Abbott Precision XceedPro Operator's Manual
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Abbott Precision XceedPro Operator's Manual

Precision xceedpro blood glucose monitoring operator’s manual
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Operator's Manual
for Blood Glucose Monitoring
Abbott Diabetes Care Inc.
1360 South Loop Road
Alameda, CA 94502 USA
Precision Xceed Pro, TrueID, TrueMeasure, TrueAccess, PrecisionWeb, Precision, MediSense
and Precision PCx are trademarks of the Abbott Group of Companies. Other trademarks
are the property of their respective owners.
© 2007 Abbott
ART14576 Rev. A 11/07
Point of Care System

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Summary of Contents for Abbott Precision XceedPro

  • Page 1 1360 South Loop Road Alameda, CA 94502 USA Precision Xceed Pro, TrueID, TrueMeasure, TrueAccess, PrecisionWeb, Precision, MediSense and Precision PCx are trademarks of the Abbott Group of Companies. Other trademarks are the property of their respective owners. © 2007 Abbott...

  • Page 2: Table Of Contents

    Table of Contents This Operator's Manual provides basic information about the Precision Xceed Pro System. It is organized into three sections. First, the overview in Chapter 1 describes the components of the Precision Xceed Pro System and the physical features of the monitor. Next, Chapters 2 through 8 give step-by-step procedures to operate the monitor.
  • Page 3 Troubleshooting Out-of-Range Control Test Results ........................10-1 Troubleshooting Out-of-Range Linearity Test Results .........................10-2 Error Messages ....................................10-2 Technical Support Instructions ...............................10-9 Returning an Instrument .................................10-9 Contacting Abbott for Service ...............................10-10 11. Maintenance ................................11 Cleaning the Exterior Surface ................................11-1 Replacing the Port Protector ................................11-2 Battery Life......................................11-2 Replacing the Batteries ..................................11-2...

  • Page 4: Overview

    1. Overview Intended Use TrueID, TrueMeasure, and TrueAccess Icons and Warnings Conventions System Components...
  • Page 5 Overview Intended Use The Precision Xceed Pro Point of Care System for Blood Glucose Testing is intended for in vitro (outside the body) diagnostic use for the quantitative measurement of glucose in fresh capillary whole blood. The Precision Xceed Pro System is for home (lay user) or professional use.
  • Page 6 Icons and Warnings Information that is of particular relevance to the reader is called out in gray boxes throughout the manual, with an appropriate icon and warning level. IMPORTANT: Indicates that inconvenience to the operator or danger to the patient may result if the instruction is not followed.

  • Page 7: System Components

    System Components The Precision Xceed Pro Monitor is part of an overall system designed to simplify point of care testing. Port These components are purchased separately and some are optional. Protector Precision Xceed Pro System Components Test Strip Port The Precision Xceed Pro System includes the following items: •...
  • Page 8 Precision PCx Plus Blood Glucose Test Strips use proprietary glucose-specific chemistry that includes the glucose dehydrogenase enzyme, NAD cofactor and PQ mediator (GDH-NAD/PQ). This chemistry is used for testing glucose because it is not affected by maltose, icodextrin, and other common substances at normal therapeutic levels. It also ensures minimal measurement bias from oxygen, hematocrit and other physiological variables.
  • Page 9 There is no need to prep the monitor prior to using the bag and the bag does not affect any monitor functions. Note that Abbott Isolation Bags are not sterilized.

  • Page 10: Using The Monitor

    2. Using the Monitor Barcode Scanner Data Entry Keypad Audible Indicator Data Port Battery Compartment Port Protector Monitor Identification Menu Tree...

  • Page 11: Barcode Scanner

    Using the Monitor Barcode Scanner The barcode scanner enables you to scan the information into the monitor instead of manually entering the data using the keypad. Scanning the barcode on the test strip foil packet automatically enters the test strip information (calibration, control range, lot number and expiration date).

  • Page 12: Audible Indicator

    On/Off Press this button to turn the monitor on. Each time the monitor is turned on, the Abbott logo screen will appear in black for a few seconds and then will appear in gray. This provides an opportunity to ensure that all the pixels are working correctly.

  • Page 13: Monitor Identification

    Monitor Identification Each monitor has a unique serial number listed on the back of the device just below the battery compartment. The Precision Xceed Pro Monitor also features an untextured area on the side of the device. This .875 inch [22 mm] wide x .483 inch [11 mm] high area allows a facility to apply a label with information pertaining to the monitor.

  • Page 14: Patient Test

    3. Patient Test Operating Guidelines for All Samples Collecting Blood Samples How to Obtain a Capillary Blood Sample How to Obtain a Venous Blood Sample How to Obtain an Arterial Blood Sample How to Obtain a Neonatal Capillary Blood Sample Disposing of Waste Patient Test Procedure - Glucose...
  • Page 15 Patient Test This chapter describes the steps to be taken to test patient blood glucose levels in fresh whole blood using the Precision Xceed Pro System. Inside each box of test strips is a package insert with detailed instructions for use. Operating Guidelines for All Samples Please follow the recommended guidelines for the most accurate results: •...

  • Page 16: How To Obtain A Neonatal Capillary Blood Sample

    Collecting Blood Samples How to Obtain a Capillary Blood Sample: • Use only fresh whole blood samples. • Make sure that the sampling site is clean and dry before lancing. • Collect the capillary blood using a lancing device and an appropriate technique. •...

  • Page 17: Patient Test Procedure - Glucose

    What You Do Comments 1. Press On/Off to turn on the monitor. The Abbott logo screen will appear in black for a few seconds and then will appear in gray to ensure that the display is functioning properly. Next, the software version and then the Test Mode menu screens will appear.
  • Page 18 What You See on the Display What You Do Comments Press 2 to Confirm the information and continue testing or 1 to ReEnter the ID. Enter the year of birth (e.g. 63) and press Press Clear to re-enter the ID. If numbers have Enter.
  • Page 19 What You See on the Display What You Do Comments Prior to inserting the test strip, ensure that the 9. With the contact bars facing up, insert the port protector is installed and that it is clean test strip into the test strip port until and dry.
  • Page 20 What You See on the Display What You Do Comments For out-of-range results, refer to your The Action Range screen will appear if the institution's policy. Patient Test Out-of-Range Comment Code is enabled and the following two conditions are met: A.

  • Page 21: Control Test

    4. Control Test Operating Guidelines for Control Solution Testing Control Test Procedure - Glucose...

  • Page 22: Operating Guidelines For Control Solution Testing

    Control Test This chapter describes the steps for running a control test with control solutions. Control tests verify the performance of the Precision Xceed Pro Monitor and Test Strips. The quality control features of the monitor can be customized to fit the requirements of each facility. The monitor can be set to require: • Tests of low, normal and high control solutions or a variation depending on the facility’s policy.
  • Page 23 What You See on the Display What You Do Comments The Abbott logo screen will appear in black 1. Press On/Off to turn on the monitor. for a few seconds and then will appear in gray to ensure that the display is functioning properly.
  • Page 24 What You See on the Display What You Do Comments 5. Press Scan to scan the test strip barcode or Scanning the barcode identifies the strip manually enter the test strip lot number via type, calibrates the monitor, ensures the the keypad, then press Enter.
  • Page 25 What You See on the Display What You Do Comments 9. Wait for the monitor to analyze the sample The monitor counts down then displays the test result. If an error is detected during and display the test result. the assay, the assay is terminated and no result is displayed.

  • Page 26: Data Review

    5. Data Review Data Review for Patient by Operator ID Data Review for Patient by Patient ID Data Review for All Patient Data Data Review for Control Data Data Review for Proficiency Data Data Review for Linearity Data...
  • Page 27 Data Review The Precision Xceed Pro Monitor stores the results of up to 2,500 patient tests, 1,000 control tests, 20 proficiency tests and 1 linearity panel. This data can be retrieved by the following categories: Patient by Operator ID (OperID): This will show test results performed by a particular operator, starting with the most recent test.
  • Page 28 What You Do Comments 1. Press the On/Off button to turn the The Abbott logo screen will appear in black for a few seconds and then will appear in gray to monitor on. ensure that the display is functioning properly.

  • Page 29: Data Review For Patient By Operator Id

    Data Review for Patient by Operator ID Please refer to the beginning of this Data Review chapter for step-by-step instructions to access the Data Review menu. Note: The following section illustrates some common settings. Depending on your institution's specific settings, some screens will display differently or not at all.

  • Page 30: Data Review For Patient By Patient Id

    Data Review for Patient by Patient ID Please refer to the beginning of this Data Review chapter for step-by-step instructions to access the Data Review menu. Note: The following section illustrates some common settings. Depending on your institution's specific settings, some screens will display differently or not at all.
  • Page 31 Data Review for All Patient Data Please refer to the beginning of this Data Review chapter for step-by-step instructions to access the Data Review menu. Note: The following section illustrates some common settings. Depending on your institution's specific settings, some screens will display differently or not at all. If the monitor does not display the screens shown, please refer to Chapter 10, Troubleshooting.
  • Page 32 Data Review for Control Data The monitor stores the last 1000 control test results. Please refer to the beginning of this Data Review chapter for step-by-step instructions to access the Data Review menu. Note: The following section illustrates some common settings. Depending on your institution's specific settings, some screens will display differently or not at all.
  • Page 33 Data Review for Proficiency Data The monitor stores the last 20 proficiency test results. Please refer to the beginning of this Data Review chapter for step-by-step instructions to access the Data Review menu. Note: The following section illustrates some common settings. Depending on your institution's specific settings, some screens will display differently or not at all.
  • Page 34 Data Review for Linearity Data The monitor stores the last linearity panel that includes a maximum of 4 replicates for 5 levels (20 tests). Please refer to the beginning of this Data Review chapter for step-by-step instructions to access the Data Review menu. Note: The following section illustrates some common settings.

  • Page 35: Proficiency Test

    6. Proficiency Test...
  • Page 36 IMPORTANT: Patient testing should be run in patient test mode only. What You See on the Display What You Do Comments The Abbott logo screen will appear in black for 1. Press the On/Off button to turn on the monitor. a few seconds and then will appear in gray to ensure that the display is functioning properly.
  • Page 37 What You See on the Display What You Do Comments Scanning the barcode identifies the strip type, 6. Press Scan to scan the test strip barcode or manually enter the test strip lot number via calibrates the monitor, ensures the expiry date the keypad, then press Enter.
  • Page 38 What You See on the Display What You Do Comments 9. Bring proficiency survey specimens to When sufficient sample has been applied, the room temperature. Mix each specimen well monitor beeps, displays Sample Accepted according to instructions from the survey and automatically starts the test.

  • Page 39: Linearity Test

    7. Linearity Test...
  • Page 40 What You Do Comments 1. Press On/Off to turn on monitor. The Abbott logo screen will appear in black for a few seconds and then will appear in gray to ensure that the display is functioning properly. Next, the software version and then the Test Mode menu screens will appear.
  • Page 41 What You See on the Display What You Do Comments 5. Scan or manually enter the CVC kit lot LIN stands for Linearity. number via the keypad, then press Enter. 6. If the New Panel screen appears you If the CVC kit lot number that was entered is different from the previous one, the monitor may either: will prompt you to do one of two actions:...
  • Page 42 What You See on the Display What You Do Comments Scanning the barcode identifies the strip type, 8. Press Scan to scan the test strip barcode or manually enter the test strip lot number via calibrates the monitor, ensures the expiry date the keypad, then press Enter.
  • Page 43 What You See on the Display What You Do Comments 11. Follow the instructions in the CVC kit When sufficient sample has been applied, the package insert. Then apply a drop of the monitor beeps, displays Sample Accepted sample to the target area. and automatically starts the test.

  • Page 44: Review Setup

    8. Review Setup Monitor Configuration Review Setup Review Test Setup for All Tests Review Test Setup for Test Type Review Test Setup for Patient Test Review Test Setup for Control Test Review Test Setup for Security System Status...
  • Page 45 Review Setup Monitor Configuration The Precision Xceed Pro Monitor configuration settings are enabled via the data management system. These settings can be viewed on the hand-held device, but cannot be changed on it. Settings that are configured through the data management system are: Upload interval •...
  • Page 46 Control Tests • Set which levels of control solution are required, optional, or not used by your facility. The monitor can be configured to run any combination of low, mid, and high control solution tests. • Set whether control solution test results display as numeric or as Pass/Fail. •...

  • Page 47: Review Setup

    What You Do Comments 1. Press On/Off to turn on the monitor. The Abbott logo screen will appear in black for a few seconds and then will appear in gray to ensure that the display is functioning properly. Next, the software version and then the Test Mode menu screens will appear.

  • Page 48: Review Test Setup For All Tests

    Review Test Setup for All Tests Note: This section illustrates some representative settings. If the monitor does not display these screens, please refer to Chapter 10, Troubleshooting. What You See on the Display What You Do Comments 1. Press 1 for Test Setup. 2.

  • Page 49: Review Test Setup For Test Type

    Review Test Setup for Test Type Note: This section illustrates some representative settings. If the monitor does not display these screens, please refer to Chapter 10, Troubleshooting. What You See on the Display What You Do Comments 1. Press 1 for Test Setup. 2.

  • Page 50: Review Test Setup For Patient Test

    Review Test Setup for Patient Test Note: This section illustrates some representative settings. If the monitor does not display these screens, please refer to Chapter 10, Troubleshooting. What You See on the Display What You Do Comments 1. Press 1 for Test Setup. 2.

  • Page 51: Review Test Setup For Control Test

    Review Test Setup for Control Test Note: This section illustrates some representative settings. If the monitor does not display these screens, please refer to Chapter 10, Troubleshooting. What You See on the Display What You Do Comments 1. Press 1 for Test Setup. 2.

  • Page 52: Review Test Setup For Security

    Review Test Setup for Security Note: This section illustrates some representative settings. If the monitor does not display these screens, please refer to Chapter 10, Troubleshooting. What You See on the Display What You Do Comments 1. Press 1 for Test Setup. 2.

  • Page 53: System Status

    What You See on the Display What You Do Comments The Abbott logo screen will appear in black 1. Press On/Off to turn on the monitor. for a few seconds and then will appear in gray to ensure that the display is functioning properly.
  • Page 54 What You See on the Display What You Do Comments 7. Press 1-Next to continue to the System Status Date screen. 8. Press 1-Next to continue to the System Status Software Version and Serial Number screen. The number that appears on your monitor 9.

  • Page 55: Data Upload

    9. Data Upload Docking Station Connecting Cables to the Docking Station Mounting Instructions...
  • Page 56 Data Upload Once the test results have been collected during a prescribed period of time, they can be uploaded into the data management system. The data management system provides a simple and automated way to collect, report and transfer data. To start the upload of data, simply place the Precision Xceed Pro Monitor into the docking station.
  • Page 57 Abbott Diabetes Care (ADC). The Precision Xceed Pro Monitor is compatible with older Abbott docking stations that have LED lights, lit with an optional AC Adapter. The following LED information applies only to older docking stations.

  • Page 58: Mounting Instructions

    1. Connect the RS-232 cable to a serial port on a networked PC at the nurses’ station and to the docking station data transfer port. 2. Ensure that the Networked PC has power and a working network connection. Instructions for installing Abbott Data Repeater are available separately.

  • Page 59: Troubleshooting

    10. Troubleshooting Troubleshooting Patient Test Results Troubleshooting Out-of-Range Control Test Results Troubleshooting Out-of-Range Linearity Test Results Error Messages Technical Support Instructions Returning an Instrument Contacting Abbott for Service...

  • Page 60: Troubleshooting Patient Test Results

    If test results appear higher or lower than expected for reasons not described above, please repeat the test using a new test strip. If the results still appear higher or lower than expected, call Abbott Technical Support at 1-877-529-7185. Outside the United States, contact your local Abbott Diabetes Care office or distributor.

  • Page 61: Troubleshooting Out-Of-Range Linearity Test Results

    If test results are out of range despite meeting the above criteria, please repeat the test using a new CVC kit and/or test strips. If the results are still out of range, call Abbott Technical Support at 1-877-529-7185. Outside the United States , contact your local Abbott Diabetes Care office or distributor.
  • Page 62 Note: Check the Precision Xceed Pro display for proper performance before every test. If at any time the display screen becomes difficult to read, discontinue use of monitor and call Abbott Technical Support or your local Abbott office or distributor.
  • Page 63 When a Test is Selected: Symptom/Error Message Explanation How To Respond The QC Interval Controls Expired Perform the remaining control tests indicated option is set to Warn or Lockout and in the message. one or more control tests is past due. (The menu item 2 –...
  • Page 64 During Any Test: Symptom/Error Message Explanation How To Respond The barcode just scanned was not read 1. Re-enter the lot number using the barcode correctly. Possible reasons are: scanner or keypad. • T he red scanner beam did not pass across all 2. Notify the system administrator. The the bars of the code.
  • Page 65 Symptom/Error Message Explanation How To Respond The Operator ID just entered is not on the 1. Press 1 to ReEnter the ID using the list of acceptable Operator ID’s defined barcode scanner or keypad. for this monitor. (The menu items 2 – Continue appear Press 2 to Continue.
  • Page 66 1. Press 1 to repeat the test with a New Strip One of several 4-digit error codes may or 2 to Exit. be displayed. These codes provide Abbott personnel additional information about the 2. If the error occurs again, record the problem.
  • Page 67 Symptom/Error Message Explanation How To Respond When a Control Test is selected: A control solution lot number has been Press 1 to ReEnter the lot. entered for a different level of control test from the one that the monitor expected to run Press 2 to run the level of test that matches the (in the usual low-to-high sequence).

  • Page 68: Technical Support Instructions

    Technical Support Instructions Abbott Technical Support contact information is listed on the following two pages. When you call, an Abbott representative will address the problem and/or instruct you to return the monitor, test strips, control solution and/or linearity kit. Do not return the Precision Xceed Pro Monitor or any part of the system for repair until you receive authorization from an Abbott representative.

  • Page 69: Contacting Abbott For Service

    Contacting Abbott for Service Abbott is committed to helping you resolve any problems with the Precision Xceed Pro Point of Care System. For technical assistance, please call Abbott Technical Support at 1-877-529-7185, twenty-four (24) hours per day. Outside the United States, contact your local office or distributor listed below.
  • Page 70 LATIN AMERICA MIDDLE EAST AND AFRICA NORTH AMERICA Argentina Israel Canada Abbott Laboratorios de Argentina SA ILEX Medical Ltd. Abbott Diabetes Care Buenos Aires, Argentina Rosh-Ha'ayin, Israel Mississauga, Ontario, Canada Tel: +0800-800-6334 Tel: +972-3-938-5501 Tel: +1-800-387-8378 (English) Tel: +1-800-465-2675 (French)

  • Page 71: Maintenance

    11. Maintenance Cleaning the Exterior Surface Replacing the Port Protector Battery Life Replacing the Batteries...
  • Page 72 Cleaning solutions not listed have not been tested and may damage the monitor. Contact Abbott Technical Support or your local Abbott office or distributor for the most up-to-date information on cleaning solutions.

  • Page 73: Battery Life

    Use the following procedure to install new batteries in the Precision Xceed Pro Monitor. The Precision Xceed Pro Monitor requires two (2) AA alkaline batteries or nickel-metal hydride (NiMH) rechargeable batteries (not supplied by Abbott Diabetes Care). 1. Turn the Precision Xceed Pro Monitor off by pressing the On/Off button on the keypad.

  • Page 74: Specifications

    12. Specifications Precision PCx Plus Test Strips Precision Xceed Pro Monitor Symbols Barcode Types Important Safety Instructions...

  • Page 75: Specifications

    256 grams (9 ounces) Power Source: Two standard alkaline AA batteries or nickel-metal hydride (NiMH) rechargeable batteries (not supplied by Abbott Diabetes Care). Battery performance is a function of how often the monitor is used and the duration time that testing is conducted.

  • Page 76: Symbols

    Symbols There are special symbols that appear on the Precision Xceed Pro Monitor and docking station. The complete list of symbols and explanations are listed below. Please note: Some of the symbols listed below will not appear on your Precision Xceed Pro Monitor and docking station due to differences in local regulatory requirements.

  • Page 77: Barcode Types

    Date of Manufacture Do not drink Legal Manufacturer under In Vitro Diagnostic Medical Devices Directive 98/79/EC - Abbott Diabetes Care. Consult instructions for use. Recyclable. For in vitro diagnostic use only. Method of sterility for Lancets only. Sterilized using irradiation (Lancets only).

  • Page 78: Important Safety Instructions

    RSS: RSS is an abbreviation for Reduced Symbology Set, which produces very small barcodes suitable for labeling electronic components and healthcare devices. There are seven different types of RSS barcodes. RSS can encode at maximum 74 characters. Note: Control characters and non-alphanumeric characters (e.g. $) are displayed as spaces in the Precision Xceed Pro Monitor.
  • Page 79 Standards Compliance The Precision Xceed Pro Point of Care System has been evaluated against the following standards: UL 60601-1, 1st ed. Medical Electrical Equipment—Part 1: General Requirements for Safety CSA C22.2 No. 601.1-M90, Medical Electrical Equipment - Part 1: General Requirements for Safety EN 60601-1, 2nd ed., Medical Electrical Equipment—Part 1: General Requirements for Safety CSA 22.2 No.

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