Roche CoaguChek XS System Manual de usuario Pagina 1

CoaguChek® XS PlusSystemUser Manual

Operating conditionsTo be sure that your CoaguChek XS Plus System functions properly, please observe the following guidelines:n Only use the meter at

Further information100this section to claim rights or contest your rights to work written entirely by you; rather, the intent is to exercise the right

Further information1015. You are not required to accept this License, since you have not signed it. However, nothing else grants you permission to mod

Further information1029. The Free Software Foundation may publish revised and/or new versions of the General Public License from time to time. Such ne

Further information103How to Apply These Terms to Your New Programs If you develop a new program, and you want it to be of the greatest possible use t

Further information104This software was developed by the Computer Systems Engineering group at Lawrence Berkeley Laboratory under DARPA contract BG 91

Operating conditions and technical dataTemperature range 59°F to 90°F (15°C to 32°C)Relative humidity 10% to 85% (no condensation)Maximum altitude

Sample materialSample type Capillary whole blood or non-anticoagulated venous whole blood.Sample size At least 8 µLInteractions Refer to test stri

CoaguChek XS Plus Meter Limited (1 Year) WarrantyROCHE DIAGNOSTICS warrants, to the original purchaser only, that the meter shall be free from all def

0123 COAGUCHEK is a trademark of Roche. Manufactured for: Roche Diagnostics 9115 Hague Road Indianapolis, IN 46256 Roche Diagnostics GmbH Sand

Quality controlThe CoaguChek XS Plus System has a number of built-in quality-control functions.n A check of the electronic components and functions e

Manual formatThe layout of this operator’s manual has been specially designed to help you locate the most important information quickly and easily. Al

Example 2: This column contains an illustration of the This column contains information linked to display screen. the display screen. The main m

The CoaguChek XS Plus meterThe CoaguChek XS Plus meter14ABCEFJFHIGD

Meter elements overview A Touch screen Shows results, information, symbols and results recalled from memory. To select any of the screen prompts,

Power supplyThe CoaguChek XS Plus meter can operate with either the power adapter provided, batteries, or a special rechargeable battery pack (REF 048

Before using the meter for the first time, carry out the following steps:1 Insert batteries* and/or connect the power adapter.2 Set the current date a

Inserting the batteriesOperating the instrument181 With the meter turned off, press the battery compartment cover release tab and slide the cover o

Meter setup You can call up any displayed function by touching the screen prompt for it with your finger (or a special pen for this purpose). Tou

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Meter setup20Display field and symbolsThe screen prompts that appear during normal operation are shown here, along with their meaning. Error messages

Meter setup21Symbol Meaning180 SECApply blood sample (the time left to apply sample is counted down in the display)180 SECApply QC sample (the time le

22Meter setupSymbol MeaningBattery status: • When the batteries still have their full charge, all segments are lit.• Individual segments disappear

Meter setup23Settings summaryThe diagram below shows all of the SETUP areas that can be accessed on the meter.SetupScreenLanguageUnitsContrast Date/Ti

Meter setup24 Group Subgroup Setting Values * SCREEN CONTRAST 0 - 10 (5 *) RESULT UNITS INR * INR/SEC INR/%Q LANGUAGE Dansk

Meter setup25 Group Subgroup Setting Values * OPTIONS SORT DATE/TIME * PATIENT ID NUMBER BEEPER BEEPER OFF LOW MEDIUM *

Meter setup26 Group Subgroup Setting Values * ID SETUP Admin. (Administrator) Blank (off) * OPERATOR (Operator list is optional) Blank (off) *

Meter setup27Conventions used in this manualThis manual refers to all the various operations of the meter. When discussing a particular operation, a p

Screen setupThe Screen setup area contains the options for changing the way the display looks. ContrastUse this setup option to make the screen displa

Meter setup29UnitsUse this setting to select the unit(s) of measure to be displayed with the results.1 From the main menu screen, touch Setup.2 Fr

Revisions to this document are provided by Roche Diagnostics when necessary. No part of this document may be reproduced in any form or by any means

Meter setup30Language SelectionUse this setting to select the language for all displays (that contain text).1 Touch Setup in the main menu.2 From

Meter setup314 Touch or to scroll to the language of choice on the screen. If the arrow is just an outline , this means the arrow is not active

Meter setup32Setting the dateWhen you turn on the meter for the first time (or after a long period without power), the input field for the date automa

Meter setup33Setting the timeWhen you turn on the meter for the first time (or after a long period without power), the Setup menu appears automaticall

Meter setup34Setting the display options for date and timeYou don’t have to select display options for date and time, even though you must enter the

Meter setup35Options setupSortSort refers to the order in which measured and stored results are displayed when you use your CoaguChek XS Plus meter’s

BeeperNote: Your CoaguChek XS Plus meter can display information visually and alert you to special circumstances with a beeper. When the beeper is act

Meter setup374 Touch the screen prompt with the desired setting for the beeper, then touch the prompt with the setting of choice for the key click.

Meter setup38Auto offYou can set up your CoaguChek XS Plus meter so that it turns itself off automatically if it has not been used (no buttons pressed

Meter setup39ComputerYour CoaguChek XS Plus meter can connect with a computer via an infrared interface using optional base unit. Using a computer, yo

The CoaguChek XS Plus SystemThe CoaguChek XS Plus System is used to monitor coagulation (blood-clotting) values (prothrombin time, PT, Quick value) wi

ID SetupUse the ID Setup screen to enter settings for user management and patient management. These settings are optional; the meter can be operated w

Meter setup41System Administrator (Admin.)In the default setting, the meter is not protected with an Admin. password, and all setup options are access

Meter setup424 Using the keypad displayed on the screen, enter the Admin. password of choice. The password should include up to 20 characters and/or

Meter setup431 From the main menu screen, touch Setup.2 From the Setup menu screen, touch ID Setup.3 Using the keypad displayed on the screen,

Meter setup441 From the main menu screen, touch Setup.2 From the Setup menu screen, touch ID Setup.3 Using the keypad displayed on the screen,

Operator (only available with optional software)To specify operators, an operator list must be created on the PC and downloaded into the meter using s

PatientIn the default setting, input of Patient ID is “optional.” This means a Patient ID can be entered for each test, but this isn’t required. If yo

Meter setup476 Select the input format of the Patient ID to be entered.7 Touch the screen prompt with the format of choice for the Patient ID. You

Lockouts setupNote: The Lockouts menu contains the options for liquid quality control that require the operator to perform a liquid quality control te

Operator lockout (only available with optional software)To perform a test with the CoaguChek XS Plus meter, the individual steps must be performed pro

Introduction ...7 The CoaguChe

Meter setup505 Touch or to display the option of choice on the screen. If the arrow is just an outline , this means the button is not active.6

QC (Quality control) lockoutQC Lockout ensures that the optional liquid quality control tests are run on a regular basis for the meter to be used. Thi

Meter setup525 Touch the screen prompt with your option of choice for changing the test strip lot.6 Touch the screen prompt to select the interval

Gather what you need:n CoaguChek XS Plus metern CoaguChek XS PT Test Strips and matching code chipn CoaguChek Lancetn CoaguChek Capillary tube/bulb

Getting a good capillary blood sampleTo get a suitable drop of blood:n Warm the hand. Have the patient hold it under his or her arm, use a hand warme

Preparing to testTesting a capillary blood sample551 Have the test strip container at hand.2 Make sure that the code chip supplied with these test

Test strip code chipThe test strip code chip provides the meter with important information that it needs to perform the coagulation test. The chip con

Always compare the code number you see on the display with the number that is printed on the test strip container you are using. If the two code numbe

Switching on the meterWithout operator listTesting a capillary blood sample581 Place the meter on a level, vibration-free surface, or hold it in you

With operator list (only available with optional software)Testing a capillary blood sample593 If an operator list exists, wait until this list is di

Testing a capillary blood sample ... 53 Important notes ...

Testing a capillary blood sample60Performing a test8 Check the battery level. If there are no bars left in the battery symbol, you cannot perform an

Without patient listTesting a capillary blood sample6110 Touch Patient Test.11 If the Patient ID option was chosen as either optional or required wh

With patient list (only available with optional software)Testing the capillary blood sample6212 Touch Patient Test.13 Select the patient to be teste

Testing a capillary blood sample6315 The test strip symbol prompts you to insert a test strip. Remove a test strip from its container and close the c

Testing a capillary blood sample64Test09:15 am09/16/2009P-ID: PID01Code: 184Smith, HenryOp: Operator 1Par: PTThe hourglass symbol shows that the test

Testing a capillary blood sample6518 Now lance the side of a fingertip with the lancing device.19 Apply the blood directly from the finger to the se

Testing the capillary blood sample66Test09:15 am09/16/2009P-ID: PID01Code: 184Smith, HenryOp: Operator 1Par: PTDo not add more blood. Do not touch the

Testing a capillary blood sample67Test09:15 am09/16/2009P-ID: PID01Code: 184Smith, HenryOp: Operator 1Par: PTQCTest09:15 am09/16/2009P-ID: PID01Code:1

Testing a capillary blood sample68Remove09:15 am09/16/200920 After the test and results are displayed, a Remove menu will appear on the screen. Remov

The CoaguChek XS Plus System has a number of built-in quality-control functions.n A check of the electronic components and functions every time the m

The CoaguChek XS Plus SystemThe CoaguChek XS Plus System measures blood-clotting time (prothrombin time) for people who are taking anticoagulation me

Preparing to run a liquid quality control testPrepare for a liquid quality control test in the same way you would prepare to perform a test with a ca

Quality control717 Close the container again.8 Make sure the dropper is at hand for the next steps in the liquid quality control test.9 Swirl th

Performing a liquid quality control testQuality control7210 Place the meter on a level, vibration-free surface, or hold it in your hand so it is roug

Quality control7315 Touch Control Test.16 The test strip symbol prompts you to insert a test strip. Remove a test strip from its container and close

Quality control74QC Test09:15 am09/16/2009184Op: Operator 1QC Test09:15 am09/16/2009QC 248QC 379QC 462NewQC 332*QC Test09:15 am09/16/2009Code: 184Op:

Quality control75QC Test09:15 am09/16/2009QC: 999Code: 184Op: Operator 1Par: PTLevel 1Level 2QC Test09:15 am09/16/2009QC: 999Code: 184Op: Operator 1Pa

Quality control7621 Using the dropper, draw up the dissolved contents of the vial. 22 Apply a single drop of control solution directly from the drop

Quality control77QC Test09:15 am09/16/2009QC: 999Code: 184Op: Operator 1Par: PTLevel: 1QC Test09:15 am09/16/20091.2 INR09/16/2009 09:15 amQC: 999Code:

If a liquid quality control test fails, an up arrow (too high) or down arrow (too low) is displayed and flashes.In this display, you can scroll throug

The CoaguChek XS Plus meter has a 1,000-value memory for saving results (patient tests and/or liquid quality control tests) together with time and dat

Test principleThe CoaguChek XS PT Test, used as directed with the CoaguChek XS Plus Meter, will provide an electrochemical measurement of prothrombin

Review Results80Memory09:15 am09/16/2009QC ResultPatient Result4 Select the function you want to perform in the memory.The following symbols for gen

Display Patient Result memoryReview Results811 Touch or to display the entry of choice on the screen. If the arrow is just an outline , this mea

Display QC (Quality Control) memoryReview Results82Memory09:15 am09/16/2009PID0109/14/2009 10:10 amPID0109/13/2009 10:07 amPID0109/12/2009 10:01 amPID

It is important to follow the procedures below to clean and disinfect the meter. Failure to follow these procedures may cause malfunction of the meter

Cleaning/Disinfecting the Test Strip Guiden Use only 70% isopropyl alcohol or 10% bleach solution to clean/disinfect the CoaguChek Plus test strip gu

Cleaning853 Allow to dry With the cover off, allow the test strip guide to dry for about 10 minutes.4 Close the cover Close the cover, and make sure

Depending on the circumstances, an error message may appear on the display of your meter.Error messages can have up to three warning levels as indicat

Error messages87Error message (always prefaced by Error)Brief descriptionErrorTest strip guide cover openErrorJVKLCode chip errorErrorEXPTest strip be

Error messages88Error message (always prefaced by Error)Brief descriptionErrorQCQuality control: Test strip unusable or quality control for new lot mi

Error messages89Error message (always prefaced by Error)Brief descriptionErrorData transfer errorErrorEXPControl solution beyond expiration dateErrorM

Safety InformationThe CoaguChek XS Plus System9Protection against infectionMedical staff using the CoaguChek XS Plus System to perform tests on patien

Error messages90Error Description/SolutionError: Test stripA test strip was already inserted when the meter was turned on with the ON/OFF button.Error

Error messages91Error Description/SolutionError: CoverThe test strip guide cover is not properly closed.ErrorSolutionClose the test strip guide cover.

Error messages92Error Description/SolutionError: Time for application exceededThe maximum allowed time of 180 seconds for applying blood has been exce

Error messages93Error Description/SolutionError: Quality ControlThis message appears if quality control lockout was set up for NEW CODE lockout.A qual

Error messages94Error Description/SolutionError: Diagnostic testError during the internal diagnostic test which the meter performs.Error8SolutionTurn

Error messages95Error Description/SolutionError: Memory test (setup)The memory contains faulty data.ErrorSolutionThe meter has a fault. Please call Ro

96Error messagesError Description/SolutionError: Date/time settingDate/time is inconsistentErrorDD:MM:YY?SolutionCheck date/time.Error: PasswordThe en

97OrderingPlease contact Roche Diagnostics Customer Service at 1-800-428-5076.CoaguChek XS PT Test, 2 x 24 test strips REF 04625315160CoaguChek XS Pl

PreambleThe licenses for most software are designed to take away your freedom to share and change it. By contrast, the GNU General Public License is i

Further information99translated into another language. (Hereinafter, translation is included without limitation in the term “modification”.) Each lice