2AZELADCP1P0WBCardio Pulmonary Management system

1 Version C DOC #: CFU0001 Revision C – March 2021 For assistance operating the CPM System, please contact Analog Devices: One Technology Way PO Box 9106 Norwood, MA 02062 USA (781) 329-4700 (800) 262-5643 DISCLAIMER: Information, operation, specifications, and product appearance may change without notice. SYMBOLS GLOSSARY: The symbols glossary is located at the end of this Instructions for Use guide READ ENTIRE INSTRUCTIONS FOR USE BEFORE OPERATING THE ADI CPM SYSTEM ADI CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM Clinician Instructions for Use – Device and Mobile Application 2 Version C Clinician Instructions for Use – Device and Mobile Application C Contents Glossary & Acronyms ................................................................................................................................................................ 4 Part 1. General System Information ................................................................................................................................. 6 1. Introduction ........................................................................................................................................................................ 6 2. Indications and Contraindications for Use ............................................................................................................... 6 3. Warnings and Precautions ................................................................................................................................................ 7 3.1 General ...............................................................................................................................................................7 3.2 Implant Information ...........................................................................................................................................9 3.3 Blood Thinner and Steroid Precautions ..............................................................................................................9 4. Detailed Description of the System ................................................................................................................................. 10 4.1 System Components ......................................................................................................................................... 10 CPM Device ............................................................................................................................................................. 10 Adhesive Disposables .............................................................................................................................................. 11 Alignment Tool ........................................................................................................................................................ 11 Base Station ............................................................................................................................................................. 12 Mobile Application .................................................................................................................................................. 12 Cloud Software ........................................................................................................................................................ 13 4.2 How the System Works ..................................................................................................................................... 13 4.3 Measurement Parameters ................................................................................................................................ 13 4.4 Parameter Thresholds ...................................................................................................................................... 16 4.5 Device Use and Duration .................................................................................................................................. 17 4.6 Device Placement and Location ........................................................................................................................ 17 Guidance for Correct Clinician Placement............................................................................................................... 18 Incorrect CPM Device Placements .......................................................................................................................... 20 Part 2. In-Clinic Instructions For Use .............................................................................................................................. 22 5. Getting Started ........................................................................................................................................................ 22 6. Baseline Measurement Preparation and Device Setup ................................................................................................... 22 6.1 Before meeting your patient for the baseline reading ..................................................................................... 22 6.2 Preparing the skin ............................................................................................................................................. 23 6.3 Fitting and sizing the CPM Device ..................................................................................................................... 23 6.4 Pairing the CPM Device to the Mobile App ...................................................................................................... 25 7. In-Clinic Setup and Baseline ................................................................................................................................... 26 7.1 Taking a Baseline Reading using the CPM Mobile App ..................................................................................... 27 3 Version C Clinician Instructions for Use – Device and Mobil…

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Actual Label in Wearable Label Location in Wearable: FCC ID: 2AZELADCP1P0WB

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1 Safety Human Exposure 1.1 Radio Frequency Exposure Compliance 1.1.1 Electromagnetic Fields RESULT: Pass Test Specification Test standard : CFR47 FCC Part 2: Section 2.1093 CFR47 FCC Part 1: Section 1.1310 FCC KDB Publication 447498 v06, section 7  FCC requirements a) EUT RF Exposure Evaluation operations Test Mode Maximum Measured conducted Power Threshold power @5mm Verdict dBm mW dBm mW BLE -4.72 0.337 10 10 Compliant

Prüfbericht – Produkte Test Report - Products Prüfbericht-Nr.: Test report no.: ULR-TC568821300000016F Auftrags-Nr.: Order no.: 166506457 0010 Seite 1 von 41 Page 1 of 41 Kunden-Referenz-Nr.: Client reference no.: NA Auftragsdatum: Order date: 2020-11-18 Auftraggeber: Client: Analog Devices Incorporated 9106, Norwood, Massachusetts, United States, 02062-9106 Prüfgegenstand: Test item: Cardio Pulmonary Management system Bezeichnung .: Identification .: ADCP1100-WB Serien -Nr.: Serial no.: 12345678901234567894 Auftrags-Inhalt: Order content: FCC Testing & Issue of Grant Prüfgrundlage: Test specification: FCC Part 15 Subpart C section 15.247 Wareneingangsdatum: Date of sample receipt: 2020.12.21 Prüfmuster-Nr.: Test sample no: A002973700-004 A002973700-005 Prüfzeitraum: Testing period: 2021-01-04 - 2021-01-15 Ort der Prüfung: Place of testing: Wireless Test Laboratory Prüflaboratorium: Testing laboratory: TÜV Rheinland (India) Pvt. Ltd, #27/B,2nd Cross Road, Electronic City Phase-1, Bengaluru-560100, India. FCC Test site registration number: 496599 ISED Test site registration number: 3466E-1 Prüfergebnis*: Test result*: Pass geprüft von: tested by: genehmigt von: authorized by: Datum: Date: 2021-03-26 Ausstellatum: Issue date: 2021-03-26 Stellung / Position: Madhu Karadekere Nagaraju Senior Engineer Stellung / Position: Mahammadgouse Kaladagi Assistant Manager Sonstiges / Other: FCC ID: 2AZELADCP1P0WB Zustand des Prüfgegenstandes bei Anlieferung: Condition of the test item at delivery: Prüfmuster vollständig und unbeschädigt Test item complete and undamaged * Legende: 1 = sehr gut 2 = gut 3 = befriedigend 4 = ausreichend 5 = mangelhaft P(ass) = entspricht o.g. Prüfgrundlage(n) F(ail) = entspricht nicht o.g. Prüfgrundlage(n) N/A = nicht anwendbar N/T = nicht getestet * Legend: 1 = very good 2 = good 3 = satisfactory 4 = sufficient 5 = poor P(ass) = passed a.m. test specification(s) F(ail) = failed a.m. test specification(s) N/A = not applicable N/T = not tested Dieser Prüfbericht bezieht sich nur auf das o.g. Prüfmuster und darf ohne Genehmigung der Prüfstelle nicht auszugsweise vervielfältigt werden. Dieser Bericht berechtigt nicht zur Verwendung eines Prüfzeichens. This test report only relates to the a. m. test sample. Without permission of the test center this test report is not permitted to be duplicated in extracts. This test report does not entitle to carry any test mark. TÜV Rheinland (India) Pvt. Ltd, Plot No.27/B, 2nd Cross, Electronic city, Industrial Area, Phase I, Hosur Road Bangalore-560 100, India Mail: [email protected] ∙ Web: www.ind.tuv.com Produkte Products www.tuv.com Prüfbericht - Nr.: Test Report No.: ULR-TC568821300000016F Seite 2 von 41 Page 2 of 41 TEST SUMMARY Test Item Applicable Standard Result FCC Maximum conducted (Peak) output power FCC 15.247(b)(3) Pass Maximum Power Spectral Density FCC 15.247(e) Pass DTS Bandwidth FCC 15.247(a)(2) Pass Emissions in non-restricted frequency bands FCC 15.247(d) Pass Spurious Radiated Emissions and Restricted Bands of Operation 15.247 (d) / (15.209 & 15.205) Pass Conducted Spurious Emission on ac Power lines FCC 15.207 Pass Product Category: Electronics Testing Test Discipline: EMC Test Facility Note: 1. *N/T Not Tested 2. This device is operated with CPM base station model number (ADCP1100-BS), with FCC ID : 2AZELADCP1P0BS . However testing is performed as stand-alone configuration without using CPM base station device. 3. The product CPM werable is battery operated however measurements to demonstrate compliance with the conducted limits is performed becouse the product obtaine it‘s power through another device (CPM base station) which is connected to the AC power lines. Produkte Products www.tuv.com Prüfbericht - Nr.: Test Report No.: ULR-TC568821300000016F Seite 3 von 41 Page 3 of 41 Table of Contents 1 GENERAL REMARKS ........................................................................................................................................... 4 1.1 Attachments .................................................................................................................................................. 4 2 TEST SITES .......................................................................................................................................................... 5 2.1 Testing Facilities............................................................................................................................................ 5 2.2 List of Test and Measurement Instruments ................................................................................................... 5 3 GENERAL PRODUCT INFORMATION ................................................................................................................. 6 3.1 Product Function and Intended Use.............................................................................................................. 6 3.2 Ratings and System Details of Equipment under Test ................................................................................. 6 3.3 Measurement Uncertainty: ............................................................................................................................ 7 4 TEST SET-UP AND OPERATION MODE ............................................................................................................. 8 4.1 Principle of Configuration Selection .............................................................................................................. 8 4.2 Test Operation and Test Software ................................................................................................................ 8 4.3 Special Accessories and Auxiliary Equipment .............................................................................................. 8 4.4 Countermeasures to achieve EMC Compliance ........................................................................................... 8 4.5 List of frequencies .......…

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Produkte Products www.tuv.com Test Setup Photos Reference Test Report No: ULR-TC5688213000000016F Seite 1 von 7 Page 1 of 7 Frequency range :9KHz–30MHz Polarization : Parallel Frequency range :9KHz–30MHz Polarization : Perpendicular Produkte Products www.tuv.com Test Setup Photos Reference Test Report No: ULR-TC5688213000000016F Seite 2 von 7 Page 2 of 7 Frequency range :30MHz–200MHz Polarization : Vertical Frequency range : 30MHz–200MHz Polarization : Horizontal Produkte Products www.tuv.com Test Setup Photos Reference Test Report No: ULR-TC5688213000000016F Seite 3 von 7 Page 3 of 7 Frequency range :200MHz–1GHz Polarization : Vertical Frequency range :200MHz–1GHz Polarization : Horizontal Produkte Products www.tuv.com Test Setup Photos Reference Test Report No: ULR-TC5688213000000016F Seite 4 von 7 Page 4 of 7 Frequency range :1GHz-18GHz Polarization : Vertical Frequency range :1GHz-18GHz Polarization : Horizontal Produkte Products www.tuv.com Test Setup Photos Reference Test Report No: ULR-TC5688213000000016F Seite 5 von 7 Page 5 of 7 Frequency range :18GHz-26GHz Polarization : Vertical Frequency range :18GHz-26GHz Polarization : Horizontal Produkte Products www.tuv.com Test Setup Photos Reference Test Report No: ULR-TC5688213000000016F Seite 6 von 7 Page 6 of 7 Radiated Test setup close-up Antenna Port Test Setup Photo Produkte Products www.tuv.com Test Setup Photos Reference Test Report No: ULR-TC5688213000000016F Seite 7 von 7 Page 7 of 7 Conducted Emission AC Power line Test Setup