Summary of Contents for Cypress Diagnostics CYANHemato
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INSTALLATION REPORT AND CHECKLIST For analyzer CY006 CYANHemato (Company name) Distributor (Country, city) Coordinates (Telephone and Email) (Name) Maintenance engineer (Telephone and Email) (Laboratory name) Institution (Country, city) Coordinates (Telephone and Email) (Name) Lab manager (Telephone and Email) Installation report Serial number Delivery date Installation date □ □ Content packing list verified Yes No Installation checklist completed □ □ ...
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Checklist for installation (detailed instructions in chapter 3 of the user manual) Ensure optimal operation □ Verify the location specifications □ Check the electronical current requirements. If necessary, use: □ Electronic stabilizer □ UPS Installation of accessories on the CYANHemato analyzer □ Connect the 3 reagents: diluent, lyse and cleaner and the waste tube to the waste bottle □ Connect any peripherals: external printer, keyboard, mouse □ Install printing paper □ Install the correct tube adaptor □ Connect the power cord to a suited power supply Verification of the CYANHemato analyzer □ Perform a priming cycle for all reagents □ Run a selftest to check the instrument’s performance □ Run blank measurements to exclude background noise (three blank measurements) □ Perform a calibration with normal control (at least three measurements) □ Perform a quality control with low, normal and/or high control blood Adaptation of the system to the customer □ Configure language, heading, measurement units, normal ranges, date and time □ Create user profiles ...
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CY006 CYANHemato User Manual For a clear and precise diagnose ISO 13485-2016 www.diagnostics.be • Belgium • Tel: ++ 32 15 67 67 68 • e-mail: cypress@diagnostics.be Layout 20181024...
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.......................... 1 7 NSTALLATION 3.3.1 Location specifications ............................. 18 3.3.2 Install the reagents and the waste bottle .................... 18 3.3.3 Install any peripherals ............................ 20 3.3.4 Install or change the print paper for the buildin printer .............. 21 3.3.5 Install the required sample holder ....................... 21 3.3.6 Connect the power supply .......................... 22 3.3.7 Turn ON the instrument ........................... 23 3.3.8 Verify the instrument ............................ 24 3.3.9 Adapt the system to the user ......................... 24 3.3.10 Give extensive explanation to the user! .................... 24 3.3.11 Shutdown ................................. 25 CYANHemato user manual Rev. (7.0), 202111 Page 1 ...
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DAILY ROUTINE ........................ 73 5.1 P ........................ 7 3 REPARATIVE 5.1.1 Preparation of the analyzer .......................... 73 5.1.2 Preparation of control blood for calibration and/or quality control .......... 73 5.1.3 Preparation of blood samples for analysis .................... 73 5.2 S .......................... 7 4 TART ANALYSIS 5.2.1 Blank measurement ............................ 74 5.2.2 Quality control measurement ........................ 75 5.2.3 Sample measurement ............................ 76 CYANHemato user manual Rev. (7.0), 202111 Page 2 ...
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6.2.3 Cleaning of the outside of the instrument .................... 80 6.3 P .......................... 8 0 ERIODICALLY 6.3.1 Disinfection / Emergency cleaning ...................... 80 6.3.2 Hard cleaning of the needle ........................... 82 TROUBLESHOOTING ...................... 83 7.1 O .......................... 8 3 PERATIONAL 7.2 T ............................ 8 8 ECHNICAL HYDRAULIC DIAGRAM ...................... 90 REAGENT INSERTS CONSUMABLES CYANHemato user manual Rev. (7.0), 202111 Page 3 ...
! WARNING! Please read the user manual before operating the CYANHemato and make sure the installation and maintenance are performed correctly. Note: If the installation, usage and maintenance directions are not followed correctly and/or safety indications are not respected, Cypress Diagnostics cannot guarantee correct functioning of the ...
EAGENTS The CYANHemato is a closed system, only reagents supplied by Cypress Diagnostics can be used on the CYANHemato and vice versa. If other reagents are used on the CYANHemato or if the reagents are used on a different analyzer than the CYANHemato then the accuracy cannot be guaranteed. Diluent (Code: CY006R01): Isotonic saline solution, used to dilute whole blood samples and to rinse the fluidic system between measuring procedures. Lyse (Code: CY006R02): Creates hemolysate for 3part WBC differential and for HGB measurement. Cleaner (Code: CY006R03): For cleaning process of the fluidics. Cypress Diagnostics also offers emergency cleaners. These emergency cleaners are not designed for regular cleaning, but should be used in case of problematic blank measurements. Hypoclean (Code: CY006R04): Hard cleaner (bleachbased). Clenz (Code: CY006R05): Enzymatic cleaner. Hypoclean CC (Code: CY006R06): Hard cleaner, used to clean the sample needle. Note: the inserts of the different reagents can be found in the appendix of this user manual. UALITY ONTROL LOOD The analyzer allows the continuous monitoring of measurement performance with control blood ...
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1.6.2 Sample storage The anticoagulant requires some time (1530 minutes) to stabilize its effect and completely stop the coagulation process from starting. Blood samples should be run on CYANHemato only after this reaction time has elapsed. Blood samples can either be collected and analyzed at the same spot (making sure that the anti coagulant’s reaction time is guaranteed) or can be analyzed at an offsite location. The collected samples can be kept at room temperature (15 – 30°C) for up to 8 hours. If the samples ...
If the same sample needs to be measured multiple times, please mix the sample gently before every sampling (invert the tube at least 8 times). Make sure to wipe the cap clean before placing it again on the vial. 1.6.4 Sample handling Blood samples must always be considered as biohazard and infectious biological material. It is recommended to wear protective gloves and goggles. Spilled blood must be cleaned up as soon as possible, and the surface in contact with it must also be cleaned with a suitable sanitizer. YSTEM ESCRIPTION The CYANHemato is a microcomputerbased independent unit, composed of three main units: 1. Fluidic System Performs sampling, diluting, mixing and lysing operations. Generates the regulated vacuum used for moving cells through the aperture during counting. 2. Data Processing System counts, measures and calculates blood cell parameters, generates and stores numerical results and histograms. 3. Control Panel Features an LCD touch screen START button, status LED, and USB port interfaces. CYANHemato user manual Rev. (7.0), 202111 Page 7 ...
Blood sample can be removed when the LED blinks red 3 times and the RED BLINKING instrument beeps 3 times. The analyzer is currently performing an analysis. No new measurement can be RED started. The analyzer is performing a maintenance process. ORANGE The instrument is in standby and the display light is off. Hit the screen to wake ORANGE BLINKING up from standby. 1.7.3 LCD Touch screen The display is a 320 x 240 dots, high contrast backlit highcolor graphic LCD module, with integrated touch screen. A finger or smaller blunt object (stylus pen) should be used to operate the touch screen. If the operator gently touches the LCD, the analyzer will recognize the position where the screen was pressed; the software will activate the corresponding function/menu/button. ! ATTENTION POINT! The screen can only react to one touch point at the same time. If something else is touching or pressing the screen (on an empty position), it will not respond to your touch! 1.7.3.1 EYBOARD When data needs to be entered, a keyboard will appear. The keyboard will be adapted to the data that can be entered in that specific area; alphanumeric or numeric only. CYANHemato user manual Rev. (7.0), 202111 Page 8 ...
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1. Gently tap and continuously hold any empty location on the touch screen for at least 30 seconds. 2. After ca 30 seconds, a calibrating screen appears. Tap the middle of the cross of the reference points one after another. If you made an error, you will hear an error beep, and the process restarts. If the calibration was successful, the software will return to the original screen. ! ATTENTION POINT! Make sure not to press it hard, otherwise you can damage the screen 1.7.4 Buildin thermal printer The CYANHemato is equipped with a builtin thermal printer. The text or graph is printed on coated thermochromic paper. This paper is selectively heated when passing over the thermal printing head, and thereby the coating on these places turns black, producing an image. One of the big advantages of a thermal printer over a normal printer is that it does not require expensive consumables like a toner. Press the feed button to move the paper forward without printing. ...
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1.7.5 Power supply The analyzer is equipped with an external power supply. The power supply module has a socalled auto range input, allowing operation on 230V or 115V power systems. The power supply unit complies with CE safety certifications. The input socket is a standard power cable connection and the output is a DC jack. Note: Only use the provided power supply with the instrument. 1.7.6 Back label Every instrument has its own serial number, which is printed on the back label and can also be found in the Device Information submenu. Please mention this serial number in every communication. CYANHemato user manual Rev. (7.0), 202111 Page 10 ...
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6 controls programmable Separate QC result menu with (printable) graphs Calibration methods 1 or more automatic measurements or manual calibration of WBC, HGB, RBC, PLT, MCV (or HCT), RDW, and MPV Data storage 10.000 results, with RBC, PLT, and WBC 3part histogram Data backup method USB mass storage device Languages English, French, Spanish, Portuguese, Russian, Indonesian, German Software upgrade method via USB A port using USB mass storage device User interface LCD Touchscreen Separate START button Red/green status indicator LED Possibility of external USB keyboard via USB A port Possibility of external USB mouse via USB A port CYANHemato user manual Rev. (7.0), 202111 Page 11 ...
Support for HP printers (DeskJet, LaserJet, PCL3, PS, LIDIL) Power supply External power supply unit autoranging power unit for 100120 or 200240 VAC, 50 60Hz Power requirement 12VDC, 5A, 60W max. Grounding required Weight and dimensions Instrument: 12 kg, 320 x 260 x 365 (LxWxH) Packed in box: 18 kg, 405 x 480 x 565 mm (LxWxH) Environmental requirements Ambient temperature: 18°C – 30°C, optimal temperature 25°C Reagent storage temperature: 1830°C Relative humidity: 45 % 85% Altitude below 3000m (9000 ft) IMITATIONS OF USE After turning on the instrument, pay attention not to spill liquids on the surface around the instrument. Keep the instrument away from children. 1.10 ANDLING IN CASE OF EMERGENCY In case of emergency situation like instrument on fire due to shortcircuit immediately cut off the power by disconnecting the main power or DC input line, and use a fireextinguisher if necessary. 1.11 R EGULATORY COMPLIANCES The CYANHemato complies with European Directive 97/79/CE for In Vitro diagnostic CYANHemato user manual Rev. (7.0), 202111 Page 12 ...
DILUTION RATES USED MEASUREMENT TIMES MIX dilution 1:160 WBC count 12 seconds WBC dilution (depends ~1:196 HGB measurement 3 seconds on amount of lyse) RBC/PLT dilution 1:32 000 RBC/PLT count 12 seconds RINCIPLE OF THE HEMOGLOBIN MEASUREMENT The lysed sample dilution can be measured by a photometric method. The reagent lyses the red blood cells, which releases hemoglobin. The chemical process forms a stable form of methemoglobin. This is measured photometrically at 540 nm through the chamber. All Cypress Diagnostics branded reagents are cyanidefree. However, some reagents from other manufacturers may contain cyanide. In that case, cyanide and any other chemical composition formed CYANHemato user manual Rev. (7.0), 202111 Page 13 ...
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. The cells to be counted are diluted till a single cell suspension in a fluid which conducts electrical current. By creating vacuum, they are sucked one by one through a special narrow opening, called an aperture. Flanking the aperture are two electrodes that conduct electricity. When no cell is in the gap, electricity flows unabated, but when a cell is sucked through the aperture, the current is resisted. The Coulter counter counts the number of such events and also measures the pulse in the current (and hence the resistance), which directly correlates to the volume of the cell trapped. By monitoring such pulses in electric current, the number of particles for a given volume of fluid can be counted. The size of the electric current change is related to the size of the particle, enabling a particle size distribution to be measured. The volume distribution of the cells is displayed on diagrams: WBC, RBC, and PLT histograms. ARAMETERS The CYANHemato measures and calculates 20 parameters. Name Abbr. Units Description and/or calculation White Blood Cells WBC cells/l, cells/µL Number of leukocytes WBC = WBC x counted WBC WBC 3part ...
If the instrument is damaged or items are missing, contact your local distributor/importer immediately for assistance. Make sure to document with photos. ! WARNING! DO NOT discard the carton box or protection material! If you need to ship the instrument (for example for service), be sure to use the original packing materials. Other forms of commercially available packing are not recommended and can void the warranty. NSTALLATION CYANHemato is an easy to operate instrument with integrated userfriendly software. No additional computers or instruments are needed. In order to fully guarantee the performance of CYANHemato, it is extremely important that it is correctly installed. CYANHemato user manual Rev. (7.0), 202111 Page 17 ...
7. Turn on the instrument 8. Verify the instrument 9. Adapt the system to the customer 3.3.1 Location specifications 3.3.1.1 EMPERATURE AND PRESSURE REQUIREMENTS Please take into account the following temperature and pressure ranges: Operate the CYANHemato within the ambient temperature range of 1830°C and relative humidity of 45%85%. The optimum operating temperature is 25°C. Avoid using the instrument in areas of extreme high or low temperatures or where it is exposed to direct sunlight. If stored at a temperature less than 10°C, the instrument should be incubated at the correct room temperature for at least an hour before use. Reagents should be stored at a temperature range of 1830°C. Place the instrument in a wellventilated location. Do not place it near potentially interfering ...
! ATTENTION POINTS! 1. The CYANHemato is a closed system. Only the CYANHemato reagents can be used for the CYANHemato and vice versa. Other reagents are not validated and may cause damage to the instrument. 2. Install the reagents in a suitable, accessible location. The best place is 0.5m 1m below the supporting desk of the instrument. The pneumatic system is capable of aspirating reagents from containers being 1m (3ft) below the reagent inputs. Note: Do NOT place the reagents above the instrument, as there can be a risk of falling and spilling 3. Make sure the reagent tubes are not bent, broken, twisted or blocked. This could result in instrument ...
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OUSE Attach the mouse cable to one of the USB A ports on the back of the instrument. o External mouse must be approved by an authorized technician. o External mouse must have a USB port or suitable adapter. 3.3.4.3 XTERNAL PRINTER Attach one end of the printer cable to the appropriate port on the printer and the other end to the CYANHemato. Attach the AC adapter to the printer (if required) and plug it into an AC outlet. o Printer must be recommended by an authorized technician. o Printer must be approved and listed. o Printer must have a CE mark. It is not possible to provide a complete list because the printer models are changing in the market, and many printers have different software or different names in different countries. Normally if a printer has a Printer Command Language (PCL)3 or PCL5 language, it should work, but we cannot guarantee it for 100%. ...
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Printers compatible with CYANHemato analyzer Software version 2.2 and older HP DeskJet 920c HP DeskJet 3520 HP OfficeJet 6000 HP LaserJet 1022 HP DeskJet 1000 HP DeskJet 5440 HP OfficeJet Pro 8000 HP LaserJet P2030 HP DeskJet 1560 HP DeskJet 5650 HP OfficeJet Pro K5300 HP DeskJet 2460 HP DeskJet 6940 HP Printers compatible with CYANHemato analyzer Software version 2.6 and higher HP DeskJet 920c HP DeskJet 3520 HP OfficeJet 6000 E609a HP LaserJet 1022 HP DeskJet 1000 HP Deskjet 5440 HP OfficeJet 6100 HP LaserJet 1320n HP DeskJet 1560 HP DeskJet 5650 HP OfficeJet 6500 e710nz HP LaserJet P1606dn HP DeskJet 2460 HP DeskJet 6940 HP OfficeJet Pro K5300 HP LaserJet P2030 HP DeskJet 3515 HP OfficeJet Pro 8000 HP Printers compatible with CYANHemato analyzer Software version 3.2 and higher HP DeskJet 920c HP DeskJet 3515 HP OfficeJet 6000 E609a ...
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Always be careful when making height adjustments in order NOT to crash the needle. Furthermore, there must be at least 8 mm sample level for safe sampling. ! ATTENTION POINTS! For microtubes with attached cap: always position the cap towards the back, against the wall of the sample holder, otherwise the cap can get stuck when the sample holder turns. Always take off the cap of the tubes! The needle cannot pierce caps. Otherwise, the needle will crash! √ 3.3.7 Connect the power supply The CYANHemato is delivered with an approved power supply and power cord. Proper use of the power cord assures adequate grounding of the system. The power outlet connection MUST be grounded. Instrument is safe for transient voltages to INSTALLATION CATEGORY II and POLLUTION DEGREE 2. Environmental and electrical characteristics provide accuracy and precision of the instrument and maintain a high level of operational safety for lab personnel. CYANHemato user manual Rev. (7.0), 202111 Page 22 ...
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4. Finally, the main menu appears (right photo). Tap the touch screen to activate the corresponding menu element. Please note that the software version number appears in the heading (2.6 in the example above). Note: Wait five minutes before initiating any measuring process to allow the instrument to reach the optimal working temperature. CYANHemato user manual Rev. (7.0), 202111 Page 23 ...
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Every 6 months (or after 10.000 measurement cycles, the following steps must be executed BY THE SERVICE ENGINEER to ensure the good performance of the analyzer: Run a selftest Check macrodilutor piston/syringe and lubricate (with motor grease and silicone grease) if necessary Check the washing head and replace if necessary Check the fluidic system and replace if necessary Disinfection of the CYANHemato (See 6.3.1) Calibration Perform quality control measurements with low, normal and high control blood (See 4.5.3) to ensure the accuracy of the instrument 3.3.10 Adapt the system to the user 1. Adjust the language if necessary (see 4.6.2) 2. Adjust the date format, and the date and time 3. Select the print setup to the customer’s needs 4. Insert the name of the hospital or laboratory where the instrument is installed (see 4.6.1) ...
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3. The analyzer will perform the necessary steps to prevent failure to the pneumatic system. The instrument will wash the diluent out of special units of the instrument in order to prevent salt accumulation there, and will fill the chamber with diluent prior to shut down in order to prevent dust condensation in the aperture. 4. The instrument will make a tone/sound indicating that it is safe to shut it off. 5. Turn off the power using the rear power switch. The « OFF » position is marked by « O » symbol. ! ATTENTION POINTS! NEVER turn off the analyzer by simply flipping the power switch on the rear panel. This could result in erroneous operations during later use. CYANHemato user manual Rev. (7.0), 202111 Page 25 ...
Date Format Exit Logout Shut down Preparing for shipment User Management Add new user Remove User Auto login set Edit / View user CYANHemato user manual Rev. (7.0), 202111 Page 26 ...
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AIN If the instrument functions correctly, the main menu of the CYANHemato user software appears automatically. Measure This menu is used to perform blank measurements as well as sample measurements. The database contains blank measurement records, calibration records and patient Database records. The storage capacity of the CYANHemato is dependent of the installed board: DIMMPC: 1 000 records DIMMBoard: 10 000 records (from software version 2.6 on) In this menu, it is possible to (re)view, print, delete and make backups of the ...
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1. Use a roller mixer and gently mix by inverting the closed sample tube at least 8 times prior to sampling to achieve a homogenous sample. Do not shake the sample, because microbubbles can form which may cause erroneous sampling/analysis! Note: Remove the cap! It is very important because the needle cannot pierce the cap! 2. Position the sample tube in the suitable sample holder on the sample rotor. 3 different interchangeable adapters for different tube types (see image below) are provided with the CYANHemato. The illustrated tubes are only examples, other types of tubes/containers can be used as long as they can be completely inserted (until the bottom) in one of the adapters. Tube adaptor 1 for primary tubes 3 5 mL Tube adaptor 2 for microtubes ...
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If the same sample needs to be measured multiple times, please mix the sample gently (Step 1) before every sampling. 4.3.2 NEW: Entering patient information The software allows the user to enter information for every sample. There are two options to enter sample information: Immediately before sample measurement In the database menu after sample analysis (see 4.4.1) To enter sample information prior to sample analysis, select the “New” button in the measure menu. The information to enter is spread over 3 tabs: Sample ID, Patient ID and options. Select the respective tab to open it and enter the information for the upcoming sample: START When all parameters are set, press the START button to use this information and start the measurement To return to the measurement screen without using/saving the information Cancel CYANHemato user manual Rev. (7.0), 202111 Page 29 ...
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Do not shake the sample, because microbubbles can form which may cause erroneous sampling/analysis! 2. Put the prediluted sample into the sample adapter 3. Press the START button. The analyzer will automatically calculate the results taking into account the 1/6 predilution factor. ! ATTENTION POINT! To calculate prediluted samples accurately, the instruments needs to be calibrated in prediluted mode as well (see 4.5.2) CYANHemato user manual Rev. (7.0), 202111 Page 30 ...
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Select a decrease (0.1, 0.2mL) in volume of the lyse reagent if the WBC histogram is shifted to the left, i.e. the different WBC populations are overlapping. This can inhibit proper separation of WBC populations. CYANHemato user manual Rev. (7.0), 202111 Page 31 ...
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By clicking the arrows to the right or left, WBC, RBC, and PLT histograms and technical information are shown. Results, histograms and other data will be stored automatically in the memory. 4.3.2.1.1 Histograms To look at the different histograms, tap the arrow on the right. First the histogram of WBC differentiation is shown, followed by the RBC histogram and finally a closeup of the PLT histogram. CYANHemato user manual Rev. (7.0), 202111 Page 32 ...
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E (Error) flag (see image below). To measure a sample whose parameters exceed the linearity, predilution is recommended (See 4.3.2). Warning cbpCH 4.3.2.1.5 Warning flags The software will display warning flags for each individual measurement to notify the user about potential problems. The following tables summarize the warning flags and gives an explanation of their possible cause as well as a few hints to overcome the problem. When enabled, these warnings flags will be printed on the printout of the results. Warning flags that refer to WBC or HGB problems are indicated with a capital letter. Warning flags that refer to RBC or PLT problems are indicated with a small letter: FLAG MEANING RECOMMENDED USER ACTION B WBC blank is high, or Repeat the blank measurement, or run prime lyse and try blank again. no WBC blank Possible lyse contamination, or noise problem. CYANHemato user manual Rev. (7.0), 202111 Page 33 ...
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PLT blank is high, or Reagent or system cleanliness problem. Run cleaning and repeat the blank no PLT blank measurement. If blank remains high, perform an emergency cleaning of the system (see 6.3.1). If the blank remains high upon reattaching the reagent, replace the diluent. Note: Never pour the remainder of old reagents in the new ones. This will contaminate the newly opened reagent. The exclamation mark flag (!) near a parameter highlights some doubt during the evaluation of that parameter. It is recommended to rerun the measurement. 4.3.3 RERUN: Run the same sample again To test the sample that was previously run again. Clicking the “Rerun” button will open the same screens as described under 4.3.2 NEW: Entering patient information. All information that was filled in when the sample was previously run will be shown. The data or options can be modified. When all parameters are set, press the START button to use this information and start the measurement. Note: CYANHemato user manual Rev. (7.0), 202111 Page 34 ...
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> 20 HGB (g/l) 010 10 25 25 250 > 250 PLT (10 9 cells/l) 0 25 25 50 50 – 1000 > 1000 If all values are within the acceptable range, all results are shown in black and no flags are displayed. √ If one or more values are outside the acceptable range, that value will be shown red and the flag corresponding to this value will be displayed next to the value. Furthermore, warning letter(s) can be displayed in the heading. These give an indication of the cause (and possible solution) for the problem (see 4.3.2.1.5). CYANHemato user manual Rev. (7.0), 202111 Page 35 ...
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This can cause a big fluctuation in the PLT values between the 3 measurements. Please contact your service engineer. d) If the probe voltages are out of range (see 0), please contact your service engineer. Note: Acceptable blank values are essential to obtain accurate and precise results. Do NOT continue measuring if one or more blank values are out of range (flags displayed). ONLY if the results of the blank measurements are within range, proceed with the following measurements (calibration, quality control and sample measurement)! CYANHemato user manual Rev. (7.0), 202111 Page 36 ...
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Press “OK” to delete the test or “Cancel” to return to the previous screen. After deletion, the options print and discard are no longer available. 4.3.7 EXIT To exit the Measure menu and return to the Main menu. After clicking the “Exit” button, some reagents will be aspirated to clean the instrument. ATABASE To access the records stored in the memory of the analyzer. You can search and review all results, print them out or delete them and it is also possible to backup the data on a USB key. All results are stored in the memory in chronological order, and can be retrieved at any time. The onboard data storage capacity is 10 000 measurements, including the complete parameter list, histograms, flags, sample data, and date/time of measurement. This only applies to instruments with a DIMMBoard (instruments with serial number starting from S/N 670086) and with software version 2.8 or higher. Instruments with a DIMMPC (with heat sink) have a storage capacity of 1000 records. In case the memory is full, the newest (actual) record will overwrite the oldest record. In order to avoid this situation, it is recommended to make a backup of the data (see 4.4.5) and then delete (all/some) stored data before the maximum storage capacity of the CYANHemato analyzer is reached. Upon entering the database menu, the first screen appearing shows the most recent saved results. Some function keys are gray (inactive). Only after selection of one or more record all function keys become blue (active). The selection can be done manually by selecting the checkbox or based on (multiple) filter/select settings (see 4.4.3). CYANHemato user manual Rev. (7.0), 202111 Page 37 ...
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results Each line starts with a checkbox and displays the Sample ID. A filled checkbox indicates that a specific record is selected for further operations. All results are shown in a table format. Use the left and right arrows to have access to the remaining, non visible parameter results and the up and down arrows are used to scroll among records. The bottom row of the screen shows the status line. This line provides information about the number of records stored in the database and the number of records selected (also those not currently in view). 4.4.1 DETAIL To visualize the detailed information as shown directly after measurement (values, histograms, technical information…). If no record is selected, pushing the detail button will show the details of the first record on the page. If multiple data are selected, the first shown data will be the one on top of the list. Left and right Use the left and right arrows to have access on the remaining screens, displaying the arrows technical and additional information and the WBC, RBC and PLT histograms. Up and down Use the up and down arrows to visualize the details of the other selected data or scroll arrows through all data if no record was selected in the table view. Print To print the details of the currently shown record. The result will be printed on the device and with the format set in the printer settings (see 4.6.1). Press “Abort” to cancel the printing. Edit To open the screen where the sample ID and patient ID information can be edited or completed. CYANHemato user manual Rev. (7.0), 202111 Page 38 ...
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Sex: Select the sex by repeatedly clicking this box: female, male or Back Press “Back” to return to the table view of the database. 4.4.2 PRINT Only after selection of one or more record(s) this button becomes blue (active). It is used to print out all the selected records. The result(s) will be printed on the device and with the format set in the printer settings (see 4.6.1). When more than 1 record is selected, you can choose between individual printing (result by result) or a table format (only when using a USB/external printer). Press “Abort” to cancel the printing request. 4.4.3 FILTER The filter menu can be used to give in search criteria to restrict the number of records or find a specific test result. Note: There is an “AND” relation between the different fields. If more than 1 field is filled in, the search can be narrowed down. Date Search by entering a start and an end date to search the records measured on a specific day or within a certain time period. Sample ID Search by entering the sample ID. Enter the complete sample ID or just a part to narrow down the search. For example, if 5 is entered, all of the data containing 5 in the sample CYANHemato user manual Rev. (7.0), 202111 Page 39 ...
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Note: This function can only be used when “All” is selected in the field “Records”. Filter To filter for all the records that correspond to your search criteria and return to the table view. The table view will only display the records that correspond to the search criteria, but it will not change the select/check status of the record. At the bottom of the screen, it will be indicated that the filter is on. Cancel Press “Cancel” to cancel your search. All of the inserted information or the different criteria will be lost. After each search, a new search can be performed by choosing “Filter” again. The different criteria can be adjusted or completed to further narrow down the filtering or selection of the records. CYANHemato user manual Rev. (7.0), 202111 Page 40 ...
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The measurements will be compared in a chronological order. This can be useful, for example, to followup the reaction of the different parameters of a specific patient to a treatment. Procedure: Select/check the records for which you want to check the variation of the parameter values. The selection can be done manually by selecting the checkbox or based on (multiple) filter/select settings (see 4.4.3). Press “Trends”. Upper box Visual representation of the variation of the blood parameters of the selected records in chronological order. On the CYANHemato, it is possible to visualize 2 parameters at a time. The color of the lines on the graph corresponds to the parameters selected in the left and right lower boxes. Below the Xaxis, the total number of measurements used for the statistics are shown. Lower boxes To select the parameter to visualize in the upper box, use the up and down arrows. The name of the selected parameter will have a certain color which corresponds to the line in the graph above. Under the name, additional information about this parameter is displayed: i. Min/Max: The minimum and maximum values of all the selected measurements ...
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i. Save: To make a backup of the selected record(s) onto an external USB memory device. The records (including histograms) are saved in a “.dat” format. This format in only readable on a CYANHemato analyzer. A progress bar shows the status of the process. By default the file name will include the serial number of the analyzer and the date of saving. The name can be changed (on a computer), but the extension “.dat” needs to be maintained for the file to remain functional. ...
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View: To review/reopen backupped record(s) (saved as “.dat” file on a USB memory device) on a CYANHemato analyzer. Use a left and right arrows to select the data you want to visualize. The selection of data can be made based on the date and time the backup was made, not by name of the file. Press “OK” to confirm your choice and open the saved record(s) or press “Cancel” to abort the operation. 4.4.6 EXIT To exit the Database menu and return to the Main menu. AINTENANCE The “Maintenance” menu contains operations concerning the maintenance and wellfunctioning of the instrument; cleaning procedures, calibration and/or specific performance analyses. Home ...
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All calibrator products come with a list of the target values for the parameters. Performing a calibration is essential for the determination of the factors for the different parameters and thus in the calculation of all sample tests results. A calibration should be performed: At installation of the analyzer. At regular time intervals (determined by the lab itself). When using a new lot of diluent. When the quality control measurements shows a systematic errors (bias) or they are outside the predefined limits. After replacing any internal component. If you want to measure samples in prediluted mode, you need to perform a prediluted calibration. CYANHemato user manual Rev. (7.0), 202111 Page 44 ...
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“Yes” to perform a calibration with a diluted control blood. The user has to prepare manually the predilution of the normal control blood using diluent reagent. Use a clean sample vial. Dilute 1/6 (1 part normal control blood + 5 parts diluent). For example: 150 µL normal control blood + 750 µL diluent. The total volume should be at least close to 1 mL Mix well by inverting the closed sample tube at least 8 times to achieve a homogenous sample. Do not shake it, because microbubbles can form which may cause erroneous sampling/analysis! Notes: The analyzer will automatically take the predilution factor into account while calculating the result. CYANHemato user manual Rev. (7.0), 202111 Page 45 ...
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5 15 HCT 0.1 0.6 PCT 0 2 ii. If a barcode reader is available “Load Datamatrix” can be used to insert the target values automatically (option for the future). iii. Press “Accept” to proceed to proceed with the calibration measurement or press “Cancel” to return to the calibration menu. 3. Perform the calibration measurement(s) by pressing START. It is strongly recommended to perform at least 3 measurements before proceeding to result. Follow the procedure for calibration measurement (See 4.5.2.2) CYANHemato user manual Rev. (7.0), 202111 Page 46 ...
ALIBRATION MEASUREMENT Calibration can only be performed by measuring normal control blood. The instrument will measure the normal control blood and because the target values are known and programmed, the analyzer can calculate the factors for different parameters. These factors will then be used for the calculations during the sample measurements. The user can change the number of measurements for calibration but it is recommended to perform at least 3 calibration measurements before accepting the results and calculating the factors. Procedure: 1. Let the normal control blood come to room temperature (18 – 30°C) for 30 minutes. Make also sure that all reagents (diluent, lyse, cleaner) are at room temperature. 2. Go to “Maintenance” “Calibration” “Measure” 3. Set the calibration measure options (prediluted and sampling depth) 4. Press “Accept” to proceed to the next step. 5. Insert the calibration target values of the normal control blood (see insert, lot dependent!). 6. Press “Accept” to proceed to the next step. CYANHemato user manual Rev. (7.0), 202111 Page 47 ...
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The CV% is an important criterion for the evaluation of the calibration measurements. It is strongly recommended to only accept the calibration if the CV% value is below the maximum limit for all parameters. Finally, the screen will also display the newly calculated user calibration factor calculated. To be able to accept the calibration, these new user factors need to within the limits (0.7 – 1.3). Accept CYANHemato user manual Rev. (7.0), 202111 Page 48 ...
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3. If the same vial needs to be measured multiple times, please mix the vial gently before every sampling. Make sure to wipe clean the inside of the cap before placing it back on the vial (and perform mixing), otherwise dried up blood (clots) can be mixed with the blood and influence the measurements. 4. Vials that are stored for an extended period of time may require extra mixing a. Hold the vial horizontally between the palms of your hands and roll the vial back and forth for 30 seconds b. Mix by rapid version to ensure the cells are suspended (Do not shake!) CYANHemato user manual Rev. (7.0), 202111 Page 49 ...
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Up to 6 different quality controls samples can be programmed on the instrument. Press “Home” to return to the main menu. Home Press “Back” to return to the previous level. Back If a barcode reader is available, the target values can be uploaded automatically Load (option for the future). Datamatrix Select one of the (programmed) quality control profiles (QC16). In the example above on the right, there are already three controls profiles present/programmed in the memory: 32800422, 32800423 and 32800424. Present data can be overwritten or a new profile can be inserted. After selection of one of the profiles, the screen below will be displayed: CYANHemato user manual Rev. (7.0), 202111 Page 50 ...
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Notes: Make sure to insert the value related to the correct control blood (low, normal or high) and with the correct unit! Some target values can only be set within the certain ranges: Parameter Low limit High limit WBC 1.0 30.0 RBC 1.00 8.00 HGB g/l 30 300 MCV 50 120 RDW CV 10 50 PLT 30 800 In case you want to omit the analysis of a certain parameter, enter 0 (zero) as a target and range for that specific parameter. Load: From software version 2.6, the target and range values can be uploaded from an “*.ini file” saved on a USB flash drive to the instrument. You only need to insert the lot number and then press the “Load” button (see 4.5.3.2). CYANHemato user manual Rev. (7.0), 202111 Page 51 ...
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The color of the lines on the graph corresponds to the parameters selected in the left and right lower boxes. Below the Xaxis, the total number of measurements performed for the selected profile are displayed. ii. Lower boxes: To select the parameter to visualize in the upper box, use the up and down arrows. The name of the selected parameter will have a certain color which corresponds to the line in the graph above. Under the name, additional information about this parameter is displayed: Ref: The programmed target and range values for this parameter. Mean: The mean value of all measurements performed for this parameter. CV: The coefficient of variation of all measurements for this parameter. SD: The standard deviation of all measurements for this parameter. iii. Print: Press “Print” to print out the trends for all the parameters separately. The graph will be printed out together with the additional information. iv. Exit: Press “Exit” to leave this menu and return to the previous menu. CYANHemato user manual Rev. (7.0), 202111 Page 52 ...
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EMATO FROM V From software version 2.6 on, the target and range values can be uploaded to the instrument as “.ini” files. Please contact your distributor to receive the «*.ini files» to perform the upload. For each lot number (xxxx) of control blood, there are 3 files: 1. Low level QC_xxxx0422.ini 2. Normal level QC_xxxx0423.ini 3. High level QC_xxxx0424.ini Procedure Save the «*.ini files» on a USB flash drive (USB < 4 GB!) Notes: Make sure all files are accessible. Save them directly on the USB disc, because the CYANHemato cannot read files that are stored inside a folder. Do NOT change the name of the file or the extension! Turn on the CYANHemato. Insert the USB flash drive in any of the 4 USB A ports. Go to « Maintenance » « Quality Control » Choose the preferred QCx to enter the control values by clicking on the button. Click on « References » to insert/upload the reference values. In the screen that appears, all control values can be inserted manually or uploaded from USB. Click on the « LOT » area (red circle) Insert the lot number correctly. This lot number is 8 digits long and is indicated in name of the file: “QC_lotnumber.ini” Then press « Load ». 10. The message “QC_xxxxxxxx.ini loaded” should appear. 11. The expiration date and target and ranges will be programmed in the software and displayed on the ...
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6. If the QC measurements remains out of range, please perform a new calibration (see 4.5.2). After recalibration, perform another QC and verify if the values are now within range. Trends The Trends menu is a statistical tool that can be used to monitor variation of the different parameters over multiple measurements. The measurements will be compared in a chronological order (Please see the explanation for Diagram 4.5.3.1). CYANHemato user manual Rev. (7.0), 202111 Page 54 ...
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Notes: 1. If the same vial needs to be measured multiple times, please mix the vial gently (Step 1) before every sampling. Make sure to wipe clean the inside of the cap before placing it back on the vial (and perform mixing), otherwise dried up blood (clots) can be mixed with the blood and influence the measurements. 2. Vials that are stored for an extended period of time may require extra mixing a. Hold the vial horizontally between the palms of your hands and roll the vial back and forth for 30 seconds b. Mix by rapid version to ensure the cells are suspended (Do not shake!) c. Gently invert the vial 8 to 10 times immediately before sampling 3. Proceed only with the sample measurement if the obtained control values are within range! If the quality controls are outside range, it is recommended to perform a calibration (see 4.5.2) 4. This procedure can only be performed by an advanced user. CYANHemato user manual Rev. (7.0), 202111 Page 55 ...
Home Press “Home” to return to the main menu. Back Press “Back” to return to the previous level. 4.5.4.1 EVICE NFORMATION To display the hardware and software setup of the instrument: model, serial number, software (SW) version, PIC version and date when compiled. Press “Back” to return to the previous menu. Note: After replacement of the main board, this screen will indicated Serial number 999999. Please check the label on the back of the analyzer to find the serial number of the CYANHemato analyzer. 4.5.4.2 ELFTEST This menu is used to verify the correct operation of essential components of the instrument individually. Upon entering the selftest menu, some function keys are gray (inactive). Only after performing a selftest (by pressing “Start”), all function keys become blue (active). The selftest should be performed: At installation. After replacing any component. After extended time out of use. ...
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This option can only be used when an external USB flash drive (USB < 4 GB!) is connected to the analyzer. Press “Save” to save the results of the performed selftest as a “.log” file on the external USB memory device. This file can visualized on a PC or send by email in case further support is necessary. Print Press “Print” to print out the results of the performed selftest. Back Press “Back” to return to the previous level. 4.5.5 Reagent status To show the current volume of reagents and the waste, as calculated by the instrument. This menu should also be used upon replacement of (one of) the reagents; to reset the calculations and to prime the tubings. The bar graphs show the reagent status. On each bar, the current volume, as calculated by the software, will be displayed in mL. With each measurement/action, the volumes are changed accordingly. When one of the reagents is running low, or the waste is full, the instrument will notify the user, and ask for a replacement. CYANHemato user manual Rev. (7.0), 202111 Page 57 ...
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Cancel: Press “Cancel” to return to the “Reagent status” menu without saving changes. Notes: The programmable ranges are: Default [mL] Minimum [mL] Maximum [mL] Diluent 20 000 1 000 25 000 Lyse 1 000 1 000 6 000 Cleaner 1 000 1 000 6 000 Waste 20 000 1 000 25 000 When the volume of the reagents or the waste is set to 0 (zero), the software will not keep track of the volumes (and not give notifications). Press “Exit” to close the “Reagent status” menu and to return to the previous menu Exit CYANHemato user manual Rev. (7.0), 202111 Page 58 ...
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3. Incubate for 1 hours. 4. Dispose of the waste container according to your laboratory’s guidelines. If there is a difference between the different regulations (MSDS, hospital, state, federal level regulations), then always follow the ‘stricter’ regulation. WARNING Risk of personal injury if waste is not neutralized before the waste container is closed. Non neutralized waste contents may produce gas, which can build up pressure in a capped container. Neutralize waste contents after removing the waste container and before capping it for disposal. CYANHemato user manual Rev. (7.0), 202111 Page 59 ...
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USB: When this option is selected, all printing will be performed by an external printer, connected to the analyzer by a USB A port. For the list of compatible printers see 3.3.3. If the printer is recognized, the screen will show the printer’s name. CYANHemato user manual Rev. (7.0), 202111 Page 60 ...
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Press “Accept” to confirm and use the programmed settings. Press “Cancel” to return to the “Printer settings” menu without saving changes. Update If you have software version 3.2 or higher and you have a printer with PCL3 or PCL5 printer list language and open source drivers, but the printer is not working due to a driver problem, please contact your distributor. CYANHemato user manual Rev. (7.0), 202111 Page 61 ...
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4.6.1.2 RINTOUTS The following items can be sent to an external printer or the builtin printer: Database (specified patient results with histograms) Database result(s) (table format) QC result (LeveyJennings chart) QC result(s) (table format) Calibration results Blank results Device information and statistics Selftest result Please find some examples of printouts below Patient report on external printer (left) or builtin thermal printer (right) Database table printout on external printer QC graphical printout on builtin thermal printer (left) or external printer (right) CYANHemato user manual Rev. (7.0), 202111 Page 62 ...
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Sound The sound of the analyzer can be enabled and disabled by clicking this function repeatedly. Language To change the language of the CYANHemato to the user’s preference. Select this box and then select the desired language in the window that opens. Export format To change the export format and thereby the amount of information that is included in the “.txtfile” (see 0). This file type can be imported into Microsoft Excel for data ...
Select from the appearing menu the profile for which you want to check or change the normal range; human, male, female, baby, toddler, or child. Parameter The selected parameter, for which the normal limits are shown below and can be changed, is displayed. Parameter order: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, PCT, MPV, PDWs, PDWc, RDWs, RDWc, LYM, MID, GRA, LYM%, MID%, GRA%, PLCC, P LCR. CYANHemato user manual Rev. (7.0), 202111 Page 65 ...
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0.90. Upon selection of this box, a numerical keyboard will appear. Insert manually the value for that respective parameters. Press Enter to confirm the value. When a sample type is more resistant to lyse, the lyse volume needs to be increased. If a sample type is more sensitive to lyse, the lyse volume need to be decreased. The need to adjust the lyse volume is best visible by checking the WBC histogram. Insert a decreased (0.1, 0.2mL) volume of the lyse reagent if the WBC histogram is shifted to the left, i.e. the different WBC populations are overlapping. This can inhibit proper separation of WBC populations. CYANHemato user manual Rev. (7.0), 202111 Page 66 ...
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Accept Press “Accept” to confirm and use the programmed settings. Cancel Press “Cancel” to return to the previous menu without saving changes. 4.6.3.4 ETTINGS This menu consists of 2 tabs where settings for the processing of the measurements and the calibration can be adjusted. Result Auto print: When enabled, the report will automatically be printed when the analysis is finished. Auto send: When enabled, the results will automatically be transmitted to the LIS system (when connected). iii. Barcode: If a barcode reader is used and this option is enabled, the scanned data is inserted as sample or Patient ID. Calibration There are 2 calibration modes available: MCV/MPV or HCT/PCT. For normal control blood provided by Cypress Diagnostics, it is recommended to use the MCV/MPV mode. Accept Press “Accept” to confirm and use the programmed settings. Cancel Press “Cancel” to return to the previous menu without saving changes. CYANHemato user manual Rev. (7.0), 202111 Page 67 ...
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Time format: Click repeatedly to change to the desired time format. There are 2 options possible: 24h mode or 12h mode. Accept Press “Accept” to confirm and use the programmed settings. Cancel Press “Cancel” to return to the previous menu without saving changes. Note: The analyzer has a builtin battery responsible for running the builtin clock when the unit is not operational. If the analyzer asks for the date and time setting after switching on the analyzer, there might be a problem with this battery. To solve the problem, contact your distributor. CYANHemato user manual Rev. (7.0), 202111 Page 68 ...
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Press “Accept” after filling in the “Login name” and “Password” to enter the main menu. Note: If the password does not correspond to the login name, an error will be shown. Cancel Press “Cancel” to return to the previous menu without log in. 4.7.2 Shutdown The instrument uses diluent, an isotonic saline solution containing salt. It is very important that the diluent is washed out of some units of the instrument in order to prevent salt accumulation. In addition, the counting chamber has to be filled with diluent prior to shut down in order to prevent dust condensation. Therefore it is necessary to always follow the instructions below when switching off the instrument. 1. In the Main menu, select “Exit” and then press “Shutdown”. 2. The analyzer will perform the necessary steps to rinse and prevent failure to the pneumatic system. 3. When everything is ready, the instrument will give a tone and a message indicating that it is safe to turn it off. CYANHemato user manual Rev. (7.0), 202111 Page 69 ...
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3. When you are finished, click OK. The instrument will drain all remaining reagents to the waste container. 4. Next, the instruments asks you to connect the cleaning tube. Attach the 3 short tubes to the 3 reagent inlet connectors at the rear panel of the instrument and submerge the free end in a bottle containing at least 100 mL of distilled water. 5. When you are finished, click OK. The instrument will aspirate the distilled water to rinse away and eliminate any residual salt to the waste container. 6. Next, the analyzer asks you to remove the cleaning tube from the 3 reagent inlet connectors on the rear plate of the analyzer. Leave the waste tube and container attached. CYANHemato user manual Rev. (7.0), 202111 Page 70 ...
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This menu enables all actions related to user management. Only the Admin (your distributor) has full access all menus. As laboratory user, you only have access to the “edit/view user” button. To add new user accounts or change the login settings, please contact your distributor. Edit/View To view or edit the user’s profile. When logged in as Admin (or Service), you can view user and edit all programmed user profiles. When logged in as a laboratory user, you can only edit your own profile. Click on the field and select the user profile you want to view or edit from the list that will appear. Press “Accept” to open the selected user profile. Press “Cancel” to return to the previous menu. CYANHemato user manual Rev. (7.0), 202111 Page 71 ...
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The advanced user type has full access to all menus (except the user management) Note: This field cannot be changed by a laboratory user. Only the admin can change this field. If change is necessary, please contact your distributor. Password: Enter a password. It must consist of 4 digits (between 0000 – 9999). The user can always change his own password after begin logged in. iii. Reenter password: Enter the password a second time. If the password is not the same as in the above field, an error will be shown. Press “Accept” to confirm and create a user profile with the programmed settings and to return to the previous menu. Press “Cancel” to return to the previous menu without saving changes. Home Press “Home” to return to the main menu. Back Press “Back” to return to the previous menu. CYANHemato user manual Rev. (7.0), 202111 Page 72 ...
DAILY ROUTINE REPARATIVE 5.1.1 Preparation of the analyzer Switch ON the CYANHemato. After a short system initialization, the login screen or the main menu will be shown. Note: If the analyzer was on for 24h, it is required to perform a cleaning. Go to Maintenance Cleaning Cleaning (3x). 5.1.1.1 HECK THE REAGENTS 1. Check the date of opening (it should be written on the reagent bottle). If the reagent has been open for >120 days, please discard the bottle and attach a new reagent bottle. Please see 4.5.5.1 for more details. 2. Check that there is sufficient reagent left to analyze all the samples of the day and to clean the instrument. There are 2 ways to check the liquid level of the reagent containers: o Visually by checking the amount of liquid in the bottle. o By using the software: Go to “Maintenance” “Reagent status” Check the level of reagents in mL. Notes: ...
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2. If the samples cannot be analyzed within a few hours after collection, samples should be stored at a temperature of 28°C immediately after sample collection. The anticoagulant requires some time (1530 minutes) to stabilize its effect and completely stop the coagulation process from starting. Blood samples should be run on CYANHemato only after this reaction time has elapsed. 4. The collected samples can be kept at room temperature (15 – 30°C) for 8 hours or can be stored in the refrigerator (2 – 8°C) for 24 hours after collection. These time periods can only be obtained when the blood samples are stored on a roller mixer 5. Before analysis, the samples need to be homogenized. a. The ideal way to homogenize samples taken out is putting them on a rollermixer for 2030 ...
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If all values are displayed in black, the QC is succeeded and you can proceed to sample measurements. b) If some (or all) QC values are out of range (displayed in red) and/or warning flags are shown, please check: That the instrument and reagents are clean by performing a blank measurement (see 4.3.4). If the control blood and reagents are at room temperature (18 – 30°C). If the target and range values have been inserted correctly; corresponding to the low, normal or high control blood used, and with the correct units! These values are lot dependent! The control blood: o Stability and storage (see insert): Expiration date? Date of opening? Temperature? o Make sure there is enough blood left to perform correct sampling o Use another vial of control blood to perform the QC 6. If the QC measurements remains out of range, please perform a new calibration (see 4.5.2). After recalibration, perform another QC and verify if the values are now within range. Notes: CYANHemato user manual Rev. (7.0), 202111 Page 75 ...
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(result by result) or a table format (only when using a USB/external printer). Press “Abort” to cancel the printing request. 4. Press “Filter” to give in search criteria to restrict the number of records or find a specific test result. 5. Press “Trends” to monitor variation of the different parameters over multiple measurements. 6. Press “Manage” to deselect, delete, or back up the selected/checked records – HUT DOWN ND OF THE DAY 1. In the Main menu, select “Exit” and then press “Shutdown”. 2. The analyzer will perform the necessary steps to rinse and prevent failure to the pneumatic system. 3. When everything is ready, the instrument will give a tone and a message indicating that it is safe to turn it off. 4. Now you can turn off the power using the rear power switch. The «OFF» position is marked by «0» symbol. CYANHemato user manual Rev. (7.0), 202111 Page 76 ...
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Notes: a. NEVER turn OFF the analyzer by simply flipping the power switch on the rear panel (without following the above procedure). Doing so may damage the instrument and result in erroneous operations during later use. b. When the instrument has to be moved or shipped or when it will be left unused for a long time (>1 week), a “prepare for shipment” procedure needs to be performed (See 4.7.3). EEKLY At the end of the week, perform the weekly maintenance: 1. Check the bottom of the washing head for saltbuilt up and if necessary wipe it off with a damp cloth 2. Check the tubing system by opening the side door and look for any liquid leakage or white salt built up on the bottom of the CYANHemato. If so, contact your local distributor. 3. Clean the outside of the instrument using a damp cloth with a soft detergent. Make sure to prevent liquids from entering the units. CYANHemato user manual Rev. (7.0), 202111 Page 77 ...
MAINTENANCE In vitro Reliable results are crucial for Diagnostics and hematology. However, reliability and accuracy of the CYANHemato can only be guaranteed if maintenance instructions are strictly followed. The procedures, listed and described below, should be followed carefully in order to guarantee the manufacturers quality specifications and the perfect working conditions of the instrument over time. Frequency What Who Daily Blank measurements (& cleaning) USER Weekly ...
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Hypoclean (CY006R04) and/or Clenz reagent (CY006R05). Also when contamination of the old reagent is suspected, please perform a full disinfection procedure before replacing the reagents 6.3.1 Disinfection / Emergency cleaning : Strictly respect the times mentioned for the different steps! Hypoclean is a very strong cleaner that can affect the tubes when it remains too long inside the instrument! 1. Start the « Prepare for shipment » procedure (Exit Preparing for shipment). 2. Instead of removing the tubes at the rear reagent inputs at the back of the instrument (as asked by the instrument, see the picture below), leave them attached to the inlets, unscrew the caps from the reagent bottles, take the tubes out of the reagents and leave them open to the air. Leave the waste connected. Wipe the outside of the tubes and the caps with clean paper dampened with disinfectant solution (CYDIS Surface, 6% ESOFENOL, 10% hypochlorite (bleach)) to disinfect them. Then wipe the caps with clean paper dampened with distilled water to ‘rinse’ them. 3. Press OK. The CYANHemato will now aspirate air to remove the liquid that remained in the tubes. 4. Next, instead of connecting distilled water using the cleaning tube kit (as asked by the instrument, see the picture below), put the 3 reagent tubes (all together) in the Hypoclean reagent (CY006R04). Do not press OK, just turn off the CYANHemato by switching of the power switch at the rear of the instrument. Turn the instrument back on. CYANHemato user manual Rev. (7.0), 202111 Page 80 ...
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Perform a prime for all 3 reagents separately (Maintenance > Reagent Status > Prime), so the Hypoclean reagent is aspirated in all 3 tubes. Run several (35) blanks, disregard the results (Measure > Blank). Leave the instrument 15 minutes untouched. (NOT longer!) 10. Start again the ‘preparing for shipment’ procedure (Exit > Preparing for shipment). 11. Instead of removing the tubes at the rear reagent inputs (as asked by the instrument), leave them attached to the inlets and just take the tubes out of the Hypoclean reagent. Wipe the outside of the tubes with some clean paper to dry them. Leave the waste connected. 12. Press OK. The CYANHemato will now aspirate air to remove the Hypoclean that remained in the tubes. 13. Next, insert the 3 tubes in a bottle with minimum 100 mL distilled water. 14. Press OK. The CYANHemato will now aspirate distilled water to rinse the tubing. 15. Next, take the 3 tubes out of the water bottle and press OK. The CYANHemato will now aspirate air. 16. When finished, the instrument asks you to turn off the system by switching off the power switch at the rear of the instrument. 17. If necessary, replace the tubes (inside the reagent container and from the reagent container to the ...
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Dirt or clogging of the needle can also influence the sampling and/or cause variation between replicate measurements. To wash the sampling needle and the related tubing using Hypoclean CC reagent (CY006R06): Procedure: 1. Fill a sample tube with 2 mL Hypoclean CC reagent and position it in the correct tube adaptor. 2. Push “Hard cleaning”. The instrument will ask you to confirm that you have prepared the Hypoclean CC solution. Press “OK” to continue. 3. Hypoclean CC will be aspirated and used to clean the sampling needle and the related tubing. 4. When the procedure is finished, remove the sample tube. CYANHemato user manual Rev. (7.0), 202111 Page 82 ...
TROUBLESHOOTING PERATIONAL Note: When there is a problem with the CYANHemato (independent of the nature of the problem), please start the diagnosis with a selftest (full) first before proceeding with further diagnosis. TROUBLE DIAGNOSING AND SOLUTION Overall result of selftest: “Failed” Please contact your service engineer. The blank measurement is out of See 4.3.4 for possible solutions for blank measurement out of range range (+,*, , Eflag) for one of the Check if: following parameters (WBC, RBC, HGB The door on the right side of the instrument is closed during and PLT) measurements The surface of the instrument is clean (no dust or dirt) Clean the surface of the instrument (see 6.2.3) The instrument is placed away from appliances that generate electrical noise or magnetic fields (e.g. radiological instruments, X ray, radio, cell phones,…) The hydraulic system (tubings, measuring chamber, dilutor block, puffer reservoir) is clean with no dust, dirt and/or strong coloration Perform a cleaning of the instrument (see 6.1) The needle for dirt and/or blockage Perform a hard cleaning of the needle (see 6.3.2) The reagents (diluent, lyse, cleaner) are contaminated, expiration date, date of opening, dirt,… ...
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Check if: The reagents (diluent, lyse, cleaner) are contaminated, expiration date, date of opening, dirt,… If necessary, perform a “disinfection” procedure (see 6.3.1) and connect the new bottle of reagents and restart the test The control blood and reagents are at room temperature (18 – 30°C). The calibration has been performed with normal control blood. The target values have been inserted correctly, with the correct units! These values are lot dependent and are included in the calibration kit. There is no problem with the normal control blood: CYANHemato user manual Rev. (7.0), 202111 Page 84 ...
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Hold the vial horizontally between the palms of your hands and roll the vial back and forth for 30 seconds b. Mix by rapid version to ensure the cells are suspended (Do not shake!) Gently invert the vial 8 to 10 times immediately before sampling Make sure to always invert the vial at least 8 times immediately before every sampling. Make sure there is enough blood left (at least 8 mm) to perform correct sampling The cover of the vial is wiped before closing the vial containing the blood to avoid dried blood from falling in Use another vial of control blood to perform the QC The needle is dirty and/or blocked Perform a hard cleaning of the needle (see 6.3.2) The probe voltages (PrVW/PrVR) are within range (260 < PrVW/R < 420) See 4.3.2.1.2 and 4.3.4 Restart the measurement and include a new calibration (see 4.5.2.2)! Make sure to perform a calibration with normal control blood CYANHemato user manual Rev. (7.0), 202111 Page 85 ...
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Use the reagents at RT (18 – 30°C) (especially the Diluent) Lyse is concentrated by evaporation Use another bottle of lyse reagent There is enough reagent left in the bottles If after theses verifications the situation still persists, please proceed with the next step. The patient sample is too sensitive to lyse. Decrease the lyse volume little by little (0.1/0.2 mL) and rerun the sample Note: Absence of 3part differential may also occur in pathological lymphocytosis. If after theses verifications the situation persists, please contact your service engineer. The WBC histogram is shifted to the Check if: right and or RBC peak is found during The reagents (diluent, lyse, cleaner) for contamination, expiration the WBC of the sample measurement date, date of opening, dirt,… That the reagents are used at a decreased temperature Use the reagents at RT (18 – 30°C) (especially the diluent) There is enough reagents in the bottle CYANHemato user manual Rev. (7.0), 202111 Page 86 ...
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If after theses verifications the situation persists, please contact your service engineer. () Eflag after running a The obtained value is beyond the programmed linearity range (too measurement high or too low) (see 4.3.2.1.4). The instrument cannot measure a result. Too low (E error + nothing visible in the histogram): This may be due to a sampling problem (see technical troubleshooting) Too high: Perform the analysis in predilution mode (see 4.3.2). When performing measurements in predilution mode, a calibration in predilution mode also needs to be performed (see 4.5.2.1). If the situation persists after the verification above, please contact your service engineer. Warning signs (small and/or capital See 4.3.2.1.5 for the description and the recommended actions for the letters e.g. “Cpb”) are obtained after obtained warning signs measurement If after all these verification the situation persists, contact you service engineer. CYANHemato user manual Rev. (7.0), 202111 Page 87 ...
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There is enough sample in the vial (at least 8 mm) During sampling the needle comes in contact with the sample There is sampling: Sample present in tubes Sample present in measuring chamber If after this verification the situation persists or if there is no sampling seen, please contact your service engineer. Printing problem on the builtin printer Please check if: There is thermal paper in the printer. The paper is oriented correctly in the builtin printer (prints only on one side) (see 3.3.4) The result print is enabled I n the printer settings (see 4.6.1 and 4.6.3.4) + setting device (see 4.6.1) If after theses verifications the situation persists, please contact your service engineer. Printing problem on the external printer Please check if: CYANHemato user manual Rev. (7.0), 202111 Page 88 ...
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The printer is compatible with the analyzer and the software of the analyzer (see 3.3.3.3) The printer is correctly connected to the analyzer. The result print is enabled in the printer settings (see 4.6.1 and 4.6.3.4) If after theses verifications the situation persists, please contact your service engineer. Screen problem Please contact your service engineer CYANHemato user manual Rev. (7.0), 202111 Page 89 ...
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Furthermore, this reagent is only validated for - Leave the reagent at room temperature for at least 12 use on the CYANHemato analyser. Please refer to the hours. instrument’s user manual for further information. REAGENT REPLACEMENT...
Furthermore, this reagent is only validated preparation is necessary. for use on the CYANHemato analyser. Please refer to - Leave the reagent at room temperature for at least the instrument’s user manual for further information.
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- This reagent is ready for use and can be applied reagents. Furthermore, this reagent is only validated for straight from the container; no special reagent use on the CYANHemato analyser. Please refer to the preparation is necessary. instrument’s user manual for further information.
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Furthermore, this reagent is only validated for preparation is necessary. use on the CYANHemato analyser. Please refer to the - Leave the reagent at room temperature for at least 12 instrument’s user manual for further information.
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Furthermore, this reagent is only validated for preparation is necessary. use on the CYANHemato analyser. Please refer to the - Leave the reagent at room temperature for at least 12 instrument’s user manual for further information.
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- Please refer to the MSDS associated with the reagent. - Use Good Laboratory Practices (GLP) when handling the reagents. Version 20160711_(5.1) Cypress Diagnostics: Nijverheidsstraat 8 • 2235 Hulshout • Belgium www.diagnostics.be • Tel: ++ 32 15 67 67 68 • e-mail: cypress@diagnostics.be...
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Big T connector (3,2 mm) Replace every 3 years CY006-S25 Small T connector (2,3 mm) Replace every 3 years Cypress Diagnostics: Nijverheidsstraat 8 • 2235 Hulshout • Belgium www.diagnostics.be • Tel: ++ 32 15 67 67 68 • e-mail: cypress@diagnostics.be...
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Transfer or replace when replacing the CY006-S59 Tube on needle head (1 cm) needle or internal hydraulic sampling tube Cypress Diagnostics: Nijverheidsstraat 8 • 2235 Hulshout • Belgium www.diagnostics.be • Tel: ++ 32 15 67 67 68 • e-mail: cypress@diagnostics.be...
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CY006 To all Healthcare Professionals, Thank you for your interest. We appreciate it! CYANHemato Cypress Diagnostics provides the tools and solutions that let clinical laboratories worldwide deliver clear and precise diagnostic results. We manufacture the equipment needed for handling the...
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CY006-C02A Control vial low/normal/high 3 x 2,5 mL URL: www.diagnostics.be CYANHemato EN 2021-09 ISO 13485-2016 ISO 13485-2016 www.diagnostics.be • Belgium • Tel: ++ 32 15 67 67 68 • e-mail: cypress@diagnostics.be www.diagnostics.be • Belgium • Tel: ++ 32 15 67 67 68 • e-mail: cypress@diagnostics.be...