2AB7ET620ISEsweat II sweat chloride analyzer

ISEsweat II ® Sweat Chloride Analyzer User’s manual V00EVP012014 INDEX 1. INTRODUCTION ........................................................................................................................ 5 1.1 ISEsweat intended use............................................................................................ 6 1.2 Operating principles ............................................................................................... 6 1.3 How to use this manual .......................................................................................... 7 2. DEVICE DESCRIPTION ............................................................................................................. 8 2.1 ISEsweat ................................................................................................................ 9 2.2 Terminal or receiver base ..................................................................................... 10 2.3 Remote module ................................................................................................... 11 2.4 SENSOR CARDS ..................................................................................................... 12 3. ISESWEAT INSTALLATION ................................................................................................. 13 3.1 Components ......................................................................................................... 14 3.2 Power source connection ..................................................................................... 14 3.3 Battery ................................................................................................................. 16 4. SWEAT ANALYSIS .................................................................................................................. 19 4.1 Settings ................................................................................................................ 20 4.2 Sweat induction and analysis ................................................................................ 22 4.3 Interpreting of sweat test results .......................................................................... 27 4.4 Calibration and control ......................................................................................... 27 4.5 Quality Control Mode (QC)-ISEtrol N and ISEtrol A ................................................ 28 5. DATA PORT USE..................................................................................................................... 30 5.1 General summary ................................................................................................. 31 5.2 Data port connection............................................................................................ 31 5.3 Print Data ............................................................................................................. 31 5.4 Memory ............................................................................................................... 33 6. MAINTENANCE ....................................................................................................................... 35 6.1 Technical service .................................................................................................. 36 6.2 Periodic security check ......................................................................................... 36 6.3 Cleaning ............................................................................................................... 36 6.4 Waste management ............................................................................................. 37 ANNEX A: TROUBLESHOOTING TABLE ................................................................................... 38 ANNEX B PRODUCT SPECIFICATIONS ..................................................................................... 40 ANNEX C POSSIBLE INTERFERENCE ........................................................................................ 43 ANNEX D RECOMMENDATIONS FOR THE RESULTS INTERPRETATION ...................... 45 ANNEX E SYMBOL DEFINITIONS ............................................................................................... 47 ANNEX F REGULATIONS ............................................................................................................... 50 ANNEX G MANUFACTURER DECLARATION ........................................................................... 53 ANNEX H WARRANTY ................................................................................................................... 56 ANNEX I HISTORY SWEAT TEST ................................................................................................ 58 ANNEX J REFERENCE ..................................................................................................................... 60 1. INTRODUCTION ISEsweat  - User’s Manual 6 1.1 ISEsweat intended use ISEsweat is intended for quantitative pilocarpine iontophoresis sweat chloride testing for the diagnosis of cystic fibrosis. ISEsweat should only be used by Doctors, nurses and trained laboratory personnel. It is highly recommended that users gain prior experience before diagnosing Cystic Fibrosis. The place for testing may be in laboratories, hospitals or clinics In order to increase the possibility of collecting an adequate sweat sample, it is advisable to conduct the first chloride sweat determination tests on individuals older than 2 weeks and weighing above 2kg. Sweat volumes are dependant on age, sex, corporal weight, race, skin condition and sampling system. ISEsweat ® is a Sweat Chloride Analyzer intended for Cystic Fibrosis Diagnosis. CAUTION: ISEsweat ® is intended only as a supplement in a patients’ evaluation. It must be used in conjunction with other signs and symptoms. Don’t take any clinical decision based only on the sweat test evaluations. 1.2 Operating principles Cystic fibrosis is a multisystem diso…

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Report No.: ER/2014/10004 FCC ID: 2AB7ET620 Issue Date: Apr. 11, 2014 Unless otherwise stated the results shown in this test report refer only to the sample(s) tested and such sample(s) are retained for 90 days only. 說留不 This document is issued by the Company subject to its General Conditions of Service printed overleaf, available on request or accessible at www.sgs.com/terms_and_conditions.htm and, for electronic format documents, subject to Terms and Conditions for Electronic Documents at www.sgs.com/terms_e-document.htm. Attention is drawn to the limitation of liability, indemnification and jurisdiction issues defined therein. Any holder of this document is advised that information contained hereon reflects the Company’s findings at the time of its intervention only and within the limits of Client’s instructions, if any. The Company’s sole responsibility is to its Client and this document does not exonerate parties to a transaction from exercising all their rights and obligations under the transaction documents. This document cannot be reproduced except in full, without prior written approval of the Company. Any unauthorized alteration, forgery or falsification of the content or appearance of this document is unlawful and offenders may be prosecuted to the fullest extent of the law. SGS Taiwan Ltd. No.134,WuKungRoad,NewTaipeiIndustrialPark,WukuDistrict,NewTaipeiCity,Taiwan24803/北北路134 t (8862) 22993279 f (8862) 22980488 www.tw.sgs.com Member of SGS Group APPENDIX 2 EXTERNAL PHOTOGRAPHS OF EUT Report No.: ER/2014/10004 FCC ID: 2AB7ET620 Issue Date: Apr. 11, 2014 Unless otherwise stated the results shown in this test report refer only to the sample(s) tested and such sample(s) are retained for 90 days only. 說留不 This document is issued by the Company subject to its General Conditions of Service printed overleaf, available on request or accessible at www.sgs.com/terms_and_conditions.htm and, for electronic format documents, subject to Terms and Conditions for Electronic Documents at www.sgs.com/terms_e-document.htm. Attention is drawn to the limitation of liability, indemnification and jurisdiction issues defined therein. Any holder of this document is advised that information contained hereon reflects the Company’s findings at the time of its intervention only and within the limits of Client’s instructions, if any. The Company’s sole responsibility is to its Client and this document does not exonerate parties to a transaction from exercising all their rights and obligations under the transaction documents. This document cannot be reproduced except in full, without prior written approval of the Company. Any unauthorized alteration, forgery or falsification of the content or appearance of this document is unlawful and offenders may be prosecuted to the fullest extent of the law. SGS Taiwan Ltd. No.134,WuKungRoad,NewTaipeiIndustrialPark,WukuDistrict,NewTaipeiCity,Taiwan24803/北北路134 t (8862) 22993279 f (8862) 22980488 www.tw.sgs.com Member of SGS Group Front View of EUT Back View of EUT Report No.: ER/2014/10004 FCC ID: 2AB7ET620 Issue Date: Apr. 11, 2014 Unless otherwise stated the results shown in this test report refer only to the sample(s) tested and such sample(s) are retained for 90 days only. 說留不 This document is issued by the Company subject to its General Conditions of Service printed overleaf, available on request or accessible at www.sgs.com/terms_and_conditions.htm and, for electronic format documents, subject to Terms and Conditions for Electronic Documents at www.sgs.com/terms_e-document.htm. Attention is drawn to the limitation of liability, indemnification and jurisdiction issues defined therein. Any holder of this document is advised that information contained hereon reflects the Company’s findings at the time of its intervention only and within the limits of Client’s instructions, if any. The Company’s sole responsibility is to its Client and this document does not exonerate parties to a transaction from exercising all their rights and obligations under the transaction documents. This document cannot be reproduced except in full, without prior written approval of the Company. Any unauthorized alteration, forgery or falsification of the content or appearance of this document is unlawful and offenders may be prosecuted to the fullest extent of the law. SGS Taiwan Ltd. No.134,WuKungRoad,NewTaipeiIndustrialPark,WukuDistrict,NewTaipeiCity,Taiwan24803/北北路134 t (8862) 22993279 f (8862) 22980488 www.tw.sgs.com Member of SGS Group Side View of EUT - 1 Side View of EUT - 2 Report No.: ER/2014/10004 FCC ID: 2AB7ET620 Issue Date: Apr. 11, 2014 Unless otherwise stated the results shown in this test report refer only to the sample(s) tested and such sample(s) are retained for 90 days only. 說留不 This document is issued by the Company subject to its General Conditions of Service printed overleaf, available on request or accessible at www.sgs.com/terms_and_conditions.htm and, for electronic format documents, subject to Terms and Conditions for Electronic Documents at www.sgs.com/terms_e-document.htm. Attention is drawn to the limitation of liability, indemnification and jurisdiction issues defined therein. Any holder of this document is advised that information contained hereon reflects the Company’s findings at the time of its intervention only and within the limits of Client’s instructions, if any. The Company’s sole responsibility is to its Client and this document does not exonerate parties to a transaction from exercising all their rights and obligations under the transaction documents. This document cannot be reproduced except in full, without prior written approval of the Company. Any unauthorized alteration, forgery or falsification of the content or appearance of this document is unlawful and offenders may be prosecuted to the fullest extent of the law. SGS Taiwan Ltd. No.134,WuKungRoad,NewTaipeiIndustrialPark,WukuDistrict,NewTaipeiCity,Taiwan24803/北北路134 t (8862) 22993279 f (8862) …

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Label Information_FCC ID: 2AB7ET620

Remote label FCCID: 2AB7ET620

Report No.: ER/2014/10004 FCC ID: 2AB7ET620 Issue Date: Apr. 11, 2014 Unless otherwise stated the results shown in this test report refer only to the sample(s) tested and such sample(s) are retained for 90 days only. 說留不 This document is issued by the Company subject to its General Conditions of Service printed overleaf, available on request or accessible at www.sgs.com/terms_and_conditions.htm and, for electronic format documents, subject to Terms and Conditions for Electronic Documents at www.sgs.com/terms_e-document.htm. Attention is drawn to the limitation of liability, indemnification and jurisdiction issues defined therein. Any holder of this document is advised that information contained hereon reflects the Company’s findings at the time of its intervention only and within the limits of Client’s instructions, if any. The Company’s sole responsibility is to its Client and this document does not exonerate parties to a transaction from exercising all their rights and obligations under the transaction documents. This document cannot be reproduced except in full, without prior written approval of the Company. Any unauthorized alteration, forgery or falsification of the content or appearance of this document is unlawful and offenders may be prosecuted to the fullest extent of the law. SGS Taiwan Ltd. No.134,WuKungRoad,NewTaipeiIndustrialPark,WukuDistrict,NewTaipeiCity,Taiwan24803/北北路134 t (8862) 22993279 f (8862) 22980488 www.tw.sgs.com Member of SGS Group APPENDIX 2 INTERNAL PHOTOGRAPHS OF EUT Report No.: ER/2014/10004 FCC ID: 2AB7ET620 Issue Date: Apr. 11, 2014 Unless otherwise stated the results shown in this test report refer only to the sample(s) tested and such sample(s) are retained for 90 days only. 說留不 This document is issued by the Company subject to its General Conditions of Service printed overleaf, available on request or accessible at www.sgs.com/terms_and_conditions.htm and, for electronic format documents, subject to Terms and Conditions for Electronic Documents at www.sgs.com/terms_e-document.htm. Attention is drawn to the limitation of liability, indemnification and jurisdiction issues defined therein. Any holder of this document is advised that information contained hereon reflects the Company’s findings at the time of its intervention only and within the limits of Client’s instructions, if any. The Company’s sole responsibility is to its Client and this document does not exonerate parties to a transaction from exercising all their rights and obligations under the transaction documents. This document cannot be reproduced except in full, without prior written approval of the Company. Any unauthorized alteration, forgery or falsification of the content or appearance of this document is unlawful and offenders may be prosecuted to the fullest extent of the law. SGS Taiwan Ltd. No.134,WuKungRoad,NewTaipeiIndustrialPark,WukuDistrict,NewTaipeiCity,Taiwan24803/北北路134 t (8862) 22993279 f (8862) 22980488 www.tw.sgs.com Member of SGS Group Open View of EUT -1 Open View of EUT -2 Report No.: ER/2014/10004 FCC ID: 2AB7ET620 Issue Date: Apr. 11, 2014 Unless otherwise stated the results shown in this test report refer only to the sample(s) tested and such sample(s) are retained for 90 days only. 說留不 This document is issued by the Company subject to its General Conditions of Service printed overleaf, available on request or accessible at www.sgs.com/terms_and_conditions.htm and, for electronic format documents, subject to Terms and Conditions for Electronic Documents at www.sgs.com/terms_e-document.htm. Attention is drawn to the limitation of liability, indemnification and jurisdiction issues defined therein. Any holder of this document is advised that information contained hereon reflects the Company’s findings at the time of its intervention only and within the limits of Client’s instructions, if any. The Company’s sole responsibility is to its Client and this document does not exonerate parties to a transaction from exercising all their rights and obligations under the transaction documents. This document cannot be reproduced except in full, without prior written approval of the Company. Any unauthorized alteration, forgery or falsification of the content or appearance of this document is unlawful and offenders may be prosecuted to the fullest extent of the law. SGS Taiwan Ltd. No.134,WuKungRoad,NewTaipeiIndustrialPark,WukuDistrict,NewTaipeiCity,Taiwan24803/北北路134 t (8862) 22993279 f (8862) 22980488 www.tw.sgs.com Member of SGS Group Internal of EUT – 1 Internal of EUT – 2 Report No.: ER/2014/10004 FCC ID: 2AB7ET620 Issue Date: Apr. 11, 2014 Unless otherwise stated the results shown in this test report refer only to the sample(s) tested and such sample(s) are retained for 90 days only. 說留不 This document is issued by the Company subject to its General Conditions of Service printed overleaf, available on request or accessible at www.sgs.com/terms_and_conditions.htm and, for electronic format documents, subject to Terms and Conditions for Electronic Documents at www.sgs.com/terms_e-document.htm. Attention is drawn to the limitation of liability, indemnification and jurisdiction issues defined therein. Any holder of this document is advised that information contained hereon reflects the Company’s findings at the time of its intervention only and within the limits of Client’s instructions, if any. The Company’s sole responsibility is to its Client and this document does not exonerate parties to a transaction from exercising all their rights and obligations under the transaction documents. This document cannot be reproduced except in full, without prior written approval of the Company. Any unauthorized alteration, forgery or falsification of the content or appearance of this document is unlawful and offenders may be prosecuted to the fullest extent of the law. SGS Taiwan Ltd. No.134,WuKungRoad,NewTaipeiIndustrialPark,WukuDistrict,NewTaipeiCity,Taiwan24803/北北路134 t (8862) 22993279 f (886…

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Report No.: ER/2014/10004 FCC ID: 2AB7ET620 Issue Date: Apr. 21, 2014 Page: 1 of 26 Unless otherwise stated the results shown in this test report refer only to the sample(s) tested and such sample(s) are retained for 90 days only. 說留不 This document is issued by the Company subject to its General Conditions of Service printed overleaf, available on request or accessible at www.sgs.com/terms_and_conditions.htm and, for electronic format documents, subject to Terms and Conditions for Electronic Documents at www.sgs.com/terms_e-document.htm. Attention is drawn to the limitation of liability, indemnification and jurisdiction issues defined therein. Any holder of this document is advised that information contained hereon reflects the Company’s findings at the time of its intervention only and within the limits of Client’s instructions, if any. The Company’s sole responsibility is to its Client and this document does not exonerate parties to a transaction from exercising all their rights and obligations under the transaction documents. This document cannot be reproduced except in full, without prior written approval of the Company. Any unauthorized alteration, forgery or falsification of the content or appearance of this document is unlawful and offenders may be prosecuted to the fullest extent of the law. SGS Taiwan Ltd. No.134,WuKungRoad,NewTaipeiIndustrialPark,WukuDistrict,NewTaipeiCity,Taiwan24803/北北路134 t (8862) 22993279 f (8862) 22980488 www.tw.sgs.com Member of SGS Group ELECTROMAGNETIC EMISSIONS COMPLIANCE REPORT INTENTIONAL RADIATOR CERTIFICATION TO FCC PART 15 SUBPART C REQUIREMENT OF Product Name: ISEsweat II sweat chloride analyzer Brand Name: N/A Model No.: ISEsweat II Model Difference: N/A FCC ID: 2AB7ET620 Report No.: ER/2014/10004 Issue Date: Apr. 21, 2014 FCC Rule Part: 15.249 Prepared for: TECNICAS CIENTÍFICAS PARA LABORATORIO S.A. LOPE DE VEGA, 99-101, 08005. BARCELONA -SPAIN Prepared by: SGS Taiwan Ltd. Electronics & Communication Laboratory No.134, Wu Kun g Road, New Taipei Industrial Park, Wuku District, New Taipei City, Taiwan 24803 Note: This report shall not be reproduced except in full, without the written approval of SGS Taiwan Ltd. This document may be altered or revised by SGS Taiwan Ltd. personnel only, and shall be noted in the revision section of the document. Report No.: ER/2014/10004 FCC ID: 2AB7ET620 Issue Date: Apr. 21, 2014 Page: 2 of 26 Unless otherwise stated the results shown in this test report refer only to the sample(s) tested and such sample(s) are retained for 90 days only. 說留不 This document is issued by the Company subject to its General Conditions of Service printed overleaf, available on request or accessible at www.sgs.com/terms_and_conditions.htm and, for electronic format documents, subject to Terms and Conditions for Electronic Documents at www.sgs.com/terms_e-document.htm. Attention is drawn to the limitation of liability, indemnification and jurisdiction issues defined therein. Any holder of this document is advised that information contained hereon reflects the Company’s findings at the time of its intervention only and within the limits of Client’s instructions, if any. The Company’s sole responsibility is to its Client and this document does not exonerate parties to a transaction from exercising all their rights and obligations under the transaction documents. This document cannot be reproduced except in full, without prior written approval of the Company. Any unauthorized alteration, forgery or falsification of the content or appearance of this document is unlawful and offenders may be prosecuted to the fullest extent of the law. SGS Taiwan Ltd. No.134,WuKungRoad,NewTaipeiIndustrialPark,WukuDistrict,NewTaipeiCity,Taiwan24803/北北路134 t (8862) 22993279 f (8862) 22980488 www.tw.sgs.com Member of SGS Group VERIFICATION OF COMPLIANCE Applicant: TECNICAS CIENTÍFICAS PARA LABORATORIO S.A. LOPE DE VEGA, 99-101, 08005. BARCELONA -SPAIN Product Description: ISEsweat II sweat chloride analyzer Brand Name: N/A Model No.: ISEsweat II FCC ID: 2AB7ET620 Model Difference: N/A File Number: ER/2014/10004 Date of test: Jan. 03, 2014 ~ Apr. 17, 2014 Date of EUT Received: Jan. 03, 2014 We hereby certify that: The above equipment was tested by SGS Taiwan Ltd., Electronics & Communication Laboratory. The test data, data evaluation, test procedures, and equipment configurations shown in this report were made in accordance with the procedures given in ANSI C63.4 2009 and the energy emitted by the sample EUT tested as described in this report is in compliance with conducted and radiated emission limits of FCC Rules Part 15.249. The test results of this report relate only to the tested sample identified in this report. Test By: Date: Apr. 21, 2014 Marcus Tseng / Engineer Prepared By: Date: Apr. 21, 2014 Violetta Tang / Clerk Approved By: Date: Apr. 21, 2014 Jim Chang / Supervisor Report No.: ER/2014/10004 FCC ID: 2AB7ET620 Issue Date: Apr. 21, 2014 Page: 3 of 26 Unless otherwise stated the results shown in this test report refer only to the sample(s) tested and such sample(s) are retained for 90 days only. 說留不 This document is issued by the Company subject to its General Conditions of Service printed overleaf, available on request or accessible at www.sgs.com/terms_and_conditions.htm and, for electronic format documents, subject to Terms and Conditions for Electronic Documents at www.sgs.com/terms_e-document.htm. Attention is drawn to the limitation of liability, indemnification and jurisdiction issues defined therein. Any holder of this document is advised that information contained hereon reflects the Company’s findings at the time of its intervention only and within the limits of Client’s instructions, if any. The Company’s sole responsibility is to its Client and this document does not exonerate parties to a transaction from exercising all their rights and obligations under the transaction documents. This document cannot be reproduced except in full, without pr…

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Report No.: ER/2014/10004 FCC ID: 2AB7ET620 Issue Date: Apr. 11, 2014 Unless otherwise stated the results shown in this test report refer only to the sample(s) tested and such sample(s) are retained for 90 days only. 說留不 This document is issued by the Company subject to its General Conditions of Service printed overleaf, available on request or accessible at www.sgs.com/terms_and_conditions.htm and, for electronic format documents, subject to Terms and Conditions for Electronic Documents at www.sgs.com/terms_e-document.htm. Attention is drawn to the limitation of liability, indemnification and jurisdiction issues defined therein. Any holder of this document is advised that information contained hereon reflects the Company’s findings at the time of its intervention only and within the limits of Client’s instructions, if any. The Company’s sole responsibility is to its Client and this document does not exonerate parties to a transaction from exercising all their rights and obligations under the transaction documents. This document cannot be reproduced except in full, without prior written approval of the Company. Any unauthorized alteration, forgery or falsification of the content or appearance of this document is unlawful and offenders may be prosecuted to the fullest extent of the law. SGS Taiwan Ltd. No.134,WuKungRoad,NewTaipeiIndustrialPark,WukuDistrict,NewTaipeiCity,Taiwan24803/北北路134 t (8862) 22993279 f (8862) 22980488 www.tw.sgs.com Member of SGS Group APPENDIX 1 PHOTOGRAPHS OF SETUP Report No.: ER/2014/10004 FCC ID: 2AB7ET620 Issue Date: Apr. 11, 2014 Unless otherwise stated the results shown in this test report refer only to the sample(s) tested and such sample(s) are retained for 90 days only. 說留不 This document is issued by the Company subject to its General Conditions of Service printed overleaf, available on request or accessible at www.sgs.com/terms_and_conditions.htm and, for electronic format documents, subject to Terms and Conditions for Electronic Documents at www.sgs.com/terms_e-document.htm. Attention is drawn to the limitation of liability, indemnification and jurisdiction issues defined therein. Any holder of this document is advised that information contained hereon reflects the Company’s findings at the time of its intervention only and within the limits of Client’s instructions, if any. The Company’s sole responsibility is to its Client and this document does not exonerate parties to a transaction from exercising all their rights and obligations under the transaction documents. This document cannot be reproduced except in full, without prior written approval of the Company. Any unauthorized alteration, forgery or falsification of the content or appearance of this document is unlawful and offenders may be prosecuted to the fullest extent of the law. SGS Taiwan Ltd. No.134,WuKungRoad,NewTaipeiIndustrialPark,WukuDistrict,NewTaipeiCity,Taiwan24803/北北路134 t (8862) 22993279 f (8862) 22980488 www.tw.sgs.com Member of SGS Group Radiated Emission Setup Photos Report No.: ER/2014/10004 FCC ID: 2AB7ET620 Issue Date: Apr. 11, 2014 Unless otherwise stated the results shown in this test report refer only to the sample(s) tested and such sample(s) are retained for 90 days only. 說留不 This document is issued by the Company subject to its General Conditions of Service printed overleaf, available on request or accessible at www.sgs.com/terms_and_conditions.htm and, for electronic format documents, subject to Terms and Conditions for Electronic Documents at www.sgs.com/terms_e-document.htm. Attention is drawn to the limitation of liability, indemnification and jurisdiction issues defined therein. Any holder of this document is advised that information contained hereon reflects the Company’s findings at the time of its intervention only and within the limits of Client’s instructions, if any. The Company’s sole responsibility is to its Client and this document does not exonerate parties to a transaction from exercising all their rights and obligations under the transaction documents. This document cannot be reproduced except in full, without prior written approval of the Company. Any unauthorized alteration, forgery or falsification of the content or appearance of this document is unlawful and offenders may be prosecuted to the fullest extent of the law. SGS Taiwan Ltd. No.134,WuKungRoad,NewTaipeiIndustrialPark,WukuDistrict,NewTaipeiCity,Taiwan24803/北北路134 t (8862) 22993279 f (8862) 22980488 www.tw.sgs.com Member of SGS Group Conducted Emission Set up Photos