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12-5

Questions? Refer to Page 10-10 for Technical Support Instructions.

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 A1: 1993, A11: 1993, A12: 1993, A2: 1995 and A13: 1996; IEC 601-1: 1988 + A1: 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 Requirements 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).

Chapter 12: Specifications/Limitations

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Содержание Precision Xceed Pro

Страница 1: ...pective owners This product s and or its use are protected by one or more of the following patents US5 509 410 US5 628 890 US5 727 548 US6 129 823 US6 592 745 US6 607 658 US6 736 957 US6 764 581 US6 939 450 US6 377 894 US6 600 997 US6 773 671 US5 682 884 USD7 077 328 USD411 989 USD413 537 USD557 422S US6 591 125 US7 058 437 EP1 009 850B1 EP1 119 637B8 EP1 023 455B1 and EP1 012 326B1 Additional pat...

Страница 2: ... Capillary Blood Sample 3 2 How to Obtain a Venous Blood Sample 3 2 How to Obtain an Arterial Blood Sample 3 2 How to Obtain a Neonatal Capillary Blood Sample 3 2 Disposing of Waste 3 2 Patient Test Procedure Glucose 3 3 Patient Test Procedure β Ketone 3 7 4 ControlTest 4 Operating Guidelines for Control Solution Testing 4 1 Control Test Procedure Glucose 4 2 Control Test Procedure β Ketone 4 5 5 ...

Страница 3: ...Range Linearity Test Results 10 2 Error Messages 10 2 Technical Support Instructions 10 10 Returning an Instrument 10 10 Contacting Abbott for Service 10 11 11 Maintenance 11 Cleaning the Exterior Surface 11 1 Replacing the Port Protector 11 2 Battery Life 11 2 Replacing the Batteries 11 2 12 Specifications 12 Precision Xceed Pro Monitor 12 1 Symbols 12 2 Bar Code Types 12 3 Important Safety Instr...

Страница 4: ...1 Overview Intended Use TrueID TrueMeasure and TrueAccess Icons and Warnings Conventions System Components ...

Страница 5: ...tor identification data entry scanned versus manually entered on the keypad to help Point of Care Coordinators identify and correct errors TrueMeasure Fast Simple Testing To perform a test simply insert a strip into the monitor s 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...

Страница 6: ...d Note Providesorreferstheoperatortoadditionalorbackgroundinformationthatmaybehelpfultothem 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...

Страница 7: ... available separately At the top of the monitor is the test strip port covered by the port protector The port protector is designed to minimize liquid entering the monitor through the strip port Chapter 11 provides instructions for changing the protector 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 ...

Страница 8: ...hentheteststripisoutofthemonitor Donotusewet bent scratchedordamagedteststrips 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 expi...

Страница 9: ...s 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 transparent cover allows you to check supply status without opening the case Docking Station optional The docking station provides a convenient way to upload the data from the monitor to the data...

Страница 10: ...2 Using the Monitor Bar Code Scanner Data Entry Keypad Audible Indicator Data Port Battery Compartment Port Protector Monitor Identification Menu Tree ...

Страница 11: ... 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 will automatically proceed to the next screen The scanning beam shuts off in three seconds if nothing is detected Data Entry Keypad The data entry keypad allows you to enter identification nu...

Страница 12: ... top of the menu tree Pressing the button a second time will switch to Test Mode Enter 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...

Страница 13: ...e 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 s configuration settings and status e g battery voltage The configuration options shown in Menu Mode must be configured using a data ...

Страница 14: ...ing 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 β Ketone ...

Страница 15: ...rips 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...

Страница 16: ...th blood How to Obtain an Arterial Blood Sample Us e only fresh whole blood samples Clear the arterial line before drawing a blood sample into a heparinized syringe Use the sample within 30 minutes of collection Mix the blood specimen well immediately before applying the sample to the target area of the test strip Allow a drop of blood to form at the tip of the syringe Apply a drop of blood to the...

Страница 17: ...appear 2 Press 1 to select PatientTest The monitor starts in Test Mode The Menu button will toggle the monitor to Menu Mode 3 Press Scan to scan the Operator ID bar code or manually enter the Operator ID via the keypad then press Enter While the Operator ID may be up 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 ...

Страница 18: ...ess Enter 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 7 If using Precision PCx Plus Test Strips the SampleType screen may appear You can select one of the following Press 1 Arterial Capillary or Press 2 Venous Use Venous mode only for ve...

Страница 19: ...t stops and Strip Inserted is displayed 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 10 Apply a drop of blood from the patient s finger transfer pipette or syringe to the target area of the test strip When sufficient sample has been applied the monitor beep...

Страница 20: ...r further information 105 mg dL IMPORTANT Ifthebloodglucoseresultappearstobeinconsistent lowerorhigherthanexpected there maybeaproblemwiththeteststrip Repeatthetestusinganewteststrip Resultsthatare incorrectmayhaveseriousmedicalconsequences Consulttheprescribingphysicianbefore makinganychangestodiabetesmedicationplansif ThebloodglucoseresultsarenotconsistentwiththephysicalsymptomsAND youhaveruledo...

Страница 21: ...refer to the Test Strips section of Chapter 1 3 Wait for the monitor to analyze the sample and display the test result 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 4 If prompted scan or manually enter the comment code an...

Страница 22: ...4 Control Test Operating Guidelines for Control Solution Testing Control Test Procedure Glucose Control Test Procedure β Ketone ...

Страница 23: ...ion is stable for 90 days after opening or until the expiry date printed on the label whichever comes first Do not use 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 Invert and tap the capped contr...

Страница 24: ...lly enter the Operator ID via the keypad then press Enter While the Operator ID may be up 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 4 Scan or manually enter the low control solution lot number via the keypad then press Enter You can scan or manually enter the information from the contro...

Страница 25: ... 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 8 Gently invert the required control solution bottle 3 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 ...

Страница 26: ...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 facility s biohazard disposal policy The display shows Level Low Mid High Comment Code Number in box Test Type Glucose Date and Time of test Operator ID o prompt...

Страница 27: ...ce the assay begins all key presses are ignored until the assay is completed 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 Control test results can appear as numeric or PASS FAIL depending on how the test is set up If numeric an X will appe...

Страница 28: ...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 ...

Страница 29: ...ow proficiency test results starting with the most recent test Linearity Data This will show linearity test results by level and order Data Review Note ThemonitormaybeconfiguredtorequireavalidOperatorIDtoviewresults Chapter 5 Data Review What You See on the Display What You Do Comments Note Thefollowingsectionillustratessomecommonsettings Dependingonyourinstitution sspecificsettings somescreenswil...

Страница 30: ...perator ID via the keypad then press Enter While the Operator ID may be up 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 5 Choose the category of data to review What You See on the Display What You Do Comments Chapter 5 Data Review ...

Страница 31: ...e result of the most recent patient test you performed 2 You can select one of the following options Press 1 Previous Press 2 Next When finished reviewing the data you can Press Clear to return to the Data Review menu Press Menu to return to the Menu Mode menu Press On Off to turn off the monitor The number that appears to the right of 1 Previous and 2 Next on the monitor indicates the number of t...

Страница 32: ...ient ID entry screen Press Menu to return to the Menu Mode menu Press On Off to turn off the monitor The number that appears to the right of 1 Previous and 2 Next on the monitor indicates the number of tests available for review The display also shows Patient ID or Name p prompt Comment Code Number in box Test Type Glucose or Ketone Date and Time of test Operator ID o prompt Note that test date an...

Страница 33: ...indicates the number of tests available for review The display also shows Patient ID or Name p prompt Comment Code Number in box Test Type Glucose or Ketone Date and Time of test Operator ID o prompt Note that test date and time alternates with Operator ID What You See on the Display What You Do Comments Data Review for All Patient Data Please refer to the beginning of this Data Review chapter for...

Страница 34: ...play also shows the acceptable range for this test and Comment Code Number in box Level Low Mid High Range if numeric Test Type Glucose or Ketone Date and Time of test Operator ID o prompt Note that test date and time alternates with Operator ID What You See on the Display What You Do Comments Data Review for Control Data The monitor stores the last 1 000 control test results Please refer to the b...

Страница 35: ...or review The display shows the following Sample ID s prompt Comment Code Number in box Test Type Glucose or Ketone Date and Time of test Operator ID o prompt Note that test date and time alternates with Operator ID What You See on the Display What You Do Comments Data Review for Proficiency Data The monitor stores the last 20 proficiency test results Please refer to the beginning of this Data Rev...

Страница 36: ...Next on the monitor indicates the number of tests available for review The display shows the following Level 1 to 5 Test replicate 1 to 4 Comment Code Number in box Test Type Glucose or Ketone Date and Time of test Operator ID o prompt Note that test date and time alternates with Operator ID What You See on the Display What You Do Comments Data Review for Linearity Data The monitor stores the last...

Страница 37: ...6 Proficiency Test Proficiency Test Glucose Proficiency Test β Ketone ...

Страница 38: ...n will briefly appear 2 Press the Menu button The monitor starts in Test Mode The Menu button will toggle the monitor to Menu Mode 3 Press 3 to select Proficiency Test 4 Press Scan to scan the Operator ID bar code or manually enter the Operator ID via the keypad then press Enter While the Operator ID may be up to 30 digits not all digits will fit on the display The monitor may also be set to trunc...

Страница 39: ... has been approved for use by your institution 7 Open the foil test strip packet at the notch and tear down to remove the test strip With clean dry hands you may gently touch the test strip anywhere when removing it from the foil to insert it into the monitor 8 With the contact bars facing up insert the test strip into the test strip port until it stops and Strip Inserted is displayed Prior to ins...

Страница 40: ...ror 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 11 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 The monitor may be enabled to scan or enter a 1 to 2 digit comment code 12 You can select one of th...

Страница 41: ... monitor to analyze the sample and display the test result 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 4 If required scan or manually enter the comment code and press Enter If there is no prompt to enter a comment code ...

Страница 42: ...7 Linearity Test ...

Страница 43: ...Verification Control CVC kit These kits contain assayed materials for use in confirming the calibration and linearity of glucose and β 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 types and detailed instructions for use Please u...

Страница 44: ...different from the previous one the monitor will prompt you to do one of two actions Either re enter the existing lot number or replace the existing lot number with the new lot number 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 There can be up to 4 replicates per level ...

Страница 45: ...s been approved for use by your institution 10 Open the foil test strip packet at the notch and tear down to remove the test strip With clean dry hands you may gently touch the test strip anywhere when removing it from the foil to insert it into the monitor 11 With the contact bars facing up insert the test strip into the test strip port until it stops and Strip Inserted is displayed Prior to inse...

Страница 46: ...or manually enter the comment code and press Enter If there is no prompt to enter a comment code skip down to step 15 The monitor may be enabled to scan or enter a 1 to 2 digit comment code 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 d...

Страница 47: ...p 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 ...

Страница 48: ...atient 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 ...

Страница 49: ...isplays results in mmol L or mg dL Glucose only Decide whether any additional free text comments are stored with a test record These can be required optional or not used Decide whether to configure the monitor for proficiency tests Decide whether to configure the monitor for linearity tests Determine what language such as English displays on the monitor Turn the audible indicator off on Configure ...

Страница 50: ...s 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 Menu Mode 3 Press 2 to select Review Setup Chapter 8 Review Setup What You See on the Display What You Do Comments Review Setup Note Thissectionillustratessomerepresentativesettings Ifthemonitordoesnotdisplaythesescreens pleaserefer...

Страница 51: ...een 4 Press 1 Next to continue to the All Tests Operator ID Truncation screen 5 Press 1 Next to continue to the All Tests Operator ID Prompt screen 6 Press 1 Next to return to the Test Setup menu Chapter 8 Review Setup What You See on the Display What You Do Comments Review Test Setup for All Tests Note Thissectionillustratessomerepresentativesettings Ifthemonitordoesnotdisplaythesescreens pleaser...

Страница 52: ...n 5 If Ketone testing is enabled press 1 Next to continue to the Test Type Ketone Action Range screen otherwise press 1 Next to continue to the Test Setup menu 6 Press 1 Next to continue to the Test Type Ketone Critical Range screen 7 Press 1 Nexttocontinuetothe Test Setup menu Chapter 8 Review Setup What You See on the Display What You Do Comments Review Test Setup for Test Type Note Thissectioni...

Страница 53: ...reen 5 Press 1 Next to continue to the Patient Test Comment Code If Out of Range screen 6 Press 1 Next to continue to the Patient Test Patient ID Prompt screen 7 Press 1 Next to continue to the Patient Test Repeat Manual ID Entry screen 8 Press 1 Next to return to the Test Setup menu Chapter 8 Review Setup What You See on the Display What You Do Comments Review Test Setup for Patient Test Note Thi...

Страница 54: ...xt to continue to the Control Test Ketone Levels screen otherwise press 1 Next to skip down to step 7 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 Chapter 8 Review Setup What You See on the Display What You Do Comments Review Test Setup for Control Test Note Thissectionillustratessomerepresentativ...

Страница 55: ... Questions Refer to Page 10 10 for Technical Support Instructions 7 Press 1 Next to continue to the Control Test Comment Code If Out of Range screen 8 Press 1 Next to return to the Test Setup menu Review Test Setup for Control Test Chapter 8 Review Setup ...

Страница 56: ... Next to skip down to step 5 4 Press 1 Next to continue to the Security Operator ID Not Certified screen 5 Press 1 Next to continue to the Security Strip Lot Not on List screen 6 Press 1 Next to continue to the Security Patient Data Not Confirmed screen Chapter 8 Review Setup What You See on the Display What You Do Comments Review Test Setup for Security Note Thissectionillustratessomerepresentati...

Страница 57: ...uctions 7 Press 1 Next to continue to the Security Confirm Patient Data screen 8 Press 1 Next to return to the Test Setup menu Review Test Setup for Security Note Thissectionillustratessomerepresentativesettings Ifthemonitordoesnotdisplaythesescreens pleaserefertoChapter10 Troubleshooting Chapter 8 Review Setup ...

Страница 58: ...pear 2 Press the Menu button The monitor starts in Test Mode The Menu button will toggle the monitor to Menu Mode 3 Press 2 select Review Setup 4 Press 2 to continue to the System Status Battery Power screen 5 Press 1 Next to continue to the System Status Temperature screen Chapter 8 Review Setup What You See on the Display What You Do Comments System Status Note Thissectionillustratessomerepresen...

Страница 59: ...o continue to the System Status Date screen 8 Press 1 Next to continue to the System Status Software Version and Serial Number screen 9 Press 1 Next to continue to the Review Setup menu The number that appears on your monitor may be different from the number that appears here Chapter 8 Review Setup What You See on the Display What You Do Comments ...

Страница 60: ...9 Data Upload Docking Station Mounting Instructions Enabling Data Upload ...

Страница 61: ... is complete the monitor will display Upload Successful Turning Off and then shut down Note Ifthemonitorisremovedbeforedatatransmissioniscomplete somedatamaynotbeuploaded Thedatawillbeuploadedaspartofthenextdatatransmission 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...

Страница 62: ...station is connected to a power supply 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 The AC Adapter is not required If the AC adapter is not used data transfer will still occur but the LEDs will not light up Note UseonlytheACadaptersuppliedbyAbbottDiabetesCare Useofany...

Страница 63: ... has 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 Figure 2 Data Upload viaTerminal Server 1 Connect the terminal server AC adapter to a power source 2 Connect the serial cable to the t...

Страница 64: ...ooting 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 ...

Страница 65: ...r lower than expected for reasons not described above please repeat the test using a new test 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...

Страница 66: ...s 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 Check CVC bottle for open bottle expiry date Use a new test strip for each test Use only P...

Страница 67: ...Abbott additional information about the problem 1 Turn off the monitor Turn it on and repeat the function 2 If the problem persists place the monitor in the docking station to update the configuration files 3 If the problem still persists record the four digit error code and contact Abbott Technical Support The monitor has detected a problem with the barcode scanner that would prevent the scanner ...

Страница 68: ...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 1 If Ketone QC Due in xx min is displayed no action is required Ketone testing can proceed 2 If Ketone QC Due Now is displayed then Ketone QC testing per your facility s procedures may be required before proceeding with a ketone test 3 C...

Страница 69: ...be uploaded before testing starts 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 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...

Страница 70: ...ith a new unexpired foil packet of test strips 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 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 The ID or lot number just scanned or entered is not on the list of acceptable ID s o...

Страница 71: ... 1 Press 1 to Re Enter the Operator ID 2 If the problem persists contact the system administrator for further information on operator certification The Operator ID entered has expired The menu items 1 ReEnter ID and 2 Continue appear only if this option is set to Warn 1 Press 1 to re enter the ID using the bar code scanner or keypad Or Press 2 to Continue testing 2 If the problem persists notify t...

Страница 72: ... to continue testing with a New Strip Or Press 2 to Exit to the Test Menu 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 1 Press 1 to repeat the test with a New Strip or 2 to Exit 2 If the error occurs again record the 4 digit error code and contact Abbott Te...

Страница 73: ...arity 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 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 ...

Страница 74: ...he 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 pote...

Страница 75: ...lschaft m b H Abbott Diabetes Care Vienna Austria Tel 0800 930 093 Belgium and Luxembourg Abbott S A N V 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 800 189 564 Denmark Abbott Laboratories A S Abbott Diabetes Care København Ø Denmark Tel 80 81 53 54 Finland Ab...

Страница 76: ...betes Care Col Ex Hacienda Coapa Mexico Tel 01 800 711 2208 Peru Abbott Laboratorios de Peru Abbott Diabetes Care Lima Peru Uruguay Biocare S A Montivideo Uruguay Tel 0800 8564 Venezuela Abbott Laboratorios C A Abbott Diabetes Care Caracas Venezuela Tel 0800 458 2672 0 800 Glucosa MIDDLE EAST AND AFRICA Turkey Tel 0800 261 75 04 Saudi Arabia Abbott Diabetes Care Mediserv Riyadh Saudi Arabia Tel 80...

Страница 77: ...11 Maintenance Cleaning the Exterior Surface Replacing the Port Protector Battery Life Replacing the Batteries ...

Страница 78: ...ed 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 wipes are not recommended as they may fade the monitor keypad Cleaning solutions not lis...

Страница 79: ...retheyareplacedinthebattery compartment Thedockingstationdoesnotchargethebatteries Chapter 11 Maintenance of the Precision Xceed Pro Monitor Replacing the Port Protector The port protector is designed to minimise the possibility of liquid entering the monitor through the strip port Should blood or control solution come into contact with the port protector the monitor should be cleaned and dried an...

Страница 80: ...12 Specifications Precision Xceed Pro Monitor Symbols Bar Code Types Important Safety Instructions ...

Страница 81: ...plied 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...

Страница 82: ...C Class 2 Laser Product Caution Use of controls adjustments or performance of procedures other than those specified herein may result in hazardous laser light exposure Class 2 laser scanners use a low power visible light diode As with any very bright light source such as the sun the user should avoid staring directly into the light beam Momentary exposure to a Class 2 laser is not known to be harm...

Страница 83: ...idely 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 ...

Страница 84: ...ded 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 Use of the accessory in the PATIENT VICINITY Evidence that the safety certificatio...

Страница 85: ...ol 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 ...

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