HemoSmart brochure
Contents
1. 2o B E LOT Batch code mE gg WC c Temperature limitations dd M ES Li Consult instructions for use i E vo In vitro diagnostic device lt S A Caution warning consult accompanying documents o REF Product code number 3 amp Keep away from sunlight direct light Do not re use mi Manufactured by Authorised Representative in the European Community 30 6 Hemo manual 911 2010 2011 10 27 5 09 PM oe 31 Chapter 11 Product Warranty The HemoSmart M Meter is guaranteed to be free of defects in workmanship and materials under normal use for a period of three 3 years from the date of purchase to the consumer The liability of Apex Biotechnology Corp is limited to repair or replacement and in no event TI 1eidej shall Apex Biotechnology Corp be liable for any collateral or consequential damages or loss T amp 8 p B a Instruments subjected to misuse abuse neglect unauthorized repair or modification will be excluded from this warranty This guarantee specifically excludes expendables and consumables such as test strips and lancets All warranty claims must be directed to the Apex Biotechnology Corp authorized dealer re sponsible for the sale of the system The warranty applies only to the original purchaser of the system 31 62. Relative Humidity Less than 85 Storage Operating and Transportation Storage Transport Condition 4 C to 55 C 39 F to 131 F for meter 4 C to 30 C 39 F to 86 F for test strip Electromagnetic Compatibility This equipment is complying with EMC requirement of EN 60601 1 2 27 6 Hemo manual 911 2010 2011 10 27 5 08 PM oe 28 ANOTE For more information regarding the test strips see the test strip package insert found in each A box of test strips T 9 8 Applied Product Standards o E c IEC 61010 1 IEC 60601 1 8 EN 61010 1 EN 60601 1 2 EN 61326 EN 62366 EN 61010 2 101 EU directive classification 98 79 EC Other IVDs Classification according to IEC EN 60601 1 IPXO not evaluated as AP APG equipment continuous operation Electromagnetic Compatibility This equipiment is complying with EMC requirement of EN 60601 1 2 28 6 Hemo manual 911 2010 2011 10 27 5 08 PM oe 29 Chapter 9 Supplies Part Number S25001 S5636036 S5636074 65235010002 80050000003 S5800038 Product Name HemoSmart Total Hemoglobin Basic HemoSmart Total Hemoglobin Test Strips 25 s HemoSmart Total Hemoglobin Test Strips 2x25 s Lancing Device Lancets 28G 50 s HemoSmart Hemoglobin control solution lt sorjddns 6 JadeyoD 29 Hemo manual 911 2010 2011 10 27 5 09 PM oe 30 Chapter 10 Symbols Used in this Manual lt a EXP Expiration date use by last day of month
3. ANIMPORTANT Please make sure the HemoSmart meter is properly coded Refer to Chapter 3 p 14 Coding the Meter Lli el 11 oe Hemo manual 911 2010 2011 10 27 5 08 PM oe 12 Step 1 Insert the Monitor Checker arrow end into the Test Strip Holder ZJ until you hear a beep A Step 2 When the Meter Display Screen shows smiling face remove the Monitor Checker lt Step 3 The screen will then display the current code number being used c JadeyD Verify that code number on screen is the same with the code num Sunsa ojog ber printed on the strip package Step 4 Remove a brand new HemoSmart Hemoglobin Test Strip from the strip bottle and insert it into the test strip holder of the meter The screen will show ctr This will ensure the control results will not be stored into memory Step 5 When the screen show a symbol 4 apply a drop of HemoSmart Control Solution at the reaction zone of the test strip as shown Step 6 The display screen will show timing bars The bars will flash and gradually diminish for countdown 6 12 Hemo manual 911 2010 2011 10 27 5 08 PM oe 13 Step 7 After the timing bars disappear approximately 10 seconds the l E Level 1 11 13 g dL screen will show test result Compare the reading on the screen to y Q the control range indicated on the test strip bottle The test result falling within the range means the Meter
4. HemoSmart M kit package includes the following items HemoSmart Meter 1 User s Manual 1 Monitor Checker 1 Carrying Case 1 Adjustable Lancing Device 1 The kit contents may vary in some certain areas Contact the dealer if you find difference from the above amp Hemo manual 911 2010 2011 10 27 5 08 PM oe 5 HemoSmart Meter Front HemoSmart Display Screen Large easy to read window guides you through testing displaying results and error messages using simple words or symbols Push Button Recalls test results in the memory Refer to chapter 4 p 20 Using Meter Memory for details Test Strip Holder Insertion site for test strips and monitor checker 6 lt urojs amp g Suruoo1oS urgo 80uroeH j 11eurgouroH 1nox 3noqy g Jaydeyo h lt uIo s S Suruoo1og urgo 8ouioeH j1reurgourog Inox ynoqy g 9deyp HemoSmart N vb C n ttal Apex Biotechnology Corp No 7 Li Hsin Rd V Hsinchu Science Park Hsinchu Taiwan R O C Tel 886 3 5641952 Fax 886 3 5678302 HS 525001 E PIN 59106000028 525004 REV 8 0 nd manual 911 2010 2011 10 27 5 08 PM oe 6 Code Card Port Insertion site for the code card Battery Compartment Holds one 3V Lithium coin cell battery CR2032 Refer to Chapter 6 p 23 Changing the Battery 6 Monitor Checker Use to confirm the Meter is functioning properly Refer to Cha
5. and the Test Strip are working together properly c Jadeyo Sunsog opg Step 8 Remove the Test Strip The meter will turn off automatically ANIMPORTANT 1 Do not use test strip that has expired Check the expiration date amp that is printed on the strip bottle 2 Use each test strip immediately after removing it from the strip bottle 3 Do not use wet bent or scratched strips 4 Do not reuse test strips and lancets 5 Keep away from direct sunlight and heat Store the strips in a dry cool place 6 If the test result is not within the expected range repeat the control solution testing If the results continue falling outside the expected range call our authorized dealer 13 6 Hemo manual 911 2010 2011 10 27 5 08 PM oe 14 4 Sunsog urqo gouroeH S N J0 dey 14 Chapter 3 Hemoglobin Testing Coding the Meter Before you can begin testing on your HemoSmart Meter you must code the meter Coding the Meter ensures accurate test results when you perform a test A new code card is packaged along with each box of HemoSmart Hemoglobin Test Strips Materials your will need A code card for the HemoSmart Hemoglobin Test Strips e A HemoSmart Hemoglobin Test Strip Your HemoSmart meter A NOTE Make sure the HemoSmart Hemoglobin Test Strips are not expired Check the test strip ex piration date on the box and the test strip bottle The month printed re
6. meter adjust to the new temperature Discard the used test strip from the meter and retest with a new test strip Check if you are using the right code card Repeat testing L Ideo a VA yn 2 gs o o E 3 E o i cn o 5 amp 2 o J o 25 Hemo manual 911 2010 2011 10 27 5 08 PM oe 26 Message Meaning What To Do HI The hemoglobin result is Check if your are using the right code higher than 20g dL card Repeat testing 4 A sd o soi 2 own amp 1 A used test strip is in Remove and discard the used test strip 5 v 3 serted then perform the Monitor E 2 The meter does not Checker Test on p 9 Li If the prob S function properly lem persists contact our authorized amp dealer for service z 8 J o If you are unable to correct the problem after following the What To Do procedures call our authorized dealer in your country and or contact your healthcare professional with guestions and concerns 26 6 Hemo manual 911 2010 2011 10 27 5 08 PM oe 27 Chapter 8 Specifications lt Test Strips HemoSmart Hemoglobin Test Strips Test Range 4 20 g dL 20 Sample Volume 3uL 5 Reading Time 10 Seconds g a Blood Source Capillary whole blood S i Display Type Large LCD screen Memory 10 test result Dimension 100Lx58Wx21H mm Weight 64g Power Supply 1 x 3V Lithium coin cell battery CR2032 Operating Temperature 18 C to 38 C 64 F to 100 F
7. see HemoSmart He Sunsay o19jog 4 moglobin Test Strip insert for temperature ranges Practice the test procedure ANIMPORTANT The acceptable range for the control solution is listed on the package of test strips Use only the HemoSmart Control Solution e Always check the expiration date amp DO NOT use control solution if expired Newly opened bottle of control solution must be marked with the date opened discard any unused control solution 1 months after opening or expiration date DO NOT freeze Control solutions should be stored at 2 C to 8 C 4 36 F to 46 F If a control solution test is not within the expected range that is printed on the test strip 6 10 Hemo manual 911 2010 2011 10 27 5 08 PM oe 11 package DO NOT use the meter to test Repeat the test until a control solution test per forms within the expected range If the results continue falling outside the expected range call the authorized dealer for service DO NOT touch the test area with the tip of the control solution bottle DO NOT apply a second drop of control solution to the test strip Replace the bottle cap on the control solution bottle immediately after use SupsopoloJog Mf c Ideyo 4 Materials you will need e HemoSmart Control Solutions optional items contact our authorized dealer for purchas ing information A fresh new HemoSmart Hemoglobin Test Strip Your HemoSmart Meter
8. the temperature ranges be 6 4 IJN o 107 Sure y 1ogdeu 4 21 q k lt sadeyp IJN o 107 Sure 22 Hemo manual 911 2010 2011 10 27 5 08 PM ase 22 tween 18 C to 38 C 8 64 F to 100 F Avoid leaving the Meter in extremely hot or cold place such as near a heat source or in an extremely hot or cold car Do not store or use the Meter or Test Strips where they may be exposed to high humidity levels such as in a bathroom or kitchen Never immerse or hold the Meter under running water Always replace the bottle cap immediately after removing a Test Strip and make sure the test strip bottle is closed tightly DO NOT take the HemoSmart Meter apart If there are technical problems or questions in use of the meter call the authorized dealer Hemo manual 911 2010 2011 10 27 5 08 PM oe 23 Chapter 6 Changing the Battery The HemoSmart M Meter operates on one 3V Lithium coin cell battery When the LCD screen displays this indicates the battery is low and should be replaced as soon as possible ANOTE To save battery power the HemoSmart Meter will turn itself off after 3 minutes of non use All results stored in memory will be saved even if the meter shuts off automatically Discard used battery according to your local regulation To replace the battery Step 1 Open battery compartment cover on backside of the Meter Step 2 Remove the old battery an
9. to test ANNOTE If the temperature is outside of the operating range the Meter needs to be moved to an area that is within the Meter s operating range of 18 C to 38 C 4 64 F to 100 F and allow 10 to 15 minutes for it to reach the new temperature before use Measurement outside the tempera ture range will affect accuracy of test result Step 2 Wash hands with soap and warm water and dry thoroughly Step 3 Hold the lancing device puncture or lancet against the side of the finger and lance the finger Follow manufacturer s instruction for how the lancing device puncture or lancet should be used 6 lt Surjso urgo 8ouioeg Igdeuj Um Hemo manual 911 2010 2011 10 27 5 08 PM oe 18 Step 4 Apply blood as shown When the reaction zone has filled completely the Meter will beep indicating that blood has been received by the test strip Gently message your hand and finger toward the punc lt E 2 ture site to form a drop of blood approximately Do not milk or 3 squeeze around the puncture site w EF Step 5 The meter screen will display timing bars that will flash and F gradually diminish for countdown B Step 6 After the timing bars disappear approximately 10 seconds the screen will display test result along with a calculated Hematocrit Hct value Both the hemoglobin test result and the calculated haematocrit value are automatically stored into the Meter s mem
10. Hemo manual 911 2010 2011 10 27 5 08 PM oe ul Table of Contents 1 About your HemoSmart Hemoglobin Screening System uf Contents of RE cd e de a nea se eahe eee cleat la hand cama eas kon NS PE tiens 4 d HemoSmart Hemoglobin Meter sse 5 HemoSmart Hemoglobin Test Strip ssseeem 7 a HemoSmart Control Solution optional 8 S o 3 2 Before Testing Monitor Checker Test ssssssssssseseenen eene nennen enne 9 Quality Control Testing irre rc oer Re serre ee Ee eec ree 10 3 Hemoglobin Testing eroe neBurar cp 14 Performing a Hemoglobin Test esssseeee eene 16 Understanding the test resule eeseeseeee enne 19 4 Using Meter Memory ssssssesseeee nennen rennen 20 1 Hemo manual 911 2010 2011 10 27 5 08 PM oe 2 v d amp S o o o o El o i 2 wu 5 Caring for the Meter Cleaning the Meter ue ace ipte de poet be mec ter cai dbi P cet eade 21 Storage and Precautions ssssssssssseeeee nennen nennen nnne nenne 21 6 Changing the Battery sssssssssssseeeeeeneen eene nnne nenne 23 7 Messages Interpretation amp What to do sssssm 24 8 Specificatlons osi ie i ded YT Dd teint LA RU ndn Ga CL AR Hed ee ex BR ARE ona dae nt 27 9 Suppli amp S uu 29 10 Symbols Used in thi
11. d replace with one new 3V Lithium coin cell battery Step 3 Replace the battery compartment cover 6 lt Koneg oy SursueyD 9 adeyyo 23 Hemo manual 911 2010 2011 10 27 5 08 PM oe 24 Chapter 7 Messages Interpretation amp What to Do 4 N v Ee O zo o E Message E code then 3 the meter shuts off in 3 seconds e J o en 24 Meaning The meter has not been coded with a code card The meter has not been coded with a code card amp If there is a problem with the way you are performing a test or if there is a problem with your HemoSmart Meter any of the following messages may appear on the meter screen If you have further questions after reviewing these messages call our authorized dealer What To Do Code your Meter with a HemoSmart Code Card see Chapter 3 p 14 Coding the Meter Code your Meter with a HemoSmartTM Code Card see Chapter 3 p 14 Coding the Meter Hemo manual 911 2010 2011 10 27 5 08 PM oe 25 Message Code number and flashing display after blood is ap plied LO Meaning The temperature of the surrounding air is out side of system operation range Not enongh blood sam ple is applied to the test strip The hemoglobin result is lower than 4g dL oo What To Do The meter needs to be moved to an area that is within 18 C to 38 C 4 64 F to 100 F Wait for 10 15 min utes to let the
12. ease contact your physician or healthcare professional immediately 19 6 Hemo manual 911 2010 2011 10 27 5 08 PM oe 20 Chapter 4 Using Meter Memory Your HemoSmart Meter can automatically store 10 test results When more than 10 test re sults are stored the oldest result will be dropped from memory each time a new result is c o E E added When the test results are recalled from memory the most recent result is always dis s played first o z 8 To recall results from memory E Step 1 Press the push button to turn on the Meter The screen will display the latest test result stored in memory Step 2 Repeat pressing the push button for reviewing further test results in memory 20 Hemo manual 911 2010 2011 10 27 5 08 PM oe 24 Chapter 5 Caring for the Meter Cleaning the Meter Your HemoSmart Meter does not require special cleaning If the Meter gets dirty use a moist NOT WET lint free cloth dampened with a mild detergent ANOTE 1 DO NOT get water inside the HemoSmart Meter Never immerse the meter or hold it under running water 2 DO NOT use glass cleaners or household cleaners on the Meter 3 DO NOT try to clean the Test Strip Holder 4 DO NOT contaminate the strip holder with blood or control solution NStorage and Precautions e Handle the Meter with care Severe shock such as dropping the Meter could damage the electronics The Meter and the Test Strips are designed to be used within
13. fers to the end of the month Step 1 Locate the code card w in the package of Test Strip Step 2 Verify that the code number on the code card matches the code number on the Test Strip package 6 Hemo manual 911 2010 2011 10 27 5 08 PM oe 15 Step 3 Step 4 Step 5 Insert the code card with the code number facing up firmly and completely into the code card port on the backside of the meter Obtain a Test Strip 89892 and insert the strip into the test strip holder located at front bottom of the meter The meter will turn on with a beep sound Close the Test Strip bottle immediately after you take out a strip A 3 digit code number will display on the meter screen Verify the code number on The code number displayed on the Meter should match the code number on the code card and on the front of the Test Strip package HemoSmart Test Strips diagnostic use range m the screen with that on the code card and that on the test strip package All three sets of numbers should be the same ANOTE 1 The code card found in the HemoSmartTM Hemoglobin Test Strip package is for use with that particular package only Different packages of HemoSmart Hemoglobin Test Strips amp o a o qa o 2 3 E 5 ga Q E Ae o w 15 Hemo manual 911 2010 2011 10 27 5 08 PM oe 16 N adeyyo Sumsog urgo 8ouioegg lt 16 and other brands of test strips will p
14. ory refer to Chapter 4 p 20 Using Meter Memory Lli The meter will auto matically turn off after the Test Strip is removed or after 3 minutes ANIMPORTANT The HemoSmart Hemoglobin Screening System is primarily use for the assay of hemo globin value in the indicated range of 4 g dL to 20 g dL only and is not intended as a tool for the diagnosis of anemia or any other hemoglobin related illnesses If LO under 4 18 6 Hemo manual 911 2010 2011 10 27 5 08 PM oe 19 g dL or HI over 20 g dL readings appears a more suitable method may be required to perform further testing Discard used test strip and lancets according to your local disposal regulations where appli cable e Carefully discard used test strip and lancets in proper waste E E containers de E SS DO NOT touch the target area of the test strip O En DO NOT smear the blood drop onto the target area l bi DO NOT add or apply a second drop of blood This may cause false result B DO NOT proceed testing if the yellow window is not full of blood sample Insufficient blood sample may cause inaccurate test result Understanding the test result Ideal range for male is 13 18 g dL Ideal range for female is 11 5 16 g dL If the result is lower than 10 g dL it could be low hemoglobin or iron deficiency anemia If the result is higher than 19 g dL it could be erythrocytosis If the result is higher than 19 g dL or lower than 10 g dL pl
15. pter 2 p 9 Monitor Checker Test for details Hemo manual 911 2010 2011 10 27 5 08 PM oe 7 HemoSmart Hemoglobin Test Strip Sold Separately Contact Points Test Strip Handle Reaction Zone Apply Blood Here Contact Points Sense the position and orientation of the Test Strip Test Strip Handle The only area to be touched when handling the Test Strip Reaction Zone The area where the blood sample is applied The HemoSmart Hemoglobin Test Strip is a biosensor based test strip uniquely designed to specifically detect total hemoglobin in whole blood using the HemoSmart M Meter The Test Strips come in a moisture proof light protected bottle It is important the bottle is kept well sealed at all times Replace cap immediately after taking a strip out of the bottle amp lt uIo s S Suruoo1oS urgo 80uroeH wy Ieurgourog 1nox noqy g JaydeyD Hemo manual 911 2010 2011 10 27 5 08 PM oe 8 HemoSmart Control Solution optional lt DQ EE CN EB ga Sp Go ler SE l zl F Solution with standard concentration of reactive substance in hemoglobin It is required to 9 perform the Quality Control Testing in Chapter 2 p 10 Lli Use the solution to check for E system accuracy practice test procedure and when using a new lot of HemoSmart Hemo E globin Test Strips 5 E amp Store the HemoSmart Control Solution at
16. roduce inaccurate results 2 Re coding needs to be done when a new package of test strip is opened for use 3 Code number displayed on screen not matching the code number printed on the test strip bottle or package will create an inaccurate test result Performing a Hemoglobin Test Materials you will need A brand new HemoSmart Hemoglobin Test Strip Your HemoSmart Meter ANIMPORTANT 1 Do not use test strip that has expired Check the expiration date amp that is printed on the Test Strip Bottle and Box 2 Use each Test Strip immediately after removing it from the bottle 3 Close the bottle cap immediately afetr removing a Test strip 4 Do not use wet bent or scratched Test Strip 5 Keep away from direct sunlight and heat Store the Test Strip bottle in a dry cool place 2 6 Record the date opened on the Test Strip bottle label when you first open it After 1 6 Hemo manual 911 2010 2011 10 27 5 08 PM oe 17 months since first opened date discard the bottle and any remaining test strips 7 Do not reuse test strip and lancets Step 1 After you have performed the previous section Coding the Meter the meter will now self test the environment temperature If the temperature is below or above oper ation range the screen will display the flashing symbol of thermometer When the temperature is within the testing range of 18 C to 38 C 64 F to 100 F the screen will show 6 and the Meter is ready
17. s Manual sse 30 11 Product Warranty terror rer etre dd YG Y ee eee 31 Hemo manual 911 2010 2011 10 27 5 08 PM oe 3 Chapter 1 About Your HemoSmart Hemoglobin Screening System Thank you for choosing the HemoSmart Hemoglobin Screening System All of the infor mation that will be needed to use and maintain the HemoSmart M System is included in this manual Read it carefully before using the system Utilizing Biosensor Technology the HemoSmart System provides an easy and precise way of measuring the level of total hemoglobin in whole blood The results are referenced by CBC cell counter method which means the data gathered from the HemoSmart Screening System is comparable to the results in a clinical laboratory The HemoSmart Hemoglobin Screening System is intended for use outside the body in vitro diagnostic use and is useful for quantitative screening of hemoglobin in the range of 4 g dL to 20 g dL The HemoSmart Screening System is for a low or a high concentration of he moglobin for the health of the patient e g anemias low Hb erythrocytosis high Hb tha lassemias aberrant chain synthesis and sickling disorders abnormal complex shape 6 urojs amp g Suruoo1oS 4 h urqo SouroeH x Ieurgourog 1nox noqy g JaydeyD amp N lt uIo s S S8uiuooJos urgo 8ouIoeH j11eurgourog Inox ynoqy Jo deu Hemo manual 911 2010 2011 10 27 5 08 PM oe 4 Contents of Kit The
18. temperatures at 2 C to 8 C 4 36 F to 46 F EA See the HemoSmart Control Solution insert for more information 5 Please contact your local supplier to order control solution 8 6 Hemo manual 911 2010 2011 10 27 5 08 PM oe 9 Chapter 2 Before Testing Monitor Checker Test The Monitor Checker Test will help ensure that the electronics in your HemoSmart Meter is working properly This test should be done on a brand new meter or when the performance of the meter needs to be confirmed Materials you will need Monitor Checker included in kit Your HemoSmart Meter Step 1 Insert the Monitor Checker Arrow end into the Test Strip Holder until you hear a beep Step 2 When the Meter Display Screen shows 9 happy face means your Meter is function ing properly If the display screen shows sad face then repeat the procedure once more If continues to appear refer to Chapter 7 p 24 Li Messages Interpreta tion amp What to do 6 lt q 1deu Sunsa opg Hemo manual 911 2010 2011 10 27 5 08 PM oe 10 Quality Control Testing Perform Quality Control Testing when b a You first get your Meter before performing a hemoglobin test You first begin to use a new package of HemoSmart Hemoblogin Test Strips You suspect your HemoSmart Meter and Test Strips are not working properly c JadeyD When your Test Strips have been exposed to extreme temperatures
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