S6C102552Secure Methadone Delivery Technology Device

Date 22/09/05 Telecommunication Certification Body RFI Global Services Ltd. Pavilion A Ashwood Park Basingstoke Hampshire RG23 8BG United Kingdom Subject: Certification Application FCC ID: SC6102552 It is requested that the following information is to be held confidential on behalf of Applicants Name. FCC Rules Part 0.459 refers. The GSM Controller is part of a drug delivery system intended to be used to authenticate the dispensing of potentially fatal drugs such as Methadone, hydromorphone, Oxycodone and other drugs of addiction. Given that the patient population that use and abuse these drugs are very resourceful a select few will have technical ability and will try and abuse and compromise the GSM Controller. It is therefore imperative that as little technical information is made available to the public. A breach of information confidentiality may provide a potential hacker or other to compromise the system which may result in overdose or death for a wider population of users. Operational Description, 2 Files: ‘EP007_FRS_102257 GSM Controller Circuit Description’ 16 Pages ‘Q2426SK OpDes’ 9 Pages Commercially sensitive information which if made public may provide future competition with an advantage. The operation description reveals mechanisms used to store and retrieve cryptographic information. If this information was revealed it may pose harm to the integrity of the system as a whole. This information has not been made available to the public and should not be made public indefinitely for the reasons given above. Block Diagram s, 2 Files: ‘Block Diagram’ 1 Page ‘Q2426SK BlkDia’ 9 Pages Commercially sensitive information, Block Diagram reveals philosophy of the design. This information has not been made available to the public and should not be made public indefinitely for the reasons given above. Schematics, 2 Files: ‘EP007_DWG_101137 GSM Controller Schematics REV3’ 10 Pages ‘Q2426SK Schem’ 5 Pages Commercially sensitive information which may allow potential hackers to compromise the system. This information has not been made available to the public and should not be made public indefinitely for the reasons given above. Parts Lists / Tune-up information, 3 Files: ‘EP007_DWG_102554 US GSM CONTROLLER REV 3 BOM’ 3 Pages ‘Q2426SK PartsLst’ 5 Pages ‘Q2426SK TunPro’ 5 Pages This information would be of benefit to competitors and that the disclosure of the information in these documents would give competitors an unfair advantage in the market place. This information has not been made available to the public and should not be made public indefinitely for the reasons given above. Yours sincerely Rajiv Dave

Copyright and Designright PDD Lt d. - London www .pdd.co.uk Product Innovation Consultants SECURE KEY REF 101766 SN: 101766-xx-2005 GW Pharma Lt d !! 0086 LS101604/1.1 i !! I DATE FILE NAMELOCA TION 21 /0 9 /05 2938_UserEvalLabels_1 10405.cdr I:\!PDDWORK\JOBS\GW Pharma\2938_MDS\creative\working\coreldraw\labels CLIENTJOB No. ISSUE JOB GW PharmaceuticalsJ2938 GW Pharma Lt d SP4 0JQ UK WARNING: Only to be used with GW drug delivery systems GSM CONTROLLER REF 101763 SN: 101763-xx-2005 Use only with GW power supply REF 101765 provided Input . 6V 800mA Secure Key REF 101766 Port LS101607/1.1 !! 0086 i WARNING: Only to be used with applicable GW controller LS101603/1.1 SECURE METHADONE CANISTER REF 101764 SN: 101764-xx-2005 GW Pharma Lt d SP4 0JQ UK 0086 !! i POWER SUPPL Y SN: 101765-xx-2005GW Pharma Lt d Input: 100-240V ~50Hz/60Hz/0.15A Output: 6V 800mA LS101606/1.1 ii 0086 GW Pharma Lt d SP4 0JQ UK WARNING: Only to be used with GW drug delivery systems GSM CONTROLLER REF 102552 SN: 102552-xx-2005 Use only with GW power supply provided Input . 6V 800mA Secure Key REF 101766 Port LS102553/1 !! FCC ID S6C102552 European V ersion US V ersion Contains FCC ID CWTUGPZ2 GW Pharma Lt d SP4 0JQ UK WARNING: Only to be used with GW drug delivery systems GSM CONTROLLER REF 102552 SN: 102552-xx-2005 Use only with GW power supply provided Input . 6V 800mA Secure Key REF 101766 Port LS102553/1 !! FCC ID S6C102552 CLIENT A JOB No. DA TE FILE NAMELOCA TION ISSUE JOB Copyright and Designright PDD Lt d. - London www .pdd.co.uk Product Innovation Consultants SECURE KEY REF 101766 SN: 101766-xx-2005 GW Pharma Lt d !! 0086 LS101604/1.1 i !! Name: Power Supply LabelReference: LS101606/1.1Material: 010 Matt PolycarbonateAdhesive: 3ms 467Finish: MattColour: Back filled Black Print White Medical Device S pecification BS EN 60601-1 21.8 +/-0.2 21.8 +/-0.2 Name: Secure Key LabelReference: LS101604/1.1Material: 010 Matt PolycarbonateAdhesive: 3ms 467Finish: MattColour: Back filled Black Print White Medical Device S pecification BS EN 60601-1 28.5 +/-0.2 13.5 +/-0.2 Name: GSM Controller LabelReference: LS101607/1.1Material: 010 Matt Polycarbonate 3ms 467 Finish: MattColour: Back filled Black Print White Medical Device S pecification BS EN 60601-1Adhesive: 40.5 +/-0.2 Name: SMC LabelReference: LS101603/1.1Material: 010 Matt Polycarbonate 3ms 467 Finish: MattColour: Back filled Black Print White Medical Device S pecification BS EN 60601-1Adhesive: 21 /0 9 /05 2938_UserEvalLabels_1 10405.cdr I:\!PDDWORK\JOBS\GW Pharma\2938_MDS\creative\working\coreldraw\labels GW PharmaceuticalsJ2938 R2.25 R4.4 R1.2 31.7 +/-0.2 R6 GW Pharma Lt d SP4 0JQ UK WARNING: Only to be used with GW drug delivery systems GSM CONTROLLER REF 101763 SN: 101763-xx-2005 Use only with GW power supply REF 101765 provided Input . 6V 800mA Secure Key REF 101766 Port LS101607/1.1 !! 0086 i 44.8 +/-0.2 F WARNING: Only to be used with applicable GW controller LS101603/1.1 SECURE METHADONE CANISTER REF 101764 SN: 101764-xx-2005 GW Pharma Lt d SP4 0JQ UK 0086 !! i 63.5 +/-0.2 49.9 +/-0.2 POWER SUPPL Y SN: 101765-xx-2005GW Pharma Lt d Input: 100-240V ~50Hz/60Hz/0.15A Output: 6V 800mA LS101606/1.1 ii 0086 Name: US GSM Controller LabelReference: LS102553/1Material: 010 Matt Polycarbonate 3ms 467 Finish: MattColour: Back filled Black Print White Medical Device S pecification BS EN 60601-1Adhesive: 40.5 +/-0.2 R4.4 GW Pharma Lt d SP4 0JQ UK WARNING: Only to be used with GW drug delivery systems Use only with GW power supply REF 101765 provided Input . 6V 800mA Secure Key REF 101766 Port LS101607/1.1 !! 0086 i 44.8 +/-0.2 Contains FCC ID CWTUGPZ2

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TEST REPORT FROM RFI GLOBAL SERVICES LTD Test of: GW Pharmaceuticals plc. EP011 Methadone Delivery System. To: FCC Part 22: 2004 (Subpart H) & FCC Part 24 Subpart E: 2002 Test Report Serial No: RFI\MPTE1\RP47081JD05A This Test Report Is Issued Under The Authority Of Andrew Brown, Operations Manager: pp Tested By: Steven Wong pp Checked By: Nigel Davison Report Copy No: PDF01 Issue Date: 20 June 2005 Test Dates: 17 March 2005 to 20 April 2005 This report may be reproduced in full. Partial reproduction may only be made with the written consent of RFI Global Services Ltd. The results in this report apply only to the sample(s) tested. RFI GLOBAL SERVICES LTD TEST REPORT S.No. RFI\MPTE1\RP47081JD05A Page 2 of 68 Issue Date: 20 June 2005 Test of: GW Pharmaceuticals plc. EP011 Methadone Delivery System. To: FCC Part 22: 2004 (Subpart H) & FCC Part 24 Subpart E: 2002 This page has been left intentionally blank. RFI GLOBAL SERVICES LTD TEST REPORT S.No. RFI\MPTE1\RP47081JD05A Page 3 of 68 Issue Date: 20 June 2005 Test of: GW Pharmaceuticals plc. EP011 Methadone Delivery System. To: FCC Part 22: 2004 (Subpart H) & FCC Part 24 Subpart E: 2002 Table of Contents 1. Client Information .........................................................................................................4 2. Equipment Under Test (EUT) .......................................................................................5 3. Test Results...................................................................................................................9 4. Deviations from the Test Specification.....................................................................10 5. Operation of the EUT during Testing ........................................................................11 6. Summary of Test Results FCC Part 22......................................................................12 7. Measurements, Examinations and Derived Results ................................................14 8. Measurement Uncertainty ..........................................................................................52 9. Measurement Methods ...............................................................................................53 Appendix 1. Test Equipment Used ................................................................................63 Appendix 2. Test Configuration Drawings....................................................................65 RFI GLOBAL SERVICES LTD TEST REPORT S.No. RFI\MPTE1\RP47081JD05A Page 4 of 68 Issue Date: 20 June 2005 Test of: GW Pharmaceuticals plc. EP011 Methadone Delivery System. To: FCC Part 22: 2004 (Subpart H) & FCC Part 24 Subpart E: 2002 1. Client Information Company Name: GW Pharmaceuticals Plc. Address: Porton Down Science Park Salisbury Wiltshire SP4 0JQ Contact Name: Mr Rajiv Dave RFI GLOBAL SERVICES LTD TEST REPORT S.No. RFI\MPTE1\RP47081JD05A Page 5 of 68 Issue Date: 20 June 2005 Test of: GW Pharmaceuticals plc. EP011 Methadone Delivery System. To: FCC Part 22: 2004 (Subpart H) & FCC Part 24 Subpart E: 2002 2. Equipment Under Test (EUT) The following information (with the exception of the Date of Receipt) has been supplied by the client: 2.1. Identification of Equipment Under Test (EUT) Brand Name: GW Pharmaceuticals Model Name or Number: EP011 Unique Type Identification: Not Applicable Serial Number: 012345678901231 FCC ID Number: S6C102552 Country of Manufacture: None Stated Date of Receipt: 16 March 2005 RFI GLOBAL SERVICES LTD TEST REPORT S.No. RFI\MPTE1\RP47081JD05A Page 6 of 68 Issue Date: 20 June 2005 Test of: GW Pharmaceuticals plc. EP011 Methadone Delivery System. To: FCC Part 22: 2004 (Subpart H) & FCC Part 24 Subpart E: 2002 2.2. Accessories The following accessories were supplied with the EUT: Description: AC Charger Brand Name: Young’s Model Name or Number: SPA0600800 Serial Number: None Stated Cable Length and Type: 2 Wire, 1.8 m Connected to Port: AC Charger Port Description: Secure Methadone Canister Brand Name: GW Pharmaceuticals Model Name or Number: 101764 Serial Number: 101764-xx-2004 Cable Length and Type: Not Applicable Connected to Port: SMC Connector Port Description: USB Key Brand Name: GW Pharmaceuticals Model Name or Number: Secure Key Serial Number: 101766-xx-2004 Cable Length and Type: Not Applicable Connected to Port: USB Port RFI GLOBAL SERVICES LTD TEST REPORT S.No. RFI\MPTE1\RP47081JD05A Page 7 of 68 Issue Date: 20 June 2005 Test of: GW Pharmaceuticals plc. EP011 Methadone Delivery System. To: FCC Part 22: 2004 (Subpart H) & FCC Part 24 Subpart E: 2002 2.3. Description of EUT The equipment under test is a secure methadone delivery system, operating in the GSM 850 MHz and PCS 1900 MHz bands. 2.4. Modifications Incorporated in EUT During the course of testing the EUT was not modified. RFI GLOBAL SERVICES LTD TEST REPORT S.No. RFI\MPTE1\RP47081JD05A Page 8 of 68 Issue Date: 20 June 2005 Test of: GW Pharmaceuticals plc. EP011 Methadone Delivery System. To: FCC Part 22: 2004 (Subpart H) & FCC Part 24 Subpart E: 2002 2.5. Additional Information Related to Testing Power Supply Requirement: Nominal 115 V, 50 Hz AC Mains supply via an AC Charger & Internal battery supply of 4.2 Intended Operating Environment: Within GSM Coverage Equipment Category: GSM 850/GSM 1900 Type of Unit: Portable (Standalone battery powered via vehicle regulated supply). Transmit Frequency Range: 824.2 MHz to 848.8 MHz and 1850.2 MHz to 1909.8 MHz Channel ID Channel Number Channel Frequency (MHz) Bottom 128/512 824.2/1850.2 Middle 190/660 836.6/1879.8 Transmit Channels Tested: Top 251/810 848.8/1909.8 Receive Frequency Range: 869.2 MHz to 893.8 MHz and 1930.2 MHz to 1989.8 MHz Channel ID Channel Number Channel Frequency (MHz) Bottom 128/512 869.2/1930.2 Middle 190/660 881.6/1960.0 Receive Channels Tested: Top 251/810 893.8/1989.8 Maximum Power Output (ERP) 25.3 dBm 2.6. Support Equipment No support equipment was used to exercise the EUT during testing: RFI GLOBAL SERVICES LTD TEST RE…

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