Bio-Rad Laboratories Q U A L I T Y C O N T R O L. My einserts. User Guide

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1 Bio-Rad Laboratories Q U A L I T Y C O N T R O L My einserts User Guide

2 Contents Introduction Log On to My einserts ways to access My einserts Log Out of My einserts Get Help to My einserts Select a Language for the My einserts Website Create an Electronic Insert Step : Select a Product, Lot, and Language Step : Customize My einserts Choose from the Method or Instrument Chart After You Complete Your Selections Step 3: Name Your Custom einserts My Saved einserts View Saved einserts Print a List of Saved einserts Print Saved einserts Edit Saved einserts Duplicate Saved einserts Delete Saved einserts Register as a QCNet User Update Your QCNet Account Information Register for Notification Updates View Peer Group Reports Terms of Use

3 Introduction My einserts allows you to create a customized control product insert. You can customize the product insert to include the specific combination of text, data chart, and language used in your laboratory. You can view and print a custom insert after you create it. You can save your custom selections as a PDF file to your computer or a network, and print the insert. You can also save the custom insert on My einserts. The advantages of saving on the My einserts website are: You can edit your selections at a later time. You can duplicate your selections to a new lot of the same product when you have a lot switch. You can register to receive notifications from Bio-Rad when insert updates are available based on the customized selections you have saved to My einserts. Note: To save a customized insert and receive data updates, you must be registered on and your selections must be saved on My einserts. Registration is free of charge. See Register as a QCNet User on page 7 and Register for notification updates on page 9 for more information. Bio-Rad Laboratories

4 Log on to My einserts Important: Make sure you disable all pop-blockers or allow pop-up windows to appear from the My einserts website. 3 ways to access My einserts Go to XXXXX represents the Bio-Rad control product lot number. Type the Bio-Rad control product lot number in place of XXXXX (for example, 340) to go directly to your product and lot selection. Go to to log on directly to My einserts. Go to and click the My einserts button. Log out of My einserts Click the Logout link when you are finished working on the My einserts website. Note: The Logout link only appears if you are logged in to the My einserts website. My einserts User Guide

5 Get help to My einserts Important: Make sure you disable all pop-blockers or allow pop-up windows to appear from the My einserts website. Located on the My einserts home page: Quick Start Guides Watch Video Tutorial User Guides My einserts User Guide 3

6 Select a language for the My einserts website Note: The default language for the My einserts website is determined by the language preference set up in your Internet browser or by the language selected when you log on to QCNet. Select your preferred language for My einserts from the Website Language list. 4 My einserts User Guide

7 Create an electronic insert Important: Make sure you disable all pop-blockers or allow pop-up windows to appear from the My einserts website. Step : Select a product, lot, and language Select the control product from the Product list. Select the lot number from the Lot list. Note: Lot numbers with an * (asterisk) cannot be customized. My einserts User Guide 5

8 3 3 Select the language for the insert from the Language list and then click Next. Note: If the language preference set up in your Internet browser is for English (United States) [en-us] and you select a non-english language for the insert, a message appears stating the insert may contain non-fda approved analytes. 4 Click OK if you agree to the message. 6 My einserts User Guide

9 Step : Customize My einserts Optional: Select the Add Instructions for Use check box to include the Instructions for Use with your custom insert or Click View & Print to view or print only the instructions. Note: The Instructions for Use (IFU) contains information about the control product in the language you selected for the insert. The Instructions for Use does not include data chart values Select your preferred Data Chart Units: Option Conventional SI (Standard International) Choose for Each Assay Description Select this option to apply conventional units to all analytes. Select this option to apply SI units to all analytes. Select this option to manually select the unit of measure for each assay. My einserts User Guide 7

10 Choose from the method or instrument chart i t Select the items you want to add to your custom insert: Click the Select All check box to add all methods or instruments in the chart. Click + (plus sign) to expand and view all choices. Click an individual check box to add an item or to add multiple items. Click the first check box for an item in the Method or Instrument chart to select all items (methods or instruments). Select the units for each item if you selected the Choose for Each Assay option. 8 My einserts User Guide

11 After you complete your selections Click View & Print Insert to view and save your selections to your computer. Click Save Selections and continue with the next section, Step 3: Name Your Custom einserts. (Requires QCNet login or new user registration. See Register as a QCNet User on page 7 for information about QCNet registration.) Step 3: Name your Custom einserts Click Save Selections located at the bottom of the page. Note: If you are not already logged in to QCNet, you are prompted to do so. See Register as a QCNet User on page 7 for information about QCNet registration Type a name for your custom insert and click Done. A message confirms your selections have been saved. 3 Click Close to close the message. My einserts User Guide 9

12 My saved einserts Important: Make sure you disable all pop-blockers or allow pop-up windows to appear from the My einserts website The advantages of saving your customized inserts on the My einserts website are: You can edit your selections. You can duplicate your selections to a new lot of the same product. You can delete your selections. Note: You must have a QCNet registration to save einserts. See Register as a QCNet User on page 7 for information View saved einserts Click the My Saved einserts link. 0 My einserts User Guide

13 Click the saved insert you want to view. Tip: Saved inserts appear in order by the saved date, with the most recent saved insert at the top The details of the saved insert appear. My einserts User Guide

14 Print a list of saved einserts Note: This only prints a list of your saved inserts; not the content of each insert Click the My Saved einserts link. The My Saved einserts page appears and shows a list of your saved inserts. Note: This only shows a list of your saved inserts; not the content of each saved insert Click Print List. The Print dialog box appears. 3 Select the options for your printer and click Print. My einserts User Guide

15 Print saved einserts Click the My Saved einserts link. The My Saved einserts page appears and shows a list of your saved inserts. Click the saved insert (in orange text) you want to print. Tip: Saved inserts appear in order by the saved date, with the most recent saved insert at the top 3 4 Click Edit/Print located at the bottom of the page. Click View & Print Insert. The File Download dialog box appears. My einserts User Guide 3

16 5 Click the appropriate button: Click Open to view and print the saved insert, or Click Save to save the insert to your computer to view and print later. Edit saved einserts Note: You cannot edit einserts if the lot number is expired. However, you can duplicate selections you have saved to a new, unexpired lot number Select the insert you want to edit and then click Edit/Print. 3 Edit the insert as necessary. Click Save Changes located at the bottom of the page. 4 My einserts User Guide

17 Duplicate saved einserts Note: You can duplicate a saved insert to duplicate your selections to a new lot of the same product or to create a new insert (with a new name) of the same lot number Click Duplicate. The Duplicate Your Custom Selection dialog box appears. Select the lot from the Lot list. My einserts User Guide 5

18 4 Type a name for the duplicated lot in the Name field. 4 5 Note: The duplicated insert must have a unique name 5 Click Duplicate and Review. Review your selections and make any changes as needed. 6 Click Save Changes if you made any changes. Delete saved einserts Note: Deleting einserts permanently removes them from the My einserts website. However, you can recreate an insert if needed. You can also save a copy of the insert to your hard drive or network before you delete it from the My einserts website. See After you complete your selections on page 9 for more information about saving inserts. Click Delete. A message appears asking for confirmation. 6 My einserts User Guide

19 Click OK. The insert is deleted. Register as a QCNet user Click the My QCNet Account link. Click Register. 3 Complete the information on the QCNet New User Signup page and click Submit. Note: An * (asterisk) indicates a required field My einserts User Guide 7

20 4 Click the Logout link when you are finished. A message appears asking for confirmation. 5 Click Log Out. Update your QCNet account information Click the My QCNet Account link. The QCNet My Account page opens in a separate window. Note: If you are not already logged in to QCNet, you are prompted to do so Edit your information as needed and click Update. A message appears stating the update was successful. 3 Click OK. 8 My einserts User Guide

21 Register for notification updates You can register to automatically receive notifications from Bio-Rad when insert updates are available based on the customized selections you have saved to the My einserts website. If Bio-Rad releases updated information for any assays which you have saved to a custom insert, you will receive an within 4-hours letting you know which product insert has been updated. Important: To receive Notification Updates via , you must: Register as a QCNet user (see page 7 for more information). Select the Receive notification for Insert Updates from Bio-Rad check box (described in this section). Save one or more custom inserts to the My einserts website. Make sure your software is set up so it does not block mail from Bio-Rad. Refer to the User Guide or Online Help for your software for more information Click the My QCNet Account link. The QCNet My Account page opens in a separate window. Note: If you are not already logged in to QCNet, you are prompted to do so My einserts User Guide 9

22 Select the Receive notification for Insert Updates from Bio-Rad check box and click Update. A message appears stating the update was successful. 3 Click OK. 0 My einserts User Guide

23 View peer group reports Click the My Unity Interlab Reports link. The UnityWeb page appears. Point to Reports and then click My Reports. The My Reports page appears Select a lab number from the Lab list. Select a lot number from the Lot list or select All Lots. Select the type of report you want to view or select All Report Types. Select a month for the report from the Period list. Point to Exit and then click Logoff when you are finished. My einserts User Guide

24 Terms of use Welcome to the Bio-Rad My einserts website and QCNet website Terms and Conditions (hereinafter referred to as Site Terms ). Please read these website terms of use carefully. By using this Site, you are agreeing to comply with and be bound by the following terms of use. Please review the following terms carefully. If you do not agree to these terms, you should not use this Site. By using our Site, you are agreeing to comply with and be bound by the following terms of use. Please review the following terms carefully. If you do not agree to these terms, you should not use this Site. Please be advised that not all products or services appearing at this website may be available in your geographic location. Acceptance of agreement You agree to the terms and conditions outlined in this Terms of Use Agreement ( Agreement ) with respect to our site (the Site ). This Agreement constitutes the entire and only agreement between us and you, and supersedes all prior or contemporaneous agreements, representations, warranties and understandings with respect to the Site, the content, products or services provided by or through the Site, and the subject matter of this Agreement. This Agreement may be amended at any time by us from time to time without specific notice to you. The latest Agreement will be posted on the Site, and you should review this Agreement prior to using the Site. Copyright The content, organization, graphics, design, compilation, magnetic translation, digital conversion and other matters related to the Site are protected under applicable copyrights, trademarks and other proprietary (including but not limited to intellectual property) rights. The copying, redistribution, use or publication by you of any such matters or any part of the Site, except as specifically allowed in this Agreement, is strictly prohibited. You do not acquire ownership rights to any content, document or other materials viewed through the Site. The posting of information or materials on the Site does not constitute a waiver of any right in such information and materials. Conflicting terms Certain sections or pages of this Site contain separate and/or additional terms and conditions, such as our Privacy Policy. In the event of a conflict, the separate and/or additional terms and conditions will prevail over the present terms of use for those sections or pages. Restrictions on use of content Except as authorized by law, you agree not to export or re-export the materials at this Site to any country, or to any person, entity, or end-user subject to U.S. export controls, including without limitation countries subject to U.S. embargoes or trade sanctions and persons or entities listed on the U.S. Department of Commerce Bureau of Export Administration's Denied Parties List and the U.S. Department of Treasury's Specially Designated Nationals. You may not use the materials at this Site, or any copy or adaptation thereof, in violation of any applicable laws or regulations including without limitation U.S. export laws and regulations. Subject to the foregoing, Bio-Rad authorizes you to view and download the materials at this Site solely for your personal, non-commercial use, provided that you retain all notices regarding Bio-Rad copyright and other proprietary rights that are contained in the original materials on any copies of the materials. The materials contained at this Site are owned by, and protected by, copyrights and other proprietary rights held by Bio-Rad and third parties. All rights reserved. You may not modify the materials at this Site in any way or reproduce or publicly display, perform, or distribute or otherwise use them for any commercial purpose. Disclaimers associated with website content YOUR ACCESS TO AND USE OF THIS SITE IS AT YOUR OWN RISK. THE INFORMATION, CONTENT AND DOCUMENTS FROM OR THROUGH THE SITE ARE PROVIDED AS-IS, AS AVAILABLE, WITH ALL FAULTS, AND ALL WARRANTIES, EXPRESS OR IMPLIED, ARE DISCLAIMED (INCLUDING BUT NOT LIMITED TO THE DISCLAIMER OF ANY IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE). THE INFORMATION AND SERVICES MAY CONTAIN BUGS, ERRORS, PROBLEMS OR OTHER LIMITATIONS. WE AND OUR AFFILIATED PARTIES HAVE NO LIABILITY WHATSOEVER FOR YOUR USE OF ANY INFORMATION OR SERVICE, EXCEPT AS SPECIFICALLY PROVIDED IN THIS AGREEMENT. IN PARTICULAR, BUT NOT AS A LIMITATION THEREOF, WE AND OUR AFFILIATED PARTIES ARE NOT LIABLE FOR ANY INDIRECT, SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES (INCLUDING DAMAGES FOR LOSS OF BUSINESS, LOSS OF PROFITS, LITIGATION, OR THE LIKE), WHETHER BASED ON BREACH OF CONTRACT, BREACH OF WARRANTY, TORT (INCLUDING NEGLIGENCE), PRODUCT LIABILITY OR OTHERWISE, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. THE NEGATION AND LIMITATION OF DAMAGES SET FORTH ABOVE ARE FUNDAMENTAL ELEMENTS OF THE BASIS OF THE BARGAIN BETWEEN US AND YOU. THIS SITE AND THE PRODUCTS, SERVICES, DOCUMENTS AND INFORMATION PRESENTED WOULD NOT BE PROVIDED WITHOUT SUCH LIMITATIONS. NO ADVICE OR INFORMATION, WHETHER ORAL OR WRITTEN, OBTAINED BY YOU FROM US THROUGH THE SITE OR OTHERWISE SHALL CREATE ANY WARRANTY, REPRESENTATION OR GUARANTEE NOT EXPRESSLY STATED IN THIS AGREEMENT. ALL RESPONSIBILITY OR LIABILITY FOR ANY DAMAGES CAUSED BY VIRUSES CONTAINED WITHIN THE ELECTRONIC FILE CONTAINING A FORM OR DOCUMENT IS DISCLAIMED. My einserts User Guide

25 BIO-RAD ALSO DISCLAIMS ALL LIABILITY FOR ANY INFORMATION AND MATERIAL CONTAINED IN ANY NON-BIO-RAD WEBSITES LINKED TO THIS SITE. A LINK TO A NON-BIO-RAD WEBSITE DOES NOT MEAN THAT BIO-RAD ENDORSES OR ACCEPTS ANY RESPONSIBILITY FOR THE CONTENT OR THE USE OF SUCH WEBSITE. IF YOU DECIDE TO ACCESS ANY OF THE NON-BIO-RAD WEBSITES LINKED TO THIS SITE, YOU DO SO ENTIRELY AT YOUR OWN RISK. Your input You are prohibited from posting or transmitting to or from this Site any material that is unlawful, threatening, libelous, defamatory, obscene, pornographic, or that otherwise violates anyone's rights. Bio-Rad retains the right to remove any messages including, but not limited to, any material that it deems abusive, defamatory, obscene, or otherwise unacceptable, unlawful or in violation of any third party s rights. Bio-Rad is not liable in any way for the content of messages posted by you or any other user, and such messages do not necessarily represent the ideas or opinions of Bio-Rad. You agree to indemnify and defend Bio-Rad from any third party liability incurred as the result of any material you have posted or transmitted from this website. Bio-Rad assumes no responsibility for reviewing unsolicited ideas for our business (like product or advertising ideas) and will not incur any liability as a result of any similarities between those unsolicited ideas and ideas that may appear in future Bio-Rad products and advertising. You agree that all rights to materials and ideas submitted by you to Bio-Rad may be used by Bio-Rad for any purpose without compensation to you. User registration To post, upload or download materials or data, communicate via and to access this site, Services, resources and certain or all Site content, User is asked to provide registration details and log on. It is a condition of use of this site, Services and Site content that all registration details User provides are and will remain true, correct, current and complete. You therefore agree to notify Bio-Rad immediately of any changes which are relevant to your registration. Log on/off Where you log on in order to gain access to this site or a part of this site, where Bio-Rad provides a 'log-off' option, you undertake to log off and exit from your account at the end of your session. Bio-Rad reserves the right to log off logged on Users whose accounts are inactive for an extended period of time. In order to preserve quality of service for all users as a whole Bio-Rad reserves the right to disconnect you from the Service if your connection to the Service is idle or in any event after 0 minutes. Passwords and account details User is responsible for maintaining the confidentiality of his or her password, account number, ID and other details (if any) and for all activities under User's account. Any unauthorized use of User's account or other breach of security should be reported to Bio-Rad immediately. Your registration and/or subscription is personal to you and you may not disclose or make available your account name, ID or password to others. Any disclosure by you of your account name and password may result in termination of your registration and/or subscription and, where you register for fee/subscription-based content/services, such termination shall be without refund. User content: uploaded or provided information/materials In these Terms, User content is information or other content, which is or may be provided to Bio-Rad or entered or uploaded by User via this site or related means, including (without limitation) interlaboratory data, proficiency test results, statistical derivatives, pictures, graphics, document or data files, texts, opinions, personalization settings and other information. By uploading User content to this site, pursuant to or by reason of site, Services or Site content use or otherwise, User automatically grants Bio-Rad, Bio-Rad Affiliates and their designees a perpetual, irrevocable, right and license to create, publish, translate, display and distribute de-identified, statistical derivative reports and data into any form or medium, including but not limited to interlaboratory reports and proficiency test reports. However, this section does not apply to any personal information submitted by a User which identifies him or her. Personal information Personal information will be processed in accordance with the Privacy Policy of this or related Bio-Rad websites, elsewhere in these Terms and any other terms and conditions which apply specifically to any relevant transaction (if any) between User and any Bio-Rad affiliate. Storage and loss of user content Bio-Rad shall not be liable for any loss, deletion, removal or failure of delivery to the intended Service of User content uploaded to this site, whether caused by computer virus, unauthorized access or otherwise. Users are encouraged to retain a back-up copy of all User content and Users undertake that they shall do so in respect of all uploaded User content. My einserts User Guide 3

26 Software downloads and online applications Any Licensed Software programs, services or utilities available for download or as a remote application or service, from the Site content are provided by way of support and service to Users. User's use of any downloaded Licensed Software programs shall be governed also by the terms of any associated on- or off- line documents, end user license or other relevant agreements, and terms and conditions specified by the relevant vendor or licensor (EULA) (which shall supersede these Terms, in the case of any inconsistency with these Terms). Applicable EULA's may impose additional warranty and liability exclusions or limitations on the software program. The downloading of any software program constitutes acceptance of these Terms. If you do not agree with these Terms, you may not download any software program or accompanying online documentation. Termination Bio-Rad may terminate User's access to or registration through this site if User's account is not accessed or if User does not log-on during any period of 6 months or more. In such circumstances, Bio-Rad will make attempt to send notice of termination to Users at their last notified contact address or address. Upon termination, Bio-Rad will retain User Content for a period of two years, or as deemed necessary to meet regulatory requirements. Restrictions on links If you would like to link to Bio-Rad's QCNet Site, you must comply with all applicable laws and the following guidelines: A website that links to Bio-Rad's My einserts website and QCNet website: may link to, but not replicate, My einserts website content or QCNet website content; should not create a browser or border environment around My einserts website content or QCNet website content; should not imply that Bio-Rad is endorsing it or its products; should not misrepresent its relationship with Bio-Rad; should not present false information about Bio-Rad products or services; should not use the BIO-RAD trademark or any other trademarks owned by Bio-Rad without permission from Bio-Rad; should not contain content that could be construed as distasteful, offensive, or controversial Indemnification You agree to indemnify, defend and hold Bio-Rad and its agents, officers, directors, employees, subcontractors, successors, assigns, third party suppliers of information and documents, product and service providers, and affiliates harmless from any liability, loss, claim and expense related to your violation of this Agreement or use of the Site. Limitation of liability Bio-Rad shall not be liable for any loss, injury, claim, liability, or damage of any kind resulting in any way from () any errors in or omissions from the Site or any services or products obtainable therefrom, () the unavailability or interruption of the Site or any features thereof, (3) your use of the Site, (4) the content contained on the Site, or (5) any delay or failure in performance. Severability In the event that any of the provisions herein shall be held by a court of competent jurisdiction to be unenforceable, the remaining provisions shall remain in full force and effect and shall be construed as a whole in such a manner as will carry out the purpose hereof and afford Bio-Rad the maximum protection of its business interests allowed by law. Applicable laws These terms of use shall be governed by and construed in accordance with the laws of the State of California, United States of America, without giving effect to any principles of conflicts of laws. However, to the extent that these terms of use conflict in any material way with any applicable law or regulation, such law or regulation shall control. You agree to comply with all applicable domestic and international laws, statutes, ordinances and regulations regarding your use of the Site and the Content and Materials provided therein. 4 My einserts User Guide

27 For further information, please contact your local Bio-Rad office or learn more online at Clinical Diagnostics Group Website U.S BIO-RAD Australia Austria Belgium Brazil Canada China Czech Republic Denmark Finland France Germany +49-(0) Greece Hong Kong Hungary India Israel Italy Japan Korea Mexico +5 (55) The Netherlands New Zealand Norway Poland Portugal Russia Singapore South Africa Spain Sweden Switzerland Thailand United Kingdom +44-(0) Bio-Rad Laboratories, Inc. / Q-80

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