2ATMT-MHEXH101Mammotome Revolve EX Holster

USER INSTRUCTIONS AND OPERATIONS GUIDE www.mammotome.com/ifu eIFU number: 001413 Table of Contents CHAPTER 1 INTRODUCTION ................................................................................................................................... 1-1 Indications ........................................................................................................................................................... 1-1 Contraindications ................................................................................................................................................ 1-1 Warnings ............................................................................................................................................................. 1-1 General ............................................................................................................................................................ 1-2 System ............................................................................................................................................................. 1-2 Control Module ............................................................................................................................................... 1-3 Holster ............................................................................................................................................................. 1-3 Probe ............................................................................................................................................................... 1-3 Training ............................................................................................................................................................... 1-4 System Components ........................................................................................................................................... 1-4 CHAPTER 2 SYSTEM DESCRIPTION ...................................................................................................................... 2-1 Overview—System Description .......................................................................................................................... 2-1 Control Module ............................................................................................................................................... 2-3 Cart ................................................................................................................................................................ 2-3 EX Holders (Cart Detachable Component)...................................................................................................... 2-4 ST Probe and Vacuum Tube Set ...................................................................................................................... 2-4 U/S Probe and Vacuum Tube Set .................................................................................................................... 2-7 EX Probe, Vacuum Tube Set, and Sleeve ........................................................................................................ 2-9 Input Devices ................................................................................................................................................ 2-11 Detachable Components .............................................................................................................................. 2-19 System Software ........................................................................................................................................... 2-20 CHAPTER 3 INITIAL INSTALLATION AND GETTING STARTED ................................................................................ 3-1 Preventative Maintenance .................................................................................................................................. 3-1 Unpacking/Assembling the Mammotome revolve Control Module................................................................... 3-1 Unpacking the Cart.............................................................................................................................................. 3-2 Unpacking the EX Holder (Cart Detachable Component) ................................................................................... 3-2 Placing the Control Module on the Cart ............................................................................................................. 3-2 Unpacking the Holster......................................................................................................................................... 3-3 Unpacking the Remote Footswitch ..................................................................................................................... 3-3 Unpacking the Remote Keypad ........................................................................................................................... 3-3 Setup ................................................................................................................................................................... 3-3 1. Powering on the Control Module ........................................................................................................... 3-3 2. Connecting the Holster to the Control Module ...................................................................................... 3-4 3. (OPTIONAL) Attaching the EX Holder (Cart Detachable Component) to the Cart .................................. 3-6 4. (OPTIONAL) Connecting the Remote Footswitch to the Control Module .............................................. 3-6 5. (OPTIONAL) Connecting the Remote Keypad to the Control Module .................................................... 3-6 6. Connecting the Vacuum Canister to the Control Module ...................................................................... 3-6 7. (OPTIONAL – EX ONLY) Connecting th…

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3.500±.015 .750±.015 TYP R.031 ARTWORK ZONE NOTES: MATERIAL: MUST CONFORM TO MAMMOTOME SPEC NUMBERS: 1. CM-000104 THERMAL TRANFER POLYESTER LABEL MATERIAL, (3M 7331/7860) WHITE W. GLOSS, 0.002" (3M300) PERMANENT PRESSURE SENSITIVE ADHESIVE, 0.001" CM-000208 LAMINATE, THERMAL TRANFER POLYESTER LABEL MATERIAL (3M7861), CLEAR, 0.002" (3M300) PERMANENT PRESSURE SENSITIVE ADHESIVE, 0.001" CM-000136, TONERS & DEVELOPERS FOR DIGITAL PRINTED LABELS ALL CORNERS TO BE 0.031" MINIMUM UNLESS OTHERWISE NOTED2. LOCATE ARTWORK PER ARTWORK FILE3. DENOTES INSPECTION DIMENSIONS4. PART NUMBERDESCRIPTIONARTWORK NUMBERPRODUCT CODE CC-000471-001LABEL, FLAG, TYPE BAW-000462COMMON CC-000471-002LABEL, FLAG, TYPE B w. BAR CODE SPACEAW-000493COMMON CC-000471-003LABEL, FLAG, BAR CODE SPACEAW-000495COMMON CC-000471-004LABEL, FLAG .075 X 3.5" AW-000757COMMON D C B A A B C D 1 2 3 4 5 6 7 8 8 7 6 5 4 3 2 1 THE INFORMATION CONTAINED IN THIS DRAWING IS THE SOLE PROPERTY OF MAMMOTOME. ANY REPRODUCTION IN PART OR AS A WHOLE WITHOUT THE WRITTEN PERMISSION OF MAMMOTOME IS PROHIBITED. UNLESS OTHERWISE SPECIFIED: DIMENSIONS ARE IN INCHES TOLERANCES: ANGULAR: 1/2° TWO PLACE DECIMAL .01 THREE PLACE DECIMAL .005 FOUR PLACE DECIMAL .0005 MATERIAL: TITLE: DWG. NO. SCALE: 1:1 LeRonda Perry SHEET 1 OF 1 DATE: INTERPRET GEOMETRIC TOLERANCING PER: ASME Y14.5-2009 PROPRIETARY AND CONFIDENTIAL 03/09/2012 Lifecycle: Production ReviseLifecycle State: Released ECN Number: ECN-000405Release Date: 04/19/2013Effective Date: 04/19/2013 Drawing Revision: C CC-000471 B DRAWN BY: SEE NOTES SIZE LABEL, FLAG .075 X 3.5" PCR Number: N/A

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A Company: Devicor Medical Products, Inc. Page 1 of 23 Name: Revolve Control Module with EX Holster Report: TR 318353 D Model: MHEXH1 Job: C-3148 Serial: MHEXH1000001, MHEXH1000002 Test Report # 318353 D Equipment Under Test: Revolve Control Module with EX Holster Test Date(s): March 28 th – May 17 th , 2019 Prepared for: Devicor Medical Products, Inc. Attn: Kyle Wagner 300 E-Business Way, Fifth Floor Cincinnati, OH 45241 Report Issued by: Zach Wilson, EMC Engineer Signature: Date: Report Reviewed by: Adam Alger, Quality Manager Signature: Date: Report Constructed by: Zach Wilson, EMC Engineer Signature: Date: 5/14/2019 This test report may not be reproduced, except in full, without approval of Laird Technologies, Inc. Company: Devicor Medical Prodcuts, Inc. Page 2 of 23 Name: Revolve Control Module with EX Holster Report: TR 318353 D Model: MHEXH1 Job: C-3148 Serial: MHEXH1000001, MHEXH1000002 CONTENTS Contents ........................................................................................................................................................ 2 Laird Technologies Test Services in Review .............................................................................................. 3 1 Test Report Summary ........................................................................................................................... 4 2 Client Information ................................................................................................................................. 5 2.1 Equipment Under Test (EUT) Information .................................................................................... 5 2.2 Product Description ...................................................................................................................... 5 2.3 Modifications Incorporated for Compliance ................................................................................. 6 2.4 Deviations and Exclusions from Test Specifications ..................................................................... 6 2.5 Mode of Operation – Active Biopsy .............................................................................................. 6 2.6 Radio Programming Information .................................................................................................. 6 2.7 Software Versions ......................................................................................................................... 6 3 References ............................................................................................................................................ 7 4 Uncertainty Summary ........................................................................................................................... 8 5 Test Data ............................................................................................................................................... 9 5.1 Radiated Emissions ....................................................................................................................... 9 5.2 AC Mains Conducted Emissions .................................................................................................. 18 6 Revision History .................................................................................................................................. 23 Company: Devicor Medical Prodcuts, Inc. Page 3 of 23 Name: Revolve Control Module with EX Holster Report: TR 318353 D Model: MHEXH1 Job: C-3148 Serial: MHEXH1000001, MHEXH1000002 Laird Technologies Test Services in Review The Laird Technologies, Inc. laboratory located at W66 N220 Commerce Court Cedarburg, Wisconsin, 53012 USA is recognized through the following organizations: A2LA – American Association for Laboratory Accreditation Accreditation based on ISO/IEC 17025:2017 with Electrical (EMC) Scope A2LA Certificate Number: 1255.01 Scope of accreditation includes all test methods listed herein unless otherwise noted Federal Communications Commission (FCC) – USA Accredited Test Firm Registration Number: 953492 Recognition of two 3 meter Semi-Anechoic Chambers Innovation, Science and Economic Development Canada Accredited U.S. Identification Number: US0218 Recognition of two 3 meter Semi-Anechoic Chambers Company: Devicor Medical Prodcuts, Inc. Page 4 of 23 Name: Revolve Control Module with EX Holster Report: TR 318353 D Model: MHEXH1 Job: C-3148 Serial: MHEXH1000001, MHEXH1000002 1 TEST REPORT SUMMARY During March 28 th – May 17 th , 2019 the Equipment Under Test (EUT), Revolve Control Module with EX Holster, as provided by Devicor Medical Products Inc. was tested to the following requirements of the Federal Communications Commission and Innovation, Science and Economic Development Canada: Requirements Description Specification Method Compliant FCC: 15.209 (c) IC: RSS-GEN (8.9) Radiated Emissions 1-13.11 MHz, 14.010 – 1000 MHz 29.5 dBμV/m @ 30m ANSI C63.10 Yes FCC: 15.225 (a) IC: RSS-210 (B.6) Radiated Emissions 13.110-14.010 MHz 84 dBμV/m @ 30m ANSI C63.10 Yes FCC: 15.207 (a) IC: RSS-GEN (8.8) Conducted AC Emissions See Section 5.2.1 ANSI C63.10 Yes FCC: 2.1049 IC: RSS-GEN (6.7) Occupied Bandwidth Reported ANSI C63.10 Reported FCC: 15.225 (e) IC: RSS-210 (B.6) Carrier Frequency Stability ±0.01% ANSI C63.10 Yes Notice: The results relate only to the item tested as configured and described in this report. Any additional configurations, modes of operation, or modifications made to the equipment under test after the specified test date(s) are at the decision of the client and may not apply to the data seen in this test report. The decision rule for Pass / Fail assessment to the specification or standard listed in this test report has been agreed upon by the client and laboratory to be as follows: Measurement Type Rule Emissions – Amplitude 1 dB below specified limit Emissions – Frequency 1% less than the specification Immunity Tested at specified level Company: Devicor Medical Prodcuts, Inc…

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Laird Technologies, Inc. • W66 N220 Commerce Court Cedarburg, Wisconsin 53012 • 262.375.4400 Company: Devicor Medical Products, Inc. Page 1 of 3 Name: Revolve Control Module with EX Holster FCC ID: 2ATMT-MHEXH101 Model: MHEXH1 IC ID: 25143-MHEXH101 Serial: MHEXH1000001, MHEXH1000002 Photos Radiated Emissions 1-30 MHz Radiated Emissions 1-30 MHz Radiated Emissions EUT Radiated Emissions 30-200 MHz Radiated Emissions 200-1000 MHz Radiated Emission Over 1 GHz Laird Technologies, Inc. • W66 N220 Commerce Court Cedarburg, Wisconsin 53012 • 262.375.4400 Company: Devicor Medical Products, Inc. Page 2 of 3 Name: Revolve Control Module with EX Holster FCC ID: 2ATMT-MHEXH101 Model: MHEXH1 IC ID: 25143-MHEXH101 Serial: MHEXH1000001, MHEXH1000002 Frequency Stability, OBW Frequency Stability, OBW Conducted AC Emissions Conducted AC Emissions Antenna – Skew Polarity Antenna – Parallel Polarity Laird Technologies, Inc. • W66 N220 Commerce Court Cedarburg, Wisconsin 53012 • 262.375.4400 Company: Devicor Medical Products, Inc. Page 3 of 3 Name: Revolve Control Module with EX Holster FCC ID: 2ATMT-MHEXH101 Model: MHEXH1 IC ID: 25143-MHEXH101 Serial: MHEXH1000001, MHEXH1000002 Antenna – Perpendicular Polarity Close up of EUT EUT Placement