Abbott Precision XceedPro Operator`s manual
Contents
1. 15 Meter Replacement PIOGGOUIGues onu ton ite ticum user co quete ica E des Do qiu 05 oett Lan dco Mon Rap cU NM ON EDU DmImues a CUR ben DM Ec PUN OURUISMUE 19 Competency Assessment RENTE E NE 19 Product Information Reference Material vuusckistuinwukued usus utin dv adul SW uS cobi chers Madan qua Fb cunt bil uu Rd tat artic Rd 20 GOSS REICTE NCE G aurrie a i e u 20 Written By Gene Pagnani 5 03 Revised By Nancy Toscano MT ASCP Date 9 10 2010 Last Approved by Kim Gregory MT ASCP NCA CLS Date 9 12 11 Title with LTR Precision Xceed Glucose Procedure LTR19678 Last Approved Gregory Kimberly Electronic Signature Timestamp 8 11 2014 3 20 23 PM Purpose This document outlines policies and procedures that deal with the test being described In an effort to be concise some information may be excluded from the manufacturer s manual It is recommended that operators familiarize themselves with the manufacturer s product information that accompanies each package and their manual Scope Level of Personnel All MD s RNs NPs PCAs and TestStipPot AN MAs who have successfully completed initial training and A e maintained annual competency f Scanner Display Y Testing Site All sites approved and on file with the ae SS Bi Battery Pathology Service POCT Division Identification Space SIS w Compartment gy Ke2. 2 Contact nursing director for certification guidance 1 Contact nursing director for recertification directions 1 Press 1 to continue with testing 2 Run two levels of QC correctly before the number of days passes to maintain competency and access to the meter Press 2 Repeat Test 1 verify result by sending sample to lab 2 notify M D Press 2 Repeat Test 3 verify result by sending sample to lab 4 notify M D Press 1 to continue testing with a new test strip Repeat test If error continues to appear let meter sit for 24 hours and try again 1 Repeat test with a new test strip 2 Ifthe error appears again confirm the result by sending a sample to the laboratory 3 Contact Abbott technical support and give them the 4 digit error code 4 Contact POCT Coordinators How to Respond Unexpected Level Different level of control from the one Press 1 to repeat the test Low eupected that the monitor expected Press 2 to run the level of test that Hiah entered matches the lot number already entered 1 ReEnter Lot 2 Lontinue This screen shows the level of control test the monitor is expected to run Low or High and the level of the lot entered Troubleshooting When a Data Review is Selected Symptom Explanation How to Respond Error Message No Stored Tests No stored test results for the type of Press 1 to return to the Data Review data requested Menu 1 Exit
3. 2 Control Test Scan or Enter 3 Press Scan to scan the Operator ID After the Operator ID is entered the Operator ID barcode or manually enter the Low Level Solution Lot screen will Operator ID via the keypad then appear OPERATOR 4 Scan or manually enter the low The Strip Lot screen will appear next Scan or Enter control solution lot number via the Low Level k 7 eypad then press Enter Solution Lot Unexpected Level If the Unexpected Level screen appears the operator may either press Enter Low expected High entered 1 Enter 1 to test the correct level 2 Enter 2 to continue to test the 1 ReEnter Lot unexpected level 2 Continue Scan or Enter 5 Scan or manually enter the test strip After the test strip lot number is Strip Lot lot number via the keypad then entered the monitor will prompt for a press Enter test strip to be inserted into the test strip port Title with LTR Precision Xceed Glucose Procedure LTR19678 Last Approved Gregory Kimberly Electronic Signature Timestamp 8 11 2014 3 20 23 PM 6 Open the foil test strip packet at the notch and tear up or down to remove the test strip gt P 7 With the contact bars facing up The monitor will prompt the operator to insert the test strip into the test strip apply the desired control solution to port until it stops the test strip Apply Low 8 Verify that the QC solutions have The monitor will beep when the Solution not been opene
4. Adhere to hospital policy for proper patient identification utilizing two identifiers Scan the wristband linear barcode to capture the 9 10 digit CSN Collecting Capillary Blood Samples With meter ready obtain a sample Item Comment s Follow hand hygiene protocol and put on gloves Ask the patient to wash hands with warm soap and water rinse and dry well If the patient is unable cleanse the puncture site with an alcohol swab and allow to dry thoroughly Hold the patient s arm downward for at least 15 seconds to allow blood to flow to the fingertip Prick the side of the fingertip with an automatic Pricking the side of the fingertip is device or lancet generally less painful than the center of the fingertip Squeeze the finger gently to get a single large hanging drop of blood Avoid squeezing the puncture excessively Title with LTR Precision Xceed Glucose Procedure LTR19678 Last Approved Gregory Kimberly Electronic Signature Timestamp 8 11 2014 3 20 23 PM 6 Touch the blood drop to white target area at tip of test strip while the Apply Sample prompt appears in the display window Hold finger in place until test begins Never add additional sample Discard strip and use a new one if needed 7 If necessary the blood can be collected in a heparin coated capillary tube and then applied to the test strip within 30 minutes of collection Collecting Arterial Blood Samples With meter ready o
5. Jahn 6G 20 urcore 6 26 06 95r AM 1 Next Patient z Patient History p Smith John G E2 500 Glucose 06rz26 0T 7 36 AM 1 Hext Patient 2 Patient History Strip Error Wet or Damaged 1 New Strip 2 Exit Assay Error nnnn 1 Hew Strip 2 Enit The Operator ID just entered is not on the list of acceptable Operator ID s defined for this monitor The Operator ID entered has expired The menu item 2 Continue appear only if this option is set to Warn The operator ID entered expires in the shown number of days The test result is below the measuring limit of the system The test result is above the measuring limit of the system The test strip or the test port is wet defective contaminated or the wrong test strip was inserted There may be a problem with the test strip One of several 4 digit error codes may be displayed These codes provide Abbott personnel additional information about the problem Errors include 4327 The strip was removed during testing 4330 Blood glucose may be too high to be read by the system or there may be a problem with the test strip Troubleshooting When a Control Test is Selected Symptom Error Message Explanation Title with LTR Precision Xceed Glucose Procedure LTR19678 Last Approved Gregory Kimberly Electronic Signature Timestamp 8 11 2014 3 20 23 PM 1 Testing cannot continue because the Operator ID is not certified
6. X XX No stored test results match the Press 1 to return to the previous selected criteria screen 1 Frevious 6 2 Next 5 Troubleshooting During Data Transfer Symptom Explanation How to Respond Error Message Last upload Error has occurred during data 1 Remove the monitor from the incomplete transfer This screen will only appear docking station Kedock meter for three seconds 2 Place the monitor back into the docking station mE If the error appears again contact the l Continue POCT Coordinators Meter Replacement Procedure In the event of a problem with the meter the operator should 1 Review the troubleshooting section of this procedure 2 Contact the POCT Coordinators for assistance 6 1462 3 5392 or 4 8763 3 Email MGH POCT Coordinators 4 Contact the nursing supervisor for further assistance or additional issues on off shift or weekends Competency Assessment All operators must read the procedure manual and complete the Training and Competency Record for the Precision Xceed Pro Meter during initial training Competency is assessed at orientation and annually using at least two of the following methods 1 Successfully perform a low and high QC on the glucose meter 2 Supervisor observes performance of routine work 3 Each user s quality control performance is monitored 4 Written testing specific to the method Title with LTR Precision Xceed Glucose Procedure LTR19678 Last Approved Gregory
7. patient as well as allow the operator to view previous results Refer to the action entitled Data Review for Patient History for further information 14 After each use disinfect the meter with a disinfectant wipe Documentation The patient s results must be recorded in one of the following manners 1 in the patient s record or 2 ona patient log or 3 onanother approved permanent record All records must be retained and retrievable for 4 years Quality Control Critical Elements Please follow the recommended guidelines so the most accurate results will be obtained e Use only MediSense Precision Control Solutions e Store the control solutions at room temperatures between 39 and 86 F 4 and 30 C e Keep bottle caps fully tightened e Each bottle of control solution is stable for 90 days after opening e When a new bottle is first opened write the current date on the bottle label Discard all unused solutions 90 days after initial opening e 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 nozzle of the bottle e Donotscan one test strip packet s barcode and use a test strip from another packet since incorrect assay results may be generated e After each use replace the correct cap on each bottle and immediately tighten the cap e Do not use control solutions after the expiration date prin
8. NOTE The Critical Range screen will appear if the result is out of the critical range Repeat test to confirm result Notify M D Send specimen to laboratory Enter comment code NOTE The In Range Action Range screen will appear if the result is within this action range 12 Remove the test strip from the Title with LTR Precision Xceed Glucose Procedure LTR19678 Last Approved Gregory Kimberly Electronic Signature Timestamp 8 11 2014 3 20 23 PM Important If the test fails to start sufficient blood sample may not have been applied to the test strip Discard the current test strip and repeat with new strip The monitor counts down the 20 seconds it takes to analyze the sample then displays the test result If the result is above or below the action range an up or down triangle appears in front of the test result Comments monitor and discard when finished with testing ae 13 The operator can select one of the If 1 is selected the scan Patient ID p Smith John 6 ma i following options screen will appear Return to step 4 1 Sard to continue with testing on the next Glucose Press 1 Next Patient patient 06 26 0T 3 37 AM Press 2 Repeat Test i Hext Patient Press 3 Patient History If 2 is selected the scan or enter the 2 Patient History test strip lot screen will appear Return to step 5 to repeat the test If 3 is selected the monitor will display the last test result for this
9. Possible reasons are The red scanner beam did not pass across all the bars of the code The barcode was damaged or poorly printed The barcode was not of the lot or type specified for this ID or lot number The lot number just scanned or entered is not on the list of acceptable lot numbers defined for this monitor Contact the POCT Coordinators or Nursing manager for replacement meter Press 1 to exit Perform the control tests indicated in the message Press 1 to exit or if it appears press 2 to continue testing Place the monitor in the docking station Ensure that the room temperature is within the specified limits Press 1 to exit Remove the test strip from the test strip port 1 Re enter the patient 9 10 digit CSN using the barcode scanner or the keyboard 2 Contact the POCT Coordinators if the problem persists 1 Rescan the barcode If problem persists contact the POCT Coordinators 1 Verify and re enter the lot number using the barcode scanner 2 Manually enter the ID or lot number 3 Ifthe problem persists notify the POCT Coordinators Title with LTR Precision Xceed Glucose Procedure LTR19678 Last Approved Gregory Kimberly Electronic Signature Timestamp 8 11 2014 3 20 23 PM Operator ID 1234586753 Is Hot on the Operator List 1 ReEnter ID perator ID 23456799 Date Expired 1 FeEnter ID 2 Continue Operator ID Expires In nn Days 1 Continue p Smith
10. glucose monitoring systems Precautions e Ifthe test fails to start sufficient blood sample may not have been applied to the test strip Discard the current test strip and repeat with new strip Do not use during intravenous infusion of high dose ascorbic acid or during xylose absorption testing Do not use test strips after their expiration date Do not use test strips that are wet bent scratched or damaged in any way Do not re use test strips Action Ranges Patient Specimens Based on the performance characteristics of the instruments it is recommended that values less than 50 mg dL or greater than 400 mg dL be verified by sending specimen to the laboratory and notifying the physician Additionally in the neonatal population refer to preprinted order sheets for ranges and protocols and for diabetic patients refer to individualized sliding scale insulin orders Reference Range The normal range reported for plasma glucose collected in a gray top tube in a fasting patient is reported to be 70 100 mg dl Plasma glucose values are compared to the reference range in the context of criteria of the American Diabetes Association for the diagnosis of diabetes mellitus However we do not report a non fasting glucose level as this varies widely depending on a variety of factors Additionally the sample collected for blood capillary glucose is a capillary specimen which differs from the corresponding values of a plasma sample Therefore the
11. of birth Date amp time test collected performed and reported Ordering Physician Responsible physician if not 6 Reference or Target Range Test Performed Test units Lab name 2 3 4 9 6 f 8 9 1 1 Title with LTR Precision Xceed Glucose Procedure LTR19678 Last Approved Gregory Kimberly Electronic Signature Timestamp 8 11 2014 3 20 23 PM 3 Additional information that must be retained for four years 1 Testing personnel records 2 Quality control results 3 Product information i e serial number lot numbers expiration dates etc information on quality control and any remedial action 4 QC charts maintenance sheets reference and critical ranges 4 Other 1 Universal precautions must be observed when handling any patient specimen 2 Aphysician s order or standing order is required prior to performing test 3 The Hospital Hand Hygiene policy must be adhered to at all times Limitations Interferences 1 The Precision XceedPro Test Strips are designed for use with fresh whole blood samples DO NOT use serum or plasma samples The Hematocrit range is 20 709 Reportable range 20 500 mg dL sample size 0 6 ul test time 20 seconds Test results may be affected by various levels of severe hydration severely hypotensive in shock or in a hyperglycemic hyperosmolar state with or without ketosis Similar observations have been reported in the literature for other blood
12. section Documentation Data is automatically retained by the meter and transferred to the QC Manager Computer during meter docking Contact POCT Program for detail Data Review Patient History The Precision Xceed Pro Monitor stores up to 4 000 patient tests that can be retrieved by the following categories All Tests This option displays all patient test results starting with the most recent test results reverse chronological order Patient ID This will display the test results for a particular patient starting with the most recent test Operator ID This will show test results performed by a particular operator starting with the most recent test Action Range This will display the test results that fall outside of the action range Comment Code This shows the test results for all tests tagged with a specific comment code Date This will display all the test results for a specific date starting with the most recent test done on that date Data Upload Frequency Periodic as prompted by meter To begin data upload place the monitor in the docking station Once the connection is established communication between the monitor and the POCT Department PC will begin automatically The monitor can send and receive data When this occurs the monitor will display the following message Please wait for Data Upload Testing is preempted while the monitor is sending or receiving data Please Wait Data Uploading Th
13. 19678 Last Approved Gregory Kimberly Electronic Signature Timestamp 8 11 2014 3 20 23 PM Permanent Port Protector The blue 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 call the POCT Coordinators x61462 x35392 or x48763 to replace the monitor Specimen Collection Critical Elements Please follow the recommended guidelines so the most accurate results will be obtained Use the test strips before their expiration date Do not use test strips that are wet bent scratched or damaged Use the test strip immediately after opening its foil packet Do not scan a packet s barcode and use a test strip from another packet This may cause incorrect assay results to be generated Continue applying blood to the white target area of the test strip until the test begins Important If the test fails to start sufficient blood sample may not have been applied to the test strip Discard the current test strip and repeat with new strip After the blood is applied to the test strip and the test starts do not touch the test strip Use each test strip only once Specimen collection from an arterial line or use of liquid anticoagulants may result in false low readings because of dilution by line fluid or anticoagulants if care is not taken Follow hand hygiene protocol and wear gloves for all testing
14. BCG test does not correlate exactly with the plasma glucose level collected in a gray top tube Furthermore the CBCG test is designed for monitoring known diabetic patients in the hospital setting and is not indicated for the diagnosis of diabetes mellitus or related conditions The BCG value should be evaluated in the context of the individual patient their prior BCG glucose values underlying medical conditions pharmacological interventions and a variety of other patient specific criteria As a general guideline the reference range values are Adult fasting 70 140 mg dL Non fasting 70 200 mg dL Please refer to pediatric and neonatal protocols for reference ranges Title with LTR Precision Xceed Glucose Procedure LTR19678 Last Approved Gregory Kimberly Electronic Signature Timestamp 8 11 2014 3 20 23 PM Comment Codes Use optional COMMENT CODES No Action Required Repeat Test New Test Strip Box New Control Bottle Procedure Error New Test Strip Lot New Control Lot Changed Monitor Changed Batteries Repeat Test Notify Clinician and Send Sample to Lab 11 See Patient Record 15 Training OonN OOF WN CO Test Kits Supplies Equipment Product Manufacturer Distributed by MGH Storage PeopleSoft Glucose Precision Xceed Abbott 70932 01 Owens Minor 330220 39 86 C Pro strips 100 box Precision Glucose Control MediSense 498411 01 Owens Minor 39961 39 86 C Solution High Low one bo
15. Kimberly Electronic Signature Timestamp 8 11 2014 3 20 23 PM Documentation via Healthstream or other electronic program of all training competencies and attestations is acceptable in lieu of a paper record Expired Operators Operators that fail to meet competency requirements within 365 days will be locked out of the system They will be required to undergo retraining and competency assessment according to above Product Information Reference Material Abbott Precision Xceed Pro Manual Precision Xceed Pro blood glucose test strip package insert 07 08 Medisense glucose controls package insert 07 08 Glucose and b Ketone Calibration verification controls package insert 10 08 Website http www massgeneral org pathology assets poct MGH Precision Xceed Procedure approved pdf Cross References Precision Xceed Glucose Training and Competency Record Title with LTR Precision Xceed Glucose Procedure LTR19678 Last Approved Gregory Kimberly Electronic Signature Timestamp 8 11 2014 3 20 23 PM
16. POCT Program Massachusetts General Hospital Pathology Service 55 Fruit Street Boston MA 02114 Title Precision Xceed Glucose Procedure Cross References Precision Xceed Glucose Training and Competency Record MGH POCT QC Storage Ordering and Documentation Guide Glucose job aid Contents FD OSC m 2 ele MME 2 Poyan igo et AV ISIN PTT TE E Em 2 E c4udnue 2 FC OUIALONY FAC CUI C MI NETTE mem 2 ITT FNS WG Hh TIC ci ETE OE 3 ACHORO S TTE ET causes sohachenus LO Emm 3 FACTS FS CGO MNT 3 Comment Codes USE pptonal T 4 Hua mllee imeen ftee M 4 MAINONNAN CO ETT T H 4 serene 5 WSSU FOC MUG m PH 8 DOCUMEN AON RTT tens 11 SUMAS EN T c M 11 BUM mici iic RN T uu u 14 Rica ooo DONT V 14 Toup SINC nro MERE EE m E
17. btain a sample Item e Clear the arterial line before drawing a blood sample Withdraw blood sample into a syringe that contains sodium or lithium heparin e Caution You could obtain a false low glucose result if 1 sufficient flush is not withdrawn from the arterial line actual volume required to be removed is dependent upon length of line or 2 if liquid heparin is used to anticoagulate the sample and the ratio of blood to heparin is not controlled or not taken into consideration e Use the sample within 30 minutes of collection e Mix the syringe several times immediately before applying the sample to the target area on the test strip e Allow a drop of blood to form at the tip of the syringe Title with LTR Precision Xceed Glucose Procedure LTR19678 Last Approved Gregory Kimberly Electronic Signature Timestamp 8 11 2014 3 20 23 PM Comment s e Touch the blood drop to white target area at tip of test strip while the Apply Sample prompt appears in the display window Hold syringe in place until test begins The syringe can briefly touch the test strip without affecting the test result Never add additional sample Discard strip and use a new one if needed e Do not force blood into the strip from the syringe This may cause blood to enter the port protector and damage the meter Collecting Venous Blood Samples With meter ready obtain a sample Item Comment s e Collect the
18. d for more than 90 sample is accepted The sample days Gently invert the required accepted screen will be displayed control solution bottle 3 4 times then apply a drop to the target area on Recap the contract solution bottle the test strip tightly The test starts automatically as the sample is accepted 9 Wait for the monitor to analyze the The monitor counts down the seconds Analyzing control solution and display the test it takes to analyze the sample 20 Sample results seconds then displays the test result Low 10 Control results appear as either PASS PASS or FAIL Gl ucoze OQe6 z2e6 0r 10 06 AM 1 Hext Level Z Repeat Test Low 34 64 11 If the control result appears as FAIL X mr scan or manually enter a comment 9 fma dL code via the keypad then press blucose Enter Scan or Enter Comment Code 12 Remove the test strip and discard Title with LTR Precision Xceed Glucose Procedure LTR19678 Last Approved Gregory Kimberly Electronic Signature Timestamp 8 11 2014 3 20 23 PM Low 13a After low control has been PASS successfully performed press 1 Glucose Next Level and repeat steps 4 12 06 26 07 10 06 RM using high control 1 Next Level 2 Repeat Test 13b If high control fails enter comment code press Enter and repeat test 14a When both levels PASS the analyzer is ready for patient testing 14b If one or both levels continue s to fail take remedial action see appropriate
19. e Results May Be Higher than Expected e Hematocrit is lower than 20 e Serum or plasma samples instead of whole blood e Venous blood tested in arterial capillary mode e Additional sample added to test strip during testing Reasons Glucose Results May Be Lower than Expected e Hematocrit is higher than 70 Arterial or capillary blood tested in venous mode Patient has hyperglycemic hyperosmolar with or without ketosis Patient has severe dehydration hypotension or shock Water or alcohol remaining on the puncture site Venous or arterial blood sample not tested within 30 minutes after collection B Troubleshooting Out of Range Control Solution Results Repeat the test for that control solution to make sure that the operator meets the conditions in this checklist e No air bubbles are in the control bottle s nozzle Calibration performed using the bar code for the test strip used Correct 5 digit lot number for the control solutions Solutions and test strips stored between 39 F and 86 F 4 C and 30 C Temperature and humidity conditions in the room where the tests are being performed are within the acceptable operating range Refer to the Precision Xceed Pro Test Strip Package insert Bottles have not been open for more than 90 days Only Precision Xceed Pro Test Strips used If test results are out of range despite meeting the above criteria please repeat the test using a new box of control solutions and or test strips If the resul
20. e monitor must not be removed before data transmission is completed otherwise data transfer will be incomplete and operator access may be affected Title with LTR Precision Xceed Glucose Procedure LTR19678 Last Approved Gregory Kimberly Electronic Signature Timestamp 8 11 2014 3 20 23 PM Docking Station The Precision Xceed Pro System docking station provides a means for hands free automatic data transfer upload download between the Precision Monitor and a server in the Partners server farm running the QC Manager Application software The lantronix box must be connected to a power source via the AC adapter supplied with the docking station Once the monitor is placed into the docking station and a connection is established data will be automatically transferred RJ 45 Network Cable y S Terminal Server ee ee RS 23 Communications d m Cable The circulating arrow displayed on the meter s LCD screen indicates data transfer upload download is in process Do not remove meter until the arrow disappears and the menu is displayed Troubleshooting A Troubleshooting Out of Range Patient Test Results This section describes conditions that can cause out of range patient test results Refer to the Precision Xceed Pro Test Strip package insert for test strip specification information NOTE Do not use during intravenous infusion of high dose ascorbic acid or during xylose absorption testing Reasons Glucos
21. en will appear when station to complete the upload Redock meter you turn on the monitor Once the monitor has successfully been docked the warning will disappear 1 Continue Or Press 1 to Continue testing Title with LTR Precision Xceed Glucose Procedure LTR19678 Last Approved Gregory Kimberly Electronic Signature Timestamp 8 11 2014 3 20 23 PM Configuration Required 1 Turn Off Low High Control Test Required 1 Euit 2 Continue Test Memory Upload Required 1 Exit 2 Continve Temperature Outside Range 43 9 C Testing Disabled ate Remove Strip Scan or Enter Patient ID Invalid ID Strip Lot Scan or Enter Strip Lot Invalid Lot Barcode Strip Lot 0350136401 70502 Is Not on the Strip Lot List 1 ReEnter Lot 2 Continue The monitor is shipped from the factory without configuration This screen will appear the first time you turn on the meter after receiving it QC Interval for Controls Exceeded Controls must be performed before testing The Upload Interval Exceeded The room temperature is outside the limits for testing The test strip was inserted at the wrong time The monitor will beep if functions are 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 The scanned Patient 9 10 digit CSN is similar in format to the test strip barcode The barcode just scanned was not read correctly
22. lary z Menous 7 Open the foil test strip packet at the notch and tear up or down to remove the test strip Test Procedure Continued What You See on the What You Do Comments Display 8 With the contact bars facing up The Apply Sample screen will appear insert the test strip into the test next strip port until it stops Apply 9 Touch the blood drop to white Apply the blood directly from the Sample target area at tip of test strip patient s finger or a syringe to the while the Apply Sample test strip filling the entire white target rompt appears in the displa olds uiuit PP p ay The test starts automatically as the sample is accepted Title with LTR Precision Xceed Glucose Procedure LTR19678 Last Approved Gregory Kimberly Electronic Signature Timestamp 8 11 2014 3 20 23 PM Analyzing Sample 20 aAction Range 420 Ta Slucose Scan or Enter Comment Code a Critical Range 400 Glucose Scan or Enter Comment Code Test Procedure Continued What You Do What You See on the Display 105 240 Glucose Scan ar Enter Comment Code 10 Wait for the monitor to analyze the sample and display the result 11 Note the result and whether it falls outside the action range NOTE The Outside Action Range screen will appear if the result is out of the action range Repeat test to confirm result Notify M D Send specimen to laboratory Enter comment code
23. le 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 including the three digit error code if any and call Abbott Technical Support 1 877 529 7185 Nursing POCT Program Manager 617 724 8763 for PCS sites Pathology POCT Program Coordinators 617 726 1462 617 643 5392 for PCS and other sites Email MGH POCT Coordinators Troubleshooting When You Turn on the Meter or During Use Symptom Explanation How to Respond Error Message The monitor has little or no power Place the monitor into the docking station to recharge the battery or change battery The display is blank Battery power is getting low Testing will Replace with 2 AA batteries i be available for a limited time Low Battery 1 Turning Uff The monitor may have a problem that 1 Turn off the monitor Turn it on prevents if from operating properly One and repeat the function of several four digit codes may be Meter Error ae displayed These codes provide Abbott 2 Ifthe problem persists record additional information about the problem the three digit error code and 1 Turn Off contact the POCT program manager for new meter Last upload An error has occurred during last data Place the monitor into the docking Incomplete transfer This scre
24. ted on the bottles and the box The Precision Xceed Pro Monitor does not accept control solutions that have passed their expiration date Frequency e Two levels low and high every 24 hours when meter is in use for patient testing Meter is locked out from patient testing if QC fails or is not performed Malidates instrument performance and proper operator technique Title with LTR Precision Xceed Glucose Procedure LTR19678 Last Approved Gregory Kimberly Electronic Signature Timestamp 8 11 2014 3 20 23 PM Successful performance will recertify operator competency for an additional 12 months e When you question blood glucose results e When your test strips have been exposed to temperatures outside the storage conditions 39 86 F 4 30 C Quality Control Test Procedure Use the following procedure to perform control tests Note The word Strip on the display always refers to the test strip If the monitor displays a message not indicated in these procedures please refer to section 10 Troubleshooting in the Precision Xceed Pro Operator s Manual What You See on the What You Do Comments Display 1 Press On Off to turn on the monitor The Abbott logo screen will appear for a few seconds followed by the product name software version and then the Test Mode menu 2 Press 2 Control Test After control test is selected the 06 26 07 9 02 RM Operator ID screen will appear imm 1 Patient Test
25. the What You Do Comments Display 1 Press on off to turn on monitor The Abbott logo screen will appear for a few seconds followed by the product name software version screen and then the Test Mode menu 2 Press 1 to select Patient Test After the operator selects the type of 06 26 07 9 02 AM test the display will prompt for an inm Operator ID to be entered 1 Patient Test 2 Control Test Scan or Enter 3 Press Scan to scan the Operator ID The display will next prompt for a Operator ID barcode or manually enter the Patient ID to be entered Operator ID via the keypad then press Enter OPERATOR Scan or Enter 4 Press Scan to scan the Patient 9 10 After entering the Patient ID the test Patient ID digit CSN barcode or manually strip lot screen appears next enter the Patient 9 10 digit CSN via ae Se the keypad then press Enter PATIENT Title with LTR Precision Xceed Glucose Procedure LTR19678 Last Approved Gregory Kimberly Electronic Signature Timestamp 8 11 2014 3 20 23 PM Sean or Enter 5 Press Scan to scan the test strip After the test strip lot number has Strip Lot barcode or manually enter the test been entered the Sample Type strip lot number via the keypad then screen will appear press Enter Enter 6 Press 1 for Capillary or Arterial Selection will ensure that the Sample Type specimens specimen result will take into consideration specimen PO Press 2 for Venous specimens 1 Arterial Capil
26. ts are still out of range call Abbott Technical Support 1 877 529 7185 Nursing POCT Program Manager 617 724 8763 for PCS sites Pathology POCT Program Coordinators 617 726 1462 617 643 5392 for PCS and other sites Title with LTR Precision Xceed Glucose Procedure LTR19678 Last Approved Gregory Kimberly Electronic Signature Timestamp 8 11 2014 3 20 23 PM Email MGH POCT Coordinators C Discrepancies between Xceed Pro and Laboratory Discrepancies noted between the Xceed Pro monitor and the Laboratory should be investigated It is important to note that the samples must be drawn at the same time or within a few minutes of each other to have a valid comparison as blood glucose values can change quickly depending on the clinical condition of the patient Accuracy of the glucose results from a meter is considered acceptable if the glucose is within 15 mg dL for results less than 75 mg dL or 20 for glucose results greater than 75 mg dL Nursing POCT Program Manager 617 724 8763 for PCS sites Pathology POCT Program Coordinators 617 726 1462 617 643 5392 for PCS and other sites Email MGH POCT Coordinators D Symptom Error Messages In this section you will find information relating to error messages that appear on the display when errors are detected by the Precision Xceed Pro Monitor For each corresponding message an explanation is given and appropriate responses are described In many situations it may be possib
27. ttle of each box Glucose and Ketone Abbott 70906 01 N A Special request 36 86 C Calibration verification Controls 5 levels POCT program use only 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 Disinfecting the Exterior Surface Disinfecting the exterior surface of the Precision Xceed Pro Monitor is required after each use The monitor needs only to be wiped down after use with hospital approved disinfectant It is suggested that the monitor be turned off while it is being cleaned DO NOT immerse flood with any liquid or autoclave the monitor Disinfecting after use need not be documented since this is part of the operating procedure Replacing the Batteries used for replacing alkaline batteries Use the following procedure to install new batteries in the Precision Xceed Pro monitor The Monitor requires two 2 AA alkaline batteries Turn the Xceed Pro Monitor off by pressing the On Off button on the keypad Turn the monitor over to view the battery compartment Press the tab on the battery compartment cover and lift the cover up Remove and discard the used batteries Insert the new batteries using the and symbols in the battery compartment to position the new batteries with the correct polarity en e Dus Title with LTR Precision Xceed Glucose Procedure LTR
28. venous blood sample in a collection tube containing sodium or lithium heparin ensuring that the test tube is completely filled e Do not use collection tubes that contain fluoride or oxalate e lf the blood is collected from an intravenous line clear the line before drawing the sample into a syringe that contains sodium or lithium heparin Allow the sample to reach room temperature before performing a test on the sample use the sample within 30 minutes of collecting it e Invert the tube with the sample several times immediately before taking a sample e Use adisposable transfer pipette to obtain a sample from the center of the collection tube e Touch the blood drop to white target area at tip of test strip while the Apply Sample prompt appears in the display window Hold pipette in place until test begins The pipette can briefly touch the test strip without affecting the test result Never add additional sample Discard strip and use a new one if needed Title with LTR Precision Xceed Glucose Procedure LTR19678 Last Approved Gregory Kimberly Electronic Signature Timestamp 8 11 2014 3 20 23 PM Test Procedure Use the following procedure to perform patient tests Note The word Strip on the display always refers to the test strip If the monitor displays a message not indicated in these procedures please refer to section 10 Troubleshooting of the Abbott Precision Xceed Pro manual What You See on
29. ypad D JJ TS Number Data Port Policy and Principle Statement e To obtain a quantitative measure of blood glucose measurement that is used definitively for the purpose of care Test Principle The Precision Xceed Pro System allows rapid measurement of blood glucose D glucose by using an electrochemical detection technique This biosensor system employs a disposable dry reagent strip technology based on the glucose dehydrogenase method for glucose determination Each test strip features an electrode containing the enzyme glucose dehydrogenase GDH NAD When a blood drop is applied to the target area of the test strip the glucose dehydrogenase catalyzes the oxidation of glucose in the drop to produce gluconic acid During the reaction electrons are transferred by a co enzyme and an electrochemical mediator to the electrode surface This will generate a current that is measured by the system The size of the current generated is proportional to the amount of glucose present in the blood drop thus giving an accurate reading of the blood glucose concentration Regulatory Requirements 1 Each testing site must have a documented quality control program which is developed in collaboration with or has been approved by the MGH Pathology Service 2 All test results must be maintained in patient records with all required information for four years Required information 1 Patient s name MRN number Patient s gender Patient s age or date
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