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USER MANUAL

Rev. 1.1 July 2018

Automated instrument for ESR determination

with modified Westergren method

Only for in vitro diagnostic use

Summary of Contents for cube 30 touch

Page 1: ...USER MANUAL Rev 1 1 July 2018 Automated instrument for ESR determination with modified Westergren method Only for in vitro diagnostic use ...

Page 2: ... DIAGNOSTICA 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 3: ...ests 10294 Test device NEXT 1K 1000 tests 10296 Test device NEXT 5K 5000 tests 10297 Test device NEXT 10K 10000 tests 10403 Thermal paper 20550510 External barcode reader LIST OF MANUAL REVISIONS REV USER MANUAL 0448 DESCRIPTION OF CHANGES 1 0 of 03 2018 Initial revision 1 1 of 07 2018 Description of new functions of settings Troubleshooting update ...

Page 4: ...es CEI 66 8 EN 61010 2 101 Safety for electrical equipment for measurement control laboratory use Part 2 101 Particular requirements for in vitro diagnostic IVD medical equipment EN 61326 1 Electrical Equipment for Measurement Control and Laboratory Use Electromagnetic compatibility requirements Part 1 General requirements EN 61326 2 6 Electrical Equipment for Measurement Control and Laboratory Us...

Page 5: ...2 19 EU directive Attention read the guide follow 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 instrument all the conditions indicated in the relative text must be read and unde...

Page 6: ... is powered using a different cable type from the one supplied which is compatible with the power supply of the country of installation BIO CONTAMINATION HAZARDS Potentially infected material may be handled When analyzing patient samples all precautions must be taken regarding biological risks The samples do not require preparation The samples must be disposed of in accordance with laboratory inst...

Page 7: ...ARE 16 TECHNICAL FEATURES 16 INSTRUMENT COMPOSITION 17 UNIT OF MEASURE 17 INSTALLATION 18 TRANSPORT AND HANDLING 18 PACKAGING CHARACTERISTICS 18 MATERIALS PROVIDED 19 UNPACKING THE INSTRUMENT 20 ENVIRONMENT 20 INSTALLATION PROCEDURE 21 DISPOSAL 22 USE 23 SAMPLE PREPARATION 23 TEST TUBE COMPATIBILITY 23 TEST TUBE LABELING 24 MENU DESCRIPTION 26 HOME 27 PERFORMING AN ANALYSIS CYCLE 28 INSERTING THE ...

Page 8: ...C U B E 3 0 T O U C H U S E R M A N U A L 8 56 Rev 1 1 07 2018 CONNECTION TO HOST COMPUTER 51 BIBLIOGRAPHY 53 ...

Page 9: ...can analyze a load of 30 samples at once or on a random access and continual loading basis By analysing the sample directly from the EDTA blood collection tube multiple samples or sample transfers are not necessary With its colour touch screen the user can select various instrument functions which are described in more detail in the following sections The analysis is fully automated mixing and rea...

Page 10: ...due to the presence of negative electric charge 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 a hepatic level following an inflammatory process or tissue damage the bond of these proteins fibrinogen immunoglobulins with the surface of the red blood cells alters the neg...

Page 11: ...ptic arthritis The erythrocyte sedimentation rate is usually higher in women compared to men 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 4 parts blood to one part anti coagulant The diluted blood is then aspirated inside a special graduated 2 5 mm ...

Page 12: ...he plasma and sedimented cells Materials required for use of the instrument To use the instrument materials must come exclusively from those manufactured by DIESSE DIAGNOSTICA SENESE S p A Always read the instructions for use which accompany each product before its use any other part or accessory used in the instrument may cause damage or incorrect results The manufacturer therefore declines all r...

Page 13: ...th the instrument switched off clean the instrument with a liquid disinfectant used in the laboratory and leave it to dry For the touch screen use a dry microfibre cloth 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 screws...

Page 14: ... of a single body containing all the operating functions necessary for analyzing the sample The instrument has 30 positions arranged in two concentric circles of 15 positions each The test tube carousel is equipped with a plastic adaptor carousel required for use with EDTA tubes with conventional closure Chapter 2 Test Tube Carousel ...

Page 15: ...manually entered with a virtual keyboard or by using an external barcode reader accessory The function of the acoustic warning is to alert the operator during various stages of the operating cycle or in the event of errors This sensor is used to measure the temperature and is fitted in proximity of the test tube carousel The analysis results are printed at the end of each operating cycle or workin...

Page 16: ...ss storage device With the instrument switched off insert the USB device into the appropriate port Fig 6 Power on the instrument and wait for a few seconds The instrument will update automatically Technical features USE Internal use POWER SUPPLY Europe 230Vac 50Hz USA Canada 110 120Vac 60Hz Power output 100VA DIMENSIONS mm 310x470x403 l x w x h WEIGHT 15 kg TEMPERATURE 15 35 C operating 5 45 C sto...

Page 17: ... CATEGORY II Instrument composition The instrument is composed of the following materials expressed in percentages Material in CUBE 30 TOUCH IRON 60 COPPER 3 ALUMINIUM 10 PLASTIC MATERIALS PVC ABS 20 SILICON 2 Gold 0 1 Tantalum 0 2 Cadmium 0 2 Others No Latex 4 5 Unit of measure The units of measure are expressed according to the INTERNATIONAL MEASURING SYSTEM as indicated in the technical standar...

Page 18: ...ansported and handled in its original packaging Do not let the instrument or packaging become wet or be exposed to a damp environment If the packaged instrument has been exposed to storage or transit temperatures below 10 C for more than 24 hours allow the unit to stand at room temperature for one hour prior to installation Packaging characteristics The instrument is packed in 1 an external cardbo...

Page 19: ... cable adherent to IEC International Standards Female Plug IEC 320 C 13 Male Plug Schuko EEC 7 VII Rating 10A 250V AC One power cable SVT PLUG USA OUTLET VDE UL 2mt Two Delayed 5x20 mm UL fuse blocks 10A USB cable Plastic Adaptor A in Fig 7 for use with conventional stopper EDTA tubes Touch screen stylus CUBE pen Inspection Certificate USB key Packing list Fig 7 ...

Page 20: ...tective bag which wraps the instrument 6 Verify that the packing list and supplied materials match Environment For normal safety requirements and given the type of testing it performs the instrument must be positioned in a dust free environment away from heat sources and free from any exposure to liquids Position the instrument on a perfectly level bench not subject to shaking or vibrations Observ...

Page 21: ...n the rear of the instrument Verify the compatibility of external accessories such as a BC reader or USB devices prior to connecting Installation procedure 1 Position the instrument on a solid surface as described above F Fig 10 2 Verify that the power switch is in the OFF position 3 Open the cover unscrew the central knob and remove the stabilizing plate used for transport Insert the plastic adap...

Page 22: ...UMENT AND UNPLUG THE POWER CABLE Disposal The CUBE 30 touch instrument to be functional relies on the use of an electrical power source and therefore in compliance with the EUROPEAN DIRECTIVE 2012 19 CE of July 04 2012 and later amendments by the European parliament it is classified as Electrical Electronic Equipment Disposal of the instrument at the end of its life cycle must be executed in accor...

Page 23: ... mL to 4 mL Whether using the CUBE 30 touch system in the batch or random access mode be sure to mix the samples before starting the test The sample must be mixed gently by complete inversion of the tube a minimum of 8 times so that any air bubble move along the entire tube from one end to the other Do not shake vortex or agitate the sample vigorously as this could cause excessive bubbling or hemo...

Page 24: ...e tube When placing a label on a tube Ensure the label is flattened smooth against the tube Press the label down securely including all the edges and corners to ensure that no part of the label is loose Leave a label free space on the back Excessive thickness and possible wrinkles on secondary labels may increase the test tube s external diameter increasing the risk of a tube becoming lodged in th...

Page 25: ...ure barcode readability tubes must be inserted so that the barcode is positioned toward the mark on the front of each well in the instrument carousel Fig 12 If a secondary label is not used the sample should be inserted so the tube manufacturer s label is facing the mark Fig 12 ...

Page 26: ...e user can access the home page directly HOME when the USER LOGIN function is not active When you turn on the LEDs located around the screen will activate Initially the colors will follow each other then each color will have its own meaning to help the user to understand even at a distance the status of the instrument Purple indicates an analysis cycle is in progress The green color means that the...

Page 27: ... S E R M A N U A L Rev 1 1 07 2018 27 56 HOME Fig 13 From the Home screen the user can access three different functions START Access the START cycle screen ARCHIVE Access archived data SETTING Review edit system some settings ...

Page 28: ...d icons The counter in the top left hand corner of the screen shows the number of tests that can be performed which decreases with each result produced The counter turns red to indicate the last 50 executable tests When the test number is zero new tests cannot be performed To carry out further tests the counter needs to be reloaded using a new TEST DEVICE see the paragraph on Settings ...

Page 29: ...ed in the random access mode during the cycle an individual timer will be displayed on the cap of each added sample Start Begins the analysis cycle Stop Stops the analysis cycle Test tube view Allows the user to view all the samples at the same time Tube view In this mode the user can see the blood level and the actual sedimentation level for each test tube Add Enables the random access mode By pr...

Page 30: ...s shown next to the sample Fig 16 At the end of the barcode reading cycle a window will display the unread positions Fig 17 Fig 17 The user has the following options to select from 1 Open the lid reposition the tube correctly in the carousel press RETRY to have the barcode read again 2 Press the text field and insert the code manually keyboard will appear on the screen Fig 18 and then press OK 3 D...

Page 31: ... U S E R M A N U A L Rev 1 1 07 2018 31 56 Fig 19 The instrument then starts the mixing process and a progress bar displays the time remaining The carousel will make 20 complete rotations 180 to fully re suspend the samples ...

Page 32: ...of each test tube to determine the level of blood at time zero of sedimentation A 20 minute countdown begins at this point with the remaining sedimentation timer located in the centre of the carousel The user may switch from the Carousel view occupied carousel positions are shown in purple to the Tube view tube blood levels are presented ...

Page 33: ...critical to ensure the sample is carefully and properly mixed prior to inserting The CUBE 30 touch does not perform mixing for samples which are added in the random access mode Random Access procedure 1 Press the Add button 2 A prompt to authorize opening the lid will display You can open the cover 3 Open the lid and insert the tube in the position indicated in the prompt which appears on the scre...

Page 34: ... an individual timer which corresponds to its position Fig 23 Note if samples are not loaded within 30 seconds of opening the cover as a safety feature the entire cycle or working session will be aborted The bottom of the display will show Cycle X completed Ready and the instrument will not deduct runs from the counter At the end of the cycle the instrument allows the user to recover the barcodes ...

Page 35: ...24 Results After the test the instrument displays the results for each sample in mm hr in accordance with the classical Westergren method W the default setting Simultaneously the instrument provides an automatic printout and sends results to the LIS if applicable Fig 25 ...

Page 36: ...n the event of errors the sample should be orange coloured and marked ERR Press ERR with your finger to get an indication of the error number see chapter 7 Troubleshooting Printing description manual insertion of the sample barcode not read by the instrument or exclusion of the barcode reading by the user SKIP SKIP ALL sample inserted by the random access mode mixing was not performed by the instr...

Page 37: ...be organized by date or by code ID using the appropriate tab Fig 27 Each sample in the archive has associated with it Date and time of the analysis cycle ID code Cycle number for the day Position occupied in the carousel ESR value mm h By clicking on the Export icon the user can Send to Host Print list Filter the archive by sample ID cycle or date ...

Page 38: ...h as a sample ID or Hematocrit value If HCT values are entered the ESR result will be corrected correction limited to HCT values 40 Any corrected ESR result will displayed with the letter H at the top of the result The Archive QC function is used to access quality control results See chapter 5 SETTINGS The user can access various functions described on the following pages Fig 28 ...

Page 39: ... registered users TEMPERATURE CORRECTION Enable or disable Temperature Correction QC Enter the QC menu to configure quality control settings See chapter 5 THRESHOLD VALUE Set a threshold value when this value is exceeded the instrument will display the result in red to alert the operator that the result is outside of the normal range The default value is 20 mm hr QC DIESSE DECODE Deactivating OFF ...

Page 40: ...xt ARCHIVES BACK UP Back up or restore the archives REFILL Load a certain number of executable tests in the memory Insert the Test Device Fig 28 in the relative compartment and follow the instructions which appear on the screen SERVICE Service menu can only be accessed by personnel authorized by DIESSE Diagnostica Senese SpA Fig 29 ...

Page 41: ...edure To utilize quality control material not supplied by Diesse or Streck 1 Apply dedicated barcode labels 2 Select the item QC from the Settings menu Fig 30 3 Insert the Normal control in position 1 and press the DETECT icon The instrument detects the code and displays it in the barcode window 4 Manually insert the relative data for name lot expiry and acceptability limits 5 Remove the Normal QC...

Page 42: ...QC analysis Control materials are loaded and processed in the same manner as patient samples See chapter 4 The CUBE 30 touch will recognize the barcoded test tube as a QC sample and display it on the screen as shown in Fig 31 Normal control white cap Abnormal control black cap Fig 31 ...

Page 43: ...and may be viewed by clicking on the corresponding number In this screen like the other archives the date code type of control and result are displayed By clicking on the Export icon the user can send to Host print the QC list or filter it by barcode or date By selecting and holding a control record one can display details lot expiration expected assay ranges From this record or from the QC archiv...

Page 44: ...can lead to a failure to comply with established objectives of accuracy and precision The following Westgard rules are commonly used 12s A control value exceeds the mean of two standard deviations 13S A control value exceeds the mean of three standard deviations 22S Two consecutive values exceed the mean of two standard deviations on the same side R4S The difference between two consecutive values ...

Page 45: ...tion about the first user the administrator who will have permissions to add and or remove up to a maximum of 4 users To create a user insert name surname and 6 digit password A 4 character user ID will be generated automatically this ID will identify the user on the instrument s printouts Fig 34 The ID is comprised of the first letter of the person s name the first letter of their last name If it...

Page 46: ...he administrator has the ability to add a new user modify user passwords or to cancel a user Only the administrator can cancel all of the users by selecting the item Reset All Users Only the administrator can disable the safe login function When it needs to be re enabled the administrator and previously registered users will still be stored in the memory Note The only information which can be modi...

Page 47: ...sible and modification of only his her password is possible Note When the safe login mode is enabled a user ID is required upon powering the instrument on The screen shows the list of registered users Select a user from the list that user s name will appear above the text box where the password can be entered Once the correct password has been entered press the fingerprint icon to gain access to t...

Page 48: ...E R M A N U A L 48 56 Rev 1 1 07 2018 Fig 38 The name surname ID of the user who has logged in will appear at the bottom of the screen and on the bottom left of the screen is a Back icon to be used by the active user to log out ...

Page 49: ...fied Check that the test tube in use is compatible with the instrument and that it has been inserted correctly as described in chapter 4 Visually inspect the sample for presence of clumps or clots Err 6 The blood level in the test tube was not detected Err 8 The blood level after the second reading is higher than the initial blood level measured Error Removed tube Err 11 This appears at the end of...

Page 50: ...equired Zero tests remaining Follow the instructions for reloading the instrument with a new test device as described in chapter 4 USB device not found The instrument does not recognize the USB device Remove and reinsert the device or replace it Caution N tests remain The number of remaining tests is less than 50 Be sure to reload the device as soon as possible with a new test device Used TEST DEV...

Page 51: ...r MS Windows will need to be installed to establish communication with the CUBE 30 touch through a virtual COM port on USB On the Cube 30 touch in the Service menu the HOST BY USBD parameter must be set to ON 2 Using a serial RS232 COM on the PC Connect a straight standard serial cable between the PC s RS232 COM port and the instrument s RS232 9 pin serial connector On the Cube 30 touch in the Ser...

Page 52: ...e RS232C DB9 male connector reflects the following pin out Detailed specifics of the communication protocol are available for consultation on the web site at the following address www diesse it CUBE 30 Touch SPECIFICATION PROTOCOL PIN SIGNAL 2 Rx of date from Host 3 Tx of data towards Host 5 GND ...

Page 53: ...in Pathol 1977 68 4 505 507 6 ICSH Guidelines on Selection of Laboratory Tests for Monitoring the Acute Phase Response J Clin Pathol 1988 41 1203 1212 7 ICSH recommendations for modified and alternate methods measuring the erythrocyte sedimentation rate Kratz A Plebani M et all Int J Lab Hematol 2017 Oct 8 Clinical and Laboratory Standards Institute H26 A2 Validation verification and quality assur...

Page 54: ... E 3 0 T O U C H U S E R M A N U A L 54 56 Rev 1 1 07 2018 697 Definition of erythrocyte sedimentation using Micrococapillary tube 12 NCCLS H02 A5 Procedures for ESR approved standard fifth edition Punto 4 2 ...

Page 55: ...E 3 0 T O U C H U S E R M A N U A L Rev 1 1 07 2018 55 56 Attachment A CEDeclarationofConformity The current version of the CE Declaration of Conformity may be downloaded from the DIESSE website www diesse it ...

Page 56: ...C U B E 3 0 T O U C H U S E R M A N U A L 56 56 Rev 1 1 07 2018 ...

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