Version 5.7. New Login Screen 2 Alere RALS -Manual Test Entry (MTE) 3. Alere HemoPoint H2 Meter 4 Piccolo Xpress Analyzer 5

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1 Release Summary for Alere RALS System Contents New Alere RALS System Features Version 5.7 New Login Screen 2 Alere RALS -Manual Test Entry (MTE) 3 New Devices Supported Alere HemoPoint H2 Meter 4 Piccolo Xpress Analyzer 5 Alere RALS System Updates Device and System Updates 6 Alere RALS System Fixes Miscellaneous System Fixes 7 Page Alere. All rights reserved. The Alere Logo, Alere, Acceava, BinaxNow, Clearview, Determine, RALS and Triage are trademarks of the Alere group of companies. All other trademarks referenced are trademarks of their respective owners. AI-DSREL0208 v3.0 Page 1 of 7 November 30, 2015

2 New Alere RALS System Feature(s) New Login Page: The system has now been updated to display a User ID and Password login-only page when first accessing the Alere RALS system website (see below). Remember, in Alere RALS System Version 5.6 we introduced new security options for users that want to take advantage of additional password requirements. For more on our new Password Security features including a list of optional settings, refer to our Version 5.6 release notes available at Release_Notes.htm. The following are required changes with an upgrade to version 5.6 and higher: The password can no longer include password The password can no longer be same as operator ID The password cannot contain first or last name The new settings apply to new users that need passwords and when changing an existing password. AI-DSREL0208 v3.0 Page 2 of 7 November 30, 2015

3 Alere RALS - Manual Test Entry (MTE) Alere RALS-MTE is a feature that enables you to enter manual or lateral-flow test results directly into an Alere RALS system and then send them to your LIS. Manual tests are configured using the pre-existing Manual Test Setup page and results can be directly entered through the Enter Manual Result Page. This means all tests done at the point-of-care can now reside in the Alere RALS database for viewing, reporting and more! As shown below, Alere RALS-MTE supports a wide range of test types. Acceava H. pylori Acceava Mono Cassette Acceava Mono II Test Acceava Strep A Dipstick Alere BinaxNow Influenza A&B Alere BinaxNow Legionella Urinary Antigen Card Alere BinaxNow RSV Card Alere BinaxNow S. pneumoniae Antigen Card Alere Determine HIV-1/2 Ag/Ab Combo Alere hcg Cassette 20 miu/ml Alere hcg Cassette 25 miu/ml Alere hcg Combo Cassette 20/10 miu/ml Alere hcg Combo Cassette 25 Alere hcg Dipstick Alere Influenza A&B Test miu/ml Alere PBP2a Culture Colony test BinaxNow Malaria BinaxNow S. aureus BinaxNow Strep A C. DIFF QUIK CHEK COMPLETE C. DIFF QUIK CHEK C. difficile C. DIFFICILE TOX A/B II Clearview COMPLETE HIV ½ Clearview H. pylori Clearview Mono Clearview RSV Clearview Strep A Exact II Fecal Occult Gastric Occult Dipstick Giardia/Crypto GIARDIA/CRYPTOSPORDIUM HIV QUIK CHEK IBD EZ VUE Influenza Lactoferrin Legionella LEUKO EZ VUE Malaria Mono MRSA PAMG-1 ph Hydrion ph Nitrazine Pregnancy Rapid DAT Rapid RSV Rapid Strep Rapid Urease S. Pneumoniae Shiga Toxin SHIGA TOXIN QUIK CHEK SpO2 Strep A tbili Urinalysis Visual UA Urine Refractometer AI-DSREL0208 v3.0 Page 3 of 7 November 30, 2015

4 New Devices Supported Alere HemoPoint H2 Meter Summary: The Alere HemoPoint H2 is a uni-directional device that connects to the Alere RALS system through RRC or Dataport. The device measures hemoglobin levels and calculates hematocrit level results using capillary, venous or arterial blood samples. It is a portable device that measures and stores patient and QC data. The Alere HemoPoint H2 meter delivers accurate results for hemoglobin and an estimated hematocrit level in less than a minute using only a single drop of blood by utilizing advanced microcuvette technology. Types of Tests the Device Performs: Patient Test, QC Test, and Proficiency Supported Features: Communication: Available Reports: Uni-directional Communication Data sent to Alere RALS System Anomalous Results by Device Alere RALS-eQuiz (if Patient test results Anomalous Results by Operator applicable) QC test results Comment Code Results Patient, Management Proficiency test results Institution Statistics QC Management Operator ID LIS Statistics by Proficiency Management Date/Time LIS Statistics by Operator Operator Management Operator ID Compliance by Certification Management Results Sent to Operator Pending EMR / EHR / LIS How the Device Connects Recertification Date Reports Alere RALS Remote Connect Operator Statistics Edit Logs (RRC) Operator Proficiency Test Material Management Alere RALS Dataport Patient ID Compliance by Evaluation Criteria Settings Operator Patient ID Compliance by Patient Results by Patient Results by Operator Patient Results by Patient QC Test Results Device Statistics Summary Levey-Jennings Comment Code Utilization Corrective Action Compliance by and by Operator Patient Result Comments Comment Codes Test Materials Workload Summary AI-DSREL0208 v3.0 Page 4 of 7 November 30, 2015

5 Piccolo Xpress Chemistry Analyzer Summary: The Piccolo Xpress Chemistry Analyzer is a uni-directional device that connects to the Alere RALS system through RRC and direct network connectivity. The device measures 31 blood chemistry tests that range from liver, kidney and metabolic functions to lipids, electrolytes and other specialty analytes using whole blood, serum or plasma samples. It is a portable tabletop device that measures and stores patient and QC data. The device uses a disposable selfcontained disc. The Piccolo Xpress Chemistry Analyzer s 12-minute test time, eliminates visual inspection and waiting for results. Types of Tests the Device Performs: Patient Tests, QC Tests, Proficiency, iqc Supported Features: Communication: Available Reports: Uni-directional Communication Data sent from Device Anomalous Results by Device Alere RALS-eQuiz (if Patient test results Anomalous Results by Operator applicable) QC test results Comment Code Results Patient Management Operator ID Institution Statistics QC Management Date/Time LIS Statistics by Operator Management LIS Statistics by Operator Certification Management Operator ID Compliance by Device Management How the Device Connects Results Sent to Alere RALS Remote Connect Operator Pending EMR / EHR / LIS (RRC) Recertification Date Reports Direct Network Operator Statistics Edit Logs Operator Proficiency Results Management Patient ID Compliance by Test Material Management Operator Evaluation Criteria Settings Patient ID Compliance by Patient Results by Patient Results by Operator Patient Results by Patient QC Test Results Device Statistics Summary Levey-Jennings Comment Code Utilization Corrective Action Compliance by Corrective Action Compliance by Operator Patient Result Comments Comment Codes Test Materials Workload Summary AI-DSREL0208 v3.0 Page 5 of 7 November 30, 2015

6 Alere RALS System Updates Alere i now supports Strep A assay Alere Triage meter now supports the following commands from RALS Sync Device Send All results Siemens DCA Vantage Analyzer now sends the Operator ID to the device to be used as the Access Code so that users can use their Operator ID when entering their Access Code on the device Siemens Stratus CS Diagnostic System QC results are now evaluated automatically and will no longer appear on the Results Management Page Nova StatStrip GLU now supports wireless configuration and communication with RALS Roche Accu-Chek Inform II now supports additional barcode configuration options with Firmware version Device Configuration Page was Re-designed for consistency across all supported device types: Page now contains Refresh, Add, Edit, Delete, Copy, and Assign s action buttons; Prior to version 5.7 the Copy button was used to assign (copy) the configuration to locations; In version 5.7, the Copy button is only used to copy the configuration to another configuration Navigation Tree now mirrors the Evaluation Criteria page format After upgrading to version 5.7, all old Configurations will now be listed as locations that are assigned to Saved Configurations. Device Configurations assigned in 5.7 are the same configurations assigned in prior versions, but displayed differently. If the location configuration matched an old saved configuration, then the location name will fall under the umbrella of that saved configuration. If the location configuration did not match any of the old saved configurations, then a new Saved Configuration is created for those settings, and called Unknown 1, with the location listed under that umbrella, plus any other locations that used the same settings. Example: A pre-5.7 system had 3 Saved Configurations: Adult, Baby, and ED, and 10 Configurations: s 1-5 were using the Adult configuration; NICU and Nursery were using the Baby configuration; ED1 and ED2 were using the ED configuration; and location 10 was not using any of the saved configurations. How it would look prior to v 5.7: How it will look after upgrading to v 5.7: A new equiz page Assigned Quizzes has been created in RALS replacing the legacy equiz Summary popup screen AI-DSREL0208 v3.0 Page 6 of 7 November 30, 2015

7 Alere RALS System Fixes Alere RALS connectivity no longer accepts entry of lower case characters for Sig Elite Lot # Alere RALS connectivity now displays the range status indicator for specific results in the grid. Previously, the system was displaying the range status indicator against the average across all result for the linearity level. Alere RALS connectivity is now properly sending the "Retain patient ID between samples" and Allow retention of test data for incomplete tests settings to the epoc device The epoc Hypoxic Lot # format in the Alere RALS system now matches package insert format allowing the system to recognize results as Hypoxic Alere RALS connectivity now receives and displays order field 14 from the Roche Cobas b 221(Relevant Clinical Information field). The Order Number for a result will be display in the Accession Number field Alere RALS connectivity now only performs password validation checks when a password has changed. Previously, the system was validating password requirements on any operator edit Alere RALS connectivity now supports the Profile Add/Edit dialog for i-stat, hcg as a Non-Measured value. Previously all BhCG cartridge results were being flagged for No Value, No Profile" Alere RALS connectivity is now properly displaying a column for BhCG within the i-stat Reagent Usage Report AI-DSREL0208 v3.0 Page 7 of 7 November 30, 2015