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DiaCeph Test Non-Invasive Monitoring System for Hydrocephalus Stand-alone Device ------- Mobile Phone App

2 DiaCeph Test. Introduction. The DiaCeph Test is a stand-alone device and mobile phone app for use by patients, families, and medical staff to non-invasively track CNS shunt performance and outcomes in persons treated for hydrocephalus. The current standard is CT and MRI exams. Hydrocephalus, a co

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DiaCeph Test Non-Invasive Monitoring System for Hydrocephalus Stand-alone Device ------- Mobile Phone App

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    1. DiaCeph Test Non-Invasive Monitoring System for Hydrocephalus Stand-alone Device ------- Mobile Phone App By: Stephen Dolle www.DolleCommunications.com U.S. Patent No. 6,241,660 June, 2001 Updated: August 2009 1 DiaCeph Test

    2. 2 DiaCeph Test Introduction The DiaCeph Test is a stand-alone device and mobile phone app for use by patients, families, and medical staff to non-invasively track CNS shunt performance and outcomes in persons treated for hydrocephalus. The current standard is CT and MRI exams. Hydrocephalus, a condition involving excess cerebral spinal fluid (CSF) in the brain, often requires a CNS shunt to divert excess CSF. Shunt use faces key challenges in evaluating when a shunt may be in malfunction, and if one is properly matched and/or programmed for a patient. This app would be more sensitive and useful than CT or MRI alone. As a mobile phone app, it could be widely made available for iPhone, Blackberry, and Windows Mobile OS. As a stand-alone device, it would include more detailed monitoring. Its routine use would improve treatment outcomes, quality of life, and reduce costs and risks associated with hydrocephalus.

    3. 3 DiaCeph Test Presentation Contents Slide 4 DiaCeph’s Core Technology Slide 5 Applications and Utilization Slide 6 DiaCeph Test Parameters Slide 7 DiaCeph Processing Features Slide 8 DiaCeph Test Results (Dual) Slides 9-21 Two Patient Histories and Test Results (with tables, graphs, and discussion) Slide 22 New In-Office ICP Tandem Application

    4. 4 DiaCeph Test Core Technology Stand Alone Device to Interface w/ PCs and Internet Mobile Phone App for iPhone, Blackberry, and Windows Mobile Phones Track Key Clinical Indicators in Real Time Processor Generates Approx ICP Values Measure Outcomes over Time Match Results to 14 Outcomes/Poss Malfunctions Standardized Means of Patient Education

    5. 5 DiaCeph Test Applications and Utilization 1. Any Time Monitoring of Shunt Performance by Patients, Family, Care Givers, and Medical Staff 2. Patient Education and Staff Training 3. Discharge Monitoring Post Shunt and ETV Procedures 4. Tandem Use with In-Office ICP Measurements 5. Precise Pressure Settings w/ Programmable Shunts 6. Pre-Surgical Evaluations of NPH 7. Support R&D and Trials of New Shunt Systems 8. Improve QA in Outcomes Assessment/Reporting

    6. 6 DiaCeph Test DiaCeph Test Parameters Activity: At Waking Rest Activities Tasking Playing/Out About Physical Activities Headache 0 1 2 3 Nausea 0 1 2 3 Malaise/Balance/* 0 1 2 3 Cognitive Test 0 1 2 3 Posture Test(ICP) - + N/C Indeter. 7. Proximal Refill -2 -1 0 +1 +2 8. Proximal Visual -Swell/Pain +Swell/Pain +Swell 9. Distal Visual -Swell/Pain +Swell/Pain +Swell 10. Interventions Testing ? ? NC Indeter. *May be Substituted in System Default Settings

    7. 7 DiaCeph Test Processing Features 1. Creates an ICP Value: Nausea, Headache, Malaise/ Balance, Cognitive, and Postural Test are matched as weighted data sets to ICP Values between –3 and +3, where Postural Tests and Interventions determine “-” or “+” of the value. Outcome/Malfunction Analysis: Data sets matched here with ICP Values and Activity to 14 possible Outcomes/Types of Malfunction. Multiple matches possible. Non-matching data due to “erroneous collection techniques” are nullified here. Interventions are used to confirm/void inconclusive results. 3. Data Display Graphs: Data transferred over to PC program, generates/plots ICP Values and parameters vs. Time vs. earlier DiaCeph or base data. Results print from PC, and compare to In-Office ICP data, clinical exam, CT/MRI, Isotope Clearance.

    8. 8 DiaCeph Test DiaCeph Test Results Diagnosis: Data are Matched to Possible Outcomes/ Types of Shunt Malfunction below: A. Prox. Catheter Obstruction H. ASD/SCD Overfunction B. Prox. Obstr./Collapsed Vent I. Distal Cath./Valve Obstr. C. Prox. Disconnection J. Distal Catheter Mal-position D. Prox. Obstr. w/ Infection K. Distal Disconnection E. Normal Shunt Function L. Distal Obstr. w/Infection F. Shunt Underdrainage M. Other Pathology/Seizures G. Shunt Overdrainage N. Uncompensated Hydro. 2. Graphs: ICP Values/Ea. Parameter Data vs. Time vs. Earlier DiaCeph or Baseline Data

    9. 9 DiaCeph Test Patient #1: History and Treatment Patient #1 is a 16 yr-old female first shunted 4 months ago with a programmable shunt. The initial pressure was set at 100 cm H2O. After complaining of HA thought possibly related to high pressure, the shunt was adjusted down to 70 cm H2O and DiaCeph monitoring was ordered. Monitoring was performed at these set times: 7am, 10am, 12pm, 3pm, 6pm, and 9pm during the week of 8/13/01. See Data Table for 8/17/01.

    10. 10 DiaCeph Test Data Table 8/17/01: Setting=70cmH2O

    11. 11 DiaCeph Test Status Post 8/17/01: Setting=70cm H2O 1. The 8/17/01 Data Table reveals near normal ICP Value upon waking, with low ICP Values through the morning and afternoon, with upright posture. Shunt patency (Proximal Refill) reported as normal. DiaCeph processor matched Data with Shunt Overdrainage. In-office ICP reading revealed -5 cm H20 sitting, 15 cm H20 supine, concurring with DiaCeph Data and verified collection technique. 2. Valve setting was then raised to 110 cm H2O, and monitoring was performed again at the same times. See 9/14/01 Data Table and comparison Graph.

    12. 12 DiaCeph Test Data Table 9/14/01: Setting=110cmH2O

    13. 13 DiaCeph Test Patient #1: Graph 8/17/01 vs. 9/14/01 ICP Values/Proximal Refill vs. Time

    14. 14 DiaCeph Test Status Post 9/14/01: Implanting of Anti-Siphoning Device The 9/14/01 Data Table and program reported continued daytime Shunt Overdrainage, yet raised ICP Values upon waking finds Shunt Underdrainage - suggesting the 110 cm H2O setting was slightly too high. In light of this persistent overdrainage, she was fitted with a siphon control device (SCD), and the shunt pressure was set down to 100 cm H20. After the above, her c/o were improved and DiaCeph monitoring confirm improved data. See following Data Table, plus Graph on 9/24/01.

    15. 15 DiaCeph Test Data Table 9/24/01: Setting=100 w/ ASD

    16. 16 DiaCeph Test Patient #1: Graph 8/17/01 and 9/14/01, 9/24/01 (w/ SCD): ICP Values vs. Time

    17. 17 DiaCeph Test Patient #2: History and Treatment 1. Patient #2 is an 8 yr-old male shunted 4 years with a standard DP medium pressure shunt. He has been complaining of intermittent headache, nausea, and difficulty at school of a 4 week duration. Neurological exam and MRI were unremarkable. 2. DiaCeph monitoring was ordered and conducted by mother for one week at set times of: 7am, 12pm, 3pm, 6pm, and 8pm (12pm lunch@home), for the week beginning on 9/10/01. See Data Tables and comparison Graph of 9/10/01 and 9/13/01 in Slide 20.

    18. 18 DiaCeph Test Patient #2: Data Table 9/10/01

    19. 19 DiaCeph Test Patient #2: Data Table 9/13/01

    20. 20 DiaCeph Test Patient # 2: Graph 9/10/01 vs. 9/13/01 ICP Values/Proximal Refill vs. Time

    21. 21 DiaCeph Test Patient #2: Status Post 9/10-9/14 Monitoring 1. The 9/10/01 Data Table reveals slightly elevated ICP (+1) upon waking, which the program matched with Shunt Underdrainage. The ICP Values and program found Normal Shunt Function the remainder of the day. 2. The 9/13/01 Data Table reveals a more dramatic a.m. rise in ICP (+2), with an abnormal Proximal Refill (-1) value, seen somewhat consistent throughout the day. The program matched this data to Proximal Obstruction (A and B). The (-1) Proximal Refill and (+2) ICP correlate on the Graph. 3. In-Office ICP Tap 9/14/01 revealed 70 cm H20 supine, 25 cm H20 upright, verifying DiaCeph data and mother’s technique. An isotope clearance exam also concurred. The patient’s proximal catheter and shunt were revised, and he improved.

    22. 22 DiaCeph Test In-Office ICP Measurement to Corroborate Accurate use of DiaCeph We suggest NSGs obtain a “single” in-office ICP measurement via a manometer in tandem, for “best use” of the DiaCeph Test. When obtained during the same day/time as DiaCeph data, ICP tap readings in the upright and supine postures verify/raise test accuracy and correct use of DiaCeph system via matching ICP tap results to recorded points on DiaCeph Graphs.

    23. 23 DiaCeph Test End of Presentation If interested for more information contact: Stephen Dolle 3908 ½ River Ave. Newport Beach, CA 92663 Tel. (949) 642-4592 hydroinfo@dollecommunications.com www.dollecommunications.com

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