1 of 5 27-08-2013 01:20 PM Welcome to the SmartCode Report Generator This is a simple online application that helps you 'decode' the DeVilbiss SmartCode and generate sleep therapy data reports for patients. SmartCode Availability and Overview Availability SmartCode is currently available for Standard (DV51), Standard (DV53), AutoAdjust (DV54), Bilevel (DV55/56), and AutoBilevel (DV57). The most recent firmware update released on 01/21/2009 includes enhanced SmartCode features for both the Standard and AutoAdjust models. Units that were shipped prior to this release date can be upgraded in the field with a firmware update. For more information on the firmware update, please visit the following page: http://www.devilbisshealthcare.com/tech-corner/firmware-updates SmartCodes and Timeframes - Standard Plus, AutoAdjust, Bilevel, and AutoBilevel There are five SmartCodes available for Standard Plus, AutoAdjust, AutoBilevel, and Bilevel, each representing a 'rolling window' of usage based on different time frames: 1-day: provides data for the last day of usage 7-day: provides a summary of the past 7 days of usage 30-day: provides a summary of the last 30 days of usage 90-day: provides a summary of the last 90 days of usage SmartCode Usage: provides cumulative data since the start of therapy SmartCodes and Timeframes - Standard There are two codes available for Standard, one code that includes data for the 1, 7, 30 and 90-day timeframes, as well as one cumulative code. SmartCode: provides a summary of the past 1, 7, 30, and 90-day timeframes SmartCode Usage: provides cumulative data since the start of therapy Generating Reports with the Report Generator To use this report generator, you must first contact the patient and ask them to retrieve the SmartCode from their DV51, DV53, DV54, DV55/56 or DV57 CPAP. Simply call the patient and ask them to to turn on their device and press the left arrow once. Once you have collected the desired code(s) they can be de-coded using this report generator. Most of the information in the report generator is optional -- use it only if you want the information to display on the final report. A note about serial numbers: you can optionally include the device serial number in the patient's report. If you include a serial number, the SmartCode report generator will validate the collected codes to make sure that they match the device that the patient has. Once you have completed all of the desired fields and included at least one SmartCode, you click on 'generate report' to display the report. From there, you will be able to save the report as a PDF on your hard drive and distribute it. A note about privacy: The SmartCode report
2 of 5 27-08-2013 01:20 PM generator does not store any information about the patient. Once the report is generated, the only way to save information is to save it locally as a PDF. Sample Codes If you would like to take the SmartCode Report Generator for a test drive, please feel free to use the following sample codes: AutoAdjust Codes Serial Number: HD000005 1 Day: F6CD-39F-3570 7-Day: 3CCC-379D-7D75 30-Day DXY4-3D97-DJ7Y 90-Day: 7MTJT-47D9-7DT7L SmartCode Usage: ZD7-79FK-K7X Bilevel Codes Serial Number: LD000000 1 Day: 46MQ-39F-3AAF 7-Day: ACCP-979D-73AP 30-Day 5XYW-AD97-D6A6 90-Day: H82JT-L1D9-7DRAB SmartCode Usage: ZD7-79FK-KA6 Standard Codes Serial Number: ID000005 SmartCode: 16J-TCX8-2FL SmartCode Usage: ZD7-79FK-KFJ Standard Plus Codes Serial Number: JA000005 1 Day: FJ4F-3B3-3P2Q 7-Day: 3CCC-379D-7C20 30-Day D0Y4-3D97-DP2L 90-Day: 7MTJT-4594-7DV2P SmartCode Usage: ZD3-79FK-K2V AutoBilevel Codes Serial Number: MD000005 1 Day: B6CD-39F-35M1 7-Day: 9CCC-379D-7DM3 30-Day EXY4-3D97-DJMN 90-Day: CMTJT-47D9-7DTM4 SmartCode Usage: ZD7-79FK-KMJ SmartCode Report Definitions Minimum Use Threshold Determines the minimum amount of time that the patient must use the device to be logged as a compliant day. Device settings allow for 4 or 5 hours, with 4 hours being the default setting. This
3 of 5 27-08-2013 01:20 PM setting can be changed in the device clinical set-up menu. Adherence Score Shows the maximum adherence achieved for any period of thirty consecutive days of use within a ninety-day time frame. The score represents the percentage of days, within thirty consecutive days, where usage met or exceeded the Usage Threshold. This reports the best consecutive thirty days of usage. For example, if the best 30 out of the last 90 days show 22 days used above the usage threshold and 8 days below the threshold, then the Adherence Score would show 73% (22/30). For this calculation, the usage must be continuous hours and longer than the Usage Threshold. Days at Least X Hours Shows the number of days in the timeframe where the total usage within each day is at least X hours. X represents the Usage Threshold setting in the patient s device. For this calculation, all usage within a 24-hour period is recorded. % Days at Least X Hours Shows the percentage of days in the timeframe where the total usage within each day is at least X hours. X represents the Usage Threshold setting in the patient s device. For this calculation, all usage within a 24-hour period is recorded. Day Count Shows a count of days for each timeframe. If, for example, the 90-day code is collected at day 45 of therapy. The Day Count for this code will be 45 days. In most cases, however, the day count is equal to the days in the code s timeframe(s). While Breathing Hours While breathing hours are only available within the last-day timeframe and with the cumulative code. This measurement shows the total hours of use. 95th Percentile Pressure AutoAdjust or AutoBilevel pressure was at or below this pressure 95-percent of the time it is in use. 90th Percentile Pressure AutoAdjust or AutoBilevel pressure was at or below this pressure 90-percent of the time it is in use. AHI Apnea/Hypopnea Index (AHI) represents the average number of apneas and hypopneas per hour for the timeframe. Pressure Plateau Time Represents the percentage of time the AutoAdjust or AutoBilevel spent at the upper pressure setting. A value of 10% or more indicates a possible need to raise the upper pressure setting to allow higher pressures. High Leak Flow Time Shows the percentage of time where leak was above 95 liters per minute. A value of 10% or more indicates that the mask fit should be checked. NRI Non-Responding Event Index (NRI) represents the average number of non-responding events per hour.
4 of 5 27-08-2013 01:20 PM A non-responding event is a respiratory event that is detected but by design does not result in a pressure change during AutoAdjust or AutoBilevel therapy. EPI The Exhale Puff Index (EPI) is the number of exhale puff events detected per hour. Exhale puffing is caused by inhaling through the patient circuit and exhaling through the mouth. % Machine Inspiration % Machine Inspiration indicates the percentage of breaths in which the timed backup feature of the Bilevel ST has initiated an inspiration trigger. % Machine Expiration % Machine Expiration indicates the percentage of breaths in which the timed backup feature of the Bilevel ST has initiated an expiration cycle. How SmartCode Supports HIPAA Compliance Confidentiality HIPAA Security Rule (Electronic Protected Health Information) Authentication Authentication: Verify person / entity has access to electronic protected health information is the one claimed Access Control Automatic logoff: Terminate an electronic session after a predetermined time of inactivity Encryption and decryption: Encrypt/decrypt electronic protected health information How SmartCode Supports Compliance Unique administrator IDs All administrator passwords are encrypted Administrator password protocol in place Administrative SoD (Separation of Duties) with multiple levels of access control and administrator privileges Administrators cannot access accounts of other administrators All temporary files are purged after a short time period an encrypted Secure Socket Layer (SSL) connection Privacy Standard: Transmission Security Encryption: Encrypt electronic protected health information (that is being transmitted) an encrypted SSL connection
5 of 5 27-08-2013 01:20 PM Integrity Availability Audit Integrity: Protect electronic health information from improper alteration or destruction Implementation specifications: Mechanism to authenticate electronic protected information Integrity controls: Ensure that electronically transmitted data is protected 164.308 Administrative Safeguards Data backup plan: Establish and implement procedures to create and maintain retrievable exact copies of electronic protected health information Disaster recovery plan: Establish (and implement as needed) procedures to restore any loss of data Audit controls: Implement hardware, software, and/or procedural mechanisms that record and examine activity in information systems that contain or use electronic protected health information 164.308 Administrative Safeguards Log-in monitoring: Procedures for monitoring log-in attempts and reporting discrepancies All SmartCodes are protected by built in integrity checks All access to the system is captured in detailed logs and is monitored Physical access to hardware is restricted an encrypted SSL connection Data exists for a session. Data is not retained to protect privacy Hardware is monitored to ensure service availability Web browser access logging Logs are protected Detailed reporting is available of all system activity