After power is shut off wait at least 5 minutes before removing the lamp Materials required ADVIA TESTpoint contro...

Page 101: ...ables Replace the lamp adapter cap and secure it with the screw 6 Turn the analyzer power on Check that there are no error messages on the Status line relating to hemoglobin colorimeter baseline readings 7 At the Operations menu select the Startup tab Select Refresh and check the Hgb baseline transmission value Hgb Trans If the baseline value is not acceptable adjust it to 4 1 8 Run controls to ve...

Page 102: ...ase Transmitted by Blood Body Fluids and Tissue 2nd edition Approved Guideline 1997 Document M29 A National Committee for Clinical Laboratory Standards NCCLS This document contains complete information on user protection and it can be used as reference material for instructions on laboratory safety 1 Remove the tubing from the ports on the valve fitting then carefully unscrew the fittings 2 Remove...

Page 103: ...5 36 Troubleshooting the Analyzer Perox flowcell connections RBC flowcell connections 7 Run controls Check for leaks and verify system performance ...

Page 104: ...tee for Clinical Laboratory Standards NCCLS This document contains complete information on user protection and it can be used as reference material for instructions on laboratory safety 1 Carefully push the wash block 1 down to its fully lowered position 2 Remove the threaded fitting 2 from the probe mount 3 by turning it counterclockwise 3 Carefully slide the probe 4 up and out of the probe mount...

Page 105: ...ait at least 10 minutes CAUTION Fingerprints on the lamp could cause severe degradation in lamp performance DO NOT touch the lamp with your fingers Material required Replacement lamp PN 065 B075 01 Time Replacement 20 minutes Adjustment and checkout 20 minutes Analyzer mode Off wait at least 10 minutes ELECTRICAL WARNING To avoid exposure to shock hazards and or damage to the instrument while perf...

Page 106: ...contact with human or animal body fluids should be handled before and after cleaning as if capable of transmitting infectious diseases Wear facial protection gloves and protective clothing The operator should follow the recommendations to prevent the transmission of infectious agents in health care settings as recommended for potentially infectious specimens in Protection of Laboratory Workers fro...

Page 107: ... sample stream input line 2 and the sheath stream input line 3 from the CFM Allow these lines to hang freely 1 SHEATH NIPPLE 2 SAMPLE NIPPLE 3 SHUTTLE NIPPLE 4 Locate hydraulic valve 24 Unscrew the threaded fitting from the top right side of the valve 5 Release the flowcell by loosening the release knob located on the right of the flowcell adjustment assembly ...

Page 108: ... the flowcell into position 3 Reconnect the hydraulic lines to the CFM Reconnect the flowcell tube assembly fitting to the appropriate hydraulic valve V24 Hand tighten the connection enough to prevent leaks IMPORTANT To avoid incorrect patient data make sure that each hydraulic line is attached to the correct CFM nipple To check analyzer performance 1 Bring the analyzer to the Ready to Run mode th...

Page 109: ...cial protection gloves and protective clothing The operator should follow the recommendations to prevent the transmission of infectious agents in health care settings as recommended for potentially infectious specimens in Protection of Laboratory Workers from Infectious Disease Transmitted by Blood Body Fluids and Tissue 2nd edition Approved Guideline 1997 Document M29 A National Committee for Cli...

Page 110: ...information and laser specifications refer to Safety Information Protecting yourself from lasers 1 Make sure that the analyzer is in the Standby mode 2 Open the optics cover The RBC flowcell is on the left Perox flowcell 1 RBC flowcell 2 3 Disconnect the shuttle line 1 the sample stream input line 2 and the sheath stream input line 3 from the CFM Allow these lines to hang freely 1 SHUTTLE NIPPLE 2...

Page 111: ...hen remove the flowcell Flowcell 1 flowcell release screw 2 6 Hold the flowcell by the red threaded fitting when lifting the flowcell out of the optics assembly CAUTION To avoid getting fingerprints on the glass windows of the flowcell always hold the flowcell by the metal slides ...

Page 112: ...1 Bring the analyzer to the Ready to Run mode then run a saline primer 2 Check the flowcell connections for leaks and verify saline background on the Startup tab 3 At the Procedures menu select the Align Optics tab 4 Select the Info button for help 5 At the Logs menu select Cal Gain Logs and check gain factors Adjust gains if necessary 6 Run a whole blood primer and then run controls to verify ana...

Page 113: ...s recommended for potentially infectious specimens in Protection of Laboratory Workers from Infectious Disease Transmitted by Blood Body Fluids and Tissue 2nd edition Approved Guideline 1997 Document M29 A National Committee for Clinical Laboratory Standards NCCLS This document contains complete information on user protection and it can be used as reference material for instructions on laboratory ...

Page 114: ...andled before and after cleaning as if capable of transmitting infectious diseases Wear facial protection gloves and protective clothing The operator should follow the recommendations to prevent the transmission of infectious agents in health care settings as recommended for potentially infectious specimens in Protection of Laboratory Workers from Infectious Disease Transmitted by Blood Body Fluid...

Page 115: ...rator assembly by aligning the tabs with the appropriate slots Push the block into the assembly and gently slide the block upward until it clicks into place Be careful that you do not pinch the wash or vacuum line during the installation process 7 Check the length of the probe See page 5 3 for instructions 8 Run several saline samples and verify that there are no leaks or bubbles in the sample lin...

Page 116: ...to the first position in the tray and start the autosampler again Cannot Find Videos Cannot find the videos_op videos_op hlp Help file Check to see that the file exists on your disk If it doesn t you need to reinstall it If you get this message when trying to view the videos and you have recently installed a Zip drive the letter assigned to your CD ROM drive may have changed Reinstall the Operator...

Page 117: ... s samples In Customer Parameters you also have the option to set All Complete file size to trigger purge which will automatically purge records when you perform the End of Day procedure Why does the LIS link indicator on the Sample Cont Panel remain green when the host computer cable is disconnected from my PC The bi directional protocol communication link sensor is time delayed After you disconn...

Page 118: ...y blockage using a drill bit or a paper clip Check for blockage or crimps in the perox overflow tube Make sure that the ends of the tubes do not touch the bottom of the overflow bottle nor are they submerged in liquid NOTE If the opening on overflow bottle cap is not large enough and pinches the tubes cut the rubber cap from the outside edge to the inner opening to relieve some of the pressure on ...

Page 119: ...ERATURE OUT OF RANGE BTO TB 30 COMPARISON ERROR MCHC CHCM CHCMCE CC 31 COMPARISON ERROR WBCB WBCP WBC CE WC 32 HGB IRREGULAR FLOW RATE HGBIFR HR 32 HGB POWER LOW HGB PL PH 33 LASER POWER LOW LAS PL PL 33 NO PEROX NRBC LYMPH VALLEY NRPXNV NV 34 PEROX IRREGULAR FLOW RATE PXIFR XR 34 PEROX NO VALLEY PX NV VX 35 PEROX NOISE PX NO NX 36 PEROX POWER LOW PX PL PX 38 PEROX SATURATION PX SAT XS 38 PEROX TE...

Page 120: ...6 2 Flags RETIC SLOPE ERROR RTC SE SE 48 SUSPECT CELLULAR INTERFERENCE NRCELL NC 49 SUSPECT LARGE PLT INTERFERENCE NRLPLT NP 50 SUSPECT LIPID INTERFERENCE NR LPD NL 50 WBC SUBSTITUTION WBCSUB WS 51 ...

Page 121: ...the presence of abnormal cells test results produced by the ADVIA 2120 2120i system are intended for laboratory use only Whenever morphology or quantitative flags are triggered the laboratory before reporting patient results must validate the results and take the appropriate action in accordance with established standard operating procedures Morphology flags appear on the Run Screen and the Review...

Page 122: ... 100WBC or 2 nRBC 200 cells µL PLT CLM NW Clumps Count 150 RBCF RBCF 100 000 cells µL RBCG RBCG 100 000 cells µL Anisocytosis ANISO Definition The Anisocytosis flag is triggered if variation in RBC volume RDW is equal to or greater than 16 The Red Cell Distribution Width RDW parameter is the coefficient of variation of the cell volume distribution on the RBC volume histogram Default trigger values...

Page 123: ...flowcell alignment Atypical Lymphocytes ATYP Definition The presence of atypical lymphocytes is suspected An elevated LUC value on the Perox cytogram may be due to the presence of large atypical lymphocytes blasts and or other large abnormal cells that are peroxidase negative Large lymphocytes are defined as those that are larger than the typical lymph population Blasts are classified independentl...

Page 124: ...stem Related Viral infections Lymphoproliferative disorders RBC nonlysis 1 Check the perox reagents 2 Check the delivery of SHEATH RINSE 3 Check the perox hydraulics and sample delivery 4 Check the perox reaction chamber temperature 5 Check the perox flowcell alignment 6 Check the perox gains Blasts BLASTS Definition The presence of blasts is suspected Blasts are detected in the Blasts area on the...

Page 125: ...that could cause this flag Multiple occurrences of this flag especially for consecutive samples can indicate a system problem However isolated instances of this flag are usually sample related Sample Related System Related Acute leukemias Chronic leukemias Lymphomas Myelofibrosis Refractory anemia with excess blasts RAEB Neonatal samples 1 Check the perox and baso reagents 2 Check the delivery of ...

Page 126: ... Multiple occurrences of this flag especially for consecutive samples can indicate a system problem However isolated instances of this flag are usually sample related Sample Related System Related Sickle cell anemia Iron deficiency anemia Hemolytic anemia Transfusion 1 Check RBC reagents 2 Check RBC hydraulics 3 Check RBC gains 4 Check laser flowcell alignment Hyperchromia HYPER Definition The Hyp...

Page 127: ...t Hypochromia HYPO Definition The Hypochromia flag is triggered if the percentage of cells with low cellular hemoglobin concentration HYPO is equal to or greater than 4 0 The HYPO parameter indicates the percent of cells that have a cellular hemoglobin concentration less than 28 g dL and is derived from the RBC HC histogram Default trigger values for the three severity levels are HYPO 4 0 to 7 9 H...

Page 128: ... present Immature Granulocytes appear in the neutrophil and eosinophil areas on the Perox cytogram and in the mononuclear MN area on the Baso cytogram On the BASO cytogram the eosinophils and neutrophils reside within the Polymorphonuclear PMN area Subtracting the PMN from the sum of the NEUT and EOS provides an estimate of the Immature Granulocytes Default trigger values for the three severity le...

Page 129: ...flag is triggered if the percentage of large platelets LPLT is greater than 10 of the platelet count The LPLT parameter indicates the percent of platelets with volumes greater than 20 fL This parameter is derived from the Platelet Volume histogram based on Integrated Analysis Default trigger values for the three severity levels are LPLT 10 0 to 11 9 LPLT 12 0 to 14 0 LPLT 14 0 The LPLT value is in...

Page 130: ... D is less than 0 15 The Lobularity Index LI is used to set the severity levels for this flag The LI is the PMN peak channel number on the Baso X histogram divided by 14 and it is greater than 1 9 for normal samples Values lower than 1 9 are usually indicative of sample abnormality In samples where a bimodal distribution is not present only PMN populations with PMN peaks greater than channel 20 wi...

Page 131: ...ered if the percentage of red blood cells with higher than normal cell volumes MACRO is equal to or greater than 2 5 The MACRO parameter indicates the percent of red blood cells that have a volume equal to or greater than 120 fL and is derived from the RBC volume histogram Default trigger values for the three severity levels are MACRO 2 5 to 6 4 MACRO 6 5 to 10 5 MACRO 10 5 The MACRO value is inte...

Page 132: ... and is derived from the RBC volume histogram Default trigger values for the three severity levels are MICRO 2 5 to 6 4 MICRO 6 5 to 10 5 MICRO 10 5 The MICRO value is intended for flagging and laboratory purposes only Results Flagged none Possible Causes The following list of sample related causes may not contain all conditions that could cause this flag Multiple occurrences of this flag especial...

Page 133: ... Staining Weak Peroxidase Staining MPO flag Perox Cytogram Baso Cytogram Because PMN NEUT EOS is close to 0 there is no flag By inspection the sum of the events in the NEUT 1 and EOS 2 areas appears approximately equal to the count in the PMN area 3 Perox Cytogram Baso Cytogram Because PMN NEUT EOS is greater than 25 the flag is triggered By inspection the sum of the events in the NEUT 1 and EOS 2...

Page 134: ...d red blood cells or the occurrence of either the Suspect Cellular Interference NRCELL flag or the Suspect Large Platelets NRLPLT flag will trigger the NRBC Morphology flag There is no severity level associated with this flag Possible Causes The following list of sample related causes may not contain all conditions that could cause this flag Multiple occurrences of this flag especially for consecu...

Page 135: ...to the right of the lymphocyte population The number of events obtained from this area is called the Clumps Count The Clumps Count is excluded from the WBCP and differential results There is no severity level associated with this flag Perox Cytogram Normal Sample Perox Cytogram PLT CLM flag 1 PLT Clumps area Results Flagged WBCP PLT PCT MPV and PDW Possible Causes The following list of sample rela...

Page 136: ...an 30fL and refractive indexes greater than 1 400 RBC fragments are excluded from the PLT count and the RBC count There are no severity levels associated with this flag Normal PLT Scatter Cytogram Abnormal PLT Scatter Cytogram 1 RBC Ghost area 2 Platelet area 3 RBC Fragment area NOTE Whenever the ratio of RBC fragments to platelets exceeds 0 25 the system uses the log normal fit calculation to det...

Page 137: ...RBC Ghosts RBCG Definition The presence of RBC ghosts is suspected This flag occurs if the number of events in the RBC Ghost area of the PLT Scatter cytogram is greater than 100 000 cells µL The events counted in this area have refractive indexes lower than 1 350 RBC ghosts are excluded from the PLT count and the RBC count There are no severity levels associated with this flag Normal PLT Scatter C...

Page 138: ... all conditions that could cause this flag Multiple occurrences of this flag especially for consecutive samples can indicate a system problem However isolated instances of this flag are usually sample related Sample Related Hemolysis Cryoglobulins Chylomicrons Pyropoikilocytosis Lipemia ...

Page 139: ...ses appear on the Sample System Flag Analysis panel of the Run Screen Flag Triggering Criteria CBC CBC DIFF CBC DIFF RETIC CBC RETIC RETIC B SUSP BC Events above the upper MN PMN threshold on y axis and in channels 0 to 49 on x axis 5 BIFR BR Baso Flatness 2 5 B NO NB Baso Noise 10 B NV VB 1 BASO d D 0 15 2 Flag is not set if there is WBC agreement no WBC CE flag and NEUT EOS PMN is between 0 and ...

Page 140: ...LT NP LPLT 40 x 103 μL NRPXNV No valley between the NRBC and lymphocyte populations and a reportable NRBC count PLT NO NT 1 LPLT and ANISO flags are triggered any severity level 2 LPLT and MICRO flags are triggered any severity level PLTORN OT Events in the Platelet Origin Noise area are 2 of the total events the PLT cytogram PX NV VX 1 PEROX d D 0 15 2 Flag is not set if there is WBC agreement no...

Page 141: ...here is WBC agreement no WBC CE flag PXTO TX 1 Perox chamber temperature is not between 58 C and 72 1 C 2 Flag is not set if there is WBC agreement no WBC CE flag and NEUT EOS PMN is between 0 and 7 5 RBCIFR RR RBC Flatness 3 2 RTCint CT Platelet threshold below channel 5 RTCADA CA 1 Absorption mode for Gaussian fit is not between channels 6 and 30 2 SD of RETIC Abs histogram over 80 of height 1 4...

Page 142: ...6 RTCSAT CS Saturation cells 10 of gated cells RTC SE SE Slope of negative cell population on absorption axis 0 2 WBC CE WC 1 WBCB WBCP 1 0 x 10 µL when WBCB 2 0 x 10 µL and 10 0 x 10 µL 2 WBCB WBCP 10 of WBCB when WBCB 10 0 x 10 µL 3 WBCB WBCP 20 WBCB when WBCB 2 0 x 10 µL 4 WBCB count is not flagged if the PX NV or PX NO flags are set WBCSUB WS If WBCB is flagged but WBCP is not the WBCP value i...

Page 143: ...creen When histogram analysis is applied the Baso Count Suspect region is located above channel 21 on the y axis and in channels 0 and 49 on the x axis Baso Cytogram cluster analysis Baso Cytogram histogram analysis 1 Basophils 2 BASO Suspect 3 Baso Saturation Results Flagged BASO BASO LYMPH LYMPH LUC LUC A four part WBC differential basophils excluded is reported with the measured BASO values dis...

Page 144: ...el Baso flow rate is evaluated in terms of the cell counting rate Flow Uniformity Sum of the Squared Differences 9 x Mean Cell Counting Rate The flag is triggered if this value is greater than 2 5 The BASO Rate Histogram displays the arrival rate of cells in the baso channel Normal BASO Rate Histogram BIFR BASO Rate Histogram Results Flagged WBC WBCB BASO BASO Corrective Action 1 Check baso reagen...

Page 145: ...le system flag WBCB is reported as the WBC count for samples with a WBC lower than 1 0 x 10 μL The Noise area 1 of the Baso cytogram is determined by cluster analysis If histogram analysis is applied the Noise area 2 is located between channels 0 and 8 on the y axis Cluster Analysis 1 noise cluster Histogram Analysis 2 noise area Results Flagged WBC WBCB BASO BASO Corrective Action Multiple occurr...

Page 146: ...clear PMN populations in the Baso cytogram The B NV VB flag is not triggered if agreement between the baso and perox results is indicated by both the following conditions WBCB and WBCP agree within specified limits No WBC CE flag NEUT EOS PMN is between 0 and 7 5 Separation of the MN and PMN populations along the x axis of the Baso cytogram is evaluated by the relative depth of the valley between ...

Page 147: ...k sheath delivery 5 Check RBC Baso Retic flowcell alignment Aged blood Absolute lymphocytosis Immature granulocytes Unsegmented neutrophils bands Baso Saturation B SAT BS Definition The Baso Saturation flag is triggered if the number of events in the Saturation area of the Baso cytogram is greater than 2 5 of the baso signals This flag is not triggered if WBCB and WBCP agree within specified limit...

Page 148: ...ed The following list of sample related causes may not contain all conditions that could cause this flag There is no intention to associate the flag with specific diagnoses System Related Sample Related 1 Check baso reagents 2 Check the pressure and vacuum readings 3 Check sheath delivery 4 Check baso hydraulics 5 Check RBC Baso Retic flowcell alignment Leukemia high WBC Fungal infections Cell clu...

Page 149: ...onsecutive samples can indicate a system problem However isolated instances of this flag are usually sample related The following list of sample related causes may not contain all conditions that could cause this flag There is no intention to associate the flag with specific diagnoses System Related Sample Related 1 If another flag appears along with the comparison error troubleshoot that error fi...

Page 150: ...tem problem However isolated instances of this flag are usually sample related The following list of sample related causes may not contain all conditions that could cause this flag There is no intention to associate the flag with specific diagnoses System Related Sample Related 1 If the Perox Noise PX NO and or No Valley Perox PX NV sample system flags are triggered troubleshoot the perox channel ...

Page 151: ...lag is triggered if the HGB baseline transmission is less than 2 5 or greater than 4 1 Results Flagged HGB MCH and MCHC Corrective Action 1 Adjust the Hgb baseline 2 Perform the rinse reagent check 3 Replace the Hgb lamp Laser Power Low LAS PL PL Definition The Laser Power Low flag is triggered if the laser light intensity in the RBC Baso Retic channel is less than 150 Results Flagged RBC HCT MCV ...

Page 152: ...ASO LUC LUC The green circles in both the NRBC Enumeration histogram and Noise lymph histogram below show no valley separating lymphocyte events from the nRBC population The red arrow identifies the nRBC events NRBC Enumeration Histogram Noise Lymph Histogram Perox Irregular Flow Rate PXIFR XR Definition The Perox Irregular Flow rate flag is triggered if the cell counting rate is erratic because o...

Page 153: ...Perox No Valley flag is triggered if there is no valid separation between the noise and lymphocyte populations in the Perox cytogram The separation of the noise and lymphocyte populations along the y axis of the Perox cytogram is evaluated by the relative depth of the valley PEROX d D between the two populations In normal samples PEROX d D is greater than 0 15 This flag is triggered if PEROX d D i...

Page 154: ... There is no intention to associate the flag with specific diagnoses System Related Sample Related 1 Check perox reagents 2 Check peroxidase hydraulics and sample delivery 3 Check delivery of SHEATH RINSE 4 Check PEROX SHEATH delivery 5 Check the pressure and vacuum readings 6 Check the perox reaction chamber temperature 7 Check perox flowcell alignment 8 Check perox gains Neonatal samples Aged bl...

Page 155: ...ise area is located in the lower left corner of the Perox cytogram 1 Results Flagged WBCP NEUT NEUT LYMPH LYMPH MONO MONO EOS EOS LUC and LUC Corrective Action Multiple occurrences of this flag especially for consecutive samples can indicate a system problem However isolated instances of this flag are usually sample related The following list of sample related causes may not contain all conditions...

Page 156: ... Perox Power Low PX PL PX Definition The Perox Power Low flag is triggered if the tungsten halogen light intensity in the Perox channel is less than 90 Results Flagged WBCP NEUT NEUT LYMPH LYMPH MONO MONO EOS EOS LUC and LUC Corrective Action 1 Perform the sheath reagent check 2 Check perox lamp alignment 3 Replace the tungsten halogen lamp Perox Saturation PX SAT XS Definition The Perox Saturatio...

Page 157: ...roblem However isolated instances of this flag are usually sample related The following list of sample related causes may not contain all conditions that could cause this flag There is no intention to associate the flag with specific diagnoses System Related Sample Related 1 Check perox reagents 2 Check peroxidase hydraulics and sample delivery 3 Check delivery of SHEATH RINSE 4 Check PEROX SHEATH...

Page 158: ... NEUT NEUT LYMPH LYMPH MONO MONO EOS EOS LUC and LUC Corrective Action 1 Check the perox reaction chamber temperature 2 Check the reaction chamber temperature controller including the electrical connection Platelet Noise PLT NO NT Definition The PLT NO flag indicates the presence of sample interferences such as microcytes or RBC fragments that could be counted as large platelets The PLT NO flag is...

Page 159: ...he PLTORN flag is triggered when the number of events in the Platelet Origin Noise area of the PLT cytogram exceeds 2 of the total number of events Normal Sample PLTORN Flag PLT Cytogram PLT Cytogram 1 Platelet Origin Noise area 2 RBC Ghosts area Results Flagged RBC MCV HCT MCH MCHC CH CHCM CHDW RDW HDW PLT PCT MPV and PDW Corrective Action Multiple occurrences of this flag especially for consecut...

Page 160: ...CH MCHC CHCM CH CHDW RDW HDW PLT MPV PDW Corrective Action 1 Check RBC reagents 2 Check RBC hydraulics 3 Check sheath delivery 4 Check the pressure and vacuum readings A partially clogged RBC baso retic sheath filter can produce a distinctive ski slope effect on the RBC Baso and Retic flow rate histograms Replace the sheath filter RBC Rate Baso Rate Retic Rate Retic Plt Interference Error RTCint C...

Page 161: ...n histogram is above channel 30 Retic Abs The SD of the absorption histogram above 80 of the original histogram height is greater than 1 4 Retic Abs The measured mean absorption minus the theoretical absorption is greater than 30 Retic Abs F Results Flagged RETIC RETIC CHg CHr CHCMg CHCMr CHDWr CHDWg MCVg MCVr RDWg RDWr Corrective Action Multiple occurrences of this flag especially for consecutive...

Page 162: ...cillation mode hopping Laser oscillation also called mode hopping is defined as a change in the laser output frequency during the analysis Typically this condition triggers three sample system flags RETIC Fit Suspect flag RTC FS is triggered due to the bimodal absorption populations that appear on the RETIC Scatter Absorption cytogram 1 and the RETIC Absorption histogram 2 RETIC Absorption Distrib...

Page 163: ...cific diagnoses Transfusion Sickle cell anemia Excessive NRBCs Retic Irregular Flow Rate RTCIFR CR Definition The Retic Irregular Flow Rate flag is triggered if the cell counting rate is erratic due to a hydraulic disturbance in the retic channel Retic flow rate is evaluated in terms of the cell counting rate Flow Uniformity Sum of the Squared Differences 9 x Mean Cell Counting Rate The flag is tr...

Page 164: ... area of the Retic Scatter Abs cytogram is located in absorption channels 1 through 3 Typically an excessive number of events detected in this area is due to unsphered cells or improperly set gains Normal Retic Scatter Abs Cytogram 1 Noise Origin area Results Flagged RETIC RETIC CHg CHr CHCMg CHCMr CHDWr CHDWg MCVg MCVr RDWg RDWr Corrective Action Multiple occurrences of this flag especially for c...

Page 165: ...for consecutive samples can indicate a system problem However isolated instances of this flag are usually sample related The following list of sample related causes may not contain all conditions that could cause this flag There is no intention to associate the flag with specific diagnoses System Related Sample Related 1 Insufficient sample 2 Incorrect open tube sampler probe length 3 Replace the ...

Page 166: ...te the flag with specific diagnoses System Related Sample Related 1 Check delivery of the sheath reagent 2 Check delivery of SHEATH RINSE 3 Check the RBC Baso Retic hydraulics 4 Check the retic hydraulics 5 Check retic gains Immature reticulocytes or neonatal NRBCs High WBCs Retic Slope Error RTC SE SE Definition The Retic Slope Error flag is triggered if the slope of the negative cell population ...

Page 167: ... Interference NRCELL NC Definition The Suspect Cellular Interference flag is triggered by of the possible presence of unlysed red blood cells The flag is raised when the Peroxidase channel WBC count WBCP is greater than the Basophil Lobularity WBC count WBCB by more than the specified limit Results Flagged NRBC NRBC WBC NEUT NEUT LYMPH LYMPH MONO MONO EOS EOS BASO BASO LUC LUC Both the NRBC Enumer...

Page 168: ...MPH MONO MONO EOS EOS BASO BASO LUC LUC NRBC Enumeration Histogram Large platelets may obscure the nRBC population as shown to the left Suspect Lipid Interference NR LPD NL Definition The Suspect Lipid Interference flag is triggered if the number of signals in the noise region of the Basophil Lobularity Channel exceeds a specified limit when the system reports an NRBC count The NR LPD flag is trig...

Page 169: ...rules for CBC DIFF samples are as follows WBCB is reported as the WBC count if there is no BASO Noise B NO or BASO Saturation B SAT flag If WBCB is flagged with NB or BSAT then WBCP is substituted as the WBC count if the WBCP is not flagged with No Valley Perox PX NV Perox Saturation PX SAT Noise Perox PX NO If both WBCB and WBCP are flagged then WBCB is flagged and reported as the WBC count If WB...

Page 170: ...Status Line messages 7 1 Status Line Messages 3 2 3 4 4 5 6 8 6 9 6 A 7 B 39 C 42 D 46 E 47 F 49 G 49 H 50 J 58 K 58 L 58 M 59 N 60 O 66 P 67 Q 79 R 79 S 87 ...

Page 171: ...7 2 Status Line messages T 93 U 94 V 96 W 98 X 99 Y 99 Z 99 ...

Page 172: ...he data back up or export the files before deleting Disk Space Used Stop Disk space used has risen to the level specified as the stop criterion and the autosampler has halted If stop alarm criteria are not configured the default level value is set to 98 Corrective Action Increase available disk space by deleting data from any of these files Raw Data files Export files Sample Results use Customize ...

Page 173: ...ure leak Check for crimped or disconnected hydraulic or pneumatic lines Straighten or reconnect lines as necessary IMPORTANT If problems persist Call Siemens Service for assistance Further corrective action must be taken by Siemens service personnel only 4 4 Key Not Found The Control Dictionary or the Alarm Dictionary is empty If the Alarm Dictionary is empty sample system flags will appear as exc...

Page 174: ...ure leak Check for crimped or disconnected hydraulic or pneumatic lines Straighten or reconnect lines as necessary 40 PSI Out of Range Stop System pressure is out of range The system has stopped because the pressure has reached a critical level that may affect the integrity of sample results and damage the system Possible Cause 1 40 PSI pressure gauge is out of range Corrective Action Check the 40...

Page 175: ... gauge is out of range Corrective Action Check the 5 PSI gauge and adjust the regulator if necessary Setpoint 5 PSI 0 5 2 Pressure leak Check for crimped or disconnected hydraulic or pneumatic lines Straighten or reconnect lines as necessary IMPORTANT If problems persist Call Siemens Service for assistance Further corrective action must be taken by Siemens service personnel only 8 80 Conflict A co...

Page 176: ...he analyzer Analyzer Not Connected The computer has not connected with the analyzer Possible Cause 1 The analyzer is not on Corrective Action Select On at the analyzer touchpad 2 Faulty or disconnected Ethernet cable from the analyzer J2 Workstation connection to the computer Verify that the Ethernet cable connection is secure Replace if necessary 3 Faulty analyzer CPU board or network interface P...

Page 177: ...Reset Required A critical system failure has occurred and an analyzer reset is required Possible Cause Potential hardware failure associated with at least one of these components Motor node pressure node parallel node switch indicator or selector valve Corrective Action 1 Reset the analyzer by selecting Utilities Exerciser Indicators Analyzer Reset 2 After about 1 minute if the status line does no...

Page 178: ...analyzer touchpad e If the problem persists call Siemens Service for assistance Anisocytosis Alarm The number of consecutive occurrences of this condition has met the criterion specified for an alarm message The specified alarm criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Alarm Criteria is automatically reset Anisocytosis Stop T...

Page 179: ...ties menu Hydraulic Functions tab Needle Rinse 7 Bent or damaged needle Replace the needle Follow the steps in Replacing the Sampler Needles 8 Faulty Conductivity Detector Contact your Siemens Field Service representative for assistance Aspiration Failed Probe Clog Stop Conductivity detectors did not detect a sample within the 20 seconds of aspiration The number of consecutive occurrences of this ...

Page 180: ...r messages are triggered Also the green ready to aspirate light is off Possible Cause 1 Aspiration is paused while the following menus or tabs are selected Reagent Installation Backup Restore System Setup Tools Modify or with the triggering of some error messages Corrective Action Select any tab or menu button other than the ones identified at left under Possible Cause 2 Critical system error occu...

Page 181: ...Rinse started on schedule Auto Rinse Canceled The System canceled the scheduled Auto Rinse in accordance with user cancellation Auto Rinse Missed The scheduled Auto Rinse was missed and did not occur while the Exerciser or System Setup tab was open Auto Standby Started The Auto Standby started on schedule Auto Standby Canceled The System canceled the scheduled Auto Standby in accordance with user ...

Page 182: ...hile the Exerciser or System Setup tab was open Auto System Wash Exiting Standby The System moved from Standby to Ready to Run enabling the scheduled Auto System Wash Auto System Wash Canceled The System canceled the scheduled Auto System Wash in accordance with user cancellation Auto Wash Started The Auto System Wash started on schedule Auto Wash is Due Will Start at End of Run The scheduled Auto...

Page 183: ...alculated from installation date and open container stability Corrective Action Replenish expired reagents and update the Reagent Installation window Go to Logs Reagent Log Reagent Installation autoRETIC Reagent Low Alarm The number of consecutive occurrences of this condition has met the criterion specified for an alarm message indicating that the reagent level is low The specified alarm criterio...

Page 184: ...ation error Corrective Action Calibrate mixer aspirate position again 2 Autosampler CPU board failed to store calibration data in flash memory Replace autosampler CPU board Autosampler Bad Mixer Shuttle Cal Mixer shuttle index calibration failed in diagnostic mode Exerciser tab CAUTION Call Siemens Service for assistance Only Siemens Service personnel are authorized to take these corrective action...

Page 185: ...spirate position Autosampler Car Alignment Error Reset Autosampler The autosampler car is out of alignment A reset is required Corrective Action 1 Open the autosampler access door 2 Close the autosampler access door The autosampler resets 3 If the problem persists call Siemens Service for assistance Autosampler Car Initialization Failed Reset Autosampler The autosampler car has failed to initializ...

Page 186: ...put shuttle Check for binding and excessive drag when moving the rack c Perform the mixer alignment procedure as necessary Autosampler Car Motion Denied To prevent the collision of autosampler components the system did not execute the command to move the autosampler car Autosampler Car Motion Denied Reset Autosampler The autosampler attempted an inappropriate car motion An autosampler reset is req...

Page 187: ...b Close the autosampler access door The autosampler will reset 2 Critical Sampler Error Full Reset is required a At the analyzer touchpad select Off b Wait about 1 minute and select On to restart the analyzer c If the problem persists call Siemens Service for assistance 3 Air lines supplying the centering collar are pinched a Open the autosampler access door b Check for kinked or pinched tubing Re...

Page 188: ...osampler access door The autosampler will reset d If the problem persists call Siemens Service for assistance 4 Faulty output queue sensor or sensor wiring Call Siemens Service for assistance Autosampler Collar Failed to Extend Reset Autosampler The autosampler centering collar failed to extend properly Possible Cause 1 Critical Sampler Error Partial Reset is required Corrective Action a Open the ...

Page 189: ...pler access door b Close the autosampler access door The autosampler will reset 2 Critical Sampler Error Full Reset is required a At the analyzer touchpad select Off b Wait about 1 minute and select On to restart the analyzer c If the problem persists call Siemens Service for assistance 3 Air lines supplying the centering collar are pinched a Open the autosampler access door b Check for kinked or ...

Page 190: ...estart the analyzer 3 If the problem persists call Siemens Service for assistance Autosampler Diagnostic Mode Not In Effect The analyzer sent a diagnostic command to the autosampler while the autosampler was in operating mode Corrective Action 1 Open the Autosampler window of the Exerciser tab 2 Select Enter Diagnostic Mode Autosampler Eject Rack Failed The autosampler failed to respond to the eje...

Page 191: ...xperienced a software error and must be reset Corrective Action 1 At the analyzer touchpad select Off 2 Wait about 1 minute and pr select On to restart the analyzer 3 If the problem persists call Siemens Service for assistance Autosampler Extra Rack Ejected This message is for your information only If the message persists call Siemens Service for assistance Autosampler Failure Stop There has been ...

Page 192: ... example a position mixer command could have been sent before a mixer initialization Corrective Action Call Siemens Service for assistance Autosampler Input Queue Jammed Possible Cause 1 Rack has jammed the leading edge of input queue blade Corrective Action Remove and reset rack 2 Queue pan motion is impeded Check for foreign objects in input queue pan 3 Feed motor failed Call Siemens Service for...

Page 193: ... for foreign objects 3 Feed motor has failed Call Siemens Service for assistance Autosampler Input Queue Motion Failed Reset Autosampler The autosampler input queue failed to move properly An autosampler reset is required Possible Cause 1 Rack has jammed the leading edge of the input queue blade Corrective Action a Remove and replace rack b Select Start on the analyzer touchpad The autosampler res...

Page 194: ...ernal Communication Failure During normal operation the autosampler detected an internal software level communication failure This caused the autosampler to stop operation Corrective Action 1 At the analyzer touchpad select Off 2 Wait about 1 minute and select On to restart the analyzer 3 If the problem persists call Siemens Service for assistance Autosampler Invalid Operation Mode Reset Autosampl...

Page 195: ...o prevent the collision of autosampler components the system did not execute the requested action Autosampler Mixer Failed The autosampler mixer failed and may be defective Corrective Action 1 On the analyzer touchpad select Off 2 Wait about 1 minute and select On to restart the analyzer 3 If the problem persists call Siemens Service for assistance Autosampler Mixer Lost Steps Reset Autosampler Th...

Page 196: ...d 2 Wait about 1 minute and select On to restart the analyzer 3 If the problem persists call Siemens Service for assistance Autosampler Mixer Motion Failed Reset Autosampler The autosampler failed to perform a routine mixer motion during normal rack processing A reset is required Possible Cause 1 Critical autosampler error Corrective Action a At the analyzer touchpad select Off b Wait about 1 minu...

Page 197: ...s failed to execute a command to move and must be reset Corrective Action 1 At the analyzer touchpad select Off 2 Wait about 1 minute and select On to restart the analyzer 3 If the problem persists call Siemens Service for assistance Autosampler Motion Request Failed Reset Autosampler The autosampler failed to perform a requested motion and might be defective An autosampler reset is required Corre...

Page 198: ...sists select Off on the analyzer touchpad d Wait about 1 minute and select On to restart the analyzer e If the problem persists call Siemens Service for assistance 2 40 PSI line is out of range a Check pressure and adjust if necessary b Check for pinched air lines supplying needle cylinder c On the analyzer touchpad select Off d Wait about 1 minute and select On to restart the analyzer e If the pr...

Page 199: ...3 Needle is bent Replace needle 4 Needle sensor failed Call Siemens Service for assistance Autosampler Needle Jammed The needle failed to extend or retract during sample aspiration Possible Cause 1 40 PSI line out of range Corrective Action a Check pressure and adjust if necessary b Check for pinched air lines supplying needle cylinder c At the analyzer touchpad select Off d Wait about 1 minute an...

Page 200: ...g clip Autosampler Operating Mode Not in Effect The autosampler is not in operating mode Corrective Action 1 Open the Autosampler window of the Exerciser tab 2 Exit the Exerciser tab by opening another tab Autosampler Output Queue Full Possible Cause 1 Output queue and or output shuttle are full Corrective Action Remove racks from output queue and or output shuttle 2 Output queue sensor ribbon cab...

Page 201: ...autosampler components the system did not execute the command to move the autosampler output queue Autosampler Output Queue Motion Failed The autosampler output queue failed to move properly Possible Cause 1 Leading edge of the output queue blade has speared a rack Corrective Action a Remove racks from output queue and shuttle b Select Start at the analyzer touchpad The autosampler resumes operati...

Page 202: ...e output shuttle Autosampler Pushpin Extend Denied To prevent the collision of autosampler components the system did not execute the command to extend the autosampler pushpin Autosampler Pushpin Motion Denied Reset Autosampler The autosampler attempted an inappropriate pushpin motion An autosampler reset is required Corrective Action 1 Select Off at the analyzer touchpad 2 Wait about 1 minute and ...

Page 203: ...m of the mixer a Check rack position in mixer Adjust if necessary b If the problem persists call Siemens Service for assistance 4 Faulty output queue sensor or wiring Call Siemens Service for assistance Autosampler Pushpin Failed to Retract Reset Autosampler The autosampler pushpin failed to retract properly Possible Cause 1 Pushpin is jammed Corrective Action a Open the autosampler access door b ...

Page 204: ...e personnel are authorized to take this corrective action b Check output queue sensor and sensor wiring 2 Pushpin catches on bottom surface of mixer extrusion a Check and adjust rack position in mixer CAUTION Call Siemens Service for assistance Only Siemens Service personnel are authorized to take this corrective action b Check output queue sensor and sensor wiring Autosampler Rack Index Failed Re...

Page 205: ...osition number for the current tube position Possible Cause 1 Rack barcode label improperly placed obscured or absent Corrective Action Make sure the barcode label is correctly placed on the rack is clean and meets specifications 2 Window of barcode reader is dirty or line of sight is obstructed a Clean barcode reader window b Make sure there is no visual obstruction between the barcode reader win...

Page 206: ...ssible Cause 1 Faulty barcode reader cabling Corrective Action a At the analyzer touchpad select Off b Wait about 1 minute and select On to restart the analyzer c If the problem persists call Siemens Service for assistance 2 Faulty barcode reader See 1a b c Autosampler Shuttle Gate Open Input queue cannot advance the rack because the shuttle gate is not closed Possible Cause 1 Shuttle gate only pa...

Page 207: ...Push tube down b At the analyzer touchpad select Start Stop to continue operations 2 Tube is too long a Remove tube from rack and aspirate manually b At the analyzer touchpad select Start Stop to continue operations Autosampler Startup Complete The autosampler has successfully completed the startup process Autosampler Unexpected Car Position Reset Autosampler The autosampler car is not in the prop...

Page 208: ...e host is incorrect Corrective Action Call Siemens Service for assistance Bad Analysis for Y Message 10402 The format of the received workorder is incorrect The workorder cannot be created Corrective Action Call Siemens Service for assistance Bad Mixer Cal Value Reset Autosampler Mixer aspirate calibration failed while the system was in diagnostic mode Exerciser The corrective actions for this err...

Page 209: ...th the Stop Criteria is reset when the Start Stop button is selected BASO Irregular Flow Rate Alarm The number of consecutive occurrences of this condition has met the criterion specified for an alarm message The specified alarm criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Alarm Criteria is automatically reset BASO Irregular Flo...

Page 210: ...criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria Reagent Conditions Corrective Action The alarm counter is automatically reset after reagents are replenished and the Reagent Installation window is updated Go to Logs Reagent Log Reagent Installation BASO Saturation Alarm The number of consecutive occurrences of this condition has met the criterion specified for an ...

Page 211: ...nces of this condition has met the criterion specified for an alarm message The specified alarm criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Alarm Criteria is automatically reset Blasts Stop The number of consecutive occurrences of this condition has met the criterion specified for a stop message The autosampler halts at the sam...

Page 212: ...e Check for a crimped waste line on the waste container Straighten or reconnect lines as necessary IMPORTANT If problems persist Call Siemens Service for assistance Further corrective action must be taken by Siemens service personnel only Communications Error with Analyzer Software communication error between the computer and the analyzer Possible Cause 1 Internal software corruption Corrective Ac...

Page 213: ...same time the stop message occurs The specified stop criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Stop Criteria is reset when the Start Stop button is selected Comparison Error WBCB WBCP Alarm The number of consecutive occurrences of this condition has met the criterion specified for an alarm message The specified alarm criterio...

Page 214: ...eld is clogged Replace the vacuum pump filter 4 Compressor failure Call Siemens service for assistance Control Out of Range Alarm One or more control samples have yielded out of range test results The number of consecutive occurrences of this condition has met the criterion specified for an alarm message The specified alarm criterion is user definable in the Customize Menu System Setup Alarm Stop ...

Page 215: ...the analyzer touchpad c Select CTRL ALT DELETE and log back onto the system to restart the software d Restart the analyzer by selecting On at the analyzer touchpad D Data Manager Critical Error An internal software communication error has triggered a high level Data Manager error Corrective Action 1 Select Shut Down ADVIA at the Log On Off window 2 Select CTRL ALT DELETE and log back onto the syst...

Page 216: ...nt date is beyond the DEFOAMER reagent expiration date as determined by encoded reagent container barcode label or as calculated from installation date and open container stability Corrective Action Replenish expired reagents and update the Reagent Installation window Go to Logs Reagent Log Reagent Installation DEFOAMER Reagent Low Alarm The number of consecutive occurrences of this condition has ...

Page 217: ... to Logs Reagent Log Reagent Installation Select Start Stop to continue the run EZ KLEEN Reagent Expired Present date is beyond the EZ KLEEN reagent expiration date as determined by encoded reagent container barcode label or as calculated from installation date and open container stability Corrective Action Replenish expired reagents and update the Reagent Installation window Go to Logs Reagent Lo...

Page 218: ...ed To restore the Oen cnf file select Other Utilities and restore dictionaries File Not In Modifiable File List Updating This message appears when a file is created through the Format window The file is then stored in the database Corrective Action No action is required G GETEQUAL This control is not defined in the Control Dictionary Corrective Action Define the control in the Control Dictionary G...

Page 219: ...art the analyzer by selecting On at the analyzer touchpad 2 Faulty power supply fuse cable HGB Interface Node Board or Can Bus Scrambler Board Call Siemens Service for assistance HGB Concentration Variance Alarm The number of consecutive occurrences of this condition has met the criterion specified for an alarm message The specified alarm criterion is user definable in the Customize Menu System Se...

Page 220: ...efinable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Alarm Criteria is automatically reset HGB Power Low Stop The number of consecutive occurrences of this condition has met the criterion specified for a stop message The autosampler halts at the same time the stop message occurs The specified stop criterion is user definable in the Customize Menu System S...

Page 221: ... after reagents are replenished and the Reagent Installation window is updated Go to Logs Reagent Log Reagent Installation Hyperchromia Alarm The number of consecutive occurrences of this condition has met the criterion specified for an alarm message The specified alarm criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Alarm Criteria...

Page 222: ... The counter associated with the Alarm Criteria is automatically reset Immature Granulocytes Stop The number of consecutive occurrences of this condition has met the criterion specified for a stop message The autosampler halts at the same time the stop message occurs The specified stop criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with th...

Page 223: ... for assistance Initialization Failed During Communication from Analyzer Software communication error Corrective Action Follow these steps to exit the ADVIA 2120 2120i software and then restart 1 Select Shut Down ADVIA at the Log On Off window 2 Select CTRL ALT DELETE and log back onto the system to restart the software If the problem persists call Siemens Service for assistance Initialization Fai...

Page 224: ...e for assistance Initialization Failed During OMF File Download Software communication error Corrective Action Follow these steps to exit the ADVIA 2120 2120i software and then restart 1 Select Shut Down ADVIA at the Log On Off window 2 Select CTRL ALT DELETE and log back onto the system to restart the software If the problem persists call Siemens Service for assistance Initialization Failed Waiti...

Page 225: ...Action Follow these steps to exit the ADVIA 2120 2120i software and then restart 1 Select Shut Down ADVIA at the Log On Off window 2 Select CTRL ALT DELETE and log back onto the system to restart the software If the problem persists call Siemens Service for assistance Invalid Configuration Mandatory Field Missing The configuration file is incorrect A mandatory field is missing Corrective Action On...

Page 226: ...WBC has incorrect or undefined values in the analyzer The sample will not be transmitted to the host Corrective Action Verify that the result is composed of four results of one character each Invalid System Number The computer system number as it applies to the host is improperly defined or undefined in the parameter file Corrective Action Call Siemens Service for assistance Invalid Test Code in R...

Page 227: ... of consecutive occurrences of this condition has met the criterion specified for an alarm message The specified alarm criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Alarm Criteria is automatically reset Laser Power Low Stop The number of consecutive occurrences of this condition has met the criterion specified for a stop message ...

Page 228: ...ustomize Menu System Setup Alarm Stop Criteria The counter associated with the Alarm Criteria is automatically reset Macrocytosis Stop The number of consecutive occurrences of this condition has met the criterion specified for a stop message The autosampler halts at the same time the stop message occurs The specified stop criterion is user definable in the Customize Menu System Setup Alarm Stop Cr...

Page 229: ...tosampler halts at the same time the stop message occurs The specified stop criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Stop Criteria is reset when the Start Stop button is selected MPO Deficiency Alarm The number of consecutive occurrences of this condition has met the criterion specified for an alarm message The specified ala...

Page 230: ...a is reset when the Start Stop button is selected No Cell Cluster Fit on PEROX Alarm The number of consecutive occurrences of this condition has met the criterion specified for an alarm message The specified alarm criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Alarm Criteria is automatically reset No Cell Cluster Fit on PEROX Stop...

Page 231: ...ve occurrences of this condition has met the criterion specified for an alarm message The specified alarm criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Alarm Criteria is automatically reset No PEROX Noise Lymph Valley Stop The number of consecutive occurrences of this condition has met the criterion specified for a stop message T...

Page 232: ... host computer or at the Data Manager 2 A work order has not been transmitted for the current patient sample Check if problem exists at the host computer If problem is not at the host level call Siemens Service for assistance No Workorder Stop No workorder received for current patient sample The number of consecutive occurrences of this condition has met the criterion specified for a stop message ...

Page 233: ... the Stop Criteria is reset when the Start Stop button is selected Noise PEROX Alarm The number of consecutive occurrences of this condition has met the criterion specified for an alarm message The specified alarm criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Alarm Criteria is automatically reset Noise PEROX Stop The number of co...

Page 234: ...a is automatically reset Nucleated Red Blood Cells Stop The number of consecutive occurrences of this condition has met the criterion specified for a stop message The autosampler halts at the same time the stop message occurs The specified stop criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Stop Criteria is reset when the Start St...

Page 235: ...y Port Configuration 4 Verify that the Inst1 device is listed as ADVIA 2120 2120i and correct it if necessary 5 Check the communications port where the problem occurs COM 1 or MCA Serial board If the system is using the Host Spec 79 Network connection Siemens Field Service personnel should make sure the Host name and IP address are specified correctly 1 Use Windows Explorer to open the directory C...

Page 236: ...nd the green ready to aspirate light is still off follow these steps to exit the ADVIA 2120 2120i software turn off the analyzer and then restart i Select Shut Down ADVIA in the Log On Off window ii Select Off at the analyzer touchpad iii Select CTRL ALT DELETE and log back onto the system to restart the software iv Restart the analyzer by selecting On at the analyzer touchpad 2 Faulty power suppl...

Page 237: ...e to Aspiration Paused Corrective Action Increase available patient result database space by deleting data from the sample results file Use Customize System Setup Tools Modify End of Day IMPORTANT Deleting files permanently erases data If you need an electronic copy of the data back up the files before deleting Patient Result Database Is Nearly Full The patient result database has reached the leve...

Page 238: ...eagent Log Reagent Installation Select Start Stop to continue the run PEROX 1 Reagent Expired Present date is beyond the PEROX 1 reagent expiration date as determined by encoded reagent container barcode label or as calculated from installation date and open container stability Corrective Action Replenish expired reagents and update the Reagent Installation window Go to Logs Reagent Log Reagent In...

Page 239: ... Go to Logs Reagent Log Reagent Installation PEROX 2 Reagent Low Alarm The number of consecutive occurrences of this condition has met the criterion specified for an alarm message indicating that the reagent level is low The specified alarm criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria Reagent Conditions Corrective Action The alarm counter is automatically rese...

Page 240: ...t Installation window is updated Go to Logs Reagent Log Reagent Installation PEROX Irregular Flow Rate Alarm The number of consecutive occurrences of this condition has met the criterion specified for an alarm message The specified alarm criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Alarm Criteria is automatically reset PEROX Irr...

Page 241: ... not in home position Corrective Action a Reset the analyzer by selecting Utilities Exerciser Indicators Analyzer Reset b After about 1 minute if the status line does not display Ready to Run and the green ready to aspirate light is still off follow these steps to exit the ADVIA 2120 2120i software turn off the analyzer and then restart i Select Shut Down ADVIA at the Log On Off window ii Select O...

Page 242: ...EROX SHEATH syringe pump not in home position failed to respond or a transmission error occurred Possible Cause 1 PEROX SHEATH syringe pump not moving or not in home position Corrective Action a Reset the analyzer by selecting Utilities Exerciser Indicators Analyzer Reset b After about 1 minute if the status line does not display Ready to Run and the green ready to aspirate light is still off foll...

Page 243: ...d open container stability Corrective Action Replenish expired reagents and update the Reagent Installation window Go to Logs Reagent Log Reagent Installation PEROX SHEATH Reagent Low Alarm The number of consecutive occurrences of this condition has met the criterion specified for an alarm message indicating that the reagent level is low The specified alarm criterion is user definable in the Custo...

Page 244: ...e in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Stop Criteria is reset when the Start Stop button is selected Platelet Noise Alarm The number of consecutive occurrences of this condition has met the criterion specified for an alarm message The specified alarm criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter asso...

Page 245: ...m internal temperature exceeds the maximum limit a Shut down the system b Allow the system to cool down for 15 minutes c Restart the system d If the problem persists call Siemens Service for assistance 3 Fans are not functioning properly Verify fan operation If you suspect that a fan is not working properly call Siemens Service for assistance 4 Faulty power pack temperature sensor Call Siemens Ser...

Page 246: ...stance Printer Busy Printing Aborted The printer was busy when a printout was requested Corrective Action Restart the printout when the printer is free Printer Not Defined The printer is not defined in the Port Configuration window Corrective Action Correct or enter the printer definition in the Port Configuration window Select Customize menu System Setup Tools Modify Port Configuration Printer No...

Page 247: ...ber of consecutive occurrences of this condition has met the criterion specified for a stop message The specified stop criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Stop Criteria is reset when the Start Stop button is selected Corrective Action Verify printer connections and operation Typical printer problems include Paper jams O...

Page 248: ...Siemens technical support provider for assistance Q QC Sample Deleted Before Validation A control sample that was not validated has been deleted Daily QC may not be consistent R Rack or Position Barcode Not Read Alarm The barcode reader cannot determine a valid rack ID or position number for the current tube position The number of consecutive occurrences of this condition has met the criterion spe...

Page 249: ...y reset RBC Fragments Stop The number of consecutive occurrences of this condition has met the criterion specified for a stop message The autosampler halts at the same time the stop message occurs The specified stop criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Stop Criteria is reset when the Start Stop button is selected RBC Gho...

Page 250: ...fied for a stop message The reagent is empty and the autosampler has halted The specified stop criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria Reagent Conditions Corrective Action The stop counter is automatically reset after reagents are replenished and the Reagent Installation window is updated Go to Logs Reagent Log Reagent Installation Select Start Stop to co...

Page 251: ...isplay Ready to Run and the green ready to aspirate light is still off follow these steps to exit the ADVIA 2120 2120i software turn off the analyzer and then restart i Select Shut Down ADVIA at the Log On Off window ii Select Off at the analyzer touchpad iii Select CTRL ALT DELETE and log back onto the system to restart the software iv Restart the analyzer by selecting On at the analyzer touchpad...

Page 252: ...TE and log back onto the system to restart the software iv Restart the analyzer by selecting On at the analyzer touchpad 2 RBC Sheath syringe incorrectly assembled Follow the steps in Replacing the Syringe Plungers 3 Faulty power supply fuse cable pump assembly Can Bus Scrambler Board or Dual Servo Pump Control Board Call Siemens Service for assistance Ready to Run The system is ready to accept th...

Page 253: ...ustomize Menu System Setup Alarm Stop Criteria The counter associated with the Alarm Criteria is automatically reset RETIC Fit Suspect Stop The number of consecutive occurrences of this condition has met the criterion specified for a stop message The autosampler halts at the same time the stop message occurs The specified stop criterion is user definable in the Customize Menu System Setup Alarm St...

Page 254: ...onsecutive occurrences of this condition has met the criterion specified for an alarm message The specified alarm criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Alarm Criteria is automatically reset RETIC PLT Interference Error Stop The number of consecutive occurrences of this condition has met the criterion specified for a stop ...

Page 255: ...ampler halts at the same time the stop message occurs The specified stop criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Stop Criteria is reset when the Start Stop button is selected RETIC Slope Error Alarm The number of consecutive occurrences of this condition has met the criterion specified for an alarm message The specified ala...

Page 256: ...cting On at the analyzer touchpad S Sample ID Not Read Alarm Sample tube barcode label is unreadable or missing The number of consecutive occurrences of this condition has met the criterion specified for an alarm message Possible Cause 1 Barcode label improperly placed obscured or not present Corrective Action Verify that a barcode is present and correctly applied to the sample tube with the label...

Page 257: ...unication Failure The Align Optics or Direct Optics cycle was exited before result processing was complete Corrective Action Results produced when this error was triggered are invalid Repeat sample aspiration for the affected samples Sample SID Not Found Printing Aborted The sample displayed in the Review and Edit window does not exist in the database The system cannot provide the requested printo...

Page 258: ...rcode reader See 1a b c SD Not Defined For Test xx Control xxyyzzz No standard deviation is defined for this test and for this control in the Control Dictionary Corrective Action Define the SD in the Control Dictionary Selected Printer Not Available Result Report for SID The printer is not responding to a print request Corrective Action Check that the printer is powered on and has paper Refer to t...

Page 259: ...meout The selector valve failed to return to the home position within the expected time interval Possible Cause 1 Hardware failure Corrective Action a Reset the analyzer by selecting Utilities Exerciser Indicators Analyzer Reset b After about 1 minute if the status line does not display Ready to Run and the green ready to aspirate light is still off follow these steps to exit the ADVIA 2120 2120i ...

Page 260: ...ion date as determined by encoded reagent container barcode label or as calculated from installation date and open container stability Corrective Action Replenish expired reagents and update the Reagent Installation window Go to Logs Reagent Log Reagent Installation Sid Already Exists Result Message Rejected You have created a workorder with an Sid having the format 999XXXX This format is used by ...

Page 261: ...rmExc par The parameter file AlarmExc par is not correctly defined or there is a blank line in the file No exclusive analytical alarm will be taken into account in the patient QC calculation Corrective Action Call Siemens Service for assistance System Preparation Failed An error occurred during the initial system preparation phase Possible Cause 1 Software communication failure Corrective Action F...

Page 262: ...n ready to aspirate light is still off follow these steps to exit the ADVIA 2120 2120i software turn off the analyzer and then restart i Select Shut Down ADVIA at the Log On Off window ii Select Off at the analyzer touchpad iii Select CTRL ALT DELETE and log back onto the system to restart the software iv Restart the analyzer by selecting On at the analyzer touchpad T Test Not Buffered cTestCode T...

Page 263: ...t Dictionary Corrective Action As appropriate delete the test from the Type Table or reenter the test in the Test Dictionary U UFC Vacuum Out of Range UFC Vacuum is out of range The difference between the compressor vacuum and UFC vacuum is greater than 5 Hg Possible Cause 1 Vacuum Setting is out of range Corrective Action Check the system vacuum gauge and adjust the regulator if necessary Setpoin...

Page 264: ...ot is closed and the cap is on securely 3 Vacuum pump filter vacushield is clogged Replace the vacuum pump filter 4 Crimped waste line Check for a crimped waste line on the waste container Straighten or reconnect lines as necessary IMPORTANT If problems persist Call Siemens Service for assistance Further corrective action must be taken by Siemens service personnel only Unable to Process Results Ch...

Page 265: ... gauge and adjust the regulator if necessary Setpoint 20 Hg 1 2 Vacuum leak a Check for crimped or disconnected hydraulic or pneumatic lines Straighten or reconnect lines as necessary b Check the waste container to make sure that the spigot is closed and the cap is on securely Vacuum Out of Range Stop System vacuum is out of range Possible Cause 1 Vacuum gauge is out of range Corrective Action Che...

Page 266: ...to restart the software iv Restart the analyzer by pressing On at the analyzer touchpad 2 Faulty power supply fuse cable Valve Driver 1 Board or Can Bus Scrambler Board Call Siemens Service for assistance Valve Node 2 Error Reset Required Potential software communication error or a hardware failure associated with the Valve Driver 2 Board Possible Cause 1 Hardware failure Corrective Action a Reset...

Page 267: ... sensor cable is disconnected Verify connection is secure 3 Faulty level sensor Call Siemens Service for assistance WBC Substitution Alarm The number of consecutive occurrences of this condition has met the criterion specified for an alarm message The specified alarm criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Alarm Criteria is...

Page 268: ...e Action Check the Test Dictionary and the pending sample for the proper sample type Wrong Test Group Defined A test has been defined in several test groups or it has been defined in a test group but not in the Test Order Table The Data Manager cannot manage the defined test groups Corrective Action Use the Customer Parameters window to correct the test group definition X Y Z ...

Page 269: ...7 100 Status Line messages ...

Page 270: ...SORPTION CYTOGRAM 16 CALCULATING PARAMETERS 17 HEMOGLOBIN METHOD 21 CHEMICAL REACTIONS 21 ADVIA 2120 2120I HGB 21 BIBLIOGRAPHY 22 MEASUREMENT 22 CALCULATING PARAMETERS 23 PEROXIDASE METHOD 25 CYTOCHEMICAL REACTIONS 25 ADVIA 2120 2120I PEROX 1 25 ADVIA 2120 2120I PEROX 2 26 ADVIA 2120 2120I PEROX 3 26 ADVIA 2120 2120I PEROX SHEATH 26 MEASUREMENT 26 PEROX RATE HISTOGRAM 27 PEROX X HISTOGRAM 27 PEROX...

Page 271: ...GRAM 48 INTEGRATED ANALYSIS 48 CALCULATING RBC PARAMETERS 49 CALCULATING PLATELET PARAMETERS 53 NRBC ANALYSIS 56 RETICULOCYTE METHOD 58 CYTOCHEMICAL REACTIONS 58 ADVIA 2120 2120I AUTORETIC 58 MEASUREMENT 58 RETICULOCYTE METHOD NOMENCLATURE 59 RETIC RATE HISTOGRAM 59 RETIC ABS FLATNESS HISTOGRAM 60 RETIC ABS HISTOGRAM 60 RETIC VOLUME HISTOGRAM 60 RETIC HC HISTOGRAM 61 RETIC CH HISTOGRAM 63 RETIC SC...

Page 272: ...atically monitored by the analyzer must be between 32 C and 34 C If you want to check the baso reaction chamber temperature At the Utilities menu select Analyzer Status If you need to adjust the baso reaction chamber temperature 1 At the Special Procedures menu select Adjust Lamp Temp 2 Select Baso Temperature ADVIA 2120 2120i BASO Reagent NOTE For more detailed information on the contents of ADVI...

Page 273: ...the nuclear shape and cell density ADVIA 2120 2120i SHEATH RINSE encases the sample stream as the two fluids pass through the flowcell The optical signals from the flowcell are converted to electrical pulses by photodiodes After processing the following information is available BASO Rate histogram displays the arrival rate of cells in the Baso channel BASO X histogram displays the high angle light...

Page 274: ... channel PMNx of the PMN population on the x axis 2 The valley channel that separates the MN PMN populations 3 The valley channel contains the fewest number of cells between two populations The relative depth of the valley as expressed by d D BASO d D The Lobularity Index LI value provides an indication of sample abnormality The Ll is the PMN peak channel number on the Baso X histogram divided by ...

Page 275: ... and Lymphocyte nuclei 4 Basophils 5 Baso Suspect 6 Saturation 7 Polymorphonuclear WBCs Neutrophil and Eosinophil nuclei Noise Area This area contains platelets RBC stroma and other cellular debris that are not included in the total white blood cell count WBCB Blast Cluster When present blasts appear in the blast cluster Mononuclear Cluster In normal samples the MN population contains lymphocyte a...

Page 276: ...opulation the following cell populations are identified using histogram analysis Basophils MN mononuclear cells PMN polymorphonuclear cells Blasts Noise and Baso Saturation area A Baso Noise threshold B Blast threshold C MN PMN valley threshold D Basophil threshold E Baso Saturation threshold 1 Noise nuclei 2 Blast cell 3 Mononuclear WBCs Monocyte and Lymphocyte nuclei 4 Basophils 5 not used 6 Sat...

Page 277: ...shold This threshold shown as a red line separates the Basophils from the nuclei of the other cell types The threshold is set at channel 21 on the y axis All cells above this threshold are counted as Basophils Baso Saturation Threshold This threshold shown as a red line is set at channel 45 on the x axis and channel 21 on the y axis Events within this area microbubbles clumped cells and unlysed ce...

Page 278: ...hreshold The valley threshold shown as a red line separates the Mononuclear MN and Polymorphonuclear PMN populations The valley threshold is a floating threshold that is set using the Baso X histogram Abnormal Cell Locations If abnormal cells are present their size and nuclear configuration determine the location of their signals on the BASO cytogram Click the cytogram buttons below to see where t...

Page 279: ... the MN area on the BASO cytogram Location of NRBCs on the BASO Cytogram Nucleated Red Blood Cells NRBCs appear within the PMN population on the BASO cytogram However NRBCs are identified for flagging purposes in the peroxidase method The system uses data from the perox channel and the baso channel to derive the Nucleated Red Blood Cell NRBC count NRBC and NRBC If NRBCs are present the system corr...

Page 280: ...uses data from the perox channel and the baso channel to derive the Nucleated Red Blood Cell NRBC count NRBC and NRBC If NRBCs are present the system corrects the WBC results to account for them Additional Parameters The following parameters are for research or laboratory use only and are not for patient reporting Parameter Explanation BASO Suspect 100 x BASO Suspect BASO PHA Cells BLAST 100 x Bla...

Page 281: ...bsolute count of Basophils BASO Percent of Basophils BASO Suspect Percent of events from Baso Suspect area MN Percent of events from Mononuclear area PMN Percent of events from Polymorphonuclear area PMN Ratio Ratio of the percent of the Polymorphonuclear events to the percent of NEUTS and EOS obtainedfrom the peroxidase method BASO Dead Time Percent of analysis time when the channel is busy and c...

Page 282: ...ot The total number of events in the BASO Cytogram including the Noise area BASO Valid Cells B vc The number of valid electronic pulse signals detected from flowcell events BASO Saturation The number of events in the Saturation area 1 of the BASO cytogram BASO Count The number of cells in the Baso area 1 of the BASO cytogram ...

Page 283: ...4 Methods Blasts The number of events in the Blasts area 1 of the BASO cytogram PMN The number of events in the PMN area 1 of the BASO cytogram MN The number of events in the MN area 1 of the BASO cytogram ...

Page 284: ...Factor BASO WBC AS x 0 0012475 BasoCalFactor BASO WBC MCTS x 0 0012475 BasoCalFactor BASO WBC OTS x 0 0012475 To view the BASO WBC calibration factors click Cal Gain Logs on the System Logs menu FracDT The fraction of time that the channel is busy processing flowcell events While the baso channel is busy identifying a particular flowcell event it is unable to process any additional events that mig...

Page 285: ...counts for neutrophils lymphocytes monocytes polymorphonuclear PMN and mononuclear MN cells A research use only eosinophil count is also given CSF Scatter Scatter Cytogram The CSF Scatter Scatter Cytogram is a 100 x 100 channel two dimensional pulse height distribution of the scatter high and scatter low data for WBC RBC and noise where the X axis is high angle scatter and the Y axis is low angle ...

Page 286: ...PHA MN CSF PHA Total x CSF PHA Cells 1 Fractional Dead Time x Perox Nominal Factor CSF Neut CSF Neut 100 x CSF Neut CSF WBC CSF Neut CSF Neut μL CSF PHA Neut CSF PHA Total x CSF PHA Cells 1 Fractional Dead Time x Perox Nominal Factor CSF Lymph CSF Lymph 100 x CSF Lymph CSF WBC CSF Lymph CSF Lymph μL CSF PHA Lymph CSF PHA Total x CSF PHA Cells 1 Fractional Dead Time x Perox Nominal Factor CSF Mono ...

Page 287: ... cytogram CSF PHA Eos The number of cells falling in the Eosinophil Region of the CSF Scatter Absorption cytogram CSF PHA Lymphs The number of cells falling in the Lymphocyte Region of the CSF Scatter Scatter cytogram CSF PHA Monos CSF PHA Monos is the number of cells falling in the Monocyte Region of the CSF Scatter Scatter cytogram CSF PHA Neuts The number of neutrophils falling in the Neutrophi...

Page 288: ...l count CSF Neut The reportable CSF differential percentage neutrophil cell count CSF Lymph The reportable CSF absolute lymphocyte cell count CSF Lymph The reportable CSF differential percentage lymphocyte cell count CSF Mono The reportable CSF absolute monocyte cell count CSF Mono The reportable CSF differential percentage monocyte cell count CSF RBC The reportable CSF red blood cell count RBC μL...

Page 289: ...count CSF Lymph The reportable CSF differential percentage lymphocyte cell count CSF Mono The reportable CSF absolute monocyte cell count CSF Mono The reportable CSF differential percentage monocyte cell count CSF RBC The reportable CSF red blood cell count RBC μL CSF Eos The research only CSF differential percentage eosinophil cell count CSF Eos The research only CSF absolute eosinophil cell coun...

Page 290: ...ith cyanide in the ADVIA 2120 2120i HGB reagent to form the reaction product ADVIA 2120 2120i HGB NOTE For more detailed information on the contents of ADVIA 2120 2120i HGB reagent please see Chapter 8 ADVIA 2120 2120i HGB reagent contains a surfactant and potassium cyanide which are dissolved in an alkaline borate solution at pH 11 3 The surfactant hemolyzes the red blood cells and then emulsifie...

Page 291: ...ide Anal Chim Acta 262 67 1992 Measurement Optical readings are obtained colorimetrically at 565 or 546 nm according to the method installed After processing the optical data are plotted on the hemoglobin rate curve where time in seconds is plotted along the x axis and the percent light transmission is plotted along the y axis The hemoglobin transmission histogram is divided into five parts HGB Tr...

Page 292: ...ean Baseline Mean x Hgb Cal Factor x 50 0 MCH HGB RBC x 10 MCHC HGB RBC x MCV x 1000 Additional Parameters The following parameters are for research or laboratory use only and are not for patient reporting Parameter Explanation Calculated HGB CHCM x RBC x MCV 1000 Delta HGB HGB Calculated HGB HGB Baseline Transmission Baseline Mean x 3 05194E 4 HGB Sample Transmission Sample Mean x 3 05194E 4 HGB ...

Page 293: ...a Comparison Error MCHC CHCM CHCMCE sample system flag alerts operators to a condition that could be affecting one or more of the three results RBC MCV or HGB used to calculate MCHC For example severe lipemia is a known interference that can falsely elevate a HGB result obtained from the colorimetric hemoglobin method When the hemoglobin is falsely increased the MCHC is also falsely increased Usin...

Page 294: ... cells The perox reaction chamber temperature which is automatically monitored by the analyzer must be between 58 C and 72 1 C If you want to check the perox reaction chamber temperature use the Analyzer Status tab If you need to adjust the perox reaction chamber temperature 1 At the Special Procedures menu select Adjust Lamp Temp 2 Select Perox Temperature ADVIA 2120 2120i PEROX 1 NOTE For more d...

Page 295: ...hloro 1 naphthol in ADVIA 2120 2120i PEROX 2 serves as a substrate that enables the hydrogen peroxide in ADVIA 2120 2120i PEROX 3 to form a dark precipitate at endogenous sites of peroxidase activity in the granules of white blood cells as described by the following equation ADVIA 2120 2120i PEROX SHEATH NOTE For more detailed information on the contents of ADVIA 2120 2120i PEROX SHEATH reagent pl...

Page 296: ...the light scattering values for the noise lymphocyte and large unstained cells LUC areas Information from the monocyte neutrophil and eosinophil areas is excluded PEROX Cytogram is formed from the paired light scatter and absorption data Cluster analysis identifies the individual populations Perox Rate Histogram The PEROX Rate histogram shows the uniformity of the cell counting rate The rate histo...

Page 297: ... 2 The valley channel Noise Lymph Valley that separates the noise and lymphocyte populations 3 The relative depth of the valley as expressed by d D PEROX d D A Noise B Lymphocytes PEROX Cytogram The PEROX cytogram is divided into 100 counting channels on each axis The cells absorb light proportional to the amount of peroxidase stain present and this is represented on the x axis Cells scatter light...

Page 298: ...s Clumps If present platelet clumps appear in this area The platelet clump count is not included in the WBCP and differential but it is monitored for flagging purposes Lymphocyte and Basophil Cluster Lymphocytes and Basophils appear in the same cluster because they have similar size and no peroxidase activity LUC Cluster The LUC cluster contains Large Unstained Cells atypical lymphocytes blasts an...

Page 299: ...as The system uses data from the perox channel and the baso channel to derive the Nucleated Red Blood Cell NRBC count NRBC and NRBC If nRBCs are present the system corrects the WBC results to account for them Location of Atypical Lymphocytes on PEROX Cytogram Atypical lymphocytes are large cells with no peroxidase activity that can appear in the LUC area 1 Location of Blasts on PEROX Cytogram Simi...

Page 300: ...ear in the neutrophil area 1 and the saturation area 2 Location of Bands on PEROX Cytogram Bands appear within the the Neutrophil population 1 due to their similar size and degree of peroxidase staining Location of Platelet Clumps on PEROX Cytogram Platelet Clumps form a separate cluster 1 that originates in the Noise area on the PEROX cytogram ...

Page 301: ... Count PHA Cells MONO MONO 100 x WBC EOS 100 x Eosinophil Count PHA Cells EOS EOS 100 x WBC LUC 100 x LUC Count PHA Cells LUC LUC 100 x WBC The system uses data from the perox channel and the baso channel to derive the Nucleated Red Blood Cell NRBC count NRBC and NRBC If nRBCs are present the system corrects the WBC results to account for them The system can also display Peroxidase channel and Bas...

Page 302: ... Expected staining index Expected staining index 100 NEUT X Mean X channel for neutrophil cluster NEUT Y Mean Y channel for neutrophil cluster Noise Lymph Valley Valley channel between Noise and Lymph clusters Perox d D Lymph Mode Count Noise Lymph Valley Count Lymph Mode Count PEROX Dead Time 100 x FracDT PEROX Noise 100 x Noise PHA Cells PEROX Saturation 100 x Perox Saturation PHA Cells PEROX Fl...

Page 303: ...PH The percent of lymphocytes LYMPH The absolute count of lymphocytes Lymphocyte Count The number of events in the Lymphocyte area 1 of the PEROX cytogram MONO The percent of monocytes MONO The absolute count of monocytes Monocyte Count The number of events in the Monocyte area 1 of the PEROX cytogram ...

Page 304: ...count of large unstained cells Large Unstained Cell Count The number of events in the LUC area 1 of the PEROX cytogram RawWBC Perox Valid Cells x PHA Cells PHA Total PeroxCalFactor The sampler specific calibration factor PeroxCalFactor PEROX WBC AS x 0 001248 PeroxCalFactor PEROX WBC MCTS x 0 001248 PeroxCalFactor PEROX WBC OTS x 0 001248 To view the PEROX WBC calibration factors select Cal Gain L...

Page 305: ... number of events in the PEROX cytogram excluding the Noise area NOTE nRBC and PLT Clump events are components of Perox Noise Therefore they are not included in the PEROX PHA Cells PEROX PHA Total P tot The total number of events in the PEROX cytogram including the Noise area Perox Valid Cells P vc The number of valid electronic pulse signals detected from flowcell events HPX The number of events ...

Page 306: ...telets are isovolumetrically sphered using the ADVIA 2120 2120i RBC PLT reagent Step 2 RBCs and platelets are fixed ADVIA 2120 2120i RBC PLT NOTE For more detailed information on the contents of ADVIA 2120 2120i RBC PLT reagent please see Chapter 8 ADVIA 2120 2120i RBC PLT reagent contains sodium dodecyl sulfate SDS and glutaraldehyde which causes sphering of the red blood cells and platelets When...

Page 307: ...e light scatter measurement is converted into cell volume and the high angle light scatter measurement is converted into hemoglobin concentration The following histograms and cytograms are used for red blood cell analysis RBC Rate histogram shows the arrival rate of cells in the RBC Platelet channel RBC Volume histogram shows the distribution of red cells by cell volume RBC HC histogram shows the ...

Page 308: ...histogram shows the distribution of platelets by cell volume Platelet PM histogram shows the distribution of platelets by dry mass Platelet PC histogram shows the distribution of platelets by refractive index PLT Scatter cytogram is formed by plotting the high angle 5 to 15 high gain light scatter signals along the x axis and the low angle 2 to 3 high gain light scatter signals on the y axis PLT V...

Page 309: ...by cell volume The histogram has a range of 0 fL to 200 fL RBC Volume histogram normal sample 1 Microcytic region 2 Normocytic region 3 Macrocytic region 4 60 fL marker 5 120 fL marker Normal samples have a bell curve shaped distribution with a mode channel between 60 fL and 120 fL The mean corpuscular volume MCV and the red cell distribution width RDW are determined from this histogram The MCV is...

Page 310: ...tic region 3 Macrocytic region 4 60 fL marker 5 2120 2120i fL marker In samples with increased numbers of macrocytic red blood cells the histogram curve shifts to the right indicating an increase in the percentage of the cells with volumes greater than 2120 2120i fL RBC Volume histogram anisocytosis 1 Microcytic region 2 Normocytic region 3 Macrocytic region 4 60 fL marker 5 120 fL marker RDW is m...

Page 311: ... the hemoglobin distribution width HDW are obtained from this histogram The CHCM is the mean of the RBC HC histogram The HDW is the standard deviation of the RBC HC histogram The CHCM calibration factor has been applied to the displayed data RBC HC histogram hypochromic sample 1 Hypochromic region 2 Normochromic region 3 Hyperchromic region 4 28 g dL marker 5 41 g dL marker In samples with increas...

Page 312: ...alue can have different degrees of hypochromia and hyperchromia RBC CH Histogram The RBC CH cellular hemoglobin histogram represents the distribution of red blood cells by the amount of hemoglobin present in each cell independent of cell volume The histogram has a range of 0 picograms to 100 picograms Cellular Hemoglobin Content CH is the mean of the RBC CH histogram The cell hemoglobin distributi...

Page 313: ...rid encompasses RBC volumes between 30 fL and 180 fL and hemoglobin concentrations between 19 g dL and 49 g dL For a normal specimen the RBC population appears in the center of the map However since this map is nonlinear visually evaluating red cell morphology can be difficult Use the V HC cytogram which provides a linear presentation of cell volume and hemoglobin concentration RBC Volume Hemoglob...

Page 314: ...romic On the y axis RBC volume markers are set at 60 fL 1 and 2120 2120i fL 2 Red blood cells with a volume less than 60 fL are microcytic while cells with a volume greater than 2120 2120i fL are macrocytic RBC Matrix The RBC Matrix provides the cell counts and percentages for the nine regions of the RBC V HC cytogram NOTE Analysis of the RBC Volume and RBC HC histograms provides a quantitative an...

Page 315: ...et Y histogram is a 100 channel display of the low angle 2 to 3 high gain light scatter measurements that corresponds to the y axis on the PLT Scatter cytogram Platelet VOL Histogram The Platelet VOL histogram of the two dimensional PLT analysis shows the distribution of cells by volume Volume data are obtained from the integrated analysis The histogram has a range of 0 fL to 60 fL Large platelets...

Page 316: ...ram The PLT Scatter cytogram is the graphical representation of two light scatter measurements the high angle 5 to 15 high gain light scatter is plotted on the x axis A and the low angle 2 to 3 high gain light scatter is plotted on the y axis B 1 Platelets 2 Large platelets 3 Red blood cells 4 RBC fragments 5 RBC ghosts Using the Mie theory of light scattering for homogeneous spheres the low angle...

Page 317: ... concentration of the platelet component PC range 0 g dL to 40 g dL y axis B platelet volume range 0 fL to 60 fL Integrated Analysis The 2 Dimensional platelet analysis 2D PLT method is based on the integrated analysis of red blood cell and platelet measurements The PLT Scatter cytogram is formed by pairing light scatter signals acquired at low angle high gain and at high angle high gain that are ...

Page 318: ...L x axis A high angle 5 to 15 light scatter y axis B low angle 2 to 3 light scatter Area covered by the PLT Scatter Cytogram RBC fragments Large platelets RBCs RBC ghosts Calculating RBC Parameters Reported Parameters Parameter Explanation RBC Number of Red Cells x RBC Cal Factor x Dilution Factor x Coincidence correction Factor MCV Mean of RBC Volume histogram RDW 100 x SD of RBC Volume histogram...

Page 319: ...med RBC Coin Count Coincidence Count in RBC Scatter cytogram RBC R Count Number of RBCs in RBC Scatter cytogram RBC P Count Number of platelets in RBC Scatter cytogram RBC Valid Cells Number of Valid Signals Obtained from Flowcell Events MICRO Cell Count 30 fL to 60 fL in RBC Volume histogram MACRO 100 120 x Cell Count in RBC Volume histogram fL Total Cell Count in RBC Volume histogram MICRO 100 6...

Page 320: ... Distribution Width CHCM Corpuscular Hemoglobin Concentration Mean CH Cellular Hemoglobin Content HDW Hemoglobin Concentration Distribution Width HCT Hematocrit Number of red cells RBC R Count x RBC Valid Cells RBC R Count RBC P Count RBC R Count Number of cells in the RBC area 1 of the RBC Scatter Cytogram RBC Valid Cells The number of valid electronic pulse signals detected from flowcell events ...

Page 321: ...aw platelet count from the RBC method MACRO Percent of macrocytic red blood cells MICRO Percent of microcytic red blood cells MICRO Number of microcytic red blood cells HYPER Percent of hyperchromic red blood cells HYPO Percent of hypochromic red blood cells Micro Hypo Ratio This parameter is reported to be of use in differentiating two types of microcytic anemia Bibliography D Onofrio G Zini G Ri...

Page 322: ...of Platelet PM histogram PCDW SD of Platelet PC histogram P Count 2D Raw cell count for platelets and large platelets from 2D platelet analysis PCT PLT x MPV 10 000 PDW 100 x SD of Platelet VOL histogram MPV PLT N Mean of refractive index values for platelets only PLT X Mean of high angle high gain values for platelets only PLT Y Mean of low angle high gain values for platelets only PMDW SD of Pla...

Page 323: ... Platelet Volume histogram based on Integrated Analysis Large Platelet Count in the same units selected for PLT on the Unit Set Configuration window of the System Setup tab RBC Fragments This count includes events in the RBC Fragment area of the PLT Scatter cytogram that have volumes less than 30fL and refractive indexes greater than 1 400 1 RBC Ghost area 2 Platelet area 3 RBC Fragment area The R...

Page 324: ...cell events While the RBC Plt channel is busy identifying a particular flowcell event it is unable to process any additional events that might occur By measuring this dead time the analyzer can compensate for the missed events Note that the RBC Plt channel dead time has RBC and platelet components Corrected Platelet Count The corrected platelet count is calculated using the P Count 2D R Count 2D R...

Page 325: ... and Unstained line BASO Cytogram with location of nRBC The method identifies nRBCs by nuclear size in the Peroxidase channel and by nuclear density in the Basophil Lobularity channel In the unstained region of the Peroxidase Channel cytogram nRBC nuclei are located between the noise and lymphocytes They often form distinct populations which are analyzed to produce counts In the Basophil Lobularit...

Page 326: ...ne which if any of the NRBC counts to report NRBC Enumeration Histogram The NRBC Enumeration Histogram is a 100 channel display of the light scatter measurements and corresponds to the unstained region of the Peroxidase Channel Y axis histogram This display of the NRBC Analysis shows overlays of Unstained Events PLT Events NRBC Gauss Fit NRBC Residual Lymph Events The histogram also includes goalp...

Page 327: ...ass through the flowcell The low angle and high angle light scatter signatures are proportional to cell size and hemoglobin concentration Light absorption is proportional to RNA content The stained reticulocytes will absorb more light than the mature RBCs The two light scatter signals and the absorption signal are detected electronically amplified and split into six signals One of the low angle li...

Page 328: ...mean cell volume for the mature RBC reticulocyte and gated populations respectively Gated refers to the total population of RBCs containing both mature RBCs and reticulocytes Negative versus Positive Cell Populations Since reticulocytes have RNA and stain with ADVIA 2120 2120i autoRETIC reagent they are the positive cell population Mature RBCs do not stain and they are the negative cell population...

Page 329: ...ensates for drift in the absorption channel optics and for scattered light that is not collected RETIC Volume Histogram The RETIC Volume histogram represents the overlaid distributions of mature RBCs and reticulocytes by cell size only The histogram has a range from 0 fL to 200 fL The displayed data includes the MCVg calibration factor Mature RBC population red Reticulocyte population blue RETIC V...

Page 330: ...ariation CV of the RETIC Volume histogram channels 15 to 99 for the reticulocyte population RDWm Red cell Distribution Width is the coefficient of variation CV of the RETIC Volume histogram channels 15 to 99 for the mature RBC population RDWg Red cell Distribution Width is the coefficient of variation CV of the RETIC Volume histogram channels 15 to 99 for the gated cells RDW Delta RDWr RDWm RETIC ...

Page 331: ...ulation with cellular hemoglobin concentration less than 28 g dL CHCMr Cellular Hemoglobin Concentration Mean is the mean of the RETIC HC histogram for the reticulocyte population CHCMm Cellular Hemoglobin Concentration Mean is the mean of the RETIC HC histogram for the mature RBC population CHCMg Cellular Hemoglobin Concentration Mean is the mean of the RETIC HC histogram for the gated cells CHCM...

Page 332: ...LOW CHr Percentage of reticulocyte population with cellular hemoglobin less than 27 pg LOW CHm Percentage of mature RBC population with cellular hemoglobin less than 27 pg LOW CHg Percentage of gated cell population with cellular hemoglobin less than 27 pg CHr Cellular Hemoglobin Mean is the mean of the RETIC CH histogram for the reticulocyte population CHm Cellular Hemoglobin Mean is the mean of ...

Page 333: ...ld 4 Low Medium RTC threshold 5 Medium High RTC threshold A Mature RBCs B Low absorption retics C Medium absorption retics D High absorption retics E Platelets F Coincidence events The two thresholds on the y axis 1 2 are set as follows 1 The analyzer scans for the scatter mode between channels 10 and 99 on the y axis 2 The mean channel and standard deviation SD are calculated 3 The RTC Platelet t...

Page 334: ...d by three 2 The Low Medium RTC threshold 4 is set to the RTC threshold channel plus the value calculated in step 1 3 The Medium High RTC threshold 5 is set to the Low Medium RTC threshold channel plus the value calculated in step 1 RETIC V HC Cytogram On the V HC cytogram hemoglobin concentration is plotted along the x axis and cell volume is plotted along the y axis Cells identified as mature RB...

Page 335: ...t of red blood cell volume and hemoglobin concentration Applied Optics 24 9 1355 1365 1985 Calculating Retic Parameters Reported Parameters Parameter Explanation Retic RBC x Retic 100 x 1000 Retic 100 x RETIC Count RTC Gated Cells x RETIC Cal Factor CHr Mean of the RETIC CH histogram for the reticulocyte population System Parameters The following parameters are for research or laboratory use only ...

Page 336: ...use only and are not for patient reporting Parameter Explanation CHCMr Mean of the Retic HC histogram for the reticulocyte population MCVm Mean of the RETIC Volume histogram for the mature population MCVr Mean of the RETIC Volume histogram for the reticulocyte population Neg RBC Number of mature RBCs Neg RBC 100 x Neg RBC RTC Gated Cells Retic Count Number of reticulocyte events LRetic Number of l...

Page 337: ...s of the RETIC Scatter ABS cytogram Parameter Key RETIC Absolute number of reticulocytes RETIC Percent of reticulocytes CHCMr Reticulocyte Cellular Hemoglobin Concentration Mean CHr Reticulocyte Cellular Hemoglobin Content MCVm Mean Cell Volume of mature population MCVr Mean Cell Volume of reticulocyte population RBC The system always uses the RBC count from the RBC Platelet method even when a sam...

Page 338: ...ls with high scatter values greater than the RTC Coincidence threshold RTC Gated Cells The number of cells between the RTC platelet and RTC coincidence thresholds in the Retic Scatter Abs cytogram excluding channel 99 Neg RBC The number of cells in the mature RBC area 1 of the Retic Scatter Abs cytogram Neg RBC Count of mature red blood cells Neg RBC Percent of mature red blood cells ...

Page 339: ...orption Reticulocytes The number of gated cells 1 between the RTC and Low Medium RTC thresholds of the Retic Scatter Abs cytogram LRetic Count of low absorption reticulocytes LRetic Percent of low absorption reticulocytes Number of Medium Absorption Reticulocytes The number of gated cells 1 between the Low Medium RTC and Medium High RTC thresholds of the Retic Scatter Abs cytogram MRetic Count of ...

Page 340: ...ticulocytes Number of High Absorption Reticulocytes The number of gated cells 1 to the right of the Medium High RTC threshold of the Retic Scatter Abs cytogram HRetic Count of high absorption reticulocytes HRetic Percent of high absorption reticulocytes ...

Page 341: ...8 72 Methods ...

Page 342: ...TEM METHOD INFORMATION QUALITY CONTROL 15 SYSTEM METHOD INFORMATION GAIN ADJUSTMENT 15 SYSTEM METHOD INFORMATION CALIBRATION 16 SYSTEM METHOD INFORMATION RESULTS 16 SYSTEM METHOD INFORMATION LIMITATIONS OF THE PROCEDURE 16 SYSTEM METHOD INFORMATION EXPECTED VALUES 17 SYSTEM METHOD INFORMATION PERFORMANCE CHARACTERISTICS 17 CLSI DOCUMENT M29 A3 AND SIEMENS METHOD TOPICS CROSS REFERENCE 18 CBC METHO...

Page 343: ...LYTICAL RANGE 43 WBC DIFF METHOD 45 INTENDED USE 45 PRINCIPLES OF THE PROCEDURE 45 REAGENTS 47 STORAGE AND STABILITY 49 GAIN ADJUSTMENT 49 CALIBRATION 49 SAMPLE HANDLING 50 MATERIALS REQUIRED BUT NOT PROVIDED 50 PROCEDURE 51 QUALITY CONTROL 51 RESULTS 51 LIMITATIONS OF THE PROCEDURE 51 EXPECTED VALUES 52 PERFORMANCE CHARACTERISTICS IMPRECISION 52 PERFORMANCE CHARACTERISTICS CORRELATION DATA 53 RET...

Page 344: ... 3 PERFORMANCE CHARACTERISTICS CORRELATION DATA 61 PERFORMANCE CHARACTERISTICS CARRYOVER 61 PERFORMANCE CHARACTERISTICS ANALYTICAL RANGE 62 METHOD DATA SUMMARY 63 CBC METHOD DATA 63 WBC DIFF METHOD DATA 64 RETIC METHOD DATA 65 ...

Page 345: ...ct with human or animal body fluids should be handled before and after cleaning as if capable of transmitting infectious diseases Wear facial protection gloves and protective clothing The operator should follow the recommendations to prevent the transmission of infectious agents in health care settings as recommended for potentially infectious specimens in Protection of Laboratory Workers from Inf...

Page 346: ...sed in the manufacture of this product was tested by FDA approved methods and found nonreactive for hepatitis B surface antigen HBsAg antibody to hepatitis C HCV and antibody to HIV 1 2 all products manufactured using human source material should be handled as potentially infectious Because no test method can offer complete assurance that hepatitis B or C viruses HIV or other infectious agents are...

Page 347: ...822644 T03 3688 54 Hematology Control High 4 x 4 0 mL T03 3688 01 Hematology Control High 4 0 mL ADVIA 120 TESTpoint Hematology Control Low Product Number Symbol Contents Amount mL 00848547 T03 3686 54 Hematology Control Low 4 x 4 0 mL T03 3686 01 Hematology Control Low 4 0 mL ADVIA 120 TESTpoint Hematology Control Normal Product Number Symbol Contents Amount mL 05147873 T03 3687 54 Hematology Con...

Page 348: ...channel aperture impedance counter Macro dilutions of 1 500 for WBC and 1 50 000 for RBC are made using Class A glassware The reference Platelet Count Plt is performed using a hemocytometer and phase contrast microscopy The macro dilution for Plt is 1 125 using 1 ammonium oxalate as the diluent The reference hemoglobin method is performed using the NCCLS H 15A approved standard method with ICSH tr...

Page 349: ...u are stable until the last day of the month expiration date printed on the product label unless otherwise stated After being opened ADVIA OPTIpoint is stable for 7 days when stored closed in its original containerat 2 C to 8 C Ancillary Reagents The following ancillary reagents are necessary to operate the ADVIA 2120 2120i Hematology System All reagents must be free of particulates and other fore...

Page 350: ...ntel processors The number of significant digits is 14 The system rounds numbers for display to the specified number of digits in the appropriate unit set For example 4 674999999 becomes 4 67 4 675 becomes 4 68 This means that certain things might appear inconsistent such as the diff appearing to add up to 99 9 instead of 100 or the displayed value of derived results such as HCT not appearing to b...

Page 351: ...ld contact a local licensed biohazardous waste disposal firm for assistance The principal wastes associated with the use of the ADVIA 2120 2120i Hematology system are reagent containers sample containers system waste and customer replaceable system components All ADVIA 2120 2120i reagent containers are manufactured of recyclable high density polyethylene Sample containers with human specimens cont...

Page 352: ...0 01 0 01 Zinc 0 05 0 05 0 09 Cadmium 0 005 0 005 0 005 Copper 0 02 0 01 0 01 Lead 0 01 0 01 0 01 TOC g dL 0 2 2 1 1 6 Cyanide 2 38 0 33 0 05 Formaldehyde 0 896 720 adsorbable organic halide 0 59 1 97 2 32 purgeable organic halide mg dL of Cl 0 52 1 03 2 52 DMF 269 DMF was calculated by Siemens based on the dilution of the autoRETIC reagent in the system waste Volatile Organic Compounds in System ...

Page 353: ...etrachloroethane 1 1 1 Toluene 1 1 1 Freon 113 1 1 1 Tetrachloroethene 1 1 1 Chlorobenzene 15 5 3 Ethylbenzene 1 1 1 m p Xylenes 1 1 1 o Xylene 1 1 1 Hexachlorobutadiene 1 1 1 4 Chlorotoluene 1 1 1 2 Chlorotoluene 1 1 1 Isopropyl benzene 1 1 1 Bromoform 1 1 1 Styrene 1 1 1 1 3 5 Trichlorobenzene 1 1 1 1 2 3 Trichlorobenzene 1 1 1 1 2 4 Trichlorobenzene 1 1 1 1 2 Dichlorobenzene 16 4 2 1 3 Dichloro...

Page 354: ...tration in Title 21 Code of Federal Regulations A laboratory procedure manual is mandatory for good laboratory practice and regulatory compliance To aid in the preparation of a laboratory procedure manual refer to the cross reference that compares the organization of our method information with the guidelines for Clinical Laboratory Procedure Manuals formerly NCCLS in Protection of Laboratory Work...

Page 355: ...escriptions materials required but not provided and reagent preparation instructions The following briefly explains the significance of signal words used throughout these topics CAUTION Indicates a hazard that could cause illness burns skin reactions and so on This hazard is assigned to substances such as diluted acids mild caustics minor skin irritants or combustible materials ATTENTION Indicates...

Page 356: ... 2120i Hematology Systems be monitored using the ADVIA TESTpoint Hematology Controls Low Normal and High and ADVIA TESTpoint Reticulocyte Control Low and High Please refer to page 5 for product descriptions Control materials should be assayed at the beginning of each shift or at some other interval chosen by the laboratory after a reagent lot number change and after replacement of any part or comp...

Page 357: ...after checking gains Anytime control results and or moving averages are out of range and it has been verified that the out of control condition is instrument related System Method Information Results This topic describes expected flags or messages associated with analytical results System Method Information Limitations of the Procedure This topic describes substances conditions and patient states ...

Page 358: ... on the system Because this is a point estimate any single system tested with a similar protocol could yield a different estimate of imprecision and yet not be significantly different from the published average imprecision Correlation Data Correlation data were determined using human whole blood samples by comparing the performance of the ADVIA 120 Hematology System with the performance of a refer...

Page 359: ...conditions for patient preparation Sample Handling Limitations of the Procedure 5 1 4 2 Type of specimen Intended Use Sample Handling 5 1 4 3 Special handling conditions Sample Handling 5 1 5 Reagents 5 1 5 1 List reagents supplies and equipment Reagents 5 1 5 2 Directions for preparation Reagents 5 1 5 3 Parameters used to determine acceptable reagent performance Storage and Stability Quality Con...

Page 360: ...ndividual Laboratory Practice 5 1 7 7 If no controls are available list alternatives Quality Control if applicable 5 1 8 Procedure Stepwise 5 1 8 1 Detailed stepwise instructions Procedure 5 1 8 2 Centrifugation requirements Not applicable 5 1 8 3 Specify special glassware Not applicable Specify the following for photometric measurements Type of instrument Not applicable Wavelength Cuvette size So...

Page 361: ...ons for special precautions Sample Handling Limitations 5 1 11 2 List possible sources of error Sample Handling Limitations 5 1 11 3 Include helpful hints Procedure 5 1 11 4 Clinical situations that may influence test validity Sample Handling Limitations 5 1 11 5 Acceptable alternative procedures expected differences Performance Characteristics 5 1 11 6 Enlarge upon clinical applications According...

Page 362: ... of methods CBC Method Intended Use The ADVIA 2120 2120i Hematology System Complete Blood Count CBC method is intended to quantitatively measure the following hematological parameters White Blood Cell count WBC Red Blood Cell count RBC Hemoglobin concentration HGB Hematocrit HCT Mean Corpuscular Volume MCV Mean Corpuscular Hemoglobin MCH Mean Corpuscular Hemoglobin Concentration MCHC Corpuscular H...

Page 363: ...ade to each of the counts so that accurate counts are made over a wide range of each cell type Bibliography Kim YR and Ornstein L Isovolumetric sphering of erythrocytes for more accurate and precise cell volume measurement by flow cytometry Cytometry 3 b 419 427 1983 Zelmanovic et al US Patent pending RBC Platelet Size The method of sizing red cells and platelets uses the simultaneous measurement ...

Page 364: ...moglobin content of the erythrocyte J Lab Clin Med 17 899 911 1932 Bessman JD What s an RDW Am J Clin Pathol 76 242 1981 Mohandas N et al Accurate and independent measurement of volume and hemoglobin concentration of individual red cells by laser light scattering Blood 68 506 513 1986 Reagents The following ready to use reagents are required to perform the CBC method and maintain the ADVIA 2120 21...

Page 365: ...H RINSE 10 L 01554628 T01 3623 01 SHEATH RINSE 20 L ADVIA 120 DEFOAMER PN T01 3625 01 1 x 75 mL ADVIA 120 DEFOAMER contains Silicone emulsion 100 Shake before use For in vitro diagnostic use ADVIA 120 RBC PLT PN T01 3627 01 2 x 2700 mL ADVIA 120 RBC PLT contains Sodium dodecyl sulfate 0 035 mmol L Disodium EDTA dihydrate 4 03 mmol L Tetrasodium EDTA dihydrate 3 36 mmol L Sodium chloride 109 3 mmol...

Page 366: ...ell seek medical advice immediately show the label where possible Do not empty into drains For in vitro diagnostic use ADVIA 120 BASO PN T01 3629 01 2 x 1100 mL ADVIA 120 BASO contains Hydrochloric acid 9 00 mmol L Phthalic acid 21 49 mmol L Preservative Surfactant For in vitro diagnostic use ADVIA 120 CN FREE HGB PN T01 4288 01 2 x 1100 mL ADVIA 120 CN FREE HGB contains Dimethyl laurylamine oxide...

Page 367: ...product label unless stated otherwise After being opened ADVIA OPTIpoint is stable for 7 days ADVIA TESTpoint Hematology Controls are stable for 10 days and the ADVIA SETpoint Calibrator is stable for 5 days when stored closed in their original containers at 2 C to 8 C Gain Adjustment The gain adjustment procedure is used to adjust the amplification signals in a channel to properly position the ce...

Page 368: ...System Two whole blood specimens drawn from 15 normal apparently healthy donors were assayed shortly after phlebotomy and then again at intervals of 8 24 36 48 56 and 72 hours One of the whole blood specimens from each pair was stored at room temperature while the corresponding specimen was stored at 2 C to 8 C in capped blood collection tubes that contained EDTA as the anticoagulant The results i...

Page 369: ... laboratory s own quality control program and procedures Control materials should be assayed At the beginning of each shift or at some other interval chosen by the laboratory After a reagent lot number change After replacement of any part or component of the analytical module that may affect analytical performance As an option laboratories may run a retained patient sample periodically to monitor ...

Page 370: ...moglobin concentration values obtained from the RBC method the CHCM values are unaffected If the MCHC and CHCM differ by more than 1 9 g dL a Comparison Error system flag alerts the operator to this condition 6 Patient specimens with nucleated RBCs particularly neonate specimens may falsely elevate the WBC count When manually correcting the WBC count for the presence of NRBCs use the WBCB count 7 ...

Page 371: ...odes was tested by sampling from opened tubes and with the manual and automated closed tube samplers Parameter Mean Standard Deviation CV WBC 10 µL 5 91 0 16 2 7 RBC 106 µL 4 82 0 05 1 0 HGB g dL 13 3 0 11 0 8 MCV fL 81 0 0 3 0 4 CH pg 26 5 0 05 0 2 CHCM g dL 30 6 0 14 0 5 RDW 12 3 0 07 0 6 HDW g dL 2 56 0 02 0 8 PLT 10 µL 256 6 9 2 7 MPV fL 8 1 0 11 1 4 Performance Characteristics Correlation Dat...

Page 372: ...nicon H 3 RTC 0 98x 0 06 0 959 0 13 PLT 10 µL Technicon H 3 RTC 1 08x 2 0 0 991 27 MPV fL Technicon H 3 RTC 0 76x 0 9 0 925 0 4 x Technicon H 3 RTC system y ADVIA 120 Hematology system Performance Characteristics Carryover Sample carryover for the ADVIA 120 Hematology System was measured for WBC RBC HGB and PLT The performance specification for carryover is 1 for all parameters Carryover was evalu...

Page 373: ...of samples specially prepared to have high analyte values Multiple assays of the specially prepared pools were performed on the system Parameter Range Evaluated Maximum Observed Deviation WBC 10 µL 0 02 to 21 83 20 48 to 409 55 0 46 x 10 µL 4 1 RBC 106 µL 0 0 to 2 65 2 65 to 6 76 0 03 x 106 µL 1 1 HGB g dL 0 0 to 8 6 8 6 to 22 5 0 2 g dL 2 5 PLT 10 µL 5 to 208 205 to 3983 10 x 10 µL 4 9 ...

Page 374: ...l disorders the diagnosis of leukemias with CSF involvement and for monitoring patient therapy for leukemias and lymphomas An elevated WBC count with increased proportions of polymorphonuclear cells is usually an indication of bacterial meningitis In viral meningoencephalitis the cell counts may be lower with a predominance of mononuclear cells An unusually elevated RBC count can be an indication ...

Page 375: ... Fluids Third edition Chicago IL ASCP Press pp 65 157 1993 National Committee for Clinical Laboratory Standards Approved standard H20 A reference leukocyte differential count proportional and evaluation of instrumental methods Villanova Pennsylvania National Committee for Clinical Laboratory Standards 1992 Rümke C L The statistically expected variability in differential leukocyte counting In Diffe...

Page 376: ... is cloudy discolored or contains visible matter Controls When stored between 2 C and 8 C When stored as directed unopened controls are stable through the expiration date printed on the product label DO NOT FREEZE Opened containers are stable for 10 days Gain Adjustment The gain adjustment procedure is used to adjust the amplification signals in a channel to properly position the cell signatures w...

Page 377: ...d be prepared with CSF reagent immediately after dilution and will require a longer incubation period than undiluted samples or samples diluted in PBS 1 Add 300 µL of thoroughly mixed CSF sample patient or control to 300 µL of CSF Reagent in a labeled glass or plastic test tube 2 Cap and mix the prepared sample by gently inverting it 5 10 times or vortexing for 5 seconds Care should be taken to av...

Page 378: ...irations of distilled water or saline NOTE The CSF Wash cycle rinses the sample pathways without performing a background count The CSF Refresh cycle refreshes the flow cell background count without rinsing the sample pathways The background counts are stored in the startup log 6 Select Primer as the Sample Type and select OK Aspirate a saline primer to verify that background counts in the sample p...

Page 379: ...ing at least one sample or any cycle the system asks if you are sure you want to exit Select OK to leave the Cerebrospinal Fluid CSF window Select Cancel to keep using the CSF features NOTE If any samples were processed or cycles run in the CSF mode the system will perform a hydraulic exit cycle If no samples or cycles were run in CSF mode the system simply exits CSF mode Tip If a system left in C...

Page 380: ...and 4 parts normal saline or PBS the absolute counts will be multiplied by 5 The differential percentages are not affected by dilution and will not be multiplied by the dilution factor when correcting on the Review Edit tab Results on the Run Screen are not corrected for the dilution factor The Laser Power Low PL system flag is enabled for CSF analysis High Low flagging is provided for all CSF par...

Page 381: ...yzed RBCs in samples that have been diluted with normal saline before preparation with CSF reagent require a longer incubation period to sphere the RBCs in the sample The preferred diluent for CSF samples is PBS Samples diluted with normal saline must be prepared with CSF reagent immediately after dilution and must be incubated for 10 minutes in order to allow complete RBC sphering Samples contain...

Page 382: ... samples were aspirated 2 10 times Results from the 16 samples were pooled giving a total sample size of n 65 Precision of CSF WBC Counts n 65 Parameter Mean SD CV WBC 44 6 5 0 11 2 Precision of CSF RBC Counts n 65 Parameter Mean SD CV RBC 12 9 4 1 31 7 Precision of CSF WBC Differential n 65 Parameter Mean SD CV Neut 12 5 3 2 25 5 Lymph 74 9 5 1 6 9 Mono 8 3 3 2 39 3 MN 83 2 3 6 4 3 PMN 16 8 3 6 2...

Page 383: ...ual Mean ADVIA 120 Mean Bias 0 989 1 18 19 481 551 628 77 Absolute CSF WBC Differential The accuracy of the CSF absolute WBC differential was evaluated by comparing manual counts from 50 CSF patient samples to counts from the ADVIA 120 Hematology System Accuracy statistics are found in the table below Parameter R Slope Intercept Syx Manual Mean ADVIA 120 Mean Bias MN 0 896 1 07 4 8 9 14 5 PMN 0 97...

Page 384: ...ryover was less than 1 where carryover is expressed as the average percentage of the high level sample that is lost to the trailing low level sample Performance Characteristics Analytical Range The analytical range for CSF WBC and RBC counts was established by making serial dilutions of samples prepared to have low analyte values The dilution studies show that the CSF WBC count is accurate to 5 ce...

Page 385: ...RBC Absolute Deviation Deviation 0 00 0 0 0 0 05 2 1 1 0 1 4 3 1 0 2 9 6 3 1 0 34 29 5 10 0 308 288 20 7 100 reference level 2880 2880 0 0 NOTE Although RBC linearity has been demonstrated up to 2880 RBC μL samples with greater than 1500 RBC μL should be diluted to ensure the accuracy of the white count ...

Page 386: ...h cytochemical stains The enzyme peroxidase is present and active in several leukocyte types In the presence of hydrogen peroxide and an appropriate electron acceptor chromogen peroxidase develops a darkly colored material which precipitates in the cells Normal neutrophils and eosinophils possess significant levels of peroxidase activity with enzyme activity corresponding to cell maturation The mo...

Page 387: ...te blood cell count US Patent 4 801 549 Ansley H and Ornstein L Enzyme histochemistry and differential white cells on the Technicon Hemalog D In Advances in Automated Analysis Technicon International Congress 1970 Volume 1 Therman Associates Miami FL p 437 1971 Saunders AM Hemalog D system recent development In Advances in Automated Analysis Technicon International Congress 1972 Volume 3 Mediad In...

Page 388: ...0 01 PEROX 1 2 x 650 mL T01 3631 01 PEROX 2 2 x 305 mL T01 3632 01 PEROX 3 2 x 585 mL T01 3633 01 PEROX SHEATH 2 x 2725 mL ADVIA 120 BASO Product Number Symbol Contents Amount mL T01 3629 01 BASO 2 x 1100 mL ADVIA 120 SHEATH RINSE Product Number Symbol Contents Amount L 02337140 T01 3664 01 SHEATH RINSE 10 L 01554628 T01 3623 01 SHEATH RINSE 20 L ADVIA 120 PEROX 1 Prod No T01 3630 01 2 x 650 mL AD...

Page 389: ...nwell seek medical advice immediately show label where possible Use only in well ventilated areas For in vitro diagnostic use ADVIA 120 PEROX 2 PN T01 3631 01 2 x 305 mL ADVIA 120 PEROX 2 contains 4 Chloro 1 naphthol 44 8 mmol L Diethylene glycol 99 2 For in vitro diagnostic use ADVIA 120 PEROX 3 PN T01 3632 01 2 x 585 mL ADVIA 120 PEROX 3 contains Stabilizer Hydrogen peroxide 0 3 For in vitro dia...

Page 390: ...ng opened ADVIA OPTIpoint is stable for 7 days ADVIA TESTpoint Hematology Controls are stable for 10 days and the ADVIA SETpoint Calibrator is stable for 5 days when stored closed in their original containers at 2 C to 8 C Gain Adjustment The gain adjustment procedure is used to adjust the amplification signals in a channel to properly position the cell signatures within a cytogram Calibration The...

Page 391: ...arently healthy donors were assayed shortly after phlebotomy and then again at intervals of 8 24 36 48 56 and 72 hours One of the whole blood specimens from each pair was stored at room temperature while the corresponding specimen was stored at 2 C to 8 C in capped blood collection tubes that contained EDTA as the anticoagulant The results indicate that WBC DIFF parameters are stable within 2 stan...

Page 392: ...ugh the use of complex flagging algorithms laboratory personnel are alerted to suspected abnormal conditions These conditions are indicated by the appropriate flag such as and or color highlighting Whenever flags occur the user should review the results and take appropriate action Limitations of the Procedure The limitations of the procedure are as listed 1 Certain abnormal specimens such as those...

Page 393: ... MONO 4 9 EOS 1 7 BASO 0 1 LUC 1 4 NOTE Because of numerical rounding the Diff results should total 100 0 2 except when BASO is 5 and the Baso Count Suspect B SUSP BC flag is triggered In cases where the total is greater than 100 0 2 the amount in excess of 100 is due to BASO Performance Characteristics Imprecision A total of 18 runs were performed using multiple samples The following estimates of...

Page 394: ...ted using a protocol similar to that recommended in the NCCLS document EP9 A Method Comparison and Bias Estimation Using Patient Samples Approved Guideline 1995 Parameter Comparative System or Method Regression Equation y r Sy x NEUT Technicon H 3 RTC 1 02x 0 6 0 997 1 6 LYMPH Technicon H 3 RTC 1 00x 0 8 0 997 1 7 MONO Technicon H 3 RTC 0 85x 0 3 0 943 0 8 EOS Technicon H 3 RTC 0 87x 0 2 0 979 0 4...

Page 395: ...Low angle laser light scatter high angle laser light scatter and absorption characteristics of all cells are counted and measured The absorption data are used to classify each cell as a reticulocyte or mature red blood cell based on its RNA content Reticulocyte Size The method of sizing reticulocytes uses the simultaneous measurement of laser light scattered at two 2 different angular intervals wh...

Page 396: ...neous recombinant human erythropoietin in normal subjects Development of decreased reticulocyte hemoglobin content and iron deficient erythropoiesis J Lab Clin Med 123 660 667 1994 Fishbane S et al Reticulocyte hemoglobin content in the evaluation of iron status in hemodialysis patients Kidney Intl 52 217 222 1997 Reagents The following ready to use reagents are required to perform the Reticulocyt...

Page 397: ...d between 15 C and 30 C All unopened reagents are stable until the expiration date printed on the product label Opened containers of the ADVIA 120 autoRETIC reagent are stable for 120 days Opened containers of ADVIA 120 SHEATH RINSE are stable for 45 days Opened containers of ADVIA 120 EZ KLEEN and DEFOAMER are stable for 90 days Calibrators and Controls ADVIA 120 RETIC Control High Product Number...

Page 398: ... properly position the cell signatures within a cytogram Calibration The system must be calibrated for all parameters except RETIC Properly setting the RETIC gain factor provides sufficient accuracy of the RETIC result for most laboratories In such cases do not change the factory set RETIC calibration factor of 1 00 However laboratories using a manual counting method other than those recommended b...

Page 399: ...hours One of the whole blood specimens from each pair was stored at room temperature while the corresponding specimen was stored at 2 C to 8 C in capped blood collection tubes that contained EDTA as the anticoagulant The results indicate that RETIC parameters are stable within 2 standard deviations within run precision of the initial recovery for the specified time interval The stability of calcul...

Page 400: ...y s own quality control program and procedures Control materials should be assayed At the beginning of each shift or at some other interval chosen by the laboratory After a reagent lot number change After replacement of any part or component of the analytical module that may affect analytical performance As an option laboratories may run a retained patient sample periodically to monitor performanc...

Page 401: ...y elevated counts are often seen in samples that contain sickled cells or nucleated RBCs 2 Samples from patients having the following cell types or conditions may interfere with the ADVIA 120 Reticulocyte method Malarial parasites Pappenheimer Bodies Howell Jolly Bodies Heinz Bodies Inclusions that give rise to basophilic stipling Macrothrombocytes giant platelets Megaloblastic anemia Other rare p...

Page 402: ...al donors and 70 hospital donors with each sample run in duplicate n 260 The following regression statistics were computed using a protocol similar to that recommended in the NCCLS document EP9 A Method Comparison and Bias Estimation Using Patient Samples Approved Guideline 1995 Parameter Comparative System or Method Regression Equation y r Sy x RETIC 109 L Technicon H 3 RTC 0 79x 7 8 0 903 13 6 R...

Page 403: ...9 62 Regulatory Information Performance Characteristics Analytical Range The analytical range for RETIC parameter is Parameter Range Evaluated Maximum Observed Deviation RETIC 0 2 24 9 2 6 ...

Page 404: ...µL 1 1 HGB g dL 72 h 72 h 10 to 16 13 3 0 11 0 8 1 01x 0 2 0 997 0 2 0 2 0 0 to 8 6 8 6 to 22 5 0 2 g dL 2 5 MCV fL 8 h 24 h 76 to 100 81 0 0 3 0 4 0 90x 9 6 0 994 1 1 CH pg 36 h 53 h 24 to 35 26 5 0 05 0 2 1 00x 1 2 0 990 0 6 CHCM g dL 8 h 24 h 29 to 34 30 6 0 14 0 5 1 17x 6 5 0 974 0 5 RDW 72 h 72 h 12 to 15 12 3 0 07 0 6 0 86x 1 3 0 980 0 6 HDW g dL 72 h 72 h 1 9 to 3 0 2 56 0 02 0 8 0 98x 0 06...

Page 405: ...precision Correlation Data Room Temp Refrigerated Values Mean SD CV y r Sy x NEUT 36 h 72 h 40 to 77 55 0 0 9 1 6 1 02x 0 6 0 997 1 6 LYMPH 36 h 72 h 16 to 44 31 3 0 9 2 9 1 00x 0 8 0 997 1 7 MONO 72 h 72 h 4 to 9 7 2 0 5 6 9 0 85x 0 3 0 943 0 8 EOS 8 h 72 h 1 to 7 3 4 0 3 8 8 0 87x 0 2 0 979 0 4 BASO 72 h 56 h 0 to 1 0 5 0 1 20 0 0 67x 0 0 0 772 0 2 LUC 72 h 72 h 1 to 4 2 5 0 4 16 0 0 92x 0 6 0 9...

Page 406: ...ed Imprecision Correlation Data Observed Analytical Range Room Temp Refrigerated Values Mean SD CV y r Sy x Carryover Range Deviation RETIC 24h 72 h 0 8 to 2 1 1 2 0 16 13 3 0 82x 0 2 0 925 0 4 0 2 to 24 9 2 6 RETIC 10 6 L 40 to 79 57 8 7 7 13 3 0 79x 7 8 0 903 13 6 CHr pg 24 h 72 h 24 to 36 28 9 0 2 0 7 0 96x 4 2 0 940 1 7 RTC RBC Count 1 0 not available or not applicable for this parameter ...

Page 407: ...THE DAILY SHUTDOWN MANUALLY 15 DISCONNECTING AN AUTOSLIDE 90 CONFIGURATION 15 AUTOSLIDE METHODS 20 MAY GRÜNWALD GIEMSA METHOD 20 MODIFIED WRIGHT METHOD 25 WRIGHT GIEMSA METHOD 32 PERIODIC MAINTENANCE 37 REMOVING GLASS PARTICLE WASTE 37 CLEANING THE STAIN OVERFLOW TRAY 39 PERFORMING WEEKLY SHUTDOWN AND STARTUP 40 CLEANING THE STAINER WELLS AND PLATE 40 CLEANING THE FAN FILTER 43 REPLACING THE SMEAR...

Page 408: ...nalysis and microscope examination The system makes and stains slides based upon criteria that you can customize in the system software You can also choose to have slide making occur on all slides or no slides and you have the option for slides to be prepared but not stained IMPORTANT The system produces slides for samples aspirated in the autosampler mode only 1 Slide dispenser 2 Broken slide tra...

Page 409: ...he access doors on ADVIA Autoslide Slide Maker Stainer are equipped with sensors that stop Autoslide operation when opened Wear personal protective equipment Use universal caution For complete biohazard statement refer to section on Autoslide Safety Information and Warnings When the front access door is opened during Autoslide operation the slide maker portion of the system stops slide transfer an...

Page 410: ...er are equipped with sensors that stop Autoslide operation when opened Wear personal protective equipment Use universal caution For complete biohazard statement refer to section on Autoslide Safety Information and Warnings When the stainer access door is opened during Autoslide operation all Autoslide actions stop Autoslide Rear Panel Key Rinse Buffer Water Water Sensor Stain Waste Sensor Methanol...

Page 411: ...ed Check that earth wall plug is correctly connected to the laboratory grounding system If there is no such system a ground stake should be used Use only main supply cable delivered with the instrument or cable with same characteristics Europ cord type HO5VV F USA cord type SVT AWG 18 3 Main supply voltage fluctuations not to exceed 10 of the nominal voltage Fluidic and sensor connections BIOHAZAR...

Page 412: ...ur local service provider or distributor for necessary information Use the lifting handles delivered with the instrument to lift or move the instrument Before shipping the instrument whatever the destination an external decontamination must be carried out Perform a general cleaning of the instrument before transporting disposing of or temporarily removing it from use The Autoslide must be stored a...

Page 413: ...ircuit boards Operator injury may occur from an electric shock Electronic components can shock and injure the user Do not temper with the instrument and do not remove any components covers doors panels etc unless otherwise instructed within this document WARNING Do not disable sensors Doing so may result in operator injuries Do not open the Autoslide doors or covers during instrument operation Thi...

Page 414: ...10 8 ADVIA Autoslide Slide Maker Stainer Highly Flammable Highly flammable Keep away from sources of ignition No smoking ...

Page 415: ...y of Operation 1 Slide dispenser 6 Printer 11 Rack transfer 2 Drop needle 7 Stainer assembly 12 Slide transfer grabber 3 Slide carrier 8 Reagent syringes 13 Manual inlet 4 Sampling syringes 9 Rack out queue 14 Rack loader 5 Smearer 10 Verticalizer ...

Page 416: ...ck producing the smear After smearing the system raises the smearing head and the smearing tape moves to ready a clean section for the next slide 3 The slide enters the printer which can print patient demographics or other information directly on the slide 4 After printing the slide moves into the verticalizer which transfers it to a staining well or directly to a rack as required 5 If staining is...

Page 417: ... the system is not set to perform the daily shutdown cycle automatically perform the daily shutdown procedure manually Autoslide Operation Loading Reagents If reagent levels are low or the expiration date of a reagent has passed load additional reagents using the following procedure 1 Detach the appropriate reagent container and replace it with a new one 2 At the Logs menu select Reagent Log and t...

Page 418: ...enser must contain slides and there must be racks in the rack loader WARNING Do not try to empty the slide dispenser Finger injuries and sensor damage can occur if you attempt to remove slides from the slide dispenser Microscope slides storage and handling When storing and handling microscope slides follow these precautions Microscope slides and cover glasses should be rotated when stored To preve...

Page 419: ...l Stain waste must be collected using the tube and container specified by local regulation Stain waste contains methanol Methanol is a solvent that may destroy an inappropriate connection and cause leaks that are dangerous for the user and damaging to the instrument Dispose of waste according to local regulatory requirements WARNING Make sure that the Autoslide module is not processing slides whil...

Page 420: ...d away from the system 1 Make sure the ADVIA 2120 2120i system is not processing samples and is idle 2 At the Operations menu select Autoslide Control 3 In the Autoslide Control tab select the Manual STAT Door option and then select Start 4 When the door opens insert the slide into the holder door with blood smear on the right with the frosted end up Make sure the slide is fully seated in the hold...

Page 421: ...ner will be lost when a Fast Stop occurs When a Fast Stop occurs you must perform a Stainer Evacuation before returning to normal system operation Running the Daily Shutdown Manually Your system can be set to run the shutdown procedure at a preset time However if the system is not set to do so or if you are shutting down at a different time perform the following steps 1 At the Operations menu sele...

Page 422: ...le and ground strap has enough slack when you move the support structure 1 Make sure all system activity is complete before you disconnect the 90 configuration NOTE Make sure that no slides are present in the Autoslide Stainer 2 Place the ADVIA 2120 2120i system in Standby 3 Select Off on the control panel to shut off the ADVIA 2120 2120i system This prevents any further system function The system...

Page 423: ...ADVIA Autoslide Slide Maker Stainer 10 17 5 Pry open the protective conduit tubing where the vacuum 1 and pressure 2 lines reside Figure 2 Vacuum and Pressure Lines ...

Page 424: ...utoslide Slide Maker Stainer 10 18 6 Push the metal lever and pull the vacuum line 1 to disconnect Figure 3 Vacuum Line 7 Push the metal lever and pull the pressure line 1 to disconnect Figure 4 Pressure Line ...

Page 425: ...nsuring that the electrical cables are not stretched to far 1 Blood sample line 2 Pressure line 3 Ground strap 4 Vacuum line Figure 6 Moved Support Structure NOTE The ground strap and interface cable remain connected to the Autoslide Disconnecting the sample blood line pressure line and vacuum lines allows you to move the Autoslide approximately 0 3 m 1 ft 10 To reconnect the Autoslide move the Au...

Page 426: ...de Maker Stainer Stained smears are evaluated to identify and quantify cells in whole blood and other specimens to aid clinicians in the assessment of various clinical conditions Summary and Explanation The reagent protocol for the ADVIA Autoslide Slide Maker Stainer consists of a modified methylene blue eosin stain and is based on the original stain proposed by Pappenheim The ADVIA Autoslide Slid...

Page 427: ... DN2 Buffer 8 1 DN3 Dil Stain 2 13 1 DN4 Methanol 31 0 DN7 Rinse 18 2 AN2 8 1 AN3 13 1 AN4 31 1 AN7 18 3 Methanol Volume mL 1 6 Stain Volume mL 3 6 Dilution Ratio 5 Duration Long Principle of the Procedure The 2 staining mixtures used by this protocol have very distinct proprieties The May Grünwald STAIN 1 stains acidophilic sites of cells and the neutrophilic granulations of leukocytes whereas th...

Page 428: ...uclei Purplish blue Cytoplasm Faint pink Granules Deep purple Platelets Cytoplasm Light blue Granules Blue to violet blue Red Blood Cells Biconcave disks Pink Howell Jolly bodies Dark purple Dohle bodies Blue gray Promyelocyte and Auer Rods Granules Dark blue to Purplish red Causes of RBC Artifacts Post stain rinsing too short Reagents expired May Grünwald Stain open for extended period Dirty stai...

Page 429: ... Methanol 99 65 Methylene blue Eosin 0 35 R39 23 24 25 S7 S24 S36 37 S45 Toxic Toxic danger of very serious irreversible effects through inhalation in contact with skin and if swallowed Keep container tightly closed Avoid contact with skin Wear suitable protective clothing and gloves In case of accident or if you feel unwell seek medical advice immediately show the label where possible Contains me...

Page 430: ...fects through inhalation in contact with skin and if swallowed Keep container tightly closed Avoid contact with skin Wear suitable protective clothing and gloves In case of accident or if you feel unwell seek medical advice immediately show the label where possible Contains methanol R11 S16 Highly Flammable Highly flammable Keep away from sources of ignition No smoking Contains methanol Reagent St...

Page 431: ...support provider or distributor Bibliography 1 White WL Erickson MM Stevens SC Practical Automation for the Clinical Laboratory St Louis MO CV Mosby Co pp 476 487 1972 2 Moss ED Automated Slide Staining in Haematology Can J Med Tech 30 5 169 1968 3 Langeron M Precis de microscopie Masson Paris 6eme ed pp 566 585 1942 Modified Wright Method Intended Use The Modified Wright method is for in vitro di...

Page 432: ...is a smart fully automated system It is capable of producing stained smears on all specimens run on the ADVIA 2120 2120i or only on samples with predefined criteria i e flags or parameter threshold The Autoslide provides also a direct access port to the stainer for pre smeared slides ...

Page 433: ...r Wright Giemsa Stain DN3 5 Draining AN7 6 Dispensing rinsing solution distilled water DN7 7 Draining AN7 8 Dispensing rinsing solution distilled water DN7 9 Draining AN4 10 Dispensing methanol DN4 11 Slide removal Needle Position Action DN1 Undil Stain 1 32 1 DN2 Buffer 22 0 DN3 Dil Stain 2 8 1 DN4 Methanol 31 0 DN7 Rinse 24 2 AN2 22 0 AN3 8 1 AN4 31 1 AN7 24 2 NOTE Needles AN2 and DN2 in positio...

Page 434: ...Nuclei Light purple with distinct spaces between chromatin strands Cytoplasm Dull blue gray with lightly stained Granules Fine pink to violet and evenly distributed Eosinophils Nuclei Pale purplish blue and well defined Cytoplasm Bluish pink Granules Reddish orange large and spherical in shape Basophils Nuclei Purplish blue can have reddish tone Cytoplasm Faint pink Granules Distinct deep purplish...

Page 435: ...00142 0097053 Japan Modified Wright Stain 4 x 3 8 L 1 gallon 08100290 Modified Wright Buffer 4 x 3 8 L 1 gallon 08096412 00096669 Japan Methanol 4 x 3 8 L 1 gallon 06837687 ADVIA Autoslide Rinse 10 L Modified Wright Stain Methanol 99 Polychrome methylene blue eosin stain 0 3 R39 23 24 25 S7 S24 S36 37 S45 Toxic Toxic danger of very serious irreversible effects through inhalation in contact with sk...

Page 436: ...ant Methanol Methyl Alcohol 99 8 R39 23 24 25 S7 S24 S36 37 S45 Toxic Toxic danger of very serious irreversible effects through inhalation in contact with skin and if swallowed Keep container tightly closed Avoid contact with skin Wear suitable protective clothing and gloves In case of accident or if you feel unwell seek medical advice immediately show the label where possible Contains methanol ...

Page 437: ...cimen collection Material required but not provided Microscope slides 26 x 76 x 1 mm Size 76 x 26 x 1mm Description ground edges rounded corners super frost Use slides provided by Siemens approved vendors only Limitations Modified Wright reagents produce high quality stained blood films However there may be personal preferences in shades and intensities of staining not satisfied by the system Resu...

Page 438: ... reagent protocol for the Autoslide Slide Maker Stainer consists of a modified polychrome methylene blue eosin stain and is based on the original stain proposed by Romanowsky The ADVIA Autoslide Slide Maker Stainer is a smart fully automated system It is capable of producing stained smears on all specimens run on the ADVIA 2120 2120i or only on samples with predefined criteria i e flags or paramet...

Page 439: ... Procedure The stained smear is examined microscopically the nucleus and the cytoplasm of neutrophils lymphocytes monocytes eosinophils and basophils show a characteristic blue or red coloration Cells are then manually differentiated and quantified Cell Type Cell Component Color Neutrophils Nuclei Vibrant deep purple Cytoplasm Pink background Granules Light purple violet Lymphocytes Nuclei Distinc...

Page 440: ...h pink in color intensity of stain is less in central area where cell is thinnest Howell Jolly bodies Dark purple Dohle bodies Cytoplasm Pale Blue to pale blue gray Promyelocyte Granules Dark blue to reddish blue Auer Rods Cytoplasm Purplish red Causes of RBC Artifacts Post stain rinsing too short Reagents expired Stain open for extended period Dirty stainer Room temperature too high Humidity too ...

Page 441: ...edical advice immediately show the label where possible Contains methanol R11 S16 Highly Flammable Highly flammable Keep away from sources of ignition No smoking Contains methanol Wright Giemsa Buffer Phosphate buffer Surfactant Preservative Methanol Methyl Alcohol 99 8 R39 23 24 25 S7 S24 S36 37 S45 Toxic Toxic danger of very serious irreversible effects through inhalation in contact with skin an...

Page 442: ...super frost Use slides provided by Siemens approved vendors only Limitations Wright Giemsa reagents produce high quality stained blood films However there may be personal preferences in shades and intensities of staining not satisfied by the system Results When used with the ADVIA Autoslide Slide Maker Stainer the Wright Giemsa reagents will produce a consistent stain quality to facilitate accurat...

Page 443: ...upply fan filter As Needed Replace the smearing tape and cleaning the smearing wedge Replace the printer ribbon Removing glass particle waste Small particles of glass may be chipped off the slides during transfer from the slide dispenser to the slide carrier These particles are collected in a tray beneath the slide dispenser To remove glass particle waste WARNING Use caution when handling or troub...

Page 444: ...10 38 ADVIA Autoslide Slide Maker Stainer 2 Discard the glass particles according to your standard laboratory procedures 3 Replace the tray securely under the slide dispenser ...

Page 445: ...ransmitted by Blood Body Fluids and Tissue 2d edition Approved Guideline 1997 Document M29 A National Committee for Clinical Laboratory Standards NCCLS This document contains complete information on user protection and it can be used as reference material for instructions on laboratory safety Small amounts of stain may overflow from the stainer wells This overflow is collected in a tray located on...

Page 446: ... before slide production can resume If you want turn the system off after the Weekly Shut Down wait until you are ready to run more samples before performing the Weekly Startup 4 At the Clean Autoslide window select Weekly Startup 5 Follow the instructions displayed on the window to perform a weekly startup Cleaning the Stainer Wells and Plate BIOHAZARD All products or objects that come in contact...

Page 447: ... protective clothing and gloves In case of accident or if you feel unwell seek medical advice immediately FLAMMABLE Methanol is flammable Keep away from sources of ignition no smoking CAUTION Make sure all slides are processed and transferred to the output queue before turning off the Autoslide Turning off the autoslide while slides are processing can cause unreliable results and possibly damage A...

Page 448: ... place on the stainer plate Place the stainer wells in a tray with enough methanol to completely cover them Agitate the tray to remove any air bubbles 4 While the wells are soaking use a soft cloth or paper towel to clean the stainer plate Rotate the plate manually to clean the entire surface 5 After the wells have soaked in the methanol for ten minutes remove them from the tray and dry them with ...

Page 449: ...e and Cleaning the Smearing Wedge BIOHAZARD All products or objects that come in contact with human or animal body fluids should be handled before and after cleaning as if capable of transmitting infectious diseases Wear facial protection gloves and protective clothing The operator should follow the recommendations to prevent the transmission of infectious agents in health care settings as recomme...

Page 450: ...Tape 4 Open the Autoslide lower front cover 5 Using the black magnetic knob open the tape holder plate 6 Remove the upper and lower bobbins from their holders 7 Each time the smearing tape is replaced wipe the wedge using a soft cloth to remove any dust 8 Place the new smearing tape bobbin on the upper holder and the take up bobbin on the lower holder Be careful not to twist or crimp the tape Thre...

Page 451: ...utes Analyzer mode Standby To replace the print ribbon CAUTION Make sure all slides are processed and transferred to the output queue before turning off the Autoslide Turning off the autoslide while slides are processing can cause unreliable results and possibly damage Autoslide components 1 Turn off the Autoslide 2 Open the lower front cover and remove the slide rack loader to gain easy access to...

Page 452: ...removing it 4 Install the new printer cartridge securely in its holder Make sure the notches on the cartridge are positioned correctly in the holder 5 Replace the slide rack loader close the lower front cover 6 Place the analyzer in Ready mode then turn the Autoslide on Wait a few seconds The Autoslide will perform a Mechanical Initialization You must wait for the initialization to execute automat...

Page 453: ... TIP 2 In addition to clearing the source of the problem such as removing a jammed rack etc check the Autoslide Status Screen when an error occurs If both the stainer and smearer are RED and there are no slides in the stainer a MECHANICAL INITIALIZATION homes both smearer and stainer must be performed If only the smearer is RED a RESET SMEARER restores the system to Ready GREEN and allow any slide...

Page 454: ...Siemens ASL Critical Error Stop Failure General autoslide critical error software error unrecognized version emergency stop communications bad parameter EEPROM error not initialized sync error sample may be diluted hardware error autoslide interface error command timeout command status Run stopped if Alarm Stop criteria set Check message log for other errors correct problem reset autoslide see Tip...

Page 455: ...er error Failure Printer ribbon not advancing or jammed Open front panel inspect printer ribbon clear jam or replace ribbon as needed Ensure that there are no glass particles in the printer area Run a Mechanical Initialization cycle Cycle autoslide power if necessary ASL Rack Error Stop Failure General rack problem could be low on racks Replenish racks in dispenser check for jammed rack or full ej...

Page 456: ... startup procedure to drain the methanol ASL Staining Error Stop Failure Stainer door was open Run stopped if Alarm Stop criteria set Close stainer door reset autoslide resume run ASL Staining waste is full ASL Staining Waste Full Stop Failure Staining Waste is full stainer enabled Dispose of staining waste according to local regulations Perform a Reset Autoslide if necessary ASL Unknown error Fai...

Page 457: ...annot be Opened Warning The manual inlet door cannot be opened because the stainer is not enabled for use or the ADVIA 2120 2120i Autosampler is active Enable the stainer in the Autoslide options menu or stop Autosampler if appropriate and try again Autoslide Manual Inlet Door Failed to Open Warning An error occurred while attempting to open the manual inlet door Check for something blocking the S...

Page 458: ...Up to 108 slides per hour Dimensions Weight 60 kg approx Width 91 cm Depth 70 cm Height 50 cm Operating Temperature Range 20 30 C Relative Humidity 30 60 Noise Level 65 decibels Electrical Requirements From 100V to 240V 10 Maximum 200 VA Slide Requirements super frost rounded corner ground edges 76 mm x 26 mm x 1 mm Use slides provided by Siemens approved vendors only Sample Requirement 75 μL whol...

Page 459: ...D 2 ADDITIONAL SERVICE PERIOD 2 SERVICE DURING NORMAL HOURS 2 EXTENT OF A SERVICE CALL 3 SERVICE OUTSIDE NORMAL HOURS 3 REPLACEMENT OF PARTS 3 DESIGN CHANGES AND RETROFITTING OF INSTRUMENTS 3 KEY OPERATOR DESIGNATION 3 OSHA REQUIREMENTS US ONLY 4 WARRANTY AND SERVICE EXCLUSIONS 4 CONTACT INFORMATION 5 ADDRESSES 5 ...

Page 460: ...itially agreed upon period When the customer calls for service the Siemens representative or authorized distributor informs the customer of the type of service available for the customer s instrument and instructs the customer as to how to obtain that service Warranty Period The limited warranty period generally commences upon installation of the original instrument at the customer s location and ...

Page 461: ...epair the instrument or arranges for the exchange of the instrument or affected parts at no charge with the exception of certain parts or subassemblies that are considered Customer Maintenance Items Customer Maintenance Items include but are not limited to the following items lamps electrodes or sensors which are covered by a separate warranty reagents calibrators controls paper and pens Consult t...

Page 462: ... of their instrument and customer has not agreed to retrofit or make design changes to the instrument 4 Customer did not purchase the instrument from Siemens or one of its authorized distributors 5 The instrument has not been installed within 90 days of shipment to the customer s facility unless otherwise specified 6 The customer has not performed appropriate customer maintenance procedures as out...

Page 463: ...F ANY WARRANTY OR SERVICE AGREEMENT SHALL BE LIMITED ONLY TO THE REPAIR OR REPLACEMENT OF DEFECTIVE EQUIPMENT AND SHALL NOT INCLUDE ANY DAMAGES OF ANY KIND WHETHER DIRECT INDIRECT INCIDENTAL CONTINGENT OR CONSEQUENTIAL SIEMENS SHALL NOT BE LIABLE FOR DELAY FROM ANY CAUSE IN PROVIDING REPAIR OR EXCHANGE SERVICE ANY LIMITATIONS OR OTHER PROVISIONS NOT CONSISTENT WITH APPLICABLE LAW IN PARTICULAR JUR...

Page 464: ...LATIONS 3 CE MARK REQUIREMENTS 3 NOISE LIMIT REQUIREMENT 4 DOCUMENTATION 4 SYSTEM SYMBOLS 4 INTERPRETATION OF RESULTS 9 EXPLANATION OF THE WARNING LABELS ON THE AC POWER BOX 10 EXPLANATION OF THE WARNING LABELS ON THE MANUAL CLOSED TUBE SAMPLER 11 PROTECTING YOURSELF FROM LASERS 12 RBC LASER OPTICAL ASSEMBLY 12 AUTOSAMPLER BARCODE READER 13 ...

Page 465: ...s never look directly at the laser beam or at its reflection from a shiny surface All field service procedures must be followed precisely Only Siemens trained field service personnel should perform procedures related to laser assemblies For more safety information and laser specifications refer to Safety Information Protecting yourself from lasers WARNING When handling EZ KLEEN wear protective clo...

Page 466: ...ces C Part 15 105 A This equipment has been tested and found to comply with the limits of a Class A digital device pursuant to part 15 of the FCC Rules These limits are designed to provide reasonable protection against harmful interference when equipment is operated in a commercial environment This equipment generates uses and can radiate radio frequency energy and if not installed and used in acc...

Page 467: ...dures and practices are not correctly followed Hazards associated with the presence handling or use of required reagents are categorized as follows CAUTION Indicates a hazard that could cause illness burns skin reactions and so on Substances such as diluted acids mild caustics minor skin irritants and combustible materials are assigned to this category ATTENTION Indicates that a specific risk exis...

Page 468: ... the instructions for use Biohazard The biohazard warning label mounted on the front of the analyzer alerts you to the possibility of exposure to a biohazard during the sampling process or through contamination of the analyzer This symbol identifies a product that may contain an infectious agent This symbol alerts you to a potentially harmful substance These symbols together alert you to a waste b...

Page 469: ...at the product complies with the applicable directives of the European Union This symbol indicates that the product was IEC 61010 1 safety tested by TUV for conformity to global markets including Canada US and EU This symbol indicates that the colorimeter conforms with DIN standard 58 960 developed by the Working Committee on Photometers of the Standards Committee on Medicine NAMed in the DIN Deut...

Page 470: ...This symbol indicates the need to empty the waste container This symbol indicates the open and closed positions for a spigot This symbol indicates liquid waste This symbol indicates pressure In this example the symbol indicates 20 PSI This symbol indicates vacuum In this example the symbol indicates a vacuum of 20 Hg This symbol indicates the manual open tube sampler This symbol indicates the manu...

Page 471: ...his is the CPU symbol This symbol indicates a protective terminal This is the barcode scanner symbol This symbol indicates that moving the component can cause injury This symbol identifies a product that contains recyclable material This symbol indicates the top of the package This symbol indicates the acceptable temperature range for storage of the product This symbol identifies the date by which...

Page 472: ...he DEFOAMER symbol This is the EZ KLEEN symbol This is the BASO Reagent symbol This is the CSF Reagent symbol This is the HGB Reagent symbol This is the CN FREE HGB Reagent symbol This is the PEROX 1 Reagent symbol This is the PEROX 2 Reagent symbol This is the PEROX 3 Reagent symbol This is the PEROX SHEATH symbol This is the RBC PLT Reagent symbol This is the SHEATH RINSE symbol Interpretation o...

Page 473: ...ddressed by laboratory personnel Various sections of the Product Labeling address malfunctions and their possible effect on results Explanation of the warning labels on the AC power box 1 The AC power box must be opened by qualified personnel only The only operator serviceable parts in the AC power box are fuses F1 through F7 which are replaced without opening the module 2 The two electrical outle...

Page 474: ...nual Closed Tube Sampler Never put your finger into the manual closed tube sampler centering collar To avoid injury when removing or replacing the manual closed tube sampler needle or centering collar the system must be off You must place a protective cover over the needle immediately after removing the centering collar ...

Page 475: ...BC laser optical assembly The RBC laser optical assembly is classified as a Class II laser device which has a maximum power output of 800 μW at 670 nm nominally and a continuous wave output The RBC laser assembly is set internally to have a maximum output of 290 58 μW The laser beam path is enclosed in a series of non interlocked protective housings that prevent human access to laser radiation dur...

Page 476: ...n All field service procedures must be followed precisely to prevent possible eye injury from the laser radiation Only Siemens trained field service personnel should perform procedures related to the ADVIA 2120 2120i laser optics bench Laser Hazard Precautions The following list of precautions must be observed when servicing the ADVIA 2120 2120i laser optics Remove all jewelry from hands and wrist...

Page 477: ...B 14 Warnings and Safety Information ...

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