HB-202 Hb Hemoglobin Testing System Owner’s Booklet Realiable Hemoglobin Testing System
Contents Introduction ························································ Important Safety information ······································· Important Health-Relate information ······························· Getting to know your system ·································· Meter (battery included) ·········································· Meter Display ····················································· Test Strips ························································ Lancing Device ·············
Introduction 1 Thank you for choosing Sejoy HB-202 Hemoglobin Testing System. Before you start testing, carefully read this Owner’s Booklet. Intended Use The Sejoy HB-202 hemoglobin Meters are used with the Sejoy HS-101 Test Strips to quantitative measuring hemoglobin content with fresh capillary wholeblood from the finger or venous blood. The hemoglobin Meters can be used for self-testing at home or for professional use.The product is for in vitro diagnostic use only.
2 Introduction Important Safety information Warning • Venous whole samples collection and preparation should be obtained by healthcare professionals. • During normal testing, any Hb Hemoglobin Meter or lancing device may come in contact with blood. All parts of the kit are considered biohazardous and can potentially transmit infectious diseases from blood borne pathogens, even after you have performed cleaning and disinfecting. • The meter and lancing device should never be used by more than one person.
Introduction 3 Important Health-Related information ·Run a control test when you open a new box of test strips or if you think that your test result is incorrect. Running a Optical check mode you know that the meter is working properly. • DO NOT CHANGE YOUR TREATMENT BASED ON A SINGLE RESULT THAT DOES NOT MATCH HOW YOU FEEL OR IF YOU BELIEVE THAT YOUR TEST RESULT COULD BE INCORRECT.
4 Getting to know your system INCLUDED WITH YOUR KIT a. Hb Meter b. AAA Batteries c. Lancing Device d. Quality control Strips e. Code Chip f. Carrying Case g. Usb data cable h. test Strips I . Sterile Lancet I a b c d h f e Manufacturer of Lancing Device and Sterile Lancet Shandong Lianfa Medical Plastic Products Co., Ltd.No.1 Shuangshan Sanjian Road, 250200, Zhangqiu City, Jinan, Shandong, PEOPLE’S REPUBLIC OF CHINA EC REP Shanghai International Holding Corp.
Getting to know your system 5 Hb Meter: Reads the test strips and displays the hemoglobin (Hb) concentration and calculated hematocrit (Hct) value. Test Strips: Part of the system and used with the meter to measure Hb concentration and calculated Hct in blood. Code Chip: Automatically calibrates the meter with the code number when inserted into the meter. AAA Batteries: Provides power for the meter. Carrying Case: Provides portability for testing.
6 Getting to know your system a. Meter Type C Left Arrow Button Right Arrow Button On/Off Button LCD Strip Channel Test strip Holder Battery Cover Code Chip WARNING: Keep the meter and testing supplies away from young children. Small items such as the battery cover, batteries and test strips,are choking hazards.
Getting to know your system 7 b. Meter Display Date and Time Low Battery Reminder Bluetooth Icon Backlight Icon Out of optimal operating temperature (10℃~40℃) indicator Measurement Units Sound Icon ID Number Test Strip Reminder Apply Blood Sample Reminder Code Number or Test Result Memory Code HCT Value Sound Icon: Appears when the sound is turned on. Low Battery Reminder: Appears when the battery should be replaced. Code Number or Test Result: Indicates code number or test result.
8 Getting to know your system c. Test Strips Specimen Application Area - After strip is inser ted into the Strip Channel, apply a blood drop to the center of test strip. The Specimen Application Area is visible from the front and the back of the Test Strip. Insert Arrows - Located on the front of the test strip, the arrows show the direction in which the test strip should be inser ted. Important: the meter should only be used with HS-101 test strips.
Getting to know your system 9 Code Number Each package of test strips is printed with a code number , lot number and expiration date . Whenever a new vial is opened, mark the date on the label. Calculate the expiration date by adding three months. Record this expiration date on the label. Important test strip information for use • The system has operating range of 10℃~ 40℃（50℉~105℉）. For the most accurate results, try to test as close to room temperature 15℃ ~ 30℃ (59 ℉ ~ 86℉)as you can.
10 Getting to know your system • After removing a test strip from the vial, immediately close the vial cap tightly. • With clean, dry hands, you may touch the test strip anywhere when removing it from the vial or inserting it into the meter. • Do not use test strips beyond the expiration date. This may cause inaccurate results. • Do not bend, cut, or alter test strips. • Write the first open date and expiration date on the vial label when you first open it. Discard the vial 3 months after first open date.
Getting to know your system c. Lancing Device Adjustable Tip Arrow Protective Cover Lancing Device Cover Trigger Button Sliding Barrel Lancet Carrier Lancet Ejector d.
11 12 Setting up your meter a.Initial Setup The meter will turn on automatically after the batteries are inserted. The meter will display the full screen. Please follow below procedures to set the parameters of the meter. b.Meter Setup When use the meter not for the first time and need to set up the meter, with the meter turned off, press and hold for 2 seconds to enter Meter Setup mode shown below.
Setting up your meter 13 12 ① Set the year The year will appear at the top of the display. Press ◄ or►► until the correct year is displayed. Press button to save and the Month and Date figure is flashing automatically. ② Set the month The month and date will appear at the top of the display separated by a single dash (-), with flashing month. Press◄ or ►until the correct month is displayed. Press button to save and the Date figure is flashing automatically.
14 12 Setting Settingupupyour yourmeter meter ⑤ Set the time The hour and minutes will appear at the top of the display separated by a colon, with flashing hour. Press ◄ or ► until the correct hour is displayed. Press to save and proceed to HOUR. Note: The meter will display AM or PM if the 12H time setting is chosen. Minutes will flash. Press ◄or► until the correct minutes are displayed. Press to save and proceed to Minutes.
Setting Settingupupyour yourmeter meter OR 15 12 ⑧ Set the Bluelight Press◄or► to select Bluelight either ON or OFF. The Bluelight Symbol will appear on the display . Press to save and proceed to Bluelight setup. ⑨ Set the Backlight OR Press◄or► to select backlight either ON or OFF. The backlight Symbol will appear. Press to save and proceed to Backlight setup.
16 12 Setting Settingupupyour yourmeter meter c.Optical check with the meter turned off, press and hold for 2 seconds to enter Meter Setup mode. Press ◄ or ► until PC is display.Press to enter optical check mode,insert the quality control strips,and then press to start the optical system inspection. If “YES”is displayed, the Meter is normal;If “NO”is displayed,the Meter is abnormal. Note:if the optical system is abnormal,please check the quality control strips for contamination,bending or damage.
Setting up your meter 15 17 Coding your meter CODE 005 LOT ： Expiration date ： ① Check the code on the test strip vial before inserting the test strip Code numbers are used to calibrate your meter with the test strips you are using Frist open date ： ② Put the code chip from strip package into the chip port of meter. Each strip package contains one chip code.
18 12 Setting up your meter CODE 005 LOT ： Expiration date ： Frist open date ： 005 (Example) ④ Match the code on the meter with the code on the test strip vial •If the code on the meter match the code on the test strip vial, the meter is now ready to perform a hemoglobin test. • If the code on the meter does not match the code on the test strip vial, please discard this vial test strips and contact vendors.
Computer connection 15 19 Computer requirements The Hemoglobin Meter requires a Computer device with: Compatible with win7,win8,win10 operating systems. Installed with WPS (2016 or later) or Microsoft office(2010 or later). And works with: Desktop or laptop. Using for the first time 1. Download the "HB data software" software and Meter Drive from Website. 2.Open the software on your Desktop or laptop. Connect computer and Meter with matching data cable, Installation of meter driver. 3.
20 Testing Preparing the lancing device Warning • During normal testing, any Hb Hemoglobin meter or lancing device may come in contact with blood. All parts of the kit are considered biohazardous and can potentially transmit infectious diseases from bloodborne pathogens, even after you have performed cleaning and disinfecting. • The meter and lancing device should never be used by more than one person.
Testing 21 Preparing the lancing device ① Twist off the lancing device cover. ② Insert a new lancet into the lancet carrier firmly. ③ Hold the lancet needle cover and gently twist it until it separates from the lancet. ④ Replace the lancing device cap. Avoid touching the lancet pin. ⑤ Adjust the depth setting The adjustable tip offers 5 levels of skin penetration. Twist the lancing device cap until the desired setting appears. Note: A shallower puncture may be less painful.
22 Testing Preparing the lancing device ⑥ Cock the lancing device Slide the ejection spring controller back until it clicks. The lancing device isready to use. If it does not click, that’s okay. It may have been cocked when you inserted the lancet.
Testing 235 Fingertip Blood Sampling ① Prior to testing, make sure the hand is warm and relaxed before collecting the capillary blood specimen. Use warm water to increase blood flow if necessary. Massage the hand from the wrist up to the fingertip a few times to encourage blood flow. Clean the testing site with an alcohol swab and then dry the testing site thoroughly. ② Place the lancing device firmly against the side of your fingertip. Press the Release Button.
24 Testing Fingertip Blood Sampling ④ For use with the Capillary Transfer Tube, hold the tube horizontally and touch the tip of the Capillary Transfer Tube to the blood sample. Capillary action will automatically draw the sample to the fill line and stop. Note: The Capillary Transfer Tube will fill automatically. Never squeeze the Capillary Transfer Tube while sampling.
Testing 25 Disposal of the Lancet Unscrew the lancing device cover. Place the safety tab of the lancet on a hard surface and carefully insert the lancet needle into the safety tab. Press the release button to make sure that the lancet is in the extended position. Slide the ejection button forward to eject the used lancet. Place the lancing device cover back on the lancing device.
26 Testing Venous Blood Sampling For fresh whole blood venous specimens, collect the venous blood in a closed container with EDTA or heparin sodium anticoagulants. Mix the specimen well, then collect approximately 10 µL into a plastic syringe or pipette. Apply it to the center of the Specimen Application Area of the strip. Do not to touch the strip with the pipette. Whole Blood must be tested within 8 hours of collection.
Testing 27 Blood Sampling IMPORTANT: • Use only Test Strips HS-101. • Make sure your meter and test strips are about the same temperature before you test. • Testing must be done within the operating temperature range 10℃～40℃（41℉～104℉). For the most accurate results, try to test as close to room temperature 15℃ ~ 30℃ (59 ℉ ~ 86 ℉)as you can. • Tightly close the cap on the vial immediately after use to avoid contamination and damage. • Store unused test strips only in their original vial.
28 Testing Testing ① Turn the meter on. The screen will briefly display all of the LCD symbols. Observe the LCD at startup to ensure all segments and display elements are turned on, and there are no missing icons or elements. Note: If appears, it indicates the battery is almost out of power. Replace the battery now. No. ② After startup, the Initial Screen will be displayed.
Testing 29 Testing ⑤ Apply approximately 10 µL of blood to the middle of the Specimen Application Area of the test strip. Note: For testing capillary blood, use the second drop of blood for accurate results. Refer to Section 6 Fingertip Testing for details. ⑥ The meter will begin testing automatically with three dashes in a line flashing on the display indicating the test is in progress. No. ⑦ Hb results will be displayed within 15 seconds, with Hct value displayed at the bottom of the screen. No.
30 Data and memory Deleting Data To delete all data from the meter database, enter the Setup Menu (refer to Section 4 Meter Setup). Press◄ or ► until dEL is displayed. Press to delete all data. After flashing, all data will be cleared and dEL will be displayed again. Uploading Data In standby mode, connect the computer with the USB cable. To upload all data from the meter database,enter the Setup Menu.Press ◄or► until PC is displayed.Press to upload all data.
Maintenance 31 Replacing the battery ” appears on every display If your battery runs low, the battery symbol “ screen until you change the battery. An E-4 error message will appear if the battery is too low to perform any more tests. The meter will not function until the battery is replaced. ① With the meter off, turn the meter over to locate the battery cover. Press the battery cover tab on the top and lift the cover to open it. ② Remove and discard the old batteries.
32 Maintenance Caring for your system Avoid getting dirt, dust, blood, control solution, water, or any other liquid in the meter’s test strip port. Important: Never immerse the meter in water or any other liquid. This may cause inaccurate reading or meter malfunction. Storing your system Store your meter, test strips and other items in your carrying case after each use. Store each item in a cool, dry place .Test strips should be stored between 2℃~ 30℃ (35.6℉~86℉).
Maintenance 33 Test Strip Holder Remove the Test Strip Holder by pressing in on middle of the Test Strip Holder and sliding it out from the meter. Wipe it with a damp cloth or a mild detergent and dry it with a dry, soft cloth. Slide the Test Strip Holder back into the meter by laying it flat on the meter. Firmly press down on the center of the Test Strip Holder with your thumb and push it in until it clicks into place. Note: Do not use organic solvents, such as gasoline or paint thinner.
34 Maintenance Cleaning your lancing device • To clean, wipe them with a soft cloth dampened with water and mild detergent. Do Not immerse the lancing device in any liquid. • To disinfect, prepare a solution of one part household bleach to ten parts water. Wipe the lancing device with a soft cloth dampened with this solution. Immerse the caps only in this solution for 30 minutes. After disinfecting, rinse briefly with water and allow both to air dry.
35 Troubleshooting Message Possible Cause What to do No code chip or the chip is not well installed. Insert the code chip to the meter correctly. Test strip was removed during the test. Repeat the test and ensure the test strip remains in place. Specimen was applied to the test strip too soon. Repeat the test and apply specimen after blood drop symbol appears. Ensure the test strips are Used or dirty test strip with the expiration date printed on the canister label.
36 Troubleshooting No test record. Check the memory when test results are stored. the specimen was taken The test result is lower Iffrom a specimen container, than 4.5 g/dL . ensure the specimen is mixed well and repeat test. Repeat test and apply Insufficient specimen enough specimen.Use at less than 1µL least 10 µL of whole blood. If the specimen was taken The test result is higher from a specimen container, ensure the specimen is than 25.0g/dL. mixed well and repeat test. No. No.
Troubleshooting 37 Meter does not enter the test mode after inserting a test strip. Probable Cause The battery power is low. What to Do Replace the battery (and reset the date and time,if necessary.) The battery is installed incorrectly or there is no battery in the meter. Check that the battery is installed correctly. Test strip inserted upside down, wrong end in, or incompletely inserted into the meter. Insert the test strip with the printed side up and the top of the strip in the meter.
38 Technical information Specifications Meter Type Blood Sample HB-202 Capillary and Venous whole blood Blood Volume 10uL Test Strip Type HS-101 Measuring Range Measuring Time 4.5-25.0g/dL ＜15seconds Power 3*AAA Battery or TypeC USB DC5V Battery Life Approximately more than 2000 tests Memory Capacity Operation Environment 1000 test results 10℃～40℃ (50℉ ～104 ℉) <90%RH (non-condensing) -20℃～55℃ (-4℉ ～131℉) <90%RH (non-condensing) Meter storage environment Strip storage environment 2℃～30℃ (35.
Technical information Specifications Automatic power off Approx.3 minutes after last user action Data transmission with Usb data cable,can be connected to the computer for data management Unit of measure Repeatability Accuracy g/dL,g/L or mmol/L 4.5-10.0g/dL,Standard Deviation (SD)≤0.8g/dL. 10.1-25.0g/dL,Coefficient of Variation (CV)≤3%. 4.5-10.0g/dL, absolute deviation≤1g/dL. 10.1-25.0g/dL, relative deviation≤4%.
40 Disposing of the meter,test strips,lancets and batteries Warning • Any product coming in contact with blood is considered contaminated (potentially infectious). • During normal testing, any Hemoglobin meter may come in contact with blood. • Lancing devices may also be considered sharps. Disposal of sharps is regulated by law in many jurisdictions. Comply with any laws or ordinances relating to the disposal of sharps and/or contaminated products.
Warranty 41 Limited 2-Year Warranty The meter is guaranteed for 2-year from the date of purchase. If the meter does not function properly due to defective components or poor workmanship, we will repair or replace it freely. This warranty does not cover damage due to improper handling in any way. Battery does not included in the warranty.
42 Symbol Index Consult instructions for use In vitro diagnostic medical device SN Serial number Caution Batch code Manufacturer 55℃ -20℃ Storage temperature limitation Storage humidity limitation Do not reuse Use by
Symbol Index Biological risks Keep dry This symbol indicates that you should not discard waste electrical or electronic equipment (WEEE) in the trash.
FCC Warnning: Any Changes or modifications not expressly approved by the par ty responsible for compliance could void the user's authority to operate the equipment. This device complies with par t 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful inter ference, and (2) this device must accept any inter ference received, including inter ference that may cause undesired operation.
Document No.: DHB-0202-010 Version:Z Date of Issue: 2020.09 Distributed By: Manufactured by Hangzhou Sejoy Electronics & Instruments Co., Ltd. Area C, Building 2, No.365, Wuzhou Road,Yuhang Economic Development Zone,Hangzhou City 311100 Zhejiang China.
