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Summary of Contents for Sejoy HB-101
- Page 1 Hb Hemoglobin Testing System HB-101 Owner’s Booklet Realiable Hemoglobin Testing System...
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Page 2: Table Of Contents
Contents Introduction ························································ ······································· Important Safety information ······························· Important Health-Relate information Getting to know your system ·································· ·········································· Meter (battery included) ····················································· Meter Display ························································ Test Strips ···················································· Lancing Device Setting up your meter············································· ······················································· Meter Setup ············································ Optical heck ·················································... -
Page 3: Introduction
Before you start testing, carefully read this Intended Use The Sejoy HB-101 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... -
Page 4: Important Safety Information
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. -
Page 5: Important Health-Relate Information
– or if you have questions – talk to your doctor. The sejoy hemoglobin monitoring system HB-101 is designed for using • with fresh capillary whole blood from the finger or venous samples. -
Page 6: Getting To Know Your System
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 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... - Page 7 Getting to know your system 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.
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Page 8: Meter (Battery Included)
Getting to know your system a. Meter Mini USB Right Arrow Button On/Off Button Left Arrow Button Strip Channel Test strip Holder Code Chip Battery Cover 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. -
Page 9: Meter Display
Getting to know your system b. Meter Display Low Battery Date and Time Reminder Test Strip Reminder Apply Blood Sample Out of optimal operating temperature Reminder ℃~ ℃ Code Number indicator or Test Result Measurement Memory Units Code Sound Icon HCT Value Sound Icon: Appears when the sound is turned on. -
Page 10: Test Strips
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. - Page 11 Getting to know your system 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.
- Page 12 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. •...
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Page 13: Lancing Device
Getting to know your system c. Lancing Device Trigger Button Sliding Barrel Arrow Adjustable Tip Protective Cover Lancing Device Cover Lancet Carrier Lancet Ejector d. Lancet Protective Cover Lancet Pin... -
Page 14: Setting Up Your Meter
Setting up your meter Setting up your meter 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. - Page 15 Setting up your meter Setting up your meter ① Set the year The year will appear at the top of the display. ◄ or ► ► until the correct year is displayed. Press Press button to save and the Month and Date figure is flashing automatically.
- Page 16 Setting up your meter Setting up your meter Setting up your meter ⑤ Set the time The hour and minutes will appear at the top of the display ◄ or ► separated by a colon, with flashing hour. Press until the correct hour is displayed. Press to save and proceed to HOUR.
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Page 17: Optical C Heck
Setting up your meter Setting up your meter Setting up your meter Optical heck with the meter turned off, press and hold for 2 seconds to enter Meter Setup mode. Press until PC is display.Press ◄ or ► enter optical check mode,insert the quality control strips,and then press to start the optical system inspection. -
Page 18: Coding Your Meter
Setting up your meter Setting up your meter Coding your meter ① Check the code on the test strip vial before inserting the test strip CODE Code numbers are used to calibrate your meter with the test strips you are using LOT ：... - Page 19 Setting up your meter ④ Match the code on the meter with the code on the test strip vial CODE • If the code on the meter match the code on LOT ： the test strip vial, the meter is now ready to Expiration date ：...
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Page 20: Testing
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. - Page 21 Testing Preparing the lancing device ① Twist off the lancing device cover. ① 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.
- Page 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.
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Page 23: Fingertip Blood Sampling
Testing 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. - Page 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.
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Page 25: Disposal The Lancet
Testing 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. - Page 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.
- Page 27 Testing 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℃...
- Page 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.
- Page 29 Testing 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.
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Page 30: Data And Memory
Data and memory Deleting Data To delete all data from the meter database, enter the Setup Menu ◄ or ► (refer to Section 4 Meter Setup). Press until dEL is displayed. Press to delete all data. After flashing, all data will be cleared and dEL will be displayed again. -
Page 31: Maintenance
Maintenance Replacing the battery “ ” If your battery runs low, the battery symbol appears on every display 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. -
Page 32: Caring For Your System
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. - Page 33 Maintenance 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.
- Page 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.
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Page 35: Troubleshooting
Troubleshooting Message Possible Cause What to do No code chip or the Insert the code chip to the chip is not well meter correctly. installed. Repeat the test and ensure Test strip was the test strip remains removed during in place. the test. - Page 36 Troubleshooting Check the memory when No test record. test results are stored. If the specimen was taken The test result is lower from 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...
- Page 37 Troubleshooting Meter does not enter the test mode after inserting a test strip. Probable Cause What to Do Replace the battery (and reset the date and The battery power is low. time,if necessary.) The battery is installed incorrectly or there is no Check that the battery is installed correctly.
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Page 38: Technical Information
Technical information Specifications HB-101 Meter Type Capillary and Venous whole blood Blood Sample Blood Volume 10uL Test Strip Type HS-101 Measuring Range 4.5-25.6g/dL,45-256g/L,2.8-15.9mmol/L ＜ 10seconds Measuring Time 3*AAA Battery or MiniUSB DC5V Power Approximately more than 2000 tests Battery Life... - Page 39 Technical information Specifications Approx.3 minutes after last user Automatic power off action Unit of measure g/dL,g/L or mmol/L 4.5-10.0g/dL,Standard Deviation (SD)≤0.8g/dL. Repeatability 10.1-25.6g/dL,Coefficient of Variation (CV)≤3%. 4.5-10.0g/dL, absolute deviation≤1g/dL. 10.1-25.6g/dL, Accuracy relative deviation≤4%.
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Page 40: Disposing Of The Meter,Test Strips,Lancets And Batteries
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. -
Page 41: Warranty
Warranty 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. -
Page 42: Symbol Index
Symbol Index Consult instructions for use In vitro diagnostic medical device Serial number Caution Batch code Manufacturer ℃ Storage temperature limitation ℃ Storage humidity limitation Do not reuse Use by... - Page 43 Symbol Index 0123 The product conforms to the requirements of the CE mark in vitro diagnostic medical devices 0197 Biological risks Keep dry This symbol indicates that you should not discard waste electrical or electronic equipment (WEEE) in the trash. For proper disposal, contact your local retailer where product was purchased Direct Current European Authorized Representative...
- Page 44 Document No.: DHB-0104-002 Version:B Date of Issue: 2021.5 Distributed By: Hangzhou Sejoy Electronics & Instruments Co., Ltd. Area C, Building 2, No.365, Wuzhou Road,Yuhang Economic Development Zone,Hangzhou City 311100 Zhejiang China. The product is in compliance with the 0123 requirements of IVD 98/79/EEC,"0123" is the identification number of notify body Shanghai International Holding Corp.
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