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URIT Medical Electronic UC-1800 Instruction Manual

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Copyright and Declaration ........................................................................................... IV
Preface ....................................................................................................................... VI
Meaning of Markings .................................................................................................. VI
EMC ........................................................................................................................... VII
1. GENERAL INFORMATION ....................................................................................... 1
1.1 Characteristic ................................................................................................... 1
1.2 Specifications ................................................................................................ 3
1.3 Structure ....................................................................................................... 4
1.4 Measurement Principle ................................................................................. 6
2. Instrument installation .......................................................................................... 10
2.1 Inspection .................................................................................................... 10
2.2 Installation requirements ............................................................................. 11
2.3 Installation steps ......................................................................................... 12
3. FUNCTIONS ........................................................................................................... 16
3.1 Self-check ...................................................................................................... 16
3.2 Display ........................................................................................................... 16
3.3 Print ............................................................................................................... 16
3.4 Storage and review ........................................................................................ 16
3.5 Barcode recognition function (optional function) ......................................... 16
3.6 Data input and output port........................................................................... 16
3.7 Calibration function ..................................................................................... 16
3.8 Measurement items .................................................................................... 16
3.9 The report model ......................................................................................... 16
3.10 Positive (abnormal value) prompt function ................................................ 16
3.11 Automatic transmission of samples ........................................................... 16
3.14 Automatic strips feeding ............................................................................ 17
3.15 Function of emergency measurement ....................................................... 17
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  • Page 1: Table Of Contents

    Contents Copyright and Declaration ................... IV Preface ........................VI Meaning of Markings ....................VI EMC ........................... VII 1. GENERAL INFORMATION ..................1 1.1 Characteristic ....................1 1.2 Specifications ....................3 1.3 Structure ....................... 4 1.4 Measurement Principle ................. 6 2. Instrument installation ..................10 2.1 Inspection ....................
  • Page 2 Contents 3.16 Function of identifying test tube rack No. automatically ......17 3.17 Consumable status real-time monitoring ........... 17 3.18 Function of automatically enhancing the rinsing for high concentration samples ........................17 3.19 Failure alarm function................17 3.20 Mixing function ..................17 3.21 Online function (optional) ................
  • Page 3 Contents 5.1Maintenance Items ..................38 5.2 Daily Maintenance ..................39 5.3 Replace consumables ................... 40 5.4 Periodic Maintenance ..................41 5.5 Long-term Disuse Maintenance ..............45 6. TROUBLESHOOTING ..................47 6.1 Troubleshooting guide ................... 47 6.2 Technical assistance ..................47 6.3 Troubleshooting chart ..................

  • Page 4: Copyright And Declaration

    All contents in this manual were strictly compiled according to the related laws and regulations in china, as well as the specific condition of UC-1800 automatic urine analyzer, covering all the updated information before printing. URIT is fully responsible for the revision and explanation of the manual, and reserves the right to renovate the relevant contents without separate notice.
  • Page 5 URIT Medical Electronic Co., Ltd. Address :No. D-07 Information Industry District, High-Tech Zone, Guilin, Guangxi 541004, P. R. China Web:www.urit.com Email:service@uritest.com Tel:+86(773)2288586 Fax:+86(773)2288560 Shanghai International Holding Corp. GmbH (Europe) Eiffestrasse 80, 20537 Hamburg, Germany Rx Only Version : 08/2017-1，compiled in August 2017，revised in May 2021.

  • Page 6: Preface

    Preface This operation manual describes in detail the principle, structure, operation, maintenance and troubleshooting concerning UC-1800 automatic urine analyzer. User should follow the instructions presented in this manual. Meaning of Markings Followings are the markings that appear on the instrument or label.

  • Page 7: Emc

    ⚫ This Instrument complies with the emission and immunity requirements specified in IEC 61326-2-6:2020、IEC 61326-1:2020、EN IEC 61326-2-6:2021、EN IEC 61326-1:2021、IEC 60601-1-2:2014+AMD1:2020 and IEC TR 60601-4- 2:2016.See Appendix 8 for details. ⚫ The environment in which this device is intended to be used includes typical health care Settings (hospitals, clinics, doctor's offices, etc.).
  • Page 8 ⚫ Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment. ⚫ Note: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation.

  • Page 9: General Information

    All you need to do is to set test strips and samples, press the START key, and the rest of operations are fully automated with UC-1800, which can measure samples continuously. For each measurement, the instrument automatically performs a series of operation: sample transmitting, sample aspirating, sample dropping, rinsing, strip sorting, strip feeding and color identifying, etc.
  • Page 10 GENERAL INFORMATION 15. Strips discarding method: automatically collect discarded test strips. 16. Sample probe cleaning method: four-way spray cleaning can improve the cleaning effect, ensure the external and internal walls of the sample probe are clean, and there is no residual liquid on the outside of the probe, so as to avoid cross contamination between urine samples.

  • Page 11: Specifications

    GENERAL INFORMATION positive reference solution and no positive result for the negative reference solution. 39. Stability: The coefficient of variation (CV, %) of the reflectance measuring results is less than or equal to 0.9% within 8 hours after the analyzer is turned on. 40.

  • Page 12: Structure

    GENERAL INFORMATION 1.3 Structure The analyzer consists of an automatic sample injection mechanism, an automatic selection mechanism, a test strip transmission mechanism, a fluid mechanism, an optical system, a central processing unit, a waste collection mechanism, an analytical processing software, a display screen and a printer.
  • Page 13 GENERAL INFORMATION Emergency measurement tube position: it is used for emergency measurement tube placement. Emergency button: press this button for emergency measurement. Test tube rack sampling mechanism: it is used to place the test tube rack for normal measurement. The back of the instrument (Figure 1-2) Figure 1-2 Detergent A inlet interface: The detergent is delivered to the instrument through this interface.

  • Page 14: Measurement Principle

    GENERAL INFORMATION communication when online. Protective grounding interface: it is used to connect the ground wire to protect the ground. 10. Power switch: turn on or off the power of the instrument. 11. Power input port: IEC standard three-wire power plug with fuse holder. Caution Be sure to install the external interface of the instrument when the instrument is turned off, so as not to cause the instrument damage or malfunction.
  • Page 15 GENERAL INFORMATION Tm: Reflective light amount at the reactive pad with the measurement wavelength Ts: Reflective light amount at the reactive pad with the reference wavelength Cm: Reflective light amount at the calibration pad with the measurement wavelength Cs: Reflective light amount at the calibration pad with the reference wavelength 1.4.2 Specific gravity measurement principle Specific gravity measurement method is refractometer, which using the correlation between light refractive index and total solids in the solution to determine.
  • Page 16 GENERAL INFORMATION : Low concentration solution position coefficient : Sample solution position coefficient Position coefficient: It is calculated by the detector output data, and has a linear relationship with the refractive index. Refractive index change depends on the temperature of the sample solution, and the specific gravity value is using the following formula to correct.
  • Page 17 GENERAL INFORMATION Figure 1-4 Turbidity measurement principle Turbidity result is calculated by the following formula: T = (Ss / Ts - Sw / Tw) / K T: Turbidity level Ss: Sample scattered light level Ts: Sample transmission light level Sw: Flushing fluid scattered light level Tw: Flushing fluid transmission light level K: Coefficient factor 1.4.4 Color measurement principle...

  • Page 18: Instrument Installation

    2. According to the attached packing list, accept the instrument, the number and condition of the instrument； 3. If the quantity does not match or components are damaged, please contact the distribution department or the URIT MEDICAL ELECTRONIC CO., LTD. The items in the instrument package are as follows: Quantit...

  • Page 19: Installation Requirements

    Instrument installation In accessory box Serial line In accessory box Verification test strip Steel needle for In accessory box unblocking Soft needle for In accessory box unblocking In accessory box Brush for maintenance In accessory box Grease for maintenance In accessory box 3 meters ground wire SZ module Optional,in wooden package...

  • Page 20: Installation Steps

    Instrument installation Caution (1) This Instrument complies with the emission and immunity requirements specified in IEC 61326-2-6:2020、IEC 61326-1:2020、EN IEC 61326-2-6:2021 and EN IEC 61326-1:2021. (2) This Instrument is designed and tested as Class A equipment . In a domestic environment, this Instrument may cause radio interference, and protective measures shall be taken.
  • Page 21 Instrument installation Caution ⚫ The instrument must be turned off before opening the display cover and side cover. ⚫ Non-professionals or non-authorized personnel are not allowed to open the display cover and side cover at will, so as to avoid damage to personnel and instruments! knob Remove the Display cover...
  • Page 22 Instrument installation screw Figure 2-3 4. Install the detergent A, detergent B and waste liquid tubing: connect the detergent A tube to detergent A inlet connector on the instrument, and fix the other end in the bottle of URIT D21/URIT D21N; connect the detergent B tube to detergent B inlet connector on the instrument, and fix the other end in the bottle of URIT D22.
  • Page 23 Instrument installation Ethernet interface YC module Bridge ST module Figure 2-4 5. After installation, start the instrument. If the ST module and YC module need to be enabled, click [Setting] → [General] → [Measure]→ [Online] button and select “UD-1300”.

  • Page 24: Functions

    3. FUNCTIONS 3.1 Self-check The system starts with self-check and initialization when turning on the instrument power switch. If error is detected during the self-check process, relative hint or message will be displayed on the screen. 3.2 Display Menus, hints, operation information and measure results are displayed on the 10.4-inch LCD. Measuring results can be indicated with four kinds of expression: Symbol unit, International unit, Traditional unit or English description.

  • Page 25: Automatic Sample Aspiration, Automatic Dropping, Automatic Rinsing

    FUNCTIONS 3.12 Automatic sample aspiration, automatic dropping, automatic rinsing The sample probe and injection pump will automatically take samples, and automatically drop samples at the dropping position. After dropping samples, the rinsing function will be automatically carried out and the waste liquid will be discharged. 3.13 Automatic collection of discarded test strips and waste liquid The instrument automatically collects used test strips and waste liquid.

  • Page 26: Chinese And English Interfaces Switching

    FUNCTIONS 3.24 Chinese and English interfaces switching You can choose the Chinese or English display interface. 3.25 Applicable test strips URIT 11FA and URIT 12FA of URIT series. Note: The types of applicable test strip have been set by the manufacturer before leaving the factory.

  • Page 27: Function Of Displaying Strip Images

    FUNCTIONS 3.36 Function of displaying strip images The analyzer has the function of capturing, displaying and storing the images of urine test strips after sample addition, and is used for result review and inspection.

  • Page 28: Operation

    4. OPERATION 4.1 Cautions Biohazard Wear protective gloves to prevent infection. Caution Discard used gloves in accordance with local regulations. Caution Sample probe is sharp and it’s running in the process of instrument operation. Do not approach it when not operating the instrument. Please use the correct method to operate the sample probe during instrument operation to avoid injury.

  • Page 29: Preparations

    OPERATION DO NOT add any preservative, disinfectant or detergent to the samples. The urine sample should avoid direct sunlight. High concentration of ascorbic acid contained in urine sample may lead to the measuring results of NIT, BIL, GLU and BLD lower than the actual values or even false negative. DO NOT measure hematuria as residue in it may cause incorrect results.
  • Page 30 OPERATION strips in it. Caution 1. DO NOT touch the reagent pads on the strips. 2. Load the strips in correct direction. 3. Tighten the cap of strip canister to prevent strip from moisture. 4. Please do not put too many test strips at a time. Too many test strips will affect the measure speed of the instrument.
  • Page 31 OPERATION If the barcode is to be scanned by the scanner built in the instrument, the barcode should be pasted as shewn below (as shown in Figure 4-2). The first diagram is for the instrument without ST module, and the second is for the instrument equipped with ST module. Barcode face to the notches Figure 4-2 Caution...

  • Page 32: Settings

    OPERATION 2）The test tube rack sample injection mechanism has a maximum of 6 to be measured tube racks on the right platform. If the instrument is equipped with ST module and YC module, the excess to be measured tube rack can be placed on it (Up to 20 to be measured racks ). When you place the test tube rack, insert the notch on the right side of the rack into the anti-reverse tank on the right side of ST module.
  • Page 33 OPERATION 4.3.3 Measuring screen （Figure 4-5） Figure 4-5 The measure interface function is for monitoring the analysis process and displaying analytical data in real-time. The Measuring screen (shown as Figure 4-5) is composed of four sections: Top bar: The dark background on the left is the three system interface buttons of [Measure], [Data], [Setting], the right is current test strip type and amount of to be measured samples.
  • Page 34 OPERATION rack or the uncoded test tube rack is used, the number displayed by the instrument is automatically numbered from 101. ⚫ The sample data of the emergency measurement shows that there is no test tube rack number and no test tube number. The serial number starts with st and defaults from st0001. Lower button bar: There are five function buttons such as 【QC】,【Parity】,【Start】,【SG Cal】,【Shutdown】.
  • Page 35 OPERATION Caution Strip type must be set to be the same as you use before measuring. 4.[SG Cal]: This button is used for calibrating the function of color, specific gravity and turbidity modules. Before using this function, you should confirm that the SG module function status in setting interface is "On".
  • Page 36 OPERATION Data interface layout is similar to the measure interface. The main difference is the lower button bar. There are six function buttons such as [Query], [Print], [Output], [Export], [Edit], and [Delete]. 1.[Query]: You can query according to the date or barcode. After pressing this button, the system will pop up the selection window.
  • Page 37 OPERATION an increase of the detergent consumption. 4.[Sample detection]: After this function is turned on, the system will prompt the test tube rack number and test tube number that are insufficient in the sample volume. 5.[SG Module]: Turn on this function to enable the instrument to activate the urine hydrometer/turbidity meter/color module measurement function.
  • Page 38 OPERATION Click [Apply] to save the settings. [Temperature] In this interface, you can set the target temperature of the thermostat control module and whether the temperature control module is enabled. The operation method is to click the button on the right side of [Temperature control target temperature], and input the target temperature in the pop-up input box.
  • Page 39 OPERATION between negative and positive. Adjust the linearity rate is to adjust the whole linearity by the button of Increase and Decrease. The item can be adjusted from 10 to -10. Note: Each item can only adjust one of the "positive rate" or "linear rate" compensation. 0 means no adjustment.
  • Page 40 OPERATION 2.[Print]: print the current selected record, and select multiple records to print continuously at a time. 3.[Delete]: delete the selected record. 4.3.5.5 [Customize] (1) Prepare before testing according to Section 4.2. (2) Click 【Customize】 in Measure interface，and a new window pops up. Set the test information in the new window and select [OK] to start the custom test.

  • Page 41: Normal Measurement

    OPERATION Caution This function must be performed under the direction of URIT or a qualified engineer authorized by URIT. 4.3.5.8 [Debug] The interface is used to debug equipment for the manufacturer. 4.3.5.9 [About] This interface mainly displays the related information of each module of the instrument system. 4.4 Normal measurement Biohazard Wear protective gloves to prevent infection.

  • Page 42: Emergency Measurement

    OPERATION Biohazard Discard waste liquid and waste test strips in accordance with local laws and regulations. 4.5 Emergency measurement In the process of normal measurement, if emergency measurement is to be inserted, the following steps shall be followed: Inject the emergency sample into a clean test tube with a sample volume of not less than 2 mL. Put the prepared test tube into the emergency test tube.
  • Page 43 OPERATION 3、Keep the test strip clean. 4、In general, only one is used and the other is used as a backup. 5、After the instrument is checked, please compare it with the data on the bottle. If it is in compliance, the instrument can be used normally. If it does not match, please check the instrument carefully or verify that the test strip is faulty.
  • Page 44 OPERATION instrument statistics the quality control results. 4.6.2.2 SG module quality control measurement Caution In order to ensure the accuracy of the measure results, it is recommended to do QC measurement with URIT specific gravity, turbidity and color quality control materials in the following situations.
  • Page 45 OPERATION Caution 1. Please make sure that you use URIT calibration products, otherwise the calibration will fail. 2. The color calibration solution is deionized water. 3. If the calibration fails twice, please contact our after-sales service department. 4. If the instrument is not equipped with a hydrometer, turbidity meter, color module, it is not necessary to perform quality control measurement and calibration for specific gravity, turbidity and color.

  • Page 46: Maintenance

    5. Maintenance UC-1800 is a precise instrument. It’s very important to keep maintenance periodically to keep the instrument work properly. If there’s something wrong with the instrument, please send it to the maintenance department or repair it by the professionals which URIT appoints.

  • Page 47: Daily Maintenance

    Maintenance Clean test tube rack weekly injection platform Clean ST module weekly Clean YC module weekly 5.2 Daily Maintenance 5.2.1 Clean the waste box After using the instrument every day, empty the used test strips in the waste box and disinfect the waste box.

  • Page 48: Replace Consumables

    Maintenance Make sure the instrument is turned off or on standby. Remove the cap from the waste bottle. Discard the waste liquid. Step 2: Clean the waste bottle Clean the waste bottle with alcohol, and wash it with water. Step 3: Cap the waste bottle Put the cap back on the waste bottle and tighten it.

  • Page 49: Periodic Maintenance

    Maintenance Step 3: Load the new paper roll 1. Place the paper roll in the printer bin slot (Figure 5-4). 2. Place the front end of the paper roll directly at the paper exit and cover the paper compartment cover (Figure 5-5). Figure 5-4 Figure 5-5 Caution...
  • Page 50 Maintenance Side cover Fixing screws switch Side cover Strip mechanism baffle Figure 5-6 Figure 5-7 Step 3: Remove the selection mechanism baffle 1. Remove the fixing screws of the selection mechanism baffle and take out the baffle (as shown in Figure 5-7). 2.
  • Page 51 Maintenance Step 6: Install the side cover 1. Replace the side cover. 2. Close the side cover switch and lock the side cover. 5.4.2 Cleaning the selection mechanism Items required: big-size air pump, tissue paper. Step 1: Turn off the power supply Make sure the instrument is on standby, and then exit the system and power off.
  • Page 52 Maintenance Step 6: Clean the feeding components Place the test strip feeder to the right (Figure 5-8). Clean the areas with the pump (Figure 5-13). Clean the area Figure 5-13 Step 7: Install the selection mechanism and baffle Install the selection mechanism Install the baffle, and tighten the screws.

  • Page 53: Long-Term Disuse Maintenance

    Maintenance Make sure the instrument is on standby, turn off the system and turn off the power. Step 2: Empty the test tube racks on the platform Empty the test tube rack on expansion mechanism ST module and YC module. Step 3: Clean the surface of the platform Use gauze or cotton swab to clean the test tube injection mechanism, ST module and platform of YC module.
  • Page 54 Maintenance used gloves according to local regulations. Items required: detergent, cotton swabs, deionized water, alcohol, paper towels, protective gloves. Step 1: Clean the strip selection mechanism, the dropping detection platform, and the test tube rack sample injection mechanism. Refer to Section 5.4 Step 2: Discard used test strips Discard the used test strips in the waste box.

  • Page 55: Troubleshooting

    6. TROUBLESHOOTING Caution Make sure if it is necessary to turn off the power supply before troubleshooting. Troubleshooting operations are described in this chapter. If the problem persists after following the recommended remedy, contact URIT. 6.1 Troubleshooting guide Be sure to read through this operation manual and be familiar with the operation flow and maintenance.
  • Page 56 A1 operation timeout contact the after-sales service department of T-0201 A2 driving liver reset fault Guilin URIT MEDICAL ELECTRONIC CO., LTD. T-0202 Dropping sample position strips inverse No strips in dropping position. Please Take out the test strips on dripping platform and...
  • Page 57 Restart the machine. If the fault is still unsolved, T-0209 File system of A2 format failed. contact the after-sales service department of Guilin URIT MEDICAL ELECTRONIC CO., LTD.. T-020a CIS is not calibrated Please recalibrate CIS T-020b CIS calibration block not found...
  • Page 58 TROUBLESHOOTING Guilin URIT MEDICAL ELECTRONIC CO., LTD.. T-0331 Communication fault of A3 Restart the machine. If the fault is still unsolved, contact the after-sales service department of T-0332 A3 operation timeout. Guilin URIT MEDICAL ELECTRONIC CO., LTD.. Adjusting brightness failed as it's T-0341 calibrating color.
  • Page 59 TROUBLESHOOTING 401 optocoupler fault in the right outside Guilin URIT MEDICAL ELECTRONIC CO., LTD.. T-050c of A5 401 optocoupler fault in the left inner of T-050d 401 optocoupler fault in the left outside T-050e of the A5 T-050f In bridge optocoupler error...

  • Page 60: Transportation And Storage

    7. Transportation and storage 7.1 Transportation This instrument is a precision measuring instrument. The necessary protective measures should be taken in the course of transportation. Keep away from toxicant, nocuous and corrosive material. Transport condition: -20℃～55℃, RH≤95%. Atmospheric pressure: 86kPa～106kPa. 7.2 Storage Wrapped instrument should be stored in a well-ventilated room with temperature of -20℃～55℃, relative humidity ≤95%, and keep away from toxicant, nocuous and corrosive materials.

  • Page 61: Appendix 1: Exchangeable Parts

    Selection mechanism Injection mechanism Main board Control board SG module CIS module Caution If you need to change the device, please contact the after-sales service department of URIT MEDICAL ELECTRONIC CO., LTD. Our company will arrange professional services at home.

  • Page 62: Appendix 2：Turbidity/Color Recognition Cross - Reference Table

    Appendix 2：Turbidity/color recognition cross - reference table Description Clear Micro turbid Turbid Very turbid Color Description Yellow Brown Green Colorless Other...

  • Page 63: Appendix 3：Item Name Comparison Table

    Appendix 3：Item name comparison table Abbreviation Full name VitC Ascorbic acid Leukocytes Ketone Nitrite Urobilinogen Bilirubin Protein Glucose Specific gravity Blood Creatinine Microalbumin Color Color Turbidity Turbidity...

  • Page 64: Appendix 4：Unit Results Comparison Table

    Appendix 4：Unit results comparison table Measure Semi-quantitative symbol and related concentration value items Semi-quantitative ± symbol international unit(mmol/L) VitC traditional unit (mg/dL) English unit Negative Trace Small Middle Large semi-quantitative ± symbol international unit(CELL/μL) traditional unit (leu/μL) English unit Negative Trace Small Middle...
  • Page 65 international unit(μmol/L) traditional unit (mg/dL) English unit Negative Small Middle Large semi-quantitative ± symbol international 0.15 ≥3.0 unit(g/L) traditional unit (mg/dL) English unit Negative Trace Small Middle Large semi-quantitative ± symbol international ≥55 unit(mmol/L) traditional unit ≥1000 (mg/dL) English unit Negative Trace Small...
  • Page 66 international unit(mg/L) traditional unit (mg/dL)

  • Page 67: Appendix 5：Output Format Of Data

    Appendix 5：Output Format of Data 12FA Output Format NOTE: 1. The digital represent the serial port output ASCII code serial numbering. 2. A frame starts with STX (0x02) and ends with ETX (0x03); Each line within the frame ends with CR LF (0x0d 0x0a carriage return /line feed);...

  • Page 68: Appendix 6:Toxic And Hazardous Substances Or Elements

    Appendix 6:Toxic and Hazardous Substances or Elements Toxic and Hazardous Substances or Elements Polybromi Parts Polybrominated Plumbum Mercury Cadmium Chromium nated Diphenyl (Pb) (Hg) (Cd) VI(Cr(VI)) Biphenyls Ethers(PBDE) (PBB) Shell ○ ○ ○ ○ ○ ○ Printed circuit ○ ○ ○...

  • Page 69: Appendix 7:Specificity/Interference Study

    Appendix 7:Specificity/Interference Study Substances causing false negative results Substances causing false positive Test item and concentrations results and concentrations Sodium thiosulfate(15mg/dL), Cysteine(15mg/dL),Sodium phosphate(375mg/dL),Levodopa Ascorbic acid （10.8mg/dL）, Acetylcysteine （15mg/dL）, Ammonium chloride （2500mg/dL） Urobilinogen(25mg/dL),Sodium Ascorbic acid(33.3mg/dL), Bicarbonate(1125mg/dL),Methylamine + Nitrite Bilirubin(60mg/dL),Creatinine methylene blue （1125mg/dL）...
  • Page 70 Quaternary Ammonium(100mg/dL), Sodium Amoxicillin（1050mg/dL）, Ibuprofen Bicarbonate(1125mg/dL),Gabapentin （125mg/dL）, Ammonium chloride （15mg/dL） Methylamine + methylene Protein （1250mg/dL） Calcium chloride blue（100mg/dL+17.5mg/dL）, Bilirubin （225mg/dL） （40mg/dL）, Creatinine（750mg/dL）, HGB（2500mg/dL）, Urea （15025mg/dL） Sodium Bicarbonate(750mg/dL), Peroxidase(10mg/dL),Glycine(225mg/d L),Biotin（3750mg/dL）, Methyldopa Ascorbic acid（33.3mg/dL）, Furosemide Blood （33mg/dL）, Methylamine + methylene （100mg/dL）, Ibuprofen（250mg/dL）, blue（100mg/dL+17.5mg/dL）...

  • Page 71: Appendix 8:Emission And Immunity Test Case And Requirement

    Appendix 8:Emission and Immunity test case and requirement Table 8-1 Emission test case and requirement Performance Test case Basic standard criterion Conducted CISPR emission 11:2015+A1:2016+A2:2019 Group 1,Class A equipment CISPR Radiation emission 11:2015+A1:2016+A2:2019 Table 8-2 Immunity test case and requirement Performance Test case Basic standard...
  • Page 72 25/30 cycles 70% IEC 60601-1- Voltage 0%,Duration:250/300 2:2014+AMD1:2020 interruptions cycles IEC61000-4-11：2020 IEC 60601-1- 2:2014+AMD1:2020 burst 1kV，100kHz IEC61000-4-4：2012 IEC 60601-1- 2:2014+AMD1:2020 Line to Ground：1kV Surge IEC61000-4-5： Line to line：0.5kV 2014+A1：2017 IEC 60601-1- 3V,0.15-80MHz 2:2014+AMD1:2020 Conducted RF 80%AM with 1kHz IEC61000-4-3：2013...

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