2026-06-19T00:51:17+00:00 PD4ML. HTML to PDF Converter for Java (3113) PD4ML. HTML to PDF Converter for Java (3113) engines={image=false textcolor=true vector=false text=true} tetml={filename={D:\drim\repository\projects\drim_127_0\metadata\7\4\74851963587f14428c0102ac5e3f1667\74851963587f14428c0102ac5e3f1667.para.xml} elements={annotations=false bookmarks=false destinations=false fields=false javascripts=false} } granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} Corbinsoft, C o r b i n s o f t , The T h e ALM A L M Experts E x p e r t s Prepared P r e p a r e d by b y Merrill, M e r r i l l , David D a v i d Date D a t e 2026-06-19 2 0 2 6 - 0 6 - 1 9 00:51 0 0 : 5 1 REVISION R E V I S I O N 182930 1 8 2 9 3 0 TITLE T I T L E Bionic B i o n i c Arm A r m Rotator R o t a t o r Joint J o i n t Spec S p e c MODIFY, M O D I F Y , REPLACE R E P L A C E OR O R DELETE D E L E T E ALL A L L TEXT T E X T IN I N BLUE B L U E INCLUDING I N C L U D I N G THIS T H I S STATEMENT S T A T E M E N T BEFORE B E F O R E SUBMITTING S U B M I T T I N G FOR F O R APPROVALS! A P P R O V A L S ! Bionic B i o n i c Arm A r m Rotator R o t a t o r Joint J o i n t Spec S p e c Document D o c u m e n t Properties P r o p e r t i e s Type: T y p e : Mechanical M e c h a n i c a l Specification S p e c i f i c a t i o n Status: S t a t u s : Draft D r a f t Document D o c u m e n t Number: N u m b e r : DOC-12345 D O C - 1 2 3 4 5 Revision: R e v i s i o n : B B Change C h a n g e Order: O r d e r : CO-123455 C O - 1 2 3 4 5 5 Created: C r e a t e d : 2019-08-28 2 0 1 9 - 0 8 - 2 8 15:55 1 5 : 5 5 1 1 | | Page P a g e Bionic B i o n i c Arm A r m Rotator R o t a t o r Joint J o i n t Spec S p e c granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} Corbinsoft, C o r b i n s o f t , The T h e ALM A L M Experts E x p e r t s Prepared P r e p a r e d by b y Merrill, M e r r i l l , David D a v i d Date D a t e 2026-06-19 2 0 2 6 - 0 6 - 1 9 00:51 0 0 : 5 1 REVISION R E V I S I O N 182930 1 8 2 9 3 0 TITLE T I T L E Bionic B i o n i c Arm A r m Rotator R o t a t o r Joint J o i n t Spec S p e c 1 1 Purpose P u r p o s e [Example: [ E x a m p l e : The T h e purpose p u r p o s e of o f this t h i s document d o c u m e n t is i s to t o define d e f i n e the t h e OP O P Block B l o c k 79 7 9 Requirements R e q u i r e m e n t s for f o r developing d e v e l o p i n g the t h e Acme A c m e Medical M e d i c a l Product P r o d u c t ® ® ID I D Electroporation E l e c t r o p o r a t i o n System] S y s t e m ] 2 2 Scope S c o p e [Example: [ E x a m p l e : The T h e scope s c o p e of o f this t h i s document d o c u m e n t is i s to t o specify s p e c i f y the t h e timing, t i m i n g , electrode e l e c t r o d e pattern, p a t t e r n , and a n d current c u r r e n t requirements r e q u i r e m e n t s of o f OP O P Block B l o c k 79. 7 9 . Timing T i m i n g is i s to t o include i n c l u d e the t h e time t i m e delay d e l a y after a f t e r trigger t r i g g e r press, p r e s s , impedance i m p e d a n c e pulse p u l s e timing, t i m i n g , Electroporation E l e c t r o p o r a t i o n pulse p u l s e timing, t i m i n g , and a n d the t h e time t i m e in-between i n - b e t w e e n pulses] p u l s e s ] 3 3 Background B a c k g r o u n d [Define [ D e f i n e Mechanical M e c h a n i c a l Requirement R e q u i r e m e n t and a n d explain e x p l a i n its i t s functionality] f u n c t i o n a l i t y ] 4 4 Definitions D e f i n i t i o n s 4-1 4 - 1 - - CFR: C F R : Code C o d e of o f Federal F e d e r a l Regulations R e g u l a t i o n s [This [ T h i s section s e c t i o n will w i l l auto-populate a u t o - p o p u l a t e as a s the t h e acronyms a c r o n y m s are a r e used u s e d in i n the t h e document] d o c u m e n t ] 4-2 4 - 2 - - ID: I D : Intradermal I n t r a d e r m a l 4-3 4 - 3 - - OP O P Block: B l o c k : Defines D e f i n e s the t h e treatment t r e a t m e n t sequence s e q u e n c e which w h i c h includes i n c l u d e s impedance i m p e d a n c e timing, t i m i n g , drug d r u g delivery d e l i v e r y timing, t i m i n g , pulse p u l s e timing t i m i n g and a n d associated a s s o c i a t e d voltage v o l t a g e and a n d current c u r r e n t parameters, p a r a m e t e r s , as a s well w e l l as a s the t h e Electrode E l e c t r o d e pin p i n configuration c o n f i g u r a t i o n 5 5 References R e f e r e n c e s [Retain [ R e t a i n blue b l u e references r e f e r e n c e s only o n l y if i f they t h e y are a r e relevant. r e l e v a n t . Add A d d any a n y necessary n e c e s s a r y references.] r e f e r e n c e s . ] 5-1 5 - 1 - - QA-POL-004 Q A - P O L - 0 0 4 Quality Q u a l i t y Manual M a n u a l 5-2 5 - 2 - - Title T i t l e 21 2 1 CFR C F R Part P a r t 820 8 2 0 Quality Q u a l i t y System S y s t e m Regulation R e g u l a t i o n 5-3 5 - 3 - - EN E N ISO I S O 13485:2016 1 3 4 8 5 : 2 0 1 6 Medical M e d i c a l Devices D e v i c e s - - Quality Q u a l i t y management m a n a g e m e n t systems s y s t e m s – – Requirements R e q u i r e m e n t s for f o r regulatory r e g u l a t o r y purposes p u r p o s e s 5-4 5 - 4 - - ISO I S O 14971:2007 1 4 9 7 1 : 2 0 0 7 Medical M e d i c a l devices d e v i c e s - - Application A p p l i c a t i o n of o f risk r i s k management m a n a g e m e n t to t o medical m e d i c a l devices d e v i c e s 5-5 5 - 5 - - EN E N ISO I S O 14971:2012 1 4 9 7 1 : 2 0 1 2 Medical M e d i c a l devices d e v i c e s - - Application A p p l i c a t i o n of o f risk r i s k management m a n a g e m e n t to t o medical m e d i c a l devices d e v i c e s 5-6 5 - 6 - - M11-003704-01 M 1 1 - 0 0 3 7 0 4 - 0 1 Software S o f t w a r e Requirement R e q u i r e m e n t Specification, S p e c i f i c a t i o n , Acme A c m e Medical M e d i c a l Product® P r o d u c t ® ID I D 2 2 | | Page P a g e Bionic B i o n i c Arm A r m Rotator R o t a t o r Joint J o i n t Spec S p e c granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} Corbinsoft, C o r b i n s o f t , The T h e ALM A L M Experts E x p e r t s Prepared P r e p a r e d by b y Merrill, M e r r i l l , David D a v i d Date D a t e 2026-06-19 2 0 2 6 - 0 6 - 1 9 00:51 0 0 : 5 1 REVISION R E V I S I O N 182930 1 8 2 9 3 0 TITLE T I T L E Bionic B i o n i c Arm A r m Rotator R o t a t o r Joint J o i n t Spec S p e c 6 6 Document D o c u m e n t Convention C o n v e n t i o n Each E a c h requirement r e q u i r e m e n t has h a s a a requirement r e q u i r e m e n t ID I D in i n the t h e form f o r m of o f OPB O P B ### # # # where w h e r e OPB O P B indicates i n d i c a t e s that t h a t it i t is i s a a Operational O p e r a t i o n a l Requirements R e q u i r e m e n t s for f o r Acme A c m e Medical M e d i c a l Product P r o d u c t ID, I D , and a n d ### # # # is i s a a unique u n i q u e number n u m b e r indicating i n d i c a t i n g the t h e specific s p e c i f i c requirement r e q u i r e m e n t number. n u m b e r . When W h e n this t h i s document d o c u m e n t is i s updated u p d a t e d and a n d new n e w requirements r e q u i r e m e n t s are a r e added, a d d e d , the t h e new n e w requirements r e q u i r e m e n t s will w i l l begin b e g i n with w i t h the t h e next n e x t requirement r e q u i r e m e n t ID I D number. n u m b e r . The T h e requirement r e q u i r e m e n t numbers n u m b e r s will w i l l not n o t be b e duplicated. d u p l i c a t e d . For F o r example, e x a m p l e , if i f there t h e r e is i s a a requirement r e q u i r e m e n t OPB, O P B , 12 1 2 there t h e r e will w i l l not n o t be b e another a n o t h e r requirement r e q u i r e m e n t OPB O P B 12. 1 2 . If I f a a requirement r e q u i r e m e n t is i s requirement r e q u i r e m e n t ID I D is i s deleted d e l e t e d and a n d is i s not n o t reused. r e u s e d . 7 7 Mechanical M e c h a n i c a l Requirement R e q u i r e m e n t Requirements R e q u i r e m e n t s [Edit [ E d i t the t h e below b e l o w categories c a t e g o r i e s and a n d turn t u r n them t h e m into i n t o headers h e a d e r s as a s needed] n e e d e d ] Note: N o t e : Mechanical M e c h a n i c a l Requirement R e q u i r e m e n t Requirements R e q u i r e m e n t s DO D O NOT N O T serve s e r v e as a s risk r i s k mitigation. m i t i g a t i o n . There T h e r e are a r e be b e no n o standalone s t a n d a l o n e Mechanical M e c h a n i c a l Requirement R e q u i r e m e n t requirements; r e q u i r e m e n t s ; each e a c h is i s derived d e r i v e d from f r o m a a higher h i g h e r level l e v e l requirement> r e q u i r e m e n t > Figure F i g u r e 1 1 Mechanical M e c h a n i c a l Requirement R e q u i r e m e n t 79 7 9 Timing T i m i n g Diagram D i a g r a m 3 3 | | Page P a g e Bionic B i o n i c Arm A r m Rotator R o t a t o r Joint J o i n t Spec S p e c granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} Corbinsoft, C o r b i n s o f t , The T h e ALM A L M Experts E x p e r t s Prepared P r e p a r e d by b y Merrill, M e r r i l l , David D a v i d Date D a t e 2026-06-19 2 0 2 6 - 0 6 - 1 9 00:51 0 0 : 5 1 REVISION R E V I S I O N 182930 1 8 2 9 3 0 TITLE T I T L E Bionic B i o n i c Arm A r m Rotator R o t a t o r Joint J o i n t Spec S p e c 7.1 7 . 1 Impedance I m p e d a n c e Timing T i m i n g 7.1-1 7 . 1 - 1 - - This T h i s impedance i m p e d a n c e will w i l l be b e calculated c a l c u l a t e d every e v e r y 50 5 0 ms. m s . ID I D MDT.L-33021 M D T . L - 3 3 0 2 1 Alternate A l t e r n a t e Id I d MDT.L-MER:382 M D T . L - M E R : 3 8 2 Status S t a t u s Draft D r a f t Severity S e v e r i t y Should S h o u l d Have H a v e 7.1-2 7 . 1 - 2 - - Contining C o n t i n i n g 33021 3 3 0 2 1 ID I D MDT.L-36060 M D T . L - 3 6 0 6 0 Alternate A l t e r n a t e Id I d MDT.L-OPM-298 M D T . L - O P M - 2 9 8 Status S t a t u s Draft D r a f t Severity S e v e r i t y Should S h o u l d Have H a v e 7.2 7 . 2 Drug D r u g Delivery D e l i v e r y Timing T i m i n g 7.3 7 . 3 Pulse P u l s e Timing T i m i n g 7.3.1 7 . 3 . 1 Voltage V o l t a g e Parameters P a r a m e t e r s 7.3.2 7 . 3 . 2 Current C u r r e n t Parameters P a r a m e t e r s 7.4 7 . 4 Electrode E l e c t r o d e Pin P i n Configuration C o n f i g u r a t i o n Document D o c u m e n t Revision R e v i s i o n History H i s t o r y Rev R e v CO C O Number N u m b e r Description D e s c r i p t i o n Effective E f f e c t i v e Date D a t e 7.4-1 7 . 4 - 1 - - There T h e r e shall s h a l l be b e a a noise n o i s e filter f i l t e r add a d d on o n to t o the t h e microphone. m i c r o p h o n e . ID I D MDT.L-35005 M D T . L - 3 5 0 0 5 4 4 | | Page P a g e Bionic B i o n i c Arm A r m Rotator R o t a t o r Joint J o i n t Spec S p e c granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} Corbinsoft, C o r b i n s o f t , The T h e ALM A L M Experts E x p e r t s Prepared P r e p a r e d by b y Merrill, M e r r i l l , David D a v i d Date D a t e 2026-06-19 2 0 2 6 - 0 6 - 1 9 00:51 0 0 : 5 1 REVISION R E V I S I O N 182930 1 8 2 9 3 0 TITLE T I T L E Bionic B i o n i c Arm A r m Rotator R o t a t o r Joint J o i n t Spec S p e c Alternate A l t e r n a t e Id I d MDT.L-MER:408 M D T . L - M E R : 4 0 8 Status S t a t u s Draft D r a f t Severity S e v e r i t y Should S h o u l d Have H a v e 5 5 | | Page P a g e Bionic B i o n i c Arm A r m Rotator R o t a t o r Joint J o i n t Spec S p e c 0.20 0.20 1.00 0.00 0.00 0.00 0.00 0.20 0.40 0.50 0.50 0.50