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POCT Precision Xceed Pro Operator`s Manual (mmol per L)

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2. c Precision Xceed Pro Blood Glucose and Q Ketone Monitoring System Operator s Manual EC REP Abbott Diabetes Care Ltd Abbott Diabetes Care Inc Range Road 1360 South Loop Road Witney Oxon Alameda CA 94502 USA 0X29 QYL UK Precision Xceed Pro TruelD TrueMeasure TrueAccess PrecisionWeb Precision MediSense Optium and Precision PCx are trademarks of the Abbott Group of Companies in various jurisdictions Other trademarks are the property of their respective owners O 2009 Abbott ART17026 Rev B 03 09 x Precision XceedPro C Abbott Table of Contents This Operator s Manual provides basic information about the Precision Xceed Pro System It is organized into three sections First the overview in Chapter 1 describes the components of the Precision Xceed Pro System and the physical features of the monitor Next Chapters 2 through 8 give step by step procedures to operate the monitor Finally Chapters 9 through 12 provide additional information to help care for the monitor OVEFVIEW AAA O In RR 1 A RU c 1 1 Tuc True Meiste and A inici 1 1 en A EE UE E O 1 2 d ras Je itetenciuio 1 2 DUSEE DIC OPHDODE DES A o o A etel Br Devo dt DERE NE AT E A MENS M UEU MUS 28 Using the MONITO miii Ra 2 DAA clu ae 2 1 DE tt 2 1 A os 2 2 bcd P
3. After a data upload error has occurred the monitor will display a warning each time it is turned on The monitor may still be used for testing by pressing 1 to Continue Once the monitor has successfully been docked the warning will disappear Last upload Incomplete Kedock meter 1 Continue uestions Refer to Page 10 10 for Technical Support Instructions Chapter 9 Data Upload O Q Docking Station The Precision Xceed Pro System offers an optional docking station that provides a means for hands free automatic data transfer upload download between the Precision Xceed Pro Monitor and a PC running the data management application software Set up the docking station outside patient vicinity The docking station has a hinged base that allows it to sit on a desktop or to be mounted to a wall using the included mounting plate The Precision Xceed Pro Monitor is compatible with older Abbott docking stations that have LED lights lit with an optional AC Adapter The following LED information applies only to older docking stations The green LED indicates that the docking station is connected to a power E supply Abbott The yellow LED steady indicates that the monitor has been properly placed into the docking station The yellow LED flashing indicates data transfer upload download is in process Ihe AC Adapter is not required If the AC adapter is not used data transfer will still occur but the LEDs will not light up
4. Puerto Rico Abbott Laboratories Abbott Diabetes Care San Juan Puerto Rico USA Tel 1 787 750 5454 USA Abbott Diabetes Care Alameda CA USA Tel 1 877 529 7185 Chapter 10 Troubleshooting 11 Maintenance Cleaning the Exterior Surface Replacing the Port Protector Battery Life Replacing the Batteries Maintenance The Precision Xceed Pro Monitor requires little routine maintenance During testing the sample remains outside the monitor which significantly reduces the possibility of contamination Follow your facilitys procedures for maintenance and inspection of the system This chapter describes the maintenance tasks for the monitor e Cleaning the exterior surface of the monitor e Replacing the port protector e Replacing the batteries Cleaning the Exterior Surface Cleaning the exterior surface of the Precision Xceed Pro Monitor daily is recommended Follow your facility s policies and procedures for infection control which may require more frequent cleaning A IMPORTANT It is recommended to clean after each patient for infection control The monitor needs to be cleaned only with a damp cloth or a sponge and a mild detergent Acceptable cleaning solutions include alcohol and ammonia based cleaners Recommended solutions are Sani Cloth HB Sani Cloth Plus and Super Sani Cloth Bleach or hydrogen peroxide based cleaners will fade the monitor keypad Hype Wipe Dispatch and Virox 5 wi
5. 2 Press 1 to select Patient Test The monitor starts in Test Mode The Menu button will toggle the monitor to 2SB U6 Of 9 02 AM Menu Mode m 1 Patient Test 2 Control Test Scan or Enter 3 Press Scan to scan the Operator ID bar While the Operator ID may be up to 30 Operator ID code or manually enter the Operator ID digits not all digits will fit on the display P via the keypad then press Enter The monitor may also be set to truncate ignore leading trailing and or selected A digits ofthe bar code Scan ar Enter 4 Press Scan to scan the Patient ID bar code While the Patient ID may be up to 30 or manually enter the Patient ID via the digits not all digits will fit on the display Patient 1D keypad if enabled The monitor may also be set to truncate ignore selected digits of the bar code PATIENT 5 Confirm the Patient ID if prompted Confirm You may see one of the following four Patient 10 screens Re enter the ID using the keypad If you enter the ID manually you may Euren wm cde cmm be required to enter it a second time to T i E N T ensure it is correct Questions Refer to Page 10 10 for Technical Support Instructions Chapter 3 Patient Test eo Q What You See on the Display Patient ID z00e1l9395 5mith John 23 01 65 A 1 ReEnter IL Contirm Patient ID 0206139533 5mith John Q 22 01 65 A Confirm Year of Birth Patient ID Patient Data Hot Found 1 ReEnter ID
6. 800 189 564 Denmark Abbott Laboratories A S Abbott Diabetes Care Gentofte Danmark Tel 45 3977 0190 Finland Abbott Oy Abbott Diabetes Care Espoo Finland Tel 0800 555 500 France Abbott France Abbott Diabetes Care Rungis Cedex France Tel 0800 10 11 56 Germany Abbott GmbH amp CO KG Abbott Diabetes Care Wiesbaden Germany Tel 0800 519 9519 Greece Abbott Diabetes Care Athens Greece Athens Tel 30 210 998 5220 Thessaloniki Tel 30 231 047 2947 Ireland Abbott Diabetes Care Dublin Ireland Tel 1 800 776 633 Italy Abbott Diabetes Care Italia Roma Italia Tel 800 334 216 Netherlands Abbott B V Abbott Diabetes Care Amersfoort Nederlands Tel 0800 022 8828 Norway Abbott Norge as Abbott Diabetes Care Fomebu Norway Tel 800 87 100 Poland Abbott Laboratories Poland Sp z 0 0 Abbott Diabetes Care Warszawa Poland Tel 0 801 379 799 Portugal Abbott Laborat rios Lda Abbott Diabetes Care Amadora Portugal Tel 800 200 891 Spain Abbott Cientifica S A Madrid Spain Tel 900 300 119 Sweden Abbott Scandinavia AB Abbott Diabetes Care Solna Sweden Tel 020 190 11 11 Switzerland ABBOTT AG Abbott Diabetes Care Baar Switzerland Tel 041 768 44 47 United Kingdom Abbott Diabetes Care Maidenhead Berkshire UK Tel 0500 467 466 Chapter 10 Troubleshooting D Q uestions Refer to Page 10 10 for Technical Support Instructions
7. Explanation The bar code just scanned was not accepted Possible reasons are e The red scanner beam did not pass across all the bars of the code e The bar code was damaged or poorly printed e The bar code was not of the type specified for this ID or lot number The bar code just scanned is from a foil packet of test strips that has expired The ID or lot number just scanned or entered is too long or too short according to format defined during the setup of this monitor The ID or lot number just scanned or entered is not on the list of acceptable ID s or lot numbers defined for this monitor The menu item 2 Continue appear only if this option is set to Warn The strip inserted is a Glucose strip while the monitor was expecting a Ketone strip or vice versa How To Respond 1 Rescan the bar code or manually enter the ID or lot number 2 Notify the system administrator The problem may be the printing of the bar code or the setup 1 Discard the expired test strips 2 Repeat the scan with a new unexpired foil packet of test strips 1 Verify and re enter the ID or lot number using the bar code scanner or keypad 2 If the problem persists notify the system administrator 1 Press 1 to ReEnter the ID or lot number using the bar code scanner or keypad Or Press 2 to Continue testing 2 If the problem persists notify the system administrator Press 1 to replace with the expected te
8. Note The following section illustrates some common settings Depending on your institution s specific settings some screens will display differently or not at all If the monitor does not display the screens shown please refer to Chapter 10 Troubleshooting What You See on the Display What You Do Comments 1 Press 4 to select Control Data The monitor shows the result of the most Data Revie recent control test 1 Patient bu perIL Patient bu Patll All Patient Data 4 Contral Data a Fraficiencu Data E Linearity Data 2 You can select one of the following The number that appears to the right of Lou options 1 Previous and 2 Next on the monitor Press 1 Previous indicates the number of tests available for PRESS Press 2 Next review The display also shows the acceptable Glucose When finished reviewing the data range for this test and 76 06 07 10 06 HM you can Comment Code Number in box 1 Previous 1 Press Clear to return to the Level Low Mid High 2 NHast Data Review screen Range if numeric Press Menu to return to the Test Type Glucose or Ketone Menu Mode menu Date and Time of test Press On Off to turn off the monitor Operator ID 0 prompt Note that test date and time alternates with Operator ID uestions Refer to Page 10 10 for Technical Support Instructions Chapter 5 Data Review e Q Data Review for Proficiency Data The monitor stores the last 20 proficiency test results Please refer to the begin
9. Press the Enter button after entering data on the keypad to proceed to the next screen Audible Indicator not visible The monitor has an audible indicator that can be turned on or off This indicator emits two tones a high pitched tone to indicate success and a low pitched tone to indicate a problem If enabled the monitor will beep to indicate the following actions e The operator has successfully scanned a bar code e The monitor has detected an adequate sample and is starting test analysis e The monitor is nearing completion of test analysis 3 beeps with final countdown e The monitor has displayed the test result e An error has occurred see Chapter 10 for troubleshooting information e The monitor will automatically shut off in thirty seconds 2 beeps e The operator has pressed an unexpected button e The operator has pressed the On Off button Data Port The Data Port is located at the bottom of the monitor This port enables the monitor to automatically transfer the data through a cable or docking station to the data management system Battery Compartment The monitor holds two AA batteries to power the monitor To prolong the battery life of the monitor the monitor should be turned off when not in use Data is not affected if batteries are removed Port Protector The port protector covers the test strip port The port protector is designed to minimize the possibility of liquid entering the monitor through the s
10. Underneath this is the window for the bar code scanner On the back of the monitor is the battery cover Chapter 11 also provides instructions for changing the batteries Just below the battery compartment is a label with the unique serial number of the monitor On the side of the monitor is the monitor identification space This untextured area 22 mm wide by 11 mm high 0 875 inches wide by 0 483 inches high provides a space in which to apply a facility specific location label At the bottom is the data port for connecting the monitor to a data upload cable or docking station Chapter 9 provides information on uploading data to a data management system Battery Compartment Serial Number Each Precision Xceed Pro Monitor is shipped with this Operators Manual on CD Rom one Port Protector installed and two AA Batteries A IMPORTANT Do not put blood orforeign objects into the test strip port of the monitor A IMPORTANT Observe caution when using around children Small parts may constitute a choking hazard uestions Refer to Page 10 10 for Technical Support Instructions Chapter 1 Overview o Q Test Strips Precision Xceed Pro Test Strips offer the latest advancements in biosensor technology The test strips work by first inserting the contact bars into the monitor Then the sample is applied to the target area covering both the working electrode and the reference electrode This area is coated with active ingredients that r
11. 1 Heut 4 Press 1 Next to continue to the Securitu Security Operator ID Not Certified Ketone screen AC Interval Allow Test 24 hours Heut Securit 5 Press 1 Next to continue to the Security Strip Lot Not on List screen Operator ID Hat Certified Allow Test 1 Hext c 5 6 Press 1 Next to continue to the RIEL Security Patient Data Not Confirmed Strip Lot screen Hat an List Allow Test 1 Hext Chapter 8 Review Setup eo Questions Refer to Page 10 10 for Technical Support Instructions Review Test Setup for Security Ay Note This section illustrates some representative settings Ifthe monitor does not display these screens please refer to Chapter 10 Troubleshooting What You See on the Display What You Do Comments Securit 7 Press 1 Next to continue to the z Security Confirm Patient Data screen Patient Data Hat Confirmed Allow Test 1 Hext E 8 Press 1 Next to return to the ecurituy Test Setup menu Confirm Patient Data Tear of Birth 1 Mext Questions Refer to Page 10 10 for Technical Support Instructions Chapter 8 Review Setup System Status Ay Note This section illustrates some representative settings Ifthe monitor does not display these screens please refer to Chapter 10 Troubleshooting What You See on the Display What You Do Comments 1 Press On Off to turn on the monitor The Abbott logo screen will appear in black for a few seconds and then will appear in gray to ensur
12. 4 times Remove the cap of the control solution bottle and wipe the nozzle with a clean gauze or tissue Apply a small drop of solution to the test strip target area allowing the target area to fill completely Wipe the nozzle of the control solution bottle before replacing the cap 3 Wait for the monitor to analyze the sample and display the test result 4 Note the test result and whether it falls within the acceptable range If required scan or manually enter the comment code and press Enter If there is no prompt to enter a comment code skip down to step 5 5 You may select one of the following Press 1 Next Level Press 2 Repeat Test Press Menu to return to the Menu Mode menu Press On Off to turn off the monitor Remove the test strip from the monitor and discard it when finished testing Follow your facility s biohazard disposal policy uestions Refer to Page 10 10 for Technical Support Instructions Comments Prior to inserting the test strip ensure that the port protector is installed and that it is clean and dry Replace if necessary The display will alternate between Insert Strip and Ketone When sufficient sample has been applied the monitor beeps displays Sample Accepted and automatically starts the test For a detailed description of the test strip target area refer to the Test Strips section of Chapter 1 The monitor counts down then displays the test result If an error is
13. ART12824 Rev A 03 07 Laser hazard This product complies with 21 CFR 1040 10 and IEC 60825 1 2001 CDRH Class II IEC Class 2 Laser Product gt Caution Use of controls adjustments or performance of procedures other than those specified herein may result in hazardous laser light exposure This label is permanently Class 2 laser scanners use a low power visible light diode As with any very bright ici al light source such as the sun the user should avoid staring directly into the light beam oir Momentary exposure to a Class 2 laser is not known to be harmful This symbol indicates that this product affords electrical protection as Class II equipment as described in IEC 601 1 Part 1 D This Way Up Represents the limitations of temperature for storage This product must not be disposed of via municipal waste collection Separate collection for electrical and electronic equipment waste per Directive 2002 96 EC in the European Union is required Contact the manufacturer for details Lot Number Expiry Date Use by YYYY MM DD or YYYY MM IMPORTANT Indicates that inconvenience to the operator may result if the instruction is not followed Note Provides or refers the operator to additional or background information that may be helpful to them Do not reuse Re order Number Catalog Number AO D P wa 8 Bf Questions Refer to Page 10 10 for Technical Support Instructions Chapter 12 Specifications
14. Fraficiencu Data amp Linearitu Data 2 Press Scan to scan the Patient ID barcode If you enter the ID manually you may be Scan E or Enter or manually enter the Patient ID via the required enter it a second time to ensure it is Patient ID keypad if enabled correct While the Patient ID may be up to 30 digits not all digits will fit on the display The monitor may also be set to truncate ignore selected digits of the bar code 3 You can select one of the followin The number that appears to the right of p Smith John Ll options i 1 Previous and 2 Next on the P ed E Press 1 Previous indicates the number of tests available for sl mmol L Press 2 Next review The display also shows Glucose When finished reviewing the data Patient ID or Name p prompt E i ke E you can Comment Code Number in box l Preujauz a Press Clear to return to the Test Type Glucose or Ketone Apart E Patient ID entry screen Date and Time of test Press Menu to return to the Operator ID 0 prompt Menu Mode menu i 105 mg dL Press On Off to turn off the monitor Deere m Mx Questions Refer to Page 10 10 for Technical Support Instructions Chapter 5 Data Review O Data Review for All Patient Data Please refer to the beginning of this Data Review chapter for step by step instructions to access the Data Review menu Note The following section illustrates some common settings Depending on your institution s specifi
15. Precision Xceed Pro System For technical assistance please contact your local office or distributor listed below ASIA Australia and New Zealand Abbott Australasia Abbott Diabetes Care Victoria Australia Australia Tel 1 800 801 478 New Zealand Tel 0800 106 100 China Abbott Laboratories Ltd Shanghai China Tel 800 820 3959 Hong Kong Abbott Laboratories Ltd North Point Hong Kong Tel 852 2806 4488 Indonesia Abbott Indonesia Jakarta Selatan Indonesia Tel 62 21 52961529 Japan Abbott Japan Co Ltd Chiba ken Japan Tel 0120378 055 Korea Abbott Korea Ltd Seoul Korea Tel 080 014 5757 Malaysia Abbott Laboratories M Sdn Bhd Shah Alam Selangor Malaysia Tel 00 603 5569 1919 Pakistan Abbott Laboratories Pakistan Ltd Karachi Pakistan Tel 92 21 504 5680 Philippines Abbott Laboratories Metro Manila Philippines Tel 632 6890 495 Singapore Abbott Laboratories S Pte Ltd Singapore Tel 65 6272 2881 Taiwan Abbott Laboratories LTD Taipei Taiwan Tel 0800 521 125 Thailand Abbott Laboratories Ltd Bangkok Thailand Tel 66 2 252 2004 EUROPE Austria Abbott Ges m b H Abbott Diabetes Care Vienna Austria Tel 0800 930 093 Belgium and Luxembourg Abbott Diabetes Care Louvain la Neuve Belgium Belgium Tel 0800 167 72 Luxembourg Tel 8002 54 87 Czech Republic Abbott Laboratories s r o Abbott Diabetes Care Prague Czech Republic Tel
16. Press Menu to return to the Operator ID 0 prompt Menu Mode menu Note that test date and time alternates with 45 mg dL Press On Off to turn off the monitor Operator ID Questions Refer to Page 10 10 for Technical Support Instructions Chapter 5 Data Review eo 6 Proficiency Test Proficiency Test Glucose Proficiency Test B Ketone Proficiency Test Proficiency Test Glucose Please use the following procedures to perform a proficiency test The Proficiency Test menu enables you to perform unknown sample test challenges if required by facility policy This functionality may or may not be available depending on the configuration of the monitor through the data management system The Proficiency Test is based on the Patient Test comment code By Note The following section illustrates some common settings Depending on your institution s specific settings some screens will display differently or not at all Ifthe monitor does not display the screens shown please refer to Chapter 10 Troubleshooting A IMPORTANT Patient testing should be run in patient test mode only What You See on the Display What You Do Comments 1 Press the On Off button to turn on The Abbott logo screen will appear in black the monitor for a few seconds and then will appear in gray to ensure that the display is functioning properly Next the software version will briefly appear 2 Press the Menu button The monitor starts in T
17. Q LATIN AMERICA Argentina Abbott Laboratorios de Argentina SA Buenos Aires Argentina Tel 0800 800 6334 Brazil Abbott Laboratorios do Brasil Ltda S o Paulo Brasil Tel 0800 703 0128 Chile Abbott Laboratorios de Chile Ltda Santiago Chile Tel 800 80 2226 Colombia Abbott Laboratorios de Colombi SA Bogot Colombi Tel 01 8000 522268 Dominican Republic Abbott Laboratorios Republica Dominicana Santo Domingo Dominican Republic Tel 809 566 7181 ext 263 Guatemala Abbott Laboratorios Guatemala Cotio Guatemala Tel 597 4109 Mexico Abbott Laboratorios Mexico Cuidad de Mexico Mexico Tel 01 800 711 2208 Peru Abbott Laboratorios Peru Lima Peru Tel 0 800 1 1215 Uruguay Abbott Laboratorios Uruguay SA Montivideo Uruguay Tel 000 4054 342 Venezuela Abbott Laboratories C A Caracas Venezuela Tel 0 800 Glucosa MIDDLE EAST AND AFRICA Israel ILEX Medical Ltd Rosh Ha ayin Israel Tel 972 3 938 5501 Turkey Abbott Diabetes Care Goztepe Istanbul Turkey Tel 0500 467 466 Saudi Arabia Abbott Diabetes Care Mediserv Riyadh Saudi Arabia Tel 800 0124 1238 South Africa ADC South Africa Abbott Laboratories Gauteng South Africa Tel 27 11 858 2000 uestions Refer to Page 10 10 for Technical Support Instructions NORTH AMERICA Canada Abbott Diabetes Care Mississauga Ontario Canada Tel 1 800 387 8378 English Tel 1 800 465 2675 French
18. Support Instructions Chapter 7 Linearity Test Q What You See on the Display Apply Level 1 Sample Analyzing Sample 20 Level 1 Test 1 2 3 mmoal L Scan or Enter Comment Code 45 mg dL Level 1 Test 1 2 3 mmol L Glucose 6 06 07 10 33 AM 1 Mew Level Same Level 45 mg dL 12 13 14 15 What You Do Follow the instructions in the CVC kit package insert Then apply a drop of the sample to the target area Wait for the monitor to analyze the sample and display the test result Note the result If required scan or manually enter the comment code and press Enter If there is no prompt to enter a comment code skip down to step 15 You can select one of the following options Press 1 New Level Press 2 Same Level Press the Menu button to return to the Menu Mode Press On Off to turn off monitor Remove the test strip from the monitor and discard it when finished testing Follow your facilitys biohazard disposal policy uestions Refer to Page 10 10 for Technical Support Instructions Comments When sufficient sample has been applied the monitor beeps displays Sample Accepted and automatically starts the test For a detailed description of the test strip target area refer to the Test Strips section of Chapter 1 The monitor counts down then displays the test result Ifan error is detected during the assay the assay is terminated and no result
19. The strip was removed durin Repeat the test with a new test strip P 8 P p testing 4330 Blood glucose may be too high to Repeat the test with a new test strip If the be read by the system or there may be a error occurs again confirm the result by problem with the test strip performing a laboratory reference test Questions Refer to Page 10 10 for Technical Support Instructions Chapter 10 Troubleshooting eo Symptom Error Message Explanation When a Control Test is Selected Unexpected Level Low expected High entered 1 ReEnter Lot Continue When a Linearity Test is Selected Hew Panel 456109 will replace Panel 173456 1 FeEnter kit Lot z Replace Panel When Data Review is Selected Ha Stored Tests Eutt X X X 1 Previous amp Henst E A control solution lot number has been entered for a different level of control test from the one that the monitor expected to run in the usual low to high sequence The user may choose to enter a different lot number usually for the expected level or to run the level of test that matches the lot number entered A new linearity kit lot number has been entered different from the linearity panel currently stored in the monitor Only one panel of data is stored The kit lot number may have been entered incorrectly or the user may choose to replace the earlier data There are no stored test results for the type of data requested The monitor is
20. This will show test results performed for particular patient starting with the most recent test All Patient Data This will display the test results for all patients starting with the most recent test Control Data This will show control test results starting with the most recent test Proficiency Data This will show proficiency test results starting with the most recent test Linearity Data This will show linearity test results by level and order y Note The monitor may be configured to require a valid Operator ID to view results Follow these steps to access the Data Review menu Note The following section illustrates some common settings Depending on your institution s specific settings some screens will display differently or not at all IFthe monitor does not display the screens shown please refer to Chapter 10 Troubleshooting What You See on the Display What You Do Comments 1 Press the On Off button to turn the The Abbott logo screen will appear in black monitor on for a few seconds and then will appear in gray to ensure that the display is functioning properly Next the software version will briefly appear 2 Press the Menu button The monitor starts in Test Mode The M butt ill t le th itor t SS 7 02 AM Nu a oggle the monitor to 1 Patient Test 2 Control Test 3 Press 1 to select Data Review 26 06 Of 9 02 AM LE 1 Data Review 2 Revienw Setup Proficiency Test 4 Linearity Test u
21. automatically turn off with the message Upload Successful Turning Off Contact your system administrator if the message continues to display after docking the monitor y Note Check the Precision Xceed Pro display for proper performance before every test If at any time the display screen becomes difficultto read discontinue use of monitor and contact your local Abbott Diabetes Care office or distributor uestions Refer to Page 10 10 for Technical Support Instructions Chapter 10 Troubleshooting Q When a Test is Selected What You See on the Display Low High Control Test Required Glucose 1 Exit Continue Test Memory Upload Required 1 Enit 2 Continue Low High Control Test Kequir ed ketone 1 Exit Continue Patient ID O3091971 Patient Data Hot Found 1 ReEnter ID Continue scan or Enter Patient ID Invalid ID Strip Lot What You Do The Glucose QC Interval Controls Expired option is set to Warn or Lockout and one or more control tests is past due The menu item 2 Continue appears only if this option is set to Warn If the option is set to Lockout each control test shown on the screen must be performed before the patient tests start The Upload Interval option is set to Warn or Lockout and the specified interval has been exceeded The menu item 2 Continue appears only if this option is set to Warn If the option is set to Lockout data must be up
22. control solutions after the expiry date printed on the bottles and the box After the bottle has been opened do not use after the discard date written on the bottle Invert the control solution bottle several times to ensure thorough mixing before use e Invert and tap the capped control solution bottle to remove air bubbles from the tip of the bottle e Wipe the control solution nozzle with a clean gauze or tissue before and after each test e Do not scan one test strip foil packets bar code and use a test strip from another foil packet This may cause incorrect results to be generated e Replace the correct cap on the bottle and tighten the cap immediately after each use When To Test with Control Solutions e As required by your facilitys quality policy or local regulatory requirements e To verify the performance of the Precision Xceed Pro System Workflow The monitor expects to run control tests in the following order If a control level is disabled the monitor will expect to skip it If B ketone testing is disabled the operator will not receive a prompt to perform this test 1 Low Glucose 2 Mid Glucose 3 High Glucose 4 Low Ketone 5 Mid Ketone 6 High Ketone A IMPORTANT Do not allow control solution to drip down into monitor port uestions Refer to Page 10 10 for Technical Support Instructions Chapter 4 Control Test O Q Control Test Procedure Glucose Use the following procedure to perform glucose c
23. detected during the assay the assay is terminated and no result is displayed Once the assay begins all key presses are ignored until the assay is completed Control test results can appear as numeric or PASS FAIL depending on how the test is set up If numeric an X will appear in front of a test result that is out of range The monitor may be enabled to scan or enter a 1 to 2 digit comment code The display shows Level Low Mid High Comment Code Number in box Test Type Ketone Date and Time of test Operator ID 0 prompt Note that test date and time alternates with Operator ID If 1 is selected the Scan or Enter Control Lot screen will appear Return to step 1 to perform the Next Level of control test If 2 is selected the Scan or Enter Strip Lot screen will appear Repeat the test Chapter 4 Control Test 5 Data Review Data Review for Patient by Operator ID Data Review for Patient by Patient ID Data Review for All Patient Data Data Review for Control Data Data Review for Proficiency Data Data Review for Linearity Data The Precision Xceed Pro Monitor stores the results of up to 2 500 patient tests 1 000 control tests 20 proficiency tests and 2 linearity panels This data can be retrieved by the following categories Patient by Operator ID OperID This will show test results performed by a particular operator starting with the most recent test Patient by Patient ID PatID
24. e Decide the number of days before the Operator ID is set to expire that the operator will see a notification on the monitor Strip Lot e Decide whether an operator can continue to test allow test or warn or not lockout when a strip lot is scanned or entered to the monitor for a lot of strips that is not on the approved strip lot list The maximum number of strip lots that can be downloaded to the Precision Xceed Pro Monitor is 36 18 Glucose and 18 Ketone Other e Decide what additional information to download to a monitor through the data management system Lists of operators lists of strip lots or lists of patients e Determine whether the monitor displays results in mg dL or mmol L Glucose only e Decide whether any additional free text comments are stored with a test record These can be required optional or not used e Decide whether to configure the monitor for proficiency tests e Decide whether to configure the monitor for linearity tests Determine what language such as English displays on the monitor e Turn the audible indicator off on Configure the monitor to use alkaline or rechargeable batteries e Decide how soon the monitor automatically turns off between 4 10 minutes after a patient test e Decide whether to enable B ketone testing e Date display configuration on the monitor The date can be configured to the following formats e dd mm yy e dd mm yy e mm dd yy e Time display configuration on
25. following is recommended by UL for the Intended signal input and signal output connections complying with this requirement UL 60601 1 1st edition The use of ACCESSORY equipment not complying with the equivalent safety requirements of this equipment may lead to a reduced level of safety of the resulting system Consideration relating to the choice shall include e Use of the accessory in the PATIENT VICINITY e Evidence that the safety certification of the ACCESSORY has been performed in accordance to the appropriate IEC 601 1 and or IEC 601 1 1 harmonized national standard Patient Vicinity UL 60601 1 1st edition In areas in which patients are normally cared for the patient vicinity is the space with surfaces likely to be contacted by the patient or an attendant who can touch the patient This encloses a space within the room 1 83 m 6 feet beyond the perimonitor of the bed examination table dental chair treatment booth and the like in its intended location and extending vertically 2 29 m 7 1 2 feet above the floor Other Information The device is rated for use in oxygen rich environments The device is rated for continuous operation This device was evaluated against IEC 60601 1 2 Operation of this device may affect or be affected by other equipment in the vicinity of the device If an effect is observed increase the distance between devices uestions Refer to Page 10 10 for Technical Support Instructions Chapter 12 Specific
26. is displayed Once the assay begins all key presses are ignored until the assay is completed The monitor may be enabled to scan or enter a 1 to 2 digit comment code The display shows Level test level 1 through 5 Test replicate 1 through 4 for that level Comment Code Number in box Date and Time of test Operator ID o prompt Note that test date and time alternates with Operator ID If 2 is selected the Scan or Enter Strip Lot screen will appear Return to step 8 to continue linearity testing with the Same Level If 1 is selected the Select Level screen will appear Return to step 7 to perform linearity tests for a New Level Chapter 7 Linearity Test 8 Review Setup Monitor Configuration Review Setup Review Test Setup for All Tests Review Test Setup for Test Type Review Test Setup for Patient Test Review Test Setup for Control Test Review Test Setup for Security system Status Monitor Configuration The Precision Xceed Pro Monitor configuration settings are enabled via the data management system These settings can be viewed on the hand held device but cannot be changed on it Settings that are configured through the data management system are Upload interval Length of time between data uploads Whether you can continue to test allow test or warn or not lockout Operator ID Whether the Operator ID is required optional or not used for all tests Define the Opera
27. is due soon the message Glucose QC Due in xx min will display on the main screen The xx is the countdown to expiration If glucose QC is due now the message Glucose QC Due Now will display on the main screen If ketone QC is due soon the message Ketone QC Due in xx min will display on the main screen The xx is the countdown to expiration If ketone QC is due now the message Ketone QC Due Now will display on the main screen If the monitor requires an upload to the data management system Upload Due Now will display on the main screen How To Respond 1 Press 1 2 Remove test strip 3 Insert new test strip If Glucose QC Due in xx min is displayed no action is required Glucose testing can proceed If Glucose QC Due Now is displayed then Glucose QC testing per your facilitys procedures may be required before proceeding with a glucose test Contact your system administrator if the messages continue to display after running the required QC tests If Ketone QC Due in xx min is displayed no action is required Ketone testing can proceed If Ketone QC Due Now is displayed then Ketone QC testing per your facilitys procedures may be required before proceeding with a ketone test Contact your system administrator if the messages continue to display after running the required QC tests Place the monitor in the Abbott Docking Station and wait for the monitor to
28. of control solutions and or test strips If the results are still out of range contact your local Abbott Diabetes Care office or distributor uestions Refer to Page 10 10 for Technical Support Instructions Chapter 10 Troubleshooting O Troubleshooting Out of Range Linearity Test Results Repeat the test for that linearity level and make sure that the operator meets the conditions in this checklist e Use only the RNA Medical brand Glucose and pD Ketone Calibration Verification Control CVC kit that is compatible with the type of test strip being used Please refer to the package insert in the CVC kit for compatible test strip types and detailed instructions for use Eliminate any air bubbles in the CVC bottles tip Calibrate the monitor using the bar code for the test strip used Confirm that CVC solutions and test strips have been stored within the ranges specified on their respective cartons and package inserts Check that the temperature conditions in the room where the tests are being performed are within the acceptable operating ranges as specified in the respective Test Strip and CVC kit package inserts e Check CVC bottle for open bottle expiry date e Use a new test strip for each test e Use only Precision Xceed Pro Test Strips or Precision PCx Plus Test Strips e Confirm that the CVC solution tested level 1 5 matches the level requested on the display If test results are out of range despite meeting the above criteria ple
29. strip If the results still appear higher or lower than expected contact your local Abbott Diabetes Care office or distributor Troubleshooting Out of Range Control Test Results Repeat the test for that control solution and make sure that the operator meets the conditions in this checklist Eliminate any air bubbles in the control bottles tip Wipe the control solution nozzle with a clean gauze or tissue before and after each test Liquid left on the tip from previous tests may have a Glucose or D ketone concentration higher than expected Calibrate the monitor using the bar code for the test strip used Scan or enter the correct 5 digit lot number for the control solutions Confirm that control solutions and test strips have been stored within the ranges specified on their respective cartons and package inserts Check that the temperature conditions in the room where the tests are being performed are within the acceptable operating range as specified in the Test Strip package insert Check that the bottles of control solutions have not been open for more than 90 days Usea new test strip for each test Use only Precision Xceed Pro Test Strips or Precision PCx Plus Test Strips Use only MediSense Precision or Optium Control Solutions Confirm that the control solution tested low or high matches the level requested on the display If test results are out of range despite meeting the above criteria please repeat the test using a new box
30. the monitor The time can be configured to the following formats e hh nm AM PM h mm AM PM e AM PM h mm e hh mm 24 hour Action Range Critical Range e Decide whether to set an action range and what the range will be e Decide whether to set a critical ranges and what the range will be Questions Refer to Page 10 10 for Technical Support Instructions Chapter 8 Review Setup O Q Review Setup What You See on the Display Note This section illustrates some representative settings Ifthe monitor does not display these screens please refer to Chapter 10 Troubleshooting What You Do 1 Press On Off to turn on the monitor 26 06 07 2 Press the Menu button 2 02 AH iE 1 Patient Test 2 Control Test 26 06 07 3 Press 2 to select Review Setup 2 02 AH i 1 Data Review Z KEevieur Setup o Proficiency Test 4 Linearity Test uestions Refer to Page 10 10 for Technical Support Instructions Comments The Abbott logo screen will appear in black for a few seconds and then will appear in gray to ensure that the display is functioning properly Next the software version will briefly appear The monitor starts in Test Mode The Menu button will toggle the monitor to Menu Mode Chapter 8 Review Setup Review Test Setup for All Tests Ay Note This section illustrates some representative settings Ifthe monitor does not display these screens please refer to Chapter 10 Troubleshooti
31. to the Test Strips section of Chapter 1 The monitor counts down then displays the test result Ifan error is detected during the assay the assay is terminated and no result is displayed Once the assay begins all key presses are ignored until the assay is completed The monitor may be enabled to scan or enter a 1 to 2 digit comment code The monitor may be enabled to scan or enter the free text information Up to two free text fields may appear Chapter 3 Patient Test eo Q What You See on the Display p Smith John l 3 9 mmal L 76 06 07 1 Mext Patient z Patient History A What You Do For out of range results refer to your a Action Range institution s policy 11 9 Glucosa Scan or Enter Comment Code 207 mg dL Above Action Range For out of range results refer to your a Critical Range institution s policy 222 2 mmol L Glucose Scan or Enter Comment Cade gt 400 mg dL Above Critical Range 13 You can select one of the following options Press 1 Next Patient Press 2 Patient History Press Menu to return to the Menu Mode menu Press On Off to turn off the monitor Remove the test strip from the monitor and discard it when finished testing Follow your facilitys biohazard disposal policy Glucose a 3r Hh 105 mg dL Comments Your institution may establish an Action Range The monitor will display results outside of this range A comment code may be re
32. touch notch and tear down to remove the test the test strip anywhere when removing it strip from the foil to insert it into the monitor OA 8 With the contact bars facing up insert the Prior to inserting the test strip ensure that Insert test strip into the test strip port until it the port protector is installed and that it Strip stops and Strip Inserted is displayed is clean and dry Replace if necessary The display will alternate between Insert Strip and Glucose Questions Refer to Page 10 10 for Technical Support Instructions Chapter 6 Proficiency Test O Q What You See on the Display Apply Sample Analyzing Sample 20 5 5 mmol L Glucose Scan or Enter Comment Code 105 mg dL 1254756 3 9 mmoal L Glucose Z o6 D6 0r 3 51 AM 1 Hext Jest 105 mg dL 9 What You Do Bring proficiency survey specimens to room temperature Mix each specimen well according to instructions from the survey provider Wipe away any specimen on the tip of the vial before squeezing the vial and applying a drop to the test strip target area covering the entire area After applying the sample recap the vial tightly 10 Wait for the monitor to analyze the 11 12 sample and display the test result If required scan or manually enter the comment code and press Enter If there is no prompt to enter a comment code skip down to step 12 You can select one of the following option
33. Continue scan or Enter Strip Lot Enter Sample Type 1 Hrterial Capillaru ena What You Do Press 2 to Confirm Patient ID or 1 to ReEnter the ID Enter the year of birth e g enter 63 for 1963 enter 01 for 2001 then press the Enter button Press 2 to Continue testing or 1 to ReEnter the ID 6 Press Scan to scan the test strip bar code or manually enter the test strip lot number via the keypad then press Enter 7 Ifusing Precision PCx Plus Test Strips the Sample Type screen may appear You can select one of the following Press 1 Arterial Capillary or Press 2 Venous 8 Open the foil test strip packet at the notch and tear down to remove the test strip uestions Refer to Page 10 10 for Technical Support Instructions Comments Press Clear to re enter the ID If numbers have been entered the Clear key will erase those first Multiple presses ofthe Clear key may be required to return to the Patient ID entry screen in step 4 Scanning the bar code identifies the strip type calibrates the monitor ensures the expiry date has not passed records the strip lot used and checks that the lot has been approved for use by your institution Use Venous mode only for venous samples that have been in capped tubes and that have not been mixed with air Use Arterial Capillary mode for all other samples If the sample type screen is not seen continue with step 8 With clean dry hands you may
34. Control Test Ketone Result Fazz F ail 1 Hext 5 Press 1 Next to continue to the Control Test Ketone Result screen 6 Press 1 Next to continue to the Control Test Comment Code If In Range screen uestions Refer to Page 10 10 for Technical Support Instructions Chapter 8 Review Setup Review Test Setup for Control Test What You See on the Display What You Do Comments 7 Press 1 Next to continue to the Control Test Comment Code If Out of Range screen Control Test Comment Code If In Eanae Disabled 1 Mext 8 Press 1 Next to return to the Control Test Test Setup menu Comment Code If ut of Eanage Disabled 1 Mext 8 8 Questions Refer to Page 10 10 for Technical Support Instructions Chapter 8 Review Setup O Review Test Setup for Security Ay Note This section illustrates some representative settings Ifthe monitor does not display these screens please refer to Chapter 10 Troubleshooting What You Do Comments What You See on the Display 1 Press 1 for Test Setup Feujeu Setup 1 Jest Setup 2 System Status Test Set 2 Press 5 for Security to continue to the Sse Security Glucose QC Interval screen 1 All Tests 2 Test Type gt Patient Test 4 Controal Test D Securitu 3 If Ketone testing is enabled press 1 Next to continue to the Security Ketone QC Security Glucose Interval screen otherwise press 1 Next IJ Interval to skip down to step 5 Allow Test 24 hours
35. Glucose Test RD Blood B Ketone Test Strip 90090090 0900900 9090509090905 ORO SS SS SS eee e O OOOO OOOO 50525 X For in vitro vD IVD diagnostic use 30 C Store between 4C 4 30 C 39 86 F 525 M ade in UK ARTURO po B ws RODEO AS s DOCO OOOO SOOO Ino 34110 60606565362 For in vitro Abbott For in vitro Abbott diagnostic use diagnostic use lood B Ketone lood A Ketone 30 C fests trip 30 C fest trip o Store between En Di abetes Care Ltd Hf Store between pon Diabete s Care Lt PCE ao TC Range Road 30 C 39 86 Pow Winey Oron 0X29 OYL 4 30 C 39 86 Wits oun 0X29 OYL ARTO7249 Rev C 1 06 Made i ARTO7249 Rev C 1 06 Made in UK nge Ad Wy Bon OX29 OYL LAA 75 7 7 4 RRR ESI 0000001010 5090909090900 LoT 68yk2g 33 63 mg dl Py cision z UEXP 2007 09 21 66 120 mg dL POS Plus 68yk2g26e1nr94 219 369 mg dL Al Q a o J al x J A LoT 71C1K0 0610 mmo A AA U Exp 2007 09 21 18 28 mmol L E 33 53 mmol L E Ketone 71C1K01Ave7dk6 LOT 41C15H co 33 63 mg dL W Exp 2007 09 21 mip 66 120 mg dL 41C15H2zwnhp03 219 369 mg dl IMPORTANT The Precision Xceed Pro System will only work with Precision Xceed Pro or Precision PCx Plus brand test strips Use of any other test strip may cause erroneous results ART11960 Rev A ART11852 Rev ART12290 Rev A Control Solutions Control solutions are used to perform regular quality control checks on the monitor to ensure it is fu
36. Limitations eo REP Authorized Representative Do not drink sf CE CE is the mark that indicates that an item has been approved for distribution in the EU Legal Manufacturer under In Vitro Diagnostic Medical Devices Directive 98 79 EC Abbott Diabetes Care Consult instructions for use Recyclable For in vitro diagnostic use only STERILE R Method of sterility for Lancets only Sterilized using irradiation Lancets only controls etc that contain human blood or serum as potentially infectious PON WARNING Potential Biohazard Consider all clinical specimens reagents SK Always wear gloves and follow your facilitys biohazard safety policies and procedures Bar Code Types Codabar Codabar is a self checking numeric only bar code Codabar can encode the digits 0 through 9 six symbols and the start stop characters A B C D E N or T Codabar is used in libraries blood banks the overnight package delivery industry and a variety of other information processing applications Code 128 A bar code type that provides excellent density for all numeric data and good density for alphanumeric data The Code 128 standard is maintained by AIM Automatic Identification Manufacturers Code 39 A bar code type that is widely used in many industries and is the standard for many government bar code specifications including the U S Department of Defense Code 39 is defined in American National Standard
37. Mode 1 Patient Test 1 Data Review 2 Control Test 2 Patient by Pat ID 3 All Patient Data 4 Control Data 5 Proficiency Data 6 Linearity Data 2 Review Setup 1 Test Setup 2 System Status Battery Power 3 Proficiency Test Temperature 7 Time 4 Linearity Test Date 1 Patient by OperlD 1 All Tests 2 Test Type 3 Patient Test 4 Control Test 5 Security Software Version Upload Interval Operator ID Operator ID Truncation Operator ID Prompt Glucose Units Glucose Action Range Glucose Critical Range Ketone Action Range Ketone Critical Range Patient ID Patient ID Truncation Comment Code If In Range Comment Code If Out of Range Patient ID Prompt Repeat Manual ID Entry Levels Result Comment Code If In Range Comment Code If Out of Range QC Interval Operator ID Not Certified Strip Lot Not on List Patient Data Not Confirmed Confirm Patient Data Q uestions Refer to Page 10 10 for Technical Support Instructions Chapter 2 Using the Monitor 3 Patient Test Operating Guidelines for All Samples Collecting Blood Samples How to Obtain a Capillary Blood Sample How to Obtain a Venous Blood Sample How to Obtain an Arterial Blood Sample How to Obtain a Neonatal Capillary Blood Sample Disposing of Waste Patient Test Procedure Glucose Patient Test Procedure B Ketone Patient Test This chapter describes the steps to be taken to test patient blood
38. ORTANT Do not apply blood to the test strip when the test strip is out of the monitor Do not use wet bent scratched or damaged test strips Each test strip is protected by a foil packet bearing an individual bar code label The foil packet maintains the integrity of each test strip by protecting it from exposure to air and moisture and accidental contamination The bar code label holds information about the test strip including the lot number calibration expiry date and expected control solution ranges One quick scan provides the monitor with all this information at the time of the test IMPORTANT Do not scan a packet s bar code and usea test strip from another packet This may cause A incorrect results to be generated Use the test strip immediately after opening its foil packet Do not use the test strip if the foil packet has a puncture or tear in it There are three types of test strips that may be used for testing with the Precision Xceed Pro system the light blue Precision Xceed Pro Blood Glucose Test Strip in blue foil the green Precision PCx Plus Blood Glucose Test Strip in gold foil for testing glucose levels in fresh whole blood and the purple Precision Xceed Pro Blood Ketone Test Strip in purple foil for testing D ketone levels in fresh whole blood Inside each box of test strips is a package insert with detailed instructions for use Precision Xceed Pro Precision PCx Plus Precision Xceed Pro Blood Glucose Test Strip Blood
39. Reinosa ob Peu sU dinis is 10 2 bags dcc I E 10 2 Technical Support TRIS CHC COS pecs cscs ieee NEE EAEE E 10 10 POTO ia UaUUporcio RR NN NN o E A EO 10 10 Contacte ADDON TOR aci 10 11 Ti Maintenance T Mm 11 CVE AI the Eno Uco 11 1 Replacing the Port Proein cita 11 2 eE A o E E AAE A eer 11 2 Replacing the Date tia 11 2 12 Spe aO aa E da 12 Precision Xceed Pro Monastir IPIE NM aE aR MEUS 12 1 vro eT E E E N EE E oo 12 2 Bar ode ion 12 3 loiportane ate SACOS sinaia EE E expec EEE ce 12 4 Questions Refer to Page 10 10 for Technical Support Instructions 1 Overview Intended Use TruelD TrueMeasure and TrueAccess Icons and Warnings Conventions System Components Overview Q Intended Use The Precision Xceed Pro Point of Care System for Blood Glucose and B Ketone Monitoring is intended for in vitro diagnostic use for the quantitative measurement of glucose D glucose in fresh capillary venous arterial and neonatal whole blood samples and of p Ketone beta hydroxybutyrate in fresh capillary and venous whole blood samples The system is not for use in diagnosing diabetes mellitus but is to be used as an aid in monitoring the effectiveness of diabetes control programs The Precision Xceed Pro System simplifies point of care testing for healthcare professionals providing features that enhance th
40. Strip Lot Number o Control Solution Lot Number Jo c 3 Obtain the most recent linearity results and record them below papa po Dus A LL A ExpetedRange o Test Strip Lot Number _Linearity Solution LotNumber J me o 4 Enter the date the problem occurred 5 Describe the problem and the conditions when it occurred 6 Have the Precision Xceed Pro Monitor and testing materials available when calling Returning an Instrument Regulations in various jurisdictions require that medical instruments be decontaminated prior to shipping to minimize the risk of exposing those persons involved in handling or transporting the instrument Prior to returning an instrument to Abbott please perform the following steps 1 Remove all potentially contaminated accessories such as lancets unused test strips or control solution bottles 2 Wipe the surface of the instrument with a detergent solution to remove any soiling 3 Wipe the unit with a tuberculocidal disinfectant or isopropyl alcohol 4 Package and label the instrument s as required by local regulations To dispose of a monitor please contact your local Abbott Diabetes Care office or distributor Questions Refer to Page 10 10 for Technical Support Instructions Chapter 10 Troubleshooting D Contacting Abbott for Service Abbott is committed to helping you resolve any problems with the
41. Up to 2 195 meters 7 200 feet Humidity From 10 to 90 noncondensing Mains Supply Voltage Fluctuations 10 Transient Over Voltages 1 5KV Rated Rated Pollution Degree 2 uestions Refer to Page 10 10 for Technical Support Instructions Chapter 12 Specifications Limitations O Q Symbols There are special symbols that appear on the Precision Xceed Pro Monitor Test Strips and Docking Station The complete list of symbols and explanations are listed below Please note Some ofthe symbols listed below will not appear on your Precision Xceed Pro System due to differences in local regulatory requirements Indicates a Glucose assay black text on white Indicates a p Ketone B hydroxybutyrate assay white text on purple Refers to Type BF Equipment Per EN60601 1 Refers to Type B Equipment Per EN60601 1 The double arrow symbol indicates the connector to be used for data transfer The double arrow symbol may appear on the front panel of the docking station beneath the LED display refer to Data Upload Chapter 9 f gt gt e 2 d Medical Equipment with respect to electric shock fire and mechanical hazards only in accordance with UL 60601 1 and CAN CSA 22 2 NO 601 1 c SS C p co c Ww gt Z AVOID EXPOSURE Laser light is emitted from this aperture CAUTION Output 1 0 mW Wavelength 650 nm Complies with 21 CFR 1040 10 and IEC 60825 1 2001 CDRH Class IT IEC Class 2 Laser product
42. ase repeat the test using a new CVC kit and or test strips If the results are still out of range contact your local Abbott Diabetes Care office or distributor Error Messages In this section you will find information relating to error messages that appear on the display when the Precision Xceed Pro Monitor detects errors For each corresponding message an explanation is given and appropriate responses are described In many situations it may be possible to proceed with some of the functions at least temporarily before attending to the problem For example when the batteries are too low to permit testing it may be possible to review data for a short time If any problem persists record the error message displayed which may include a 4 digit error code and contact your local Abbott Diabetes Care office or distributor When You Turn on the Monitor or During Use Symptom Error Message Explanation How To Respond The monitor has little or no power Verify proper battery installation If the problem persists install new batteries See Chapter 11 Maintenance for more information The display is blank Battery power is getting low Testing willbe Install new batteries available for a limited time See Chapter 11 Maintenance for more information Low Battery Press 1 to turn monitor off 1 Turnina ff Occurs when any test is selected and Press 1 to Exit Turn monitor off Allow the t mius the temperature is o
43. ata amp Linearitu Data 2 You can select one of the following The number that appears to the right of p Smith Jahn El options 1 Previous and 2 Next on the monitor Press 1 Previous indicates the number of tests available for 5 8 mmol L Press 2 Next review The display also shows Glucose When finished reviewing the data Patient ID or Name p prompt 003931937 you can Comment Code Number in box 1 Frevious J Press Clear to return to the Test Type Glucose or Ketone 2 NMaut 2 Data Review menu Date and Time of test Press Menu to return to the Operator ID 0 prompt Menu Mode menu Note that test date and time alternates with 105 mg dL Press On Off to turn off the monitor Operator ID Questions Refer to Page 10 10 for Technical Support Instructions Chapter 5 Data Review Data Review for Patient by Patient ID Please refer to the beginning of this Data Review chapter for step by step instructions to access the Data Review menu Note The following section illustrates some common settings Depending on your institution s specific settings some screens will display differently or not at all If the monitor does not display the screens shown please refer to Chapter 10 Troubleshooting What You See on the Display What You Do Comments 1 Press 2 to select Patient by PatID The monitor will show test results for a lata Review specific patient Patient bu perID Patient bu PatlO 5 RHII Patient Data 4 Control Data a
44. ations Limitations o Q Standards Compliance The Precision Xceed Pro System has been evaluated against the following standards UL 60601 1 1st ed Medical Electrical Equipment Part 1 General Requirements for Safety CSA C22 2 No 601 1 M90 Medical Electrical Equipment Part 1 General Requirements for Safety EN 60601 1 2nd ed Medical Electrical Equipment Part 1 General Requirements for Safety CSA 22 2 No 61010 1 4 EN 60601 1 Medical Electrical Equipment Part 1 General Requirements for Safety Incorporates Corrigendum July 1994 Includes Amendments Al 1993 A11 1993 A12 1993 A2 1995 and A13 1996 IEC 601 1 1988 Al 1991 A2 1995 Corrigendum 1995 Modified IEC 61010 2 101 2002 01 Safety Requirements for Electrical Equipment for Measurement Control and Laboratory Use Part 2 101 Particular Requirements for in Vitro Diagnostic IVD Medical Equipment First Edition EN 60601 1 2 2001 Class A Medical Electrical Equipment Part 1 2 General Requirements for Safety Collateral Standard Electromagnetic Compatibility Requirements and Tests IEC 60601 1 2 2001 IEC 60601 1 Medical Electrical Equipment Part 1 General Requirements for Safety Second Edition IEC 60601 1 1 2nd ed Medical Electrical Equipment Part 1 1 General requirements for safety Collateral standard Safety requirements for medical electrical systems IEC 60601 1 2 1993 04 Medical Electrical Equipment Part 1 General Requirement
45. c settings some screens will display differently or not at all If the monitor does not display the screens shown please refer to Chapter 10 Troubleshooting What You See on the Display What You Do Comments 1 Press 3 to select All Patient Data The monitor will show all patient test results lata Fevjeu starting with the most recent result 1 Patient bu perID z Patient bu PatIl 5 HII Patient Data 4 Control Data a Praficieneu ata amp Linearitu Data 2 You can select one of the following The number that appears to the right of p Smith John ll options 1 Previous and 2 Next on the monitor E e Press 1 Previous indicates the number of tests available for a Kil mmol L Press 2 Next review The display also shows Glucosa When finished reviewing the data Patient ID or Name p prompt 0 521 9 37 you can Comment Code Number in box l Preupausz a Press Clear to return to the Test Type Glucose or Ketone 7 Haut T Data Review screen Date and Time of test Press Menu to return to the Operator ID o prompt Menu Mode menu Note that test date and time alternates with 105 mg dL Press On Off to turn off the monitor Operator ID Questions Refer to Page 10 10 for Technical Support Instructions Chapter 5 Data Review e Data Review for Control Data The monitor stores the last 1 000 control test results Please refer to the beginning of this Data Review chapter for step by step instructions to access the Data Review menu
46. creen allows you to set all bar code data entry options for the Operator ID and Patient ID The types of bar codes selected determine what codes can be scanned into the Monitor Refer to the Meter Component Manual for detailed information Important Safety Instructions DANGER e Misuse of electrical equipment can cause electrocution burns fire and other HAZARDS e Basic safety precautions should always be taken including all those listed below e Close supervision is necessary when equipment is used by on or near children handicapped persons or invalids READ THIS BEFORE USING THE EQUIPMENT Do not place the equipment in liquid nor put it where it could fall into liquid Use the equipment only for the purpose described in the instructions for use Do not use accessories which are not supplied or recommended by the manufacturer Do not use the equipment if itis not working properly or if it has suffered any damage o NOTE Examples of typical defects include damage caused by dropping the equipment damage caused by dropping the equipment into water or splashing water onto it Do notlet the equipment come into contact with surfaces which are too hot to touch Do not place anything on top of the equipment Unless specifically instructed to do so by the instructions for use do not drop or put anything into any opening in the equipment Do not use the equipment out of doors KEEP THESE INSTRUCTIONS Signal Output and Signal Input Parts The
47. detected during Sample the assay the assay is terminated and no result is displayed Once the assay begins all key presses are ignored until the assay is 1 0 completed 4 If prompted scan or manually enter the The monitor may be enabled to scan or comment code and press Enter enter a 1 to 2 digit comment code O Gamat If there is no prompt to enter a comment The monitor may display out of range Ketone code skip down to step 5 results similar to those for Glucose if Scan or Enter enabled for Q ketone testing The monitor may be also be enabled amment Lade y to scan or enter up to two free text information fields 5 You can select one of the followin The display shows p Smith John Ll Sons p Patient ID or Name p prompt 0 Bu al L Press 1 Next Patient Comment Code Number in box m E Press 2 Patient History Date and Time of test ETONE Test Type Ketone 65 06 10 r 23 51 AM Press Menu to return to Menu Mode If 1 is selected the Scan Patient ID screen 1 Hent Patient Ies will appear Return to Step 1 to continue Patient History Press On Off to turn off the monitor with testing on the next patient Remove the test strip from the monitor If 2 is selected the monitor will display the and discard it when finished testing last test result for this patient as well as allow Follow your facilitys biohazard disposal you to view previous results policy Questions Refer to Page 10 10 for Technical Su
48. e reliability of the testing process and that support compliance with point of care policies TruelD Easy Data Entry Patient ID Confirmation Data Integrity TrueMeasure Fast Simple Testing Simple Calibration QC Lock out TrueAccess Operator Management Results Storage Network Connectivity uestions Refer to Page 10 10 for Technical Support Instructions Choose between the built in bar code scanner and the alphanumeric keypad for entering data as required by point of care testing policy The monitor can be configured to accept patient identification operator identification test strip lot number comment code and up to two free text fields for other data such as physician name The monitor can display the patient name date of birth and gender for confirmation supporting positive patient identification procedures Entry of the year of birth also can be required for confirmation Many options are available to help ensure that correct data is collected with each test including specifying the minimum and maximum length of an ID restricting the types of bar codes to be accepted using a check digit to verify the bar code or requiring repeated entry of data on the keypad if the bar code scanner is not used The monitor also records the method of patient and operator identification data entry scanned versus manually entered on the keypad to help Point of Care Coordinators identify and correct errors To perform a test sim
49. e that the display is functioning properly Next the software version will briefly appear 2 Press the Menu button The monitor starts in Test Mode The Menu button will toggle the monitor to 6 06 07 az AM Menu Mode L1 1 Patient Test 2 Control Test 3 Press 2 select Review Setup 66 01 202 AH I 1 Data Review 2 Keview Setup A Froficiencey Test 4 Linearity Test 4 Press 2 to continue to the System Status Review Setup Battery Power screen 1 Test Setup 2 Sustem Status 5 Press 1 Next to continue to the System System Status Status Temperature screen Battery Power 2 32 1 Mext Questions Refer to Page 10 10 for Technical Support Instructions Chapter 8 Review Setup e What You See on the Display What You Do Comments System Status 6 Press 1 Next to continue to the System Status Time screen Temperature 25 9 C 1 Hext 7 Press 1 Next to continue to the System System Status Status Date screen Time 9 39AH 17 Hour h mm ANFPA 1 Hext 8 Press 1 Next to continue to the System Status Software Version and System Status Serial Number screen late 26 06 07 dd mm uy 1 Hext 9 Press 1 Next to continue to the Review The number that appears on your monitor Setup menu may be different from the number that uer 10 appears here APOTZ9ADD02001 34d 1 Hext Questions Refer to Page 10 10 for Technical Support Instructions Chapter 8 Review Setup e 9 Data Upload Docking Station Mountin
50. eact in the presence of glucose to make a small electric current This current is passed through the strip to the contact bars and the monitor which calculates a glucose result Target Area Contact Bars Precision Xceed Pro Blood Glucose Test Strips use proprietary glucose specific chemistry that includes the glucose dehydrogenase enzyme NAD cofactor and PQ mediator GDH NAD This chemistry is used for testing glucose because it is not affected by maltose icodextrin and other common substances at normal therapeutic levels It also ensures minimal measurement bias from oxygen haematocrit and other physiological variables Precision Xceed Pro Blood p Ketone Test Strips are also available for use with the Precision Xceed Pro System These test strips have chemistry to specifically measure D hydroxybutyrate the primary ketone body produced when a patient is developing ketoacidosis Both glucose and p ketone test strips also have exclusive blood application features to ensure reliable sampling First the target area may be filled by applying a drop of sample to the top of the test strip or by dipping the end of the test strip in the sample Second the fill trigger electrode ensures that the test will only start once sufficient blood has been applied Together these features minimize the possibility of errant results due to sample application technique Fill Trigger Electrode Working Electrode Reference Electrode A IMP
51. ed in a capillary tube coated with heparin or EDTA and then applied to the test strip e Alternately you can use the heel to strip method Allow a hanging drop of blood to form from the heel and apply to the target area of the test strip Results will not be impacted by gently touching the heel to the test strip A Disposing of Waste EX Observe the following guidelines when disposing of biohazardous waste e Dispose of used lancets in an approved sharps container e Discard used capillary tubes disposable transfer pipettes or tips and test strips in an approved biohazard container e Follow your facility s biohazard disposal policy Questions Refer to Page 10 10 for Technical Support Instructions Chapter 3 Patient Test eo Patient Test Procedure Glucose Use the following procedure to perform a patient test using the Precision Xceed Pro or Precision PCx Plus Blood Glucose Test Strip By Note The following section illustrates some common settings Depending on your institution s specific settings some screens will display differently or not at all If the monitor does not display the screens shown please refer to Chapter 10 Troubleshooting What You See on the Display What You Do Comments 1 Press On Off to turn on the monitor The Abbott logo screen will appear in black for a few seconds and then will appear in gray to ensure that the display is functioning properly Next the software version will briefly appear
52. ent Test Comment Code If Out of Range Comment Code screen If In Eanae Disabled 1 Heut Patient Test 6 Press 1 Next to continue to the Patient Test Patient ID Prompt screen Comment Cade If ut af Eanae Disabled 1 Hent Patient Test 7 Press 1 Next to continue to the Patient Test Repeat Manual ID Entry screen Patient 10 Prompt Patient ID 1 Heart Patient Test 8 Press 1 Next to return to the Test Setup menu Repeat Manual ID Entry Disabled 1 Heart Questions Refer to Page 10 10 for Technical Support Instructions Chapter 8 Review Setup O Review Test Setup for Control Test Ay Note This section illustrates some representative settings Ifthe monitor does not display these screens please refer to Chapter 10 Troubleshooting What You Do Comments What You See on the Display Q Rele Setup 1 Tezt Setup 2 System Status Test Setup 1 All Tests d Test Type A Patient Test 4 Control Test D Security Control Test Glucose Levels Low High 1 Heart Control Test 1 Press 1 for Test Setup 2 Press 4 for Control Test to continue to the Control Test Glucose Levels screen 3 Press 1 Next to continue to the Control Test Glucose Result screen 4 If Ketone testing is enabled press 1 Next to continue to the Control Test Ketone Glucose Faezult Levels screen otherwise press 1 Next Fazz F ail to skip down to step 7 1 Heut Control Test Ketone Levels Low High 1 Hext
53. ent cover allows you to check supply status without opening the case L7 EY Docking Station optional The docking station provides a convenient way to upload the data from the monitor to the data management system When the monitor is placed in the docking station it will automatically upload data to the data management system and then shut down Data upload is further described in Chapter 9 Data Upload Cable optional Alternatively a data upload cable is available to connect the monitor to the computer running the data management system C Any Data Management System A computer running a data management system is necessary to configure and upload results from the Precision Xceed Pro Monitor Abbott s PrecisionWeb Point of Care Data Management System and software from other vendors are available Data upload from remote locations requires either Terminal Servers or networked PCs running Abbott s Data Repeater software Questions Refer to Page 10 10 for Technical Support Instructions Chapter 1 Overview o 2 Using the Monitor Bar Code Scanner Data Entry Keypad Audible Indicator Data Port Battery Compartment Port Protector Monitor Identification Menu Tree Using the Monitor Bar Code Scanner The bar code scanner enables you to scan the information into the monitor instead of manually entering the data using the keypad Scanning the bar code on the test strip foil packet aut
54. est Mode The 6 06 O7 az AR Menu button will toggle the monitor to Menu Mode 1 Fatient Test 2 Control Test 3 Press 3 to select Proficiency Test 26 U6 Of 3 02 AM I 1 Data Review 2Z Eevieur Setup o Proficiency Test 4 Linearity Test Scan ar Enter 4 Press Scan to scan the Operator ID bar While the Operator ID may be up to 30 ID code or manually enter the Operator ID digits not all digits will fit on the display perator via the keypad then press Enter The monitor may also be set to truncate ignore leading trailing and or selected 22 22222 digits of the bar code OPERATOR Scan or Enter Sample ID 5 Scan or manually enter the Sample ID via The monitor will prompt for the Sample ID the keypad then press Enter to be scanned or entered PROF indicates proficiency test uestions Refer to Page 10 10 for Technical Support Instructions Chapter 6 Proficiency Test Q Q What You See on the Display What You Do Comments 6 Press Scan to scan the test strip bar Scanning the bar code identifies the strip Scan or Enter code or manually enter the test strip lot type calibrates the monitor ensures the Strip Lot number via the keypad then press Enter expiry date has not passed records the strip lot used and checks that the lot has been Esa um nam uum Gm Gam nas nus DER NN Gu GER GN GEM approved for use by your institution 7 Open the foil test strip packet at the With clean dry hands you may gently
55. estions Refer to Page 10 10 for Technical Support Instructions Chapter 5 Data Review O Q What You See on the Display What You Do Comments 4 Press Scan to scan the Operator ID While the Operator ID may be up to 30 Scan or Enter bar code or manually enter the digits not all digits will fit on the display Operator ID Operator ID via the keypad then press The monitor may also be set to truncate Enter ignore leading trailing and or selected digits of the bar code OPERATOR 5 Choose the category of data to review lata RFeuiem 1 Patient bu perID z Patient bu PatILl S All Patient Data d Control Data a Fraficieneu Data amp Linearitu Data Questions Refer to Page 10 10 for Technical Support Instructions Chapter 5 Data Review e Data Review for Patient by Operator ID Please refer to the beginning of this Data Review chapter for step by step instructions to access the Data Review menu Note The following section illustrates some common settings Depending on your institution s specific settings some screens will display differently or not at all If the monitor does not display the screens shown please refer to Chapter 10 Troubleshooting What You See on the Display What You Do Comments 1 Press 1 to select Patient by OperID The monitor shows the result of the lata Review most recent patient test you performed 1 Patient bu perIl Patient bu Patll All Patient Data 4 Contral Data a Pratficiencu D
56. for Technical Support Instructions Chapter 11 Maintenance of the Precision Xceed Pro Monitor eo 12 Specifications Precision Xceed Pro Monitor Symbols Bar Code Types Important Safety Instructions Specifications Precision Xceed Pro Monitor Dimensions Length 19 7 cm 7 7 in Width 7 5 cm 2 96 in Thickness 5 33 cm 2 1 in Weight 256 grams 9 ounces Power Source Two standard alkaline AA batteries or nickel metal hydride NiMH rechargeable batteries not supplied by Abbott Diabetes Care Battery performance is a function of how often the monitor is used and the duration time that testing is conducted Alkaline Battery 2 cells 1 5 Volts 2 8 Amp Hours typical capacity Rechargeable NiMH batteries 2 cells 1 2 Volts 1 1 Amp Hours minimum capacity not supplied by Abbott Diabetes Care Memory Patient Test Results 2 500 Control Test Results 1 000 Operator IDs 6 000 Test Strip Lots 36 18 Glucose 18 Ketone Proficiency Test Results 20 Glucose Linearity Test Results 20 Results 1 panel 5 levels 4 replicates per level Ketone Linearity Test Results 20 Results 1 panel 5 levels 4 replicates per level Patient IDs 6 000 patient records name gender date of birth Environmental Specifications Product is intended for indoor use only Monitor Operating Temperature 15 C to 40 C 59 F to 104 F Monitor Storage Temperature 20 C to 50 C 4 F to 122 F Altitude
57. g Instructions Enabling Data Upload Data Upload Once the test results have been collected during a prescribed period of time they can be uploaded into the data management system The data management system provides a simple and automated way to collect report and transfer data To start the upload of data simply place the Precision Xceed Pro Monitor into the docking station The monitor will first turn on if it isn t already and then automatically upload data to the data management system Please Wait Data Uploading During communications the Data Uploading screen appears and the arrows rotate to indicate that the system is working The arrows may occasionally pause During data upload the monitor cannot be used for testing After upload is complete the monitor will display Upload Successful Turning Off and then shut down By Note fthe monitor is removed before data transmission is complete some data may not be uploaded The data will be uploaded as part of the next data transmission If a problem occurs with the data upload an error message may appear on the monitor If the monitor is removed from the docking station while an upload is in process the monitor will display Last upload incomplete Redock meter Turning Off The monitor will then shut down Error messages are shown in Chapter 10 Troubleshooting Further troubleshooting information for any data upload question is provided in the data management user manual
58. gently touch the test strip anywhere when removing it from the foil to insert it into the monitor Chapter 3 Patient Test What You See on the Display Inzert Strip A Apply Sample Analyzing Sample 20 5 5 mmal L Glucose Scan or Enter Comment Code 105 mg dL 5 6 mmol L Glucose Scan ar Enter Patient ID 2 105 mg dL What You Do 9 With the contact bars facing up insert the test strip into the test strip port until it stops and Strip Inserted is displayed 10 Apply a drop of blood from the patients finger transfer pipette or syringe to the target area of the test strip 11 Wait for the monitor to analyze the sample and display the test result 12 If required scan or manually enter the comment code and press Enter If there is no prompt to enter a comment code skip down to step 13 If prompted scan or manually enter the free text information and press Enter If there is no prompt to enter free text skip down to step 13 uestions Refer to Page 10 10 for Technical Support Instructions Comments Prior to inserting the test strip ensure that the port protector is installed and that it is clean and dry Replace if necessary The display will alternate between Insert Strip and Glucose When sufficient sample has been applied the monitor beeps displays Sample Accepted and automatically starts the test For a detailed description of the test strip target area refer
59. glucose or D ketone levels in fresh whole blood using the Precision Xceed Pro System Inside each box of test strips is a package insert with detailed instructions for use Operating Guidelines for All Samples Please follow the recommended guidelines for the most accurate results A Always wear gloves and follow your facility s biohazard safety policies and procedures when performing tests involving patient blood samples Make sure that the monitor and test strips are at room temperature If the monitor is moved to an area that is warmer or cooler than where it was before allow the monitor to reach the new room temperature before testing Use only control solutions specified in the test strip package insert to verify the performance of the Precision Xceed Pro Monitor Use only Precision Xceed Pro Blood Glucose or Blood Ketone Test Strips Precision PCx Plus Blood Glucose Test Strips may also be used with the Precision Xceed Pro Monitor Refer to the package insert for specific directions on storage and use of the test strips Do not use the test strips beyond the expiry date printed on the foil packet and outer box Do not use the test strip if the foil packet has a puncture or tear Do not use test strips that are wet bent scratched or damaged Use the test strip immediately after opening its foil packet Use each test strip only once Do not scan a test strip packet s bar code and then use a test strip from a different packet Th
60. he ID will be confirmed Decide whether comment code is required optional or not used for patient tests that are in the acceptable range for the facility and the test strip Decide whether comment code is required optional or not used for patient tests that are outside of the acceptable range for the facility and the test strip Control Tests Set which levels of control solution are required optional or not used by your facility The monitor can be configured to run any combination of low mid and high control solution tests Set whether control solution test results display as numeric or as Pass Fail Determine whether a comment code is required optional or not used for control tests that are within the acceptable range for the facility and the test strip Decide whether a comment code required optional or not used for control tests that are outside of the acceptable range for the facility and the test strip QC Interval Determine how frequently QC tests need to be run This can be set to a number of hours or up to three specified times during the day Decide whether the operator can continue to test allow test or warn or not lockout when the QC interval is expired Questions Refer to Page 10 10 for Technical Support Instructions Chapter 8 Review Setup O Operator ID e Decide whether an operator can continue to test allow test or warn or not lockout when the Operator ID has expired
61. il it the port protector is installed and that it stops and Strip Inserted is displayed is clean and dry Replace if necessary The display will alternate between Insert Strip and Glucose 8 Gently invert the required control When sufficient sample has been applied Apply Low solution bottle 3 4 times Remove the cap the monitor beeps displays Sample Solution of the control solution bottle and wipe the Accepted and automatically starts the test For a detailed description of the test strip target area refer to the Test Strips section of Chapter 1 nozzle with a clean gauze or tissue Apply a small drop of solution to the test strip target area allowing the target area to fill completely Wipe the nozzle of the control solution bottle before replacing the cap y Note Do not lift the monitor to view the display until after the test strip has been removed Doing so may cause control solution to drip onto the port protector or into the strip port damaging the monitor Ifthe port protector becomes wet replace it with a new one Questions Refer to Page 10 10 for Technical Support Instructions Chapter 4 Control Test eo What You See on the Display What You Do Comments Analyzing Sample 20 Low 1 3 3 6 X 5 5 mmole Glucose Scan or Enter Comment Code 99 mg dL Low PHSS Glucose 6 06 0 10 06 HM 1 Hest Level z Repeat Test 9 Wait for the monitor to analyze the sample and display the test resu
62. is may cause inaccurate results Apply a drop of blood to the target area at the end of the test strip Allow the entire target area to fill with blood The test results will not be affected if the target area has been briefly touched with the patient s finger a capillary tube syringe or pipette After the blood is applied to the test strip and the test countdown begins do not remove or disturb the test strip IMPORTANT Do not allow blood or other solution to run down the test strip into the monitor s test strip port as it may cause irreparable damage to the monitor Questions Refer to Page 10 10 for Technical Support Instructions Chapter 3 Patient Test ED Collecting Blood Samples How to Obtain a Capillary Blood Sample Use only fresh whole blood samples Make sure that the sampling site is clean and dry before lancing Collect the capillary blood using a lancing device and an appropriate technique Apply a drop of blood to the target area at the end of the test strip Allow the entire target area to fill with blood If necessary blood can be collected in a capillary tube coated with heparin or EDTA and then be applied to the test strip within 30 minutes of collection How to Obtain a Venous Blood Sample e Use only fresh whole blood samples e Collect the venous blood sample in a collection tube containing heparin or EDTA Make sure that the tube is filled to the stated volume Do not under fill e Do not use col
63. ketane Scan or Comment Enter Code 123475 1 2 ono 26 06 SH 1 Henst Test 9 55 AM What You Do 1 Follow steps 1 through 8 in the last section on the Glucose Proficiency Test Make sure you use the purple Blood D Ketone test strip for the blood D Ketone Proficiency Test The monitor will recognize the strip based on the bar code 2 Bring proficiency survey specimens to room temperature Mix each specimen well according to instructions from the survey provider Wipe away any specimen on the tip of the vial before squeezing the vial and applying a drop to the test strip target area covering the entire area After applying the sample recap the vial tightly 3 Wait for the monitor to analyze the sample and display the test result 4 If required scan or manually enter the comment code and press Enter If there is no prompt to enter a comment code skip down to step 5 5 You can select one of the following options Press 1 Next Test Press Menu to return to Menu Mode menu Press On Off to turn off the monitor Remove the test strip from the monitor and discard it when finished testing Follow your facilitys biohazard disposal policy uestions Refer to Page 10 10 for Technical Support Instructions Comments Prior to inserting the test strip ensure that the port protector is installed and that it is clean and dry Replace if necessary The display will alternate between Inser
64. l automatically proceed to the next screen The scanning beam shuts off in three seconds if nothing is detected The beam could cause permanent damage to the eye CDRH Class II IEC IMPORTANT Never look into the bar code scanner beam or point it toward anyone s eyes Class 2 Laser Product Avoid Long Term Viewing of Direct Laser Light Data Entry Keypad VOO TIS OCO OOO Scan NI Press this button to operate the bar code scanner If the audible indicator is enabled the monitor will E beep once a bar code has been successfully scanned Continuing to hold the scan button will display the scanned bar code on the display until the button is released If no information is scanned after 3 seconds the scanner will turn off The data entry keypad allows you to enter identification numbers and letters only the 26 letter English alphabet or to select an option that appears on the display The keypad contains a 10 digit telephone style keypad with the keys for the numbers 0 9 The 2 9 keys also have letters printed below the number The keypad also has six special keys including a scan button on off button backlight alphanumeric clear menu and enter key uestions Refer to Page 10 10 for Technical Support Instructions Chapter 2 Using the Monitor O Q On Off Press this button to turn the monitor on Each time the monitor is turned on the Abbott logo screen will appear in black for a few seconds and then will appear in gra
65. le instruments monitor point of care and report test data to the Laboratory Information System LIS or Hospital Information System HIS for inclusion in the patient s Electronic Medical Record EMR Chapter 1 Overview Icons and Warnings Information that is of particular relevance to the reader is called out in gray boxes throughout the manual with an appropriate icon and warning level A IMPORTANT Indicates that inconvenience to the operator or danger to the patient may result if the instruction is notfollowed y Note Provides or refers the operator to additional or background information that may be helpful to them Conventions The glucose unit of measure is set using the data management system It is not changed via the monitor keypad In this manual when a monitor screen shot shows a glucose test result in one unit of measure e g mmol L the equivalent value in the other unit of measure e g mg dL appears below the image D ketone test results always appear in the mmol L unit of measure p Smith John E p Smith John E 5 5 mmol tL OBa Glucose 6 06 07 3 31 AM 26 06 07 3 51 AM 1 Mext Patient 1 Mext Patient Patient History Patient History 105 mg dL A IMPORTANT Please confirm that the correct unit of measure shows on your monitor with every glucose result Questions Refer to Page 10 10 for Technical Support Instructions Chapter 1 Overview eo System Components The Precision Xceed Pro Monit
66. lection tubes that contain fluoride or oxalate e Ifthe blood is collected from an intravenous line clear the line before drawing the sample into a heparinized syringe Use the sample within 30 minutes of collection Invert the tube with the sample several times immediately before removing the sample Use a disposable transfer pipette to obtain a sample from the center ofthe collection tube Apply a drop of blood to the target area at the end of the test strip Allow the entire target area to fill with blood How to Obtain an Arterial Blood Sample e Use only fresh whole blood samples e Clear the arterial line before drawing a blood sample into a heparinized syringe e Use the sample within 30 minutes of collection e Mix the blood specimen well immediately before applying the sample to the target area of the test strip e Allow a drop of blood to form at the tip of the syringe e Apply a drop of blood to the target area at the end of the test strip Allow the entire target area to fill with blood How to Obtain a Neonatal Capillary Blood Sample heel stick e The following procedures should only be performed by a trained professional y e Use only fresh whole blood samples eni e Collect the capillary blood using a lancing device and an appropriate technique 2 e Apply a drop of blood to the target area at the end of the test strip Allow the entire target I De l area to fill with blood e The blood can be collect
67. loaded before testing starts The Ketone QC Interval Controls Expired option is set to Warn or Lockout and one or more control tests is past due The menu item 2 Continue appears only if this option is set to Warn If the option is set to Lockout each control test shown on the screen must be performed before the patient tests start The system cannot confirm the Patient ID The scanned Patient ID is similar in format to the test strip bar code uestions Refer to Page 10 10 for Technical Support Instructions Comments Perform the remaining glucose control tests indicated in the message 1 Place the monitor in the docking station to upload the data Or Press 2 to Continue testing 2 If the problem persists contact the system administrator Perform the remaining ketone control tests indicated in the message Press 1 to ReEnter Patient ID Or Press 2 to Continue testing 1 Re enter the Patient ID using the bar code scanner or keypad 2 If the problem persists contact the system administrator Chapter 10 Troubleshooting During Any Test Symptom Error Message Scan or Enter Strip Lot Invalid Lot Barcode Scan or Enter Strip Lot Invalid Lot late Expired Scan or Enter Linearity Kit Lot Invalid ID Too Long Strip Lot 0350136401 T0502 Is Hot on the Strip Lot List 1 ReEnter Lot Continue Strip Error Glucose expected Ketone entered 1 Hew Strip Z2 Enit
68. lt 10 Note the test result and whether it 11 falls within the acceptable range If required scan or manually enter the comment code and press Enter If there is no prompt to enter a comment code skip down to step 11 You can select one of the following Press 1 Next Level Press 2 Repeat Test Press Menu to return to the Menu Mode menu Press On Off to turn off the monitor Remove the test strip from the monitor and discard it when finished testing Follow your facilitys biohazard disposal policy The monitor counts down then displays the test result If an error is detected during the assay the assay is terminated and no result is displayed Once the assay begins all key presses are ignored until the assay is completed Control test results can appear as numeric or PASS FAIL depending on how the test is set up If numeric an X will appear in front of a test result that is out of range The monitor may be enabled to scan or enter a 1 to 2 digit comment code The display shows Level Low Mid High Comment Code Number in box Test Type Glucose Date and Time of test Operator ID o prompt Note that test date and time alternates with Operator ID If 1 is selected the Scan or Enter Control Lot screen will appear Return to step 4 to perform the Next Level control test If 2 is selected the Scan or Enter Strip Lot screen will appear Return to step 5 to Repeat Test at the sa
69. me level Note f 8 ketone testing is disabled then following a complete set of Glucose controls Next Level becomes 1 Exit If B ketone testing is enabled and Glucose QC is run first then following a complete set of Glucose controls 1 Next Level becomes 1 QC Ketone If B ketone testing is enabled and B ketone QC is run first then following a complete set of f ketone controls 1 Next Level becomes 1 QC Glucose Questions Refer to Page 10 10 for Technical Support Instructions Chapter 4 Control Test Q Control Test Procedure B Ketone Use the following procedure to perform Q ketone control tests If B ketone testing is enabled the monitor will prompt for the Blood p Ketone Test Strip By Note The following section illustrates some representative settings Ifthe monitor does not display these screens please refer to Chapter 10 Troubleshooting What You See on the Display Insert Strip um Apply Low Solution Analyzing Sample 10 Low 0 6 1 0 D e noi ketane Scan or Enter Comment Code Low 2 PASS 10 13 AM 6 UE 1 Mest Level z Repeat Test What You Do 1 Repeat steps 1 through 6 from the previous Glucose Control Test Procedure Insert the purple Blood f Ketone Test Strip into the test strip port until it stops and Strip Inserted is displayed The monitor will recognize the strip based on the bar code 2 Gently invert the required control solution bottle 3
70. nctioning correctly Control testing is further described in Chapter 4 Use Precision Optium or MediSense Blood Glucose and p Ketone Control Solutions with the Precision Xceed Pro System These control solutions are available in one two or three level configurations Q uestions Refer to Page 10 10 for Technical Support Instructions Chapter 1 Overview o Calibration Verification Controls Use RNA Medical brand Glucose and p Ketone Calibration Verification Controls to confirm the calibration and analytical measurement range of the monitor for Precision Xceed Pro Blood Glucose or Blood D Ketone Test Strips Use RNA Medical brand Glucose Calibration Verification Controls with Precision PCx Plus Blood Glucose Test Strips This is called linearity testing and requires a kit with 5 levels of control solution Linearity testing is further described in Chapter 7 Isolation Bag optional Abbott Isolation Bags are disposable plastic bags for use with the Precision Xceed Pro System The Isolation Bag provides a partial barrier between the point of care monitoring device and the patients in isolation for infection control There is no need to prep the monitor prior to using the bag and the bag does not affect any monitor functions Note that Abbott Isolation Bags are not sterilized Carry Case optional The carry case holds the monitor test strips control solutions the quick reference guide and other accessories needed for testing A transpar
71. ng What You See on the Display What You Do Comments 1 Press 1 for Test Setup Rebel Setup 1 Tezt Setup 2 System Status 2 Press 1 for All Tests to continue to the Test Setup All Tests Upload Interval screen 1 All Tests 2 Test Type A Fatient Test 4 Control Test SI Security 3 Press 1 Next to continue to the All Tests All Tests Operator ID screen Upload Interval Allow Test 74 hours 1 Hext 4 Press 1 Next to continue to the All Tests All Tests Operator ID Truncation screen Operator ID Optional 1 30 digits 1 Hext 5 Press 1 Next to continue to the HII Tests All Tests Operator ID Prompt screen perator ID Truncation Firzt Last 1 Hext 6 Press 1 Next to return to the HII Tests Test Setup menu Operator ID Frompt Operator ID 1 Hext Questions Refer to Page 10 10 for Technical Support Instructions Chapter 8 Review Setup O Review Test Setup for Test Type Ay Note This section illustrates some representative settings Ifthe monitor does not display these screens please refer to Chapter 10 Troubleshooting What You See on the Display What You Do Comments 1 Press 1 for Test Setup Review Setup Tezt Setup System Status 2 Press 2 for Test Type to continue to the Test Setup Test Type Glucose Units screen 1 Hll Tests 2 Test Type A Patient Test d Control Test O Securitu 3 Press 1 Next to continue to the au Test Type Glucose Action Range screen Units mmol L Heut 4 Press 1 Nex
72. ning of this Data Review chapter for step by step instructions to access the Data Review menu Note The following section illustrates some common settings Depending on your institution s specific settings some screens will display differently or not at all If the monitor does not display the screens shown please referto Chapter 10 Troubleshooting What You See on the Display What You Do Comments 1 Press 5 to select Proficiency Data The monitor shows the most recent Data Review proficiency test result 1 Patient bu Operll Patient bu Patll All Patient Data 4 Contral Data a Fratficiencu Data e Linearitu Data 2 You can select one of the following The number that appears to the right of options 1 Previous and 2 Next on the monitor S123456 Press 1 Previous indicates the number of tests available for e E Press 2 Next review The display shows the following Al mmol L When finished reviewing the data Sample ID s prompt Glucose you can Comment Code Number in box Z6 06 0r 4 51 Ah Press Clear to return to the Test Type Glucose or Ketone 1l FPreuinu sz 4 Data Review screen Date and Time of test z Maut 2 Press Menu to return to the Operator ID 0 prompt Menu Mode menu l Note that test date and time alternates with 105 mg dL Press On Off to turn off the monitor Operator ID Questions Refer to Page 10 10 for Technical Support Instructions Chapter 5 Data Review Data Review for Linearity Data The monitor st
73. not able to recall a previous test result This test result may not have been uploaded from the monitor Questions Refer to Page 10 10 for Technical Support Instructions How To Respond Press 1 to ReEnter the lot Or Press 2 to run the level of test that matches the lot number already entered Press 1 to ReEnter a different linearity kit lot number typically the number of the previous kit Or Press 2 to proceed and Replace Panel using the new kit lot number The existing linearity data will be replaced by data from the new lot Press 1 to Exit and return to the Data Review Menu Press 1 to view the Previous result Or Press 2 to view the Next result Chapter 10 Troubleshooting Technical Support Instructions Abbott Technical Support contact information is listed on the following two pages When you call an Abbott representative will address the problem and or instruct you to return the monitor test strips control solution and or linearity kit Do not return the Precision Xceed Pro Monitor or any part of the system for repair until you receive authorization from an Abbott representative To help ensure efficient resolution of the problem complete the following steps before calling Abbott 1 Review the troubleshooting information in this section 2 Obtain the most recent control results and record them below Control Solution Low Mid High If used If used If used Expected Range C LL Test
74. omatically enters the test strip information calibration control range lot number and expiry date The scanner may also be used to enter Operator ID Patient ID control lot number comment code and free text e E fields To operate the monitor EE LES Step 1 Place the bar code on a Esa flat surface Step 2 Hold the bar code scanner 6 24 cm 3 12 inches from the bar code to be scanned and ata 30 to 135 degree angle to the bar code Step 3 Press and hold down the Scan button until a visible red beam is emitted by the monitor Step 4 Slowly move the monitor if needed so that the red beam is directly over the bar code Step 5 The monitor will beep in acknowledgement when it accepts the bar code ijl YE SA AS ES PUIG LEA PLDP IILI EAW AZ MAT By Note fyou hold the Scan button for three seconds the scanner stops Reposition scanner and try again Optimal distance depends on bar code type When first learning to use the bar code scanner some precautions should be taken It is important that you place the object to be scanned on a flat surface or hold it by itself This will prevent other items from being accidentally scanned If data has been manually entered scanning data will erase the manually entered data unless the Enter key has been selected to confirm manual entry and replace it with the scanned data This entry will be considered scanned Upon a successful bar code scan this system wil
75. ontrol tests Note The following section illustrates some common settings Depending on your institution s specific settings some screens will display differently or not at all If the monitor does not display the screens shown please refer to Chapter 10 Troubleshooting What You See on the Display What You Do Comments 1 Press On Off to turn on the monitor The Abbott logo screen will appear in black for a few seconds and then will appear in gray to ensure that the display is functioning properly Next the software version will briefly appear 2 Press 2 to select Control Test The monitor starts in Test Mode The z amp Le L r 2 02 AR Menu button will toggle the monitor to cama Menu Mode 1 Patient Test 2 Control Test crean or Enter 3 Press Scan to scan the Operator ID bar While the Operator ID may be up to 30 Operator ID code or manually enter the Operator ID digits not all digits will fit on the display via the keypad then press Enter The monitor may also be set to truncate ignore leading trailing and or selected E digits ofthe bar code 4 Scan or manually enter the low control You can scan or manually enter the Scan ar Enter solution lot number via the keypad information from the control solutions Low Level then press Enter bar code For manual entry key in the five numeric digits of the lot number printed on solution Lot the control solution bottle You do not need um um um um mm to enter the alpha character tha
76. or is part of an overall system designed to simplify point of care testing These components are purchased separately and some are optional Precision Xceed Pro System Components The Precision Xceed Pro System includes the following items Monitor Blood Glucose Test Strips Blood B Ketone Test Strips optional Control Solutions Calibration Verification Controls optional Isolation Bags optional Carry Case optional Docking Station optional Data Upload Cable optional Data Management System IMPORTANT Use product and accessories only as directed Failure to operate the product s in accordance with the manufacturer s documentation may impair product safety Monitor The Precision Xceed Pro Monitor has many features Port designed to help simplify testing It can be used with one Protector ege hand either the left or the right The display has large text Test Strip Port and is backlit to make reading easy The keypad is similar to a telephone and each button clicks when pressed Use ofthe monitor is described in Chapters 2 through 8 of this Operators Manual and in the Quick Reference Guide available separately Bar Code Scanner Displa Atthetop ofthe monitor is the test strip port covered by the port protector The port protector is designed to minimize Monitor liquid entering the monitor through the strip port Chapter dentification Space 11 provides instructions for changing the protector
77. ores the last linearity panel that includes a maximum of 4 replicates for 5 levels 20 tests Please refer to the beginning of this Data Review chapter for step by step instructions to access the Data Review menu Note The following section illustrates some common settings Depending on your institution s specific settings some screens will display differently or not at all If the monitor does not display the screens shown please refer to Chapter 10 Troubleshooting What You See on the Display What You Do Comments 1 Press 6 to select Linearity Data The monitor shows linearity tests first by Data Fenjer level 1 2 3 4 5 then by order within 1 Patient bu OperTO each level If no tests are stored for a level 2 Patient bu FatIL then that level is skipped At the top of the All Patient Data display the level 1 through 5 and test d Control Data replicate 1 through 4 is displayed Proficiency Data e Linearitu Data 2 You can select one of the following The number that appears to the right of Level 1 Test 1 options 1 Previous and 2 Next on the monitor Press 1 Previous indicates the number of tests available for ian mmal L Press 2 Next review The display shows the following Glucose When finished reviewing the data Level 1 to 5 Test replicate 1 to 4 76 06 07 10 33 Ah you can Comment Code Number in box 1 Preuiauz Press Clear to return to the Test Type Glucose or Ketone oN aut m Data Review screen Date and Time of test
78. patient tests with the Precision Xceed Pro Blood p Ketone Test Strip The Precision Xceed Pro Monitor recognizes the type of test strip based on the scan of the strip bar code y Note The following section illustrates some common settings Depending on your institution s specific settings some screens will display differently or not at all Ifthe monitor does not display the screens shown please refer to Chapter 10 Troubleshooting What You See on the Display What You Do Comments 1 Follow steps 1 through 8 in the last Prior to inserting the test strip ensure that Inzert section on the Glucose Patient Test Insert the port protector is installed and that it Strip the purple Blood B Ketone Test Strip into 5 clean and dry Replace if necessary The the test strip port until it stops and Strip display will alternate between Insert Strip ia Inserted is displayed The monitor will and Ketone Ey recognize the strip based on the bar code 2 Apply a drop of blood from the patients When sufficient sample has been applied Apply finger transfer pipette or syringe to the the monitor beeps displays Sample Sample target area of the test strip Accepted and automatically starts the test For a detailed description of the test strip target area refer to the Test Strips section of Chapter 1 3 Wait for the monitor to analyze the The monitor counts down then displays Analyzing sample and display the test result the test result If an error is
79. pes are not recommended as they may fade the monitor keypad Cleaning solutions not listed have not been tested and may damage the monitor Contact your local Abbott Diabetes Care office or distributor for the most up to date information on cleaning solutions Turn off the monitor prior to cleaning Do not apply cleaning solution directly to the monitor If using a pre packaged wipe squeeze out excess fluid prior to use Do not immerse or autoclave the monitor or flood it with any liquid These steps will help keep liquid from entering the monitor and causing damage A IMPORTANT Do not allow liquid to enter the monitor Permanent damage could occur uestions Refer to Page 10 10 for Technical Support Instructions Chapter 11 Maintenance of the Precision Xceed Pro Monitor O Replacing the Port Protector The port protector is designed to minimize the possibility of liquid entering the monitor through the strip port Should blood or control solution come in contact with the port protector the monitor should be cleaned and dried and the port protector replaced Make sure to dry the area around the test strip port prior to installing the new port protector 2 1 Lift the port protector from its left or right edge 2 Pull gently away until the protector separates from the monitor 3 Rest the flat bottom of the new port protector on i Q Ay the ledge of the test strip port 4 Gently push both sides of the port protector until
80. ply insert a strip into the monitors port apply a small drop of blood and wait for the countdown to complete For convenience the sample may be applied to either the top or end of the test strip The test will not start until adequate sample has been applied Scanning the bar code label on each test strip foil packet prior to use automatically calibrates the monitor and checks the expiry date helping ensure reliable and accurate test results Testing can also be restricted to approved strip lots The monitor can be configured to require periodic testing using control solutions and to lock out access to the system if these tests are not completed QC results can be displayed as pass fail only preventing patient testing while in control test mode Access to the monitor can be restricted to certified operators locking out untrained users A warning can also be displayed to an operator whose ID is set to expire in the near future The Precision Xceed Pro Monitor can store up to 2 500 patient test results and 1 000 control test results in addition to 20 proficiency test results and 2 linearity panels All stored data can be automatically uploaded to the data management system using the docking station optional or a data upload cable optional Precision Xceed Pro Monitors can upload data and be configured via a central data management system across the organizations computer network This provides a simple and automated way to manage multip
81. pport Instructions Chapter 3 Patient Test 4 Control Test Operating Guidelines for Control Solution Testing Control Test Procedure Glucose Control Test Procedure B Ketone This chapter describes the steps for running a control test with control solutions Control tests verify the performance of the Precision Xceed Pro Monitor and Test Strips The quality control features of the monitor can be customized to fit the requirements of each facility The monitor can be set to require e Tests of low normal and high control solutions or a variation depending on the facility s policy e Tests of control solutions at relative times e g every 24 hours or fixed times e g at 6 00 a m 2 00 p m and 10 00 p m e Control test results to appear as numeric value or Pass Fail These quality control features can be set through the data management system Operating Guidelines for Control Solution Testing Observe the following guidelines to obtain optimal quality control results using the Precision Xceed Pro System e Use only control solutions approved for use with Precision Xceed Pro and Precision PCx Plus Test Strips to verify the performance of the Precision Xceed Pro Monitor and Test Strips e When opening a new bottle write the discard date on the bottle label Each bottle of control solution is stable for 90 days after opening or until the expiry date printed on the label whichever comes first e Do not use
82. quired for results outside the action range Your institution may establish a Critical Range The monitor will not display results outside of this range A comment code may be required for results outside the critical range The display shows Patient ID or Name p prompt Comment Code Number in box Date and Time of test Test Type Glucose If 1 is selected the Scan Patient ID screen will appear Return to step 4 to continue with testing on the next patient If 2 is selected the monitor will display the last test result for this patient as well as allow you to view previous results Refer to the section entitled Data Review for Patient by Patient ID in Chapter 5 for further information IMPORTANT If the blood glucose result appears to be inconsistent lower or higher than expected there may bea problem with the test strip Repeat the test using a new test strip Results that are incorrect may have serious medical consequences Consult the prescribing physician before making any changes to diabetes medication plans if e The blood glucose results are not consistent with the physical symptoms AND you have ruled out common errors in technique e The blood glucose result is less than 2 8 mmol L 50 mg dL or greater than 16 7 mmol L 300 mg dL uestions Refer to Page 10 10 for Technical Support Instructions Chapter 3 Patient Test Patient Test Procedure B Ketone Use the following procedure to perform
83. r digit error code and contact Abbott Technical Support The monitor has detected a problem with 1 Turn off the monitor Wait at least 5 Meter Error the barcode scanner that would prevent the seconds for the system to reset Turn 20172 scanner from operating This isatemporary on the monitor Turn Off error and can be corrected by re bootingthe 2 Ifthe problem persists repeat step dala scone monitor 1 confirming that the monitor has vee remained off for at least 5 seconds 1 Turn Uff 3 If the problem still persists record the 4 digit error code and contact Abbott Technical Support The test strip was inserted at the wrong Remove the test strip from the test strip port Remove time The monitor will beep if functions are Strip attempted before the strip is removed or if the test strip is left in when the test calls for the test strip to be removed Questions Refer to Page 10 10 for Technical Support Instructions Chapter 10 Troubleshooting eo Q When You Turn on the Monitor or During Use Symptom Error Message Strip Error ketone expected Glucose entered 1 Hew Strip z Euit 6 06 0f 10 14 AM A 1 Patient Test 2 Control Test Glucose GC One in 23 min Z 6 06 0f 10 14 AM 1 Patient Test 2 Control Test ketone GE Due How Z 6 06 0f 10 14 AM I 1 Patient Test 2 Control Test Upload Due Mow Explanation The strip type inserted does not match the type scanned If glucose QC
84. r the system nn Days administrator for further information about operator certification Continue Questions Refer to Page 10 10 for Technical Support Instructions Chapter 10 Troubleshooting O During Any Test Symptom Error Message Explanation How To Respond The test result is below the measuring 1 Repeat the test with a new test strip p Smith John E limit of the system 2 If the result persists follow your facility s 12 iz l 1 TES procedure 76 06 af T aT Al 1 Hext Patient Patient History 20 mg dL The test result is above the measuring 1 Repeat the test with a new test strip Emi limit of the system 2 If the result persists follow your facility s p Smith Jahn E p y y 28 procedure 26 6 UT TST AM 1 Hext Patient Patient History l The test strip or the test strip port is wet 1 Remove the old test strip trip defective contaminated or the 2 Press 1 to continue testing with a Error wrong test strip was inserted New Strip Wet or Damaged T Press 2 to Exit to the Test Menu 1 Hew Strip 2 Enit There may be a problem with the test strip 1 Press 1 to repeat the test with a New siae One of several 4 digit error codes may Strip or 2 to Exit n E be displayed These codes provide Abbott 5 If the error occurs again record the personnel additional information about the 4 digit error code and contact Abbott problem Errors include Technical Support 1 Hew Strip 2 Enit 4327
85. s Press 1 Next Test Press Menu to return to the Menu Mode Press On Off to turn off the monitor Remove the test strip from the monitor and discard it when finished testing Follow your facilitys biohazard disposal policy uestions Refer to Page 10 10 for Technical Support Instructions Comments When sufficient sample has been applied the monitor beeps displays Sample Accepted and automatically starts the test For a detailed description of the test strip target area refer to the Test Strips section of Chapter 1 The monitor counts down then displays the test result If an error is detected during the assay the assay is terminated and no result is displayed Once the assay begins all key presses are ignored until the assay is completed The monitor may be enabled to scan or enter a 1 to 2 digit comment code The display shows Sample ID s prompt Comment Code Number in box Test Type Glucose Date and Time of test Operator ID o prompt Note that test date and time alternates with Operator ID If 1 is selected the Scan or Enter Sample ID screen will appear Return to step 5 to perform the Next Test with another proficiency sample Chapter 6 Proficiency Test Q Proficiency Test B Ketone Please use the following procedures to perform a D ketone proficiency test What You See on the Display Insert Strip um Apply Sample Analyzing Sample 10 2 doni
86. s Institute ANSI standard MH10 8M 1983 Code 93 A bar code type that encodes exactly the same characters as Code 39 but uses nine bar code elements per character instead of 15 I2 of 5 Interleaved 2 of 5 I2 of 5 isa numeric only bar code widely used in warehouse and industrial applications The data must consist of an even number of digits EAN EAN is an abbreviation for European Article Numbering EAN 13 is used worldwide for marking retail goods It encodes 13 characters the first two are a country code followed by 10 data digits and a checksum Two digit and five digit supplemental bar codes may be added for a total of 14 or 17 data digits EAN 8 code is a shortened version of the EAN 13 code It includes a two digit country code five data digits and a checksum digit Two digit and five digit extension bar codes may be added Questions Refer to Page 10 10 for Technical Support Instructions Chapter 12 Specifications Limitations o RSS RSS is an abbreviation for Reduced Symbology Set which produces very small bar codes suitable for labeling electronic components and healthcare devices There are seven different types of RSS bar codes RSS can encode at maximum 74 characters n Note Control characters and non alphanumeric characters e g are displayed as spaces in the Precision Xceed Pro Monitor Some bar codes may contain control characters and non alphanumeric characters The Bar code Type section of the MeterCom s
87. s and detailed instructions for use Please use the following procedure to perform a Linearity Test This functionality may or may not be available depending on the configuration of the monitor through the data management system y Note This section is only for Point of Care Coordinators not operators It illustrates some common settings Depending on your institution s specific settings some screens will display differently or not at all Ifthe monitor does not display the screens shown please refer to Chapter 10 Troubleshooting A IMPORTANT Patient testing should be run in patient test mode only Results obtained in Linearity test mode should only be used to assess system linearity performance What You See on the Display What You Do Comments 1 Press On Off to turn on monitor 2 Press the Menu button 6 06 0r 24 02 AM fmm 1 Patient Test 2 Control Test 3 Press 4 to select Linearity Test 2 6 O6 Of 02 AM u 1 Data Review 2 Review Setup o Proficiency Test 4 Linearity Test 4 Press Scan or manually enter the Scan or Enter Operator ID via the keypad Operator ID then press Enter OPERATOR The Abbott logo screen will appear in black for a few seconds and then will appear in gray to ensure that the display is functioning properly Next the software version will briefly appear The monitor starts in Test Mode The Menu button will toggle the monitor to Menu Mode While the Operator ID may be up
88. s for Safety 2 Collateral Standard Electromagnetic Compatibility Requirements and Tests First Edition CENELEC EN 60601 1 2 1993 Precision Xceed Pro Monitor Class II EQUIPMENT energized from an internal electrical power source Docking Station Class II EQUIPMENT energized from an internal electrical power source Questions Refer to Page 10 10 for Technical Support Instructions Chapter 12 Specifications Limitations o
89. s power and if desired a working network connection 3 Ensure that the local data management system or Abbott Data Repeater for a networked connection is operational and correctly configured This software and its installation instructions are available separately 4 AC Adapter E A a it rd A iut iki li Wesce df i i RA amp Data Upload Cable Figure 2 Data Upload via Terminal Server 1 Connect the terminal server AC adapter to a power source 2 Connect the serial cable to the terminal server and to the docking station data transfer port Alternatively connect the Data Upload Cable to the terminal server and to the Data Port of the Precision Xceed Pro Monitor 3 Connect the data networking cable to the terminal server and the network jack By Note For plug connected equipment where protecting grounding is required plug the equipment into a supply outlet that has aground connection Chapter 9 Data Upload Questions Refer to Page 10 10 for Technical Support Instructions 10 Troubleshooting Troubleshooting Patient Test Results Troubleshooting Out of Range Control Test Results Troubleshooting Out of Range Linearity Test Results Error Messages Technical Support Instructions Returning an Instrument Contacting Abbott for Service Troubleshooting Troubleshooting Patient Test Results This section describes conditions that can cause erroneous patient test results Refer to the
90. st strip Or Press 2 to Exit Chapter 10 Troubleshooting eo Q uestions Refer to Page 10 10 for Technical Support Instructions During Any Test Symptom Error Message Explanation How To Respond The Operator ID just entered is not on the 1 Press 1 to ReEnter the ID using the bar Operator ID list of acceptable Operator ID s defined code scanner or keypad 23458 7S9 for this monitor Or Is Mot on the The menu item 2 Continue appear onl y Press 2 to Continue testing perator List if this option is set to Warn i 2 If the problem persists notify the system 1 PeEnter ID administrator 2 Continue The Operator ID entered is not on the list of 1 Press 1 to Re Enter the Operator ID Operator ID acceptable Operator IDS defined for 2 If the problem persists contact the system 1235458678 this monitor administrator for further information on Is Hot on the operator certification Operator List 1 ReEnter 10 perator ID The Operator ID entered has expired 1 Press 1 to re enter the ID using the bar O 75 The menu items 1 ReEnter ID and code scanner or keypad Date Expired 2 Continue appear only if this option Or is set to Warn Press 2 to Continue testing 1 FeEnter ID 2 If the problem persists notify the Continue system administrator 0 tor ID The Operator ID is due to expire At this 1 Press 1 to Continue testing erator TS ja e Iri time testing is still allowed 2 Contact your manager o
91. t Strip and Ketone When sufficient sample has been applied the monitor beeps displays Sample Accepted and automatically starts the test For a detailed description of the test strip target area refer to the Test Strips section of Chapter 1 The monitor counts down then displays the test result If an error is detected during the assay the assay is terminated and no result is displayed Once the assay begins all key presses are ignored until the assay is completed The monitor may be enabled to scan or enter a 1 to 2 digit comment code The display shows Sample ID s prompt Comment Code Number in box Test Type Ketone Date and Time of test Operator ID 0 prompt Note that test date and time alternates with Operator ID If 1 is selected the Scan or Enter Sample ID screen will appear Return to step 1 to perform the Next Test with another proficiency sample Chapter 6 Proficiency Test 7 Linearity Test Linearity Test The Linearity Test menu enables you to verify method linearity using a RNA Medical brand Glucose and p Ketone Calibration Verification Control CVC kit These kits contain assayed materials for use in confirming the calibration and linearity of glucose and ketone at the upper and lower limits of the reportable range and at three 3 points within the range CVC kits are designed for specific test strip types Please refer to the CVC package insert for compatible test strip type
92. t appears at MDE the end of the five digit number The Strip Lot screen will appear next If the Unexpected Level screen appears The monitor is programmed to expect Low Unexpected Level you may either Mid and High Glucose then Low Mid and 1 Press 1 to ReEnter the expected level High Ketone control tests in this order A Low expected 5 rece Si A warning message will appear if the controls Hia h entered i are used in a different order however you may still proceed with the test 1 ReEnter Lot Continue Questions Refer to Page 10 10 for Technical Support Instructions Chapter 4 Control Test O What You See on the Display What You Do Comments 5 Press Scan to scan the test strip bar Scanning the bar code identifies the strip Scan or Enter code or manually enter the test strip lot type calibrates the monitor ensures the Strip Lot number via the keypad then press Enter expiry date has not passed records the strip lot used and checks that the lot has been approved for use by your institution By Note Place monitor on a flat surface while running control tests 6 Open the foil test strip packet at the With clean dry hands you may gently touch notch and tear down to remove the test the test strip anywhere when removing it strip from the foil to insert it into the monitor 7 With the contact bars facing up insert the Prior to inserting the test strip ensure that test strip into the test strip port unt
93. t number or replace the existing lot number with the new lot number There can be up to 4 replicates per level The number in the parentheses indicates the number of replicates already run for that level When a level is full the number 4 will appear in parentheses indicating that all four replicates have been completed for this level For example 1 Level 1 4 Chapter 7 Linearity Test What You See on the Display What You Do Comments 9 Press Scan to scan the test strip bar Scanning the bar code identifies the strip Scan or Enter code or manually enter the test strip type calibrates the monitor ensures the Strip Lot lot number via the keypad then press expiry date has not passed records the strip Enter lot used and checks that the lot has been A approved for use by your institution 10 Open the foil test strip packet at the With clean dry hands you may gently touch notch and tear down to remove the test the test strip anywhere when removing it strip from the foil to insert it into the monitor oye Xo Do D D D A rr 11 With the contact bars facing up insert Prior to inserting the test strip ensure that Insert the test strip into the test strip port until the port protector is installed and that it Strip it stops and Strip Inserted is displayed is clean and dry Replace if necessary The monitor will prompt you to apply the sample to the test strip Questions Refer to Page 10 10 for Technical
94. t to continue to the bos Type Test Type Glucose Critical Range uc re screen Action Range Disabled Heut 5 If Ketone testing is enabled press 1 Next jo pes to continue to the Test Type Ketone Critical Range Action Range screen otherwise press Disabled 1 Next to continue to the Test Setup menu Heut Test Tupe 6 Press 1 Next to continue to the Ketone Test Type Ketone Critical Range screen Action Range Disabled Heut Test Tupe 7 Press 1 Next to continue to the Ketone Test Setup menu Critical Range Disabled 1 Ment Questions Refer to Page 10 10 for Technical Support Instructions Chapter 8 Review Setup Review Test Setup for Patient Test Ay Note This section illustrates some representative settings Ifthe monitor does not display these screens please refer to Chapter 10 Troubleshooting What You See on the Display What You Do Comments 1 Press 1 for Test Setup Review Setup 1 Test Setup 2 System Status 2 Press 3 for Patient Test to continue to Test Setup the Patient Test Patient ID screen 1 All Tests 2 Test Type A Patient Test 4 Control Test T Securitu Patient Test 3 Press 1 Next to continue to the Patient Test Patient ID Truncation screen Patient ID Optional 1 30 digits 1 Heart 4 Press 1 Next to continue to the Patient Patient Test Test Comment Code If In Range Patient ID screen Truncation Firzt Lazt 1 Heut Patient Test 5 Press 1 Next to continue to the Pati
95. test strip package insert for specifications and detailed instructions for use Reasons Glucose Results May Be Higher Than Expected e Haematocrit is lower than the acceptable limit for the test strips as indicated on test strip package insert e Serum or plasma samples were used instead of whole blood e Venous blood tested in arterial capillary mode when using Precision PCx Plus Test Strips Reasons Glucose Results May Be Lower Than Expected e Haematocrit is higher than the acceptable limit for the test strips as indicated on test strip package insert e Hyperglycaemic hyperosmolar state with or without ketosis e Severe dehydration hypotension or shock e Water or alcohol remaining on the puncture site e Venous or arterial whole blood sample not tested within 30 minutes after collection e Arterial or capillary blood tested in venous mode when using Precision PCx Plus Test Strips Reasons Ketone Results May Be Higher Than Expected e Haematocrit is lower than the acceptable limit for the test strips as indicated on test strip package insert e Serum or plasma samples were used instead of whole blood Reasons Ketone Results May Be Lower Than Expected e Haematocrit is higher than the acceptable limit for the test strips as indicated on test strip package insert e Water or alcohol remaining on the puncture site If test results appear higher or lower than expected for reasons not described above please repeat the test using a new test
96. to 30 digits not all digits will fit on the display The monitor may also be set to truncate ignore leading trailing and or selected digits of the bar code L Note You must use the same strip lot for the entire panel when performing a Linearity Test Chapter 7 Linearity Test Q Questions Refer to Page 10 10 for Technical Support Instructions Q What You See on the Display Linearity Kit Sample Type 1 Glucose ketone Scan or Enter Linearity Kit Lot Hew Panel 456 789 uill replace Did Panel 1234456 1 ReEnter kit Lot Replace Panel Select Level 1 Level 1 1 z Level z 01 S Level 3 0 d Level 4 0 Lepe 5 0 amp IHew Panel What You Do 5 Select Glucose or D Ketone Linearity Panel 6 Scan or manually enter the CVC kit lot number via the keypad then press Enter 7 If the New Panel screen appears you may either Press 1 ReEnter Kit Lot Press 2 Replace Panel 8 Select the number of the level of the next test to be run If you press 6 for a New Panel the monitor will prompt you to confirm that you wish to replace the existing panel uestions Refer to Page 10 10 for Technical Support Instructions Comments If D ketone testing is disabled this screen will not appear LIN stands for Linearity If the CVC kit lot number that was entered is different from the previous one the monitor will prompt you to do one of two actions Either re enter the existing lo
97. tor ID prompt The minimum and maximum number between 1 and 30 of digits that are acceptable for the Operator ID With manual entry of the Operator ID determine whether a check digit is required modulus 10 or 11 Decide acceptable formats for the Operator ID bar code Refer to the Bar Code Specifications in Chapter 12 for available formats The monitor can truncate ignore the leading digits and or the last digits of an Operator ID The monitor can be set to select specific digits of an Operator ID The number of digits is configured in the data management system Patient Tests Patient ID Determine whether the Patient ID is required optional or not used for patient tests Define the Patient ID prompt The minimum and maximum number between 1 and 30 of digits that are acceptable for the Patient ID Permission for manual entry of the Patient ID Determine whether duplicate entry of a manually entered ID is required With manual entry of the Patient ID determine whether a check digit is required modulus 10 or 11 Decide acceptable formats for the Patient ID bar code Refer to the Bar Code Specifications in Chapter 12 for available formats The monitor can truncate ignore the leading digits and or the last digits of a Patient ID The monitor can be set to select specific digits of a Patient ID The number of digits is configured in the data management system Decide whether confirmation of the Patient ID required Determine how t
98. trip port Should blood or control solution come in contact with the port protector the monitor should be cleaned and dried and the port protector replaced Chapter 11 provides instructions for replacing the port protector uestions Refer to Page 10 10 for Technical Support Instructions Chapter 2 Using the Monitor eo Q Monitor Identification Each monitor has a unique serial number listed on the back of the device just below the battery compartment The Precision Xceed Pro Monitor also features an untextured area on the side of the device This 22 mm wide x 11 mm high 0 875 inch x 0 483 inch area allows a facility to apply a label with information pertaining to the monitor Please refer to Chapter 1 for an illustration of this feature Menu Tree When using the Precision Xceed Pro Monitor you will navigate between two main menus Test Mode and Menu Mode Test Mode is used to perform patient tests and control tests Menu Mode is used to review data perform linearity and proficiency tests and review the monitor configuration settings and status e g battery voltage The configuration options shown in Menu Mode must be configured using a data management system You can visually verify existing monitor settings but cannot change them The Menu Mode portion of the software is set up like a tree with various levels of sub menus The Precision Xceed Pro Menu Tree shown below illustrates the multiple sub menu layers Test Mode Menu
99. utside the monitor monitor to return to room temperature x 459 pae operating temperature range Testing Disabled 1 Enit Questions Refer to Page 10 10 for Technical Support Instructions Chapter 10 Troubleshooting eo When You Turn on the Monitor or During Use Symptom Error Message Explanation How To Respond Configuration Required 1 Turn Uff Last upload incomplete Kedock meter 1 Continue Meter Error The monitor is shipped from the factory without configuration This screen will appear the first time you turn on the monitor after receiving it An error has occurred during last data transfer This screen will appear when you turn on the monitor The monitor may have a problem that prevents it from operating properly One of several four digit error codes may be Use PrecisionWeb or other Abbott supplied software to configure the device to your specific institutions requirement prior to using the device Place the monitor into the docking station to complete the upload Once the monitor has successfully been docked the warning will disappear Or Press 1 to Continue testing 1 Turn off the monitor Turn it on and repeat the function 2 If the problem persists place the displayed These codes provide Abbott monitor in the docking station to nnnrn additional information about the problem update the configuration files 3 If the problem still persists record the 1 Turn tt fou
100. w for Linearity Data P 5 8 Poncen ML ci aE E E N 6 PN ey dl Elio a H 6 1 PPM TING lest P KetONe D e eie rai e 6 4 Linearity TOSt ce 7 Review SGUD M 8 Monor on A e a A E E E E A ee 8 1 aa 0 o MR o 5 A N 8 3 ato E e A N V E A E A E A A E A E eR pU I RUREEE 8 4 Review Test Sctup tor Test PO 8 5 Review Test Setup lor Patient LOSE sone otsdesncseaacens ated escuinastoraatet cscade ostacact sieniniai enoii ia ainiko i a aTa teen on dolo nep eS inkes dune 8 6 a a E O RSS E E ac E T E E P N T A da reos 8 7 Reventa 8 9 SO ES SI IL OOPS 8 11 Data Upload eMe rtr 9 DA a tee a casteunrees 9 2 IVI Ur elena tod Dore CULO 1G OP A EEE A 9 2 Enabling Dita Upload M o A o tacos reve EE 9 3 Q uestions Refer to Page 10 10 for Technical Support Instructions 10 TroubleshOOtIN O RTT T TETTE 10 Tzroubleshootne Patent Test RESUS octets iv i RUE Ud ha xD IDEM aea 10 1 Troubleshooting Out of Range Control Test Resulta anno NEIGE VEI DIO EPI NES cian 10 1 Troubleshooting Out or hanse Linearity Test
101. y This provides an opportunity to ensure that all the pixels are working correctly Press and hold this button for two seconds to turn the monitor off The monitor will automatically shut itself off after 4 minutes to conserve battery life This length of time for automatic shut off can be configured from 4 to 10 minutes following patient tests only Backlight Alphanumeric Press and hold this button for about 2 seconds to active the display backlight scan or Enter Press this button while manually entering data to toggle between numeric uppercase Patient ID alpha mode and lower case alpha mode during manual data entry When in alpha mode enter alpha characters on the screen by pressing the 2 through 9 buttons multipletimesto 0 cycle through the characters Enter a SPACE character in alpha mode by pressing the 1 key PATIENT fl The monitor displays which mode you are in with a lowercase uppercase alpha indicator in the lower right side of the display Clear Press this button to back up one space while entering alphanumeric information on the keypad This button is also used to return to a previous screen if necessary Menu Press this button to switch the monitor from Test Mode to Menu Mode These two modes are described in the next section When viewing configuration information in Menu Mode pressing this button one time will return to the top of the menu tree Pressing the button a second time will switch to Test Mode Enter
102. y Note Useonly the AC adapter supplied by Abbott Diabetes Care Use of any other adapter may cause serious damageto the docking station and to the Precision Xceed Pro Monitor while it is in the docking station Mounting Instructions The docking station may be mounted vertically if desired This operation is similar to mounting a telephone on the wall Wall Mount Instructions 1 Drill the holes to match to the wall mount 2 Place the wall mount on the wall and insert the four enclosed screws 3 Align the two holes in the dock station with the two mounting anchors 4 After aligning the holes press in and then down to secure the docking station Questions Refer to Page 10 10 for Technical Support Instructions Chapter 9 Data Upload e Enabling Data Upload The docking station has two ports located on the back an AC adapter port older docking stations only and a data transfer port lt The data transfer port connects the docking station to a variety of transfer options using the included serial cable A connection to the data management system may be established directly via a networked computer or via a terminal server These connections are illustrated in Figures 1 and 2 Serial Cable Figure 1 Data Upload via Direct Connection or Networked Computer 1 Connect the serial cable between the docking station data transfer port and the computer serial port 2 Ensure that the computer ha
103. you hear the tabs snap into place There should be no gap between the port protector and the monitor around the edges Battery Life The average alkaline battery life is approximately 60 days based on an average of 9 tests per day and monitor being shut off within 2 minutes of it not being used depending on bar code usage Battery life will vary based upon actual use Replacing the Batteries Use the following procedure to install new batteries in the Precision Xceed Pro Monitor The Precision Xceed Pro Monitor requires two 2 AA alkaline batteries or nickel metal hydride NiMH rechargeable batteries not supplied by Abbott Diabetes Care 1 Turn the Precision Xceed Pro Monitor off by pressing the On Off D button on the keypad 2 Turn the monitor over and remove the battery door 3 Pull the blue tab to remove the batteries Figure 1 4 Discard the used batteries in compliance with your local government regulations 5 Insert the new batteries on top of the strap using the and symbols in the battery compartment to position the new batteries with the correct polarity Refer to Figure 2 below 6 Align the battery compartment cover with the slots on the Precision Xceed Pro Monitor then snap the cover into place IMPORTANT Rechargeable batteries must be at room temperature before they are placed in the battery compartment The docking station does not charge the batteries Figure 1 N Questions Refer to Page 10 10

POCT Precision Xceed Pro Operator`s Manual (mmol per L)

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