User Manual
Contents
1. LACTATE PLUS nstructions for Use Manual L ktete www laktate com Quick Reference Guide 1 Intended USE iisi ebrei ee Prayer 4 iS innere ECCE 7 Warnings Cautions and Notes 8 Introdu IOM ERIT 9 The Lactate Plus Meter 9 OV ORI OW DM 13 Meter Supplies Transport Case 14 Environmental edi aiurita 15 SOLU vi ce M 16 Set the Esser dori 16 Set Date Format 19 Beeper On or Off 22 heri t 23 Testing Blood and Quality Control Solutions 24 Testing a Quality Control Solution 25 1284 Testing a Blood Sample 27 Data REVIEW E 32 Data Review 32 Manually Reviewing Stored Test or Control Results 32 Battery Replacement sus ceca etes 34 Cleaning and Gare steer oett geo ctu tee anne 35 Error MESSAGES dete epp cs 36 CODES RS 36 fere 37 Specifications DE 37 Performance Characteristics 39 oil PED 40 Precision EET 41 Instructional 43 Marano adt aa netted emu Ont an 47 o 128 Quick Reference Guide 1 Prepare the lancet a Simply twist off the lancet cap Hold the lancet body and twist off the lancet cap until you feel it separate from the device b Do not pull just twi2. curate meter performance THE FOREGOING OBLIGATIONS ARE IN LIEU OF ALL OTHER OBLIGA TIONS AND LIABILITIES INCLUDING NEGLIGENCE AND ALL WARRAN TIES OF MERCHANTABILITY OR OTHERWISE EXPRESSED OR IMPLIED IN FACT BY LAW AND STATE OUR ENTIRE AND EXCLUSIVE LIABILITY AND BUYER S EXCLUSIVE REMEDY FOR ANY CLAIM OF DAMAGES IN CONNECTION WITH THE SALE OR FURNISHING OF GOODS OR PARTS THEIR DESIGN SUITABILITY FOR USE INSTALLATION OR OPERATION NOVA BIOMEDICAL WILL IN NO EVENT BE LIABLE FOR ANY SPECIAL OR CONSEQUENTIAL DAMAGES WHATSOEVER AND OUR LIABILITY UNDER NO CIRCUMSTANCES WILL EXCEED THE CONTRACT PRICE FOR THE GOODS FOR WHICH THE LIABILITY IS CLAIMED nova o FE LACTATE PLUS NOVA S LACTATE PLUS gal Nova Biomedical Telephone 1 800 350 5024 200 Prospect Street 1 781 894 0800 Waltham MA 02454 9141 Fax 1 781 894 5915 U S A Web www novalactate com U S Patent Nos 6 258 229 6 287 451 and 6 837 976 Additional Foreign Patents apply Made in the USA by Nova Biomedical Corporation Copyright 2006 Nova Biomedical Corporation REF 41293B 01 2007 biomedical
3. nova Testing Blood and Quality Control Solutions NOTE Before running a blood or quality control test check that the expiration date of the test strips and control solution has not elapsed See product insert sheets for details The control solution test results should fall within the range of results printed on the label of the control solution You should run a control solution test e Before using your Nova Lactate Plus Meter for the first time and at least once a week thereafter e Each time you open a new box of Nova Lactate Test Strips fyou leave the Nova Lactate Test Strip vial cap open for an extended period of time f you drop your Nova Lactate Plus Meter If your results are higher or lower than expected User should follow the appropriate Federal State and Local Guide Lines concerning the running of external quality controls NOVA Testing Blood and Quality Control Solutions Testing a Quality Control Solution 1 Grasp a test strip with logo side up and gold side down Then insert the gold end into the meter See Meter figure 2 Identify the sample as a control use the SEARCH WE button to find the desired control level CrL 1 or CrL 2 3 Shake the control solution well before each use Discard the first drop 4 Place a drop of control solution from the bottle at the end of the test strip until the solu tion is drawn into the well of the test strip NOTE The on screen Control Drop flash
4. Vol 39 pp 2312 2314 Sprules S D Hart J P Wring S A and Pittson R 1995 A Re agentless Disposable Biosensor for Lactic Acid based on a Screen printed Carbon Electrode Containing Meldola s Blue and Coated with Lactate Dehydrogenase NAD and Cellulose Acetate Anal Chim Acta Vol 304 pp 17 24 biomedical Appendix Instructional Notes 1 Inserting a test strip overrides all other modes 2 There is no All segments Screen in Upload mode 3 When in Upload mode no other meter functions are avail able and there is no response by meter to button presses 4 The meter times out in 5 minutes in Upload mode 5 Inserting a test strip overrides any mode except Upload mode 6 If in setup mode when the test strip is inserted the me ter saves all values entered up to that point and immedi ately switches to test mode Upon exiting test mode the meter screen goes blank and does not return to setup mode nova FE LACTATE PLUS T 10 11 Appendix If in Data Review mode when the test strip is inserted the meter immediately switches to test mode Upon exit ing test mode the meter screen goes blank and does not return to Data Review mode Battery low icon is displayed in every mode except setup Once battery level goes below the threshold that trig gers the low battery warning it continues to give the warning until the meter becomes unusable due to low battery A failed control solution does NO
5. 1 Remove the back battery cover on the meter 2 Remove the battery and re place with a new one with the side facing up 3 Replace the battery cover 4 Goto set up and reset the time and date Low Battery Replacing Battery o NOVA Basic Upkeep Cleaning and Care If necessary clean the Lactate Plus Meter with a clean cloth dampened with water Keep liquids from entering the test strip port or the Search Enter and Mode buttons FS LACTATE PLUS CAUTION Do Not attempt to open the Lactate Plus Meter to make any repairs Your warranty and all claims will be void Only Nova Biomedical authorized service personnel can repair the meter Call Nova Biomedical or an autho rized dealer if the meter needs to be repaired or checked nova Error Messages Codes Code Alerts E 0 Software error detected E 1 Hardware error detected E 2 Meter temperature is outside of the range for testing E 3 Defective or previously used test strip is detected E 4 A short sample control solution or blood is identified LO or ftest results are outside of the HI measuring range of the meter Battery level is low Action Perform the test again If you get the same error call Nova Technical Support Perform the test again If you get the same error call Nova Technical Support Move the meter to an area where the temperature is acceptable 41 113 F allow meter to adjust to the temperature Repeat testing Repeat test with
6. a new test strip Repeat test with a new test strip and adequate sample Repeat test If you get the same result consult your physician Replace the battery biomedical Appendix Specifications Tests Measured Blood Lactate Lactate Methodology Lactate oxidase biosensor Lactate Test Results mmol l Plasma values Sample Type Whole blood Lactate Test Range 0 3 to 25 0 mmol l Test Time 13 seconds Test Strip Volumes 0 6 ul Battery Life nominal 600 Tests Data Output Port Serial Data Output Cable optional biomedical FE LACTATE PLUS Appendix Operating Ranges Temperature Lactate 41 to 113 F 5 to 45 C Humidity 10 to 90 relative humidity Weight 2 65 oz 75 g Size 3 6x2 3x0 9 in 91 4x58 4x22 9 mm On board data storage files 1 common file for 20 tests 9 additional user files for 10 tests each 2 control files 10 tests each yoa Appendix Accessories Vial of Test Strips 25 REF 40813 Lactate Plus Control Solution Level 1 REF 40815 Lactate Plus Control Solution Level 2 REF 40814 PC Data Communication upload Cable REF 41235 Soft Carrying Case 41266 Battery DL2450 REF 41221 Performance Characteristics The test result range for Nova Lactate Plus Meter is 0 3 to 25 0 mmol l for Lactate biomedical FE LACTATE PLUS Appendix Accuracy Accuracy of the Lactate Plus Meter system was assayed at clinical sites by comparing lactate results obtained by Lactate Plus Mete
7. e test strips lancets and alcohol swabs must be disposed of in accordance to local regulations to avoid risk to anyone WARNING Please keep the Lactate Plus Meter and its accessories out of reach of small children to prevent ac cidents through improper handling and to avoid the risk of small parts being swallowed nova d F LACTATE PLUS Introduction Lactate Plus LAC 5 LCD Display Strip Select Button Mode Button Search Button Lactate Plus Meter pora Introduction The Lactate Plus Meter is a hand held testing device that measures lactate Lac in whole blood The test strip is touched to a drop of blood to initiate the test process Asimple one step process provides a blood lactate result Test result is available in 13 seconds There is memory for one common user s set of test results 20 Nine specific users set of test results 10 each Two sets of Quality Control QC results 10 each e The unit is powered by a battery that can perform for approximately 600 tests nova o FE LACTATE PLUS User Profile Number Quality Control Indicator Low Battery Indicator Blood or Control Drop Indicator Introduction Beeper ON Indicator L JL Date Day Hour Minute User Profile ICON Lactate Test Result in mmol l Test Result in Memory Indicator Average Test Result AM or PM Indicator Lactate Plus Meter Screen biomedical Introduction C
8. repeated measure ments are being made on the same subject Reference Graeme Maw Simon Locke David Cowley and Patricia Witt 2000 Blood Sampling and Sampling Techniques In Physiological Tests for Elite Athletes ed Christopher John Gore PhD 91 92 Champaign IL Human Kinetics NOVA Testing Blood and Quality Control Solutions Profile Number Lactate Result Date Lactate Plus Meter with Display Results 104 FE LACTATE PLUS Data Review Data Review NOTE If a test strip is inserted while in the Data Review mode the meter immediately switches to test mode If you then exit the test mode the meter screen goes blank the meter does not return to the Data Review mode Manually Reviewing Stored Test or Control Results 1 With the meter off press the MODE 4 button for 2 seconds To turn the meter off press the MODE 4 button for 1 5 seconds 2 The most recent test result in the last user s profile is displayed 3 Use the SEARCH button to scroll back through the user s test results yoa 4 Press the MODE wv button to advance to the user profile PO to P9 or control level 1 or 2 that you want to review 5 Press the SEARCH SE button to review the test results for the selected user or the control level FE LACTATE PLUS nova e Basic Upkeep Battery Replacement The meter is powered by a single 3V coin cell battery 2450 Replace the battery as follows
9. AUTION The meter should be handled with care Dropping rough handling etc may damage the meter Also protect the meter from moisture prolonged direct sunlight and high temperatures FE LACTATE PLUS Overview To perform a test the operator simply inserts a test strip places a drop of sample onto the test strip and obtains a lactate test result in 13 seconds The test result is automati cally stored into the meter s memory The operator can recall delete and review test data resident in the meter including the average for each control and user profile s results nova o Introduction Meter Supplies Transport Case The Nova Lactate Plus Meter 40828 comes in a soft carry ing case that includes 1 Lactate Plus Meter with Battery 2 Instructions for Use Manual 3 Quick Reference Guide See Page 39 for a listing of supplies and accessories o yoa Introduction Environmental The storage temperature range for the Meter 13 F to 115 F 25 C to 46 C The storage temperature range for the Test Strips and Control Solutions room temperature 15 30 C 59 86 F The meter operational temperature range for Lactate 41 F to 113 F 5 C to 45 C The relative humidity range 10 to 90 non condensing F LACTATE PLUS nova o Setup Set the Time Press the MODE button for longer than 3 seconds The meter if in Sleep Mode wakes up and enters the SETUP Mode View the hour flashing format eith
10. T lock the user out of the meter Beeps that are not disabled when BEEP is set to OFF The quick triple beep warning for HI or LO errors and Error codes EO to E4 NOVA Appendix 12 The Meter responses to the pressing and the holding of keys SEARCH key The Meter responds immediately after the SEARCH key is pressed In cases where the SEARCH key moves forward through a series of stored test result screens or increments a value hold down the SEARCH key to speed up screen change process MODE key When the MODE key is pressed 1 5 seconds to advance to the next function the meter advances to next screen immediately when key pressed While meter is in sleep mode OFF pressing the MODE button 1 5 seconds wakes up the meter and enters data review mode nova FE LACTATE PLUS Appendix While meter is in sleep mode OFF pressing the MODE button gt 3 0 seconds wakes up the meter and enters setup mode While meter is awake ON pressing the MODE button gt 1 5 seconds manually turns off the meter sleep mode While meter is in DATA REVIEW pressing the MODE 1 5 seconds puts into Avg screen of the next user 13 With No Activity Time out will occur in 1 Minute for all screens 4 Minutes during analysis 2 Minutes after the completion of analysis 5 Minutes when upload connector inserted o NOVA Appendix Warranty Subject to the exclusions and upon the conditions specified below Nova Bio med
11. er 12 Hr or 24 Hr by pressing the SEARCH TS button to toggle between the 2 time format options available Press the SELECT button to choose the Hour For mat The meter displays the current time or the default time 12 00 AM or 0 00 hours Press the SEARCH button to progress from 1AM to 12PM for 12 Hr Clock or 0 to 23 for 24 Hr Clock The hour digits will be flashing until selected NOVA Setup Press the SELECT button to select the displayed Hour choice Next set the minutes Press the SEARCH button to progress from 00 to 59 minutes The minute digits will am flashing until selected Press the SELECT button to select the displayed Minutes choice nova D F LACTATE PLUS Setup Hej He He AN an Hn 2006 120054 12590 1a Select 12 Hour then select 2 Select minutes hour with AM PM He He He AN m n 2300 200 J 1259 1b Or Select 24 Hour then select hour o NOVA Setup Set Date Format After the time has been set up set date format is next The display is 12 31 2004 or 31 12 2004 You can choose to have the date as DD MM or MM DD These digits will be flashing until selected Press the SEARCH button to toggle between DD MM or MM DD Press the SELECT button to select the displayed Date Format choice Press the SEARCH WE button to display years from 2004 to 2099 The year number
12. es on and off repeatedly until sufficient control solution has been added to the test strip nova 25 u 2 n Uu 4 a Testing Blood and Quality Control Solutions ALactate quality control test result is available on screen in 13 seconds The result is automatically stored into memory If this result is not needed press the SELECT but ton for 2 seconds to go to dELEtE flashes mode while the test strip is still in place Press SELECT again to confirm deletion or press SEARCH to stop deletion and exit the delete mode NOVA Testing Blood and Quality Control Solutions Testing a Blood Sample NOTE The hands should be warm and relaxed Obtain blood sample from a finger 1 Check that the expiration date of the test strips has not elapsed 2 Wash hands with water then dry thoroughly Alternatively use alcohol pads to clean area 3 times dry thoroughly after each cleaning 3 Grasp a test strip Insert the gold end into the meter 4 Select a profile number use the SEARCH 2 button to find the Profile Number PO to P9 NOTE Cleaning of the puncture site is important Sweat left on the fingers may cause falsely high lactate test results nova e F LACTATE PLUS Testing Blood and Quality Control Solutions 5 Holding hand downward massage finger with thumb toward tip to stimulate blood flow 6 Use the lancet to puncture the finger 7 Wipe off the first dro
13. ical or the authorized Nova Biomedical distributor warrants that he will correct free of all charges including labor either by repair or at his election by replacement any part of an instrument which fails within one 1 year from date of shipment because of defective material or workmanship This warranty does not include normal wear from use and excludes A Service or parts required for repair of damage caused by accident neglect misuse altering the Nova equipment unfavorable environmental conditions electric current fluctuations work performed by any party other than an authorized Nova representative or any force of nature B Work which in the sole and exclusive opinion of Nova is impractical to perform because of location alterations in the Nova equipment or connection of the Nova equipment to any other device C Specification changes D Service required to parts in the system contacted or otherwise affected by expendables or reagents not manufactured by Nova which cause shortened life erratic behavior damage or poor analytical performance E Service required because of problems which in the sole and exclusive opinion of Nova have been caused by any unauthorized third party or F Instrument refurbishing for cosmetic nova o FE LACTATE PLUS Appendix purposes All parts replaced under the original warranty will be warranted only until the end of the original instrument warranty All requests for war ranty replaceme
14. is manual and accompanying product inserts com pletely before performing blood measurements Intended Use The Lactate Plus Meter System is intended for use by healthcare professionals to quantitatively measure lactate in whole blood to evaluate physical performance and or to establish a proper intensity of exercise for athletes The device system is for in vitro diagnostic use only nova d F LACTATE PLUS NOVA Symbols The following are symbols that are used in this manual on insert sheets and on the Lactate Plus Meter In vitro diagnostic medical IVD g REF device Catalog number Fulfills requirements of Temperature limitation Directive 98 79 EC IVDD eu Biological risk biomedical Caution consult accompanying documents Upper Limit of Temperature Consult instructions for use g l Manufactured by LACTATE PLUS E Warnings Cautions and Notes NOTES provide important or helpful operating information CAUTIONS provide information that is important for instru ment protection WARNINGS provide information that is important for user protection or about risk for inaccurate results NOVA Introduction The Lactate Plus Meter WARNING Blood samples and blood products are e potential sources of hepatitis and other infectious agents Handle all blood products with care Wear gloves when performing measurements on another person Items that are used to measure lactate i
15. nt must be received by Nova or their authorized distributor within thirty 30 days after the component failure Nova Biomedical reserves the right to change alter modify or improve any of its instruments without any obligation to make corresponding changes to any instrument previously Sold or shipped All service will be rendered during Nova s principal hours of operation Contact Nova for specific information The following exceptions apply Consumable items including the test strips and quality control solutions are warranted to be free of defects at time of initial use The item must be placed into service prior to the expiration date printed on the packaging All defects must be promptly reported to Nova Biomedi cal in writing Freight is paid by the customer This warranty is invalid under the following conditions 1 The date printed on the package label has been exceeded 2 Non Nova Biomedical reagents or controls are used as follows Nova Biomedical will not be responsible for any warranty on Lactate nova biomedical Plus Meter if used in conjunction with and are adversely affected by reagents controls or other material not manufactured by Nova but which contact or affect such parts Reagent or quality control solution formulations not manufactured by Nova Biomedical may contain acids concentrated salt solutions and artificial preservatives that have been shown to cause problems such as erratic analytical results or inac
16. p with a clean tissue The first drop may be contaminated 8 Squeeze the finger to form a second drop of blood To avoid collection of interstitial fluid as well as blood do not squeeze vigorously 9 When the second blood drop appears touch the end of the test strip to the blood drop until the well of test strip is full and the meter beeps NOTE The on screen Blood Drop flashes on and off repeatedly until sufficient blood has been added to the test strip NOVA Testing Blood and Quality Control Solutions 10 If subject has to immediately return to exercise and puncture site is still bleeding apply light pressure with a cotton pad or tissue until the bleeding stops or cover with a bandage 11 The Lactate result is available on screen in 13 seconds 12 The result is automatically stored into memory 13 If the result is not needed press the SELECT vut ton for 2 seconds to go to dELEtE flashes mode while the test strip is still in place 14 Press SELECT again to confirm deletion or press SEARCH WEB to stop deletion and exit the delete mode nova o FE LACTATE PLUS Testing Blood and Quality Control Solutions WARNING Once a disposable item i e lancet test strip alcohol swab etc has been used it is consid ered contaminated Dispose of all contaminated mate rials in accordance with local regulations Equipment such as lancets and tissues must be used only once and then disposed of even when
17. r vs YSI Reference method from subjects at clinical sites Blood lactate measurements obtained from Nova Lactate Plus Meter were compared with the same subjects results from the YSI a laboratory reference method The latter results were plasma de rived values from a blood sample measured on a YSI 2300 Stat Plus Analyzer Number of Samples 210 Slope 0 968 Correlation Coefficient r 0 997 yintercept 0 165 mmol l e Range tested 0 5 12 4 mmol l These results indicate that Nova Lactate Plus Meter compared well with the laboratory reference method o NOVA Appendix Precision Precision of Nova Lactate Plus Meter was measured with both ve nous blood samples and control solution in laboratory The results are shown below Lactate Level r lzl l4l5 Lactate Mean mmol l 46 6 5 10 8 18 1 2 1 20 measurements nova Appendix References 1 Clark L C Jr Noyes L K Grooms T A Moore M S 1984 Rapid Micromeasurement of Lactate in Whole Blood Critical Care Medicine Vol 12 pp 481 464 Hirano K Yamato N Kunimoto K and Ohwa M 2001 Novel Electron Transfer mediators Based on Dichloroindophenol Derivatives for Lactate Oxidase Journal Electroanalytical Chemistry Vol 510 pp 149 152 Shimoje N Naka K Uenoyama H Hamamoto K Yoshioka K and Kiyoshi O 1993 Electrochemical Assay System with Single use Electrode Strip for Measuring Lactate in Whole Blood Clinical Chem istry
18. s will be flashing Displays current date time or default 1 01 2004 Press the SELECT button to select the displayed Year choice nova o F LACTATE PLUS Setup The date is displayed as selected in the date format either DD MM or MM DD Pressthe SEARCH WS button to progress through the 12 months 1 to 12 The 2 month numbers will be flashing Press the SELECT button to select the displayed Month choice Lastly press the SEARCH TS buttonto progress through the days of a month 1 to 31 The 2 day numbers will be flashing Press the SELECT button to select the displayed Day choice NOVA 123 200 3 L 22004 3 Select Date format MM DD or DD MM m m piu piu Hi 200 3 10 200 5 Select Month Setup nova dr r 631 2094 t3 2048 4 Select Year with Search button leat 2004 3 10 2004 6 Select Day FE LACTATE PLUS Setup Beeper On or Off Next is the Beeper on or off Press the SEARCH button to toggle between ON and OFF flashing Press the SELECT button to select the displayed ON or OFF choice 4 OFF 7 Select Beeper ON or Beeper OFF NOVA Setup End of Setup The screen displays END Press the MODE button for 1 5 seconds to save the setup configuration The meter will power down The new settings will be ap plied once the meter is powered back up FS LACTATE PLUS End SEEU 8 End of Setup
19. st the lancet cap Dispose of the cap in a suitable container NOTE This device is single use The needle retracts immediately after sampling This leaves the device safe for immediate disposal into a sharps container biomedical TAT PLUS LAC Quick Reference Guide 2 Insert a Test Strip Insert Test Strip Automatic System Check begins User Profile Number displays use Search key to select fie gt m g SEARCH SELECT MODE yoa Quick Reference Guide 3 Prepare the Puncture Site c The best puncture sites are on the middle or ring finger Clean the finger tip thoroughly with soap and water Then dry thoroughly d Place the auto Lancet against the pad of the finger press the release button remove the device from the finger e Wait a few seconds for a blood drop to form Wipe off the first drop with a clean tissue Squeeze the finger to form a second drop of blood Do not squeeze vigorously biomedical LACTATE PLUS Quick Reference Guide 4 Add Blood to Test Strip When the second blood drop appears touch the end of the test strip to the blood drop until the well of test strip is full and the meter beeps The on screen Blood Drop flashes on and off repeatedly until sufficient blood has been added to the test strip The Lactate result is available on screen in 13 seconds o NOVA Nova Biomedical recommends that the user of this device read th
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