CoaguSense Assure PT Care Prothrombin Time User Manual
  1. Manuals
  2. Brands
  3. CoaguSense Manuals
  4. Measuring Instruments
  5. Assure PT Care Prothrombin Time
  6. User manual

CoaguSense Assure PT Care Prothrombin Time User Manual

Pt/inr monitoring system professional use
Hide thumbs
Table of Contents

Advertisement

Quick Links

Download this manual
A C O A G U S E N S E P A R T N E R
Assure
PT Care
®
Prothrombin Time
PT/INR Monitoring System
Professional Use
PRO
User Manual

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the Assure PT Care Prothrombin Time and is the answer not in the manual?

Questions and answers

Related Manuals for CoaguSense Assure PT Care Prothrombin Time

Summary of Contents for CoaguSense Assure PT Care Prothrombin Time

  • Page 1 A C O A G U S E N S E P A R T N E R Assure PT Care ® Prothrombin Time PT/INR Monitoring System Professional Use User Manual...
  • Page 2 No part of this publication may be reproduced, transmitted, transcribed, stored in a retrieval system or translated into any language or computer language, in any form or by any means, including, but not limited to, electronic, magnetic, optical, chemical, manual, or otherwise without written permission of ARKRAY USA.

  • Page 3: Table Of Contents

    Table of Contents 1. Introduction ..............1 2. System Description ............3 3. Meter Specifications .............11 4. Performance Characteristics ........13 5. Warnings and Precautions ..…........14 6. Hazards and Symbols …..........18 Directions for Use .............20 7. Meter Setup ....…..........20 8. Performing a Control Test …..........34 9.

  • Page 4: Introduction

    1. Introduction ® Assure PT Care Prothrombin Time (PT)/INR Monitoring System Intended Use ® The Assure PT Care Prothrombin Time (PT)/INR Monitoring System is an in vitro diagnostic device that provides quantitative prothrombin time (PT) results, expressed in seconds and International Normalized Ratio (INR) units. It uses fresh capillary whole blood.
  • Page 5 Important Information Regarding Manual ® The purpose of the Assure PT Care Prothrombin Time (PT)/INR Monitoring ® System User Manual is to help you understand your Assure PT Care PT/INR system, its parts, and its intended function. It provides you with the information you need to perform a PT test with the Assure ®...

  • Page 6: System Description

    2. System Description ® The Assure PT Care Prothrombin Time (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 ®...
  • Page 7 Meter: The meter has a TFT color LCD Touch screen that shows results, information, icons and results recalled from memory. To select an option, gently click on the display button. There are three touch buttons, Cancel or Previous Screen Button, Home Screen Button and View Menu Button Screen for the Guided User Interface (GUI) operation.
  • Page 8 Control Strips and Control Activation Solution Quality control is an important part of PT testing to verify the integrity of the ® performance characteristics of the testing system. The Assure PT Care Meter has been designed with multiple internal systems to ensure proper system function. When powered ON, the meter runs an extensive self-check protocol to ensure, for example, that operating temperature, timing functions, battery level and optical and mechanical functions are within specification.
  • Page 9 In the absence of NFC Tag, the user may manually enter the lot and Barcode number present on the strip packaging using the keypad on the touch screen. A stylus with a rubber capacitive tip may be used to facilitate typing. Power Supply and Battery: Assure ®...
  • Page 10 To perform a test, you require the following: ® • Assure PT Care Professional Test Strip Kit- 50 (Product 350218) is supplied with the following items: Item Description Patient Test Strips Low Control Strips High Control Strips Control Activation Solution Lot Info label Sample Transfer Tubes w/ plungers NFC Card...
  • Page 11 Overview of Buttons and Icons The buttons and icons that appear during normal operation are shown here, along with their respective meanings. Error messages and their descriptions are provided in “Troubleshooting” section. Buttons/Icons Meaning Power ON/OFF To power ON the meter, press and hold Power Button.
  • Page 12 Buttons/Icons Meaning The Status Bar: Current Date/Time Sound On/Off status Alarm – The presence or absence of set alarm Bluetooth On/Off status Wi-Fi On/Off Status Battery status Icons on the Touchscreen Back Icon - Go to previous screen Home Icon - Go to home screen when touched Settings Icon - Go to settings screen...
  • Page 13 Buttons/Icons Meaning Home Screen: Test Icon - Go forward to test screen when touched. Control Icon - Go forward to control test screen when touched. Results Icon - Go forward to result screen when touched. Settings Icon - Go forward to setup screen when touched.

  • Page 14: Meter Specifications

    3. Meter Specifications Operating Temperature 65°F to 90°F (18°C to 32°C) Operating Humidity 10% to 90% (without conden- sation) Storage Temperature 32°F to 122°F (0°C to 50°C) Storage Humidity 20% to 80% (without conden- sation) Altitude 10,000 ft (3,048 m) above sea level Memory Capable of storing up to:...
  • Page 15 Size in mm (Height x Width x Depth) 152 x 100 x 29.5 Weight in grams 315 grams Equipment Classification Class II with external power supply. Internally powered when operated with battery. IPX0 rating. ® WARNING: Use the Assure PT Care meter along with the provided Power Adapter only.

  • Page 16: Performance Characteristics

    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.

  • Page 17: Warnings And Precautions

    5. Warnings and Precautions WARNING: This test system is not recommended for patients who have recently taken or are currently taking any type of Heparin anticoagulants. The system should also not be used to monitor patients on direct oral anticoagulants (DOACs) including Factor Xa and Direct Thrombin inhibitors.
  • Page 18 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. • Do not use wipes containing chlorhexidine gluconate, as it may produce unreliable results.
  • Page 19 • Do not pull the strip out during a test 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 Assure PT Care PT/INR system following the instructions in this manual.
  • Page 20 PT Care Prothrombin Time (PT)/INR Monitoring System. The use of accessories, transducers and cables other than those specified • by ARKRAY USA, may result in increased EMISSIONS or decreased IMMUNITY of the EQUIPMENT. ® • The Assure PT Care Prothrombin Time (PT)/INR Monitoring System should not be used adjacent to or stacked with other equipment and if adjacent or ®...

  • Page 21: Hazards And Symbols

    6. Hazards and Symbols Caution is necessary when operating the device Class II Equipment. The Power Adapter is double insulated Biological risks: The strips and fingerstick materials should be disposed of in appropriate biohazard waste containers Indicates the date after which the medical device is not to be used Indicates the manufacturer’s batch code so that the batch or lot can be...
  • Page 22 The system fulfills the U.S. safety requirements (NEMKO listed) Consult instructions for use Near Field Communication (NFC) Tag Indicates the manufacturer’s serial number so that specific medical device can be identified Indicates a carrier that contains unique identifier information Bluetooth Connectivity, BLE Enabled Devices Wireless (Wi-Fi) Network To identify the country of manufacture...

  • Page 23: Directions For Use

    Directions for Use 7. Meter Setup Operating Conditions To ensure that your Assure ® PT Care PT/INR system is working correctly, be sure the following conditions are met: • Be sure that the meter and strips are at room temperature before use. Operating conditions are between 65ºF and 90ºF (18ºC and 32ºC).
  • Page 24 System and User Settings: The meter is set to default factory settings, English is the default language and time/time zone 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 functions.
  • Page 25 Image Guided Action Instruction Software Version Update See Device Information screen for version of software. If there is a new software version. The latest version can be found in this screen. Clicking the ‘New version’ will download the software update. A description of the software version to bring the system up-to-date or improve...
  • Page 26 Image Guided Action Instruction Device Setup Device Settings Screen Date/Time Settings Page 23...
  • Page 27 Image Guided Action Instruction Device Setup Date Settings Time Settings Language Settings Note: The default language is set to English. Sound Settings User chooses to Turn sound ON or OFF Page 24...
  • Page 28 Image Guided Action Instruction Sleep Settings Alarm Settings Theme Settings (User chooses Mono/Blue/Color) Date Format Settings Page 25...
  • Page 29 Image Guided Action Instruction Time Format Settings Time Zone Settings Brightness Settings User chooses from range of 1-7 (1 is the darkest, 7 is the brightest). Target Range Settings Page 26...
  • Page 30 Image Guided Action Instruction Administrator Password Setup Communication Settings The screen lists the status of the communication channels. The forward button on each type will direct the User to a detailed view. Communication settings (Admin or User) If connected to the Wireless, touchscreen displays the name of the Wi-Fi network.
  • Page 31 Image Guided Action Instruction Upon clicking the ‘Setup’ icon. The touchscreen displays the Wireless Information screen. Select a connection method. Input into the fields for the wireless network information, i.e., IP address, Mask, Router and DNS server. Click ‘Confirm’ to proceed and enter the security password for connecting to a network.
  • Page 32 Image Guided Action Instruction Wired Settings If the connection method is DCHP, the contents are filled when the network with the DHCP server is plugged in. Bluetooth Bluetooth Select Menu Connect cell. 23-1. Set the external device ready to connect to the Assure ®...
  • Page 33 Image Guided Action Instruction Reset Bluetooth Paired Devices. 24-1. Reset and connect cell. Reset Bluetooth paired devices pop-up Broadcast Bluetooth will pair the ® Assure PT Care PT/INR meter to an external device. Set the external device ready to connect to the PT/INR meter.
  • Page 34 Image Guided Action Instruction Admin Settings Admin settings Automatic login settings. Set whether enter Patient ID is required. Set STAT test enable. Set the need for a User Password (password is optional to login). QC Lock settings (Control Test Fail, period).
  • Page 35 Image Guided Action Instruction User Management User Management screen displays the user ‘Admin’ account that was previously set up (Initial Setting Section) is on the top. Create user button (touchscreen). Edit the administration screen. Edit team. Delete user account button, confirm deletion when pop-up appears for selection of user to delete when touched.
  • Page 36 QC Lockout (Optional Settings): When the optional QC Lockout feature is turned on, a control test must be completed before a patient test can be performed. The QC Lockout ensures compliance with facility policy by checking that quality control tests are run at the required (Admin User defined) frequency.

  • Page 37: Performing A Control Test

    8. Performing a Control Test There are 2 Low Control Strips, 2 High Control Strips and a Control Activation Solution shipped with each test strip kit. Controls should be tested immediately upon receipt of each new lot number. Extra Controls may be ordered separately if more frequent QC testing is required.
  • Page 38 Follow these steps to perform a test on a Low or High Control. Image Guided Action Instruction Power the meter ON by pressing and holding the (POWER) button on the right side of the meter. Message display cell STAT Button Login Button Setup Button Note: The message field on the first screen...
  • Page 39 Image Guided Action Instruction Successful login directs the user to the Home screen. Press the Control icon on the display. Test. Go forward to Test screen when touched. Control Test. Go forward to Control test screen when touched. Results. Go to forward to Results screen when touched.
  • Page 40 Image Guided Action Instruction Strip lot confirmation screen displays the Lot information of the strip that was last recorded. Proceed with testing if the control strip is from the same lot. Low Control Test Strip lot confirmation If the Lot information does not match, press Change and scan the NFC Tag against the NFC Tag scanner on the meter.
  • Page 41 Image Guided Action Instruction Holding the round end, gently push the strip completely into the meter. The strip fits snugly when pushed all the way toward the back wall of the strip insertion area. The meter warms the strip (for 25 seconds) to operating temperature, the display shows a countdown in seconds.
  • Page 42 Image Guided Action Instruction When the Control Activation Solution is properly applied and detected, the flashing green light will turn off, and the meter displays ‘Testing Please Wait’. Note: If this screen is not displayed within 8 seconds not enough solution was applied. Remove the strip.

  • Page 43: Collecting A Fingerstick Sample

    9. Collecting a Fingerstick Sample Tips for a Successful Fingerstick • Make sure that you have all the supplies needed before you start. • 21g Lancet device (Single use, auto disabling) • Sample Transfer Tubes • Sterile alcohol prep pads •...
  • Page 44 WARNING: Patient samples, controls, used test strips, transfer tubes, and lancets are potentially infectious. Dispose of the strips and collection devices using universal precautions. Image Guided Action Instruction Have patient wash their hands with soap and warm water. Dry completely. If using an alcohol wipe, the finger must be wiped dry with sterile gauze (air drying is insufficient to...
  • Page 45 WARNING: Squeezing the fingerstick site excessively (milking) releases interstitial “tissue layer” fluid that causes unreliable results. Image Guided Action Instruction When ready to collect the drop of blood, hold the Sample Transfer Tube horizontally. Touch tip to bead of blood and let capillary action fill until blood flow stops at green band.

  • Page 46: Performing A Pt Test

    10. Performing a PT Test WARNING: Place the meter on a stationary, level surface for testing. DO NOT move the meter or allow it to vibrate during the test. Unreliable results may occur. Wear gloves and follow all applicable hygiene and safety procedures. Follow the below steps to perform a patient test: Image Guided Action...
  • Page 47 Image Guided Action Instruction 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, press Change and scan the NFC Tag against the NFC Tag scanner on the meter, the Lot # (six-digit number) and Barcode # (eight-digit number) will...
  • Page 48 Image Guided Action Instruction 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 sample.’ While the meter is warming up, get ready to perform a fingerstick See “Collecting a Fingerstick Sample”...
  • Page 49 Image Guided Action Instruction When testing is complete, the meter beeps (if sound is turned ON). The results (INR and PT seconds) are displayed on the screen along with the date and time of the test. Note: Memo field allows user to make notes along with the results.
  • Page 50 WARNING: An unexpected result may include any result that falls outside the patient’s therapeutic target range, or a result that falls inside the target range but is not consistent with the patient’s current health status (e.g., patient is experiencing bleeding or bruising). What can cause unexpected results: Certain prescription drugs (for example, heparin) and certain over-the- counter medications can affect the action of oral blood thinners and the...

  • Page 51: Performing A Stat Test

    11. Performing a STAT Test A STAT Test allows the user to perform and obtain results of a patient test without logging in a User account or entering a Patient ID. STAT test results are saved in the memory of the meter with Patient ID as STAT, along with patient result it also records the date and time the test was performed.
  • Page 52 Image Guided Action Instruction Note: Make sure the expiration date on the strip packaging has not ® passed. Contact your Assure Care representative for help with reordering. Open the packaging of the test strip by tearing the notched end. Holding the round end, gently push the strip completely into the meter.
  • Page 53 Image Guided Action Instruction IMMEDIATELY after collecting the patient sample, place the tip of the sample transfer tube 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.

  • Page 54: Reviewing The Memory

    12. Reviewing the Memory ® The Assure PT Care meter stores up to 2000 patient test results and 500 control test results, along with the respective date and time of the test performed. When the memory has reached maximum storage capacity, the oldest result is automatically deleted and gets replaced with the most recent result.
  • Page 55 Image Guided Action Instruction The ‘Results’ screen lists Patient test results and Control test results. User can select from the various results stored in memory to view details of that results. User can filter and view test results for a specific Patient Identifier by clicking on the Show Results of History button.

  • Page 56: Printing

    13. Printing With the portable printer (optional accessory) available from ARKRAY USA, results ® from the Assure PT Care meter memory can be printed on either thermal paper or other media such as thermal labels for applying to patient charts. Note: Contact your ARKRAY representative to order accessories such as the printer and paper.
  • Page 57 Image Guided Action Instruction User may choose from three different printer connection modes. Network and Bluetooth connection modes will require configuration using the setup icon prior to printing. Press Print to print the result. If the results fail to print, confirm that the printer is ON and charged as it automatically turns OFF after a few minutes.

  • Page 58: Network Connectivity And Security

    14. Network Connectivity and Security ® The Assure PT Care meter offers the ability to send patient test results to ® electronic medical records or laboratory information systems. The Assure Care meter can be connected to a Local Area Network (LAN) via either a direct Ethernet connection or wirelessly using Wi-Fi.

  • Page 59: Meter Software Update

    15. Meter Software Update ® When connected to the Internet, the Assure PT Care meter can check for the availability of meter software updates which can be downloaded. If the meter is not continuously connected to the Internet, you should make it a practice to periodically connect the meter to the Internet to check for software updates.

  • Page 60: Battery

    16. Battery ® The Assure PT Care Meter has a factory installed Rechargeable Lithium Polymer Battery, that charges when the power adapter (provided with the meter) is plugged into the wall socket. A charged battery (6 hours to fully charge) can run approximately 100 tests.

  • Page 61: Cleaning And Disinfecting The Meter

    17. Cleaning and Disinfecting the Meter No maintenance is required other than routine cleaning and/or disinfecting. When the power is off and the USB cable is not connected, the meter housing can be cleaned and disinfected. Wipe all exposed surfaces with Healthcare Bleach Germicidal Wipes containing Sodium Hypochlorite (EPA No.
  • Page 62 WARNING: Do not put the meter in liquid. Do not allow liquids to get inside the meter or into any of the connectors or plugs on the meter. If you suspect any physical damage or deterioration of the meter (such as cracking or gross distortion), or if the meter does not turn on after cleaning, call Technical Support at 800.818.8877.

  • Page 63: Troubleshooting

    18. Troubleshooting ® The Assure PT Care Meter continually checks its systems for unexpected conditions. These may arise because of defective components or consumables, environmental factors or due to user handling and procedure errors. This section details how to resolve most problems that you might encounter. If you have any questions or problems during the troubleshooting process, note the display wording and contact ARKRAY Technical Support at technicalsupport@arkrayusa.
  • Page 64 Meter Display Possible Cause(s) Solution HEATER The meter is too warm, too Move the meter to a place that is PROBLEM cold, or there may be a within the operating temperature problem with the meter. range of the meter (65ºF to 90ºF, 18ºC to 32ºC) and allow meter time to adjust to correct temperature.
  • Page 65 Meter Display Possible Cause(s) Solution STRIP ERROR The strip was inserted Take the strip out and reinsert incorrectly. holding the back of the instrument steady with one There may be a problem with hand while inserting the strip the strip or meter. completely with the other hand.
  • Page 66 Meter Display Possible Cause(s) Solution CONTROL There was no clot Repeat the entire procedure with a FAIL-NO CLOT formation; sample clotting new control strip. If the same message DETECTED time was very long and persists and if you have additional out of testing range.
  • Page 67 Meter Display Possible Cause(s) Solution CONTROL FAIL- The control strip result is Repeat test with another control OUT OF RANGE outside of its acceptable strip. If the second test is out range (FAIL-out of range). of range, contact Technical This may be due to a Support.
  • Page 68 BATTERY LOW/ The meter battery is low. Connect power adapter into DISPLAY IS the wall socket at least for 30 BLANK minutes to use it for testing. The meter will take 6 hours to charge fully. Verify that the battery is getting charged by checking the charging indications (green lightning bolt on...
  • Page 69 Meter Display Possible Cause(s) Solution Cannot insert strip Accumulation of dirt, dust, Contact Technical Support for completely control activation solution, assistance with cleaning the strip or blood in the strip insertion area. insertion area. Use your thumbnails to push wheel Wheel is not seated spindles down to snap wheel into properly into of test strip.
  • Page 70 Meter Display Possible Cause(s) Solution Lost NFC Tag Misplaced NFC Tag. The NFC Tag is provided with each test strip kit box. Otherwise, enter the strip information manually into the touchscreen to 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.

  • Page 71: Warranty

    19. Warranty Limited One (1) Year Warranty ® Use of the Assure PT Care PT/INR System ® The Assure PT Care PT/INR system is designed for use in monitoring patients on oral anticoagulant therapy. Proper adherence to the instructions in this User Manual and package insert are critical to proper operation.
  • Page 72 ® PURPOSE IS IMPLIED FROM THE SALE OF THE ASSURE PT CARE PT/INR SYSTEM. NO WARRANTY, EXPRESS OR IMPLIED (IF ANY) SHALL EXTEND FOR A LONGER DURATION THAN THE DURATION OF THE EXPRESS WARRANTY STATED ABOVE. Instructions for Meter’s Return If there is an issue with the Meter, you agree to a telephone consultation with ARKRAY’s Technical Service to attempt to remedy the issue.

  • Page 73: Reordering Information

    20. Reordering Information For a description of the products listed below, please see the information above. Product Product # ® Assure PT Care PT/INR Professional System 350222 ® Assure PT Care Test Strip Kit, Box of 50 350218 Sample Transfer Tubes with Preloaded Plungers, 1 pack 05P52-57 ®...

  • Page 74: Emc Tables

    21. EMC Tables The following tables contain the Manufacturer’s declaration and additional information required by IEC 60601-2:2014 (Fourth Edition). Ref. AC Mains Test Level Test Name Ports to Test Notes Standard Voltage Required Mains CISPR AC Mains 100V-50Hz Group I, Terminal 11:2015±...
  • Page 75 Ref. AC Mains Test Level Test Name Ports to Test Notes Standard Voltage Required Conducted EC 61000- AC Mains 230V-50Hz 3Vrms Dwell time is Disturbances, 6:2013 & all I/O 150kHz to 3 sec Induced by RF 80MHz fields 6Vrms in ISM Amateur radio bands between 0.15MHz &...

  • Page 76: Index

    22. Index Admin Settings 31 Email support 2, 75 Alarm 9, 25 EMC Tables 71 Alcohol wipes 7 Ethernet Port 4 Expected Values 13 External Server Connection 30 Battery 6, 9, 11, 57, 60, 65, 66 Battery Low 65 Blood Flow 40, 42, 64 Fingerstick Sample 14, 40, 45, 49 Bluetooth Settings 9, 19, 27, 29, 30, Brightness 26...
  • Page 77 Measuring Range 13 SHARPS container 7 Memory 11, 46, 51 Sleep Settings 25, 31 Meter does not power ON 65 Software Update 56 Meter Setup 20 Software Version Update 22 Meter Specifications 11 Sound Settings 24 Squeezing the fingerstick site 14, 42 Motor Problem 62 STAT Test 31, 35, 48, 51, 52 System and User Settings 21...
  • Page 78 Distributed By: ARKRAY USA, Inc. 5182 West 76th Street Minneapolis, MN 55439 800.818.8877 Manufactured By: CoaguSense, Inc. 48377 Fremont Blvd., Ste 113 Fremont, CA 94538 Made in Korea Caution: Federal law restricts this device to sale by or on the order of a physician.
  • Page 79 In vitro diagnostic medical device 61010-1 ARKRAY P/N 5695-00 Rev. 05/23 Patent 7,235,213 CSI P/N 500008, Rev. AA Edition: May 2023 Page 76...

Table of Contents