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Xprecia Stride

 User Guide

Appendix C: Operational theory

Conducting the test: prerequisite phase

Stride ensures that the following prerequisites for 
conducting a test have been completed before proceeding:

 

» patient, operator, and calibration information has  

been read

 

» test strip has been inserted correctly

 

» test preparation has completed successfully

 

» the sample has been correctly applied

 

» checked for and displayed fault conditions 

that may interfere with the completion of the 
prerequisite process

Conducting the test: processing phase

Stride ensures that the following conditions for conducting 
the test are maintained during the active test sequence:

 

» maintenance of the test conditions

 

» data acquisition

 

» data processing

 

» checked for and displayed fault conditions that may 

interfere with the completion of the test-in-progress

Conducting the test: completion phase

Stride ensures that completion of a test is conducted in a 
controlled manner by: 

 

» displaying the computed test result differentiating 

between a patient test and QC test results

 

» testing the QC test result against the scanned high/low 

limits and a pass/fail indication provided depending on 
the test outcome

In addition, during this phase, Stride:

 

» monitors removal of the used test strip in a 

timely manner

 

» displays a post-test instrument cleaning reminder

 

» checks for and displays fault conditions that may 

invalidate the computed result

Performance characteristics

The 

Metrological Traceability 

is defined by the following: 

Each lot of Xprecia System PT/INR test strips is calibrated 
to a reference lot of human recombinant thromboplastin 
traceable to the World Health Organization International 
Reference Preparation.

Содержание XPRECIA STRIDE

Страница 1: ...ved All other trademarks are the property of their respective owners 11065784 Rev B 11065585 Made in MY Siemens Healthcare Diagnostics Inc 511 Benedict Avenue Tarrytown NY 10591 5097 USA Siemens Healthcare Diagnostics Ltd Sir William Siemens Sq Frimley Camberley UK GU16 8QD www siemens com poc シーメンスヘルスケア ダイアグノスティクス株式会社 東京都品川区大崎1 11 1 Siemens Healthcare Diagnostics 輸入 XPRECIA STRIDE USER GUIDE ...

Страница 2: ...XPRECIA STRIDE USER GUIDE ...

Страница 3: ...ifications equipment and maintenance procedures at any time without notice If the system is used in a manner differently than specified by Siemens Healthcare Diagnostics the protection provided by the equipment may be impaired See warning and hazard statements Made in MY Siemens Healthcare Diagnostics Inc 511 Benedict Avenue Tarrytown NY 10591 5097 USA Siemens Healthcare Diagnostics Ltd Sir Willia...

Страница 4: ...1 Start here ...

Страница 5: ...r required materials 6 Xprecia System PT INR Strips 6 Xprecia System PT Controls 8 Holding Stride 9 Setting up Stride the first time 10 Touch screen 16 Entering information 16 Examining the Home screen 17 Learning about the icons 18 Learning about the Stride barcode reader 21 Learning about the Stride keypad 22 Xprecia Data Management Software DMS 26 Learning more 28 2 Per forming a patient test 3...

Страница 6: ...2 1 Exploring Stride ...

Страница 7: ...ips and the Xprecia System PT Controls The analyzer uses fresh capillary fingerstick whole blood applied to an Xprecia System PT INR Strip It is intended for in vitro diagnostic use at the point of care Xprecia System PT INR Strips are for use with only the Xprecia Stride Coagulation Analyzer for PT INR determinations by professional healthcare providers This product is for in vitro diagnostic use...

Страница 8: ... Strips Each Xprecia System PT INR Strip contains the reagent Dade Innovin which is a preparation of purified recombinant human tissue factor combined with synthetic phospholipids calcium chloride and stabilizers Stride measures PT values in whole blood To begin testing the contact end of the test strip is inserted into the test strip port on the analyzer Then a blood sample is applied to the test...

Страница 9: ...h the control range information Using this information Stride indicates if the QC test results are acceptable or not CONSUMABLES 1 PT Control 1 2 PT Control 2 3 CaCl2 Diluent You must perform a QC test at the start of each shift and with every new lot new shipment or as required by local state and federal or national regulations For more information on Specifications see page 78 Holding Stride Be ...

Страница 10: ...ormation Installing the batteries INSTRUCTIONS 1 Press the latch on the battery compartment cover and pull it towards you to remove the cover 2 Insert the 3 batteries 3 Snap the battery compartment cover back into place Turning Stride on and off INSTRUCTIONS 1 Press Setting the date INSTRUCTIONS 1 Tap the month 2 Tap or to enter the current month 3 Tap the day 4 Tap or to enter the current day 5 T...

Страница 11: ...r 7 Tap Stride saves your changes X 10 00 am 10 05 2015 10 00 Setting the type of battery INSTRUCTIONS 1 Tap to choose rechargeable disposable 2 Tap Stride saves your changes 10 00 am 10 05 2015 Rechargeable Disposable Stride performs a minimum of 100 total patient or QC tests with disposable alkaline batteries under normal operating conditions Performance results for rechargeable batteries can va...

Страница 12: ...ur Stride settings to match your work environment For example you can require an operator password to use the device to perform a patient test For more information on Tutorials see page 59 Viewing the tutorials INSTRUCTIONS 1 On the Home screen tap 2 Tap 3 times 3 Tap 4 Tap to choose the tutorial you want Patient Test QC Test Orientation 5 Tap to cancel viewing a tutorial 10 00 am 10 05 2015 Langu...

Страница 13: ...ns You can enter your Operator ID OID or Patient ID PID using the keypad or the barcode reader Entering information You can enter information 2 ways Touch screen Barcode reader Examining the Home screen OVERVIEW 1 Battery Power 2 Time and Date 3 Patient Test 4 Settings 5 Current Screen 6 Recall Results 7 Quality Control Test 1 2 3 4 5 6 7 For more information on Learning about the icons see page 1...

Страница 14: ... Home screen Page Down Displays the next screen in a list Page Up Displays the previous screen in a list Recall Results screen Patient Test Results View patient test results Quality Control Test Results View QC test results Events Log View a listing of error and warning messages Settings screen Clock Change the time Date Change the date Analyzer Customize the volume brightness battery type default...

Страница 15: ...e Tap to enter uppercase letters Lowercase Tap to enter lowercase letters Accept Tap to accept your entry Learning about the Stride barcode reader When Stride requires information it prompts you to use the barcode reader The barcode reader enables you to easily scan important information about the test strips and test strip vials that you are currently using directly into Stride This information i...

Страница 16: ...ay to enter information If you make a mistake entering a number or letter tap to delete and enter the number or letter again For more information on Changing the administrator settings see page 56 2 1 4 7 8 0 5 3 9 6 Enter ID X Abc SCAN STAT Keypad input modes 2 1 4 7 8 0 5 3 9 6 Enter ID X Abc ABC DEF GHI TUV JKL WXYZ MNO PQRS Enter ID X abc def ghi tuv jkl wxyz mno pqrs Enter ID X Numeric keypad...

Страница 17: ...e Tap to enter lowercase letters Accept Tap to accept your entry Using the numeric keypad INSTRUCTIONS 1 Tap to display the keypad 2 To enter numbers tap the key that corresponds to the number you want 3 When you are done tap Using the alphabetic keypad INSTRUCTIONS 1 Tap to display the keypad 2 Tap to use the alphabetic keypad 3 Choose to do one of the following To enter lowercase letters Tap and...

Страница 18: ...ion Requirement A computer running DMS is necessary to configure and upload results from Stride To install DMS and start uploading data insert the DMS installation media into your computer and follow the installation instructions when prompted Then plug the USB cable from your computer into Stride and use DMS to export the test results Using DMS you can Set up and manage operators Configure and up...

Страница 19: ...ructions for use Read the IFU that shipped with your Xprecia System PT Controls kit The IFU contains important information about your current kit Keep the IFU for future reference Onboard user assistance Stride provides you with 2 types of onboard user assistance Tutorials and Help Viewing a tutorial INSTRUCTIONS 1 On the Home screen tap 2 Tap 3 Tap to choose Patient Test Walks you through perform...

Страница 20: ...30 2 Per forming a patient test ...

Страница 21: ...ferent test strip from another vial Each test strip is single use only never perform a second test using the same test strip Don t touch or move the test strip after you apply the drop of blood Don t move the test strip during the test Never add more blood to the test strip after the test has begun Refer to the Xprecia System PT INR Strips Instructions For Use for more information on test strips A...

Страница 22: ... blood sample Only use fresh whole blood from a capillary fingerstick source with test strips IMPORTANT Within 15 seconds of sticking the fingertip apply the drop of blood to the test strip target area Don t add more blood to the test strip once the test has begun Don t touch the test strip while the test is in progress Discard expired test strip vials Performing a patient test INSTRUCTIONS 1 To t...

Страница 23: ... complete Tip You can set Stride down to tend to the patient while the test is in progress 13 Press the Test Strip Eject button to discard the test strip according to your facility s biohazard control policies Requirement When ejecting a used test strip always point Stride down facing your biohazard container before you press the Test Strip Eject button 14 Discard the lancet according to your faci...

Страница 24: ...g the fingertip Viewing patient test results After you perform a patient test the results display INR 10 00 am PT 10 05 2015 1 2 9 58 am 10 05 2015 Outpatient 12K9 Operator 2980W The following information appears on the screen INR value time and date Patient ID PID and Operator ID OID if entered Understanding results Results display in the International Normalized Ratio INR Because desired ratios ...

Страница 25: ...e list of results tap a result to view the details INR value Time and date Patient ID PID if entered Operator ID OID if entered 4 Tap Test strip lot Test strip expiration date 5 Confirm the results as needed Outpatient 0629 INR INR INR INR 9 02am 10 05 2015 1 2 1 2 2 6 Outpatient 1228 8 57am 10 05 2015 Outpatient 5876 8 55am 10 05 2015 Outpatient 0826 8 03am 10 05 2015 X 10 00 am 10 05 2015 INR PT...

Страница 26: ...42 3 Per forming a LQC test ...

Страница 27: ...2 The assigned ranges are based on 2SD of the systems total variability You must perform QC tests at the start of each shift and with every new lot new shipment or as required by local state and federal or national regulations Refer to the Xprecia System PT Controls Instructions For Use for more information on quality controls Requirement Don t allow control solution to leak into the test strip po...

Страница 28: ...osition the transfer pipette so that the tip is almost touching the front edge of the test strip Gently squeeze the pipette base containing the control solution to apply some a minimum of 6 μL to the test strip target area Capillary action draws the control solution into the test strip target area Stride sounds an audible tone when the test strip target area contains enough control solution Be car...

Страница 29: ...e stores and lets you retrieve a minimum of 300 QC test results As new results are stored the oldest results are overwritten Recalling previous QC test results INSTRUCTIONS 1 On the Home screen tap 2 Tap 3 In the list of results tap a result to view the details INR value Time and date Control solution lot and range Operator ID OID if entered 4 Tap Test strip lot Test strip expiration date QC solut...

Страница 30: ...50 4 Ch anging the settings ...

Страница 31: ...RUCTIONS 1 Tap 2 Tap 3 Tap the 12 hour AM or PM or 24 hour 24h box 4 Tap or to set a time format 12 hour AM or PM 24 hour 5 To accept your changes and return to the previous screen tap Changing the date INSTRUCTIONS 1 Tap 2 Tap 3 Tap the month day or year The default selection is Day 4 Tap or to enter the month day and year 5 To accept your changes and return to the previous screen tap Changing th...

Страница 32: ...D list with the latest updates from DMS to Stride Changing the brightness INSTRUCTIONS 1 Tap 2 Tap 3 Tap 4 Tap or to find the screen brightness you prefer 5 To accept your changes and return to the previous screen tap Changing the battery type INSTRUCTIONS 1 Tap 2 Tap 3 Tap 4 Tap to choose rechargeable disposable 5 To accept your changes and return to the previous screen tap Restoring default sett...

Страница 33: ...ype for barcode reader for keypad 7 Tap Minimum 8 Tap or to enter the minimum number of characters for the PID 9 Tap Maximum 10 Tap or to enter the maximum number of characters for the PID 11 To accept your changes and return to the previous screen tap Adding an Operator ID OID Login INSTRUCTIONS 1 Tap 2 Tap 3 Tap 4 Tap Enable to require a password to use the device 5 Tap Validate to compare the p...

Страница 34: ... return to the previous screen tap Viewing the system information INSTRUCTIONS 1 Tap 2 Tap 2 times 3 Tap Tutorials To pause a tutorial screen press and hold your finger on the screen Remove your finger to continue the tutorial Viewing the tutorials INSTRUCTIONS 1 Tap 2 Tap 3 times 3 Tap 4 Tap to choose the tutorial you want Patient Test QC Test Orientation 5 Tap to cancel viewing a tutorial 10 00 ...

Страница 35: ...60 5 Performing troubleshooting and maintenance ...

Страница 36: ...nning out Replace with 3 new AA batteries 01 04 Invalid Login An incorrect Operator ID OID was entered Try reentering the Operator ID OID 01 05 Invalid OID An incorrect Operator ID OID was entered Try reentering the Operator ID OID 01 06 Invalid PID An incorrect Patient ID PID was entered Try reentering the Patient ID PID 01 07 LQC Expiration date exceeded Your lot of control solution has reached ...

Страница 37: ... by Stride 02 04 Early test strip ejection You ejected the test strip before Stride was finished processing the results Discard test strip and restart test with a new strip 02 05 Expired test strip The test strip is beyond the expiration date Verify the Stride date setting is correct and then redo the test using a test strip from a new vial 02 07 Test strip port protective cap removed You removed ...

Страница 38: ...e cap until it clicks into place Redo the test with a new strip 04 14 Heater control error Stride encountered an error with the internal heater Turn Stride off and on If the error persists you may need to replace the Stride analyzer 04 15 Test Strip Fill Error You attempted to double fill the sample area Redo the test with a new strip Miscellaneous messages CODE MESSAGE PROBABLE CAUSE POSSIBLE SOL...

Страница 39: ...e batteries in the device Be sure to replace all 3 batteries at the same time Changing your test strip port protective cap Replace the test strip port protective cap as needed Replacement of caps varies based on actual analyzer use The cap was designed for a minimum of 2 000 tests and Siemens recommends you visually inspect it for cracks or deteriorations and replace as needed Refer to the Analyze...

Страница 40: ...The lifespan of the analyzer will vary depending on actual usage For example when testing patients One 1 cycle One 1 wipe for cleaning One 1 wipe for disinfecting 10 cleaning cycles per day x 365 days x 2 years 7 300 cleaning cycles Cleaning Stride INSTRUCTIONS 1 Press to turn the power off 2 While wearing gloves remove 1 Siemens recommended germicidal wipe and thoroughly clean all blood and other...

Страница 41: ...ic materials are present that might cause damaging electrostatic discharges ESD Removing a Stride analyzer from service Contact your service and support representative if you need to take an analyzer out of service Always follow local procedures and guidelines for the disposal of hazardous waste Contacting service and support For Stride service and support information visit www siemens com poc 6 R...

Страница 42: ...s of CaCl2 Diluent Replacement parts NUMBER NAME DESCRIPTION REF 10714610 Xprecia Stride White Protective Caps 4 White strip port protective caps REF 10714611 Xprecia Stride Purple Protective Caps 4 Purple strip port protective caps REF 10714612 Xprecia Stride Green Protective Caps 4 Green strip port protective caps REF 10714613 Xprecia Stride Aquamarine Protective Caps 4 Aquamarine strip port pro...

Страница 43: ...76 Appe ndix A Specifications ...

Страница 44: ...rating No user accessible fuses Supported barcode specifications BARCODE SYMBOLOGIES 1D 2D Codabar Interleaved 2 of 5 Code 39 Code 128 Code 93 Code 49 Data Matrix ECC200 Aztec DMS Operating system requirements OPERATING SYSTEMS 32 BIT SYSTEM 64 BIT SYSTEM Microsoft Windows 7 Microsoft Windows XP Electromagnetic compatibility EMC Contact your local technical support provider Safety Certifications C...

Страница 45: ...80 Appendix B Safety ...

Страница 46: ...s Splashes or aerosol contact with skin and eyes Preventing contamination To prevent accidental contamination in a clinical laboratory strictly adhere to the following procedures Wear gloves while touching or cleaning parts of Stride that have contact with whole blood or Siemens control solutions No other body fluids should have contact with Stride Wash your hands before going from a contaminated ...

Страница 47: ...hogens in healthcare settings 1988 MMWR 37 377 382 387 388 2 Clinical and Laboratory Standards Institute formerly NCCLS Protection of Laboratory Workers from Occupationally Acquired Infections Approved Guideline Third Edition Wayne PA Clinical and Laboratory Standards Institute 2005 CLSI Document M29 A3 ISBN 1 56238 567 4 3 Federal Occupational Safety and Health Administration Bloodborne Pathogens...

Страница 48: ...86 A ppendix C Operational theory ...

Страница 49: ... Failure to pass any of these Power On Tests will prevent further operation of the analyzer Upon the start of a test Stride performs a self test to verify it s operational Stride electrically monitors for the presence of a test strip Upon test strip insertion Stride electrically connects to the test strip electrodes to acquire test data It also conducts test strip integrity checks to validate test...

Страница 50: ...displayed fault conditions that may interfere with the completion of the test in progress Conducting the test completion phase Stride ensures that completion of a test is conducted in a controlled manner by displaying the computed test result differentiating between a patient test and QC test results testing the QC test result against the scanned high low limits and a pass fail indication provided...

Страница 51: ...92 Appendix D Symbols ...

Страница 52: ...actitioner This symbol indicates that the product has a temperature limitation You need to store the product between 15 35 C This symbol indicates that you should keep the product dry Symbols This symbol indicates that the product is fragile and you need to handle it with care This symbol identifies that this electronic information product does not contain any toxic or hazardous substances or elem...

Страница 53: ...96 Appendix E Glossary ...

Страница 54: ...part of the LCD color display that allows you to tap buttons or options on the screen Stride software terms ABOUT Displays the software version number and serial number of Stride ADMINISTRATOR Specifies the administrator settings for a Patient ID PID an Operator ID OID and Login authentication AUDIO ALERT Sounds emitted by Stride to draw your attention to the system such as a beep AUTHENTICATION S...

Страница 55: ...log prothrombin time obtained with a standard reagent to the log prothrombin time obtained with the working reagent for both normals and patients who receive stable oral anticoagulant therapy the standard reagents used for this value assignment are reference preparations calibrated against the World Health Organization WHO standard reagent See the WHO Expert Committee on Biological Standardization...

Страница 56: ...SSAGES An informational message warning or error that requires corrective action to continue operating Stride TEST Analysis of a patient sample or a control solution TEST RESULT Measured reportable values displayed at the end of a test sequence TEST RESULTS Specifies the unit of measure for test results displayed for patient samples and QC samples TEST SEQUENCE A series of software UI screens that...

Страница 57: ...storing default settings 55 setiing the display brightness 54 setting Patient ID PID entry type 56 setting patient results in INR 55 setting QC results in INR 55 setting the battery type 55 setting the volume 54 tutorials 28 59 using the barcode reader 21 using the keypad 22 26 viewing error messages 62 70 viewing patient test results 38 viewing QC test results 48 49 Display brightness 54 Disposal...

Страница 58: ...Scan 20 Service and support 73 Setting battery type 55 brightness 54 language 58 patient test results units 55 QC test results units 55 time and date 52 53 volume 54 Settings screen icons 19 Setting up Stride 10 SMN 74 Software terms 99 Specifications dimensions 78 electrical 78 environmental 78 STAT test 56 Steps for adding an Operator ID OID 57 adding a Patient ID PID 56 changing the battery typ...

Страница 59: ...and date 52 53 Tone barcode reader 21 35 46 Troubleshooting 62 66 Turning on and off 10 Tutorials 28 59 defined 103 U Understanding results 39 User Guide 28 User interface symbols 17 20 24 V Validate Login option 57 Validate password 57 View error messages 62 65 66 miscellaneous messages 67 patient test results 38 QC test results 48 49 system messages 62 warning messages 63 64 Volume changing 54 W...

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