T9I-914205MedStream Control Unit

DRAFT 204268 DRAFT Rev A MedStream Control Unit IFU 1 of 18 6/15/2006 Codman Neuro Sciences (logo) MedStream™ Control Unit Codman Neuro Sciences Sàrl Rue Girardet 29 CH 2400 Le Locle, Switzerland +41 32 933 83 00 Codman & Shurtleff, Inc. 325 Paramount Drive Raynham, MA 02767-0350 USA 800 225 0460 +1 508 828 3000 Codman (logo) A division of Johnson & Johnson Medical Ltd. Coronation Road, Ascot Berkshire SL5 9EY United Kingdom 0086 0889 Authorized 20XX LCN 204268-001/A  2006 Codman & Shurtleff, Inc. (recycle symbol) Printed mm/yy DRAFT 204268-5 DRAFT: MedStream Control Unit IFU 2 of 18 6/15/2006 Table of Contents Brief Product Description Indications Contraindications WARNINGS PRECAUTIONS Adverse Events PRODUCT DESCRIPTION Control Unit Control Unit Audible Signals and Alarms Function and Intended Application Universal Battery Charger USB Printer Cable INSTRUCTIONS FOR USE Setting Up the Control Unit Communicating with a MedStream Pump Positioning the Control Unit for Transmission to a Pump Turning Off the Control Unit Safety Information Preventive Maintenance Cleaning Disinfection Sterilization Service and Repair End of Useful Life Control Unit Technical Specifications Control Unit Environmental Conditions Warranty Appendix A – Tables Table 1 Guidance and Manufacturer’s Declaration – Electromagnetic Emissions Table 2 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity Table 3 Guidance and Manufacturer’s Declaration – Electromagnetic Emissions, Equipment and Systems That Are NOT Life-supporting Table 4 Recommended Separation Distances DRAFT 204268-5 DRAFT: MedStream Control Unit IFU 3 of 18 6/15/2006 IMPORTANT INFORMATION Please Read Before Use MedStream™ Control Unit FCC ID: T9I-914205 IC: 6518A-914205 IMPORTANT: This equipment has been tested and found to comply with the limits for a Class B digital device, 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 instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his own expense. IMPORTANT: This device complies with the Class B limits for radio noise emissions as set out in the interference-causing equipment standard entitled “Digital Apparatus“ ICES-003 of Industry Canada. Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device. Brief Product Description The MedStream Control Unit is part of a system for the intrathecal delivery of selected drugs for pain management or relief of spasticity. It is designed for communicating with and programming the MedStream™ Implantable Programmable Infusion Pump. CAUTION: Do not use the MedStream Control Unit without ensuring a thorough familiarity with the information contained in this manual, the pump instructions and the MedStream Control Unit Programming Guide. Failure to adhere to these instructions can result in patient complications ranging from failure of the intended therapy to drug underdose or overdose. Indications The MedStream Control Unit is used to program the MedStream Implantable Programmable Infusion Pump for the medication therapy indicated in the pump Instructions for Use. Contraindications There are no known contraindications for the use of the control unit. Observe all contraindications relating to the use of the prescribed drug. DRAFT 204268-5 DRAFT: MedStream Control Unit IFU 4 of 18 6/15/2006 WARNINGS Do not modify or change the control unit. Unauthorized changes or modifications to the control unit might cause a malfunction that could result in serious patient injury or death and could void the user’s authority to operate the equipment. Immediately investigate with the control unit if the pump alarm sounds. Immediately empty the pump reservoir if the error message is “Pump Hardware Failure.” These conditions can cause a drug overdose. See the MedStream Control Unit Programming Guide for further information. Do not open the control unit case. There are no user serviceable parts. See Service and Repair. Do not immerse the control unit in liquid. Damage to the unit may result. Do not use the control unit in the presence of flammable gases or near flammable materials. PRECAUTIONS Do not use the MedStream Control Unit with any other programmable infusion pump. Do not rely only on the “fuel gauge” indicator on the control unit screen to determine precisely the life of the pump battery. This indicator provides an estimate of the remaining useful life of the pump battery. Do not place the pump on a metal surface when using the control unit for preoperative preparation. Do not expose the control unit or the hardware key to electromagnetic fields or ionizing radiation, such as MRI or X- rays. Be aware that medical electrical equipment needs special precautions regarding electromagnetic compatibility. This equipment must be installed and put into service according to the electromagnetic compatibility information provided in this manual. Be aware that portable and mobile RF communications equipment can affect medical electrical equipment. Be aware that the use of cables other than those included with the control unit can result in increased emissions or decreased immunity of the equipment. Avoid using the control unit adjacent to or stacked with other electronic equipment. If adjacent or stacked use is necessary, observe the system to verify normal operation in the configuration in which it will be used. Use only the battery charger provided to recharge the control unit battery. Av…

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Date: May 18, 2006 Attention: Application Examiner Reviewing Engineer Re: Request for confidentiality per Section 0.459 of FCC Rules Applicant: Codman Neuroscience SARL rue Girardet 29 CH-2400 Le Locle Switzerland FCC ID: T9I-914205 _______________________________________________________________________ To whom it may concern, Request is hereby submitted by Codman Neuroscience SARL, to withhold from public review certain portions of the application for equipment certification for the referenced FCC identifier. In particular, the following sections of the application and report are requested to be kept confidential: • Schematics and part lists • Detailed Block diagrams • Detailed Operational/Functional Description Rationale for request for confidentiality: Codman Neuroscience SARL wishes to keep these items confidential to maintain a competitive advantage in the marketplace. The $145 fee for confidentiality has been submitted along with the fee for certification. If you need further information, please contact: Luc Bossoney R&D Senior Engineer Medos SA, Codman S.itr.1 Johnson & Johnson 29, rue Girardet CH-2400 Le Locle Tel.: +41 (0)32 1933 02 65 Fax: +41 (0)32 / 933 83 10 Sincerely, Sincerely, CODMAN NEUROSCIENCES SAIU CODMAN NEUROSCIENCES SARL

TEST REPORT FROM RFI GLOBAL SERVICES LTD Test of: Codman NeuroSciences Sarl. MedStream TM Infusion Control Unit (Transceiver) To: FCC Part 15.225 Test Report Serial No: RFI/MPTE2/RP48039JD05A Supersedes Test Report Serial No: RFI/MPTE1/RP48039JD05A This Test Report Is Issued Under The Authority Of Andrew Brown, Operations Manager: Tested By: Raul Recio pp Checked By: Steven Wong Report Copy No: PDF01 Issue Date: 22 June 2006 Test Dates: 21 February 2006 to 23 February 2006 This report is issued in Adobe Acrobat portable document format (PDF). It is only a valid copy of the report if it is being viewed in PDF format with the following security options not allowed: Changing the document, Selecting text and graphics, Adding or changing notes and form fields. This report may be copied in full. The results in this report apply only to the sample(s) tested. RFI GLOBAL SERVICES LTD TEST REPORT S.No. RFI/MPTE2/RP48039JD05A Page: 2 of 2 Issue Date: 22 June 2006 Test of: Codman NeuroSciences Sarl. MedStream TM Infusion Control Unit (Transceiver) To: FCC Part 15.225 This page has been left intentionally blank. RFI GLOBAL SERVICES LTD TEST REPORT S.No. RFI/MPTE2/RP48039JD05A Page: 3 of 3 Issue Date: 22 June 2006 Test of: Codman NeuroSciences Sarl. MedStream TM Infusion Control Unit (Transceiver) To: FCC Part 15.225 Table of Contents 1. Client Information ............................................................................................................................4 2. Equipment Under Test (EUT) ..........................................................................................................5 3. Test Specification, Methods and Procedures ...............................................................................9 4. Deviations from the Test Specification........................................................................................10 5. Operation of the EUT During Testing...........................................................................................11 6. Summary of Test Results ..............................................................................................................12 7. Measurements, Examinations and Derived Results ...................................................................13 8. Measurement Uncertainty .............................................................................................................26 9. Measurement Methods ..................................................................................................................27 Appendix 1. Test Equipment Used ...................................................................................................32 Appendix 2. Test Configuration Drawings.......................................................................................33 Appendix 3. Photographs of EUT .....................................................................................................36 Appendix 4. Document ‘Appendix to Configuration Item Listing Record and Certificate of Conformity – Product Code 91-4205, dated 9 th February 2006’ .....................................41 Appendix 5. Document ‘Appendix to Configuration Item Listing Record and Certificate of Conformity – Product Code 91-4205, dated 13 th February 2006’ ...................................42 Appendix 6. MedStream Bugs List SSTP2.......................................................................................43 Test Report Serial No: RFI/MPTE2/RP48039JD05A Supersedes Test Report Serial No: RFI/MPTE1/RP48039JD05A RFI GLOBAL SERVICES LTD TEST REPORT S.No. RFI/MPTE2/RP48039JD05A Page: 4 of 4 Issue Date: 22 June 2006 Test of: Codman NeuroSciences Sarl. MedStream TM Infusion Control Unit (Transceiver) To: FCC Part 15.225 1. Client Information Company Name: Codman NeuroSciences Sarl. Address: Rue Girardet 29 Case Postale 128 Le Locle Switzerland CH-2400 Contact Name: Mr A. Ginggen RFI GLOBAL SERVICES LTD TEST REPORT S.No. RFI/MPTE2/RP48039JD05A Page: 5 of 5 Issue Date: 22 June 2006 Test of: Codman NeuroSciences Sarl. MedStream TM Infusion Control Unit (Transceiver) To: FCC Part 15.225 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: Codman NeuroSciences Sarl (MedStream Control Unit (CU)) Model Name or Number: 91-4205 Serial Number: 05M01043 (used for all idle mode testing) Hardware Revision: PDL (MR-1000093, Rev 15 see Appendices 4 & 5 for full information) Software Revision: PS-100014 Software Version Number: Rev. 1 FCC ID: T9I-914205 Country of Manufacture: Switzerland Date of Receipt: 21 February 2006 Brand Name: Codman NeuroSciences Sarl (MedStream Control Unit (CU)) Model Name or Number: 91-4205 Serial Number: 05M01027 (used for all transmitter tests except AC conduced emissions) Hardware Revision: PDL (MR-1000093, Rev 15 see Appendices 4 & 5 for full information) Software Revision: PS-100467 Software Version Number: Rev. 15 FCC ID: T9I-914205 Country of Manufacture: Switzerland Date of Receipt: 21 February 2006 RFI GLOBAL SERVICES LTD TEST REPORT S.No. RFI/MPTE2/RP48039JD05A Page: 6 of 6 Issue Date: 22 June 2006 Test of: Codman NeuroSciences Sarl. MedStream TM Infusion Control Unit (Transceiver) To: FCC Part 15.225 Identification of Equipment Under Test (EUT) (Continued) Brand Name: Codman NeuroSciences Sarl (MedStream Control Unit (CU)) Model Name or Number: 91-4205 Serial Number: *05M01035 (used for transmitter AC mains conducted emissions only) Hardware Revision: PDL (MR-1000093, Rev 15 see Appendices 4 & 5 for full information) Software Revision: PS-100467 Software Version Number: Rev. 15 FCC ID: T9I-914205 Country of Manufacture: Switzerland Date of Receipt: 21 February 2006 *EUT was fitted with a 50 ohm termination instead of an antenna to facilitate testing of AC mains conducted emissions. Brand Name: Mascott (MedStream CU Charger) Model Name or Number:…

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Radiated Spurious Emissions Receiver AC Line-conducted emissions Receiver AC Line-conducted emissions Transmitter AC Line-conducted emissions