PQC-ST80IAIMAdvanced Interface Module

Instructions for Use ST80i Stress Test System ST80i Stress Test System INSTRUCTIONS FOR USE Edition 1 June 2012 Notices PN 453564XXXXXX June 2012 Edition 1 Printed in the USA Edition History Edition 1, June 2012 Applicable to ST80i, version A01.00 and later. Philips Medical Systems shall not be liable for errors contained herein or for incidental or consequential damages in connection with the furnishing, performance, or use of this material. Copyright Copyright © 2012 Koninklijke Philips Electronics N.V. All rights are reserved. Andover, MA 01810-1099 USA (978) 687-1501 Warranty Philips Medical Systems reserves the right to make changes to both this Instructions for Use and to the product that it describes. Product specifications are subject to change without notice. Nothing contained within this Instructions for Use is intended as any offer, warranty, promise, or contractual condition, and must not be taken as such. Responsibility of Manufacturer Philips Medical Systems only considers itself responsible for any effects on safety, reliability, and performance of the StressVue system if: – assembly operations, exten- sions, re-adjustments, modifica- tions or repairs are done by persons authorized by Philips Medical Systems, and – the electrical installation of the relevant room or vehicle complies with the IEC or national requirements, and – the instrument is used according to the instructions for use presented in this manual. Authorized EU-representative Philips Medizin Systeme Böblingen GmbH Hewlett Packard Str. 2 71034 Böblingen Germany European Directives This product consists of hardware and software. The hardware carries the CE mark based on the declarations provided in the User’s Guide for the IT hardware. The ST80i software, the wireless patient module, and the Philips thermal printer are class IIa medical devices under the Medical Device Directive 93/42/EEC and carry the 0123 mark accordingly. CAUTION THIS PRODUCT IS NOT INTENDED FOR HOME USE. IN THE U.S., FEDERAL LAW RESTRICTS THIS DEVICE TO SALE ON OR BY THE ORDER OF A PHYSICIAN. Responsibility of Customer The user of this product is responsible for ensuring the implementation of a satisfactory maintenance schedule. Failure to do so may cause undue failure and possible health hazards. Global Medical Device Nomenclature (GMDN) The 5-digit GMDN code adjacent to the symbol is defined in the EN ISO 15225. WARNINGS As with all electronic equipment, Radio Frequency (RF) interference between the ST80i system and any existing RF transmitting or receiving equipment at the installation site, including electrosurgical equipment, should be evaluated carefully and any limitations noted before the equipment is placed in service. Radio frequency generation from electrosurgical equipment and close proximity transmitters may seriously degrade performance. Philips Medical Systems assumes no liability for failure resulting from RF interference between Philips Medical Systems medical electronics and any radio frequency generating equipment at levels exceeding those established by applicable standards. Use of accessories other than those recommended by Philips Medical Systems may compromise product performance. Trademarks Windows is a registered trademark of Microsoft Corporation. All other brand and product names are trademarks or registered trademarks of their respective companies. GMDN36145 Chapter 1Contents i Safety Summary Conventions Used in the Instructions for Use. . . . . . . . . . . . . . . . . . . i Symbols Marked on the ST80i System . . . . . . . . . . . . . . . . . . . . . . . i Symbols Marked on the ST80i System Packaging . . . . . . . . . . . . . . iii Disposal Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iii Important Patient and Safety Information . . . . . . . . . . . . . . . . . . . . iv Safety Information for the ST80i Stress Test System . . . . . . . . iv Warning Statements for the ST80i System . . . . . . . . . . . . . . . iv Caution Statements for the ST80i System . . . . . . . . . . . . . . . vii Important Notes about the ST80i System . . . . . . . . . . . . . . . viii Safety Information for the Medical Isolation Transformer. . . . . ix Warning Statements about the Medical Isolation Transformer ix Caution Statements about the Medical Isolation Transformer ix Important Notes about the Medical Isolation Transformer . . . ix Safety Information for the Advanced Interface Module . . . . . . .x Caution Statements for the Advanced Interface Module . . . . .x Important Notes about the Advanced Interface Module . . . . . .x Safety Information for the Wireless Patient Interface Module . xi Warnings about the Wireless Patient Interface Module . . . . . xi Caution Statements for the Wireless Patient Interface Module xii Important Notes about the Wireless Patient Interface Module xiii Security Recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xv The Philips ST80i Stress Test System . . . . . . . . . . . . . . . . . . . . . . xvii Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xvii Indications for Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xvii Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xvii The CAlg-STR Exercise ECG Analysis Algorithm . . . . . . . . . . . xviii Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xviii Indications for Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xviii Chapter 1. About the Philips ST80i Stress Test System Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2 About ST80i Documentation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3 Available Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3 Conventions Used in this Guide . . . . . . . . . . . . . . . . . . . . . . . . 1-4 How to U…

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Philips Medical Systems North America Co. 3000 Minuteman Road, Andover, Massachusetts, United States, 01810-1099 Tel: 978-659-3382 Fax: 978-659-7561 Power of Attorney Federal Communication Commission Office of Engineering and Technology Equipment Authorization Division 7345 Oakland Mills Road Columbia, Maryland 21046 We, Company: Philips Medical Systems North America Co. Address: 3000 Minuteman Road, Andover, Massachusetts, United States, 01810-1099 Would like to inform you that we nominated Audix Technology (Shanghai) Co., Ltd, Mr. Byron Kwo to act on behalf of our Philips Medical Systems North America Co. to apply FCC ID: PQC-ST80IAIM for the product with our brand. Kind Regards, Place, date Signature ________________ ________________ 2012-04-20 Delroy Smith

Request for Confidentiality Date: Apr 20, 2012 Subject: Confidentiality Request for FCC ID: PQC-ST80IAIM Pursuant to FCC 47 CRF 0.457(d) and 0.459 and IC RSP-100, Section 10, the applicant requests that a part of the subject FCC application be held confidential. Type of Confidentiality Requested Exhibit Short Term Permanent Block Diagrams Short Term External Photos Short Term Permanent* 1 Internal Photos Short Term Permanent Operation Description/Theory of Operation Short Term Permanent Schematics Short Term Permanent Hopping list Short Term Test Setup Photos Short Term Permanent* User’s Manual *Note: ______ ______ Philips Medical Systems North America Co. has spent substantial effort in developing this product and it is one of the first of its kind in industry. Having the subject information easily available to "competition" would negate the advantage they have achieved by developing this product. Not protecting the details of the design will result in financial hardship. Permanent Confidentiality: The applicant requests the exhibits listed above as permanently confidential be permanently withheld from public review due to materials that contain trade secrets and proprietary information not customarily released to the public. Short-Term Confidentiality: The applicant requests the exhibits selected above as short term confidential be withheld from public view for a period of ___(specify number of days not to exceed 180 ) 2 ___ days from the date of the Grant of Equipment Authorization and prior to marketing. This is to avoid premature release of sensitive information prior to marketing or release of the product to the public. Applicant is also aware that they are responsible to notify ATCB in the event information regarding the product or the product is made available to the public. ATCB will then release the documents listed above for public disclosure pursuant to FCC Public Notice DA 04-1705. Sincerely, By: __________________________ Delroy Smith Title: Principal Scientist / Project Leader On behalf: Philips Medical Systems North America Co. Telephone: 978-659-3382 1 - The asterisked items (*) require further justification before permanent confidentiality will be allowed. These also currently require review by the FCC under their Permit-But-Ask policy before the grant is issued and can delay completion of an application. Further justification should be added to the note above. One such example for a potted device would be: “The EUT is FULLY potted using a non-removable epoxy based material. Removal of potting material causes irreparable damage to internal circuitry. See photographs exhibits that outline the device before and after potting.” 2 - Please refer to http://atcb.com/publicdocs/Memo-Short-Term-Vs-Standard-Confidentiality.pdf for complete details.

FIGURE 1 ADVANCED INTERFACE MODULE (M/N: ST80I AIM) GENERAL APPEARANCE (FRONT VIEW) F IGURE 2 ADVANCED INTERFACE MODULE (M/N: ST80I AIM) GENERAL APPEARANCE (BACK VIEW) FIGURE 3 ADVANCED INTERFACE MODULE (M/N: ST80I AIM) GENERAL APPEARANCE (PORTS #1 VIEW) F IGURE 4 ADVANCED INTERFACE MODULE (M/N: ST80I AIM) GENERAL APPEARANCE (PORTS #2 VIEW) FIGURE 5 ADVANCED INTERFACE MODULE (M/N: ST80I AIM) ANTENNA F IGURE 6 ADVANCED INTERFACE MODULE (M/N: ST80I AIM) USB CABLE

Philips Healthcare–DECG, Specialty and Emerging Markets, PCCI Rev. A Page 1 of 1 Title: Philips ST80i AIM Regulatory Label placement

FIGURE 1 A DVANCED INTERFACE MODULE (M/N: ST80I AIM) COVER REMOVED FIGURE 2 ADVANCED INTERFACE MODULE (M/N: ST80I AIM) MAIN BOARD (FRONT VIEW) F IGURE 3 ADVANCED INTERFACE MODULE (M/N: ST80I AIM) MAIN BOARD (BACK VIEW) FIGURE 4 ADVANCED INTERFACE MODULE (M/N: ST80I AIM) CHIP & CRYSTAL #1 ON MAIN BOARD F IGURE 5 ADVANCED INTERFACE MODULE (M/N: ST80I AIM) CHIP & CRYSTAL #2 ON MAIN BOARD FIGURE 6 ADVANCED INTERFACE MODULE (M/N: ST80I AIM) RF MODULE ON MAIN BOARD

Philips Medical Systems North America Co. FCC ID: PQC-ST80IAIM Page 1 of 16 Audix Technology (Shanghai) Co., Ltd. Report No.: ACI-F12022 Prepared For : Philips Medical Systems North America Co. 3000 Minuteman Road, Andover, Massachusetts, United States, 01810 Prepared By : Audix Technology (Shanghai) Co., Ltd. 3F and 4F 34Bldg 680 Guiping Rd, Caohejing Hi-Tech Park, Shanghai 200233, China Tel: +86-21-64955500 Fax: +86-21-64955491 Report No. : ACI-F12022 Date of Test : Jan 20 – 21, 2012 Date of Report : Feb 22, 2012 Application for FCC Certificate On Behalf of Philips Medical Systems North America Co. Advanced Interface Module Model No.: ST80i AIM Serial No.: AWD1100021 FCC ID : PQC-ST80IAIM Philips Medical Systems North America Co. FCC ID: PQC-ST80IAIM Page 2 of 16 Audix Technology (Shanghai) Co., Ltd. Report No.: ACI-F12022 TABLE OF CONTENTS Page 1 SUMMARY OF STANDARDS AND RESULTS .......................................................................... 4 1.1 Description of Standards and Results ......................................................................................... 4 2 GENERAL INFORMATION .......................................................................................................... 5 2.1 Description of Equipment Under Test ........................................................................................ 5 2.2 Peripherals .................................................................................................................................. 5 2.3 Description of Test Facility ........................................................................................................ 6 2.4 Measurement Uncertainty .......................................................................................................... 6 3 CONDUCTED EMISSION TEST .................................................................................................. 7 3.1 Test Equipment ........................................................................................................................... 7 3.2 Block Diagram of Test Setup ..................................................................................................... 7 3.3 Conducted Emission Limit [FCC Part 15 Subpart B 15.107(a)] ................................................ 8 3.4 Test Configuration ...................................................................................................................... 8 3.5 Operating Condition of EUT ...................................................................................................... 8 3.6 Test Procedures .......................................................................................................................... 8 3.7 Test Results ................................................................................................................................ 9 4 RADIATED EMISSION TEST ..................................................................................................... 11 4.1 Test Equipment ......................................................................................................................... 11 4.2 Block Diagram of Test Setup ................................................................................................... 11 4.3 Radiated Emission Limit [FCC Part 15 Subpart B 15.109(a)] ................................................. 13 4.4 Test Configuration .................................................................................................................... 13 4.5 Operating Condition of EUT .................................................................................................... 13 4.6 Test Procedures ........................................................................................................................ 13 4.7 Test Results .............................................................................................................................. 14 5 DEVIATION TO TEST SPECIFICATIONS .............................................................................. 16 Philips Medical Systems North America Co. FCC ID: PQC-ST80IAIM Page 3 of 16 Audix Technology (Shanghai) Co., Ltd. Report No.: ACI-F12022 TEST REPORT FOR FCC CERTIFICATE Applicant : Philips Medical Systems North America Co. Manufacturer : Philips Medical Systems North America Co. EUT Description : Advanced Interface Module (A) Model No. : ST80i AIM (B) Serial No. : AWD1100021 (C) Test Voltage : DC 5V (USB Power) for Host unit, DC 1.5V (AA Battery) for Patient unit Test Procedure Used: FCC RULES AND REGULATIONS PART 15 SUBPART B CLASS B OCTOBER 2010 AND ANSI C63.4-2003 The device described above is tested by Audix Technology (Shanghai) Co., Ltd. to determine the maximum emission levels emanating from the device. The maximum emission levels are compared to the FCC Part 15 Subpart B (Class B) limits both radiated and conducted emissions. The test results are contained in this test report and Audix Technology (Shanghai) Co., Ltd. is assumed full responsibility for the accuracy and completeness of these measurements. This report shows that the EUT (M/N: ST80i AIM; S/N: AWD1100021) which was tested in 3m anechoic chamber Jan 20 – 21, 2012 is technically compliance with the FCC official limits also. This report applies to above tested sample only. This report shall not be reproduced in part without written approval of Audix Technology (Shanghai) Co., Ltd. This report contains data that are not covered by the NVLAP accreditation. This report must not be used by the client to claim product certification, approval, or endorsement by NVLAP, NIST, or any agency of the federal government. The test result for RF function of the EUT is contained in No.F12023, Certificate reports. Date of Test : Jan 20 – 21, 2012 Date of Report : Feb 22, 2012 Producer : ALAN HE / Assistant Review : SAMMY CHEN / Deputy Manager Signatory : BYRON KWO/ Senior Manager Philips Medical Systems North America Co…

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Philips Medical Systems North America Co. FCC ID: PQC-ST80iAIM Page 1 of 16 Audix Technology (Shanghai) Co., Ltd. Report No.: ACI-F12022 Prepared For : Philips Medical Systems North America Co. 3000 Minuteman Road, Andover, Massachusetts, United States, 01810 Prepared By : Audix Technology (Shanghai) Co., Ltd. 3F and 4F 34Bldg 680 Guiping Rd, Caohejing Hi-Tech Park, Shanghai 200233, China Tel: +86-21-64955500 Fax: +86-21-64955491 Report No. : ACI-F12022 Date of Test : Jan 20 – 21, 2012 Date of Report : Feb 22, 2012 Application for FCC Certificate On Behalf of Philips Medical Systems North America Co. Advanced Interface Module Model No.: ST80i AIM Serial No.: AWD1100021 FCC ID : PQC-ST80iAIM Philips Medical Systems North America Co. FCC ID: PQC-ST80iAIM Page 2 of 16 Audix Technology (Shanghai) Co., Ltd. Report No.: ACI-F12022 TABLE OF CONTENTS Page 1 SUMMARY OF STANDARDS AND RESULTS .......................................................................... 4 1.1 Description of Standards and Results ......................................................................................... 4 2 GENERAL INFORMATION .......................................................................................................... 5 2.1 Description of Equipment Under Test ........................................................................................ 5 2.2 Peripherals .................................................................................................................................. 5 2.3 Description of Test Facility ........................................................................................................ 6 2.4 Measurement Uncertainty .......................................................................................................... 6 3 CONDUCTED EMISSION TEST .................................................................................................. 7 3.1 Test Equipment ........................................................................................................................... 7 3.2 Block Diagram of Test Setup ..................................................................................................... 7 3.3 Conducted Emission Limit [FCC Part 15 Subpart B 15.107(a)] ................................................ 8 3.4 Test Configuration ...................................................................................................................... 8 3.5 Operating Condition of EUT ...................................................................................................... 8 3.6 Test Procedures .......................................................................................................................... 8 3.7 Test Results ................................................................................................................................ 9 4 RADIATED EMISSION TEST ..................................................................................................... 11 4.1 Test Equipment ......................................................................................................................... 11 4.2 Block Diagram of Test Setup ................................................................................................... 11 4.3 Radiated Emission Limit [FCC Part 15 Subpart B 15.109(a)] ................................................. 13 4.4 Test Configuration .................................................................................................................... 13 4.5 Operating Condition of EUT .................................................................................................... 13 4.6 Test Procedures ........................................................................................................................ 13 4.7 Test Results .............................................................................................................................. 14 5 DEVIATION TO TEST SPECIFICATIONS .............................................................................. 16 Philips Medical Systems North America Co. FCC ID: PQC-ST80iAIM Page 3 of 16 Audix Technology (Shanghai) Co., Ltd. Report No.: ACI-F12022 TEST REPORT FOR FCC CERTIFICATE Applicant : Philips Medical Systems North America Co. Manufacturer : Philips Medical Systems North America Co. EUT Description : Advanced Interface Module (A) Model No. : ST80i AIM (B) Serial No. : AWD1100021 (C) Test Voltage : DC 5V (USB Power) for Host unit, DC 1.5V (AA Battery) for Patient unit Test Procedure Used: FCC RULES AND REGULATIONS PART 15 SUBPART B CLASS B OCTOBER 2010 AND ANSI C63.4-2003 The device described above is tested by Audix Technology (Shanghai) Co., Ltd. to determine the maximum emission levels emanating from the device. The maximum emission levels are compared to the FCC Part 15 Subpart B (Class B) limits both radiated and conducted emissions. The test results are contained in this test report and Audix Technology (Shanghai) Co., Ltd. is assumed full responsibility for the accuracy and completeness of these measurements. This report shows that the EUT (M/N: ST80i AIM; S/N: AWD1100021) which was tested in 3m anechoic chamber Jan 20 – 21, 2012 is technically compliance with the FCC official limits also. This report applies to above tested sample only. This report shall not be reproduced in part without written approval of Audix Technology (Shanghai) Co., Ltd. This report contains data that are not covered by the NVLAP accreditation. This report must not be used by the client to claim product certification, approval, or endorsement by NVLAP, NIST, or any agency of the federal government. The test result for RF function of the EUT is contained in No.F12023, Certificate reports. Date of Test : Jan 20 – 21, 2012 Date of Report : Feb 22, 2012 Producer : ALAN HE / Assistant Review : SAMMY CHEN / Deputy Manager Signatory : BYRON KWO/ Senior Manager Philips Medical Systems North America Co…

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