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1. Professional Hemoglobin Testing System USER S MANUAL Read this user s manual and the Hgb Pro test strip package insert prior to use For in vitro diagnostic use CLIA Category Waived INTENDED USE The Hgb Pro Professional Hemoglobin Testing System consists of a portable battery operated meter and single use test strips for the quantitative measurement of total hemoglobin from capillary and venous whole blood The System is designed for near patient testing in a professional facility and is not intended for home use VALUE OF HEMOGLOBIN MEASUREMENT Hemoglobin is the oxygen carrying protein in red blood cells The quantitative measurement of hemoglobin is indicated and clinically useful in acute illness as well as in general care The normal range hemoglobin values reported in medical literature are gender and age dependent Adult males 13 5 18 0 g dL Adult females 12 0 16 0 g dL Infants Ranging from 14 5 22 5 g dL after birth to 11 1 14 1 g dL at 6 months Children Gradual increase from infant to adult levels Low hemoglobin levels may indicate conditions such as anemia or hemorrhage Elevated hemoglobin levels may indicate conditions such as polycythemia A hemoglobin test may be used as part of a general screen for many types of patient populations including the elderly children and women of child bearing age and prior to giving or receiving transfusions Due to differences among patient populations2. Tips for applying a fingerstick blood sample to the meter e A single blood drop of at least 15ul of blood must be applied e DO NOT remove the test strip to apply the blood sample the test strip must stay inserted in the meter The meter may be lifted to the patient s finger for blood application e DO NOT touch the finger directly to the test spot membrane e DO NOT overfill the test spot add enough blood to completely fill the test spot only e DO NOT add more blood once blood has already been applied to the test spot Note f a sample s obtained trom a venipuncture apply a blood drop tree of bubbles to the test spot from the syringe opening or needle Do not touch the syringe opening or needle directly onto the test spot Step 9 Read Result The blood sample will spread and the meter will automatically begin the test While the test is in progress do not disturb or move the meter or test strip or press any of the meter buttons The result will be displayed as hemoglobin units as defined in SET UP OPTIONS in either g dL or mmol L in less than 30 seconds and will remain on display for 2 minutes after test completion After the test is completed remove the test strip and dispose according to standard methods for biohazard control The meter will automatically shut off after 2 minutes of inactivity or can be turned off by pressing the button The test result will be stored automatically with its date and time stamp w
3. by Skin Puncture For fresh whole blood venous samples collect approximately 0 1mL into an anticoagulant free plastic syringe and apply a blood drop to the test spot from the syringe in place of steps 7 and 8 of the test procedure Refer to NCCLS Document H3 A5 Procedure for the Collection of Diagnostic Blood Specimens by Venipuncture TEST PROCEDURE The user should review all instructions in this User s Manual and the Hgb Pro Package Insert prior to using the meter Follow the instructions in SET UP OPTIONS in this manual for setting the time date and reporting units prior to the first use of the meter Materials Provided and Materials Needed But Not Provided Po Catalog No HGBPROKIT Catalog No HGBMETER Catalog No HGBTEST100 Materials e Hgb Pro Meter e Hgb Pro Meter e Hgb Pro Hemoglobin Provided Test Strips e Hgb Pro User s Manual e Hgb Pro User s Manual e Hgb Pro Test Strip e Hgb Pro Hemoglobin Test Strips e EZ Guide Package Insert e Hgb Pro Test Strips Package Insert e EZ Guide e Training CD ROM Materials Needed But Not Provided e Hgb Pro Hemoglobin Test Strips e Hgb Pro Meter e Hgb Pro Test Strip Package Insert e Hgb Pro User s Manual e Liquid Quality Controls see Section QUALITY CONTROL in Test Strip packaga insert e Incision or fingerstick device e Alcohol pad e Gauze e Bleach for cleaning the meter Step 1 Start the Meter Press the button to turn the meter on The meter automatically monitors i
4. test result performed or the entire memory The user can cancel out of erasing test results by turning off the meter by pressing the Q button prior to display of MEM Step 1 Remove the test strip holder Turn the meter on by pressing the button Wait until the meter displays the Lot Code time and date Erase the Last Test Result Step 2 Press the SET button twice CLE will be displayed Step 3 Press and hold the SET button until CLE flashes After releasing the SET button the most recent test result will be displayed Note 70 cancel out of the CLE function without erasing the result turn off the meter Step 4 To erase the result press and hold the SET button The test result will flash and when erased will be replaced by MEM represents the test result sequence number The symbol will replace that test result in the memory until replaced by a new test result Erase the Entire Memory Step 2 Press the SET button three times CLA will be displayed Step 3 Press and hold the SET button until CLA flashes After releasing the SET button ALL will appear Note 7o cancel out of the CLA function without erasing the entire memory turn off the meter Step 4 To erase the entire memory press and hold the SET button When the entire memory is erased ALL will be replaced by MEM Upon completion of the memory functions turn off the meter and place the test strip holder on the meter TROUBLESHOOTING An
5. the original purchaser s or user s remedies being limited to repair or replacement at the manufacturer s option Unauthorized modification of the Hgb Pro Professional Hemoglobin Testing System will void the warranty REFERENCES 1 Vengelen Tyler V Ed Technical Manual 13th Ed Bethesda MD American Association of Blood Banks 1999 753 754 2 Neuberger A and E L Tatum Ed Frontiers of Biology North Holland Publishing Co 1970 p 18 Hemoglobin and Myoglobin in Their Reactions with Ligands Antoini E and M Brunori 3 NCCLS Guidance Document EP7 A Interference Testing in Clinical Chemistry 4 NCCLS Document H4 A4 Procedures for the Collection of Diagnostic Blood Specimens by Skin Puncture 5 NCCLS Document H3 A5 Procedure for the Collection of Diagnostic Blood Specimens by Venipuncture TECHNICAL ASSISTANCE For technical assistance contact ITC Technical Service at 1 800 631 5945 or 1 732 548 5700 fax number 1 732 632 9299 or by email at techservice itcmed com General Hgb Pro product information can be obtained at the ITC website at www itcmed com or www hgbpro com NCCLS guidelines can be obtained at www nccls org or by calling NCCLS at 1 877 447 1888 CLI A waivedlom CLIAwaived com 4332 Corte de la Fonda San Diego CA 92130 Toll Free 888 882 7739 Phone 858 481 5031 FAX 801 720 7568 www cliawaived com HGO155 7 05
6. the Lot Code printed on the test strip container See TEST PROCEDURE for changing the Lot Code Test Strip Handling When handling the Hgb Pro test strip do not touch the test spot membrane INCORRECT Test Strip Insertion Into Meter Ensure the test strip is inserted into the meter with the notched end in first and the printing facing up Do not insert the test strip with the printing facing down or the notched end toward the back as the meter will be unable to properly read the test Do not insert the test strip so that it is skewed INCORRECT 7 ax CORRECT INCORRECT Test strip is upside down Test Strip is skewed Blood Sample Application To help avoid sample errors become skilled at obtaining CORRECT NC ORRECT blood with the fingerstick technique Do not obtain a fresh whole blood sample prior to preparing the meter and test strip as described in TEST PROCEDURE Do not touch the test spot membrane directly with the finger apply only a hanging drop of blood to the test spot SAFETY STANDARDS The Hgb Pro Professional Hemoglobin Testing System complies with the following safety standards and directives International Standard European Standard UL 61010 A1 Electrical Equipment for Laboratory Use Part 1 N A General requirements CAN CSA C22 2 Safety requirements for electrical equipment for measurement control and laboratory use Directive 89 336 EEC General requirements Council Directive 1989 336 EE
7. the Test Strip Remove a test strip from its container Examine the strip Do not use if there are tears wrinkles or debris Do not touch the test membrane Reseal remaining strips in the original container Step 5 Insert the Test Strip Insert the test strip into the test strip holder with the notched end in first and the printing facing up The blue stripe on the top of the strip should no longer be visible when the test strip is correctly and fully inserted Step 6 Prepare the Meter for Sample Application The meter will automatically perform a background blank reading It will display a flashing prompt a blood drop next to a test strip to indicate it is ready to receive a sample The meter will allow 2 minutes for application of the blood sample Step 7 Perform a Fingerstick Incise the underside of the fingertip as highlighted by arrow Wipe away the first drop of blood Apply light pressure to obtain another drop of blood Avoid milking Sy y KA A Note f fresh venous whole blood is to be used perform venipuncture and collect the sample in an anticoaguant free plastic syringe Step 8 Apply Blood Sample to the Test Strip Immediately add a drop of blood to the test strip by touching the hanging blood drop to the test spot Make sure the blood drop is large enough to completely cover the test spot A capillary transfer pipet may also be used to transfer the blood sample from the finger to the test strip
8. C of May 1989 on the approximation of the laws of the member states relating to electromagnetic compatibility Council Directive 1992 31 EEC of 28 April 1992 amending the approximation of the laws of the member states relating to electromagnetic compatibility Safety requirements for electrical equipment for EN61326 1 measurement control and laboratory use EMC requirements Safety requirements for electrical equipment for EN61010 1 2001 measurement control and laboratory use Part 1 General requirements Relevant documentation is kept on file and can be requested at the following address ITC 8 Olsen Avenue Edison NJ 08820 USA Telephone 1 732 548 5700 Fax 1 732 632 9299 WARRANTY AND REPAIR POLICY One 1 year limited warranty ITC warrants the Hgb Pro Professional Hemoglobin Testing System when purchased new to be free of defects in material and workmanship and will repair or replace at the manufacturer s option any Hgb Pro meter that under proper use exhibits such defects Under terms of this warranty the product must be returned properly packaged transportation prepaid with proof of purchase to ITC 8 Olsen Avenue Edison NJ 08820 Attn Service Department This warranty is granted to the original purchaser for one year from the date of the meter manufacture Directive 92 31 EEC IEC 61326 1 2000 11 IEC 61010 1 2000 22 In no event shall ITC be liable for indirect incidental or consequential damages
9. e user can select whether to display time and date in a 12 hour AM PM time clock with mm dd date format United States or in a 24 hour time clock with dd mm date format Europe Note the date format only contains day and month not year 7 a leap year the user must enter the February 29 date to ensure correct stamping of test results Step 1 Press the SET button once the date and time will be displayed Press and hold the SET button again until the time and date flash Step 2 Press the A or V button to select either the 12 hour time with mm dd date format or the 24 hour time with dd mm date format Note Only these settings are available the date and time formats cannot be individually changed Step 3 To enter the current time and date proceed to Enter Time and Date Step 2 below If entering the current time and date is not required then turn the meter off to accept the selected time and date format Once accepted the time and date format will be changed for all stored test results N L SET Button Enter Time and Date The user must enter the current time and date for correct stamping of test results If proceeding from Select Time and Date Format instructions above go directly to Step 2 Otherwise start from Step 1 Step 1 Press and hold the SET button until the time and date flash Press the SET button again Step 2 The hour with AM PM if 12 hour format was selected will flash Press the A or V button t
10. ensuring the test spot is completely filled with blood Follow up action Turn the meter off and turn on again If the code persists contact ITC Technical Service Direct bright sunlight may interfere with the meter s optics Move the meter out of direct bright sunlight to a location with regular room lighting or shade Turn the meter off and turn on again Repeat test with a new test strip Test strip is damaged Remove test strip and turn meter off Turn the meter on again and repeat test with a new test strip Examine the strip before use and do not use if there are tears wrinkles or debris Incorrect sample type Fresh or EDTA anticoagulated blood can be used was used Other sample types such as plasma cannot be used Repeat the test using the correct sample type Test strip is damaged Remove test strip and turn meter off Turn the meter on again and repeat test with a new test strip Examine the strip before use and do not use if there are tears wrinkles or debris Meter optical detector Remove test strip holder and clean the optical requires cleaning detector according to instructions in Routine E4 Maintenance and Cleaning under SERVICE AND MAINTENANCE Meter optical detector is Do not add the blood sample prior to completion of blocked background reading by the meter The meter is ready for sample application when it displays a flashing test strip and blood drop prompt Error Code Source of Error Follow up act
11. er Battery Indicator A low battery indicator is displayed briefly during the meter self check It will be displayed continuously after approximately 800 tests have been performed which indicates the battery is low and needs to be replaced The number of tests actually performed by the meter on the same battery will depend on individual usage patterns When the battery is low the meter may shut off immediately when turned on or during a test A replacement battery should be installed as soon as possible after the low battery indicator is displayed Replacement lithium 3 volt CR2032 batteries can be obtained in most retail stores Battery Replacement Step 1 Lift the test strip holder off the meter E O Sa Step 2 Lift the battery out of the slot Step 3 Hold the new battery at an angle push it into the slot and snap down The positive side of the battery should be facing up 5 minutes of remo f the old battery je time and date ng back int S may be used kg vit to come to room temperature prior Note The new battery must be inserted wi to avoid loss of saved settings Lot Step 4 Replace the test strip holder by s SPECIMEN COLLECTIO Fresh or a ed If an EDTA treat to use EDTA mixed asing Fo he Test Procedure section in the package insert for obtaining fingerstick samples Refer to NCCLS Documents H4 A4 Procedures for the Collection of Diagnostic Blood Specimens
12. error code may be displayed when turning the meter on or performing a test An error code may indicate a problem with blood sample application or test strip or in the test procedure or the meter If an error code appears review the instructions for use and repeat the test with a new test strip The Troubleshooting Guide gives the codes for the most common errors and the appropriate follow up action If an error code persists write down the entire error code and call ITC Technical Service at 1 800 631 5945 1 732 548 5700 Please have the meter serial number test strip lot number and Lot Code ready when you contact Technical Service Troubleshooting Guide Error Code Source of Error Displayed Meter hardware or software error E0 E1 Meter is used in direct bright sunlight Temperature is out Move the meter to a location where ambient room of range temperature is within specification and allow the meter to acclimate Turn the meter off and turn on again Repeat test with a new test strip After the blood sample Once the blood sample is applied to the test strip is applied the test strip the strip should be left in the meter to complete the was removed before the test reading Turn the meter off and turn on again test was completed Repeat test with a new test strip E2 Insufficient blood sample Remove used strip and turn the meter off Turn the was applied meter on again and repeat test with a new test strip
13. g instructions under TEST PROCEDURE Step 2 Before meter shutoff press and hold the W button The test result will flash when the user scrolls through the memory Note The fag can be removed prior to storage only by pressing and holding the Y button again Step 3 Turn meter off to store the test results Store Test Results The meter automatically stores up to 250 test results with a date and time stamp When more than 250 test results are stored the oldest test result is automatically erased Test results are stored in ascending chronological order the first test result displayed Sequence 001 is the most recent one and the last test result displayed up to sequence 250 is the oldest A test result is stored when the meter shuts off either by pressing the O button or automatic shut off after two minutes View Saved Test Results Step 1 Turn the meter on by pressing the button Wait until the meter displays the Lot Code time and date Press the A button to display the test result and its sequence number a flashing MEM will be displayed to the lower left of the test result Release of the button displays the test result with its time and date stamp Step 2 Continue pressing the A or W button to scroll through test results Holding the button will scroll more quickly Step 3 Turn meter off to exit the memory Erase Test Results Test results can be erased in two ways Using the CLA function erase either the most recent
14. gh test results in the memory 2 Display panel e a Displays test strip prompt b current Lot Code c date d time 3 Test Strip Holder e For insertion of test strip Can be removed for cleaning 4 Test Strip 5 Test Spot e Blood sample is applied to the Test Soot membrane 6 Reporting Unit g dL or mmol L CALIBRATION The Hgb Pro meter is self calibrating No additional calibration is required PRECAUTIONS 1 For 7 vitro diagnostic use 2 The Hgb Pro meter is designed for use only with Hgb Pro Hemoglobin test strips 3 Poor blood collection technique and inadequate mixing of EDTA treated samples may affect results 4 As with all diagnostic tests Hgb Pro test results should be evaluated with the specific patient s condition Any results demonstrating inconsistency with the patient s clinical status should be repeated or supplemented with additional test data 5 Review all instructions in this User s Manual for proper technique and procedures for performing tests and using the meter 6 While the test is in progress do not disturb or move the meter or test strip or press any of the meter buttons 7 The Hgb Pro System is designed for storage and operation within a recommended temperature range of 15 C to 30 C Do not expose the meter test strips or patient blood sample to temperature extremes as such exposure could affect performance LIMITATIONS 1 Plasma or serum cannot be used with the Hgb Pro Professiona
15. hen the meter is shut off The meter must be reset shut off restart between each test Test results can be tagged viewed or erased Follow instructions under TAG VIEW AND ERASE TEST RESULTS REPORTABLE RANGE The reportable range for the Hgb Pro Professional Hemoglobin Testing System is from 4 0 g dL to 24 0 g dL Results under 4 0 g dL and over 24 0 g dL will be displayed as Lo and Hi respectively to indicate out of range results QUALITY CONTROL A quality assurance program is recommended to assure the user of reliable performance of the Hgb Pro Professional Hemoglobin Testing System Liquid quality control testing should be performed upon receipt of a new lot of test strips and once per every three months of usage Commercially available control material can be used for this purpose Instructions for use of the commercial controls can be found in the Hgb Pro package insert SET UP OPTIONS Prior to the first use of the Hgb Pro meter the user must enter the following settings e Time and date format 12 hour or 24 hour e Current time and date e Hemoglobin reporting unit g dL or mmol L Entering Settings za Step 1 Lift the test strip holder off the meter Step 2 Turn the meter on by pressing the button Wait until the meter displays the Lot Code time and date The meter can now be customized for time and date format current time and date and hemoglobin reporting units Select Time and Date Format Th
16. ion Displayed Meter optical detector is Check the optical detector to ensure blood or other blocked matter is not present remove the strip holder to view and clean the optical detector as needed See Routine Maintenance and Cleaning under SERVICE AND MAINTENANCE A used test strip was Remove used test strip and turn the meter off Turn inserted into the meter the meter on again and repeat the test with a new test strip E4 cont The test strip was Review instructions under TEST PROCEDURE for inserted incorrectly proper insertion of test strip Remove test strip and turn the meter off Turn the meter on again and per form the test with a new test strip Test strip holder is not Remove test strip holder and install again snapping installed correctly back into place The test strip holder should not be loose or skewed Meter shuts Battery needs to be Obtain and insert replacement battery according to off immediately replaced instructions in Battery Replacement under when turned on SERVICE AND MAINTENANCE or during a test Test Strip is removed The meter will shut off automatically after 4 seconds during a test if a test strip is removed during the performance of a test Perform a new test using a new test strip Product Use Tips e Review all instructions under TEST PROCEDURE to become proficient at using the meter and applying a blood sample to the test strip e Confirm that the Lot Code displayed on the meter matches
17. l Hemoglobin Testing System Use of arterial whole blood has not been evaluated 2 Use of sodium citrate and dried heparin are not recommended INTERFERING SUBSTANCES During clinical studies a number of patients had identified elevated levels of bilirubin cholesterol and triglycerides The interferences of these substances were assessed using the interpretive guidelines of NCCLS Guidance Document EP7 A Interference Testing in Clinical Chemistry Approved Guideline There was no demonstrated interference of these substances on the hemoglobin determination in these analyses No interference was observed at upper threshold concentrations of bilirubin 20 mg dL cholesterol 450 mg dL and triglycerides 750 mg dL in supportive laboratory spiking studies REAGENTS The Hgb Pro hemoglobin test strip consists of a plastic carrier and a membrane preloaded with saponin surfactant and colorant The test strip container is stamped with a lot specific Lot Code and expiration date Note The Lot Code for the lot number of test strips in use must be entered into the meter prior to use see Lot Code Entry under TEST PROCEDURE CAUTION Follow universal precautions and institutional guia blood samples including the use of protective gloves All usel considered potentially infectious handled with policies for disposal of medical waste or handling o Reagent Preparation and Storage 1 Hgb Pro test strips are rea 2 Test strips are stab
18. le at am original container in e only those strips needed for L 100 mm x W 55mm x H 17 mm Less than 100 grams 15 C 30 C lt 80 RH non condensing Lithium 3 volt CR2032 250 test records SERVICE AND MAINTENANCE Routine Maintenance and Cleaning The meter test strip holder should be cleaned after each use to remove any excess blood The strip holder may be lifted off the meter for cleaning Remove any residual blood or other matter on the outside of the test strip holder or the meter by using gauze dampened with an appropriate disinfectant such as a 10 dilution of household bleach equivalent to 0 6 hypochlorite If excess blood is on the optical detector it may be cleaned using a swab moistened with these cleaning solutions Remove any residue and thoroughly dry the test strip holder and the optical detector using a lint free tissue Do not scratch the optical detector surface Do not use strong abrasive or corrosive cleaning solutions as they can damage the meter and the optical detector After cleaning and thoroughly drying replace the test strip holder by snapping into place The test strip holder is a replaceable part that can be ordered through ITC customer service Optical Detector DO NOT immerse the meter in liquids DO NOT use solvents or strong caustic cleaning solutions as they may damage the outer surface of the meter There are no other user serviceable parts on the Hgb Pro hemoglobin met
19. o enter the hour Press the SET button to accept Step 3 The minutes will now flash Press the A or VW button to enter the minutes Press the SET button to accept Step 4 The first date selection will now flash mm or dd Press the A or V button to enter the first date selection Press the SET button to accept Step 5 The second date selection will now flash dd or mm Press the A or V button to enter the second date selection Press the SET button to accept Step 6 Turn the meter off to accept the entered time and date Select Hemoglobin Reporting Unit The reporting unit for hemoglobin results may be selected as either grams deciliter g dL or millimole liter mmol L Step 1 Press the SET button 4 times to display the reporting unit either g dL or mmol L Press and hold the SET button until the unit flashes Release the set button Press the A or W button to select the appropriate reporting unit Step 2 Turn the meter off to accept the selected reporting unit Note Once accepted the reporting unit will be changed for all stored test results When selection of meter settings has been completed replace the test strip holder onto the meter TAG VIEW AND ERASE TEST RESULTS Tag a Test Result A specific test result can be tagged prior to storage Once stored the result will flash when the user scrolls through the meter s memory Tagging is useful for identification of QC test results Step 1 Perform a test followin
20. ts internal circuitry and components during a brief self check The meter is ready when the test strip prompt Lot Code time and date are displayed Note 7o conserve the battery the meter will automatically shut off after 2 minutes of inactivity Lot Code Step 2 Lot Code Entry A specific Lot Code is assigned to each lot of Hgb Pro hemoglobin test strips to ensure optimal lot to lot reproducibility Check the Lot Code displayed on the meter to ensure it matches the Lot Code printed on the test strip container If the Lot Code displayed on the meter does not match the Lot Code printed on the test strip container in use change the Lot Code as follows Step 1 Press and hold the W button until CODE flashes in the upper left hand corner Release the W button Step 2 Press the A or W button so the displayed Lot Code matches the Lot Code printed on the test strip container in use Holding down the button will enable the numbers to scroll faster Release the button when the appropriate number is displayed Step 3 Accept the new Code by pressing the button to turn the meter off Step 4 Turn the meter on again to perform a test Step 3 Prepare for a Fingerstick Make sure the patient s hand is warm and relaxed Use the middle or ring finger Massage the patient s finger from the knuckle up to the tip to stimulate blood flow Clean the sample area with alcohol and wipe dry with a sterile gauze pad Step 4 Prepare
21. we recommend that each clinical site establish its own expected ranges Point of care hemoglobin test systems using whole blood samples are especially useful for rapid patient assessment and determination of further appropriate medical care OPERATION The Hgb Pro meter utilizes optical reflectance at 522 nm for determination of total hemoglobin This wavelength is within the known hemoglobin absorption spectrum 500 600 nm The test strip is inserted into the meter when prompted A background blank reading is automatically determined A drop of whole blood is applied to the test spot on the strip Blood immediately disperses within the membrane contacting the reagent lysing the red blood cells and releasing the hemoglobin The meter s optical detectors automatically measure the change in membrane reflectance The intensity of reflectance is inversely proportional to the hemoglobin concentration The meter calculates and displays the total hemoglobin concentration in grams deciliter g dL or millimole liter mmol L based on a mathematical conversion The test result will be displayed in less than 30 seconds p 6 Reporting Unit 1 He a Test Strip Prompt FEATURES Display Panel nr eee b Lot Code 5 Test spot 4 Test strip 1 Button Panel e Power button Turns the meter on and off e Up A Down Y buttons For use in entering Lot Code and meter settings tagging a result and scrolling throu
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