Konsung PRO Compass2800 Series User Manual

Portable dry biochemical analyzer

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PRO
Konsung
Compass2800 Series
Portable Dry Biochemical Analyzer
User Manual
Read this manual carefully before use the product!
Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd.

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Summary of Contents for Konsung PRO Compass2800 Series

  • Page 1 Konsung Compass2800 Series Portable Dry Biochemical Analyzer User Manual Read this manual carefully before use the product! Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd.
  • Page 2 Register your device To activate your warranty, follow this simple process to register your device. You have two options: Using a mobile device with internet access: 1. Using your phone camera, scan the right-hand QR code on the device's reverse 2.
  • Page 3 User’s operation failing to comply with this manual may result in malfunction or accident for which Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd. (hereinafter called Konsung”) cannot be held liable.
  • Page 4: Important Statement

    Important Statement  This analyzer can only be used with the matched test strip supplied by Konsung. Using the others test strip may cause inaccurate measurements.  The analyzer is intended for in vitro diagnostic use only, it is indicated for use in clinical laboratories and for point‐of‐care settings.
  • Page 5 Konsung Responsibility of the Manufacturer Konsung holds the rights to modify, update, and ultimately explain this manual. Konsung is responsible for the effects on safety, reliability and performance of this product, only if:  All installation operations, expansions, changes, modifications and repairs of this product are conducted by Konsung authorized personnel;...
  • Page 6: Table Of Contents

    Konsung Table of Contents 1 Product Information ..........1 1.1 Introduction ............1 1.2 Contraindications ..........1 1.3 Components ............2 1.3.1 Front View ............2 1.3.2 Top View ............3 1.3.3 Back View .............4 1.3.4 Test strip and dial card .........4 1.4 Safety Information ..........7 1.5 Symbol and Explanation ........
  • Page 7 Konsung 3.7.2 Set Units .............30 3.7.3 Set Sample Type .........31 3.7.4 Clear Record ..........32 3.7.5 Backlight setting ........34 3.7.6 Connect Bluetooth printer ......35 4 Care and Cleaning ..........38 4.1 Cleaning the analyzer ........38 4.2 Cleaning the test strip slot ........ 39 4.3 Disinfection ............
  • Page 8: Product Information

    AD value. Intended Use Use matched test strip that manufactured by Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd. to quantitatively analyze clinical chemical components in human whole blood, serum and plasma with the reflection spectrophotometry.
  • Page 9: Components

    Konsung 1.3 Components 1.3.1 Front View Indicator Display screen DOWN button UP button POWER/ MEASURE button Test strip slot Indicator:  The indicator lights red if the analyzer connected to the AC power supply, it indicates that the battery is being charged.
  • Page 10: Top View

    Konsung UP/DOWN button:  After turning on the analyzer, press and hold button ▲ or ▼ to switch the menu screen;  In the history screen, press button ▲ or ▼ to turn the page to view the history;  In the setting screen, press button ▲ or ▼ to select the setting item;...
  • Page 11: Back View

    Konsung 1.3.3 Back View Dial card port Insert dial card here Battery cover Battery cover buckle 1.3.4 Test strip and dial card Test strip Dial card Blood application hole Front Rear NOTE: Each analyzer is equipped with a QC dial card, and the same batch of test strips are equipped with a dial card of the same color.
  • Page 12 Konsung 1.3.5 Display Screen Measure Screen...
  • Page 13 Konsung History Screen...
  • Page 14: Safety Information

    Konsung Settings Screen 1.4 Safety Information WARNING  Before using the analyzer, you need access to professional medical knowledge.  Follow the instructions to use the equipment, any improper operation may lead to inaccurate measurements.  Wear protective gloves to avoid bacterial infection during...
  • Page 15  Do not place the analyzer in location that is easy to fall, falling and crashing may cause the malfunction of analyzer.  To ensure user safety, use only parts and accessories specified by Konsung or in this manual.  Do not use the analyzer if it is not working properly or damaged.
  • Page 16: Symbol And Explanation

    Konsung  Do not place the analyzer or its data cable on the object surface with higher temperature.  Do not place anything on the top of the analyzer. NOTE:  The pictures and interfaces in this manual are for reference only.
  • Page 17 Konsung Non-ionizing Power ON/OFF electromagnetic radiation Name and Address of UK UKCA mark responsible person The symbol CE mark indicates that the device should be sent to the special agencies according Authorized representative to local regulations in the European for separate...
  • Page 18: Installation

    Konsung 2 Installation 2.1 Getting Started Before unpacking, examine the packing case carefully for signs of damage. If any damage is detected, contact the carrier. If the packing case is intact, open the packing case in a right way, take out the analyzer and its accessories from the packing case, and check according to the Packing List.
  • Page 19: Environmental Requirements

    Konsung 2.2 Environmental Requirements The operating environment of the analyzer must meet the requirements A.3 Environmental Specifications specified in this manual. Do not use the analyzer in places where are wet, containing corrosive gases, with strong dust, strong electromagnetic interference to ensure the normal use of it.
  • Page 20: Connect The Power Supply

    Indicates that the battery is low. Please charge it in  time. NOTE: Do not charge the battery separately with other charger.  Charge the battery with power adapter supplied or specified  by Konsung.
  • Page 21 Installing and replacing battery Be sure to replace the battery with the same model and specification specified by Konsung. When the battery is replaced, the test results, time and date saved in the history record will not be deleted.
  • Page 22: Operation Of Analyzer

    Konsung 3 Operation of Analyzer The analyzer is calibrated at the factory and the user does not need to calibrate. The analyzer is intended for use only by clinical professionals or under their guidance. It must only be used by persons who have received adequate training in its use.
  • Page 23: Powering Off

    Konsung NOTE: If you do not click the "+", the calibration prompt will pop up after a period of time. At this time, the touch screen is inoperable, you need to turn off the analyzer and restart it, and then click the "+" to complete the touch screen calibration.
  • Page 24 Konsung When to perform QC test The first use of the analyzer;  Every day before starting measurement;  The test data is obviously abnormal.  QC test procedure A QC strip and QC dial card is provided by our company, refer to its instructions for use for details.
  • Page 25: Testing

    Konsung 5. Insert the QC strip into slot. 6. Wait for completing test, and the analyzer prompts "QC test Passed". 7. Click “Stop” to finish the quality control testing. External quality control test Refer to the instructions for use of quality control materials purchased from third parties for details on specific tests.
  • Page 26 Konsung The following are required for blood test.  Portable Dry Biochemical Analyzer  Test strip  code card with same batch number  Lancet (collecting capillary specimen)  Capillary tube or pipette  Sterile gauze or cotton ball or cotton swab* ...
  • Page 27 Konsung NOTE: You can also set the sample type in Setting screen. Before testing, confirm whether the sample type is correct, otherwise it will affect the accuracy of measurements. 5. Select the appropriate type based on the testing sample, the analyzer prompts “Insert Dial Card”.
  • Page 28 Konsung 7. The analyzer shows the LOT number, and prompts “Press Power to start”. 8. Press button , the analyzer shows “Insert Strip”. 9. Insert the new test strip with front side (the side with sample application hole) facing up into the slot.
  • Page 29 Konsung 10. Refer to the instructions on the sample volume and sample collection in the instructions for use of each test strip, and drop the collected blood sample into the sample application hole. 11. The screen displays the countdown to the test. After the...
  • Page 30 Konsung be infectious. Consult local environmental authorities for proper disposal. Do not use the analyzer in direct sunlight place, the  measurement accuracy will be affected. Do not insert others except for the matched test strip into  the slot.
  • Page 31: Measuring Capillary Blood

    Konsung 3.4.1 Measuring capillary blood 1. Make sure the patient’s hand is warm and relaxed. Use only the middle or ring finger for sampling. Avoid fingers with rings on. 2. Clean fingertip with disinfectant or cotton swab dipped in alcohol. and allow drying completely or wiping off with a dry lint-free wipe.
  • Page 32 Konsung 5. And lightly press the finger from the top of the knuckle towards the tip. 6. Hold the middle of the collection tube to collect sufficient amount of blood. When the blood rises to the black line marked on the tube, the blood collection is completed.
  • Page 33: Venous Blood Specimen Testing

    Konsung 3.4.2 Venous blood specimen testing 1. If the blood sample stored in the refrigerator, it should be preceded and heated to room temperature (15-35°C, 59-95°F) before measuring. Using a mechanical stirrer to stir the sample at least 1-2 minutes or using hand to upside down 10-20 times of the sample tube to make the venous blood samples was thoroughly mixed.
  • Page 34: Review History Record

    Konsung 3.5 Review History Record The test result is automatically saved in the analyzer. Press and hold button ▲ or ▼ to select “History”; or touch the screen with your fingertip, click “History” to enter the history interface. Click “Print” to print the history result in current page via the connected external printer.
  • Page 35: Upload Measurements

    Konsung 2. Click “Yes” or to confirm the number and the result is displayed on the screen. 3.6 Upload Measurements The analyzer can upload the measurements to the desired device. USB data cable can be used to upload the measurements to PC, the upload function needs software support, please contact our service personnel for details.
  • Page 36 Konsung 2. Press button or click “Time” on screen to enter the time setting. * becomes >. The year digit will be flashing as shown in below figure.
  • Page 37: Set Units

    Konsung 3. Press ▲ or ▼ to adjust value, then press button confirm the setting, the next digit is flashing. 4. Adjust the values of year, month, day, hour, minute, and second in turn. Press button to confirm the setting...
  • Page 38: Set Sample Type

    Konsung 3. Press button ▲ or ▼ to select unit, or click the checkbox to switch unit between “mmol/L” and “mg/dL”. 3.7.3 Set Sample Type 1. In Setting screen, press ▲ or ▼ to move cursor to select “Sample Type”, * is displayed before Sample Type.
  • Page 39: Clear Record

    Konsung 2. Press button to enter setting, * changes to >. 3. Press button ▲ or ▼ to select type, or click the checkbox before sample type. 4. Press button to save setting, the symbol > before the sample type changes to *.
  • Page 40 Konsung 2. Press button to enter clear record setting, * becomes >.
  • Page 41: Backlight Setting

    Konsung 3. Press button ▲ or ▼ to select “Yes” or “No”. Or click the checkbox before “Yes” or “No”. “Yes” means to clear all data stored in analyzer. “No” means to cancel the clear record operation. to save setting, > becomes *.
  • Page 42: Connect Bluetooth Printer

    Konsung 3. Press button▲ or ▼ to adjust backlight. Or click the brightness bar to adjust the backlight. 4. Press button to save setting, > becomes *. 3.7.6 Connect Bluetooth printer If the analyzer is already connected to Bluetooth printer, the status of the Bluetooth printer will be displayed as "Connect"...
  • Page 43 Konsung If "Disconnect" is displayed, click "Disconnect" to enter the printer search screen. The analyzer scans available printers automatically.
  • Page 44 Konsung Select one printer and click "Connect". After the printer is successfully connected, the “Connect” changes to "Disconnect". "Last” : click this key to view last page.  “Next”: click this key to view the next page.  “Return”: click this key to return to the setting screen.
  • Page 45: Care And Cleaning

    Konsung 4 Care and Cleaning Use only the substances approved by us and methods listed in this chapter to clean or disinfect your equipment. Warranty does not cover damage caused by unapproved substances or methods. We make no claims regarding the efficacy of the listed chemicals or methods as a means for controlling infection.
  • Page 46: Cleaning The Test Strip Slot

    Konsung 4.2 Cleaning the test strip slot 1. Wipe and clean the test strip slot by soft cotton swab with neutral cleaning solution. (Note: Alcohol cannot be used for transparent parts, only clean water can be used.) 2. Dry the analyzer in a ventilated, cool place after cleaning.
  • Page 47: Disposal Of Waste

    Konsung 4.4 Disposal of waste Discard used blood samples, test strips and protective gloves in accordance with local regulations on disposal of bio-hazard waste. The analyzer should be disposed in accordance with local standards for the disposal of electronic waste when After the...
  • Page 48: Warranty And Service

    If any questions in equipment operation, please contact the manufacturer or local agency. Jiangsu Konsung Bio‐Medical Science And Technology Co., Ltd. Address: NO.8, Shengchang West Road, Danyang Development Zone, Jiangsu Province, 212300, P.R.China Tel: 0086 -511 -86378666 Fax: 0086 -511 -86381308 E-Mail:info@konsung.com...
  • Page 49: Accessories And Spare Parts

    Konsung 6 Accessories and Spare Parts NOTE:  Use only the data cable and power adapter supplied or specified by Konsung.  Disposable accessories should not be resterilized and reused. The following accessories and spare parts are available: Accessory name/Model...
  • Page 50: Troubleshooting

    Konsung 7 Troubleshooting 7.1 Error code and prompt The analyzer will identify some troubles during operation, and the fault code and prompt will be displayed on the screen. Follow the below description to solve the troubles. Fault code and prompt...
  • Page 51: Other Troubles

    Konsung Take another new dial card and test strip Err:27 Lot expired for testing, or check if the time displayed on analyzer is correct. Perform new test. Contact the Err:28 Test abnormal manufacturer if the fault still exits. 7.2 Other Troubles Some common troubles will occur during the operation of analyzer.
  • Page 52 Konsung inserting the blocked by foreign the slot, restart the analyzer and test strip. matter. perform the test. Contact our service personnel if the trouble still exists. Analyzer motor is Replace a new analyzer broken Battery capacity is Connect to the AC power supply...
  • Page 53: Electromagnetic Compatibility

    Konsung 8 Electromagnetic Compatibility 1. The equipment complies with electromagnetic compatibility requirements specified in IEC 61326-1:2005 and IEC 61326-2-6:2005. 2. The manufacturer should provide EMC information to the customer or user. The user should ensure that the equipment is in an electromagnetic compatibility environment and that the equipment is functioning properly.
  • Page 54 Konsung Table 2 Electromagnetic immunity Fundamental Immunity test Test value Compliance standards Electrostatic IEC/EN Contact: ±2kV, ±4kV discharge (ESD) 61000-4-2 Air:±2kV, ±4kV, ±8kV IEC/EN 3V/m, 80MHz~2.0GHz, Electromagnetic 61000-4-3 80%AM field Electrical fast IEC/EN Power supply transient/burst 61000-4-4 cord:±1kV(5/50ns,5kHz) IEC/EN line to ground:±2kV...
  • Page 55: A Product Specifications

    Konsung A Product Specifications This chapter lists the specifications related to the analyzer main unit only. For the detailed specifications of the test strip, refer to the instructions for use of test strip. A.1 Analyzer type Electric shock protection Class II equipment and internal...
  • Page 56: Technical Specifications

    Konsung A.4 Technical Specifications Detection method Reflection spectrophotometry Sample type Serum, plasma, whole blood Test time ≤3min Accuracy or ≤±10% comparability Data storage 10000 records Display screen 3.5 inch touch screen Power supply Adapter: input voltage:100V-240V 50/60Hz, 20VA; output voltage:5V Internal power supply (Lithium battery): 3.7±0.3V...
  • Page 57: B Symbols And Abbreviation

    Konsung B Symbols and Abbreviation B.1 Units Abb. Full name µl (µL) microliter ampere °C centigrade volt watt millimeter kilopascal hour hertz liter B.2 Symbols Symbol Description negative - percent % per; divide; or ~ positive + ≤ less than or equal to ≥...
  • Page 58: Terms

    Konsung B.3 Terms Abb. Full name Alternating current Coefficient of Variation Direct current Glucose HDL-C High-density lipoprotein Cholesterol TEMP Temperature Universal serial bus International Electrotechnical Commission IEEE Institute of Electrical and Electronic Engineers LDL-C Low-density lipoprotein Cholesterol Total Cholesterol Triglycerides...
  • Page 59 Konsung Jiangsu Konsung Bio‐Medical Science And Technology Co., Ltd. NO.8, Shengchang West Road, Danyang Development Zone, Jiangsu Province, 212300, P.R.China Tel: +86-511-86375968 Fax: +86-511-86371668 E-mail: info@konsung.com Website: www.konsung.com SUNGO Certification Company Limited 3rd floor, 70 Gracechurch Street, London. EC3V 0HR Shanghai International Holding Corp.GmbH(Europe)

This manual is also suitable for:

Pro compass2800-1Pro compass2800-2

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