Diesse 10392 User Manual Download Page 1

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Rev 1.3 06/2018 1/59

USER MANUAL

Software Release No. 1.xx

Rev. 1.3 issued on June 2018

Automatic instrument for ESR determination

with modified Westergren method

Only for in vitro diagnostic use

Summary of Contents for 10392

Page 1: ...Rev 1 3 06 2018 1 59 USER MANUAL Software Release No 1 xx Rev 1 3 issued on June 2018 Automatic instrument for ESR determination with modified Westergren method Only for in vitro diagnostic use ...

Page 2: ...M I N I C U B E U S E R M A N U A L Rev 1 3 06 2018 2 59 ...

Page 3: ...AGNOSTICA SENESE S p A Via delle Rose 10 53035 Monteriggioni SI Italy Tel 39 0577 587111 Fax 39 0577 318690 WWW DIESSE IT REGISTERED AND ADMINISTRATIVE OFFICE Via A Solari 19 20144 MILANO Tel 39 02 4859121 Fax 39 02 48008530 For technical assistance please contact your distributor ...

Page 4: ...CUBE Printer 10404 MINI CUBE Thermal paper for Bluetooth MINI CUBE printer 20550510 External barcode reader 30006190 MINI CUBE USB to Serial adapter List of User Manual REVISIONS REV USER MANUAL 00417 DESCRIPTION OF CHANGES 0 of 01 06 2016 Initial revision 1 of 01 10 2016 Chapter 3 composition of the istrument 1 1 of 25 01 2017 Modification of the list of manuals revision and drafting of the docum...

Page 5: ...l equipment for measurement control laboratory use Part 2 101 Particular requirements for in vitro diagnostic IVD medical equipment 2014 35 EC Low voltage directive 2014 30 EC Directive on the harmonisation of the laws of the Member States relating to electromagnetic compatibility 2011 65 EU Directive on the restriction of the use of certain hazardous substances in electrical and electronic equipm...

Page 6: ...g to L D 25 07 2005 no 151 Italy implementation of the directives 2002 96 EC and 2003 108 EC Warning read the manual observe the safety symbols Caution risk of electric shock Legend of symbols used in this document WARNING potential risk of personal injury all the conditions indicated in the relative text must be read and understood before proceeding CAUTION potential risk of damage to the instrum...

Page 7: ...o longer be guaranteed when the instrument is powered using a different cable from the one supplied compatible with the power supply of the country of installation BIO CONTAMINATION HAZARDS When an analysis system like the MINI CUBE is used all precautions must be taken regarding biological risks The samples do not require preparation The samples must be disposed of in accordance with laboratory i...

Page 8: ...LS PROVIDED 18 UNPACKING THE INSTRUMENT 19 SETUP 20 INSTALLATION PROCEDURE 20 LIMITATIONS AND WARNINGS 21 COMPOSITION OF THE INSTRUMENT 21 DISPOSAL 21 USE 22 COMPATIBLE TEST TUBES 22 PREPARATION OF THE SAMPLE 22 TEST TUBE LABELLING 23 DESCRIPTION OF THE MINI CUBE MENU 24 PERFORMING AN ANALYSIS 25 INSERTING THE TEST TUBES 26 STARTING THE ANALYSIS CYCLE 27 ARCHIVE 29 SETTINGS 33 QUALITY CONTROL 36 P...

Page 9: ... directly from the EDTA tube The instrument analyzes four blood samples simultaneously on a random access and continual loading basis The color touch screen allows the user to select various instrument functions which are described in more detail in the following sections ESR results obtained in only 20 minutes show excellent correlation to the Westergren Reference method at one hour ref 1 10 Fig ...

Page 10: ... move apart due to the presence of negative electric loads from the numerous residues of sialic acid present at a membrane glycoprotein level When the protein composition of plasma changes with the production of acute phase proteins at hepatic level following an inflammatory process or tissue damage the bond of these proteins fibrinogen immunoglobulins with the surface of the red blood cells chang...

Page 11: ...osis and septic arthritis The ESR in usually higher in females compared to males and increases in pregnancy and tends to rise with age in both genders Normal ESR values Westergren citrated With the Westergren reference method the test is performed on blood diluted in citrate with four parts blood to one part anti coagulant The diluted blood is then aspirated in a special graduated 2 5 mm diameter ...

Page 12: ...CUBE system offers a closed tube system which provides less exposure to potentially infectious samples however all necessary precautions and personal protective equipment for handling biological material apply Waste material should be disposed of in accordance with your local waste requirements Maintenance procedure The MINI CUBE is designed to require minimal maintenance For any type of maintenan...

Page 13: ...etergent and leave to dry 2 Repeat the operation with 70 isopropyl alcohol 3 Leave the instrument turned off for at least 1 hour before starting a new operating cycle or carrying out any other operation on the instrument Do not attempt to remove any of the screws or open the instrument and or clean the interior Please contact Technical Services for further instruction DECONTAMINATION PROCEDURE ...

Page 14: ...ne per position to verify the suitability of the sample and detect the level at baseline and level after 20 minutes of sedimentation The optical sensor of each position scans the inserted test tube checking that it contains an adequate volume of blood and identifying the type of tube 4 ml EDTA or 500 µl microtainer EDTA The function of the alarm is to alert the operator during various stages of th...

Page 15: ...E has a Bluetooth 4 0 connection for an external printer optional accessory or for connection to a mobile device The power supply serial USB port for connection to the computer a USB port for connection to the USB mass storage device B that can be used to update software or export files and port for the external bar code reader are positioned at the rear The functional units of the module are desc...

Page 16: ... NOISE LEVEL below 80 decibel LEVEL OF POLLUTION 2 pollution degrees MEASUREMENT RANGE from 0 to 140 mm hr for paediatric tubes from 0 to 60 m hr CENTRAL UNIT ARM Cortex M4 180 MHz Microprocessor DISPLAY 480x272 TFT 16 7 Million colors Resistive Touch Panel OPTICAL UNIT 4 pairs of optical elements photodiode phototransistor INTERFACES USB CLASS OF DEVICE III SAFETY STANDARDS CEI EN 61010 1 CAN CSA...

Page 17: ...The instrument must be transported and handled in its original packaging Do not leave the packed instrument in a damp environment or allow the boxed package to get wet If the instrument has been subjected to temperature conditions below 10 C for more than 24 hours allow the instrument to sit at room temperature for one hour prior to installing powering on Packaging characteristics The instrument i...

Page 18: ...nual USB mass storage with multi lingual manual Non capacitive touch stylus DC power Supply see characteristics in Technical Features section One power cable for each module according to IEC International Standards Female Plug IEC 320 C 13 Male Plug Schuko EEC 7 VII Rating 10A 250V AC USB cable Certificate of Analysis Packing list Fig 3 0 ...

Page 19: ...the packing labels and remove the accessories Fig 3 1 2 Remove the instrument and power supply unit from the box 3 Remove the expanded polyethylene blocks containing the instrument and power supply unit Fig 3 2 4 Remove the protective pack from the instrument 5 Verify the materials supplied against the packing list ...

Page 20: ...o not have CE marking The safety of the instrument and of the operator is not guaranteed if one or more of the following conditions are violated The mains must be compatible with the voltage and current specifications indicated on the metal plate affixed below the instrument Before connecting external accessories BC reader printer USB sticks check the compatibility Installation procedure Only use ...

Page 21: ...instrument is made up of the following materials expressed in percentages Material in MINI CUBE IRON 10 COPPER 3 ALUMINIUM 60 PLASTIC MATERIALS PVC ABS 20 SILICON 2 Gold 0 1 Tantalum 0 2 Cadmium 0 2 Others No Latex 4 5 Disposal The MINI CUBE instrument relies on the use of an electrical power source and therefore in compliance with the EUROPEAN DIRECTIVE of 27 January 2003 and later amendments by ...

Page 22: ...n the Microtainer Tube The test must be performed within 4 hours of collection with the sample at room temperature 18 25 C The test may be performed on blood samples stored at 2 8 C for a maximum period of 24 hours Ensure that the sample is at room temperature for 15 minutes and well mixed prior to inserting into the instrument and performing the test Preparation of the sample Before starting a te...

Page 23: ... tubes with a maximum of 1 secondary label adhered as close to the lavender EDTA cap as possible and with a label free gap one side As the samples are loaded it is important to align the label free gap with the dot on the insertion ring so the label free gap is towards the right of the analyzer fig 4 0 Fig 4 0 ...

Page 24: ...urn on the MINI CUBE HOME Fig 4 1 It is recommended to use a stylus on the touch screen display Once powered on the Home page Fig 4 1 is displayed to access the following functions START Tap this icon to go to the Analysis screen and run a sample ARCHIVE Tap this icon to view the data archive SETTING Tap this icon to view change instrument settings ...

Page 25: ...number of tests remaining in the MINI CUBE For each result produced the instrument decreases the number of tests available by one The counter font colour will change depending on the number of tests remaining green font indicates that more than 50 tests are available red font indicates less than 50 tests are available When the test number is zero new analyses cannot be performed Load a new TEST DE...

Page 26: ...r via Bluetooth Once the printer is powered on go to Settings and note that the Bluetooth and auto print option default to on Select the Bluetooth arrow and the system will search for the wireless printer Select MSP 100P The status will change from Searching to Connected OFF Powers off the LEDs and returns to the main screen Information Select to open an interactive guide on instrument operation I...

Page 27: ...the tube To enter the Patient ID or Sample ID manually after inserting a test tube touch the test tube on the display to open the Sample ID window Touch the desired field enter the appropriate code and confirm the data before it is saved To associate a Patient ID with an archived patient result click on the Archive icon to search for the patient After entering the code it can no longer be edited f...

Page 28: ...reduced while a sample is running At the conclusion of the test 20 minutes the instrument will alarm to alert the user that analysis is complete and the result will be displayed above each position Fig 4 4 To cancel a run either remove the tube and an immediate Err message will display or press the OFF icon and a prompt will read There are X sample s in process Are you sure you want to stop the an...

Page 29: ...nu ARCHIVE Fig 4 5 The archive consists of the Patients Archive Results Archive and QC Archive Each archive can contain up to 5000 records In the Patients Archive you can search for a patient by name surname and patient ID clicking on the relative key in succession entering the first letters or complete name in the specific search bar Click on the export icon to print a list of patients create a n...

Page 30: ...e date and time of the analysis cycle the position occupied and the ESR result If a sample has been recognized as a Pediatric tube a P in subscript will be displayed immediately to the right of the ESR value on the screen and PEDIATRIC will be indicated on the sample printout If Hematocrit correction is enabled an H will be displayed in superscript immediately to the right of the result The Hct re...

Page 31: ...ts To go to a patient record Fig 4 7 hold down the string containing the patient name Fig 4 7 Name Displays the patient Name and Surname SEX Patient gender DOB Patient Date of Birth PATIENT ID To insert the patient code in the Patient ID field e g health card number or tax code the barcode on the card needs to be scanned or edited manually If a code is not available the instrument will generate on...

Page 32: ...is perfomed with temperature correction enabled If temperature correction is disabled the temperature is displayed in red ESR RESULT Result of the ESR test and relative reference scale DAS 28 this displays the DAS28 results EXPORT Prints the patient record DAS 28 This takes you to the DAS 28 menu See chapter 7 From any screen press the Arrow Back icon on the bottom left side of the display to retu...

Page 33: ...M I N I C U B E U S E R M A N U A L 33 59 Rev 1 3 06 2018 Fig 4 8 SETTINGS Fig 4 9 ...

Page 34: ...calculate the DAS 28 for analysed samples LANGUAGE Select language options are English Italian Dutch or Spanish TEMP SCALE Choose from Celsius or Fahrenheit DATE TIME Set the date and time format REFERENCE Indicate the reference scale to be used for test results Westergren or Panchenkov TEMP CORR Enable or disable Temperature Correction See chapter 1 for explanation of temperature correction THRES...

Page 35: ...e archives REFILL Load a certain number of executable tests in the memory using the TEST DEVICE NEXT Check Device Transponder fig 4 10 Fig 4 10 In this sub menu the user can load more tests by inserting the transponder in the slot at the base of the instrument and following the instructions displayed on the screen fig 4 10 Fig 4 11 SERVICE Service menu that can only be accessed by personnel author...

Page 36: ...ontrol for ESR is used labels with dedicated bar codes should be created and the data entered manually Fig 5 0 It s recommended to run two levels of control each day of patient testing with the Diesse MINI CUBE In the QC archive the user can view the historical QC data Results are stored by the position in the instrument and may be viewed by clicking on the corresponding number Similar to the othe...

Page 37: ...ings chart Fig 5 1 Fig 5 1 This screen displays the QC information including the number of measurements performed the average standard deviation and the CV The Levey Jennings chart displays the control data points on the x axis and the mean and standard deviations 1SD 2SD are shown on the y axis WESTGARD statistical rules are commonly used by laboratories to evaluate their data set and identify sy...

Page 38: ...nsecutive values fall on the same side compared to the mean Press the Export icon to print the list of data of for a selected control or to search and filter by lot Performing QC analysis Control materials are processed in the same manner as patient blood sample See chapter 4 To run a QC sample scan the QC barcode previously recorded in the settings menu and then load in any free position The MINI...

Page 39: ...ample Low The sample blood level too low The minimum volume is 2mL High The sample blood level is too high or there could be an issue with the secondary label number of labels or thickness Refer to Chapter 4 for the ideal label placement Exam not available Need refill No tests remaining Refer to Chapter 4 to load a new transponder Printer error Retry The printer could be OFF Turn ON the printer or...

Page 40: ...tions hemolysis or any pathological condition that interferes or prevents a clear red blood cell to plasma interface should be determined by the clinician ordering the test Manual and automated ESR measurements in samples without a clear interface are subject to a high degree of variability In the MINI CUBE the sample may go undetected or yield variable results Visually inspect the sample at the c...

Page 41: ... with new scar tissues that cause the rigidity and deformation commonly found in rheumatoid arthritis Typical symptoms of the disorder include muscle weakness and anaemia swelling and pain of the joints fatigue weight loss and fever Rheumatoid Arthritis typically affects the joints symmetrically i e both wrists elbows or knees The cause of rheumatoid arthritis is still unknown so it is not possibl...

Page 42: ...These criteria are A the number of painful joints B the number of swollen joints C measurement of the ESR D determination of functional disability based on a Health Assessment Questionnaire HAQ E the degree of pain reported by the patient expressed on a faces pain visual analog scale VAS for pain F the doctor s score of the overall degree of activity of the disease expressed on a visual analog sca...

Page 43: ...is applicable to an evaluation of disease activity at a given moment High disease activity 5 1 Moderate disease activity 3 2 to 5 1 Low disease activity 2 6 to 3 2 Remission 2 6 Ref http www das score nl das28 nl uitleg das28 de das28 score html evaluation of the modification of disease activity over time Besides measuring the ESR the MINI CUBE can also calculate the DAS28 This feature makes the M...

Page 44: ...g to the Results archive and hold down the string containing the result Patient Data menu The home page shows the date and time of the ESR analysis and the ESR result for the patient To indicate the number of painful joints enter the number directly in the box or touch the body image outline on the left side of the screen underlined orange ...

Page 45: ... U B E U S E R M A N U A L 45 59 Rev 1 3 06 2018 Fig 7 1 An enlarged image is displayed to identify the points Touch the right or left hand images for details of the joints as shown in the figure Fig 7 2 Fig 7 2 ...

Page 46: ...ow to advance through all images When done click the green return arrow to go back to the main page The same procedure is used to identify swollen joints Besides manually entering information the user can click on the body image outline on the right side of the DAS28 home screen underlined purple to display an enlarged image to identify painful areas Fig 7 3 Touch the right or left hand for detail...

Page 47: ...as and these will turn purple Lastly the patient must rate their general well being on a scale from 0 very well to 100 very poor After entering all data the DAS28 will be displayed according to the following colour scale When the DAS28 feature is enabled the DAS28 calculation will appear below the ESR result on the instrument printout 2 6 REMISSION 2 6 3 2 MILD 3 3 5 1 MODERATE 5 1 HIGH ...

Page 48: ...cal data on the sample Fig 7 5 Fig 7 5 The chart shows the month and year when measurements were taken on the x axis and DAS28 values on the y axis A vertical blue line indicates the corresponding point for the date selected in the list below which lists all analyses for the patient Click on export to print the entire page displayed ...

Page 49: ...be installed on the PC To set the communication with the MINI CUBE through a virtual COM port over USB On the MINI CUBE the parameter HOST BY USBH has to be set OFF in the Service Menu 2 Using a serial RS232 COM port on the PC In this case the MINI CUBE USB to Serial adapter has to be used Connect a standard RS232 straight Cable between the PC RS232 COM port and the Adapter s Serial Connector Then...

Page 50: ...of 0x7A is represented by two ASCII characters 7 0x37 and A 0x41 the first represents the most significant nibble and the second the least significant Examples Original Byte Representation HEX ASCII Hexadecimal value H characters L characters 0x45 4 0x34 5 0x35 0xC8 C 0x43 8 0x38 0x6F 6 0x36 F 0x46 0x10 1 0x31 0 0x30 As can be seen this type of representation means that two ASCII characters are ne...

Page 51: ...D H CHK L CHK The hexadecimal values indicated in brackets are constant values for this message The fields in bold print are the variable ones and are described below H LEN L LEN Length of the data field from Data 1 to Data n inclusive represented in HEX ASCII Maximum value F 0x46 F 0x46 This is the effective number of bytes contained in the data field The maximum number of bytes contained in the ...

Page 52: ...ator DDMMYY where DD day of the month from 01 to 31 ASCII MM Month of the year from 01 to 12 ASCII YY Year of the century from 00 to 99 ASCII TIME ANALYSES string of 4 characters without terminator hhmm where hh hour of the day from 00 to 23 ASCII mm Minutes from 00 to 59 ASCII VES Value of the VES measured ASCII string without terminator from 0 3 spaces 0 transmitted in the case of an error to 14...

Page 53: ...Flag enabled Bit 3 set to 1 the result VES 0 must be interpreted by the Host as a Reading Error of the sample RACK ID Not Used always 0000 string of 4 characters without terminator POSITION string of 2 characters without terminator identifies the position occupied by the sample into the instrument 01 04 H CHK L CHK CheckSum of the message represented in HEX ASCII The Checksum is calculated by carr...

Page 54: ...ERR L ERR ETX 0x0D where H ERR L ERR are the HEX ASCII representation of the error code defined according to the following table Error code H ERR Value L ERR Value Meaning 0x00 0x30 0x30 General Error 0x04 0x30 0x34 Checksum Error 0x05 0x30 0x35 Error field value H LEN L LEN 0x06 0x30 0x36 Data field Length Error Timeout on NACK Message 1 Sec Message for sending QC Quality Control sample data Comm...

Page 55: ...mum Value F 0x46 F 0x46 This is the effective number of bytes contained in the data field In fact the maximum number of bytes contained in the DATA field is 255 Data 1 Data n Data field The Data field for the message code 0x52 consists of the following QC data QC Record Sample QC data Batch No ASCII string 6 characters EXPIRY DATE ASCII string 6 characters H VALMIN L VALMIN H VALMAX L VALMAX BATCH...

Page 56: ...allowed This is the barcode just as it is read by the Mini Cube Barcode Reader TERMINATOR the string of barcodes terminates with the 0x10 byte This is because the length of this string is variable DATA ANALYSES string of 6 characters without terminator DDMMYY where DD day of the month from 01 to 31 ASCII MM Month of the year from 01 to 12 ASCII YY Year of the century from 00 to 99 ASCII TIME ANALY...

Page 57: ...s will have a 0x01 hexadecimal value and its HEX ASCII representation will be 0x30 0x31 In the case of a QC Fail error the Bit 5 will be set to one and all the others to zero therefore the byte of the Flags will have a 0x20 hexadecimal value and its HEX ASCII representation will be 0x32 0x30 RACK ID string of 4 characters without terminator identifies the classifier rack in which the sample has be...

Page 58: ...CSH Guidelines on Selection of Laboratory Tests for Monitoring the Acute Phase Response J Clin Pathol 1988 41 1203 1212 7 Clinical and Laboratory Standards Institute H26 A2 Validation verification and quality assurance of automated hematology analyzers Approved Standard Second Edition 8 Westgard JO Basic QC Practices Training in Statistical Quality Control for Medical Laboratories Third Edition 20...

Page 59: ...I C U B E U S E R M A N U A L 59 59 Rev 1 3 06 2018 The current version of the CE Declaration of Conformity may be downloaded from the DIESSE website http www diesse it en action action download file id 7693 ...

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