Administrator s Guide ALYX Component Collection System Codes/ 4R5707 4R5725

Transcription

1 Administrator s Guide ALYX Component Collection System Codes/ 4R5707 4R5725 Administrator s Guide ALYX Software Release 3.0 Instrument Serial Number: January 2009

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3 Administrator s Guide Table of Contents SECTION PAGE DATE General Description 1 01/2009 Purpose 1 01/2009 Warnings and Cautions 3 01/2009 Administrative Settings Selections 4 01/2009 Remote Interface Selections 4 01/2009 Accessing Administrative Settings 5 01/2009 Resetting the Password 8 01/2009 Regional Language, Date and Unit Measurement Formatting 11 01/2009 Procedure Selection 13 01/2009 Enabling Kit Codes 15 01/2009 Viewing or Modifying Nomogram Target Volume Settings 16 01/2009 Setting Cuff Pressure and Draw and Return Rates 19 01/2009 Setting Absolute Red Cell Volumes: Double Unit and Single 20 01/2009 Recovered Unit Data Configuration Tool 23 01/2009 Remote Interface 26 01/2009 Glossary of Graphics 37 01/2009 Glossary of Terms 40 01/2009 Parts Replacement and Product Revalidation 42 01/ January 2009 i

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5 Revision Status Record Document Control Number Revision Date Software Version Number Pages Revised Signature and Date January 2009 iii

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7 General Description The Administrative Guide provides instructions and recommendations for using the ALYX Component Collection System, with software release 3.0 and supports instrument model numbers 4R5707 and 4R5725. This guide is intended for use by trained blood center administrative personnel who have read the ALYX Component Collection System Operator s Manual and are familiar with the operation of the ALYX Instrument. The Administrative Guide should always be used concurrently with the Operator s Manual. Purpose Administrative Settings Administrative Settings allow the administrator/center to customize the instrument settings and simplify entries of donor and procedure parameters to help manage the data from collection procedures. These settings include: selecting or modifying default settings, adding or removing procedures, kit codes, solutions, and filter(s), if applicable, and to set up specific parameters to manage data for the entry and documentation of donor and procedure information. Refer to the list of Administrative settings for all selections available. Entry into Administrative Settings requires the use of a password. The default password should be changed by the administrator before setting up the procedure parameters for their region. Operational checks will have to be repeated after new procedures are enabled on the instrument. Refer to the ALYX Component Collection System Operator s Manual, Chapter 3, Initial Instrument Set-Up. Remote Interface - Administrative Setup Mode and Procedure Summary Data The Remote Interface section describes how the ALYX instrument can be attached via an Ethernet cable to a personal computer (PC) to allow access to Administrative Setup and Procedure Summary Data. Entry into Administrative Setup Mode requires the use of a password January

8 Procedure Summary Data can be viewed and individually printed via an attached printer. A password is not required to access this section. Data Export is an additional feature that may be enabled by a qualified service representative. Contact Fenwal for additional information. Glossaries A Glossary of the terms and a listing of specific Graphics have been included to help the administrator become familiar with the instrument s settings and how they are used to create customized procedures. A more complete Glossary of Graphics and Terminology may be found in the ALYX Component Collection System Operator s Manual. ALYX Parts Replacement and Product Revalidation This section contains recommendations for product revalidation when a qualified service representative services or replaces instrument parts January 2009

9 Warnings and Cautions The Warnings and Cautions found in this guide are specific for using the ALYX Instrument to access and make selections in Administrative Settings. WARNING: Do not attach a donor to the ALYX Instrument when in Administrative Settings. CAUTION: The touch screen is the main input device for the instrument. Do not touch the screen during operation except to interact with the instrument. CAUTION: Do not press the STOP button prior to the STOP button test. CAUTION: Do not operate the instrument if the display is blank, unreadable, or if the instrument does not respond to the touch screen commands January

10 Administrative Settings Selections Remote Interface Selections The settings that can be customized are: Change the Password Formatting Options o Regional Language o Date o Unit Measurement Height Weight Hematocrit/Hemoglobin Temperature Enable/Disable Procedures and Kit Codes o Regions (Per Country) o Select Target Volumes (Per Region) Default for Cuff Pressure o Venipuncture and Procedure Defaults and Upper Limits for Draw and Return Rates Absolute Red Cell Volumes o Minimum Absolute Red Cell Volume (2RBC) o Enable/Disable Single Unit Recovery o Target Absolute Red Cell Volume (SUR) Data Configuration o Red Cell Filter Button o Saline Button o Donor ID o ABO Button Blood Type Heart Rate Blood Pressure Temperature Administrative Setup o Regional Setup o Instrument Setup Administrator Password Software Installation This feature is not currently enabled. Language Installation o Settings Report Procedure Summary January 2009

11 Accessing Administrative Settings To access Administrative Settings, turn the instrument on and perform the STOP Test. The operator may perform the scale checks and/or enter the operator ID, if desired. Note: Do not enter a procedure type or kit code. Typical Perform STOP Test Screen 1. Touch the information button after the STOP button test is completed. The typical Donor Information Overlay will be displayed. Information Button WARNING: Do not attach a donor to the ALYX Instrument when in Administrative Settings. CAUTION: Do not press the STOP button prior to the STOP button test. Note: Procedure screens used in this manual are for general illustration. These screens and actual instrument screens may vary January

12 2. Touch the instrument settings tab on the Donor Information Overlay similar to the one displayed below. Instrument Settings Tab 3. Touch the login button. Typical Donor Information Overlay Login Button Typical Instrument Settings Overlay 4. Enter the default password FENWAL on the alphanumeric login keypad. Note: The default password should be changed to prevent entry by unauthorized individuals. Please refer to the following section, Resetting the Password, and follow the instructions provided January 2009

13 Typical Login Keypad Screen 5. Touch the check button on the keypad screen. Check Button Typical Regional Language, Date and Measurement Overlay The Regional Language, Date and Unit Measurement Overlay will be displayed after the administrator successfully enters valid login information. All the options are grouped into tabs with icons to help identify the settings available. Implementing Changes To select an option, touch the appropriate tab and make the choice(s) for that setting. Exiting the tab and/or touching the check button will save the new selections. To continue making selections, touch another tab. It is not required to power down or turn off the instrument for the new settings to take effect. If the check button is touched on the Regional Language, Date and Unit Measurement Overlay, it will be necessary to login again. If an alarm occurs while in Administrative Settings, any unsaved changes will be cancelled, and the user is logged out January

14 Resetting the Password Resetting the Fenwal password will prevent or limit the accidental entry into a center s procedure settings. After Administrative Settings has been accessed, use the following steps to set up a new password or follow the instructions provided in Accessing Administrative Settings. Typical Regional Language, Date and Unit Measurement Overlay 1. Touch the administrative password tab and an overlay similar to the following will be displayed. Administrative Password Tab Typical Change Password Overlay January 2009

15 New Password Button 2. Touch the new password button on the overlay and enter the new password on the keypad. Touch the check button. Typical Login Keypad The Change Password Overlay will change to indicate that the new password has been entered. Typical Change Password Overlay - New Password Entered Confirm Password Button 3. Touch the confirm password button and enter the password again using the keypad. The Change Password Overlay will change to indicate that the confirmed password has been entered January

16 Typical Change Password Overlay - Confirm Password Entered Note: If a misspelled or mismatched password is entered, a mismatch alert will highlight both buttons and cause an audible alert to sound. Both entries will be cleared and will have to be reentered correctly to change the password. Check Button 4. The new password will be activated by either continuing to select or edit settings or by touching the check button. 5. To exit out of Administrative Settings touch the check button. Note: Once a new password is confirmed, the default password FENWAL can no longer be used. It is recommended that the new password be documented and stored in a safe location. If this password is lost, a qualified service representative will have to be contacted to reset the password January 2009

17 Regional Language, Date and Unit Measurement Formatting Regional Language, Date and Unit Measurement Tab Example Menu Button Typical Regional Language, Date and Unit Measurement Overlay 1. Touch the regional language, date and unit measurement tab, if needed, to return to the Regional Language, Date and Unit Measurement Overlay. 2. Touch the down arrow on the language menu button to open up the selection menu. 3. Touch the desired selection or use the up and down arrows to change the selection. 4. Touch the date format menu button to select the date configuration appropriate for your region. Note: A menu button allows the selection of an option from a list that is displayed when the button is touched. A representation of a touched or opened menu button is shown below. Example of an Opened Menu Button Showing Options Available January

18 5. Touch the down arrow on each of the donor parameters to select the type of measurement unit to be used for height, weight, red cell content and temperature. 6. Touch the check button to confirm the selections or select another tab. Check Button Note: Touching the check button on the overlay will close the Regional Language, Date and Unit Measurement Overlay and your password will have to be re-entered in order to make additional selections or changes. Touching another tab will act as a confirmation of the current choices made and allow further selections. 7. To exit Administrative Settings, touch the check button January 2009

19 Procedure Selection The procedure selection tab allows the administrator to choose procedure types and modify settings specific for each procedure. For each procedure that is enabled, a kit code, region, and target volume(s) must be selected. Note: The next and previous buttons on the procedure selection screen will appear grayed out and will not function if there is only one procedure available. Procedure Selection Tab 1. Touch the procedure selection tab to access the Procedure Selection Screen similar to the one shown below. Previous Button Typical Procedure Selection Screen Next Button 2. Touch the next or previous buttons, if applicable, to select from the supported procedures January

20 Procedure Settings Button 3. To select a procedure, touch the procedure settings button. An enable kit code overlay similar to the one displayed below will open. Typical Enable Kit Code Overlay Operational checks will have to be repeated after new procedures are enabled on the instrument. Refer to the ALYX Component Collection System Operator s Manual, Chapter 3, Initial Instrument Set-Up January 2009

21 Enabling Kit Codes The enable kit code overlay allows the administrator to enable or disable the desired kit codes that are associated with each procedure. Note: Additional kit code prefixes or suffixes may appear on actual kit labeling. Typical Kit Code Overlay, 2RBC Selected 1. To enable a kit code, touch the checkbox located next to the desired kit codes. Note: At least one kit code must be checked or the selected procedure will be disabled, and the nomogram target volume settings tab and the pressures and rates setting tab will not be available. 2. Touch the check button or select another tab to enable or disable the selected kit code(s). Check Button Note: The kit settings tab may be used to return to the enable kit code overlay. Kit Settings Tab January

22 Viewing or Modifying Nomogram Target Volume Settings 1. Touch the nomogram target volume settings tab to select desired target volumes according to your region and the center s applicable standard operating procedures for the selected procedure. Nomogram Target Volume Settings Tab Typical Nomogram Target Volume Settings Overlay 2. Touch the region menu down arrow button to select the region, if applicable. If the region is gray, as displayed in the above overlay, no other choices are available on the region menu button. 3. Touch the desired region, if available. After the region is selected, the overlay will display the allowable target volume options for that procedure type and selected region. Typical Nomogram Target Volume Setting Overlay Regions Available for Selection Note: Kit code numbers are specific for different countries. After the kit code is selected, only the region(s) that apply to those code(s) will be available for selection January 2009

23 4. Touch the target volume checkboxes on the overlay to enable or disable the allowable target volumes for the selected procedure according to your center s applicable standard operating procedure. Typical Nomogram Target Volume Settings Overlay Note: A minimum of one target volume for each procedure must be selected for each enabled procedure. If no volumes are selected, the administrator will not be able to exit or choose another tab. The tabs and the check button will be grayed out similar to the screens displayed below. Typical Nomogram Target Volume Settings Overlay No Volumes Selected 5. Touch the target default down arrow button to set the default target collection volume to maximum or minimum. Minimum Sets the target default at the lowest volume that is checked. Maximum Sets the target default at the highest volume that is checked January

24 For example, if both 360 ml and 400 ml allowable collections volumes are checked, a maximum setting will target the 400 ml volume, if the donor parameter inputs qualify. Setting the target default to minimum does the opposite, 360 ml will be the target default even if the donor criteria allows a larger collection. Note: If another region is selected, any changes made to the target volume checkboxes previously will be lost, unless they fall within the default target volumes of the new region selected. 6. Touch the check button to confirm the target volume selections, or touch another tab to continue. Check Button January 2009

25 Setting Cuff Pressure and Draw and Return Rates 1. Touch the cuff pressure and rates setting tab. The Cuff Pressure and Rates Setting Overlay displays the current default settings for the cuff pressure at venipuncture and during the procedure. The draw and return rate upper limit and default values are also displayed in a screen similar to the one shown below. Cuff Pressure and Rates Setting Tab Typical Cuff Pressure and Rates Setting Overlay The administrator can set up center defaults and upper limits for the cuff pressure and the draw and return rates, if desired. 2. Touch the venipuncture menu down arrow button to modify the default setting for the cuff pressure at venipuncture. 3. Touch the up and down arrow buttons to select the desired default venipuncture cuff pressure setting. 4. Touch the desired default venipuncture cuff pressure setting. 5. Repeat these steps to set the following: Default procedure cuff pressure Upper limits for draw and return rates Default draw and return rates Note: Default settings cannot exceed the upper limit settings. Check Button 6. Touch the check button to implement these settings and return to the Procedure Selection Screen. Touch the check button on the Procedure Selection Screen to confirm all changes and to exit out of Administrative Settings or touch another tab to continue January

26 Setting Absolute Red Cell Volumes: Double Unit and Single Recovered Unit The absolute red cell volume tab allows the admininistrator to set the minimum absolute red cell volume for a double recovered unit. In addition, the administrator has the ability to enable Single Unit Recovery and set the absolute red cell target volume for a Single Unit Recovery (SUR) unit. If the procedure has been terminated with a collected red cell volume that meets the 2RBC minimum absolute red cell volume for the procedure (defined via Administrative Settings), the collected red cells will be processed as a double unit. The Procedure Information Screen will display a product exemption message to inform the operator that the product needs to be checked. Testing should be performed to check absolute red cell content/volume for product acceptability per institutional guidelines. Refer to the ALYX Component Collection System Operator s Manual Chapter 4A or 4C, Performing Post- Collection Processing. Note: The 2RBC minimum absolute red cell target volume in the US is 360 ml, and the collection tolerance is ±10%. 1. Touch the absolute red cell volume tab as displayed on the following screen. Absolute Red Cell Volume Tab Typical Absolute Red Cell Volume Screen 2. To change the double unit minimum absolute red cell volume touch the minimum absolute red cell volume entry field and enter the appropriate volume on the volume keypad. Note: In the US, the double unit minimum absolute red cell volume must be set equal to or greater than 324 ml (360mL - 10%). Note: Outside the US, the double unit minimum absolute red cell volume will depend on country regulations January 2009

27 If the conditions are not met for the double unit recovered collection, but are met for the Single Unit Recovery (SUR) collection, the instrument will collect a single unit. The Procedure Information Screen will display a product exemption message to inform the operator that the product needs to be checked. Testing should be performed to check absolute red cell content/volume for product acceptability per institutional guidelines. Note: SUR must be enabled separately for the 2RBC-LR and 2RBC-NLR procedure(s). Note: The absolute red cells collected will be no less than the Single Unit Recovery target volume 10% (target defined via Administrative Settings), and no more than the maximum single unit volume. 3. Touch the checkbox labeled Single Unit Recovery to enable SUR. Checkbox Typical Absolute Red Cell Volume Screen Single Unit Recovery Enabled Note: The absolute red cell target volume for a Single Unit Recovery (SUR) unit in the US is limited to 180 ml. Therefore, a US SUR unit should contain 180 ml ± 10% absolute red cells, with the maximum single unit volume being 198 ml. Note: The absolute red cell target volume for a Single Unit Recovery (SUR) unit from a Functionally Closed Kit should be set at a value from , with the maximum single unit volume being 220 ml. 4. Touch the single unit recovery volume entry field to change the absolute red cell target volume of the single unit January

28 Check Button Typical Keypad Overlay SUR Target Volume 5. Touch the check button on the SUR target volume keypad overlay after the appropriate volume is selected. Typical Absolute Red Cell Volume Screen 6. Touch the check button on the Absolute Red Cell Volume Screen to confirm the volumes, or choose another tab to continue with administrative options January 2009

29 Data Configuration Tool Data Configuration Tool Tab The data configuration tool tab is used to enable the following options: Barcoding (for data entry parameters) o Operator ID o Solutions o Donation ID o Donor ID To display the following: Red Cell Filter Button Saline Button Donor ID Button ABO Icon Post-leukoreduction Product Recovery (%) Icon 1. Touch the data configuration tool tab and the overlay will be displayed. Red Cell Filter Button Saline Button Typical Data Configuration Tool Overlay-Page One 2. Touch the down arrow on the Operator ID setting to select the barcode format to be used. Select Keypad Only if no barcode is desired. 3. The barcode format for the ALYX disposable kit is only available in the displayed UCC/EAN 128 format. In addition, the ALYX disposable kit code can always be entered using the Keypad. 4. Touch the red cell filter check box to enable the red cell filter button to be displayed on the Main Data Entry Screen, if desired. Note: The plasma and platelet filter buttons are not currently available. 5. Touch the saline check box to enable the saline button to be displayed on the Main Data Entry Screen January

30 6. Touch the down arrow on saline setting to select the valid barcode format used by the facility. Note: The saline button will only be available when the functionally closed kit code(s) has been enabled. 7. Touch the next button on the Data Configuration Tool Overlay to access the second page. Next Button Donation ID Button Donor ID Button ABO Icon Post-leukoreduction Product Recovery Icon Typical Data Configuration Tool Overlay-Page Two Note: The Platelet Additive Solution (PAS) button is not currently available. 8. Touch the down arrow on the donation ID setting to select the valid barcode format used by the facility or select Keypad Only if no barcode is desired. Note: The donation ID button is required and cannot be turned OFF. 9. Touch the donor ID checkbox to enable the donor ID button. Touch the down arrow on the donor ID setting to select the valid barcode format used by the facility or select Keypad Only if no barcode is desired. 10. Touch the ABO checkbox to enable the ABO icon, if desired. Note: When the ABO icon is enabled, a Donor Parameter Screen will automatically be displayed with entry fields that allow the donor s blood type, heart rate, temperature, and blood pressure readings to be entered, if desirable. 11. Touch the post-leukoreduction product recovery icon checkbox to enable the display of the product percent recovery calculation on the Procedure Information Screen at the end of a procedure. 12. Touch the check button to confirm all the parameters have been selected or touch the previous button on the overlay to return to page one to review the selections made January 2009

31 13. Touch another tab to continue or touch the check button again to exit Administrative Settings. Barcode Information Valid barcode formats available for use with ALYX can be found in Chapter 7, Specifications. The barcode example displayed below has a series of numbers under the barcode which impart the same information that is included in the barcode itself. Enter all numbers and letters displayed under the barcode, disregarding any special characters. The barcode on the ALYX disposable includes the kit code, lot number, and expiration date. After the barcode on the kit is scanned, the data is automatically applied to the correct locations on the kit data overlay. Required solutions or accessories not supplied by Fenwal may not be formatted to correctly place the information read or scanned into the appropriate location(s). The barcode information should be verified to ensure it has been placed in the correct location January

32 Remote Interface The Remote Interface allows access to Administrative Setup and Procedure Summary Data via a personal computer (PC). Entry into Administrative Setup Mode requires the use of a password. Procedure Summary Data can be viewed and individually printed via an attached printer. A password is not required to access this section. PC Setup - Direct Connection Please ensure the following equipment is available: ALYX instrument Personal computer with Ethernet port Ethernet crossover cable Printer (optional) 1. Turn ON the ALYX instrument and perform the scale test. 2. Touch the information button on the Data Entry Screen. 3. Touch the administrator tab on the Donor Information Tab Overlay. Administrator Tab Network Settings Button Typical Donor Information Tab Overlay 4. Touch the network settings button on the touch screen. Note: The network settings button provides the IP address and subnet mask for the specific settings used to connect ALYX to a PC. 5. The IP address will be displayed on the IP Address and Subnet Mask Overlay. Note: If the ALYX instrument is on a network, the Use DHCP will be checked. Use the IP address displayed at the top right corner. The IP and Subnet Mask fields will be grayed out January 2009

33 Typical IP Address and Subnet Mask Overlay 6. Connect one end of the ethernet crossover cable to the ethernet port on the PC. 7. Connect the other end of the ethernet crossover cable to the ethernet connection port (Port 3) on the back of the ALYX instrument. Note: The location of the Ethernet port is displayed in the ALYX Component Collection System Operator s Manual, Chapter 2, Connection Ports. 8. Turn ON the personal computer (PC). 9. Open Network Connections, click Start, click Control Panel, and then double-click Network Connections. Note: Modification of network settings may vary based on PC operating systems. If the ALYX instrument is connected to a network, please contact your local Network Administrator. 10. Double-click on Local Area Connection to open the local area connection settings. 11. Click on Properties to modify the network settings January

34 Typical Local Area Connection Status 12. Scroll down and select Internet Protocol (TCP/IP), then click on Properties to modify the network settings. Typical Local Area Connection (Network) Properties January 2009

35 13. Select Use the following IP address. 14. Enter the IP address. The first three fields should be identical to the IP address taken from the ALYX instrument. In the example above, X. The X needs to be different from the ALYX instruments. This number can vary from Enter the Subnet mask identical to the one taken from the ALYX instrument and click OK. Typical Internet Protocol (TCP/IP) Properties 16. Click OK to save the Local Area Connetion Properties. 17. Close all Local Area Connection windows. 18. The PC is now configured to connect to the ALYX instrument January

36 Administrative Setup Mode 1. Touch the enable administrative setup mode button. Enable Administrative Setup Mode Button Typical Enable Administrative Setup Mode 2. Touch the yes button to confirm entry into the administrative setup mode. Typical Confirm Access to Administrative Setup Mode Note: If the enable administrative setup mode button is touched, and entry into this mode is confirmed, the instrument must be power cycled to exit January 2009

37 Typical Administration Screen to Remote Interface A screen similar to the one displayed above will appear on the ALYX instrument to acknowledge entry into Remote Interface. This screen will continue to be displayed until the stop button is touched, and the instrument is power cycled OFF. 3. To access the ALYX instrument open up an Internet broswer and type the IP address of the ALYX instrument. Typical Default Procedure Summary Remote Interface Note: If the Administrator Setup Mode is not entered on the ALYX instrument, the Procedure Summary Screen is displayed without the option to select Administrative Setup. Procedure summaries may be viewed or printed, but no other selections are available when using this option January

38 Remote Interface is divided into two sections: Administrative Setup o Regional Setup o Instrument Setup o Settings Report Procedure Summary Administrative Setup Administrator Password Software Installation This feature is not currently enabled. Language Installation 1. Place the cursor on the Administrative Setup folder and click to access. 2. The Administrative Setup page will displayed. An Operator ID and a valid password must be entered to make any selections or changes in Remote Interface. Typical Enter Password Remote Interface Note: The Administrator password used for accessing Administrative Settings is the same password used for Remote Interface, Administrative Setup. 3. Enter the Operator ID and Administrator password and click on the Check Button. The Administrative Setup page will be displayed January 2009

39 Typical Administrative Setup Remote Interface Click on the + next to the Administrative Setup to expand the folder options. Regional Setup This selection allows the administrator to change the language setting. 1. Click on Regional Setup and open the language menu to choose the language. Note: The default language is English. Typical Select Language Remote Interface 2. Select the desired language, if available, and click on the Save button. A confirmation screen will be displayed January

40 Instrument Setup Click on the + next to the Instrument Setup to expand the folder options. This selection allows the administrator to change the password, install software and add additional languages as approved and cleared by health regulating agencies. 1. Click on Administrator Password if a new password is desired. Note: Only ISO-8859, also known as Western Latin, character set is acceptable. CAUTION: Using a keyboard character set that does not meet the ISO-8859 standard to change the Administrator s password may result in Administrator access issues, both on Remote Interface and the ALYX Instrument. Typical Change Password Remote Interface 2. Enter a new password. The confirmed password must match the new password. Click Save to change the password otherwise click Cancel.. Software Installation The software installation option is not currently enabled. Language Installation This selection allows the Administrator to add or update a language file January 2009

41 1. Select the Browse button to locate the language file desired. Typical Language Installation Remote Interface 2. Click on the Add/Update Button after the language file has been selected. A confirmation screen will be displayed. The new language will be added to the Installed Language list. Settings Report 1. Click on the Settings Report to view a report of the ALYX instrument and network settings. 2. Click on the Print button to print the Settings Report if desired. Procedure Summary 1. Click on Procedure Summary and a list of previous procedures will be displayed. 2. Scroll down to view the procedure list. 3. Click on the Donation ID of the desired procedure to be viewed January

42 Donation ID Typical Procedure Summary Remote Interface 4. Click on the Print button to print a procedure summary. Click on Procedure Summary to view and/or print additional procedures. Note: Printing is limited to individual procedures only. Selecting a list of two or more procedures for printing is not currently available. Print Button Typical Procedure Summary Information Page 5. To exit Remote Interface, click on the Logout Button located at the top right corner of the page. 6. If the ALYX instrument is in the Administrative Setting Mode, Touch the STOP button on the ALYX instrument and turn the instrument OFF after exiting Remote Interface January 2009

43 Glossary of Graphics This glossary provides the names and/or meaning of tabs, buttons, icons, and prompts used with the ALYX Administrative Guide. Buttons are defined as graphics that are displayed on the touch screen that require operator interaction to command the instrument to proceed to the next step or verify a procedure step has been completed. Tabs provide a link to the data that is available for either viewing or entering. Each tab has specific buttons for entering individual pieces of data. Tabs/Buttons/Icons Name ABO Icon Absolute Red Cell Volume Tab Administrator Password Tab Administrator Tab Check Button Checkbox Cuff Pressure and Rate Settings Tab Data Configuration Tool Tab January

44 Tabs/Buttons/Icons Name Donation ID Tab Donation ID Icon Donor ID Icon Enable Administrative Setup Mode Information Button Instrument Settings Tab Kit Settings Tab Login Button Menu Button Minimum Absolute Red Cell Volume Tab Network Settings Button Next Button January 2009

45 Tabs/Buttons/Icons Name Nomogram Target Volume Settings Tab Previous Button Procedure Selection Tab Procedure Settings Button Red Cell Filter Button Post-leukoreduction Product Recovery Icon Regional Language, Date and Unit Measurement Tab Saline Button January

46 Glossary of Terms This glossary provides definitions for acronyms and terms used in the Administrative Settings. Button Icon IP Address Menu Button A graphic displayed on the touch screen that needs to be touched by the operator in order to initiate an action by the instrument, verify a step, or proceed to the next part of the procedure. Graphics displayed on the touch screen or instrument that provide the operator with additional information or guidance. An Internet Protocol (IP) address is a numerical identification (address) that is assigned to devices participating in a computer network utilizing the IP address for sending and receiving information. A graphic displayed on the touch screen that is used when a list of choices exist. The current selection is displayed and, when touched, offers a list of selectable options. Network Settings Nomogram Provides information about the IP address and subnet mask for the specific settings used to program the instrument to be accessible via an Ethernet connection to a computer system. Table listing requirements for male and female donors that indicate the maximum blood component donation volumes for a specific procedure using the ALYX Component Collection System according to applicable country regulations. Note: The nomogram tables may be found in the Appendix section of the ALYX Component Collection System Operator s Manual. The Target Default Maximum and Minimum Menu Button uses the volumes from these tables for the various procedures according to the applicable country regulations of the region selected January 2009

47 Remote Interface Subnet Mask Status Zone Tabs Remote Interface allows the connection of the ALYX instrument to a personal computer (PC) via an Ethernet cable. A subnet mask is a way of telling a computer or router what network addresses it can consider local and which are remote. The upper left corner of the operating display touch screen, which shows the operator identification number, the time, and the information button. A graphic displayed on the touch screen that is touched to provide additional areas for entering or viewing data January

48 Parts Replacement and Product Revalidation After service replacements on ALYX instrument subassemblies by qualified service representatives, the customer must determine when instrument revalidation is required to ensure continued product quality. Fenwal recommends product revalidation at the customer site when the interface detector (ID) sensor is replaced. Customer revalidation is not recommended by Fenwal for replacement of any other field serviceable parts. For customer revalidation requirements related to software upgrades, consult your service representative January 2009

49 Manufactured for: Fenwal, Inc. Lake Zurich, IL USA Fenwal Europe sprl B-1435 Mont-Saint-Guibert Made in USA FENWAL, ALYX, ALYX Component Collection System, and ALYX (triangle logo) are registered trademarks of Fenwal, Inc. Manufacturer Authorized Representative in the European Community 2008 Fenwal, Inc. All rights reserved January 2009