YDVINTELLICAP-CIIntelliCap

© 2010 Koninklijke Philips Electronics N.V. IntelliCap User Manual page 2/49 Manual Philips Medimetrics Printed copies are uncontrolled unless authenticated Confidential. No disclosure of the contents to persons outside Philips Medimetrics is allowed without the written permission of Koninklijke Philips Electronics N.V. who is the owner of this information. iPS-100012 Date: 22 Nov 2010 Version: 2.0 Status: approved 24 25 26 27 IntelliCap Drug Delivery and 28 Monitoring System 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 Printed copies are uncontrolled unless authenticated © 2010 Koninklijke Philips Electronics N.V. IntelliCap User Manual page 3/49 Manual Philips Medimetrics Printed copies are uncontrolled unless authenticated Confidential. No disclosure of the contents to persons outside Philips Medimetrics is allowed without the written permission of Koninklijke Philips Electronics N.V. who is the owner of this information. iPS-100012 Date: 22 Nov 2010 Version: 2.0 Status: approved 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 User Manual 89 November 2010 90 91 92 © 2010 Koninklijke Philips Electronics N.V. IntelliCap User Manual page 4/49 Manual Philips Medimetrics Printed copies are uncontrolled unless authenticated Confidential. No disclosure of the contents to persons outside Philips Medimetrics is allowed without the written permission of Koninklijke Philips Electronics N.V. who is the owner of this information. iPS-100012 Date: 22 Nov 2010 Version: 2.0 Status: approved Table of Contents 93 1. General Information ....................................................................... 6 94 Trademarks ........................................................................................ 6 95 2. Software License Agreement ........................................................... 7 96 Software Licence Agreement ................................................................. 7 97 3. Intended Use ................................................................................ 8 98 4. Contraindications ........................................................................... 8 99 5. Restrictions ................................................................................... 9 100 6. Product Description ........................................................................ 9 101 7. IntelliCap System Components ...................................................... 13 102 7.1 Control Center PC ........................................................................ 13 103 Software .......................................................................................... 13 104 7.2 Start Up Unit ............................................................................... 14 105 7.3 Portable Unit ............................................................................... 15 106 Amber Module .................................................................................. 16 107 7.4 IntelliCap Capsule ........................................................................ 16 108 8. Data security and privacy ............................................................. 18 109 9. Warnings .................................................................................... 18 110 10. Cautions ..................................................................................... 19 111 11. Safety ........................................................................................ 19 112 11.1 Portable Unit Indicators ............................................................. 19 113 11.2 Control Center Indicators ........................................................... 19 114 12. Utilization of IntelliCap ................................................................. 21 115 13. Recovery and Disposal of the IntelliCap Capsule ............................... 22 116 14. Data Viewing Software ................................................................. 23 117 Starting the IntelliCap Software .......................................................... 23 118 15. Parts & Supplies .......................................................................... 25 119 16. Capsule Preparation ..................................................................... 26 120 17. Entering the pH Calibration Data .................................................... 27 121 18. IntelliCap Capsule Initialization ...................................................... 27 122 19. Pairing the Control Center to a PU .................................................. 30 123 © 2010 Koninklijke Philips Electronics N.V. IntelliCap User Manual page 5/49 Manual Philips Medimetrics Printed copies are uncontrolled unless authenticated Confidential. No disclosure of the contents to persons outside Philips Medimetrics is allowed without the written permission of Koninklijke Philips Electronics N.V. who is the owner of this information. iPS-100012 Date: 22 Nov 2010 Version: 2.0 Status: approved 20. Activating an IntelliCap Capsule ..................................................... 30 124 21. Pairing the Control Center to an IntelliCap Capsule ........................... 32 125 21.1 Manual Pairing of IntelliCap Capsule / Portable Unit / Control Center 32 126 21.2 Automatic Pairing on Activation ................................................... 33 127 22. Data Storage and Review .............................................................. 34 128 22.1 Changing the Data Log File ......................................................... 34 129 22.2 Exporting Current Data to an Excel File ........................................ 35 130 23. Commands to the IntelliCap Capsule .............................................. 35 131 23.1 Setting the Pill ID ...................................................................... 36 132 23.2 Shutdown an IntelliCap Capsule .................................................. 3…

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Regulatory Statement for FCC (FCC ID: YDVINTELLICAP-CI). FCC Information to User This product does not contain any user serviceable components and is to be used with approved antennas only. Any product changes or modifications will invalidate all applicable regulatory certifications and approvals FCC Guidelines for Human Exposure Pursuant to Part 2 of the FCC Rules, section 2.1093, this device is categorically excluded from routine environmental evaluation for RF exposure. FCC Electronic Emission Notices This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. FCC Radio Frequency Interference statement This equipment has been tested and found to comply with the limits for a class B device (all other receivers subject to Part 15), pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. Operation of this equipment in a residential area may cause harmful interference, in which case the user will be required to correct the interference at his own expense. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: . Reorient or relocate the receiving antenna . Increase the separation between the equipment and receiver . Connect the equipment into an outlet on a circuit different from that to which the receiver is connected . Consult the dealer or an experienced radio/TV technician for help

Photographs module 20103163304 External PHOTOGRAPH 1: - TEST SAMPLE OF 358ID220 ................................................................................................. 2 Page: 2 of 2 Report number: 20103163304 Photograph 1: - Test sample of 358iD220

Product Product combined with external battery, used for all testing Parts of the above setup (no liquid used at all)

© 2010 Koninklijke Philips Electronics N.V. Concept Label IntelliCap Capsule page 1/4 Philips Medimetrics Printed copies are uncontrolled unless authenticated Confidential. No disclosure of the contents to persons outside Philips Medimetrics is allowed without the written permission of Koninklijke Philips Electronics N.V. who is the owner of this information. iPS-090053 Date: 28 Apr 2011 Version: 4.0 Status: draft 1 2 3 4 5 6 7 8 9 Review & approval 10 Name Reviewer Function Reviewer Review date Signature Olaf Weiner CEO/GM Medimetrics Jeff Shimizu CTO/Director R&D Medimetrics 11 12 Name Approver Function Approver Approval date Signature Ventzeslav Iordanov Director QA&RA Medimetrics 13 14 Name Author Function Author Ventzeslav Iordanov Director QA&RA Medimetrics 15 © 2010 Koninklijke Philips Electronics N.V. Concept Label IntelliCap Capsule page 2/4 Philips Medimetrics Printed copies are uncontrolled unless authenticated Confidential. No disclosure of the contents to persons outside Philips Medimetrics is allowed without the written permission of Koninklijke Philips Electronics N.V. who is the owner of this information. iPS-090053 Date: 28 Apr 2011 Version: 4.0 Status: draft Table of Contents 16 1. Concept Label ......................................................................................................... 3 17 2. Annexes .................................................................................................................. 4 18 3. Document history .................................................................................................... 4 19 20 21 © 2010 Koninklijke Philips Electronics N.V. Concept Label IntelliCap Capsule page 3/4 Philips Medimetrics Printed copies are uncontrolled unless authenticated Confidential. No disclosure of the contents to persons outside Philips Medimetrics is allowed without the written permission of Koninklijke Philips Electronics N.V. who is the owner of this information. iPS-090053 Date: 28 Apr 2011 Version: 4.0 Status: draft 1. Concept Label 22 Manual label IntelliCap container carrier: 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 Note: 43 The IntelliCap serial number is formed by two numbers: the one on the electronic body + 44 the one on the medicine reservoir ring. Since the electronic body will directly be placed in the 45 container carrier it is proposed the container is labeled directly with the number on the 46 electronic body. The medicine ring number is additionally added (e.g. by hand writing) when 47 the reservoir attached. Detailed information on the numbering can be found in Annex 1. 48 Container label in real size: 49 50 51 52 53 54 55 56 57 IntelliCap Capsule iPSYYMXXXW Medimetrics MEDIMETRICS Personalized Drug Delivery HTC 34 (WB.2-043) 5656 AE Eindhoven, The Netherlands YYMXXX FCC ID: YDVINTELLICAP-CI 0344 0560 MMYYYY Property of Medimetrics IntelliCap Capsule iPSYYMXXXW Medimetrics YYMXXX FCC ID: YDVINTELLICAP-CI 0344 0560 MMYYYY Property of Medimetrics MEDIMETRICS Personalized Drug Delivery HTC 34 (WB.2-043) 5656 AE Eindhoven, The Netherlands +31 40 27 49268 The Netherlands +1 914 945 6628 USA This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. © 2010 Koninklijke Philips Electronics N.V. Concept Label IntelliCap Capsule page 4/4 Philips Medimetrics Printed copies are uncontrolled unless authenticated Confidential. No disclosure of the contents to persons outside Philips Medimetrics is allowed without the written permission of Koninklijke Philips Electronics N.V. who is the owner of this information. iPS-090053 Date: 28 Apr 2011 Version: 4.0 Status: draft 2. Annexes 58 Annex # Document title Document ID 1 Annex IntelliCap capsule label - laser engraving iPS-100213 59 3. Document history 60 Version Date Author Description of changes CR 0.1 2011-04-28 Ventzeslav Iordanov Proposed draft N/A 61 END OF DOCUMENT 62

Photographs module 20103163304 Internal PHOTOGRAPH 1: - OVERVIEW OF 358ID220 ..................................................................................................... 2 PHOTOGRAPH 2: - INTERNAL VIEW ON 358ID220 .............................................................................................. 3 Page: 2 of 3 Report number: 20103163304 Photograph 1: - Overview of 358iD220 Page: 3 of 3 Report number: 20103163304 Photograph 2: - Internal view on 358iD220

Radio test report 20103163304 - Rev. 1.0 based on: FCC part 15; subpart C; section 15.231e (10-1-09 edition) IntelliCap MediMetrics 358iD220 Report number: 20103163304 - Rev. 1.0 Contents MAIN MODULE .............................................................................................................................................. 3 1 ...... INTRODUCTION ...................................................................................................................................... 3 2 ...... PRODUCT ............................................................................................................................................... 4 3 ...... TEST SCHEDULE ..................................................................................................................................... 4 4 ...... PRODUCT DOCUMENTATION ................................................................................................................... 5 5 ...... OBSERVATIONS AND COMMENTS ........................................................................................................... 5 6 ...... MODIFICATIONS TO THE SAMPLE ............................................................................................................ 5 7 ...... SUMMARY.............................................................................................................................................. 5 8 ...... CONCLUSIONS ........................................................................................................................................ 6 TEST RESULTS MODULE ............................................................................................................................ 7 1 ...... EMISSION TESTS ..................................................................................................................................... 7 1.1 Field strength of radiated emissions of unintentional radiators ......................................................... 7 1.2 Field strength of radiated emissions of intentional radiators ........................................................... 11 1.3 Transmission time ........................................................................................................................... 19 1.4 Occupied bandwidth ....................................................................................................................... 21 USED TEST EQUIPMENT MODULE ........................................................................................................ 22 REVISION HISTORY ................................................................................................................................... 23 This report comprises of three modules. The total number of pages is: 23 Main module Page: 3 of 23 Report number: 20103163304 - Rev. 1.0 Main module 1 Introduction This report contains the result of tests performed by: Telefication B.V. Edisonstraat 12a 6902 PK Zevenaar The Netherlands Telefication complies with the accreditation criteria for test laboratories as laid down in ISO/IEC 17025:2005. The accreditation covers the quality system of the laboratory as well as the specific activities as described in the authorized annex bearing the accreditation number L021 and is granted on 30 November 1990 by the Dutch Council For Accreditation (RvA: Raad voor Accreditatie). The contents of this test report, if reproduced, shall be copied in full, unless special consent in writing for reproduction in part is granted by Telefication. Copyright of this test report is reserved to Telefication. Ordering party: Company name : Medimetrics Address : High Tech Campus 34 (WB2 053) Zipcode : 5656 AE City/town : Eindhoven Country : The Netherlands Date of order : 9 February 2010 Main module Page: 4 of 23 Report number: 20103163304 - Rev. 1.0 2 Product A sample of the following product was submitted for testing: Product description : Short Range Device Manufacturer : MediMetrics Trade mark : IntelliCap Type designation : 358iD220 FCC ID : YDVINTELLICAP-CI Hardware version : 2.0.2 Serial number : -- Software release : 2.0.2.2308 3 Test schedule Tests were carried out in accordance with the specification detailed in chapter 7 “Summary” of this report. Tests were carried out at the following location:  Telefication, Zevenaar The sample of the product was received on:  10 February 2010 Tests were carried out between the following dates:  10 February and 30 April 2010 Main module Page: 5 of 23 Report number: 20103163304 - Rev. 1.0 4 Product documentation For production of this report the following product documentation was used: Description: Date: Identification: Bill Of Materials 2010-04-14 iPill_BOM.pdf Circuit diagram 2010-04-14 iPill_circuit.pdf PCB layout 2010-04-14 iPill_flexPCB.pdf Technical file 2010-04-14 iPill_Mar2010_tech.pdf CommunicationProtocols 2010-04-14 iPS-090032 Communication Protocols.pdf The fore mentioned documentation would be filed at Telefication for a period of 10 years following the issue of this report. 5 Observations and comments In order to facilitate testing of fundamental and spurious emissions a sample modified for continuous transmitting was provided by the applicant. All other tests are performed with the (unmodified) automatically operating sample. Because the electrical capacity of the internal battery is very small, an external battery was attached to the sample. 6 Modifications to the sample No modifications were made to the sample. 7 Summary The product is intended for use in the following application area(s):  PART 15 DATA TRANSMISSION The sample was tested according to the following specification(s):  FCC part 15; subpart C; section 15.231e (10-1-09 edition) Main module Page: 6 of 23 Report number: 20103163304 - Rev. 1.0 8 Conclusions The sample of the product showed NO NON-COMPLIANCES to the specification stated in chapter 7 of this report. The results of the tests as stated in this …

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Photographs module 20103163304 Test set up PHOTOGRAPH 1: - TEST SETUP RADIATED EMISSIONS (30 - 1000 MHZ) .............................................................. 2 PHOTOGRAPH 2: - TEST SETUP RADIATED EMISSIONS (30 - 1000 MHZ) .............................................................. 3 PHOTOGRAPH 3: - TEST SETUP RADIATED EMISSIONS (1 - 5 GHZ) ...................................................................... 4 PHOTOGRAPH 4: - TEST SETUP RADIATED EMISSIONS (1 - 5 GHZ) ...................................................................... 5 Page: 2 of 5 Report number:20103163304 Photograph 1: - Test setup radiated emissions (30 - 1000 MHz) Page: 3 of 5 Report number:20103163304 Photograph 2: - Test setup radiated emissions (30 - 1000 MHz) Page: 4 of 5 Report number:20103163304 Photograph 3: - Test setup radiated emissions (1 - 5 GHz) Page: 5 of 5 Report number:20103163304 Photograph 4: - Test setup radiated emissions (1 - 5 GHz)

Product Product combined with external battery, used for all testing Parts of the above setup (no liquid used at all)