Abbott Precision XceedPro, Operator'S Manual

Page 1: ...recision PCx are trademarks of the Abbott Group of Companies Other trademarks are the property of their respective owners 2007 Abbott Operator s Manual Point of Care System ART14576 Rev A 11 07 Abbott Diabetes Care Inc 1360 South Loop Road Alameda CA 94502 USA for Blood Glucose Monitoring ...

Page 2: ...amples 3 1 Collecting Blood Samples 3 2 How to Obtain a 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 4 ControlTest 4 Operating Guidelines for Control Solution Testing 4 1 Control Test Procedure Glucose 4 2 5 Data Review 5 Dat...

Page 3: ...st Results 10 2 Error Messages 10 2 Technical Support Instructions 10 9 Returning an Instrument 10 9 Contacting Abbott for Service 10 10 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 PCx Plus Test Strips 12 1 Precision Xceed Pro Monitor 12 1 Symbols 12 2 Barcode Types 12 3 Importa...

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

Page 5: ...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 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 t...

Page 6: ...isnotfollowed 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 mg dL the equivalent value in the other unit of measure e g mmol L appears bel...

Page 7: ... to minimize liquid entering the monitor through the strip port Chapter 11 provides instructions for changing the port 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 changing the batteries Just below the battery compartment is a label with the unique serial number of the monitor On the side ...

Page 8: ...ormation about the test strip including the lot number calibration expiration date and expected control solution ranges One quick scan provides the monitor with all this information at the time of the test IMPORTANT Donotscanapacket sbarcodeanduseateststripfromanotherpacket Thismaycause incorrectresultstobegenerated Usetheteststripimmediatelyafteropeningitsfoilpacket Donotusetheteststripifthefoilp...

Page 9: ...o 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 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 Alternativ...

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

Page 11: ...ase 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 barcode scan this system will automatically proceed to the next screen The scanning beam shuts off in three seconds if nothing is detected DataEntryKeypad The data entry keypad allows you to enter identification nu...

Page 12: ...one time will return to the top of the menu tree Pressing the button a second time will switch to Test Mode Enter Press the Enter button after entering all needed information AudibleIndicator notvisible 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 ...

Page 13: ...ee 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 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 management ...

Page 14: ... 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 ...

Page 15: ... 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 barcode and then use a test strip from a different packet This may cause inaccurate results Apply a drop of blo...

Page 16: ...d How to Obtain an Arterial Blood Sample Use 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 target ...

Page 17: ...Test Mode The Menu button will toggle the monitor to Menu Mode 3 Press Scan to scan the Operator ID barcode 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 digits of the barcode 4 Press Scan to scan the Patient ID barc...

Page 18: ...ve 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 8 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 Press 2 to Confirm the information and continue tes...

Page 19: ...sert the test strip into the test strip port until it 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 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 beeps displa...

Page 20: ...hapter 5 for further information 5 8 mmol L IMPORTANT Ifthebloodglucoseresultappearstobeinconsistent lowerorhigherthanexpected theremay beaproblemwiththeteststrip Repeatthetestusinganewteststrip Resultsthatareincorrect mayhaveseriousmedicalconsequences Consulttheprescribingphysicianbeforemakingany changestodiabetesmedicationplansif ThebloodglucoseresultsarenotconsistentwiththephysicalsymptomsAND y...

Page 21: ...4 Control Test Operating Guidelines for Control Solution Testing Control Test Procedure Glucose ...

Page 22: ...0 days after opening or until the expiration date printed on the label whichever comes first Do not use control solutions after the expiration 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 control solution...

Page 23: ...3 Press Scan to scan the Operator ID barcode 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 digits of the barcode 4 Scan or manually enter the low control solution lot number via the keypad then press Enter You can sc...

Page 24: ... Prior to inserting the test strip ensure that the port protector is installed and that it is clean and dry Replace if necessary 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 area to fill completely Wipe the...

Page 25: ... If there is no prompt to enter a comment code skip down to step 11 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 11 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 ...

Page 26: ...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 ...

Page 27: ...formed 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...

Page 28: ...ess Scan to scan the Operator ID barcode 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 digits of the barcode 5 Choose the category of data to review What You See on the Display What You Do Comments Note Thefollowings...

Page 29: ...OperID The monitor shows the 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 monito...

Page 30: ...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 Date and Time of test Operator ID o prompt Note that test date and time alternates with Operator ID What You See on t...

Page 31: ...splay also shows Patient ID or Name p 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 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 step by step instructions to access the Data Review menu Note Thef...

Page 32: ...vailable for review The display also shows the acceptable range for this test and Comment Code Number in box Level low mid high Range if numeric Test Type Glucose 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 1000 control test results Pleas...

Page 33: ...mber of tests available for review The display shows the following 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 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 o...

Page 34: ...to the right of 1 Previous and 2 Next on the monitor indicates the number of tests available for review The display shows the following Comment Code Number in box Level 1 2 3 4 or 5 Test Type Glucose 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 t...

Page 35: ...6 Proficiency Test ...

Page 36: ...arts 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 barcode 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 digits of the bar...

Page 37: ...used and checks that the lot 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 Insert...

Page 38: ...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 11 If you are prompted to enter a comment code continue to step 12 otherwise skip forward to step 13 12 Scan or manually enter the comment code via the keypad ...

Page 39: ...7 Linearity Test ...

Page 40: ...aterials for use in confirming the calibration and linearity of glucose at the upper and lower limits of the reportable range and at three 3 points within the range Each CVC kit is designed for specific test strip types Please refer to the CVC package insert for compatible test strip types and detailed instructions for use Please use the following procedure to perform a Linearity Test This functio...

Page 41: ...e 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 7 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 The number in the parentheses ...

Page 42: ...been approved for use by your institution 9 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 10 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 inserti...

Page 43: ...ayed Once the assay begins all key presses are ignored until the assay is completed 13 Note the result If required scan or manually enter the comment code and press Enter The monitor may be enabled to scan or enter a 1 to 2 digit comment code If there is no prompt to enter a comment code skip down to step 14 The display includes the level and test numbers date and time Level indicates Level 1 5 Te...

Page 44: ...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 ...

Page 45: ...tient ID Determine whether the Patient ID is required optional or not used for patient tests Define the Patient ID prompt The number of digits are acceptable for the Patient ID can set a minimum and maximum number of digits between 1 and 30 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 determ...

Page 46: ...st 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 glucose strip lots that can be downloaded to the Precision Xceed Pro monitor is 18 Other Decide what additional information to download to a monitor through the data management system Lists of operators lists of strip lots or lists of ...

Page 47: ...roperly Next the software version and then the Test Mode menu screens will 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 What You See on the Display What You Do Comments Note Thissectionillustratessomerepresentativesettings Ifthemonitordoesnotdisplaythesescreens pleaserefertoChapter10 Troubleshoo...

Page 48: ...s Ifthemonitordoesnotdisplaythesescreens pleaserefertoChapter10 Troubleshooting 1 Press 1 for Test Setup 2 Press 1 for All Tests to continue to the All Tests Upload Interval screen 3 Press 1 Next to continue to the All Tests Operator ID screen 4 Press 1 Next to continue to the All Tests Operator ID Truncation screen 5 Press 1 Next to continue to the Operator ID Prompt screen 6 Press 1 Next to retu...

Page 49: ...somerepresentativesettings Ifthemonitordoesnotdisplaythesescreens pleaserefertoChapter10 Troubleshooting 1 Press 1 for Test Setup 2 Press 2 for Test Type to continue to the Test Type Glucose Units screen 3 Press 1 Next to continue to the Test Type Glucose Action Range screen 4 Press 1 Next to continue to the Test Type Glucose Critical Range screen 5 Press 1 Next to continue to the Test Setup menu ...

Page 50: ...Test Setup 2 Press 3 for Patient Test to continue to the Patient Test Patient ID screen 3 Press 1 Next to continue to the Patient Test Patient ID Truncation screen 4 Press 1 Next to continue to the Patient Test Comment Code If In Range screen 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 ...

Page 51: ...e to the Control Test Levels screen 3 Press 1 Next to continue to the Control Test Result screen 4 Press 1 Next to continue to the Control Test Comment Code If In Range screen 5 Press 1 Next to continue to the Control Test Comment Code If Out of Range screen 6 Press 1 Next to return to the Test Setup menu Note Thissectionillustratessomerepresentativesettings Ifthemonitordoesnotdisplaythesescreens ...

Page 52: ...refertoChapter10 Troubleshooting 1 Press 1 for Test Setup 2 Press 5 for Security to continue to the Security QC Interval screen 3 Press 1 Next to continue to the Security Operator ID Not Certified screen 4 Press 1 Next to continue to the Security Strip Lot Not on List screen 5 Press 1 Next to continue to the Security Patient Data Not Confirmed screen 6 Press 1 Next to continue to the Security Conf...

Page 53: ...menu screens will 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 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 6 Press 1 Next to continue to the System Status Time screen What You See on the Display What You Do Comme...

Page 54: ...ue 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 What You See on the Display What You Do Comments ...

Page 55: ...9 Data Upload Docking Station Connecting Cables to the Docking Station Mounting Instructions ...

Page 56: ...testing 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 will display Last upload incomplete Redock meter Turning Off The monitor will ...

Page 57: ...sfer 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 UseonlytheACadaptersuppliedbyADC Useofanyotheradaptermaycauseseriousdamagetothe dockingstationandtothePrecisionXceedProMonitorwhileitisinthedockingstation ConnectingCablestotheDockingStation The docking station has two ports located on t...

Page 58: ...wer and a working network connection Instructions for installing Abbott Data Repeater are available separately Mounting Instructions The docking station may be mounted vertically if desired This operation is similar to mounting a telephone on the wall 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 hol...

Page 59: ...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 ...

Page 60: ...ubleshooting 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 bottle s 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 concentration higher than expected ...

Page 61: ... test strip carton insert Check that the temperature conditions in the room where the tests are being performed are within the acceptable operating range Refer to the Precision PCx Plus Test Strip and CVC kit instructions for use Check CVC bottle for open bottle expiration date Use a new test strip for each test Use only Precision PCx Plus Test Strips Confirm that the CVC solution tested level 1 5...

Page 62: ...tor 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 The monitor may have a problem that prevents it from operating properly One of several four digit error codes may be displayed These codes provide Abbott additional information about the problem 1 Turn off the monitor Turn it ...

Page 63: ...t 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 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 system cannot confirm the Patient ID Press 1 to ReEnt...

Page 64: ...ed test strips 2 Repeat the scan with 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 barcode scanner or keypad 2 If the problem persists notify the system administrator The ID or lot number just scanned or entered is not...

Page 65: ...ists contact the system administrator for further information on operator certification The Operator ID entered has expired The menu item 2 Continue appear only if this option is set to Warn 1 Press 1 to ReEnter the ID using the barcode or keypad Or Press 2 to Continue testing using the Operator ID already entered 2 If the problem persists notify the system administrator The Operator ID is due to ...

Page 66: ...e 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 four digit error code and contact Abbott Technical Support 4327 The strip was removed during testing Repeat the test with a new test strip 4330 Blood glucose m...

Page 67: ...r 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 from the new lot There are no stored test ...

Page 68: ...F R 1910 1030 require that contaminated instruments equipment be decontaminated and packaged prior to shipping in a manner which minimizes the risk of exposing those persons involved in handling or transporting this equipment You are responsible for complying with these regulations At a minimum before returning an instrument you must perform the following steps 1 Remove all potentially contaminate...

Page 69: ... Care Vienna Austria Tel 0800 930 093 Belgium and Luxembourg Abbott Diabetes Care Louvain la Neuve Belgium Belgium Tel 0800 167 72 Luxembourg Tel 32 10 475 480 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 Gentofte Danmark Tel 45 3977 0190 Finland Abbott Oy Abbott Diabetes Care Espoo Finland ...

Page 70: ...215 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 AD...

Page 71: ...11 Maintenance Cleaning the Exterior Surface Replacing the Port Protector Battery Life Replacing the Batteries ...

Page 72: ...f while it is being cleaned Do not immerse or autoclave the monitor or flood it with any liquid 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 moni...

Page 73: ...w 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 Rechargeablebatteriesmustbeatroomtemperaturebeforetheyareplacedinthebattery compartment Thedockingstationdoesnotchargethebatteries Figure 1 Figure 2 11 2 Replacing the Port Protector The port protector is desi...

Page 74: ...12 Specifications Precision PCx Plus Test Strips Precision Xceed Pro Monitor Symbols Barcode Types Important Safety Instructions ...

Page 75: ...nction 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 18 Glucose Proficiency Test Results ...

Page 76: ...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 harmful This symbol indicates that this product affords electrical protection as Class II equipment as described in IEC 601 1 P...

Page 77: ...ly barcode 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 barcodes may be added for a total of 14 ...

Page 78: ...t Do not let 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 following is recommended by UL for ...

Page 79: ... 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 Gene...