Quidel Triage MeterPro User Manual Download Page 1

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User

Manual

Summary of Contents for Triage MeterPro

Page 1: ...Page 1 of 86 User Manual...

Page 2: ...lation 15 Unpack Meter 15 Power Meter On 15 Install Paper 16 Insert Supervisor Code Chip Module 17 To Change Meter Settings 17 Change Clock 19 Set User ID 20 Change Reference Ranges Thresholds for Tes...

Page 3: ...Purpose 49 Function 49 Last Record 49 Patient Results 50 Patient ID 50 Test Device Lot Number L N 51 User ID 52 From Date 52 Till Date 53 QC Results 54 QC Sample Lot Number L N 55 Device Lot Number L...

Page 4: ...ning 70 Check Battery Level 70 Battery Replacement 70 Total Quality Assurance 71 Introduction 71 Quality Assurance Functions 72 Internal Device Quality Assurance 72 Meter Quality Assurance 73 Software...

Page 5: ...ebsite quidel com If outside the U S contact local distributor or one of the Technical Support centers listed below You may also contact us at quidel com Region Phone E mail Address Europe and Middle...

Page 6: ...er ID Ranges Clock Meter Settings Test Settings QC Parameters Bypass x New User ID x Update User ID x Delete User ID x User ID List x QC Device Freq x QC Sample Freq x Number of Controls x Num Quant S...

Page 7: ...urer In vitro diagnostic medical device Consult instructions for use Authorized representative in the European Community Temperature limitation Humidity limitation Waste electrical and electronic equi...

Page 8: ...Control Calibration Verification Prescription use only Contents contains Expected values Biological risks Thaw Transfer pipette Mean Standard deviation CODE CHIP module Printer Paper Peel open here A...

Page 9: ...n use Do NOT write or place a label anywhere on the QC device as it may interfere with the device functionality Do not move the Quidel Triage MeterPro while a test is in progress Ensure all sample flu...

Page 10: ...Installation Guides the user through first time setup Section 4 Operation Guides the user through running tests recalling results and deleting results Section 5 Service and Maintenance Procedures Pap...

Page 11: ...d Quality Control QC functions that allow the person operating the meter to monitor quality control Unpacking The Quidel Triage MeterPro and the items that come with it are provided in a single box Qu...

Page 12: ...e and CODE CHIP module in the QC Device box AC DC Power Converter AA Batteries Rolls of Printer Paper additional rolls are supplied in each box of test devices Supervisor CODE CHIP module and CODE CHI...

Page 13: ...Page 13 of 86 Parts of the Quidel Triage MeterPro...

Page 14: ...result on paper Data Port Connection point for the optional Bar Code Scanner allowing the operator to scan patient or user identification data instead of manually entering numbers or letters on the k...

Page 15: ...When the test is completed the screen meter display will come to rest at the main menu Low Power Indicator 8 23AM 01 20 18 Time and date Menu items User Instructions RUN TEST RECALL RESULTS INSTALL NE...

Page 16: ...details about Installing Paper see the Care and Maintenance section b Tear or cut a clean straight edge to feed into the printer Do not cut paper at an angle as the printer must sense the edge of the...

Page 17: ...t The port is located on the left side of the meter towards the bottom front corner Note the orientation of the CODE CHIP module in the drawing below d Once the Supervisor CODE CHIP module is installe...

Page 18: ...ACTERS MISC ID Min 1 Max 20 1 20 1 20 AUX ID ENABLE DISABLE Disabled Disabled Enabled For reference record your settings in the space provided e Press the key to save changes to ID Settings Display Se...

Page 19: ...and press the key b Select CLOCK using the keys and press the key c Select the HOUR MINUTE area using the keys Type in the correct time using the number keys d Press the key to move to AM or PM e Sele...

Page 20: ...e keys Type in the new value for the HIGH or LOW cutoff as appropriate e Press the key to save changes For more details about Ranges Settings see page 33 Change Test Settings a Select SET PARAMETERS u...

Page 21: ...the keys d Press the key to save changes to the Bypass setting For more details about Bypass Settings see page 36 Prior to commencing patient testing remove the Supervisor CODE CHIP module from the me...

Page 22: ...e information is transferred into the Quidel Triage MeterPro s memory A CODE CHIP module typically needs to be installed only once and remains in the meter memory A CODE CHIP module does not need to r...

Page 23: ...or Disable Auxiliary ID Number of Characters in Misc Test ID DISPLAY SETTINGS Language Printer Mode Auto Power Off Display Contrast Printer Contrast COMMUNICATIONS Baud Rate Enable or Disable LIS Enab...

Page 24: ...see a list of programmable parameters METER SETTINGS CLOCK USER ID RANGES TEST SETTINGS QC PARAMETERS BYPASS SELECT WITH v OR AND PRESS ENTER OR PRESS EXIT The Set Parameters Menu 4 Use the keys to se...

Page 25: ...X column 8 Use the keys to choose the largest number of characters that will appear in the User ID The maximum number of characters possible is 16 9 Press the key to save changes Characters Pat ID Thi...

Page 26: ...aracters that will appear in the Auxiliary ID The maximum number of characters possible is 12 9 Press the key to save changes Aux ID Enable Disable This setting will turn on or turn off the Auxiliary...

Page 27: ...rgest number of characters that will appear in the MISC TEST ID The maximum number of characters possible is 20 9 Press the key to save changes Display Settings Language This setting will determine wh...

Page 28: ...Power Off 6 Use the keys to choose the desired timer setting for the meter to power itself off when not in use The choices are 1 2 HOUR 1 HOUR 2 HOURS 4 HOURS or NONE If NONE is selected the meter mus...

Page 29: ...n entered will allow data to be transmitted Baud Rate 1 1 1 1 From a list of programmable parameters choose METER SETTINGS using the keys 2 Press the key 3 Use the keys to select COMM SETTINGS 4 Press...

Page 30: ...S Enable 1 From a list of programmable parameters choose METER SETTINGS using the keys 2 Press the key 3 Use the keys to select COMM SETTINGS 4 Press the key 5 Use the keys to select LIS 6 Use the key...

Page 31: ...o the DATE 9 Using the keypad type in the 6 digit date according to the DATE FORMAT below it 10 Press to move to the DATE FORMAT 11 Use the keys to select MM DD YY DD MM YY or YY MM DD The previously...

Page 32: ...er ID you want to update To correct press to clear the entire ID or select the incorrect character by using the keys Then type in the correct ID 6 Press the key 7 The user ID is displayed with the exp...

Page 33: ...ing the month number the day number and the year number in the format you have chosen The numbers you type will appear from the right and move left as you continue to type To correct press to clear th...

Page 34: ...upervisor may wish to control which tests are available to be run at the time of patient testing The options are 1 ACTIVE ACTIV ON SCREEN The test is always run and cannot be deselected 2 INACTIVE INA...

Page 35: ...tive tests is 2 or 3 standard deviations QC Device Frequency The QC DEVICE FREQUENCY setting determines the maximum interval between QC Device tests that a user is allowed to run patient tests When th...

Page 36: ...ts 1 From the list of programmable parameters choose QC PARAMETERS using the keys 2 Press the key 3 Use the keys to select the information to the right of NUM QUANT STD DEVS 4 Using the keys select on...

Page 37: ...mple CODE CHIP module included in each box of controls Lot number begins with a C QC Device CODE CHIP module included in the black QC Device box comes with the Quidel Triage MeterPro and is labeled wi...

Page 38: ...rPro s memory 6 Press to return to acknowledge the message 7 Remove the CODE CHIP module from the CODE CHIP module Port 8 Place the CODE CHIP module back into its original container for storage INSTAL...

Page 39: ...software upgrade Supervisor Installation Procedure Otherwise No restriction SET PARAMETERS Access Control Supervisor Programmable Settings Supervisor DELETE RESULTS Patient Test Results Supervisor Unl...

Page 40: ...day of patient testing To run the QC Device test 1 Press the key to power the Quidel Triage MeterPro on 2 Select RUN TEST using the keys 3 Press the key 4 Type in your identification User ID To corre...

Page 41: ...e a printed copy of the results 13 Remove the QC Device from the Meter and place in the QC Device Box DO NOT DISCARD THE QC DEVICE IMPORTANT Important instructions for all tests a Gently insert the te...

Page 42: ...idel QC Sample To run the Quality Control sample 1 Press the key to power the Quidel Triage MeterPro on 2 Select RUN TEST using the keys 8 23AM 01 20 18 RUN TEST RECALL RESULTS INSTALL NEW CODE CHIP S...

Page 43: ...mpt to pull it out The device may be ejected by returning to the Main Menu and pressing EXIT 12 Repeat steps for each quality control sample IMPORTANT Important instructions for QC Sample Tests D If t...

Page 44: ...correct press to clear the entire ID or select the incorrect character by using the keys Then type in the correct ID 5 Press the key 6 Select PATIENT SAMPLE using the keys PATIENT SAMPLE QC DEVICE QC...

Page 45: ...st device has been pulled into the meter the meter will display a message similar to the following SELECT TESTS CARDIAC CKMB 2 MYO 3 TNI PRESS TO PAUSE OR 0 9 FOR TEST PRESS ENTER TO CONTINUE OR EXIT...

Page 46: ...he Main Menu and pressing EXIT IMPORTANT Important instructions for patient tests a If the test device s Internal Quality Control QC results are unacceptable the results for the affected analyte s wil...

Page 47: ...TEST SELECT WITH v OR AND PRESS ENTER PRESS EXIT TO EJECT DEVICE 7 Press the key 8 Type or scan the Misc Test identification Misc Test ID To correct press to clear the entire ID or select the incorre...

Page 48: ...has been inserted properly b Press the key to start the test c The Quidel Triage MeterPro pulls in the test device and scans it d When the test is complete the meter will beep and display the results...

Page 49: ...talled to view the full User ID Last Record Purpose Last Record is used to retrieve the test results for the last test run To retrieve the last record 1 Press the key to power the Quidel Triage MeterP...

Page 50: ...the selected panel will be displayed For individual patient results a Select Patient ID using the keys b Type or scan in the patient ID To correct press the key to clear the entire ID or select the i...

Page 51: ...to select the desired panel 10 Select DEVICE L N using the keys 11 To display all results for the selected panel press the key 12 To display results specific to one lot type in the lot number of the t...

Page 52: ...press the key 12 To display results specific to one User ID type in the User ID To correct press to clear the entire ID or select the incorrect character by using the keys Then type in the correct ID...

Page 53: ...e selected panel are displayed 15 Use the keys to view the entire record 16 Press the key to make a printed copy 17 Press the key to upload the selected results to LIS Till Date To retrieve results fr...

Page 54: ...s of these quality control QC tests can be retrieved from the Quidel Triage MeterPro s memory Quality Control QC test Results can be retrieved by QC Sample Results Panel Type QC Sample Lot Number L N...

Page 55: ...press to clear the entire number Then type in the correct number 12 Press the key 13 All results from test run on the requested QC Sample lot number for the selected panel are displayed 14 Use the key...

Page 56: ...ve QC results from tests run on the Quidel Triage MeterPro starting with the user you select 1 Press the key to power the Quidel Triage MeterPro on From the MAIN MENU select RECALL RESULTS using the k...

Page 57: ...he entire number Then type in the correct number 12 Press the key 13 All results from tests run from the date selected for the selected panel if QC Sample are displayed 14 Use the keys to view the ent...

Page 58: ...ackground If the QC for the lot has failed the word FAILED will appear in place of an expiration date If a CODE CHIP has been installed for a new lot but QC has yet to be established the words NOT RUN...

Page 59: ...Select MISC TEST ID using the keys b Type or scan in the Misc Test ID To correct press the key to clear the entire ID or select the incorrect character by using the keys Then type in the correct ID c...

Page 60: ...the keys 9 To display all results for the selected panel press the key 10 To display results specific to one lot type in the lot number of the test device To correct press the key to clear the entire...

Page 61: ...incorrect character by using the keys Then type in the correct ID 11 Press the key 12 All results from tests run by the requested user for the selected panel are displayed 13 Use the keys to view the...

Page 62: ...power the Quidel Triage MeterPro on 2 From the MAIN MENU select RECALL RESULTS using the keys 3 Press the key 4 Select MISC TEST RESULTS using the keys 5 Press the key 6 Select PANEL TYPE using the k...

Page 63: ...to clear the entire ID or select the incorrect character by using the keys Then type in the correct ID 9 Press the key to make a printed copy QC Sample Results To print all QC Sample Results 1 Press...

Page 64: ...SULTS using the keys 5 Press the key 6 Select MISC TEST RESULTS using the keys 7 Press the key to make a printed copy Upload Results to LIS When interfaced directly to an LIS selecting this feature wi...

Page 65: ...XXX MORE RECORDS PRESS ENTER The Memory Alert Screen IMPORTANT The Delete function permanently removes all patient data from the meter memory Before continuing you may wish to first print results or u...

Page 66: ...want to delete all patient results press the key Display Backlight The Quidel Triage MeterPro has the capability for the operator to backlight the display for providing improved clarity depending on a...

Page 67: ...o alpha character is displayed 6 M N O The first press of a button causes the first letter to be displayed The second press of the same button within three seconds causes the second letter to be displ...

Page 68: ...er at an angle as the printer must sense the edge of the paper along the feed path 5 Insert the new roll of paper into the paper compartment 6 Position the paper such that the paper will feed from und...

Page 69: ...Position the paper such that the paper will feed from under the roll as opposed to over the top of the roll see picture above 7 Insert the paper edge under the paper roller platen until it firmly seat...

Page 70: ...th front and back of the door Check Battery Level The Quidel Triage MeterPro checks the active power source after ejecting a device or printing To check the battery power navigate to the MAIN MENU dis...

Page 71: ...which analytical methods are traditionally controlled is through the use of liquid control specimens containing known amounts of analytes Over the last 15 years advances in technology have changed th...

Page 72: ...ontrol features provides more information about the validity of each assay than can be provided by the more traditional methods of reagent and assay procedure validation Quality Assurance Functions 1...

Page 73: ...izontal and vertical alignment of the zone measurement to verify laser alignment and device transport The QC Device also confirms laser stability A Bar Code is printed on the bottom of every test devi...

Page 74: ...r Total Quality Assurance features inherent in the Quidel Triage tests The Quidel Triage tests have been designed to maximize Total Quality Assurance in any testing environment The combination of the...

Page 75: ...the RECALL RESULTS menu 5 Supervisor Access To prevent misuse the Supervisor CODE CHIP module is required for access to the SET PARAMETERS and DELETE RESULTS functions of the software The Supervisor C...

Page 76: ...iode Memory Capacity 750 Patient Records 32 Reagent Lot CODE CHIP modules 200 QC Sample Results 200 QC Sample CODE CHIP modules 70 QC Device Results 4 QC Device CODE CHIP modules 250 Misc Test Results...

Page 77: ...ced Contact Quidel CODE CHIP module will not fit in meter a CODE CHIP module may have been inserted upside down a Re insert CODE CHIP module right side up b CODE CHIP module or Meter contacts could be...

Page 78: ...e eliminates the message the original CODE CHIP is at fault discard CODE CHIP module b Meter error b If the new CODE CHIP module does not work install a known working CODE CHIP module to verify proper...

Page 79: ...ed when the meter has been without power Press the ENTER key QC Device calibration alignment or laser failed Messages Calib Pass or Fail Laser Pass or Fail Align Pass or Fail a May be due to lint or d...

Page 80: ...nd Electronic Equipment WEEE Appendix D Glossary Analyte Chemical substance being measured Assay Test Calibration Comparison of result to a reference standard Character One part of a longer string of...

Page 81: ...Device Not all Quidel Triage test panels have the MMX feature Parameters Options functions Photodiode Detects the light emitted from the fluorescent dye in the test devices used in the Quidel Triage...

Page 82: ...DE CHIP module used to download new software onto the Quidel Triage MeterPro Supervisor CODE CHIP module The CODE CHIP module that allows a supervisor to set parameters and delete results Test device...

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Page 86: ...l Triage MeterPro MDSS GmBH Schiffgraben 41 30175 Hannover Germany Quidel Cardiovascular Inc 9975 Summers Ridge Drive San Diego CA 92121 USA quidel com ENSRC26611enA PN 26611en Rev A 2018 03 Revision...

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