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.
Single Button Operation Magnetic Closure Color Touch Screen Data Transmission Indicators
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PiKo Monitor
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.
System Status
Test Results
Yes or No Response
Standard Settings
Advanced Settings
Scale Response
Multiple Choice
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
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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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