Integrated eDiary Spirometer in Real-Time

PiKoLogic combines the accuracy of the award winning PiKo lung health monitor with advanced electronic diary capabilities into a single package revolutionizing the home-based component of clinical trials. Both measurement and diary data are instantly and securely transferred at prescribed testing times via cellular technology to nSpire Healths central server for quality review, data management, and sponsor access.

The Right Choice For your Clinical Trial PiKoLogic. Features and Benefits.
Automated alarms and reminders enhance patient compliance Non-compliant subjects are identified in real-time, enabling changes early in the study cycle, maximizing trial productivity Remote configuration speeds study start-up, simplifies protocol modification, and enables adaptive study techniques Real-time data transfer through secure cellular technology Proprietary branching logic permits decisions based upon actual lung function measurement from anywhere, at anytime FDA 21 CFR Part 11 compliance ensures more consistent, reliable, and secure data PiKoLogic captures real-time patient data directly from PiKo lung health monitors and transmits it wirelessly to nSpire Health clinical trials secured data repository, dramatically enhancing the collection, accuracy, and reliability of subject data. PiKoLogic manages study start up, simplifies home data collection, and acclerates time to data lock, shortening respiratory trials and reducing study costs.

The Right Choice For Subject Compliance

PiKoLogic makes gathering subjects day-to-day experiences simple and convenient. Following your defined clinical trial protocol is unequivocal and subject compliance is significantly increased with built-in alarms reminding subjects to input information. Timestamped entries and real-time messaging permit intervention in the event of poor subject compliance, preventing potential deenrollment or unnecessarily large subject sample size. PiKoLogics intuitive design uses large fonts and a bright color touch screen display for ease of use, making it an ideal solution for a broad range of subject populations.

Single Button Operation Magnetic Closure Color Touch Screen Data Transmission Indicators
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PiKo Monitor

USB Charger Connection

Inspiring Respiratory Health

The Right Choice Real-Time Data Collection

Test subjects are automatically alerted per protocol definition of the time to begin a testing / response session. Predefined response intervals allow subjects enough time to comfortably respond to the request while staying within protocol guidelines. PiKo clinical trial units are specially encoded to respond only to the PiKoLogic base unit. Each PiKos identity is linked to the subject and PiKoLogic, further enhancing confidence in data protection and security. Simplified touch screen interaction makes for quick data entry in one short test session. Missed entries can be easily corrected during the session, avoiding unnecessary edit checks.

The Right Choice An Integrated Solution

A truly integrated solution, PiKoLogic combines both eDiary and a PiKo lung health monitor into a single physical package. Unlike other electronic diaries that require separate transfer devices, PiKoLogic is a self contained design. Data transmission is built into the device and occurs automatically without any user intevention via the global celluar network. PiKoLogic data are compatible with nSpire Healths proprietary eSP software for managing clinical trials. eSP supports custom configuration, data collection, and reporting of trial data. Via eSP, PiKoLogic is instantly available to nSpire Healths professional services teams for Quality Assurance, Data Management, and sponsor reporting.

Immediately following a test session, subject data is available for automated transmission via the secured cellular network available in most locations worldwide. Compact data packets eliminate the need for expensive high speed connections, minimizing pass through costs.

The Right Choice Co

System Status

Login using secure PIN

Test Results

Yes or No Response

The Right Choice Easy Deployment & Support

PiKoLogic units are initialized at each study site for rapid deployment. Previously defined subject identity and appropriate protocols are encoded into each device and securely matched to the server data. Different protocols can be used in the same study, for example, to support different languages. On screen instruction simplifies clinical trial protocols, minimizing training requirements. Ambient recording conditions required for accurate spirometry is automatically monitored, eliminating the need for manual entry. Key PiKoLogic parameters with full data redundancy are monitored 24/7/365 ensuring that no clinical trial data is lost. If a PiKoLogic unit is replaced, test data and subject information is replicated without data loss or disruption to the study.

The Right Choice Protocol Design

Automatic or ad hoc messages can be sent to trial subjects via PiKoLogic. For example, a protocol can be configured to automatically send a notification when the subject has missed more than 2 questions or has produced insufficient test data. Message acknowledgments are transmitted via the nSpire Health server, creating a clear audit trail of subject interaction. Automated SMS text messages and emails can be sent when certain predefined criteria are met. Branching logic based upon test results (FEV1, FEV6, PEF, as compared to reference) provides protocol designers the freedom to create unique and effective decision criteria.

onsistent User Interface

Standard Settings

Advanced Settings

Scale Response

Multiple Choice

The Right Choice For Data Confidence and Compliance

Confidence in PiKoLogic performance is guaranteed through production within an ISO certified facility with exacting quality assurance standards and controls and through independent laboratory validation. PiKos performance and simplicity have been proven to deliver an error-free testing environment. Single-button operation, automatic quality checks, and automated data transfer are integrated into the PiKoLogic system. PiKoLogics extensive scenario-based branching structure selects questions based upon questionnaire responses, in addition to parameters and test results, increasing productivity and improving the clinical yield of subject testing. PiKoLogic is a comprehensive study and subject management solution that brings real-time access of valuable subject data to clinical trials, allowing trial leaders to make educated decisions throughout the trial process and intervene immediately if a problem occurs. PiKoLogics enhanced measurement capabilities collect data from subjects at home or while traveling, providing primary endpoint data for many studies, supplementing site-based spirometry data, and shortening study length with more accurate and reliable data points.

Technical Specifications
PiKo-1 Clinical
Sensor: Pressure/flow sensor (patented US #6,447,459 B1) Encryption: Proprietary Quality Factor: Warning & indicator for cough or abnormal blow Sounds: Four patterns for different indications and warnings Battery Life: One year typical (based on average of 6 blows per day) Battery Type: 2 x type 357 silver oxide button cells (or equivalent) Dimensions: 75 x 35 x 20 mm; 35 grams Resistance: <2.5 cmH2O/l/sec at 14 LPS or lower Operating Temperature: 10C to 38C (50F to 100F) Storage Temperature: -20C to 60C (-4F to 140F) Humidity: 0 - 100% relative humidity Barometric: 550 to 780 mm Hg Performance: ATS (1994 monitoring), ATS/ERS 2005 (diagnostic

accuracy and precision), AS/NZS-4237: 1994, EN13826: 2003

Safety: EN60601-1, 60601-1-1, 60601-1-2, and IPX4 Regulatory: FDA 510 (k) for OTC; CE (0086), Class I with measurement function Storage Capacity: 96 tests PEF: Range: 15 - 999 LPM (1 LPM resolution) Accuracy: 5% or + 20 LPM (whichever is greater) FEV1: Range: 0.15 - 9.99 liter (0.01 liter resolution) Accuracy: + 3.5% or 0.1 L (whichever is greater)

PiKoLogic

Included Items (not required for operation) Stylus, Magnifying Glass Language Support: English, French, Italian, German, Spanish Future Language Support: Based on clinical trial requirements Indicators: Low Battery, Charging, and Data Transmission Battery Charger: 90-264 VAC, 50-60Hz Dimensions: 7 x 3.75 x 1.375 inches Weight: 13.2 ounces Storage Temperature: -15.5 - 45 C Storage Humidity: 5% - 95% RH non- condensing Operation Temperature: 0-35 C Operation Humidity: 5% - 95% RH non- condensing Altitude: 10,000 ft (3048 meters) maximum Subject Security: Tamper proof enclosure; programmatically locked, up to 6 digit secured PIN number Regulatory: 21CRF Part 11, HIPAA, CMDCAS / Health Canada, CE Mark FCC: ED9LMX9838 Cellular Transmission: GPRS, GSM Supported Questionnaires: Juniper, St. George, CRQ, SRI

Contact Information
nSpire Health, Inc. 1830 Lefthand Circle Longmont, CO 80501 Tel. +1.303.666.5555 800.574.7374 nSpire Health Ltd. Unit 10 Harforde Court John Tate Road Hertford SG13 7NW, UK Tel. +44 (0) 1992 526300
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Web/Email. www.nspirehealth.com research@nspirehealth.com

Copyright nSpire Health 2009. eSP, nTegrity, eQuery, AccuTrax, HDpft, and iFlow are trademarks of nSpire Health. PiKoLogic, KoKo, PiKo, and ZAN are a registered trademarks of nSpire Health. Due to continual innovations, nSpire Health reserves the right to change specifications without notice.

PN 633099.A