CoaguChek® Pro II Operator’s Manual
Revision History Manual version Revision date Changes Version 1.0 2015-11 New document Version 2.
CoaguChek® Pro II Operator’s Manual Version 2.
© 2015 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.
On the packaging and on the identification plate of the instrument you may encounter the following symbols, shown here with their meaning: Caution, consult accompanying documents. Refer to safety-related notes in the instructions for use accompanying this product.
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1 Introduction 1.1 Before you start......................................................................................................................................... Intended use ...................................................................................................................................... Important information regarding use ....................................................................................... If you need help ..............................................
3.3 Options setup ........................................................................................................................................... 58 Sort......................................................................................................................................................... 58 Beeper .................................................................................................................................................. 60 Auto Off......................
6 Review Results (Memory) 6.1 Viewing test results .............................................................................................................................. Display patient result memory ................................................................................................. Display QC (quality control) result memory........................................................................ 133 134 136 137 7 Extended Functionalities 7.1 Data handling........................
A Appendix 165 A.1 Operator and patient ID barcode masks........................................................................................165 A.2 Example of barcode symbologies .....................................................................................................166 A.3 Supported characters in 2D barcodes ............................................................................................169 B Appendix 171 B.1 Supplement for Observed Test Sequence ........................
Introduction 1.1 Before you start Intended use The CoaguChek® Pro II system (consisting of the CoaguChek Pro II meter and the CoaguChek family of test strips) is used for the determination of PT and aPTT by healthcare professionals in a Point of Care environment. Important information regarding use Read this operator's manual, as well as the package inserts for all relevant consumables, before using the system for the first time.
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 9, Troubleshooting. For all questions about the CoaguChek Pro II system that are not answered in this manual, contact your Roche Diagnostics representative. In order to expedite troubleshooting, please have ready your CoaguChek Pro II meter, its serial number, this manual, and all related consumables when you call.
INR is a standardized measurement of the rate at which blood clots. A low INR can indicate an increased risk of blood clots, while an elevated INR can indicate increased risk of bleeding. 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.
Contents of the pack The CoaguChek Pro II pack contains the following items: ■ CoaguChek Pro II meter ■ Universal Battery Pack ■ Power supply ■ Operator’s Manual (printed version, not shown here) ■ Manual CD ROM (contains PDF files of the Operator’s Manual in other languages, not shown here) Check for completeness and transport damage immediately after unpacking.
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 Pro II 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.
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.
Safety information Operator qualification Only trained healthcare professionals may operate the CoaguChek Pro II system. Operators must have received comprehensive instruction in the operation, quality control, and care of the CoaguChek Pro II system. WARNING Avoidance of electrical shock, fire, and explosions ■ Only use Roche Diagnostics original accessories (cables, power supply units, battery packs, and spare parts).
Disposal of the system WARNING Infection by a potentially biohazardous instrument The CoaguChek Pro II 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. Always remove the battery pack before thermal disinfection.
Overheating can cause the battery pack to catch fire or explode. ■ Never throw the battery pack or the meters onto a fire. Do not dismantle, compress, or pierce the battery pack as this could cause an internal short circuit that leads to overheating. ■ Do not place either the battery pack or the CoaguChek Pro II meter on or in heating appliances, such as a microwave, conventional oven, or radiator. ■ Avoid prolonged exposure to direct sunlight, e.g.
Observe the following general safety instructions for handling the battery pack: Disposal of used battery packs Do not dispose of the battery pack with normal domestic waste. Dispose of used battery packs in accordance with applicable local regulations and directives and your facility’s guidelines on the disposal of electronic waste equipment. ■ When storing or disposing of the battery pack, use the manufacturer's original packaging.
Touchscreen Local Area Network: protection from unauthorized access Use only your finger (even when wearing gloves) or special pens designed for use with touchscreens to touch the screen elements. Using pointed or sharpedged objects can damage the touchscreen. ■ Avoid prolonged exposure to direct sunlight. Direct sunlight may reduce the life expectancy and functionality of the display. ■ ■ If this meter is connected to a local area network, this network must be protected against unauthorized access.
Wired network connection If the Handheld Base Unit from Roche Diagnostics is used to connect this meter to a local area network, the Handheld Base Unit must be protected against unauthorized access by means of a strong password management.
Wireless connectivity If the meter is equipped with WLAN functionality: Wireless connectivity allows the meter to send data (test results, patient IDs, operator IDs, etc.) to the data management system without the need to return the meter to the Handheld Base Unit. This feature must be configured by the system administrator. Observe the guidelines of your facility for using wireless local area network connections.
The Industrial, Scientific and Medical (ISM) radio frequencies may contain emissions from microwave ovens, heaters, and other noncommunication devices. While these types of devices usually pose no threat of interference as they are low-powered devices, the possibility exists that some industrial high power systems may wipe out any attempted communication use of a WLAN.
The CoaguChek Pro II system complies with FCC radiation exposure limits set forth for an uncontrolled environment. This equipment should be installed and operated with minimum distance of 20 cm (8 inches) between the radiator and your body. This transmitter must not be co-located or operated in conjunction with any other antenna or transmitter. Changes or modifications made to this equipment not expressly approved by Roche Diagnostics may void the FCC authorization to operate this equipment.
The CoaguChek Pro II system complies with the emission and immunity requirements described in EN 61326-2-6. It has been designed and tested to CISPR 11 Class B. This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation.
Quality control To ensure that the meter functions properly, please observe the following guidelines: ■ Only use the meter at a room temperature between 12 °C and 32 °C (54 °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, vibrationfree surface, or hold it so it is roughly horizontal.
1.
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 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. E Barcode scanner The integrated barcode scanner can scan operator, patient, and QC sample IDs into the meter.
1.4 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 155. Button/Icon Meaning Go to Main Menu OK; save setting Cancel; discard setting Return (to previous menu) Decrease/increase the value displayed. Scroll through lists that are too long to be displayed all at once.
Button/Icon Meaning Apply sample (the time left to apply sample is counted down in the display) Apply liquid control (QC) sample (the time left to apply sample is counted down in the display) Insert the test strip code chip QC QC %Q SEC INR 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.
Button/Icon Meaning Room or meter temperature is outside the acceptable range The test strip guide cover is open Reports a status message (see: Chapter 9, Troubleshooting) Reports an error message or a warning (see: Chapter 9, Troubleshooting) QC! Lockout, one or more parameters are locked The following icons may appear when using the meter in conjunction with a data management system (DMS).
Power supply The CoaguChek Pro II meter is operated with the rechargeable battery pack. Insert the battery pack even when using the power adapter. This ensures that you will not lose the date and time settings if the power goes out. The power adapter also serves as a charger for the battery pack. To save power, the CoaguChek Pro II meter has an automatic power-off function (auto-off). The default setting is 5 minutes of inactivity (e.g., no screen touches).
Main Menu 09:15 am During battery operation, the meter always displays the battery power level. Patient Test When replacing the battery pack, insert the new battery pack within 24 hours of removing the old one. Otherwise you may need to re-enter date and time. Control Test The meter retains results in memory even when no battery pack is inserted. All settings other than date and time are retained as well.
Putting the Meter into Operation Before using the meter for the first time, perform the following steps: 1 Install the battery pack 2 Connect the power adapter to charge the battery pack 3 Set the current date and time 4 Enter your chosen settings (language, unit of measure, user administration if applicable, etc.
2.1 Installing or replacing the battery pack When shipped, the battery pack is not installed in the CoaguChek Pro II meter. Unused battery packs lose their charge over time and have to be recharged before they can be used. After installing a new battery pack, the meter should be charged for two hours before testing. Please note that the battery pack will only reach full capacity once it has been fully emptied and charged several times.
Removing the battery pack 1 If a battery pack is already installed, make sure that the meter is powered off. 2 Place the meter face down on a level surface. 3 Using a an appropriate starshaped screwdriver, e.g. Torx® size T5, remove the four screws holding the battery compartment cover in place. 4 Remove the battery compartment cover from the meter. The battery pack now visible is connected to the meter by a plug. 5 Carefully lift the battery pack and remove the plug connector.
Installing the battery pack 1 Loosen the screws on the battery compartment cover until they are protruding about 4-5 mm (2/10 in). 2 Hold the battery pack in your hand, with the wires and the plug pinched between your thumb and index finger. 3 Plug the connector plug into the socket. 4 Place the battery pack inside the battery compartment as shown above.
5 Place the cover on the battery compartment. Make sure that – the plug connector wires do not get pinched between meter and cover – the protrusion on the battery compartment cover fits into the corresponding groove on the battery compartment rim Tighten all four screws until snug (do not overtighten).
After inserting a new battery pack, the meter powers on automatically. The Roche logo is displayed. If the meter does not power on automatically, the battery pack may be empty. Connect the power adapter for a minimum of 30 minutes, then remove the plug and try to power the meter on. If it powers on, the battery pack is charging properly. ■ Within a short period of time, the start screen should appear.
2.2 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. You can also power on the meter directly by inserting a test strip, connecting the power adapter, or by docking it in the Handheld Base Unit. 3 To power the meter off after use, press the button for approximately 1 second.
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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.
Main Menu 09:15 am Patient Test Control Test Review Results Setup Setup Menu 05/29/2015 Screen Options ID Setup QC Settings Diagnostics 05/29/2015 09:15 am 1 Touch Setup to open the meter settings. 2 Select the relevant group of settings (see the Settings summary following this section.).
Settings summary The diagram below shows all of the setup areas that can be accessed on the meter. Setup Screen Result Confirmation Contrast Date / Time Language Selection Result Units Options Sort Parameter Selection Auto Off Beeper Connection ID Setup Admin. Operator Patient Lockouts Scan QC Material Hardware Wireless Setup QC Settings QC Range Diagnostics General Software Memory Usage Meter Setup • 3 3.
Group Screen Subgroup Contrast Setting Result Units Result Confirmation Language Selection Date/Time Date Time Date formats Time formats Values * 0 – 10 (5 *) INR * INR/SEC INR/%Q Enable Disable * Dansk Deutsch English * Español Français Italiano Nederlands Norsk Português Suomi Svenska 01/01/2015 * 12:00 am * DD.MM.YYYY (01.01.
Options Subgroup Sort Beeper Setting Beeper Key Click Auto Off [minutes] Connection QR Code Parameter Selection ID Setup Admin. (Administrator) Operator (Operator List is optional) Patient Values * Date/Time * Patient ID Patient Name Off Low Medium * High Off * On Off 1 … (5*) … 10 15 20 25 30 40 50 60 Off * Computer Printer Off * On Enable Disable * Blank (Off) * Inactive * Active No * Optional Required * Default settings are labeled with an asterisk (*).
Group QC Settings Subgroup QC Range Lockouts Setting PT Values * Default Range* aPTT Operator Lockout (only if the Operator option is set to Active and an operator list is available) Custom Range Off * Weekly Monthly Every 3 months Every 6 months Yearly Number of levels New code (Yes/No) Scheduled QC Lockout – No* – Daily – Weekly – Monthly Number of hours Number of strips For each option except “No”: STAT Test Config.
3.2 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.
Result Units Main Menu Use this setting to select the unit(s) in which the result is displayed. This setting only applies to PT test results. Regardless of the settings chosen for PT, aPTT is always displayed in seconds.
Result Confirmation Main Menu 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.
Language Selection Main Menu Use this setting to select the meter language. 09:15 am Setup Menu 09:15 am Screen 09:15 am Contrast Screen Patient Test Options Result Units Control Test ID Setup Result Confirmation Review Results QC Settings Language Selection Setup Diagnostics Date / Time 05/29/2015 05/29/2015 05/29/2015 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.
09:15 am 4 Dansk Deutsch English Español to display the language of choice If the arrow is just an outline , you have reached the end of the list in the repective direction. 5 Touch the button to select the language of choice. Your selection is now highlighted. 6 Touch to save this setting, or touch to exit this menu without saving any changes. The display automatically returns to the previous screen. Français 05/29/2015 Setting the date Touch or on the screen.
Main Menu 09:15 am Setup Menu 09:15 am Screen Screen Contrast Options Result Units 09:15 am Patient Test Control Test ID Setup Result Confirmation Review Results QC Settings Language Selection Setup Diagnostics Date / Time 05/29/2015 05/29/2015 05/29/2015 Date/Time 09:15 am Set Date 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. 4 From the Date/Time menu, touch Set Date.
Setting the time Main Menu When you power on the meter for the first time (or after a long period without power), this Time 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.
Setting the display options for date and time Main Menu Select your preferred format for the date and time display. 09:15 am Setup Menu 09:15 am Screen Screen Contrast Options Result Units 09:15 am Patient Test Control Test ID Setup Result Confirmation Review Results QC Settings Language Selection Setup Diagnostics Date / Time 05/29/2015 05/29/2015 05/29/2015 1 From the Main Menu, touch Setup to open the meter settings. 2 From the Setup Menu, touch Screen.
09:15 am 5 Touch the button with the display format of choice for date and time. Your selection is now highlighted. 6 Touch to save this setting, or touch to exit this menu without saving any changes. The display automatically returns to the previous screen. 7 Touch Set Date Set Time Format Format Date: 05/29/2015 09:15 am to return to the Screen menu. DD.MM.
3.3 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 Pro II meter. You can display stored results chronologically by date and time or by person, based on the Patient ID.
The current setting is highlighted. You may select from the following sort options: 09:15 am By Date/Time ■ By Patient ID ■ By Patient Name 4 Touch the button to select the Sort by option of choice. Your selection is now highlighted. Sort By: Date / Time Patient ID Patient Name 05/29/2015 The sort option Patient Name is available only when used together with a patient list. Patient lists can only be created with a DMS. For more details see “Data handling”, starting on page 139.
Beeper The CoaguChek Pro II meter can display information visually and alert you to special circumstances with a Beeper. The meter always beeps when it is switched on.
09:15 am Main Menu Setup Menu 09:15 am Options Screen Sort Options Beeper 09:15 am Patient Test Control Test ID Setup Auto Off Review Results QC Settings Connection Setup Diagnostics Parameter Selection 05/29/2015 05/29/2015 05/29/2015 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. The current setting is highlighted.
Auto Off Main Menu You can set up your CoaguChek Pro II 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 battery pack.
09:15 am Auto Off You may select from the following options: Minutes: 5 ■ 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 to save this setting, or touch to exit this menu without saving any changes. The display automatically returns to the previous screen.
QR Code Connection 09:15 am 4 From the Connection menu, touch QR Code. 5 Touch On to enable, or touch Off to disable QR code display. Your selection is now highlighted. QR Code Off 09:15 am QR Code Show QR code: On Computer Printer Off If you have enabled this feature, select the style of the QR code to be displayed: ■ Plain Text Coded Data 05/29/2015 URL Transmission 05/29/2015 Plain Text Use this option to scan the result into a PC hosted application (e.g. electronic medical record).
If you have selected URL Transmission, the button will become active. Use this button to set the additional parameters. 09:15 am QR Code Show QR code: On Off Plain Text 7 Touch Coded Data 8 Touch URL to enter the URL to which the test result data will be uploaded (note: the URL will be provided by your specialized service provider). ■ Use 123 to switch to input of numbers. ■ Use ABC to switch back to input of text.
URL Transmission 10 09:15 am URL Encryption Key Encryption Key 05/29/2015 09:15 am Key: JD5G29F6U8V2WC4L Serial No.: UQ85464711 Note: The encryption key and the serial number are required to decrypt QR code messages from this meter. Ensure they are available on the target system. 05/29/2015 Touch Encryption Key to display the Encryption Key menu. The Encryption Key menu displays two types of information which are required in order to identify and decode the transmitted test result.
Computer The CoaguChek Pro II 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 or the meter must be configured for wireless communication. If no wireless communication is configured, the connection is established in two steps. ■ The meter connects to the Handheld Base Unit via infrared.
Printer The CoaguChek Pro II meter can also connect directly to a printer. To use the printing feature you need an optional infrared printer. Main Menu 09:15 am Setup Menu 09:15 am 09:15 am Options Sort Screen Patient Test Options Beeper Control Test ID Setup Auto Off Review Results QC Settings Connection Setup Diagnostics Parameter Selection 05/29/2015 05/29/2015 05/29/2015 Connection 09:15 am 1 From the Main Menu, touch Setup to open the meter settings.
Parameter Selection Main Menu When performing a test, the meter can be set to display a screen that allows the operator to select the test parameter to be used. Otherwise the meter will determine the test parameter by reading the test strip (barcode) information from the inserted test strip.
3.4 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.
■ Patient: The Patient ID is assigned to the person, whose test results are recorded. You can either: – block input of a unique Patient ID (in this case, every test is simply numbered in consecutive order) – allow a unique Patient ID as optional, or – require a unique Patient ID for every test. Patient lists created externally can also be transferred to the meter, enabling you to select Patient IDs for a test from these lists. For more details see “Data handling”, starting on page 139.
System Administrator (Admin.) In the default setting, the meter is not protected with an Admin. ID, and all setup options are accessible to every user. If you set up an Admin. ID, the following setup areas are automatically reserved only for the system administrator/supervisor (i.e., the person who knows the password).
09:15 am Admin. ***| A B C D F G H I J K L M N O P Q R S T U V W X Y E 123 09:15 am Admin. | Using the keypad displayed on the screen, enter the Admin. ID of choice. The ID 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). 5 Use 123 to switch to input of numbers. 6 Use ABC to switch back to input of text.
Changing an existing Admin. ID: Main Menu 09:15 am 09:15 am Setup Menu 09:15 am Admin. Screen ***| Options 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 ID Setup 09:15 am Admin. Patient Test Operator Control Test ID Setup Review Results QC Settings Setup Diagnostics Z 05/29/2015 Patient 123 05/29/2015 05/29/2015 1 From the Main Menu, touch Setup to open the meter settings. 2 From the Setup Menu, touch ID Setup.
Deactivating an existing Admin. ID: Main Menu 09:15 am 09:15 am Setup Menu 09:15 am Admin. Screen ***| Options 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 ID Setup 09:15 am Admin. Patient Test Operator Control Test ID Setup Review Results QC Settings Setup Diagnostics Z 05/29/2015 Operator Patient 09:15 am Admin. | A B C D F G H I J K L M N O P Q R S T U V W X Y From the Main Menu, touch Setup to open the meter settings.
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 139). 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.
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 139). 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. Main Menu 09:15 am Setup Menu 09:15 am 09:15 am ID Setup Admin.
09:15 am Patient ID Alphanumeric Numeric Min. Length: 6 ■ 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. 7 Touch the button with the format of choice for the Patient ID. Your selection is now highlighted.
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 Diagnostics in the code chip. ■ Custom Range: The option Custom Range lets the user define their own QC Range within the default range.
QC Range Main Menu Liquid quality control ranges can be customized to comply with local guidelines. The QC Range function enables you to narrow the default range individually for each test parameter. 09:15 am Setup Menu 09:15 am QC Settings 09:15 am QC Range Screen Patient Test Options Control Test ID Setup Review Results QC Settings Setup Diagnostics Lockouts Scan QC Material 05/29/2015 05/29/2015 05/29/2015 1 From the Main Menu, touch Setup to open the meter settings.
If you selected Default Range, touch to save this setting, or touch to exit this menu without saving any changes. ■ If you selected Custom Range, touch to proceed with corresponding settings, or touch to exit this menu without saving any changes. The display automatically returns to the previous screen.
09:15 am QC Range Display target value On 6 Touch On (the target value will be displayed with a test result) or Off (the target value will not be displayed). Your selection is now highlighted. 7 Use the arrows to to set the allowed percentage deviation from the target value. Off Deviation from target value 11.5 % Use the arrows on the left to adjust the number before the decimal point. Use the arrows on the right to adjust the number after the decimal point.
QC (quality control) Lockout 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. QC Lockout is disabled by default. For routine confirmation of system reliability it is recommended to enable this feature. It is also possible to enable Operator Lockouts and QC Lockouts in parallel.
You may select from the following options: 09:15 am QC Lockout New Code Yes No ■ No New Code Yes/No (applies every time a new test strip lot is used) The general intervals are: Daily Weekly Monthly New Code No ■ Daily ■ Weekly 09:15 am ■ Monthly No 05/29/2015 QC Lockout ■ ■ No. of Hours Weekly ■ No. of Strips Monthly 6 Touch the button with your chosen option when changing the test strip lot. 7 Touch and on the screen. Yes No. of Hours No.
09:15 am QC Lockout New Code QC Lockout 09:15 am Number of strips (1-999): Yes QC Lockout 09:15 am Number of Levels No Weekly One Level 450 Monthly Two Levels No. of Hours No. of Strips 05/29/2015 05/29/2015 8 Touch the button to select the interval of your choice. Your selection is now highlighted. 9 Touch to proceed, or touch without saving any changes. 10 If you have selected either No. of Hours or No. of Strips, enter the corresponding number now.
Operator Lockout Optional liquid quality controls can be used to ensure that an operator is performing tests properly on the CoaguChek Pro II 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. Main Menu 09:15 am 09:15 am Setup Menu Screen QC Settings 09:15 am Lockouts 09:15 am QC Range QC Lockout Lockouts Operator Lockout Scan QC Material STAT Test Config.
Op. Lockout 09:15 am Op. Lockout 09:15 am Op. Lockout 09:15 am Number of Levels No Weekly Weekly Monthly One Level Two Levels Monthly Every 3 Months Every 3 Months Every 6 Months Every 6 Months Yearly 05/29/2015 5 05/29/2015 Select the interval of choice in which the mandatory quality control tests must be performed. You may select from the following options: ■ No (deactivated) ■ Weekly ■ Monthly ■ Every 3 Months or Every 6 Months ■ Yearly 6 Touch and on the screen.
STAT Test Configuration Quality control tests ensure consistent quality and accurate measurements. In emergency situations, however, it may be necessary to perform a test without delay. To override an active lockout1, you can allow STAT Tests (STAT = Short TurnAround Time). You can set the number of tests (up to nine) permitted beyond the lockout. Once the number of STAT Tests allowed has been reached, additional tests cannot be performed until you have successfully completed a quality control test.
09:15 am Main Menu 09:15 am Setup Menu Screen QC Settings 09:15 am 09:15 am Lockouts QC Range QC Lockout Lockouts Operator Lockout Scan QC Material STAT Test Config. Patient Test Options Control Test ID Setup Review Results QC Settings Setup Diagnostics 05/29/2015 05/29/2015 05/29/2015 05/29/2015 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 Lockouts.
Scan QC Material Main Menu The barcode scanner of the CoaguChek Pro II meter can be used to scan barcodes from QC material vials. 09:15 am Setup Menu Screen 09:15 am 09:15 am QC Settings QC Range Patient Test Options Control Test ID Setup Review Results QC Settings Setup Diagnostics 05/29/2015 Scan QC Material 05/29/2015 Scan QC Mat. 09:15 am 05/29/2015 05/29/2015 1 From the Main Menu, touch Setup to open the meter settings. 2 From the Setup Menu, touch QC Settings.
3.6 Diagnostics Under Diagnostics, you will find information about the system, such as software version, number of data records stored, and configuration details. The diagnostics screens shown here are for illustration purposes only. The Information shown on your meter may differ.
09:15 am General Meter name: CoaguChek Pro II 09:15 am Software Home location: Mannheim Last synchronization: 05/28/2015 Hardware 09:15 am 04.00.00 Build: Boot: 00.16.31 Kernel: 00.21.30 Rootfs: 00.16.01 Memory Usage Patient Tests: in use/max. (no.): Serial no.: U76001234 HBM HW: 3.53a 03 Control Tests: in use/max. (no.): 350/500 Patient List: in use/max. (no.): 2700/4000 1250/5000 App: 04.00.00 MM-BL: 0.80 Operator List: in use/max. (no.
4 Testing a Blood Sample What you need: ■ CoaguChek Pro II meter ■ CoaguChek PT and/or aPTT Test Strips with matching code chip ■ When testing with venous blood: – Standard blood collection device (syringe) ■ 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.
Protection against infection: When collecting samples always observe the general precautions and guidelines relating to blood sampling (see page 17). Dispose of all test strips used for patient testing in accordance with the disposal policy of your laboratory or practice (see page 17) Never … CAUTION ■ store the meter at high temperatures (above 35 °C or 95 °F) while it is in regular use. ■ store the meter in damp or humid conditions without protection.
Getting a good capillary blood sample Prepare the selected blood collection site and obtain blood from the patient per facility policy. If no facility policy exists for obtaining capillary blood, follow these recommendations: ■ 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, disinfect the blood collection site. Dry thoroughly. ■ Have the patient let that arm hang down by his or her side before lancing a finger.
Getting a good result from venous whole blood For sample collection use a standard blood collection device. Do not use anti-coagulants (e.g., EDTA, citrate, fluoride, oxalate, or heparin) to collect the blood sample. Venous blood samples may be collected from a venous line. If venous samples are collected by venipuncture, note the following: ■ Use a needle at least 23 G (approx. 0.65 mm) or larger in size. ■ Discard the first four drops of blood collected (within the first 10 seconds).
4.2 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 box of test strips (PT, aPTT) contains a code chip. The parameter, 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.
Inserting the code chip 1 Remove the old code chip, if one is inserted in the meter. 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, a corresponding error message appears in the display (refer to the “Troubleshooting” section of this manual).
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 . 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 139). If the function Operator ID is inactive: Main Menu 09:15 am 3 Wait until the Main Menu is displayed.
If the function Operator ID is active: Without operator list: 3 You are now prompted to enter an Operator ID1. ■ Enter the Operator ID using the keypad. Touch to move to the next screen. ■ Alternatively, the Operator ID can also be entered using the built-in barcode scanner2. Touch Scan and scan the operator barcode from a distance of approx. 10-20 cm (4-8 inches), according to the barcode size. The meter beeps once the barcode has been read successfully.
With operator list: 09:15 am Operator Alan Smithee 3 Wait until the operator list is displayed. 4 Select the operator of choice by touching the corresponding button or touch Scan to scan an operator barcode. Jane Brown Ann Casey Joe Dalton Note: Scanned operator IDs must also be on the list. Otherwise the login attempt will fail and an error message will be displayed. Scan 05/29/2015 09:15 am Password | 0 1 2 3 4 5 6 7 8 9 ABC Main Menu 09:15 am 5 Enter the (optional) password.
4.3 Performing a test 1 09:15 am Main Menu 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 by pressing . ■ Patient Test Control Test Review Results Setup In both cases, restore power by recharging the battery pack, or using the power adapter.
Without patient list 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 ID1. ■ If Required, enter the Patient ID, then touch move to the next screen. ■ If Optional, ignore the prompt and touch to move to the next screen. The meter will assign the test a consecutive number.
With patient list 09:15 am Test New 09:15 am Patient ID | PID01 Smith, Henry PID02 Jones, Walther PID03 Hamilton, Fran PID04 Miller, Ted PID05 Reed, William Scan 05/29/2015 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 E Scan 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.
Alternatively, the Patient ID can also be entered using the built-in barcode scanner1. Touch Scan and scan the patient barcode from a distance of approx. 10-20 cm (4-8 inches), according to the barcode size. 1. A list of supported barcode symbologies can be found in Appendix A.2 on page 166, a list of supported characters in Appendix A.3 on page 169. Testing a Blood Sample • 4 The meter beeps once the barcode has been read successfully. The barcode information appears in the patient ID field.
If the Parameter Selection option is enabled in the meter settings, you are now prompted to select the parameter to be tested. The testing procedure for both parameters is similar. For illustration purposes testing with PT test strips is shown as an example. 09:15 am Test PT aPTT Test 09:15 am P-ID: PID01 Müller, David Op: Schulz Par: PT 05/29/2015 05/29/2015 8 Touch the button to select the parameter you want to use. 9 The test strip icon prompts you to insert a test strip.
09:15 am Test P-ID: PID01 Smith, Henry Op: Operator 1 Par: PT 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. 05/29/2015 Test If you use a new test strip lot and have not inserted the code chip yet, you must do so now. Otherwise you cannot perform a test. The meter displays the number of the code chip belonging to the new test strip lot.
Applying blood from the fingertip 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. 12 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.
Applying blood with a syringe Discard the first four drops of blood collected (within the first 10 seconds). Then immediately apply one drop of blood (at least 8 μL, but not more than 20 μL) directly onto the target area of the test strip. Ensure that no air bubbles are introduced into the sample. If too much blood has been applied (> 20 μL) the exterior of the meter and the test strip guide should be cleaned and disinfected.
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. 09:15 am Test P-ID: PID01 Smith, Henry Op: Operator 1 Par: PT Code: 184 Do not add more blood. To avoid error messages do not touch the test strip until the result is displayed. 05/29/2015 The meter performs an automatic quality control test on the test strip before it displays the test result. “QC” appears in the display.
Test 09:15 am P-ID: PID05 Müller, David Op: Schulz Par: PT Code: 208 05/29/2015 09:14 am 1.6INR C If a “C” is displayed along with the result: This may occur if the hematocrit value is very low or due to erroneous blood collection (e.g., wet hands). Repeat the test. If using capillary blood, make sure that the patient's hands are dry. If the message persists, perform a hematocrit check. 05/29/2015 09:15 am 1.
Accepting or rejecting a test result Test 09:15 am P-ID: PID01 Smith, Henry Op: Operator 1 Par: PT Code: 184 05/29/2015 09:14 am ■ Reject or ■ Accept If you reject a result, you must enter a comment with an explanation. 2.5INR 21%Q If you reject the result, this test result is no longer displayed. However, the test entry is stored. Measurement Result OK? Reject If this function is enabled, you may choose to accept or reject a test result.
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: 09:15 am 2.5INR 21%Q 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.
Displaying the test result as QR code Test 09:15 am P-ID: PID01 Smith, Henry Op: Operator 1 Par: PT Code: 184 05/29/2015 11:31 am Test 2.5INR 21%Q 09:15 am The QR code icon only appears if the QR code display function is activated (see page 64 and following). Otherwise it is not displayed. 1 Touch to display the result as QR code. 2 Touch to return to the standard result display. The size of the QR code displayed on the screen varies according to the amount of data encoded.
STAT tests STAT tests are a limited number of tests that can be performed in emergency situations, see page 88. 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. 09:15 am Main Menu 09:15 am Test 09:15 am Test PT QC status Patient Test QC! STAT Info PT aPTT - 3 - Locked aPTT I-011 Control Test 3 STAT tests remaining before lockout.
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5 Control and Proficiency Testing 5.1 Control testing The CoaguChek Pro II 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. ■ An onboard quality control within every single test strip.
5.2 Preparing to perform 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.
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.
5.3 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 . You can also power on the meter directly by inserting a test strip or connecting the power adapter. 3 Wait until the Main Menu is displayed, or log on as described on page 100. 4 Check the battery level. If the battery icon turns red (one bar left), there may not be enough power left for another test.
Main Menu 09:15 am 09:15 am QC Test 09:15 am QC Test Control Test Control Test Par: Op: Patient Test 09:15 am QC Test PT PT Schulz aPTT Proficiency Test Review Results Setup 05/29/2015 05/29/2015 05/29/2015 6 Touch Control Test. 7 In the QC Test menu, touch Control Test again. 8 Touch the button to select the parameter you want to use. 9 The test strip icon prompts you to insert a test strip.
QC Test 09:15 am QC Test Op: Operator 1 184 09:15 am New Code QC 070 QC 060 QC 050 QC 048 Scan 05/29/2015 05/29/2015 If you are using a new test strip lot and have not inserted the test strip code chip yet, you must do so now. Otherwise you cannot perform a quality control test. 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.
09:15 am QC Test Code: 184 Par: Op: Operator 1 PT If the code chips get mixed up, check the letter on the code chips to tell them apart. 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. QC 05/29/2015 QC Test QC: 999 Code: 184 Par: Op: Operator 1 09:15 am PT 13 If performing more than one level, select the level for this measurement.
14 Using the dropper, draw up the dissolved contents of the bottle. 15 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.
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. The result of the liquid quality control test is displayed. It is automatically saved to memory. The acceptable range of results for the liquid control is displayed below the current result, along with Pass or Fail.
QC Comment 09:15 am Acceptable Cntrl. 16 If you want to add a comment, touch 17 Select the desired predefined comment(s) from the pick list (if configured) or 18 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. 19 Once you have selected the desired comment(s), touch to return to the results screen.
Proficiency testing Observe the applicable regulations and directives of the responsible regulatory agencies when performing proficiency tests. Proficiency tests are performed on samples whose values are unknown to the operator performing the test. These samples are provided by an external source, and the results should be forwarded to the appropriate source after completing the test. The samples supplied are treated in the same manner as regular patient samples.
5.5 Preparing to perform a proficiency test You prepare for a proficiency test in the same way you would prepare to perform a test with a capillary blood sample. The only difference is the use of the proficiency sample supplied instead of blood from a patient. To perform a proficiency test you need the following: ■ The information of at least one code chip for test strips must be stored in the meter and must match the lot number of the test strips used. ■ The correct test strips must be available.
Performing a proficiency 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 . You can also power the meter on directly by inserting a test strip or connecting the power adapter. 3 Wait until the Main Menu is displayed, or log on as described on page 100. 4 Check the battery level. If the battery icon turns red (one bar remaining), there may not be enough power available for another test.
Main Menu 09:15 am QC Test 09:15 am Proficiency 09:15 am Patient Test Control Test Proficiency Test Control Test Review Results Setup 05/29/2015 05/29/2015 05/29/2015 6 Touch Control Test. 7 Touch Proficiency Test. For proficiency testing, the test parameter information is read from the test strip. 8 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.
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 09:15 am Proficiency QC: 202 Code: 101 Par: aPTT 09:15 am Proficiency QC: 202 Code: 101 Par: aPTT E 1:35 Min. 05/29/2015 11 05/29/2015 Enter or scan the sample ID. 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 proficiency sample.
09:15 am Proficiency QC: 202 Code: 101 Par: aPTT 09:15 am Proficiency QC: 202 Code: 101 Par: aPTT 06/03/2015 11:30 am 51.6 SEC Proficiency 05/29/2015 12 05/29/2015 Apply a single drop of the sample directly from the dropper to the semicircular, transparent sample application area on top of the test strip. Do not add more of the sample. You hear a beep when you have applied enough of the sample (provided the beeper is enabled). The dropper icon disappears and the test starts.
Review Results (Memory) The CoaguChek Pro II 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 120 code chip records (contents of 60 test strip code chips and 60 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 the memory is full when you perform a test, the oldest result is automatically deleted.
6.1 Viewing test results Main Menu 09:15 am Patient Test Control Test Review Results Setup 05/29/2015 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 3 Wait until the main menu is displayed. .
Main Menu 09:15 am Memory 09:15 am 09:15 am Memory All results Patient Test Patient Result PT QC Result aPTT Control Test Review Results Setup 05/29/2015 05/29/2015 4 Touch Review Results. 5 Select the type of results you want to view. ■ Display Patient Result memory ■ Display QC Result memory 6 Select the test parameter(s) you want to view. For displaying patient results: Parameter selection is only available, if the sort order has been set to “Date/Time” (see page 58).
Display patient result memory This memory area contains all patient test results. They are sorted according to the order you defined for the option Sort (see page 58). If the Sort option is set to Date/ Time they are filtered by means of the test parameter you previously selected, the most recent results are at the top of the list.
QC 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. 09:15 am 09:15 am Memory QC: 999 Level: 1 Code: 184 Par: PT Op: Operator 1 05/28/2015 11:31 am QC 999 Pass 05/27/2015 10:05 am QC 234 Pass 05/28/2015 11:31 am 1.2 INR Pass: 05/26/2015 10:07 am QC 623 Pass (1.0 - 1.
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7 Extended Functionalities 7.1 Data handling Note: Extended data handling functionality is dependent on the capabilities of the particular Data Management System (DMS) being used and may vary. ■ Transferring patient lists, operator lists, and settings from the DMS to the meter. In this way the setup for daily work as well as general meter setup can be performed (for one or more meters) quickly and conveniently.
Through the DMS the system administrator (such as the POC coordinator) may specify what settings are to be applied to a set of meters within a site or unit (e.g., hospitals or wards). All meters assigned to a specific site and/ or unit would consequently share the same settings. The different operator and patient lists (that match a site or unit) are then made available on their respective meters.
For initial connection to a DMS, the ability to communicate within a network has to be set up as follows: ■ In the Setup Menu, the Connection option must be set to Computer (see page 63). ■ The Handheld Base Unit must be configured correctly. (For details please refer to the manual of the Handheld Base Unit and the Technical Note stored on the Handheld Base Unit itself.) ■ Place the meter on a Handheld Base Unit that is connected to the network.
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.
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).
■ The Patient ID is set to Optional or Required, and there is a list available: The list of Patient IDs is always shown when starting a measurement. You may now: – select a patient from the list; – scan a Patient ID using the barcode scanner; – create a new patient entry by touching New. You may either read the ID using the barcode scanner or enter a new ID via the onscreen keypad.
Configuring operator and patient IDs When creating operator and patient IDs, apply the following rules: ■ Patient IDs can consist of up to 20 alphanumeric characters, with specified minimum and maximum lengths. ■ Operator IDs can consist of up to 20 alphanumeric characters. Alphanumeric characters are any combination of A - Z and 0 - 9, additionally “.” (period), or “-” (hyphen) may be used.
The default preset comments in the meter are: Patient result comments QC result comments ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ Asymptomatic Cleaned Meter Doctor Notified Sick Travel Lab Draw No Action Procedure Error Under Medication Will Repeat Test Changed Dosing ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ Acceptable Control Cleaned Meter Doctor Notified New Control Lot New Lot Number New Strip Lot New Strip/Kit Lot No Action Procedure Error Proficiency Test Repeat Control Test RN Notified Switched QC Vial Will Repeat Test For
8 Maintenance and Care 8.1 Conditions for storage and shipping Storage ■ Store the system and test strips in the same environment in which they are used. ■ Do not store the meter in direct sunlight or under extreme temperature conditions. ■ Observe the limits for temperature and humidity when storing and using the meter (see Chapter 10).
Shipping Observe the following safety information when shipping the meter and battery pack. Failure to do so may result in injury to persons or damage to the meter or battery pack. ■ If the meter is shipped or transported over long distances, always remove the battery pack from the meter. This eliminates the possibility of the battery pack overheating due to a short-circuit in the meter. It also prevents deep discharge and other damage to the battery pack or meter.
8.2 Cleaning and disinfecting the meter Difference between cleaning and disinfecting Cleaning is the physical removal of organic soiling (e.g., dirt, or other foreign material) from the meter surface. Disinfecting is the removal of most, but not all, diseasecausing and other types of microorganisms (blood-borne pathogens) from the meter. What to clean and disinfect? ■ Clean the meter to remove visible soil and organic material for safe handling and/or prior to disinfecting.
Observe the disinfection guidelines of your institution. ■ Use gloves. ■ Follow the instructions given below to clean and disinfect the meter. Failure to follow these instructions may cause malfunction of the meter. NOTICE Instrument damage due to moisture Ensure that no liquid enters the meter. If moisture enters the meter, it may cause malfunction of the instrument. ■ Make sure the meter is turned off. ■ Do not spray anything onto the meter housing. ■ Do not spray into the test strip guide.
Recommended cleaning/disinfecting agents Use only the following solutions for cleaning/disinfecting the meter (housing and test strip guide). NOTICE ■ A soft cloth slightly dampened (not wet) with a small amount of liquid soap diluted in water ■ Rubbing alcohol (70% ethanol or isopropyl alcohol) ■ Alcohol-based disinfectant (a mixture of 1-propanol (400mg/g), 2-propanol (200 mg/g) and glutaraldehyde (1.
8.4 Cleaning/disinfecting the exterior (meter housing) Use the solutions recommended on page 151 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 Power off the meter. Then gently wipe over the surfaces (touchscreen, housing) with a soft, lint-free cloth slightly dampened (not wet).
Cleaning/disinfecting the test strip guide Use the solutions recommended on page 151 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 With the meter powered off, 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.
NOTICE Damage to the instrument ■ Ensure that no liquid enters the meter when cleaning the test strip guide. 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: 8.6 3 With the cover off, let the test strip guide dry for at least 10 minutes before re-attaching the test strip guide cover and testing again.
9 Troubleshooting The CoaguChek Pro II 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.
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. Additional information on error E-406 Error message Touch to exit this message. Perform the suggested step(s) to solve the problem. 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.
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 Meter display does not power on Wait 10 seconds and try powering on the meter again.
Meter reset A meter reset should only be performed if all other remedies have failed. 1 Place the meter on a level surface. 2 Press the On/Off button for at least 12 seconds. ■ The meter powers off and on again. ■ The Roche logo is displayed. If the Roche logo does not appear within 60 seconds, place the meter in the Handheld Base Unit for a minimum of 15 minutes to recharge the battery. ■ The meter performs a system check. ■ The screens for entering the date and the time appear.
10 General Product Specifications 10.1 Technical data Temperature range +12 °C to +32 °C (54 °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.
Storage conditions Temperature range Meter (without battery pack) –25 °C to +70 °C (-13 °F to +158 °F) Temperature range Meter (with battery pack)* –10 °C to +35 °C (+14 °F to +95 °F) Relative humidity 10 to 85 % (no condensation) * At temperatures above +70 °C/158 °F the battery pack could leak and damage the meter. At temperatures below -10 °C/+14 °F the battery pack does not have enough power to keep the internal clock functioning.
10.
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.PDF”) on the CD supplied with this manual.
Repairs Please note that repairs and other modifications to the meter may only be performed by persons authorized by Roche Diagnostics. Contact Roche For all questions about the CoaguChek Pro II system that are not answered in this manual, contact your Roche Diagnostics representative. If you do not already have contact details: ■ Visit our website at www.roche.com.
11 Warranty The statutory guarantee provisions on rights in consumer goods sales in the country of purchase shall apply.
A Appendix A.1 Operator and patient ID barcode masks Barcode mask character Definition A-Z, 0-9 If not preceded by the Caret (“^”), the scan data character must be the same as the mask character. This character is not saved as part of the ID. If the characters are not the same, the scan data is not a valid ID. Dollar (“$”) The scan data character in this position is kept as part of the ID. Asterisk (“*“) The scan data character in this position is not kept as part of the ID.
A.2 Example of barcode symbologies If a barcode is read incorrectly, this may lead to patient misidentification and therefore to inappropriate therapy decisions. When creating patient or operator barcodes, always adhere to the applicable international IEC/ISO standards for the respective barcode symbology. In particular, ensure that barcode size and print quality (as defined in ISO/IEC 15416 and 15415) are adequate. Inadequate print size and/or quality may lead to erroneous decoding.
WARNING Avoidance of incorrect EAN 13 and Interleaved 2/5 barcode readings EAN 13 and Interleaved 2/5 barcodes, although widely used, are not recommended for patient/operator barcodes. If an EAN 13 or Interleaved 2/5 barcode is read incorrectly, this may lead to patient misidentification and therefore to inappropriate therapy decisions.
Codabar Code 39 Code 93 Code 128 EAN 13 Interleaved 2/5 PDF417 QR Code DataMatrix
Supported characters in 2D barcodes The 2D barcode scanner is able to read characters from the following unicode ranges: ■ Basic Latin (0021-007E) ■ Latin-1 Supplement (00A1-00FF) ■ Latin Extended-A (0100-017F) The 2D barcode scanner does not support Asian characters. Appendix • A A.
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B Appendix B.1 Supplement for Observed Test Sequence 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. This assessment is saved together with the test result and any desired comments.
Using the OTS function Main Menu 09:15 am A request for an Observed Test Sequence comes from the DMS. The presence of the icon on the Patient Test button indicates a pending OTS request. 09:15 am Pat. Test - OTS Observer 09:15 am Pat.
Pat. Test - OTS 09:15 am Remove 09:15 am Observer Login 09:15 am Observer OTS passed: I-010 OTS enabled Observer ALAN SMITHEE, please log in to proceed. Otherwise the OTS test will not be complete. Observer Login Fail Reject Accept Comment: Patient Test 05/29/2015 05/29/2015 Operator: 1 Touch Patient Test. Perform the patient test as usual. Once the test is completed, the observer has to complete the next steps. 2 Hand the meter back to the observer.
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C Appendix C.1 Option: Wireless network (WLAN) Preliminary note This appendix has been developed to explain the wireless communication principles of the CoaguChek Pro II system1 and to help your facility’s information technology/management team(s) in effectively deploying the CoaguChek Pro II system on your wireless network. Whether your meter has wireless capability or not depends on the system configuration that you purchased.
Background The CoaguChek Pro II meter can only be configured through a data management system to communicate wirelessly. The data management system (DMS) is also used to set-up and configure the meter to connect to one hospital specific Wireless Local Area Network (WLAN1). WLANs use electromagnetic waves in the 2.4 GHz frequency range to wirelessly transmit data2. The CoaguChek Pro II system adheres to IEEE Standard 802.11g (2.4 GHz range)3. The system is backwards compatible to 802.11b.
Prior to connecting any wireless device to a wireless network, it is recommended that a WLAN site survey be performed. The goal of a WLAN site survey is to ensure that Access Points will provide enough coverage and performance to support any new radio frequency (RF) application or device. The survey will also detail RF signals, including all existing WLANs along with any competing RF signals and interferences (building structure related and other wireless equipment / devices).
The current RF system consists of an antenna and a WLAN system-on-chip (SoC) along with other components. The WLAN system-on-chip is the core of the WLAN system. The RF system used in the CoaguChek Pro II meter specifically adheres to the following specifications: ■ Its WLAN system-on-chip supports IEEE 802.11b and 802.11g. It works seamlessly together with other Wi-Fi certified transceivers.
The CoaguChek Pro II system offers the option of wireless network connectivity (WLAN/Wi-Fi). This module can only be configured by a data management system (DMS), which activates the meter’s wireless communication and data transfer capabilities. Wireless connectivity can help to ensure that updates to information in the DMS are sent immediately to all networked meters.
■ The CoaguChek Pro II meter is capable of transferring to a suitable DMS, via WLAN, a data set of up to 1000 result records, 100 strip and control lot records, and 500 operator ID records in less than 15 minutes, when operated in a typical WLAN environment (correct WLAN administration, typical population of other clients present, any of the supported security models enabled).
A typical range for direct connection between the CoaguChek Pro II meter and the access point (air, direct view, low disturbances) is up to 15 to 20 meters (49 to 66 feet). The actual range depends on the positioning of the access point’s antennas and other topological properties of the space between WLAN device and AP. Additionally, dynamic control of the transmitting power of the access point may reduce the maximum distance between WLAN device and AP within which communication can be guaranteed.
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Index D M Data transfer .................................................139–141 Mains voltage ................................................. 27, 159 Date ..............................................................................54 Measurement Disinfection ...................................................150–154 Performing .............................................102–115 Preparing ............................................................97 Index Display A Format .....................
Measuring range .................................................. 159 Quality Control Lockout .....................................................83, 102 Memory Memory ............................................................ 137 Button ............................................................... 135 Preparing ......................................................... 118 Patient Result ................................................. 136 Result .................................................
STAT test Configure ...........................................................88 Perform ............................................................ 115 Storage ..................................................................... 147 Switching on the meter ........................................99 Symbols Error messages ............................................. 155 System Administrator .....................................72–75 T Target value ....................................................
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