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Chapter 6, Quality Control

P/N 115191-IE, Manual revision: AB

Haemonetics

TEG

6s User Manual

Figure 6-2, Insert cartridge screen

Caution:

DO NOT remove the cartridge until prompted to do so, either

after normal completion of the test or as a result of choosing to stop the
test.

4. On the

Verify cartridge

screen, review the information to ensure that the

cartridge type displayed on the screen is correct, and then touch

next

Figure 6-3, Verify cartridge screen

5. On the

Test Information

screen, enter information for the test, if desired,

and then touch

next

Содержание TEG 6s

Страница 1: ...User manual HAEMONETICS S A Signy Centre Rue des Fl ch res 6 1274 Signy Centre Switzerland...

Страница 2: ...oper use and maintenance of certain Haemonetics Corporation products This manual should be used in conjunction with instruction and training supplied by qualified Haemonetics personnel Any failure to...

Страница 3: ...ocument to be valid Trademarks and patents Haemonetics TEG RapidTEG and Thrombelastograph are trademarks or registered trademarks of Haemonetics Corporation in the United States and or other countries...

Страница 4: ......

Страница 5: ...alyzer and packaging 13 Chapter 2 TEG Analyzer Description TEG Analyzer Description Overview 18 Exterior Front Components 19 LCD touch screen 19 Cartridge slot 19 Exterior Back Components 20 Carrying...

Страница 6: ...ing Test Results 41 Test results screen 41 Tracing screens 42 Configuring Settings 44 Configure date and time settings 44 Change the time zone 45 Configure LAN settings 47 Calibrate the touchscreen 49...

Страница 7: ...Alerts 82 Error messages 82 Warning messages 83 Critical alert messages 83 Error message table 84 Cleaning and Disinfecting the Analyzer 91 Materials needed 91 Clean the analyzer 91 Clean the filter 9...

Страница 8: ......

Страница 9: ...10 Purpose of the manual 10 What is the TEG 6s system 10 Intended use 10 Precautions 11 Customer Service 12 Clinical training 12 Repair service 12 Preventive maintenance 12 Product return guidelines...

Страница 10: ...ransitions from a liquid state to a gel like state during clotting the modulus of elasticity and resonant frequency increase The analyzer measures these variations in resonant frequency during clottin...

Страница 11: ...l before operating the TEG analyzer especially precautionary information and specifications The TEG analyzer is to be operated by qualified personnel only If this equipment is used in a manner inconsi...

Страница 12: ...r to Cleaning and Disinfecting the Analyzer on page 7 91 Preventive maintenance procedures should be conducted annually to ensure optimal mechanical functioning of the analyzer and are performed by a...

Страница 13: ...which could result in damage to equipment or impair the quality of the test results personal injury is unlikely Warning advises the operator against initiating an action or creating a situation which...

Страница 14: ...nous blood collection tube to be used for the test Color coded top conforms to ISO 6710 1995 CE mark General warning caution risk of danger Biological risks Consult instructions for use Applies to USA...

Страница 15: ...1 IE Manual revision AB UL listed to Canadian and US standards Fuse Direct Current Power ON OFF Indicates a push push switch where one position marked with a line is on and the other position marked w...

Страница 16: ......

Страница 17: ...Analyzer Description Overview 18 Exterior Front Components 19 LCD touch screen 19 Cartridge slot 19 Exterior Back Components 20 Carrying handle 20 Cooling fan 20 USB ports 20 Ethernet port 21 Fuse hol...

Страница 18: ...ve of an operator facing the TEG analyzer The TEG 6s system consists of an analyzer and disposable assay cartridges The analyzer contains a user friendly interface in the form of a color touch enabled...

Страница 19: ...splays instructions that guide the user through TEG analyzer operations All prompts directions selections and results are displayed on this screen Cartridge slot The cartridge slot at the front of the...

Страница 20: ...of the analyzer ensures that the internal temperature of the analyzer remains close to the ambient temperature This allows the widest possible range of sample temperatures to be selected without requi...

Страница 21: ...point for the power cord that is supplied by Haemonetics Do not replace the cord with a substitute If necessary contact the local Haemonetics representative for a replacement Always ensure that the po...

Страница 22: ...syringe Under instrument control the cartridge pulls the blood sample into up to four staging areas mixes the sample with reagents that have been dried in place and then transfers a small amount into...

Страница 23: ...and Precautions Storage and Handling 24 Storing and handling the analyzer 24 Storing and handling the cartridges 25 Transporting the analyzer 25 Warnings for the Operator 26 Electrical shock hazards 2...

Страница 24: ...e TEG analyzer Use the following guidelines to correctly place the TEG analyzer Place the TEG analyzer on a flat surface such as a table or lab bench Proper operation of the analyzer requires adequate...

Страница 25: ...ing on the type of reagent or control contained within them Refer to each product insert for storage and handling instructions Transporting the analyzer Before transporting the TEG analyzer from one l...

Страница 26: ...urce Electrical shorting and power supply damage may occur Bloodborne pathogens Users should adhere to Standard Precautions when handling or using this device All parts of the TEG analyzer system shou...

Страница 27: ...must be returned to Haemonetics for further inspection see Product return guidelines on page 12 for instructions Warning Haemonetics products must be properly cleaned and packaged prior to their retur...

Страница 28: ......

Страница 29: ...Set up the analyzer 34 Start the analyzer 35 Log into the analyzer 35 Update your password 36 Log out of the analyzer 37 Turn off the analyzer 37 Exploring the Touchscreen 38 Home screen 38 Icons 39 V...

Страница 30: ...rted using the TEG 6s analyzer and includes the following information TEG analyzer design principles how the analyzer works Understanding TEG parameters Setting up and logging in to the TEG analyzer E...

Страница 31: ...n monitors the harmonic motion of a pendant drop of blood in response to external vibration As the sample transitions from a liquid state to a gel like state during clotting the modulus of elasticity...

Страница 32: ...m Amplitude The ultimate strength of the clot LY30 Percent lysis 30 minutes after MA is finalized The LY30 measurement is based on the reduction of the tracing area that occurs between the time that M...

Страница 33: ...15191 IE Manual revision AB TEG Analyzer Tests Haemonetics provides various assay cartridges for use with the TEG analyzer Refer to the included product inserts for an explanation of the tests the rea...

Страница 34: ...a network connection contact TEG System Technical Support or refer to the TEG 6s SMS Site Administrator Guide 116420 IE 2 Remove the top foam supports and open the protective plastic bag 3 Grasp the a...

Страница 35: ...etion in the event of a power loss Start the analyzer To turn on the analyzer move the power switch at the rear of the analyzer from the O position to the I position After a brief startup sequence an...

Страница 36: ...e and Password fields highlighted in red Update your password When you are logged into the TEG analyzer you can update your password at any time from the Settings screen To update your password 1 From...

Страница 37: ...out in the lower left corner of the screen For more information about the Home screen see Exploring the Touchscreen on page 39 Turn off the analyzer It is safe to turn off the analyzer from the Login...

Страница 38: ...returns you to the previous step On every screen the device name and username of the person who logged in displays in the upper left corner and the system date and time displays in the upper right co...

Страница 39: ...s and warnings are displayed in popup windows For more information on error messages see Errors and Alerts on page 82 Figure 4 7 Location of icons in the interface The following table lists the icons...

Страница 40: ...level L1 and or L2 that is overdue Test run with QC overdue Error Warning Critical error The Patient test was completed all parameters finalized The QC test passed The Patient test timed out before a...

Страница 41: ...timer The timer begins when the test starts Once the assay is complete the timer stops and is replaced by the date and time that the test started C Test name Each test name one per channel is displaye...

Страница 42: ...st they display in the right column Tracing screens TEG tracings provide information at a glance about running or completed tests At any time you can access tracings by touching the tracings button on...

Страница 43: ...tracing screens a legend displays each test name and corresponding color for the tracing You can touch the test name in the legend to display the individual channel tracing for the test Figure 4 11 In...

Страница 44: ...lyzer uses the system date and time to prevent the use of an expired cartridge Note If you do not have Administrator privileges all functions accessible from the Settings screen are read only except t...

Страница 45: ...the down arrow for the Date Style and Time Style boxes and select the desired style for each An example of the currently selected styles is displayed to the right of the Time Style box 4 Touch apply...

Страница 46: ...13 Change Time Zone screen 2 Touch the down arrow for the Time Zone box to display a list of time zones Figure 4 14 List of time zones 3 Select the correct time zone from the list and touch apply A m...

Страница 47: ...ork LAN In most cases the DHCP Dynamic Host Configuration Protocol mode is preferred allowing the router to assign the IP address and subnet mask For more advanced network setup it is possible to sele...

Страница 48: ...analyzer off and then back on again If you want to Then Allow the router to assign the IP address and subnet mask a Next to Mode select DHCP b Touch apply Configure a static IP address and subnet mas...

Страница 49: ...calibrate 2 On the calibration screen carefully touch and briefly hold a stylus on the center of the target marked on the screen Repeat this process as the target moves around the screen Figure 4 17...

Страница 50: ...50 Chapter 4 Getting Started P N 115191 IE Manual revision AB Haemonetics TEG 6s User Manual Figure 4 18 About screen 3 Touch back to return to the Settings screen...

Страница 51: ...Chapter 4 Getting Started 51 Haemonetics TEG 6s User Manual P N 115191 IE Manual revision AB...

Страница 52: ...view 54 Disposable assay cartridges 54 Blood samples 54 Running a Patient Test 55 Quick guide for running a patient test 55 Detailed guide for running a patient test 55 Stopping a Test 63 Viewing Stor...

Страница 53: ...cartridge for the assay you wish to run Tear the pouch at the provided notch to remove the cartridge and then place the cartridge in the analyzer when prompted Inserting the cartridge triggers a barc...

Страница 54: ...y that the cartridge type is correct and then touch next 5 On the Test Information screen enter information for the test and then touch next 6 Add blood to the cartridge sample port filling up to or a...

Страница 55: ...en 3 Optional If the patient is not listed add a new patient ID by doing the following a Touch b On the Add Patient screen enter a new patient ID maximum of 20 characters for the analyzer and then tou...

Страница 56: ...rmation is correct Touch reject if the patient information is incorrect In the confirmation message that appears touch yes if you wish to continue the test with rejected patient data or touch no to re...

Страница 57: ...pted to do so either after normal completion of the test or as a result of choosing to stop the test 8 On the Preparing Test Verify cartridge screen review the information to ensure that the cartridge...

Страница 58: ...then touch next Figure 5 7 Test Information screen The Preparing Test Load sample screen displays Figure 5 8 Preparing Test Load sample screen 10 Using a pipette or syringe load blood into the cartri...

Страница 59: ...Figure 5 9 shows an in progress assay after 16 minutes has elapsed Figure 5 9 Test results in progress 12 Touch tracings to view a graphic representation of the results To cycle through superimposed o...

Страница 60: ...st timer is replaced by the date and time that the test started The stop button is replaced by a done button The print button is enabled Figure 5 11 Test results complete 14 When the analyzer displays...

Страница 61: ...62 Chapter 5 Operating the TEG Analyzer P N 115191 IE Manual revision AB Haemonetics TEG 6s User Manual Figure 5 12 Finishing Test Remove cartridge screen...

Страница 62: ...p a test early for example if LY30 is not required by the clinician you can manually stop the test after MA has finalized Note You can also cancel a test by touching stop from the Preparing Test scree...

Страница 63: ...Figure 5 14 Stopped test screen for a patient test 2 Do one of the following Touch discard to delete the test and return to the main menu Touch save to store the partial test Note If partial results...

Страница 64: ...test view the results 4 If desired touch tracings to view a graphic representation of the results To return to the results page touch results 5 Touch back to return to the Stored Tests screen 6 Touch...

Страница 65: ...ored Tests screen Note The status of each test is shown on the right side of the screen A green check mark indicates that the test completed all parameters were finalized and an orange triangle indica...

Страница 66: ...g until the desired view is displayed For more information see Tracing screens on page 43 Touch results to return to the results screen 5 If desired touch print to print the test results for the patie...

Страница 67: ......

Страница 68: ...on AB Chapter 6 Quality Control Performing Quality Control Tests 70 Quick guide for running a QC test 70 Detailed guide for running a QC test 71 Viewing Stored QC Data 77 Quick guide for viewing store...

Страница 69: ...igured to require successful quality control testing at a particular time interval This interval is determined by hospital policy and configured by the System Administrator When the end of the specifi...

Страница 70: ...screens 8 When prompted to remove the cartridge dispose of it properly 9 Touch done to return to the main menu Detailed guide for running a QC test 1 From the Home screen touch new qc Figure 6 1 Home...

Страница 71: ...ted to do so either after normal completion of the test or as a result of choosing to stop the test 4 On the Verify cartridge screen review the information to ensure that the cartridge type displayed...

Страница 72: ...creen displays Figure 6 5 Preparing Test Load sample screen 6 Prepare the QC material according to the instructions in the package insert Note Each QC vial once reconstituted contains 1ml of QC materi...

Страница 73: ...e 6 6 shows an in progress assay after 14 minutes has elapsed Figure 6 6 QC test results in progress 9 Touch tracings to view a graphic representation of the results To cycle through superimposed offs...

Страница 74: ...that QC passed for the channel and a red indicates that QC failed for the channel If all four channels passed the QC overdue icon at the top of the screen no longer shows the QC level that passed The...

Страница 75: ...76 Chapter 6 Quality Control P N 115191 IE Manual revision AB Haemonetics TEG 6s User Manual Figure 6 9 Finishing Test Remove cartridge screen...

Страница 76: ...lected test view the results 4 If desired touch tracings to view a graphic representation of the results To return to the results page touch results 5 Touch home to return to the Home screen Detailed...

Страница 77: ...en view the test results Figure 6 12 Viewing QC test results 4 If desired view the tracings for the test by touching tracings To cycle through superimposed offset and single tracing views touch next t...

Страница 78: ...91 IE Manual revision AB Note If no printer is attached to the analyzer a Failed to print results error message displays For more information see Printer specification on page 89 6 Touch back to retur...

Страница 79: ......

Страница 80: ...n AB Chapter 7 Troubleshooting and Maintenance Errors and Alerts 82 Error messages 82 Warning messages 83 Critical alert messages 83 Error message table 84 Cleaning and Disinfecting the Analyzer 91 Ma...

Страница 81: ...ared to describe the problem and report the error code number that accompanied the error message Error messages When an error occurs the TEG analyzer displays a description of the error and instructio...

Страница 82: ...indicative of a larger problem it is advisable to contact the local Haemonetics representative to report the problem Note If a warning occurs during data collection no data is lost Figure 7 2 shows a...

Страница 83: ...ction 1000 The instrument has unexpectedly been reset The analyzer was unexpectedly reset while idle Turn the power off and then back on to reboot the analyzer If the problem persists contact the loca...

Страница 84: ...in instrument There was a vacuum leak in the analyzer Contact the local Haemonetics representative 1033 Vacuum leak in cartridge There was a vacuum leak in the cartridge Remove the cartridge and reru...

Страница 85: ...mple was delivered to the cartridge rings may indicate issues with optics pressure or cartridge Remove the cartridge and rerun the test using a new cartridge If the problem persists contact the local...

Страница 86: ...action requires administrator access if no administrator is available or if the problem persists contact the local Haemonetics representative 3027 Power On Self Test Fault Diskspace is critically low...

Страница 87: ...nd rerun the test using a new cartridge If the problem persists contact the local Haemonetics representative 3054 Error reading barcode Barcode cannot be read by analyzer Remove the cartridge and reru...

Страница 88: ...r for assistance The Patient test cartridge may be expired An update to the Cartridge Store Table is required to determine the expiration date Contact the System Administrator for assistance in downlo...

Страница 89: ...ds have not been backed up or printed The analyzer in stand alone mode is approaching the maximum storage capacity 300 for patient tests and 90 of the tests have not been printed or backed up Print th...

Страница 90: ...tacles Caution Turn off the analyzer and unplug it from the wall before cleaning Do not steam sterilize or autoclave the analyzer or any cartridge Do not immerse the analyzer or cartridge in any solut...

Страница 91: ...ng on frequency and conditions of use To clean the filter 1 Grasp the edges of the filter cover and pull to remove it 2 Remove the filter from the cover 3 Rinse the filter under warm running water unt...

Страница 92: ...sion AB Chapter 8 Specifications and Performance Characteristics Specifications 88 Physical specifications 88 Environmental specifications 88 Electrical specifications 88 Printer specification 89 Perf...

Страница 93: ...ifications The electrical specifications for operating the TEG analyzer are as follows Characteristic Value Dimensions Width 175mm 6 9 in Length 257mm 10 1 in Height 270mm 10 6 in Weight 4 2 kg 9 4 lb...

Страница 94: ...nual revision AB Printer specification Haemonetics recommends the Epson TM T2011 USB thermal receipt printer 118034 00 for use with the TEG analyzer Supply Frequency 50 60 Hz Replaceable Fuse 5 Amp Ma...

Страница 95: ...Any changes or modifications not expressly approved by Haemonetics could void the user s authority to operate this equipment Warranty Haemonetics warrants its manufactured products excluding disposabl...

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