P O I N T O F T E S T I N G C A R E CoaguChek XS Pro ® Operator’s Manual
Revision History Manual version Revision date Changes Version 1.0 2009-09 New document Version 2.0 2010-04 Update cleaning/disinfection, minor revisions Version 3.0 2010-10 Update to SW 03 Version 4.0 2012-04 Update to SW 03.
CoaguChek XS Pro ® Operator’s Manual 0 5548829001 (03) 2012-04 EN
© 2012 Roche Diagnostics GmbH. All rights reserved The contents of this document, including all graphics, are the property of Roche Diagnostics. Information in this document is subject to change without notice. Roche Diagnostics shall not be liable for technical or editorial errors or omissions contained herein. No part of this document may be reproduced or transmitted in any form or by any means, electronic or mechanical, for any purpose, without the express written permission of Roche Diagnostics.
1 Introduction 9 Before you start........................................................................................................................................... 9 Intended use ........................................................................................................................................ 9 Field of application ............................................................................................................................
ID setup........................................................................................................................................................ 56 System Administrator (Admin.)................................................................................................... 58 Operator ID ........................................................................................................................................ 64 Patient ID .....................................................
10 Troubleshooting 127 Additional information on error E-406 .................................................................................. 128 Errors and unusual behavior without error messages .................................................... 129 11 General Product Specifications Technical data ........................................................................................................................................ Sample material ......................................................
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Introduction 1 Introduction Before you start Intended use The CoaguChek® XS Pro system (CoaguChek XS Pro meter and CoaguChek XS PT Test strips) quantitatively determines prothrombin time (“PT”), using capillary blood or whole blood from a vein (nonanticoagulated venous whole blood). It is indicated for use by healthcare professionals. The system is ideally suited to monitor coagulation values in people who are taking oral anticoagulation medication (vitamin K antagonists, VKAs).
Introduction If you need help Information about using the system, the screen menus, and performing a test can be found in this manual. When error messages appear on the screen, refer to chapter 10 Troubleshooting. For all questions about the CoaguChek XS Pro system that are not answered in this manual, contact your Roche representative. In order to expedite troubleshooting, please have ready your CoaguChek XS Pro meter, its serial number, this manual, and all related consumables when you call.
Introduction The meter guides you through the test, step by step, using icons and instructions on the display. Each box of test strips has its own code chip that you insert into the meter. This code chip contains lot-specific information about its test strips, such as the expiration date and calibration data. Optional liquid controls for the system are also available.
Introduction Important safety instructions and additional information This section explains how safety-related messages and information related to the proper handling of the system are presented in the CoaguChek XS Pro Operator’s Manual. Read these passages carefully. The safety alert symbol alone (without a signal word) promotes awareness to hazards which are generic or directs the reader to related safety information.
Introduction Illustrations in this manual show two different kinds of hands: Hand without glove Hand with glove A dashed arrow between screen illustrations indicates that some screens have been skipped in these illustrations.
Introduction Safety Information Operator qualification Only trained healthcare professionals may operate the CoaguChek XS Pro system. Operators must have received comprehensive instruction in the operation, quality control, and care of the CoaguChek XS Pro system. WARNING 14 Protection against infection There is a potential risk of infection. Healthcare professionals using the CoaguChek XS Pro system must be aware that any object coming into contact with human blood is a potential source of infection.
Introduction Disposal of the System WARNING Infection by a potentially biohazardous instrument The CoaguChek XS Pro system or its components must be treated as potentially biohazardous waste. Decontamination (i.e., a combination of processes including cleaning, disinfection and/or sterilization) is required before reuse, recycling, or disposal. Dispose of the system or its components according to the appropriate local regulations.
Introduction General Care NOTICE Clean the meter only with the solutions recommended (see page 123). Using other solutions may result in incorrect operation and possible system failure. Do not let cleaning solution enter the instrument. Make sure that the meter is thoroughly dried after cleaning or disinfecting. Laser Scanner The built-in barcode scanner emits a laser beam when activated. The built-in barcode scanner is a Class 1 laser, according to EN 60825-1:2007.
Introduction Operating conditions To ensure that the meter functions properly, please observe the following guidelines: ■ Only use the meter at a room temperature between 15 °C and 32 °C (59 °F and 90 °F). ■ Only use the meter at a relative humidity between 10% and 85% (no condensation). ■ When operating the meter using the power adapter, use only a voltage of 100 V to 240 V (± 10%) , 50/60 Hz. ■ When testing, place the meter on a level, vibration-free surface, or hold it so it is roughly horizontal.
The CoaguChek XS Pro Meter 2 The CoaguChek XS Pro Meter A B C F E D G H 18 I J K L
The CoaguChek XS Pro Meter Overview of the meter elements A Touchscreen Shows test results, information, icons, and results recalled from memory. To select an option, simply touch the button lightly. B On/Off button Press and hold this button to power the meter on or off. C Test strip guide cover Remove this cover to clean the test strip guide (if it has become soiled, e.g., with blood). D Test strip guide Insert the test strip here.
The CoaguChek XS Pro Meter Buttons and icons overview The buttons and icons that appear during normal operation are shown here, along with their respective meanings. Error messages and the description of the icons linked to them are provided in a separate chapter. See Troubleshooting starting on page 127. Button/Icon Meaning Go to Main Menu OK; save setting Cancel; discard setting Return (to previous menu) Reduce/increase the value displayed.
The CoaguChek XS Pro Meter Button/Icon 180 SEC QC QC %Q Sec INR Meaning Apply liquid control (QC) sample (the time left to apply sample is counted down in the display) Insert the test strip code chip Insert the QC code chip Automatic quality control completed successfully Results are displayed as a Quick percentage value Results are displayed in seconds Results are displayed in INR units Result in the chosen unit of measure is above the measuring range.
The CoaguChek XS Pro Meter Button/Icon Meaning The test strip guide cover is open Communication is taking place via the infrared interface Reports a status message (see: Chapter 10 Troubleshooting) Reports an error message or a warning (see: Chapter 10 Troubleshooting) Power supply The CoaguChek XS Pro meter can be operated with either the power adapter provided, four standard type AA alkaline, non-rechargeable batteries, or a special rechargeable battery pack (optional).
The CoaguChek XS Pro Meter Main Menu 09:15 am Patient Test Control Test Review Results Setup During battery operation, the meter always displays the battery power level. When replacing the batteries or the rechargeable battery pack, you must insert the new batteries or battery pack within ten (10) minutes of removing the old one(s) to retain the date and time settings. If you take longer than this, you must re-enter the date and time.
Putting the Meter into Operation 3 Putting the Meter into Operation Before using the meter for the first time, perform the following steps: 1 Insert batteries and/or connect the power adapter 2 Set the current date and time 3 Enter the settings of choice (language, unit of measure, user administration if applicable, etc.) Instead of batteries, you can use a special rechargeable battery pack. If you choose this option, order the pack separately from Roche Diagnostics.
Putting the Meter into Operation Inserting the batteries 1 With the meter powered off, press the battery compartment cover release tab and slide the cover off. 2 Insert the four batteries in the battery compartment as indicated. The batteries should last about 80 tests, depending on the type of battery used.
Putting the Meter into Operation 3 Slide the battery compartment back onto the meter and close it. The meter powers itself on after the batteries have been inserted. Powering the meter on and off 1 Place the meter on a level, vibration-free surface, or hold it in your hand so it is roughly horizontal. 2 Power the meter on by pressing the button for approximately 1 second. You can also power on the meter directly by inserting a test strip or connecting the power adapter.
Putting the Meter into Operation Checking the software version Init CoaguChek XS Pro 03.01.00 After displaying the Roche logo, the meter briefly displays the Init (for “initialization” ) screen. Here you can check which software version is currently running on your meter. (The Init screen shown here is for illustration purposes only. Version numbers on your meter may differ.
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Meter Setup 4 Meter Setup Note on presentation of screen elements in this manual Buttons are screen prompts that cause something to happen when touched. The names of all buttons are either shown as bold text or as the icon used on the button (e.g., for OK ). Other screen elements (e.g., Menu titles) are written in italics. These screen elements are not active.
Meter Setup Settings summary The diagram below shows all of the setup areas that can be accessed on the meter. Setup Screen Result Confirmation Contrast Result Units Language Selection Date / Time Options Sort Beeper Auto Off Connection ID Setup Admin. Operator Patient QC Settings QC Range 30 QC Lockout Operator Lockout STAT Test Config.
Meter Setup Group Screen Subgroup Setting Values * Contrast 0 – 10 (5 *) Result Units INR * INR/SEC INR/%Q Result Confirmation Enable Disable * Language Selection Dansk Deutsch English * Español Français Italiano Nederlands Norsk Português Suomi Svenska Date/Time Date 01/01/2012 * Time 12:00 am * Date formats DD.MM.YYYY (01.01.
Meter Setup Group Options Subgroup Setting Sort Values * Date/Time * Patient ID Patient Name Beeper Beeper Off Low Medium * High Key Click Off * On Auto Off [minutes] Off 1 … (5*) … 10 15 20 25 30 40 50 60 Connection Off * Computer Printer * Default settings are labeled with an asterisk (*).
Meter Setup Group ID Setup Subgroup Setting Values * Admin.
Meter Setup Screen setup The Screen setup area contains the options for changing the display. Contrast Use the Contrast menu to adjust the display to your ambient light conditions and make it easier to read. Main Menu 09:15 am Patient Test Control Test 1 From the Main Menu, touch Setup to open the meter settings. 2 From the Setup Menu, touch Screen. 3 From the Screen menu, touch Contrast.
Meter Setup Contrast 09:15 am Contrast (0-10): 5 4 Touch or to change the contrast in a range from 0 to 10. ■ Contrast “0” makes the display very dark. ■ Contrast “10” makes the display very light. 5 Touch to save this setting, or touch to exit this menu without saving any changes. The display automatically returns to the previous screen. 04/19/2012 Result Units Use this setting to select the unit(s) of measure to be displayed with the results.
Meter Setup The current unit of measure setting is highlighted (white type on a blue background). You can select either: Units 09:15 am ■ INR ■ INR and seconds ■ INR and Quick value in % 4 Touch the button to select the unit of measure of choice. Your selection is now highlighted. 5 Touch INR INR/SEC INR/%Q 04/19/2012 36 to save this setting, or touch to exit this menu without saving any changes. The display automatically returns to the previous screen.
Meter Setup Result Confirmation In some circumstances, it may be useful for operators to confirm the validity of their results. Use this setting to prompt operators to confirm the results of every test. Main Menu 09:15 am Patient Test Control Test 1 From the Main Menu, touch Setup to open the meter settings. 2 From the Setup Menu, touch Screen. 3 From the Screen menu, touch Result Confirmation. 4 Touch Enable or Disable. Your selection is now highlighted.
Meter Setup Language Selection Use this setting to select the language for all displays (that contain text). Main Menu 09:15 am Patient Test Control Test 1 From the Main Menu, touch Setup to open the meter settings. 2 From the Setup Menu, touch Screen. 3 From the Screen menu, touch Language Selection. Review Results Setup 04/19/2012 Setup Menu The current language setting is highlighted (white type on a blue background).
Meter Setup Setting the date When you power on the meter for the first time (or after a long period without power), the input field for the date automatically appears first. The date (and time) must be entered before the meter can be used further. If at a later time a date adjustment is needed, go to the Setup menu, then select the menu of choice. Both Date and Time display formats are controlled by the Format options you select (see page 43).
Meter Setup Date/Time 09:15 am 4 From the Date/Time menu, touch Set Date. 5 Touch and to set the year, then the month, then the day. 6 Touch Set Date Date Set Time Year: 09:15 am 2012 Format 04/19/2012 Month: 1 Day: 1 touch to exit this menu without saving any changes. The display automatically returns to the previous screen. 04/19/2012 If this setup menu appeared automatically after powering the meter on, you must touch to complete the first date setting.
Meter Setup Setting the time When you power on the meter for the first time (or after a long period without power), this Setup menu appears automatically after you set the date. If at a later time a time adjustment is needed, go to the Setup menu, then select the menu of choice. Main Menu 09:15 am Patient Test Control Test 1 From the Main Menu, touch Setup to open the meter settings. 2 From the Setup Menu, touch Screen. 3 From the Screen menu, touch Date/Time.
Meter Setup Date/Time 09:15 am 4 From the Date/Time menu, touch Set Time. 5 Touch and the minutes. 6 Touch Set Date Time Set Time Hour: 09:15 am 9 Format Minute: 59 AM 04/19/2012 to save this setting, or touch to exit this menu without saving any changes. The display automatically returns to the previous screen. PM 04/19/2012 If this setup menu appeared automatically after powering the meter on, you must touch to complete the first time setting.
Meter Setup Setting the display options for date and time Select your preferred format for the date and time display. Main Menu 09:15 am Patient Test Control Test 1 From the Main Menu, touch Setup to open the meter settings. 2 From the Setup Menu, touch Screen. 3 From the Screen menu, touch Date/Time.
Meter Setup Date/Time 4 09:15 am Set Date Format Set Time Date: Format 09:15 am DD.MM.YYYY MM/DD/YYYY YYYY-MM-DD 04/19/2012 Time: 04/19/2012 24H 12H From the Date/Time menu screen, touch Format. The current settings are highlighted. You can select one of the following display formats: ■ Date: DD.MM.YYYY (Day.Month.Year), e.g., 30.09.2012 ■ Date: MM/DD/YYYY (Month/Day/Year), e.g., 09/30/2012 ■ Date: YYYY-MM-DD (Year-Month-Day), e.g.
Meter Setup Options setup Sort Sort refers to the order in which measured and stored results are displayed when you use the Review Results function of the CoaguChek XS Pro meter. You can display stored results chronologically by date and time or by person, based on the Patient ID. If you are working with a DMS and a patient list, you can also display the patient list and the stored results sorted by Patient Name.
Meter Setup Sort 09:15 am Sort By: The current setting is highlighted. You may select from the following sort options: Date / Time ■ By Date/Time Patient ID ■ By Patient ID ■ By Patient Name 4 Touch the button to select the Sort by option of choice. Your selection is now highlighted. Patient Name 04/19/2012 The sort option Patient Name is available only when used together with a patient list. Patient lists can only be created with a DMS.
Meter Setup Beeper The CoaguChek XS Pro meter can display information visually and alert you to special circumstances with a Beeper.
Meter Setup Main Menu 09:15 am Patient Test Control Test Review Results Setup 04/19/2012 Setup Menu 09:15 am Screen Options ID Setup QC Settings Options 04/19/2012 Sort Beeper Auto Off Connection 04/19/2012 48 09:15 am 1 From the Main Menu, touch Setup to open the meter settings.. 2 From the Setup Menu, touch Options. 3 From the Options menu, touch Beeper.
Meter Setup Beeper 09:15 am The current setting is highlighted. You may select from the following options: Off For the Beeper Low ■ Off Medium ■ Low High ■ Medium ■ High Key Click: 04/19/2012 On Off For the Key Click ■ On ■ Off 4 Touch the button with the desired setting for the Beeper, then touch the button with the setting of choice for the Key Click. Both selections are now highlighted. 5 Touch to save this setting, or touch to exit this menu without saving any changes.
Meter Setup Auto Off You can set up your CoaguChek XS Pro meter so that it powers itself off automatically if it has not been used (no buttons touched or tests run) for a preselected time period. Use this feature to save power and extend the life of the batteries. Main Menu 1 09:15 am Patient Test Control Test From the Main Menu, touch Setup to open the meter settings. 2 From the Setup Menu, touch Options. 3 From the Options menu, touch Auto Off.
Meter Setup You may select from the following options: Auto Off 09:15 am Minutes: ■ Off (meter never powers itself off) ■ Time until meter powers itself off: 1…10, 15, 20, 25, 30, 40, 50, 60 minutes 4 Touch or to select the time of choice in minutes or to switch the feature off. 5 Touch 5 04/19/2012 to save this setting, or touch to exit this menu without saving any changes. The display automatically returns to the previous screen.
Meter Setup Connection In the Connection menu you can configure the data exchange with external devices. The meter can be connected either to a computer or a printer. Main Menu 09:15 am Patient Test Control Test Review Results Setup 04/19/2012 Setup Menu 09:15 am Screen Options ID Setup QC Settings Options 04/19/2012 Sort Beeper Auto Off Connection 04/19/2012 52 09:15 am 1 From the Main Menu, touch Setup to open the meter settings. 2 From the Setup Menu, touch Options.
Meter Setup Computer The CoaguChek XS Pro meter can connect with a computer or host system running appropriate software (that is, a DMS must be installed). To use this connectivity feature, however, you need the optional Handheld Base Unit. The connection is established in two steps. ■ The meter connects to the Handheld Base Unit via infrared. ■ The Handheld Base Unit is either connected to a single computer (via USB) or to a network/host system (via ethernet).
Meter Setup Printer The CoaguChek XS Pro meter can also connect directly to a printer. To use the printing feature you need an optional infrared printer. Main Menu 09:15 am Patient Test Control Test Review Results Setup 04/19/2012 Setup Menu 09:15 am Screen Options ID Setup QC Settings Options 04/19/2012 Sort Beeper Auto Off Connection 04/19/2012 54 09:15 am 1 From the Main Menu, touch Setup to open the meter settings. 2 From the Setup Menu, touch Options.
Meter Setup Connection 09:15 am Off 4 Touch Printer. Your selection is now highlighted. 5 Touch to save this setting, or: Computer Touch to exit this menu without saving any changes. The display automatically returns to the previous screen. Printer 04/19/2012 Memory 09:15 am P-ID: PID01 Smith, Henry Op: Operator 1 Par: PT Code: 184 04/18/2012 11:31 am 2.5INR 21%Q Doctor Notified Sick Travel To print : ■ Align the meter with the IR printer. ■ At any test or memory screen, touch .
Meter Setup ID setup Use the ID Setup menu to enter settings for user management and patient management. These settings are optional and set to Off/Inactive by default; the meter can be operated without these settings. There are three types of identification used with the meter: ■ System Administrator: The Admin. (Administrator) has special rights to enter certain meter settings and is the only one who can enter and change these settings. It is not necessary for Admin.
Meter Setup The buttons in the ID Setup menu show what the current settings are (this is just an example, the screen may look different on your meter): ID Setup 09:15 am ■ The standard display of the Admin. button means the function is available but not activated (a password for the system administrator/supervisor has not been assigned). ■ The standard display of the Operator button means the Operator login is available but not activated.
Meter Setup System Administrator (Admin.) In the default setting, the meter is not protected with an Admin. password, and all setup options are accessible to every user. If you set up an Admin. password, the following setup areas are automatically reserved only for the system administrator/supervisor (i.e., the person who knows the password).
Meter Setup If an Admin. password has not been set up yet: Main Menu 09:15 am Patient Test Control Test 1 From the Main Menu, touch Setup to open the meter settings. 2 From the Setup Menu, touch ID Setup. 3 From the ID Setup menu , touch Admin. Review Results Setup 04/19/2012 Setup Menu 09:15 am Screen Options ID Setup QC Settings ID Setup 04/19/2012 09:15 am Admin.
Meter Setup ***| Admin. 09:15 am Admin. | 09:15 am A B C D E 0 1 2 3 4 F G H I J 5 6 7 8 9 K L M N O P Q R S T U V W X Y Z 123 4 Using the keypad displayed on the screen, enter the Admin. password of choice. The password can consist of up to 20 characters. Pay close attention to the buttons you press, because the characters are not displayed on the screen. Asterisks are displayed instead (as if entering a password on a computer).
Meter Setup Repeat ID 09:15 am ***| A B C D F G H I J K L M N O P Q R S T U V W X Y Z 123 E 9 Enter the Admin. password again (the keypad is automatically displayed again on the screen) to confirm the first entry. 10 Touch to save this entry, (the Admin. password is now set), or Touch to exit this menu, the Admin. password is not set and is therefore still inactive. The display automatically returns to the ID Setup menu.
Meter Setup Changing an existing Admin. password: Main Menu 09:15 am Patient Test Control Test 1 From the Main Menu, touch Setup to open the meter settings. 2 From the Setup Menu, touch ID Setup. 3 Using the keypad displayed on the screen, enter the valid Admin. password. Review Results The ID Setup menu is displayed. The Admin. button is highlighted, which means an Admin. password is active. Setup Setup Menu 04/19/2012 09:15 am Screen Options ID Setup QC Settings 04/19/2012 ***| Admin.
Meter Setup Deactivating an existing Admin. password: Main Menu 09:15 am Patient Test Control Test 1 From the Main Menu, touch Setup to open the meter settings. 2 From the Setup Menu, touch ID Setup. 3 Using the keypad displayed on the screen, enter the valid Admin. password. Review Results The ID Setup menu is displayed. The Admin. button is highlighted, which means an Admin. password is active.
Meter Setup Operator ID If you want to create a list of Operator IDs from which you can select an operator, additional software (a data management system) and the Handheld Base Unit are required (for more details see Data handling, starting on page 119). In the default setting, the Operator login is not activated. You can either activate or deactivate Operator login on the meter. If activated, an Operator has to log in before the Main Menu will be displayed and measurements can be performed.
Meter Setup Patient ID If you want to create a list of Patient IDs from which you can select a patient for testing, additional software (a data management system) and the Handheld Base Unit are required (see page 119). In the default setting, input of Patient IDs is set to No. This means each test is simply assigned a consecutive number. However, you can require that a Patient ID be entered or make it optional.
Meter Setup Patient ID No Optional 09:15 am You may select from the following options: ■ No (tests will be assigned numbers automatically) ■ Optional (automatic numbering or list/scan/manual input) ■ Required (list/scan/manual input) 4 Touch the button with the setting of choice. Your selection is now highlighted. 5 Touch Required 04/19/2012 to save this setting, or touch to exit this menu without saving any changes. The settings for the option No are now completed.
Meter Setup 6 Select the form for input of the Patient ID. You may select from the following options: Patient ID 09:15 am Alphanumeric ■ Alphanumeric Enter any combination of letters and numbers, e.g., “J. DOE 3378” ■ Numeric Enter numbers only, e.g., “3387” ■ Min. Length Enter the minimum number of characters (1 … 20) the Patient ID must have. ■ Max. Length Enter the maximum number of characters (1 … 20) the Patient ID can have.
Meter Setup QC Settings setup The QC Settings menu contains options for enforcing the performance of liquid quality controls by the operator at specified intervals. It also provides the option of customizing the QC Range in accordance with applicable local guidelines. QC Range There are two options: ■ Default Range: The meter displays the QC Range provided by Roche in the code chip. ■ Custom Range: The option Custom Range lets the user define their own QC Range within the default range.
Meter Setup QC Range Liquid Quality control ranges can be customized to comply with local guidelines. The QC Range function enables you to narrow the default range. Main Menu 09:15 am Setup Menu 09:15 am 1 From the Main Menu, touch Setup to open the meter settings. 2 From the Setup Menu, touch QC Settings. 3 From the QC Settings menu, touch QC Range.
Meter Setup QC Range 09:15 am QC Range Display target value 09:15 am On Default Range Custom Range Deviation from target value 11.5 % 04/19/2012 Off If you selected Custom Range, the QC Range screen opens and offers you the following options: ■ Display target value (On/Off) ■ Deviation from target value (percentage value). See page 69. For the control solutions, the target value always comes from the information stored in the code chip.
Meter Setup 6 Use the arrows to to set the allowed percentage deviation from the target value. Use the arrows on the left to adjust the whole number before the decimal point. Use the arrows on the right to adjust the number after the decimal point. 7 Touch to save this setting, or touch to exit this menu without saving any changes. The display automatically returns to the QC Settings screen.
Meter Setup QC (quality control) Lockout The QC Lockout ensures that the optional quality control tests are run on a regular basis. This is independent of the operator, however. This option should be used if you work without operator lists. It is also possible to mandate Operator Lockouts and QC Lockouts in parallel. In addition to defining time intervals, QC Lockout can also be used to specify that a quality control test must be carried out when a new test strip lot is used (New Code).
Meter Setup QC Lockout New Code 09:15 am Yes 4 No No Select the triggers, based on lot and/or time, for requiring a quality control test. You may select from the following options: Daily ■ Weekly Monthly New Code Yes/No (applies every time a new test strip lot is used) The general intervals are: 04/19/2012 ■ No ■ Daily ■ Weekly ■ Monthly 5 Touch the button with the option of choice when changing the test strip lot. 6 Touch the button to select the interval of choice.
Meter Setup Operator Lockout Optional liquid quality controls can be used to ensure that an operator is performing tests properly on the CoaguChek XS Pro meter. The Operator Lockout function constrains an operator, who has been set up in the list, to perform these quality controls on a regular basis.
Meter Setup Op. Lockout 09:15 am 4 No Weekly Select the interval of choice in which the mandatory quality control tests must be performed. Monthly Every 3 Months You may select from the following options: Every 6 Months 04/19/2012 Op. Lockout 09:15 am ■ No (deactivated) ■ Weekly ■ Monthly ■ Every 3 Months or Every 6 Months ■ Yearly 5 Touch and to display the option of choice on the screen. 6 Touch the button to select the interval of choice. Your selection is now highlighted.
Meter Setup Op. Lockout 09:15 am Number of Levels 8 For every option except for No, you must now indicate the number of levels in which the quality control must be performed. 9 Touch One Level Two Levels 04/19/2012 to save this setting, or touch to exit this menu without saving any changes. The display automatically returns to the previous screen. STAT Test Configuration Quality control tests ensure consistent quality and accurate measurements.
Meter Setup Main Menu 09:15 am Patient Test Control Test 1 From the Main Menu, touch Setup to open the meter settings. 2 From the Setup menu, touch QC Settings. 3 From the QC Settings menu, touch STAT Test Config. 4 Touch Enable to allow STAT Tests or touch Disable to prohibit STAT Tests. Your selection is now highlighted. 5 If you have enabled the option, touch and to set the number of additional tests.
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Testing a Blood Sample 5 Testing a Blood Sample What you need: ■ CoaguChek XS Pro meter ■ CoaguChek XS PT Test Strips and matching code chip ■ When testing with capillary blood: – Lancing device approved for professional use (e.g., the Accu-Chek Safe-T-Pro Plus lancing device or the CoaguChek Lancets) – CoaguChek Capillary Tubes/Bulbs (optional) Do not use glass capillary tubes or capillary tubes that contain anticoagulants.
Testing a Blood Sample Never … ■ … store the meter at extreme temperatures (above 40 °C or 104 °F) while it is in regular use. ■ … store the meter in damp or humid conditions without protection. ■ … remove or insert the code chip while the meter is performing a test. ■ … use the code chip from a pack of strips other than the one in use. ■ … touch or remove the test strip during a test. ■ … wait more than 15 seconds after a fingerstick before applying the blood.
Testing a Blood Sample Getting a good capillary blood sample To get a suitable drop of blood: ■ Warm the hand. Have the patient hold it under his or her arm or use a hand warmer. Wash hands with soap and warm water. Dry thoroughly. ■ Have the patient let that arm hang down by his or her side before lancing a finger. ■ Massage the finger from its base. Use these techniques until the fingertip has increased color.
Testing a Blood Sample Preparing to test 1 Have the test strip container at hand. 2 Make sure that the code chip supplied with these test strips is at hand. Each pack of test strips contains a code chip. The number on the code chip and the number on the test strip container must match. A capital S in front of the number indicates that this code chip is for test strips. (A capital C in front of the number indicates that it is a control solution code chip.
Testing a Blood Sample Test strip code chip The code chip provides the meter with important information that it needs to perform the coagulation test. The chip contains information about the test method, the lot number, and the expiration date. The code chip is required, whenever a new test strip lot is used, so that the meter can read and store the lot information about that particular lot of test strips. The CoaguChek XS Pro meter stores the data from up to 60 code chips that have been inserted.
Testing a Blood Sample 2 Check that the number on the code chip matches the number on the label of the test strip container. 3 Slide the new code chip into the code chip slot (as shown) until you feel it snap into place. If the code chip is missing or incorrectly inserted, error messages appear in the display (refer to the Troubleshooting section of this manual).
Testing a Blood Sample Powering on the meter 1 Place the meter on a level, vibration-free surface, or hold it in your hand so it is roughly horizontal. 2 Power the meter on by pressing the button for approximately 1 second. You can also power on the meter directly by inserting a test strip or connecting the power adapter. The next steps depend on whether you work with the function Operator ID set to inactive or active (see Data handling on page 119).
Testing a Blood Sample If the function Operator ID is active: Operator ID | 09:15 am A B C D E F G H I J K L M N O P Q R S T U V W X Y , 123 Z Scan WARNING 86 Without operator list: 3 You are now prompted to enter an Operator ID. ■ Enter the Operator ID using the keypad. Touch to move to the next screen. ■ Alternatively, the Operator ID can also be entered via the built-in barcode scanner. Touch Scan and scan the operator barcode from a distance of approx.
Testing a Blood Sample Operator 09:15 am Alan Smithee Jane Brown Ann Casey With operator list: 3 Wait until the operator list is displayed. 4 Select the operator of choice by touching the corresponding button. 5 Enter the (optional) password. 6 After you enter the password, touch to log on. The Main Menu is displayed and you can start the test. 7 When you touch , the operator pick list is displayed again.
Testing a Blood Sample Performing a test Main Menu 09:15 am Patient Test 1 Check the battery level. ■ If the battery icon turns red (one bar left), there may not be enough power left for another test. ■ If there are no bars left in the battery icon, you cannot perform any more tests. Power the meter off using the button. Control Test Review Results Setup 04/19/2012 In both cases, restore power by inserting new batteries, recharging the battery pack, or using the power adapter.
Testing a Blood Sample Without patient list Patient ID | 09:15 am A B C D F G H I J K L M N O P Q R S T U V W X Y , 123 Z Scan 3 Touch Patient Test. 4 If the Patient ID option was chosen as either Optional or Required when the meter was set up (see Meter Setup/ Patient ID), you are prompted to enter a Patient ID. ■ If Required, enter the Patient ID, then touch to move to the next screen. ■ If Optional, ignore the prompt and touch to move to the next screen.
Testing a Blood Sample With patient list Test 09:15 am PID01 Smith, Henry Patient ID | 09:15 am PID02 Jones, Walther A B C D PID03 Hamilton, Fran F G H I J PID04 Miller, Ted K L M N O P Q R S T U V W X Y , 123 PID05 Reed, William New 04/19/2012 Scan Z 5 Touch Patient Test. 6 Touch and to display the entry of choice. Select the patient to be tested from the list. 7 If the patient is not in the list, touch New to create a new entry. You must now enter a Patient ID.
Testing a Blood Sample Alternatively, the Patient ID can also be entered via the built-in barcode scanner. Touch Scan and scan the patient barcode from a distance of approx. 10 cm (4 inches). The meter beeps once the barcode has been read successfully. The barcode information appears in the patient ID field. The scanner turns off after 10 seconds, if a barcode is not scanned. WARNING A barcode does not need to be present for the laser scanner to become active. Do not stare directly at the laser beam.
Testing a Blood Sample Test 09:15 am 8 P-ID: PID01 Müller, David Op: Schulz Par: PT The test strip icon prompts you to insert a test strip. Remove a test strip from its container and close the container again with the stopper. 04/19/2012 Exposure to external influences (such as humidity) may deteriorate the test strips and may lead to error messages. Therefore, always close the strip container immediately after removing a test strip.
Testing a Blood Sample Test 09:15 am P-ID: PID01 Smith, Henry Op: Operator 1 Par: PT Code: 184 The hourglass icon shows that the test strip is warming up. When the warming-up process is complete, a further beep (provided the beeper is enabled) indicates that you can now apply blood. 04/19/2012 Test 09:15 am P-ID: PID01 Smith, Henry Op: Operator 1 Par: PT Code: 184 180 SEC The blood drop icon flashes to indicate that the meter is ready to perform the test and is waiting for blood to be applied.
Testing a Blood Sample WARNING Use only a lancing device that is approved for use by healthcare professionals, such as the Accu-Chek Safe-T-Pro or Safe-T-Pro Plus lancing devices, or the CoaguChek Lancets (professional-use lancets available only in the United States). Follow the manufacturer’s instructions. 11 Now lance the side of a fingertip with the lancing device. We recommend obtaining the capillary blood from the side of the fingertip as this causes the least pain.
Testing a Blood Sample When applied from above, the blood must cover the entire sample application area. Test 09:15 am P-ID: PID01 Smith, Henry Op: Operator 1 Par: PT Code: 184 You hear a beep tone when you have applied enough blood (provided the Beeper is enabled). The blood drop symbol disappears and the test starts. 04/19/2012 Do not add more blood. Do not touch the test strip until the result is displayed. Failure to comply with the above may lead to error messages.
Testing a Blood Sample Test 09:15 am The meter performs an automatic quality control test on the test strip before it displays the test result. “QC” appears in the display. P-ID: PID01 Smith, Henry Op: Operator 1 Par: PT Code: 184 QC Following a successful outcome of the quality control test, a checkmark appears after “QC.
Testing a Blood Sample Accepting or rejecting a test result Test 09:15 am P-ID: PID01 Smith, Henry Op: Operator 1 Par: PT Code: 184 04/19/2012 09:14 am 2.5INR 21%Q Measurement Result OK? Reject If this function is enabled, you may choose to accept or reject a test result. When the result is displayed, touch ■ Reject or ■ Accept Accept 04/19/2012 Comment Required I-009 If you reject a result, you must enter a comment with an explanation. A comment is required if you reject a result.
Testing a Blood Sample Adding comments You can add up to three comments to a test result. Comments can provide, for example, additional information about the test conditions or the patient. A comment may be up to 20 characters in length. You can open the function for adding comments directly in the results screen. To add comments: If you want to add a comment, do not remove the test strip. Once the strip is removed, the meter automatically returns to Main Menu and a comment can no longer be added.
Testing a Blood Sample Remove 09:15 am After the test result is displayed, touch . You will be prompted to remove the strip. 5 Remove the test strip from the meter. 6 Power the meter off. 7 Clean the meter if necessary (see Chapter 9, Cleaning and Disinfecting the Meter). 04/19/2012 Protection against infection When collecting samples always observe the general precautions and guidelines relating to blood sampling (see page 14).
Testing a Blood Sample STAT tests STAT tests are a limited number of tests that can be performed in emergency situations, see page 76. If the meter is configured to perform STAT tests, you have the option of performing a test by choosing STAT even though a QC Lockout is in place. Main Menu QC! 09:15 am 1 To perform the measurement without performing a quality control test, touch Patient Test: 2 Touch to confirm the number of remaining STAT tests. 3 Perform the test.
Control Testing and Quality Control 6 Control Testing and Quality Control The CoaguChek XS Pro meter has a number of built-in quality control functions. ■ A check of the electronic components and functions every time the meter is powered on. ■ A check of the test strip temperature while a test is in progress. ■ A check of the expiration date and lot information on the test strip carried out by the code chip.
Control Testing and Quality Control Preparing to run a liquid quality control test Prepare for a liquid quality control test in the same way you would prepare to perform a test with a capillary blood sample. The only difference is the use of control solution instead of blood. 1 Have the test strip container at hand. 2 If you are using the test strip lot for the first time, make sure that the code chip that came with these test strips is at hand.
Control Testing and Quality Control 7 Apply gentle pressure to the reservoir to transfer the entire contents of the dropper to the bottle. Make sure that the dropper does not come into contact with the dried control plasma. 8 Close the bottle again. 9 Make sure the dropper is at hand for the next steps in the liquid quality control test. 10 Swirl the bottle using a circular motion to completely dissolve all of the control plasma inside. Do not shake the bottle or turn it on its side.
Control Testing and Quality Control Performing a liquid quality control test 1 Place the meter on a level, vibration-free surface or hold it in your hand so it is roughly horizontal. 2 Power the meter on by pressing the button for approximately 1 second. You can also power on the meter directly by inserting a test strip or connecting the power adapter.
Control Testing and Quality Control Main Menu 09:15 am Patient Test 4 Check the battery level. ■ If the battery icon turns red (one bar left), there may not be enough power left for another test. ■ If there are no bars left in the battery icon, you cannot perform any more tests. Power the meter off using the button. Control Test Review Results Setup 04/19/2012 In both cases, restore power by inserting new batteries, recharging the battery pack, or using the power adapter.
Control Testing and Quality Control QC Test Op: Schulz 04/19/2012 09:15 am Par: 7 The test strip icon prompts you to insert a test strip. Remove a test strip from its container and close the container again with the stopper. 8 Hold the test strip so the lettering with the test name is facing upward. 9 Slide the test strip into the test strip guide in the direction indicated by the arrows. PT Slide the test strip in as far as it will go.
Control Testing and Quality Control QC Test Op: 09:15 am Operator 1 184 04/19/2012 QC Test * 09:15 am New Code QC 070 QC 050 QC 048 04/19/2012 QC Test 09:15 am QC 04/19/2012 As with the test strips, a quality control code chip is also provided with the control solutions. This chip informs the meter about the acceptable ranges of results for that lot of controls. The information on the code chip is retained in the memory so you can use the same control solutions at any time.
Control Testing and Quality Control QC Test QC: 999 Code: 184 Par: Op: Operator 1 09:15 am PT 11 If performing more than one level, select the level for this measurement. Level 1 Level 2 04/19/2012 QC Test 09:15 am QC: 999 Level: 1 Code: 184 Par: PT Op: Operator 1 The hourglass icon shows that the test strip is warming up. When the warming-up process is complete, a further beep (provided the beeper is enabled) indicates that you can now apply the control solution.
Control Testing and Quality Control 12 Using the dropper, draw up the dissolved contents of the bottle. 13 Apply a single drop of control solution directly from the dropper to the semicircular, transparent sample application area on top of the test strip. Do not add more control solution.
Control Testing and Quality Control QC Test 09:15 am QC: 999 Level: 1 Code: 184 Par: PT Op: Operator 1 You hear a beep when you have applied enough control solution (provided the beeper is enabled). The dropper icon disappears and the test starts. 04/19/2012 QC Test 09:15 am QC: 999 Level: 1 Code: 184 Par: PT Op: Operator 1 04/19/2012 09:15 am Pass: 1.2 INR (1.0 - 1.4 INR) 78 %Q (53 - 99 %Q) The result of the liquid quality control test is displayed. It is automatically saved to memory.
Control Testing and Quality Control QC Comment 09:15 am Acceptable Control Cleaned Meter . 15 Select the desired predefined comment(s) from the pick list (if configured) or 16 Touch Custom to enter your own custom comment. Use the keypad (as with login) to enter your comment. A comment may be up to 20 characters in length. Doctor Notified New Control Lot Custom 17 Once you have selected the desired comment(s), touch to return to the results screen.
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Review Results 7 Review Results The CoaguChek XS Pro meter can save 2000 patient test results as well as 500 liquid quality control tests to memory, together with respective time and date. In addition, up to 60 code chip records (contents of test strip code chips and control solution code chips) are stored. If you are using operator and/or patient lists, a maximum of 5000 Operator and 4000 Patient IDs is allowed. If memory is full when you perform a test, the oldest result is automatically deleted.
Review Results Viewing test results 1 Place the meter on a level, vibration-free surface, or hold it in your hand so it is roughly horizontal. 2 Power the meter on by pressing the button for approximately 1 second. To power the meter off after use, press the button for approximately 1 second. Main Menu 09:15 am Patient Test Control Test Review Results Setup 04/19/2012 114 3 Wait until the main menu is displayed.
Review Results Main Menu 09:15 am 4 Touch Review Results. 5 Select the type of results you want to view.
Review Results Display patient result memory This memory area contains all test results for your patients, sorted according to the setting you chose for the option Sort (see page 45). If the Sort option is set to Date/Time, the most recent results are at the top of the list. Memory 09:15 am PID01 04/18/2012 11:31 am PID01 04/17/2012 10:10 am 1 Touch and to scroll to the entry of choice on the screen. 2 Touch the entry you want to open.
Review Results Display QC (quality control) result memory This memory area contains all liquid quality control tests that were run, sorted chronologically. The most recent results are at the top of the list. QC 09:15 am 04/18/2012 11:31 am QC 999 Pass 04/17/2012 10:05 am QC 234 Pass 1 Touch and to scroll to the entry of choice on the screen. 2 Touch the entry you want to open.
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Extended Functionalities 8 Extended Functionalities Data handling Note: Extended data handling functionality is dependent on the capabilities of the particular Data Management System (DMS) being used and may vary. When used in conjunction with the Handheld Base Unit from Roche (available separately), the CoaguChek XS Pro meter can conveniently connect to a data management system (DMS).
Extended Functionalities Operator lists After powering the meter on, an Operator login may be configured. There are four possible configurations for an Operator login: Operator is activated, but there is no list available: The Operator can either log in via the onscreen keypad or a barcode scan. The use of the meter is not restricted to a predefined Operator group, so Operator IDs are entered via the onscreen keypad or read from the barcode and stored with test results for informational purposes only.
Extended Functionalities Patient lists When starting a Patient Test, there will be the option of either selecting a Patient ID from a patient list, entering the Patient ID using the onscreen keypad or, if available, of scanning the barcode with the Patient ID. The Patient ID, if entered on the DMS, comes with an additional identification entry. Up to 20 characters can be used and assigned as a second confirmation (e.g., name, date of birth).
Extended Functionalities Barcode scanner Using a DMS, the barcode scanner may be configured to accept only selected barcode symbologies (e.g., EAN-13 Barcodes are not allowed). Furthermore it is possible to define a barcode mask for Patient ID and Operator ID. With masks being defined, the meter checks a barcode after scanning and rejects it, if it does not match the mask.
Cleaning and Disinfecting the Meter 9 Cleaning and Disinfecting the Meter NOTICE ■ Observe the disinfection guidelines of your institution. ■ Use gloves. Follow the procedures below to clean/disinfect the meter. Failure to follow these procedures may cause malfunction of the meter. ■ Make sure the meter is powered off. ■ Do not spray anything onto the meter and do not immerse it in liquid. ■ Ensure that cloth or swab/bud is only damp, not wet, to protect against moisture entering the meter.
Cleaning and Disinfecting the Meter Cleaning/disinfecting the exterior (meter housing) Use the solutions recommended on page 123 for cleaning/disinfecting the meter exterior. Apply the solutions for a contact time of > 1 minute (refer to the corresponding product labeling). Ensure that the blue test strip guide cover remains tightly closed while cleaning the meter housing. 1 With the meter powered off, wipe the meter's exterior clean. Do not let liquid accumulate near any opening.
Cleaning and Disinfecting the Meter Cleaning/disinfecting the test strip guide Use the solutions recommended on page 123 for cleaning/disinfecting the test strip guide. Apply the solutions for a contact time of > 1 minute (refer to the corresponding product labeling) using lint-free cotton swabs/buds. 1 Remove the test strip guide cover to clean it. (Use your thumbnail to open the cover of the test strip guide by pressing its front edge upward.) Move the cover safely away from the meter.
Cleaning and Disinfecting the Meter NOTICE Damage to the instrument ■ Ensure that no liquid enters the meter. If moisture enters the meter, it may cause malfunction of the instrument. ■ Do not insert any objects in the test strip guide. Doing so may damage the electrical contacts behind the test strip guide. On completion of cleaning: 3 With the cover off, let the test strip guide dry for at least 10 minutes. 4 After this time, re-attach the test strip guide cover to the housing.
Troubleshooting 10 Troubleshooting The CoaguChek XS Pro meter continually checks its systems for unexpected and unwanted conditions. These may arise for technical reasons (defective components or consumables, environmental factors) or due to handling and procedure errors. Depending on the circumstances, a message may appear on the display of the meter. These messages are marked with an icon, either for a status message, or for an error message.
Troubleshooting E-406: Sample Error Sample Error E-406 Unsuitable sample composition. Check your procedure and repeat the test with a fresh sample. Check medication regimen of patient. Error message Touch to exit this message. Perform the suggested step(s) to solve the problem. Additional information on error E-406 Power the meter off and remove the test strip. Repeat the measurement using a new test strip and blood taken from a new puncture site at the tip of another finger.
Troubleshooting Errors and unusual behavior without error messages Some conditions may arise that have no associated error or status message. Message Description No message or unusual behavior Wait 10 seconds and try powering on the unit again. Meter display does not power on ■ Meter displays an unexpected result Refer to the package insert for the test strips. ■ Check that the meter has power.
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General Product Specifications 11 General Product Specifications Technical data Temperature range +15 °C to +32 °C (59 °F to 90 °F) Relative humidity 10 to 85% (no condensation) Maximum altitude 4300 m (14,000 feet) Position Place the meter on a level, vibration-free surface or hold it so it is roughly horizontal. Measuring range %Q: 120 – 5 SEC: 9.6 – 96 INR: 0.8 – 8.
General Product Specifications Storage and transport conditions Temperature range Meter (without batteries) –25 °C to +70 °C (-13 °F to +158 °F) Temperature range Meter (with batteries)* –10 °C to +50 °C (+14 °F to +122 °F) Relative humidity 10 to 85 % (no condensation) * At temperatures above +50 °C/122 °F the batteries could leak and damage the meter. At temperatures below -10 °C/+14 °F the batteries do not have enough power to keep the internal clock functioning.
General Product Specifications Information about software licenses This product incorporates software modules developed under open source licenses. The source code of this software can be requested on a standard data exchange medium from the manufacturer at the following address: Roche Diagnostics GmbH Sandhofer Str. 116 68305 Mannheim, Germany The General Public License (GPL) licensing conditions are available (in English only for legal reasons) as a PDF file (file name “License.txt.
Warranty 12 Warranty The statutory guarantee provisions on rights in consumer goods sales in the country of purchase shall apply.
Appendix 13 Appendix Contact Roche Argentina Productos Roche S.A.Q. e I. Rawson 3150 B1610BAL Ricardo Rojas, Tigre Buenos Aires - Argentina Tel.: +54 (11) 5129 8000 Australia Roche Diagnostics Australia Pty Ltd. ABN 29 003 001 205 31 Victoria Ave Castle Hill, NSW, 2154 Telephone 02-9860 2222 or 1800 645 619 Austria Roche Diagnostics GmbH Engelhorngasse 3 1211 Wien Telefon: 01 - 27787-0 Fax: 01 - 27787-12 www.coaguchek.
Appendix Chile Productos Roche Ltda. Avda. Quilín 3750 Macul, Santiago Tel.: +56 (2) 4413200 China Roche Diagnostics (Shanghai) Ltd 12/F, Huaihai Plaza, No. 1045, central Huaihai Road Shanghai, 200031 Tel. +86 21 2412 1000 Fax +86 21 2412 1188 PC 200031 Roche Diagnostics (Hong Kong) Ltd 1316-1325 Metroplaza, Tower 1 223 Hing Fong Road, Kwai Chung Hong Kong Tel.: +852-2481 3387 Colombia Productos Roche S.A. Carrerra. 44 No. 20-21 Apartado Aéreo 80372 Bogotá, D.C.
Appendix Ecuador Roche Ecuador S.A. Av. 10 de Agosto N36-239 y Naciones Unidas Quito Tel.:+593 (2) 2434347 Finland Roche Diagnostics Oy PL 160 02180 ESPOO Puhelinvaihde: 010 554511 Suomi France Roche Diagnostics France 2, Avenue du Vercors - BP 59 38242 MEYLAN CEDEX Assistance Téléphonique Tel : +33 4 76 76 31 00 www.rochediagnostics.fr Germany Roche Diagnostics Deutschland GmbH CoaguChek Kundenservice Sandhofer Str. 116 68305 Mannheim Telefon: 0800 0800 855 (gebührenfrei) Montag bis Freitag: 08.
Appendix Indonesia PT. Roche Indonesia Diagnostics Division Artha Graha Building 21st floor Sudirman Central Business District – Lot 25 Jl. Jend. Sudirman Kav. 52-53 Jakarta 12190 Tel.: +62 21 3041 3000 Italy Roche Diagnostics Italia Roche Professional Laboratory HOSPOC Solution Via G.B. Stucchi, 110 20052 Monza (MI) Numero verde: 800-610 619 Korea Roche Diagnostics Korea Co., Ltd. 4F, Seokyung Bldg.
Appendix Netherlands Roche Diagnostics Nederland BV Transistorstraat 41 1322 CK Almere Telefoon: 0800 - 2882882 (gratis) New Zealand Roche Diagnostics N.Z. Ltd 15 Rakino Way, Box 62-089 Mt. Wellington, Auckland Telephone +64 9 276 4157 Toll Free 0800 652 634 Norway Roche Diagnostics Norge AS Brynsengfaret 6B Pb 6610 Etterstad 0607 Oslo Tlf.: +47-23 37 33 00 Fax: +47-23 37 33 99 www.roche.
Appendix Portugal Roche Sistemas de Diagnósticos, Lda. Estrada Nacional, 249-1 2720-413 Amadora Telefone: +351 21 425 7000 www.roche.pt Russia ООО «Рош Диагностика Рус» Официальный дистрибьютор «Ф. Хоффманн Ля Рош Лтд.» (Швейцария) Россия, 107031 Москва Трубная площадь, дом 2 Бизнес центр «Неглинная Плаза» Тел.: +7(495) 229-69-99, +7(495) 229-29-99 Факс: +7 (495) 229-79-99 www.roche.
Appendix Taiwan Roche Diagnostics Ltd. 11F, No. 35, Min Quan E. Road, Section 3 Taipei 104, Taiwan Tel: +886 0800 258 458 Thailand Roche Diagnostics (Thailand) Ltd 18th Floor, Rasa Tower 1 555 Phaholpothin Road, Chatuchak Chatuchak, Bangkok 109000 Tel +66(0) 2791 2200 Turkey Roche Diagnostik Sistemleri Ticaret A.Ş. Gazeteciler Sitesi – Matbuat Sokak No. 3 34394 Esentepe – Istanbul Tel.: +90-212-306 06 06 United Kingdom Roche Diagnostics Ltd.
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Supplement for Observed Test Sequence 14 Supplement for Observed Test Sequence Observed Test Sequence (OTS) The Observed Test Sequence (OTS) function allows an observer (supervisor) to assess and record an operator’s performance (e.g., for recertification purposes). The observer monitors an operator during a test to check that the test is being performed according to the recommended procedures. He/she then evaluates the performance and passes or fails the operator.
Supplement for Observed Test Sequence Using the OTS function A request for an Observed Test Sequence comes from the DMS. The presence of the on the Patient Test button indicates a pending OTS request. Main Menu Observer: 09:15 am 1 Patient Test Review Results Setup Pat. Test - OTS Logout 09:15 am OTS enabled 2 Touch Observer Login. 3 Wait until the observer list is displayed.
Supplement for Observed Test Sequence Pat. Test - OTS 09:15 am Remove 09:15 am Operator: 1 OTS enabled Perform the patient test as usual. Once the test is completed, the observer has to complete the next steps. Observer Login Patient Test 2 04/19/2012 Observer Login I-010 Observer ALAN SMITHEE, please log in to proceed. Otherwise the OTS test will not be complete. Touch Patient Test.
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Index Index A Adapter (power supply) ...........................................................................................................................................22 Admin. password ............................................................................................................................................... 58–63 Applying a blood sample ........................................................................................................................................
Index Display Icons ................................................................................................................................................................ 20–21 Display format ............................................................................................................................................................ 43 Disposal ..........................................................................................................................................
Index Memory Button .................................................................................................................................................................. 115 Patient Result ................................................................................................................................................... 116 Quality Control ..............................................................................................................................................
Index R Relative humidity ..............................................................................................................................................17, 131 Reset button ................................................................................................................................................................ 19 Result confirmation ...........................................................................................................................................
Index Symbols Error messages ................................................................................................................................................ 127 System Administrator ....................................................................................................................................... 58–63 T Target value ............................................................................................................................................................
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Notes Notes 153
Notes Notes 154
Roche Diagnostics GmbH Sandhofer Strasse 116 68305 Mannheim, Germany www.roche.com www.coaguchek.com www.poc.roche.com 0 5548829001 (03) 2012-04 EN ACCU-CHEK, COAGUCHEK and SAFE-T-PRO are trademarks of Roche.
