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Page 11 

 

4.  Performance Characteristics

 

Expected Values

: Results are reported in INR units equivalent to 

the  plasma  reference  method.  For  PT  testing,  variations  in  the 
source  of  thromboplastin  may  cause  some  differences  in  results 
between  methods.  It  is  recommended  that  the  same  method  be 
used to monitor the anticoagulation therapy over time. 

Measuring Range

: INR 0.8 to 8.0 

Normal  Range

:  The  following  example  represents  a  common 

normal range for the Coag-Sense PT/INR system. 

INR: 0.7 to 1.2 
PT: 8.0 to 15.0 

 

 

 

 

 

 

 

 

 

 

 

 

Содержание INR

Страница 1: ......

Страница 2: ...the information contained in this manual is correct at the time of printing However CoaguSense reserves the right to make any changes necessary without notice as part of ongoing product development If you have any questions or concerns with the Coag Sense Prothrombin Time PT INR Monitoring System please contact CoaguSense Technical Support at CoaguSense Inc 48377 Fremont Blvd STE 113 Fremont CA 94...

Страница 3: ...ions for Use 18 7 Meter Setup 18 8 Performing a Control Test 26 9 Collecting a Fingerstick Sample 31 10 Performing a PT Test 35 11 Reviewing the Memory 40 12 Printing 42 13 Network Connectivity and Security 44 14 Bluetooth App Security 44 15 Meter Software Update 44 16 Battery 45 17 Cleaning and Disinfecting the Meter 46 18 Troubleshooting 48 19 Warranty 57 20 Reordering Information 58 21 Index 59...

Страница 4: ......

Страница 5: ...ticoagulation therapy Patients should be stabilized on warfarin type coumarin anticoagulation therapy prior to self testing The device is not intended to be used for screening purposes Importance of PT INR Monitoring Blood Clotting Time The rate at which blood clots is measured in units is called International Normalized Ratio INR It is very important for patients to stay within their individual t...

Страница 6: ...ser Manual is to help you understand your Coag Sense PT INR system its parts and its intended function It provides you with the information you need to perform a PT test with the Coag Sense PT INR system The Coag Sense system should only be used with a doctor s prescription Do not adjust your medication without talking with your doctor or health care professional You must complete proper training ...

Страница 7: ...me PT INR System is used for quantitative measurement of INR International Normalized Ratio based on a Prothrombin Time PT response to monitor the effect of therapy with vitamin K antagonists like Coumadin warfarin The system uses fresh capillary whole blood ...

Страница 8: ...e Ethernet cable for a wired connection this port is provided with a port cover Reset button enclosed within the ethernet port cover is used to reset the meter in case of software or power cycle issues The meter performs a self check when it is first powered ON and every time a test strip is inserted If there are any problems detected during self check an error message is displayed on the touchscr...

Страница 9: ...functions battery level and optical and mechanical functions are within specification There are 2 low control strips 2 high control strips and a control activation solution shipped with each test strip kit Each control strip contains plasma of known INR Real plasma allows for a fully functional liquid quality control test of both the a reagent s ability to generate a clot and b the analyzer s abil...

Страница 10: ...apter also serves as a charger It charges the in built Lithium Polymer Battery Note The Battery is not User replaceable To save power the meter automatically powers itself OFF if left unattended for a set time user configurable When the meter powers itself OFF all results obtained up to that point remain in the memory Coag Sense PT INR Patient Self Test System Catalog 03P70 01 is supplied with the...

Страница 11: ...em Description Qty Patient Test Strips 50 Low Control Strips 2 High Control Strips 2 Control Strip Activation Solution 1 Lot Info label w NFC Tag Bottom Right Corner of Box 1 Sample Transfer Tubes w plungers 54 Package Insert 1 Following are standard medical supplies that are required with each use and may be supplied by your testing service provider Single Use 21g Auto Safety Lancets Note These m...

Страница 12: ... the meter press and hold Power Button To Enter Exit Sleep Mode press the button twice quickly Cancel or return to previous screen Go to the home screen View additional menu Common Keypad input a and b is the input completion button Returns to previous screen when selected c Change language button Enables the user to select keyboard language The Status bar a Date and Time b Sound ON OFF status c A...

Страница 13: ...cts to the logout pop up screen Home Screen a Test Icon Directs User to Test Strip information screen and subsequently to testing screen b Control Icon Allows User to select between High and low control tests Then directs User to Test Strip information screen and subsequently to control screen c Results Allows User to view Patient and Control test results Refer to Reviewing the memory section for ...

Страница 14: ...thium Battery Rechargeable Lithium Polymer Battery 3 7V 2350mAh Battery Capacity Fully charged 6 hours of charging can run 200 tests Power Input 120V AC Adapter Use with Coag Sense Adapter Only Power Output 5 0V 2 0A Blood Sample Size 10 12 µL Communication Port Micro and Standard USB Size in mm Height x Width x Depth 152 x 100 x 29 5 Weight in g 315g Equipment Classification Class II with externa...

Страница 15: ...ations in the source of thromboplastin may cause some differences in results between methods It is recommended that the same method be used to monitor the anticoagulation therapy over time Measuring Range INR 0 8 to 8 0 Normal Range The following example represents a common normal range for the Coag Sense PT INR system INR 0 7 to 1 2 PT 8 0 to 15 0 ...

Страница 16: ...he system should also not be used to monitor patients on direct oral anticoagulants DOACs including Factor Xa and Direct Thrombin inhibitors Test Site and Blood Sample The Coag Sense PT INR system is for in vitro diagnostic use only The Coag Sense meter will not produce a result if the test strip is past its expiration date The quality of the blood sample can affect PT test results A blood sample ...

Страница 17: ... matter which may cause unreliable results If Isopropyl Alcohol IPA wipes are used wipe the fingerstick site with a gauze pad and make sure the site is completely dry If any alcohol remains or is re introduced on the finger it may cause unreliable results The quality of fingerstick and the sample delivery technique are important to the test results If there is a question about the sample or sample...

Страница 18: ...test Unreliable results may occur Do not pull the strip out while the wheel is spinning STOP the test meter will display Test Cancelled Remove Strip The strip should be removed at this time only Store and use the Coag Sense PT INR system following the instructions in this manual This equipment is tested to meet the limits for medical devices which are designed to provide a reasonable protection ag...

Страница 19: ...dify this meter The Coag Sense meter does not require any periodic maintenance and there are no user serviceable parts inside If you have problems please contact Technical Support The Coag Sense Prothrombin Time PT INR Monitoring System needs special precautions regarding EMC and needs to be put into service according to the EMC information provided in this manual Portable and mobile RF communicat...

Страница 20: ... are potentially infectious Discard used materials in a puncture resistant biohazard waste container using universal precautions PT Test Strips Control Strips and Control Strip Activating Solution are perishable goods with a limited shelf life Do not use any of these items if the expiration date has passed Refer to the package insert that is supplied with each box of test strips for more informati...

Страница 21: ...logical risks The strips and fingerstick materials should be disposed of in appropriate biohazard waste containers Electronic device Dispose of unit properly Use by Expiration Date Lot number For In vitro diagnostic use Storage temperature range Manufacturer Single Use Only Do Not Reuse Catalog Number The system fulfills the Canadian and U S safety requirements NEMKO listed Consult Instructions fo...

Страница 22: ...eed until the meter is at room temperature Relative humidity should be between 10 and 90 without condensation for testing Avoid dropping the meter or treating it roughly Use the meter only on a level stable surface Do not move or touch the meter during testing Power ON OFF The Coag Sense PT INR Patient Self Test System can be operated with the power adapter provided The power adapter also serves a...

Страница 23: ...ne is Pacific Standard time UTC 8 00 User may modify User settings as appropriate Refer to User Settings section in this manual for the list of settings and their function These User settings help the User to configure their PT INR meter No Action Image guided instruction Device Information Setting 1 Device Information Screen ...

Страница 24: ... version available it can be found in this screen only if meter is connected to the Internet Refer to Section 15 b Clicking the new version will download the version c User may choose to Reboot the meter after the download or push the reboot to a later time Device Settings 1 Device Settings Screen ...

Страница 25: ...truction 2 Theme User chooses from Mono Blue Color 3 Language Setup Note The default language is set to English 4 Date Format Setup 5 Time Format Setup 6 Date and Time Setup Note The time automatically adjusts for daylight savings time ...

Страница 26: ...rightness User chooses from range of 1 7 9 Sound Setting User chooses to Turn sound ON or OFF 10 Target Range Setup 11 Alarm User can set alarm as a reminder function with Time and set to repeat on selected days of the week User may edit delete an alarm at any time ...

Страница 27: ... This screen displays icons that a Scan for Wireless networks nearby b Wireless ON OFF icon Clicking the Connect icon will require User to input passphrase to connect to the network 3 Upon clicking the Setup icon the touchscreen displays the Wireless Information screen the User may a select a connection method and b input the fields containing network information Click Confirm to proceed and input...

Страница 28: ...n 5 Bluetooth Setting This screen displays icons that a Scan for Bluetooth enabled devices nearby b Bluetooth ON OFF icon c Bluetooth broadcast icon This screen displays the list of scanned Bluetooth enabled devices 6 Broadcast Bluetooth will pair the Coag Sense PT INR meter to external device Note Set the external device ready to connect to the Coag Sense meter 7 The touchscreen displays a messag...

Страница 29: ...ge guided instruction 8 External Connection a Screen lists server IP address for socket communication b Open Close port for serial communication with external program c Connects PT INR meter to PC program using Bypass Mode ...

Страница 30: ...e controls may be run in any order The meter will display and store the results in PT seconds only The meter does not use or require results from the control strips prior to running a patient test strip Note If an error message appears consult the Troubleshooting section of this manual WARNING DO NOT move or touch the meter while it is running a test Unreliable results may occur Follow these steps...

Страница 31: ...box or bag from your service provider against the NFC Tag scanner centric rings next to test strip insertion area on the meter the Lot six digit numeric identifier and Barcode eight digit numeric identifier will auto populate If the box bag with NFC tag is not available you may manually enter the Lot and Barcode using the keypad on the touchscreen into the respective fields Press the forward butto...

Страница 32: ... display shows a countdown in seconds Note Do not apply the control activation solution until the warm up is complete and the meter display shows Apply Control Solution 7 Insert the black plastic plunger into the end of the glass capillary tube with the red stripe Use care to avoid hitting white plug Note Your home testing service provider may have supplied you with transfer tubes that have the pl...

Страница 33: ...ounter top to steady Insert transfer tube tip into sample application well of test strip touching tip down at flashing green light in front of wheel Depress black plunger completely to dispense the activation solution 10 When the control activation solution is properly applied and detected the flashing green light will turn off and the meter will display Testing Please Wait Note If this screen is ...

Страница 34: ...Steps 3 12 using the High control strip 13 Once the controls have been successfully tested remember to remove and discard the control strips You can now proceed to testing blood samples If you are not going to test turn off the meter by pressing and holding the POWER button The opened control activation solution may be used until the expiration date Note If control test fails repeat the test with ...

Страница 35: ... that prevent getting good access to the blood One of the middle or index fingers on either hand is recommended Gently squeeze or massage the finger to be lanced near the tip Good circulation can be seen if the patient s fingertip changes to a pinkish shade Use a 21g 1 8 mm depth single use auto disabling lancet Smaller gauge shallow depth lancets i e diabetes 23g lancets should not be used Refer ...

Страница 36: ...d test strips transfer tubes and lancets are potentially infectious Dispose of strips and collection devices using universal precautions No Action Image guided instruction 1 Wash your hands with soap and warm water Dry completely If cleaning with an alcohol wipe the finger must be wiped dry with sterile gauze air drying is insufficient to remove residual alcohol in time 2 Dry the fingertip with ga...

Страница 37: ...inger until meter displays APPLY SAMPLE A minimum of 10µl of collected blood sample is required Note The blood should flow freely If it doesn t gently squeeze the finger to get it started Lowering the patient s hand and arm so that the fingertip is below the heart helps the blood drop form 5 When ready to collect the drop of blood hold the Sample Transfer Tube horizontal Touch tip to bead of blood...

Страница 38: ...luid that cause unreliable results 6 Once you have collected the blood sample IMMEDIATELY put it into the sample well on the test strip See Performing a PT Test section of this manual WARNING If there is a bubble or an air pocket present in the blood sample in the transfer tube start the test over with a fresh fingerstick on a different finger ...

Страница 39: ...g the POWER button on the right side of the meter After startup and self check the display will show the Home Screen 2 To perform a Patient test press the Test icon on display screen 3 Patient Strip lot confirmation screen displays the Lot information of the strip that was last recorded Proceed with testing if the test strip is from the same lot Otherwise touch the NFC tag against the NFC tag scan...

Страница 40: ...ip by tearing the notched end 5 Holding the round end gently push the strip completely into the meter The strip fits snuggly when pushed all the way toward the back wall of the strip insertion area 6 The meter warms the strip for 25 seconds to operating temperature The display shows a countdown in seconds Note Do not apply test sample until the warm up is complete and the meter display shows Apply...

Страница 41: ...e at a 45º angle into the sample well on the test strip in front of the wheel where you see the flashing green light Gently touch the tip down onto the sample well Depress the plunger completely to dispense blood sample Note Depress black plunger completely to dispense the blood 8 When the sample is detected the meter displays a Testing Please Wait message Note If this screen is not displayed with...

Страница 42: ... displays messaging for example CLOT TIME TOO SHORT or NO CLOT DETECTED 10 Remove the test strip and properly dispose Note Repeat the test if the results seem unusually low or high If the results still seem unusual after a second test contact Technical Support 11 You may print the results if you purchased the optional portable printer Refer to the Printing section in this manual Note The meter sto...

Страница 43: ...Changes in diet lifestyle or taking nutritional supplements such as ginkgo biloba can affect the action of oral blood thinners and the INR value Liver diseases congestive heart failure thyroid dysfunction Lupus antiphospholipid antibody syndrome APS and other diseases or conditions can affect the action of oral blood thinners and the INR value Notify your doctor if you have any of these conditions...

Страница 44: ...ngth of time Test results stored in the Memory cannot be manually erased by the user Follow the steps below to review results in memory No Action Image guided instruction 1 1 Turn the meter ON by press and holding the POWER button on the right side of the meter User is directed to the Home screen Press the Results icon on display screen 2 2The Results screen lists Patient test results and Control ...

Страница 45: ...l Note The target range lines are set in Settings Device Settings Target range The unit of the x axis value of the chart depends on the period selected The User may choose to view up to one month 5 5When an individual result is viewed a memo can be added or changed and the result can be printed to an optional portable printer ...

Страница 46: ...rinting results Steps may vary slightly depending upon the model of printer purchased No Action Image guided instruction 1 Plug the USB cable from the portable printer into the USB port of the meter 2 2 From the individual result display click the printer icon in the lower right hand corner of the screen to print the result 3 You may choose from three different printer connection modes Network and...

Страница 47: ...it automatically turns OFF after a few minutes Note that the meter can only print to specific printers qualified and supplied by CoaguSense The meter cannot print directly to your home computer printer For assistance with the printing function call Technical Support at 1 866 903 0890 ...

Страница 48: ...free of malicious code including intrusion detection 14 Bluetooth App Security For security reasons it is recommended that you only connect your Coag Sense meter to Bluetooth apps that have been provided to you by your home testing service provider or CoaguSense 15 Meter Software Update When connected to the Internet the Coag Sense meter will check for the availability of meter software updates wh...

Страница 49: ...ar on the touchscreen of the meter displays a red indicator in the Battery status icon The touchscreen displays a Low Battery warning The battery begins charging as soon as the power adapter is connected to the power supply WARNING Lithium Polymer batteries may explode or combust if mishandled Do not subject the meter to prolonged exposure to sunlight or place the meter on or in heating appliances...

Страница 50: ...on port or battery compartment Dispose of the used towelette The meter should be allowed to air dry before use The test strip is designed to contain the patient sample preventing it from entering the meter Do not clean disinfect inside the meter where the test strip is inserted Cleaning this area should be avoided Please call Technical Support at 1 866 903 0890 if this area requires cleaning disin...

Страница 51: ...ck Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens Initial Communication 2010 http wayback archive it org 7993 20170111013014 http www fda gov MedicalDevices S afety AlertsandNotices ucm224025 htm CDC Clinical Reminder Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens 2010 https www cdc gov injectionsafety fingersti...

Страница 52: ...continued The charging of the battery can generate enough heat to raise the internal temperature of the meter outside the operating range Move the meter to a place that is within the operating temperature range of the meter 65ºF to 90ºF 18ºC to 32ºC and allow meter time to adjust to correct temperature Repeat testing Allow meter to complete charging prior to initiating testing REMOVE STRIP Meter t...

Страница 53: ...al Support LIQUID PROBLEM There may be a problem with the strip or with the optical system of the meter Take the strip out and reinsert holding the back of the instrument steady with one hand while inserting the strip completely with the other hand Insert the strip using a quick smooth motion Try again with another strip If the message persists contact Technical Support MOTOR PROBLEM There may be ...

Страница 54: ... meter is current NO SAMPLE DETECTED Either no sample or not enough sample was applied to the strip within 2 1 2 minutes after the Apply Sample message was displayed This can also happen if sample is applied on the strip but outside of the sample application well Repeat the entire procedure including fingerstick on a different finger with a new strip Apply the sample within 2 1 2 minutes after dis...

Страница 55: ...FAIL CLOT TIME TOO SHORT The clotting time was very short and out of testing range 8 seconds An air bubble was detected in the control activation solution sample The sample transfer tube was not filled with the control activation solution to the white plug Applying the control activation solution to the test strip before Apply Control Solution displayed on screen Repeat the entire procedure includ...

Страница 56: ... Taking too long to collect the sample in transfer tube make sure 21g needle lancets are used for good flow of blood Repeat the entire procedure including fingerstick on a different finger with a new strip Visually confirm that no air bubbles are in the sample before applying to test strip Depress black plunger completely to dispense the sample If the same message repeats contact Technical Support...

Страница 57: ...all socket General Troubleshooting Issue Possible Causes Solution Meter does not power ON Insufficient Battery to Power ON Power Adapter not connected properly for charging the battery Not pressing and holding Power button when turning meter on Check if the power adapter provided with the meter is connected to the port in the Meter and the wall socket If issue persists or if the power adapter is f...

Страница 58: ... the meter Check Battery level and if issue persists contact Technical Support Touch screen not responding Dropping or subjecting the meter to strong shocks Contact Technical Support Touch screen cracked Dropping or subjecting the meter to strong shocks Using pointed or sharp edged objects other than the recommended finger or rubber stylus to touch the screen elements Contact Technical Support Pow...

Страница 59: ...o perform the current test Alternately if you have additional inventory of the test strip kit from the same kit lot use the NFC tag from that box es NFC Tag Issues NFC tag not working Scanned informatio n does not match the informatio n on the strip packaging Improper scanning of the NFC tag Faulty NFC Tag scanner in the meter Touch or bring the NFC tag to proximity of the NFC Tag scanner If the i...

Страница 60: ... and Barcode on the test strip Scan the alternate NFC tag provided Touch or bring the NFC tag to proximity of the NFC Tag scanner If the issue persists enter the strip information manually into the touchscreen to perform the current test If you have more than one meter try scanning an NFC Tag on another meter to narrow down the root cause to either the tag or scanner If the issue persists contact ...

Страница 61: ...ct Technical Support at 1 866 903 0890 for instructions THIS WARRANTY APPLIES ONLY TO THE METER COAGUSENSE S ENTIRE LIABILITY IN CONNECTION WITH THE METER REGARDLESS OF THE LEGAL OR EQUITABLE BASIS OF ANY CLAIM IS LIMITED TO THE PURCHASE PRICE OF THE METER IN NO EVENT SHALL COAGUSENSE INC BE LIABLE TO THE PURCHASER FOR ANY INCIDENTAL CONSEQUENTIAL INCLUDING BUT NOT LIMITED TO LOSS OF INCOME OR PRO...

Страница 62: ...est Strip Kit Box of 50 03P56 50 Coag Sense Control Strip Kit 10 03P69 10 Sample Transfer Tubes with Plungers vial of 54 03P52 54 Sample Transfer Tubes with Preloaded Plungers vial of 54 03P52 55 Single Use 21g 2 2mm depth Auto Safety Lancets Box of 100 03P58 04 AC Power Adapter U S 03P74 01 Optional portable Printer 03P76 01 Thermal Printer Paper 2 PD 99906 Replacement Carrying Case 03P75 01 ...

Страница 63: ...e 2 61 D Date 40 Date and Time Setup 21 Detect Problem 49 Device Settings 20 E E Mail Support 61 Ethernet Port 4 Expected Values 11 External Connection 24 F Fingerstick Sample 31 H Hazards And Symbols 17 Heater Problem 50 High Control Strip 26 I Icons 8 IEC 60601 1 14 INR 4 INR Results 38 International Normalized Ratio INR 1 L Lancet 31 33 Language Setup 21 Liquid Problem 49 53 Low Control Strip 2...

Страница 64: ...set button 4 Room Temp Incorrect 48 S Software Update 44 Software Version Update 20 Sound Setting 22 Squeezing the Fingerstick Site 13 System Description 3 System Settings 19 T Target Range Setup 22 Test Strip 6 Time Zone Setup 22 Troubleshooting 48 U Unexpected results 39 User Settings 19 W Warnings and Precautions 12 Warranty 57 Wheel Problem 48 Wired Setting 24 Wireless Wi Fi Setting 23 ...

Страница 65: ...Blvd STE 113 Fremont CA 94538 USA Toll Free 1 866 903 0890 E Mail techsupport coagusense com CoaguSense Inc 48377 Fremont Blvd STE 113 Fremont CA 94538 USA Tel 510 270 5442 Fax 510 226 6540 Manufactured in South Korea CSI P N 200219 Rev AA 61010 01 ...

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