ZKP-XSCP0001X Series

X Series ™ Operator’s Guide 9650-1355-01 Rev. 1 DRAFT The issue date for the X Series Operator's Guide (REF 9650-1355-01 Rev. 1) is November, 2011. If more than 3 years have elapsed since the issue date, contact ZOLL Medical Corporation to determine if additional product information updates are available. Copyright © 2011 ZOLL Medical Corporation. All rights reserved. CPR-D-padz, pedi-padz, OneStep, Real CPR Help, Rectilinear Biphasic, RescueNet, See-Thru CPR, stat-padz, SurePower, X Series, and ZOLL are trademarks or registered trademarks of ZOLL Medical Corporation in the United States and/or other countries. Masimo Rainbow and Masimo SET are trademarks or registered trademarks of Masimo Corporation in the United States and/or other countries. Propaq, Smartcuf and SureBP are trademarks or registered trademarks of Welch Allyn or its subsidiaries in the United States and other countries. All other trademarks are the property of their respective owners. IC Model: XSCP-1 ZOLL International Holding B.V. Newtonweg 18 6662 PV ELST The Netherlands Tel.: +31 (0) 481 366410 Fax: +31 (0) 481 366411 DRAFT COPY 9650-1355-01 Rev. 1X Series Operator’s Guidei Table of Contents Chapter 1 General Information Product Description ............................................................................................................1-1 X Series Optional Features .........................................................................................1-2 How to Use This Manual.....................................................................................................1-3 Operator’s Guide Updates..................................................................................................1-3 Unpacking...........................................................................................................................1-3 Symbols Used on the Equipment .......................................................................................1-4 Conventions........................................................................................................................1-7 X Series Indications for Use ...............................................................................................1-7 Manual Defibrillation ...................................................................................................1-8 Semiautomatic Operation (AED) ................................................................................1-8 ECG Monitoring ..........................................................................................................1-9 CPR Monitoring ..........................................................................................................1-9 External Transcutaneous Pacing ................................................................................1-9 Non-Invasive Blood Pressure Monitoring .................................................................1-10 Temperature Monitoring ...........................................................................................1-10 SpO2 Monitoring .......................................................................................................1-10 Respiration Monitoring ..............................................................................................1-10 CO2 Monitoring .........................................................................................................1-10 Invasive Pressure Monitoring ...................................................................................1-10 12-Lead Analysis ......................................................................................................1-11 X Series Product Functions .............................................................................................. 1-11 Defibrillator Function .................................................................................................1-11 Defibrillator Output Energy .......................................................................................1-11 External Pacemaker .................................................................................................1-11 ECG Monitoring ........................................................................................................1-12 Electrodes .................................................................................................................1-12 Batteries ....................................................................................................................1-12 Ready For Use (RFU) Indicator ................................................................................1-14 Safety Considerations.......................................................................................................1-15 DRAFT COPY TABLE OF CONTENTS iiwww.zoll.com9650-1355-01 Rev. 1 Warnings...........................................................................................................................1-15 General .....................................................................................................................1-15 ECG Monitoring ........................................................................................................1-16 Defibrillation ..............................................................................................................1-17 Pacing .......................................................................................................................1-18 CPR ......... .................................................................................................................1-19 Pulse Oximeter .........................................................................................................1-19 Noninvasive Blood Pressure .....................................................................................1-20 IBP ..........................................................................................................…

Text truncated - open the document above for the full version.

Northwest EMC TCB Compliance Opinion Rev. 7/1/10 LGPD0044 Information about the Applicant Grantee (Company Name) Zoll Medical Corp FCC Contact Person Carl Mamuszka Address 269 Mill Road City, State, Zip Chelmsford, Massachusetts 01824-4105 Job Number LGPD0044 Model X Series FCC ID ZKP-XSCP0001 Agent Frederick Geheb, Bob Nelson Approval Type Original Equipment Class DTS Digital Transmission System NII National Information Infrastructure Rule Part 15.247, 15.407 Overview The X Series is a medical product manufactured by ZOLL Medical, whose primary function is a a combination monitor/defibrillator. The product contains an embedded communications module with an 802.11 a/b/g/n compliant radio and a Bluetooth radio. In the U.S. the 802.11 radio is restricted to operate in the 2.4, 5.2 and 5.8 GHz bands. Confidentiality requested for allowed files. Request is properly addressed and referenced. Recommendation All items have been resolved and completed to my satisfaction; therefore I recommend this application for approval. Signature Dave Tolman, TCB Committee 1/19/2012

ZOLL X Series – External Views FCC ID: ZKP-XSCP0001 Front View Left Side View Rear View Right Side View Top View from Front Top View from Rear Bottom View Rear View with Battery in Place Battery Bottom View Rear View with Power Pack connected

Made in USA + Use SurePower II Battery ™ Use SurePower II Battery ™ 0197 Monitor/Defibrillator This device is covered by one or more of the following US patents: 6,292,692; 5,507,778; 5,275,158; 5,391,187; 5,249,573; 5,769,872; 5,800,462; 5,733,310; 5,800,463; 5,797,968; 5,904,706; 6,096,063. The capnography component of this product is covered by one or more of the following US patents: 6,428,483; 6,997,880; 5,300,859, 6,437,316; 7,488,229; other patents listed in this product’s Operator’s Guide and their foreign equivalents. Additional patent applications pending. Masimo Patents: This device is covered under one or more of the following U.S.A. patents: 5,758,644, 6,011,986, 6,699,194, 7,215,986, 7,254,433, 7,530,955 and other applicable patents listed at: www.masimo.com/patents.htm. ZOLL Medical Corporation 269 Mill Road Chelmsford, MA 01824-4105 U.S.A. ONLYRx ZOLL International Holding B.V. Newtonweg 18 6662 PV ELST, The Netherlands IP55 EC REP SN PN NSN Bluetooth FCC ID: ZKP-XSCP0001 IC: 9702A-XSCP0001 COMPOSITE TÜVRheinland C U S PMS 427 U Monitor/Defibrillator PMS 3005 C Made in USA + Monitor/Defibrillator This device is covered by one or more of the following US patents: 6,292,692; 5,507,778; 5,275,158; 5,391,187; 5,249,573; 5,769,872; 5,800,462; 5,733,310; 5,800,463; 5,797,968; 5,904,706; 6,096,063. The capnography component of this product is covered by one or more of the following US patents: 6,428,483; 6,997,880; 5,300,859, 6,437,316; 7,488,229; other patents listed in this product’s Operator’s Guide and their foreign equivalents. Additional patent applications pending. Masimo Patents: This device is covered under one or more of the following U.S.A. patents: 5,758,644, 6,011,986, 6,699,194, 7,215,986, 7,254,433, 7,530,955 and other applicable patents listed at: www.masimo.com/patents.htm. ZOLL Medical Corporation 269 Mill Road Chelmsford, MA 01824-4105 U.S.A. ONLYRx ZOLL International Holding B.V. Newtonweg 18 6662 PV ELST, The Netherlands EC REP SN PN NSN Bluetooth PMS 433 U THIS LINE IS EXACTLY 5 INCHES LONG. USE FILM POSITIVE ONLY FOR ARTWORK. PAPER REPRODUCTIONS ARE NOT TO BE USED AS ARTWORK. RELEASED PER ECO 022572 1 CHANGED PER ECO 022796 2 D. LeLACHEUR D. LeLACHEUR 7/08/11 7/08/11 S. BAUCOM F. GEHEB 7/11/11 7/11/11 Artw ork, Label, Nomenclature, X Series REVDESCRIPTION DATE REVISIONS ZOLL MEDICAL CORPORATION 269 MILL ROAD CHELMSFORD, MA 01824-4105 DRW CHK DES APP DATE ARTWORK REV DWG NO. SCALE: SHTOF 1 1 100% 9305-000687-01-AW B B NOTICE: DO NOT SCALE THIS DRAWING PROPRIETARY NOTICE: THIS DOCUMENT IS THE PROPERTY OF ZOLL MEDICAL CORPORATION AND IT CONTAINS CONFIDENTIAL INFORMATION TO BE USED ONLY FOR THE SOLE PURPOSE FOR WHICH IT WAS MADE AVAILABLE. APPR i a . a _ 1 b t r a : E L I F E T A L P M E T 7/11/11 ASB CHANGED PER ECO 023243 3 8/25/11 ASB IC MODEL: XSCP-1 FCC ID: ZKP-XSCP0001 IC: 9702A-XSCP0001 IC MODEL: XSCP-1 10/21/11 GV CHANGED PER ECO 023627 4 0197 IP55 TÜVRheinland C U S 12/15/11 GV ARELEASED PER ECO 023395 B CHANGED PER ECO 12/27/11 GV Rear View

ZOLL X Series – Internal Views FCC ID: ZKP-XSCP0001 CP (ZOLL Part # 3027-000001) Component Side View WLS1273 – Wi-Fi and Bluetooth Radios Hirose U.FL-R-SMT(01) 5 GHz connector Hirose U.FL-R-SMT(01) 2.4 GHz connector CP (ZOLL Part # 3027-000001) Solder Side View CP Antenna (ZOLL Part # 3027-000002) Component Side View 5 GHz PCB Trace Antenna 2.4 GHz PCB Trace Antenna CP Antenna (ZOLL Part # 3027-000002) Solder Side View Hirose U.FL-R-SMT(01) 5 GHz connector Hirose U.FL-R-SMT(01) 2.4 GHz connector CP and Antenna Assembly In position on ZOLL Monitor Board – showing antenna and GPS cable routing (unshielded CP) Antenna - ZOLL PN 3027-000002 CP - ZOLL PN 3027-000001 Unshielded 5 GHz micro-coax cable 2.4 GHz micro-coax cable cable CP and Antenna Assembly In position on ZOLL Monitor Board – showing antenna and shielded CP Antenna - ZOLL PN 3027-000002 CP - ZOLL PN 3027-000001 Shielded

ZOLL Antennas The antennas for the system consist of two printed circuit trace antennas. They are permanently connected within the device using coax cables and U.FL connectors. The user has no access to the antennas, coax cables, or connectors. One is ¼ wavelength monopole at 2.45GHz. Gain is ‐4Dbi 2412 MHz ‐4.6 dBi 2442 MHz ‐4.0 dBi 2472 MHz ‐4.9 dBi The other is ¼ wavelength monopole at 5.4GHz. Gain is 2.7dBi 5180 MHz 1.6 dBi 5320 MHz 2.2 dBi 5500 MHz 2.4 dBi 5700 MHz 2.7 dBi 5825 MHz 1.4 dBi

ZOLL Medical Corp. X Series Report No. LGPD0044.6 Rev 01 Report Prepared By www.nwemc.com 1-888-EMI-CERT © 2011 Northwest EMC, Inc 22975 NW Evergreen Parkway Suite 400 Hillsboro, Oregon 97124 Certificate of Evaluation ZOLL Medical Corp. Model: X Series Emissions Test Description Specification Test Method Pass/Fail Maximum Permissible Exposure FCC 2.1091:2011 OET Bulletin 65, Supplement C Ed 01-01 Pass Modifications made to the product See the Modifications section of this report Approved By: Donald Facteau, IS Manager This report must not be used to claim product certification, approval, or endorsement by NVLAP, NIST, or any agency of the federal government of the United States of America. Product compliance is the responsibility of the client, therefore the tests and equipment modes of operation represented in this report were agreed upon by the client, prior to testing. This Report may only be duplicated in its entirety. The results of this test pertain only to the sample(s) tested. The specific description is noted in each of the individual sections of the test report supporting this certificate of test. Northwest EMC Revision History Revision 05/05/03 Revision Number Description Date Page Number 01 Corrected antenna mfg 1/20/12 9 Accreditations and Authorizations FCC Accredited by NVLAP for performance of FCC radio, digital, and ISM device testing. Our Open Area Test Sites, certification chambers, and conducted measurement facilities have been fully described in reports filed with the FCC and accepted by the FCC in letters maintained in our files. Northwest EMC has been accredited by ANSI to ISO / IEC Guide 65 as a product certifier. We have been designated by the FCC as a Telecommunications Certification Body (TCB). This allows Northwest EMC to certify transmitters to FCC specifications in accordance with 47 CFR 2.960 and 2.962. NVLAP Northwest EMC, Inc. is accredited under the National Voluntary Laboratory Accreditation Program (NVLAP) for satisfactory compliance with the requirements of ISO/IEC 17025 for Testing Laboratories. NVLAP is administered by the National Institute of Standards and Technology (NIST), an agency of the U.S. Commerce Department. The NVLAP accreditation encompasses Electromagnetic Compatibility Testing in accordance with the European Union EMC Directive 2004/108/EC, and ANSI C63.4. Additionally, Northwest EMC is accredited by NVLAP to perform radio testing in accordance with the European Union R&TTE Directive 1999/5/EEC, the requirements of FCC, and the RSS radio standards for Industry Canada. Industry Canada Accredited by NVLAP for performance of Industry Canada RSS and ICES testing. Our Open Area Test Sites and certification chambers comply with RSS-Gen, Issue 2 and have been filed with Industry Canada and accepted. Northwest EMC has been accredited by ANSI to ISO / IEC Guide 65 as a product certifier. We have been designated by NIST and recognized by Industry Canada as a Certification Body (CB) per the APEC Mutual Recognition Arrangement (MRA). This allows Northwest EMC to certify transmitters to Industry Canada technical requirements. (Site Filing Numbers - Hillsboro: 2834D-1, 2834D-2, Sultan: 2834C-1, Irvine: 2834B-1, 2834B-2, Brooklyn Park: 2834E-1) CAB Designated by NIST and validated by the European Commission as a Conformity Assessment Body (CAB) to conduct tests and approve products to the EMC directive and transmitters to the R&TTE directive, as described in the U.S. - EU Mutual Recognition Agreement. Australia/New Zealand The National Association of Testing Authorities (NATA), Australia has been appointed by the ACA as an accreditation body to accredit test laboratories and competent bodies for EMC standards. Accredited test reports or assessments by competent bodies must carry the NATA logo. Test reports made by an overseas laboratory that has been accredited for the relevant standards by an overseas accreditation body that has a Mutual Recognition Agreement (MRA) with NATA are also accepted as technical grounds for product conformity. The report should be endorsed with the respective logo of the accreditation body (NVLAP). Accreditations and Authorizations VCCI Accepted as an Associate Member to the VCCI, Acceptance No. 564. Conducted and radiated measurement facilities have been registered in accordance with Regulations for Voluntary Control Measures, Article 8. (Registration Numbers. - Hillsboro: C-1071, R-1025, G-84, C-2687, T- 1658, and R-2318, Irvine: R-1943, G-85, C-2766, and T-1659, Sultan: R-871, G-83, C-1784, and T-1511, Brooklyn Park: R-3125, G-86, G-141, C-3464, and T-1634). BSMI Northwest EMC has been designated by NIST and validated by C-Taipei (BSMI) as a CAB to conduct tests as described in the APEC Mutual Recognition Agreement (US0017). GOST Northwest EMC, Inc. has been assessed and accredited by the Russian Certification bodies Certinform VNIINMASH, CERTINFO, SAMTES, and Federal CHEC, to perform EMC and Hygienic testing for Information Technology Products. As a result of their laboratory assessment, they will accept test results from Northwest EMC, Inc. for product certification KCC Northwest EMC, Inc is a CAB designated by MRA partners and recognized by Korea. (Assigned Lab Numbers: Hillsboro: US0017, Irvine: US0158, Sultan: US0157, Brooklyn Park: US0175) VIETNAM Vietnam MIC has approved Northwest EMC as an accredited test lab. Per Decision No. 194/QD-QLCL (dated December 15, 2009), Northwest EMC test reports can be used for Vietnam approval submissions. SCOPE For details on the Scopes of our Accreditations, please visit: http://www.nwemc.com/accreditations/ Northwest EMC Locations Oregon Labs EV01-EV12 22975 NW Evergreen Pkwy Suite 400 Hillsboro, OR 97124 (503) 844-4066 California Labs OC01-OC13 41 Tesla Irvine, CA 92618 (949) 861-8918 Minnesota Labs MN01-MN08 9349 W Broadway Ave. Brooklyn Park, MN 55445 (763) 425-2281 Washington Labs SU01-SU07 14128 339 th Ave. SE Sultan, WA 98294 (360) 793-8675 New York Labs WA01-WA04 4939 Jo…

Text truncated - open the document above for the full version.

ZOLL Medical Corp. X Series 802.11 a/b/g/n Report No. LGPD0044 Rev 01 Report Prepared By www.nwemc.com 1-888-EMI-CERT © 2011 Northwest EMC, Inc 22975 NW Evergreen Parkway Suite 400 Hillsboro, Oregon 97124 Certificate of Test Last Date of Test: October 27, 2011 ZOLL Medical Corp. Model: X Series Emissions Test Description Specification Test Method Pass/Fail Occupied Bandwidth FCC 15.247:2011 ANSI C63.10:2009 Pass Output Power FCC 15.247:2011 ANSI C63.10:2009 Pass Band Edge Compliance FCC 15.247:2011 ANSI C63.10:2009 Pass Spurious Conducted Emissions FCC 15.247:2011 ANSI C63.10:2009 Pass Power Spectral Density FCC 15.247:2011 ANSI C63.10:2009 Pass Spurious Radiated Emissions FCC 15.247:2011 ANSI C63.10:2009 Pass AC Powerline Conducted Emissions FCC 15.207:2011 ANSI C63.10:2009 Pass Modifications made to the product See the Modifications section of this report Test Facility The measurement facility used to collect the data is located at: Northwest EMC, Inc. 9349 W Broadway Ave. Brooklyn Park, MN 55445 Phone: (763) 425-2281 Fax: (763) 424-3469 This site has been fully described in a report filed with and accepted by the FCC (Federal Communications Commission) and Industry Canada (Site filing #2834E-1). Approved By: Tim O'Shea, Operations Manager NVLAP Lab Code: 200881-0 This report must not be used to claim product certification, approval, or endorsement by NVLAP, NIST, or any agency of the federal government of the United States of America. Product compliance is the responsibility of the client, therefore the tests and equipment modes of operation represented in this report were agreed upon by the client, prior to testing. This Report may only be duplicated in its entirety. The results of this test pertain only to the sample(s) tested. The specific description is noted in each of the individual sections of the test report supporting this certificate of test. Northwest EMC Revision History Revision 06/29/09 Barometric Pressure The recorded barometric pressure has been normalized to sea level. Revision Number Description Date Page Number 01 Corrected mfg informatjon 1/20/12 8 Accreditations and Authorizations FCC Accredited by NVLAP for performance of FCC radio, digital, and ISM device testing. Our Open Area Test Sites, certification chambers, and conducted measurement facilities have been fully described in reports filed with the FCC and accepted by the FCC in letters maintained in our files. Northwest EMC has been accredited by ANSI to ISO / IEC Guide 65 as a product certifier. We have been designated by the FCC as a Telecommunications Certification Body (TCB). This allows Northwest EMC to certify transmitters to FCC specifications in accordance with 47 CFR 2.960 and 2.962. NVLAP Northwest EMC, Inc. is accredited under the National Voluntary Laboratory Accreditation Program (NVLAP) for satisfactory compliance with the requirements of ISO/IEC 17025 for Testing Laboratories. NVLAP is administered by the National Institute of Standards and Technology (NIST), an agency of the U.S. Commerce Department. The NVLAP accreditation encompasses Electromagnetic Compatibility Testing in accordance with the European Union EMC Directive 2004/108/EC, and ANSI C63.4. Additionally, Northwest EMC is accredited by NVLAP to perform radio testing in accordance with the European Union R&TTE Directive 1999/5/EEC, the requirements of FCC, and the RSS radio standards for Industry Canada. Industry Canada Accredited by NVLAP for performance of Industry Canada RSS and ICES testing. Our Open Area Test Sites and certification chambers comply with RSS-Gen, Issue 2 and have been filed with Industry Canada and accepted. Northwest EMC has been accredited by ANSI to ISO / IEC Guide 65 as a product certifier. We have been designated by NIST and recognized by Industry Canada as a Certification Body (CB) per the APEC Mutual Recognition Arrangement (MRA). This allows Northwest EMC to certify transmitters to Industry Canada technical requirements. (Site Filing Numbers - Hillsboro: 2834D-1, 2834D-2, Sultan: 2834C-1, Irvine: 2834B-1, 2834B-2, Brooklyn Park: 2834E-1) CAB Designated by NIST and validated by the European Commission as a Conformity Assessment Body (CAB) to conduct tests and approve products to the EMC directive and transmitters to the R&TTE directive, as described in the U.S. - EU Mutual Recognition Agreement. Australia/New Zealand The National Association of Testing Authorities (NATA), Australia has been appointed by the ACA as an accreditation body to accredit test laboratories and competent bodies for EMC standards. Accredited test reports or assessments by competent bodies must carry the NATA logo. Test reports made by an overseas laboratory that has been accredited for the relevant standards by an overseas accreditation body that has a Mutual Recognition Agreement (MRA) with NATA are also accepted as technical grounds for product conformity. The report should be endorsed with the respective logo of the accreditation body (NVLAP). Accreditations and Authorizations VCCI Accepted as an Associate Member to the VCCI, Acceptance No. 564. Conducted and radiated measurement facilities have been registered in accordance with Regulations for Voluntary Control Measures, Article 8. (Registration Numbers. - Hillsboro: C-1071, R-1025, G-84, C-2687, T- 1658, and R-2318, Irvine: R-1943, G-85, C-2766, and T-1659, Sultan: R-871, G-83, C-3265, and T-1511, Brooklyn Park: R-3125, G-86, G-141, C-3464, and T-1634). BSMI Northwest EMC has been designated by NIST and validated by C-Taipei (BSMI) as a CAB to conduct tests as described in the APEC Mutual Recognition Agreement (US0017). GOST Northwest EMC, Inc. has been assessed and accredited by the Russian Certification bodies Certinform VNIINMASH, CERTINFO, SAMTES, and Federal CHEC, to perform EMC and Hygienic testing for Information Technology Products. As a result of their laboratory assessment, they will accept test results from Northwest EMC, Inc. for product certification KCC Northwest…

Text truncated - open the document above for the full version.

ZOLL Medical Corp. X Series Bluetooth Report No. LGPD0044.1 Rev 01 Report Prepared By www.nwemc.com 1-888-EMI-CERT © 2011 Northwest EMC, Inc 22975 NW Evergreen Parkway Suite 400 Hillsboro, Oregon 97124 Certificate of Test Last Date of Test: November 16, 2011 Zoll Medical Corp. Model: X Series Emissions Test Description Specification Test Method Pass/Fail Occupied Bandwidth FCC 15.247:2011 ANSI C63.10:2009 Pass Output Power FCC 15.247:2011 ANSI C63.10:2009 Pass Band Edge Compliance FCC 15.247:2011 ANSI C63.10:2009 Pass Spurious Conducted Emissions FCC 15.247:2011 ANSI C63.10:2009 Pass Power Spectral Density FCC 15.247:2011 ANSI C63.10:2009 Pass Channel Spacing FCC 15.247:2011 ANSI C63.10:2009 Pass Number of Hoping Frequencies FCC 15.247:2011 ANSI C63.10:2009 Pass Time of Occupancy (Dwell Time) FCC 15.247:2011 ANSI C63.10:2009 Pass Spurious Radiated Emissions FCC 15.247:2011 ANSI C63.10:2009 Pass AC Powerline Conducted Emissions FCC 15.207:2011 ANSI C63.10:2009 Pass Modifications made to the product See the Modifications section of this report Test Facility The measurement facility used to collect the data is located at: Northwest EMC, Inc. 9349 W Broadway Ave. Brooklyn Park, MN 55445 Phone: (763) 425-2281 Fax: (763) 424-3469 This site has been fully described in a report filed with and accepted by the FCC (Federal Communications Commission) and Industry Canada (Site filing #2834E-1). Approved By: Tim O'Shea, Operations Manager NVLAP Lab Code: 200881-0 This report must not be used to claim product certification, approval, or endorsement by NVLAP, NIST, or any agency of the federal government of the United States of America. Product compliance is the responsibility of the client, therefore the tests and equipment modes of operation represented in this report were agreed upon by the client, prior to testing. This Report may only be duplicated in its entirety. The results of this test pertain only to the sample(s) tested. The specific description is noted in each of the individual sections of the test report supporting this certificate of test. Northwest EMC Revision History Revision 06/29/09 Barometric Pressure The recorded barometric pressure has been normalized to sea level. Revision Number Description Date Page Number 01 Corrected mfg information 1/20/12 8 Accreditations and Authorizations FCC Accredited by NVLAP for performance of FCC radio, digital, and ISM device testing. Our Open Area Test Sites, certification chambers, and conducted measurement facilities have been fully described in reports filed with the FCC and accepted by the FCC in letters maintained in our files. Northwest EMC has been accredited by ANSI to ISO / IEC Guide 65 as a product certifier. We have been designated by the FCC as a Telecommunications Certification Body (TCB). This allows Northwest EMC to certify transmitters to FCC specifications in accordance with 47 CFR 2.960 and 2.962. NVLAP Northwest EMC, Inc. is accredited under the National Voluntary Laboratory Accreditation Program (NVLAP) for satisfactory compliance with the requirements of ISO/IEC 17025 for Testing Laboratories. NVLAP is administered by the National Institute of Standards and Technology (NIST), an agency of the U.S. Commerce Department. The NVLAP accreditation encompasses Electromagnetic Compatibility Testing in accordance with the European Union EMC Directive 2004/108/EC, and ANSI C63.4. Additionally, Northwest EMC is accredited by NVLAP to perform radio testing in accordance with the European Union R&TTE Directive 1999/5/EEC, the requirements of FCC, and the RSS radio standards for Industry Canada. Industry Canada Accredited by NVLAP for performance of Industry Canada RSS and ICES testing. Our Open Area Test Sites and certification chambers comply with RSS-Gen, Issue 2 and have been filed with Industry Canada and accepted. Northwest EMC has been accredited by ANSI to ISO / IEC Guide 65 as a product certifier. We have been designated by NIST and recognized by Industry Canada as a Certification Body (CB) per the APEC Mutual Recognition Arrangement (MRA). This allows Northwest EMC to certify transmitters to Industry Canada technical requirements. (Site Filing Numbers - Hillsboro: 2834D-1, 2834D-2, Sultan: 2834C-1, Irvine: 2834B-1, 2834B-2, Brooklyn Park: 2834E-1) CAB Designated by NIST and validated by the European Commission as a Conformity Assessment Body (CAB) to conduct tests and approve products to the EMC directive and transmitters to the R&TTE directive, as described in the U.S. - EU Mutual Recognition Agreement. Australia/New Zealand The National Association of Testing Authorities (NATA), Australia has been appointed by the ACA as an accreditation body to accredit test laboratories and competent bodies for EMC standards. Accredited test reports or assessments by competent bodies must carry the NATA logo. Test reports made by an overseas laboratory that has been accredited for the relevant standards by an overseas accreditation body that has a Mutual Recognition Agreement (MRA) with NATA are also accepted as technical grounds for product conformity. The report should be endorsed with the respective logo of the accreditation body (NVLAP). Accreditations and Authorizations VCCI Accepted as an Associate Member to the VCCI, Acceptance No. 564. Conducted and radiated measurement facilities have been registered in accordance with Regulations for Voluntary Control Measures, Article 8. (Registration Numbers. - Hillsboro: C-1071, R-1025, G-84, C-2687, T- 1658, and R-2318, Irvine: R-1943, G-85, C-2766, and T-1659, Sultan: R-871, G-83, C-3265, and T-1511, Brooklyn Park: R-3125, G-86, G-141, C-3464, and T-1634). BSMI Northwest EMC has been designated by NIST and validated by C-Taipei (BSMI) as a CAB to conduct tests as described in the APEC Mutual Recognition Agreement (US0017). GOST Northwest EMC, Inc. has been assessed and accredited by the Russian Certification bodies Certinform VNIINMASH, CERTINFO, SAMTES, and Federal CHEC, to perform EMC and Hygi…

Text truncated - open the document above for the full version.

ZOLL Medical Corp. X Series Report No. LGPD0044.2 Rev 01 Report Prepared By www.nwemc.com 1-888-EMI-CERT © 2011 Northwest EMC, Inc 22975 NW Evergreen Parkway Suite 400 Hillsboro, Oregon 97124 Certificate of Test Last Date of Test: October 27, 2011 ZOLL Medical…

Text truncated - open the document above for the full version.