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1 

 

 

Contents

 

 

P

REFACE

 .................................................................................................................................................. 3 

Introduction ................................................................................................................................... 3

 

 

S

ECTION 

1:

 

S

AFETY 

I

NSTRUCTIONS

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

Section Overview ........................................................................................................................... 5 
1.1 Intended Use ............................................................................................................................ 5 
1.2 Safety Instruction .................................................................................................................... 6 
1.3 Biohazards ................................................................................................................................ 6 
1.4 Emergency Procedure ............................................................................................................. 7 
1.5 Warning Signs in Manual ....................................................................................................... 7 
1.6 Signs on Equipment ................................................................................................................. 8

 

 

S

ECTION 

2:

 

I

NSTALLATION

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

Section Overview ......................................................................................................................... 10 
2.1 Unpacking / Operating Placement & Environment ........................................................... 10 
2.2  Installation Checklist and Menu ......................................................................................... 12 
2.3  Analyzer Cable, Interface, and Printer Connections ........................................................ 14 
2.4  Reagent Installation.............................................................................................................. 15 
2.5 Changing Reagents ................................................................................................................ 18 
2.6  Power Supply ........................................................................................................................ 18

 

 

S

ECTION 

3:

 

G

ENERAL 

O

VERVIEW

 ....................................................................................................... 20 

Section Overview ......................................................................................................................... 20 
3.1 General Instrument Overview .............................................................................................. 20 
3.2 Menu Structure ...................................................................................................................... 21 
3.3 System Flow ........................................................................................................................... 23 
3.4 Sample Volume, Throughput, and Parameters .................................................................. 24

 

 

S

ECTION 

4:

 

I

NSTRUMENT 

S

ETUP

 ......................................................................................................... 25 

Section Overview ......................................................................................................................... 25 
4.1 Menu Selection ....................................................................................................................... 25 
4.2 Initial Setup ............................................................................................................................ 26 
4.3 Advanced Setup ..................................................................................................................... 27 
4.4 Reagent Setup ........................................................................................................................ 31 
4.5 User Interface ........................................................................................................................ 33

 

 

S

ECTION 

5:

 

S

AMPLE 

A

NALYSIS

 ............................................................................................................ 36 

Section Overview ......................................................................................................................... 36 
5.1 Preparations before Analysis ................................................................................................ 36 
5.2 Startup Sequence ................................................................................................................... 37 
5.3 Background Count ................................................................................................................ 39 
5.4 Sample Identification ............................................................................................................ 39 
5.5 Analyzing the Sample (Open Tube) ..................................................................................... 40 
5.6 Analyzing the Sample (Pre-dilution procedure) ................................................................. 42 
5.7 Analyzing the Sample (Micro Pipette Adapter, MPA)....................................................... 44 
5.8 Analyzing the Sample (Cap Piercing Device) ...................................................................... 47 
5.9 Analyzing the Sample (Autoloader) ..................................................................................... 48 
5.10 Results................................................................................................................................... 52

 

 

S

ECTION 

6:

  

Q

UALITY 

C

ONTROL 

(QC)

 AND 

B

LOOD 

C

ONTROL 

M

EMORY

 ........................................ 54 

Section Overview ......................................................................................................................... 54 
6.1 Quality Control (QC) ............................................................................................................ 54 
6.2 Levey-Jennings Plots ............................................................................................................. 56 
6.3 Initialization and Use of Xb Function .................................................................................. 58

 

Содержание M16C-US

Страница 1: ...Medonic M series...

Страница 2: ...System Flow 23 3 4 Sample Volume Throughput and Parameters 24 SECTION 4 INSTRUMENT SETUP 25 Section Overview 25 4 1 Menu Selection 25 4 2 Initial Setup 26 4 3 Advanced Setup 27 4 4 Reagent Setup 31 4...

Страница 3: ...ormation Message Indicators 70 9 2 System Information Messages 71 9 3 Parameter Limitations of Automated Blood Cell Counters 73 SECTION 10 TECHNOLOGY 77 Section Overview 77 10 1 Measuring Principles 7...

Страница 4: ...plication Serial number Serial number is located on the rear of the instrument Figure 1 1 Figure 1 1 Figure 1 2 Software version The software version is displayed when starting up the instrument Instr...

Страница 5: ...es and consumables Accessories and consumable lists are available from your local distributor Manufacturer s details Boule Medical AB Domnarvsgatan 4 SE 16353 Sp nga Sweden Website www medonic se Dist...

Страница 6: ...nel authorized by Boule Use only original spare parts and Boule authorized reagents controls calibrators and cleaners If these products are substituted it may void your warranty Operators and laborato...

Страница 7: ...distributor Important Unauthorized modification of the instrument might result in erroneous results or risk for electrical shock Spilling fluids into the instrument might cause electrical malfunction...

Страница 8: ...mediately by pulling out the cord from the main supply 2 Contact your authorized distributor 1 5 Warning Signs in Manual Warning Signs The following warning signs in the manual are used to identify po...

Страница 9: ...quipment Description Signs placed on the instrument define areas that need special attention or areas that contain danger See IVD Symbol Table on page 9 Signs on equipment Figure 1 3 Figure 1 4 Figure...

Страница 10: ...e Use by In vitro diagnostic medical device Lower limit of temperature Upper limit of temperature Temperature limitation CONTROL L 16 CONTROL N 16 Consult instructions for use Control Low control 16 p...

Страница 11: ...ng Operating Placement Environment Description The instrument is packed in a specifically designed protective box Visual Checking Check the box for physical damage If damaged notify your carrier immed...

Страница 12: ...oid lifting the analyzer by the front cover Avoid exposure to sunlight Make sure the instrument has access to proper ventilation The instrument should have at least 2 inches 5 cm of air above it Place...

Страница 13: ...nect the Diluent level sensor red and the electronic sensor to the analyzer Connect the Lyse reagent level sensor yellow and the electronic sensor to the analyzer Plug the power cord into the power ad...

Страница 14: ...put screen and then press EXIT again to return to the Installation Menu Note After reagents are scanned then loosen reagent container caps remove factory seals and place reagent level sensors in respe...

Страница 15: ...e instrument with USB printer cable Printer is not manufactured by Boule See Figure 2 8 Supported Printers USB compatible Supplied by CDS Follow the instructions in the printer user s manual or quick...

Страница 16: ...eagent containers It is recommended that both the Diluent and the Lyse reagents are placed at the instrument level or below Caution Placing the reagent containers above the instrument level could caus...

Страница 17: ...information Caution The end of the waste tubing must be at a lower level than the instrument itself Not following this may lead to improper instrument functions and or waste liquid flowing backwards...

Страница 18: ...en FILL SYSTEM Figure 2 13 Figure 2 14 Figure 2 15 6 The system is now filling up with reagents This cycle will last for approximately 3 minutes Print All Settings After initial setup it is recommende...

Страница 19: ...n or analyze samples No priming or fill cycle is necessary when putting on a new reagent container if indicator and warning messages are followed Important A reagent alarm will display when at least o...

Страница 20: ...es section Contact your authorized distributor in such a case Power interruptions In case of an abrupt power loss there will be no damage done to the instrument Calibration constants and other paramet...

Страница 21: ...orated keyboard and numerical pad 2 Whole Blood probe Aspirates whole blood 3 Pre dilute probe Dispenser Aspirates pre diluted samples and dispenses diluent 4 MPA Micro Pipette Adapter enables the use...

Страница 22: ...on Cal Lots Next Prev Cancel Sampling Device List Pos St SEQ ID Input ID Start Extra Mix Pause Stop Continue Exit 1 4 ABC 2 4 abc 3 4 123 CE 4 4 optional Ok Cancel Reagent Setup Menu Enter New Reagent...

Страница 23: ...PTest Service Setup 2 Exit Service Menu 2 Serial no Firmware Blood Detector Level Detectors Beaker Detector Reagent Detector HGB Shear Valve Needle if applicable CVP if applicable Exit Setup Menu 2 Ba...

Страница 24: ...n Standby Mode Press anywhere on screen to view screen Press EXIT Returns user to last displayed page Press anywhere on screen to view screen Press EXIT to exit standby mode This time amount is user a...

Страница 25: ...ers below Leukocyte parameters WBC Total White Blood Cell Count LYM Lymphocytes percentage LYM Lymphocytes absolute MID Mid Cell Population percentage MID Mid Cell Population absolute GRAN Granulocyte...

Страница 26: ...Topic See Page Menu Selection 25 Initial Setup 26 Advanced Setup 27 Reagent Setup 31 User Interface 33 4 1 Menu Selection Main Menu upon initialization The List Menu will be displayed upon initializa...

Страница 27: ...ect date specific setting 1 DD MM YY 2 YY MM DD 3 YY DD MM 4 MM DD YY 5 Press on the item that you want to change and enter the changes on the numerical pad See Menus below Menus Figure 4 3 Figure 4 4...

Страница 28: ...n option is not available the number will not be accepted when operator presses OK 4 3 Advanced Setup Description Initial advanced setup of the analyzer has been factory set to default values However...

Страница 29: ...t Histograms or 2 With Histograms Note Extended printer format settings and user definable print layouts are also available Please contact local distributor for further detailed information on how to...

Страница 30: ...Type 1 If not set it 0 To use another USB barcode reader other than the one delivered by Boule together with the instrument perform the following Leave the barcode reader unconnected Press the button...

Страница 31: ...etwork 1 USB output with USB device port connector 2 USB memory stick 3 USB RS232 serial port adapter USB connection To connect to a PC computer using a USB connector simply plug in USB connectors bet...

Страница 32: ...2 3 3 2 5 5 7 8 8 7 4 4 Reagent Setup Description This section describes the functions of the reagent setup menu and how to access reagent statistics Reagent Input Enter New Reagents The Medonic M Se...

Страница 33: ...is currently activated The number of cycles left for specific reagent container The Lot and Pack Numbers The expiration date of the specific reagent container The Open Date when the reagent container...

Страница 34: ...then MORE to view specific parameters Press any parameter and select X to block parameter 7 To change RBC PLT discriminators press RBC PLT SETUP to see list and then MORE to view specific discriminato...

Страница 35: ...change analysis profiles input the Authorization Code 2576 Sample Memory The following procedures explain how to search for previous sample analyses and statistics and print send and delete samples St...

Страница 36: ...equence Number From Menu tab press ADVANCED and then SETUP to enter Setup Menu To change sequence number press SEQ NUMBER SETUP press NEXT SEQ NUMBER enter in new sequence number and press OK to save...

Страница 37: ...o obtain accurate results Please follow the recommendation of the EDTA tube supplier Human capillary blood samples should be collected using only high precision pipettes recommended by Boule Limitatio...

Страница 38: ...zardous materials 5 2 Startup Sequence Startup sequence The following sequence guides the operator through the beginning of the day startup routine for the analyzer There are 2 simple steps to follow...

Страница 39: ...a H high indicator press RERUN and follow the screen instructions to analyze background count again Figure 5 3 Figure 5 4 6 When complete the control results are displayed If control results are accep...

Страница 40: ...tinue its cycle Accepted Background values The background count should not be higher than the figures shown below assuming that at least 2 blanks are run after a sample Parameters Values accepted RBC...

Страница 41: ...Sample ID entry and profile selection can be performed up to 30 seconds after sample aspiration Operator ID The Operator ID is an optional feature which can be entered prior to analyzing a sample or w...

Страница 42: ...ean dry lint free absorbent cloth before sample aspiration Not following this technique may impact accuracy if repeating the assay Not removing the sample tube could result in incorrect washing sequen...

Страница 43: ...sis of next sample 5 6 Analyzing the Sample Pre dilution procedure Description This section describes how to analyze a pre diluted sample through the pre dilute aspiration probe and how to use the dis...

Страница 44: ...ter test results Prepare pre dilute sample according to internal documentation and time limitations section above Important In order to get accurate results always use the same dispenser for calibrati...

Страница 45: ...this happens following the instructions below as soon as possible to return analyzer to normal operation status 1 Use dispense mode to dispense diluent into waste beaker until diluent has no traces of...

Страница 46: ...ample or Main menu to begin sample analysis Analyzer must be in one of these operation modes to aspirate 2 Pull out the MPA adapter The instrument will give an instruction to put back the MPA adapter...

Страница 47: ...t use scooping motion or strong repetitive pressure milking to the site This can cause hemolysis or contaminate sample with excess tissue fluid Fill the micropipette completely with fresh whole blood...

Страница 48: ...areful not to wick blood from open ends of the micropipette 6 Follow steps 11 13 above to analyze sample 5 8 Analyzing the Sample Cap Piercing Device Description This section describes how to analyze...

Страница 49: ...used in the Sampling Device A sample wheel adapted for Sarstedt tubes is available as an option The minimum volume in the closed tube should be approximately 1 ml Selecting Sample ID There are several...

Страница 50: ...UT ID 2 Press NEXT or PREVIOUS to scroll to corresponding ID number 3 Manually enter in new ID number using the external barcode reader or the touch screen keyboard Wheel Selection When numerous sampl...

Страница 51: ...If emergency sample has a barcode for ID number align barcode correctly lock sample wheel and press CONTINUE See Editing Sample ID number is manual entry of sample is desired and lock sample wheel and...

Страница 52: ...ART to immediately begin analysis or press EXTRA MIX if extra mixing of samples is needed Default mix setting 10 minutes Extra mixing can be set from 1 to 15 minutes in Setup Menu 3 by choosing MIXER...

Страница 53: ...Sample View 2 Figure 5 28 Continued on next page Press on to view different views of same sample Use these buttons to scroll to previous or next samples Analysis mode and analysis profile Displays da...

Страница 54: ...ample results Press to print current sample analysis Normal Range display with sample results Green bar Results within Range Red bar Results Out of Range Information Indicator When highlighted user ca...

Страница 55: ...or running control samples QC Menu and Assay Value Input Follow the instruction below to access the QC menu and to input Control Calibrator Assay Values from the Assay sheet Step Action 1 Enter the QC...

Страница 56: ...ts should be handled as potentially biohazardous Refer to local regulations and established laboratory protocol for handling biohazardous materials Step Action 1 Follow directions on Assay Sheet to sc...

Страница 57: ...s perform the following steps prior to Step 5 above Scroll to the control sample to be excluded using the PREV and NEXT buttons in the Con Cal Sample or List tabs Then press EXCLUDE INCLUDE button An...

Страница 58: ...7 Figure 6 8 6 A Monthly QC L J Diagram report can also be viewed and printed Follow Steps 5 6 in Section 6 1 to select control lot and month Press L J VIEW to view the monthly diagrams The Monthly L...

Страница 59: ...rams The image below is constructed from several samples and will not be shown as below until a sufficient amount of samples have been analyzed Figure 6 9 Figure 6 10 4 Select MORE to view selected co...

Страница 60: ...ated and exclude instrument failure Verify that instrument maintenance cleaning is current See Sections 8 1 8 3 Prior to calibration print Calibration Log Select ADVANCED from Main Menu then CALIBRATI...

Страница 61: ...List Sample or Main menu to begin calibrator analysis 4 Using installed barcode reader scan the Calibrator ID from the calibrator vial label 5 To perform calibration it is recommended that five calib...

Страница 62: ...USE CAL button which will automatically calculated the new calibration factor using target range from assay values The second method if no calibrator is available is to perform Steps 4 9 using a samp...

Страница 63: ...and a screen will be displayed asking operator if a calibration report is wanted SEND PRINT or EXIT can be selected It is recommended that calibration reports be printed and archived in case it may be...

Страница 64: ...sample analysis Closed tube Device Calibration The closed tube device is calibrated with the calibration of the Open Tube inlet However if the same systematic differences are seen on RBC HGB WBC and P...

Страница 65: ...Daily Cleaning Description The majority of the instruments cleaning procedures are automated to keep the user maintenance to an absolute minimum Warning Always use gloves when in contact with potenti...

Страница 66: ...cle could cause erroneous patient results if system is not cleaned properly Step Action 1 Fill a small container with 5 ml of Enzymatic Cleaner Bottle 1 from Boule Cleaning Kit Note If system has the...

Страница 67: ...for use are supplied with the Boule Cleaning kit solutions The Six Month Cleaning procedure takes approximately one hour and 15 minutes to complete Figure 8 1 Figure 8 2 Figure 8 3 Boule Cleaning Kit...

Страница 68: ...ntainer or drain 2 Reconnect the electrical connections 3 Insert the level sensors back into the reagent containers 4 Power on unit 5 Perform Prime 6 Verify Background 7 It is recommended that the per...

Страница 69: ...iners and follow the instructions for the Boule cleaning kit Instruction is supplied with the Boule cleaning kit solutions 3 After completing the cleaning of the instrument insert the reagent level se...

Страница 70: ...ecurely fastened in the drain Mandatory Action Always use protective gloves when working with the waste container waste tubing and when in contact with potentially biohazardous materials Instrument de...

Страница 71: ...the value is higher or lower than the pre set Normal Range values indicates an out of displayed range parameter the count is too high or too low to measure If it is expected that the parameter is too...

Страница 72: ...Re analyze sample FD RBC PLT Irregular Distribution re analyze It was not possible to find the correct position for the floating RBC PLT distribution curve This flag often occurs on low PLT counts Th...

Страница 73: ...le Reagent and Control Indicators RBC PLT WBC LYM MID GRAN Indicator Message Description Action EC Expired control A control blood was used past its expiry date Use a fresh blood control ER Expired Re...

Страница 74: ...ulation found slide review advised There were more than two modes in the WBC distribution between the LYM L and GRAN H settings 9 3 Parameter Limitations of Automated Blood Cell Counters Description T...

Страница 75: ...excessive numbers This may cause a low PLT count since they might fall within the RBC threshold range Chemotherapy Cytotoxic and immunosuppressive drugs may increase the fragility of these cells whic...

Страница 76: ...o the presence of bi modal populations WBC Limitations Measurement of high WBC levels is influenced by coincidence factors e g counting of two cells as one which may produce falsely low results The in...

Страница 77: ...myeloma The precipitation of proteins in multiple myeloma patients may give falsely elevated WBC counts Large lymphocytes atypical lymphocytes blasts and basophils in excessive numbers The presence o...

Страница 78: ...of the Medonic M Series General Measuring Principles The measuring principles of the Medonic M Series are based on impedance and spectrophotometry principles Whole Blood Dilution The number of cells f...

Страница 79: ...5 10 2 Counting Time RBC WBC Description The counting time is defined as being the time needed for the sample to fill the metering unit from the start to the stop detector Counting Time Limits The nor...

Страница 80: ...population is classified as MID cell area which mainly consists of monocytes See Figure 10 2 below Figure 10 2 Differences in technologies Some 3 part diff technologies use a fixed discriminator analo...

Страница 81: ...alculated from the volume position of the discriminator to 249 fl Be aware that the discriminator might be floating or fixed by the user in the Discriminator set up program In general RBC counts that...

Страница 82: ...treated fresh EDTA whole blood samples within the range of 250 350 10e3 uL As the system uses an orifice size of 80 m diameter coincidence losses will take place with extreme sample RBC PLT counts The...

Страница 83: ...which the desired program is chosen e g discriminator settings Reagents Two external reagent reservoirs are used Isotonic diluent Diluent Hemolyzing reagent Lyse Technology The Medonic M Series is a...

Страница 84: ...IBM proprinter Epson compatible HP PCL 3 and 5 protocol compatible USB printer Control sample memory capacity 1000 control samples Sample memory capacity 1000 samples QC capabilities Mean SD CV Levey...

Страница 85: ...A620 as references Data derived from 965 normal and abnormal fresh blood samples Parameter Correlation Coefficients R2 Advia Medonic WBC 0 98 0 98 RBC 0 97 0 98 MCV 0 98 0 99 PLT 0 98 0 99 HGB 1 00 1...

Страница 86: ...calculated depending on the number of samples per day as shown on the graphs below The figures presented in the graphs assume one exit standby and one wash per day The consumption relation between the...

Страница 87: ...or strange characters 1 Verify that printer type matches the printer being used 2 Verify that the correct paper format has been selected for the printer paper 1 New printer was connected but not match...

Страница 88: ...n selected 1 Serial setup in analyzer is incorrect Results are not being sent to computer after sample analysis 1 Verify that Auto Send Mode is NOT set to 0 1 Auto Print Mode was turned off and not re...

Страница 89: ...ed Standby Power Down and Power Up Informational Displays The system is empty from all liquid and prepared to be filled with other liquid or be stored away Press FILL if you want to refill system or E...

Страница 90: ...the instrument Once activated the instrument is ready to perform an analysis Standby Power Down and Power Up Informational Displays The system is preparing the instrument for analysis mode If the back...

Страница 91: ...spense for best results The instrument is now dispensing 4 5 ml of diluent Please wait The instrument is exiting dispense function Please wait Cycle In Progress Informational Display The instrument is...

Страница 92: ...mpleted as the system still needs to perform wash cycle for an accurate next sample result Please wait until the NEW SAMPLE button is activated If probe was submerged in next sample by mistake perform...

Страница 93: ...reagent will soon need to be changed See Section 2 5 for more detail Instrument displays this notice when reagent container or containers need to be changed Not changing reagents at this time could c...

Страница 94: ...orrectly Perform a prime to prepare the system for analysis Check method for correct instrument power down procedure The system was manually switched off with system emptied of reagents Fill the instr...

Страница 95: ...inserted correctly ComboPack container needs to be changed Not changing reagents at this time could cause erroneous results or possible damage the instrument Connect new reagent container and scan in...

Страница 96: ...barcodes may have been incorrect Verify that setups on the instrument match the required setup for the barcode reader See Section 4 3 and 4 4 for more detail Open Tube Warning Displays The instrument...

Страница 97: ...only be opened in List Sample or Main menu Cap Piercer and Autoloader Warning Displays The Cap Piercer door was opened before the CAP door lock had been activated Close the Cap Piercer door to contin...

Страница 98: ...or service related authorization codes Authorization Code and Installation Warning Displays No authorization code was entered See calibration section in User s Manual for entry of correct authorizatio...

Страница 99: ...ample is taking place 1 Verify that there are no leaks and tubing is connected properly and not kinked 2 Perform valve check in Service Menu 3 Perform clot prevention See Section 8 2 4 If clot prevent...

Страница 100: ...th OK to continue Once OK is pressed and instrument returns to display menus user should repeat previous actions again e g re analyze sample printing results etc If indication error appears again or a...

Страница 101: ...61 62 73 74 83 N NEW SAMPLE 39 40 42 50 91 Normal ranges 33 35 70 O Open Tube 17 24 36 40 41 42 50 59 60 63 82 83 95 Operator ID 34 40 61 Out of Range Indicators 70 P Parameter Limitations 70 73 74 7...

Страница 102: ...iner level 6 Check that waste tube is not pinched or kinked Perform Level Detector Test in Service Menu DF DP flag Re analyze sample DF DP flag DONE NO YES Rotate the units so that no zeros are displa...

Страница 103: ...aintenance Are results still discordant NO YES NO YES YES NO DONE Are reagent levels ok Change out reagent and re analyze sample NO YES Is HCT low compared to spun HCT Check that sample is mixed corre...

Страница 104: ...and wait one minute Turn off analyzer with On Off switch and then turn back on Contact Service Representative DONE Is beep heard when screen is touched Contact Service Representative Remove front cove...

Страница 105: ...Repeat procedure using correct protocol Was monthly or 6 month mainteneance just performed Is maintenance procedure scheduled to be performed Perform scheduled maintenance and re analyze background D...

Страница 106: ...Perform Noise Test under Service Menu Connect cables Are any cables loose on back of analyzer Try plugging analyzer into different outlet Try moving analyzer to another room Are noise values above li...

Страница 107: ...O NO YES YES YES YES YES Perform Orifice Clean in Maintenance menu TU TL flag Perform background count Run a Prime cycles followed by a background count TU TL flag YES Is liquid level above orifice in...

Страница 108: ...t the names of Adobe Systems and Digital Equipment Corporation not be used in advertising or publicity pertaining to distribution of the software without specific written prior permission Adobe System...

Страница 109: ...Art no 1504472 February 2016 Medonic M series Boule Medical AB Domnarvsgatan 4 SE 163 53 Sp nga Sweden Phone 46 8 744 77 00 Fax 46 8 744 77 20 E mail info boule se web www boule se...

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