2026-06-19T00:51:17+00:00 PD4ML. HTML to PDF Converter for Java (3113) PD4ML. HTML to PDF Converter for Java (3113) tetml={filename={D:\drim\repository\projects\drim_127_0\metadata\7\4\74851963587f14428c0102ac5e3f1667\74851963587f14428c0102ac5e3f1667.tet.xml} elements={annotations=false bookmarks=false destinations=false fields=false javascripts = false} } granularity=word contentanalysis={punctuationbreaks=false dehyphenate=false} layoutanalysis={tabledetect=0 layoutdetect=0} TITLE Prepared by Merrill, David Bionic Arm Rotator Joint Spec MODIFY, REPLACE OR DELETE ALL TEXT IN BLUE INCLUDING THIS STATEMENT BEFORE SUBMITTING FOR APPROVALS! Bionic Arm Rotator Joint Spec Document Properties Type: Mechanical Specification Status: Draft Document Number: DOC-12345 Revision: B Change Order: CO-123455 Created: 2019-08-28 15:55 Corbinsoft, The ALM Experts Date 2026-06-19 00:51 REVISION 182930 1 | Page Bionic Arm Rotator Joint Spec granularity=word contentanalysis={punctuationbreaks=false dehyphenate=false} layoutanalysis={tabledetect=0 layoutdetect=0} TITLE 1 Purpose [Example: The purpose of this document is to define the OP Block 79 Requirements for developing the Acme Medical Product ® ID Electroporation System] 2 Scope [Example: The scope of this document is to specify the timing, electrode pattern, and current requirements of OP Block 79. Timing is to include the time delay after trigger press, impedance pulse timing, Electroporation pulse timing, and the time in-between pulses] 3 Background [Define Mechanical Requirement and explain its functionality] 4 Definitions 4-1 - CFR: Code of Federal Regulations [This section will auto-populate as the acronyms are used in the document] 4-2 - ID: Intradermal 4-3 - OP Block: Defines the treatment sequence which includes impedance timing, drug delivery timing, pulse timing and associated voltage and current parameters, as well as the Electrode pin configuration 5 References [Retain blue references only if they are relevant. Add any necessary references.] 5-1 - QA-POL-004 Quality Manual 5-2 - Title 21 CFR Part 820 Quality System Regulation 5-3 - EN ISO 13485:2016 Medical Devices - Quality management systems – Requirements for regulatory purposes Prepared by Merrill, David Bionic Arm Rotator Joint Spec Corbinsoft, The ALM Experts Date 2026-06-19 00:51 REVISION 182930 5-4 - ISO 14971:2007 Medical devices - Application of risk management to medical devices 5-5 - EN ISO 14971:2012 Medical devices - Application of risk management to medical devices 5-6 - M11-003704-01 Software Requirement Specification, Acme Medical Product® ID 2 | Page Bionic Arm Rotator Joint Spec granularity=word contentanalysis={punctuationbreaks=false dehyphenate=false} layoutanalysis={tabledetect=0 layoutdetect=0} TITLE Prepared by Merrill, David Bionic Arm Rotator Joint Spec 6 Document Convention Each requirement has a requirement ID in the form of OPB ### where OPB indicates that it is a Operational Requirements for Acme Medical Product ID, and ### is a unique number indicating the specific requirement number. Corbinsoft, The ALM Experts When this document is updated and new requirements are added, the new requirements will begin with the next requirement ID number. The requirement numbers will not be duplicated. For example, if there is a requirement OPB, 12 there will not be another requirement OPB 12. If a requirement is requirement ID is deleted and is not reused. 7 Mechanical Requirement Requirements [Edit the below categories and turn them into headers as needed] Date 2026-06-19 00:51 Note: Mechanical Requirement Requirements DO NOT serve as risk mitigation. There are be no standalone Mechanical Requirement requirements; each is derived from a higher level requirement> Figure 1 Mechanical Requirement 79 Timing Diagram REVISION 182930 3 | Page Bionic Arm Rotator Joint Spec granularity=word contentanalysis={punctuationbreaks=false dehyphenate=false} layoutanalysis={tabledetect=0 layoutdetect=0} TITLE Prepared by Merrill, David Bionic Arm Rotator Joint Spec 7.1 Impedance Timing 7.1-1 - This impedance will be calculated every 50 ms. ID MDT.L-33021 Alternate Id MDT.L-MER:382 Status Draft Severity Should Have 7.1-2 - Contining 33021 ID MDT.L-36060 Alternate Id MDT.L-OPM-298 Status Draft Severity Should Have 7.2 Drug Delivery Timing 7.3 Pulse Timing 7.3.1 Voltage Parameters 7.3.2 Current Parameters 7.4 Electrode Pin Configuration Document Revision History Rev CO Number Description Effective 7.4-1 - There shall be a noise filter add on to the microphone. ID MDT.L-35005 Corbinsoft, The ALM Experts Date 2026-06-19 00:51 REVISION 182930 4 | Page Bionic Arm Rotator Joint Spec Date granularity=word contentanalysis={punctuationbreaks=false dehyphenate=false} layoutanalysis={tabledetect=0 layoutdetect=0} TITLE Prepared by Merrill, David Bionic Arm Rotator Joint Spec Alternate Id MDT.L-MER:408 Status Draft Severity Should Have Corbinsoft, The ALM Experts Date 2026-06-19 00:51 REVISION 182930 5 | Page Bionic Arm Rotator Joint Spec 0.20 0.20 1.00 0.00 0.00 0.00 0.00 0.20 0.40 0.50 0.50 0.50